Installation Instructions
www.amico.com
Gamma 50 LED Light System
Corporation
Contents
Symbols 3
Safety Instructions 4
Installation
Installation of Gamma 50 Rail Mount 5
Securing the holding device 5
Installing the spring arm 6
Installation of Gamma 50 Ceiling Mount 7
Installing the ceiling xture 8-9
Installing the spring arm 10
Operation 11
Disinfection And Cleaning 12
Maintenance 12
Disassembly And Disposal 13
Troubleshooting 13
Technical Data 14
EMC-Inspection Report 15-17
2 Amico Lighting Solutions
Symbols
i
i
i
2 symbols
The warning symbol is used for all instructions that are important for safety. If warnings are
ignored, users may be injured or the light or surroundings may be damaged. The warning
symbol is used with the following signal words as follows:
Maximale relative Luftfeuchtigkeit
Stromführender Leiter
Europäisches Konformitätskennzeichen
Minimale und maximale Lager- und Transporttemperatur
Entsorgung
hinweis
Kann zu Sachschäden führen.
Neutralleiter Rückleiter für den Strom
Begleitpapiere beachten
Schutzleiter
info
Nicht sicherheitsrelevante, aber nützliche oder wichtige Informationen.
warnung
Kann zum Tod oder schwerer Körperverletzung führen.
Das Warnsymbol kennzeichnet alle für die Sicherheit wichtigen Anweisungen. Nichtbeach-
tung kann zu Verletzungen, Schäden an der Leuchte oder der Einrichtung führen! In Verbin-
dung mit den folgenden Signalwörtern steht das Warnsymbol für:
VorsiCht
Kann zu leichten Körperverletzungen führen.
2 symbolbeDeutung
Hersteller
Wechselstrom
Netzschalter ein-/ausschalten
Leuchtenkopf ein-/ausschalten
The warning symbol is used for all instructions that are important for safety. If warnings are ignored, users may be
injured or the light or surroundings may be damaged. The warning symbol is used with the following signal words as
follows:
i
warning
May cause death or serious injury.
Caution
May cause minor injury.
i
note
i
May cause property damage.
info
Information that is useful or important but not relevant to safety.
Observe accompanying documents
Protective earth
Alternating current
Mains switch on/off
Switch light head on/off
Live conductor
Neutral conductor return line for current
European conformity mark
Maximum relative humidity
Minimum and maximum storage and transport temperature
Disposal
Manufacturer
www.amico.com 3
Safety Instructions
Intended Use
The Gamma 50 LED examination light is designed to provide illumination of the body of a patient for local diagnosis or
treatment. The light is not designed for use during surgery. It is designed for continuous operation. It must be possible
to stop the treatment or diagnosis without danger to the patient if the light fails during use.
User Proles
• Medical sta
• All persons with medical training who work in the eld for which they were trained.
• Cleaning sta
• All persons familiar with national and workplace hygiene requirements.
• Electricians
• All persons with training in electronics and electrical technology who are familiar with the relevant standards
and regulations.
Safety Instructions
• The instructions are part of the product and must be kept so they are accessible for all subsequent users.
• All applicable occupational health and safety regulations and the requirements specied by the national
regulators for hygiene and disinfection must be observed to reduce the risk of disease transmission as much
as possible.
• The installation must only be carried out by a qualied electrician.
• Repairs to the cable or lens must only be carried out by a qualied electrician, all other repairs must be carried
out by the manufacturer’s service department.
• The light must not be modied or manipulated. Use in any other manner than with the original parts may
result in dierent specications and life-threatening dangers.
• Danger of death from electric shock. Do not plug in a damaged cable. The mains voltage and frequency must
match the data on the name plate.
• The light must not be used in an explosive environment. The power supply to the light is a potential ignition
source.
• Keep all ammable equipment and objects away from the light head during use.
• Do not modify any conductive parts.
• Do not use a damaged light. Defective cables can also be a potential hazard. Do not position cables near heat
sources or sharp edges.
• Danger of injury! Replace damaged glass before using the light again.
• Eye damage! Never look directly at the light cone.
• The light must be used in dry rooms only.
