Easy Care - Electronic muscle stimulator TERRAILLON - Free user manual and instructions

USER MANUAL Easy Care TERRAILLON

PROBLÈME CAUSES POSSIBLES SOLUTION POSSIBLE

PROBLÈME CAUSES POSSIBLES SOLUTION POSSIBLE

CONTRAINDICATIONS Consult with your physician before using this device, because the device may cause lethal rhythm disturbances in certain susceptible individuals. DO NOT USE THIS DEVICE UNDER THESE CONDITIONS:

If you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.

• Together with a life-supporting medical electronic device such as an artificial heart, lung or respirator.

• In the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when the electrical stimulation device is in use. WARNING

• On open wounds or rashes, over swollen, red, infected, inflamed 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.

• On the opposite sides of your head since the effects of stimulation of the brain are unknown. DO NOT USE ON THESE INDIVIDUALS:

• Pregnant women, because the safety of electrical stimulation during pregnancy has not been established.

IMPORTANT SAFETY PRECAUTIONS AND WARNINGS

Dear Customer, Thank you for purchasing this product. It 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.EN

• Children or infants, because the device has not been evaluated for pediatric use.

• Persons incapable of expressing their thoughts or intentions. DO NOT USE THIS DEVICE DURING THESE ACTIVITIES:

• Driving, operating machinery or any activity in which electrical stimulation can put you at risk for injury. PRECAUTIONS

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 five 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 confirm that it is advisable for you to use this unit.

WARNINGS AND PRECAUTIONS REGARDING THE PADS

• Apply pads to normal, healthy, clean, dry skin (of adult patients).

• If you experience any skin irritation or redness after a session, do not continue stimulation on that area of the skin.

• Never apply the pads to: - The head or any area of the face. - The neck or any area of the throat because this can cause severe muscle spasms resulting in closure of the airway, difficulty breathing, or adverse effects on heart rhythm or blood pressure. - Both sides of the thorax simultaneously (lateral or front and back), or across your chest because the introduction of electrical current may cause rhythm disturbances, which could be lethal.EN

• Do not bend or fold because the pad may not function properly. Place the pads onto the plastic film and then store in the sealed package when not in use.

• Do not apply ointment or any solvent to the pads or to your skin because it will keep 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 film provided.

• Make sure the components are connected well and the pads are fixed on the part of the body you wish to treat or the therapy may not be effective. DO NOT USE YOUR PADS THIS WAY:

• Pads should not touch each other when placed onto your skin.

• Do not place on your spine or backbone.

• Pads should not touch any metal object, such as a belt buckle, necklace or other jewelry made from metal.

• Pads should not be placed simultaneously on the soles of both feet.

• Pads should not be placed simultaneously on the calves of both legs.

• Do not share pads with another person. This may cause a skin irritation or infection. Pads are intended for use by one person.

• Do not place or relocate the pads while the device is on.

• Always turn the power off before removing or changing the pad location.

• Do not leave pads attached to the skin after treatment.

CAUTION WHILE USING THE UNIT

• If the unit is not functioning properly or you feel discomfort, immediately stop using the device.

• Do not use for any other purpose except as described in this manual.

• The electrode press studs are only compatible with the product unit.

• Do not mix alkaline and manganese batteries, as this will shorten the battery life.EN

• Do not use the device while wearing electronic devices such as watches as this may damage the device.

• Do not use near a cell phone as this may cause the unit to malfunction.

• The size, shape and type of pads may affect the safety and effectiveness of electrical stimulation.

• The electrical performance characteristics of theb 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.

• Only use the Terraillon electrodes provided for this purpose.

• Do not use the device or an electrode if it is damaged. The continuous use of a damaged unit may cause injury, improper results, or serious danger.

• Do not throw the batteries into a fire. The batteries may explode.

• Dispose of the device, batteries, and components according to applicable legal regulations. Unlawful disposal may cause environmental pollution. GENERAL PRECAUTIONS

• 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.

• 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.

• Effectiveness is highly dependent upon patient selection by a practitioner qualified in the management of pain patients.EN

• You may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium (gel) on the electrodes.

