Drive AGF-5X User manual

PortWashington,NY11050
V1.1
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INDEX
Chapter Contents Page
Index
1. Introduction........................................................................2
2. Cautions.............................................................................3
3. Warnings............................................................................4
4. General Description............................................................5
5. Construction......................................................................5
6. TechnicalSpecifications ..................................................6
7. Replaceable Parts...............................................................7
8. Accessories........................................................................7
9. GraphicSymbols................................................................8
10. ParameterControls............................................................8
11. AttachmentofElectrodesLead Wires..............................10
12. Lead Wire Maintenance ..................................................10
13. Electrode Options.............................................................10
14. Electrode Placement..........................................................11
15. Tips ForSkin Care.............................................................11
16. Application of Re-usable Self Adhesive Electrodes...........12
17. Adjusting the Controls......................................................13
18. Battery Information...........................................................17
19. Maintenance, Transportation and Storage of
TENSDevice.....................................................................18
20. SafetyControl..................................................................18
21. Malfunctions.....................................................................19
22. Conformity to SafetyStandards.......................................19
23. Warranty...........................................................................20
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tion of pain lasts longer thanthe actual periodof stimulation (sometimes as
muchas threetofour times longer).Inothers,painisonly modifiedwhile
stimulationactuallyoccurs. Youmay discussthis withyourphysician or
therapist.
Chapter 2: CAUTIONS
1.Precautions:
Isolated cases ofskin irritation may occuratthe siteof electrode placement
following long-termapplication.Effectiveness is highlydependentupon patient
selection byaperson qualified in the managementofpain patients.
2.Contradictions:
TENS devices can affectthe operation of demand type cardiac pacemakers.
TENSis notrecommended forpatientswithknownheart disease withoutphysi
calevaluationofrisk.Do notuseTENS on thecarotid sinus(neck)region.Dono
apply TENS for undiagnosed pain syndromes until etiologyis established.Do
notstimulateonthesitethatmaycausecurrenttoflowtranscerebrally -(through
thehead).
3.Adverse Reactions
Possible allergic togel,skin irritation and electrode burnarepotential adverse
reactions.
4.Read operation manual beforeuse ofTENS.
5.Weemphasizethatpatient withan implanted electronic device (forexample,a
pacemaker)shouldnotundergoTENStreatmentwithoutfirstconsultingadoctor.
The same applies topatientswithany metallic implants.
6.If TENS therapybecomes ineffectiveor unpleasant, stimulation should be dis
continued until its use is reevaluated bythe physician or therapist.
7.Avoid adjusting controls while operating machineryorvehicles.
8.Turnthe DIGITAL SD TENSoffbefore applying orremoving electrodes.
9.DIGITALSD TENS devices have no AP/APG protection.
Do not use it in the presence of explosive atmosphere and flammable mixture.
Chapter1:INTRODUCTION
EXPLANATIONOFPAIN
Pain is a warning system and the body s method of telling us that something is
wrong.Pain is important; without itabnormal conditions may go undetected,
causing damage orinjurytovital partsofour bodies.
Even though pain is anecessary warning signal of trauma or malfunction in the
body, naturemayhave gonetoofar in its design.Asidefromitsvaluein diagnosis,
long-lasting persistent pain serves no useful purpose.Pain does not begin until
coded message travels tothe brain where it is decoded,analyzed, and then re-
acted to.The pain message travels from the injured area along the small nerves
leading to the spinal cord. Here the message is switched todifferentnerves that
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 Electrical NerveStimulation is anon-invasive,drug-free method
of controlling pain. TENSuses tiny electrical impulses sent through the skin to
nerves to modify your pain perception. TENS does not cure any physiological
problem;itonlyhelpscontrolthepain.TENSdoesnotworkforeveryone;however,
in most patients it is effective in reducing or eliminating the pain, allowing for a
returnto normal activity.
