Penguin RFA - Page 9

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1. Indications for Use
Penguin RFA is indicated for measuring the stability of dental
implants in the oral cavity and the maxillofacial region.
Indication for use is patients undergoing dental implant
procedures and the intended patient population is patients
having dental implants.
Contraindication for use of Penguin RFA is implant systems
to which the MulTipeg could not be attached for mechanical
incompatibility reasons.
The direct clinical benefit of using Penguin RFA is measuring
and obtaining an objective value (ISQ-value) indicating the
implant stability.
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 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 and plugs
Included in package
Fig 5 Measurement position
Shows how the instrument tip is held towards
theMulTipeg during ameasurement
Fig 6 ISQ Tester
Not included, sold separately
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.
4. Specifications
• Power input: 5VDC, 1 VA
• Charger input: 100-240 VAC, 5VA
• Instrument weight: 82g
• Dimensions instrument: 201mm x 26mm x 31mm
• 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
• Contains NiMH batteries:
• Battery type: AAA, rechargeable
• Voltage: 1.2 V
• Current: 900 mA
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 atm – 1 atm).
6. Transport & 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).
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7. Symbols
Warning
Catalog
number
Unique device
identifier
CE mark
Follow
instructions
foruse
Lot/
Batchcode
Keep dry
Caution: Federal law
restricts this device to sale
by or on the order of a
physician or dentist.
Magnetic field
warning
Serial number
Temperature
limit
Waste from electronic
equipment must be
handled according to
local regulations
Autoclavable
up to134°C
Atmospheric
pressurelimit
Manufacturer Type BF Applied part
Delivered
Non-sterile
Electronic
instructions
for use
20XX-YY
Manufacturing
date
Humidity limit
Medical device
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English US