beurer EM 10 Mini Pad Pain Relief For Back Pain User Guide

EM 10 MiniTENS BACK

EM 10 Mini Pad Pain Relief For Back Pain

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Please read these nstructons caretlly before sing the device.

| LOT number
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| Expiry date
| Manutacurer
| 1 x CR2032 bttery
| Important Read instructinos for use
****| This deice complis vith E0 Dirctve S3/42/EEC
| Type BF appledpart

Getting to know your device

1.1 Whatis the MinTENS?
Migraines, cranps acut an g resutng oy and Sonicpain ar al bl varningsigns and eed inmedia et The imoiatve MTTENS i asef-adhesive TENS (ransoaneusseica nenesi- ‘ulation) dewice for pain refi. The MITENS uses TENS/EMS technology for targeted pain relief. Made from medical-uality silicone rubber, the ‘elegantly designed MInTTENS is exremely sim and flexible and adapts perfectly to the area to be reated. The high-tech circuit provides energy- ‘efficient reatments of 20 minutes each (up to 20 treatments per battery).
MINTENS i e and casy wayof elleing panan afers sers a comsiely new eperienceindealng wih pan
1.2 What is TENS and what can it do?
‘TENS, or transcutaneous electrical nerve stimulation, refates to the cectcalsimialon o e nerves athe Scn TENS s an s non- glan“am\uq\m\ ‘method of treating different types of pain that have a variety of causes and has no side-effects if administered correctly. The method has been clinically tested and approved and can be used for simple self-treatment. The pain-relieving or pain-suppressing effect is achieved by inhibiting the transference of pain to nerve fibres (caused mainly by high-frequency impulses) and by increasing the secretion of endorphins in the body. Their effect on the central nervous system re- duces the sensation of pain. The methad is scientifically substantiated and approved as a form of medical treatment.
Any symptoms that could be relieved using TENS must be checked by your GP. Your GP will also give you instructions on how to carry out a TENS self- treatment regime.
1.3 What is the device used for?
This model is used to relieve both general back pain resulting from daily work or household chores and chronic back pain. This is achieved us- ing a combination of the “burst” and “constant stimulation” settings.
TENS devices work by passing electrical currents over the skin. The gel film is used as a transfer medium and is subject to natural wear and tear. The gel film must be replaced if it stops providing sufficient contact, as this will prevent the MiniTENS from sticking to the skin. If it is not teplaced, the partially increased current density could irritate the skin.
Application area

• Back pain, especially in the lumbar and neck regions
• Pain in the lower back
• Pain in the upper back

1.4 Included in the delivery

• 1x MiniTENS

• 1x self-adhesive gel film

• 1x 3VCR2032 battery
  Replacement items

• 1 x self-adhesive gel film and 1 x battery, item no.: 647.15
  When necessary, please contact customer services at the address pro- vided in good time.

IMPORTANT!
The MiniTENS may only be used as follows:

• On people.
• For the intended purpose and as specified in these instructions for use. Improper use can be dangerous.
• For external use only.
• Use only with the original accessories supplied, which can be re-or- dered. Failure to do so invalidates the warranty.

Important information

The device is not a substitute for medical consultation and treat- ment. Consult your doctor first if you are experiencing any pain or are suffering from an illness.
WARNING!
To avoid damage to health, we strongly advise against using the MiniTENS in the following situations:

• If you have implanted electrical devices (e.g. a pacemaker).

• If you have metal implants.

• If you use an insulin pump.

• If you have a high fever (e.g. > 39°C).

• If you have a known or acute cardiac arrhythmia, or disorders of the heart’s impulse and conduction system.

• If you suffer from a seizure disorder (e.g. epilepsy).

• If you are pregnant.

• If you have cancer.

• After an operation, if strong muscle contractions could affect the heal- ing process.

• The device must never be used near to the heart. The Stimulation electrodes must not be placed on any part of the front ribcage (where the ribs and breastbone are lo- cated), especially not on the two large pectorals. This can increase the risk of ventricular fibrillation and induce cardiac arrest.

