BR 60 - Pain therapy device BEURER - Free user manual and instructions

USER MANUAL BR 60 BEURER

1. Included in delivery .......................37

4. Warnings and safety notes ............44

8. Cleaning and maintenance ...........56

9. What if there are problems? ..........57

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 and that all packaging material has been removed. In case of any doubt, do not use the device, and contact your retailer or the specified Customer Service address. 1 x BR 60 2 x batteries, type AAA (LR03 1.5 V) 1 x instructions for use

2. SIGNS AND SYMBOLS

The following symbols are used on the device, in these instructions for use, on the packaging and on the type plate for the device:38 WARNING Indicates a potentially impending danger. If it is not avoided, there is a risk of death or serious injury. CAUTION Indicates a potentially impending danger. If it is not avoided, slight or minor injuries may result. Product information Note on important information Observe the instructions Read the instructions before starting work and/or operating devices or machines Type BF applied part39

The electronic device must not be disposed of with household waste Do not dispose of batteries containing harmful substances with hou- sehold waste Manufacturer

Serial number IP42 Device protected against solid foreign objects ≥ 1mm in diameter and larger, and against drops of water when the housing is angled up to 15°40 Temperature limit Humidity limitation CE labelling This product satisfies the requirements of the applicable European and national directives. Medical device Separate the product and packaging elements and dispose of them in accordance with local regulations.

Marking to identify the packaging material. A = Material code, B = Material number: 1-7 = Plastics, 20-22 = Paper and cardboard41 Importer symbol UDI Unique Device Identifier (UDI) for unique product identification Item number Type number Date of manufacture Batch code Swiss authorised representative Separate the product and packaging elements and dispose of them in accordance with local regulations.42

Intended use The insect bite healer is intended for relieving itching and swelling caused by insect bites or stings by applying heat (local hyperthermia). Target group The insect bite healer is intended for use in the home healthcare environment, not in professional healthcare facilities. The insect bite healer can be used on anyone over 3 years of age under supervision; can be used for self-treatment by anyone over 12 years of age. Clinical benefits Treatment and relief of itching and swelling caused by insect bites or stings. Indication Treatment with the insect bite healer is recommended for: - itching - swelling caused by insect bites or stings.43 CONTRAINDICATIONS WARNING

• Do not use the device if you suer from diabetes. Sensitivity to pain could, in certain circumstances, be reduced and diabetics may burn themselves.

• Do not use the device on people with disabilities, children under 3 years old or people with reduced sensitivity to heat. This includes people with skin alterations due to illness or scarred tissue in the application area, after taking pain relief medication, drinking alcohol or taking drugs.

• Do not use the device on acutely or chronically diseased (injured or irritated) skin (e.g. inflamed skin, whether painful or not, reddened skin, rashes, (e.g. allergies), burns, frostbite, bruises, swellings (without signs of an insect bite/ sting), open/bleeding and healing wounds, and surgical scars where the healing process could be aected).

• Do not use the device if you are suering from a fever.

• Do not use the device on sensitive areas of skin.44

• Do not use the device if you have any sensory impairment that reduces the feeling of pain (e.g. metabolic disorders).

• Do not use the device if you are using lotions, creams and gels locally at the same time.

• Do not use the device if you suer from persistently irritated skin due to long- term heat application on the same area of skin.

• Any person using it on themselves must be over 12 years old. The product should only be used on children under 12 years old if supervised or assisted by an adult.

• Before using the device, consult your doctor if you have any skin conditions, serious illness (in particular if you have a propensity to thromboembolic45 conditions or recurrent malignant growths), unexplained chronic pain in any part of the body.

• Seek medical advice immediately if the symptoms persist despite using the insect bite healer and stop using it.

• Seek medical advice immediately if the symptoms worsen whilst or after using the insect bite healer and stop using it.

• Seek medical advice immediately if it is a tick bite. The bite may result in transmission of pathogens such as tick-borne encephalitis (TBE) or borrelio- sis.

• Seek medical advice immediately if the first signs of increased itching, skin redness, swelling, dizziness, nausea, shortness of breath, formation of wheals or a drop or increase in blood pressure occur.

• Do not use near to the eyes, on the eyelids, mouth or on mucous membranes.

• Do not allow children to play with the device.

• Store the device out of the reach of children and pets.

• Keep packaging material away from children (risk of suocation).

• Please note the general hygiene measures when using the insect bite healer.46

• The device is not a substitute for medical consultation and treatment. Always consult your doctor if you are experiencing any pain or are suering from an illness.

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

• Do not touch the device with wet hands. Do not allow water to spray onto the device. Only operate the device if it is completely dry.

