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Sotera VISI User Manual

Mobile monitoring system
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Monitoring System
User manual
Reference Number (Hardcopy): 95-10060
10020 Huennekens Street
San Diego, California 92121 USA
Phone: +1 (866) 232-6126 (U.S.)
+1 (858) 427-4620 (Intl)
Fax:
+1 (858) 999-2487
Email: support@soterawireless.com
EMERGO EUROPE
Molenstraat 15, 2513BH
The Hague
The Netherlands
1
Reference Number (USB): 95-10134
Part Number: 6-000212-15
®
Wireless, Inc. or an authorized Sotera
July2015
0297

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  • Page 1 +1 (858) 427-4620 (Intl) Fax: +1 (858) 999-2487 Email: support@soterawireless.com EMERGO EUROPE Molenstraat 15, 2513BH The Hague The Netherlands For additional information or assistance, please contact Sotera ® Wireless, Inc. or an authorized Sotera Wireless, Inc. representative in your area. 0297...
  • Page 2 Except as expressly provided in any written license agreement from Sotera Wireless, Inc., the furnishing of this document does not give you any license to these patents, trademarks, copyrights, or other intellectual property.

  • Page 3: Table Of Contents

    Contraindications........... . . 12 Chapter 2. ViSi Mobile Warnings and Cautions .
  • Page 4 ViSi Mobile CableChest Sensor Securements........
  • Page 5 Selecting the ViSi Mobile Disposable Kit........60...
  • Page 6 ViSi Mobile Remote Viewer/Appliance ........109...
  • Page 7 ViSi Mobile Battery Charger ........155 ViSi Power Pack (Optional Accessory) ....... 156 General Troubleshooting.
  • Page 8 ......203 ViSi Mobile Cuff Module and NIBP Alerts ....... 203 ViSi Power Pack Alerts .
  • Page 9 To check the battery charge of the ViSi Power Pack ......
  • Page 10 Warranty Exclusions ..........233 Sotera Wireless, Inc. Responsibility........234...
  • Page 11 - Notes -...

  • Page 13: Chapter 1. Preface

    1. Preface 1.1 Introduction The suite of ViSi Mobile Monitoring System user manuals are intended to provide information for the proper operation of the Sotera Wireless, Inc. ViSi Mobile Monitoring System. The suite of manuals consists of: • ViSi Mobile Monitoring System User Manual •...

  • Page 14: Intended Use

    • Do not use the ViSi Mobile Monitor System on a patient on cardio-pulmonary bypass. • Do not use the ViSi Mobile Cuff Module on a patient’s arm where the use of a blood pressure cuff is contraindicated. • Do not use the ViSi Mobile Monitoring System in an MRI Suite.

  • Page 15: Chapter 2. Visi Mobile Warnings And Cautions

    Please read and adhere to all warnings, cautions and notes listed here and in the associated sections throughout this manual. Do not operate the ViSi Mobile Monitoring System before reading these instructions. Warning statements alert the user to conditions or practices that could result in injury to a person, or serious adverse events associated with the use or misuse of the ViSi Mobile Monitoring System.

  • Page 16: Warnings

    The ViSi Power Pack is not intended to be worn by the patient. Do not modify the ViSi System in any way. Do not use the ViSi Mobile Monitor, Cuff Module, Chest Sensor or Power Pack in an MRI suite or a hyperbaric chamber.
  • Page 17 Power Pack from the patient, and then place it in the ViSi Mobile Charger. Do not touch the electrical contacts on the ViSi Power Pack or use the ViSi Power Pack without it first being inserted into the ViSi Power Pack Cradle. Doing so may result in electric shock from the battery.

  • Page 18: Disposable Components

    Do not clean the ViSi Mobile Monitor, Cuff Module, Chest Sensor, Thumb Sensor, or ViSi Power Pack with detergents while worn by the patient. Do not place the ViSi Mobile Monitoring System or ViSi Power Pack on or over an implanted programmable medical device.
  • Page 19 Remote Viewer. A qualified clinician must always be in direct view of the ViSi Mobile Remote Viewer. If the Remote Viewer display is blank, contact your biomedical engineer immediately for service.

  • Page 20: Vital Signs

    If a vital signs measurement is questionable, retake the measurement. If the result is still questionable, use a different method of measurement. ViSi Mobile blood pressure measurements (NIBP and cNIBP) have not been clinically evalu- ated in the presence of atrial or ventricular arrhythmias. Use alternative BP methods if these...

  • Page 21: Chest Sensor Cablechest Sensor: Ecg, Respiration, Temperature (Skin)

    ECG waveform or another method, such as a 12-lead ECG. The ViSi Mobile Monitor does not provide ST segment analysis. Therefore, if a change in the ST segment of the ECG waveform is suspected, it should be confirmed by another method, such as a 12-lead ECG.

  • Page 22: Cuff Module / Nibp

    The ViSi Mobile Disposable Cuff should be snug enough to support the Cuff Module while not impairing circulation when deflated. Avoid applying the ViSi Mobile Disposable Cuff over a wound as this can cause further injury. Avoid applying the ViSi Mobile Disposable Cuff on any limb where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present because of temporary interference to blood flow which could result in injury to the patient.

  • Page 23: Alarms / Alerts

    Ensure correct electrode placement and cable arrangement to minimize line isolation monitor transients. To avoid possible hearing damage, do not place your ear too close to the ViSi Mobile Monitor when it is alarming audibly. When the ViSi Mobile Monitor alarms or alerts, check the patient first to confirm that there is no immediate danger to the patient.

  • Page 24: User Maintenance

    Wireless Communications When the ViSi Mobile Monitor is not configured to connect to the facility’s network or loses wireless connection to the ViSi Mobile Appliance, the ViSi Mobile Remote Viewer does not receive patient alarms or alerts from the ViSi Mobile Monitor.

  • Page 25: Cautions

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

  • Page 26: Safety

    The ViSi Mobile Monitoring System or Power Pack are not intended for home use. Do not use the ViSi Mobile Monitoring System or Power Pack to monitor a patient in a wet environment, such as a shower.

  • Page 27: Service / Maintenance

    Sotera Wireless, Inc. technicians or authorized service providers. Equipment / Components If the ViSi Mobile Monitor is to be stored for an extended period of time, it is recommended the Monitor be stored with the Shipping Plug inserted to reduce the battery discharge.

  • Page 28: Cleaning / Disinfecting

    Do not clean the ViSi Mobile Monitor, the Cuff Module, or the Power Pack while it is plugged into the ViSi Mobile Charger. Do not apply liquid to the ViSi Mobile Cuff Module or the Power Pack. To clean, use a damp cloth.
  • Page 29 Note: Figures in this manual are provided for reference purposes only. Screens may differ based on the monitoring device configuration, licenses available, parameters selected and patient configuration of the ViSi Mobile Monitoring System. Note: All ViSi Mobile Monitoring System alarms and alerts annunciate with icons and colors that comply with IEC 60601-1-8.

  • Page 30: Notes

    Notes...

  • Page 31: Chapter 3. General Description

    (cNIBP), pulse oximetry (SpO ), and skin temperature (TEMP). The System consists of the ViSi Mobile Monitor, Thumb Sensor, Chest Sensor (either 3 lead-wire or 5 lead-wire), Cuff Module, Charger, Disposable Kit, and optional ViSi Power Pack. Powered by a rechargeable battery lasting at least 12 hours, the Monitor is a lightweight (weighing approximately 125 grams) portable patient vital signs monitor featuring a high resolution, full color display touchscreen with visual and audible alarms and alerts.

  • Page 32: Unpacking

    To insert the Shipping Plug Ensure that the ViSi Mobile Monitor is properly seated in the Wrist Cradle, the Plug is oriented with the connector contacts facing upwards, and push in firmly. The power down process begins. The power down cycle is complete once the screen goes blank and the green LED indicator has stopped blinking.

  • Page 33: System Components

    The Disposable Kits are available in five adult sizes: small, medium, medium+, large, and large+. Choose the Disposable Kit that contains the Cuff size best suited for the patient. Cuff sizes follow standard range of arm circumference. See 5.2.5 Selecting the ViSi Mobile Disposable Kit on page 60.

  • Page 34: Visi Mobile Disposable Cuff

    The Cuff is available in five adult sizes: small, medium, medium+, large and large+ (see 3.3.1 ViSi Mobile Disposable Kit on page 31). The Cuff is used to take a NIBP measurement once the Cuff Module is attached to the Cuff and plugged into the ViSi Mobile Monitor. See 3.3.4 ViSi Mobile Cuff Module on page Artery...

  • Page 35: Visi Mobile Wrist Cradle

    Flat End Wrist Cradle Strap Round End When inserting the ViSi Mobile Monitor into the Wrist Cradle, ensure proper alignment: flat end to flat end, with the round end pointing towards the wrist. ViSi Mobile Thumb Wrap The Thumb Wrap holds the Thumb Sensor and secures it to the base of the thumb.

