Dongdixin Technology LT5018C Wireless 3-in-1 Pain Relief Device User Manual

Shenzhen Dongdixin Technology Co.,Ltd. Wireless 3-in-1 Pain Relief Device

User Manual

Wireless 3-in-1 Pain Relief Device User ManualClinicallyProvenLT5018C
This manual is valid for the Wireless 3-in-1 Pain Relief Device The device complies with all the standards relating to Class ll electrical medical devices andto devices which use electrical stimulation for use at home.All Rights Reserved.Rev.V1.0 © 2017Conformity to safety standardsShenzhen Dongdixin Technology Co., Ltd. declares that the device complies with followingnormative documents:IEC60601-1, IEC60601-1-2, I EC60601-2-10, IEC62366, IEC60601-1-11ISO10993-5, ISO10993-10, ISO10993-1, ISO14971
3TABLE OF CONTENSIntroduction ...............................................................................................................................4Important safety precautions and warnings .................................................................................5How TENS works for pain relief.................................................................................................12How EMS works for muscle stimulation.....................................................................................13Package contents.....................................................................................................................14Know your device.....................................................................................................................15Charging...................................................................................................................................18Easy steps to get started with your therapy with electrode pads..................................................19Cleaning and storage................................................................................................................26Specications...........................................................................................................................28How to control and reduce your pain.........................................................................................30Troubleshooting .......................................................................................................................32Product/Battery disposal...........................................................................................................34Glossary of symbols..................................................................................................................34Important information regarding electromagnetic compatibility (EMC) .......................................35FCC Compliance information....................................................................................................... 42Warranty..................................................................................................................................43
4■ EMS: The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. It should be applied to normal, healthy, dry and clean skin of adult patients. It is design to be used at home. INTRODUCTIONThank you for purchasing the Wireless 3-in-1 Pain Relief Device for your pain relief solution. In order to use the stimulator safely, read the complete manual carefully before using the device for the rst time.Keep this instruction manual in a convenient place or store with the device for future reference.Indications for use:■ TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. No.Standard Parts:DESCRIPTION QUANTITYA LT5018C 1PCB Electrode pad (2 in. x 2 in) 4PCSC Instruction manual 1PCD Micro-USB cable 1PCE Remote control 1PCThe package contains the following components:
5SAFETY SYMBOLS USED IN THIS MANUAL IMPORTANT SAFETY PRECAUTIONS AND WARNINGSIt is important that you read all the warning and precautions included in this manual because they are intended to keep you safe, prevent injury and avoid a situation that could result in damage to the device.DANGERDANGERIndicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.WARNINGIndicates a potentially hazardous situation which, if not avoided, could result in serious injury and equipment damage.■ Internally transplanted electronic medical devices, such as a pacemaker.■ Electronic life support equipment, such as respirators. ■ Electronic medical devices attached to the body, such as electrocardiographs.CAUTIONIndicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the device or other property.This stimulator must not be used in combination with the following medical devices:
6DO NOT USE THIS DEVICE DURING THESE ACTIVITIESDO NOT USE ON THESE INDIVIDUALS■ Pregnant women, because the safety of electrical stimulation during pregnancy has not been established.■ Children or infants, because the device has not been evaluated for pediatric use.■ Persons incapable of expressing their thoughts or intentions.■ When in the bath or shower;■ While sleeping;■ While driving, operating machinery, or during any activity in which electrical stimulation can put you at risk for injury.WARNING■ Consult with your physician before using this device, because the device may cause lethal rhythm disturbances in certain susceptible individuals.■ On open wounds or rashes, or over swollen, red, infected, or inamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins); or on top of, or in proximity to, cancerous lesions.■ Over areas of skin that lack normal sensation.■ Stimulation should not take place while the user is connected to high-frequency surgical equipment, it may cause burn injuries on the skin under the electrodes, as well as problems with the stimulator.■ Do not use the stimulator in the vicinity of shortwave or microwave therapy equipment, since this may affect the output power of the stimulator.DO NOT USE THIS DEVICE UNDER THESE CONDITIONS:
PAIN MANAGEMENT WARNINGS■ If you have had medical or physical treatment for your pain, consult with your physician before using this device.■ If your pain does not improve, becomes seriously chronic or severe, or continues for more than ve days, stop using the device and consult with your physician.■ The mere existence of pain functions as a very important warning telling us that something is wrong. Therefore, if you suffer from any serious illness, consult your physician in order to conrm that it is advisable for you to use this TENS Stimulator.7WARNINGS AND PRECAUTIONS REGARDING THE PADS ■ Apply pads to normal, healthy, dry, clean skin (of adult patients) because it may otherwise disrupt the healing process.■ If you experience any skin irritation or redness after a session, do not continue stimulation in that area of the skin.■ Pads should not touch each other when placed onto your skin.■ Pads must be placed at least 2 in apart.■ Both sides of the thorax simultaneously or across your chest because the introduction of electrical current may cause rhythm disturbances which could be lethal. NEVER APPLY THE PADS TO■ The head or any area of the face.■ Never apply the pads to the side of the neck (on the carotid sinus) or any area of the throat (front of the neck) because this could cause severe muscle spasms resulting in closure of the airway, difculty in breathing, or adverse effects on heart rhythm or blood pressure.WARNINGDANGER
■ Do not bend or fold because the pad may not function properly. Place the pads onto the plastic lm and then store into the sealed package when not in use.■ Do not apply ointment or any solvent to the pads or to your skin because it will disrupt the pads from functioning properly.■ The pads are already pre-gelled and will adhere to your skin.■ To avoid damage to the adhesive surface of the pads, put the pads only on the skin or on the plastic lm provided.■ Always place the electrodes in accordance with illustrations provided (Refer to the Pad Placement illustrations).■ Make sure the components are connected well and the pads are xed on the part of the body you wish to treat or the therapy may not be effective.8CAUTION DO NOT USE YOUR PADS THIS WAY ■ Pads should not touch each other when placed onto your skin. Pads should be at least 2 in apart.■ Do not place on your spine or backbone. WARNING■ If you have suspected or diagnosed heart disease, you should follow precautions recommended by your physician.■ If you have suspected or diagnosed epilepsy, you should follow precautions recommended by your physician.■ Consult your physician if you have a tendency to bleed internally, such as following an injury or fracture.■ This stimulation should not be applied over the menstruating or pregnant uterus.
■ Pad should not touch any metal object, such as a belt buckle or necklace.■ Do not share pads with another person. This may cause a skin irritation or infection. Pads are intended for use by one person.■ Always turn the power off before removing or changing the pad location.■ Do not leave pads attached to the skin after treatment.■ If the stimulator is not functioning properly or you feel discomfort, immediately stop using the device.■ Do not use for any other purpose except for what it is intended for.■ Do not use the device while wearing electronic devices such as watches as this may damage the device.■ Dispose of the device, batteries, and components according to applicable legal regulations. Unlawful disposal may cause environmental pollution.■ The size, shape and type of pads may affect the safety and effectiveness of electrical stimulation.■ The electrical performance characteristics of pads may affect the safety and effectiveness of electrical stimulation.■ Using pads that are too small or incorrectly applied, could result in discomfort or skin burns.9CAUTION WHILE USING THE STIMULATORCAUTION:■ The user is the intended operator.■ The long-term effects of electrical stimulation are unknown.■ Apply stimulation to only normal, intact, clean, dry, and healthy skin.■ TENS is not effective in treating the original source or cause of the pain, including headache.GENERAL PRECAUTIONSCAUTION:
10■ TENS is not a substitute for pain medications and other pain management therapies.■ TENS devices do not cure disease or injuries.■ TENS is a symptomatic treatment and, as such, suppresses the sensation of pain that would otherwise serve as a protective mechanism. ■ Keep unit away from young children. The unit contains small pieces that may be swallowed. Contact your physician immediately if ingested. ■ Use this device only with the electrodes and Micro-USB cable recommended by the manufacturer. ■ Keep unit out of the reach of young children. The cable can cause strangulation.■ Do not use the device if it is closer than 12 inches (30.5cm) to wireless communication equipment, such as wireless home network routers, cell phones, cordless phones and their base stations, and walkie-talkies. The electromagnetic interference of this wireless communication equipment may prevent the device from operating properly.■ If you have any problems with this device, such as setting up, maintaining or using, please contact Carex Health Brands. ■ You may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium (gel).■ Consult with your physician prior to using the device after a recent surgical procedure, because stimulation may disrupt the healing process.■ This stimulation should not be applied over areas of skin that lack normal sensation.CAUTION:
11 Possible Adverse Reactions■ Do not use to treat one region for extended periods of time (more than 30 minutes a session, up to 3 times/day) or muscles in that region may become exhausted and sore.■ You may experience skin irritation and burns beneath the stimulation electrodes applied to your skin.■ You should stop using the device and consult with your physician if you experience adverse reactions from the device.CAUTION:
12HOW TENS WORKS FOR PAIN RELIEFThe Wireless 3-in-1 Pain Relief Device is a single output channel TENS machine and highly effective in temporarily relieving pain. TENS therapy is now regularly recommended by doctors, physiotherapists and pharmacists throughout the world. Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain. TENS uses tiny electrical impulses sent through the skin to nerves to modify your pain perception. TENS does not cure any physiological problem; it only helps control the pain. TENS does not work for everyone; however, in most patients it is effective in temporarily reducing or eliminating the pain, allowing for a return to normal activity.Scientific theory suggests that electrical stimulation therapy may work in several ways:■ The gentle electrical pulses move through the skin to nearby nerves to block or shut out the pain message from ever reaching the brain from the source of the pain.■ The gentle electrical pulses increase the production of the body’s natural pain killer, such as endorphins.What is it? How TENS works?
