Invivo 2GMODSB WIRELESS ECG MODULE User Manual 989803184961

Expression MR200 MRI Patient Monitoring System

INSTRUCTIONS FOR USE

Revision B

English

*989803184961*

989803184961

ii

Manufacturer

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

12151ResearchParkway

Orlando,FL32826

USA

877‐468‐4861

+31(0)499378299

www.invivocorp.com

Copyright

Copyright©2013,KoninklijkePhilipsN.V.

Allrightsreserved.

REF989803184961Rev.B,October2013

PrintedinUSA

Proprietary Information

Thisdocumentandtheinformationcontainedinitisproprietaryandconfidential

informationofKoninklijkePhilipsN.V. andmaynotbereproduced,copiedinwholeorin

part,adapted,modified,disclosedtoothers,ordisseminatedwithoutthepriorwritten

permissionoftheKoninklijkePhilipsN.V.Thisdocumentisintendedtobeusedbycustomers

andislicensedtothemaspartoftheirKoninklijkePhilipsN.V. equipmentpurchase.Useof

thisdocumentbyunauthorizedpersonsisstrictlyprohibited.

KoninklijkePhilipsN.V. providesthisdocumentwithoutwarrantyofanykind,impliedor

expressed,including,butnotlimitedto,theimpliedwarrantiesofmerchantabilityand

fitnessforaparticularpurpose.

KoninklijkePhilipsN.V. hastakencaretoensuretheaccuracyofthisdocument.However,

KoninklijkePhilipsN.V. assumesnoliabilityforerrorsoromissionsandreservestherightto

makechangeswithoutfurthernoticetoanyproductshereintoimprovereliability,function,

ordesign.KoninklijkePhilipsN.V. maymakeimprovementsorchangesintheproductsor

programsdescribedinthisdocumentatanytime.

Neweditionsofthisdocumentwillincorporateallmaterialupdatedsincetheprevious

edition.Updatepackagesmaybeissuedbetweeneditionsandcontainreplacementand

additionalpagestobemergedbyarevisiondateatthebottomofthepage.Notethatpages

whicharerearrangedduetochangesonapreviouspagearenotconsideredrevised.

Thedocumentationpartnumberandrevisionindicatethecurrentedition.Theprintingdate

changeswhenanewrevisionisprinted.(Minorcorrectionsandupdateswhichare

incorporatedatreprintdonotcausethedatetochange.)Thedocumentrevisionletter

changeswhenextensivetechnicalchangesareincorporated.

Contents

Contents 1

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

Copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-ii

Proprietary Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-ii

Chapter 1: Important Information

Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

System Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

Document Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Equipment Classification (According to IEC 60601-1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Electromagnetic Compatibility (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Radios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Using Batteries Safely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9

List of Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10

Examining the Contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15

Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16

Disposing of the Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16

Rear Panel Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16

Replacing Cart Batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17

Connecting AC Mains Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18

MR200 Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19

Attaching the SPO2 Sensor to the wSPO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20

Charging Module Batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20

Replacing a Module Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20

Assigning the Network Channel of a Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21

Changing the Network Channel of a Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22

Advanced User Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24

Expression Information Portal (Model IP5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24

Additional Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-25

Accessory List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-25

Chapter 2: System Overview

System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Use Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1

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

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

Device Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3

Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Speaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Storage Basket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Module Holders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

Wireless Processing Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

2 Contents

Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Wheel Locks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Battery Compartments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Guide Handles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Patient Connection Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Display and Control Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Positioning the MR200. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Wireless Modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

wECG Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

wSPO2 Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Module Status Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

System Power-Up and Communications Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

System Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

Display Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10

Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Control Knob. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

Status Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

LCD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

Display Areas. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

Informational Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Vital Sign Boxes Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

No Data Available Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Communication and Power Status Display Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16

Vital Sign Traces Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17

Modes of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18

Normal Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18

Suspend Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18

Simulation Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19

Chapter 3: Getting Started

Monitor Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1

Initial Alarm Setting Indication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

SETUP Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

MONITOR Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

RECALL SETUPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

STORE SETUPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

PARAMETER SELECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

SOUND ADJUST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

PATIENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

PEDIATRIC ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

SET TIME. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

DEFAULT SETUPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

SWEEP SPEED. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14

RESP SPEED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14

NETWORK. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

SERVICE(BIO-MED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Contents 3

Chapter 4: Monitoring ECG

wECG Module and Lead Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1

Defibrillator Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Patient Preparation for ECG Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

ECG Site Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

ECG Quadtrode Electrode Types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

Selecting the Quadtrode Electrode and ECG Lead Cable. . . . . . . . . . . . . . . . . . . . . . . .4-4

Selecting the Quadtrode Electrode Placement Site. . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

Preparing the ECG Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

Checking Electrode Contact Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

Attaching the Lead Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

Lead Failure Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10

Positioning the wECG Module and Lead Cable for Scanning . . . . . . . . . . . . . . . . . . . . . . . .4-11

Minimizing the Risk of MRI-Related Heating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12

Checking the ECG Signal Strength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13

Selecting the Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13

Changing the Lead View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14

Selecting the Filter Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15

ECG Waveforms and VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16

Changing the Waveform Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17

Changing the Heart Rate Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17

ECG Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18

ALARM LIMITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19

TRACE A LEAD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20

TRACE B LEAD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20

SCALE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

GATING SOURCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

HR SOURCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-22

HR TONE SOURCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-22

FILTER MODE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23

ECG TEST SIGNAL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-24

T-WAVE SUPPRESSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-25

MAGNET CONTROL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-25

Using the Gating Feature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26

Using ECG Gating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26

Using SPO2 Gating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27

Chapter 5: Monitoring SPO2

wSPO2 Module, Sensor and Attachment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Patient Preparation for SPO2 Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

Selecting the Site and Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

Attaching the Clip or Grip to the SPO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

Applying the SPO2 Attachment to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3

Positioning the wSPO2 Module for Scanning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5

SPO2 Waveform and VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Changing the Waveform Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7

Changing the SPO2 Waveform Amplitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8

Changing the SPO2 Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8

Assessing Suspicious SPO2 Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

4 Contents

SPO2 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9

ALARM LIMITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

SIZE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

AVERAGING TIME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

GATING SOURCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

HR SOURCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

HR TONE SOURCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

Chapter 6: Monitoring NiBP

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

Selecting the NiBP Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Positioning the NiBP Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Connecting the NiBP Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Choosing the Measurement Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Selecting Auto Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Making Manual Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

Initial Inflation Pressures and Reading Durations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

Stopping an NiBP Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

NiBP VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-7

Systolic/Diastolic Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Mean Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

Changing the NiBP Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

Changing the Unit of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

NiBP Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11

ALARM LIMITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12

INTERVAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12

AUTO MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13

HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13

FORMAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14

Chapter 7: Monitoring CO2

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

Selecting the CO2 Accessory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Connecting the Sampling Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Applying the Sampling Line to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

CO2 Waveform and VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Changing the Waveform Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Changing the CO2 Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

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

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

ALARM LIMITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

SIZE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

GRIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

ZERO CAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10

UNIT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10

Contents 5

Chapter 8: Monitoring RESP

Patient Preparation for RESP Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Monitoring Respiration using CO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1

Monitoring Respiration using the Bellows. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1

Bellows Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

Respiration VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3

Changing RESP Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4

RESP Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5

ALARM LIMITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5

SOURCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6

Chapter 9: Alarms

Alarm Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1

Alarm Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1

Status and Technical Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1

Physiological Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2

Enabling Print on Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2

Controlling Alarm Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Latched and Unlatched Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-3

Showing or Hiding Current Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-3

Setting Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-4

Setting Alarm Limits Globally. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-4

Setting Alarm Limits Individually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5

Restoring Default Alarm Limit Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-6

Controlling the Alarm Sound. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-7

Adjusting the Alarm Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-7

Silencing the Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-7

Alarm Hold Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-8

ALARMS Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-8

SET INDIVIDUAL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-10

CALCULATE ALL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-10

UPPER WINDOW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-11

LOWER WINDOW. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-11

ALARM SOUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-12

DEFAULT LIMITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-12

TYPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-13

LIMITS DISPLAY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-13

Testing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-13

Adjustable Alarm Limit Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-14

Alarm Limit Defaults. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-15

Listing of Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-16

Status and Technical Alarm Indications and Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-16

Physiological Alarm Indications and Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-23

Chapter 10: Trend Data and Printing

Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

Tabular Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1

Viewing Multi-Parameter Tabular Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2

6 Contents

Graphical Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

Viewing Individual Trend Graphical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3

Viewing Multi Trend Graphical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4

HISTORY Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

PREV PAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

NEXT PAGE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

CLEAR ALL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

MULTI TRENDS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7

TREND ARROWS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8

ARROW PERIOD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8

Print Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9

PRINTER Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9

TRACE 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11

TRACE 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12

TRACE DELAY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12

Chapter 11: Cleaning and Maintenance

Environmental Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

General Cleaning Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

Cleaning the Cart and Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2

Sterilizing the Cart and Wireless Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4

Cleaning the Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4

Sterilizing the Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Inspecting the Accessories for Damage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

Storing the Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

Final Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

Disposal of the Device and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

Disposing of Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8

Testing CO2 Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8

Testing the NiBP System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8

Default Initialization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10

Updating Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10

SERVICE(BIO-MED) Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12

S/W REV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13

SIMULATION MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14

NiBP TESTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14

GAS CAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14

SERVICE UTILITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15

SYSTEM CONFIG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15

Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-16

Passing This Product on to Another User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-17

Packaging the MR200 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-18

Appendix A: Specifications

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

Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Power Requirements, Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

Contents 7

Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

Dimensions and Weights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

Liquid Crystal Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

Displayed Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4

ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4

ECG Amplifier. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

Heart Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

Cardiotach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

Alarm Limits (HR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5

Test/Calibrations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5

ECG Supplemental Information, as required by IEC 60601-2-27. . . . . . . . . . . . . . . . . . . . . . A-5

Pulse Oximeter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-6

Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6

Non-Invasive Blood Pressure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-7

General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7

Pneumatic Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7

Measurement Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7

Accuracy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7

Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8

Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8

CO2 (Optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-9

Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10

Bellows Respiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-11

Gating Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-11

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: Guidelines and References

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

nance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1

References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3

Notes

8 Contents

ExpressionMR200InstructionsforUseImportantInformation1‐1

CHAPTER 1

Important Information

ImportantuserinformationabouttheExpressionMR200MRIPatientMonitoringSystemand

contactinformationforRoyalPhilipsisdiscussedhere.

Informationregardingthesafety,accessories,assemblyandoperationofafullyequipped

ExpressionMR200MRIPatientMonitoringSystemcanbefoundinthisdocument.Some

informationmaydepictmonitoringfeaturesnotpresentonyourMR200.Forinformationabout

allfeaturesandenhancements,contactusoryoursalesrepresentative:

Invivo

Orlando,FL32826

U.S.A.

877‐468‐4861

www.invivocorp.com

Foradditionalinformationaboutyouraccessories,pleaseconsultthedocumentationthat

accompaniestheaccessory.

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

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

theinstructionsprovided.

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

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

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

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

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

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

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

servicepersonnel.

NOTE

Laws in the United States restrict sale of this device on the order of a physician.

Intended Audience

ThisInstructionsforUse(IFU)manualfortheExpressionMR200MRIPatientMonitoringSystem

isintendedforusebyhealthcareprofessionalstrainedintheuseoftheequipmentandvitalsigns

monitoring.

1‐2ImportantInformationExpressionMR200InstructionsforUse

Indications for Use

TheExpressionMR200MRIPatientMonitoringSystemisintendedforusebyhealthcare

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

forsynchronizationoftheMRIscanner.TheExpressionMR200providesmonitoringforthe

followingvitalsignparameters:ECG,pulseoximetry(SpO2),non‐invasivebloodpressure(NiBP),

and(optional)carbondioxide(CO2).

NOTE

The Expression MR200 is intended to be used to monitor the vital signs of a patient in an MR

magnet room. This system is not intended for use on a patient being transported outside of a

health care facility.

Conventions

CertainconventionsareusedthroughouttheExpressionMR200MRIPatientMonitoringSystem

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

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

System Conventions

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

•Thedisplaypanelincludesacontrolknobandakeypad.

–Pressakeytoactivateordeactivateitsfunctionortoviewitsmenu.

–Turnandpressthecontrolknobtonavigateandselectmenuoptions,submenus,

itemsorvalues.

•AllmenuscontainaRETURNoptionthatclosestheopenmenu.

•Mostmenusemployatime‐outfeaturewhere,ifnoactionistakenforapproximately60

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

•Toprotectagainstaccidentalchanges,aYES/NOpromptisassociatedwithsomemenu

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

approximately60secondswillbeequivalenttoselectingNO(thiscanalsobeaccomplished

bypressingtheMainkey.)

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

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

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

ExpressionMR200InstructionsforUseImportantInformation1‐3

Document Conventions

Thesedocumentconventionsareused:

•TheExpressionMR200MRIPatientMonitoringSystemwillhereafterbereferredtoasthe

MR200.

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

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

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

•Controlnames,menuitems,vitalsignreferences,etc.,arespelledastheyappearinthe

MR200.

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

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

•Messagesregardingaconditionorsysteminformationaregiveninbolduppercaseletters.

•TheleftsideoftheMR200isonyourleftasyoustandinfrontofthesystem,facingit.The

frontoftheMR200isnearestyouasyouoperateit.

•Thefrontofthemoduleisnearestyouasyouoperateit.

Warnings

Warning

WARNING

Warnings provide information you should know to avoid injuring yourself, patients or

personnel.

Cautions

CAUTION

Cautions provide information you should know to avoid damaging the equipment and software.

Notes

NOTE

Notes provide additional information you should know regarding usage.

Step Action

1

2

3

1‐4ImportantInformationExpressionMR200InstructionsforUse

Contraindications

Refertoallwarnings.BeforeusingtheMR200,readthewarningsandthesafetyinformation

below.ThewarningsbelowrefertotheMR200initsentirety.

WARNINGS

•Thoroughly read and understand these Instructions for Use prior to use of the MR200.

• A shock hazard exists if the MR200 is operated without the covers installed.

• Only use only supplied power cords and connect to properly grounded AC outlets to

avoid electrical shock.

• Ensure that the monitor settings are appropriate for the patient being monitored.

•The patient must remain calm and motionless while the MR200 is being used. If the

patient is overactive, prolonged or inaccurate readings may result.

• Position of the accessories may affect measurement accuracy. Always consult a

physician for interpretation of measurements provided by the MR200.

• Perform operational verification prior to use. If the MR200 fails to function properly,

remove it from use and contact technical support personnel.

• Screen all patients for metallic wires, implants, stents, etc. 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.

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Safety

CAUTION

To minimize risk of damage to the monitor during defibrillation use only approved supplies.

Electromagnetic Compatibility (EMC)

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

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

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

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

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

Radios

FrequencyRange:2401.7–2469.8MHz

ModulationType:GFSK

WPUEIRP:4.2dBm(peak)

wECGandwSPO2EIRP:0dBm(peak)

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 protection against

harmful ingress of water:

IPX0 (ordinary) protection against ingress

of fluids

According to the methods of sterilization or

disinfection:

Non-sterilizable; use of liquid surface

disinfectants only

According to the mode of operation: Continuous operation

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

oxygen or nitrous oxide.

1‐6ImportantInformationExpressionMR200InstructionsforUse

WARNINGS

•Operation of the MR200 outside the specifications indicated in Appendix A will cause

inaccurate results.

• The use of portable and mobile radio-frequency (RF) communications equipment can

affect the operation of this device.

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

accessory list accompanying these 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.

• The MR200 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.

• The MR200 needs to be installed and put into service according to the EMC

information provided in the instructions for use. Portable and mobile RF

communications equipment can affect medical electrical equipment. The MR200 may

be interfered with by other equipment with CISPR emission requirements.

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

The MR200 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 MR200 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 MR200 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

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Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The MR200 is intended for use in the electromagnetic environment specified below. The customer or the user of the

MR200 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 MR200 requires

continued operation during

AC power interruptions,

power from an

uninterruptable 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.

1‐8ImportantInformationExpressionMR200InstructionsforUse

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The MR200 is intended for use in the electromagnetic environment specified below. The customer or the user of the

MR200 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

MR200, 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 MR200 is used exceeds the applicable RF compliance level above, the MR200 should be

observed to ensure normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-

orienting or relocating the MR200.

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

P

ExpressionMR200InstructionsforUseImportantInformation1‐9

Using Batteries Safely

Batterieshavelifecycles.Whentheequipmentoperatingtimeprovidedbybatterypower

becomesmuchshorterthanusual,thebatterylifeisatanend.Immediatelyremoveanybattery

thathasanexpiredlifecycleandreplaceitwithanewbatteryofthesametype.(Refertopage1‐

28forpartnumbers.)Toensurethesafetyofoperatorsandpatients,observethefollowing

warningsandcautions.

Warning

WARNING

Stop using 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.

Recommended Separation Distances between Portable and Mobile RF Communications

Equipment and the MR200

The MR200 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

The customer or the user of the MR200 can help prevent electromagnetic interference by maintaining a minimum

distance between portable and mobile RF communications equipment (transmitters) and the MR200 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

1‐10ImportantInformationExpressionMR200InstructionsforUse

Caution

CAUTIONS

• If the battery contacts become dirty, wipe them clean with a dry cloth before use.

• Store batteries in a dry place, between 0°C to 40°C.

• Keep metal objects away from the battery contacts.

List of Symbols

ThesymbolsinthefollowingtablemayappearontheMR200,thepackingmaterials,orinthis

manual.

Symbol Meaning Symbol Meaning

CSA certified for both the

U.S. and Canadian markets

Federal Communications

Commission radio

certification

Underwriters Laboratories

Component Recognition

Mark for both the U.S. and

Canadian markets

Taiwan National

Communications Commission

certification

Korean Communications

Commission radio

certification

Conforms to the Medical

Device Directive

MR Conditional: Use in the

MR environment is restricted

to certain conditions of use

to ensure patient and

operator safety.

Conforms to the R&TTE

Directive (Radio &

Telecommunications

Terminal Equipment)

MR Conditional: Use in the

MR environment is restricted

to certain conditions of use

to ensure patient and

operator safety.

MR unsafe

ExpressionMR200InstructionsforUseImportantInformation1‐11

Warning! Specific warnings

associated with the devices

that are not otherwise found

on the label; when located on

the wECG module

connector, indicates that only

specified ECG cables shall be

used to ensure safe use in the

MR and defibrillation

protection.

Caution! Specific warnings or

precautions associated with

the devices that are not

otherwise found on the label

MR safe

MR safe Mandatory action: Follow the

Instructions for Use

Consult the Instructions for

Use

Single use only, disposable

one-time-use product; do not

reuse

Do not adjust without

referring to the service

manual

Defibrillator-proof type CF

equipment (IEC 60601-1)

protection against shock

Use by date (do not use after

the year, month or day

shown)

Serial number

Authorized representative in

the European Community Batch code/lot number

Catalog, reorder or

reference part number Direct current

Alternating current Neonate

Infant Adult / Pediatric

Symbol Meaning Symbol Meaning

1‐12ImportantInformationExpressionMR200InstructionsforUse

Toe site Thumb site

Finger site Foot site

Toe site Temperature range

Prescription only NiBP cuff, wrong side out

NiBP cuff, correct side out NiBP cuff circumference

range

Weight Keep dry

Humidity range Atmospheric pressure

limitation

Fragile Up

Patient ECG

Symbol Meaning Symbol Meaning

ExpressionMR200InstructionsforUseImportantInformation1‐13

Non-invasive blood pressure

(NiBP) Universal Serial Bus (USB)

Contains no latex

Dispose of the battery or

electronic waste in

accordance with your

country’s requirements

Non-ionizing radiation Pneumatic respiration

Cardiac gating output Input connection

Manufacturer name and

address information

Date of manufacture, YYYY-

MM

Conforms to the RoHS

directive Battery

Non-magnetic part Wheel lock, press to engage

Do not move the MR200

inside the 1,500 gauss field

line of the MR magnet or

within 1.5 m (4.9 feet),

whichever is greater, as

measured from the center

line of the bore.

Apply wheel locks and do not

move the MR200 inside the

1,500 gauss field line of the

MR magnet or within 1.5 m

(4.9 feet), whichever is

greater, as measured from

the center line of the bore.

Main key

NiBP key Trends key

Symbol Meaning Symbol Meaning

mp

1‐14ImportantInformationExpressionMR200InstructionsforUse

Print key Patient key

Silence key Setup key

Alarm sound on Suspend key

Alarm sound on hold Power switch

Alarm sound silenced Alarm sound off

Current setups have changed Heartbeat detected

On AC power Breathing effort detected

wECG battery time

remaining Good battery power

wSPO2 battery time

remaining No AC, on battery power

No MR200 communication

with the wECG module Low battery power

Network channel A No MR200 communication

with the wSPO2 module

Network channel B Network channel C

Symbol Meaning Symbol Meaning

ExpressionMR200InstructionsforUseImportantInformation1‐15

Examining the Contents

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

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

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

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

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

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

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

• MR200

•Twocartbatteries

• InstructionsForUse(IFU)manual

•QuickReferenceGuide

•PowerCord

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

• WirelessECGmodule

• WirelessSPO2module

•Modulebatterycharger

•Modulebatteries

Network channel D Network channel E

Cart connected to AC mains,

batteries installed

Cart connected to AC mains,

batteries not installed

Printer ready Printing in progress and time

remaining, in seconds

No printer available Printer not ready

Symbol Meaning Symbol Meaning

1‐16ImportantInformationExpressionMR200InstructionsforUse

Assembly

Thissectionprovidesimportantinformationaboutassemblyandsystemrequirements.Observe

thewarningsandcautionsthatappearthroughoutthismanualwhenassemblingandusingthe

MR200.Forthelocationofcartcomponentsnotdetailedbelow,seetheillustrationonpage2‐3.

Warning

WARNING

Only perform assembly of the MR200 at a location outside of the MR magnet room. Failure

to observe this warning may result in serious injury.

CAUTION

The MR200 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.

Disposing of the Packaging

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

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

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

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

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

Rear Panel Connections

Hardwareinterfaceandpowerconnectionsareprovidedontherearpanelofthecart.

Gatingconnector

Presentsoutputsforgatingconnections

totheMRsystem.Removetheshield

capfromthegatingconnectorthen

installagatingcable.(Cablesaretype‐

dependant;seepage1‐26.)

USBport

AllowsUSBthumbdriveconnectionsfor

MR200softwareupdatesonly.(See

UpdatingSoftwareonpage11‐10.)

Gating connector

USB port

AC inlet

Strain relief

ExpressionMR200InstructionsforUseImportantInformation1‐17

ACInlet

IstheinputconnectionforACvoltagetothecart.

Strainrelief

SecurestheACpowercordtothecart.

Caution

CAUTIONS

• When making connections to the rear panel of the MR200, ensure that the final installation

complies with IEC/EN 60601-1-1, General Requirements for the Safety of Medical

Electrical Systems, to assure operator and patient safety. Always check the summation of

leakage currents when the MR200 is connected to additional external equipment.

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

is in doubt, the MR200 shall be operated from batteries.

Replacing 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 MR200. The batteries will be attracted

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

CAUTION

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

Cartbatterieswillslideandlatchinto

placeinthebatterycompartmentsin

thebaseoftheunit:

•Wheninstallingbatteriesthey

mustbeorientedproperly,as

thebatteryshapeisdesignedto

fitthecontourofthebattery

compartment.

•Ifthebatterydoesnotlatch

intoplacewhenfullyinsertedin

thebatterycompartment,then

itisnotproperlyoriented.In

thiscase,removeandreorient

thebatterythenreinsertitintothebatterycompartment.

Battery

compartments

Cart batteries

1‐18ImportantInformationExpressionMR200InstructionsforUse

Toinstallcartbatteries

Orientabatteryforinsertion(labelsidedown,connectorfacingforward)thenslideitintoa

batterycompartment.Whenproperlyinserted,thebatterywilllatchintoplace.A“click”willbe

heardandthebatterywillbeflushwiththefaceofthebatterycompartment.Repeattheprocess

fortheremainingbattery.

NOTE

Before initial use, charge the batteries for at least 12 hours with the MR200 turned off and

connected to AC mains power.

Toremoveacartbattery

Pressthebatteryeject

button(locatedonthe

undersideofthebattery

compartment).

(Ifthebatterydoesnot

release,applyaslight

forwardpressureonthe

batterywhilepressingthe

ejectbutton.)

Repeattheprocessto

removetheremaining

battery.

Connecting AC Mains Power

CAUTION

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

safety hazard by compromising the grounding integrity of the MR200.

ToconnectACmainspower

Cart batteries

Battery eject buttons

Step Action

1Ensurethatthecartbatteriesareinstalled;seepage1‐18for

details.

2PositiontheMR200;seepage2‐6.

3Raisethestrainrelief.

4ConnecttheACpowercordtotheACinletontheMR200.For

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

alsobeconnected.

ExpressionMR200InstructionsforUseImportantInformation1‐19

ToremovetheMR200fromACmainspower

PullouttheplugatthewalloutletandthenremovetheACpowercordfromtheMR200.Store

thecordinasafeplace.

MR200 Battery Operation

Warning

WARNING

Do not touch the internal battery compartments of the cart and the patient simultaneously.

Cartbatteriesarechargedandconditionedbyanintegratedintelligentchargingsystem.When

turnedon,theMR200operatesfromACpowerandsimultaneouslychargesthebatteries.When

connectedtoACpowerandturnedoff,thebatterychargerremainsfunctionalandcharging

occursautomatically.IfACvoltageislost,theMR200willautomaticallyswitchtobatterypower

toprovideuninterruptedservice.

NOTES

• To prevent unintentional power interruptions, it’s highly recommended to always keep the

batteries inserted in the MR200 even when operating on AC power.

• If the MR200 will not be used for more than 3 days, remove the batteries or keep AC power

connected.

MaximumMR200operationtimeunderbatterypoweris

approximately8hours,butthismaybereducedbyupto2

hourswhencertainoperationsareperformed—suchasrunning

NiBPcyclesatlessthan5‐minuteintervals.

Visualindicationofthechargedcapacityisdisplayedbythe

cartstatusicon(seepage2‐16).

Chargedcapacitycanalsobeseenbypressingthepowerlevel

buttononeachcartbattery,wherethecapacityisindicatedin

20percentincrements.

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

6ConnecttheACpowercordtoanapprovedACmainsoutlet.

Step Action

Power level button

Cart battery

1‐20ImportantInformationExpressionMR200InstructionsforUse

Attaching the SPO2 Sensor to the wSPO2 Module

WARNINGS

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

observe this warning may result in serious injury.

• Connecting other than specified SPO2 sensors to the wSPO2 module can cause

inaccurate SPO2 readings and damage the module.

ToattachtheSPO2sensortothewSPO2module

InserttheSPO2sensortotheDB‐9connectoronthewSPO2

module.Then,usingastandardscrewdriver,securelytighten

bothscrews.

Charging Module Batteries

Modulebatteriesarechargedinthemodulebatterycharger.Refertotheinstructionsprovided

withthemodulebatterychargerforplacementanduseinformation.

Replacing a Module Battery

Eachwirelessmodulehasslotslocatedonbackofthedevicetohousethebattery.Module

batteriesareinterchangeable,non‐magnetic,andcanbehandledintheMRmagnetroom.For

operationalinformationaboutthewirelessmodules,seepage2‐7.

CAUTION

To minimize the chance of image artifacts, never place module batteries in the MRI field of view.

SPO2 sensor

Screws

wSPO2 module

DB-9 connector

ExpressionMR200InstructionsforUseImportantInformation1‐21

Toinstallamodulebattery

Orientthebatteryasshownandthenslide

thebatterybetweentheslotsonbackof

themoduleuntilbothtabslatchinto

place.Storethemodulesinthemodule

holdersonthecart;see2‐5fordetails.

Toremoveamodulebattery

Usingthethumbandindexfingerofone

hand,pressthetabsinwardandhold.

Thenplacethethumborafingerofyour

otherhandontherecessandpushthe

batteryoutofthemodule.

Assigning the Network Channel of a Module

NOTE

The modules for your system may arrive pre-programmed to match the network setting of the cart.

Inorderforamoduletocommunicatewith

theMR200,thewirelessnetworksettingof

eachmustbethesame.

Thecurrentsettingofamoduleis

indicatedbyitsilluminatednetworkicon.

Foreaseofrecognition,e

achnetworkicon

hasauniqueletter(A–E),shapeandcolor.

(ThesettingfortheMR200isdisplayedon

theLCD;seepage2‐16.)

Thewirelessnetworkchannelforthemoduleischangedbyusingthenetworkbuttonlocated

underneaththelabelinthefrontupperleftcornerofthedevice;seetheillustrationbelow.(You

willbeabletofeelaslightbumpwhenyoupassafingeroverthebuttonarea.)

Thefollowingdirectionsforchangingthenetworkchannelapplytobothwirelessmodules,

thoughtheprocessbelowdepictsonlythewECGmodule.

Battery

Module

Slots

Tabs

Battery

Tabs

Recess

Network icons

Button area

1‐22ImportantInformationExpressionMR200InstructionsforUse

Topressthenetworkbutton

Placethemoduleonaflatsteadysurface(orholdthemoduleasshownin

thefigure,right)andthenuseyourthumbtopressthenetworkbutton.

Changing the Network Channel of a Module

Beforestartingtheproceduretochangethenetworkchannelofthemodule,takenoteofthese

conventionsthatareusedtoexplaintheprocess:

•Intheprocedurebelow,thefollowingsymbolsareusedtoconveythestateofthenetwork

icononawirelessmodule.

.

•Intheprocedurebelow,thefollowingillustrationsareusedtoconveyactionsconcerning

theuseofthenetworkbutton.

Tochangethenetworkchannelofawirelessmodule

Iconilluminated Iconblinking

Pressingthe

button

Releasingthe

button

Pressingandholding

thebutton Repeating

Step Action

1Turnoffthemodulebyremovingthebattery;seepage1‐21.

ExpressionMR200InstructionsforUseImportantInformation1‐23

2Insertabatteryintothemodule;seepage1‐21.

Thenetworkiconswillflashbrieflyandthenthecurrentnetwork

iconwillilluminate(forexample,“C”intheillustrationbelow).

3 Enterthenetworkchangemode:Afterthecurrentnetworkicon

hasbeenilluminated(andwithin15secondsfrommodulepower‐

up)pressandholdthenetworkbuttonuntilthecurrentnetwork

iconbeginstorapidlyblinkthenreleasethebutton.

NOTE

If the network change sequence was not started within 15 seconds

after the module has been turned on, network changes will not be

allowed. In this case, you must cycle module power and restart the

sequence.

4Pressdownagainonthebuttonuntiltheiconstopsblinkingand

thenreleasethebuttontochangethenetworksetting.

Whenyoudothis,thenextnetworkiconinthesequencewillblink

rapidly.(Inotherwords,ifthemodulewasoriginallyusingnetwork

“C,”nowthe“D”iconwillbeblinking.)Repeatthissequenceof

pressingdownandreleasingthebuttonuntiltheiconofthe

networkyoupreferisrapidlyblinking.Ifyoupassthedesired

network,simplycontinuepressingandreleasingthebuttonuntil

thedesirednetworkisblinkingagain.

Step Action

1‐24ImportantInformationExpressionMR200InstructionsforUse

Advanced User Options

Expression Information Portal (Model IP5)

ProvidingsystemcontroloutsidetheMRmagnetroom,the

ExpressionInformationPortal(ModelIP5),hereafterreferred

toastheIP5,isawirelessdevicethatalsofeaturesprinting

capabilitiesandHL7dataoutputoptions.

5Whenyoureachthedesiredicon,pressandholdthebuttonfor

approximately5secondstolockandsavethenewsetting.

Theselectednetwork'siconwillturnoffwhilethebuttonis

depressed.Thenitwillilluminate(notblink)whenthenewnetwork

settingissaved.Onceilluminated,releasethebutton.Themodule

willbeginusingtheselectednetworkchannel.

NOTE

Any part the network change sequence not completed will cause the

module to revert to the network previously set 30 seconds after the

network button was last released.

Step Action

ExpressionMR200InstructionsforUseImportantInformation1‐25

Additional Options

Additionaloptions,suchasthoselistedbelow,maybesuggestedbyyourbiomedicaltechnician

toincreaseuserease.TheMR200isconfiguredwithinput/outputportstopermittheconnection

ofexternalequipment,including:

• Facilityinformationsystems

•GatingsourceforMRIfunctions

•USBportforsoftwareinstallation

Consultyourbiomedicaltechnicianortechnicalsupportwithspecificrequests.

Caution

CAUTIONS

• When adding equipment to an MR200 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, etc.

• 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 MR200 system or device communications.

Accessory List

Accessoriesarelistedinthetablesbelowwithpartnumber(REF)information.

CAUTION

The MR200 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 MR200.

CO2 REF

LOFLO SAMPLE LINE, ADULT CANNULA, BOX 20 989803183241

LOFLO SAMPLE LINE, PED. CANNULA, BOX 20 989803183251

LOFLO SAMPLE LINE, NEO. CANNULA, BOX 20 989803183261

LOFLO LINE, ADU DVD CANNULA,BOX 20 989803183271

LOFLO LINE, PED DVD CANNULA, BOX 20 989803183281

LOFLO LINE, ADU AIRWAY ADPT, BOX 20 989803183291

1‐26ImportantInformationExpressionMR200InstructionsforUse

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

ECG REF

GEL, ECG/EEG, SKIN PREP, TUBE, 3-PACK 989803152291

CAB, 4 LD, MRI ECG 989803152301

CAB, 4 LD, NEO.MRI ECG 989803152331

CAB, 4 LD, CV MRI ECG 989803152351

ADVANCED APPS ECG CABLE 989803176381

ADVANCED FILTER ECG CABLE 989803170121

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 989803183661

CAB, 4 LD, NEO.MRI ECG, IEC 989803185441

CAB, 4 LD, CV MRI ECG, IEC 989803185451

CAB, 4 LD, MRI ECG, IEC 989803185461

ADVANCED FILTER ECG, IEC 989803185471

ADVANCED APPS ECG CABLE, IEC 989803185481

Gating Cables REF

CAB, DIGITAL GATING, GE, 3160 989803152821

CAB, GATING, SIEMENS, 3160 989803152831

CAB, GATING, PHILIPS ACH, 3160 989803152841

CAB, DIG.GATING, HIT/TOSH, 3160 989803152851

CO2 REF

ExpressionMR200InstructionsforUseImportantInformation1‐27

Non-invasive Blood Pressure 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, SAMPLE KIT,DISP 989803182591

NIBP CUFF, SINGLE LUMEN, NEO #1, DISP 989803183171

NIBP CUFF, SINGLE LUMEN, NEO #2, DISP 989803183181

NIBP CUFF, SINGLE LUMEN, NEO #3, DISP 989803183191

NIBP CUFF, SINGLE LUMEN, NEO #4, DISP 989803183201

NIBP CUFF, SINGLE LUMEN, INFANT #5, DISP 989803183211

ADULT PRESSURE INTERCONNECT HOSE 989803183221

NEONATAL PRESSURE INTERCONNECT HOSE 989803183231

Pneumatic Respiration REF

PNEUMOGRAPH,CHEST,NM,3160 989803152791

1‐28ImportantInformationExpressionMR200InstructionsforUse



Power REF

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

POWER CORD, DANISH, 3 METER 989803181331

POWER CORD, ISRAELI, 3 METER 989803181341

POWER CORD, ARGENTINA, 3 METER 989803181351

POWER CORD, SWISS, 3 METER 989803181361

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 989803183541

System REF

ASSY, 3.7V BATTERY CHARGER, 3160 989803152891

BATT.3.7V,WRLS.PAT.MDLE 989803152881

BATTERY, MRI, 14.8V, 5.08 AH, UL 989803169491

HANDLE HOOK, HOSE MANAGEMENT 989803185121

EXPRESSION INFORMATION PORTAL (IP5) 865471

ExpressionMR200InstructionsforUseImportantInformation1‐29

Miscellaneous REF

PAPER, THERMAL ARRAY, BLK, 50MM, OMNI MP05

QUICK REFERENCE GUIDE, MR200 453564357851

MANUAL, SERVICE, MR200 989803181911

MANUAL, OPERATORS, MR200, ENGLISH 989803184961

MANUAL, OPERATOR, MR200, DANISH 989803181971

MANUAL, OPERATOR, MR200, DUTCH 989803181981

MANUAL, OPERATOR, MR200, FINNISH 989803181991

MANUAL, OPERATOR, MR200, FRENCH 989803182001

MANUAL, OPERATOR, MR200, GERMAN 989803182011

MANUAL, OPERATOR, MR200, ITALIAN 989803182041

MANUAL, OPERATOR, MR200, NORWEGIAN 989803182051

MANUAL, OPERATOR, MR200, POLISH 989803182061

MANUAL, OPERATOR, MR200, PORTUGUESE 989803182071

MANUAL, OPERATOR, MR200, SPANISH 989803182091

MANUAL, OPERATOR, MR200, SWEDISH 989803182101

MANUAL, OPERATOR, MR200, TURKISH 989803182111

MANUAL, OPERATOR, MR200, JAPANESE 989803190941

MANUAL, OPERATOR, MR200, RUSSIAN 989803190951

MANUAL, OPERATOR, MR200, KOREAN 989803191221

MANUAL, OPERATOR, MR200, TRADITIONAL 989803191231

MANUAL, OPERATOR, MR200, INDONESIA 989803191351

1‐30ImportantInformationExpressionMR200InstructionsforUse

ExpressionMR200InstructionsforUseSystemOverview2‐1

CHAPTER 2

System Overview

FamiliarizeyourselfwiththeMR200anditscomponents.TheMR200combineswireless

communications,radiofrequencyshieldinganddigitalsignalprocessingtechnologiestoprovide

accurate,continuousandreliablepatientmonitoringperformanceinthedynamicmagnetic

resonanceenvironment.

