Related Manuals for cefar Direct TENS
Summary of Contents for cefar Direct TENS
- Page 1 Direct TENS ™ Transcutaneous Electrical Nerve Stimulator for Pain Treatment USER GUIDE...
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Page 2: Table Of Contents
General Information ................................ 5 Key to the Symbols ................................6 Points to Note Before Use ..........................7 How Does the Direct TENS™ Device Function? ..................11 2.1. TENS Therapy Principle ............................12 2.2. Description of the Programs and the Corresponding Indications ...........13 Preparation ................................ -
Page 3: Quick Start Guide
Direct TENS ™ QUICK START GUIDE Insert batteries Attach belt clip and close battery compartment Connect the electrodes to the leadwire Apply the electrodes. The electrode placement depends on the indication, see also chapter 2.2 / page 13 Connect the electrode leadwire to the device... - Page 4 Direct TENS ™ QUICK START GUIDE Switch the therapy unit on Select a program (only possible when intensity = 0) The program depends on the indication to treat, see also chapter 2.2 / page 13 Set intensity for selected channel After approx.
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Page 5: General Information
™ GENERAL INFORMATION • The product Direct TENS™ bears the CE marking CE-0473 (Notified Body: AMTAC Certification Services Limited) showing that it complies with the Council Directive 93/42/EEC as amended concerning medical devices and fulfils the essential requirements of Annex I of this directive. It has an internal power source and is classified as IIa equipment (MDD). -
Page 6: Key To The Symbols
Direct TENS ™ KEY TO THE SYMBOLS Reference number, part number Follow instruction for uses Type BF applied parts Council Directive 2012/19/EU concerning Waste Electrical and Electronic Equipment (WEEE) requires not to dispose of WEEE as municipal waste. Contact your local distributor for... -
Page 7: Points To Note Before Use
1. POINTS TO NOTE BEFORE USE Intended Use Contraindications Direct TENS™ (882700) is a transcutaneous Do not use Direct TENS™ in the following situations: electrical nerve stimulator. Transcutaneous electrical nerve stimulation (TENS) uses electrical pulses that • If you have an implanted demand pacemaker,... - Page 8 Direct TENS ™ PRECAUTIONARY MEASURES Contraindications • Implanted electronic devices. Do not use the device on patients who have a cardiac pacemaker, implanted defibrillator, or other implanted electronic device, because this may cause electric shock, burns, electrical interference, or death.
- Page 9 Direct TENS ™ • Accessories. Use this device only with the leads, electrodes, and accessories recommended by the manufacturer. Use of other accessories may adversely affect the performance of the device or may result in stronger electromagnetic emissions or reduce the electromagnetic immunity of the device.
- Page 10 Direct TENS ™ • Batteries. Do not carry batteries in a pocket, purse, or any other place where the terminals could become short-circuited (e.g. by way of paper clip). Intense heat could be generated and injury may result. Never open the battery cover during stimulation in order to avoid electrical shock. Remove the batteries from the device if you do not intend to use it for a prolonged period of time (more than 3 months).
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Page 11: How Does The Direct Tens™ Device Function
™ 2. HOW DOES THE DIRECT TENS™ DEVICE FUNCTION Via electrodes attached to the skin, Direct TENS™ sends electrical pulses to the nerves. This will block the pain impulses. Four electrodes – two for each channel – can be connected to the device. Pain relief is most efficient during stimulation, but the effect can last after the treatment. -
Page 12: Tens Therapy Principle
Direct TENS ™ 2.1. TENS Therapy Principle Two pain theories play an important role in the application and parameter settings of the Direct TENS™ device: • The Gate Control Theory by WALL and MELZACK (1965) • The Endorphine Theory by ERIKSON and SJÖLUND (1979) According to the Gate Control Theory, weak TENS impulses block the pain impulses travelling to the brain (sensor stimulation). -
Page 13: Description Of The Programs And The Corresponding Indications
Direct TENS ™ 2.2. Description of the programs and the corresponding indications Frequency General Program Stimulation Advantages (Hz) Indications 1 impulse every 2 seconds Kaada TENS Ideal for sensitive people (similar to acupuncture) Supports acupuncture treatment Double pulse at 20 Hz... - Page 14 Direct TENS ™ Program Stimulation Frequency General Advantages (Hz) Indications Random modulation of Random Chronic pain Avoids habituation intensity and frequency modulation resisting therapy (down to 50% of set intensity Sensory as well as and frequency modulation motor stimulation between 8 different...
- Page 15 Direct TENS ™ Frequency Selection for Programs 9 to 13 2 – 60 Hz 60 – 150 Hz Preferred in the treatment of chronic pain Preferred in the treatment of acute pain With the standard TENS programs 9 to 13, the frequency can be adapted manually.
