Tens Machine UK: Pain Relief Devices & Electrical Stimulation
User Manual for Tens Machine UK models including: EM6300A, 2460, EM6300A Premier Tens and Ems, EM6300A, Premier Tens and Ems, Tens and Ems, and Ems, Ems
Premier Pro TENS and Muscle Stimulator | Effective Pain Relief
Nov 19, 2024 — This manual is valid for the Med-Fit TENS and Muscle Sitmulation Devices. This user manual is published by Med-Fit UK Ltd. Med-Fit UK Ltd reserves the right ...
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DocumentDocumentMed-Fit Premier TENS & EMS Pain Relief - TENS Machine - Muscle Stimulation. Alivio del dolor - Máquina TENS - Estimulación muscular. Schmerzlinderung - TENS Machine - Muskelstimulation. Soulagement de la douleur - Machine TENS - Stimulation musculaire. EM6300A 2460 med fit Patient Instructions & User Manual Instrucciones para el paciente y manual del usuario Patientenanweisungen & Benutzerhandbuch Instructions pour le patient et manuel d'utilisation Tel: 0161 429 7330 email sales@med-fit.co.uk Contents WHAT'S IN THE BOX ........................................................ 3 CONTROLS AND FUNCTIONS .......................................... 4 STEP BY STEP GUIDE .....................................................5 CHARGING INSTRUCTIONS ............................................7 WARNINGS AND CAUTIONS ............................................8 MALFUNCTIONS ..............................................................8 SAFETY-TECHNICAL CONTROLS ..................................... 9 CONFORMITY TO SAFETY STANDARDS ....................... 10 TENS PROGRAMMES P1 - P12 .....................................11 MANUAL ADJUSTMENTS FOR TENS ............................. 13 MANUAL ADJUSTMENTS FOR EMS............................... 16 HELPFUL TIPS ..............................................................19 EMS & MASSAGE PROGRAMMES P13 - P24 ................ 20 TECHNICAL SPECIFICATION .........................................21 EMC INFORMATION ......................................................94 Skin Patch Test It is recommended that you carry out a patch test before applying your first treatment, To do this, remove one electrode from the packaging and place on a part of your body which is both visible and easy to inspect. After 30 minutes, remove the electrode and inspect the area for any redness or irritations. If no change is noticed, proceed with your first TENS treatment following the User Guide and Instructions provided. If skin irritation has been noticed, we recommended the use of sensitive gel electrodes. 2 What's in the box? 1 2 3 MODE SET 4 5 6 1. TENS unit 2. USB charging lead 3. User manual 4. AC adaptor. 5. Patient leads. 6. 16 5x5 self-adhesive electrodes. 3 Controls and Functions 1 2 15 3 10 4 5 6 11 7 8 12 9 13 14 1. Left channel socket. 2. Right channel socket. 3. Red key lock button. - Pressing the Red Key Lock Button locks all parameters including the intensity level. This is ideal once you have set the device which removes accidental movement of the setting. 4. Mode display. 5. Mode select button to change from TENS to EMS. 6. Intensity up channel 1. 7. The set button is to select the desire parameters in manual mode only it has no function when using the pre-set programmes. 8. Intensity down channel 1. 9. On / Off Pause Button. - When your device is on you can pause the treatment by pressing and holding down the on-off button for approximately 2 seconds. 10. Charging port. 11. Intensity up channel 2. 12. Intensity down channel 2. 13. Programme selector up and down. 14. LED charging indicator. 15. Low Battery Indicator - When the battery level reaches 10% capacity a battery symbol will appear on the screen indicating a charge will be required. 