EN
User manual - English
59161001
6 / 70
Mach LED 2
V2
2022-01-21
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
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.
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/m
2
) 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.
Simultaneous touching of parts on the luminaire
and the patient is not permitted.
4. Operating the Mach LED 2 light
ON/OFF switch of the light
Activates or deactivates the depth light
Activates or deactivates the laser
