Invivo 3GSPO2 Wireless SpO2 for Patient Monitoring in MRI Environments User Manual 989803193211

Invivo Corporation Wireless SpO2 for Patient Monitoring in MRI Environments 989803193211

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3GSPO2 User Manual

Manual

Expression MR400 MRI Patient Monitoring System

INSTRUCTIONS FOR USE

Revision A

English

*989803193211*

989803193211

Manufacturer

Invivo,adivisionofPhilipsMedicalSystems

12151ResearchParkway

Orlando,FL32826,USA

877‐468‐4861

E‐mail:

Info@invivocorp.com

Websites:

www.ExpressionMR.com

www.invivocorp.com

www.philips.com

Identification and Publication Details

PublishedbyInvivo,adivisionofPhilipsMedicalSystems.

Invivo,adivisionofPhilipsMedicalSystems,reservestherighttomakechangestoboththis

InstructionsforUseandtotheproductitdescribes.Productspecificationsaresubjecttochange

withoutnotice.NothingcontainedwithinthisInstructionsforUseisintendedasanyoffer,

warranty,promiseorcontractualcondition,andmustnotbetakenassuch.

©KoninklijkePhilipsN.V.(RoyalPhilips)2015

Allrightsreserved.Reproductioninwholeorinpartinanyformorbyanymeans,electrical,

mechanicalorotherwiseisprohibitedwithoutthewrittenconsentofthecopyrightholder.

REF989803193211Rev.A,March2015

Invivo,adivisionofPhilipsMedicalSystems

12151ResearchParkway

Orlando,FL32826

USA

Unauthorizedcopyingofthispublicationmaynotonlyinfringecopyright,butalsoreducethe

abilityofPhilipsMedicalSystemstoprovideaccurateandup‐to‐dateinformationtousers.

PublishedinUSA

iii

Regulatory

Compliance

TheExpressionMR400MRIPatientMonitoringSystemcomplieswithrelevantinternationaland

nationalstandardsandlaws.Informationoncompliancewillbesuppliedonrequestbyyourlocal

RoyalPhilipsrepresentative,orbythemanufacturer.

Explanation of Symbols

ThesymbolsinthefollowingtablemayappearontheExpressionMR400MRIPatientMonitoring

System,theaccessories,orthepackingmaterial.

Symbol Symbol

Underwriters

Laboratories Component

Recognition Mark for both

the U.S. and Canadian

markets

Federal Communications

Commission radio

certification

Ministry of Internal Affairs

and Communications

Japanese Radio Law

Certification

UL has determined that

the product meets

requirements

Korean Communications

Commission radio

certification

Taiwan National

Communications

Commission certification

Conforms to the

European Medical Devices

Directive

Conforms to the R&TTE

Directive (Radio &

Telecommunications

Terminal Equipment)

Authorized representative

in the European

Community

Serial number

Catalog, reorder or

reference part number Batch code / lot number

Sterilized using radiation Unique device identifier

Sterilized using ethylene

oxide

In vitro diagnostics

compliant

MR Conditional: Use in

the MR environment is

restricted to certain

conditions of use to

ensure patient and

operator safety.

MR unsafe: Must not be

used in an MRI

environment

MR safe: Completely safe

for use with no potential

for interaction with the

MR field.

Warning! Specific warnings

associated with the

devices that are not

otherwise found on the

label; and, on the

connector of the wireless

ECG patient module, this

indicates that only

specified ECG lead cables

shall be used to ensure

safe use in the MR and

defibrillation protection.

Consult the Instructions for

Use

Caution! See Instructions

for Use for specific

warnings or precautions

associated with the

devices that are not

otherwise found on the

label

The Instructions for Use

must be consulted

Separate to open then

insert

Do not adjust without

referring to the service

manual

Single use only, disposable

one-time-use product; do

not reuse

Do not use if container is

damaged

Defibrillator-proof type

CF equipment (IEC 60601-

1) protection against

shock

Symbol Symbol

Use by date; do not use

after the year (YYYY),

month (MM) and day

(DD) indicated

Cable tag marked with use

by date; do not use after

the year (YYYY) and

month (MM) indicated

Use by date; do not use

after the year (YYYY),

month (MM)

AC receptacle, below

Do not push Correct

Alternating current Not sterile

SPO2 probe quantity

equals Direct current

Adult SPO2 clip quantity

equals

Pediatric SPO2 clip

quantity equals

Infant SPO2 grip quantity

equals

Neonatal SPO2 grip

quantity equals

Adult SPO2 grip quantity

equals

Pediatric SPO2 grip

quantity equals

Infant Neonate

Toe site Thumb site

Finger site Big toe site

Symbol Symbol

YYYY-MM-DD

YYYY-MM

Prescription only Foot site

NIBP cuff, correct side out Temperature range

Non-pyrogenic fluid path NIBP cuff, wrong side out

Airway adapter quantity

equals

NIBP cuff circumference

range

Anesthetic oxygen (O2)

sensor location and part

number

IBP transducer cable

quantity equals

Weight Cannula quantity equals

Humidity range Humidity range, non

condensing

For indoor use only Equipotential (earth)

ground

Fragile Keep dry

Symbol Symbol

vii

Keep away from heat Atmospheric pressure

limitation

Packages per box Up

Quantity equals

Non-invasive blood

pressure (NIBP)

connection

Not manufactured with

natural latex rubber Quadtrode electrode

Contains or presence of

phthalate: bis (2-

ethylhexyl) phthalate

Quadtrode electrode per

package

Non-ionizing radiation ECG

AAMI ECG CV lead cable

connections

AAMI ECG lead cable

connections

AAMI ECG NEO lead

cable connections

IEC ECG CV lead cable

connections

IEC ECG lead cable

connections

IEC ECG NEO lead cable

connections

Symbol Symbol

viii

Cardiac gating output Universal Serial Bus (USB)

Conforms to the RoHS

directive Not for general waste

Center positive

connection: Positive (+)

center pin, negative (-)

outer ring

Pneumatic respiration

connection

Gas input indicator Gas output indicator

Electrical input indicator Electrical output indicator

Temperature connection Electrostatic discharge

(ESD) warning

Manufacturer name and

address YYYY-MM

Date of manufacture

(year-month)

Non-magnetic part Battery

Main battery (left side) Main battery (right side)

Symbol Symbol

Do not move the

Expression MR400 MRI

Patient Monitoring System

inside the 5000 gauss field

line of the MR magnet or

up to the face of a 3T

magnet, whichever is

greater, as measured from

the center line of the

bore.

Apply wheel locks and do

not move the Expression

MR400 MRI Patient

Monitoring System inside

the 5000 gauss field line of

the MR magnet or up to

the face of a 3T magnet,

whichever is greater, as

measured from the center

line of the bore.

Charge indicator, cart

battery Wheel lock

Power level button, cart

battery

MRI compatible, up to

2500 gauss

Setup key Main Screen key

Zero All key Print key, printer ready

indication

Clear Trends key

Print key, printing in

process (and time

remaining) indication

NIBP Interval key Print key, no printer

available indication

1-Touch Alarms key Print key, printer error

indication

Suspend key Trends key

NIBP Start/Stop key ECG Filter key

Connected to AC mains Audio Pause key

Alarm audio armed Alarm key

Symbol Symbol

Alarm audio paused

After opening, allow at

least 1 hour to pass before

use

Alarm audio off Current setups have

changed

Power switch (Standby

switch) Heartbeat detected

Module battery adequate

charge indication Breathing effort detected

Module battery low

charge indication

Battery 1 indicator,

wireless ECG patient

module,

Battery 2 indicator,

wireless ECG patient

module,

Battery indicator, wireless

SpO2 patient module

No communication IP5 connected

Network channel 1 Network channel 6

Network channel 2 Network channel 7

Network channel 3 Network channel 8

Network channel 4 Network channel 9

Symbol Symbol

Conventions

CertainconventionsareusedthroughouttheExpressionMR400MRIPatientMonitoringSystem

tospeeduseandfamiliaritywiththedevice.Thisaccompanyinguserinformationalsouses

documentconventionstoassistyouinfindingandunderstandinginformation.

System Conventions

Thefollowingsystemconventionsareused:

•Operationalcontrolisaccomplishedusingthetouchscreen,whereactiveelementsare

providedandtouchingthatelementwillactivate,openorexecutetherelatedmenu,

functionoritem.

•Mostmenusemployatime‐outfeaturewhere,ifnoactionistakenforapproximately30–

60seconds,anopenmenuwillautomaticallyclose.

•Toprotectagainstaccidentalchanges,adialogpromptisassociatedwithsomemenu

options.Whendisplayed,youmustanswerthisprompt;otherwise,adelayof

approximately30–60secondswillbeequivalenttoselectingNo(thiscanalsobe

accomplishedbypressingtheMainScreenkey.)

•Toprotectagainstunauthorizedchanges,somemenuitemsfeaturepasswordprotection.

Youmustenterthecorrectnumericcodeforaccessandadelayofapproximately30–60

secondsisequivalenttomakingnoentry.

Document Conventions

Thesedocumentconventionsareused:

Network channel 5 Network channel 10

Ten FlexTEMP System

Jackets per box

Symbol Symbol

xii

•Allproceduresarenumberedandanysub‐stepsarelettered.Completethestepsinthe

sequencepresentedtoensuresuccess.Proceduresareindicatedbythefollowingtable:

•Unlessnoted,allproceduresstartfromthenormalmodeofoperation.

• SelectmeanstopressonanactiveelementonthetouchscreenLCD(menuorsub‐menu

item,button,key,vitalsignbox,etcetera).

•Bulletedlistsindicategeneralinformationaboutaparticularfeature,menufunctionor

procedure,anddonotimplysequentialorderoroperation.

•Controlnames,menuitems,vitalsignreferences,messages,etcetera,arespelledasthey

appearontheExpressionMR400MRIPatientMonitoringSystem.

•Menuitems,keynamesandmessagesareprovidedinboldfont.

•The“greaterthan”(>)symbolisusedwhennavigationofitemswithinamenuisindicated.

•ThefrontoftheExpressionMR400MRIPatientMonitoringSystemisnearestyouasyou

operateit;theleftandrightsidesarerespectivelytoyourleftandrightasyoustandin

frontofthesystem,facingit.

•Thefrontofawirelessmoduleisnearestyouasyouoperateit.Thetopofthedevice

pointsuporawaywhenthelabelingnearestyouduringoperationiscorrectlyorientedfor

reading,whiletheleftandrightsidesofthedevicearerespectivelytoyourleftandrightas

youholdthedeviceforoperation,facingit.

Step Action

Contents

Contents 1

Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-ii

Identification and Publication Details. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-ii

Regulatory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-iii

Explanation of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-iii

Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-xi

System Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-xi

Document Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-xi

Chapter 1: Important Information

About . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Contra-indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Equipment Classification (According to IEC 60601-1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7

Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Radios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8

Using Batteries Safely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

Examining the Shipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13

Disposing of the Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14

Initial Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

Installing and Connecting Cart Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16

Attaching the SpO2 Probe to the wSpO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18

Rear Panel Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19

Connecting AC Mains Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20

Understanding Battery Operations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21

Cart Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21

Charging Cart Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21

Removing Cart Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22

Wireless Module Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-23

Charging Module Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24

Installing Batteries in the wECG Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24

Removing Batteries from the wECG Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-25

Installing a Battery in the wSpO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-26

Removing the Battery from the wSpO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-27

Understanding Wireless Network Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27

Setting the Wireless Network Channel of the Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-27

Setting the Wireless Network Channel of the wECG and wSpO2 Modules . . . . . . . . . . . . . .1-29

Advanced User Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33

Expression Information Portal (Model IP5). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-33

Additional Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-33

Accessory List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-33

Chapter 2: System Overview

System Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1

2 Contents

System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Use Model. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Acquisition and Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Synchronization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Device Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Hardware Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Display Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Patient Connection Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

wECG and wSpO2 Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

wECG Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

wECG Module Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

wSpO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

wSpO2 Module Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Storing Modules and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

Displayed Information and Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

Information Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Soft Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Status Information Pane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16

Status Information Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18

Vital Sign Boxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19

No Data Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20

Other Data Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

Vital Sign Traces and System Message Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

Navigation and Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22

Specialized Control Buttons and Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22

Default Setting Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23

System Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23

Password Protection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23

Modes of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23

Normal Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23

Suspend Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24

Simulation Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24

Chapter 3: Getting Started

Defibrillator and Electrosurgical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Positioning the MR400. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Operating the MR400. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

System Power-up and Communications Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Cart Power-down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Wireless Module Power-down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Monitor Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6

Viewing the Displayed Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Default Setting Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

User Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Initial Alarm Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Selecting the Patient Type. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Setup Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Contents 3

Monitor Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14

Edit User Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15

Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18

Sound Adjust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-20

Set Time & Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-22

Sweep Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25

Resp Speed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25

Service(Bio-Med). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26

Revision Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-28

Simulation Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-29

Gas Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30

System Config . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30

ECG Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-32

NIBP Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-33

Backlight Brightness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-34

Service Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-35

Chapter 4: Alarms

Alarm Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Visual Alarm Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2

Alarm Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2

Flashing Numeric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

Alarm Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

Audible Alarm Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

Alarm Sound State Indication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

Initial Audible Alarm Setting Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5

Controlling the Alarm Audio and Light Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5

Audio Pause Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6

Audio Off Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6

Alarm Volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

Alarm Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

Managing Alarm Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

Showing or Hiding Current Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

Adjusting the Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

Alarm Limit Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

The Alarm Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

Advanced Alarm Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

Setting Alarm Limits Globally. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12

Setting Alarm Limits Individually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13

Restoring Alarm Limit Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16

Enabling Print on Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17

Alarms Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17

1-Touch High %. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18

1-Touch Low % . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19

Alarm Sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20

Alarm Light. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20

Default Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

Limits Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

Adjustable Alarm Limit Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-22

4 Contents

Alarm Limit Factory Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

Measurement Limits and Over / Under Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

Listing of Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

Patient and INOP Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

Technical (INOP) Alarms and Other Status Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31

ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31

SPO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32

CO2 / CO (RESP) / AGENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

P1 (or P2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35

TEMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36

NIBP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36

Other Status Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37

Chapter 5: Monitoring ECG

ECG Monitoring Considerations for the MR Environment . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

wECG Module and ECG Lead Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Quadtrode Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Work Flow for ECG Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Selecting the ECG Lead Cable and Quadtrode Electrode Type. . . . . . . . . . . . . . . . . . . . . . . 5-5

Identifying the Placement Site for the Quadtrode Electrode. . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Preparing the Quadtrode Electrode Site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

Attaching the ECG Lead Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Lead Fail Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Checking the ECG Signal Strength. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Selecting the Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Changing the Lead View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

Minimizing ECG Waveform Noise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18

Positioning the ECG Lead Cable and wECG Module for Scanning . . . . . . . . . . . . . . . . . . . 5-19

Selecting the Filter Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22

ECG Waveforms and VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22

Changing the Heart Rate Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24

ECG Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26

Trace A Lead . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27

Trace B Lead . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28

Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28

Gating Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29

HR Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29

HR Tone Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30

Filter Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

Extreme HR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32

Pediatric ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32

T-Wave Suppression . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33

Chapter 6: Monitoring SPO2

wSpO2 Module, SpO2 Probe and SpO2 Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Patient Preparation for SpO2 Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Selecting the Site and SpO2 Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Attaching the Clip or Grip to the SpO2 Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Contents 5

Applying the SpO2 Attachment to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3

Perfusion Index Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6

Positioning the wSpO2 Module for Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6

SPO2 Waveform and VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

Assessing Suspicious SPO2 Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-9

Changing the SPO2 Waveform Amplitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-10

Changing the SPO2 Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11

SPO2 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-12

Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-13

Averaging Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-14

Perfusion Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15

Gating Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15

Desat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15

Desat Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-16

HR Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-17

HR Tone Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-18

Chapter 7: Monitoring CO2 (LoFlo Option)

MR400 Preparation for CO2 Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Operation and Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Warm-Up Period. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2

Zero Reference Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2

Breath Rate Distortion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3

Patient Preparation for CO2 Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4

Selecting the CO2 Accessory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4

Connecting the Sampling Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4

Applying the Sampling Line to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6

CO2 Waveform and VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7

Changing the CO2 and CO2 (RESP) Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9

Changing the Unit of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-11

CO2 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-12

Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-13

Grids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14

Zero Cal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15

Chapter 8: Monitoring Invasive Blood Pressure

Indications and Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Adult and Pediatric Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1

Neonatal Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1

Patient Preparation for IBP Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Transducer Component, Connection, and Feature Locations . . . . . . . . . . . . . . . . . . . . . .8-2

MR 400 Preparation for IBP Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

Adult and Pediatric Patients: Expression MR IBP DPT Kit, A/P (REF 989803194631) . . . . . .8-4

I. Connecting the Reusable Cable to the MR400 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4

II. Kit Set Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5

III. Purging Air from the Monitoring Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6

IV. Zeroing, Leveling and Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-7

V. Connecting the Monitoring Kit to the Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-8

6 Contents

The IBP transducer must not be mounted to the patient, or patient burn may result. . . 8-8

VI. Fast Flushing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9

VII. Checking for Leaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9

VIII. In the MR Room . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9

Neonatal Patients: Expression MR IBP DPT Kit, I/N (REF 989803194641). . . . . . . . . . . . . 8-10

I. Connecting the Reusable Cable to the MR400. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10

II. Kit Set Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10

III. Purging Air from the Monitoring Line. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12

IV. Zeroing, Leveling and Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12

V. Connecting the Monitoring Kit to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14

VI. Checking for Leaks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15

VII. In the MR Room. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15

Zeroing the Pressure Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16

Systolic/Diastolic Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17

Mean Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18

Changing the P1 (or P2) Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19

Changing the P1 (or P2) Waveform Amplitude. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19

Changing the P1 (or P2) Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-20

Changing the Unit of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-22

P1 (and P2) Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-22

Zero Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-24

Set Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-24

Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-25

HR Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26

Grids. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26

Grids Size. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-27

Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-28

Chapter 9: Monitoring Agents and Gases (AGENT Option)

MR400 Preparation for AGENT Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Operation and Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Warm-Up Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Zero Reference Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Breath Rate Distortion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

CO2 Low Flow and Occlusion Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4

Selecting AGENT Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

AGENT Tubing Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

Pre-Use System Checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8

Applying the Sampling Line to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10

Water Trap Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13

AGENT and GAS VS Boxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14

Multiple (Mixed) Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15

AGENT VS Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16

GAS VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17

Changing the AGENT and GAS Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17

MAC Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-20

CO2 Waveform and VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22

Changing the CO2 and CO2 (RESP) Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23

Changing the Unit of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-26

Contents 7

CO2 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-27

Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-28

Grids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-29

Zero Cal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-30

Chapter 10: Monitoring RESP

Patient Preparation for RESP Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

Monitoring Respiration using CO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1

Monitoring Respiration using the Bellows. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1

Bellows Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

Respiration VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-3

Changing the CO2 (RESP) Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5

RESP Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-7

Apnea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-8

Apnea Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-8

Chapter 11: Monitoring Temperature

General Usage Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

Initial Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2

Connecting and Disconnecting the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-3

Temperature Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4

Making Surface Temperature Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-4

Making Body Temperature Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-5

Placing the Temperature Sensor in a Jacket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-5

Placing the Temperature Sensor at the Body Site. . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6

Post-Measurement Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

Accuracy Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-8

TEMP VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-8

Changing the TEMP Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-9

Changing the Unit of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-10

TEMP Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10

Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-11

Chapter 12: Monitoring NIBP

Patient Preparation for NIBP Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-2

Selecting the NIBP Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-3

Positioning the NIBP Cuff. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-5

Connecting the NIBP Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-5

Choosing the Measurement Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-6

Making Automatic Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-6

Making Manual Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-7

Initial Inflation Pressures and Reading Durations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-7

Stopping an NIBP Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-8

Suspend Mode during NIBP Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-8

NIBP VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-8

Systolic/Diastolic Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-8

8 Contents

Mean Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10

Changing the NIBP Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-11

Changing the Unit of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-11

Changing the NIBP Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-12

NIBP Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-14

Interval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15

Auto Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-16

Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17

Chapter 1:3 Trend Data and Printing

Trending Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1

Viewing Tabular Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1

Tabular Trends Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1

Trend Arrows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-4

Arrow Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-6

Data Interval. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7

Clear Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8

Print Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-9

Print All. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-9

Stop Print . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-9

Printing Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10

Printing Parameter-Specific Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10

Controlling Printer Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10

Printer Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11

Printer Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11

Trace 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13

Trace 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14

Trace Delay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15

Chapter 14: Maintenance and Troubleshooting

General Cleaning Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1

Removing all Power to the MR400 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-2

Restoring all Power to the MR400 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-4

Removing Power from the Wireless Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-4

Restoring Power to the Wireless Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-4

User Routine-Checks and Planned Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-4

Cleaning, Disinfection, and Damage Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-6

Cleaning, Disinfecting, and Inspecting the Accessories. . . . . . . . . . . . . . . . . . . . . . . . 14-7

Cleaning, Disinfecting, and Inspecting MR400 and Wireless Modules . . . . . . . . . . . . 14-9

Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-10

Testing Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-11

Testing a Dropped Wireless Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-12

Verification Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-13

Anesthetic Oxygen (O2) Sensor Depletion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-13

Replacing the O2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-13

Updating Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-15

Calibrating the Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-16

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-16

Contents 9

Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-16

Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-17

Passing the Product on to another User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-18

Packaging the MR400. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-18

Final Disposal of the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-21

Disposal of the MR400 and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-21

Fitting, Removing and Disposing of Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-22

Appendix A: Specifications

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Displayed Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6

ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7

Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-9

CO2 (Optional LoFlo) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10

Invasive Blood Pressure (Optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-13

AGENT (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-15

Bellows Respiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-23

Temperature (Optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-23

Non-Invasive Blood Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-24

Gating Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-28

Appendix B: Warranty

Warranty Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

Appendix C: Regulatory Information

European Union . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-1

Authorized Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

Australia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

Appendix D: Gating Feature

MR400 Preparation for Gating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1

Gating Connector Pin-outs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1

Using the Gating Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2

Using ECG Gating. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2

Using SPO2 Gating. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-4

Appendix E: Guidelines and References

Guidelines for the Prevention of Excessive Heating and Burns Associated with Magnetic

Resonance Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-1

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

10 Contents

ExpressionMR400InstructionsforUseImportantInformation1‐1

CHAPTER 1

Important Information

About

AbouttheExpressionMR400MRIPatientMonitoringSystemandthisInstructionsforUse

ThisInstructionsforUseisintendedtoassistusersinthesafeandeffectiveoperationofthe

ExpressionMR400MRIPatientMonitoringSystem.

Beforeattemptingtooperatetheproduct,youmustreadthisInstructionsforUse,notingand

strictlyobservingallWARNINGSandCAUTIONnotices.

PayspecialattentiontoalltheinformationgivenandproceduresdescribedintheSAFETY

section.

AWARNINGalertsyoutoapotentialseriousoutcome,adverseeventorsafetyhazard.Failureto

observeawarningmayresultindeathorseriousinjurytotheuserorpatient.

ACAUTIONalertsyoutowherespecialcareisnecessaryforthesafeandeffectiveuseofthe

product.Failuretoobserveacautionmayresultinminorormoderatepersonalinjuryordamage

totheproductorotherproperty,andpossiblyinaremoteriskofmoreseriousinjury,and/or

causeenvironmentalpollution.

ANotehighlightsanunusualpointasanaidtoauser.

ThisInstructionsforUsedescribesthemostextensiveconfigurationoftheproduct,withthe

maximumnumberofoptionsandaccessories.Noteveryfunctiondescribedmaybeavailableon

yourproduct.

Thisproductwillperforminconformitywiththedescriptioncontainedinthismanualand

accompanyinglabelingwhenoperated,maintainedandrepairedinaccordancewiththe

instructionsprovided.

Thisdevicemustbecheckedandcalibratedperiodically.Amalfunctioningdevicemustnotbe

used.Partsthatarebroken,missing,plainlyworn,distorted,orcontaminatedmustbereplaced

immediately.Referthedevicetoqualifiedservicepersonnelforrepairorreplacement.This

deviceoranyofitspartsmustnotberepairedotherthaninaccordancewithwritteninstructions

providedbythemanufacturer.ThedeviceshallnotbealteredwithoutwrittenapprovalofRoyal

Philips.Theuserhasthesoleresponsibilityforanymalfunctionwhichresultsfromimproperuse,

faultymaintenance,improperrepair,damageoralterationbyanyoneotherthanauthorized

servicepersonnel.

1‐2ImportantInformationExpressionMR400InstructionsforUse

Intended Use

ThisPhilipsproductisintendedtobeusedandoperatedonlyinaccordancewiththesafety

proceduresandoperatinginstructionsgiveninthisInstructionsforUseforthepurposesfor

whichitwasdesigned.Thepurposesforwhichtheproductisintendedisgivenbelow.However,

nothingstatedinthisInstructionsforUsereducesusers’responsibilitiesforsoundclinical

judgmentandbestclinicalprocedure.

TheExpressionMR400MRIPatientMonitoringSystemisintendedforusebyhealthcare

professionalstomonitorvitalsignsofpatientsundergoingMRIproceduresandtoprovidesignals

forthesynchronizationoftheMRIscanner.

Useandoperationofthisproductissubjecttothelawinthejurisdiction(s)inwhichtheproduct

isbeingused.Usersmustonlyinstall,useandoperatetheproductinsuchwaysasdonotconflict

withapplicablelaws,orregulations,whichhavetheforceoflaw.Usesoftheproductfor

purposesotherthanthoseintendedandexpresslystatedbythemanufacturer,aswellas

incorrectuseoroperation,mayrelievethemanufacturer(orhisagent)fromallorsome

responsibilityforresultantnon‐compliance,damageorinjury.

CAUTION

Federal law restricts this device to sale by or on the order of a physician.

Compatibility

Theproductdescribedinthismanualshouldnotbeusedincombinationwithotherproductsor

componentsunlesssuchotherproductsorcomponentsareexpresslyrecognizedascompatible

byPhilipsMedicalSystems.[Alistofsuchproductsandcomponentsisavailablefromthe

manufacturer].Changesand/oradditionstotheproductshouldonlybecarriedoutbyPhilips

MedicalSystemsorbythirdpartiesexpresslyauthorizedbyPhilipsMedicalSystemstodoso.

Suchchangesand/oradditionsmustcomplywithallapplicablelawsandregulationsthathave

theforceoflawwithinthejurisdiction(s)concerned,andwithbestengineeringpractice.

Warning

WARNING

Changes and/or additions to the product that are carried out by persons without the

appropriate training and/or using unapproved spare parts may lead to the PMS warranty

being voided. As with all complex technical products, maintenance by persons not

appropriately qualified and/or using unapproved spare parts carries serious risks of damage

to the product and of personal injury.

Indications for Use

TheExpressionMR400MRIPatientMonitoringSystemisintendedforusebyhealthcare

professionalstomonitorvitalsignsofpatientsundergoingMRIproceduresandtoprovidesignals

forsynchronizationfortheMRIscanner(alsoreferredtoas“triggering”or“gating”). The

ExpressionMR400providesmonitoringforthefollowingvitalsignsandparameters:

electrocardiogram(ECG),pulseoximetry(SpO2),non‐invasivebloodpressure(NIBP);and

optionally,invasivebloodpressure(IBP),carbondioxide(CO2)andrespirationrate,anesthetic

agents,oxygen(O2),nitrousoxide(N2O),andtemperature.

Notes

• The MR400 is intended to be used to monitor the vital signs of a patient in an MR magnet

room. Monitoring outside the magnet room (e.g., the MR induction and/or MR recovery

areas) is acceptable for the short duration of time in which the patient is being prepared for

the MR scan and during the recovery period within the MR. This system is not intended for

use on a patient being transported outside of a health care facility.

• The MR400 is intended for use on patients receiving MR scans, which may include

neonatal, pediatric, or adult patients. If determined by a qualified healthcare provider, this

may also include pregnant patients.

• The bellows-derived respiration rate measurement is not intended for vital sign monitoring.

Contra-indications

ThisPhilipsproductshouldnotbeusedifanyofthefollowingcontra‐indicationsexistorare

thoughttoexist.Thisdeviceiscontra‐indicatedforpatientswithmetallicwires,implants,stents,

etcetera.Screenallpatientsformetallicwires,implants,stents,etceterapriortoMR

procedures.TheseelectricalconductorswillreactwiththeMRenvironmentorwiththe

accessory(ifapplieddirectlyovertheconductor),thusincreasingtheriskofheating.The

warningsbelowrefertotheExpressionMR400MRIPatientMonitoringSysteminitsentirety.

WARNINGS

•The Expression MR400 MRI Patient Monitoring System is not intended for use with

patients using pacemakers or electrical stimulators.

•Do not use if MR workers are present who have metallic wires, implants, stents, et

cetera. Screen all MR workers for metallic wires, implants, stents, et cetera, prior to

MR procedures when using the Expression MR400 MRI Patient Monitoring System in

the MR magnet room.

• Do not use on patients with metallic wires, implants, stents, et cetera. Screen all

patients for metallic wires, implants, stents, et cetera, prior to MR procedures. These

electrical conductors will react with the MR environment or with the accessory (if

applied directly over the conductor), thus increasing the risk of heating.

1‐4ImportantInformationExpressionMR400InstructionsforUse

Training

Usersofthisproductmusthavereceivedadequatetrainingonitssafeandeffectiveusebefore

attemptingtooperatetheproductdescribedinthisInstructionsforUse.Trainingrequirements

forthistypeofdevicewillvaryfromcountrytocountry.Usersmustmakesuretheyreceive

adequatetraininginaccordancewithlocallawsorregulations.Ifyourequirefurtherinformation

abouttrainingintheuseofthisproduct,pleasecontactyourlocalPhilipsMedicalSystems

representative.Alternatively,contactthemanufacturer.

ADEQUATETRAINING

WARNINGS

•Do not use the product for any application until you have received adequate and

proper training in its safe and effective operation. If you are unsure of your ability to

operate this product safely and effectively DO NOT USE IT. Operation of this product

without proper and adequate training could lead to fatal or other serious personal

injury. It could also lead to clinical mis-diagnosis or to clinical mistreatment.

• Do not operate the product with patients unless you have an adequate understanding

of its capabilities and functions. Using this product without such an understanding

may compromise its effectiveness and/or reduce the safety of the patient, you and

others.

Safety

BeforeusingtheExpressionMR400MRIPatientMonitoringSystem,readthesafetyinformation

below.ThewarningsbelowrefertotheExpressionMR400MRIPatientMonitoringSysteminits

entirety.

MAINTENANCE&FAULTS

Warning

WARNING

Do not use the product for any application until you are sure that the user routine-checks

have been satisfactorily completed, and that the periodic maintenance of the product is up to

date. If any part of the product is known (or suspected) to be defective or wrongly adjusted,

DO NOT USE the product until a repair has been made. Operation of the product with

defective or wrongly adjusted components could expose the user or the patient to safety

hazards. This could lead to fatal or other serious personal injury, or to clinical misdiagnosis,

or to clinical mistreatment.

SAFETYAWARENESS

Warning

WARNING

Do not use the product for any application until you have read, understood and know all the

safety information, safety procedures and emergency procedures contained in this SAFETY

section. Operation of the product without a proper awareness of how to use it safely could

lead to fatal or other serious personal injury. It could also lead to clinical misdiagnosis or to

clinical mistreatment.

SAFETYDEVICES

Warning

WARNING

Never attempt to remove, modify, or over-ride or frustrate any safety device on the product.

Interfering with safety devices could lead to fatal or other serious personal injury.

INTENDEDUSEANDCOMPATIBILITY

Warning

WARNING

Do not use the product for any purpose other than those for which it is intended. Do not use

the product with any product other than that which Philips Medical Systems recognizes as

compatible. Operation of the product for unintended purposes, or with incompatible

product, could lead to fatal or other serious injury. It could also lead to clinical misdiagnosis

or to clinical mistreatment.

ELECTRICALSAFETY

Warning

WARNING

Do not remove covers or cables from this product (unless expressly instructed to do so in this

Instructions for Use). Dangerous electrical voltages are present within this product.

Removing covers or cables could lead to serious or fatal personal injury.

Covers or cables should [normally] only be removed by qualified and authorized service

personnel. Use this product in rooms or areas that comply with all applicable law (or regulations

having the force of law) concerning electrical safety for this type of product.

Electrically isolate this product from the mains electrical supply before cleaning or disinfecting.

Equipotential ground connection: An equipotential ground (earth) connection point is provided.

Use this product in areas meeting local standards for electrical safety in rooms used for medical

purposes, for example the US National Electrical Code. IEC 60601 also gives guidance about an

equipotential ground (earth) connection point.

Additional equipotential ground connection: An additional equipotential ground (earth) connection

point is provided, because the product is transportable and the reliability of the main equipotential

ground connection point might be insufficient.

1‐6ImportantInformationExpressionMR400InstructionsforUse

MECHANICALSAFETY

Warning

WARNING

Do not remove covers from this product unless expressly instructed to do so in this

Instructions for Use. Moving parts are present within this product. Removing covers could

lead to serious or fatal personal injury.

Covers should normally only be removed by qualified and authorized service personnel. In this

context, qualified means those legally permitted to work on this type of medical electrical product

in the jurisdiction(s) in which the product is being used, and authorized means those authorized by

the user of the product.

FIRESAFETY

Useofanelectricalproductinanenvironmentforwhichitwasnotdesignedcanleadtofireor

explosion.Fireregulationsforthetypeofmedicalareabeingusedshouldbefullyapplied,

observedandenforced.Fireextinguishersshouldbeavailableforbothelectricalandnon‐

electricalfires.

Warning

WARNING

Only use extinguishers on electrical or chemical fires, which are specifically labeled for those

purposes. Using water or other liquids on an electrical fire can lead to fatal or other serious

personal injury.

Ifitissafetodoso,attempttoisolatetheproductfromelectricalandothersuppliesbefore

attemptingtofightafire.Thiswillreducetheriskofelectricshocks.

ELECTROSTATICDISCHARGE

Electrostaticdischarge(ESD)canamounttoasignificantvoltage,whichmaycausedamageto

PCBsorothersystemcomponents.

Caution

CAUTIONS

• Always wait at least ten seconds after the product is switched OFF before switching the

product back to ON.

• Always use proper static procedures, protection, and product prior to opening and during

handling of this product. This product contains components that are electrostatic sensitive.

Failure to use ESD procedures may cause damage to these components. Such damage to

components is not covered by Philips warranties.

ConnectionstosensitivepartsareidentifiedbytheESDwarningsymbol(see

inset).ESDdamageiscumulativeandmaynotbeapparentatfirst,asindicated

byahardfailure,butcancausedegradedperformance.Therefore,alwaysuse

properESDhandlingprocedures.ESDcanresultfromlowhumidityconditions,

useofelectricalequipmentoncarpeting,linens,andclothing.

ELECTROMAGNETICCOMPATIBILITY(EMC)

ThisPhilipsproductcomplieswithrelevantinternationalandnationallawandstandardsonEMC

(electromagneticcompatibility)forthistypeofproductwhenusedasintended.Suchlawsand

standardsdefineboththepermissibleelectromagneticemissionlevelsfromproductandits

requiredimmunitytoelectromagneticinterferencefromexternalsources.

OtherelectronicproductsexceedingthelimitsdefinedinsuchEMCstandardscould,under

unusualcircumstances,affecttheoperationoftheproduct.

•MedicalelectricalproductsneedsspecialprecautionsregardingEMC,andneedstobe

installedandputintoserviceaccordingtoEMCinformationprovidedinthisInstructionsfor

Use.

•Theuseofaccessoriesandcablesotherthanthosespecified,mayresultinincreased

emissionordecreasedimmunitylevels.

•Theproductshouldnotbeusedadjacenttoorstackedwithotherproductsandthatif

adjacentorstackeduseisnecessary,itshouldbeobservedtoverifynormaloperation.

CAUTION

Portable and Mobile Phones

Portable and mobile RF communications can affect medical electrical equipment. Use caution

when using such communication devices within the specified range of medical electrical devices.

The Expression MR400 MRI Patient Monitoring System may be interfered with by other

equipment with CISPR emission requirements.

Equipment Classification (According to IEC 60601-1)

According to the type of protection against

electrical shock: Class I equipment

According to the degree of protection against

electrical shock: Type CF (defibrillator-proof) equipment

According to the degree of ingress protection: Rated IP21: Protected against access to

hazardous parts and the ingress of solid

foreign objects greater than 12.5mm (0.5

inch); and, protected against vertically

dripping liquid.

According to the methods of sterilization or

disinfection:

Non-sterilizable; use of liquid surface

disinfectants only

According to the mode of operation: Continuous operation

Equipment not suitable for use in the presence of flammable anesthetic mixture with air,

oxygen or nitrous oxide.

1‐8ImportantInformationExpressionMR400InstructionsforUse

Electromagnetic Compatibility (EMC)

Thedeviceisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Giventhe

device’selectromagneticemissionsandimmunitycharacteristics,thecustomerorusershould

assurethatthedeviceisusedwithinsuchanenvironment.Thefollowinginformationis

mandatedbyIEC60601‐1‐2,theinternationalstandardfortheelectromagneticcompatibility

(EMC)ofmedicalelectricalequipment.

Radios

INDUSTRYCANADASTATEMENT

ThisdevicecomplieswithIndustryCanadalicense‐exemptRSSstandard(s).Operationissubjectto

thefollowingtwoconditions:(1)thisdevicemaynotcauseinterference,and(2)thisdevicemust

acceptanyinterference,includinginterferencethatmaycauseundesiredoperationofthedevice.

LeprésentappareilestconformeauxCNRd'IndustrieCanadaapplicablesauxappareilsradio

exemptsdelicence.L'exploitationestautoriséeauxdeuxconditionssuivantes:(1)l'appareilne

doitpasproduiredebrouillage,et(2)l'utilisateurdel'appareildoitacceptertoutbrouillage

radioélectriquesubi,mêmesilebrouillageestsusceptibled'encompromettrelefonctionnement.

FCCCOMPLIANCESTATEMENT

CAUTION

Changes or modifications not expressly approved could void your authority to use this equipment

Thisdevicecomplieswithpart15oftheFCCRules.Operationissubjecttothefollowingtwo

conditions:(1)Thisdevicemaynotcauseharmfulinterference,and(2)thisdevicemustaccept

anyinterferencereceived,includinginterferencethatmaycauseundesiredoperation.

FrequencyRange:2402–2482MHz

ModulationType:GFSK

WPUEIRP:4.2dBm(peak)

wECGandwSpO2EIRP:0dBm(peak)

Warning

WARNING

The use of accessories, transducers and cables other than those specified in the accessory list

accompanying this Instructions for Use (with the exception of transducers and cables sold by

Invivo (Royal Philips) for the equipment or system as replacement parts for internal

components) will result in increased emissions or decreased immunity of the equipment or

system.

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

The Expression MR400 MRI Patient Monitoring System is intended for use in the electromagnetic environment

specified below, and the customer or the user should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

RF Emissions, CISPR 11 Group 1 The Expression MR400 MRI Patient Monitoring System uses RF

energy only for its internal functions. Therefore, its RF emissions

are very low and are not likely to cause any interference in

nearby electronic equipment.

RF Emissions, CISPR 11 Class B The Expression MR400 MRI Patient Monitoring System is

suitable for use in all establishments, other than domestic

establishments and those directly connected to the public low-

voltage power supply network that supplies buildings used for

domestic purposes.

Harmonic Emissions, IEC

61000-3-2

Class B

Voltage Fluctuations / Flicker

Emissions, IEC 61000-3-3

Complies

1‐10ImportantInformationExpressionMR400InstructionsforUse

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The Expression MR400 MRI Patient Monitoring System is intended for use in the electromagnetic environment

specified below. The customer or the user of the Expression MR400 MRI Patient Monitoring System should assure

that it is used in such an environment.

Immunity

Test IEC 60601 Test Level Compliance Level Electromagnetic

Environment - Guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

± 6kV contact

± 8kV air

± 6kV contact

± 8kV air

Floors should be wood,

concrete or ceramic tile. If

floors are covered with

synthetic material, the

relative humidity should be at

least 30%.

Electrical fast

transient/burst

IEC 61000-4-4

± 2kV for power supply lines

± 1kV for input/output lines

± 2kV for power supply lines

± 1kV for input/output lines

Mains power quality should

be that of a typical

commercial or hospital

environment.

Surge

IEC 61000-4-5

± 1kV differential mode

± 2kV common mode

± 1kV differential mode

± 2kV common mode

Mains power quality should

be that of a typical

commercial or hospital

environment.

Voltage dips,

short

interruptions

and voltage

variations on

power supply

input lines

IEC 61000-4-11

< 5% Ut

(> 95% dip in Ut) for 0.5 cycle

40% Ut

(60% dip in Ut) for 5 cycles

70% Ut

(30% dip in Ut) for 25 cycles

< 5% Ut

(> 95% dip in Ut) for 5

seconds

< 5% Ut

(> 95% dip in Ut) for 0.5 cycle

40% Ut

(60% dip in Ut) for 5 cycles

70% Ut

(30% dip in Ut) for 25 cycles

< 5% Ut

(> 95% dip in Ut) for 5 seconds

Mains power quality should

be that of a typical

commercial or hospital

environment. If the user of

the Expression MR400 MRI

Patient Monitoring System

requires continued operation

during AC power

interruptions, power from an

uninterruptible power supply

or battery is recommended.

Power

frequency (50/

60 Hz)

magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic

fields should be at levels

characteristic of a typical

location in a typical

commercial or hospital

environment.

Note

Ut is the AC mains voltage prior to application of the test level.

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The Expression MR400 MRI Patient Monitoring System is intended for use in the electromagnetic environment

specified below. The customer or the user of the Expression MR400 MRI Patient Monitoring System should assure that

it is used in such an environment.

Immunity Test IEC 60601 Test

Level

Compliance

Level Electromagnetic Environment - Guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 KHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

V1 = 3 Vrms

E1 = 3 V/m

Portable and mobile RF communications equipment

should not be used no closer to any part of the

Expression MR400 MRI Patient Monitoring System,

including cables, than the recommended separation

distance calculated from the equation applicable to

the frequency of the transmitter.

Recommended separation distance

d = (3.5/V1)

d = (3.5/E1)

(80 MHz to 800 MHz)

d = (7/E1)

(800 MHz to 2.5 GHz)

Where P is the maximum output power rating of

the transmitter in watts (W) according to the

transmitter manufacturer and d is the recom-

mended separation distance in meters (m).

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey,a

should be less than the compliance level in each

frequency range.b

Interference may occur in the vicinity of equipment

marked with the symbol.

• At 80 MHz and 800 MHz, the higher frequency range applies.

• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,

amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the

electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured

field strength in the location in which the Expression MR400 MRI Patient Monitoring System is used exceeds the applicable RF

compliance level above, the Expression MR400 MRI Patient Monitoring System should be observed to ensure normal operation. If

abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Expression MR400

MRI Patient Monitoring System.

b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.

1‐12ImportantInformationExpressionMR400InstructionsforUse

Using Batteries Safely

Batterieshavelifecycles.Thebatterylifeisatanendwhentheequipmentoperatingtime

providedbybatterypowerbecomesmuchshorterthanusual(i.e.,whenthetotalbattery

capacityhasonly70percentitsinitialcapacity).Foroptimalbatterylife,pleasefollowthese

guidelines:

•Donotstorethebatteriesinadischargedcondition.Alwayschargeabatterytoatleast40

percentofcapacitybeforestoring.

•Chargethebatteriesonceamonthwhennotinuse.

Immediatelyremoveanybatterythathasanexpiredlifecycleandreplaceitwithanewbattery

ofthesametype.(Refertopage1‐37forpartnumbers.)Toensurethesafetyofoperatorsand

patients,observethefollowingwarningsandcautions.

Recommended Separation Distances between Portable and Mobile RF Communications Equipment

and the Expression MR400 MRI Patient Monitoring System

The Expression MR400 MRI Patient Monitoring System is intended for use in an electromagnetic environment in

which radiated RF disturbances are controlled. The customer or the user of the Expression MR400 MRI Patient

Monitoring System can help prevent electromagnetic interference by maintaining a minimum distance between

portable and mobile RF communications equipment (transmitters) and the Expression MR400 MRI Patient Monitoring

System as recommended below, according to the maximum output power of the communications equipment.

Rated Maximum Output

Power Of Transmitter

(W)

Separation Distance According To Frequency Of Transmitter (m)

150 KHz to 80 MHz

d = (3.5/V1)

80 MHz to 800 MHz

d = (3.5/E1)

800 MHz to 2.5 GHz

d = (7/E1)

0.01 0.117 0.117 0.233

0.1 0.369 0.369 0.738

1 1.167 1.167 2.333

10 3.689 3.689 7.379

100 11.667 11.667 23.333

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in

meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the

maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects and people.

Warning

WARNING

Do not use a damaged battery. Periodically check batteries, stop using and replace any

battery that exhibits abnormal heat, odor, color, deformation, or other condition. If a battery

is punctured or if battery liquid leaks onto your skin or clothing, immediately wash the area

and clothing with fresh water. If battery liquid gets into your eyes, do not rub your eyes;

immediately flush your eyes with clean water and consult a physician.

