Instructions For Safe Use - dr.mach Mach LED 110 Gebrauchsanweisung

EN User manual - English
Congratulations on acquiring a new MACH LED 110 examination
light.
Please read these Instructions for use very carefully.

Instructions for safe use

1.1 Intended user
The Mach LED 110 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-110.html
1.4 Intended use / contra-indications
The Mach LED 110 examination light is designed to illuminate an ex-
amination site in medical facilities (e.g. in a laboratory, in hospitals or
doctor's practice) with focused, low-glare, shadow-free light. It ena-
bles the user to perform a diagnosis or carry out medical interven-
tions. The Mach LED 110 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.
59131001
1.5 Technical data
Class of protection II
IP protection class IP 42
Input voltage 12 V DC
(light body)
Power consumption 5,5 W
Current 0.45 A
Examination time Continuous operation possible
1
Expected life 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
Central illuminance
(distance 0,5 m)
Central illuminance
(distance 1 m)
Light field diameter d10
(distance 0,5 m)
Light field diameter d10
(distance 1 m)
Light field diameter d50
(distance 0,5 m)
Light field diameter d10
(distance 1 m)
Residual light intensity (one
shadower)
Residual light intensity (two
shadowers)
Residual light intensity
(normed tube)
Residual light density (normed
tube, one shadower)
Residual light density (normed
tube, two shadowers)
Depth of illumination (60%)
Radiation intensity in the field
(distance 1 m)
Max. radiation in the field
(distance 0.41 m)
For a complete overview of technical and lighting specifications, refer
to the manual.
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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:
Relative air humidity
Air pressure
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.
Mach LED 110
30,000 lux
Images on the device
7,800 lux
105 mm
223 mm
58 mm
122 mm
0%
68%
100%
0%
68%
1250 mm
2
58 W/m
2
265 W/m
Mach LED 110
+5°C to +40°C
30% to 75% RH
700 hPa to 1060 hPa
This symbol tells the user to observe the
instructions for use.
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
Protection class II device
This symbol indicates that this is a medical
device
V1 2021-05-14