• The light must not be left on unattended.
• Do not place any materials (such as cloths, rags etc.) on top of the light head.
• Never apply additional loads to the light head and the spring arm.
Specic Safety Instructions
• The light must only be mounted such that the type of xture can be guaranteed to be secure.
• The ceiling must be solid concrete to guarantee secure xture for the light. If this is not the case, safety must
be checked by structural engineers and the light secured with a suitable xture material.
4 Amico Lighting Solutions
Installing Gamma 50 LED Rail Mount
Included:
Gamma 50 LED articulating arm Country-specic power cable
Gamma 50 LED gooseneck arm
Securing the Holding Device
www.amico.com 5
Installing Gamma 50 LED Rail Mount
Installing the Spring Arm
6 Amico Lighting Solutions
Installing Gamma 50 LED Ceiling Mount
Included:
Gamma 50 LED ceiling mount 6x wall anchors with
nuts and washers
1x cover
1x ceiling tube1x Plastic ring1x Cable 1x ceiling xture
www.amico.com 7
Installing Gamma 50 LED Ceiling Mount
Installing the Ceiling Fixture
8 Amico Lighting Solutions
Installing Gamma 50 LED Ceiling Mount
www.amico.com 9
Installing Gamma 50 LED Ceiling Mount
Installing the Spring Arm
10 Amico Lighting Solutions
Operation
Color
Blue
(cold white)
White
(neutral white)
Red
(warm white)
Color
Recommendation
Temperature
4,700 K Ideal for identifying individual vessels for wound
follow-up treatment and small procedures
4,100 K Ideal for general examinations
3,500 K Ideal for various types of skin examinations
www.amico.com 11
Disinfection And Cleaning
Maintenance
12 Amico Lighting Solutions
Disassembly And Disposal
Troubleshooting
Light does not operate? User profiles
1 Switch on light head (keypad) All
2 Switch on the transformer
3 Connect the mains cable to the transformer casing correct
4 Plug the mains cable to the socket correctly
5 Check mains voltage Electricians
6 Contact manufacturer’s service By manufacturer’s
service only
www.amico.com 13
Technical Data
Electrical:
Nominal voltage 100 – 240 V ~
Frequency range 50/60 Hz
Power consumption 47 – 56 VA
Illumination:
Central illuminance (EC) at 0.5 m 50,000 Lux (dimmable)
Light eld diameter d10 at 0.5 m ø = 17 cm
Color temperature adjustable
Cold white 4,700 K
Neutral white 4,100 K
Warm white 3,500 K
Color rendering index Ra ≥ 95
Light source service life 30,000 h
Total illuminance 50‘000 Lux
Environmental Conditions For Transport, Storage And Operation:
Ambient temperature (storage and transport) –20 °C to +70 °C
Ambient temperature (operation) 10 °C to +40 °C
Relative humidity (non -condensing) 10% to 95%
Dimensions:
Luminous body ø 100 x 105 mm
Weight:
Ceiling mount approx. 7.5 kg
Articulating arm rail approx. 1.5 kg
Gooseneck rail approx. 1.5 kg
Operating mode:
Operating mode continuous operation
Classication:
Gamma 50 LED Class I
Protection class as per IEC 60529 IP 20
Classication under 93/42 EEC – Annex IX Class I
(medical device class)
Electrical safety and EMC comply with: EN/IEC 60601-1
EN/IEC 60601-2-41
EN/IEC 60601-1-2
14 Amico Lighting Solutions
EMC-Inspection Report
Table 1: Emission
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The Gamma 50 LED is intended for use in the electromagnetic environment specied below. The customer or the user of the
Gamma 50 LED should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage uctuations / icker emissions
IEC 61000-3-3
Group 1 The Gamma 50 LED 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.
Class B The Gamma 50 LED is suitable for use in all establishments,
including domestic establishments and those directly
Class C
Complies
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Table 2: Immunity (All Devices)
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Gamma 50 LED is intended for use in the electromagnetic environment specied below. The customer or the user of Gamma
50 LED should assure that it is used in such an environment.
Immunity test standard IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient /
burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±6 kV contact
±8 kV contact
±2 kV for power
supply lines
±1 kV line to line
±2 kV line to earth
±8 kV air
±15 kV air
±2 kV for power
supply lines
±1 kV line to line
±2 kV line to earth
Floors should be wood, concrete or ceramic tile.