Caution

CAUTIONS

• If the battery contacts become dirty, wipe them clean with a dry cloth before use. Do not

immerse in a battery in water or other liquids.

• Store batteries in a dry place, between 0 to 40°C (32 to 104°F) . Do not expose a battery to

temperatures above 60°C (140°F).

• Do not short the external battery contacts. Keep metal objects away from the battery

contacts.

• Store each battery in a manner that prevents shorting with the container or another cell/

battery.

• Only use the Philips specified charger.

Examining the Shipment

Toreportshippingdamage,ortoresolveanyissuesorconcernswithyourorder,contact

CustomerService.(Saveallpackingmaterialsandrelatedshippingdocuments,asthesemaybe

requiredtoprocessashippingdamageclaimwiththecarrier.)

Afterremovingthecontentsfromtheshippingcontainers,carefullyexamineallitemsforsignsof

damagethatmayhaveoccurredduringshipment.Also,checkallitemsagainsttheincluded

packinglistandthepurchaserequest.

Thecontentsofthecrateshouldinclude:

• ExpressionMR400MRIPatientMonitoringSystem

•Twomainbatteries

•InstructionsforUse(IFU)manual

•QuickReferenceGuide(includedinEnglish‐localizedshipmentsonly)

•PowerCord

Aseparatecontainermayincludeadditionalitems:

• WirelessECGpatientmodule(Gen3)

• WirelessSpO2patientmodule(Gen3)

1‐14ImportantInformationExpressionMR400InstructionsforUse

•Modulebatterycharger

•Modulebatteries

Disposing of the Packaging

Thepackagingcanberetainedforfutureuse.Otherwise,thepackagingforthesystem(whichis

madeofrecyclablematerialsthatincludecorrugatedpaper,polyethylene[PE]foamandplastic)

maybesubjecttodisposalregulationsforuserandenvironmentalsafety.Fordisposal,itmaybe

necessarytoseparatethesematerialsbytype.Alwaysobserveandadheretoyourcurrentlocal

regulationswhendisposingofthepackagingmaterial.

Initial Setup

Theinstructionsbelowdetailtheinitialsetupprocessforafully‐equippedExpressionMR400MRI

PatientMonitoringSystem(hereafterreferredtoastheMR400)—includingthewirelessECG

patientmodule(hereafterreferredtoasthewECGmodule)andthewirelessSpO2patient

module(hereafterreferredtoasthewSpO2module)andhereafterreferredtocollectivelyas

wirelessmodules.

DependingupontheneedsofyourfacilityandtheMR400optionspurchased,thestepsyou

followmaydifferandsomemaynotberequired.Forthelocationofcomponentsnotdetailed

below,seechapter2.

WARNINGS

• Only perform initial setup of the MR400 at a location outside of the MR magnet room.

Failure to observe this warning may result in serious injury.

• No modification of this equipment is allowed. Failure to observe this warning may

result in serious injury.

CAUTION

The MR400 and accessories must be used and stored according to the environmental

specifications detailed in Appendix A. Failure to adhere to the specified environmental

requirements may affect system and/or accessory performance and accuracy.

ToperforminitialsetupoftheMR400

Step Action

1PerformavisualinspectionoftheMR400,checkingforlooseor

missinghardwareordamage.

Iflooseormissinghardwareordamageisobserved,contact

technicalsupport.

2Installthemainbatteriesintothecartandconnectthereserve

batteries;seepage1‐16.

3ConnectACmainspowertotheMR400,butDONOTturnonthe

powerswitch.Allowthebatteriestochargeforatleast12hours

beforeuse;seepage1‐20.

Note

Before initial use, charge the batteries in the cart for at least 12

hours with the MR400 turned off and connected to AC mains power.

4IfwECGandwSpO2moduleswereincluded,performavisual

inspectionofthedevicesforlooseormissinghardwareordamage.

5IfawSpO2modulewasincluded,attachanSPO2probetoit;see

page1‐18.

6Ifmodulebatterieswereincluded,chargethemodulebatteries

usingthePhilips‐specifiedbatterycharger.(Refertothe

instructionsprovidedwiththecharger.)

Note

Before initial use, charge the module batteries for at least 4 hours.

7Pressthepowerswitch(onthefrontofthecart)thenverifythatthe

MR400hassuccessfullypowered‐upandthatthepowerLEDis

steadygreen.

Forotherpossibleindications,seepage2‐7.

8IfequippedwithanIP5,verifythattheMR400andIP5aresettothe

samewirelessnetworkchannelbycheckingthenetworkicon(see

examplesbelow)thatisdisplayedbyeachdevice.

Seepage1‐27forMR400networksettinginstructions;and,referto

theIFUfortheIP5fornetworksettinginstructions.

9IfwECGandwSpO2moduleswereincluded,installthecharged

modulebattery(orbatteries)intothedevice(s);seepage1‐24for

thewECGmoduleandseepage1‐26forwSpO2module.

1‐16ImportantInformationExpressionMR400InstructionsforUse

Installing and Connecting Cart Batteries

Warning

WARNING

Cart batteries contain ferrous materials that are attracted to the MR magnetic field. Do not

install or remove the cart batteries when closer than the 1,000 gauss (0.1 T) field line, as

measured from the center line of the MR bore to the MR400. The batteries will be attracted

to the magnetic field, possibly causing patient or user injury.

CAUTION

Never force a main battery into a battery compartment as it will damage the battery and/or the cart.

FourbatteriesareusedintheMR400:

•Twomainbatteriesmustbeinserted—oneintotheleftbatterycompartmentandoneinto

therightbatterycompartmentofthecart;and,

•Tworeservebatteries,internally‐housedinthecart,mustbeswitchedon.

Toinstallandconnectthemainandreservebatteries

10 VerifythatthestatusindicatoronthewECGandwSpO2modulesis

illuminatedsteadygreen:

•ForthewECGmodule,seepage2‐9.

•ForthewSpO2module,seepage2‐11.

11 VerifythatthewirelessnetworkchannelsonthewECGandwSpO2

modulesaresettothechannelusedbytheMR400;seepage1‐29.

12 PlacethewECGandwSpO2modulesintothemoduleholderson

theMR400;seepage2‐12.

Thiscompletestheinitialsetupprocess.Forinformationregarding

otherpossibleMR400connections;seeRearPanelConnectionson

page1‐19.

Step Action

1Locatethebatterycompartments,whichareunderneaththeWPU

ontheleftandrightsidesofthecart.

2Holdamaincartbatterywiththelabelsidedownandwithits

connectorfacingforward.(Silkscreeningaboveeachbattery

compartmentprovidesthecorrectbatteryorientation—theleft

sideisshownintheexamplebelow.)Then,slidethebattery

completelyintothebatterycompartmentuntila“click”isheardas

thebatterylatchesintoplace.

(Ifthebatterydoesnotlatchintoplacewheninserted,thenitis

notproperlyoriented.Inthiscase,remove,reorientcorrectly,and

thenreinsertthebattery.)

3Repeatsteps1and2toinstalltheremainingmaincartbatteryon

theoppositesideofthecart.

4 Removetheshieldcapfromthegatingconnectorandthetwo

screwsthatsecuretheservicepanelcovertothebackoftheWPU

thenremovetheservicepanelcover.

Step Action

Main cart battery

Battery compartment

WPU

Screws

Service panel

cover

Shield cap

1‐18ImportantInformationExpressionMR400InstructionsforUse

Attaching the SpO2 Probe to the wSpO2 Module

TheSpO2probe,necessaryfortakingSpO2‐relatedmeasurementsusingthewSpO2module,

mustbeconnectedprioruse.

WARNINGS

• Only perform this attachment at a location outside of the MR magnet room. Failure to

observe this warning may result in serious injury.

• Connecting an other than specified SPO2 probe to the wSpO2 module can cause

inaccurate SPO2 readings and damage the module.

ToattachtheSPO2probe

InserttheSPO2probeconnectorintotheDB‐9connectoronthewSpO2

modulethensecurelytightenbothscrews.

5LocatethebatteryswitchandtoggleitintotheOn(I)position.

6 Reinstalltheservicepanelcover,andsecureittotheWPUusing

thetwoscrews.

7Replacetheshieldcap.

Thiscompletestheinstallationandconnectionofthemainand

reservebatteries.ConnectACmainspowerthenallowthese

batteriestochargeforatleast12hoursbeforeinitialuse;seepage

1‐21.

Step Action

Battery switch

1wSpO2 module

2DB-9 connector

3SPO2 probe connector

4Screws

Rear Panel Connections

DependingupontheoptionsincludedwithyourMR400ortheusemodel,someconnectionsmay

berequiredaftermovingtheMR400intotheMRmagnetroom.Inadditiontotheconnectionfor

ACmainspower,connectionsforthewastegasportandthegatingcableareavailableonthe

rearpaneloftheMR400.(ForinformationabouttheplacementoftheMR400intheMRmagnet

room,seepage3‐2.)

CAUTION

When making connections to the rear panel of the MR400, ensure that the final installation

complies with IEC 60601-1, clause 16, Medical Electrical (ME) Systems, to assure operator and

patient safety. Always check the summation of leakage currents when the MR400 is connected to

additional external equipment.

Wheretheintegrityoftheexternalprotectiveconductorintheinstallationoritsarrangementis

indoubt,theMR400shallbeoperatedfrombatteries.



1 Gating connector for gating control connections to the MR

system. (Gating cables are type-dependent; see page 1-35.)

2Waste gas port (if equipped) for connection of exhausted sam-

pled respiratory gases from the MR400 to your facility’s gas scaveng-

ing system; suggested tubing requirement: 3.175 mm (0.125 inch)

outer diameter, 1.6 mm (0.063 inch) inner diameter.

3 Ground lug (equipotential ground [earth] connection point)

• allows for electrical safety testing; and,

• allows authorized service personnel to connect a ground

strap for prevention of ESD during servicing.

1‐20ImportantInformationExpressionMR400InstructionsforUse

Connecting AC Mains Power

WhenconnectingtheMR400tothemainselectricalsupply,donotroutethedetachablepower

cordwhereitwillbeanobstructionorsteppedupon.DonotblockaccesstotheMR400with

otherequipmentandneverpositiontheMR400insuchawaythatwouldmakeitdifficultto

unplug.

WARNINGS

• Only use the supplied power cord and connect to properly grounded AC outlets to

avoid electrical shock.

• Avoid use of electrical extension cords or multiple portable socket outlets, which may

create a safety hazard by compromising the grounding integrity of the MR400.

ToconnectACmainspower

ToremovetheMR400fromACmainspower

PulltheplugofpowercordfromtheACwalloutlet.Then,liftthestrainreliefandremovethe

powercordfromtheACreceptacleontherearoftheMR400.Storethecordinasafeplace.

4Strain relief for retention of the power cord.

5AC receptacle for connection of the power cord.

Step Action

1Ensurethatallcartbatteriesareinstalledandswitchedon;see

page1‐16fordetails.

2IfplacingtheMR400intheMRmagnetroom,positiontheMR400

ataproperlocation;seepage3‐2.

3Raisethestrainrelief;seepage1‐20forthelocation.

4PlugthepowercordintotheACreceptacleontheMR400;see

page1‐20forthelocation.

Foraddedmobility,thepowercordextension(REF989803168221)

canalsobeconnected.

5Lowerthestrainreliefoverthepowercord.

6PlugthepowercordintoanapprovedACmainsoutlet.

Understanding Battery Operations

Cart Batteries

Warning

WARNING

Do not touch the patient and the circuitry in the battery compartments of the MR400

simultaneously.

Cartbatteries,wheninstalled(main)andswitchedon(reserve),arechargedandconditionedby

anintegratedchargingsystem.WhenturnedonandconnectedtoACmains,theMR400operates

fromACpowerandsimultaneouslychargesallcartbatteries.Whenturnedoffandconnectedto

ACmains,batterychargingfunctionscontinue.

Ifatanytime,ACmainsislost,theMR400willautomaticallyswitchtobatterypowertoprovide

uninterruptedservice—then,whenACmainsisrestored,theMR400willautomatically,without

delay,revertbacktoACpowerfunctions.IfthereservebatteriesarefullydepletedandACmains

islost,thentheunitwillpoweroff.

TheMR400’smaximumoperatingtimeonbatterypowerdependsupontheenabledparameters

andthetypeandfrequencyofmonitoringfunctions(seetheBattery,OperationTimeonpageA‐4

foralisting).

Charging Cart Batteries

Cartbatteriesmustbechargedbeforeinitialuse.Duringinitialsetuporwheninstallingnew

batteries,chargethecartbatteriesforatleast12hourssothattheyarefullychargedand

conditionedforoperation.

Notes

• Use only with the specified battery charger.

• The main batteries must always be inserted and the reserve batteries must always be

switched on to prevent loss of patient monitoring during a power outage. If main batteries

are not inserted and if the reserve batteries are not switched on, then during power outage

unsaved user settings will revert to factory defaults.

• We recommend plugging the MR400 into a backup generator or equivalent means to

prevent a lapse in patient monitoring during a power loss.

1‐22ImportantInformationExpressionMR400InstructionsforUse

Tochargethecartbatteries

Chargedcapacityofallcartbatteriescanbedisplayed;seetheStatusInformationPanelonpage

2‐18).

Chargedcapacitycanalsobefoundbypressingthepowerlevel

buttononeachmaincartbattery,wherethecurrentlevelis

providedbythechargeindicator;seeRemovingCartBatteries,

below.

Removing Cart Batteries

Toremovethemainbatteries

Step Action

1Ensurethatallcartbatteriesareinstalledandswitchedon.

SeeInstallingandConnectingCartBatteriesonpage1‐16for

details.

2ConnecttheMR400toACmainspower.

SeeConnectingACMainsPoweronpage1‐20.

3EnsurethattheMR400isturnedoffandthatitremainsoffforthe

next12hours.

1Charge indicator

2Power level button

3Cart battery

Step Action

1Locatethebatteryejectbutton,whichisinarecessedareaunder

eachbatterycompartmentontheleftandrightsidesofthecart.

Note

The reserve batteries cannot be removed, but can be switched off. For instructions on the complete

removal of power to the MR400, see page 14-2.

Wireless Module Batteries

ModulebatteriesprovidepowertothewECGandwSpO2modules.Modulebatteriesare

interchangeable,non‐magnetic,andcanbehandledsafelyintheMRmagnetroom.

CAUTION

To minimize the chance of image artifacts, never place module batteries in the MRI field of view.

2Pressthebatteryejectbuttontopartiallyejectamainbatteryfrom

thebatterycompartment,andthengraspthebatteryandpullto

removeitcompletelyfromtheMR400.

(Ifthebatterydoesnotrelease,applyaslightforwardpressureto

thebatterywhilepressingthebatteryejectbutton.)

3Repeatsteps1and2toremovetheothermaincartbatteryonthe

oppositesideoftheMR400.

Main battery

Battery compartment

Battery eject button

1‐24ImportantInformationExpressionMR400InstructionsforUse

Charging Module Batteries

Modulebatteriesmustbechargedforatleast4hoursbeforeinitialuse.Modulebatteriesare

chargedinthePhilips‐specifiedbatterycharger.Refertotheinstructionsprovidedwiththis

batterychargerforinformation.

Installing Batteries in the wECG Module

ThewECGmodulecanacceptuptotwobatteries.Dependinguponthenumberofbatteries

installed,thewECGmoduleprovidedifferentoperationalfeatures:

•Ifonebatteryisinstalled,thenthewECGmodulewillturnonandfunctionnormally—but

beforeitschargeisexhausted,asecondbatterymustbeinstalledinordertocontinuethe

ECGstudy.

•Iftwobatteriesareinstalled,thenseamlessoperationispossible—onebatterywillprovide

poweruntilitschargeisexhausted,atwhichtimethewECGmodulewillautomatically

switchtotheremainingbatteryforcontinuedoperation.Aslongassufficientpoweris

providedbythesecondbattery,continuedoperationispossible.And,anexhausted

batterycanbereplacedatanytimewithoutinterruptiontotheECGstudy,providedthat

sufficientchargeispresentontheremainingbattery.

•IndicatorsidentifythesourcebatterybeingusedbythewECGmodule;seepage2‐9.

•Whenbothbatteriesareremoved,thewECGmodulewillturnoff.

ToinstallbatteriesinthewECGmodule

Step Action

1HoldthewECGmodulesothatitsbatterybaysareorientedas

shown,withbatterybay1inthelowerpositionandbatterybay2

intheupperposition.



wECG module

Bay 1

Bay 2

Removing Batteries from the wECG Module

Toremovebattery1fromthewECGmodule

Pressabatteryejectbutton1(item1,right).Then

graspthepartiallyejectedmodulebattery(item2)

andpulltoremoveit.

2Orientamodulebatterysothatthetipofthebatteryarrowaligns

withthetipofthebay1arrowonthewECGmodule.Thenslidethe

modulebatteryintobay1,pressinguntilitseatscompletely.

3Orientamodulebatterysothatthetipofthebatteryarrowaligns

withthetipofthebay2arrowonthewECGmodule.Thenslidethe

modulebatteryintobay2,pressinguntilitseatscompletely.

Step Action

Module battery

Bay 1 arrow

Battery arrow

Module battery

Bay 2 arrow

Battery arrow

1‐26ImportantInformationExpressionMR400InstructionsforUse

Toremovebattery2fromthewECGmodule

Pressabatteryejectbutton2(item3,right).Then

graspthepartiallyejectedmodulebattery(item4)

andpulltoremoveit.

Installing a Battery in the wSpO2 Module

ThewSpO2moduleusesonebattery.Whenamodulebatteryisinserted,thewSpO2modulewill

turnon.And,whenthebatteryisremoved,thewSpO2modulewillturnoff.

ToinstallabatteryinthewSpO2module

Step Action

1HoldthewSpO2modulesothatitsbatterybayisorientedas

shown.



2Orientamodulebatterysothatthetipofthebatteryarrowaligns

withthetipofthebayarrowonthewSpO2module.Thenslidethe

modulebatteryintothebatterybay,pressinguntilitseats

completely.

wSpO2 module

Battery bay

Module battery

Bay arrow

Battery arrow

Removing the Battery from the wSpO2 Module

ToremovethebatteryfromthewSpO2module

Pressthebatteryejectbutton(item1,right).Then

graspthepartiallyejectedmodulebattery(item2)

andpulltoremoveit.

Understanding Wireless Network Operations

AwirelessnetworkchannelisusedforsystemcommunicationbetweentheMR400cartandthe

wECGandwSpO2modules(and,ifequipped,theIP5).Allwirelessdevicesmustusethesame

wirelessnetworkchannelforpropersystemcommunications.Also,wheremultipleInvivo(Royal

Philips)MRIpatientmonitoringsystemsareinuse,theselectedwirelessnetworkchannelshould

benotusedbyanyothersysteminyourfacility(forthefrequencyrange,seepage1‐8).

Setting the Wireless Network Channel of the Cart

AllcontrolsforselectingthewirelessnetworkchanneloftheMR400arelocatedonthecart’s

touchscreen.Uniquesymbolsandnumbersareusedtoidentifyeachavailablechannelforthe

MR400,asshownbelow.

Network channel 1 Network channel 6

Network channel 2 Network channel 7

Network channel 3 Network channel 8

Network channel 4 Network channel 9

Network channel 5 Network channel 10

1‐28ImportantInformationExpressionMR400InstructionsforUse

WARNINGS

•Care should be taken to guard against inadvertent changes to the network channel

setting. Before use, always ensure that all devices are communicating properly. Failure

to do so may cause a lapse in patient monitoring.

• An MR400 system is comprised of one MR400 cart, one wECG module, and one

wSpO2 module, and optionally an IP5. In environments where multiple MR400 MRI

patient monitoring systems are being used, you must be aware of each component’s

network setting. Operating multiple MR400 systems on the same network or with a

wrong network setting will interfere with communications, and incorrect or corrupted

patient vital signs information will be displayed as a result.

Notes

• If a patient is currently admitted, a warning dialog box will prompt you before a change to

the monitor network is allowed.

• After changing the wireless network channel of the MR400, you must wait a minimum of 5

seconds before removing power from the system; otherwise, the change will be lost.

TosetthewirelessnetworkchannelfortheMR400cart

Step Action

1Pressthepowerswitch(seepage2‐7forthelocation)thenallow

theMR400toinitialize.

Themainscreenappears.

2 Selectthenetworkicon.

Thenetworkmenuappears.

Network icon

Network menu

Setting the Wireless Network Channel of the wECG and wSpO2 Modules

Allindicatorsandcontrolsforwirelessnetworkchannelselectionarelocatedonthefrontofthe

wirelessmodules.Twodifferentgroupsoffivewirelessnetworkchannelsareavailable(channels

1–5,orchannels6–10)andbothmodulesmustbeofthesamegroup,dependinguponyour

selectionattimeofpurchase.

Note

The wECG and wSpO2 modules may arrive preprogrammed to match the network channel setting

of your MR400, thus eliminating the need to change the channel setting.

Thewirelessnetworkchannelforamoduleischangedbyusingthe

networkselectionbutton.Thewirelessnetworkchannelfora

moduleshouldbesettomatchthewirelessnetworkchannelused

bytheMR400;seepage1‐27.

Thefollowingdirectionsforchangingthewirelessnetworkchannel

applytobothwirelessmodulesandtoeitherchannelgroup,though

theprocessbelowdepictsthewSpO2moduleandchannelgroup1–

5.(FormoreoperationaldetailsaboutthewECGmodule,seepage

2‐9;and,forthewSpO2module,seepage2‐11.)

3 Selectthedesiredsettingfromtheoptions:

Thesettingisenteredandthenetworkiconischangedtothe

currentselection.

4EnsurethatthenetworkchannelusedbythewECGandwSpO2

modules(seepage1‐29)andtheIP5(ifequipped)areidenticalto

thenetworksettingofthecart.

Step Action

1Network channel indicators

2Network selection button

1‐30ImportantInformationExpressionMR400InstructionsforUse

Beforestartingtheproceduretochangethenetworkchannelofthewirelessmodule,takenoteof

theseconventionsthatareusedtoexplaintheprocess:

•Thefollowingsymbolsareusedtoconveythestateofthenetworkchannelindicatorona

wirelessmodule.

•Thefollowingillustrationsareusedtoconveyactionsconcerningtheuseofthenetwork

selectionbutton.

TosetthewirelessnetworkchannelofthewECGorwSpO2module

Symbolilluminated Symbolblinking

Pressingthe

button

Pressingandholding

thebutton

Releasingthe

button

Repeating

Step Action

1Turnoffthewirelessmodule:

•wECGmodule—seeRemovingBatteriesfromthewECG

Moduleonpage1‐25.

•wSpO2module—seeRemovingtheBatteryfromthewSpO2

Moduleonpage1‐27.

2Turnonthewirelessmodule:

•wECGmodule—seeInstallingBatteriesinthewECGModule

onpage1‐24.

•wSpO2module—seeInstallingaBatteryinthewSpO2

Moduleonpage1‐26.

Thenetworkchannelindicatorswillflashbrieflyandthenthe

currentnetworkchannelindicatorwillilluminate(forexample,“3”

intheillustrationbelow).

3 Enterthenetworkchannelchangemode:Afterthecurrent

networkchannelindicatorhasbeenilluminated(andwithin10

secondsofmodulepower‐up),pressandholdthenetwork

selectionbuttonuntilthecurrentnetworkchannelindicatorbegins

torapidlyblinkthenreleasethebutton.

Note

If the network channel change sequence was not started within 10

seconds after the module has been turned on, network channel

changes will not be allowed. In this case, you must cycle module

power and restart the sequence.

4Pressdownagainonthenetworkselectionbuttonuntilthesymbol

stopsblinkingandthenreleasethebuttontochangethenetwork

channelsetting.

Whenyoudothis,thenextnetworkchannelindicatorinthe

sequencewillblinkrapidly.(Inotherwords,ifthemodulewas

originallyusingnetworkchannel“3,”nowthe“4”symbolwillbe

blinking.)Repeatthissequenceofpressingdownandreleasingthe

buttonuntilthesymbolofthenetworkchannelyoupreferis

rapidlyblinking.Ifyoupassthedesiredchannel,simplycontinue

pressingandreleasingthebuttonuntilthedesirednetwork

channelindicatorisblinkingagain.

Step Action

1‐32ImportantInformationExpressionMR400InstructionsforUse

5Whenyoureachthedesiredsymbol,pressandholdthebuttonfor

approximately5secondstolockandsavethenewsetting.

Theselectednetworkchannel'ssymbolwillturnoffwhilethe

buttonisdepressed.Thenitwillilluminate(notblink)whenthe

newnetworkchannelsettingissaved.Onceilluminated,release

thebutton.Themodulewillbeginusingtheselectednetwork

channel.

Note

Any part the network channel change sequence not completed will

cause the module to revert to the network channel previously set 30

seconds after the network selection button was last released.

Step Action

Advanced User Options

Expression Information Portal (Model IP5)

ProvidingsystemcontroloutsidetheMRmagnetroom,the

ExpressionInformationPortal(ModelIP5),hereafterreferred

toastheIP5,isawirelessdevicethatalsofeaturesprinting

capabilitiesandHL7dataoutputoptions.

TheMR400usesawirelessconnectionforcommunication

withtheIP5.TheIP5’sconnectiontothehospitalinformation

system(HIS)isexplainedindetailintheIP5IFU.Whenusing

theIP5toconnecttotheHIS,adheretoallcautionsandsafety

instructionsfoundintheIP5IFU.

Additional Options

Additionaloptionsmaybesuggestedbyyourbiomedicaltechniciantoincreaseuserease.

Consultyourbiomedicaltechnicianortechnicalsupportwithspecificrequests.

Caution

CAUTIONS

• When adding equipment to an MR400 system (for example, an IP5), be aware that all

devices should be at the same or a compatible software revision level. Contact technical

support if you have questions or to upgrade software. Failure to observe this requirement

could result in compatibility conflicts, communication problems, et cetera.

• Unauthorized modification to the radios/and/or antennas may cause the device to no longer

be in compliance with applicable regulatory standards

• The manufacturer is not responsible for any radio frequency interference caused by

unauthorized modifications to the radios and/or antennas within this equipment. Such

modification could inhibit proper MR400 system or device communications.

Accessory List

Accessoriesarelistedinthetablesbelowwithpartnumber(REF)information.Whereapplicable,

theoriginalpartnumberhasalsobeenincludedforreference.Foradditionalinformationabout

theseaccessories,pleaseconsultthedocumentationthataccompaniestheaccessory.

1‐34ImportantInformationExpressionMR400InstructionsforUse

Warning

WARNING

The MR400 has been validated with all of the accessories listed below. Only use these

specified accessories as other types or brands may compromise the safety and accuracy of

the MR400. Patient injury or loss of monitoring may result if incorrect accessories are used.

Warning

WARNING

Do not use sterile items if the packaging is damaged. Patient injury may result if non-sterile

accessories are used.

CAUTION

Modifications to the MR400 System during its service life are required to be evaluated to the

requirements of IEC 60601-1.

AGENT Original Part Number REF

CANNULA, DISP, ADULT 9012 989803152561

CANNULA, DISP, ADULT 9016 989803152601

CANNULA,DISP,INT INF,(DIVIDED) 9016B 989803152621

CANNULA,DISP,PED,(DIVIDED) 9016C 989803152631

CANNULA,DISP,INFANT,(DIVIDED) 9016A 989803152611

CANNULA, DISP, INT INFANT 9015 989803152591

CANNULA, DISP, PED 9013 989803152571

CANNULA, DISP, INFANT 9014 989803152581

ANESTHETIC OXYGEN (O2) SENSOR — 989803162051

KIT,DISPOSABLE WATER TRAP,3160 94012 989803152671

KIT,SAMPLE,AGENTS,3160 94018 989803152661

CO2 REF

LOFLO SAMPLE LINE, ADULT CANNULA, BOX 20 989803183241

LOFLO SAMPLE LINE, PED. CANNULA, BOX 20 989803183251

LOFLO SAMPLE LINE, NEO. CANNULA, BOX 20 989803183261

LOFLO LINE, ADU DVD CANNULA,BOX 20 989803183271

LOFLO LINE, PED DVD CANNULA, BOX 20 989803183281

LOFLO LINE, ADU AIRWAY ADPT, BOX 20 989803183291

LOFLO SAMPLE LINE, ADULT CANNULA,BOX 100 989803185331

LOFLO SAMPLE LINE, PED CANNULA, BOX 100 989803185341

LOFLO SAMPLE LINE, NEO CANNULA, BOX 100 989803185351

LOFLO LINE, ADU DVD CANNULA, BOX 100 989803185361

LOFLO LINE, PED DVD CANNULA, BOX 100 989803185371

LOFLO LINE ADU AIRWAY ADPT, BOX 100 989803185381

CO2 REF

ECG Original Part Number REF

GEL, ECG/EEG, SKIN PREP, TUBE, 3-PACK 9009 989803152291

EXPRESSION MR ECG LEADS, AAMI, CV — 989803193721

EXPRESSION MR ECG LEADS, AAMI, STANDARD — 989803193731

EXPRESSION MR ECG LEADS, AAMI, NEONATAL — 989803193741

EXPRESSION MR ECG LEADS, IEC, CV — 989803193751

EXPRESSION MR ECG LEADS, IEC, STANDARD — 989803193761

EXPRESSION MR ECG LEADS, IEC, NEONATAL — 989803193771

QUADTRODE MRI ECG PAD, 25/BOX — 989803179031

ELCTRD, MRI ECG, QUTRD.CV, 25/BOX — 989803179041

ELCTRD, MRI, NEO.QUDTRD, 25/BOX — 989803179051

WIRELESS ECG PATIENT MODULE (GEN 3) 1-5 — 989803192761

WIRELESS ECG PATIENT MODULE (GEN 3) 6-10 — 989803194341

Gating Original Part Number REF

CAB, DIGITAL GATING, GE, 3160 9292 989803152821

CAB, GATING, SIEMENS, 3160 9291 989803152831

UNIVERSAL GATING INTERFACE — 989803195521

CAB, DIG.GATING, HIT/TOSH, 3160 9293 989803152851

1‐36ImportantInformationExpressionMR400InstructionsforUse

Invasive Blood Pressure REF

EXPRESSION MR IBP TRANSDUCER CABLE, 5FT 989803194601

EXPRESSION MR IBP DPT KIT, A/P, BOX 20 989803194631

EXPRESSION MR IBP DPT KIT, I/N, BOX 20 989803194641

(Note that Hospira [Transpac models], and Edwards Lifesciences [Transducer, Model PX260 and adapter cables],

have also been qualified for use. Please contact Hospira or Edwards Lifesciences for information about Invivo-

compatible devices, and contact your sales representative with any questions.)

Non-invasive Blood Pressure (NIBP) REF

NIBP CUFF, SINGLE LUMEN, INFANT 989803182611

NIBP CUFF, SINGLE LUMEN, PEDIATRIC 989803182621

NIBP CUFF, SINGLE LUMEN, SMALL ADULT 989803182631

NIBP CUFF, SINGLE LUMEN, ADULT 989803182641

NIBP CUFF, SINGLE LUMEN, ADULT-L 989803182651

NIBP CUFF, SINGLE LUMEN, LRG ADULT 989803182661

NIBP CUFF, SINGLE LUMEN, LRG ADULT-L 989803182671

NIBP CUFF, SINGLE LUMEN, THIGH 989803182681

NIBP CUFF, SINGLE LUMEN, INFANT, DISP 989803182511

NIBP CUFF, SINGLE LUMEN, PEDIATRIC, DISP 989803182521

NIBP CUFF, SINGLE LUMEN,SMALL ADULT,DISP 989803182531

NIBP CUFF, SINGLE LUMEN, ADULT, DISP 989803182541

NIBP CUFF, SINGLE LUMEN, ADULT-L, DISP 989803182551

NIBP CUFF, SINGLE LUMEN, LRG ADULT, DISP 989803182561

NIBP CUFF, SINGLE LUMEN,LRG ADULT-L,DISP 989803182571

NIBP CUFF, SINGLE LUMEN, THIGH, DISP 989803182581

NIBP CUFF, SINGLE LUMEN, NEO #1, DISP 989803183171

NIBP CUFF, SINGLE LUMEN, NEO #2, DISP 989803183181

NIBP CUFF, SINGLE LUMEN, NEO #3, DISP 989803183191

NIBP CUFF, SINGLE LUMEN, NEO #4, DISP 989803183201

NIBP CUFF, SINGLE LUMEN, INFANT #5, DISP 989803183211



ADULT PRESSURE INTERCONNECT HOSE 989803183221

NEONATAL PRESSURE INTERCONNECT HOSE 989803183231

Non-invasive Blood Pressure (NIBP) REF

Respiration (Pneumatic) Original Part Number REF

PNEUMOGRAPH,CHEST,NM,3160 94023 989803152791

SPO2 REF

QUICK CONNECT SPO2 PROBE, MRI 989803161991

QUICK CONNECT SPO2 CLIP, ADULT 989803166531

QUICK CONNECT SPO2 CLIP, PEDIATRIC 989803166541

QUICK CONNECT SPO2 GRIP, ADULT, 20/BOX 989803166551

QUICK CONNECT SPO2 GRIP, PED, 20/BOX 989803166561

QUICK CONNECT SPO2 GRIP, INFANT, 20/BOX 989803166571

QUICK CONNECT SPO2 GRIP, NEO, 20/BOX 989803166581

WIRELESS SPO2 PATIENT MODULE (GEN 3) 1-5 989803192771

WIRELESS SPO2 PATIENT MODULE (GEN 3) 6-10 989803194331

System REF

BATTERY, MODULE (GEN 3) 989803191341

BATTERY, MRI, 14.8V, 5.08 AH, UL 989803169491

EXPRESSION INFORMATION PORTAL (IP5) 865471

ADVANCED COMMUNICATIONS OPTION 989803176521

EUROPEAN LINE CORD 453564177501

NORTH AMERICAN LINE CORD 989803168211

CORD, JUMPER, 25 FEET 989803168221

BRAZILIAN POWER CORD, 3 METER 989803173901

UK LINE CORD, 3 METER 989803174171

POWER CORD, AUS/NZL, 3 METER 989803181291

POWER CORD, S AFRICA, 3 METER 989803181321

1‐38ImportantInformationExpressionMR400InstructionsforUse



POWER CORD, DANISH, 3 METER 989803181331

POWER CORD, ISRAELI, 3 METER 989803181341

POWER CORD, ARGENTINA, 3 METER 989803181351

POWER CORD, SWISS, 3 METER 989803181361

System REF

Te m p e r a t u r e REF

FLEXTEMP II SENSOR (ESOPHAGEAL/RECTAL/AXILLARY, DIRECT MODE) 989803194511

SURGICAL LUBRICANT, 12 PACK 989803168891

FLEXTEMP SYSTEM, JACKET (BOX 10) 989803178181

Miscellaneous REF

MR400 QUICK REFERENCE GUIDE 453564557591

MANUAL, SERVICE, MR400 989803195211

MANUAL, OPERATOR, MR400, DANISH 989803193191

MANUAL, OPERATOR, MR400, DUTCH 989803193201

MANUAL, OPERATOR, MR400, ENGLISH 989803193211

MANUAL, OPERATOR, MR400, FINNISH 989803193221

MANUAL, OPERATOR, MR400, FRENCH 989803193231

MANUAL, OPERATOR, MR400, GERMAN 989803193241

MANUAL, OPERATOR, MR400, INDONESIAN 989803193251

MANUAL, OPERATOR, MR400, ITALIAN 989803193261

MANUAL, OPERATOR, MR400, JAPANESE 989803193271

MANUAL, OPERATOR, MR400, KOREAN 989803193281

MANUAL, OPERATOR, MR400, NORWEGIAN 989803193291

MANUAL, OPERATOR, MR400, POLISH 989803193301

MANUAL, OPERATOR, MR400, PORTUGUESE 989803193311

MANUAL, OPERATOR, MR400, RUSSIAN 989803193321

MANUAL, OPERATOR, MR400, SPANISH 989803193331

MANUAL, OPERATOR, MR400, SWEDISH 989803193341

MANUAL, OPERATOR, MR400, TRAD. CHINESE 989803193351

MANUAL, OPERATOR, MR400, TURKISH 989803193361

Miscellaneous REF

1‐40ImportantInformationExpressionMR400InstructionsforUse

ExpressionMR400InstructionsforUseSystemOverview2‐1

CHAPTER 2

System Overview

TheMR400isdesignedtoprovidemulti‐vitalsignpatientmonitoringandMRIgatingcapabilityin

theMRIenvironmentwhileincloseproximitytoanMRIscannermagnet.Themonitoring

capabilitiesoftheMR400canbeconfiguredtomeettheneedsofawidespectrumofpatients

fromneonatetoadult.Everyparametercanbeaccessedandadjustedfortheuniqueconditionof

eachpatient.TheMR400accommodatesspecificmonitoringneeds,including:

•Adult,pediatricandneonatalpatients

•Criticallyillpatients

•Patientundergoingsedation

•PatienttransportwithintheMRenvironment

• Interventionalprocedures

•Cardiacgating

Note

We recommend the establishment of a program for supervision appropriate to the classes and

types of patients, and that all patients should receive at least routine monitoring when the MR400

is in use.

System Parameters

TheMR400simultaneouslyprocessesanddisplaysmultipleparameters,waveforms,

measurementnumericvaluesandalarms.Allpatientinformationisprovidedonthetouch

screen.AfullyequippedMR400includesmonitoringforthefollowingparameters:

• Electrocardiogram(ECG),dualchannel

•Heartrate(HR)

•Bloodoxygensaturation/pulseoximetry(SPO2)

•End‐tidalandfractionalinspiredCO2(EtCO2andFiCO2)

•Invasivebloodpressure(P1andP2)

•Anestheticagents(AGENT)

•FractionalinspiredO2(FiO2),andend‐tidalandfractionalinspiredN2O(EtN2OandFiN2O)

• Temperature(TEMP)

2‐2SystemOverviewExpressionMR400InstructionsforUse

•Non‐invasivebloodpressure(NIBP)

• Respirationrate(CO2orbellows)

Note

Depending upon the equipped options, your MR400 may not have all indicated parameters.

System Components

Beforeuse,familiarizeyourselfwiththeMR400anditscomponents.AcompleteMR400system

consistsofthefollowingcomponents:

• MR400cart

•wECGmodule

•wSpO2module

•Modulebatterycharger

• Batteriesandotheraccessoriesasneeded

•Optional:IP5withorwithoutaprinter

Use Model

TheMR400isintendedtobeusedtomonitorthevitalsignsofapatientinanMRmagnetroom,

asillustratedbelow.ThewECGandwSpO2modulescommunicateviawirelesslinkstosupplythe

patient’smeasuredECG,SPO2,andbellows‐derivedrespirationsignalstotheMR400.Thegating

cableisonlyrequiredforMRItriggeringandsynchronizationbasedonthepatient’sECGorSPO2

signals.WhenpairedwithanoptionalIP5,monitoringcapabilitycanbeextendedviawirelesslink

toanMRcontrolroom,inductionroom,orrecoveryroomenvironment.Datatransmittedfrom

theMR400toanIP5canbeoutputtoanoptionalstripchartprinterortothehospitalinformation

system(HIS).

Acquisition and Control

UseoftheMR400isrestrictedtoonepatientatatime.TheMR400displayspatient

measurementsacquiredduringmonitoring.Controlsandsettingsforpatientmonitoringare

providedlocallyonthetouchscreenorremotely(forexample,intheMRIcontrolroom)when

equippedwiththeIP5,whereconnectionsfortheprinterandthehospitalnetworkarealso

available.

Synchronization

TheMR400willautomaticallyestablishcommunicationwiththewirelessmodules,andIP5(if

equipped).However,duetotheusemodel,thedevicescanestablishcommunicationand

synchronizepower‐onsettingsaccordingtothestart‐upsequence:

•IftheMR400bootsandcommunicatesfirst,thenitssettingswillbereflectedattheIP5.

•IfanIP5bootsandcommunicatesfirst,thenitssettingswillbereflectedattheMR400.

IfusinganIP5,patientidentifiableinformation(nameandIDnumber)willbeavailableafter

synchronizationoccurs.

MR400

IP5

Hospital network

HIS system

MRI magnet room

MRI control room

Patient

table

MR400 to IP5 (wireless)

Modules to MR400

(wireless)

USB

Ethernet

Printer

Gating cable

2‐4SystemOverviewExpressionMR400InstructionsforUse

WARNINGS WARNINGS

•The use model specifies one IP5 per MR400 system. If more than one IP5 is present on

the MR400 system, there is an increased risk of units within the system not

synchronizing and displaying incorrect or corrupted settings.

• The MR400 should not be used adjacent to or stacked with other equipment. If

adjacent or stacked use is necessary, the equipment or system must be observed to

ensure normal operation in the configuration in which it will be used.

CAUTION

If the monitor’s settings are adjusted since they were last recalled or stored (manually, or via

synchronization if using an IP5), the User Settings key (see page 2-15) will be appended with a

plus symbol (+). The symbol will only be removed if the current settings are saved (see page 3-15)

or if different settings are recalled (see page 3-26). Always confirm the proper settings for the

MR400 and IP5 to ensure expected monitoring functionality.

Note

See Default Settings (on page 3-7) for information about the system’s power-on setup.

Device Control

Menucommandsthatcontrolparameterfunctionsforpatientmonitoringaresynchronized

betweentheMR400andIP5.Commandsthatdonotdirectlycontrolpatientparameters(for

example,printerfunctions)willonlyaffecttheIP5.Othercontrolsettingsremainlocalizedtothe

IP5andarenotsynchronizedwiththeMR400,includingthealarmaudiooffandalarmaudio

pausefunctions,andthevolumesettings;seetheIP5IFUforacompletelisting.

Note

If a systemic failure of the processing hardware, software or communications renders an intended

task incomplete and unperformed, a watchdog circuit will automatically shutdown power to the

WPU portion of the MR400. This will result in the removal of all patient data and displayed

information, and a continuous alarm will sound until power to the MR400 is turned off. If this

problem persists, contact technical support.

Hardware Features

Cart

DesignedforuseintheMRmagnetroomandthroughouttheMRsuite,theMR400isaself‐

containedmobilepatientmonitoringsystem.TheMR400featuresawheeled‐cartdesignwith

fourlargelockablecastersunderitsaluminumframeandincludesintegratedsystemsfor

processing,power,displayandcontrol,asoutlinedbelow.

1Display panel (see page 2-6 for details).

2Guide handles provides the means for positioning the cart; see

page 3-2 for details.

3Patient connection panel (see page 2-7 for details).

4Accessory hooks provide storage for sampling lines, cables, et

cetera.

5Battery compartments house the main batteries; see page 1-16

details.

6Casters with wheel locks that, when engaged, prevent

movement of the cart.

2‐6SystemOverviewExpressionMR400InstructionsforUse

Display Panel

ThedisplaypanelincludesatouchscreenLCD(liquidcrystaldisplay),thealarmindicatorsandan

audiospeaker.Thedisplaypanelcanbetiltedbackwardorforwardtoachievethebestviewing

angleandreduceanyglareonthetouchscreenproducedbyambientlighting.

CAUTION

Never use the display panel to position the MR400; severe damage or failure can result. Only use

the guide handle to position the MR400. If breakage of the display panel glass does occur and you

contact the liquid crystal by chance, please wash it from your skin using soap and water.

7Storage basket provides storage for Quadtrodes, cuffs, SPO2

attachments and other small accessories; see page 2-12 for

details.

8Module holders provide storage for the wECG and wSpO2

modules; see page 2-12 for details.

9Wireless processing unit (WPU) houses the communication,

processing and power systems for the MR400.

10 Rear panel houses connections for AC mains power, earth

ground, gating, USB port (service use only), (optional) waste gas

output, and (optional) O2 sensor.

1Touch screen provides displayed information and control of

the MR400, and can be used with gloved fingers.

2Alarm light provides a visual indication of an alarm condition.

3Speaker provides all audible indications.

4USB port provides service-related functions.

Patient Connection Panel

ThepatientconnectionpanelcontainsthepowerswitchandLED,andinputconnectionsfor

variouspatientaccessories.

Note

The illustration shown below features a composite of all available options. Your MR400 will not

have all of these options.

