Sotera Wireless VISI MOBILE 1 User Manual

Monitoring System

0297

User manual

Reference Number (USB): 95-10134

Reference Number (Hardcopy): 95-10060

10020 Huennekens Street

San Diego, California 92121 USA

Phone: [phone] (U.S.)

[phone] (Intl)

Fax: [phone]

Email: [e-mail]

July2015

Part Number: 6-000212-15

EMERGO EUROPE

Molenstraat 15, 2513BH

The Hague

The Netherlands

For additional information or assistance, please contact Sotera® Wireless, Inc. or an authorized Sotera
Wireless, Inc. 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 you any
license to these patents, trademarks, copyrights, or other intellectual property.

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

© 2015 Sotera Wireless, Inc. All rights reserved.

ViSi Mobile

®

Monitoring System is a trademark of Sotera® Wireless, Inc.

2

Contents

Chapter 1. Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

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

Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Chapter 2. ViSi Mobile Warnings and Cautions. . . . . . . . . . . . . . . . . . 13

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Disposable Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Patient Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Vital Signs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Chest Sensor CableChest Sensor: ECG, Respiration, Temperature (Skin). . . . . . . . . . 19

Cuff Module / NIBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Alarms / Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

User Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Wireless Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Off-The-Shelf (OTS) Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Service / Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Equipment / Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Cleaning / Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Chapter 3. General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Unpacking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Removing and Inserting the Shipping Plug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

To remove the Shipping Plug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

To insert the Shipping Plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

1

ViSi Mobile Disposable Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

ViSi Mobile Disposable Cuff. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

ECG Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

ViSi Mobile Wrist Cradle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

ViSi Mobile Thumb Wrap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

ViSi Mobile CableChest Sensor Securements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

ViSi Mobile Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

ViSi Mobile Thumb Sensor (SpO2/PR). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

ViSi Mobile Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

ViSi Mobile Chest Sensor CableChest Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

ViSi Mobile Charger. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

To set up the Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Charging the ViSi Mobile Monitor and Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . 40

The ViSi Mobile Charger provided by Sotera Wireless, Inc. is the required Charger
for both the Monitor and the Cuff Module as well as for the optional ViSi Power Pack.
The Charger is capable of charging up to eight of any combination of Mon itors, Cuff
Modules and Power Packs. To charge either the Monitor or the Cuff Module place

the flat end into one of the slots with the front facing outwards. . . . . . . . . . . . . . . 40

To chargeCharging the a Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

To chargeCharging the a Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Charging the Optional ViSi Power Pack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Chapter 4. Clinical Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Key Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Overview of Clinical Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

ECG Monitoring and Heart Rate (HR) Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Respiration Rate (RESP) Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Skin Temperature (TEMP) Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Pulse Oximetry (SpO2 and Pulse Rate) Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . 48

NIBP Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Display Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Battery Charge Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Hibernation Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Vital Signs Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Menu Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Monitor Status Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Quiet Monitoring Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Patient View Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Chapter 5. Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Preparing for a New Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Inspecting the Equipment and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Applying Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Selecting Vital Signs to Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Selecting the ViSi Mobile Chest Sensor CableChest Sensor . . . . . . . . . . . . . . . . . 59

2

Selecting the ViSi Mobile Disposable Kit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Checking the Battery Charge of the ViSi Mobile Monitor

and Cuff Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

To check the battery charge of the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

To check the battery charge of the Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Applying ViSi Mobile Monitoring System / Initiate Monitoring . . . . . . . . . . . . . 63

Applying the ViSi Mobile Wrist Cradle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

To apply the Wrist Cradle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Applying Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Applying the ViSi Mobile Thumb Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

To apply the Thumb Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Applying the ViSi Mobile Chest Sensor CableChest Sensor and ECG Electrodes 69

Skin Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

3 lead-wire and ECG Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

5 lead-wire and ECG Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

To apply the Chest Sensor CableChest Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Applying the ViSi Mobile Cuff Module and Disposable Cuff . . . . . . . . . . . . . . . . . . 75

To apply the Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Removing ViSi Mobile Monitoring System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

To remove Cuff and Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

To remove the Chest Sensor CableChest Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

To remove the Thumb Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

To remove the Wrist Cradle and Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Clinical Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

.XML File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Units of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Monitor Timeout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Clinical Authentication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Skin Temperature Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

Chapter 6. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

System Alarm Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

General Alarm Management Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

In Network Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Physiological Alarms (Alarms) / Technical Alarms (Alerts) Summary . . . . . . . 83

