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Technical specifications
Classification according to
Regulation EU MDR 2017/745:
Safety Standards:
Classification according to IEC 60601-1:
GB
Charging unit:
Power supply for the charging unit:
- 26 -
Power supply for the hand piece:
Hand piece:
Light source:
Light guide:
Settable exposure cycles:
– "Soft-Start" exposure
– Normal exposure
Charging time of empty battery:
Environmental conditions of unit:
Class I (one)
The product has been tested and found to comply to IEC 60601-1
(second edition) and to IEC 60601-1-1.
The product has been tested and found to comply to IEC 60601-1
(third edition) +AMD1:2012 and to IEC 60601-1-2:2014 (fourth
edition – for electro-magnetic compatibility – EMC).
The hand piece is intended for use within the patient environment
whereas the charger unit and the power supply adapter are not
intended for use within the patient environment.
Note: The patient environment is defined as an area 1.5 m from the
patient as per IEC 60601-1 (third edition) +AMD1:2012.
Class II, Type B, Applied Part: Light guide with protective cone.
IP 20 (Charging unit).
IP 20 (Translux 2Wave)
Translux 2Wave Charging unit
Switching Power Supply (Direct Plug-In) manufactured by:
Phihong Technology CO LTD – Model: PSACO5R-050L6.
Input: 100 – 240 V
Output: 5 V
– 1 A Max –
Class II equipment
Rechargeable Lithium-ion battery.
Manufacturer: Panasonic. Model: NCR-18500.
Nominal Voltage: 3.6 V.
Nominal capacity (Typical): 2000 mAh
Model: Translux 2Wave.
Operation: Intermittent service: 120" ON – 40" OFF –
max 2 times running
High-luminosity LED.
LED Product Risk Group 2 (IEC 62471).
Wavelength range: 385 – 510 nm.
Dominant wavelength: Min. 385 nm – Max. 470 nm
Lead-free multi core rod, 8 mm diameter.
Sterilisable in pre-vacuum steam autoclave:
4 minutes (minimum) at minimum temperature of 132°C + 3°C
(270°F + 5°F). Max. 500 cycles
20 seconds of exposure time. (The " Soft-Start " means increase of
light intensity from 50% up to 100% within 2 seconds.)
Acoustical signals:
1 beep at the start of exposure.
1 beep after 10 seconds of exposure.
1 beep at the end of exposure
20, 10 or 5 seconds of exposure time.
Acoustical signals:
1 beep at the start of exposure.
1 beep after 10 seconds of exposure (only 20 s Mode).
1 beep at the end of exposure
Approx. 3 hours
Temperature
Relative humidity
Atmospheric pressure
– 300 mA – 50 / 60 Hz –.
.
Operation
Transportation and
10°C – 35°C
–20°C – 40°C
(50°F – 95°F)
(–4°F – 104°F)
45% – 85%
45% – 85%
800 – 1060 hPa
500 – 1060 hPa
storage
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