ThemonitoringcapabilitiesoftheMR200canbeconfiguredtomeettheneedsofawide

spectrumofpatientsfromneonatetoadult.Everyparametercanbeaccessedandadjustedfor

theuniqueconditionofeachpatient.TheMR200accommodatesspecificmonitoringneeds,

including:

•Adult,pediatricandneonatalpatients

•Criticallyillpatients

•Patientundergoingsedation

•PatienttransportwithintheMRenvironment

• Interventionalprocedures

•Cardiacgating

System Components

AcompleteMR200systemconsistsofthefollowingcomponents:

•Cart

• WirelessECGmodule

• WirelessSPO2module

•Modulebatterycharger

• Batteriesandotheraccessoriesasneeded

•OptionalIP5andprinter

Use Model

Asillustratedbelow,theMR200isintendedtobeusedtomonitorthevitalsignsofapatientinan

MRmagnetroom.WhenpairedwiththeoptionalIP5,monitoringcapabilitycanbeextendedtoan

MRcontrolroom,inductionroom,orrecoveryroomenvironmentandthegathereddatacanbe

outputtoastripchartprinterorhospitalinformationsystem(HIS).

2‐2SystemOverviewExpressionMR200InstructionsforUse

Acquisition and Control

TheuseoftheMR200isrestrictedtoonepatientatatime.TheMR200displayspatient

measurementsacquiredduringmonitoring.Controlsandsettingsforpatientmonitoringare

providedlocallyatthedisplaypanelorremotely(forexample,intheMRIcontrolroom)when

equippedwiththeIP5,whereconnectionsfortheprinterandthehospitalnetworkarealso

available.

Synchronization

TheMR200willautomaticallyestablishcommunicationwiththewirelessmodulesandIP5(if

equipped).However,duetotheusemodel,thedevicescanestablishcommunicationand

synchronizepower‐onsettingsdependinguponthestart‐upsequence:

•IftheMR200bootsfirst,thenitssettingswillbereflectedattheIP5.

•IftheIP5bootsfirst,thenitssettingswillbereflectedattheMR200.

IfusinganIP5,patientidentifiableinformation(name,IDnumber,etc.)willbeavailableafter

synchronizationoccurs.

MR200

IP5

Hospital network

HIS system

MRI magnet room

MRI control room

Patient

bed

MR200 to IP5 (wireless)

Modules to

MR200

(wireless)

USB

Ethernet

Printer

ExpressionMR200InstructionsforUseSystemOverview2‐3

WARNING

The use model specifies one IP5 per MR200 system. If more than one IP5 is present on the

MR200 system, there is an increased risk of units within the system not synchronizing and

displaying incorrect or corrupted settings.

CAUTION

If the monitor’s settings are adjusted since they were last recalled or stored (manually, or via

synchronization - if using an IP5 ), the current setup name (see page 2-14) will be appended with a

plus symbol (+). The symbol will only be removed if the current settings are saved (see page 3-5)

or if different settings are recalled (see page 3-4). Always confirm the proper settings for the

MR200 and IP5 to ensure expected monitoring functionality.

NOTE

See DEFAULT SETUPS (on page 3-13) for information about power-on settings.

Device Control

Menucommandsthatcontroltheparameterfunctionsforpatientmonitoringaresynchronized

betweentheMR200andIP5.Commandsthatdonotdirectlycontrolthepatientparameters(for

example,printerfunctions)willonlyaffectIP5.OthercontrolsettingsremainlocalizedtotheIP5

andarenotsynchronizedwiththeMR200,includingalarmsilenceandholdfunctionsandvolume

settings(foracompletelisting,seetheIP5IFU).

Cart

DesignedforuseintheMRmagnetroomandthroughouttheMRsuite,thecartisawheeled

patientmonitorwithintegratedprocessing,power,displayandcontrolassemblies.Asillustrated

below,thisself‐containedmobilesystemalsoincludesstoragesolutionsforaccessories.

2‐4SystemOverviewExpressionMR200InstructionsforUse

WARNING

Never store ferrous items on the cart or in the storage basket. Failure to observe this

warning may result in serious injury.

CAUTION

Do not place more than 4 pounds (1.8 kg) of combined weight in the storage basket, module

holders and on the optional hose management handle hooks (not shown).

Speaker

Thespeakercommunicatesallaudiblesignals;seeSOUNDADJUSTonpage3‐8fordetails.

Storage Basket

ThestoragebasketprovidesconvenientplacementforCO2cannulas,NiBPcuffs,SPO2

attachmentsandQuadtrodeelectrodes.

Patient connection panel

Wireless processing unit

Battery compartments

Guide handles

Wheel locks

Speaker

Module holders

Rear panel

Storage basket

Display and control assembly

ExpressionMR200InstructionsforUseSystemOverview2‐5

Module Holders

Themoduleholdersprovidesafestorageforthewirelessmodules.

Placeawirelessmoduleinamoduleholdersothataconnected

accessoryhangsdownwardthroughtheopening.

Wireless Processing Unit

Thewirelessprocessingunit(WPU)housesthecommunication,processingandpowersystems

fortheMR200.

Rear Panel

TherearpanelcontainstheACinlet,gatingconnectorandUSBport;seepage1‐16fordetails.

Wheel Locks

Locksareprovidedoneachwheeltopreventmovementofthecart.Duringusein

theMRmagnetroom,stationthecartatasafemonitoringdistancethenpressdown

oneachwheellocktoengageit.Whenthecartneedstobemoved,raiseeachwheel

lockbeforeproceeding.(Seepage2‐6forpositioningdetails.)

WARNING

Do not move the MR200 inside the 1,500 gauss field line of the MR

magnet or within 1.5 m (4.9 feet), whichever is greater, as

measured from the center line of the bore. Always secure the

wheel locks when the MR200 is located in the MR magnet room.

Failure to properly place the MR200 in the MR magnet room will

result in monitoring system failure, and possible patient or user injury.

Battery Compartments

Thebatterycompartmentshousethecartbatteries;seepage1‐17details.

Guide Handles

Theguidehandlesprovidethemeansforpositioningthecart.

2‐6SystemOverviewExpressionMR200InstructionsforUse

CAUTIONS

• Never apply excessive force, lean against, stack or drape objects over the guide handles;

instead, use specially designed hose management handle hooks; see page 1-28 for details.

• If the MR200 rolls to the face of the MR system due to magnetically induced pull force, Do

not attempt to dislodge the MR200 by pulling from the display panel or guide handles;

instead, dislodge the MR200 by gently pulling from the lowest point of the base. This will

prevent the base of the unit from experiencing higher MR pull forces in the vertical

direction.

Patient Connection Panel

ThepatientconnectionpanelcontainsportsfortheNiBPandCO2attachments.

NOTE

Depending upon the equipped options, your MR200 may not have all indicated connections.

Display and Control Assembly

Thedisplayandcontrolassemblyhousesthedisplaypanelandspeaker,whichprovideuser

informationandsystemcontrol;seepage2‐10fordetails.

CAUTION

Never use the display and control assembly to position the cart; severe damage or failure can

result. Only use the guide handles and, if necessary, the storage basket to position the cart.

Positioning the MR200

Usetheguidehandlestomoveandpositionthecart.Alwayspositionthecartsothatyourview

oftheLCDremainsunobstructedduringuse.

TheMR200hasaninternalgausssensorwhich,incloseproximitytotheMRmagnet,

automaticallyshutsdownNiBPandCO2monitoringfunctions.Toalertyoutomovethecartaway

whenitistooclosetotheMRmagnet,theMR200willdisplaythefollowingwarningdialogbox

message:

Movemonitorawayfrommagnet.NiBPandCO2(ifinstalled)havebeenshutdown.

NiBP port CO2 port

ExpressionMR200InstructionsforUseSystemOverview2‐7

WhenpositioningtheMR200foruse,observethewarningandcautionsbelow.

WARNING

Do not move the MR200 inside the 1,500 gauss field line of the MR magnet or

within 1.5 m (4.9 feet), whichever is greater, as measured from the center line

of the bore. Always secure the wheel locks when the MR200 is located in the

MR magnet room. Failure to properly place the MR200 in the MR magnet

room will result in monitoring system failure, and possible patient or user

injury.

CAUTIONS

• If the MR200 rolls to the face of the MR system due to magnetically induced pull force, do

not attempt to dislodge the MR200 by pulling from the display panel or guide handles;

instead, dislodge the MR200 by gently pulling from the lowest point of the base. This will

prevent the base of the unit from experiencing higher MR pull forces in the vertical

direction.

• Field strength variations may require you to move the MR200 away from the MR system if

patient monitoring abnormalities or malfunctions are observed. Prior to clinical use, ensure

that the allowable distance from the MR system is maintained for proper operation because

variations in a particular MR magnet room (due to magnetic shielding techniques,

manufacturer variability, future enhancements, etc.) can make it difficult to distinguish the

1,500 gauss level, as measured from the center line of the MR bore. The MR200’s gauss

sensor can be used to determine the correct position of the cart in the MR magnet room.

Wireless Modules

ThewirelessmodulesarebatteryoperatedandcommunicatewiththeMR200througha

bidirectional2.4GHzdigitalmodulationlink,whichisautomaticallyestablishedapproximately30

secondsafterpowerisappliedtothemodule.Thewirelessmodulesoperateatupto30feet(9.1

m)fromtheMR200intheMRIroomorinthesameshieldedroom.

WARNING

The system use model specifies one wECG module and one wSPO2 module per MR200

system network. If more than one type of each module is communicating on the same

network, then waveform and measurement corruption will occur.



2‐8SystemOverviewExpressionMR200InstructionsforUse

wECG Module

ThewirelessECGmodule(wECG)transmitsmeasuredECG

signalsthroughawirelesslinktotheMR200.Themodule

alsoreceivesinformationtoperformcommandedtasks(for

example,leadconfigurationandfiltermodechanges).Two

ECGchannelscanbedisplayedandareavailablefor

interfacingwiththeMRsystemcardiacgatinginput.

wSPO2 Module

ThewirelessSPO2module(wSPO2)transmitsmeasured

bloodoxygensaturation,plethysmography,peripheralpulse

data(SPO2)andpneumaticrespirationvaluesthrougha

wirelesslinktotheMR200.Theprocessedinformationcan

bedisplayedandoutputforinterfacingtotheMRsystem

pulseperipheralandrespirationgatinginput.

Module Status Indicator

Eachmodulehasastatusindicator,atwo‐colorLED,thatdenotesthefollowingconditions.

NOTE

For battery details, see page 1-20; and, for communications details, see page 1-21.

wECG module

Status indicator

wSPO2 module

Status indicator

Indicator Module Status

Color State Power Communications

None Not

applicable

No battery is installed or the charge

is insufficient to power the module. Not applicable

Green Flashing Battery power good Not communicating

Green Solid Battery power good Good communication

Red Flashing Low battery condition Not communicating

Red Solid Low battery condition Good communication

ExpressionMR200InstructionsforUseSystemOverview2‐9

System Power-Up and Communications Verification

WARNING

Always perform operational verification prior to use and during monitoring by ensuring

proper communications between the MR200, the wireless modules and the IP5 (if equipped).

Failure to ensure proper communications can result in the loss of patient monitoring and the

loss of data transfer in networked systems equipped with an IP5. If a device fails to function

properly, remove it from use and contact technical support.

TheMR200reachesanoperationalstatewithin60secondspower‐upandattainsfull

measurementaccuracyafter2minutes.

ToapplypowertotheMR200andverifysystemcommunications

CAUTION

If power to wireless device with established communications is lost or removed, its network

connection will be dropped.

Step Action

1Ensurethatabatteryisinstalledineachwirelessmodule(seepage

1‐20).

2WiththecartbatteriesinstalledandwiththeMR200connectedto

ACpower(seepage1‐18),pressthepowerswitch.

3(Optional)ifequipped,turnontheIP5.

4Ensurethatthenetworksettingofeachmodule(seepage1‐21)

matchesthenetworksettingoftheMR200(seeonpage2‐16).

5EnsurethatthenetworksettingoftheIP5(ifturnedoninstep3,

above)matchesthenetworksettingoftheMR200.

6EnsuregoodcommunicationbetweeneachmoduleandtheMR200

bycheckingthemodule’sstatusiconontheLCD(seeonpage2‐

16).

7(Optional)ifequippedwithanIP5,proceedaccordingtotheprinter

option:

•Ifequippedwithaprinter,ensuregoodcommunication

betweentheMR200andtheIP5bycheckingtheprinting

statusiconontheLCD(seepage2‐16).

•Ifnotequippedwithaprinter,checkthedisplaypanelofthe

IP5forhostconnectiontotheMR200.

8Ensureproperoperationofeachpatientparameterandalarms.

Refertoappropriatechaptersinthismanual.

2‐10SystemOverviewExpressionMR200InstructionsforUse

System Parameters

TheMR200simultaneouslyprocessesanddisplaysmultipleparameters,waveforms,numeric

valuesandalarms.Allpatientinformationisprovidedonthedisplaypanel.Afullyequipped

MR200includesmonitoringforthefollowingparameters:

• Electrocardiogram(ECG),dualchannel

•Heartrate

•Bloodoxygensaturation/pulseoximetry(SPO2)

•Non‐invasivebloodpressure(NiBP)

•End‐tidalandinspiredCO2(CO2)

• Respiration(CO2orbellows)

NOTE

Depending upon the equipped options, your MR200 may not have all indicated parameters.

Display Panel

Thedisplaypanel,whichincludestheLCD,keypadandcontrolknob,formstheuserinterfaceof

theMR200.

LCD Keypad

Control knob

Status indicator

Power switch

ExpressionMR200InstructionsforUseSystemOverview2‐11

Power Switch

Poweriscontrolledbythepowerswitch:

•PressthepowerswitchtoturnontheMR200.

•PressandholdthepowerswitchforapproximatelytwosecondstoturnofftheMR200.

Keypad

Thekeypadhaseightkeysforquickaccesstofrequentlyusedfunctions.

Key Function

Silence

Controls the alarm sound; see page 9-7 for details.

Suspend

Enters suspend mode; see page 2-19 for details.

NiBP

Begins a new NiBP measurement if no reading is in progress, or ends a

current measurement; see chapter 4.

Patient

Selects the type of patient to be monitored; see page 3-10 for details.

Trends

Accesses the HISTORY menu when in normal mode (see page 2-18) and

an individual graphic trend when a vital sign box is highlighted (see chapter

10).

Print

Initiates a 30 second print when using an equipped IP5.

Setup

Accesses the SETUP menu; see page 3-2 for details.

Main

Closes any menu and returns to the normal operating mode (see page 2-18)

2‐12SystemOverviewExpressionMR200InstructionsforUse

Control Knob

Thecontrolknoballowsyoutonavigateandselectoptions,itemsandsettingsinthemenu

system:

•Rotatingthecontrolknobclockwisemovesthe“cursor”downandrotatingtheknob

counterclockwisemovesthe“cursor”up.

•Inthenormalmode,rotatetheknobtohighlightdifferentvitalsignboxesandpressthe

knobtoopentheassociatedmenu.

•Whenamenuisdisplayed,rotatetheknobtohighlightoptionsanditemsandpressthe

knobtoselectthatoptionoritem.

•Whenaoptionisdisplayed,rotatetheknobtohighlightsettingsanditems,andpressthe

knobtoselectthatsettingoritem.

NOTE

In the menu system, grayed out panes, options labelled UNUSED or THIS ITEM IS LOCKED

when selected, reflect features or options that are inaccessible, not configured, or not installed.

Status Indicator

Thestatusindicatorisamulti‐colorLEDthatdenotesthepowerconditionofthecart,asdetailed

inthetablebelow.

Indicator Power Status

Color State Definition Power Switch

None Not

applicable

Not on external power (batteries may be

installed)

Off

Green Flashing AC power connected (batteries may be

installed)

Off

Green Solid On AC power (batteries, if installed, are

charging)

On

Yellow Solid On battery power On

Red Solid On battery power with a low battery condition

WARNING

A solid red light indicates battery

power has fallen below the required

limit and system shutdown with loss

of monitoring will occur. Immediately locate

an AC outlet and connect the MR200.

On

ExpressionMR200InstructionsforUseSystemOverview2‐13

LCD

Thedisplaypanelfeaturesacolorliquidcrystaldisplay(LCD).Alwaysadjustthecartsothatyour

viewoftheLCDcomplementsyourlineofsight.

CAUTION

Never apply unnecessary force to the LCD as it can result in screen damage or failure.

NOTE

To change the language displayed by the MR200, see page 11-16.

Display Areas

Fourdataareasaredisplayedinthenormaloperatingmode(seepage2‐18fordetails):

• Informationalarea(1,below)

•Vitalsignboxesarea(2,below)

• Communicationandpowerstatusdisplayarea(3,below)

•Vitalsigntracesarea(4,below)

NOTE

If a parameter (or an ECG trace) has been turned off, its portion of the LCD will be blank. To turn

a parameter on or off, use the PARAMETER SELECTION menu; see page 3- 7 for details.

1

2

3

4

2‐14SystemOverviewExpressionMR200InstructionsforUse

Informational Area

Theinformationalarea,alongthetopofthescreen,providesuserandpatientinformation:

•Timeprovidescurrenttime,givenina12‐or24‐hourformat(hh:mm:ss);seeSetTimeon

page3‐12fordetails.

•Symbolareaprovidesindicationsofthealarmsoundsetting,configurationstatus,and

heartbeatandrespirationdetection.

–Theindicatesanactivealarmsoundsetting,displayedatalltimes(unless

temporarilyobscuredbyamenuordialogbox);seechapter9.

–Whenenabled,theindicatesheartbeatdetection,flashingforeachdetected

pulse;seeHRTONESOURCEonpage3‐9.

–WhenCO2isonandwithinspecifiedlimits,theindicatesrespirationdetection,

flashingatafrequencythatmatchesthecurrentbreathrate;seechapter7.

•Patientdisplaystheselectedpatienttype;seepage3‐10.

•Currentsetupnamedisplaysthepower‐ondefault(seepage3‐13)orthememoryblock

thatwasused(seepage3‐4)forthecurrentsetupofthemonitor,wheretheplussymbol

(+)indicatesasettingchangehastakenplace;seeSynchronizationonpage2‐2.

•Notificationareadisplaysuptotwoinformational,statusand/ortechnicalmessagesata

time;and,ifthreeormoreexist,themessageswillcycle.

(Twomessagesareshownintheexampleabove;seeListingofAlarmsonpage9‐16

formessagesanddetails.)

Vital Sign Boxes Area

Thevitalsign(VS)boxesarea,alongtherightsideandthelowerportionofthescreen,contains

individualpanesthatprovidevitalsignnumericdata,alarmlimitsettingsandviolationindictions,

trendarrowindications,andmenuaccessforeachoftheparameters.

Time Symbol area

Notification area

Patient

Current setup name

ExpressionMR200InstructionsforUseSystemOverview2‐15

No Data Available Indication

UndercertainconditionsoneormoreofthenumericsintheVSboxesmaydisplaythreedashes

(‐‐‐)toindicatethatnodataisavailable.

ECG VS box (see page 4-16)

SPO2 VS box (see page 5-7)

NiBP VS box (see page 6-7)

CO2 VS box (see page 7-6)

RESP VS box (see page 8-3)

2‐16SystemOverviewExpressionMR200InstructionsforUse

Dependinguponthenatureofthisindication,analarmmaybegeneratedifnoparameterdatais

available.Inthiscase,thedasheswillbedisplayedinredandanalarmwillsound.

Analarmisgeneratedwhen:

• Parameterdatawaspresentbutisnolongeravailable(forexample,asensorthatwas

appliedmaynolongerbeconnectedtothepatient).

•Thehardwareassociatedwithaparameterhasexperiencedaproblemorfailurethat

preventsproperoperation.

Noalarmisgeneratedwhen:

•Amoduleoranothermeasurementdevicewasjustturnedonorappliedtothepatient

(allowafewsecondsforcommunicationtobeestablished).

•Thefirstreadinghasnotyetbeentakenortheparameterisinastart‐upcondition.

•Themeasurementvaluesaredistortedorthesignalisinadequate.

• Suspendmodewasjustexited.

Communication and Power Status Display Area

Thecommunicationandpowerstatusdisplayarea,alongthebottomofthescreen,provides

indicationsofthesystemnetworksetting,printingstatus,andthecommunicationandpower

statusofthecartandthewirelessmodules:

•PrintingstatusicondisplaysthestatusoftheIP5printer,whenequipped:

–Whenreadytoprint,isdisplayed.

–Whenprinting,isdisplayed,indicatingthetimeremaining(inseconds)

untilcompletion.

–Whennotinstalledorifacommunicationproblemexists,isdisplayed.

–Whenavailablebutunabletoprint,isdisplayed.

•Cartstatusiconindicatesthepowerstatusofthecart:

–WhereindicatesthecarthasbatteriesinstalledandisoperatingonAC

power.

–WhereindicatesthecarthasnobatteriesinstalledandisoperatingonAC

power.

Cart

status icon

Printing

status icon

wECG module

status icon

Network

icon

wSPO2 module

status icon

ExpressionMR200InstructionsforUseSystemOverview2‐17

–Whenonbatterypower,thebatterylevelwithatimeremainingcounterisdisplayed;

and,iflessthan45minutesofoperatingtimeremain,thenisdisplayedand

analarmissounded.

NOTE

After the start of battery power mode, the time remaining counter may take several minutes to

stabilize.

•wSPO2modulestatusiconindicatesthecommunicationandbatterystatusofthewSPO2

module:

–Whereindicatesthebatterylevel(withatimeremainingcounter,formatted

inhours:minutes).Iflessthan45minutesofoperatingtimeremain,thentheicon

turnsred,flashes,andanalarmissounded.

–Whereindicatesthereisnocommunicationbetweenthecartandmodule.

•wECGmodulestatusiconindicatesthecommunicationandbatterystatusofthewECG

module:

–Whereindicatesthebatterylevel(withatimeremainingcounter,formatted

inhours:minutes).Iflessthan45minutesofoperatingtimeremain,thentheicon

turnsred,flashes,andanalarmissounded.

–Whereindicatesthereisnocommunicationbetweenthecartandmodule.

•Networkiconindicates

thecurrentwirelessnetwork

channel

oftheMR200.Fivenetwork

channelsare

available(A–E),asshownbelow.Thischannelsettingcanbechangedtomeet

theneedsofyourfacilityandoperatingenvironment,butyoumustalsochangethesetting

ofthewirelessmodules(andIP5,ifequipped)tomatchthenew

MR200

channelforproper

systemcommunications

;seepage3‐15.



WARNINGS

• Care should be taken to guard against inadvertent changes to the network setting.

Before use, always ensure that all devices are communicating properly. Failure to do

so may cause a lapse in patient monitoring.

• In environments where multiple MR200s are being used, you must be aware of each

system’s network setting. Operating multiple MR200s 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.

Network

channel A

Network

channel B

Network

channel C

Network

channel D

Network

channel E

2‐18SystemOverviewExpressionMR200InstructionsforUse

Vital Sign Traces Area

Thevitalsigntracesarea,inthemiddleofthescreen,providesvitalsign(VS)waveformsand

systemstatusmessages.Tracewaveforms(A–D)areuniquelycoloredtomatchtheir

correspondingVSbox,andarefixedacrosstheLCDandupdatedwithanerasebar:

•TraceAisassignedanddisplayeddependingupontheECGmenuoptions;seepage4‐16.

•TraceBdisplaysECG2whentwoECGsourcesareon.

•TraceCdisplaystheSPO2waveform;seepage5‐7.

•TraceDdisplaystheCO2waveform;seepage7‐6.

•Systemmessageareaprovidessystemmessages,asdetailedthroughoutthismanualand

inListingofAlarmsonpage9‐16.

Modes of Operation

TheMR200hasthreedifferentoperatingmodes.

Normal Mode

Normalmodeisthestandardoperatingmode.Innormalmodetherearenoopenmenusor

highlightedvitalsignboxes;thesystemisreadyformonitoring.

Toenternormalmode

PresstheMainkey.

AnyopenmenuwillcloseandanyhighlightedVSboxwillbedeselected(thenormalscreenwillbe

displayed;seepage2‐13).

System message area

Trace A

Trace B

Trace C

Trace D

ExpressionMR200InstructionsforUseSystemOverview2‐19

Suspend Mode

Suspendmodesupportspatient‐clinicianinteractionwithoutnuisancealarms,whichisuseful

whereminimaluserinteractionisrequired(forexample,whileapatientisnotbeingmonitored,

duringtransitionswhenremovingthemonitorfromonepatientandconnectingitonanother,or

ifcertainadjustmentsarebeingmadetothedeviceorotherequipment).Insuspendmode,

currentpatientinformationisprovided,butwiththefollowingoperationalexceptions:

•Audiblealarmsaredisabled;

•ActiveautomaticNiBPmeasurementsaresuspended;

•DefaultinflationpressuresareusedforallmanualNiBPreadings;and,

•Automaticprintoutswillnotbegenerated.

Toentersuspendmode

PresstheSuspendkey.

SUSPENDEDwillbedisplayed(inred,nearthecenterofthescreen).

Toexitsuspendmode

PresstheSuspendkey.

Simulation Mode

Simulationmodesupportstrainingandtestingfunctionsbydisplayinginternally‐generateddata

forvitalsignwaveforms,numericsandstatuses.Insimulationmode,allpatientmonitoringis

discontinued.Forsimulationmodedetails,seepage11‐14.

2‐20SystemOverviewExpressionMR200InstructionsforUse

ExpressionMR200InstructionsforUseGettingStarted3‐1

CHAPTER 3

Getting Started

Initialsetupisimportanttoachieveexpectedresultsandseamlessoperation.Setupmenus

providetheabilitytoselectmonitoringoptions,controlfunctions,storeandrecalloperating

configurationsandaccesstestroutines.

CAUTIONS

• A minor but noticeable degradation in wireless module communications may occur in the

presence of high-powered radios.

• Prior to clinical use, the user must be aware of the minimum distance from the MR magnet

that must be maintained for proper operation; see Positioning the MR200 on page 2-6 for

details.

Monitor Initialization

Afterpower‐up,theMR200typicallytakesafewsecondstoinitialize.Duringthisperiod,theLCD

mayremainblankuntiltheprocesscompletes.TheMR200canbeginmonitoringfunctionsfrom

aninitialfactorydefaultstateorfromapre‐configuredstate,dependinguponthewaythestored

configurationsandpatientdataareprogrammedforstartup.

Visuallycheckingthepatientandconfirmingchangingmeasurementsagainstothervitalsigns

shouldbestandardroutinesduringuse.

Warning

WARNING

When using an IP5, make sure that the content of the RECALL SETUPS option matches

that of the MR200 option, and that the same option is selected as the default setup on both

systems (see page 3-4). This is important because the device first booted will determine the

power-on settings of the system (that is, the MR200 and IP5).

Initial Alarm Setting Indication

Afterpower‐upandimmediatelyfollowingtherecallofastoredsetup,theMR200providesan

initialindicationofthealarmvolumebysoundingthetoneatitscurrentsettingfor5seconds.

Duringthisinterval,CHECKALARMVOLwillbedisplayed.

AlarmHoldistheinitialstateofthealarmfunctionsfollowingpower‐up,andthenafterthewait

period(120seconds)Armedbecomesthenormalstate.IntheArmedstate,thealarmfunctions

3‐2GettingStartedExpressionMR200InstructionsforUse

operateasfollows:

•Thealarmtonewillsoundwhileanalarmconditionexists,providedthatanypre‐alarm

sounddelayhasexpiredandthesymbolisdisplayed.

•Messagesrelatedtootheralarmsoundstateswillberemovedfromthedisplay.

•Analarmconditionnotpreviouslyplacedinasilencedstatewillcausethealarmtosound

(providedthatanypre‐alarmsounddelayhasexpired).

SETUP Menu

FromtheSETUPmenu,youcanconfiguretheMR200tomeetyourpatientmonitoringneeds:

– Individualsetupconfigurationscanbesavedandrecalled.

– Availableparameterscanbeturnedonandoff.

–Patienttypecanbeselected.

– Soundscanbeadjusted.

–Dateandtimecanbeset.

– Networkdesignationcanbeset.

– Sweepandrespirationspeedscanbeselected.

–Defaultconfigurationforstart‐upcanbeselected.

–Alarmlimitscanbeset.

– Remoteprinterfunctionscanbeselected.

Warning

WARNING

When using an IP5, wait at least 4 seconds if performing a recall or setting a parameter

value, as these require a few seconds to propagate through the system. Performing another

recall within 4 seconds of a previous recall or after a value change, may result in improperly

recalled data.

TheSETUPmenuaccessesmenusforsetupandcontroloftheMR200.

ToentertheSETUPmenu

PresstheSetupkey.

ThefollowingoptionsareavailableintheSETUPmenu:

•ALARMSETUP(seechapter9fordetails)

ExpressionMR200InstructionsforUseGettingStarted3‐3

MONITOR Menu

TheMONITORSETUPoption(intheSETUPmenu)openstheMONITORmenu,whichcontains

optionsforsetupandcontrolofpatientmonitoring.

.

TochangesettingsintheMONITORmenu

• MONITORSETUP(seebelow)

•PRINTERSETUP(seechapter10fordetails)

Setup key

Control knob

MONITOR

menu

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

3‐4GettingStartedExpressionMR200InstructionsforUse

RECALL SETUPS

Restoresthemonitortoaparticularsetupthatwaspreviouslysaved(seeSTORESETUPSonpage

3‐5forconfigurationdetails,andseeDEFAULTSETUPSonpage3‐13forthepower‐onsetting.)

NOTE

The name of the current setup is displayed in the top left corner of the screen (see page 2-14). If a

setup was changed, a plus symbol (+) will appear next to the setup name ( A–F, User or Factory).

Thefollowingmemoryblockchoicesareavailable:

•A

•B

•C

•D

3Turnthecontrolknobtoselectanyofthefollowingsystem‐wide

optionsandthenpresstheknob:

RECALLSETUPS

STORESETUPS

PARAMETERSELECTION

SOUNDADJUST

PATIENT

PEDIATRICECG

SETTIME

DEFAULTSETUPS

SWEEPSPEED

RESPSPEED

NETWORK

SERVICE(BIO‐MED)

Foroptionsinformation,seetheappropriatesectionsbelow.

4Turntheknobtothedesiredsettingandthenpresstheknob.

5Tochangeothersettings,repeatsteps3and4.

6PresstheMainkeytoclosethemenu.

Alternative:TurntheknobtoRETURNandthenpresstheknob,or

waitapproximately60seconds.

Step Action

ExpressionMR200InstructionsforUseGettingStarted3‐5

•E

•F

•USER(Factoryprogrammingwillberecalledifthisoptionisselectedbutwasnotpreviously

stored;seepage3‐5.)

Torecallasetupfrommemory

STORE SETUPS

Storesuptosevensetupsfordifferentprocedures,patienttypesorusers,whichcanthenbe

recalledwithouttheneedofextrasetup.Thesememoryblocksaremaintainedbyalonglife

batteryorstaticRAM,savingthedata,evenwhenpoweredoff.Storablesettingsinclude:

– Systemsetups

–Patienttype,alarmssettings,auto‐setcalculationpercentage,latchedorunlatchedand

soundlevel

–ECGselectedlead,scale,tracespeed,filtermode,magnetcontrol,QRStonecontroland

heartratesource

–SPO2size,averagingtimeandHRtonesource

–CO2size,grids,unitsandrespirationspeed

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

3TurnthecontrolknobtoRECALLSETUPSandthenpresstheknob:

TheRECALLSETUPSmenuappears.

4Turnthecontrolknobtoselectoneofthefollowingmemoryblocks

andthenpresstheknob:

A

B

C

D

E

F

USER

Theselectedmemoryblockisrecalledforthesettingsofthe

MR200.(Ifdisplayed,the“+”symbolisremoved.)

3‐6GettingStartedExpressionMR200InstructionsforUse

–NiBPmanualorautosettingandautomatictimeinterval

–Trendgraphtimebaseandscale

–Printcontrol,tracedelay,speedandselectedtraces

Thefollowingmemoryblockchoicesareavailable:

•A

•B

•C

•D

•E

•F

•USER

Tostoreasetupinmemory

Step Action

1ConfigurethesettingsandoptionsoftheMR200asdesired.

2PresstheSETUPkey.

TheSETUPmenuappears.

3TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

4TurnthecontrolknobtoSTORESETUPSandthenpresstheknob:

TheSTORESETUPSmenuappears.

5Turnthecontrolknobtoselectoneofthefollowingmemoryblocks

andthenpresstheknob:

A

B

C

D

E

F

USER

Theconfigurationisstoredintheselectedmemoryblock.(If

displayed,the“+”symbolisremoved.)

ExpressionMR200InstructionsforUseGettingStarted3‐7

PARAMETER SELECTION

Controlsmonitoringfunctions,asindicatedbytheabsenceorpresenceoftheVSboxforthe

parameter,exceptECG(seebelow).

Thefollowingchoicesareavailable:

•ECGallowselectrocardiogrammonitoring:

–ONturnsontheECGparameter.(Default)

–OFFturnsofftheECGparameter.HeartratewillremainintheVSboxallowingitto

bedisplayedfromanotherselectedsourceorifHRSOURCEissettoAUTOandECGis

inaLEADFAILcondition.

•NiBPallowsnon‐invasivebloodpressuremonitoring:

–ONturnsontheNiBPparameter.(Default)

–OFFturnsofftheNiBPparameter.

•SPO2allowsoxygensaturationofarterialbloodmonitoring:

–ONturnsontheSPO2parameter.(Default)

–OFFturnsofftheSPO2parameter.

•CO2allowsCO2andrespirationmonitoring(ifinstalled):

–ONturnsontheCO2andtheCO2‐derivedrespirationparameter.

–OFFturnsofftheCO2parameter.(Default)

•RESPallowsbellowsrespirationmonitoring:

–ONturnsonthebellows‐derivedrespirationparameter.

–OFFturnsofftherespirationparameter.(Default)

Tocontrolaparameter

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

3TurnthecontrolknobtoPARAMETERandpresstheknob.

ThePARAMETERmenuappears.

3‐8GettingStartedExpressionMR200InstructionsforUse

SOUND ADJUST

Warning

WARNING

The alarm sound can be turned off, as indicated by the symbol. Always ensure that the

alarm sound setting is appropriate for the monitoring environment and for each patient. The

alarm sound volume is adjustable for suitability to various clinical environments. When you

use the MR200, always ensure that the alarm sound can be heard above the ambient noise

level; otherwise, treatment of the patient could be delayed.

Controlsalarm,heartrateandkeypadtones,andthevolumesettingsforeach.

NOTE

While in this menu, tones generated during patient monitoring are disabled and REAL TONES

DISABLED will be displayed.

Thefollowingchoicesareavailable:

•ALARMScontrolsthealarmsound(identicaltoand

interactivewithALARMSOUND;seepage9‐12):

–ONturnsonthealarmsound,whereindicates

thatthesoundhasbeenenabled.(Default)

–OFFturnsoffthealarmsound,whereindicates

thatthesoundhasbeendisabled.(Onlythealarm

soundwillbedisabled;thevisualalertfromthesource

oftheviolationstillflashesinred.)

4Turnthecontrolknobtoselectoneofthefollowingparametersand

thenpresstheknob:

ECG

NiBP

SPO2

CO2(ifinstalled)

RESP

Theparameter’sactivationmenuappears.

5Turntheknobtothedesiredsettingandthenpresstheknob.

Step Action

ExpressionMR200InstructionsforUseGettingStarted3‐9

•HRTONESOURCEsetsthesourceusedfortheheartratetone(identicaltoandinteractive

withthesameoptionintheECGandSPO2menus):

–OFFremovestheheartsymbolfromthedisplayandproducesnotone.(Default)

–QRSprovidesatonemodulatedbytheQRSdetectionfromtheECGvitalsign.

–SPO2providesatonemodulatedbytheSPO2vitalsign,wherealowervalue

producesalowerpitch.

•ALARMVOLUMEsetsthealarmsoundlevelfrom1–10.(Default=4)

•PULSEVOLUMEsetsthepulsetonevolumefrom1–10.(Default=4)

•CLICKTONEcontrolsthekeypadtonegeneration.(Default=On)

•CLICKVOLUMEsetstheclicktonevolumefrom1–10.(Default=4)

Toadjustthesounds

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

3TurnthecontrolknobtoSOUNDADJUSTandpresstheknob.

TheSOUNDADJUSTmenuappears.

