Sotera Wireless VISI-MOBILE User Manual

Remote Viewer

0297

User manual

Reference Number (USB): 95-10134

Reference Number (Hardcopy): 95-10101

9444 Waples Street, Suite 280

San Diego, California 92121 USA

Phone: [phone] (U.S.)

[phone] (Intl)

Fax: [phone]

Email: [e-mail]

February 2014

Part Number: 6-000210-09.3

EMERGO EUROPE

Molenstraat 15, 2513BH

The Hague

The Netherlands

For additional information or assistance, please contact Sotera Wireless or an authorized Sotera Wireless
representative in your area.

1

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 any license to
these patents, trademarks, copyrights, or other intellectual property.

Information for servicing the ViSi Mobile Monitoring System 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.

© 2012 Sotera Wireless, Inc. All rights reserved.

ViSi Mobile

TM

and Sotera WirelessTM are trademarks of Sotera Wireless, Inc.

2

Content s

Chapter 1. Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Chapter 2. Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Chapter 3. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Areas on the ViSi Mobile Remote Viewer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Care Unit Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Work Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Patient Home View and Other Patient Views. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Patient Tiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Care Unit Patient Tiles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Patient Tiles in the Assigned Location Zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Patient Tiles in the Unassigned Location Zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Work Area Patient Tiles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Patient Tile in the Patient Home View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Patient Tiles in Other Patient Views. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Navigating to a Patient Home View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

To navigate to a Patient Home View from the Care Unit Area. . . . . . . . . . . . . . . . . . . . . . . . 33

To navigate to the Patient Home View from another patient view . . . . . . . . . . . . . . . . . . . . 34

System Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

To access the system help. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Shutdown the Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

To shutdown the application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Chapter 4. Wireless Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Wireless Monitoring with ViSi Mobile Remote Viewer . . . . . . . . . . . . . . . . . . . . 37

3

Communication with ViSi Mobile Remote Viewer . . . . . . . . . . . . . . . . . . . . . . . . 38

Monitoring a patient outside of network range . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Chapter 5. Setting Up Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Admit New Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

To admit a new patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Start Monitoring Before Admit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

To start monitoring before admit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Editing Patient Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

To edit patient information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Designating Patient Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Dragging and Dropping to a New Location. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

To drag and drop a Patient Tile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Entering Location Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

To enter location information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

ADT Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

To Select Patients from ADT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Chapter 6. Patient Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Viewing Vital Sign Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Vital Sign Measurements Displayed in the Care Unit Area . . . . . . . . . . . . . . . . . . . . . . . . . . 53

To view one patient’s measurements in a patient view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Viewing Graphical Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Viewing all Vital Sign Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

To view vital sign trends in graphical format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Viewing a Single Vital Sign Trend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

To view a single vital sign trend in graphical format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Graphical Trend Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Time scale Displays. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Trend Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Time Cursor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Patient Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Alarm/Events Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Viewing List Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

To view vital sign trends in tabular format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

List Trend Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Trend Displays. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Navigation/Scrolling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Viewing Current Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Viewing ECG Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

To view a patient’s current ECG waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Input Overload/Dynamic Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Patient Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

List Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

To Print the List Trends Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

4

Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

To Print the Waveform Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Chapter 7. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

System Alarm Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

General Alarm Management Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

In Network Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Physiological Alarms (Alarms) / Technical Alarms (Alerts) Summary . . . . . . . 71

Responding to Alarms/Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Managing Alarm/Alert Annunciations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Responding to Physiological Alarms (Alarms) . . . . . . . . . . . . . . . . . . . . . . . . . . 73

To Silence/Acknowledge Life Threatening Severity Alarms . . . . . . . . . . . . . . . . . . 73

To Silence High Severity Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Responding to Equipment Alarms (Alerts) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

To Silence/Acknowledge Alerts (All Severities) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Resume / Turn On Alarm Annunciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

To Resume Alarm Annunciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

To Turn On Alarm Annunciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

Manage Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

To change alarm limits individually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

To reset alarm limits to default values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

ViSi Mobile Remote Viewer Audio Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

To test the ViSi Mobile Remote Viewer Speaker. . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

Chapter 8. Pause / Stop Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Pause Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Stop Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Removing Patients from the Care Unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

