TL 45 - Lamp BEURER - Free user manual and instructions

USER MANUAL TL 45 BEURER

mation they contain. Dear customer, Thank you for choosing a product from our range. Our name stands for high-quality, thor- oughly tested products for applications in the areas of heat, weight, blood pressure, body temperature, pulse, gentle therapy, massage and air. With kind regards, Your Beurer team Why is the daylight therapy lamp called “Perfect Day”? The beurer TL 45 Perfect Day daylight therapy lamp has three adjustable colour tempera- tures and therefore enables various applications in order to regulate the day-night rhythm. The daylight therapy lamp can either be used to imitate the progression of a sunny day or it can be used in a targeted manner in order to support the phases of concentration, therapy and relaxation. The TL 45 Perfect Day daylight therapy lamp is based on the concept of “Human Centric Lighting”. In Human Centric Lighting (HCL for short), people and their perception of light are the focus. HCL deals with the psy- chological, physiological and psychobiological effect of light on people, for example light is the signal transmitter for the internal body clock. HCL uses alternating colour temperatures and different levels of light intensity to help people concentrate or relax in the best possible way. Different colour temperatures have a different effect on the human eye, for example. An increasing number of companies are creating the ideal workplace where employees are provided with the best possible light. This can increase motivation and productivity, and reduce errors and absences. The TL 45 Perfect Day daylight therapy lamp provides all of these benefits at your workplace or your home. It has three colour temperatures: “active”, “therapy” and “relax”.15 active therapy relax Simulated time of day Morning Afternoon Evening Activity Concentrated work Therapy at 10,000 lux Relaxation Kelvin 5,000 kelvins 6,500 kelvins 3,000 kelvins Lux 7,000 lux at a distance of approx. 20cm 10,000 lux at a distance of approx. 20cm 3,000 lux at a distance of approx. 20cm 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:

Increased need for sleep

Lack of energy and listlessness

Difficulty 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 effect 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 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 as compensation for the effects of a lack of light. Daylight therapy lamps simulate daylight over 10,000lux. This light can influ- ence 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.16

1. 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. In case of any doubt, do not use the device, and contact your retailer or the specified Customer Service address.

Daylight therapy lamp

These instructions for use

2. Signs and symbols

The following symbols are used on the device, in these instructions for use, on the pack- aging and on the type plate for the device: Read the instructions for use Note Note on important information WARNING Warning notice indicating a risk of injury or damage to health IMPOR- TANT Safety note indicating possible damage to the device/ accessories Manufacturer Protection class II YYYYXWW / XXXXXX YYYYXWW = year of manu- facture, year code and week of manufacture XXXXXX = serial number The CE labelling certifies that the product complies with the essential requirements of Directive 93/42/EEC on medical devices Disposal in accordance with the EC Directive on Waste Electrical and Electronic Equipment (WEEE). IP21 Protected against solid foreign objects 12.5 mm in diameter and larger, and against vertically falling drops of water Storage Permissible storage temperature and humidity Operating Permissible operating temperature and humidity For indoor use only

Dispose of packaging in an environmentally friendly manner Contents

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

4. Warnings and safety notes .................17

8. Cleaning and maintenance .................21

11. What if there are problems? ...............22

Direct current OFF/ON

The daylight therapy lamp is intended for radiation on human bodies only. Do not use the daylight therapy lamp on animals. The device is only intended for domestic/private use. The device is not intended for commercial use.

4. Warnings and safety notes

The daylight therapy lamp is intended for radiation on human bodies only.

Before use, ensure that there is no visible damage to the device or accessories 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.

Ensure that the daylight therapy lamp is positioned on a stable base.

The device must only be connected to the mains voltage that is specified on the type plate.

Never submerge the device in water and do not use it in the bathroom.

It must not be used on people with disabilities, children under 3 years of age or peo- ple with reduced sensitivity to heat (e.g. people with skin alterations due to illness), after taking pain relief medication, alcohol or drugs.

People who do not exercise due care and attention should not use the product.

Keep packaging material away from children (risk of suffocation!).

If the device is warm, do not cover it or pack and store it.

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

Do not touch the device with wet hands when it is plugged in and do not allow wa- ter to spray on the device. Operate the device only if it is completely dry.

Ensure that you insert and remove the mains cable and the plug with dry hands only and that you touch the ON/OFF sensor with dry hands only.

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

Protect the device from heavy impacts.

Do not pull the mains part 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 such cases, contact Customer Services.

If the mains cable of this device is damaged, the device must be disposed of.

Disconnection from the power supply network is only guaranteed if have you un- plugged the plug.

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

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 further use of the device.

Store the cable out of the reach of small children, so as to prevent them from be- coming entangled in the cable or from suffocating through strangulation.18

The device is intended for use by the patient themselves. The device and accesso- ries are to be used in accordance with these instructions for use.

Do not allow the product to fall from a height.

Requirements for positioning the product:

1. First, open the stand fully and set up the product in a horizontal position, to pre-

vent it from tipping over.

2. Do not shake the product when setting it up, to prevent it from falling.

3. Do not touch the stand when setting up the product, to prevent it from falling.

4. Do not pull on the cable of the mains part, to prevent the product from falling.

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 pres- sure or antidepressant medication.

Diabetics and people who suffer from retinal diseases must be examined by an opti- cian before using the daylight therapy lamp.

Please 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 or you are prone to migraine attacks.

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

Remove all packaging material before using the device.

Light sources are excluded from the warranty.

Switch-on test: after switching on the device, check if there are any bright flashes, dark areas / shadows or other anomalies. This is especially important to do once the lamp has reached the expected number of operating hours. If you notice any- thing unusual, please contact Customer Services.

