Invivo ESSENTIAL MRI PATIENT MONITOR User Manual 989803173791

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Essential MRI Patient Monitor
(Model 865353)
Instructions for Use
989803173791 Rev 0.6
English
*989803173791*
989803173791
2
989803173791 Rev 0.6
Manufacturer
Invivo Corporation
Orlando, Florida 32826
U.S.A.
(407) 275‐3220
(800) 331‐3220
www.invivocorp.com
Copyright
Copyright © 2010, Invivo. All rights reserved. Printed in the United States.
REF 989803173791 Rev. A, October 2010
Equipment Classification
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:
IPX2 (enclosed equipment tilted 15 degrees
with protection against dripping liquid).
According to the methods of sterilization
or disinfection:
Non‐sterilizable. Use of liquid surface
disinfectants only.
According to the mode of operation:
Continuous operation
Equipment not suitable for use in the presence of flammable anesthetic mixture with air
or with oxygen or nitrous oxide.
NOTE
Laws in the United States restrict this device to sale by or on the order of a physician.
989803173791 Rev 0.6
Proprietary Information
This document and the information contained in it is proprietary and confidential information of
Invivo and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to
others, or disseminated without the prior written permission of Invivo. This document is
intended to be used by customers and is licensed to them as part of their Invivo equipment
purchase. Use of this document by unauthorized persons is strictly prohibited.
Invivo 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.
Invivo has taken care to ensure the accuracy of this document. However, Invivo 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. Invivo 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.
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.
989803173791 Rev 0.6
Contents
Chapter 1: Important Information
Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
System Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Document Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Electromagnetic Compatibility (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Radios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
EMC Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
EMC Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Battery Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Disposing of Batteries in Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Disposing of Batteries in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
List of Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Unpacking the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Examining the Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Carry Case. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mount Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Roll Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14
14
14
15
16
Chapter 2: Getting Started
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Using Batteries Safely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Main Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Module Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Charging Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18
18
20
21
Monitor Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Wireless SpO2 Module Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Assigning the Module Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Changing the Module Network Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Initial System Power-Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Display Panel Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Chapter 3: Preparation for Use
Using the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
System Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
989803173791 Rev 0.6 Contents i
Navigating the Menu Groups and Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Controlling Menu Changes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Locking and Unlocking the Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Patient Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Setup Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Service Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Network Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Alarm Limits Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Sound Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Chapter 4: Monitoring SpO2
SpO2 Sensor and Wireless SpO2 Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Connecting the Sensor and Attachments to the WSpO2 Module . . . . . . . . . . . . . . . . . . . . . . . 52
Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Applying and Positioning the SpO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Positioning the WSpO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Measuring SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Waveform and Vital Sign Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
No Data Available Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Assessing Suspicious SpO2 Readings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Perfusion Index Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Managing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Alarm Types, Priorities and Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Physiological Alarm Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Technical Alarm Violations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Alarm Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
System Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Chapter 5: Workflow
Workflow Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Chapter 6: Maintenance and Repair
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Cleaning the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Cleaning the Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Appendix A: Specifications
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Dimensions and Weights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Display (LCD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Displayed Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
ii Contents 989803173791 Rev 0.6
Pulse Oximeter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Power Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Appendix B: Warranty
Warranty Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Appendix C: Regulatory Information
European Union . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Authorized Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Appendix D: Guidelines and References
Guidelines for the Prevention of Excessive Heating And Burns Associated with Magnetic Resonance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Notes
989803173791 Rev 0.6 Contents iii
iv Contents 989803173791 Rev 0.6
Chapter 1: Important Information
Information regarding the safety, accessories, installation, and operation of a fully equipped
Essential MRI Patient Monitor (Model 865353) is included in this manual. 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 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 Invivo. 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 Invivo or Invivo‐authorized service
personnel.
Intended Audience
The Essential MRI Patient Monitor (Model 865353) is intended for use by healthcare
professionals trained in the use of the equipment and vital signs monitoring.
Warnings
Before using the Essential MRI Patient Monitor (Model 865353), read the warnings here and
those in the Safety section below. The warnings and notes below refer to the Essential MRI
Patient Monitor (Model 865353) in its entirety.
WARNINGS
• Thoroughly read and understand these Instructions for Use prior to use.
•
Shock hazard exists if the system is operated without covers.
•
Use only supplied power cords and connect only to properly grounded AC outlets to
avoid electrical shock.
989803173791 Rev 0.6 Chapter 1: Important Information 1
WARNINGS
• Patient motion or position of the accessories may affect measurement accuracy. Always
consult a physician for interpretation of measurements provided by the system.
•
Perform operational verification prior to use. If the system fails to function properly,
remove it from use and contact Invivo 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 Invivo accessory (if
applied directly over the conductor), thus increasing the risk of heating.
NOTE
The Essential MRI Patient Monitor (Model 865353) is not intended for use on a patient being
transported outside a healthcare facility.
Conventions
The Essential MRI Patient Monitor (Model 865353) uses certain conventions throughout the
interface to make it easy for you to learn and use. This accompanying user information also uses
document conventions to assist you in finding and understanding information.
System Conventions
These conventions are used in the system:
•
Operational control is accomplished through the display panel.
•
When control or menu items are provided on the display panel, touching that control or
item will activate or open it.
•
To protect against accidental changes of irreplaceable data, a confirm/cancel prompt is
associated with certain menu options. When a prompt is displayed, you must confirm or
cancel this action; otherwise, a delay of approximately 30 seconds without selection will be
equivalent to selecting cancel.
Document Conventions
•
All procedures are numbered, while any sub‐procedures are lettered. Complete the steps
in the sequence presented to ensure success. Procedures are indicated by the following
table:
2 Chapter 1: Important Information 989803173791 Rev 0.6
Step
Action
•
Bulleted lists indicate general information about a particular function or procedure, and do
not imply a sequential procedure.
•
Messages regarding a condition in the device are given within quotation marks (“”) spelled
and punctuated as they appear in the system, unless included as information in a table.
•
Control names, buttons and menu items or titles are spelled and punctuated as they
appear in the system.
•
Symbols appear as they appear on the system.
•
Select means to touch or tap lightly with a finger (or stylus) within the boundaries of a
control item on the display panel.
•
The left side of the system is on your left as you stand in front of the system, facing it. The
front of the system 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 regarding system usage.
989803173791 Rev 0.6 Chapter 1: Important Information 3
Accessories
Available accessories are listed in the tables below. Only use recommended Invivo patient
sensors, grips, etc, as other brands may compromise the safety and accuracy of the system.
SpO 2
Description
Part Number
Quick Connect SpO2 Clip, Adult
989803166531
Quick Connect SpO2 Clip, Pediatric
989803166541
Quick Connect SpO2 Grip, Adult, 20/box
989803166551
Quick Connect SpO2 Grip, Infant, 20/box
989803166571
Quick Connect SpO2 Grip, Neonatal, 20/box
989803166581
Quick Connect SpO2 Grip, Pediatric, 20/box
989803166561
Quick Connect SpO2 Grip, Starter Pack
989803167111
Quick Connect SpO2 Sensor, MRI
989803161991
Wireless SpO2 Module (Expression)
989803163111
Wireless SpO2 Module (Precess ‐ Blue version)
989803172431
Power
Description
Part Number
Main Battery
989803171671
Module Battery
9065
Power Adapter
989803171691
Power Cord, Brazil 250V
989803173901
Power Cord, European 220‐230V
453564177501
Power Cord, United Kingdom 220‐240V
989803174171
Power Cord, US 110V
989803168211
Power Cord, Universal 220V
4 Chapter 1: Important Information 989803173791 Rev 0.6
AS18A
Miscellaneous
Description
Part Number
Carry Case
989803171711
Mount Adapter
989803171681
Roll Stand
989803173761
Universal Holder Pole Kit (for use with Roll Stand)
989803174281
Information for Use Manual, Chinese, Simplified
989803174041
Information for Use Manual, Chinese, Traditional
989803174081
Information for Use Manual, Czech
989803173911
Information for Use Manual, Dutch
989803173921
Information for Use Manual, English
989803173791
Information for Use Manual, Finnish
989803173931
Information for Use Manual, French
989803173941
Information for Use Manual, German
989803173951
Information for Use Manual, Greek
989803173961
Information for Use Manual, Hungarian
989803173971
Information for Use Manual, Italian
989803173981
Information for Use Manual, Japanese
989803173991
Information for Use Manual, Norwegian
989803174001
Information for Use Manual, Polish
989803174011
Information for Use Manual, Portuguese
989803174021
Information for Use Manual, Russian
989803174031
Information for Use Manual, Slovak
989803174051
Information for Use Manual, Spanish
989803174061
Information for Use Manual, Swedish
989803174071
Information for Use Manual, Turkish
989803174091
Service Manual
989803173771
989803173791 Rev 0.6 Chapter 1: Important Information 5
Safety
Electromagnetic Compatibility (EMC)
The system is intended for use in the electromagnetic environment specified below. Given the
system’s electromagnetic emissions and immunity characteristics, the customer or the user
should assure that the system is used within such an environment.
Radios
Frequency Range: 2402 to 2482 MHz.
Modulation Type: GMSK.
Monitor EIRP: 4.2 dBm (peak).
WSpO2 EIRP: 0 dBm (peak)
EMC WARNINGS
• Operation of the system outside the specifications indicated in Appendix A may 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 and components other than those specified in the Accessories list
accompanying these instructions for use (with the exception of items sold by Invivo 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 system should not be used adjacent to or stacked with other equipment (except
other Invivo equipment, as detailed in this document) and that if adjacent or stacked use
is necessary, the equipment or system must be observed to verify normal operation in
the configuration in which it will be used.
•
The system needs to be installed and put into service according to the EMC information
provided below. Portable and mobile RF communications equipment can affect medical
electrical equipment. The system may be interfered with by other equipment with CISPR
emission requirements.
6 Chapter 1: Important Information 989803173791 Rev 0.6
EMC Emissions
Electromagnetic emissions is the ability of a product, a device, or a system to introduce
intolerable electromagnetic disturbances into the use environment.
Guidance and Manufacturer’s Declaration –
Electromagnetic Emissions
Emissions Test
Compliance
Electromagnetic Environment ‐ Guidance
The Essential MRI Patient Monitor (Model 865353) is intended for use in the electromagnetic environment
specified below. The customer or the user of the Essential MRI Patient Monitor (Model 865353) should assure
that it is used in such an environment.
RF Emissions
CISPR 11
Group 1
RF Emissions
CISPR 11
Class A
Harmonic Emissions
IEC 61000‐3‐2
Class A
Voltage Fluctuations/flicker
emissions
IEC 61000‐3‐3
Complies
The system uses RF energy only for its internal functions.
Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
The system is suitable for use in all establishments, other
than domestic establishments and those directly
connected to the public low‐voltage power supply
network that supplies buildings used for domestic
purposes.
989803173791 Rev 0.6 Chapter 1: Important Information 7
EMC Immunity
Electromagnetic immunity is the ability of a product, a device, or a system to function
satisfactorily in the presence of electromagnetic interference.
Guidance and Manufacturer’s Declaration ‐ Electromagnetic Immunity
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment ‐ Guidance
The Essential MRI Patient Monitor (Model 865353) is intended for use in the electromagnetic environment
specified below. The customer or the user of the Essential MRI Patient Monitor (Model 865353) should assure
that it is used in such an environment.
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
Portable and mobile RF communications
equipment should not be used closer to any part
of the system (including cabling) than the
recommended separation distance, as calculated
by the equation applicable to the frequency of
the transmitter. Recommended separation
distance:
d = (3.5/V1)
d = (3.5/E1) P
(80 MHz to 800 MHz)
d = (7/E1) P
(800 MHz to 2.5 GHz)
Where P is the maximum transmitter output
power rating in watts (W), according to its manu‐
facturer, 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 this
symbol:
NOTES
• At 80 MHz and 800 MHz, the higher frequency range applies.
