Well Life Healthcare WR2605AOTCTX Wireless Electrical Stimulator User Manual
Well-Life Healthcare Limited. Wireless Electrical Stimulator
User manual
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OPERATION MANUAL WELL LIFE Wireless TENS/EMS Stimulator Model no. WR-2605A (OTC) WELL LIFE HEALTHCARE LTD. 1Fl, No.16, Lane 454, Jungjeng Rd., Yunghe District, New Taipei City 23455, Taiwan Operation Manual Read Before Using 0120 IM-WR2605A-USA Date: 2016-4-19 TABLE OF CONTENTS INDICATIONS AND CONTRAINDICATIONS..………………………………… WARNINGS AND PRECAUTIONS……………………………………………… GENERAL INFORMATION ………………………....……………………………. ABOUT RECHARGEABLE BATTERY ………………. ……..…………………. Charging the Remote Using the AC Adaptor……………..…………………… Charging the Receiver………………………………………………………………… Charging the System via USB Port…………………………… STEP BY STEP OPERATION GUIDE FOR TRAINING ……..………………… Preparing Skin for Running a Session……………………………………………………. Placement of Electrodes ………………………………………………………………….. Turning ON/OFF Remote Control………………………………………………………….. Turning ON/OFF Wireless Unit…………………………….……………………………… Communication between Remote and Receiver(s) ……………………………………. Selecting the Program.…………………………………………………………………….. Selecting the Therapy Intensity Level… ………………………………………………… Selecting the Therapy Time………………………………………………………………. CARE AND MAINTENANCE…………………………………………………........ 16 TROUBLESHOOTING.………..……………………………………………….… ... 17 TECHNICAL SPECIFICATIONS…………………………………………………… 18 FCC STATEMENT ..…………………………………………................................ 23 WARRANTY…………………………………………............................................. 24 INDICATIONS AND CONTRAINDICATIONS Read the operation manual before using. Read instruction manual before operation. Be sure to comply with all “CAUTIONS” and “WARNINGS” in the manual. Failure to follow instructions can cause harm to user or device. Observe your physician’s precise instructions and let them show you where to apply the electrodes. For successful therapy, the correct application of the electrodes is an important factor. Indications for use The WR-2605A (OTC) is a dual channel digital electrical stimulator for active treatment application as the following intended use: Transcutaneous Electrical Nerve Stimulator (TENS) can be used for the following applications: For temporary relief of pain associated with sore and aching muscles in yours shoulder, upper and lower back due to strain from exercise, normal household chores and work related activities. Electrical Muscle Stimulator (EMS ) stimulation can be used for the following applications: To stimulate healthy muscles in order to facilitate muscle performance. Relax muscle spasms Prevent or retard disuse atrophy Re-educate muscles Maintain or increase the range of motion WARNINGS AND PRECAUTIONS Warnings If you are under the care of a Physician, consult with your Physician before using this System. The long-term effects of this System are not known. Do not place the pads on or close to your heart. Do not place the pads around or close to your neck. Do not apply stimulation over the neck. Severe spasm of the muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing. Stimulation over the neck could also have adverse effect on hearing or blood pressure. Do not apply stimulation across the chest because the introduction of electrical current into the chest may cause rhythm disturbances to the heart. Do not place the pads on or around your head. The effects of stimulation of the brain are unknown. Do not use the pads over or close to sores. Do not place the pads on the front or sides of the neck across or through the heart (one pad on the front of the chest and one on the back), in the genital region, or on the head, because of the risk of stimulating inappropriate muscles and organs. Do not place the pads over any recent scars, broken or inflamed areas of infection or susceptibility to acne, thrombosis or other vascular problems (e.g. varicose veins), or any part of the body where feeling is limited. Do not place the pads over areas of injury or restricted movement (e.g. fractures or sprains). Do not use this System while sleeping. Do not use if you feel numbness. Do not use this System in or close to water. Do not apply stimulation across the chest because the introduction of electrical current into the chest may cause rhythm disturbances to the heart, which could be lethal. Do not use the pads over or close to cancerous lesions. Use the pads only on normal, healthy, clean and dry skin. Do not use the pads on open wounds or rashes, or over swollen, red, infected or inflamed skin. If you have ever had back surgery, consult your Physician before using this System. Electronic monitoring equipment (such as ECG and ECG alarms) may not operate properly when electrical stimulation is in use. You must position the pads and operate the unit ONLY as indicated in this manual. Avoid areas in injury or restricted movement (e.g. fractures or sprains) Avoid placing the pads over metal implants. Do not use in the bath or shower, or in an environment of elevated humidity (e.g. Sauna, hydrotherapy, etc). Operation in close proximity, such as 3 feet (1 meter), to shortwave or microwave therapy equipment may produce instability in the device output and may