Gima GIMAled81, Instruction Manual

Page: 106 / 114

OPERATION AND
MAINTENANCE MANUAL
EN
MU_027 Rev.1 29/04/2020 Page 25 of 33
General data
Colour RAL 9003
Directive 93/42/CEE e 2007/47/CE
Standards IEC 60601-2-41
Classification of Medical Device Class I
Essential
performance
Distribution of minimum and adequate lighting (luminous flux emitted by the EM equipment shall
not vary by more than 20% during use; the colour temperature and colour rendering index shall be
stable and within the range 3000K-6700K and 85-100, respectively; E
c
value shall be ≥ 40,000 lux and
≤ 160,000 lux).
Limitation of energy in the operating field (UV-irradiance for wavelengths below 400 nm shall not
exceed 10 W/m
2
; and the total irradiance E
e
in the lighted area shall not exceed 1000 W/m
2
at a
distance of 1000 mm; E
c
value shall be ≥ 40,000 lux and ≤ 160,000 lux; E
e
/E
c
≤ 6 mV/m 2 lx).
IP degree of protection IP20
Operating conditions Continuous operation
Handpiece steam sterilization
121°C and 1.3bar for 25 to 30 minutes.
134°C and 2.3bar for 4 minutes.
Mains power voltage insulation means
Outside the product (main switch) for ceiling versions.
Main switch for mobile versions.
Dimensions
Diameter of lamp body [cm] 52
Light emission surface [cm
2
] 567
Weight of Product in ceiling, double ceiling,
mobile [kg]
45, 75, 75
Markings
In conformity with Directive 93/42/EEC (and 2007/47/EC)
All technical light measurements are to be deemed with a tolerance of ±6% for metrological and manufacturing
reasons
D = with big diameter selected; d = with small diameter selected