Dr.Mach LED 2SC Manual De Instrucciones página 5

EN User manual - English
Congratulations on acquiring a new Mach LED 2SC operating
light.
Please read these Instructions for use very carefully.
1. Instructions for safe use
1.1 Intended user
The Mach LED 2SC 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-2.html
1.4 Intended use / contra-indications
The Mach LED 2SC 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 focussed, low-glare, shadow-free light. It enables
the user to perform a diagnosis or carry out medical interventions.
The Mach LED 2SC light is an operating light that is not fail-safe when
used as a single light. It is not intended for use in areas where explo-
sions are likely although it is permissible to use it in the vicinity of HF
surgical equipment.
Permanent illumination of the open human eye should be avoided
when illuminating the face area.
59161004
1.5 Technical data
Class of protection I
IP protection class IP 42
Input voltage 100-240 V AC, 50/60 Hz
(power supply)
Input voltage 24-30 V DC
(light body)
Power consumption 30 W
Current 1.25 A max.
Operating 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 light intensity
(distance 1 m)
Light field diameter d10
Light field diameter d50
Residual light intensity (one
shadower)
Residual light intensity (two
shadowers)
Residual light intensity (normed
tube)
Residual light intensity (normed
tube, one shadower)
Residual light intensity (normed
tube, two shadowers)
Illumination depth (20%)
Illumination depth (60%)
Radiation strength in the field
(distance 1 m)
Max. radiation strength in the
field
(distance 0.80 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
Every serious incident which has occurred in connection with the
product must be reported to the manufacturer and the competent au-
thority.
2. Images on the device
Mach LED 2SC
115,000 lux
170 mm
100 mm
33%
48%
100%
33%
48%
1200 mm
600 mm
2
408 W/m
2
557 W/m
Mach LED 2SC
+5°C to +40°C
30% to 75% RH
700h Pat o 1060h Pa
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
This symbol indicates that this is a medical
device.
Unique device identifier (ID) of the product
V1 2021-05-21