4Turnthecontrolknobtoselectoneofthefollowingmenusand

thenpresstheknob:

ALARMS

HRTONESOURCE

ALARMVOLUME

PULSEVOLUME

CLICKTONE

CLICKVOLUME

Theselectedmenuappears.

5Turntheknobtothedesiredsettingandthenpresstheknob.

Thesettingisenteredandabriefsoundatthecorrespondinglevel

isproduced.

3‐10GettingStartedExpressionMR200InstructionsforUse

PATIENT

Selectsthetypeofpatienttobemonitored.

DeterminingthePatientType

IEC80601‐2‐30Edition1.0,theinternationalstandardregardingparticularrequirementsfor

safety,includingessentialperformanceofautomaticcyclingnon‐invasivebloodpressure

monitoringequipment,definespatienttypesintwocategories:neonatalandadult.Neonatal

patientsaredefinedbytheapproximateagerangeofbirthtoafewweeks.Allotherpatientsare

identifiedasadults.

ANSI/AAMISP10:2008,theAmericanNationalStandardformanual,electronic,orautomated

sphygmomanometers,definespatienttypesaccordingtoagelimitations,asindicatedinthetable

below.

Similarly,theFood&DrugAdministrationdefinespatientswithintwocategories:pediatricsand

adults.Eachcategoryisfurtherdefinedintosubgroupsaccordingtoapproximateage.

CAUTION

There may be occasions when a particular mode is not suitable for its apparent category of patients

based on age alone. In these cases, a clinical decision shall be made to use another patient type or

measurement technique. The clinical decision shall be based on all of the factors listed in

Determining Patient Type (above) to ensure the best possible and most timely measurement

acquisitions.

Regardlessofthedefinition,eachagencyrecognizesthatthepatienttypedescriptionscanbe

arbitraryandthatthefollowingpatientfactorsaremoreaccurateindeterminingtheappropriate

methodofpatientmonitoringandtreatment:

–Weight

–Bodysize

Patient Type Age

Neonatal Birth to 28 days

Pediatric 29 days to 12 years

Adult Greater than 12 years

Patient Type Subgroup Approximate Age Range

Pediatric Newborn (neonate) Birth to 1 month

Pediatric Infant Greater than 1 month to 2 years

Pediatric Child Greater than 2 to 12 years

Pediatric Adolescent Greater than 12 to 21 years

Adult --- Greater than 21 years

ExpressionMR200InstructionsforUseGettingStarted3‐11

–Limbcircumference

– Physiologicaldevelopment

–Neurologicaldevelopment

– Neuromuscularcoordination

Accordingly,theMR200usesseveraloperationalparameters,includingcuffinflationpressure

andpulsesensitivity,thatvarydependingontheselectedpatienttype.(Alwaysreferto

informationaboutthecorrespondingparameterforotherpossibleconsiderationswhen

determiningthepatienttype.)

Thefollowingpatienttypesareavailable:

•ADULT(Default)

•PEDIATRIC

•NEO(whenselected,PEDIATRICECGisalwayson.)

NOTE

Changing the PATIENT type causes the alarm to sound, the PATIENT indication to be revised,

CHANGE NiBP CUFF to be displayed for 30 seconds, and the alarm limit settings to revert to

the default values (see the table on page 9-15 for details).

Toselectthepatienttype

PressthePatientkey.Turnthecontrolknobtothedesiredtypeandthenpresstheknob.

PEDIATRIC ECG

ProvidesadditionalECGfilteringwhenpatients,particularlypediatrics,presentwithnarrowQRS

complexesand/orhigh(120BPM)heartrates.

Thefollowingchoicesareavailable:

•OFFturnsthepediatricECGfilteroff.(Default)

•ONprocessesECGdatausingapediatricalgorithm,inadditiontothegradientfilter

setting,andoperatesunderthefollowingconditions:

–WhenanECGtraceisprinted,PEDECG=ONorPEDECG=OFFwillappearonthestrip.

–ThesettingwillbesavedduringSTORESETUPSandrecalledduringRECALLSETUPS.

3‐12GettingStartedExpressionMR200InstructionsforUse

NOTE

When PATIENT is set to NEO, PEDIATRIC ECG is set to ON and locked. When the PATIENT

type is changed to ADULT, PEDIATRIC ECG will be set to OFF and unlocked.

TocontrolthepediatricECGfilter

SET TIME

Setsthetimeanddate.Thetime,continuouslyoperating,isdisplayedonLCDandthedate

formatisMMMDD,YYYY(forexample,JAN01,2013).

Thefollowingchoicesareavailable:

•FORMATchangestheformatofthedisplayedtime

–12hour

–24hour(Default)

•SECONDsetsthesecond.

•MINUTEsetstheminute.

•HOURsetsthehour.

•DAYsetstheday.

Pediatric ECG Patient Type Condition

Off Adult Unlocked

On Pediatric Unlocked

On Neonatal Locked

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

3TurnthecontrolknobtoPEDIATRICECGandpresstheknob.

ThePEDIATRICECGmenuappears.

4Turnthecontrolknobtothedesiredsettingandthenpressthe

knob.

ExpressionMR200InstructionsforUseGettingStarted3‐13

•MONTHsetsthemonth.

•YEARsetstheyear.

•ENTERsavesanychanges.

Tosetthetimeanddate

DEFAULT SETUPS

SelectstheinitialsettingsusedwhenpowerisappliedtotheMR200.

Thefollowingchoicesareavailable:

•FACTORYusesthefactoryprogrammedsettings.(Default)

•USERusessettingsfromtheUSERmemoryblock;seeRECALLSETUPSonpage3‐4.

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

3TurnthecontrolknobtoSETTIMEandpresstheknob.

TheSETTIMEmenuappears.

4Turnthecontrolknobtoselectanyofthefollowingtimeoptions

andthenpresstheknob:

FORMAT

SECOND

MINUTE

HOUR

DAY

YEAR

Theselectedoptionappears.

5Turntheknobtothedesiredsettingandthenpresstheknob.

6Tochangeothersettings,repeatsteps4and5.

7TurnthecontrolknobtoENTERandthenpresstheknob.

Thechangesaresaved.

3‐14GettingStartedExpressionMR200InstructionsforUse

Tosetthedefaultsetups

SWEEP SPEED

ChangesthetracespeedofallwaveformsexceptCO2.

Thefollowingsweepspeedchoices(inmillimeterspersecond)areavailable:

•50mm/s

•25mm/s(Default)

Toadjustthesweeprate

SeeChangingtheWaveformSpeedonpage4‐17.

RESP SPEED

SetsthetracespeedoftheCO2waveform.

Thefollowingsweepspeedchoices(inmillimeterspersecond)areavailable:

•25mm/s

•12.5mm/s(Default)

•6.25mm/s

•3.125mm/s

•1.5625mm/s

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

3TurnthecontrolknobtoDEFAULTSETUPSandpresstheknob.

TheDEFAULTSETUPSmenuappears.

4Turnthecontrolknobtoselectoneofthefollowingoptionsand

thenpresstheknob:

FACTORY

USER

Thepower‐ondefaultisset.

ExpressionMR200InstructionsforUseGettingStarted3‐15

• 0.33333mm/s

ToadjustthesweeprateforCO2respiration

SeeChangingtheWaveformSpeedonpage7‐6.

NETWORK

Setsthewirelesscommunicationschannelforthecart.Thenetworkusedbythecartandthe

wirelessmodulesmustbethesame.

Thefollowingnetworkchoicesareavailable:

•A(Default)

•B

•C

•D

•E

Tosetthenetwork

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

3TurnthecontrolknobtoNETWORKandpresstheknob.

TheNETWORKmenuappears.

4Turnthecontrolknobtoselectoneofthefollowingoptionsand

thenpresstheknob:

A

B

C

D

E

TheMR200networkchannelisset.

5IfequippedwithanIP5,ensurethatthenetworkusedbythe

wirelessmodules(seepage1‐21)andtheIP5areidenticaltothe

selectionmadeinstep4.

3‐16GettingStartedExpressionMR200InstructionsforUse

SERVICE(BIO-MED)

Allowsaccesstopressureandmiscellaneousconfigurationsettings,diagnosticroutinesand

firmwareinformation;seepage11‐12fordetails.

ExpressionMR200InstructionsforUseMonitoringECG4‐1

CHAPTER 4

Monitoring ECG

Electrocardiogram(ECG)monitoringinsidetheMRIenvironmentisuniqueandrequires

additionalprecautionstopermitsafepatientprocedures.Itisalwaysimportanttoremember

thattheriskofradiofrequency(RF)heatingiseverpresentwhenanyelectricalconductors(for

example,ECGleadcables)areplacedintheMRsystembore.Byfollowingtheoperating

precautions,warningsandtheguidelinesbelow,theseriskscanbeminimized.TheECG

parameterisintendedforECGmonitoringmodeandnotdiagnosticECGmonitoring.

WARNINGS

•The MR200 is not intended for use with patients using pacemakers or electrical

stimulators.

• Arrhythmias, erratic heartbeats, operation of electrical stimulators, pacemakers and

patient motion can result in inaccurate readings. Rate meters may continue to count

pacemaker rates during occurrences of cardiac arrest or some arrhythmias. Do not

rely entirely upon rate meter alarms. If questionable readings are obtained, check the

patient's vital signs by alternate means before administering medication.

CAUTION

Pacer pulses are not specifically rejected by the MR200 and may be treated as part of MRI

gradient noise. Gradient filtering attempts to remove high frequency pulse shaped waveforms from

the ECG signal which may resemble pacer waveforms, and it is possible that the pacer waveform

may be removed with the gradient noise.

wECG Module and Lead Cable

ThewECGmoduleandleadcableareintendedforpatientuseswhencontinuousECGmonitoring

orcardiacgatingarerequired.ThewECGmoduleandleadcablemaybeusedintheMRsystem

bore,althoughthemodulemustnotbeplacedwithintheMRIfieldofview(FOV).

CAUTIONS

• If dropped, the wECG module must be verified for correct operation before use.

• Guard against the accidental ingress of liquid into the module, as measurements made by the

device can be adversely affected.

4‐2MonitoringECGExpressionMR200InstructionsforUse

NOTE

Refer to your facility's biohazard procedure for disposal of ECG lead cables when they become

unusable. Usually cables are disposed of as medical waste per facility procedures.

Defibrillator Use

TheMR200hasadefibrillation‐proofdegreeofprotectionthatallowsapatienttobe

defibrillatedwhileconnectedtothewECGmoduleandleads.Whenusingadefibrillator,follow

allprecautionsrelatedtoboththeMR200andthedefibrillatorequipment.Duringadefibrillation

procedure,theECGwaveformwillsaturatethenrecoverinlessthan5secondsinaccordance

withAAMI/ANSIEC13andIEC60601‐2‐27.

WARNINGS

•The patient connector inputs for all parameters are protected against the use of a

defibrillator by internal circuitry when the recommended patient cables or accessories

are used.

• Defibrillation and electrosurgery: Do not touch the patient, or table, or instruments,

during defibrillation.

• The MR200 can be used in the presence of defibrillators or electrosurgery units,

provided the equipment being used is in good working order, meeting appropriate

safety standards, is properly grounded and is operated correctly in the appropriate

manner and environment. Improperly grounded equipment can be a safety hazard

and can also cause interference to the ECG signal and result in a noisy ECG signal

waveform and inaccurate heart rate measurements.

CAUTION

When using a defibrillator, do not introduce discharges of 360 joules or more, repeated five times

over 5 minutes. Read the safety instructions provided with the defibrillator. The MR200 Cart is

designed to withstand defibrillation and will recover within 5 seconds (per IEC 60601-1,

Requirements for the Safety of Medical Electrical Equipment), and IEC 60601-2-49, Particular

requirements for the basic safety and essential performance of multifunction patient monitoring

equipment).

ExpressionMR200InstructionsforUseMonitoringECG4‐3

Patient Preparation for ECG Monitoring

WhenmonitoringECG,thesiteselectedonthepatient,theQuadtrodeelectrodeandECGlead

cable,thefilterandleadviewsettingofthemonitor,andtheambientenvironmentwillimpact

theperformanceandoperationoftheparameter.

ECG Site Considerations

MonitoringECGintheMRenvironmentisparticularlychallengingbecauseoftheinherent

distortionoftheECGwaveformcausedbytheMRmagneticfield.Thesebloodflowinduced

distortionsoftheECGareduetothelargeamountofbloodmovingthroughthevesselsofthe

heart(aorta).Blood(a verygoodelectricalconductor)movingthroughthelargemagneticfieldof

theMRproducesanelectricalpotentialthataddstotheECGsignal.Thisinducedelectrical

potentialisseenprimarilyasanaugmentationoftheECGT‐waveamplitude,althoughothernon‐

specificwaveformchangesarealsoapparentontheECG.SinceanelevatedT‐waveorST

segmentwillbeassociatedwithtruephysiologicdisorders,thestaticmagneticfield‐induced

ECG‐distortionswillbeproblematic.Forthisreason,abaselinerecordingoftheECGpriorto

placingthepatientinsidetheMRmagnetroomwillbenecessary.Theproperplacementofthe

ECGelectrodesintheMRIiscriticaltoreducingthebloodflowinduceddistortionoftheECG

waveform.WithproperstrategicplacementoftheECGelectrodesandminimizationofthelead

cablelength,thisbloodflowinduceddistortioncanbekepttoaminimum.Followingthe

instructionsprovidedonthespecificQuadtrodefoilpackagingwillminimizethebloodflow

induceddistortionontheECGsignal.Additionalartifactscausedbythestatic,gradientandRF

electromagneticfieldscanseverelydistorttheECG,makingobservationofthemorphologic

changesanddetectionofarrhythmiaquitedifficult.MonitoringadifferentECGlead(I,II,III,AVL,

AVR,AVF)willminimizesomeoftheseartifacts.

ECG Quadtrode Electrode Types

OnlyusespecifiedQuadtrodeelectrodeswiththeMR200asthiswillminimizethepossibleriskof

ECGelectrodeandcableheatingduringMRIprocedures,andreducetheamountofMRI‐

generatedartifactsontheECGwaveform.ThreeQuadtrodeelectrodetypesareavailabletomeet

thedifferentpatientandECGperformanceneeds:

•QuadtrodeMRIECGPAD(REF989803179031)forgeneralMRIproceduresforadultsand

pediatricpatientsweighingmorethan10kg(22pounds).

•ELCTRD,MRIECG,CV(REF989803179041)forcardiovascular(CV)MRIprocedures.

•ELCTRD,MRI,NEO(REF989803179051)forgeneralMRIproceduresforinfantsand

neonatalpatientsweighinglessthan10kg(22pounds).

4‐4MonitoringECGExpressionMR200InstructionsforUse

Selecting the Quadtrode Electrode and ECG Lead Cable

ECGleadcablesarespeciallyconstructedtoavoidpatientheatingbyreducingtheamountof

radiofrequency(RF)energythatcanflowthroughthewires.Suggestedapplicationsandthe

recommendedleadcable(forpartnumbers,seepage1‐26)andelectrodepairingsareprovided

below.

Selecting the Quadtrode Electrode Placement Site

Foroptimalperformance,usetheillustrationsbelowasplacementguidelineswhenapplyingthe

Quadtrodeelectrodetothepatient.

NOTE

In the illustrations below, an imaginary nipple line is denoted by the horizontal axis.

Cable,4LD,MRIECGwithQuadtrodeelectrode(REF989803179031):

–Forallpatientsweighingover22pounds(10kg)

–Usewithallscansexceptcardiovascularscans

Cable,4LD,CVMRIECGwithQuadtrodeelectrode(REF989803179041):

–ProvidesthebestECGperformanceforallprocedures

–Worksbestonfemalesandoverweightpatients

Cable,4LD,NEO.MRIECGwithQuadtrodeelectrode(REF989803179051):

–Designedforinfantsandneonatesweighingunder22pounds(10kg)

–Forsedationandgeneralanesthesiaapplications

Cable,AdvancedFilterECGwithQuadtrodeelectrode(REF989803179041):

–DesignedtominimizethegradientartifactontheECGtrace

Cable,AdvancedAppsECGwithQuadtrodeelectrode(REF989803179041):

–Designedtoallowforwideelectrodeplacement

ExpressionMR200InstructionsforUseMonitoringECG4‐5

Selectingsitesonadultfemalepatients

Selectingsitesonadultmalepatients

Averageweightadultfemale Overweightadultfemale

CVQuadtrode(preferred)CVQuadtrode(preferred)

StandardQuadtrodeStandardQuadtrode

Averageweightadultmale Overweightadultmale

CVQuadtrode(preferred)CVQuadtrode(preferred)

StandardQuadtrodeStandardQuadtrode

4‐6MonitoringECGExpressionMR200InstructionsforUse

Selectingsitesonpediatricpatients

Selectingsitesoninfantsandneonatalpatients

*Forpatientsweighinglessthan22pounds(10kg)

Pediatricfemale Pediatricmale

CVQuadtrode(preferred)CVQuadtrode(preferred)

StandardQuadtrodeStandardQuadtrode

InfantsandNeonates

StandardQuadtrode NeonatalQuadtrode*

ExpressionMR200InstructionsforUseMonitoringECG4‐7

Preparing the ECG Site

Toprepareanelectrodesiteonapatient

NOTES

• The ECG Skin Prep gel contains light abrasive pumice and saline that clean and enhance

the conductive properties of the skin, thus enhancing ECG performance. This practice also

helps remove ambient artifacts, such as the 50/60 hertz noise generated by the MR

environment.

• Isopropyl/rubbing alcohol must not be used to prep the site as it breaks down the conductive

properties of the skin, thus degrading ECG performance.

Checking Electrode Contact Quality

ProperQuadtrodeelectrodepreparationiscriticaltoECGperformance.Theresultofpoor

electrodepreparationwillbepoorECGmonitoringperformance.Ifelectrodecontactispoor,

thenremoveanddiscardtheelectrode,andrepeatthesitepreparationprocessaccordingtothe

instructionsabove.Neverreuseanelectrodeasitsadhesivewillnotsecurelyfastentotheskin.

Step Action

1ChecktheexpirationdateoftheQuadtrodeelectrodepackage.

2Ifnecessary,shavetheapplicationareatoremovehairfromthe

selectedelectrodesite(s).

3ApplyECGSkinPrepGel(REF989803152291)toagauzepad.

4Brisklyrubtheselectedsite(s)withthegauzepad(theskinmay

turnpink).

5 Removeanyexcessgelwithacleangauzepad.

6 FollowtheplacementinstructionsprovidedoneachQuadtrode

package.(Alsoreferencetheillustrationsabove.)

4‐8MonitoringECGExpressionMR200InstructionsforUse

Attaching the Lead Cable

Designatorsontheleadcablereferenceplacesonthetorsowheretheelectrodesshouldreside

inrelationtothepatient’sextremities.However,dependinguponthecabletype(IECorAHA),

therespectivecablesusedifferentdesignatorsandcolorstoreferenceleadplacement.

WARNINGS

• Never use any ECG lead cables other than the specified ECG lead cables.

• High levels of RF energy may cause patient heating or burns.

• Lead cables that become inadvertently looped during an MRI examination may act as

conductive lines for RF induced currents, resulting in excessive heating and possible

burns. When lead cables or other cables form a conductive loop in contact with the

patient's tissue, minor to severe burning can result. Please refer to the additional

information in Appendix D to prevent excessive heating associated with MRI

procedures. Follow steps to minimize the risks of MRI-related heating on page 4-12.

TheconnectiondiagramsbelowillustrateplacementofeachtypeofECGleadcable.

CAUTION

ECG clip leads should not be placed on the patient’s extremities.

Limb AHA Lead Designator, Color IEC Lead Designator, Color

Right arm RA, White R, Red

Right leg RL, Green N, Black

Left arm LA, Black L, Yellow

Left leg LL, Red F, Green

AHA Lead Cable Connections IEC Lead Cable Connections



ExpressionMR200InstructionsforUseMonitoringECG4‐9

ToattachtheleadcabletothewECGmoduleandleadcableclipstotheQuadtrodeelectrode

Step Action

1Alignthecolorcodingonthe

leadcableconnector(A)

withcolorcodingonthe

wECGmodule(B)then

inserttheconnectorintothe

module.(AnAHAleadcable

isshownintheexample.)

CAUTION

When inserting or removing the lead cable or clip leads, only use the

connector or clip; never pull or apply excessive force to the wires.

2 DependinguponthetypeoftheECGleadcableandreferencingthe

diagramsonpage4‐8,attachtheECGclipleadstotheQuatrode

electrode.

3 Keepthemoduleoutsidethefieldofview(FOV)byplacingitinone

ofthetwolocationsshowninPositioningthewECGModuleand

LeadCableforScanningonpage4‐11.

4Checkthestatusindicatorofthemodule;seepage2‐8:

• Solidgreen=Batterypowergood/Goodcommunication

• Flashinggreen=Batterypowergood/Nocommunication

• Solidred=Lowbatterypower/Goodcommunication

• Flashingred=Lowbatterypower/Nocommunication

A

B

IEC lead cable

F

LR

N

RL

RA LA

LL

AHA lead cable

4‐10MonitoringECGExpressionMR200InstructionsforUse

Lead Failure Indication

IfadisconnectedorfaultyQuadtrodeelectrodeorECGleadisdetectedduringmonitoring,the

systemwillimmediatelynotifyyousothatquickactioncanbetakentoidentifythesourceofthe

failureandproceedwithaninformedresponse.Asshownintheexamplebelow,LEADFAILwill

bedisplayedandaredLeadFailindicatorwillappearintheECGVSboxidentifyingthespecific

location(LL,LA,orRA);seepage9‐18fortroubleshootinginformation.

Warning

WARNING

Failure to respond to a Lead Fail alarm will result in a lapse of patient monitoring.

NOTE

If the RL electrode has lost contact (or if all electrodes have lost contact) then LL, LA, RA will be

the displayed indication.

LEAD FAIL indicator

(Example, left arm)

LEAD FAIL message

ExpressionMR200InstructionsforUseMonitoringECG4‐11

Positioning the wECG Module and Lead Cable for Scanning

WARNINGS

• When applying electrodes or connecting the patient lead cable, ensure that the

electrodes or connectors never contact other conductive materials including grounded

conductors. In order to prevent contact with other conductors or earth ground, make

sure all the electrodes or connectors are properly attached to the patient.

• No other electrical conductors (e.g. wires, leads, probes, etc.) should be placed within

the MRI bore at the same time as the ECG lead wires. Electrode heating risk increases

when multiple conductive cables and sensors are placed in the bore with the patient.

Mixing of conductors from various manufacturers (catheters, temperature sensors,

etc.) is not recommended. Multiple electrical conductors within the MRI bore can

allow cross-coupling between these various conductors, and appear as a large antenna

for RF energy pick-up, which will result in electrode heating, and possibly skin burns.

It is always important to identify if the patient has any metallic wires, conductors,

implants, stents, etc. within their body which will act as cross-coupling conductors. If

these are present, ECG monitoring may not be able to be performed without

experiencing electrode heating. Non-conductive tubes, air-lines, etc.—including NiBP

cuffs and hoses, EtCO2 and/or oxygen air-lines, and SPO2 sensors—can be used safely

as these items do not include electrically conductive materials. The MR200 has been

validated for use with all accessories specified in the accessory list.

• Circular, U-shaped or S-shaped loops in the patient lead cable should be avoided to

reduce the risk of heating.

ThewECGmodulemaybeusedintheMRsystembore,althoughthemodulemustnotbeplaced

withintheMRIfieldofview(FOV).

LeadcablesmustalwaysbekeptinastraightlineandmustnottouchtheMRsystembore.Any

loop(circular,U‐shaped,S‐shaped)inthecablesorcablecontactwiththeMRsystemborewill

causeheatinginthecablesorinthepatientelectrodes.Followthestepsbelowtominimizethe

cableheatingrisk.

4‐12MonitoringECGExpressionMR200InstructionsforUse

NOTE

Follow these guidelines to ensure the best possible performance of the wECG module, especially

during harsh scan sequences (with PNS-peripheral nerve stimulation-levels above 80 percent):

1. Place the modules on or near the patient as close to the bore iso-center as possible

(considering the scan to be performed).

2. Keep the wireless module outside the field of view.

3. Place the modules as close to the bore opening as possible. (If the modules can be placed

outside the bore, positioning at the bore iso-center is not necessary.)

4. Place the modules on a cushioned surface to minimize MR vibrations.

Warning

WARNING

If the wECG module is positioned incorrectly when used within the MR magnet room, the

following factors may cause ECG waveform distortion and numeric inaccuracies:

• Fast magnetic field changes usually found with, but not limited to, scan sequences

using Peripheral Nerve Stimulation (PNS) levels above 80 percent.

• Severe vibrations induced by scan sequences using PNS levels above 80 percent.

• The distance from the bore iso-center in the x, y, or z directions.

Minimizing the Risk of MRI-Related Heating

CAUTION

Placing the wECG module within the FOV may interrupt ECG monitoring during the MRI

procedure and cause MRI image artifacts.

TominimizetheriskofMRI‐relatedheating

Step Action

1ArrangetheECGleadcableandtheclipleadsneatly,inastraight

alignment,withnolooping.

2Avoidcontactbetweencablesandbareskin.

3UseonlytheECGleadcablesdesignatedforusewiththisproduct;

seepage1‐26.

4 Minimizetheuseofmultiplecables.(Seethewarningsonpage4‐

11fordetails.)

ExpressionMR200InstructionsforUseMonitoringECG4‐13

Checking the ECG Signal Strength

Aminimumsignalstrength(amplitude)shouldbepresent,assmallersignalsmaybeproneto

gradientinterference.EvaluatetheECGsignalproducedbythepatientbeforeentryintotheMRI

scanner,theoptimumtimetocorrectanyproblem.

AproperECGsignalisdeterminedbythepeak‐to‐peakamplitudeoftheQRScomplex.TheQRS

complexshouldbeapproximately2millivoltsonthedisplay(thatis,thesignalshouldbetwice

thesizeofthescaleindicator,a1mVreference,atanygivenSCALEsetting).

Selecting the Scale

TheSCALEsettingonlychangeshowtheECGtraceappearsonthescreen,increasingor

decreasingthewaveformandanyartifacts.ToincreasetheamplitudeoftheQRSComplex,see

ChangingtheLeadViewonpage4‐14.

5ThewECGmodule,ECGleadcablesandQuadtrodeelectrodeare

acceptableforusewithinMRsystemswithstaticmagneticfield

strengthsof3.0TeslaorlesswithintheMRsystemboreusingaMR

systemreportedwholebodyaverageSpecificAbsorptionRates

(SAR)upto4.0W/kg.

6 MonitoringofECGatpowerlevelsofgreaterthanaMRsystem

reported,wholebodyaveragedSARof4W/kgisnotrecommended

forthegeneralpatientpopulation.Suchmonitoringmustonlybe

attemptedwithconsciouspatientswithnormalthermoregulatory

capabilitiessothattheymaywarnyouofpossibleexcessiveheatat

themonitoringsites.

7Usecautionforscantimes(thatis,perpulsesequence)greater

than15minutes.ForMRIscanswithaverageSAR>1W/kg,limit

scantimeto15minutesandpauseatleast3minutesbetween

scanstoallowtheECGelectrodestocool.

8Duringmeasurement,checkthepatienttoensurethatMRI‐related

heatingisnotoccurring.

Step Action

Scale indicator

QRS complex

4‐14MonitoringECGExpressionMR200InstructionsforUse

TochangetheSCALEsetting

Changing the Lead View

IftheQRSComplexdoesnotequalaminimumof2mV,thencompletethefollowingsteps.

Tochangetheleadview

Step Action

1PressthePatientkeyandthenselecttheappropriate

PATIENTtype;seepage3‐10fordetails.

2

TurnthecontrolknobtohighlighttheECGVSbox(seepage4‐18)

andthenpresstheknob.

TheECGmenuappears.Currentsettingsaredisplayed.

3TurnthecontrolknobtoSCALEandthenpresstheknob.

TheSCALEmenuappears;seepage4‐21.

4Turntheknobtoselectthesettingandthenpresstheknob.Onlya

settingof5mm/mVor10mm/mVisrecommended.

AUTO

1mm/mV

5mm/mV

10mm/mV

15mm/mV

20mm/mV

25mm/mV

30mm/mV

40mm/mV

Thesettingisapplied.

5Takenoteofthescaleindicator;seepage4‐16.Iftheselectedscale

resultsinanECGtracesolargethatthewaveformpeaksare

distortedorclipped,OVERSCALEwillbedisplayed.Inthiscase,

selectanothersettingtoresizethewaveformuntilthemessage

stops.

Step Action

1VerifytheQuadtrodeelectrodedate,qualityandpackaging.

2EnsurethatthepreferredQuadtrodeelectrodeandplacement

site(s)arebeingused;seepage4‐4.

ExpressionMR200InstructionsforUseMonitoringECG4‐15

Selecting the Filter Mode

ChoosetheappropriateECGfiltermodeforyourMRIstudy.

Tochangethefiltermodesetting

3TurnthecontrolknobtohighlighttheECGVSbox(seepage4‐18)

andthenpresstheknob.

TheECGmenuappears.Currentsettingsaredisplayed.

4 Dependinguponthetracebeingexamined,turnthecontrolknobto

TRACEALEADorTRACEBLEADandthenpresstheknob.

Therespectivemenuappears;seepage4‐20or4‐20.

5Changethesettingtoadifferentleadviewtoaccountforpatient

variabilityandthenpresstheknob.

I

II

III

AVL

AVR

AVF

Theleadviewchanges;seepage4‐16.

NOTE

When presented with a low QRS amplitude from ECG or poor

gating, it may be necessary to use the PEDIATRIC ECG setting;

see page 3-11.

6Iftheamplitudedidnotimprove,cyclethroughtheremaininglead

viewstoafindthebestsignalamplitudebyrepeatingstep5.

7Iftheamplitudedoesnotimprove,removetheleadcableand

Quadtrodeelectrodeandthenpreptheapplicationsiteagain.

Step Action

1TurnthecontrolknobtohighlighttheECGVSbox(seepage4‐18)

andthenpresstheknob.

TheECGmenuappears.Currentsettingsaredisplayed.

2TurnthecontrolknobtoFILTERMODEandthenpresstheknob.

TheFILTERMODEmenuappears;seepage4‐23.

4‐16MonitoringECGExpressionMR200InstructionsforUse

ECG Waveforms and VS Box

TheelementscontainedinthedisplayedECGwaveform(TraceA,andBifenabled)andVSbox

aredescribedbelow:

3Turntheknobtoselectthefilterandthenpresstheknob.

MONITOR

PRIMARY

SECONDARY

CARDIAC

ADVANCED

Thesettingisapplied,asindicatedabovetheECGVSbox.

Step Action

Definition

1 Is the high limit setting of the HR (heart rate) alarm; see page 4-19

2 Is the heart rate measurement (numeric)

3 Is the low limit setting of the HR alarm; see page 4-19

4 Is the unit of measure for the heart rate, where BPM is beats per minute

5 Is the selected HR SOURCE; see page 4-22

6 Is the name of the vital sign

7 Is the detected ECG Trace B waveform

8 Is the scale indicator, a 1-millivolt signal reference (see SCALE on page 4-21)

9 Is the selected TRACE B LEAD; see page 4-20

10 Same as 8, above

11 Is the selected TRACE A LEAD; see page 4-20

12 Displays LEAD FAIL when detected; see the example on page 4-10

1

2

3

6

8

9

7

10

5

11

12 13 14 15

4

ExpressionMR200InstructionsforUseMonitoringECG4‐17

Changing the Waveform Speed

TochangetheECG(andSPO2)waveformspeed

Changing the Heart Rate Alarm Limits

Tochangetheheartratealarmlimitsettings

13 Is the detected ECG Trace A waveform

14 Displays messages; see page 9-16 for details

15 Is the selected FILTER MODE; see page 4-23

Definition

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

3TurntheknobtoSWEEPSPEEDandthenpresstheknob.

TheSWEEPSPEEDmenuappears;seepage3‐14.

4Turnthecontrolknobtoselecteitherofthefollowingsettingsand

thenpresstheknob:

50mm/s

25mm/s

Theselectionisentered.

Step Action

1TurnthecontrolknobtohighlighttheECGVSbox(seepage4‐18)

andthenpresstheknob.

TheECGmenuappears.Currentsettingsaredisplayed.

2TurnthecontrolknobtoALARMLIMITSandthenpresstheknob.

TheALARMLIMITSmenuappears.Currentsettingsaredisplayed;

seepage4‐19fordetails.

3Turntheknobtothel

oworhigh

settingandthenpresstheknob.

Thesettingisselected.

4‐18MonitoringECGExpressionMR200InstructionsforUse

NOTE

To make global changes to the parameter alarm limit settings based upon the patient’s current

vital sign readings, see Setting Alarm Limits Globally on page 9-4.

ECG Menu

TheECGmenuallowsyoutocontrolECG

traces,functionsandsettings.

TochangesettingsintheECGmenu

4Turntheknobtochangethesettingvalueandthenpresstheknob

tomakethechangeeffectiveandreturntothescrollingfunction.

Thesettingischanged.

5Tochangetheremainingsetting,repeatsteps3and4.

Step Action

1TurnthecontrolknobtohighlighttheECGVSboxandthenpress

theknob.

TheECGmenuappears.Currentsettingsaredisplayed.

ExpressionMR200InstructionsforUseMonitoringECG4‐19

ALARM LIMITS

Controlsthealarmlimitsettingsforheartrate.(Seethetableonpage9‐15foralisting.)

2TurnthecontrolknobtoselectanyofthefollowingECGoptions:

ALARMLIMITS

TRACEALEAD

TRACEBLEAD

SCALE

GATINGSOURCE

HRSOURCE

HRTONESOURCE

FILTERMODE

ECGTESTSIGNAL

T‐WAVESUPPRESSION

MAGNETCONTROL

Forinformationabouttheseoptions,seetheappropriatesections

below.

3Turntheknobtothedesiredsettingandthenpresstheknob.

4Tochangeothersettings,repeatsteps2and3.

5PresstheMainkeytoclosethemenu.

Alternative:TurntheknobtoRETURNandthenpresstheknob,or

waitapproximately60seconds.

Definition

1 Is the setting of the high alarm limit

2 Is the current measurement

3 Is the setting of the low alarm limit

Step Action

12

3

4

5

4‐20MonitoringECGExpressionMR200InstructionsforUse

Tosetanalarmlimitforheartrate

SeeChangingtheHeartRateAlarmLimitsonpage4‐17.

TRACE A LEAD

SetstheECG A leadconfiguration.ForbestECGandheartratemonitoring,alwaysselectthe

optimalleadconfiguration,theonethatprovidestheleastartifactandlargestwaveform

detectionformonitoringuse.

Thefollowingchoicesareavailable:

•I

•II(Default)

•III

•AVL

•AVR

•AVF

•OFF

TosettheECGAlead

SeeChangingtheLeadViewonpage4‐14.

TRACE B LEAD

SetstheECG B leadconfiguration,allowingyoutoviewtwoECGwaveformssimultaneously.

Thefollowingchoicesareavailable:

•I

•II

•III

•AVL

•AVR

•AVF

•OFF(Default)

4 Saves the settings then returns to the normal mode

5 Identifies heart rate alarm limits

Definition

ExpressionMR200InstructionsforUseMonitoringECG4‐21

TosettheECGBlead

SeeChangingtheLeadViewonpage4‐14.

SCALE

SetsthescalefortheECG waveforms.Aftermakingthissetting,takenoteofthescaleindicator;

seepage4‐16.Iftheselectedscaleresultsinawaveformwithdistortedorclippedpeaks,

OVERSCALEwillbedisplayedandanothersettingshouldbeselecteduntilthemessagestops.

Thefollowingchoices(inmillimeterspermillivolt)areavailable:

•AUTOmakesthewaveformfilltheECGtracearea(notrecommendedforuseintheMR).

•1mm/mV

•5mm/mV

•10mm/mV(Default)

•15mm/mV

•20mm/mV

•25mm/mV

•30mm/mV

•40mm/mV

TosettheECGscale

SeeSelectingtheScaleonpage4‐13.

NOTE

This setting does not affect the signal analyzed by the monitor for QRS detection and ECG gating.

GATING SOURCE

Setsthecardiacgatingsourcebasedonameasuredsignal.(Thisisthesameoptionasinthe

SPO2menu.)

Thefollowingchoicesareavailable:

•ECGareoutputsthatrepresentthedetectionoftheR‐peakofaQRScomplex,asignalthe

MRsystemcanusedirectlyfortriggering.(Default)

•PULSEaresignalsthatrepresentthedetectionofthepeakoftheperipheralpulsecomplex.

Tosetthegatingsource

SeeUsingtheGatingFeatureonpage4‐26.

4‐22MonitoringECGExpressionMR200InstructionsforUse

NOTE

Trace A is the default output channel for interfacing the cardiac gating input. To use Trace B, set

Trace A to off, and ensure that Trace B is active (that is, not off); see page 4-20.

HR SOURCE

Selectsthesourcethatproducestheheartrate,asdisplayedintheECGVSbox(identicaltoand

interactivewiththesameoptionintheSPO2menu).

