Grafco GF-TX5 User manual

Transcutaneous Electrical
Nerve Stimulation
(TENS), Digital
Model GF-TX5
Operation Manual
GF-TX5-INS-LAB-RevA09
Read this manual before operating your GF-TX5.
Save this manual for future use.
The most current version of this manual can be found online at
www.grahamfield.com

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Contents
GENERAL DESCRIPTION ................................................................................................... 3
WHAT IS TENS? ............................................................................................................... 3
INDICATIONS AND CONTRAINDICATIONS........................................................................... 3
SAFETY ........................................................................................................................... 4
ABOUT THE DEVICE.......................................................................................................... 6
EXPLANATION OF KEY / KNOB CONTROL FUNCTIONS ........................................................ 7
ATTACHING THE LEAD WIRES ........................................................................................... 8
ELECTRODE SELECTION AND CARE................................................................................... 8
TIPS FOR SKIN CARE ....................................................................................................... 8
CONNECTING THE DEVICE ................................................................................................ 9
BATTERY INFORMATION................................................................................................. 10
CARING FOR YOUR DEVICE............................................................................................. 11
TROUBLESHOOTING ....................................................................................................... 11
TECHNICAL SPECIFICATIONS.......................................................................................... 12
LIMITED WARRANTY ...................................................................................................... 15
GF Health Products, Inc. is not responsible for typographical errors. Packag-
ing, warranties, products and specifications are subject to change without
notice.
Graham-Field and Grafco are registered trademarks of GF Health Products,
Inc.

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GENERAL DESCRIPTION
TENS, Transcutaneous Electrical Nerve Stimulation, is a method of relieving
symptomatic chronic intractable pain.
This unit is a dual-channel digital stimulator for active treatment application,
which has a Liquid Crystal Display indicating operation modes and output as
well as an 8-bit microcomputer for controlling the system.
The electronics of the unit create electric impulses; the intensity, duration,
frequency per second and modulation of these impulses can be adjusted.
WHAT IS TENS?
TENS is a treatment whereby electrical impulses are applied to nerves
through electrode pads placed on the skin. TENS is non-invasive and does not
use pharmaceuticals.
TENS uses a two-pronged approach to pain relief. First, sensory nerves are
targeted, stimulating them to block pain signals and prevent their transmis-
sion to the brain. Second, TENS promotes the production of endorphins —
neurochemicals occurring naturally in the brain — which have analgesic
properties.
INDICATIONS AND CONTRAINDICATIONS
Read the operation manual before using this TENS device.
Federal law (USA) restricts this device to sale by or on the order of a physi-
cian.
Indications
TENS is indicated to be used under a physician’s prescription for the symp-
tomatic relief of chronic intractable pain.
Contraindications
• Anyelectrodeplacementwhichappliescurrenttothecarotid(neck)
region.
• Patientswithimplantedelectronicdevices(forexample,apacemaker)
or metallic implants should not undergo TENS treatment without first
consulting a physician.

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• Anyelectrodeplacementwhichcausescurrenttoflowtranscerebrally
(through the head).
• Theuseof unitwheneverpainsymptomsareundiagnosedandtheetiol-
ogy is unknown.
SAFETY
Always follow basic safety precautions, including the following:
WARNING: Indicates a potential hazard situation or unsafe practice that, if not
avoided, could result in death or serious personal injury.
sCaution: Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury or product/property damage.
Warnings
WARNING: Explosion hazard
Explosion hazard is possible if used in the presence of explosives, flammable
materials or flammable anesthetics.
WARNING: Heart disease
Caution should be used when applying the device to patients suspected of hav-
ing heart disease. Further clinical data is needed to show if there are adverse
side effects on individuals with heart disease.
WARNING: Keep this device out of the reach of children.
WARNING: The safety of the device during pregnancy or delivery has not been
established.
WARNING: Do not place electrodes on front of the throat. This may result in
spasms of the laryngeal and pharyngeal muscles.
WARNING: Do not place the electrodes over the carotid nerve.
WARNING: The device is not effective for pain of central origin (headaches).
WARNING: Avoid adjusting controls while operating machinery or vehicles.

