Dr. Mach Mach LED 500DF User manual

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page 1/26
Operating instructions
MACH LED 500DF
Dr. Mach GmbH u. Co. KG, Flossmannstrasse 28, D-85560 Ebersberg
Tel.: [phone], Fax [phone]
Internet: www.dr-mach.com, E-mail: [email protected]
Design with central reflector available against surcharge

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page 2/26
List of contents
1. Safety instructions ....................................................................................page 4
2. Brief description of the lamp Mach LED 500DF ........................................page 7
2.1 Operating the lamp Mach LED 500DF................................................page 8
2.1.1 Merging of light fields ................................................................page 8
2.1.2 Focusing....................................................................................page 8
2.1.3 Light intensity control.................................................................page 8
2.2 Turning the lamp ON/OFF ..................................................................page 8
2.3 Adjusting the illuminated area by........................................................page 9
merging of light fields and focusing –
Duo Focus system
2.4 Overview of the lamp functions...........................................................page 10
2.5 Adjusting the light intensity .................................................................page 11
2.6 Positioning ..........................................................................................page 12
2.7 Danger of collision while positioning the lights....................................page 13
3. Cleaning....................................................................................................page 14
3.1 Sterilisable handle ..............................................................................page 14
3.2 Lamp housing, dispersing lens and support system ...........................page 16
4. Maintenance .............................................................................................page 17
4.1 Maintenance work ..............................................................................page 17
4.2 Adjustments at the lamp head ............................................................page 18
5. Data ..........................................................................................................page 19
5.1 Technical data ....................................................................................page 19
5.2 Electrical data .....................................................................................page 20
5.3 Information regarding the electrical installation...................................page 20
5.4 Weights...............................................................................................page 20
5.5 Environmental conditions....................................................................page 21
5.6 General remarks.................................................................................page 21
6. CE-mark....................................................................................................page 22
7. Disposal ....................................................................................................page 22
8. Electromagnetic compatibility ...................................................................page 23

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page 3/26
Dear customer!
Congratulations for achieving our new OT-lamp MACH LED 500DF.
The new OT-light generation with LED technology supports your professiona-lity by innovative tech-
nology and design.
The advantages of the LED technology: adjustable light colour, a life-span of minimum 40.000 hours
and an almost non-existent heat development in the surgeon’s head area and in the wound field.
The advantages already provided by Dr. Mach’s light technology with halogen and gas discharge
lamps have been maintained: natural colour reproduction, exact illumination of the wound field and
easy positioning of the light head.
All information quoted here relates only to the illuminants. Details of ceiling or wall installation can be
found in the mounting instructions.

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page 4/26
1. Safety instructions
Pay attention to the instructions for use when handling the lamp.
WARNING:
This device has not been designed for use in potentially explosive areas.
According to the Medical Device Regulation the light is classified under class I.
Store the OT-light in its package for at least 24 hours in the respective room before mounting, in
order to equal temperature differences.
Please read the instructions for use carefully to make the most of your lighting system and to avoid
any damages to the device.
The lights may only be repaired and special assembly work may only be carried out on the
reflector or sockets by ourselves or a company that has been expressly authorised by us.
The manufacturer can only be made responsible for the safety of the light if repairs and alterations
are carried out by the manufacturer himself or a company that guarantees to observe the safety
regulations.
No modification of the lamp is allowed!
The manufacturer cannot be made liable for personal or material damages if the light is operated
inexpediently or incorrectly or used for purposes other than those for which it is intended.
The light is to be dismantled from the spring arm in reverse order to its assembly. This may only
be carried out after the spring arm has been adjusted in height at horizontal position since the
arm is under spring tension and can bounce up.
Make sure that the light is in perfect working order before every use.
Attention, external power supply!
The light works only with an external power supply 250VA or 200VA.
The external power supply used with the OT-light must be tested and validated according to
IEC 60601-1.
Attention!
Amain control switch must be installed for turning the system power-off. The switch must meet the
requirements of the standard IEC 61058-1 regarding rated voltage peaks of 4kV.
During the mounting of the OT-lights the entire system
(incl. the ceiling attachment) must be disconnected from mains!
A later dismounting of the lights from the spring arms or dismounting the sliding contacts inside the
arms is to be done ONLY AFTER DISCONNECTING THE ENTIRE SYSTEM FROM MAINS.
Otherwise the main control board will be damaged!

