OK key - Harmony Medical
Contents
1. The Main Menu When the Menu Key is pressed the Main Menu appears if the cursor is on a channel that is not fH activated pius The Main Menu presents As all the options for operating your device Use the Up Down keys to scroll to desire option press the OK key to confirm Peps tes Single Mode p 4 Selecting this option allows 06 you to set any parameter for Om w any for a single channel 2 independently of those prus 12 256 192 chosen for the other three ts a0 20 20 With the cursor on the He o a 2 chosen channel it can be Pius 125 250 192 activated by selecting the tes oo 20 0 10 Start option Note no connecting bars between the channel numbers trj AN ane ane Paired Selecting this option will set the parameters for channels 1 and 2 a pair and those for channels 3 and 4 as a second pair In this mode the parameters set for either member of a pair of channels will automatically be copied to the other one except for the Timer duration and amplitude once the channels have fer Z Z5 been started The pulses from M B aun the two paired channels will be synchronised Syne Mode fom fa pus tes f rrr 208 06 ws w2. can be arranged with May Useful websites for information on EA studies or general information on TENS and electrotherapy oc of electrode placement Hor supply of medical devices accessories and general referenco oce ACP or the BASC Goethe BMAS or David Mayor
3. and 95 Do not drop or mishandle During transportation always secure the unit in its original case or in a protective container Care and Maintenance Maintenance of the stimulator is limited to periodically wiping clean the unit using a clean soft damp cloth wi mild soap solution or water Using other cleaning solutions may damage the unit DO NOT IMMERSE STIMULATOR IN ANY CLEANING SOLUTION The output leads should be wiped clean with a cloth dampened with mild soap solution and then wiped dry The unit can be used life long unless it develops a malfunction It does not have a limited shelf life or a restricted use by date To have your unit serviced or repaired contact an authorized dealer Trouble shooting 1 If an X sign flashes in the display on a channel accompanied by an audio sound beep the channel is automatically shut down This may indicate that the channel has been short circuited or a cable is disconnected or broken If the X sign appears please investigate the cause s of the problem before the channel is re activated Trouble shooting 2 When your unit does not respond to any action with your key pads and your screen freezes turn off the unit by switching off the power Remove all cables from your unit before turning it on again Check that the unit operates correctly before re connecting the cables Start your treatment again Trouble shooting 3 Check and repl
4. device is protected from damage if the battery is inserted incorrectly but the device may not function correctly Always check the polarity uos AC DC Adaptor Only use an AC DC adaptor which is supplied approved by the manufacturer The adoptor must suitable for medical devices with the Maximum output 10 VA Switch off your Classic 4 and disconnect any connected channel Switch off the power supply of your AC DC adaptor before connecting the plug into Classic 4 s ACIDC socket Turn on the power supply first before switching on your Classic 4 An adaptor is only supplied as an optional item A com Communication Port DONOT remove the protective cap from the Communication Port DONOT connect to the Communication Port In the current version of Classic 4 the Communication Port is used by the manufacturer for programming and diagnostic of the device and is not designed to be used by users The communication port will become available for users as add on devices and applications are developed Standards Classic 4 Stimulator complies with 93 42 EEC EN60601 1 2008 EN60601 1 2 2007 0120 Unit and Accessories Main treatment unit No MA304 Connecting cable to electrode 4pes Art No in four colour GBYB Alligator clips to 2 pin jacks electrode cords 4pes Art No MBI60A User s Manual CD MA3042 PP3 9 Volt
5. a device designed solely for TENS for EA Please refer to your prior training notes for details Ifin doubt do not eat in these circumstances and always lise with patient s medical practitioner consulant Parameters to use For low frequency acupuncture like stimulation ALS 2 10 Hz it is generally thought that amplitude should be strong but not painful For high frequency TENS like stimulation TLS 80 175 Hz stimulation should be definitely feel able but not uncomfortable There is some agreement in the literature that ALS is more appropriate for chronic pain and flaccid paralysis with TLS more often recommended for acute pain and spasticity However individuals vary in their response to electrical stimulation Sometimes it is a matter of trial and error to find which particular combination of parameters is most effective for a particular patient Adjusting the pulse duration may improve results in some circumstances as may the use of dense disperse stimulation altemating low and high frequencies or simultaneous application of different parameter combinations at different locations The Classic 4 gives much scope for exploring such variation For more details see the references below Where to position needles and Surface electrodes EA Points may be selected from local ashi or trigger and distal points huatuojiaji and auricular points and also from most of the points that you would normally use as an
