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ENGLISH
1. Indications for Use
Penguin RFA is indicated for measuring the stability of dental implants in the oral cavity or craniofacial region.
2. Figures and System components
Fig 1 Penguin
RFA
Instrument
Included in package
Fig 2 MulTipeg Driver
Included in package
Fig 3 Example MulTipeg
Not included, sold separately
Fig 4 Mains adapter
Included in package
Fig 5 Measurement position
Shows how the instrument tip is held towards the MulTipeg during a measurement
3. 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.
4. Operating environment
Ambient temperature: 16° to 40° C (60°-104° F)
Relative humidity: 10% to 80% Rh, non-condensing
5. Transport and storage
Ambient temperature: -20° to 40° C (60°-104° F). Relative humidity: 10%-85% Rh. Atmospheric pressure: 500 hPa- 1060 hPa (0.5-1.0
atm).
6. 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.
7. Characteristics
Penguin RFA 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, 1-100, 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.
8. 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.
No user modification of this equipment is allowed
Batteries should be collected separately
Autoclavable up to 134° C
Manufacturing year
Delivered Non-sterile
Warning
Measurements should only be performed using the correct MulTipegs. Using the wrong MulTipeg could cause
erroneous measurements or damages to the MulTipeg or implant.