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WARNING: The device may interfere with electronic monitoring equipment
(such as ECG monitors and ECG alarms).
WARNING: Do not change any mode during treatment.
WARNING: Some patients may experience skin irritation or hypersensitivity
due to the electrical stimulation or electrical conductive medium. Using an
alternate conductive medium or alternate electrode placement can usually
reduce the irritation. Consult your physician/clinician before using an alterna-
tive conductive medium or electrode placement.
WARNING: Electrodes should not be placed over the eyes, in the mouth, or
internally.
WARNING: The device has no curative value.
WARNING: TENS devices should be used only under the continued supervision
of a physician/clinician.
WARNING: TENS is a symptomatic treatment and as such suppresses the sen-
sation of pain which would otherwise serve as a protective mechanism.
Precautions/Adverse Reactions
sCaution: Isolated cases of skin irritation may occur at the site of electrode placement
following long-term application.
sCaution: If skin irritation occurs TENS treatment should be stopped and electrodes
removed until the cause of the irritation can be determined.
sCaution: Effectiveness is highly dependent upon patient selection by a person qualified
in the management of pain patients.
sCaution: If the device treatment becomes ineffective or unpleasant, stimulation should
be discontinued until reevaluation by a physician/clinician.
sCaution: Always turn the device OFF before applying or removing electrodes.

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ABOUT THE DEVICE
This device is a battery-operated device that includes two controllable output
channels. This device creates electrical impulses in which amplitude, dura-
tion, and modulation can be altered. The device controls are easy to use and
the slide cover protects accidental changes in settings.
System Components
Your device will include the following components or accessories:
 • TENSUnit
• Carryingcase
• Leadwires
• 9-Voltbattery
• OperationManual
• Electrodes
Device Controls
Slide Cover
Thiscoverlocatedonthefrontof theunitconcealsthecontrolsforDOWN,
MODE,SET,andUP.Pressthetopportionof thecoverandpulldowninorder
to open the cover.

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EXPLANATION OF KEY / KNOB CONTROL FUNCTIONS
DOWN key This key decreases the setting
when in pulse width or pulse
rate. *
This key regulates the number of pulse width or
rate of the individual current pulses.
*Decrease by pressing the DOWN key: The width can be adjusted in 1-20Hz by
1Hz/step, 20Hz-150H by 5Hz/step. The rate can be adjusted in 10us/step.
MODE key Timer/Stimulation modes/
Alternate mode/Pulse
rate (Hz)/Pulse width (uS)
selection
This key changes the different treatment
parameters. Each time the mode key is
pressed, the next treatment parameter will
display. The selected treatment parameter in
the current mode will ash.
SET key This key switches between
the different settings in the
Timer, stimulation mode, and
alternate mode treatment
parameters.
Each time the SET key is pressed, the
parameter will change to the next setting.
The selected mode setting will ash. After the
desired parameter is ashing, press MODE to
switch to the next treatment parameter. The
parameter just set will be displayed and will no
longer ash.
UP key This key increases the setting
when in pulse width or pulse
rate. *
This key regulates the number of pulse width or
rate of the individual current pulses.
*Increase by pressing the UP key: The width can be adjusted in 1-20Hz by 1Hz/
step, 20Hz-150H by 5Hz/step. The rate can be adjusted in 10us/step.
Ch1 /Ch2
Knobs
Intensity control knobs Control the strength of the stimulation and
also function as ON/OFF controls.

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ATTACHING THE LEAD WIRES
Ensure the device is OFF before connecting the lead wires.
The lead wires provided with the device insert into the jack sockets located
the top of the unit. If only one lead will be used, plug it into the channel 1
jack. After connecting the wires to the unit, attach each wire to an electrode.
Lead wires provided with the device are compliant with mandatory compli-
ance standards set forth by the FDA.
Note: Use care when you plug and unplug the wires. Pulling on the lead wire
instead of its insulated connector may cause wire breakage.
ELECTRODE SELECTION AND CARE
Using Electrodes
Use the electrodes as prescribed. Follow application procedures outlined in
electrode packing to maintain stimulation and prevent skin irritation.
TIPS FOR SKIN CARE
Good skin preparation is important for effective comfortable use of your
TENS device.
• Alwayscleantheelectrodesitewithmildsoapandwatersolution,rinse
well, and dry thoroughly prior to any electrode application.
• Anyexcesshairshouldbeclipped,notshaved,toensuregoodelectrode
contact with the skin.
• If askintreatmentorpreparationisrecommendedbyyourphysician/
clinician, apply the skin treatment as recommended, let dry, and apply
electrodes as directed. Following these recommendations will both re-
ducethechanceof skinirritationandextendthelifeof yourelectrodes.
• Avoidexcessivestretchingof theskinwhenapplyingelectrodes.Proper
application is best accomplished by applying the electrode, then smooth-
ly pressing it in place from the center outward.
• Whenremovingelectrodes,alwaysremovebypullinginthedirectionof 
hair growth.

