Drive AGF-6X User manual

PortWashington,NY11050
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INDEX
Chapter Contents Page
Index ..................... .1
1. Introduction. 2
2. Cautions . .2
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............ .....9
11. Attachment of Electrodes Lead Wires . ..11
12. Lead Wire Maintenance . ....11
13. Electrode Options ....11
14. Electrode Placement..... ..12
15. Tips For Skin Care.... ..13
16. Application of Re-usable Self Adhesive Electrodes . ...14
17. Adjusting the Controls.... ...15
18. Battery Information... ..19
19. Maintenance, Transportation and Storage of DIGITAL
EMS Device.........................................................................21
20. Safety Control..... .....21
21. Malfunctions . ..22
22. Conformity to Safety Standards ...22
23. Warranty/ Manufacturer/ Representative in the EU..... ...23
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Chapter1:INTRODUCTION
EXPLANATIONOF DIGITALEMS
ElectricalMuscleStimulationisaninternationallyacceptedandprovenwayoftreat-
ing muscularinjuries.It works bysendingelectronic pulses tothemuscle needing
treatment;this causes the muscle to exercise passively.
Itis aproductderivedfromthe squarewaveform,originally invented byJohnFara-
dayin 1831.Through the squarewavepatternitis able toworkdirectlyon muscle
motor neurons.DIGITALEMShas lowfrequency and this in conjunction with the
squarewavepatternallowsdirectworkon muscle groupings.This is being widely
used in hospitals and sports clinics forthe treatmentofmuscularinjuries and for
the re-education of paralyzed muscles, to prevent atrophy in affected muscles
and improving muscle tone and blood circulation.
HOWDIGITALEMS WORKS
DIGITALEMS is intended to be used to increase blood circulation and loosens
tight and knotted fibers, stimulates muscle growthand also reduces stiffness in
muscle joints. The DIGITALEMS units send comfortable impulses through the
skin that stimulatethe nerves in the treatment area. When the muscle receives
thissignalitcontracts asifthebrainhassentthesignalitself.As thesignalstrength
increases,themuscleflexesas inphysicalexercise.Then whenthepulse ceases,
the muscle relaxes and the cycle startsoveragain,(Stimulation,Contraction and
Relaxation.)
Chapter 2 : CAUTIONS
1.Precautions:
Isolated cases ofskin irritation may occuratthe siteof electrode placement
following logn-termapplication.Effectiveness is highlydependentupon patient
selection byaperson qualified in the managementofpain patients.
2.Contradictions:
TENSdevices can affect the operation of demand type cardiac pacemakers.
TENS isnotrecommended forpatientswithknownheart disease withoutphysi-
calevaluationofrisk.DonotuseTENS on thecarotid sinus(neck)region.Do no
apply TENS for undiagnosed pain syndromes until etiologyis established.Do
not stimulateon the sitethatmaycause current toflowtranscerebrally(through
thehead).
3.Adverse Reactions
Possible allergic togel,skin irritation and electrode burnarepotential adverse
reactions.
4.Read operation manual beforeuse ofEMS.
5.Weemphasizethatpatient withan implanted electronic device (forexample,a
pacemaker)shouldnotundergoEMStreatmentwithoutfirst consultingadoctor.
The same applies topatientswithany metallic implants.
6.If EMS therapybecomes ineffectiveorunpleasant, stimulation should be dis
continued until its use is reevaluated bythe physician or therapist.
7.Avoid adjusting controls while operating machineryorvehicles.
8.Turn the T.E.N.S.off beforeapplying orremoving electrodes.
9.AGF-3XT.E.N.S.devices haveno AP/APG protection.
Donot use itin the presence ofexplosiveatmosphereand flammable mixture.
Chapter 3 : WARNINGS
1.Caution should be used in applying EMStopatientssuspected ofhaving heart
disease.Furtherclinical datais needed toshow thereareno adverse results.
2.The safety of EMSdevices foruse during pregnancyorbirthhas notbeen
established.
Donotuse EMSduring pregnancy.
3.EMSis noteffective for pain ofcentral origin.(This includes headache.)
