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Roundwhale Med-Fit 3 TENS Instruction Manual

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INSTRUCTION MANUAL
Med-Fit 3 TENS
R-C101I
Shenzhen Roundwhale Technology Co.,Ltd.
202,2/F,Building 27,Dafa Industrial Park,
Longxi Community,Longgang District,Shenzhen,China
Be sure to read this instruction manual before operation
This user manual is published by Shenzhen Roundwhale Technology Co., Ltd

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  • Page 1 INSTRUCTION MANUAL Med-Fit 3 TENS R-C101I Shenzhen Roundwhale Technology Co.,Ltd. 202,2/F,Building 27,Dafa Industrial Park, Longxi Community,Longgang District,Shenzhen,China Be sure to read this instruction manual before operation This user manual is published by Shenzhen Roundwhale Technology Co., Ltd...
  • Page 2 1 FOREWORD 1.1 Introduction The Med-Fit 3 TENS Device is classified as an electrical stimulation system with one primary function: TENS therapy. Functionality of the Med-Fit 3: The device features 5 modes (Burst, Normal, Modulation, Strength Duration 1, and Strength Duration 2) as well as 7 pre-set programs.
  • Page 3 1.2.1 About Pain Pain is an important warning signal in the human body. It alerts us when something is wrong; without it, abnormal conditions can go unnoticed, potentially causing damage or injury to vital parts of our bodies. While pain serves a necessary role in diagnosing trauma or dysfunction, persistent pain can sometimes be counterproductive and serve little purpose.

  • Page 4: Safety Information

    2 SAFETY INFORMATION 2.1 Intended use Intended purpose The device is designed to be used for temporary relief of pain, including the acute and chronic pain relief. Target population The device using the object (patient) must be 18 years or older. Intended user Medical staff...
  • Page 5 SAFETY SYMBOLS IN THIS MANUAL 2.2.1 Contraindication 1) Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death. 2) The device should not be used when cancerous lesions or other lesions are present in the treatment area.
  • Page 6 2.2.2 Warning 1) Consult your physician before use if you have received medical or physical treatment for your pain. 2) Discontinue use and consult your physician if your pain persists for more than five days, worsens beyond mild discomfort, or fails to subside. 3) Avoid applying stimulation to your neck, as it may cause severe muscle spasms, airway obstruction, breathing difficulties, or adverse effects on heart rhythm or blood pressure.
  • Page 7 15) Avoid using the device on the eyes, head, or face. 16) Do not apply stimulation near the genitals. 17) Avoid using the device on areas of the skin with reduced or absent sensation. 18) Ensure electrodes remain separate during use, as contact between them may cause improper stimulation or skin burns.
  • Page 8 9) Use caution if you have an increased risk of internal bleeding, such as after an injury or fracture. 10) Consult your physician before using the device following a recent surgical procedure, as stimulation may interfere with the healing process. 11) Use caution if applying stimulation over the uterus during menstruation or pregnancy.

  • Page 9: Getting To Know Your Device

    2.2.4 Adverse Reactions 1) Possible skin irritation or electrode burn under the electrodes may occur. 2) Possible allergic skin reaction to tape or gel may occur. 3) If symptoms of tachycardia and extrasystolia (rapid heartbeat or extra stimulation) appear during treatment, stop the treatment and seek medical attention immediately.
  • Page 10 3.1 LCD Display Function Description Function Description Icon for Channel 1 Memory Icon Treatment Mode Treatment Time Pulse Width, Pulse Rate Low Battery Icon P01 to P02 Programmes Icon for Channel 2 3.3 Device Illustration Front Telephone: 0161 429 7330...
  • Page 11 Back Side Function Description Lead Connector Intensity Control (ON / OFF Switch) Panel Cover Liquid Crystal Display Mode Control Set Control Increment Control Decrement Control Battery Strip Battery Case Belt Clip Case Protector www.med-fit.store...