shut the device off. Do not use the device in an environment where flammable or explosive fumes may exist. Patient should never operate potentially dangerous machinery such as power saws, automobiles, etc. during electrical stimulation. It might result in burs at the site of the stimulator electrodes and possible damage to the stimulator if you connect to high frequency equipment. Application of electrodes near the thorax may increase the risk of cardiac fibrillation. The system is internally powered (power form battery pack), IP 22, continuous operation. Wait before using the unit : At least 6 weeks after the birth of your baby (you must consult your doctor before use). One month after an IUD contraceptive device (e.g. coil) has been fitted (you must consult your doctor before use). At least 3 months after having a caesarean section (you must consult your doctor before use). The heavy days of your period have finished, because vigorous abdominal exercise is not recommended at this time. Precautions Read User Manual before using this System for the first time. Keep this manual available whenever you use your System. The System is intended for personal use on healthy adult muscle only. The safety of using the System during pregnancy or birth has not been established. The effectiveness of the System depends greatly on a person’s individual physical condition. It may not always be effective for every user. The safety of neuromuscular stimulation during pregnancy has not been established. Use caution when/if: - Sensory nerve damage is present by a loss of normal skin sensation. - Use caution prior to using this device on patients suspected of having heart disease. - Use caution for patients with suspected or diagnosed epilepsy when using this device. - Use caution following recent surgical procedures when muscle contraction may disrupt the healing process. - Use caution when there is a tendency to hemorrhage, such as following acute trauma or fracture. - A menstruating or pregnant uterus. - Patient experiences skin irritation due to electrical stimulation or the electrical conductive medium used, remove the electrodes, discontinue stimulation, and consult the clinician. Irritation may be reduced by an alternative conductive medium or an alternative electrode placement. Isolated cases of skin irritation may occur at the site of electrode placement following long term application. Place electrodes in accordance with illustrations in the User Manual. This unit should not be used while driving, operating machinery or during any activity in which involuntary muscle contractions may place the user at undue risk of injury. Some users may experience skin irritation or hypersensitivity due to the electrical stimulation or the conductive medium. Keep this device out of the reach of children. If the patient is a child, make sure he/she is properly supervised during electrical stimulation. Strangulation resulting from baby or child entanglement in monitoring cables. Application of moderate heat (thermal wrap) to muscles as well as moistening skin prior to treatment improves treatment efficacy; use of cold packs on treated muscles after treatment is likewise recommended. This unit should only be used with the leads, electrodes and accessories provided by the manufacturer. The device is not intended for medical use, for the treatment of any medical condition or for any permanent physical changes. Contact Well-Life, or an authorized dealer, if your unit is not working correctly. Do not use in the meantime. An effective session should not cause discomfort. For first time users, muscle stimulation can be an unusual sensation. We recommend that you begin in a seated position with low stimulation intensity settings to familiarize yourself with the sensation before progressing to higher intensity settings. The leads and pads must not be connected to other objects. Do not over exert yourself while using muscle stimulation. Any workout should be at a comfortable level for you. Do not place pads over jewelry or body pierecings. Use Caution and consult Physician before using System if any of the following conditions apply to you: You have any serious illness or injury not mentioned in this guide. You have recently undergone a surgical procedure. You take insulin for diabetes. You use the unit as part of a rehabilitation program. If you have suspected or diagnosed heart problem. If you have suspected or diagnosed epilepsy. If you have a tendency to bleed internally following an injury. If you recently had surgery, or have ever had surgery on your back. If areas of skin lack normal sensations, such as skin that tingles or is numb. During menstruation or during pregnancy. Some people may feel skin irritation or experience a very sensitive feeling in the skin due to electrical stimulation. If this occurs, stop using your System and consult your Physician. If skin under one of more pads feels irritated after using the stimulator for a long period of time, use the stimulator for a shorter period of time. Minor redness at stimulation placement is a normal skin reaction. It is not considered as skin irritation, and it will normally disappear within 30 minutes after the electrodes are removed. If