6. acupuncturist for systemic or syndrome based treatment TENS Useful illustrations of electrode placements can be found at www harmonymedical co uk Note that TLS is more effective when used locally or in an area segmentally related to where the condition is focused but that ALS may be effective when applied elsewhere as well Features 1 Versatile electro therapy for treatment of a wide spectrum of TCM patterns or physical conditions The facility to use different output parameters within the same treatment session The ability to use concurrently as an electro acupuncture stimulator and a TENS EMS unit Features 2 3 Output Modes Single Paired Sync 4 Output Channels 24 pre set frequency settings 0 5 Hz 200 Hz 20mA capped can be raised to maximum of 60mA output current 28 pre set programmes 8 user defined programmes Unit Layout On Off switch Output channel sockets Communication port Screen Control keys Adaptor socket Bm Battery compartment Screen Layout 1 The screen of Classic 4 ME is divided into a table 00 epus with 5 columns and 11 f rows Mm mmm Bach entry in the Ist ts column shows what meis vm 192 parameters are used for tes oo 20 30 10 that row in the other four fee ANA columns of the table M B nun nt nnr The top
7. pl t1 will change to those of the second set of pulses 2 p2 12 Subsequently at the end of this second interval 12 the parameters will revert to those of the first set for the duration of t and so on Oset your own parameters 2 If 12 is set to zero the pulses will run continuously with the settings for the first set of pulses fl pl t1 To change any of these parameters position the cursor on the desired one and then press the OK key A small window will open and the value inside the window can be changed up or down by pressing the Up key or the Down key A quick press will change the value to the next one whereas keeping the button pressed will scan through the available values LE List of Presets 1 B rara xw p w m Dae pm iin iS oc es corma w E omo 0 me sec PPM IC p pomum Mant esi SIEGE a poo amp Ms mtl EE LED porem 37041 p m pm e p morcm denm nem poe List of Presets 2 ps p p p He a mig He He Hel pour sees 7 Load Presets 1 Select the channel s press the Menu key move the Up Down keys to select Preset This option will lead to a new screen opens as shown to the l
8. that additional cover can be provided for these as adjunctive therapy under your policy Safety Warning This equipment may be affected by electro magnetic interference Also the Classic 4 may affect other electrical equipment in the close vicinity If such effects are suspected either switch off the offending equipment or increase the distance between the affected equipment and that suspected of causing the interference The devise may be sensitive to static discharge to avoid risks or damage to the unit do connect to patient before turn on Intended ic 4 stimulator is intended to be used by sionals in the disciplines of Physiotherapy Acupuncture Sports Medicine or related The device is used for electrical stimulation in TENS EMS transcutaneous nerve and muscle electro stimulation or electro acupuncture protocol in conjunction with usage of electrodes or acupuncture needles There could be scope for its use by patients after having been instructed by their practitioner doctor who should be satisfied of the appropriateness of this decision Indications Indications for EA In general EA can be used for any condition for which acupuncture is indicated especially when manual stimulation has not brought a response or when stronger stimulation reduction is appropriate For example it has been used to reduce pain help repair nerve damage decrease inflammation retar
9. the amplitude oft Faulty chant shut down Channel is An Cell ised wi an Active Cell ew arn sig ee el You change the value in the cell by using the Up Down Control Keys EH Cursor Cell Ve mated Cal de cunc Select Output Channel The output sockets are located at the top of your unit When the unit is turned on the screen presents a table with 5 columns The left column lists all available parameters The remaining 4 columns with headings numbered 1 to 4 correspond to output channel sockets 1 to 4 When the cursor is within the chosen Channel column press the Menu Key to apply an option or to activate the output channel with the Start command Ld Activated Channel When the Start key is selected the activated channel s will be identified by small lightning icon next to the channel number s and the treatment time count will start counting down Each channel is capped at 20mA for safety operation in electroacupuncture To operate a channel beyond 20mA press the FN key when the intensity reaches 20mA the lightning icon is changed from hollow to solid TD Faulty Channel When the X sign appears next to a channel accompanied by a sound bleep this indicates that there is an error on the channel The output of that channel is automatically cut off Read the Trouble shooting section of this manual to rectify problem Menu
