Beurer EM 50 Menstrual Relax User Manual

Beurer EM 50 Menstrual Relax User Manual

Please read these instructions for use carefully and keep them for later use, make them accessible to other users, and observe the information they contain.

GETTING TO KNOW YOUR DEVICE

What is the EM 55 Plus Menstrual Relax?
Many women experience abdominal cramps and severe menstrual pain before and during their period. On top of that, a lot of women also suffer from illnesses which cause pain in the lower abdomen, such as endometriosis. This pain is often so severe that women seek immediate pain relief. The innovative Menstrual Relax is a self-adhesive TENS device with a heat function to provide pain relief for menstrual discomfort and pain caused by endometriosis. The TENS technology used in the Menstrual Relax can treat pain in a targeted manner. The Menstrual Relax has a total of 15 intensity levels.
To alleviate pain even more pleasantly, a soothing heat function can be activated. Made from medical-quality silicone, the elegantly designed Menstrual Relax is extremely slim and flexible, and adapts perfectly to the area to be treated. The battery ensures energy-efficient treatments of 20 minutes each (up to 6 treatments are possible per battery charge).

What is TENS and what can it do?
TENS, or transcutaneous electrical nerve stimulation, refers to the electrical stimulation of nerves through the skin. TENS is an effective non- pharmacological method for treating different types of pain from a variety of causes. It 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-relief or pain-suppressing effect is achieved by inhibiting the transfer of pain within nerve fibres and by increasing the secretion of endorphins within the body, as their effect on the central nervous system reduces the sensation of pain. The method has been 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 doctor will also give you instructions on how to carry out a TENS self- treatment regime. TENS has been clinically tested and approved for menstrual discomfort and for the relief of pain caused by endometriosis.
TENS devices work by passing electrical currents over the skin. The gel pads are used as a transfer medium and are subject to natural wear and tear. The gel pads must be replaced when they stop providing sufficient contact and the Menstrual Relax no longer sticks to the skin completely. Failure to replace the pads may lead to skin irritation as a result of heightened current density in particular areas.

INCLUDED IN DELIVERY

Check that the exterior of the cardboard delivery packaging is intact and make sure
that all contents are present. Before use, ensure that there is no visible damage to the device or accessories and that all packaging material has been removed. If you have any doubts, do not use the device and contact your retailer or the customer service address provided.
1x Menstrual Relax, 4x self-adhesive gel pads, 1x USB-C cable, 1x these instructions for use

SIGNS AND SYMBOLS

| Disposal in accordance with the Waste Electrical and Electronic Equipment EC Directive – WEEE.
---|---

Pb Cd Hg| Do not dispose of batteries containing harmful substances with household waste
| WARNING Warning indicating a risk of injury or damage to your health
| CAUTION Safety note indicating possible damage to the device/accessory
| The device can emit effective output values above 10 mA, averaged over every 5-second interval.
| Note
Note on important information
| Manufacture
| Date of manufacture
| Type BF applied part Galvanically isolated applied part (F stands for “floating”); meets the requirements for leakage currents for type B
| Do not use if you have implanted electrical devices (e.g. a pacemaker)
| Do not use near the heart
| CE labelling This product satisfies the requirements of the applicable European and national directives.
IP22| IP class Device protected against foreign objects ≥12.5 mm and against water dripping at an angle
| Use by
| Observe the instructions
Read the instructions before starting work and/or operating devices or machines
| Permissible storage temperature and humidity
| Permissible operating temperature and humidity
| Permissible transport temperature and humidity
| Separate the packaging elements and dispose of them in accordance with local regulations.
| Marking to identify the packaging material. A = material abbreviation, B = material number: 1–7 = plastics, 20–22 = paper and cardboard
| Separate the product and packaging elements and dispose of them in accordance with local regulations.
SN| Serial number
MD| Medical device
REF| Article number
| Type number
| Importeur Symbo

The following symbols are used on the device, in these instructions for use, on the packaging and on the type plate for the device:INTENDED USE FOR TENSThe device is intended to treat pain using TENS technology (transcutaneous electrical nerve stimulation).
Target group
This device is intended for self-treatment in the home, not in professional healthcare facilities. The application is suitable for all adults.
Clinical benefits:
Pain relief for menstrual discomfort and pain due to endometriosis.
Indications

• Period pain in women
• Pain due to endometriosis

Contraindications:

• Stimulation should not be carried out

  • on or through the head,
  • directly on the eyes,
  • over the mouth,
  • on the front of the neck (particularly not the carotid sinus), or
  • with the electrode surfaces placed on the chest, upper back or
  • across the heart.