4 Step by Step Guide Step 1 Before using your premier TENS for the first time, please fully charge the battery see page 7. Step 2 Press the button to switch on the TENS. This is located at the bottom left hand corner of the TENS device. Please push and hold down the button for 2 seconds to turn the unit on. Step 3 Pressing the MODE button will allow you to change from TENS to EMS Mode (we always recommend to start with a TENS programme P1 - P12). Step 4 To change the programmes please use the arrow keys directly below the set button this will allow you to choose the required programme. Step 5 Please refer to the programme charts supplied in this guide for details on each programme available, please remember that P1-P12 are TENS programmes and P13-P24 are EMS programmes. Step 6 The recommended programme to use for a first time TENS treatment is programme P1. This is a gentle TENS treatment with a good pain blocking effect and is an introduction to TENS stimulation. Step 7 You are now ready to use the TENS for the first time. (see step 8). 5 Step by Step Guide Step 8 Connect one of the TENS lead cables supplied to the top of your TENS machine. As shown in Fig1. Now connect the other end of the TENS cable to the self-adhesive electrodes supplied. As shown in Fig2. Next place the self-adhesive electrodes on to the painful site or as recommended by your healthcare professional. You are now ready to turn up the intensity on your TENS machine. Step 9 The intensity keys on your TENS are marked CH1 and CH2. To increase the intensity press the up arrow key, each press increases the intensity by 1mA and is displayed in the screen. It is recommended that you increase the intensity to a sensation which is comfortable and not too strong. As you use the TENS for longer periods it may be necessary to increase the intensity to higher levels. To control your pain more effectively. It is recommended CH1 the first treatment should be a minimum CH2 of 1 hour to 2 hours to give the best MODE possible results. SET < < 6 Charging Instructions Important information The USB charging cable connects to TENS charging port as shown in fig 1 (Please ensure you connect the cable the right way round) Charging your TENS device. Connect the USB cable to the AC adaptor or USB port as shown in figure 1. Now connect the USB cable directly into the USB socket, which is located on the right hand side of your Premier TENS. A red indicating light will be seen in the bottom right hand corner of your TENS device. We recommend you charge the device for approximately 2 hours. Once fully charged the unit will be ready for use and the LED charging light will turn to green, this indicates the unit is fully charged. Remove the USB charging lead from your TENS device and disconnect from the mains supply or USB port. Please store your adaptor and cable in the carry case provided when not in use. Make sure the the connectors face up see fig 1 Place the small USB connector in the charging port. The charging light will turn red. Place the plug over the connectors see fig 2 Fit the plug to the other USB connector Slide down until it clicks into place see fig 3 7 Warnings and Precautions Please Note: It is imperative that patients read and understand the warnings and precautions before using this device. Do not allow your machine or electrodes to be used by anyone else, as they are designed for single patient use only. It is recommended that proper medical advice on the use of TENS is sought from a Qualified Practitioner (Physiotherapist, Doctor or Nurse) prior to use, in order to ensure safe and effective treatment. If you are taking any medication please carry on as normal but seek advice from your Doctor/Healthcare Professional before using the device. WARNING! PATIENTS WITH PACEMAKERS MAY NOT BE TREATED WITH TENS · Do Not use during pregnancy except during labour (under medical supervision). · Do Not place electrodes over the Carotid Sinus. · Do Not use on broken or damaged skin. · Do Not place electrodes close to the eyes or in the mouth. · Do Not use TENS while driving or operating machinery. TENS is unsuitable and should not be used in the following situations: · Persons suffering from conditions where the circulation is impaired. · Epilepsy, Heart Condition or any form of Malignancy. · Patients with poor skin sensation and non-compliant patients who are emotionally disturbed or have dementia. · Over metal implants or in conjunction with sleep apnea or heart monitors. You should be aware that TENS units provide symptomatic relief only and are not considered curative. Malfunctions Should any malfunctions occur while using the EM6300A Digital TENS/EMS, check - check the cable is correctly connected to the device. The cables should be inserted completely into the sockets. 