Main
perfomance data of the DENAS device.
Power
supply:
|
|
- Battery
with diameter up to 16 mm, length up to 50 mm,
voltage, V
|
1.5±0.2
|
Pulse
series duration, sec
|
0.3
to 4.5
|
Duration
of pause between pulse series, sec
|
2±0.3
|
Pulses
frequency, Hz:
|
|
-
in dosed mode («Dosed»)
|
10±1
|
-
in constant mode («Co
nstant»)
|
77±3
|
Maximum
voltage from peak to peak is
|
420
V pp (open output)
416 V ss (R=1
MOhm)
130 V ss (R=10 kOhm)
|
Duration
pulse waveform at 50% from maximum amplitude
|
~
5.75 µs (R=1 MOhm)
~ 13 ms (R=10 kOhm)
|
Non-stop
operation time (with power supply accordi
ng to 2.1, without charging), hours, not less than
|
4
|
Unit
weight, kg, no more than
|
0.3
|
Dimensions
of the electric stimulator, mm, no more than
|
195x65x45
|
Dimension
of the built-in ectrodes, mm, no more than
|
7x50
|
The
form of impulses
|
|
The
unit will switch off automatically not later than
3 minutes after the last touch to any button (except «Off» button)
or after the last application of electrodes to the
patient's skin. Conditions
of exploitation: air temperature, °C 10-35,relative
air humidity at 25 °C, no more than 80.
After storage at air temperature below 10 °C
the unit should be kept under normal climate conditions
for not less than 2 hours before operation. The equipment
fulfil the Electromagnetic compatibility
(EMC) in accordance with the IEC-601-1-2 and the
additional
standard of the IEC-2-10. This medical product
bears the CE mark in
accordance with the Medical
Device Directive (MOD) 93/42/EEC. |
These
devices are allowed to be used in medical practice by
the order of Ministry of Health of the Russian Federation,
Registered Certificate 29, No. 199/40-5, August, 23,
1993. Safety of the device is guaranteed by the State
license of Ministry of Health and the Medical Industry
of the Russian Federation and certificates of conformity.
Russian
Federal Service of control the public health and social
development sphere has granted “DENAS MS” Corporation
with Registration certificate ¹ FS-2005/004 for “Dynamic
electric stimulation” method on the 4-th of March,
2005.
The
Scenar is regulated by the United States Food and Drug
Administration, under 21 CFR 882.5050. Generic name:
device, biofeedback, Product Code HCC, Class II exempt
from 510 (k) pre-market notification according to FDA
Notice FR21ja98-84 as a battery powered, professional
use device for relaxation training and muscle reeducation.
|
See
more about DENAS:
Main
resources of the DENAS
Main
perfomance data of the DENAS device
Our
devices for DENS-therapy:
DENAS
DiaDENS
|
