Drive Medical AGF-3X User manual

PortWashington,NY11050
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INDEX
Chapter Contents Page
1. Introduction...........................................................................2
2. Cautions...............................................................................3
3. Warnings.............................................................................3
4. General Description.............................................................4
5. Construction........................................................................5
6. Technical Specifications.......................................................6
7. Replaceable Parts 7
8. Accessories ... ...7
9. Graphic Symbols ........ .. .8
10.Parameter Controls ... .8
11.Attachment of Electrodes Lead Wires .. ...10
12.Lead Wire Maintenance .................10
13.Electrode Options ..................10
14.Electrode Placement ...............11
15.Tips For Skin Care ..................11
16.Application of Re-usable Self Adhesive Electrodes ..........12
17.Adjusting the Controls ...............13
18.Battery Information ... ..........16
19.Maintenance, Transportation and Storage of
TENS Device ........................................................ ........17
20.Safety Control .................18
21.Malfunctions ....................18
22.Conformity to Safety Standards.. ...............19
23.Warranty ............................19
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Chapter 2 : CAUTIONS
1. Precautions:
Isolated cases ofskin irritation may occur atthe site of electrode placement
following logn-term application.Effectivenessis highlydependent upon patient
selection by a person qualified in the management of pain patients.
2. Contradictions:
TENS devices can affect the operation of demand type cardiac pacemakers.
TENSisnotrecommendedforpatientswith knownheartdiseasewithout physi-
cal evaluation of risk. Do not use TENS on the carotid sinus(neck) region. Do
no apply TENS for undiagnosedpain syndromes until etiology is established.
Do notstimulate on the site that maycause current to flowtranscerebrally
(throughthehead).
3. AdverseReactions
Possible allergic to gel, skin irritation and electrode burn are potential adverse
reactions.
4. Read operation manual before use of TENS.
5. We emphasize that patient with an implanted electronic device (for example, a
pacemaker)shouldnotundergoTENStreatmentwithoutfirstconsultingadoctor.
Thesame applies to patients with any metallic implants.
6. If TENS therapybecomes ineffective or unpleasant, stimulation should be dis-
continued until its use is reevaluated by the physician or therapist.
7. Avoid adjustingcontrols whileoperating machineryor vehicles.
8. Turn the T.E.N.S. off before applying or removing electrodes.
9. AGF-3XT.E.N.S. devices have no AP/APG protection.
Do not use it in the presence of explosive atmosphere and flammable mixture.
Chapter 3 : WARNINGS
1. Cautionshouldbe usedinapplyingTENStopatients suspectedofhavingheart
disease. Further clinical data is needed to show there are no adverse results.
2. The safety of TENS devices for use during pregnancy or birth has not been
established.Do not use TENS during pregnancy.
3. TENS is not effective for pain of central origin. (This includes headache.)
Chapter 1 : INTRODUCTIONEXPLANATION OF PAIN
Pain is a warning system and the body s method of telling us that something is
wrong. Pain is important; without it abnormal conditions may go undetected,
causing damage orinjury to vital parts of our bodies.
Even though pain is a necessary warning signal of trauma or malfunction in the
body,naturemayhavegonetoo farinitsdesign. Asidefromitsvalueindiagnosis,
long-lasting persistent pain servesno useful purpose. Pain does notbegin until a
coded message travels to the brain where it is decoded, analyzed, and then re-
acted to. The pain message travels from the injured area along thesmall nerves
leading to the spinal cord. Here the message is switched to different nervesthat
travel up the spinal cord to the brain. The pain message is then interpreted, re-
ferred back and the pain is felt.
EXPLANATION OF TENS
Transcutaneous ElectricalNerve Stimulation is a non-invasive, drug-free method
of controlling pain. TENS uses tiny electrical impulses sent through the skin to
nerves to modify your pain perception. TENS does not cure any physiological
problem;itonlyhelpscontrolthepain. TENS doesnotworkforeveryone;however,
in most patients it is effective in reducing or eliminating the pain, allowing for a
return to normal activity.
HOW TENS WORKS
There is nothing “magic”about Transcutaneous Electrical Nerve Stimulation
(TENS). TENS is intended to be used to relieve pain. The TENS unit sends
comfortable impulses through the skin that stimulate the nerve(or nerves) in the
treatment area. In many cases,this stimulation will greatly reduce oreliminatethe
pain sensation the patient feels. Pain relief varies byindividual patient, mode se-
lectedfortherapy,andthetypeofpain. Inmany patients,the reduction orelimina-
tion of pain lasts longer than the actual period of stimulation (sometimes as much
as three to four times longer). In others, pain is only modified while stimulation
actually occurs. You may discuss this with your physician or therapist.
