Drive AGF-602 User manual

PortWashington,NY11050
V1.3
PDF created with FinePrint pdfFactorytrial version http://www.pdffactory.com

1
INDEX
Chapter Contents Page
Index..................................................................................1
1. Introduction .. ..2
2. Cautions ..... .3
3. Warnings ..... 4
4. General Description ..... 5
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
PDF created with FinePrint pdfFactorytrial version http://www.pdffactory.com

32
lected for therapy, and the type of pain. In many patients, the reduction or
elimination 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.
Chapter 2: CAUTIONS
1.Precautions:
Isolated cases of skin irritation may occur atthe site ofelectrode placement
following long-term application. Effectiveness is 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.
TENS isnot recommended forpatients with known heart disease withoutphysi-
calevaluationofrisk.DonotuseTENSonthecarotidsinus(neck) region.Dono
apply TENS for undiagnosed pain syndromes until etiology is established. Do
notstimulateonthesitethatmaycausecurrenttoflowtranscerebrally -(through
thehead).
3.AdverseReactions
Possible allergic to gel, skin irritationand 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 appliesto patients with anymetallic implants.
6.If TENS therapy becomes 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.T.E.N.S. devices have no AP/APG protection.
Do not use it in the presence of explosive atmosphere and flammable mixture.
Chapter 1 : INTRODUCTION
EXPLANATION 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 tovital parts of ourbodies.
Even though pain is a necessary warning signal of trauma or malfunction in the
body,naturemayhavegonetoofarinitsdesign. Asidefromitsvalueindiagnosis,
long-lasting persistent pain serves no useful purpose. Pain does not begin until
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 the small nerves
leading to the spinal cord. Here the message is switched to different nerves 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 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. TENSdoesnotworkforeveryone;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. Inmany cases,this stimulation willgreatly reduce or eliminatethe
pain sensation the patient feels. Pain relief varies by individual patient, mode se-
PDF created with FinePrint pdfFactorytrial version http://www.pdffactory.com

54
Chapter 4: GENERAL DESCRIPTION
The AGF-602 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-602 TENS 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 slide cover
prevents accidental changes in the setting.
Chapter 5 : CONSTRUCTION
Chapter 3 : WARNINGS
1. Cautionshouldbeused inapplyingTENStopatientssuspectedofhavingheart
disease. Further clinical data is needed to show there are no adverse results.
2. The safetyof TENSdevices for use during pregnancy orbirth has not been
established.
Do not use TENS duringpregnancy.
3. TENS is not effective for pain of central origin. (This includes headache.)
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 inuse.
8. There should be a prominently placed statement warning that stimulus deliv
eredby this device may be sufficient to cause electrocution. Electrical current
of this magnitude must not flow through the thorax because it may cause a
cardiacarrhythmia.
9. Do not place electrodes on the front of thethroat as spasm of the Laryngeal
and Pharyngeal muscle may occur.
10.Careshould betaken so that when operatingpotentially dangerousmachinery
the stimulator controls are not changed abruptly.
6. Electrodes should not be placed over the eyes, in the mouth, or internally.
11.Keep this device out of the reach of children.
12.Caution: Federallawrestricts thisdevice to sale by or on the order of a physi-
cian.
PDF created with FinePrint pdfFactorytrial version http://www.pdffactory.com