Thefollowingchoicesareavailable:

•AUTOselectsthesourceautomaticallyfromthehighestpriorityactiveinput,wherethe

MR200searchesforanothersourceonlywhenLEADFAILoccursorwhenECGisoff.Ifthe

highestpriorityinputisnotfound,thenextrankedparameterissought.Thepriority

rankingisECGandthenSPO2.Ifnoparameterspresentaheartrate,thenNONEis

displayedintheheartrateposition.

•ECG(Default)

•SPO2

Tosettheheartratesource

HR TONE SOURCE

Setsthesourceusedfortheheartratetone(identicaltoandinteractivewithsameoptioninthe

MONITOR>SOUNDADJUSTmenuandintheSPO2menu).

Step Action

1TurnthecontrolknobtohighlighttheECGVSbox(seepage4‐18)

andthenpresstheknob.

TheECGmenuappears.Currentsettingsaredisplayed.

2TurnthecontrolknobtoHRSOURCEandthenpresstheknob.

TheHRSOURCEmenuappears.

3Turnthecontrolknobtoselectoneofthefollowingoptionsand

thenpresstheknob:

AUTO

ECG

SPO2

Thesettingischanged.

ExpressionMR200InstructionsforUseMonitoringECG4‐23

Thefollowingchoicesareavailable:

•OFFremovestheheartsymbolfromthedisplayandnopulsetonewillbesounded.

(Default)

•QRSprovidesatonetriggeredbytheQRSdetectionfromtheECGvitalsign.

•SPO2providesatonemodulatedbytheSPO2vitalsign,wherethelowertheSPO2value,

thelowerthepitch.

Tosettheheartratetonesource

EntertheECGmenu.TurnthecontrolknobtoHRTONESOURCEandpresstheknob.Scrolltothe

desiredsettingandpresstheknob.(Seepage3‐9fordetailedinstructions.)

FILTER MODE

SetsthefilteringmodefortheECGsignal.

NOTES

• Due to the variety of MRI sequence characteristics, if the filter recommendations below do

not provide optimum performance in all cases, the selection of another filter mode may

improve ECG performance.

• ECG performance can be affected by electrode placement, the MRI procedure, the image

slice angle and slice thickness. In situations where ECG performance is not optimal, select

the ECG lead (I, II, III, AVL, AVR, or AVF) that provides the best performance.

• For cases not requiring cardiac gating, start with the Primary filter mode (depending on the

MRI sequence) and switch filters if a gradient artifact is noticed. If a gradient artifact is still

present, check signal strength and try lead I or III.

Thefollowingchoicesareavailable:

•MONITORprovidesfilteringcharacteristicsthatmeetthespecificationoftheAssociation

fortheAdvancementofMedicalInstrumentation(AAMI).Notethatthisfilterwillnot

provideoptimumperformanceduringactiveMRIsequences.

•PRIMARYprovidesthebestpossibleperformanceon0.15to3.0TMRsystemsduringEcho

TraintypeMRIsequences.(Default)

•SECONDARYprovidesthebestpossibleperformanceon0.15to3.0TMRsystemsduring

mostnon‐cardiovascularMRIsequences.

•CARDIACprovidesthebestpossibleperformanceduringcardiovascular(CV)MRI

proceduresthatinvolvesteady‐statefreeprecessionimagingwithbalancedgradient(True‐

FISP,FIESTA,orBalancedFFE)sequenceson1.5and3.0TMRsystems.Forcasesrequiring

cardiacgating,startwiththeCardiacfilterinleadIIandswitchfiltersifgradientartifactis

noticed.Ifgradientartifactisstillpresent,checksignalamplitudeandtryleadIorIII.

•ADVANCEDprovidesthebestpossibleperformanceon1.5and3.0TMRsystemsduring

MRIsequencessuchasneurologicalandcardiovascular.ThisMRIfilterutilizesanadaptive

filterschemeforremovalofgradientartifactgeneratedbyMRsystems. Bestperformance

4‐24MonitoringECGExpressionMR200InstructionsforUse

isachievedusingtheAdvancedFilterECGleadcable,whichallowsplacementofthewECG

moduleoutsideofthebore.

Advancedfilteringoperatesononeleadatatimefromarestrictedsetofleadsandcannot

beappliedtoAVR,AVLorAVFleads.Toprovidethemostconvenienttransitiontothis

filterandleadconfiguration,thesystemwillautomaticallyselecttheleadtouseby

applyingthefollowingrulesintheordershownbelow:

1. IfTraceAisdisplayed,thecurrentlyselectedleadonTraceAwillbeusedbutonlyifit

isleadI,IIorIII.

2. IfTraceBisdisplayed,thecurrentlyselectedleadonTraceBwillbeusedbutonlyifit

isleadI,IIorIII.

3. Ifneitherrule1norrule2apply,thenleadIIwillbeused.

ThesystemdisplaystheselectedleadonTraceAanddisablesdisplayofTraceB.Youcan

changewhichleadisfiltered,whiletheADVANCEDfilteroperatesbychanginglead

selectionforTraceA.However,onlyleadsI,IIandIIIwillbeavailablewhiletheADVANCED

filterisengaged.(TodeselectADVANCED,selectadifferentfilteroptionfromthemenu.

Thedisplaywillremainunchanged;however,TraceBcanbere‐enabledatthispointif

desired.)

Tosetthefiltermode

SeeSelectingtheFilterModeonpage4‐15.

ECG TEST SIGNAL

GeneratesanECGcalibrationwaveform.

Thefollowingchoicesareavailable:

•OFFturnsthecalibrationfeatureoff.(Default)

•PRINTERsendsa1mVpulsecalibrationwaveformtotheECGvitalsignandalsotothe

printer,ifsoconfigured,whereECGTESTSIGNALwillbeprintedbelowthewaveform.

•ECGsendsawECGmodulegenerated1mVpeaktopeakcalibrationsquarewavetothe

ECGvitalsignandalsototheprinter,ifsoconfigured,whereECGTESTSIGNALwillbe

superimposedoverthewaveformand60BPMwillbedisplayedintheECGVSbox.

TogeneratetheECGtestsignal

EntertheECGmenu.TurnthecontrolknobtoECGTESTSIGNALandpresstheknob.Scrolltothe

desiredoutputandpresstheknob.

NOTES

• Available on all lead configurations, except Lead III.

• Unavailable when FILTER MODE is set to ADVANCED.

• Automatically set to off during interoperability; see GATING SOURCE on page 4-21.

ExpressionMR200InstructionsforUseMonitoringECG4‐25

T-WAVE SUPPRESSION

ReducestheT‐waveamplitudewhenextremelylargeduetothemagnetohydrodynamiceffect

(MHD),whichcanpreventgating.UseforaccurategatingwhenanunusuallyhighT‐wave

amplitude,relativetotheR‐waveamplitude,isseen.

Thefollowingchoicesareavailable:

•OFF(Default)

•ON

ToapplyT‐wavesuppression

EntertheECGmenu.TurnthecontrolknobtoT‐WAVESUPPRESSIONandpresstheknob.Scroll

tothedesiredsettingandpresstheknob.

NOTES

• Unavailable when FILTER MODE is set to MONITOR; see page 4-23.

• Controlled by the gating box through the wECG module during interoperability; see

GATING SOURCE on page 4-21. With the wBTU, T-WAVE SUPPRESSION will be set

to off; and, with other OEM gating boxes, it will be set as it is in the gating box.

MAGNET CONTROL

RemovesgradientartifactsoncertainMRsystemsequippedwithvectorECG

gating.Onthesesystems,onlyonewECGmoduleneedstobeconnectedto

thepatientinorderfortheMR200andtheMRsystemtomonitorthe

patient'svitalsignsandgatethemagnet.

Thefollowingchoicesareavailable:

•AUTOMODEallowstheMRsystemtowork,ifcapable,withtheMR200

toeffectivelyremovegradientartifactsfromtheECGwaveform.When

selectedandwiththewECGmoduleinradiocontactwiththeMR

system,FILTERMODE,T‐WAVESUPPRESSIONandECGTESTSIGNAL

willbedisabledandlocked.(Default)

MAGNETCONTROLwillbedisplayedtoindicatethatfiltermode

selectionhasbeenpreemptedbytheMRsystem.Inaddition,ifHR

SOURCEissettoECG,theheartrateasderivedfromtheMRsystemwill

bedisplayed(abriefinterruptioninthedisplayedwaveformispossible)

andMAGNETFILTERwillbedisplayed.

IftheMR200orthewECGmoduleceaseradiocontactwiththeMR

system,theMR200willresetitsfilterandT‐wavesuppressionoptions

tothesettingsheldpriortocontactwiththeMRsystem.

4‐26MonitoringECGExpressionMR200InstructionsforUse

NOTE

FILTER MODE and T-WAVE SUPPRESSION settings will not be recalled when in MAGNET

CONTROL or MAGNET FILTER mode. And, if a system recall is performed and then the

MR200 is moved from the MR environment, the filter and T-wave suppression options will revert

to their previous settings.

•DISABLEDallowstheMR200tocontrolfilteringandT‐wavesuppression.

Toallowmagnetcontrol

EntertheECGmenu.TurnthecontrolknobtoMAGNETCONTROLandpresstheknob.Scrollto

thedesiredsettingandpresstheknob.

Using the Gating Feature

ThegatingfeatureprovidesfacilitiesforlowlatencyMRItriggeringandsynchronizationbasedon

themeasuredECGorSPO2signal.DatameasuredandtransmittedbythewECGorwSPO2

moduleisprocessedbytheMR200andthenoutputfromthegatingconnector;seepage1‐16for

thelocation,andseepageA‐11forsignaldetails.(Signalscanalsotransmittedbytheoptional

wBTU.)

Using ECG Gating

ToreceiveECGgatingsignals

Step Action

1VerifythewECGmodulestatusbycheckingthestatusindicator:

• Solidgreen=BatterypowerOK/Goodcommunication

• Flashinggreen=BatterypowerOK/Nocommunication

• Solidred=Lowbatterypower/Goodcommunication

• Flashingred=Lowbatterypower/Nocommunication

2Ensurethattheleadcableisproperlyattachedtothepatient;see

AttachingtheLeadCableonpage4‐8.

(ECGoutputsareenabledbydefault;seepage4‐21.)

ExpressionMR200InstructionsforUseMonitoringECG4‐27

Using SPO2 Gating

ToreceiveSPO2gatingsignals

Step Action

1VerifythewSPO2modulestatusbycheckingthestatusindicator:

• Solidgreen=BatterypowerOK/Goodcommunication

• Flashinggreen=BatterypowerOK/Nocommunication

• Solidred=Lowbatterypower/Goodcommunication

• Flashingred=Lowbatterypower/Nocommunication

2EnsurethattheSPO2attachmentisproperlyattached;seeApply‐

ingtheSPO2AttachmenttothePatientonpage5‐3.

3TurnthecontrolknobtohighlighttheSPO2VSbox(seepage5‐7)

andthenpresstheknob.

TheSPO2menuappears.Currentsettingsaredisplayed.

4TurnthecontrolknobtoGATINGSOURCEandthenpresstheknob.

TheGATINGSOURCEmenuappears;seepage5‐12.

5TurntheknobtoPULSEandthenpresstheknob.

Thesettingisapplied.

4‐28MonitoringECGExpressionMR200InstructionsforUse

ExpressionMR200InstructionsforUseMonitoringSPO25‐1

CHAPTER 5

Monitoring SPO2

Thepulseoximetryfeatureusesamotion‐tolerantsignalprocessingalgorithmbasedonFourier

ArtifactSuppressionTechnology(FAST)toprovideoxygenatedhemoglobinmeasurements,a

visualpulseindicationandapulserate,specifically:

•Oxygensaturationofarterialblood(SPO2):Thepercentageofoxygenatedhemoglobinin

relationtothesumofoxyhemoglobinanddeoxyhemoglobin(functionalarterialoxygen

saturation).

• Plethysmography(pleth)waveform:Avisualindicationofthepatient’spulsatileblood

flow.

•Pulserate(asderivedfromtheplethwaveform):Thenumberofdetectedpulsationsper

minute.

NOTE

A pulse oximeter should be considered an early warning device. As a trend toward patient

deoxygenation is indicated, blood samples must be analyzed by a laboratory co-oximeter to

understand the patient’s condition completely.

wSPO2 Module, Sensor and Attachment

ThewSPO2module,sensorandattachment(cliporgrip)areintendedforpatientuseswhen

continuousnon‐invasivearterialoxygensaturation,pulseratemonitoringorpulsegatingare

required.ThewSPO2module,sensorandattachmentmaybeusedintheMRsystembore,

althoughthemodulemustnotbeplacedwithintheMRIfieldofview(FOV).

CAUTION

If dropped, the wSPO2 module must be verified for correct operation before use.

NOTE

Refer to your facility's biohazard procedure for disposal of SPO2 attachments and sensors when

they become unusable. Usually sensors are disposed of as medical waste per facility procedures.

5‐2MonitoringSPO2ExpressionMR200InstructionsforUse

Patient Preparation for SPO2 Monitoring

WhenmonitoringSPO2,thesiteselectedonthepatient,theSPO2attachment,theattachment’s

positiononthepatient,andtheambientenvironmentwillimpacttheperformanceand

operationoftheparameter.

Selecting the Site and Attachment

Whenapplyingtheclipsorgripstothepatient,sitepreparationandthepressureandalignment

oftheattachmentareimportantfactorstoconsider.Selectthemostappropriatelimbthatbest

fitstheattachmentsize.Formeasurementstobeaccurateandreliable,theoptimumfitis

reachedwhenthefiberheadwindowsopposeeachotherandarecoveredbyskinornail.Refer

totheinstructionsprovidedwiththeattachmentwhenselectingandconnectingthecliporgrip.

Attaching the Clip or Grip to the SPO2 Sensor

Toattachtheclips(orgrips)totheSPO2sensor

SnapthefiberheadsontheSPO2sensorintothe

receptacles(windows)ontheSPO2attachment

(cliporgrip).

SPO2 sensor

SPO2 attachment (clip

shown)

Fiber heads

ExpressionMR200InstructionsforUseMonitoringSPO25‐3

Applying the SPO2 Attachment to the Patient

ReadthewarningsbeforeapplyinganSPO2attachmenttothepatient.

WARNINGS

•General fit: If a clip or grip is too loose, it might compromise the optimal alignment or

dislocate. If the clip or grip is too tight (for example, if the application site is too large

or becomes large due to edema), excessive pressure may be applied resulting in venous

congestion distal from the application site, which could lead to interstitial edema,

hypoxemia, tissue malnutrition, and inaccurate measurements. Skin irritations may

occur as a result of the clip or grip being attached to one location for too long.

Periodically inspect the clip or grip application site and change the application site at

least every 4 hours. Exercise care when using tape to secure the clip or grip, as the

stretch memory properties of most tapes can apply unintended pressure to the site

easily.

• Extremities to avoid: Avoid placing the clip or grip on extremities with an arterial

catheter, intravascular venous infusion line, or inflated blood pressure cuff. Failure to

do so may result in inaccurate readings or false alarm indications.

• Protect the sensor from contact with any liquid. If the sensor, clips or grips show signs

of damage like exposed fibers, replace the part immediately. Do not use damaged

equipment.

• Keep detached grips and clips away from small children to avoid possibility of

swallowing.

Toapplyareusablecliptothepatient

Step Action

1 Selecttheapplicationsite.Itshouldmatchtheclipsizesothatthe

sensordoesnotfallofforapplyexcessivepressureatthesite.

2Ifpresent,removeanycolorednailpolishfromtheapplicationsite.

3Pressthecliptoopen.

4Pushtheclipoverafingersoeither

fiberheadisonthetopovertheroot

ofthenailandtheotherfiberhead

oppositetoit.(Itdoesnotmatter

whichheadisontop.)

5Ensurethatthefingeristouchingthestopatthecushionandlays

nicelycenteredintheclip.

5‐4MonitoringSPO2ExpressionMR200InstructionsforUse

Toapplyadisposablecliptothepatient

Toapplyadisposableneonatecliptothepatient

Step Action

1 Selecttheapplicationsite.Itshouldmatchtheclipsizesothatthe

sensordoesnotfallofforapplyexcessivepressureatthesite.

2Ifpresent,removeanycolorednailpolishfromtheapplicationsite.

3Liftoffthereleaselinersthatprotecttheadhesive.

4Putthefinger(ortoe)ontoeithersideoftheattachment‐theyare

symmetrical‐suchthatthetipcoversthewindowcompletelyand

doesnotprotrudeoverthehinge.

5Closethegrip.Ifthefitisgood,presstheattachmentfirmlyonthe

fingerortoe.Ifthefitisnotgood,repositiontheattachment.Make

surethelimbiscenterednicelyintheattachment.

6Wrapthefoamwingsaroundthe

fingerandattachmentandstickto

theopposinggripside.Donotstretch

thefoamtoapplyexcessivepressure.

Step Action

1 Selecttheapplicationsite.Itshouldmatchtheclipsizesothatthe

sensordoesnotfallofforapplyexcessivepressureatthesite.

2Liftoffthereleaselinersthatprotecttheadhesive.

3 Proceedaccordingtotheapplicationsite:

• Footapplication:Alignthehingeontheoutsidefacingridge

ofthefoot.Makesuretheattachmentisasfaraspossible

towardthesmalltoebutnotoverit.

•Hand/Wristapplication:Alignthehingeontheoutsidefacing

ridgeofthehandorwrist.Youmayhavetoswivelthefiber

headstoanoptimalpositiontoeasetheapplication.

4Withthehingealignedwiththeridgeofthefoot/hand/wrist,press

onesidetotheskinandthenwraptheothersidearoundthelimb

pullingthelongfoampiecegently.

5Pressbothfiberheadsgentlytoattach

theadhesives.

ExpressionMR200InstructionsforUseMonitoringSPO25‐5

WARNING

Disposable attachments are designed for single patient use and must be

disposed after use. They must not be cleaned and reused. Follow your hospital’s

guidelines for appropriate disposal. Reuse of single-use devices can result in

spread of patient infection, degradation of monitoring performance, or

inaccurate measurements.

Positioning the wSPO2 Module for Scanning

Toensurethebestperformance,specificpositioningconsiderationsarerequiredwhenusingthe

wSPO2moduleintheMRmagnetroom,includingharshscansequenceswithperipheralnerve

stimulationlevelsabove80percent.

WARNING

If the wSPO2 module is incorrectly positioned when used within the MR magnet room, the

following factors can cause SPO2 waveform distortion and numeric inaccuracies, and

respiration numeric inaccuracies:

• Fast magnetic field changes usually found but not limited to scan sequences using PNS

levels above 80 percent.

• Severe vibrations induced by scan sequences using PNS levels above 80 percent.

• Distance from the bore opening.

• Distance from the bore iso-center in the x, y, or z direction.

ToensurebestperformanceduringSPO2measurements

6Securethelongerfoampiecebypressingitfirmlytothefoam/

adhesiveoftheopposingside.

7Ensurethatthetwofiberheadsareopposingandhavegoodskin

contact.Theanglebetweenthetwofiberheadsshouldbeassmall

aspossible,notexceeding45°.Iftheattachmentopenstoomuch,

reattachortryanothersite.

Step Action

1Ensurethatthefiberheads(thelightemitterandthe

photodetectorinthecliporgrip)aredirectlyoppositeeachother,

asthelightmustpassthroughthepatient’stissueandbereceived

forproperoperation.

2Swiveleachfiberheadintoapositionthatcausestheleastbending

ofthecablewhileprovidingthemostcomforttothepatient.

5‐6MonitoringSPO2ExpressionMR200InstructionsforUse

3VerifythewSPO2modulestatusbycheckingthestatusindicator:

• Solidgreen=BatterypowerOK/Goodcommunication

• Flashinggreen=BatterypowerOK/Nocommunication

• Solidred=Lowbatterypower/Goodcommunication

• Flashingred=Lowbatterypower/Nocommunication

4

PressthePatientkeyandthenselecttheappropriate

PATIENTtype;seepage3‐10fordetails.

5CheckforanydisplayedSPO2messagesand,ifamessageis

present,followtherecommendedactiontoachievebetterresults

(seepage9‐16).

6Whileconsideringthescantobe

performed,placethewSPO2moduleonor

nearthepatientandascloseaspossibleto

theboreopening.Keepthesensorand

moduleoutsidethefieldofview.

7Placethemoduleascloseaspossibletotheboreopening.(Ifthe

modulecanbeplacedoutsidethebore,positioningattheiso‐

centerisnotnecessary.)

8PlacethemoduleonacushionedsurfacetominimizeMR

vibrations.

9Covertheattachmentsiteonthepatientwithopaquematerial.

10

Duringmeasurement,checkthepatienttoensurethatthe

applicationsitehasapulsatileflowandthatthesitehasnot

changedinthickness(forexample,duetoedema)causingan

improperfit.

Step Action

ExpressionMR200InstructionsforUseMonitoringSPO25‐7

SPO2 Waveform and VS Box

TheelementscontainedintheSPO2waveform(TraceC)andVSboxaredescribedbelow:

Changing the Waveform Speed

TochangetheSPO2(andECG)waveformspeed

Definition

1 Is the high limit setting of the SPO2 alarm; see page 5-10

2 Is the low limit setting of the SPO2 alarm; see page 5-10

3 Is the heart rate numeric and the unit of measure, where BPM is beats per minute.

4 Is the name of the vital sign

5 Is the detected SPO2 waveform, not proportional to pulse volume and can be

amplitude-adjusted for viewing; see page 5-8.

6 Is the SPO2 measurement (numeric), given as a percentage

1

2

3

4

56

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

3TurntheknobtoSWEEPSPEEDandthenpresstheknob.

TheSWEEPSPEEDmenuappears;seepage3‐14.

4Turnthecontrolknobtoselecteitherofthefollowingsettingsand

thenpresstheknob:

50mm/s

25mm/s

Theselectionisentered.

5‐8MonitoringSPO2ExpressionMR200InstructionsforUse

Changing the SPO2 Waveform Amplitude

TochangetheSPO2waveformamplitude

Changing the SPO2 Alarm Limits

TochangetheSPO2alarmlimitsettings

NOTE

To make global changes to the parameter alarm limit settings based upon the patient’s current

vital sign readings, see Setting Alarm Limits Globally on page 9-4.

Step Action

1

TurnthecontrolknobtohighlighttheSPO2VSbox(seepage5‐9)

andthenpresstheknob.

TheSPO2menuappears.Currentsettingsaredisplayed.

2

TurnthecontrolknobtoSIZEandthenpresstheknob.

TheSIZEmenuappears;seepage5‐11fordetails.

3Turn

thecontrolknobtoselectoneofthefollowingoptionsand

thenpresstheknob:

10,20,40,60,80or100percent

Thesettingischanged.

Step Action

1

TurnthecontrolknobtohighlighttheSPO2VSbox(seepage5‐9)

andthenpresstheknob.

TheSPO2menuappears.Currentsettingsaredisplayed.

2

TurnthecontrolknobtoALARMLIMITSandthenpresstheknob.

TheALARMLIMITSmenuappears.Currentsettingsaredisplayed;

seepage5‐10fordetails.

3

Turntheknobtothel

oworhigh

settingandthenpresstheknob.

Thesettingisselected.

4

Turntheknobtochangethesettingvalueandthenpresstheknob

tomakethechangeeffectiveandreturntothescrollingfunction.

Thesettingischanged.

5Tochangetheremainingsetting,repeatsteps3and4.

ExpressionMR200InstructionsforUseMonitoringSPO25‐9

Assessing Suspicious SPO2 Readings

Pulseoximetrymeasurementsarestatisticallydistributed.Withneweralgorithms,suchasFAST‐

SPO2,thecalculationofSPO2isnotdirectlylinkedtothecorrectdetectionofeachpulse.When

thepulserateisveryloworastrongarrhythmiaispresent,theSPO2/plethysmographypulse

ratemaydifferfromtheheartratecalculatedfromECG.Thisdoesnotindicateaninaccurate

SPO2value.IfyoudoubtthemeasuredSPO2,usetheplethysmographywavetoassessthesignal

quality.

WARNINGS

•Always shield (for example, cover with opaque material) the SPO2 clip or grip from

extraneous incidental light sources, as such light can cause erroneous SPO2 readings

or pulse detection errors.

• SPO2 monitoring requires the detection of valid pulses to correctly determine SPO2

and heart rate values. Any of the following items can lead to inaccuracies of the SPO2

readings and/or prolonged measurement time: Ambient light (including photodynamic

therapy), physical movement (patient and imposed motion), arrhythmias and/or

erratic heartbeats, diagnostic testing, electromagnetic interference, electrosurgical

units, dysfunctional hemoglobin, intravascular dyes, presence of dyes or pigments at

the application site, and inappropriate positioning of the pulse oximeter attachment. If

questionable readings are obtained, check the patient’s vital signs by alternate means

before administering medication.

•Attachment movement, ambient light (especially strobe or flashing lights) or

electromagnetic interference can give unexpected intermittent readings when the

sensor is not attached to a patient. Bandage and grip attachment designs are

particularly sensitive to minimal movement that might occur when the sensor is

dangling, not attached to the patient. An unapplied sensor may cause readings to be

displayed on the monitor. To avoid misdiagnosis, ensure the sensor is applied to

patient correctly.

SPO2 Menu

TheSPO2menuallowsyoutocontrolSPO2functions

andsettings.

5‐10MonitoringSPO2ExpressionMR200InstructionsforUse

TochangesettingsintheSPO2menu

ALARM LIMITS

ControlstheSPO2alarmlimitsettings.(Seethetableonpage9‐15foralisting.)

Step Action

1TurnthecontrolknobtohighlighttheSPO2VSboxandthenpress

theknob.

TheSPO2menuappears.Currentsettingsaredisplayed.

2TurnthecontrolknobtoselectanyofthefollowingSPO2options

andthenpresstheknob:

ALARMLIMITS

SIZE

AVERAGINGTIME

GATINGSOURCE

HRSOURCE

HRTONESOURCE

Forinformationabouttheseoptions,seetheappropriatesections

below.

3Turntheknobtothedesiredsettingandthenpresstheknob.

4Tochangeothersettings,repeatsteps2and3.

5PresstheMainkeytoclosethemenu.

Alternative:TurntheknobtoRETURNandthenpresstheknob,or

waitapproximately60seconds.

12

3

4

5

ExpressionMR200InstructionsforUseMonitoringSPO25‐11

TosetthealarmlimitsforSPO2

SeeChangingtheSPO2AlarmLimitsonpage5‐8.

SIZE

ChangestheverticalscaleoftheSPO2(pleth)waveformsothathighamplitudescanbescaled

downtoavoidclippingofthepeaksandlowamplitudescanbescaleduptoviewthepeaks.

Thefollowingchoicesareavailable:

•10%

•20%

•40%

•60%

•80%

•100%(Default)

ToadjustthesizeoftheSPO2waveform

SeeChangingtheSPO2WaveformAmplitudeonpage5‐8.

AVERAGING TIME

Selectshowquicklythereadingrespondstochangesinthepatient’ssaturation,whereselecting

alongerdurationwillpreventthesaturationvaluefromchangingquicklywhichcanbeusefulfor

avoidingalarmtriggeringinpatientswithverydynamicconditionssuchasneonataland

pediatrics.

Thefollowingchoices(inseconds)areavailable:

•5S

•10S(Default)

•15S

Definition

1 Is the setting of the high alarm limit

2 Is the current measurement

3 Is the setting of the low alarm limit

4 Saves the settings and returns to the normal mode

5 Identifies SPO2 alarm limits

5‐12MonitoringSPO2ExpressionMR200InstructionsforUse

TosettheaveragingtimeoftheSPO2reading

EntertheSPO2menu.TurnthecontrolknobtoAVERAGINGTIMEandpresstheknob.Scrollto

thedesiredtimeandpresstheknob.

GATING SOURCE

Setsthecardiacgatingsourcebasedonameasuredsignal.(ThisisthesameoptionasintheECG

menu.)

Thefollowingchoicesareavailable:

•ECGisanoutputthatrepresentsthedetectionoftheR‐peakofaQRScomplex,asignalthe

MRsystemcanusedirectlyfortriggering.(Default)

•Pulseisasignalthatrepresentsthedetectionofthepeakoftheperipheralpulsecomplex.

Tosetthegatingsource

SeeUsingtheGatingFeatureonpage4‐26.

HR SOURCE

Selectsthesourcethatproducestheheartrate,asdisplayedintheECGandSPO2VSboxes

(identicaltoandinteractivewiththesameoptionintheECGmenu).

Thefollowingchoicesareavailable:

•AUTOselectsthesourceautomaticallyfromthehighestpriorityactiveinput,wherethe

MR200searchesforanothersourceonlywhenLEADFAILoccursorwhenECGisoff.Ifthe

highestpriorityinputisnotfound,thenextrankedparameterissought.Thepriority

rankingisECGandthenSPO2.Ifnoparameterspresentaheartrate,thenNONEis

displayedintheheartrateposition.

•ECGselectsECG.(Default)

•SPO2selectsSPO2.

Tosettheheartratesource

Step Action

1TurnthecontrolknobtohighlighttheSPO2VSbox(seepage5‐7)

andthenpresstheknob.

TheSPO2menuappears.Currentsettingsaredisplayed.

2TurnthecontrolknobtoHRSOURCEandthenpresstheknob.

TheHRSOURCEmenuappears.

ExpressionMR200InstructionsforUseMonitoringSPO25‐13

HR TONE SOURCE

Setsthesourceusedfortheheartratetone(identicaltoandinteractivewithsameoptioninthe

MONITOR>SOUNDADJUSTmenuandintheECGmenu).

Thefollowingchoicesareavailable:

•OFFremovestheheartsymbolfromthedisplayandnopulsetonewillbesounded.

(Default)

•QRSprovidesatonemodulatedbytheQRSdetectionfromtheECGvitalsign.

•SPO2providesatonemodulatedbytheSPO2vitalsign,wherethelowertheSPO2value,

thelowerthepitch.

Tosettheheartratetonesource

EntertheSPO2menu.TurnthecontrolknobtoHRTONESOURCEandpresstheknob.Scrollto

thedesiredsettingandpresstheknob.(Seepage3‐8fordetailedinstructions.)

3Turnthecontrolknobtoselectoneofthefollowingoptionsand

thenpresstheknob:

AUTO

ECG

SPO2

Thesettingischanged.

Step Action

5‐14MonitoringSPO2ExpressionMR200InstructionsforUse

ExpressionMR200InstructionsforUseMonitoringNiBP6‐1

CHAPTER 6

Monitoring NiBP

TheNiBP(non‐invasivebloodpressure)parametermeasuresanddisplayssystolic,diastolicand

meanarterialpressures.Alarmlimitsettingsareavailableforallthreepressures.Whenusing

NiBPtomeasurebloodpressure,readingsarenotcontinuousbutareupdatedeachtimeablood

pressuremeasurementistaken.Setashorterintervalwhenfrequentupdatingofthepatient’s

bloodpressureisneeded.Visuallycheckingthepatient,confirmingNiBPmeasurementsagainst

othervitalsignmeasurementsandattentiontothelimbwherethecuffisattachedmustbe

standardroutinesduringNiBPuse.

Adultandpediatricbloodpressuremeasurementsdeterminedwiththisdeviceareequivalentto

thoseobtainedbyatrainedobserverusingthecuff/stethoscopeauscultatorymethod,withinthe

limitsprescribedbytheAmericanNationalStandard,Manual,electronic,orautomated

sphygmomanometers.

Neonatalbloodpressuremeasurementsdeterminedwiththisdeviceareequivalenttothose

obtainedbyanintra‐arterialbloodpressuremeasurementdevice,withinthelimitsprescribedby

theAmericanNationalStandard,Manual,electronic,orautomatedsphygmomanometers.

WARNINGS

•Use clinical judgment to decide whether to perform a repeated series of NiBP

measurements because of the risk of purpura, ischemia and neuropathy in the limb

with the NiBP cuff.

• Arrhythmias, erratic heartbeats and patient motion can result in inaccurate readings

and/or prolonged measurements. If questionable readings are obtained, check the

patient’s vital signs by alternate means before administering medication.

• The performance of the automated sphygmomanometer can be affected by extremes of

temperature, humidity and altitude.

• An alarm will sound when the MR200 is too close to the MR magnet and shutdown of

NiBP monitoring will occur. Always position the MR200 as indicated on page 2-6.

CAUTIONS

• Substitution of components or accessories different from those supplied or recommended

can result in measurement errors.

• NiBP accuracy has not been verified in the presence of some common arrhythmias such as

atrial or ventricular premature beats or atrial fibrillation.

6‐2MonitoringNiBPExpressionMR200InstructionsforUse

Patient Preparation for NiBP Monitoring

WARNING

The NiBP cuff inflation rate may increase and the initial pressure may increase up to 180

mmHg when changing the patient type.

ThePATIENTtypesettingdeterminestheinflationpressuresoftheNiBPcuffandthereading

times.

Insomecases,apatientmayexhibitalowpulseamplitudeduetoanyofthefollowing

conditions.Thelistprovidesonlysomeexamplesofpotentialcausesoflowpulseamplitudesthat

canmakeNiBPdifficulttomeasureinaconvenientandtimelymanner:

• Medication

•Sedation

•Diseaseorillness

• Physiologicalorneurologicalconditions

•Obesity(oranyoccurrenceofmetabolismwithextremevariations)

• Stress

•Size

CAUTION

There may be occasions when a particular mode is not suitable for its apparent category of patients

based on age alone. In these cases, a clinical decision shall be made to use another patient type,

NiBP cuff size or measurement technique. The clinical decision shall be based on all of the factors

listed in Determining the Patient Type (see page 3-10) to ensure the best possible and most timely

NiBP measurement acquisition.

NOTE

ADULT and PEDIATRIC types dictate use of a larger NiBP cuff and interconnect hose size,

while NEO uses smaller sizes; see the cuff and hose information on page 1-27.

AwidevarietyofNiBPcuffsandinterconnecthosesareavailableforyourmonitoringneeds;see

page1‐27fordetails.

ExpressionMR200InstructionsforUseMonitoringNiBP6‐3

Selecting the NiBP Cuff

WARNING

To ensure accurate reliable measurements, use only the recommended NiBP accessories. Use

the appropriate NiBP cuff size for each patient, as recommended by the current American

Heart Association guidelines for blood pressure monitoring, to ensure safety and accuracy.

TheNiBPcuffshouldbeselectedand

positionedasitwouldbeforanauscultatory

bloodpressuredetermination.Thecurrent

guidelinesoftheAmericanHeartAssociation

mustbefollowed.

Thebladderwidthofthecuffmustbe40

percentofthecircumferenceofthelimb.Itis

alsoadvisabletokeeptheairvolumetoa

minimumbyusingthesmallestcuffsize

possibleforeachpatient.Thepointof

maximumoscillationsiscoincidentwithmean

arterialpressureregardlessofarterialelasticity

solongastheratioofairvolumeinthecuffto

thevolumeofthearteryundercompression

doesnotgreatlyexceedten(10)toone(1).

ForacorrectNiBPcufffit:

•Adultandpediatricpatients—theindex

lineonthesizechosenshouldfallwithin

therangelinewhenplacedonthe

patient.

• Neonatalpatients—thesizechosen

shouldbewithinthestated

circumferencerangeforthelimbofthe

neonate.

•Allpatients—alignthecufftoensurethe

arterymarkisplacedovertheartery.

WARNING

Single use devices, as indicated on the device packaging, should be disposed of

after use and must never be reused. Follow your hospital’s guidelines for

appropriate disposal. Reuse of single-use devices can result in spread of patient

infection, degradation of monitoring performance, or inaccurate

measurements.

Index line

Range line

Circumference

range

Artery mark

NiBP cuff

6‐4MonitoringNiBPExpressionMR200InstructionsforUse

Positioning the NiBPCuff

WARNINGS

•Avoid compression, kinking or restriction of the NiBP cuff hose, as the effect of blood

flow interference can result in patient injury caused by continuous cuff pressure.

• Do not use the NiBP cuff on a limb with an intravenous infusion or where an arterial

catheter or arterio-venous (A-V) shunt is in place because of temporary interference to

blood flow. This could result in injury to the patient.

• Do not place the NiBP cuff over a wound, as this can cause further injury.

• Do not place the NiBP cuff on the same or adjacent arm to a mastectomy, or where the

lymph nodes were removed, or if a shunt is on that arm. This can lead to bruising,

inaccurate readings, or negatively impact the drainage of fluids because of temporary

interference to blood flow.

WraptheNiBPcufffirmly(notsnuggly)aroundthearmorlegofthepatient,makingsurethat

thecuffisattheapproximatelevelofthehearttoensureaccuracyoftheobtainedvalues.

Connecting the NiBP Cuff

WARNING

Routinely inspect the NiBPcuff and hose assemblies for proper connection and orientation.

Replace accessories that have cracks, holes, tears, or cuts that could cause leaks in the

system. If such damaged NiBP cuff or hose assemblies are used, prolonged and/or inaccurate

patient readings could result.

ToconnecttheNiBPcuffandhose

Step Action

1Insertthe

appropriate

interconnecthose

connectorontothe

NiBPport.Pushthe

hoseconnector

forwardandthen

turnitclockwise.