• 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 located), and especially not on the two large pectorals. This can increase the risk of ventricular fibrillation and induce cardiac arrest (see Chapter 5 General Warnings).

• Do NOT use the device

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

  • In the neck/carotid artery area.
    

  • In the genital area.

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

  • If you have metal implants (e.g. IUDs).

  • If you use an insulin pump.

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

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

  • On acutely or chronically diseased (injured or irritated) skin (e.g. inflamed skin – whether painful or not, reddened skin, rashes (e.g. allergies), burns, bruises, swellings, both open and healing wounds, and post-operative scars that are healing).

  • 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 healing process.

  • If you are connected to a high-frequency surgical device.

  • If you have an acute or chronic disease of the gastrointestinal tract.

Warning! Undesirable side effects

• Skin irritation

GENERAL WARNINGSGeneral warnings

The device is not a substitute for medical consultation and treatment. Always consult your doctor first in the event of pain or illness. Before using the device, consult your doctor if any of the following apply to you:

• If you suffer from an acute medical condition, 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.
• If you have any skin diseases or open wounds.
• If you have unexplained chronic pain in any part of the body.
• If you suffer from diabetes.
• If you have any sensory impairment that reduces the feeling of pain (e.g. metabolic disorders).
• If you are receiving medical treatment.
• In the event of complaints linked to the stimulation treatment.
• If you suffer from persistently irritated skin due to long-term stimulation at the same electrode site.

Only use the Menstrual Relax:

• On people.
• For the intended purpose and as specified in these instructions for use. Any form of improper use can be dangerous.
• For external use only.
• With the original accessories supplied, which can be re-ordered. Failure to do so invalidates the warranty.
• This device is NOT intended for use by people with restricted physical, sensory or mental skills or a lack of experience and/or a lack of knowledge, unless they are supervised by a person who has responsibility for their safety or they receive instructions from this person on how to use the device.
• Children must not play with the device.
• The device is only intended for domestic/private use, not for commercial use.

General precautions

• Do not use in humid environments (e.g. in the bathroom) or when bathing or showering.
• Do not use after consuming alcohol.
• Always pull gently on electrodes to remove them from the skin to prevent injuries in the unusual case of highly sensitive skin.
• Hold the device away from sources of heat and do not use it in close proximity (approx. 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 impact, dust, dirt and moisture.
• Never immerse the device in water or other liquids.
• The device is suitable for self-treatment.
• For hygiene reasons, the electrodes may only be used on one person.
• If the device does not work properly, or if you feel unwell or experience pain, stop using it immediately.
• Switch off the device first before removing or relocating electrodes to prevent unintentional stimulation.
• Do not modify the Menstrual Relax (e.g. by trimming). This increases the current density, which is potentially hazardous (max. recommended output value for the electrodes is 9 mA/cm², an effective current density beyond 2 mA/cm² requires increased awareness).
• Make sure that the electrodes are in full contact with the skin.
• If the electrodes wear out, skin irritation can occur as an even distribution of current over the entire surface is no longer guaranteed. For this reason, the electrodes should be replaced.
• Do not use whilst asleep, driving a vehicle or operating machinery.
• Do not use whilst undertaking any activity where an unexpected reaction (e.g. strong muscle contractions even at low intensity) could be dangerous.
• Ensure that no metallic objects (e.g. belt buckles or necklaces) come into contact with the electrodes during stimulation. If you are wearing 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 this could result in spot burns.
• Keep the device away from children to prevent potential hazards.
• Do not use this device whilst using other devices that transmit electrical impulses to your body.
• Do not use in the vicinity of highly flammable substances, gases or explosives.
• 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 minutes).
• Treatment of the skin with moisturising lotions or ointments beforehand is not recommended as this considerably increases the electrode wear and may cause unpleasant current peaks.
• Keep packaging material away from children (risk of suffocation!).
• Store the device in a dry place (use indoors only). To avoid the risk of fire and/or electric shock, protect the device from high humidity and water.
• The actual temperature of the Menstrual Relax may vary depending on the condition of your skin, your age, the location of the pain, etc.
• If the heat function feels too hot, stop treatment immediately. You can continue the TENS treatment without the heat function.
• Wait at least one hour after eating before starting treatment with the Menstrual Relax.

