General Technical Specifications; Device Specifications - Interacoustics Aqua Stim Instructions For Use Manual

5 General technical specifications

5.1 Device specifications

Water Flow Rate:
Flow accuracy:
Duration of irrigation:
Irrigation Temperature:
Accuracy at tip:
Stability of temperature:
External water container:
VNG computer interface:
Dimensions w/ handle:
Water hose (detachable):
Weight of hose and handle: 0. 9 kg (2 lbs)
Weight of cabinet (drained): 5. 4 kg (11. 9 lbs)
Voltage:
Power:
External Fuse size:
Internal Fuse:
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-0128227-A – 2020/12
Aqua Stim Water Irrigator – Instructions for Use - US
250ml / 30 seconds (fixed)
+/- 15ml / 30 seconds
30 seconds (Adjustable from 30 to 15 seconds)
30 ° C Cool irrigation
44 ° C Warm irrigation
+/- 1 ° C
+/- 1 ° C
~ 3. 5 liters (approx. 14 irrigations)
USB 1,1 or faster
35(w) x 32(d) x 22(h) cm / 13. 8(w) x 12. 6(d) x 8. 7(h) in.
3m (9. 8ft) length with a rubber protective cover
110-130 VAC or 220-240 VAC
600 watts
110 -130VAC: 2x T8AH 250V Fuses
220 - 240VAC: 2x T4AH 250V Fuses
220 – 240VAC: T2. 5AL 250V
IEC 60601-1:2005 + AMD1:2012- Basic safety & Essential Performance
IEC 60601-1-2:2012 - EMC
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