Dr. Mach LED 300 User manual

59171001
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Mach LED 300
V5
2023-01-30
Mach LED 300
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MedEnvoy Switzerland
Gotthardstrasse 28
6302 Zug, SWITZERLAND
Dr. Mach GmbH & Co. KG
Am Brucker Feld 4
85567Grafing, GERMANY
Tel. [phone]
Fax [phone]
www.dr-mach.de
[email protected]

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User manual - English
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Congratulations on acquiring a new Mach LED 300 operating
light.
Please read these Instructions for use very carefully.
1. Instructions for safe use
1.1 Intended user
The Mach LED 300 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 a list of ac-
cessoires and furthertips on how to use the light can be found online
at the following link:
https://dr-mach.de/login/mach-led-300.html
1.4 Intended use / contra-indications
The Mach LED 300 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 300 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.
1.5 Technical data
Class of protection
I
IP protection class
IP 42
Input voltage
(power supply 200W /
190W)
100-240 V AC, 50/60 Hz
Input voltage
(light body)
24-30 V DC
Power consumption
32 W (Mach LED 300DF SC
Spot)
46 W (Mach LED 300DF SC -
camera preparation)
53 W (Mach LED 300DF SC -
camera)
32 W (Mach LED 300MC -
camera preparation)
39 W (Mach LED 300MC -
camera)
Current
2.0 A max.(Mach LED 300DF
SC Spot)
2.0 A max. (Mach LED 300DF
SC - camera preparation)
2.3 A max. (Mach LED 300DF
SC - camera)
1.3 A max. (Mach LED 300MC
- camera preparation)
1.7 A max (Mach LED 300MC
- 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
300DF SC
Mach LED
300DF SC
Spot
Mach LED
300MC
Central light
strength (dis-
tance 1 m)
160,000
lux
160,000
lux
160,000
lux
Light field diame-
ter d10
189 mm
185 mm
184 mm
Light field diame-
ter d50
100 mm
97 mm
104 mm
Residual light in-
tensity (one
shadower)
41 %
38 %
44 %
Residual light in-
tensity (two
shadowers)
42 %
47 %
44 %
Residual light in-
tensity (normed
tube)
100 %
100 %
100 %
Residual light in-
tensity (normed
tube, one shad-
ower)
41 %
38 %
44 %
Residual light in-
tensity (normed
tube, two shad-
owers)
42 %
47 %
44 %
Illumination
depth (20%)
965 mm
1520 mm
915 mm
Illumination
depth (60%)
552 mm
628 mm
510 mm
Radiation inten-
sity in the field
(distance 1 m)
584 W/m2
582 W/m2
574 W/m2
Max. radiation in-
tensity in the
field (distance
0.94 m)
588 W/m2
-
-
Max. radiation in-
tensity in the
field (distance
0.90 m)
-
-
674 W/m2
Max. radiation in-
tensity in the
field (distance
0.85 m)
-
602 W/m2
-
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

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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
EC conformity symbol
This symbol indicates that this is a medical
device.
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.
Simultaneous touching of parts on the luminaire
and the patient is not permitted.

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4. Operating the Mach LED 300 light
ON/OFF switch of the light
(To turn off the lamp, press and hold the
(ON/OFF) button for one second.)
Regulation of the brightness
Switching on the endoscopy mode
Regulation of electronic focus
Adjustment of the color temperature
5. Operating the camera remote control
Camera controls:
ON/OFF:
Switch between operation
and stand-by
Rotate:
Rotate video image
Zoom:
Magnification of the video
image
White balance:
adjusting the colour tempera-
ture to the actual environ-
ment
Still image
Focusing:
Autofocus –Switch on/off
Near/far –Adjust to near or
far objects
Exposure
AE –Switching the auto-
matic exposure control
on/off.
Sun/Moon –Increase or de-
crease the brightness
6. Operating the Mach LED 300 manual remote
control
Light's ON/OFF switch
Transfers the settings of light intensity, col-
our temperature, focus and endo-mode to
other lights
Adjustment of light intensity
Adjustment of the electronic
focussing
Adjustment of the colour temperature
7. Pairing
Option A: Pairing manual remote lamp con-
trol
Start pairing by pressing and holding (min.
3 sec.) of the key combination 1 (+), 2 (-)
and 3 (ON/OFF)
Flashing LED 2 and LED 3 –pairing mode
activated
Press any key of the remote control to
transmit Sync address and WCOM ad-
dress to the lamp
Note: No other hand-held remote control
may be active or activated during pairing
Further information and overview of SYNC
and WCOM addresses can be found in the
manual for downloading - Link see Chapter
1.3
Option B: Pairing Camera
Radio receiver connection:
Pull the top cover 3upwards
Insert receiver module 4into the wall
bracket
Radio receiver is now in configuration
mode - green status LED 3 flashes contin-
uously for approx. 1 minute
After one minute radio receiver is in normal
operating mode - (green LED 3 flashes
briefly)
Connect the monitor or other compatible
device (recording device, splitter, etc.) with
an HDMI cable to the HDMI connection 4
of the wall bracket.
Connect the power cable to connector 5
1. Switch on the camera with the remote control with the
ON/OFF button in standby mode (permanently lit yel-
low LED in the camera)
2. Press the red button on the radio receiver and hold it
pressed for at least 5 seconds (yellow LED flashes
quickly)
3
1
2

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3. Press freeze button of the remote control camera
(facing the camera) five times in a row within 15 sec. -
yellow LED of the camera flashes - pairing starts
4. Pairing takes a few minutes; after completion, the yel-
low LED in the camera and the blue LED on the radio
receiver are lit continuously
5. Switch on the camera using the remote control - if
there is a picture on the monitor - pairing successful;
no picture on the monitor - repeat the procedure
Status of the radio link by displaying the
blue LED 6:
- LED lights up permanently: radio connec-
tion stable and permanent
- LED flashes quickly: Radio connection
established, but video not displayed on
monitor - check monitor cable
- LED flashes slowly: No radio connection
established
8. 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 theman-
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.
9. 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, disconnectthe 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.
10.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
300 operating light has been tested for use in professional equipment
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.
11.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.