• Do not use any detergents or solvents to clean and maintain the device. If liquid penetrates the device this could cause damage to the electronics or other device parts and lead to a malfunction.

• The device should only be used by one person; use by multiple people is not recommended.

• Protect the device against direct sunlight and store in a dry place.47

• Protect the device from impacts, moisture, dust, chemicals, marked tempera- ture fluctuations and nearby sources of heat (ovens, heaters).

• Ensure that no water enters the device. If this should happen, remove the batteries and only use the device again when it is completely dry.

• If you store the device, no heavy objects should be placed on top of it.

• Before use, ensure that there is no visible damage to the device. In case of any doubt, do not use the device, and contact your retailer or the specified Customer Service address.

• Store the device in a location protected against climatic influences. The device must be stored in the environmental conditions specified.

• Do not leave the device unattended while in use. If the device malfunctions, switch it o and stop using it.48

• Risk of explosion! Risk of fire! Failure to comply with the following points can result in personal injury or cause overheating, leakage, venting, breakage, explosion, or fire on the battery.

• This device contains non-rechargeable batteries which must not be charged.

• Do not throw batteries into a fire.

• Never charge, forcibly discharge, heat, disassemble, open, crush, deform, encapsulate, or modify batteries.

• Never short-circuit batteries or battery compartment contacts.

• Protect the batteries from direct sunlight, rain, heat, and water.

• Exposure of batteries to an environment with extremely high temperatures or an extremely low air pressure may result in explosion or leakage of flammable liquids and gases.

• Dispose of defective and discharged batteries immediately and properly (see chapter on disposal).49

• Do not use modified or damaged batteries.

• Always select the correct battery type.

• Always insert the batteries correctly, taking into account the polarity (+ / -).

• Never mix batteries of dierent manufacturers, capacities (new and used), size, or type within a device.

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

• If fluid from a battery comes into contact with your skin or eyes, wash the aected areas with water and seek medical assistance.

• Choking hazard! Keep batteries out of the reach of children. Seek medical attention immediately if swallowed. Swallowing them may cause burns, severe internal injuries, and death.

• Never allow children to replace batteries without adult supervision. CAUTION

• Store batteries in a well-ventilated, dry, and cool place in a non-conductive container in which the batteries cannot be short-circuited to each other or by other metal objects.50

• Keep batteries clean and dry.

• Keep batteries away from water.

• If the device is not going to be used for a long period of time, remove the batteries from the battery compartment. NOTICE

• Do not use rechargeable batteries.

• The device is suitable for use in all environments listed in these instructions for use, including domestic environments.

• The use of the device may be limited in the presence of electromagnetic disturbances. This could result in issues such as error messages or the failure of the device.51

• Avoid using this device directly next to other devices or stacked on top of ot- her devices, as this could lead to faulty operation. If, however, it is necessary to use the device in the manner stated above, 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 manu- facturer 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.52

5. DEVICE DESCRIPTION

The associated drawings are shown on page 3.

Battery compartment lid

1. Push open the battery compartment lid

2. Insert the batteries included in delivery into the battery compartment as shown

inside the battery compartment. When inserting the batteries, ensure that the correct polarity (+/-) is observed.

3. Slide the battery compartment lid

closed until you feel and hear it click into place.53

WARNING Before use, make sure that there is no insect sting remaining in the area that was stung. Remove the sting carefully before use. To achieve the best results, use the device immediately after the insect bite or sting. If you wait too long to treat the area that has been stung or bitten and itching and swelling have already started, the insect bite healer can only have a limited eect. Nevertheless, treat the area with the insect bite healer. Usually, itching can be relieved and healing can be sped up. CAUTION Depending on the sensitivity of the person using the device and of the area of skin, the treatment temperature may feel unpleasant and cause slight skin redness and, in rare cases, irritated skin. If the heat function feels too hot, stop treatment immediately!54

1. To switch on the device, slide the ON/OFF control

to the “I” position in the direction of the heating plate. ➔ Device status LED

starts to light up blue. Device is now ready for use.

Place the heating plate

of the device on the area that has been stung or bitten.

You can choose between 2 dierent treatment times (3 or 6 seconds) depending on how sensitive your skin is. The 3-second treatment is recommended for first use or use on sensitive skin. - To use the 3-second treatment, briefly press the activation button

once. ➔ One half of the blue illuminated ring

lights up and the treatment starts. - To use the 6-second treatment, briefly press the activation button

two times in a row. ➔ The entire blue illuminated ring

for more than 2 seconds, the emergency switch-o will be activated. To use the device again after the automatic switch-o, switch the device back to “OFF” using the ON/ OFF control

. This is indicated by the “O” symbol. The blue device status LED

4. An acoustic signal sounds at the end of the treatment.

➔ The blue illuminated ring

goes out and the heating plate

stops providing heat.

