Sotera Wireless VISI-MOBILE Vital Signs Monitoring system User Manual PWD IFU

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Monitoring System
User manual
August 2012
Part Number: 6-000212-01
Reference Number (CD): 95-10100
Reference Number (Hardcopy): 95-10101
9444 Waples Street, Suite 280
San Diego, California 92121 USA
Phone: +1 (866) 794-5526 (U.S.)
+1 (858) 373-4870 (Intl)
Fax:
+1 (858) 427-4639
Email: support@soterawireless.com
EMERGO EUROPE
Molenstraat 15, 2513BH
The Hague
The Netherlands
Information for servicing the ViSi Mobile Monitoring Systems is contained in the ViSi Mobile Monitoring
System Technical Manual, Reference#: 95-10061 (hardcopy) / 95-10059 (CD). For additional information
or assistance, please contact Sotera Wireless or an authorized Sotera Wireless representative in your area.
0297
Copyright
This publication is provided for informational purposes only and Sotera Wireless, Inc. makes no
warranties, either express or implied, in this document. Information in this document is subject to change
without notice. The entire risk of the use or the results of the use of this document remains with the user.
Unless otherwise noted, the example companies, organizations, products, domain names, e-mail addresses,
logos, people, places, and events depicted herein are fictitious, and no association with any real company,
organization, product, domain name, e-mail address, logo, person, place, or event is intended or should be
inferred. Complying with all applicable copyright laws is the responsibility of the user. Without limiting
the rights under copyright, no part of this document may be reproduced, stored in or introduced into a
retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying,
recording, or otherwise), or for any purpose, without the express written permission of Sotera Wireless,
Inc.
Sotera Wireless, Inc. may have patents, patent applications, trademarks, copyrights, or other intellectual
property rights covering subject matter in this document. Except as expressly provided in any written
license agreement from Sotera Wireless, Inc., the furnishing of this document does not give you any
license to these patents, trademarks, copyrights, or other intellectual property.
Information for servicing the ViSi Mobile Monitoring Systems is contained in the ViSi Mobile Monitoring
System Technical Manual, Part Number: 6-000147. For additional information or assistance, please
contact Sotera Wireless or an authorized Sotera Wireless representative in your area.
© 2011 Sotera Wireless, Inc. All rights reserved.
ViSi Mobile Monitoring System is a trademark of Sotera Wireless, Inc.
Contents
Chapter 1. Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Warnings, Cautions and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Chapter 2. General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Removing and Inserting the Shipping Plug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
To remove the Shipping Plug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
To insert the Shipping Plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
ViSi Mobile Patient Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
ViSi Mobile Disposable Cuff. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ECG Electrode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ViSi Mobile Wrist Cradle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ViSi Mobile Thumb Cradle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ViSi Mobile Cable Securement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24
24
25
25
26
ViSi Mobile Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ViSi Mobile Thumb Sensor (SpO2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ViSi Mobile Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ViSi Mobile Chest Sensor Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ViSi Mobile Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
26
27
28
29
30
To set up the Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Charging the ViSi Mobile Monitor and Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . 31
To charge a Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
To charge a Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Chapter 3. Clinical Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Key Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Overview of Clinical Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
ECG Monitoring and Heart Rate (HR) Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Respiration Rate (RESP) Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Skin Temperature (TEMP) Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Pulse Oximetry (SpO2 and Pulse Rate) Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . 38
NIBP Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Display Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Battery Charge Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Hibernation Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vital Signs Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Monitor Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Quiet Monitoring Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient View Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
39
40
41
42
42
43
44
Chapter 4. Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Preparing for a New Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Inspecting the Equipment and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Applying Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Selecting Vital Signs to Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Selecting the ViSi Mobile Chest Sensor Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Selecting the ViSi Mobile Patient Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Checking the Battery Charge of the ViSi Mobile Monitor
and Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
45
46
47
47
47
48
To check the battery charge of the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
To check the battery charge of the Cuff Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Applying ViSi Mobile Monitoring System / Initiate Monitoring . . . . . . . . . . . . . . 50
Applying the ViSi Mobile Wrist Cradle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
To apply the Wrist Cradle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Applying Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Applying the ViSi Mobile Thumb Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
To apply the Thumb Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Applying the ViSi Mobile Chest Sensor Cable and ECG Electrodes . . . . . . . . . . . . 56
Skin Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
3 lead-wire and ECG Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
5 lead-wire and ECG Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
To apply the Chest Sensor Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Applying the ViSi Mobile Cuff Module and Disposable Cuff . . . . . . . . . . . . . . . . . . 61
To apply the Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Removing ViSi Mobile Monitoring System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
To remove Cuff and Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
To remove the Chest Sensor Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
To remove the Thumb Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
To remove the Wrist Cradle and Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Chapter 5. Patient Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Monitoring the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Unlocking the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
To unlock the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Locking the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
To lock the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Viewing Vital Signs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
To view vital signs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Viewing Waveforms Associated with Vital Signs . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
To view the ECG waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
To view other leads with the 5 lead-wire Chest Sensor Cable. . . . . . . . . . . . . . . . . . . . . . . .
To view the RESP waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
To view the SpO2 waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
70
71
73
73
Motion Artifact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Taking a NIBP Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
To take a single NIBP measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
To stop an NIBP measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Initiating Automatic NIBP Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
To initiate automatic NIBP measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Viewing Patient’s Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
To Confirm Patient’s Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
To View Patient’s Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Exchanging a Monitor With Low Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
To exchange a monitor with a low battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Stop Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
To stop monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
To clean and prepare reusable components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
All Sensors Disconnected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Chapter 6. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
System Alarm Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
General Alarm Management Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
In Network Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Physiological Alarms (Alarms) / Technical Alarms (Alerts) Summary . . . . . . . 91
Responding to Alarms/Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Managing Alarm/Alert Annunciations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Responding to Physiological Alarms (Alarms) . . . . . . . . . . . . . . . . . . . . . . . . . . 93
To Silence/Acknowledge Life Threatening Severity Alarms . . . . . . . . . . . . . . . . . . 93
To Silence High Severity Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Responding to Equipment Alarms (Alerts) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
To Silence/Acknowledge Alerts (All Severities) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Managing Alarm Annunciations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Pause / Resume Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
To pause the alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
To Resume Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Turn Alarm Annunciation On / Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
To turn all alarms off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
To Turn On Alarm Annunciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Manage Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
To change alarm limits using Auto Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Testing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Chapter 7. User Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
To clean the ViSi Mobile Monitoring System components . . . . . . . . . . . . . . . . . . . . . . . . . . 111
To disinfect the ViSi Mobile Monitoring System components . . . . . . . . . . . . . . . . . . . . . . . 111
Inspecting Equipment and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Product Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Chapter 8. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
ViSi Mobile Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Screen Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
ViSi Mobile Chest Sensor Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
ViSi Mobile Thumb Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
ViSi Mobile Cuff Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
ViSi Mobile Battery Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
General Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Connectivity Lost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Alarms and Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
ViSi Mobile Remote Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Setting Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Chapter 9. Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Vital Sign Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Heart Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Respiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pulse Oximetry (SpO2, Functional Oxygen Saturation) . . . . . . . . . . . . . . . . . . . . .
Non-Invasive Blood Pressure (NIBP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
126
128
129
131
133
Physical Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
ViSi Mobile Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Wireless Communications / Radio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Mode Plugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
ViSi Mobile Chest Sensor Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ViSi Mobile Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ViSi Mobile Thumb Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ViSi Mobile Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ViSi Mobile Appliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ViSi Mobile Remote Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Customer Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
136
137
138
139
140
141
142
Alarms / Alerts Annunciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Physiological Alarms (Alarms) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Visual Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Audio Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Equipment Alarms (Alerts) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Visual Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Audio Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Environmental Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Agency Compliances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Safety and Performance Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Electromagnetic Compatibility (EMC) Specifications. . . . . . . . . . . . . . . . . . . . . . . 149
Accessories Compliant with EMC Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Recommended Separation Distance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
From Portable and Mobile RF Communication Equipment . . . . . . . . . . . . . . . . . . . . . . . . . 153
Electrosurgery Interference/Defibrillation/Electrostatic Discharge . . . . . . . . . . . . . . . . . . . . 153
Fast Transients/Bursts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Wireless Network Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
Risk Analysis Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
Residual Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
Sotera Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
Responsible Organization Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
Appendix A - Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Alarms / Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Alarm / Alert States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Alarm Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Battery States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
General Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
Navigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vital Signs Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Clinical Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
158
158
158
159
Labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Appendix B - Model Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
ViSi Mobile System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
Appendix C - Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Sotera Wireless Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
- Notes -
1. Preface
1.1 Introduction
This User Manual is intended to provide information for the proper operation of the Sotera Wireless ViSi
Mobile Monitoring System™. A formal knowledge of patient monitoring and an understanding of the
features and functions of the system are prerequisites for its proper use.
This manual is written for trained clinicians. Although this manual describes guidelines for optimizing
monitoring techniques, clinicians using this system should be trained to take and interpret patient vital
signs. Automatic vital signs monitoring is an adjunct to clinical assessment; good clinical judgment should
always prevail.
Do not operate the ViSi Mobile Monitoring System before reading these
instructions.
1.2 Warnings, Cautions and Notes
Please read and adhere to all warnings, cautions and notes listed here and in the associated sections
throughout this manual.
1.2.1 Definitions
Warning statements alert the user to conditions or practices that could result
in injury to a person, or serious adverse events associated with the use or
misuse of the ViSi Mobile Monitoring System.
Caution statements alert the user to conditions or practices that could result
in problems with the ViSi Mobile Monitoring System associated with its use
or misuse.
Note:
Note statements provide supplemental information to the user.
Warnings, Cautions and Notes
Warnings
Intended Use
Do not use the ViSi Mobile Monitoring System outside the intended use described in
this manual. Doing so can result in a delay in or inappropriate therapy.
Do not use the ViSi Mobile Monitoring System in neonatal or pediatric patients under
the age of 12 years since the System has not been tested for these patient groups.
Do not use the ViSi Mobile Monitor as a primary hypoxia diagnostic tool.
Safety
Do not use the ViSi Mobile Monitor in an MRI suite or a hyperbaric chamber.
The ViSi Mobile Monitoring System has not been tested in the presence of electrosurgical devices.
Avoid electrosurgery burns at the ECG monitoring sites by ensuring the electrosurgeryreturn circuit is connected properly.
Monitoring may be temporarily interrupted during the use of electrocautery in the vicinity
of/or on a patient being monitored with a ViSi Mobile Monitoring System. Observe the
patient closely while electrocautery is in use.
To ensure patient safety, use only components and accessories recommended or
supplied by Sotera Wireless, Inc. Accessories must always be used in accordance with
your facility’s policies and the manufacturer’s recommendations.
Use only the AC adapter recommended for the ViSi Mobile Charger. Use of other AC
adapters may result in damage to the unit.
There may be a possible hazard caused by the summation of leakage currents when
several items of equipment are interconnected.
The ViSi Mobile Monitoring System has not been tested in the presence of flammable
anesthetics or other flammable agents in combination with air, nitrous oxide, or oxygenenriched environments.
Route the patient cabling to avoid the possibility of patient entanglement or
strangulation.
To ensure patient safety, the conductive parts of the ECG electrodes, including
connectors and other patient-applied components, should not contact other conductive
parts, or earth ground, at any time.
Never connect the ViSi Mobile Chest Sensor Cable directly to the AC power outlet.
Never connect the ViSi Mobile Cuff Module directly to an AC power outlet. To recharge
the battery, disconnect the Cuff Module from the patient, and then place it in the ViSi
Mobile Charger.
10
Warnings, Cautions and Notes
Warnings
To prevent possible cross-contamination, properly clean and disinfect all reusable
components between patients.
The ViSi Mobile Monitor should never be used to measure the NIBP of one patient while
the Monitor is simultaneously connected to another patient.
Do not attempt to take NIBP measurements with the ViSi Mobile Monitor while the
patient is undergoing cardio-pulmonary bypass.
Do not attempt to take NIBP measurements with the ViSi Mobile Monitor while the
patient is being treated with an intra-aortic balloon pump or left ventricular assist device.
Periodically observe the patient’s arm for signs of impaired circulation, which may be a
result of measurements made too frequently. Loosen or remove the ViSi Mobile
Disposable Cuff if signs and/or symptoms of prolonged impaired circulation are evident.
Never place the ViSi Mobile Monitor or the ViSi Mobile Cuff Module into the ViSi Mobile
Charger while connected to a patient.
Never connect the ViSi Mobile Monitor directly to an AC power outlet. To recharge the
battery, disconnect the Monitor from the patient, and then place it in the ViSi Mobile
Charger.
Do not clean the ViSi Mobile Monitor with detergents while worn by the patient.
Do not place the ViSi Mobile Monitoring System on or over an implanted programmable
medical device.
Disposable Patient Kit
All components of the ViSi Mobile Patient Kit are for single patient use only. To avoid
possible cross contamination, do not reuse any of the items from the Patient Kit on a
patient other than the original patient. Dispose of the ViSi Mobile Patient Kit items after
use per your facility’s policy.
All disposable components of the ViSi Mobile Monitoring System are for single patient
use only. To avoid possible cross contamination, do not reuse any disposable items on
a patient other than the original patient.
Patient Monitoring
Do not connect more than one ViSi Mobile Monitor to a patient.
Do not connect more than one patient to a single ViSi Mobile Monitor.
The ViSi Mobile Monitor, Thumb Sensor, Cuff Module, and the Chest Sensor Cable
must all be connected to the same arm for the System to function correctly.
11
Warnings, Cautions and Notes
Warnings
The Wrist Strap should securely hold the ViSi Mobile Wrist Cradle in place without
impairing circulation. Immediately loosen the Wrist Strap if the patient complains of
pain, tingling, or numbness in the affected hand or wrist.
Only use the ViSi Mobile Chest Sensor Cable provided by Sotera Wireless, Inc. for the
ViSi Mobile Monitoring System. The Chest Sensor Cable is designed to provide
defibrillation protection as indicated in the Specifications section of this manual. ViSi
Mobile is designed to be compatible with the use of external defibrillators.
Only use the ViSi Mobile Thumb Sensor provided by Sotera Wireless, Inc. with the ViSi
Mobile Monitoring System.
The ViSi Mobile Thumb Sensor is intended for use on the patient’s thumb only. Do not
apply the Thumb Sensor to the patient’s fingers.
Inspect patient’s skin at sensor site every 8 hours. If skin surface has been
compromised, reposition the ViSi Mobile Thumb Sensor or move the Thumb Sensor to
the patient’s other thumb.
The Thumb Strap should securely hold the ViSi Mobile Thumb Sensor in place without
impairing circulation. Immediately loosen the Thumb Strap if the patient complains of
pain, tingling, or numbness in the affected thumb.
Only Sotera Wireless, Inc. supplied ViSi Mobile Thumb Sensors should be used. Using
non-approved Thumb Sensors may result in inaccurate SpO2 readings.
Before monitoring a new patient, ensure all the sensors have been removed and that
monitoring was stopped using the Stop Monitoring procedure.
To prevent settings from being inadvertently changed, lock the ViSi Mobile Monitor
screen (if enabled) as soon as tasks are completed.
Keep all pacemaker patients under close or constant observation. Pacemaker signals
can differ among pacemakers, ICDs, or CRT devices. The Association for the
Advancement of Medical Instrumentation (AAMI) cautions: “In some devices, rate
meters may continue to count the pacemaker rate during occurrences of cardiac arrest
or some arrhythmias. Do not rely entirely upon rate meter alarms”.
Other RF radiating devices (such as high powered RFID readers and Bluetooth
devices) that are in close proximity with the ViSi Mobile Monitor may interfer with the
Monitor’s wireless communications. During such interference, the Monitor continues to
monitor and will alarm locally. If wireless communication is affected when using the
Monitor in close proximity with another RF radiating device, move the other device
away from the Monitor or discontinue use of the other device.
12
Warnings, Cautions and Notes
Warnings
All wireless devices are susceptible to radio frequency interference that can disrupt
connectivity. If you observe excessive ViSi Mobile Monitoring System disconnections,
notify your biomedical engineer. Excessive disconnections can cause interrupted
patient monitoring; disconnections must be investigated and corrected.
Locate the ViSi Mobile Remote Viewer so that clinicians can view it without obstruction.
Remove any objects that obstruct the display.
A qualified clinician must always be in direct view of the ViSi Mobile Remote Viewer. If
the Remote Viewer display is blank, contact your Bio Med immediately for service.
If a ViSi Mobile Monitor or the ViSi Mobile Remote Viewer display screen is scratched
or damaged, immediately send it for servicing. A scratched or damaged screen can
interfere with patient monitoring.
Always consult Sotera Wireless before performing any changes to the ViSi Mobile
Appliance. Server changes can result in communication failure between
components of the ViSi Mobile Monitoring System. If system communication
stops, monitor patients at the ViSi Mobile Monitors.
Perform a risk assessment and verification before you implement a change or
modification to the IT infrastructure. Changes to IT network configurations can
compromise continuous vital signs monitoring and alarm delivery.
Vital Signs
If a vital signs measurement is questionable, retake the measurement. If the result is
still questionable, use a different method of measurement.
Chest Sensor Cable: ECG, Respiration, Temperature (Skin)
Use all of the same type of ECG electrodes on the patient. Mixing ECG electrode types
can adversely affect ECG monitoring.
If ECG electrodes need to be replaced, use all of the same type of ECG electrode on
the patient. Mixing ECG electrode types can adversely affect ECG monitoring.
Avoid placing the ViSi Mobile Cable Securement and ECG electrodes over areas of
abrasions, irritation, or other sensitive areas. If possible, remove, reposition, and
replace ECG electrodes and Cable Securement if the patient complains of pain/itching
at the sites.
13
Warnings, Cautions and Notes
Warnings
The ViSi Mobile Monitor does not provide automated arrhythmia analysis. As a result,
certain arrhythmias may cause the Monitor to display inaccurate heart rates. If frequent
arrhythmias are suspected, their presence should be confirmed by another method,
such as a 12-lead ECG or Holter monitoring.
The ViSi Mobile Monitor does not have automated ST segment analysis, therefore, if a
change in the ST segment of the ECG waveform is suspected, it should be confirmed
by another method, such as a 12-lead ECG.
Pacemaker signals can differ among pacemakers, ICDs, or CRT devices. The
Association for the Advancement of Medical Instrumentation (AAMI) cautions: “In some
devices, rate meters may continue to count the pacemaker rate during occurrences of
cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms”. All
pacemaker patients should be kept under close or constant observation.
External pacemakers or other external electrical stimulators may cause the ViSi Mobile
Monitor to produce erroneous results.
RESP (chest wall motion) can continue in the absence of ventilation (obstructed
airway). Do not rely on the RESP alone to determine adequacy of ventilation. Other
vital signs, such as HR and SpO2, should be assessed as well.
TEMP monitoring with the ViSi Mobile Monitoring System is intended for trending
purposes only and is not intended to replace core temperature monitoring. Before
making clinical decisions based on the skin temperature measurement, verify the
measurement using another clinically acceptable method of core temperature
measurement.
Impedance pneumography for the determination of respiration (RESP) is not
recommended for use in the presence of mechanically induced, high frequency
ventilation.
Cuff Module / NIBP
ViSi Mobile Disposable Cuffs are for single patient use only. To avoid possible cross
contamination, do not reuse a Cuff on a patient other than the original patient.
The ViSi Mobile Disposable Cuff should be snug enough to support the Cuff Module
while not impairing circulation when deflated.
Avoid applying the ViSi Mobile Disposable Cuff over a wound as this can cause further
injury.
Avoid applying the ViSi Mobile Disposable Cuff on any limb where intravascular access
or therapy, or an arterio-venous (A-V) shunt, is present because of temporary
interference to blood flow which could result in injury to the patient.
14
Warnings, Cautions and Notes
Warnings
Take care in the application of the ViSi Mobile Disposable Cuff when applying the Cuff
to an arm on the same side of a mastectomy.
ViSi Mobile NIBP measurements have not been clinically tested in the presence of
actual or ventricular arrhythmias. Use alternative BP methods if these arrythmias are
present.
Inflate the ViSi Mobile Disposable Cuff only after proper application to the patient’s limb.
If you are uncertain of the reliability of an NIBP measurement, repeat the measurement.
If the reading is still suspect, use another method to measure the blood pressure.
SpO2
Oxygen saturation measurements using SpO2 are dependent on proper sensor
placement, exposure to ambient light conditions, and general patient conditions. Before
making clinical decisions based on SpO2 measurements, verify the measurement using
another clinically acceptable method, such as arterial blood gas analysis.
High ambient light condition, including direct sunlight, may interfer with the performance
of the ViSi Mobile Thumb Sensor.
Low perfusion, electro-surgical devices, dysfunctional haemoglobin, the presence of
certain dyes and inappropriate positioning of the ViSi Mobile Thumb Sensor may result
in erroneous measurements.
Alarms / Alerts
When using the Monitor as a standalone device or the patient is out of network range, a
responsible clinician must be within audible range of the assigned patient wearing the
ViSi Mobile Monitor at all times.
When alarms are paused, there is no notification of a potentially clinically significant
change in the patient's vital signs. Observe the patient by other means when alarms are
paused.
When alarms are turned OFF, there is no notification of a potentially clinically significant
change in the patient's vital signs. Observe the patient by other means when alarm
limits are set to OFF.
Once new alarm limits are confirmed, they cannot be changed back to the original preset limits. Once Auto Set is selected, review the newly calculated alarm limits carefully
before deciding to confirm or cancel the new alarm limits.
15
Warnings, Cautions and Notes
Warnings
Line isolation monitor transients may resemble actual cardiac waveforms and inhibit
heart rate alarms. Ensure correct electrode placement and cable arrangement to
minimize line isolation monitor transients.
To avoid possible hearing damage, do not place your ear too close to the ViSi Mobile
Monitor that is alarming audibly.
When the ViSi Mobile Monitor alarms or alerts, check the patient first to confirm that
there is no immediate danger to the patient.
If you test the speaker at the ViSi Mobile Remote Viewer and the tone does not sound
or it is not loud enough, immediately contact a biomedical engineer. The test indicates
how alarm and alert tones sound at the Remote Viewer. If the sound is inadequate,
clinicians could miss alarms and alerts.