  • Page 12: Specification

    4 SPECIFICATION 4.1 Technical Information Device name Med-Fit 3 TENS Model / type R-ClOll Power sources One 9 volt battery Output channel Dual channel Waveform Bi-phase square-wave pulse Output current 0-S0V (Load:500 ohm) Output intensity adjustable Treatment mode TENS mode Operating condition 5’...
  • Page 13 Modes B (Burst), N (Normal), M (Modulation) SDl (Strength Duration) 5D2 and 7 preset programs from P0l to P07. Burst Mode Burst rate: adjustable, 0.5 -5 Hz, Pulse with adjustable, 50-300 µs Frequency fixed= 100 Hz Normal Mode The pulse rate and pulse width are adjustable. It generates continuous stimulation based on the setting value.
  • Page 14 SD2 Mode The SD2 (Strength-Duration) mode consists of automatic modulation intensity and pulse width in the 70% range. The intensity and pulse width are in 70% range. The intensity is always increasing while the pulse width is decreasing and vice versa. The intensity is decreased by 70% in 5 seconds.
  • Page 15 The waveforms of the 5 stimulation modes are as follows. 1. Burst 2. Normal 3. Modulation 4. SDl (Strength-Duration) 5. SD2 (Strength-Duration) www.med-fit.store...
  • Page 16 5. OPERATING INSTRUCTIONS 5.1 Battery 5.1.1 Check/ replace batteries Open the battery cover, insert one 9 volt battery into the bat tery compartment. Make sure you are installing the batter ies properly. Be sure to place the batteries according to the markings of positive terminal (+) and negative terminal (-) in the battery compartment of device.
  • Page 17 5. Replace all of the batteries simultaneously! 6. Always replace the device with the same type battery. 5.2 Connect electrode pads to electrode wires Insert the electrode wires connector into electrode connec tor. Make sure they are properly connected to ensure the good performance. Please refer to the picture.
  • Page 18 5.4 Electrode 5.4.1 Electrode options The electrodes should be routinely replaced when they start to lose their adhesiveness. If you are unsure of your electrode adhesive properties, please order new replace ment electrodes. Replacing electrodes should be re-or dered under the advice of your physician or the device manufacturer to ensure proper quality.
  • Page 19 4. To remove or move the electrodes, switch off the device or the appropriate channel first in order to avoid unwant ed irritation. 5. It is recommended that, at minimum, l.S”x 1.5” self-ad hesive square electrodes are used at the treatment area. 6.
  • Page 20 Position of electrode placement using aTENS treatment Neck Shoulder Hand Back Abdomen Telephone: 0161 429 7330...
  • Page 21 Foot Joint (Knee) Joint (Elbow) Joint (Ankle) Joint (Wrist) www.med-fit.store...
  • Page 22 6. INSTRUCTIONS FOR USE 6.1 Power On/Off Switch and Intensity Controls: If both controls are in the off-position, the device is switched off. By turning the controls clockwise, the appro priate channel is switched on and the indicator of power (CH! or CH2) will reveal on the LCD. The current strength of the impulses transmitted to the electrodes increases fur ther when the control is turned clockwise.
  • Page 23 Plug Lead Connector Lead Wire Electrode Socket 6.3 Mode Control There are 5 Modes and 7 preset modes available - Burst, Normal, Modulation, SD1 SD2 and P01-P07 preset modes. The therapeutic mode can be selected by pressing the “Mode” control. Burs t 6.4 Configuration Control By pressing the “SET”...
  • Page 24 6.7 Timer The unit: has a timer of 1- 60 minutes and Continuous. It can be adjusted by pressing the”Set” and”lncrement” or” Decrement”controls. The treatment time will countdown automatically one minute by one minute. Its output will be shut off when time is up. 6.8 Low Battery Indicator A low battery indicator will show up on the liquid crystal display when the battery needs to be replaced.
  • Page 25 c. Set Pulse Width Pulse Width is adjustable from 50 µs to 300 µs. Press “SET” control to enter this menu, then press “Increment” or “Dec rement” to adjust the setting. If no instructions regarding the pulse width are given in therapy, set the control to the suggested 70-120 µs setting.
  • Page 26 6.10 Patient Compliance Meter This unit can store 60 sets of operation records. Total treat ment time up to 999 hours can be stored. Check and Delete Individual Records Press “Mode” control and tum on the power simultaneous ly. The LCD will show the number of records and operation time.
  • Page 27 Note the polarity indicated on the battery and in the compartment. 5. Replace the battery compartment cover and press to close. Notice of batteries: 1. Batteries may be fatal if swallowed. Therefore, keep the batteries and the product out of the reach of children. If a battery is swallowed, go to a hospital immediately.
  • Page 28 5. Do not use the electrode pads more than 15 times, as the connection between the electrodes and your skin deteriorates over time. The adhesive effectiveness of the electrodes may vary based on skin properties, storage conditions, and the number of applications. If the electrode pads no longer stick fully to your skin, please replace them with new ones.

