Dr. Mach LED 150FP - Instructions for Safe Use; Intended User; Information and Obligation of the User to Check the Product; Availability of the Instructions for Use

EN
User manual - English
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Mach LED 150
V6
2023-09-19
Congratulations on acquiring a new Mach LED 150 operating
light.
Please read these Instructions for use very carefully.
1. Instructions for safe use
1.1 Intended user
The Mach LED 150 is a Class I medical product and may only be
operated by trained medical staff.
1.2 Information and obligation of the user to check the product
Pay attention to the instructions for use when handling the lamp.
These Instructions for use are part of the product and must therefore
be stored in a place close to the product in order for the safety in-
structions and important information to be consulted at any time.
Make sure that the lamp is in satisfactory working order before every
use. If there is obvious damage, unusual operating conditions, etc.,
the lamp must not be used.
1.3 Availability of the instructions for use
These instructions for use and a detailed manual with further tips on
how to use the light can be found online at the following link:
https://dr-mach.de/login/mach-led-150.html
1.4 Intended use / contra-indications
The Mach LED 150 operating light is designed to illuminate an oper-
ating site in medical facilities (e.g. in a laboratory, in hospitals or doc-
tor's practice) with focused, low-glare, shadow-free light. It enables
the user to perform a diagnosis or carry out medical interventions.
The Mach LED 150 light is an operating light that is not fail-safe when
used as a single light. This device is not designed to operate in areas
which are subject to explosions.
Continuous illumination of the open human eye should be avoided
when illuminating the face area.
1.5 Technical data
Class of protection
I
IP protection class
IP 42
Input voltage
(power supply)
100-240 V AC, 50/60 Hz
Input voltage
(light body)
24 V DC
Power consumption
24 W
29 W (Mach LED 150 MC P)
Current
1.0 A max
1,2 A max. (MC P)
Examination time
Continuous operation possible
Expected life
1
10 years
1
At the end of the expected (designed) service life, the lamp must be ser-
viced more frequently for safe operation (see the manual for details).
1.6 Lighting technical data
Mach LED
150F
Mach LED
150
Mach LED
150FP
Mach LED
150MC
Mach LED
150MC P
Central illumi-
nance (distance 1
m)
110.000
Lux
110.000
Lux
130.000
Lux
110.000
Lux
130.000
Lux
Light field diame-
ter d10
163 mm
187 mm
157 mm
206 mm
205 mm
Light field diame-
ter d50
85 mm
104 mm
83 mm
113 mm
112 mm
Residual light in-
tensity (one
shadower)
0 %
0 %
0 %
0 %
0 %
Residual light in-
tensity (two shad-
owers)
52 %
46 %
53 %
46 %
45 %
Residual light in-
tensity (normed
tube)
100 %
100 %
100 %
100 %
100 %
Residual light
density (normed
tube, one shad-
ower)
0 %
0 %
0 %
0 %
0 %
Residual light
density (normed
tube, two shad-
owers)
52 %
46 %
53 %
47 %
46 %
Depth of illumina-
tion (20%)
1800 mm
1544 mm
1800 mm
1755 mm
1740 mm
Depth of illumina-
tion (60%)
822 mm
803 mm
814 mm
855 mm
870 mm
Radiation inten-
sity in the field
(distance 1 m)
439 W/m
2
406 W/m
2
489 W/m
2
393 W/m
2
471 W/m
2
Radiation inten-
sity in the field
572 W/m
2
(0,78 m)
551 W/m
2
(0,77 m)
591 W/m
2
(0,81 m)
583 W/m
2
(0,73 m)
695 W/m
2
(0,72 m)
For a complete overview of technical and lighting specifications, refer
to the manual.
1.7 Installation/Maintenance/Repair
The lamp may only be installed, maintained or repaired by the man-
ufacturer or by specially trained staff. Maintenance must be carried
out at least every two years
1.8 Environmental conditions for operation
Ambient temperature: +10°C to + 30°C
Relative air humidity 30% to 75% RH
Air pressure 700 hPa to 1060 hPa
1.9 Reporting obligations
All serious incidents which have occurred in connection with the prod-
uct must be reported to the manufacturer and the competent author-
ity.
2. Images on the device
This symbol indicates that the instructions
for use must be followed.
Serial number of the product
Part number of the product
Address of the manufacturer
Date of manufacture and country of manu-
facture
EC conformity symbol
This symbol indicates that this is a medical
device