13HOW EMS WORKS FOR MUSCLE STIMULATIONEMS works by sending electronic pulses to the muscle needing treatment; this causes the muscle to exercise passively. It is a product derived from the square waveform (ladder‐shaped). Through the square wave pattern it is able to work directly on muscle motor neurons. This device has low frequency and this in conjunction with the square wave pattern allows direct work on muscle groupings. The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. Normal muscular activity is controlled by the central and peripheral nervous systems, which transmit electrical signals to the muscles. EMS works similarly but uses an external source (the stimulator) with electrodes attached to the skin for transmitting electrical impulses into the body. The impulses stimulate the nerves to send signals to a specifically targeted muscle, which reacts by contracting, just as it does with normal muscular activity.How MASSAGE works? The massage stimulation program is a type of low level EMS used to loosen tight muscles. Its main function is to mimic manual massage to promote relaxation and reduce muscle tension.The EMS units send comfortable impulses through the skin that stimulate the nerves in the treatment area. When the muscle receives this signal it contracts as if the brain has sent the signal itself. As the signal strength increases, the muscle flexes as in physical exercise. Then when the pulse ceases, the muscle relaxes and the cycle is repeated. What is it?How EMS works?
14LT5018C Unit Remote ControllerPACKAGE CONTENTSElectrode Pads (2 in. x 2 in.) Instruction ManualAAA batteries Micro-USB cableQuick Start Guide Wireless 3-in-1 Pain Relief Device User ManualClinicallyProvenModel ACRL-9100Model ACRL-9100QUICK START GUIDEClinicallyPr ovenEnsure that the Bluetooth (4.0) connection is activated on your smartphone or tablet. Wireless 3-in-1 Pain Relief Device Apply pads to normal, heal thy, clean and dry skin of adult pat ients because it may otherwise disr upt the healing process.If you experi ence any skin irritation or redness after a session, do not continue stimulation i n that area of the skin. KNOW YOUR DEVICEPower on/off buttonTENSEMSMASSAGERECHARGEABLE LITHIUM BATTARYMASSAGE3IN114PROGRAMSWhen you open the Wireless 3-in1 app in your mobile phone, the app asks you to turn on Bluetooth. Please accept.- For iOS: Press settings to turn on Bluetooth. - For Android: Pr ess "allow" to turn on Bluet ooth.2PLACE TH E GEL PA DS ON THE S KINCONNECT THE GEL PADSTO THE D EVICE1TURN ON THE BLUETOOTHEach gel pad is pre-fixed with a stud to connect to the back of the device, and is protected by a transparent film. Attach the gel padsto the back of the device, pressing them in place. 3Clip excess hairfrom the area to betreated. Wash wit hsoap and water,and dry completel y. Remove theprotective filmlayer and applythe gel pad to th eskin. Press firml yto ensure adhesio n.See the Recommend ed Gel Pad Positions on reverse page.4TURN ON THE ACRL -9100 UNIT AND START A SESSION THROUGH THE USE OF THE DEVICE A PPLICATI ON Press the on/off button so that the appliance is put on standby mode (Continuous green light : Standby mode, ready for the session). The App will dete ct the device when it is switched on. In case of inactivity for more than 5 min, the device switches off. Simply press the on/off button again to reenter standby m ode. Press the name of the devic e on your app screen to enter m ain menu.ACRL-9100---DisconnectedSELECT THE AREA TO BE TR EATEDTo start a new se ssion, select a program (TENS, EMS or Mas sage) and using the labels on the fro nt and back of the body image select the area you wish to treat. 5ACRL-9100ACRL-9100ESTIMATE THE INTENSITY OF PAIN (IN TENS MODE)On a scale of 1 t o 10, evaluate the intensity of the pain. For no pain press 0, for extremely intense pain pres s 10.6SELECT A ND START A SESSION.Starting a sessio n : Click on “+” button to begin increasi ng intensity. When your session is complete, estimate your satisfaction leve l. The session will be recorded in the H istory folder of the app.To turn off, press the power button on the app or device. Remove the electrodes from t he skin. Remove the device from the electrodes. If the device is idle for more than 5 minutes, it will turn off.Make sure the dev ice is turned off before rem oving the electrodes.7
