TL 35 - Lamp BEURER - Free user manual and instructions

USER MANUAL TL 35 BEURER

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 specified Customer Services address.

1 set of 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: DANGER Indicates an imminent danger. If it is not avoided, it will result in death or serious injury. 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. NOTICE Indicates a potentially harmful situation. If it is not avoided, the system or something in its vicinity may be damaged.

1. Included in delivery ........................................16

4. Warnings and safety notes ............................. 19

9. Accessories and replacement parts ............... 24

10. What if there are problems? .........................24

ENGLISH CONTENTS16 17 Product information Note on important information Observe the instructions Read the instructions before starting work and/or operating devices or machines Disposal in accordance with the Waste Electrical and Electronic Equipment EC Directive (WEEE) CE labelling This product satisfies the requirements of the applicable European and national directives. Manufacturer UDI Unique device identifier (UDI) Identifier for unique product identification Dispose of packaging in an environmentally friendly manner Separate the product and 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 Protection class II device The device is double-insulated and, therefore, is in protection class 2 On/O Storage Permissible storage temperature and humidity Medical device Operating Permissible operating temperature and humidity Article number Date of manufacture IP21 Protected against solid foreign objects 12.5 mm in diameter and larger, and against vertically falling drops of water For indoor use only Atmospheric pressure limitation Serial number Batch designation Direct current The device is suitable for use with direct current only EC REP Authorised representative in the European Community REPCH Swiss Authorised Representative Importer symbol Type18

Purpose The daylight therapy lamp is intended to compensate the eects of lack of light, particularly sunlight, and provide relief from winter seasonal aective disorders, mood disorders and circadian phase sleep disorders. Patient population For adults and children over the age of 3 years. Intended users The use of the device does not require a specific knowledge or professional ability. The patient is the intended operator, except for patients who require special assistance. Indication The device simulates daylight to provide relief from seasonal or mood disorders. Contraindication Do not use in case of people insensitive to heat, people with skin lesions due to illness, people with a condition that might render his or her eyes more vulnerable to phototoxicity, people with a photosensitive skin condition, patient is taking a photosensitizing medication or herb. Why use a daylight therapy lamp? When the hours of daylight are noticeably shorter in autumn and people increasingly stay inside in winter, the eects of a lack of light may become apparent. This is often described as “winter depression”. The symptoms can present themselves in a number of ways:

Lack of energy and listlessness

Diculty concentrating

Generally feeling under the weather The cause of these symptoms is the fact that light – particularly sunlight – is essential for life and has a direct eect upon the human body. Sunlight indirectly controls the production of melatonin, which is passed to the blood only in darkness. This hormone shows your body that it’s time to sleep. That’s why more melatonin is produced in months with less sunshine, making it dicult to get up in the mornings because your body functions are powered down. Use the daylight therapy lamp immediately after waking up (i.e. as early as possible) to end the production of melatonin and to brighten your mood. Lack of light also prevents the production of the happy hormone serotonin, which is said to significantly influence our well-being. The application of light thus yields quantitative changes to hormones and neurotransmitters in the brain that have an eect on our activity levels, our feelings and our well-being. To compensate for such a hormonal imbalance, daylight therapy lamps can create a suitable replacement for natural sunlight. In the medical field, daylight therapy lamps are used to combat the eects of a lack of light. Daylight therapy lamps simulate daylight over 10,000 lux. This light can influence the human body and be used as a treatment or as a preventative measure. Normal electric light, however, is not sucient to influence the hormonal balance. This is because in a well-lit oce, the light intensity is just 500 lux, for example.18 19

The daylight therapy lamp is only intended for the use on the human body.

Before use, ensure that all packaging materials are removed and that there is no visible damage to the device or accessories. When in doubt, do not use the device and contact your retailer or the specified Customer Service address.

This equipment is not intended for use by children and persons with reduced physical, sensory and mental capabilities, or lack of experience and knowledge, unless they have been given supervision or instruction concerning use of the equipment to ensure that they do not play with the equipment and to avoid the risk of fire and burns.

Ensure that the daylight therapy lamp has a firm footing.

Connect the device only to the mains voltage listed on the type plate.

Check if the voltage indicated on the equipment corresponds to the local mains voltage before you connect the equipment to avoid risk of electrocution or permanent damage to the equipment.