8 Warnings 1. The long term effects of chronic electrical stimulation are unknown. 2. Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex. 3. Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing. 4. Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmias. 5. Stimulation should not be applied transcerebrally. 6. Stimulation should not be applied over swollen, infected, inflamed areas or skin eruptions. 7. Stimulation should not be applied over or in proximity to cancerous lesions. Contraindication: Electrical stimulators should not be used on patients with cardiac demand pacemakers. Adverse Reactions: On rare occasions skin irritation and burns beneath the electrodes have been reported with the use of electrical stimulators. If irritation occurs, discontinue use and consult your Healthcare Professional. Safety-Technical Controls For safety reasons, review the following checklist before using your EM6300A Digital TENS/EMS: 1. Check the device for external damage. - deformation of the housing. - damaged or defective output sockets. 3. Check the usability of accessories. - patient cable undamaged - electrodes undamaged. Please consult your distributor if there are any problems with the device and accessories. 9 Cautions 1. Safety of powered muscle stimulators for use during pregnancy has not been established. 2. Caution should be used for patients with suspected or diagnosed heart problems. 3. Caution should be used in the presence of the following: a. When there is a tendency to haemorrhage following acute trauma or fracture; b. Following recent surgical procedures when muscle contraction may disrupt the healing process; c. Over the menstruating or pregnant uterus; and d. Over areas of the skin which lack normal sensation. 4. Some patients may experience skin irritation or hypersensitivity due to electrical stimulation or electrical conductive medium. Using an alternate conductive medium, or alternate electrode placement can usually reduce the irritation. 5. Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner. 6. Powered muscle stimulators should be kept out of the reach of children. 7. Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer. 8. Portable powered muscle stimulators should not be used while driving, operating machinery. Conformity to Safety Standards The EM6300A Digital TENS/EMS devices are in compliance with the following standards: EN 60601-1-2: 2007 Medical electrical equipment. - Part 1-2: General requirements for basic safety and essential performance. - Collateral standard: Electromagnetic compatibility. - Requirements and tests. EN 60601-1:2006 Medical electrical equipment. Part 1: General requirements for basic safety and essential performance. 10 TENS Programmes P1-P12 - 12 Clinically validated TENS programmes for drug-free pain relief. All programmes run on a continuous time indicated by the letter [C] on your display. Programme 1 Conventional TENS Ideal for your first TENS treatment, for both acute, chronic and long-term use. Suitable Conditions: Neck Pain - Shoulder Pain - Knee Pain - Lower Back Pain - Sciatica - Arthritic Pain. Programme 2 Sciatica - Pain Relief Effective pain relief for irradiation of pain along the path of the sciatic nerve. Recommended treatment time 2 + hours or until pain alleviates. Programme 3 Lower back Pain Programme 3 is most effective for lower back pain and increased blood circulation. This programme alleviates the pain by stimulating muscles to release the body's own morphine-like substances Recommended treatment time 90 minutes or until the pain subsides. Programme 4 Knee Pain This programme is ideal for treating knee injuries both acute and chronic including osteoarthritis rheumatoid arthritis and joint pain. Programme 5 Shoulder Pain Treating shoulder pain relief from heavy or repetitive lifting, arthritis, and tendinopathy. Programme 6 Muscle Pain This programme is pre-set for all types of muscle pain relief ideal for muscle tension in the neck, shoulder and lower back (lumbar spasms). 