BodyMed ZZAIF400 User manual

ENGLISH
READ THIS INSTRUCTION MANUAL CAREFULLY BEFORE USE
Instruction Manual
Interferential Current Stimulator
Reorder Number
ZZAIF400


Distributed by BodyMed®
Table of Contents
General Description................................................................................3
System Components...............................................................................3
Limited Product Warranty......................................................................3
Indications and Contraindications .........................................................4
Warnings/Precautions ...........................................................................5
About the Device .....................................................................................6
Device Controls.......................................................................................6
Attaching the Lead Wires .......................................................................7
Electrode Selection and Care ................................................................7
Connecting the Device............................................................................8
Cleaning the Device ................................................................................8
Adaptor and Battery Information...........................................................9
Changing the Battery..............................................................................9
Troubleshooting ......................................................................................9
Technical Specications.......................................................................10

3
Electrical myostimulation has proven to be highly valuable as a method of pain therapy.
Interferential Stimulators help relieve some types of chronic and acute pain. The unit
is a dual-channel electric stimulator for active treatment application, which is equipped
with a Liquid Crystal Display indicating operation modes and output, as well as an 8-bit
microcomputer for controlling the system. The unit creates electrical impulses. The
intensity, duration, frequency per micro-second and modulation of these impulses can
be adjusted through the device controls. The IF stimulator uses four (4) electrodes,
which allows better focus and deeper tissue stimulation when compared to other types
of electrical stimulation.
General Description
Your BodyMed®ZZAIF400 unit is warranted to be free from defects in materials and
workmanship occurring within one year from date of purchase, when used in strict
accordance with the instructions provided with the BodyMed®ZZAIF400 unit. The
sole remedy for a breach of this warranty is replacement of the defective materials or
components. This warranty extends only to the original purchaser.
The purchase receipt or other proof of date of original purchase is required before full
replacement will be provided.
Please contact BodyMed®at 1-866-528-2152.
Limited Product Warranty
System Components
Your device may include the following components or accessories:
If you are missing any of these items, please contact BodyMed®at 1-866-528-2152
before using.
• Unit
• 9-volt battery
• Carrying case
• 9-volt AC adaptor
• 2 lead wires
• Operation manual
• 4 Electrodes (1 pack)

4
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/her show you where to apply
the electrodes. For successful therapy, the correct application of the electrodes is an
important factor. Carefully write down the settings your physician or licensed practitioner
recommends.
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
• Do not place electrodes in a way that applies
current to the carotid sinus (neck) region
• Do not use unit if you have pain symptoms that are
undiagnosed, until cause is determined.
• Do not use unit if you have any implanted electronic
devices (for example, a pacemaker) or metallic implants
• Do not place electrodes in a way that causes current to
ow trans-cerebrally (through the head)
Indications and Contraindications
Limited Product Warranty (continued)
BodyMed®MAKES NO OTHER 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 warranty described above 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.
BodyMed®SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL
OR SPECIAL DAMAGES, WHETHER ARISING UNDER CONTRACT, TORT, STRICT LIABILITY,
STATUTE OR OTHER FORM OF ACTION, OR ANY DAMAGES IN EXCESS OF THE COST OF
THE REPLACEMENT OF THE PRODUCT.

Warnings and Precautions
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).
• 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.
• These devices have no curative value. The Interferential is a symptomatic treatment
that suppresses the sensation of pain which would otherwise serve as a protective
mechanism.
• Interferential devices should be used only under the continued supervision of a
physician or licensed practitioner.
• Do not use on broken skin.
• Effectiveness is highly dependent upon patient selection by a person qualied in pain
management.
• 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 ZZAIF400 unit until you
have seen your physician or licensed practitioner.

6
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The device offers two controllable output channels. It creates electrical impulses whose
amplitude, duration, and modulation can be altered with the device controls. The device
controls are easy to use, and the Cap and Slide Cover prevents accidental changes in
settings.
About the Device
Device Controls
Slide Cover
A cover conceals the key controls for Mode, Time, Width and Rate. Press the front of the
cover and pull down to open the cover.
Amplitude Controls
The Amplitude Control Knobs are located on the top of the unit, under the cap. The
Amplitude Control Knobs function as ON/OFF controls and adjust the intensity of the
stimulation.
Mode
The Mode key is used to select/set the type of treatment utilized. There are nine modes:
one Constant, three Auto Sweep, and ve Frequency Shift. With each press of the key, you
switch to the next mode. The selected mode will be shown on the LCD and will blink.

7
Rate
The Rate key regulates the number of pulses per second for both channels. This key
selects the pulse frequency of the therapy current. By pressing the , you can increase
the frequency in 4 bps/step. By pressing the , you can decrease the frequency in 4 bps/
step.
Time
Treatment time can be set with Time key. There are two programs of xed duration for 15
and 30 minutes. Press the Time key until the desired program is engaged. To reset timer,
turn both channels off. When you are ready to begin another treatment cycle, turn the unit
on as normal. The timer will be reset to its current setting.
Device Controls (continued)
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
ZZAIF400 EMS unit.
Electrode Selection and Care
Attaching the Lead Wires
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.