10. Clossic User s Manual English version 2 1 2009 10 Please read this document first before operate the unit Classic 4 Combination of Electro acupuncture TENS EMS Contents Safety Issues 4 13 Features 14 15 Layouts 16 18 Control Keys Cursor and Signs 19 24 Menus and Functions 25 41 Operating the Unit 42 49 Trouble shooting 50 52 Technical Data 53 61 Mam 62 65 Important Safety Instructions Do read this instruction manual first to ensure proper operation Do keep this manual in a safe place for future reference Do not drop this device and keep it away from water or other fluids Never use the Classic 4 when it is not functioning properly or when it is damaged Requirements Before using the Classic 4 with patients you should have received some training in EA and or TENS EMS know how to set up and use equipment correctly and feel competent in its use You should also have familiarised yourself with the Classic 4 and this instruction manual Your equipment should be thoroughly and regularly checked at least once each year to ensure it is performing correctly and if a device related adverse incident occurs you should report this immediately to HMD Europe Lid Finally ensure that the practice of EA and or TENS EMS is covered in your current malpractice and public products liability insurance policy If not you must check with your insurers
11. M B nun jrun nf nut Selecting this option will set channels 1 2 3 and 4 to run in synchrony In this mode the parameters set for channel 1 will be automatically be copied to the other three except for the Timer duration and amplitude once the channels have been started The pulses from the four channels will be synchronised Sync Mode is the factory pre set default Start 1p 2 a 4 Start to start the selected channel after locating the cursor on its column The activated channel s will be identified by a small lightning icon next to the channel number s and the treatment time count will start counting down Stop Stop Menu When the Menu Key is pressed and the cursor is on channel that is activated the Stop Stop All menu appears on screen Use the Up Down keys to scroll options and press the paps 256 250 ve OK ky to contra ee 00 os 80 to stop output to the selected channel fee AA stop Al to stop output to all aun nar nar active channels 225 155 00 oo Onn 18 10 10 o 10 paps ta x Reset parameters Reset Values when this option is highlighted and the OK key is pressed the parameters will be reset to the values previous installed for the selected Channel Parameters 1 Output current amplitude in mA Treatmen
12. ace battery if the screen does not turn on after the unit is switched on If the problem still cannot be resolved the unit should be returned for repair Do not attempt to repair the unit yourself but return it to your local authorized dealer or contact the manufacturer for repair or service Technical Specifications Frequencies in Hz Output modes 05 1 1 5 225 3 5 7 8 10 Constant Modulated Burst 15 18 20 25 30 40 50 60 30 Ranped and User defined 100 125 150 15 200 Programmes Pulse dation 0 64 128 192 2564s 50 Timer 11 7 in second Power 1x9V baneryleuemal 0 1 2 3 5 10 30 60 120 240 adaptor 600 900 Weight 260 grams Waveform including banery Biphasic symmetrical alternating Output channels 4 channels rectangula pulses charge Monophasi rectangular pulses Timer 5 90 minutes r I Battery Indicator The low battery indicator will begin to flash when the battery becomes low You may continue to use the unit for your current treatment session and replace the battery for your next session When the low battery indicator flashes with ONE bar showing please do not start your treatment session but replace with a new battery immediately a Battery Switch off the unit To change a battery push open the battery compartment at the back of the unit Remove the used battery from the battery compartment Insert a new battery according to the diagram The