• 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.

• Use caution if you have a tendency to bleed internally, such as following an injury or fracture.

• 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 the menstruating or pregnant uterus.

• This stimulation should not be applied over areas of skin that lack normal sensation.

• Keep unit away from young children. The unit contains small pieces that may be swallowed. Contact your physician immediately if ingested.

• To achieve the best results, use this device with the electrodes and the unit supplied by the manufacturer.

POSSIBLE ADVERSE REACTIONS

• Do not use this device to treat an area for extended periods (3 x 30 minutes per session or 90 minutes a day).

• You may experience skin irritation and burns beneath the stimulation electrodes applied to your skin.

• 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 consult with your physician if you experience adverse reactions from using the device.EN

• Do not use this device over your eyes, mouth, face, front of neck (especially in the carotid sinus) head, upper back, or across your heart because this could cause severe muscle spasms resulting in closure of your airway, difficulty breathing or adverse effects on heart rhythm or blood pressure.

• Do not use this device over, or in proximity to cancerous lesions.

• Do not operate in close proximity (e.g. 1m) to shortwave or microwave therapy equipment as it may produce instability in the simulator output.

• Do not use the device if you are connected to high-frequency surgical equipment. This may result in burns on the skin under the electrodes and may damage the device.

• This device should not be applied on or across your head or face since the effects of stimulator of the brain are unknown.

• Use this device with caution if you have a tendency to bleed internally, such as following an injury or fracture.

• Consult with your physician prior to using this device after a recent surgical procedure, because stimulation may disrupt the healing process.

• Do not use this device for pain of the central origin, including headache.

• This device is not to be used in the presence of flammable or anesthesia gasses.

• This product is not intended to be used during physical activity as interrupting the current by moving the electrode could result in shock.

• The electrode should not be applied to the skin for long periods of time or when not in use otherwise this could result in skin irritation.EN

What is it? EASY CARE is a device for effectively providing relief for acute post- operative pain or mild to moderate chronic pain. Transcutaneous electrical nerve stimulation (TENS) is a technology currently recommended by doctors, physiotherapists and pharmacists all over 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 the nerves to modify 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 reducing or eliminating the pain, allowing for a return to normal activity. How TENS works? 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 the pain message from the source of pain from ever reaching the brain.

What is it? EMS 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. How EMS works? 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. 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 S F 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 stimulation program that is used with the EMS mode of stimulation to facilitate recovery from muscle fatigue and to help recover muscle strength after training sessions and competitions.EN

2 AAA batteries 1 self-adhesive electrode (2.1 x 6.8 cm) Start/Stop button and program selection Battery compartment Electrode connectors LED indicators Increase the intensity Reduce the intensityEN

• EASY CARE offers 15 programs (5 TENS, 5 EMS and 5 MASSAGE) specifically adapted to different types of pain.

• 3 well-being modes (TENS, EMS and MASSAGE).

• 15 treatment intensity levels, from low-intensity (1) to high-intensity (15).EN

1. Open the battery compartment on the back of

the electrical muscle stimulator using a sharp implement such as a pen or a flat screwdriver.

2. Insert 2xAAA batteries. Make sure the positive

+ and negative – signs correspond with the markings in the device when inserting batteries.

3. Reinstall the battery cover as shown by the

graphic to the right. Notes:

• Please use 2×AAA batteries in this unit.

• Service life of the battery: 20 uses.

• 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.

• Warning: If batteries leak and come into contact with the skin or eyes, wash immediately with large amounts of water.

• Batteries must be handled by an adult. Keep batteries out of the reach of children.

• Remove exhausted batteries from the unit.

