Transcutaneous Electrical Nerve Stimulator

Transcription

1 Transcutaneous Electrical Nerve Stimulator Simple, effective pain relief *For the temporary relief of pain as part of current medication programme. Distributor Medi-Direct International Ltd. Unit 24, Wilford Industrial & Business Park Ruddington Lane, tingham, NG11 7EP, UK Thank you for choosing Paingone Easy. Please read this user manual carefully before use. Model: KTR-230

2 CONTRAINDICATIONS 1. Pregnant women, people with abnormally sensitive skin, heart disease, abnormal blood pressure, malignant tumor, serious cerebrovascular disease, acute disease or those currently under doctor s treatment, should consult a doctor before using this stimulator. 2. Do not use this stimulator on children or people with no ability to express their own consciousness. 3. Do not use this stimulator near the heart, on the head, mouth cavity, genitals or diseased skin 4. Patients with an implanted electronic device (for example a cardiac pacemaker) should not use electrical stimulation unless specialist medical authorisation has first been obtained. Paingone Easy - Quick Start Guide Thank you for choosing PainGone Easy. This simple device can help you to manage your pain to maintain a more active lifestyle. This guide will tell you how to get started and how to get the most out of your device. What is Paingone Easy? Paingone Easy is a Transcutaneous Electrical Nerve Stimulation Device (TENS). It is applied to your skin and emits controlled electrical pulses. Because it has no wires or complicated settings Paingone Easy is quick and convenient to use when you need it. Intended Use Paingone Easy is intended for the temporary relief of pain Device Overview ON/+ button Control unit OFF/- button Electrode pad Before using the device for the first time Insert the battery. On the reverse of the device is the battery cover. Slide this down and away from the device. 1 2

3 Insert 1x CR2032 battery, so that the + symbol is visible and facing toward you. Replace the battery cover. e: 2x batteries are included with the device. One is provided as a spare. Attach an electrode pad to the control unit, using the press studs. Remove the protective film from the electrode pad. The device is now ready to use. How to use Paingone Easy Apply the electrode pad to the desired area of the body. Ensure that the pad is firmly pressed against the skin. A poor connection will affect performance of the device. Press and hold the ON/+ button briefly to activate the device. The device will beep and a green light will show. Now, press the on/+ button repeatedly to increase the intensity to a level you find comfortable. If the intensity is too strong, press the OFF/ - button to reduce the strength of the pulses. The device will beep with each step up or down in intensity. There are 12 steps of intensity in total. Changing Modes While the device is in use, you can switch between 3 different treatment modes. To do this hold down the on/+ button. 3 Mode 1 Soft pulse Mode 2 Strong pulse Mode 3 Combination soft and strong pulse Switching modes will cause the intensity to reset to level 0. You will need to increase the intensity again using the on/+ button. Powering off The device will automatically cycle through a pre-set programme of therapeutic pulses. The treatment will last for 15 minutes. After this time the device will automatically turn off. You can also force the device to power off by pressing and holding the OFF/ button for 3 seconds. The device will beep and the green light will turn off. You can begin a new therapy session by re-activating the device with the on/+ button. The maximum recommended time for any therapy session is 60 min. If it is not attached to the skin the device will always automatically turn off after 1 minute, to conserve battery life. After using the device, replace the protective film onto the electrode pad. Store the device in a dry, ventilated place. Replacing the electrode pads Each electrode pad can be used approximately 80 times (based on 2 uses per day, with 15 minutes application time). When an electrode pad has lost its stickiness entirely it should be replaced with a brand new pad. ONLY USE OFFICIAL PAINGONE EASY ELECTRODE PADS WITH THIS DEVICE. Please do not try to attach any other electrode pad to this product. ONLY USE ONE PAIR OF PADS PER USER OF THE DEVICE. To purchase replacement electrode pads contact Tower Health Ltd. Tel: enquiries@tower-health.co.uk Replacing the battery One CR2032 battery provides approximately 8 hours use. Once the battery charge is exhausted, replace with a new, fully charged battery. Further notes on usage If Paingone Easy is not in contact with the skin, it will not emit an electrical pulse. The treatment intensity will not be adjustable if the electrode has poor contact with your skin. Cleaning and maintenance Keep the surface of electrode pads clean. Avoid dust, oily matter and viscous matter. These can cause the adhesiveness of the electrode pads to decline. 4

