Dr. Mach Mach LED 8MC User manual

59351001
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Mach LED 8MC
V5
2023-01-30
Mach LED 8MC
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MedEnvoy Switzerland
Gotthardstrasse 28
6302 Zug, SWITZERLAND
Dr. Mach GmbH & Co. KG
Am Brucker Feld 4
85567 Grafing, GERMANY
Tel. [phone]
Fax [phone]
www.dr-mach.de
[email protected]

EN
User manual - English
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Mach LED 8MC
V5
2023-01-30
Congratulations on acquiring a new Mach LED 8MC operating
light.
Please read these Instructions for use very carefully.
1. Instructions for safe use
1.1 Intended user
The Mach LED 8MC 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-8mc.html
1.4 Intended use / contra-indications
The Mach LED 8MC 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 8MC 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 protection
I
IP protection class
IP 54 (light body without cam-
era 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 consumption / cur-
rent
80 W / 3,3 A (without S)
82 W / 3,4 A (with S)
90 W / 3,7 A (without S, with
camera)
92 W / 3,8 A (with S
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
8MC
Mach LED
8MC KV a
Central light intensity
(distance 1 m)
160,000 lux
160,000 lux
Light field diameter d10
188 mm
190 mm
Light field diameter d50
103 mm
104 mm
Residual light intensity
(one shadower)
68 %
75 %
Residual light intensity
(two shadowers)
53 % b
68 % c
47 % b
58 % c
Residual light intensity
(normed tube)
100 %
100 %
Residual light intensity
(normed tube, one shad-
ower)
68 %
75 %
Residual light intensity
(normed tube, two shad-
owers)
53 % b
68 % c
47 % b
58 % c
Illumination depth (20%)
1890 mm
1540 mm
Illumination depth (60%)
900 mm
870 mm
Radiation intensity in the
field
(distance 1 m)
576 W/m2
574 W/m2
Max. radiation intensity
in the field
(distance 0.73 m)
694 W/m2
665 W/m2
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)
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.
Serial number of the product
Part number of the product
Address of the manufacturer
Date of manufacture and country of manu-
facture

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EC conformity symbol
This symbol indicates that this is a medical
device.
Unique device identifier (ID) of the product
LASER CLASS 2
The lamp can be equipped with a laser.
NRTL Test mark
The lamp is tested by a ‘Nationally Recog-
nized Testing Laboratory’
Reference to China RoHS /
pollution control logo
Positioning arrows
Instruction for disposal of the device
3. Safety instructions
This symbol indicates possible sources of danger.
Please also note the safety instructions and the
hazard specification in the associated installation
and operating instructions for the support arm sys-
tem.
Pay attention to the instructions for use when han-
dling the lamp.
Warning: to avoid the risk of an electric shock, this
device must only be connected to a supply network
that has a protective earthing conductor.
A primary-side ON/OFF switch to isolate the sys-
tem from the supply network must be provided on
site. The switch must meet the requirements of IEC
61058-1 for nominal voltage peaks of 4 kV.
This device is not designed for operation in envi-
ronments enriched with oxygen.
The lamp may only be used for the intended pur-
pose. Otherwise, the manufacturer will not be liable
for personal injury or damage to property.
The lamp is equipped with a sterilizable handle at
the factory and must only be used with this handle.
Changes to the light are prohibited and will invali-
date the manufacturer's certificate of conformity
and all warranty claims.
Use only the mains units (or transformers) ap-
proved or supplied by the manufacturer. Non-ob-
servance will void the conformity of the product and
release the manufacturer from any claims under
warranty.
Installation, maintenance and repair work may only
be carried out by the manufacturer or by specially
trained staff.
Maintenance must be carried out on the light at
least every two years
Additional equipment that is connected to medical
electrical equipment, must conform to the relevant
IEC- or ISO standards (e.g. IEC 60950 or IEC
62368 for data processing equipment). Moreover,
all configurations must meet the requirements for
medical electrical systems (see Section 16 of the
latest version of IEC 60601-1). Anyone who con-
nects additional equipment to medical electrical
equipment, is configuring a medical system and is
therefore responsible for ensuring that the system
meets the requirements for medical electrical sys-
tems. In case of doubt, contact your local repre-
sentative or our technical customer services.
The simultaneous use of several lights to illuminate
a wound area may result in the maximum allowed
energy input being exceeded (1,000 W/m2) and
thus excessive heat development. It is the user's
responsibility to ensure that the maximum allowed
limit is not exceeded.
The unprotected human eye can be damaged by
direct light. Do not look directly into the light beam
of the lamp. Do not point the light beam at the pa-
tient's unprotected eye continuously.
Do not allow the laser beam to enter the eyes of
the patient or user. The eyelid closing reflex of pa-
tients, in particular, may be impaired by this.
When positioning the light body, there is a risk of
injury (e.g. crushing) and collisions with other ob-
jects (inventory) or walls.
Parts that fall off could injure the patient or lead to
an infection of the wound area.
Do not remove the rating plate or the warning la-
bels.
It is forbidden to carry out servicing or repair activi-
ties whilst the lamp is in use.
Lights with the camera preparation equipment may
only be used with the camera or camera bay cover
installed.
Simultaneous touching of parts on the luminaire
and the patient is not permitted.
4. Operating the Mach LED 8MC light
ON/OFF switch of the light
(To turn off the lamp, press and hold the
(ON/OFF) button for one second.)
Activates or deactivates the depth light