1NIBP interconnect hose port

2(Optional) Loflo CO2 sampling line port

3(Optional) Temperature port

4(Optional) AGENT sample port

5(Optional) AGENT water trap

6(Optional) Invasive blood pressure ports (P1 and P2)

7Power switch (standby switch) is a push-type latching switch that

controls power (AC mains or batteries) to the MR400

8Power LED indicates the power source and power status of the

MR400, as detailed in the table below

Power LED Condition / Meaning

Color State Power Source Power

Switch

None Off None (batteries may be installed) Off

Green Steady Depending upon power source:

• If AC is present, then AC mains

• If AC is not present, then

batteries

2‐8SystemOverviewExpressionMR400InstructionsforUse

wECG and wSpO2 Modules

ThewECGandwSpO2modulesarebatterypoweredandcommunicatewiththeMR400through

abidirectional2.4GHzRFlink,whichisautomaticallyestablishedapproximately30secondsafter

powerisappliedtothemodule.Thesewirelessmodulesoperateatadistanceofupto9.1m(30

feet)fromtheMR400cartwhenalldevicesareplacedwithinthesameMRIroomorwithinthe

sameshieldedroom.

Thenetworkchannelandbatteryindicatorsdenotetheselectednetworkchannelandthe

batterystatusforeachwirelessmodule.Aftercommunicationshavebeenestablished,all

module‐dependentvitalsigninformationwillbedisplayedwithin10secondsontheMR400.

WARNING

The system use model specifies one wECG module and one wSpO2 module per MR400

system network channel. If more than one type of each module is communicating on the

same network channel, then waveform and measurement corruption will occur.

Red Steady Power fault detected; contact technical

support.

N/A

Blue Blinking Batteries are charging Off

Blue Steady Batteries at full charge Off

Power LED Condition / Meaning

Color State Power Source Power

Switch

wECG Module

ThewECGmoduletransmitsmeasuredECGsignalsthroughtheRF

linktotheMR400,wheretwoECGsignalscanbedisplayedandare

availableforinterfacingwiththeMRsystemcardiacgatinginput.

ThemodulealsoreceivesinformationfromtheMR400toperform

commandedtasks(forexample,leadviewandfiltermode

selections).

wECG Module Indicators

BatteryindicatorsprovidechargestatusindicationsforeachbatteryusedbythewECGmodule,

asdetailedinthetablebelow.

Notes

• A battery time-remaining counter is displayed by the MR400; see page 2-16 for details.

• For battery replacement details, see page 1-24.

1Battery 1 eject button

2Batteries

3Battery 2 eject button

4Battery 1 indicator

5Battery 2 indicator

6Network channel indicators (1–5, in this example)

7Network selection button

8ECG lead cable connector

wECG Battery

Indicator Color Charge Status

None Battery not installed in battery bay 1, or the battery’s

charge is insufficient to power the module

Green Battery installed in battery bay 1 has sufficient charge

Red Battery installed in battery bay 1 has low charge

None Battery not installed in battery bay 2, or the battery’s

charge is insufficient to power the module

Green Battery installed in battery bay 2 has sufficient charge

Red Battery installed in battery bay 2 has low charge

2‐10SystemOverviewExpressionMR400InstructionsforUse

Networkchannelindicatorilluminatestoprovidethewirelessnetworkchannelindicationand

thestatusofthewECGmoduletoMR400communications,asdetailedinthetablebelow.

Notes

• The communication status is also displayed by the MR400; see page 2-16 for details.

• For network channel selection details, see page 1-29.

Network Channel

Indicator Channel Selected Network Channel

Indicator Channel Selected

Channel 1

Channel 6

Channel 2

Channel 7

Channel 3

Channel 8

Channel 4

Channel 9

Channel 5

Channel 10

Network Channel Indicator State Communication Status

Steady Good communication

Flashing No communication

wSpO2 Module

ThewSpO2moduletransmitsmeasuredbloodoxygensaturation,

plethysmography,peripheralpulsedataandpneumaticrespiration

ratevaluesthroughtheRFlinktotheMR400,wheretheprocessed

informationcanbedisplayedandoutputforinterfacingtotheMR

systempulseperipheralandrespirationgatinginput.

wSpO2 Module Indicators

BatteryindicatorprovideschargestatusindicationsforthewSpO2module,asdetailedinthe

tablebelow.

Notes

• A battery time-remaining counter is displayed by the MR400; see page 2-16 for details.

• For battery replacement details, see page 1-26.

Networkchannelindicatorilluminatestoprovidethewirelessnetworkchannelselection

indicationandthestatusofthewSpO2moduletoMR400communications,asdetailedinthe

tablebelow.

1Battery eject button

2Battery

3Battery indicator

4Network channel indicators (1–5, in this example)

5Network selection button

6Pneumatic respiration port; see page 10-2

7SPO2 probe connector; see page 1-18

wSpO2 Battery

Indicator Color Charge Status

None Battery not installed or its charge is insufficient to power

the module

Green Battery charge sufficient

Red Battery charge low

2‐12SystemOverviewExpressionMR400InstructionsforUse

Notes

• The communication status is also displayed by the MR400; see page 2-16 for details.

• For network channel selection details, see page 1-29.

Storing Modules and Accessories

WARNINGS WARNINGS

•Never store items containing ferrous materials on the cart or in the storage basket.

Failure to observe this warning may result in serious injury.

• To reduce the spread of infection, never store accessories on the cart guide handles.

CAUTION

When storing or removing the wECG and wSpO2 modules from the module holders, grasp only

the module and never pull or apply excessive force or tension to any connected attachment.

Network Channel

Indicator Channel Selected Network Channel

Indicator Channel Selected

Channel 1

Channel 6

Channel 2

Channel 7

Channel 3

Channel 8

Channel 4

Channel 9

Channel 5

Channel 10

Network Channel Indicator State Communication Status

Steady Good communication

Flashing No communication

TostorethewECGmoduleandaconnectedECGleadcable

LooptheECGcabletrunkwithfoaminsulatorandsecureitusingthe

Velcrostoragestrap(seepage5‐2).Then,placethewECGmodule

intoamoduleholderandallowtheECGleadcabletodrape.

WARNING

Do not use the Velcro storage strap to loop the ECG lead cable

during MR scanning; otherwise, there is a risk of cable heating

and possibly skin burns.

CAUTION

Failure to loop the Velcro storage strap on the ECG cable trunk may

result in damage to the lead cable due to contact with the floor.

TostorethewSpO2moduleandaconnectedprobe

PlacethewSpO2moduleintoamoduleholderandallowtheSPO2

probetodrape.

Tostoresmallaccessories,samplelinesandthetemperaturesensor

•Usetheremovablestoragebaskettoholdsmallaccessories(Quadtrodes,SPO2clipsand

grips,etcetera).Toremovethestoragebasketfromthecart,graspthebasketandlift.

•Usetheaccessoryhookstohangloopedsamplelines,thetemperaturesensor,etcetera.

CAUTIONS

• Do not place more than 2.2 kg (5 pounds) of combined weight of items in the storage

basket, module holders and accessory hooks.

• Never stack items onto or drape objects over the guide handle.

Displayed Information and Controls

ThedisplayedinformationandcontrolsfortheMR400aregroupedonthetouchscreen

accordingtofunction.

Note

The example below depicts information displayed by a fully-equipped MR400. Information

displayed by the MR400 will vary according to the equipped options and activated parameters. If

a parameter (or an ECG trace) has been turned off, its portion of the display will be blank. To

turn a parameter on or off, use Parameters in the Monitor Setup menu; see page 3-18 for details.

2‐14SystemOverviewExpressionMR400InstructionsforUse

Information Bar

Theinformationbarprovidesgeneraluse,vitalsigndetectionandpatientinformation.

1Information bar

2Soft keypad

3Status information pane

4Vital sign boxes

5Vital sign traces

1Set Time indication, and when pressed accesses the date; see

page 3-13.

2Alarm sound state indication; see page 4-4.

3Heart beat detection indication (and provides a detection tone)

according to the HR Tone Source setting; see page 3-21.

4Respiration detection indication when CO2-derived respiration is

on and within specified limits, flashing at a frequency that matches

the current breath rate.

1234 8

6 7

Soft Keypad

Thesoftkeypadprovidesimmediateaccesstofrequentlyusedmenusandfunctions.

5Alarm Light setting indication; see 4-20.

6Patient information area, which displays the patient’s name and

identifier (ID) when available from an IP5.

7 Patient Type key and the current patient type setting indication;

and, when pressed, accesses the Patient Type menu (see page 3-

11).

8 User Settings key and user settings file name indication (where

the plus symbol [+] indicates that changes have occurred); and,

when pressed, allows you to select a factory or a stored user setup

(see Edit User Settings on page 3-15).

1 Main Screen key returns the MR400 to normal mode, closing any open menu,

option or dialog box

2Print key controls the remote print function and indicates the current state of

the printer

3 Trends key accesses the Tabular Trends menu

4 NIBP Start/Stop key starts or stops an NIBP measurement

5 ECG Filter key accesses the ECG Filter Mode options

2‐16SystemOverviewExpressionMR400InstructionsforUse

Status Information Pane

ThestatusinformationpaneprovidesindicationsfortheMR400andwirelessdevices:

• Communicationandpowerindicationswillbedisplayedwithin2seconds.

6 Suspend key places the MR400 in suspend mode

7 Audio Pause key temporarily deactivates alarms

8Alarm key acknowledges an active alarm

91-Touch Alarms key sets all alarm limits according to preset calculation

values

10 NIBP Interval key accesses the automatic measurement Interval options

11 Clear Trends key clears stored trend data

12 Zero All key zeros all active invasive blood pressure channels

13 Setup key accesses the Monitor Setup, Printer, and Alarms menus

1Monitor network icon, which indicates the selected wireless

network channel (1, in this example) and, when pressed, allows you

to select the channel used by the MR400; see Setting the Wireless

Network Channel of the Cart on page 1-27 for details.

2Indicates the battery time-remaining (given in an hours:minutes

format) until power will be exhausted for the wSPO2 module; also,

indicates that the wSPO2 module’s communication with the

MR400 is good.

•Powersourcechange‐of‐stateindicationsaredisplayed.

3Indicates the battery time-remaining (given in an hours:minutes

format) until power will be exhausted for the wECG module; also,

indicates that the wECG module’s communication with the MR400

is good. For detailed battery information regarding the wECG

module batteries, see Status Information Panel on page 2-18.

4Indicates the current power type used by the MR400 (AC power in

this example).

5Indicates that an IP5 is communicating with the MR400.

1Indicates a low battery condition and the approximate time (given

in an hours:minutes format) until power will be exhausted for a

module battery (wSpO2 in this example); also, indicates that the

module’s communication with the MR400 is good.

WARNING

A red battery symbol indicates that the module

batteries have fallen below the required operational

output and module shutdown with loss of monitoring

will occur. Immediately replace the module batteries to

avoid a loss in monitoring.

2Indicates that the cart batteries are the current power type used by

the MR400 and the approximate time (given in an hours:minutes

format) until power will be exhausted.

WARNING

A red battery symbol indicates that the main batteries

in the MR400 have fallen below the required

operational output and system shutdown with loss of

monitoring will occur. Immediately locate an AC outlet

and connect the MR400 to avoid a loss in monitoring.

2‐18SystemOverviewExpressionMR400InstructionsforUse

• Indicationsareprovidedforalossofcommunication,whichisindicatedwithin2seconds,

andanodatacondition(seepage2‐20)willbedisplayedwithin10secondsforallvitalsign

informationmissingduetoanon‐communicatingwirelessmodule.

Status Information Panel

Thestatusinformationpanelprovideswirelesscommunicationandpowerdetails,includingthe

chargelevelofallconnectedbatteries.

Toopenthestatusinformationpanel

Selectthetitlearea(1,below)onthestatusinformationpane.

1Indicates that no communication is occurring between the MR400

and a wireless module (wECG in this example), or between the

MR400 and the IP5.

2Indicates a status warning when a communication error between

the MR400 and a wireless module, or between the MR400 and an

IP5 is detected.

Vital Sign Boxes

Vitalsign(VS)boxesareuniquelycoloredandlabeledgraphicframesthatcontainthenumeric

measurementsandcurrentalarmlimitssettingsforeachmonitoredparameter.Trending

indications(arrows)areavailableforeachmonitoredvitalsign,exceptNIBP.Inaddition,theVS

boxes(exceptAGENTandGAS)accesstheassociatedparameter’smenu.

1ECG VS box provides electrocardiogram and heart rate

measurements.

2SPO2

VS box provides blood oxygen saturation/pulse oximetry

and the heart rate measurements from pulse detection.

3CO2 VS box provides CO2 measurements and can also provide

respiration measurements.

4P1 VS box provides invasive blood pressure measurements for

channel 1 when equipped with the invasive blood pressure

option.

5P2 VS box provides invasive blood pressure measurements for

channel 2 when equipped with the invasive blood pressure

option.

6GAS VS box provides the total MAC value, O2 and N2O

measurements when equipped with the AGENT option.

7AGENT VS box provides anesthetic agent measurements

when equipped with the AGENT option.

8RESP VS box provides respiration rate measurements from

CO2 or the bellows accessory.

10 6

2‐20SystemOverviewExpressionMR400InstructionsforUse

No Data Indications

Undercertainconditions,nowaveformsandoneormorevitalsignnumericsmaydisplaythree

dashes(‐‐‐),whichindicatesthatnodataisavailablefortheparameter(s).

Dependinguponthecauseofthismissingdata,analarmconditionmaybegenerated.

Nodataindicationsthatmaynotgenerateanalarm

•Ifamoduleoranothermeasurementdevicewasjustturnedonorappliedtothepatient,

allowafewsecondsforcommunicationtobeestablished,orforanyrequiredwarm‐up

periodtooccur.

•Thefirstreadinghasnotyetbeentakenortheparameterisinastart‐upcondition(for

example,theAGENTorCO2monitoringhardwaremaybewarmingup).

•Themeasurementvaluesaredistortedorthesignalisinadequate(forexample,the

concentrationofgasesmaybebelowtheminimumvolumepercentagedetectable).

• Suspendmodewasjustexited.

Nodataindicationsthatmaygenerateanalarm

• Parameterdatawaspresentbutcannolongerbeproduced(forexample,anattachment

appliedtoapatientmayhavebecomedisconnected).

•Thehardwareassociatedwithaparameterhasexperiencedaproblemorfailurethat

preventsproperoperation.

9TEMP VS box provides temperature measurements when

equipped with the temperature option.

10 NIBP VS box provides non-invasive blood pressure

measurements.

Other Data Indications

TheOverStateIndication(OVR)

Ifthevalueofthenumericdataiteminthevitalsignboxisgreaterthanthehighestvalue

specifiedfortheitem,OVRwillbedisplayedinanalarmconditioninplaceofthenumeric.Seethe

tableonpage4‐25formeasurementrangeanddeclarationinformation.

TheUnderStateIndication(UND)

Ifthevalueofthenumericdataiteminthevitalsignboxislessthanthelowestvaluespecifiedfor

theitem,UNDwillbedisplayedinplaceofthenumericinanalarmcondition.Seethetableon

page4‐25formeasurementrangeanddeclarationinformation.

Vital Sign Traces and System Message Area

Vitalsign(VS)tracesareuniquelycoloredwaveformsfortheECG,SPO2,CO2andinvasiveblood

pressureparameters.Thesetracesarefixedacrossthescreen,adjustableandupdatedfromleft

torightwithanerasebar.ThewaveformcolorcorrespondstothecoloroftheassociatedVSbox

numericdataforthatparameter.Uptosixwaveformscanbedisplayed,butifaparameteris

turnedoffthenthattraceportionofthescreenandVSboxwillbeblank.

Systemmessagesandsomealarmflags,asdetailedthroughoutthismanual,aredisplayedinthe

centerandtopportionsofthevitalsigntracesarea.Multiplesystemmessagesoralarmflagswill

bestackedinthisarea.

1Trace A displayed as the ECG 1 waveform depending upon the

selected source

2Trace B displayed as the ECG 2 waveform when two ECG

sources are selected

3Trace C displays the SpO2 waveform

2‐22SystemOverviewExpressionMR400InstructionsforUse

Navigation and Operation

EverythingneededtonavigateandoperatetheMR400canbeperformedbyselectinganactive

elementonthetouchscreen(includingsoftkeysandbuttons,icons,menus,VSboxesandalarm

limitssettings).Whenanactiveelementistouchedwithafingerorapassiveobject(suchasa

stylus),theMR400willhighlightthatoptionoritem,produceatoneandenacttheselection.

CAUTION

Never apply unnecessary pressure or use sharp objects on the touch screen as damage or failure

can result. If breakage of the display panel glass does occur and you contact the liquid crystal by

chance, please wash it from your skin using soap and water.

Notes

• Simultaneously touching two or more screen areas may produce unpredictable results and

is not recommended.

• The design of the MR400 allows access to the same menus in different ways.

• The MR400 monitors all application processes. If a software process or an application

monitoring failure is detected, then an audible alarm will sound and all visual information

will be removed from the display. To restore normal operation, you must turn the power

switch off and then on. If the problem persists, contact technical support.

Specialized Control Buttons and Keys

Inadditiontothecontrolmethodsdescribedabove,somemenus,optionsanditemsinclude

specializedsoftkeysandbuttonsthatcontrolmenus,settingsandentries:

•Todecrementanumericvalue,select.

•Toincrementanumericvalue,select.

4Trace D displays the CO2 respiration waveform (breath rate)

5Trace E displays invasive blood pressure, channel 1 (P1)

waveform

6Trace F displays invasive blood pressure, channel 2 (P2)

waveform

7 System message area displays system messages and alarm flags;

see chapter 4.

•Tocloseamenuoritem,select.

•Toclearanentryfield,select.

•Tosaveentereddataandcloseamenuoritem,select.

•Toenterdata,savechangesandcloseamenuoritem,select.

Default Setting Indications

Thedefaultsettingofamenuappearsasthehighlighteditem,orastheitemwithanasteriskina

menu.

System Messages

Systemmessagesaredisplayedtoinformyouaboutacurrentoperationorcondition,as

discussedthroughoutthismanual.AlsoseeSystemStatusIndicationsonpage4‐31.

Password Protection

Entryofasix‐digitpasswordisrequiredforaccesstosome

menus,especiallyservice‐relatedmenus.(Contacttechnical

supportforinformation.)

WhenEnterPassword:isdisplayed,usethekeypadtoenterthe

correctpasswordtocontinuetothedesiredmenu.

Modes of Operation

TheMR400hasthreeoperatingmodes:normal,suspend,andsimulation.

Normal Mode

Normalmodeisthestandardoperatingmode.Innormalmodetherearenoopenmenusor

highlightedvitalsignboxes;thesystemisreadyformonitoring.

2‐24SystemOverviewExpressionMR400InstructionsforUse

Toenternormalmode

PresstheMainScreenkey.

AnyopenmenuwillcloseandanyhighlightedVSboxwillbedeselected(thatis,thenormalscreen

willbedisplayed).Seepage2‐14foranillustration.

Suspend Mode

WARNING

Suspend mode should never be used to silence alarms or when a patient is being actively

monitored as a delay in treatment and possible patient injury could result.

Suspendmodesupportspatient‐clinicianinteractionwithoutnuisancealarms,whichisuseful

whereminimaluserinteractionisrequired(forexample,whileapatientisnotbeingmonitored,

duringtransitionswhenremovingthemonitorfromonepatientandconnectingitonanother,or

ifcertainadjustmentsarebeingmadetothedeviceorotherequipment).

Insuspendmode,currentpatientinformationisprovided,butwiththefollowingoperational

exceptions:

•Audiblealarmsaredisabled;

•ActiveautomaticNIBPmeasurementsaresuspended;

•DefaultinflationpressuresareusedforallmanualNIBPreadings;and,

•IfequippedwithanIP5andprinter,automaticprintoutswillnotbegenerated.

Toentersuspendmode

PresstheSuspendkey.

Suspendedwillbedisplayedatthecenterofthescreen.Seepage2‐20foranillustration.

Toexitsuspendmode

PresstheSuspendkey.

Simulation Mode

Simulationmode,apasswordprotectedfunction,supportstrainingandtestingneedsby

displayinginternally‐generateddataforvitalsignwaveforms,numericvaluesandstatuses.In

simulationmode,allpatientmonitoringisdiscontinued.Seepage3‐29formenudetails.

CHAPTER 3

Getting Started

Initialsetupisimportanttoachieveexpectedresultsandseamlessoperation.

WARNINGS

•Perform operational verification prior to use. If the MR400 fails to function properly,

remove it from use and contact technical support personnel.

• Do not allow the patient to move while the MR400 is being used as over-activity may

result in prolonged or inaccurate readings.

• Position of the accessories may affect measurement accuracy. Always consult a

physician for interpretation of measurements provided by the MR400.

• Do not operate the MR400 outside the specifications indicated in Appendix A as it will

cause inaccurate results.

CAUTIONS

• A minor but noticeable degradation in wireless module communications may occur in the

presence of high-powered radios.

• Prior to clinical use, the user must be aware of the minimum distance from the MR magnet

that must be maintained for proper operation; see Positioning the MR400 on page 3-2 for

details.

Defibrillator and Electrosurgical Use

TheMR400hasadefibrillation‐proofdegreeofprotectionthatallowsapatienttobedefibrillated

whileconnectedtothewECGmoduleandleads.Whenusingadefibrillator,followallprecautions

relatedtoboththeMR400andthedefibrillatorequipment.Duringadefibrillationprocedure,the

ECGwaveformwillsaturatethenrecoverinlessthan5secondsinaccordancewithAAMI/ANSI

EC13andIEC60601‐2‐27.

3‐2GettingStartedExpressionMR400InstructionsforUse

WARNINGS

•The patient connector inputs for all parameters are protected against the use of a

defibrillator by internal circuitry when the recommended patient cables or accessories

are used.

• Defibrillation and electrosurgery: Do not touch the patient, or table, or instruments,

during defibrillation. This equipment does not provide protection against burning of

the patient.

• The MR400 can be used in the presence of defibrillators or electrosurgery units,

provided the equipment being used is in good working order, meets appropriate safety

standards, is properly grounded and is operated correctly in the appropriate manner

and environment. Improperly grounded equipment can be a safety hazard and can

also cause interference to the ECG signal and result in a noisy ECG signal waveform

and inaccurate heart rate measurements.

• Electrosurgical unit overloads may cause damage to this device.

• To minimize risk of damage to the MR400 during defibrillation, use only the

manufacturer’s specified accessories and supplies.

• This equipment does not meet electrosurgical interference suppression (ESIS)

requirements as stated in EC13, sub clause 4.2.9.14, as the ECG trace will temporarily

disappear from the display during cut or coagulation bursts.

CAUTION

When using a defibrillator, do not introduce discharges of 360 joules or more, repeated five times

over 5 minutes. Read the safety instructions provided with the defibrillator. The MR400 cart is

designed to withstand defibrillation and will recover within 5 seconds (per IEC 60601-1,

Requirements for the Safety of Medical Electrical Equipment, and IEC 60601-2-49, Particular

requirements for the basic safety and essential performance of multifunction patient monitoring

equipment).

Positioning the MR400

Duringuse,stationthecartatasafemonitoringdistanceintheMR

magnetroomthenpressdownoneachwheellocktoengageit.(When

thecartneedstobemoved,raiseeachwheellockbeforeproceeding).

UsetheguidehandletomoveandpositiontheMR400.Alwaysplacethe

MR400sothatyourviewofthescreenandalarmlightwillremainunobstructedduringuse.

CAUTION

Never lean against or apply excessive force to the guide handle.

WhenpositioningtheMR400foruse,observethefollowingwarningandcautions:

Warning

WARNING

.The MR400 shall meet its full function and performance specifications when

positioned in the MR room of a 3T magnet, up to the 5000 gauss line, 4W/kg

SAR, and 7.2 µT B1rms in all orientations. Always secure the MR400’s wheel

locks when the unit is placed within the MR system room. Failure to properly

position the MR400 and its accessories in the MR system room will result in

system or accessory failure, and possible patient or user injury.

CAUTIONS

• If the MR400 rolls to the face of the MR system due to magnetically induced pull force, do

not attempt to dislodge the MR400 by pulling from the display panel or guide handle;

instead, dislodge the MR400 by gently pulling from the lowest point of the base. This will

prevent the base of the unit from experiencing higher MR pull forces in the vertical

direction.

• Position the MR400 in a manner which does not block access to the device or wall plug

connectors.

• Field strength variations in a particular MR system room (which may be due to active

shielding technology, manufacturer variability, future enhancements, etc.) can make

distinguishing the 5,000 gauss level (as measured from the center line of the MR bore)

difficult. These variations may require moving the MR400 away from the MR system if

system abnormalities or malfunctions are observed. Prior to clinical use, ensure that the

allowable distance of the MR400 from the MR system is maintained for proper operation.

Operating the MR400

SAFETYAWARENESS

Warning

WARNING

Do not start up the product unless you and all other users present have read, fully

understood and know all the safety information and emergency procedures given in the

Safety section of this Instructions for Use. Operation of the product without having read,

understood and knowing ALL the safety information and procedures in the SAFETY section

could lead to fatal or other serious personal injury. It could also lead to clinical mis-diagnosis

or clinical mistreatment.

3‐4GettingStartedExpressionMR400InstructionsforUse

FollowthestepsbelowwhenoperatingtheMR400.

System Power-up and Communications Verification

Warning

WARNING

Always perform operational verification prior to use and during monitoring by ensuring

proper communications between the MR400, the wireless modules and IP5 (if equipped).

Failure to ensure proper communications can result in the loss of patient monitoring and the

loss of data transfer in networked systems equipped with an IP5. If a device fails to function

properly, remove it from use and contact technical support.

TheMR400reachesanoperationalstatewithin60secondsafterpower‐upandattainsfull

measurementaccuracyaccordingtotheequippedoptions:

• Afterapproximately2minuteswhenequippedwiththeCO2LoFlooption

• Afterapproximately10minutesifequippedwiththeAGENToption.

Whenanydisplayedwarm‐upmessagedisappears,theMR400isreadyforuse.

ToapplypowertotheMR400andverifysystemcommunications

Step Action

1Pressthepowerswitch;seepage2‐7forthelocation.

2EnsurethatthewECGandwSpO2modules(andIP5,ifequipped)

haveestablishedgoodcommunications,andthatsufficientpower

existsfortheMR400andthewirelessmodules.Alsoverifyproper

operationofthepatientparameters.

SeeSystemPower‐upandCommunicationsVerification,below.

Step Action

1EnsurethatbatteriesareinstalledinthewECGmodule(seepage1‐

24).

2CheckthebatteryindicatorsonthewECGmoduletoensurethat

enoughchargeexistsinatleastoneoftheinstalledbatteries:

• Greenbatteryindicator=Chargesufficient;proceedtostep4.

•Redbatteryindicator=Chargelow;proceedtostep3.

Seepage2‐9fordetails.(Also,youcanreferencethestatus

informationpane;seepage2‐16.)

3 Accordingtotheredbatteryindicator(s)presentonthewECG

module,insertachargedmodulebatteryintothecorresponding

batterybay(s)andthenrecheckthebatteryindicator(s)toensurea

sufficientchargebeforeproceeding;seepage1‐24.

4EnsurethatbatteriesareinstalledinthewSpO2module(seepage

1‐26).

5CheckthebatteryindicatoronthewSpO2moduletoensurethat

enoughchargeexists:

• Greenbatteryindicator=Chargesufficient;proceedtostep7.

•Redbatteryindicator=Chargelow;proceedtostep6.

Seepage2‐11fordetails.(Also,youcanreferencethestatus

informationpane;seepage2‐16.)

6InsertachargedmodulebatteryintothewSpO2moduleandthen

recheckthebatteryindicatortoensureasufficientchargebefore

proceeding;seepage1‐26.

7WiththecartbatteriesinstalledandwiththeMR400connectedto

ACmainspower(seepage1‐20),pressthepowerswitch.Allowthe

MR400toinitialize.

8(Optional)Ifequipped,turnontheIP5.

9CheckthenetworkchannelindicatoronthewECGmoduleto

ensurecommunicationisestablishedwiththeMR400:

• Steady=Goodcommunication;proceedtostep11.

• Flashing=Nocommunication;proceedtostep10.

Seepage2‐9fordetails.(Also,youcanreferencethestatus

informationpane;seepage2‐16.)AninoperativeECGparameteror

wECGmoduleisindicatedbyabsenceofanECGwaveformanda

simultaneousLeadFailalarm.

10 EnsurethatthewECGmoduleiswithin9.1m(30feet)ofthe

MR400,inthesameMRIroomorinthesameshieldedroom,andis

settothesamewirelessnetworkchannelusedbytheMR400;see

page1‐29.

11 CheckthenetworkchannelindicatoronthewSpO2moduleto

ensurecommunicationisestablishedwiththeMR400:

• Steady=Goodcommunication;proceedtostep13.

• Flashing=Nocommunication;proceedtostep12.

Seepage2‐11fordetails.(Also,youcanreferencethestatus

informationpane;seepage2‐16.)

12 EnsurethatthewSpO2moduleiswithin9.1m(30feet)ofthe

MR400,inthesameMRIroomorinthesameshieldedroom,andis

settothesamewirelessnetworkchannelusedbytheMR400;see

page1‐29.

13 (Optional)IfequippedwithanIP5,ensurethatthewireless

networkchanneloftheIP5isthesameasthewirelessnetwork

channelsettingoftheMR400;seetheIP5IFUfordetails.

Step Action

3‐6GettingStartedExpressionMR400InstructionsforUse

CAUTION

If power to the wireless device with established communications is lost or removed, its network

connection will be dropped.

Cart Power-down

ToturnpowerofftotheMR400,pressthenholdthepowerswitchforapproximately2seconds.

NOTE

For instructions on the complete removal of power to the MR400, see page 14-2.

Wireless Module Power-down

Toturnpowerofftoawirelessmodule,removethebattery(wSpO2module)orbatteries(wECG

module).

Monitor Initialization

Afterpower‐upanduntiltheinitializationprocesscompletes,thetouchscreenmayremain

blank.Afterinitializationcompletes,theMR400canbeginmonitoringfunctionsfromaninitial

factorydefaultstateorfromapre‐configuredstate,dependinguponthewaythestored

configurationsandpatientdataareprogrammedforstartup.

Visuallycheckingthepatientandconfirmingchangingmeasurementsagainstothervitalsigns

shouldbestandardroutinesduringuse.

14 (Optional)IfequippedwithanIP5,ensuregoodcommunication

betweentheMR400andtheIP5bycheckingthestatusinformation

pane(seepage2‐16).

15 Ensureproperoperationofeachpatientparameterandalarms.

Refertoappropriatechaptersinthismanual.

Step Action

Warning

WARNING

When using an IP5, make sure that the content of the User Settings option matches that of

the MR400 option, and that the same option is selected as the default setup on both systems

(see page 3-26). This is important because the device first booted will determine the power-

on settings of the system (that is, the MR400 and optional IP5).

Viewing the Displayed Information

ThehighresolutiontouchscreenLCDfacilitateswaveformanalysisandvitalsignnumeric

interpretation,withimportantdisplayelementswhicharedesignedtobelegibleataminimum

distanceof1meterbyuserswithavisualacuityof20/20.WhenusingtheMR400,alwaysadjust

theviewingangleofthetouchscreentocomplementyourlineofsightandalwaysensurethat

yourviewremainsunobstructed.

CAUTION

Never apply unnecessary force to the touch screen as it can result in damage or failure.

NOTE

To change the language displayed by the MR400, see System Config page 3-30.

Default Settings

Atpowerup,theMR400willautomaticallysetallmonitorsetupoptionsasdeterminedbythe

defaultselectionintheEditUserSettingsmenu.Bydefault,thefactorysettingsareusedwhen

thesystemisturnedon,unlessacustomsettinghasbeenselected.Also,asdiscussedearlier,due

totheusemodel,thepower‐ondefaultsettingsfortheMR400candependupona

communicatingIP5andthestart‐upsequenceofthedevices.

Default Setting Indications

TheUserSettingskeyindicatesthecurrentdefaultsetup(wheretheplussymbol[+]indicates

thatchangeshaveoccurred)anditallowsyoutoselectafactoryorastoredusersetup;seepage

2‐14.

Whenamenuisdisplayed,thedefaultwillbehighlightedorwillappearwithanasterisk.Forthe

factorydefaultsettings,seethemenulistingsthroughoutthisIFU.

3‐8GettingStartedExpressionMR400InstructionsforUse

User Settings

IntheEditUserSettingsmenu,uptotencustomizedusersettingscanbesavedandonecanbe

selectedforuseasthedefaultatpower‐on.Usersettingscanincludeanyofthefollowingmenu

options:

•Alarms

–Minimumandmaximumvalues

–Auto‐setpercentage

–Alarmsoundlevel

– ExtremeHRalarmvalues

–Desat

alarmvalues

• SystemSetups

•ECG

– Selectedlead

–Scalesetting

–Tracespeed

– Filtermode

–QRStoneon/off

–Heartratesource

– PediatricECGon/off

– ExtremeHRalarmfunctionsetting

•SpO2



–Size

–Desatalarmfunctionsettings

•CO2

–Size

–Grids

•CO2(RESP)

–Apneaalarmfunctionsettings

•NIBP

–Manual

–OfforAuto

–Automatictimeinterval

•Trendgraphs

–Timebases

–Scales

•PrintSetups

–OfforAuto

–Tracedelay

– Printerspeed

– Selectedtraces

NOTE

When a setting is changed in an active user settings file, a plus sign (+) will appear on the User

Settings key. And when edits have been made to an existing user settings file, a warning box and

setting change list will appear, prompting you to accept or cancel the changes to proceed.

SoftKeyboard—AddNew

Namescanbeassignedtoyourusersettingsfilesusingthesoftkeyboardthatisdisplayedwhen

theAddNewoptionisselected;seepage3‐15.Thissoftkeyboard(seeillustrationbelow)

functionslikestandardQWERTYkeyboard,butwithadditionalfeaturesfordatacapturesand

defaultsettingselection.

SoftKeyboard—EditExisting

Existingusersettingsfilescanbeeditedusingthesoftkeyboardthatisdisplayedwhenastored

fileisselected;seepage3‐15.Thefilenameanddatacontentscanbechanged,andthedefault

settingcanbeupdated.Theillustrationbelowhighlightstheseadditionalfilemanagement

featuresofthesoftkeyboard.

1Save & Close button assigns the captured settings to the

entered file name then saves the file in memory and closes the

menu.

2 Capture Settings button saves the current settings data of the

MR400.

3 Set To Default button selects the settings of the current entry

for use following power-up of the MR400.

4Entry field displays the currently entered file name for the

captured user settings.

3‐10GettingStartedExpressionMR400InstructionsforUse

Initial Alarm Indications

Afterpower‐upandimmediatelyfollowingtherecallofastoredsetup,theMR400providesan

indicationofthealarmvolumebysoundingthealarmtoneatitscurrentlyadjustedsettingfor5

secondsanddisplayingCheckAlarmVolume.

Afterpower‐up,theinitialalarmstateispausedandthen,followingawaitperiodof120seconds,

armedbecomesthenormalalarmstate(asindicatedbythedisplayedsymbol,showninthetable

below):

Inthearmedstate:

•Analarmwillsoundwhileanalarmconditionexists,providedthatanypre‐alarmwait

periodhasexpiredandthealarmaudioarmedsymbolisdisplayed.

1 Remove as Default button removes the file as the default user

settings file

2 Delete Settings button deletes the file.

Displayed Symbol Alarm Sound State

Alarm audio armed

Alarm audio paused

Alarm audio off

•Alarmflagsrelatedtootheralarmsoundstateswillberemovedfromthedisplay.

•Analarmconditionnotpreviouslyplacedinanaudiooffstatewillcausethealarmto

sound.

Selecting the Patient Type

DeterminingthePatientType

IEC80601‐2‐30Edition1.0,theinternationalstandardregardingparticularrequirementsfor

safety,includingessentialperformanceofautomaticcyclingnon‐invasivebloodpressure

monitoringequipment,definespatienttypesintwocategories:neonatalandadult.Neonatal

patientsaredefinedbytheapproximateagerangeofbirthtoafewweeks.Allotherpatientsare

identifiedasadults.

ANSI/AAMISP10:2008,theAmericanNationalStandardformanual,electronic,orautomated

sphygmomanometers,definespatienttypesaccordingtoagelimitations,asindicatedinthetable

below.

Similarly,theFood&DrugAdministrationdefinespatientswithintwocategories:pediatricsand

adults.Eachcategoryisfurtherdefinedintosubgroupsaccordingtoapproximateage.

CAUTION

There may be occasions when a particular mode is not suitable for its apparent category of patients

based on age alone. In these cases, a clinical decision shall be made to use another patient type or

measurement technique. The clinical decision shall be based on all of the factors listed in

Determining the Patient Type (above) to ensure the best possible and most timely measurement

acquisitions.

Patient Type Age

Neonatal Birth to 28 days

Pediatric 29 days to 12 years

Adult Greater than 12 years

Patient Type Subgroup Approximate Age Range

Pediatric Newborn (neonate) Birth to 1 month

Pediatric Infant Greater than 1 month to 2 years

Pediatric Child Greater than 2 to 12 years

Pediatric Adolescent Greater than 12 to 21 years

Adult --- Greater than 21 years

3‐12GettingStartedExpressionMR400InstructionsforUse

Regardlessofthedefinition,eachagencyrecognizesthatthepatienttypedescriptionscanbe

arbitraryandthatthefollowingpatientfactorsaremoreaccurateindeterminingtheappropriate

methodofpatientmonitoringandtreatment:

–Weight

–Bodysize

–Limbcircumference

– Physiologicaldevelopment

–Neurologicaldevelopment

– Neuromuscularcoordination

Accordingly,theMR400usesseveraloperationalparameters,includingcuffinflationpressure

andpulsesensitivity,thatvarydependingontheselectedpatienttype.(Alwaysreferto

informationaboutthecorrespondingparameterforotherpossibleconsiderationswhen

determiningthepatienttype.)

ThePatientTypekeyallowsyoutosettheMR400forthetypeofpatienttobemonitored.

ToopenthePatientTypemenu

PressthePatientTypekey.

Thefollowingpatienttypesareavailable:

•Adult(Default)

• Pediatric

Patient Type key

Patient Type menu

•Neo(whenselected,PediatricECGwillalsobesettoOn)

NOTE

Changing the Patient Type causes the alarm to sound, Change NIBP Cuff to be displayed for 30

seconds, the initial cuff inflation to be reset to the initial pressure for the patient type selected,

NIBP > Auto Mode to be set to off, and the alarm limit settings to revert to the default values24).

Toselectthepatienttype

Setup Menus

PressingtheSetupkeywilldisplaytheMonitor,Printer,and

Alarmskeys.

TheMonitor,Printer,andAlarmskeysopenassociated

menusforsetupandcontrol,including:

•Savingandrecallingsetupconfigurations

• Controllingparameters

• Adjustingsounds

• Switchingpatienttypes

• Settingtimeanddate

Step Action

1PressthePatientTypekey.(Thecurrentsettingisdisplayed.)

ThePatientTypemenuappears.Thecurrentsettingishighlighted.

2 SelectthePatientType:

Adult

Pediatric

Neo

Thesettingisentered.

1 Setup key

2 Monitor key

3Printer key

4Alarms key

3‐14GettingStartedExpressionMR400InstructionsforUse

• Settingsweepspeeds

• ControllingECGmodes

• Controllingalarms

• Controllingremoteprinting

Warning

WARNING

When using an IP5, wait at least 4 seconds if performing a recall or setting a parameter

value, as these require a few seconds to propagate through the system. Performing another

recall within 4 seconds of a previous recall or after a value change, may result in improperly

recalled data.

NOTE

Grayed out items in the menu system, indicate features or options that are inaccessible due to

current settings, or that are not configured or installed.

Monitor Setup Menu

TheMonitorSetupmenuallowsyoutoconfiguretheMR400forpatientmonitoring.

ToopentheMonitorSetupmenu

PresstheSetupkeyandthentheMonitorkey.

Setup key

Monitor Setup menu

Monitor key

ThefollowingMonitorSetupmenuitemsareavailable:

TochangesettingsintheMonitorSetupmenu

Edit User Settings

Allowsyoutocapture,storeandmanagemultipleusersetups,andtoselectanoperationalor

power‐updefaultsetup.Abackupandrestoreselectionalsoallowsyoutosavetheseuser

settingstoanexternaldevice.

ToopentheEditUserSettingsmenu

•Edit User Settings

• Parameters

• Sound Adjust

•Set Time & Date

• Sweep Speed

• Resp Speed

• Service(Bio-Med)

Step Action

1PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

2 Selectanyofthefollowingmenuitems:

EditUserSettings

Parameters

SoundAdjust

SetTime&Date

SweepSpeed

RespSpeed

Service(Bio‐Med)

Theselectedmenuappears.Currentsettingsaredisplayed.

3 Selectthedesiredmenuitem.

Thecurrentsettingishighlighted.

4 Selectthedesiredsub‐menuorsettingfromthemenuoptions.

Thesettingisentered.

5Tochangeothersettings,repeatsteps2,3and4.

3‐16GettingStartedExpressionMR400InstructionsforUse

PresstheSetupkeyandthentheMonitor

key.OntheMonitorSetupmenu,selectEdit

UserSettings.

Thefollowingoptionsareavailable:

•Factoryrecallsthefactorysettings

frommemory,whichcannotbemodified.(Default)

•AddNewallowsyoutoassignafilename,selectadefaultsetting,andstoreacurrent

setupinthememory(uptotensetupscanbestored);seepage3‐7formoreinformation.

•Backup/RestoreallowsyoutobackupandrestoresettingsusingaUSBflashdrive;seethe

servicemanual(REF989803181911)fordetails.

Toaddandsavenewusersettings

1Factory

2 Add New

3 Backup/Restore

Step Action

1 SetuptheMR400fortheconfigurationtowhichthesesettingswill

pertain.

2PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

3OntheMonitorSetupmenu,selectEditUserSettings.

TheEditUserSettingsmenuappears.

4 SelectAddNew.

Thesoftkeyboardappears.

5 Enterauniquefilename(ofuptotwentycharacters)fortheuser

settingsusingthesoftkeyboard.

6PresstheCaptureSettingsbuttontoenterthecurrentsetupdata.

Toeditsavedusersettings

Todeletesavedusersettings

7Ifdesired,presstheSettoDefaultbuttontosavethecurrentfileas

thedefaultsetupforuseatpower‐up.

Warning

WARNING

If you choose to boot the device from a user settings

file, confirm that alarm presets are appropriate for the

patient prior to monitoring. Failure to do so may cause

false or missed alarm conditions.

8PresstheSave&Closebuttontosavethecurrentsetupandexit

themenu.

Awarningboxwillappear,promptingyoutoacceptthechanges:

presstheAcceptbuttontosavethecurrentsettings,orpressthe

Cancelbuttontorejectthechanges.

Step Action

1ConfiguretheMR400forthedesiredsettings.

2OntheMonitorSetupmenu,selectEditUserSettings.

3 Selectthefilenamethatyouwanttochange.

4PresstheCaptureSettingsbuttontochangetheusersetuptothe

currentsettings.

5PresstheSave&Closebuttontosavethecurrentsetup.

Awarningboxwillappear,promptingyoutoacceptthechanges—

pressAccepttosavethecurrentsettingsorpressCanceltoreject

thechanges.

Step Action

1OntheMonitorSetupmenu,selectEditUserSettings.

2 Selectthefilenamethatyouwantdelete.

Step Action

3‐18GettingStartedExpressionMR400InstructionsforUse

Parameters

Controlsmonitoringfunctions,asindicatedbytheabsenceorpresenceoftheVSboxforthe

parameter,exceptECG(seebelow).

NOTE

Some parameters require optional equipment that may not be enabled or present on your system;

see System Config for details.

ToopentheParametersmenu

PresstheSetupkeyandthentheMonitor

key.OntheMonitorSetupmenu,select

Parameters.

Thefollowingparametersareavailable:

•ECGallowselectrocardiogrammonitoring:

–OffturnsofftheECGparameter.(Heartrate(HR)willremainintheVSbox,allowingit

tobedisplayedfromanothersourceorifHRSourceissettoAuto.)

3PresstheDeleteSettingskey.

4PresstheSave&Closebuttontosavethecurrentsetup.

Awarningboxwillappear,promptingyoutoacceptthechanges—

pressAccepttosavethecurrentsettingsorpressCanceltoreject

thechanges.

1ECG

2NIBP

3P1

4P2

5SPO2

6CO2

7RESP

8TEMP

9AGENT

Step Action

–OnturnsontheECGparameter.(Default)

•NIBPallowsnon‐invasivebloodpressuremonitoring(doesnothaveanassociated

waveform):

–OffturnsofftheNIBPparameter.

–OnturnsontheNIBPparameter.(Default)

•P1allowsinvasivebloodpressuremonitoring:

–OffturnsofftheP1parameter.(Default)

–OnturnsontheP1parameter.

•P2allowsinvasivebloodpressuremonitoring:

–OffturnsofftheP2parameter.(Default)

–OnturnsontheP2parameter.

•SPO2allowsoxygensaturationofarterialbloodmonitoring:

–OffturnsofftheSPO2parameter.

