NSK Osseo 100 Mode D'emploi page 3

1. Indications for Use
Osseo100 is indicated for measuring the stability of dental implants in the oral cavity or craniofacial region.
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 Osseo100 Instrument
Fig 2 MulTipeg Driver Included in package
Fig 3 Example MulTipeg
Fig 4 Mains adapter and plugs
Fig 5 Measurement position
4. Specifications
Power input: 5VDC, 1 VA
Charger input: 100-240 VAC, 5VA
Instrument weight: 100g
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.
5. Operating environment
Ambient temperature: 16° to 40° C (60°-104° F)
Relative humidity: 10% to 80% Rh, non-condensing
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).
7. Symbols
Consult Instructions for Use
Magnetic field warning
CE mark
Rx Only Caution: Federal law restricts this device to sale
by or on the order of a physician or dentist.
Type BF applied part
The instrument and MulTipeg
8. Characteristics
Osseo 100 is an instrument for measuring the stability (ISQ) of dental and craniofacial implants. The instrument measures the resonance frequency of a
measurement pin "MulTipeg" and presents it as an ISQ value. The ISQ value, 1-99, reflects the stability of the implant – the higher the value, the more stable the
implant.
The instrument measures the ISQ-value with a precision of +/- 1 ISQ unit. When mounted onto an implant, the MulTipeg resonance frequency can vary up to 2 ISQ
units depending on the tightening torque.
Warning: Use of this equipment adjacent to or stacked with other equipment should
be avoid because it could result in improper operation.
9. MulTipeg
The MulTipeg is made from titanium, and has an integrated grip for the driver on top. Inspect the MulTipeg for damage before use. Damaged MulTipegs should not
be used due to the risk of erroneous measurements.
There are different MulTipegs available made to fit different implant systems and types. Please refer to the updated list from the supplier.
Measurements should only be performed using the correct MulTipegs. Using the wrong MulTipeg could cause
erroneous measurements or damages to the MulTipeg or implant.
The instrument emits short magnetic pulses with pulse duration of 1 ms and strength of +/- 20 gauss, 10 mm
from the instrument tip. Precautions might be necessary when using the instrument close to cardiac
pacemakers or other equipment sensitive to magnetic fields.
ENGLISH
Included in package
Not included, sold separately
Included in package
Shows how the instrument tip is held towards the MulTipeg during a measurement
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
Autoclavable up to 134° C
Manufacturing year
Delivered Non-sterile
Warning