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Chapter 5 : CONSTRUCTION
4. TENS devices should be used only under the continued supervision of a
physician.
5. TENS devices have no curative value.
6. TENS is a symptomatic treatment and as such suppresses the sensation
of pain which would otherwise serve as a protective mechanism.
7. Electronic monitoring equipment (such as ECG monitors and ECG alarms)
may not operate properly when TENS stimulation is in use.
8. There should be a prominently placed statement warning that stimulus
delivered by this device may be sufficient to cause electrocution. Electrical
current of this magnitude must not flow through the throax because it may
cause a cardiac arrhythmia.
9. Do not place electrodes on the front of the throat as spasm of the Laryngeal
and Pharyngeal muscle may occur.
10.Care should be taken so that when operating potentially dangerous ma
chinery the stimulator controls are not changed abruptly.
11. Electrodes should not be placed over the eyes, in the mouth, or internally.
12.Keep this device out of the reach of children.
13.Caution: Federal law restricts this device to sale by or on the order of a
physician
Chapter 4 : GENERAL DESCRIPTION
The AGF-3X TENS is a battery operated pulse generator that sends electrical
impulses electrodes to the body and reach the nerves causing pain. The
device is provided with two controllable output channels, each independent of
each other. An electrode pair can be connected to each output channel.
The electronics of the AGF-3XTENS create electrical impulses whose Intensity,
duration, number per second and modulation may be altered with the controls
or switches. Dial controls are very easy to use and the panel cover connected
with device prevents accidental changes in the setting.
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Chapter 7 : REPLACABLE PARTS
The replaceable parts and accessories of T.E.N.S. devices are as given below
–Except leads, electrodes and battery, battery case cover, please do not try to
replace the other parts of a device.
NO. PARTS
01 ELECTRODES LEADS
02 ELECTRODES
03 9V BATTERYTYPE 6F22
04 BELT CLIP
05 BATTERY CASE COVER
06 LEAD CONNECTOR
07 MAINPCB
08 INTENSITYKNOB
09 B-N-MSWITCH
10 PULSEWIDTH KNOB
11 PULSE RATE KNOB
Chapter 8 : ACCESSORIES
Each set AGF-3X TENS are completed with standard accessories and standard
label as given below
I. Accessories
REF. NO. DESCRIPTION QTY
AGF-101 40 X 40 mm Adhesive Electrodes 4 pieces
AGF-111N Electrodes Leads 2 pieces
9 V Battery 1 piece
InstructionManual 1piece
Carrying Case 1 piece
Chapter 6 : TECHNICAL SPECIFICATIONS
The technical specification details of AGF-3X TENS are as follows.
MECHANISM TECHNICALDESCRIPTION
1. Channel Dual, isolated between channels
2. Pulse Ampulitude Adjustable, 0 - 80 mA peak into 500 ohm load
each channel
3. Pulse Rate Adjustable, from 2 to 150 Hz
4. Pulse Width Adjustable, from 30 to 260 microseconds
5. Modulation Mode Pulse rate is automatically varied in a cyclic
pattern over an interval of nominally 10
seconds.(in max 150Hz) Pulse rate decreasesl
inearly over a period of 4 seconds from the
control setting value to a value which is 40%
less. The lower pulserate will continue for
1second. Then increase linearly over a 4
seconds period to its original value. The
original pulse rate will continue for 1 second.
The cycle is then repeated
6. Burst Mode Bursts occur twice very second.
Pulse width(adjustable), frequency = 100 Hz
7. Wave Form Asymmetrical Bi-Phasic Square Pulse
8. Voltage 0 to 34 V (Load : 500 ohm)
9. Max. Charge per pulse 20 micro-coulombs
10. Burst Mode One 9 Volt Battery.(alkaline, or nickel-cadmium
rechargable)
11. Battery Life Approximately 50 hours at nominal settings.
12. Size 70(H) x 103(W) x 23.5(T) mm
13. Weight 115 grams(battery included)
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directly through the area of pain or localized enervation), a quick pulse rate
(setting greater than 80Hz on the Pulse Rate Control) is desired. The patient
should not perceive individual pulses but rather have the sensation of steady
continuous stimulation.
Despite above recommendations, these individual patients may require slight
variations of the above settings, according to the nature of their condition.
