BEURER EM 34 - Pain therapy device

EM 34 - Pain therapy device BEURER - Free user manual and instructions

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Brand Beurer
Model EM 34
Product type TENS device for knees and elbows
Dimensions (control unit) 85 × 72 × 31 mm (3.3 × 2.8 × 1.2 in)
Weight (control unit with batteries) 84 g (2.96 oz)
Weight (universal cuff) 113 g (4 oz)
Power supply 3 AAA 1.5 V LR03 batteries (included)
Intensity levels 25 (divided into low, medium, high)
Pulse frequency 2–60 Hz or 2/100 Hz (biphasic)
Pulse duration 300 μs
Max. output voltage 90 Vpp (under 500 ohms)
Max. output current 180 mApp (under 500 ohms)
Treatment modes Automatic and manual (selectable)
Treatment duration 30 minutes per session (auto-off)
Recommended use Maximum 3 sessions of 30 min per day per area
Care and cleaning Clean the cuff with warm soapy water, air dry
Operating conditions Temperature 5–40 °C, humidity 30–75 %
Storage conditions Temperature -10–55 °C, humidity 10–90 %
Included items 1 universal cuff, 1 control unit, 1 connection cable, 3 AAA batteries
Available spare parts Universal cuff, connection cable, batteries
Warranty Limited lifetime warranty for original purchaser
Indications Temporary relief of muscle pain in knees and elbows
Main contraindications Pacemaker wearers, metal implants, pregnancy, epilepsy, cancer, damaged skin

Frequently Asked Questions - EM 34 BEURER

When should I use the EM 34 device?
Use the device as soon as you feel knee or elbow pain. Starting immediately can relieve or avoid chronic pain. The earlier you use it, the higher the chances of relief.
How often can I use the device?
Do not use the device more than three times a day on the same area, each session lasting a maximum of 30 minutes. Start at low intensity. If the pain decreases, stop. If pain is due to overuse, take a two-day break.
When should I stop using the device?
Stop if you feel sharp pain during stimulation, or if side effects occur (skin irritation, redness, burns, headache, weakness). Also stop if the pain does not improve after several treatments, becomes chronic, or lasts more than five days.
What type of pain is the device effective on?
The device is most effective on acute pain (localized, less than three months). It does not treat the source of pain but provides temporary relief. For chronic pain (more than six months), consult a doctor.
Can I use the device if I have a pacemaker?
No, use is contraindicated if you have electronic implants like a pacemaker, metal implants, or an insulin pump. Always consult your doctor if in doubt.
Can I use the device while sleeping or driving?
No, never use the device while sleeping, driving, or operating machinery. An unexpected reaction (muscle contraction) could be dangerous.
How do I clean the cuff?
Disconnect the cable. Clean the cuff in warm soapy water, rinse thoroughly, dab with a towel and let it air dry completely before next use.
What if the device beeps twice when adjusting intensity?
This may indicate that the electrodes are not moist enough or the cable is not properly attached. Re-moisten the electrode covers or check the connections.
How do I replace the batteries?
Remove the battery compartment cover on the bottom of the control unit. Insert three alkaline AAA 1.5 V LR03 batteries, observing polarity. Close the cover.
What should I do in case of skin irritation or redness?
Stop using immediately. Check that the cuff is clean and properly positioned. If redness persists, consult a doctor. Do not use the device on damaged or irritated skin.

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Download the instructions for your Pain therapy device in PDF format for free! Find your manual EM 34 - BEURER and take your electronic device back in hand. On this page are published all the documents necessary for the use of your device. EM 34 by BEURER.

USER MANUAL EM 34 BEURER

Beurer North America LP

900 N Federal Highway, Suite 300

Hallandale Beach, FL 33009

www.beurer.com

EM34

Questions or comments?

Call toll free 1-800-536-0366 or contact info@beurer.com

The following signs appear in the Safety Section (pages 2, 3, 5) and in this manual on pages 6, 10.

READ THIS ENTIRE MANUAL, THE SAFETY SECTION AND ALL INSTRUCTIONS AND WARNINGS COMPLETELY AND CAREFULLY BEFORE USING THIS PRODUCT. FOLLOW ALL SAFETY INSTRUCTIONS AND WARNINGS TO AVOID HAZARDOUS SITUATIONS AND TO MAKE CORRECT USE OF THIS PRODUCT.