  • Page 36: Visi Mobile Thumb Wrap

    There is one large and one small Chest Sensor Securement in the Disposable Kit. The large Securement secures the Chest Module of the Chest Sensorto the patient’s torso. The small Securement secures the Upper Arm Module of the Chest Sensorto the upper arm. See 3.3.5 ViSi Mobile Chest Sensor CableChest Sensor on page 38.

  • Page 37: Visi Mobile Cablechest Sensor Securements

    Insert with connector contacts facing upwards Note: The Thumb Sensor locks the ViSi Mobile Monitor into the Wrist Cradle and must be unplugged to remove the Monitor from the Wrist Cradle. Note: A Locking Plug should be used to lock the Monitor into the Wrist Cradle if the Thumb...

  • Page 38: Visi Mobile Thumb Sensor (Spo2/Pr)

    For ease of use, the Monitor features three interchangeable plug-in sites for the Chest Sensor, Cuff Module, and optional ViSi Power Pack. See “ViSi Power Pack” on page 207. The industry-standard technique of oscillometry is used for non-invasively taking single measurements of the systolic and diastolic blood pressure (NIBP) as well as pulse rate.

  • Page 39: Visi Mobile Cuff Module

    The Chest Sensor is either a 3 lead-wire or 5 lead-wire cable and plugs into any one of the connectors on the flat end of the Wrist Cradle. See 5.3.4 Applying the ViSi Mobile Chest Sensor CableChest Sensor and ECG Electrodes on page 69 for recommended Chest Sensor placement.

  • Page 40: Visi Mobile Chest Sensor Cablechest Sensor

    The Charger will beep once when it is connected to the AC power outlet. Note: When connected to the AC power outlet, if a fault with the ViSi Mobile Charger is detected, the Charger will audibly beep every second.
  • Page 41 The ViSi Mobile Charger provided by Sotera Wireless, Inc. is the required Charger for both the Monitor and the Cuff Module as well as for the optional ViSi Power Pack. The Charger is capable of charging up to eight of any combination of Monitors, Cuff Modules and Power Packs. To charge either the Monitor or the Cuff Module place the flat end into one of the slots with the front facing outwards.

  • Page 42: Visi Mobile Charger

    Charging the Monitor Insert the Monitor that you want to charge into one of the Charger docks. When the ViSi Mobile Monitor is in the Charger and a charging alert occurs, remove the Monitor from service. The Charge Status screen will be displayed briefly. The Monitor’s battery status indicator (in the top right...
  • Page 43 System Components Note: When the Monitor is in the Charger, the power indicator shows the charging state: Green: The Monitor is fully charged. Yellow: The Monitor is still charging The charge level (when the Monitor is in the Charger) is different from the monitoring time remaining (when the Monitor is out of the Charger).

  • Page 44: To Chargecharging The A Monitor

    When the red charging indicator is flashing, the battery in the Cuff Module has insufficient charge to take a measurement. No cuff inflations are possible. Charging the Optional ViSi Power Pack See “ Charging the ViSi Power Pack on page 212”...
  • Page 45 System Components...

  • Page 46: To Chargecharging The A Cuff Module

    System Components...

  • Page 47: Chapter 4. Clinical Features

    4. Clinical Features 4.1 Introduction The ViSi Mobile Monitor is completely body-worn and designed to continuously measure ECG/HR, SpO PR, RESP, and TEMP. The ECG, SpO , and RESP waveforms are viewable on demand. NIBP can be measured as a one-time measurement, automatically at predefined intervals or continuously.
  • Page 48 Introduction...

  • Page 49: Key Features

    The Monitor is powered by a rechargeable battery. For ease of use, the Monitor features interchangeable plug-in sites for the ViSi Mobile Chest Sensor and ViSi Mobile Cuff Module. The Chest Sensor measures the ECG/HR (with a 3 lead-wire or 5 lead-wire), RESP, and TEMP.

  • Page 50: Skin Temperature (Temp) Monitoring

    Thumb Sensor may result in erroneous measurements. 4.3.5 NIBP Monitoring The ViSi Mobile Cuff Module is intended for measuring arterial blood pressure (systolic, diastolic and MAP) using a Cuff. Measurements may be initiated manually (one at a time), automatically at selectable...
  • Page 51 Note: To measure continuous non-invasive blood pressure (cNIBP), the Cuff Module is only required for the initial inflation to determine the Pulse Arrival Time (PAT) and for periodic recalibrations. Avoid touching the ViSi Mobile Disposable Cuff during cuff inflation as it may disrupt the measurement.

  • Page 52: Display Screens

    Display Screens 4.4 Display Screens This section describes various screens displayed on the ViSi Mobile Monitor. Each screen is accessed by interacting with the touchscreen display. 4.4.1 Battery Charge Screen screen displays the battery status while the Monitor is charging in the Charger.

  • Page 53: Hibernation Screen

    Display Screens 4.4.2 Hibernation Screen screen (blank screen) is the default when no monitoring is currently in progress. Hibernation Power Indicator screen conserves battery power under the following conditions: Hibernation • The Shipping Plug is not plugged into the Monitor •...

  • Page 54: Vital Signs Screen

    Display Screens 4.4.3 Vital Signs Screen screen is the default screen that displays automatically (on initial setup) when sensors are Vital Signs placed on the patient and connected to the Monitor. Message area Start/Stop NIBP RESP Battery Status (Patient’s Primary ID) Calibrate cNIBP Indicator Pause...
  • Page 55 Note: Silence or enable the QRS/PR beep toneThe Select Patient’s Posture button will be enabled when the ViSi Mobile Chest Sensor is connected to the Monitor. Note: When turned on, the tone pitch of the heart beat will change with the level of oxygen saturation.

  • Page 56: Monitor Status Screen

    Display Screens Touchscreen Speaker Microphone Power Indicator Note: When the Monitor is not in the Charger, the power indicator shows the approximate monitoring time left: Green: Battery has at least 3 hours of monitoring time left. Yellow: Battery is low with less than 3 hours of monitoring time left. Red: Battery is critically low with less than 1 hour of monitoring time.
  • Page 57 Display Screens - Notes -...
  • Page 58 Display Screens...

  • Page 59: Chapter 5. Operation

    ViSi, please adhere to the following instructions related to patient set-up, initiating monitoring and the removal of the System. 5.2 Preparing for a New Patient In order to set up the complete ViSi Mobile Monitoring System, you will need the following components: • ViSi Mobile Disposable Kit (select size) •...

  • Page 60: Applying Sensors

    5.2.2 Applying Sensors Applying the sensors is simple and may be done in any order. At the completion of the setup, the components of the ViSi Mobile Monitoring System will be connected to the patient as shown in the diagram below.

  • Page 61: Selecting Vital Signs To Monitor

     PR (from NIBP) 5.2.4 Selecting the ViSi Mobile Chest Sensor The Chest Sensor provides the sensors to monitor the ECG, HR, RESP (optional), and TEMP. Note: The skin surface temperature sensor is on the underside of the Chest Module. It must be placed on the skin surface in order to properly measure skin surface temperature.

  • Page 62: Selecting The Visi Mobile Disposable Kit

    Disposable Kits are designated as S, M, M+, L and L+ based on the Cuff size. Selection of the correct ViSi Mobile Disposable Cuff size is necessary to ensure accurate NIBP measurements. A Cuff that is too small can result in a falsely high NIBP measurement.
  • Page 63 Preparing for a New Patient A red battery symbol indicates the battery is critically low with less than 30 minutes of monitoring time left. Fully Charged Battery Low Battery Critically Low Note: When the red bar is displayed on the screen, it indicates the Monitor will measure continuous blood pressure (cNIBP) when a Chest Sensor and Thumb Sensor are connected to a Monitor.

  • Page 64: To Check The Battery Charge Of The Cuff Module

    Preparing for a New Patient To check the battery charge of the Cuff Module Press the button on the front of the Cuff Module. Battery Status There is a row of eight colored lights on the front surface of the Cuff Module. Illuminated green lights indicate that the level of the battery charge is adequate for at least several NIBP measurements.

  • Page 65: Applying Visi Mobile Monitoring System / Initiate Monitoring

    5.3 Applying ViSi Mobile Monitoring System / Initiate Monitoring The ViSi Mobile Monitor may be used to monitor one vital sign, such as SpO , or multiple vital signs simultaneously. Apply the appropriate sensor for each vital sign to be monitored, as described below. Start by selecting the appropriately sized Disposable Kit (S, M, M+, L or L+).

  • Page 66: Applying The Visi Mobile Wrist Cradle

    3. Pull snugly and secure. Flat End Rounded The Wrist Strap should securely hold the ViSi Mobile Wrist Cradle in place without impairing circulation. Immediately loosen the Wrist Strap if the patient complains of pain, tingling, or numbness in the affected hand or wrist.
  • Page 67 Wrist Strap is snugly wrapped around the wrist. To avoid damage from dropping the ViSi Mobile Monitor while it is connected to the patient, secure the ViSi Mobile Monitor by plugging in the thumb sensor or locking key. 5. If you are not performing SpO monitoring, secure the Monitor to the cradle by inserting a Locking Plug into the opening on the rounded end of the Monitor.