•
These guidelines may not apply in all situations, as electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio, and TV broadcasts 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 system location exceeds the applicable RF
compliance level above, the system should be observed to verify normal operation. If abnormal operation is
observed, additional measures may be necessary, such as reorienting or relocating the system.
b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
8 Chapter 1: Important Information 989803173791 Rev 0.6
Recommended Separation Distances
The system is intended for use in an electromagnetic environment where radiated RF
disturbances are controlled. The customer or user of the system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the system as recommended below, according
to the maximum output power of the communications equipment.
Recommended Separation Distances between Portable and Mobile RF Communications Equipment
and the System
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)
The Essential MRI Patient Monitor (Model 865353) is intended for use in the electromagnetic environment
specified below. The customer or the user of the Essential MRI Patient Monitor (Model 865353) should assure
that it is used in such an environment.
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 minimum 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 its manufacturer.
NOTES
• At 80 MHz and 800 MHz, the higher frequency range applies.
•
These guidelines may not apply in all situations, as electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
989803173791 Rev 0.6 Chapter 1: Important Information 9
Battery Disposal
The system uses lithium batteries that are subject to strict disposal regulations for user and
environmental safety.
Caution
CAUTIONS
•
Store batteries in a dry place, between 0°C to 40°C.
•
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 the battery. The batteries contain hazardous material that must be
recycled or disposed of properly. (Refer to the disposal guidelines below.)
Disposing of Batteries in Europe
The European Community (EC) has issued two directives regarding battery disposal: 91/157/EEC
and 93/86/EEC. Each member country implements these independently. Thus, in each country
the manufacturers, importers, and users are responsible for the proper disposal or recycling of
batteries. Confirm proper disposal requirements with your healthcare facility or distributor.
Disposing of Batteries in the United States
Lithium batteries are neither specifically listed nor exempted from the Federal Environmental
Protection Agency (EPA) hazardous waste regulations, as conveyed by the Resources
Conservation and Recovery Act (RCRA). The only metal of possible concern in the battery is the
lithium metal, which is not listed or characterized as a toxic hazardous waste. A significant
amount of spent cells and batteries that are untreated and not fully discharged are considered as
reactive hazardous waste. Thus, hazardous waste of spent cells and batteries can be disposed
after they are first neutralized through an approved secondary treatment prior to disposal (as
required by U.S. Land Ban Restriction of the Hazardous and Solid Waste Amendments of 1984).
Disposal of spent batteries must be performed by an authorized, professional disposal company,
which has the knowledge in the requirements of the Federal, the State and the Local authorities
regarding hazardous materials, transportation, and waste disposal. Confirm proper disposal
requirements with your healthcare facility, distributor, and/or local EPA office.
10 Chapter 1: Important Information 989803173791 Rev 0.6
List of Symbols
The following symbols are used on the system, packing materials, and in this document:
Attention, consult
accompanying documents
MR Conditional: Use in the
MR environment is restricted
to certain conditions of use to
ensure patient and operator
safety.
Non‐ionizing radiation
Not MR safe
Power on / off
Percent oxygen pulse
saturation
Product part number
Earth ground
Alternating current
Antenna
Direct current
Device conforms to the
Medical Device Directive
Product serial number
Warning Shock Hazard
Date of manufacture
Warning / Caution
YYYY‐MM
989803173791 Rev 0.6 Chapter 1: Important Information 11
Defibrillator‐Proof type CF
equipment (IEC 60601‐1)
protection against shock
Attention: Electrostatic safety
device, observe precautions
Potential restrictions for
equipment including radios
may apply within one or more
European (EU) member
states.
Dangerous voltage
Type CF applied part
Patient
Main battery gauge
Module battery gauge
No Battery Communications
No (Module) Communications
Energy Star rated product
Green Seal product
Do not adjust without
referring to service manual
Radio network (wireless
modules)
Network A
Network 1
Network B
Network 2
12 Chapter 1: Important Information 989803173791 Rev 0.6
Network C
Network 3
Network D
Network 4
Network E
Network 5
Device conforms to the
R&TTE Directive (Radio &
Telecommunications Terminal
Equipment)
Canadian Standards
Association (CSA) Safety Mark
for the United States and
Canada
Federal Communications
Commission
Dispose of the battery in
accordance with your
country’s requirements
Dispose of electrical
equipment in accordance
with your country’s
requirements
Indoor, dry location use only
Device conforms to the
Electrical Appliance and
Materials Law of Japan
External power supply
international efficiency mark,
level 4
Underwriters Laboratories
Recognized Component
Mark, compliance in Canada
and U.S.A.
989803173791 Rev 0.6 Chapter 1: Important Information 13
Unpacking the System
Remove the contents from the shipping container(s). Carefully examine all items for signs of
damage that may have occurred during shipment. Also, check all items against the packing list
and the purchase request.
To report shipping damage or to resolve any issues or concerns with your order, contact Invivo
Customer Service. (Save all packing materials and related shipping documents, as these will be
required to process a damage claim with the carrier.)
CAUTION
The Essential MRI Patient Monitor (Model 865353) must be used and stored according to the
environmental specifications in Appendix A. Failure to follow these specifications may affect
system accuracy.
Examining the Contents
The system includes these items:
•
Monitor and battery
•
Power adapter (not MR safe)
•
Power cord
•
IFU manual
•
Wireless SpO2 module, battery and accessories (optional)
Accessories
Optional accessories are available to protect, carry and mount the system.
CAUTION
When using the accessories make sure that the view of the display panel is not obstructed.
Carry Case
The carry case (REF 989803171711) offers convenient protected storage for the monitor, even
during operation. A large clear window allows visual and operational access to the display panel,
while side and rear pockets offer storage for modules and accessories.
14 Chapter 1: Important Information 989803173791 Rev 0.6
Caution
CAUTIONS
• Do not place magnetic items inside the carry case, as they could be inadvertently brought
into the MRI system room.
•
Ensure that the alarm tone is audible when operating the monitor using the carry case.
•
Use caution when operating the monitor using the carry case, as the alarm light will not be
visible.
Mount Adapter
The mount adapter (REF 989803171681) is a secure solution when attaching the monitor to a
pole or rail.
Pins
Thumbscrew
Clamp
Knob
989803173791 Rev 0.6 Chapter 1: Important Information 15
To install the monitor onto the mount adapter, follow the steps below:
Step
Action
Align the pins (Item 1) of the mount adapter to the locator holes in
the base of the monitor.
Insert the Thumbscrew (Item 2) into the base of the monitor then
tighten to secure the monitor to the mount.
With the monitor in the desired location, place the clamp (Item 3)
around a pole or rail then securely tighten the knob (Item 4).
If needed, pivot the mount horizontally or vertically to orient the
monitor for viewing.
If needed, loosen the knob (Item 4) slightly to readjust the monitor
for the optimum viewing angle then retighten the knob. This
completes the procedure.
Roll Stand
The roll stand (REF 989803173761) offers a wheeled mobility solution
when transporting the monitor (mount adapter option also required).
And, for convenient storage of the module and accessories, the Universal
Holder Pole Kit (REF 989803174281) is available.
16 Chapter 1: Important Information 989803173791 Rev 0.6
Chapter 2: Getting Started
The Essential MRI Patient Monitor (Model 865353) is intended for use by health care professionals
monitoring pulse oximetry and pulse rate in an MRI system room and in close proximity to the
scanner magnet. Additionally, this monitoring is provided before, during and after active scanning
in the MRI environment.
The system combines wireless communications, radio frequency shielding, digital signal
processing and adaptable mounting technologies to provide accurate, continuous and reliable
patient monitoring performance in the dynamic MRI environment.
The Essential MRI Patient Monitor (Model 865353) can be configured, accessed and adjusted for
the unique vital needs, conditions and situations of a wide spectrum of patients from neonate to
adult, specifically:
•
Critically ill patients
•
Intervention procedures
•
Intraoperative procedures
•
Patient transport within the MR environment
NOTE
The system is suitable for use in the presence of electrosurgery.
System Components
The components that comprise a working Essential MRI
Patient Monitor (Model 865353) system include the
monitor and a WSpO2 module with attachments.
CAUTION
To minimize the chance of image artifacts, none of the monitoring components should be placed
within the MRI Field of View.
989803173791 Rev 0.6 Chapter 2: Getting Started 17
Battery Operation
The Essential MRI Patient Monitor (Model 865353) operates from rechargeable batteries that
provide approximately 8 hours of continuous power. Visual indications of the charged capacity of
the batteries is constantly reported, while alarms provide alerts when low power conditions are
detected.
Using Batteries Safely
The batteries in this system are non‐magnetic and can be handled safely in the MR system room.
WARNING
Do not use or take the power adapter inside the MR system room. The device is magnetic and
will be pulled into the MR system. The device is intended for use with the main battery and the
module battery only when outside the MR system room.
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 a battery
that has an expired life cycle and replace it with a new Invivo specified battery; refer to Battery
Disposal in Chapter 1 when discarding a battery. To ensure the safety of operators and patients,
observe the following warnings and cautions.
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.
CAUTIONS
• If the battery contacts become dirty, wipe them clean with a dry cloth before use.
•
Keep metal objects away from the battery contacts.
Main Battery
The main battery fits the contour of the monitor and latches into the battery compartment.
CAUTION
Never force the battery into the battery compartment as damage to the battery and/or the
monitor could occur.
18 Chapter 2: Getting Started 989803173791 Rev 0.6
Installing the main battery
To install the main battery follow these steps:
Step
Action
Place the cover over the DC inlet on the main battery.
Cover
DC inlet
Lower the main battery into the battery compartment then pivot it
into place, as shown below.
Battery compartment
Slide the locking tab to the left until latched.
Locking tab
989803173791 Rev 0.6 Chapter 2: Getting Started 19
Removing the main battery
To remove the main battery follow these steps:
Step
Action
Slide the locking tab on the main battery to the right.
Main battery
Locking tab
Lift the main battery out of the battery compartment.
Battery compartment
Module Battery
The module battery latches into the wireless module.
Installing the module battery
To install the module battery, slide the battery in between the slots on the module until both
locking tabs latch.
Locking tab
Slot
Module battery
20 Chapter 2: Getting Started 989803173791 Rev 0.6
Removing the module battery
To remove the module battery, press both locking tabs and then slide the battery out of the
module.
Locking tab
Slot
Module battery
Charging Batteries
The intelligent charger, an integral part of the main battery assembly, simultaneously charges the
main and module batteries, while the external power adapter supplies the appropriate DC input.
NOTE
Before initial use, place the main battery on the charger for at least 5 seconds, as the battery is
shipped in a hibernating, partially charged, condition.
Module battery
Power adapter (AC cord not shown)
DC plug
DC inlet (with cover)
Main battery charge indicator
Power indicator
Module battery charge indicator
Main battery
Charging bay
989803173791 Rev 0.6 Chapter 2: Getting Started 21
WARNING
Do not use or take the power adapter inside the MR system room. The device is magnetic and
will be pulled into the MR system. The device is intended for use with the main battery and the
module battery only when outside the MR system room.
To charge batteries follow these steps:
Step
Action
Press the power switch for at least 1 second to turn off the
monitor.
Remove the main battery; see Removing the main battery, above.
Remove the module battery; see Removing the module battery,
above.
Insert the module battery into the charging bay on the main
battery. (The charging bay is keyed for proper battery insertion; do
not force the battery.)
Remove the cover from the DC inlet on the main battery.
Connect the AC cord to the AC inlet on the power adapter.
Connect the AC cord to an AC outlet located outside of the MR
system room.
22 Chapter 2: Getting Started 989803173791 Rev 0.6
8
Connect the power adapter to the DC inlet.
Observe the power (PWR) indicator and
verify that power is applied:
•
Green = DC power is connected.
•
None = No power is connected or an
error was detected. (Ensure that the
power adapter is properly connected
to the AC outlet.)