To remove a patient from the Care Unit View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Chapter 9. Care Unit Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Care Unit Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

To view the ViSi Mobile Monitors currently in use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Chapter 10. Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Customer Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

ViSi Mobile Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Screen Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

ViSi Mobile Chest Sensor Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

ViSi Mobile Thumb Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

5

ViSi Mobile Cuff Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

ViSi Mobile Battery Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

General Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

Connectivity Lost. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

Alarms and Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

ViSi Mobile Remote Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Setting Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Chapter 11. Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Vital Sign Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Heart Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Respiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Pulse Oximetry (SpO2, Functional Oxygen Saturation). . . . . . . . . . . . . . . . . . . . . 110

Non-Invasive Blood Pressure (NIBP). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Continuous Non-Invasive Blood Pressure (cNIBP) . . . . . . . . . . . . . . . . . . . . . . . . 114

Skin Temperature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

Physical Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

ViSi Mobile Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Wireless Communications / Radio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Mode Plugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

ViSi Mobile Chest Sensor Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

ViSi Mobile Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

ViSi Mobile Thumb Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

ViSi Mobile Charger - 8 Bay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

ViSi Mobile Charger - 2 Bay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

ViSi Mobile Appliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

ViSi Mobile Remote Viewer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Customer Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

Alarms / Alerts Annunciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Physiological Alarms (Alarms). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Visual Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Audio Tones. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Equipment Alarms (Alerts) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Visual Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Audio Tones. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Environmental Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

Compliances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Federal Communications Commission (FCC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Electromagnetic Compatibility (EMC) Specifications. . . . . . . . . . . . . . . . . . . . . . . 134

Accessories Compliant with EMC Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Recommended Separation Distance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

From Portable and Mobile RF Communication Equipment . . . . . . . . . . . . . . . . . . . . . . . . . 138

Electrosurgery Interference/Defibrillation/Electrostatic Discharge . . . . . . . . . . . . . . . . . . . . 138

6

Fast Transients/Bursts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Wireless Network Risk Mitigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Risk Analysis Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Residual Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Sotera Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Responsible Organization Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Appendix A. Alarm Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Patient Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Life Threatening Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

High Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

Equipment Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

ViSi Mobile Monitor Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

ViSi Mobile Chest Sensor Cable and ECG Alerts . . . . . . . . . . . . . . . . . . . . . . . . . 146

ViSi Mobile Thumb Sensor and SpO2 Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

ViSi Mobile Cuff Module and NIBP Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Miscellaneous Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

ViSi Mobile Charging Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

ViSi Mobile Monitor Status Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

Battery Charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

Wireless Radio Signal Strength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

Appendix B. Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

Alarms / Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

Alarm / Alert States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

Alarm Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Battery States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

General Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

Out of Range Vital Signs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

Navigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

Vital Signs Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

Clinical Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Patient’s Postures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Unknown Posture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Postures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158

Appendix C. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Third Party Branded Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Warranty Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

7

Sotera Wireless Responsibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Contact Sotera Wireless . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

8

1. Preface

1.1 Introduction

The suite of ViSi Mobile Monitoring System™ user manuals are intended to provide information for the
proper operation of the Sotera Wireless ViSi Mobile Monitoring System™. The suite of manuals
comprises of:

• ViSi Mobile Monitoring System User Manual

• ViSi Mobile Remote Viewer User Manual

• ViSi Mobile myRemote Viewer User Manual

A formal knowledge of patient monitoring and an understanding of the features and functions of the
system are prerequisites for its proper use.

These manuals are written for trained clinicians. Although the manuals 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.

1

Do not operate the ViSi Mobile Monitoring System before reading these
instructions.

1. The ViSi Mobile myRemote Viewer User Manual is a system that comprises the functionalies of the ViSi
Mobile Appliance and the ViSi Mobile Remote Viewer. The ViSi Mobile myRemote Viewer User Man­ual only contains instructions specific to the myRemote Viewer functionality. Refer to the ViSi Mobile
Remote Viewer Manual for wireless technology and system specifications, operating characteristing,
quality of service, wireless security measures, information regarding wireless coexistence issues and mit­igations, EMC standards compliance and warnings about possible effects from RF sources in the vicinity
of the device.