The gel pads can be used for a maximum of 20 applications (this can varygreatly depending on the skin type and structure).

• * Use the gel pads on clean, dry skin and avoid lotions or greasy creams.

  • Do not use on open wounds.
  • Consult your doctor if you have sensitive skin.

Damage

• If your skin or eyes come into contact with fluid from a battery cell, wash the affected area with water and seek medical assistance.
• If the device is damaged, do not use it and contact your retailer or the specified

Customer Services address.

• To ensure that the device functions effectively, do not drop it or dismantle it.
• Check the device for signs of wear and tear or damage. If there are such signs of wear and tear or damage or if the device was used improperly, it must be returned to the manufacturer or retailer before further use.
• Switch the device off immediately if it is faulty or not working properly.
• Never attempt to open and/or repair the device yourself. Repairs may only be carried out by Customer Services or authorised retailers. Failure to comply with this instruction will void the warranty.
• The manufacturer is not liable for damage resulting from improper or incorrect use.

WARNING

Notes on handling batteries

• If your skin or eyes come into contact with fluid from a battery cell, wash the affected area with water and seek medical assistance.
• Choking hazard! Small children could swallow and choke on batteries. Therefore, keep batteries out of the reach of small children!
• If a battery has leaked, put on protective gloves to handle the device.
• Protect batteries from excessive heat.
• Risk of explosion! Never throw batteries into a fire.
• Do not disassemble, split or crush the batteries.
• Only use chargers specified in the instructions for use.
• Batteries must be charged correctly prior to use. The instructions from the manufacturer and the specifications in these instructions for use regarding correct charging must be observed at all times.
• Fully charge the battery prior to initial use (see section 6).
• In order to achieve as long a battery service life as possible, fully charge the battery at least every 6 months.

CAUTION

• Protect the device from heavy impacts.
• Do not use the device if it shows signs of damage or does not function properly.In these cases, contact Customer Services.
• Do not expose the device to direct sunlight or high temperatures.
• Protect the device from dust, dirt and moisture. Never immerse the device in water or other liquids.
• Do not use this device by or in the vicinity of other heating devices, heating elements such as dryers or ovens, and do not use it in the vicinity (~1 m) of shortwave or microwave devices (e.g. mobile phones), as doing so can result in unpleasant current peaks.
• If the device 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.
• Never attempt to open and/or repair the device yourself.
• Repairs may only be carried out by Customer Services or authorised retailers.
  Failure to comply will invalidate the warranty.

DEVICE DESCRIPTION

1. Increase intensity
2. LED heat/battery level indicator
3. TENS LED
4. ON/OFF button
5. Decrease intensity
6. Left electrode
7. Heating surface
8. Right electrode
9. USB-C connection

INITIAL USE

Charging the battery

Note
Before using the Menstrual Relax for the first time, let it charge for a minimum of 2 hours. To do so, proceed as follows:

1. Open the cover of the USB-C connection on the Menstrual Relax.
2. Connect the USB-C charging cable provided to a USB mains adapter (output: max. 5 V/ 2 A, not included in delivery) and the Menstrual Relax.
3. Then insert the mains adapter into a suitable socket.
4. Whilst charging, the battery level indicator LED flashes green. As soon as the Menstrual Relax has been completely charged, the LED battery level indicator will be continuously illuminated in green

Note
You cannot use the Menstrual Relax while it is being charged. Make sure that there is no skin contact with the electrodes during the charging process.
Attaching the gel pads

1. Remove one of the protective films carefully.

2. Carefully attach the gel pad to the Menstrual Relax and then carefully detach the second protective film. Ensure that the edge of the gel pads does not protrude over the Menstrual Relax. Attach one gel pad to each electrode.