–OnturnsontheSPO2parameter.(Default)

•CO2allowsCO2andCO2‐derivedrespirationratemonitoring:

–OffturnsofftheCO2parameter.(Default)

–OnturnsontheCO2parameter.

NOTE

If CO2 is turned Off, AGENT and GAS will also be deactivated.

•RESPallowsrespirationratemonitoringusingthebellows(doesnothaveanassociated

waveform):

–Offturnsoffthebellows‐derivedrespirationparameter.(Default)

–Onturnsonthebellows‐derivedrespirationparameter.

NOTE

If CO2-derived respiration is on, then RESP will not be selectable. To use bellows respiration,

select BEL in the RESP menu; see page 10-5.

•TEMPallowstemperaturemonitoring(doesnothaveanassociatedwaveform):

–Offturnsoffthetemperatureparameter.(Default)

–Onturnsonthetemperatureparameter.

3‐20GettingStartedExpressionMR400InstructionsforUse

•AGENTallowsanestheticagentandgasmonitoring(butdoesnothaveanassociated

waveform),andCO2andCO2‐derivedrespirationratemonitoring:

–OffturnsofftheAGENTparameter.(Default)

–OnturnsontheAGENTparameter.

NOTE

When AGENT is turned on, CO2 will also be activated, including GAS; however, if AGENT is

then turned Off, CO2 will remain active.

Tocontrolparameters

Sound Adjust

Controlsalarm,heartrateandtouchscreentones,andthevolumesettingsforthesounds

generatedbytheMR400.

Warning

WARNING

The alarm sound can be turned off, as indicated by the symbol. Always ensure that the

alarm sound setting is appropriate for the monitoring environment and for each patient. The

alarm sound volume is adjustable for suitability to various clinical environments. When you

use the MR400, always ensure that the alarm sound can be heard above the ambient noise

level; otherwise, treatment of the patient could be delayed.

ToopentheSoundAdjustmenu

Step Action

1PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

2OntheMonitorSetupmenu,selectParameters.

TheParametersmenuappears.Currentsettingsaredisplayed.

3Locatetheparameterthatyouwanttocontrolthenselectthe

desiredsetting:

Off

Thesettingisentered.Tochangeothersettings,repeatstep3.

PresstheSetupkeyandthentheMonitor

key.OntheMonitorSetupmenu,select

SoundAdjust.

Thefollowingmenuitemsareavailable:

•Alarmscontrolsthealarmsound(identicaltoandinteractivewithAlarmSoundinthe

Alarmsmenu):

–Offturnsoffthealarmsound,asindicatedbythealarmaudiooffsymbol(seepage4‐

4).(Onlythealarmsoundwillbedisabled;visualalarmindicationswillcontinue.)

–Onturnsonthealarmsound,asindicatedbythealarmaudioarmedsymbol(see

page4‐4).(Default)

•HRToneSourcesetsthesourceusedfortheheartratetone(identicaltoandinteractive

withsameoptionintheECGmenuandSPO2menu):

–Offremovestheheartbeatdetectedsymbolfromthedisplayandsoundsnopulse

tone.(Default)

–QRSprovidestheheartbeatdetectedsymbolandatonetriggeredbytheQRS

detectionfromtheECGvitalsign.

–SPO2providestheheartbeatdetectedsymbolandatonemodulatedbytheSPO2

vitalsign,wherethelowertheSPO2value,thelowerthepitch.

•AlarmVolumesetsthealarmsoundlevelfrom1–10.(Default=4)

•PulseVolumesetsthepulsesoundlevelfrom1–10.(Default=4)

•ClickTonecontrolsanaudioindicationthatisproducedwhenanactiveareaofthetouch

screeniscontacted:

–Offdoesnotproduceaclicktone.

–Onproducesaclicktone.(Default)

•ClickVolumesetstheclicktonesoundlevelfrom1–10.(Default=4)

1Alarms

2 HR Tone Source

3 Alarm Volume

4Pulse Volume

5 Click Tone

6Click Volume

3‐22GettingStartedExpressionMR400InstructionsforUse

Tocontrolthesounds

Set Time & Date

Setsthetimeanddate,andthedisplayedtimeanddateformats;seepage2‐14.

ToopentheSetTime&Datemenu

Step Action

1PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

2OntheMonitorSetupmenu,selectSoundAdjust.

TheSoundAdjustmenuappears.Currentsettingsaredisplayed.

3 Selectthemenuitemforthesoundfunctionthatyouwantto

control:

Alarms

HRToneSource

AlarmVolume

PulseVolume

ClickTone

ClickVolume

Themenuitemappears.Thecurrentsettingishighlighted.

4 Selectthedesiredsettingfromthemenuoptions(exceptAlarms

andClickTone,whichareselectableontheSoundAdjustmenu.)

Thesettingisentered.

NOTE

When making adjustments to the volume settings, Real Tones

Disabled will be displayed and a momentary sound at the setting

level will be produced. To your save changes and close the menu

select .

5Tochangeothersettings,repeatsteps3and4.

PresstheSetupkeyandthentheMonitorkey.

OntheMonitorSetupmenu,selectSetTime

&Date.

Thefollowingmenuitemsareavailable:

•IPxTimeSyncsynchronizesthetimeanddatesettingsoftheMR400tothatofanIP5(IP5

optionrequired).

•TimeFormatchangestheformatofthedisplayed(andprinted)hours:minutes:seconds

(hh:mm:ss):

–12Hrusesthe12‐hour(hh)convention(01–12)withtheAMorPMdesignation.

–24Hrusesthe24‐hour(hh)convention(00–23).(Default)

•DateFormatchangestheformatofthedisplayed(andprinted)date:

– Month/Day/Year:Usesa<mm>/<dd>/<yyyy>format

– Day/Month/Year:Usesa<dd>/<mm>/<yyyy>format

–MonthDay,Year:Usesa<mname><dd>,<yyyy>format

•Secondscrollsthesecondcounter.

•Minutescrollstheminutecounter.

•Hourscrollsthehourcounter.

•Dayscrollsthedaycounter.

•Monthscrollsthemonthcounter.

•Yearscrollstheyearcounter.

Tosettheformatofthedisplayedtimeordate

1IPx Time Sync

2Time Format

3 Date Format

4Second

5 Minute

6Hour

7Day

8Month

9Year

Step Action

1PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

3‐24GettingStartedExpressionMR400InstructionsforUse

Tosetthetimeordate

2OntheMonitorSetupmenu,selectTimeandDate.

TheTimeandDatemenuappears.Currentsettingsaredisplayed.

3 Selectthemenuitemforthetimeordatefunctionthatyouwant

tochange:

TimeFormat

DateFormat

Themenuitemappears.Thecurrentsettingishighlighted.

4 Selectthedesiredsettingfromthemenuoptions.

Thesettingisentered.

5Tochangeothersettings,repeatsteps3and4.

Step Action

1PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

2OntheMonitorSetupmenu,selectTimeandDate.

TheTimeandDatemenuappears.Currentsettingsaredisplayed.

3Usethearrowkeysassociatedwitheachtimeordatefunctionthat

youwanttochange(leftarrowdecreasesthesetting,rightarrow

increasesthesetting):

Second

Minute

Hour

Day

Month

Year

Thesettingischanged.

4Toadjustothersettings,repeatstep3.

5Whenfinished,selectthecheckmark.

Thechangesaresavedandthedisplayedtimeisadjusted.

Step Action

Sweep Speed

Setsthesweeprateforallwaveforms(displayedandprinted),exceptCO2.

ToopentheSweepSpeedmenu

PresstheSetupkeyandthentheMonitor

key.OntheMonitorSetupmenu,select

SweepSpeed.

Thefollowingspeeds(inmillimetersper

second)areavailable:

•50mm/s

•25mm/s(Default)

Toadjustthesweeprateforallwaveforms(exceptCO2)

Resp Speed

SetsthesweepratefortheCO2waveform.

ToopentheRespSpeedmenu

1 50 mm/s

2 25 mm/s

Step Action

1PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

2OntheMonitorSetupmenu,selectSweepSpeed.

TheSweepSpeedmenuappears.Thecurrentsettingishighlighted.

3 Selectthedesiredsettingfromthemenuoptions:

50mm/s

25mm/s

Thesettingisentered.

3‐26GettingStartedExpressionMR400InstructionsforUse

PresstheSetupkeyandthentheMonitor

key.OntheMonitorSetupmenu,selectResp

Speed.

Thefollowingspeeds(inmillimetersper

second)areavailable:

•25mm/s

•12.5mm/s(Default)

•6.25mm/s

•3.125mm/s

ToadjustthesweepratefortheCO2waveform

Service(Bio-Med)

Accessesasub‐menuthatcontainssoftwareandfirmwareinformationaboutthesystem,and

optionsforNIBPandP1(andP2)pressures,diagnosticsandconfiguration.

ToopentheService(Bio‐Med)menu

1 25 mm/s

2 12.5 mm/s

3 6.25 mm/s

4 3.125 mm/s

Step Action

1PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

2OntheMonitorSetupmenu,selectRespSpeed.

TheRespSpeedmenuappears.Thecurrentsettingishighlighted.

3 Selectthedesiredsettingfromthemenuoptions:

25mm/s

12.5mm/s

6.25mm/s

3.125mm/s

Thesettingisentered.

PresstheSetupkeyandthentheMonitor

key.OntheMonitorSetupmenu,select

Service(Bio‐Med).

NOTE

Some menu items require entry of a password for access; see page 2-23.

ToaccesstheSERVICE(BIO‐MED)menuitems

1 Revision Information

2 Simulation Mode

3Gas Cal

4 System Config

5ECG Tests

6NIBP Tests

7 Backlight Brightness

8 Service Utilities

Step Action

1PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

2OntheMonitorSetupmenu,selectService(Bio‐Med).

TheService(Bio‐Med)sub‐menuappears.

3 Selectthedesiredmenuitem(somemenusarepassword

protected):

RevisionInformation

SimulationMode

GasCal

SystemConfig

ECGTests

NIBPTests

BacklightBrightness

ServiceUtilities

Theselectionisentered(orenterthecorrectpasswordforaccess).

4 Selectthedesiredmenuoritem,exceptSimulationMode,whichis

selectableontheService(Bio‐Med)menu.

Thesettingisentered.

3‐28GettingStartedExpressionMR400InstructionsforUse

Revision Information

Dependingupontheinstalledoptions,displaysrevisioninformationforthesoftwareand

firmwareusedintheMR400andwirelessmodules.

Toviewtherevisioninformation

PresstheSetupkeyandthenthe

Monitorkey.OntheMonitorSetup

menu,selectService(Bio‐Med).Onthe

Service(Bio‐Med)menu,selectRevision

Information.

ThedefinitionsfortheitemsdisplayedinRevisionInformationareprovidedbelow.

5Tochangeothersettings,repeatsteps2,3and4.

1WECG SW:

2WECG SW CHKSUM:

3WECG FW:

4IOP SW:

5FPGA FW:

6Cart SW:

7TEMP FW:

8GAS FW:

9PICO NIBP SW:

NameDefinition

WECGSW SoftwarerevisionofthewECGmodule

WECGSWCHKSUM ChecksumofthesoftwareofthewECGmodule

WECGFW FirmwarerevisionofthewECGmodule

IOPSW Softwarerevisionoftheinput/outputprocessor

FPGAFW SoftwarerevisionoftheprocessingelementoftheMR400

CartSW SoftwarerevisionoftheMR400cart

TEMPFW FirmwarerevisionofTEMPsystem

GASSW Softwarerevisionofgassystem

PICONIBPSW SoftwarerevisionoftheNIBPsystem

Step Action

Simulation Mode

Warning

WARNING

The MR400 is equipped with a simulation mode that displays computer generated data for

training or demonstration. As a safety feature, Simulation is displayed and appears on all

printouts while in simulation mode. Do not attach a patient to the MR400 when in simulation

mode and never activate simulation mode when a patient is connected. The MR400 will not

monitor patients while in the simulation mode. Activating simulation mode when a patient is

connected will result in a lapse in patient monitoring and could result in a delay in

treatment.

AllowstheMR400tooperateusinginternally‐

generateddatainsteadofpatientdata.

ToopentheSimulationModemenu

PresstheSetupkeyandthentheMonitorkey.On

theMonitorSetupmenu,selectService(Bio‐Med).

OntheService(Bio‐Med)menu,locateSimulation

ModeandselectOn.Enterthepassword.

Thefollowingcontrolsareavailable:

•Offdisplaysnormalmonitoringfunctions.

(Default)

•Ondisplayssimulationsofmonitoring

functions.

Toentersimulationmode

Toexitsimulationmode,turnoffthepowerswitch.

Step Action

1EnsurethatnopatientisconnectedtotheMR400.

2PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

3OntheMonitorSetupmenu,selectService(Bio‐Med).

TheService(Bio‐Med)menuappears.Currentsettingsare

displayed.

4LocateSimulationModeandselectOn.

5WhenEnterPasswordisdisplayed,enterthecorrectsix‐digitcode.

Simulationwillbedisplayedinthesystemmessageareaofthe

simulatedscreen.

3‐30GettingStartedExpressionMR400InstructionsforUse

Gas Cal

Calibratesthegasfunction(s)whenequippedwiththeCO2ortheAGENToption.

NOTE

As indicated by displayed message, allow any warm-up to complete before calibrating.

ToopentheGasCalmenu

PresstheSetupkeyandthenthe

Monitorkey.OntheMonitorSetup

menu,selectService(Bio‐Med).Onthe

Service(Bio‐Med)menu,selectGas

Cal.

Thefollowingmenuitemsare

available:

•ZeroCalInitiatesazero

calibration(afunctionthat

occursautomaticallyduringnormaluse).ForLoFloCO2optiondetails,seepage7‐2;and

fortheAGENToptiondetails,seepage9‐2.

•O2Calperformsa1‐minutepressurecalibrationoftheO2sensorfortheAGENToption.

Connectionofasamplelineisrequiredforthistest.

•CO2AccuracyCheckteststheLoFloCO2accuracy(a5%gassourcemustbeconnectedto

theMR400).ProvidesaCO2waveformvalue(asapercentage),anatmosphericpressure

readingandanumericCO2value(inmmHg).

NOTE

During the CO2 Accuracy Check, to alert you that the indicated values are not actual patient

measurements, the following message will be displayed: CO2 test in progress. Do not use CO2

values for patient monitoring during test. Pressing close will cancel test.

System Config

ControlstheconfigurationoftheMR400includingoptions,languageandunitofmeasurement

forpressures.

1Zero Cal

2O2 Cal

3 CO2 Accuracy Check

ToopentheSystemConfigmenu

PresstheSetupkeyandthenthe

Monitorkey.OntheMonitorSetup

menu,selectService(Bio‐Med).Onthe

Service(Bio‐Med)menu,selectSystem

Config.

Thefollowingmenuitemsareavailable:

•ECG1configurestheMR400forECG1

•ECG2configurestheMR400forECG2

•NIBPconfigurestheMR400forNIBP

•P1configurestheMR400forP1

•P2configurestheMR400forP2

•SPO2configurestheMR400forSPO2

•GasBenchconfigurestheMR400forthegasbenchoption,whereCO2onlyselectsthe

CO2Loflooption,AgentsselectstheAGENToption

•RESPsetstheconfigurationoftheunitforbellows‐derivedRESP

•TEMPconfigurestheMR400forTEMP

•Languagesetsthelanguageforthedisplayedinformation:

– English(Default)

–Deutsch

–Espanol

– Francais

1ECG 1

2ECG 2

3NIBP

4P1

5P2

6SPO2

7Gas Bench

8RESP

9TEMP

10 Language

11 ECG Notch Filter

12 Pressure Units

13 Gas Units

3‐32GettingStartedExpressionMR400InstructionsforUse

–Portuguese

– Italiano

–Dansk

–Svenska

–Norsk

–NLD

•ECGNotchFilterappliesanotchfiltertotheECGsignal:

–Off

–50Hz

–60Hz(Default)

•PressureUnitssetstheunitofmeasureforP1,P2,andNIBPpressurereadings:

–mmHg(Default)

–kPa

•GasUnitssetstheunitofmeasureforCO2pressurereadings:

–mmHg(Default)

–kPa

ECG Tests

AccessestestingfunctionsforECG.

ToopentheECGTestsmenu

PresstheSetupkeyandthenthe

Monitorkey.OntheMonitorSetup

menu,selectService(Bio‐Med).Onthe

Service(Bio‐Med)menu,selectECG

Tests.

Thefollowingmenuitemsare

available:

•ECGTestSignalcontrolsawECG

module‐generated1mVpeak‐

to‐peaksquarewave,where60

BPMwillbedisplayedintheECG

VSboxandECGTestSignalwillbedisplayedinthealarmflagarea(andprintedwhen

outputtotheprinter,ifequipped):

–Offdoesnottransmitthetestsignal.(Default)

–Ontransmitsthetestsignal.

1ECG Signal Test

NOTE

ECG Test Signal is unavailable when Filter Mode > Advanced 2 is selected; see 5-31.

TocontroltheECGTestSignal

NIBP Tests

AccessescalibrationandtestingfunctionsforNIBP.

NOTE

If Module Not Calibrated is displayed, then all options in the NIBP Tests menu will be locked

until NIBP is successfully calibrated.

ToopentheNIBPTestsmenu

Step Action

1EnsurethatthewECGmoduleiscommunicatingwiththeMR400.

2PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

3OntheMonitorSetupmenu,selectService(Bio‐Med).

TheService(Bio‐Med)menuappears.Currentsettingsare

displayed.

4LocateECGTestSignalandselectthedesiredsetting:

Off

Thesettingisentered.

3‐34GettingStartedExpressionMR400InstructionsforUse

PresstheSetupkeyandthenthe

Monitorkey.OntheMonitorSetup

menu,selectService(Bio‐Med).Onthe

Service(Bio‐Med)menu,selectNIBP

Tests.

Thefollowingmenuitemsare

available:

•CalibrateperformscalibrationoftheNIBPsystem.(Passwordrequired)

•StaticTestperformsastaticpressuretestoftheNIBPsystem.(Passwordrequired)

•LeakTestperformsapressureleaktestoftheNIBPsystem(seenotebelow).

•StressTestperformsapressurestresstestoftheNIBPsystem.(Passwordrequired)

•HighRangeCheckperformsahighpressuretestoftheNIBPsystem.(Passwordrequired)

NOTE

If an error is reported while the Leak Test is in progress, the test will be canceled and user will be

prompted with the message: NIBP Bench Error. Press Start to try again.

Toperformthesetests

Seereferencetheservicemanualfordetails.

Backlight Brightness

Adjuststhebrightnessofthetouchscreen.

ToopentheBacklightBrightnessmenu

1 Calibrate

2 Static Test

3 Leak Test

4 Stress Test

5 High Range Check

PresstheSetupkeyandthentheMonitor

key.OntheMonitorSetupmenu,select

Service(Bio‐Med).OntheService(Bio‐Med)

menu,selectBacklightBrightness.

Thefollowingbrightnesslevelsareavailable:

•1(Minimum)

•2

•3

•4

•5

•6(Default)

•7

•8(Maximum)

Tocontrolthebrightnessofthedisplaybacklight

Service Utilities

Accessesservice‐relatedfunctions(apasswordisrequiredforaccess).

ToopentheServiceUtilitiesoption

Step Action

1PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

2OntheMonitorSetupmenu,selectService(Bio‐Med).

TheService(Bio‐Med)menuappears.Currentsettingsare

displayed.

3 SelectBacklightBrightnessandthenenterthedesiredbrightness

level:

1–8

Thesettingisentered.

3‐36GettingStartedExpressionMR400InstructionsforUse

PresstheSetupkeyandthenthe

Monitorkey.OntheMonitorSetup

menu,selectService(Bio‐Med).Onthe

Service(Bio‐Med)menu,selectService

Utilities.Enterthepassword.

Thefollowingmenuitemsareavailable:

•NIBPDiagnosticsopensawindowthatdisplaysNIBPdiagnosticdata.

•CO2DiagnosticsopensawindowthatdisplaysCO2diagnosticdata.

1NIBP Diagnostics

2CO2 Diagnostics

3 Radio Diagnostics

•RadioDiagnosticsopensawindowthatdisplaysradiodiagnosticdata.

3‐38GettingStartedExpressionMR400InstructionsforUse

CHAPTER 4

Alarms

Thealarminformationhereappliestoallmeasurements.Measurement‐specificalarm

informationisdiscussedinthesectionsonindividualmeasurements.Themonitorprovides

patientalarmsandINOPalarms.

PatientAlarms

Patientalarmswillilluminatearedoryellowalarmlight,wherearedalarmlightindicatesahigh

priorityalarmtoalertyoutopotentiallylifethreateningsituationsforyourpatient(forexample,

adisconnectedcatheter).Ayellowalarmlightindicatesalowerprioritypatientalarm(for

example,arespirationalarmlimitviolation).

Patientalarmsmayalsogenerateflashingnumericvaluesorotherindications,alarmflagsand

soundanaudiblealarm(providedthatahigherpriorityalarmsounddoesnotoverrideit).

Forexample,ifapatient’sheartrateclimbsto71BPM(whichisabovethesettingoftheupper

alarmlimit)aphysiologicalalarmconditionisdeclared.

INOPs

INOPsarestatusandtechnicalalarms—theyindicatethatthemonitorcannotmeasureordetect

alarmconditionsreliably;seepage4‐31foralisting.Dependinguponthenatureofthecondition

detected,INOPswillilluminatethealarmlight,generateanalarmflag,andsoundanaudible

indicatortone(providedthatahigherpriorityalarmsounddoesnotoverrideit).Otherstatus

andtechnicalalarmshaveamediumorhighprioritydependinguponthenatureofthecondition

detected.

MultipleAlarms

Patientalarmsaremutuallyexclusiveandthehighestpriorityalarmwillbeindicatedbythealarm

light;ifahighpriorityalarmandamediumpriorityalarmarepresentsimultaneously.thered

alarmlightwillbeon,buttheyellowalarmlightwillnotbe.

1Medium priority alarm example (ECG heart rate value)

2Violated (high) alarm limit setting

4‐2AlarmsExpressionMR400InstructionsforUse

Thebluealarmlightcanbeonatthesametimeastheredoryellowalarmlight.Whenanumeric

valuebecomesmissingduetoanINOP,theINOPalarmwillbepresentaswellasthepatient

alarm(duetothemissingvalue),withbothoriginatingfromthesamecause.

AlarmDelays

Thereisanalarmsoundandanalarmlightilluminationdelayofnomorethan4secondsfollowing

thedisplayedalarmflag,providedthatthealarmconditionstillexistsafterthisdelay.

Alarm Safety Information

WARNINGS

• The monitor detects and responds almost immediately to most out-of-limits conditions,

except when averaging of the physiological signal is required to reduce unwanted noise

signals (for example, respiration rates and measurements derived from SpO2 signals.)

• Set the alarm volume based upon the ambient noise levels in the MR environment.

Some areas in the MR environment, such as the MR system room, may have ambient

noise levels louder than the maximum volume of the MR400. Therefore, displayed data

should be continuously monitored. Otherwise, if sound was inaudible, treatment of the

patient could be delayed. For visual alarms, adjust the position of the MR400 so that

you maintain a clear view of the display.

Visual Alarm Indications

Dependinguponthealarmcondition,visualalarmindicationscanincludeanalarmflag,a

flashingnumeric,andanilluminatedalarmlight;whenmultiplealarmsaredetected,multiple

visualindicationsmaybepresented.

Alarm Flags

Alarmflagsarevisualindicatorsthatcontainanalarmmessagedisplayedonabackgroundcolor

thatidentifiesthepriorityofthealarm(seetablebelow).Analarmflagisdisplayedforthe

durationofanalarmcondition.Multiplealarmflagsaredisplayedwhenmultiplealarm

conditionsexist.

AlarmPriority DisplayedBackgroundColor

High(patientalarm) Red

Medium(patientalarm) Yellow

INOP(statusortechnicalalarm) Blue

AlarmflagsassociatedwithavitalsignaredisplayedalongsidetheVSboxofthatparameter(see

illustrationbelow),whilealarmflagsassociatedwiththesystemaredisplayedinthesystem

messagearea(middleandtopcenterofthetouchscreen,seepage2‐21).Whenmultiplealarm

flagsarepresent,theywillbestackedinacolumn.

Flashing Numeric

Duringanpatientalarmcondition,thevitalsignnumericwillchangecolorandflashtoindicate

thesource,typeandpriorityofthealarm:

•Highprioritypatientalarm—rednumeric,flashingat1.5Hzwitha50%dutycycle.

•Mediumprioritypatientalarm—yellownumeric,flashingat0.75Hzwitha50%dutycycle.

Whiletheviolationcontinues,thenumericoftheviolatedparameterwillflashinprioritycolorof

thedetectedalarm.

Alarm Light

Duringanalarmcondition,thealarmlight(see

inset)canilluminatetoprovidea360degree,

visualindicationofthealarmpriority,asdetailed

inthetablebelow.

Multiplecolorscanbeilluminatedwhen

multiplealarmconditionsexist.Thealarmlight

isamenu‐controlledfeature;seepage4‐20for

settingdetails.

1Alarm flag (an INOP in this example)

AlarmPriority LightColor Indication

High(patientalarm) RedFlashing,1.5Hzwitha50%dutycycle

Medium(patientalarm) YellowFlashing,0.75Hzwitha50%dutycycle

INOP(statusortechnicalalarm) Blue Steady

Alarm light, red or yellow

Alarm light, blue

Speaker

Display panel

4‐4AlarmsExpressionMR400InstructionsforUse

Audible Alarm Indications

WARNING

Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of

alarm volume to a low level or off during patient monitoring may result in patient danger.

Remember that the most reliable method of patient monitoring combines close personal

surveillance with correct operation of monitoring equipment.

Dependingupontheseverityandtypeofthealarmcondition,alarmprioritytoneswithdistinct

pitchesaresoundedbythespeaker(seeillustrationonpage4‐3).Whenmultiplealarmsare

detected,thehighestpriorityalarmisannounced.

Onceactivated,anaudiblealarmindicationcontinuesaslongasthealarmconditionispresentor

untilyouacknowledgethealarmbypressingtheAudioPausekeyortheAlarmkey(orbyplacing

theMR400insuspendmode).

Alarm Sound State Indication

Dependinguponthecurrentsetting,oneofthreepossiblesymbolsareprovidedtoindicatethe

alarmsoundstate,whichisdisplayedatalltimesintheinformationbar(seepage2‐14).Symbol

definitionsforthealarmsoundstateareprovidedinthetablebelow.

Alarm priority Fixed Pitch Mnemonic Notes

High c c c – c c

Medium c c c

INOP e c

Displayed Symbol Alarm Sound State

Alarm audio armed

Alarm audio paused

Alarm audio off

Initial Audible Alarm Setting Indications

Afterpower‐upandimmediatelyfollowingtherecallofastoredsetup,theMR400providesan

indicationofthealarmvolumebysoundingthealarmtoneatitscurrentlyadjustedsettingfor5

secondsandbydisplayingCheckAlarmVolume.

Audiopausedistheinitialalarmstateandthen,followingawaitperiodof120seconds,armed

becomesthenormalalarmstate,where:

•Analarmwillsoundwhileanalarmconditionexists,providedthatanypre‐alarmsound

delayhasexpiredandthatthealarmaudioarmedsymbolisdisplayed.

•Alarmflagsrelatedtootheralarmsoundstateswillberemovedfromthedisplay.

•Analarmconditionnotpreviouslyplacedinanalarmaudiooffstatewillcausethealarmto

sound.

Controlling the Alarm Audio and Light Indications

Alarmaudioindicationsandthealarmlightcanbecontrolledtomeetthedesiredlevelof

responseusingtheAudioPausekeyortheAlarmkey.

Note

When an alarm is indicated, always confirm the alarm conditions with clinical observations of the

patient before administering interventions. Failure to do so may result in inappropriate

intervention.

1Audio Pause key

2Alarm key

4‐6AlarmsExpressionMR400InstructionsforUse

Audio Pause Mode

Audiopausemodecanisusefultotemporarilysilencealarmsandtotemporarilyextinguishthe

alarmlight(forexample,whenchangingECGleadsorduringotheruseractivitiesthatmightcause

a“false”alarm).

AudiopausemodeisindicatedwhentheAudioPausedalarmflag,theaudiopausedsymbol(see

page4‐4)andacountdowntimeraredisplayed.(The120‐secondcountdowntimerperiodisnot

useradjustable.)Duringthisperiod,theaudiblealarmwillbesuspendedforanynewalarm

conditionsthatoccur.Anymessagesrelatedtootheralarmsoundstateswillberemoved.

ToactivateAudioPause

PresstheAudioPausekey:

•Ifthealarmisnotsounding,pressthekeyonce.

•Ifthealarmissounding,pressthekeytwice.

TodeactivateAudioPause

•Waituntilthe120‐secondcountdownreacheszero(0),or

•PresstheAudioPausekey.

Audio Off Mode

Inaudiooffmode,thealarmtonewillcease,thealarmlightwillbeextinguished,andtheAudio

Offmessageandtheaudiooffsymbol(seepage4‐4)willbedisplayed.Anynewalarmcondition

willcauseaudiooffmodetobeexitedandthealarmtonetobesounded.However,acurrent

alarmconditionpreviouslysilencedwillnotsoundagainunlesstheconditionreturnswithinlimits

andthenviolatesalimitagain.

Audiooffmodeallowsyoutodisablethealarmtoneandalarmlightduringanalarmcondition,

whileallowingnewalarmconditionstoreactivateallalarmfunctions.Whiletheviolation

continues,thenumericoftheviolatedparameterwillflashinprioritycolorofthedetected

alarm.

WARNING

An active silenced alarm may not be accompanied by the Audio Off message and symbol

, if Audio Paused has been activated, or if a subsequent additional alarm has occurred

and was self-corrected.

ToactivateAudioOff

PresstheAlarmkey.

TodeactivateAudioOff

PresstheAlarmkeyagain.

Alarm Volume

Theloudnessofthealarmsoundscanbeadjusted(45–86dB,typical).

WARNING

Always ensure that the alarm sound setting is appropriate for each patient. The alarm sound

volume is adjustable for suitability to various clinical environments. When you use the

MR400, always ensure that the alarm sound can be heard above the ambient noise level.

Failure to do so may cause a lapse in patient monitoring.

Tocontrolthealarmvolume

Alarm Reset

Resettingthealarmresultsinthefollowingalarmsystembehaviors:

•Theauditoryalarmsignalsofphysiologicalalarmconditionscease,enablingthealarm

systemtorespondtoasubsequentalarmcondition.

•Alarmlightindicationscease.

•Alarmflagsforanyexistingalarmscontinueaslongasthosealarmconditionsexist.

•Thealarmsystemisenabledimmediatelysothatitcanrespondtoasubsequentalarm

condition.

•ThevisualalarmsignalsofINOPconditionsdonotceaseaslongastheINOPalarm

conditionexists.

ThealarmcanberesetbypressingtheAudioPausekeyonetime.

Step Action

1PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

2OntheMonitorSetupmenu,selectSoundAdjust.

TheSoundAdjustmenuappears.Currentsettingsaredisplayed.

3 SelectAlarmVolume.

1–10

Themenuitemappears.Thecurrentsettingishighlighted.

4 Selectthedesiredsettingfromthemenuoptions.

Thesettingisenteredandamomentarysoundatthe

correspondinglevelisproduced

4‐8AlarmsExpressionMR400InstructionsforUse

Managing Alarm Functions

WARNINGS

• Always respond promptly to any alarm condition; otherwise, treatment of the patient

could be delayed.

• You should ensure that the current alarm preset is appropriate prior to use on each

patient. Failure to do so may cause a lapse in patient monitoring.

• Setting the alarm limits to extreme values can render alarm monitoring useless. Also,

potential hazard can exist if different alarm monitoring settings are used for the same

or similar equipment in any single patient care unit. Ignoring these restrictions may

cause a lapse in patient monitoring.

TheMR400canbesettoprovidevisualalarmsignalsonly,orbothvisualandaudiblealarm

signals.Theaudiblealarmstateswillhavenoeffectonanyofthevisualalarmsdisplayedbythe

MR400(orIP5,ifequipped).

AllsettingsintheAlarmsmenu(exceptAlarmSound)canbestoredandrecalled.

Restrictionstoalarmpresetsarenotprovidedduetothefastpacedworkflow,shortaverage

durationtimeofMRIscans,differentpatienttypesscheduledforMRIprocedures,anddirect

patientsupervisionprovidedduringMRIprocedures.

Note

If the MR400 is networked to an IP5, alarm indications occur at both the MR400 and the IP5; and

control of alarms, including sound level, is localized to the device (MR400 or IP5) indicating the

alarm condition.

Showing or Hiding Current Alarm Limits

CurrenthighandlowalarmlimitsettingsaredisplayedintheVSboxofeachmonitored

parameterbydefault(exceptbellows‐derivedrespiration).

Tocontrolthedisplayfunctionforthealarmlimitsettings

Step Action

1PresstheSetupkeyandthentheAlarmskey.

TheAlarmsmenuappears.Currentsettingsaredisplayed.

Adjusting the Alarm Limits

WARNING

Alarm limits can be set to a wide range of values, including off (with the exception of O2,

N2O and FiCO2). It is the responsibility of the operator of the MR400 to ensure that alarm

limit values appropriate for each patient are established and set. Failure to do so may cause

a lapse in patient monitoring.

TheMR400providesversatilemethodstocontrolthesettingsforthepatientparameteralarms.

Eachpatientparameter(withtheexceptionofbellowsrespiration)hasalowandhighalarmlimit

setting(seethetableonpage4‐22),whichcanbechangedmanuallyorautomatically,unlessthe

parameterisoff.

Alarm Limit Controls

Individualalarmlimitsettingscanbeadjustedbytouchingtherespectiveparameterlabelinthe

AlarmsortheGasAlarmsmenu.

2 SelectLimitsDisplay.

TheLimitsDisplaymenuappears.Thecurrentsettingis

highlighted.

3 Selectthedesiredoptionfordisplayofthealarmlimitsettings:

Off

Thesettingisselected.

Step Action

4‐10AlarmsExpressionMR400InstructionsforUse

1Parameter label for alarm limit settings (active adjustment shown)

2Low button

3Lower alarm limit setting

4Upper alarm limit setting

5High button

6Off button

7Clear entry button

8Enter button

9 Decimal point button

10 Gas Alarms button

11 Alarms button

12 Plus / minus button

13 Keypad

14 Decrement button

15 Current adjustment

16 Increment button

13245

11 9

7 6

The Alarm Window

Alarmlimitshaveminimumandmaximumvaluesthatarenotadjustable(seepage4‐22).Within

theminimumandmaximumalarmlimits,adjustablelowerandupperlimitsettingsestablishan

alarmwindow.Vitalsignmeasurementsthatfallwithinthealarmwindowwillnotresultinan

physiologicalalarm.Itisonlywhenavitalsignmeasurementexceedsthealarmwindowfora

monitoredparameterthataphysiologicalalarmwillbedeclared.(Anillustrationisshownbelow.)

Advanced Alarm Functions

TheMR400featuresadvancedalarmfunctionsthatcanalertyoutospecificormoreextreme

physiologicalconditions.Whenadjustingtheseadvancedfunctionalarms,thefollowingrules

governthealarmsettings:

ExtremeBradycardiaAlarmSetting

TheExtremeBradycardiaalarmsettingisestablishedbythesettingoftheExtremeBradycardia

deltavalue.TheExtremeBradycardiadeltavaluecannotbegreaterthanthedifferencebetween

theHRlowalarmlimitsettingandthealarmlimitminimum.Themaximumallowabledeltavalue

is50.Seepage5‐24forsettingdetails.

TheExtremeBradycardiadeltavaluewillretainitsadjustedvalueastheHRlowalarmlimit

settingisadjustedupward,butwillbegintoshrinkinvalueasthelowalarmlimitsettingis

adjustedclosertothealarmlimitminimum.

ExtremeTachycardiaAlarmSetting

TheExtremeTachycardiaalarmsettingisestablishedthesettingoftheExtremeTachycardia

deltavalue.TheExtremeTachycardiadeltavaluecannotbegreaterthanthedifferencebetween

theHRalarmlimitmaximumandthehighalarmlimitsetting.Themaximumallowabledelta

valueis50.Seepage5‐24forsettingdetails.

1Parameter name (TEMP in this example)

2Alarm limit, minimum

3Lower alarm limit setting

4Alarm window

5Alarm limit, maximum

6Upper alarm limit setting

2 3 456

4‐12AlarmsExpressionMR400InstructionsforUse

TheExtremeTachycardiadeltavaluewillretainitsadjustedvalueastheHRhighalarmlimit

settingisadjusteddownward,butwillbegintoshrinkinvalueasthehighalarmlimitsettingis

adjustedclosertothealarmlimitmaximum.

DesatAlarmSetting

TheDesatalarmsettingisrestrictedtoamaximumvaluethatis2lesstheSPO2lowalarmlimit

setting,whiletheminimumsettingcanbeaslowasthealarmminimum.Seepage6‐11forsetting

details.

AslongastheSPO2parameterison,theDesatalarmvaluewillretainthissettingevenifthefunc‐

tionisturnedoffandon.

TheSPO2alarmadjustmentsaredesignedtogiveprioritytotheDesatalarmsetting.Therefore,

theSPO2lowandhighalarmlimitsmayalsobeadjustedbasedonachangemadetotheDesat

alarmsetting.WhenevertheDesatalarmsettingischanged,thefollowingrulesdeterminethe

lowerandupperSPO2alarmlimits:

•IftheDesatalarmwasturnedonafterbeingsetandturnedoff,thenifthelastsetvalueof

theSPO2lowalarmlimitislessthantheDesatalarmsettingplus2,theSPO2lowalarm

limitwillbesettotheDesatalarmsettingplus2.

•IftheDesatalarmisadjustedupwardsothatthesettingisgreaterthanorequaltothe

SPO2lowalarmlimitminus2,thentheSPO2lowalarmlimitwillbeincreasedbythe

systemsuchthattheDesatalarmsettingplus2isalwaysmaintained(i.e.,thelowalarm

limitwillalwaysmovetostaytwogreaterthanDesatalarmsetting).Iflowalarmlimitis

alteredduetothisscenario,lowalarmlimitwillretainthisalteredvalueeveniftheDesat

alarmsettingisadjusteddownward.

•TheSPO2highalarmlimitwillbeadjustedasnecessaryinrelationtothelowalarmlimitas

perthenormalbehavioroflowandhighalarmlimits.

•TheSPO2lowalarmlimitwillbeallowedtobeadjusteddownwardonlyuntilitisequalto

theDesatalarmsettingplus2.Nofurtherdownwardadjustmentoflowalarmlimitwillbe

alloweduntiltheDesatalarmsettingisadjusteddownward.

Setting Alarm Limits Globally

Globalchangestoallofthelowerandupperalarmlimitsettingscanbemadeautomaticallyby

pressingtheusingthe1‐TouchAlarmskey.Theseglobalchangesarecalculatedusing

percentagesselectedinthe1‐TouchHigh%andthe1‐TouchLow%options;seepage4‐17.

Duringcalculationsifapatient’smonitoredvalueissohighorlowthatitwouldexceedthealarm

limitrangefortheparameter,thenthealarmlimitwillbesettothehighestorlowestpossible

valuebutnotoff,asindicatedinthetableonpage4‐22.Forexample,ifafterpressingthe1‐

TouchAlarmskey,apatient’sSPO2upperalarmlimitsettingwas99(thehighestallowable

value),thenanalarmwillbegeneratedifthepatient’sreadingreaches100.(Toturnoffanalarm

limit,seeSettingAlarmLimitsIndividuallyonpage4‐13.)

AlsonotethatsettingalarmlimitsgloballymayresultinalowerSPO2alarmlimitthanthe

defaultsetting.ForapatientthathasanSpO2readingof99%,thenewupperlimitwillbe99but

thenewlowerlimitwillbe79(insteadof85)ata1‐TouchHigh%of20(factorydefault).

Toadjusttheupperandloweralarmlimitsettingsforallmonitoredparameters

Setting Alarm Limits Individually

Lowerandupperalarmlimitsettingsforeachparametercanbeindividuallyadjustedinthe

Alarmsmenu(orinthemenuoftheparameterthatyouwanttochange,bytouchingthealarm

limitsettingsinparameter’sVSbox).

IntheAlarmsmenu,lowerandupperalarmlimitsettingsforparametersareprovided,asshown

below.(Forinformationaboutgasalarms,seechapter9.)Anindividualalarmlimitsettingcanbe

adjustedbytouchingthelowerorupperalarmlimitoftherespectiveparameterintheAlarms

menu.

Step Action

1PresstheSetupkeyandthentheAlarmskey.

TheAlarmsmenuappears.Currentsettingsaredisplayed.

2 Select1‐TouchHigh%.

The1‐TouchHigh%menuappears.Thecurrentsettingis

highlighted.

3 Selectthedesiredpercentage:

10%

15%

20%

30%

Thesettingisselected.

4 SelectLowerWindow.

TheLowerWindowmenuappears.Thecurrentsettingis

highlighted.

5 Selectthedesiredpercentage:

10%

15%

20%

30%

Thesettingisselected.

6Pressthe1‐TouchAlarmskey.

Allactivealarmlimitsettingsarechanged.

4‐14AlarmsExpressionMR400InstructionsforUse

ToadjustthealarmlimitsettingsforasingleparameterintheAlarmsmenu

1TEMP – (Temperature)

2P1 (Sys) – (P1 [Systolic])

3P1 (Dia) – (P1 [Diastolic])

4P1 (Mean)

5P2 (Sys) – (P2 [Systolic])

6P2 (Dia) – (P2 [Diastolic])

7P2 (Mean)

8CO2 (RESP) – (CO2 [Respiration])

9CO2 (Fi) – (CO2 [Fractional inspired])

10 CO2 (Et) – (CO2 [End-tidal])

11 NIBP (Mean)

12 NIBP (Dia) – (NIBP [Diastolic])

13 NIBP (Sys) – (NIBP [Systolic])

14 SPO2

15 HR – (Heart rate)

Step Action

1PresstheSetupkeyandthentheAlarmskey.

TheAlarmsmenuappears.Currentsettingsaredisplayed.

2PressthedesiredparameterlabelontheAlarmsmenu:

SPO2

NIBP(Sys)

NIBP(Dia)

NIBP(Mean)

CO2(Et)

CO2(Fi)

CO2(RESP)

TEMP

P1(Sys)

P1(Dia)

P1(Mean)

P2(Sys)

P2(Dia)

P2(Mean)

Thebackgroundoftheselectedparameterbecomeshighlighted

(TEMPinthisexample).

3 Dependinguponthealarmlimittobemodified,presstheLow

buttonortheHighbutton.

Inthisexample,theLowbuttonwasselectedtoadjustthelower

alarmlimitsetting.

Step Action

Parameter

label

Low

button

High

button

4‐16AlarmsExpressionMR400InstructionsforUse

Restoring Alarm Limit Defaults

WheneverthePatientTypesettingischanged(seepage3‐11),theMR400automaticallyrestores

thedefaultvaluestoallthealarmlimitsettings;seepage4‐24foralistingofthedefaultvalues.

Toimmediatelyrestorethealarmlimitstothedefaultsettings

4Usetheincrementorthedecrementbuttontoadjustthesetting.

Or,directlyinputthevalueusingthekeypad,theplus/minus

buttonand/orthedecimalpointbuttonthenpresstheEnter

button.(Foritemlocations,seeAlarmLimitControlsonpage4‐9.)

Thecurrentadjustmentwillreflectthesetting.(Inthisexample,the

lowerlimitsettingwasadjustedfrom36to33.)

5Tochangetheremainingsetting,repeatsteps3and4.

6Tochangeanyremainingparameters,repeatsteps2,3,and4.

7PresstheMainScreenkeytoclosethemenu.

Newlimitsettingswillbeindicatedintheparameter’sVSbox.

Step Action

Adjusted lower limit

Lower alarm limit setting

Step Action

1PresstheSetupkeyandthentheAlarmskey.

TheAlarmsmenuappears.Currentsettingsaredisplayed.

2 SelectDefaultLimits.

Thealarmlimitsettingsarereturnedtothedefaultvalues.

Enabling Print on Alarm

IftheMR400isconnectedtoanIP5thatisequippedwithaprinter,aprintoutcanbe

automaticallygeneratedwhenaphysiologicalalarmoccurs.SeetheIP5IFUfordetails.

Alarms Menu

TheAlarmsmenuallowsyoutoconfiguretheMR400forsetupandcontrolofthevitalsign

alarms.

ToopentheAlarmsmenu

PresstheSetupkeyandthentheAlarmskey.

Notes

• Select the Alarms button to access the alarm limits settings for parameters.

