Sotera Wireless VISI-MOBILE ViSi Mobile Monitoring System User Manual RVD IFU

Sotera Wireless, Inc. ViSi Mobile Monitoring System RVD IFU

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User Manual

1Remote ViewerUser manualFebruary 2014Reference Number (USB): 95-10134Reference Number (Hardcopy): 95-10101Part Number: 6-000210-09.39444 Waples Street, Suite 280 San Diego, California 92121 USAPhone: +1 (866) 232-6126 (U.S.)+1 (858) 427-4620 (Intl)Fax: +1 (858) 427-4639Email: support@soterawireless.comEMERGO EUROPEMolenstraat 15, 2513BHThe HagueThe NetherlandsFor additional information or assistance, please contact Sotera Wireless or an authorized Sotera Wirelessrepresentative in your area.0297

3ContentsChapter 1. Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Chapter 2. Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Chapter 3. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Areas on the ViSi Mobile Remote Viewer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Care Unit Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Work Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Patient Home View and Other Patient Views. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Patient Tiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Care Unit Patient Tiles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Patient Tiles in the Assigned Location Zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Patient Tiles in the Unassigned Location Zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Work Area Patient Tiles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Patient Tile in the Patient Home View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Patient Tiles in Other Patient Views. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Navigating to a Patient Home View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33To navigate to a Patient Home View from the Care Unit Area. . . . . . . . . . . . . . . . . . . . . . . . 33To navigate to the Patient Home View from another patient view . . . . . . . . . . . . . . . . . . . . 34System Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35To access the system help. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Shutdown the Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36To shutdown the application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Chapter 4. Wireless Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Wireless Monitoring with ViSi Mobile Remote Viewer . . . . . . . . . . . . . . . . . . . . 37

4Communication with ViSi Mobile Remote Viewer . . . . . . . . . . . . . . . . . . . . . . . . 38Monitoring a patient outside of network range . . . . . . . . . . . . . . . . . . . . . . . . . . 39Chapter 5. Setting Up Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Admit New Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41To admit a new patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Start Monitoring Before Admit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43To start monitoring before admit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Editing Patient Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45To edit patient information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Designating Patient Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Dragging and Dropping to a New Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47To drag and drop a Patient Tile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Entering Location Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48To enter location information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48ADT Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50To Select Patients from ADT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50Chapter 6. Patient Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Viewing Vital Sign Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Vital Sign Measurements Displayed in the Care Unit Area . . . . . . . . . . . . . . . . . . . . . . . . . . 53To view one patient’s measurements in a patient view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55Viewing Graphical Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Viewing all Vital Sign Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57To view vital sign trends in graphical format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Viewing a Single Vital Sign Trend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58To view a single vital sign trend in graphical format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Graphical Trend Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Time scale Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Trend Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Time Cursor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Patient Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Alarm/Events Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Viewing List Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62To view vital sign trends in tabular format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63List Trend Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64Trend Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64Navigation/Scrolling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64Viewing Current Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65Viewing ECG Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65To view a patient’s current ECG waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65Input Overload/Dynamic Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66Patient Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67List Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67To Print the List Trends Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

5Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68To Print the Waveform Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68Chapter 7. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69System Alarm Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69General Alarm Management Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69In Network Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70Physiological Alarms (Alarms) / Technical Alarms (Alerts) Summary . . . . . . . 71Responding to Alarms/Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71Managing Alarm/Alert Annunciations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72Responding to Physiological Alarms (Alarms) . . . . . . . . . . . . . . . . . . . . . . . . . . 73To Silence/Acknowledge Life Threatening Severity Alarms . . . . . . . . . . . . . . . . . . 73To Silence High Severity Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75Responding to Equipment Alarms (Alerts) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77To Silence/Acknowledge Alerts (All Severities) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77Resume / Turn On Alarm Annunciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79To Resume Alarm Annunciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79To Turn On Alarm Annunciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80Manage Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81To change alarm limits individually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81To reset alarm limits to default values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83ViSi Mobile Remote Viewer Audio Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84To test the ViSi Mobile Remote Viewer Speaker. . . . . . . . . . . . . . . . . . . . . . . . . . . . 84Chapter 8. Pause / Stop Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Pause Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Stop Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87Removing Patients from the Care Unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88To remove a patient from the Care Unit View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88Chapter 9. Care Unit Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91Care Unit Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91To view the ViSi Mobile Monitors currently in use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91Chapter 10. Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Customer Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93ViSi Mobile Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94Screen Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94ViSi Mobile Chest Sensor Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95ViSi Mobile Thumb Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

6ViSi Mobile Cuff Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99ViSi Mobile Battery Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101General Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102Connectivity Lost. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102Alarms and Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102ViSi Mobile Remote Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104Setting Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104Chapter 11. Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105Vital Sign Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106Heart Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106Respiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109Pulse Oximetry (SpO2, Functional Oxygen Saturation). . . . . . . . . . . . . . . . . . . . . 110Non-Invasive Blood Pressure (NIBP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112Continuous Non-Invasive Blood Pressure (cNIBP) . . . . . . . . . . . . . . . . . . . . . . . . 114Skin Temperature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117Physical Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118ViSi Mobile Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118Wireless Communications / Radio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118Mode Plugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119ViSi Mobile Chest Sensor Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120ViSi Mobile Cuff Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121ViSi Mobile Thumb Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122ViSi Mobile Charger - 8 Bay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123ViSi Mobile Charger - 2 Bay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123ViSi Mobile Appliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124ViSi Mobile Remote Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125Customer Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126Alarms / Alerts Annunciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127Physiological Alarms (Alarms) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127Visual Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127Audio Tones. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127Equipment Alarms (Alerts) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130Visual Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130Audio Tones. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130Environmental Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131Compliances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133Federal Communications Commission (FCC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133Electromagnetic Compatibility (EMC) Specifications. . . . . . . . . . . . . . . . . . . . . . . 134Accessories Compliant with EMC Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136Recommended Separation Distance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137From Portable and Mobile RF Communication Equipment . . . . . . . . . . . . . . . . . . . . . . . . . 138Electrosurgery Interference/Defibrillation/Electrostatic Discharge . . . . . . . . . . . . . . . . . . . . 138

7Fast Transients/Bursts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139Wireless Network Risk Mitigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140Risk Analysis Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140Residual Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140Sotera Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140Responsible Organization Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140Appendix A. Alarm Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143Patient Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143Life Threatening Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143High Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144Equipment Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145ViSi Mobile Monitor Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145ViSi Mobile Chest Sensor Cable and ECG Alerts . . . . . . . . . . . . . . . . . . . . . . . . . 146ViSi Mobile Thumb Sensor and SpO2 Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147ViSi Mobile Cuff Module and NIBP Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147Miscellaneous Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149ViSi Mobile Charging Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149ViSi Mobile Monitor Status Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150Battery Charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150Wireless Radio Signal Strength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150Appendix B. Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151Alarms / Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151Alarm / Alert States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151Alarm Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152Battery States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153General Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154Out of Range Vital Signs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154Navigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154Vital Signs Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154Clinical Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156Patient’s Postures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157Unknown Posture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157Postures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157Labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158Appendix C. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161Third Party Branded Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161Warranty Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

8Sotera Wireless Responsibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162Contact Sotera Wireless . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

91. Preface1.1 IntroductionThe suite of ViSi Mobile Monitoring System™ user manuals are intended to provide information for theproper operation of the Sotera Wireless ViSi Mobile Monitoring System™. The suite of manualscomprises of:• ViSi Mobile Monitoring System User Manual• ViSi Mobile Remote Viewer User Manual• ViSi Mobile myRemote Viewer User Manual1A formal knowledge of patient monitoring and an understanding of the features and functions of thesystem are prerequisites for its proper use.These manuals are written for trained clinicians. Although the manuals describes guidelines for optimizingmonitoring techniques, clinicians using this system should be trained to take and interpret patient vitalsigns. Automatic vital signs monitoring is an adjunct to clinical assessment; good clinical judgment shouldalways prevail.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 Man-ual 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 mit-igations, EMC standards compliance and warnings about possible effects from RF sources in the vicinity of the device.Do not operate the ViSi Mobile Monitoring System before reading theseinstructions.

Intended Use 101.2 Intended UseThe ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel forsingle or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated forECG (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 ofarterial hemoglobin (SpO2), pulse rate, and skin temperature in hospital-based facilities; including generalmedical-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 MobileRemote Viewer through wireless 802.11 communication.1.2.1 Contraindications• Impedance pneumography for the determination of Respiration Rate (RESP) is not recommendedfor 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 patientsunder the age of 18 years.• Do not use the same ViSi Mobile Monitor System to measure the NIBP of one patient while it isconnected simultaneously to another patient.• Do not use the ViSi Mobile Monitor on a patient with an Intra-Aortic Balloon Pump (IABP), or aLeft Ventricular Assist Device (LVAD). The Monitor requires an unperturbed arterial pulsewaveform for non-invasive blood pressure calculations. IABP and LVAD perturb the arterial pulsewaveform.• 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 cuffis 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 beenestablished in the presence of any dysrhythmias.

112. Warnings and Cautions2.1 IntroductionPlease read and adhere to all warnings, cautions and notes listed here and in the associated sectionsthroughout 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 resultin injury to a person, or serious adverse events associated with the use ormisuse of the ViSi Mobile Monitoring System.Caution statements alert the user to conditions or practices that could resultin problems with the ViSi Mobile Monitoring System associated with its useor misuse.Note: Note statements provide supplemental information to the user.

Warnings 122.2 Warnings Intended UseDo not use the ViSi Mobile Monitoring System outside the intended use described inthis 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 underthe 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.SafetyDo 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 vicinityof/or on a patient being monitored with a ViSi Mobile Monitoring System. Observe thepatient closely while electrosurgery is in use.To ensure patient safety, use only components and accessories recommended orsupplied by Sotera Wireless, Inc. Accessories must always be used in accordance withyour facility’s policies and the manufacturer’s recommendations.Use only the AC adapter recommended for the ViSi Mobile Charger. Use of other ACadapters may result in damage to the unit.There may be a possible hazard caused by the summation of leakage currents whenseveral items of equipment are interconnected.The ViSi Mobile Monitoring System has not been tested in the presence of flammableanesthetics or other flammable agents in combination with air, nitrous oxide, or oxygen-enriched environments.Route the patient cabling to avoid the possibility of patient entanglement orstrangulation.To ensure patient safety, the conductive parts of the ECG electrodes, includingconnectors and other patient-applied components, should not contact other conductiveparts, 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 rechargethe battery, disconnect the Cuff Module from the patient, and then place it in the ViSiMobile Charger.

Warnings13Warnings To prevent possible cross-contamination, properly clean and disinfect all reusablecomponents between patients.The ViSi Mobile Monitor should never be used to measure the NIBP of one patient whilethe Monitor is simultaneously connected to another patient.Do not attempt to take NIBP measurements with the ViSi Mobile Monitor while thepatient is undergoing cardio-pulmonary bypass.Do not attempt to take NIBP measurements with the ViSi Mobile Monitor while thepatient 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 aresult of measurements made too frequently. Loosen or remove the ViSi MobileDisposable 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 MobileCharger while connected to a patient.Never connect the ViSi Mobile Monitor directly to an AC power outlet. To recharge thebattery, disconnect the Monitor from the patient, and then place it in the ViSi MobileCharger.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 programmablemedical device.When the “Monitor Too Hot” alarm is in progress, ViSi Mobile Monitoring System shouldbe removed from the patient immediately. Leaving on the patient for an extendedperiod of time may lead to a skin burn.When the “Cuff Battery Temp” alarm is in progress, ViSi Mobile Cuff Module should beremoved from the patient immediately. Leaving on the patient for an extended period oftime may lead to a skin burn.Disposable ComponentsAll disposable components of the ViSi Mobile Monitoring System are for single patientuse only. To avoid possible cross contamination, do not reuse any disposable items ona patient other than the original patient. Dispose of the components after use per yourfacility’s policy.

Warnings 14Warnings Patient MonitoringDo 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 Cablemust 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 withoutimpairing circulation. Immediately loosen the Wrist Strap if the patient complains ofpain, tingling, or numbness in the affected hand or wrist.Only use the ViSi Mobile Thumb Sensor provided by Sotera Wireless, Inc. with the ViSiMobile Monitoring System. Using non-approved Thumb Sensors may result ininaccurate SpO2 readings or damaged equipment.The ViSi Mobile Thumb Sensor is intended for use on the patient’s thumb only. Do notapply the Thumb Sensor to the patient’s fingers.Inspect patient’s skin at sensor site per your facility’s protocol. If skin surface has beencompromised, reposition the ViSi Mobile Thumb Sensor or move the Thumb Sensor tothe patient’s other thumb.Ensure the ViSi Mobile Thumb Sensor is securely fastened. A Thumb Sensor that iswrapped too tight or too loose can adversely affect SpO2 measurement.Inspect patient’s skin at sensor site every 8 hours. If skin surface has beencompromised, reposition the ViSi Mobile Thumb Sensor or move the Thumb Sensor tothe patient’s other thumb.The Thumb Strap should securely hold the ViSi Mobile Thumb Sensor in place withoutimpairing circulation. Immediately loosen the Thumb Strap if the patient complains ofpain, tingling, or numbness in the affected thumb.Before monitoring a new patient, ensure all the sensors have been removed and thatmonitoring was stopped using the Stop Monitoring procedure.To prevent settings from being inadvertently changed, lock the ViSi Mobile Monitorscreen (if enabled) as soon as tasks are completed.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 toprovide defibrillation protection as indicated in the Specifications section of thismanual. ViSi Mobile is designed to be compatible with the use of externaldefibrillators.

Warnings15Warnings Keep all pacemaker patients under close or constant observation. Pacemaker signalscan differ among pacemakers, ICDs, or CRT devices. The Association for theAdvancement of Medical Instrumentation (AAMI) cautions: “In some devices, ratemeters may continue to count the pacemaker rate during occurrences of cardiac arrestor some arrhythmias. Do not rely entirely upon rate meter alarms”.Other RF radiating devices (such as high powered RFID readers and Bluetoothdevices) that are in close proximity with the ViSi Mobile Monitor may interfere with theMonitor’s wireless communications. During such interference, the Monitor continues tomonitor and will alarm locally. If wireless communication is affected when using theMonitor in close proximity with another RF radiating device, move the other deviceaway from the Monitor or discontinue use of the other device.After monitoring has been stopped on the ViSi Mobile Monitor, removing the patientfrom the ViSi Mobile Remote Viewer cannot be undone. Once removed, the patient willno longer be available on the Remote Viewer.All wireless devices are susceptible to radio frequency interference that can disruptconnectivity. If excessive ViSi Mobile Monitoring System disconnections are observed,notify your biomedical engineer. Excessive disconnections can cause interruptedpatient 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. Ifthe Remote Viewer display is blank, contact your biomedical engineer immediately forservice.If a ViSi Mobile Monitor or the ViSi Mobile Remote Viewer display screen is scratchedor damaged, immediately send it for servicing. A scratched or damaged screen caninterfere with patient monitoring.Always consult Sotera Wireless before performing any changes to the ViSi MobileAppliance. Server changes can result in communication failure between components ofthe ViSi Mobile Monitoring System. If system communication stops, monitor patients atthe ViSi Mobile Monitors.Perform a risk assessment and verification before implementing a change ormodification to the IT infrastructure. Changes to IT network configurations cancompromise continuous vital signs monitoring and alarm delivery.

Warnings 16Warnings Vital SignsIf a vital signs measurement is questionable, retake the measurement. If the result isstill questionable, use a different method of measurement.ViSi Mobile arterial measurements have not been clinically tested in the presence ofactual or ventricular arrhythmias. Use alternative BP methods if these arrythmias arepresent.Chest Sensor Cable: ECG, Respiration, Temperature (Skin)Use all of the same type of high quality ECG electrodes on the patient. Mixing ECGelectrode types can adversely affect ECG monitoring.Avoid placing the ViSi Mobile Cable Securements and ECG electrodes over areas ofabrasions, irritation, or other sensitive areas. If possible, remove, reposition, andreplace ECG electrodes and Cable Securements if the patient complains of pain/itchingat 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 frequentarrhythmias are suspected, their presence should be confirmed by visual observation ofthe ECG waveform or another method, such as a 12-lead ECG.The ViSi Mobile Monitor does not have automated ST segment analysis, therefore, if achange in the ST segment of the ECG waveform is suspected, it should be confirmedby 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. TheAssociation for the Advancement of Medical Instrumentation (AAMI) cautions: “In somedevices, rate meters may continue to count the pacemaker rate during occurrences ofcardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms”. Allpacemaker patients should be kept under close or constant observation.External pacemakers or other external electrical stimulators may cause the ViSi MobileMonitor to produce erroneous results.RESP (chest wall motion) can continue in the absence of ventilation (obstructedairway). Do not rely on the RESP alone to determine adequacy of ventilation. Othervital signs, such as HR and SpO2, should be assessed as well.TEMP monitoring with the ViSi Mobile Monitoring System is intended for trendingpurposes only and is not intended to replace core temperature monitoring. Beforemaking clinical decisions based on the skin temperature measurement, verify themeasurement using another clinically acceptable method of core temperaturemeasurement.

Warnings17Warnings Impedance pneumography for the determination of respiration (RESP) is notrecommended for use in the presence of mechanically induced, high frequencyventilation.Cuff Module / NIBPViSi Mobile Disposable Cuffs are for single patient use only. To avoid possible crosscontamination, 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 Modulewhile not impairing circulation when deflated.Avoid applying the ViSi Mobile Disposable Cuff over a wound as this can cause furtherinjury.Avoid applying the ViSi Mobile Disposable Cuff on any limb where intravascular accessor therapy, or an arterio-venous (A-V) shunt, is present because of temporaryinterference 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 Cuffto an arm on the same side of a mastectomy. Recommend using the ViSi MobileMonitoring System on the opposite arm.ViSi Mobile NIBP measurements have not been clinically tested in the presence ofactual or ventricular arrhythmias. Use alternative BP methods if these arrythmias arepresent.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.SpO2Oxygen saturation measurements using SpO2 are dependent on proper sensorplacement, exposure to ambient light conditions, and general patient conditions. Beforemaking clinical decisions based on SpO2 measurements, verify the measurement usinganother clinically acceptable method, such as arterial blood gas analysis.High ambient light condition, including direct sunlight, may interfere with theperformance of the ViSi Mobile Thumb Sensor.Low perfusion, electrosurgical devices, dysfunctional haemoglobin, the presence ofcertain dyes and inappropriate positioning of the ViSi Mobile Thumb Sensor may resultin erroneous measurements.

