Invivo 2GMODSB WIRELESS ECG MODULE User Manual 989803184961

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Expression MR200 MRI Patient Monitoring System
INSTRUCTIONS FOR USE
Revision B
English
*989803184961*
989803184961
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.
ii
Contents
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
Contents 1
Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Wheel Locks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Battery Compartments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Guide Handles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient Connection Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Display and Control Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2-5
2-5
2-5
2-5
2-6
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Control Knob . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Status Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
LCD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Display Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Informational Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vital Sign Boxes Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
No Data Available Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Communication and Power Status Display Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vital Sign Traces Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2-11
2-11
2-12
2-12
2-13
2-13
2-14
2-14
2-15
2-16
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
2 Contents
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
Contents 3
SPO2 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
ALARM LIMITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SIZE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
AVERAGING TIME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
GATING SOURCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HR SOURCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HR TONE SOURCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5-10
5-11
5-11
5-12
5-12
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Selecting Auto Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Making Manual Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Initial Inflation Pressures and Reading Durations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stopping an NiBP Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6-5
6-5
6-6
6-6
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
INTERVAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
AUTO MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
FORMAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6-12
6-12
6-13
6-13
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
4 Contents
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
Contents 5
Graphical Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Viewing Individual Trend Graphical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Viewing Multi Trend Graphical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HISTORY Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PREV PAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
NEXT PAGE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CLEAR ALL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
MULTI TRENDS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TREND ARROWS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ARROW PERIOD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10-2
10-3
10-4
10-5
10-6
10-6
10-6
10-7
10-8
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sterilizing the Cart and Wireless Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cleaning the Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sterilizing the Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspecting the Accessories for Damage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Storing the Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11-2
11-4
11-4
11-5
11-6
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SIMULATION MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
NiBP TESTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
GAS CAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SERVICE UTILITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SYSTEM CONFIG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11-13
11-14
11-14
11-14
11-15
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
6 Contents
Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dimensions and Weights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Liquid Crystal Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A-2
A-3
A-3
A-3
Displayed Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4
ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4
ECG Amplifier. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Heart Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cardiotach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm Limits (HR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Test/Calibrations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ECG Supplemental Information, as required by IEC 60601-2-27. . . . . . . . . . . . . . . . . . . . . .
A-4
A-4
A-4
A-5
A-5
A-5
Pulse Oximeter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-6
Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
Non-Invasive Blood Pressure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-7
General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pneumatic Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Measurement Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accuracy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A-7
A-7
A-7
A-7
A-8
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 Resonance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3
Notes
Contents 7
8 Contents
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.
Expression MR200 Instructions for Use
Important Information 1‐1
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.
1‐2 Important Information
Expression MR200 Instructions for Use
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:
Step
Action
•
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.
Expression MR200 Instructions for Use
Important Information 1‐3
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.
1‐4 Important Information
Expression MR200 Instructions for Use
Safety
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.
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)
Expression MR200 Instructions for Use
Important Information 1‐5
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
Harmonic Emissions
IEC 61000-3-2
Class B
Voltage Fluctuations/flicker
emissions
IEC 61000-3-3
Complies
1‐6 Important Information
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.
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
Electromagnetic
Environment - Guidance
IEC 60601 Test Level
Compliance Level
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6kV contact
± 6kV contact
± 8kV air
± 8kV air
Electrical fast
transient/burst
IEC 61000-4-4
± 2kV for power supply lines
± 2kV for power supply lines
± 1kV for input/output lines
± 1kV for input/output lines
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
< 5% Ut
(> 95% dip in Ut) for 0.5 cycle
40% Ut
(60% dip in Ut) for 5 cycles
40% Ut
(60% dip in Ut) for 5 cycles
70% Ut
(30% dip in Ut) for 25 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 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.
3 A/m
3 A/m
Power
frequency (50/
60 Hz)
magnetic field
IEC 61000-4-8
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be at
least 30%.
Mains power quality should
be that of a typical
commercial or hospital
environment.
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.
Expression MR200 Instructions for Use
Important Information 1‐7
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
Conducted RF
IEC 61000-4-6
3 Vrms
150 KHz to 80 MHz
V1 = 3 Vrms
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
E1 = 3 V/m
Electromagnetic Environment - Guidance
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 recommended 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 reorienting or relocating the MR200.
Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
1‐8 Important Information
Expression MR200 Instructions for Use
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
1.167
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.
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.
Expression MR200 Instructions for Use
Important Information 1‐9
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
1‐10 Important Information
Expression MR200 Instructions for Use
Symbol
Meaning
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.
Symbol
Meaning
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
Expression MR200 Instructions for Use
Important Information 1‐11
Symbol
Meaning
Symbol
Meaning
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
1‐12 Important Information
Expression MR200 Instructions for Use
Symbol
Meaning
Symbol
Meaning
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, YYYYMM
Conforms to the RoHS
directive
Battery
Non-magnetic part
Wheel lock, press to engage
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.
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.
NiBP key
Expression MR200 Instructions for Use
Main key
mp
Trends key
Important Information 1‐13
Symbol
Meaning
Symbol
Meaning
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
1‐14 Important Information
Expression MR200 Instructions for Use
Symbol
Meaning
Symbol
Meaning
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
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
Expression MR200 Instructions for Use
Important Information 1‐15
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.)
1‐16 Important Information
Gating connector
USB port
AC inlet
Strain relief
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
Battery
compartments
Cart batteries
Important Information 1‐17
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).
Cart batteries
(If the battery does not
release, apply a slight
forward pressure on the
battery while pressing the
eject button.)
Battery eject buttons
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
Step
1‐18 Important Information
Action
Ensure that the cart batteries are installed; see page 1‐18 for
details.
Position the MR200; see page 2‐6.
Raise the strain relief.
Connect 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
Step
Action
Lower the strain relief over the AC power cord.
Connect the AC power cord to an approved AC mains outlet.
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.
Power level button
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.
Cart battery
Expression MR200 Instructions for Use
Important Information 1‐19
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.
SPO2 sensor
Screws
DB-9 connector
wSPO2 module
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.
1‐20 Important Information
Expression MR200 Instructions for Use
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.
Tabs
Slots
Battery
Module
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.
Tabs
Recess
Battery
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, each 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.)
Button area
Network icons
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.
Expression MR200 Instructions for Use
Important Information 1‐21
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.
Icon illuminated
•
Pressing the
button
Icon blinking
In the procedure below, the following illustrations are used to convey actions concerning
the use of the network button.
Releasing the
button
Pressing and holding
the button
Repeating
To change the network channel of a wireless module
Step
1‐22 Important Information
Action
Turn off the module by removing the battery; see page 1‐21.
Expression MR200 Instructions for Use
Step
Action
Insert 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).
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.
Press 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.
Expression MR200 Instructions for Use
Important Information 1‐23
Step
Action
When 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.
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.
1‐24 Important Information
Expression MR200 Instructions for Use
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
Expression MR200 Instructions for Use
Important Information 1‐25
CO2
REF
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
1‐26 Important Information
Expression MR200 Instructions for Use
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
PNEUMOGRAPH,CHEST,NM,3160
Expression MR200 Instructions for Use
REF
989803152791
Important Information 1‐27
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)
1‐28 Important Information
865471
Expression MR200 Instructions for Use
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
Expression MR200 Instructions for Use
Important Information 1‐29
1‐30 Important Information
Expression MR200 Instructions for Use
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).
Expression MR200 Instructions for Use
System Overview 2‐1
MRI magnet room
MR200
Modules to
MR200
(wireless)
Patient
bed
HIS system
MR200 to IP5 (wireless)
MRI control room
IP5
Printer
USB
Ethernet
Hospital network
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.
2‐2 System Overview
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
System Overview 2‐3
Display and control assembly
Speaker
Patient connection panel
Storage basket
Module holders
Guide handles
Wireless processing unit
Battery compartments
Rear panel
Wheel locks
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.
2‐4 System Overview
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
System Overview 2‐5
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.
NiBP port
CO2 port
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.
2‐6 System Overview
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
System Overview 2‐7
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.
wECG module
Status indicator
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.
wSPO2 module
Status indicator
Module Status Indicator
Each module has a status indicator, a two‐color LED, that denotes the following conditions.
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
NOTE
For battery details, see page 1-20; and, for communications details, see page 1-21.
2‐8 System Overview
Expression MR200 Instructions for Use
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
Step
Action
Ensure that a battery is installed in each wireless module (see page
1‐20).
With the cart batteries installed and with the MR200 connected to
AC power (see page 1‐18), press the power switch.
(Optional) if equipped, turn on the IP5.
Ensure that the network setting of each module (see page 1‐21)
matches the network setting of the MR200 (see on page 2‐16).
Ensure that the network setting of the IP5 (if turned on in step 3,
above) matches the network setting of the MR200 .
Ensure good communication between each module and the MR200
by checking the module’s status icon on the LCD (see on page 2‐
16).