To prolong the battery life, switch o the device each time after using it. To switch o the device, slide the ON/OFF control

to the “O” position. If you do not actively switch o the device yourself, the automatic switch-o function will switch it o automatically after 2 minutes. To use the device again after the automatic switch-o, switch the device back to “OFF” using the ON/OFF control

. This is indicated by the “O” symbol. The blue device status LED

turns o.56 Battery warning Before the battery level becomes too low for other applications, the device status LED

starts to flash 3x and an acoustic signal sounds 3x. Replace both batte- ries soon, as described in section 6.

8. CLEANING AND MAINTENANCE

Observe the following hygiene instructions to avoid health risks:

• The device is intended for multiple uses.

• It is recommended that the device is cleaned before first use and each ad- ditional use.

• The device must be switched o, allowed to cool down and the batteries removed each time before cleaning.

• Use only soft, dry cloths for cleaning the housing.

• Never use any substances for cleaning that could potentially be toxic if they came into contact with the skin or mucous membranes, or if they were swallowed or inhaled. Do not use any abrasive cleaning products and never submerge the device in water.

• Do not clean the device in the dishwasher!57

• Avoid mechanical cleaning with brushes or similar, as this could result in irreparable damage.

• When using the device on multiple areas that have been stung and bitten, it is recommended that you clean the heating plate each time. This reduces the possibility of germs and bacteria being transferred from one area of skin to the next. To disinfect the heating plate, use a cotton bud moistened with disinfectant.

9. WHAT IF THERE ARE PROBLEMS?

Problem Possible cause Solution The device does not switch on. The ON/OFF switch

is in the OFF position. Slide the ON/OFF switch

into the ON position. The batteries are flat. Replace both batteries as described in these instructions for use.58 Problem Possible cause Solution The device no longer gets hot enough. The battery level is too low. Replace both batteries as described in these instructions for use. Device outputs 3acoustic signals/ thedevice status LED

flashes – even after switching the device OFF and ON again. Battery level is too low, meaning that the device may no longer be able to be operated. Replace both batteries as described in these instructions for use.59 Problem Possible cause Solution Application cannot be started, even though the ON/OFF switch

is set to ON. Device has switched o automatically. Either the activation button was pressed for more than 2 seconds or it was not used for more than 2 minutes and the automatic switch-o was activated. First switch the device to OFF using the ON/OFF switch

and then switch it on again as usual. The device does not switch on, even though the batteries have been replaced and the ON/OFF switch

has been set to ON. The device may be faulty. Please contact Customer Services.60 Problem Possible cause Solution Device outputs 5acoustic signals and the illuminated ring

flashes. This indicates a potential malfunction. Switch the device o and repeat the application again after 10minutes. Please contact Customer Services if the fault occurs again.

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.61 Batteries must not be disposed of in the household waste. They may contain poisonous heavy metals and are subject to special refuse treatment.The codes below are printed on batteries containing harmful substances: Pb = battery contains lead, Cd = battery contains cadmium Hg = battery contains mercury

11. TECHNICAL SPECIFICATIONS

Type BR 60 Dimensions (L x W x H) 98,3 x 35,5 x 20 mm Weight (with batteries) 47 g Power supply 2 x 1.5 V AAA LR03 batteries Max. temperature 50 °C ± 2 °C (122 °F ± 3.6 °F) Functions 2 time settings (3s/6s) Expected operating duration Approx. 300 applications (per batteries)62 Permissible storage and transport temperature and humidity -10 °C to 50 °C, relative humidity 30% to 85% Permissible operating temperature and humidity 10 °C to 40 °C, relative humidity 30% to 85% The serial number is located on the device or in the battery compartment. Subject to technical changes. This device conforms with the European standard EN 60601-1-2 (Group 1, Class B, in accordance with CISPR 11, CISPR 14-1, CISPR-32, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11) and is subject toparticular precautions with regard to electromagnetic compatibility.

12. WARRANTY/SERVICE

Further information on the warranty and warranty conditions can be found in the warranty leaflet supplied.63 Subject to errors and changes Notification of incidents For users/patients in the European Union and identical regulation systems, the following applies: If during or through use of the product a major incident occurs, notify the manufacturer and/or their representative of this as well as the respective national authority of the member state in which the user/patient is located.64 Lisez attentivement ce mode d’emploi, conservez-le pour un usage ultérieur, mettez-le à disposition des autres utilisateurs et suivez les consignes qui y figurent.