Drive Medical Design AGF-602 User's Manual
Contents
1. 16 Application of Re usable Self Adhesive Electrodes 12 17 Adjusting the Controls cccecceeeeeeeeeeeee eee ee eee eeeeaeenes 13 18 Battery Information ccccceceeee seen ee ee eee eee ee eeeeeeaeenees 16 19 Maintenance Transportation and Storage of TENS Devitt sse 17 20 Safety COntrol scccsce sceciscescstscesivccsdeeeessteeecs see veteeeenvese 18 21 Malfunctions 2 ccccceeec scene eee eee ee ee eee eee eeeeeeneeeeeees 18 22 Conformity to Safety Standards cceceeeeeeeeeeeeteeee 19 23 Warranty cciecicescieneietccic ce saedetd ce ceecees ce see ceed cedenadeenestenctinesvers 19 PDF created with FinePrint pdfFactory trial version http www pdffactory com 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 or injury to vital parts of our bodies Even though pain is a necessary warning signal of trauma or malfunction in the body nature may have gone too far in its design Aside from its value in diagnosis 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 trave2. Despite above recommendations these individual patients may require slight variations of the above settings according to the nature of their condition TREATMENT MODE Normal or Conventional TENS offers the practitioners complete control over all the various treatment parameters of the instrument Burst Mode is analogous to the Low Rate TENS technique except the low fre quency individual pulses are replaced by individual bursts of 7 10 individual pulses It is thus a combination of Conventional TENS and Low Rate TENS In Burst Mode the treatment frequency is fixed by the instrument and is not adjustable with the Frequency Rate 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 intensity is increased during a low intensity period of the cycle the patient may turn 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 cessatio
3. the treatment site 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 pull ing at the same time Care and Storage 1 Between uses store the electrodes in the resealed bag in a cool dry place B 2 lt 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 be discarded when they are no longer adhering 3 The electrodes are intended for single patient use only 4 If irritation occurs discontinue use and consult your clinician 5 Read the instruction for use 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 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 c
4. 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 D BATTERY CHARGING 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 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 battery to get hot and can cause permanent damage Avoid storing the batteries in your pocket or purse where the te
5. NS 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 1 LEAD CONNECTOR 2 INTENSITY CONTROL ON OFF SWITCH 3 PILOT 4 PULSE WIDTH CONTROL 5 MODE CONTROL 6 PULSE RATE CONTROL PULSE WIDTHS q 7 TIMER CONTROL 8 BATTERY STRIP 9 BATTERY CASE PDF created with FinePrint pdfFactory trial version http www pdffactory com Chapter 6 TECHNICAL SPECIFICATIONS Chapter 7 REPLACABLE PARTS The technical specification details of AGF 602 TENS are as follows The replaceable parts and accessories of T E N S devices are as given below MECHANISM TECHNICAL DESCRIPTION Dual isolated between channels Except leads electrodes and battery battery case cover please do not try to re 2 Pulse Ampulitude Adjustable 0 80 mA peak into 500 ohm load place the other parts of a device each channel Pulse Rate Adjustable from 2 to 150 Hz _NO PARTS Pulse Width Adjus
6. UMIYAK AGF 602 Dual Channel Transcutaneous Electrical Nerve Stimulator with Timer Instruction Manual urive MEDICAL DESIGN amp MANUFACTURING Port Washington NY 11050 MEDICAL DESIGN amp MANUFACTURING V1 3 PDF created with FinePrint pdfFactory trial version http www pdffactory com INDEX Chapter Contents Page WIN OX oo vvce cic sece E E E E E 1 Ae INTODU CHONG essari setecnensacesiebeonsenadtenevaednenteccavages 2 2 GCaUtlONS eo soso eosccc cece cavieadevenecdboksaenatel ANANE ANEN RENNA 3 De WANMINGS 5 cccet E T 4 4 General Description cccceeeeeeeeeeeeeeeeeeeseeeeeseeeeseneees 5 5 CONSUUCHOM ye siccccecssateasnaccss cote ssse bens EAEAN ERA RRAS 5 6 Technical Specifications ccceceeeeeeeeeeeeeeeeeeeee eee eee 6 7 Replaceable Parts ccccceceeeeseeeeeeeeeeeeeeeeeeeeeneeeeeeees 7 G ACCOSSOMGS sie s ci ccdesesicsag des caceaarnsdscedventeceeediwdgaceenn cece 7 9 Graphic Symbols sieniniai aena 8 10 Parameter Controls ccccccceeececeeeeeee ee eeeeneeeeeneeneeeee 8 11 Attachment of Electrodes Lead Wires e esseeeee 10 12 Lead Wire Maintenance cccceeeeeeeeeee eens eenneeeeee 10 13 Electrode Options ccccceceeceeeee eee eens eee eeeseeee ea eeeenes 10 14 Electrode Placement 0 ceeeeeeeeeeeeeeeeeeeeeeeneeeees 11 15 Tips For Skin Care ccceceeceeeee eens eee eeeeeeeeeeeseaeeeneneeees 11
7. kin follow these suggestions 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 PDF created with FinePrint pdfFactory trial version http www pdffactory com 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 rub skin lotion on electrode placement area when not wearing electrodes 8 Never apply electrodes 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 connector on the pre wired electrodes 3 Remove the electrodes from the protective liner and apply the electrodes firmly to
8. l 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 Nerve 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 it only helps control the pain TENS does not work for everyone 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 or eliminate the pain sensation the patient feels Pain relief varies by individual patient mode se 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 at the site of electrode placement following long term application Effectivene
9. n of stimulation PDF created with FinePrint pdfFactory trial version http www pdffactory com 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 plug and unplug the wires Jerking the wire instead of holding the insulated connector body may cause wire breakage on WIRE Seenaa SOCKET 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 D 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 cli
10. nician 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 feel free to experiment Once an acceptable placement has been achieved mark down the electrodes sites and the settings on the patient s reference sheet of this manual so the patient can easily continue treatment 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 flow completely through the limb and thus through the endogenous pain site With a two channels application the clinician may either direct the current flow to cross through the pain site or in what is called the bracket method allowing the current flow on either side of the painful area generally through the nerve branches that feed into the pain site Chapter 15 TIPS FOR SKIN CARE To avoid skin irritation especially if you have sensitive s