Responding to Alarms/Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Managing Alarm/Alert Annunciations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

Responding to Physiological Alarms (Alarms) . . . . . . . . . . . . . . . . . . . . . . . . . . 85

To Silence/Acknowledge Life Threatening Severity Alarms . . . . . . . . . . . . . . . . . . 85

To Silence High Severity Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Responding to Equipment Alarms (Alerts) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

To Silence/Acknowledge Alerts (All Severities) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

Managing Alarm Annunciations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Pause / Resume Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

To pause the alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

To Resume Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Turn Alarm Annunciation On / Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

To turn all alarms off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

3

To Turn On Alarm Annunciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Manage Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

To change alarm limits using Auto Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Testing Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Battery Too Hot Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

Monitor Too Hot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

Cuff Module Battery Temp (Cuff Too Hot). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Chapter 7. User/Preventative Maintenance . . . . . . . . . . . . . . . . . . . . 105

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

Preventative Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Prior to cleaning and disinfecting: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Recommended cleaning/disinfection agents. Use either of the following: . . . . . . . . . . . . . . 107

To clean the ViSi Mobile Monitoring System components. . . . . . . . . . . . . . . . . . . . . . . . . . 108

To disinfect the ViSi Mobile Monitoring System components . . . . . . . . . . . . . . . . . . . . . . . 108

Inspecting Equipment and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

ViSi Mobile Chest Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

ViSi Mobile SpO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

ViSi Mobile Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

ViSi Mobile Charger. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

ViSi Mobile Remote Viewer/Appliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

ViSi Mobile Monitoring System Battery Replacement. . . . . . . . . . . . . . . . . . . . . . 110

ViSi Mobile Optional Power Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

Product Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Chapter 8. Patient Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Securing the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

Locking the Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

To lock the Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

Unlocking the Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

To unlock the Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

Patient Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

Viewing Vital Signs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

To view vital signs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

Viewing Waveforms Associated with Vital Signs . . . . . . . . . . . . . . . . . . . . . . . . . . 117

To view the ECG waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

To view other leads with the Chest Sensor CableChest Sensor . . . . . . . . . . . . . . . . . . . . . 118

To view the RESP waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

To view the SpO2 waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Motion Artifact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

Setting Up/Taking NIBP Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Selecting Blood Pressure Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

To select the blood pressure mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Taking a NIBP Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

To take a single NIBP measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

To stop an NIBP measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

Initiating Automatic NIBP Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

4

To initiate automatic NIBP measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Calibrating Continuous NIBP Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

To calibrate NIBP for continuous monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

To stop the cNIBP calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

To recalibrate cNIBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

Patient’s Posture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

To View the Patient’s Posture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

To Select/Confirm the Patient’s Posture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

Viewing Patient’s Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

To Confirm Patient’s Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

To View Patient’s Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Exchanging a Monitor With Low Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

To exchange a monitor with a low battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Pause Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

To pause monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Stop Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

To stop monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

To clean and prepare reusable components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

All Sensors Disconnected. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Disable Skin Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Chapter 9. Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Customer SupportService. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

ViSi Mobile Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Screen Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

ViSi Mobile Chest Sensor CableChest Sensor . . . . . . . . . . . . . . . . . . . . . . . . . 149

ViSi Mobile Thumb Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

ViSi Mobile Cuff Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

ViSi Mobile Battery Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

ViSi Power Pack (Optional Accessory) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

General Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Connectivity Lost. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Alarms and Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

ViSi Mobile Remote Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

Setting Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

Chapter 10. Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Vital Sign Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Heart Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Respiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

Pulse Oximetry (SpO2, Functional Oxygen Saturation). . . . . . . . . . . . . . . . . . . . . 166

Non-Invasive Blood Pressure (NIBP). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

Continuous Non-Invasive Blood Pressure (cNIBP) . . . . . . . . . . . . . . . . . . . . . . . . 170

Skin Temperature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

Physical Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

5

ViSi Mobile Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

Wireless Communications / Radio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

Mode Plugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

ViSi Mobile Chest Sensor CableChest Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

ViSi Mobile Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

ViSi Mobile Thumb Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

ViSi Mobile Charger - 8 Bay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

ViSi Mobile Charger - 2 Bay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

ViSi Mobile Power Pack (Optional Accessory) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180

ViSi Power Pack Cradle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180

ViSi Mobile Appliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

ViSi Mobile Remote Viewer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182

