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

Invivo Corporation Wireless SpO2 for Patient Monitoring in MRI Environments 989803193211

Manual

Expression MR400 MRI Patient Monitoring System
INSTRUCTIONS FOR USE
Revision A
English
*989803193211*
989803193211
ii
Manufacturer
Invivo,adivisionofPhilipsMedicalSystems
12151ResearchParkway
Orlando,FL32826,USA
8774684861
Email:
Info@invivocorp.com
Websites:
www.ExpressionMR.com
www.invivocorp.com
www.philips.com
Identification and Publication Details
PublishedbyInvivo,adivisionofPhilipsMedicalSystems.
Invivo,adivisionofPhilipsMedicalSystems,reservestherighttomakechangestoboththis
InstructionsforUseandtotheproductitdescribes.Productspecificationsaresubjecttochange
withoutnotice.NothingcontainedwithinthisInstructionsforUseisintendedasanyoffer,
warranty,promiseorcontractualcondition,andmustnotbetakenassuch.
©KoninklijkePhilipsN.V.(RoyalPhilips)2015
Allrightsreserved.Reproductioninwholeorinpartinanyformorbyanymeans,electrical,
mechanicalorotherwiseisprohibitedwithoutthewrittenconsentofthecopyrightholder.
REF989803193211Rev.A,March2015
Invivo,adivisionofPhilipsMedicalSystems
12151ResearchParkway
Orlando,FL32826
USA
Unauthorizedcopyingofthispublicationmaynotonlyinfringecopyright,butalsoreducethe
abilityofPhilipsMedicalSystemstoprovideaccurateanduptodateinformationtousers.
PublishedinUSA
iii
Regulatory
Compliance
TheExpressionMR400MRIPatientMonitoringSystemcomplieswithrelevantinternationaland
nationalstandardsandlaws.Informationoncompliancewillbesuppliedonrequestbyyourlocal
RoyalPhilipsrepresentative,orbythemanufacturer.
Explanation of Symbols
ThesymbolsinthefollowingtablemayappearontheExpressionMR400MRIPatientMonitoring
System,theaccessories,orthepackingmaterial.
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
iv
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
v
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
vi
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
ix
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
x
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
xi
Conventions
CertainconventionsareusedthroughouttheExpressionMR400MRIPatientMonitoringSystem
tospeeduseandfamiliaritywiththedevice.Thisaccompanyinguserinformationalsouses
documentconventionstoassistyouinfindingandunderstandinginformation.
System Conventions
Thefollowingsystemconventionsareused:
•Operationalcontrolisaccomplishedusingthetouchscreen,whereactiveelementsare
providedandtouchingthatelementwillactivate,openorexecutetherelatedmenu,
functionoritem.
•Mostmenusemployatimeoutfeaturewhere,ifnoactionistakenforapproximately30–
60seconds,anopenmenuwillautomaticallyclose.
•Toprotectagainstaccidentalchanges,adialogpromptisassociatedwithsomemenu
options.Whendisplayed,youmustanswerthisprompt;otherwise,adelayof
approximately30–60secondswillbeequivalenttoselectingNo(thiscanalsobe
accomplishedbypressingtheMainScreenkey.)
•Toprotectagainstunauthorizedchanges,somemenuitemsfeaturepasswordprotection.
Youmustenterthecorrectnumericcodeforaccessandadelayofapproximately30–60
secondsisequivalenttomakingnoentry.
Document Conventions
Thesedocumentconventionsareused:
Network channel 5 Network channel 10
Ten FlexTEMP System
Jackets per box
Symbol Symbol
xii
•Allproceduresarenumberedandanysubstepsarelettered.Completethestepsinthe
sequencepresentedtoensuresuccess.Proceduresareindicatedbythefollowingtable:
•Unlessnoted,allproceduresstartfromthenormalmodeofoperation.
• SelectmeanstopressonanactiveelementonthetouchscreenLCD(menuorsubmenu
item,button,key,vitalsignbox,etcetera).
•Bulletedlistsindicategeneralinformationaboutaparticularfeature,menufunctionor
procedure,anddonotimplysequentialorderoroperation.
•Controlnames,menuitems,vitalsignreferences,messages,etcetera,arespelledasthey
appearontheExpressionMR400MRIPatientMonitoringSystem.
•Menuitems,keynamesandmessagesareprovidedinboldfont.
•The“greaterthan”(>)symbolisusedwhennavigationofitemswithinamenuisindicated.
•ThefrontoftheExpressionMR400MRIPatientMonitoringSystemisnearestyouasyou
operateit;theleftandrightsidesarerespectivelytoyourleftandrightasyoustandin
frontofthesystem,facingit.
•Thefrontofawirelessmoduleisnearestyouasyouoperateit.Thetopofthedevice
pointsuporawaywhenthelabelingnearestyouduringoperationiscorrectlyorientedfor
reading,whiletheleftandrightsidesofthedevicearerespectivelytoyourleftandrightas
youholdthedeviceforoperation,facingit.
Step Action
1
2
3
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
ExpressionMR400InstructionsforUseImportantInformation11
CHAPTER 1
Important Information
About
AbouttheExpressionMR400MRIPatientMonitoringSystemandthisInstructionsforUse
ThisInstructionsforUseisintendedtoassistusersinthesafeandeffectiveoperationofthe
ExpressionMR400MRIPatientMonitoringSystem.
Beforeattemptingtooperatetheproduct,youmustreadthisInstructionsforUse,notingand
strictlyobservingallWARNINGSandCAUTIONnotices.
PayspecialattentiontoalltheinformationgivenandproceduresdescribedintheSAFETY
section.
AWARNINGalertsyoutoapotentialseriousoutcome,adverseeventorsafetyhazard.Failureto
observeawarningmayresultindeathorseriousinjurytotheuserorpatient.
ACAUTIONalertsyoutowherespecialcareisnecessaryforthesafeandeffectiveuseofthe
product.Failuretoobserveacautionmayresultinminorormoderatepersonalinjuryordamage
totheproductorotherproperty,andpossiblyinaremoteriskofmoreseriousinjury,and/or
causeenvironmentalpollution.
ANotehighlightsanunusualpointasanaidtoauser.
ThisInstructionsforUsedescribesthemostextensiveconfigurationoftheproduct,withthe
maximumnumberofoptionsandaccessories.Noteveryfunctiondescribedmaybeavailableon
yourproduct.