the redness does not disappear after 30 minutes from the removal of electrodes, do not use the stimulator again until after the excessive redness has disappeared. Turn off the stimulator if the stimulation feels unpleasant or does not provide pain relief. Keep your System out of the reach of children. Use your stimulator only with the pads, snap cables and accessories recommended by the manufacture. Do not use this System when driving, operating machinery or when swimming. Before removing the pads, be sure to power off device to avoid unpleasant stimulation. After strenuous exercises or exertion: Always use lower intensity to avoid muscle fatigue. Important : Effectiveness is highly dependent upon patient selection by a clinician qualified in the management of pain or rehabilitation. Do not use your unit at the same time as any other device, which transfers an electrical current into the body (e.g. another muscle stimulator). Cease using your unit if you are feeling light headed or faint. Consult doctor if this happens. Do not touch the pads or metal studs while the unit is switched on. Do not use unit if you are wearing a belly button ring. Remove ring before session. Use the device with only the leads and electrodes provided for use by the Well-Life with your device. Any others many not be compatible with your unit and could degrade the minimum safety levels. Use only the electrode placements and stimulation settings prescribed by your practitioner. This device is for external use only. Choking resulting from a child swallowing a small part that has become detached from the device. Note: If you are in any doubt about using device for any reason, please consult your doctor . Pad/Electrode Precautions To reposition the pads during a session, always pause the program currently running, reposition the pads and then restart the program. The pads are for single person use only. Do not plunge the pads into water. Do not apply solvents of any kind to the pads. Always ensure the unit is OFF before removing the pads. Apply the whole surface of the pads firmly to the skin. Do not use pads, which do not adhere properly to the skin. If your skin is red under the pad after a session, do not start another session in the same area until your redness has completed disappeared. Adverse Reactions You may experience skin irritation due to prolonged exposure to the stimulation electrodes applied to your skin. You may experience potential allergic reactions to accessible materials used in the electrodes. You may experience headache and other painful sensations during or following the application of electrical stimulation near your eyes and to your head and face. You should stop using the device and should consult with your physician if you experience adverse reactions from the device. Conditions that may affect your Well Life Wireless TENS/EMS System Since the stimulator is a battery-operated electronic System, its output performance and safety may be affected greatly in extreme humidity. Therefore, it is very important to keep the system device(s) dry to ensure the safety and performance of the stimulator. ● The patient may also be an intended operator, at least 15 years old and 8 years intensive reading experience( school), no maximum. ● This system is for home use, indoor, not intended for professinal use ● This system is for daily use, no operation time limit on device but it is recommended not exceeding 60 minutes per day. ● If there is any other problem, please cosult or return the device to your distributor. Do not try to repair a defective device. ● For plug-in equipment , the power outlet socket must be located near the equipment and must be easily accessible ● WARNING: No modification of this system is allowed. ● WARNING: Other cables and accessories may negatively affect EMC performance . ● WARNING: Do not stack and store theis system closed to other equipment. GENERAL INFORMATION Package Content 1. Remote x1 2. Receivers (Ch1 & Ch2) x2 3. Self Adhesive Electrodes Size: 150x100mm, 2 pcs/bag 4. USB Charging Cables x 2 (Length 60 cm ) 5. AC Adaptor x1 About Remore Control 1. 2. 3. 4. 5. 6. 7. Power ON key CH key SET key Power OFF + key ON + key : increase OFF key : decrease USB charger socket About Recivers 8. 9. 10. 11. CH1 Receiver : Power On/Off key CH2 Receiver : Power On/Off key Snaps for Electrode USB charger Socket About Rechargeable Batteries Please fully charge the batteries in both the remote unit and the receivers before using this device. Charging the Remote Using the AC Adaptor 1. Connect the small end of the USB cable to the remote and the larger end to the AC adaptor.. 2. Plug the adaptor into any standard wall outlet. When the remote has finished charging the battery an icon will indicate “full”. Charging the Receiver 1. Connect the small end of the USB cable to the receiver and the other end into the AC adaptor. 