Olympus CelonLab ENT Instrucciones De Uso página 11

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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
11

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