Warnings 18Warnings Alarms / AlertsWhen alarms are paused, there is no notification of a potentially clinically significantchange in the patient's vital signs. Observe the patient by other means when alarms arepaused.When alarms are turned OFF, there is no notification of a potentially clinically significantchange in the patient's vital signs. Observe the patient by other means when alarmlimits are set to OFF.Once Auto Set is selected (on the ViSi Mobile Monitor), review the newly calculatedalarm limits carefully before deciding to confirm or cancel the new alarm limits. Oncenew alarm limits are confirmed on the ViSi Mobile Monitor, they cannot be changedback to the original pre-set limits from the ViSi Mobile Monitor. Use the ViSi MobileRemote 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 ViSiMobile Appliance, the ViSi Mobile Remote Viewer does not receive patient alarms oralerts 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 nothave an audible component.Line isolation monitor transients may resemble actual cardiac waveforms and inhibitheart rate alarms. Ensure correct electrode placement and cable arrangement tominimize line isolation monitor transients.To avoid possible hearing damage, do not place your ear too close to the ViSi MobileMonitor that is alarming audibly.When the ViSi Mobile Monitor alarms or alerts, check the patient first to confirm thatthere is no immediate danger to the patient.When testing the speaker at the ViSi Mobile Remote Viewer, if the tone does not soundor it is not loud enough check the speaker volume is turned up. If the sound is still notsound loud enough, immediately contact a biomedical engineer. The test indicates howalarm and alert tones sound at the Remote Viewer. If the volume is inadequate,clinicians could miss alarms and alerts.User MaintenanceTo avoid contaminating or infecting personnel, the environment or other equipment,make sure to disinfect and decontaminate the ViSi Mobile Monitoring Systemcomponents appropriately before disposing of them in accordance with your country’slaws for equipment containing electrical and electronic parts.

Warnings19Warnings Wireless CommunicationsWhen the ViSi Mobile Monitor is not configured to connect to the facility’s network orloses wireless connection to the ViSi Mobile Appliance, the ViSi Mobile Remote Viewerdoes not receive patient alarms or alerts from the ViSi Mobile Monitor.If you have any concerns regarding a cyber security breach or vulnerability, contactSotera Wireless or an authorized Sotera Wireless representative in your area.Off-The-Shelf (OTS) SoftwareThe 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 anincreased risk to users and patients. Customer installed virus protection software willbe permitted on the ViSi Mobile Remote Viewer but not permitted on the ViSi MobileAppliance.

Cautions 202.3 Cautions Intended UseFederal (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 monitoringhas not been established in pregnant, including pre-eclamptic, patients.GeneralWhen 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 isrecommended that you follow the correct stop/pause monitoring flows.When monitoring has been paused, monitoring may only be resumed using the sameViSi Mobile Monitor. If you place the ViSi Mobile Monitor into the Charger with otherMonitors, label the Monitor so that is can be identified when monitoring is to beresumed.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 MobileRemote Viewer.When the wireless connector symbol is yellow, the ViSi Mobile Monitor is unable toconnect to the ViSi Mobile Remote Viewer (via the ViSi Mobile Appliance).SafetyThe ViSi Mobile Monitoring System has not been tested in the presence of flammableanesthetics or other flammable agents in combination with air, nitrous oxide, or oxygen-enriched environments.Do not use a ViSi Mobile Monitor, its components, or accessories that appeardamaged. Inspect all reusable components for damage before each use.Do not attempt to connect any patient worn component, ViSi Chest Sensor Cable orViSi Mobile Cuff Module to an electrical outlet of any kind.A component that has been dropped or severely abused should be checked by qualifiedservice 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 wetenvironment, such as a shower.

Cautions21Cautions Explosion Hazard. Do not use in the presence of a flammable anesthetic mixture withair, or with oxygen or nitrous oxide.Use care when using automatic cuff inflation for prolonged periods on unconscious orsemi-conscious patients since the patient may not be able to alert the clinician to anypain he/she may be experiencing. Pressing the “Stop NIBP” button interrupts the NIBPmeasurement and deflates the cuff.Consult your Biomed department or vendors for assistance in identifying EMCcompliance status of other medical devices when using the ViSi Mobile MonitoringSystem.Using accessories other than those specified may result in increased electromagneticemission or decreased electromagnetic immunity of the monitoring equipment.Changes in posture can affect ViSi cNIBP accuracy. Recalibrate ViSi cNIBP whenevertorso changes by more than 30o above supine position.The accuracy of the cNIBP measurement cannot be relied upon in patients with a BMIgreater than 35.Due to cNIBP signal averaging, there is a time delay between the instantaneous bloodpressure reading and the displayed reading.You should manually recalibrate cNIBP after any drug administration. The CalibratecNIBP alert will not be annunciated.If using the ViSi Mobile Monitor with any other monitor on the same patient, check thateach monitor does not interfere with the operation of the other. If interference isdetected, remove one or more of the sensors until there is no longer any interference.Service / MaintenanceIf the ViSi Mobile Monitor detects an unrecoverable problem, an error messagecontaining the error number is displayed. Remove the Monitor from use and report theerror to Sotera Wireless, Inc.When the ViSi Mobile Monitor is in the Charger and a charging alert occurs, remove theMonitor from service.General maintenance of the ViSi Mobile Monitoring System should be conducted at thehospital defined intervals.The ViSi Mobile Monitoring System components should only be serviced by SoteraWireless, Inc. technicians or authorized service providers.

Cautions 22Cautions Equipment / ComponentsIf the ViSi Mobile Monitor is to be stored for an extended period of time, it isrecommended the Monitor be stored with the Shipping Plug inserted to reduce thebattery discharge. The ViSi Mobile Monitor must always have the Shipping Pluginserted when shipped by a common carrier to comply with Federal Regulationsregarding 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 ensureaccurate NIBP measurements. A Cuff that is too small can result in a falsely high NIBPmeasurement. 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 themeasurement.To avoid damage from dropping the ViSi Mobile Monitor, ensure that the Wrist Strap issnugly wrapped around the wrist.To avoid damage from dropping the ViSi Mobile Monitor, make sure that the Monitor issecurely snapped into the ViSi Mobile Wrist Cradle.The performance of the automated sphygmomanometer may be affected by extremesof temperature, humidity and altitude.The ViSi Mobile Monitor may not perform to specification if stored or shipped outsidethe specified temperature range.The ViSi Mobile Monitor may be temporarily interrupted by UHF RFID Systems (860-960MHz).Cleaning / DisinfectingDo not clean the ViSi Mobile Monitor or the Cuff Module while it is plugged into the ViSiMobile 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 possiblemalfunction.Thumb sensors which are saturated with liquid should be allowed to air dry thoroughlybefore re-use.Do not use abrasive cleaning agents or organic solvents on any of the ViSi MobileMonitoring System components.

Cautions23Cautions Use only recommended cleaning / disinfecting agents to prevent damage to the deviceand 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 SensorCable or the ViSi Mobile Thumb Sensor.After patient use, the disposables from the ViSi Disposable Kit may contain bio-hazardmaterials.When the ViSi Mobile Cuff Module is connected to the other ViSi Mobile Components,the entire system has an ingress protection rating of IPX0.

Notes 242.4 NotesNote: Figures in this manual are provided for reference purposes only. Screens may differ based onthe monitoring device configuration, licenses available, parameters selected and patientconfiguration of the ViSi Mobile Monitoring System.Note: All ViSi Mobile Monitoring System alarms and alerts annunciate with icons and colors thatcomply with IEC 60601-1-8.

253. OverviewThe ViSi Mobile Monitoring System enables clinicians to remotely monitor patients who are connected toViSi Mobile Monitors. A system includes ViSi Mobile Monitors (see 95-10134), a ViSi Mobile Applianceand 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 MobileRemote 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 notificationsViSi Mobile Monitoring System

Areas on the ViSi Mobile Remote Viewer 263.1 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 AreaThe 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 MobileRemote Viewer can vary.Patient TilesPatient TilesAssigned Location Zone Unassigned Location ZoneCare Unit Area

Areas on the ViSi Mobile Remote Viewer273.1.2 Work AreaViews 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 onpage 28). From the Patient Home View, touch or click tabs to navigate to other views for the selectedpatient.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 unitTo open patient views for a different patient, touch or click the patient’s Patient Tile. To close all patientviews and return to a blank Work Area, touch or click the currently selected Patient Tile.Work Area

Areas on the ViSi Mobile Remote Viewer 28Patient Home View and Other Patient ViewsWhen a Patient Tile in the Assigned Location Zone or Unassigned Location Zone is touched or clicked, thepatient 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 unitSelected patient’s Patient Home ViewSelected Patient Tile(Work Area)MenuPatient Tabs

Patient Tiles293.2 Patient TilesPatient Tiles appear in the Care Unit Area and in the Work Area. 3.2.1 Care Unit Patient TilesPatient Tiles in the Assigned Location ZonePatient Tiles in the Assigned Location Zone vary in size, depending on your care unit configuration.Patient’s Vital Sign Patient Posture/Status (ViSi Man™) /ViSi Mobile Monitor Status- Monitor NumberMeasurements Equipment StatusOR- Network Connection Strength- Battery Status

Patient Tiles 30Patient Tiles in the Unassigned Location ZoneThe Unassigned Location Zone of the Care Unit Area holds Patient Tiles for patients that have not beenassigned a room/bed.Note: When a patient has been selected from either the Assigned Patients or the UnassignedPatients Zones, the Unassigned Patients Zone will be condensed to provide enough room todisplay the selected patient’s details.Patient’s Vital Sign Patient Posture/Status (ViSi Man™) /Measurements Equipment StatusViSi Mobile Monitor Status- Monitor Number- Network Connection Strength- Battery Status

Patient Tiles313.2.2 Work Area Patient TilesPatient views in the Work Area include a Patient Tile similar to tiles in the Care Unit Area, but patient viewtiles also show alarm limits and patient information. Patient Tile in the Patient Home ViewPatient’s Vital SignPatient Posture/Status (ViSi Man) /MeasurementsEquipment StatusViSi Mobile Monitor Status- Monitor Number- Network Connection Strength- Battery StatusPatient InformationAlarm Limits

Patient Tiles 32Patient Tiles in Other Patient ViewsIn other patient views, vital sign measurements appear on the right side of the view.Vital sign measurementsand alarm limits

Navigating to a Patient Home View333.3 Navigating to a Patient Home ViewNavigation to a patient’s Patient Home View is permissible from any location.To navigate to a Patient Home View from the Care Unit AreaFrom anywhere in the Care Unit Area (Assigned Location Zone or Unassigned Location Zone), touch or click a Patient Tile.The Patient Tile will display as “selected” and the patient’s Home Page view will be displayed inthe Work Area.Selected patient’s Patient Home ViewSelected Patient Tile(Work Area)Patient Tabs

Navigating to a Patient Home View 34To navigate to the Patient Home View from another patient viewWhen the Work Area is already open for the desired patient, touch or click the Patient Home Tab.The patient’s Home Page view will be displayed in the Work Area.“Patient Home” Tab

System Help353.4 System HelpThe System Help View may be used to identify which software release is currently in use.To access the system helpIn the System Toolbar, touch or click the System Help button. The System Help screen will be displayed in the Work Area.

Shutdown the Application 363.5 Shutdown the ApplicationTo shutdown the application1. In the System Toolbar, touch or click the Main Menu button.The main menu will be displayed in the Work Area.2. Touch or click the Shut Down Application menu option.The clinician will be prompted to confirm they wish to shut down the application.3. Touch Shut Down to shut down the application. The application will shut down.-or-Touch Cancel to cancel the shut down request. The Shut Down Application menu option will no longer be selected and the shut down request willbe cancelled.When the application is shutdown, remote monitoring will not be available.

374. Wireless Monitoring4.1 Wireless Monitoring with ViSi Mobile Remote ViewerViSi Mobile Monitors can operate either as standalone devices or in communication with the ViSi MobileRemote Viewer through the ViSi Mobile Appliance. While the ViSi Mobile Monitor is connected to thenetwork, patient data gathered by the monitor is continuously stored by the ViSi Mobile Appliance. Thisdata is accessible from the ViSi Mobile Remote Viewer. Additional tasks may be performed remotelyfrom the Remote Viewer:• Review patient data (vital signs, alarm limits, etc)• Edit the patient demographics data (name, date of birth, gender, etc)• Assign a room/bed locationWhen the ViSi Mobile Monitor is not connected or loses wireless connection to theViSi Mobile Appliance, the ViSi Mobile Remote Viewer does not receive patientalarms or alerts from the ViSi Mobile Monitor.

Communication with ViSi Mobile Remote Viewer 384.2 Communication with ViSi Mobile Remote ViewerViSi Mobile Monitor’s wireless networking transmission methods are based on the 802.11b standard. Thisspecification has the marketing name of Wi-Fi. Security is provided by the implementation of WPA2-PSKsecurity protocols. For specifications pertaining to the wireless radio, see section WirelessCommunications / Radio on page 118. The ViSi Mobile Monitor’s wireless communications depends onyour hospital’s IT infrastructure for connectivity to the ViSi Mobile Appliance, where all data from theMonitors are aggregated, stored, and interfaced to external systems. For requirements, see Section11.3.7 ViSi Mobile Appliance on page 124. A risk analysis summary for use by your hospital’s ITdepartment is provided in Section 11.7 Wireless Network Risk Mitigation on page 140 to assist with ISO80001-1 compliance. For additional information or assistance, please contact Sotera Wireless or anauthorized Sotera Wireless representative in your area.The ViSi Mobile Monitor automatically establishes connection whenever the monitor is within range of thenetwork. Verify that the ViSi Mobile Monitor displays the following symbol (in green) to indicate theconnection to the ViSi Mobile Remote Viewer has been established: For information on monitoring vital signs, refer to the ViSi Mobile Monitor User Manual, reference#: 95-10134 (USB). When the wireless connector symbol is yellow, the ViSi Mobile Monitor isunable to connect to the ViSi Mobile Remote Viewer (via the ViSi MobileAppliance).

Monitoring a patient outside of network range394.3 Monitoring a patient outside of network rangeWhile the ViSi Mobile Monitor typically continually communicates with the ViSi Mobile Appliance andViSi Mobile Remote Viewer, occasionally communication may be lost during ambulation or transportoutside the wireless coverage area. When the ViSi Mobile Monitor goes outside of the network range,monitoring continues locally. The ViSi Mobile Monitor provides local Respiration, NIBP, HR/PR andSpO2 alarms and alerts. When this happens an alert occurs at the ViSi Mobile Remote Viewer with themessage “CONNECTIVITY LOST”.When the monitored patient is again within range of the network, the ViSi Mobile Monitor automaticallyreconnects to the network and wireless monitoring resumes. Be aware that it can take a few minutes torestore communication with the network and resume the communication of patient vital signs data.Moving the ViSi Mobile Monitor out of the network range will break the radiolink, immediately stopping communication of patient vital signs data to theViSi Mobile Remote Viewer.

Monitoring a patient outside of network range 40- Notes -

415. Setting Up Monitoring5.1 Admit New PatientA new patient may be admitted to the ViSi Mobile Monitor / Remote Viewer before monitoring has beenstarted.To admit a new patient1. In the System Toolbar, touch or click the Main Menu button.The main menu will be displayed in the Work Area.2. Touch or click the Admit New Patient menu option.The Admit New Patient pane will be displayed in the Work Area. From the Admit New Patientpane, the patient’s demographics and room/bed location may be assigned.