(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.
Ensure proper operation of each patient parameter and alarms.
Refer to appropriate chapters in this manual.
CAUTION
If power to wireless device with established communications is lost or removed, its network
connection will be dropped.
Expression MR200 Instructions for Use
System Overview 2‐9
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.
Keypad
LCD
Control knob
Power switch
Status indicator
2‐10 System Overview
Expression MR200 Instructions for Use
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
Controls the alarm sound; see page 9-7 for details.
Silence
Enters suspend mode; see page 2-19 for details.
Suspend
NiBP
Begins a new NiBP measurement if no reading is in progress, or ends a
current measurement; see chapter 4.
Selects the type of patient to be monitored; see page 3-10 for details.
Patient
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).
Initiates a 30 second print when using an equipped IP5.
Print
Accesses the SETUP menu; see page 3-2 for details.
Setup
Closes any menu and returns to the normal operating mode (see page 2-18)
Main
Expression MR200 Instructions for Use
System Overview 2‐11
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
On
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.
2‐12 System Overview
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
System Overview 2‐13
Informational Area
The informational area, along the top of the screen, provides user and patient information:
Time
Symbol area
Current setup name
Patient
Notification area
•
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.
2‐14 System Overview
Expression MR200 Instructions for Use
ECG VS box (see page 4-16)
SPO2 VS box (see page 5-7)
CO2 VS box (see page 7-6)
NiBP VS box (see page 6-7)
RESP VS box (see page 8-3)
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.
Expression MR200 Instructions for Use
System Overview 2‐15
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:
wECG module
status icon
Cart
status icon
•
Network
icon
wSPO2 module
status icon
Printing
status icon
Printing status icon displays the status of the IP5 printer, when equipped:
– When ready to print,
– When printing,
until completion.
is displayed.
is displayed, indicating the time remaining (in seconds)
– When not installed or if a communication problem exists,
– When available but unable to print,
•
2‐16 System Overview
is displayed.
is displayed.
Cart status icon indicates the power status of the cart:
– Where
power.
indicates the cart has batteries installed and is operating on AC
– Where
power.
indicates the cart has no batteries installed and is operating on AC
Expression MR200 Instructions for Use
– 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.
Network
channel A
Network
channel B
Network
channel C
Network
channel D
Network
channel E
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.
Expression MR200 Instructions for Use
System Overview 2‐17
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
Trace B
Trace C
Trace D
System message area
•
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).
2‐18 System Overview
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
System Overview 2‐19
2‐20 System Overview
Expression MR200 Instructions for Use
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
Expression MR200 Instructions for Use
Getting Started 3‐1
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:
•
3‐2 Getting Started
ALARM SETUP (see chapter 9 for details)
Expression MR200 Instructions for Use
•
MONITOR SETUP (see below)
•
PRINTER SETUP (see chapter 10 for details)
MONITOR Menu
The MONITOR SETUP option (in the SETUP menu) opens the MONITOR menu, which contains
options for setup and control of patient monitoring.
MONITOR
menu
Setup key
Control knob
To change settings in the MONITOR menu
Step
Action
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Expression MR200 Instructions for Use
Getting Started 3‐3
Step
Action
Turn 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.
Turn the knob to the desired setting and then press the knob.
To change other settings, repeat steps 3 and 4.
Press the Main key
to close the menu.
Alternative: Turn the knob to RETURN and then press the knob, or
wait approximately 60 seconds.
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:
3‐4 Getting Started
•
•
•
•
Expression MR200 Instructions for Use
•
•
•
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
Step
Action
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Turn the control knob to RECALL SETUPS and then press the knob:
The RECALL SETUPS menu appears.
Turn the control knob to select one of the following memory blocks
and then press the knob:
USER
The selected memory block is recalled for the settings of the
MR200. (If displayed, the “+” symbol is removed.)
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
Expression MR200 Instructions for Use
Getting Started 3‐5
– 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:
•
•
•
•
•
•
•
USER
To store a setup in memory
Step
Action
Configure the settings and options of the MR200 as desired.
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Turn the control knob to STORE SETUPS and then press the knob:
The STORE SETUPS menu appears.
Turn the control knob to select one of the following memory blocks
and then press the knob:
USER
The configuration is stored in the selected memory block. (If
displayed, the “+” symbol is removed.)
3‐6 Getting Started
Expression MR200 Instructions for Use
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
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Turn the control knob to PARAMETER and press the knob.
The PARAMETER menu appears.
Expression MR200 Instructions for Use
Getting Started 3‐7
Step
Action
Turn 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.
Turn the knob to the desired setting and then press the knob.
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.)
3‐8 Getting Started
Expression MR200 Instructions for Use
•
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
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Turn the control knob to SOUND ADJUST and press the knob.
The SOUND ADJUST menu appears.
Turn 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.
Turn 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.
Expression MR200 Instructions for Use
Getting Started 3‐9
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.
Patient Type
Neonatal
Pediatric
Adult
Age
Birth to 28 days
29 days to 12 years
Greater than 12 years
Similarly, the Food & Drug Administration defines patients within two categories: pediatrics and
adults. Each category is further defined into subgroups according to approximate age.
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
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
3‐10 Getting Started
Expression MR200 Instructions for Use
– 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.
Expression MR200 Instructions for Use
Getting Started 3‐11
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.
Pediatric ECG
Patient Type
Condition
Off
Adult
Unlocked
On
Pediatric
Unlocked
On
Neonatal
Locked
To control the pediatric ECG filter
Step
Action
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Turn the control knob to PEDIATRIC ECG and press the knob.
The PEDIATRIC ECG menu appears.
Turn the control knob to the desired setting and then press the
knob.
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)
3‐12 Getting Started
•
SECOND sets the second.
•
MINUTE sets the minute.
•
HOUR sets the hour.
•
DAY sets the day.
Expression MR200 Instructions for Use
•
MONTH sets the month.
•
YEAR sets the year.
•
ENTER saves any changes.
To set the time and date
Step
Action
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Turn the control knob to SET TIME and press the knob.
The SET TIME menu appears.
Turn 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.
Turn the knob to the desired setting and then press the knob.
To change other settings, repeat steps 4 and 5.
Turn the control knob to ENTER and then press the knob.
The changes are saved.
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.
Expression MR200 Instructions for Use
Getting Started 3‐13
To set the default setups
Step
Action
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Turn the control knob to DEFAULT SETUPS and press the knob.
The DEFAULT SETUPS menu appears.
Turn the control knob to select one of the following options and
then press the knob:
FACTORY
USER
The power‐on default is set.
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:
3‐14 Getting Started
•
25 mm/s
•
12.5 mm/s (Default)
•
6.25 mm/s
•
3.125 mm/s
•
1.5625 mm/s
Expression MR200 Instructions for Use
•
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)
•
•
•
•
To set the network
Step
Action
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Turn the control knob to NETWORK and press the knob.
The NETWORK menu appears.
Turn the control knob to select one of the following options and
then press the knob:
The MR200 network channel is set.
Expression MR200 Instructions for Use
If 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.
Getting Started 3‐15
SERVICE(BIO-MED)
Allows access to pressure and miscellaneous configuration settings, diagnostic routines and
firmware information; see page 11‐12 for details.
3‐16 Getting Started
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
Monitoring ECG 4‐1
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).
4‐2 Monitoring ECG
Expression MR200 Instructions for Use
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).
Expression MR200 Instructions for Use
Monitoring ECG 4‐3
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.
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
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.
4‐4 Monitoring ECG
Expression MR200 Instructions for Use
Selecting sites on adult female patients
Average weight adult female
Overweight adult female
CV Quadtrode (preferred)
CV Quadtrode (preferred)
Standard Quadtrode
Standard Quadtrode
Selecting sites on adult male patients
Average weight adult male
Overweight adult male
CV Quadtrode (preferred)
CV Quadtrode (preferred)
Standard Quadtrode
Standard Quadtrode
Expression MR200 Instructions for Use
Monitoring ECG 4‐5
Selecting sites on pediatric patients
Pediatric female
Pediatric male
CV Quadtrode (preferred)
CV Quadtrode (preferred)
Standard Quadtrode
Standard Quadtrode
Selecting sites on infants and neonatal patients
Infants and Neonates
Standard Quadtrode
Neonatal Quadtrode*
*For patients weighing less than 22 pounds (10 kg)
4‐6 Monitoring ECG
Expression MR200 Instructions for Use
Preparing the ECG Site
To prepare an electrode site on a patient
Step
Action
Check the expiration date of the Quadtrode electrode package.
If necessary, shave the application area to remove hair from the
selected electrode site(s).
Apply ECG Skin Prep Gel (REF 989803152291) to a gauze pad.
Briskly rub the selected site(s) with the gauze pad (the skin may
turn pink).
