BodyMed ZZA250 User manual

ENGLISH
READ THIS INSTRUCTION MANUAL CAREFULLY BEFORE USE
Instruction Manual
Transcutaneous Electrical
Nerve Stimulator (TENS)
Reorder Number
ZZA250

General Description................................................................................1
System Components...............................................................................1
Limited Product Warranty......................................................................1
Indications and Contraindications .........................................................2
Warnings and Precautions.....................................................................2
About the Device .....................................................................................4
The Device Controls................................................................................5
Attaching the Lead Wires .......................................................................5
Electrode Selection and Care ................................................................6
Connecting the Device............................................................................6
Battery Information ................................................................................7
Changing the Battery..............................................................................7
Cleaning the Device ................................................................................8
Troubleshooting ......................................................................................8
Technical Specications.........................................................................9
Distributed by BodyMed®
Table of Contents

1
Electrotherapy has proven to be highly valuable as a method of pain therapy. With some
restrictions, physicians or licensed practitioners can prescribe the TENS unit to patients
for at-home use. The unit is a dual-channel electric stimulator for active treatment
application and is equipped with an 8-bit microcomputer that controls the system.
The unit creates electrical impulses intended for targeted pain relief. The intensity,
duration, frequency per second and modulation of these impulses can be adjusted
through the device’s controls.
General Description
The following components or accessories should be included:
• TENS unit • 4 Electrodes (1 pack)
• Carrying case • 9-Volt battery
• 2 lead wires • Operation manual
If you are missing any of these items, please contact BodyMed®at
1-866-528-2152 before using the unit.
System Components
This warranty does not extend to the normal wear of the product and is void if the
product housing has been removed or if the product fails to function properly as a
result of an accident, misuse, abuse, neglect, mishandling, misapplication, defective
batteries, faulty installation, set-up, adjustments, improper maintenance, alteration,
maladjustment of controls, modication, power surges, commercial use of product, use
of product which differs from the suggested use set forth in the product instructions,
service by anyone other than an authorized service center or acts beyond the control of
the manufacturer.
Limited Product Warranty

2
Read the operation manual before using the device. Federal Law restricts this device to
sale by, or on the order of, a physician or licensed practitioner. Follow your physician’s
or licensed practitioner’s precise instructions and let him or her show you where to
apply the electrodes. The correct application of the electrodes is an important factor for
successful therapy. Carefully record the settings your physician or licensed practitioner
recommends for future use.
INDICATIONS FOR USE
This is a prescription device and should only be used for symptomatic relief of chronic
intractable pain as prescribed by a physician or licensed practitioner.
CONTRAINDICATIONS
• Any electrode placement that applies current to the carotid sinus (neck) region.
• The use of TENS whenever pain syndromes are undiagnosed, until cause
is determined.
• Patients with implanted electronic devices (for example, a pacemaker) or metallic
implants should not use this device.
• Any electrode placement that causes current to ow through the head.
WARNINGS
• The device must be kept out of reach of children.
• The safety of the device for use during pregnancy or delivery has not been established.
• Do not place electrodes on front of the throat. This may result in spasms of the
laryngeal and pharyngeal muscles.
• Do not place the electrodes over the carotid nerve (the front and sides of the neck).
Indications and Contraindications
Warnings and Precautions

