Zewa OTC TENS and EMS Spa Buddy Sport Tens Pain Therapy System Instruction Manual

Instruction Manual
Model: OTC TENS and EMS

**** Please keep this instruction manual safe for future use

INTRODUCTION TO OTC TENS and EMS

1. GENERAL DESCRIPTION
   The device is a battery-operated pulse generator that sends electrical impulses through electrodes to the body to reach nerves causing pain. Electrical impulses can be adjusted by changing the pulse width and rate. The strength is individually adjusted using the 2 channels. A slide button (button lock function) protects the device from accidental changes while in use.

2. EXPLANATION OF PAIN
   Pain is the body’s natural warning mechanism and is intended to prevent additional injury. Pain is important, as, without it, vital parts of our body might be injured or damaged without our knowledge. While ointments, drugs, or even surgery can be used to treat chronic pain, these are all utilized with varying degrees of success, as each individual patient and condition is different. TENS offers a unique alternative method of pain relief with no potentially harmful side effects.

3. WHAT IS A TENS/EMS COMBO UNIT
   A TENS / EMS combo unit is a 2 channel electrical stimulator with 2 stimulation modalities modes:
   TENS and EMS are explained in more detail below.

4. WHAT ARE TENS
   TENS, Transcutaneous Electrical Nerve Stimulator, is a battery-powered electrical unit that uses electrodes placed onto the skin over a painful area to deliver electrical impulses to the nerve fibers which lie underneath the skin surface. It provides pain relief by blocking pain signals to the brain via the spinal cord and peripheral nervous system. TENS also stimulates the production of endorphins, the body’s own “painkillers”.

5. COMMON APPLICATIONS FOR TENS
   Although dependent on your specific pain problem, TENS devices have been used successfully to treat many conditions, including:
   CHRONIC PAIN
   Cervical (Neck) – Amputation – Phantom Limb – Headache – Lower Back – Lumbago – Leg Pain –Arthritis
   ACUTE PAIN
   Post Operative – Muscle and Joint – Tendonitis – Fractures – Tennis Elbow

6. WHAT IS EMS
   EMS, Electrical Muscle Stimulation (also called Neuromuscular Electrical Stimulation/NMES), is a battery-powered electrical unit that uses electrodes placed on the skin to stimulate muscles.

7. COMMON APPLICATIONS FOR EMS
   Relax muscle spasms – Prevent or retard disuse atrophy – Increase local blood circulation – Reeducate muscles – Maintain or increase the range of motion.

INDICATIONS / CONTRAINDICATIONS/WARNINGS

Read the operation manual in its entirety before using the device.

INDICATIONS:
This device is intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities due to strain from exercise or normal household and work activities.
This device is also intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance and therefore may be considered a technique of muscle training.

CONTRAINDICATIONS

• Heart Disease – Use caution prior to using this device on patients suspected of having heart disease.
• Cardiac pacemakers – Do not use this device if you have a demand-type cardiac pacemaker or an implanted defibrillator.
• Trans cerebral stimulation – Do not apply electrical stimulation trans cerebrally (through the head).
• Epilepsy – Use caution for patients with suspected or diagnosed epilepsy when using this device.
• Carotid sinus – Do not apply electrical stimulation to the carotid sinus region of the neck.
• Unknown etiology – Do not use this device if pain symptoms are undiagnosed. Use only after the origin/cause of the pain has been determined by your doctor.
• Hemorrhages – Use caution when there is a tendency to hemorrhages, such as following acute trauma or fracture.
• Post-surgical use – Use caution following recent surgical procedures when muscle contraction may disrupt the healing process.
• Uterus – Do not use electrical stimulation during menstruation.
• Sensory loss – Do not use electrical stimulation where the sensory nerve damage is present by a loss of normal skin sensation.
• Skin irritation – If the patient experiences skin irritation due to electrical stimulation, stop using the device and consult the clinician. Irritation may be reduced by an alternative conductive medium or an alternative electrode placement. Isolated cases of skin irritation may occur at the site of electrode placement following long-term application.
• Adverse reactions – in addition to skin irritation, inflammation, and burns beneath the electrodes are potential adverse reactions. Follow directions carefully.