Allow both batteries to fully charge, as
indicated by the charge indicators:
•
Green = Charging complete
•
Yellow = Battery charging
•
None = No battery is installed or an
error was detected.
10
Disconnect the power adapter from the DC inlet.
11
Remove the module battery from the charging bay.
12
Insert the module battery into the module; see Installing the
module battery, above.
13
Insert the main battery into the monitor; see Installing the main
battery, above. This completes the procedure.
Monitor Overview
The monitor is an integrated device that houses communication, display, processing and power
technologies (including the transceivers and antennas). The monitor has the following user
features:
CAUTION
When using the monitor, ensure that your view of the display panel remains unobstructed.
989803173791 Rev 0.6 Chapter 2: Getting Started 23
2
Power switch
Handle
Speaker
Alarm light
Display panel
1. Power switch (
) ‐ Controls power to the monitor, where pressing the switch for more than
0.5 seconds turns power on, and pressing the switch for more than 1 second turns power off.
NOTE
If communications have not been detected for 15 minutes, the monitor will automatically turn off.
2. Handle ‐ Provides portability and houses the antennas.
3. Speaker ‐ Provides audible prompts and alarm indications, at a maximum volume of up to 85
dB; see Sound Menu in Chapter 3 for details.
4. Alarm light ‐ Provides a 360 degree visual alert for alarm conditions, glowing yellow or red,
depending upon the condition detected; see Managing Alarms in Chapter 4 for details.
5. Display panel ‐ Provides visual information and is the all‐touch interface for operation, control
and setup of the monitor.
Wireless SpO 2 Module Overview
The wireless pulse oximetry (WSpO2) module provides the patient’s readings, as detected signals
are converted then transmitted for processing and display. The module has the following user
features:
24 Chapter 2: Getting Started 989803173791 Rev 0.6
2
Network selection button
Sensor connector
Status indicator
Network icons
1. Network selection button ‐ Selects the network setting of the module.
2. Sensor connector ‐ Connects the module to the SpO2 Quick Connect sensor.
3. Status indicator ‐ Indicates the power and communication conditions of the module:
Status indicator
Color
State
None
Not
applicable
Green
Meaning
Power
Communication
The battery is not installed or it lacks
sufficient charge to power the module.
Not applicable
Flashing
Battery power good
Not communicating
Green
Solid
Battery power good
Good communications
Red
Flashing
Low battery condition
(less that 45 minutes remain)
Not communicating
Red
Solid
Low battery condition
(less that 45 minutes remain)
Good communications
4. Network icons ‐ Indicate the wireless network designated for module communications, where
the illuminated icon denotes the current network.
Assigning the Module Network
The module communicates through a bidirectional 2.4 GHz spread‐spectrum link, which is
automatically established upon monitor power‐up. The wireless network can be changed as
needed to comply with the requirements of your operating environment, but should always
989803173791 Rev 0.6 Chapter 2: Getting Started 25
match the setting assigned to the monitor; see Network Menu in Chapter 3 for monitor setup
details.
The wireless network for the module is indicated by its illuminated icon, while the currently
assigned network for the monitor is indicated by the network button on the display panel.
CAUTION
For system communications, the monitor and module must have the same network setting.
Changing the Module Network Setting
The wireless network for the module is changed via its network
selection button, located beneath the overlay, in the front upper
left corner of the device. (A slight bump can be felt when you pass a
finger over the button.)
When selecting a network for the module, place the module on a
flat steady surface, or hold it as shown in the illustration, and use
your thumb to press the network selection button.
Before starting the procedure, 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
•
Icon flashing
In the procedure below, the following illustrations are used to convey actions concerning
the use of the network selection button:
Press the
button
Release the
button
26 Chapter 2: Getting Started 989803173791 Rev 0.6
Press and hold
the button
Repeat as
desired
NOTE
Any part of the above sequence not completed will cause the module to revert to the network
previously set 30 seconds after the network selection button was last released.
To assign the wireless module to the monitor’s network follow these steps:
Step
Action
Identify the network setting of the monitor, as indicated by the
network button.
Network button
Remove the module battery from the module; see Module Battery,
above.
Install the module battery. The network icons will flash briefly and
then the current network icon will illuminate (for example,
Network C in the illustration below).
NOTE
Depending upon your module, the network icons may have letter or
numeric designators; and, though these examples show letter
designators, the process is the same for numeric designators.
989803173791 Rev 0.6 Chapter 2: Getting Started 27
Step
Action
Set the network of the module to the same network as the monitor
(see Step 1). 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 selection button
until the current network icon begins flashing rapidly. Then release
the network selection button.
NOTE
If the network change sequence is not started within 15 seconds
after the module has been turned on, a network change will not be
allowed. You must cycle module power and restart the sequence.
Changing the network, press the button again until the icon stops
flashing, then release the button. 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 flashing.) Repeat this sequence of pressing and releasing the
button until the icon of the network you prefer is rapidly flashing. If
you pass the desired network, simply continue pressing and
releasing the button until the desired network is flashing again.
28 Chapter 2: Getting Started 989803173791 Rev 0.6
Step
Action
When you reach the desired network, press and hold the button for
approximately 5 seconds to lock and save the new network. 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.
WARNING
If the message box, “WARNING! Multiple wireless modules
detected on network” is displayed, a module network setting
conflict has been detected by the monitor. Before proceeding, for
proper function, ensure that only one SpO2 module per network
has been assigned and is being used.
Initial System Power-Up
To apply power to the system follow these steps:
Step
Action
Ensure that the main battery is installed in the monitor; see Main
Battery, above.
Ensure that the module battery is installed the module; see Module
Battery, above.
989803173791 Rev 0.6 Chapter 2: Getting Started 29
Step
Action
Press the power switch for at least 0.5 seconds to turn on the
monitor.
The first time the monitor is turned on, set the display language for
the system:
NOTE
It can take up to 30 seconds until the boot‐up process has finished
and the monitor becomes ready.
•
In the Language menu, select a display language by touching
a corresponding Language button; see Navigating the Menu
Groups and Controls in Chapter 3 for details.
Language buttons
(If not set initially, the Language menu will continue to appear at
subsequent power‐ups until a display language is selected.)
30 Chapter 2: Getting Started 989803173791 Rev 0.6
Step
Action
Ensure sufficient monitor power by checking the main battery
indicators, where:
•
Gray gauge and time= Battery power OK, time remaining
field indicates approximate remaining charge in hours and
minutes.
•
Flashing yellow gauge and time = Low battery power (45
minutes or less power remaining).
•
No Battery Communications symbol
= No
communications between the monitor and the main battery.
Main battery indicators
989803173791 Rev 0.6 Chapter 2: Getting Started 31
Step
Action
Ensure sufficient module power and communications with the
monitor by checking the module battery indicators, where:
•
Blue gauge and time = Battery power OK (time remaining
field indicates approximate remaining charge in hours and
minutes) and good communications.
•
Flashing yellow battery gauge and time = Low battery power
(45 minutes or less power remaining).
•
No Comm symbol
= No communications between
the monitor and the module.
Module battery indicators
Verify proper operation of the SpO2 parameter; see Chapter 4.
32 Chapter 2: Getting Started 989803173791 Rev 0.6
Display Panel Overview
The display panel provides the following functions and information:
*****
10
11
12
13
14
15
23
22
21
20
19
SpO2 waveform
SpO2 message area
Speaker button
Alarms button
Informational message area
Demo Mode indicator
Patient category button
SpO2 parameter identifier (in percent)
18
17
16
SpO2 high alarm limit indicator
10
SpO2 vital sign numeric
11
SpO2 low alarm limit indicator
12
13
14
15
16
17
18
19
20
21
22
23
Heart rate (HR) parameter identifier (in beats per minute)
Heart rate high alarm limit indicator
Heart rate vital sign numeric
Heart rate low alarm limit indicator
Main Screen button
Setup button
Network button (dependent upon the network selection)
Main battery indicators
Module battery indicators
Alarms Pause button
Alarms Silence button
Perfusion index value
989803173791 Rev 0.6 Chapter 2: Getting Started 33
NOTE
Display update period is typically 1 second, up to a maximum of 30 seconds.
1. SpO2 waveform ‐ Provides the plethysmographic waveform, fixed across the screen and
updated with an erase bar, where a red waveform indicates an alarm condition; see Waveform
and Vital Sign Information in Chapter 4 for details.
2. SpO2 message area ‐ Displays SpO2 related messages. For a listing, see System Messages in
Chapter 4 for details.
3. Speaker button ‐ Sets the volume for alarm tone, touch and pulse tones; see Sound Menu in
Chapter 3 for details.
4. Alarms button ‐ Sets the high and low alarm limits for SpO2 and heart rate alarms; see Setup
Menu in Chapter 3 for details.
5. Informational message area ‐ Displays alarm messages when the Alarms Pause button or the
Alarms Silence button is selected. For a listing, see System Messages in Chapter 4 for details.
6. Demo Mode indicator ‐ Indicates that the monitor is operating in demonstration mode; see
Service Menu in Chapter 3 for details.
7. Patient category button ‐ Indicates and allows changes to the patient category; see Patient
Menu in Chapter 3 for details.
8. Parameter identifier ‐ Indicates the SpO2 parameter and unit of measurement.
9. SpO2 high alarm limit indicator ‐ Indicates and allows changes to the high limit setting for the
SpO2 alarm; see Alarm Limits Menu in Chapter 3 for details.
10. SpO2 vital sign numeric ‐ Indicates the SpO2 vital sign of the patient (given as a percentage)
and allows changes to the SpO2 alarm limits; see Waveform and Vital Sign Information in Chapter
4 for details.
NOTE
Normal response time of the numerics is approximately 10 seconds; however, in case of artifact or
poor signal conditions, the update period can be longer.
11. SpO2 low alarm limit indicator ‐ Indicates and allows changes to the low limit setting for the
SpO2 alarm; see Alarm Limits Menu in Chapter 3 for details.
12. Parameter identifier ‐ Indicates the heart rate parameter and unit of measurement.
13. Heart rate high alarm limit indicator ‐ Indicates and allows changes to the high limit setting
for the heart rate alarm; see Alarm Limits Menu in Chapter 3 for details.
34 Chapter 2: Getting Started 989803173791 Rev 0.6
14. Heart rate vital sign numeric ‐ Indicates the heart rate vital sign of the patient (given in beats
per minute) and allows changes to the heart rate alarm limits; see Waveform and Vital Sign
Information in Chapter 4 for details for details.
NOTE
Normal response time of the numerics is approximately 10 seconds; however, in case of artifact or
poor signal conditions, the update period can be longer.
15. Heart rate low alarm limit indicator ‐ Indicates and allows changes to the low limit setting for
the heart rate alarm; see Alarm Limits Menu in Chapter 3 for details.
16. Main Screen button ‐ Closes any open menus, returns the display to the normal operating
view, and can lock the screen; see Locking and Unlocking the Screen in Chapter 3 for details.
17. Setup button ‐ Opens the Setup menu; see Setup Menu in Chapter 3 for details.
18. Network button ‐ Opens the network setup menu; see Network Menu in Chapter 3 for
details.
19. Main battery indicators:
•
Displays the remaining main battery power as a gauge
and a time remaining
counter (formatted in hours:minutes). When less than forty‐five (45) minutes remain, the
time will flash in yellow and an alarm will be declared; see Managing Alarms in Chapter 4
for details.
•
Flashes the No Battery Communications symbol
if communications are not
established, or have been lost, between the monitor and the main battery.
20. Module battery indicators:
•
Displays the remaining module battery power as a gauge
and a time remaining
counter (formatted in hours:minutes). When less than forty‐five (45) minutes remain, the
time will flash in yellow and an alarm will be declared; see Managing Alarms in Chapter 4
for details.
•
Flashes the No Comm symbol
if communications are not established, or have been
lost, between the monitor and the module; also see No Data Available Indication in
Chapter 4 for details.