2AttachaNiBPcuffappropriateforthepatienttypeandsizetothe

interconnecthose.

NiBP port

ExpressionMR200InstructionsforUseMonitoringNiBP6‐5

Choosing the Measurement Mode

NiBPmeasurementscanbetakenusingamode(autoormanual)thatbestsuitstheneedsof

yourpatient.

Selecting Auto Mode

Youcanautomaticallymeasureapatient’sbloodpressureatpre‐definedintervals,whichare

measuredfromthestartofoneNiBPmeasurementtothestartofthenext.

Toturnonautomaticoperation

3 Positionthecuffonthepatient;seepage6‐4.

4Ensurethatthecuffandinterconnecthosesarenotkinked.

Step Action

1PressthePatientkeyandthenselecttheappropriate

PATIENTtype;seepage3‐10fordetails.

2TurnthecontrolknobtohighlighttheNiBPVSbox(seepage6‐11)

andthenpresstheknob.

TheNiBPmenuappears.Currentsettingsaredisplayed.

3TurnthecontrolknobtoINTERVALandthenpresstheknob.

TheINTERVALmenuappears.Thecurrentsettingishighlighted.

4Turnthecontrolknobtoselectanyofthefollowingsettingsand

thenpresstheknob:

1,2,2.5,3,5,10,15,20,30and45minutes,and1,2and4hours.

Theselectionisentered.

5TurnthecontrolknobtoAUTOMODEandthenpresstheknob.

6TurnthecontrolknobtoONandthenpresstheknob.

7PresstheNiBPkeytobeginmeasurements.

6‐6MonitoringNiBPExpressionMR200InstructionsforUse

NOTE

If gauss shutdown occurs during an AUTO MODE measurement, NiBP readings will stop. When

at a safe distance, operation will resume—a reading will be taken and then the intervals will begin

again.

Making Manual Measurements

Youcanmanuallydefinethemeasurementintervalofapatient’sbloodpressure.

Tocontrolmanualoperation

Initial Inflation Pressures and Reading Durations

WARNINGS

• Too frequent NiBP measurements can cause injury to the patient due to blood flow

interference.

• Always monitor the NiBP cuff site (for example, by observation of the limb concerned)

to ensure that operation of the automated sphygmometer does not result in prolonged

impairment of the circulation of the blood of the patient.

• Pressurization of the NiBP cuff can can temporarily cause loss of function of

simultaneously used monitoring ME equipment on the same limb.

TheinitialinflationpressureistheamountthattheNiBPcuffwillinflateforthefirstNiBP

measurement:

•ADULTisusedformostadultpatients:Initialinflationpressure:165±15mmHg

•PEDIATRICisusedforanypatientexhibitinglowpulseamplitudes(aconditionexhibitedby

pediatric‐sizepatients):Initialinflationpressure:130±15mmHg

•NEOisusedformostneonatalpatients:Initialinflationpressure:100±15mmHg

WhensubsequentNiBPmeasurementsaretakenonthesamepatient(andifnotinsuspend

mode),themonitoradjuststheinflationvalueupordownbasedonthepreviousreadingresults.

Step Action

1PressthePatientkeyandthenselecttheappropriate

PATIENTtype;seepage3‐10fordetails.

2PresstheNiBPkeytostartandstopamanualNiBP

measurement.

ExpressionMR200InstructionsforUseMonitoringNiBP6‐7

Stopping an NiBP Measurement

PresstheNiBPkeytostopareadingcycle.

NiBP VS Box

DependingupontheselectedFORMAT(seepage6‐14),theNiBPVSboxisdisplayedaccordingly.

Systolic/Diastolic Format

TheelementscontainedintheSYS/DIAformataredescribedbelow.

Definition

1 Is the NiBP diastolic pressure measurement (numeric)

2 Is the low limit of the NiBP diastolic alarm setting; see page 6-12

3 Is the high limit of the NiBP diastolic alarm setting; see page 6-12

4 Is the low limit of the NiBP systolic alarm setting; see page 6-12

5 Is the high limit of the NiBP systolic alarm setting; see page 6-12

6 Is the unit of measure for the NiBP pressure readings, where mmHg is millimeters of

mercury and kPa is kilopascals; see PRESSURE UNITS on page 11-16

7 Is the time since the last completed NiBP reading, displayed in the following format:

<hh>:<mm>:<ss>, where

<hh> = Two-digit hours field

<mm> = Two-digit minutes field

<ss> = Two-digit seconds field

NOTE

During a reading, this displays the cuff pressure.

1

2

435

6

7

8

910 11

6‐8MonitoringNiBPExpressionMR200InstructionsforUse

Mean Format

TheelementscontainedintheMEANformataredescribedbelow.

8 Is the name of the vital sign

9 Is the mode: where MANUAL is displayed when in Manual mode, and NEXT when in

Auto mode. In Auto mode, indicates the time until the next NiBP measurement,

displayed in the following format:

<hh>:<mm>:<ss>, where

<hh> = Two-digit hours field

<mm> = Two-digit minutes field

<ss> = Two-digit seconds field

10 Is the NiBP mean pressure measurement (numeric)

11 Is the NiBP systolic pressure measurement (numeric)

Definition

1 Is the NiBP mean pressure measurement (numeric)

2 Is the high limit of the NiBP mean alarm setting; see page 6-12

3 Is the low limit of the NiBP mean alarm setting; see page 6-12

4 Is the unit of measure for the NiBP pressure readings, where mmHg is millimeters of

mercury and kPa is kilopascals; see PRESSURE UNITS on page 11-16

5 Is the time since the last completed NiBP reading, displayed in the following format:

<hh>:<mm>:<ss>, where

<hh> = Two-digit hours field

<mm> = Two-digit minutes field

<ss> = Two-digit seconds field

NOTE

During a reading, this displays the cuff pressure.

6 Is the name of the vital sign

1

2

3

54

6

789

ExpressionMR200InstructionsforUseMonitoringNiBP6‐9

Changing the NiBP Alarm Limits

TochangetheNiBPalarmlimitsettings

NOTE

To make global changes to the parameter alarm limit settings based upon the patient’s current

vital sign readings, see Setting Alarm Limits Globally on page 9-4.

7 Is the mode: where MANUAL is displayed when in Manual mode, and NEXT when in

Auto mode. In Auto mode, indicates the time until the next NiBP measurement,

displayed in the following format:

<hh>:<mm>:<ss>, where

<hh> = Two-digit hours field

<mm> = Two-digit minutes field

<ss> = Two-digit seconds field

8 Is the NiBP systolic pressure measurement (numeric)

9 Is the NiBP diastolic pressure measurement (numeric)

Definition

Step Action

1TurnthecontrolknobtohighlighttheNiBPVSbox(seepage6‐11)

andthenpresstheknob.

TheNiBPmenuappears.Currentsettingsaredisplayed.

2TurnthecontrolknobtoALARMLIMITSandthenpresstheknob.

TheALARMLIMITSmenuappears.Currentsettingsaredisplayed;

seepage6‐12fordetails.

3Turntheknobtothel

oworhigh

settingandthenpresstheknob.

Themeasurementandsettingareselected.

4Turntheknobtochangethesettingvalueandthenpresstheknob

tomakethechangeeffectiveandreturntothescrollingfunction.

Thesettingischanged.

5Tochangeotheralarmsettings,repeatsteps3and4.

6‐10MonitoringNiBPExpressionMR200InstructionsforUse

Changing the Unit of Measure

NOTE

When using the IP5 and PRESSURE UNITS is changed, the displayed formatting of the value

and placement of the decimal point is changed immediately. However, it can take up to 2 seconds

for the numeric values to reflect the new unit of measure. Do not print or perform data captures

during this period.

Tochangetheunitofmeasure

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

3TurnthecontrolknobtoSERVICE(BIO‐MED)andpresstheknob.

TheSERVICE(BIO‐MED)menuappears.

4TurnthecontrolknobtoSYSTEMCONFIGandpresstheknob.

TheSYSTEMCONFIGsubmenuappears.Currentsettingsare

displayed.

5TurnthecontrolknobtoPRESSUREUNITSandthenpresstheknob.

ThePRESSUREUNITSmenuappears.Thecurrentsettingis

highlighted.

6Turntheknobtothedesiredsettingandthenpresstheknob.

mmHg

kPa

Thesettingisselected.

7PresstheMainkeytoclosethemenu.

Alternative:TurntheknobtoRETURNandthenpresstheknob.

ExpressionMR200InstructionsforUseMonitoringNiBP6‐11

NiBP Menu

TheNiBPmenuallowsyoutocontrolnon‐invasiveblood

pressurefunctionsandsettings.

TochangesettingsintheNiBPmenu

Step Action

1TurnthecontrolknobtohighlighttheNiBPVSboxandthenpress

theknob.

TheNiBPmenuappears.Currentsettingsaredisplayed.

2TurnthecontrolknobtoselectanyofthefollowingNiBPoptions

andthenpresstheknob:

ALARMLIMITS

INTERVAL

AUTOMODE

HRSOURCE

HISTORY

FORMAT

Forinformationabouttheseoptions,seetheappropriatesections

below.

3Turntheknobtothedesiredsettingandthenpresstheknob.

4Tochangeothersettings,repeatsteps2and3.

5PresstheMainkeytoclosethemenu.

Alternative:TurntheknobtoRETURNandthenpresstheknob,or

waitapproximately60seconds.

6‐12MonitoringNiBPExpressionMR200InstructionsforUse

ALARM LIMITS

ControlsthealarmlimitsettingsforNiBP.(Seethetableonpage9‐15foralisting.)

TosetthealarmlimitsforNiBP

SeeChangingtheNiBPAlarmLimitsonpage6‐9.

INTERVAL

Setstheintervalforautomaticmeasurements.

Thefollowingchoicesareavailable:

•1Minute

•2Minutes

•2.5Minutes

•3Minutes(Default)

•5Minutes

•10Minutes

Definition

1 Are the settings of the high alarm limits

2 Are the current measurements

3 Are the settings of the low alarm limits

4 Saves the settings and returns to the normal mode

5 Identifies diastolic alarm limits

6 Identifies mean alarm limits

7 Identifies NiBP alarm limits

8 Identifies systolic alarm limits

12

3

4

5

6

7

8

ExpressionMR200InstructionsforUseMonitoringNiBP6‐13

•15Minutes

•20Minutes

•30Minutes

•45Minutes

•1Hour

•2Hours

•4Hours

TosettheintervalforNiBPreadings

EntertheNiBPmenu.TurnthecontrolknobtoINTERVALandpresstheknob.Scrolltothe

desiredtimeandpresstheknob.

AUTO MODE

SetsthemodeusedtotakeNiBPreadings.

NOTE

A manual reading will not restart this cycle time.

Thefollowingchoicesareavailable:

•ONtakesreadingsautomatically.Whenswitchedfromofftoon,thefirstreadingmustbe

initiatedbypressingtheNiBPkey.Allsubsequentreadingswillbetakenautomaticallyat

theselectedinterval.

•OFFtakesreadingsmanually(Manualmode),wherereadingsareinitiatedbypressingthe

NiBPkey.(Default)

TosetthemodeforNiBPreadings

EntertheNiBPmenu.TurnthecontrolknobtoAUTOMODEandpresstheknob.Scrolltothe

desiredmethodandpresstheknob.

HISTORY

Displaysthelast48NiBPreadingswiththetime,heartrate,SPO2,CO2andrespirationvaluesina

tabularform(6perpage).Thisdataisretainedinnon‐volatilememory,protectedagainstpower

loss.

ToviewpreviousNiBPreadings

EntertheNiBPmenu.TurnthecontrolknobtoHISTORYandpresstheknob.

6‐14MonitoringNiBPExpressionMR200InstructionsforUse

FORMAT

Changestheformatofthedisplayedpressurenumerics.

Thefollowingchoicesareavailable:

•SYS/DIAdisplaystheNiBPreadingsinthesystolic/diastolicformat;seepage6‐7.(Default)

•MEANdisplaystheNiBPreadingsinthemeanformat;seepage6‐8.

Tochangetheformat

Step Action

1TurnthecontrolknobtohighlighttheNiBPVSbox(seepage6‐11)

andthenpresstheknob.

TheNiBPmenuappears.Currentsettingsaredisplayed.

2TurnthecontrolknobtoFORMATandthenpresstheknob.

TheFORMATmenuappears.Thecurrentsettingishighlighted.

3Turnthecontrolknobtoselectfromthefollowingsettingsandthen

presstheknob:

SYS/DIA

MEAN

Theselectionisentered.

ExpressionMR200InstructionsforUseMonitoringCO27‐1

CHAPTER 7

Monitoring CO2

WhenequippedwiththeCO2option,theMR200samplesandanalyzesthepatient’sairway

respiratorygasusingsidestreammeasurementtoproduce:

•Aninspired(FiCO2)valuederivedduringinspirationandanendtidal(EtCO2)value

measuredduringexpiration.

•Arespirationrate(RESP):Thenumberofbreathsperminute;seechapter8fordetails.

•Awaveformoftheconcentrationofcarbondioxideintherespiratorygases.

NOTE

Inspired CO2 (FiCO2) is the lowest reading of the CO2 waveform in the previous 20 seconds.

WARNINGS

•Do not use on patients that cannot tolerate the withdrawal of 50ml/min ± 10 ml/min

from the airway or patients that cannot tolerate the added dead space to the airway.

• An alarm will sound when the MR200 is too close to the MR magnet and shutdown of

CO2 monitoring will occur. Always position the MR200 as indicated on page 2-6.

Patient Preparation for CO2 Monitoring

Whenpreparingapatient,theaccessorypositiononthepatientwillimpacttheperformanceand

operationoftheCO2parameter.

Selecting the CO2 Accessory

Inpatientsonabreathingcircuit,asampleoftherespiratorygasisdrawnfromthepatient’s

breathingcircuitthroughanairwayadapterandagassamplingline.Inpatientswhoarenotona

breathingcircuit,thegassampleisdrawnthroughanasalcannula.Thesespeciallydesigned

cannulasandon‐airwayadaptersincorporateafilterandsamplecelltoprovidemaximum

filtrationoffluidsandcontaminantstoprotectagainstsystemintake.WhenselectingCO2

accessories(seepage1‐25),considerthefollowing:

•Thetypeofpatient(adult,pediatric,orneonatal)

•Whetherthepatientisreceivingsupplementaloxygen

•Theconditionofthepatient

7‐2MonitoringCO2ExpressionMR200InstructionsforUse

•Allaccessoriesaresingleuse.

Connecting the Sampling Line

Toconnectthesamplingline

WARNINGS

•Inspect CO2 port and accessories before use. If the sampling line, connector or port

show signs of damage, replace the part immediately or discontinue use and contact

technical support. Never use damaged equipment.

• Frequently inspect the patient sampling line and keep it clear of any moving

mechanisms (for example, table wheels) which could cut, pinch, or dislodge the

sampling line. Leaks, reduced or stopped flow, or internal venting of sampled gas into

damaged tubing will cause inaccurate measurements.

• Do not position the sampling line in any manner that may cause entanglement or

strangulation.

• Replace the sampling line if excessive secretions are observed, as inaccurate

measurements could result if the flow is reduced or stopped.

• Leakages in the breathing system or sampling system may cause the displayed EtCO2

values to be too low. Always connect all components securely and check for leaks

according to standard clinical procedures. Displacement of the sampling line cannula

or airway adapter can cause lower than actual EtCO2 readings.

Step Action

1Insertthesamplinglineconnector

intotheCO2portandthenpushthe

connectorforwarduntilyoufeelor

hearitclickintoplace.

2IfCO2WARMINGUPisdisplayed,waitasthesystemthermally

stabilizes.Whenthemessageiscleared,CO2isfullyoperational.

3AlwaysremovethepatientsamplinglinefromtheCO2portwhen

notinuse.(Toremovethesamplingline,pressdownonthelocking

tabandpulltheconnectorfromtheport.)

NOTE

To increase the life of the filter and pump, when CO2 will not be

used to monitor a patient, it is recommended to turn off CO2 in the

PARAMETER SELECTION menu; see page 3-7.

Sampling line connector

CO2 port

ExpressionMR200InstructionsforUseMonitoringCO27‐3

• If CO2 values for patients who are not on a breathing circuit appear extremely low,

check whether the patient is breathing through the mouth or whether one nostril is

blocked.

NOTES

• For optimum fit and compatibility, use only specified parts.

• Always inspect patient sampling line after attachment to the MR200.

Applying the Sampling Line to the Patient

Selectthepatientsamplinglinethatisappropriateforthepatientsizeandapplication.Patient

samplinglineswiththeairwayadapterareintendedforusewithbreathingcircuitsand

anesthesiacircuitsthathaveanintegratedairwayadapter.

WARNING

Patient sampling lines are intended for single-patient use only. Do not clean or

disinfect these items. Follow your hospital’s guidelines for appropriate disposal.

Reuse of single-use devices can result in spread of patient infection, degradation

of monitoring performance, or inaccurate measurements.

CAUTIONS

• The accuracy of the data is greatly influenced by the proper use and fitting of the patient

sampling line to ensure proper sampling without the introduction of outside air.

• Remove the patient sampling line from the CO2 port when not in use.

Toplacethesamplinglineonthepatient

Step Action

1Ensurethatthesamplinglineisclean,dryandundamaged.Replace

thelineifnecessary.

2InsertthesamplinglineconnectorintotheCO2port(seepage7‐2).

Aclickwillbeheardwhenproperlyinserted.

7‐4MonitoringCO2ExpressionMR200InstructionsforUse

3Placethesamplinglineontothepatient,asshownbelow.

4Ifusingthesamplinglinewiththeairwayadapter,proceedtostep

5;otherwisegotostep7.

5Placetheairwayadapterattheproximalendoftheairwaycircuit

betweentheelbowandthebreathingcircuitwye,asshownbelow.

CAUTION

Always insert the patient sampling line into the CO2 port before

inserting the airway adapter into the breathing circuit. Failure to

follow this may introduce a leak in the circuit, thereby reducing set

minute volume.

NOTE

Do not place the airway adapter between the ET tube and the elbow

as this may allow patient secretions to accumulate in the adapter. If

pooling does occur, replace the airway adapter. To prevent moisture

from draining into the airway adapter, always place the adapter

tubing in a up position, as shown above.

6PressthePatientkeyandthenselecttheappropriate

PATIENTtype;seepage3‐10fordetails.

Step Action

ExpressionMR200InstructionsforUseMonitoringCO27‐5

7Checkthattheconnectionshavebeenmadecorrectlybyverifying

thepatient’sbreathingeffortswiththedisplayedwaveform.

WARNING

Before completion of patient setup, ensure that the

patient’s breathing efforts coincide with the displayed

CO2 waveform.

8Ifthefollowingwarningisdisplayed:

PersistentCO2occlusiondetected.

PleaseclearocclusionandpressOK

toresumeusingCO2

Clearanypinchesorobstructionsinthesamplinglinebefore

proceeding.

Step Action

7‐6MonitoringCO2ExpressionMR200InstructionsforUse

CO2 Waveform and VS Box

TheelementscontainedintheCO2waveform(TraceD)andVSboxaredescribedbelow.

Changing the Waveform Speed

TochangetheCO2waveformspeed

Definition

1 Is the high limit setting of the CO2 alarm; see page 7-9

2 Is the low limit setting of the CO2 alarm; see page 7-9

3 Is the inspired FiCO2 (inspired CO2) measurement (numeric)

4 Is the unit of measure for the CO2 numeric data, where mmHg is millimeters of

mercury and kPa is kilopascals; see page 7-11

5 Is the label for the FiCO2 measurement

6 Is the name of the vital sign

7 Is the detected CO2 waveform

8 Is the label for the EtCO2 measurement

9Is the EtCO2 (expired CO2) measurement (numeric)

1

2

3

5

6

79

8

4

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

ExpressionMR200InstructionsforUseMonitoringCO27‐7

Changing the CO2 Alarm Limits

TochangetheEnd‐tidalCO2alarmlimitsettings

NOTES

• To make global changes to the parameter alarm limit settings based upon the patient’s

current vital sign readings, see Setting Alarm Limits Globally on page 9-4.

• The high alarm limit for inspired CO2 is fixed.

3TurntheknobtoRESPSPEEDandthenpresstheknob.

TheRESPSPEEDmenuappears.Thecurrentsettingishighlighted.

4Turnthecontrolknobtoselectanyofthefollowingsettings(see

page3‐14fordetails)andthenpresstheknob:

25mm/s

12.5mm/s

6.25mm/s

3.125mm/s

1.5625mm/s

0.33333mm/s

Theselectionisentered.

Step Action

1TurnthecontrolknobtohighlighttheCO2VSbox(seepage7‐8)

andthenpresstheknob.

TheCO2menuappears.Currentsettingsaredisplayed.

2TurnthecontrolknobtoALARMLIMITSandthenpresstheknob.

TheALARMLIMITSmenuappears.Currentsettingsaredisplayed;

seepage7‐9fordetails.

3Turntheknobtothel

oworhigh

settingandthenpresstheknob.

Thesettingisselected.

4Turntheknobtochangethesettingvalueandthenpresstheknob

tomakethechangeeffectiveandreturntothescrollingfunction.

Thesettingischanged.

5Tochangetheremainingsetting,repeatsteps3and4.

7‐8MonitoringCO2ExpressionMR200InstructionsforUse

Changing the Unit of Measure

Tochangetheunitofmeasure

CO2 Menu

TheCO2menuallowsyoutocontrolCO2andCO2‐derived

respirationfunctionsandsettings.

TochangesettingsintheCO2menu

Step Action

1TurnthecontrolknobtohighlighttheCO2VSbox(seebelow)and

thenpresstheknob.

TheCO2menuappears.Currentsettingsaredisplayed.

2TurnthecontrolknobtoUNITandthenpresstheknob.

TheUNITmenuappears.Thecurrentsettingishighlighted.

3TurntheknobtoselectoneofthefollowingCO2settings:

mmHg

kPa

Thesettingisselected.

Step Action

1TurnthecontrolknobtohighlighttheCO2VSboxandthenpress

theknob.

TheCO2menuappears.Currentsettingsaredisplayed.

ExpressionMR200InstructionsforUseMonitoringCO27‐9

ALARM LIMITS

ControlsthealarmlimitsettingsforCO2.(WhenSOURCEissettoBELintheRESPmenu,theCO2

respirationalarmlimitsettingswillalsobedisplayed;seepage8‐5.)

2TurnthecontrolknobtoselectanyofthefollowingCO2options

andthenpresstheknob:

ALARMLIMITS

SIZE

GRIDS

ZEROCAL

UNIT

Forinformationabouttheseoptions,seetheappropriatesections

below.

3Turntheknobtothedesiredsettingandthenpresstheknob.

4Tochangeothersettings,repeatsteps2and3.

5PresstheMainkeytoclosethemenu.

Alternative:TurntheknobtoRETURNandthenpresstheknob,or

waitapproximately60seconds.

Definition

1 Is the setting of the high alarm limit

2 Is the current measurement

3 Is the setting of the low alarm limit

4 Saves the settings and returns to the normal mode

5Identifies expired CO2 alarm limits

Step Action

12

3

4

5

7‐10MonitoringCO2ExpressionMR200InstructionsforUse

TosetthealarmlimitsforCO2

SeeChangingtheCO2AlarmLimitsonpage7‐7.

SIZE

SetstheCO2waveformsize.

Thefollowingchoicesareavailable:

•40mmHg(Default)

•60mmHg

•80mmHg

ToadjustthegridsizefortheCO2waveform

EntertheCO2menu.TurnthecontrolknobtoSIZEandpresstheknob.Scrolltothedesiredsize

andpresstheknob.

GRIDS

ControlstheCO2griddisplay.

Thefollowingchoicesareavailable:

•ON

•OFF(Default)

TocontrolCO2griddisplay

EntertheCO2menu.TurnthecontrolknobtoGRIDSandpresstheknob.Scrolltothedesired

settingandpresstheknob.

NOTE

Grids will not be displayed during a CO2 ACCURACY CHECK; see page 11-14.

Grid

Size

ExpressionMR200InstructionsforUseMonitoringCO27‐11

ZERO CAL

Initiatesazerocalibration(anautomaticfunctionduringnormaluse)oftheCO2systemtoallow

forthedifferentcharacteristicsofeachaccessorytype.Themaximumtimerequiredforis

approximately40seconds.

Undercertainconditions,ZEROCALwillnotbeallowed:

•Iflessthan20secondshavepassedsincedetectionofthelastbreath;

•IftheCO2temperatureisunstable;or

•WhenthesamplinglineisdisconnectedfromtheCO2port.

NOTE

ZERO CAL is not required when switching sampling lines.

Toperformazerocalibration

UNIT

SelectstheunitofmeasureusedforpresentationoftheCO2numericdata.

Thefollowingchoicesareavailable:

•mmHg(Default)

•kPa

ToselecttheunitofmeasureforCO2

EntertheCO2menu.TurnthecontrolknobtoUNITandpresstheknob.Scrolltothedesired

settingandpresstheknob.

Step Action

1EnsurethatCO2WARMINGUPisnotdisplayed.

2TurnthecontrolknobtohighlighttheCO2VSboxandthenpress

theknob.

TheCO2menuappears.Currentsettingsaredisplayed.

3TurnthecontrolknobtoselectZEROCALandthenpresstheknob.

PERFORMINGCO2ZEROwillbedisplayedduringcalibration.And

then,whencomplete,themessagewillberemoved.

7‐12MonitoringCO2ExpressionMR200InstructionsforUse

ExpressionMR200InstructionsforUseMonitoringRESP8‐1

CHAPTER 8

Monitoring RESP

IfequippedwiththeCO2option,thepatient’srespirationratewillbecalculatedbymeasuringthe

timeintervalbetweendetectedbreaths.WhenmonitoringrespirationderivedfromCO2,alarm

functionsareprovidedformonitoring.

Respirationratecanalsobemeasuredusingthebellowsdevice;however,alarmfunctionsforthis

methodarenotprovided.

Patient Preparation for RESP Monitoring

Whenpreparingapatient,themonitoringmethodusedwillimpacttheperformanceand

operationoftheRESPparameter.

Monitoring Respiration using CO2

RespirationusingtheCO2parameteriscalculatedbymeasuringthetimeintervalbetween

detectedbreaths;refertochapter7fordetails.

Monitoring Respiration using the Bellows

ThewSPO2moduleandbellowsareintendedforpatientusesasanalternatetoCO2‐derived

respirationwhenrespirationratemeasurementsarerequired.ThewSPO2moduleandbellows

maybeusedintheMRsystembore,althoughthemodulemustnotbeplacedwithintheMRI

fieldofview(FOV).

CAUTION

If dropped, the wSPO2 module must be verified for correct operation before use.

NOTE

Refer to your facility's biohazard procedure for disposal of the bellows when it becomes unusable.

Usually the bellows is disposed of as medical waste per facility procedures.

8‐2MonitoringRESPExpressionMR200InstructionsforUse

Respirationismonitoredbydetectingabdominalorchest

wallmotionusingapneumaticbellowsdevice.Notethat

therearenouseradjustableoptionsoralarmsfor

bellows‐derivedrespirationasitisnotintendedforvital

signmonitoring.

NOTE

If bellows respiration is turned on while the CO2 is on, bellows respiration data will appear in the

RESP VS box and CO2 respiration data will appear in the CO2 VS box.

Bellows Preparation

Respirationmeasurementsthataredeterminedusingthebellowsmethodmakechestwall

expansionveryimportantforaccuratemonitoringofapatient’sbreathing.Iftherespiratory

signalappearstoweakenbetweenscans,instructthepatienttobreathemoredeeplyduringthe

scantocreatemoremovementatthesensorsite.

Topositiontherespiratorysensor

Step Action

1Placethesensoronthepatient’supperabdomenorlowerchest

(whicheverexpandsmostduringinspiration).

2 Afterthepatienthasexhaled,placethevelcrostraparoundthe

patient’strunkandsecurethesensorsnuggly.

3Connecttheflexiblehosetothepneumaticrespirationportonthe

wSPO2module.

4Checkthestatusindicatorofthemodule;seepage2‐8:

• Solidgreen=Batterypowergood/Goodcommunication

• Flashinggreen=Batterypowergood/Nocommunication

• Solidred=Lowbatterypower/Goodcommunication

• Flashingred=Lowbatterypower/Nocommunication

Pneumatic respiration port

Status indicator

ExpressionMR200InstructionsforUseMonitoringRESP8‐3

CAUTIONS

• Avoid excessive bending of the flexible hose, as this will impair detection of the patient’s

respiration.

• Always apply the respiration sensor to the patient prior to connecting to the pneumatic

respiration port on the wSPO2 module. Connecting the pneumatic respiration sensor hose to

the port prior to applying the sensor to the patient can result in damage to the wSPO2

module.

Respiration VS Box

TheelementscontainedintheRESPVSboxaredescribedbelow.

NOTE

CO2-derived respiration is shown in the example below. When bellow-derived respiration is

selected, the related elements and VS box are displayed in white.

5PressthePatientkeyandthenselecttheappropriate

PATIENTtype(seepage3‐10fordetails).

6ChecktherespiratorysignalbeforethepatientisplacedintheMR

system.

7 PositionthepatientintheMRsystem.Ensurethattheflexiblehose

doesnotgetcaught(forexample,betweenthetabletopandthe

patientsupport).

Step Action

Definition

1 Is the high limit setting of the respiration alarm (not present with bellows respiration);

see page 8-5

2 Is the low limit setting of the respiration alarm (not present with bellows respiration);

see page 8-5

1

2

3

4

5

6

8‐4MonitoringRESPExpressionMR200InstructionsforUse

Changing RESP Alarm Limits

TochangetheRESPalarmlimitsettings

NOTE

To make global changes to the parameter alarm limit settings based upon the patient’s current

vital sign readings, see Setting Alarm Limits Globally on page 9-4.

3 Is the unit type for the respiration numeric data, where RPM is respirations per minute

4 Is the source used for the respiration monitoring, where CO2 is CO2-derived, and BEL

is bellows-derived; see page 8-6

5 Is the name of the vital sign/parameter

6 Is the respiration rate measurement (numeric)

Definition

Step Action

1TurnthecontrolknobtohighlighttheRESPVSbox(seepage8‐5)

andthenpresstheknob.

TheRESPmenuappears.Currentsettingsaredisplayed.

2TurnthecontrolknobtoALARMLIMITSandthenpresstheknob.

TheALARMLIMITSmenuappears.Currentsettingsaredisplayed;

seepage8‐5fordetails.

3Turntheknobtothel

oworhigh

settingandthenpresstheknob.

Thesettingisselected.

4Turntheknobtochangethesettingvalueandthenpresstheknob

tomakethechangeeffectiveandreturntothescrollingfunction.

Thesettingischanged.

5Tochangetheremainingsetting,repeatsteps3and4.

ExpressionMR200InstructionsforUseMonitoringRESP8‐5

RESP Menu

TheRESPmenuallowsyoutocontrolrespirationfunctionsandsettings.

TochangesettingsintheRESPmenu

ALARMLIMITS

ControlsthealarmlimitsettingsforCO2‐derivedrespiration.(Seethetableonpage9‐15fora

listing.)

Step Action

1TurnthecontrolknobtohighlighttheRESPVSboxandthenpress

theknob.

TheRESPmenuappears.Currentsettingsaredisplayed.

2TurnthecontrolknobtoselectanyofthefollowingRESPoptions

andthenpresstheknob:

ALARMLIMITS

SOURCE

Forinformationabouttheseoptions,seetheappropriatesections

below.

3Turntheknobtothedesiredsettingandthenpresstheknob.

4Tochangeothersettings,repeatsteps2and3.

5PresstheMainkeytoclosethemenu.

Alternative:TurntheknobtoRETURNandthenpresstheknob,or

waitapproximately60seconds.

8‐6MonitoringRESPExpressionMR200InstructionsforUse

Tosetthealarmlimitsforrespiration

SeeChangingtheRESPAlarmLimitsonpage8‐4.

SOURCE

Selectsthesourceusedtoacquirerespirationmeasurements.

Thefollowingchoicesareavailable:

•CO2calculatestheratebymeasuringthetimeintervalbetweendetectedbreaths.(Default,

whenCO2‐equipped)

•BELcalculatestherateusingapneumaticbellowsthatmeasureschestorabdominal

movement.

Toselectthesourceforrespiration

EntertheRESPmenu.TurnthecontrolknobtoSOURCEandpresstheknob.Scrolltothedesired

sourceandpresstheknob.

Definition

1 Is the setting of the high alarm limit

2 Is the current measurement

3 Is the setting of the low alarm limit

4 Saves the settings and returns to the normal mode

5 Identifies CO2-derived respiration rate alarm limits

1

2

3

4

5

ExpressionMR200InstructionsforUseAlarms9‐1

CHAPTER 9

Alarms

TheMR200alertstheusertophysiological,technicalandstatusalarmswhichmayrequire

attentionorintervention.

Alarm Indications

Activealarmsconsistofbothvisualandaudiblecomponents,wherevisualindicationsare

providedbytheLCDandaudibleindicationsareprovidedbythespeaker.Thealarmtoneisuser‐

adjustablewithatypicalsoundpressurelevelof48–83decibels,andwillsoundafteradelayof

nomorethan4secondsfollowingavisualalarmindication,providedthatthealarmcondition

stillexistsafterthisdelay.

Alarm Safety Information

WARNINGS

• The monitor detects and responds almost immediately to most out-of-limits conditions,

except when averaging of the physiological signal is required to reduce unwanted noise

signals (for example, respiration rates and measurements derived from SPO2 signals.)

• Set the alarm volume based upon the ambient noise levels in the MR environment.

Some areas in the MR environment, such as the MR system room, may have ambient

noise levels louder than the maximum volume of the MR200. Therefore, displayed data

should be continuously monitored. Otherwise, if sound was inaudible, treatment of the

patient could be delayed. For visual alarms, adjust the position of the cart so that you

maintain a clear view of the display.

Status and Technical Alarms

Conditionsorevents(suchaslowbatteriesorhardwareerrors)canresultinalarms,which

generatemessagesthatwillbedisplayedinaparameter’sVSboxand/orinthesystemmessage

areaorthenotificationareaoftheLCD(seepage2‐13).

9‐2AlarmsExpressionMR200InstructionsforUse

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. This will result in the removal of all patient data and displayed information, and a

continuous alarm will sound until power to the MR200 is turned off. If this problem persists,

contact technical support.

Physiological Alarms

Duringmonitoring,ifapatient’svitalsignmeasurementviolatesanactivealarmlimitsetting,a

physiologicalalarmwillbedeclared.Themonitorrespondsbysoundinganalarm(ifenabled)and

byflashingthenumericandwaveform(ifprovided)oftheviolatedparameterinredontheLCD.

Forexample,ifapatient’sheartrateclimbsto71BPM(whichisabovethesettingof60forthe

upperalarmlimitoftheECGvitalsign)analarmconditionisdeclared.

Enabling Print on Alarm

IftheMR200isconnectedtoanIP5printer,youcanautomaticallygenerateaprintoutwhena

physiologicalalarmoccurs.SeetheIP5IFUforsettingdetails.

Definition

1 Violated numeric

2 Violated alarm limit

3 Violated waveform

1

3

2

ExpressionMR200InstructionsforUseAlarms9‐3

Controlling Alarm Indications

WARNINGS

• Always respond promptly to any alarm condition; otherwise, treatment of the patient

could be delayed.

• You should ensure that the current alarm preset is appropriate prior to use on each

patient. Failure to do so may cause a lapse in patient monitoring.

• Setting the alarm limits to extreme values can render alarm monitoring useless. Also,

potential hazard can exist if different alarm monitoring settings are used for the same

or similar equipment in any single patient care unit. Ignoring these restrictions may

cause a lapse in patient monitoring.

TheMR200canbesettoprovidevisualalarmsignalsonly,orbothvisualandaudiblealarm

signals.AllsettingsintheALARMSmenu(exceptALARMSOUND)canbestoredandrecalled.

NOTE

If the MR200 is networked to an IP5, alarm indications occur at both the cart and the IP5; and

control of alarms, including sound level, is localized to the unit (cart or IP5) indicating the alarm

condition.

Latched and Unlatched Alarms

Whenanunlatchedalarmoccurs,thealarmstopswhentheconditionthattriggeredthealarm

ends.Forexample,ifabatterybecomeslow,thealarmendswhenthebatteryisreplaced.The

majorityofMR200alarmsareunlatched.

Ontheotherhand,alatchedalarmcontinuesevenaftertheconditionthatcausedthealarmwas

resolved.LOWPERFisanexampleofalatchedalarm.IfLOWPERFoccursbutthenreturnsto

withinanormalrange,thealarmwillcontinuetodisplaytonotifytheclinicianoftheSPO2event.

(Toclearalatchedalarm,seepage9‐7.)

Showing or Hiding Current Alarm Limits

CurrenthighandlowalarmlimitsaredisplayedintheVSboxofeachmonitoredparameterby

default(exceptbellows‐derivedrespiration).

