beurer TL 35 Daylight Therapy Lamp User Manual

beurer TL 35 Daylight Therapy Lamp

Read these instructions for use carefully. Observe the warnings and safety notes. Keep these instructions for use for future reference. Make the instructions for use accessible to other users. If the device is passed on, provide the instructions for use to the next user as well.

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 specified Customer Services address.

• 1 daylight therapy lamp
• 1 stand
• 1 mains adapter
• 1 felt bag
• 1 set of instructions for use

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.

INTENDED USE

Purpose
The daylight therapy lamp is intended to compensate for the effects of lack of light, particularly sunlight, and provide relief from winter seasonal affective 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 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 effects 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:

• Imbalance
• Subdued mood
• Lack of energy and listlessness
• Generally feeling under the weather
• Need for more sleep
• Loss of appetite
• Difficulty concentrating

The cause of these symptoms is the fact that light – particularly sunlight – is essential for life and has a direct effect on 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 difficult 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 effect 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 effects 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 sufficient to influence the hormonal balance. This is because in a well-lit office, the light intensity is just 500 lux, for example.

WARNINGS AND SAFETY NOTES

WARNING

• The daylight therapy lamp is only intended for 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 the 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 suffocation!).
• 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 the 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 main cable away from hot objects and naked flames.
• Protect the device from strong impacts.
• Do not pull the mains adapter out of the socket using the mains cable.
• 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 anesthetic 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 the risk of damage to the lamp.
• Water and electricity are a dangerous combination! To avoid the 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.

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 suffer from retinal diseases must be examined by an optician before using the daylight therapy lamp.
• Do not use the device if you suffer 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 main 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 authorized 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 authorized retailer.

DEVICE DESCRIPTION

The associated drawings.

1. Fluorescent screen
2. Colour temperature button
3. Timer display (in minutes)
4. ON / OFF / TIMER button
5. Brightness button (dimmer)
6. Stand
7. Mains adapter connector

INITIAL USE

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 effective 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 main socket close to the set-up area.
• Arrange the main cable so that no one will trip over it.

USAGE

1| 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 4 ** for 2 seconds. The fluorescent screen starts to light up 1 ** (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 2 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

Optimum light during a work day

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 off again.

1.  To set a timer, briefly touch the ON / OFF / TIMER button 4 **** to select the desired level from 1 – 4. Level 1 sets a treatment time of 30 minutes. The other levels are as follows:

The lamp switches off automatically after this treatment time, steadily becoming darker.

2.  To deactivate the timer function, briefly touch the ON / OFF / TIMER button 4 **** repeatedly until the LEDs go out.

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) 5.

The device can also be used as a reading lamp from the following brightness levels:

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 effect via the eyes/retina.

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

•  The most effective 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:

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 off the daylight therapy lamp

To switch off the daylight therapy lamp, press and hold the ON / OFF / TIMER button 4 **** for 2 seconds. The LEDs switch off. 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.

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 off, 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.

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.

WHAT IF THERE ARE PROBLEMS

button 4.
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.

DISPOSAL

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.

All components comply with RoHS and REACH directives and can be disposed of safely.

|
Stand| The stands consist 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 electronic components. All components comply with RoHS and REACH directives and can be disposed of safely.|

TECHNICAL SPECIFICATIONS

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 hours

Mains adapter

Maximum radiance output of the TL 35

Radiance output

| Risk group classified in accordance with IEC 60601-2-83| ****

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 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 CISPR 11, IEC61000-3-2, IEC61000-3-3, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5,

IEC 61000-4-6, IEC 61000-4-11, 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.

WARRANTY

Further information on the warranty and warranty conditions can be found in the warranty leaflet supplied.

Contact Information

Globalcare Medical Technology Co., Ltd.

• 7th Building, 39 Middle Industrial Main Road, European Industrial Zone, Xiaolan Town, 528415 Zhongshan City, Guangdong Province, P.R. China.
• Phone: +86 760 22589901

BEURER GmbH

• Söflinger Str. 218 89077 Ulm (Germany)
• Tel.: +49 (0) 731 / 39 89-144
• Fax: +49 (0) 731 / 39 89-255
• www.beurer.com
• Mail: kd@beurer.de.

Donawa Lifescience

• Piazza Albania, 10, 00153 Rome, Italy.
• https://www.donawa.com/wli/main/contatti.index.

Camara and Partners Sàrl

• Route de St Cergue 14, 1260 Nyon, Switzerland
• Tel: +41 22 362 48 13

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