WARNINGS

• Pregnancy – The safety of using electrical stimulation during pregnancy or birth has not been established.
• Central origin pain – This device is not effective for pain of central origin (including headaches).
• Prescription – Use electrical stimulation only in the prescribed manner and for the prescribed reason.
• Symptomatic treatment – This device is a symptomatic treatment and, as such, suppresses the sensation of pain which would otherwise serve as a protective or warning mechanism of your body.
• Keep out of reach of children – Do not store or use this device near children.
• Electronic equipment – Electronic monitoring equipment (such as ECG and EKG alarms) may not operate properly when electrical stimulation devices are in use.
• Machinery operation – Never operate potentially dangerous machinery such as power saws, automobiles, etc. while using this device.
• Uncomfortable stimulation – If the stimulation levels are uncomfortable or become uncomfortable, reduce the intensity (amplitude) to a comfortable level. Contact your physician/clinician if this does not resolve the problem or if the problem persists or re-occurs at your next prescribed treatments session.
• Neck stimulation –Do not place electrodes across the neck or mouth. Severe spasms of the laryngeal and pharyngeal muscles may occur. This may be strong enough to close off the airway or cause breathing difficulty.
• Long-term effects – The long-term effects of chronic use of electrical stimulation are unknown.
• Damage from liquids – Do not immerse the stimulator unit in water or other liquids.
• High-frequency surgical devices – Simultaneous connection of a patient to a high-frequency surgical device while using this device may result in burns at the site of the electrodes and possible damage to the stimulator. Discontinue use before surgery.
• Microwave or radiofrequency sources – Operation in close proximity to shortwave or microwave therapy equipment may shut the stimulator off.
• Flammable – Do not use the device in an environment where flammable or explosive fumes may exist.
• External use – This device is for external use only
• Lead connection – Do not connect the lead wires to an alternating current (AC) power source or other equipment not

▲Danger
The device does not have AAP/APG protection.
Extreme hazard is possible if used in the presence of explosives, flammable materials, or flammable anesthetics. Caution should be used when applying the device to patients suspected of having heart conditions. Further clinical data is needed to show if there are adverse side effects on those with coronary disease.

CONTENTS

DESCRIPTION OF DEVICE AND FUNCTIONAL BUTTONS

1. ON/OFF Button: Turns the power on and off
2. SET Button: Used to select a mode system and program
3. TIMER Button: Used to program timer, 5 – 95 minutes or continuous (5-minute increments)
4. ↑ ↓ Buttons: Used to increase/decrease intensity level for CH 1 and CH 2
5. Sliding Switch: Lock/unlock buttons

The LCD Display:

1. Intensity level for Ch1 & Ch2 (30 levels)
2. Program
3. Mode system indicator
4. Timer (5-95 min. and continuous)
5. Symbol of button lock function
6. Low battery indicator

PROGRAM DETAILS

TENS

EMS

Program| Pulse width (uS)| Frequency (Hz)| Ramp up (sec)| On-Time (sec)| Ramp down (sec)| Off Time (sec)|

Mode type

---|---|---|---|---|---|---|---
P1| 300| 40~99| –| 2| –| 1| Synchronous
P2| 200| 4| –| –| –| –| Synchronous
P3| 300| 5| –| –| –| –| Synchronous
P4| 200| 99| –| 2| –| 1| Synchronous
P5| 200| 4~20| 2| 6| 2| 1| Synchronous
P6| 300| 50| 2| 5| 3| 10| Alternation

PREPARATION FOR USE

Insert batteries:
Your device operates with 3 AAA batteries. Please install batteries with polarities as indicated. Make sure the battery strip is placed below the batteries.
CAUTION: Never force a battery into the battery compartment. A battery that does not fit can damage the stimulator. This device requires 3 AAA batteries, never attempt to use any other battery type.

Preparing the Skin for a Therapy Session:
Proper preparation of the skin is essential to prolong electrode life and reduce the risk of skin irritation.
To prepare your skin at the electrode placement sites:

1. Determine the placement sites for the electrodes. Follow your clinician’s instructions.
   NOTE: Your clinician generally has you place the electrodes above and below (or surrounding) the area of pain or along the “pain path” of your arm or leg.