  • Page 68: Applying Sensors

    You should hear a double-beep sound when a sensor is inserted correctly. 5.3.3 Applying the ViSi Mobile Thumb Sensor The ViSi Mobile Thumb Sensor is intended for use on the patient’s thumb, index and middle finger for SpO2 measurements; however, cNIBP can only be measured while on the patient’s thumb.
  • Page 69 The Thumb Wrap is designed to hold the Thumb Sensor in place securely without impairing circulation. Ensure that the ViSi Mobile Thumb Sensor is securely fastened. A Thumb Sensor that is wrapped too tightly or too loosely can adversely affect SpO2 measurement.
  • Page 70 PR are obtained. Re-secure the Thumb Sensor with the Thumb Strap. Note: Only use the ViSi Mobile Thumb Sensor provided by Sotera Wireless, Inc. with the ViSi Mobile Monitoring System. Using non-approved Thumb Sensors may result in inaccurate SpO2 readings or damaged equipment.

  • Page 71: Applying The Visi Mobile Chest Sensor Cablechest Sensor And Ecg Electrodes

    System. The Chest Sensor CableChest Sensor is designed to provide defibrillation protection as indicated in the Specifications section of this manual. ViSi Mobile is designed to be compatible with the use of external defibrillators. To ensure patient safety, the conductive parts of the ECG electrodes, including connectors and other patient-applied components, should not contact other conductive parts, or earth ground, at any time.

  • Page 72: Lead-Wire And Ecg Electrode Placement

    Applying ViSi Mobile Monitoring System / Initiate Monitoring 3 lead-wire and ECG Electrode Placement With the 3 lead-wire Chest Sensor, the ECG channel provides Lead II only. The ECG electrode placement shown in the diagram below is recommended for Lead II monitoring lead-wire Color Code - U.S.

  • Page 73: Lead-Wire And Ecg Electrode Placement

    Mid axillary line, in line with V5, or 5th intercostal space Note: Place the V lead in the position appropriate to your monitoring requirements: V1, V2, V3, V4, V5 or V6. Note: The ECG waveform can be displayed one lead at a time on the ViSi Mobile Monitor.

  • Page 74: To Apply The Chest Sensor Cablechest Sensor

    Note: The Chest Sensor should be oriented vertically, with the lead wires hanging downward. Do not orient the sensor more than a few degrees to the left or right. Note: Ensure the “Front”, “ViSi Mobile” and “Defibrillation” labels on the Chest Module of the Chest Sensor are facing outwards away from the patient’s skin.
  • Page 75 Note: Monitoring of ECG, HR, RESP (optional), and TEMP starts automatically. Alarm limits are set automatically according to predefined settings. Note: Only attach one ViSi Mobile Chest Sensor to the patient and ViSi Mobile Monitor. Insert with connectors contacts facing upwards 8.

  • Page 76: To Apply The Cuff Module

    Have the patient remain still to avoid the introduction of unnecessary motion artifact. Note: The ViSi Mobile Disposable Cuff is designed to be used on the same arm with the other ViSi Mobile sensors. It may temporarily cause the loss of function of other devices (not ViSi Mobile) simultaneously used on the same limb.

  • Page 77: Applying The Visi Mobile Cuff Module And Disposable Cuff

    Applying ViSi Mobile Monitoring System / Initiate Avoid applying the ViSi Mobile Disposable Cuff over a wound as this can cause further injury. Avoid applying the ViSi Mobile Disposable Cuff on any limb where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present because of temporary interference to blood flow which could result in injury to the patient.

  • Page 78: Removing Visi Mobile Monitoring System

    Note: Before removing ALL the ViSi Mobile Monitoring System components, you should either pause monitoring temporarily (see Pause Monitoring on page 139) or stop monitoring, if the patient will no longer be monitored (see Stop Monitoring on page 142).

  • Page 79: To Remove Cuff And Cuff Module

    Clinical Configurations 4. If the patient will no longer be monitored, dispose of the Wrist Cradle and Wrist Strap according to your facility’s policy. Clean the reusable components of the System: Monitor, Chest Sensor, Thumb Sensor, and Cuff Module, in accordance with your facility’s procedures and the cleaning recommendations in this manual.

  • Page 80: Clinical Configurations

    Clinical Configurations 5.5.2 Units of Measure Configuration Options Option Values Level Updateable Blood Pressure mmHg (default) Facility: yes Care Unit: no Temperature Facility: yes Fahrenheit ( F) (default) Care Unit: no Centigrade ( Date Display Format Mon DD, YYYY(default) Facility: yes DD Mon YYYY Care Unit: no MM/DD/YYYY...

  • Page 81: Skin Temperature Configuration

    Clinical Configurations b. When “Off” has been selected, the user will have full access to the clinical screens without having to authenticate with a 4-digit PIN before accessing. 5.5.5 Skin Temperature Configuration The Skin Temperature Configuration is an available option to turn “On” or “Off” within the Facility’s Care Unit.
  • Page 82 Clinical Configurations...

  • Page 83: Chapter 6. Alarms

    ViSi Mobile Monitor and the Remote Viewer for the “off” duration. Turning the alarms off must be done directly from the ViSi Mobile Monitor (worn by the patient), however, alarms may be turned back on from either the ViSi Mobile Monitor or the Remote Viewer.

  • Page 84: In Network Rules

    When the ViSi Mobile Monitor is in network and connected to the ViSi Mobile Remote Viewer: • When the ViSi Mobile Monitor is connected to the Remote Viewer, the audio alarm and alert tones will be deferred from the Monitor to the Remote Viewer, for a pre-configured length of time.

  • Page 85: Physiological Alarms (Alarms) / Technical Alarms (Alerts) Summary

    (Acknowledged for 2 minutes at both the Remote Viewer and Mobile Monitor.) a. Audio tones associated with alarms/alerts will only occur on the ViSi Mobile Monitor when the Monitor is not connected to a known network. Audio tones will always occur on the ViSI Mobile Remote...

  • Page 86: Managing Alarm/Alert Annunciations

    Allow Where Effects Pause Alarms/ 2 Minutes May only be paused Annunciation disabled at Alerts from the ViSi Mobile both the ViSi Monitor and Monitor. Remote Viewer. Resume Alarms/ ViSi Mobile Monitor and Annunciation resumed at Alerts Remote Viewer. both the ViSi Mobile Monitor and Remote Viewer.

  • Page 87: Responding To Physiological Alarms (Alarms)

    Responding to Physiological Alarms (Alarms) 6.3 Responding to Physiological Alarms (Alarms) 6.3.1 To Silence/Acknowledge Life Threatening Severity Alarms Life threatening severity alarms require urgent clinician response at the bedside. Symbol Annunciation Color Audio Tone Duration (ms) Spacing (ms) White / Red BBB P BB P BBB P BB...
  • Page 88 Responding to Physiological Alarms (Alarms) To silence/acknowledge the alarm, touch button Silence/Acknowledge Alarm - or - Touch the Alarm Status The alarm is silenced/acknowledged and the “Silenced/Acknowledged” symbol and countdown appear. After the 2 minute countdown expires, the alarm is re-annunciated. Silenced/Acknowledged symbol and countdown Note: When a Life Threatening alarm occurs and the alarming condition resolves itself before a...

  • Page 89: To Silence High Severity Alarms

    Responding to Physiological Alarms (Alarms) 6.3.2 To Silence High Severity Alarms High severity alarms require immediate clinician response at the bedside. Symbol Annunciation Color Audio Tone Duration (ms) Spacing (ms) BBB P BB P BBB P BB... B - Beep / P - Pause Silence/Acknowledge Alarm...
  • Page 90 Responding to Physiological Alarms (Alarms) To silence/acknowledge the alarm, touch button Silence/Acknowledge Alarm - or - Touch the Alarm Status The alarm is silenced/acknowledged and the silenced/acknowledged symbol and countdown appear. Silenced/Acknowledged symbol and countdown Note: When a high alarm occurs and the alarming condition resolves itself before a clinician is able to respond, the high alarm message appears (in gray) for up to 5 minutes in the message area.

  • Page 91: Responding To Equipment Alarms (Alerts)

    Responding to Equipment Alarms (Alerts) 6.4 Responding to Equipment Alarms (Alerts) 6.4.1 To Silence/Acknowledge Alerts (All Severities) Equipment alerts are used when the ability to monitor the patient and detect a patient’s physiological alarms may be affected. Annunciation Duration Spacing Symbol Severity Audio Tone...
  • Page 92 Responding to Equipment Alarms (Alerts) To silence/acknowledge the alert, touch button Silence/Acknowledge Alarm - or - Touch the Alert Status The alert is silenced/acknowledged and the silenced/acknowledged symbol and countdown will be displayed. Silenced/Acknowledged symbol and countdown Note: When an alert condition (of any severity) resolves itself before the clinician is able to respond, the alert condition will no longer be annunciated.