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Page 16: Preparation
Direct TENS ™ 3. PREPARATION 3.1. Inserting Batteries • Adjust the belt clip until it points to the right at a 90° angle. (Figure 3-1) • Push the battery cover down and lift. (Figure 3-2) • Insert the batteries as shown in the illustration. -
Page 17: Selection, Care And Placement Of The Electrodes
Direct TENS ™ 3.3. Selection, Care and Placement of the Electrodes 3.3.1. Electrode Selection Use large electrodes (e.g. 50 x 90 mm, to be purchased separately) for large body areas (e.g. back, leg) and for general conditions of pain. Use small electrodes (e.g. 50 x 50 mm) for small body areas (e.g. - Page 18 Direct TENS ™ 3.3.3. Electrode Placement If your physician showed you the best application Caution points, we recommend that you use them. Failed stimulation, skin irritation, malfunction - Otherwise figures 3-7 to 3-11 show possible electrode • Use only the original electrodes supplied configurations.
- Page 19 Direct TENS ™ Figure 3-12 Electrode application on the shoulder blade Indications: Figure 3-11 Electrode application in pain e.g. General pain in the shoulder conditions involving the shoulder and accompanied by headache shoulder blade Figure 3-14 Electrode application on the...
- Page 20 Direct TENS ™ Figure 3-16 Electrode application on Figure 3-17 Electrode application the knee joint on the back Indications: Indications: e.g. arthrosis of the knee joint (gonarthrosis), e.g. lumbar spine syndrome, generalized pain in the knee, TEP lumboischialgia, pseudoradicular back pain...
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Page 21: Treatment
Direct TENS ™ 4. TREATMENT 4.1. Starting Therapy • Switch the stimulator on. Once switched on, the display will briefly show the software version. A functional test where all display indicators appear for a short time is performed. The initial screen appears next (Figure 4-2). -
Page 22: Ending Therapy
Direct TENS ™ 4.2. Ending Therapy The default setting of the Direct TENS™ device is continuous operation. If you want to end the therapy, switch off the device with the ON/OFF switch. When the therapy timer is activated, the device switches automatically off at the end of the programmed interval. -
Page 23: Special Direct Tens™ Functions
5. SPECIAL DIRECT TENS™ FUNCTIONS 5.1. Therapy Timer The Direct TENS™ stimulator comes with a therapy timer function. When the timer is activated, the remaining therapy time appears on the display. When this interval has elapsed, the device switches off automatically. -
Page 24: What To Do, If
Direct TENS ™ 6. WHAT TO DO, IF ...the stimulation feels unpleasant or different from previous sessions • Check whether – The device settings were changed. – The electrodes are correctly placed and applied on the skin. Electrodes with poor adhesion must be replaced. -
Page 25: Care, Storage, Battery Replacement, Disposal
Direct TENS ™ 7. CARE, STORAGE, BATTERY REPLACEMENT, DISPOSAL Taking care of and cleaning the Direct TensTM equipment is simple with the following instructions: • Keep stimulator and accessories in the original case when they are not in use. It may, however, be practical to allow the electrodes to remain on the body between treatments. -
Page 26: Ordering Information, Specifications
Direct TENS ™ 8. ORDERING INFORMATION, SPECIFICATIONS Ordering Information Electrodes used up? Questions about the product? We at DJO would be happy to help! To avoid wrong deliveries, please indicate the part numbers when ordering products: Part Number Product 42190 Electrodes, Square 5x5 cm Durastick, Wire, pkg. -
Page 27: Electromagnetic Compatibility (Emc) Tables
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Direct TENS™ Electrotherapy System is intended for use in the electromagnetic environment deified below. The customer or the user of the Direct TENS™ Electrotherapy System should assure that it is used in such an environment Emissions Tests... - Page 28 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Direct TENS™ Electrotherapy System is intended for use in the electromagnetic environment specified below. The customer or the user of the Direct TENS™ Electrotherapy System should assure that it is used in such an environment IEC 60601...
- Page 29 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Direct TENS™ Electrotherapy System is intended for use in the electromagnetic environment deified below. The customer or the user of the Direct TENS™ Electrotherapy System should assure that it is used in such an environment. Immunity...
- Page 30 RF communications equipment and the Direct TENS™ Electrotherapy System The Direct TENS™ Electrotherapy System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Direct TENS™ Electrotherapy System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Direct TENS™...
- Page 31 MDSS GmbH Schiffgraben 41 30175 Hannover, Germany DJO, LLC A DJO Global Company 1430 Decision Street Vista, CA 92081-8553 U.S.A. T: 1-800-592-7329 U.S.A. F: 1-760-734-5608 DJOGlobal.com...