11 TENS Programmes Programme 7 Migraine/Headaches Reduced pulse width ideal for treating nerve rich areas. Suitable Conditions: Tension Type Headache, Facial Pain, Neck Pain, Postherpetic Neuralgia. Programme 8 Cervical (Neck) Pain Cervical pain relief due to poor ergonomic work positions. Programme 9 Epicondylitis - (Elbow) Pain relief for epicondylitis resulting from repetitive gripping of objects. Programme 10 Foot & Ankle Pain This programme is most suited for foot and ankle pain and increases circulation. Programme 11 Arthritic Pain This programme is ideal for arthritic pain as it can be used for long periods of time with little or no accommodation which offers superior pain relief on most areas of the body. Programme 12 Joint Pain & Fracture Pain This programme is ideal for all common areas of joint pain, with this treatment we recommend that the stimulation is increased to a stronger level than the pain itself. 12 Manual Adjustment for TENS 1. Power On/Off/Pause Button The power of unit can be turned on by pressing the On/Off/Pause button. You may start to adjust the settings when the liquid crystal display is on. Press and hold for 2 seconds to switch off. To pause stimulation press the button once. To resume stimulation press the button again and stimulation will be restored in 2 seconds. 00 TENS TENS B B 60Min 60 Min If the unit is not used (buttons not pressed or output level at 0) for 5 minutes, the power will be shut off automatically. 2. Mode Control MODE There are 5 TENS modes(B, N, M, S1, S2) and 3 EMS modes (C, S, A) available. The mode is selected by pressing the "Mode" control. When a TENS mode is selected, the LCD shows "TENS". When EMS mode is selected, the LCD shows "EMS" 00 TENS B 60Min 3. Set Control SET By pressing the "Set" control you select the setting you intend to adjust. The value is set by pressing the "Increment" or "Decrement" controls when the "Set" value is flashing. 4. Increment Control This button controls the increase of settings. 5. Decrement Control This button controls the decrease of settings. 13 Manual Adjustment for TENS 6. Intensity Increase Control There are 99 steps of intensity adjustment control. Press the button until the desired intensity level is reached. 7. Intensity Decrease Control There are 99 steps of intensity adjustment control. Press the button until the desired intensity level is reached. 8. Key Lock Facility Pressing the "Lock" buttons prevents the settings being changed but the output may be stopped by pressing the "On/Off/Pause". Key Lock 9. Steps to Set a TENS Program The settings can be adjusted according to the following steps. a. Turn on the Power b. Select a Mode Select a mode by pressing the "Mode" control. The mode you selected will show up on the top of liquid crystal display. There are 5 modes of your option including - B(Burst), M(Normal), M(Modulation), S1, S2 and P. When a TENS mode is selected, it shows "TENS" on the liquid crystal display. After a mode is selected, always press "Set" to enter next setting, and press " " or " " to adjust its value. c. Set Pulse Width Pulse Width is adjustable from 50 s to 300 s. Press "SET" control to enter this menu, then press " " or " " to adjust the setting. If no instructions regarding the pulse width are given in therapy, set the control to the suggested 70- 120 s setting. 00 TENS Width B 300 14 Manual Adjustment for TENS d. Set Pulse Rate Pulse rate is adjustable from 2Hz to 150 Hz . Press "SET" control to enter this menu, then press " " or " " to adjust the setting. Unless otherwise instructed, set the pulse rate l to the 70-120 Hz range. 