NSK Osseo 100+ Manual De Operación página 3

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.
No user
modification of
this equipment is
allowed.
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
• Bluetooth specification:
5. Operating environment
Ambient temperature: 16° to 40°C (60°–104°F)
Relative humidity: 10%–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.
Power supply:
Atmospheric pressure: 500 hPa–1060 hPa (0.5–1.0 atm).
Use only the
supplied mains
adapter and plugs.
Batteries should
be collected
separately.
3 3
• Battery type: AAA, rechargeable
• Voltage: 1.2 V
• Current: 900 mAh
• Frequency band: 2.4GHz ISM band (2.402–2.480GHz)
• Transmitting power: Class2 2.5mW[dBm]
• Modulation: GFSK
• Channnels: 40 channels with 2 MHz spacing
• Compatibility: EN 300 328, EN 300 489-1, EN301
489-17, EN 62479:2010Connection only possible to
pairable instruments listed in chapter 19.
• No specific security aspects (other than those listed
in 14.3) applies to the Bluetooth connection.
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