HOW TENS WORKS
There is nothing “magic”about Transcutaneous Electrical NerveStimulation
(TENS).TENSisintendedtobe used torelievepain.TheTENSunitsends
comfortable impulses through the skin thatstimulate the nerve (or nerves) in the
treatmentarea.Inmanycases,this stimulationwillgreatlyreduce or eliminatethe
pain sensation the patientfeels.Pain relief varies byindividual patient, mode se-
lectedfortherapy, and the typeofpain.Inmany patients,the reduction orelimina-
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Chapter 4:GENERALDESCRIPTION
TheAGF-5XDIGITALSDTENSisabattery operatedpulse generator that
sends electrical impulses electrodestothe bodyandreachthe nerves caus-
ingpain.The deviceis provided with two controllable output channels, each
independent of each other. An electrode paircan be connected to each output
channel.
The electronicsof the AGF-5XDIGITALSDTENS create electrical impulses
whose Intensity, duration,numberper second andmodulation may be altered
with the controls/switches. Press buttons arevery easy touse andthelarge
liquid crystal displayshowing the exact mode and valuesof parameters are
very convenient for patients.
Chapter 5 : CONSTRUCTION
LIQUIDCRYSTALDISPLAY
Chapter 3 : WARNINGS
1.Cautionshould beused in applying TENS topatientssuspectedofhavingheart
disease.Furtherclinical datais needed toshow thereareno adverse results.
2.The safety ofTENS devices for use during pregnancy orbirthhas notbeen
established.
Donotuse TENSduring pregnancy.
3. TENSis noteffectiveforpain ofcentral origin. (This includes headache.)
4. TENSdevices should be used onlyunder the continued supervision ofa
physician.
5. TENS devices haveno curativevalue.
6. TENSis asymptomatic treatmentand as such suppresses the sensation of
pain,which would otherwise serveas aprotective mechanism.
7. Electronic monitoring equipment (such as ECG monitorsand ECG alarms)
may not operateproperly when TENSstimulation is in use.
8. Thereshould be aprominently placed statementwarning thatstimulus deliv
ered bythis device maybe sufficienttocause electrocution.Electrical current
of this magnitude must notflow through the thorax because it maycause a
cardiac arrhythmia.
9. Donot place electrodes on the frontofthe throat as spasm of the Laryngeal
and Pharyngeal muscle may occur.
10.Careshould be taken so thatwhen operating potentiallydangerous machinery
the stimulator controls arenotchanged abruptly.
6. Electrodes should notbe placed overthe eyes,in the mouth,orinternally.
11.Keep this device outof the reach ofchildren.
12.Caution:Federal law restricts this device to sale byor on the orderofaphysi-
cian.
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Chapter 7 : REPLACABLE PARTS
ThereplaceablepartsandaccessoriesofDIGITALSD TENSdevices are as
given below –
Exceptleads,electrodes andbattery, battery casecover,please do nottry to
replace theother parts of a device.
PARTS
01 ELECTRODES LEADS
02 ELECTRODES
03 9V BATTERY,TYPE 6F22
04 BELT CLIP
05 BATTERY CASE COVER
06 LEADCONNECTOR
08 MAINPCB
09 INTENSITYKNOB
Chapter 8:ACCESSORIES
Each setAGF-5XTENSare completed with standard accessories and
standard labelas given below
I.Accessories
REF. NO. DESCRIPTION QTY
AGF-101 40 X 40 mm AdhesiveElectrodes 4 pieces
AGF-111N ElectrodesLeads 2 pieces
9VBattery 1piece
InstructionManual 1piece
Carrying Case 1 piece
Chapter 6 :TECHNICAL SPECIFICATIONS
The technical specification details ofAGF-5XDIGITALSDTENS areas follows.
MECHANISM TECHNICAL DESCRIPTION
01. Channel Dual, isolated between channels
02. Pulse Ampulitude Adjustable,0-80mApeakinto 500 ohm load
each channel.
03. Wave Form Asymmetrical Bi-Phasic Square Pulse
04. Voltage 0 to34V (Load: 500 ohm)
05. Power source One 9Volt Battery. (Alkaline, or nickel-
cadmiumrechargable)
06. Size 100 (H) x 60(W) x 21 (T) mm
07. Weight 120gramswith battery.
08. PulseRate Adjustable, from 1 Hz to 150 Hz.
09. PulseWidth Adjustable, from30 to 260 microseconds.
10. Timer Selectable,15, 30and 60minutes.
11. Burst Mode Pulse rate adjustable from 0.5 Hz to 5Hz.
Pulsewidth(adjustable), frequencyfixed=100Hz,
Maxoutput voltage 5 V rms (13 mA rms) or 80
mA Peak to Peak into 500 ohm load.