KNOW YOUR DEVICEFeatures■ Channels: One channel■ Treatment modes TENS: 6 programs EMS: 5 programs MASSAGE: 3 programs■ Output Amplitude: 0-60mA (1000 Ω Load)■ Waveform type: Symmetrical Biphasic square pulse■ Control platform APP control (ios or Android) and Remote controlFront and Rear Panel1231. On/off button [ ]: Press this button to turn on the device or turn off the device.■ Green Flashing indicator light: The device hasn't connected with APP or the Remote Controller;■ Continuous green: The device is in standby mode;■ Continuous Orange: The device is in treatment mode;■ Orange ashing: The device is in paused mode;2. Indicator light when charging:■ Continuous orange: The battery is charging;■ Continuous green: The battery is fully charged.3. Device charging port:■ Connect the Micro-USB cable and the adaptor to the device port to charge;15
16Power ON/OFF button Mode select (TENS/EMS/MASSAGE)LCD DISPLAYIntensity increaseTreatment proqramselect: Neck/Shoulder/Arm/LBack/Joint/LegTap/Knead/RubIntensity decrease
LCD Display17Treatment time iconTreatment time displayTreatment program Intensity icon Low battry icon Lock IconTreatment modeTreatment intensity display
CHARGINGNOTES:18 ■ Only use the Micro-USB cable which is provided by the manufacturer.■ Device must be charged prior to rst use. Typically it takes 2 hours to charge the device. A full charge allows a battery life of about 4 hours continuously when functioning in normal (ambient temperature) conditions. ■ Please charge the device fully before beginning each session. If the charge is not complete at the beginning of a program, the battery may become depleted before the end of the session. You cannot use the device while it is charging. ■ If batteries leak and come into contact with the skin or eyes, wash immediately with copious amounts of water.■ Dispose of the used batteries safely according to the local regulations.■ The life of a rechargeable battery depends on the number of recharging/rundown cycles it undergoes and how these cycles are performed. The service life of rechargeable battery is more than 300 recharging/rundown cycles. We provide the following suggestions to extend the life of the battery:■ Whenever the device is not used frequently, we recommend recharging the battery once a month.Insert the Micro-USB plug of the Micro-USB cable into the Micro-USB charging port of the LT5018C device, and then connect to the Standard USB plug of the Micro-USB cable to the appropriate power supply device which could output 5V d.c. , 300mA.When the battery light goes from continuous orange (which means that the battery is being charged) to a continuous green (the battery is full), remove the micro-USB plug from the micro-USB socket of the device.LT5018CWARNING:
STEP 4 Using the APP to control main device:Step 1 Downloading the APP Step 2– Cleaning of skin Step 4–Placing the gel pads Download the application to your smart phone :■ By the Appstore or Google Play■ Then search ‘LT5018C’, and click the Smart Pain Reliever LT5018C icon.The app operates on ios and Android platforms (At least ios 8.0, Android 5.0)LT5018C Step 3– Preparation of the ACRL-9100 unit Each gel pad is pre-xed with a male snap to connect to the back of the device, and is protected by a transparent lm. Press the male snap of the gel pad to the female snap of the device asshown in the picture on the right: Clip excess hair from the treatment area and remove any jewelry that may come in contact with the stimulation of the device. Wash area with soap and water, and dry completely.EASY STEPS TO GET STARTED WITH YOUR THERAPY WITH ELECTRODE PADS19Place electrodes on clean, dry and healthy skin at least 2 in. apart and do not let them touch. Make sure there is a linear path between the two electrodes. (See the pages 22-23).Note: Replace the electrodes when they are damaged or dirty, when they have lost their adhesive power or when stimulation becomes uncomfortable, i.e. when you experience an unpleasant stinging or biting sensation.