• Dispose the used batteries safely according to local regulations.EN

OPERATION STAGE 1 Clean your skin. Using a damp towel, clean then dry your skin. Avoid areas with dense hair growth. STAGE 2 Remove the electrodes from the box. Make sure that the device is switched off. Clip the electrodes to the electro-stimulator. Never remove the electrodes from the skin when the device is switched on. STAGE 3 Fitting the electrode Remove the plastic film on the back of the electrode. Keep the plastic film so that you can put it back onto the electrode at the end of the session.EN

Arrange the electrodes over the treatment area (see the diagrams for positioning the electrodes). Make sure that the electrodes are placed on clean, dry and healthy skin, close to or around the site of pain. STAGE 4 Switch on the device Press the button to turn on the device.EN

STAGE 5 Select the treatment program. EASY CARE provides you with a choice of: 3 treatment modes: TENS/EMS/MASS Press the button several times to cycle through to the desired treatment mode. Press the (+) button to confirm the mode (TENS/EMS/MASS). The light flashes. STAGE 6 Select the program by pressing (-) button several times (1 to 5). Start the program by pressing (+) or (-) until the desired intensity level is reached. The maximum intensity level goes up to 15. When the program has finished, the device is automatically switched off. CAUTION:

• If the electrodes are not placed firmly on skin, or the device has not connected with the electrodes, and the output intensity level is over 1, the intensity will stop automatically.EN

• If the stimulation levels are uncomfortable or become uncomfortable, reduce the stimulation intensity to a comfortable level and contact your medical practitioner if problems persist.

• If your pain does not improve and you become sore from over-use, refrain from treating those areas for two (2) days. If this issue reoccurs, reduce the treatment time and intensity settings for future treatment.

• If you feel pain, dizziness, discomfort or nausea, call your physician or medical practitioner.

• Caution should be used when working with maximum intensities, (i.e., always at the limit of what you can support.) Do not exceed your comfort level. STAGE 7: Turn off the device. Press the button and hold for two (2) seconds to turn off the device. The device switches off automatically after three minutes of inactivity. STAGE 8: Cleaning the unit

2. Remove the electrode from the electro-stimulator.

3. Clean the device after use with a soft, slightly moistened

• Do not use chemicals (like thinner, benzene).

• Do not let water get into the internal area. Note:

• This device and accessories do not require sterilization. Cleaning the electrode pads

1. Turn the power off.

2. Wash the pads when the adhesive surface becomes dirty

and/or the pads are difficult to attach.EN

• Wash the pad softly with your fingertips under slow running cold water for several seconds (do not use a sponge/cloth/sharp object like a nail on the adhesive side. Do not use detergents, chemicals or soap).

3. 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 (can be used 15 times).

• If the pads no longer sticks to your skin or the pads are broken, you should replace them with new pads STAGE 9 Storing the device Put the device and the electrodes back into their original box.

• Store the device in the dry, clean place, the electrodes and cables in the bag provided. Store in a dry place, -10°C~55°C; 10%~90% relative humidity. Failing to do so may affect the performance of the stimulator.

• Do not store in places that can be easily reached by children.

• It is forbidden to leave the product exposed to any chemical solvent, lint, dust, direct sunshine or high temperature.

• When not in use for a long period, remove the batteries before storage to avoid liquid discharge from batteries.EN

• Treatment time: Between 15 and 42 minutes

• Operating Conditions: 5°C~40°C; 30%RH~75%RH ;700hPa-1060hPa

• Storage and Transportation Conditions: -10°C~55°C; 10%RH~90%RH;

• Size: 80 x 46 x 20,5 mm

• Weight: about 45g (include batteries)

• Service life of the device: 2 years

• Service life of the electrodes: 15 uses

• Service life of the battery: 20 uses

• IP classification: IP22

PROTECT THE ENVIRONEMENT

Used batteries should be placed in the appropriate collection bin so they can be recycled. Do not mix different types of batteries, or use new and old batteries at the same time. At the end of its serviceable life, this product must be disposed of at a recycling centre for electrical and electronic equipment. WARRANTY This product is guaranteed against defects in materials or manufacturing. During the guarantee period, any such defects will be replaced free of charge (proof of purchase must be shown in the case of a complaint under guarantee). The guarantee does not cover damage resulting from improper use or negligence. In the event of a claim, first contact the shop where you purchased the product.EN

TROUBLESHOOTING If the unit does not operate after taking these measures, contact the nearest dealer.