12. ModulationMode Pulse Width is automatically varied in cycle
pattern.
Mode Amplitude Width Rate Time
(mA) (uS) (Hz)
M Adj. Setting Adj. 10
(0-80) (30-260) (-40%)
S1 Setting Setting Setting 10
(0-80) (- 40%) (1-150)
S2 Setting Setting Setting 9
(0-80) (-70%) (1-150)
13. Max. Charge Per Pulse 20micro-coulombs
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PULSERATE
ThePulseRate(hertzor pulses per second) chosen depends greatlyupon
the type of electrode placement given to thepatient.
When usingcontiguous and dermatomeelectrode placements (i.e.stimulat-
ing
directlythroughtheareaofpainorlocalizedenervation),aquickpulserate(setting
greaterthan 80Hz on the Pulse Rate Control)is desired.The patient should not
perceive individual pulses but rather have the sensationofsteady continuous
stimulation.
Despiteaboverecommendations,theseindividualpatientsmayrequireslightvaria-
tions ofthe above settings,according tothe natureof theircondition.
TREATMENT MODE
NormalorConventionalTENSoffersthe practitionerscompletecontroloverall the
various treatmentparametersofthe instrument.
Burst Mode is analogous to the Low Rate TENS technique except thelowfre-
quencyindividualpulsesarereplacedbyindividual“bursts”of7-10individualpulses.
It isthus a combination ofConventional TENS and Low Rate TENS. In Burst
Mode,the treatmentfrequencyisfixedbythe instrumentandisnotadjustable with
the FrequencyRatecontrol.
Modulated Mode attempts toprevent nerveaccommodation by continuously cy-
cling the treatmentintensity.When using Modulated Mode increase the intensity
only when the unit isatthe maximumintensity of the modulation cycle. Ifthe
intensity isincreased duringalowintensityperiodofthecycle,thepatientmayturn
up the control very slowly, so thattheymayfeel the intensity anyhigher.
TIME DURATION
The onset of pain relief should occurshortly after the intensity setting has been
determined.However,in some cases,pain reliefmaytake as long as 30 minutes
toachieve.TENS unitsare typicallyoperated forlong periods oftime,with amini-
mum of20 –30 minutesand in somepost-operation protocols, aslong as 36
hours.
Ingeneral,painreliefwilldiminishwithin30minutesofthecessationofstimulation.
II.LABEL Thelabel attachedto the back ofdevice
contains important messageabout this
device- model,serial number, supply
voltage,CEnumberandclassification.
Pleasedo notremove.
Chapter 9 : GRAPHICSYMBOLS
1. NoteOperating Instructions
2. Degree of Electrical Protection BF
3. Donotinsertthe plug intoACpowersupply socket.
4. Pulse Rate
5. Pulse Width
6. Increase Parameter
7. Decrease Parameter
Chapter 10 : PARAMETERCONTROLS
PULSE DURATION
Widerpulse duration settings will deliverstrongerstimulation foranygiven inten-
sity setting.As mentionedin the Controlssection,byusingacombinationofinten-
sity and pulseduration,itisfeltthatvariouspulsewidths arecapable ofstimulating
differentgroups ofnervefibres.
The choice of which pulse duration to use is partially dependentupon the Treat-
ment Mode and Protocol selected (referto the appropriatesection).
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Chapter 14: ELECTRODE PLACEMENT
Theplacement ofelectrodes can beone ofthemostimportant parametersin
achieving success with TENS therapy.Ofutmost importance is the willing-
ness of theclinician totrythe various styles of electrode placementtofind
whichmethod bestfits the needsofthe individualpatient.
