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

Aqua Stim Water Irrigator Instructions for Use - EN

5 General Technical Specifications

5.1 Device Specifications

Water Flow Rate:
Flow accuracy:
Duration of irrigation:
Irrigation Temperature:
Accuracy at tip:
Stability of temperature:
Time to temperature:
External water container:
VNG computer interface:
Dimensions w/ handle mounted:
Water hose length (detachable):
Weight of hose and handle:
Weight of cabinet (drained):
Voltage:
Power:
Chassis leakage current:
Fuse size:
CE Number:
Product model:
Classification:
Complies with:
Notified Body:
Compliance
Standards:
Performance
Systems
250ml / 30 seconds (fixed)
+/- 15ml / 30 seconds
Adjustable from 15 to 40 seconds
30 ° C Cool irrigation
44 ° C Warm irrigation
+/- 1 ° C
+/- 1 ° C
< 3 minutes
~ 3.5 liters (approx. 14 irrigations)
USB 1,1 or faster
35(w) x 30(d) x 21(h) cm / 13.8(w) x 12(d) x 8.3(h) in.
3m (9.8ft) length with a rubber protective cover
0,9 kg (2 lbs)
5,4 kg (11.9 lbs)
110-130 VAC or 220-240 VAC
600 watts
< 300 µA (single fault)
110 -130VAC: 2x 8A SB Fuses
220 - 240VAC: 2x 4A AT Fuses
500651
Aqua Stim
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
EN 60601-1-1:2001
EN 60601-1-2:2007 EMC Directive
EN 62304:2006 Medical Device Software
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Safety of Medical Electrical
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