Remove any excess gel with a clean gauze pad.
Follow the placement instructions provided on each Quadtrode
package. (Also reference the illustrations above.)
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.
Expression MR200 Instructions for Use
Monitoring ECG 4‐7
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.
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
The connection diagrams below illustrate placement of each type of ECG lead cable.
AHA Lead Cable Connections
IEC Lead Cable Connections
CAUTION
ECG clip leads should not be placed on the patient’s extremities.
4‐8 Monitoring ECG
Expression MR200 Instructions for Use
To attach the lead cable to the wECG module and lead cable clips to the Quadtrode electrode
Step
Action
Align 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.
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.
AHA lead cable
IEC lead cable
LL
RL
RA LA
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.
Check 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
Expression MR200 Instructions for Use
Monitoring ECG 4‐9
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.
LEAD FAIL message
LEAD FAIL indicator
(Example, left arm)
NOTE
If the RL electrode has lost contact (or if all electrodes have lost contact) then LL, LA, RA will be
the displayed indication.
4‐10 Monitoring ECG
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
Monitoring ECG 4‐11
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
4‐12 Monitoring ECG
Action
Arrange the ECG lead cable and the clip leads neatly, in a straight
alignment, with no looping.
Avoid contact between cables and bare skin.
Use only the ECG lead cables designated for use with this product;
see page 1‐ 26.
Minimize the use of multiple cables. (See the warnings on page 4‐
11 for details.)
Expression MR200 Instructions for Use
Step
Action
The 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.
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.
Use 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.
During measurement, check the patient to ensure that MRI‐related
heating is not occurring.
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).
Scale indicator
QRS complex
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.
Expression MR200 Instructions for Use
Monitoring ECG 4‐13
To change the SCALE setting
Step
Action
Press the Patient key
and then select the appropriate
PATIENT type; see page 3‐10 for details.
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.
Turn the control knob to SCALE and then press the knob.
The SCALE menu appears; see page 4‐21.
Turn 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.
Take 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.
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
4‐14 Monitoring ECG
Action
Verify the Quadtrode electrode date, quality and packaging.
Ensure that the preferred Quadtrode electrode and placement
site(s) are being used; see page 4‐4.
Expression MR200 Instructions for Use
Step
Action
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.
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.
Change the setting to a different lead view to account for patient
variability and then press the knob.
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.
If the amplitude did not improve, cycle through the remaining lead
views to a find the best signal amplitude by repeating step 5.
If the amplitude does not improve, remove the lead cable and
Quadtrode electrode and then prep the application site again.
Selecting the Filter Mode
Choose the appropriate ECG filter mode for your MRI study.
To change the filter mode setting
Step
Action
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.
Turn the control knob to FILTER MODE and then press the knob.
The FILTER MODE menu appears; see page 4‐23.
Expression MR200 Instructions for Use
Monitoring ECG 4‐15
Step
Action
Turn 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.
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:
12
13
14
15
11
10
Definition
4‐16 Monitoring ECG
Is the high limit setting of the HR (heart rate) alarm; see page 4-19
Is the heart rate measurement (numeric)
Is the low limit setting of the HR alarm; see page 4-19
Is the unit of measure for the heart rate, where BPM is beats per minute
Is the selected HR SOURCE; see page 4-22
Is the name of the vital sign
Is the detected ECG Trace B waveform
Is the scale indicator, a 1-millivolt signal reference (see SCALE on page 4-21)
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
Expression MR200 Instructions for Use
Definition
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
Changing the Waveform Speed
To change the ECG (and SPO2) waveform speed
Step
Action
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Turn the knob to SWEEP SPEED and then press the knob.
The SWEEP SPEED menu appears; see page 3‐14.
Turn 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.
Changing the Heart Rate Alarm Limits
To change the heart rate alarm limit settings
Step
Action
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.
Turn 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.
Turn the knob to the low or high setting and then press the knob.
The setting is selected.
Expression MR200 Instructions for Use
Monitoring ECG 4‐17
Step
Action
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.
To change the remaining setting, repeat steps 3 and 4.
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
Step
Action
Turn the control knob to highlight the ECG VS box and then press
the knob.
The ECG menu appears. Current settings are displayed.
4‐18 Monitoring ECG
Expression MR200 Instructions for Use
Step
Action
Turn 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.
Turn the knob to the desired setting and then press the knob.
To change other settings, repeat steps 2 and 3.
Press the Main key
to close the menu.
Alternative: Turn the knob to RETURN and then press the knob, or
wait approximately 60 seconds.
ALARM LIMITS
Controls the alarm limit settings for heart rate. (See the table on page 9‐15 for a listing.)
Definition
Expression MR200 Instructions for Use
Is the setting of the high alarm limit
Is the current measurement
Is the setting of the low alarm limit
Monitoring ECG 4‐19
Definition
Saves the settings then returns to the normal mode
Identifies heart rate alarm limits
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:
•
•
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:
4‐20 Monitoring ECG
•
•
II
•
III
•
AVL
•
AVR
•
AVF
•
OFF (Default)
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
Monitoring ECG 4‐21
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
Step
Action
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.
Turn the control knob to HR SOURCE and then press the knob.
The HR SOURCE menu appears.
Turn the control knob to select one of the following options and
then press the knob:
AUTO
ECG
SPO2
The setting is changed.
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).
4‐22 Monitoring ECG
Expression MR200 Instructions for Use
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
Expression MR200 Instructions for Use
Monitoring ECG 4‐23
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
4‐24 Monitoring ECG
•
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
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.
Expression MR200 Instructions for Use
Monitoring ECG 4‐25
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
Verify 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
Ensure 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.)
4‐26 Monitoring ECG
Expression MR200 Instructions for Use
Using SPO2 Gating
To receive SPO2 gating signals
Step
Action
Verify 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
Ensure that the SPO2 attachment is properly attached; see Apply‐
ing the SPO2 Attachment to the Patient on page 5‐3.
Turn 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.
Turn the control knob to GATING SOURCE and then press the knob.
The GATING SOURCE menu appears; see page 5‐12.
Turn the knob to PULSE and then press the knob.
The setting is applied.
Expression MR200 Instructions for Use
Monitoring ECG 4‐27
4‐28 Monitoring ECG
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
Monitoring SPO2 5‐1
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
Fiber heads
SPO2 attachment (clip
shown)
5‐2 Monitoring SPO2
Expression MR200 Instructions for Use
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
Expression MR200 Instructions for Use
Action
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.
If present, remove any colored nail polish from the application site.
Press the clip to open.
Push 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.)
Ensure that the finger is touching the stop at the cushion and lays
nicely centered in the clip.
Monitoring SPO2 5‐3
To apply a disposable clip to the patient
Step
Action
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.
If present, remove any colored nail polish from the application site.
Lift off the release liners that protect the adhesive.
Put 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.
Close 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.
Wrap the foam wings around the
finger and attachment and stick to
the opposing grip side. Do not stretch
the foam to apply excessive pressure.
To apply a disposable neonate clip to the patient
Step
5‐4 Monitoring SPO2
Action
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.
Lift off the release liners that protect the adhesive.
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.
With 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.
Press both fiber heads gently to attach
the adhesives.
Expression MR200 Instructions for Use
Step
Action
Secure the longer foam piece by pressing it firmly to the foam/
adhesive of the opposing side.
Ensure 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.
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
Step
Expression MR200 Instructions for Use
Action
Ensure 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.
Swivel each fiber head into a position that causes the least bending
of the cable while providing the most comfort to the patient.
Monitoring SPO2 5‐5
Step
Action
Verify 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
Press the Patient key
and then select the appropriate
PATIENT type; see page 3‐10 for details.
5‐6 Monitoring SPO2
Check for any displayed SPO2 messages and, if a message is
present, follow the recommended action to achieve better results
(see page 9‐16).
While considering the scan to be
performed, place the wSPO2 module on or
near the patient and as close as possible to
the bore opening. Keep the sensor and
module outside the field of view.
Place the module as close as possible to the bore opening. (If the
module can be placed outside the bore, positioning at the iso‐
center is not necessary.)
Place the module on a cushioned surface to minimize MR
vibrations.
Cover 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.
Expression MR200 Instructions for Use
SPO2 Waveform and VS Box
The elements contained in the SPO2 waveform (Trace C) and VS box are described below:
Definition
Is the high limit setting of the SPO2 alarm; see page 5-10
Is the low limit setting of the SPO2 alarm; see page 5-10
Is the heart rate numeric and the unit of measure, where BPM is beats per minute.
Is the name of the vital sign
Is the detected SPO2 waveform, not proportional to pulse volume and can be
amplitude-adjusted for viewing; see page 5-8.
Is the SPO2 measurement (numeric), given as a percentage
Changing the Waveform Speed
To change the SPO2 (and ECG) waveform speed
Step
Action
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Turn the knob to SWEEP SPEED and then press the knob.