Every patient responds to electrical stimulation differently and their needs may
vary from the conventional settings suggested here. If the initial resultsare not
positive,feelfreetoexperiment. Onceanacceptableplacement hasbeenachieved,
markdownthe electrodes sites and the settings on the patientsreference sheet
ofthis manual,so the patient can easilycontinue treatmentathome.
CONTIGUOUSPLACEMENT
This is the mostcommon placementtechnique.It involves placing the electrodes
alongside the areaof localized pain site, in such away asto direct the flow of
currentthrough oraround the area of pain.
Inasingle channel application,this would involveplacing each pad on eitherside
of the pain siteif the pain is localized on alimb and deep within the tissue. Pad
placementon the posteriorand anterioraspectsofthe affected limb will allowthe
currenttoflowcompletelythrough thelimband thus through theendogenouspain
site.
With atwochannels application,the clinician may eitherdirectthe current flowto
cross through the pain site or,in whatis called the“bracket”method allowing the
currentflowoneithersideofthepainfularea,generallythroughthenervebranches
thatfeed intothe pain site.
Chapter 15: TIPSFOR SKINCARE
Toavoidskinirritation,especiallyifyouhavesensitiveskin,followthesesuggestions:
1.Wash the area ofskin whereyouwill be placing the electrodes,usingmild soap
and water before applying electrodes, and aftertakingthem off. Be sure to
rinsesoap offthoroughlyand dry skin well.
Chapter 11 : ATTACHMENTOFELECTRODE LEADWIRES
Thewires provided with the system insert into the jack sockets located on top
of the device. Holding the insulated portionof the connector, push the plug
end of the wire intoone of the jacks (see drawing); one or twosets of wires
may beused.
Afterconnectingthe wirestothe stimulator, attach eachwire to anelectrode.
Usecare whenyou plugandunplugthe wires.Jerkingthewire insteadof
holdingtheinsulatedconnectorbody maycause wire breakage.
CAUTION
Do not insert the plug of the patient lead wire into the AC power supply socket.
Chapter 12: LEAD WIRE MAINTENANCE
Clean the wires by wiping with a damp cloth. Coating them lightly with talcum
powderwill reduce tangling and prolong life.
Chapter13 : ELECTRODE OPTIONS
Yourclinician will decide which type ofelectrode is bestforyourcondition.Follow
application procedures outlined in electrode packing,to maintain stimulation and
preventskin irritation.Usethe legallymarketedTENS electrodeis recommended.
The device is completed with standard carbon film adhesiveelectrodes in size
5x5cm.
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Care and Storage
1.Between uses,store the electrodesinthe resealed bagin a cool dryplace.
2.It may be helpful toimprove repeatedapplicationbyspreading a fewdrops
of cold water over the adhesive and turn the surface up to air dry. Over
Saturationwithwaterwillreduce theadhesiveproperties.
Important
1.Donotapplyto broken skin.
2.The electrodes should be discarded when theyareno longeradhering.
3.The electrodes are intended forsingle patientuse only.
4.If irritation occurs,discontinue use and consultyour clinician.
5.Read the instruction foruse ofself-adhesiveelectrodes beforeapplication.
Chapter 17:ADJUSTING THE CONTROLS
1.Slide Cover
Aslide-onpanelcoversthebuttonscontrollingpulsewidth,pulserateandmode.
Yourmedical professional maywish tosetthese controls for you and request
thatyou leavethe coverin place.
2.Power On/OffSwitch and IntensityControl
If bothcontrols arein the off-position ,device is
switched off.
Byturning the controls clockwise,the power will be
switched on.A black dotwill be revealed on the LCD
as soon as the stimulation is commenced.
The current strengthof the impulses transmitted to the
electrodes increases furtherwhen the control is turned
clockwise.
Toreduce the currentstrengthorswitch the device off,
turnthe control counterclockwise to the required
setting oroff-position,respectively.
2. Excesshair maybe clippedwith scissors; donot shavestimulationarea.
3. Wipetheareawiththeskinpreparation your clinicianhasrecommended.
Let this dry. Apply electrodes as directed.
4. Many skinproblems arisefromthe “pulling stress”from adhesive patches
that are excessively stretched acrossthe skin during application.To
prevent this, apply electrodes from centre outward; avoid stretching overthe
skin.