WARNING
Remove the protective film slowly and carefully. Make sure that the self- adhesive gel pads are not damaged, as damage or unevenness on the film may cause skin irritation.

USAGE

Starting use
Note
In total, the Menstrual Relax has one heat setting with heat generation up to 43 °C maximum, and 15 intensity levels for TENS application. We recommend you start off using a low intensity level until you have got used to the device. The Menstrual Relax has an automatic switch-off function. After 20 minutes of use, it automatically switches itself off.

1. Stick the Menstrual Relax onto your lower abdomen. You can attach the pad flexibly depending on where the pain is. Just make sure that the electrodes do not come into contact with the hip bones.

2. Briefly hold down the ON/OFF button to switch on the pad. The heat LED flashes green and the Menstrual Relax begins to heat up. If the heat LEDflashes orange, please charge the Menstrual Relax as described in the “Charging the battery” section.

3. To switch on electrical nerve stimulation (TENS), briefly press the ON/OFF button again. The TENS LED flashes. To start stimulation, press the button once. The lowest intensity is now activated.

4. If you want to use the TENS function without heat function, press the ON/OFF button again. Now only the TENS LED is flashing and you can start stimulation by pressing the button.

5. Select your desired intensity level using the buttons.

6. To switch off the Menstrual Relax, press and hold the ON/OFF button for 3 seconds. The heat LED and the TENS LED go out.

7. Switch off the Menstrual Relax before removing it. After using the Menstrual Relax, take care when removing it from your lower abdomen. Reapply the protective films to the gel pads to protect them.

WARNING!
Make sure that you can access the control unit quickly during the treatment so that you can stop the treatment promptly if it is unpleasant.

Notes on use

• Wait at least 30 minutes between applications.

• Only use the Menstrual Relax as often as you find comfortable. If treatment withthe Menstrual Relax starts to feel unpleasant, stop using it.

• The Menstrual Relax has a function which detects whether the device is in contact with the body. If there is not sufficient contact with the body, the device beeps and switches itself off. If the device is attached to your body but still beeps, clean the gel pads and try starting the device again. If the continuous beeping persists, replace the gel pads.

• If the adhesive capability of the gel pads decreases, replace them immediately.
  Do not use the Menstrual Relax again until the gel pads have been replaced. Otherwise the uneven adhesion of the gel pads could lead to skin lesions.

• In the event of unpleasant current peaks, switch off the Menstrual Relax and move it slightly.

• If you find that using the Menstrual Relax causes you to have a much heavier flow, stop using it.

WARNING!
Do not apply the electrodes to the front wall of the chest.

Programs

Impulse frequency
The frequency indicates the number of individual impulses per second and is displayed in Hz (Hertz). It can be calculated by determining the cyclic value for the time period.

Impulse width
This indicates the duration of an individual impulse in microseconds. The impulse width therefore determines, among other things, the penetration depth of  the electricity, where usually larger muscle mass requires a larger impulse width.

CLEANING AND MAINTENANCE

WARNING

• 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 once it has fully dried out.
• To ensure that the adhesive electrodes retain their adhesion for as long as possible, clean them carefully with a damp, lint-free cloth.
• Do not use any chemical or abrasive cleaning agents for cleaning.

10. ACCESSORIES AND REPLACEMENT PARTS

For accessories and replacement parts, please visit www.beurer.com or contact the corresponding service address in your country (according to the service address list). Accessories and replacement parts are also available from retailers.

WHAT IF THERE ARE PROBLEMS?

The battery may be flat.

| Fully charge the battery. If it is still not possible to switch the device on, please contact Customer Services.
The device does not stick to the body.|

The gel pads may be dirty or worn. The treatment area of theskin may not be clean enough.

| Clean the adhesive surface of the gel pads using a damp, lint-free cloth. The gel pads must be replaced if they still do not stick securely.
Clean the skin prior to any application; do not use skincare lotions or oils prior to treatment. Shaving mayincrease the life of gel pads.
There is no noticeable stimulation.| The gel pads may be dirty or worn. The battery may need charging.| Ensure that the gel pads are in firm contact with the treatment area.
The battery is almost flat. Charge it fully.
An unpleasant sen- sation is experienced where the gel pads are applied.| The gel pads are worn. This may cause skin irritation, as even distribution of the current across the entire area is no longer guaranteed.|

Replace the gel pads.