Thisproductwillperforminconformitywiththedescriptioncontainedinthismanualand
accompanyinglabelingwhenoperated,maintainedandrepairedinaccordancewiththe
instructionsprovided.
Thisdevicemustbecheckedandcalibratedperiodically.Amalfunctioningdevicemustnotbe
used.Partsthatarebroken,missing,plainlyworn,distorted,orcontaminatedmustbereplaced
immediately.Referthedevicetoqualifiedservicepersonnelforrepairorreplacement.This
deviceoranyofitspartsmustnotberepairedotherthaninaccordancewithwritteninstructions
providedbythemanufacturer.ThedeviceshallnotbealteredwithoutwrittenapprovalofRoyal
Philips.Theuserhasthesoleresponsibilityforanymalfunctionwhichresultsfromimproperuse,
faultymaintenance,improperrepair,damageoralterationbyanyoneotherthanauthorized
servicepersonnel.
12ImportantInformationExpressionMR400InstructionsforUse
Intended Use
ThisPhilipsproductisintendedtobeusedandoperatedonlyinaccordancewiththesafety
proceduresandoperatinginstructionsgiveninthisInstructionsforUseforthepurposesfor
whichitwasdesigned.Thepurposesforwhichtheproductisintendedisgivenbelow.However,
nothingstatedinthisInstructionsforUsereducesusers’responsibilitiesforsoundclinical
judgmentandbestclinicalprocedure.
TheExpressionMR400MRIPatientMonitoringSystemisintendedforusebyhealthcare
professionalstomonitorvitalsignsofpatientsundergoingMRIproceduresandtoprovidesignals
forthesynchronizationoftheMRIscanner.
Useandoperationofthisproductissubjecttothelawinthejurisdiction(s)inwhichtheproduct
isbeingused.Usersmustonlyinstall,useandoperatetheproductinsuchwaysasdonotconflict
withapplicablelaws,orregulations,whichhavetheforceoflaw.Usesoftheproductfor
purposesotherthanthoseintendedandexpresslystatedbythemanufacturer,aswellas
incorrectuseoroperation,mayrelievethemanufacturer(orhisagent)fromallorsome
responsibilityforresultantnoncompliance,damageorinjury.
CAUTION
Federal law restricts this device to sale by or on the order of a physician.
Compatibility
Theproductdescribedinthismanualshouldnotbeusedincombinationwithotherproductsor
componentsunlesssuchotherproductsorcomponentsareexpresslyrecognizedascompatible
byPhilipsMedicalSystems.[Alistofsuchproductsandcomponentsisavailablefromthe
manufacturer].Changesand/oradditionstotheproductshouldonlybecarriedoutbyPhilips
MedicalSystemsorbythirdpartiesexpresslyauthorizedbyPhilipsMedicalSystemstodoso.
Suchchangesand/oradditionsmustcomplywithallapplicablelawsandregulationsthathave
theforceoflawwithinthejurisdiction(s)concerned,andwithbestengineeringpractice.
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.
ExpressionMR400InstructionsforUseImportantInformation13
Indications for Use
TheExpressionMR400MRIPatientMonitoringSystemisintendedforusebyhealthcare
professionalstomonitorvitalsignsofpatientsundergoingMRIproceduresandtoprovidesignals
forsynchronizationfortheMRIscanner(alsoreferredtoas“triggering”or“gating”). The
ExpressionMR400providesmonitoringforthefollowingvitalsignsandparameters:
electrocardiogram(ECG),pulseoximetry(SpO2),noninvasivebloodpressure(NIBP);and
optionally,invasivebloodpressure(IBP),carbondioxide(CO2)andrespirationrate,anesthetic
agents,oxygen(O2),nitrousoxide(N2O),andtemperature.
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
ThisPhilipsproductshouldnotbeusedifanyofthefollowingcontraindicationsexistorare
thoughttoexist.Thisdeviceiscontraindicatedforpatientswithmetallicwires,implants,stents,
etcetera.Screenallpatientsformetallicwires,implants,stents,etceterapriortoMR
procedures.TheseelectricalconductorswillreactwiththeMRenvironmentorwiththe
accessory(ifapplieddirectlyovertheconductor),thusincreasingtheriskofheating.The
warningsbelowrefertotheExpressionMR400MRIPatientMonitoringSysteminitsentirety.
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.
14ImportantInformationExpressionMR400InstructionsforUse
Training
Usersofthisproductmusthavereceivedadequatetrainingonitssafeandeffectiveusebefore
attemptingtooperatetheproductdescribedinthisInstructionsforUse.Trainingrequirements
forthistypeofdevicewillvaryfromcountrytocountry.Usersmustmakesuretheyreceive
adequatetraininginaccordancewithlocallawsorregulations.Ifyourequirefurtherinformation
abouttrainingintheuseofthisproduct,pleasecontactyourlocalPhilipsMedicalSystems
representative.Alternatively,contactthemanufacturer.
ADEQUATETRAINING
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
BeforeusingtheExpressionMR400MRIPatientMonitoringSystem,readthesafetyinformation
below.ThewarningsbelowrefertotheExpressionMR400MRIPatientMonitoringSysteminits
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.
ExpressionMR400InstructionsforUseImportantInformation15
SAFETYAWARENESS
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.
SAFETYDEVICES
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.
INTENDEDUSEANDCOMPATIBILITY
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.
ELECTRICALSAFETY
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.
16ImportantInformationExpressionMR400InstructionsforUse
MECHANICALSAFETY
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.
FIRESAFETY
Useofanelectricalproductinanenvironmentforwhichitwasnotdesignedcanleadtofireor
explosion.Fireregulationsforthetypeofmedicalareabeingusedshouldbefullyapplied,
observedandenforced.Fireextinguishersshouldbeavailableforbothelectricalandnon
electricalfires.
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.
Ifitissafetodoso,attempttoisolatetheproductfromelectricalandothersuppliesbefore
attemptingtofightafire.Thiswillreducetheriskofelectricshocks.
ELECTROSTATICDISCHARGE
Electrostaticdischarge(ESD)canamounttoasignificantvoltage,whichmaycausedamageto
PCBsorothersystemcomponents.
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.
