Dr. Mach LED 3 - Instructions for Safe Use

EN
User manual - English
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Mach LED 3
V1
2021-05-03
Congratulations on acquiring a new Mach LED 3 operating light.
Please read these Instructions for use very carefully.
1. Instructions for safe use
1.1 Intended user
The Mach LED 3 is a Class I medical product and may only be oper-
ated 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-3.html
1.4 Intended use / contra-indications
The Mach LED 3 operating light is designed to illuminate an operating
site in medical facilities (e.g. in a laboratory, in hospitals or doctor'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 3 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 explosions
are likely although it is permissible to use it in the vicinity of HF sur-
gical equipment.
Permanent 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)
24-30 V DC
Power consumption
(Mach LED 3SC)
45 W (without camera)
50 W (with camera)
Power consumption
(Mach LED 3 Smart)
60 W (without camera)
65 W (with camera)
Current
(Mach LED 3SC)
1.7 A max.(without camera)
1.9 A max.(with camera)
Current
(Mach LED 3 Smart)
2.5 A max.(without camera)
2.7 A max.(with camera)
Operating 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
3SC
Mach LED 3
Smart
Central light intensity
(distance 1 m)
140,000 lux
140,000 lux
Light field diameter d10
170 mm
170 mm
Light field diameter d50
100 mm
100 mm
Residual light intensity
(one shadower)
63%
61%
Residual light intensity
(two shadowers)
49%
49%
Residual light intensity
(normed tube)
100%
100 %
Residual light intensity
(normed tube, one shad-
ower)
63%
61%
Residual light intensity
(normed tube, two shad-
owers)
49%
49%
Illumination depth (20%)
1200 mm
1200 mm
Illumination depth (60%)
510 mm
530 mm
Radiation intensity in the
field
(distance 1 m)
490 W/m
2
499 W/m
2
Max. radiation intensity
in the field
(distance 0.80 m)
770 W/m
2
-
Max. radiation intensity
in the field
(distance 0.89 m)
-
537 W/m
2
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: +5°C to +40°C
Relative air humidity: 30% to 75% RH
Air pressure. 700h Pat o 1060h Pa
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
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