9

Intended Use

1.2 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 (18 years or older). It is indicated for
ECG (3 or 5 lead-wirelead-wire), respiration rate, heart rate, non-invasive blood pressure (NIBP),
continuous non-invasive blood press (cNIBP), non-invasive monitoring of functional oxygen saturation of
arterial hemoglobin (SpO
medical-surgical floors, intermediate care floors, and emergency departments.

Continuous non-invasive blood pressure (cNIBP) testing has not be conducted on ambulatory patients.

The ViSi Mobile Monitoring System may be used as standalone devices or networked to a ViSi Mobile
Remote Viewer through wireless 802.11 communication.

1.2.1 Contraindications

• 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 18 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.

• The effectiveness of the ViSi Mobile Monitoring System’s blood pressure monitoring has not been

established in the presence of any dysrhythmias.

), pulse rate, and skin temperature in hospital-based facilities; including general

2

10

2. Warnings and Cautions

2.1 Introduction

Please read and adhere to all warnings, cautions and notes listed here and in the associated sections
throughout this manual.

Do not operate the ViSi Mobile Monitoring System before reading these instructions.

Warning statement s 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.

11

Warnings

2.2 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 18 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.
Avoid electrosurgery burns at the ECG monitoring sites by ensuring the electrosurgery-

return circuit is connected properly.
Monitoring may be temporarily interrupted during the use of electrosurgery in the vicinity

of/or on a patient being monitored with a ViSi Mobile Monitoring System. Observe the
patient closely while electrosurgery 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.

12

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.

Warnings

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.
When the “Monitor Too Hot” alarm is in progress, ViSi Mobile Monitoring System should

be removed from the patient immediately. Leaving on the patient for an extended
period of time may lead to a skin burn.

When the “Cuff Battery Temp” alarm is in progress, ViSi Mobile Cuff Module should be
removed from the patient immediately. Leaving on the patient for an extended period of
time may lead to a skin burn.

Disposable Components

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. Dispose of the components after use per your
facility’s policy.

13

Warnings

Warnings

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.
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. Using non-approved Thumb Sensors may result in
inaccurate SpO

readings or damaged equipment.

2

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 per your facility’s protocol. If skin surface has been
compromised, reposition the ViSi Mobile Thumb Sensor or move the Thumb Sensor to
the patient’s other thumb.

Ensure the ViSi Mobile Thumb Sensor is securely fastened. A Thumb Sensor that is
wrapped too tight or too loose can adversely affect SpO

measurement.

2

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.

Before monitoring a new patient, ensure all the sensors have been removed and that
monitoring was stopped using the Stop Monitoring procedure.

14

To prevent settings from being inadvertently changed, lock the ViSi Mobile Monitor
screen (if enabled) as soon as tasks are completed.

Warnings

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 interfere 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.

After monitoring has been stopped on the ViSi Mobile Monitor, removing the patient
from the ViSi Mobile Remote Viewer cannot be undone. Once removed, the patient will
no longer be available on the Remote Viewer.

Warnings

All wireless devices are susceptible to radio frequency interference that can disrupt
connectivity. If excessive ViSi Mobile Monitoring System disconnections are observed,
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 biomedical engineer 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 implementing a change or
modification to the IT infrastructure. Changes to IT network configurations can
compromise continuous vital signs monitoring and alarm delivery.

15

Warnings

Warnings

Vital Signs

If a vital signs measurement is questionable, retake the measurement. If the result is
still questionable, use a different method of measurement.

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.

Chest Sensor Cable: ECG, Respiration, Temperature (Skin)

Use all of the same type of high quality ECG electrodes on the patient. Mixing ECG
electrode types can adversely affect ECG monitoring.

Avoid placing the ViSi Mobile Cable Securements and ECG electrodes over areas of
abrasions, irritation, or other sensitive areas. If possible, remove, reposition, and
replace ECG electrodes and Cable Securements if the patient complains of pain/itching
at the sites.

The ViSi Mobile Monitor does not provide automated arrhythmia analysis. As a result,
certain arrhythmias may cause the Monitor to display variable heart rates. If frequent
arrhythmias are suspected, their presence should be confirmed by visual observation of
the ECG waveform or another method, such as a 12-lead ECG.

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 visual observation of the ECG waveform or 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 SpO

, should be assessed as well.