ConnectionstosensitivepartsareidentifiedbytheESDwarningsymbol(see
inset).ESDdamageiscumulativeandmaynotbeapparentatfirst,asindicated
byahardfailure,butcancausedegradedperformance.Therefore,alwaysuse
properESDhandlingprocedures.ESDcanresultfromlowhumidityconditions,
useofelectricalequipmentoncarpeting,linens,andclothing.
ExpressionMR400InstructionsforUseImportantInformation17
ELECTROMAGNETICCOMPATIBILITY(EMC)
ThisPhilipsproductcomplieswithrelevantinternationalandnationallawandstandardsonEMC
(electromagneticcompatibility)forthistypeofproductwhenusedasintended.Suchlawsand
standardsdefineboththepermissibleelectromagneticemissionlevelsfromproductandits
requiredimmunitytoelectromagneticinterferencefromexternalsources.
OtherelectronicproductsexceedingthelimitsdefinedinsuchEMCstandardscould,under
unusualcircumstances,affecttheoperationoftheproduct.
•MedicalelectricalproductsneedsspecialprecautionsregardingEMC,andneedstobe
installedandputintoserviceaccordingtoEMCinformationprovidedinthisInstructionsfor
Use.
•Theuseofaccessoriesandcablesotherthanthosespecified,mayresultinincreased
emissionordecreasedimmunitylevels.
•Theproductshouldnotbeusedadjacenttoorstackedwithotherproductsandthatif
adjacentorstackeduseisnecessary,itshouldbeobservedtoverifynormaloperation.
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.
18ImportantInformationExpressionMR400InstructionsforUse
Electromagnetic Compatibility (EMC)
Thedeviceisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Giventhe
device’selectromagneticemissionsandimmunitycharacteristics,thecustomerorusershould
assurethatthedeviceisusedwithinsuchanenvironment.Thefollowinginformationis
mandatedbyIEC6060112,theinternationalstandardfortheelectromagneticcompatibility
(EMC)ofmedicalelectricalequipment.
Radios
INDUSTRYCANADASTATEMENT
ThisdevicecomplieswithIndustryCanadalicenseexemptRSSstandard(s).Operationissubjectto
thefollowingtwoconditions:(1)thisdevicemaynotcauseinterference,and(2)thisdevicemust
acceptanyinterference,includinginterferencethatmaycauseundesiredoperationofthedevice.
LeprésentappareilestconformeauxCNRd'IndustrieCanadaapplicablesauxappareilsradio
exemptsdelicence.L'exploitationestautoriséeauxdeuxconditionssuivantes:(1)l'appareilne
doitpasproduiredebrouillage,et(2)l'utilisateurdel'appareildoitacceptertoutbrouillage
radioélectriquesubi,mêmesilebrouillageestsusceptibled'encompromettrelefonctionnement.
FCCCOMPLIANCESTATEMENT
CAUTION
Changes or modifications not expressly approved could void your authority to use this equipment
Thisdevicecomplieswithpart15oftheFCCRules.Operationissubjecttothefollowingtwo
conditions:(1)Thisdevicemaynotcauseharmfulinterference,and(2)thisdevicemustaccept
anyinterferencereceived,includinginterferencethatmaycauseundesiredoperation.
FrequencyRange:2402–2482MHz
ModulationType:GFSK
WPUEIRP:4.2dBm(peak)
wECGandwSpO2EIRP:0dBm(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.
ExpressionMR400InstructionsforUseImportantInformation19
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
110ImportantInformationExpressionMR400InstructionsforUse
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.
ExpressionMR400InstructionsforUseImportantInformation111
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.
P
P
P
112ImportantInformationExpressionMR400InstructionsforUse
Using Batteries Safely
Batterieshavelifecycles.Thebatterylifeisatanendwhentheequipmentoperatingtime
providedbybatterypowerbecomesmuchshorterthanusual(i.e.,whenthetotalbattery
capacityhasonly70percentitsinitialcapacity).Foroptimalbatterylife,pleasefollowthese
guidelines:
•Donotstorethebatteriesinadischargedcondition.Alwayschargeabatterytoatleast40
percentofcapacitybeforestoring.
•Chargethebatteriesonceamonthwhennotinuse.
Immediatelyremoveanybatterythathasanexpiredlifecycleandreplaceitwithanewbattery
ofthesametype.(Refertopage137forpartnumbers.)Toensurethesafetyofoperatorsand
patients,observethefollowingwarningsandcautions.
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.
P
P
P
ExpressionMR400InstructionsforUseImportantInformation113
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
Toreportshippingdamage,ortoresolveanyissuesorconcernswithyourorder,contact
CustomerService.(Saveallpackingmaterialsandrelatedshippingdocuments,asthesemaybe
requiredtoprocessashippingdamageclaimwiththecarrier.)
Afterremovingthecontentsfromtheshippingcontainers,carefullyexamineallitemsforsignsof
damagethatmayhaveoccurredduringshipment.Also,checkallitemsagainsttheincluded
packinglistandthepurchaserequest.
Thecontentsofthecrateshouldinclude:
• ExpressionMR400MRIPatientMonitoringSystem
•Twomainbatteries
InstructionsforUse(IFU)manual
•QuickReferenceGuide(includedinEnglishlocalizedshipmentsonly)
•PowerCord
Aseparatecontainermayincludeadditionalitems:
• WirelessECGpatientmodule(Gen3)
• WirelessSpO2patientmodule(Gen3)
114ImportantInformationExpressionMR400InstructionsforUse
•Modulebatterycharger
•Modulebatteries
Disposing of the Packaging
Thepackagingcanberetainedforfutureuse.Otherwise,thepackagingforthesystem(whichis
madeofrecyclablematerialsthatincludecorrugatedpaper,polyethylene[PE]foamandplastic)
maybesubjecttodisposalregulationsforuserandenvironmentalsafety.Fordisposal,itmaybe
necessarytoseparatethesematerialsbytype.Alwaysobserveandadheretoyourcurrentlocal
regulationswhendisposingofthepackagingmaterial.
Initial Setup
TheinstructionsbelowdetailtheinitialsetupprocessforafullyequippedExpressionMR400MRI
PatientMonitoringSystem(hereafterreferredtoastheMR400)—includingthewirelessECG
patientmodule(hereafterreferredtoasthewECGmodule)andthewirelessSpO2patient
module(hereafterreferredtoasthewSpO2module)andhereafterreferredtocollectivelyas
wirelessmodules.
