EMSI Flex-TENS Electrical Stimulation Unit Instruction Manual

EMSI Flex-TENS Electrical Stimulation Unit Instruction Manual

CAUTION
Federal law requires a prescription from your physician before use of this product.

Intended Use

The EMSI Flex-TENS® is designed for the following:

TENS- Transcutaneous Nerve Stimulation

• Symptomatic relief of chronic intractable pain
• Post traumatic and post surgical pain relief

To The Patient
Please read this operating manual carefully before using the device. The instruction on the following page will show you how to use and care for your device in the general manner. You should be particularly familiar with the prescription information and precautions before proceeding. You should consult with your clinician if you have specific questions or problems regarding the use of your device.
CAUTION: Federal law restricts this device to sell by or on the order of a physician.

Contraindications

1. Any electrode placement that applies current to the carotid sinus (front of neck) region.
2. Any electrode placement that causes current to flow transcerebrally (through the head).
3. Contraindications continued
4. Any use of this device on patients who have any kind of implantable devices.
5. The use of this device whenever pain syndromes are undiagnosed, until etiology is established.

Warnings

1. The long-term effects of chronic electrical stimulation are unknown.
2. Stimulation should not be applied over the carotid (front of neck) sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex.
3. Stimulation should not be applied over the front of neck or mouth.
4. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing.
5. Stimulation should not be applied transthoracically (through front and back of chest) in that the introduction of electrical current into the heart may cause cardiac arrhythmias.
6. Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
7. Stimulation should not be applied over, or in proximity to, cancerous lesions.
8. For external use only.
9. Do not use device on the eye area. 9. This device should be used only under the continued supervision of a physician.
10. Safety for use during pregnancy on delivery has not been established.
11. Electronic equipment such as ECG monitors and ECG alarms may not operate properly when electrostimulation is in use.
12. Apply the electrodes to clean, dry and unbroken skin only.
13. This device should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.
14. This device should be kept out of the reach of children.
15. This device is not effective for pain of central origin, including headaches.
16. This device has no curative value.
17. TENS is a symptomatic treatment, and as it suppresses the sensation of pain which would otherwise serve as a protective mechanism.

Precautions

1. Caution should be used for patients with suspected or diagnosed heart problems.
2. Caution should be used for patients with suspected or diagnosed epilepsy.

Precautions continued

1. When there is a tendency to hemorrhage following acute trauma or fracture.
2. Following recent surgical procedures when muscle contraction may disrupt the healing process.
3. Over the menstruating or pregnant uterus.
4. Over areas of the skin which lack normal sensation.
5. Some patients may experience skin irritation of hypersensitivity due to the electrical stimulation or electrical conductive medium.
6. The irritation can usually be reduced by using an alternate conductive medium, or alternate electrode placement.
7. Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner.
8. This device should be used only with the leads and electrodes recommended for use by the manufacturer.
9. Isolated cases of skin irritation may occur at the site of the electrode placement following long-term application.
10. Effectiveness is highly dependent upon patient selection by a person qualified in the management of pain patients.
11. If the stimulation levels are uncomfortable or become uncomfortable, reduce the stimulation amplitude to a comfortable level and contact your physician if problems persist.

Adverse Reactions

1. Possible skin irritation or electrode burn under the electrodes may occur.
2. Possible allergic skin reaction to tape or gel may occur.
3. Electromagnetic Disturbances: There is a possibility that radio signals from high-frequency transmitters, e.g. mobile phones or similar mobile radio equipment, airport security systems, or metal detection devices (which themselves conform to the EMC regulations), may influence the proper functioning of the device if such equipment is operated in close proximity and with relatively high transmitting power.

The Flex-TENS® meets EMC requirements and is designed in such a way, that under normal conditions, there is no risk of malfunction caused by electromagnetic interference. However, in the case of signals from high frequency transmitters, the risk of electromagnetic incompatibility when operated in close proximity to electronic apparatus cannot be totally ruled out. In unusual circumstances, unintended functions of the Flex-TENS* could be initiated, possibly giving rise to undesirable risks for the patient or user such as a surge in energy level or ineffective treatment parameters.