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page 5/26
Symbols and notes used in this user manual:
This symbol means possible hazard sources. Please observe also the safety remarks and
the hazard specifications mentioned in the mounting instructions and user manuals from
Ondal company.
This symbol means possible hazard caused by electric current. Please observe also the
safety remarks and the hazard specifications mentioned in the mounting instructions and
user manuals from Ondal company.
This symbol refers to important mounting indications, useful information and operation hints.
Temperature range for transport and storage
Indication for disposal

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page 6/26
Symbols and notes used on the device:
This symbol indicates to observe the user manual.
Alternating current
Bulb
Fuse
Protective conductor
Temperature range for transport and storage
Indication for disposal
Serial number of the product
Article number of the product
Address of manufacturer / distributor of the product

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page 7/26
2. Brief description of the lamp
Mach LED 500DF intended use:
The Mach LED 500DF lighting system is designed for illuminating an examination area and surgical field
at the hospital and doctor’s practice.
Mach LED 500DF indications for use:
The surgical light MACH LED 500DF is intended to illuminate the surgical field and the patient’s body with
a high intensity, shadow-free and “cold” light.
Essential Performance:
The OT-lights MACH LED 500DF are intended to provide the illumination in depth and to restrict the
energy on the operating field.
General product description :
The Mach LED 500DF lighting system is an OT-light according to EN 60601-2-41, which is not
fail-safe when used as a single light.
The light is used in medical rooms (groups 0, 1 and 2 according to DIN VDE 0100-710).
This light system can be added to the ceiling mounted suspension system supporting the horizon-
tal arms and spring arms.
The light system is operated by a keypad on the lamp.
The OT-lamp MACH LED 500 is available in following versions:
- Duo-Focus OT-lamp (DF) with merging of light fields, focusing and electronic light intensity control
- Duo-Focus OT-lamp (DF) with merging of light fields, focusing, electronic light intensity control and
additional central reflector for an improved depth illumination
Accessory
The accessories for the Mach LED 500DF lighting systems are as follows:
Camera module
Remote control for camera module
Single monitor yoke for flat panel monitors
Double monitor yoke for flat panel monitors
Instrument trays
24V DC battery backup support
Sterile handle sleeves

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page 8/26
2.1 Operating the lamp MACH LED 500DF
2.1.1 Merging of light fields
The lights offer light field adjustment by
merging the individual light fields of each LED-
cluster by swivelling them.
NOTE: This feature is activated by turning the
sterilisable handle.
2.1.2 Focusing
The DF-model offers a second additional
facility to further adjust the illuminated field to
an extra small or extra large size, depending
on the specific requirements, by focusing.
NOTE: This feature is activated by turning the
ring at the top of the sterilisable handle.
2.1.3 Light intensity control
The OT-lamp models LED 500DF offer a standard feature, the light intensity control.
You can adjust the light intensity between 50% and 100%, according to your requirements.

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page 9/26
2.2 Turning the lamp ON/OFF
The lights LED 500DF are switched ON/OFF at the
main switch of the OT or at the ON/OFF switch at the
cardan bow.
The lights LED 500DF are switched ON/OFF with the
touch-button 1at the key-pad of the lamp.
2.3 Adjusting the illuminated area by
merging the light fields and
focusing – Duo-Focus system
All lamp models LED 500DF offer the feature of
“merging the light fields” and “focussing”.
Merging of light fields is activated by turning the
sterilisable handle 2.
Focusing is activated by turning the ring 3at the
sterilisable handle.
1
2
3

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page
10/26
2.4 Overview of the lamp functions
Merging of light fields and focusing
Merging the individual light fields of each LED-cluster is
done by swivelling the reflectors. The light fields overlap.
This feature is activated by turning the sterilisable handle
(1).
By focusing you can further adjust the illuminated field to an
extra small or extra large size, depending on the specific
requirements.
This feature is activated by turning the ring (2) at the top of
the sterilisable handle.
Always activate merging of light fields first by turning the handle (1), then activate
focusing when necessary by turning the ring (2)
Ring (2)
Handle (1)
MERGING OF LIGHT FIELDS
FOCUSING
! !

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page
11/26
Key pad
2.5 Adjusting the light intensity
Select the desired light intensity before the
operation.
At these models the adjustment is done by the key-
pad at the cardan bow. The intensity can be infinitely
adjusted between 50% and 100%.
Press push button 2to increase the light intensity
and press push button 3to reduce the light intensity.
The light intensity set is shown by LED-display 1.
2
3
1

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page
12/26
2.6 Positioning
Use the sterile handle 2or the handle rails 1to
position the lamps.
Use the handle rail to position the lights before the
operation.
Use the sterile handle for positioning during the
operation. This handle can be removed for steriliza-
tion.
Remark:
Position the light only with the handle or the
special designed parts on the light housing
The working distance of the lamps is 0,6m to 1,5m.
Two or more lamps can be used for an intensive
illumination of large operation fields.
It is also possible to illuminate two operation fields
simultaneously.
1
2
1
1
0
0,6m
1,5m
1m

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page
13/26
2.7 Danger of collision while positioning
the lights
During positioning, eventual collisions between
the lights, spring arms and other devices must be
avoided.
Cover parts can get loose and fall down.