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Activates or deactivates the shade man-
agement system
Activates or deactivates the laser (press
for one second to activate)
Transfers the adjustments of light inten-
sity, colour temperature, focus, shade
management and Endo-mode to other
lights (optional)
Activation or deactivation of Endo-mode
(reduced light for endoscopy applica-
tions)
Regulation of the electronically adjusta-
ble light field size
Adjusts the light intensity
Adjusts the colour temperature
The handle symbol shows which function
is currently being operated via the ring
on the handle
Shows the relative size of the adjusted
light field
Shows the light intensity
Shows the light temperature in Kelvin
Indicates an error with error code and
description
5. Cleaning and disinfecting
Cleaning and disinfecting work must only be done by trained
staff. The respective requirements must be observed for all
cleaning and disinfection work (details can be found in the man-
ual).
Housing/protective screen
The housing and the protective screen of the lamp body can be
cleaned and disinfected with many common/commercially available
materials. Do not use cleaning agents or disinfectants contain-
ing active substances based on biguanides or phenols. Cameras
must be removed and the camera bay cover put on prior to cleaning
and disinfection.
Furthermore, only cleaning agents approved for polycarbonate (PC)
may be used to clean the protective screen. To protect against me-
chanical damage, always use a damp cloth (never a dry one) to wipe
the protective screen and after cleaning, wipe with an anti-static
agent (lint-free cloth).
Sterilisable handle
The handle must be cleaned/disinfected before each use. It can be
steam sterilised (max. 200 sterilisation cycles for max. 5 minutes at
a max. temperature of 134°C; details can be found in the manual).
Before installing the handle, check it for visible damage, fouling
and the specified manufacturing date. Do not use damaged or
dirty handles or handles that are more than two years old.
6. Faults
In the event of unusual operating conditions or a fault message dis-
played on the display, the lamp must not be used, as safe operation
cannot be guaranteed. For troubleshooting, disconnect the lamp from
the mains for about 30 seconds. In the event of continuous faults, a
suitably trained service technician must be contacted, stating the er-
ror code.
7. Information on electromagnetic compatibility
Medical electrical equipment is subject to special precautionary
measures with regard to electromagnetic compatibility (EMC). They
may only be installed and put into service in accordance with the
EMC instructions in the accompanying documents. The Mach LED
8MC operating light has been tested for use in professional equip-
ment of the health care system.
The lamp is suitable for use with an RF surgi-
cal device. There must be a distance of at least
50 cm between the surgical light, including the
suspension system, and the RF electrode ca-
bles.
Portable and mobile RF communications
equipment can affect medical electrical equip-
ment and must not be used within30 cm of the
light, including the cable.
The use of this equipment immediately next to
other equipment or with other equipment in
stacked form should be avoided since this may
result in faulty operation. Should use in the
aforementioned manner nevertheless be nec-
essary, this device and the other equipment
should be kept under observation to ensure
that they are working properly.
The useof different accessories,converters or
cables to those that the manufacturer of this
device has stipulated or made available may
result in increased electromagnetic interfer-
ence or reduced immunity to electromagnetic
interference and to faulty operation.
Furthermore, the light must not be operated if
the housing, cable or electromagnetic shield-
ing is damaged.
Additional information on electromagnetic compatibility can be
found in the manual.
8. Disposal
The light does not contain any harmful sub-
stances. The components of the light should
be disposed of appropriately at the end of
the product's life.
Take care that the material is carefully sep-
arated: The electrical circuit boards should
be recycled appropriately. The housing of
the light and the other components should
be disposed of according to the materials
they contain.