4.EMSdevicesshouldbeusedonlyunder thecontinuedsupervisionofaphysician.
5.EMSdevices haveno curativevalue.
6.EMSis asymptomatic treatmentand assuch suppresses the sensation ofpain
which would otherwise serve as aprotectivemechanism.
7.Electronicmonitoring equipment (suchasECGmonitors andECG alarms)
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maynotoperateproperlywhen EMS stimulationis inuse.
8. Thereshould be aprominentlyplaced statementwarning thatstimulus deliv-
ered bythis device maybe sufficient tocause electrocution.Electrical current
of this magnitude must notflow through the throax 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 betaken sothatwhenoperatingpotentiallydangerous machinery
the stimulator controls arenotchanged abruptly.
6.Electrodes should notbe placed over the eyes,in the mouth, orinternally.
11. Keep this device outof the reach ofchildren.
12. Caution:Federal lawrestrictsthis device tosale by or on the orderofaphysi
cian
Chapter 4 :GENERAL DESCRIPTION
TheAGF-6X DIGITALEMSisabatteryoperated pulse generator that sends
electrical impulses through electrodes to the body andreaches the underlying
nervesor muscle group. The deviceis provided withtwocontrollable output
channels,eachindependentof each other.An electrode pair canbe con-
nectedto each outputchannel.
The electronics of the AGF-6X DIGITALEMS create electrical impulses whose
Intensity, Pulse Width, Pulse Rate, Contraction, Relaxation and Ramp may be
altered with the switches. Press buttons are veryeasyto use and the slide
cover preventsaccidental changes in thesetting.
Chapter 5:CONSTRUCTION
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Chapter 6 : TECHNICALSPECIFICATION
Thetechnical specificationdetails of AGF-6X DIGITALDIGITALEMS areas
follows.
MECHANISM TECHNICAL DESCRIPTION
01. Channel Dual, isolated between channels.
02. Intensity Control Adjustable 0-90mA, Max output 90mA peak to
peak(17.8mArms) into 500ohm load each
channel.
03. Wave Form Asymmetrical Bi-PhaseSquare Pulse
04. Voltage Adjustable 0-45V,Max output45V peak topeak
(8.9Vrms)into500ohmloadeachchannel.
05. PowerSupply One 9Vbattery.
06. Size 10cm (L) x 6 cm(W)x 2.1cm(H)
07. Weight 120gramswith battery
08. PulseRate Adjustable, from 1 Hz to 150 Hz
09. PulseWidth Adjustable, from 30 uS to 260 uS
10. Contraction Time Adjustablefrom 1- 30 seconds
11. Relaxation Time Adjustablefrom 1- 30 seconds
12. Ramp Time Adjustable from 1 - 6seconds
13. Timer Adjustable: 1 - 60 minutes.
14. Max. Charge per pulse 20 micro coulombs
15. Battery Life Approximately25hoursat nominal settings
Chapter 7 : REPLACABLE PARTS
Thereplaceable parts andaccessoriesof DIGITALEMSdevices are as given
below
Exceptleads, electrodes and battery,batterycase cover,please do nottryto re-
place the otherpartsofadevice.
PARTS
01 ELECTRODES LEADS
02 ELECTRODES
03 9VBATTERY ,TYPE 6F22
04 BELT CLIP
05 BATTERY CASE COVER
06 LEADCONNECTOR
07 MAINPCB
08 INTENSITYKNOB
Chapter 8: ACCESSORIES
Each set AGF-6XDIGITALEMSare completed with standard accessories and
standardlabel as given below
I.Accessories
REF. NO. PRODUCT Q’TY
AGF-101 40 X 40 MM Adhesive Electrodes 4 pieces
AGF-111N ElectrodesLeads 2 pieces
9VBattery 1piece
InstructionManual 1 piece
Carrying Case 1 piece
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II.LABEL Thelabelattachedto theback of
devicecontains important message about
this device- model, serial number, sup-
ply voltage,the name ofmanufacturer,CE
numberand classification. Pleasedonotremove.