3
Warnings and Precautions (continued)
• The device is not effective for headaches.
• Caution should be used when applying the device to patients suspected of having
heart disease. Further clinical data is needed to show if there are adverse side
effects on those with heart disease.
• The device may interfere with electronic monitoring equipment (such as ECG
monitors and ECG alarms).
• Electrodes should not be placed over the eyes, in the mouth, or internally.
• This device has no curative value. The TENS unit provides a symptomatic treatment that
suppresses the sensation of pain which would otherwise serve as a protective mechanism.
• TENS devices should be used only under the continued supervision of a physician or
licensed practitioner.
• Do not use on broken skin.
• Treatment effectiveness is highly dependent upon instruction from a person qualied
in pain management using TENS.
• If the device treatment becomes ineffective or unpleasant, stimulation should be
discontinued until re-evaluation by a physician or licensed practitioner.
• Always turn the device off before applying or removing electrodes.
• The device does not have AAP/APG protection. An explosion hazard is possible if
used in the presence of explosives, ammable materials or ammable anesthetics.
Adverse Reactions
Skin irritation and electrode burns are potential adverse reactions. Stimulation should
be stopped and electrodes removed until the cause of the irritation or burns can be
determined. Isolated cases of skin irritation may occur at the site of electrode placement
following long-term application. Always properly clean skin before use. If skin irritation
occurs, discontinue use. Do not resume use of the BodyMed®TENS unit until you have
seen your physician or licensed practitioner.

4
BODYMED SELLS THIS PRODUCT AS-IS AND MAKES NO WARRANTY, EXPRESS
OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ALL SUCH
WARRANTIES BEING HEREBY EXPRESSLY EXCLUDED.
The device offers two controllable output channels. This device creates electrical
impulses whose amplitude, duration and modulation can be altered with the device
controls. The device controls are easy to use, and the slide cover protects accidental
changes in settings.
About the Device
Warnings and Precautions (continued)

5
The Device Controls
Attaching the Lead Wires
SLIDE COVER
A cover conceals the controls for Mode, Time, Width, and Rate. Press the front of the
cover and pull down in order to open the cover.
AMPLITUDE CONTROLS
The Amplitude Control knobs are located on the top of the unit. The Amplitude Control
knobs function as ON/OFF controls and adjust the intensity of the stimulation.
MODE
The Mode switch is used to select and set the type of treatment utilized. The three modes
available are: Burst (B); Continuous (C); and Modulation (M).
TIME
Treatment time can be set with the Time switch. There are two programs of xed
duration for 30- and 60-minutes and one program of continuous output. Press the Time
switch until the desired position is engaged.
WIDTH
The Width dial regulates the width of the pulse for both channels.
RATE
The Rate dial regulates the number of pulses per second for both channels.
Insert the lead wires into the output receptacle located on top of the unit by holding the
insulated portion of the connector and pushing the plug end of the wire into one of the jacks.
After connecting the wires to the unit, attach each wire to an electrode. Lead wires provided
with the device are compliant with mandatory compliance standards as set forth by the FDA.
Note: Use caution when you plug and unplug the wires. Pulling on the lead wire instead of
the insulated connector may cause wire breakage.
Caution: Never insert the plug of the lead wire into an AC power supply socket.

6
Your physician or licensed practitioner should decide which type of electrode is best
for your condition. Follow application procedures outlined in electrode packaging to
maintain stimulation and prevent skin irritation. The packaging will provide instructions
for care, maintenance and proper storage of the electrodes.
Be sure to use the electrodes provided by BodyMed®and/or similar FDA legally
marketed electrodes that are the same size, or larger than, the electrodes that are
provided with this BodyMed®TENS unit.
Electrode Selection and Care
Connecting the Device
IMPORTANT: Be sure both Amplitude Control knobs for Channel 1 and 2 are turned to the
OFF position before connecting the device.
1. Prepare the Skin: Always clean the electrode site with mild soap and water, rinse
well and blot dry thoroughly. Any excess hair should be clipped (not shaved) to
ensure good electrode contact with the skin. You may choose to use a skin treatment
or preparation that is recommended by your physician or licensed practitioner.
This will reduce the chance of skin irritation and extend the life of the electrodes.
2. Connect the lead wires to the electrodes before applying the electrodes to the skin.
3. Place the electrodes on the skin as recommended by your physician or licensed
practitioner. Avoid excessive stretching of the skin when applying electrodes. This is
best accomplished by applying the electrode and smoothly pressing it in place from
the center outward.
4. Insert lead wire connector to device: Plug end of lead wire into the channel output
receptacle to be used, pushing plug in as far as it will go.
5. Select treatment settings: Check that the unit is set to the proper settings as
recommended by your physician or licensed practitioner.