• Select the Gas Alarms button to access the alarm limits settings for AGENT and GAS.

Alarms menu Setup key

Alarms key

Alarms button

Gas Alarms button

4‐18AlarmsExpressionMR400InstructionsforUse

ThefollowingAlarmsmenuitemsareavailable:

TochangesettingsintheAlarmsmenu

1-Touch High %

Setsapercentvalueusedtocalculatethehighalarmlimitswhenthe1‐TouchAlarmskeyis

pressed.Thecurrentparametervalueisbracketedwiththepercentagessetinthismenuandin

the1‐TouchLow%menu.

Thefollowingoptionsareavailable:

•5%

• 1-Touch High %

• 1-Touch Low %

•Alarm Sound

•Alarm Light

•Default Limits

• Limits Display

Step Action

1PresstheSetupkeyandthentheAlarmskey.

TheAlarmsmenuappears.Currentsettingsaredisplayed.

2 Selectanyofthefollowingmenuitems:

1‐TouchHigh%

1‐TouchLow%

AlarmSound

AlarmLight

DefaultLimits

LimitsDisplay

Forinformationabouttheseoptions,seetheappropriatesections

below.

3 Selectthedesiredmenuitem.

Thecurrentsettingishighlighted.

4 Selectthedesiredsettingfromthemenuoptions.

Thesettingisentered.

5Tochangeothersettings,repeatsteps2,3and4.

•10%

•15%

•20%(Default)

•30%

Tosettheupperwindow

SeeSettingAlarmLimitsGloballyonpage4‐12.

Note

If, during calculation, a patient’s monitored value is so high that it exceeds the alarm limit range

for the parameter, then the respective alarm limit will be set to the highest value but not off, as

indicated in the table on page 4-22.

1-Touch Low %

Setsapercentvalueusedtocalculatethelowalarmlimitswhenthe1‐TouchAlarmskeyis

pressed.Thecurrentparametervalueisbracketedwiththepercentagessetinthismenuandin

the1‐TouchHigh%menu.

Thefollowingoptionsareavailable:

•5%

•10%

•15%

•20%(Default)

•30%

Tosetthelowercalculationvalue

SeeSettingAlarmLimitsGloballyonpage4‐12.

Note

If, during calculation, a patient’s monitored value is so low that it exceeds the alarm limit range

for the parameter, then the respective alarm limit will be set to lowest possible value but not off, as

indicated in the table on page 4-22.

4‐20AlarmsExpressionMR400InstructionsforUse

Alarm Sound

WARNING

The alarm sound can be turned off, as indicated by the symbol. Always ensure that the

alarm sound setting is appropriate for the monitoring environment and for each patient. The

alarm sound volume is adjustable for suitability to various clinical environments. When you

use the MR400, always ensure that the alarm sound can be heard above the ambient noise

level; otherwise, treatment of the patient could be delayed.

Controlsthealarmsound(identicaltoandinteractivewithAlarmsintheMonitorSetup>Sound

Adjustmenu).

Thefollowingoptionsareavailable:

•Offturnsoffthealarmsound,asindicatedbythealarmaudiooffsymbol(seepage4‐4).

(Onlythealarmsoundwillbedisabled;visualalarmindicationswillcontinue.)

•Onturnsonthealarmsound,asindicatedbythealarmaudioarmedsymbol(seepage4‐

4).(Default)

Tocontrolthealarmsound

Alarm Light

Setsthebehaviorofthealarmlightfollowingthedetectionofanalarm.

Thefollowingoptionsareavailable:

•Continuousilluminatesthealarmlightforthedurationofanalarmcondition.(Default)

• Temporaryilluminatesthealarmlightfor25secondsduringanalarmcondition.(Ifthe

MR400isplacedinsuspendmodeorifthealarmissilencedorpausedduringthisperiod,

thenuponexitingthealarmlightwillrestartfor25seconds.)

•Offdoesnotilluminatethealarmlightduringanalarmcondition.

Step Action

1PresstheSetupkeyandthentheAlarmskey.

TheAlarmsmenuappears.Currentsettingsaredisplayed.

2LocateAlarmSoundandselectthedesiredsetting:

Off

Thesettingisentered.

Note

As defined in the table below, the current Alarm Light setting is indicated by the displayed symbol

on the information bar (see page 2-14).

Toadjustthealarmlightsetting

Default Limits

Automaticallysetsthelowalarmlimitsandhighalarmlimitsforallparameterstothedefault

values(seethetableonpage4‐24).

Tosetthealarmlimitsettingstothedefaultlimits

SeeRestoringAlarmLimitDefaultsonpage4‐16.

Limits Display

ControlsthevisibilityofthealarmlimitsettingsintheVSboxes.

Thefollowingoptionsareavailable:

Alarm Light Setting Displayed Symbol

Continuous

Temporary

Off

Step Action

1PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

2OntheMonitorSetupmenu,selectAlarmLight.

TheAlarmLightmenuappears.Thecurrentsettingishighlighted.

3 Selectthedesiredsettingfromthemenuoptions:

Continuous

Temporary

Off

Thesettingisentered.

4‐22AlarmsExpressionMR400InstructionsforUse

•Offdoesnotdisplaythealarmlimitsettings.

•Ondisplaysthealarmlimitsettings.(Default)

Tocontrolthedisplayfunctionforthealarmlimitsettings

Adjustable Alarm Limit Ranges

Withtheexceptionofbellowsrespiration,eachparameteralarmhasadjustablelimitsasindicatedin

thetablesbelow



Notethatthealarmlimitnumericvaluescanbesettooff,withtheexceptionof

O2,N2O,FiCO2.

TheMR400alsopreventscrossoveroflowandhighalarmlimitsettings,anda

minimumnumberofunitsseparatestheselowandhighsettings.Whenaparameterhasbeen

turnedoff,itsalarmlimitswillbeoff.Alarmlimitsareadjustablebythesameresolutionspecifiedin

eachparameter'smeasurementresolutionsetforthinAppendixA.

Note

The minimum and maximum values for the low and high limits represent the most extreme settings

possible. For some vital signs, these values can be obtained for a low or high alarm limit only if

the other limit is off.

ThetablebelowprovidesthealarmlimitrangesfortheMR400.

Step Action

1PresstheSetupkeyandthentheAlarmskey.

TheAlarmsmenuappears.Currentsettingsaredisplayed.

2 SelectLimitsDisplay.

TheLimitsDisplaymenuappears.Thecurrentsettingis

highlighted.

3 Selectthedesiredoptionfordisplayofthealarmlimitsettings:

Off

Thesettingisselected.

Vital Sign or

Parameter Unit Patient Type

Low Alarm Limit*High Alarm Limit*Low and

High Limit

Separation

Minimum Maximum Minimum Maximum

HR BPM All Off, 30 250 60 250, Off 2

SPO2 Percent All Off, 50 100 70 100, Off 2

CO2 (Et) mmHg

kPa

All Off, 5

Off, 0.7

8.0

0.7

90, Off

12.0, Off

*ForallalarmlimitvaluesthatmaybedisplayedinunitsofkPa,allow+/‐0.1kPaofvariancetoaccountforroundingerrorthatmay

occurwhenconvertingfrommmHgtokPa.

Thefollowingtableprovidesthealarmlimitrangesfortheanestheticagentgasesandoxygenfor

allpatienttypes.

CO2 (Fi) mmHg

kPa

All No low alarm 0 20, Off

2.7, Off

CO2 (Resp) RPM All Off, 4 40 20 100, Off 2

P1 and P2 mmHg

kPa

All Off, -30

Off, -4.0

250

33.3

-30

-4.0

250, Off

33.3, Off

Temperature °C

°F

All Off, 20.0

Off, 68.0

44.0

111.2

20.0

68.0

44.0, Off

111.2, Off

NIBP — Systolic mmHg

kPa

Adult Off, 30

Off, 4.0

270

36.0

4.0

270, Off

36.0, Off

— Mean mmHg

kPa

Adult Off, 20

Off, 2.7

255

34.0

2.7

255, Off

34.0, Off

— Diastolic mmHg

kPa

Adult Off, 10

Off, 1.3

245

32.7

1.3

245, Off

32.7, Off

NIBP — Systolic mmHg

kPa

Pediatric Off, 30

Off, 4.0

180

24.0

4.0

180, Off

24.0, Off

— Mean mmHg

kPa

Pediatric Off, 20

Off, 2.7

160

21.3

2.7

160, Off

21.3, Off

— Diastolic mmHg

kPa

Pediatric Off, 10

Off, 1.3

150

20.0

1.3

150, Off

20.0, Off

NIBP — Systolic mmHg

kPa

Neo Off, 30

Off, 4.0

130

17.3

4.0

130, Off

17.3, Off 2

— Mean mmHg

kPa

Neo Off, 20

Off, 2.7

120

16.0

2.7

120, Off

16.0, Off 2

— Diastolic mmHg

kPa

Neo Off, 10

Off, 1.3

100

13.3

1.3

100, Off

13.3, Off 2

Vital Sign or

Parameter Unit Patient Type

Low Alarm Limit*High Alarm Limit*Low and

High Limit

Separation

Minimum Maximum Minimum Maximum

Breath Phase and Gas Unit

Low Alarm Limit High Alarm Limit Low and

High Limit

Separation

Minimum Maximum Minimum Maximum

DES (Et), Expired Desflurane Vol. % Off, 0.1 18.0 0.1 18.0, Off 1

DES (Fi), Inspired Desflurane Vol. % Off, 0.1 18.0 0.1 18.0, Off 1

ENF (Et) Expired Enflurane Vol. % Off, 0.1 5.0 0.1 5.0, Off 1

ENF (Fi) Inspired Enflurane Vol. % Off, 0.1 5.0 0.1 5.0, Off 1

HAL (Et) Expired Halothane Vol. % Off, 0.1 5.0 0.1 5.0, Off 1

HAL (Fi) Inspired Halothane Vol. % Off, 0.1 5.0 0.1 5.0, Off 1

ISO (Et) Expired Isoflurane Vol. % Off, 0.1 5.0 0.1 5.0, Off 1

ISO (Fi) Inspired Isoflurane Vol. % Off, 0.1 5.0 0.1 5.0, Off 1

4‐24AlarmsExpressionMR400InstructionsforUse

Alarm Limit Factory Defaults

Intheeventofpowerloss,anyalarmlimitsettingsthatwerechangedwillbelost.Allsettingsthat

mayhavebeenmodifiedtosuitaparticularpatientshouldbeconfirmedbeforemonitoring.

Atpowerup,theMR400willautomaticallysetallalarmlimitsasdeterminedbythedefault

selectedintheEditUserSettingsmenu;seepage3‐15.Thefactorydefaultalarmlimitsarelisted

inthetablebelow.

Note

You are restricted from making changes to the factory default settings.

SEV (Et) Expired Sevoflurane Vol. % Off, 0.1 8.0 0.1 8.0, Off 1

SEV (Fi) Inspired Sevoflurane Vol. % Off, 0.1 8.0 0.1 8.0, Off 1

N2O (Fi) Inspired Nitrous

Oxide Percent No low alarm 0 80 1

O2 (Fi) Inspired Oxygen Percent 18 100 18 100 1

Breath Phase and Gas Unit

Low Alarm Limit High Alarm Limit Low and

High Limit

Separation

Minimum Maximum Minimum Maximum

Vital Sign or Parameter Unit

Adult Pediatric Neo

Low

Limit

High

Limit

Low

Limit

High

Limit

Low

Limit

High

Limit

Heart Rate BPM 45 160 75 160 90 210

Heart Rate - Extreme

Bradycardia

BPM202020202020

Heart Rate - Extreme

Tachycardia

BPM202020202020

SPO2 Percent 85 Off 90 Off 90 Off

SPO2 - Desat Percent 80 80 80 80 80 80

CO2 (Et) mmHg

kPa

2.0

8.0

2.0

8.0

4.0

6.0

CO2 (Fi) mmHg

kPa

No low

alarm

0.5

No low

alarm

0.5

No low

alarm

0.5

CO2 (Resp) RPM 4 40 4 40 30 70

P1 / P2 Systolic mmHg

kPa

8.7

190

25.3

9.3

120

16.0

9.3

100

13.3

P1 / P2 Mean mmHg

kPa

7.3

135

18.0

6.7

12.0

5.3

12.0

P1 / P2 Diastolic mmHg

kPa

5.3

125

16.7

5.3

9.3

4.7

6.7

*ForallalarmlimitvaluesthatmaybedisplayedinunitsofkPa,allow+/‐0.1kPaofvariancetoaccountforroundingerrorthatmay

occurwhenconvertingfrommmHgtokPa.

Measurement Limits and Over / Under Values

Inthetablebelow,therangeofvaluesthatcanbemeasuredforavitalsignitemareprovided

alongwiththehighandlowvaluesthat,beyondwhich,anoverorunderindicationwillbegiven.

Specifically,avaluewillbemarkedasOver(OVR)iftheVSvalueisgreaterthanthegivenover

value,andmarkedasUnder(UND)iftheVSvalueislessthanthegivenundervalue.

NIBP Systolic mmHg

kPa

8.7

190

25.3

9.3

120

16.0

9.3

100

13.3

NIBP Mean mmHg

kPa

7.3

135

18.0

6.7

12.0

5.3

12.0

NIBP Diastolic mmHg

kPa

5.3

125

16.7

5.3

9.3

4.7

6.7

Temperature °C

°F

36.0

96.8

39.0

102.2

36.0

96.8

39.0

102.2

36.0

96.8

39.0

102.2

DES (Et), Expired Desflurane Vol. % Off 12.0 Off 12.0 Off 12.0

DES (Fi), Inspired Desflurane Vol. % Off 18.0 Off 18.0 Off 18.0

ENF (Et) Expired Enflurane Vol. % Off 3.4 Off 3.4 Off 3.4

ENF (Fi) Inspired Enflurane Vol. % Off 5.0 Off 5.0 Off 5.0

HAL (Et) Expired Halothane Vol. % Off 1.5 Off 1.5 Off 1.5

HAL (Fi) Inspired Halothane Vol. % Off 2.2 Off 2.2 Off 2.2

ISO (Et) Expired Isoflurane Vol. % Off 2.3 Off 2.3 Off 2.3

ISO (Fi) Inspired Isoflurane Vol. % Off 3.4 Off 3.4 Off 3.4

SEV (Et) Expired Sevoflurane Vol. % Off 4.1 Off 4.1 Off 4.1

SEV (Fi) Inspired Sevoflurane Vol. % Off 6.1 Off 6.1 Off 6.1

N2O (Fi) Inspired Nitrous

Oxide

Percent No low

alarm 80 No low

alarm 80

O2 (Fi) Inspired OxygenPercent189918991899

Vital Sign or Parameter Unit

Adult Pediatric Neo

Low

Limit

High

Limit

Low

Limit

High

Limit

Low

Limit

High

Limit

Vital Sign or

Parameter

Numeric

Item Units Patient

Type

Measurement

Range

Over / Under

Values

Low High Under Over

ECG Heart Rate BPM Adult 30 250 30 250

ECG Heart Rate BPM Ped 30 300 30 300

ECG Heart Rate BPM Neo 30 300 30 300

SPO2 Heart Rate BPM All 30 250 30 250

4‐26AlarmsExpressionMR400InstructionsforUse

Listing of Alarms

Thissectionlistspatientalarmsalphabetically,andtechnicalalarms(INOPs)arrangedbythe

sourceoftheINOPandthenalphabetically,irrespectiveofpriority.AllalarmsandINOPsare

listedhere;thosewhichcanappearonyourMR400willdependontheinstalledoptions.

SPO2 Saturation % All 1 100 none none

P1 and P2 Systolic mmHg Adult -30 250 -30 250

P1 and P2 Mean mmHg Ped -30 250 -30 250

P1 and P2 Diastolic mmHg Neo -30 250 -30 250

P1 and P2 Pulse Rate BPM All 30 250 30 250

NIBP Systolic mmHg Adult 30 270 30 270

NIBP Systolic mmHg Ped 30 180 30 180

NIBP Systolic mmHg Neo 30 130 30 130

NIBP Mean mmHg Adult 20 255 20 255

NIBP Mean mmHg Ped 20 160 20 160

NIBP Mean mmHg Neo 20 120 20 120

NIBP Diastolic mmHg Adult 10 245 10 245

NIBP Diastolic mmHg Ped 10 150 10 150

NIBP Diastolic mmHg Neo 10 100 10 100

Temperature Temperature °C All 20.0 44.0 20.0 44.0

CO2 (LoFlo option) CO2 (Et) mmHg All 0 90 none 90

CO2 (LoFlo option) CO2 (Fi) mmHg All 0 90 none 90

CO2 (LoFlo option) Resp. Rate RPM All 4 100 none 100

CO2 (AGENT option) CO2 (Et) mmHg All 0 90 none 90

CO2 (AGENT option) CO2 (Fi) mmHg All 0 90 none 90

CO2 (AGENT option) Resp. Rate RPM All 4 100 4 100

AGENT Desflurane (Et & Fi) % All 0 18.0 none 18.0

AGENT Enflurane (Et & Fi) % All 0 5.0 none 5.0

AGENT Halothane (Et & Fi) % All 0 5.0 none 5.0

AGENT Isoflurane (Et & Fi) % All 0 5.0 none 5.0

AGENT Sevoflurane (Et & Fi) % All 0 8.0 none 8.0

AGENT N2O (Et) % All 0 100 none none

AGENT N2O (Fi) % All 0 100 none none

AGENT O2 (Fi) % All 0 100 none none

Bellows Respiration Resp. Rate RPM All 4 150 4 150

Vital Sign or

Parameter

Numeric

Item Units Patient

Type

Measurement

Range

Over / Under

Values

Low High Under Over

VitalSignValueState

Avitalsignvalueisconsideredmissing(asindicatedbythreedashes,‐‐‐)whenthevitalsignhas

producedavaluesincethemonitorwasturnedon,butcannolongerproduceavalue.Examples

ofthevaluesthatcouldbecomemissingduringnormaluse,include:

•ECGheartratevalueiftheleadsareremoved.

•SPO2valueduringNoProbe,ProbeOff,etcetera.

• Temperaturevalueiftheprobewasremoved.

•Invasivepressurevaluesifthetransducerisremoved.

WhenavaluebecomesmissingduetoanINOP,anINOPalarmwillbepresent.And,apatient

alarm—duetothemissingvalue—willbepresentaswell.Therefore,thesystemcanhavean

INOPalarm,andapatientalarm,activeatthesametimeandfromthesamecause.

WARNING

If, during use, an alarm condition listed below results in a loss of patient monitoring

capability, employ an alternate means as needed to prevent a lapse in patient monitoring;

otherwise, treatment of the patient could be delayed.

Patient and INOP Alarms

Themeasurementlabelsandabbreviationsforpressure,temperature,SpO2,CO2andanesthetic

agentalarmsareexplainedintheindividualchapters.Thefollowingtablecontainsalistingof

patientalarmsarrangedbyvitalsignorparameter.Theparametermustbeonfortherespective

alarmdetectionstobeenabled;seepage3‐18.

Note

In the case of missing data (- - -), an alarm will occur only if a valid numeric was previously displayed but can

no longer be produced; see page 2-20 for details.

Patient Alarm From Condition Indication

Extreme Brady ECG, SPO2, P1

(or P2)

The heart rate measurement has

violated the Extreme Bradycardia

alarm setting.

Red flag in ECG alarm flag area, flashing red

heart rate numeric in the ECG VS box and in

the SPO2 VS box, red alarm light, high priority

alarm tone

Extreme Tachy ECG, SPO2, P1

(or P2)

The heart rate measurement has

violated the Extreme Tachycardia

alarm setting.

Red flag in ECG alarm flag area, flashing red

heart rate numeric in the ECG VS box and in

the SPO2 VS box, red alarm light, high priority

alarm tone

Violated heart rate

value

ECG, SPO2, P1

(or P2)

The heart rate measurement has

violated an alarm limit setting.

Flashing yellow heart rate numeric in the ECG

VS box and in the SPO2 VS box, yellow alarm

light, medium priority alarm tone

4‐28AlarmsExpressionMR400InstructionsforUse

Missing heart rate data ECG, SPO2, P1

(or P2)

The heart rate data, once present,

can no longer be produced.

Flashing yellow dashes (- - -) in the heart rate

numeric in the ECG VS box and in the SPO2

VS box, yellow alarm light, medium priority

alarm tone

Over maximum heart

rate value

ECG, SPO2, P1

(or P2)

The heart rate measurement has

violated the upper parameter

range.

Flashing red heart rate numeric alternating

between OVR and the heart rate value in the

ECG VS box and in the SPO2 VS box, red alarm

light, high priority alarm tone

Under minimum heart

rate value

ECG, SPO2, P1

(or P2)

The heart rate measurement has

violated the lower parameter

range.

Flashing red heart rate numeric alternating

between UND and the heart rate value in the

ECG VS box and in the SPO2 VS box, red alarm

light, high priority alarm tone

Desat SPO2 SPO2 has detected a desaturation

event.

Red flag in ECG alarm flag area, flashing red

SpO2 numeric, red alarm light, high priority

alarm tone

Violated arterial oxygen

saturation value

SPO2 The arterial oxygen saturation

measurement has violated an

alarm limit setting.

Flashing yellow SpO2 numeric in the SPO2 VS

box, yellow alarm light, medium priority alarm

tone

Missing arterial oxygen

saturation data

SPO2 The arterial oxygen saturation

data, once present, can no longer

be produced.

Flashing yellow dashes (- - -) in the SpO2

numeric in the SPO2 VS box, yellow alarm

light, medium priority alarm tone

Apnea CO2, AGENT The apnea time delay setting has

been exceeded.

Red flag in the CO2 or RESP alarm flag area,

Flashing red respiration rate numeric, red

alarm light, high priority alarm tone

Note

Apnea alarm flag appears in either the CO2 or

the RESP alarm flag area, based on the RESP

source.

Violated EtCO2 value CO2, AGENT The end-tidal CO2 measurement

has violated an alarm limit setting.

Flashing yellow EtCO2 numeric in the CO2 VS

box, yellow alarm light, medium priority alarm

tone, where OVR displayed if the value is

greater than the highest specified

Missing EtCO2 data CO2, AGENT The end-tidal CO2 data, once

present, can no longer be

produced.

Flashing yellow dashes (- - -) in the EtCO2

numeric in the CO2 VS box, yellow alarm light,

medium priority alarm tone

Violated FiCO2 value CO2, AGENT The fractional inspired CO2

measurement has violated an

alarm limit setting.

Flashing yellow FiCO2 numeric in the CO2 VS

box, yellow alarm light, medium priority alarm

tone, where OVR displayed if the value is

greater than the highest specified

Missing FiCO2 data CO2, AGENT The fractional inspired CO2 data,

once present, can no longer be

produced.

Flashing yellow dashes (- - -) in the FiCO2

numeric in the CO2 VS box, yellow alarm light,

medium priority alarm tone

Patient Alarm From Condition Indication

Violated CO2

respiration rate value

CO2, AGENT The CO2 respiration rate

measurement has violated an

alarm limit setting.

Depending upon RESP VS box configuration:

• Flashing yellow respiration rate numeric

in the CO2 VS box, yellow alarm light,

medium priority alarm tone, or

• Flashing yellow respiration rate numeric

in the RESP VS box, yellow alarm light,

medium priority alarm tone

• And where OVR displayed if the value is

greater than the highest specified

• And where UND if the value is less than

the lowest specified (AGENT option

only)

Missing CO2 respiration

rate data

CO2, AGENT The CO2 respiration rate data,

once present, can no longer be

produced.

Depending upon RESP VS box configuration:

• Flashing yellow dashes (- - -) in the

respiration rate numeric in the CO2 VS

box, yellow alarm light, medium priority

alarm tone, or

• Flashing yellow dashes (- - -) in the

respiration rate numeric in the RESP VS

box, yellow alarm light, medium priority

alarm tone

Violated invasive blood

pressure systolic value

P1 (and P2) The P1 (or P2) invasive blood

pressure systolic measurement has

violated an alarm limit setting.

Flashing yellow systolic numeric in the P1 VS

box, yellow alarm light, medium priority alarm

tone, where OVR displayed if the value is

greater than the highest specified or UND if

the value is less than the lowest specified

Violated invasive blood

pressure mean value

P1 (and P2) The P1 (or P2) invasive blood

pressure mean measurement has

violated an alarm limit setting.

Flashing yellow mean numeric in the P1 VS

box, yellow alarm light, medium priority alarm

tone, where OVR displayed if the value is

greater than the highest specified or UND if

the value is less than the lowest specified

Violated invasive blood

pressure diastolic value

P1 (and P2) The P1 (or P2) invasive blood

pressure diastolic measurement

has violated an alarm limit setting.

Flashing yellow diastolic numeric in the P1 VS

box, yellow alarm light, medium priority alarm

tone, where OVR displayed if the value is

greater than the highest specified or UND if

the value is less than the lowest specified

Missing invasive blood

pressure data

P1 (and P2) The P1 (or P2) invasive blood

pressure data, once present, can

no longer be produced.

Flashing yellow dashes (- - -) in the systolic,

diastolic and mean numerics in the P1 VS box,

yellow alarm light, medium priority alarm tone

Violated primary agent

Et value

AGENT The end-tidal measurement for the

primary agent gas has violated an

alarm limit setting.

Flashing yellow primary agent Et numeric in the

AGENT VS box, yellow alarm light, medium

priority alarm tone, where OVR displayed if

the value is greater than the highest specified

Violated primary agent

Fi value

AGENT The fractional inspired

measurement for the primary

agent gas has violated an alarm

limit setting.

Flashing yellow primary agent Fi numeric in the

AGENT VS box, yellow alarm light, medium

priority alarm tone, where OVR displayed if

the value is greater than the highest specified

Patient Alarm From Condition Indication

4‐30AlarmsExpressionMR400InstructionsforUse

Violated secondary

agent Et value

AGENT The end-tidal measurement for the

secondary agent gas has violated

an alarm limit setting.

Flashing yellow secondary agent Et numeric in

the AGENT VS box, yellow alarm light,

medium priority alarm tone, where OVR

displayed if the value is greater than the highest

specified

Violated secondary

agent Fi value

AGENT The fractional inspired

measurement for the secondary

agent gas has violated an alarm

limit setting.

Flashing yellow secondary agent Fi numeric in

the AGENT VS box, yellow alarm light,

medium priority alarm tone, where OVR

displayed if the value is greater than the highest

specified

Missing primary and

secondary agent data

AGENT The primary and secondary agent

data, once present, can no longer

be produced.

Flashing yellow dashes (- - -) in the primary and

secondary numerics in the AGENT VS box,

yellow alarm light, medium priority alarm tone

Violated N2O value AGENT The N2O measurement has

violated an alarm limit setting.

Flashing yellow N2O numeric in the GAS VS

box, yellow alarm light, medium priority alarm

tone

Missing N2O data AGENT The N2O data, once present, can

no longer be produced.

Flashing yellow dashes (- - -) in the N2O

numeric in the GAS VS box, yellow alarm light,

medium priority alarm tone

Violated O2 value AGENT The O2 measurement has violated

an alarm limit setting.

Flashing yellow O2 numeric in the GAS VS

box, yellow alarm light, medium priority alarm

tone

Violated O2 value AGENT The O2 measurement is less than

18 percent.

Flashing red O2 numeric in the GAS VS box,

red alarm light, high priority alarm tone

Missing O2 data AGENT The O2 data, once present, can no

longer be produced.

Flashing yellow dashes (- - -) in the O2 numeric

in the GAS VS box, yellow alarm light, medium

priority alarm tone

Missing bellows

respiration rate data

RESP The bellows respiration data, once

present, can no longer be

produced.

Flashing yellow dashes (- - -) in the respiration

rate numeric in the RESP VS box, yellow alarm

light, medium priority alarm tone

Violated temperature

value

TEMP The temperature measurement

has violated an alarm limit setting.

Flashing yellow temperature numeric in the

TEMP VS box, yellow alarm light, medium

priority alarm tone, where OVR displayed if

the value is greater than the highest specified

or UND if the value is less than the lowest

specified

Missing temperature

data

TEMP The temperature data, once

present, can no longer be

produced.

Flashing yellow dashes (- - -) in the

temperature numeric in the TEMP VS box,

yellow alarm light, medium priority alarm tone,

where OVR displayed if the value is greater

than the highest specified or UND if the value

is less than the lowest specified

Violated non-invasive

blood pressure systolic

value

NIBP The non-invasive blood pressure

systolic measurement has violated

an alarm limit setting.

Flashing yellow systolic numeric in the NIBP VS

box, yellow alarm light, medium priority alarm

tone, where OVR displayed if the value is

greater than the highest specified or UND if

the value is less than the lowest specified

Patient Alarm From Condition Indication

Technical (INOP) Alarms and Other Status Flags

ThefollowingtablecontainsalistingoftheINOPandotherstatusalarmflagmessages,locations,

toneindications,andwhereapplicablepossiblesolutions.

ECG

Violated non-invasive

blood pressure mean

value

NIBP The non-invasive blood pressure

mean measurement has violated an

alarm limit setting.

Flashing yellow mean numeric in the NIBP VS

box, yellow alarm light, medium priority alarm

tone, where OVR displayed if the value is

greater than the highest specified or UND if

the value is less than the lowest specified

Violated non-invasive

blood pressure diastolic

value

NIBP The non-invasive blood pressure

diastolic measurement has violated

an alarm limit setting.

Flashing yellow diastolic numeric in the NIBP

VS box, yellow alarm light, medium priority

alarm tone, where OVR displayed if the value

is greater than the highest specified or UND if

the value is less than the lowest specified

Missing non-invasive

blood pressure data

NIBP The non-invasive blood pressure

data, once present, can no longer

be produced.

Flashing yellow dashes (- - -) in the systolic,

diastolic and mean numerics in the NIBP VS

box, yellow alarm light, medium priority alarm

tone

Patient Alarm From Condition Indication

Message, Location,

Indication

What to Do

Lead Fail

ECG alarm flag area, blue

alarm light, INOP alarm

tone

An ECG lead (or electrode) required to measure the lead view is faulty or disconnected:

• Ensure that the ECG lead cable is connected to the wECG module, and that the wECG module

has sufficient battery power.

• Ensure that each ECG lead cable clip is connected to the Quadtrode electrode contact.

(Examine the ECG VS box for indications of a contact problem, where LL = left leg, LA = left

arm, and RA = right arm, and LL, LA, RA, = RL [right leg] or all leads.)

• Replace the ECG lead cable.

• Replace the Quadtrode electrode.

Notes

• The error message can be displayed for trace A and/or for trace B.

• May also be displayed when high DC offsets are present on an input lead.

4‐32AlarmsExpressionMR400InstructionsforUse

SPO2

Lead Saturation

ECG alarm flag area, blue

alarm light, INOP alarm

tone

Baseline offset of the ECG input signal is too large for process and display of the waveform. Replace

the Quadtrode electrode.

Note

The error message can be displayed for trace A and/or for trace B.

Message, Location,

Indication

What to Do

Bad Probe

SPO2 alarm flag area, blue

alarm light, INOP alarm

tone

The SpO2 probe is defective. Replace the SpO2 probe.

Erratic

SPO2 alarm flag area, blue

alarm light, INOP alarm

tone

The SpO2 attachment may be improperly applied or positioned on the patient; or, the probe is

faulty.

• Check the alignment of the clip (or grip) on the patient.

• Replace the SpO2 probe.

If the message persists, contact technical support or authorized service personnel.

HW Fail

SPO2 alarm flag area, blue

alarm light, INOP alarm

tone

A hardware or other failure has occurred in the wSpO2 module. Replace the wSpO2 module.

If the failure persists, immediately remove the MR400 and the wSpO2 module from service then

contact technical support or authorized service personnel, as the system must not be used on any

patient requiring SpO2 measurement.

Intrfernce

SPO2 alarm flag area, blue

alarm light, INOP alarm

tone

Interference due to attachment misalignment or incorrect attachment positioning:

• Check the alignment of the clip (or grip) on the patient site.

• Try a different limb or site.

• Ensure that the module is placed outside of the MR bore.

• Reposition the wSpO2 module (see page 6-6.

• Replace the clip (or grip).

Low Perf

SPO2 alarm flag area, blue

alarm light, INOP alarm

tone

Accuracy may be compromised due to low perfusion. The tissue at the SpO2 attachment site may

be too opaque, thick or cold.

• If the clip (or grip) is positioned on a finger, check for long, artificial or polished nails. Remove

any nail polish or relocate the attachment if needed.

• Try another attachment site, like a toe.

• Try rubbing or warming the limb to stimulate circulation.

No Probe

SPO2 alarm flag area, blue

alarm light, INOP alarm

tone

The SpO2 probe is not attached or is improperly attached to the wSpO2 module. Check the

connection of the probe to the module. Reconnect the probe or, if the connection was good,

replace the probe.

Message, Location,

Indication

What to Do

CO2 / CO (RESP) / AGENT

Noise

SPO2 alarm flag area, blue

alarm light, INOP alarm

tone

Excessive patient motion, the MRI scan sequence or electrical interference is causing noise in the

SpO2 system:

• Stop any patient motion, especially at the monitored site.

• Ensure that the module is placed outside of the MR bore.

• Ensure the clip (or grip) is positioned in a way that does not expose it to bright ambient light.

Non-Pulsat

SPO2 alarm flag area, blue

alarm light, INOP alarm

tone

The detected pulse is too weak for reliable reporting of SpO2 measurements:

• Check the patient’s condition.

• Check the clip (or grip) position and alignment on the patient then re-position or re-apply as

necessary.

• Try a different limb or site.

Probe Off

SPO2 alarm flag area, blue

alarm light, INOP alarm

tone

The SpO2 attachment is not properly applied to the patient. Reposition the clip (or grip) on the

patient.

Pulse?

SPO2 alarm flag area, blue

alarm light, INOP alarm

tone

Pulse reading is questionable. The SpO2 attachment may not be applied optimally or the tissue at

the application site may be too opaque:

• Check the alignment of the clip (or grip) on the patient.

• Try a different limb or site.

Searching

SPO2 alarm flag area, blue

alarm light, INOP alarm

tone

The SpO2 attachment was just applied or it has shifted position on the patient:

• If the clip (or grip) was just applied, allow about 20 seconds for the system to lock on to a good

pulse.

• Check the clip (or grip) position and reposition it if necessary.

• Replace the SpO2 probe.

If the message persists, contact technical support or authorized service personnel.

Wrong Prb

SPO2 alarm flag area, blue

alarm light, INOP alarm

tone

The probe attached to the wSpO2 module is not the correct type. Attach the correct probe to the

module.

Message, Location,

Indication

What to Do

Check CO2 Sampling

Line

CO2 alarm flag area, blue

alarm light, INOP alarm tone

Reduced flow has been detected by the CO2 system. Check the sampling line for pinches or

obstructions then clear any pinch or replace if necessary.

CO2 Cal Fail

CO2 alarm flag area, blue

alarm light, INOP alarm tone

CO2 failed to calibrate. Retry calibration.

If the message persists, contact technical support or authorized service personnel.

Message, Location,

Indication

What to Do

4‐34AlarmsExpressionMR400InstructionsforUse

CO2 Low Flow

CO2 alarm flag area, blue

alarm light, INOP alarm tone

Message may appear when the sampling line is initially connected; allow the a few seconds for the

flow to be established. Otherwise, the detected flow rate is 10 percent less than nominal; in this

case, check the sampling line for pinches or obstructions then clear any pinch or replace if

necessary.

If the message persists, contact technical support or authorized service personnel.

Check for CO2 Occlusion

CO2 alarm flag area, blue

alarm light, INOP alarm tone

Detected flow through the sampling line is less than 40 ml/min or the water trap may be full of

fluid:

• Check the sampling line for obstructions and replace it if necessary.

• Check the fluid level in the water trap and replace it if necessary.

If the message persists, contact technical support or authorized service personnel.

CO2 Out Of Range

CO2 alarm flag area, blue

alarm light, INOP alarm tone

The calculation value is greater than the upper CO2 limit. Perform readings to confirm patient’s

physiological condition.

If the message persists, contact technical support or authorized service personnel.

CO2 Sensor Faulty

CO2 alarm flag area, blue

alarm light, INOP alarm tone

CO2 bench detected a hardware or sensor error. Cycle AC mains power.

If the message persists, contact technical support or authorized service personnel.

CO2 Sensor Over Temp

CO2 alarm flag area, blue

alarm light, INOP alarm tone

The CO2 sensor is above the specified operating temperature. Confirm that the MR400 is

operating within the required environmental conditions (see Appendix A); if outside the specified

range, move the MR400 to an area that is within limits.

If the problem persists, stop all monitoring activities and contact technical support or authorized

service personnel.

CO2 Warming Up

CO2 alarm flag area, blue

alarm light, INOP alarm tone

CO2 is warming to operating temperature. Allow the process to complete, about 2 minutes.

CO2 Zero Required

CO2 alarm flag area, blue

alarm light, INOP alarm tone

Zero calibration of the CO2 module is needed; see page 7-15 for details.

Magnetic Field Too High

CO2 alarm flag area, blue

alarm light, INOP alarm tone

The gauss limit has been exceeded, and the AGENT option can no longer function. Position the

MR400 per the product labeling; see page 3-2.

HW Fail

CO2 alarm flag area, blue

alarm light, INOP alarm tone

CO2 module was not found during initialization. Cycle AC mains power.

If the message persists, contact technical support or authorized service personnel.

Low O2

AGENT alarm flag area, blue

alarm light, INOP alarm tone

The inspired O2 value has dropped below 18.0

Motor Speed Error

CO2 alarm flag area, blue

alarm light, INOP alarm

tone

The MR400 is too close to the MR magnet.

Ensure that the MR400 has been positioned correctly; see page 3-2. If the message persists, contact

technical support or authorized service personnel.

Message, Location,

Indication

What to Do

P1 (or P2)

Multiple Agents

AGENT alarm flag area, blue

alarm light, INOP alarm tone

More than one anesthetic agent gas was detected in a given breath phase, with a total MAC of the

detected mix is less than 3 MAC.

Note

If multiple agents have been detected with a total MAC of the detected mix greater than 3 MAC then

this message will be accompanied by a yellow alarm light and medium priority alarm tone.

O2 Sensor Not Present

AGENT alarm flag area, blue

alarm light, INOP alarm tone

Possible hardware failure associated with the O2 sensor. Ensure that the O2 sensor is secure in the

receptacle; see page 14-13.

If the message persists, contact technical support or authorized service personnel.

Occlusion

CO2 alarm flag area, blue

alarm light, INOP alarm tone

Occluded sample line detected at start up:

• Check the sampling line for obstructions and replace it if necessary.

• Check the fluid level in the water trap and replace it if necessary.

If the message persists, contact technical support or authorized service personnel.

O2 Sensor Fail

CO2 alarm flag area, blue

alarm light, INOP alarm

tone

O2 sensor has failed or expired. Replace the O2 sensor; see page 14-13.

If the message persists, contact technical support or authorized service personnel.

Occlusion at Start

CO2 alarm flag area, blue

alarm light, INOP alarm tone

Occluded sample line detected at start up:

• Check the sampling line for obstructions and replace it if necessary.

• Check the fluid level in the water trap and replace it if necessary.

If the message persists, contact technical support or authorized service personnel.

Performing CO2 Zero

CO2 alarm flag area, blue

alarm light, INOP alarm tone

Displayed while zeroing CO2. Allow the process to complete.

Persistent CO2 Occlusion

CO2 alarm flag area, blue

alarm light, INOP alarm tone

Reduced CO2 flow has been detected for over 2 minutes. Check for pinches or obstructions in the

sampling line. Clear any pinch, or replace the accessory if necessary.

If the message persists, contact technical support or authorized service personnel.

Message, Location,

Indication

What to Do

Catheter Disconnected

P1 (or P2) alarm flag area,

yellow alarm light, medium

priority alarm tone

The catheter cannot be detected. Check all catheter connections to and from the transducer.

Hardware Error

P1 (or P2) alarm flag area,

blue alarm light, INOP alarm

tone

A hardware error has been detected in the IBP system. Contact technical support or authorized

service personnel.

Message, Location,

Indication

What to Do

4‐36AlarmsExpressionMR400InstructionsforUse

TEMP

Transducer Faulty

P1 (or P2) alarm flag area,

yellow alarm light, medium

priority alarm tone

A electrical transducer malfunction has been detected.

• Check the transducer cable connection.

• Replace the transducer.

• Contact technical support or authorized service personnel if the message persists.

Transducer Not Present

P1 (or P2) alarm flag area,

yellow alarm light, medium

priority alarm tone

An IBP transducer was not found. Ensure that the transducer cables are connected to the

transducer and MR400.

If the message persists, contact technical support or authorized service personnel.

Message, Location,

Indication

What to Do

Cal Error

TEMP alarm flag area, blue

alarm light, INOP alarm

tone

Calibration error. Reconnect the sensor and then retry. Contact technical support or authorized

service personnel if the message persists.

Chk Probe

TEMP alarm flag area, blue

alarm light, INOP alarm

tone

The temperature sensor connection is bad, has a sharp bend, or is damaged:

• Ensure that the sensor is inserted completely in the temperature port on the patient

connection panel.

• Remove any sharp bends in the temperature sensor.

• If the message persists after performing the above actions, then the temperature sensor

most likely is damaged and readings cannot be provided. Try a new sensor.

Exp Probe

TEMP alarm flag area, blue

alarm light, INOP alarm

tone

The temperature probe connected to the MR400 is not the proper type. Insert the correct type of

temperature probe into the temperature port.

HW Fail

TEMP alarm flag area, blue

alarm light, INOP alarm

tone

Temperature hardware failure detected. Contact technical support or authorized service

personnel.

No Probe

TEMP alarm flag area, blue

alarm light, INOP alarm

tone

The temperature probe is not properly connected to the MR400. Insert a temperature probe into

the temperature port on the patient connection panel.

Wrong Prb

TEMP alarm flag area, blue

alarm light, INOP alarm

tone

The temperature probe connected to the MR400 is not the proper type. Insert the correct type of

temperature probe into the temperature port.

Message, Location,

Indication

What to Do

NIBP

Message, Location,

Indication

What to Do

Communication Error

NIBP alarm flag area, blue

alarm light, INOP alarm tone

An internal NIBP error has occurred. Discontinue use of NIBP and contact technical support or

authorized service personnel.

Deflation Timeout

NIBP alarm flag area, red

alarm light, high priority

alarm tone

Cuff deflation has timed out; displayed if the NIBP cuff deflation period is greater than 80 seconds

(neonatal patient type) or is greater than 150 seconds (adult and pediatric patient types):

• Check the patient.

• Check for proper cuff size and placement.

• Check the cuff and hoses for pinching.

If the message persists, contact technical support or authorized service personnel.

Hardware Error

NIBP alarm flag area, blue

alarm light, INOP alarm tone

NIBP hardware failure detected. Discontinue use of NIBP and contact technical support or

authorized service personnel.

Inflation Timeout

NIBP alarm flag area, blue

alarm light, INOP alarm tone

Cuff inflation has timed out:

• Check the patient.

• Check the cuff and hoses for pinching or leaks.

If the message persists, contact technical support or authorized service personnel.

Measurement Failed

NIBP alarm flag area, blue

alarm light, INOP alarm tone

The NIBP measurement has failed:

• Check the patient.

• Check for proper cuff size and placement.

• Check the cuff and hoses for pinching or leaks.

If the message persists, contact technical support or authorized service personnel.

Measurement Timeout

NIBP alarm flag area, blue

alarm light, INOP alarm tone

The NIBP measurement has timed out:

• Check the patient.

• Check for proper cuff size and placement.

• Check the cuff and hoses for pinching or leaks.

Check the cuff condition and placement on the patient.

Module Not Calibrated

NIBP alarm flag area, blue

alarm light, INOP alarm tone

NIBP is not calibrated. Contact technical support or authorized service personnel.

Over Pressure

NIBP alarm flag area, blue

alarm light, INOP alarm tone

The allowed pressure for the type of patient has been exceeded:

• Ensure that the patient is immobilized and not applying pressure to the cuff.

• Check the cuff condition and placement on the patient.

• Make sure that the hose is not pinched.

If the message persists, contact technical support or authorized service personnel.

Pressure Correction

NIBP alarm flag area, blue

alarm light, INOP alarm tone

A pressure correction error has been detected:

• Ensure that the patient is immobilized and not applying pressure to the cuff.

• Check the cuff condition and placement on the patient.

Residual Pressure

NIBP alarm flag area, blue

alarm light, INOP alarm tone

Residual pressure remains in the NIBP system. Disconnect the NIBP hose from the patient

connection panel and then restart the procedure.

4‐38AlarmsExpressionMR400InstructionsforUse

Other Status Indications

Message, Location,

Indication

Condition

All Alarms Are Off

System message area, no

alarm light, no alarm tone

All alarm limits have been turned off.

