9 Technical specifications of the medical device
9.1 Identification
Manufacturer SATELEC, a company of Acteon group
Name of the medical device Newtron LED handpiece
9.2 Handpiece
Length 112 mm
Diameter maximum 21 mm
Weight 73 g
9.3 Light
Light source LED
Light colour White
9.4 Length of cords
Handpiece cord 2 500 mm +/- 50 mm
9.5 Irrigation
Water pressure at inlet from 1 to 5 bars (15 to 73 p.s.i.)
Water output at the end of the handpiece 0 ml/min to 80 ml/min at 5 input bar
9.6 Environmental characteristics
Ambient operating temperature +10°C to +30°C
Operating RH 30% to 75%
Atmospheric operating pressure Between 800 hPa and 1060 hPa
Maximum operating altitude Equal to or less than 2000 metres
Storage temperature -20°C to +70°C
Storage RH 10% to 100 %, including condensation
Atmospheric storage pressure Between 500 hPa and 1060 hPa
Transportation temperature -20°C to +70°C
Transportation RH 10% to 100 %, including condensation
Atmospheric transportation pressure Between 500 hPa and 1060 hPa
9.7 Environmental restrictions
Usage premises
Usable in all medical premises. The medical device must not be used in
an operating theatre or outdoors.
Use in gas-filled atmosphere
The medical device is not designed for use in a type AP or APG gas-
filled atmosphere or in the presence of anaesthetic gases.
Immersion The handpiece must not be immersed.
9.8 Main performance characteristics
Ultrasonic vibrations of the tip or file fitted to the end of the conventional dental ultrasonic handpiece.
l Vibration frequency ≥ 28 kHz.
l Tip amplitude ≤ 200 µm.
User Manual | handpiece Newtron LED | J12611 | V4 | (07) | 01/2021 | NB62EN020D - Page 19/28
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