Admit New Patient 423. In the Admit New Patient pane, select the ViSi Mobile Monitor by its ID# and enter the patient’sdemographics. When the ViSi Mobile Monitor has been selected and at least one ID field (patient’s name, MRN#or ID#) the Save button will be enabled.Note: The ID# is located on the Monitor Status screen in the top row of the display.4. Touch or click Save to confirm the changes.-or-Touch or click Cancel.If cancelled, no changes will be saved and the Admit New Patient pane will be closed.If saved, the Patient Tile will be displayed with the message “Monitoring Paused”. If a room/bedwas selected, the Patient Tile will be displayed in the Assigned Location Zone. If no room/bed wasselected, the Patient Tile will be displayed in the Unassigned Location Zone. See 8.1 PauseMonitoring on page 85.5. Go to the bedside and place the ViSi Mobile Monitor on the patient, and apply sensors.The Patient Tile will automatically display the patient’s vital signs.Patient Tile in Assigned Location Zone Patient Tile in Unassigned Location Zone

Start Monitoring Before Admit435.2 Start Monitoring Before AdmitMonitoring of a patient may be started before the patient is admitted through the ViSi Mobile RemoteViewer. When a ViSi Mobile Monitor begins monitoring before the patient is admitted (through theRemote Viewer), the Remote Viewer shows the patient’s active data in the Unassigned Location Zone ofthe Care Unit Area. Note: Adjusting alarm limits is covered in section Manage Alarm Limits on page 81.To start monitoring before admit1. Place the ViSi Mobile Monitor on the patient, and apply sensors.A Patient Tile will automatically appear in the Unassigned Patients Zone.Patient will appear in theUnassigned Location Zone

Start Monitoring Before Admit 442. At the ViSi Mobile Remote Viewer, touch or click the patient’s Patient Tile in the UnassignedLocation Zone.The Patient Tile will display as “selected” and the patient’s Home Page view will be displayed inthe Work Area.3. Navigate to the patient’s Demographics pane and enter the demographic information (forinstructions, see Editing Patient Demographics on page 45).Demographicsnot yet entered

Editing Patient Demographics455.3 Editing Patient DemographicsThe Demographics pane may be used to edit information for a patient being monitored by the ViSi MobileMonitoring System.To edit patient information1. Navigate to the patient’s Patient Home View (for instructions, see Navigating to a Patient HomeView on page 33).The Patient Tile will display as selected and the patient’s Home Page view will be displayed in theWork Area.2. In the Patient Demographics Zone in the Patient Home View, touch or click Edit.-or-Touch or click the Edit/Remove Patient menu option followed by the Edit Patient menu option.The patient Demographics pane will be displayed in the Work Area. From the Demographicspane, the patient’s demographics and assigned room/bed may be modified.EditMenu options:- Edit / Remove Patient- Edit PatientSaveCancel

Editing Patient Demographics 463. In the Demographics pane, add or change patient information.When any field within the Demographics pane has been modified, the Save button will be enabled.4. Touch or click Save to confirm the changes.-or -Touch or click Cancel.If cancelled, no changes will be saved and the Demographics pane will be closed.If saved and modifications were made to any of the patient’s identification fields (Name, MRN# oralternative ID), a popup window will appear on the Remote Viewer with instructions on how tocomplete the patient confirmation process. Additionally, on the ViSi Mobile Monitor, the ConfirmPatient ID screen will be displayed when navigating from the Patient View screen to the Vital Signsscreen.5. On the popup window, touch or click OK.The Patient Tile will display the patient’s primary ID in blue as a reminder that the patient’s IDmust be confirmed at the patient’s bedside (on the ViSi Mobile Monitor).If a room and bed were entered, the Patient Tile will move from the Unassigned Location Zone tothe Assigned Location Zone. 6. Go to the bedside, wake up the ViSi Mobile Monitor, unlock the Monitor and confirm the patient’sID when prompted to do so.The patient’s primary ID and secondary ID will be displayed in white text to indicate confirmationis complete.Note: The patient’s ID will continue to display in blue until the patient’s ID is confirmed on theViSi Mobile Monitor. There is no time limit in which you much confirm the patient’s ID.Instructions on the Remote Viewer Confirmation on the Mobile Monitor

Designating Patient Locations475.4 Designating Patient LocationsA new location for a patient may be designated in any of these ways:• Drag and drop the patient’s Patient Tile to an unoccupied location in the Care Unit Area.• Enter or change location information in the Demographics pane in the Patient Home View.5.4.1 Dragging and Dropping to a New LocationDrag and drop a Patient Tile in the Care Unit Area to accomplish these tasks:• Move a patient without a room/bed assignment to a room/bed• Move a patient from one location to another location in your care unit• Un-assign a patient’s room/bedTo drag and drop a Patient TileWhile touching or clicking on the patient’s Patient Tile, drag and drop the tile to an unoccupied location in the Care Unit Area.The patient will be moved to the new location.Unoccupied Locations(Assigned Location Zone)Patient Tiles(Unassigned Location Zone)Patient Tiles(Assigned Location Zone)

Designating Patient Locations 485.4.2 Entering Location InformationEnter a patient’s location in the Demographics pane of the Patient Home View.To enter location information1. Navigate to the patient’s Demographics pane (for instructions, see section Editing PatientDemographics on page 45).The patient Demographics pane will be displayed in the Work Area.2. In the Assigned Room/Bed area of the Demographics pane, add or change location information.When any field within the Demographics pane has been modified, the Save button will be enabled.

Designating Patient Locations493. Touch or click Save to complete the move to a new location.-or -Touch or click Cancel.If cancelled, the patient will remain in their original location.If saved the patient’s Patient Tile will move to the newly selected location.

ADT Interface 505.5 ADT InterfaceWhen the ViSi Mobile System interfaces with the facilities ADT system, you will not be able to manuallyenter the patient’s demographic data. You will need to select patients from the ADT system.To Select Patients from ADT1. Navigate to the patient’s Patient Home View (for instructions, see Navigating to a Patient HomeView on page 33).The Patient Tile will display as selected and the patient’s Home Page view will be displayed in theWork Area.2. In the Patient Demographics Zone in the Patient Home View, touch or click Edit.-or-Touch or click the Edit/Remove Patient menu option followed by the Edit Patient menu option.The patient Demographics pane will be displayed in the Work Area.EditMenu options:- Edit / Remove Patient- Edit PatientSaveCancelSearch(ADT)

ADT Interface513. In the Demographics area of the Demographics pane, touch or click the Search button.The ADT Patient Search pane will be displayed.4. In the ADT Search pane, enter the search criteria in the Patient Search field and then touch or clickon the desired patient in the “Results” table. As data is typed into the “Patient Search” field, the “Results” table will automatically update withpatients who match the entered search criteria.5. Touch or click Select to select the highlighted patient.-or-Touch or click the Cancel button.If cancelled, the selected patient will not be displayed in the Demographics area in theDemographics pane.SelectCancelPatient Search

ADT Interface 52If selected, the patient will be displayed in the Demographics area in the Demographics pane.Note: The selected patient is not saved until the Save button is clicked or touched on theDemographics pane.Save

536. Patient Monitoring6.1 Viewing Vital Sign MeasurementsVital sign measurements may be viewed in Patient Tiles.Vital Sign Measurements Displayed in the Care Unit AreaThe Care Unit Area shows Patient Tiles for all patients being monitored by the care unit. Each Patient Tileshows the patient’s vital sign measurements. The Care Unit Area is always visible on the ViSi MobileRemote Viewer.The HR/PR source is as follows:• The HR source is from ECG (ViSi Mobile Chest Sensor Module)• In the absence of an HR source from an ECG, the Pulse Rate (PR) can be measured and displayedfrom the SpO2 channel.• In the absence of an HR source from an ECG and a PR from the SpO2 channel, PR can bemeasured and displayed from the NIBP reading.NIBP measurements will fade to gray after 30 seconds. After 30 minutes, the measurements will no longerbe displayed.The patient’s posture will only be displayed after the user has confirmed the patient’s posture on the ViSiMobile Monitor. Until the patient’s posture has been confirmed, the unknown posture icon will bedisplayed.Note: The vital sign measurements (including the patient’s posture) are refreshed every 3 seconds.

Viewing Vital Sign Measurements 54NIBPHR from ECG NIBP(After 30 seconds)PR fromSpO2PR from NIBP NIBP(Continuous)(Spot Check)Patient’s Posture

Viewing Vital Sign Measurements55To view one patient’s measurements in a patient viewNavigate to the patient’s Patient Home View (for instructions, see Navigating to a Patient Home View on page 33).The patient’s Home Page will be displayed in the Work Area.Note: In the Work Area, only the vital sign measurements for the selected patient will be displayed.Alarm Limits(for each vital sign measurement)

Viewing Graphical Trends 566.2 Viewing Graphical TrendsGraphical Trends is a view of the patient’s vital signs over time displayed in graphical format. There aretrend lines for the five vital signs monitored by the ViSi Mobile Monitor: heart/pulse rate; NIBP;respiration rate; SpO2 and skin temperature. Additionally, there is a status bar that shows either the alarmstatus or a list of events (such as cuff inflation, demographic updates, etc).When navigating to the Graphical Trends view from a non-historical view (such as the Patient Home viewor the Current Waveforms view), the Graphical Trends view will display trends for the last hour and theTime Cursor will be located at tNow - 30 minutes.When navigating to the Graphical Trends view from a historical view (such as List Trends), the GraphicalTrends view will display the previously selected time scale (if applicable) or the most appropriate timescale (if not previously selected). The Time Cursor will be located at the selected time line.

Viewing Graphical Trends576.2.1 Viewing all Vital Sign TrendsTo view vital sign trends in graphical format1. Navigate to the patient’s Patient Home View (for instructions, see Navigating to a Patient HomeView on page 33).The patient’s Home Page will be displayed in the Work Area.2. Touch or click the Graphical Trends Tab.The Graphical Trends View will be displayed in the Work Area.Note: When monitoring is resumed after an interruption in monitoring (such monitoring paused,all sensors being disconnected), the graphical trends view will only display the trend datacollected since the resumption of monitoring until the patient’s identity has been confirmedon the ViSi Mobile Monitor.TimescaleTime cursorGraphical TrendsSelectionTabHigh/low measurement for time period(Shaded area behind trend line)Vital SignTrendPatient Alarms

Viewing Graphical Trends 586.2.2 Viewing a Single Vital Sign TrendTo view a single vital sign trend in graphical format1. Navigate to the Graphical Trends view (see above).The Graphical Trends view will be displayed in the Work Area.2. Touch or click the Vital Sign box.The Graphical Trends View showing the selected vital sign trend will be displayed in the WorkArea.Time ScaleTime CursorGraphical Trends SelectionTabHigh/low measurement for time period(Shaded area behind trend line)Vital SignTrendPatient Alarms

Viewing Graphical Trends596.2.3 Graphical Trend FeaturesTime scale DisplaysClicking on any of the time scale buttons will change the time scale display. There are 5 time scalesavailable: last hour; 12 hours; 24 hours; 48 hours; and 72 hours.When viewing the last hour time scale, the last hour will always end at tNow (or at the time monitoring wasstopped). The trend will automatically update every minute. The trend will not automatically update whenviewing any other timescale.Use the scroll bar to move the trend display either left or right of the current view. The scroll bar is notactive when the last hour timescale is displayed.Clicking on the next/previous alarm buttons will move the trend view to the next/previous alarm and placethe Time Cursor on the alarm event. The next/previous alarm buttons will be disabled when there is nonext/previous alarm.Trend LineEach dot (pixel) along the trend line will display the median vital sign measurement over the time periodthe dot (pixel) represents. The time period represented will change depending on the view currentlyselected. See table below. Each NIBP measurement taken will be represented as follows:• Systolic: Downward arrowhead• Diastolic: Upward arrowhead• MAP: White dot (expanded view only)Behind each trend line, there is a shaded graph representing the minimum and maximum vital signmeasurement during the time period the pixel represents. See High/low measurement for time period labelin the diagram above.The alarm limits for each vital sign are displayed as gray shaded blocks behind the trends lines.Time CursorThe date/time corresponding to the Time Cursor position will be displayed to the right of the “Cursor”label and the vital signs will be displayed to the left of the corresponding trend line.When the Time Cursor has been moved, the time selected will become the central point when switching toone of the other historical views, such as List Trends.Selected View Time PeriodLast Hour 30 seconds12 Hours 12 minutes24 Hours 24 minutes48 Hours 48 minutes72 Hours 72 minutes

Viewing Graphical Trends 60Grabbing and moving the Time Cursor will move it in the direction of the move; the trend display willremain static.Patient AlarmsAlarm event markers will be displayed at the top of their corresponding trend box to indicate when thepatient went into alarm. Double clicking on the alarm event marker will navigate to the List Trends view.Hovering the mouse over the event marker will display the details of the event: alarm type and date/timeof occurrence.Alarm/Events Status BarWhen the “Alarms Status” radio button is selected, the Alarms/Events Status Bar will display the alarmstates:• When no alarms have occurred and alarms are turned on for the duration of the time period forwhich the “Alarm Status” pixels represent, the pixels will be black.• When a life-threatening or high severity alarm occurred during the time period for which the“Alarm Status” pixels represent, the pixels will be red.• In the absence of any alarms, when the alarms are turned off or paused during the time period forwhich the “Alarm Status” pixels represent, the pixels will be orange.Alarm/Events Status Bar

Viewing Graphical Trends61When the “Events” radio button is selected, the Alarm/Events Status Bar will display the patient events:• Start NIBP cuff inflation• Alarms changed• Patient demographics changed• Alarms paused / turned off / resumed• Monitoring paused• Monitoring stopped• All sensors disconnected from the MonitorHovering the mouse over the event marker will display the details of the event: event name and date/timeof occurrence.When multiple event icons overlap, they will be replaced by the “multiple events” icon. Hovering over the“multiple events” icon will display a list of all events.Alarm/Events Status Bar

Viewing List Trends 626.3 Viewing List TrendsList Trends is a view of the patient’s vital signs over time displayed in tabular format. There are columnswithin the List Trends table for the five vital signs monitored by the ViSi Mobile Monitor: heart/pulse rate;NIBP; respiration rate; SpO2 and skin temperature. In addition to the vital sign measurements, the ListTrends table will include events (such as cuff inflation, demographics updates, etc).When navigating to the List Trends view from a non-historical view (such as the Patient Home view or theCurrent Waveforms view), the List Trends view will display trends and events at 30 minute intervals,synchronous to the clock.When navigating to the List Trends view from a historical view (such as Graphical Trends), the List Trendsview will display the previously selected time line in the middle of the trend table. The row associatedwith the selected time line will be highlighted.

Viewing List Trends63To view vital sign trends in tabular format1. Navigate to the patient’s Patient Home View (for instructions, see Navigating to a Patient HomeView on page 33).The patient’s Home Page will be displayed in the Work Area.2. Touch or click the List Trends Tab.The List Trends View will be displayed in the Work Area.Note: When monitoring is resumed after an interruption in monitoring (such monitoring paused,all sensors being disconnected), the list trends view will only display the trend data collectedsince the resumption of monitoring until the patient’s identity has been confirmed on theViSi Mobile Monitor.List Trends EventsTab Display Options Print Report

Viewing List Trends 646.3.1 List Trend FeaturesTrend DisplaysThere are three different trend displays: • When “Show Events Only” is selected, the List Trends table will only display a row for each eventoccurrence.• When “Show Trends & Events” is selected, the List Trends table will display a row of vital signsfor each interval time period selected and a row for each event occurrence.The following events will be displayed within the List Trends table when events are included:• Start NIBP cuff inflation• Alarms changed• Patient demographics changed• Alarms paused / turned off / resumed• Monitoring paused• Monitoring stopped• All sensors disconnected from the MonitorThe data within the List Trends table may be displayed ascending or descending by date/time. To togglebetween descending/ascending, click the column header for either the date and/or time.When displaying trends within the List Trends table, the following intervals are available: 5 minutes; 15minutes; 30 minutes; 60 minutes; 2 hours and 4 hours. Every 30 minutes is the default.Navigation/ScrollingUse the scroll bar or arrow keys, to scroll forward or backwards in time to view the trends/events.Clicking an “alarm” arrow when the next/previous alarm is displayed in the current view, the selection barwill move to the next/previous alarm. When the next/previous alarm is not displayed in the current view,the list view will change such that the alarm event will be displayed in the middle row of the List Trendtable.

Viewing Current Waveforms656.4 Viewing Current Waveforms6.4.1 Viewing ECG WaveformsA patient’s current ECG waveform (generated from one lead) may be viewed.To view a patient’s current ECG waveform1. Navigate to the patient’s Patient Home View (for instructions, see Navigating to a Patient HomeView on page 33).The patient’s Home Page will be displayed in the Work Area.2. Touch or click the Current Waveforms Tab.The Current Waveform View will be displayed in the Work Area.Keep all pacemaker patients under close or constant observation. Pacemakersignals can differ among pacemakers, ICDs, or CRT devices. The Association forthe Advancement of Medical Instrumentation (AAMI) cautions: “In some devices,rate meters may continue to count the pacemaker rate during occurrences ofcardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms”.LeadVoltageLead SelectCurrent WaveformsIndicatorButtonsIndicatorTabPacerSpike

Viewing Current Waveforms 663. (Optional) If the patient is monitored with a 5 lead-wire Chest Sensor Cable:• Touch or click an alternative Lead button to view a waveform derived from a different ECG lead.The waveform corresponding to the selected lead button will be displayed.Input Overload/Dynamic RangeThe ViSi Mobile Monitor display indicates an input overload condition (i.e. the input dynamic range of theamplifier associated with the displayed ECG lead has been exceeded) by displaying the trace in red at thetop (or bottom) of the ECG waveform display area.Note: When an input overload / dynamic range issue occurs, check the lead fail status.Amplifier is over-loaded due to anthe positive limit ofthe dynamic rangeinput that exceedson a continuousbasisPositive limit ofthe dynamic rangeonly at the peaksof the QRSis being exceededcomplex of theECG waveformDynamic range of theECG amplifier has notpeaks of the QRScomplex of the ECGbeen exceeded. Thewaveform extendbeyond the upper edgeof the display area.

Patient Reports676.5 Patient ReportsNote: The use of a thermal printer is not recommended.6.5.1 List TrendsTo Print the List Trends Report1. Navigate to the List Trends view (or instructions, see Viewing List Trends on page 62).The List Trends view will be displayed in the Work Area.2. Touch or click the Print button.The list trends report will be printed.

Patient Reports 686.5.2 WaveformsTo Print the Waveform Report1. Navigate to the Current Waveforms view (or instructions, see Viewing Current Waveforms on page65).The Current Waveforms view will be displayed in the Work Area.2. Touch or click the Print button.The waveforms report will be printed.

697. Alarms7.1 IntroductionThe ViSi Mobile Monitoring System provides a comprehensive alarm system that alarms on changes to thepatient’s physiologic status (alarms) and technical alarms (alerts). The system provides default alarm limits for physiological alarms. The clinician can manually change thealarm limits for each patient to provide individualized care.Note: Changes made to the alarm limits from the ViSi Mobile Remote Viewer do not come intoeffect until the ViSi Mobile Monitor has received the change request.Technical alarms (alerts) are provided to notify the clinician of situations that may impede the ability tomonitor your patient.7.1.1 System Alarm ManagementDuring the installation of the ViSi Mobile Monitoring System, alarm configurations may be modified toconform to the alarm policies set by the clinical care unit. General Alarm Management RulesThe following general alarm management rules pertain to the ViSi Mobile Monitoring System:• All ViSi Mobile Monitoring System alarms conform to IEC 60601-1-8.• Alarms and alerts originate from the ViSi Mobile Monitor (worn by the patient).• Silencing/acknowledging a patient’s alarm or alert suspends the audio tones for up to 2 minutes.When a new alarm/alert occurs during the 2 minute silenced/acknowledged period, the new alarm/alert will be immediately annunciated.Note: When the clinician silences/acknowledges an alarm/alert, all active alarms/alerts in progresswill also be silenced/acknowledged for the 2 minutes. The clinician does not need to silence/acknowledge each alarm/alert individually.• Alarm annunciation may be turned off for an indefinite period of time. This disables theannunciation of alarms and alerts on both the ViSi Mobile Monitor and the Remote Viewer for the“off” duration. Turning the alarms off must be done directly from the ViSi Mobile Monitor (wornby the patient), however, alarms may be turned back on from either the ViSi Mobile Monitor or theRemote Viewer.• Alarm annunciation may be paused for 2 minutes. This disables the annunciation of alarms andalerts on both the ViSi Mobile Monitor (worn by the patient) and the Remote Viewer for thepaused duration. Pausing the alarms must be done directly from the ViSi Mobile Monitor (worn by

Introduction 70the patient), however, alarms may be resumed from either the ViSi Mobile Monitor or the RemoteViewer.Note: When the annunciation of alarms/alerts has been turned off or paused, certain importantalarms and alerts will continue to annunciate (known as break-through alarms and alerts).These are generally equipment alerts that inhibit the ability to monitor the patientappropriately.Note: When alarms/alerts are paused, alarms/alerts currently in progress will no longer beannunciated. The annunciation of any new alarms/alerts will be disabled for the 2 minuteduration.Note: When alarms/alerts are silenced/acknowledged, the audio tone will be silenced. Any newalarms/alerts occurring during the 2 minute silenced/acknowledged duration will beimmediately annunciated.In Network RulesWhen the ViSi Mobile Monitor is in network and connected to the ViSi Mobile Remote Viewer:• When the ViSi Mobile Monitor is connected to the Remote Viewer, the audio alarm and alert toneswill be deferred from the Monitor to the Remote Viewer, for a pre-configured length of time.Note: Audio tones for life threatening alarms will not be delayed.• Alarms/alerts may be silenced/acknowledged from either the ViSi Mobile Monitor or RemoteViewer.Note: Silencing/acknowledging a life threatening alarm directly from the ViSi Mobile RemoteViewer will only silence/acknowledge the alarm on the Remote Viewer. To silence/acknowledge the life threatening alarm on the ViSi Mobile Monitor, the clinician mustsilence/acknowledge the alarm directly from the Mobile Monitor (worn by the patient).• When alarm annunciation has been turned off, alarm annunciation may be turned back on fromeither the ViSi Mobile Monitor or Remote Viewer. Turning alarm annunciation off can only bedone directly from the ViSi Mobile Monitor (worn by the patient).• When alarm annunciation has been temporarily paused, alarm annunciation may be resumed fromeither the ViSi Mobile Monitor or Remote Viewer. Pausing alarm annunciation can only be donedirectly from the ViSi Mobile Monitor (worn by the patient).