If oors are covered with synthetic material, the
relative humidity should be at least 30%
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
www.amico.com 15
EMC-Inspection Report
Table 3: Immunity (All Devices)
Immunity test
standard
Voltage dips, short
interruptions and voltage
variations on power
supply lines
IEC 61000-4-11
IEC 60601 test
level
<5% UT (0,5 cycle)
40% UT (5 cycles)
70% UT (25 cycles)
<5% UT for 5s
Compliance level
<5% UT (0,5 cycle)
40% UT (5 cycles)
70% UT (25 cycles)
<5% UT for 5s
Electromagnetic environment -
guidance
Mains power quality should be that of a typical
commercial or hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
Power frequency
(50/60 Hz)
Magnetic eld
IEC 61000-4-8
3 A/m 100 A/m Power frequency magnetic elds should be at
levels characteristic of a typical location in a typical
commercial or hospital environment.
Table 4: Immunity (Not Life-Supporting Devices)
Guidance and manufacturer’s declaration – electromagnetic immunity
The Gamma 50 LED is intended for use in the electromagnetic environment specied below. The customer or the user of the
Gamma 50 LED should assure that it is used in such an environment.
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be used no closer to any part of the Gamma 50 LED, including cables,
than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Immunity test standard IEC 60601 test level Compliance level Recommended separation distance C
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 800 MHz
3 V/m
800 MHz to 2,5 GHz
V1 = 10 Vrms
(estimated value)
150 kHz to 80 MHz
E1 = 10 V/m
80 MHz to 800 MHz
E2 = 10 V/m
800 MHz to 2,7 GHz
d = 0.35 √P 150 kHz to 80 MHz
d = 0.35 √P 80 MHz to 800 MHz
d = 0.7 √P 800 MHz to 2,7 GHz
16 Amico Lighting Solutions
EMC-Inspection Report
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is
the recommended separation distance in metres (m).
Field strengths from xed RF transmitters, as determined by an electromagnetic site survey, a
Should be less than the compliance level in each frequency range. b
Interference may occur in the vicinity of equipment marked with the following symbol:
Note 1:
At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2:
a
b
c
These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and
reection from structures, objects and people.
Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey
should be considered. If the measured eld strength in the location in which the Gamma 50 LED is used exceeds
the applicable RF compliance level above, the Gamma 50 LED or the device, which contains it should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device containing the Gamma 50 LED
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 10 V/m.
Possible shorter distances outside ISM bands are not considered to have a better applicability of this table.
Table 6: Recommended Separation Distances (Not Life-Supporting Devices)
Recommended separation distances between portable and mobile RF communications equipment
and the Gamma 50 LED
The Gamma 50 LED is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the Gamma 50 LED can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the Gamma 50 LED as recommended below,
according to the maximum output power of the communication equipment.
Rated maximum output
power of transmitter W
0,01 0.04 cm 0.04 cm 0.07 cm
150 kHz to 80 MHz
Separation distance according to frequency of transmitter M
80 MHz to 800 MHz
d = 0.35 √P
d = 0.35 √P
800 MHz to 2500 MHz
d = 0.7 √P
0,1 0.12 cm 0.12 cm 0.23 cm
1 0.35 m 0.35 m 0.7 m
10 1.11 m 1.11 m 2.3 cm
100 3.5 m 3.5 m 35 cm
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and
reection from structures, objects and people.
Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance to decrease the likelihood
that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient
areas.
www.amico.com 17
www.amico.com
Amico Lighting Solutions | www.amico.com
85 Fulton Way, Richmond Hill
Ontario, L4B 2N4, Canada
Toll Free Tel: 1.877.264.2697
Toll Free Fax: 1.866.440.4986
Tel: 905.763.7778
Fax: 905.763.8587
Email: info@amico.com
LT INSTALL INSTR. GAMMA SERIES MAR 2012
Loading...