76
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 tryto re-
place the other parts of a device.
NO. PARTS
01 ELECTRODES LEADS
02 ELECTRODES
03 9VBATTERY ¡ATYPE 6F22
04 BELTCLIP
05 BATTERY CASE COVER
06 LEAD CONNECTOR
07 MAINPCB
08 INTENSITYKNOB
09 B-N-MSWITCH
10 PULSEWIDTH KNOB
11 PULSE RATE KNOB
12 TIMERSWITCH
Chapter 8 : ACCESSORIES
Each set AGF-602 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
Instruction Manual 1 piece
Carrying Case 1 piece
Chapter 6 : TECHNICAL SPECIFICATIONS
The technical specification details of AGF-602 TENS are as follows.
MECHANISM TECHNICAL DESCRIPTION
1. Channel Dual, isolated betweenchannels
2. Pulse Ampulitude Adjustable, 0-80 mA peak into 500 ohm load
eachchannel
3. Pulse Rate Adjustable, from 2 to 150 Hz
4. PulseWidth Adjustable, from 30 to 260 microseconds
5. ModulationMode Pulse width is automaticallyvaried in cycle
pattern overan interval of nominally 6.5 seconds.
1.Pulsewidth decreases linearly over a period of
0.5 sec. From the control settingvalue to a
value which is 60% less.
2.This narrower pulse width is maintained for 2
seconds and then increased linearly over a
0.5 second period to its original value.
3.Pulse width is maintained for 3.5 sec. at the
controlsettingvalue.
4.The cycle is then repeated.
6. BurstMode Bursts occur twice very second. Pulse
width(adjustable), frequency = 100 Hz
7. Timer Selectable, 15, 30 and 60 minutes.
8. Wave Form Asymmetrical Bi-Phasic Square Pulse
9. Voltage 0 to 34 V (Load : 500 ohm)
10. Max. Charge per pulse 20 micro-coulombs
11. BurstMode One 9 Volt Battery.(alkaline, or nickel-cadmium
rechargable)
12. BatteryLife Approximately 50 hoursat nominal settings.
13. Size 95(H) x 65(W) x 23.5(T) mm
14. Weight 115 grams(battery included)
PDF created with FinePrint pdfFactorytrial version http://www.pdffactory.com

98
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
NormalorConventionalTENSoffersthepractitioners completecontrolover allthe
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,thetreatment frequencyisfixedbytheinstrument 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,thepatientmayturn
up the control very slowly, so that they mayfeel 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.
Ingeneral,painreliefwilldiminishwithin30minutesofthecessationofstimulation.
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
PULSEDURATION
Wider pulse duration settings will deliver stronger stimulation for any given
intensity setting. As mentioned in the Controls section, by using a combina-
tion of intensity and pulse duration, it is felt that various pulse widths are
capable of stimulating different groups of nerve fibres.
The choice of which pulse duration to use is partially dependent upon the Treat-
ment Mode and Protocol selected(referto 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
PDF created with FinePrint pdfFactorytrial version http://www.pdffactory.com

1110
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 easilycontinue treatment at home.
CONTIGUOUS PLACEMENT
This is the most common placement technique. Itinvolves 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 flow completelythrough the limband thus through the 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
currentflowoneithersideofthepainful area,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 the electrodes, 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 system insert into the jack sockets located on top
of the device. Holding 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 plugand unplug the wires. Jerking the wire instead of holding the
insulated connector body may cause 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
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 stimulation 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.
PDF created with FinePrint pdfFactorytrial version http://www.pdffactory.com

1312
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
Saturation with water will reduce the adhesive properties.
Important
1.Do not apply to broken skin.
2.The electrodes should bediscarded when theyare no longer adhering.
3.The electrodes areintended for single patientuse only.
4.If irritationoccurs, discontinue use and consult your clinician.
5.Readthe instruction foruse of self-adhesive electrodesbefore 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 ca-
pacity of the human eye, the illumination of the lamp
can only be recognized up to a frequency of approximately 30 Hz. At higher f
requencies, the lamp will appear to be constantly illuminated.
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 pre-
vent 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 rubskin lotion on electrode placement area when not
wearing electrodes.
8. Never applyelectrodes over irritated or broken skin.
Chapter 16: APPLICATION OF RE-USABLE SELF ADHESIVE
ELECTRODES
Application
1.Clean and dry the skin at the prescribed area thoroughly with soap and water
prior to application of electrodes.
2.Insert the lead wire into the pin connectoron the pre-wired electrodes.
3.Remove the electrodes from the protective liner and apply the electrodes firmly
to the treatment site.
Removal
1.Lift at the edge ofelectrodes andpeel; 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 pull-
ing atthe same time.
Care and Storage
1.Between uses, store the electrodes in the resealed bag in a cool dry place.
PDF created with FinePrint pdfFactorytrial version http://www.pdffactory.com