20Note: Always connect the device before you place the electrodes on the skin.Note: DO NOT place the electrodes on top of each other or so close to each other that they touch each other.Note: It is possible that you may need external assistance for placing the electrodes in certain areas.Replace the electrodes if:■ they are damaged or torn.■ they are past the use-by date indicated on the re-sealable bag.■ they have lost their adhesive power. Never use plaster or tape to attach them to your skin.■ stimulation feels less strong.■ when stimulation is uncomfortable, i.e. when you experience an unpleasant stinging or biting sensation.Note: Always replace the electrodes with electrodes recommended for this device by the manufacturer. WARNING: Make sure the device is turned off before applying electrodes.WARNING: Place the electrode pads according to the electrode Pad placement illustrations, on pages 22-23.WARNING:
21Pad Placement illustrations Position of the electrodes-TENS programs:NECK / CERVICAL PAINAttach both pads on the neck.(DO NOT place on the back ofthe carotid artery, throat or thefront of the neck.)SHOULDER PAINAttach one pad in front and one in back of the muscle.CARPAL TUNNEL /HAND PAINAttach both pads on the hand where you feel pain.LOWER BACKAttach both pads on the lower back with the backbone in the center. DO NOT place on the backbone or spine. UPPER ARM PAINAttach both pads on eitherside of the region where youfeel pain. ELBOW PAINAttach both pads on either sideof the joint with the pain.
22KNEE / JOINT PAINAttach both pads above the knee or above and below the joint with pain.CALF PAINAttach both pads on the calf/leg where you feel pain. DO NOT place electrode pads simultaneously to the calves of both legs.ANKLE / FOOT PAINAttach pads per the illustration on the left for pain on the outside of your ankle/foot. Attach the pads per the illustration on the right for pain on the inside of your ankle/foot. DO NOT place electrode pads simultaneously to the soles of both feet. Treat one at a time.
23Step 5–Starting a session through the use of the device application■ Ensure that the Bluetooth (4.0) connection is activated on your smartphone or tablet. Turn on the APP. ■ Press the on/off button on the device so that the device is in standby mode (Continuous green light : Standby mode, ready for the session). The App detects the device which is switched on. In case of inactivity for more than 5 min, the device switches off. Press the on/off button again to begin a session.Step 6–Select the area to be treatedIn the case of a new session, it is essential to select a treatment area and a program. 0ACRL-9100Step 7–Estimate the intensity of pain you are currently experiencing in the area to be treated (in TENS mode)On a scale of 1 to 10, evaluate the intensity of the pain. For no pain press 0, for extremely intense pain press 10.ACRL-9100Step 8–Select and start a session■ Starting a session : Click“+” button to begin treatment■ After session is complete, estimate your satisfaction level, the session is then recorded in the history
24 Using the Remote control to control the main device: ■ To turn off the device, press the “On/Off” button.■ Remove the electrodes from the skin. Detach from the edges.■ Remove the device from the electrodes. If you forget the device for more than 5 minutes, it turns off. If the device is frequently used during the day, it is advisable to charge it before starting a new session.Step1–inserting batteries1. Remove the battery cover on the back of the device 2. Insert 2xAAA batteries. Make sure the positive + and negative – signs correspond with the markings in the device when inserting batteries. Reinstall the battery cover .Notes:■ Please use 2×AAA batteries in this remote control.■ Remove the batteries if the device is not in use for long periods of time.■ Do not mix old and new batteries or different types of batteries.■ Remove exhausted batteries from the remote control.Step 2– Cleaning of skinPlease refer to pg.19Step 3– Preparation of the ACRL-9100 unit Please refer to pg.19 Step 4–Placing the gel pads Please refer to pg.19Step 9 - Following completion of sessionCAUTION:■ Batteries must be handled by an adult. Keep batteries out of the reach of children.
25 STEP 5-Operating the remote controlled device.NOTE: You cannot turn the LT5018C unit on by pressing the remote control. You must do so by pressing the on/off button on the device itself. ■ A steady green light indicator light will turn on to let you know the unit is on.■ Using the remote control press the Mode button to switch treatment mode in standby mode.■ Using the remote control press the Program button to select treatment part in standby mode.■ Using the remote control when the unit is press the ▲ button to increase or the ▼ button to decrease the intensity.NOTE: There are 60 levels of intensity. STEP 6 - Turn off the deviceYou can turn device off in the following ways:■ The device will turn off automatically after 30 minutes treatment time.■ Press the power button continuously until the LED light turns off.■ Turn the remote controlled device off by pressing the On/Off button on the remote control■ To turn off the device, press the “On/Off” button.■ Remove the electrodes from the skin. Detach from the edges.■ Remove the device from the electrodes. If you forget the device for more than 5 minutes, it turns off. If the device is frequently used during the day, it is advisable to charge it before starting a new session.Step 7 - Following completion of session
26 CLEANING AND STORAGECleaning the main device and the remote control1) Turn unit off. Remove USB if device has been charging. 2) Clean the device after use with a soft, slightly moistened cloth and wipe gently.■ Do not use chemicals (like thinner, benzene).■ Do not let water get into the internal area.Note:■ This device and accessories does not require sterilization.Cleaning the electrode pads1) Turn the power off2) Remove pads from device.3) Wash the pads when the adhesive surface becomes dirty and/or the pads are difcult to attach.■ Wash the pad softly with your ngertips under slow running cold water for several seconds (do not use a sponge/cloth/sharp object like a nail on adhesive side, do not use detergents, chemicals or soap).4) Dry the pads and let the adhesive surface air-dry completely (do not wipe with a tissue paper or cloth).CAUTION:■ The life of pads may vary by the frequency of washing, skin condition, and storage state.■ If the pad no longer sticks to your skin or the pad is broken, immediately discontinue use and obtain replacement pads as recommended by the manufacturer.■ Before applying the self-adhesive electrodes, it is recommended to wash and degrease the skin, and then dry it. ■ DO NOT turn on the device when the electrodes are not positioned on the body. ■ Never remove the self-adhesive electrodes from the skin while the device is still turned on.