Physiological Alarms (Alarms) / Technical Alarms 717.2 Physiological Alarms (Alarms) / Technical Alarms (Alerts) Summary7.2.1 Responding to Alarms/AlertsSilencing Audible Alarms/Alerts from ViSi Mobile Remote ViewerPriority Type of Alarm Silence ButtonWhere to Respond to AlarmAudio TonesRemote Viewer(At Clinician’s Station) Mobile Monitor(At Patient)1 Silence at Remote Viewer or Mobile Monitor.(2 minute audible silenced on both Remote Viewer and Mobile Monitor.)BeepBeepBeep- Pause -BeepBeep2 Silence at Remote Viewer or Mobile Monitor.(2 minute audible silenced on both Remote Viewer and Mobile Monitor.)BeepBeepBeep- Pause -BeepBeep3 Silence at Remote Viewer or Mobile Monitor.(2 minute audible silenced on both Remote Viewer and Mobile Monitor.)BeepBeep- Pause -4 Visual Only - No SoundAcknowledge at the Remote Viewer or Mobile Monitor.(Acknowledged for 2 minutes at both the Remote Viewer and Mobile Monitor.)No audio tones.Life ThreateningHigh(High)Alerts(Low)Alerts

Physiological Alarms (Alarms) / Technical Alarms (Alerts) Summary 727.2.2 Managing Alarm/Alert AnnunciationsAnnunciation: Refers to the audible and visual display of alarms/alerts.Note: When multiple alarms and alerts occur simultaneously, the message text will only displaymessages associated with the highest alarm severity. The vital measurements will display allexisting alarms, regardless of their severity.Action Action Button Duration Allow Where EffectsPause Alarms/AlertsN/A 2 Minutes May only be paused from the ViSi Mobile Monitor.Annunciation disabled at both the ViSi Monitor and Remote Viewer.Resume Alarms/AlertsN/A ViSi Mobile Monitor and Remote Viewer.Annunciation resumed at both the ViSi Mobile Monitor and Remote Viewer.Turn Alarms/Alerts OffN/A Indefinitely May only be turned off from the ViSi Mobile Monitor.Annunciation disabled at both the ViSi Monitor and Remote Viewer.Turn Alarms/Alerts OnN/A ViSi Mobile Monitor and Remote Viewer.Annunciation turned on at both the ViSi Mobile Monitor and Remote Viewer.

Responding to Physiological Alarms (Alarms)737.3 Responding to Physiological Alarms (Alarms)7.3.1 To Silence/Acknowledge Life Threatening Severity AlarmsLife threatening severity alarms require urgent clinician response.To silence/acknowledge the alarm, touch the Silence/Acknowledge Alarm button. The alarm is silenced/acknowledged and the “Silenced/Acknowledged” symbol and countdownwill be displayed. After the 2 minute countdown has expired, the alarm will be re-annunciatedSymbol Annunciation Color Audio Tone Duration (ms) Spacing (ms)White / Red BBB P BB P BBB P BB...B - Beep / P - Pause100 50Silence/AcknowledgeAlarmDetail ViewSummary View

Responding to Physiological Alarms (Alarms) 74Silenced/Acknowledgedsymbol and countdownDetail ViewSummary View

Responding to Physiological Alarms (Alarms)757.3.2 To Silence High Severity AlarmsHigh severity alarms require immediate clinician response at the bedside.To silence/acknowledge a high alarm, touch the Silence/Acknowledge Alarm button. The alarm is silenced/acknowledged and the silenced/acknowledged symbol and countdown willbe displayed.Symbol Annunciation Color Audio Tone Duration (ms) Spacing (ms)Red BBB P BB P BBB P BB...B - Beep / P - Pause200 100Silence/AcknowledgeAlarmDetail ViewSummary View

Responding to Physiological Alarms (Alarms) 76Note: When a high alarm occurs and the alarming condition resolves itself before a clinician is ableto respond, the high alarm message will be displayed (in gray) for up to 5 minutes in themessage area. This serves as a reminder to the clinician that the high alarm has occurred.Silenced/Acknowledgedsymbol and countdownDetail ViewSummary View

Responding to Equipment Alarms (Alerts)777.4 Responding to Equipment Alarms (Alerts)7.4.1 To Silence/Acknowledge Alerts (All Severities)Equipment alerts are used when the ability to monitor the patient and detect a patient’s physiologicalalarms may be affected.Symbol Annunciation Color Severity Audio Tone Duration (ms) Spacing (ms)Cyan High B B PB - Beep / P - PauseThere will be a 15 second pause after each sequence.250 250Low No audio tones. N/A N/ASilence/AcknowledgeAlert

Responding to Equipment Alarms (Alerts) 78To silence/acknowledge an alert, touch the Silence/Acknowledge Alert button. The alert is silenced/acknowledged and the silenced/acknowledged symbol and countdown will bedisplayed.Note: When an alert condition (of any severity) resolves itself before a clinician is able to respond,the alert condition will no longer be annunciated.Silenced/Acknowledgedsymbol and countdown

Resume / Turn On Alarm Annunciation797.5 Resume / Turn On Alarm Annunciation7.5.1 To Resume Alarm Annunciation When alarms are paused, the annunciation of any existing and new alarm will be disabled at both the ViSiMobile Monitor and Remote Viewer. Alarms may be resumed from either Mobile Monitor or RemoteViewer.To resume alarm annunciation, touch the Resume button. Note: Alarm annunciation will resume at both the ViSi Mobile Monitor and Remote Viewer.Alarms are currently paused.Rii“P d”dti

Resume / Turn On Alarm Annunciation 807.5.2 To Turn On Alarm Annunciation When alarms are turned off, the annunciation of any existing and new alarm will be disabled at both theViSi Mobile Monitor and Remote Viewer. Alarms may be turned back on directly from the RemoteViewer.To turn the alarm annunciation back on, touch the Turn Alarms On button. Note: Alarm annunciation will be turned on at both the ViSi Mobile Monitor and Remote Viewer.Alarms arecurrently turned off.

Manage Alarm Limits817.6 Manage Alarm LimitsAlarm limits for the selected patient may adjusted individually or reset back to their factory default values.7.6.1 To change alarm limits individually1. Navigate to the patient’s Patient Home View.The Patient Home View for the selected patient will be displayed. The patient menu is locateddirectly below the patient’s vital signs.2. Touch/click the Alarm Settings option from the menu. The Alarm Settings menu will be displayed to the right of the selected Alarm Settings menu option.3. Touch/click the Change option from the Alarm Settings menu. Alarm limits for all sensors currently connected to the ViSi Mobile Monitor will be displayed.4. Touch/click the data entry box for the alarm limit to be changed.The cursor will now be placed into the selected alarm limit.5. Directly type in the new alarm limit using the keyboard.-or-Click/touch the up/down arrows to adjust the alarm limit. The new alarm limit will be displayed.6. Repeat steps 4 through 6 for all alarm limits to be changed.SaveAlarm SettingsChangeMenu OptionMenu Option

Manage Alarm Limits 827. Touch Save to save the new alarm limits. The new alarm limits will be communicated to the ViSi Mobile Monitor and will become activeimmediately. If the alarm limits are not communicated to the Monitor, a message will be displayedon the ViSi Mobile Remote Viewer.-or-Touch Cancel to return to close the current view. Any modifications to the alarm limits will be discarded.

Manage Alarm Limits837.6.2 To reset alarm limits to default values1. Navigate to the patient’s Patient Home View.The Patient Home View for the selected patient will be displayed. The patient menu is locateddirectly below the patient’s vital signs.2. Touch/click the Alarm Settings option from the menu. The Alarm Settings menu will be displayed to the right of the selected Alarm Settings menu option.3. Touch/click the Change option from the Alarm Settings menu. Alarm limits for all sensors currently connected to the ViSi Mobile Monitor will be displayed.4. Touch/click the Reset Patient Defaults button.The new alarm limit will be displayed.5. Touch Save to save the new alarm limits. The new alarm limits will be communicated to the ViSi Mobile Monitor and will become activeimmediately. If the alarm limits are not communicated to the Monitor, a message will be displayedon the ViSi Mobile Remote Viewer.-or-Touch Cancel to close the current view. Any modifications to the alarm limits will be discarded.SaveResetButton

ViSi Mobile Remote Viewer Audio Test 847.7 ViSi Mobile Remote Viewer Audio Test7.7.1 To test the ViSi Mobile Remote Viewer SpeakerTest the ViSi Mobile Remote Viewer speaker to determine if audio tones sound at the Remote Viewer andhow loud they are.Touch/click the Speaker Test button. An audio tone will start to play and the speaker icon on the Speaker Test button will animate. Click/touch the Speaker Test button to stop the speaker test.When testing the speaker at the ViSi Mobile Remote Viewer, if the tonedoes not sound or it is not loud enough check the speaker volume is turnedup. If the sound is still not sound loud enough, immediately contact abiomedical engineer. The test indicates how alarm and alert tones sound atthe Remote Viewer. If the volume is inadequate, clinicians could missalarms and alerts.Speaker TestButton

858. Pause / Stop Monitoring8.1 Pause MonitoringWhen monitoring is paused on the ViSi Mobile Monitor, the corresponding Patient Tile on the ViSi MobileRemote Viewer will display an acknowledged MONITORING PAUSED alert the time at whichmonitoring was paused. If monitoring of the patient is not going to be resumed, monitoring may bestopped by removing the patient from the Remote Viewer using the Remove Patient workflow, outlinedbelow.For information on how to Pause Monitoring on the ViSi Mobile Monitor, see the ViSi Mobile MonitorUser Manual.Note: It is not possible to stop monitoring directly from the ViSi Mobile Monitor after monitoringhas been paused.

Pause Monitoring 86Patients tiles with assigned locations Patients tiles with no assigned locationPatient Home View

Stop Monitoring878.2 Stop MonitoringWhen monitoring is stopped on the ViSi Mobile Monitor, the corresponding Patient Tile on the ViSiMobile Remote Viewer will display an acknowledged MONITORING STOPPED alert and the time atwhich monitoring was stopped. To remove the patient from the Remote Viewer and complete the “stop”process, follow the Remove Patient workflow, outlined below.For information on how to Stop Monitoring on the ViSi Mobile Monitor, see the ViSi Mobile Monitor UserManual.Patients tiles with assigned locations Patients tiles with no assigned locationPatient Home View

Removing Patients from the Care Unit 888.3 Removing Patients from the Care UnitRemove Patient will be enabled for the selected patient when one of the following has occurred:• Monitoring has been stopped• Monitoring has been paused• The patient’s monitor is not currently connected to the network.To remove the patient (and their information) from the ViSi Mobile Remote Viewer, use the “Remove”feature.8.3.1 To remove a patient from the Care Unit View1. If the patient is not already selected, select the patient from the Care Unit view. See “Work Area”on page 27.2. Touch or click the Edit / Remove Patient menu option. The second level menu associated with the Edit / Remove Patient menu will be displayed to theright of the Edit / Remove Patient menu.3. Touch or click the Remove Patient menu option.The Remove Patient view will be displayed.

Removing Patients from the Care Unit894. Touch or click Remove to remove the patient from the care unit.-or -Touch or click Cancel.If cancelled, the patient will continue to be displayed in the Care Unit Area.If the removal is confirmed, the patient will be removed from the Care Unit.After monitoring has been stopped on the ViSi Mobile Monitor, removing thepatient from the ViSi Mobile Remote Viewer cannot be undone. Onceremoved, the patient will no longer be available on the Remote Viewer.

Removing Patients from the Care Unit 90- Notes -

919. Care Unit Views9.1 Care Unit DevicesThe Care Unit Devices view allows the clinician to see all the ViSi Mobile Monitors currently in use bypatients. The screen provides a view of the battery state for each Monitor.To view the ViSi Mobile Monitors currently in useTouch or click on the Devices Tab in the System Menu.The Care Unit Devices view will be displayed in the Work Area.Note: Hovering the mouse over any of the Devices boxes will display the patient’s primary ID,secondary ID and their assigned location. See image above.

Care Unit Devices 92- Notes -

9310. Troubleshooting10.1 IntroductionThe ViSi Mobile Monitoring System is designed to alert the clinician to technical issues that may occurwhile monitoring a patient’s vital signs.The following tables provide troubleshooting solutions to potential problems that may be encounteredwhile monitoring a patient.10.1.1 Customer SupportToll-Free: +1-866-232-6126International: +1-858-427-4620Fax: +1-858-427-4639E-mail: support@soterawireless.com

ViSi Mobile Monitor 9410.2 ViSi Mobile Monitor10.2.1 Screen AccessProblem Potential Cause SolutionThe screen is blank The display is in Quiet Monitoring Mode.Touch the screen with one finger for two seconds to activate display.Plug in a sensor to initiate monitoring.The display is in Hibernation Mode.Plug in a sensor to initiate monitoring.The battery charge is too low. Disconnect all sensors from the Monitor, clean the Monitor, and place it in the Charger.Sensors won’t plug into the MonitorPlug is oriented with the connector contacts facing downwards.Orient the Plug so that the connector contacts are facing upwards.Trying to Plug into wrong end of the Monitor.Only the Thumb Sensor is designed to be Plugged into the rounded end of the Monitor. All other sensors can be Plugged into any port on the flat end of the Monitor.Monitor is not seated in the cradle correctly.Ensure the Monitor is pushed all the way into the cradle and secure with either the Thumb Sensor or Locking Plug.Problem Potential Cause SolutionNo response to touching any buttonsTouching the screen with more than one finger.Touch the button with only a single finger.Button is not an active button. Active buttons are those with borders, and are not dimmed in appearance compared to other buttons.Touching the screen with a pen or stylus.Note: May cause damageto the touch screen.Touch the button with only a single finger.Cannot access the Vital Signs screenScreen is locked. Touch the Unlock button and enter the correct PIN.Access denied due to entering the wrong PIN code.Enter the correct PIN code.