9‐4AlarmsExpressionMR200InstructionsforUse

Tochangethealarmlimitdisplay

Setting Alarm Limits

WARNING

Alarm limits can be set to a wide range of values, including off. It is the responsibility of the

operator of the MR200 to ensure that alarm limit values appropriate for each patient are

established and set. Failure to do so may cause a lapse in patient monitoring.

TheMR200providesversatilemethodstocontrolthesettingsforthepatientparameteralarms.

Eachpatientparameter(withtheexceptionofbellowsrespiration)hasalowandhighalarmlimit

setting(seethetableonpage9‐14),whichcanbechangedmanuallyorautomatically,unlessthe

parameterisoff.

Setting Alarm Limits Globally

Globalchangescanbemadetoallparameteralarmlimitsettingsbaseduponthepatient’s

currentvitalsignreadingusingCALCULATEALL;seepage9‐10fordetails.Duringthisprocess,ifa

patient’smonitoredvalueissohighorlowthatitwillexceedthealarmlimitrangeforthe

parameter,therespectivealarmlimitwillbesettothehighestorlowestpossiblevalue,butnot

tooff.Forexample,ifafterperformingCALCULATEALL,apatient’sSPO2upperalarmlimitwas

automaticallysetto99(thehighestallowablevalue),thenanalarmwillbegeneratedifthe

patient’sreadingreaches100.Ifyouwanttoturnofftheupperlimit,thenitmustbedone

manually;seeSettingAlarmLimitsIndividuallyonpage9‐5.

AlsonotethatwhenusingCALCULATEALLitwillalmostalwaysresultinalowerSpO2limitthan

thedefaultsetting.ForapatientthathasanSpO2readingof99%thenewupperlimitwillbe99,

butthenewlowerlimitwillbe79(insteadof85)ataCALCULATEALLoffsetof20%(factory

default).

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2WithALARMSETUPhighlighted,pressthecontrolknob.

TheALARMSmenuappears.Currentsettingsaredisplayed.

3TurntheknobtoLIMITSDISPLAYandthenpresstheknob.

4Scrolltothedesiredsettingandpresstheknob.

Thesettingisselected.

ExpressionMR200InstructionsforUseAlarms9‐5

Toadjustthealarmlimitsettingsforallmonitoredparameters

Setting Alarm Limits Individually

IndividualparameteralarmlimitsettingscanbecontrolledintheALARMSmenuorinthe

parameter’smenu(seetheappropriatemonitoringchapterfordetails).

Step Action

1WiththepatientconnectedtotheMR200andwith

thedesiredparametersturnedon,presstheSETUPkey.

TheSETUPmenuappears.

2WithALARMSETUPhighlighted,pressthecontrolknob.

TheALARMSmenuappears.Currentsettingsaredisplayed.

3TurntheknobtoUPPERWINDOWandthenpresstheknob.

Thecurrentsettingishighlighted.

4Scrolltothedesiredpercentageandpresstheknob.Thefollowing

choicesareavailable:

5%

10%

15%

20%

30%

Thesettingisselected.

5TurntheknobtoLOWERWINDOWandthenpresstheknob.

Thecurrentsettingishighlighted.

6Scrolltothedesiredpercentageandpresstheknob.Thefollowing

choicesareavailable:

5%

10%

15%

20%

30%

Thesettingisselected.

7ScrolltoCALCULATEALLthenpresstheknob.

Allactivealarmlimitsettingsarechanged.

9‐6AlarmsExpressionMR200InstructionsforUse

Toadjustthealarmlimitsettingsforasingleparameter(usingtheALARMSmenu)

Restoring Default Alarm Limit Settings

Thesystemautomaticallyrestoresdefaultvalueswhenyouchangethepatienttype.(Seepage9‐

15forthedefaultsettings.)

Torestorethealarmlimitstothedefaultsettings

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2

WithALARMSETUPhighlighted,pressthecontrolknob.

TheALARMSmenuappears.Currentsettingsaredisplayed.

3WithSETINDIVIDUALhighlighted,presstheknob.

Thecursorhighlightsalowalarmlimitsettinginthemenu.

4Turnthecontrolknobtoselectthealarmlimittobechangedand

thenpresstheknob.

Thesettingisselectedandthehighlightingchangescolor.

5Turntheknobtochangethesettingvalueandthenpresstheknob

tomakethechangeeffectiveandreturntothescrollingfunction.

Thesettingischanged.

6Tochangeanyremainingsettings,repeatsteps4and5.

Step Action

1WithamonitoredpatientconnectedtotheMR200,pressthe

SETUPkey.

TheSETUPmenuappears.

2WithALARMSETUPhighlighted,pressthecontrolknob.

TheALARMSmenuappears.Currentsettingsaredisplayed.

3TurntheknobtoDEFAULTLIMITSandpresstheknob.

Thealarmsettingsarereturnedtothedefaultvalues.

ExpressionMR200InstructionsforUseAlarms9‐7

Controlling the Alarm Sound

Thealarmvolumecanbeadjusted.Inaddition,thealarmsoundcanbetemporarilydisabledby

pressingtheSilencekey,oritcanbepermanentlydisabledintheALARMSmenu(althoughthe

numericandwaveformwillcontinuetoflashwhiletheparameterviolatesitsalarmlimit).

Oncesilenced,analarmwillnotsoundagainforanyreasonaslongasthatconditioncontinues.

Onlyadifferentparameterviolationwillcausethealarmsoundtoreactivate.(Forexample,ifa

patient’sheartratedropsbelowthesetlimitandthatalarmissilenced,thealarmwillnotsound

forthatconditionagainunlesstheheartratereturnstowithinlimitsandthendropsbelowthe

limitagain.)

AnactivesilencedalarmmaynotbeaccompaniedbyanALARMSILENCEDmessageor

symboliftheAlarmHoldsequencehasbeenactivated,orifasubsequentalarmhasoccurredand

self‐corrected.

Adjusting the Alarm Volume

Toincreaseordecreasethealarmvolume

Silencing the Alarm

PressingtheSilencekeyduringanalarmwillsilenceallactivealarms,dependinguponthe

TYPEsetting(seepage9‐13):

•IfUNLATCHED,theSilencekeywillmutethealarmsoundand,whiletheviolation

continues,thedisplayednumericandwaveformoftheparameterwillflashinred.Any

newalarmconditionwillcausethealarmtoreactivate.Oncetheparameterreturnsto

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurntheknobtoMONITORSETUPandpressthecontrolknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

3TurntheknobtoSOUNDADJUSTandpresstheknob.

TheSOUNDADJUSTmenuappears.Thecurrentsettingsare

displayed.

4TurntheknobtoALARMVOLUMEandpresstheknob.

1–10(48–83decibels,typical)

Thecurrentsettingishighlighted.Forverificationduring

adjustment,anacknowledgementissoundedattheselectedlevel.

9‐8AlarmsExpressionMR200InstructionsforUse

withinitsalarmlimit,thenumericandwaveformwillstopflashingandreturntotheir

designatedcolor.

•IfLATCHED,whiletheparametercontinuestoviolateitslimit,theSilencekeywillmutethe

alarmsound.Thenumericandwaveformwillcontinuetoflashinredaftertheparameter

returnstowithinitsalarmlimits,thenuponpressingtheSilencekeyasecondtimethe

numericflashingstopsandtheaudiblealarmisplacedintoAlarmHoldmode.

Tosilenceaudiblealarms

PresstheSilencekey.

Alarm Hold Mode

AlarmHoldcanbeusefultotemporarilysilencealarmswhenchangingECGleadsorforotheruser

activitiesthatmightcausea“false”alarm.

AlarmHoldisindicatedwhenisdisplayedandSOUNDONHOLDappearsinthesystem

messageareawithacountdowntimerstartingat120seconds.Theholdperiodisnotuser‐

adjustable.Duringtheholdperiod,theaudiblealarmwillbesuspendedforanynewalarm

conditionsthatoccur.

ToactivateAlarmHold

PresstheSilencekey:

•Ifthealarmisnotsounding,pressingthekeyenablesholdmode.

•Ifthealarmissounding,pressingthekeytwiceenablesholdmode.

Aftertheholdperiodexpires,thesoundforthephysiologicalalarmsarerestored.Alarm

conditionspreviouslysilencedbypressingtheSilencekeywillnottriggeranaudiblealarmwhen

theholdperiodtimesout.

TodeactivateAlarmHold

•Waituntilthecountdowncompletes;or,

•PresstheSilencekey.

ALARMS Menu

TheALARMSETUPoption(intheSETUPmenu)openstheALARMSmenu,whichcontains

optionsforsetupandcontrolofthevitalsignalarms.

ExpressionMR200InstructionsforUseAlarms9‐9

TochangesettingsintheALARMSmenu

Setup key

Control knob

ALARMS

menu

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2

WithALARMSETUPhighlighted,pressthecontrolknob.

TheALARMSmenuappears.Currentsettingsaredisplayed.

3Turnthecontrolknobtoselectanyofthefollowingsystem‐wideor

individualalarmoptionsandthenpresstheknob:

SETINDIVIDUAL

CALCULATEALL

UPPERWINDOW

LOWERWINDOW

ALARMSOUND

DEFAULTLIMITS

TYPE

LIMITSDISPLAY

Forinformationabouttheseoptions,seetheappropriatesections

below.

4Turntheknobtothedesiredsettingandthenpresstheknob.

9‐10AlarmsExpressionMR200InstructionsforUse

SET INDIVIDUAL

Controlsthealarmlimitsettingsforindividualparameters.

Toindividuallyadjustthealarmlimitsettings

Seepage9‐5.

CALCULATE ALL

CalculatesnewalarmlimitsettingsforallactiveparametersaccordingtothesettingsinUPPER

WINDOWandLOWERWINDOWoptions(seebelow).Correspondinglowandhighcalculations

willbeperformedforeachactiveparameter.

5Tochangeotheroptions,repeatsteps3and4.

6PresstheMainkeytoclosethemenu.

Alternative:TurntheknobtoRETURNandthenpresstheknob,or

waitapproximately60seconds.

Definition

1 Identifies the parameter

2 Are the current settings of the low alarm limits

3 Are the current readings of the patient

4 Are the current settings of the high alarm limits

5 Exits the menu

Step Action

1234

5

ExpressionMR200InstructionsforUseAlarms9‐11

Togloballyadjustthelowandhighalarmlimitsettings

SeeSettingAlarmLimitsGloballyonpage9‐4.

NOTE

If a patient’s monitored value is so high or low that it exceeds the alarm limit range for the

parameter, the respective alarm limit will be set to the highest or lowest possible value, but not to

off, as indicated in the table on page 9-14.

UPPER WINDOW

SetsapercentvalueusedtocalculatethehighalarmlimitswhenCALCULATEALLisselected.The

currentparametervalueisbracketedwiththepercentagessetinthismenuandtheLOWER

WINDOWsetting.

Thefollowingchoicesareavailable:

•5%

•10%

•15%

•20%(Default)

•30%

Tosettheuppercalculationvalue

EntertheALARMSmenu.TurnthecontrolknobtoUPPERWINDOWandpresstheknob.Scrollto

thedesiredpercentageandpresstheknob.

LOWER WINDOW

SetsapercentvalueusedtocalculatethelowalarmlimitswhenCALCULATEALLisselected.The

currentparametervalueisbracketedwiththepercentagessetinthismenuandtheUPPER

WINDOWsetting.

Thefollowingchoicesareavailable:

•5%

•10%

•15%

•20%(Default)

•30%

Tosetthelowercalculationvalue

9‐12AlarmsExpressionMR200InstructionsforUse

EntertheALARMSmenu.TurnthecontrolknobtoLOWERWINDOWandpresstheknob.Scroll

tothedesiredpercentageandpresstheknob.

ALARM SOUND

WARNING

The alarm sound can be turned off. Always ensure that the alarm sound setting is

appropriate for each patient. The alarm sound volume is adjustable for suitability to various

clinical environments. When you use the MR200, always ensure that the alarm sound can be

heard above the ambient noise level. Failure to do so may cause a lapse in patient

monitoring.

Controlstheaudioalertforthealarms(identicaltoandinteractivewithMONITOR>SOUND

ADJUST>ALARMS;seepage3‐8).

Thefollowingchoicesareavailable:

•ONturnsonthealarmsound,whereindicatesthatthesoundhasbeenenabled.

(Default)

•OFFturnsoffthealarmsound,whereindicatesthatthesoundhasbeendisabled.

(Onlythealarmsoundwillbedisabled;thevisualalertfromthesourceoftheviolationstill

flashesinred.)

Tosetthealarmsound

DEFAULT LIMITS

Automaticallysetsthelowandhighalarmlimitsforallparameterstothealarmlimitdefaults

(seethetableonpage9‐15).

Tosetthealarmlimitsettingstothedefaultlimits

SeeRestoringDefaultAlarmLimitSettingsonpage9‐6.

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2

WithALARMSETUPhighlighted,pressthecontrolknob.

TheALARMSmenuappears.Currentsettingsaredisplayed.

3TurnthecontrolknobtoALARMSOUNDandthenpresstheknob:

4Turntheknobtothedesiredsettingandthenpresstheknob.

ExpressionMR200InstructionsforUseAlarms9‐13

TYPE

DeterminestheresponseofanalarmwhentheSilencekeyispressed.

Thefollowingchoicesareavailable:

•UNLATCHEDalarmsceaseaudioandvisualalertsiftheviolatedparameterreturnswithin

itslimitsoriftheSilencekeyispressed.(Default)

•LATCHEDalarmsceaseaudioandvisualalertsonlywhentheSilencekeyispressed.

Tosetthetypeofthealarm

EntertheALARMSmenu.TurnthecontrolknobtoTYPEandpresstheknob.Scrolltothedesired

settingandpresstheknob.

LIMITS DISPLAY

DeterminesifthealarmlimitsettingsareshownintheVSboxes.

Thefollowingchoicesareavailable:

•ONdisplaysthealarmlimitsettings.(Default)

•OFFhidesthealarmlimitsettings.

Tocontrolthepresenceofthealarmlimitsettings

EntertheALARMSmenu.TurnthecontrolknobtoLIMITSDISPLAYandpresstheknob.Scrollto

thedesiredsettingandpresstheknob.

Testing Alarms

Toverifythatthealarmsystemisworking

Step Action

1Withthemonitorturnedonandnotinsuspendmode,makesureall

alarmsareenabled(ALARMSOUNDisnotoff,silenced,oronhold).

2MakesurethelowerSPO2alarmlimitisnotsettoOFF.

9‐14AlarmsExpressionMR200InstructionsforUse

NOTE

If a problem with the alarm sound or messaging system is suspected, discontinue use of the

MR200 and refer it to authorized service personnel for evaluation.

Adjustable Alarm Limit Ranges

Withtheexceptionofbellowsrespiration,eachparameteralarmhasadjustablelimitsasindicatedin

tablebelow

.

TheMR200preventscrossoveroflowandhighalarmlimitsettings;and,ifaparameter

hasbeenturnedoff,itsalarmlimitswillbeoff.

3VerifythewSPO2modulestatusbycheckingthestatusindicator:

• Solidgreen=BatterypowerOK/Goodcommunication

• Flashinggreen=BatterypowerOK/Nocommunication

• Solidred=Lowbatterypower/Goodcommunication

• Flashingred=Lowbatterypower/Nocommunication

4PlacetheSPO2attachmentonyourfingerandwaitforavalueto

appearintheSPO2VSbox.

5 Removetheclipfromyourfinger.

6

EnsurethattheNON‐PULSATorPROBEOFFmessageappearsin

theSPO2VSbox,thewaveformflatlinesandturnsred,the

numericflashesinred,andthealarmtonesounds.

Step Action

Adjustable Alarm Limit Ranges

Vital Sign or

Parameter Unit Low Alarm Limit * High Alarm Limit *

Minimum Maximum Minimum Maximum

Heart Rate BPM Off, 30 249 60 249, Off

CO2 (End-tidal)** mmHg

kPa

Off, 5

Off, 0.7

60

8.0

5

0.7

80, Off

10.7, Off

CO2 Respiration RPM Off, 4 40 20 99, Off

NiBP Systolic, Adult mmHg

kPa

Off, 46

Off, 6.1

254

33.9

46

6.1

254, Off

33.9, Off

NiBP Systolic, Pediatric mmHg

kPa

Off, 46

Off, 6.1

254

33.9

46

6.1

254, Off

33.9, Off

NiBP Systolic, Neonate mmHg

kPa

Off, 46

Off, 6.1

124

16.5

46

6.1

124, Off

16.5, Off

ExpressionMR200InstructionsforUseAlarms9‐15

*Allow±oneleastsignificantdigittoaccommodatetheround‐offerrorforcalculatedvalues.

**HighalarmlimitforinspiredCO2isfixed.

Alarm Limit Defaults

Intheeventofpowerloss,anyalarmlimitsettingsthatwerechangedwillbelost.Allsettingsthat

mayhavebeenmodifiedtosuitaparticularpatientshouldbeconfirmedbeforemonitoring.

Atpowerup,theMR200willautomaticallysetallalarmlimitsasdeterminedbythesettinginthe

DEFAULTSETUPSmenu;seepage3‐13.

NiBP Mean, Adult mmHg

kPa

Off, 26

Off, 3.5

239

31.9

26

3.5

239, Off

31.9, Off

NiBP Mean, Pediatric mmHg

kPa

Off, 26

Off, 3.5

239

31.9

26

3.5

239, Off

31.9, Off

NiBP Mean, Neonate mmHg

kPa

Off, 26

Off, 3.5

94

12.5

26

3.5

94, Off

12.5, Off

NiBP Diastolic, Adult mmHg

kPa

Off, 16

Off, 2.1

224

29.9

16

2.1

224, Off

29.9, Off

NiBP Diastolic, Pediatric mmHg

kPa

Off, 16

Off, 2.1

224

29.9

16

2.1

224, Off

29.9, Off

NiBP Diastolic, Neonate mmHg

kPa

Off, 16

Off, 2.1

84

11.2

16

2.1

84, Off

11.2, Off

SPO2 Percent Off, 50 99 70 99, Off

Adjustable Alarm Limit Ranges

Vital Sign or

Parameter Unit Low Alarm Limit * High Alarm Limit *

Minimum Maximum Minimum Maximum

Factory Default Alarm Limits*

Vital Sign or

Parameter Unit

Neonate Pediatric Adult

Low

Limit

High

Limit

Low

Limit

High

Limit

Low

Limit

High

Limit

Heart Rate BPM 90 210 75 160 45 160

CO2 (End-tidal) mmHg

kPa

30

4.0

45

6.0

15

2.0

60

8.0

15

2.0

60

8.0

CO2 Respiration RPM 30 70 4 40 4 40

NiBP Systolic mmHg

kPa

70

9.3

100

13.3

70

9.3

120

16.0

65

8.7

190

25.3

NiBP Mean mmHg

kPa

40

5.3

90

12.0

50

6.7

90

12.0

55

7.3

135

18.0

9‐16AlarmsExpressionMR200InstructionsforUse

*Allow±oneleastsignificantdigittoaccommodatetheround‐offerrorforcalculatedvalues.

Listing of Alarms

Allalarmsarecategorizedashighpriority.

WARNING

If, during use, an alarm condition listed below results in a loss of patient monitoring

capability, employ an alternate means as needed to prevent a lapse in patient monitoring;

otherwise, treatment of the patient could be delayed.

NOTE

In the tables below, abbreviations used in the Type column have these meanings:

C = conditional; L = latched; S = selectable; and, U = unlatched.

Status and Technical Alarm Indications and Messages

Thefollowingtablecontainsalistingofthestatusandtechnicalalarmindicationsandmessages.

NiBP Diastolic mmHg

kPa

35

4.7

50

6.7

40

5.3

70

9.3

40

5.3

125

16.7

SPO2 Percent 90 Off 90 Off 85 Off

Factory Default Alarm Limits*

Vital Sign or

Parameter Unit

Neonate Pediatric Adult

Low

Limit

High

Limit

Low

Limit

High

Limit

Low

Limit

High

Limit

Displayed Message/

Indication

Message

Location Type Probable Cause Recommended Action

ALARM SILENCED System message

area

NOTE

No alarm sound

generated

U The Silence key was

pressed.

Wait until the 120-second countdown

completes or press the Silence key.

BAD PROBE SPO2 VS box U The SPO2 sensor is

defective.

Replace the SPO2 sensor.

ExpressionMR200InstructionsforUseAlarms9‐17

CHANGE NiBP CUFF Notification

area

L The PATIENT type was

changed and this message is

displayed as a reminder.

Ensure the correct cuff size is used for

the patient.

CHECK ALARM VOL System message

area

U Power was just turned on,

settings were recalled, or an

adjustment was made to a

sound setting

No action necessary. Allow the process

to complete.

CHECK CO2

SAMPLING LINE

Notification

area

U Reduced flow has been

detected by the CO2 system.

Check for pinches or obstructions in

the sampling line. Clear any pinch, or

replace the accessory if necessary.

COMM ERR NiBP VS box L NiBP internal error Discontinue use of NiBP and contact

technical support.

CO2 CAL FAIL Notification

area

CCO2 calibration has failed. Retry calibration. If the problem

persists, contact technical support.

CO2 Hardware Fail Notification

area

CCO2 module was not found

during initialization

Contact technical support.

CO2 OUT OF RANGE Notification

area

U The calculation value is greater

than the upper CO2 limit .

Perform patient readings to confirm

physiological condition.

CO2 SENSOR FAULTY Notification

area

LCO2 bench detected a

hardware or sensor error.

Contact technical support.

CO2 SENSOR OVER

TEMP

Notification

area

UCO2 sensor is above the

specified operating

temperature.

Confirm that the MR200 is operating

within required environmental

conditions (see Appendix A). If outside

the specified range, move the cart to an

area that is within limits.

If the problem persists, stop all

monitoring activities and contact

technical support.

CO2 WARMING UP Notification

area

UDisplayed during the warm-up

period of the CO2 module

Allow the module to complete its

warm-up cycle, about two minutes.

CO2 ZERO REQUIRED Notification

area

U Zero calibration of the CO2

module is needed

Perform a zero calibration; see page 7-

11.

DEFL TO NiBP VS box L NiBP deflation has timed out. • Check the patient.

• Check for proper cuff size and

placement.

• Check the cuff and hoses for

pinching.

• If the message persists, contact

technical support.

ERRATIC SPO2 VS box U The SPO2 clip (or grip) is not

properly applied to the

patient, is not properly

positioned, or the sensor is

faulty.

• Check the alignment of the clip (or

grip).

• Replace the SPO2 sensor.

• If the message persists, contact

technical support.

HW ERR NiBP VS box L NiBP hardware failure Discontinue use of NiBP and contact

technical support.

Displayed Message/

Indication

Message

Location Type Probable Cause Recommended Action

9‐18AlarmsExpressionMR200InstructionsforUse

HW FAIL NiBP VS box L A hardware or other error

has occurred in the NiBP

system.

Discontinue use of NiBP and contact

technical support.

HW FAIL SPO2 VS box L A hardware or other error

has occurred in the wSPO2

module.

Replace the wSPO2 module. If the

failure persists, immediately remove

the MR200 and wSPO2 module from

service and contact technical support,

as the system must not be used on any

patient requiring SPO2 measurement.

INFL TO NiBP VS box L NiBP inflation has timed out. • Check the patient.

• Check the cuff and hoses for

pinching or leaks.

• If the message persists, contact

technical support.

Internal CO2 Occlusion Notification

area

U The internal filter has become

polluted or disconnected.

Contact technical support.

INTRFERNCE SPO2 VS box U Interference due to

misalignment of the

attachment’s light source and

receiver, or incorrect

positioning of the attachment

on the patient.

• Ensure that the module is placed

outside of the MR bore.

• Reposition the wSPO2 module (see

page 5-5.

• Check the alignment of the clip (or

grip).

• Try a different limb or site.

• Replace the clip (or grip).

LEAD FAIL ECG trace

area

NOTE

If the heart

rate source is

set to ECG, no

HR value will

be displayed in

the ECG VS

box.

U A faulty or disconnected

ECG lead is detected.

NOTES

An inoperative ECG

parameter or wECG module

is indicated by absence of an

ECG waveform and a

simultaneous Lead Fail

alarm.

Ensure all clip leads are connected to

the Quadtrode electrode and that the

ECG lead cable is properly connected

to the wECG module. Also, ensure

that the wECG module has sufficient

battery power.

If the problem persists, replace the

ECG lead cable.

Displayed Message/

Indication

Message

Location Type Probable Cause Recommended Action

ExpressionMR200InstructionsforUseAlarms9‐19

LEAD SATURATION ECG trace

area

NOTE

If the heart

rate source is

set to ECG, no

HR value will

be displayed in

the ECG VS

box.

U Reported within 10 seconds,

the baseline offset of the ECG

input signal is too large for the

system to process and display

the waveform.

Replace the Quadtrode electrode.

LOW PERF SPO2 VS box

NOTE

No alarm

sound

generated

U Accuracy may be

compromised due to low

perfusion. The tissue at the

site may be too opaque, thick

or cold.

• If the attachment is positioned on

the finger, check the fingernails for

nail polish, long or artificial

fingernails. Remove any fingernail

polish completely.

• Try another location, like a toe.

• Try rubbing or warming the limb.

Module Not Calibrated NiBP VS box L NiBP is not calibrated. Contact technical support.

MSMT FAIL NiBP VS box L The NiBP measurement has

failed.

• Check the patient.

• Check for proper cuff size and

placement.

• Check the cuff and hoses for

pinching or leaks.

• If the message persists, contact

technical support.

MSMT TO NiBP VS box L The NiBP measurement has

timed out.

• Check the patient.

• Check for proper cuff size and

placement.

• Check the cuff and hoses for

pinching or leaks.

• If the message persists, contact

technical support.

NiBP:

COMMUNICATION

ERROR

Notification

area L

Same as COMM ERR See COMM ERR for details.

NiBP: DEFLATION

TIMEOUT

Notification

area

L Same as DEFL TO See DEFL TO for details.

NiBP: HARDWARE

ERROR

Notification

area

L Same as HW ERR See HW ERR for details.

NiBP: INFLATION

TIMEOUT

Notification

area

L Same as INFL TO See INFL TO for details.

Displayed Message/

Indication

Message

Location Type Probable Cause Recommended Action

9‐20AlarmsExpressionMR200InstructionsforUse

NiBP: MEASUREMENT

FAILED

Notification

area

L Same as MSMT FAIL See MSMT FAIL for details.

NiBP: MEASUREMENT

TIMEOUT

Notification

area

L Same as MSMT TO See MSMT TO for details.

NiBP: OVER

PRESSURE

Notification

area

L Same as OVR PRESS See OVR PRESS for details.

NiBP: PRESSURE

CORRECTION ERROR

Notification

area

L Same as PRESS CORR See PRESS CORR for details.

NiBP: RESIDUAL

PRESSURE

Notification

area

L Same as RESID PRESS.See RESID PRESS for details.

NO PROBE SPO2 VS box U The SPO2 sensor is not

present or is improperly

connected to the wSPO2

module.

Check the connection of the sensor to

the module. Reconnect it; or if the

connection is good, replace the sensor.

NOISE SPO2 VS box U Excessive patient motion;

MRI scan sequence; or,

electrical interference is

being experienced by the

SPO2 system.

• Check for patient motion, especially

at the monitored site.

• Ensure that the module is placed

outside of the MR bore.

• Ensure the clip (or grip) is

positioned so that it is not exposed

to excessive levels of ambient light.

NON-PULSAT SPO2 VS box U The patient’s pulse is too

weak for the system to

report reliable SPO2

saturation and pulse

measurements.

• Check the patient’s condition.

• Check the clip (or grip) position and

alignment on the patient then re-

position or re-apply as necessary

• Try a different limb or site.

OVERSCALE ECG trace

area

NOTE

No alarm

sound

generated

UThe ECG waveform is too

large and the peaks are being

clipped.

Reduce the waveform size by choosing

a setting in the ECG Scale menu.

OVR PRESS NiBP VS box L NiBP has exceeded the

allowed pressure for the

patient type.

• Ensure that the patient is

immobilized and not applying

pressure to the cuff.

• Check the cuff condition and

placement on the patient.

• Make sure that the hose is not

pinched.

• If the message persists, contact

technical support.

Displayed Message/

Indication

Message

Location Type Probable Cause Recommended Action

ExpressionMR200InstructionsforUseAlarms9‐21

PERFORMING CO2

ZERO

Notification

area

UDisplayed while performing

CO2 zeroing.

No action necessary. Allow the process

to complete.

PRESS CORR NiBP VS box L An NiBP pressure correction

error has been detected.

• Ensure that the patient is

immobilized and not applying

pressure to the cuff.

• Check the cuff condition and

placement on the patient.

PROBE OFF SPO2 VS box

NOTE

Alarm sounds

only if

reported after

a valid

numeric is

displayed.

U The SPO2 attachment is not

properly applied to the

patient.

Check the position of the clip (or grip)

and its alignment on the patient;

reposition or reapply the clip (or grip).

PULSE? SPO2 VS box U The clip (or grip) may not be

applied optimally; or, the

tissue at the application site

may be too opaque.

• Check the alignment of the clip (or

grip).

• Try a different limb or site.

RESID PRESS NiBP VS box L Residual pressure remains in

the NiBP system.

Disconnect the NiBP hose and restart

the procedure.

REAL TONES

DISABLED Notification

area

NOTE

No alarm

sound

generated

U Displayed when in the

SOUND ADJUST >

ALARMS menu

Exit the menu.

SEARCHING SPO2 VS box

NOTE

Alarm sounds

only if

reported after

a valid

numeric is

displayed.

U The SPO2 attachment was

just applied to the patient or

it has shifted position since

attachment.

• If SPO2 was just applied, allow

about 20 seconds for the system to

lock on to a good pulse.

• Check the clip (or grip) position and

reposition it if necessary.

• Replace the SPO2 sensor.

• If the message persists, contact

technical support.

Displayed Message/

Indication

Message

Location Type Probable Cause Recommended Action

9‐22AlarmsExpressionMR200InstructionsforUse

SIMULATION System message

area

NOTE

No alarm sound

generated

L Simulation mode is running. Cycle power off and on.

SOUND ON HOLD System message

area

NOTE

No alarm sound

generated

U Power was turned on, or the

Silence key was pressed.

Wait until the 120-second countdown

completes or press the Silence key.

SUSPENDED System message

area

NOTE

No alarm sound

generated

U The Suspend key was

pressed and alarms are now

suspended.

Press the Suspend key to exit the

mode.

WARNING

Move monitor away

from magnet. NiBP

and CO2 (if installed)

have been shut down.

Dialog box U The gauss limit has been

exceeded, and now NiBP and

CO2 can no longer function.

Position the MR200 per the product

labeling; see page 2-6.

WARNING

Persistent CO2

occlusion detected.

Please clear occlusion

and press OK to

resume using CO2

Dialog box U Reduced flow has been

detected by the CO2 system

for over 2 minutes.

Check for pinches or obstructions in

the sampling line. Clear any pinch, or

replace the accessory if necessary.

Afterward, press OK to restart the

CO2 parameter.

If the message persists, contact technical

support.

WRONG PRB SPO2 VS box U The SPO2 sensor connected

to the wSPO2 module is not

the correct type.

Attach the correct sensor to the

module.

Communication

and power

status display

area

U No communication between

the cart and wSPO2 module

Ensure that the wSPO2 module is set to

the same network channel as the cart. If

both are the same, use an alternate

setting.

If the indication persists, contact

technical support.

Displayed Message/

Indication

Message

Location Type Probable Cause Recommended Action

ExpressionMR200InstructionsforUseAlarms9‐23

Physiological Alarm Indications and Messages

Thefollowingtablecontainsanalphabeticallistingofphysiologicalalarmindicationsand

messages.

Communication

and power

status display

area

U No communication between

the cart and wECG module

Ensure that the wECG module is set to

the same network channel as the cart. If

both are the same, use an alternate

setting.

If the indication persists, contact

technical support.

Communication

and power

status display

area

U Low cart battery Connect the cart to external power and

allow the batteries to charge.

Communication

and power

status display

area

U

Low module battery Install a charged battery into the

module.

Displayed Message/

Indication

Message

Location Type Probable Cause Recommended Action

Displayed Message/

Indication

Message

Location Type Probable Cause Recommended Action

Red flashing VS numeric, and

waveform (if applicable)

VS box of

associated

parameter

S Alarm limit violation Check the patient.

- - -

VS box of

associated

parameter

NOTE

Alarm sounds

only if reported

after a valid

numeric is

displayed.

U Parameter data once present

is no longer available or a

hardware failure has occurred.

If occurring in the NiBP VS

box, may indicate the

measurement is out of range.

If an alarm was generated:

• Ensure that the wireless modules are

still communicating; see page 2-16

for status indications.

• Ensure that all patient attachments

are still connected.

• A parameter’s hardware may have

experienced a problem; contact

technical support.

• Perform patient readings to confirm

physiological condition.

If no alarm was generated:

• Allow a few seconds for the system

to complete its processes.

• A measurement value may be

distorted or the signal may be

inadequate; recheck all patient

connections.

9‐24AlarmsExpressionMR200InstructionsforUse

OVR ECG or SPO2

VS box

(Replaces the

numeric,

except for

ECG, which

will alternate

with a numeric

value that is

more than the

highest

specified heart

rate.)

U The heart rate measurement

was greater than the upper

measurement range of the

parameter

Check the patient.

If the indication persists, contact

technical support.

UND ECG or SPO2

VS box

(Replaces the

numeric,

except for

ECG, which

will alternate

with a numeric

value that is

less than the

lowest

specified heart

rate.)

U The heart rate measurement

was less than the lower

measurement range of the

parameter

Check the patient.

If the indication persists, contact

technical support.

Displayed Message/

Indication

Message

Location Type Probable Cause Recommended Action

ExpressionMR200InstructionsforUseTrendDataandPrinting10‐1

CHAPTER 10

Trend Data and Printing

Trend Data

Thetrendfeature,accessedusingtheTRENDSkey,providesoptionsthatincludetabular

andgraphicaltrendsreportingandtrendarrowindications.Trenddataisusefulforassessinga

patientoveraperiodoftime.Thetrenddatacapturesthefollowinginformation:

•Timeanddateatwhicheachsetofmeasurementswasrecorded

•Heartratevalueandsource

•NiBP

•SPO2

•CO2

•CO2‐derivedrespiration

Trenddataisstoredfromthetimeyoubeginmonitoringandcontinuesuntilthedataiscleared

orthemonitoristurnedoff.Allstoredtrenddata,withtheexceptionoftabulartrenddata,will

belostifpowerisremoved.Trenddatacandisplayedinaselectableformatandinterval.

Tabular Trend Data

Tabulartrenddataisprovidedonapagelayout.

1

3

6

7

8

10 9

2

4

5

10‐2TrendDataandPrinting ExpressionMR200InstructionsforUse

Viewing Multi-Parameter Tabular Trend Data

Toviewtabulartrenddataformultipleparameters

Graphical Trend Data

Graphicaltrenddataisplottedonameasuredvalueversustimescale.Upto24hoursof

graphicaltrenddatacanbestored.After24hours,theoldestdataisdeletedtomakeroomfor

newerdata.

Definition

1 Is the name of the dialog

2 Are the CO2-derived respiration readings

3 Are the CO2 readings

4 Are the SPO2 readings

5 Are the heart rate readings

6 Is the page number, displayed oldest (first) to newest (last)

7 Are the NiBP mean readings

8 Are the NiBP systolic/diastolic readings

9 Is the time of the reading

10 Is the date of the reading

Step Action

1PresstheTRENDSkey(whileinthenormalmode).

TheHISTORYmenuappearsandthefirstpageoftrenddataare

displayed.

2Turnthecontrolknobtoselectanyofthefollowingoptionsand

thenpresstheknob:

PREVPAGE

NEXTPAGE

Forinformationabouttheseoptionsandsettings,seethe

appropriatesectionsbelow.

3Toviewotherpages,repeatstep2.

ExpressionMR200InstructionsforUseTrendDataandPrinting10‐3

Viewing Individual Trend Graphical Data

Toviewgraphicaltrenddataforasingleparameter

RotatethecontrolknobtohighlighttheVSboxofthedesiredparameterandthenpressthe

TRENDSkey.

Definition

1 Is the name of the graph

2 Are the numeric values of the selected parameters (y-axes) and

plotted in the same color

3 Are the selected parameters (y-axis labels)

4Is the y-axis plot

5Is the plot grid

6 Is the x-axis plot

1

3

6

2

4

5

2

3

4

10‐4TrendDataandPrinting ExpressionMR200InstructionsforUse

Viewing Multi Trend Graphical Data

Toviewgraphicaltrenddataformultipleparameters

Step Action

1PresstheTRENDSkey(whileinthenormalmode).

TheHISTORYmenuappearsandthefirstpageoftrenddataare

displayed.

2TurnthecontrolknobtoMULTITRENDSandthenpresstheknob.

TheMULTITRENDSsubmenuappears.

3TurnthecontrolknobtoSELECTandthenpresstheknobtochoose

theparametersusedintheplot.

4Turnthecontrolknobtoselectanyofthefollowingparameters

thenpresstheknobtoselecttheparameter.