User Maintenance
To avoid contaminating or infecting personnel, the environment or other equipment,
make sure you disinfect and decontaminate the ViSi Mobile Monitoring System
components appropriately before disposing of them in accordance with your country’s
laws for equipment containing electrical and electronic parts.
Wireless Communications
When the ViSi Mobile Monitor is not configured or loses wireless connection to the ViSi
Mobile Appliance, the ViSi Mobile Remote Viewer does not receive patient alarms or
alerts from the ViSi Mobile Monitor.
If you have any concerns regarding a Cybersecurity breach or vulnerability, contact
Sotera Wireless or an authorized Sotera Wireless representative in your area.
Off-The-Shelf (OTS) Software
The use of any software other than those specified in this manual will violate the safety,
effectiveness and design controls of this medical device and such use may result in an
increased risk to users and patients. Customer installed virus protection software will
be permitted on the ViSi Mobile Remote Viewer but not permitted on the ViSi Mobile
Appliance.
16
Warnings, Cautions and Notes
Cautions
Intended Use
Federal (U.S.A.) law restricts the ViSi Mobile Monitoring System to the sale, distribution,
or use by, or on the order of a licensed medical practitioner.
Safety
The ViSi Mobile Monitoring System has not been tested in the presence of flammable
anesthetics or other flammable agents in combination with air, nitrous oxide, or oxygenenriched environments.
Do not use a ViSi Mobile Monitor, its components, or accessories that appear
damaged. Inspect all reusable components for damage before each use.
Do not attempt to connect any patient worn component, ViSi Chest Sensor Cable or
ViSi Mobile Cuff Module to an electrical outlet of any kind.
A component that has been dropped or severely abused should be checked by qualified
service personnel before use on a patient.
The ViSi Mobile Monitoring System is not indended for home use.
Do not use the ViSi Mobile Monitoring System to monitor a patient in a wet
environment, such as a shower.
Explosion Hazard. Do not use in the presence of a flammable anesthetic mixture with
air, or with oxygen or nitrous oxide.
Use care when using automatic cuff inflation for prolonged periods on unconscious or
semi-conscious patients since the patient may not be able to alert the clinician to any
pain he/she may be experiencing. Pressing the “Stop NIBP” button interrupts the NIBP
measurement and deflates the cuff.
Consult your BioMed department or vendors for assistance in identifying EMC
compliance status of other medical devices when using the ViSi Mobile Monitoring
System.
Using accessories other than those specified may result in increased electromagnetic
emission or decreased electromagnetic immunity of the monitoring equipment.
Service / Maintenance
If the ViSi Mobile Monitor detects an unrecoverable problem, an error message
containing the error number is displayed. Remove the Monitor from use and report the
error to Sotera Wireless, Inc.
When the ViSi Mobile Monitor is in the Charger and a charging alert occurs, remove the
Monitor from service.
17
Warnings, Cautions and Notes
Cautions
General maintenance of the ViSi Mobile Monitoring System should be conducted at the
prescribed intervals.
The ViSi Mobile Monitoring System components should only be serviced by Sotera
Wireless, Inc. technicians or authorized service providers.
Equipment / Components
If the ViSi Mobile Monitor is to be stored for an extended period of time, it is
recommended the Monitor be stored with the Shipping Plug inserted to reduce the
battery discharge. The ViSi Mobile Monitor must always have the Shipping Plug
inserted when shipped by a common carrier to comply with Federal Regulations
regarding electromagnetic emissions.
When inserting the ViSi Mobile Monitor into the Wrist Cradle, ensure proper alignment:
flat end to flat end and the round end is pointing down towards the wrist.
Selection of the correct ViSi Mobile Disposable Cuff size is necessary to ensure
accurate NIBP measurements. A Cuff that is too small can result in a falsely high NIBP
measurement. A Cuff that is too large can result in a falsely low NIBP measurement.
To avoid damage from dropping the ViSi Mobile Monitor, ensure that the Wrist Strap is
snugly wrapped around the wrist.
To avoid damage from dropping the ViSi Mobile Monitor, make sure that the Monitor is
securely snapped into the ViSi Mobile Wrist Cradle.
The ViSi Mobile Monitoring System does not support printing capability.
The performance of the automated sphygmomanometer may be affected by extremes
of temperature, humidity and altitude.
The ViSi Mobile Monitor may not perform to specification if stored or shipped outside
the specified temperature range.
The ViSi Mobile Monitor may be temporarily interrupted by UHF RFID Systems (860960MHz).
Cleaning / Disinfecting
Do not clean the ViSi Mobile Monitor while it is plugged into the ViSi Mobile Charger.
Do not clean the ViSi Mobile Cuff Module while it is plugged into the ViSi Mobile
Charger.
Do not apply liquid to the ViSi Mobile Cuff Module. To clean, use a damp cloth.
18
Warnings, Cautions and Notes
Cautions
Ensure the sensor connector contacts are thoroughly dried to prevent possible
malfunction.
Thumb sensors which are saturated with fluid should be allowed to air dry thoroughly
before re-use.
Do not use abrasive cleaning agents or organic solvents on any of the ViSi Mobile
Monitoring System components.
Use only recommended cleaning / disinfecting agents to prevent damage to the device
and components.
Do not autoclave the ViSi Mobile Monitor, its components, or accessories.
Do not use excessive amounts of liquid when cleaning the ViSi Mobile Chest Sensor
Cable or the ViSi Mobile Thumb Sensor.
After patient use, the disposables from the ViSi Patient Kit may contain bio-hazard
materials.
When the ViSi Mobile Cuff Module is connected to the other ViSi Mobile Components,
the entire system has an ingress protection rating of IPX0.
Notes
Note: Figures in this manual are provided for reference purposes only. Screens may differ based on
the monitoring device configuration, licenses available, parameters selected and patient
configuration of the ViSi Mobile Monitoring System.
Note: All ViSi Mobile Monitoring System alarms and alerts annunciate with icons and colors that
comply with IEC 60601-1-8.
19
Intended Use
1.3 Intended Use
The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for
single or multi-parameter vital signs monitoring of adult patients. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), non-invasive
monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin
temperature (TEMP) in hospital-based facilities; including general medical-surgical floors, intermediatecare floors, and emergency departments.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to a Remote Viewer
through wireless 802.11 communication.
1.3.1 Contraindications
•
•
•
•
•
•
•
20
Impedance pneumography for the determination of Respiration Rate (RESP) is not recommended
for use in the presence of mechanically induced high frequency ventilation.
The ViSi Mobile Monitoring System has not been tested for use on neonatal or pediatric patients
under the age of 12 years.
Do not use the same ViSi Mobile Monitor System to measure the NIBP of one patient while it is
connected simultaneously to another patient.
Do not use the ViSi Mobile Monitor on a patient with an Intra-Aortic Balloon Pump (IABP), or a
Left Ventricular Assist Device (LVAD). The Monitor requires an unperturbed arterial pulse
waveform for non-invasive blood pressure calculations. IABP and LVAD perturb the arterial pulse
waveform.
Do not use the ViSi Mobile Monitor System on a patient on cardio-pulmonary bypass.
Do not use the ViSi Mobile Cuff Module on a patient’s arm where the use of a blood pressure cuff
is contraindicated.
Do not use the ViSi Mobile Monitoring System in an MRI Suite.
2. General Description
2.1 Introduction
The ViSi Mobile Monitoring System is a patient worn, portable, battery operated, physiological
monitoring device indicated for the monitoring of ECG (3 lead-wire or 5 lead-wire), Heart Rate (HR),
Pulse Rate (PR), Respiration (RESP), Non-Invasive Blood Pressure (NIBP), Pulse Oximetry (SpO2), and
Skin Temperature (TEMP).
The System comprises the ViSi Mobile Monitor, Thumb Sensor, Chest Sensor Cable (either 3 lead-wire or
5 lead-wire), Cuff Module, Charger and Patient Kit.
Powered by a rechargeable battery lasting at least 12 hours, the Monitor is a lightweight (weighing
approximately 125 grams) portable patient vital signs monitor featuring a high resolution, full color
display touchscreen with visual and audible alarms and alerts.
For ease of use, the Monitor features three interchangeable plug-in sites for the Chest Sensor Cable and
Cuff Module.
The industry-standard technique of oscillometry is used for non-invasively taking single measurements of
the systolic and diastolic blood pressure (NIBP) as well as pulse rate. The method is based on the
observation of oscillations in the sphygmomanometer cuff pressure that are caused by the oscillations of
blood flow, i.e., the pulse in the patient’s upper arm. It uses a sphygmomanometer cuff like the auscultatory
method, but with an electronic pressure sensor (transducer) to observe cuff pressure oscillations,
electronics to automatically interpret them, and automatic inflation and deflation of the Cuff. The Cuff
Module measures on inflation. The measurement is realized by a Cuff, to which the Cuff Module is
attached (pneumatic connection). The electric connection to the Monitor is established through a cable that
connects to its upper side.
21
Unpacking
2.2 Unpacking
Remove the Monitor and associated components from the shipping cartons and examine them for signs of
shipping damage. Save all packing materials, invoice, and bill of lading. These may be required to process
a claim with the carrier. Check all materials against the packing list. Contact the Sotera Wireless Inc.
Customer Service Department or the Sotera Wireless representative in your area for prompt assistance in
resolving shipping problems.
2.2.1 Removing and Inserting the Shipping Plug
All Monitors are shipped in the Wrist Cradle with a Shipping Plug (airplane symbol) inserted. This Plug is
found in the Thumb Sensor connector of the Monitor. The Shipping Plug’s only function is to completely
power off the Monitor. Reinserting the Plug into a Monitor powers down the Monitor in a controlled
fashion, and allows internal operations to be completed before completely powering off.
Shipping Plug
(with airplane symbol)
To remove the Shipping Plug
Grasp the tip of the Plug that extends out from the Wrist Cradle and pull firmly outward.
The contact points are disconnected. The Monitor begins a power up phase and the initial
information screen appears.
To insert the Shipping Plug
Ensure that the ViSi Mobile Monitor is properly seated in the Wrist Cradle, the Plug is oriented
with the connector contacts facing upwards, and push in firmly.
The power down process begins. The power down cycle is complete once the screen goes blank
and the green LED indicator has stopped blinking
If the ViSi Mobile Monitor is to be stored for an extended period of time, it is
recommended the Monitor be stored with the Shipping Plug inserted to
reduce the battery discharge. The ViSi Mobile Monitor must always have
the Shipping Plug inserted when shipped on a common carrier to comply
with Federal Regulations regarding electromagnetic emission.
22
System Components
2.3 System Components
2.3.1 ViSi Mobile Patient Kit
The Patient Kit contains the disposable components of the system. The Patient Kit components are for
single patient use only. The Patient Kits are available in three Adult sizes: Small, Medium, and Large.
Choose the Patient Kit that contains the Cuff size best suited for the patient. Cuff sizes follow standard
range of arm circumference. See 4.2.5Selecting the ViSi Mobile Patient Kit on page 47.
All components of the ViSi Mobile Patient Kit are for single patient use only.
To avoid possible cross contamination, do not reuse any of the items from
the Patient Kit on a patient other than the original patient. Dispose of the
ViSi Mobile Patient Kit items after use per your facility’s policy.
ViSi Mobile Patient Kit Contents
Equipment
Quantity
ViSi Mobile Disposable Cuff
(with pneumatic connector)
ECG Electrode
ViSi Mobile Wrist Cradle
ViSi Mobile Thumb Cradle
ViSi Mobile Setup Guide
ViSi Mobile Cable Securement
23
System Components
ViSi Mobile Disposable Cuff
The Cuff is available in small, medium and large adult sizes (see 4.2.5Selecting the ViSi Mobile Patient
Kit on page 47). The Cuff is used to take a NIBP measurement once the Cuff Module is plugged in. See
ViSi Mobile Cuff Module on page 28.
Cuff Module
Attachment
Artery
Reference Line
Note: Only cuffs designed for use with the ViSi Mobile Cuff Module may be used.
ECG Electrode
ECG Electrodes are adhesive pads with conductive gel that are connected to the ECG lead-wires of the
Chest Sensor Cable to display the ECG waveform and detect the HR. Use only snap-on type electrodes.
24
System Components
ViSi Mobile Wrist Cradle
The Wrist Cradle holds the Monitor and provides the electrical connectors for the sensors. The Wrist
Cradle is held in place on the patient’s wrist with a strap. The Wrist Cradle Strap is available in small,
medium and large adult sizes.
Flat End
Wrist Cradle Strap
Round End
When inserting the ViSi Mobile Monitor into the Wrist Cradle, ensure proper
alignment: flat end to flat end and the round end is pointing towards the
wrist.
ViSi Mobile Thumb Cradle
The Thumb Cradle holds the Thumb Sensor and secures it to the base of the thumb.
Thumb Cradle
Thumb
Strap
Bottom View
(with labelling)
Top View
25
System Components
ViSi Mobile Cable Securement
There is one large and one small Cable Securement in the Patient Kit. The large Cable Securement secures
the Chest Module of the Chest Sensor Cable to the patient’s torso. The small Cable Securement secures the
Upper Arm Module of the Chest Sensor Cable to the upper arm. See ViSi Mobile Chest Sensor Cable on
page 29.
Chest Module
Securement
Packaging
Upper Arm Module
Securement
2.3.2 ViSi Mobile Monitor
The Monitor is a compact and lightweight device that is worn on the patient’s wrist. The Monitor is held in
place by the Wrist Cradle, which allows sensors to be connected. The Monitor can be removed from the
Wrist Cradle in order to charge, or swap for another Monitor. The Monitor uses a touchscreen user
interface to access the displays and monitoring functions.
Touchscreen
3 Interchangeable
Sensor Connections
Microphone
(for speaker self test)
Power
Indicator
Speaker
Note: The power indicator shows the level of Monitor’s battery charge by flashing green (the
battery has at least 2 hours of monitoring time left), yellow (the battery is low with less than
2 hours of monitoring time left), and red (the battery is critically low with less than 30
minutes of monitoring time left).
26
System Components
2.3.3 ViSi Mobile Thumb Sensor (SpO2)
The Thumb Sensor is applied to the patient’s thumb with the sensor and sensor cradle facing the patient’s
palm. The Thumb Sensor is plugged into the rounded end of the Wrist Cradle with the connector contacts
facing upwards.
Insert with connector
contacts facing upwards
Note: The Thumb Sensor locks the ViSi Mobile Monitor into the Wrist Cradle and must be
unplugged to remove the Monitor from the Wrist Cradle.
Note: A Locking Plug should be used to lock the Monitor into the Wrist Cradle if the Thumb
Sensor is not used. Locking Plugs may be ordered separately from Sotera Wireless.
27
System Components
2.3.4 ViSi Mobile Cuff Module
The Cuff Module is used to take NIBP measurements. The Cuff Module plugs into any one of the
connectors on the flat end of the Wrist Cradle.
Battery Status
Indicator (LEDs)
Battery Status
Button
Note: When the battery status button is pressed, the battery status indicator shows the level of the
Cuff Module’s battery charge. Green lights indicate the battery has a minimum of 11%
charge. More green lights indicate a greater charge level. A yellow light indicates the
battery charge is less than 10%. A red light indicates there is less than 4% battery charge.
Note: When a calibration check is required, return the Cuff Module to the Bio Med.
recommended a calibration check is performed ever year.
28
It is
System Components
2.3.5 ViSi Mobile Chest Sensor Cable
The Chest Sensor Cable is either a 3 lead-wire or 5 lead-wire and plugs into any one of the connectors on
the flat end of the Wrist Cradle. See Applying the ViSi Mobile Chest Sensor Cable and ECG Electrodes on
page 56 for recommended Chest Sensor Cable placement.
The ViSi Mobile Chest Sensor Cable is designed to be fully compatible with
external defibrillators. No additional precautions are required.
Chest Module
(including Skin Temperature Sensor
on the reverse side)
Upper Arm Module
Monitor
Connector
Lead
Wires
Front View
(Place this side away from the patient’s skin)
Chest Sensor Cable
5 Lead
Chest Sensor Cable
3 Lead
29
System Components
2.3.6 ViSi Mobile Charger
The Charger is used to charge both Monitors and Cuff Modules, providing eight charging docks for
simultaneously charging multiple units.
The Charger consists of a desktop/wall mount charger, power supply and power cable.
Front View
Back View
To set up the Charger
1. Connect the power cable to the back side of the desktop/wall mount charger.
2. Plug into the AC power outlet.
The light on the front of the Charger will display green when the Charger is connected to the AC
power outlet.
The Charger will beep once when it is connected to the AC power outlet.
Note: When connected to the AC power outlet, if a fault with the ViSi Mobile Charger is detected,
the Charger will audibly beep every second.
Explosion Hazard. Do not use in the presence of a flammable anesthetic
mixture with air, or with oxygen or nitrous oxide.
30
System Components
2.3.7 Charging the ViSi Mobile Monitor and Cuff Module
The ViSi Mobile Charger provided by Sotera Wireless, Inc. is the required Charger for both the Monitor
and the Cuff Module. The Charger is capable of charging up to eight of any combination of Monitors and
Cuff Modules. To charge either the Monitor or the Cuff Module place the flat end into one of the slots with
the front facing outwards.
Note: The ViSi Mobile Charger is to be used for ViSi Mobile components only.
Note: ViSi Mobile Monitors and Cuff Modules contain sealed batteries that are not replacable by
the user. If a Monitor or Cuff Module has a battery issue, contact the Sotera Wireless Inc.
Customer Service Department or the Sotera Wireless representative in your area.
The LED on the Charger is used to indicate the charging status of devices that are currently inserted:
LED Color
Charging Status
Steady Green
Everything is normal:
• No devices in the Charger.
• All devices are charging normally or are fully charged.
Flashing Green /
Yellow
At least one device in the Charger is in battery recovery mode with the device not
talking to the Charger.
Steady Yellow
At least one device in the Charger is not being charged due to a fault with the device.
The other devices are charging.
Steady Red
Charger fault. No devices are charging, the Charger has shutdown.
31
System Components
To charge a Monitor
Insert the Monitor that you want to charge into one of the Charger docks.
When the ViSi Mobile Monitor is in the Charger and a charging alert occurs,
remove the Monitor from service.
The Charge Status screen will be displayed briefly. The Monitor’s battery status indicator (in the top right
hand of the screen) stops pulsating when the battery is fully charged
Battery Charging Indicator
(pulsates as battery is charging)
RESP measurement
option is available
Battery Status
Indicator
In Charger
Note: When the yellow dot is displayed on the screen, it indicates the Monitor will measure RESP
when a Chest Sensor is connected to a patient. RESP is not available as part of the default
set of vital sign measurements and must be purchased separately.
Note: If the screen is blank, touch the screen to activate the display and show the battery charge
status.
Power
Indicator
The power indicator will blink while the Monitor is charging: green indicates there is enough charge to
monitor a patient for at least two hours; yellow indicates the battery charge is low (less than two hours of
monitoring); and red indicates the battery charge is critically low (less than 30 minutes of monitoring).
32
System Components
To charge a Cuff Module
Insert the Cuff Module that you want to charge into one of the Charger docks.
One of the charging indicator lights will blink while the Cuff Module is charging.
Battery is empty
(Red LED)
Battery is low
(Yellow LED)
Battery is fully charged
When one of the green charging indicators is flashing, the battery in the Cuff Module is charging. The
position of the green charging indicator represents the level of charge. When the charge indicator furthest
away from the red charging indicator is flashing, the Cuff Module is fully charged.
When the yellow charging indicator is flashing, the battery in the Cuff Module is low. No more than a
couple of cuff inflations are possible.
When the red charging indicator is flashing, the battery in the Cuff Module is empty. No cuff inflations are
possible.
33
System Components
- Notes -
34
3. Clinical Features
3.1 Introduction
The ViSi Mobile Monitor is completely body-worn and designed to continuously measure ECG/HR, SpO2,
PR, RESP, and TEMP. The ECG, SpO2, and RESP waveforms are viewable on demand. NIBP can be
measured as a one-time measurement, or it can be measured automatically at predefined intervals.
The Chest Sensor Cable measures the ECG/HR, RESP, and TEMP. The illustration on the next page shows
a 3 lead-wire placement.
35
36
Monitor
(in Wrist Cradle)
Arterial
Reference Line
Cuff Module
Upper Arm Module
(Chest Sensor Cable)
Upper Arm Module
Securement
(Flat End)
ViSi Mobile Monitoring System Setup
(Round End)
Thumb
Sensor
Temperature Probe
(Place against patient’s skin)
Front
(Place away from patient’s skin)
(Cables pointing down)
(Chest Sensor Cable)
Chest Module
Securement
Chest Module
Introduction
Key Features
3.2 Key Features
•
•
•
•
•
Battery life > 12 hours
Full charge reached after approximately 2 hours of charging
Chest Sensor Cable options: 3 lead-wire and 5 lead-wire (HR and ECG waveforms)
RESP (measurement and waveform)
SpO2% (measurement and waveform)
•
•
•
•
•
TEMP (oC/oF) (Skin Temperature measurement)
NIBP (single measurement and automatic measurements at predefined cycles)
Touchscreen display
Alarms and Alerts generated with visual and audible indication on the Monitor
Self Test
3.3 Overview of Clinical Features
The ViSi Mobile Monitoring System is a lightweight portable patient vital signs monitor featuring a high
resolution, full color display with visual and audible alarms and alerts. The ViSi Mobile Monitor is
completely body-worn and designed to continuously measure ECG/HR, SpO2, PR, RESP, and TEMP.
ECG, SpO2, and RESP waveforms are viewable on demand. NIBP can be measured as a one-time
measurement, or it can be measured automatically at programmed intervals.
The Monitor is powered by a rechargeable battery. For ease of use, the Monitor features interchangeable
plug-in sites for the ViSi Mobile Chest Sensor Cable and ViSi Mobile Cuff Module. The Chest Sensor
Cable measures the ECG/HR (with a 3 lead-wire or 5 lead-wire), RESP, and TEMP.