DependingupontheneedsofyourfacilityandtheMR400optionspurchased,thestepsyou
followmaydifferandsomemaynotberequired.Forthelocationofcomponentsnotdetailed
below,seechapter2.
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.
ExpressionMR400InstructionsforUseImportantInformation115
ToperforminitialsetupoftheMR400
Step Action
1PerformavisualinspectionoftheMR400,checkingforlooseor
missinghardwareordamage.
Iflooseormissinghardwareordamageisobserved,contact
technicalsupport.
2Installthemainbatteriesintothecartandconnectthereserve
batteries;seepage116.
3ConnectACmainspowertotheMR400,butDONOTturnonthe
powerswitch.Allowthebatteriestochargeforatleast12hours
beforeuse;seepage120.
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.
4IfwECGandwSpO2moduleswereincluded,performavisual
inspectionofthedevicesforlooseormissinghardwareordamage.
5IfawSpO2modulewasincluded,attachanSPO2probetoit;see
page118.
6Ifmodulebatterieswereincluded,chargethemodulebatteries
usingthePhilipsspecifiedbatterycharger.(Refertothe
instructionsprovidedwiththecharger.)
Note
Before initial use, charge the module batteries for at least 4 hours.
7Pressthepowerswitch(onthefrontofthecart)thenverifythatthe
MR400hassuccessfullypoweredupandthatthepowerLEDis
steadygreen.
Forotherpossibleindications,seepage27.
8IfequippedwithanIP5,verifythattheMR400andIP5aresettothe
samewirelessnetworkchannelbycheckingthenetworkicon(see
examplesbelow)thatisdisplayedbyeachdevice.
Seepage127forMR400networksettinginstructions;and,referto
theIFUfortheIP5fornetworksettinginstructions.
9IfwECGandwSpO2moduleswereincluded,installthecharged
modulebattery(orbatteries)intothedevice(s);seepage124for
thewECGmoduleandseepage126forwSpO2module.
116ImportantInformationExpressionMR400InstructionsforUse
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.
FourbatteriesareusedintheMR400:
•Twomainbatteriesmustbeinserted—oneintotheleftbatterycompartmentandoneinto
therightbatterycompartmentofthecart;and,
•Tworeservebatteries,internallyhousedinthecart,mustbeswitchedon.
Toinstallandconnectthemainandreservebatteries
10 VerifythatthestatusindicatoronthewECGandwSpO2modulesis
illuminatedsteadygreen:
•ForthewECGmodule,seepage29.
•ForthewSpO2module,seepage211.
11 VerifythatthewirelessnetworkchannelsonthewECGandwSpO2
modulesaresettothechannelusedbytheMR400;seepage129.
12 PlacethewECGandwSpO2modulesintothemoduleholderson
theMR400;seepage212.
Thiscompletestheinitialsetupprocess.Forinformationregarding
otherpossibleMR400connections;seeRearPanelConnectionson
page119.
Step Action
Step Action
1Locatethebatterycompartments,whichareunderneaththeWPU
ontheleftandrightsidesofthecart.
ExpressionMR400InstructionsforUseImportantInformation117
2Holdamaincartbatterywiththelabelsidedownandwithits
connectorfacingforward.(Silkscreeningaboveeachbattery
compartmentprovidesthecorrectbatteryorientation—theleft
sideisshownintheexamplebelow.)Then,slidethebattery
completelyintothebatterycompartmentuntila“clickisheardas
thebatterylatchesintoplace.
(Ifthebatterydoesnotlatchintoplacewheninserted,thenitis
notproperlyoriented.Inthiscase,remove,reorientcorrectly,and
thenreinsertthebattery.)
3Repeatsteps1and2toinstalltheremainingmaincartbatteryon
theoppositesideofthecart.
4 Removetheshieldcapfromthegatingconnectorandthetwo
screwsthatsecuretheservicepanelcovertothebackoftheWPU
thenremovetheservicepanelcover.
Step Action
Main cart battery
Battery compartment
WPU
Screws
Service panel
cover
Shield cap
118ImportantInformationExpressionMR400InstructionsforUse
Attaching the SpO2 Probe to the wSpO2 Module
TheSpO2probe,necessaryfortakingSpO2relatedmeasurementsusingthewSpO2module,
mustbeconnectedprioruse.
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.
ToattachtheSPO2probe
InserttheSPO2probeconnectorintotheDB9connectoronthewSpO2
modulethensecurelytightenbothscrews.
5LocatethebatteryswitchandtoggleitintotheOn(I)position.
6 Reinstalltheservicepanelcover,andsecureittotheWPUusing
thetwoscrews.
7Replacetheshieldcap.
Thiscompletestheinstallationandconnectionofthemainand
reservebatteries.ConnectACmainspowerthenallowthese
batteriestochargeforatleast12hoursbeforeinitialuse;seepage
121.
Step Action
Battery switch
1wSpO2 module
2DB-9 connector
3SPO2 probe connector
4Screws
3
4
2
1
ExpressionMR400InstructionsforUseImportantInformation119
Rear Panel Connections
DependingupontheoptionsincludedwithyourMR400ortheusemodel,someconnectionsmay
berequiredaftermovingtheMR400intotheMRmagnetroom.Inadditiontotheconnectionfor
ACmainspower,connectionsforthewastegasportandthegatingcableareavailableonthe
rearpaneloftheMR400.(ForinformationabouttheplacementoftheMR400intheMRmagnet
room,seepage32.)
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.
Wheretheintegrityoftheexternalprotectiveconductorintheinstallationoritsarrangementis
indoubt,theMR400shallbeoperatedfrombatteries.
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
2
3
4
5
120ImportantInformationExpressionMR400InstructionsforUse
Connecting AC Mains Power
WhenconnectingtheMR400tothemainselectricalsupply,donotroutethedetachablepower
cordwhereitwillbeanobstructionorsteppedupon.DonotblockaccesstotheMR400with
otherequipmentandneverpositiontheMR400insuchawaythatwouldmakeitdifficultto
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.
ToconnectACmainspower
ToremovetheMR400fromACmainspower
PulltheplugofpowercordfromtheACwalloutlet.Then,liftthestrainreliefandremovethe
powercordfromtheACreceptacleontherearoftheMR400.Storethecordinasafeplace.