ViSi Mobile Chest Sensor Cable9510.3 ViSi Mobile Chest Sensor CablePatient has accessed the monitoring functionsScreen was not locked after last clinician interaction.• Once all interactions are complete, make sure to lock the screen.• Remind the patient that this is a med-ical device, and that tampering may result in missing important clinical events.Patient guessed PIN correctly. • Define appropriate PIN codes (not 0000 for example).• Remind the patient that this is a med-ical device, and that tampering may result in missing important clinical events.Problem Potential Cause SolutionChest Sensor Cable is too short to plug into the MonitorMonitor is oriented in the wrong direction.Make sure that the flat end of the Monitor is oriented towards the elbow.The Chest Sensor Cable is secured to the side of the chest opposite the arm with the Monitor.Secure the Chest Sensor Cable midway between the sternum and the shoulder of the same arm that the Monitor is on.The Chest Sensor Module has been put on upside down.Rotate the Chest Sensor Module 180o such that the analog cable is facing upwards from the top of the Chest Sensor Module and the digital cables are facing downwards.No HR numeric ECG electrodes not connected to lead-wires.Ensure that the lead-wires are snapped securely onto the ECG electrodes.ECG electrodes not firmly attached to the patient’s chest.Ensure that the ECG electrodes are securely attached to the chest; ECG electrode sites are clean and free of excess hair.ECG electrode gel is dry. Replace ECG electrodes.Broken/damaged lead-wires. Replace damaged Chest Sensor Cable.Chest Sensor Cable not securely Plugged into the Monitor.Make sure that the Chest Sensor Cable is securely Plugged into the Monitor.HR displays “XX” A lead-wire or sensor problem is affecting the measurement.If the problem persists, replace the ECG electrodes and/or Chest Sensor Cable.Problem Potential Cause Solution

ViSi Mobile Chest Sensor Cable 96HR is erratic ECG electrodes are not all the same.Use all the same ECG electrode type, size, materials, and manufacturer.ECG electrode gel is dry. Replace ECG electrodes.ECG electrodes not firmly attached to the patient’s chest.Check the ECG electrodes are securely attached to the chest; ECG electrode sites are clean and free of excess hair.Skin is not prepared correctly. See instructions for skin preparation.No ECG waveform See No HR numeric above. See No HR numeric above.ECG waveform too small Using a 3-lead Chest Sensor Cable: Lead II has a low amplitude.Lead II only available with a 3-lead Chest Sensor Cable.• Select alternate ECG electrode sites; prepare skin sites; connect lead-wires to new ECG electrodes and place on the chest.• Replace 3-lead Chest Sensor Cable with 5-lead Chest Sensor Cable.Using a 5-lead Chest Sensor Cable: Selected lead has low amplitude.5-lead Chest Sensor Cable: select a different lead to view.ECG waveform is noisy; looks like pacer indicators in the waveformECG electrodes not firmly attached to the patient’s chest.Ensure that the ECG electrodes are securely attached to the chest; ECG electrode sites are clean and free of excess hair.ECG electrode gel is dry. Replace ECG electrodes.Skin is not prepared correctly. See instructions for skin preparation.No RESP numeric See No HR numeric above. See No HR numeric above.The Monitor is not capable of measuring RESP.Contact your biomedical engineer.RESP displays “XX” A lead-wire or sensor problem is affecting the measurement.If the problem persists, replace the ECG electrodes and/or Chest Sensor Cable.RESP is erratic ECG electrodes not firmly attached to the patient’s chest.Ensure that the ECG electrodes are securely attached to the chest; ECG electrode sites are clean and free of excess hair.ECG electrode gel is dry. Replace ECG electrodes.Problem Potential Cause Solution

ViSi Mobile Chest Sensor Cable97No SKIN temperature numeric The Chest Module sensor is placed on the patient with the Temperature Sensor facing away from the patient.Place the Chest Module sensor on the patient such that the Temperature Sensor is in direct contact with the patient’s chest.Sensor is not attached to the patient’s chest.Secure the Chest Sensor Cable to the chest. Make sure that a change in position does not affect the sensor’s contact with the skin.SKIN temperature displays “XX”The Temperature Sensor may have failed.If the problem persists, replace the Chest Sensor Cable.SKIN temperature is erratic Chest Sensor Cable is not in contact with the skin completely/securely.Secure the Chest Sensor Cable to the chest. Make sure that a change in position does not affect the sensor’s contact with the skin.Skin is not clean and dry. Clean and dry the skin thoroughly and secure the Chest Sensor Cable to the chest.Problem Potential Cause Solution

ViSi Mobile Thumb Sensor 9810.4 ViSi Mobile Thumb SensorProblem Potential Cause SolutionSensor cable too short to Plug into MonitorMonitor is oriented in the wrong direction.Make sure that the rounded end of the Monitor is oriented towards the hand.Thumb sensor is routed wrong. Make sure the cable is routed around the outside of the thumb.No SpO2 numeric Broken/damaged Thumb Sensor. Replace the Thumb SensorSomething is blocking the optics or detector in the Thumb Sensor.Make sure nothing is blocking the optics or detector.Thumb Sensor not secured in the Thumb Sensor Cradle.Place the Thumb Sensor securely in the Thumb Sensor cradle.Thumb Sensor not secured to the base of the thumb.Secure the Thumb Sensor to the base of the thumb.Thumb Sensor not securely Plugged into the Monitor.Make sure that the Thumb Sensor is securely Plugged into the Monitor.SpO2 displays “XX” A sensor problem is affecting the measurement.If the problem persists, replace the Thumb Sensor.SpO2 is erratic Something is partially blocking the optics or detector in the Thumb Sensor.Make sure nothing is blocking the optics or detector.Thumb Sensor not secured to the base of the thumb.Secure the Thumb Sensor to the base of the thumb.Thumb Sensor is not in the correct location.Reorient the Thumb Sensor at the base of the thumb and secure with the Thumb Wrap.Thumb Strap is too tight. Loosen the Thumb Strap making sure that it is still secure.

ViSi Mobile Cuff Module9910.5 ViSi Mobile Cuff ModuleProblem Potential Cause SolutionCuff Module cable is too short to Plug into MonitorMonitor is oriented in the wrong direction.Make sure that the flat end of the Monitor is oriented towards the arm.Cuff Module is on the arm opposite the Monitor.Place the Cuff Module on the same arm that the Monitor is on.No NIBP measurement Battery charge is too low. Replace the Cuff Module.Cuff Module not Plugged securely into the Monitor.Make sure that the Cuff Module is Plugged securely into the Monitor.Not set up for automatic measurements.From the NIBP Settings screen, select an automatic interval.The time from the last measurement exceeds the period of time to display a measurement.Initiate a measurement from the Vital Signs screen.Disposable Cuff was touched during inflation.Avoid touching the ViSi Mobile Disposable Cuff during inflation as this may disrupt the measurement.Disposable Cuff not placed correctly.Ensure Disposable Cuff is placed onto the patient’s arm correctly. Line up the arterial line as indicated on the Disposable Cuff.NIBP measurement doesn’t match an auscultatory measurementMeasurements were not taken at the same time.Measurements are taken at the same time.Measurements were taken on different arms.The BP in both arms is the same, sometimes there is a difference between arms.Different size cuffs were used. Ensure the BP cuff size is the same on both arms, and the correct size for the arm.Both arms were not at the same level when the BP was measured.The arms are positioned at the same level relative to the heart.Disposable cuff was touched during inflation.Avoid touching the ViSi Mobile Disposable Cuff during inflation as this may disrupt the measurement.

ViSi Mobile Cuff Module 100Blood pressure mode set to continuous NIBP but only one NIBP measurement taken.The patient’s PATis not stable. Ensure the patient is still before calibration is started and remains still during the calibration process.Note: When the patient’s PAT isstable, the “c” on theCalibrate cNIBP button willbe displayed in red. WhenPAT is not stable, the “c”will be displayed in gray.LED on Cuff Module displays red when in the Charger.Voltage level has exceeded expectation.• Remove Cuff Module from the Char-ger.• Report the problem to Sotera Wire-less Inc. Customer Service Depart-ment or the Sotera Wireless representative in your area.Current level has exceeded expectation.• Remove Cuff Module from the Char-ger.• Report the problem to Sotera Wire-less Inc. Customer Service Depart-ment or the Sotera Wireless representative in your area.Over temperature protection current temperature has exceeded expectation.• Remove Cuff Module from the Char-ger.• Report the problem to Sotera Wire-less Inc. Customer Service Depart-ment or the Sotera Wireless representative in your area.Problem Potential Cause Solution

ViSi Mobile Battery Charger10110.6 ViSi Mobile Battery ChargerProblem Potential Cause SolutionBatteries in the Monitor and Cuff Module do not chargeThe Monitor and Cuff Module are not securely seated in the Charger.Make sure that the Monitor and Cuff Module are securely seated in the Charger.The monitor and Cuff Module are designed to fit into the Charger in one direction.The Charger is not completely Plugged in to the wall socket.• Make sure that the Plug is securely Plugged into an active wall socket and there is a green light on the Bat-tery Charger.• Make sure that the power cord is not damaged.AC Adapter is not Plugged into the Charger.• Plug the AC Adaptor into the Char-ger.The Monitor and/or Cuff Module were insterted into the Charger without being thoroughly dried (after cleaning/disinfecting).• Dry equipment thoroughly before placing in the Charger.

General Troubleshooting 10210.7 General Troubleshooting10.7.1 Connectivity Lost10.7.2 Alarms and AlertsProblem Potential Cause SolutionOn the ViSi Mobile Remote Viewer, “XX” appears where all vital sign measurements should be displayed.The patient wearing the ViSi Mobile Monitor has moved outside of the wireless network area.Move the patient back into the wireless network area.On the ViSi Mobile Remote Viewer, all patients have disappeared from the Care Unit Area.The network cable has been disconnected from the ViSi Mobile Remote Viewer.Reconnect the network cable to the Remote Viewer.When testing the speaker at the ViSi Mobile Remote Viewer, if the tonedoes not sound or it is not loud enough check the speaker volume is turnedup. If the sound is still not sound loud enough, immediately contact abiomedical engineer. The test indicates how alarm and alert tones sound atthe Remote Viewer. If the volume is inadequate, clinicians could missalarms and alerts.Problem ExplanationI acknowledge an alarm at the ViSi Mobile Remote Viewer, but the audio tone still occurs at the ViSi Mobile Monitor.• Life-Threatening alarms latch at the ViSi Mobile Monitor until they are acknowledged there, even if the alarm condition resolves. • Certain alerts (such as a sensor being discon-nected) continue to annunciate at the ViSi Mobile Monitor until the alert is acknowledged at the Monitor.An alarm occurs, but the audio tone stops before I acknowledge it.• If an alarm or alert condition resolves before it is acknowledged, the audio tones stops.• If the alarm condition was a high-level severity, the alarm message will remain visible (in gray) for five minutes.I stop monitoring a patient at the ViSi Mobile Monitor, according to procedure, but a MONITOR STOPPED alert still appears on the ViSi Mobile Remote Viewer.The alert informs all clinicians who are remotely monitoring the patient that monitoring has stopped.Acknowledge the alert to remove the patient from the care unit.My patient had a vital sign alarm. I did not acknowledge the alarm, but I removed the sensor from the patient. The vital sign alarm continued.The vital sign alarm must be acknowledged, even if the sensor is removed.

General Troubleshooting103An alert with the icon and PATIENT TAMPERING message occurred. What does it mean?Someone has unsuccessfully tried to log in to the ViSi Mobile Monitor five or more times.The visual indications go away after the alert is acknowledged and after a clinician successfully logs in at the Monitor.When an alarm or alert occurs, the audio annunciation is heard on the ViSi Mobile Remote Viewer, but there is no audio on the ViSi Mobile Monitor.Most alarms and alerts will audibly annunciate at the ViSi Mobile Remote Viewer before they audibly annunciate at the ViSi Mobile Monitor.This is to minimize disturbing the patient.Sometimes if more than one alarm or alert occurs for a patient at the same time, one or more of the messages don’t show.• If the alarms or alerts are the same severity level, the messages will cycle through.• Messages for alarms or alerts that are at a lower severity level will not be displayed.• If alarms and alerts occur simultaneously, only messages associated with the alarms will be dis-played.• Other visual indications usually show for lower level alarms and alerts.Sometimes I acknowledge an alarm or alert, and all alarm or alert indications go away. The audio tone never returns.Some alarms and alerts are acknowledged permanently.At the ViSi Mobile Monitor, I set all alarming to OFF, or I set all alarming to PAUSED. But some alarms and alerts continue to be annunciated.Some important alarms and alerts (such as sensor being disconnected) will continue to annunciate even when all alarms are turned off, or paused.When an alarm or alert occurs, the ViSi Mobile Remote Viewer does not sound an audio tone, or the tone is not loud enough.• Some alerts do not have an audio tone. When an audio tone is associated with an alarm or alert, the Speaker Test button will animate.• When an audio tone is expected, but not present (or not loud enough), immediately contact your biomedical engineer.• The speaker volume for the ViSi Mobile Remote Viewer can be tested at any time.The ViSi Mobile Remote Viewer displays a CONNECTIVITY LOST alert, what does it mean? The ViSi Mobile Monitor is no currently connected to the network.Problem Explanation

ViSi Mobile Remote Viewer 10410.8 ViSi Mobile Remote Viewer10.8.1 Setting Alarm LimitsProblem ExplanationWhen I try to adjust individual limits in the Alarm Settings pane, I cannot go past certain limit values.Patient alarm limits may not be set beyond the care unit alarm limits.When I adjust an upper limit, the lower limit also changes, or vice versa.When a vital sign limit is adjusted to equal the opposite limit, the opposite limit adjusts. Upper and lower limits for a vital sign cannot be the same value.The alarm limits on the ViSi Mobile Monitor and the limits at the ViSi Mobile Remote Viewer do not match.The alarm limits were set on the ViSi Mobile Monitor while the Monitor was not connected to the network. The new limits will not be communicated back to the ViSi Mobile Remote Viewer until the Monitor reconnects to the network.The alarms were changed on the ViSi Mobile Remote Viewer but before the new alarm limits were communicated to the ViSi Mobile Monitor, the Monitor moved out of network.The limits on the Monitor are the operating limits at all times.

10511. Specifications11.1 IntroductionThis section provides specifications regarding measurement ranges, accuracy levels and environmentaloperating conditions for the ViSi Mobile Monitoring System.Do not use the ViSi Mobile Monitoring System in neonatal or pediatricpatients under the age of 18 years since the System has not been tested forthese patient groups.

Vital Sign Measurements 10611.2 Vital Sign Measurements11.2.1 Heart RateHeart RateDisplay Range 0 to 240 BPMAccuracy Range 30 to 240 BPMAccuracy ±3 BPMResolution 1 BPMPacemaker • The monitor detects and rejects pacemaker impulses in accordance with AAMI EC13:2002• Performs heart rate calculations on a patient with a pacemaker• Will not recognize a pacemaker impulse as a QRS• Displays pacer markers on ECG waveformsPacemaker Pulse Rejection Without OvershootTested per EC13:2002, 4.1.4.1:Pulse Rejection Range: Amplitude from ±2 mV to ±700 mVPulse Width from 0.1 ms to 2 msNote: Amplitude limited to 660mV for pulse widths from 1.5 to 2.0msNote: Pulses with polarization overshoot > 25mS may cause R-Wave detection.Indicated Heart Rate:Ventricular Pacing: Case (a): 0 BPMCase (b): 60 BPMCase (c): 30 BPMAtrial / Ventricular Pacing: Case (a): 0 BPMCase (b): 60 BPMCase (c): 30 BPM

Vital Sign Measurements107Pacemaker Pulse Rejection With OvershootTested per EC13:2002, 4.1.4.2, Method A:Pulse Rejection Range: Amplitude from ±2 mV to ±700 mVPulse Width from 0.1 ms to 2 msNote: Amplitude limited to 660mV for pulse widths from 1.5 to 2.0msNote: For pulse width > 1.0mS, recovery time limited to 25mS.Indicated Heart Rate:Ventricular Pacing: Case (a): 0 BPMCase (b): 60 BPMCase (c): 30 BPMAtrial / Ventricular Pacing: Case (a): 0 BPMCase (b): 60 BPMCase (c): 30 BPMPacer Pulse Detector Rejection of Fast ECG SignalsTested per EC13:2002, 4.1.4.3:• Minimum Slew Rate: 25 V/sDefibrillation Response • Defibrillator protected• Displays HR measurement < 30 seconds after a defibrillation event• Displays an ECG waveform < 10 seconds after a defibrillation eventNote: Defibrillation events may be implanted or external.Note: Defibrillation recovery is dependent upon using proper disposable electrodes. Use only Ag-AgCl disposable electrodes.T-Wave Rejection Tested per EC13:2002, 5.1.2.1:• T-waves up to 1.2 mV in amplitude:• T-waves not detected, no change in indicated heart rate.Heart Rate Averaging Tested per EC13:2002, 5.1.2.1 d): • 20 second moving averageHeart Rate Accuracy and Response to Irregular RhythmTested per EC13:2002, 5.1.2.1 e):• Waveform 3a: 80 BPM• Waveform 3b: 48 BPM• Waveform 3c: 90 BPM• Waveform 3d: 90 BPMChange in Heart Rate Tested per EC13:2002, 5.1.2.1 f):• 80 BPM to 120 BPM: < 13 seconds• 80 BPM to 40 BPM: < 13 secondsTime to Alarm for Cardiac StandstillTested per EC13:2002, 4.2.8.4:• < 10 secondsHeart Rate

Vital Sign Measurements 108Time to Alarm for TachycardiaTested per EC13:2002, 5.1.2.1 g):Figure 4a:• Gain = 1.0x: 5 seconds• Gain = 2.0x: 5 seconds• Gain = 0.5x: 9 secondsFigure 4b:• Gain = 1.0x: 6 seconds• Gain = 2.0x: 6 seconds• Gain = 0.5x: 7 secondsInput Impedance > 20 MohmsFrequency Response 0.5 to 125HzLead Off Detection Current < 24 nACommon Mode Rejection Ratio> 85 dBHeart Rate

Vital Sign Measurements10911.2.2 RespirationRespirationMethod Impedance PneumographyDisplay Range 0 to 50 BR/MINAccuracy Range 3 to 50 BR/MINAccuracy ± 3 BR/MIN or 10% of reading, whichever is greaterResolution 1 BR/MINRespiration Drive Voltage: 1.00 V P-P ±5%Frequency: 32.0 KHz ±2%

Vital Sign Measurements 11011.2.3 Pulse Oximetry (SpO2, Functional Oxygen Saturation)Pulse Oximetry (SpO2, Functional Oxygen Saturation)Normative Reference ISO 9919: 2005SpO2Display Range 49 to 100%Accuracy Range 70 to 100%Accuracy ≤ 2% from 70-100% (no motion)aUnspecified from 49-69%a. Bench testing indicates accuracy may be compromised at pulse rates below 50BPM at modulations less than 0.6% and extremely low pulse rates of 30BPM at modulations less than 0.8%.Resolution 1%Pulse Rate Display Range 0 to 240 BPMAccuracy Range 30 to 240 BPMAccuracy(No Motion)± 3 BPM; < 50 BPM @ ≥ 0.6% Pulsatile Modulation± 3 BPM; ≥ 50 BPM @ ≥ 0.4% Pulsatile ModulationAccuracy (RMS Error) ≤ 3 BPMRate Resolution 1 BPMValidation Study Per ISO 9919. The ViSi SpO2 is calibrated to display functional oxygen saturation and validated against human subjects arterial blood sample reference measured with CO-Oximeter (see Bland-Altman: ViSi Mobile Pulse Oximetry table).Note: A functional tester cannot be used to assess the accuracy of apulse oximeter probe or a pulse oximeter monitor.Calculation Rate Every pulseDisplay Refresh Rate Every 3 secondsAveraging 12 beat average following initializationAlarm Range Low - Fixed at 85%Alarm Delay 30 seconds (fixed)Waveform Display • Amplitude is normalized• Sweep speed is scaled to 25mm/sec to match ECGSensor Application Time Sensor should be checked every 8 hoursOptical Wavelengths / powerRed: 660nm / max 6.5mW (±15%)Infra-Red: 905nm / max 5.2mW (±15%)Interference SpO2 can be adversely effected by the presence of dyshaemoglobins, ambient light (including photosynamic therapy); electromagnetic interference; electrosurgical units; dysfunctional hemoglobin; presence of certain dyes; inappropriate positioning of the pulse oximeter probe.Toxicity Thumb sensor uses white silicone which has no known toxicity effects.