5. To minimize “pulling stress”, tape extralengths of lead wires to the skin in a
loop toprevent tuggingon electrodes.
6. When removing electrodes, always remove bypulling in the direction of hair
growth.
7. It may be helpful to rub skin lotion onelectrode placement areawhen not
wearing electrodes.
8. Never apply electrodes over irritated orbrokenskin.
Chapter 16 : APPLICATIONOF RE-USABLESELF
ADHESIVEELECTRODES
Application
1.Clean and dry the skin atthe prescribed area thoroughlywithsoap and water
prior toapplication ofelectrodes.
2.Insert the lead wireintothe pin connectoron the pre-wired electrodes.
3.Remove the electrodes from the protectivelinerand applythe electrodes firmly
tothe treatment site.
Removal
1.Liftatthe edge ofelectrodes and peel;do notpull on the lead wires because it
may damage the electrodes.
2.Place the electrodes on the linerand remove
the lead wirebytwisting and pull ing atthe
same time.
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5.Pulse RateControl
Pulse rateis adjustable from 2Hzto150 Hz.Itsvalue is visible on the LCD.
This buttons determinehowmanyelectrical impulses are applied through
theskin each second. By pressingthesecontrols,thenumber ofcurrent
impulses per second (Hz) forbothchannelscanbecontinually adjusted.
Unless otherwiseinstructed,turn thepulserate controltothe70-120 Hz
range.
A. Increase
When pressing this button,the pulse ratewill increase gradually.
B.Decrease
When pressing this button,the pulse ratewill decrease gradually.
6.PulseWidth Control
Pulse Widthisadjustablefrom 30 uS to260uS. Itsvalue isvisible onthe
LCD. Thesebuttons adjuststhelength of timeeachelectrical signal is
appliedthroughthe skin,which controls thestrengthandsensationofthe
stimulation. Ifno instructions regardingthepulsewidth aregiven in
therapy, set the control to the suggested70-120 uSsetting.
3.LeadConnector
Connection ofthe electrodesis madewithtwo-leadconnector. Thedevicemust
be switched off beforeconnecting the cables.Bothintensity controls mustbe at
the Offposition.Electrodes must be pressed firmly on the skin.
4.ModeControl
Expose the controls by sliding frontcoverdownfrom top ofunit.This button
controlling5modes:Bforburststimulation,Nforconstantstimulation,andMfor
pulse widthmodulation stimulation,S1forintensityand pulse ratemodulation,
S2 forintensityand pulse widthmodulation.Press the button until engaged in
modedesired.
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Chapter 18: BATTERYINFORMATION
AGF-5XTENS can be usedwitha rechargeable battery when necessary.
Ifyou use rechargeablebatteries, pleasefollow theinstructions.
RECHARGEABLE BATTERIES:
Priortothe use ofanewunit, the rechargeable battery should be charged accord-
ing to the battery manufacturer sinstructions. Before using the battery charger,
read all instructions and cautionary markings on the battery and in this instruction
manual.
Afterbeing stored for60 daysormore, the batteries maylose their charge. After
long periods ofstorage,batteries should be charged prior touse.
BATTERYCHARGING
(1) Plugthe chargerintoanyworking 110or220/240v mains electricaloutlet. The
use of any attachment not supplied withthe chargermay resultin the risk of
fire, electric shock,or injuryto persons.
(2) Followthe batterymanufacturersinstructions forcharging time.
(3) Afterthe battery manufacturersrecommended charging time has been
completed,unplug the chargerand removethe battery.
(4) Batteriesshould always be storedin a fully charged state.
To ensure optimum batteryperformance,followtheseguidelines:
(a) Although overchargingthe batteriesforupto 24 hours willnot damage
them, repeated overchargingmay decrease usefulbatterylife.
(b) Always storebatteries in their charged condition.Aftera battery has been
discharged, recharge itas soon aspossible.If thebattery isstoredmore
than 60 days, it may need tobe recharged.
(c) Do not shortthe terminals of the battery. This willcause the battery toget
hot and can cause permanent damage. Avoid storing the batteries in your
pocket orpurse where the terminalsmay accidentallycome into contact
with coins,keys or any metal objects.