  1. Care and Maintenance 10
  2. Troubleshooting Guide 10
  3. Frequently Asked Questions 12
  4. Specifications 13
    12.Warranty 14

BEURER EM 34 - EM34 - 1

This is the safety alert symbol. It

alerts you to potential personal injury hazards. Obey all safety messages that follow this symbol to avoid possible injury or death.

BEURER EM 34 - EM34 - 2

WARNING

WARNING indicates a hazardous situation which, if not avoided, could result in death or serious injury.

BEURER EM 34 - EM34 - 3

CAUTION

CAUTION indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.

NOTICE

NOTICE addresses practices not related to personal injury, such as product and/or property damage.

BEURER EM 34 - EM34 - 4

WARNING

To reduce the risk of fire, electric shock, or serious personal injury:

  • This device is for external use on human knees and elbows only. Do not use this device 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.
  • In combination with electronic life-sustaining devices, such as an artificial heart or lung.
    If you have a fever above 102^ F (39^)
    If you have cardiac arrhythmia or disorders of the heart's impulse and conduction system.
  • After an operation, if muscle contractions could affect the healing process.
    After consuming alcohol.
    If you suffer from a seizure disorder (e.g. epilepsy).
    If you are pregnant.
    If you have cancer.
    If you suffer from metabolic arthritis.

  • 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 postoperative scars where the healing process could be affected).

  • On areas of skin that lack sensitivity.
  • In humid environments (e.g. in the bathroom) or when bathing or showering.
  • In the presence of electronic monitoring systems, such as heart monitors.
  • While asleep, driving a vehicle, or operating machinery.
  • While using other devices that transmit electrical impulses into your body.

  • Keep the device and accessories away from children. The device contains small parts that can be swallowed.

  • Store the device and accessories out of the reach of children. There is a risk of strangulation from the connection cable.
  • This unit is not intended for use by children or persons with physical, sensory (e.g. insensitivity to pain) or mental impairments or those who do not know how to use it due to a lack of experience or knowledge, unless they are supervised by a person responsible for their safe

ty or have received instructions from them on how to use the unit.

  • The device must not be used in combination with electronic life-sustaining devices such as ventilators or other electronic medical products, such as electrocardiographs.
  • If your pain gets worse, becomes chronic, or persists for up to five days, contact your doctor.
  • Do not share this device with anyone else. This could lead to skin irritation or infection. The device is intended for private use only.
  • Do not move or use the cuff if the control unit is switched on.
  • Only connect the connection cable for the electrode plug to the intended control unit and the universal cuff that is included.
  • Do not pull on the connection cables during treatment.
  • Do not bend or pull on the ends of the connection cable.
  • Do not wear any electronic devices, such as watches, while using the device.
  • During treatment, do not touch the water contact electrodes on the universal cuff with your finger.
  • Do not use the device on a particular area more than three times a day with a 30-minute treatment period each time.

If the device does not work properly, or you feel unwell or experience pain, stop using it immediately.
- Do not modify the electrodes as this is potentially hazardous (max. recommended output value for the electrodes is 58.1mA / sq in (9mA / cm^2) , an effective current intensity 12.9mA / sq in (2mA / cm^2) requires increased awareness).
- Do not use while undertaking any activity where an unexpected reaction (e.g. strong muscle contractions even at low intensity) could be dangerous.
- Do not use during strenuous activity (e.g. sports).
- Pre-treating the skin with greasy creams or lotions is not recommended.
- At first, use the device while sitting or lying down to minimize the risk of accidental injuries as a result of feeling faint. If you feel faint, switch off the device immediately, lie down and support the legs in an elevated position (approx. 5 - 10 min).
- Hold the device away from sources of heat and do not use it within three feet (approx. 1 m) of shortwave or microwave devices (e.g. mobile phones).
The device is intended for self-treatment only.
- If there are signs of wear and tear or damage or if the device is used improperly, return it to the manufacturer or retailer.

  • Do not connect the electrodes to other devices.
  • Do not use in near flammable substances, gases, or explosives.
  • Do not attempt to open or repair this device; contact customer service for all repairs.
  • The cuff and the electronic characteristics of this device could influence the safety and effectiveness of the electrical stimulation. Do not use any other TENS devices or cuffs with this product.
  • Before using the device, consult your doctor if any of the following apply:

  • Serious illness, high blood pressure, a blood coagulation disorder, propensity to thromboembolic 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. metabolic 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 stimulation at the same electrode site.