13. d muscle atrophy relax or strengthen muscle in cases of paralysis improve microcirculation and tissue repair and aid relaxation and drug withdrawal Indications for TENS TENS is used for the symptomatic management of acute and non malignant chronic pain It has also been used for cancer pain in palliative care and for nausea Contra Indications Electro Stimulation Therapy TENS EMS or Electro Acupuncture should not be used by anyone with a cardiac pacemaker It should not be used in pregnancy or by people with serious disease unless it is part of an intended treatment protocol Contraindications to EA and TENS a brief checklist Undiagnosed pain Cancer Epilepsy Pregnaney Patient fitted with a pacemaker or other implanted electronic device All patients should be advised NOT to use TENS while driving operating hazardous equipment Where not to stimulate Over the front of the neck or the carotid sinus at the side of the neck So that current flows through the brain or heart Where there are skin conditions such as eczema Where there is abnormal skin or muscle sensation In this case electrodes or needles should be positioned elsewhere to ensure effective stimulation At contraindicated acupuncture points When using the Classic 4 for EA ensure that you do not apply currents of more than 20 mA and that you use the biphasic and not the M monophasic waveform Never attempt to use
14. dy to use Instruction for use with acupuncture needles Determine the Output mode for your Populate parameters for each channel you want to use Set the treatment timer for each output channel Connect output wires to needles electrodes Move cursor to highlight the channel you want to begin press Menu key use Up Down keys to highlight Start option press the OK key The channel is now active Active cell opens Use the Up Down keys to increase the intensity as appropriate pressing the OK key to lock the current intensity Repeat steps 5 to 6 for the other channels you wish to use The treatment timer counts down automatically once the channel is set to Start and turns the channel off at this point when it reaches zero An audio sound is also emitted Making adjustments during treatment D gt To adjust the current intensity go to that channel press the OK key so that the cell is Active use the Up Down keys to make your adjustment and confirm with OK key again increase decrease duration of the treatment session move the cursor to where the channel and treatment timer row meet press the OK key so that the cell is Aetive use the Up Down keys to ncrease decrease the timer setting and press the OK key again to confirm Each channel is capped at 20mA for safety in electroacupuncture to increase beyond 20mA press the FN key and use the Up key to increase and confirm with OK key again For saf
15. eft Use the Up Down keys to scroll through the list of presets The preset parameters are shown in the right column Press the OK key on the desired set This will load the relevant parameters and copy them over into your selected channel s in the left column Load Your Favourite 1 Select the channel where you want your favourite to be loaded 2 Press the Menu key move the Load Up Down keys to select Load A new window opens as shown in the left 3 Use Up Down keys to flick through your saved favourite as in User P1 to P8 click OK key to confirm 4 The left column shows values of yeurexisting channel the right column shows the stored values El Save Your Favourite 1 This option will lead to second screen as shown on the left Eight User slots are available Use the Up Down keys to select which slot you want to save your parameters Existing parameters in the slot will be over written with your new values 3 The values saved are taken from the single chosen channel only Starting the Treatment Preparation Prepare your patient for treatment keep your patient calm and relaxed Switch ON the Classic 4 stimulator Check that the sereen lights up showing all channels and the low battery indicator is not on Switch OFF the Classic 4 Insert output cables in channel sockets Connect output cable s to your patient Turn ON the Classic 4 again The unit is rea
16. ety and the patient s comfort in both Sync and Paired Output modes only the output current intensity and treatment timer are adjustable during a treatment session without resetting the channel In the more advanced Single Output mode you can make adjustments to all parameters However there will be a timed delay before these changes take place Stop and Resume Treatment To stop or pause a channel or pair of channels move your cursor to the channel you wish to pause Or stop press the Menu key to open the Stop sub menu select Stop to stop the highlight channel or Stop channels This sets the current of selected channel gently to zero and the treatment timer is set to pause To resume treatment press the Menu key select Start and adjust the output current again Treatment Completed When a treatment session is completed turn off the power Disconnect cables from acupuncture needles or electrodes Then remove plugs from output sockets After Treatment Replace battery if the Low Battery sign appears during a treatment session Remove the battery from the battery compartment if the unit is not required for more than a few days Remove the AC DC adaptor if an external adaptor has been used Storage and Transportation Store unit in a dry location free from dust and contamination where the temperature remains constant and within the range of 16 C to 40 C 61 F to 104 F humidity between 15