Audio Off

System message area, no

alarm light, no alarm tone

Alarm sound is silenced.

Audio Paused

System message area, no

alarm light, no alarm tone

Alarm sound is paused.

Change NIBP Cuff

System message area, no

alarm light, no alarm tone

The Patient Type was changed so the NIBP cuff should be changed.

Check Alarm Vol

System message area, no

alarm light, no alarm tone

Power was just turned on, settings were recalled.

status information pane, blue

alarm light, INOP alarm tone

The charge level is low for the wECG module battery (or batteries). Install at least one charged

battery into the wECG module.

WARNING

A red battery symbol indicates that the module batteries have fallen below

the required operational output and module shutdown with loss of

monitoring will occur. Immediately replace the module batteries to avoid a

loss in monitoring.

Status information pane, no

alarm light, no alarm tone

No communication between the MR400 and wECG module. Ensure that the wECG module is set

to the same network channel as the MR400 cart. If both are the same, use an alternate setting.

If the indication persists, contact technical support or authorized service personnel.

ECG Test Signal

System message area, no

alarm light, no alarm tone

The ECG Test Signal is on.

Status information pane, no

alarm light, no alarm tone

No communication between the MR400 and IP5. Ensure that the IP5 is set to the same network

channel as the MR400 cart. If both are the same, use an alternate setting.

If the indication persists, contact technical support or authorized service personnel.

Status information pane, blue

alarm light, INOP alarm tone

Charge level of the cart batteries is low. Connect the MR400 cart to external power and allow the

batteries to charge.

WARNING

A red battery symbol indicates that the main batteries in the MR400 have fallen

below the required operational output and system shutdown with loss of monitoring

will occur. Immediately locate an AC outlet and connect the MR400 to avoid a loss in

monitoring.

Overscale

ECG alarm flag area, no

alarm light, no alarm tone

The size of the ECG waveform is too large and the tops of the ECG waveforms are clipped (that is,

cut off). Reduce the size using the Scale setting; see page 5-28.

Real Tones Disabled

System message area, no

alarm light, no alarm tone

Normal audio sounds are suspended as a volume adjustment is in progress.

Simulation

System message area, no

alarm light, no alarm tone

The system is in simulation mode. Turn off power to exit this mode.

Status information pane, blue

alarm light, INOP alarm tone

Charge level of the wSpO2 module battery is low. Install a charged battery into the wSpO2 module.

WARNING

A red battery symbol indicates that the module batteries have fallen below

the required operational output and module shutdown with loss of

monitoring will occur. Immediately replace the module batteries to avoid a

loss in monitoring.

Status information pane, no

alarm light, no alarm tone

No communication between the MR400 and wSpO2 module. Ensure that the wSpO2 module is set

to the same network channel as the MR400 cart. If both are the same, use an alternate setting.

If the indication persists, contact technical support or authorized service personnel.

Message, Location,

Indication

Condition

4‐40AlarmsExpressionMR400InstructionsforUse

CHAPTER 5

Monitoring ECG

Electrocardiogram(ECG)monitoringinsidetheMRIenvironmentisuniqueandrequires

additionalprecautionstopermitsafepatientprocedures.Itisalwaysimportanttoremember

thattheriskofradiofrequency(RF)heatingiseverpresentwhenanyelectricalconductors(for

example,ECGleadcables)areplacedintheMRsystembore.Byfollowingtheoperating

precautions,warningsandtheguidelinesbelow,theseriskscanbeminimized.TheECG

parameterisintendedforECGmonitoringmodeandnotdiagnosticECGmonitoring.

WARNINGS

•The MR400 is not intended for use with patients using pacemakers or electrical

stimulators.

• Arrhythmias, erratic heartbeats, operation of electrical stimulators, pacemakers and

patient motion can result in inaccurate readings. Rate meters may continue to count

pacemaker rates during occurrences of cardiac arrest or some arrhythmias. Do not

rely entirely upon rate meter alarms. If questionable readings are obtained, check the

patient's vital signs by alternate means before administering medication.

CAUTION

Pacer pulses are not specifically rejected by the MR400 and may be treated as part of MRI

gradient noise. Gradient filtering attempts to remove high frequency pulse-shaped waveforms

from the ECG signal which may resemble pacer waveforms, and it is possible that the pacer

waveform may be removed with the gradient noise.

ECG Monitoring Considerations for the MR Environment

MonitoringECGintheMRenvironmentisparticularlychallengingbecauseoftheinherent

distortionoftheECGwaveformcausedbythecombinedelectromagneticfieldsgeneratedbythe

MRIscanner.Inparticular,certainECGinterferenceappearswhenthepatientisplacedinsidethe

borebeforescanningbegins.ThesebloodflowinduceddistortionsoftheECGareduetothe

largeamountofbloodmovingthroughthevesselsoftheheart(aorta).Blood(averygood

electricalconductor)movingthroughthelargemagneticfieldoftheMRproducesanelectrical

potentialthataddstotheECGsignal.Thisinducedelectricalpotentialisseenprimarilyasan

augmentationoftheECGT‐waveamplitude,althoughothernon‐specificwaveformchangesare

alsoapparentontheECG.SinceanelevatedT‐waveorSTsegmentwillbeassociatedwithtrue

physiologicdisorders,thestaticmagneticfield‐inducedECG‐distortionsmayprohibiteffective

ECGmonitoringintheMRI.Forthisreason,abaselinerecordingoftheECGpriortoslidingthe

patientinsidetheboreoroutsidetheMRmagnetroomwillbenecessary.

5‐2MonitoringECGExpressionMR400InstructionsforUse

TheproperplacementoftheECGelectrodesintheMRIiscriticaltoreducingthebloodflow

induceddistortionoftheECGwaveform.WithproperstrategicplacementoftheECGelectrodes

andminimizationofECGleadcablelength,thisbloodflowinduceddistortioncanbekepttoa

minimum,asdiscussedinthissection.Additionalartifactscausedbythestatic,gradientandRF

electromagneticfieldscanseverelydistorttheECG,makingobservationofthemorphologic

changesanddetectionofarrhythmiaquitedifficult.MonitoringusingadifferentECGleadview(I,

II,III,AVL,AVR,AVF)willminimizesomeoftheseartifacts.

wECG Module and ECG Lead Cable

ThewECGmoduleandleadcableareintendedforpatientuseswhencontinuousECGmonitoring

orcardiacgatingarerequired.ThewECGmoduleandleadcablemaybeusedintheMRsystem

bore,althoughthemodulemustnotbeplacedwithin28cm(11inches)oftheMRIfieldofview

(FOV).ForwECGmoduledetails,seepage2‐9.ThecomponentsoftheECGleadcablearedetailed

below.

CAUTIONS

• If dropped, the wECG module must be verified for correct operation before use; see page

14-12.

• Guard against the accidental ingress of liquid into the module, as measurements made by the

device can be adversely affected.

Note

Refer to your facility's biohazard procedure for disposal of ECG lead cables when they become

unusable. Usually cables are disposed of as medical waste per facility procedures.

1Connector

2ECG lead cable label identifier

3Velcro storage strap

4Cable trunk with foam insulator

5Lead wires

6Lead cable clips

123

4 5

Quadtrode Electrodes

TheQuadtrodeelectrodesserveaspatientconnectionpointsfor

theECGleadcableclips.DifferentQuadtrodeelectrodesare

availabletomeeteachmonitoringrequirement.The

componentsofaQuadtrodeelectrodearedetailedbelow.

Work Flow for ECG Monitoring

WhenmonitoringECG,manyfactorswillimpacttheperformanceandoperationofthe

parameter,including:

•Thesiteselectedonthepatient,

•TheECGleadcableandQuadtrodeelectrodepairing,

•Theselectedfilterandleadviewsettingforthemonitor,

•ModuleplacementandECGleadcablerouting;and,

•ScansequenceselectionandscansequenceparametersontheMRIconsole.

ToprepareapatientforECGmonitoring

1Foam insulator

2Electrode contact (four contacts are

provided on the standard and neonatal

types, and one contact on the CV type

3Lead retainer (not present on CV and

neonatal types)

Step Action

1 SelectthePatientType.

SeeSelectingthePatientTypeonpage3‐11.

2 Accordingtothepatienttype,theirbodymass,andthestudytobe

performed,choosearecommendedECGleadcableandQuadtrode

electrodepair.

SeeSelectingtheECGLeadCableandQuadtrodeElectrodeTypeon

page5‐5.

3Decide

wheretoapplytheQuadtrodeelectrodetothepatient.

SeeIdentifyingthePlacementSitefortheQuadtrodeElectrodeon

page5‐7.

5‐4MonitoringECGExpressionMR400InstructionsforUse

4Preptheplacementsite(s)onthepatientandthenapplythe

Quadtrodeelectrodetothepatient.

SeePreparingtheQuadtrodeElectrodeSiteonpage5‐11.

5 AttachtheleadcableclipstothecontactsontheQuadtrode

electrode.

SeeAttachingtheECGLeadCableonpage5‐12.

6EvaluatetheECGsignalstrengthandmakeadjustmentsasneeded

beforethepatiententersthescanner.

SeeCheckingtheECGSignalStrengthonpage5‐16.

7 Positionthepatient,theleadcableandthewECGmodulefor

scanning.

SeePositioningtheECGLeadCableandwECGModuleforScanning

onpage5‐19.

8 SelecttheleadviewandFilterModeforthestudy.

SeeChangingtheLeadViewonpage5‐17andFilterModeonpage

5‐31.

9Beforeslidingpatientinsidethebore,oroutsidetheMRmagnet

room,establishabaselinerecordingofthepatient’sECGsignal.

10 Slidethepatientintothebore,butdonotstartscanning.Then,

rechecktheECGwaveformforusabilitybyevaluatingitfor

distortion.

IfECGwaveformhasbecomeexcessivelydistortedandtheheart

ratenumericisnotfunctioningproperlyinthebore,thentheECG

leadcablemayrequirereroutingand/oranewelectrode

placementsitemustbeselectedbeforestartingthescansequence.

(AlsoseeMinimizingECGWaveformNoiseonpage5‐18.)

Step Action

Selecting the ECG Lead Cable and Quadtrode Electrode Type

ECGleadcablesandQuadtrodeelectrodesareprotonemissionscompliant,willnotdistortthe

MRimage,andaredesignedtoprovidethemaximumpatientsafetyandMRIperformance:

•OnlyusethespecifiedECGleadcableswiththeMR400,asthesearespeciallyconstructed

toavoidpatientheatingbyreducingtheamountofradiofrequency(RF)energythatcan

flowthroughthewiresandwithashorterlengthtoreducethepotentialforcablelooping.

ThetypeofleadcableneededwilldependuponthetypeofQuadtrodeelectrodebeing

used.

•OnlyusethespecifiedQuadtrodeelectrodewiththeMR400,asthiswillminimizethe

possibleriskofelectrodeheatingduringMRIproceduresandreducetheamountofMRI‐

generatedartifactsontheECGwaveform.ThetypeofQuadtrodeelectrodeneededwill

dependgenerallyuponthepatienttype,genderandweight.(Regardlessofthetype,the

Quadtrodeelectrodewillbeconsideredasingleitemwhendiscussedinthistext.)

11 BeginscansequenceandobservetheECGwaveform.

IftheECGwaveformbecomescompromisedduringscanning,then

changetheleadviewand/ortheFilterModeontheMR400.

Note

ECG performance during MRI scanning can be further improved by

modifying scan sequence parameters at the MRI console. Changing

any of these parameters directly alters image quality so precaution

must be taken to not overwhelmingly affect the desired image

characteristics:

• Increase TE (Echo Time)

• Increase TR (Repetition Time)

• Increase TI (Inversion Time)

• Increase / change the imaging plane (for example, sagittal to

axial)

• Turn off fat suppression

• Decrease the PNS level

• Decrease the gradient strength

12 Afterscanning,disconnectthewECGmodulefromthepatient.

ThenstorethewECGmoduleinthemoduleholder.Loopthecable

trunkwithfoaminsulatorthensecureitusingtheVelcrostorage

straptokeeptheexcesscablelengthfromtouchingthefloor;see

page2‐12.

Step Action

5‐6MonitoringECGExpressionMR400InstructionsforUse

ThetablebelowhighlightstherecommendedusesofECGleadcablesandQuadtrodeelectrodes.

ECG Lead Cables and Quadtrode Electrodes - Recommended Pairings

CV ECG lead cable CV Quadtrode Electrode

Purpose:

• For patients weighing more than 10 kg (22 pounds)

• Best for female and overweight patients (that is, in situations where placement

would be difficult using the standard Quadtrode electrode)

Version and Part Number:

AAMI: REF 989803193721

IEC: REF 989803193751

Part Number:

REF 989803179041

Standard ECG lead cable Quadtrode Electrode

(standard)

Purpose:

• For patients weighing more than 10 kg (22 pounds)

• Quick application

Version and Part Number:

AAMI: REF 989803193731

IEC: REF 989803193761

Part Number:

REF 989803179031

Neonatal ECG lead cable Neonatal (Neo)

Quadtrode Electrode

Purpose:

• For infants weighing less than 10 kg (22 pounds)

• Quick application

Version and Part Number:

AAMI: REF 989803193741

IEC: REF 989803193771

Part Number:

REF 989803179051

Identifying the Placement Site for the Quadtrode Electrode

Warning

WARNING

Ensure that the location of the electrodes is compliant to the requirements of your

electrosurgical equipment to reduce the possibility of burns; however, note that monitoring

in the MR environment requires specific electrode placement. (See page 5-3 to ensure the

highest quality ECG signal. For questions and guidance regarding placement, contact

technical support; see page 14-16 for contact information.)

Accordingtothepatienttypeorweight,placementoftheQuadtrodeelectrodeovertheheartis

importantforoptimalECGperformance.

Note

For placement purposes, we define to the breast line as an imaginary horizontal line that extends

across the nipple areas of a patient of normal weight.

Adultandpediatricpatients:

•IfusingastandardQuadtrodeelectrode,placeitslightlytotheleftofthepatient’s

sternum,withthetoptwoelectrodesonthebreastlineandthebottomtwoelectrodes

belowthebreastline.

•IfusingaCVQuadtrodeelectrode,attempttokeepasmallseparationbetweenindividual

electrodes—adistancethatiswideenoughtoproperlycapturetheECGvector,butnotso

wideastocauseexcessivenoisepickup.(Increasingtheloopareabetweenelectrodeshas

anegativeeffectonECGqualityuniquetotheMRIenvironmentthatcausesmorenoiseto

bepickedupbytheECGleads).

Neonatalandinfantpatients:

• Dependingonthepatient’sweight,centerastandardQuadtrodeelectrodeoraneonate

Quadtrodeelectrodeoverthesternumandthebreastline.

DeviationsfromtheguidelinesforQuadtrodeelectrodeplacementcanaffecttheproducedECG

signalasfollows:

•Placementsoffsetabovethebreastline:IncreasestheT‐waveamplitudeandthe

susceptibilitytostaticfield(B0)effects.

•Placementsoffsetbelowthebreastline:DecreasestheT‐waveamplitude,increasethe

distancefromtheaorticvalve,thesusceptibilitytostaticfield(B0)effectsandtheECG

waveamplitude.

•Placementsclosertothesternum:IncreasestheECGwaveamplitudeandalsoany

respiration‐inducednoise.

•Placementsfartherfromthesternum:DecreasestheECGwaveamplitudeandany

respiration‐inducednoise.

5‐8MonitoringECGExpressionMR400InstructionsforUse

ThediagramsbelowillustrateQuadtrodeelectrodeplacementsite(s)accordingtopatienttype,

includingthepreferredQuadtrodeelectrodetypeandlocationfordifferentpatientbodysizes.

Selectingsitesonadultfemalepatients

*Where grayed images indicate placement sites against the ribcage under the breast.

Average weight adult female* Overweight adult female*

CV Quadtrode

Preferred

CV Quadtrode

Preferred

Standard Quadtrode Standard Quadtrode

Selectingsitesonadultmalepatients

*Where the grayed image indicates a placement site against the ribcage under the breast.

Average weight adult male Overweight adult male*

CV Quadtrode CV Quadtrode

Preferred

Standard Quadtrode

Preferred

Standard Quadtrode

5‐10MonitoringECGExpressionMR400InstructionsforUse

Selectingsitesonpediatricpatients

Pediatric female Pediatric male

CV Quadtrode CV Quadtrode

Standard Quadtrode

Preferred

Standard Quadtrode

Preferred

Selectingsitesoninfantsandneonatalpatients

Preparing the Quadtrode Electrode Site

ProperpreparationfortheapplicationoftheQuadtrodeelectrodeiscriticaltoECGperformance.

TheresultofpoorapplicationpreparationwillbepoorECGmonitoringperformance.Ifelectrode

contactwiththeskinispoor,thenremoveanddiscardtheQuadtrodeelectrode,andrepeatthe

sitepreparationprocessagainaccordingtotheinstructionsbelow.NeverreuseaQuadtrode

electrodebecauseitwillnotsecurelyadheretotheskin.

ToprepareaQuadtrodeelectrodesiteonapatient

Infants and Neonates

Standard Quadtrode Neonatal Quadtrode

Step Action

1ChecktheexpirationdateoftheQuadtrodeelectrodepackage.

2 Selecttheapplicationarea(s),avoidingtheareolaandnipplewhen

possible,fortheQuadtrodeelectrodesite(s)asprovidedonpage5‐

7.

5‐12MonitoringECGExpressionMR400InstructionsforUse

Notes

• The ECG Skin Prep gel contains light abrasive pumice and saline that clean and enhance

the conductive properties of the skin, thus enhancing ECG performance. This practice also

helps remove ambient artifacts.

• Isopropyl/rubbing alcohol must not be used to prep the site as it breaks down the conductive

properties of the skin, thus degrading ECG performance.

Attaching the ECG Lead Cable

WARNINGS

• Never use any ECG lead cables other than the specified ECG lead cables.

• High levels of RF energy may cause patient heating or burns.

• An ECG lead cable that becomes inadvertently looped during an MRI examination

may act as conductive lines for RF induced currents, resulting in excessive heating and

possible burns. When lead cables or other cables form a conductive loop in contact

with the patient's tissue, minor to severe burning can result. Please refer to the

additional information in Appendix E to prevent excessive heating associated with

MRI procedures. Follow steps to minimize the risks of MRI-related heating on page 5-

20.

Giveninrelationtothepatient’slimbs,designatorsandcolorsoftheECGleadcableclips

referenceconnectionlocationsontheQuadtrodeelectrode.Also,notethatdependinguponthe

leadcableversion,AAMI(AssociationfortheAdvancementofMedicalInstrumentation)orIEC

(InternationalElectrotechnicalCommission),differentdesignatorsandcolorsareusedforthese

references.ThediagramsbelowillustratetheleadcableattachmentlocationstotheQuadtrode,

accordingtotheECGleadcableversionandlimb.

Step Action

3Ifnecessary,shavetheapplicationareatoremovehairfromthe

selectedQuadtrodeelectrodesite(s).

4ApplyECGSkinPrepGel(REF989803152291)toagauzepad.

5Briskly

rubtheselectedsite(s)withthegauzepad(theskinmay

turnpink).

6 Removeanyexcessgelwithacleangauzepad.

7PlacetheQuadtrodeelectrodeatthepreparedsite(s)onthe

patient.

CAUTION

ECG lead cable clips should not be placed on the patient’s extremities.

ToattachtheECGleadcabletothewECGmoduleandthentotheQuadtrodeelectrode

contacts

AAMI ECG Lead Cable

Connections

IEC ECG Lead Cable

Connections



AAMI ECG Lead Cable Clip

Designator / Color

IEC ECG Lead Cable Clip

Designator and Color Associated Limb

RA / White R / Red Right arm

RL / Green N / Black Right leg

LA / Black L / Yellow Left arm

LL / Red F / Green Left leg

Step Action

1InserttheconnectoroftheECGlead

cableintothecableportonthewECG

module.

CAUTION

When inserting or removing the lead

cable, only use the connector as a

finger-hold; never pull or apply

excessive force to the wires.

5‐14MonitoringECGExpressionMR400InstructionsforUse

2 DependingupontheECGleadcabletype,attachtheclipstothe

Quatrodeelectrodecontacts,asshownintheappropriate

connectiondiagramonpage5‐12.Squeezeeachclipopenthen

placetheclipontotheelectrodecontactandrelease.

CAUTION

When inserting or removing the clip leads, use the clip as the finger-

hold; never pull or apply excessive force to the wires.

3IfusingastandardQuadtrodeelectrode,securetheleadcable

wiresusingtheleadretainer.

Seepage5‐3forthelocation.

4CheckthebatteryindicatorsonthewECGmoduletoensurethat

enoughchargeexistsinatleastoneoftheinstalledbatteries:

• Greenbatteryindicator=Chargesufficient;proceedtostep6.

•Redbatteryindicator=Chargelow;proceedtostep5.

Seepage2‐9fordetails.(Also,youcanreferencethestatus

informationpane;seepage2‐16.)

5 Accordingtotheredbatteryindicator(s)presentonthewECG

module,insertachargedmodulebatteryintothecorresponding

batterybay(s)andthenrecheckthebatteryindicator(s)toensurea

sufficientchargebeforeproceeding;seepage1‐24.

6CheckthenetworkchannelindicatoronthewECGmoduleto

ensurecommunicationisestablishedwiththeMR400:

• Steady=Goodcommunication;proceedtostep8.

• Flashing=Nocommunication;proceedtostep7.

Seepage2‐10fordetails.(Also,youcanreferencethestatus

informationpane;seepage2‐16.)AninoperativeECGparameteror

wECGmoduleisindicatedbyabsenceofanECGwaveformanda

simultaneousLeadFailalarm.

7EnsurethatthewECGmoduleiswithin9.1m(30feet)ofthe

MR400,inthesameMRIroomorinthesameshieldedroom,andis

settothesamewirelessnetworkchannelusedbytheMR400;see

page1‐29.

Step Action

Lead Fail Indication

LeadFail(illustratedbelow)isanINOPalarmthatwillbedisplayedwhentheECGtracecanno

longerbeproducedbecauseoneoftheelectrodesrequiredformeasurementisdisconnected—

eitheranelectrodecameoffofthepatient,anECGleadcableclipcameoffoftheelectrode,ora

wireintheECGleadcablehasfailed.DependingupontheTraceALead(orTraceBLead)setting

(seepage5‐27),theelectrodefaultindicator(s),LL,LA,orRA,maybedisplayedintheECGVSbox

(seetheexamplebelow);seepage4‐31formoreinformation.

Warning

WARNING

Failure to respond to a Lead Fail alarm will result in a lapse of patient monitoring.

8EnsurethattheECGsignalhasthenecessaryamplitudebychecking

thedisplayedwaveform;seeCheckingtheECGSignalStrengthon

page5‐16.

IfLeadFailisdisplayed,seepage5‐15fortroubleshootingdetails;

or,ifLeadSaturationisdisplayed,replacetheQuadtrode

electrode,seepage5‐11.

Note

During a Lead Fail condition, if the HR Source is set to ECG, then no HR

measurement numeric will be displayed in the ECG and SPO2 VS

boxes; see page 5-15 for an example.

9 KeepthemoduleoutsidetheMRsystemborebyplacingitinone

ofthetwolocationsshowninPositioningtheECGLeadCableand

wECGModuleforScanningonpage5‐20.

Step Action

1Lead Fail message indication

2Electrode fault indication, example

5‐16MonitoringECGExpressionMR400InstructionsforUse

Checking the ECG Signal Strength

EvaluatetheECGsignalproducedbythepatientbeforeentryintotheMRIscanner,the

optimumtimetocorrectanyproblem.

Aminimumsignalstrengthshouldbepresent,asweakersignalsmaybepronetogradient

interference:

• SelectScaletoadjustthedisplayedsizeofthewaveform(s),wherethescaleindicator

provides,a1millivolt(mV)referenceatanygivensetting;seeSelectingtheScale,below).

• SelectTraceALead(orTraceBLead)toadjusttheconfigurationoftheleadsusedforECG

signaldetection,wherethebestsignalstrengthisindicatedbythedisplayedpeak‐to‐peak

amplitudeoftheQRScomplex,whichshouldbeatleast1mV(thatis,thewaveform

shouldbeequaltothesizeofthescaleindicator).Insomecases,a1mVECGsignalcannot

beachievedduetopatientphysiology.Inthesecases,trytoachievethelargestamplitude

attainable.SeeChangingtheLeadView,onpage5‐17.

Selecting the Scale

TheScalesettingonlychangeshowtheECGtraceappearsonthescreen—increasingor

decreasingthewaveformandanyartifacts.ToincreasetheamplitudeoftheQRScomplex,refer

toChangingtheLeadViewonpage5‐17.

TochangetheSCALEsetting

Scale indicator

QRS complex

Step Action

1EnsurethatthecorrectPatientTypehasbeenselected;seepage3‐

11fordetails.

2 SelecttheECGVSbox.

TheECGmenuappears.Currentsettingsaredisplayed.

3 SelectScale.

TheScalemenuappears;seepage5‐28.

Changing the Lead View

IftheQRScomplexdoesnotequalaminimumof1mVpeak‐to‐peak,thencompletethe

followingstepstomakethewaveformamplitudeincrease.

Tochangetheleadview

4 Selectthesetting.Onlyasettingof5xor10xisrecommended.

Auto

10x

15x

20x

25x

30x

40x

Thesettingisapplied.

5Takenoteofthescaleindicator;seepage5‐22.Iftheselectedscale

resultsinanECGtracesolargethatthewaveformpeaksare

distortedorclipped,Overscalewillbedisplayed.Inthiscase,select

anothersettingtoresizethewaveformuntilthemessagestops.

Step Action

1VerifythataQuadtrodeelectrodeorQuadtrodeelectrodesare

beingused,andverifytheexpirationdate,qualityandpackaging

fortheelectrode.

2EnsurethatthepreferredQuadtrodeelectrodeisbeingused;see

page5‐5.

3Ensurethatthesuggestedplacementsite(orsites)isbeingused;

seepage5‐7.

4 SelecttheECGVSbox.

TheECGmenuappears.Currentsettingsaredisplayed.

5 Dependinguponthetracebeingexamined,selectTraceALeador

TraceBLead.

Therespectivemenuappears.Thecurrentsettingishighlighted.

5‐18MonitoringECGExpressionMR400InstructionsforUse

Minimizing ECG Waveform Noise

NoisecanrenderanECGwaveformunusable,asshownintheexamplebelow.

ManycausescanresultinanoisyECGwaveform,including:

•Useofalcohol‐basedproductsduringpatientprep.

•UseofaQuadtrodeelectrodethatisexpiredordried‐out.

•UseofwrongordamagedECGcableleads.

•ImproperplacementoftheQuadtrodeelectrode.

•PlacingtheMR400insidethe5000gaussline.

•PlacingthewECGmoduleinsidethebore.

•MRvibrationsaffectingthewECGmodule.

• Incorrectnotchfiltersetting;seepage5‐22.

6 Selectthedesiredleadviewsetting.

II

III

AVL

AVR

AVF

Thesettingischanged.

Note

When presented with poor gating or heart rate performance, it may

be necessary to use the Pediatric ECG setting; see page 5-32.

7Iftheamplitudedidnotimprove,repeatstep5andcyclethrough

theremainingleadviewsettingsuntila1mVsignalamplitudeis

attained.

8Iftheamplitudedidnotimprove,removetheECGleadcableand

theQuadtrodeelectrode.Thenpreptheapplicationsiteagainand

applyanewQuadtrodeelectrode.

Step Action

• SelectingMonitorastheFilterModeforthescansequence;seepage5‐31.

•Scansequenceparameters.

•ImproperconnectionofECGleadcabletoQuadtrodeelectrodecontactlocations.

•RoutingtheECGleadcableadjacenttothebodycoilorunderneathanextremitycoil.

• ExcessivedistancebetweenelectrodeswhenusingCVQuadtrodeelectrodes.

Positioning the ECG Lead Cable and wECG Module for Scanning

WARNINGS

• When applying electrodes or connecting the ECG lead cable, ensure that the electrodes

or connectors never contact other conductive materials including grounded

conductors. In order to prevent contact with other conductors or earth ground, make

sure all the electrodes or connectors are properly attached to the patient.

• No other electrical conductors (e.g. wires, leads, probes, et cetera) should be placed

within the MRI bore at the same time as the ECG lead wires. Electrode heating risk

increases when multiple conductive cables and probes are placed in the bore with the

patient. Mixing of conductors from various manufacturers (catheters, temperature

sensors, et cetera) is not recommended. Multiple electrical conductors within the MRI

bore can allow cross-coupling between these various conductors, and appear as a large

antenna for RF energy pick-up, which will result in electrode heating, and possibly

skin burns. It is always important to identify if the patient has any metallic wires,

conductors, implants, stents, et cetera. within their body which will act as cross-

coupling conductors. If these are present, ECG monitoring may not be able to be

performed without experiencing electrode heating. Non-conductive tubes, air-lines, et

cetera—including NIBP cuffs and hoses, EtCO2 and/or oxygen air-lines, and SpO2

probes—can be used safely as these items do not include electrically conductive

materials. The MR400 has been validated for use with all accessories specified in the

accessory list; see page 1-33.

• Circular, U-shaped or S-shaped loops in the ECG lead cable should be avoided to

reduce the risk of heating.

• Do not use the Velcro storage strap to loop the ECG lead cable during MR scanning;

otherwise, there is a risk of cable heating and possibly skin burns.

5‐20MonitoringECGExpressionMR400InstructionsforUse

PositioningtheECGleadcable

PositionandkeeptheECGleadcablesinastraightline.Never

allowtheECGleadcablestotouchtheMRsystembore.Any

loop(circular,U‐shaped,S‐shaped)inthecablesorcable

contactwiththeMRsystemborewillcauseheatinginthe

cablesorinthepatientelectrodes.Followthestepsbelowto

minimizethecableheatingrisk.

TominimizetheriskofMRI‐relatedheating

Step Action

1ArrangetheECGleadcableandtheclipleadsneatly,inastraight

alignment,withnolooping.

2Avoidcontactbetweencablesandbareskin.CushionthewECG

module.

3UseonlytheECGleadcablesdesignatedforusewiththisproduct;

seepage1‐35.

4 Minimizetheuseofmultiplecables.(Seethewarningsonpage5‐

19fordetails.)

5ThewECGmodule,ECGleadcablesandQuadtrodeelectrodeare

acceptableforusewithinMRsystemswithstaticmagneticfield

strengthsof3.0Tesl a orlesswithintheMRsystemboreusingaMR

systemreportedwholebodyaverageSpecificAbsorptionRates

(SAR)upto4.0W/kg.EnsurethatB1rms<7.2μT.

6 MonitoringofECGatpowerlevelsofgreaterthanaMRsystem

reported,wholebodyaveragedSARof4W/kgisnotrecommended

forthegeneralpatientpopulation.Suchmonitoringmustonlybe

attemptedwithconsciouspatientswithnormalthermoregulatory

capabilitiessothattheymaywarnyouofpossibleexcessiveheatat

themonitoringsites.

7Usecautionforscantimes(thatis,perpulsesequence)greater

than15minutes.ForMRIscanswithaverageSAR>1W/kg,limit

scantimeto15minutesandpauseatleast3minutesbetween

scanstoallowtheECGelectrodestocool.

8Duringmeasurement,checkthepatienttoensurethatMRI‐related

heatingisnotoccurring.

PositioningthewECGmodule

Warning

WARNING

The wECG module must be kept outside the system bore or image distortion may result.

This is a result of proton emissions from the ECG module.

Dependinguponyourregionofinterest(ROI)andthelargestfieldofviewbeingexamined(see

illustrationbelow),followtheseguidelinestoensurethebestperformanceofthewECGmodule,

especiallyduring harshscansequences:

•Forstaticfield(B0)compliance,keepthemoduleatleast28cm(11inches)outsidethe

MRIfieldofview.

• Consideringthescantobeperformed,placethemoduleonornearthepatientandas

closetotheboreiso‐centeraspossible.

•Placethemoduleasclosetotheboreopeningaspossible.(Ifthemodulecanbeplaced

outsidethebore,positioningattheboreiso‐centerisnotnecessary.)

•PlacethemoduleonacushionedsurfacetominimizeMRvibrations.

Magnet type: Achieva 3.0T XR Series

Male:

ROI

Largest FOV

(45 cm)

Bore Iso-center

Patient Table

MRI Bore

Male:

Patient Table

MRI Bore

Bore Iso-center

For B0 compliance always keep the

wECG module 28 cm from the edge

of the FOV.

For example, a lower abdomen scan

places the module at an acceptable

distance of 30 cm (considering the

length of the ECG cable)

5‐22MonitoringECGExpressionMR400InstructionsforUse

Warning

WARNING

If the wECG module is positioned incorrectly when used within the MR magnet room, the

following factors may cause ECG waveform distortion and numeric inaccuracies:

• Fast magnetic field changes usually found with, but not limited to, scan sequences

using Peripheral Nerve Stimulation (PNS) levels above 80 percent.

• Severe vibrations induced by scan sequences using PNS levels above 80 percent.

• The distance from the bore iso-center in the x, y, or z directions.

Selecting the Filter Mode

ChoosetheappropriateECGfiltermodeforyourMRIstudy;seepage5‐31formodedetails.

Tochangethefiltermodesetting

ECG Waveforms and VS Box

TheECGmeasurementisdisplayedaswaveformsintheVStraceareaofthescreenandas

numericinformationintheECGVSbox.Otherdata,includingECG‐relatedalarminformation,are

alsoprovidedinthisareaofthescreen,asdetailedbelow.

Step Action

1PresstheECGFilterkey.

TheFilterModemenuappears.Thecurrentsettingishighlighted.

2 Selectthedesiredfilter.

Monitor

Default

Advanced1

Advanced2

Thesettingisapplied,asindicatedinECGVSbox.

Item Name Definition

1 ECG VS waveform Is the ECG waveform (Trace A, when enabled)

Note

To change the waveform speed, see Sweep Speed on page 3-25.

2 Alarm flag area Displays ECG alarm flags when detected; see page 4-31.

3 ECG VS box label Indicates the ECG vital sign parameter, and accesses the ECG menu

4 Unit of measure Indicates that the heart rate numeric is given in BPM (beats per minute)

5 Heart rate numeric Is the patient’s detected heart rate measurement

6 Magnet indication Indicates Magnet Filter when engaged.

7 HR upper alarm limit Is the upper limit setting for the heart rate alarm, and accesses the HR Alarm Limits

8 HR lower alarm limit Is the lower limit setting for the heart rate alarm, and accesses the HR Alarm Limits

9 HR source Indicates the source used to measure the heart rate

10 Filter mode Indicates the active ECG filter mode; see page 5-31.

11 Electrode fault

indication

Displays the electrode fault indicator(s) when a disconnected ECG lead or bad electrode

is detected, where LL = left leg, LA = left arm, and RA = right arm; and, LL, LA, RA, = RL

right leg or all leads

123456

13 11

5‐24MonitoringECGExpressionMR400InstructionsforUse

* The displayed waveform should at least be equal to the size of this indicator, as signals with lower amplitudes may be prone to

gradient interference; see Checking the ECG Signal Strength on page 5-16 for details.

Changing the Heart Rate Alarm Limits

TheHeartRateAlarmLimitsmenucanbeaccessedbytouchingthealarmlimitsettingsintheECG

VSbox.

12 ECG VS waveform Is the ECG waveform (Trace B, when enabled)

Note

To change the waveform speed, see Sweep Speed on page 3-25.

13 Scale indicator Represents a 1 millivolt signal amplitude for the selected scale of Trace B*

14 Lead type Is the selected ECG lead for Trace B

15 Lead type Is the selected ECG lead for Trace A

16 Scale indicator Represents a 1 millivolt signal amplitude for the selected scale of Trace A*

Item Name Definition

1Alarm limit settings, ECG VS box

2Extreme Tachycardia button

3High button

4Low button

5 Extreme Bradycardia button

6 HR Alarm Limits menu label

8 9 10 11 12 13 14 15 16

Tochangetheheartratealarmlimitsettings

Note

See chapter 4 for detailed alarm limit setting instructions and options.

7Enter button

8Current adjustment

9Extreme Bradycardia delta value

10 Extreme Bradycardia alarm setting

11 Alarm limit, minimum

12 Lower alarm limit setting

13 Upper alarm limit setting

14 Alarm limit, maximum

15 Extreme Tachycardia alarm setting

16 Extreme Tachycardia delta setting

Step Action

1 SelectthealarmlimitsettingsintheECGVSbox.

TheHRAlarmLimitsmenuappears.Currentsettingsaredisplayed.

2 SelecttheLow,High,∆ExtrBrady,or∆ExtrTachybutton.

Theselectedbuttonwillbehighlightedandthecurrentadjustment

willbedisplayed.

3Usingthekeypad,ortheincrement,decrement,orOffbuttons,

enterthedesiredsetting.

Thecurrentadjustmentwillreflectthesetting.

4PresstheEnterbuttontosavethesetting.

Thealarmlimitsettingisupdated.

5Tochangeotheralarmlimitsettings,repeatsteps2,3,and4.

Thecurrentadjustmentwillreflectthechange.

5‐26MonitoringECGExpressionMR400InstructionsforUse

ECG Menu

ECGmenuitemsallowyoutocontrolECGtraces,functionsandsettings.

ToopentheECGmenu

SelecttheECGVSbox.

ThefollowingECGmenuitemsareavailable:.

1 Trace A Lead

2Trace B Lead

3Scale

4Gating Source

5HR Source

6 HR Tone Source

7 Filter Mode

8Extreme HR

9Pediatric ECG

10 T-Wave Suppression

ECG menu

ECG VS box

TochangesettingsintheECGmenu

Trace A Lead

SetstheECG A leadconfiguration(leadview).ForbestECGandheartratemonitoring,always

selecttheoptimalleadview,theonethatprovidestheleastartifactandlargestwaveform

detection.

Thefollowingoptionsareavailable:

•Off

•I

•II(Default)

•III

•AVL

•AVR

•AVF

TosettheECGAlead

Step Action

1 SelecttheECGVSbox.

TheECGmenuappears.Currentsettingsaredisplayed.

2 SelectfromthefollowingECGmenuitems:

TraceALead

TraceBLead

Scale

GatingSource

HRSource

HRToneSource

FilterMode

ExtremeHR

PediatricECG

T‐WaveSuppression

Themenuitemappears.Thecurrentsettingishighlighted.

3 Selectthedesiredsettingfromthemenuoptions(exceptExtreme

HR,PediatricECGandT‐WaveSuppression,whichareselectable

ontheECGmenu).

Thesettingisentered.

4Tochangeothersettings,repeatsteps2and3.

5‐28MonitoringECGExpressionMR400InstructionsforUse

SeeChangingtheLeadViewonpage5‐17.

Trace B Lead

SetstheECG B leadconfiguration(leadview),allowingyoutoviewtwoECGwaveforms

simultaneously.

Thefollowingoptionsareavailable:

•Off(Default)

•I

•II

•III

•AVL

•AVR

•AVF

TosettheECGBlead

SeeChangingtheLeadViewonpage5‐17.

Scale

SetsthescalefortheECG waveforms.Aftermakingthissetting,takenoteofthescaleindicator

(seepage5‐22).Iftheselectedscaleresultsinawaveformwithdistortedorclippedpeaks,

Overscalewillbedisplayedandanothersettingshouldbeselecteduntilthemessagestops.

Thefollowingoptionsareavailable:

•AutomakesthewaveformfilltheECGtracearea(notrecommendedforuseintheMR).

•1x

•5x

•10x(Default)

•15x

•20x

•25x

•30x

•40x

TosettheECGscale

SeeSelectingtheScaleonpage5‐16.

Note

Scale does not affect the signal analyzed by the MR400 for QRS detection and ECG gating.

Gating Source

SetsthecardiacgatingsourcebasedonameasuredsignalthatisusedforMRsystemtriggering.

(ThisisthesameoptionasintheSPO2menu.)

Thefollowingoptionsareavailable:

•ECGoutputsasignalthatrepresentsthedetectionoftheR‐peakofaQRScomplex.

(Default)

•Pulseoutputsasignalthatrepresentsthedetectionofthepeakoftheperipheralpulse

complex.

Tosetthegatingsource

SeeAppendixDfordetails.

Note

Trace A is the default output channel for interfacing the cardiac gating input. To use Trace B, set

Trace A to off, and ensure that Trace B is active (that is, not off); see page 5-28.

HR Source

Selectsthesourcethatproducestheheartrate,asdisplayedintheECGandSPO2VSboxes

(identicaltoandinteractivewithsameoptionintheSPO2,P1andP2menus).

Thefollowingoptionsareavailable:

•Autosetsthesourceautomaticallyaccordingtothehighestpriorityactiveinputthatisfirst

toreportvalidpatientdata.Thepriorityranking(highesttolowest)isECG,P1,P2,SPO2

(providedthattheP1andP2channelshavebeenlabeledABP;seeSetLabelonpage8‐24

fordetails).Thesourcewillbecomeunavailablewhenithasproducednovaliddatafora

periodoften(10)ormoreseconds.Thesystemexaminesthehighestpriorityactiveinput.

Ifnotfound,thesecond‐highestpriorityinputischosen,etcetera.Ifnonearepresent,

thenNoneisdisplayedastheheartratemeasurementnumeric.

•ECGsetsECGasthesource.(Default)

•ABPsetsABPasthesource(ifnopressurechannelislabeledABP,awarningboxwillallow

automaticrenamingandselectionbeforeproceeding;alsoseeSetLabelonpage8‐24).

5‐30MonitoringECGExpressionMR400InstructionsforUse

•SPO2setsSPO2asthesource.

Tosettheheartratesource

HR Tone Source

Setsthesourceusedfortheheartratetone(identicaltoandinteractivewiththesameoptionin

theMonitorSetup>SoundAdjustmenuandintheSPO2menu).

Thefollowingoptionsareavailable:

•Offremovestheheartbeatdetectedsymbolfromthedisplayandsoundsnopulsetone.

(Default)

•QRSprovidestheheartbeatdetectedsymbolandatonetriggeredbytheQRSdetection

fromtheECGvitalsign.

•SPO2providestheheartbeatdetectedsymbolandatonemodulatedbytheSPO2vital

sign,wherethelowertheSPO2value,thelowerthepitch.

Tocontroltheheartratetonesource

Step Action

1 SelecttheECGVSbox.

TheECGmenuappears.Currentsettingsaredisplayed.

2 SelectHRSource.

TheHRSourcemenuappears.Thecurrentsettingishighlighted.

3 Selectthedesiredsettingfortheheartratesource:

Auto

ECG

ABP

SPO2

Thesourceischanged.

Step Action

1 SelecttheECGVSbox.

TheECGmenuappears.Currentsettingsaredisplayed.

Filter Mode

SetsthefilteringmodefortheECGsignal.AllfilteringmodeexceptMonitorutilizeanadaptive

filterschemeforremovalofgradientartifactsgeneratedbyMRsystems.

Notes

• Due to the variety of MRI sequence characteristics, if the filter recommendations below do

not provide optimum performance in all cases, the selection may improve ECG performance

during a specific scan sequence.

• ECG performance can be affected by electrode placement, the MRI procedure, the image

slice angle and slice thickness. In situations where ECG performance is not optimal, select

the ECG lead view (I, II, III, AVL, AVR, or AVF) that provides the best performance; see

page 5-17.

• For cases not requiring cardiac gating, start with the Default filter (depending on the MRI

sequence) then switch filters if a gradient artifact is noticed. If a gradient artifact is still

present, check ECG signal strength and try lead I or III.

Thefollowingoptionsareavailable:

•Monitorisamodethatprovidesfilteringcharacteristicsthatmeetthespecificationofthe

AAMIandIEC.Thismodeisusefulduringpatientpreparation,transporting,base‐lining,et

cetera,butisnotmeantforuseduringactiveMRIsequencesduetonoise;seepage5‐18.

•Defaultprovidesthebestpossibleperformanceon0.15to3.0TMRsystemsduringEcho

TraintypeMRIsequences.(Default)

•Advanced1providesthebestpossibleperformanceduringcardiovascular(CV)MRIscans

thatinvolvesteady‐statefreeprecessionimagingwithbalancedgradient(True‐FISP,

FIESTA,orBalancedFFE)sequenceson1.5and3.0TMRsystems.Forcasesrequiring

cardiacgating,startwiththeCardiacfilterinLeadIIandswitchfiltersifagradientartifact

isnoticed.Ifgradientartifactisstillpresent,checksignalamplitudeandtryLeadIorIII.

2 SelectHRToneSource.

TheHRToneSourcemenuappears.Thecurrentsettingis

highlighted.

3 Selectthedesiredsettingforthetonesource:

Off

QRS

SPO2

Thesettingischanged.