Chapter 9 : GRAPHICSYMBOLS
1. NoteOperating Instructions
2. Degree of Electrical Protection BF
3. Donot insert the plug intoACpowersupply socket
4. Direct Current (DCpower source)
5. Pulse Rate
6. Pulse Width
7. Timer
8. Parameter Increase
9. Parameter Decrease
Chapter10:PARAMETER CONTROLS
PULSEDURATION
Widerpulse duration settings will deliverstrongerstimulation foranygiven inten-
sity setting.As mentioned in the Controlssection, by usinga combination of
intensity andpulseduration,itisfeltthatvariouspulsewidthsarecapableofstimu-
lating differentmuscles groups.
The wider pulse duration is needed to recruit motor fibres, whereas the narrow
pulse duration is used on the moresensoryfibres.
PULSE RATE
The Pulse Rate (hertz or pulses per second) chosen depends greatly upon the
type ofelectrode placementgiven tothe patient.
When using contiguous and dermatome electrode placements (i.e. stimulating
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.
When using point treatments,it has been suggested that slowpulses be utilized
(less than 10Hz).Withthis setting the patientshould be able toslightlyperceive
individualpulses.
When using multiple electrode placementstrategies, such ascombinations of
pointandcontiguouselectrodeplacements,thequickerpulseratesaresuggested.
Despiteaboverecommendations,theseindividualpatientsmayrequireslightvaria-
tions ofthe above settings,according tothe natureof theircondition.
INTENSITY
Each patientresponds differentlytodifferentlevels ofintensity, due tovarying de-
grees of tissue resistance,enervation,skin thickness,etc. Intensityinstructions
are thereforelimited tothefollowingsettings:
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Perception The intensity is increased sothat the patient can feel the
stimulation, but there isnotanymuscular contraction.
Slight Contraction Intensity is increased to a barely visible muscular contrac-
tion that is notstrong enoughtomoveajoint. Whenusinglowpulserate
settings, thiswill showas individualtwitches.Athigherpulse rates there will
simplybeincreased muscle tension.
Strong muscularcontraction is maybe useful in spastic muscle group.The DIGI-
TALEMScan be used in the circumstances to quickly break the spasm. Use a
quick pulse rate, wide pulse duration and set the intensity to visible contraction
(still within patienttolerance). Twenty orthirty minutes ofsuch atetanizedmuscu-
lar contractionwillgenerallybreakthespasm.Inallcases, if thepatientcomplains
thatthe stimulation is uncomfortable,reduce intensity and cease stimulation.
CONTRACTION /RELAXATION
The contraction time and relaxation time ofDIGITALEMSis adjustable.
Stimulation will continue atthe setting contraction time and cease also at the set-
ting relaxation time. Then the cycle starts over again Stimulation, Contraction
andRelaxation.
RAMP
Inordertoachieveacomfortable exercise and avoid startle because of electrical
shock,eachcontractioncoursemayberampedsothatthesignalcomesongradu-
ally and smoothly. The intensity of electrical current will reach the setting level
within the Ramp time, however,itcan notreach the expected level ifthe contrac-
tion time is less than the ramp time.
TIME DURATION
DIGITALEMSunitsaretypicallyoperatedforlong periods oftime,withaminimum
of20 30 minutes.However, the time is varied subjecttothe treatment required.
Please consultyour physician beforeuse ofDIGITALEMS.
Chapter 11 : ATTACHMENTOFELECTRODE LEADWIRES
Thewires providedwiththesys-
tem insertintothejack sockets
located on top of the device.Hold-
ing the insulated portionof the
connector,push the plugend of
thewire intoone of the jacks (see
drawing);oneor two setsof wires
may beused.
After connecting the wires to the
stimulator,attach eachwiretoanelectrode. Use care when youplug and
unplugthe wires. Jerkingthewireinsteadof holdingthe insulated connec-
torbodymay cause wire breakage.
CAUTION
Donotinsert the plug ofthe patient lead wireintothe AC power supplysocket.
Chapter 12: LEAD WIREMAINTENANCE
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
prevent skin irritation. Use of legallymarketed adhesive electrodesis
recommended.