11. ol lowing checklist 1 Check the device for external damage deformation of the housing 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 patient cable undamaged electrodes undamaged 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 whether the cable 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 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 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 All AGF 602 TENS models carry a warranty of three year from the da
12. onstantly illuminated LED _ COVER PDF created with FinePrint pdfFactory trial version http www pdffactory com 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 or switch the 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 controls must be at the Off position Electrodes must be pressed firmly on the skin PLUG U Ag Jy LEAD CONNECTOR L gt fis 3388 5 Mode Control aa Expose the controls by sliding front cover down 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 D MODE QR 6 Pulse Rate Control This dial determines how many electrical impulses are applied through the skin each second By turning these controls the number of c
13. pdffactory com Il LABEL The label attached to the back of device contains important message about this device model serial number supply voltage CE number and classification Model Serial No AGF 02 gt gt Ta apaan o Please do not remove Chapter 9 GRAPHIC SYMBOLS Note Operating Instructions b A 2 Degree of Electrical Protection BF 3 3 Do not insert the plug into AC power supply socket 4 SS Direct Current DC power source Chapter 10 PARAMETER CONTROLS PULSE DURATION 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 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 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
14. rminals 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 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 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 PDF created with FinePrint pdfFactory trial version http www pdffactory com 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 f
15. ss is highly dependent 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 is not recommended for patients with known heart disease without physi cal evaluation of risk Do not use TENS on the carotid sinus neck region Do no apply TENS for undiagnosed pain syndromes until etiology is established Do not stimulate on the site that may cause current to flow transcerebrally through the head 3 Adverse Reactions 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 should not undergo TENS treatment without first consulting a doctor The same applies to patients with any metallic 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 adjusting controls while operating machinery or 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 PDF created with FinePrint pdfFactory trial version http www pdffactory com Chapter 3 WARNINGS Caution should be used in applying TENS to patients
16. suspected of having heart disease Further clinical data is needed to show there are no adverse results The safety of TENS devices for use during pregnancy or birth has not been established Do not use TENS during pregnancy TENS is not effective for pain of central origin This includes headache TENS devices should be used only under the continued supervision of a physician TENS devices have no curative value TENS is a symptomatic treatment and as such suppresses the sensation of pain which would otherwise serve as a protective mechanism Electronic monitoring equipment such as ECG monitors and ECG alarms may not operate properly when TENS stimulation is in use There should be a prominently placed statement warning that stimulus deliv ered by this device may be sufficient to cause electrocution Electrical current of this magnitude must not flow through the thorax because it may cause a cardiac arrhythmia 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 machinery 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 Federal law restricts this device to sale by or on the order of a physi cian Chapter 4 GENERAL DESCRIPTION The AGF 602 TE
17. table from 30 to 260 microseconds ELECTRODES LEADS 5 Modulation Mode Pulse width is automatically varied in cycle ELECTRODES pattern over an interval of nominally 6 5 seconds 1 Pulse width decreases linearly over a period of BELT CLIP 0 5 sec From the control setting value to a value which is 60 less 06 LEADCONNECTOR 2 This narrower pulse width is maintained for 2 seconds and then increased linearly over a log INTENSITYKNOB sd 0 5 second period to its original value o9 BN MSWITCH sd 3 Pulse width is maintained for 3 5 sec at the control setting value 4 The cycle is then repeated Bursts occur twice very second Pulse iddth adjustable frequency 100 Hz Chapter 8 ACCESSORIES Timer Timer Selectable 15 30 and 60 minutes 7 8 Wave Form Asymmetrical Bi Phasic Square Pulse Each set AGF 602 TENS are completed with standard accessories and standard 9 Voltage 0 to 34 V Load 500 ohm label as given below Max Charge per pulse 20 micro coulombs Burst Mode One 9 Volt Battery alkaline or nickel cadmium Accessories rechargable REF NO DESCRIPTION QTY Battery Life Approximately 50 hours at nominal settings AGF 101 40 X 40 mm Adhesive Electrodes 4 pieces 95 H x 65 W x 23 5 T mm AGF 111N Electrodes Leads 2 pieces 14 Weight 115 grams battery included 9 V Battery 1 piece Instruction Manual 1 piece Carrying Case 1 piece PDF created with FinePrint pdfFactory trial version http www
18. te 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 516 998 4600 Edition V1 1 Printed in February 2007 D PDF created with FinePrint pdfFactory trial version http www pdffactory com
19. urrent impulses per seconds Hz for both channels can be continually adjusted Unless otherwise instructed turn the pulse rate control to the 70 120 Hz range PULSE RATE Hz 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 instruc tions regarding the pulse width are given in therapy set the control to the sug gested 70 120 uS setting PULSE WIDTH uS 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 PDF created with FinePrint pdfFactory trial version http www pdffactory com 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
Download Pdf Manuals
Related Search