Heraeus Kulzer Translux Wave - 12 Technical specifications; Classification according to Directive 93;42;EEC; Classification according to IEC 60601-1; Charging unit specifications

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12 Technical specifications
Classification according to Directive 93/42/EEC: Class I (one)
Safety Standards: 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) and to IEC 60601-1-2 (third 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 and IEC 60601-1-1).
Classification according to IEC 60601-1: Class II, Type B, Applied Part: Light guide with protective cone.
IP 20 (Charging unit).
IP 20 (Translux Wave)
Charging unit: Translux Wave Charging unit
Power supply for the charging unit: Switching Power Supply (Direct Plug-In) manufactured by:
Phihong Technology CO LTD –
Model: PSACO5R-050.
Input: 100 – 240 V – 300 mA – 50 / 60 Hz –.
Output: 5 V – 1 A Max – .
Class II equipment
Power supply for the hand piece: Rechargeable Lithium-ion battery.
Manufacturer: Panasonic.
Model: NCR-18500.
Nominal Voltage: 3.6 V.
Nominal capacity (Typical): 2000 mAh
Hand piece: Model: Translux Wave.
Operation: Intermittent service: 120“ ON – 40“ OFF – max 2 times
running
Light source: High-luminosity LED.
Class 2M LED Product (IEC 60825-1).
Wavelength range: 440 – 480 nm.
Dominant wavelength: Min. 440 nm – Max. 465 nm
Light guide: 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
Settable exposure cycles:
– Normal exposure
10 seconds of exposure time.
Acoustical signals:
1 beep at the start of exposure.
1 beep at the end of exposure
– “Soft-Start” exposure 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 1 second for indication of “Soft-Start”-mode activation.
1 beep after 10 seconds of exposure.
1 beep at the end of exposure
Charging time of empty battery: Approx. 3 hours
Environmental conditions of unit:
Operation Transportation and
storage
Temperature 10°C – 35°C
(50°F – 95°F)
–20°C – 40°C
(–4°F – 104°F)
Relative humidity 45% – 85% 45% – 85%
Atmospheric pressure 800 – 1060 hPa 500 – 1060 hPa