Vital Sign Measurements111The table below shows Arms values measured using the ViSi Mobile Thumb Sensor (Model 92-10020) withthe ViSi Mobile Monitoring System in a clinical study:Validation Data (per ISO 9919)Age of Volunteers 18 - 45SpO2 Accuracy (No Motion)SpO2 Range 70-100% 90-100% 80-90% 70-80%Accuracy (Arms) - No Motion 1.9 1.2 1.9 2.4Bland-Altman: ViSi Mobile Pulse Oximetry

Vital Sign Measurements 11211.2.4 Non-Invasive Blood Pressure (NIBP)Non-Invasive Blood Pressure (NIBP)Normative Reference ISO 81060-2: Non-invasive Sphygmomanometers - Part 2: Clinical validation of automated measurement type.Principle of Operation OscillometrySystolic Range: 60 to 240 mmHgAccuracy: Mean error of less than ± 5 mmHg and a std. dev. of ≤ 8 mmHgResolution: 1 mmHgDiastolic Range: 40 to 160 mmHgAccuracy: Mean error of less than ± 5 mmHg and a std. dev. of ≤ 8 mmHgResolution: 1 mmHgMean Arterial Pressure Range: 50 to 185 mmHgAccuracy: Mean error of less than ±5 mmHg and a std. dev. of ≤ 8 mmHgResolution: 1 mmHgPulse Rate Accuracy (NIBP) <3 BPMValidation Study Invasive blood pressure (radial artery) referenceNumber of subjects: 16Subject Age Range: 19-48Sample Size: 152 data pointsMean: -1.65 mmHgStandard Deviation: 5.01 mmHgUpper 95% Limits of Agreement (+1.96 SD): 8.2 mmHgLower 95% Limits of Agreement (-1.96 SD): -11.5 mmHgSystolic Bland Altman Analysis (NIBP)

Vital Sign Measurements113Sample Size: 152 data pointsMean: -1.49 mmHgStandard Deviation: 3.22 mmHgUpper 95% Limits of Agreement (+1.96 SD): 4.8 mmHgLower 95% Limits of Agreement (-1.96 SD): -7.8 mmHgSample Size: 152 data pointsMean: -0.91 mmHgStandard Deviation: 2.04 mmHgUpper 95% Limits of Agreement (+1.96 SD): 3.1 mmHgLower 95% Limits of Agreement (-1.96 SD): -4.9 mmHgDiastolic Bland Altman Analysis (NIBP)Mean Arterial Pressure Bland Altman Analysis (NIBP)

Vital Sign Measurements 11411.2.5 Continuous Non-Invasive Blood Pressure (cNIBP)cNIBP Clinical Study ResultsSotera ViSi cNIBP vs. Reference Invasive Radial Artery Transducer (n=15 subjects)Continuous Non-Invasive Blood Pressure (cNIBP)Normative Reference ISO 81060-2: Non-invasive Sphygmomanometers - Part 2: Clinical validation of automated measurement type.Principle of Operation cNIBP is based on the relationship between blood pressure and the time it takes a pulse that originates from a cardiac contraction to arrive at a peripheral location.Display Update Continuous blood pressure is displayed based on averaging PAT calculations from the previous 60 seconds and updating the display every 3 seconds.Systolic Range: 60 to 240 mmHgAccuracya,b:a. ViSi Mobile Monitoring System accuracy claim is not met when the subject is inclined more than 30 degrees from horizontal.b. The accuracy and precision of the cNIBP measurement met ISO 81060-2 requirements for the first 2.5 hours of testing.Mean error of ≤ ± 5 mmHg and a std.dev. of ≤ 8 mmHgResolution: 1 mmHgDiastolic Range: 40 to 160 mmHgAccuracya,b:Mean error of ≤ ± 5 mmHg and a std.dev. of ≤ 8 mmHgResolution: 1 mmHgMean Arterial Pressure (MAP)Range: 50 to 185 mmHgAccuracya,b:Mean error of ≤ ± 5 mmHg and a std.dev. of ≤ 8 mmHgResolution: 1 mmHgValidation Study Invasive blood pressure (radial artery) referenceNumber of subjects: 15Subject age range: 19-48 yearsArm circumference range tested: 21-38 cmSubject Position Supine 30o60oOverallSystolic Bias -1.61 -4.77 -7.36 -1.88Std. Dev. 5.69 7.87 9.97 6.17Diastolic Bias -1.33 -3.97 -8.31 -1.65Std. Dev. 3.16 4.49 6.07 3.62MAP Bias -0.33 -3.01 -7.23 -0.67Std. Dev. 3.36 5.37 6.67 3.86Data Points 47,572 1,774 1,724 54,179

Vital Sign Measurements115Changes in posture can affect ViSi cNIBP accuracy. Recalibrate ViSi cNIBPwhenever torso changes by more than 30o above supine position. Sample Size: 54,179 data pointsMean: -1.88 mmHgStandard Deviation: 6.17 mmHgUpper 95% Limits of Agreement (+1.96 SD): 10.2 mmHgUpper 95% Limits of Agreement (-1.96 SD): -14.0 mmHgSample Size: 54,179 data pointsMean: -1.65 mmHgSystolic Bland Altman Analysis (cNIBP)Diastolic Bland Altman Analysis (cNIBP)

Vital Sign Measurements 116Standard Deviation: 3.62 mmHgUpper 95% Limits of Agreement (+1.96 SD): 5.4 mmHgUpper 95% Limits of Agreement (-1.96 SD): -8.7 mmHgSample Size: 54,179 data pointsMean: -0.67 mmHgStandard Deviation: 3.86 mmHgUpper 95% Limits of Agreement (+1.96 SD): 6.9 mmHgUpper 95% Limits of Agreement (-1.96 SD): -8.2 mmHgMAP Bland Altman Analysis

Vital Sign Measurements11711.2.6 Skin TemperatureTemperatureScale oCoFRange / Accuracy(measurement at approximately 102 kPa / 768 mmHg)Range Accuracy Range Accuracy0o - 19.9o±0.3o 32o - 67.9o±0.5o20o - 24.9o±0.3o68o - 76.9o±0.5o25o - 35.9o±0.2o77o - 96.7o±0.3o36o - 39.9o±0.1o96.8o - 103.9o±0.2o40o - 41.9o±0.2o104o - 107.5o±0.3o42o - 50.0o±0.3o107.6o - 122o±0.5oResolution ± 0.1o± 0.1oTransient Response < 6 min (25o - 37o) < 6 min (77o - 98.6o)

Physical Components 11811.3 Physical Components11.3.1 ViSi Mobile MonitorWireless Communications / RadioViSi Mobile MonitorPhysical Characteristics Dimensions 2.59 cm H x 4.85 cm W x 9.35 cm L 1.02 in. H x 1.91 in. W x 3.68 in. Lexclusive of connectors and Wrist CradleWeight 110 g / 3.92 ozMonitor Display OLED, 160 x 128 pixels, full colorAudio Alarm annunciation, QRS, self-testWaveforms One waveform, user selectableAspect Ratio: 0.4 Sec/mVScaled equivalent to 25 mm/sec sweep speedRespiration waveform scaled equivalent to 6.25 mm/sec sweep speedBattery Operating Time > 12 hoursFuel Charge Display Battery SymbolCharge Level with Full IndicationCharge Time Less than 4 hoursBattery Type Li-Ion, 3.7 V., 2000 mAh, single cellMaximum Temperature 45oC / 113oF Refer to IEC 60601-1:2005 (Section 11)Cleaning / Disinfecting Liquid Ingress Rating IPX7During cleaning cycle only, not during monitoringSolutions / Compounds • Isopropyl alcohol (IPA)• Detergent (Alconox)Wireless CommunicationsFrequency 2.402 - 2.480 GHzProtocol 802.11bModulation Direct Sequencing Spread SpectrumSecurity WPA2 / PSKPower Output (max) 8 mW (9 dBm)WiFi Alliance Compliant Yes; Reference Protocol: ASD 0478Data Throughput < 20 KBps

Physical Components119Mode PlugsIf you have any concerns regarding a cyber security breach or vulnerability, contactSotera Wireless or an authorized Sotera Wireless representative in your area.Mode PlugsShipping Plug Turns device off completelyBio Med Plugaa. The Bio Med Plug is not currently available.Enables configuration and test functionsLocking Plug Secures Monitor into Wrist Cradle

Physical Components 12011.3.2 ViSi Mobile Chest Sensor CableViSi Mobile Chest Sensor CableMechanical Complies with EC53Weight(5 lead-wire / 3 lead-wire)72 g / 62 g (2.54 oz. / 2.19 oz.)Maximum Temperature 43oC / 109.4oFRefer to IEC 60601-1:2005 (Section 11)Cleaning / Disinfecting Liquid Ingress Rating IPX7During cleaning cycle only, not during monitoringSolutions / Compounds • Isopropyl alcohol (IPA)• Detergent (Alconox)

Physical Components12111.3.3 ViSi Mobile Cuff ModuleViSi Mobile Cuff ModulePhysical Characteristics Dimensions 3.10 cm H x 4.85 cm W x 12.19 cm L(1.22 in. H x 1.91 in. W x 4.80 in. L)exclusive of cableWeight 157 g (5.54 oz)Battery Operating Time > 30 cuff inflations or 24 hrs, whichever occurs firstCharge Display Status Eight LEDs: Six levels of Green, Yellow, RedCharge Time < 4 hoursBattery Type Battery Pack, Li-Ion, 2000 mAhMaximum Temperature 45oC / 113oFRefer to IEC 60601-1:2005 (Section 11)Cuff SizesArm Circumference (cm)Small 20 – 26Medium 25 – 34Medium+ 25 – 34Large 32 – 43Large+ 32 – 43Cleaning / Disinfecting Liquid Ingress Rating IPX0Solutions / Compounds • Isopropyl alcohol (IPA)• Detergent (Alconox)When the ViSi Mobile Cuff Module is connected to the other ViSi MobileComponents, the entire system has an ingress protection rating of IPX0.

Physical Components 12211.3.4 ViSi Mobile Thumb SensorViSi Mobile Thumb SensorCleaning / Disinfecting Liquid Ingress Rating IPX7During cleaning cycle only, not during monitoringSolutions / Compounds • Isopropyl alcohol (IPA)• Detergent (Alconox)

Physical Components12311.3.5 ViSi Mobile Charger - 8 Bay11.3.6 ViSi Mobile Charger - 2 BayViSi Mobile ChargerPhysical Characteristics Dimensions 7.7 cm x 46.3 cm x 5.9 cm(3.0 in x 18.2 in x 2.3 in)Weight 0.7 kg (1.5 lb)AC Mains AC Line Voltage 100-240 V, 50-60 HzPower (all bays charging) 75 WCleaning / Disinfecting Liquid Ingress Rating IPX0Solutions / Compounds • Isopropyl alcohol (IPA)• Detergent (Alconox)ViSi Mobile ChargerPhysical Characteristics Dimensions 7.7 cm x 12.9 cm x 5.9 cm(3.0 in x 5.1 in x 2.3 in)Weight 0.25 kg (0.6 lb)AC Mains AC Line Voltage 100-240 V, 50-60 HzPower (all bays charging) 30 WCleaning / Disinfecting Liquid Ingress Rating IPX0Solutions / Compounds • Isopropyl alcohol (IPA)• Detergent (Alconox)

Physical Components 12411.3.7 ViSi Mobile ApplianceViSi Mobile ApplianceServer Configuration Single 1u, redundant hardware and internal RAID 10, dedicated hardware.Processor Single Intel Xeon 56202.4 GHz (or equivalent CPU)8 GB memoryStorage Server contains at a minimum 4 x 500 GB 7200 RPM hard drives in RAID 10 arrayOperating System Note: SUSE Linux Enterprise Server (Version 11, Patch Level 2)Network Requirements Static IP address or DHCP reservation requiredMulticast configuration on network backbone devicesDimensions(Single Appliance, may vary)H: 43.0 cm x W: 43.4 cm x L: 62.7 cm (w/o ear, w/o bezel)H: 1.7 in x W: 17.1 in x L: 24.7 inWeight(Single Appliance)35.02 lb (15.9 kg)(Maximum configuration weight)Power Requirements(Single Appliance)100-240 VAC, 50-60 Hz, 7 A - 3.5 A w/ redundant power supply Backup Power Requirement(Full System)Customer supplied Uninterruptable Power Supply and Hospital Emergency Power recommended.

Physical Components12511.3.8 ViSi Mobile Remote ViewerNote: Sotera Wireless recommends installation of Trend Micro anti-virus software on Windowsplatforms. Anti-virus software is not installed on the ViSi Mobile Appliance.Note: For printing capability, Sotera Wireless recommends connecting a printer directly to theViSi Mobile Remote Viewer or to an in-network printer via an IP address. Sotera Wirelessdoes not support additional configurations.ViSi Mobile Remote Viewer (Desktop PC with Touchscreen Display)No. of Patients per Remote Viewer Maximum 32Display 23 in display / 1920 x 1080 resolution(screen is touch sensitive to issue commands alternative to mouse/keyboard)Processor Intel i5 2400 CPU 4 Core3.10 GHz4 GB MemoryStorage One 500 GB 7200 RPM SATAOperating Systems Microsoft® Windows® 7 Professional (version 6.1) x64 Bit SP1Network Requirements Ethernet Connection, DHCPDimensions H: 45.0 cm x W: 58.5 cm x D: 10.3 cmH: 17.7 in x W: 23.0 in x D: 4.1 inWeight 26.7 lb (12.1 kg)Power Requirements AC/DC AdapterInput: 100-240 V ~3.5 A, 50-60 HzOutput to Viewer: 19.5 V / 11.8 ABackup Power Requirement Customer supplied Uninterruptable Power Supply and Hospital Emergency Power recommended.

Physical Components 12611.3.9 Customer NetworkWireless NetworkWireless Network Standard IEEE 802.11bRecommended Channels 1, 6, 11Network Latency < 150 msWireless Network Security Support WPA2-PSKMinimum Receiver Sensitivity -65 dBm (edge coverage)Wireless access point cell overlap 15-20%Signal-to-Noise Ratio ≥25 dBPacket loss ≤6%SSID Dedicated or shared with other medical devicesWired NetworkAppliance (Server) Requires static IP AddressNetwork availability >99.9%

Alarms / Alerts Annunciation12711.4 Alarms / Alerts AnnunciationNote: An “Annunciation Delay” is the time that an alarm system deliberately delays the alarmannunciation (audibly and visually) to ensure clinical relevance of the detected alarmingcondition. Within the tables below, see column “Annunciation Delay” for the pre-definedperiods of time.Note: When the ViSi Mobile Monitor is connected to a network (as indicated by the networksymbol in the top left hand corner of the display), the audio annunciation of non-life-threatening alarms/alerts will be deferred to the ViSi Mobile Remote Viewer for a pre-configured period of time. Within the tables below, see column “Deferral Delays” for thepre-defined periods of time.11.4.1 Physiological Alarms (Alarms)Visual DisplayThe following table outlines the visual display when alarms are in progress:Audio TonesThe following table outlines the audio tones when alarms are in progress:Alarm Limits and Delays (factory default settings).Severity Indicator Attributes Toggle / Flash Speed Duty CycleHigh Priority Red 1.5 Hz 50% ONLife-Threatening Priority Red / White 1.5 Hz 50% ONSeverity Melodyaa. Melodies are defined as musical notes.Volume[dB] Frequency(fo) [Hz] Duration(td) [ms] Spacing(ts) [ms] 5th-6th[s] Inter-Burst(tb) [s]Life Threatening b5.b5.b5..b5.b5 78 987.767 100 50 0.35 2.5High b5.b5.b5..b5.b5 78 987.767 200 100 0.35 5Vital Sign Lower Limit Upper Limit Annunciation Delaya(seconds) Deferral Delay(seconds)Care Unit Patient Patient Care Unit Patient Care UnitbCritical Low HR (BPM) 18 18 N/A N/A 5 5 30Heart Rate (BPM) 30 30 150 200 5 5 60Pulse Rate (BPM) 30 30 150 200 30 30 60BP Systolic (mmHg) 70 OFF 190 240 60 30 90BP Diastolic (mmHg) 40 OFF OFF 150 60 30 90BP MAP (mmHg) 60 65 OFF 170 60 30 90

Alarms / Alerts Annunciation 128Respiration (BR/MIN) 4 4 35 40 120 60 90SpO2 (%) 85 85 N/A N/A 30 30 60Skin Temperature N/A N/A N/A N/A N/A N/A N/Aa. When measurement blood pressure as a 1-time measurement or at automatic intervals, there will be no annunciation delay.b. As the vital sign measurement approaches the care unit limit, the annunciation delay will decrease linearly.No Pulse Detected Alarms Limit DelaysAnnunciation DeferralWhen Thumb Sensor is primary source No Pulse No delay 60When Cuff Module is primary source No Pulse No delay 60Vital Sign Lower Limit Upper Limit Annunciation Delaya(seconds) Deferral Delay(seconds)Care Unit Patient Patient Care Unit Patient Care Unitb

Alarms / Alerts Annunciation129Battery AlarmsBattery Alarms Limit Delays (in seconds)Annunciation DeferralMonitorMonitoring Mode 45oC (113oF) No delay No deferralIn the Charger 45oC (113oF) No delay N/ANot monitoring / Not in the Charger 45oC (113oF) No delay N/ACuffModuleConnected to the Monitor 45oC (113oF) No delay No deferralIn the Charger 45oC (113oF) No delay N/ANot monitoring / Not in the Charger 45oC (113oF) No delay N/A

Alarms / Alerts Annunciation 13011.4.2 Equipment Alarms (Alerts)Visual DisplayThe following table outlines the visual display when alerts are in progress:Audio TonesThe following table outlines the audio tones when alerts are in progress:Note: There are no audio tones associated with low severity alerts.Alarm Limits and Delays (factory default settings)Severity Indicator Attributes Toggle / Flash Speed Duty CycleAll Severities Cyan (Blue) Constant (ON) 100% ONSeverity Melodyaa. Melodies are defined as musical notes.Volume[dB] Frequency(fo) [Hz] Duration(td) [ms] Spacing(ts) [ms] Inter-Burst(tb) [s]High e5.c5 68/63 659.255, 523.251 250 250 15Chest Sensor Alerts Limit(if applicable) AudibleAlertDelays (in seconds)Annunciation DeferralECG Lead Failure N/A No No delay N/AAll ECG Lead Failure N/A No No delay N/AChest Sensor Disconnected N/A No No delay N/AGeneral Fault Detected N/A No No delay N/AMultiple Connections N/A No No delay N/ATemperature Sensor Fault N/A No No delay N/AAccelerometer Fault - Chest Module N/A No No delay N/AAccelerometer Fault - Upper Arm N/A No No delay N/AThumb Sensor Alerts Limit(if applicable) Audible AlertDelays (in seconds)Annunciation DeferralThumb Sensor Off N/A No < 30 N/AThumb Sensor Disconnected N/A No No delay N/A