HR

NiBP

SPO2

ETCO2

RESP[CO2]

Thiswillformthey‐axisoftheplot.

5Ifdesired,repeatstep4toselectadditionalparameters(uptofour

canbeplottedsimultaneously).Thenturnthecontrolknobto

RETURNandpresstheknob.

6TurnthecontrolknobtoTIMEBASEandthenpresstheknobtoset

thetimebaseusedfortheplot.

7Turnthecontrolknobtoselectoneofthefollowingintervalsand

thenpresstheknob.

20SEC

2HOURS

4HOURS

8HOURS

24HOURS

Thiswillbethex‐axisoftheplot.

8TurnthecontrolknobtoMENUBACKandthenpresstheknobto

positionthemenubehindthegraphforunobstructedviewing.

9TurnthecontrolknobtoCURSOR/ZOOMandthenpresstheknob

toexamineindividualpointsintime.

10 Whilethecursorisinthemostrightsideoftheplot,presstheknob

againtoexitthezoomfunction.

11 PresstheMainkeytoexitthemenu.

ExpressionMR200InstructionsforUseTrendDataandPrinting10‐5

HISTORY Menu

TheHISTORYmenuprovidesoptionstoselectpages.Upto48trend

recordscanbestored.Ahistoryfilecanbeviewedforallparameters.The

elementscontainedinthehistoryfilepagearedescribedbelow.

TochangesettingsintheHISTORYmenu

Step Action

1

PresstheTRENDSkey(whileinthenormalmode).

TheHISTORYmenuappears.Currentsettingsaredisplayed.

2Turnthecontrolknobtoselectanyofthefollowingoptionsand

thenpresstheknob:

PREVPAGE

NEXTPAGE

CLEARALL

MULTITRENDS

TRENDARROWS

ARROWPERIOD

Forinformationabouttheseoptions,seetheappropriatesections

below.

3Turntheknobtothedesiredsettingoritemandthenpressthe

knob.

4IfMULTITRENDSwasselected,gotostep5;otherwise,gotostep

7.

5Turnthecontrolknobtoselectanyofthefollowingoptionsand

thenpresstheknob:

SELECT

CURSOR/ZOOM

TIMEBASE

CLEARALL

TRENDARROWS

MENUBACK

Forinformationabouttheseoptions,seeMULTITRENDS,below.

6Turntheknobtothedesiredsettingoritemandthenpressthe

knob.

10‐6TrendDataandPrinting ExpressionMR200InstructionsforUse

Todisplaythepreviouspageofthehistoryfile

SeeViewingMulti‐ParameterTabularTrendDataonpage10‐2fordetails.

Todisplaythenextpageofthehistoryfile

SeeViewingMulti‐ParameterTabularTrendDataonpage10‐2fordetails.

CLEAR ALL

Removesalltrenddata.Astrenddataisretainedwhena

newpatientisconnectedformonitoring,toavoidconfusion,

allpreviouslyacquireddatashouldbeclearedpriorto

connectionofanewpatient.

Beforedataerasure,adialogboxwillpromptyoufor

confirmation.Usethecontrolknobtohighlightthedesired

actionandthenpresstheknobtoproceed.

Toclearalltrenddata

PresstheTRENDSkey.TurnthecontrolknobtoCLEARALLandpresstheknob.

7PresstheMainkeytoclosethemenu.

Alternative:TurntheknobtoRETURNandthenpresstheknob,or

waitapproximately60seconds.

Step Action

ExpressionMR200InstructionsforUseTrendDataandPrinting10‐7

MULTI TRENDS

Displaysagraphicalrepresentationofselectedmonitoredparameters.

Thefollowingchoicesareavailable:

•SELECTconfiguresuptofoursimultaneoustrendsusedtoplotthey‐axisofthegraph.

Thefollowingchoicesareavailable:

–HRplotsheartrate

–NiBPplotsNiBP

–SPO2plotsSPO2

–ETCO2

plotsEtCO2

–RESP[CO2]plotsCO2‐derivedrespiration

•CURSOR/ZOOMzoomsintothetrendchart,openingawindowwhereindividualpointsin

timecanbeviewed.(Toexitthisfeature,turnthecontrolknobuntiltheverticallineisas

fartotherightaspossibleandthenpresstheknob.)

•TIMEBASEconfigurestheintervalusedtoplotthex‐axisofthegraph.

Thefollowingchoicesareavailable:

–20SEC(Default)

–2HOURS

–4HOURS

–8HOURS

–24HOURS

•CLEARALLdeletesalldatafromthetrendhistory.

•MENUBACKmovesthemenubehindthegraphwindow.

TodisplaytheMultiTrendsgraphandsubmenu

PresstheTRENDSkey.TurnthecontrolknobtoMULTITRENDSandpresstheknob.

10‐8TrendDataandPrinting ExpressionMR200InstructionsforUse

TREND ARROWS

Controlsavitalsigntrendindication,whereatrendarrowisdisplayedalongsidetheVSbox(not

availableforbellows‐derivedrespiration)withameaningasdefinedinthetablebelow.(See

page2‐14foranexample.)

Thefollowingchoicesareavailable:

•ONturnsonthetrendarrows.

•OFFturnsoffthetrendarrows.(Default)

Todisplaytrendarrows

PresstheTRENDSkey.TurnthecontrolknobtoTRENDARROWSandpresstheknob.Thenturn

thecontrolknobtoON.

WARNING

Depending upon the ARROW PERIOD and measurement cycles of the vital signs, NiBP

trend arrow indications may not be representative of the current condition of the patient.

ARROW PERIOD

Setsthetimeusedtocalculateanddeclarethedirectionforthetrendarrows.

Thefollowingchoicesareavailable:

•30SEC

•1MIN

•3MIN(Default)

•5MIN

•10MIN

Tosetthearrowperiod

PresstheTRENDSkey.TurnthecontrolknobtoARROWPERIODandpresstheknob.Thenturn

thecontrolknobtothedesiredinterval.

Indication Meaning

Rising

Declining

Stable

None declared

ExpressionMR200InstructionsforUseTrendDataandPrinting10‐9

NOTE

If a newly selected period is shorter than the previous period (and the arrows have been on for the

longer of the two periods) then immediate recalculation using the new period will occur.

Alternately, if the newly selected period is longer than the previous period, recalculation will occur

using all available data.

Print Functions

WhenequippedwithanIP5printer,theMR200canprovidesingleordualwaveformstripcharts.

NOTES

• If a printer-equipped IP5 is not installed or connected to the system, will be displayed

in the communication and power status display area on the LCD. For a listing of printer

icons, see page 2-16.

• Any print command from the MR200 automatically initiates a 30-second print cycle at the

IP5.

• Any print command initiated from the MR200 takes precedence over the IP5 print functions.

PRINTER Menu

ThePRINTERSETUPoption(intheSETUPmenu)opensthePRINTERmenu,whichcontains

optionsforprintersetupandcontrolwhentheMR200isequippedwithanoptionalIP5and

printer.Forexpandedprintingoptionsnotcoveredinthismanual,consulttheIP5IFU.

10‐10TrendDataandPrinting ExpressionMR200InstructionsforUse

.

TochangesettingsinthePRINTERmenu

Setup key

Control knob

PRINTER

menu

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2

TurnthecontrolknobtoPRINTERSETUPandthenpresstheknob.

ThePRINTERmenuappears.Currentsettingsaredisplayed.

3Turnthecontrolknobtoselectanyofthefollowingprinteroptions

andthenpresstheknob:

TRACE1

TRACE2

TRACEDELAY

Forinformation,seetheappropriatesectionsbelow.

4Turntheknobtothedesiredsettingandthenpresstheknob.

5Tochangeotheroptions,repeatsteps3and4.

6PresstheMainkeytoclosethemenu.

Alternative:TurntheknobtoRETURNandthenpresstheknob,or

waitapproximately60seconds.

ExpressionMR200InstructionsforUseTrendDataandPrinting10‐11

TRACE 1

Enablesthefirsttracetobeoutputbytheprinter.Thestripchartmaybeconfiguredtocontain

oneortwowaveforms(seeTRACE2,below).Adescriptionofeachitemprintedonthestripchart

isprovidedbelow.

Thefollowingchoicesareavailable:

•ECG1(TraceA)(Default)

•ECG2(TraceB)

•SPO2(TraceC)

•RESP(CO2)(TraceD)

ToprintaTrace1waveform

EnterthePRINTERmenu.PressthecontrolknobtoselectTRACE1andpresstheknob.Scrollto

thedesiredoutputandpresstheknob.

Definition

1 Trace 1 parameter

2 Date and time (formatted as MM/DD/YY-HH:MM:SS)

3 Patient type

4Trace delay

5 Trace speed

6 Parameter information

7 Values of active parameters at time of printing

8 Trace 2 parameter information

9 Trace 2 parameter

10 Trace 2 waveform

11 Trace 1 waveform

1234567

8

9

11

10

10‐12TrendDataandPrinting ExpressionMR200InstructionsforUse

TRACE 2

Enablesthesecondtracetobeoutputbytheprinter.

Thefollowingchoicesareavailable:

•OFF(Default)

•ECG1outputstheTraceAwaveform.(Default)

•ECG2outputstheTraceBwaveform.

•SPO2outputstheTraceCwaveform.

•RESP(CO2)outputstheTraceDwaveform.

ToprintaTrace2waveform

EnterthePRINTERmenu.TurnthecontrolknobtoTRACE2andpresstheknob.Scrolltothe

desiredoutputandpresstheknob.

NOTE

If TRACE 2 is Off, a single trace is printed using the full 40 mm width of the strip chart. When

printing two traces, the waveform to grid ratio will not correspond to the waveform/scale

indicator size displayed on the LCD.

TRACE DELAY

Setsadelayperiodfortheprintedtrace.

Thefollowingchoices(inseconds)areavailable:

•0(Default)

•4

•8

•16

Tosetaprintingtimedelay

EnterthePRINTERmenu.TurnthecontrolknobtoTIMEDELAYandpresstheknob.Scrolltothe

desiredsettingandpresstheknob.

ExpressionMR200InstructionsforUseCleaningandMaintenance11‐1

CHAPTER 11

Cleaning and Maintenance

Environmental Requirements

RoyalPhilipsHealthcareisconcernedaboutprotectingthenaturalenvironmentandtohelp

ensurecontinuedsafeandeffectiveuseofthisproductthroughpropersupport,maintenance

andtraining.RoyalPhilipsequipmentisthereforedesignedandmanufacturedtocomplywith

relevantguidelinesforenvironmentalprotection.Aslongastheequipmentisproperlyoperated

andmaintained,itpresentsnorisktotheenvironment.However,theequipmentmaycontain

materialswhichcouldbeharmfultotheenvironmentifdisposedofincorrectly.Useofsuch

materialsisessentialfortheimplementationofcertainfunctionsandformeetingcertain

statutoryandotherrequirements.

ThissectionoftheInstructionsforUseisdirectedmainlyattheuseroftheequipmentorsystem,

thebodywithlegalauthorityovertheequipment.Operatorsarenotusuallyinvolvedindisposal,

exceptinthecaseofcertainbatteries,seepage11‐7.

General Cleaning Guidelines

KeeptheMR200andaccessoriesfreeofdust,dirtandpathogens.Aftercleaninganddisinfection,

alwayschecktheequipmentcarefully.Stopusingequipmentthatshowssignsofdeteriorationor

damage.Observethefollowinggeneralprecautionswhencleaning:

•Alwaysdilutethecleaningsubstanceaccordingtothemanufacturer’sinstructionsoruse

lowestpossibleconcentration.

• Neverallowliquidtoentertheequipment.

• Neverimmerseanypartoftheequipmentinliquid.

• Neverpourliquidontotheequipment.

• Neveruseabrasivematerialtowipetheequipment.

NOTE

For answers to questions regarding infection control:

• Users inside USA, call us at (877) 468-4861

• Users outside USA, call us at +31 (0) 499 378299

11‐2CleaningandMaintenanceExpressionMR200InstructionsforUse

Cleanusingalint‐freecloth,moistenedwithwarmwater(40°C/104°Fmaximum)andmildsoap,

adilutednon‐causticdetergentoralcohol‐basedcleaningagent.Neverusestrongsolventssuch

asacetoneortrichloroethylene.Stainscanberemovedbyscrubbingbrisklywithamoistened

cloth.Ifdisinfectionisrequired,cleantheequipmentbeforedisinfectingit.

UseonlytheRoyalPhilips‐approvedsubstancesandmethodslistedinthischaptertocleanor

disinfecttheequipment.RoyalPhilipsmakesnoclaimsregardingtheefficacyofthelisted

chemicalsormethodsasameansforcontrollinginfection.Warrantydoesnotcoverdamage

causedbyusingunapprovedsubstancesormethods.

Therecommendedtypesofdisinfectingagentsarelistedinthetablebelow.Wemakenoclaims

regardingtheefficacyofthelistedchemicalsormethodsasameansforcontrollinginfection.

Consultyourfacility'sInfectionControlOfficerorEpidemiologist.Forcomprehensivedetailson

cleaningagentsandtheirefficacyreferto“GuidelinesforPreventionofTransmissionofHuman

ImmunodeficiencyVirusandHepatitisBVirustoHealthCareandPublic‐SafetyWorkers”issued

bytheU.S.DepartmentofHealthandHumanServices,PublicHealthService,CentersforDisease

Control,February1989.Alsorefertoanypoliciesthatapplywithinyourfacilityandcountry.

*Followmanufacturer'sinstructionsformixing;werecommendasolutionof5,000ppm.

**Anyproductresidueshouldberemovedbywiping.

Cleaning the Cart and Modules

WARNING

Always disconnect the MR200 from AC power, and remove the batteries from the cart and

the wireless modules, before performing any cleaning or maintenance. To avoid an electrical

hazard, never immerse any part of the MR200 in any cleaning agent or attempt to clean it

with liquid cleaning agents.

FollowthegeneralguidelinestocleanthecartandthewECGandwSPO2modules.Alwaysturn

offthecartandthemodulestoperformcleaning.Neverimmerseportionofthecartorthe

modulesinfluidorattempttocleanthedevicesbydirectlyapplyingliquidcleaningagents.

Product Name Product Type

Actichlor™ Plus Tablet*

CaviWipes® Disinfectant Towelette

Coverage® Spray TB, TB Plus, HB Plus** Spray

Sklar Disinfectant** Towelette

Sani-Cloth Plus Wipes** Towelette

ExpressionMR200InstructionsforUseCleaningandMaintenance11‐3

CAUTIONS

• Other than those specified in the preceding table, avoid ammonia-, phenol- and acetone-

based cleaners as they will damage the surfaces of the MR200.

• Disinfect the cart and modules as determined by your hospital’s policy to avoid long term

damage to the product.

• Do not permit liquid to contact the front or rear of the display panel. Do not permit liquid to

drip into or around the LCD. Contact technical support if liquid enters any component.

• If the MR200 becomes accidentally wet during use, discontinue operation until all affected

components have been cleaned and permitted to completely dry. Contact technical support if

additional information is required.

Tocleananddisinfectthecartandwirelessmodules

Step Action

1TurnoffthecartandunplugtheACpowercord.Removethe

batteries,ifinstalled.

2 Removethebatteryfromeachwirelessmodule.

3 Removeallvisibledebrisfromthecartandwirelessmodulesusing

soapandwater.

CAUTIONS

Never pour liquid onto the equipment.

4Cleanthecartandmodulesbythoroughlywipingthedevicesusing

CaviWipesDisinfectanttowelettes.Discardtheusedtowelettes

(refertoyourfacility'sbiohazardprocedurefordisposal).

NOTE

Follow the instructions for use from the disinfectant manufacturer to

clean the cart and modules.

5 Disinfectthecartandmodulesbythoroughlywettingthedevices

usingCaviWipesDisinfectanttowelettes.Discardtheused

towelettes(refertoyourfacility'sbiohazardprocedurefor

disposal).

NOTE

Follow the instructions for use from the disinfectant manufacturer to

disinfect the cart and modules.

11‐4CleaningandMaintenanceExpressionMR200InstructionsforUse

Sterilizing the Cart and Wireless Modules

Thecartandthemodulesarenotsterilizable;donotimmerseanypartofthesedevicesinfluidor

attempttocleanthemwithliquidcleaningagents.Severedamage,notcoveredbythewarranty,

willresult.

Cleaning the Accessories

Anyreusablepatientaccessory(suchasSPO2attachmentsandsensors,ECGcables,NiBPcuffs,

chestbellows,etc.)mustbecleanedanddisinfectedbeforeinitialuse,andthenaftereachuse,to

protectpatientsandpersonnelfromavarietyofpathogens.Usesoapandwater,andasuggested

disinfectantandmethod,tocleananddisinfecttheaccessories.Thewarrantydoesnotcover

damagecausedbyunapprovedsubstancesormethods.

Disposableaccessoriesmustbediscardedandreplacedwithnewitems.

WARNING

Single-use devices, as indicated on the device packaging, should be disposed of

after use and must never be reused.Reuse of single-use devices can result in

spread of patient infection, degradation of monitoring performance, or

inaccurate measurements.

CAUTIONS

• Never immerse an accessory in any cleaning fluid.

• Do not autoclave any part of the equipment. Disinfect the accessory as determined by your

facility’s policy.

NOTE

Disposable SPO2 attachments: After some use, adhesive residue may accumulate at the fiber heads

on the sensor cable. Remove carefully any residue with some alcohol. The glass fiber ends must

always be clear and free from residuals.

6Allowthecartandthemodulestodry.(Norinsingisrequired.)

7Checkthecartandthemodulesforanyresidualdebris.Ifanydebris

ispresent,repeatsteps3through6thenre‐examinethecartand

modulesbeforeproceeding.

8Checkthecartandmodulesfordamageandcontacttechnical

supportifdamageisfound.

Step Action

ExpressionMR200InstructionsforUseCleaningandMaintenance11‐5

Tocleanareusableaccessory

Sterilizing the Accessories

Theaccessoriesarenotsterilizable.Severedamage,notcoveredbythewarranty,willresult.

Step Action

1 Removetheaccessoryfromuse.

2 Removeallvisibledebrisfromtheaccessoryusingsoapandwater.

CAUTION

Never pour liquid onto the accessory.

3CleantheaccessorybythoroughlywipingitusingCaviWipes

Disinfectanttowelettes.Discardtheusedtowelettes(refertoyour

facility'sbiohazardprocedurefordisposal).

NOTE

Follow the instructions for use from the disinfectant manufacturer to

clean the sensor.

4 DisinfecttheaccessorybythoroughlywettingitusingCaviWipes

Disinfectanttowelettes.Discardtheusedtowelettes(refertoyour

facility'sbiohazardprocedurefordisposal).

NOTE

Follow the instructions for use from the disinfectant manufacturer to

disinfect the sensor.

5Allowtheaccessorytodry.(Norinsingisrequired.)

6Checktheaccessoryforanyresidualdebris.Ifanydebrisispresent,

repeatsteps2through5thenre‐examinethesensorbefore

proceeding.

7Checktheaccessoryfordamageanddiscardtheaccessoryif

damageisfound;seepage11‐6fordetails.

8Storetheaccessory;seepage11‐6fordetails.

9Inspecttheaccessoryforanycracks,holes,tears,cuts,etc.that

couldaffectoperationandreplaceasnecessary.

11‐6CleaningandMaintenanceExpressionMR200InstructionsforUse

Inspecting the Accessories for Damage

Theaccessoriesareexposedtopotentiallydamagingsituationsduringuseandcleaning.Before

eachuse,carefullyinspecttheaccessoriesforthefollowingsignsofdamage:

•Cracks,holes,tears,gouges,cuts,etc.

•Cracksorothersignsofdamagetotheconnector,includingbentordamagedpins.

WARNING

Cracks, tears, cuts and gouges interfere with standard cleaning procedures and therefore

pose a potential risk to patients and personnel. If you see any sign of damage to any

accessory, immediately discontinue use.

Storing the Accessories

Thecarthasbuilt‐instoragefeaturestohousewirelessmodulesandaccessoriesusedduring

monitoring;seepage2‐3.

WARNING

To reduce the spread of infection, do not store accessories directly on the MR200 handles.

CAUTION

When inserting or removing the accessories from the cart or wireless modules, only use the

connector and never pull or apply excessive force or tension to any other portion of the device.

Tostorethewirelessmodulesandsensorsandcables

Whennotinuse,slidethewECGandwSPO2modulesintothemoduleholdersonthecart.

Tostoretheotheraccessories

Whennotinuse,loopsamplelinesandthenplacetheminthestoragebasketordrapethem

overanoptionalaccessoryhook.

Final Disposal

Finaldisposaliswhentheuserdisposesoftheequipment(system,accessoriesandbatteries)in

suchawaythatitcannolongerbeusedforitsintendedpurposes.

ExpressionMR200InstructionsforUseCleaningandMaintenance11‐7

WARNING

Do not dispose of this product (or any parts of it) in industrial or domestic waste.

The system may contain materials and hazardous substances that can cause

serious environmental pollution. The system also contains privacy sensitive

information. It is advisable to contact your Royal Philips Service Organization

before disposing of this product.

RoyalPhilipsHealthcaregivessupportfor:

• Recoveryofreusableparts.

•Therecyclingofusefulmaterialsbycompetentdisposalcompanies.

•Safeandeffectivedisposalofequipment.

Fordetaileddisposalinformation,gotothefollowingwebpage:

http://www.healthcare.philips.com/main/about/sustainability/recycling/pm.wpd

Therecyclingpassportslocatedtherecontaininformationonthematerialcontentofthe

equipment,includingpotentiallydangerousmaterialswhichmustberemovedbeforerecycling

(forexample,batteries).

Disposal of the Device and Accessories

TheMR200andaccessoriesaresubjecttostrictdisposalregulationsforuserandenvironmental

safety.Neverdisposeofwasteelectricalandelectronicequipmentasunsortedmunicipalwaste.

Collectitseparatelysothatitcanbesafelyandproperlyreused,treated,recycledorrecovered.

WARNING

To avoid contaminating or infecting personnel, the environment or other equipment, make

sure you disinfect and decontaminate the MR200 appropriately before disposing of it in

accordance with your country's laws for equipment containing electrical and electronic

parts. Do not dispose of this product (or any parts of it) in industrial or domestic waste. The

system may contain materials such as lead, tungsten or oil, or other hazardous substances

that can cause serious environmental pollution. The system also contains privacy sensitive

information. It is advisable to contact your Royal Philips Service Organization before

disposing of this product. You can disassemble the MR200 and accessories as described in

the service manual.

Disposing of Batteries

Thelithiumbatteriesfoundinthesystemandsomeoftheaccessoriesoroptionalequipment

maybesubjecttostrictdisposalregulationsforuserandenvironmentalsafety.Observeand

adheretoyourcurrentlocalregulationswhendisposingofbatteries.

11‐8CleaningandMaintenanceExpressionMR200InstructionsforUse

CAUTIONS

• Never heat or throw a battery into fire. Heating the battery will damage the safety circuitry,

which can cause rupture or ignition of the battery.

• Never disassemble a battery. The batteries contain hazardous material that must be recycled

or disposed of properly. (Refer to the disposal guidelines below.)

Maintenance

PeriodicmaintenancefortheMR200,asoutlinedbelow,mustbefollowed.

CAUTION

Annual preventative maintenance is recommended unless stated otherwise in the service manual.

For proper equipment maintenance, perform the service procedures at the recommended intervals

as described in the service manual.

Testing CO2 Accuracy

TheCO2flowrateaccuracyshouldbeverifiedbydirectmeasurementusingacalibratedflow

meterevery12months.(SeeGASCALonpage11‐14.)

CAUTION

An internal leak may result in condensation within the system. If this is suspected or if

condensation is observed, discontinue use and contact technical support.

Testing the NiBP System

TheNiBPsystemshouldbetestedatleastonceevery12monthstoensureproperoperation.

WARNING

Never initiate the LEAK TEST while the cuff is applied to a patient. Continuous cuff

pressure can lead to patient injury.

ExpressionMR200InstructionsforUseCleaningandMaintenance11‐9

TotesttheNiBPsystemforleakage

Step Action

1 Attachanormaladultcuffandinterconnecthose,oratestvolume

totheMR200.

2

PressthePATIENTkey.

ThePATIENTmenuappears.

3TurnthecontrolknobtoADULT(orPEDIATRIC)andthenpressthe

knob.

4PresstheSETUPkey.

TheSETUPmenuappears.

5TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

6TurnthecontrolknobtoSERVICE(BIO‐MED)andpresstheknob.

TheSERVICE(BIO‐MED)menuappears.

7TurnthecontrolknobtoNiBPTESTSandpresstheknob.

TheNiBPTESTSmenuappears.

8TurnthecontrolknobtoLEAKTESTandthenpresstheknob.

TheNiBPLEAKTESTdialogboxappears.

9Turntheknobtothedesiredactionandthenpresstoproceed.

10 ResultsareprovidedontheLCDastheroutineprogressesthrough

thedifferenttests.

11‐10CleaningandMaintenanceExpressionMR200InstructionsforUse

Default Initialization

ThesettingsfortheMR200canberestoredtofactorydefaultvalues.

Updating Software

Asrevisionstothesoftwarebecomeavailable,theMR200canbeupdated.Itisrecommended

thatyousaveyoursettingspriortoupdatingsoftware,sothattheycanberestoredafterward;

seeSTORESETUPSonpage3‐5.

WARNING

When performing software updates (or upgrades) to the operating software of the MR200,

ensure that all remaining devices in the monitor’s network are at the same or a compatible

software revision level. Failure to observe this requirement could result in compatibility

conflicts, communication problems, etc.

Toupdatetheoperatingsoftware

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

3TurnthecontrolknobtoDEFAULTSETUPSandpresstheknob.

4ScrolltoFACTORYandpresstheknob.

Allcurrentsettingswillbelost.

5TurnofftheMR200.

6TurnontheMR200.

Themonitor’ssettingsarereturnedtothefactorydefaultvalues.

Step Action

1ConnectACpowertothecartandinsertatleastonefullycharged

battery.

2Turnonthecartthenwaituntilthenormalmodeisdisplayed;see

LCDonpage2‐13.

ExpressionMR200InstructionsforUseCleaningandMaintenance11‐11

3InserttheUSBprogramupdatedevicethatcontainsthedesired

softwareintotheUSBport.

4TheWPUProgramUpdatewindowappears.

Currentsoftwarerevisionsaredisplayed,whereanyneededupdate

willbedenotedbyanasterisk.

5TurnthecontrolknobtoYESandthenpresstheknobtoproceed.

Thesoftwareupdatebegins.Aprogressbarisdisplayedandwhen

allapplicableprogramupdateshavefinished,theWPUProgram

Updatewindowchangestoindicatecompletion.

6TurnoffthecartandremovetheUSBprogramupdatedevicefrom

theUSBport.

7Pressandholdthecontrolknobwhileturningonpowertothecart.

8ObservetheLCD.Whenthecursormovestotheupperleftcorner

ofthescreen(approximately10–15secondsafterpower‐up),

releasethecontrolknobthenimmediatelypressandholdtheMain

key.

9Whenthecoldstartbannerismomentarilydisplayed,releasethe

Mainkey

.

TheMR200willboottothenormalmode.

10 Ifthecoldstartbannerwasnotdisplayed,repeatsteps7–9.

Step Action

USB port

USB program

update device

11‐12CleaningandMaintenanceExpressionMR200InstructionsforUse

SERVICE(BIO-MED) Menu

TheSERVICE(BIO‐MED)menucontainssoftwareandfirmware

informationaboutthesystemandoptionsforpressure,diagnostics

andconfiguration.

NOTE

Some SERVICE(BIO-MED) menu options require entry of a password for access. For password

assistance, contact technical support. For details regarding these password-protected options,

reference the service manual.

11 PresstheSetupkey.

TheSETUPmenuappears.

12 TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

13 TurnthecontrolknobtoSERVICE(BIO‐MED)andthenpressthe

knob.

TheSERVICE(BIO‐MED)menuappears.Currentsettingsare

displayed.

14 WithS/WREVhighlighted,pressthecontrolknob.Verifythatthe

displayedREVISIONINFORMATIONincludestheversionnumberfor

thesoftwarethatwasupdated.

Step Action

ExpressionMR200InstructionsforUseCleaningandMaintenance11‐13

ToentertheSERVICE(BIO‐MED)menu

S/W REV

Opensawindowthatcontainsrevisionlevelandbuilddate

informationforthesoftwarecomponents.(Toclosethewindow,

pressthecontrolknoborwait60seconds.)

SIMULATION MODE

Step Action

1PresstheSETUPkey.

TheSETUPmenuappears.

2TurnthecontrolknobtoMONITORSETUPandthenpresstheknob.

TheMONITORmenuappears.Currentsettingsaredisplayed.

3TurnthecontrolknobtoSERVICE(BIO‐MED)andthenpressthe

knob.

TheSERVICE(BIO‐MED)menuappears.Currentsettingsare

displayed.

4Turnthecontrolknobtoselectanyofthefollowingoptionsand

thenpresstheknob:

S/WREV

SIMULATIONMODE

NiBPTESTS

GASCAL

SERVICEUTILITIES

SYSTEMCONFIG

Forinformationabouttheseoptions,seetheappropriatesections

below.

5PresstheMainkeytoclosethemenu.

Alternative:TurntheknobtoRETURNandthenpresstheknob.

11‐14CleaningandMaintenanceExpressionMR200InstructionsforUse

PlacestheMR200intosimulationmode.

Toentersimulationmode

Pressthecontrolknob.Adialogboxwillpromptyoufor

confirmation.Usethecontrolknobtohighlightthedesiredaction

andthenpresstheknobtoproceed.

Whileinsimulationmode,toinitiatesimulatedNiBPfunctions,presstheNiBPkey.

Toexitsimulationmode

Turnoffthepowerswitch.

WARNING

The MR200 is equipped with a simulation mode that displays computer generated data for

training or demonstration. As a safety feature, SIMULATION is displayed and appears on

all printouts while in simulation mode. Do not attach a patient to the MR200 when in

simulation mode and never activate simulation mode when a patient is connected. The

MR200 will not monitor patients while in the simulation mode. Activating simulation mode

when a patient is connected will result in a lapse in patient monitoring and could result in a

delay in treatment.

NiBP TESTS

AccessesNiBPcalibrationandtestingfunctions.

•CALIBRATEperformscalibrationoftheNiBPsystem.(Passwordrequired)

•LEAKTESTteststheNiBPsystemforpressureleaks.

Toperformtheleaktest

Seepage11‐8.

•STATICTESTteststhepressureoftheNiBPsystem.(Passwordrequired)

GAS CAL

AccessestheCO2calibrationandtestingfunctions.

NOTE

Wait 2 minutes for CO2 warm-up before calibrating or performing an accuracy check.

Thefollowingchoicesareavailable:

ExpressionMR200InstructionsforUseCleaningandMaintenance11‐15

•ZEROCALperformsazerocalibrationoftheCO2system.(Alsoseepage7‐11.)

Tostartzerocalibration

EntertheSERVICE(BIO‐MED)menu.TurnthecontrolknobtoGASCALandpresstheknob.

ScrolltoZEROCALandpresstheknob.

•CO2ACCURACYCHECKteststheCO2

function(a5%sourcemustbeconnected).

ProvidesaCO2waveformvalue(asa

percentage),anatmosphericpressure

readingandanumericCO2value(in

mmHg).

Toperformanaccuracycheck

Connectthe5%CO2sourcetotheCO2port.EntertheSERVICE(BIO‐MED)menuandscroll

toGASCAL.PressthecontrolknobthenscrolltoCO2ACCURACYCHECKandpressthe

knobagain.(Awarningdialogwillappear:CO2BENCHSHOULDBEWARMEDUPPRIORTO

STARTINGACCURACYTEST.Pressthecontrolknobwhenreadytoproceed.)

NOTE

During the accuracy check, to alert you that the indicated values are not actual patient numerics,

the following dialog box message will be displayed: CO2 test in progress. Do not use CO2 values

for patient monitoring during test. Pressing close will cancel test.

SERVICE UTILITIES

Accessesservice‐relatedfunctions(passwordrequired);seetheservicemanualfordetails.

SYSTEM CONFIG

ConfigurestheparametersandoptionsoftheMR200.(Forpasswordprotectedfunctions,see

theservicemanualfordetails.)

11‐16CleaningandMaintenanceExpressionMR200InstructionsforUse

•LANGUAGEsetsthelanguagedisplayedbytheMR200(tomaketheselectioneffective,

cyclepoweraftersavingyourchanges):

–ENGLISH(Default)

–DEUTSCH

–ESPANOL

–FRANCAIS

–PORTUGUES(Br)

–ITALIANO

–DANSK

–SVENSKA

–NORSK

–NLD

•PRESSUREUNITSsetstheunitofmeasureforNiBPreadings:

–mmHgprovidesreadingsinmillimetersofmercury.(Default)

–kPaprovidesreadingsinkilopascals

Repair

TheMR200containsnouser‐serviceableparts.Allrepairsmustbeperformedbytrainedservice

personnel.Allrepairsonproductsunderwarrantymustbeperformedbyauthorizedpersonnel

orinanauthorizedServiceandRepairCenter.Unauthorizedrepairswillvoidthewarranty.

WARNING

A shock hazard exists if the MR200 is operated without covers.

ExpressionMR200InstructionsforUseCleaningandMaintenance11‐17

IftheMR200failstofunctionproperlyorrequiresmaintenance,contacttechnicalsupport:

1‐877‐INVIVO1

or

1‐877‐468‐4861

Internationally,pleasecontactyourKeyMarketrepresentative.Foracurrentlisting,goto

www.invivocorp.com

CAUTIONS

• This product, or any of its parts, must not be repaired other than in accordance with written

instructions provided by Invivo (Royal Philips), or altered without prior written approval.

• No repair should ever be undertaken or attempted by anyone not having a thorough

knowledge of the repair of Invivo (Royal Philips) patient monitoring systems. Only replace

damaged parts with components manufactured or sold by Invivo (Royal Philips). Contact

the Technical Service and Repair Center for assistance and service.

CAUTION

The user of this product shall have the sole responsibility for any malfunction which results from

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

Invivo (Royal Philips) or its authorized service personnel.

Passing This Product on to Another User

Ifthisproductistobepassedontoanotheruserwhoistouseitforitsintendedpurpose,thenit

shouldbepassedoninitscompletestate.Inparticular,theexistingusershouldmakesurethatall

theproductsupportdocumentation—includingallInstructionsforUse—arepassedontothenew

user.AnewusershouldbemadeawareofthesupportservicesthatRoyalPhilipsHealthcare

providesforinstalling,commissioningandmaintainingtheequipmentorsystem,andforthe

comprehensivetrainingofoperators.Existingusersmustbearinmindthatpassingonmedical

electricalequipmenttonewusersmaypresentserioustechnical,medical,privacyandlegalrisks.

Theoriginalusermayremainliableeveniftheequipmentisgivenaway.

ExistingusersarestronglyadvisedtoseekadvicefromtheirlocalRoyalPhilipsHealthcare

representativebeforeagreeingtopassonanyequipment.

Oncetheequipmenthasbeenpassedontoanewuser,theprevioususermaystillreceive

importantsafety‐relatedinformation,suchasservicebulletinsandfieldchangeorders.Inmany

jurisdictions,thereisacleardutyontheprevioususertocommunicatesuchsafety‐related

informationtonewusers.

11‐18CleaningandMaintenanceExpressionMR200InstructionsforUse

PrevioususerswhoarenotableorpreparedtodothisshouldinformRoyalPhilipsHealthcare

aboutthenewuser,sothatRoyalPhilipsHealthcarecanprovidethenewuserwithsafety‐related

information.

Packaging the MR200

TopackagetheMR200forshipment,usetheMR200packingmaterialstosafelytransportthe

monitor.

CAUTION

If shipment of the MR200 is required, batteries must be removed prior to transport.

TopacktheMR200

Step Action

1InalocationoutsideoftheMRmagnetroom,ensurethatpoweris

disconnectedandthatbothbatteriesareremovedfromthecart.

2CovertheLCD.InstallfoamAovertheupperportionofthecart.

ExpressionMR200InstructionsforUseCleaningandMaintenance11‐19

3Withthecrateorientedasshown,placeitintoanuprightposition.

Rollthecartintothecrate.

4 Carefullylowerthecrate.SlidefoamBintofoamCtheninsertit

betweenthebaseofthecartandthecrate.

5Insert

foamDintofoamA,andinsertfoamEbetweenfoamCand

thecrate.

Step Action

11‐20CleaningandMaintenanceExpressionMR200InstructionsforUse

6Placethelidonthecrate.

7Installalltheclipsintothelidonthecrate,ensuringthateachis

locked.

Step Action

ExpressionMR200InstructionsforUseSpecificationsA‐1

APPENDIX A

Specifications

General

Patient Safety

ConformstoANSI/AAMIES60601‐1.CertifiedtoCAN/CSAC22.2No.60601‐1.