  • Page 93: Managing Alarm Annunciations

    When paused, the words ALARMS PAUSED appear at the top of the screen and an ALARMS PAUSED icon appears in the lower right corner of the screen. Alarms are paused Remaining “Paused” duration Note: When the clinician logs out of the ViSi Mobile Monitor, the alarms will automatically be resumed.

  • Page 94: To Resume Alarms

    Managing Alarm Annunciations To Resume Alarms When alarms are paused, the annunciation of any existing and new alarm will be disabled at both the ViSi Mobile Monitor and Remote Viewer. Alarms may be resumed from either the Mobile Monitor or Remote Viewer.

  • Page 95: Turn Alarm Annunciation On / Off

    Managing Alarm Annunciations 6.5.2 Turn Alarm Annunciation On / Off When alarms are turned OFF, there is no notification of a potentially clinically significant change in the patient's vital signs. Observe the patient by other means when alarm limits are set to OFF. To turn all alarms off 1.

  • Page 96: To Turn On Alarm Annunciation

    To Turn On Alarm Annunciation When alarms are turned off, the annunciation of any existing and new alarm will be disabled at both the ViSi Mobile Monitor and Remote Viewer. Alarms may be turned back on directly from the Monitor and Remote Viewer.
  • Page 97 To turn the alarm annunciation back on, touch the button. Turn Alarms On - or - Touch the Alarm Status The alarms will be turned back on. Note: Alarm annunciation will be turned on at both the ViSi Mobile Monitor and Remote Viewer.

  • Page 98: Manage Alarm Limits

    The Auto Set function only sets alarm limits for vital sign measurements that are currently in alarm. The new alarm limits are based on the current vital signs measurements. Once Auto Set is selected (on the ViSi Mobile Monitor), review the newly calculated alarm limits carefully before deciding to confirm or cancel the new alarm limits.
  • Page 99 Manage Alarm Limits 3. Touch Auto Set The Confirm New Alarm Limits screen appears. Alarm limits for all vital sign measurements currently in alarm are recalculated based on the current vital signs measurements. NIBP Alarm Limits cNIBP Alarm Limits (Alarm limits in white) (Alarm limits in red) Note: Systolic, diastolic and MAP alarm limits for cNIBP appear in red when measuring NIBP continuously.
  • Page 100 There is no autoset associated with BP MAP vital sign measurements. Note: Individual alarm limits may only be manually set from the ViSi Mobile Remote Viewer and not from the ViSi Mobile Monitor. Auto Set recalculates all alarm limits for vital sign...
  • Page 101 Manage Alarm Limits Auto Set Alarm Limits (Heart Rate / Respiration)
  • Page 102 Manage Alarm Limits Auto Set Alarm Limits (Blood Pressure)

  • Page 103: Testing Alarms

    Manage Alarm Limits 6.6.1 Testing Alarms Whenever a sensor is connected to the Monitor, a self-test of that sensor is initiated automatically to verify the sensor is in good working order. If the sensor and Monitor speaker are in good working order, you will hear a double beep.

  • Page 104: Battery Too Hot Alarms

    Return the Monitor and Chest Sensor to Sotera Wireless, Inc. Note: If the battery in the ViSi Mobile Monitor exceeds the defined safety limits while it is in the Charger, remove the Monitor from the Charger and allow the Monitor to cool down.

  • Page 105: Cuff Module Battery Temp (Cuff Too Hot)

    Cuff Battery Temp defined safety limits. Remove the ViSi Mobile Cuff Module from the patient immediately and allow it to cool down. Do not put the Cuff Module into the Battery Charger until it has cooled down. Return the Cuff Module to Sotera Wireless, Inc.
  • Page 106 Battery Too Hot Alarms - Notes -...

  • Page 107: Chapter 7. User/Preventative Maintenance

    7. User/Preventative Maintenance 7.1 Introduction This section of the manual outlines routine maintenance that should be performed by the user. The ViSi Mobile Monitoring System is designed for stable operation over long periods of time and, under normal circumstances, should not require technical maintenance beyond that described in this section.

  • Page 108: Cleaning And Disinfection

    Cleaning and Disinfection 7.3 Cleaning and Disinfection The ViSi Mobile Monitor, Cuff Module, Chest Sensor, Thumb Sensor, and Power Pack require cleaning and disinfection prior to reuse on a different patient. To prevent possible cross-contamination, properly clean and/or disinfect all ViSi Mobile reusable components between patients.

  • Page 109: Prior To Cleaning And Disinfecting

    Thumb Sensor from the Thumb Wrap. 3. When cleaning the optional ViSi Power Pack, first remove the Power Pack from the Power Pack Cradle. All components of the ViSi Power Pack should be cleaned and disinfected between uses.

  • Page 110: To Clean The Visi Mobile Monitoring System Components

    ViSi Mobile Monitoring System components. Do not autoclave the ViSi Mobile Monitor, its components, or accessories. Do not use excessive amounts of liquid when cleaning the ViSi Mobile Chest Sensor CableChest Sensor or the ViSi Mobile Thumb Sensor. To disinfect the ViSi Mobile Monitoring System components: 1.

  • Page 111: Inspecting Equipment And Accessories

    NOT be determined from patient simulators since they cannot duplicate human physiology. The only way to determine accuracy is to compare the ViSi reading against a blood gas value. When troubleshooting in a clinical setting, first inspect the sensor for proper placement as shown in this User Manual.

  • Page 112: Visi Mobile Monitoring System Battery Replacement

    Inspecting Equipment and Accessories 7.4.6 ViSi Mobile Monitoring System Battery Replacement Within the ViSi Mobile Monitor, Cuff Module, and Power Pack, the battery is sealed. The battery technology is closely integrated with safety circuits and software to protect from hazardous and harmful conditions.

  • Page 113: Product Disposal

    Handle and dispose of these items according to your facility’s policies. Disposables from the ViSi Disposable Kit should be disposed of per your facility’s procedures for bio- hazard materials. Contact the Sotera Wireless, Inc. Customer Service Department or the Sotera Wireless, Inc. representative in your area to obtain additional information about cleaning and disinfecting the ViSi Mobile Monitoring System components or product disposal.
  • Page 114 Product Disposal...

  • Page 115: Chapter 8. Patient Monitoring

    8. Patient Monitoring 8.1 Introduction The ability to monitor patients with a patient-worn ViSi Mobile Monitoring System opens up many opportunities to assess vital signs during all phases and activities involved in a patient’s recovery process. RESP (chest wall motion) can continue in the absence of ventilation (obstructed airway).

  • Page 116: Securing The Monitor

    Securing the Monitor 8.2 Securing the Monitor 8.2.1 Locking the Monitor When you have finished working with the Monitor, you should lock the Monitor to prevent the patient from accidentally accessing clinical settings. To lock the Monitor 1. When you are finished interacting with the patient and the Monitor, touch Lock The Vital Signs screen is locked to prevent settings from being inadvertently changed.
  • Page 117 Securing the Monitor 2. Touch in the lower left corner of the screen. Unlock The Enter PIN Code screen appears. Message area Return to previous screen Enter PIN code on the PIN code pad. As PIN digits are entered, a white dot appears in the message area for each digit entered and the Return to Previous Screen button changes to a Cancel button.

  • Page 118: Patient Monitoring

    Patient Monitoring 8.3 Patient Monitoring 8.3.1 Viewing Vital Signs Vital signs monitoring, with alarms, starts as soon as a sensor is connected to the patient and plugged into the Monitor. When there has been no interaction with the Monitor for a period of time, the display goes into Quiet Monitoring To view vital signs...

  • Page 119: Viewing Waveforms Associated With Vital Signs

    Patient Monitoring 8.3.2 Viewing Waveforms Associated with Vital Signs Waveforms move across the display from left to right. A sweep bar erases the oldest waveform and replaces it with the newest waveform as it moves from left to right. Sweep Pacer Spike The speed of the waveform display (sweep speed) is scaled to 25 mm/sec for ECG, and SpO...

  • Page 120: To View Other Leads With The Chest Sensor Cablechest Sensor

    Patient Monitoring To view other leads with the Chest Sensor 1. Touch ECG Lead Selection or the waveform The lower part of the display is replaced with Lead Selection buttons. 2. Select the lead corresponding to the waveform that you want to view. All available leads can be viewed one at time from this view.
  • Page 121 Input Overload / Dynamic Range The ViSi Mobile Monitor display indicates an input overload condition (i.e. the input dynamic range of the amplifier associated with the displayed ECG lead has been exceeded) by displaying the trace in red at the top (or bottom) of the ECG waveform display area.

  • Page 122: To View The Resp Waveform

    Patient Monitoring To view the RESP waveform 1. Touch the numeric. RESP The top third of the display is replaced with the RESP waveform. 2. To return to the main screen, touch the numeric. Vital Signs RESP The RESP waveform is no longer displayed. To view the SpO waveform 1.