4Strain relief for retention of the power cord.
5AC receptacle for connection of the power cord.
Step Action
1Ensurethatallcartbatteriesareinstalledandswitchedon;see
page116fordetails.
2IfplacingtheMR400intheMRmagnetroom,positiontheMR400
ataproperlocation;seepage32.
3Raisethestrainrelief;seepage120forthelocation.
4PlugthepowercordintotheACreceptacleontheMR400;see
page120forthelocation.
Foraddedmobility,thepowercordextension(REF989803168221)
canalsobeconnected.
5Lowerthestrainreliefoverthepowercord.
6PlugthepowercordintoanapprovedACmainsoutlet.
ExpressionMR400InstructionsforUseImportantInformation121
Understanding Battery Operations
Cart Batteries
Warning
WARNING
Do not touch the patient and the circuitry in the battery compartments of the MR400
simultaneously.
Cartbatteries,wheninstalled(main)andswitchedon(reserve),arechargedandconditionedby
anintegratedchargingsystem.WhenturnedonandconnectedtoACmains,theMR400operates
fromACpowerandsimultaneouslychargesallcartbatteries.Whenturnedoffandconnectedto
ACmains,batterychargingfunctionscontinue.
Ifatanytime,ACmainsislost,theMR400willautomaticallyswitchtobatterypowertoprovide
uninterruptedservice—then,whenACmainsisrestored,theMR400willautomatically,without
delay,revertbacktoACpowerfunctions.IfthereservebatteriesarefullydepletedandACmains
islost,thentheunitwillpoweroff.
TheMR400’smaximumoperatingtimeonbatterypowerdependsupontheenabledparameters
andthetypeandfrequencyofmonitoringfunctions(seetheBattery,OperationTimeonpageA4
foralisting).
Charging Cart Batteries
Cartbatteriesmustbechargedbeforeinitialuse.Duringinitialsetuporwheninstallingnew
batteries,chargethecartbatteriesforatleast12hourssothattheyarefullychargedand
conditionedforoperation.
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.
122ImportantInformationExpressionMR400InstructionsforUse
Tochargethecartbatteries
Chargedcapacityofallcartbatteriescanbedisplayed;seetheStatusInformationPanelonpage
218).
Chargedcapacitycanalsobefoundbypressingthepowerlevel
buttononeachmaincartbattery,wherethecurrentlevelis
providedbythechargeindicator;seeRemovingCartBatteries,
below.
Removing Cart Batteries
Toremovethemainbatteries
Step Action
1Ensurethatallcartbatteriesareinstalledandswitchedon.
SeeInstallingandConnectingCartBatteriesonpage116for
details.
2ConnecttheMR400toACmainspower.
SeeConnectingACMainsPoweronpage120.
3EnsurethattheMR400isturnedoffandthatitremainsoffforthe
next12hours.
1Charge indicator
2Power level button
3Cart battery
12
3
Step Action
1Locatethebatteryejectbutton,whichisinarecessedareaunder
eachbatterycompartmentontheleftandrightsidesofthecart.
ExpressionMR400InstructionsforUseImportantInformation123
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
ModulebatteriesprovidepowertothewECGandwSpO2modules.Modulebatteriesare
interchangeable,nonmagnetic,andcanbehandledsafelyintheMRmagnetroom.
CAUTION
To minimize the chance of image artifacts, never place module batteries in the MRI field of view.
2Pressthebatteryejectbuttontopartiallyejectamainbatteryfrom
thebatterycompartment,andthengraspthebatteryandpullto
removeitcompletelyfromtheMR400.
(Ifthebatterydoesnotrelease,applyaslightforwardpressureto
thebatterywhilepressingthebatteryejectbutton.)
3Repeatsteps1and2toremovetheothermaincartbatteryonthe
oppositesideoftheMR400.
Main battery
Battery compartment
Battery eject button
124ImportantInformationExpressionMR400InstructionsforUse
Charging Module Batteries
Modulebatteriesmustbechargedforatleast4hoursbeforeinitialuse.Modulebatteriesare
chargedinthePhilipsspecifiedbatterycharger.Refertotheinstructionsprovidedwiththis
batterychargerforinformation.
Installing Batteries in the wECG Module
ThewECGmodulecanacceptuptotwobatteries.Dependinguponthenumberofbatteries
installed,thewECGmoduleprovidedifferentoperationalfeatures:
•Ifonebatteryisinstalled,thenthewECGmodulewillturnonandfunctionnormally—but
beforeitschargeisexhausted,asecondbatterymustbeinstalledinordertocontinuethe
ECGstudy.
•Iftwobatteriesareinstalled,thenseamlessoperationispossible—onebatterywillprovide
poweruntilitschargeisexhausted,atwhichtimethewECGmodulewillautomatically
switchtotheremainingbatteryforcontinuedoperation.Aslongassufficientpoweris
providedbythesecondbattery,continuedoperationispossible.And,anexhausted
batterycanbereplacedatanytimewithoutinterruptiontotheECGstudy,providedthat
sufficientchargeispresentontheremainingbattery.
•IndicatorsidentifythesourcebatterybeingusedbythewECGmodule;seepage29.
•Whenbothbatteriesareremoved,thewECGmodulewillturnoff.
ToinstallbatteriesinthewECGmodule
Step Action
1HoldthewECGmodulesothatitsbatterybaysareorientedas
shown,withbatterybay1inthelowerpositionandbatterybay2
intheupperposition.
wECG module
Bay 1
Bay 2
ExpressionMR400InstructionsforUseImportantInformation125
Removing Batteries from the wECG Module
Toremovebattery1fromthewECGmodule
Pressabatteryejectbutton1(item1,right).Then
graspthepartiallyejectedmodulebattery(item2)
andpulltoremoveit.
2Orientamodulebatterysothatthetipofthebatteryarrowaligns
withthetipofthebay1arrowonthewECGmodule.Thenslidethe
modulebatteryintobay1,pressinguntilitseatscompletely.
3Orientamodulebatterysothatthetipofthebatteryarrowaligns
withthetipofthebay2arrowonthewECGmodule.Thenslidethe
modulebatteryintobay2,pressinguntilitseatscompletely.