The SWEEP SPEED menu appears; see page 3‐14.
Turn 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.
Expression MR200 Instructions for Use
Monitoring SPO2 5‐7
Changing the SPO2 Waveform Amplitude
To change the SPO2 waveform amplitude
Step
Action
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.
Turn the control knob to SIZE and then press the knob.
The SIZE menu appears; see page 5‐11 for details.
Turn 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.
Changing the SPO2 Alarm Limits
To change the SPO2 alarm limit settings
Step
Action
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.
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.
Turn the knob to the low or high setting and then press the knob.
The setting is selected.
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.
To change the remaining setting, repeat steps 3 and 4.
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.
5‐8 Monitoring SPO2
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
Monitoring SPO2 5‐9
To change settings in the SPO2 menu
Step
Action
Turn the control knob to highlight the SPO2 VS box and then press
the knob.
The SPO2 menu appears. Current settings are displayed.
Turn 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.
Turn the knob to the desired setting and then press the knob.
To change other settings, repeat steps 2 and 3.
Press the Main key
to close the menu.
Alternative: Turn the knob to RETURN and then press the knob, or
wait approximately 60 seconds.
ALARM LIMITS
Controls the SPO2 alarm limit settings. (See the table on page 9‐15 for a listing.)
5‐10 Monitoring SPO2
Expression MR200 Instructions for Use
Definition
Is the setting of the high alarm limit
Is the current measurement
Is the setting of the low alarm limit
Saves the settings and returns to the normal mode
Identifies SPO2 alarm limits
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:
•
5S
•
10 S (Default)
•
15 S
Expression MR200 Instructions for Use
Monitoring SPO2 5‐11
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
Turn 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.
Turn the control knob to HR SOURCE and then press the knob.
The HR SOURCE menu appears.
5‐12 Monitoring SPO2
Expression MR200 Instructions for Use
Step
Action
Turn the control knob to select one of the following options and
then press the knob:
AUTO
ECG
SPO2
The setting is changed.
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.)
Expression MR200 Instructions for Use
Monitoring SPO2 5‐13
5‐14 Monitoring SPO2
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
Monitoring NiBP 6‐1
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.
6‐2 Monitoring NiBP
Expression MR200 Instructions for Use
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).
Index line
Circumference
range
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.
Range line
Artery mark
All patients—align the cuff to ensure the
artery mark is placed over the artery.
NiBP cuff
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.
Expression MR200 Instructions for Use
Monitoring NiBP 6‐3
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
6‐4 Monitoring NiBP
Action
Insert the
appropriate
interconnect hose
connector onto the
NiBP port. Push the
hose connector
forward and then
turn it clockwise.
NiBP port
Attach a NiBP cuff appropriate for the patient type and size to the
interconnect hose.
Expression MR200 Instructions for Use
Step
Action
Position the cuff on the patient; see page 6‐4.
Ensure that the cuff and interconnect hoses are not kinked.
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
Step
Action
Press the Patient key
and then select the appropriate
PATIENT type; see page 3‐10 for details.
Turn 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.
Turn the control knob to INTERVAL and then press the knob.
The INTERVAL menu appears. The current setting is highlighted.
Turn 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.
Expression MR200 Instructions for Use
Turn the control knob to AUTO MODE and then press the knob.
Turn the control knob to ON and then press the knob.
Press the NiBP key
to begin measurements.
Monitoring NiBP 6‐5
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
Step
Action
Press the Patient key
and then select the appropriate
PATIENT type; see page 3‐10 for details.
Press the NiBP key
to start and stop a manual NiBP
measurement.
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.
6‐6 Monitoring NiBP
Expression MR200 Instructions for Use
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.
10
11
7 6
5 4
Definition
Is the NiBP diastolic pressure measurement (numeric)
Is the low limit of the NiBP diastolic alarm setting; see page 6-12
Is the high limit of the NiBP diastolic alarm setting; see page 6-12
Is the low limit of the NiBP systolic alarm setting; see page 6-12
Is the high limit of the NiBP systolic alarm setting; see page 6-12
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
Is the time since the last completed NiBP reading, displayed in the following format:
::, where
 = Two-digit hours field
 = Two-digit minutes field
 = Two-digit seconds field
NOTE
During a reading, this displays the cuff pressure.
Expression MR200 Instructions for Use
Monitoring NiBP 6‐7
Definition
Is the name of the vital sign
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:
::, where
 = Two-digit hours field
 = Two-digit minutes field
 = Two-digit seconds field
10
Is the NiBP mean pressure measurement (numeric)
11
Is the NiBP systolic pressure measurement (numeric)
Mean Format
The elements contained in the MEAN format are described below.
5 4
Definition
Is the NiBP mean pressure measurement (numeric)
Is the high limit of the NiBP mean alarm setting; see page 6-12
Is the low limit of the NiBP mean alarm setting; see page 6-12
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
Is the time since the last completed NiBP reading, displayed in the following format:
::, where
 = Two-digit hours field
 = Two-digit minutes field
 = Two-digit seconds field
NOTE
During a reading, this displays the cuff pressure.
6‐8 Monitoring NiBP
Is the name of the vital sign
Expression MR200 Instructions for Use
Definition
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:
::, where
 = Two-digit hours field
 = Two-digit minutes field
 = Two-digit seconds field
Is the NiBP systolic pressure measurement (numeric)
Is the NiBP diastolic pressure measurement (numeric)
Changing the NiBP Alarm Limits
To change the NiBP alarm limit settings
Step
Action
Turn 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.
Turn 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.
Turn the knob to the low or high setting and then press the knob.
The measurement and setting are selected.
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.
To change other alarm settings, repeat steps 3 and 4.
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.
Expression MR200 Instructions for Use
Monitoring NiBP 6‐9
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
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Turn the control knob to SERVICE(BIO‐MED) and press the knob.
The SERVICE(BIO‐MED) menu appears.
Turn the control knob to SYSTEM CONFIG and press the knob.
The SYSTEM CONFIG submenu appears. Current settings are
displayed.
Turn the control knob to PRESSURE UNITS and then press the knob.
The PRESSURE UNITS menu appears. The current setting is
highlighted.
Turn the knob to the desired setting and then press the knob.
mmHg
kPa
The setting is selected.
Press the Main key
to close the menu.
Alternative: Turn the knob to RETURN and then press the knob.
6‐10 Monitoring NiBP
Expression MR200 Instructions for Use
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
Turn the control knob to highlight the NiBP VS box and then press
the knob.
The NiBP menu appears. Current settings are displayed.
Turn 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.
Turn the knob to the desired setting and then press the knob.
To change other settings, repeat steps 2 and 3.
Press 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
Monitoring NiBP 6‐11
ALARM LIMITS
Controls the alarm limit settings for NiBP. (See the table on page 9‐15 for a listing.)
Definition
Are the settings of the high alarm limits
Are the current measurements
Are the settings of the low alarm limits
Saves the settings and returns to the normal mode
Identifies diastolic alarm limits
Identifies mean alarm limits
Identifies NiBP alarm limits
Identifies systolic alarm limits
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:
6‐12 Monitoring NiBP
•
1 Minute
•
2 Minutes
•
2.5 Minutes
•
3 Minutes (Default)
•
5 Minutes
•
10 Minutes
Expression MR200 Instructions for Use
•
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.
Expression MR200 Instructions for Use
Monitoring NiBP 6‐13
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
Turn 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.
Turn the control knob to FORMAT and then press the knob.
The FORMAT menu appears. The current setting is highlighted.
Turn the control knob to select from the following settings and then
press the knob:
SYS/DIA
MEAN
The selection is entered.
6‐14 Monitoring NiBP
Expression MR200 Instructions for Use
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
Expression MR200 Instructions for Use
Monitoring CO2 7‐1
•
All accessories are single use.
Connecting the Sampling Line
To connect the sampling line
Step
Action
Insert the sampling line connector
into the CO2 port and then push the
connector forward until you feel or
hear it click into place.
CO2 port
Sampling line connector
If CO2 WARMING UP is displayed, wait as the system thermally
stabilizes. When the message is cleared, CO2 is fully operational.
Always 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.
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.
7‐2 Monitoring CO2
•
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.
Expression MR200 Instructions for Use
•
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
Expression MR200 Instructions for Use
Action
Ensure that the sampling line is clean, dry and undamaged. Replace
the line if necessary.
Insert the sampling line connector into the CO2 port (see page 7‐2).
A click will be heard when properly inserted.
Monitoring CO2 7‐3
Step
Action
Place the sampling line onto the patient, as shown below.
If using the sampling line with the airway adapter, proceed to step
5; otherwise go to step 7.
Place 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.
Press the Patient key
and then select the appropriate
PATIENT type; see page 3‐10 for details.
7‐4 Monitoring CO2
Expression MR200 Instructions for Use
Step
Action
Check 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.
