The DrugRelief® percutaneous electrical nerve field stimulator (PNFS) is designed to administer auricular neurostimulation treatment over 120 hours. Stimulation is performed by sending electrical pulses emitted through needles strategically positioned in the ear. The ear provides numerous points for stimulation within a small area.
DrugRelief® neurostimulation therapy is used mainly to reduce the symptoms of drug withdrawal during detoxification. Drug Relief® therapy allows continuous neurostimulation over a period of 5 days while offering the patient a high degree of comfort and mobility. Use of the Drug Relief® therapy allows for a minimized use of opioid agonist treatment and in some cases may eliminate it.
DrugRelief® devices come packaged 5 to a box.
Basic Unit Characteristics
Parameter |
Response |
|
Device Name or Model |
Drug Relief® |
|
Manufacturer |
DyAnsys® India Private Ltd |
|
Number, Size and type of batteries |
Three Zinc air Battery |
|
Average DC current through electrodes when device is on but no pulse are being applied |
<70 micro Amp |
|
Number of output modes |
One (Rectangular Wave) |
|
Number of Output Channels |
Synchronous or alternating? |
Alternating |
Method of channel isolation? |
RC filter Isolation |
|
Regulated Current or Regulated voltage? |
DC constant Volts |
|
Software/Firmware/ Microprocessor Control? |
Microcontroller flash with internal oscillator 0.5MHz |
|
Automatic Overload Trip? |
No |
|
Automatic No- Load Trip? |
No |
|
Automatic Shut off? |
Yes |
|
Used Override Control? |
No |
|
Indicator Display |
On/ off Status? |
No |
Low Battery? |
No |
|
Voltage/ Current Level? |
No |
|
Timer Range (minutes) |
180 minutes |
|
Compliance with Voluntary Standards? |
NA |
|
Compliance with 21 CFR 898 |
Yes |
|
Weight (lb., oz) |
1.1 lbs |
|
Dimensions (in.) [H x W x D] |
50x27x7mm |
|
Housing Materials and Construction |
ABS plastic Enclosure with medical grade |
Output Specification
Parameter |
Response |
|
Mode or Program Name |
Opiate withdrawal |
|
Waveform (e.g., Pulsed monophasic, biphasic) |
Biphasic (Alternative pulse) |
|
Shape (e.g., rectangular wave) |
2.02 V Amplitude @ 500Ω |
|
2.64 V Amplitude @ 1 KΩ |
||
3.2 V Amplitude |
||
Maximum Output Voltage (volts) (+/- _20___%) |
20mV @ 500Ω |
|
18mV @ 2 KΩ |
||
13mV @ 10 KΩ |
||
Duration of primary (depolarizing) Phase (msec) |
980µsec/phase |
|
Pulse Duration (sec) |
980µSec |
|
Frequency (Hz) or Rate (pps) |
1 -10Hz |
|
For multiphasic waveforms only: |
symmetrical phases? |
NA |
|
Phase Duration (include units) (states range, if applicable) (both phases, if asymmetrical) |
No |
Net Charge (microcoulombs (mc) per pulse) (if zero, state method of achieving zero net charge |
|
|
Maximum Phase Charge, (mc) |
|
|
Maximum Current Density, (mA/cm², r.m.s.) |
100mA |
|
Maximum Average Power Density, (W/cm²), (using smallest electrode conductive surface area) |
|
|
Burst Mode (i.e., pulse trains): |
(a) Pulses per burst |
10800 pulse @ 500Ω |
|
(b) Bursts per second |
0.000093 @ 500Ω |
|
(c) Burst duration (seconds) |
10800 @ 500Ω |
|
(d) Duty Cycle [Line (b) X Line (c)] |
1000 Pulses @ 500Ω |
ON Time (Seconds) |
7200 |
|
OFF Time (Seconds) |
60 |
|
|
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