54
English
8. Characteristics
Osseo 100 is an instrument for measuring the stability
(ISQ) of dental implants. The instrument measures the
resonance frequency of a 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 avoided
because it could result in improper operation.
9. MulTipeg
The MulTipeg is made from titanium and has an integrated
grip for the MulTipeg 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.
10. Technical function
For bringing the MulTipeg into vibration, short magnetic
pulses are sent from the instrument tip. The magnetic
pulses interact with the magnet inside the MulTipeg and
cause the MulTipeg to vibrate. A pickup in the instrument
picks up the alternating magnetic field from the vibrating
magnet, calculates the frequency and from that, the ISQ
value.
11. ISQ-value
The stability of the implant is presented as an “ISQ value”.
The higher the value, the more stable the implant. The ISQ
is described in numerous clinical studies. A list of studies
can be ordered from the supplier.
12. Implant stability
An implant can have different stabilities in different
directions. Make sure to measure from different directions
around the top of the MulTipeg.
It is highly recommended to measure the ISQ value
at implant placement to have a baseline for future
measurements. When the ISQ is measured at a later stage,
a change in the ISQ value will reflect a change in the
implant stability. This way, the ISQ progression will support
the decision on when to load the implant.
Note: The stability value is an additional parameter for
deciding when to load the implant. The final treatment
decision is the responsibility of the clinician.
13. Batteries & charging
The instrument contains 2 NiMH battery cells that must
be charged before use. A full charge takes approximately
3 hours at 20°C or 68°F. Warmer room temperature will
increase the charging time. From fully charged, the
instrument can measure continuously for 60 minutes
before it needs to be recharged. The yellow LED is lit
when the battery needs recharging. The yellow LED
flashes when the battery reaches a critical level. When the
battery reaches a critical level, the instrument shuts off
automatically. When the batteries are charging, the blue
LED is lit. When the charging is ready, the light goes off.
The charger should not be plugged in while measuring due
to the risk of power line interference making it dicult to
measure.
14. Usage
14.1 Instrument on/off
To turn the instrument on, press the operating key. A short
beep should be heard and then all display segments are lit
up for a short while. Check that all display segments are lit.
The software version is then shown briefly before the
instrument starts to measure. If any error code (EX, where
“X” is the error number) is shown during start up, please
refer to the section “Troubleshooting”.
To turn off, press and hold the operating key until the
instrument turns off. The instrument will power down
automatically after 30 seconds of inactivity.
14.2 Measurement Osseo 100
A MulTipeg (fig 3) is mounted onto the implant by using the
MulTipeg driver (fig 2). Use hand-tightening with 6-8 Ncm
of tightening torque. Turn on the instrument and hold the
tip close to the top of the MulTipeg (fig 5). When a signal is
received, a beep is heard and then the ISQ-value is shown
on the display for a short while before the instrument
starts to measure again.
If electromagnetic noise is present, the instrument cannot
measure. The electromagnetic noise warning is audible
as well as visible on the display. Try to remove the source
of the noise. The source could be any electric equipment
close to the instrument.
Always use a thread, such as dental floss, to secure
the MulTipeg driver when working intra-orally.
15. Cleaning and maintenance
Before use, the parts should be cleaned and
disinfected.
15.1 Instrument
The instrument can be cleaned with wipes soaked with
detergent solution for one minute and then wiped for one
minute with water-soaked lint free wipes.
Specified detergent: Neodisher Mediclean forte.
For use in environments requiring sterility, the instrument
should be covered with a sterile cover.
Disinfection
Use a cloth soaked with 70 % isopropyl alcohol to wipe the
instrument for one minute, and then let the instrument dry
for two minutes before use.
54
English
7. Symbols
Warning
Catalogue
number
Keep dry
Caution: Federal law
restricts this device to
sale by or on the order of
a physician or dentist.
Follow
instructions
for use
Lot/Batch
code
Temperature
limits
Waste from electronic
equipment must be
handled according to
local regulations
Magnetic field
warning
Serial number Manufacturer Type BF Applied part
Autoclavable
up to 134° C
Atmospheric
pressure limit
Manufacturing
date
Humidity limit
Delivered
Non-sterile
Unique device
identifier
CE mark
Certification marks –
demonstrate compliance
to the requirements of
widely accepted product
safety standards.
Medical device
To Next Page
Loading...