Step Action
Module battery
Bay 1 arrow
Battery arrow
Module battery
Bay 2 arrow
Battery arrow
1
2
126ImportantInformationExpressionMR400InstructionsforUse
Toremovebattery2fromthewECGmodule
Pressabatteryejectbutton2(item3,right).Then
graspthepartiallyejectedmodulebattery(item4)
andpulltoremoveit.
Installing a Battery in the wSpO2 Module
ThewSpO2moduleusesonebattery.Whenamodulebatteryisinserted,thewSpO2modulewill
turnon.And,whenthebatteryisremoved,thewSpO2modulewillturnoff.
ToinstallabatteryinthewSpO2module
3
4
Step Action
1HoldthewSpO2modulesothatitsbatterybayisorientedas
shown.
2Orientamodulebatterysothatthetipofthebatteryarrowaligns
withthetipofthebayarrowonthewSpO2module.Thenslidethe
modulebatteryintothebatterybay,pressinguntilitseats
completely.
wSpO2 module
Battery bay
Module battery
Bay arrow
Battery arrow
ExpressionMR400InstructionsforUseImportantInformation127
Removing the Battery from the wSpO2 Module
ToremovethebatteryfromthewSpO2module
Pressthebatteryejectbutton(item1,right).Then
graspthepartiallyejectedmodulebattery(item2)
andpulltoremoveit.
Understanding Wireless Network Operations
AwirelessnetworkchannelisusedforsystemcommunicationbetweentheMR400cartandthe
wECGandwSpO2modules(and,ifequipped,theIP5).Allwirelessdevicesmustusethesame
wirelessnetworkchannelforpropersystemcommunications.Also,wheremultipleInvivo(Royal
Philips)MRIpatientmonitoringsystemsareinuse,theselectedwirelessnetworkchannelshould
benotusedbyanyothersysteminyourfacility(forthefrequencyrange,seepage18).
Setting the Wireless Network Channel of the Cart
AllcontrolsforselectingthewirelessnetworkchanneloftheMR400arelocatedonthecarts
touchscreen.Uniquesymbolsandnumbersareusedtoidentifyeachavailablechannelforthe
MR400,asshownbelow.
2
1
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
128ImportantInformationExpressionMR400InstructionsforUse
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.
TosetthewirelessnetworkchannelfortheMR400cart
Step Action
1Pressthepowerswitch(seepage27forthelocation)thenallow
theMR400toinitialize.
Themainscreenappears.
2 Selectthenetworkicon.
Thenetworkmenuappears.
Network icon
Network menu
ExpressionMR400InstructionsforUseImportantInformation129
Setting the Wireless Network Channel of the wECG and wSpO2 Modules
Allindicatorsandcontrolsforwirelessnetworkchannelselectionarelocatedonthefrontofthe
wirelessmodules.Twodifferentgroupsoffivewirelessnetworkchannelsareavailable(channels
1–5,orchannels6–10)andbothmodulesmustbeofthesamegroup,dependinguponyour
selectionattimeofpurchase.
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.
Thewirelessnetworkchannelforamoduleischangedbyusingthe
networkselectionbutton.Thewirelessnetworkchannelfora
moduleshouldbesettomatchthewirelessnetworkchannelused
bytheMR400;seepage127.
Thefollowingdirectionsforchangingthewirelessnetworkchannel
applytobothwirelessmodulesandtoeitherchannelgroup,though
theprocessbelowdepictsthewSpO2moduleandchannelgroup1–
5.(FormoreoperationaldetailsaboutthewECGmodule,seepage
29;and,forthewSpO2module,seepage211.)
3 Selectthedesiredsettingfromtheoptions:
1
2
3
4
5
6
7
8
9
10
Thesettingisenteredandthenetworkiconischangedtothe
currentselection.
4EnsurethatthenetworkchannelusedbythewECGandwSpO2
modules(seepage129)andtheIP5(ifequipped)areidenticalto
thenetworksettingofthecart.
Step Action
1Network channel indicators
2Network selection button
2
1
130ImportantInformationExpressionMR400InstructionsforUse
Beforestartingtheproceduretochangethenetworkchannelofthewirelessmodule,takenoteof
theseconventionsthatareusedtoexplaintheprocess:
•Thefollowingsymbolsareusedtoconveythestateofthenetworkchannelindicatorona
wirelessmodule.
•Thefollowingillustrationsareusedtoconveyactionsconcerningtheuseofthenetwork
selectionbutton.
TosetthewirelessnetworkchannelofthewECGorwSpO2module
Symbolilluminated Symbolblinking
Pressingthe
button
Pressingandholding
thebutton
Releasingthe
button
Repeating
Step Action
1Turnoffthewirelessmodule:
•wECGmodule—seeRemovingBatteriesfromthewECG
Moduleonpage125.
•wSpO2module—seeRemovingtheBatteryfromthewSpO2
Moduleonpage127.
2Turnonthewirelessmodule:
•wECGmodule—seeInstallingBatteriesinthewECGModule
onpage124.
•wSpO2module—seeInstallingaBatteryinthewSpO2
Moduleonpage126.
Thenetworkchannelindicatorswillflashbrieflyandthenthe
currentnetworkchannelindicatorwillilluminate(forexample,“3”
intheillustrationbelow).
ExpressionMR400InstructionsforUseImportantInformation131
3 Enterthenetworkchannelchangemode:Afterthecurrent
networkchannelindicatorhasbeenilluminated(andwithin10
secondsofmodulepowerup),pressandholdthenetwork
selectionbuttonuntilthecurrentnetworkchannelindicatorbegins
torapidlyblinkthenreleasethebutton.
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.
4Pressdownagainonthenetworkselectionbuttonuntilthesymbol
stopsblinkingandthenreleasethebuttontochangethenetwork
channelsetting.
Whenyoudothis,thenextnetworkchannelindicatorinthe
sequencewillblinkrapidly.(Inotherwords,ifthemodulewas
originallyusingnetworkchannel“3,”nowthe“4”symbolwillbe
blinking.)Repeatthissequenceofpressingdownandreleasingthe
buttonuntilthesymbolofthenetworkchannelyoupreferis
rapidlyblinking.Ifyoupassthedesiredchannel,simplycontinue
pressingandreleasingthebuttonuntilthedesirednetwork
channelindicatorisblinkingagain.