Environmental Conditions13111.5 Environmental ConditionsCuff Module Alerts Limit(if applicable) Audible AlertDelays (in seconds)Annunciation DeferralLow Battery 4% to 10% No No delay N/ABattery Empty < 4% No No delay N/ACheck Cuff N/A No No delay N/ACuff Occluded N/A No No delay N/ANIBP Unobtainable N/A No No delay N/AInvalid Software Loaded N/A No No delay N/APressure Accuracy Fault N/A No No delay N/AGeneral Fault Detected N/A No No delay N/APressure Exceeded 300mmHg Yes No delay No deferralMultiple Connections N/A No No delay N/AWrist Monitor Alerts Limit(if applicable) Audible AlertDelays (in seconds)Annunciation DeferralCalibrate cNIBP N/A N/A No delay N/ALow Battery 3 hours No No delay N/ACritical Low Battery 1 hour No No delay N/AToo Low to Monitor 10 minutes No No delay N/AInvalid Plug Connected N/A Yes No delay No deferralAudio System Failure N/A No No delay N/AWireless Radio Failure N/A No No delay N/AAll Sensors Disconnected N/A No No delay N/AAccelerometer Failure N/A No No delay N/AShock Hazard N/A Yes No delay No deferralPatient Tampering(number of incorrect pin code entries)5 invalid pin codesNo No delay N/AEnvironmental Conditions for all ViSi Mobile Components(Monitor, Cuff Module, Chest Sensor Cable, Cuff, Thumb Sensor)Condition Storage(Packaged / Unpacked) Operating(Unpack aged)Temperature -20oC to +55oC (50oC for NIBP)-4oF to +131oF (122oF for NIBP)0oC to +50oC / 32oF to +122oFBattery Charger: 0oC to +40oCHumidity 15% to 95% non-condensing(90% for NIBP)10% to 95% non-condensing(90% for NIBP)

Environmental Conditions 132Atmospheric Pressure Range107 kPa to 50 kPa803 mmHg to 375 mmHg1.06 atm to 0.49 atm107 kPa to 70 kPa803 mmHg to 525 mmHg1.06 atm to 0.69 atmThe ViSi Mobile Monitor may not perform to specification if stored or shippedoutside the specified temperature range.Environmental Conditions for all ViSi Mobile Components(Monitor, Cuff Module, Chest Sensor Cable, Cuff, Thumb Sensor)Condition Storage(Packaged / Unpacked) Operating(Unpack aged)

Compliances13311.6 CompliancesObserve any national regulations on the qualification of the testing personnel and suitable measuring andtesting facilities. See User Maintenance on page 127 for a list of required tests.11.6.1 Federal Communications Commission (FCC)The equipment device complies with Part 15 of the FCC Rules. Operation is subject to the following twoconditions: (1) This device may not cause harmful interference, and (2) This device must accept anyinterference received including interference that may cause undesired operation.Changes or modifications not expressly approved by Sotera Wireless could void the user’s authority tooperate the equipment. Manufacturer is not responsible for any radio or TV interference caused byunauthorized modifications to this equipment.This equipment has been tested and found to comply with the limits for a Class B digital device, pursuantto Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmfulinterference in a residential installation. This equipment generates, uses and can radiate radio frequencyenergy and, if not installed and used in accordance with the instructions, may cause harmful interference toradio communications. However, there is no guarantee that interference will not occur in a particularinstallation. If this equipment does cause harmful interference to radio or television reception, which canbe determined by turning the equipment off and on, the user is encouraged to try to correct the interferenceby one or more of the following measures:• Reorient or relocate the receiving antenna• Increase the separation between the equipment and receiver• Connect the equipment into an outlet on a circuit different from that to which the receiver isconnected• Consult the dealer or an experienced radio/TV technician for helpThis device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to thefollowing two conditions: (1) this device may not cause interference, and (2) this device must accept anyinterference, including interference that may cause undesired operation of the device.Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts delicence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire debrouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si lebrouillage est susceptible d'en compromettre le fonctionnement.Class B digital device notice / “CAN ICES-3 (B)/NMB-3(B)”.This equipment complies with the FCC/IC radiation exposure limits set fourth for portable transmittingdevices operation in a controlled environment. End users must follow the specific operating instructions tosatisfy RF exposure compliance.The equipment should only be used where there is normally at least 22.651mm separation between theantenna and all person/user.This transmitter must not be co-located or operation in conjunction with any other antenna or transmitter.Any changes or modifications not expressly approved by the party responsible for compliance could voidthe user’s authority to operate this equipment.

Compliances 13411.6.2 Electromagnetic Compatibility (EMC) SpecificationsTake special precautions regarding electromagnetic compatibility (EMC) when using medical electricalequipment. Operate your monitoring equipment according to the EMC information provided in thismanual. Portable and mobile radio frequency (RF) communications equipment can affect medicalelectrical equipment.Accessories Compliant with EMC StandardsAll accessories (e.g. ViSi Mobile Charger) comply with either IEC 60601-1-2 or IEC 60950-1.Consult your Biomed department or vendors for assistance in identifyingEMC compliance status of other medical devices when using the ViSiMobile Monitoring System.Using accessories other than those specified may result in increasedelectromagnetic emission or decreased electromagnetic immunity of themonitoring equipment.

Compliances13511.6.3 Electromagnetic EmissionsThe ViSi Mobile Monitor is suitable for use in the electromagnetic environment specified in the tablebelow. Ensure that the Monitor is used in such an environment.Emissions Test Compliance Avoiding Electromagnetic InterferenceRadio Frequency (RF) emissions Group 1 The ViSi Mobile Monitor uses RF energy only for its internal functiona. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.a. The battery operated ViSi Mobile Monitor contains a 2.4 GHz DSSS transmitter for the purpose of wire-less communication. The radio is excluded for the EMC requirements of IEC 60601-1-2, but should be considered when addressing possible interference issues between this and other devices.RF emissions CISPR 11 Class A The ViSi Mobile Monitor is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage supply network that supplies buildings used for domestic purposes.Harmonic emissions IEC 61000-3-2 N/AVoltage fluctuations IEC 61000-3-3 N/A

Compliances 13611.6.4 Electromagnetic ImmunityThe ViSi Mobile Monitor is suitable for use in specified electromagnetic environment. The user mustensure that it is used in the appropriate environment as described below.In the above table, UT (Unit in Test) is the ViSi Mobile Monitoring System.Immunity Test IEC 60601-1-2 Electromagnetic Environment GuidanceTest Level Compliance LevelElectrostatic discharge (ESD)IEC 61000-4-2±6 kV contact±8 kV air±6 kV contact±8 kV airFloors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast transient / burstIEC 61000-4-4±2 kV for power supply lines±1 kV for input/output lines±2 kV for power supply lines±1 kV for input/output linesMains power quality should be that of a typical medical and/or hospital environment.SurgeIEC61000-4-5±1 kV differential mode±2 kV common mode±1 kV differential mode±2 kV common modeMains power quality should be that of a typical medical and/or hospital environment.Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11<5% UT(>95% dip in UT) for 0.5 cycles<5% UT(>95% dip in UT) for 0.5 cycles40% UT(60% dip in UT) for 5 cycles40% UT(60% dip in UT) for 5 cycles70% UT(30% dip in UT) for 25 cycles70% UT(30% dip in UT) for 25 cycles<5% UT(>95% dip in UT) for 5 sec<5% UT(>95% dip in UT) for 5 secPower frequency (50/60Hz) magnetic fieldIEC 61000-4-83 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical cial and/or hospital environment.

Compliances13711.6.5 Recommended Separation DistancePortable and mobile RF communications equipment should be used no closer to any part of the ViSiMobile Monitor, including cables, than the recommended separation distance calculated from the equationappropriate for the frequency of the transmitter.Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be lessthan the compliance level in each frequency range.In the following table, P is the maximum output power rating of the transmitter in watts (W) according tothe transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from fixed transmitters, such as base stations for radio (cellular, cordless) telephones andland mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predictedtheoretically with accuracy. To access the electromagnetic environment due to fixed RF transmitters, anelectromagnetic site survey should be considered. If the measured field strength in the location in whichthe ViSi Mobile Monitor is used exceeds the applicable RF compliance level above, the Monitor should beobserved to verify normal operation. If abnormal performance is observed, additional measures may benecessary, such as reorienting or relocating the Monitor.These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorptionand reflection from structures, objects and people.The ViSi Mobile Monitor may be temporarily interrupted by UHF RFIDSystems (860-960MHz).Interference may occur in the vicinity of equipment marked with this symbol:Immunity Test IEC 60601-1-2Test Level ViSi Mobile Monitoring System Compliance Level Electromagnetic Environment GuidanceConducted RFIEC 61000-4-63 VRMS150 kHz to 80 MHz3 VRMS Recommended separation distance:d = 1.2√PRadiated RFIEC 61000-4-33 V/m80 MHz to 2.5 GHz3 V/m Recommended separation distance:80 MHz to 800 MHz80 MHz to 800 MHzd = 3.5√P800 MHz to 2.5 GHzd = 2.3√P2.0 to 2.3 GHz for short radiod = 7.0√P

Compliances 138From Portable and Mobile RF Communication EquipmentThe ViSi Mobile Monitor is intended for use in an electromagnetic environment in which radiated RFdisturbances are controlled. The customer or user of the Monitor can help prevent electromagneticinterference by maintaining a minimum distance between portable and mobile RF communicationsequipment and the Monitor as recommended below, according to the maximum output power of thecommunications equipment.In the following table, P is the maximum power output rating of the transmitter in watts (W) according tothe transmitter manufacturer and d is the recommended separation distance in meters (m).Electrosurgery Interference/Defibrillation/Electrostatic DischargeThe equipment returns to the previous operating mode within 10 seconds without loss of any stored data.Measurement accuracy may be temporarily decreased while performing electrosurgery or defibrillation.This does not affect patient or equipment safety. Do not expose the equipment to x-ray or strong magneticfields (MRI).Fast Transients/BurstsThe equipment will return to the previous operating mode within 30 seconds without loss of any storeddata.Frequency 150 kHZ to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHzEquation d = 1.2√Pd=1.2√Pd=2.3√PRated max. output power of transmitterSeparation Distance Separation Distance Separation Distance(m) (ft) (m) (ft) (m) (ft)0.01 W 0.1 0.4 0.1 0.4 0.2 0.80.1 W 0.4 1.2 0.4 1.2 0.7 2.41 W 1.3 3.9 1.3 3.9 2.3 7.510 W 3.8 12.4 3.8 12.4 7.3 23.9100 W 12.0 39.4 12.0 39.4 23.0 75.5

Compliances13911.6.6 StandardsAgency Compliances• ANSI/AAMI EC13, Cardiac monitors, heart rate meters, and alarms• ANSI/AAMI EC53, ECG cables and lead-wires.• CAN/CSA C22.2 No 601.1 M90 Part 1: General requirements for basic safety and essential performance• EN 1060-1:1995 Non-invasive sphygmomanometers - Part 1: General requirements• EN 1060-3:1997 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems• IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety• IEC 60601-1-2, Med. Elect. Equipment – Part 1-2: General requirements for safety – Collateral standard: EMC – Req. and tests.• IEC 60601-1-4, Medical electrical equipment - Part 1-4: General requirements for safety – Collateral stan-dard: Programmable electrical medical systems• IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements – Collateral standard: Usability.• IEC 60601-1-8, Medical electrical equipment – Part 1-8: Gen. req. – Col. Std. Gen. requirements, tests and guidance for alarm systems• IEC 60601-2-27, Medical electrical equipment, Part 2-27: Particular requirements or the safety, including essential performance, of ECG monitoring equipment• IEC 80601-2-30, Medical electrical equipment – Part 2-30: Particular requirements for the safety, including essential performance, of auto. cycling non-invasive BP monitoring equipment.• IEC 60601-2-49, Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multi-function patient monitoring equipment.• ISO 9919, Medical electrical equipment - Particular requirements for the basic safety and essential perfor-mance of pulse oximeter equipment for medical use. • ISO 81060-2, Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.• UL 60601-1 Part 1: General requirements for basic safety and essential performance

Wireless Network Risk Mitigation 14011.7 Wireless Network Risk MitigationReference: ISO 80001-1ViSi Mobile System utilizes the Responsible Organization’s wireless IT network to communicate betweenindividual ViSi Mobile Monitors connected to patients and the ViSi Appliance. Physiologic data andalarms originating from the ViSi Mobile Monitors are transmitted over the IT network to the ViSi MobileRemote Viewer where supplemental alarm notification occurs. Reliability of the IT network is essential inensuring the supplementary alarm notification meets the intended use.11.7.1 Risk Analysis Summary• The ViSi Mobile Monitors are the source of all alarms and alerts. • The ViSi Mobile Remote Viewer provides a supplemental alarm notification. When connectivityis present audio alarms are deferred to the ViSi Mobile Remote Viewer.• In the event that network connectivity is lost, all audio alarms are annunciated at the ViSi MobileMonitors. A connectivity lost alert is annunciated at the ViSi Mobile Remote Viewer.11.7.2 Residual RisksLoss of network connectivity will result in failure in supplemental alarm notification to the ViSi Applianceand ViSi Mobile Remote Viewer. Management of this risk is the responsibility of the ResponsibleOrganization for the IT Network. This risk is minimized with the following mitigations:Sotera Responsibilities• Sotera Inc network assessment prior to installation.• Sotera Inc verification that the Responsible Organization network meets ViSi Mobile Systemconnectivity requirements at the time of installation.• Hand over protocol with all settings/configurations as installed and configured (Training)Responsible Organization Responsibilities• Conduct a risk assessment of the IT Network prior to installation and mitigate technical risk.• Maintain backup and emergency power resources for ViSi System network components.• Maintain network configuration post installation of the ViSi Mobile System.• Notify Sotera prior to modifications to the network, including any configurations changes thatcould potentially compromise the IT Network as verified at the initial installation of the ViSiSystem. For support contact Sotera Wireless or an authorized Sotera Wireless representative inyour area.Other RF radiating devices (such as high powered RFID readers and Bluetoothdevices) that are in close proximity with the ViSi Mobile Monitor may interfere with theMonitor’s wireless communications. During such interference, the Monitor continuesto monitor and will alarm locally. If wireless communication is affected when using theMonitor in close proximity with another RF radiating device, move the other deviceaway from the Monitor or discontinue use of the other device.Perform a risk assessment and verification before implementing a change ormodification to the IT infrastructure. Changes to IT network configurations cancompromise continuous vital signs monitoring and alarm delivery.

Wireless Network Risk Mitigation141- Notes -

Wireless Network Risk Mitigation 142

143Appendix A - Alarm SummaryPatient AlarmsLife Threatening AlarmsNote: When the Cuff Module is in the Charger, the LED on the front of the Cuff Module willdisplay red.Display Message Symbol(s) Alarm Summary CauseCRITICAL LOW HR Critical Low Heart Rate Patient’s heart rate is less than 18 BPM.Note: The patient’s posture willtoggle white/red.MONITOR TOO HOT Monitor - Battery Over-Temperature Failure• Battery in the Monitor has exceeded a safe temperature.• The Chest Module has exceeded a safe temperature.Return the Monitor and the Chest Sensor to Sotera Wireless.CUFF BATTERY TEMPCuff Module - Battery Over-Temperature FailureBattery in the Cuff Module has exceeded a safe temperature.Return the Cuff Module to Sotera Wireless.When the “Monitor Too Hot” alarm is in progress, ViSi Mobile MonitoringSystem should be removed from the patient immediately. Leaving on thepatient for an extended period of time may lead to a skin burn.When the “Cuff Battery Temp” alarm is in progress, ViSi Mobile Cuff Moduleshould be removed from the patient immediately. Leaving on the patient foran extended period of time may lead to a skin burn.

Patient Alarms 144High Alarms Display Message Alarm Summary CauseTHUMB NO PULSE SpO2 Module - No Pulse DetectedUnable to detect a pulse from the Thumb Sensor.Thumb Sensor is the primary source of PR.CUFF NO PULSE Cuff Module - No Pulse DetectedChest Sensor Cable and Thumb Sensor are not connected. Cuff Module is the only source of PR. Unable to detect a pulse from the cuff inflation.HIGH PULSE RATE High Pulse Rate Pulse rate exceeds the defined upper alarm limit.LOW PULSE RATE Low Pulse Rate Pulse rate is less than the defined lower alarm limitHIGH HEART RATE High Heart Rate Heart rate exceeds the defined upper alarm limit.LOW HEART RATE Low Heart Rate Heart rate is less than the defined lower alarm limit.HIGH BP SYSTOLIC BP - High Systolic Systolic pressure exceeds the defined upper alarm limit.LOW BP SYSTOLIC BP - Low Systolic Systolic pressure is less than the defined lower alarm limit.HIGH BP DIASTOLIC BP - High Diastolic Diastolic pressure exceeds the defined upper alarm limit.LOW BP DIASTOLIC BP - Low Diastolic Diastolic pressure is less than the defined lower alarm limit.HIGH BP MAP BP - High MAP MAP pressure exceeds the defined upper alarm limit.LOW BP MAP BP - Low MAP MAP pressure exceeds the defined lower alarm limit.HIGH RESP High Respiration Respiration exceeds the defined upper alarm limit.LOW RESP Low Respiration Respiration is less than the defined lower alarm limit.LOW SpO2Low SpO2SpO2 is less than the defined lower alarm limit.