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It may be helpful to rub skin lotion on electrode placement area when not
wearing electrodes.
CONNECTING THE DEVICE
Insert battery
TurnthedevicetotheOFFpositionbeforeinsertingorremovingthebattery.
Wheninsertingthebattery,ensurethebatterypolarity(+and-)markings
match the markings on the device.
Prepare the Skin
Prepare the skin as previously described and according to the instructions
provided with your electrodes. Before attaching the electrodes, identify the
areathatyourphysician/clinicianhasrecommendedforelectrodeplacement.
1. ConnecttheLeadWirestotheelectrodes:Connecttheleadwirestothe
electrodes before applying the electrodes to the skin.
Note: Ensure both intensity controls for Channel 1 and 2 are turned to the “OFF”
Position (counterclockwise) before applying the electrodes.
2. Place Electrodes on the Skin: Place the electrodes on the skin as recom-
mendedbyyourphysician/clinician.
3. InsertLeadWireConnectorintotheDevice:Plugendof leadwireintothe
channel output port (jack) to be used; push the plug in as far as it will go.
4. Select Treatment Settings: Ensure your unit is still set to the proper set-
tingsrecommendedbyyourphysician/clinician.
5. Adjusting Channel Intensity Control: Locate the intensity control knob
(Channel 1 or 2) at the top of the unit. Slowly turn the intensity control
knob clockwise until the stimulation is at the level recommended by your
physician/clinician.(If youdon’tfeelanything,turntheknobOFFthen
ONagainandcarefullyturnthecontrolknobuntilyoufeelatinglingor
slight twitch under or around the electrodes.) Always start with the low-
est setting and increase the intensity slowly.

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If the stimulation levels are uncomfortable or become uncomfortable,
reduce the stimulation amplitude to a comfortable level; or cease stimu-
lation and contact your physician.
6. Setting Patient Compliance Counter:
a) Toturncounteron:WhiletheunitisON,holddowntheUPbutton
andpresstheMODEbuttonatthesametime.
b) ToResetCounter:WhiletheunitisON,pressUPbuttonandpress
theMODEbuttonatthesametime(thiswilltakeyouintothecompli-
ancecounter),thenpushtheDOWNbuttonandpressMODEbutton
at the same time.
c) PresstheUPandMODEbuttonsatthesametimetoreturntothe
treatment status.
If the stimulation levels are uncomfortable or become uncomfortable, reduce
the stimulation intensity to a comfortable level; or if problems persist, cease
stimulationandcontactyourphysician/clinician.
BATTERY INFORMATION
A9-voltdisposablealkalineand/ornickel-cadmiumbatteryisprovidedwith
yourunit.WhentheLCD(LiquidCrystalDisplay)lowbatterymarkillumi-
nates,thebatteryhasbecometooweaktopowertheunit,andtheexisting
battery should be replaced with a new battery. At this point, the unit will turn
OFFuntilanewbatteryisinserted.
Changing the Battery
WhentheLCDlowbatterymarkilluminates,andtheunitdoesnotremainillu-
minated once turned on, the battery should be replaced.
1. TurnunitOFF
2. Remove the front panel cover by pressing on the top of the panel and
pressing down in order to slide the panel down. Continue sliding the
panel downwards until the panel is completely removed from the unit.
This will reveal the battery compartment.
3. Remove the discharged battery from the device.

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4. Place new battery in the compartment. Note: Be sure the proper polarity
(+and-)markingsmatchthemarkingsinthedevice.
CARING FOR YOUR DEVICE
Your device may be cleaned by wiping gently with a damp cloth moistened
with mild soap and water. Do not immerse the device in water or other liq-
uids.
Wipeleadwireswithdampclothmoistenedwithsoapandwater.Donotim-
merse the lead wires.
Toproperlystorethedeviceforanextendedperiodof time,removethe
battery from the unit. Place the unit and accessories in the carrying case
provided and store in a cool, dry location.
TROUBLESHOOTING
If the device does not function properly:
1. Ensure the battery is properly installed or replace the battery. Be sure to
observe proper polarity markings when replacing the battery. If the LCD
low battery mark illuminates when the unit is turned on, replace the bat-
tery and check again.
2. If the intensity has been adjusted and no stimulation is felt, check to
ensure the lead wires are properly connected and the electrodes are
properly applied to the skin. If the unit appears to be functioning and no
stimulation is felt, 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intensitycontrolknobstotheOFFposition(counterclockwise).Then
gradually turn the intensity Control Knob (clockwise) until stimulation
is felt. If device still is not working, turn the unit off and contact your
authorized GF Health Products, Inc distributor.
If there is any other problem, please contact an authorized GF Health Prod-
uct, Inc. distributor. Do not try to repair a defective device.