Step Action
132ImportantInformationExpressionMR400InstructionsforUse
5Whenyoureachthedesiredsymbol,pressandholdthebuttonfor
approximately5secondstolockandsavethenewsetting.
Theselectednetworkchannel'ssymbolwillturnoffwhilethe
buttonisdepressed.Thenitwillilluminate(notblink)whenthe
newnetworkchannelsettingissaved.Onceilluminated,release
thebutton.Themodulewillbeginusingtheselectednetwork
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
ExpressionMR400InstructionsforUseImportantInformation133
Advanced User Options
Expression Information Portal (Model IP5)
ProvidingsystemcontroloutsidetheMRmagnetroom,the
ExpressionInformationPortal(ModelIP5),hereafterreferred
toastheIP5,isawirelessdevicethatalsofeaturesprinting
capabilitiesandHL7dataoutputoptions.
TheMR400usesawirelessconnectionforcommunication
withtheIP5.TheIP5’sconnectiontothehospitalinformation
system(HIS)isexplainedindetailintheIP5IFU.Whenusing
theIP5toconnecttotheHIS,adheretoallcautionsandsafety
instructionsfoundintheIP5IFU.
Additional Options
Additionaloptionsmaybesuggestedbyyourbiomedicaltechniciantoincreaseuserease.
Consultyourbiomedicaltechnicianortechnicalsupportwithspecificrequests.
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
Accessoriesarelistedinthetablesbelowwithpartnumber(REF)information.Whereapplicable,
theoriginalpartnumberhasalsobeenincludedforreference.Foradditionalinformationabout
theseaccessories,pleaseconsultthedocumentationthataccompaniestheaccessory.
134ImportantInformationExpressionMR400InstructionsforUse
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
ExpressionMR400InstructionsforUseImportantInformation135
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
136ImportantInformationExpressionMR400InstructionsforUse
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
ExpressionMR400InstructionsforUseImportantInformation137
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
138ImportantInformationExpressionMR400InstructionsforUse
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
ExpressionMR400InstructionsforUseImportantInformation139
MANUAL, OPERATOR, MR400, TRAD. CHINESE 989803193351
MANUAL, OPERATOR, MR400, TURKISH 989803193361
Miscellaneous REF
140ImportantInformationExpressionMR400InstructionsforUse
ExpressionMR400InstructionsforUseSystemOverview21
CHAPTER 2
System Overview
TheMR400isdesignedtoprovidemultivitalsignpatientmonitoringandMRIgatingcapabilityin
theMRIenvironmentwhileincloseproximitytoanMRIscannermagnet.Themonitoring
capabilitiesoftheMR400canbeconfiguredtomeettheneedsofawidespectrumofpatients
fromneonatetoadult.Everyparametercanbeaccessedandadjustedfortheuniqueconditionof
eachpatient.TheMR400accommodatesspecificmonitoringneeds,including:
•Adult,pediatricandneonatalpatients
•Criticallyillpatients
•Patientundergoingsedation
•PatienttransportwithintheMRenvironment
• Interventionalprocedures
•Cardiacgating
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
TheMR400simultaneouslyprocessesanddisplaysmultipleparameters,waveforms,
measurementnumericvaluesandalarms.Allpatientinformationisprovidedonthetouch
screen.AfullyequippedMR400includesmonitoringforthefollowingparameters:
• Electrocardiogram(ECG),dualchannel
•Heartrate(HR)
•Bloodoxygensaturation/pulseoximetry(SPO2)
•EndtidalandfractionalinspiredCO2(EtCO2andFiCO2)
•Invasivebloodpressure(P1andP2)
•Anestheticagents(AGENT)
•FractionalinspiredO2(FiO2),andendtidalandfractionalinspiredN2O(EtN2OandFiN2O)
• Temperature(TEMP)
22SystemOverviewExpressionMR400InstructionsforUse
•Noninvasivebloodpressure(NIBP)
• Respirationrate(CO2orbellows)
Note
Depending upon the equipped options, your MR400 may not have all indicated parameters.
System Components
Beforeuse,familiarizeyourselfwiththeMR400anditscomponents.AcompleteMR400system
consistsofthefollowingcomponents:
• MR400cart
•wECGmodule
•wSpO2module
•Modulebatterycharger
• Batteriesandotheraccessoriesasneeded
•Optional:IP5withorwithoutaprinter
Use Model
TheMR400isintendedtobeusedtomonitorthevitalsignsofapatientinanMRmagnetroom,
asillustratedbelow.ThewECGandwSpO2modulescommunicateviawirelesslinkstosupplythe
patientsmeasuredECG,SPO2,andbellowsderivedrespirationsignalstotheMR400.Thegating
cableisonlyrequiredforMRItriggeringandsynchronizationbasedonthepatient’sECGorSPO2
signals.WhenpairedwithanoptionalIP5,monitoringcapabilitycanbeextendedviawirelesslink
toanMRcontrolroom,inductionroom,orrecoveryroomenvironment.Datatransmittedfrom
theMR400toanIP5canbeoutputtoanoptionalstripchartprinterortothehospitalinformation
system(HIS).
ExpressionMR400InstructionsforUseSystemOverview23
Acquisition and Control
UseoftheMR400isrestrictedtoonepatientatatime.TheMR400displayspatient
measurementsacquiredduringmonitoring.Controlsandsettingsforpatientmonitoringare
providedlocallyonthetouchscreenorremotely(forexample,intheMRIcontrolroom)when
equippedwiththeIP5,whereconnectionsfortheprinterandthehospitalnetworkarealso
available.
Synchronization
TheMR400willautomaticallyestablishcommunicationwiththewirelessmodules,andIP5(if
equipped).However,duetotheusemodel,thedevicescanestablishcommunicationand
synchronizepoweronsettingsaccordingtothestartupsequence:
•IftheMR400bootsandcommunicatesfirst,thenitssettingswillbereflectedattheIP5.
•IfanIP5bootsandcommunicatesfirst,thenitssettingswillbereflectedattheMR400.
IfusinganIP5,patientidentifiableinformation(nameandIDnumber)willbeavailableafter
synchronizationoccurs.