Customer Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

Alarms / Alerts Annunciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

Physiological Alarms (Alarms). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

Visual Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

Audio Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

Equipment Alarms (Alerts) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

Visual Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

Audio Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

Environmental Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

Compliances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190

Federal Communications Commission (FCC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190

Electromagnetic Compatibility (EMC) Specifications. . . . . . . . . . . . . . . . . . . . . . . 191

Accessories Compliant with EMC Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

Recommended Separation Distance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194

From Portable and Mobile RF Communication Equipment . . . . . . . . . . . . . . . . . . . . . . . . . 195

Electrosurgery Interference/Defibrillation/Electrostatic Discharge . . . . . . . . . . . . . . . . . . . . 195

Fast Transients/Bursts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195

Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196

Wireless Network Risk Mitigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

Risk Analysis Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

Residual Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

Sotera Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

Responsible Organization Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

Appendix A. Alarm Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

Patient Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

Life Threatening Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

High Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200

Equipment Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

ViSi Mobile Monitor Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

ViSi Mobile Chest Sensor CableChest Sensor and ECG Alerts . . . . . . . . . . . . . 202

ViSi Mobile Thumb Sensor and SpO2 Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

ViSi Mobile Cuff Module and NIBP Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

ViSi Power Pack Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204

Miscellaneous Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

6

ViSi Mobile Charging Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

ViSi Mobile Monitor Status Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

Battery Charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

Wireless Radio Signal Strength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .206

Appendix B. ViSi Power Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

Warnings And Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208

General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209

ViSi Power Pack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209

ViSi Power Pack Cradle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210

Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211

Inspecting the Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211

Checking the Battery Charge of the ViSi Power Pack . . . . . . . . . . . . . . . . . . . . . . 211

To check the battery charge of the ViSi Power Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212

Charging the ViSi Power Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212

Using the ViSi Power Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

Replacing the ViSi Power Pack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

To replace a depleted ViSi Power Pack while still monitoring a patient: . . . . . . . . . . . . . . . 217

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218

Equipment Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219

User/Preventative Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219

Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219

Appendix C. Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

Alarms / Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

Alarm / Alert States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

Alarm Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

Battery States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223

ViSi Mobile Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223

General Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

Out of Range Vital Signs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

Navigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

Vital Signs Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

Clinical Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

Patient’s Postures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228

Unknown Posture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228

Postures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228

Labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229

Appendix D. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233

Third Party Branded Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233

7

Warranty Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233

Sotera Wireless, Inc. Responsibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234

Contact Sotera Wireless . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234

8

- Notes -

9

10

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, Inc. ViSi Mobile Monitoring System. The suite of manuals
consists of:

• ViSi Mobile Monitoring System User Manual

• ViSi Mobile Remote Viewer User Manual

• ViSi Mobile Technical Reference 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.

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

11

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-wire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP),
continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation
of arterial hemoglobin (SpO
including general medical-surgical floors, intermediate care floors, and emergency departments.

The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile
Remote Viewers 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 evaluated 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 accuracy of the ViSi Mobile Monitoring System’s NIBP and cNIBP monitoring has not been
established in the presence of any dysrhythmias.

• Continuous non-invasive blood pressure (cNIBP) measurements have not been evaluated on
patients during ambulation.

), pulse rate (PR), skin temperature (TEMP) in hospital-based facilities;

2

12

2. ViSi Mobile 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 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:

Statements provide supplemental information to the user.

13

Warnings

2.2 Warnings

Intended Use

Do not use the ViSi Mobile Monitoring System or Power Pack 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 evaluated for these patient
groups.Do not use the ViSi Mobile Monitor as a primary hypoxia diagnostic tool.

Safety

The ViSi Power Pack is not intended to be worn by the patient.

Do not modify the ViSi System in any way.

Do not use the ViSi Mobile Monitor, Cuff Module, Chest Sensor or Power Pack in an
MRI suite or a hyperbaric chamber.

The ViSi System is protected against damage from electrosurgery. Avoid electrosurgery
burns at the ECG monitoring sites by ensuring the electrosurgery-return circuit is
connected properly and monitoring electrodes are located as far as possible from the
electrosurgery site.

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.

Do not connect more than one ViSi Power Pack to the ViSi Mobile Monitor
simultaneously.

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.

14

Route all ViSi Mobile Monitoring System cabling to avoid the possibility of patient
entanglement or strangulation.