2. Wash the area with mild soap and water (do not use alcohol). Rinse and dry thoroughly.

3. Trim excess body hair from the area with scissors (do not shave).

4. Optionally, apply skin prep to the area to form a protective barrier on your skin.

5. When removing electrodes, always remove by pulling in the direction of hair growth. Do NOT pull on the wire.

6. It may be helpful to apply skin lotion on the electrode placement area when not wearing electrodes.

Connecting the electrodes to the device:
Hold the insulated portion of the electrode connector and push the plug end of the lead wire into the electrode connector. Repeat for all 4 electrodes. After connecting each electrode, plug the other end of the lead wire into the OTC TENS and EMS unit.
Caution: The device should be OFF before connecting the lead wire to OTC TENS and EMS unit.

Note: Use care when you plug and unplug the wires. Pulling on the lead wire instead of its insulated connector may cause wire breakage.
Caution: Never insert the plug of the lead wire into an AC power supply or other equipment not specified as safe for the lead wires.

ELECTRODES AND ELECTRODE PLACEMENT

General electrode information:
Electrodes should be routinely replaced when they start to lose their adhesive nature. If you are unsure of your electrode adhesive properties, order replacement electrodes. Replacement electrodes should be re-ordered through your local dealer or call Zewa customer service. Follow application procedures outlined on electrode packaging to maintain optimal stimulation and to prevent skin irritation.

Electrode Placement:
The placement of electrodes can be one of the most important parameters in achieving success with therapy. Of utmost importance is the willingness of the clinician to try the various styles of electrode placement to find which method best fits the needs of the individual patient. Every patient responds to electrical stimulation differently and their needs may vary from the conventional setting suggested here. If the initial results are not positive, feel free to experiment. Once an acceptable placement has been achieved, mark down the electrodes sites and the settings, so that the patient can easily continue treatment at home.

Contiguous Electrode Placement:
This is the most common placement technique. It involves pacing the electrodes alongside the area of localized pain sites, in such a way as to direct the flow of current through or around the area of pain. In a single-channel application, this would involve placing each electrode on either side of the pain site if the pain is localized on the limb and deep within the tissue. Electrode placement on the posterior and anterior aspects of the affected limb will allow the current to flow completely through the limb and thus through the endogenous pain site. With a 2 channel application, the clinician may either direct the current flow to cross through the pain site or in what is called the “bracket” method allowing the current flow on either side of the painful area, generally through the nerve branches that feed into the pain site.

Note: Electrodes should be placed between 0.5” – 2” apart from each other.
Caution: The device should be in the OFF position before placing the electrodes on your skin.

USING THE DEVICE

1. Connect the electrodes to the OTC TENS and EMS unit.
2. Place electrodes on your skin.
3. Turn the device ON by pressing the “ON/OFF” button.
4. To switch between TENS and EMS, press the “SET” button. Then press the “UP”(↑) or “DOWN”(↓) button to make changes. Once you have selected TENS/EMS, press “SET” again, and the program starts flashing. The last selected program setting is flashing. To make changes, press the “UP”(↑) or “DOWN”(↓) button. Once you have selected your program, press the “SET” button again.
5. To increase/decrease intensity levels, press the “UP”(↑) / “DOWN”(↓) button.
6. To change the timer, press the “TIMER” button.
7. The device will turn off automatically once the timer reaches “0” (count down minutes are shown on the display). If it was set to C (continuous) the device has to be turned OFF manually.
8. To turn the device OFF manually, press the “ON/OFF” button for 2 seconds.

Note 1:
When the device is in use, push the “SET” button and make changes, the intensity levels will change to “0”. If no changes are made, the intensity levels will not change to 0.
Note 2:
If no button is pushed for 20 seconds while in programming mode, the device will stop flashing. To return into programming mode, follow step 4 above by pressing the “SET” button.
Note 3:
If the device is in programming mode (intensity bars are at “0”), the device will automatically turn OFF after 60 seconds if no button is pushed.