If the following warning is displayed:
Persistent CO2 occlusion detected.
Please clear occlusion and press OK
to resume using CO2
Clear any pinches or obstructions in the sampling line before
proceeding.
Expression MR200 Instructions for Use
Monitoring CO2 7‐5
CO2 Waveform and VS Box
The elements contained in the CO2 waveform (Trace D) and VS box are described below.
6 5
Definition
Is the high limit setting of the CO2 alarm; see page 7-9
Is the low limit setting of the CO2 alarm; see page 7-9
Is the inspired FiCO2 (inspired CO2) measurement (numeric)
Is the unit of measure for the CO2 numeric data, where mmHg is millimeters of
mercury and kPa is kilopascals; see page 7-11
Is the label for the FiCO2 measurement
Is the name of the vital sign
Is the detected CO2 waveform
Is the label for the EtCO2 measurement
Is the EtCO2 (expired CO2) measurement (numeric)
Changing the Waveform Speed
To change the CO2 waveform speed
Step
Action
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
7‐6 Monitoring CO2
Expression MR200 Instructions for Use
Step
Action
Turn the knob to RESP SPEED and then press the knob.
The RESP SPEED menu appears. The current setting is highlighted.
Turn 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.
Changing the CO2 Alarm Limits
To change the End‐tidal CO2 alarm limit settings
Step
Action
Turn 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.
Turn 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.
Turn the knob to the low or high setting and then press the knob.
The setting is selected.
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.
To change the remaining setting, repeat steps 3 and 4.
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.
Expression MR200 Instructions for Use
Monitoring CO2 7‐7
Changing the Unit of Measure
To change the unit of measure
Step
Action
Turn the control knob to highlight the CO2 VS box (see below) and
then press the knob.
The CO2 menu appears. Current settings are displayed.
Turn the control knob to UNIT and then press the knob.
The UNIT menu appears. The current setting is highlighted.
Turn the knob to select one of the following CO2 settings:
mmHg
kPa
The setting is selected.
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
Turn the control knob to highlight the CO2 VS box and then press
the knob.
The CO2 menu appears. Current settings are displayed.
7‐8 Monitoring CO2
Expression MR200 Instructions for Use
Step
Action
Turn 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.
Turn the knob to the desired setting and then press the knob.
To change other settings, repeat steps 2 and 3.
Press the Main key
to close the menu.
Alternative: Turn the knob to RETURN and then press the knob, or
wait approximately 60 seconds.
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.)
Definition
Expression MR200 Instructions for Use
Is the setting of the high alarm limit
Is the current measurement
Is the setting of the low alarm limit
Saves the settings and returns to the normal mode
Identifies expired CO2 alarm limits
Monitoring CO2 7‐9
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.
Size
Grid
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.
7‐10 Monitoring CO2
Expression MR200 Instructions for Use
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
Step
Action
Ensure that CO2 WARMING UP is not displayed.
Turn the control knob to highlight the CO2 VS box and then press
the knob.
The CO2 menu appears. Current settings are displayed.
Turn 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.
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.
Expression MR200 Instructions for Use
Monitoring CO2 7‐11
7‐12 Monitoring CO2
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
Monitoring RESP 8‐1
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
Place the sensor on the patient’s upper abdomen or lower chest
(whichever expands most during inspiration).
After the patient has exhaled, place the velcro strap around the
patient’s trunk and secure the sensor snuggly.
Connect the flexible hose to the pneumatic respiration port on the
wSPO2 module.
Pneumatic respiration port
Status indicator
Check 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
8‐2 Monitoring RESP
Expression MR200 Instructions for Use
Step
Action
Press the Patient key
and then select the appropriate
PATIENT type (see page 3‐10 for details).
Check the respiratory signal before the patient is placed in the MR
system.
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).
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.
Definition
Is the high limit setting of the respiration alarm (not present with bellows respiration);
see page 8-5
Is the low limit setting of the respiration alarm (not present with bellows respiration);
see page 8-5
Expression MR200 Instructions for Use
Monitoring RESP 8‐3
Definition
Is the unit type for the respiration numeric data, where RPM is respirations per minute
Is the source used for the respiration monitoring, where CO2 is CO2-derived, and BEL
is bellows-derived; see page 8-6
Is the name of the vital sign/parameter
Is the respiration rate measurement (numeric)
Changing RESP Alarm Limits
To change the RESP alarm limit settings
Step
Action
Turn 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.
Turn 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.
Turn the knob to the low or high setting and then press the knob.
The setting is selected.
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.
To change the remaining setting, repeat steps 3 and 4.
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.
8‐4 Monitoring RESP
Expression MR200 Instructions for Use
RESP Menu
The RESP menu allows you to control respiration functions and settings.
To change settings in the RESP menu
Step
Action
Turn the control knob to highlight the RESP VS box and then press
the knob.
The RESP menu appears. Current settings are displayed.
Turn 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.
Turn the knob to the desired setting and then press the knob.
To change other settings, repeat steps 2 and 3.
Press the Main key
to close the menu.
Alternative: Turn the knob to RETURN and then press the knob, or
wait approximately 60 seconds.
ALARM LIMITS
Controls the alarm limit settings for CO2‐derived respiration. (See the table on page 9‐15 for a
listing.)
Expression MR200 Instructions for Use
Monitoring RESP 8‐5
5
Definition
Is the setting of the high alarm limit
Is the current measurement
Is the setting of the low alarm limit
Saves the settings and returns to the normal mode
Identifies CO2-derived respiration rate alarm limits
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.
8‐6 Monitoring RESP
Expression MR200 Instructions for Use
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).
Expression MR200 Instructions for Use
Alarms 9‐1
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.
Definition
Violated numeric
Violated alarm limit
Violated waveform
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.
9‐2 Alarms
Expression MR200 Instructions for Use
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).
Expression MR200 Instructions for Use
Alarms 9‐3
To change the alarm limit display
Step
Action
Press the SETUP key
The SETUP menu appears.
With ALARM SETUP highlighted, press the control knob.
The ALARMS menu appears. Current settings are displayed.
Turn the knob to LIMITS DISPLAY and then press the knob.
Scroll to the desired setting and press the knob.
The setting is selected.
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).
9‐4 Alarms
Expression MR200 Instructions for Use
To adjust the alarm limit settings for all monitored parameters
Step
Action
With the patient connected to the MR200 and with
the desired parameters turned on, press the SETUP key
The SETUP menu appears.
With ALARM SETUP highlighted, press the control knob.
The ALARMS menu appears. Current settings are displayed.
Turn the knob to UPPER WINDOW and then press the knob.
The current setting is highlighted.
Scroll to the desired percentage and press the knob. The following
choices are available:
5%
10%
15%
20%
30%
The setting is selected.
Turn the knob to LOWER WINDOW and then press the knob.
The current setting is highlighted.
Scroll to the desired percentage and press the knob. The following
choices are available:
5%
10%
15%
20%
30%
The setting is selected.
Scroll to CALCULATE ALL then press the knob.
All active alarm limit settings are changed.
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).
Expression MR200 Instructions for Use
Alarms 9‐5
To adjust the alarm limit settings for a single parameter (using the ALARMS menu)
Step
Action
Press the SETUP key
The SETUP menu appears.
With ALARM SETUP highlighted, press the control knob.
The ALARMS menu appears. Current settings are displayed.
With SET INDIVIDUAL highlighted, press the knob.
The cursor highlights a low alarm limit setting in the menu.
Turn 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.
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.
To change any remaining settings, repeat steps 4 and 5.
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
With a monitored patient connected to the MR200, press the
SETUP key
The SETUP menu appears.
With ALARM SETUP highlighted, press the control knob.
The ALARMS menu appears. Current settings are displayed.
Turn the knob to DEFAULT LIMITS and press the knob.
The alarm settings are returned to the default values.
9‐6 Alarms
Expression MR200 Instructions for Use
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
Step
Action
Press the SETUP key
The SETUP menu appears.
Turn the knob to MONITOR SETUP and press the control knob.
The MONITOR menu appears. Current settings are displayed.
Turn the knob to SOUND ADJUST and press the knob.
The SOUND ADJUST menu appears. The current settings are
displayed.
Turn 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.
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
Expression MR200 Instructions for Use
Alarms 9‐7
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.
9‐8 Alarms
Expression MR200 Instructions for Use
ALARMS
menu
Setup key
Control knob
To change settings in the ALARMS menu
Step
Action
Press the SETUP key
The SETUP menu appears.
With ALARM SETUP highlighted, press the control knob.
The ALARMS menu appears. Current settings are displayed.
Turn 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.
Expression MR200 Instructions for Use
Turn the knob to the desired setting and then press the knob.
Alarms 9‐9
Step
Action
To change other options, repeat steps 3 and 4.