  • Page 123: Motion Artifact

    Patient Monitoring 8.3.3 Motion Artifact If a vital sign cannot be measured due to a motion artifact, the word “MOTION” displays below the vital sign name, and “xx” is displayed in place of the numeric(s). See SpO below.

  • Page 124: Setting Up/Taking Nibp Measurements

    The ViSi Mobile Disposable Cuff should be snug enough to support the Cuff Module while not impairing circulation when deflated. Avoid touching the ViSi Mobile Disposable Cuff during cuff inflation as it may disrupt the measurement. Note: The ViSi Mobile Cuff Module cannot be used with the auscultatory method of measuring NIBP.

  • Page 125: Selecting Blood Pressure Mode

    Setting Up/Taking NIBP Measurements 8.4.1 Selecting Blood Pressure Mode Note: The Monitor will automatically default to a NIBP mode depending on which sensors are connected. You only need to select a NIBP mode if you want to change the default. To select the blood pressure mode 1.

  • Page 126: Taking A Nibp Measurement

    Store the Cuff and Cuff Module in a convenient location. To take a single NIBP measurement 1. Apply the Cuff and Cuff Module. See Applying the ViSi Mobile Cuff Module and Disposable Cuff on page 75. After the Cuff Module has been connected to the Monitor, the NIBP vital sign numerics (Systolic, Diastolic and MAP) display as “xx”, indicating no measurement has been taken.
  • Page 127 Setting Up/Taking NIBP Measurements Upon completion of a successful measurement, the Systolic, Diastolic and MAP measurements are displayed in white. The time of the measurement is displayed below the NIBP label. If there is no other heart rate/pulse rate source (i.e. Thumb Sensor or Chest Sensor are not connected to the Monitor), then a one-time PR from the NIBP measurement is displayed for 30 seconds.

  • Page 128: To Stop An Nibp Measurement

    Setting Up/Taking NIBP Measurements To stop an NIBP measurement An NIBP measurement currently in progress may be stopped at any time. Inflation Pressure (mmHg) Stop Cuff Inflation Pressure Indicator Bar Touch to stop the cuff inflation and NIBP measurement. Stop NIBP The cuff will deflate.

  • Page 129: Initiating Automatic Nibp Measurements

    To initiate automatic NIBP measurements 1. Apply the Cuff and Cuff Module, if not already on the patient. See Applying the ViSi Mobile Cuff Module and Disposable Cuff on page 75. 2. Set the , if the mode is not already Automatic.

  • Page 130: Calibrating Continuous Nibp Monitoring

    Setting Up/Taking NIBP Measurements 8.4.4 Calibrating Continuous NIBP Monitoring Sotera’s continuous blood pressure monitor (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.

  • Page 131: To Calibrate Nibp For Continuous Monitoring

    (Calibrate cNIBP Reading Displayed yet been met button enabled) 1. Connect the ViSi Mobile Chest Sensor, Thumb Sensor and Cuff Module and navigate to the Vitals screen. Signs Note: Have the patient positioned in a supine, semi-Fowler’s, or side-lying position during cNIBP calibration.

  • Page 132: To Stop The Cnibp Calibration

    Note: The accuracy of cNIBP measurements have not been confirmed when the posture is greater than a semi-Fowler’s position of 30 degrees. 3. Remove the Cuff from the patient and the ViSi Mobile Cuff Module from the Monitor. The continuous measurements will continue to display/update even after the cuff has been disconnected.

  • Page 133: To Recalibrate Cnibp

    To manually recalibrate cNIBP, following the steps outlined in section To calibrate NIBP for continuous monitoring on page 129. Note: When a recalibration event is detected, the ViSi Mobile Monitor will display the Calibrate cNIBP alert. Connect the Cuff Module, if not already connected, and recalibrate manually.

  • Page 134: Patient's Posture

    Patient’s Posture 8.5 Patient’s Posture Note: When cNIBP is initiated for the first time, the Posture Selection screen will automatically display before calibration starts. The patient’s posture must be selected and confirmed before cNIBP can be calibrated. See Calibrating Continuous NIBP Monitoring on page 128. To View the Patient’s Posture 1.
  • Page 135 Patient’s Posture 4. Touch to confirm the selected posture is correct. Confirm The Confirm button will be disabled until a posture has been selected. - or - Touch Cancel If cancelled, the selected posture will be discarded and the Select Patient’s Posture screen will be closed.

  • Page 136: Viewing Patient's Demographics

    8.6 Viewing Patient’s Demographics To Confirm Patient’s Demographics When the patient’s demographics have been changed on the ViSi Mobile Remote Viewer or there is an interruption of monitoring of more than 30 seconds, the demographics must be confirmed (or rejected) directly on the ViSi Mobile Monitor.

  • Page 137: To View Patient's Demographics

    Patient Information Menu Patient Information The Patient Information screen is displayed. Note: The patient’s demographics are entered on the ViSi Mobile Remote Viewer. The patient’s posture will be displayed on this screen. See Patient’s Posture on page 132.

  • Page 138: Exchanging A Monitor With Low Battery

    8.7 Exchanging a Monitor With Low Battery To exchange a monitor with a low battery When the ViSi Mobile Monitor’s battery becomes low during monitoring, it may be exchanged with a new Monitor without stopping the patient’s monitoring session. Note: You will not be able to exchange the monitoring using the method described below if the monitor’s battery is too low to monitor.
  • Page 139 Monitor has connected to the network. Note: The two Monitors must be double-bumped together such that the long ends of the Monitors make contact with each other. See the image on the ViSi Mobile Monitor Instructions screen above.
  • Page 140 Exchanging a Monitor With Low Battery 3. Double bump the new Monitor with the Monitor on the patient’s wrist. - or - Touch Cancel If cancelled, the Device Swap will automatically be cancelled. If the monitors are successfully double bumped, the Exchange process will be initiated. The new Monitor will display the Waiting Patient Transfer screen and the patient’s Monitor will display the Confirm Device Swap screen.

  • Page 141: Pause Monitoring

    Pause Monitoring Instructions Clean Monitor (Patient’s New Monitor) (Patient’s Old Monitor) Note: If the clinician has not already authenticated on the patient’s current monitor before the device exchange is initiated, the clinician will be prompted to authenticate before the Clean Monitor screen is displayed.

  • Page 142: To Pause Monitoring

    Pause Monitoring To pause monitoring 1. With one finger, touch the Monitor screen for two seconds to activate the display. The Patient View screen appears. 2. Enter your PIN code if required. (See To unlock the Monitor on page 114.) The Vital Signs screen appears.
  • Page 143 142. When monitoring has been paused, monitoring may only be resumed using the same ViSi Mobile Monitor. If you place the ViSi Mobile Monitor into the Charger with other Monitors, label the Monitor so that is can be identified...

  • Page 144: Stop Monitoring

    Stop Monitoring 8.9 Stop Monitoring Stop monitoring when ALL vital signs monitoring is no longer required. To stop monitoring 1. With one finger, touch the Monitor screen for two seconds to activate the display. The Patient View screen appears. 2. Enter your PIN code if required. (See To unlock the Monitor on page 114.) The Vital Signs screen appears.

  • Page 145: To Clean And Prepare Reusable Components

    See section 7. User/Preventative Maintenance on page 105. 2. Place the cleaned Monitor and Cuff Module into the Charger. Never place the ViSi Mobile Monitor, the ViSi Mobile Cuff Module, or the ViSi Power Pack into the ViSi Mobile Charger while connected to a patient.
  • Page 146 Stop Monitoring If the ViSi Power Pack beeper/buzzer sounds or the Red LED is permanently lit, the ViSi Power Pack should be disconnected from the patient immediately.

  • Page 147: All Sensors Disconnected

    The “All Sensors Disconnected” screen will be displayed when the last sensor is disconnected from the ViSi Mobile Monitor without going through the proper “Stop Monitoring” procedure. (see 8.6Viewing Patient’s Demographics on 134). An “All Disconnected” alert will be generated.

  • Page 148: Disable Skin Temperature

    Disable Skin Temperature 8.11 Disable Skin Temperature In the event that a Facility’s Care Unit chooses to not monitor the Skin Temperature vital sign, that feature can be turned off through the Facility’s Care Unit .XML configuration file that is pushed from the server. Note: Only while in Bio Med Mode is it possible to turn the Skin Temperature vital sign “On”...

  • Page 149: Chapter 9. Troubleshooting

    9. Troubleshooting 9.1 Introduction The ViSi Mobile Monitoring System is designed to alert the clinician to technical issues that may occur while monitoring a patient’s vital signs. The following tables provide troubleshooting solutions to potential problems that may be encountered while monitoring a patient.

  • Page 150: Visi Mobile Monitor

    ViSi Mobile Monitor 9.2 ViSi Mobile Monitor Problem Potential Cause Solution The screen is blank The display is in Quiet Touch the screen with one finger for two Monitoring Mode. seconds to activate display. Plug in a sensor to initiate monitoring.