ENDING YOUR TREATMENT SESSION

After the device shuts off, use the following steps as a quick reference for ending your session:

• Disconnect the lead wire(s) from the control unit.
• Remove electrodes from the skin and place them back on the transparent liner. When removing electrodes, always pull in the direction of hair growth. DO NOT REMOVE ELECTRODES WHILE THEY ARE CONNECTED TO THE UNIT TO AVOID GETTING ELECTRIC SHOCK. Do NOT pull on the wires, but peel off on the corner of the electrode.
• Disconnect the lead wire(s) from the electrodes.
• Store the components in the storage bag.

SPECIAL FEATURES

Button Lock Function:
Slide the sliding switch to lock or unlock. The lock feature will lock all buttons so that no accidental changes can be made during treatment.

Automatic Shutoff

• The device turns off automatically when not in use and no button is pressed for 60 seconds.
• The device will turn off automatically when the timer reaches “0” minutes.

Intensity Level Reset

1. For your safety and comfort, the intensity level will reset to 0 each time the device is turned off.
2. For your safety and comfort, the intensity level will reset to 0 when the mode system/program of the device is changed.

Low Battery Indicator
The low battery indicator is displayed whenever the battery is low. The battery needs to be changed.

Programming Recall
The last treatment and timer settings are automatically saved and will appear on the display when the device is turned on for the next treatment.

CARING FOR YOUR DEVICE

The device may be cleaned by gently wiping it with a damp cloth moistened with mild soap and water. Never immerse the device in water or other liquids.
Wipe lead wires with a damp cloth as described above if they become soiled.
To properly store the device for an extended period of time, remove the battery from the device. Put the device and accessories in the storage bag and store them in a cool dry location.

CHANGING THE BATTERY

• When the low battery symbol is displayed, the battery is too weak to power the device and it is time to change it. At this point, the device will shut off until a fresh battery is inserted. If you decide to install a new battery before the device has shut itself off, be sure to turn the power off before you undertake to change the battery.
• To change the battery, open the battery compartment as you did when you first installed it. Pull out the old batteries and insert new ones according to directions.

CAUTIONS:

1. Do not connect the stimulator to any electrical outlet.
2. Remove batteries from the device during storage to prevent battery leakage. Failure to do so may damage the device.
3. Replace the battery if the device was immersed in water or liquid.
4. Never recharge alkaline batteries. An explosion may result.
5. Dispose of all batteries according to current federal, state, and local regulations.

TROUBLESHOOTING

If your device does not function properly:

Problem

| Possible Cause|

Solution

---|---|---

Stimulation is weak

| 1. Low Batteries
2. Poor electrode contact
3. Worn electrodes| 1. Change Batterie
2. Reapply electrodes, secure firmly
3. Replace electrodes
Stimulation stops| 1. Low Batteries
2. Poor electrode contact
3. Damaged or worn lead wires and/or electrodes
4. Therapy time complete| 1. Change Batteries
2. Reapply electrodes, secure firmly
3. Replace lead wires and/or electrodes
4. Restart device
Stimulation weakens with minutes after the start| Normal “adaptation” response| Increase intensity
Unintentional muscle contractions| Intensity too high| Decrease intensity
Stimulation uncomfortable| 1. Intensity too high
2. Improper electrode placement
3. Poor electrode contact| 1. Decrease intensity
2. Reposition electrodes
3. Reapply electrodes, secure firmly
Stimulation ineffective| Improper electrode placement| Reposition electrodes

Note: If there is any other problem, please call Zewa customer service at 1-888-993-3592.

TECHNICAL SPECIFICATIONS

EMS: Program 6
Frequency| TENS: 2~245 Hz (pk)
EMS: 4~99 Hz (pk)
Pulse width Range| TENS: 156~260uS (pk)
EMS: 200~300uS (pk)
Intensity| 0-100 mA
Timer| 5~95 min and Continuous
Power| 4.5V Battery (AAAx3)

※All electrical specification ±20%

Indications for Use:
For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7)
For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities ( arm and/or leg) due to strain from
exercise or normal household and work activities.(Choose TENS Modes P1 through P7)
For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. ( Choose TENS Modes P8)
For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. ( Choose EMS Modes P1 through P6)

Manufactured for Zewa Inc.
12960 Commerce Lakes Drive # 29
Fort Myers, FL 33913
USA
www.zewa.com

Toll-Free Customer Service
1-888-993-3592

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