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TECHNICAL SPECIFICATIONS
Channel Dual, isolated between channels
Pulse Amplitude Adjustable 0 – 80 mA peak into 500* load each channel, constant
current
Pulse Rate 1Hz-150Hz (adjustable)
Pulse Width 30-300uS (adjustable)
Timer 10, 20, 30, 40, 50, 60 minutes and continuous
Patient Compliance
counter
To show the usage time by user, counted per each 30 minutes treatment
time
Patient Lock System To prevent changes in any set parameter by physician/clinician. To
unlock or lock the unit, press the UP and DOWN button simultaneously
for 2-3 seconds
Wave Form Mono Positive-Phasic Square pulse, Negative-Phasic Square Pulse,
Asymmetrical Bi-Phasic Square Pulse
LCD Display Timer, Function Mode, Alternate mode, Pulse Rate, Pulse Width,
Battery Low and Patient Compliance Meter, Lock symbols
Function Mode M Mode Modulated width: Pulse width is automatically varied in an
interval of 6 seconds. The modulation range of pulse width
is from setting value to 60% less than the control setting
value, then returns to the setting value. Pulse Rate and
Pulse Width are adjustable.
MM Mode Modulated Rate and Width: This mode consists of
alternating modulated width and modulated rate.
One parameter is always decreasing while the other is
increasing and vice-versa. The modulation range is 50%
decreasing.

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Function Mode,
Continued
MR Mode Modulated Rate: The pulse rate is automatically varied in
an interval of 0.5 seconds. The modulation range of pulse
rate is from setting value to 50% less than the control
setting value, then returns to the setting value. Pulse rate is
adjustable but pulse width is xed.
B (Burst
Mode)
Bursts consist of Pulse Width (adjustable),
frequency=100Hz. Bursts occur twice every second.
©
(Constant
Mode)
Pulse rate and Pulse width are adjustable.
SD Mode Strength Duration and Rate/Width modulation adjustable.
SD Mode consists of alternating modulated Pulse Rate and
Pulse Width. One parameter is increasing while the other
parameter is decreasing and vice-versa. The variety value is
50%; full cycle time is 22 seconds.
Alternate
Mode
Stimulation output will begin from Channel 2, last for
12 seconds, then switch to Channel 1 for 12 seconds.
During this mode, the stimulation will continue to alternate
between the two channels.
Voltage 0 – 100 volt (open circuit)
Power Source 9-volt battery (alkaline or nickel-cadmium rechargeable)
Battery Life Approximately 70 hours at nominal settings.

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LCD (Liquid Crystal Display)
The LCD displays timer (10, 20, 30, 40, 50, 60 minutes and © continuous),
functionmodes(B,C,M,MM,MR,SD),alternatemode,pulserate,pulse
width, battery low, and patient compliance meter.
1. TochecktheLCDfunction,turndeviceONandalltheparameterswillbe
displayed for 1-2 seconds.
2. After 1-2 seconds, the LCD will go to previous operation parameters.
CHANGING THE LCD PARAMETERS
• TosetthetreatmentparametersontheTENSdevice,theunitmustbe
intheUNLOCKposition.If thedeviceisintheLOCKpositionit,canbe
unlockedbypressingtheUPandDOWNbuttonssimultaneouslyfor2-3
seconds.
• Toswitchbetweenthedifferenttreatmentparameters,pressthemode
button.
• Onceinthedesiredmode,presstheup,down,orsetbuttonuntilthe
desired treatment parameter is obtained.
• Onceallof thedesiredtreatmentsettingsaredisplayed,theunitmay
belockedbypressingtheUPandDOWNbuttonssimultaneouslyfor2-3
seconds while in the time function.

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LIMITED WARRANTY
GF Health Products, Inc. warrants the Transcutaneous Electrical Nerve Stimu-
lation(TENS),ModelGF-TX5,againstmanufacturer’sdefectsforoneyear.
The warranty does not apply to damage resulting from failure to follow the
operating instructions, accidents, abuse, alterations or disassembly by unau-
thorized individuals.
During the warranty period, defective items will be repaired or replaced at GF
HealthProducts,Inc.option.Warrantydoesnotincludeanylaborcharges
incurred in replacement part(s) installation or any associated freight or ship-
ping charges to GF Health Products, Inc.

USA Corporate Headquarters:
GF Health Products, Inc.
2935 Northeast Parkway
Atlanta, Georgia 30360 USA
tel: [phone]
fax: [phone]
www.grahameld.com
GF-TX5-INS-LAB-RevA09
© GF Health Products, Inc., October 2009