Press the Main key
to close the menu.
Alternative: Turn the knob to RETURN and then press the knob, or
wait approximately 60 seconds.
SET INDIVIDUAL
Controls the alarm limit settings for individual parameters.
Definition
Identifies the parameter
Are the current settings of the low alarm limits
Are the current readings of the patient
Are the current settings of the high alarm limits
Exits the menu
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.
9‐10 Alarms
Expression MR200 Instructions for Use
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
Expression MR200 Instructions for Use
Alarms 9‐11
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
(Default)
indicates that the sound has been enabled.
•
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
Step
Action
Press the SETUP key
The SETUP menu appears.
With ALARM SETUP highlighted, press the control knob.
The ALARMS menu appears. Current settings are displayed.
Turn the control knob to ALARM SOUND and then press the knob:
Turn the knob to the desired setting and then press the knob.
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.
9‐12 Alarms
Expression MR200 Instructions for Use
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
Expression MR200 Instructions for Use
Action
With the monitor turned on and not in suspend mode, make sure all
alarms are enabled (ALARM SOUND is not off, silenced, or on hold).
Make sure the lower SPO2 alarm limit is not set to OFF.
Alarms 9‐13
Step
Action
Verify 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
Place the SPO2 attachment on your finger and wait for a value to
appear in the SPO2 VS box.
Remove the clip from your finger.
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.
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.
Adjustable Alarm Limit Ranges
Vital Sign or
Parameter
Unit
Low Alarm Limit *
High Alarm Limit *
Minimum
Maximum
Minimum
Maximum
BPM
Off, 30
249
60
249, Off
CO2 (End-tidal)**
mmHg
kPa
Off, 5
Off, 0.7
60
8.0
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
Heart Rate
9‐14 Alarms
Expression MR200 Instructions for Use
Adjustable Alarm Limit Ranges
Vital Sign or
Parameter
Low Alarm Limit *
Unit
High Alarm Limit *
Minimum
Maximum
Minimum
Maximum
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
*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.
Factory Default Alarm Limits*
Vital Sign or
Parameter
Neonate
Pediatric
Adult
Unit
Low
Limit
High
Limit
Low
Limit
High
Limit
Low
Limit
High
Limit
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
40
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
Heart Rate
Expression MR200 Instructions for Use
Alarms 9‐15
Factory Default Alarm Limits*
Neonate
Vital Sign or
Parameter
Pediatric
Adult
Unit
Low
Limit
High
Limit
Low
Limit
High
Limit
Low
Limit
High
Limit
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
* 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.
Displayed Message/
Indication
Message
Location
ALARM SILENCED
System message
area
Type
Probable Cause
Recommended Action
The Silence key was
pressed.
Wait until the 120-second countdown
completes or press the Silence key.
The SPO2 sensor is
defective.
Replace the SPO2 sensor.
NOTE
No alarm sound
generated
BAD PROBE
9‐16 Alarms
SPO2 VS box
Expression MR200 Instructions for Use
Displayed Message/
Indication
Message
Location
CHANGE NiBP CUFF
Notification
area
CHECK ALARM VOL
Probable Cause
Recommended Action
The PATIENT type was
changed and this message is
displayed as a reminder.
Ensure the correct cuff size is used for
the patient.
System message
area
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
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
NiBP internal error
Discontinue use of NiBP and contact
technical support.
CO2 CAL FAIL
Notification
area
CO2 calibration has failed.
Retry calibration. If the problem
persists, contact technical support.
CO2 Hardware Fail
Notification
area
CO2 module was not found
during initialization
Contact technical support.
CO2 OUT OF RANGE
Notification
area
The calculation value is greater Perform patient readings to confirm
than the upper CO2 limit .
physiological condition.
CO2 SENSOR FAULTY Notification
area
CO2 bench detected a
hardware or sensor error.
Contact technical support.
CO2 SENSOR OVER
TEMP
CO2 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.
Notification
area
Type
If the problem persists, stop all
monitoring activities and contact
technical support.
CO2 WARMING UP
Notification
area
Displayed 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
Zero calibration of the CO2
module is needed
Perform a zero calibration; see page 711.
DEFL TO
NiBP VS box
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
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
NiBP hardware failure
Expression MR200 Instructions for Use
Discontinue use of NiBP and contact
technical support.
Alarms 9‐17
Displayed Message/
Indication
Message
Location
HW FAIL
NiBP VS box
HW FAIL
INFL TO
Probable Cause
Recommended Action
A hardware or other error
has occurred in the NiBP
system.
Discontinue use of NiBP and contact
technical support.
SPO2 VS box
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.
NiBP VS box
NiBP inflation has timed out.
Internal CO2 Occlusion Notification
area
The internal filter has become
polluted or disconnected.
INTRFERNCE
SPO2 VS box
Interference due to
misalignment of the
attachment’s light source and
receiver, or incorrect
positioning of the attachment
on the patient.
LEAD FAIL
ECG trace
area
A faulty or disconnected
ECG lead is detected.
9‐18 Alarms
Type
NOTE
NOTES
If the heart
rate source is
set to ECG, no
HR value will
be displayed in
the ECG VS
box.
An inoperative ECG
parameter or wECG module
is indicated by absence of an
ECG waveform and a
simultaneous Lead Fail
alarm.
• Check the patient.
• Check the cuff and hoses for
pinching or leaks.
• If the message persists, contact
technical support.
Contact technical support.
• 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).
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.
Expression MR200 Instructions for Use
Displayed Message/
Indication
Message
Location
LEAD SATURATION
ECG trace
area
Type
Reported within 10 seconds, Replace the Quadtrode electrode.
the baseline offset of the ECG
input signal is too large for the
system to process and display
the waveform.
Accuracy may be
compromised due to low
perfusion. The tissue at the
site may be too opaque, thick
or cold.
If the heart
rate source is
set to ECG, no
HR value will
be displayed in
the ECG VS
box.
SPO2 VS box
Recommended Action
NOTE
LOW PERF
Probable Cause
NOTE
No alarm
sound
generated
• 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
NiBP is not calibrated.
Contact technical support.
MSMT FAIL
NiBP VS box
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
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
NiBP: DEFLATION
TIMEOUT
Notification
area
NiBP: HARDWARE
ERROR
NiBP: INFLATION
TIMEOUT
Same as COMM ERR
See COMM ERR for details.
Same as DEFL TO
See DEFL TO for details.
Notification
area
Same as HW ERR
See HW ERR for details.
Notification
area
Same as INFL TO
See INFL TO for details.
Expression MR200 Instructions for Use
Alarms 9‐19
Displayed Message/
Indication
Message
Location
Type
Probable Cause
Recommended Action
NiBP: MEASUREMENT Notification
FAILED
area
Same as MSMT FAIL
See MSMT FAIL for details.
NiBP: MEASUREMENT Notification
TIMEOUT
area
Same as MSMT TO
See MSMT TO for details.
NiBP: OVER
PRESSURE
Notification
area
Same as OVR PRESS
See OVR PRESS for details.
NiBP: PRESSURE
Notification
CORRECTION ERROR area
Same as PRESS CORR
See PRESS CORR for details.
NiBP: RESIDUAL
PRESSURE
Notification
area
Same as RESID PRESS.
See RESID PRESS for details.
NO PROBE
SPO2 VS box
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
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
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 reposition or re-apply as necessary
• Try a different limb or site.
OVERSCALE
ECG trace
area
The ECG waveform is too
large and the peaks are being
clipped.
NiBP has exceeded the
allowed pressure for the
patient type.
Reduce the waveform size by choosing
a setting in the ECG Scale menu.
NOTE
No alarm
sound
generated
OVR PRESS
9‐20 Alarms
NiBP VS box
• 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.
Expression MR200 Instructions for Use
Displayed Message/
Indication
Message
Location
PERFORMING CO2
ZERO
Notification
area
PRESS CORR
PROBE OFF
Type
Probable Cause
Recommended Action
Displayed while performing
CO2 zeroing.
No action necessary. Allow the process
to complete.
NiBP VS box
An NiBP pressure correction
error has been detected.
SPO2 VS box
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).
• Check the alignment of the clip (or
grip).
• Try a different limb or site.
NOTE
• Ensure that the patient is
immobilized and not applying
pressure to the cuff.
• Check the cuff condition and
placement on the patient.
Alarm sounds
only if
reported after
a valid
numeric is
displayed.
PULSE?
SPO2 VS box
The clip (or grip) may not be
applied optimally; or, the
tissue at the application site
may be too opaque.
RESID PRESS
NiBP VS box
Residual pressure remains in
the NiBP system.
Disconnect the NiBP hose and restart
the procedure.
REAL TONES
DISABLED
Notification
area
Displayed when in the
SOUND ADJUST >
ALARMS menu
Exit the menu.
The SPO2 attachment was
just applied to the patient or
it has shifted position since
attachment.
