Olympus CelonLab ENT Instrucciones De Uso página 11

Instructions for Use
Audio-frequency if impedance too high
Rated supply voltage
Rated supply frequency
Power input at max. power
Power fuses (2 x)
Power connection line
Dimensions (W x H x D)
Weight
Protection class
Classification according to Medical Devices
Directive:
Foreign body/moisture protection
Transport conditions:
Storage conditions:
Operating conditions:
Standards and directives applied:
93/42/EEC MDD
EN ISO 13485
EN 60601-1
EN 60601-1-2
EN 60601-2-2
EN ISO 14971
W7098046
EN
≈ 2.5 kHz, pulsed with approx. 1 Hz
100 ... 120 V~
200 ... 240 V~
50 ... 60 Hz
95 VA
1.6 A T-lag, 250 V, 5x20 mm, UL/CSA
REF: WB991007 (100 ... 120 V~)
0.8 A T-lag, 250 V, 5x20 mm, UL/CSA
REF: WB991001 (200 ... 240 V~)
IEC 60320-1/C13
267 x 165 x 335 mm
Unit:
Footswitch:
I
IIb / II
Europe / US (FDA)
IP 21, footswitch IP 68
Temperature -34 ... +65 °C
Relative humidity 15 ... 80 %, non-condensing
Temperature -25 ... +60 °C
Relative humidity 15 ... 80 %, non-condensing
Temperature +10 ... +40 °C
Relative humidity 15 ... 80 %, non-condensing
Conformity assessment
Quality assurance systems – Medical Devices –
Specific requirements for application as per ISO 9001
Medical electrical devices
Medical electrical devices (EMC)
Medical electrical devices (electrosurgical devices)
Medical devices risk analysis
CelonLab
7.3 kg
1.0 kg
ENT
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