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Chapter 14 :ELECTRODE PLACEMENT
Theplacement ofelectrodes can beone ofthemostimportant parametersin
achieving success with DIGITALEMS therapy.Ofutmostimportance is the will-
ingnessof the clinician totry the various stylesof electrodeplacement to find
which method bestfitsthe needs ofthe individual patient.
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. Onceanacceptableplacementhasbeenachieved,
markdownthe electrodes sites and the settings on the patient’sReference sheet
ofthis manual,so the patient can easilycontinue treatmentathome.
CONTIGUOUSPLACEMENT
This is the mostcommon placementtechnique.It involves placing the electrodes
alongside the affected muscles or muscle groups, in such away as todirect the
flowofcurrentthrough oraround the area.
DERMATOMES, MYOTOMESANDSCLEROTOMES
Thesearetheregionsofthebodyenervatedby onespinalnerve.Electrodeplace-
mentinvolves bothstimulating across the similarlyenervated area and/orplacing
oneelectrode(orsetofelectrodes) attheaffected siteand anotherelectrode (set)
atthe pointwherethe nerverootjoins the spinal cord.
MOTOR, TRIGGERAND ACUPUNCTURE POINTS
While these pointsofhigh tissue conductivity can differinlocationand in theory of
use, their use as an electrode site is identical. The easiest technique involves
placing one pad directly over the pointand completing the circuit by placing the
second padon some areaon the affected side. Thissecondelectrode site
canbe within a nerve zone, ora master point located betweenthe thumb and
the forefinger onthe dorsal web area betweenthetwo metacarpal bones.
MULTIPLEPLACEMENTSTRATEGIES
Because the DIGITALEMShas twoindependently operated channels, the clini-
cian may take advantage ofconcurrentpad placementstrategies.
Forexample,it is possible to use twodifferentelectrode placementstrategies at
the same time. One channel can be used to directly stimulate the pain site in a
contiguousmanner;theotherchannelcanbeplacedalongtheinvolved dermatome
orutilized forpointtherapy.
Chapter 15: TIPS FORSKINCARE
Toavoidskinirritation,especiallyifyouhavesensitiveskin,followthesesuggestions:
1.Wash the area ofskin whereyouwill be placing the electrodes,usingmild soap
andwaterbeforeapplyingelectrodes,and aftertakingthemoff. Besuretorinse
soap off thoroughlyand dry skin well.
2.Excess hair may be clipped with scissors;do notshavestimulation area.
3.Wipe the area withthe skin preparation yourclinician has recommended.Let
this dry. Apply electrodes as directed.
4.Manyskin problems EMSarise from the“pulling stress”from adhesivepatches
thatare excessivelystretched across the skin during application.Toprevent
this,apply electrodes from centreoutward;avoid stretching overthe skin.
5.Tominimize“pulling stress”,tape extralengthsoflead wires totheskin in aloop
topreventtugging on electrodes.
6.When removing electrodes,always remove bypulling in the direction ofhair
growth.
7.Itmaybe helpful torub skin lotion on electrode placement area when notwear
ing electrodes.
8.Neverapplyelectrodes overirritated or broken skin.
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Chapter 16 : APPLICATION OF RE-USABLE SELF
ADHESIVE ELECTRODES
Application
1.Clean and dry the skin atthe prescribed area thoroughlywithsoap and water
prior toapplication ofelectrodes.
2.Insert the lead wireintothe pin connector nthe 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 removethe lead wirebytwisting and pull
ing atthe same time.
Care and Storage
1.Between uses, storethe electrodes in the resealed bag in acool dry place.
2.It may be helpful toimproverepeated application byspreading afewdrops of
cold wateroverthe adhesiveand turnthe surface up toairdry. OverSaturation
withwaterwillreducethe adhesive properties.
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-adhesive electrodes beforeapplication.
Chapter 17:ADJUSTINGTHE CONTROLS
1.Slide Cover:
A slide-on panelcovers the controls for Contraction Time,
Relaxation Time,Ramp Time,Pulse Width,and Pulse Rate.
Yourmedicalprofessionalmaywish to set these controls
for you and request that you leave the cover in place.
2.Power On/Off Switchand Intensity Controls:
Ifboth controls arein the off-position, the device is switched
off.