4 The electrode pads can be washed to restore adhesiveness. Remove the pad from the device before washing. Allow to dry thoroughly before re-attaching to the control unit. The control unit does not require maintenance or calibration. Do not attempt to open the control unit for any reason. If a fault is suspected, contact the point of purchase. Please remove the batteries if the stimulator is not to be used for a long time. Storage 1) Please keep the stimulator out of reach of children 2) Do not store the device in places where it will be exposed to direct sunlight, high temperature or moisture. 3) Please store the device in a dry and ventilated space 2. Product disposal In order to avoid environmental pollution, please dispose this Device according to local environmental requirements. Do not discard in your standard waste disposal. Troubleshooting There is no output (electrical pulses) or the output feels low The battery is running low or running out The electrode pad is damaged or dirty, has no stickiness or is making poor contact with the skin Skin is too oily The device is damaged Replace the battery Replace with a new electrode pad Wipe skin with a wet towel or alcohol Allow to dry fully before using the device Contact the point of purchase Problem Analysis of cause Recommended Solution The device does not power up correctly The buttons are not functioning correctly The battery is installed incorrectly The battery is running low or running out The button is damaged The battery is running low or running out The button is damaged Use CR2032 button batteries. Please install the battery properly with the + pole facing upwards and the - pole facing downwards Replace the battery Contact the point of purchase Replace the battery Contact the point of purchase The skin is strongly irritated/shows signs of redness The treatment has been applied too long The intensity is set too high The electrode pad is not making good contact with the skin There may be an allergic reaction to the electrode pad The electrode pad is dirty Limit treatments to 15 minutes Decrease the intensity to a more comfortable level Press the electrode pad firmly against the skin to improve contact Cease use of the device Clean the electrode pad The device does not emit any "beep" sound The speaker is damaged Contact the point of purchase 5 6

5 3. Technical parameters and specification 4. Safety precautions 3.1 Product specification Product Name Transcutaneous Electrical Nerve Stimulator Model KTR-230 Power supply d.c.3v 30mA CR2032 Safety category BF type Product service life 3 years Product dimensions Φ (mm) Storage time 6 months software version KTR A-V Environmental conditions Temperature Normal working condition Storage condition Transportation condition Electrical performance Pulse frequency 1Hz 120Hz Pulse width 20μs 400μs Direct current component 0V Peak pulse voltage <60V Electric quantity of single pulse when the output amplitude is maximum 7μC Maximum output energy of single pulse 300mJ The effective value of maximum output amplitude 25V 50mA The peak value of output voltage when conducting open loop measurement 500V The effect of output end open circuit and short circuit Adjustment of output amplitude Rated load impedance Timing time of therapy stimulator The average working time with no malfunction Product software version No. 7 Humidity Barometric pressure 15%-93%RH 700hPa-1060hPa 0-93%RH 700hPa-1060hPa 15%-93%RH 700hPa-1060hPa Can endure the effect of output end open circuit and short circuit and the performance should not be weaken. Continuous and uniform, minimum output should be no bigger than 2% of maximum output. 500Ω with a permissible deviation of ±10% 15 minutes with a permissible deviation of ±10% 1000 hours KTR A- V1.0 The purpose of the warning signs and symbols in this user manual is to make sure that the user can use this product safely and correctly, and thus prevent damage to the user or other people. Warning signs, symbols and their meanings are as follows: Warning signs Danger Warning Attention Meaning Indicate when wrongly used, it may cause personal casualty or serious injury. Indicate when wrongly used, there is a possibility of personal casualty or serious injury. Indicate when wrongly used, there is a possibility of personal injury or things get damaged. Danger Never use this stimulator along with other medical electronic stimulators, such as cardiac pacemaker, artificial heart-lung which are used to maintain life, and electrocardiograph. Otherwise it may cause danger. If the user is using high frequency surgical equipment and this therapy stimulator at the same time, then there might be burn in the place where the electrode slice is pasted to or damage to the stimulator; If this stimulator is used in the vicinity (1m) of short wave or microwave therapy stimulator, then the output of this stimulator might not be stable. Warning 1. Do not use this stimulator in places where there are high heat, inflammables and electromagnetic radiation. 2. Do not use this stimulator while bathing or sleeping. 3. Do not modify the stimulator, or else electric shock might occur. 4. Do not inhale or swallow small parts, which might lead to life-threatening condition. 5. Do not conduct servicing or maintenance while the device is in use. 6. Do not apply the electrodes near the thorax, which may increase 8

6 the risk of cardiac fibrillation. 7. Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the front of the neck, (especially the carotid sinus), on private parts, parts with skin disease, or from electrodes placed on the chest and the upper back or crossing over the heart. Do not arbitrarily disassemble, repair and reform this stimulator, otherwise it might cause malfunction or electric shock accidents. Attention 1.Do not move the stimulator while using, or when the user wishes to change treated area, first be sure to turn off the stimulator then use it, or it might cause strong stimulation. 2. If the user doesn t feel well due to stimulator anomaly, please stop using at once and consult a doctor. 3. If the stimulator is not to be used in a long time, please take out the battery to avoid leakage which may damage the stimulator. 4. Do not use this stimulator under circumstances that are beyond the range of application. 5. Do not use or contact with the product for a long time. 5. EMC statement Models KTR-230 need special precautions regarding EMC and need to be installed and put into service according to the EMC information provided in the accompanying document; Portable and mobile RF communications equipment can affect models KTR-230. Warning: 1) The use of accessories, transducers and cables other than those specified with the exception of transducers and cables sold by the manufacturer of the models KTR-230 as replacement parts for internal components, may result in increased emissions or decreased immunity of the models KTR ) Models KTR-230 should not be used adjacent to or stacked with other equipment Guidance and Manufacturer s declaration can be seen in the attachment. Contraindications 1. Pregnant women, people with abnormally sensitive skin, heart disease, abnormal blood pressure, malignant tumor, serious cerebrovascular disease, acute disease or currently under doctor s treatment, should consult a doctor before use this stimulator. 2. Do not use this stimulator on children or people with no ability to express their own consciousness. 3. Do not use this stimulator near the heart, on the head, mouth cavity, private parts, parts with skin disease and so on. 4. Patient with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to stimulation unless specialist medical opinion has first been obtained. 6. Symbols Graphic symbol Meaning Product batch number symbol Product serial number symbol 9 10 Is the battery low Replace new