  • Page 151: Visi Mobile Chest Sensor Cablechest Sensor

    • Remind the patient that this is a med- ical device, and that tampering may result in missing important clinical events. 9.3 ViSi Mobile Chest Sensor Problem Potential Cause Solution Chest Sensor is too short to plug Monitor is oriented in the wrong...
  • Page 152 ViSi Mobile Chest Sensor Problem Potential Cause Solution HR is erratic ECG electrodes are not all the Use all the same ECG electrode type, same. size, materials, and manufacturer. ECG electrode gel is dry. Replace ECG electrodes. ECG electrodes not firmly Check that the ECG electrodes are attached to the patient’s chest.
  • Page 153 ViSi Mobile Chest Sensor Problem Potential Cause Solution No SKIN temperature numeric The Chest Module sensor is Place the Chest Module sensor on the placed on the patient with the patient such that the Temperature Sensor Temperature Sensor facing away is in direct contact with the patient’s...

  • Page 154: Visi Mobile Thumb Sensor

    ViSi Mobile Thumb Sensor 9.4 ViSi Mobile Thumb Sensor Problem Potential Cause Solution Thumb Sensor cable too short to Monitor is oriented in the wrong Make sure that the rounded end of the Plug into Monitor direction. Monitor is oriented towards the hand.

  • Page 155: Visi Mobile Cuff Module

    ViSi Mobile Cuff Module 9.5 ViSi Mobile Cuff Module Problem Potential Cause Solution Cuff Module cable is too short to Monitor is oriented in the wrong Make sure that the flat end of the Monitor Plug into Monitor direction. is oriented towards the arm.
  • Page 156 Remove Cuff Module from the Char- red when in the Charger. expectation. ger. • Report the problem to Sotera Wire- less, Inc. Customer Service Depart- ment or the Sotera Wireless, Inc. representative in your area. Current level has exceeded •...

  • Page 157: Visi Mobile Battery Charger

    ViSi Mobile Battery Charger 9.6 ViSi Mobile Battery Charger Problem Potential Cause Solution Batteries in the Monitor, Cuff The Monitor and Cuff Module Make sure that the Monitor, Cuff Module, or optional Power are not securely seated in the Module, and Power Pack are securely Packdo not charge Charger.

  • Page 158: Visi Power Pack (Optional Accessory)

    ViSi Power Pack (Optional Accessory) 9.7 ViSi Power Pack (Optional Accessory) Problem Potential Cause Solution Power Pack Does Not Beep Power Pack battery is too low Disconnect from ViSi Monitor, replace when plugged into Monitor Power Pack and place depleted Power...

  • Page 159: General Troubleshooting

    Area. 9.8.2 Alarms and Alerts When testing the speaker at the ViSi Mobile Remote Viewer, you are testing how the alarm and alert tones will sound at the Remote Viewer during typical operation. If the volume is inadequate, clinicians could miss alarms and alerts.
  • Page 160 The audio tone never permanently. returns. At the ViSi Mobile Monitor, I set all alarming to OFF, or Some important alarms and alerts (such as sensor I set all alarming to PAUSED. But some alarms and being disconnected) will continue to annunciate even alerts continue to be annunciated.

  • Page 161: Visi Mobile Remote Viewer

    Upper and lower limits for a vital sign cannot be the same value. The alarm limits on the ViSi Mobile Monitor and the The alarm limits were set on the ViSi Mobile Monitor limits at the ViSi Mobile Remote Viewer do not match.
  • Page 162 ViSi Mobile Remote Viewer...

  • Page 163: Chapter 10. Specifications

    Do not use the ViSi Mobile Monitoring System in neonatal or pediatric patients (under the age of 18 years) since the System has not been evaluated for these patient groups.Do not use the ViSi Mobile Monitor as a primary hypoxia diagnostic tool.

  • Page 164: Vital Sign Measurements

    Vital Sign Measurements 10.2 Vital Sign Measurements 10.2.1 Heart Rate Heart Rate Display Range 0 to 240 BPM Accuracy Range 30 to 240 BPM Accuracy ±3 BPM Resolution 1 BPM Pacemaker • The monitor detects and rejects pacemaker impulses in accordance with ANSI/AAMI/IEC 60601-2-27:2011 - •...
  • Page 165 Vital Sign Measurements Heart Rate Pacemaker Pulse Rejection Tested per ANSI/AAMI/IEC 60601-2-27:2011 , 201.12.1.101.13, Method A: With Overshoot Pulse Rejection Range: Amplitude from ±2 mV to ±700 mV Pulse Width from 0.1 ms to 2 ms Note: Pulses with polarization overshoot >...
  • Page 166 Vital Sign Measurements Heart Rate Time to Alarm for High Tested per ANSI/AAMI/IEC 60601-2-27:2011 , 208.6.6.2.103: Heart Rate • < 15 seconds Time to Alarm for Tested per ANSI/AAMI/IEC 60601-2-27:2011 , 201.7.9.2.9.101, b) 6): Tachycardia Figure 4a: • 12 seconds •...

  • Page 167: Respiration

    Vital Sign Measurements 10.2.2 Respiration Respiration Method Impedance Pneumography Display Range 0 to 50 BR/MIN Accuracy Range 3 to 50 BR/MIN Accuracy ± 3 BR/MIN or 10% of reading, whichever is greater Resolution 1 BR/MIN Respiration Drive Voltage: 1.00 V P-P ±5% Frequency: 32.0 KHz ±2%...

  • Page 168: Pulse Oximetry (Spo2, Functional Oxygen Saturation)

    CO-Oximeter (see Bland-Altman: ViSi Mobile Pulse Oximetry table). Note: A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter monitor.
  • Page 169 Vital Sign Measurements The table below shows A values measured using the ViSi Mobile Thumb Sensor (Model 92-10020) with the ViSi Mobile Monitoring System in a clinical study: Validation Data (per ISO 9919) Age of Volunteers 18 - 45 Accuracy (No Motion)

  • Page 170: Non-Invasive Blood Pressure (Nibp)

    Vital Sign Measurements 10.2.4 Non-Invasive Blood Pressure (NIBP) Non-Invasive Blood Pressure (NIBP) Normative Reference ISO 81060-2: Non-invasive Sphygmomanometers - Part 2: Clinical validation of automated measurement type. Principle of Operation Oscillometry Systolic Range: 60 to 240 mmHg Accuracy: Mean error of less than ± 5 mmHg and a std. dev. of ≤ 8 mmHg Resolution: 1 mmHg Diastolic...
  • Page 171 Vital Sign Measurements Diastolic Bland Altman Analysis (NIBP) Sample Size: 152 data points Mean: -1.49 mmHg Standard Deviation: 3.22 mmHg Upper 95% Limits of Agreement (+1.96 SD): 4.8 mmHg Lower 95% Limits of Agreement (-1.96 SD): -7.8 mmHg Mean Arterial Pressure Bland Altman Analysis (NIBP) Sample Size: 152 data points Mean:...

  • Page 172: Continuous Non-Invasive Blood Pressure (Cnibp)

    Subject age range: 19-48 years Arm circumference range tested: 21-38 cm 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.
  • Page 173 Vital Sign Measurements Changes in posture and arm height can affect ViSi cNIBP accuracy. If the cNIBP measurement is questionable, retake the measurement. Ideally recalibrate in the same position as the initial calibration. Systolic Bland Altman Analysis (cNIBP) Sample Size:...
  • Page 174 Vital Sign Measurements Standard Deviation: 3.62 mmHg Upper 95% Limits of Agreement (+1.96 SD): 5.4 mmHg Upper 95% Limits of Agreement (-1.96 SD): -8.7 mmHg MAP Bland Altman Analysis Sample Size: 54,179 data points Mean: -0.67 mmHg Standard Deviation: 3.86 mmHg Upper 95% Limits of Agreement (+1.96 SD): 6.9 mmHg Upper 95% Limits of Agreement (-1.96 SD):...

  • Page 175: Skin Temperature

    Vital Sign Measurements 10.2.6 Skin Temperature Temperature Scale Range / Accuracy Range Accuracy Range Accuracy (measurement at - 19.9 ±0.3 - 67.9 ±0.5 approximately 102 kPa / 768 mmHg) - 24.9 ±0.3 - 76.9 ±0.5 - 35.9 ±0.2 - 96.7 ±0.3 - 39.9 ±0.1...

  • Page 176: Physical Components

    Physical Components 10.3 Physical Components 10.3.1 ViSi Mobile Monitor ViSi Mobile Monitor Physical 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. L exclusive of connectors and Wrist Cradle Weight 110 g / 3.92 oz...

  • Page 177: Mode Plugs

    Physical Components Other RF radiating devices (such as high powered RFID readers and Bluetooth devices) that are in close proximity with the ViSi Mobile Monitor may interfere with the Monitor’s wireless communications. During such interference, the Monitor continues to monitor and will alarm locally. If wireless communication is affected when using the Monitor in close proximity with another RF radiating device, move the other device away from the Monitor or discontinue use of the other device.If you have any...

