Fysic FW450 Daylight Lamp with Mood Lighting Instruction Manual

Fysic FW450 Daylight Lamp with Mood Lighting Instruction Manual

What In The Box

Assembly

Distance (Low Intensity)
Approx. 30 min| 18 cm| 12 cm
Approx. 1 hr| 30 cm| 20 cm
Approx. 2 hr| 45 cm| 35 cm

DEVICE AND CONTROLS

1. On/off button / white light intensity button
2. RGB color button
3. Stand
4. Light source of the FW450
5. AC Power cord

SIGNS & SYMBOLS

The following symbols appear in this manual, on the FW450 Daylight lamp with mood lighting or on its accessories:

| Read operating instructions before use
---|---
| On/of
| Class II Equipment
| Specifies serial number of the FW450 Daylight lamp with mood lighting
| Authorized Representative in the European Community
| Caution: Consult accompanying documents
RGB| Mood light button
IP21| Ingress Protection Rating
| Date of Manufacture
| Manufacturer
| Medical Device
| Importer

ABOUT THE DAYLIGHT LAMP WITH MOOD LIGHTING

Instructions for use
Congratulations on the purchase of your new FW450 Daylight lamp with mood lighting. The product will offer many years of reliable usage if handled correctly. Please keep your receipt, these instructions and the original packaging safe in case of future requirement. Please read the instructions carefully to gain the most benefit from your new FW450 Daylight lamp with mood lighting, although the usage guidelines in this document do not replace the advice of your qualified medical advisor.

Intended use
Medical intended use of this appliance is to treat SAD (seasonal affective disorder) or winter depression. The FW450 Daylight lamp with mood lighting is intended to boost people energy level, to adjust circadian rhythms and make people feel more awake.
The FW450 Daylight lamp with mood lighting is safe and medically proven to relief from the winter blues.

How does the FW450 Daylight lamp with mood lighting work?
In autumn and winter, the seasons with the least sunlight because of shorter days, the lack of sunlight and a problem with certain brain chemicals stops the hypothalamus working properly. The lack of light is thought to affect the production of the hormone melatonin (that makes you sleepy).
The FW450 Daylight lamp with mood lighting uses bright lights to simulate the sunlight during the darker autumn and winter, whilst eliminating the dangerous UV rays contained in sunlight. The additional light helps your brain to reduce to production of hormone melatonin, adjust the levels of melatonin that can help the symptoms ofSAD or winter depression.

Seasonal Affective Disorder
Seasonal Affective Disorder (SAD) as known as winter depression, winter blues. It may cause people:

• Feel low, listless and fatigued
• Have trouble concentrating
• Lacking in energy
• Need for more sleep
• Less active than normal

Symptoms occur during the same season each year. Most people with SAD start to have symptom in winter and feel better in summer.

Contraindication
The following conditions may be contraindication for use of this appliance:

• Suffer(ed) from severe depression
• Recent eye surgery or a diagnosed eye condition which your doctor advised you to avoid bright light
• On specific medication (i.e. certain antidepressants, psychotropic drugs or malaria tablets);
• Have high blood pressure with vitreous hemorrhage have no benefit;
• Skin sensitive to light, such as systemic lupus erythematosus

Always consult your doctor before your start using this appliance if you have any of the above conditions.

Possible side effects
The following side effects you may experience:

• headaches
• sleeping problems
• Eyestrain
• Nausea

Measures to avoid, minimize or alleviate these side effects:

• Increase the treatment distance
• Avoid using the appliance during the late evening or before sleep
• Stop using the appliance for a few days to make the side effects disappear and then try again.