3.3.1 ECG Monitoring and Heart Rate (HR) Monitoring
With the 3 lead-wire Chest Sensor Cable, the Monitor continuously monitors Lead II.
With the 5 lead-wire Chest Sensor Cable, the Monitor continuously monitors seven ECG lead views
simultaneously, Leads I, II, III, aVR, aVL, aVF, and a V lead. The ECG waveform can be displayed one
lead at a time.
The ability to monitor multiple leads simultaneously improves beat detection to determine the HR and
minimizes false detections as a result of muscle artifact.
3.3.2 Respiration Rate (RESP) Monitoring
RESP is determined by measuring the AC impedance between the RA and LL ECG electrodes. Chest wall
motion, rise and fall, associated with inspiration and expiration is automatically detected when the RA and
LL leads are placed in the standard Lead II configuration on the chest, or in the MCL configuration.
37
Overview of Clinical Features
RESP is determined from the frequency of the respiration (chest wall motion). The respiration channel can
detect the absence of RESP.
RESP (chest wall motion) can continue in the absence of ventilation
(obstructed airway). Do not rely on the RESP alone to determine adequacy
of ventilation; other vital signs such as HR and SpO2 should be assessed as
well.
3.3.3 Skin Temperature (TEMP) Monitoring
TEMP is continuously measured skin surface temperature as measured by the probe located on the
underside of the Chest Module. The probe must be placed directly in contact with the patient’s skin.
TEMP can be displayed in °C or °F. See To apply the Chest Sensor Cable on page 59.
Note: Skin temperature may not be the same as core body temperature or temperature measured
from oral or tympanic methods.
Note: Skin temperature representative of skin surface temperature will take approximately 6
minutes from the time the Chest Module is applied.
TEMP monitoring with the ViSi Mobile Monitoring System is intended for
trending purposes only and is not intended to replace core temperature
monitoring. Before implementing therapy based on the skin temperature
measurement, verify the measurement using another clinically acceptable
method of core temperature measurement.
3.3.4 Pulse Oximetry (SpO2 and Pulse Rate) Monitoring
The Pulse Oximetry channel non-invasively continuously measures the functional oxygen saturation of the
hemoglobin in arterial blood using the transmittance across the base of the thumb. A pulsatile arterial
source at the base of the thumb is required to measure the SpO2.
In the absence of a HR source from an ECG, the Pulse Rate (PR) can be measured and displayed from the
SpO2 channel.
Oxygen saturation measurements using SpO2 are dependent on proper
sensor placement, exposure to ambient light conditions, and general patient
conditions. Before making clinical decisions based on SpO2 measurements,
verify the measurement using another clinically acceptable method, such as
arterial blood gas analysis.
High ambient light condition, including direct sunlight, may interfer with the
performance of the ViSi Mobile Thumb Sensor.
Low perfusion, electro-surgical devices, dysfunctional haemoglobin, the
presence of certain dyes and inappropriate positioning of the ViSi Mobile
Thumb Sensor may result in erroneous measurements.
38
Display Screens
3.3.5 NIBP Monitoring
The ViSi Mobile Cuff Module is intended for measuring arterial blood pressure (systolic and diastolic)
using a Cuff. Measurements may be initiated manually (one at a time), or automatically at selectable
predefined intervals of 5, 10, 15, 30, 60, 90 and 120 minutes.
The accuracy of NIBP measurements is influenced by several factors:
•
•
•
•
Correct cuff size
Correct cuff placement on the arm
The position of the upper arm in relation to the heart at the time of the measurement
Motion artifacts
3.4 Display Screens
This section describes various screens displayed on the ViSi Mobile Monitor. Each screen is accessed by
interacting with the touchscreen display.
3.4.1 Battery Charge Screen
The Battery Charge screen displays the battery status while the Monitor is charging in the Charger.
Battery Charging Indicator
(pulsates as battery is charging)
RESP measurement
option is available
Battery Status
Indicator
Note: When the yellow dot is displayed on the screen, it indicates the Monitor will measure RESP
when a Chest Sensor is connected to a patient. RESP is not available as part of the default
set of vital sign measurements and must be purchased separately.
39
Display Screens
3.4.2 Hibernation Screen
The Hibernation screen (blank screen) is the default when no monitoring is currently in progress.
Power
Indicator
The Hibernation screen conserves battery power under the following conditions:
•
•
•
The Shipping Plug is not plugged into the Monitor
The Monitor is not in the Charger
No sensors are connected to the Monitor
Note: When in Hibernation, the power indicator blinks approximately every 9 seconds. The power
indicator color is reflective of the battery status: “Green” indicates there is sufficient battery
charge for at least two hours of monitoring; “Yellow” indicates the battery charge is depleted
and there is less than 2 hours of monitoring available; and “Red” indicates the battery
charge is depleted and there is less than 30 minutes of monitoring available. When the
power indicator stops blinking, the battery charge is empty.
Note: Connecting a sensor to the Monitor displays the Vital Sign screen. There will be a brief delay
before the Vital Sign screen is displayed to allow the Monitor’s self test to complete.
40
Display Screens
3.4.3 Vital Signs Screen
The Vital Signs screen is the default screen that displays automatically (on initial setup) when sensors are
placed on the patient and connected to the Monitor.
Start/Stop
NIBP
Message area
(Patient’s Primary Id)
RESP
Battery Status
Indicator
Pause
Menu
HR/PR
Alarm
Management
Turn Off
Sp02
Turn On
Resume
NIBP
Alarm Status
Lock
TEMP
Alarm
in progress
Alarms
Off
Alert
In progress
Alarms
Alarm
Paused Acknowledged
Use the Vital Signs screen to:
•
•
•
•
•
•
•
•
•
View current vital sign measurements
Vital Signs Measurement: Access the waveforms (see page 70)
Alarm Status: View alarm status
Battery Status Indicator: View the battery status
Menu: Access the Menu screen (see page 42)
Start/Stop NIBP: Start and stop manual NIBP measurement (see page 75)
Alarm Management: Pause alarms/alerts (see page 99)
Alarm Management: Acknowledge (silence) alarms/alerts (see pages 93 and 97)
Lock: Lock the Monitor to prevent unauthorized access
41
Display Screens
3.4.4 Menu Screen
Touch Menu on the Vital Sign screen to view the Menu screen.
Stop Monitoring
Monitor Status
NIBP Inflation Settings
(Manual/Auto)
Alarm
Management
QRS/PR
Beep Tone On/Off
Beep On
Beep Off
Return to Previous
Screen
Use the Menu screen to:
•
•
•
•
•
Change the NIBP measurements from Manual to Auto and set auto inflation interval (see page 79)
Stop monitoring (see page 81)
View Monitor status (see page 42)
View and change the alarm limits settings (see page 104)
Silence or enable the HR / PR beep tone
3.4.5 Monitor Status Screen
Touch Monitor Status on the Menu screen to access the Monitor Status screen.
The yellow dot indicates
RESP is available with
this Monitor
Use the Monitor Status screen to:
•
•
42
View the battery status
View the version of Monitor’s software
Display Screens
•
•
•
View the Monitor’s serial number
View the Monitor’s MAC address
View features that are available, such as RESP
3.4.6 Quiet Monitoring Screen
The Quiet Monitoring screen (blank screen) is the default when sensors are connected both to the Monitor
and the patient and no user interaction has occurred for a predefined period of time. Continuous
monitoring is in progress during this time.
Note: After a predefined period of no direct interaction with the Monitor, the Monitor locks
automatically and enters Quiet Monitoring.
The Quiet Monitoring Screen conserves battery power and minimizes patient disturbance. Vital signs
alarms and alerts remain active. Touching the screen continuously for 2 seconds resumes the Monitor’s
display with the Patient View screen.
Touchscreen
Microphone
Speaker
Power
Indicator
Note: When in Quiet Monitoring, the power indicator blinks approximately every 3 seconds. The
power indicator color is reflective of the battery status: “Green” indicates there is sufficient
battery charge for at least two hours of monitoring; “Yellow” indicates the battery charge is
depleted and there is less than 2 hours of monitoring available; and “Red” indicates the
battery charge is depleted and there is less than 30 minutes of monitoring available. When
the power indicator stops blinking, the battery charge is empty.
43
Display Screens
3.4.7 Patient View Screen
The Patient View screen appears whenever the touchscreen is touched continuously for 2 seconds during
Quiet Monitoring.
Unlock
Use the Patient View screen to:
•
•
•
44
View the current time
View battery charge level
Unlock the Monitor
4. Operation
4.1 Introduction
The ViSi Mobile Monitoring System is a sophisticated multi-parameter vital signs monitor. In order to
optimize the user of ViSi, please adhere to the following instructions related to patient set-up, initiating
monitoring and the removal of the System.
4.2 Preparing for a New Patient
In order to set up the complete ViSi Mobile Monitoring System, you will need the following components:
•
•
•
•
•
ViSi Mobile Patient Kit (select size)
ViSi Mobile Monitor
ViSi Mobile Cuff Module
ViSi Mobile Thumb Sensor
ViSi Mobile Chest Sensor Cable (3 lead-wire or 5 lead-wire configuration)
Note: Skin preparation equipment (skin preparation pads, scissors and/or razor as needed) not
included.
4.2.1 Inspecting the Equipment and Accessories
Before starting patient monitoring, you should visually inspect the ViSi Mobile Monitoring System
components:
1. For each component, examine the exteriors for cleanliness and general physical conditions.
Ensure the housings are not cracked or broken, that everything is present, there are no spilled
liquids and no signs of abuse.
2. Inspect all component cables for damage. Check their strain relief for general condition. Ensure
there are no breaks in the insulation. If any cables show signs of damage, do not use.
3. Inspect all disposable accessories (Wrist Cradle, Cuff, Thumb Strap, Securements, etc). If any
show signs of damage or pre-use, do not use.
45
Preparing for a New Patient
4.2.2 Applying Sensors
Applying the sensors is simple and may be done in any order. At the completion of the setup, the
components of the ViSi Mobile Monitoring System will be connected to the patient as shown in the
diagram below.
Upper Arm Module
(on Chest Sensor Cable)
Chest Module
(on Chest Sensor Cable)
(Temperature probe on
the back side of the
Chest Module must be
placed against the
patient’s skin)
Cuff Module
(Applied to upper arm)
Monitor
(in Wrist Cradle)
Thumb Sensor
Whenever a sensor is connected to the Monitor, a self-test of that sensor is initiated automatically to verify
the sensor is in good working order. If the sensor and Monitor speaker are in good working order, you will
hear a double beep. This process takes a few seconds, after which monitoring of the selected vital sign
commences as soon as the sensor is connected to the patient.
The double beep is also a validation that the Monitor speaker is in good working order and that audio tones
associated with alarms will be annunciated accordingly.
Alarm limits are set automatically according to default settings. See 6.6 Manage Alarm Limits on page
104.
Successful vital signs monitoring is dependent on several factors:
•
•
•
•
•
•
46
Determining the vital signs to be monitored
Selecting a Monitor and Cuff Module that are adequately charged for maximum duration of
uninterrupted monitoring
Selecting the 3 lead-wire or 5 lead-wire Chest Sensor Cable
Selecting the appropriately sized Cuff (from the Patient Kit)
Preparing the skin for ECG electrode placement
Correctly applying all sensors used for monitoring
Preparing for a New Patient
Note: The battery in the Monitor will deplete at a faster rate when sensors are connected to the
Monitor, even when monitoring has not been started.
Note: The Chest Module includes a body surface temperature probe. To ensure proper function,
place the temperature sensor on the body with the Chest Module “Front” label facing
forward (away from the patient’s skin).
4.2.3 Selecting Vital Signs to Monitor
The following vital signs may be monitored:
•
•
•
ECG (one or seven simultaneous leads, using the 3 lead-wire or 5 lead-wire Chest Sensor Cable
respectively)
 HR (from the ECG)
 RESP (optional)
 TEMP (Skin Temperature)
SpO2

NIBP



PR (from the Thumb Sensor)
SYS
DIA
PR (from NIBP)
4.2.4 Selecting the ViSi Mobile Chest Sensor Cable
The Chest Sensor Cable provides the sensors to monitor the ECG, HR, RESP (optional), and TEMP.
Note: The skin surface temperature probe is on the underside of the Chest Module. It must be
placed on the skin surface in order to properly measure skin surface temperature.
Select the Chest Sensor Cable that best suits the monitoring needs of your patient:
•
•
The 3 lead-wire Chest Sensor Cable monitors Lead II, or the MCL configuration.
The 5 lead-wire Chest Sensor Cable monitors seven leads of ECG simultaneously in lead
configurations I, II, III, aVR, aVL, aVF, and a V lead. The specific V lead depends on the
placement of the V electrode.
4.2.5 Selecting the ViSi Mobile Patient Kit
The System’s disposable components, including the Cuff are contained in the Patient Kit. The Patient Kits
are designated as S, M, and L based on the Cuff size.
Selection of the correct ViSi Mobile Disposable Cuff size is necessary to
ensure accurate NIBP measurements. A Cuff that is too small can result in a
falsely high NIBP measurement. A Cuff that is too large can result in a
falsely low NIBP measurement.
47
Preparing for a New Patient
Cuff / Patient Kit Size
Arm Circumference (cm)
Adult S
20 – 26
Adult M
25 – 34
Adult L
32 – 43
4.2.6 Checking the Battery Charge of the ViSi Mobile Monitor
and Cuff Module
Before you start to monitor your patient with the System, you will need to select both a Monitor and a Cuff
Module that are adequately charged for maximum duration of uninterrupted monitoring.
To check the battery charge of the Monitor
1. Turn on the display by touching the screen while the Monitor is in the Charger.
2. Verify that the large battery icon in the center of the screen is green.
A full green battery symbol indicates that the battery is fully charged. A partially green battery symbol
indicates the degree to which the battery is charged. The full monitoring period will not be achieved
unless the battery is fully charged
A yellow battery symbol indicates the battery is low with less than 2 hours of monitoring time left.
A red battery symbol indicates the battery is critically low with less than 30 minutes of monitoring time left.
Fully Charged
Battery Low
Battery Critically Low
48
Preparing for a New Patient
To check the battery charge of the Cuff Module
Press Battery Status button on the front of the Cuff Module.
There is a row of eight colored lights on the front surface of the Cuff Module.
Illuminated green lights indicate that the level of the battery charge is adequate for at least several NIBP
measurements. When six illuminated green lights are visible on the Cuff Module, the Module is fully
charged.
When the yellow light is illuminated, the battery charge is low. At least one NIBP measurement is possible.
When the red light is illuminated, the battery charge is too low for any further NIBP measurements.
Battery Status
Indicator (LEDs)
Battery Status
button
49
Applying ViSi Mobile Monitoring System / Initiate Monitoring
4.3 Applying ViSi Mobile Monitoring System / Initiate
Monitoring
The ViSi Mobile Monitor may be used to monitor one vital sign, such as SpO2, or multiple vital signs
simultaneously. Apply the appropriate sensor for each vital sign to be monitored, as described below. Start
by selecting the appropriately sized Patient Kit (S, M, L).
The Monitor’s ECG channel is capable of monitoring patients with an Implanted Pacemaker (PM),
Implantable Cardioverter-Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) device. A
vertical dashed line before the P wave (atrial pace), and before the QRS (ventricular pace) indicate paced
events. In the case of biventricular pacing (CRT), two vertical dashed lines occur before the QRS.
Note: Stimulus pulses from a pacemaker, as indicated by the vertical dashed lines, are not counted
as heartbeats, as defined by the pacer pulse rejection specification. See 9. Specifications on
page 125.
Pacemaker signals can differ among pacemakers, ICDs, or CRT devices.
The Association for the Advancement of Medical Instrumentation (AAMI)
cautions: “In some devices, rate meters may continue to count the
pacemaker rate during occurrences of cardiac arrest or some arrhythmias.
Do not rely entirely upon rate meter alarms”. All pacemaker patients should
be kept under close or constant observation.
External pacemakers or other external electrical stimulators may cause the
ViSi Mobile Monitor to produce erroneous results.
Only use the ViSi Mobile Chest Sensor Cable provided by Sotera Wireless,
Inc. with the ViSi Mobile Monitoring System. The Chest Sensor Cable is
designed to provide defibrillation protection as indicated in the
Specifications section of this manual. ViSi Mobile is designed to be
compatible with the use of external defibrillators.
Only use the ViSi Mobile Thumb Sensor provided by Sotera Wireless, Inc.
with the ViSi Mobile Monitoring System.
All components of the ViSi Mobile Patient Kit are for single patient use only.
To avoid possible cross contamination, do not reuse any of the items from
the Patient Kit on a patient other than the original patient. Dispose of the
ViSi Mobile Patient Kit items after use per your facility’s policy.
The ViSi Mobile Monitor, Thumb Sensor, Cuff Module, and the Chest Sensor
Cable must all be connected to the same arm for the System to function
correctly.
50
Applying ViSi Mobile Monitoring System / Initiate
4.3.1 Applying the ViSi Mobile Wrist Cradle
If there are no contraindications, for patient comfort, apply the Wrist Cradle to the patient’s wrist (either
left or right).
To apply the Wrist Cradle
1. Remove the Wrist Cradle from the Patient Kit.
2. Orient the Wrist Cradle with the flat end pointed towards the elbow, slide the patient’s hand
through the Wrist Strap and position the cradle on the top side of the wrist.
3. Pull snugly and secure.
Flat End
Rounded
End
The Wrist Strap should securely hold the ViSi Mobile Wrist Cradle in place
without impairing circulation. Immediately loosen the Wrist Strap if the
patient complains of pain, tingling, or numbness in the affected hand or
wrist.
4. Placing the flat end in first, insert the Monitor into the Wrist Cradle and push down.
When the Monitor is pushed down all the way, you will hear a “clicking” sound.
Note: The Monitor is not completely secured within the Wrist Cradle until the Thumb Sensor or
Locking Plug is inserted into the connector on the rounded end of the Monitor.
Flat End
Wrist Cradle
Rounded
End
51
Applying ViSi Mobile Monitoring System / Initiate Monitoring
When inserting the ViSi Mobile Monitor into the Wrist Cradle, ensure proper
alignment: flat end to flat end and the round end is pointing down towards
the wrist.
To avoid damage from dropping the ViSi Mobile Monitor, ensure that the
Wrist Strap is snugly wrapped around the wrist.
To avoid damage from dropping the ViSi Mobile Monitor, make sure that the
Monitor is securely snapped into the ViSi Mobile Wrist Cradle.
5. If you are not performing SpO2 monitoring, secure the Monitor to the cradle by inserting a Locking
Plug into the opening on the rounded end of the Monitor.
Locking Plug
4.3.2 Applying Sensors
The ViSi Mobile Monitor, Thumb Sensor, Cuff Module, and the Chest Sensor
Cable must all be connected to the same arm for the System to function
correctly.
Vital signs monitoring starts automatically as soon as a sensor is connected to the Monitor and attached to
the patient. When performing a patient setup, the alarms pause automatically, allowing you to complete the
setup before the alarms are turned on.
Sensors are designed to securely plug into the Monitor so that they cannot fall out unintentionally.
You should hear a double-beep sound when a sensor is inserted correctly.
52
Applying ViSi Mobile Monitoring System / Initiate
4.3.3 Applying the ViSi Mobile Thumb Sensor
The ViSi Mobile Thumb Sensor is intended for use on the patient’s thumb
only. Do not apply the Thumb Sensor to the patient’s fingers.
To apply the Thumb Sensor
1. Remove the Thumb Cradle from the Patient Kit.
2. Insert the Thumb Sensor into the Thumb Cradle such that the sensor optics are pointing away from
the Thumb Cradle.
Optics
Thumb Sensor
Thumb Cradle
3. Place the Thumb Sensor at the base of the thumb and secure it with the Thumb Strap.
53
Applying ViSi Mobile Monitoring System / Initiate Monitoring
The Thumb Cradle is designed to hold the Thumb Sensor in place securely without impairing
circulation.
Ensure that the ViSi Mobile Thumb Sensor is securely fastened. A Thumb
Sensor that is wrapped too tight or too loose can adversely affect SpO2
measurement.
Inspect patient’s skin at sensor site every 8 hours. If skin surface has been
compromised, reposition the ViSi Mobile Thumb Sensor or move the Thumb
Sensor to the patient’s other thumb.
4. Check the patient’s thumb for good color and circulation to ensure that the Thumb Sensor has not
restricted circulation.
The Thumb Strap should securely hold the ViSi Mobile Thumb Sensor in
place without impairing circulation. Immediately loosen the Thumb Strap if
the patient complains of pain, tingling, or numbness in the affected thumb.
5. Connect the Thumb Sensor into the connector on the rounded end of the Monitor with the
connector contacts facing upwards.
The monitoring of SpO2 and the PR starts after a few seconds. Alarm limits are set automatically
according to predefined settings. See 6.6 Manage Alarm Limits on page 104.
Pulsating
Indicator Bar
6. While palpating the pulse in the wrist of the arm opposite the Monitor, watch the pulsating
indicator bar to the right of the SpO2 numeric and ensure that the bar fluctuates with the pulse.
The pulsating indicator bar confirms signal adequacy by moving up and down in sync with the
detection of pulsating blood flow. Use the pulsating indicator bar to confirm the Thumb Sensor is
optimally placed. It may take several seconds for the signal to stabilize.
54
Applying ViSi Mobile Monitoring System / Initiate
The indicated PR should match the palpated pulse rate. PR is replaced with HR when measuring
ECG and SpO2 simultaneously.
Note: If sensing of the SpO2 or the PR is erratic, loosen the Thumb Strap from the thumb and
reposition the Thumb Sensor until a stable SpO2 and PR are obtained. Re-secure the Thumb
Sensor with the Thumb Strap.
Only Sotera Wireless, Inc. supplied ViSi Mobile Thumb Sensors should be
used. Using non-approved Thumb Sensors may result in inaccurate SpO2
readings.
