User's Manual Part 2
D-4 Specification
Agency Standards Met
Limitations
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.
Medical Device
VitalSense system is cleared by the United States Food and Drug
Administration for marketing as a Class II medical device.
Clinical Thermometer
VitalSenses meets ASTM-E1112-00, Standard Specification for
Electronic Thermometer for Intermittent Determination of Patient
Temperature.
(For those VitalSense System owners needing “Determination of Accuracy” documentation related to
this specification, please contact Mini Mitter.)
Radio Emissions
VitalSense meets CFR Title 47, Part 15, Subpart C. FCC listing code is
JIAXTP1.
Human Safety
This device is classified as Type CF protection against electrical shock.
The VitalSense Monitor conforms to IEC 60601-1 (UL 2601-1).
Water Resistance
VitalSense monitor meets IEC 529-IP52, and NEMA 250-5.
Safety Labeling and Terminology
Instruction manual conforms to ANSI Z535.4-2002
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