SAFETY AND PERFORMANCE STANDARDS

The FW450 Daylight lamp with mood lighting has been designed and manufactured to conform to the highest standards of safety and performance including electromagnetic compatibility (EMC). The FW450 Daylight lamp with mood lighting conforms to the applicable requirements of the following:

This appliance meets the requirement of Medical Device Directive 93/42/EEC and parts of Medical Device Regulation (EU) 2017/745 for medical appliances

The appliance is complied with the following emission and immunity standard, and test level:

Immunity Test standard| IEC 60601-1-2 Test Level| Compliance Level
---|---|---
Electrostatic discharge
(ESD)
IEC 61000-4-2| ±8kV contact
± 2kV, ± 4kV, ±8kV, ± 15kV air| ± 8 kV contact
+ 2kV, ± 4kV, ± 8kV, ± 15kV air
Electrical fast
transient/burst
IEC 61000-4-4| ± 2kV, for power supply lines
± 1kV Signal input/ output
100 kHz repetition frequency| ± 2kV, for power supply lines
Not applicable
100 kHz repetition frequency
Surge IEC 61000-4-5| ± 0.5kV, ± 1kV differential lines
± 0.5kV, ± lkV, ± 2kV common mode| ± 0.5kV, ± lkV differential lines
Not Applicable
Voltage dips, interruptions and variations on power supply input lines
IEC 61000-4-11| 0 % UT; 0.5 cycle. At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°. 0 % UT; 1 cycle and 70 % UT; 25/30 cycles; Single phase: at 0°. 0 % UT; 250/300 cycle| 0 % UT; 0.5 cycle. At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°. 0 % UT; 1 cycle and 70 % UT; 25/30 cycles; Single phase: at 0°. 0 % UT; 250/300 cycle
Power frequency (50/60 30 A/m I lz) magnetic field SOHz/6OHz
IEC 61000-4-8| 30 A/m 50F1z/60Hz| 30 A/m 50F1z/60Hz
Conducted RF IEC 61000-4-6| 3V 0,15 MHz – 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz| 3V 0,15 MHz – 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz
Radiated RF IEC 61000-4-3| 10 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz| 10 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz

Note: UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic Immunity

Radiated RF
IEC61000-4-3
(Test
specification for
ENCLOSURE
PORT IMMUNITY
to
RE wireless
communications
equipment)| Test
Frequency| Band
(MHz)| Service| Modulation| Modulation
Oh| Distance
(m)| IMMUNITYTESTLEVELOr/m)
385| 380 – 390| TETRA 400| Pulse
modulation
18 Hz| 1.8| 0.3| 27
450| 430 – 470| GMRS 460,
FRS 460| FM
± 5 kHz
deviation
1 kHz sine| 2| 0.3| 28
710| 704 – 787| d 13 an         13.
LTE B17| Pulse
modulation
217 Hz| 0.2| 0.3| 9
745
780
810| 800 – 960| GSM
800/900,
TETRA 800.
iDEN 820.
CDMA 850,
LTE Band 5| Pulse modulation 18 Hz| 2| 0.3| 28
870
930
1720| 1 700 -1 990| GSM 1800:
CDMA 1900:
GSM 1900:
DECT:
LTE Band 1.
3.4.25;
UMTS| Pulse
modulation
217 Hz| 2| 0.3| 28
1845
1970
2450| 2 400 -2 570| Bluetooth.WEAN,802.11b/g/n.
RFID 2450.
LTE Band 7| Pulse modulation 217 Hz| 2| 0.3| 28
5240| 100 – 5 00 5  8| WLAN
802.11
a/n| Pulse
modulation
217 Hz| 0.2| 0.3| 9
5500
5785

NOTES

Please read these instructions for use carefully and keep them for later use, be sure to make them accessible to other users and observe the information they contain.