55
Applying ViSi Mobile Monitoring System / Initiate Monitoring
4.3.4 Applying the ViSi Mobile Chest Sensor Cable and ECG Electrodes
Use all of the same type of high quality ECG electrodes on the patient.
Mixing ECG electrode types can adversely affect ECG monitoring.
To ensure patient safety, the conductive parts of the ECG electrodes,
including connectors and other patient-applied components, should not
contact other conductive parts, or earth ground, at any time.
Only use the ViSi Mobile Chest Sensor Cable provided by Sotera Wireless,
Inc. with the ViSi Mobile Monitoring System. The Chest Sensor Cable is
designed to provide defibrillation protection as indicated in the
Specifications section of this manual. ViSi Mobile is designed to be
compatible with the use of external defibrillators.
Never connect the ViSi Mobile Chest Sensor Cable directly to the AC power
outlet.
Skin Preparation
Skin preparation and ECG electrode placement directly impact the quality of the ECG signal and HR
determinations. The following steps are recommended for skin preparation:
•
•
•
Select ECG electrode sites on the patient’s chest
 Choose sites that are flat, avoiding fatty areas and major muscles.
 For patient comfort, avoid placing ECG electrodes where lying on the side will put
pressure on the ECG electrode.
 Sites just below the middle of the clavicles are good locations for the RA and LA ECG
electrodes.
If needed, shave or clip hair in approximately a 1.5 to 2-inch diameter area for each ECG electrode
site.
 Also, for patient comfort, shave or clip hair from the areas where the Chest Sensor Cable
and upper arm sensor are secured.
Thoroughly clean the sites to remove excess skin oils, skin cells, and residue from the ECG
electrode sites.
 You may use isopropyl alcohol prep pads or another skin preparation pad, or soap and
water.
 Gently rub the site dry with a dry gauze pad or other dry pad.
Note: To avoid skin irritation, avoid areas that appear damaged; remove ECG electrodes if the
patient complains of pain/itching; replace ECG electrodes per the electrode manufacturer’s
instructions and place on different sites.
Note: Only use snap-on type electrodes.
56
Applying ViSi Mobile Monitoring System / Initiate
3 lead-wire and ECG Electrode Placement
With the 3 lead-wire Chest Sensor Cable, the ECG channel provides Lead II only. The ECG electrode
placement shown in the diagram below is recommended for Lead II monitoring
Lead Wire Color Code - U.S. (AAMI)
RA - White
LA - Black
LL - Red
Lead Wire Color Code - International (IEC)
R - Red
L - Yellow
F - Green
57
Applying ViSi Mobile Monitoring System / Initiate Monitoring
5 lead-wire and ECG Electrode Placement
With the 5 lead-wire Chest Sensor Cable, the ECG channel is capable of monitoring seven leads
simultaneously (Lead I, II, III, aVR, aVL, aVF, and a V lead). The ability to monitor multiple leads
simultaneously improves beat detection to determine the HR and minimizes false detections as a result of
artifact. The ECG electrode placement shown in the diagram below is recommended.
Lead Wire Color Code - U.S. (AAMI)
RA - White
LA - Black
LL - Red
V - Brown
RL - Green
V1
4th intercostal space (just right of sternum)
V2
4th intercostal space (just left of sternum)
V3
Midway between V2 and V4
V4
Mid clavicular line, 5th intercostal space
V5
Anterior axillary line, between V4 and V6
V6
Mid axillary line, horizontal with V4
Lead Wire Color Code - International (IEC)
R - Red
L - Yellow
F - Green
C - White
N - Black
Note: Place the V lead in the position appropriate to your monitoring requirements: V1, V2, V3,
V4, V5 or V6.
Note: The ECG waveform can be displayed one lead at a time on the ViSi Mobile Monitor.
58
Applying ViSi Mobile Monitoring System / Initiate
To apply the Chest Sensor Cable
Avoid placing the ViSi Mobile Cable Securement and ECG electrodes over
areas of abrasions, irritation, or other sensitive areas. If possible, remove,
reposition, and replace ECG electrodes and Cable Securement if the patient
complains of pain/itching at the sites.
1.
2.
3.
4.
Remove the ECG electrodes from the Patient Kit.
Apply the ECG electrodes to the prepared sites on the chest as shown.
Remove the large Cable Securement from the Patient Kit.
Secure the Chest Module of the Chest Sensor Cable between the sternum and the shoulder (same
side as the Monitor) using the large Cable Securement.
Note: The Chest Sensor Cable should be oriented vertically. Do not orient the sensor more than 45
degrees to the left or right.
Note: Ensure the “Front”, “ViSi Mobile” and “Defibrillation” labels on the Chest Module of the
Chest Sensor Cable are facing outwards away from the patient’s skin.
Note: Ensure the “barcode” label and the Temperature sensor on the Chest Modole of the Chest
Sensor Cable are placed inwards directly against the patient’s skin.
Note: For patient comfort, shave or clip the hair in the areas where the Cable Securement come in
contact with the chest.
5. Apply the lead wires from the Chest Sensor Cable to the ECG electrodes.
Note: For patient comfort lead wires may be attached to ECG electrodes prior to applying the
electrodes to the patient’s chest.
6. Remove the small Cable Securement from the Patient Kit.
59
Applying ViSi Mobile Monitoring System / Initiate Monitoring
7. Secure the Upper Arm Module of the Chest Sensor Cable on the outside of the upper arm using the
small Cable Securement.
Chest Module (front view)
(Place this side away from the patient’s skin)
Small
Block
Large
Block
Temperature Probe
Lead wires
pointing downwards
Chest Module (rear view)
(Place this side against patient’s skin
Note: The default ECG configuration is Lead II.
8. Plug the Chest Sensor Cable into any of the three ports on the flat end of the Monitor with the
connector contacts facing upwards.
Note: Monitoring of ECG, HR, RESP (optional), and TEMP starts automatically. Alarm limits are
set automatically according to predefined settings.
Note: Only attach one ViSi Mobile Chest Sensor Cable to the patient and ViSi Mobile Monitor.
Insert with connectors
contacts facing upwards
9. While palpating the pulse in the wrist of the arm opposite the Monitor, watch the beating heart
symbol at the top left of the HR numeric to ensure that it fluctuates with the patient’s heart beat.
The heart symbol beats with the pulse to confirm that the sensor is optimally placed. It may take
several seconds for the signal to stabilize.
60
Applying ViSi Mobile Monitoring System / Initiate
•
•
The indicated HR should match the palpated pulse rate.
If the indicated HR is erratic or doesn’t match the palpated pulse rate, check to make sure
that the ECG electrodes and lead wires are secure.
Note: In rare circumstances, the ECG electrodes may need to be placed in different locations to
improve the ECG signal.
10. While observing the patient, count the respiration rate and compare it to the RESP rate on the
Monitor. It may take several seconds for the signal to stabilize.
• The indicated RESP should match the observed rate.
• If the indicated RESP is erratic or doesn’t match the observed rate, check to make sure that
the ECG electrodes and lead wires are secure.
Note: The Temperature sensor takes several minutes to reach a stable temperature reading.
4.3.5 Applying the ViSi Mobile Cuff Module and Disposable Cuff
ViSi Mobile Disposable Cuffs are for single patient use only. To avoid
possible cross contamination, do not reuse a Cuff on a patient other than the
original patient.
To apply the Cuff Module
1. Remove the Cuff from the Patient Kit.
2. Squeeze as much air out of the Cuff as possible.
3. Ensure that the patient is resting so that the upper arm muscles are relaxed. The level of the middle
of the Cuff, while the arm is at rest, should be approximately at heart level.
4. Wrap the Cuff around the upper part of the same arm to which the Monitor is attached.
• Align the bottom part of the Cuff approximately 1” above the antecubital fossa.
• Align the artery marker on the Cuff with the brachial artery.
• The connector for the Cuff Module should be to the outside of the arm, away from the
body.
• Have the patient remain still to avoid the introduction of unnecessary motion artifact.
Note: The ViSi Mobile Disposable Cuff is designed to be used on the same arm with the other ViSi
Mobile sensors. It may temporarily cause the loss of function of other devices (not ViSi
Mobile) simultaneously used on the same limb.
Note: Only attach one ViSi Mobile Cuff Module to the ViSi Mobile Monitor.
The ViSi Mobile Disposable Cuff should be snug enough to support the Cuff
Module while not impairing circulation when deflated.
Avoid applying the ViSi Mobile Disposable Cuff over a wound as this can
cause further injury.
61
Applying ViSi Mobile Monitoring System / Initiate Monitoring
Avoid applying the ViSi Mobile Disposable Cuff on any limb where
intravascular access or therapy, or an arterio-venous (A-V) shunt, is present
because of temporary interference to blood flow which could result in injury
to the patient.
Take care in the application of the ViSi Mobile Disposable Cuff when
applying the Cuff to an arm on the same side of a mastectomy.
ViSi Mobile arterial measurements have not been clinically tested in the
presence of actual or ventricular arrhythmias. Use alternative BP methods if
these arrythmias are present.
5. Connect the Cuff Module securely to the Cuff with the cable in the direction of the Monitor.
Inflate the ViSi Mobile Disposable Cuff only after proper application to the
patient’s limb.
6. Plug the Cuff Module into any of the open ports on the flat end of the Monitor with the connector
contacts facing upwards.
Insert with connector
contacts facing upwards
62
Removing ViSi Mobile Monitoring System
The Start symbol on the NIBP Start button blinks, prompting you to start a Cuff inflation. See
Taking a NIBP Measurement on page 75 for instructions on how to take a NIBP measurement.
4.4 Removing ViSi Mobile Monitoring System
All disposable components of the ViSi Mobile Monitoring System are for
single patient use only. To avoid possible cross contamination, do not reuse
any disposable items on a patient other than the original patient.
To remove Cuff and Cuff Module
1. Disconnect the Cuff Module from the Monitor: Grasp the Cuff Module cable near the plug and,
while holding the Monitor still, pull out the plug.
2. Unwrap the Cuff from the arm.
3. If the patient will no longer be monitored:
• Disconnect the Cuff Module from the Cuff.
• Dispose of the Cuff according to your facility’s policy.
To remove the Chest Sensor Cable
1. Disconnect the Chest Sensor Cable from the Monitor: Grasp the Chest Sensor Cable cable near
the plug and, while holding the Monitor still, pull out the plug.
2. Remove the Cable Securements from the patient’s chest and arm and dispose of them according to
your facility’s policy.
3. To prevent placing stress on the lead wires, grasp each lead wire near the connection to the ECG
electrodes. Pull the lead wires from the ECG electrodes.
4. Carefully remove the ECG electrodes from the patient and dispose of them according to your
facility’s policy.
To remove the Thumb Sensor
1. Disconnect the Thumb Sensor from the Monitor: Grasp the Thumb Sensor cable near the plug
and, while holding the Monitor still, pull out the plug.
2. Remove the Thumb Sensor from the patient.
3. Holding the ends of the Thumb Sensor between your thumb and index finger, gently bend the
Thumb Sensor backwards until it releases from the Thumb Cradle.
4. If the patient will no longer be monitored, dispose of the Thumb Cradle and Thumb Strap
according to your facility’s policy.
To remove the Wrist Cradle and Monitor
1. For ease of removal of the Wrist Cradle and Monitor, ensure all sensors are disconnected from the
Monitor.
2. Remove the Monitor from the Wrist Cradle.
3. Unwrap the Wrist Strap from the patient’s wrist and remove the Wrist Cradle from the patient’s
wrist.
4. If the patient will no longer be monitored, dispose of the Wrist Cradle and Wrist Strap according to
your facility’s policy.
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Removing ViSi Mobile Monitoring System
Clean the reusable components of the System: Monitor, Chest Sensor Cable, Thumb Sensor, and Cuff
Module, in accordance with your facility’s procedures and the cleaning recommendations in this manual.
See 7. User Maintenance on page 109.
64
5. Patient Monitoring
5.1 Introduction
The ability to monitor patients with a patient-worn ViSi Mobile Monitoring System opens up many
opportunities to assess vital signs during all phases and activities involved in a patient’s recovery process.
65
Monitoring the Patient
5.2 Monitoring the Patient
RESP (chest wall motion) can continue in the absence of ventilation
(obstructed airway). Do not rely on the RESP alone to determine adequacy
of ventilation. Other vital signs, such as HR and SpO2, should be assessed
as well.
Impedance pneumography for the determination of respiration (RESP) is not
recommended for use in the presence of mechanically induced, high
frequency ventilation.
The ViSi Mobile Monitor does not provide automated arrhythmia analysis.
As a result, certain arrhythmias may cause the Monitor to display inaccurate
heart rates. If frequent arrhythmias are suspected, their presence should be
confirmed by another method, such as a 12-lead ECG or Holter monitoring.
The ViSi Mobile Monitor does not have automated ST segment analysis,
therefore, if a change in the ST segment of the ECG waveform is suspected,
it should be confirmed by another method, such as a 12-lead ECG.
Oxygen saturation measurements using SpO2 are dependent on proper
sensor placement and general patient conditions. Before making clinical
decisions based on SpO2 measurements, verify the measurement using
another clinically acceptable method, such as an arterial blood gas analysis.
TEMP monitoring with the ViSi Mobile Monitoring System is intended for
trending purposes only and is not intended to replace core temperature
monitoring. Before making clinical decisions based on the skin temperature
measurement, verify the measurement using another clinically acceptable
method of temperature measurement.
To prevent settings from being inadvertently changed, lock the ViSi Mobile
Monitor screen (if enabled) as soon as tasks are completed.
The ViSi Mobile Monitoring System does not support printing capability.
66
Monitoring the Patient
5.2.1 Unlocking the Monitor
If your System is configured to require authorization to view the Vital Signs screen, you must first unlock
the Monitor by entering a PIN code. If you do not have a PIN code, please see your system administrator.
If your System is not configured to require authorization, the Enter Pin Code screen does not appear.
To unlock the Monitor
1. With one finger, touch the Monitor’s screen for two seconds to activate the Monitor’s display.
The Patient View screen appears.
2. Touch Unlock in the lower left corner of the screen.
The Enter PIN Code screen appears.
Message
area
Return to
previous
screen
3.
Enter PIN code on the PIN code pad.
As PIN digits are entered, a white dot appears in the message area for each digit entered and the
Return to Previous Screen button changes to a Cancel button.
4. Touch Confirm to enter the PIN code and confirm authorization.
67
Monitoring the Patient
If you touch the Confirm button the system navigates to the Vital Signs screen (when a valid PIN
code has been entered). If you touch the Cancel button, the entered PIN code is cleared and the
Return to Previous Screen button appears allowing to return to the Patient View screen.
Note: When an invalid PIN code is entered, the outline of the PIN code buttons will flash red and
the entered PIN code is cleared.
5.2.2 Locking the Monitor
When you have finished working with the Monitor, you should lock the Monitor to prevent the patient
from accidentally accessing clinical settings.
To lock the Monitor
1. When you are finished interacting with the patient and the Monitor, touch Lock.
The Vital Signs screen is locked to prevent settings from being inadvertently changed. The Patient
View screen appears.
68
Monitoring the Patient
5.2.3 Viewing Vital Signs
Vital signs monitoring, with alarms, starts as soon as a sensor is connected to the patient and plugged into
the Monitor. When there has been no interaction with the Monitor for a period of time, the display goes
into Quiet Monitoring.
To view vital signs
1. With one finger, touch the Monitor screen for two seconds to activate the display.
2. Enter your PIN code if required. See To unlock the Monitor on page 67.
The Vital Signs screen appears and displays all currently monitored vital signs.
Cuff Module connected
Cuff Module not connected
Note: If the Cuff Module is not connected, the Start NIBP button is disabled and the NIBP numeric
display area is blank.
Note: The vital sign measurements are refreshed every 3 seconds.
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Monitoring the Patient
5.2.4 Viewing Waveforms Associated with Vital Signs
Waveforms move across the display from left to right. A sweep bar erases the oldest waveform and
replaces it with the newest waveform as it moves from left to right.
Sweep
Bar
Pacer
Spike
The speed of the waveform display (sweep speed) is scaled to 25 mm/sec for ECG and SpO2 waveforms.
The sweep speed of the RESP waveform display is scaled to 6.25 mm/sec. The RESP frequency is less
than the ECG or SpO2. The slower sweep speed for the RESP waveform compensates for the lower
frequency of activity in order to display several RESP cycles on the display.
Note: The NIBP measurement does not have a waveform.
To view the ECG waveforms
Depending on which Chest Sensor Cable is connected (3 lead-wire or 5 lead-wire), several views (leads) of
the ECG waveform may be available for view.
Note: It is recommended that you step through the available ECG waveform leads to confirm the
ECG setup is correct.
Note:
When using a 3 lead-wire Chest Sensor Cable, only a Lead II waveform is available.
Note: There is no pacer detection with a 3 lead-wire Chest Sensor Cable.
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Monitoring the Patient
1. Touch the HR numeric.
ECG Lead
selection
The top third of the display is replaced with the ECG waveform. The displayed lead is indicated to
the left of the waveform. The square wave indicates the standard calibration of the ECG waveform.
To view other leads with the 5 lead-wire Chest Sensor Cable
1. Touch ECG Lead Selection or the waveform.
The lower part of the display is replaced with Lead Selection buttons.
2. Select the lead corresponding to the waveform that you want to view.
All available leads can be viewed one at time from this view.
Note: Selecting different leads to view has no affect on monitoring. All available leads are
monitored simultaneously and continuously. The lead selection affects only the display.
3. Touch Return to Previous Screen to exit this view.
The display returns to the previous view of the ECG waveform and vital signs.
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Monitoring the Patient
4. To return to the main Vital Signs screen, touch the HR numeric.
The ECG waveform is no longer displayed.
Note: When you touch a vital sign, its corresponding waveform is displayed, even if another
waveform is currently displayed.
Input Overload / Dynamic Range
The ViSi Mobile Monitor display indicates an input overload condition (i.e. the input dynamic range of the
amplifier associated with the displayed ECG lead has been exceeded) by displaying the trace in red at the
top (or bottom) of the ECG waveform display area.
Amplifier is overloaded due to an input
that exceeds the positive limit of the
dynamic range on a continuous basis
Positive limit of the dynamic range is
being exceeded only at the peaks of the
QRS complex of the ECG waveform
Dynamic range of the ECG amplifier
has not been exceeded, but in which
the peaks of the QRS complex of the
ECG waveform extend beyond the
upper edge of the display area
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Monitoring the Patient
To view the RESP waveform
1. Touch the RESP numeric.
The top third of the display is replaced with the RESP waveform.
2. To return to the main Vital Signs screen, touch the RESP numeric.
The RESP waveform is no longer displayed.
To view the SpO2 waveform
1. Touch the SpO2 numeric.
The top third of the display is replaced with the SpO2 waveform.
2. To return to the main Vital Signs screen, touch the SpO2 numeric.
The SpO2 waveform is no longer displayed.
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Monitoring the Patient
5.2.5 Motion Artifact
If a vital sign cannot be measured due to a motion artifact, the word “MOTION” displays below the vital
sign name, and “xx” is displayed in place of the numeric(s).
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Monitoring the Patient
5.2.6 Taking a NIBP Measurement
The industry-standard technique of oscillometry is used for non-invasively measuring systolic blood
pressure (SBP) and diastolic blood pressure (DBP). The method is based on the measurement of
oscillations through the occluding cuff which is placed on the patient’s upper arm during an NIBP
measurement. The pulsatile oscillations are measured using a pressure transducer, and then digitized using
a microprocessor. The NIBP algorithm uses the digitized oscillations and applied cuff pressure as input to
an empirical model to calculate SBP and DBP.
Blood pressure measurements can be affected by the patient’s position and/or physiological condition:
•
•
•
The cuff should be at the same level as the patient’s heart.
NIBP are not reliable indicators for patients with arterial or frequent premature ventricular beats.
Improper cuff size or application may lead to inaccurate readings.
This section describes how to take a single NIBP measurement and how to initiate automatic NIBP
measurements at various intervals. For patient comfort, when the NIBP is set to manual, remove the Cuff
and the Cuff Module from the patient's arm. Once removed, disconnect the Cuff Module from the Monitor
between measurements. Store the Cuff and Cuff Module in a convenient location.
The ViSi Mobile Monitor should never be used to measure the NIBP of one
patient while the Monitor is simultaneously connected to another patient.
Do not attempt to take NIBP measurements with the ViSi Mobile Monitor
while the patient is undergoing cardio-pulmonary bypass.
Do not attempt to take NIBP measurements with the ViSi Mobile Monitor
while the patient is being treated with an intra-aortic balloon pump or left
ventricular assist device.
Periodically observe the patient’s arm for signs of impaired circulation, which
may be a result of measurements made too frequently. Loosen or remove
the ViSi Mobile Disposable Cuff if signs and/or symptoms of prolonged
impaired circulation are evident.
If you are uncertain of the reliability of an NIBP measurement, repeat the
measurement. If the reading is still suspect, use another method to measure
the blood pressure.
The ViSi Mobile Disposable Cuff should be snug enough to support the Cuff
Module while not impairing circulation when deflated.
Note: The ViSi Mobile Cuff Module cannot be used with the auscultatory method of measuring
NIBP.
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Monitoring the Patient
To take a single NIBP measurement
1. Apply the Cuff and Cuff Module. See Applying the ViSi Mobile Cuff Module and Disposable Cuff
on page 61.
After the Cuff Module has been connected to the Monitor, the NIBP vital sign numerics (Systolic
and Diastolic) display as “xx”, indicating no measurement has been taken.
2. Touch Start NIBP to start a measurement.
After a few seconds to zero and calibrate the barometric pressure, the Cuff begins inflating.
An inflation pressure indicator bar, located to the left of the NIBP numerics, increases/decreases in
height as the pressure increases/decreases in the Cuff. The actual cuff pressure is displayed under
the NIBP label.
Once the Cuff begins to inflate, the Start NIBP button changes to Stop NIBP.
Note: If unexpected readings are encountered, confirm the correct application of the ViSi Mobile
Disposable Cuff (see page 61). If unexpected readings persist, have maintenance performed
as described in the Technical Reference Manual.