A. Increase
When pressingthis button,the pulsewidthwill increasegradually.
B.Decrease
Whenpressing this button, thepulse rate will decreasegradually.
7.Thedevice willstore themode thatisused before itis switched off
automatically.
8.Timer
There is a timer on the right side of unit.The treatment time is selectable at
15,30 and 60 minutes.Push the switch when the desired position is reached.
Output will be shut off when time is up. Turn off the power when output is
terminated.
9.Check / Replace the Battery:
Over time, in order to ensure the functional safety of TENS,
changing thebattery is necessary.
1.Make sure that both intensity controls are switched to
offposition.
2.Slide the battery compartmentcoverand open.
3.Removethe battery fromthe compartment.
4.Insert the battery into the compartment. Notethe
polarity indicated on the battery and in the
compartment.
5.Replacethebattery compartmentcover and press
toclose.
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-makesuretheinscriptions and labels are not distorted.
3.Checktheusabilityofaccessories.
-patientcableundamaged.
-electrodesundamaged.
Please consult yourdistributor if there are any problems with device and
accessories.
Chapter 21 :MALFUNCTIONS
Shouldanymalfunctions occur while using theAGF-5XDIGITALSD TENS,
check
-whether the parametersare set to the appropriateform of therapy. Adjust the
control correctly.
- whetherthe cable is correctlyconnected tothe device.The cables should be
inserted completely into the sockets.
-whetherthe LCDreveal the menu. If necessary, insert anew battery.
- forpossible damage tothe cable.Change the cable ifany damage isdetected.
*If thereis anyotherproblem, please return the device toyourdistributor.Do
nottry torepairadefectivedevice.
CChapter 22 Conformityto SafetyStandards
STATEMENTOFEMC
The AGF-5X TENS devices are in compliance with IEC 60601-1-2: 1993.
CONFORMITYTOMDDREQUIREMENTS
The AGF-5X TENS devices are in compliance with IEC60601-1 safety standard.
(d) WARNINGS:
1.Do not attempt to charge any other types of batteries in your charger,
otherthan thenickel-cadmium rechargeable batteries. Other typesof
batteries mayleak or burst.
2.Do not incineratetherechargeable battery as it may explode!
Chapter 19: MAINTENANCE, TRANSPORTATION
ANDSTORAGE OF TENSDEVICE
1.Non-flammable cleaning solution is suitable for cleaning the device.
Note:Donot smoke orworkwithopen lights(forexample,candles, etc.)
when working withflammable liquids.
2.Stains and spots can be removed with acleaning agent.
3.Donot submerge the device in liquids or expose itto large amountsofwater.
4.Returnthe device tothe carrying boxwithsponge foam toensurethatthe
unit is well-protected beforetransportation.
5.If the device is notto be used foralong period of time, remove the batteries
from the battery compartment (acid may leak from used batteries and damage
the device). Putthe device and accessories in carrying box andkeep itin cool
dry place.
6.The packed TENS device should bestored andtransportedunderthe tempera-
ture range of -20 J~ + 60 J, relative humidity 20% ~95% , atmosphere
pressure500 hPa~1060 hPa.
Chapter20: SAFETY-TECHNICALCONTROLS
For safetyreasons, checkyour AGF-5XDIGITALSD TENS each weekbased
onthefollowingchecklist.
1.Check thedevice forexternaldamage.
-deformation of thehousing.
-damaged ordefectiveoutput sockets.
2.Check the devicefor defectiveoperating elements.
-legibilityofinscriptionsand labels.
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Chapter 23 : WARRANTY
All AGF-5XSDTENSmodels carry awarranty of three year from the date
ofdelivery. Thewarranty applies tothestimulator onlyandcovers bothparts
andlabour relatingthereto.
The warranty does not applyto damage resulting from failure tofollow the
operating instructions, accidents, abuse, alteration or disassembly by unautho-
rized personnel.
Manufacturer:DriveMedical Design & Manufacturing
99Seaview Boulevard
Port Washington, NY11050
Phone #: [phone]
Printed in July 2006.
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