NOTICE:

  • 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.

Battery Handling Safety Precautions

  • only the size and type of batteries specified.
  • Esure to follow the correct polarity when installing the batteries. Reversed batteries may cause damage to the device.
  • Dnot mix different types of batteries together (e.g. Alkaline and Carbon-zinc or rechargeable batteries) or old batteries with fresh ones. Always replace batteries as a simultaneous set.
  • If the batteries in the device are depleted or the device will not be used for a long period of time, remove the batteries to prevent damage or injury from possible battery leakage.
  • Dnot try to recharge batteries not intended to be recharged; they can overheat and rupture (follow battery manufacturer's directions).
  • Do not dispose of batteries in fire, batteries may explode or leak.

  • Scan the battery contacts and also those of the device prior to battery installation.

  • Remove discharged batteries from the product and dispose/recycle in compliance with all applicable laws.
  • Keep batteries away from children and pets. Batteries may be harmful if swallowed. Should a child or pet swallow a battery, seek medical assistance immediately.

2. Important information

BEURER EM 34 - Important information - 1

Signs and symbols

The following symbols are used in these instructions for use, on the packaging and on the type plate for the device and accessories:

!Caution
iNote Note on important information
Follow instructions for use
Type BF applied part (cuff only)
---Direct current
JKeep dry
Pacemaker
SNSerial number
Operating 41° F (55° C) 30 %Operating conditions 14 °F
Storage 14° F (-10° C) 10 %Storage conditions 90 °F

3. Parts and Controls

BEURER EM 34 - Parts and Controls - 1

  1. Hook and Loop Strap
  2. Rubber Electrode
  3. Rubber Electrode Covers
  4. Power Wire Connectors
  5. Power Wire

BEURER EM 34 - Parts and Controls - 2

6.▲Button (increases intensity)
7. Power Wire Jack
8. On/Off Button
9. Button (decreases intensity)
10. Intensity Level Indicators
11. Illuminated Logo
12. Clip
13. Battery Compartment Cover

4. Introduction

The Knee and elbow TENS is a single-channel TENS device and falls into the category of electrostimulation units. Gentle electrical pulses are sent via water contact electrodes through the skin to the nerve fibers. The innovative Knee and elbow TENS provides temporary pain relief in the knee and elbow area.

TENS, or transcutaneous electrical nerve stimulation, relates to the electrical stimulation of the nerves via the skin. TENS is an effective nonpharmacological method of treating different types of pain that have 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-relieving or pain-suppressing effect is achieved by inhibiting the transference of pain to nerve fibers (caused mainly by high-frequency impulses) and by increasing the secretion of endorphins in the body. Their effect on the central nervous system reduces the sensation of pain. The method is scientifically substantiated and approved as a form of medical treatment.

Any symptoms that could be relieved using TENS must be checked by your doctor. Your doctor will also give you in

strictions on how to carry out a TENS self-treatment regime.

The device is designed to be used for temporary relief for sore and aching muscles in the upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household and working activities.

5. Package Contents

1 x knee and elbow universal cuff
1 x control unit
1 x connection cable
3 x 1.5 V AAA battery LR03

6. To Use

Battery Installation/Replacement

  1. Remove the Battery Compartment Cover from the bottom of the control unit.
  2. Insert three AAA size alkaline batteries (included), observing the correct polarity as indicated inside the battery compartment.
  3. Reattach the Battery Compartment Cover.

Connecting Components

  1. Snap the ends of the power wire onto the power wire connectors on the cuff. The two ends are interchangeable and do not have a specific left or right.
  2. Moisten the rubber electrode covers with water, as well as the area on your body to be treated.
  3. Place the cuff around your knee or elbow, as desired. Ensure the rubber electrode covers are properly positioned over the desired treatment area and the opening in the cuff is over your knee/elbow.
  4. Tighten and secure the hook and loop straps.
  5. Insert the power wire plug into the power wire jack on the control unit.