  • Page 178: Visi Mobile Chest Sensor Cablechest Sensor

    Physical Components Chest Sensor 10.3.2 ViSi Mobile ViSi Mobile Chest Sensor Mechanical Complies with EC53 Weight 72 g / 62 g (2.54 oz. / 2.19 oz.) (5 lead-wire / 3 lead-wire) Operating Temperature 0 - 40 C / 32 F - 104...

  • Page 179: Visi Mobile Cuff Module

    Cleaning / Disinfecting Liquid Ingress Rating IPX0 Isopropyl alcohol (IPA) Solutions / Compounds • • Detergent (Alconox) When the ViSi Mobile Cuff Module is connected to the other ViSi Mobile Components, the entire system has an ingress protection rating of IPX0.

  • Page 180: Visi Mobile Thumb Sensor

    Physical Components 10.3.4 ViSi Mobile Thumb Sensor ViSi Mobile Thumb Sensor Cleaning / Disinfecting Liquid Ingress Rating IPX7 During cleaning cycle only, not during monitoring Isopropyl alcohol (IPA) Solutions / Compounds • • Detergent (Alconox)

  • Page 181: Visi Mobile Charger - 8 Bay

    Physical Components 10.3.5 ViSi Mobile Charger - 8 Bay ViSi Mobile Charger Physical 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...

  • Page 182: Visi Mobile Power Pack (Optional Accessory)

    Physical Components 10.3.7 ViSi Mobile Power Pack (Optional Accessory) ViSi Power Pack Physical Characteristics Dimensions 3.13 cm H x 4.87 cm W x 12.19 cm L (1.23 in. H x 1.91 in. W x 4.80 in. L) Cable Length 3 to 5 ft.

  • Page 183: Visi Mobile Appliance

    (Full System) Power recommended. In the ViSi Mobile Monitoring System, data is captured in the ViSi Mobile Appliance, which acts as an enterprise hub. The Appliance is dedicated hardware installed in the IT datacenter for secure network connectivity and emergency power backup. For more information on the ViSi Mobile Appliance, see the...

  • Page 184: Visi Mobile Remote Viewer

    Windows platforms. Anti-virus software is not installed on the ViSi Mobile Monitor. Note: For printing capability, Sotera Wireless, Inc. recommends connecting a printer directly to the ViSi Mobile Remote Viewer or to an in-network printer via an IP address. Sotera Wireless, Inc. does not support additional configurations.

  • Page 185: Customer Network

    Physical Components 10.3.10 Customer Network Wireless Network Wireless Network Standard IEEE 802.11b/g/n Recommended Channels 1, 6, 11 Network Latency < 150 ms Wireless Network Security Support WPA2-PSK Minimum Receiver Sensitivity -65 dBm (edge coverage) Wireless access point cell overlap 15-20% 25 dB Signal-to-Noise Ratio 6%...

  • Page 186: Alarms / Alerts Annunciation

    Alarms / Alerts Annunciation 10.4 Alarms / Alerts Annunciation Note: An “Annunciation Delay” is the time that an alarm system deliberately delays the alarm annunciation (audibly and visually) to ensure clinical relevance of the detected alarming condition. Within the tables below, see column “Annunciation Delay” for the pre-defined periods of time.
  • Page 187 Alarms / Alerts Annunciation a. When measuring blood pressure as a 1-time measurement or at automatic intervals, there will be no annunciation delay.
  • Page 188 Alarms / Alerts Annunciation Battery Alarms No Pulse Detected Alarms Limit Annunciation Delay When Thumb Sensor is primary source No Pulse No delay When Cuff Module is primary source No Pulse No delay Battery Alarms Limit Annunciation Delay Monitoring Mode No delay C (113 In the Charger...

  • Page 189: Equipment Alarms (Alerts)

    Alarms / Alerts Annunciation 10.4.2 Equipment Alarms (Alerts) Visual Display The following table outlines the visual display when alerts are in progress: Severity Indicator Attributes Toggle / Flash Speed Duty Cycle All Severities Cyan (Blue) Constant (ON) 100% ON Audio Tones The following table outlines the audio tones when alerts are in progress: Frequency Duration...
  • Page 190 Shock Hazard No delay Patient Tampering 5 invalid pin codes No delay (number of incorrect pin code entries) Description of Annunciation Delay ViSi Power Pack Alerts Audible Alert Annunciation (in seconds) Power Pack Connected 1 Beep No delay Power Pack Disconnected...

  • Page 191: Environmental Conditions

    Range 803 mmHg to 375 mmHg 803 mmHg to 525 mmHg 1.06 atm to 0.49 atm 1.06 atm to 0.69 atm The ViSi Mobile Monitoring System may not perform to specification if stored or shipped outside the specified temperature range.

  • Page 192: Compliances

    Changes or modifications not expressly approved by Sotera Wireless, Inc. could void the user’s authority to operate the equipment. Manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment.

  • Page 193: Electromagnetic Compatibility (Emc) Specifications

    Mobile Monitoring System or Power Pack. Accessories Compliant with EMC Standards All accessories (e.g. ViSi Mobile Charger) comply with either IEC 60601-1-2 or IEC 60950-1. Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the...

  • Page 194: Electromagnetic Emissions

    The battery operated ViSi Mobile Monitor contains a 2.4 GHz DSSS transmitter for the purpose of wire- less communication. The radio is excluded from the EMC requirements of IEC 60601-1-2, but should be...

  • Page 195: Electromagnetic Immunity

    Compliances 10.6.4 Electromagnetic Immunity The ViSi Mobile Monitor is suitable for use in specified electromagnetic environments. The user must ensure that it is used in the appropriate environment as described below. IEC 60601-1-2 Electromagnetic Immunity Test Environment Guidance Test Level...

  • Page 196: Recommended Separation Distance

    6 feet of the ViSi Mobile Monitor. Portable and mobile RF communications equipment should be used no closer to any part of the ViSi Mobile Monitor, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter.

  • Page 197: From Portable And Mobile Rf Communication Equipment

    From Portable and Mobile RF Communication Equipment The ViSi Mobile Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Monitor can help prevent electromagnetic...

  • Page 198: Standards

    Compliances 10.6.6 Standards Agency Compliances • CAN/CSA C22.2 No 60601-1, Part 1: General requirements for basic safety and essential performance • IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for safety (EN 60601- 1:2006) • IEC 60601-1-2:2007, Med. Elect. Equipment – Part 1-2: General requirements for safety – Collateral stan- dard: EMC –...

  • Page 199: Wireless Network Risk Mitigation

    ViSi Mobile Monitors connected to patients and the ViSi Appliance. Physiologic data and alarms originating from the ViSi Mobile Monitors are transmitted over the IT network to the ViSi Mobile Remote Viewer where supplemental alarm notification occurs. Reliability of the IT network is essential in ensuring the supplementary alarm notification meets the intended use.
  • Page 200 Notify Sotera Wireless, Inc. prior to making modifications to the network, including configuration changes that could potentially compromise the IT Network as verified at the initial installation of the ViSi System. For support contact Sotera Wireless, Inc. or an authorized Sotera Wireless, Inc. representative in your area.

  • Page 201: Appendix A. Alarm Summary

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

  • Page 202: High Alarms

    Patient Alarms High Alarms Display Message Alarm Summary Cause THUMB NO PULSE Module - No Pulse Unable to detect a pulse from the Thumb Sensor. Thumb Sensor is the primary source of PR. Detected CUFF NO PULSE Cuff Module - No Pulse Chest Sensor and Thumb Sensor are not connected.

  • Page 203: Equipment Alerts

    Equipment Alerts Equipment Alerts ViSi Mobile Monitor Alerts Display Message Symbol(s) Severity Cause Solution AUDIO FAILURE Either the microphone or Stop monitoring and replace the speaker on the Monitor the Monitor. has failed. Return the Monitor to Sotera Wireless, Inc.

  • Page 204: Visi Mobile Chest Sensor Cablechest Sensor And Ecg Alerts

    Equipment Alerts ViSi Mobile Chest Sensor and ECG Alerts Display Message Severity Cause Solution CHEST SENSOR The Chest Sensor is Acknowledge the alert and remove disconnected from the Monitor the Chest Sensor from the patient, or and not yet acknowledged by the reconnect the Chest Sensor to the clinician.

  • Page 205: Visi Mobile Thumb Sensor And Spo2 Alerts

    THUMB SENSOR The optical signal has been lost. Reposition the Thumb Sensor at the base of the patient’s thumb. Replace the Thumb Sensor. ViSi Mobile Cuff Module and NIBP Alerts Display Message Severity Cause Solution CHECK CUFF...

  • Page 206: Visi Power Pack Alerts

    No measurements are that has a full battery charge. possible. ViSi Power Pack Alerts Note: In the event of a Power Pack malfunction while it is connected to a ViSi Mobile Monitor, the Monitor will indicate “Battery Pack Fault”. Display Message Severity...