The mains part is part of the medical equipment. Repairs IMPORTANT

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

For repairs, please contact Customer Services or an authorised retailer.19

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 an even surface. The position should be chosen to ensure a distance of between 20cm and 45 cm between the user and the device. The daylight therapy lamp is most effective at this distance. Note: If the device has been in storage or recently transported, keep it for at least two hours at room temperature before using it. Mains connection IMPORTANT To prevent possible damage to the device, the daylight therapy lamp must be used only with the mains part described here.

1. Insert the mains part into the mains part connector provided for this purpose on the rear of

the daylight therapy lamp and into a suitable mains socket. The mains part must be con

nected only to the mains voltage that is specified on the type plate.

2. After using the daylight therapy lamp, unplug the mains part from the mains socket first and

then disconnect it from the daylight therapy lamp. Note:

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.20

1 Plugging in the mains part Insert the mains part into the mains part connector on the rear of the daylight ther- apy lamp and into a suitable socket. 2 Switching on the daylight therapy lamp To switch on the daylight therapy lamp, touch the ON/OFF sensor . 3 Enjoying the light Select your desired setting by using the touch sensors on the daylight therapy lamp. We recommend the following two applications: Example of application in order to imitate a sunny day Programme Start of application relax 6 am active 10 am therapy 12 pm active 2 pm relax 8 pm Example of application for 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

Therapy setting application Position yourself as close as possible to the daylight therapy lamp (approx. 20 – 45cm). You can continue to go about your day-to-day activities during application, 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 like. However, the treatment is most effective if you carry out the light therapy for at least 7 successive days according to the prescribed times.

Regardless of the recommendation in point 3, you can use the therapy applica- tion at different times. The most effective time of day for treatment is between 6am and 8 pm.

Do not look directly into the light for the entire application period, as this may cause over-stimulation of the retina.

Start with a brief application period and gradually increase the time over the course of a week. Note: 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.21 5 What you need to bear in mind We recommend a distance of between 20 and 45 cm from the face to the daylight therapy lamp during application. The duration of the application depends on the distance: Lux Distance Application duration 10,000 Approx. 20 cm ½ hour 5,000 Approx. 30 cm 1 hour 2,500 Approx. 45 cm 2 hours In principle: The closer you are to the light source, the shorter the application time. 6 Enjoying the light over longer periods Repeat application on at least 7 consecutive days during darker periods of the year, or for longer depending on your individual needs. Application should take place during the mornings where possible. 7 Switching off the daylight therapy lamp To switch off the daylight therapy lamp, touch the ON/OFF sensor . The light will go out. Unplug the mains part from the mains socket. IMPORTANT The daylight therapy lamp remains hot after use. Allow the daylight therapy lamp to cool down sufficiently before putting it away and/or packing it away.

8. Cleaning and maintenance

Clean the device from time to time. WARNING

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 a 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 wa- ter to spray on the device. Operate the device only if it is completely dry.

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.22

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 the EC Directive on Waste Electrical and Electronic Equipment (WEEE). If you have any questions, please contact the local authorities responsible for waste disposal.

11. What if there are problems?

Problem Possible cause Solution Device does not light up Device is switched off Touch the ON/OFF sensor

No electricity Plug a mains part into a suitable socket. No electricity The mains part is faulty. Contact Cus- tomer 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.

12. Technical specifications

Model no. GCE 503 Type TL 45 Perfect Day Dimensions (W, H, D) 200 x 250 x 60 mm Weight Approx. 475 g Light LEDs Maximum light output Therapy 25 W/m² Active 25 W/m² Relax 14 W/m² Nominal output power Therapy 25 W ± 2 W Active 16 W ± 1 W Relax 6 W ± 1 W Light intensity Therapy 10,000 lux (distance of approx. 20cm ± 2 cm) 6,500 K Active 7,000 lux (distance of approx. 18cm ± 2 cm) 5,000 K Relax 3,000 lux (distance of approx. 18cm ± 2 cm) 3,000 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 pressure23 Threshold of short wavelength Therapy 445 nm Active 445 nm Relax 445 nm Operating height ≤ 2,000 m Product classification External power supply, IP21 Colour temperature of LEDs Therapy 6,500 K ± 300 K Active 5,000 K ± 300 K Relax 3,000 K ± 300 K Expected service life of the device 10,000 hours Maximum radiance output of the TL 45 Perfect Day Radiance output Risk group classified in ac- cordance with IEC60601-2-57:

UVA: Eye UV-A Exempt Group 4.784x10

EIR: Infrared radiation hazard exposure limits for the eyes Exempt Group 1.045x10

9.968x10 7.563x10 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 the purpose of in- formation. With regard to the standard IEC 60601-2-57, this light source is classified as an Exempt Group) Notes on electromagnetic compatibility The device complies with the EU Medical Devices Directive 93/42/EEC (therapy setting), the German Medical Devices Act (Medizinproduktgesetz) and the European standard EN 60601-1-2 (in accordance with CISPR-11, IEC61000-3-2, IEC61000-3-3, IEC 61000-4-2, IEC61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11) and is subject to particular precautions with regard to electromagnetic compatibility.

• The device is suitable for use in all environments listed in these instructions for use, in- cluding domestic environments.24

• 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 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 can impair the performance of the device.

Model no. MP 45-240150-AG MP 45-240150-AB Input 100–240 V ~ 50/60 Hz Output 24 V DC, 1.5 A, only in conjunction with GCE503 Protection The device is double-protected. Polarity of the DC voltage connection Classification IP21, protection class II Manufacturer Mitra Power Solutions Co., LTD Weight Approx. 170 g

14. Warranty/service

Mail: kd@beurer.de Donawa Lifescience Consulting Srl, Piazza Albania, 10, 00153 Rome, Italy 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