27CAUTION:■ If replacement electrodes are necessary, use only electrodes that are the same size (50*50mm) as the electrodes provided with the LT5018C. ■ Use of electrodes that are larger may reduce the effect of the stimulation. Use of electrodes that are much smaller than the electrodes provided with the LT5018C may increase the chance of skin irritation or electrode burns occurring under the electrodes.■ Always use electrodes that have been cleared for marketing in the US by the FDA.■ Always clean the electrodes after your treatment every time. Storing the electrode pads Place clean, dry pads on the plastic lm and then store inthe sealed package between uses. Storing the unit■ Place the unit, electrodes and manual back in package. Store the box in a dry place, 14°F~131°F （-10°C~55°C); 10% ~90% relative humidity.■ KEEP DEVICE AND ALL ACCESSORIES OUT OF REACH OF CHILDREN.When not in use for a long period, remove the batteries before storage, to avoid liquid discharge from batteries.
28SPECIFICATIONS■ Power Sources: 3.7V Li-ion (remote control : DC 3.0V 2 x AAA Batteries )■ Power Supply:5V DC, 300mA■ Frequency: 2Hz~150Hz■ Pulse Width: 50us~370us■ Wave form: Biphasic square wave ■ Output Voltage: 0~60V (at 1000 ohm load)■ Output Intensity Level: 0~60 levels■ Operating Conditions: 5℃~40℃; 30%RH~75%RH; 700hPa ~1060hPa■ Storage and transport conditions (main device): 14°F~131°F (-10°C~55°C); 10%RH~90%RH; 700hPa ~1060hPa■ Size: 14.17’’(L)x2.32’’(W) x0.45’’(H) (main device) 4.53’’(L)x2.09’’(W) x0.98’’(H) (Remote control) ■ Weight: 36g (main device) 65g (Remote control)■ Service life of the device: 2 years■ Service life of electrode pads: 30 times■ Applied part: Electrode■ Size of electrode: 2 in. x 2 in.■ IP classication system: IP22■ Maximum separation distance: 10m (In the opened environment)■ The recommended separation distance: 3m.
29Description of the Wireless Functions and Technology:■ RF Frequency 2.4GHZ-2.48GHZ■ Channel Bandwidth 2 M H z (-20db)■ Operation Voltage DC3.7V■ Types of spread spectrum FHSS■ Modulation type GFSK■ Number of channel 40■ Chanel spacing 2 MHz■ Channel frequency 0-39 Channel 2.402-2.480GHZ■ Dwell time (if FHSS) 400ms■ Hopping rate (if FHSS) 1600HZ■ Antenna gain 0dBi■ Bluetooth version V1.0■ Maximum Output Powers 0dBmThe LT5018C device uses the one-on-one connection of BLE4.0, and our device as a peripheral, responds to the APP’s connection request passively, establishing a one-on-one connection with the APP. After the LT5018C device connects to the APP, the device will not be connected to other wireless devices or controlled. After the APP connects to the peripheral device, the APP will send the command, and when the LT5018C device ensures this command is right, it will open the control command, then you can control the LT5018C device. Otherwise, the APP can’t control the LT5018C device.
When should the device be used? HOW TO CONTROL AND REDUCE YOUR PAIN30Use as soon as your pain begins. Start with one session (unit automatically turns off at 30 minutes). If you get to your pain early, it may prevent the pain from becoming worse, or even chronic. It’s better for you to get it under control sooner so that it does not reach a high pain threshold where it limits your daily activities.How long should you use the device?Start with one 30 minute session. Always turn unit off with pads still on. Rate your pain to check your progress, 1 low to 60 high. Intensity is based upon your level of comfort. Begin the rst session with a low intensity and a short duration while learning how to operate.Stop therapy session if pain has reduced or stopped. If your pain does not improve and you become sore from over-use, refrain from treating those areas for 2 days. If this issue reoccurs, reduce the treatment time and intensity settings for future treatment.Setting the intensityIntensity is based upon your level of comfort. Begin the rst session with a low intensity and a short duration while learning how to operate. You should therefore take care to work with maximum intensities, i.e., always at the limit of what you can support. Do not exceed your comfort level.