The performance of the automated sphygmomanometer may be affected by
extremes of temperature, humidity and altitude. See “Specifications” on
page 125.
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Monitoring the Patient
Upon completion of a successful measurement, the Systolic and Diastolic measurements are displayed in
white. The time of the measurement is displayed below the NIBP label. If there is no other heart rate/pulse
rate source (i.e. Thumb Sensor or Chest Sensor Cable are not connected to the Monitor), then a one-time
PR from the NIBP measurement is displayed next to the NIBP measurement for 30 seconds.
Time of
Measurement
Systolic
Diastolic
Note: If the NIBP measurement was unsuccessful, the Cuff Module automatically retries to
measure the blood pressure. A maximum of 3 attempts will be made. If the failure is due to a
cuff leak or cuff occlusion, there is no retry and the LEAK or OCCL message appears on the
screen directly below the NIBP label.
NIBP numerics fade and shrink in size after 30 seconds to indicate that the reading is not recent.
Current Reading
Older Reading
Note that the numerics for the older
reading are faded and shrunk in size
NIBP measurements that are older than 30 minutes are no longer displayed.
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Monitoring the Patient
To stop an NIBP measurement
An NIBP measurement currently in progress may be stopped at any time.
Inflation Pressure
(mmHg)
Stop Cuff
Inflation Pressure
Indicator Bar
Touch Stop NIBP to stop the cuff inflation and NIBP measurement.
The cuff will deflate.
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Monitoring the Patient
5.2.7 Initiating Automatic NIBP Measurements
When frequent NIBP measurements are required, the Monitor can be set up to automatically take a blood
pressure measurement every 5, 10, 15, 30, 60, 90 or 120 minutes.
To initiate automatic NIBP measurements
1. Apply the Cuff and Cuff Module.
See Applying the ViSi Mobile Cuff Module and Disposable Cuff on page 61.
The ViSi Mobile Disposable Cuff should be snug enough to support the Cuff
Module, while not impairing circulation when deflated.
Use care when using automatic cuff inflation for prolonged periods on
unconscious or semi-conscious patients since the patient may not be able to
alert the clinician to any pain he/she may be experiencing. Pressing the
“Stop NIBP” button interrupts the NIBP measurement and deflates the cuff.
2. Set the NIBP mode to Automatic.
a. Touch Menu on the Vital Signs screen to display the Menu screen.
The Menu screen appears.
b. Touch NIBP Settings to display the Cuff Management screen.
The Cuff Management screen appears.
Manual
Cuff Inflation
Automatic
Cuff Inflation
c. Touch Automatic Cuff Inflation.
d. Touch the Up or Down arrow to increase or decrease the time interval.
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Monitoring the Patient
e. Touch Confirm to confirm the new settings.
- or Touch Cancel to return to the Menu screen.
Once you have touched Confirm, an automatic NIBP measurement is taken immediately, and
again at the set interval. The Automatic setting is saved and the system returns to the Vital Signs
screen. If you touch Cancel, the system discards the changed settings and returns to the Menu
screen.
Note: As long as the NIBP Module is plugged in, a manual NIBP measurement can be initiated at
any time. If the timing of the manual measurement overlaps with the automatic
measurement interval, then that automatic measurement is skipped; otherwise the automatic
measurement occurs as scheduled.
Note: Touching the “Stop NIBP” button on the Vital Signs screen interrupts any NIBP
measurement cycle presently in progress. The next automatic measurement will occur as
scheduled.
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Monitoring the Patient
5.2.8 Viewing Patient’s Demographics
To Confirm Patient’s Demographics
When the patient’s demographics have been changed on the ViSi Remote Viewer or there is an interruption
of monitoring of more than 30 seconds, the demographics must be confirmed (or rejected) directly on the
ViSi Mobile Monitor.
Patient’s Primary (displayed in blue)
Secondary and Tertiary Ids
Birth Gender / Age
Date of Birth
Note: The patient’s primary id will be displayed in blue to indicate the demographics have been
changed and require confirmation.
Note: The primary id is configured to be the patient’s name. The secondary id is configured to be
the patient’s MRN#. The tertiary id is configured to be an alternative id.
1. Touch Confirm to confirm the patient’s demographics are correct.
- or -
Touch Cancel.
If cancelled, the patient’s demographics will be removed from the ViSi Mobile Monitor and an alert
will be annunciated on the ViSi Remote Viewer.
If confirmed, the patient’s demographics will be displayed in white to indicate they have now been
confirmed.
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Monitoring the Patient
To View Patient’s Demographics
1. Touch Menu on the Vital Signs screen to display the Menu screen.
The Menu screen appears.
2. Touch Patient Information to display the Patient Information screen.
The Patient Information screen is displayed.
Patient’s Primary
Secondary and Tertiary Ids
Birth Gender / Age
Date of Birth
Note: The primary id is configured to be the patient’s name. The secondary id is configured to be
the patient’s MRN#. The tertiary id is configured to be an alternative id.
Note: The patient’s demographics are entered on the ViSi Remote Viewer.
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Monitoring the Patient
5.2.9 Exchanging a Monitor With Low Battery
To exchange a monitor with a low battery
When the ViSi Mobile Monitor’s battery becomes low during monitoring, it may be exchanged with a new
Monitor without stopping the patient’s monitoring session.
1. Remove the new Monitor from the ViSi Mobile Charger.
The Device Status screen will be displayed.
Device Swap
button
Button is disabled when
the battery life of the
new monitor is too low
2. Touch Device Swap.
The Device Swap Instructions screen will be displayed and the Monitor will connect to the
network.
Note: The Monitor may take a few seconds to connect to the network. Do not attempt to bump the
two monitors together until the new Monitor has connected to the network.
Note: Monitors must be double bumped with long ends in the same direction. See image on the
ViSi Mobile Monitor instructions screen.
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Monitoring the Patient
3. Double bump the new Monitor with the Monitor on the patient’s wrist.
- or -
Touch Cancel.
If cancelled, the Device Swap will automatically be cancelled.
If the monitors are successfully double bumped, the Device Swap process will be initiated. The
new Monitor will display the Waiting Patient Transfer screen and the patient’s Monitor will
display the Confirm Device Swap screen.
Waiting Patient Transfer
(Instructions on the new Monitor)
Confirm Device Swap
(Instructions on the patient’s Monitor)
4. Touch Confirm to replace the existing patient’s Monitor with the new Monitor.
- or -
Touch Cancel.
If cancelled, the Device Swap will automatically be cancelled.
If confirmed, the patient’s demographics will be transferred from the patient’s Monitor to the new
Monitor. The new Monitor will display the Operation Instructions screen and the patient’s
Monitor will display the Disconnect Sensors screen.
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Monitoring the Patient
Operation Instructions
(Instructions on the new Monitor)
Disconnect Sensors
(Instructions on the patient’s Monitor)
Note: During the exchange, you will need to confirm the patient’s identification on the patient’s
Monitor, if it has not already been confirmed.
Note: During the exchange, you will need to enter your pin code on the patient’s Monitor, if it has
not already been entered.
5. To stop monitoring on the patient’s Monitor and complete the exchange, disconnect the sensors
from the Monitor within 2 minutes.
If the sensors are not disconnected from the patient’s Monitor within 2 minutes, monitoring will
continue on the patient’s Monitor and the Device Swap process will be cancelled.
Once the sensors have been disconnected, the new Monitor may be placed in the cradle and the
sensors connected.
Instructions
(Patient’s New Monitor)
Device Status
(Original Patient’s Monitor)
6. To restart monitoring, place the new Monitor into the Wrist Cradle (attached to the patient’s wrist)
and connect the sensors.
Note: When monitoring is restarted, the patient’s demographics will need to be reconfirmed on the
new Monitor.
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Monitoring the Patient
5.2.10 Stop Monitoring
Stop monitoring when ALL vital signs monitoring is no longer required.
To stop monitoring
1. With one finger, touch the Monitor screen for two seconds to activate the display.
The Patient View screen appears.
2. Enter your PIN code if required. (See To unlock the Monitor on page 67.)
The Vital Signs screen appears.
3. Touch MENU.
The Menu screen appears.
4. Touch STOP.
The Stop Monitoring screen appears.
5. Touch Confirm to confirm that you want to stop monitoring.
- or -
Touch Cancel.
If cancelled, the program returns to the Menu screen and monitoring continues uninterrupted.
If confirmed, the Stop-Disconnect Sensors/Clean Monitor screen is displayed showing a 2 minute
countdown timer.
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Monitoring the Patient
6. Remove all the sensors and the Monitor from the patient.
All sensors must be removed from the patient and/or the Monitor to stop monitoring. When the
countdown has elapsed, if vital sign measurements are still being detected (at least one sensor is
still connected to the patient and Monitor), monitoring will continue without interruption.
7. To remove the sensors from the Monitor, grasp the sensors near the plug, and while holding the
Monitor firmly, pull out the plug.
Once all the sensors are disconnected from the Monitor, the Monitor Status screen appears briefly
before the System transitions into the Hibernate mode.
8. Dispose of disposable components per your facility’s procedures.
If you want to stop monitoring temporarily or change the Monitor, you will need to stop monitoring on the
current Monitor and start monitoring again using the steps outlined in section Applying ViSi Mobile
Monitoring System / Initiate Monitoring on page 50.
To clean and prepare reusable components
1. Clean and prepare the reusable components of the System (Monitor, Chest Sensor Cable, Thumb
Sensor, and Cuff Module) in accordance with your facility’s procedures and the cleaning
recommendations in this manual. See 7.User Maintenance on page 109.
2. Place the cleaned Monitor and Cuff Module into the Charger.
Never place the ViSi Mobile Monitor or the ViSi Mobile Cuff Module into the
ViSi Mobile Charger while connected to a patient.
Never connect the ViSi Mobile Monitor directly to an AC power outlet. To
recharge the battery, disconnect the Monitor from the patient, and then place
it in the ViSi Mobile Charger.
Never connect the ViSi Mobile Cuff Module directly to an AC power outlet.
To recharge the battery, disconnect the Cuff Module from the patient, and
then place it in the ViSi Mobile Charger.
To prevent possible cross-contamination, properly clean and disinfect all
reusable components between patients.
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All Sensors Disconnected
5.3 All Sensors Disconnected
The “All Sensors Disconnected” screen will be displayed when the last sensor is disconnected from the
ViSi Mobile Monitor without going through the proper “Stop Monitoring” procedure. (see 5.2.8Viewing
Patient’s Demographics on 81). An “All Disconnected” alert will be generated.
1. To stop monitoring the patient, touch Stop to initiate the Stop Monitoring process.
- or to resume monitoring, connect the sensor(s) to restart monitoring.
Monitoring will automatically continue.
2. Enter your PIN code if required. (See To unlock the Monitor on page 67.)
The Clean Monitor screen appears.
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6. Alarms
6.1 Introduction
The ViSi Mobile Monitoring System provides a comprehensive alarm system that alarms on changes to the
patient’s physiologic status (alarms) and technical alarms (alerts).
The system provides default alarm limits for physiological alarms. The clinician can manually manage the
alarm limits for each patient to provide individualized care.
Technical alarms (alerts) are provided to notify the clinician of situations that may impede the ability to
monitor your patient.
6.1.1 System Alarm Management
During the installation of the ViSi Mobile Monitoring System, alarm configurations may be modified to
conform to the alarm policies set by the clinical care unit.
General Alarm Management Rules
The following general alarm management rules pertain to the ViSi Mobile Monitoring System:
•
•
•
All ViSi Mobile Monitoring System alarms conform to IEC 60601-1-8.
Alarms and alerts originate from the ViSi Mobile Monitor (worn by the patient).
Silencing/acknowledging a patient’s alarm or alert suspends the audio tones for up to 2 minutes.
When a new alarm/alert occurs during the 2 minute silenced/acknowledged period, the new alarm/
alert will be immediately annunciated.
Note: When the clinician silences/acknowledges an alarm/alert, all active alarms/alerts in progress
will also be silenced/acknowledged for the 2 minutes. The clinician does not need to silence/
acknowledge each alarm/alert individually.
• Alarm annunciation may be turned off for an indefinite period of time. This disables the
annunciation of alarms and alerts on both the ViSi Mobile Monitor and the Remote Viewer for the
“off” duration. Turning the alarms off must be done directly from the ViSi Mobile Monitor (worn
by the patient), however, alarms may be turned back on from either the ViSi Mobile Monitor or the
Remote Viewer.
• Alarm annunciation may be paused for 2 minutes. This disables the annunciation of alarms and
alerts on both the ViSi Mobile Monitor (worn by the patient) and the Remote Viewer for the
paused duration. Pausing the alarms must be done directly from the ViSi Mobile Monitor (worn by
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Introduction
the patient), however, alarms may be resumed from either the ViSi Mobile Monitor or the Remote
Viewer.
Note: When the annunciation of alarms/alerts has been turned off or paused, certain important
alarms and alerts will continue to annunciate (known as break-through alarms and alerts).
These are generally equipment alerts that inhibit the ability to monitor the patient
appropriately.
Note: When alarms/alerts are paused, alarms/alerts currently in progress will no longer be
annunciated. The annunciation of any new alarms/alerts will be disabled for the 2 minute
duration.
Note: When alarms/alerts are silenced/acknowledged, the audio tone will be silenced. Any new
alarms/alerts occurring during the 2 minute silenced/acknowledged duration will be
immediately annunciated.
In Network Rules
When the ViSi Mobile Monitor is in network and connected to the ViSi Mobile Remote Viewer:
•
When the ViSi Mobile Monitor is connected to the Remote Viewer, the audio alarm and alert tones
will be deferred from the Monitor to the Remote Viewer, for a pre-configured length of time.
Note: Audio tones for life threatening alarms will not be delayed.
• Alarms/alerts may be silenced/acknowledged from either the ViSi Mobile Monitor or Remote
Viewer.
Note: Silencing/acknowledging a life threatening alarm directly from the ViSi Remote Viewer will
only silence/acknowledge the alarm on the Remote Viewer. To silence/acknowledge the life
threatening alarm on the ViSi Mobile Monitor, the clinician must silence/acknowledge the
alarm directly from the Mobile Monitor (worn by the patient).
• When alarm annunciation has been turned off, alarm annunciation may be turned back on from
either the ViSi Mobile Monitor or Remote Viewer. Turning alarm annunciation off can only be
done directly from the ViSi Mobile Monitor (worn by the patient).
• When alarm annunciation has been temporarily paused, alarm annunciation may be resumed from
either the ViSi Mobile Monitor or Remote Viewer. Pausing alarm annunciation can only be done
directly from the ViSi Mobile Monitor (worn by the patient).
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Physiological Alarms (Alarms) / Technical Alarms
6.2 Physiological Alarms (Alarms) / Technical Alarms
(Alerts) Summary
6.2.1 Responding to Alarms/Alerts
Silencing Audible Alarms/Alerts from ViSi Remote Viewer
Where to Respond to Alarm
Priority
Type of Alarm
Life Threatening
Silence
Button
Audio Tones
Remote Viewer
(At Clinician’s Station)
Mobile Monitor
(At Patient)
Silenced at the Remote
Viewer for 2 minutes.
Audible continues
on Mobile Monitor
until silenced on
Mobile Monitor.
Beep
Beep
Beep
- Pause Beep
Beep
Silence at Remote Viewer or Mobile Monitor.
Beep
Beep
Beep
- Pause Beep
Beep
Continues on Mobile
Monitor
LATCHED
High
(2 minute audible silenced on both Remote
Viewer and Mobile Monitor.)
Non-Latched
Alerts
(High / Medium)
Silence at Remote Viewer or Mobile Monitor.
(2 minute audible silenced on both Remote
Viewer and Mobile Monitor.)
Beep
Beep
- Pause -
Non-Latched
Alerts
(Low)
Non-Latched
Visual Only - No Sound
No audio
tones.
Acknowledge at the Remote Viewer or Mobile
Monitor.
(Acknowledged for 2 minutes at both the
Remote Viewer and Mobile Monitor.)
Latched:
The alarm remains in an active state until the clinician silences/acknowledges the alarm on
the ViSi Monitor.
Non-Latched:
Alarms/alerts can self-correct themselves without any action by the clinician.
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Physiological Alarms (Alarms) / Technical Alarms (Alerts) Summary
6.2.2 Managing Alarm/Alert Annunciations
Action
Pause Alarms/
Alerts
Action Button
Duration
Allow Where
Effects
N/A
2 Minutes
May only be paused
from the ViSi Mobile
Monitor.
Annunciation disabled at
both the ViSi Monitor and
Remote Viewer.
N/A
ViSi Mobile Monitor and
Remote Viewer.
Annunciation resumed at
both the ViSi Mobile
Monitor and Remote Viewer.
Indefinitely
May only be turned off
from the ViSi Mobile
Monitor.
Annunciation disabled at
both the ViSi Monitor and
Remote Viewer.
N/A
ViSi Mobile Monitor and
Remote Viewer.
Annunciation turned on at
both the ViSi Mobile
Monitor and Remote Viewer.
Resume Alarms/
Alerts
Turn Alarms/
Alerts Off
Turn Alarms/
Alerts On
N/A
Annunciation: Refers to the audible and visual display of alarms/alerts.
Note: When multiple alarms and alerts occur simultaneously, the message text will only display
messages associated with the highest alarm severity. The vital measurements will display all
existing alarms, regardless of their severity.
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Responding to Physiological Alarms (Alarms)
6.3 Responding to Physiological Alarms (Alarms)
A responsible clinician must be within audible range of the ViSi Mobile
Monitor at all times.
6.3.1 To Silence/Acknowledge Life Threatening Severity Alarms
Life threatening severity alarms require urgent clinician response at the bedside.
Symbol
Annunciation Color
White / Red
Audio Tone
BBB P BB P BBB P BB...
B - Beep / P - Pause
Duration (ms)
Spacing (ms)
100
50
Silence/Acknowledge
Alarm
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Responding to Physiological Alarms (Alarms)
To silence/acknowledge the alarm, touch Silence/Acknowledge Alarm button
- or -
Touch the Alarm Status.
The alarm is silenced/acknowledged and the “Silenced/Acknowledged” symbol and countdown
will be displayed. After the 2 minute countdown has expired, the alarm will be re-annunciated.
Silenced/Acknowledged
symbol and countdown
Note: When a Life Threatening alarm occurs and the alarming condition resolves itself before a
clinician is able to respond, visual and audio indications of the life threatening alarm
continue to annunciate until the clinician silences the alarm.
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Responding to Physiological Alarms (Alarms)
6.3.2 To Silence High Severity Alarms
High severity alarms require immediate clinician response at the bedside.
Symbol
Annunciation Color
Red
Audio Tone
BBB P BB P BBB P BB...
B - Beep / P - Pause
Duration (ms)
Spacing (ms)
200
100
Silence/Acknowledge
Alarm
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Responding to Physiological Alarms (Alarms)
To silence/acknowledge the alarm, touch Silence/Acknowledge Alarm button
- or -
Touch the Alarm Status.
The alarm is silenced/acknowledged and the silenced/acknowledged symbol and countdown will
be displayed.
Silenced/Acknowledged
symbol and countdown
Note: When a high alarm occurs and the alarming condition resolves itself before a clinician is able
to respond, the high alarm message will be displayed (in gray) for up to 5 minutes in the
message area. This serves as a reminder to the clinician that a high alarm has occurred.
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Responding to Equipment Alarms (Alerts)
6.4 Responding to Equipment Alarms (Alerts)
6.4.1 To Silence/Acknowledge Alerts (All Severities)
Equipment alerts are used when the ability to monitor the patient and detect a patient’s physiological
alarms may be affected.
Symbol
Annunciation
Color
Severity
Cyan
High
Medium
Low
Duration
(ms)
Spacing
(ms)
BBP
B - Beep / P - Pause
There will be a 15 second pause
after each sequence.
250
250
BBP
B - Beep / P - Pause
There will be a 15 second pause
after each sequence.
250
250
No audio tones.
N/A
N/A
Audio Tone
Silence/Acknowledge
Alarm
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Responding to Equipment Alarms (Alerts)
To silence/acknowledge the alert, touch Silence/Acknowledge Alarm button
- or -
Touch the Alert Status.
The alert is silenced/acknowledged and the silenced/acknowledged symbol and countdown will be
displayed.
Silenced/Acknowledged
symbol and countdown
Note: When an alert condition (of any severity) resolves itself before the clinician is able to
respond, the alert condition will no longer be annunciated.
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Managing Alarm Annunciations
6.5 Managing Alarm Annunciations
6.5.1 Pause / Resume Alarms
When alarms are paused, there is no notification of a potentially clinically
significant change in the patient's vital signs. Observe the patient by other
means when alarms are paused.
To pause the alarms
Pause Alarms
From the Vital Signs screen, touch Pause Alarms.
The alarms will be paused for 2 minutes.
When paused, the words ALARMS PAUSED are displayed at the top of the screen and an ALARMS
PAUSED icon is displayed in the lower right corner of the screen.
Alarms are paused
Remaining “Paused” duration
Note: When the clinician logs out of the ViSi Mobile Monitor, the alarms will automatically be
resumed.
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Managing Alarm Annunciations
To Resume Alarms
When alarms are paused, the annunciation of any existing and new alarm will be disabled at both the ViSi
Mobile Monitor and Remote Viewer. Alarms may be resumed from either Mobile Monitor or Remote
Viewer.
Resume alarms
Alarms are currently paused.
Remaining “Paused” duration.
To resume alarm annunciation, touch the Resume button.
- or -
Touch the AlarmStatus.
The alarms are resumed and will annunciate on both the ViSi Mobile Monitor and Remote Viewer.
Note: Alarm annunciation will resume at both the ViSi Mobile Monitor and Remote Viewer.
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Managing Alarm Annunciations
6.5.2 Turn Alarm Annunciation On / Off
When alarms are turned OFF, there is no notification of a potentially
clinically significant change in the patient's vital signs. Observe the patient
by other means when alarms are turned OFF.
