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Air Fx Irrigator Instructions for Use - US
5 General Technical Specifications
5.1 Device Specifications
Output Air Flow Rate:
Output Air Temperature:
Accuracy:
Stability:
Time to temperature:
Distilled water:
Otoscope speculums:
Computer connection:
Case dimensions:
Air hose length:
Weight:
Voltage:
Fuses:
Power consumed:
Chassis leakage current:
CE Number:
Product model:
Classification:
Complies with:
Notified Body:
Compliance
Standards:
8 to 12 liters/minute (fixed flow rate)
Cool 20°C to 30°C (1°C increments)
Warm 40°C to 50°C (1°C ncrements)
+/- 0.5°C
+/- 0.5°C, +/- 0.5 liters/min
< 3 minutes
220cc (7.4 oz)
2.75 mm and 4.25mm (single use)
USB 1.1 or faster, 3 m (9.8 ft) cable
35W x 32D x 22H cm (13.8 x 12.6 x 8.7 in)
3 m (9.8 ft)
8 kg (18 lb)
110-130 VAC @ 50-60 Hz
220-240 VAC @ 50-60 Hz
1 x 2A (110VAC units)
2 x 1A (220VAC units)
105VA
< 300 µA (single fault condition)
500651
Air Fx
IIa according to MDD 93/42/EEC Annex IX, rule 10
Annex V of the Medical Device Directive 93/42/EEC
as amended by Directive 2007/47/EC
BSI Management Systems CE 0086
EN 60601-1:2006
Basic safety and Essential Performance
EN 60601-1-1:2001 Safety of Medical Electrical Systems
EN 60601-1-2:2007 EMC Directive
EN 62304:2006
Medical Device Software
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