31Recommended treatment session as following: When to stop using the device?■ If you experienced an adverse reaction (skin irritation/redness/burns, headache or other painful sensation, or if you feel any unusual discomfort).■ If your pain does not improve, becomes seriously chronic and severe, or continues for more than ve days.NOTE:If you feel pain, dizziness, discomfort or nausea, discontinue use of device and call your physician or medical practitioner.What type of pain is it best for?This therapy works best on acute pain because it is localized. Acute pain is pain in one area for less than 3 months. If you have chronic pain, you may have pain in more than one area and for longer than 6 months. Chronic pain may be compounded by other issues that this device cannot address.Remember this device does not cure your pain or the original cause of the pain. It provides temporary relief or reduction of pain so that you can control your life and activities better.CAUTION:You may use the device for 30 minutes a day. You may need to use it for longer (maximum 3 times per day and maximum 90 minutes in total)depending on the level of your pain.
The unit will notpower on Are the batteries exhausted? Replace the batteries.Are the batteries installed correctly? Insert the batteries observing polarity.Stimulation weak or cannot feel any stimulationElectrodes are dried out or dirty. Replace with new electrodes.Electrodes do not stick to skin well. Replace with new electrodes.Stimulation is uncomfortableIntensity is too high Decrease intensity.Electrodes are too close together. Reposition electrodes to be at least 2 inches apart Electrode active area size is too small. Replace electrodes with ones that no less than 2 in Is the device being operated according to the manual?Please check the manual before use.32TROUBLESHOOTINGPROBLEM POSSIBLE CAUSES POSSIBLE SOLUTION
33PROBLEM POSSIBLE CAUSES POSSIBLE SOLUTION Stimulation is ineffective.Improper electrode placement. Reposition electrode.Unknown Contact clinician.The skin becomes red and/or you feel a stabbing painUsing electrodes on the same site every time. Reposition the electrodes. If at any time you feel pain or discomfort, stop use immediately.Electrodes are not adhered to the skin properly. Ensure the electrodes are securely adhered to the skin.The electrodes are dirty. Clean the electrodes according to description in this manual or replace with new electrodes.The surface of the electrode is scratched. Replace with new electrodes.Output current stops during therapyThe electrodes come off the skin. Turn off the device and place the electrodes on again, or replace with new electrodes.The batteries’ power has been exhausted. Replace with new batteries.
34PRODUCT/BATTERY DISPOSALGLOSSARY OF SYMBOLSUsed fully discharged batteries must be disposed of in a specially labeled collection container, at toxic waste collection points or through an electrical retailer. You are under legal obligation to dispose of batteries correctly. Please dispose of the device in accordance with the legal obligation.Electrical devices are recyclable material and should not be disposed of with household waste after their useful life! Help us to protect the environment and save resources and take this device to the appropriate collection points. Please contact the organization which is responsible for waste disposal in your area if you have any questions.Type BF Applied PartRefer to instruction manual The rst number 2: Protected against solid foreign objects of 12,5 mm Ф and greater. The second number: Protected against vertically falling water drops when enclosure tilted up to 15o. Vertically falling drops shall have no harmful effects when the enclosure is tilted at any angle up to 15o on either side of the vertical.IP22SNThis symbol means that this device emits non-ionizing radiation. Alldevices with RF transmitters or that use RF electromagnetic energymust have a label with this symbol.Represent manufacture date and serial number.
