Technical Specifications - KULZER Translux Wave Gebrauchsanweisung

12

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:
- 24 -
Power supply for the hand piece:
Hand piece:
Light source:
Light guide:
Settable exposure cycles:
– Normal exposure
– "Soft-Start" exposure
Charging time of empty battery:
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 Wave)
Translux Wave 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 Wave.
Operation: Intermittent service: 120" ON – 40" OFF – max 2 times
running
High-luminosity LED.
LED Product Risk Group 2 (IEC 62471).
Wavelength range: 440 – 480 nm.
Dominant wavelength: Min. 440 nm – Max. 465 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
10 seconds of exposure time.
Acoustical signals:
1 beep at the start of exposure.
1 beep at the end of 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
Approx. 3 hours
– 300 mA – 50 / 60 Hz –.
.