21. Alarms Pause button ‐ Allows you to temporarily deactivate alarm functions, where during
deactivation a 2 minute timer, flashing in red, will countdown in the informational message area;
see Managing Alarms in Chapter 4 for details.
22. Alarms Silence button ‐ Allows you to mute the alarm sound and turn off the alarm light
during an alarm (though indications will continue to appear in the informational message area,
and the alarming numeric will continue to flash). A new alarm will cause reactivation of alarm
functions. When selected, the “Alarms Silenced” message, flashing in red, will be displayed in the
informational message area; see Managing Alarms in Chapter 4 for details.
23. Perf ‐ Is the perfusion index, a numeric value for the portion of the measured signal caused
by arterial pulsation; see Waveform and Vital Sign Information in Chapter 4 for details.
989803173791 Rev 0.6 Chapter 2: Getting Started 35
36 Chapter 2: Getting Started 989803173791 Rev 0.6
Chapter 3: Preparation for Use
The Essential MRI Patient Monitor (Model 865353) provides the flexibility needed to perform
standard SpO2 monitoring, while allowing you to customize operations to fit your needs.
WARNING
Warning
Always verify proper communications between the module and monitor prior to patient use.
CAUTIONS
•
Avoid the use of cellular phones or other radio‐frequency transmitters in the proximity of
an operating system.
•
A minor but noticeable degradation in the wireless SpO2 radio communications will occur
in the presence of high‐powered radios.
Using the Monitor
Observe all warnings and cautions when using the Essential MRI Patient Monitor (Model
865353).
WARNING
Warning
Keep the Essential display out of the MR system bore and avoid contact with the patient’s bare
skin while the MRI scan is running. The device is electronic and susceptible to excessive heating
from the MRI scan RF only if placed inside the bore of the MR system during that scan. Failure
to do so may result in patient injury.
WARNING
Warning
Do not use or take the power adapter inside the MR system room. The device is magnetic and
will be pulled into the MR system. The device is intended for use with the main battery and the
module battery only when outside the MR system room.
989803173791 Rev 0.6 Chapter 3: Preparation for Use 37
System Parameters
The Essential MRI Patient Monitor (Model 865353) facilitates processing and display of the
plethysmographic waveform, and the associated numeric values and alarms for the oxygen
saturation of arterial blood and the derived heart rate. All patient information is provided on the
display panel.
Navigating the Menu Groups and Controls
The menu groups and controls for the Essential MRI Patient
Monitor (Model 865353) are accessed and navigated by
touching the active areas on the touch screen.
Touching an active button or indicator with your finger or a
passive object (such as a stylus) will cause the system to
produce a touch tone and open that menu or select that
option, setting or value. (Note that simultaneously touching
two or more areas of the screen may produce unpredictable
results.)
To guard against accidental changes, a locking feature allows
you to protect the monitor settings.
CAUTION
Never use sharp objects on the display panel or apply unnecessary pressure to the display panel,
as action can result in screen damage or failure.
Controlling Menu Changes
Depending upon the menu, these buttons control changes made to the options and settings:
NOTE
If a menu is open, delaying selection of an option for longer than 30 seconds closes the menu.
38
•
Confirm and Close button
: Touch to save changes and close the menu.
•
Close button
: Touch to discard changes that require confirmation and close the
menu. (Or touch another button.)
Chapter 3: Preparation for Use 989803173791 Rev 0.6
•
Main Screen button
: Touch to close an open menu (and save any changes ‐
except those that require confirmation) and return to the normal operating view.
Locking and Unlocking the Screen
The touch screen can be locked to protect against accidental changes to the setup or alarm
controls, while allowing monitoring functions to continue. When locked, the touch screen
functions will be inaccessible, as denoted by the “Screen Locked” message which will appear for
about 2.5 seconds after a button or indicator is touched. To restore operation to a locked screen,
press and hold the Unlock Screen button for about 3 seconds. Locking and unlocking methods are
described below.
NOTE
The Main Screen button is dynamic, changing to reflect the current state of the display where
“Main Screen” indicates an unlocked condition and “Unlock Screen” indicates a locked condition.
To lock the screen:
Touch the Main Screen button for about 3 seconds.
Main Screen button
To unlock the screen:
Touch the Unlock Screen button for about 3 seconds.
989803173791 Rev 0.6 Chapter 3: Preparation for Use 39
Unlock Screen button
Patient Menu
The Patient menu allows you to select the patient category.
Determining the appropriate patient category
Each safety agency recognizes that the patient category descriptions can be arbitrary and that
the following patient factors are more accurate in determining the appropriate method of
patient monitoring and treatment:
•
Weight
•
Body size
•
Limb circumference
•
Physiological development
•
Neurological development
•
Neuromuscular coordination
CAUTION
There may be occasions when a particular patient category is not suitable for its apparent
categorization based only on age. In these cases, a clinical decision shall be made to use another
patient category or measurement technique. The clinical decision shall be based on all of the
factors listed in Determining the appropriate patient category (above) to ensure the best possible
and most timely measurement acquisitions.
NOTES
40
•
The patient category button is dynamic, changing to reflect the current patient category.
•
Alarm limit default settings are applied whenever the patient category is changed, and
previously changed alarm settings for a certain patient category will be lost; see Alarm
Limits Menu (below) for details.
Chapter 3: Preparation for Use 989803173791 Rev 0.6
To enter the Patient menu:
Touch the Patient category button.
Patient category
button
Patient menu
The following options are available:
•
Adult: Allows you to set the monitoring functions for adult patients.
•
Pediatric: Allows you to set the monitoring functions for pediatric patients.
•
Neonatal: Allows you to set the monitoring functions for neonatal patients.
Setup Menu
The Setup menu options configure the alarm limits, adjust the brightness of the display panel and
access the service functions.
To enter the Setup menu:
Touch the Setup button.
Setup menu
Setup button
The following options are available:
989803173791 Rev 0.6 Chapter 3: Preparation for Use 41
•
Alarm Limits: Allows you to access the Alarm Limits menu (see below).
•
Brightness: Allows you to set the desired intensity of the display, where:
– 3 (Brightest)
– 2 (Bright)
– 1 (Normal)
NOTE
Brightness options higher than the Normal setting will reduce battery run time.
•
Service: Allows you to access the Service menu (see below).
Service Menu
The Service menu allows you to examine the status of the hardware and software revision levels,
and to set the language displayed by the monitor. Other options remain reserved for use by
qualified service providers, as noted below.
To enter the Service menu:
Touch the Setup button and then Service.
Service menu
Setup menu
Setup button
The following options are available:
•
42
Status: Allows you to check the Real Time Clock, and to display the communication status
of the module and the main battery.
Chapter 3: Preparation for Use 989803173791 Rev 0.6
•
Revision Info: Allows you to examine the firmware and software level of the boot loader,
application and power programs.
•
Demo Mode: Allows system operations to be simulated; see the service manual for details.
NOTE
The correct password is required for access: 12151.
WARNING
Warning
The Essential MRI Patient Monitor (Model 865353) is equipped with a simulation mode that
displays computer generated data for training purposes. As a safety feature, a “Demo Mode”
message is displayed while in simulation mode. Do not attach a patient to the system when in
simulation mode and do not activate simulation mode when a patient is connected to the
system. The system will not monitor patients while in the simulation mode. Failure to properly
monitor the patient will result. To exit simulation mode, turn off Demo Mode using the menu,
or power off the monitor, or remove the battery.
•
Radio: Allows a service provider to change the radio and to test radio power; see the
service manual for details.
NOTE
The correct password is required for access.
•
Language: Allows you to set the language used to display menus, messages and interface
items, where the following options are available:
–
–
–
–
–
–
–
–
–
–
English
Espanol
Deutsch
Francais
Nederlands
Dansk
Svenska
Italiano
Norsk
Portugues
989803173791 Rev 0.6 Chapter 3: Preparation for Use 43
Network Menu
The Network menu allows you to set the network used by the monitor to communicate with the
WSpO2 module. For proper communications, the monitor and module must be linked on the same
network. For ease of identification, network selection buttons have unique shapes, designators
and colors. (To change the module’s network setting, see Assigning the Module Network in
Chapter 2.)
WARNING
Warning
If the message box, “WARNING! MULTIPLE WIRELESS MODULES DETECTED ON NETWORK” is
displayed, recheck the desired configuration of the module and monitor. In environments
where multiple systems are being used, you must be aware of each system’s network setting.
Operating multiple systems on the same network (or with an incorrect network setting) will
interfere with communications, and incorrect patient vital signs information may be obtained
and displayed as a result. Before proceeding, you must resolve the conflicting assignments.
NOTE
The network button is dynamic, changing to reflect the current network setting.
To enter the Network menu:
Touch the Network button.
Network menu
Network button
Network selection buttons
The following options are available by pressing the associated Network selection button:
44
•
(Network 1): Allows you to set system communications for wireless network 1
(compatibility with a Precess MRI Patient Monitor and module, Model 3160 ‐ Blue version).
•
(Network 2): Allows you to set system communications for wireless network 2
(compatibility with a Precess MRI Patient Monitor and module, Model 3160 ‐ Blue version).
Chapter 3: Preparation for Use 989803173791 Rev 0.6
•
(Network 3): Allows you to set system communications for wireless network 3
(compatibility with a Precess MRI Patient Monitor and module, Model 3160 ‐ Blue version).
•
(Network 4): Allows you to set system communications for wireless network 4
(compatibility with a Precess MRI Patient Monitor and module, Model 3160 ‐ Blue version).
•
(Network 5): Allows you to set system communications for wireless network 5
(compatibility with a Precess MRI Patient Monitor and module, Model 3160 ‐ Blue version).
•
(Network A): Allows you to set system communications for wireless network A
(compatibility with an Expression MRI Patient Monitor and module, Model 865214).
•
(Network B): Allows you to set system communications for wireless network B
(compatibility with an Expression MRI Patient Monitor and module, Model 865214).
•
(Network C): Allows you to set system communications for wireless network C
(compatibility with an Expression MRI Patient Monitor and module, Model 865214).
•
(Network D): Allows you to set system communications for wireless network D
(compatibility with an Expression MRI Patient Monitor and module, Model 865214).
•
(Network E): Allows you to set system communications for wireless network E
(compatibility with an Expression MRI Patient Monitor and module, Model 865214).
Alarm Limits Menu
The Alarm Limits menu allows you to set limits for the SpO2 and HR (heart rate) alarms, and to
control the presence of these settings on the display. During patient monitoring when a vital sign
has violated an alarm limit, a high priority alarm is declared; see Managing Alarms in Chapter 4
for details.
WARNINGS
• Always respond promptly to any alarm condition.
•
Setting the alarm limits to extreme values can render the alarm monitoring useless. A
potential hazard can exist if different alarm monitoring settings are used for the same or
similar equipment in any single patient care unit.
•
Alarms generated by the Essential MRI Patient Monitor (Model 865353) will not
synchronize with other patient monitoring systems.
•
Alarm limits can be set to a wide range of values, including Off. It is the responsibility of
the operator of the system to ensure that alarm limit values appropriate for each patient
are established and set.
989803173791 Rev 0.6 Chapter 3: Preparation for Use 45
NOTES
•
The system automatically prevents crossover of the low and high alarm limit settings.
•
Alarm limit setting changes are saved when power is turned off or when changing the
battery.
•
When the patient category is changed, factory default alarm limit settings are used.
To enter the Alarm Limits menu:
•
Touch the Alarms button.
Alarm Limits can also be accessed by:
– Touching the SpO2 or HR vital sign numeric,
– Touching a specific alarm limit indicator (for direct access to that setting), or
– Touching the Setup button and then Alarm Limits.
