1. Indications for Use
Osseo 100 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
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
Only original parts
should be used.
No user
modification of
this equipment is
allowed.
7. Symbols
Warning
Follow
instructions
for use
Magnetic field
warning
Autoclavable up
to 134° C
Delivered
Non-sterile
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).
Power supply:
Use only the
supplied mains
adapter and plugs.
Batteries should
be collected
separately.
Catalogue
number
Lot/Batch
code
Serial number
Atmospheric
pressure limit
Electronic
instructions
for use
3
Keep dry
Temperature
limits
Manufacturer
Manufacturing
year
CE mark
5022524
English
Caution: Federal law
restricts this device to
sale by or on the order of
a physician or dentist.
Waste from electronic
equipment must be
handled according to
local regulations
Type BF Applied part
Humidity limit
Certification marks –
demonstrate compliance
to the requirements of
widely accepted product
safety standards.