2. Plug the adaptor into any standard wall outlet. A Orange light indicates the receiver is now in charge mode, once fully charged the Orange light will change to Green indicating that the receiver is fully charged. ▲Note : for important precautions for use with AC adaptor , please be informed : To prevent the risk of electric shock, make sure power cord is unplugged from wall socket. To fully disengage the power to the unit, please disconnect the power cord from the AC outlet. Do not remove cover (or back). No user serviceable parts inside. Refer servicing to qualified service personnel. The AC outlet shall be readily available and accessible. ▲Note : for important precautions regarding the batteries please be informed: ● It is recommended to use a manufacturer supplied or approved battery charger in order to maximize battery life. ● Do not connect the battery to metal objects placed in your pocket or backpack or other containers. ● Do not short the metal (+)(-) terminals. Wishing to put batteries or electrical devices do not end when (+)(-) device error. ● Do not dismantle or modify the battery. ● Please do not take a hammer or other items to hammer blow, or throw batteries and trampling, falls, and fall causing a strong impact, heavy blow, etc. ● Do not use sharp utensils or metal objects to scratch or puncture the battery. ● Do not place the battery into a microwave, oven, or dryer. Do not place the battery into high-pressure or high temperature environments. ● Do not mix this product with other brands or other types of batteries ● Before charging or discharging the battery, read the manual. ● Stay away from conductive objects during battery charging and discharging. ● Keep batteries away from children. ● When the device(s) system is not in use, store in a low humidity, low temperature environment. ● In the event the battery fluid comes into contact with your eyes, do not rub your eyes. Rinse with water and immediately seek treatment. ● If you detect abnormal heat, odors, or flames coming from the battery, discontinue using the battery. ● If the battery fluid leaks and comes into contact with the skin, wash with clean water. ● Do not throw into a fire. ● When discarding or recycling batteries, make sure not to short-circuit (+)(-) the terminals. ● Please recycle. Do not dispose of old batteries with your household waste; dispose of them safely at your recycling centre or business where the batteries were purchased. STEP BY STEP OPERATION GUIDE FOR TREATMENT Preparing the Skin for Running a Session Proper preparation of the skin covered by the electrodes allows more stimulation to reach targeted tissues, prolongs electrode life, and reduces the risk of skin irritation. After connecting the wireless units to the electrode pads, use the following steps to prepare your skin at the electrode placement sites: 1. 2. 3. 4. Determine the placement sites for the electrodes. Wash the area with mild soap and water (do not use alcohol). Rinse and dry thoroughly. Trim excess body hair from the area with scissors (do not shave). Optionally, apply skin prep to the area to form a protective barrier on your skin. Apply, let dry, and apply electrode as directed. This will both reduce the chance of skin irritation and extend the life of your electrodes. 5. When removing electrodes, always remove by pulling in the direction of hair growth. 6. It may be helpful to apply skin lotion on electrode placement area when not wearing electrodes. Placement of Electrode 1.Place the electrode with the contact plugs up onto a flat surface. Place the wireless unit with the contact jacks down onto the Electrode pad so that plugs and jacks are aligned. Then press down until completely snapped in. 2. Do not remove the clear plastic shield from Electrode until the unit is ready to be placed on the body. Turning ON/OFF Remote 1. To turn on the Remote , press and hold the ON/+ button for one (1) second to turn on the device. All the treatment status displays clearly on the big LCD screen, with backlight for 10 seconds, with each entry of button. The most recently selected program will display on the screen. 2. To turn off the Remote, press and hold the OFF/- button for three (3) seconds to turn off the device. Or it will be automatically off when no button is pressed for 60 seconds. ▲Note: Do not turn the unit on until the receiver(s) are properly attached. ▲Note : When stimulating the muscles of the arms or legs bear in mind that the muscle contraction may cause involuntary limb movement which could cause injury to you or others. Always ensure the limb is secured to prevent movement. Turning On/Off Receiver 1. Turn on the receiver, press the Power button. 2. Green backlight will be lighted up, and lasting on 60 seconds, then it will light off if no other entry. 3. Green backlight of the receiving unit is then flashing whist the identical wireless unit receives the signal from the remote . 4. To Turn off the receivers , press and hold the OFF/- button for three (3) seconds. ▲Note: In an emergency you may take off the receiver(s) and electrodes directly from treatment site(s). ▲Note : To prevent unpleasant electric shocks, never remove off the device while it is still turned on. Communication between Remote and Receiver(s) 10 Radio Frequency Wireless technology 2.4G is used in this system, for good quality of service between the remote and wireless unit(s) requirement requires 3 meters (9 feet). 1. LCD symbol on the remote control and LED indicator guide on wireless unit(s): Indicator Description LCD symbol on Remote 1. It shows Mode, Timer, Intensity Level, and wireless unit by Channel number on the LCD display when Power ON, LED backlight for 10 seconds. 