VitalConnect VitalPatch User Manual

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IFU-02 Rev. J Page ! of ! 1 17 DCO-M-1556 | Date: 06Mar2018
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The VitalPatch® device (VitalConnect Sensor) is a component of the VitalConnect Platform. The VitalPatch device is a wireless, battery-operated wearable biosensor, worn on the torso to record heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, fall detection, activity (including step count) and posture (body position relative to gravity including fall detection). The VitalPatch device continuously gathers physiological data from the person being monitored and then transmits encrypted data via bi-directional communication to the Relay device when in range of the Relay device. The encrypted wireless data provided by the VitalPatch device may be downloaded from the Relay device for storage, or integrated into a Third-Party Relay Application via the APIs of the Relay Software Library. Additionally, wireless data may be transferred to and stored on an optional Secure Server for future analysis if there is an active server connection. The data provided by the VitalPatch device is intended to aid caregivers in making diagnoses by providing additional information to standard of care patient monitors.
During normal operation, data is collected by the VitalPatch device and transmitted immediately to the Relay device. A continuous connection is needed between the VitalPatch device and the Relay device in order to facilitate continuous data transmission. The continuous wireless transmission of data occurs with a latency of seconds between data collection and transmission.
Indications for Use
The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Sensor for storage and analysis. The VitalConnect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.
The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.
Contraindications
The VitalPatch device is not intended for use on users who have implanted defibrillators or pacemakers.
The VitalPatch device is not intended as a stand-alone diagnostic monitor, but the data may be applicable for use in diagnosis.
Warnings
The VitalPatch device is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices.
Depending on wireless connectivity, a temporary interruption of data transmission is possible, which may impact continuous or real-time monitoring. Data will be stored on the device for transfer once connectivity is reestablished.
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The nature of hydrocolloid adhesives may cause adverse skin reactions. Healthcare providers should advise patients to seek medical attention if either of the following occurs:
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A severe adverse event
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An allergic reaction persisting beyond 2-3 days
Histories of skin irritations should be considered before placing the VitalPatch device on a patient.
Do not use the VitalPatch device during an MRI scan or in a location where it will be exposed to strong electromagnetic forces.
Only place the VitalPatch device on intact skin.
Clinical validation has not been performed on patients who are pregnant or breastfeeding.
Precautions
For data to be sent to a healthcare professional for review:
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The VitalPatch device must be properly adhered to the patient.
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The patient must remain in range of their Relay device.
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The VitalPatch device must have adequate power for data transmission. Notification of the VitalPatch device battery level will indicate when the battery power is low.
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The Relay device must remain charged and functional for data transmission. Wireless connectivity must be active for transmission of data from the Relay device to the server.
If uninterrupted continuous data monitoring is necessary for patient safety, remote monitoring in home settings using the VitalPatch device may not be appropriate.
Data collected by the VitalPatch device for patients experiencing cardiac arrhythmia may indicate slightly higher or lower respiratory rate values, compared to visual observation, for the duration of the active arrhythmic episode.
The VitalPatch device is Single Use Only. Do not reapply the device once it is removed.
Wireless electronic devices may cause signal interference during data transmission. Avoid close proximity with interfering devices.
Medical electrical equipment or electrical stimulators attached to the patient’s body may degrade VitalPatch signal quality or produce erroneous results from the biosensor. The potential interaction must be evaluated and authorized by the responsible organization.
Do not use the VitalPatch device if the package has been opened, or appears used, damaged, or expired.
The VitalPatch device may be used while showering. Minimize exposure directly under the shower head, excessive contact with soap, or scrubbing. Gently dry the device after showering. Do not submerge the device or use in a sauna.
Wear only one VitalPatch device at a time.
If discomfort or irritation occurs, the VitalPatch device should be removed. If mild soreness or redness is experienced after removing the device, do not apply a new device in the same location. Choose another recommended location.
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Incorrect handling, excessive force, or dropping the VitalPatch device may cause malfunction or permanent damage.
Keep the VitalPatch device away from children and pets. The device may be a choking hazard, and may be harmful if swallowed.
If VitalPatch fails to operate, contact your healthcare provider immediately.
Dispose of the VitalPatch device per local laws, care facility laws or hospital laws for routine/non­hazardous electronic waste.
Product Storage
Storage temperature range: 0 – 40o C
Storage relative humidity range: 10 – 95% RH
System Interoperability
The VitalPatch device is compatible with Relay devices and software developed with the VitalConnect Application Programming Interface (API). Please contact VitalConnect, Inc. to obtain implementation information, including the MAN-001, VitalConnect Platform Integration Manual – Developer Guide.
VitalPatch Operating Instructions
Note: It is recommended that healthcare providers advise users to replace the VitalPatch device after 120
hours (5 days) of use. To preserve data, the VitalPatch device must be connected to the Relay device prior to the end of battery life (120 hours). The device will no longer be usable after 120 hours.
VitalPatch Overview
Note: Orientation of the Logo Side and Battery Side are important when placing the device on the patient.
See image below for a view of the VitalPatch device, showing the logo side and battery side.
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Product Handling
Ensure hands are clean and dry before handling the VitalPatch device. Gloves are recommended when handling the device.
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When handling the VitalPatch device, do not touch the adhesive. The steps below should minimize the chance of touching the adhesive. If the liners have been removed it is best to hold the device in the center with your thumb and fingers. Contact with the adhesive prior to application to the patient will deteriorate the adhesive and compromise wear duration. See image to the right.
Skin Preparation and Application
Step 1: Prepare skin.
The primary application site is located on the upper left chest. If the device cannot be placed on the primary application site, use the secondary application site instead. The secondary application site is located just left of the centerline, below the chest on the rib cage. For a good connection and proper operation, the VitalPatch device should NOT be worn over areas with a high concentration of body hair. Remove body hair in the area of device placement before applying the device. See image to the right.
Step 2: Remove VitalPatch from pouch.
Tear open the pouch using the notch mark and remove the VitalPatch device carefully, to avoid pressing the Power Button.
Retain the pouch or the adhesive backing with the device Bluetooth ID number. You will need this information to connect to your software application after the VitalPatch device is applied to the patient. The Bluetooth ID number can be found on the pouch label or on the adhesive backing in both human readable and barcode formats. See image to the right.
Step 3: Power-on VitalPatch.
Locate and press the Power Button. Look for a green light illuminating temporarily to confirm the device is powered on. See image to the right.
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Note: For all patients, use an alcohol wipe to clean skin where the entire device will contact skin and allow site to dry. The application site should be free of oils and lotions to maximize adhesion.
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Step 4: Position VitalPatch on the body.
With the adhesive backings still adhered, place the VitalPatch device on a flat body surface on the left chest with one electrode two fingers below the suprasternal (jugular) notch, and angled diagonally toward the heart. The exact angle is not critical; it is more important to locate the flattest surface of the chest for the VitalPatch device placement in order to minimize movement during the monitoring session. The battery side of the VitalPatch device should be pointed to the left side of the patient's chest. See image to the right.
If the device cannot be placed in the Primary Location use
the Secondary Location instead. The Secondary Location is located just left of the centerline, below the chest on the rib cage, positioned horizontally in an area with minimal body curvature. This location is not recommended for obese persons.
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Note: The VitalConnect logo should be oriented such that it is readable by someone facing the patient when it is applied. The battery will be closest to the left side of the chest.
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