Unit Description

• ON/OFF Button: Turns the unit ON and OFF.
• Amplitude Controls: Controls the “INTENSITY” level of stimulating pulses.
• MODE Button: Choose the TENS stimulation modes.
• SET Button: Set the pulse width, pulse rate.
• TIMER Button: Sets the timer.
• INCREASE & DECREASE Button: Increase and decrease pulse width, pulse rate and choose the timer.
• LOCK/UNLOCK Button: Locks or unlocks the unit.
• Symmetric/Asymmetric Button: Choose symmetric or asymmetric waveform.

Unit Description continued

Specifications

Symmetric

| Output| **
Peak Pulse Output| **
Level| Level 1~Level 20: E ach level increases ± 1 35V

Asymmetric

| Output| **
Peak Pulse Output| **
Level| Level 1: 2.7V

Level 2~L evel 20: Ea ch level increases 1.95V

Pulse Width:| Variable, 50~300 µs
Pulse Frequency:| Variable, 2~ 150 Hz

All values + or – 10%

Specifications continued

Patient Compliance Timer| Operation count: record of 60 sets (min. , max with 999 mins. Operation total time: max with 999 hrs.
---|---
Operation ambient:| Temperature range: 10°C ~ 35°C Humidity range: 20 ~ 90%RH
Storage & transportation:| Temperature Range: 0°C ~ 70°C Humidity Range: 20 ~ 90%RH
Timer:| 5~ 90 minutes auto-shutoff or Constant

Stimulation Mode Descriptions
The stimulation mode offers a variety of stimulation modes. It is adjustable by pressing on the “MODE” button. Be sure that when adjusting these stimulation modes, the intensity output controls should be set to the minimum output first.

TENS

ered per second. Positive pulse and negative pulse iterate continuously at fixed 100Hz. Pulse width are adjustable from 50~300µs

Normal (N)

| are not automatically interrupted nor varied in any way. In this mode, the pulse rate mode is quite versatile because it may be applied with a variety of rate and width settings.

Modulated Rate & Width (MRW)

| ****

massage-like sensation. It’s believed that nerves can become accustomed to, or “ac- commodated” to the same electrical stimulus after a period of time and thus would

produced to o er a variety of di erent electrical stimulation, thus preventing nerve accommodation so that less intensity is required for long and e ective treatment. In this mode, during the beginning of 0.5 second period, the WIDTH decreased to 50% of its original setting and then during the next 0.5 second period, the RATE is

Stimulation Mode Descriptions continued

always increasing while the pulse width is

to 67% of setting (intensity equal to setting). Total cycle time is 6 seconds. Pulse rate (from 2 to 150Hz) and pulse width (from 50 to 300µs) are fully adjustable.

Bi-Pulse (Bi-Pulse)

| ****

pulse rate of Channel 1 is fixed at 4Hz) while delivering 100 pulses per second to Channel 2 (i.e. the pulse rate of Channel 2 is fixed at 100Hz). Stimulation

vertical line. Pulse width (from 50 to 300 µs) is fully adjustable.

Instructions For Use
NOTE: Always read this instruction manual before use.

PREPARATION FOR USE
Check Battery
Proceed to insert battery pack into the battery compartment. BE SURE TO MATCH THE POSITIVE AND NEGATIVE ENDS OF THE BATTERY PACK TO THE MARKINGS IN THE BATTERY COMPARTMENT OF THE UNIT.
NOTE: Before first and consequent uses, charge battery using the supplied battery charger. To charge: Plug male end of charger to the socket located on the right side of the LCD screen.  Make sure the plug fits snugly into the socket. PERMANENT DAMAGE MAY OCCUR IF FRCE IS USED TO PLUG THE MALE END OF THE CHARGER INTO THE SOCKET. A green indicator light will illuminate and alternately flash as it is being charged. When charging is done (usually 3-4 hours on a fully discharged battery), a green steady light will illuminate. Typical charge may last 2 hours of use depending on frequency and intensity of treatment.
NOTE: The device will NOT work if the charger is plugged into the device. Nor will the device work if the charger plug is plugged into an outlet. Once charged or not in a charging mode, disconnect the plug from the device. Use of unapproved charger (not issued by EMSI) may cause damage to device and will void any warranty.