NOTE
No alarm
sound
generated
SEARCHING
SPO2 VS box
NOTE
Alarm sounds
only if
reported after
a valid
numeric is
displayed.
Expression MR200 Instructions for Use
• 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.
Alarms 9‐21
Displayed Message/
Indication
Message
Location
SIMULATION
System message
area
Type
Probable Cause
Recommended Action
Simulation mode is running.
Cycle power off and on.
Power was turned on, or the
Silence key was pressed.
Wait until the 120-second countdown
completes or press the Silence key.
The Suspend key was
pressed and alarms are now
suspended.
Press the Suspend key to exit the
mode.
NOTE
No alarm sound
generated
SOUND ON HOLD
System message
area
NOTE
No alarm sound
generated
SUSPENDED
System message
area
NOTE
No alarm sound
generated
WARNING
Move monitor away
from magnet. NiBP
and CO2 (if installed)
have been shut down.
Dialog box
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
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.
WRONG PRB
SPO2 VS box
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
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 message persists, contact technical
support.
If the indication persists, contact
technical support.
9‐22 Alarms
Expression MR200 Instructions for Use
Displayed Message/
Indication
Message
Location
Communication
and power
status display
area
Type
Probable Cause
Recommended Action
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
Communication
and power
status display
area
Low cart battery
Connect the cart to external power and
allow the batteries to charge.
Low module battery
Install a charged battery into the
module.
Physiological Alarm Indications and Messages
The following table contains an alphabetical listing of physiological alarm indications and
messages.
Displayed Message/
Indication
Message
Location
Type Probable Cause
Recommended Action
Red flashing VS numeric, and VS box of
waveform (if applicable)
associated
parameter
Alarm limit violation
VS box of
associated
parameter
Parameter data once present If an alarm was generated:
is no longer available or a
• Ensure that the wireless modules are
hardware failure has occurred.
still communicating; see page 2-16
for status indications.
If occurring in the NiBP VS
box, may indicate the
• Ensure that all patient attachments
measurement is out of range.
are still connected.
• A parameter’s hardware may have
experienced a problem; contact
technical support.
• Perform patient readings to confirm
physiological condition.
---
NOTE
Alarm sounds
only if reported
after a valid
numeric is
displayed.
Check the patient.
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.
Expression MR200 Instructions for Use
Alarms 9‐23
Displayed Message/
Indication
Message
Location
OVR
ECG or SPO2
VS box
Type Probable Cause
(Replaces the
numeric,
except for
ECG, which
will alternate
with a numeric
value that is
more than the
highest
specified heart
rate.)
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.)
9‐24 Alarms
Recommended Action
The heart rate measurement
was greater than the upper
measurement range of the
parameter
Check the patient.
The heart rate measurement
was less than the lower
measurement range of the
parameter
Check the patient.
If the indication persists, contact
technical support.
If the indication persists, contact
technical support.
Expression MR200 Instructions for Use
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.
10 9 8 7
Expression MR200 Instructions for Use
Trend Data and Printing 10‐1
Definition
Is the name of the dialog
Are the CO2-derived respiration readings
Are the CO2 readings
Are the SPO2 readings
Are the heart rate readings
Is the page number, displayed oldest (first) to newest (last)
Are the NiBP mean readings
Are the NiBP systolic/diastolic readings
Is the time of the reading
10
Is the date of the reading
Viewing Multi-Parameter Tabular Trend Data
To view tabular trend data for multiple parameters
Step
Action
Press the TRENDS key
(while in the normal mode).
The HISTORY menu appears and the first page of trend data are
displayed.
Turn 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.
To view other pages, repeat step 2.
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.
10‐2 Trend Data and Printing
Expression MR200 Instructions for Use
1
Definition
Is the name of the graph
Are the numeric values of the selected parameters (y-axes) and
plotted in the same color
Are the selected parameters (y-axis labels)
Is the y-axis plot
Is the plot grid
Is the x-axis plot
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
Expression MR200 Instructions for Use
Trend Data and Printing 10‐3
Viewing Multi Trend Graphical Data
To view graphical trend data for multiple parameters
Step
Action
Press the TRENDS key
(while in the normal mode).
The HISTORY menu appears and the first page of trend data are
displayed.
Turn the control knob to MULTI TRENDS and then press the knob.
The MULTI TRENDS submenu appears.
Turn the control knob to SELECT and then press the knob to choose
the parameters used in the plot.
Turn 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.
If 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.
Turn the control knob to TIME BASE and then press the knob to set
the time base used for the plot.
Turn 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.
10‐4 Trend Data and Printing
Turn the control knob to MENU BACK and then press the knob to
position the menu behind the graph for unobstructed viewing.
Turn 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
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
Press the TRENDS key
(while in the normal mode).
The HISTORY menu appears. Current settings are displayed.
Turn 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.
Turn the knob to the desired setting or item and then press the
knob.
If MULTI TRENDS was selected, go to step 5; otherwise, go to step
7.
Turn 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.
Expression MR200 Instructions for Use
Turn the knob to the desired setting or item and then press the
knob.
Trend Data and Printing 10‐5
Step
Action
Press the Main key
to close the menu.
Alternative: Turn the knob to RETURN and then press the knob, or
wait approximately 60 seconds.
PREV PAGE
Displays the previous page of the history file.
To display the previous page of the history file
See Viewing Multi‐Parameter Tabular Trend Data on page 10‐2 for details.
NEXT PAGE
Displays the next page of the history file.
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.
10‐6 Trend Data and Printing
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
Trend Data and Printing 10‐7
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.)
Indication
Meaning
Rising
Declining
Stable
None declared
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.
10‐8 Trend Data and Printing
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
Trend Data and Printing 10‐9
.
Setup key
PRINTER
menu
Control knob
To change settings in the PRINTER menu
Step
Action
Press the SETUP key
The SETUP menu appears.
Turn the control knob to PRINTER SETUP and then press the knob.
The PRINTER menu appears. Current settings are displayed.
Turn 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.
Turn the knob to the desired setting and then press the knob.
To change other options, repeat steps 3 and 4.
Press the Main key
to close the menu.
Alternative: Turn the knob to RETURN and then press the knob, or
wait approximately 60 seconds.
10‐10 Trend Data and Printing
Expression MR200 Instructions for Use
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.
11
10
Definition
Trace 1 parameter
Date and time (formatted as MM/DD/YY-HH:MM:SS)
Patient type
Trace delay
Trace speed
Parameter information
Values of active parameters at time of printing
Trace 2 parameter information
Trace 2 parameter
10
Trace 2 waveform
11
Trace 1 waveform
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.
Expression MR200 Instructions for Use
Trend Data and Printing 10‐11
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)
•
•
•
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.
10‐12 Trend Data and Printing
Expression MR200 Instructions for Use
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
Expression MR200 Instructions for Use
Cleaning and Maintenance 11‐1
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.
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
*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.
11‐2 Cleaning and Maintenance
Expression MR200 Instructions for Use
CAUTIONS
• Other than those specified in the preceding table, avoid ammonia-, phenol- and acetonebased 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
Turn off the cart and unplug the AC power cord. Remove the
batteries, if installed.
Remove the battery from each wireless module.
Remove all visible debris from the cart and wireless modules using
soap and water.
CAUTIONS
Never pour liquid onto the equipment.
Clean 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.
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.
Expression MR200 Instructions for Use
Cleaning and Maintenance 11‐3
Step
Action
Allow the cart and the modules to dry. (No rinsing is required.)
Check 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.
Check the cart and modules for damage and contact technical
support if damage is found.
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.
11‐4 Cleaning and Maintenance
Expression MR200 Instructions for Use
To clean a reusable accessory
Step
Action
Remove the accessory from use.
Remove all visible debris from the accessory using soap and water.
CAUTION
Never pour liquid onto the accessory.
Clean 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.
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.
Allow the accessory to dry. (No rinsing is required.)
Check the accessory for any residual debris. If any debris is present,
repeat steps 2 through 5 then re‐examine the sensor before
proceeding.
Check the accessory for damage and discard the accessory if
damage is found; see page 11‐6 for details.
Store the accessory; see page 11‐6 for details.
Inspect the accessory for any cracks, holes, tears, cuts, etc. that
could affect operation and replace as necessary.
Sterilizing the Accessories
The accessories are not sterilizable. Severe damage, not covered by the warranty, will result.
Expression MR200 Instructions for Use
Cleaning and Maintenance 11‐5
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.
11‐6 Cleaning and Maintenance
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
Cleaning and Maintenance 11‐7
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.
11‐8 Cleaning and Maintenance
Expression MR200 Instructions for Use
To test the NiBP system for leakage
Step
Action
Attach a normal adult cuff and interconnect hose, or a test volume
to the MR200.
Press the PATIENT key
The PATIENT menu appears.