BEURER EM 34 - Connecting Components - 1

BEURER EM 34 - Connecting Components - 2

BEURER EM 34 - Connecting Components - 3

BEURER EM 34 - Connecting Components - 4

  1. Press the On/Off Button to switch the device on. The device will beep three times and the logo will flash and then illuminate.
  2. Use the / buttons to select an intensity level from 1 - 25 that feels most comfortable. The "low" intensity indicator will flash for levels 1-8, the "middle" intensity indicator will flash for levels 9-17, and the "high" intensity indicator will flash for levels 18-25. The higher the level within each range, the faster the indicator will flash. NOTE: When setting the level, the control unit will beep once. If it beeps twice, there may not be enough water on the rubber electrode covers to conduct enough current, or the power wire is not attached properly.
  3. This device will switch between two treatment modes by itself. If you prefer one treatment mode over the other, you can manually select it by pressing the On/Off Button during treatment; the Indicator above the "M" will illuminate briefly, indicating that the manual selection mode is active. To return to auto mode, press the On/Off Button again; the indicator above the "A" will illuminate briefly.
  4. To shut the device off at any time, press and hold the On/Off Button until the control unit emits one long beep and the logo shuts off. It will also shut off by itself after 30 minutes of use.
  5. Always remove the cuff directly after treatment.

7. Care and Maintenance

BEURER EM 34 - Care and Maintenance - 1

CAUTION

  • Before cleaning, disconnect the power wire from the device and from the cuff.

Cleaning the Cuff

Clean the cuff in warm soapy water and then rinse well, making sure all soap is washed out. Pat cuff dry with a towel and then let air dry completely before use.

Storage

To store the device, first ensure it is switched off. Disconnect the power wire from the control unit and from the cuff. Place all parts back into their original packaging and store in a cool, dry place out of the reach of children.

  1. Troubleshooting Guide
Problem Possible cause Solution
The device does not switch onBatteries are depletedReplace the batteries
Batteries are not inserted correctlyReinsert the batteries according to the polarity indicators inside the battery compartment
The elec-trical pulses are weakCuff is not contacting skin prop-erlyReposition the cuff to ensure it contacts the skin sufficiently
Electrodes are not wet enoughShut off the device and remoisten electrodes
Treatment is uncomfortablePower wire is worn or malfunctioningReplace the power wire
Electrodes are worn or malfunctioningReplace the cuff
Intensity level set too highLower intensity level
Electrodes are not wet enoughShut off the device and remoisten electrodes
Irregular stimulationPower wire mal-functioningLower intensity level and rotate the power wire plug 90°. If problem persists, replace the power wire
Stimulation is ineffectiveElectrodes positioned incorrectlyRemove electrodes and repos-sition, ensuring cuff has sufficient skin contact
The skin turns red and/or a stabbing pain occursThe universal cuff is not positioned correctly on the skinEnsure that the universal cuff sits comfortably on the skin and cannot move
The universal cuff is dirtyClean the universal cuff as described in these ins- truc-tions for use
One of the water contact elec- trodes has a scratchReplace the uni- versal cuff
Water contact electrodes are not sufficiently moistSwitch off the de- vice. Moisten elec- trodes
Treatment stops pre-maturelyCuff has become too looseStop treatment and retighten/re-position cuff
Power wire is looseStop treatment and reinsert power wire
Batteries are depletedReplace batteries

9. Frequently Asked Questions

When should I use this device?

Apply the cuff as soon as you feel pain in your knees/ elbows. If you begin using this device immediately, you can alleviate or even avoid chronic pain. The earlier you begin using the device, the higher the probability that pain can be alleviated.

How often should I use the device?

Do not use the device on a particular area more than three sessions per day, 30 minutes per session. Start the first treatment at low intensity until you are familiar with the device. Stop treatment as soon as the pain has receded or disappeared. If, after using the device, you experience pain

due to overexertion, stop use for two days. If you experience further pain due to overexertion, lower the intensity level during subsequent uses and reduce the treatment time.

When should I stop using the device?

Stop using the device if you feel a stabbing pain during stimulation. If you notice side-effects following use (skin irritation, reddening and burning of the skin, headache, feeling unwell), stop using the device. Stop using the device if pain does not improve after several treatments, becomes chronic or lasts for more than five days.

What type of pain should I use the device for?