Alarms button
Default Limits button
SpO2 vital sign numeric
Alarm Limits menu
SpO2 high alarm limit indicator
Display Limits button
SpO2 low alarm limit indicator
HR high alarm limit indicator
HR low alarm limit indicator
HR vital sign numeric
Increment button
Decrement button
HR Alarm Limits buttons
SpO2 Alarm Limits buttons
The following options are available:
•
46
SpO2 Alarm Limits buttons: Indicates the current setting and allows you to set the limits
for the SpO2 alarm, adjusted by touching the button (High or Low) followed by the
increment or decrement button.
Chapter 3: Preparation for Use 989803173791 Rev 0.6
•
HR Alarm Limits buttons: Indicates the current setting and allows you to set the limits for
the HR (heart rate) alarm, adjusted by touching the button (High or Low) followed by the
increment or decrement button.
•
Decrement button: Allows you to decrease an Alarm Limits setting, where touching it once
decreases the count by one and holding it decreases the count continuously.
•
Increment button: Allows you to increase an Alarm Limits setting, where touching it once
increases the count by one and holding it increases the count continuously.
•
Default Limits button: Allows you to automatically change the low and high alarm limits
for both parameters to the default settings (see the tables below).
•
Display Limits button: Allows you to control the presence of the high and low alarm limit
indicators for SpO2 and HR, where a checked box displays the indicators.
•
SpO2 vital sign numeric: Indicates the SpO2 vital sign of the patient (given as a percentage)
and allows you to change to the SpO2 alarm limits, where touching it opens the Alarm
Limits menu.
•
HR vital sign numeric: Indicates the heart rate vital sign of the patient (given in beats per
minute) and allows you to change to the heart rate alarm limits, where touching it opens
the Alarm Limits menu.
•
SpO2 high alarm limit indicator: Indicates and allows direct changes to the high limit
setting for the SpO2 alarm, where touching it opens the Alarm Limits menu.
•
SpO2 low alarm limit indicator: Indicates and allows direct changes to the low limit setting
for the SpO2 alarm, where touching it opens the Alarm Limits menu.
•
HR high alarm limit indicator: Indicates and allows direct changes to the high limit setting
for the heart rate alarm, where touching it opens the Alarm Limits menu.
•
HR low alarm limit indicator: Indicates and allows direct changes to the low limit setting
for the heart rate alarm, where touching it opens the Alarm Limits menu.
Neonatal Alarm Limits
Vital Sign
Parameter
Unit
SpO2
HR
Low Limit
High Limit
MIN
MAX
Default
MIN
MAX
Default
Percent
50
99
90
70
99
Off
BPM
30
249
90
60
249
210
Pediatric Alarm Limits
Vital Sign
Parameter
Unit
SpO2
HR
Low Limit
High Limit
MIN
MAX
Default
MIN
MAX
Default
Percent
50
99
90
70
99
Off
BPM
30
249
75
60
249
160
989803173791 Rev 0.6 Chapter 3: Preparation for Use 47
Adult Alarm Limits
Vital Sign
Parameter
Unit
SpO2
HR
Low Limit
High Limit
MIN
MAX
Default
MIN
MAX
Default
Percent
50
99
85
70
99
Off
BPM
30
249
45
60
249
160
To change an alarm setting, follow the steps below:
Step
Action
If a change in the patient category is needed, touch the Patient
category button then make that change; otherwise, proceed to
Step 2.
Touch the Alarms button
Touch the high or the low Alarm Limits button for the parameter.
(The touch tone will sound and the button will be highlighted.)
The example below follows a SpO2 high alarm limit change.
Touch the decrement or the increment button until the desired
setting is reached, as displayed in the highlighted Alarm Limits
button.
For example, the decrement button was touched twice, resulting in
a high alarm limit of 98.
48
Repeat Steps 2 and 3 to adjust additional alarm limits.
Chapter 3: Preparation for Use 989803173791 Rev 0.6
6
Touch the confirm and close button to save your changes.
If Display Limits are enabled, the alarm setting(s) will be indicated
by the high and low alarm limit indicators. (This completes the
procedure.)
Sound Menu
The Sound Menu allows you to adjust the volume level of the alarm, touch and pulse tones
produced by the monitor.
To enter the Sound menu:
Touch the Speaker button.
Speaker button
Sound menu
Alarm volume buttons
Touch volume buttons
Pulse volume buttons
The following options are available:
•
Alarm volume buttons: Sets the volume (range is 1 – 5) of the tone generated during an
alarm condition, where touching the decrement button (left) lowers the volume or
touching the increment (right) button increases the volume.
989803173791 Rev 0.6 Chapter 3: Preparation for Use 49
WARNING
Warning
Adjustable for suitability to various clinical environments, the alarm volume can be turned low
but never completely off. Always ensure that the alarm volume setting is appropriate for each
patient. When you use the system, always verify that the alarm tone can be heard above the
ambient noise level. Be sure the minimum alarm volume setting is still audible during MRI
scanning because in some environments a particular setting is barely audible. Do not rely
exclusively on the audible alarm system for patent monitoring. Adjustment of the alarm
volume to a low level during patient monitoring may result in patient danger. Remember the
most reliable method of patient monitoring combines close personal surveillance with correct
operation of monitoring equipment.
50
•
Touch volume buttons: Sets the volume (range is 0 – 5) of the tone generated when an
active area of the display panel is touched, where touching the decrement button (left)
lowers the volume or touching the increment (right) button increases the volume.
•
Pulse volume buttons: Sets the volume (range is 0 – 5) of the tone generated when a pulse
is detected, where touching the decrement button (left) lowers the volume or touching the
increment (right) button increases the volume.
Chapter 3: Preparation for Use 989803173791 Rev 0.6
Chapter 4: Monitoring SpO 2
The pulse oximetry feature uses a motion‐tolerant signal processing algorithm based on Fourier
Artifact Suppression Technology (FAST) to provide oxygenated hemoglobin measurements 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).
•
Plethysmographic waveform: A visual indication of the patient’s pulsatile blood flow.
•
Heart rate: The number of detected pulsations per minute.
•
Perfusion index value: A numeric value for the pulsatile portion of the measured signal
caused by arterial pulsation.
SpO 2 Sensor and Wireless SpO 2 Module
The SpO2 sensor and wireless SpO2 (WSpO2) module may be used in the MR system bore,
although the module must not be placed within the MRI field of view (FOV). Invivo‐specified fiber
optic SpO2 sensors and the WSpO2 module are designed for use in the MR environment. Use only
the specified fiber optic SpO2 sensors; see Accessories in Chapter 1 for a listing.
WARNING
Connecting SpO2 sensors other than those specified by Invivo into the WSpO2 module can
cause inaccurate SpO2 readings or damage the module.
CAUTIONS
• If dropped, the WSpO2 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.
989803173791 Rev 0.6 Chapter 4: Monitoring SpO2 51
Connecting the Sensor and Attachments to the WSpO 2 Module
Verify the SpO2 sensor and WSpO2 module status as follows:
Step
Action
Press the power switch for about 0.5 seconds.
After the monitor is on, check the main
battery indicators to ensure sufficient power.
NOTE
Use Alarms Pause to temporarily disable the alarm functions.
Connect a SpO2 sensor to the module.
Connect the attachment (clip or grip) to the SpO2 sensor.
Check the status indicator on the module to verify sufficient power
and good communications for monitoring:
• Solid green = Good battery power and good communications
• Flashing green = Good battery power but no communications
• Solid red = Low battery power and good communications
• Flashing red = Low battery power but no communications
Proceed to Applying and Positioning the SpO2 Sensor, below.
WSpO2 module
SpO2 sensor
SpO2 attachment (clips or grips)
52 Chapter 4: Monitoring SpO2 989803173791 Rev 0.6
Patient Preparation
To prepare a patient for MRI SpO2 monitoring, follow the instructions below.
Applying and Positioning the SpO 2 Sensor
Apply the WSpO2 attachment to the patient as follows:
Step
Action
Follow the Instructions for Use provided with the SpO2 sensor,
adhering to all warnings and cautions, and choose an application
site.
If present, remove any colored nail polish from the application site.
Apply the attachment to the patient. The application site should
match the size of the attachment used, so that the sensor does not
fall off the site or apply excessive pressure to the site (see the
Warnings, below).
Ensure the sensor is not placed within the MRI Field of View (FOV).
Check that the light emitter and the photodetector are directly
opposite each other, as the light must pass through the patient’s
tissue to the photodetector for proper operation.
Proceed to Measuring SpO2, below.
WARNINGS
• GENERAL SENSOR FIT: If a sensor is too loose, it might compromise the optimal
alignment or dislocate. If the sensor 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 sensor being attached to one location for too long.
Periodically inspect the sensor application site and change the application site at least
every four hours. Exercise care when using tape to secure the sensor, as the stretch
memory properties of most tapes can apply unintended pressure to the sensor site
easily.
•
EXTREMITIES TO AVOID: Avoid placing the sensor 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.
NOTE
At system power‐up, if the monitor has communication with the module but the module
attachment is not connected to the patient, no alarm will be declared.
989803173791 Rev 0.6 Chapter 4: Monitoring SpO2 53
Positioning the WSpO 2 Module
The selected site, sensor position, attachment connection, and ambient environment all impact
performance and operation during SpO2 monitoring. To ensure best possible results from the
WSpO2 module during harsh scan sequences (with peripheral nerve stimulation [PNS] levels
above 80 percent), observe the following general placement rules:
– Place the WSpO2 module on or near the patient, as close as possible to the bore iso‐
center (considering the scan to be performed), but keep the wireless module outside
the FOV.
– Place the WSpO2 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 WSpO2 module on a cushioned surface to minimize the MR vibrations.
WARNING
If the WSpO2 module is incorrectly positioned when used within the MR system room, the
following factors can cause SpO2 waveform distortion and 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;
•
The distance from the MR bore opening; and,
•
The distance from the bore iso‐center in the x, y, or z directions.
54 Chapter 4: Monitoring SpO2 989803173791 Rev 0.6
Measuring SpO 2
To display functional SpO2 values, follow the instructions below:
Step
Action
Select the patient category (Adult, Pediatric, or Neonatal).
During measurement, ensure that the application site:
•
has a pulsatile flow, ideally with a perfusion index value
above 1.0; and,
•
has not changed in thickness (for example, due to edema)
causing an improper sensor fit.
NOTE
A pulse oximeter should be considered an early warning device. As a trend towards patient
deoxygenation is indicated, blood samples must be analyzed by a laboratory co‐oximeter to
understand the patient’s condition completely.
Waveform and Vital Sign Information
The waveform and vital sign numeric data provides important physiological information, as
detailed in the table below.
989803173791 Rev 0.6 Chapter 4: Monitoring SpO2 55
Item Number
Explanation
The SpO2 (pleth) pulsatile waveform, updated from left to right across the
display panel. If the pulse is above a minimum level, the amplitude of the
waveform will automatically be adjusted for proper viewing. If you need an
indication of change in pulse volume, use the perfusion index value
described in item 4.
The SpO2 numeric is the patient's arterial oxygen saturation reading, given
as a percentage. Also, if Displayed Limits are set to on, the SpO2 alarm
settings are shown in the high and low alarm limit indicators.
NOTE
Averaging time is fixed and may be overridden by Expression or Precess
workflow.
The HR numeric is the patient’s heart rate, as derived from the SpO2
measurement, given in beats per minute. Also, if Displayed Limits are set to
on, the HR alarm settings are shown in the high and low alarm limit
indicators.
No Data Available Indication
Under certain conditions, the vital sign numerics and/or
the perfusion index value may be displayed as 3 dashes
(‐ ‐ ‐), which means no data is currently available for the
parameter(s). This can happen for any of the following
reasons:
•
The parameter is in a start‐up state;
•
The SpO2 sensor is not applied to the patient;
•
There is no communication with the module; or
•
The measurement is distorted, the pulse too weak
or the signal inadequate in any respect.
NOTES
•
If the system was just turned on or if the probe was just applied, give the monitor a
moment to lock onto the wireless signal.