By turning the controls clockwise, the appropriate channel
is switched on and the indicator of power (a dot) will reveal
onthe LCD.
The current strength of the impulses transmitted to the electrodes increases
furtherwhen the control is turned clockwise.
Toreduce the currentstrength orswitch the device off,turnthe control counter
clockwise tothe required setting oroff-position,respectively.
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4.LeadConnector
Connection ofthe electrodesis madewithtwo-leadconnector. Thedevicemust
beswitched off beforeconnecting the cables.Bothintensity controls mustbe at
the Off position.Electrodes must be pressed firmly on the skin.
5.Function Selector
Expose the controls by sliding frontcoverdownfrom top ofunit.This button
Controlling the menu on the LCD.When the button is pressed,it can change
menu from contraction time,relaxation time,ramp time, pulse rate,pulse width
totimer.
Theparameterofeachfunctioncanbeadjustedwhenitisrevealedonthemenu.
6.ParameterIncrease Control
This button controlling the increase ofparameter.When pressing this button,
the parameterwill increase.Pressthe buttonuntil thevalue desired is reached.
7.Parameter Decrease Control
Thisbuttoncontrollingthe decrease of parameter.Whenpressing this
button, the parameter will decrease. Press the button until the value desired
is reached.
8.FunctionIndicator
The drawing on the top ofLCD showing the function thatis working.
Each partofthe drawing represents one function of the course.
Ramp Up
Contraction
Ramp Down
Relaxation
The defined area will flash when the device is working on thatfunction.
9. Step to SetParameter
The parameterofatreatmentcourse canbe adjusted according tothe following
steps.
Press “set”button toselectthe function you wish tosetavalue.
a.Turnon the Intensity
Afterthe electrodes areplaced firmlyon skin and the lead wires areplugged in
the socketof device,turnthe on/off control clockwise.The menu will reveal on
LCD.Notice the indication ofpowerand function on the LCD.
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b.SetContractionTime
The contraction time controls the time ofstimulation.By pressingparameter
controls,the contraction time can be pre-set. The range is adjustablefrom 1
second to30 seconds.
c.SetRelaxation Time
The relaxation time determines the time ofrelaxation.The stimulation ceases at
setting relaxation time and then re-start in acycle pattern.The relaxation time of
bothchannels ischanged bypressingtheparametercontrols.The range ofit is
adjustable from 1second to45 seconds.
d.Set Ramp Time
This ramp time controlling the time ofoutput currentthatincrease from 0tothe
setting level, and from the setting value to0.When the ramp time is set,each
contraction may be ramped in orderthatsignals come on and come off gradu-
ally and smoothly. The ramp time is adjustable from 1to8seconds bypressing
theparametercontrols.
e.SetPulse Rate
The pulse ratedetermines howmanyelectrical impulses areapplied through
the skin each second. Bypressing the parametercontrols, the numberof cur-
rentimpulses per second (Hz)forbothchannels can be continually adjusted.
The pulse rateis adjustable from 1Hz to150 Hz.Unless otherwise instructed,
turnthe pulse ratecontrol to the 70-120 Hz range.
f. Set Pulse Width
The pulse widthdetermines the lengthof time.Each electrical signal is ap-
plied through the skin, which controls the strengthand sensation ofthe
stimulation.The pulse widthis adjustable from 2to250 uS.Press the but-
tons until the desired value is reached.
g. SetTimer
The treatmenttime is adjustable from 1to60 minutes.
10.Check/Replace the Battery:
Over time, in order to ensure the functional safety of DIGITALEMS,
changing thebattery is necessary.
1.Make sure thatboth intensity controls are
switched tooff- position.
2.Slide the battery compartment coverand remove.
3.Removethe battery fromthe compartment.
4.Insert the battery into the compartment. Note the
polarity indicated on the battery and in the
compartment.
5.Replace the batterycompartmentcover and slide
to close
Chapter 18:BATTERYINFORMATION
AGF-6XDIGITALEMScan beusedwith 6F22 rechargeablebattery when
necessary. If you userechargeablebatteries,please follow the instructions.