2. If the paired wireless is connected, it will display : or 3. If low battery symbol shows , battery power is low. When charging the remote , the device will shut off automatically. Receivers ( Ch1 / Ch2) : 1. When Power ON, Green LED light on. 2. LED in Green blinking on the Channel in use, when it receives signal transmitting from the Remote Control. 3. LED in Red Flashing, battery power is low. Receiver unit will turn on when charging the battery, Orange light lasting until fully charged, then it turns off. 2. There is one (1) Remote with two (2) receivers (Ch1 or Ch2 printed on the front) supplied for use with this system. Additional two (2) receivers (Ch3,Ch4) might be available for replacement purpose, please contact authorized distributors. 3. Whenever the receivers turns on, the remote control unit shall display the identical number of receiver(s) . Make sure the identical receiver is turned on and properly placed before setting up Program /Timer / Intensity Level. 4. The Remote will display treatment status on the LCD sequentially in turn to the Channel of receiver(s). Or, you could turn off the remote when all set. Selecting the Program 11 The Device offers 8 different preset treatment programs respectively for TENS and 6 programs for EMS modes; the programs differ with respect to varying pulse widths and frequencies. Choice of the appropriate mode and treatment program The mode you choose determines the kind of work that is imposed upon the stimulated muscles. Choose the mode that is appropriate to your needs or gives you the greatest pleasure. How to Select TENS/EMS Mode 1. Press the “SET” button , the preset (default) therapy mode TENS/EMS will flash on the display. Use ON + or the button OFF –, if you would like to change the therapy mode. 2. Press the SET button again, the numeric number of program is then flashing. 3. Press the button ON + (to increase) or the button OFF – (to decrease) for choice of program of the selected modality. ▲Note : Make sure the identical receiver is turned on and properly placed. For TENS programs: When using any of the 8 programs for pain relief always start with the lowest intensity and gradually increase the level of intensity until you feel a “tingling” sensation. All programs are different and therefore feel differently. You may try all 8 programs in the beginning and choose one that feels pleasant. Never increase the intensity to a level so that it hurts, always stay under the point of discomfort. Start with short sessions of 5 or 10 minutes until your body gets used to the stimulation. Program Max. P1 80mA P2 80mA P3 80mA P4 80mA P5 80mA P6 80mA P7 80mA P8 80mA All electrical specification ±20% Program./mode Phase duration 260uS 260uS 260uS 260~150uS 260~150uS 260uS 260~156 uS 210 uS Benefits Rate 15Hz 60Hz 60Hz 2 ~ 60Hz 60Hz 7 <->60Hz 60Hz 2.45~245 Hz Function mode Constant Modulated Constant Modulated Modulated Modulated Modulated Cycle You should feel 12 P1 Continuous comfortable tingling. The underlying pain should decrease gradually after treatment. -for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. P2 P3 Comfortable pulsing sensation. The underlying pain should decrease almost immediately. Comfortable pulsing sensation. The underlying pain should decrease almost immediately. - for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities ( arm and/or leg) due to strain from exercise or normal household and work activities. P4 Variable comfortable tingling and pulsing sensation (sensation should appear to come in waves). Pain should ease and there should be relief after treatment. P5 Variable comfortable mild tingling sensation (sensation will appear to come in waves). P6 Variable comfortable pulsing and pumping action (action will appear to come in waves). P7 Variable comfortable tingling and pumping action (action should appear to come in waves). -for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. P8 Variable comfortable tingling and pulsing sensation (sensation should appear to come in waves). Pain should ease and there should be relief after treatment. For EMS programs: When using the device for muscle stimulation (EMS) any of the 6 programs may be used. The intent is to cause a muscle to contract, and then release. All 6 programs will achieve contraction and vary mainly by the rate and duration of the contractions. As with any exercise regiment, start out slowly with low intensity levels for a warm-up (5~10min). You may increase intensity level and treatment time as you progress with your muscle performance. Use the device regularly over a longer period of time as to maintain the benefit you may have gained during “exercise”. Pulse Width (uS) P1 300 P2 200 P3 300 P4 200 P5 200 P6 300 All electrical specification ±20% Mode / Exercise Ramp up (sec) Hold on (sec) You should Feel & Benefits Ramp down (sec) Off Time (sec) 10 Suggestion 13 Pulse rate (Hz) 40~99 99 4~20 50 Program P1 Exercise Preparation P2 Active Recovery P3 Active Recovery P4 Active Recovery P5 Build Endurance P6 Muscle Strengthening This program gently warms up the muscles prior to exercise; it feels like a