Conformsto93/42/EECasamendedby2007/47/EEC

Defibrillatorprotectionupto5KV

Accordingtodegreeofprotectionagainstharmfulingressofwater:ordinaryequipment,IPX0(enclosedequipment

withoutprotectionagainstingressoffluids)

Whereappropriate,theequipmentcompliestoworldwidestandardsforsafetyandperformanceofeachsystem

feature,whenconsideringtheindicationsforusewithintheMRenvironment.Thisequipmentcompliestothe

followinginternationalindustrystandardsforsafetyandperformance:

•IEC60601‐1,GeneralRequirementsforSafetyofMedicalElectricalEquipment

•IEC60601‐1‐2,GeneralRequirementsforSafety‐ElectromagneticCompatibility

•IEC60601‐1‐6,GeneralRequirementsforSafety‐CollateralStandard:Usability

•IEC60601‐1‐8,GeneralRequirements,TestsandGuidanceforAlarmSystemsinMedicalElectricalEquipment

andMedicalElectricalSystems

•IEC60601‐2‐27,ParticularRequirementsforSafety‐SpecificationforElectrocardiographicMonitoring

Equipment

•IEC60601‐2‐49,ParticularRequirementsforSafety‐SpecificationforMultifunctionPatientMonitoring

Equipment

•IEC80601‐2‐30,MedicalElectricalEquipment‐Part2‐30:ParticularRequirementsfortheSafety,Including

EssentialPerformance,ofAutomaticCyclingNon‐InvasiveBloodPressureMonitoringEquipment

•ISO80601‐2‐61,MedicalElectricalEquipmentParticularRequirementsfortheBasicSafetyandEssential

PerformanceofPulseOximeterEquipmentforMedicalUse

•ISO80601‐2‐55,MedicalElectricalEquipmentParticularRequirementsfortheBasicSafetyandEssential

PerformanceofRespiratoryGasMonitors

•ISO10993‐1,BiologicalEvaluationofMedicalDevices‐Part1:EvaluationandTesting

•ISO10993‐5,BiologicalEvaluationofMedicalDevices‐Part5:TestsforCytotoxicity:Invitromethods

•ISO10993‐10,BiologicalEvaluationofMedicalDevices‐Part10:TestsforIrritationandDelayed‐Type

Hypersensitivity

A‐2SpecificationsExpressionMR200InstructionsforUse

Additionally,thisequipmentcompliestothefollowingnationalorregionalindustrystandardsforsafetyand

performance:

• 1999/5/EC,Radio&TelecommunicationsTermi nalEquipmentDirective

•SAAAS/NZS3200.1.2,GeneralRequirementsforSafety‐ElectromagneticCompatibility

•ANSI/AAMIEC13:2002/(R)2007,CardiacMonitors,HeartRateMeters,andAlarms

•ANSI/AAMISP10:2008,Manual,Electronic,orAutomatedSphygmomanometers

• 2006/66/EC,BatteryDirective

•UL2054:2004Secondarycellsandbatteriescontainingalkalineorothernon‐acidelectrolytes,Standardfor

HouseholdandCommercialBatteries

•IEC62133:2002,Secondarycellsandbatteriescontainingalkalineorothernon‐acidelectrolytes,Standardfor

HouseholdandCommercialBatteries

• 2002/96/EC,DirectiveonWasteofElectricalandElectronicEquipment

•ASTMF2503‐08,StandardPracticeforMarkingMedicalDevicesandotherItemsforSafetyintheMR

Environment

•ASTMF2052‐06,StandardTestMethodforMeasurementofMagneticallyInducedDisplacementForceon

MedicalDeviceinMREnvironment

Power Requirements, Cart

OperatingVoltageRange 100VACto240VAC

FrequencyRange 47Hzto63Hz

Current 1.5A@115VAC/0.7A@240VAC

PowerConsumption,Maximum 65Watts

Battery

TypeCart:Lithium‐Ion

Module:Lithiumpolymer

OperationTimeCart:Maximumoperationtimeisapproximately8hourswhenECG

andSPO2areon,CO2isoff,andNiBPisrunningat5‐minute

intervals(timemaybereducedbyupto2hoursundercertain

conditions,suchasrunningshorterNiBPcycles).Withthecartoff,

insertedandfullychargedbatterieswillnotcompletelydischarge

foratleast72hours.

Module:Approximateoperationtimeofthebatteryis8hours.

ChargeTime Cart:Torechargeafullydischargedbatteryisapproximately12

hourswiththeMR200turnedoff.

Module:Torechargeafullydischargedbatteryisapproximately3

hours.

MinimumVoltage

(Fornormaloperation)

Cart:14.8V

Module:3.4V

ExpressionMR200InstructionsforUseSpecificationsA‐3

Environment

OperatingTemperatureRange 10°Cto35°C(50°Fto95°F)

Storage/TransportTemperatureRange Batteries:0°Cto40°C(32°Fto104°F)

Cart:‐20°Cto50°C(‐4°Fto122°F)

Wirelessmodules:‐25°Cto75°C(‐13°Fto167°F)

Accessories:‐20°Cto60°C(‐4°Fto140°F)

(Whenstoringortransportingintemperaturesbeyondtheranges

specifiedabove,removethedesignatedcomponentandstoreor

moveitappropriately.)

RelativeHumidityRange 15%to80%,non‐condensing

OperatingAltitudeRange Fromsealevelupto10,000feet(3048m)(708mbar)

Storage/TransportAltitudeRange From1020mbarto708mbar

Dimensions and Weights

(Allmeasurementsmadewithoutaccessories)

Height Cart:54.22inches(137.71cm)

WirelessECGmodule:4.7inches(11.9cm)

WirelessSPO2module:5.5inches(13.9cm)

Width Cart:22.15inches(56.26cm)

WirelessECGmodule:2.5inches(6.4cm)

WirelessSPO2module:2.5inches(6.4cm)

Depth Cart:25.25inches(64.14cm)

WirelessECGmodule:0.91inches(2.3cm)

WirelessSPO2module:0.91inches(2.3cm)

Weight Cart:74.06pounds(33.59kg)

WirelessECGmodule:5.4ounces(158.8g)

WirelessSPO2module:5.4ounces(158.8g)

Liquid Crystal Display

Type 800x600pixels,color

ScreenSize 12.1inches(30.7cm)diagonal

SweepSpeed ForECGandSPO2,aspeedof25mm/secondgives9.2secondsof

displaytime,while50mm/secondgives4.6seconds.

Forrespiration,aspeedof0.33,1.56,3.13,6.25,12.5or25mm/

secondisused.

WaveformDisplayMode Fixedtrace,movingerasebar

WaveformDisplayHeight ≥19mm

“FullScreen”DisplayHeight ≥75mm

Batteryindication Timeremaining,redlowwarning

Alarmindication Onehertzflashingfrequencywith50percentdutycycle,visibleat

4metersandlegibleat1meter(assumingavisualacuityof20/20

andwithnolineofsightobstructions).

A‐4SpecificationsExpressionMR200InstructionsforUse

Displayed Parameters

Time Battery‐backedquartzcrystalclock

Alarms Highandlowlimitsselectableforpatientparameters

ECG ECGwaveformscale,displayedleads(2)

HeartRate NormallyderivedfromECG.Maybemanuallyselectedtobe

derivedfrompulseoximetry,orautomaticallyinorderofpriority.

PulseOximeter Pulserate,pulsewaveformandpercentsaturation

Trends Heartrate,respirationrate,NiBP(systolic,mean,diastolic),CO2

andSPO2

CO2 Bothend‐tidalandinspiredCO2

NiBP Pressures(systolic,mean,diastolic)andstatus

RespirationRate RespirationratederivedfrombellowsorCO2

ECG

ECG Amplifier

Protectedagainstdefibrillatorandelectrosurgerypotentials

StandardLeadConfigurations I,II,III,AVR,AVL,AVF

LeadFail Passive,sensingsignalimbalance

ECGInputImpedance >2.5MΩ(accordingtoIEC60601‐2‐27,50.102.3)

Heart Rate

Range 30to249BPM(Adult)

30to300BPM(Neonate,Pediatric)

Accuracy IntheabsenceofanMRIgradientartifact:±1%or±1BPM,

whicheverisgreater.

InthepresenceofanMRIgradientartifact:±1%from30‐200

BPM,±1.5%from200‐250BPM,and(neonatalonly)±2.0%from

251‐300BPM

Resolution 1BPM

Cardiotach

Sensitivity(Monitorfilter) AdultECGmode:>200uV

Neonate/PediatricECGmode:>100uV

Bandwidth Monitor:0.5Hzto40Hz

TallT‐WaveRejectionCapabilityforHeartRate

Indication

2mVwitha1mVQRSamplitude

ExpressionMR200InstructionsforUseSpecificationsA‐5

Alarm Limits (HR)

Lower

Upper

Offor30to249

60to249oroff

Test/Calibrations

SquareWaveTestSignal 60BPM±1BPM,1mV±10%

ECG Supplemental Information, as required by IEC 60601-2-27

HeartRateAveragingMethod Meanfilteringisappliedtotheoutputofthemedianfilterofa

continuouslyupdatinggroupofQRScomplexes.TheECGheart

ratenumericisupdatedtwiceasecond.

TimetoAlarmforTachycardia

B1‐VentTachycardia

1mVpp,206BPM

B2‐VentTachycardia

2mVpp,195BPM

Gain0.5(12.03,11.04,14.1,11.8,11.4)Average:12.1sec(The

monitoringsystemmaytemporarilyexitthealarmcondition

duringthearrhythmiawaveformduration.)

Gain1.0(11.9,11.6,9.2,9.6,10.9)Average:10.6sec

Gain2.0(8.8,9.1,10.3,9.4,12.1)Average:9.9sec

Gain0.5(9.0,10.4,12.3,8.1,10.4)Average:10.0sec

Gain1.0(8.4,7.7,12.5,7.7,8.3)Average:8.9sec

Gain2.0(9.7,12.6,8.9,11.8,8.3)Average:10.3sec

NOTE

Measurements made in FILTER MODE - MONITOR, outside of the MR environment. The alarm condition response

time of some arrhythmia complexes may be affected by MRI gradient artifacts.

ResponseTimeofHeartRateMetertoChange

inHeartRate

HRchangefrom80BPMto120BPM:8.3secaverage

HRchangefrom80BPMto40BPM:7.9secaverage

HeartRateMeterAccuracyandResponseto

IrregularRhythm

A1:Ventricularbigeminy:40BPM

A2:Slowalternatingventricularbigeminy:30BPM

A3:Rapidalternatingventricularbigeminy:115–125BPM

A4:Bidirectionalsystoles58–85BPM

NOTE

Measurements made in FILTER MODE - MONITOR, outside of the MR environment. The accuracy of the indicated

heart rate may be affected by MRI gradient artifacts.

A‐6SpecificationsExpressionMR200InstructionsforUse

Pulse Oximeter

Pulsetonepitchismodulatedbythesaturationvalue

SaturationRange 0to100%

SaturationAccuracy ±3%at70%to100%

PulseMeasurementRange 30BPMto250BPM

PulseAccuracy ±2%or1BPM,whicheverisgreater

WavelengthRange 500nmto1000nm

EmittedLightEnergy <15mW

PulseOximeterCalibrationRange 70%to100%

Alarm Limits

Lower

Upper

Offor50to99

70to99oroff

When“HR”isderivedfromSPO2

Lower

Upper

Offor30to249

60to249oroff

NOTE

Measurement validation: SPO2 accuracy validated in human studies against arterial blood sample reference measured

with a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with saturation levels between 70–100

percent SPO2 were studied. The population characteristics for those studies were:

• about 50% female and 50% male subjects

• 19–27 years of age

• light to black skin tones

A functional tester cannot be used for accuracy assessment of a pulse oximeter monitor; however, it can demonstrate

that a pulse oximeter monitor reproduces a calibration curve that has been independently demonstrated to fulfill a

particular accuracy specification.

SPO2 measurements are statistically distributed; therefore, in accordance to ISO 9919:2005, it is possible that only

two-thirds of the measurements will fall within ± 3 percent of the value measured by the CO-Oximeter.

ExpressionMR200InstructionsforUseSpecificationsA‐7

Non-Invasive Blood Pressure

General Oscillometrictechnology(withaninflatablecuff)determines

systolic,diastolicandmeanarterialpressures

PatientTypes Adult,PediatricandNeonate

Pneumatic Systems

CuffInflationPressure Initial:165mmHgforAdult,130mmHgforPediatric,and100

mmHgforNeonate(allpressuresare±15mmHg)

SubsequentinflationpressuresdeterminedbylastNiBP

measurement

OverpressureProtection Automaticreleaseofcuffpressureifinflationpressureexceeds300

mmHgforAdultandPediatricmodes,and150mmHgforNeonate

mode

UnitofMeasure mmHgorkPa

Measurement Range

Systolic

Adult

Pediatric

Neonate

30mmHgto270mmHg

30mmHgto180mmHg

30mmHgto130mmHg

Mean

Adult

Pediatric

Neonate

20mmHgto255mmHg

20mmHgto160mmHg

20mmHgto120mmHg

Diastolic

Adult

Pediatric

Neonate

10mmHgto245mmHg

10mmHgto150mmHg

10mmHgto100mmHg

Accuracy

PressureMeasurementAccuracy Maximummeanerror±5mmHgwithastandarddeviationofless

than8mmHg

PressureMeasurementResolution 1mmHg

PressureTransducerRange 0to300mmHg

A‐8SpecificationsExpressionMR200InstructionsforUse

Alarm Limits

Systolic

Adult&Pediatric

Lower

Upper

Neonate

Lower

Upper

Mean

Adult&Pediatric

Lower

Upper

Neonate

Lower

Upper

Diastolic

Adult&Pediatric

Lower

Upper

Neonate

Lower

Upper

Offor46to254

46to254oroff

Offor46to124

46to124oroff

Offor26to239

26to239oroff

Offor26to94

26to94oroff

Offor16to224

16to224oroff

Offor16to84

16to84oroff

Modes

Manual Immediateuponoperatorcommand

Automatic Determinationsautomaticallymadewithselectableintervalsof1,

2,2.5,3,5,10,15,20,30and45minutes;and,1,2and4hours

ExpressionMR200InstructionsforUseSpecificationsA‐9

CO2 (Optional)

Sidestream,non‐dispersiveinfraredabsorptiontechnique.Includingmultiplefiltrationsystemandmicroprocessor

logiccontrolofsamplehandlingandcalibration.

Output CO2waveform,EtCO2andFiCO2numericvalues,andrespiration

rate

CO2UnitofMeasure mmHgorkPa

InitializationTime Waveformdisplayedinlessthan20seconds,atanambient

temperatureof25°C;fullspecificationsattainedwithin2minutes

InspiredCO2Measurement Range:3mmHgto50mmHg

Method:LowestreadingoftheCO2waveformintheprevious20

seconds

CO2Accuracy

(Allmeasurementsatgastempof25°C)

±4mmHgor±12%,whicheverisgreater,afterthespecified

warm‐upperiod

CO2MeasurementRange

(InwhichtheCO2accuracyspecificationismet)

0to76mmHgforrespirationratesrangingfrom4to60breaths

perminute,inclusive

CO2Resolution 1mmHg

CO2Stability ShortTermDrift:Driftnottoexceed0.8mmHgover4hours

LongTermDrift:Accuracyspecificationmaintainedovera120‐

hourperiod

ZeroCalibrationInterval Automaticoruserrequested

FlowRate 50mL/minute±10mL/minute

RespirationAccuracy±1breathor±3%whicheverisgreater

RespirationRateRange

(Inwhichtherespirationaccuracyspecification

ismet)

4to100breathsperminute,inclusive

RespirationResolution 1breathperminute

Response(Rise)Time

Adult&Pediatric

Neonate

(Asmeasuredfromthepatientgasinputofthe

completepneumaticcircuit[includingtubing],

from10%to90%ofthemeasuredCO2levels)

800ms

440ms

Compensations

(AutomaticCO2ambientpressure

compensation400to800mmHg)

CompensationsforexpiredO2Balancegas(N2,N2O,O,He)and

AnestheticAgentsB

Usesgascompensationinformationtocorrecttherawcarbon

dioxidevalue

A‐10SpecificationsExpressionMR200InstructionsforUse

A.

(FromOlivierC.Wenker:ReviewofCurrentlyUsedInhalationAnesthetics:PartI.TheInternetJournalofAnesthesiology,1999,Volume

3Number.)

B.

AnestheticAgentEffects

(MACLevels)

AnestheticAgentSensitivityA(uncompensated):Accuracy

specificationwillbemaintainedforhalogenatedanestheticagents

presentatacceptedMAC(MinimumAlveolarConcentration)

clinicallevels.

AnestheticAgentSensitivity(compensated):Testingatagent

levelsdefinedbyacceptedregulatorystandards(i.e.,ISO21647,

ASTMF1456,IEC/CDV60601‐2‐55)currentlyinprocess.

Cross‐sensitivityCompensationError* 0to40mmHg:±1mmHgadditionalerror

41to70mmHg:±2.5mmHgadditionalerror

71to100mmHg:±4mmHgadditionalerror

101to150mmHg:±5mmHgadditionalerror

*AdditionalworstcaseerrorwhencompensationforO2,N2O,

anestheticagents,orheliumiscorrectlyselectedfortheactual

fractionalgasconstituentspresent.

Alarm Limits

End‐tidalCO2

Lower

Upper

Offor5to60

5to80oroff

InspiredCO2 25(Fixed)

Respiration

Lower

Upper

Offor4to40

20to99oroff

GASorVapor Halothane Enflurane Isoflurane Desflurane

MACLevel%(v/v)0.74 1.68 2.00 6.30

Measured

Gas QuantitativeEffectsofGasorVapor

N20 HAL ENF ISO SEVO Xenon Helium DES Ethanol Isopropanol Acetone Methane

Carbon

Dioxide

NE@

60%

NE@

4%

NE@

5%

NE@

5%

NE@

5%

ME1

@80%

NE@

50%

ME2

@15%

NE@

0.1%

NE@

0.1%

NE@

0.1%

NE@

1%

NoEffect(NE)

MinimalEffect1(ME1)=NegativelybiasCarbonDioxidevaluesbyuptoanadditional5mmHgat38mmHg

MinimalEffect2(ME2)=Concentrationsgreaterthan5%willpositivelybiasCarbonDioxidevaluesbyuptoanadditional3mmHgat

38mmHg

*Metereddoseinhalerpropellants:Unspecified

ExpressionMR200InstructionsforUseSpecificationsA‐11

Bellows Respiration

RespirationRateMeasurementRange 0to60breathsperminute

RespirationRateResolution 1breathperminute

RespirationRateAccuracy ±1breathperminute

Gating Connector

PinDesignator SignalName DescriptionandCharacteristics

A DIGITALGATINGPULSE ECG/SPO2digitalgatingpulse

•Peaktopeakvoltage:3.3Vto5.0V

•Pulseduration:10±3ms

BSIGNALGROUND Returnvoltagereferenceforallothersignalpins

CRESPANALOG Analogrespirationgatingwaveformsignal

•Maximumoutputvoltage:±5V

•Maximumcurrent:5mA

•Peak

‐to‐peaksignalvoltage:1V

DECG1VANALOG AnalogECG1‐Voltwaveformsignal

•Outputsignalscaling:1V/mV

•Maximumoutputvoltage:±5V

•Maximumcurrent:5mA

F NEGATIVEGATINGPULSE ECG/SPO2negativedigitalgatingpulse

•Peak‐to‐peaksignalvoltage:‐3.3Vto‐5.0V

•AllothersignalcharacteristicssameasPinA(above)

GSPO240mVANALOG SPO2IR/redanaloggatingwaveformsignal

•Signalscaling:1V/mV

•Maximumoutputvoltage:40mV

HECG1mVANALOG ECGanaloggatingwaveformsignal

•Signalscaling:1mV/mV

•Maximumcurrent:5mA

•Maximumoutputvoltage:20mV

JSPO22VANALOG SPO2IR/redanaloggatingwaveformsignal,maximumoutput

voltage:2V

E,K,L,M,N,OUNUSED Unusedpins

Wiringview

A‐12SpecificationsExpressionMR200InstructionsforUse

ExpressionMR200InstructionsforUseWarrantyB‐1

APPENDIX B

Warranty

Warranty Statement

KoninklijkePhilipsN.V. warrantsthisproduct,otherthanitsconsumableparts,tobefreefrom

defectsinmaterialsandworkmanshipforaperiodoftwelve(12)monthsfromthedateof

originaldeliverytothebuyerortobuyer'sorder,providedthatsameisproperlyoperatedunder

conditionsofnormaluse,andthatperiodicmaintenanceandserviceisperformed.Thissame

warrantyismadeforaperiodofninety(90)daysonconsumableparts.Thiswarrantyshall

becomenullandvoidiftheMR200hasbeenrepairedbysomeoneotherthanKoninklijkePhilips

N.V. oriftheproducthasbeensubjecttomisuse,accident,negligenceorabuse.

KoninklijkePhilipsN.V.’ssoleobligationunderthiswarrantyislimitedtorepairinganMR200

whichhasbeenreportedtotheTechnicalServiceCenterduringnormalbusinesshoursand

shippedtransportationprepaid.KoninklijkePhilipsN.V. shallnotbeliableforanydamages

includingbutnotlimitedtoincidentaldamages,consequentialdamagesorspecialdamages.

Thiswarrantyisinlieuofanyotherwarranties,guaranteesorconditions,including

merchantabilityorfitnessforaparticularpurpose.Theremediesunderthiswarrantyare

exclusiveandKoninklijkePhilipsN.V. neitherassumesnorauthorizesanyonetoassumeforitany

otherobligationinconnectionwiththesaleorrepairofitsproducts.

KONINKLIJKEPHILIPSN.V. PRODUCTSCONTAINPROPRIETARYCOPYRIGHTEDMATERIAL.

ALLRIGHTSRESERVED

B‐2WarrantyExpressionMR200InstructionsforUse

ExpressionMR200InstructionsforUseRegulatoryInformationC‐1

APPENDIX C

Regulatory Information

European Union

Declaration of Conformity

ToobtainacopyoftheDeclarationofConformitytotheEuropeanUnionMedicalDevice

Directive(93/42/EEC)andRadio&TelecommunicationsTerminalEquipmentDirective(1999/5/

EC),and/orRestrictiononHazardousSubstance(RoHS)Directive,contacttheRegulatoryAffairs

DepartmentatInvivo:

407‐275‐3220

‐or‐

1‐800‐331‐3220(toll‐free)

Internationally,pleasecontactyourKeyMarketrepresentative.Gotowww.invivocorp.comfora

listing.

Authorized Representative

TheAuthorizedRepresentativefortheEuropeanUnion(asrequiredbytheMedicalDevice

Directive,93/42/EEC)isasfollows:

PhilipsMedizinSystemeBöblingenGmbH

Hewlett‐PackardStraße2

71034,Böblingen

Germany

Australia

TheAustraliaSponsorisasfollows:

PhilipsElectronicsAustraliaLtd

65EppingRoad,NorthRydeNSW2113

Australia

C‐2RegulatoryInformationExpressionMR200InstructionsforUse

ExpressionMR200InstructionsforUseGuidelinesandReferencesD‐1

APPENDIX D

Guidelines and References

Guidelines for the Prevention of Excessive Heating and Burns

Associated with Magnetic Resonance Procedures

Ingeneral,magneticresonance(MR)imagingisconsideredtobearelativelysafediagnostic

modality.However,theuseofradiofrequencycoils,physiologicmonitors,electronically‐

activateddevices,andexternalaccessoriesorobjectsmadefromconductivematerialshas

causedexcessiveheating,resultinginburninjuriestopatientsundergoingMRprocedures.

HeatingofimplantsandsimilardevicesmayalsooccurinassociationwithMRprocedures,but

thistendsbeproblematicprimarilyforobjectsmadefromconductivematerialsthathave

elongatedshapessuchasleads,guidewires,andcertaintypesofcatheters(e.g.,catheterswith

thermistorsorotherconductingcomponents).

Notably,morethan30incidentsofexcessiveheatinghavebeenreportedinpatientsundergoing

MRproceduresintheUnitedStatesthatwereunrelatedtoequipmentproblemsorthepresence

ofconductiveexternalorinternalimplantsormaterials[reviewofdatafilesfromU.S.Foodand

DrugAdministration,CenterforDevicesandRadiologicalHealth,ManufacturerandUserFacility

DeviceExperienceDatabase,MAUDE,http://www.fda.gov/cdrh/maude.htmlandU.S.Foodand

DrugAdministration,CenterforDevicesandRadiologicalHealth,MedicalDeviceReport,(http://

www.fda.gov/CDRH/mdrfile.html)].Theseincidentsincludedfirst,second,andthirddegree

burnsthatwereexperiencedbypatients.Inmanyofthesecases,thereportsindicatedthatthe

limbsorotherbodypartsofthepatientswereindirectcontactwithbodyradiofrequency(RF)

coilsorotherRFtransmitcoilsoftheMRsystemsortherewereskin‐to‐skincontactpoints

suspectedtoberesponsiblefortheseinjuries.

MRsystemsrequiretheuseofRFpulsestocreatetheMRsignal.ThisRFenergyistransmitted

readilythroughfreespacefromthetransmitRFcoiltothepatient.Whenconductingmaterials

areplacedwithintheRFfield,theresultmaybeaconcentrationofelectricalcurrentssufficient

tocauseexcessiveheatingandtissuedamage.Thenatureofhighfrequencyelectromagnetic

fieldsissuchthattheenergycanbetransmittedacrossopenspaceandthroughinsulators.

Therefore,onlydeviceswithcarefullydesignedcurrentpathscanbemadesafeforuseduring

MRprocedures.Simplyinsulatingconductivematerial(e.g.,wireorlead)orseparatingitfrom

thepatientmaynotbesufficienttopreventexcessiveheatingorburnsfromoccurring.

Furthermore,certaingeometricalshapesexhibitthephenomenonof“resonance”which

increasestheirpropensitytoconcentrateRFcurrents.Attheoperatingfrequenciesofpresent

dayMRsystems,conductingloopsoftensofcentimetersinsizemaycreateproblemsand,

therefore,mustbeavoided,unlesshighimpedanceisusedtolimitRFcurrent.Importantly,even

loopsthatincludesmallgapsseparatedbyinsulationmaystillconductcurrent.

Topreventpatientsfromexperiencingexcessiveheatingandpossibleburnsinassociationwith

MRprocedures,thefollowingguidelinesarerecommended:

D‐2GuidelinesandReferencesExpressionMR200InstructionsforUse

1. PreparethepatientfortheMRprocedurebyensuringthattherearenounnecessary

metallicobjectscontactingthepatient'sskin(e.g.,metallicdrugdeliverypatches,jewelry,

necklaces,bracelets,keychains,etc.).

2. PreparethepatientfortheMRprocedurebyusinginsulationmaterial(i.e.,appropriate

padding)topreventskin‐to‐skincontactpointsandtheformationof“closed‐loops”from

touchingbodyparts.

3. Insulatingmaterial(minimumrecommendedthickness,1cm)shouldbeplacedbetween

thepatient'sskinandtransmitRFcoilthatisusedfortheMRprocedure(alternatively,the

RFcoilitselfshouldbepadded).Forexample,positionthepatientsothatthereisnodirect

contactbetweenthepatient'sskinandthebodyRFcoiloftheMRsystem.Thismaybe

accomplishedbyhavingthepatientplacehis/herarmsoverhis/herheadorbyusingelbow

padsorfoampaddingbetweenthepatient'stissueandthebodyRFcoiloftheMRsystem.

ThisisespeciallyimportantforthoseMRexaminationsthatusethebodycoilorotherlarge

RFcoilsfortransmissionofRFenergy.

4. Useonlyelectricallyconductivedevices,equipment,accessories(e.g.,ECGleads,

electrodes,etc.),andmaterialsthathavebeenthoroughlytestedanddeterminedtobe

safeandcompatibleforMRprocedures,aslistedinthisIFU.

5. CarefullyfollowspecificMRsafetycriteriaandrecommendationsforimplantsmadefrom

electrically‐conductivematerials(e.g.,bonefusionstimulators,neurostimulationsystems,

etc.).

6. Beforeusingelectricalequipment,checktheintegrityoftheinsulationand/orhousingof

allcomponentsincludingsurfaceRFcoils,monitoringleads,cables,andwires.Preventive

maintenanceshouldbepracticedroutinelyforsuchequipment.

7. Removeallnon‐essentialelectricallyconductivematerialsfromtheMRsystem(i.e.,

unusedsurfaceRFcoils,ECGleads,cables,wires,etc.).

8. KeepelectricallyconductivematerialsthatmustremainintheMRsystemfromdirectly

contactingthepatientbyplacingthermaland/orelectricalinsulationbetweenthe

conductivematerialandthepatient.

9. KeepelectricallyconductivematerialsthatmustremainwithinthebodyRFcoilorother

transmitRFcoiloftheMRsystemfromformingconductiveloops.Note:Thepatient's

tissueisconductiveand,therefore,maybeinvolvedintheformationofaconductiveloop,

whichcanbecircular,U‐shaped,orS‐shaped.

10. Positionelectricallyconductivematerialstoprevent“crosspoints”.Forexample,across

pointisthepointwhereacablecrossesanothercable,whereacableloopsacrossitself,or

whereacabletoucheseitherthepatientorsidesofthetransmitRFcoilmorethanonce.

Notably,eventhecloseproximityofconductivematerialswitheachothershouldbe

avoidedbecausesomecablesandRFcoilscancapacitively‐couple(withoutanycontactor

crossover)whenplacedclosetogether.

11. PositionelectricallyconductivematerialstoexitdownthecenteroftheMRsystem(i.e.,

notalongthesideoftheMRsystemorclosetothebodyRFcoilorothertransmitRFcoil).

ExpressionMR200InstructionsforUseGuidelinesandReferencesD‐3

12. Donotpositionelectricallyconductivematerialsacrossanexternalmetallicprosthesis

(e.g.,externalfixationdevice,cervicalfixationdevice,etc.)orsimilardevicethatisindirect

contactwiththepatient.

13. Allowonlyproperlytrainedindividualstooperatedevices(e.g.,monitoringequipment)in

theMRenvironment.

14. Followallmanufacturerinstructionsfortheproperoperationandmaintenanceof

physiologicmonitoringorothersimilarelectronicequipmentintendedforuseduringMR

procedures.

15. ElectricaldevicesthatdonotappeartobeoperatingproperlyduringtheMRprocedure

shouldberemovedfromthepatientimmediately.

16. CloselymonitorthepatientduringtheMRprocedure.Ifthepatientreportssensationsof

heatingorotherunusualsensation,discontinuetheMRprocedureimmediatelyand

performathoroughassessmentofthesituation.

17. RFsurfacecoildecouplingfailurescancauselocalizedRFpowerdepositionlevelstoreach

excessivelevels.TheMRsystemoperatorwillrecognizesuchafailureasasetofconcentric

semicirclesinthetissueontheassociatedMRimageorasanunusualamountofimage

non‐uniformityrelatedtothepositionoftheRFcoil.

Theadoptionoftheseguidelineswillhelptoensurethatpatientsafetyismaintained,especially

asmoreconductivematerialsandelectronically‐activateddevicesareusedinassociationwith

MRprocedures.

References

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Anesthesiology1991;75:382‐3.

BrownTR,GoldsteinB,LittleJ.Severeburnsresultingfrommagneticresonanceimagingwith

cardiopulmonarymonitoring.Risksandrelevantsafetyprecautions.AmJPhysMedRehabil

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DempseyMF,CondonB,HadleyDM.Investigationofthefactorsresponsibleforburnsduring

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D‐4GuidelinesandReferencesExpressionMR200InstructionsforUse

FinelliDA,RezaiAR,RuggieriPM,TkachJA,NyenhuisJA,HrdlickaG,SharanA,Gonzalez‐Martinez

J,StypulkowskiPH,ShellockFG.MRimaging‐relatedheatingofdeepbrainstimulation

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HeinzW,FrohlichE,StorkT.Burnsfollowingmagneticresonancetomographystudy.(German)Z

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http://www.MRIsafety.com

InternationalElectrotechnicalCommission(IEC),MedicalElectricalEquipment,Particular

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InternationalStandardIEC60601‐2‐33,2002.

JonesS,JaffeW,AlviR.Burnsassociatedwithelectrocardiographicmonitoringduringmagnetic

resonanceimaging.Burns1996;22:420‐1.

KanalE,ShellockFG.BurnsassociatedwithclinicalMRexaminations.Radiology1990;175:585.

KanalE,ShellockFG.Policies,guidelines,andrecommendationsforMRimagingsafetyand

patientmanagement.JMagnResonImaging1992;2:247‐248.

KeensSJ,LaurenceAS.BurnscausedbyECGmonitoringduringMRIimaging.Anaesthesia

1996;51:1188‐9.

KnoppMV,EssigM,DebusJ,ZabelHJ,vanKaickG.Unusualburnsofthelowerextremities

causedbyaclosedconductingloopinapatientatMRimaging.Radiology1996;200:572‐5.

KnoppMV,MetznerR,BrixG,vanKaickG.Safetyconsiderationstoavoidcurrent‐inducedskin

burnsinMRIprocedures.(German)Radiologe199838:759‐63.

KugelH,BremerC,PuschelM,FischbachR,LenzenH,TombachB,VanAkenH,HeindelW.

HazardoussituationintheMRbore:inductioninECGleadscausesfire.EurRadiol2003;13:690‐

694.

NakamuraT,FukudaK,HayakawaK,AokiI,MatsumotoK,SekineT,UedaH,ShimizuY.

Mechanismofburninjuryduringmagneticresonanceimaging(MRI)‐simpleloopscaninduce

heatinjury.FrontMedBiolEng2001;11:117‐29

NyenhuisJA,KildishevAV,FosterKS,GraberG,AtheyW.Heatingnearimplantedmedicaldevices

bytheMRIRF‐magneticfield.IEEETransMagn1999;35:4133‐4135.

RezaiAR,FinelliD,NyenhuisJA,HrdlickG,TkachJ,RuggieriP,StypulkowskiPH,SharanA,

ShellockFG.Neurostimulatorfordeepbrainstimulation:ExvivoevaluationofMRI‐related

heatingat1.5‐Tesla.JournalofMagneticResonanceImaging2002;15:241‐250.

SchaeferDJ.SafetyAspectsofradio‐frequencypowerdepositioninmagneticresonance.MRI

ClinicsofNorthAmerica1998;6:775‐789.

SchaeferDJ,FelmleeJP.Radio‐frequencysafetyinMRexaminations,SpecialCross‐Specialty

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Physicists,andTechnologists,Syllabus,87thScientificoftheRadiologicalSocietyofNorth

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ShellockFG.MagneticResonanceProcedures:HealthEffectsandSafety.CRCPress,LLC,Boca

Raton,FL,2001.

ExpressionMR200InstructionsforUseGuidelinesandReferencesD‐5

ShellockFG.MRsafetyupdate2002:Implantsanddevices.JournalofMagneticResonance

Imaging2002;16:485‐496.

ShellockFG.Radiofrequency‐inducedheatingduringMRprocedures:Areview.Journalof

MagneticResonanceImaging2000;12:30‐36.

ShellockFG.ReferenceManualforMagneticResonanceSafety:2003Edition,Amirsys,Inc.,2003.

ShellockFG,SlimpG.SevereburnofthefingercausedbyusingapulseoximeterduringMRI.

AmericanJournalofRoentgenology1989;153:1105.

ShellockFG,HatfieldM,SimonBJ,BlockS,WamboldtJ,StarewiczPM,PunchardWFB.

Implantablespinalfusionstimulator:assessmentofMRIsafety.JournalofMagneticResonance

Imaging2000;12:214‐223.

SmithCD,NyenhuisJA,KildishevAV.Healtheffectsofinducedelectricalfields:implicationsfor

metallicimplants.In:ShellockFG,ed.Magneticresonanceprocedure:healtheffectsandsafety.

BocaRaton,FL:CRCPress,2001;393‐414.

U.S.FoodandDrugAdministration,CenterforDevicesandRadiologicalHealth(CDRH),Medical

DeviceReport(MDR)(http://www.fda.gov/CDRH/mdrfile.html).Thefilescontaininformation

fromCDRH'sdeviceexperiencereportsondeviceswhichmayhavemalfunctionedorcauseda

deathorseriousinjury.ThefilescontainreportsreceivedunderboththemandatoryMedical

DeviceReportingProgram(MDR)from1984‐1996,andthevoluntaryreportsuptoJune1993.

Thedatabasecurrentlycontainsover600,000reports.

U.S.FoodandDrugAdministration,CenterforDevicesandRadiologicalHealth(CDRH),

ManufacturerandUserFacilityDeviceExperienceDatabase,MAUDE,(http://www.fda.gov/cdrh/

maude.html).MAUDEdatarepresentsreportsofadverseeventsinvolvingmedicaldevices.The

dataconsistsofallvoluntaryreportssinceJune,1993,userfacilityreportssince1991,distributor

reportssince1993,andmanufacturerreportssinceAugust,1996.

D‐6GuidelinesandReferencesExpressionMR200InstructionsforUse

Notes

Invivo 2GMODSB WIRELESS ECG MODULE User Manual 989803184961

Invivo Corporation WIRELESS ECG MODULE 989803184961

USERS MANUAL

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