Do not dip the device into water and do not use it in wet rooms.

Keep children away from packaging materials (risk of suocation!).

Do not cover up or pack away the device while it is warm.

Always unplug the mains adapter and allow the device to cool down before touching it.

Always unplug the appliance after use and in case of a power failure to avoid risk of damage to the equipment.

Do not touch the device with wet hands while it is plugged in and do not allow any water to be sprayed onto the device. The device must be operated only when it is completely dry.

Ensure that you only insert and remove the mains adapter with dry hands and that you only press the ON/OFF button with dry hands.

Keep the mains cable away from hot objects and naked flames.

Protect the device from strong impacts.

Do not use the device if it shows signs of damage or does not function properly. In these cases, contact Customer Services.

If the mains connection cable of this device is damaged, it must be disposed of. If it cannot be removed, the device must be disposed of.

Disconnection from the power supply network is only guaranteed when the mains adapter is unplugged.

Do not use the device in the presence of flammable anaesthetic gas connections with air, oxygen or nitrogen oxide.

Do not leave the device unattended when it is switched on to avoid the risk of fire or burns.

If the wall socket used to power the device has poor connections, the plug of the device becomes hot. Make sure you plug the device into a properly installed wall socket to avoid the risk of fire and burns.

Do not subject the device to heavy shocks to avoid risk of damage to the lamp.

Water and electricity are a dangerous combination! To avoid risk of electrocution:

Do not use this equipment in wet surroundings (e.g. in the bathroom or near a shower or swimming pool);

Do not let water run into the appliance.

No calibration and no preventive checks or maintenance need to be carried out on this device.

You cannot repair the device. The device contains no parts that you can repair.

Do not make any changes to the device without the manufacturer’s permission.

If the device has been changed, thorough tests and checks must be carried out to ensure the continued safety of the device for any future use.

To avoid strangulation and entanglement, keep cable out of reach of young children.

The patient is an intended operator. The patient can use the device and its accessories according to this manual.20 21 General notes IMPORTANT

Always consult a doctor before using the daylight therapy lamp if you are taking medication such as pain relief medication, medication to reduce high blood pressure or antidepressant medication.

Diabetics and people who suer from retinal diseases must be examined by an optician before using the daylight therapy lamp.

Do not use the device if you suer from an eye disease such as cataracts, glaucoma, diseases of the optic nerve or inflammation of the vitreous body.

Always consult a doctor before using the daylight therapy lamp if you have a strong sensitivity to light, your skin is sensitive to light or you are prone to migraine attacks.

If you have health concerns of any kind, consult your general practitioner!

Remove all packaging material before using the device.

Light sources are excluded from the warranty.

If the device has been in storage or recently transported, allow it to rest for at least two hours at room temperature before using it.

The mains adapter is part of the ME equipment.

Check whether light flashes, dark areas/shadows and other abnormalities occur after power-on. If there is any abnormality, please contact Customer Services or an authorised retailer.

The patient cannot undergo an MRI scan while using this device.

Report any serious incident that has occurred in relation to the device to the local competent authority and the manufacturer or European Authorised Representative (EC REP) Vigilance Contact Point: https://EC.europa.eu/growth/sectors/medical-devices/contacts.

PRC is the abbreviation for the People’s Republic of China. Instructions for repairs IMPORTANT

Do not open the device. Do not attempt to repair the device yourself. This could result in serious injury. Failure to comply will invalidate the warranty.

For repairs, please contact Customer Services or an authorised retailer.21

5. DEVICE DESCRIPTION

The associated drawings are shown on page 3.

Brightness button (dimmer)

Mains adapter connector

Take the device out of the plastic wrapping. Check the device for damage or faults. If you notice any damage or faults on the device, do not use it and contact Customer Services or your supplier. Setting up the device Place the device on a level surface. The position should be chosen to ensure a distance of between 13 cm and 35 cm between the user and the device. The lamp is most eective at this distance. Mains adapter connector

To prevent possible damage to the device, the daylight therapy lamp must only be used with the mains adapter described here.

Insert the mains adapter into the connector provided for this purpose on the rear of the daylight therapy lamp. The mains adapter must only be connected to the mains voltage that is specified on the type plate.

After using the daylight therapy lamp, unplug the mains adapter from the mains socket first and then disconnect it from the daylight therapy lamp. IMPORTANT

Ensure that there is a mains socket close to the set-up area.

