Specifications; Safety And Performance Standards - Enraf Nonius Endopuls 811 Manual Del Usuario

15 Specifications

Endopuls 811
Dimensions
Weight
Power supply
Fuse
Conformity
Frequency range
3 burst modes
Shock energy levels
4 selectable fixed settings
Mode of operation
Accuracy
Shockwave hand-piece:
Dimensions
Weight
Service life
Dimensions
(complete with case)
Total weight
Environmental conditions
Operational environment
Storage / Transport
Short-term
Long-term

16 Safety and Performance standards

IEC 60601-1
Safety class according to IEC 60601-1
Medical device classification
60
Treatment system for electromagnetic generation / application of of
radial shockwaves in orthopaedics and physiotherapy.
L 350 mm / W 250 mm / H 140 mm
2.7 kg
100–240 VAC / 50/60 Hz, 220 VAC / 60 Hz
3,15 AT
Protection class I / Application class BF
1 Hz – 22 Hz, can be adjusted in 1 Hz steps
4, 8, 12 shots
60 – 180 in steps of 10 mJ and 185 mJ (at the applicator)
at 16 Hz max. 120 mJ
Intermittent use max. 6000shocks / 15min. break
± 20%
Ergonomic model with anodized aluminium case and fan cooling
230 mm in length, 50 mm diameter
850 g (with cable)
2,000,000 shocks (minimum)
Applicators exchangeable without any tools (6 / 15 / 25 mm diameter)
L 580 mm / W 470 mm / H 250 mm
12 kg (total with case)
10 to 25 °C (50 to 77 °F); 700 hPa – 1060 hPa, 20% to 80% rel. humidity,
not condensed
-10 to 55 °C (14 to 131 °F); 700 hPa – 1060 hPa, 20% to 80% rel. humidity,
not condensed
0 to 40 °C (32 to 104 °F); 700 hPa – 1060 hPa, 20% to 80% rel. humidity,
not condensed
: General requirements for the safety of electrical medical
systems, including Annex 1, national differences for Australia,
Canada and the United States.
: class I type BF
: This equipment complies with all requirements of the Medical
Device Directive (93/42/EEC).
: IIa