•
If this condition persists, ensure that the network setting is the same for the module and
the monitor, and that the communication between the devices is good.
56 Chapter 4: Monitoring SpO2 989803173791 Rev 0.6
Assessing Suspicious SpO 2 Readings
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 via an ECG. This
does not indicate an inaccurate SpO2 value. If you doubt the measured SpO2, use the
plethysmography wave and perfusion index value to assess the signal quality.
WARNINGS
• Always shield the SpO2 sensor from extraneous incidental light sources (for example,
cover the sensor with opaque material), 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
heart beats, diagnostic testing, low perfusion, electromagnetic interference,
electrosurgical units, dysfunctional hemoglobin, intravascular dyes, presence of dyes or
pigments at the application site, and inappropriate positioning of the pulse oximeter
probe. If questionable readings are obtained, check the patient’s vital signs by alternate
means before administering medication.
•
Sensor movement, ambient light (especially strobe lights or flashing lights), or
electromagnetic interference can give unexpected intermittent readings when the sensor
is not attached to a patient. Bandage and grip sensor designs are particularly sensitive to
minimal sensor movement that might occur when the sensor is dangling, not attached to
the patient. Unapplied sensors may cause readings to be displayed on the monitor. To
avoid misdiagnosis, verify sensor is applied to patient correctly.
Perfusion Index Value
The perfusion index value is an indication of the pulsatile portion of the SpO2 signal caused by
the patient's arterial blood flow. This value can be used as a quality indicator of the SpO2
measurement from the module. The table below provides general guidelines regarding this index
value, as well as the corrective actions needed when a “Low Perfusion” alarm is generated,
Perfusion Index Value
Meaning
Above 1.0
Optimal – high quality readings
0.3 to 1.0
Acceptable – good quality readings
Marginal – the position of the attachment should be adjusted or
another site should be used for measurement.
Below 0.3
989803173791 Rev 0.6 Chapter 4: Monitoring SpO2 57
Yellow alarm light
Message
Perfusion index value
Managing Alarms
Access to every parameter alarm is provided by the Alarms button (see Alarm Limits Menu in
Chapter 3 for details). Alarm limits may be turned on, adjusted (manually or automatically) or
turned off using the Alarm Limits menu. The system gives visual alarm signals (on the display
panel and by the alarm light) and audible signals.
Alarm Types, Priorities and Indications
The Essential MRI Patient Monitor (Model 865353) assigns different priorities and indications
when reporting alarms. Alarms are assigned a high or medium priority status by the system
according to the type of violation: physiological or technical.
NOTES
•
High priority alarms sound levels range from at least 53dB (a minimum volume setting) to
84dB (maximum volume setting) in 1m distance.
•
Medium priority alarms sound levels range from at least 49dB (a minimum volume setting)
to 71dB (maximum volume setting) in 1m distance.
•
The delay time of making visual and audible alarms available from the alarming equipment
to the remote equipment at the signal output port is less than 1 second. In the case of
artifact or poor signal conditions, update time of SpO2 and HR numerics can take as long as
30 seconds. Alarm limit violations are reported as a high priority alarm within 1 second.
58 Chapter 4: Monitoring SpO2 989803173791 Rev 0.6
Physiological Alarm Violations
Physiological alarms receive the highest priority reporting status. A physiological alarm is violated
when a patient parameter (SpO2 or heart rate) exceeds the high or low setting of the
corresponding alarm limit. The reaction of the system to a physiological alarm depends upon the
settings described below and generally as follows:
a. The alarm light flashes red (see illustration below).
b. If SpO2 related, a red waveform is displayed.
c. The numeric of the violated parameter flashes red.
d. The high priority alarm tone sounds‐‐at a high pitch‐‐5 pulse tones followed by a 1
second delay then 5 pulse tones, repeating every 5 seconds.
e. The numeric continues to flash while the parameter violates its alarm limit, even after
the alarm tone has been muted by touching the Alarms Silence button.
f. If the numeric exceeds the highest value that can be displayed, OVR will be indicated
in the parameter numeric.
g. The numeric stops flashing after the parameter returns to within its alarm limits.
h. The displayed numeric of the violated parameter flashes and the audible alarm, once
silenced, will not sound again until the alarm condition has been corrected and re‐
violated. Only a second different parameter alarm will cause the alarm sound and
alarm light to reactivate.
Example, visual physiological alarm indicators:
Red alarm light
Red vital sign numeric
Physiological alarm testing can be performed using a patient SpO2 simulator to exceed an
individual alarm limit. Alarm testing can also be performed using the monitor’s Demo mode
where an individual parameter alarm limit can be adjusted‐‐a high limit set below the simulated
numeric or a low limit set above the simulated numeric (except SpO2)‐‐to trigger a physiological
alarm. If a problem with the alarm tone or message system is suspected, this system must be
referred to an Invivo‐authorized service personnel for evaluation.
989803173791 Rev 0.6 Chapter 4: Monitoring SpO2 59
Technical Alarm Violations
Technical alarms receive a medium priority reporting status. A technical alarm is violated when a
change in system status or a problem with the hardware or the measurement is detected (for
example ‐ a low battery, a communications failure, or a SpO2 inoperative condition).
NOTES
•
At system power‐up, if the monitor does not have communication with the module, a
medium priority alarm will be declared.
•
At module power‐up, if communication with the module battery is lost, a medium priority
alarm will be declared.
•
If the system loses communication with the main battery, a medium priority alarm will be
declared.
The reaction of the system to a technical alarm depends upon specific system operations and
generally as follows:
a. The alarm light flashes yellow (see illustration below).
b. The medium priority alarm tone sounds‐‐at a low pitch‐‐3 pulse tones followed by a
10 second delay, repeating.
c. Messages are displayed in yellow (except for low battery or communications failure
conditions) to identify the cause of the alarm; see System Messages, below, for the
listing.
d. If a low battery condition exists, the corresponding battery indicator and time
remaining counter will flash in yellow.
e. If a communications failure exists, the corresponding symbol will flash in yellow (the
No Comm symbol
for monitor to module communications, or the No Battery
Communication symbol
for monitor to main battery communications).
f. The alarm condition stops after the problem is corrected or the system status returns
to a normal condition.
g. The message flashes and the audible alarm, once silenced, will not sound again until
the alarm condition has been corrected and re‐violated. Only a second different
parameter alarm will cause the alarm sound and alarm light to reactivate.
60 Chapter 4: Monitoring SpO2 989803173791 Rev 0.6
Example, visual technical alarm indicators:
Yellow alarm light
Low battery, module
Low battery, monitor
Alarm Controls
Alarms can be controlled using the Alarms Silence button or the Alarms Pause button.
WARNINGS
• When alarm indicators (light, message, or sound) are generated, always confirm alarm
conditions with clinical observation of the patient before administering interventions.
Failure to do so may result in inappropriate intervention.
•
Once the numeric has exceeded the alarm limit, the delay to announcing the alarm
condition is less than 1 second, and the total alarm delay is less than 1 second.
Alarms Pause button
Alarms Silence button
•
Alarms Silence button: Allows you to mute the alarm tone and turn off the alarm light
during an alarm condition (although alarm indications will continue to be displayed). When
989803173791 Rev 0.6 Chapter 4: Monitoring SpO2 61
selected, the “Alarms Silenced” message, flashing in red, will be displayed in the
informational message area. A new alarm condition will cause reactivation of the sound
and light functions.
WARNING
Warning
An active silenced alarm may not be accompanied by an “ALARMS SILENCED” message if
Alarms Pause has been activated, or if a subsequent additional alarm has occurred and was
self‐corrected.
•
Alarms Pause button: Allows you to temporarily deactivate the alarm functions (helpful,
for example, when prepping a patient for monitoring). When selected, the “Alarms
Paused” message and a 2 minute countdown timer, flashing in red, will be displayed in the
informational message area.
NOTE
Alarm functions are restored when the countdown timer reaches zero (0) or when the Alarms
Pause button is touched during the countdown.
System Messages
The following table lists messages that can be displayed by the system during operation, and
provides meanings, probable causes and recommended actions (if needed) for problem
resolutions. If the message persists after performing the recommended action(s), contact Invivo
Technical Support or Invivo‐authorized service personnel for assistance.
Message
Meaning
Probable Cause
Recommended Action
Alarms Paused
Alarms are paused
until the countdown
timer reaches zero.
The Alarms Pause
button was touched.
No action required. Normal alarm monitoring
function will resume upon expiration of the
countdown (or immediately if Alarms Pause is
touched again.)
Alarms Silenced
Alarms have been
silenced.
The Alarms Silence
button was touched.
Touch the Alarms Pause button twice to
return normal alarm monitoring functions.
Bad Probe
The system has
detected a
hardware failure in
the sensor.
Erratic
measurements are
being produced by
the system.
The SpO2 sensor is
defective.
Try another SpO2 sensor.
Erratic
The SpO2 sensor is
not properly applied
to the patient, is not
properly positioned,
or the probe is faulty.
62 Chapter 4: Monitoring SpO2 989803173791 Rev 0.6
• Check the alignment of the probe.
• Try using a different probe.
Message
Meaning
HW FAIL
INTRFERNCE
LOW PERFUSION
NO PROBE
NON‐PULSAT
NOISE
PROBE OFF
PULSE?
Probable Cause
Recommended Action
SpO2 hardware
failure.
A hardware or other
fatal error has
occurred inside the
wireless module or
the monitor.
Try another WSpO2 module. If the failure
persists, immediately remove the system from
service and contact Invivo for repair, as the
system must not be used on any patient
requiring SpO2 measurement.
The signal quality of
the light channels is
inadequate for
accurate saturation
calculation.
The probe light
source may not be
aligned with the light
receiver, or the
probe may be poorly
positioned.
The perfusion
measured is low
enough to cause
possible
inaccuracies in the
reported saturation
value.
The WSpO2 module
detects that no
probe is connected.
The tissue at the site
may be too opaque
and/or thick.
If the sensor is positioned on a finger, check
the fingernail for nail polish, or long or
artificial fingernails. Remove fingernail polish
completely. For artificial nails, try another
location (for example, a toe).
The SpO2 probe is
not connected (or is
not properly
connected) to the
module.
Check the connection of the probe to the
WSpO2 module. If connection appears sound,
try another probe.
Non‐pulsatile
condition.
Check the condition
of the patient.
• Check the probe position and alignment on
the patient, then re‐position or re‐apply as
necessary.
The patient’s pulse is
too weak for the
system to report
reliable SpO2
saturation and pulse
measurements.
• Try a different limb or site.
Patient motion or
electrical
interference is being
experienced by the
SpO2 system.
Excessive patient
motion or electrical
noise.
• Check for patient motion, especially at the
monitored site.
The system detects
that the probe is not
applied to the
patient.
The SpO2‐derived
pulse rate is outside
the detectable
range.
The SpO2 sensor is
not properly applied
to the patient.
The probe may not
be applied optimally
or the tissue at the
applied site may too
opaque.
• Check the alignment of the probe.
• Try a different limb or site.
• Try using a different probe.
• Ensure that the probe is positioned so that
the sensors are not exposed to excessive
levels of ambient light.
Check probe position and alignment on the
patient, then reposition or reapply it as
necessary.
• Check the alignment of the probe.
• Try a different limb or site.
989803173791 Rev 0.6 Chapter 4: Monitoring SpO2 63
Message
Meaning
Probable Cause
Recommended Action
SEARCHING
The system is
searching for a good
pulse.
The probe was just
applied to the
patient, or the probe
has shifted position
since being applied.
If the probe was just applied, give the system
time (usually less than 20 seconds) to lock
onto a good pulse; otherwise, check the probe
position and re‐position.
The system has
detected that an
incorrect probe is
connected to the
module.
The probe connected
to the module is
wrong.
Attach the correct SpO2 sensor to the module.