TREATMENT MODE
NormalorConventional TENSoffersthepractitionerscompletecontroloverallthe
various treatment parameters of the instrument.
Burst Mode is analogous to the Low Rate TENS technique except the low fre-
quencyindividualpulsesarereplacedbyindividual“bursts”of7-10individualpulses.
It is thus a combination of Conventional TENS and Low Rate TENS. In Burst
Mode,thetreatmentfrequencyisfixedbytheinstrument andisnotadjustablewith
the FrequencyRate control.
Modulated Mode attempts to prevent nerve accommodation by continuously cy-
cling the treatment intensity. When using Modulated Mode increase the intensity
only when the unit is at the maximum intensity of the modulation cycle. If the
intensityisincreasedduringa lowintensityperiodofthecycle,the patientmayturn
up the control very slowly, so that they may feel the intensity any higher.
TIME DURATION
The onset of pain relief should occur shortly after the intensity setting has been
determined. However, in some cases, pain relief may take as long as 30 minutes
to achieve. TENS units are typically operated for long periods of time, with a mini-
mum of 20 –30 minutes and in some post-operation protocols, as long as 36
hours.
In general, pain relief will diminish within 30 minutes of the cessation of
stimulation.
II.LABEL The label attached to the back of device
contains important message about this
device- model, serial number, supply
voltage, CE number and classification.
Please do not remove.
Chapter 9 : GRAPHIC SYMBOLS
1. Note Operating Instructions
2. Degree of Electrical Protection BF
3. Do not insert the plug into AC power supply socket.
4. Direct Current (DC power source)
Chapter 10 : PARAMETER CONTROLS
PULSE DURATION
Wider pulse duration settings will deliver stronger stimulation for any given inten-
sitysetting. Asmentionedin the Controls section, byusing acombination of inten-
sityandpulseduration,itisfeltthatvariouspulsewidthsare capableofstimulating
different groups of nerve fibres.
The choice of which pulse duration to use is partially dependent upon the Treat-
ment Mode and Protocol selected (refer to the appropriate section).
PULSE RATE
The Pulse Rate (hertz or pulses per second) chosen depends greatly upon the
type of electrode placement given to the patient.
When using contiguous and dermatome electrode placements (i.e. stimulating
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Chapter 14 : ELECTRODE PLACEMENT
The placement of electrodes can be one of the most important parameters in
achieving success with TENS therapy. Of utmost importance is the willing-
ness 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 settings suggested here. If the initial results are not
positive,feelfreetoexperiment. Onceanacceptableplacementhasbeenachieved,
mark down the electrodes sites and the settings on the patient s reference sheet
of this manual, so the patient can easily continuetreatment at home.
CONTIGUOUS PLACEMENT
This is the most common placement technique. It involves placing the electrodes
alongside the area of localized pain site, 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 pad on either side
of the pain site if the pain is localized on a limb and deep within the tissue. Pad
placement on the posterior and anterior aspects of the affected limb will allow the
current to flowcompletely through the limb and thus throughthe endogenouspain
site.
With a two channels application, the clinician may either direct the current flow to
cross through thepain site or, inwhat is called the “bracket”method allowing the
currentflowoneithersideofthe painfularea,generallythroughthenervebranches
that feed into the pain site.
Chapter 15 : TIPS FOR SKIN CARE
Toavoidskinirritation,especiallyifyouhavesensitiveskin,followthesesuggestions:
1.Wash the area of skin where you will be placing theelectrodes, using mild soap
and water before applying electrodes, and after taking them off. Be sure to
rinse soap off thoroughly and dry skin well.
Chapter 11 : ATTACHMENT OF ELECTRODE LEAD WIRES
The wires provided with the sys-
tem insert into the jack sockets
located on top of the device. Hold-
ing the insulated portion of the
connector, push the plug end of
the wire into one of the jacks (see
drawing); one or two sets of wires
may be used.
After connecting the wires to the stimulator, attach each wire to an electrode.
Use care when you plug and unplug the wires. Jerking the wire instead of
holding the insulated connector body may cause wire breakage.
CAUTION
Do notinsert theplug of the patient lead wire into the AC power supplysocket.
Chapter 12: LEAD WIRE MAINTENANCE
Clean the wires by wiping with a damp cloth. Coating them lightly with talcum
powder will reduce tangling and prolong life.
Chapter 13 : ELECTRODE OPTIONS
Your clinician will decide which type of electrode is best for your condition.