  • Page 29: Cleaning And Maintenance

    2. Do not use any adhesive electrodes with a size smaller than those the original manufacturer attached. Other wise the current density may be too high and cause inju ries. 3. The size of the adhesive pads may not be changed, e.g. by clipping off parts of them.
  • Page 30 7.1.3 The Combo Electrotherapy Device is sensitive to heat and may not be exposed to direct sunlight. And do not place it on hot surfaces. 7.1.4 For reasons of hygiene, each user should use his/her own set of electrodes. 7.1.5 Do not use any chemical cleaners or abrasive agents for cleaning. 7.1.6 Ensure that no water penetrates into the machine.

  • Page 31: Troubleshooting

    8. TROUBLESHOOTING Should any malfunction occur while using the device, check whether the parameters are set appropriately for therapy, and adjust the control correctly. Please see the fol lowing table: Malfunction Common reasons Countermeasure No display after replacing 1. There’s foreign body in 1.
  • Page 32 Malfunction Common reasons Countermeasure 1. The electrode does 1. Check and re-paste it No sensation of not connect well to on skin. stimulation the skin. 2. Poor connection 2. Check the connection. between the patient lead and the electrode 3. The battery is used up. 3.
  • Page 33 9. STORAGE 9.1 Storing The Electrode Pads and Lead Wires 1. Turn the device off and remove the lead wires from the unit. 2. Remove the electrodes from your body and disconnect the lead wires from the electrodes. 3. Place the electrodes onto the plastic film and then store into the sealed package.
  • Page 34 11. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES Guidance and manufacture’s declaration - electromagnetic emissions. The device is intended for use in the electromagnetic environment specified below. The customer or the user has to assure that it is used in such environment. Emissions test Compliance Electromagnetic environment- guidance...
  • Page 35 Immunity test IEC 60601 Compliance level Electromagnetic environment-guidance Test level Electrostatic ±8kV direct & ±8kVdirect & Floors should be wood, discharge (ESD) indirect contact; indirect contact; concrete or ceramic IEC61000-4-2 ±l5kV air ±l5kVair tile. If floors are discharge discharge covered with synthetic material, the relative humidity should be at least 30%...
  • Page 36 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 environment. Immunity IEC 60601 Compliance Electromagnetic environment-guidance level test Test level...
  • Page 37 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.
  • Page 38 As an alternative to FM modulation, 50% pulse mod-ulation at 18 Hz may be used because it does not represents actual modulation. It would be worst case. Declaration of conformity: Shenzhen Roundwhale Technology Co., Ltd. declares that the device complies with following normative documents: IEC60601-1, IEC60601-1-2, IEC60601-1- 11, IEC60601-2-10, IEC62304, ISO10993-5, ISO10993-10, ISO10993-1,ISO10993-23, ISO14971.
  • Page 39 12. NORMALISED SYMBOLS WEE Symbol Applied part of type BF Refer to instructions IP classification Authorised representative in the Batch code European Community Authorised representative in the Manufacturer United Kingdom Fragile, handle with care Date of manufacture Keep dry Keep away from sunlight Use by date Temperature limit Humidity Limitation...
  • Page 40 Tel: 0161 429 7330 Fax: 0161 427 0215 Email: sales@med-fit.co.uk www.med-fit.store Company registration number 08758741 Vat registration number 308286105 Shenzhen Roundwhale Technology Co.,Ltd. 202,2/F,Building 27,Dafa Industrial Park,Longxi Community,Longgang District,Shenzhen,China E-mail: info@roovjoy.com Shanghai International Holding Corp. GmbH(Europe) Eiffestrasse 80,20537 Hamburg, Germany E-mail:shholding@hotmail.com UK Representative: Wellkang Ltd, 16 Castle Street, Dover, CT16 1PW.

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R-c101i

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