00 TENS Rate B 50 e. Set Timer The treatment time is adjustable between 5 - 60 minutes and Continue(C). Press "SET" control to enter this menu, then press " " or " " to adjust the setting. The liquid crystal will show the balance treatment time after the stimulation is started. Output will be terminated when time is up. Turn off the unit when the output is off. 0 00 TENS TENS B B 60Min 00 0 TENS B C 0 Min f. Adjust Intensity There are 99 steps within the intensity range. Set the desired level by pressing the " " or " "Lock" button to prevent accidental changes. " controls. Press the 80 80 TENS B 60Min 15 Manual Adjustment for EMS 10. Steps to Set a EMS Program The settings can be adjusted according to the following steps. a. Turn on the Power b. Select a Mode Select a mode by pressing the "Mode" control. The mode you selected will show up on the top of liquid crystal display. There are 3 modes of your option including - C(Constant), S(Synchronous), A(Alternate). When an EMS mode is selected, it shows "EMS" on the liquid crystal display. After a mode is selected, always press "Set" to enter next setting, and press " " or " " to adjust its value. The settings will be stored immediately after selected. c. Set Ramp Time The ramp time controls the time taken to reach maximum and the time taken to fall to zero I order to make the contraction more comfortable. The ramp time is adjustable between 1 - 8 seconds. 00 EMS Ramp S8 S d. Set On Time The On Time controls the length of stimulation. By pressing the "Set" control, the contraction time can be adjusted. Both channels' stimulation is cycled on and off by the contraction and relaxation settings. The range is adjustable from 2 seconds to 90 seconds.The total "ON" time must be at least twice the "Ramp" time. 00 EMS ON S 30 S 16 Manual Adjustment for EMS e. Set Off Time The Off Time controls the length of relaxation. By pressing the "SET" control, the relaxation time can be adjusted. Both channels' stimulation is cycled on and off by the contraction and relaxation settings. The range is adjustable from 2 seconds to 90 seconds. In Alternate mode, the OFF Time should be equal or more than the ON Time. (OFF TIME ON TIME). 00 EMS OFF S 10 S f. Set Pulse Width Pulse Width is adjustable from 50 s to 300 s. Press "SET" control to enter this menu, then press " " or " " to adjust the setting. If no instructions regarding the pulse width are given in therapy, set the control to the suggested 70- 120 s setting. 00 EMS Width S 300 µs g. Set Pulse Width Pulse rate is adjustable from 2Hz to 150 Hz . Press "SET" control to enter this menu, then press " " or " " to adjust the setting. Unless otherwise instructed, set the pulse rate to the 70-120 Hz range. 00 EMS Rate S 150Hz 17 Manual Adjustment for EMS h. Set Timer The treatment time is adjustable between 5 - 60 minutes and Continue(C). Press "SET" control to enter this menu, then press " " or " " to adjust the setting. The liquid crystal will show the balance treatment time after the stimulation is started. Output will be terminated when time is up. Turn off the unit when the output is off. 00 EMS EMS EMS C S A 20Min 20 Min 20 Min i. Adjust Intensity There are 99 steps within the intensity range. Set the desired level by pressing the " " or " "Lock" button to prevent accidental changes. " controls. Press the 80 80 EMS S 60Min 18 Helpful Tips Once you have familiarised yourself with the controls and features of your TENS device, it is important to place the TENS electrodes in a position which gives the most pain relief. This may take 3 or 4 attempts to find the most suitable position, for maximum pain relief. If you are using two electrodes, place the electrodes directly onto the painful area at a position where you feel the pain starts and where it finishes. You may now position the electrodes around the painful area to locate the most suitable position for maximum pain relief. The alternative method is to use four electrodes surrounding the painful area see examples. The complete area between the electrodes will now be treated when positioning the electrodes as shown. Examples of Electrode Placement Here are three examples of electrode placement for knee pain. For best results, we recommend you try all variations as shown. TENS using one channel vertical pad placement. TENS using one Red squares channel horizontal pad represents placement placement. of electrode channel 1 blue channel 2. 