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NSK Osseo 100 - Indications for Use; Intended Users; Figures and System Components; Specifications

NSK Osseo 100
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32
English
32
English
1. Indications for Use
Osseo 100 is indicated for measuring the stability of
dental implant.
The intended patient population is patients having dental
implants.
The indication is patients undergoing dental implant
procedures.
Osseo 100 is contraindicated for implant systems to
which the MulTipeg could not be attached for mechanical
incompatibility reasons.
The direct clinical benefit is that the clinician can get an
objective value (an ISQ-value) of the implant stability.
2. Intended users
Professional health care users and professional health care
facility environments only.
Please read the instruction for use before the first usage.
3. Figures and System components
Fig 1 Osseo 100 Instrument
Included in package
Fig 2 MulTipeg Driver
Included in package
Fig 3 Example MulTipeg
Not included, sold separately
Fig 4 Mains adapter and plugs
Included in package
Fig 5 Measurement position
Shows how the instrument tip is held towards the
MulTipeg during a measurement
Fig 6 ISQ Tester
Not included, sold separately
Only original parts
should be used.
Power supply:
Use only the
supplied mains
adapter and plugs.
No user
modification of
this equipment is
allowed.
Batteries should
be collected
separately.
4. Specifications
Power input: 5VDC, 1 VA
Charger input: 100-240 VAC, 5VA
Instrument weight: 78g
Dimensions instrument: 202mm x 29mm x 25mm
Charger safety class: EN 60601-1 Class II
Instrument safety class: EN 60601-1 ME Class II
EMC: EN 60601-1-2, class B
The instrument is intended for continuous use
The instrument contains NiMH batteries
Battery type: AAA, rechargeable
Voltage: 1.2 V
Current: 900 mAh
5. Operating environment
Ambient temperature: 16° to 40° C (60°–104° F).
Relative humidity: 10% to 80% Rh.
Atmospheric pressure: 500 hPa – 1060 hPa (0.5–1.0 atm).
6. Transport and storage
Ambient temperature: -20° to 40° C (-4°–104° F).
Relative humidity: 10%–85% Rh.
Atmospheric pressure: 500 hPa–1060 hPa (0.5–1.0 atm).

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