Warnings

Warnings

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 directly to an 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.

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 Power Pack directly to an AC power outlet. To recharge the
battery, disconnect the Power Pack from the patient, and then place it in the ViSi Mobile
Charger.

Do not touch the electrical contacts on the ViSi Power Pack or use the ViSi Power Pack
without it first being inserted into the ViSi Power Pack Cradle. Doing so may result in
electric shock from the battery.

When not in use, disconnect the ViSi Power Pack from the Monitor.

Do not modify the ViSi Power Pack in any way.

If the ViSi Power Pack beeper/buzzer sounds or the Red LED is permanently lit, the
ViSi Power Pack should be disconnected from the patient immediately.

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 NIBP 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, the ViSi Mobile Cuff Module, or the ViSi Power
Pack into the ViSi Mobile Charger while connected to a patient.

15

Warnings

Do not clean the ViSi Mobile Monitor, Cuff Module, Chest Sensor, Thumb Sensor, or
ViSi Power Pack with detergents while worn by the patient.

Do not place the ViSi Mobile Monitoring System or ViSi Power Pack on or over an
implanted programmable medical device.

When the “Monitor Too Hot” alarm is in progress, the ViSi Mobile Monitor and Chest
Sensor should be removed from the patient immediately. Leaving them on the patient
for an extended period of time may lead to a skin burn.

When the “Cuff Battery Temp” alarm is in progress, the ViSi Mobile Cuff Module should
be removed from the patient immediately. Leaving it 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 and any packaging
material after use per your facility’s policy or national requirements.

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 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 provided by Sotera Wireless, Inc. for
the ViSi Mobile Monitoring System. The Chest Sensor 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

16

Warnings

The ViSi Mobile Thumb Sensor is intended for use on the patient’s thumb, index and
middle finger for SpO

measurements; however, cNIBP can only be measured while on

2

the patient’s thumb.

Warnings

Inspect the patient’s skin at the sensor site per your facility’s protocol. If the skin surface
has been compromised, reposition the ViSi Mobile Thumb Sensor or move the Thumb
Sensor to the patient’s other thumb. If the thumb sensor is moved to the other thumb,
move the other sensors as well.

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

measurement.

2

The Thumb Wrap should securely hold the ViSi Mobile Thumb Sensor in place without
impairing circulation. Immediately loosen the Thumb Wrap if the patient complains of
pain, tingling, or numbness in the affected thumb.

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”.

ViSi cNIBP has not been evaluated in patients with pacemakers that pace the ventricle.
ViSi’s NIBP may be used instead.

After monitoring has been stopped on the ViSi Mobile Monitor, and the patient has been
removed from the Remote Viewer, this action cannot be undone. Once removed, the
patient’s monitoring session data will no longer be available on the Remote Viewer.

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, Inc. 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.

17

Warnings

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.

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 blood pressure measurements (NIBP and cNIBP) have not been clinically evalu­ated in the presence of atrial or ventricular arrhythmias. Use alternative BP methods if these
arrhythmias are present.

18

Chest Sensor: 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 provide 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.

Warnings

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.

Warnings

Impedance pneumography for the determination of respiration (RESP) is not
recommended for use in the presence of mechanically induced, high frequency

ventilation.

19

Warnings

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.

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 (1-time measurements or continuous measurements)
have not been clinically evaluated in the presence of atrial or ventricular arrhythmias.
Use alternative BP methods if these arrhythmias 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 conditions, including direct sunlight, may interfere with the
performance of the ViSi Mobile Thumb Sensor.

Warnings

Low perfusion, electrosurgical devices, dysfunctional hemogolobin, the presence of
certain dyes and inappropriate positioning of the ViSi Mobile Thumb Sensor may result
in erroneous measurements.

20

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.

Warnings

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 (artifacts) 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 when it 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, you are testing how the
alarm and alert tones will sound at the Remote Viewer during typical operation. If the
volume is inadequate, clinicians could miss alarms and alerts. During testing, if the tone
does not sound or it is not loud enough, adjust the speaker volume.If the sound is still
not loud enough, immediately contact a biomedical engineer.

The ViSi Power Pack Alarms/Alerts DO NOT audibly annunciate on the ViSi Mobile
Monitor or the Remove Viewing Device.

Warnings

If the ViSi Mobile Monitor displays a “Battery Pack Fault” , “Electric Shock”, or “Monitor
Too Hot” message, disconnect the Power Pack immediately.