Follow application procedures outlined in electrode packing, to maintain stimu-
lation and prevent skin irritation. Use the legally marketed TENS electrode is
recommended. The device is completed with standard carbon film adhesive
electrodes in size 5x5cm.
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Saturation with water will reduce the adhesive properties.
Important
1.Do not apply to broken skin.
2.The electrodesshould be discarded when they are no longer adhering.
3.The electrodes are intended for single patient use only.
4.If irritationoccurs, discontinue use and consult yourclinician.
5.Read the instruction foruse of self-adhesive electrodes before application.
Chapter 17 : ADJUSTING THE CONTROLS
1.Slide Cover:
A slide-on panel cover covers the controls for Pulse Width, Pulse Rate, Mode
Selector and Modulation Selector. Your medical professional may wish to set
these controls for you and request that you leave the cover in place.
2.Display Led
Each of the leds illuminates whenever the electronics of the device create a
current impulse. Due to the capacity of the human eye, the illumination of the
lamp can only be recognized up to a frequency of approximately 30 Hz.At
2.Excess hair may be clipped with scissors; do not shave stimulation area.
3.Wipe the area with the skin preparation your clinician has recommended.
Let this dry. Apply electrodes as directed.
4.Many skin problems arise from the “pulling stress”from adhesive patches
that are excessively stretched across the skin during application. To prevent
this, apply electrodes from centre outward; avoid stretching over the skin.
5.To minimize “pulling stress”, tape extra lengths of lead wires to the skin in a
loop to prevent tugging on electrodes.
6.When removing electrodes, always remove by pulling in the direction of hair
growth.
7. It may be helpful to rub skin lotion on electrode placement area whennot
wearing electrodes.
8. Never apply electrodes over irritated or broken skin.
Chapter 16 : APPLICATION OF RE-USABLE SELF DHESIVE
ELECTRODES
Application
1.Clean and drythe skin at the prescribed area thoroughly with soap and water
prior toapplication of electrodes.
2.Insert the lead wire into the pin connector on the pre-wired electrodes.
3.Remove the electrodes from the protective liner and apply the electrodes firmly
to the treatmentsite.
Removal
1.Lift at the edge of electrodes and peel; do not pull on the lead wires because
it may damage the electrodes.
2.Place the electrodes on the liner and remove the lead wire by twisting and
pulling at the same time.
Care and Storage
1.Between uses, store the electrodes in the resealed bag in a cool dry place.
2.It may be helpful to improve repeated application by spreading a few drops
of cold water over the adhesive and turn the surface up to air dry. Over
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5.Mode Control
Expose the controls by sliding front cover down from top of unit. This switch
has 3 positions: B for Burst stimulation, Nfor Constant stimulation, and M for
modulation stimulation. Push the Mode Selector until engaged in position
desired.
6.Pulse Rate Control:
This dial determines howmanyelectrical impulses are applied through the skin
each second. Byturning these controls, the number of current impulses per
second(Hz) for both channels can be continuallyadjusted. Unless otherwise
instructed, turn the pulse rate control to the 70-120 Hzrange.
7.Pulse Width Control:
This dial adjusts the length of time each electrical signal is applied through
the skin, which controls the strength and sensation of the stimulation. If no
instructions regarding the pulse width are given in therapy, set the control to
the suggested 70-120 uS setting.
higher frequencies, the lamp will appear to be constantly illuminated.
3.On/Off Switch and Intensity Control :
If both controls are in the off-position (white markings on the housing), the
device is switched off.
By turning the controls clockwise, the appropriate channel is switched on
and the impulse display led will illuminate and begin to pulse according to
the frequency set.
The current strength of the impulses transmitted to the electrodes increases
further when the control is turned clockwise.
To reduce thecurrent strength or switch the device off , turn the controls counter
clockwise to the requiredsetting oroff- position.
4.Lead Connector
Connection of the electrodes is made with two-lead connector. The device
must be switched off before connecting the cables. Both intensity controls
must be at the Off position. Electrodes must be pressed firmly on the skin.
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The use of any attachment not supplied with the charger may result in the
risk of fire, electric shock, or injury to persons.
(2)Follow the battery manufacturer s instructions for charging time.
(3)After the battery manufacturer s recommended charging time has been
completed, unplug the charger and remove the battery.
(4)Batteries should always be stored in a fully charged state.
To ensure optimum battery performance, follow these guidelines:
(a)Although overcharging the batteries for up to 24 hours will not damage
them,repeated overcharging may decrease useful battery life.
