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VitalConnect VitalPatch - User Manual

VitalConnect VitalPatch
17 pages
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CorVitals, Distributor
IFU-02 Rev. J Page ! of ! 1 17
DCO-M-1556|Date: 06Mar2018

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Summary

Device Description

Indications for Use

Contraindications

Warnings

Product Storage

System Interoperability

VitalPatch Usage and Handling

VitalPatch Overview

Details the orientation of the Logo and Battery sides of the VitalPatch device for correct patient placement.

Product Handling

Ensures hands are clean and dry before handling the VitalPatch device, recommending gloves for handling.

Skin Preparation and Application

Step 1: Prepare Skin

Prepare the application site on the upper left chest or below the sternum on the rib cage. Ensure the area is clean and dry.

Step 2: Remove VitalPatch from Pouch

Tear open the pouch carefully to remove the VitalPatch device without pressing the Power Button.

Step 3: Power-on VitalPatch

Press the Power Button and look for a temporary green light to confirm the device is powered on.

VitalPatch Removal and Disposal

Troubleshooting

Contact Information

Product Specifications

Measurements

Communications

Battery and Operating Conditions

Electromagnetic Emission Declaration

FCC Compliance

Canada License-exempt

Electromagnetic Immunity Guidance

Recommended Separation Distance

General Symbols

VitalConnect VitalPatch Specifications

General IconGeneral
Device TypeWearable biosensor patch
CategoryMedical Equipment
ConnectivityBluetooth Low Energy (BLE)
Water ResistanceIP67
FDA ClearedYes
CE MarkedYes
SensorsECG, accelerometer
Data CollectedHeart rate, respiratory rate, skin temperature, activity, posture
Data StorageOn-body storage and cloud storage
Intended UseRemote patient monitoring, clinical trials, and general health monitoring
FunctionsContinuous monitoring, data transmission