Arrange the mains cable so that no-one will trip over it.22

Connect the mains adapter to the mains adapter connection on the rear of the daylight therapy lamp. Plug the mains adapter into a suitable socket. 2 Switching on the daylight therapy lamp To switch on the daylight therapy lamp, touch the ON / OFF / TIMER button

for 2 seconds. The fluorescent screen starts to light up

(colour temperature Therapy at highest setting). The next time the device is switched on, it is restarted with the colour temperature Therapy (fluorescent screen lights up cool white at the highest setting). 3 Selecting the colour temperature The TL 35 daylight therapy lamp features three adjustable colour temperatures (Therapy, Active and Relax) and thus enables various applications for regulating the day-night rhythm or it can be used in a targeted manner in order to support the phases of concentration, therapy and relaxation.

To switch between the individual colour temperatures, briefly press the colour temperature button

with the daylight therapy lamp switched on. Therapy = 6500 Kelvin (fluorescent screen lights up cool white) Active = 4300 Kelvin (fluorescent screen lights up neutral white) Relax = 3000 Kelvin (fluorescent screen lights up warm white) We recommend the following two applications: Imitation of a sunny day Programme Start of application Relax 6 am Active 10 am Therapy 12 pm Active 2 pm Relax 8 pm Optimum light during a work day Programme Start of application Therapy 6 am Active 8 am Relax 12 pm Active 1 pm Relax 8 pm 4 Setting the timer The TL 35 daylight therapy lamp indicates your current treatment time using 4 LEDs. The treatment time can be set at the following 4 levels. The timer function will not be active when the lamp is switched on for the first time. The lamp now shines until it is switched o again.

to select the desired level from 1–4. Level 1 sets a treatment time of 30 minutes. The other levels are as follows: Treatment time Level (number of lit LEDs) 30 minutes 1 60 minutes 2 90 minutes 3 120 minutes 4 The lamp switches o automatically after this treatment time, steadily becoming darker.

repeatedly until the LEDs go out.23 5 Adjusting the brightness The TL 35 daylight therapy lamp has 4 brightness levels. The set brightness level should be comfortable for the eye throughout the treatment. Select your desired brightness level using the brightness button (dimmer)

The device can also be used as a reading lamp from the following brightness levels: Programme Brightness level Therapy from brightness level 1 Active from brightness level 2 Relax from brightness level 3 6 Therapy setting - Enjoying the light Position yourself as close as possible to the lamp, at a distance of between 13 cm and 35 cm. You can continue to go about your day-to-day activities during the treatment, including reading, writing, making telephone calls, etc.

Keep looking directly into the light for a short period of time, as it is absorbed and shows an eect via the eyes/retina.

Use the daylight therapy lamp as often as you want. However, the treatment is most eective if you carry out the light therapy for at least 7 successive days according to the prescribed times.

The most eective time of day for the treatment is between 6 am and 8 pm, and we recommend that you use the device for 2 hours per day.

However, do not look directly into the light for the entire treatment time, as this may cause over-stimulation of the retina.

Start with a brief treatment time and gradually increase the time over the course of a week. You may experience pain in the eyes and headaches after the first few applications. This pain should disappear in further sessions as the nervous system becomes accustomed to the new stimuli. 7 Therapy setting - Things to consider We recommend a distance of between 13 cm and 35 cm from the face to the daylight therapy lamp during application. The treatment time depends on the distance: Lux Distance Application duration 10,000 approx. 13 cm 0.5 hours 5,000 approx. 20 cm 1 hour 2,500 approx. 35 cm 2 hours In principle: The closer you are to the light source, the shorter the treatment time. 8 Enjoying the light over longer periods Repeat the treatment on at least 7 consecutive days during darker periods of the year, or for longer depending on your individual needs. The treatment should take place during the mornings where possible. 9 Switching o the daylight therapy lamp To switch o the daylight therapy lamp, press and hold the ON / OFF / TIMER button

for 2seconds. The LEDs switch o. Unplug the mains adapter from the mains socket. IMPORTANT The daylight therapy lamp remains hot after use. Allow the daylight therapy lamp to cool down before putting it away and/or packing it away.24

8. CLEANING AND MAINTENANCE

The device should be cleaned from time to time. IMPORTANT

Ensure that no water gets inside the device! The device must be switched o, disconnected from the mains and allowed to cool down each time before cleaning.