Skin in the treatment area turns red.

| Redness under the gel pads that disappears quickly is not dangerous, and is caused by the locally stimulated, increased blood flow caused by TENS and heat.| Immediately stop treatment and wait until your skin has re- turned to its normal condition. However, consult your doctor before you continue treatment if the skin irritation persists and if it is accompanied byan itchy sensation or inflam- mation. This may be caused by an allergic reaction to theadhesive surface.

The skin under the heat surface turns red.

| Reddening under the heat surface of the Menstrual Relax can be explained by the heavily stimulated blood flow in the heated tissue.| The skin should return to its normal condition a few min- utes after treatment. However, consult your doctor before continuing to use the heat function if the redness persists and if you experience anyitching or inflammation.
The Menstrual Relax becomes too hot.| | Press the ON/OFF button to stop the heat function and just continue using the TENS function.

DISPOSAL

The empty, completely flat batteries must be disposed of in specially designated collection boxes, at recycling points or at electronics retailers. You are legally required to dispose of the batteries.
The codes below are printed on batteries containing harmful substances:

Pb Cd Hg
Pb = battery contains lead
Cd = battery contains cadmium
Hg = battery contains mercury
For environmental reasons, do not dispose of the device in household waste at the end of its service life. Dispose of the device at a suitable local collection or recycling point in your country. Dispose of the device in accordance with EC Directive Waste Electrical and Electronic Equipment (WEEE). If you have any questions, please contact the local authorities  responsible for waste disposal.

TECHNICAL SPECIFICATIONS

of 15 – 90 %
Storage conditions| 0 °C – 40 °C (32 °F – 104 °F)at a relative air humidity of 0 – 90 %
Dimensions| Approx. 235 x 115 x 20 mm
Weight| 86.1 g

Subject to technical changes.
The serial number is located on the device. This device complies with the European standard EN60601-1-2 (Group 1, Class B, in compliance with CISPR 11, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-8) and is subject to special precautionary measures with regard to the electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this device. More details can be requested from the stated Customer Service address or found at the end of the instructions for use.
For this device, a functional test and instruction in accordance with Section 5 of the Medical Devices Operator Ordinance (MPBetreibV) is not required.
It is also not necessary to carry out safety checks in accordance with Section 6 of the Medical Devices Operator Ordinance (MPBetreibV).

NOTES ON ELECTROMAGNETIC COMPATIBILITY

WARNING

• The device is suitable for use in all environments listed in these instructions for use, including domestic environments.
• The device may not be fully usable in the presence of electromagnetic disturbances. This could result in issues such as error messages or the failure of the display/device.
• Avoid using this device directly next to other devices or stacked on top of other devices, as this could lead to faulty operation. If, however, it is necessary to use the device in the manner stated, this device as well as the other devices must be monitored to ensure they are working properly.
• The use of accessories other than those specified or provided by the manufacturer of this device can lead to an increase in electromagnetic emissions or a decrease in the device’s electromagnetic immunity; this can result in faulty operation.
• Keep portable RF communication devices (including peripheral equipment, such as antenna cables or external antennas) at least 30 cm away from all device parts, including all cables included in delivery. Failure to comply with the above can impair the performance of the device.
• Failure to comply with the above can impair the performance of the device.

WARRANTY/SERVICE

Further information on the warranty and warranty conditions can be found in the warranty leaflet supplied.
Subject to errors and changes

Beurer GmbH, Söflinger Str. 218, 89077 Ulm, Germany
www.beurer.com, www.beurer- gesundheitsratgeber.com, www .beurer-healthguide.com
Beurer UK Ltd., Suite 16, Stonecross Place, Yew Tree Way, WA3 2SH Golborne, United Kingdom

References

• Beurer Gesundheitsratgeber
• Beurer Health Guide
• Beurer — Beurer North America

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