Vissco Healthcare Private Limited Stim3 Russian Stimulator Instruction Manual

Vissco Healthcare Private Limited Stim3 Russian Stimulator

Precautionary Instructions

The precautionary instructions found in this section and throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definition of these symbols are as follows;

CAUTION-

Text with a “CAUTION” indicator will explain possible Safety infractions that could have the potential to cause minor to moderate injury or damage to equipment.

WARNING-

Text with a “WARNING” indicator will explain possible Safety infractions that will potentially cause serious injury and equipment damage.

NOTE :- Throughout this manual “NOTE” may be found. These Notes are helpful information to aid in the particular area of function being described.

CAUTION

• Read, understand and practice the precautionary an operating instructions. Know the limitations and hazards associated with using any electrical stimulation device. Observe the precautionary and operational decals placed on the unit.
• DO NOT operate the unit in an environment of short-wave diathermy use.
• DO NOT use sharp objects such as a pencil point or ballpoint pen to operate the buttons on the control panel as damage may result.
• This unit should be operated, transported and stored in temperatures between 59°F and 104° (15° C and 40°C), with Relative Humidity ranging from 30%-60%.

WARNING

• This device should be kept out of the reach of children.
• Care must be taken when operating this equipment around other equipment. Potential electromagnetic or other interference could occur to this or to the other equipment. Try to minimize this interference by not using other equipment in conjunction with it.

Instruction Manual 3 STIM

INSTRUCTIONS FOR THE USER OF ELECTROTHERAPY

Please read this instruction manual carefully before using STIM
because it is unsafe to start using the device before reading the whole
manual.

CAUTION : USA Federal law restricts these devices to sale by, or on order of a physician or licensed practitioner. This device should be used only under the continued supervision of a physician or licensed practitioner.

Intended Use

ALL STIM provides desired stimulating currents, which can be chosen by clinicians for the following treatment therapies:

A ) Interferential Current Stimulation and TENS is indicated for

1. Symptomatic relief and management of chronic and intractable pain.
2. Adjunctive treatment in the management of post-surgical and posttraumatic, acute pain Conditions.

B ) Electrical Muscle Stimulation (EMS or Russian) is indicated for:

1. Relaxation of Muscle spasm
2. Prevention of Retardation of disuse atrophy.
3. Increasing local blood circulation.
4.  Muscle re-education.
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
6. Maintaining or increase range of motion.

Contraindications

The STIM should not be used on patient with cardiac demand pacemaker.

Warnings

• The long-term effects of chronic electrical stimulation are unknown.
• Stimulation should not be applied over the carotid sinus nerves, particular in patient with known sensitivity to the carotid sinus reflex.
• The electrode should not be applied over the neck or mouth, or anywhere else on the head. If stimulation is applied over the neck or  mouth especially, severe spasm of the laryngeal and pharyngeal muscle may occur and the contraction may be strong enough to close the airway or cause difficulty in breathing.
• Stimulation should not be applied transthoracic ally in that the introduction of electrical current into the heart may cause cardiac arrhythmias.
• Stimulation should not be applied over swollen, inflected, or inflamed areas or skin eruption, e.g. phlebitis, thrombophlebitis, varicose veins, etc.
• Stimulation should not be applied over, or in proximity to, cancerous lesion.

Precautions

• Safety of the STIM for use during pregnancy has not been established.
• Caution should be used for patient with suspected or diagnosed heart problems.
• Caution should be used for patients with suspected or diagnosed epilepsy.
• Caution should be used in presence of following:
• When there is a tendency of hemorrhage following acute trauma or fracture.
• Following recent surgical procedures when muscle contraction may disrupt the healing process.
• Over the menstruating or pregnant uterus.
• Over area of the skin which lack normal sensation.
• Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium. The irritation can usually be reduced by using an alternate conductive medium or alternate electrode placement.
• Stimulation settings should be based on the guidance of the prescribing practitioner. Electrode placement should be based on  the guidance of the prescribing physician.
• STIM should be kept out of the reach of children.
• The STIM should be used only with the lead wires and electrodes recommended for use by the manufacturer.
• The STIM should not be used while driving, operating machinery, or during any activity in which involuntary muscle contraction may put the user at undue risk of injury.
• Ensure the intensity is adjusted slowly and smoothly and not increased beyond the patient’s tolerance.
• While treatment Do not lift electrodes off the skin without the intensity being turned down to zero first.
• Also be aware of the skin’s resistance as this may suddenly drop causing the intensity to increase.