Step Action

5‐32MonitoringECGExpressionMR400InstructionsforUse

•Advanced2providesthebestpossibleperformanceon1.5and3.0TMRsystemsfor

removalofgradientartifactsgeneratedbyMRsystemsduringMRIsequencessuchas

neurologicalandcardiovascularscans.

Tosetthefiltermode

SeeSelectingtheFilterModeonpage5‐22.

Extreme HR

ControlsthealarmfunctionforExtremeBradycardia(whereadecreaseinheartratebya

selectablevaluelowerthanthelowHRlimitsettingwillresultinanalarm),andforExtreme

Tachycardia(whereanincreaseinheartratebyaselectablevaluehigherthanthehighHRlimit

settingwillresultinanassociatedalarm).

Thefollowingoptionsareavailable:

•OffdoesnotreportanextremeHRalarmevent.

•OnreportsanextremeHRalarmeventwhendetectedanddisplaysthe∆ExtrBradybutton

(forExtremeBradycardia)andthe∆ExtrTachybutton(forExtremeTachycardia)onthe

ECGAlarmLimitsmenuandthecontrolsfortheextremeHRalarmadjustments.(Default)

TocontroltheExtremeHRalarmfunction

Pediatric ECG

ProvidesadditionalECGfilteringwhenpatients,particularlypediatrics,presentwithnarrowQRS

complexesand/orhigh(120BPM)heartrates.

Thefollowingoptionsareavailable:

•OffdoesnotapplythepediatricECGfilter.(Default)

•OnprocessesECGdatausingapediatricalgorithm,inadditiontothegradientfiltersetting

(andwheniftheECGtraceisprinted,PEDECG=ONorPEDECG=OFFwillappearonthe

strip).

Step Action

1 SelecttheECGVSbox.

TheECGmenuappears.Currentsettingsaredisplayed.

2LocateExtremeHRandselectthedesiredsetting:

Off

Thesettingisentered.

Note

If Patient Type is set to Neo then Pediatric ECG is set to On and locked. When Patient Type is

changed to Adult, Pediatric ECG will be set to off and unlocked.

TocontrolpediatricECGfiltering

T-Wave Suppression

AllowsyoutoreducetheT‐waveamplitudewhenextremelylargeduetothe

magnetohydrodynamiceffect(MHD),whichcanpreventgating.Useforaccurategatingwhenan

unusuallyhighT‐waveamplitude,relativetotheR‐waveamplitude,isproduced.

Thefollowingoptionsareavailable:

•Off(Default)

•On

Note

T-Wave Suppression is unavailable when Filter Mode is set to Monitor; see page 5-31.

Pediatric ECG Patient Type Condition

Off Adult Unlocked

On Pediatric Unlocked

On Neonatal Locked

Step Action

1PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

2LocatePediatricECGandselectthedesiredsetting:

Off

Thesettingisentered.

5‐34MonitoringECGExpressionMR400InstructionsforUse

TocontrolT‐wavesuppression

Step Action

1 SelecttheECGVSbox.

TheECGmenuappears.Currentsettingsaredisplayed.

2LocateT‐WaveSuppressionandselectthedesiredsetting:

Off

Thesettingisentered.

CHAPTER 6

Monitoring SPO2

ThepulseoximetryfeatureoftheMR400usesamotion‐tolerantsignalprocessingalgorithm

basedonFourierArtifactSuppressionTechnology(FAST)andiscalibratedtodisplayoxygenated

hemoglobinmeasurements,avisualpulseindicationandapulserate,specifically:

•Oxygensaturationofarterialblood(SPO2):Thepercentageofoxygenatedhemoglobinin

relationtothesumofoxyhemoglobinanddeoxyhemoglobin(functionalarterialoxygen

saturation).

• Plethysmography(pleth)waveform:Avisualindicationofthepatient’spulsatileblood

flow.

•Pulserate(asderivedfromtheplethwaveform):Thenumberofdetectedpulsationsper

minute.

•Perfusionindexvalue–Anumericalindicationofthepulsatileportionofthemeasured

signalcausedbyarterialpulsation.

CAUTION

Before use, verify that the wSpO2 module is operating correctly and communicating by checking

the displayed SPO2 numeric and waveform. Also, ensure that the wSpO2 module has a

sufficiently charged battery by checking its displayed status symbol; see page 2-16.

Note

A pulse oximeter should be considered an early warning device. As a trend toward patient

deoxygenation is indicated, blood samples must be analyzed by a laboratory co-oximeter to

understand the patient’s condition completely.

wSpO2 Module, SpO2 Probe and SpO2 Attachment

ThewSpO2module,SpO2probeandSpO2attachment(cliporgrip)areintendedforpatientuses

whennon‐invasivearterialoxygensaturation,pulseratemonitoringorpulsegatingarerequired.

ThewSpO2module,SpO2probeandSpO2attachmentmaynotbeusedwithintheMRsystem

bore.

6‐2MonitoringSPO2ExpressionMR400InstructionsforUse

WARNING

Philips has verified the compatibility of the monitor, probe, and cable specified in the

Accessory List. The user should verify that only Philips accessories specified in the Accessory

List are used. Otherwise, patient injury can result.

CAUTION

If dropped, the wSpO2 module must be verified for correct operation before use; see page 14-12.

Note

Refer to your facility's biohazard procedure for disposal of SPO2 attachments and probes when

they become unusable. Usually probes are disposed of as medical waste per facility procedures.

Patient Preparation for SpO2 Monitoring

WhenmonitoringSpO2,theSpO2attachment,thesiteselectedonthepatient,theSpO2

attachment’spositiononthepatient,andtheambientenvironmentwillimpacttheperformance

andoperationoftheparameter.

Selecting the Site and SpO2 Attachment

Whenapplyingtheclipsorgripstothepatient,sitepreparationandthepressureandalignment

oftheSpO2attachmentareimportantfactorstoconsider.Selectthemostappropriatelimbthat

bestfitstheattachment’ssize.Formeasurementstobeaccurateandreliable,theoptimumfitis

reachedwhenthefiberheadwindowsontheattachmentopposeeachotherwhilecoveringskin

ornail.RefertotheinstructionsprovidedwiththeSpO2attachmentwhenselectingand

connectingthecliporgrip.

Attaching the Clip or Grip to the SpO2 Probe

Toattachaclip(orgrip)totheSpO2probe

CarefullysnapthefiberheadsontheSpO2probeintothe

receptacles(windows)ontheSpO2attachment(cliporgrip).

Eitherfiberheadcanbeinsertedintoeitherwindowonaclipor

grip.

Applying the SpO2 Attachment to the Patient

ReadthewarningsbeforeapplyinganSPO2attachmenttothepatient.

WARNINGS

•General fit: If a clip or grip is too loose, it might compromise the optimal alignment or

dislocate. If the clip or grip is too tight (for example, if the application site is too large

or becomes large due to edema), excessive pressure may be applied resulting in venous

congestion distal from the application site, which could lead to interstitial edema,

hypoxemia, tissue malnutrition, and inaccurate measurements. Skin irritations may

occur as a result of the clip or grip being attached to one location for too long.

Periodically inspect the clip or grip application site and change the application site at

least every 4 hours. Exercise care when using tape to secure the clip or grip, as the

stretch memory properties of most tapes can apply unintended pressure to the site

easily.

• Extremities to avoid: Avoid placing the clip or grip on extremities with an arterial

catheter, intravascular venous infusion line, or inflated blood pressure cuff. Failure to

do so may result in inaccurate readings or false alarm indications.

• Protect the probe from contact with any liquid. If the probe, clips or grips show signs

of damage like exposed fibers, replace the part immediately. Do not use damaged

equipment.

• Keep detached grips and clips away from small children to avoid possibility of

swallowing.

1 SpO2 probe

2 SpO2 attachment (clip shown)

3Fiber heads

6‐4MonitoringSPO2ExpressionMR400InstructionsforUse

ToapplyareusableSpO2cliptothepatient

ToapplyadisposableSpO2grip(all,exceptneonate)tothepatient

Step Action

1 Selecttheapplicationsite.ItshouldmatchtheSpO2clipsizeso

thattheattachmentdoesnotfallofforapplyexcessivepressureat

thesite.

2Ifpresent,removeanycolorednailpolishfromtheapplicationsite.

3Pressthecliptoopen.

4Pushtheclipoverafingersoeither

fiberheadisonthetopovertheroot

ofthenailandtheotherfiberhead

oppositetoit.

5Ensurethatthefingeristouchingthestopatthecushionandlays

nicelycenteredintheclip.

Step Action

1 Selecttheapplicationsite.ItshouldmatchtheSpO2gripsizeso

thattheattachmentdoesnotfallofforapplyexcessivepressureat

thesite.

2Ifpresent,removeanycolorednailpolishfromtheapplicationsite.

3Liftoffthereleaselinersthatprotecttheadhesive.

4Putthefinger(ortoe)ontoeithersideoftheattachment‐theyare

symmetrical‐suchthatthetipcoversthewindowcompletelyand

doesnotprotrudeoverthehinge.

5Closethegrip.Ifthefitisgood,presstheattachmentfirmlyonthe

fingerortoe.Ifthefitisnotgood,repositiontheattachment.Make

surethelimbiscenterednicelyintheattachment.

6Wrapthefoamwingsaroundthefin‐

gerandattachmentandsticktothe

opposinggripside.Donotstretchthe

foamtoapplyexcessivepressure.

ToapplyadisposableneonateSpO2griptothepatient

WARNING

Disposable SpO2 attachments are designed for single patient use and must be disposed after

use. They must not be cleaned and reused. Follow your hospital’s guidelines for appropriate

disposal. Reuse of single-use devices can result in spread of patient infection, degradation of

monitoring performance, or inaccurate measurements.

Step Action

1 Selecttheapplicationsite.ItshouldmatchtheSpO2gripsizeso

thattheattachmentdoesnotfallofforapplyexcessivepressureat

thesite.

2Liftoffthereleaselinersthatprotecttheadhesive.

3 Proceedaccordingtotheapplicationsite:

• Footapplication:Alignthehingeontheoutsidefacingridge

ofthefoot.Makesuretheattachmentisasfaraspossibleto‐

wardthesmalltoebutnotoverit.

•Hand/Wristapplication:Alignthehingeontheoutsidefac‐

ingridgeofthehandorwrist.Youmayhavetoswivelthefi‐

berheadstoanoptimalpositiontoeasetheapplication.

4Withthehingealignedwiththeridgeofthefoot/hand/wrist,press

onesidetotheskinandthenwraptheothersidearoundthelimb

pullingthelongfoampiecegently.

5Pressbothfiberheadsgentlytoattach

theadhesives.

6Securethelongerfoampiecebypressingitfirmlytothefoam/

adhesiveoftheopposingside.

7Ensurethatthetwofiberheadsareopposingandhavegoodskin

contact.Theanglebetweenthetwofiberheadsshouldbeassmall

aspossible,notexceeding45°.Iftheattachmentopenstoomuch,

reattachortryanothersite.

6‐6MonitoringSPO2ExpressionMR400InstructionsforUse

Perfusion Index Value

Whenenabled,thedisplayedperfusionindexvalue(seepage6‐8)isanindicationofthepulsatile

portionoftheSpO2signalcausedbythepatient'sarterialbloodflow.Ifyouneedanindicationof

changeinpulsevolume,useperfusionindexvalue.Thisvaluecanalsobeusedasaquality

indicatoroftheSpO2measurementfromthemodule.Thetablebelowprovidesgeneralguidelines

regardingthisindexvalue.

Note

If a Low Perf alarm is generated, see page 4-32 for corrective actions.

Positioning the wSpO2 Module for Scanning

WARNING

The wSpO2 module must be kept outside the MR system bore or image distortion may

result.

Toensurethebestperformance,specificpositioning

considerationsarerequiredwhenusingthewSpO2modulein

theMRmagnetroom,includingduringharshscansequences

withperipheralnervestimulationlevelsabove80percent.

Whileconsideringthescantobeperformed:

•PlacethewSpO2moduleonornearthepatientandas

closeaspossibletotheboreopening;

• KeeptheSpO2probeandwSpO2moduleoutsidetheMR

systembore;

•PlacethewSpO2moduleonacushionedsurfaceto

minimizeMRvibrations;and,

•CovertheSpO2attachmentsiteonthepatientwith

opaquematerial.

PerfusionIndexValue Meaning

Above1.0 Optimal–highqualityreadings

0.3to1.0 Acceptable–goodqualityreadings

Below0.3 Marginal–Attachmentpositionshouldbeadjusted

oranothersiteshouldbeused.

WARNING

If the wSpO2 module is incorrectly positioned when used within the MR magnet room, the

following factors can cause SPO2 waveform distortion and numeric inaccuracies, and

respiration numeric inaccuracies:

• Fast magnetic field changes usually found but not limited to scan sequences using PNS

levels above 80 percent.

• Severe vibrations induced by scan sequences using PNS levels above 80 percent.

• Distance from the bore opening.

• Distance from the bore iso-center in the x, y, or z direction.

ToensurebestperformanceduringSPO2measurements

Step Action

1Ensurethatthefiberheadsaredirectlyoppositeeachother,asthe

lightmustpassthroughthepatient’stissueandbereceivedfor

properoperation.

2Swiveleachfiberheadintoapositionthatcausestheleastbending

ofthecablewhileprovidingthemostcomforttothepatient.

3CheckthebatteryindicatoronthewSpO2moduletoensurethat

enoughchargeexists:

• Greenbatteryindicator=Chargesufficient;proceedtostep5.

•Redbatteryindicator=Chargelow;proceedtostep4.

Seepage2‐11fordetails.(Also,youcanreferencethestatus

informationpane;seepage2‐16.)

4InsertachargedmodulebatteryintothewSpO2moduleandthen

recheckthebatteryindicatortoensureasufficientchargebefore

proceeding;seepage1‐26.

5CheckthenetworkchannelindicatoronthewSpO2moduleto

ensurecommunicationisestablishedwiththeMR400:

• Steady=Goodcommunication;proceedtostep7.

• Flashing=Nocommunication;proceedtostep6.

Seepage2‐11fordetails.(Also,youcanreferencethestatus

informationpane;seepage2‐16.)

6EnsurethatthewSpO2moduleiswithin9.1m(30feet)ofthe

MR400,inthesameMRIroomorinthesameshieldedroom,andis

settothesamewirelessnetworkchannelusedbytheMR400;see

page1‐29.

7ChecktheperfusionindexvalueforthequalityoftheSpO2

measurementfromthemodule;seepage6‐6fordetails.

6‐8MonitoringSPO2ExpressionMR400InstructionsforUse

SPO2 Waveform and VS Box

TheSpO2measurementsaredisplayedasawaveformintheVStraceareaofthescreenandas

numericinformationintheSPO2VSbox.Otherdata,includingSpO2‐relatedalarminformation,

arealsoprovidedinthisareaofthescreen,asdetailedbelow.

8 SelectthePatientType.

SeeSelectingthePatientTypeonpage3‐11.

9CheckforanydisplayedSPO2messages

Ifamessageispresent,followtherecommendedactiontoachieve

betterresults(seepage4‐26).

10 Placethemoduleascloseaspossibletotheboreopening.(Ifthe

modulecanbeplacedoutsidethebore,positioningattheiso‐

centerisnotnecessary.)

11 KeeptheSpO2probeandmoduleoutsidetheMRsystembore.

12 Placethemoduleonacushionedsurface.

13 CoverthepatientSpO2attachmentsitewithopaquematerial.

14 Duringmeasurement,checkthepatienttoensurethatthe

applicationsitehasapulsatileflowandthatthesitehasnot

changedinthickness(forexample,duetoedema)causingan

improperfit.

Step Action

234

Assessing Suspicious SPO2 Readings

Pulseoximetrymeasurementsarestatisticallydistributed.Withneweralgorithms,suchasFAST‐

SPO2,thecalculationofSPO2isnotdirectlylinkedtothecorrectdetectionofeachpulse.When

thepulserateisveryloworastrongarrhythmiaispresent,theSPO2/plethysmographypulse

ratemaydifferfromtheheartratecalculatedfromECG.Thisdoesnotindicateaninaccurate

SPO2value.IfyoudoubtthemeasuredSPO2,usetheplethysmographywavetoassessthesignal

quality.

WARNING

Always shield (for example, cover with opaque material) the SPO2 clip or grip from

extraneous incidental light sources, as such light can cause erroneous SPO2 readings or

pulse detection errors.

Item Name Definition

1 SpO2 VS waveform Is the detected SpO2 (pleth) pulsatile waveform (Trace C), automatically adjusted for

proper viewing if above a minimum level

Note

To change the waveform speed, see Sweep Speed on page 3-25.

2 Alarm flag area Displays SPO2 alarm flags when detected; see page 4-31.

3SPO2 VS box label Indicates the SpO2 vital sign parameter, and accesses the SPO2 menu

4 Heart rate numeric Is the patient’s detected heart rate measurement

5 Unit of measure Indicates that the heart rate numeric is given in BPM (beats per minute)

6 SpO2 upper alarm limit Is the upper limit setting for the SpO2 alarm, and accesses the SPO2 Alarm Limits

7 SpO2 lower alarm limit Is the lower limit setting for the SpO2 alarm, and accesses the SPO2 Alarm Limits

8 SpO2 numeric Is the patient’s detected arterial oxygen saturation measurement, given as a percentage

9 Perfusion index Is the value for the portion of the measured signal caused by the pulsating arterial

blood flow, which can be used as a measurement quality indicator; see page 6-15

6‐10MonitoringSPO2ExpressionMR400InstructionsforUse

WARNINGS

• SPO2 monitoring requires the detection of valid pulses to correctly determine SPO2

and heart rate values. Any of the following items can lead to inaccuracies of the SPO2

readings and/or prolonged measurement time: Ambient light (including photodynamic

therapy), physical movement (patient and imposed motion), arrhythmias and/or

erratic heartbeats, diagnostic testing, electromagnetic interference, electrosurgical

units, dysfunctional hemoglobin, intravascular dyes, presence of dyes or pigments at

the application site, and inappropriate positioning of the pulse oximeter attachment. If

questionable readings are obtained, check the patient’s vital signs by alternate means

before administering medication.

•Attachment movement, ambient light (especially strobe or flashing lights) or

electromagnetic interference can give unexpected intermittent readings when the

probe is not attached to a patient. Bandage and grip attachment designs are

particularly sensitive to minimal movement that might occur when the probe is

dangling, not attached to the patient. An unapplied probe may cause readings to be

displayed on the monitor. To avoid misdiagnosis, ensure the probe is applied to patient

correctly.

Changing the SPO2 Waveform Amplitude

TheverticalscaleofthedisplayedSPO2waveformcanbechangedtobestsuittheviewing

requirements.

TochangetheSPO2waveformamplitude

Step Action

1 SelecttheSPO2VSbox.

TheSPO2menuappears.Currentsettingsaredisplayed.

2 SelectSize.

TheSizemenuappears.Thecurrentsettingishighlighted.

3 Selectthedesiredsize:

10%

20%

40%

60%

80%

100%

Thesettingischanged.

Changing the SPO2 Alarm Limits

TheSPO2AlarmLimitsmenucanbeaccessedbytouchingthealarmlimitsettingsintheSPO2VS

box.

TochangetheSPO2alarmlimitsettings

1Alarm limit settings, SPO2 VS box

2High button

3Low button

4Desat button

5SPO2 Alarm Limits menu label

6Enter button

7Current adjustment

8Desat alarm setting

9Alarm limit, minimum

10 Lower alarm limit setting

11 Upper alarm limit setting

12 Alarm limit, maximum

Step Action

1 SelectthealarmlimitsettingsintheSPO2VSbox.

TheSPO2AlarmLimitsmenuappears.Currentsettingsare

displayed.

2 SelecttheLow,High,orDesatbutton.

Theselectedbuttonwillbehighlightedandthecurrentadjustment

willbedisplayed.(Desatmustbeon;seepage6‐15.)

3456

1098 1211

6‐12MonitoringSPO2ExpressionMR400InstructionsforUse

Note

See chapter 4 for detailed alarm limit setting instructions and options.

SPO2 Menu

SPO2menuitemsallowyoutocontrolSPO2functionsandsettings.

ToopentheSPO2menu

SelecttheSPO2VSbox.

3Usingthekeypad,ortheincrement,decrement,orOffbuttons,

enterthedesiredsetting.

Thecurrentadjustmentwillreflectthesetting.

4PresstheEnterbuttontosavethesetting.

Thealarmlimitsettingisupdated.

5Tochangeotherlimitsettings,repeatsteps2,3,and4.

Thecurrentadjustmentwillreflectthechange.

Step Action

SPO2 VS box

SPO2 menu

ThefollowingSPO2menuitemsareavailable:

TochangesettingsintheSPO2menu

Size

ChangestheverticalscaleoftheSPO2(pleth)waveformsothathighamplitudescanbescaled

downtoavoidclippingofthepeaksandlowamplitudescanbescaleduptoviewthepeaks.

Thefollowingoptionsareavailable:

1Size

2Averaging Time

3 Perfusion Index

4Gating Source

5Desat

6Desat Time

7HR Source

8 HR Tone Source

Step Action

1 SelecttheSPO2VSbox.

TheSPO2menuappears.Currentsettingsaredisplayed.

2TouchthemenuitemtoselectoneofthefollowingSPO2options:

Size

AveragingTime

PerfusionIndex

GatingSource

Desat

DesatTime

HRSource

HRToneSource

Themenuitemappears.Thecurrentsettingishighlighted.

3 Selectthedesiredsettingfromthemenuoptions(exceptPerfusion

IndexandDesat,whichareselectableontheSPO2menu).

Thesettingisentered.

4Tochangeothersettings,repeatsteps2and3.

6‐14MonitoringSPO2ExpressionMR400InstructionsforUse

•10%

•20%

•40%

•60%

•80%

•100%(Default)

ToadjustthesizeoftheSPO2waveform

SeeChangingtheSPO2WaveformAmplitudeonpage6‐10.

Averaging Time

Selectshowquicklythereadingrespondstochangesinthepatient’ssaturation,whereselecting

alongerdurationwillpreventthesaturationvaluefromchangingquicklywhichcanbeusefulfor

avoidingalarmtriggeringinpatientswithverydynamicconditionssuchasneonataland

pediatrics.

Thefollowingoptions(inseconds)areavailable:

•5Sec

•10Sec(Default)

•15Sec

TosettheaveragingtimeoftheSPO2reading

Step Action

1 SelecttheSPO2VSbox.

TheSPO2menuappears.Currentsettingsaredisplayed.

2 SelectAveragingTime.

TheAveragingTimemenuappears.Thecurrentsettingis

highlighted.

3 Selectthedesiredtimeforaveraging:

5Sec

10Sec

15Sec

Thesettingischanged.

Perfusion Index

Controlstheperfusionindexvalueindicationandalarmfunction(seepage5‐6).Thefollowing

optionsareavailable:

•Offdisablestheperfusionindexfunctions.

•Onenablestheperfusionindexfunctions.(Default)

Tocontroltheperfusionindexfunctions

Gating Source

SetsthecardiacgatingsourcebasedonameasuredsignalthatisusedforMRsystemtriggering.

(ThisisthesameoptionasintheECGmenu.)

Thefollowingoptionsareavailable:

•ECGoutputsasignalthatrepresentsthedetectionoftheR‐peakofaQRScomplex.

(Default)

•Pulseoutputsasignalthatrepresentsthedetectionofthepeakoftheperipheralpulse

complex.

Tosetthegatingsource

SeeAppendixDfordetails.

Desat

ControlsthedesaturationalarmandallowsadjustmentoftheDesatalarmsetting(seepage6‐

11),whereaDesatalarmwillbedeclaredwhenthedetectedoxygenationconditionhas

remainedatorbelowthevaluefortheperiodestablishedbytheDesatTimesetting(seepage6‐

16).

Thefollowingoptionsareavailable:

•Offdisablesthedesatalarmfunction.

Step Action

1 SelecttheSPO2VSbox.

TheSPO2menuappears.Currentsettingsaredisplayed.

2LocatePerfusionIndexandselectthedesiredsetting:

Off

Thesettingisentered.

6‐16MonitoringSPO2ExpressionMR400InstructionsforUse

•Onenablesthedesatalarmfunction.(Default)

Tocontrolthedesatalarmfunction

Desat Time

WhenDesatison,thissetsthetimethatmustpassbeforedeclaringthatadesaturation

conditionexists.

Thefollowingoptions(inseconds)areavailable:

•20Sec(Default)

•25Sec

•30Sec

•35Sec

•40Sec

Tosetthedesattime

Step Action

1 SelecttheSPO2VSbox.

TheSPO2menuappears.Currentsettingsaredisplayed.

2Locate

Desatandselectthedesiredsetting:

Off

Thesettingisentered.

Step Action

1EnsurethatDesatisOn.SelecttheSPO2VSbox.

TheSPO2menuappears.Currentsettingsaredisplayed.(Seepage

6‐15fordetails.)

HR Source

Selectsthesourcethatproducestheheartrate,asdisplayedintheECGandSPO2VSboxes

(identicaltoandinteractivewithsameoptionintheECG,P1andP2menus).

Thefollowingoptionsareavailable:

•Autosetsthesourceautomaticallyaccordingtothehighestpriorityactiveinputthatisfirst

toreportvalidpatientdata.Thepriorityranking(highesttolowest)isECG,P1,P2,SPO2

(providedthattheP1andP2channelshavebeenlabeledABP;seeSetLabelonpage8‐24

fordetails).Thesourcewillbecomeunavailablewhenithasproducednovaliddatafora

periodoften(10)ormoreseconds.Thesystemexaminesthehighestpriorityactiveinput.

Ifnotfound,thesecond‐highestpriorityinputischosen,etcetera.Ifnonearepresent,

thenNoneisdisplayedastheheartratemeasurementnumeric.

•ECGsetsECGasthesource.(Default)

•ABPsetsABPasthesource(ifnopressurechannelislabeledABP,awarningboxwillallow

automaticrenamingandselectionbeforeproceeding;alsoseeSetLabelonpage8‐24).

•SPO2setsSPO2asthesource.

Tosettheheartratesource

2 SelectDesatTime.

TheDesatTimemenuappears.Thecurrentsettingishighlighted.

3 Selectthedesiredtime(inseconds)forthealarmindication:

20Sec

25Sec

30Sec

35Sec

40Sec

Thesettingischanged.

Step Action

1 SelecttheSPO2VSbox.

TheSPO2menuappears.Currentsettingsaredisplayed.

2 SelectHRSource.

TheHRSourcemenuappears.Thecurrentsettingishighlighted.

Step Action

6‐18MonitoringSPO2ExpressionMR400InstructionsforUse

HR Tone Source

Setsthesourceusedfortheheartratetone(identicaltoandinteractivewithsameoptioninthe

intheMonitorSetup>SoundAdjustmenuandintheECGmenu).

Thefollowingoptionsareavailable:

•Offremovestheheartbeatdetectedsymbolfromthedisplayandnopulsetonewillbe

sounded.(Default)

•QRSprovidestheheartbeatdetectedsymbolandatonetriggeredbytheQRSdetection

fromtheECGvitalsign.

•SPO2providestheheartbeatdetectedsymbolandatonemodulatedbytheSPO2vital

sign,wherethelowertheSPO2value,thelowerthepitch.

Tocontroltheheartratetonesource

3 Selectthedesiredsettingfortheheartratesource:

Auto

ECG

ABP

SPO2

Thesourceischanged.

Step Action

1 SelecttheSPO2VSbox.

TheSPO2menuappears.Currentsettingsaredisplayed.

2 SelectHRToneSource.

TheHRToneSourcemenuappears.Thecurrentsettingis

highlighted.

3 Selectthedesiredsettingforthetonesource:

Off

QRS

SPO2

Thesettingischanged.

Step Action

ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)7‐1

CHAPTER 7

Monitoring CO2 (LoFlo Option)

WhenequippedwiththeLoFloCO2option,thepatient’sairwayrespiratorygascanbe

monitored.Thesystemusessidestreammeasurementstoproduce:

•AfractionalinspiredCO2(FiCO2)value(thelowestreadingoftheCO2waveforminthe

previous20seconds)andanend‐tidalCO2(EtCO2)valuemeasuredduringexpiration.

•Arespirationrate:Thenumberofbreathsperminute.

•Awaveformoftheconcentrationofcarbondioxideintherespiratorygases.

WARNINGS

•Do not use on patients that cannot tolerate the withdrawal of 50ml/min ± 10 ml/min

from the airway or patients that cannot tolerate the added dead space to the airway.

• An alarm will sound when the MR400 is too close to the MR magnet and shutdown of

CO2 monitoring will occur. Always position the MR400 as indicated on page 3-2.

Note

LoFlo option-equipped models do not feature a water trap (see page 7-4). If your MR400 is

equipped with a water trap, refer to chapter 9 for CO2 monitoring instructions.

MR400 Preparation for CO2 Monitoring

WhenpreparingtheMR400forCO2monitoring,ensurethatthewastegasport(seepage1‐19)

hasbeenconnectedtoyourfacility’sgasscavengingsystemfordisposalofsampledand

calibrationgases.

Note

Never route the waste gas tubing in a location that will allow it to be an obstruction or stepped on.

7‐2MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse

Operation and Use

Whenmonitoringanestheticagentgases,thetypicaloperationsandpossibleconditionsthatcan

arisemayresultinpotentialmessagesrequiringyourattention.Seepage4‐26foramessage

listingandsuggestedactions.

Warm-Up Period

Inordertoachieveaccurateidentificationsandmeasurements,theLoFlosystemrequiresa

warm‐upperiodtothermallystabilize.Thiswarm‐upperiodbeginswhentheCO2parameteris

activated.Uponactivation,CO2WarmingUpwillbedisplayeduntiltheLoFlosystembecomes

fullyoperational(about2minutes).

Zero Reference Adjustment

WARNING

During Zero calibration the system pulls ambient air through the zero intake port on the

cart The calibration system assumes that the ambient air will contain normal trace amounts

of CO2. If the system is placed in an unventilated area that allows CO2 (from the waste gas

port on the rear panel, if not connected to a gas scavenging system) to accumulate, the result

could be inaccurate CO2 zeroing and resulting inaccurate patient readings. Always place the

cart in a well ventilated area.

TheLoFlosystemwilloccasionallyperformazeroreferenceadjustment(ZeroCal)toensurethe

accuracyofthedisplayedgasconcentrations.PerformingCO2Zerowillbedisplayedduringazero

referenceadjustment;allowtheprocesstocomplete.Themaximumtimerequiredforcalibrationis

approximately40seconds.ZeroCalisnotrequiredwhenswitchingsamplinglines.

Undercertainconditions,ZeroCalwillnotbeallowed:

•Iflessthan20secondshavepassedsincedetectionofthelastbreath;

•IftheCO2temperatureisunstable;or

•IfthesamplinglineisdisconnectedfromtheCO2port.

Toperformamanualzeroreferenceadjustment

Step Action

1IfCO2WarmingUpisdisplayed,waitasthesystemthermally

stabilizes.Whenthemessageiscleared,proceed.

ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)7‐3

Breath Rate Distortion

Theeffectofrisetimedistortiontothegascurvebecomesapparentwhenthebreathingrate

increasessothatthetimeforafullinspiratoryorexpiratoryeventgetsshorter.Inthose

situations,duetotheeffectoftherisetime,thegascurvedoesnotreachthetrueend‐tidal(or

firstinspiredvalue)andtheend‐tidalgasvaluemaythenbeunderestimated.Correspondingly,

thefirstinspiredvaluemaybeoverestimated.Belowisanexaggeratedillustrationoftheeffect.

Thebreathratelimitforaccuratelyresolvedend‐tidalgasvalues(atanI:Eratioof1:1)maybe

foundinAppendixA.TheeffectofotherI:Eratiosmaybecalculatedbydeterminingthelengthof

theshortestinspiratory/expiratoryeventthatcanberesolvedaccurately:

tresolved=60/(2xBRlimit(1:1)

BRlimit(I:E)=60/((I+E)xtresolved)

Thedifferenceintheseresultswhencomparedtotherisetime'sspecificationisthatrisetime's

onlytests10‐90%performance.Thisspecificationisfor(0+accuracy)to(100‐accuracy)%andis

thusmuchtougher.Theabilitytoproperlyresolveend‐tidalvaluescanbemeasuredbyusingthe

set‐updescribedinISO80601‐2‐55:2011figure201.101.Inshort,themethodconsistsof

samplinggasfromtwodifferentsourcesconnectedtoanelectricallycontrolledpneumaticvalve

topermitrapidswitchingbetweenthetwosources.Duringthetest,thevalveissettoswitchgas

sourceatanumberoffrequencies(simulatingtherangeofspecifiedbreathrates)andforeach

frequencytheend‐tidalvaluepresentedbythegasanalyzerisnoted.Fromadiagramofend‐tidal

valueoverfrequency,thefrequencyatwhichthegasanalyzerisnolongerabletoresolveend‐

tidalvaluesaccordingtospecificationisidentified.Thisabilitytoproperlyresolveend‐tidalvalues

islistedinthespecification.

2 SelecttheCO2VSbox.

TheCO2menuappears.Currentsettingsaredisplayed.

3 SelectZeroCal.

CalibrationwillbeginandPerformingCO2Zerowillbedisplayed.

Whencomplete,themessagewillberemoved.

Step Action

Fi error

Percent

Time

Et error

- - at gas sampling site

— as presented by gas analyzer

7‐4MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse

Patient Preparation for CO2 Monitoring

Whenpreparingapatient,theaccessorypositiononthepatientwillimpacttheperformanceand

operationoftheCO2parameter.

Selecting the CO2 Accessory

Inpatientsonabreathingcircuit,asampleoftherespiratorygasisdrawnfromthepatient’s

breathingcircuitthroughanairwayadapterandagassamplingline.Inpatientswhoarenotona

breathingcircuit,thegassampleisdrawnthroughanasalcannula.Thesespeciallydesigned

cannulasandon‐airwayadaptersincorporateafilterandsamplecelltoprovidemaximum

filtrationoffluidsandcontaminantstoprotectagainstsystemintake.WhenselectingCO2

accessories(seepage1‐34foralisting),considerthefollowing:

•Thetypeofpatient(adult,pediatric,orneonatal)

•Whetherthepatientisreceivingsupplementaloxygen

•Theconditionofthepatient

•Allaccessoriesaresingleuse.

Connecting the Sampling Line

Toconnectthesamplingline

Step Action

1InsertthesamplinglineconnectorintotheCO2portonthepatient

connectionpanelandthenpushtheconnectorforwarduntilyou

feelorhearitclickintoplace.

Sampling line connector

CO2 port

ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)7‐5

WARNINGS

•Inspect CO2 port and accessories before use. If the sampling line, connector or port

show signs of damage, replace the part immediately or discontinue use and contact

technical support. Never use damaged equipment.

• Frequently inspect the patient sampling line and keep it clear of any moving

mechanisms (for example, table wheels) which could cut, pinch, or dislodge the

sampling line. Leaks, reduced or stopped flow, or internal venting of sampled gas into

damaged tubing will cause inaccurate measurements.

• Do not position the sampling line in any manner that may cause entanglement or

strangulation.

• Replace the sampling line if excessive secretions are observed, as inaccurate

measurements could result if the flow is reduced or stopped.

• Leakages in the breathing system or sampling system may cause the displayed EtCO2

values to be too low. Always connect all components securely and check for leaks

according to standard clinical procedures. Displacement of the sampling line cannula

or airway adapter can cause lower than actual EtCO2 readings.

• If CO2 values for patients who are not on a breathing circuit appear extremely low,

check whether the patient is breathing through the mouth or whether one nostril is

blocked.

Notes

• For optimum fit and compatibility, use only specified parts.

• Always inspect the patient sampling line after attachment to the MR400.

2IfCO2WarmingUpisdisplayed,waitasthesystemthermally

stabilizes(about2minutes).Whenthemessageiscleared,

proceed.

3AlwaysremovethepatientsamplinglinefromtheCO2portwhen

notinuse.(Toremovethesamplingline,pressdownonthelocking

tabandpulltheconnectorfromtheport.)

Note

To increase the life of the filter and pump, when CO2 will not be

used to monitor a patient, we recommend turning the CO2

parameter off; see Parameters on page 3-18.

7‐6MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse

Applying the Sampling Line to the Patient

Selectthepatientsamplinglinethatisappropriateforthepatientsizeandapplication.Patient

samplinglineswiththeairwayadapterareintendedforusewithbreathingcircuitsand

anesthesiacircuitsthathaveanintegratedairwayadapter.

WARNING

Patient sampling lines are intended for single-patient use only. Do not clean or disinfect these

items. Follow your hospital’s guidelines for appropriate disposal. Reuse of single-use devices

can result in spread of patient infection, degradation of monitoring performance, or

inaccurate measurements.

CAUTIONS

• The accuracy of the data is greatly influenced by the proper use and fitting of the patient

sampling line to ensure proper sampling without the introduction of outside air.

• Remove the patient sampling line from the CO2 port when not in use.

Toapplythesamplinglinetothepatient

Step Action

1Ensurethatthesamplinglineisclean,dryandundamaged.Replace

thelineifnecessary.

2InsertthesamplinglineconnectorintotheCO2port(seepage7‐4).

Aclickwillbeheardwhenproperlyinserted.

3 Positionthecannulaonthepatient’sfaceby

insertingthenasalprongsintothenostrils.

4Passthetubingovertheearsandbehindthehead,

ensuringthepatient’sheadwillnotrestonanypart

ofthecannulawhilethepatientislyingdown.

5Slidethesleevetowardthepatient’sheadtoassurea

goodfitofthecannula.

6Ifusingthesamplinglinewiththeairwayadapter,proceedtostep

7;otherwisegotostep8.

ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)7‐7

CO2 Waveform and VS Box

TheCO2measurementisdisplayedasawaveformintheVStraceareaofthescreenandas

numericinformationintheCO2VSbox.Otherdata,includingCO2‐relatedalarminformation,are

7Placetheairwayadapterattheproximalendoftheairwaycircuit.

CAUTION

Always insert the patient sampling line into the CO2 port before

inserting the airway adapter into the breathing circuit. Failure to

follow this may introduce a leak in the circuit, thereby reducing set

minute volume.

Note

Do not place the airway adapter between the ET tube and the elbow

as this may allow patient secretions to accumulate in the adapter. If

pooling does occur, replace the airway adapter. To prevent moisture

from draining into the airway adapter, always place the adapter

tubing in a up position, as shown above.

8 SelectthePatientType.

SeeSelectingthePatientTypeonpage3‐11.

9Checkthattheconnectionshavebeenmadecorrectlybyverifying

thepatient’sbreathingeffortswiththedisplayedwaveform.

WARNING

Before completion of patient setup, ensure that the

patient’s breathing efforts coincide with the displayed

CO2 waveform.

10 Ifthefollowingwarningisdisplayed:

PersistentCO2occlusiondetected.

PleaseclearocclusionandpressOK

toresumeusingCO2

Clearanypinchesorobstructionsinthesamplinglinebefore

proceeding.

Step Action

7‐8MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse

alsoprovidedinthisareaofthescreen.(CO2[RESP]informationcanbedisplayedintheCO2VS

boxorintheRESPVSbox,asdetailedbelow.)

Item Name Definition

1 CO2 VS waveform Is the detected CO2 waveform (Trace D)

Note

To change the waveform speed, see Resp Speed on page 3-25.

2 Alarm flag area Displays CO2 alarm flags when detected; see page 4-31.

3CO2 VS box label Indicates the CO2 vital sign parameter, and accesses the CO2 menu

4 Unit of measure Indicates that the gas measurement numeric values are given in mmHg

(millimeters of mercury) or kPa (kilopascals); see page 7-11.

5 FiCO2 numeric Is the patient’s detected fractional inspired CO2 measurement

6 EtCO2 numeric Is the patient’s detected end-tidal CO2 measurement

7 EtCO2 upper alarm limit Is the upper limit setting for the end-tidal CO2 alarm, and accesses the CO2

(Et) Alarm Limits menu

8 EtCO2 lower alarm limit Is the lower limit setting for the end-tidal CO2 alarm, and accesses the CO2

(Et) Alarm Limits menu

9Respiration rate upper alarm

limit

Is the upper limit setting for CO2-derived respiration rate alarm, and accesses

the CO2 (RESP) Alarm Limits menu

10 Respiration rate lower alarm

limit

Is the lower limit setting for CO2-derived respiration rate alarm, and accesses

the CO2 (RESP) Alarm Limits menu

11 Respiration rate numeric Is the patient’s detected respiration rate measurement, as derived from CO2

12 Unit of measure Indicates that the respiration rate numeric is given in RPM (respirations per

minute)

When Source is set to BEL in the RESP menu (see page 10-5), the CO2 VS box will also contain CO2-derived respiration rate

elements, as indicated by the shaded rows and illustration above; otherwise, this information will be displayed in the RESP VS box

(see page 7-10).

13456

ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)7‐9

Changing the CO2 and CO2 (RESP) Alarm Limits

TheCO2(Et)andCO2(Fi)AlarmLimitsmenucanbeaccessedbytouchingthealarmlimitsettings

intheCO2VSbox.

TochangetheCO2(Et)andCO2(Fi)alarmlimitsettings

1Alarm limit settings, CO2 (Et), CO2 VS box

2High button

3Low button

4CO2 (Et) Alarm Limits menu label (active adjustment shown)

5CO2 (Fi) Alarm Limits menu label

6Enter button

7Current adjustment

8Alarm limit, minimum

9Lower alarm limit setting

10 Upper alarm limit setting

11 Alarm limit, maximum

Step Action

1 Selectthe(Et)CO2alarmlimitsettingsintheCO2VSbox.

TheCO2AlarmLimitsmenuappears.CurrentCO2(Et)settingsare

displayed.

2 SelecttheCO2alarmlimitsmenu,CO2(Et)orCO2(Fi),thatyou

wanttochange.

Theassociatedmenuappears.Currentsettingsaredisplayed.

3456

8 9 10 11

7‐10MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse

Atthedefaultsetting,theCO2(RESP)AlarmLimitsmenucanbeaccessedbytouchingthealarm

limitsettingsintheRESPVSbox.

3 SelecttheLowbuttonortheHighbutton.

Theselectedbuttonwillbehighlightedandthecurrentadjustment

willbedisplayed.

4Usingthekeypad,ortheincrement,decrement,orOffbuttons,

enterthedesiredsetting.

Thecurrentadjustmentwillreflectthesetting.

5PresstheEnterbuttontosavethesetting.

Thealarmlimitsettingisupdated.

Tochangetheremainingsettings,repeatsteps2–5.

Thecurrentadjustmentwillreflectthechange.

1High button

2Low button

3Alarm limit settings, CO2 (RESP), RESP VS box

4CO2 (RESP) Alarm Limits menu label

5Enter button

6Current adjustment

7Lower alarm limit setting

8Alarm limit, minimum

9Upper alarm limit setting

10 Alarm limit, maximum

Step Action

7 8 9 10

ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)7‐11

TochangetheCO2(RESP)alarmlimitsettings

Note

See chapter 4 for detailed alarm limit setting instructions and options.

Changing the Unit of Measure

Tochangetheunitofmeasure

Step Action

1 SelecttheCO2(RESP)alarmlimitsettingsintheRESPVSbox(or,in

theCO2VSbox,seepage7‐7.)

TheCO2(RESP)AlarmLimitsmenuappears.Currentsettingsare

displayed.

2 SelecttheLowbuttonortheHighbutton.

Theselectedbuttonwillbehighlightedandthecurrentadjustment

willbedisplayed.

3Usingthekeypad,ortheincrement,decrement,orOffbuttons,

enterthedesiredsetting.

Thecurrentadjustmentwillreflectthesetting.

4PresstheEnterbuttontosavethesetting.

Thealarmlimitsettingisupdated.

Tochangetheremainingsetting,repeatsteps2,3,and4.

Thecurrentadjustmentwillreflectthechange.

Step Action

1PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

2OntheMonitorSetupmenu,selectService(Bio‐Med).

TheService(Bio‐Med)sub‐menuappears.

3OntheService(Bio‐Med)menu,selectSystemConfig.

TheSystemConfigmenuappears.Currentsettingsaredisplayed.

7‐12MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse

CO2 Menu

TheCO2menuallowsyoutocontroltheCO2andCO2(RESP)monitoringfunctionsandsettings.

ToopentheCO2menu

SelecttheCO2VSbox.

4OntheSystemConfigmenu,selectGasUnits.

TheGasUnitsmenuappears.Thecurrentsettingishighlighted.

5 Selectthedesiredunitofmeasure:

mmHg

kPa

Thesettingischanged.

Step Action

CO2 VS box

CO2 menu

ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)7‐13

ThefollowingCO2menuitemsareavailable:

Note

Apnea and Apnea Time will be in the CO2 menu when bellows (BEL) is the selected RESP >

Source; see page 10-7 for setting details.

