Air Fx Irrigator Instructions for Use - US Page 23
5 General Technical Specifications
5.1 Device Specifications
Output Air Flow Rate: 8 to 12 liters/minute (fixed flow rate)
Output Air Temperature: Cool 20°C to 30°C (1°C increments)
Warm 40°C to 50°C (1°C ncrements)
Accuracy: +/- 0.5°C
Stability: +/- 0.5°C, +/- 0.5 liters/min
Time to temperature: < 3 minutes
Distilled water: 220cc (7.4 oz)
Otoscope speculums: 2.75 mm and 4.25mm (single use)
Computer connection: USB 1.1 or faster, 3 m (9.8 ft) cable
Case dimensions: 35W x 32D x 22H cm (13.8 x 12.6 x 8.7 in)
Air hose length: 3 m (9.8 ft)
Weight: 8 kg (18 lb)
Voltage: 110-130 VAC @ 50-60 Hz
220-240 VAC @ 50-60 Hz
Fuses: 1 x 2A (110VAC units)
2 x 1A (220VAC units)
Power consumed: 105VA
Chassis leakage current: < 300 µA (single fault condition)
CE Number: 500651
Product model: Air Fx
Classification: IIa according to MDD 93/42/EEC Annex IX, rule 10
Complies with: Annex V of the Medical Device Directive 93/42/EEC
as amended by Directive 2007/47/EC
Notified Body: BSI Management Systems CE 0086
Compliance
Standards: 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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