(b)Always store batteries in their charged condition. After a battery has been
discharged, recharge it as soon as possible. If the battery is stored more than
60 days, it may need to be recharged.
(c)Do not short the terminals of the battery. This will cause the batteryto get hot
and can cause permanent damage. Avoid storing the batteries in your pocket
or purse where theterminalsmay accidentallycome into contact with coins,
keys or any metal objects.
(d)WARNINGS:
1. Do not attempt to charge any other types of batteries in your charger, other
than the nickel-cadmium rechargeable batteries. Other types of batteries
may leak or burst.
2. Do not incinerate the rechargeable battery as it may explode!
Chapter 19: MAINTENANCE, TRANSPORTATION
AND STORAGE OF TENS DEVICE
1.Non-flammable cleaning solution is suitable for cleaning the device.
Note: Do not smoke or work withopen lights (forexample, candles, etc.)
when working with flammable liquids.
2.Stains and spots can be removed with a cleaning agent.
3.Do not submerge the device in liquids or expose it to large amounts of water.
4.Return the device to the carrying box with sponge foam to ensure that the
unit is well-protected before transportation.
5.If the device is not to be used for a long period of time, remove the batteries
8.Check/Replace the Battery:
Over time, in order to ensure the functional
safety of TENS, changing the battery is
necessary.
1.Make sure that both intensity controls are
switched to off position.
2.Slide the battery compartment cover and
remove.
3.Remove the battery from the compartment.
4.Insert the battery into the compartment.
Note the polarity indicated on the battery
and in the compartment.
5.Replace the battery compartment cover
and slide to close
Chapter 18 : BATTERY INFORMATION
AGF-3XTENS can be used with a rechargeable battery when necessary.
If you use rechargeable batteries, please follow the instructions.
RECHARGEABLE BATTERIES:
Prior to the useof a new unit, therechargeable battery should becharged accord-
ing to the battery manufacturer s instructions. Before using the battery charger,
read all instructions and cautionary markings on the battery and in this instruction
manual.
After being stored for 60 days or more, the batteries may lose their charge. After
long periods of storage, batteries should be charged prior to use.
BATTERY CHARGING
(1)Plug the charger into any working 110 or 220/240v mains electrical outlet.
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- for possible damage to the cable. Change the cable if any damage is
detected.
* If there is any other problem, please return the device to your distributor. Do
not try to repair a defective device.
Chapter 22 Conformity to Safety Standards
STATEMENTOFEMC
The AGF-3X TENS devices are in compliance with IEC 60601-1-2: 1993.
CONFORMITYTOMDDREQUIREMENTS
The AGF-3X TENS devices are in compliance with IEC 60601-1 safety
Standard and FDA 510K standards.
Chapter 23 : WARRANTY
All AGF-3X TENS models carrya warranty of one year from the date of delivery.
The warranty applies to the stimulator only and covers both parts and labour
relating thereto.
The warranty does not apply to damage resulting from failure to follow the
operating instructions, accidents, abuse, alteration or disassembly by unau-
thorized personnel.
Manufacturer:MEDICAL DEPOT INC DBA DRIVE MEDICAL
99 Seaview Boulevard
Port Washington, NY 11050
Phone # : [phone]
Edition :V1.6
Printedin February , 2007
from the battery compartment (acid may leak from used batteries and
damage the device). Put the device and accessories in carrying box and
keep it in cool dry place.
6.The packed TENS device shouldbe stored and transported under the
temperature range of -20 ~ + 60 , relative humidity 20% ~ 95% , atmo
sphere pressure 500 hPa ~ 1060 hPa.
Chapter 20: SAFETY-TECHNICAL CONTROLS
For safety reasons, check your AGF-3X TENS each week based on the following
checklist.
1.Check the device for external damage.
-deformationof thehousing.
-damaged or defective output sockets.
2.Check the device for defective operating elements.
-legibility of inscriptions and labels.
-make sure the inscriptions and labels are not distorted.
3.Check Led
-led must be illuminated when switched on.
4.Check the usability of accessories.
-patientcable undamaged.
-electrodesundamaged.
Please consult your distributor if there are any problems with device and
accessories.
Chapter 21 MALFUNCTIONS
Should any malfunctions occur while using the TENS, check
- whetherthe switch/control is set to the appropriate form of therapy. Adjust
the control correctly.
- whether thecable is correctly connected to the device. The cables should be
inserted completely into the sockets.
-whether the impulse display led is illuminated. If necessary, insert a new
battery.
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