• On the skeletal skull structure, or around the mouth, throat or larynx.

• In the neck area / carotid artery area / above the neck.

• Inthe genital area.

• On acutely or chronically diseased (injured or irritated} skin (e.g. in- flamed skin — whether painful or not, reddened skin, rashes, e.g. al- lergies, bums, bruises, swellings, both open and healing wounds, and post-operative scars where the healing process could be affected).

• In humid environments (e.g. in the bathroom) or when bathing or showering.

• Do not use after consuming alcohol.

• Do not use if connected to a high-frequency surgical device.

• for acute or chronic diseases of the gastrointestinal tract.
  Before using the device, consult your doctor if any of the fol- lowing applies to you:

• Serious illnesses, in particular if you suspect or have been diagnosed with high blood pressure, a blood coagulation disorder, propensity to thrombo-embolic conditions or recurrent malignant growths.

• Skin diseases or open wounds.

• Unexplained chronic pain in any part of the body.

• Diabetes.

• Any sensory impairment that reduces the feeling of pain (e.g. meta- bolic disorders).

• If you are receiving medical treatment.

• If you are already having stimulation treatment for existing conditions.

• If you suffer from persistently irritated skin due to long-term stimula- tion at the same electrode site.
  Notes on handling batteries

• If your skin or eyes come into contact with battery fluid, flush out the affected areas with water and seek medical assistance.

• **** Choking hazard! Small children may swallow and choke on bat- teries. Store the batteries out of the reach of small children.

• Observe the plus (+) and minus (-) polarity signs.

• If abattery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.

• Protect the batteries from excessive heat.

• **** Risk ot explosion! Never throw batteries into a fire.

• Do not charge or short-circuit batteries.

• If the device is not to be used for a long period, take the batteries out of the battery compartment.

• Use identical or equivalent battery types only.

• Always replace all batteries at the same time.

• Do not use rechargeable batteries.

• Do not disassemble, split or crush the batteries.

• Remove the battery from the item if it is empty or you do not intend to use the item for a prolonged period of time. This prevents damage which could cecur due to leakage.

• If required, clean the battery and device contacts before inserting.”
  Risk of overheating!
  PRECAUTIONS:

• Hold the device away from sources of heat and do not use it in close proximity (c. 1 m) to shortwave or microwave devices (e.g. mobile phones), as doing so can result in unpleasant current peaks.

• Do not expose the device to direct sunlight or high temperatures.

• Protect the device from dust, dirt and humidity. Never immerse the device in water or other liquids.

• The device is suitable for self-treatment

• If the device does not work properly, or you feel unwell or experience pain, stop using it immediately.

• Switch off the MiniTENS before you attach or remove it.

• Do not adapt the MiniTENS in any way, for example, by cutting or trim-ming it. This will produce a higher current density and can be dangerous.

• Do not use whilst asleep, driving a vehicle or operating machinery.

• Do not use whilst undertaking any activity where an unexpected re- action (e.g. strong muscle contractions even at low intensity) could be dangerous.

• Wait at least one hour after eating before using the mini pad in the stomach area.

• Do not use on wet skin if this reduces the adhesive capability of the mini pad.

• Ensure that no metallic objects (e.g. belt buckles or necklaces) come into contact with the electrodes during stimulation. If you are wear- ing jewellery or have piercings in the area to be treated (e.g. a navel piercing), these must be removed before using the device. Failure to do so could result in spot bums.

• Keep the device away from children.

• This device may be used by children over the age of 8 and by people with reduced physical, sensory or mental skills or a lack of expeni- ence or knowledge, provided that they are supervised or have been instructed on how to use the device safely, and are fully aware of the consequent risks of use. Children must not play with the device.
  Cleaning and user maintenance must not be performed by children unless supervised.

• Pre-treating the skin with greasy creams or lotions is not recom- mended.

• Do not use adhesive tapes, bandages or any aid other than the desig- nated gel film to apply the mini pad to your skin. Otherwise the unequal distribution of the gel film could lead to skin lesions.