CONNECTING THE STIMULATOR
Connect electrodes to lead wires: Insert the lead wire connector into electrodes connector (standard 0.08 inch female connection). MAKE SURE THAT NO BARE METAL OF THE PINS IS EXPOSED

Instructions For Use continued
Caution

1. Always use 1.5″ x 1.5″ (16cm?) electrodes or larger.

2. The Flex-TENS® is compatible and recommended for use with EMSI electrodes (or comparable). Always use electrodes and leadwires that came with the unit. Using other electrodes and leadwires may render the unit non-operable, ineffective, and void the warranty.

3. Connect lead wires to unit: Before proceeding to this step, be sure the unit is turned OFF. Holding the insulated portion of the lead wire connector, insert the angled-“I” plug into the receptacle on the top of the main unit. Please ensure the lead wires are inserted securely. The unit has two output receptacles which are controlled by Channel 1 and Channel 2 Amplitude Control buttons on the front of the unit.

4. You may choose to use one channel with one pair of lead wires or both channels with two pairs of lead wires.
   Caution: Always use leadwires that came with the unit. Using other leadwires may render the unit non-operable and void the warranty.

5. Place electrodes on skin: Before applying electrodes, be sure that the skin surface over which electrodes are placed is thor oughly cleaned and dried. Apply electrodes to the exact site indicated by your physician following the instruction included with the electrodes labeling. Make sure that the electrodes are placed firmly to skin and make good contact between the skin and the electrodes. Place the electrodes over the skin; attach them properly, firmly and evenly.

6. Treat as directed by prescribing clinician.

7. Turn Unit Off: Press the “ON/OFF” button to turn unit off. Then unplug the electrode lead wires, grasping them by the plug, not the cord. If treatment will be resumed shortly the electrodes may be left on the skin. When the electrodes are removed, clean the skin thoroughly with mild soap and water. If there is skin irritation, consult your medical professional.
   Caution: When the timer runs out, the unit will turn off automatically and you are not required to press the “ON/OFF” button. Unit will also turn off automatically after 5 minutes if no activity is made when the unit is initially turned on.
   NOTE: This device is safeguarded with a Locking mechanism to avoid possible mishandling when treatment is in session. The user can manually “Lock” the settings for the duration of the treatment by pressing and holding the “key” button for 3 seconds (a beep (if enabled) will confirm device is locked). The device also automatically “locks” if no treatment button is pressed for 1 minute. Once locked, other than the power button, no buttons are active. To disable the “Lock” during treatment session for adjustment or stoppage, press and hold the “key” button for 3 seconds (a beep will confirm device is unlocked). The user can then adjust amplitude, settings, etc.

SPECIAL CARES IN OPERATING

• Clean and dry the skin surface of the body area to be treated.
• Inspect the electrode cords and electrode pads for wear. If they are not in good condition, they 10.0 | Instructions For Use continued should be replaced. If they are acceptable, then insert the cord pins into each electrode pad.
• Electrodes are for single patient use, and are to be used in accordance with the labeling provided with the electrodes. Electrodes should not be used for multiple patients.
• Make sure the electrode pads are firmly fixed in place to obtain effective conduction.
• Use the electrode sites recommended by your prescribing physician.
• Increase the output level SLOWLY to that recommended by your clinician.
• Usually, that will mean increasing intensity until you can feel the tingling sensation (high pulse rates) or pulsing sensation (low pulse rates) of the stimulation. Your prescribing clinician will tell you how far they wish you to turn up the intensity.
• If at any time the electrical stimulation begins to feel uncomfortable, reduce the stimulation amplitude to a comfortable level and contact your physician if the problem persist.
• The possibility of electromagnetic disturbance from other equipment in or outside your home exist.
• Use caution in using electrical stimulation in situations which may have a potential high frequency transmitter such as in close proximity to mobile phones in use, airport security systems, or hand held detectors.
• If you are finished using the unit (prior to timer finishing), turn the device off and the LCD display will disappear. This will conserve battery life. You may now remove the electrode pads from your body.

Instructions For Use continued
Operation Procedure Chart

Patient Compliance Timer
The patient compliance timer can memorize 60 sets of operation records; the total record time is 999 hours. The patient compliance timer is accessible only when the unit is turned off. Press and hold “Mode” button, then press the “ON/OFF” button simultaneously to initiate the patient compliance timer.

Individual treatment time
Press “INCREASE” button (triangle button) or “DECREASE” button (inverted triangle button) to scroll through the records of treatment times. Press and hold “Set” button for 3 seconds to delete the displayed record. After the displayed record is deleted, the unit will acknowledge with an audible response “Bi”.

