Olympus CelonLab ENT - Page 11

Instructions for Use EN CelonLab ENT
W7098046 11
Audio-frequency if impedance too high ≈ 2.5 kHz, pulsed with approx. 1 Hz
Rated supply voltage 100 … 120 V~
200 ... 240 V~
Rated supply frequency 50 … 60 Hz
Power input at max. power 95 VA
Power fuses (2 x) 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~)
Power connection line IEC 60320-1/C13
Dimensions (W x H x D)
267 x 165 x 335 mm
Weight
Unit: 7.3 kg
Footswitch: 1.0 kg
Protection class I
Classification according to Medical Devices
Directive: Europe / US (FDA)
IIb / II
Foreign body/moisture protection IP 21, footswitch IP 68
Transport conditions: Temperature
Relative humidity
-34 ... +65 °C
15 ... 80 %, non-condensing
Storage conditions: Temperature
Relative humidity
-25 ... +60 °C
15 ... 80 %, non-condensing
Operating conditions: Temperature
Relative humidity
+10 ... +40 °C
15 ... 80 %, non-condensing
Standards and directives applied:
93/42/EEC MDD Conformity assessment
EN ISO 13485
Quality assurance systems – Medical Devices –
Specific requirements for application as per ISO 9001
EN 60601-1 Medical electrical devices
EN 60601-1-2 Medical electrical devices (EMC)
EN 60601-2-2 Medical electrical devices (electrosurgical devices)
EN ISO 14971 Medical devices risk analysis