User's Manual Part 1

xvii
Precautions Prior to Using the Capsule Sensor
Read before administering capsule!
Limitations of Capsule Sensor
The VitalSense ingestible capsule thermometer is a Class II Medical
Device according to 21 CFR 882.1845 and is classified as a Surface
Contacting Device according to ISO 10993-1. The capsule is intended to
be used in contact with the mucosal membrane (alimentary tract) only.
The VitalSense ingestible capsule thermometer must not be used in any
situation where the mucosal membrane is already breached by surgery or
trauma. The VitalSense ingestible capsule thermometer is not intended to
be used as an implant. For additional information, contact Mini Mitter
Company, Inc. See “Contacting Mini Mitter Technical Support” on
page-v.
Description
• Supplied as one Capsule Sensor per package
• Sensor is colored biocompatible polycarbonate
• Temperature Sensing Range: 25 °C to 50 °C
• Reception Range: Maximum of 1 meter
• Battery life following activation: maximum of 240 hours (10 days)
Indications
An indication is a sign or circumstance that indicates proper treatment.
• The VitalSense Capsule Sensor is a wireless, miniaturized, externally
activated, ingestible, biocompatible thermometer.
• It is to be used for monitoring vital signs (core body temperature) as
part of a complete physiological sensor and monitoring system.
• Once ingested, the patient is not restricted to a medical environment.
• The Capsule Sensor may be taken without regard to dietary restrictions.
• It 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:
• Abnormalities in swallowing
• Esophageal or bowel strictures
• Fistulas
• Gastrointestinal obstructions