17. on of Conformity HMD Europe Limited declares that the medical device describes Classic 4 has been classified as Class and is in conformity with the essential requirements and provisions of Council Directive 93 42 BEC and in conformity with the national standard transposing harmonised standard EN60601 1 2008 EN60601 1 2 2007 and is subject to the procedures set out in Annex V of Directive 93 42 EEC under the supervision of Notified Body Number 0120 SGS United Kingdom Ltd London 6 October 2009 P Choy tata of HMD Bape nied C o120 Manufacturer H D HMD Europe Ltd 629 High Road Leytonstone London E11 4PA UK Tel 44 0 20 8558 8205 http www hmd europe com Please record this information and keep this User s Manual in a safe place for future reference Serial No located on the back of the device Date Purchased Dealer Stamp Resources The following books provide further information MI 200 Transcuaneus cic sene imn TENS In Wanan TE Either Evidence sd 252290 Mayar DE BL 2007 Eimacipanctre A practical anal and ce Edhar Church Livingstone in tee of A or TENS cont your own Ifyou are an concu practioner ia le UK e Acupuncture Association of Chanered Payers AACP and Medical Acupuncture Soy BAS run coumes For Bish Coun BACC members ore lied
18. row shows the number of channel Screen Layout 2 Number of output channel Electrical parameters Low Battery Indicator Working area Pop up menu Control Keys 1 Key Cancel actin selection go back previous Mens Key Choose Trom a Tis factions The main Menu includes options selection of output Modes Load and Save programmes and Reset OK key To CONFIRM and accepi selected changed aloe Up Key Pres to move the cursor Up or Cii INCREASE vale inside and Active Cel Note keep this key pressed fr rapid increase Down Key Press to mave the cursor Down ar Click ur DECREASE value inside and Active C Noue keep this key pressed for rapid increase Control Keys 2 Tlf Key Move LEFT ta previous channel Bom cron sor position Tight Key Move RIGHT io neu channel fom cua gt position TN Key Function key be wed in combination wi G iler Keys for rapid action COM Key Com key can wed in comin with her Conil Keys for external communication and e applications Note The function of this key is currently under development and i not available to the user at this Channel and Cursor Active for mesmen use When an active channel s operated Active iari te ico is High Current from hollow ia a solid symbol When Cham Fay ign irme ON
19. s battery 1 MB902 Optional Accessories Carrying Case Art No MB1084 ACIDC adaptor Art No MB1086 Grip type connector to 2mm Art No MB120 Explanation of Symbols CE mark of conformi The device confirms with the Essential Requirements for Medical Devices Directive 93 42 EEC as supervised SGS United Kingdom Limited Notified Body Number 0120 The manufacturer ofthe medical device tention Consult accompanying documents TYPE BF APPLIED PART The device is manufactured in the year shown next tothe Symbol rd gt gt Contains electronic parts subject to local national disposal recycle requirements Speciation Tar degrees of proiection provided by enclosures UP cals ta EN 60529 Warranty Classic 4 electrical stimulator is warranted to the initial purchaser against any defects in material and workmanship for a period of twelve months from the date of purchase If the stimulator is found to be defective within the warranty period it will be repaired or replaced if returned prepaid to an authorized dealer This warranty does not cover damage caused by rental misuse negligence accidents and abuse or alteration or modification of the unit No liability is held in either tort or contract for any loss or damage direct consequential or incidental arising out of the use misuse or inability to use this product Declarati
20. t duration timer 0 90 minutes Repetition frequency of 1 set of pulses Width of 1 set of pulses in microseconds Burst duration for 1 set of pulses in seconds Parameters 2 f Repetition frequency of 2 set of 2 Hz pulses Width of 2 set of pulses in HE microseconds t Burst duration for 2nd set of pulses in seconds f f The types of change from 1 pulses to 1 12 pulses Ramped or Step M B Waveform symmetrical biphasic or monophasic Set the Parameters The Classic 4 is a versatile and powerful stimulator You set the frequency pulse waveform pulse duration and timing of each set of pulses and channel according to your clinical needs You can fine tune and modify your settings rapidly in various ways The basic methods Load preset parameters Load saved parameters Set your own parameters set your own parameters 1 The parameters f1 frequency 1 pl pulse width 1 and 11 duration of on time 1 refer to an interval of duration t1 during which pulses are emitted at a repetition frequency fl and with a pulse width pl The parameters f2 frequency 2 p2 pulse width 1 and 2 duration of on time 2 refer to an interval of duration 12 during which pulses are issued at a repetition frequency f2 and with a pulse width p2 At the end of time t1 the characteristics of the pulses 1
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