PROBLEM POSSIBLE CAUSES POSSIBLE SOLUTION

The unit cannot power on Are the batteries exhausted? Replace the batteries. Are the batteries installed correctly? Insert the batteries observing polarity. Stimulation weak or cannot feel any stimulation Electrodes are dried out or dirty. Replace with new electrodes. Electrodes do not stick to skin well. Replace with new electrodes. Poorly positioned electrodes. Switch off the device and reposition the electrode on your skin then switch back on. Stimulation is uncomfortable Intensity is too high. Decrease intensity. Electrodes are too close together. Reposition electrodes to be at least 2 inches apart. Is the device being operated according to the manual? Please check the manual before use.EN

PROBLEM 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 pain. Using 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 therapy. The electrodes come off the skin. Turn off the device and place the electrodes on again, or replace with new electrodes.EN

Disposal in accordance with Directive 2012/19/EU (WEEE) Caution Type BF Applied Part (The applied part is the electrode) Refer to instruction manual The first number 2: Protected against solid foreign objects of 12,5 mm Ø 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. The name and the address of the authorised representative in the European Community Represent the manufactuer date and Serial number. The name and the address of the manufacturer Complies with the European Medical Device Directive (93/42/EEC) and amended by directive 2007/47/EC requirements. Notified body TÜV Rheinland (CE0197) IP22 SNEN

With the increased number of electronic devices such as PC’s and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation. Medical devices should also not interfere with other devices. In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the IEC 60601-1-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices. The device conforms to this IEC 60601-1-2 standard for both immunity and emissions. Nevertheless, special precautions need to be observed:

• The use of accessories and cables other than those specified by manufacturer with the exception of cables sold by manufacturer as replacement parts for internal components, may result in increased emission or decreased immunity of the device.

• The medical devices should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the medical device should be observed to verify normal operation in the configuration in which it will be used.

• Refer to further guidance below regarding the EMC environment in which the device should be used. IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY (EMC)EN

The device is intended for use in the electromagnetic environment specified below. The customer or the user of device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 The device uses 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. RF emissions CISPR 11 Class B The device is suitable for domestic establishment and in establishment directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions

Not applicable Voltage fluctuations/flicker emissions

The device is intended for use in the electromagnetic environment specified below. The customer or the user of device should assure that it is used in such an environment. Immunity test IEC 60601test level Compliance level Electromagnetic environment - guidance 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 tie. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Electrical fast transient/burst

± 2 kV for power supply lines ± 1 kV for input/output lines Not applicable Mains power quality should be that of a typical commercial or hospital environment. Surge

± 0.5kV, ± 1 kV line(s) to lines ± 0.5kV, ± 1 kV, ± 2 kV line(s) to earth Not applicable Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines

0 % UT; 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270°and 315° 0 % UT; 1 cycle and 70 % UT; 25/30 cycles Single phase: at 0° 0 % UT; 250/300 cycles Not applicable Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery. Power frequency (50/60 Hz) magnetic field

30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level.EN

The device is intended for use in the electromagnetic environment specified below. The customer or the user of device should assure that it is used in such an environment. Immunity test IEC 60601test level Compliance level Electromagnetic environment - guidance Conducted RF

6 V in ISM and amateur radio bands between 0.15 MHz and 80 MHz Not applicable Portable and mobile RF communications equipment should be used no closer to any part of device, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1,2 150 kHz to 80 MHz d = 1,2 80 MHz to 800 MHz d = 2,3 80 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,

should be less than the compliance level in each frequency range

Interference may occur in the vicinity of equipment marked with the following symbol: Radiated RF

10V/m 80 MHz to 2.7 GHz 10 V/mEN

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 RF 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 device is used exceeds the applicable RF compliance level above, device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating device. b Over the frequency range 0.15 MHz to 80 MHz, field strengths should be less than 3 V/m.EN

PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND DEVICE The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and device, 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 0,15 MHz to 80 MHz d = 1,2 80 MHz to 800 MHz d = 1,2 80 MHz to 2,7 GHz d = 2,3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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 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.DE

• Stroombron: 3,0 V DC, 2 x AAA-batterijen