rhythmic massage. Increase the intensity until you get a strong but comfortable muscle movement, 10 min/duration. This program produces muscle twitches at very low frequency and it feels like a tapping massage, for muscle recovery from fatigue and becoming more relaxed with reduced stiffness. This program is similar to P2, except that the muscle twitch rate slows down during the session. It feels like a tapping massage, but softer than P2. This program activates the muscle in a short contraction/relaxation cycle. It feels like a kneading massage, smother than P2/P3. This program uses a low frequency pulse train which favours slow twitch fibers, for developing aerobic capacity and capillary supply. It improves fatigue resistance during long duration moderate intensity exercise. Use it after intense exercise to promote recovery and relaxation, 30 min/duration. This program uses a pulse frequency appropriate to fast twitch muscle fibers. It improves their anaerobic capacity and is used for improving maximum muscle strength. Selecting the Therapy Time 1. Press the “SET” button again, the preset (default) treatment time will flash on the display. 2. To increase or decrease the treatment time, press the button ON + (to increase) or the button OFF – (to decrease) repeatedly until the desired duration appears on the display. 3. The treatment time you selected will appear on the display the next time you turn the device on. ▲Note : If you change programs during the course of a therapy session, the treatment time will not set unless you manually reset it by performing the steps described above. Selecting the Therapy Intensity Level 14 Use it after intense exercise to promote recovery and relaxation, 20 min/duration. Use it after intense exercise to promote recovery and relaxation, 20 min/duration. The exercise comprises an alternating sequence of work and rest phases lasting several seconds. Increase the intensity until you get a strong and deep muscle contraction. Do not exceed your comfort level, 20min/duration. The exercise comprises a sequence of work phases separated longer relaxation phases. Increase the stimulation intensity until you get a strong and deep contraction. Do not exceed your comfort level, 20 min./Duration. The Device offers 25 intensity levels! Intensity is adjustable according to the receiver selected. Make sure the identical wireless unit is turned on and properly placed. 1. Press the “SET” button, the numeric number of program is then flashing. 2. To increase or decrease the intensity, press the button On+ (to increase) or the button OFF– (to decrease) repeatedly until the desired intensity level flashes on the display. ▲ Note: You will feel the intensity increase or decrease as you select the intensity level. You can use this as a guide to select a level that is comfortable for you. ▲ Note : If you change therapy mode/program during the course of a therapy session, the intensity level will reset to “0” for safety reason. CARE AND MAINTENANCE The Well-Life Wireless TENS/EMS System is recommended for single person use at home. Remote and Receivers The system device(s) may be wiped clean with a small amount of soapy water on a clean cloth. Do not submerge the stimulator in liquids or expose it to large amounts of water. For pet and pests consideration within the user area, you should clear the system device(s) each time before use and keep them safe away in a drawer or somewhere pets and children won’t be able to reach. Never use aggressive cleaning products of stiff brushes to clean the device. Do not clean the system devices when charging. Always un-plug the charger first before cleaning the device(s). Do no use the device again until it is completely dry. Do not expose the device to direct sunlight and protect it from dirt and moisture. Store the system in a clean, dry place. Do not dispose of the device(s) in a fire. The battery could explode causing injury or death. 15 Electrode The electrode pads are disposable and use an adhesive that will dry after prolonged usage or storage. Pads should be replaced when they lose their adhesive quality, or you sense a change in stimulation sensation. If you’re in doubt about the integrity of the pads, order fresh pads please order online at www.well-life.com.tw, or contact authorized distributor(s). Rechargeable Battery The rechargeable Battery is built-in the device(s). Please do not attempt to disassemble or force open the built-in battery. Batteries have a finite lifetime for 12 months. To maximize battery life, please charge the system every 3 months when not in use. If you find the battery can not be charged effectively, or the fully charged battery can only be used for very short time, please order replacement units online at www.well-life.com.tw, or contact authorized distributor(s). Do not dispose of the device(s) in a fire. The battery could explode causing injury or death. How to Store Your System 1. Store your System at room temperature in a dry place, out of the reach of children. 2. Please store in a low humidity, low temperature environment. 16 TROUBLE SHOOTING Always check the unit and accessories before use to prevent damage and defects; these are some of the simple checks: 1. Make sure the Remote and Receiver(s) have a sufficient charged. 