The device works best to treat acute pain, meaning you can easily determine precisely where the pain is located. Acute pains are generally located in a specific area of the body and occur for less than three months. Chronic pain can occur in different parts of the body and over a period of six months or more. The device is unable to assist with chronic pain and you should consult a doctor instead.

This device cannot treat injuries or the source of pain. It is intended only to provide short-term pain relief with the aim of improving your day-to-day life.

10. Specifications

Output waveform Biphasic rectangular pulse

Pulse length 300 s

Pulse frequency 2-60Hz or 2/100Hz

Output voltage max. 90 Vpp (500 ohms)

Output current max. 180 mApp (500 ohms)

Power supply 3 × 1.5 V AAA batteries LR03

Intensity Levels 0 to 25

Operating conditions 41^ - 104^ (5^ - 40^)

at a relative humidity of 30-75%

Storage conditions 14^ - 131^ (-10^ - 55^)

at a relative humidity of 10-90%

Dimensions 3.3 × 2.8 × 1.2 in

(85× 72× 31mm)

Weight Control unit: 2.96 oz (84 g)

including batteries

Cuff: 4 oz (113 g)

The serial number can be found on the unit itself or in the battery compartment.

11. FCC Compliance Statement

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device

may not cause harmful interference; and (2) this device must accept any interference received, including interference that may cause undesirable 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 can radiate 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:

Borient 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.

Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

12. Warranty

Limited Lifetime Warranty For Original Purchaser

Your Beurer Knee and Elbow TENS Unit, Model EM34, is warranted to be free from defects in materials and workmanship for the life of the product under normal conditions of intended use and service. This warranty extends only to the original retail purchaser and does not extend to retailers or subsequent owners.

We will, at our option, repair or replace the Beurer Knee and Elbow TENS Unit, Model EM34, without additional charge, for any part or parts covered by these written warranties. No refunds will be given. Repair or replacement is our only responsibility and your only remedy under this written warranty. If replacement parts for defective materials are not available, Beurer reserves the right to make product substitutions in lieu of repair or replacement.

For warranty service contact our customer service department at 1-800-536-0366 or at info@beurer.com to provide a description of the problem. If the problem is deemed to be within the scope of the limited lifetime warranty, you will be asked to mail the product at your costs in its original package with proof of purchase, your name, address and phone number. If the problem is not deemed to be within the scope of the limited lifetime warranty, we will

provide a quotation for repair respectively replacement and return shipping fee.

This warranty does not cover damage caused by misuse or abuse; accident; the attachment of unauthorized accessory; alteration to the product; improper installation; misapplication; lack of reasonable care with respect to the product; unauthorized repairs or modifications; improper use of electrical/power supply; old worn batteries; normal wear; loss of power; dropped product; malfunction or damage of an operating part as a result of failure to comply with instructions for use or to provide manufacturer's recommended maintenance; transit damage; theft; neglect; vandalism; or environmental conditions; loss of use during the period the product is at a repair facility or otherwise awaiting parts or repair; or any other conditions whatsoever that are beyond the control of Beurer.

This warranty is void if the product is ever used in a commercial or business environment. The maximum liability of Beurer under this warranty is limited to the purchase price actually paid by the customer for the product covered by the warranty, as confirmed by proof of purchase, regardless of the amount of any other direct or indirect damage suffered by the customer.

This warranty is effective only if the product is purchased and operated in the country in which the product is pur

chased. A product that requires modifications or adaptation to enable it to operate in any other country than the country for which it was designed, manufactured, approved and/or authorized, or repair of products damaged by these modifications is not covered under this warranty.

THE WARRANTY PROVIDED HEREIN SHALL BE THE SOLE AND EXCLUSIVE WARRANTY. ANY IMPLIED WARRANTY, OBLIGATIONS, OR LIABILITES, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED IN DURATION TO THE DURATION OF THIS APPLICABLE WRITTEN WARRANTY. Some states do not allow limitations on how long an implied warranty lasts, so the above limitations may not apply to you.

IN NO EVENT SHALL BEURER BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES FOR BREACH OF THIS OR ANY OTHER WARRANTY, EXPRESS, IMPLIED OR ANY OTHER THEORY OF LIABILITY, WHATSOEVER. Some states do not allow the exclusion or limitation of special, incidental, or consequential damages, so the above limitation may not apply to you.

Distributed by:

Beurer North America, LP

900 N Federal Hwy, Ste 300

Hallandale Beach, FL 33009 USA

Made in China.