Turn the control knob to ADULT (or PEDIATRIC) and then press the
knob.
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Turn the control knob to SERVICE(BIO‐MED) and press the knob.
The SERVICE(BIO‐MED) menu appears.
Turn the control knob to NiBP TESTS and press the knob.
The NiBP TESTS menu appears.
Turn the control knob to LEAK TEST and then press the knob.
The NiBP LEAK TEST dialog box appears.
Expression MR200 Instructions for Use
Turn 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.
Cleaning and Maintenance 11‐9
Default Initialization
The settings for the MR200 can be restored to factory default values.
Step
Action
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Turn the control knob to DEFAULT SETUPS and press the knob.
Scroll to FACTORY and press the knob.
All current settings will be lost.
Turn off the MR200.
Turn on the MR200.
The monitor’s settings are returned to the 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
11‐10 Cleaning and Maintenance
Action
Connect AC power to the cart and insert at least one fully charged
battery.
Turn on the cart then wait until the normal mode is displayed; see
LCD on page 2‐13.
Expression MR200 Instructions for Use
Step
Action
Insert the USB program update device that contains the desired
software into the USB port.
USB port
USB program
update device
The WPU Program Update window appears.
Current software revisions are displayed, where any needed update
will be denoted by an asterisk.
Turn 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.
Turn off the cart and remove the USB program update device from
the USB port.
Press and hold the control knob while turning on power to the cart.
Observe 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
When the cold start banner is momentarily displayed, release the
Main key
The MR200 will boot to the normal mode.
10
Expression MR200 Instructions for Use
If the cold start banner was not displayed, repeat steps 7–9.
Cleaning and Maintenance 11‐11
Step
11
Action
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.
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.
11‐12 Cleaning and Maintenance
Expression MR200 Instructions for Use
To enter the SERVICE(BIO‐MED) menu
Step
Action
Press the SETUP key
The SETUP menu appears.
Turn the control knob to MONITOR SETUP and then press the knob.
The MONITOR menu appears. Current settings are displayed.
Turn the control knob to SERVICE(BIO‐MED) and then press the
knob.
The SERVICE(BIO‐MED) menu appears. Current settings are
displayed.
Turn 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.
Press the Main key
to close the menu.
Alternative: Turn the knob to RETURN and then press the knob.
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
Expression MR200 Instructions for Use
Cleaning and Maintenance 11‐13
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:
11‐14 Cleaning and Maintenance
Expression MR200 Instructions for Use
•
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.)
Expression MR200 Instructions for Use
Cleaning and Maintenance 11‐15
•
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.
11‐16 Cleaning and Maintenance
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
Cleaning and Maintenance 11‐17
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
11‐18 Cleaning and Maintenance
Action
In a location outside of the MR magnet room, ensure that power is
disconnected and that both batteries are removed from the cart.
Cover the LCD. Install foam A over the upper portion of the cart.
Expression MR200 Instructions for Use
Step
Expression MR200 Instructions for Use
Action
With the crate oriented as shown, place it into an upright position.
Roll the cart into the crate.
Carefully lower the crate. Slide foam B into foam C then insert it
between the base of the cart and the crate.
Insert foam D into foam A, and insert foam E between foam C and
the crate.
Cleaning and Maintenance 11‐19
Step
11‐20 Cleaning and Maintenance
Action
Place the lid on the crate.
Install all the clips into the lid on the crate, ensuring that each is
locked.
Expression MR200 Instructions for Use
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
Expression MR200 Instructions for Use
Specifications A‐1
Additionally, this equipment complies to the following national or regional industry standards for safety and
performance:
•
1999/5/EC, Radio & Telecommunications Terminal 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
A‐2 Specifications
Expression MR200 Instructions for Use
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).
Expression MR200 Instructions for Use
Specifications A‐3
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
A‐4 Specifications
Expression MR200 Instructions for Use
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
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
B2 ‐ Vent Tachycardia
2 mVpp, 195 BPM
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.
Expression MR200 Instructions for Use
Specifications A‐5
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.
A‐6 Specifications
Expression MR200 Instructions for Use
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
Expression MR200 Instructions for Use
Specifications A‐7
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
A‐8 Specifications
Expression MR200 Instructions for Use
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)
Compensations
(Automatic CO2 ambient pressure
compensation 400 to 800 mmHg)
Expression MR200 Instructions for Use
800 ms
440 ms
Compensations for expired O2 Balance gas (N2, N2O, O, He) and
Anesthetic AgentsB
Uses gas compensation information to correct the raw carbon
dioxide value
Specifications A‐9
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
A.
GAS or Vapor
Halothane
Enflurane
Isoflurane
Desflurane
0.74
1.68
2.00
6.30
MAC Level % (v/v)
(From Olivier C. Wenker: Review of Currently Used Inhalation Anesthetics: Part I. The Internet Journal of Anesthesiology, 1999, Volume
3 Number.)
B.
Measured
Gas
Carbon
Dioxide
Quantitative Effects of Gas or Vapor
N20
HAL
ENF
ISO
SEVO
Xenon
Helium
DES
Ethanol
Isopropanol
Acetone
Methane
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
A‐10 Specifications
Expression MR200 Instructions for Use
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
Wiring view
Pin Designator
Signal Name
Description and Characteristics
DIGITAL GATING PULSE
ECG/SPO2 digital gating pulse
• Peak to peak voltage: 3.3 V to 5.0 V
• Pulse duration: 10 ± 3 ms
SIGNAL GROUND
Return voltage reference for all other signal pins
RESP ANALOG
Analog respiration gating waveform signal
• Maximum output voltage: ± 5 V
• Maximum current: 5 mA
• Peak‐to‐peak signal voltage: 1 V
ECG 1V ANALOG
Analog ECG 1‐Volt waveform signal
• Output signal scaling: 1 V/mV
• Maximum output voltage: ± 5 V
• Maximum current: 5 mA
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)
SPO2 40mV ANALOG
SPO2 IR/red analog gating waveform signal
• Signal scaling: 1 V/mV
• Maximum output voltage: 40 mV
ECG 1mV ANALOG
ECG analog gating waveform signal
• Signal scaling: 1 mV/mV
• Maximum current: 5 mA
• Maximum output voltage: 20 mV
E, K, L, M, N, O
SPO2 2V ANALOG
SPO2 IR/red analog gating waveform signal, maximum output
voltage: 2 V
UNUSED
Unused pins
Expression MR200 Instructions for Use
Specifications A‐11
A‐12 Specifications
Expression MR200 Instructions for Use
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
Expression MR200 Instructions for Use
Warranty B‐1
B‐2 Warranty
Expression MR200 Instructions for Use
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
Expression MR200 Instructions for Use
Regulatory Information C‐1
C‐2 Regulatory Information
Expression MR200 Instructions for Use
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:
Expression MR200 Instructions for Use
Guidelines and References D‐1
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).
D‐2 Guidelines and References
Expression MR200 Instructions for Use
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
Bashein G, Syrory G. Burns associated with pulse oximetry during magnetic resonance imaging.
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
1993;72:166‐7.
Chou C‐K, McDougall JA, Chan KW. Absence of radiofrequency heating from auditory implants
during magnetic resonance imaging. Bioelectromagnetics 1997;44:367‐372.
Dempsey MF, Condon B. Thermal injuries associated with MRI. Clin Radiol 2001;56:457‐65.
Dempsey MF, Condon B, Hadley DM. Investigation of the factors responsible for burns during
MRI. J Magn Reson Imaging 2001;13:627‐631.
ECRI, Health Devices Alert. A new MRI complication? Health Devices Alert. May 27, pp. 1, 1988.
ECRI. Thermal injuries and patient monitoring during MRI studies. Health Devices Alert. 1991;20:
362‐363.
Expression MR200 Instructions for Use
Guidelines and References D‐3
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
electrodes: In vitro study. Am J Neuroradiol 2002;23:1795‐1802.
Heinz W, Frohlich E, Stork T. Burns following magnetic resonance tomography study. (German) Z
Gastroenterol 1999;37:31‐2.
http://www.MRIsafety.com
International Electrotechnical Commission (IEC), Medical Electrical Equipment, Particular
requirements for the safety of magnetic resonance equipment for medical diagnosis,
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
Categorical Course in Diagnostic Radiology: Practical MR Safety Considerations for Physicians,
Physicists, and Technologists, Syllabus, 87th Scientific of the Radiological Society of North
America, Chicago, pp 111‐123, 2001.
Shellock FG. Magnetic Resonance Procedures: Health Effects and Safety. CRC Press, LLC, Boca
Raton, FL, 2001.
D‐4 Guidelines and References
Expression MR200 Instructions for Use
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.
Expression MR200 Instructions for Use
Guidelines and References D‐5
D‐6 Guidelines and References
Expression MR200 Instructions for Use
Notes
Notes
Notes
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