2. Make sure the Remote and Receiver(s) turn on and in 3 meters (9 feet) away from each other, for good quality of receiving distance … If this happens … The Remote is not turning on or Try this solution… Ensure that the remote has been fully charged. I cannot see anything on the screen The power light on the Receiver(s) flashes continuously. Charge the Receiver(s) or it will turn off automatically. The Remote and/or Receiver(s) do not seem to be charging. Ensure the USB Cable is correctly into the Remote/ Receiver(s) and firmly plugged into the AC adaptor and into the electrical socket on the other side. Receiver(s) does not pair with remote ● Make sure the receiver is fully charged, and turned on, away from Remote in 3 meter distance. The remote does not control Receiver(s) well Stimulation causes discomfort ● Try to restart the remote and receiver(s). ● Electrodes lose their adhesive capacity and no longer provide adequate contact with skin. ● Electrodes are worn and must be replaced. ● Change the positing of the electrodes slightly. ● Choose Program that is appropriate to your needs or gives you the greatest pleasure. Stimulation does not produce the usual sensation ● Check that all settings are right and check electrodes are properly positioned. ● Change the positing of the electrodes slightly. 17 TECHNICAL SPECIFICATIONS Channel: Dual , 2 wireless units independent and individually adjustable channels, electrically insulated from one another. Pulse Rate : As pre-programmed, in operation mode. Pulse Width : As pre-programmed, in operation mode. Timer : 5~60 min. selectable. Wave Form : Symmetrical Bi-Phasic square pulse. Max Charge per Pulse : 20.8 micro-coulombs maximum. ** All electrical specifications are ±10% at 500Ω load. Input rating: 5Vdc, 1A Power Source : Remote Control Battery 3.7V /260 mAh Lithium polymer (LiPo) battery. Wireless unit 3.7V /180 mAh Lithium polymer (LiPo) battery. AC Adaptor manufacturer/model: FranMar International Inc. / FRM06-S05-z, 28.1x64.1x42 mm( LxWxH) AC Adaptor I/P: 100-240Vac, 50-60Hz, 0.3-0.15A ; O/P: 5Vdc, 1.2A Weight & Dimension: Remote Control 60 grams (battery included), 156.98x47x15.50 mm Wireless Unit 30 grams (battery included) , 60x60x15.65 mm Operating Conditions: + 50°F (10℃) to +104° (40℃), 40-90% max. Relative humidity Transport and Storage Conditions: +14°F (-10℃) to +140° (60℃), 30-95% max. Relative humidity Operation altitude: 3000m. Operating Atmospheric pressure range: 700~1013 hPa Transport and Storage Atmospheric pressure range: 500~1060 hPa RF Module : Radiations Frequency：2.4GHz Frequency Band：2410~~2450MHz GFSK typical：GFSK (i) There are a number of technical symbols on your system, explained as follows: Remote Label Receiver Label This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, (2) including interference that may cause undesired operation. 18 This symbol means “Serial number “on the back of remote control. This symbol means “Lot number “on the back of wireless unit. This symbols means “ Attention, consult the accompanying documents” Follow instructions for use This symbol means “ Manufacturer “ This symbol means type BF equipment; this device offers protection against electrical shock by standard compliance to leakage currents of electrode pad. This device shall be disposed in accordance with national laws after their useful lives Interference may occur in the vicinity of equipment marked with the following symbol: IP22 Drip proof. Do not immerse power unit in any liquid or spray any liquids directly on power unit. Stand-by. (ii) There is a label on the package explained as: This symbol means “used before”, represent as “YYYY-MM” (for year and month). ELECTROMAGNETIC COMPATIBILITY The device complies with current specifications with regard to electromagnetic compatibility and is suitable for use in all premises, including those designated for private residential purposes. The radio frequency emissions of the device are extremely low and in all probability do not cause any interference with other devices in the proximity. It is recommended that you do not place the device on top of or close to other electronic devices. Should you notice any interference with other electrical devices, move the device or connect it to a different socket. Radio equipment may affect the operation of this device. 19 Recommended separation distances between portable and mobile RF communications equipment and the ME equipment The Wireless Electrical Stimulator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Wireless Electrical Stimulator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Wireless Electrical Stimulator as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter Rated maximum output power of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz 0.01 0.1 0.12 0.37 0.12 0.37 0.23 0.74 10 1.17 3.7 1.17 3.7 2.33 7.37 100 11.67 11.67 23.33 Declaration – electromagnetic emissions and immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING and are specified for use only in a shielded location The Wireless Electrical Stimulator declaration – electromagnetic immunity The Wireless Electrical Stimulator system is intended for use in the electromagnetic environment specified below. The customer or the user of the Wireless Electrical Stimulator system should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment ‐ guidance Conducted RF 3 Vrms IEC 61000‐4‐6 150 kHz to 80 MHz Radiated RF 3 V/m IEC 61000‐4‐3 80 MHz to 2.5 GHz 3V Portable and mobile RF communications equipment should be used no closer to any part of the EQUIPMENT or SYSTEM 3V/m including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitte Interference may occur in the vicinity of equipment marked with the following symbol. 