To turn all alarms off
1. Touch Menu on the Vital Signs screen.
The Menu screen appears.
2. Touch Alarms Settings.
The Patient Alarm Limits screen appears. Alarm limit settings are only displayed for the connected
sensors.
Auto Set
Turn Alarms Off
Return to
Previous Screen
All Sensors Connected
3. To turn all alarms off, touch Turn Alarms Off.
The Turn Alarms Off confirmation screen appears.
101
Managing Alarm Annunciations
4. Touch Confirm to confirm that you want to turn all alarms off.
-orTouch Cancel to leave the alarms turned on.
If cancelled, the system returns to the Patient Alarm Limits screen and the alarms remain turned
on.
If confirmed, the alarms are turned off and the Vital Signs screen appears. The words ALARMS
OFF are displayed at the top of the screen and an ALARMS OFF icon is displayed in the lower
right corner of the screen.
ALARMS OFF Icon
(flashes on/off)
Note: Alerts that indicate the Monitor is unable to measure a vital sign (such as ECG Lead Fail)
can not be turned off.
To Turn On Alarm Annunciation
When alarms are turned off, the annunciation of any existing and new alarm will be disabled at both the
ViSi Mobile Monitor and Remote Viewer. Alarms may be turned back on directly from the Remote
Viewer.
Turn alarms
back on
Alarms are currently
turned off
(flashes on/off)
102
Managing Alarm Annunciations
To turn the alarm annunciation back on, touch the Turn Alarms On button.
- or -
Touch the Alarm Status.
The alarms will be turned back on.
Note: Alarm annunciation will be turned on at both the ViSi Mobile Monitor and Remote Viewer.
103
Manage Alarm Limits
6.6 Manage Alarm Limits
Alarm limits for each vital sign parameter are predefined and turned on automatically whenever a sensor is
connected to the patient and to the Monitor. Sometimes it is desirable to adjust the alarm limits to meet a
patient’s monitoring requirements.
The Auto Set function sets alarm limits based on the current vital signs measurements for all connected
sensors. If the alarms are turned off prior to initiating the Auto Set process, the alarms are turned back on
when the new alarm limits are confirmed.
Once new alarm limits are confirmed, they cannot be changed back to the
original pre-set limits. Once Auto Set is selected, review the newly
calculated alarm limits carefully before deciding to confirm or cancel the new
alarm limits.
To change alarm limits using Auto Set
1. Touch Menu on the Vital Signs screen.
2. Touch Alarms Settings.
The Patient Alarms Settings screen appears.
Note: Alarm limit settings are only displayed for the currently monitored vital signs.
3. Touch Auto Set.
Alarm limits for all currently monitored vital signs are recalculated based on the current vital
signs measurements. The Confirm New Alarm Limits screen appears.
104
Manage Alarm Limits
Note: Upper and lower alarm limits cannot be set for TEMP.
4. Touch Confirm to confirm that you want to accept the new alarm limits.
-orTouch Cancel to return to the Patient Alarm Limits screen.
The previous alarm limits are retained.
Once confirmed, the system returns to the Vital Signs screen.
5. Navigate to the Patient Alarm Limits screen to review the current alarm limits.
When selecting Auto Set, alarm limits are calculated to clinically relevant values based on the patient’s
present condition. Auto Set is not available for SpO2 and temperature. The minimum and maximum
values to which auto set will adjust the limits are listed in the table below.
Auto Set Alarm Limits
Auto Set Limit Calculation
(based on current reading)
Alarm
Limit
Default Limits
Auto Set Range
Heart Rate (BPM)
High
140
90-160
HR x 0-66 + 53.3
Low
40
30-80
HR x 0.54 + 13.6
High
140
90-160
PR x 0-66 + 53.3
Low
40
30-80
PR x 0.54 + 13.6
High
190
160-240
BP x 0.75 + 60.0
Low
90
60-120
BP x 0.71 + 17.1
High
120
95-150
BP x 0.60 + 60.0
Low
40
30-90
BP x 0.72 + 8.3
High
35
12-40
RR x 0.69 + 12.5
Low
5-8
RR x 0.28 + 3.6
Pulse Rate (BPM)
BP Systolic (mmHg)
BP Diastolic (mmHg)
Respiration (BR/M)
Note: There is no manual way set individual alarm limits. Auto Set recalculates all alarm limits.
105
Manage Alarm Limits
Auto Set Alarm Limits
(Heart Rate / Respiration)
106
Manage Alarm Limits
Auto Set Alarm Limits
(Blood Pressure)
107
Manage Alarm Limits
6.6.1 Testing Alarms
Whenever a sensor is connected to the Monitor, a self-test of that sensor is initiated automatically to verify
the sensor is in good working order. If the sensor and Monitor speaker are in good working order, you will
hear a double beep.
Do not cover the microphone of the Monitor during the self-test
108
7. User Maintenance
7.1 Introduction
This section of the manual outlines routine maintenance that should be performed by the user. The ViSi
Mobile Monitoring System is designed for stable operation over long periods of time and, under normal
circumstances, should not require technical maintenance beyond that described in this section. However, it
is recommended that routine maintenance (including checking components for damage), calibration, and
safety checks be performed at least once a year as required by your facility administration practice.
Routine testing of functionality, alarms and alerts can be verified using standard electronic patient
simulators.
In the event any component needs to be returned to Sotera Wireless, Inc; contact the Sotera Wireless Inc.
Customer Service Department or the Sotera Wireless representative in your area. Prior to shipping, ensure
the returned components have been properly disinfected.
The ViSi Mobile Cuff Module contains an air filter that should be inspected by the Bio Med in accordance
to the service schedule as described in the Technical Reference Manual. The ViSi Mobile Disposable Cuff
should be used on one and only one patient.
For more technical information, refer to the ViSi Mobile Monitoring System Technical Manual.
The ViSi Mobile Monitoring System components should only be serviced by
Sotera Wireless, Inc. technicians or authorized service providers.
7.2 Cleaning and Disinfection
The ViSi Mobile Monitor, Cuff Module, Chest Sensor Cable and Thumb Sensor require cleaning and
disinfection prior to reuse on a different patient.
To prevent possible cross-contamination, properly clean and disinfect all
reusable components between patients.
Do not clean the ViSi Mobile Monitor with detergents while worn by the
patient.
109
Cleaning and Disinfection
Do not clean the ViSi Mobile Monitor while it is plugged into the ViSi Mobile
Charger.
Do not clean the ViSi Mobile Cuff Module while it is plugged into the ViSi
Mobile Charger.
Do not apply liquid to the ViSi Mobile Cuff Module. To clean, use a damp
cloth.
Ensure the sensor connector contacts are thoroughly dried to prevent
possible malfunction.
Thumb sensors which are saturated with fluid should be allowed to air dry
thoroughly before re-use.
Prior to cleaning and disinfecting:
1. Pre-clean at the point of use to remove and prevent drying of soil and contaminants.
2. Ensure all components are disconnected, including the ViSi Mobile Monitor from the Wrist Cradle
and Thumb Sensor from the Thumb Cradle.
After cleaning and disinfection is complete, inspect the System components for wear, damage,
discoloration, fraying and cracking. Replace any System components that show evidence any of these
anomalies.
110
Inspecting Equipment and Accessories
To clean the ViSi Mobile Monitoring System components
1. Hand wash the System components using mild soap or detergent and water. Use moistened lintfree cloths to remove residual cleaner.
A soft-bristled brush may be used for heavily soiled areas, where needed.
2. Dry the System components using a lint-free cloth.
3. Visually examine each System component to ensure all soil contaminants have been removed.
4. Repeat the above cleaning process as required.
To disinfect the ViSi Mobile Monitoring System components
Do not use abrasive cleaning agents or organic solvents on any of the ViSi
Mobile Monitoring System components.
Use only recommended cleaning / disinfecting agents to prevent damage to
the device and components.
Do not autoclave the ViSi Mobile Monitor, its components, or accessories.
Do not use excessive amounts of liquid when cleaning the ViSi Mobile Chest
Sensor Cable or the ViSi Mobile Thumb Sensor.
1. Disinfect all System components by wiping components with a lint-free cloth moistened with
isopropyl alcohol.
2. Dry thoroughly using a lint-free cloth.
7.3 Inspecting Equipment and Accessories
After cleaning and disinfecting, you should visually inspect the ViSi Mobile Monitoring System
components:
1. For each component, examine the exteriors for cleanliness and general physical conditions.
Ensure the housings are not cracked or broken, that everything is present, there are no spilled
liquids and no signs of abuse.
2. Inspect all component cables for damage. Check their strain relief for general condition. Ensure
there are no breaks in the insulation. If any cables show signs of damage, do not use.
3. Inspect all disposable accessories (Wrist Cradle, Cuff, Thumb Strap, Securements, etc). If any
show signs of damage or pre-use, do not use.
111
Product Disposal
7.4 Product Disposal
To avoid contaminating or infecting personnel, the environment or other
equipment, make sure you disinfect and decontaminate the ViSi Mobile
Monitoring System components appropriately before disposing of them in
accordance with your country’s laws for equipment containing electrical and
electronic parts.
The ViSi Mobile Monitoring System components are designated for separate collection at an appropriate
collection point. Do not dispose of as household waste. Refer to your facility’s procedures.
After patient use, the disposables from the ViSi Patient Kit may contain biohazard materials.
Disposables from the ViSi Patient Kit should be disposed of per your facility’s procedures for bio-hazard
materials.
Contact the Sotera Wireless Inc. Customer Service Department or the Sotera Wireless representative in
your area to obtain additional information about cleaning and disinfecting the ViSi Mobile Monitoring
System components or product disposal.
112
8. Troubleshooting
8.1 Introduction
The ViSi Mobile Monitoring System is designed to alert you to technical issues that may occur while
monitoring a patient’s vital signs.
The following tables provide troubleshooting solutions to potential problems that may be encountered
while monitoring a patient
113
ViSi Mobile Monitor
8.2 ViSi Mobile Monitor
Problem
Potential Cause
Solution
The screen is blank
The display is in Quiet
Monitoring Mode.
Touch the screen with one finger for two
seconds to activate display.
Plug in a sensor to initiate monitoring.
The display is in Hibernation
Mode.
Plug in a sensor to initiate monitoring.
The battery charge is too low.
Disconnect all sensors from the Monitor,
clean the Monitor, and place it in the
Charger.
Plug is oriented with the
connector contacts facing
downwards.
Orient the Plug so that the connector
contacts are facing upwards.
Trying to Plug into wrong end of
the Monitor.
Only the Thumb Sensor is designed to be
Plugged into the rounded end of the
Monitor. All other sensors can be Plugged
into any port on the flat end of the
Monitor.
Problem
Potential Cause
Solution
No response to touching any
buttons
Touching the screen with more
than one finger.
Touch the button with only a single
finger.
Button is not an active button.
Active buttons are those with borders, and
are not dimmed in appearance compared
to other buttons.
Touching the screen with a pen
or stylus.
Touch the button with only a single
finger.
Screen is locked.
Touch the Unlock button and enter the
correct PIN.
Access denied due to entering
the wrong PIN code.
Enter the correct PIN code.
Sensors won’t Plug into the
Monitor
8.2.1 Screen Access
Cannot access the Vital Signs
screen
114
ViSi Mobile Chest Sensor Cable
Problem
Potential Cause
Solution
Patient has accessed the
monitoring functions
Screen was not locked after last
clinician interaction.
•
•
Patient guessed PIN correctly.
•
•
Make sure to lock the screen each
time you complete your interactions.
Remind the patient that this is a medical device, and that tampering may
result in missing important clinical
events.
Define appropriate PIN codes (not
0000 for example).
Remind the patient that this is a medical device, and that tampering may
result in missing important clinical
events.
8.3 ViSi Mobile Chest Sensor Cable
Problem
Potential Cause
Solution
Chest sensor Cable is too short
to Plug into the Monitor
Monitor is oriented in the wrong
direction.
Make sure that the flat end of the Monitor
is oriented towards the elbow.
The Chest Sensor Cable is
secured to the side of the chest
opposite the arm with the
Monitor.
Secure the Chest Sensor Cable midway
between the sternum and the shoulder of
the same arm that the Monitor is on.
ECG electrodes not connected to
lead wires.
Ensure that the lead wires are snapped
securely onto the ECG electrodes.
ECG electrodes not firmly
attached to the patient’s chest.
Ensure that the ECG electrodes are
securely attached to the chest; ECG
electrode sites are clean and free of excess
hair.
ECG electrode gel is dry.
Replace ECG electrodes.
Broken/damaged lead wires.
Replace damaged Chest Sensor Cable.
Chest Sensor Cable not securely
Plugged into the Monitor.
Make sure that the Chest Sensor Cable is
securely Plugged into the Monitor.
A lead-wire or sensor problem is
affecting the measurement.
If the problem persists, replace the ECG
electrodes and/or Chest Sensor Cable.
No HR numeric
HR displays “XX”
115
ViSi Mobile Chest Sensor Cable
Problem
Potential Cause
Solution
HR is erratic
ECG electrodes are not all the
same.
Use all the same ECG electrode type,
size, materials, and manufacturer.
ECG electrode gel is dry.
Replace ECG electrodes.
ECG electrodes not firmly
attached to the patient’s chest.
Check the ECG electrodes are securely
attached to the chest; ECG electrode sites
are clean and free of excess hair.
No ECG waveform
See No HR numeric above.
See No HR numeric above.
ECG waveform too small
Using a 3-lead Chest Sensor
Cable:
Lead II has a low amplitude.
•
Lead II only available with a 3lead Chest Sensor Cable.
•
Using a 5-lead Chest Sensor
Cable: Selected lead has low
amplitude.
5-lead Chest Sensor Cable: select a
different lead to view.
ECG electrodes not firmly
attached to the patient’s chest.
Ensure that the ECG electrodes are
securely attached to the chest; ECG
electrode sites are clean and free of excess
hair.
ECG electrode gel is dry.
Replace ECG electrodes.
See No HR numeric above.
See No HR numeric above.
The Monitor is not capable of
measuring RESP.
See Bio Med.
RESP displays “XX”
A lead-wire or sensor problem is
affecting the measurement.
If the problem persists, replace the ECG
electrodes and/or Chest Sensor Cable.
RESP is erratic
ECG electrodes not firmly
attached to the patient’s chest.
Ensure that the ECG electrodes are
securely attached to the chest; ECG
electrode sites are clean and free of excess
hair.
ECG electrode gel is dry.
Replace ECG electrodes.
The Chest Module sensor is
placed on the patient with the
Temperature Sensor facing away
from the patient.
Place the Chest Module sensor on the
patient such that the Temperature Sensor
is in direct contact with the patient’s
chest.
Sensor is not attached to the
patient’s chest.
Secure the Chest Sensor Cable to the
chest. Make sure that a change in position
does not affect the sensor’s contact with
the skin.
The Temperature Sensor may
have failed.
If the problem persists, replace the Chest
Sensor Cable.
ECG waveform is noisy; looks
like pacer indicators in the
waveform
No RESP numeric
No TEMP numeric
TEMP displays “XX”
116
Select alternate ECG electrode sites;
prepare skin sites; connect lead wires
to new ECG electrodes and place on
the chest.
Replace 3-lead Chest Sensor Cable
with 5-lead Chest Sensor Cable.
ViSi Mobile Chest Sensor Cable
Problem
Potential Cause
Solution
TEMP is erratic
Chest Sensor Cable is not in
contact with the skin completely/
securely.
Secure the Chest Sensor Cable to the
chest. Make sure that a change in position
does not affect the sensor’s contact with
the skin.
Skin is not clean and dry.
Clean and dry the skin thoroughly and
secure the Chest Sensor Cable to the
chest.
117
ViSi Mobile Thumb Sensor
8.4 ViSi Mobile Thumb Sensor
Problem
Potential Cause
Solution
Sensor cable too short to Plug
into Monitor
Monitor is oriented in the wrong
direction.
Make sure that the rounded end of the
Monitor is oriented towards the hand.
Thumb sensor is routed wrong.
Make sure the cable is routed around the
outside of the thumb.
Broken/damaged Thumb Sensor.
Replace the Thumb Sensor
Something is blocking the optics
or detector in the Thumb Sensor.
Make sure nothing is blocking the optics
or detector.
Thumb Sensor not secured in the
Thumb Sensor Cradle.
Place the Thumb Sensor securely in the
Thumb Sensor cradle.
Thumb Sensor not secured to the
base of the thumb.
Secure the Thumb Sensor to the base of
the thumb.
Thumb Sensor not securely
Plugged into the Monitor.
Make sure that the Thumb Sensor is
securely Plugged into the Monitor.
SpO2 displays “XX”
A sensor problem is affecting the
measurement.
If the problem persists, replace the
Thumb Sensor.
SpO2 is erratic
Something is partially blocking
the optics or detector in the
Thumb Sensor.
Make sure nothing is blocking the optics
or detector.
Thumb Sensor not secured to the
base of the thumb.
Secure the Thumb Sensor to the base of
the thumb.
Thumb Sensor is not in the
correct location.
Reorient the Thumb Sensor at the base of
the thumb and secure with the Thumb
Wrap.
Thumb Strap is too tight.
Loosen the Thumb Strap making sure that
it is still secure.
No SpO2 numeric
118
ViSi Mobile Cuff Module
8.5 ViSi Mobile Cuff Module
Problem
Potential Cause
Solution
Cuff Module cable is too short to
Plug into Monitor
Monitor is oriented in the wrong
direction.
Make sure that the flat end of the Monitor
is oriented towards the arm.
Cuff Module is on the arm
opposite the Monitor.
Place the Cuff Module on the same arm
that the Monitor is on.
Battery charge is too low.
Replace the Cuff Module.
Cuff Module not Plugged
securely into the Monitor.
Make sure that the Cuff Module is
Plugged securely into the Monitor.
Not set up for automatic
measurements.
From the NIBP Settings screen, select an
automatic interval.
The time from the last
measurement exceeds the period
of time to display a
measurement.
Initiate a measurement from the Vital
Signs screen.
Measurements were not taken at
the same time.
Measurements are taken at the same time.
Measurements were taken on
different arms.
The BP in both arms is the same,
sometimes there is a difference between
arms.
Different size cuffs were used.
Ensure the BP cuff size is the same on
both arms, and the correct size for the
arm.
Both arms were not at the same
level when the BP was
measured.
The arms are positioned at the same level
relative to the heart.
No NIBP measurement
NIBP measurement doesn’t
match an auscultatory
measurement
119
ViSi Mobile Cuff Module
Problem
Potential Cause
Solution
LED on Cuff Module displays
red when in the Charger.
Voltage level has exceeded
expectation.
•
•
Current level has exceeded
expectation.
•
•
Over temperature protection
current temperature has
exceeded expectation.
120
•
•
Remove Cuff Module from the Charger.
Report the problem to Sotera Wireless Inc. Customer Service Department or the Sotera Wireless
representative in your area.
Remove Cuff Module from the Charger.
Report the problem to Sotera Wireless Inc. Customer Service Department or the Sotera Wireless
representative in your area.
Remove Cuff Module from the Charger.
Report the problem to Sotera Wireless Inc. Customer Service Department or the Sotera Wireless
representative in your area.
ViSi Mobile Battery Charger
8.6 ViSi Mobile Battery Charger
Problem
Potential Cause
Solution
Batteries in the Monitor and
Cuff Module do not charge
The Monitor and Cuff Module
are not securely seated in the
Charger.
Make sure that the Monitor and Cuff
Module are securely seated in the
Charger.
The monitor and Cuff Module are
designed to fit into the Charger in one
direction.
The Charger is not completely
Plugged in to the wall socket.
•
•
AC Adapter is not Plugged into
the Charger.
•
Make sure that the Plug is securely
Plugged into an active wall socket
and there is a green light on the Battery Charger.
Make sure that the power cord is not
damaged.
Plug the AC Adaptor into the Charger.
121
General Troubleshooting
8.7 General Troubleshooting
8.7.1 Connectivity Lost
Problem
Potential Cause
Solution
On the ViSi Mobile Remote
Viewer, “XX” appears where all
vital sign measurements should
be displayed.
The patient wearing the ViSi
Mobile Monitor has moved
outside of the wireless network
area.
Move the patient back into the wireless
network area.
On the ViSi Mobile Remote
Viewer, all patients have
disappeared from the Care Unit
area.
The network cable has been
disconnected from the ViSi
Mobile Remote Viewer.
Reconnect the network cable to the
Remote Viewer.
8.7.2 Alarms and Alerts
If you test the speaker at the ViSi Mobile Remote Viewer and the tone does
not sound or it is not loud enough, immediately contact a biomedical
engineer. The test indicates how alarm and alert tones sound at the Remote
Viewer. If the sound is inadequate, clinicians could miss alarms and alerts.
Problem
Explanation
I acknowledge an alarm at the ViSi Mobile Remote
Viewer, but the audio tone still occurs at the ViSi Mobile
Monitor.
•
•
An alarm occurs, but the audio tone stops before I
acknowledge it.
•
•
Life-Threatening alarms latch at the ViSi Mobile
Monitor until they are acknowledged there, even
if the alarm condition resolves.
Certain alerts (such as a sensor being disconnected) continue to sound at the ViSi Mobile
Monitor until you acknowledge the alert at the
Monitor.
If an alarm or alert condition resolves before it is
acknowledged, the audio tones stops.
If the alarm condition was a high-level severity,
the alarm message will remain visible (in gray)
for five minutes.
I stop monitoring a patient at the ViSi Mobile Monitor,
according to procedure, but a MONITOR STOPPED
alert still appears on the ViSi Mobile Remote Viewer.
The alert informs all clinicians who are remotely
monitoring the patient that monitoring has stopped.
Acknowledge the alert to remove the patient from the
care unit.
My patient had a vital sign alarm. I did not acknowledge
the alarm, but I removed the sensor from the patient. The
vital sign alarm continued.
You must acknowledge the vital sign alarm, even if
the sensor is removed.
122
General Troubleshooting
Problem
Explanation
An alert with the
icon and PATIENT
TAMPERING message occurred. What does it mean?
