Aqua Stim Water Irrigator Instructions for Use - EN Page 25
5 General Technical Specifications
5.1 Device Specifications
Water Flow Rate: 250ml / 30 seconds (fixed)
Flow accuracy: +/- 15ml / 30 seconds
Duration of irrigation: Adjustable from 15 to 40 seconds
Irrigation Temperature: 30
°
C Cool irrigation
44
°
C Warm irrigation
Accuracy at tip: +/- 1
°
C
Stability of temperature: +/- 1
°
C
Time to temperature: < 3 minutes
External water container: ~ 3.5 liters (approx. 14 irrigations)
VNG computer interface: USB 1,1 or faster
Dimensions w/ handle mounted: 35(w) x 30(d) x 21(h) cm / 13.8(w) x 12(d) x 8.3(h) in.
Water hose length (detachable): 3m (9.8ft) length with a rubber protective cover
Weight of hose and handle: 0,9 kg (2 lbs)
Weight of cabinet (drained): 5,4 kg (11.9 lbs)
Voltage: 110-130 VAC or 220-240 VAC
Power: 600 watts
Chassis leakage current: < 300 µA (single fault)
Fuse size: 110 -130VAC: 2x 8A SB Fuses
220 - 240VAC: 2x 4A AT Fuses
CE Number: 500651
Product model: Aqua Stim
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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