2

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.

16

Warnings

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.

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. Recommend using the ViSi Mobile
Monitoring System on the opposite arm.

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.

SpO

2

Oxygen saturation measurements using SpO

are dependent on proper sensor

2

placement, exposure to ambient light conditions, and general patient conditions. Before
making clinical decisions based on SpO

measurements, verify the measurement using

2

another clinically acceptable method, such as arterial blood gas analysis.
High ambient light condition, including direct sunlight, may interfere with the

performance of the ViSi Mobile Thumb Sensor.
Low perfusion, electrosurgical devices, dysfunctional haemoglobin, the presence of

certain dyes and inappropriate positioning of the ViSi Mobile Thumb Sensor may result
in erroneous measurements.

17

Warnings

Warnings

Alarms / Alerts

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 Auto Set is selected (on the ViSi Mobile Monitor), review the newly calculated
alarm limits carefully before deciding to confirm or cancel the new alarm limits. Once
new alarm limits are confirmed on the ViSi Mobile Monitor, they cannot be changed
back to the original pre-set limits from the ViSi Mobile Monitor. Use the ViSi Mobile
Remote Viewing Device to change the alarm limits back to the original pre-set limits.

When the ViSi Mobile Monitor is not connected 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.

When the last source of monitoring is lost due to equipment (such as thumb sensor off,
ECG leads off, all sensors disconnected) the visual annunciation of the alert will not
have an audible component.

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.

When testing the speaker at the ViSi Mobile Remote Viewer, if the tone does not sound
or it is not loud enough check the speaker volume is turned up. If the sound is still not
sound loud enough, immediately contact a biomedical engineer. The test indicates how
alarm and alert tones sound at the Remote Viewer. If the volume is inadequate,
clinicians could miss alarms and alerts.

User Maintenance

To avoid contaminating or infecting personnel, the environment or other equipment,
make sure to 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.

18

Warnings

Wireless Communications

When the ViSi Mobile Monitor is not configured to connect to the facility’s network 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 cyber security 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.

Warnings

19

Cautions

2.3 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.

The effectiveness of the ViSi Mobile Monitoring System’s blood pressure monitoring
has not been established in pregnant, including pre-eclamptic, patients.

General

When the application is shutdown, remote monitoring will not be available.
Placing the ViSi Mobile Monitor into the Charger when the “All Sensors Disconnected”

alert is displayed will result in the patient’s monitoring session being stopped. It is
recommended that you follow the correct stop/pause monitoring flows.

When monitoring has been paused, monitoring may only be resumed using the same
ViSi Mobile Monitor. If you place the ViSi Mobile Monitor into the Charger with other
Monitors, label the Monitor so that is can be identified when monitoring is to be
resumed.

Moving the ViSi Mobile Monitor out of the network range will break the radio link,
immediately stopping communication of patient vital signs data to the ViSi Mobile
Remote Viewer.

When the wireless connector symbol is yellow, the ViSi Mobile Monitor is unable to
connect to the ViSi Mobile Remote Viewer (via the ViSi Mobile Appliance).

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 intended for home use.
Do not use the ViSi Mobile Monitoring System to monitor a patient in a wet

environment, such as a shower.

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Cautions

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.

Changes in posture can affect ViSi cNIBP accuracy. Recalibrate ViSi cNIBP whenever
torso changes by more than 30

o

above supine position.

Cautions

The accuracy of the cNIBP measurement cannot be relied upon in patients with a BMI
greater than 35.

Due to cNIBP signal averaging, there is a time delay between the instantaneous blood
pressure reading and the displayed reading.

You should manually recalibrate cNIBP after any drug administration. The Calibrate
cNIBP alert will not be annunciated.

If using the ViSi Mobile Monitor with any other monitor on the same patient, check that
each monitor does not interfere with the operation of the other. If interference is
detected, remove one or more of the sensors until there is no longer any interference.

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.

General maintenance of the ViSi Mobile Monitoring System should be conducted at the
hospital defined intervals.

The ViSi Mobile Monitoring System components should only be serviced by Sotera
Wireless, Inc. technicians or authorized service providers.

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Cautions

Cautions

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.

