12
13
SAFETY AND PERFORMANCE STANDARDS
This therapy lamp has been designed and manufactured to conform to the highest standards of safety
and performance including electromagnetic compatibility (EMC). The therapy lamp conforms to the
applicable requirements of the following:
- This appliance meets the requirement of Medical Device Directive 93/42/EEC for medical appliances.
- The appliance is complied with the following emission and immunity standard, and test level:
Emissions Test Standard
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations / flicker emissions IEC 61000-3-3
Comply
GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY
Radiated RF
IEC61000-4-3
(Test
specification
for
ENCLOSURE
PORT
IMMUNITY to
RF wireless
communica-
tions
equipment)
Test
Frequency
(MHz)
Band (MHz)
Service
Modulation
Modulation
(W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/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
LTE Band 13, 17
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
1700 - 1990
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
2400 - 2570
Bluetooth, WLAN,
802.11 b/g/n, RFID
2450, LTE Band 7
Pulse modulation
217 Hz
2
0.3
28
5240
5100 - 5800
WLAN 802.11 a/n
Pulse modulation
217 Hz
0,2
0.3
9
5240
5785
INTENDED USE
HOW DOES THE THERAPY LAMP WORK?
SEASONAL AFFECTIVE DISORDER
CONTRAINDICATION
Medical intended use of this appliance is to treat the symptoms of SAD (seasonal affective disorder)
or winter depression. This therapy lamp is intended to boost people’s energy levels, to adjust circa-
dian rhythms and make people feel more awake. This therapy lamp is safe and medically proven to
provide relief from the symptoms of SAD.
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).
This therapy lamp 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 of SAD or winter depression.
Seasonal Affective Disorder (SAD) as known as winter depression or winter blues. It may cause people:
- Feel low, listless and fatigued
- Need for more sleep
- Have trouble concentrating
- Less active than normal
- Lack energy
Symptoms occur during the same season each year. Most people with SAD start to have symptoms
during winter and feel better in summer.
The following conditions may be contraindication for use of this appliance:
- suffer(ed) from severe depression
- recent eye surgery or a diagnosed eye condition whereby doctor has 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;
- 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:
- Headaches
- Eyestrain
- Sleeping problems
- 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.