WRONG PROBE
64 Chapter 4: Monitoring SpO2 989803173791 Rev 0.6
Chapter 5: Workflow
The Essential MRI Patient Monitor (Model 865353) can be used in conjunction with the Expression
MRI Patient Monitor (Model 865214) and the Precess MRI Patient Monitor (Model 3160 ‐ Blue
version) to provide seamless patient monitoring from induction to scanning to recovery.
Expression MRI Patient Monitor
(Model 865214)
Precess MRI Patient Monitor
(Model 3160 ‐ Blue version)
When using the Essential with these other Invivo MRI monitors, observe the following warnings
and notes.
WARNINGS
• Alarm limit settings do not transfer between monitoring systems and may be different,
so always ensure correct alarm limit settings when using multiple monitoring systems.
•
All SpO2 modules must be on different networks; otherwise, interference, or wrong
patient or alternating pickup between patients can occur.
NOTES
•
The Essential MRI Patient Monitor (Model 865353) is not compatible with the original
Precess WSpO2 module.
•
The numerics and waveform are generated by the WSpO2 module, and therefore are
identical regardless of the monitoring system used.
989803173791 Rev 0.6 Chapter 5: Workflow 65
NOTES
• To establish patient monitoring, the Essential must be communicating on the same network
as the module and attached to the patient.
•
Monitor settings (for example, patient category, alarm limits, etc.) do not transfer between
monitoring systems, and alarm behavior remains linked to the alarm limit settings and the
detected numerics.
Workflow Management
The following diagrams illustrate typical and alternate workflow objectives when using the
Essential as a standalone device or when using it together with compatible Invivo MRI monitors.
NOTE
The network settings and groupings used below are given as examples only; your selections may
differ. However, the network conventions (A‐E or 1‐5) as well as the grouping of the settings
(network A versus B, 1 versus 2, etc) should be observed.
Workflow when using the Essential as a standalone monitor with one WSpO2 module:
•
A patient, an MR induction room, an MR system room and an MR recovery room.
– The Essential and the WSpO2 module are set to network A or network 1, depending
upon the module type (Expression or Precess ‐ Blue version).
Step
Action
Prep the patient in the MR induction room.
Turn on the Essential and the WSpO2 module. Both are set to
network A (or 1).
Verify sufficient power and good communications.
Apply the SpO2 sensor to the patient.
66 Chapter 5: Workflow 989803173791 Rev 0.6
5
Set the patient category and verify pulsatile flow.
Transport the patient with the Essential into the MR system room.
Scan the patient, monitoring SpO2 with the Essential through the
control room window.
Transport the patient with the Essential and the WSpO2 module
into the MR recovery room.
Transition the patient into the MR recovery room to bedside
monitoring, if needed, then take the Essential and the WSpO2
module into the MR induction room for the next patient.
Workflow when using the Essential with an Expression (or a Precess ‐ Blue version) system and
one WSpO2 module:
•
A patient, an MR induction room, an MR system room with an Expression (or a Precess)
and an MR recovery room.
– The Essential, the Expression and the WSpO2 module are set to network A (or if using
a Precess ‐ Blue version, network 1).
Step
Action
Prep the patient in the MR induction room.
Turn on the Essential and the WSpO2 module. Both are set to
network A (or 1 if using a Precess).
Verify sufficient power and good communications.
Apply the SpO2 sensor to the patient.
Set the patient category and verify pulsatile flow.
Transport the patient with the Essential into the MR system room
for scanning, where the Expression is set to network A (or if using a
Precess, network 1).
989803173791 Rev 0.6 Chapter 5: Workflow 67
7
In the MR system room, connect the patient to the additional vital
signs measurements then adjust the alarm limits, patient category,
and other settings as needed on the Expression (or Precess). As
soon as the WSpO2 module is within range, the Expression [or
Precess] will begin monitoring SpO2 automatically and you can turn
off the Essential.
Scan the patient, using the Expression (or Precess) in the control
room.
Turn on the Essential to monitor SpO2. (The Essential will now begin
to monitor SpO2 automatically.)
10
In order to transport the patient to the MR recovery room,
disconnect the patient from all vital sign measurements except
SpO2 provided by Expression (or Precess).
11
Transport the patient with the Essential and the WSpO2 module
into the MR recovery room.
12
If needed, transition the patient in the MR recovery room to
bedside monitoring. Take the Essential and the WSpO2 module into
the MR induction room for the next patient.
Workflow when using the Essential with an Expression (or a Precess ‐ Blue version) system and
two WSpO2 modules:
•
Two patients simultaneously, an MR induction room, an MR room with an Expression (or a
Precess) and an MR recovery room.
– The Expression and a WSpO2 module are set to network A (or for Precess, network 1).
– The Essential and a WSpO2 module are set to network B (or for Precess, network 2).
Step
Action
One (current) patient is in the MR system room, where an
Expression and WSpO2 module are set to network A (or if using a
Precess, network 1).
Prep the second (new) patient in the MR induction room.
68 Chapter 5: Workflow 989803173791 Rev 0.6
3
Turn on the Essential and the WSpO2 module. Both are set to
network B (or if using a Precess, network 2).
Verify sufficient power and good communications.
Apply the SpO2 sensor to the new patient.
Set the patient category and verify pulsatile flow.
When the scan of the current patient has finished, transport the
new patient with the Essential and the WSpO2 module into the MR
system room.
From the current patient in the MR system room, disconnect the
sensor from the SpO2 Quick Connect attachment (grip).
NOTE
Press the Alarms Silence key to temporarily disable the alarm
functions.
From the new patient in the MR system room, disconnect the
sensor from the SpO2 Quick Connect attachment (grip).
NOTE
Touch the Alarms Pause button to temporarily disable the alarm
functions.
10
In the MR system room, connect the new patient to the additional
vital measurements on the Expression, still on network A (or the
Precess, still on network 1).
11
Transport the current patient with the Essential and the WSpO2
module, still on network B (or for the Precess still on network 2)
into the MR recovery room.
12
If needed, transition the current patient in the MR recovery room
to bedside monitoring. Take the Essential and the WSpO2 module
into the MR induction room for the next patient.
13
Scan new the patient, using the Expression DCU (or the Precess
CRD) in the control room.
989803173791 Rev 0.6 Chapter 5: Workflow 69
Workflow when using the Essential with a Precess (Blue version) system, two WSpO2 modules
and two ECG modules:
•
Two patients simultaneously, an MR induction room, an MR room with a Precess and an
MR recovery room.
– The Precess, a WSpO2 module and an ECG module are set to network 1.
– The Essential, a WSpO2 module and an ECG module are set to network 2.
Step
Action
One (current) patient is in the MR system room, where a Precess, a
WSpO2 module and a ECG module are set to network 1.
Prep the second (new) patient in the MR induction room.
Turn on the Essential, the WSpO2 module and the ECG module. All
are set to network 2.
Verify sufficient power and good communications. (The ECG
module cannot not be checked at this point.)
Apply the SpO2 sensor and the ECG leads to the new patient.
Set the patient category and verify pulsatile flow.
When the scan of the current patient has finished, transport the
new patient with the Essential, the WSpO2 module and the ECG
module into the MR system room.
In the MR system room, on the Precess display panel, press the
MONITOR SETUP key. Turn the control knob to NETWORK, press the
knob and select Network 2.
NOTE
Press the Alarms Silence key to temporarily disable the alarm
functions.
In the MR system room, connect the new patient to the additional
vital measurements on the Precess. Verify sufficient power and
good communications for the modules.
70 Chapter 5: Workflow 989803173791 Rev 0.6
10
In the control room, on the Precess CRD display panel, press the
MONITOR SETUP key. Turn the control knob to NETWORK, press the
knob and select Network 2.
11
On the Essential display panel, press the Network button then
select Network 1.
NOTE
Touch the Alarms Pause button to temporarily disable the alarm
functions.
12
Verify sufficient power and good communications for the WSpO2
module. (The ECG module will not be used and cannot not be
checked at this point.)
13
Transport the current patient with the Essential, the WSpO2
module and the ECG module into the MR recovery room.
14
If needed, transition the current patient in the MR recovery room
to bedside monitoring. Take the Essential the WSpO2 module and
the ECG module into the MR induction room for the next patient.
15
Scan new the patient, using the Precess CRD in the control room.
989803173791 Rev 0.6 Chapter 5: Workflow 71
72 Chapter 5: Workflow 989803173791 Rev 0.6
Chapter 6: Maintenance and Repair
Methods to keep the Essential MRI Patient Monitor (Model 865353) clean and in proper working
condition are discussed here.
Maintenance
Cleaning
Use only the Invivo approved substances and methods listed in this section to clean or disinfect
the Essential MRI Patient Monitor (Model 865353). Warranty does not cover damage caused by
using unapproved substances or methods.
Invivo makes 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.
Cleaning the System
The Essential MRI Patient Monitor (Model 865353) cannot be sterilized. Always turn off the
system to perform cleaning. Do not immerse any part of the system in any fluid or attempt to
clean it with liquid cleaning agents. Remove dirt and dust from the monitor and the wireless
module by wiping them with a lint‐free cloth, moistened with warm water (40°C/104°F
maximum). Gently wipe all surfaces to be cleaned briefly (30 seconds to 1 minute) as needed to
ensure proper cleaning. Stains can be removed by scrubbing briskly with the moistened cloth.
If disinfection is required, use only the dilute solutions of any of the following recommended
liquid surface disinfectants:
•
CaviWipes
•
Alcohol (70%)
•
Antibacterial Soap (0.1% Triclosan)
WARNING
To avoid damage to the connector, do not remove the battery before performing any cleaning
or maintenance. And, to avoid an electrical hazard, never immerse any part of the system in
any cleaning agent or attempt to clean it with liquid cleaning agents.
989803173791 Rev 0.6 Chapter 6: Maintenance and Repair 73
CAUTIONS
• Avoid ammonia‐based, phenol‐based, and acetone‐based cleaners. They will damage the
system surfaces.
•
If the system becomes accidentally wet during use, discontinue operation until all affected
components have been cleaned and permitted to dry completely. Contact Invivo Technical
Support if additional information is required.
Cleaning the Accessories
Any reusable patient accessories must be cleaned after each use. Disposable patient accessories
must be discarded and replaced with new items. The accessories cannot be sterilized.
WARNING
Single‐use devices, as indicated on the device packaging, should be disposed of after use and
must never be reused.
CAUTION
Never immerse an accessory in any cleaning fluid.
To clean reusable accessories (such as SpO2 sensors and grips), complete the following steps:
Step
Action
Remove the accessory from use.
Remove dirt and dust from the accessory using a lint‐free cloth,
moistened with warm water (40CF maximum) gently wiping
all surfaces to be cleaned briefly (30 seconds to 1 minute) as
needed to ensure proper cleansing. Stains can be removed from
the accessory by scrubbing briskly with the moistened cloth.
Inspect the accessory for any cracks, holes, tears, cuts, etc. that
could affect operation and replace as necessary.
If disinfection is required, use only the recommended liquid surface
disinfectants, unless otherwise specified in the accessory’s
instructions for use. Recommended surface disinfectants include
dilute solutions of any of the following:
• CaviWipes
• Alcohol (70%)
• Antibacterial Soap (0.1% Triclosan)
CAUTION
Disinfect the accessory as determined by your facility’s policy.
74
Chapter 6: Maintenance and Repair 989803173791 Rev 0.6
Repair
All repairs on products under warranty must be performed by Invivo personnel or an authorized
Invivo Service and Repair Center. Unauthorized repairs will void the warranty.
WARNING
A shock hazard exists if the system is operated without covers.
If the Essential MRI Patient Monitor (Model 865353) fails to function properly or requires
maintenance, contact Technical Support:
In the United States:
1‐877‐INVIVO1
‐or‐
1‐877‐468‐4861
Internationally, please contact your Key Market. For a current listing, go to www.invivocorp.com
CAUTIONS
• No repair should ever be undertaken or attempted by anyone not having a thorough
knowledge of the repair of Invivo patient monitoring systems. Only replace damaged parts
with components manufactured or sold by Invivo (Philips). Contact the Technical Service
and Repair Center for technical assistance and service.