7
Connecting the Device (continued)
Battery Information
Changing the Battery
6. Adjust the Amplitude Control knobs: Locate the Amplitude Control knobs at the top
of the unit. Slowly turn the Amplitude Control knob for Channel 1 clockwise until you
reach the intensity recommended by your physician or licensed practitioner.
Always start with the lowest intensity and increase slowly. Repeat the same process
for Channel 2, if appropriate.
If the stimulation levels are uncomfortable or become uncomfortable, reduce the
stimulation amplitude to a comfortable level. If problems persist, stop treatment and
contact your physician or licensed practitioner.
A 9-volt disposable battery is provided with the unit. When the indicator light is dimming,
the battery has become too weak to power the unit and will need to be changed. At this
point, the unit will shut off until a new battery is inserted.
When the indicator light is dimming, the battery should be replaced with a fresh 9-volt battery.
1. Remove the slide cover by pressing the top and sliding down until it is completely
removed from the unit. This will reveal the battery compartment.
2. Remove the old battery from the device.
3. Place a new battery in the compartment. Note the proper polarity alignment
indicated on the battery and the compartment.
4. Make sure to safely dispose of the old battery.

8
The device may be cleaned by gently wiping with a damp cloth pre-moistened with mild
soap and water. Never immerse the device in water or other liquids.
Wipe lead wires with a damp cloth if they become soiled.
To properly store the device for an extended period of time, remove the battery from the unit.
Put the unit and accessories in the carrying case and store in a cool, dry location.
Cleaning the Device
Troubleshooting
If the device does not function properly:
1. Make sure the battery is properly installed or replace the battery. Be sure to observe
proper polarity markings when replacing the battery. If the indicator light is not on
when the unit is turned on, replace the battery and recheck.
2. If the intensity has been adjusted and there is no stimulation, check that the lead
wires are properly connected and the electrodes are in place. If the unit appears to
be functioning and no stimulation occurs, the lead wires or electrodes may need to
be replaced.
3. If the battery appears to be charged and the unit is not functioning, turn both
Amplitude Control knobs to the OFF position (counterclockwise) for about 7 seconds.
Next, gradually turn the Amplitude Control knobs clockwise until stimulation is felt.
If device is still not working, turn the unit off and contact BodyMed®.
If any other problems occur, please consult or return the device to BodyMed®.
Do not repair a defective device.

9
Channel:
Pulse Intensity:
Pulse Rate:
Pulse Width:
Timer:
Dual, isolated between channels.
Adjustable 0-80 mA peak into 500 Ωload
each channel, constant current.
2-120 Hz (adjustable).
40μs-260μs (adjustable).
30-, 60-minute and continuous mode.
Technical Specications
Function Modes:
B: Cycle Bursts, 2 bursts/sec., 9 Pulses/burst, and 100 Hz, width is adjustable.
C: Continuous mode. Pulse rate, pulse width and intensity are adjustable.
M: Modulated Width. Pulse width is automatically varied in a six-second interval.
The modulation range of pulse width is from setting value to 35% less than the
control setting value, then returns to the setting value. Rate, width and intensity are
fully adjustable.
Wave form: Asymmetrical bi-phasic square pulse.
Voltage: 0-110 Volt (open circuit).
Max Charge Per Pulse: 21 micro-coulombs.
Power Source: 9-volt battery.
Dimensions: 95 mm(H) x 61.5 mm(W) x 26 m(T).
Weight: Approx. 120 grams (battery included).
All electrical specications are +/- 10% except the amplitude is +/- 20% (500 Ωload).

Distributed by BodyMed®
Hudson, Ohio 44236 1-866-528-2152
Made in Taiwan
Reorder Number
ZZA250