1514
6. Pulse Rate Control:
This dial determines howmanyelectricalimpulses are applied through the skin
each second. Byturning these controls, the number of current impulses per
seconds (Hz) for both channels can be continually adjusted. Unless otherwise
instructed, turn thepulse rate control to the 70-120 Hzrange.
7.PulseWidth Control:
This dial adjusts the length of time each electrical signal is applied through the
skin, which controlsthe strength and sensationof the stimulation. Ifno instruc-
tionsregarding the pulse widtharegivenin therapysetthe controlto thesug-
gested 70-120 uS setting.
8.Timer Control
Treatment time of TENS can be preset with timer control.
This switch has 3 positions, 15, 30 and 60 minutes.
Push the timer control until engaged in position desired.
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 fre quency set.
The current strength of the impulses transmitted to the electrodes increases
further when the control is turned clockwise.
To reduce the current strength orswitchthe device off, turn the controls counter
clockwise to the required setting or off- 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 controlsmust be at
the Off position. Electrodes mustbe pressed firmly on the skin.
5.Mode Control
Expose the controls by sliding front coverdown from top of unit. This switch has
3 positions: B for Burst stimulation, N for Constant stimulation, and M for
modulation stimulation. Push the Mode Selector until engaged in position
desired.
PDF created with FinePrint pdfFactorytrial version http://www.pdffactory.com

1716
BATTERYCHARGING
(1) Plug the charger into any working 110 or 220/240v mains electrical outlet.
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 shouldalways 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 mayneed to be recharged.
(c) Do not short the terminals of the battery. This will cause the battery to get
hot and can cause permanentdamage. Avoid storingthe batteries in your
pocket or purse where the terminals may accidentally come 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,
otherthan 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 with open lights (for example, 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.
9.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-602 TENS can be used with a rechargeable battery when necessary.
If you use rechargeable batteries, please follow the instructions.
RECHARGEABLEBATTERIES:
Prior to the use of a new unit, the rechargeable battery should be charged
according 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.
PDF created with FinePrint pdfFactorytrial version http://www.pdffactory.com

1918
- whether the cable is correctly connected to the device. The cables should be
inserted completely into the sockets.
- whether theimpulsedisplayledisilluminated.Ifnecessary,insert anewbattery.
- for possible damage tothe cable. Change the cable if anydamage is detected.
* If thereis any other problem, please return the device to your distributor. Do
not try to repair a defective device.
Chapter 22 Conformity to Safety Standards
STATEMENT OF EMC
The AGF-602 TENS devices are in compliance with IEC 60601-1-2: 1993.
CONFORMITY TO MDD REQUIREMENTS
The AGF-602 TENS devices are in compliance with
IEC60601-1 safety standard and FDA 510K standards.
Chapter 23 : WARRANTY
AllAGF-602 TENS models carry a warranty of three 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 un-
authorized personnel.
Manufacturer: MEDICAL DEPOT INC DBA DRIVE MEDICAL
99 Seaview Boulevard
Port Washington, NY 11050
Phone # : [phone]
Edition : V1.1
Printed in February , 2007
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
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 should be stored and transported under the tem-
pera ture range of -20 J~ + 60 J, relative humidity 20% ~ 95% , atmosphere
pressure 500 hPa ~ 1060 hPa.
Chapter 20: SAFETY-TECHNICAL CONTROLS
For safety reasons, check your AGF-602 TENS each week based on the fol-
lowing checklist.
1.Check the device for external damage.
- deformationof thehousing.
- damaged or defective output sockets.
2.Check the device fordefective operating elements.
- legibilityof 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.
- patientcableundamaged.
- 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
- whether the switch/control is set to the appropriate form of therapy. Adjust
the control correctly.
PDF created with FinePrint pdfFactorytrial version http://www.pdffactory.com