• During the initial few minutes, use the device while sitting or lying down to minimise the risk of accidental injuries as a consequence of isolated cases of vagal responses (feeling of faintness). If you feel faint, switch off the device immediately, lie down and support the legs in an elevated position (approx. 5 -— 10 min).
  Damage

• If the MiniTENS is damaged or you have any doubts, do not use it and contact your retailer or customer services at the address provided.

• Switch the device off immediately if it is faulty or not working properly.

• Do not attempt to open and/or repair the MiniTENS yourself. Repairs may only be carried out by customer services or authorised suppliers.
  Failure to comply will invalidate the warranty.

• The manufacturer is not liable for damage resulting from improper or careless use.
  Cleaning

• Remove the batteries from the device before cleaning.

• Clean the device after use with a soft, slightly damp cloth. If it is very dirty, you can also moisten the cloth with a mild soapy solution.

• Ensure that no water enters the device. If this happens, only use the device again when it has fully dried out.

• Do not use any chemical or abrasive cleaning agents.

Initial use

3.1 Insert the battery

1. Turn the battery compart- ment lid anti-clockwise us- ing a coin.
2. Use a pointed object to loosen the lid.
3. Place the battery in the battery compartment so that the positive terminal (+) faces upwards.
4. Close the lid by tuming it clockwise.

3.2 Attaching the gel film

1. Carefully remove the blue protective film.
2. Carefully attach the gel film to the MiniTENS and detach the pro- fective film. Ensure that the edge of the gel film does not protrude over the MiniTENS.

WARNING!
Make sure that you attach the gel film on the side with the blue pro- tective film to the device, otherwise the skin could become irritated.
3.3 Usage
Stick the MiniTENS on the part of the body to be treated.

1. Press and hold the “+” button until you hear a long beep.
2. Press the “+” button again to start the Level 1 stimulation. Keep press- ing the “+” button until you reach the desired intensity.
3. Press the “-” button to reduce the intensity.

Press and hold the “-” button to switch off the MiniTENS.
Important!
Switch off the MiniTENS before you remove it Replace the battery if it is low.

• For optimum stimulation we recommend that the gel film is replaced when batteries are replaced.
• Do not use the MiniTENS on the same area more than once per day.
• In the event of continuous beeping, shut down the device. Clean the gel film and try to restart the program. If the continuous beeping per- sists, replace the gel film.
• if the adhesive capability of the gel film decreases, replace imme- diately. Do not use the device again until the gel film has been re- Placed. Otherwise the unequal distribution of the gel film could lead fo skin lesions.
• In the event of unpleasant current peaks, switch off the MiniTENS and use in a different location.

Programme

Disposal

The empty, completely flat batteries must be disposed of through spe- Cially designated collection boxes, recycling points or electronics re- tailers. You are legally required to dispose of the batteries.
The codes below are printed on batteries containing harmful substances: Pb = Battery contains lead,
Cd = Battery contains cadmium, Hg = Battery contains mercury.
For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Dispose of the unit at a suitable local collection or recycling point. Dispose of the device in accordance with EC Directive – **** WEEE (Waste Electrical and Electronic Equipment). If you have any ques- tions, please contact the local authorities responsitte for waste disposal.

Technical specifications

of 30-85%
Storage conditions| -10 °C — 50 °C (14 °F — 122 °F) with a relative humidity of 10-95%
Dimensions| 112 x7.2 x10 mm
Weight| 14 g (without battery),
17 g (with battery)

Note:
If the device is used other than in accordance with the specifications, perfect functioning cannot be guaranteed!
We reserve the right to make technical changes to improve and de- velop the product.
This device complies with European standards EN60601-1, EN60601- 1-2 and EN60601-2-10 and is subject to special precautionary meas- ures with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this device. For more details, please contact customer services at the address provided.
This device meets the requirements of European Directive 93/42/EC for medical devices, as well as those of the Medical Devices Act.

Subject o emors and changes BeurerGbH,
Sofinger Stz 218,
89077 Uim, Germany
www.beurer.com
www.beurer-heathguide.com

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