Adverse Reactions

Skin irritation and burns beneath the electrodes have been reported with use of this device.

DESCRIPTION

STIM is a Portable Neuromuscular Electrical Stimulator which delivers Interferential Stimulation (IFT), Electrical Muscle Stimulation (EMS) and Transcutaneous Electrical Nerve Stimulation (TENS)  through two outputs. The unit, beautifully designed with the Membrane panel, provides easy touch entry for treatment selection, and allows treatments to be specifically tailored to the needs of the patients. Being battery or adaptor operated with an attractive sturdy ABS enclosure, 3 STIM can be carried around anywhere in clinic as well as for offsite treatments.

Features:

a ). STIM uses rechargeable battery and adaptor system and makes it much more safe and effective.
b ). Micro-computer controlled and digital displays guide through the programming.
c ). ABS molded ergonomically designed, since STIM is small in size, hence it can be used repeatedly and at home also.

ACCESSORIES

Carbon Electrodes 2” Elastic Belts 36” Elastic Belts 18”

Conductive Gel

| 08
| 08
| 01
| 04
| 100 ml
3.| Adaptor| 01
4.| Instruction Manual| 01
5.| Carry Bag| 01
6.| Pen Electrode(Optional)| 01

TECHNICALSPECIFICATIONS

Total No. of Outputs Two/ Four
Stimulation Types EMS, IFT, and TENS
Waveform EMS: Symmetrical Biphasic Square Wave
IFT : Symmetrical Sine Wave
TENS: Symmetrical Biphasic Square Wave

EMS Conventiona l: Selectable Pulse Width
(200-450µS), Pulse rate (001-150 Hz),

Russian : Medium Freq.2500Hz/50Hz
Sinewave

IFT ( 5000 Hz) L OW : Sweep 1-10 Hz (1±4Hz to 10±4Hz)

HIGH : Sweep 80 -150 Hz (80±25Hz to 150±25Hz)

WIDE: Sweep 1 -250 Hz (1±25Hz to 250±50Hz)

FIXED: Selectable beat frequency (10,

20, 30 …200 Hz) in steps of 10 Hz.

(Inbuilt Vector Stimulation from100% –

0 % a n d t h e n f r o m 0 % – 1 0 0 % i n V e c t o r period of 22 Sec.)

TENS Conventional : Selectable Pulse Width

(50-250µS), Pulse rate (1-150 Hz).

Burst: Preset Pulse Width (250µS) and preset Pulse Rate (50Hz).

Burst of 7 pulses followed by 2 seconds rest period.

Modulation: Selectable Pulse rate (1-150Hz.).

Preset Pulse Width modulation Width varies in between 100-200µS over a fixed period.

Note: Contraction / Relaxation and Ramp settings are not available.

Treatment Time 1 to 60 minutes

Power 4X1.2V Ni-Mh, Rechargeable battery &

Output Voltage IFT : 50 V pp @ 500 Ohms Load (±10%)

EMS/Russian/TENS : 50 Vpp @500 Ohms Load (±10%)

Output Current IFT :100mApp

EMS/Russian/TENS : 100mApp

Note: All the parameters have ±10% tolerance.

INDICATORS & CONTROLS

FRONT PANEL

1. EMS
   For selection of Electrical Muscle Stimulation modes

2. IFT
   For selection of Interferential Stimulation modes
   a ) LOW b) HIGH c) WIDE d) FIXED

3. TNS
   For selection of TENS Stimulation modes

4. Output Keys
   a ) Conventional b) Burst c) Modulation
   To select the desired channel (1/ 2/ 3/ 4)

5. TIME KEY
   To set the Treatment Time
   To Start/Stop the treatment in all the channels

7 &9 Increment / DECREMENT   KEYS
To increase and decrease the values of Pulse Width and Pulse Rate (in EMS/TNS), fixed beat frequency (in IFT), Contraction/Relaxation Time, Treatment Time, Ramp up/down and % power.