NOTE
If the treatment time is under one minute, it will not be recorded. For example, if your treatment time is 10 minutes and 30 seconds, the patient compliance timer will record 10 minutes, not 11 minutes. The patient compliance timer will record up to 999 minutes for each treatment. Therefore, if you use the stimulator for over 999 minutes, it will record 999 minutes and the recorded time will flash to indicate the treatment time is over 999 minutes.

Cumulative treatment time
When initiating patient compliance timer, press “Mode” to shift the record of individual treatment time with the number of sessions to the record of cumulative treatment time. When showing the record of cumulative treatment time, there will be an “M” mark flashing on the screen. Press and hold “Mode” & “Set” button simultaneously for 3 seconds to delete all the records including individual treatment time record and cumulative treatment time record. The patient compliance timer will keep the records even when the battery has no charge. Only when users press and hold “Set” or “Mode” & “Set”, the records will be deleted.

Principles of TENS Treatment
TENS, Transcutaneous Electrical Nerve Stimulation, is a method of applying controlled, low-voltage electrical stimulation to large, myelinated peripheral nerve fibers via cutaneous electrodes for the purpose of modulating stimulus transmission and relieving pain.
The tissues and cells of our bodies are always emitting electricity, which regulates the organs, nerves and muscle. TENS, utilizes both positive and negative poles of electricity conducted by electrodes and affixed to the surface skin to have electric currents stimulate the peripheral nerve fibers. TENS is believed to work by two different mechanisms. First, electrical stimulation of the fast- conducting nerve fibers can block/override a slow- conducting pain signal from being carried to the brain/spinal cord. If the signal is blocked, pain is not perceived. Secondly, the body has its own mechanism for suppressing pain. It does this by releasing non-addictive natural chemicals called endorphins in the brain which act as analgesics. TENS may activate this mechanism. The effectiveness of TENS treatment is not 100% for all pain syndromes. Experimentation with setting and electrode placement may be required for best results.

Care and Maintenance

Low Battery Indicator
When the low battery indicator flashes, the batteries should be recharged as soon as possible.

Cleaning:
Clean the housing by wiping with clean damp cloth only. To avoid corrosion, do not immerse in water. Do not store in direct sunlight or humid environments, i.e. Bathrooms.

Electrode Pad Disposal
Electrodes should not be used if they will no longer adhere firmly to the treatment area. Electrodes are single-use, and should not be used by more than one patient.

Troubleshooting

If your unit does not seem to operate correctly, refer to the chart below to determine possible causes. If none of these measures correct the problem, please contact a Customer Service Representative

function properly.

| Low Battery indicator flash.| None of LCD indicators illuminate.
---|---|---
1.  Check all control settings. Are they set to values prescribed by your medical professional?

2.  Are electrodes in proper position and adhering to the skin? See Section 10, Instructions for Use and the electrode manufactures instruction for applying the electrodes.

3.  Check lead wires. Be sure all connectors are firmly sealed. See Section 10, Instructions for Use and the electrode manufactures instruction for applying the electrodes.

4.  Replace cord set with another to check for broken wires.

|

Recharge battery pack

|

Recharge battery pack

If none of these measures correct the problem, please contact a Customer Service Representative.

WARRANTY

This product is warranted to the original consumer for a period of one (1) year from the original acceptance of this device. This product warranty extends only to the original consumer of the product. This product is warranted against defect or workmanship for this period. This warranty is voided if this product has been damaged by misuse, abuse, neglect, or otherwise used in a manner not suited or prescribed for this product. This warranty is voided with use of unapproved electrodes, lead wires, chargers, or batteries. This warranty does not cover what is considered to be normal wear and tear, replacement of batteries, lead wires, electrodes, and other accessories. EMSI reserves the right to honor/dishonor product warranty as it sees fit.
CAUTION: Federal law requires a prescription from your physician before use of this product.

3504 Cragmont Dr. Suite #100 | Tampa, FL 33619
P: 800.588.8383 | 813.931.2369 | F: 800.588.9282 | E: customerservice@wecontrolpain.com
Copyright 2016 by EMSI. All Rights Reserved. REV G

CAUTION
Federal law requires a prescription from your physician before use of this product

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