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Idiomas disponibles
Idiomas disponibles
1. Indications for Use
Osseo 100+ is indicated for use in measuring the stability of implants in the oral cavity and 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 Systemcomponents
Fig 1 Osseo 100+ Instrument
Fig 2MulTipeg Driver
Fig 3 Example MulTipeg
Fig 4 Mains adapter and plugs
Fig 5 Measurement position
4. Specifications
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Power input: 5VDC, 1 VA
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Charger input: 100-240 VAC,5VA
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Instrument weight: 78g
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Charger safety class: EN 60601-1 Class II
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Instrument safety class: EN 60601-1 ME ClassII
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EMC: EN 60601-1-2, class B
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The instrument is intended for continuous use
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The instrument contains NiMHbatteries.
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Bluetooth specification:
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Frequency band: 2.4GHz ISM band(2.402-2.480GHz)
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Transmitting power: Class2 2.5mW[dBm]
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Modulation: GFSK
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Channnels: 40 channels with 2 MHz spacing
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Compatibility: EN 300 328, EN 300 489-1, EN301 489-17, EN 62479:2010
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Connection only possible to pairable instruments listed in chapter 19.
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No specific security aspects (other than those listed in 14.3) applies to the Bluetooth connection.
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. Atmospheric pressure: 500 hPa- 1060 hPa (0.5-1.0 atm).
7. Symbols
Warning
Follow instructions for use
Magnetic field warning
Autoclavable up to 134° C
Delivered Non-sterile
Catalog number
Lot/Batch code
Serial number
Bluetooth technology
Atmospheric pressure limit
8. Characteristics
Osseo 100+ is an instrument for measuring the stability (ISQ, Implant Stability Quotient) of dental and craniofacial implants. The instrument measures the
resonancefrequency of a MulTipeg and presents it as an ISQvalue. The ISQ value, 1-99, reflects the stability of the implant – the higher the value, the morestable
the implant.
Theinstrument measures the ISQ-value with a precision of +/- 1 ISQunit. When mounted onto an implant, the MulTipeg resonancefrequency can vary up to 2 ISQ
units depending on the tighteningtorque.
By connecting Osseo 100+ to a pairable instrument (defined in section 19), the ISQ value and battery status is transferred. For more information, see the pairable
instrument manual and "14. Usage" below.
Warning: Useofthis equipmentadjacent to orstacked with other equipment should
be avoid because it could result in improper operation.
ENGLISH
Included inpackage
Included inpackage
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
Keep dry
Temperature limit
Manufacturer
Manufacturing year
CE mark
Caution: Federal law restricts this device to sale
by or on the order of a physician or dentist.
Wastefromelectronic equipmentmust be handled
according to local regulations
Type BF Applied part
The instrument and MulTipeg
Federal Communications Commission (FCC) approved
equipment. FCC ID: 2AEMXY7011A00000, IC 20194-
Y7011A00000
Humidity limit
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