Bausch OccluSense - DEVICE DESCRIPTION AND USE

3 Intended Use
Recording and presentation of the masticatory pressure distribution in order to localize
relevant pressure points of the patient's entire dental arch with full-grown dentures (for
temporary use only). The application is intended exclusively for dentists and
physicians/physiotherapists with specialized training (CMD, craniomandibular
dysfunction).
4 Device description (components, etc.)
The OccluSense
®
-System consists of the following components:
- Handheld BK 5001
- Charging station incl. Power supply BK 5002
- iPad App available in the Apple AppStore BK 5100
(requires an Apple iPad [no medical device], not included)
- 1 test sensor BK 5011
- 25 OccluSense
®
-Sensors BK 5025
- Manual BK 5051
- 3 NiMH rechargable batteries BK 5013
- 1 Screwdriver IP 6 BK 5012
The medical device components do not contain any of the following substances:
- Pharmaceuticals
- Tissues or cells of human origin or their derivatives
- Tissues or cells of animal origin or their derivatives within the meaning of
EU Regulation 722/2012
The touchable surfaces of medical device components consist of physiologically harmless
plastics and colorants.
Environmental conditions:
Temperature range 0° … +35°
Relative humidity 20% … 90%. noncondensing
Atmospheric pressure 650hPa … 1060hPa
max. height a.s.l. 3000m
International Protection Rating: IP 40
Class: Class II
12