20 Declaration – electromagnetic immunity The Wireless Electrical Stimulator system is intended for use in the electromagnetic environment specified below. The customer or the user of the Wireless Electrical Stimulator system should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment ‐ guidance Electrostatic Floors should be wood, concrete or ceramic ±6 kV contact ±8 kV air discharge (ESD) IEC 61000‐4‐2 Electrical fast transient/burst IEC 61000‐4‐4 ±2 kV for power supply lines ±1 kV for input/output lines ±1 kV differential mode ±2 kV common mode Surge IEC 61000‐4‐5 Voltage dips, short ＜5 % UT (＞95 % dip in UT) for 0.5 cycle interruptions and 40 % UT (60 % dip in UT) for 5 cycles voltage ±6 kV contact ±8 kV air tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a ±2 kV for power supply lines ±1 kV differential mode ＜5 % UT (＞95 % dip in UT) for 0.5 cycle typical commercial or hospital environment. 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. 40 % UT If the user of the EQUIPMENT or SYSTEM (60 % dip in UT) for 5 cycles requires continued operation during power variations on 70 % UT 70 % UT mains interruptions, it is recommended that power supply (30 % dip in UT) for 25 cycles ＜5 % UT (＞95 % dip in UT) for 5 sec (30 % dip in UT) for 25 cycles ＜5 % UT (＞95 % dip in UT) for 5 sec the EQUIPMENT or SYSTEM be powered from input lines IEC 61000‐4‐11 Power frequency (50/60 Hz) magnetic field IEC 61000‐4‐8 an uninterruptible power supply or a battery. Power frequency magnetic fields should be at 3 A/m 3 A/m levels characteristic of a typical location in a typical commercial or hospital environment. Declaration – electromagnetic emissions The Wireless Electrical Stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of the Wireless Electrical Stimulator should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment ‐ guidance The Wireless Electrical Stimulator uses RF energy only for its internal function. Therefore, CE emissions its RF emissions are very low and are not likely to cause any interference in nearby Group 1 CISPR11 electronic equipment. RE emissions The Wireless Electrical Stimulator is suitable for use in all establishments, including Class B CISPR11 domestic establishments and those directly connected to the public low‐voltage power Harmonic emissions IEC 61000‐3‐2 Voltage fluctuations/ Flicker emissions IEC 61000‐3‐3 Class A supply network that supplies buildings used for domestic purposes. Complies 21 FCC Information The Federal Communication Commission Radio Frequency Interference Statement includes the following paragraph: The equipment has been tested and found to comply with the limits for a Class B Digital Device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instruction, may cause harmful interference to radio communication. However, there is no grantee that interference will not occur in a particular installation. If this equipment dose cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on , the user is encouraged to try to correct the interference by one or more of the following measures: --Reorient or relocate the receiving antenna. --Increase the separation between the equipment and receiver. --Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. --Consult the dealer or an experienced radio/TV technician for help. The user should not modify or change this equipment without written approval from Well-Life Healthcare Limited . Modification could void authority to use this equipment. ▲Notice : The changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. ▲IMPORTANT NOTE: To comply with the FCC RF exposure compliance requirements, no change to the antenna or the device is permitted. Any change to the antenna or the device could result in the device exceeding the RF exposure requirements and void user’s authority to operate the device. 22 Warranty This Well-Life Stimulator carries a one-year warranty from the date of purchase. Product Service Life: Three (3) years. The warranty applies to the main device and necessary parts and labor relating thereto. Consumable items like : batteries, electrodes, and other accessories are warranted to be free from defects in workmanship and materials at the time of delivery. The warranty does not apply to damage resulting from failure to follow the operating instructions, accidents, abuse, alterations or disassembly by unauthorized individuals. The distributors reserve the right to replace or repair the unit at their discretion. Well-Life Healthcare Ltd. 1Fl. No.16 , Lane 454. Jungjeng Road, Yunghe District, New Taipei City 23455, Taiwan www.well-life.com.tw SANICO Srl Via Turati,7, 20121 Milano 23
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