  • Page 207: Miscellaneous Alerts

    Remove the Cuff Module from HAZARD placed in the Charger while the Charger or disconnect the still connected to the Cuff Module from the Monitor. Monitor. ViSi Mobile Charging Alerts Display Message Severity Cause Solution CHARGE CURRENT High Monitor charging over current...

  • Page 208: Visi Mobile Monitor Status Icons

    Connectivity between the ViSi Monitor and the Appliance is good. The number of green bars indicates 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.

  • Page 209: Appendix B. Visi Power Pack

    Intended Use The ViSi Power Pack is intended to be used by clinicians and medically qualified personnel only and is used in conjunction with the ViSi Mobile Monitor. The ViSi Power Pack's only purpose is to extend...

  • Page 210: Warnings And Cautions

    ViSi Power Pack. Note: The ViSi Power Pack is only designed to sustain the battery life of the internal ViSi Mobile Monitor battery; it will not recharge the battery. When the ViSi Power Pack is disconnected, the ViSi Mobile Monitor battery charge level is not expected to have increased.

  • Page 211: General Description

    The ViSi Power Pack is a portable, battery operated power source that is used with the ViSi Mobile Monitor. The ViSi Power Pack is not intended to be worn by the patient. It comes with a ViSi Power Pack Cradle which only acts as a base for the Power Pack when in use and contains no electrical components.

  • Page 212: Visi Power Pack Cradle

    General Description The Power Pack and has a cable that connects to the flat side of the ViSi Mobile Monitor when the Monitor is in its Wrist Cradle. In addition to battery power, the cable also provides information on temperature, voltage and current to the Monitor which will show a alert in case of failure.

  • Page 213: Operation

    Pole Mount ViSi Power Pack (Optional) Seat The ViSi Power Pack cradle comes with an optional pole mount that attaches to a bedside or IV pole for greater stability or mobility for the patient. Operation Inspecting the Equipment Before using the ViSi Power Pack, visually inspect each component of the ViSi Mobile Monitoring System and Power Pack.

  • Page 214: Checking The Battery Charge Of The Visi Power Pack

    ViSi Power Pack. Battery Status There is a row of eight colored lights (Battery Status Indator LEDs) on the front surface of the ViSi Power Pack. Illuminated lights indicate the level of the battery charge: •...
  • Page 215 ViSi Mobile Charger. The ViSi Mobile Charger provided by Sotera Wireless, Inc. is the required Charger for ViSi Power Pack. The Charger is capable of charging up to eight of any combination of Power Packs, To charge the Power Pack, place the flat end into one of the slots with the front facing outwards.
  • Page 216 Note: The ViSi Mobile Charger is to be used for ViSi Mobile components only. Note: ViSi Mobile Power Packs contain sealed batteries that are not replaceable by the user. If a Power Pack has a battery issue, contact the Sotera Wireless, Inc. Customer Service...
  • Page 217 General Description Setting up the ViSi Power Pack Cradle The ViSi Power Pack Cradle can either be placed on a sturdy horizontal surface or can be attached to a pole or bedframe with the optional pole mount. To use the pole mount: 1.

  • Page 218: Using The Visi Power Pack

    Insert with connectors contacts facing upwards The ViSi Power Pack and the Monitor will make a beeping noise to indicate that the Power Pack is connected. Once connected, the Power Pack will automatically begin to provide auxilliary power to the Monitor.

  • Page 219: Replacing The Visi Power Pack

    General Description When not in use, disconnect the ViSi Power Pack from the Monitor. It is recommended to place the ViSi Power Pack in the ViSi Mobile Charger (see section ViSi Mobile Charger on page 40) between uses. Replacing the ViSi Power Pack...

  • Page 220: Equipment Alerts

    Equipment Alerts Equipment Alerts The ViSi Power Pack has technical alerts that are intended to notify the clinician of situations that may be hazardous or impede the ability of the Power Pack to provide power to the Monitor. Note: For a listing of these Alerts, please see Alarm Summary on page 199 Note: In the event of a Power Pack malfunction while it is connected to a ViSi Mobile Monitor, the Monitor will indicate “Battery Pack Fault”.

  • Page 221: Troubleshooting

    Troubleshooting - Notes -...
  • Page 222 Troubleshooting...

  • Page 223: Appendix C. Symbols

    Appendix C - Symbols Alarms / Alerts Alarm / Alert States Symbol Description Unacknowledged life threatening severity alarm in progress. Unacknowledged high severity alarm in progress Unacknowledged alert in progress (any severity). All alarms in progress have been acknowledged by the clinician. Alarm annunciation (visual and audio) has been paused for 2 minutes.
  • Page 224 Alarms / Alerts Symbol Description Resume alarm annunciation from a paused state. Turn alarm annunciation back on. Acknowledge an alarm/alert that is in progress.

  • Page 225: Battery States

    Charger. There is less than 10 minutes of battery charge left. ViSi Power Pack When the ViSi Power Pack is connected to a Monitor, the Monitor screen will show the battery level of the Power Pack. Battery Status Icon The battery in the Power Pack is charged.
  • Page 226 Battery States Battery Status Icon The battery in the Power Pack is critically low. Remaining battery level is <4% and too low to charge a Monitor.

  • Page 227: General Icons

    Vital sign measurement is below the lower display range. Navigation 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.

  • Page 228: Clinical Menu

    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”...
  • Page 229 General Icons Symbol Description 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. Monitor is ready to perform device swap.

  • Page 230: Patient's Postures

    Patient is lying on their right side. Patient is lying on their left side. a. When the ViSi Mobile Monitor has identified a Patient as walking for two consecutive updates, the cNIBP monitoring will be paused for a mininum of 30 seconds.

  • Page 231: Labelling

    Labelling Labelling Symbol Description Warning, refer to accompanying documents Caution, refer to accompanying documents WiFi Alliance certification Conforms with EEC directives Catalog number Serial Number Manufactured By Defibrillator proof type CF equipment This product is designated for separate collection at an appropriate collection point. Do not dispose of as household waste.
  • Page 232 Labelling Symbol Description CONT Contents MRI Unsafe Non-ionizing radiation Caution, refers to accompanying electronic document...
  • Page 233 Labelling - Notes -...
  • Page 234 Labelling...

  • Page 235: Appendix D. Warranty

    Appendix D - Warranty Warranty Sotera Wireless, Inc. warrants to End User, for a period of one (1) year from the date of delivery, unless otherwise noted in specific documentation, that the products sold by Sotera Wireless, Inc. will operate in accordance with Sotera Wireless, Inc.’s published documentation in effect on the date of delivery or Sotera...
  • Page 236 Sotera Wireless, Inc. Responsibility In no event shall Sotera Wireless, Inc. be liable to end user or any third parties for any consequential, incidental, indirect, exemplary, punitive, contingent, statutory or any other special damages. Sotera Wireless, Inc.’s liability for damages on account of a claimed defect in any product delivered by Sotera Wireless, Inc.
  • Page 237 Index Alarm Summary 199 Alarm Summary on page 195 219 Alarms 81 Alarms/Alerts Annunciation Rules 83 Managing Annunciations 84 Monitor Battery Too Hot 102, 103 Pause & Resume 91 Responding To 85, 89 Set Alarm Limits 96 Testing Annunciation 101 Turn Off (All Alarms) 93 Alerts Charging 205...
  • Page 238 Chest Sensor 109 Cuff Module 109 Exchange Monitor with Low Battery 136 In the event of a Power Pack malfunction while it is connected to a ViSi Mobile Monitor, the Mon- itor will indicate “Battery Pack Fault”. 219 Intended Use 12...
  • Page 239 Lock Monitor 114 Monitor Charging 42 Power Indicator 35, 60 Monitoring ECG/HR 47 Non-Invasive Blood Pressure (NIBP) 49 Pulse Oximetry 48 Respiration 47 Skin Temperature 48 Monitoring Setup Apply Chest Sensor Cable 72 Apply Thumb Sensor 66 Apply Wrist Cradle 64 Lock in the Monitor 65 Motion Artifacts 121 NIBP 122, 203...
  • Page 240 Power Pack 209 Alerts 219 Charging 212 Cradle 210, 215 Maintenance 219 Operation 211 Power Indicator 212 Replacing 217 Troubleshooting 219 Using with Monitor 216 Preventative Maintenance 105 Product Disposal 111 Remove Sensors (From Patient) 77 Specifications 161 Physical Components 174 2-Bay Charger 179 8-Bay Charger 179 Appliance 181...
  • Page 241 Connectivity Lost 157 Cuff Module 153 Monitor 148 Setting Alarm Limits (Remote Viewer) 159 Thumb Sensor 152 Unlock Monitor 114 ViSi Mobile Monitor 35 ViSi Power Pack 207 Vital Signs 116 Warnings 14 Warranty 233 Exclusions 233 Third Party Products 233...
  • Page 242 - Notes -...

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