35 IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY (EMC)1) 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. 2) Do not use a mobile phone or other devices that emit electromagnetic elds, near the unit. This may result in incorrect operation of the unit. 3) This unit has been thoroughly tested and inspected to assure proper performance and operation. 4) 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 conguration in which it will be used. Guidance and manufacture’s declaration – electromagnetic emission ComplianceThe LT5018C is intended for use in the electromagnetic environment specied below. The user of the LT5018C should assure that it is used in such an environment.Emission test Electromagnetic environment – guidanceThe LT5018C use RF energy only for its internalfunction. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.RF emissions CISPR 11Group 1CAUTION:
36 Harmonic emissionsIEC 61000-3-2Voltage uctuations/icker emissionsIEC 61000-3-3The LT5018C is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply networkthat supplies buildings used for domestic purposes.RF emission CISPR 11 Class B Class A CompliesGuidance and manufacture’s declaration – electromagnetic immunityThe ACRL-9100 is intended for use in the electromagnetic environment specied below. The user of ACRL-9100 should assure that it is used in such an environment.Electromagnetic environment - guidanceElectrostatic discharge (ESD)IEC 61000-4-2±6 kV contact±8 kV air±8 kV contact±15 kV airFloors should be wood, concrete or ceramic tile. If oor are covered with synthetic material, the relative humidity should be at least 30%. Immunity test IEC 60601 test level Compliance level
37 Electrical fast transient/burstIEC 61000-4-4SurgeIEC 61000-4-5Voltage dips, short interruptions and voltage variationson power supplyinput linesIEC 61000-4-11Power frequency (50Hz/60Hz) magnetic eld IEC 61000-4-8<5% UT (>95% dip in UT) for 0.5 cycle40% UT (60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles<5% UT (>95% dip in UT) for 5 sec<5% UT (>95% dip in UT) for 0.5 cycle40% UT(60% dip in UT) for 5 cycles70% UT(30% dip in UT) for 25 cycles<5% UT (>95% dip in UT) for 5 secMains power quality should bethat of a typical commercialor 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. If the user of the ACRL-9100 requires continued operation during power mains interruptions, it is recommended that the ACRL-9100 be powered from an uninterruptible power supply or a battery.Power frequency magnetic eldsshould be at levels characteristic of a typical location in a typical commercial or hospital environment.±2 kV for power supply lines ±1 kV forinput/output lines ±2kV for power supply lines ± 1 kV line(s) to line(s) ± 2 kV line(s) to earth ±1 kV differentialmode 3 A/m 30 A/mNOTE UTis the a.c. mains voltage prior to application of the test level.
38Guidance and manufacture’s declaration – electromagnetic immunityThe LT5018C is intended for use in the electromagnetic environment specied below. The user of the LT5018C should assure that it is used in such an environment.Immunity testConducted RFIEC 61000-4-6Radiated RFIEC 61000-4-33 Vrms150 kHz to 80 MHz3 V/m80 MHz to 2.6 GHz3 V RMS outside theISM band, 6 V RMS in the ISM and amateur radio bands10 V/mPortable and mobile RF communications equipment should be used no closer to any part of the LT5018C, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distanceIEC 60601 test level Compliance level Electromagnetic environment - guidance
39NOTE 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 reection from structures, objects and people.Where P is the maximum output powerrating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommendedseparation distance in metres (m).Field strengths from xed 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:
40a Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld 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 re-orienting or relocating the ACRL-9100b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.The LT5018C is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the LT5018C can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LT5018C as recommended below, according to the maximum output power of the communications equipment.Recommended separation distances between portable and mobile RF communications equipment and the LT5018C
41d= 1.2 d = 1.2 d = 2.3 For transmitters rated at a maximum output power not listed above, the recommended separation distance d inmetres (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 reection from structures, objects and people.Rated maximum output power of transmitter(W)Separation distance according to frequency of transmitter (m)150 KHz to 80 MHz0.010.11101000.120.381.23.8120.120.381.23.8120.230.732.37.32380 MHz to 800 MHz 800 MHz to 2.5 GHz
Caution: The user is cautioned that changes or modications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:■ this device may not cause harmful interference, and■ this device must accept any interference received, including interference that may cause undesired operation.NOTE: This 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 canradiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does 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.FCC Radiation Exposure Statement:This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be colocated or operating in conjunction with any other antenna or transmitter.42FCC Compliance information
43 WARRANTYPlease contact Carex Health Brands in case of a claim under the warranty. If you have to send in the unit, enclose a copy of your receipt and clearly state the defect. The following warranty terms apply: 1) The warranty period for the device is one year from date of purchase. In case of a warranty claim, the date of purchase has to be proven by means of the sales receipt or invoice.2) Repairs under warranty do not extend the warranty period for the device or for the replacement parts.3) The following is excluded under the warranty: ■ ■ ■ ■ All damage due to improper treatment, e.g. nonobservance of the user instruction. n All damage due to repairs or tampering by the customer or unauthorized third parties.Damage during transport from the manufacturer to the consumer or during transport to the retailer. n Accessories which are subject to normal wear and tear. 4) Liability for direct or indirect consequential losses caused by the unit is excluded even if the damage to the unit is accepted as a warranty claim.
Manufactured for: Carex Health BrandsMiddleburg Heights, OH 44130A division of Compass Health Brands Tel: 800-328-2935 customerservice@carex.com Copyright 2017 by Carex Health Brands

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