TochangesettingsintheCO2menu

Size

ControlsthesizeoftheCO2waveform.

Thefollowingoptionsareavailable:

•40mmHg(Default)

•60mmHg

•80mmHg

1Size

2Grids

3Zero Cal

Step Action

1 SelecttheCO2VSbox.

TheCO2menuappears.Currentsettingsaredisplayed.

2TouchthemenuitemtoselectoneofthefollowingCO2options:

Size

Grids

ZeroCal

Themenuitemappears.Thecurrentsettingishighlighted.

3 Selectthedesiredsettingfromthemenuoptions(exceptGrids,

whichisselectableontheCO2menu).

Thesettingisentered.

4Tochangeothersettings,repeatsteps2and3.

7‐14MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse

ToadjustthesizeoftheCO2waveform

Grids

Displaysascaledgrid,whichisgraduatedaccordingtotheSizeselectionfortheCO2waveform.

Thefollowingoptionsareavailable:

•Offdoesnotdisplayagrid.(Default)

•Ondisplaysagrid.

Note

Grids will not be displayed during a CO2 Accuracy Check; see page 3-30.

Step Action

1 SelecttheCO2VSbox.

TheCO2menuappears.Currentsettingsaredisplayed.

2 SelectSize.

TheSizemenuappears.Thecurrentsettingishighlighted.

3 Selectthedesiredsize:

40mmHg

60mmHg

80mmHg

Thesettingischanged.

Grid

Size

ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)7‐15

TocontrolthedisplayfunctionfortheCO2grid

Zero Cal

Initiatesazerocalibration(anautomaticfunctionduringnormaluse)oftheCO2systemtoallow

forthedifferentcharacteristicsofeachaccessorytype.ZeroCalisnotrequiredwhenswitching

samplinglines.

Undercertainconditions,ZeroCalwillnotbeallowed:

•Iflessthan20secondshavepassedsincedetectionofthelastbreath;

•IftheCO2temperatureisunstable;or

•IfthesamplinglineisdisconnectedfromtheCO2port.

Toperformazerocalibration

Seepage7‐2.

Step Action

1 SelecttheCO2VSbox.

TheCO2menuappears.Currentsettingsaredisplayed.

2LocateGridsandselectthedesiredsetting:

Off

Thesettingisentered.

7‐16MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse

ExpressionMR400InstructionsforUseMonitoringInvasiveBloodPressure8‐1

CHAPTER 8

Monitoring Invasive Blood Pressure

Whenequippedwiththeinvasivebloodpressureoption,theMR400providescompatibilitywith

standardinvasivebloodpressuretransducershavinga5µV/V/mmHgsensitivity,andofferstwo

invasivebloodpressurechannels,P1andP2.

Indications and Contraindications

Adult and Pediatric Patients

Indications

•Directarterialpressuremonitoring

•Leftatrialmonitoringwithanair‐eliminatingfilterbetweensolutionsourceandcontinuous

flushdevice

• Pulmonaryarterymonitoring(PAdistal)

•Venouspressuremonitoring(RAproximal)

•Cardiaccatheterization

Contraindications

•Leftatrialmonitoringwithoutanair‐eliminatingfilterbetweensolutionsourceand

continuousflushdevice

•Intracranialpressuremonitoring

• Compartmentalpressuremonitoring

•Intrauterinepressuremonitoring

Neonatal Patients

WARNING

Do not use a pressure administration cuff.

Indications

• Umbilicalarterycatheterizationofneonates

•Invasivepressuremonitoringwithinfusionpump

8‐2MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse

Contraindications

•Leftatrialmonitoringwithoutanair‐eliminatingfilterbetweenthesolutionsourceand

continuousflushdevice

•Intracranialpressuremonitoring

• Compartmentalpressuremonitoring

• Intrauterinepressuremonitoring

Patient Preparation for IBP Monitoring

Whenpositioningthepatient,routineIBPmeasurements(includingforthecondition

hypertension)requirethepatienttoremainsilent,stillandrelaxed,withlegsuncrossedandarms

supported.NotethatduringMRIprocedures,patientsaretypicallylayingdownwiththeirlegs

uncrossedandarmssupportedasneededfortheMRIscan.Wealsorecommendwaiting5

minutesbeforetakingreadings.

Transducer Component, Connection, and Feature Locations

Theillustrationbelowdetailsthepressuretransducer(REF989803179721)component,feature,

andconnectionlocations.Ifusingadifferentkit,refertothemanufacturersinstructionswhich

accompanythatkit.

1To patient

2Site line

3Zero reference stopcock

4Zero port

5Transducer

6Transducer cable

ExpressionMR400InstructionsforUseMonitoringInvasiveBloodPressure8‐3

MR 400 Preparation for IBP Monitoring

FollowtheprocedurebelowtopreparetheMR400forIBPmonitoringwhenusingtheExpression

MRIBPDPTKits(Adult/Pediatric,REF989803194631;and,Infant/Neonatal,REF989803194641).

Astherearepreparationdifferences,alwaysfollowtheappropriateprocedure.

TopreparetheMR400forIBPmonitoringusingtransducerkitsotherthanthosereferenced

below,orforcomponentsaddedtothemonitoringsystem,refertoapplicablemanufacturer’s

instructionsforsetupanduse.

WARNINGS

• Invasive blood pressure transducers are sensitive to vibrations that can occur during

MRI scanning, which can lead to pressure reading inaccuracies. Always mount the invasive

blood pressure transducer away from areas where vibration is likely to occur.

• The fluid within the pressure transducer system is a conductive connection to the

patient, and must not contact other conductive parts, including earth ground.

• Do not allow fluids to enter the electrical connections of the transducer cables. Erratic

readings may result.

• Always reference the manufacturer’s instructions and follow the safe use instructions

included with the IBP transducer kit when monitoring invasive blood pressure.

• Never attach the pressure transducer(s) directly to the patient as excessive heating can

occur resulting in burn injuries to the patient.

• If air bubbles appear in the tubing system, flush the system with the infusion solution

again. Air bubbles may lead to a wrong pressure reading.

• Transducers do not protect against burns when used with high-frequency (HF)

surgical equipment.

• A transducer cable or other cable that becomes inadvertently looped during an MRI

examination may act as conductive lines for RF induced currents, resulting in

excessive heating and possible burns. When transducer cables or other cables form a

conductive loop in contact with the patient's tissue, minor to severe burning can result.

Do not allow the transducer cable or other cable to touch the patient or to become

looped. Please refer to the additional information in Appendix E to prevent excessive

heating associated with MRI procedures.

7Press here to disconnect transducer from reusable cable

8Reusable cable connector

9Transducer cable connector

10 To fluid source

11 Squeeze continuous flush device

8‐4MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse

WARNING

Disposable attachments are designed for single patient use and must be disposed after use.

They must not be cleaned and reused. Follow your hospital’s guidelines for appropriate

disposal. Reuse of single-use devices can result in spread of patient infection, degradation of

monitoring performance, or inaccurate measurements.

CAUTION

Use only approved pressure transducers and cables, as listed in Accessories in chapter 1, and

follow the Instructions for Use that are supplied with the pressure transducer to set up and use the

transducer monitoring kit.

Note

The procedure below details the connection of a single transducer. To monitor two IBP channels,

repeat the procedure to connect an additional transducer to the unused IBP port on the MR400.

Adult and Pediatric Patients: Expression MR IBP DPT Kit, A/P (REF 989803194631)

I. Connecting the Reusable Cable to the MR400

Connectthereusablecable,REF989803194601(orequivalent),totheP1ortheP2portonthe

patientconnectionpanel.

P2 port

Reusable cable

(REF 989803194601, or equivalent)

P1 port

ExpressionMR400InstructionsforUseMonitoringInvasiveBloodPressure8‐5

II. Kit Set Up

Setupthedisposabletransducermonitoringkitusingaseptictechnique.

Step Action

1Openpackagecontainingthesteriledisposabletransducer

monitoringkit.

2 Removetransducermonitoringkitassemblyfromthepackage.

Checkallfittingstoensuretightconnection.

3Connectthereusablecable,REF989803194601(orequivalent),to

thetransducercable.

4 PrepareacollapsibleI.V.solutionbagbyextractingallairfromthe

bag.Ifheparinizing,addheparinpriortoairremoval.

CAUTION

If an air-free solution source is not used (i.e., air is not extracted

from the fluid source), air may be forced into the monitoring line

when solution is exhausted.

5Closetheclampontheadministrationsetandremovethe

protectivecapfromtheadministrationsetspike.Insertthespike

carefullyintotheI.V.solutionbag.

CAUTION

To prevent inadvertent puncture of the I.V. solution bag, insert the

spike carefully using a twisting motion.

Transducer

Reusable cable

(REF 989803194601, or equivalent)

Transducer cable

8‐6MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse

III. Purging Air from the Monitoring Line

A. AttachthetransducertoanMRIVpolemount.

B.Turnzeroreferencestopcock“off”topatient.Removewhiteventedcapfromthesideport

ofthezeroreferencestopcock.

C.Activatefastflushmechanismofthecontinuousflushdeviceandfilltransducerslowly

(gravityprimeonly)untilair‐free.Flushfluidthroughtransducerandsideportofstopcock.

D.Turnhandleofzeroreferencestopcock“off”toitssideport.Placeayellownon‐ventedcap

ontothesideportofthestopcock.

E.RepeatprimingstepsB–Dforanyadditionalstopcocks.

F.Removewhitecoveratpatientconnectorandflushtherestofthepatientline.Placea

yellownon‐ventedcoverontothepatientconnector.

Note

Take care to ensure no air is trapped in any components of the fluid pathway. The monitoring

system must be totally air-free for maximum performance, i.e., optimal dynamic response.

G.PressurizetheI.V.solutionsourceto300mmHg.Closeclamponpressurecuff.

CAUTIONS

• Make certain the drip chamber does not completely fill during pressurization. Air should

remain in the drip chamber so that the continuous flush rate can be verified following a fast

flush.

• Pulling a vacuum to purge bubbles from the lines is not recommended. This practice may

entrain air or release air from solution. If the line is primed in a forward manner under

pressure, care must be taken to assure the maximum pressure specifications for the

transducer are not exceeded.

6InserttheI.V.solutionbagintothepressureadministrationcuff.

7HangthepressureadministrationcufffromanMRI.V.pole.

8Withtheadministrationsetclampclosed,gentlysqueezethedrip

chamberandfilldripchamberapproximately1/2full.

9Openclamponadministrationset.

Step Action

ExpressionMR400InstructionsforUseMonitoringInvasiveBloodPressure8‐7

IV. Zeroing, Leveling and Calibration

A. Afterthesystemhasbeenprimedandmounted,zerothetransducerusingoneofthe

followingmethods:

—Or—

Step Action

1Turnthezeroreferencestopcock“off”tothepatientandremove

yellownon‐ventedcapfromthesideportwhichopensthezero

referencestopcocktoair.

Note

The air-fluid interface of the zero reference stopcock should be at or

near the right atrial (mid-axillary) level.

2Zerothetransducer.PresstheZeroAllkey.(Otherwise,tozeroa

singlechannel,useZeroSetintherespectiveP1orP2menu;see

page8‐24).

ZeroingAllPressureChannels(orZeroingPressureChannelfora

singlechannelifZeroSetwasused)willbedisplayedandzeroing

willbegin;where,uponcompletion,Donewillbedisplayedto

indicatesuccess.

Note

If the transducer will not zero and an error condition occurs, verify

that the transducer is being used as described in the manufacturer’s

instructions. Press Retry to attempt zeroing again. If the transducer

still does not zero, try another transducer and/or cable; and, if

condition persists, contact technical support or authorized service

personnel.

3Turnthezeroreferencestopcock“off”tothesideportandreplace

yellownon‐ventedcap.

Step Action

1 Attachdesiredcathetertodistalendofmonitoringkitandprime,

purgingallairbubblesfromcatheter.

2Openstopcock(s)tothecatheter.(Thecathetertipisnowthe

systemair‐fluidinterface.)

8‐8MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse

B. Repeatthiszeroing,leveling,andcalibrationprocedureforeachadditionalmonitoringline

asapplicable.

C. Transducersarepre‐calibratedtoindustrystandards.

V. Connecting the Monitoring Kit to the Patient

WARNING

The IBP transducer must not be mounted to the patient, or patient burn may result.

A. Removeyellownon‐ventedcoveratpatientconnector.Acontinuousflushofapproximately

3mlperhourshouldbeobservedinthedripchamber.Droprateshouldbeapproximately1

dropperminute.Foreachadditionalmonitoringline,thecontinuousflushwillincreaseby3

ml/hr(i.e.,6ml/hrfortwolines).

B. Forasystemicarterialbloodpressureline,activatethefastflushmechanismofthe

continuousflushdevice,whileallowingarterialcannulatobackflowduringattachment.For

pulmonaryarterycatheters,themonitoringkitshouldbeattachedtothecatheterandthe

3Placetransducerintheposition(horizontalplane)itwillmaintain

duringpressuremeasurement.

4Placethecathetertipattherightatrial(mid‐axillary)level.

5Zerothetransducer.Zerothetransducer.PresstheZeroAllkey.

(Alternatively,useZeroSetintherespectiveP1orP2menutozero

aspecificchannelconnectedtothetransducer;seepage8‐24).

ZeroingAllPressureChannels(orZeroingPressureChannelfora

singlechannelifZeroSetwasused)willbedisplayedandzeroing

willbegin;where,uponcompletion,Donewillbedisplayedto

indicatesuccess.

Note

If the transducer will not zero and an error condition occurs, verify

that the transducer is being used as described in the manufacturer’s

instructions. Press Retry to attempt zeroing again. If the transducer

still does not zero, try another transducer and/or cable; and, if

condition persists, contact technical support or authorized service

personnel.

Step Action

ExpressionMR400InstructionsforUseMonitoringInvasiveBloodPressure8‐9

catheterfilledwithI.V.solutionpriortoinsertion.Followcathetermanufacturer’sinsertion

instructions.

VI. Fast Flushing

A. Activatethefastflushmechanismofthecontinuousflushdeviceandcheckdripchamberto

confirmfastflush.

B. FOLLOWINGEACHFASTFLUSH,DRIPCHAMBERDROPRATEMUSTBEOBSERVEDTO

VERIFYCOMPLETECLOSURE.

VII. Checking for Leaks

Afterapproximately1minutehaselapsed,theflowrateshouldbeobservedatthedripchamber

toensurethatthecontinuousflushdeviceisoperatingproperly.Avisualinspectionforleaks

shouldalsobemadesinceasmallleakcanmisrepresenttheactualcontinuousflowthroughthe

catheter.Aprotocolshouldbeestablishedaccordingtothehospitalstandardofcareforroutinely

checkingthesystemforproperfluidsourcepressure,flowrateandleaks.

VIII. In the MR Room

WARNINGS

•The IBP transducer must not be allowed past the 5,000 gauss line, or transducer

failure, inaccurate readings, noisy MRI images or patient burn may result.

• Never place the pressure transducer’s stopcocks or port covers within 8 cm (3.2

inches) of the field of view of the MR bore as inaccurate readings or noisy MRI images

can result.

• An offset occurs when the pressure transducer is repositioned in the magnetic field.

The transducer must be zeroed prior to the MRI examination after the transducer is in

its final setup position. Moving the transducer after zeroing may cause a measurement

offset to occur.

IntheMRroom,ensurethatthetransducerislevelwiththeheartthatthetransducerinterface

cablingisnotloopedortouchingthepatient(refertheWarningsonpages8‐3and8‐4),andthen

re‐zerothetransducer;seepage8‐16.

WARNING

Non-physiological pulsatile P1 (or P2) waveform (for example, those found during intra-

aortic balloon pump use) can lead to inaccurate blood pressure readings. If questionable

values are observed, recheck the patient’s pressures by alternate means before administering

medication or therapy.

8‐10MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse

Note

When monitoring invasive blood pressure, routinely inspect the catheter and/or pressure line for

leaks after zeroing, and always follow the pressure transducer/catheter manufacturer’s use

recommendations.

Neonatal Patients: Expression MR IBP DPT Kit, I/N (REF 989803194641)

I. Connecting the Reusable Cable to the MR400

Connectthereusablecable,REF989803194601(orequivalent),totheP1ortheP2portonthe

patientconnectionpanel.

II. Kit Set Up

A. Setupthedisposabletransducermonitoringkitusingaseptictechnique

Step Action

1Openpackagecontainingthesteriledisposabletransducermonitor‐

ingkit.

2 Removetransducermonitoringkitassemblyfrompackage.

3 Attachadditionalmonitoringcomponentsasdesired.

4Checkallfittingstoensuretightconnections.

P2 port

Reusable cable

(REF 989803194601, or equivalent)

P1 port

ExpressionMR400InstructionsforUseMonitoringInvasiveBloodPressure8‐11

B. PreparingSolution

Note

If an air-free solution source is not used (i.e., air is not extracted from the fluid source), air may

be forced into the monitoring line when solution is exhausted.

5Connectthereusablecable,REF989803194601(orequivalent),to

thetransducercable.

Step Action

1 Assemblepumpadministrationsetappropriatefortheinfusion

pumpthatistobeused.

2Ifusingheparin,addpriortoairremoval.

CAUTION

If an air-free solution source is not used (i.e., air is not extracted

from the fluid source), air may be forced into the monitoring line

when solution is exhausted.

3 Attachtubingtosolutioncontainerandprimethetubingfollowing

pumpmanufacturer’sinstructions.

Step Action

Transducer

Reusable cable

(REF 989803194601, or equivalent)

Transducer cable

8‐12MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse

C. ConnectingKittotheInfusionPump

III. Purging Air from the Monitoring Line

A.Removetheventedcapfromthestopcocksandtheventedcoverfromthepatientconnector

(distalstopcock).

B.Adjustthepumpdeliveryregulatortoafluidflowratesufficienttoflushsolutionthroughthe

system.

C.CarefullyfillfluidlinesofthemonitoringkitwithI.V.solutionuntilallairhasbeenremoved

fromthesystem.Activateflushdevicetofacilitatefillingandtoremoveairfromflushdevice.

Turnstopcockhandlesasapplicabletoprimethroughsideportsofstopcocks.Non‐vented

capsandcoversareprovidedinthesparepartsbagtoreplaceventedcapsandcoversas

required.

CAUTION

Pulling a vacuum to purge bubbles from the lines is not recommended. This practice may entrain

air or release air from solution. If the line is primed in a forward manner under pressure, care must

be taken to assure the maximum pressure specifications for the transducer are not exceeded.

Note

Take care to ensure no air is trapped in any components of the fluid pathway. The monitoring

system must be totally air-free for maximum performance, i.e., optimal dynamic response.

IV. Zeroing, Leveling and Calibration

A. Afterthesystemhasbeenprimedandmounted,zerothetransducerusingoneofthe

followingmethods:

Step Action

1 Removeventedcapfromthefemaleportofflushdeviceandcon‐

nectflushdevicefluidlinetodistalconnectorofinfusionpump

administrationset.

CAUTION

In this application, the flush device is not intended to control flow

rate. Flow rate must be controlled by an infusion pump. Do not use

with pressure administration cuff.

ExpressionMR400InstructionsforUseMonitoringInvasiveBloodPressure8‐13

—Or—

Step Action

1Turnthezeroreferencestopcock“off”tothepatientandremove

non‐ventedcapfromthesideportwhichopensthezeroreference

stopcocktoair.

Note

The air-fluid interface of the zero reference stopcock should be at or

near the right atrial (mid-axillary) level.

2Zerothetransducer.PresstheZeroAllkey.(Otherwise,tozeroa

singlechannel,useZeroSetintherespectiveP1orP2menu;see

page8‐24).

ZeroingAllPressureChannels(orZeroingPressureChannelfora

singlechannelifZeroSetwasused)willbedisplayedandzeroing

willbegin;where,uponcompletion,Donewillbedisplayedto

indicatesuccess.

Note

If the transducer will not zero and an error condition occurs, verify

that the transducer is being used as described in the manufacturer’s

instructions. Press Retry to attempt zeroing again. If the transducer

still does not zero, try another transducer and/or cable; and, if

condition persists, contact technical support or authorized service

personnel.

3Turnthezeroreferencestopcock“off”tothesideportandreplace

non‐ventedcap.

Step Action

1 Attachdesiredcathetertodistalendofmonitoringkitandprime,

purgingallairbubblesfromcatheter.

2Openstopcock(s)tothecatheter.(Thecathetertipisnowthesys‐

temair‐fluidinterface.)

3Placetransducerintheposition(horizontalplane)itwillmaintain

duringpressuremeasurement.

4Placethecathetertipattherightatrial(mid‐axillary)level.

8‐14MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse

B. Transducersarepre‐calibratedtoindustrystandards.

V. Connecting the Monitoring Kit to the Patient

WARNING

The IBP transducer must not be mounted to the patient, or patient burn may result.

A. Removenon‐ventedcoveratpatientconnector.

B. Settheinfusionpumptodeliverthedesiredflowrate.Continuouslowflowflushshouldbe

observedatthepatientconnectoranddripchamber(ifprovided)atthistime.

CAUTION

Kits with a 30 ml per hour flush device are not intended to control flow rate. Flow rate must be

controlled by an infusion pump. Do not use with pressure administration cuff.

C. Activatepumpdeliverymechanismtopumpsolutionthroughtheflushdevicewhileallowing

arterialcannulatobackflowduringattachment.

5Zerothetransducer.PresstheZeroAllkey.(Alternatively,useZero

SetintherespectiveP1orP2menutozeroaspecificchannel

connectedtothetransducer;seepage8‐24).

ZeroingAllPressureChannels(orZeroingPressureChannelfora

singlechannelifZeroSetwasused)willbedisplayedandzeroing

willbegin;where,uponcompletion,Donewillbedisplayedto

indicatesuccess.

Note

If the transducer will not zero and an error condition occurs, verify

that the transducer is being used as described in the manufacturer’s

instructions. Press Retry to attempt zeroing again. If the transducer

still does not zero, try another transducer and/or cable; and, if

condition persists, contact technical support or authorized service

personnel.

Step Action

ExpressionMR400InstructionsforUseMonitoringInvasiveBloodPressure8‐15

CAUTIONS

• Be certain not to introduce air into the system during connection procedure.

• If this product is used with fat emulsions, they must be introduced through the lipid

compatible stopcock that is distal to the flush transducer assembly to avoid cracking of the

transducer line.

VI. Checking for Leaks

Afterapproximately1minutehaselapsed,theflowrateshouldbeobservedatthedripchamber

toensurethatthecontinuousflushdeviceisoperatingproperly.Avisualinspectionforleaks

shouldalsobemadesinceasmallleakcanmisrepresenttheactualcontinuousflowthroughthe

catheter.Aprotocolshouldbeestablishedaccordingtothehospitalstandardofcareforroutinely

checkingthesystemforproperfluidsourcepressure,flowrateandleaks.

VII. In the MR Room

WARNINGS

•The IBP transducer must not be allowed past the 5,000 gauss line, or transducer

failure, inaccurate readings, noisy MRI images or patient burn may result.

• Never place the pressure transducer’s stopcocks or port covers within 8 cm (3.2

inches) of the field of view of the MR bore as inaccurate readings or noisy MRI images

can result.

• An offset occurs when the pressure transducer is repositioned in the magnetic field.

The transducer must be zeroed prior to the MRI examination after the transducer is in

its final setup position. Moving the transducer after zeroing may cause a measurement

offset to occur.

IntheMRroom,ensurethatthetransducerislevelwiththeheartthatthetransducerinterface

cablingisnotloopedortouchingthepatient(refertotheWarningsonpages8‐3and8‐4),and

thenre‐zerothetransducer;seepage8‐16.

WARNING

Non-physiological pulsatile P1 (or P2) waveform (for example, those found during intra-

aortic balloon pump use) can lead to inaccurate blood pressure readings. If questionable

values are observed, recheck the patient’s pressures by alternate means before administering

medication or therapy.

8‐16MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse

Note

When monitoring invasive blood pressure, routinely inspect the catheter and/or pressure line for

leaks after zeroing, and always follow the pressure transducer/catheter manufacturer’s use

recommendations.

Zeroing the Pressure Transducer

WARNING

The transducer must be zeroed prior to the MRI examination after the transducer is in its

final setup position. Moving the transducer after zeroing may cause a measurement offset to

occur. Otherwise, inaccurate patient pressure readings may result.

Toavoidinaccuratepressurereadings,themonitorrequiresavalidzero.Zerothetransducerin

accordancewithyourhospitalpolicy(atleastonceperday).Youmustperformazero:

•whenyouuseanewtransducerortubing,

•everytimeyoureconnectthetransducercabletothemonitor,or

•ifyouthinkthemonitor’spressurereadingsarenotcorrect.

Tozeroapressuretransducer

Refertotheappropriateprocedureaccordingtothepatienttypeandapplication:

•Adult/Pediatric—seepage8‐7.

•Neonate—seepage8‐12.

P1 and P2 Waveforms and VS Boxes

Invasivebloodpressuremeasurements(P1andP2)aredisplayedaswaveforms(traceEandtrace

F,respectively)intheVStraceareaofthescreenandasnumericinformationintheP1andP2VS

boxes.Otherdata,includingP1‐andP2‐relatedalarminformation,arealsoprovidedinthese

areasofthescreen,asdetailedbelow.

ExpressionMR400InstructionsforUseMonitoringInvasiveBloodPressure8‐17

Note

Except for the VS box annotations and waveform locations, the definitions described below are

applicable to both P1 and P2 channels.

Systolic/Diastolic Format

11 10

Item Name Definition

1 P1 VS waveform, or P2 VS

waveform

Is the detected P1 (or P2) waveform, Trace E (or Trace F)

Note

To change the waveform speed, see Sweep Speed on page 3-25.

2 Alarm flag area Displays P1 (or P2) alarm flags when detected; see page 4-31.

3 P1 (or P2) VS box label Indicates the P1 (or P2) vital sign parameter, and accesses the P1 menu (or P2

menu)

4 Unit of measure Indicates that the pressure measurement numeric values are given in mmHg

(millimeters of mercury) or kPa (kilopascals); see Pressure Units on page 3-32.

5 Systolic numeric Is the patient’s detected systolic invasive blood pressure measurement

6 Diastolic numeric Is the patient’s detected invasive diastolic blood pressure measurement

7 Systolic upper alarm limit Is the upper limit setting for the P1 (or P2) systolic alarm, and accesses the P1

Alarm Limits menu (or the P2 Alarm Limits menu)

8 Diastolic upper alarm limit Is the upper limit setting for the P1 (or P2) diastolic alarm, and accesses the P1

Alarm Limits menu (or the P2 Alarm Limits menu)

8‐18MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse

Mean Format

9 Diastolic lower alarm limit Is the lower limit setting for the P1 (or P2) diastolic alarm, and accesses the P1

Alarm Limits menu (or the P2 Alarm Limits menu)

10 Systolic lower alarm limit Is the lower limit setting for the P1 (or P2) systolic alarm, and accesses the P1

Alarm Limits menu (or the P2 Alarm Limits menu)

11 Mean numeric Indicates the patient’s detected mean invasive blood pressure measurement

12 <P1 label> or <P2 label> Indicates the Set Label name, if assigned, for P1 (or P2)

Item Name Definition

123

10 9

Item Name Definition

1 P1 VS waveform, or P2 VS

waveform

Is the detected P1 (or P2) waveform, Trace E (or Trace F)

Note

To change the waveform speed, see Sweep Speed on page 3-25.

2 Alarm flag area Displays P1 (or P2) alarm flags when detected; see page 4-31.

3 P1 (or P2) VS box label Indicates the P1 (or P2) vital sign parameter, and accesses the P1 menu (or P2

menu)

4 Unit of measure Indicates that the pressure measurement numeric values are given in mmHg

(millimeters of mercury) or kPa (kilopascals); see Pressure Units on page 3-32.

5 Mean numeric Is the patient’s detected mean invasive blood pressure measurement

6 Mean upper alarm limit Is the upper limit setting for the P1 (or P2) mean alarm, and accesses the P1 Alarm

Limits menu (or the P2 Alarm Limits menu)

ExpressionMR400InstructionsforUseMonitoringInvasiveBloodPressure8‐19

Changing the P1 (or P2) Format

TocontroltheformatoftheP1(orP2)data

Changing the P1 (or P2) Waveform Amplitude

TheverticalscaleofthedisplayedP1(orP2)waveformcanbechangedtobestsuittheviewing

requirements.Alwaysselecttheappropriatewaveformscaleforthewaveformbeingobserved.

7 Mean lower alarm limit Is the lower limit setting for the P1 (or P2) mean alarm, and accesses the P1 Alarm

Limits menu (or the P2 Alarm Limits menu)

8 Diastolic numeric Is the patient’s detected invasive diastolic blood pressure measurement

9 Systolic numeric Indicates the patient’s detected systolic invasive blood pressure measurement

10 <P1 label> or <P2 label> Indicates the Set Label name, if assigned, for P1 (or P2)

Item Name Definition

Step Action

1 SelecttheP1(orP2)VSbox.

TheP1menu(ortheP2menu)appears.Currentsettingsare

displayed.

2 SelectFormat.

TheFormatmenuappears.Thecurrentsettingishighlighted.

3 Selectthedesiredformat:

SysDia

Mean

Theformatischanged.

Note

When using P1 (or P2) labels CVP or ICP, the displayed format

cannot be changed; see page 8-28 for details.

8‐20MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse

TochangetheP1(orP2)waveformamplitude

Changing the P1 (or P2) Alarm Limits

TheP1AlarmLimitsmenucanbeaccessedbytouchingthealarmlimitsettingsintheP1vitalsign

box,andtheP2AlarmLimitsmenucanbeaccessedbytouchingthealarmlimitsettingsintheP2

vitalsignbox.Exceptformenulabelingdifferences,theelementsdescribedbelowareapplicable

toboththeP1andP2parameters.

Step Action

1 SelecttheP1(orP2)VSbox.

TheP1(orP2)menuappears.Currentsettingsaredisplayed.

2 SelectSize.

TheSizemenuappears.Thecurrentsettingishighlighted.

3 Selectthedesiredsize:

40mmHg

75mmHg

100mmHg

150mmHg(Default)

200mmHg

250mmHg

Thesettingischanged.

1Alarm limit settings, P1 VS box

2High button

3Low button

4 P1 Diastolic Alarm Limits menu label

5P1 Mean Alarm Limits menu label

6Enter button

35 46

8 9 10 11 12

ExpressionMR400InstructionsforUseMonitoringInvasiveBloodPressure8‐21

Tochangetheinvasivebloodpressurealarmlimitsettings

Note

See chapter 4 for detailed alarm limit setting instructions and options.

7Current adjustment

8P1 Systolic Alarm Limits menu label (active adjustment shown)

9Alarm limit, minimum

10 Lower P1 (Sys) alarm limit setting

11 Upper P1 (Sys) alarm limit setting

12 Alarm limit, maximum

Step Action

1 SelectthealarmlimitsettingsintheP1(orP2)VSbox.

TheP1AlarmLimits(ortheP2AlarmLimits)menuappears.

Currentsettingsaredisplayed.

2 Selectthedesiredpressuresetting:

P1(Sys)

P1(Dia)

P1(Mean)

Thesettingisselected.

3 SelecttheLowbuttonortheHighbutton.

Theselectedbuttonwillbehighlightedandthecurrentadjustment

willbedisplayed.

4Usingthekeypad,ortheincrement,decrement,orOffbuttons,

enterthedesiredsetting.

Thecurrentadjustmentwillreflectthechange.

5PresstheEnterbuttontosavethesetting.

Thealarmlimitsettingisupdated.

Tochangetheremainingsettings,repeatsteps2,3,4and5.

Thecurrentadjustmentwillreflectthechange.

8‐22MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse

Changing the Unit of Measure

Note

When using an IP5 and Pressure Units is changed, the displayed formatting of the value and

placement of the decimal point is changed immediately. However, it can take up to 2 seconds for

the measurement numeric values to reflect the new unit of measure. Do not print or perform data

captures during this period.

Tochangetheunitofmeasure

P1 (and P2) Menu

TheP1andP2menusallowyoutocontrolinvasivebloodpressuretraces,functionsandsettings.

Eachmenucontainsidenticaloptionsforthecontroloftherespectiveinvasivebloodpressure

channel,P1orP2.

Note

The operation and menus for P1 and P2 are identical.

Step Action

1PresstheSetupkeyandthentheMonitorkey.

TheMonitorSetupmenuappears.Currentsettingsaredisplayed.

2OntheMonitorSetupmenu,selectService(Bio‐Med).

TheService(Bio‐Med)menuappears.Currentsettingsare

displayed.

3OntheService(Bio‐Med)menu,selectSystemConfig.

TheSystemConfigmenuappears.Currentsettingsaredisplayed.

4OntheSystemConfigmenu,selectPressureUnits.

ThePressureUnitsmenuappears.Thecurrentsettingis

highlighted.

5 Selectthedesiredsetting:

mmHg

kPa

Thesettingisentered.

ExpressionMR400InstructionsforUseMonitoringInvasiveBloodPressure8‐23

ToopentheP1menu(orP2menu)

SelecttheP1VSbox(ortheP2VSbox).

ThefollowingP1(andP2)menuitemsare

available:.

TochangesettingsintheP1(orP2)menu

1Zero Set

2Set Label

3Size

4HR Source

5Grids

6Grids Size

7Format

Step Action

1 SelecttheP1(orP2)VSbox.

TheP1(orP2)menuappears.Currentsettingsaredisplayed.

P1 menu

P1 VS box

8‐24MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse

Zero Set

ZerosthepressuretransducerforP1(orP2).Thepressuretransducermustbezeroedbeforeuse

andatregularintervalsduringuse.(ZeroPressureChannelwillbedisplayedduringtheprocess

andDonewillbedisplayeduponcompletion.)

Tozerothepressuretransducer

SeeZeroingthePressureTransduceronpage8‐16.

Set Label

Assignsalabeltothepressurechannelforidentificationofthetransducersite.Thelabelwill

appearintheVSboxanditwillalsodeterminethecolorusedfortheVSbox.

Thefollowingnamesandcolorsareavailable:

•Nonedisplayedinwhite.(Default)

•ABP(arterialbloodpressure)displayedinpink.

Note

In the event ABP is chosen as the heart rate source while there are multiple pressures labeled as

ABP, the system will choose P1.

•PAP(pulmonaryarterypressure)displayedinyellow.

2TouchthemenuitemtoselectoneofthefollowingP1(orP2)

options:

ZeroSet

SetLabel

Size

HRSource

Grids

GridsSize

Format

Themenuitemappears.Thecurrentsettingishighlighted.

3 Selectthedesiredsettingfromthemenuoptions(exceptGrids,

whichisselectableontheP1[orP2]menu):

Thesettingisentered.

4Tochangeothersettings,repeatsteps2and3.

Step Action

ExpressionMR400InstructionsforUseMonitoringInvasiveBloodPressure8‐25

•CVP(centralvenouspressure)displayedinblue.

•LAP(leftatrialpressure)displayedinpurple.

•ICP(intracranialpressure)displayedinlightblue.

ToassignalabeltoanP1(orP2)channel

Size

ChangestheP1(orP2)waveformamplitude,allowinglowlevelsignalstobescaleduporhigh

levelsignalstobescaleddownforbetterviewing.

Thefollowingoptionsareavailable:

•40mmHg

•75mmHg

•100mmHg

•150mmHg(Default)

•200mmHg

•250mmHg

TochangetheamplitudeoftheP1(orP2)waveform

SeeChangingtheP1(orP2)WaveformAmplitudeonpage8‐19.

Step Action

1 SelecttheP1(orP2)VSbox.

TheP1menu(ortheP2menu)appears.Currentsettingsare

displayed.

2 SelectSetLabel.

TheSetLabelmenuappears.Thecurrentsettingishighlighted.

3 Selectthedesiredlabel:

None

ABP

PAP

CVP

LAP

ICP

Thelabelischanged.TheannotationintheVSboxanditscoloris

updated.

8‐26MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse

HR Source

Selectsthesourcethatproducestheheartrate,asdisplayedintheECGandSPO2VSboxes

(identicaltoandinteractivewithsameoptionintheECGandSPO2menus).

Thefollowingoptionsareavailable:

•Autosetsthesourceautomaticallyaccordingtothehighestpriorityactiveinputthatisfirst

toreportvalidpatientdata.Thepriorityranking(highesttolowest)isECG,P1,P2,SPO2

(providedthattheP1andP2channelshavebeenlabeledABP;seeSetLabelonpage8‐24

fordetails).Thesourcewillbecomeunavailablewhenithasproducednovaliddatafora

periodoften(10)ormoreseconds.Thesystemexaminesthehighestpriorityactiveinput.

Ifnotfound,thesecond‐highestpriorityinputischosen,etcetera.Ifnonearepresent,

thenNoneisdisplayedastheheartratemeasurementnumeric.

•ECGsetsECGasthesource.(Default)

•ABPsetsABPasthesource(ifnopressurechannelislabeledABP,awarningboxwillallow

automaticrenamingandselectionbeforeproceeding;alsoseeSetLabelonpage8‐24).

•SPO2setsSPO2asthesource.

Tosettheheartratesource

Grids

ControlsthepressuregriddisplayforIBPwaveforms.

Step Action

1 SelecttheP1(orP2)VSbox.

TheP1menu(ortheP2menu)appears.Currentsettingsare

displayed.

2 SelectHRSource.

TheHRSourcemenuappears.Thecurrentsettingishighlighted.

3 Selectthedesiredsettingfortheheartratesource:

Auto

ECG

ABP

SPO2

Thesourceischanged.

ExpressionMR400InstructionsforUseMonitoringInvasiveBloodPressure8‐27

Thefollowingoptionsareavailable:

•Offnogridisdisplayed.(Default)

•Ondisplaysascaledgrid(alsoseeGridsSize,below).

Tocontrolthedisplayfunctionforthepressuregrid

Grids Size

SetsthescalesizewhenGridsison(seeGrids,above).

Thefollowingoptionsareavailable:

•40mmHg

•75mmHg

•100mmHg

•150mmHg(Default)

•200mmHg

•250mmHg

Grid

Grids Size

Step Action

1 SelecttheP1(orP2)VSbox.

TheP1menu(ortheP2menu)appears.Currentsettingsare

displayed.

2LocateGridsandselectthedesiredsetting:

Off

Thesettingisentered.

8‐28MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse

ToadjustthegridsizefortheP1(orP2)waveform

Format

SetsthedisplayedformatoftheP1(orP2)numericdata,exceptwhenusingcertainpressure

channellabels.

Thefollowingoptionsareavailable:

•SysDiadisplaysthesystolicanddiastolicnumericsinalargefont(separatedbyaslash)and

displaysthemeannumericinasmallerfont(bracketedwithparenthesis).(Default)

•Meandisplaysthemeannumericinalargefont,andthesystolicanddiastolicnumericsin

asmallerfontandseparatedbyaslash.Onlymeanalarmswillbepresentinthisformat.

Also,labels(i.e.,CVPandICP)thatdesignatesinglepressureswillautomaticallyassumethe

meanformat;seeSetLabelonpage8‐24.

TocontroltheformatoftheP1(orP2)numericdata

SeeChangingtheP1(orP2)Formatonpage8‐19.

Step Action

1 SelecttheP1(orP2)VSbox.

TheP1menu(ortheP2menu)appears.Currentsettingsare

displayed.

2 SelectGridsSize.

TheGridsSizemenuappears.Thecurrentsettingishighlighted.

3 Selectthedesiredsize:

40mmHg

75mmHg

100mmHg

150mmHg

200mmHg

250mmHg

Thesettingischanged.

ExpressionMR400InstructionsforUseMonitoringAgentsandGases(AGENTOption)9‐1

CHAPTER 9

Monitoring Agents and Gases (AGENT Option)

WhenequippedwiththeAGENToption,thepatient’slevelofanestheticagentgases,oxygen

(O2),carbondioxide(CO2),andnitrousoxide(N2O)concentrationscanbemonitored.An

anestheticgassensor(AGS)systemusesinfraredspectroscopycombinedwithdigitalsignal

processingtoquicklyandaccuratelyidentifygasconcentrations.

WARNING

Whenever a patient is under anesthesia or connected to a ventilator, constant attention by

qualified medical personnel is required.

MR400 Preparation for AGENT Monitoring

WhenpreparingtheMR400forAGENTmonitoring,ensurethatthewastegasport(seepage1‐

19)hasbeenconnectedtoyourfacility’sgasscavengingsystemfordisposalofsampledand

calibrationgases.

Notes

• These instructions are for setting up a typical monitoring system. Exact components and set-

up procedure used may vary, depending upon the application. For components added to the

monitoring system, refer to applicable manufacturer’s instructions for set up and use.

• Never route the waste gas tubing in a location that will allow it to be an obstruction or

stepped on.

Operation and Use

Whenmonitoringanestheticagentgases,thetypicaloperationsandpossibleconditionsthatcan

arisemayresultinpotentialmessagesrequiringyourattention.Seepage4‐26foramessage

listingandsuggestedactions.

9‐2MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse

WARNINGS

•Organic vapors (for example, from cleaning agents) in the sampling line or room air

may alter anesthetic agent readings.

• Alcohol in the patient’s breath can modify the anesthetic agent readings.

Warm-Up Period

Inordertoachieveaccurateidentificationsandmeasurements,theAGSsystemrequiresawarm‐

upperiodtothermallystabilize.Thiswarm‐upperiodbeginswhentheAGENTortheCO2

parameterisactivated.Uponactivation,theAGSsystemwillbecomefullyoperationalaccording

tothefollowingsequence:

1. Duringthewarm‐upperiod,CO2WarmingUpwillbedisplayed.

2. Within45secondsofactivation,theAGSsystemwillbeabletoidentifythegasesand

providegasconcentrationinformationwithISO‐levelaccuracy.Waitduringthisperiod,the

measurementnumericvaluesintheAGENT,GAS,andCO2VSboxeswilldisplaythree

dashes(‐‐‐);seeNoDataIndicationonpage2‐20fordetails.

3. Within10minutesofactivation,theAGSsystemwillbeabletooperateatfullaccuracy.

Zero Reference Adjustment

WARNING

During Zero calibration the system pulls ambient air through the zero intake port on the cart

The calibration system assumes that the ambient air will contain normal trace amounts of

CO2. If the system is placed in an unventilated area that allows CO2 (from the waste gas port

on the rear panel, if not connected to a gas scavenging system) to accumulate, the result could

be inaccurate CO2 zeroing and resulting inaccurate patient readings. Always place the cart in

a well ventilated area.

TheAGSsystemwilloccasionallyperformazeroreferenceadjustment,brieflyinterruptinggas

monitoringtotakeinroomairthroughareferencegasintakeporttoensuretheaccuracyofthe

displayedgasconcentrations.

ReadjustingCO2Zerowillbedisplayedduringazeroreferenceadjustment;allowtheprocessto

complete.Azeroreferenceadjustmenttypicallytakes10–12seconds,andwilloccur

automaticallyasneeded,butmostlyduringthewarm‐upperiod.WhentheAGSsystemhas

becomefullyoperational,theseadjustmentswilloccurapproximatelyonceevery4hoursor

whenevertheAGSsystemtemperaturechangesbyatleast±1°Cfromthelaststoredstable

temperature.

ExpressionMR400InstructionsforUseMonitoringAgentsandGases(AGENTOption)9‐3

Note

Whenever the Agent sensor changes from a steady state condition, the system will perform an zero

reference adjustment to restabilize the sensor readings. During this time it is possible for a false

identification and concentration value to occur. Change from a steady state condition may occur

when:

– Applying a sampling line for the first time.

– Switching from one agent to another.

– Going from high agent concentrations to low or off.

Note

During the first hour after the system has been turned on and flowing oxygen greater than 50

percent, the CO2 waveform periodically baselines to complete reference measurement; however,

the measurement numeric values remain. Once the system reaches ambient temperature this

condition will cease to occur.

Toperformamanualzeroreferenceadjustment

Breath Rate Distortion

Theeffectofrisetimedistortiontothegascurvebecomesapparentwhenthebreathingrate

increasessothatthetimeforafullinspiratoryorexpiratoryeventgetsshorter.Inthose

situations,duetotheeffectoftherisetime,thegascurvedoesnotreachthetrueend‐tidal(or

firstinspiredvalue)andtheend‐tidalgasvaluemaythenbeunderestimated.Correspondingly,

thefirstinspiredvaluemaybeoverestimated.Belowisanexaggeratedillustrationoftheeffect.

Step Action

1 SelecttheCO2VSbox.

TheCO2menuappears.Currentsettingsaredisplayed.

2 SelectZeroCal.

Allowtheprocesstocomplete,typically10–12seconds.

9‐4MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse