beurer TL 85 Daylight Therapy Lamp Instruction Manual

TL 85 Daylight Therapy Lamp
Instruction Manual

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Unfold page 3 before reading the instructions for use.

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.

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:

• 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 on the human body. Sunlight indirectly controls the  production of melatonin, which is only passed to the blood 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.

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:

| WARNING
Warning notice indicating a risk of injury or damage to health| | CE labeling
This product satisfies the requirements of the applicable European and national directives.
---|---|---|---
| IMPORTANT
Safety note indicating possible damage to the device/accessory| | Permissible storage temperature and humidity
| Product information
Note on important information| | Permissible operating temperature and humidity
| Observe the instructions
Read the instructions before starting work and/or operating devices or machines| IP21| Protected against solid foreign objects 12.5 mm in diameter and larger, and against vertically falling drops of water
IP24| Protection against solid objects greater than 12,5mm and against splashes of water from all directions.
| Manufacturer| | Serial number
| Protection class II device
The device is double-insulated and is, therefore, in protection class 2| | Dispose of packaging in an environmentally friendly manner
| ON/OFF| | Marking to identify the packaging material. A = Material code, B = Material number: 1-7 = Plastics,
20-22 = Paper and cardboard
| Medical device| | For indoor use only
| Item number| | Authorized representative in the European Community
| Date of manufacture| | Importer symbol
| atmospheric pressure limitation| | Unique Device Identifier (UDI) for unique product identification
| Disposal in accordance with the Waste Electrical and Electronic Equipment EC Directive — WEEE| | Direct current
The device is suitable for use with direct current only
| Batch Code| | Type
| Separate the product and packaging elements and dispose of them in accordance with local regulations.|

INTENDED PURPOSE

Purpose
The Bright Light 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
Adult and child over 3 years old.
Intended users
The use of the device does not require specific knowledge or professional ability. The patient is the intended operator except in case the patient required special assistance.
Indication
The device simulates daylight to provide relief from seasonal or mood disorders.

WARNINGS AND SAFETY NOTES

WARNING

• 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. If you have any doubts, do not use the device and contact your retailer or the specified Customer Services 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.

• Do not use the daylight therapy lamp on animals!

• Do not use the device on the patient is taking a photosensitizing medication or herb.

• Do not use the device on:
  – children under age 3
  – people insensitive to heat
  – people with skin lesions due to illness
  – people that have a condition that might render or their eyes more vulnerable to phototoxicity
  – people that have a photosensitive skin condi

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

• 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.

• 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 heavy 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 such cases, contact Customer Services.

• In the event of damage to the mains connection cable for this device, the cable must be disposed of.
  If it is not a removable cable, 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 equipment unattended when it is switched on to avoid the risk of fire or burns.

• This equipment is not intended for use by children under three years. Children under three years should be supervised to ensure that they do not play with the equipment to avoid the risk of fire and burns.

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

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

• 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 the cable out of reach of young children.

• The device is intended for use by the patient themselves. The device and accessories must be used in accordance with these instructions for use.

General notes
WARNING

• This device must not be used by people with severe depression or with reduced physical, sensory or mental skills or a lack of experience or knowledge.
• Diabetics and people who suffer from retinal diseases must be examined by an optician 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.
• Please do not use it in case of recent eye surgery or a diagnosed eye condition whereby doctor has advised you to avoid bright light.
• It must not be used on people with disabilities, children under 3 years of age, or people with reduced sensitivity to heat (people with skin alterations due to illness).
• Severe cases of SAD should, in any case, be closely supervised by a clinician.
• 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.
• 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, keep it for at least two hours at room temperature before using it.
• The power adapter is part of the ME equipment.
• Power-on check item: please check whether light flashes, dark areas/shadows, and other abnormalities occur after power-on. If there is any abnormality, please contact the after-sales hotline.
• The patient cannot undergo an MRI scan while using this device.
• Please report any serious incident that has occurred in relation to the device injury or adverse event to the local competent authority and to the Manufacturer or to the  European Authorised Representative (EC REP) Vigilance contact point: https://ec.europa.eu/growth/sectors/medical-devices/contacts/
• PRC is the abbreviation of the People’s Republic of China.

Instruction 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 with this instruction will void the warranty.

• For repairs, please contact Customer Services or an authorized retailer.

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 set of instructions for use
• 1 mains adapter

DEVICE DESCRIPTION

The corresponding drawings are shown on page 3.

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.
Attach stand
Attach stand 3 to the device on the rear of the device housing.
Setting up the device
Place the device on a level surface. The position should be chosen to ensure a distance of between 25 cm and 45 cm between the user and the device. The lamp is most effective at this distance.

Mains connection

• 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.

Note
Ensure that there is the main socket close to the set-up area.
Arrange the mains cable in such a way that no one will trip over it.

USAGE

1. Insert the mains adapter into the connector.

2. Switching on the lamp
   Press and hold the On/Off button 5 for 2 seconds. When the device is next switched on, it will start with the saved brightness level and treatment time.

3. LED display/timer
   The TL 85 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 runs until it is switched off again or a treatment time is set (timer = 0  min). In order to use the timer, set the desired level from 1 to 4 by pressing briefly the On/Off button 5 . 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 off automatically after this treatment time and steadily becomes darker. To deactivate the timer function, briefly touch the On/Off button 5 until the LEDs go out.

4. Enjoying the light
   Position yourself as close as possible to the lamp, at a distance of between 25 cm and 45 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.
   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.

5. Things to consider
   We recommend a distance of between 25 and 45 cm from the face to the lamp during treatment.
   The treatment time depends on the distance: Lux| Distance| Treatment time
   ---|---|---
   10,000| approx. 25 cm| 0.5 hours
   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 treatment time.

6. 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.

7. Switching off the lamp
   Press and hold the On/Off button 5 for 2 seconds. The LEDs switch off. Unplug the mains adapter from the mains socket.
   IMPORTANT
   The lamp remains hot after use. Allow the lamp to cool down sufficiently 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 service address for your country (see the service address list). Accessories and replacement parts are also available from retailers.

WHAT IF THERE ARE PROBLEMS?

On/Off button 5 switched off
No power| Connect the mains adapter correctly.
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 authorized retailer.

DISPOSAL
For environmental reasons, do not dispose of the device in the 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 – WEEE (Waste Electrical and Electronic Equipment). 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.

TECHNICAL SPECIFICATIONS

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
Product classification| Protection class II, IP21
Accessories| Mains adapter, instructions for use, stand
Colour temperature of the LEDs| 6500K +/-400 Kelvin
Threshold of short wavelength| 460 – 670 nm
Maximum light output| 52.27 W / m2
The expected service life of the device| 10.000 hours

Maximum radiance output of the TL 85

Radiance output| Risk group classified in ac- accordance with IEC 62471| Maximum value
---|---|---
EWA: Eye UV-A| Exempt Group| 4.393e-5
ES: Actinic UV skin & eye| Exempt Group| 2.794e-6
EIR: Infrared radiation hazard exposure limits for the eye| Exempt Group| 4.631e-1
LIR: Retinal thermal
(mild visual irritation)| Exempt Group| 1.491e-1
LB: Blue light| Exempt Group| 7.057e0
LR: Retinal thermal| Exempt Group| 9.327e1

Subject to technical changes.
The serial number is located on the device or in the battery compartment.
Brightness: 10,000 lux (this point about the light intensity is merely for information purposes. With regard to the standard IEC 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 and the respective national regulations and 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 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.

Mains adapter

WARRANTY

Further information on the warranty and warranty conditions can be found in the warranty leaflet supplied.
Notification of incidents
For users/patients in the European Union and identical regulation systems (EU Medical Device Regulation (MDR) 2017/745), 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.

T able 1:

Guidance and manufacturer’s declaration – electromagnetic emissions

The Device is intended for use in the electromagnetic environment specified below. The customer or the user of the Device should assure that it is used in such an environment

Emissions t est

| Compliance|

Electromagnetic  environment – guidance

RF emissions CISPR 11| Group 1| The Device 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 B| The Device is suitable for use in all establishments In- cluding domestic 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| Class A
Voltage fluctuations/flicker emissions IEC 61000-3-3| Complies

T able 2:

Guidance and manufacturer’s declaration – electromagnetic immunity

The Device is intended for use in the electromagnetic environment specified below. The customer or the user of the
The device should assure that it is used in such an environment
Immunity test| IEC 60601
test level| Compliance
level| Electromagnetic environment –
guidance
Electrostatic di- scheme (ESD) IEC 61000-4-2| ±-2kV ±4kV ±6kV -±8kV ±15kV| ±8 kV contact
-±2kV -±4kV ±8kV -±15kV air| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %
Electrical fast transient/burst IEC 61000-4-4| t1 kV, -±2kV, 100 kHz repetition
frequency| Power supply lines ±2 kV| Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5| -±0.5kV, x1 kV (Line to line) -±0.5kV, t1 kV, -±2kV
(Line to Ground)| Line to line: ±0.5kV, ±1 kV Line to Ground: ±0.5kV, ±1kV, -±2kV| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interrupti- ons and voltage variations on power supply input lines| 0% U, for 0.5 cycle
0% U, for 1 cycle
70% U,| 0% U, for 0.5 cycle
0% U, for 1 cycle
70% U,| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interrupti- ons and voltage variations on power supply input lines
IEC 61000-4-11| for 25/30 cycles
0% UT
for 250/300 cycles| for 25/30 cycles
0% U,
for 250/300 cycles| Mains power quality should be that of a typical commercial or hospital environment. If the user of the model TL55 re-quire continued operation during power mains interruptions, it is recommended that the model 168 DAYLUX daylight therapy lamp be powered from an uninterruptible power supply or a battery.

Global care 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/ http://www.globalcare.com.hk/contact/

References

• Beurer – Beurer North America
• Contact – Globalcare

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