ESPANOL

Contenido

Beurer North America LP

900 N Federal Hwy, Suite 300

Hallandale Beach, FL 33009. Estados Unidos

www.beurer.com

Hecho en China.

FRANÇAIS

Table des matieres

  1. REMARQUES IMPORTANTES SUR LA SECURITE .. 32
  2. Informations importantes 37
    3.Pieces et commandes 38
  3. Introduction 39
    5.Contenu de I'emballage 39
  4. Utilisation 40

1. REMARQUES IMPORTANTES SUR LA SECURITÉ

Signes et symboles

Beurer North America, LP

900 N Federal Hwy, Ste 300

Hallandale Beach, FL 33009 USA

Fabrique en Chine.

Electromagnetic Compatibility Information

Table 1

For all me equipment and me systems

The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided.
- Portable and mobile RF communications equipment can affect device.
- The use of accessories or replacement parts, other than those sold/specified by the manufacturer may result in increased emissions or decreased immunity of the device.
- The device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.

Guidance and manufacture's declaration - electromagnetic emissions

EM34 is intended for use in the electromagnetic environment specified below. The customer or the user of EM34 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1EM34 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 BEM34 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2 Not applicable
Voltage fluctuations/flicker emissions IEC 61000-3-3Not applicable

Table 2 For all me equipment and me systems Guidance and manufacturer's declaration - electromagnetic immunity

Guidance and manufacturer's declaration - electromagnetic immunity
EM34 is intended for use in the electromagnetic environment specified below. The customer or the user of EM34 should assure that it is used in such an environment.
Immunity test IEC 60601 testlevel Compliance level Electromagnetic environment - guidance
Electrostatic discharge (ESD)IEC 61000-4-2± 6 kV contact± 8 kV air± 6 kV contact± 8 kV airFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic materi-al, the relative humidity should be at least 30 %.
Electrical fast transient/burstIEC 61000-4-4± 2 kV for power supply lines± 1 kV input/output linesNot applicableMains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5± 1 kV differential mode± 2 kV common modeNot applicableMains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interrup-tions and voltage variations on power supply input lines IEC 61000-4-11<5% U_T (> 95 % dip in U)for 0,5 cycle40% U_T (60 % dip in U)for 5 cycles70% U_T (30 % dip in U)for 25 cycles<5% U_T (> 95 % dip in U)for 5 secNot applicableMains power quality should be that of a typical commercial or hospital environment. If the user of EM34 requires continued operation during power mains interruptions, it is recommended that EM34 is be powered from an uninterrupti-ble power supply or a battery.
Power frequency (50/ 60 Hz)magnetic field IEC 61000-4-83 A/m 3 A/mPower frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTICE: U_t is the a.c. mains voltage prior to application of the test level.

Table 3 For all me equipment and me systems that are not life-supporting Guidance and manufacturer's declaration - electromagnetic immunity

Guidance and manufacturer's declaration - electromagnetic immunity
EM34 is intended for use in the electromagnetic environment specified below. The customer or the user of EM34 should assure that it is used in such an environment.
Immunity testIEC 60601 test levelCompliance levelElectromagnetic environment - guidance
Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3Not applicable3V/m80 MHz to2,5 GHz3V/mPortable and mobile RF communications equipment should be used no closer to any part of EM34, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distance:d=1,2√Pd=1,2√80 MHz to 800 MHzd=2,3√P800 MHz to 2,5 GHzWhere 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 metres (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range.bInterference may occur in the vicinity of equipment marked with the following symbol:
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.

Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radios 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 EM34 is used exceeds the applicable RF compliance level above, EM34 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating EM34.
b Over the frequency range 150kHz to 80MHz , field strengths should be less than 3 V/m.

Table 4
For all me equipment and me systems that are not life-supporting
Recommended separation distances between portable and mobile RF communications equipment and EM34

Recommended separation distances between portable and mobile RF communications equipment and EM34
EM34 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of EM34 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and EM34 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)
150 kHz to 80 MHzd=1,2 √P80 MHz to 800 MHzd=1,2 √P800 MHz to 2,5 GHzd=2,3 √P
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
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 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 reflection from structures, objects and people.
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Product information

Brand : BEURER

Model : EM 34

Category : Pain therapy device