19 EMS Programmes These 12 individual electronic muscle stimulator (E.M.S) programmes P11 - P24 have been clinically proven for the treatment of: 1. Muscle Re-Education 2. Muscle Training 3. Muscle Strengthening 4. Muscle Toning & Massage Please refer to the electrode placement charts provided for electrode placement guidelines. Deltoid Biceps Brachioradialis Quadriceps femoris Pectoralis major Trapezius Triceps brachial External oblique Rectus abdominis Buttock Adductor muscles Inside and outside gemellus Deltoid Thigh biceps Programmes P13, P16 Muscle Training & Muscle Re-Education Programmes These programmes can be used for muscle training, prevention of muscle atrophy. Programmes P17, P20 Muscle Strengthening & Muscle Re-Education Programmes These programmes can be used for building stamina and strength. Muscle re-eduction. Programmes P21-P24 Muscle Toning & Massage Programmes This programme stimulates the muscles with comfortable sensations which helps to tone and decrease any muscular tension. 20 Technical Specification Graphic Symbols: Degree of Electrical Protection BF Timer Increment Decrement Consult instructions for use Manufacturer Serial number Lock Low battery Pause DC current (DC Power source) Comply with MDD 93/42/EEC requirement as amended by 2007/47/EC. Notified body det norske veritas (DNV) Power The label attached to the back of the device contains important information about this device model, supply voltage, CE number, and caution. Please do not remove it. 21 Technical Specification TENS Programmes specification P1 - P12: No Programme Frequency Pulse Width 1. Conventional TENS 80Hz Ideal for first applications of TENS 180s 2. Burst TENS 2Hz Most effective for radiating pain 180s 3. Modulated TENS 80Hz Pain relief with a massage effect 70-180s 4. Mixed Frequency TENS 15Hz 180s 5. Fixed Frequency TENS 80/2Hz 180s Effective for long term use with reduced accommodation 6. Constant TENS Ideal for muscle pain 10Hz 180s 7. Modulated TENS 80Hz 60s Reduced pulse width ideal for treating nerve rich areas 8. Modulated TENS 10Hz 200s 9. Burst TENS 50Hz 90% Rate Modulation over 10 seconds 10 Mixed Frequency TENS 5-125Hz 250s 120s 11 Mixed Frequency TENS 2-100Hz Modulation Rate & width over 6 seconds 12. Modulated TENS Modulation Rate over 6 seconds 80<->7Hz 260-150s 260s 22 Technical Specification EMS Programmes specification P13 - P24: No Programme Rate Width Ramp SYN/ALT On Time Off Time Timer 13 ACL repair/joint protection back muscle SYNCHRONOUS 35 Hz 300 s 3 sec 8 sec 24 sec 20 min 14 Spasm small muscle 80 Hz 300 s 3 sec SYNCHRONOUS 10 sec 5 sec 20 min 15 Spasm Postoperative 80 Hz 250 s 2 sec SYNCHRONOUS 8 sec 4 sec 20 min 16 Arthroscope 25 Hz 200 s 2 sec SYNCHRONOUS 6 sec 30 sec 15 min 17 Disuse atrophy 35 Hz 300 s 2 sec 18 Shoulder Subluxation 50 Hz 300 s 5 sec SYNCHRONOUS 5 sec 15 sec 30 min SYNCHRONOUS 15 sec 50 sec 15 min 19 Range of motion 40 Hz 250 s 3 sec SYNCHRONOUS 6 sec 21 sec 30 min 20 Muscle training / re-eduction SYNCHRONOUS 50 Hz 250 s 2 sec 10 sec 10 sec 20 min 21 Muscle training / re-eduction SYNCHRONOUS 50 Hz 250 s 2 sec 14 sec 14 sec 20 min 22 Muscle training / re-eduction SYNCHRONOUS 35 Hz 400 s 2 sec 10 sec 10 sec 20 min 23 Muscle training / re-eduction ALTERNATE 50 Hz 250 s 2 sec 10 sec 10 sec 20 min 24 Muscle training / re-eduction ALTERNATE 50 Hz 250 s 2 sec 14 sec 14 sec 20 min 23 Technical Specification The Technical Specification Details of EM6300A are as follows: MECHANISM TECHNICAL DESCRIPTION 1. Channel Dual, isolated between channels. 2. Pulse Amplitude Adjustable, 0-100 mA peak into 500 ohm load each channel. 3. Wave Form Asymmetrical Bi-Phasic Square Pulse. 4. Voltage 0 to 50V (Load: 500 ohm). 5. Power source Lithium Battery. 6. Size 11.8cm(L) x 6cm(W) x 3.1cm(H). 7. Weight 150 grams with battery. 8. Timer 60 minutes or Continuous. Treatment time countdown automatically. 9. Low Battery Indicator A low battery indicator will show up when the battery is low. 10 Operating Condition Temperature:10°~40°C Relative Humidity: 30%~75%. Atmosphere Pressure : 700Hpa~1013Hpa. 11 Remark There may be up to a +/-5% tolerance of all parameters and +/-20% tolerance of output amplitude & voltage. 24 EMC Information This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment. 1)* Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit. 2) Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation! 3) * Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used 4) Warning: The use of ACCESSORIES, transducers and cables other than those specified, with the exception of transducers and cables sold by the MANUFACTURER of the DEVICE as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM. Guidance and manufacture's declaration electromagnetic emission The DEVICE is intended for use in the electromagnetic environment specified below. The customer of the user of the DEVICE should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The DEVICE use RF energy only for its internal function.Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emission CISPR 11 Class B The DEVICE is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations Complies /flicker emissions IEC 61000-3-3 Guidance and manufacture's declaration electromagnetic immunity The DEVICE is intended for use in the electromagnetic environment specified below. The customer or the user of DEVICE should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast ±2 kV for power ±2kV for power transient/burst supply lines supply lines IEC 61000-4-4 Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ± 1 kV line(s) to line(s) ±1 kV differential Mains power quality should be mode that of a typical commercial or hospital environment. Voltage dips, short interruptions <5% UT <5% UT (>95% dip in UT) (>95% dip in UT) for 0.5 cycle for 0.5 cycle and voltage variations on 40% UT 40% UT power supply (60% dip in UT) (60% dip in UT) input lines for 5 cycles for 5 cycles IEC 61000-4-11 70% UT (30% dip in UT) for 25 cycles 70% UT (30% dip in UT) for 25 cycles for 5 sec for 5 sec Mains power quality should be that of a typical commercial or hospital environment. If the user of the DEVICE requires continued operation during power mains interruptions, it is recommended that the DEVICE be powered from an uninterruptable power supply or a battery. <5% UT <5% UT (>95% dip in UT) (>95% dip in UT) for 0.5 cycle for 0.5 cycle for 5 sec for 5 sec Power frequency (50Hz/60Hz) magnetic field 61000-4-8 3A/m 3A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital IEC environment. NOTE: UT is the a.c. mains voltage prior to application of the test level. 94 EMC Information Guidance and manufacture's declaration electromagnetic immunity The DEVICE is intended for use in the electromagnetic environment specified below. The customer or the user of DEVICE should assure that it is used in such an environment. Immunity test IEC 60601 Compliance test level level Electromagnetic environment - guidance Conducted RF 3 Vrms 3 Vrms IEC 150 kHz to 61000-4-6 80 MHz Radiated RF IEC 61000-4-3 3 V/m 3 V/m 80 MHz to 2.5 GHz Portable and mobile RF communications equipment should be used no closer to any part of the DEVICE, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 80 MHz to 800 MHz 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DEVICE is used exceeds the applicable RF compliance level above, the DEVICE should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the DEVICE. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and the DEVICE . The DEVICE is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the DEVICE can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DEVICE as recommended below, according to the maximum output power of the communications equipment. Rated maximum Separation distance according to frequency of transmitter output power of (m) transmitter (W) 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz 0.01 0.1 1 10 100 0.117 0.369 1.167 3.689 11.667 0.117 0.369 1.167 3.689 11.667 0.233 0.738 2.333 7.379 23.333 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 95 Med-Fit UK Ltd. Unit 8 Martel Court, S. Park Business Park, Hamilton Road, Stockport, SK1 2AF Tel: 0161 429 7330 | Tel: 0161 429 7330 | Fax: 0161 427 0215 Email: sales@med-fit.co.uk | www.tensmachineuk.com Company registration number 08758741 | Vat registration number 308286105 This manual is valid for the Med-Fit TENS and Muscle Sitmulation Devices. This user manual is published by Med-Fit UK Ltd. Med-Fit UK Ltd reserves the right to improve and amend it at any time without prior notice. Amendments will however be published in a new edition of this manual.