8
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: 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.
6. Locate the Amplitude Control Knob 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.
The device may be cleaned by wiping gently 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 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

9
Adaptor and Battery Information
9-volt AC Adaptor
Because the current consumption is high for the IF unit, it is recommended to use the
9-volt AC adaptor. Place the AC plug into the AC jack of the unit, and plug the adaptor into a
110-volt wall outlet. Please be sure to use the correct polarity for the AC plug.
Battery
A 9-volt disposable battery is also provided with your unit. When the low-battery indicator
appears, 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.
Note: Due to the high output of this device, the 9-volt battery will run out of power
quickly. The 9-volt AC adaptor is the recommended power source.
Changing the Battery
When the low-battery indicator appears on the LCD panel, the battery should be replaced
with a new 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.
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 low-battery
indicator appears 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 5
seconds. Next, gradually turn the Amplitude Control Knobs clockwise until
stimulation is felt. If device is still is not working, turn the unit off and contact
BodyMed.

10
Troubleshooting
4. If the “hr” symbol is displayed when the unit is turned on, immediately turn the unit
off. You may turn the unit back on once more and use normally if the “hr” symbol is
not displayed. Do not hold down any keys when turning on the unit. Do not use the
unit if the “hr” symbol is displayed. Contact your physician or licensed practitioner
for more information.
5. If the “lock” symbol is displayed when the unit is turned on, this indicates that the
unit has been locked by your physician or licensed practitioner. It can still be used,
but treatment parameters cannot be changed. Please contact your physician or
licensed practitioner to unlock the unit or change treatment parameters.
If any other problems occur, please consult or return the device to BodyMed. Do not try
to repair a defective device.
Technical Specications
Channel: Dual, isolated between channels
Pulse Intensity: Adjustable 0-80mA peak into 500 Ωload each channel, constant
current
Carrier Frequency 4000 Hz xed (CH1)
Modulating Frequency 4004-4160 Hz Adjustable (CH2)
IF Frequency Mode Constant Mode: 4-160 bps, Adjustable
Auto Sweep: 80 -145 bps, 4 - 45 bps, 4 - Set bps Frequency Shift: 1/1
abruptly shift, 6/6 abruptly shift, 6/6 ramped, 10/10 abruptly shift,
10/10 ramped
Sweep Time 15 seconds
Frequency Shift Percent Frequency shifts from 30% below set frequency to 60% above and
returns to 30% below set
Output Conguration: Quad polar (4 electrodes)
Wave Form: Symmetrical balanced Sine wave
Interference Pulse Freq.: 4 - 160 bps, adjustable 4 bps/step
Pulse Duration: 125 μs maximum
Patient Compliance Meter: Shows the treatment times in hours
Patient Lock System: Prevents the user from changing any xed parameters set by the
physician or licensed practitioner
Timer: 15-, 30-minute
LCD: Shows modes, bps rate, abrupt/ramp, timer and channels
Max. Charge per Pulse: 15 micro-coulombs maximum
Power Source: 9-volt AC adaptor, 500 mA or 9-volt battery (not recommended)
Dimension: 108 x 61.5 x 25 mm
Weight: 100 grams (without battery)
Tolerance: +/-10%

11
Function Modes
Output Parameters: There are nine modes: ve modes with Frequency Shift, three modes
with Auto Sweep, and one mode that is fully adjustable.
Constant Mode: Maintains set pulse frequency. (SET: bps can be adjusted)
Auto Sweep: Modulates frequency between the range that is selected. For example, select
80 - 145 bps Auto Sweep model. The modulation range of pulse frequency is from 80 to 145
bps. The Sweep Time is 15 seconds and then repeats.
There are three modes of Auto Sweep:
1. 80 – 145 bps
2. 4 – 45 bps
3. 4 – SET bps
Frequency Shift: There are ve modes:
1. 1/1 abruptly shift: The pulse frequency varies from –30% to +60% of the set pulse
frequency. One second at the lower frequency, and one second at the higher
frequency. The transition is abrupt (square wave function).
2. 6/6 abruptly shift: The pulse frequency varies from –30% to +60% of the set pulse
frequency. Six seconds at the lower frequency, and six seconds at the higher
frequency. The transition is abrupt (square wave function).
3. 6/6 ramped shift: The pulse frequency sweeps from –30% to +60% of the set pulse
frequency. Six seconds from the lower frequency modulate to the high frequency,
and six seconds from the higher frequency modulate to the lower frequency. The
transition is ramping (triangular wave function).
4. 10/10 abruptly shift: The pulse frequency varies from –30% to +60% of the set
pulse frequency. Ten seconds at the lower frequency, and ten seconds at the higher
frequency. The transition is abrupt (square wave function).
5. 10/10 ramped shift: The pulse frequency sweeps from –30% to +60% of the pulse
frequency. Ten seconds from the lower frequency modulate to the high frequency,
and ten seconds from the higher frequency modulate to the lower frequency. The
transition is ramping (triangular wave function).
Technical Specications (continued)

Distributed by BodyMed®
Hudson, Ohio 44236 1-866-528-2152
Made in Taiwan
Reorder Number
ZZAIF400