Someone has unsuccessfully tried to log in to the ViSi
Mobile Monitor five or more times.
The visual indications go away after the alert is
acknowledged and after a clinician successfully logs
in at the Monitor.
When an alarm or alert occurs, the audio annunciation is
heard on the ViSi Remote Viewer, but there is no audio
on the ViSi Mobile Monitor.
Most alarms and alerts will audible annunciate at the
ViSi Remote Viewer before they audibly annunciate
at the ViSi Mobile Monitor.
This is to minimize disturbing the patient.
Sometimes if more than one alarm or alert occurs for a
patient at the same time, one or more of the messages
don’t show.
•
•
•
•
If the alarms or alerts are the same severity level,
the messages will cycle through.
Messages for alarms or alerts that are at a lower
severity level will not be displayed.
If alarms and alerts occur simultaneously, only
messages associated with the alarms will be displayed.
Other visual indications usually show for lower
level alarms and alerts.
Sometimes I acknowledge an alarm or alert, and all
alarm or alert indications go away. The audio tone never
returns.
Some alarms and alerts are acknowledged
permanently.
At the ViSi Mobile Monitor, I set all alarming to OFF, or
I set all alarming to PAUSED. But some alarms and
alerts continue to be annunciated.
Some important alarms and alerts (such as sensor
being disconnected) will continue to annunciate even
when all alarms are turned off, or paused.
When an alarm or alert occurs, the ViSi Mobile Remote
Viewer does not sound an audio tone, or the tone is not
loud enough.
•
•
•
The ViSi Mobile Remote Viewer displays a
CONNECTIVITY LOST alert, what does it mean?
Some alerts do not have an audio tone. When an
audio tone is associated with an alarm or alert, the
Speaker Test button will animate.
When an audio tone is expected, but not present
(or not loud enough), immediately contact a Bio
Med.
The speaker volume for the ViSi Mobile Remote
Viewer can be tested at any time (see section ViSi
Remote Viewer Audio Test on page 67).
The ViSi Mobile Monitor is no currently connected to
the network.
123
ViSi Mobile Remote Viewer
8.8 ViSi Mobile Remote Viewer
8.8.1 Setting Alarm Limits
Problem
Explanation
When I try to adjust individual limits in the Alarm
Settings pane, I cannot go past certain limit values.
You cannot set limits beyond the care unit alarm
limits.
When I adjust an upper limit, the lower limit also
changes, or vice versa.
If you adjust a vital sign limit to equal the opposite
limit, the opposite limit adjusts. Upper and lower
limits for a vital sign cannot be the same value.
The alarm limits on the ViSi Mobile Monitor and the
limits at the ViSi Mobile Remote Viewer do not match.
The alarm limits were set on the ViSi Mobile Monitor
while the Monitor was not connected to the network.
The new limits will not be communicated back to the
ViSi Remote Viewer until the Monitor reconnects to
the network.
The alarms were changed on the ViSi Remote Viewer
but before the new alarm limits were communicated
to the ViSi Mobile Monitor, the Monitor moved out of
network.
The limits on the Monitor are the operating limits at
all times.
124
9. Specifications
9.1 Introduction
This section provides specifications regarding measurement ranges, accuracy levels and environmental
operating conditions for the ViSi Mobile Monitoring System.
Do not use the ViSi Mobile Monitoring System in neonatal or pediatric
patients under the age of 12 years since the System has not been tested for
these patient groups.
125
Vital Sign Measurements
9.2 Vital Sign Measurements
9.2.1 Heart Rate
Heart Rate
Display Range
0 to 240 BPM
Accuracy Range
30 to 240 BPM
Accuracy
3 BPM or ±3% of reading, whichever is greater
Resolution
1 BPM
Pacemaker
•
•
•
•
Pacemaker Pulse Rejection
Without Overshoot
The monitor detects and rejects pacemaker impulses in accordance with
AAMI EC13:2002
Performs heart rate calculations on a patient with a pacemaker
Will not recognize a pacemaker impulse as a QRS
Displays pacer markers on ECG waveforms
Tested per EC13:2002, 4.1.4.1:
Pulse Rejection Range:
Amplitude from ±2 mV to ±700 mV
Pulse Width from 0.1 ms to 2 ms
Note:
Amplitude limited to 660mV for
pulse widths from 1.5 to 2.0ms
Indicated Heart Rate:
Pacemaker Pulse Rejection
With Overshoot
Ventricular Pacing:
Case (a): 0 BPM
Case (b): 60 BPM
Case (c): 30 BPM
Atrial / Ventricular Pacing:
Case (a): 0 BPM
Case (b): 60 BPM
Case (c): 30 BPM
Tested per EC13:2002, 4.1.4.2, Method A:
Pulse Rejection Range:
Amplitude from ±2 mV to ±700 mV
Pulse Width from 0.1 ms to 2 ms
Note:
Amplitude limited to 660mV for
pulse widths from 1.5 to 2.0ms
Note: For pulse width > 1.0mS,
recovery time limited to 25mS.
Indicated Heart Rate:
126
Ventricular Pacing:
Case (a): 0 BPM
Case (b): 60 BPM
Case (c): 30 BPM
Atrial / Ventricular Pacing:
Case (a): 0 BPM
Case (b): 60 BPM
Case (c): 30 BPM
Vital Sign Measurements
Heart Rate
Pacer Pulse Detector
Rejection of Fast ECG
Signals
Tested per EC13:2002, 4.1.4.3:
• Minimum Slew Rate: 25 V/s
Defibrillation Response
•
•
•
Defibrillator protected
Displays HR measurement < 30 seconds after a defibrillation event
Displays an ECG waveform < 10 seconds after a defibrillation event
Note: Defibrillation events may be implanted or external.
Note: Defibrillation recovery is dependent upon using proper
disposable electrodes. Use only Ag-AgCl disposable
electrodes.
T-Wave Rejection
Tested per EC13:2002, 5.1.2.1:
• T-waves up to 1.2 mV in amplitude:
• T-waves not detected, no change in indicated heart rate.
Heart Rate Averaging
Tested per EC13:2002, 5.1.2.1 d):
• 10 second moving average
Heart Rate Accuracy and
Response to Irregular
Rhythm
Tested per EC13:2002, 5.1.2.1 e):
• Waveform 3a: 80 BPM
• Waveform 3b: 30 BPM
• Waveform 3c: 120 BPM
• Waveform 3d: 60 BPM
Change in Heart Rate
Tested per EC13:2002, 5.1.2.1 f):
• 80 BPM to 120 BPM: < 8 seconds
• 80 BPM to 40 BPM: < 8 seconds
Time to Alarm for Cardiac
Standstill
Tested per EC13:2002, 4.2.8.4:
• < 10 seconds
Time to Alarm for
Tachycardia
Tested per EC13:2002, 5.1.2.1 g):
Figure 4a:
• Gain = 1.0x: 22 secs
• Gain = 2.0x: 21 secs
• Gain = 0.5x: 10 sec with HR = 0
Figure 4b:
• Gain = 1.0x: 16 secs
• Gain = 2.0x: 18 secs
• Gain = 0.5x: 31 sec with HR = 0
Input Impedance
> 20 Mohms
Frequency Response
0.5 to 125Hz
Lead Off Detection Current
< 6 nA
Common Mode Rejection
Ratio
> 85 db
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Vital Sign Measurements
9.2.2 Respiration
Respiration
Method
Impedance Pneumography
Display Range
0 to 50 BR/MIN
Accuracy Range
3 to 50 BR/MIN
Accuracy
± 3 BR/MIN or 10% of reading, whichever is greater
Resolution
1 BR/MIN
Respiration Drive
Voltage:
1.00 V P-P ±5%
Frequency:
32.0 KHz ±2%
128
Vital Sign Measurements
9.2.3 Pulse Oximetry (SpO2, Functional Oxygen Saturation)
Pulse Oximetry (SpO2, Functional Oxygen Saturation)
Normative Reference
ISO 9919: 2005
SpO2
Display Range
49 to 100%
Accuracy Range
70 to 100%
Accuracy
≤ 2% from 70-100% (no motion)a
Unspecified from 49-69%
Resolution
1%
Display Range
0 to 240 BPM
Accuracy Range
30 to 240 BPM
Accuracy
(No Motion)
± 3 BPM; < 50 BPM @ ≥ 0.6% Pulsatile Modulation
± 3 BPM; ≥ 50 BPM @ ≥ 0.4% Pulsatile Modulation
Accuracy (RMS Error)
≤ 3 BPM
Rate Resolution
1 BPM
Pulse Rate
Validation Study
Per ISO 9919. The ViSi SpO2 is calibrated to display functional oxygen saturation
and validated against human subjects arterial blood sample reference measured with
CO-Oximeter (see table below).
Note: A functional tester cannot be used to assess the accuracy of a
pulse oximeter probe or a pulse oximeter monitor.
Calculation Rate
Every pulse
Display Refresh Rate
Every 3 seconds
Averaging
12 beat average following initialization
Alarm Range
Low - Fixed at 85%
Alarm Delay
30 seconds (fixed)
Waveform Display
•
•
Sensor Application Time
Sensor should be checked every 8 hours
Optical Wavelengths /
power
Red:
Infra-Red:
Interference
SpO2 can be adversely effected by the presence of dyshaemoglobins, ambient light
(including photosynamic therapy); electromagnetic interference; electro-surgical
units; dysfunctional hemoglobin; presence of certain dyes; inappropriate positioning
of the pulse oximeter probe.
Toxicity
Thumb sensor uses white silicone which has no known toxicity effects.
Amplitude is normalized
Sweep speed is scaled to 25mm/sec to match ECG
660nM / max 6.5mW (±15%)
905nM / max 5.2mW (±15%)
a. Bench testing indicates accuracy may be compromised at pulse rates below 50BPM at modulations less
than 0.6% and extremely low pulse rates of 30BPM at modulations less than 0.8%.
129
Vital Sign Measurements
The table below shows Arms values measured using the ViSi Mobile Thumb Sensor (Model 92-10020) with
the ViSi Mobile Monitoring System in a clinical study:
Validation Data (per ISO 9919)
Age of Volunteers
18 - 45
SpO2 Accuracy (No Motion)
Spo2 Range
Accuracy (Arms) - No Motion
70-100%
90-100%
80-90%
70-80%
1.9
1.2
1.9
2.4
Bland-Altman: ViSi Mobile Pulse Oximetry
130
Vital Sign Measurements
9.2.4 Non-Invasive Blood Pressure (NIBP)
Non-Invasive Blood Pressure (NIBP)
Normative Reference
ISO 81060-2: Non-invasive Sphygmomanometers - Part 2: Clinical validation of
automated measurement type.
Principle of Operation
Oscillometry
Systolic
Range:
60 to 240 mmHg
Accuracy:
Mean error of less than ± 5 mmHg and a std.dev. of ≤ 8 mmHg
Resolution:
1 mmHg
Range:
40 to 160 mmHg
Accuracy:
Mean error of less than ± 5 mmHg and a std.dev. of ≤ 8 mmHg
Resolution:
1 mmHg
Diastolic
Pulse Rate
Accuracy (NIBP) <3 BPM
Validation Study
Dual auscultatory observer
Reference: ISO 81060-2 First Edition 2009-05-01, Section 5.2.4.1, same arm
simultaneous method.
Number of subjects: 85
Subject age range: 18-79 years
Subject posture during data collection: Seated with feet on ground per ISO 81060-2
131
Vital Sign Measurements
Systolic Bland Altman Analysis
Sample Size:
255 data points
Mean:
12.7 mmHg
Standard Deviation:
6.6 mmHg
Linear Regression (Bland-Altman):
Y = -0.06974 x +6.0599
Upper 95% Limits of Agreement (+1.96 SD):
10.3 mmHg
Upper 95% Limits of Agreement (-1.96 SD):
-15.7 mmHg
Diastolic Bland Altman Analysis
Sample Size:
255 data points
Mean:
3.5 mmHg
Standard Deviation:
6.3 mmHg
Linear Regression (Bland-Altman):
Y = -0.05962 x +1.0917
Upper 95% Limits of Agreement (+1.96 SD):
15.9 mmHg
Upper 95% Limits of Agreement (-1.96 SD):
-8.9 mmHg
132
Vital Sign Measurements
9.2.5 Temperature
Temperature
Scale
Range / Accuracy
(measurement at
approximately 102 kPa
/ 768 mmHg)
Resolution
Transient Response
Range
Accuracy
Range
Accuracy
0o - 19.9o
±0.3o
32o - 67.9o
±0.5o
20o - 24.9o
±0.3o
68o - 76.9o
±0.5o
25o - 35.9o
±0.2o
77o - 96.7o
±0.3o
36o - 39.9o
±0.1o
96.8o - 103.9o
±0.2o
40o - 41.9o
±0.2o
104o - 107.5o
±0.3o
42o - 50.0o
±0.3o
107.6o - 122o
±0.5o
± 0.1o
< 6 min (25o - 37o)
± 0.1o
< 6 min (77o - 98.6o)
133
Physical Components
9.3 Physical Components
9.3.1 ViSi Mobile Monitor
ViSi Mobile Monitor
Physical Characteristics
Monitor
Dimensions
2.59 cm H x 4.85 cm W x 9.35 cm L
1.02 in. H x 1.91 in. W x 3.68 in. L
exclusive of connectors and Wrist Cradle
Weight
110 g / 3.92 oz
Display
OLED, 160 x 128 pixels, full color
Audio
Alarm annunciation, QRS, self-test
Waveforms
One waveform, user selectable
Aspect Ratio: 0.4 Sec/mV
Scaled equivalent to 25 mm/sec sweep speed
Respiration waveform scaled equivalent to 6.25
mm/sec sweep speed
Battery
Cleaning / Disinfecting
Operating Time
> 12 hours
Fuel Charge Display
Battery Symbol
Charge Level with Full Indication
Charge Time
Less than 4 hours
Battery Type
Li-Ion, 3.7 V., 2000 mAh, single cell
Liquid Ingress Rating
IPX7
During cleaning cycle only, not during monitoring
Solutions / Compounds
•
•
Isopropyl alcohol (IPA)
Green soap
Wireless Communications / Radio
Wireless Communications
Frequency
2.402 - 2.480 GHz
Protocol
802.11b
Modulation
Direct Sequencing Spread Spectrum
Security
WPA2 / PSK
Power Output (max)
8 mW (9 dBm)
WiFi Alliance Compliant
Yes; Reference Protocol: ASD 0478
Data Throughput
< 20 KBps
If you have any concerns regarding a Cybersecurity breach or vulnerability, contact
Sotera Wireless or an authorized Sotera Wireless representative in your area.
134
Physical Components
Mode Plugs
Mode Plugs
Shipping Plug
Turns device off completely
Bio Med Plug
Enables configuration and test functions
Locking Plug
Secures Monitor into Wrist Cradle
135
Physical Components
9.3.2 ViSi Mobile Chest Sensor Cable
ViSi Mobile Chest Sensor Cable
Mechanical
Complies with EC53
Length
54 cm (21.25 in)
Weight
(5 lead-wire / 3 lead-wire)
72 g / 62 g (2.54 oz. / 2.19 oz.)
Cleaning / Disinfecting
Liquid Ingress Rating
IPX7
During cleaning cycle only, not during monitoring
Solutions / Compounds
•
•
136
Isopropyl alcohol (IPA)
Green soap
Physical Components
9.3.3 ViSi Mobile Cuff Module
ViSi Mobile Cuff Module
Physical Characteristics
Battery
Cuff Sizes
Dimensions
3.10 cm H x 4.85 cm W x 12.19 cm L
(1.22 in. H x 1.91 in. W x 4.80 in. L)
exclusive of cable
Weight
157 g (5.54 oz)
Operating Time
> 30 cuff inflations or 24 hrs, whichever occurs
first
Charge Display Status
Eight LEDs: Six levels of Green, Yellow, Red
Charge Time
< 4 hours
Battery Type
Battery Pack, Li-Ion, 2000 mAh
Small
Medium
Large
Cleaning / Disinfecting
Liquid Ingress Rating
IPX0
During cleaning cycle only, not during monitoring
Solutions / Compounds
•
•
Isopropyl alcohol (IPA)
Green soap
When the ViSi Mobile Cuff Module is connected to the other ViSi Mobile
Components, the entire system has an ingress protection rating of IPX0.
137
Physical Components
9.3.4 ViSi Mobile Thumb Sensor
ViSi Mobile Thumb Sensor
Cleaning / Disinfecting
138
Liquid Ingress Rating
IPX7
During cleaning cycle only, not during monitoring
Solutions / Compounds
•
•
Isopropyl alcohol (IPA)
Green soap
Physical Components
9.3.5 ViSi Mobile Charger
ViSi Mobile Charger
Physical Characteristics
AC Mains
Cleaning / Disinfecting
Dimensions
7.64 cm. H x 12.7 cm. W x 6.35 cm. L
(3 in. H x 5 in. W x 2.5 in. L)
Weight
1.59 kg / 3.5 lbs
Power Supply
D.C. Input to Charger: 15VDC
AC Line Voltage
90-264 VAC, 47-63 Hz
Power (while charging)
50 w max
Liquid Ingress Rating
IPX0
During cleaning cycle only, not during monitoring
Solutions / Compounds
•
•
Isopropyl alcohol (IPA)
Green soap
139
Physical Components
9.3.6 ViSi Mobile Appliance
ViSi Mobile Appliance
Server Configuration
Single 1u, redundant hardware and internal RAID 10, dedicated hardware.\
Processor
Single Intel Xeon 5620
2.4 GHz (or equivalent CPU)
8 GB memory
Storage
Server contains (4) 500 GB 7200 RPM hard drives in RAID 6 array
Operating System
Note: SUSE Linux Enterprise Server (Version 11, Patch Level 2)
Network Requirements
Static IP address or DHCP reservation required
Multicast configuration on network backbone devices
Dimensions
(Single Appliance, may vary)
H: 43.0 cm x W: 43.4 cm x L: 62.7 cm (w/o ear, w/o bezel)
H: 1.7 in x W: 17.1 in x L: 24.7 in
Weight
35.02 lbs (15.9 kg)
(Single Appliance)
(Maximum configuration weight)
Power Requirements
100-240 VAC, 50-60 Hz, 7 A - 3.5 A w/ redundant power supply
(Single Appliance)
Backup Power Requirement
(Full System)
140
Customer supplied Uninterruptable Power Supply and Hospital Emergency
Power recommended.
Physical Components
9.3.7 ViSi Mobile Remote Viewer
ViSi Mobile Remote Viewer (Desktop PC with Touchscreen Display)
No. of Patients per Remote Viewer
Maximum 32
Display
23 in display / 1920 x 1080 resolution
(screen is touch sensitive to issue commands alternative to mouse/keyboard)
Processor
Intel i5 2400 CPU 4 Core
3.10 GHz
4 GB Memory
Storage
One 500 GB 7200 RPM SATA
Operating Systems
Microsoft® Windows® 7 Professional (version 6.1) x64 Bit SP1
Network Requirements
Ethernet Connection, DHCP
Dimensions
H: 45.0 cm x W: 58.5 cm x D: 10.3 cm
H: 17.7 in x W: 23.0 in x D: 4.1 in
Weight
26.7 lb (12.1 kg)
Power Requirements
AC/DC Adapter
Input: 100-240 V ~3.5 A, 50-60 Hz
Output to Viewer: 19.5 V / 11.8 A
Backup Power Requirement
Customer supplied Uninterruptable Power Supply and Hospital Emergency
Power recommended.
Note: Sotera Wireless recommends installation of Trend Micro anti-virus software on Windows
platforms. Anti-virus software is not installed on the ViSi Mobile Appliance.
141
Physical Components
9.3.8 Customer Network
Wireless Network
Wireless Network Standard
IEEE 802.11b
Recommended Channels
1, 6, 11
Network Latency
< 150 ms
Wireless Network Security Support
WPA2-PSK
Minimum Receiver Sensitivity
-65 dBm (edge coverage)
Wireless access point cell overlap
15-20%
Signal-to-Noise Ratio
≥25 dB
Packet loss
<8%
SSID
Dedicated or shared with other medical devices
Wired Network
Appliance (Server)
Requires static IP Address
Network availability
>99.9%
142
Alarms / Alerts Annunciation
9.4 Alarms / Alerts Annunciation
Note: When the ViSi Mobile Monitor is connected to a network (as indicated by the network
symbol in the top left hand corner of the display), the audio annunciation of non-lifethreatening alarms/alerts will be deferred to the Remote Viewer for a pre-configured period
of time. Within the tables below, see column “Deferral Delays” for the pre-defined periods of
time.
9.4.1 Physiological Alarms (Alarms)
Visual Display
The following table outlines the visual display when alarms are in progress:
Severity
Indicator Attributes
Toggle / Flash Speed
Duty Cycle
High Priority
Red
1.5Hz
50% ON
Life-Threatening Priority
Red / White
1.5Hz
50% ON
Audio Tones
The following table outlines the audio tones when alarms are in progress:
Severity
Melodya
Volume
[db]
Frequency
(fo) [Hz]
Duration
(td) [ms]
Spacing
(ts) [ms]
5th-6th
[s]
Inter-Burst
(tb) [s]
Life Threatening
b5.b5.b5..b5.b5
78
987.767
100
50
0.35
2.5
High
b5.b5.b5..b5.b5
78
987.767
200
100
0.35
a. Melodies are defined as musical notes.
Alarm Limits and Delays (factory default settings)
Lower Limit
Upper Limit
Annunciation Delay
Vital Sign
Unita
Deferral
Delay
Care Unit
Patient
Patient
Care Unit
Patient
Critical Low HR
18
18
N/A
N/A
N/A
N/A
N/A
Heart Rate
30
40
140
160
N/A
N/A
60
Pulse Rate
30
40
140
160
30
30
60
BP Systolic
70
90
190
240
N/A
N/A
60
BP Diastolic
40
50
120
150
N/A
N/A
60
Respiration
35
40
120
30
60
SpO2
N/A
N/A
85
85
30
30
60
Skin Temp
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Care
a. As the vital sign measurement approaches the care unit limit, the annunciation delay will decrease linearly.
