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8. Characteristics
Penguin RFA 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 dierent MulTipegs available made to fit dierent
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 dierent stabilities in dierent
directions. Make sure to measure from dierent 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 o automatically. When the
batteries are charging, the blue LED is lit. When the batteries
are fully charged the light goes o. 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/o
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 o, press and hold the operating key until the
instrument turns o. The instrument will power down
automatically after 30 seconds of inactivity.
14.2 Measurement Penguin RFA
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
Cleaning
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.
English US
Do not autoclave the instrument.
The instrument must be used with a cover in all
uses. (Only US).
The instrument must be cleaned with a
disinfectant between patients.
15.2 MulTipeg and MulTipeg Driver
Inspect the MulTipeg and MulTipeg Driver for damage
before use. Dispose of the MulTipeg if there are visible
damages such as severe miscoloring or damage. Dispose of
the Driver if the connection part (to the MulTipeg) is visibly
worn.
Cleaning
Immerse the device in 1% Alconox solution in tap water (20-
30°C) for 5 minutes. Brush the device with an interdental
brush for 1 minute, in the solution. Rinse in running tap water
(25–35°C) for 10 seconds. Dry with a lint-free towel.
Sterilization
Sterilization should be made in a pre-vacuum steam
sterilizer (autoclave) according to ISO 17665-1. Clean the
products and put them in an FDA-cleared (USA) autoclave
bag before sterilization. The following sterilization process
shall be used:
• At least 3 minutes at 134 (-1/+4)°C or 273 (-1.6/+7.4)°F
• 30 minutes of drying time
Follow the instruction for the autoclave that is used.
Do not clean the MulTipeg by ultrasound.
Thiscould cause damage to the MulTipeg.
16. Lifetime
The batteries are expected to last >500 charge cycles before
a noticeable change in capacity. This corresponds to a life-
time of 5 years. The internal batteries can be fully charged
more than 500 times. The instrument should not be left un-
charged for more than 1 year, to avoid change in capacity.
The MulTipeg Driver is guaranteed for at least 100 autoclave
cycles, and a MulTipeg is guaranteed for at least 20 auto-
clave cycles, before they are degraded in any way.
17. Troubleshooting & testing
The instrument can be tested by using the ISQ tester (fig. 6).
Turn on the instrument and hold the tip close to the top of
the pin. When a signal is received, a beep is heard and then
a set ISQ-value in the range shown on the label is shown of
the display.
17.1 Possible errors
• Dicult to achieve a measurement:
In some cases, it is more dicult for the instrument
to make the MulTipeg vibrate. If so, try to hold the
instrument tip closer to the top of the MulTipeg. Check
also that no soft-tissue is touching the peg which could
aect the vibration. When the device is measuring, the
measurement symbol is shown on the display.
• Noise warning (audible and visible on the display):
An electric device close to the instrument is causing the
warning symbol to appear. Try to remove the source.
• The instrument suddenly turns o:
The instrument turns o automatically after 30 seconds of
inactivity. It may also turn o if the battery level is too low
or due to any of the error codes described below.
• Not all segments are lit up when instrument is started:
The instrument is damaged and has to be sent for repair
or exchange.
17.2 Error codes
If malfunctioning, these error codes are shown on the display
before it turns o:
E1: Hardware error. Malfunctioning electronics
E2: Noise error. Shown if constant electromagnetic noise is
present
E3: Pulse power error. Malfunctioning magnetic pulse
generation
Use of accessories and spare parts other than
those specified or provided by the manufacturer of
this equipment could result in increased emissions
or decreased electromagnetic immunity of this
equipment and result in improper operation.
18. Accessories & Spare Parts
Model MulTipeg
Driver
Sterile
Cover
Mains adapter
Model No.
UE05WCP-052080SPC
Or
UES06WNCP-052080SPA
REF 55003 55105 55093
55263
Model EU plug UK plug AU plug US plug ISQ tester
REF 55094
55264
55095
55265
55096
55266
55097
55267
55217
MulTipeg: Please refer to the updated list from the supplier.
19. Service
Any serious incident that has occurred in relation to the device
should be reported to Integration Diagnostics Sweden AB,
and the competent authority of your state.
20. Serious incidents
Any serious incident that has occurred in relation to the device
should be reported to Integration Diagnostics Sweden AB,
and the competent authority of your state.
English US
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