7 EC REP Manufacturer Date of manufacture Authorised representative in the European community Caution RF emissions CISPR 11 Group 1 The models KTR-230 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. Danger warning BF type applied part Indoor use only Prohibition (things that are not allowed to do) Constraint (things that shoule be obeyed) Avoid sunlight Low-frequency electromagnetic radiation Keep dry RF emissions CISPR 11 Harmonic emissions Voltage fluctuations /flicker emissions Class B The models KTR-230 are suitable for use in all establishments, including domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes CE symbol and ified body code WEEE (Waste Electrical and Electronic Equipment). The waste products should be handled legally. Guidance and manufacturer s declaration electromagnetic immunity IP22 Product package should be recycled. Dustproof waterproof level. It can prevent solid object larger than 12mm from intruding, and when tilt for 15 degrees, it can still prevent waterfrom intruding, so no harmful effect will be created. CAUTION, Avoid injury. Read and understand owner s manual before operating this product. The models KTR-230 are intended for use in the electromagnetic environment specified below. The customer or the user of the models KTR-230 should assure that it is used in such an environment.ment. Immunity test test level Compliance level Electromagnetic environment --guidance 7. Attachment Electrostatic discharge (ESD) ±8 kv contact ±2 kv, ±4 kv, ±8 kv, ±15 kv air ±8 kv contact ±2 kv, ±4 kv, ±8 kv, ±15 kv air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Guidance and manufacturer s declaration electromagnetic emissions The models KTR-230 are intended for use in the electromagnetic environment specified below. The customer or the user of the models KTR-230 should assure that it is used in such an environment. Emissions Compliance Electromagnetic environment-- guidance Electrical fast transient/ burst Surge ±2kV for power supply lines ±1 kv for Input/ output lines ±1 kv line to line ±2 kv line to earth Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment

8 Voltage dips, short interruptions and voltage variations on power supply input lines <5 % UT (>95% dip in UT.) for 0.5 cycle 40 % UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95 % dip in UT) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. If the user of the models KTR-230 requires continued operation during power mains interruptions, it is recommended that the models KTR-230 be powered from an uninterruptible power supply or a battery. Conducted RF Vrms 150 khz to 80 MHz 6 Vrms in ISM bands Portable and mobile RF communications equipment should be used no closer to any part of the models KTR-230, including cables, than the recommended separation distance calculated from the equation to the frequency of the transmitter. Recommended separation distance Power frequency (50/60 Hz) magnetic field NOTE Guidance and manufacturer s declaration electromagnetic immunity The models KTR-230 are intended for use in the electromagnetic environment specified below. The customer or the user of the models KTR-230 should assure that it is used in such an environment. Immunity test 30 A/m test level 30 A/m Compliance level Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. UT is the a.c. mains voltage prior to application of the test level Electromagnetic environment guidance Radiated RF V/m 80 MHz to 2.7 GHz 385MHz- 5785MHz Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communication equipment (Refer to table 9 of : 2014) 10 V/m 80 MHz to 2.7 GHz 385MHz- 5785MHz Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communication equipment (Refer to table 9 of : 2014) d=[3,5/v1] P 1/2 d=1.2 P 1/2 80 MHz to 800 MHz d=2.3 P 1/2 800 MHz to 2.7 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 meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a 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: 13 14

9 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 models KTR-230 are used exceeds the RF compliance level above, the models KTR-230 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the models KTR-230. 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 models KTR-230 The models KTR-230 are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MODEL KTR-230 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the models KTR-230 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150kHz to 80MHz d=1.2 P 1/2 80MHz to 800MHz d=1.2 P 1/2 800MHz to 2,5GHz d=2.3 P 1/ For transmitters rated at a maximum output power not listed above, the recommended separation distanced in metres (m) can be estimated using the equation 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. Warranty Please retain this warranty for reference in case after-sales repair or maintenance is required. The terms of the warranty are as follows: Under normal operating conditions this product is covered by a one-year warranty against manufacturing fault. In the unlikely event of a manufacturing fault being encountered during this period, the device will be repaired or replaced free of charge. Cover is from the date of receipt. Accidental damage or damage caused through misuse is not covered by this warranty. Shenzhen Kentro Medical Electronics Co.,Ltd N0.3, Xihu industry zone, Xikeng Village, Henggang Town, Longgang District, Shenzhen, Guangdong, China Wellkang Ltd Suite B, 29 Harley Street LONDON W1G 9QR, England, United Kingdom Tel: +44 (20) , Fax: +44(20)