21

Warnings

User Maintenance

To avoid contaminating or infecting personnel, the environment or other equipment, make
sure to disinfect and decontaminate the ViSi Mobile Monitoring System, Thumb Sensor and
disposables appropriately before disposing of them in accordance with your country’s laws
for equipment containing electrical and electronic parts.

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.

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.

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.If you have any concerns
regarding a cyber security breach or vulnerability, contact Sotera Wireless, Inc. or an
authorized Sotera Wireless, Inc. representative in your area.

Wireless Communications

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.

22

2.3 Cautions

Intended Use

Federal (U.S.A.) law restricts the ViSi Mobile Monitoring System and Power Pack 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

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.

Cautions

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).

Only the ViSi Power Pack should be placed into the accompanying cradle.

To avoid damage, the ViSi Power Pack should only be connected to the ViSi Mobile
Monitor.

Monitoring

The accuracy of cNIBP is dependent on the initial cuff calibration. Use good clinical
practice to confirm cNIBP accuracy before initiating or treating a patient.

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 of up to 120 seconds between the
instantaneous blood pressure reading and the displayed reading.

The ViSi Mobile Monitoring System accuracy claim (mean error of ≤ ±5 mmHg and a
std. dev. of ≤ 8 mmHg) is not met when the subject is in a semi-Fowlers position
(inclined more than 30 degrees from horizontal).

®

23

Cautions

2-way radios may cause waveform distortion when placed within 1 foot of the ViSi
Mobile Monitor.

Some brands of television may cause temporary waveform distortion and data loss when placed
within 6 feet of the ViSi Mobile Monitor.

Safety

The ViSi Mobile Monitoring System or Power Pack have not been tested in the
presence of flammable anesthetics or other flammable agents in combination with air,
nitrous oxide, or oxygen-enriched environments.

Do not use a ViSi Mobile Monitor, its components, Power Pack or other 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 or ViSi
Mobile Cuff Module, or ViSi Power Pack 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 or Power Pack are not intended for home use.

Do not use the ViSi Mobile Monitoring System or Power Pack 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 or Power Pack.

Using accessories other than those specified may result in increased electromagnetic
emission or decreased electromagnetic immunity of the monitoring equipment.

Changes in posture and arm height can affect ViSi cNIBP accuracy. If the cNIBP
measurement is questionable, retake the measurement. Ideally recalibrate in the same
position as the initial calibration.

24

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 the administration of an IV vasoactive drug
or a new oral vasoactive drug. The Calibrate cNIBP alert will not be displayed.

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 Customer Service.

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.

Cautions

The ViSi Mobile Monitoring System components, including the ViSi Power Pack 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, with the round end pointing 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.

Cautions

To avoid damage from dropping the ViSi Mobile Monitor while it is connected to the
patient, secure the ViSi Mobile Monitor by plugging in the thumb sensor or locking key.

The performance of the automated sphygmomanometer may be affected by extremes
of temperature, humidity and altitude.

25

Cautions

The ViSi Mobile Monitoring System 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).

When using a ViSi Power Pack equipped with a mount, ensure the clamp is properly
secured to the bedside or IV Pole to avoid damage from being dropped.

Avoid from putting the ViSi Power Pack directly below an IV bag.

Avoid putting anything other than the ViSi Power Pack into the cradle.

Route the ViSi Power Pack cable away from other medical equipment in its vicinity.

Cleaning / Disinfecting

Do not clean the ViSi Mobile Monitor, the Cuff Module, or the Power Pack while it is
plugged into the ViSi Mobile Charger.

Do not apply liquid to the ViSi Mobile Cuff Module or the Power Pack. To clean, use a
damp cloth.

Ensure the sensor connector contacts are thoroughly dried to prevent possible
malfunction.

Thumb sensors which are saturated with liquid should be allowed to air dry thoroughly
before re-use.

Do not use bleach, 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. See page 107

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 or
the ViSi Mobile Thumb Sensor.

Cautions

After patient use, the disposables from the ViSi Disposable Kit may contain bio-hazard
materials. Handle and dispose of these items according to your facility’s policies.

When the ViSi Mobile Cuff Module is connected to the other ViSi Mobile Components,
the entire system has an ingress protection rating of IPX0.

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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.

27

Notes

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