ENTER/LOCK KEY

TOP VIEW

 POWER INPUT SOCKET

To insert the adaptor pin (when the device is working on adaptor)

ROCKER SWITCH

To switch the unit ON/OFF

 OUTPUT SOCKETS FOR CHANNEL NO. 1, 2, 3 & 4

To connect the 4 core lead wires to the device. Output A is dedicated to Channel 1 and 2 while Output B is dedicated to Channel 3 and 4.

Note: STIM Two Channel Stimulator has only one output socket.

HOW TO USE STIM

Before You Start

1. The STIM may be susceptible to interference originating from short-wave diathermy units operating in closed proximity to 3 it. Avoid operating the STIM adjacent to and simultaneously with operating short-wave devices.
2. Do not use sharp objects to operate the membrane panel switches. If the tough outer layer of the membrane is broken, moisture may leak into the switches resulting in switch failure.

Preparation

• Use only the lead wires and electrodes provided by the manufacturer with the unit.

• We strongly encourage careful maintenance of the electrodes.
  This includes the lead wires as well as the pads. Worn cables and / or poor pads or the wrong sized pads can have a significant impact upon treatment results.

• For safe operation of STIM , review contraindications and precautions before positioning the electrodes.

• The patient should be suitably positioned ensuring maximum comfort and suitable exposure of the part for the application of Interferential Current.

• The therapist should first mark the points where electrodes are to be placed and then apply them accordingly.

• Make sure that the entire surface of the electrode is in firm contact with the skin on the treatment area.

• Reusable electrodes must not be used for a time longer than recommended by the manufacturer.

• Cleaning of skin is essential before electrode placement to eliminate any impairment to current conduction such as an oily or dry surface, or excessive hair coverage. Shaving may be   necessary depending upon the density of hair coverage.

• Failure to provide for maximum current conduction efficiency could result in skin irritation relating to an increase in current density at the electrode site.

• The patient should be explained about the subjective sensory motor feeling that he/she will experience. The patient should experience a sensation of deep, sufficiently strong but pleasant  vibrations at rhythmical frequencies and a pleasant tingling sensation.

• Patient should be explained to the therapist immediately, if any unpleasant sensation or any other discomfort. The therapist should promptly but gradually reduce the intensity to zero as and when patient reports of any discomfort.

Operating Instructions

Switching ON the Device

1. Insert the adaptor pin into the power input socket (if the device is being operated on adaptor).
2. Switch ON the device Using the rocker switch provided on top of the unit
   Note: The digital display will show

After 5 seconds the display will fade and then show:

Check Battery

If battery is poor, the display will show:

Recharge the batteries and then start the device again. Ensure that the batteries are fully charged.

Programming

Programming of this Unit consists two sections:

1. Selection of Waveform Stimulation
2. Locking the Stored Program

SELECTION OF WAVEFORM STIMULATION

PART-A- ‘EMS’

1. Press “EMS” key to select Conventional or Russian
   A) If Conventional Mode is selected the display will show:
   

2.  Press ENTER key
   Note: The Display will show

Indicating the preset Pulse Width 400µS

3. Use and ‚ keys to select the desired Pulse Width. (Selectable from 200 to 400 µS)
4. Press ENTER key
   Note : The Display will show:

Indicating the preset Pulse Rate 70 Hz

5. Use and ‚ keys to select the desired Pulse Rate. (Selectable from 001 to 150 Hz)
6. Press ENTER key

Indicating the preset Contraction Time 10 seconds.

7. Use and ‚ keys to select the desired Contraction Time
   (Selectable from 01 to 60 sec.)

8. Press ENTER key,
   Note: The Display will show:

Indicating the preset Relaxation Time 15 seconds

9. Use and ‚ keys to select the desired Relaxation Time (Selectable from 00 to 60 sec.)
10. Press ENTER key.
    Note : The Display will show:

Indicating the preset Ramp UP and Down time 02 seconds.

11. Use and ‚ keys to select the desired Ramp Up and Down time (Selectable from 1 to 10 sec.)
12. Press ENTER key.
    Note: The Display will show:

Indicating that EMS mode has been programmed and is ready for the treatment with default time of 30 min. This user can start treatment here. To change the treatment time, refer to Part D of this section.