Do not clean the device in the dishwasher. Use a slightly damp cloth to clean the device.

Do not use any abrasive cleaning products and never submerge the device in water. Do not touch the device with wet hands when it is plugged in and do not allow water to spray on the device. Only operate the device if it is completely dry. Storage If you are not going to use the device for an extended period of time, disconnect it and store it in a dry place, out of the reach of children. Follow the storage instructions provided in the “Technical specifications” chapter.

9. ACCESSORIES AND REPLACEMENT PARTS

To purchase accessories and replacement parts, please visit www.beurer.com or contact the corresponding service address (according to the service address list) in your country. Accessories and replacement parts are also available from retailers. Designation Article number Stand 110.034 Mains adapter 110.035

10. WHAT IF THERE ARE PROBLEMS?

Problem Possible cause Solution Device does not light up Device is switched o. Touch the ON / OFF / TIMER button

No power Connect the mains adapter correctly to a suitable socket. No power The mains adapter is faulty. Contact Customer Services or your retailer LEDs have reached the end of their service life. LEDs faulty For repairs, please contact Customer Services or an authorised retailer.

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. Observe the local regulations for material disposal. 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. You can obtain the location of collection points for old devices from the local or municipal authorities, local waste disposal companies or your retailer, for example.24 25 Component Disposal Photo Device The components consist mainly of PC, ABS, PMMA and aluminium. All components comply with RoHS and REACH directives and can be disposed of safely. Stand The stands consists mainly of ABS and TPE. All components comply with RoHS and REACH directives and can be disposed of safely. Mains adapter The adapter mainly contains plastic and elec- tronic components. All components comply with RoHS and REACH directives and can be disposed of safely.

12. TECHNICAL SPECIFICATIONS

Type GCE506 Model no. TL 35 Dimensions (width x height x depth) 155 x 83 x 25 mm Weight Approx. 520 g Light LEDs , CRI: min. 90 Power output 15 W max. Light intensity Therapy 10,000 lux (at a distance of approx. 13 cm) 6500 K Active 7,000 lux (at a distance of approx. 10 cm) 4300 K Relax 3,000 lux (at a distance of approx. 20 cm) 3000 K Radiation Radiance output outside of the visible range (infrared and UV) is low enough that no eye or skin damage is anticipated. Operating conditions 0°C to +35°C, 15 – 90% relative humidity, 700 – 1060 hPa ambient pressure Transport and storage conditions -20°C to +60°C, 15 – 90% relative humidity, 700 – 1060 hPa ambient pressure Light wavelength Therapy 435–680 nm Product classification External power supply, IP21 Colour temperature of LEDs Therapy 6500 K ± 400 K Active 4300 K ± 400 K Relax 3000 K ± 400 K Expected service life of the device 10,000 hours26 Subject to errors and changes Mains adapter Model no. MP12M-120150-AG Input 100-240 V AC, 50/60 Hz , 0.5 A max. Output 12 V DC, 1.5 A max. Polarity of the DC voltage connection Classification Protection class II Maximum radiance output of the TL 35 Radiance output Risk group classified in accordance with

Maximum value “Therapy” Euva: Eye UV-A Exempt Group 0.00007 W·m-2 ES: Actinic UV skin & eye Exempt Group 0.00011 W·m-2 EIR: Infrared radiation hazard exposure limits for the eyes Exempt Group 0.00409 W·m-2 LIR: Retinal thermal N/A N/A LB: Blue light Exempt Group 59.63 W·m-2·sr-1 LR: Retinal thermal Exempt Group 63.22 W·m-2·sr-1 Subject to technical changes. The serial number is located on the device. Brightness: 10,000 lux (this point about the light intensity is merely for information purposes. With regard to the standard 60601-2-83, this light source is classified as an Exempt Group). Notes on electromagnetic compatibility The device complies with the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices as well as the European standard EN 60601-1-2 (in accordance with CISPR11, IEC61000-3-2, IEC61000-3-3, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC61000-4-6, IEC 61000-4-11, IEC 61000-4-8) and is subject to particular precautions with regard to electromagnetic compatibility.

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.

Failure to comply with the above could impair the performance of the device.

torizado (REP): https://EC.europa.eu/growth/sectors/medical-devices/contacts.