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RECHARGEABLEBATTERIES:
Priorto theuseofanew unit, therechargeable battery shouldbecharged
according to the battery manufacturer’s instructions. Beforeusingthebattery
charger, read all instructions and cautionarymarkings on the batteryand 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)Plug the chargerinto anyworking 110 or220/240vmains electrical outlet. The
use of any attachment not supplied withthe chargermay resultin the risk of
fire, electric shock,or injuryto persons.
(2)Followthe batterymanufacturer’sinstructions forcharging time.
(3)Afterthe battery manufacturer’srecommended charging time has been
completed,unplug the chargerand removethe battery.
(4)Batteries should alwaysbe stored in afully charged state.
Toensureoptimum batteryperformance, follow these guidelines:
(a)Although overcharging the batteries forup to24 hourswill not damage them,
repeated overcharging maydecrease useful battery life.
(b)Alwaysstore batteries in their charged condition.Afterabattery has been
discharged,recharge itas soon as possible.Ifthe batteryis stored morethan
60 days, itmayneed tobe recharged.
(c)Donot short the terminals ofthe battery.This will cause the battery to gethot
and can cause permanent damage.Avoid storing thebatteries in yourpocket
or purse wherethe terminals mayaccidentally come intocontact withcoins,
keysoranymetal objects.
(d)WARNINGS:
1.Donot attemptto charge anyother types ofbatteries in yourcharger,other
thanthenickel-cadmium rechargeablebatteries.Other types ofbatteries
may leak or burst.
2.Do not incineratetherechargeable battery as it may explode!
Chapter 19: MAINTENANCE,TRANSPORTATION
AND STORAGEOF DIGITALEMSDEVICE
1.Non-flammablecleaning solution issuitable for cleaningthedevice.
Note:Donot smoke or workwith open lights (forexample,candles,etc.)
whenworkingwith flammable liquids.
2.Stains andspots canbe removed with a cleaningagent.
3.Do not submerge the device in liquids orexpose it to large amounts of water.
4.Returnthe device tothe carrying box withsponge foam to ensure that the unit
iswell-protectedbeforetransportation.
5.If the device is not to be used for a long period of time, remove the batteries
fromthebatterycompartment(acidmayleak fromused batteries and dam
age the device). Put the device and accessories in carrying boxand keep it
in cool dry place.
6.The packed DIGITALEMS device should be stored andtransported under
the temperature range of -20°C~ +60°C, relative humidity 20%~95%,
Aatmospherepressure 500hPa~1060hPa.
Chapter 20: SAFETY-TECHNICALCONTROLS
For safetyreasons, check yourAGF-6X DIGITALEMSeach week based on the
following checklist.
1.Check thedevice forexternaldamage.
-deformation of thehousing.
-damagedordefective outputsockets.
2.Check the devicefor defectiveoperating elements.
-legibilityofinscriptionsand labels.
-makesuretheinscriptions and labels are not distorted.
3.CheckLCD
-Parametersmust bevisibleontheCLD.
4.Checktheusabilityofaccessories.
-patientcable undamaged.
-electrodes undamaged.
Please consult your distributor ifthere are any problems EMSwith device and
accessories.
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Chapter 21 MALFUNCTIONS
Shouldany malfunctions occur while using the DIGITALEMS,check
-whether the controls or parameters are set to the appropriateformof therapy.
Adjustthe control correctly.
- whetherthe cable is correctly connected 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 ifanydamage isdetected.
*If thereis any otherproblem, please returnthe device toyourdistributor.Do
not try torepair adefectivedevice.
Chapter 22 Conformityto SafetyStandards
STATEMENTOF EMC
The AGF-6X Digital EMS devices are in compliance with IEC 60601-1-2: 1993.
CONFORMITYTOMDD REQUIREMENTS
The AGF-6X Digital EMS devices are in compliance with IEC60601-1 safety
standard and FDA 510K standards.
Chapter 23 : WARRANTY
AllAGF-6X Digital EMS models carryawarranty ofone yearfrom 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: Drive Medical Design & Manufacturing,
99 Seaview Boulevard
Port Washington, NY 11050
Phone # : [phone]
Edition :V1.2
Printed in July , 2005
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