•
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:
o
A severe adverse event
o
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:
o
The VitalPatch device must be properly adhered to the patient.
o
The patient must remain in range of their Relay device.
o
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.
o
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.