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
24SystemOverviewExpressionMR400InstructionsforUse
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
Menucommandsthatcontrolparameterfunctionsforpatientmonitoringaresynchronized
betweentheMR400andIP5.Commandsthatdonotdirectlycontrolpatientparameters(for
example,printerfunctions)willonlyaffecttheIP5.Othercontrolsettingsremainlocalizedtothe
IP5andarenotsynchronizedwiththeMR400,includingthealarmaudiooffandalarmaudio
pausefunctions,andthevolumesettings;seetheIP5IFUforacompletelisting.
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.
ExpressionMR400InstructionsforUseSystemOverview25
Hardware Features
Cart
DesignedforuseintheMRmagnetroomandthroughouttheMRsuite,theMR400isaself
containedmobilepatientmonitoringsystem.TheMR400featuresawheeledcartdesignwith
fourlargelockablecastersunderitsaluminumframeandincludesintegratedsystemsfor
processing,power,displayandcontrol,asoutlinedbelow.
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.
1
2
3
4
5
5
9
66
7
8
4
10
2
26SystemOverviewExpressionMR400InstructionsforUse
Display Panel
ThedisplaypanelincludesatouchscreenLCD(liquidcrystaldisplay),thealarmindicatorsandan
audiospeaker.Thedisplaypanelcanbetiltedbackwardorforwardtoachievethebestviewing
angleandreduceanyglareonthetouchscreenproducedbyambientlighting.
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.
1
2
3
4
ExpressionMR400InstructionsforUseSystemOverview27
Patient Connection Panel
ThepatientconnectionpanelcontainsthepowerswitchandLED,andinputconnectionsfor
variouspatientaccessories.
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
On
8
7
4
3
2
1
6
5
28SystemOverviewExpressionMR400InstructionsforUse
wECG and wSpO2 Modules
ThewECGandwSpO2modulesarebatterypoweredandcommunicatewiththeMR400through
abidirectional2.4GHzRFlink,whichisautomaticallyestablishedapproximately30secondsafter
powerisappliedtothemodule.Thesewirelessmodulesoperateatadistanceofupto9.1m(30
feet)fromtheMR400cartwhenalldevicesareplacedwithinthesameMRIroomorwithinthe
sameshieldedroom.
Thenetworkchannelandbatteryindicatorsdenotetheselectednetworkchannelandthe
batterystatusforeachwirelessmodule.Aftercommunicationshavebeenestablished,all
moduledependentvitalsigninformationwillbedisplayedwithin10secondsontheMR400.
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
ExpressionMR400InstructionsforUseSystemOverview29
wECG Module
ThewECGmoduletransmitsmeasuredECGsignalsthroughtheRF
linktotheMR400,wheretwoECGsignalscanbedisplayedandare
availableforinterfacingwiththeMRsystemcardiacgatinginput.
ThemodulealsoreceivesinformationfromtheMR400toperform
commandedtasks(forexample,leadviewandfiltermode
selections).
wECG Module Indicators
BatteryindicatorsprovidechargestatusindicationsforeachbatteryusedbythewECGmodule,
asdetailedinthetablebelow.
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
4
1
5
6
7
8
23
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
210SystemOverviewExpressionMR400InstructionsforUse
Networkchannelindicatorilluminatestoprovidethewirelessnetworkchannelindicationand
thestatusofthewECGmoduletoMR400communications,asdetailedinthetablebelow.
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
ExpressionMR400InstructionsforUseSystemOverview211
wSpO2 Module
ThewSpO2moduletransmitsmeasuredbloodoxygensaturation,
plethysmography,peripheralpulsedataandpneumaticrespiration
ratevaluesthroughtheRFlinktotheMR400,wheretheprocessed
informationcanbedisplayedandoutputforinterfacingtotheMR
systempulseperipheralandrespirationgatinginput.
wSpO2 Module Indicators
BatteryindicatorprovideschargestatusindicationsforthewSpO2module,asdetailedinthe
tablebelow.
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.
Networkchannelindicatorilluminatestoprovidethewirelessnetworkchannelselection
indicationandthestatusofthewSpO2moduletoMR400communications,asdetailedinthe
tablebelow.
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
3
1
5
4
7
6
2
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
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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
ExpressionMR400InstructionsforUseSystemOverview213
TostorethewECGmoduleandaconnectedECGleadcable
LooptheECGcabletrunkwithfoaminsulatorandsecureitusingthe
Velcrostoragestrap(seepage52).Then,placethewECGmodule
intoamoduleholderandallowtheECGleadcabletodrape.
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.
TostorethewSpO2moduleandaconnectedprobe
PlacethewSpO2moduleintoamoduleholderandallowtheSPO2
probetodrape.
Tostoresmallaccessories,samplelinesandthetemperaturesensor
•Usetheremovablestoragebaskettoholdsmallaccessories(Quadtrodes,SPO2clipsand
grips,etcetera).Toremovethestoragebasketfromthecart,graspthebasketandlift.
•Usetheaccessoryhookstohangloopedsamplelines,thetemperaturesensor,etcetera.
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
ThedisplayedinformationandcontrolsfortheMR400aregroupedonthetouchscreen
accordingtofunction.
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.
214SystemOverviewExpressionMR400InstructionsforUse
Information Bar
Theinformationbarprovidesgeneraluse,vitalsigndetectionandpatientinformation.
1Information bar
2Soft keypad
3Status information pane
4Vital sign boxes
5Vital sign traces
4
3
2
1
5
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
5
ExpressionMR400InstructionsforUseSystemOverview215
Soft Keypad
Thesoftkeypadprovidesimmediateaccesstofrequentlyusedmenusandfunctions.
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
1
2
3
4
5
6
7
8
9
10
11
12
13
216SystemOverviewExpressionMR400InstructionsforUse
Status Information Pane
ThestatusinformationpaneprovidesindicationsfortheMR400andwirelessdevices:
• Communicationandpowerindicationswillbedisplayedwithin2seconds.
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.
1
2
3
4
5
ExpressionMR400InstructionsforUseSystemOverview217
Powersourcechangeofstateindicationsaredisplayed.
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.
1
2
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• Indicationsareprovidedforalossofcommunication,whichisindicatedwithin2seconds,
andanodatacondition(seepage220)willbedisplayedwithin10secondsforallvitalsign
informationmissingduetoanoncommunicatingwirelessmodule.
Status Information Panel
Thestatusinformationpanelprovideswirelesscommunicationandpowerdetails,