Avoid touching the ViSi Mobile Disposable Cuff during cuff inflation as it may disrupt the
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 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 or the 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.

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Thumb sensors which are saturated with liquid 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.

Cautions

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 Disposable 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.

Cautions

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Notes

2.4 Notes

Note: Figures in this manual are provided for r efer ence 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.

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3. Overview

ViSi Mobile Monitoring System

The ViSi Mobile Monitoring System enables clinicians to remotely monitor patients who are connected to

ViSi Mobile Monitors. A system includes ViSi Mobile Monitors (see 95-10134), a ViSi Mobile Appliance

and a ViSi Mobile Remote Viewer. Information flows wirelessly and bidirectionally between components.

After connecting a patient to a ViSi Mobile Monitor, the patient’s information appears on the ViSi Mobile
Remote Viewer. Once monitoring has been started, the following tasks may be accomplished remotely:

• View vital sign measurements, for the care unit and for individual patients

• Assign room and identification to patients

• Adjust vital sign alarm limits

• View ECG and other waveforms for individual patients

• Receive and acknowledge alarm and alert notifications

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Areas on the ViSi Mobile Remote Viewer

Patient TilesPatient Tiles

Assigned Location Zone

Unassigned Location Zone

Care Unit Area

3.1 Areas on the ViSi Mobile Remote Viewer

The ViSi Mobile Remote Viewer includes a Care Unit area and a Work Area.

3.1.1 Care Unit Area

The Care Unit Area always appears, displaying Patient Tiles for all actively monitored patients in the unit:

• The Assigned Location Zone shows patients with assigned rooms/beds.

• The Unassigned Location Zone shows patients without assigned rooms/beds.

Depending on your system configuration, the number and appearance of Patient Tiles on your ViSi Mobile
Remote Viewer can vary.

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Areas on the ViSi Mobile Remote Viewer

Work Area

3.1.2 Work Area

Views that open in the Work Area display further information about one patient.

Touching a Patient Tile selects the patient and their Patient Home View opens in the Work Area (shown on
page 28). From the Patient Home View, touch or click tabs to navigate to other views for the selected

patient.

In patient views, the following tasks may be performed:

• Edit patient information

• View and adjust alarm limits

• View more in-depth vital sign measurements, such as current waveforms

• Remove a patient from the care unit

To open patient views for a different patient, touch or click the patient’s Patient Tile. To close all patient
views and return to a blank Work Area, touch or click the currently selected Patient Tile.

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Areas on the ViSi Mobile Remote Viewer

Selected patient’s Patient Home View

Selected Patient Tile

(Work Area)

Menu

Patient Tabs

Patient Home View and Other Patient Views

When a Patient Tile in the Assigned Location Zone or Unassigned Location Zone is touched or clicked, the
patient is selected and their Patient Home View opens in the Work Area.

When a patient has been selected, a set of Patient Tabs will be displayed at the top of the Work Area.
These tabs enable navigation around the different patient views.

When the Patient Home menu is displayed. These menu items enables the following tasks:

• Adjust the patient’s alarm limits

• Edit the patient’s information

• Remove a patient from the care unit

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Patient Tiles

Patient’s Vital Sign

Patient Posture/Status (ViSi Man™) /

ViSi Mobile Monitor Status

- Monitor Number

Measurements

Equipment Status

OR

- Network Connection Strength

- Battery Status

3.2 Patient Tiles

Patient Tiles appear in the Care Unit Area and in the Work Area.

3.2.1 Care Unit Patient Tiles

Patient Tiles in the Assigned Location Zone

Patient Tiles in the Assigned Location Zone vary in size, depending on your care unit configuration.

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Patient Tiles

Patient’s Vital Sign

Patient Posture/Status (ViSi Man™) /

Measurements

Equipment Status

ViSi Mobile Monitor Status

- Monitor Number

- Network Connection Strength

- Battery Status

Patient Tiles in the Unassigned Location Zone

The Unassigned Location Zone of the Care Unit Area holds Patient Tiles for patients that have not been
assigned a room/bed.

Note: When a patient has been selected from either the Assigned Patients or the Unassigned

Patients Zones, the Unassigned Patients Zone will be condensed to provide enough room to
display the selected patient’s details.

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