143
Alarms / Alerts Annunciation
Delays
No Pulse Detected Alarms
Limit
Annunciation
Deferral
When Thumb Sensor is primary source
No Pulse
30
60
When Cuff Module is primary source
No Pulse
N/A
60
144
Alarms / Alerts Annunciation
Battery Alarms
Delays (in seconds)
Cuff
Module
Monitor
Battery Alarms
Limit
Annunciation
Deferral
Monitoring Mode
50oC (122oF)
N/A
N/A
In the Charger
40oC (104oF)
N/A
N/A
Not monitoring / Not in the Charger
40oC (104oF)
N/A
N/A
Connected to the Monitor
50oC (122oF)
N/A
N/A
In the Charger
40oC (104oF)
N/A
N/A
Not monitoring / Not in the Charger
40oC (104oF)
N/A
N/A
145
Alarms / Alerts Annunciation
9.4.2 Equipment Alarms (Alerts)
Visual Display
The following table outlines the visual display when alerts are in progress:
Severity
Indicator Attributes
Toggle / Flash Speed
Duty Cycle
All Severities
Cyan (Blue)
Constant (ON)
100% ON
Audio Tones
The following table outlines the audio tones when alerts are in progress:
Melodya
Volume
[db]
Frequency
(fo) [Hz]
Duration
(td) [ms]
Spacing
(ts) [ms]
Inter-Burst
(tb) [s]
High
e5.c5
68/63
659.255, 523.251
250
250
Medium
e5.c5
68/63
659.255, 523.251
250
250
15
Severity
a. Melodies are defined as musical notes.
Note: There are no audio tones associated with low severity alerts.
Alarm Limits and Delays (factory default settings)
Chest Sensor Alerts
Limit
(if applicable)
Delays (in seconds)
Annunciation
Deferral
ECG Lead Failure
N/A
N/A
120
All ECG Lead Failure
N/A
N/A
120
Chest Sensor Disconnected
N/A
N/A
120
General Fault Detected
N/A
N/A
120
Multiple Connections
N/A
N/A
N/A
Temperature Sensor Fault
N/A
N/A
120
Accelerometer Fault - Chest Module
N/A
N/A
120
Accelerometer Fault - Upper Arm
N/A
N/A
120
Thumb Sensor Alerts
Limit
(if applicable)
Delays (in seconds)
Annunciation
Deferral
SpO2 Signal Lost
N/A
< 30
120
Thumb Sensor Off
N/A
< 30
120
Thumb Sensor Disconnected
N/A
N/A
N/A
Thumb Sensor Failure
N/A
30
120
146
Alarms / Alerts Annunciation
Thumb Sensor Alerts
Limit
(if applicable)
SpO2 Unobtainable
N/A
Cuff Module Alerts
Limit
(if applicable)
Delays (in seconds)
Annunciation
Deferral
30
120
Delays (in seconds)
Annunciation
Deferral
4% to 10%
N/A
120
Battery Empty
< 4%
N/A
120
Cuff Leak
N/A
N/A
120
Cuff Occluded
N/A
N/A
120
NIBP Unobtainable
N/A
N/A
120
Invalid Software Loaded
N/A
N/A
120
Pressure Accuracy Fault
N/A
N/A
120
General Fault Detected
N/A
N/A
120
Pressure Exceeded
N/A
N/A
120
Multiple Connections
N/A
N/A
N/A
Wrist Monitor Alerts
Limit
(if applicable)
Low Battery
Delays (in seconds)
Annunciation
Deferral
Low Battery
120 minutes
N/A
N/A
Critical Low Battery
30 minutes
N/A
120
Too Low to Monitor
10 minutes
N/A
N/A
Invalid Plug Connected
N/A
N/A
N/A
Audio System Failure
N/A
N/A
120
Wireless Radio Failure
N/A
N/A
N/A
All Sensors Disconnected
N/A
N/A
N/A
Accelerometer Failure
N/A
N/A
120
Shock Hazard
N/A
N/A
120
5 Attempts
N/A
N/A
Patient Tampering
Motion Alerts
Limit
(if applicable)
Delays (in seconds)
Annunciation
Deferral
Heart Rate
Presence of motion
N/A
120
Pulse Rate
Presence of motion
N/A
120
Respiration
Presence of motion
N/A
120
SpO2
Presence of motion
N/A
120
147
Environmental Conditions
9.5 Environmental Conditions
Environmental Conditions for all ViSi Mobile Components
(Monitor, Cuff Module, Chest Sensor Cable, Charger, Cuff, Thumb Sensor)
Storage
(Packaged / Unpackaged)
Operating
(Unpackaged)
Temperature
-20oC to +55oC (50oC for NIBP)
-4oF to +131oF (122oF for NIBP)
0oC to +50oC
32oF to +122oF
Humidity
15% to 95% non-condensing
(90% for NIBP)
10% to 95% non-condensing
(90% for NIBP)
Atmospheric Pressure
Range
107 kPa to 50 kPa
803 mmHg to 375 mmHg
1.06 atm to 0.49 atm
107 kPa to 70 kPa
803 mmHg to 525 mmHg
1.06 atm to 0.69 atm
Condition
The ViSi Mobile Monitor may not perform to specification if stored or shipped
outside the specified temperature range.
9.6 Agency Compliances
Agency Compliances
•
•
•
•
•
•
•
•
•
•
•
•
•
148
ANSI/AAMI EC13, Cardiac monitors, heart rate meters, and alarms
ANSI/AAMI EC53, ECG cables and lead wires.
CAN/CSA C22.2 No 601.1 M90 Part 1: General requirements for basic safety and essential performance
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety
IEC 60601-1-2, Med. Elect. Equipment – Part 1-2: General requirements for safety – Collateral standard:
EMC – Req. and tests.
IEC 60601-1-4, Medical electrical equipment - Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems
IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements – Collateral standard:
Usability.
IEC 60601-1-8, Medical electrical equipment – Part 1-8: Gen. req. – Col. Std. Gen. requirements, tests and
guidance for alarm systems
IEC 60601-2-27, Medical electrical equipment, Part 2-27: Particular requirements or the safety, including
essential performance, of ECG monitoring equipment
IEC 80601-2-30, Medical electrical equipment – Part 2-30: particular requirements for the safety, including
essential performance, of auto. cycling non-invasive BP monitoring equipment.
ISO 9919, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
ISO 81060-2, Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement
type.
UL 60601-1 Part 1: General requirements for basic safety and essential performance
Safety and Performance Tests
9.7 Safety and Performance Tests
You must observe any national regulations on the qualification of the testing personnel and suitable
measuring and testing facilities. See User Maintenance on page 109 for a list of required tests.
9.7.1 Electromagnetic Compatibility (EMC) Specifications
Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical
equipment. You must operate your monitoring equipment according to the EMC information provided in
this manual. Portable and mobile radio frequency (RF) communications equipment can affect medical
electrical equipment.
Consult your Bio Med department or vendors for assistance in identifying
EMC compliance status of other medical devices when using the ViSi
Mobile Monitoring System.
Accessories Compliant with EMC Standards
All accessories (e.g. ViSi Mobile Charger) comply with either IEC 60601-1-2 or IEC 60950-1.
Using accessories other than those specified may result in increased
electromagnetic emission or decreased electromagnetic immunity of the
monitoring equipment.
149
Safety and Performance Tests
9.7.2 Electromagnetic Emissions
The ViSi Mobile Monitor is suitable for use in the electromagnetic environment specified in the table
below. You must ensure that the Monitor is used in such an environment.
Emissions Test
Compliance
Avoiding Electromagnetic Interference
Radio Frequency (RF) emissions
Group 1
The ViSi Mobile Monitor uses RF energy only for
its internal functiona. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions CISPR 11
Class A
Harmonic emissions IEC 61000-3-2
N/A
Voltage fluctuations IEC 61000-3-3
N/A
The ViSi Mobile Monitor is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage
supply network that supplies buildings used for
domestic purposes.
a. The battery operated ViSi Mobile Monitor contains a 2.4 GHz DSSS transmitter for the purpose of wireless communication. The radio is excluded for the EMC requirements of IEC 60601-1-2, but should be
considered when addressing possible interference issues between this and other devices.
150
Safety and Performance Tests
9.7.3 Electromagnetic Immunity
The ViSi Mobile Monitor is suitable for use in specified electromagnetic environment. The user must
ensure that it is used in the appropriate environment as described below.
IEC 60601-1-2
Immunity Test
Electromagnetic
Environment Guidance
Test Level
Compliance Level
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast
transient / burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
±1 kV for input/output lines
Mains power quality should
be that of a typical cial and/or
hospital environment.
Surge
IEC61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT) for 0.5
cycles
<5% UT
(>95% dip in UT) for 0.5
cycles
Mains power quality should
be that of a typical cial and/or
hospital environment.
40% UT
(60% dip in UT) for 5 cycles
40% UT
(60% dip in UT) for 5 cycles
70% UT
(30% dip in UT) for 25
cycles
70% UT
(30% dip in UT) for 25
cycles
<5% UT
(>95% dip in UT) for 5 sec
<5% UT
(>95% dip in UT) for 5 sec
3 A/m
3 A/m
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical cial and/
or hospital environment.
In the above table, UT (Unit in Test) is the ViSi Mobile Monitoring System.
151
Safety and Performance Tests
9.7.4 Recommended Separation Distance
The ViSi Mobile Monitor may be temporarily interrupted by UHF RFID
Systems (860-960MHz).
Portable and mobile RF communications equipment should be used no closer to any part of the ViSi
Mobile Monitor, including cables, than the recommended separation distance calculated from the equation
appropriate for the frequency of the transmitter.
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less
than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with this symbol:
In the following table, P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer and d is the recommended separation distance in meters (m).
Immunity Test
IEC 60601-1-2
Test Level
ViSi Mobile Monitoring
System Compliance Level
Electromagnetic Environment
Guidance
Conducted RF
IEC 61000-4-6
3 VRMS
150 kHz to 80 MHz
3 VRMS
Recommended separation distance:
d = 1.2√P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
Recommended separation distance:
80 MHz to 800 MHz
80 MHz to 800 MHz
d = 3.5√P
800 MHz to 2.5 GHz
d = 2.3√P
2.0 to 2.3 GHz for short radio
d = 7.0√P
Field strengths from fixed transmitters, such as base stations for radio (cellular, cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To access the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the ViSi Mobile Monitor is used exceeds the applicable RF compliance level above, the Monitor should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Monitor.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
152
Safety and Performance Tests
From Portable and Mobile RF Communication Equipment
The ViSi Mobile Monitor is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or user of the Monitor can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment and the Monitor as recommended below, according to the maximum output power of the
communications equipment.
In the following table, P is the maximum power output rating of the transmitter in watts (W) according to
the transmitter manufacturer and d is the recommended separation distance in meters (m).
Frequency
150 kHZ to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Equation
d = 1.2√P
d=1.2√P
d=2.3√P
Separation Distance
Separation Distance
Separation Distance
Rated max. output
power of transmitter
(m)
(ft)
(m)
(ft)
(m)
(ft)
0.01 W
0.1
0.4
0.1
0.4
0.2
0.8
0.1 W
0.4
1.2
0.4
1.2
0.7
2.4
1W
1.3
3.9
1.3
3.9
2.3
7.5
10 W
3.8
12.4
3.8
12.4
7.3
23.9
100 W
12.0
39.4
12.0
39.4
23.0
75.5
Electrosurgery Interference/Defibrillation/Electrostatic Discharge
The equipment returns to the previous operating mode within 10 seconds without loss of any stored data.
Measurement accuracy may be temporarily decreased while performing electrosurgery or defibrillation.
This does not affect patient or equipment safety. Do not expose the equipment to x-ray or strong magnetic
fields (MRI).
Fast Transients/Bursts
The equipment will return to the previous operating mode within 30 seconds without loss of any stored
data.
153
Wireless Network Risk Mitigation
9.8 Wireless Network Risk Mitigation
Reference: ISO 80001-1
ViSi Mobile System utilizes the Responsible Organization’s wireless IT network to communicate between
individual ViSi Mobile Monitors connected to patients and the ViSi Appliance. Physiologic data and
alarms originating from the ViSi Mobile Monitors are transmitted over the IT network to the ViSi Remote
Viewer where supplemental alarm notification occurs. Reliability of the IT network is essential in
ensuring the supplementary alarm notification meets the intended use.
Other RF radiating devices (such as high powered RFID readers and Bluetooth
devices) that are in close proximity with the ViSi Mobile Monitor may interfer with the
Monitor’s wireless communications. During such interference, the Monitor continues
to monitor and will alarm locally. If wireless communication is affected when using the
Monitor in close proximity with another RF radiating device, move the other device
away from the Monitor or discontinue use of the other device.
Perform a risk assessment and verification before you implement a change or
modification to the IT infrastructure. Changes to IT network configurations can
compromise continuous vital signs monitoring and alarm delivery.
9.8.1 Risk Analysis Summary
•
•
•
The ViSi Mobile Monitors are the source of all alarms and alerts.
The ViSi Remote Viewer provides a supplemental alarm notification. When connectivity is
present audio alarms are deferred to the ViSi Remote Viewer.
In the event that network connectivity is lost, all audio alarms are annunciated at the ViSi Mobile
Monitors. A connectivity lost alert is annunciated at the ViSi Remote Viewer.
9.8.2 Residual Risks
Loss of network connectivity will result in failure in supplemental alarm notification to the ViSi Appliance
and ViSi Remote Viewer. Management of this risk is the responsibility of the Responsible Organization
for the IT Network. This risk is minimized with the following mitigations:
Sotera Responsibilities
•
•
Sotera Inc network assessment prior to installation.
Sotera Inc verification that the Responsible Organization network meets ViSi Mobile System
connectivity requirements at the time of installation.
Responsible Organization Responsibilities
•
•
•
•
154
Conduct a risk assessment of the IT Network prior to installation and mitigate technical risk.
Maintain backup and emergency power resources for ViSi System network components specified
in the ViSi Installation Manual (Hardcopy: 95-10061 / CD: 95-10059).
Maintain network configuration post installation of the ViSi Mobile System.
Notify Sotera prior to modifications to the network, including any configurations changes that
could potentially compromise the IT Network as verified at the initial installation of the ViSi
System. For support contact Sotera Wireless or an authorized Sotera Wireless representative in
your area.
Appendix A - Symbols
Alarms / Alerts
Alarm / Alert States
Symbol
Description
Unacknowledged life threatening severity alarm in progress.
Unacknowledged high severity alarm in progress.
Unacknowledged alert in progress (any severity).
All alarms in progress have been acknowledged by the clinician.
Alarm annunciation (visual and audio) has been paused for 2 minutes.
Alarm annunciation (visual and audio) has been turned off.
Alarm Management
Symbol
Description
Pause alarm annunciation (visual and audible) for 2 minutes.
Turn off alarm annunciation (visual and audible).
Resume alarm annunciation from a paused state.
155
Alarms / Alerts
Symbol
Description
Turn alarm annunciation back on.
Acknowledge an alarm/alert that is in progress.
156
Battery States
Battery States
Symbol
Description
Battery good: the Monitor’s battery is fully charged.
Battery Low: the Monitor’s battery voltage is low.
Battery Critically Low: the Monitor’s battery voltage is critically low.
157
General Icons
General Icons
Navigation
Symbol
Description
Unlock the ViSi Mobile Monitor to gain access to the clinical features.
Lock the ViSi Mobile Monitor to prevent unwanted access to the clinical features.
Confirm activity.
Cancel activity.
Return to the previous screen.
Vital Signs Menu
Symbol
Description
Access to the clinical menu.
Start a manual cuff inflation. Cuff inflations are set up to be taken on an ad hoc basis.
Start a manual cuff inflation. Cuff inflations are set up to be taken automatically at a
selected time interval.
Stop a cuff inflation currently in progress.
Clinical Menu
Symbol
Description
Cuff management. Setup the cuff inflation intervals or define as ad-hoc only inflations.
Initiate the stop monitoring sequence.
158
General Icons
Symbol
Description
Access information regarding the ViSi Mobile Monitor: Monitor Id, MAC address, Serial #,
software version installed and battery status.
Alarm management. Review the patient’s current alarm limits, adjust the alarm limits using
“Auto Set” or turn off the alarm annunciation.
QRS beep is turned on.
QRS beep is turned off.
Other
Symbol
Description
Change a patient’s alarm limits using “Auto Set”.
Setup cuff inflation to be on an ad hoc basis.
Setup cuff inflation such that the cuff will inflate at defined intervals.
159
Labelling
Labelling
Symbol
Description
Warning, refer to accompanying documents
Caution, refer to accompanying documents
WiFi Alliance certification
Conforms with EEC directives
Catalog number
Serial Number
Manufactured By
Defibrillator proof type CF equipment
This product is designated for separate collection at an appropriate collection point. Do not
dispose of as household waste.
Lithium Ion battery
IPX0
No special protection.
IPX7
Protected against water immersion. Immersion for 30 minutes at a depth of 1 meter.
Latex free
Do not reuse
Fragile
CONT
160
Contents
Labelling
Symbol
Description
MRI Unsafe
161
Labelling
- Notes -
162
Appendix B - Model Numbers
Introduction
In the event any component needs to be replaced, contact the Sotera Wireless Inc. Customer Service
Department or the Sotera Wireless representative in your area.
If a component needs to be returned, prior to shipping ensure the returned components have been properly
disinfected.
163
ViSi Mobile System Components
ViSi Mobile System Components
Model Number
Description
92-10010
ViSi Mobile Monitor
92-10011
ViSi Mobile Cuff Module
92-10012
ViSi Mobile Chest Sensor (5 lead-wire ECG, AAMI)
92-10014
ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI)
92-10016
ViSi Mobile Chest Sensor (5 lead-wire ECG, IEC)
92-10018
ViSi Mobile Chest Sensor (3 lead-wire ECG, IEC)
92-10020
ViSi Mobile Thumb Sensor
92-10066
ViSi Mobile Patient Kit (Single-use, adult, S)
92-10067
ViSi Mobile Patient Kit (Single-use, adult, M)
92-10068
ViSi Mobile Patient Kit (Single-use, adult, L)
164
Accessories
Accessories
Model Number
Description
92-10023
ViSi Charger
165
Accessories
- Notes -
166
Appendix C - Warranty
Warranty
USA, Canada, Mexico, Puerto Rico
Sotera Wireless Inc. warrants that its products will be free from defects in workmanship and materials for a
period of one (1) year from the date of purchase except that disposable or one-time use products are
warranted to be free from defects in workmanship and materials up to a date one year from the date of
purchase or the date of first use, whichever is sooner. This warranty does not cover consumable items such
as, but not limited to, batteries, external cables, sensors, cuffs, hoses, or mounts.
Sotera Wireless Inc. shall not be liable for any incidental, special, or consequential loss,
damage, or expense directly or indirectly arising from the use of its products, liability under this warranty
and the buyer’s exclusive remedy under this warranty is limited to servicing or replacing at Sotera Wireless
Inc. option at the factory or at an authorized Sotera Wireless Inc. Distributor, any product which shall
under normal use and service appear to the Company to have been defective in material or workmanship.
No agent, employee, or representative of Sotera Wireless Inc. has any authority to bind
Sotera Wireless Inc. to any affirmation, representation, or warranty concerning its products, and any
affirmation, representation or warranty made by any agent, employee, or representative shall not be
enforceable by buyer.
This warranty is expressly in lieu of any other express or implied warranties, including any implied
warranty or merchantability or fitness, and of any other obligation on the part of the seller.
Damage to any product or parts through misuse, neglect, accident, or by affixing any nonstandard
accessory attachments or by any customer modification voids this warranty.
Sotera Wireless Inc. makes no warranty whatever in regard to trade accessories, such being subject to the
warranty of their respective manufacturers.
A condition of this warranty is that this equipment or any accessories which are claimed to be defective be
returned when authorized by Sotera Wireless, freight prepaid to Sotera Wireless Inc., San Diego,
California 92121. Sotera Wireless Inc. shall not have any responsibility in the event of loss or damage in
transit.
Calibration may be performed without the need to disassemble the instrument. It is the responsibility of the
purchaser to perform calibration as necessary, in accordance with the instructions provided in the technical
manual.
167
Sotera Wireless Responsibility
Sotera Wireless Responsibility
Sotera Wireless Inc. is responsible for the effects on safety, reliability and performance of the equipment
only if:
1. Assembly operations, extensions, readjustments, modifications or repairs are carried out by
persons authorized by Sotera Wireless Inc. and
2. The equipment is used in accordance with the instructions for use.
168
Index
Acknowledge
alarm doesn’t return after countdown 123
alarms
set limits to auto 104
Alarms and alerts
after sensor removed 122
message remains after resolved 122
multiple 123
charge battery 32
chest sensor cable 29
contraindications 20
Countdown period
alarm doesn’t return after 123
cuff module
description 28
device status screen 42
displays and views 40
battery charge screen 39
device status screen 42
menu screen 42
patient view screen 44
quiet monitoring screen 43
vital signs screen 41
Electrode Placement on page 19 29
general description 21, 35
Gray
alarm and alert messages 122
hardware
description 21, 35
hibernation screen 40
169
L
Life-Threatening alarms 122
menu screen 42
Messages
gray 122
some missing 123
monitor
cradle 25
MONITOR STOPPED alert 122
NIBP monitoring 39
Pacemaker patients, observing 12
PATIENT TAMPERING alert 123
patient view screen 44
precautions 17, 66
pulse oximetry (SpO2) monitoring 38
quiet monitoring screen 43
respiratory rate monitoring 37
Sensor removed, alarming continues 122
shipping plug
removing and inserting 22
thumb sensor
cable and connection 27
Tones, audio
remain at Monitor 122
stopped before acknowledged 122
ViSi Mobile Monitor
audio tone still occurs 122
vital signs screen 41
warnings 10, 75
170

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