Dr. Mach LED 6MC - Safe Use Instructions; Intended User; User Obligations for Product Checks; Accessing User Manuals

EN
User manual - English
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Mach LED 6MC
V3
2022-03-24
Congratulations on acquiring a new MACH LED 6MC operating
light.
Please read these Instructions for use very carefully.
1. Instructions for safe use
1.1 Intended user
The Mach LED 6MC 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 handbook with detailed in-
formation on how to deal with a fault, a list of accessoires and further
tips on how to use the light can be found online at the following link:
https://dr-mach.de/login/mach-led-6mc.html
1.4 Intended use / contra-indications
The Mach LED 6MC operating light is designed to illuminate an op-
erating site in medical facilities (e.g. in a laboratory, in hospitals or
doctor's practice) with focussed, low-glare, shadow-free light. It ena-
bles the user to perform a diagnosis or carry out medical interven-
tions. The Mach LED 6MC 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 surgical equipment.
Permanent illumination of the open human eye should be avoided
when illuminating the face area.
1.5 Technical data
Class of pro-
tection
I
IP protection
class
IP 54 (light body without camera preparation)
IP 53 (light body with camera preparation)
Input voltage
(power supply)
100-240 V AC, 50/60 Hz
Input voltage
(light body)
24-30 V DC
Power con-
sumption /
Current
Standard
140.000 Lux
Optional
160.000 Lux
62 W / 2,6 A max.
(without KV)
73 W / 3,1 A max.
(without KV)
83 W / 3,5 A max.
(without KV, with S)
95 W / 4,0 A max.
(without KV, with
S)
60 W / 2,5 A max.
(with KV, without S)
73 W / 3,1 A max.
(with KV, without
S)
83 W / 3,5 A max.
(with KV, with S)
97 W / 4,1 A max.
(with KV, with S)
69 W / 2,9 A max.
(with camera, without
S)
82 W / 3,5 A max.
(with camera, with-
out S)
92 W / 3,9 A max.
(with Kamera, with
S)
106 W / 4,5 A max.
(with Kamera, with
S)
Operating time
Continuous operation possible
Expected life
(1)
10 years
KV: camera preparation; S: shade management
1
At the end of the expected (designed) service life, the lamp must be serviced
more frequently for safe operation (see the manual for details).
1.6 Lighting technical data
Mach LED
6MC
Mach LED
6MC KV
a
Central light intensity
(distance 1 m)
140,000 lux
(optional
160,000 lux)
140,000 lux
(optional
160,000 lux)
Light field diameter d10
180 mm
180 mm
Light field diameter d50
103 mm
103 mm
Residual light intensity
(one shadower)
50%
50%
Residual light intensity
(two shadowers)
45%
b
58%
c
41%
b
53%
c
Residual light intensity
(normed tube)
100%
100 %
Residual light intensity
(normed tube, one shad-
ower)
50%
50 %
Residual light intensity
(normed tube, two shad-
owers)
45%
b
58%
c
41 %
b
53 %
c
Illumination depth (20%)
2000 mm
1680 mm
Illumination depth (60%)
1050 mm
1010 mm
Radiation intensity in the
field
(distance 1 m)
518 W/m
2
558 W/m
2 d
500 W/m
2
567 W/m
2 d
Max. radiation intensity
in the field
(distance 0.69 m)
723 W/m
2
757 W/m
2 d
673 W/m
2
763 W/m
2 d
a
KV refers to the model with camera preparation, the lighting specifications
have been determined for a light with a built-in camera.
b
Without shade management system
c
With shade management system (optional)
d
Mach LED 6MC with 160,000 lux (optional)
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 indicates that the instructions
for use must be followed.