ANSiStim®

ANSiStim®

The ANSiStim® Percutaneous electrical nerve stimulator (PENS) is designed to administer auricular neurostimulation treatment over several days. The ear provides numerous points for stimulation within a small area. Stimulation is performed by electrical pulses emitted through strategically positioned needles. The ANSiscope device monitors the pain condition of the patient before, during and after the treatment.

The ANSiStim® neurostimulation therapy is mainly used to treat pain. Use of the device is recommended for pre-operative, intra-operative and post-operative pain therapy as well as for the treatment of chronic pain.

ANSiStim® therapy allows continuous neurostimulation over a period of several days while offering the patient a high degree of comfort and mobility. Use of the ANSiStim® therapy provides advantages over drug therapy by minimizing possible side-effects caused by pain medications (i.e. opioid). In most cases, the patient continues to lead a normal life without side effects or any loss of quality of life.

ANSiStim devices come packaged 10 to a box.

Basic Unit Characteristics

Parameter

Response

Device Name or Model

ANSiStim®

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  (Square 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]

63x28x8 mm

Housing Materials and Construction

ABS plastic Enclosure with medical grade

Output Specification

Parameter

Response

Mode or Program Name

 

Waveform (e.g., Pulsed monophasic, biphasic)

Biphasic (Alternative pulse)

Shape (e.g., rectangular wave

3.9 V Amplitude @ 500Ω

4.32 V Amplitude @ 2 KΩ

4.2 V Amplitude

@ 10 KΩ

Maximum Output Voltage (volts) (+/- _20___%)

22mV @ 500Ω

18mV @ 2 KΩ

13mV @ 10 KΩ

Duration of primary (depolarizing) Phase (msec)

100 msec/phase

Pulse Duration (sec)

1 msec

Frequency (Hz) or Rate (pps)

<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)

10800

OFF Time (Seconds)

10800

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NOTE: orders placed AFTER 5:00pm Eastern Daylight Time will be shipped the next business day. Any orders placed after 5:00pm Eastern Daylight Time on Friday with Ground Shipping will not be shipped out until the following Monday.

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