Safety notes

• Do not use this appliance in wet surroundings (e.g. in the bathroom or near a shower). Do not immerse appliance in water or any other liquid.
• This appliance is suitable in home healthcare environment.
• Before use, ensure that all packaging materials are removed and that there is no visible damage to the appliance. When in doubt, do not use the appliance and contact your dealer or the customer service address provided.
• This appliance is only intended for use on the human body.
• Close supervision in necessary when this appliance is used by, or near children  or invalids.
• Children should be supervised to ensure that they do not play with the appliance. Don’t need any special training for this appliance.
• Keep the appliance away from children and pets.
• Keep the cord away from hot objects and open flames.
• Connect the appliance only to the mains voltage listed on the type plate.
• Do not use the appliance in a room where there is no other light source, as this may cause eyestrain. Use the light of this appliance as an addition to the normal light (sunlight, electric light) in your home.
• Do not look straight into the light too long, as this may be uncomfortable to your eyes.
• Do not use the appliance where its light may hinder you or other people during the performance of essential tasks such as driving or operating heavy equipment.
• Always remove the mains plug and let the appliance cool off before you touch it.
• Do not touch the appliance with wet hands while it is plugged in; do not allow any water to be sprayed onto it. The appliance must be operated only when it is completely dry.
• Protect the appliance from strong impacts.
• Avoid pulling the cord when removing the plug from the socket. Instead, hold the plug.
• If the cord or the appliance is damaged, contact customer service or the dealer, since special tools are needed to make repairs. Never try to repair the appliance yourself. Opening the product will invalidate the guarantee.
• Disconnection from the power supply network is only guaranteed when the mains part is unplugged.
• This appliance is not suitable for use in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide.
• This appliance requires no calibration, preventive inspection and maintenance.
• This appliance is not repairable and contains no user serviceable parts.
• The operator shall not touch the appliance and the patient simultaneously.
• The appliance is protected against unauthorized use. Do not modify this appliance without authorization of the manufacturer.
• It is not permitted to make modifications to the device.

General notes

• This appliance is not intended for commercial or clinical use, but only for individual, private household use.
• If you are taking medication such as pain relievers, antihypertensives or antidepressants, consult your doctor before using this appliance.
• People with retinal diseases as well as diabetics need to be examined by an ophthalmologist before beginning to use this appliance.
• Please do not use if you have an eye disease such as cataracts, glaucoma, diseases of the optic nerve in general and inflammation of the vitreous humour.
• If you have health concerns of any kind, contact your general practitioner!

EMC Information

• Warning: Use of this appliance adjacent to or stacked with other device should be avoided because it could result in improper operation. If such use is necessary, this appliance and the other device should be observed to verify that they are operating normally. If the appliance does not light on or flickering, it means that the appliance is not operating normally.
• Warning: Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
• Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm to any part of this appliance, including power cable. Otherwise, degradation of the performance of this equipment could result.
• If the appliance does not light on or flickering due to the electromagnetic disturbances, do not use it and try to place the appliance in other location.
• For maintaining the basic safety and essential performance with regard to electromagnetic disturbances for the expected service life, please precaution to take if the use location is near (e.g. less than 1,5 km from) from AM, FM or TV broadcast antennas

Maintenance and Repairs

• Avoid exposing the light source of the device to direct sunlight, spotlight or any other heat source.
• Do not use alcohol or ammonia base liquid to clean the light course of the device. The cleaning information provided in the section “Cleaning and Storage”.
• Please do not attempt to repair the appliance yourself. This could result in serious injuries. Failure to observe this regulation shall void the warranty.
• If the appliance is damaged in any way or it is not working, it should not be operated. Please try to fix the problem according to FAQ table. If the problem still not resolved, please contact customer service or the dealer, since special tools are needed to make repairs. Never try to repair the appliance yourself. Manufacturer will provide proper guidelines and materials to assist to service personnel in parts repair.

4. OPERATION (see also the pictures in the beginning of this manual)

Before use, please check the appliance for damage or faults. If you notice any damage or faults on the appliance, do not use it and contact customer services or your supplier.

Fold the stand out. Place the appliance on a solid surface such as table. Place the appliance at an angle to your body to avoid looking at the appliance directly.

Place the appliance approximately 12-45 cm from your eyes. You can read, eat, work at computer, watch TV or exercise while you use the appliance.

Plug in the appliance and switch on the light with higher intensity by pressing the ON/OFF button. To choose a lower intensity, press the ON/OFF button again.

Recommended times to use Daylight lamp:

Duration of light therapy| Distance (High Intensity)| Distance (Low Intensity)
---|---|---
Approx. 30 min| 18 cm| 12 cm
Approx. 1 hr| 30 cm| 20 cm
Approx. 2 hr| 45 cm| 35 cm

In effect, the closer you are to the source of light, the less time you need to use it.

Note

• Push the plug completely into the mains socket.
• Ensure that there is a socket near the place where the appliance will stand.
• Lay the mains cable in such a way that no one can trip over it.
• Do not place the appliance on the position that is difficult to disconnect it.
• Do not look directly into the light continuously! Some eye pain or mild headaches may be experienced during initial sessions but these should pass. If in doubt just lower your treatment times until you feel comfortable again.
• The appliance automatically turns OFF after 4 hours of continuous use  forprotect the safety

During the darkest period of the year, repeat use the appliance every day at the right time to achieve the result. It is usually sufficient to use 30 minutes a day, it depends on light intensity and distance. It is safe to use it longer, if you want it. Do not use the appliance late within 3 hours of going to bed; it could disrupt your sleep.

Press and hold the ON/OFF button for 2 seconds to turn off the appliance at any time.

Mood light: In addition to the normal daylight, the Daylight lamp also features a mood light with change of colour.

1. To switch to coloured mood light, press the RGB button.
2. To choose a different light colour, press the RGB button again.
3. To change back to white therapy light, press the ON/OFF button.
4. Press and hold the RGB button for 2 seconds to turn off the appliance at any time.

Note: The mood light must not be considered for medical purpose.

CLEANING AND STORAGE

• Before you clean the appliance, always switch it off, unplug it and let it cool off.
• Do not touch the appliance with wet hands.
• Clean using a damp cloth, to which you can apply a little detergent if necessary.
• Do not let water run into the appliance or spill water onto the appliance.
• It’s advised to clean the device once per month.

When this appliance is not being used, it should be stored in a dry location out of reach of children. Do not keep the appliance connected to a power source. Follow the storage instructions provided in the “Technical Specification” Chapter.

DISPOSAL

Please note that this appliance is marked with the WEEE symbol on the left. This means that this appliance must not be disposed of together with ordinary household waste, as electrical and electronic waste must be disposed of sepa rately

If you have any questions, please contact your local authorities responsible for waste disposal.

FAQ

button
No power| Connect the main plug correctly
The main cable is defective.Contact customer services or your retailer
LEDs have reached the end of its service life| If you need to have the appliance repaired, contact customer service or an authorized dealer.
LEDs faulty / electronic problem

TECHNICAL SPECIFICATION

pressure: 700-1060hPa
Storage/transport environment| -100C to 600C, 30-90% relative humidity Atmospheric pressure: 700-1060hPa
Product classification|

1. Class II equipment
2. No applied part
3. Protection against ingress of water: IP21
4. Not category AP / APG equipment
5. Mode of operation: Continuous operation

Maximum length of power cord| 135 cm
Location of emissions aperture| Light source of the FW450
Treatment area| 600 cm2
Risk group of light source equipment| Group 1 in blue light classified by IEC 60601-2-57:2011
Product service life| 2 years

Maximum output of optical radiation for the FW450 Daylight lamp with mood lighting

Radiance Output| Risk group classified by IEC 60601-2-57:2011| Max. value
---|---|---
EUVA: Eye UV-A| Exempt Group| 1.5×10-4 W·m-2
ES: Actinic UV skin & eye| Exempt Group| 1.5×10-4 W·m-2
EIR: Infrared radiation hazard exposure limits for the eye| Exempt Group| 6×10-4 W·m-2
EH: Thermal hazard for the skin| Exempt Group| 3.5×101 W·m-2
LB: Blue light| Risk Group 1| 10×102 W·m-2·sr-1
LR: Retinal thermal| Exempt Group| 2×102 W·m-2·sr-1

CONTACT INFORMATION

The FW450 Daylight lamp with mood lighting is manufactured by:

Zero-Plus International Limited
Room 1004, 10/F., Join-In Hang Sing Centre,
71-75 Container Port Road, Kwai Chung,
New Territories, Hong Kong
Email: sales@zeroplus.hk

The FW450 Daylight lamp with mood lighting is imported by:

Commaxx B.V.
Wiebachstraat 37
6466 NG Kerkrade
The Netherlands

European Authorised Representative:

Globalmind Consumer Electronics GmbH
Ernst-Mantius-Str.11,
21029 Hamburg, Germany

Important

If this appliance is damaged in any way or it is not working and you cannot find the answer to your question in FAQ.
Please contact customer service or the retailer for assistance.

DECLARATION OF CONFORMITY

Hereby, Commaxx declares that the type Fysic FW450 is in compliance with directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address: http://DOC.hesdo.com/FW450-DOC.pdf

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