User's Manual Part 1

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Precautions Prior to Using the Dermal Patch Sensor
Read before administering Dermal Patch Sensor!
Description
• Supplied one Dermal Patch Sensor per package
• Patch is biocompatible, colored plastic
• Temperature Sensing Range: -20 °C to 60 °C
• Reception Range: maximum of 2 meters
• Battery life following activation: maximum of 240 hours (10 days)
Indications
An indication is a sign or circumstance that indicates proper treatment.
• The VitalSense Dermal Patch is a wireless, miniaturized, externally
activated, dermally affixed, biocompatible thermometer.
• The Dermal Patch Sensor is to be used for monitoring vital signs
(external skin temperature) as part of a complete physiological sensor
and monitoring system.
• The subject is not restricted to a medical environment. The subject may
shower and participate in normal activities while the Dermal Patch is in
place.
• The Dermal Patch is a single-use sensor.
Contraindications
A contraindication is any circumstance that indicates a form of treatment
may be inappropriate.
This device is contraindicated if the patient presents or has a history of any
of the following conditions:
• This product should not be used if the patient has known skin allergies,
a break in the skin at the application site, or other abnormal skin
conditions. If a skin rash occurs, notify the health care practitioner
immediately.
Warnings
A warning indicates a condition that may endanger the subject.
• DO NOT attempt an MRI (magnetic resonance imaging) if a Dermal
Patch has been affixed. Remove the device prior to MRI.
Affix an MRI Warning wrist band (supplied) to the subject with
instructions to wear it until the Dermal Patch has been removed.
• DO NOT affix Dermal Patch if any damage is visible to the packaging
or the device.
• Keep sensors away from small children. They can be a choking hazard.