B) If Russian Mode is selected the display will show:

1. Press ENTER key.
   Note: The Display will show.

Indicating the preset Contraction Time 10 seconds.

2. Use and ‚ keys to select the desired Contraction Time (Selectable from 01 to 60 sec.)

3. Press ENTER Key
   Note :The Display will show:

4. 4. Use and ‚ keys to select the desired Relaxation Time (Selectable from 0 to 60 sec.)

5. Press ENTER key.
   Note :The Display will show:

Indicating the preset Ramp UP and Down time 02 seconds.

6. Use and ‚ keys to select the desired Ramp Up and Down Time (Selectable from 1 to 10 sec.)
7. Press ENTER key.
   Note :The Display will show:

Indicating that EMS mode has been programmed and is ready for the treatment with default time of 30 min. This user can start treatment here. To change the treatment time, refer to Part D of this section.

PART-B- ‘IFT’

1. Press “IFT” key to select any of these modes:
   (A) Low
   (B) High
   (C) Wide
   (D) Fixed

(A) If IFT Low is selected the Display will show:

1. Similarly, press “IFT” Key again to select High (B) and Wide (C)
2. Press Enter Key.
   Note: The Display will show:

Indicating that IFT mode has been programmed and is ready for the treatment with default time of 30 min. This user can start treatment here. To change the treatment time, refer to Part D of this section.

( D ) If “Fixed” is selected (Inbuilt Vector Stimulation from 100% – 0% and then from 0% – 100% in Vector period of 22 Sec.) the Display shows:

Indicating Interferential Stimulation with Beat Frequency of 10 beats per second (bps.)

1. Use and ‚ keys to select the beat frequency (Selectable from  10 – 200 bps. in step of 10).
2. Press ENTER Key.
   Note:   The Display will show:

Indicating that IFT mode has been programmed and is read for the treatment with default time of 30 min. This user can start treatment here. To change the treatment time, refer to Part D of this section.

PART-C- ‘TENS’

1. Press “TNS” key to select any of these modes:
   ( A ) Conventional
   ( B ) Burst
   ( C ) Modulation
   ( A ) If Conventional is selected the Display will show:

2. Press ENTER Key.
   Note: The Display will show:

Indicating preset Pulse Width of 250µS.

3. Us and ‚ keys to select desired Pulse Width. (Selectable from 50 to 250 microseconds)
4. Press ENTER Key.
   Note: The Display will show:

Indicating preset Pulse Rate 70Hz.

5. Use and ‚ keys to select desired Pulse Rate. (Selectable from 001 to 150 Hz)
6. Press ENTER Key.
   Note: The Display will show:

Indicating that TENS mode has been programmed and is ready  for the treatment with default time of 30 min. This user can start treatment here. To change the treatment time, refer to Part D of this section.

( B ) If BURST is selected: the Display shows:

1. Press ENTER Key.
   Note :The Display will show:

Indicating that TENS mode has been programmed and is ready for the treatment with default time of 30 min. This user can start treatment here. To change the treatment time, refer to Part D of this section.

( C ) If MODULATION is selected the Display shows:

1. Press ENTER Key.
   Note : The Display will show:

Indicating preset Pulse Rate 70 Hz.

2. Use and ‚ keys to select the desired Pulse Rate. (Selectable from 001 to 150 Hz)
3. Press ENTER Key.
   Note: The Display will show:

Indicating that TENS mode has been programmed and is ready for the treatment with default time of 30 min. This user can start treatment here. To change the treatment time, refer to Part D of this section.

PART-D- TREATMENT TIME SELECTION

1. Press TIME Key.
   Note :The display will show:

Indicating the preset Treatment Time 30 Minutes.

2. Use and ‚ keys to select the desired treatment time (Selectable from 1 to 60 minutes).
3. Press ENTER key
   Note :The Display will show:

Indicating that unit is ready to start the treatment.

LOCKING THE STORED PROGRAM

LOCK (OPTIONAL)

After the treatment parameters are selected, up to READY MS/IF/TN, press “ENTER/LOCK” key once, Press it again (within 3  seconds) and keep for 5-6 seconds to lock the parameters. The Display will show.