Equipment Alerts145Equipment AlertsViSi Mobile Monitor AlertsDisplay Message Symbol(s) Severity Cause SolutionAUDIO FAILURE Low Either the microphone or the speaker on the Monitor has failed.Stop monitoring and replace the Monitor. Return the Monitor to Sotera Wireless, Inc.WIRELESS RADIOLow The wireless radio in the Monitor is not transmitting.Stop monitoring and replace the Monitor. Return the Monitor to Sotera Wireless, Inc.MONITOR BATTERY CRITICALLow Monitor battery charge is critically low.Replace the Monitor.MONITOR BATTERY LOWLow Monitor battery charge is low.Prepare to replace the Monitor.UNABLE TO MONITORLow Battery in the Monitor is too low to continue monitoring.Replace the Monitor.CONNECT TO PATIENTN/A Low A sensor has been connected to the Monitor but not yet applied to the patient. No vital sign measurement has been detected.Apply the sensor to the patient.ACCEL MONITORLow Unexpected error occurred with the accelerometer in the Monitor.Replace the Monitor and return it to Sotera Wireless, Inc.

Equipment Alerts 146ViSi Mobile Chest Sensor Cable and ECG Alerts Display Message Severity Cause SolutionCHEST SENSOR Low The Chest Sensor Cable is disconnected from the Monitor and not yet acknowledged by the clinician. Acknowledge the alert and remove the Chest Sensor Cable from the patient, or reconnect the Chest Sensor Cable to the Monitor.Low More than one Chest Sensor Cable is simultaneously connected to the Monitor.Remove the extra Chest Sensor Cable(s) from the Monitor.CHEST FAULT Low Various failure modes related to the Chest Sensor Cable.Replace the Chest Sensor Cable and return it to Sotera Wireless, Inc.Low The Chest Sensor Cable does not contain the correct software.Replace the Chest Sensor Cable and return it to your biomedical engineer.ECG LEAD (+ lead label)Low One or more lead-wires have failed. Reconnect the ECG electrode, if necessary.Replace the ECG electrode, if necessary.ECG LEADS Low All ECG lead-wires have failed. Reconnect the lead-wires to the ECG electrodes. Replace the ECG electrodes if necessary.TEMPERATURE FAULTLow Unexpected error occurred with the Temperature Sensor.Replace the Chest Sensor Cable and return it to Sotera Wireless, Inc.ACCEL. CHEST Low Unexpected error occurred with the accelerometer in the Chest Sensor Cable.Replace the Chest Sensor Cable and return it to Sotera Wireless, Inc.ACCEL. UPPER ARMLow Unexpected error occurred with the Upper Arm accelerometer.Replace the Chest Sensor Cable and return it to Sotera Wireless, Inc.Use all of the same type of high quality ECG electrodes on the patient.Mixing ECG electrode types can adversely affect ECG monitoring.

Equipment Alerts147ViSi Mobile Thumb Sensor and SpO2 Alerts ViSi Mobile Cuff Module and NIBP Alerts Display Message Severity Cause SolutionTHUMB SENSOR Low The Thumb Sensor has been disconnected from the Monitor and has not yet been acknowledged by the clinician.Acknowledge the alert, or reconnect the Thumb Sensor to the Monitor.THUMB SENSOR OFFLow The optical signal has been lost. Reposition the Thumb Sensor at the base of the patient’s thumb. Replace the Thumb Sensor.Display Message Severity Cause SolutionCHECK CUFF Low An issue has been found with the cuff during inflation Check the connection between the Cuff and the Cuff Module.Check the Cuff for damage.CUFF OCCLUDED Low Something is blocking the air from being pumped into the Cuff. Check for a kinked hose. Check to make sure that the connection between the Cuff and the Cuff Module is not blocked.NIBP UNOBTAINABLELow NIBP measurement is unobtainable. Make sure that the Cuff is positioned on the arm correctly, and wrapped snugly around the arm.CUFF MODULE Low The Cuff Module is disconnected from the Monitor and the alert is not yet acknowledged by the clinician.Acknowledge the alert and either reconnect the Cuff Module to the Monitor or remove the Cuff Module from the Cuff and remove the Cuff from the patient.Low More that one Cuff Module is simultaneously connected to the Monitor.Remove the extra Cuff Module(s) from the Monitor.CUFF MODULE300 mmHgHigh A pressure of 300mmHg was reached when inflating the Cuff.Check the patient. Make sure that the Cuff is positioned on the arm correctly, and wrapped snugly around the arm.

Equipment Alerts 148CALIBRATION FAILEDLow An attempt to calibrate cNIBP has failed.• Make sure the cuff is positioned on the arm correctly and wrapped snugly around the arm.• Ensure the patient remains still during the calibration process.CALIBRATE cNIBP Low A recalibration event has occurred.Calibrate cNIBP.NIBP FAULT Low Cuff accuracy “zero pressure” test failed.Return the Cuff Module to your biomedical engineer. Replace with another Cuff Module.Low The Cuff Module does not contain the correct software.Replace the Cuff Module and return it to your biomedical engineer.Low This can indicate various failure modes related to the Cuff Module.Replace the Cuff Module and return it to Sotera Wireless, Inc.NIBP LOW BATTERY Low Battery in the Cuff Module is low. Replace the Cuff Module with one that has a full battery charge.NIBP EMPTY BATTERYLow Battery in the Cuff Module is empty. No measurements are possible. Replace the Cuff Module with one that has a full battery charge.Display Message Severity Cause Solution

Equipment Alerts149Miscellaneous AlertsViSi Mobile Charging AlertsDisplay Message Symbol(s) Severity Cause SolutionINVALID PLUG High During monitoring the Bio Med or Shipping Plug has been connected to the rounded end of the Monitor.Remove the invalid Plug.PATIENT TAMPERINGLow Someone has unsuccessfully attempted to log into the Monitor. Enter the correct PIN and check settings to confirm nothing has changed.SENSORS DISCONNECTLow All sensor connections to the Monitor have been removed without going through the Stop Monitoring process. Either reconnect the sensor(s) to the Monitor or stop monitoring using the Stop Monitoring process.SHOCK HAZARDHigh Cuff Module has been placed in the Charger while still connected to the Monitor.Remove the Cuff Module from the Charger or disconnect the Cuff Module from the Monitor.Display Message Severity Cause SolutionCHARGE CURRENT FAULTHigh Monitor charging over current protection error.Remove the Monitor from the Charger and contact Sotera Wireless, Inc. Customer Service.CHARGE TEMP FAULTHigh Monitor charging over temperature protection level.Remove the Monitor from the Charger and contact Sotera Wireless, Inc. Customer Service.CHARGE VOLTAGE FAULTHigh Voltage level has exceeded the limit when the Monitor is in the Charger.Remove the Monitor from the Charger and contact Sotera Wireless, Inc. Customer Service.

ViSi Mobile Monitor Status Icons 150ViSi Mobile Monitor Status IconsBattery ChargeWireless Radio Signal StrengthBattery Icon StatusThe battery status in the ViSi Monitor is good.Note: The fill level will diminish as the battery level goes down.The battery in the ViSi Monitor is low.There is less than 3 hours of monitoring available.The battery in the ViSi Monitor is critically low.There is less than 1 hour of monitoring available.The battery in the ViSi Monitor is too low to continue monitoring.There is less than 10 minutes of battery charge left.Signal Strength Icon StatusConnectivity between the ViSi Monitor to the Appliance is good. The number of green bars indicate the signal strength.The ViSi Mobile Monitor recognizes the network but is unable to connect to the Appliance. The number of yellow bars indicates the signal strength.Connectivity between the ViSi Mobile Monitor and the Appliance has been lost.Note: This connectivity lost icon is only displayed on the ViSi Mobile RemoteViewer.

151Appendix B - SymbolsAlarms / AlertsAlarm / Alert StatesSymbol DescriptionUnacknowledged life threatening severity alarm in progress.Unacknowledged high severity alarm in progressUnacknowledged alert in progress (any severity).All alarms in progress have been acknowledged by the clinician.Alarm annunciation (visual and audio) has been paused for 2 minutes.Alarm annunciation (visual and audio) has been turned off.

Alarms / Alerts 152Alarm ManagementSymbol DescriptionPause alarm annunciation (visual and audible) for 2 minutes.Turn off alarm annunciation (visual and audible).Resume alarm annunciation from a paused state.Turn alarm annunciation back on.Acknowledge an alarm/alert that is in progress.

Battery States153Battery StatesSymbol DescriptionBattery good: the Monitor’s battery is fully charged.Battery Low: the Monitor’s battery voltage is low.Battery Critically Low: the Monitor’s battery voltage is critically low.

General Icons 154General IconsOut of Range Vital SignsNavigationVital Signs MenuSymbol Description+++ Vital sign measurement is above the upper display range.--- Vital sign measurement is below the lower display range.Unlock the ViSi Mobile Monitor to gain access to the clinical features.Lock the ViSi Mobile Monitor to prevent unwanted access to the clinical features.Confirm activity.Cancel activity.Return to the previous screen.Symbol DescriptionAccess to the clinical menu.Start a manual cuff inflation. Cuff inflations are set up to be taken on an ad hoc basis.Start a manual cuff inflation. Cuff inflations are set up to be taken automatically at a selected time interval.Start a manual cuff inflation. Blood pressure measurements are set up to be continuous after the initial calibration.

General Icons155Clinical MenuCalibrate NIBP for continuous measurements.Stop a cuff inflation currently in progress.Symbol DescriptionBP management. Setup the cuff inflation intervals or define as ad-hoc only inflations.Initiate the pause/stop monitoring sequence.Initiate the stop monitoring sequence.Initiate the pause monitoring sequence.Access information regarding the ViSi Mobile Monitor: Monitor ID, MAC address, Serial #, software version installed and battery status.Alarm management. Review the patient’s current alarm limits, adjust the alarm limits using “Auto Set” or turn off the alarm annunciation.QRS beep is turned on.QRS beep is turned off.Symbol Description

General Icons 156OtherSymbol DescriptionChange a patient’s alarm limits using “Auto Set”.Setup cuff inflation to be on an ad hoc basis.Setup cuff inflation such that the cuff will inflate at defined intervals.Setup cuff inflation such that NIBP measurements will be taken on a continuous basis.

Patient’s Postures157Patient’s PosturesUnknown PosturePosturesNote: In the event of an alarm, the patient’s posture will be displayed in the color associated withthe alarm severity.Symbol DescriptionPatient is currently out of the network.aa. The ViSi Mobile Monitor always displays the question mark in gray irrespective of the alarm status.Patient’s posture has not been selected and confirmed on the ViSi Mobile Monitor. There are no alarm conditions in progress.Patient’s posture has not been selected and confirmed on the ViSi Mobile Monitor. A life-threatening alarm condition is in progress.bb. In the event of a life-threatening alarm, the question mark above the patient symbol will toggle white/red.Patient’s posture has not been selected and confirmed on the ViSi Mobile Monitor. When the question mark is static red, a high alarm condition is in progress.Symbol DescriptionPatient’s torso is in an upright position.Patient’s torso is at a reclined position.Patient is lying in a supine position.Patient is lying on their front.Patient is lying on their right side.Patient is lying on their left side.

Labelling 158LabellingSymbol DescriptionWarning, refer to accompanying documentsCaution, refer to accompanying documentsWiFi Alliance certificationConforms with EEC directivesCatalog numberSerial NumberManufactured ByDefibrillator proof type CF equipmentThis product is designated for separate collection at an appropriate collection point. Do not dispose of as household waste.Lithium Ion batteryIPX0 No special protection.IPX7 Protected against water immersion. Immersion for 30 minutes at a depth of 1 meter.Latex freeDo not reuseFragile

Labelling159ContentsMRI UnsafeSymbol DescriptionCONT

Labelling 160- Notes -

161Appendix C - WarrantyWarrantySotera warrants to End User, for a period of one (1) year from the date of delivery, unless otherwise notedin specific documentation, that the products sold by Sotera will operate in accordance with Sotera’spublished documentation in effect on the date of delivery or Sotera will, at its sole discretion and expense,repair or replace the products. Replacements will be warranted for the remainder of the warranty period ineffect on the original product purchased, unless otherwise mandated by applicable law. Products includeSotera equipment only but does not include disposables / consumables. Sotera warrants that itsdisposables / consumables products will be free from defects in workmanship and materials for a period ofone (1) year from the date of purchase or the expiration date whichever occurs first.Third Party Branded ProductsSotera will not be deemed to provide, nor be responsible for, warranty, related remedy or support withrespect to hardware, software or services purchased from a third party unless such party is a Soteraauthorized partner services Sotera Products and Services, unless otherwise agreed in writing between theparties.Typically, in case of a defective 3rd party item under warranty, Sotera will make arrangements with the 3rdparty manufacturer to issue a replacement. The replacement will be sent directly to the End User site fromthe 3rd party manufacturer. No Return Material Authorization (RMA) will be issued by Sotera, instead aSotera Case Number will be issued for the reported issue. The End User is responsible for complying withthe manufacturer’s replacement procedures.Warranty ExclusionsSotera will not be liable under this warranty if its testing and/or examination discloses that the allegeddefect in the Sotera equipment does not exist or was caused by end user’s or any unauthorized thirdperson’s misuse, neglect, improper installation or testing, attempts to repair, or any other cause beyond thescope of the intended use, or by accident, fire, lightning or other hazard or event of force majeure. Thewarranty for any hardware will become void if a hardware component is installed as an add-on and orreplacement part on the original hardware and such component part has not been approved for suchinclusion by Sotera. The warranty for software will voided if the software is modified, except as authorizedin writing by Sotera.

Sotera Wireless Responsibility 162In no event shall Sotera be liable to end user or any third parties for any consequential, incidental, indirect,exemplary, punitive, contingent, statutory or any other special damages. Sotera’s liability for damages onaccount of a claimed defect in any product delivered by Sotera shall in no event exceed the purchase priceof the product on which the claim is based. Specifically, and without limiting the generality of theforegoing, Sotera shall not be responsible or liable to end user or any third party for any lost profits, or anyconsequential, incidental, punitive, contingent, statutory or any other special damages for any breach ofwarranty or other breach of Sotera’s obligations under this agreement. Sotera shall not be liable fordamages relating to any instrument, equipment, or apparatus with which the product sold under thisagreement is used. In addition, Sotera disclaims all liability of any kind of Sotera’s suppliers.The foregoing warranties and remedies are exclusive and are in lieu of all other warranties, express orimplied, either in fact or by operation of law, statutory or otherwise including warranties of merchantabilityand fitness for a particular purpose or non infringement. Sotera does not assume or authorize any other person to assume for it any other or greater liability inconnection with the sale, installation, servicing, maintenance or use of Sotera hardware, and Sotera makesno warranty whatsoever with respect to any third-party branded products supplied by it hereunder.Sotera Wireless ResponsibilitySotera Wireless Inc. is responsible for the effects on safety, reliability and performance of the equipmentonly if:1. Assembly operations, extensions, readjustments, modifications or repairs are carried out bypersons authorized by Sotera Wireless Inc. and2. The equipment is used in accordance with the instructions for use.Contact Sotera WirelessToll-Free: +1-866-232-6126International: +1-858-427-4620Fax: +1-858-427-4639E-mail: support@soterawireless.com

163IndexAADT Interface 50Search Patients Within ADT 51Select Patients from ADT 50Alarm Limts 81Change Alarm Limits Individually 81Reset to Default Values 83Alarm Summary 143Alarms 69In Network Rules 70Managing Annunciations 72Physiological AlarmsHigh 75Life Threatening 73Resume Alarm Annunciation 79System Alarm Management 69Test Remote Viewer Speaker 84Turn Alarms On 80AlertsCharging 149Chest Sensor Cable 146Cuff Module 147ECG 146Miscellaneous 149Monitor 145SpO2 147Thumb Sensor 147CCare Unit Views 91Devices (Assigned To Patients) 91Cautions 20Contraindications 10Copyright 2Current Waveforms 65ECG Waveforms 65

164Input Overload/Dynamic Range 66Customer Support 93, 162EEdit Patient Demographics 45Equipement/Technical Alerts 77GGraphical Trends 56Alarms/Events Status Bar 60All Vital Sign Trends 57Patient Alarms 60Single Vital Sign Trend 58Time Cursor 59IIntended Use 10LList Trends 62, 65Navigation/Scrolling 64Trend Displays 64NNavigation 33Current Waveforms 65Graphical Trends 57List Trends 63Patient Home 33, 34Remove Patient 88NIBP 147PPatient Locations 47Drag and Drop 47Manual Data Entry 48Patient Reports 67List Trends 67Waveforms 68Patient Tiles 29Assigned Location Zone 29Unassigned Location Zone 30Work Area 31Patient ViewsAdmit New Patient 41ADT Patient Search 51Edit Patient Demographics/Assign a Location 45, 48Graphical TrendsMultiple Trends 57Single Trend 58

165List Trends 63Patient Demographics (Source ADT) 50Patient Home 28Remove Patient 88Pause Monitoring 85Physiological AlarmsHigh 144Life Threatening 143Pre-Admit New Patient 41RRemote Viewer Audio Test 84Remote Viewer Display 26Care Unit Area 26Assigned/Pre-Defined Locations Zone 26Unassigned Patients Zone 26Work Area 27Removing Patients (from Care Unit) 88SShutdown Application 36Specifications 105Physical Components 1182-Bay Charger 1238-Bay Charger 123Appliance 124Chest Sensor Cable 120Cuff Module 121Customer Network 126Mode Plugs 119Monitor 118Remote Viewer 125Thumb Sensor 122Wireless Communication/Radio 118Vital SignsContinuous Non-Invasive Blood Pressure 114Heart Rate 106Non-Invasive Blood Pressure 112Pulse Oximetry 110Respiration 109Skin Termperature 117Start Monitoring Before Admit 43Stop Monitoring 87Symbols 151Alarms/Alerts 151Battery States 153Battery Status 150

166Generic Icons 154Labelling 154Wireless Radio Signal Strength 150System Help 35System Overview 25TTime Scale Displays 59Trend Lines 59Troubleshooting 93Alarms and Alerts 102Battery Charger 101Chest Sensor Cable 95Connectivity Lost 102Cuff Module 99Monitor 94Setting Alarm Limits (Remote Viewer) 104Thumb Sensor 98VVital Sign Measurements 53Vital Signs MeasurmentsCare Unit Area 53WWarnings 12Warranty 161Exclusions 161Third Party Products 161Wireless Monitoring 37Communication with the Remote Viewer 38Out of Network Range 39