•
This product, or any of its parts, must not be repaired other than in accordance with
written instructions provided by Invivo (Philips), or altered without prior written approval.
Changes and modifications to the radio and its components not expressly approved by
Invivo (Philips) can void your authority to operate this equipment under Federal
Communications Commission’s rules.
•
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 (Philips) or its authorized service personnel.
NOTE
Dispose of the system and parts thereof according to local regulations.
989803173791 Rev 0.6 Chapter 6: Maintenance and Repair 75
76
Chapter 6: Maintenance and Repair 989803173791 Rev 0.6
Appendix A: Specifications
General
Patient Safety
Conforms to UL STD 60601‐1. Certified to CAN/CSA STD C22.2 No. 601.1
According to degree of protection against harmful ingress of water: IPX 2 (equipment is protected from vertically
dripping liquid)
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 60601‐1‐4, General Requirements for Safety of Programmable Electrical Medical Systems
•
IEC 60601‐1‐8, General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical
Equipment and Medical Electrical Systems
•
ISO 9919, Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter
Equipment for Medical use
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.
Power Requirements
Operating Voltage
Battery only
Battery
Type
Lithium polymer
Operation Time
Monitor: Approximate operation time is 8 hours.
Module: Approximate operation time is 8 hours.
Charge Time
Monitor: Time required to recharge a fully discharged battery is
approximately 8 hours.
Module: Time required to recharge a fully discharged battery is
approximately 6 hours.
Environment
Operating Temperature
10°C to 40°C (50°F to 104°F)
Storage Temperature
Batteries: 0°C to 40°C (32°F to 104°F)
System: ‐25°C to 70°C (‐13 to 158°F)
When storing beyond the temperature ranges specified, remove
the designated component and store it appropriately.
Relative Humidity
15 to 90%, non‐condensing
Transport Temperature
‐25°C to 70°C (‐13 to 158°F)
989803173791 Rev 0.6 Appendix A: Specifications 77
Dimensions and Weights (Note: all measurements made including handle)
Height
Monitor: 6.1 inches (155 mm)
Wireless SpO2 Module: 5.5 inches (13.9 cm)
Width
Monitor: 6.9 inches (175 mm)
Wireless SpO2 Module: 2.5 inches (6.4 cm)
Depth
Monitor: 3.7 inches (94 mm)
Wireless SpO2 Module: 0.91 inches (2.3 cm)
Weight
Monitor: 3.3 lbs (1.5 Kg)
Wireless SpO2 Module: 5.2 oz (147 gm)
Display (LCD)
Type
640 x 480 pixels, color VGA Liquid Crystal Display with 5‐Wire
touch screen
Screen Size
5.7 inches (14.5 cm)
Sweep Speed
25 mm/second gives 2.7 seconds of display
Waveform Display Mode
Fixed Trace, Moving Erase Bar
Displayed Parameters
Alarms
High and low limit selectable
Heart Rate
Derived from SpO2
Pulse Oximeter
Heart rate, pulse waveform, percent saturation, and perfusion
index
Pulse Oximeter
Pitch of pulse tone is modulated by saturation value.
78
Saturation Range
0 to 100%
Saturation Accuracy
±3% at 70 to 100% (The specified accuracy is the root‐mean
square (RMS) difference between the measured values and the
reference values)
Pulse Range
30 to 250 bpm
Pulse Accuracy
±2% or 1 bpm, whichever is greater
Wavelength Range
500 to 1000 nm: Information about the wavelength range can be
especially useful to clinicians (for instance, when photodynamic
therapy is performed.
Emitted Light Energy
<15mW: Information about the wavelength range can be
especially useful to clinicians (for instance, when photodynamic
therapy is performed.
Pulse Oximeter Calibration Range
70% ‐ 100%
Appendix A: Specifications 989803173791 Rev 0.6
Alarm Limits
SpO2 Alarm Limits
Low: 50 to 99 or Off
High: 70 to 99 or Off
Heart Rate Alarm Limits
Low: 30 to 249 or Off
High: 60 to 249 or Off
Note:
Measurement validation: SpO2 accuracy has been 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% and 100% SaO2 were studied. The population characteristics for those studies were:
•
•
•
about 50% female and 50% male subjects
age range: 19‐27
skin tone: from light to black
A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor; however, it can be used to
demonstrate that a particular 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
Power Adapter
Power Requirements
Input Voltage (to AC inlet)
Universal AC; 100 to 240VAC @ 50 to 60Hz.
Input Power
0.4 amps, without power factor correction.
DC Connector
15 VDC
Environment
Location
Console room (Outside the MR system room)
Operating Temperature
10°C to 40°C (50°F to 104°F)
Storage Temperature
‐25° to 70°C (‐13°F to 158°F)
Relative Humidity
15% to 90%, non‐condensing
989803173791 Rev 0.6 Appendix A: Specifications 79
80
Appendix A: Specifications 989803173791 Rev 0.6
Appendix B: Warranty
Warranty Statement
Invivo warrants this product, other than its expendable 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 thirty (30) days on expendable parts. This warranty shall become null and void if the
system has been repaired by someone other than Invivo or if the product has been subject to
misuse, accident, negligence or abuse.
Invivo's sole obligation under this warranty is limited to repairing a system which has been
reported to Invivo's Technical Service Center during normal business hours and shipped
transportation prepaid. Invivo 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 Invivo assumes nor authorizes anyone to assume for it any other obligation in
connection with the sale or repair of its products.
INVIVO PRODUCTS CONTAIN PROPRIETARY COPYRIGHTED MATERIAL.
ALL RIGHTS RESERVED
989803173791 Rev 0.6 Appendix B: Warranty 81
82
Appendix B: Warranty 989803173791 Rev 0.6
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 (1995/5/
EC), contact the Regulatory Affairs Department of Invivo:
407‐275‐3220
1‐800‐331‐3220 (Toll‐free)
Internationally, please contact your Invivo sales representative.
Authorized Representative
The Authorized Representative for the European Union (as required by the Medical Device
Directive, 93/42/EEC) is as follows:
Philips Medical Systems Boblingen
GmbH, Hewlett‐Packard‐Str. 2
71034, Boblingen Germany
989803173791 Rev 0.6 Appendix C: Regulatory Information 83
84
Appendix C: Regulatory Information 989803173791 Rev 0.6
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 radiofrequency 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, guidewires, 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 radiofrequency (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:
989803173791 Rev 0.6 Appendix D: Guidelines and References 85
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., leads, electrodes,
etc.), and materials that have been thoroughly tested and determined to be safe and
compatible for MR procedures.
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, 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 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).
86
Appendix D: Guidelines and References 989803173791 Rev 0.6
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.
989803173791 Rev 0.6 Appendix D: Guidelines and References 87
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.
Hall SC, Stevenson GW, Suresh S. Burn associated with temperature monitoring during magnetic
resonance imaging. Anesthesiology 1992;76:152.
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.
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.
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.
Shellock FG. MR safety update 2002: Implants and devices. Journal of Magnetic Resonance
Imaging 2002;16:485‐496.
88
Appendix D: Guidelines and References 989803173791 Rev 0.6
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.
989803173791 Rev 0.6 Appendix D: Guidelines and References 89
90
Appendix D: Guidelines and References 989803173791 Rev 0.6
Notes
91
92
Index
accessories
carry case, 14
miscellaneous, 5
mount adapter, 15
power, 4
roll stand, 16
SpO2, 4
alarm
testing, 59
controls, 61
alarm indicators
physiological, 59
technical, 61
Alarm Limits
decrement button, 47
Default Limits button, 47
increment button, 47
alarm limits
adult, 48
default, 48
neonatal, 47
default, 47
pediatric, 47
default, 47
Alarm Limits Menu, 45
alarm priorities, 59
alarm violations
physiological, 59
technical, 60
Alarms
Types, Priorities and Indications, 58
Alarms button, 33, 34
Alarms Pause button, 33, 62
Alarms Paused, 62
Alarms Silence button, 33, 61
Alarms Silenced, 62
Bad Probe, 62
batteries
charging, 21
external power adapter, 21
battery
main
hibernating condition, 21
installation, 19
removal, 20
module
installation, 20
removal, 21
Cleaning, 73
cleaning
accessories, 74
system, 73
close button, 38
confirm and close button, 38
conventions
cautions, 3
document, 2
notes, 3
system, 2
warnings, 3
Declaration of Conformity, 83
Demo Mode indicator, 33, 34
display panel
overview, 33
Erratic, 62
EU
authorized representative, 83
external power adapter, 21
Guidelines and References, 85
heart rate
Alarm Limits buttons, 47
defined, 51
high alarm limit indicator, 33, 47
low alarm limit indicator, 33, 47
no data available indication, 56
numeric, 56
parameter identifier, 33, 34
vital sign numeric, 33, 47
HW FAIL, 63
Informational message area, 33
INTRFERNCE, 63
LOW PERFUSION, 63
Main battery indicators, 33
Main Screen button, 33, 39
Maintenance and Repair, 73
Managing Alarms, 58
Measuring SpO2, 55
menu change controls, 38
message area
informational, 34
module
network icons, 25
network selection button, 25
sensor connector, 25
status indicator, 25
Module battery indicators, 33
monitor
alarm light, 24
automatic shutdown, 24
display panel, 24
handle, 24
power switch, 24
speaker, 24
Monitoring SpO2, 51
navigation
menu groups and controls, 38
network assignments
module, 25
Network button, 33
Network Menu, 44
Network selection buttons, 44
No Data Available Indication, 56
NO PROBE, 63
NOISE, 63
NON‐PULSAT, 63
patient category
determination, 40
patient category button, 33, 34
Patient Menu, 40
Patient menu
adult, 41
neonatal, 41
pediatric, 41
patient preparation
SpO2 monitoring, 53
perfusion
defined, 51
no data available indication, 56
perfusion index value, 33, 57
Preparation for Use, 37
PROBE OFF, 63
PULSE?, 63
Regulatory Information, 83
Repair, 75
safety
battery disposal, 10
electromagnetic compatibility, 6
EMC emissions, 7
EMC immunity, 8
recommended separation distances, 9
using batteries, 18
screen
locking and unlocking, 39
SEARCHING, 64
Service Menu, 42
Service menu
Demo Mode, 43
language, 43
radio, 43
revision info, 43
status, 42
Setup button, 33
Setup Menu, 41
alarm limits, 42
brightness, 42
service, 42
Sound Menu, 49
alarm volume buttons, 49
pulse volume buttons, 50
touch volume buttons, 50
speaker button, 33, 34
specifications, 77
SpO2
Alarm Limits
decrement button, 47
increment button, 47
Alarm Limits buttons, 46
defined, 51
high alarm limit indicator, 33, 34, 47
low alarm limit indicator, 33, 34, 47
measurement, 55
message area, 33, 34
monitoring
patient preparation, 53
no data available indication, 56
numeric, 56
parameter identifier, 33, 34
processing algorithm, 51
989803173791 Rev 0.6
Index 93
sensor
applying and positioning, 53
sensor and wireless module, 51
suspicious readings, 57
vital sign numeric, 33, 34, 47
waveform, 33, 34, 51, 56
symbols
list, 11
system
battery operation, 18
components, 17
main battery, 18
94 Index
parameters, 38
power‐up, 29
unpacking, 14
System Messages, 62
Using the Monitor, 37
Warranty, 81
Waveform and Vital Sign Information, 55
workflow, 65
989803173791 Rev 0.6
workflow management
Essential standalone, 66
Essential with Expression or Precess and
one module, 67
Essential with Expression or Precess and
two modules, 68
Essential with Precess and two module
sets, 70
WRONG PROBE, 64
WSpO2 module
positioning, 54
verifying connections and status, 52

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