Indicating that treatment is locked by the clinician. Now the patient can take the prescribed treatment repeatedly by the following steps in “Start Treatment “section of this manual.

When the parameters are locked the user can only turn the unit On/Off and change the intensity (No other key will work).

UNLOCK

Press “ENTER/LOCK” key once, press it again (within 3 seconds) and keep for 5-6 seconds to unlock the parameters.

The display will show.

Start Treatment

The user can start the treatment when either of the following messages is displayed:

START

To start the treatment:

1. Insert the electrode cables into the Output Socket.
2. Place the electrodes on desired body area and secure them to the skin.
3. Press “Start/Stop” Key.
   Note: the LCD display will show:

Indicating 00 intensity (% power) at Channel 1.

4. To start the treatment for Channel 2, 3 or 4, press the respective Output Keys.
5. Increase the intensity to desired stimulation by pressing the Increment Key.
   Note : During the treatment after every minute, the display will show.

Where – – indicates the Mode selected and **indicates the balance treatment time.
When Treatment Time is over, display will show:

6. Take off the electrodes and place them back on the backing sheet provided by the manufacturer. Store the electrodes in a resealable pouch.
7. Press the rocker switch to turn OFF the device.
   Note:
   RECHARGE THE BATTERY: After the treatment is over please
   DO NOT FOR GET to recharge the battery for the next treatment.

IMPORTANT : At any time if the power is felt too intense, lower down by pressing the Decrement ‚ Key.

AINTENANCE

Cleaning

• The soiled unit should be cleaned with a damp cloth.
• Follow the care of electrodes as indicated on the package.
• For routine cleaning of the electrode cables use soap and water. Thoroughly dry after cleaning.

Warning

• Do not pull out cables.
• Electrode wires should be kept loosely winded or breakage may occur.

Storage

• Keep the unit properly covered, when not in use. This will help to keep out of dust.
• Make special space to keep the unit, after the treatment is over.
  Caution : Do not store the unit in a damp environment. Dampness may affect the device and cause rust.

Electrodes Care

• After using any of these electrodes, grasp the corner of the electrode and gently remove it from your skin.
• Do not pull on the electrode wire connection.
• Reapply the release liner to the adhesive side of the electrode. Store the electrode in a resealable pouch or plastic bag.
• To prolong the life span of electrodes, remoisten them by applying a few drops of tap water when they show signs of drying out or losing their adhesives. Apply the water with your fingertip.
• After repeated usage, reusable electrodes begin to lose their a adhesives and therefore deliver less stimulation and shorten battery life. Replace reusable electrodes as needed.

Battery Replacement

To replace the battery

1. Turn OFF the device.
2. Open the cover for the battery compartment provided at the back of the device. This exposes the battery for removal.
3. Replace the battery or recharge it.
4. Put the new/ recharged properly into the battery compartment.
5. Fix the cover back onto the device correctly to protect the battery.

TROUBLE SHOOTING

If your STIM unit does not seem to be operating correctly 3 refer to the chart below to determine what may be wrong, Should none of these measures correct the problem, the unit will need servicing.

or apply sufficient
Electrode conduction Is low/ Lead wire is worn out.| Change electrodes/ Change electrode wires.
Skin irritation at electrode placement site| Improper contact/ Gel dried up.| Wet or change the electrode.
Sudden high intensity while increasing amplitude.| Increasing amplitude too fast.| Increase amplitude slowly giving  time to patient to indicate his comfort.
Unit doesn’t switch ON.| Battery too weak or not connected properly.| Replace battery with a new one

or connect properly.

COMPLIANCE OF TREATMENT TIME (Only for Clinicians)

COMPLIANCE TIMER:

Information Displayed

a. CN XXXXX: Number of time the “Start/Stop” key is pressed. We will call it Compliance Number (shown as CN XXXXX).
b. CT XXXXX: Total time instrument is used. We will call it Compliance Timer (shown as CT XXXXX). 05 Minute of treatment time is equal to one unit. That is if display shows CT 00010 it  indicates that the total treatment taken from the instrument is 50 minutes (10 x 5). Please do note that the compliance timer records value in multiples of 5 only.

