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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 (2 each):
Power consumed:
The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device
Directive 93/42/EEC.
Approval of the quality system is made by TÜV – identification no0123
The DEVICE is an active, diagnostic medical product according to the class IIa of the EU medical
directive 93/42/EEC.
Compliance
Standards:
D-0128226-A – 2020/12
Air Fx Caloric Irrigator – Instructions for Use - US
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
110VAC units: T2AL 250V
220VAC units: T1AL 250V
105VA
IEC 60601-1:2005 + AMD1:2012- Basic safety & Essential Performance
IEC 60601-1-2:2012 - EMC
Page 17
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