How to access the Compliance Number and Timer?

1. Ensure that the unit is not in middle of a treatment or being programmed for one. Also make sure that the instrument is not locked.
2. Press Time Key and release it immediately.
3. Immediately press “Start/Stop” key and release it.
   Note: The display will show

Indicating that the total number of times the treatment has been started (for minimum 5 minutes).
The display will continue to show the above messages for at least 5 times.

How to reset (erase) the Compliance timer and Compliance Number?

a. When message CN XXXXX or CT XXXXX are being displayed press “Enter key” , keep it pressed for 3 -4 seconds and release it.
b. The display will show CT00000followed by CN 00000.
c. Your compliance timer and number have been reset.

WARRANTY

This product warranty extends to the original consumer /purchaser of the product.

Warranty Duration

This product is warranted to the original consumer for a period of one (1) year from the original purchase date.

Warranty Coverage

This product is warranted against defective materials or workmanship. This warranty ceases if the product has been damaged by accident, in shipment, unreasonable use, misuse, neglect, improper service, commercial use, repair by unauthorized personnel or cause not arising  out of defect in materials or workmanship. This warranty does not extend to any units which are used in violation furnished by manufacturer, or to units which have been altered or modified, or to  damage to products or parts there of which have the serial number removed, altered or defaced or rendered illegible. The warranty doesn’t cover normal wear & tear or replacement of adaptor, electrode cables, electrode & other accessories.

Warranty Disclaimers

This warranty is in lieu of all warranties expressed or implied and no representative or person is authorized to assume for manufacturer/ any other liable in connection with the sale of our products. There shall be no claims for defects or failure of performance or product failure/ any  theory of tort, contract or commercial law including, but not limited negligence, gross negligence, and strict liability, breach of warranty  and breach of contract. Some states do not allow the exclusion or limitation of implied warranties or consequential damages, so the above limitations may not apply to you.
Manufacturer is not responsible or liable for indirect special or consequential damages arising out of or in connection with the use performance of the product or other damage with respect to loss of property or loss revenues or profit.

Legal Remedies

This warranty gives you specific legal rights, and you may also have other rights that vary from state to state.

Warranty Performance

During the above one-year warranty period, a product with a defect will be repaired or replaced with a reconditioned comparable unit at distributor’s option when the product is returned to the distributor. The  repaired or replacement product will be in warranty for the balance of the one-year warranty period and an additional one-month period. No charge will be made for such repair or replacement.

Consumer Service

For in warranty service for a product covered under the warranty period, no charge is made for service and return postage. Please return the product insured, packed with sufficient protection, postage insurance, prepaid to the address. Customer’s duty/brokerage fee, if any, must be paid by the consumer.

Out Of Warranty Service

There will be charges rendered for repairs made to the product after the expiration of the aforesaid one (1) year warranty period, after purchaser is advised appropriately.

The distributor cannot assume responsibility for loss or damage during shipment. For your protection, carefully pack the product for shipment and insure it with the carrier. Ensure that you return the unit and accessories related to your problem and also that you indicate full return address. Also send a copy of sales receipt or other proof of  purchase to determine warranty status. C.O.D. shipments cannot be accepted.

List of Accessories: (in case of replacement)

CUSTOMER SUPPORT

Please send warranty information for replacement of any accessory is needed to following address:

JOHARI DIGITAL HEALTHCARE LTD.

G-582-584, EPIP, BORANADA, JODHPUR
342012 (RAJ.) INDIA
TOLL FREE: 1800-102-8684 | Email : [email protected]

IMPORTANT

The contents of this document is solely available for informational  purpose only and are illustrative in nature and must not be interpreted to be exhaustive and final & we reserve exclusive rights to change or modify the contents at any stage without any prior intimation.
Subject to exclusive Jurisdiction to Courts in Jodhpur only

Register your product through this link: /product registration
Important: Warranty is not valid if you do not
activate your warranty within 15 days of purchase.

References

• Medical Device Manufacturing Company - Johari Digital Healthcare Ltd
• Home - Vissco Healthcare Private Limited.

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