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page
14/26
3. Cleaning
3.1 Sterilisable handle
At delivery the lamp is equipped with the handle
sleeve 1. The handle sleeve is removable and
sterilisable. Before using the first time and before
every use the handle sleeve must be cleaned,
disinfected and sterilised.
The handle sleeve must be removed for sterilisation:
To remove press the lock V and pull off the
sterilisable handle sleeve 1while keeping the
lock pressed.
To attach, push on and slightly twist the handle
until the lock V engages securely.
Handles often become unsterile during an OP;
therefore always keep additional handles available
for exchange.
Cleaning / disinfection and sterilisation
Basics
Efficient cleaning / disinfection is an essential requirement for effective sterilisation of the handle.
Within the scope of responsibility for the sterility of the products it should be noted that only sufficiently
validated equipment and product specific processes are used for cleaning / disinfection and that the
validated parameters are complied with in every cycle.
In addition, the hospital / clinic hygiene regulations must be observed.
Remark:
The requirements of the national commitees (standards and directives) for hygienics and
disinfection must be observed.
Cleaning / disinfection
Cleaning and disinfection must be carried out immediately after use.
A mechanised process (disinfector) should be used for cleaning / disinfection. The efficiency of the
process used must be recognised and validated in principle (e.g. listed under disinfectants and
disinfection procedures tested and recognised by Robert-Koch-Institute / DGHM).
When using other procedures (e.g. a manual procedure), proof and process efficiency in principle must
be provided within the scope of validation.
Proof in principle of the suitability of the handles for efficient cleaning / disinfection was provided using a
cyclic cleaning system (Netsch-Bellmed T-600-IUDT/AN, programme 2 for small parts; code B).
It is not allowed to use agents / disinfectants, which contain the following substances, as these may
cause changes in the material:
- High-concentration organic and inorganic acids
- Chlorinated hydrocarbons
- 2-ethoxyethanol
1
V

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page
15/26
When cleaning / disinfecting, the following procedures must be followed:
Process Time (sec.)
Zone 1 Pre-rinse, external, cold, 10 – 15°C 45
Washing, acidic, external 35°C 120
Draining time 10
Re-rinse, external approx. 80°C *10
Draining time *15
Re-rinse, external approx. 80°C *15
Draining time 15
Zone 2 Washing, alkaline, external, 93°C 135
Draining time 10
Re-rinse, external, acidic, 90°C 10
Draining time 15
Re-rinse, external 90°C 15
Draining time 15
Zone 3 Drying, external 100 – 120°C 200
Zone 4 Drying, external 100 – 120°C 200
Door open / close & transport 60
(sluice discharge)
Cycle time overall ca. 290
5 minutes
* When occupying the disinfection zone (washing zone 2), the re-rinse and draining times will depend on
the respective objects being washed therein!
Sterilisation
Only previously cleaned and disinfected handles may be sterilised.
The handles are placed in a suitable sterilisation pack (one-way sterilisation pack, e.g. foil / paper sterili-
sation bags, single or double pack) in accordance with DIN EN 868 / ISO 11607 for steam sterilisation
and then sterilised.
Use only the sterilisation procedure listed below for sterilisation. Other sterilisation procedures
(e.g. ethylene oxide, formaldehyde and low-temperature plasma sterilisation) are not permissible.
Steam sterilisation procedure
Validated in accordance with DIN EN 554/ISO 11134
Maximum sterilisation temperature 134°C
Proof in principle of the handles’ suitability for effective sterilisation was provided using a fractional
vacuum process (Euroselectomat 666 by MMM Münchner Medizin Mechanik GmbH, sterilising
temperature 134°C, holding time 7 min.)

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page
16/26
Inspection / durability
The sterilisable handle sleeve must be disposed
after 1000 sterilisation cycles or at the latest after
2 years and replaced with a new one.
The year of manufacture can be determined with
the help of a stamping on the inner side of the
handle sleeve (like shown in the photo). The
stamping in the photo shows the number 12,
which stands for the year 2012.
3.2 Lamp housing, protective disk
and support system
The OT-lamp MACH LED 500DF has a high-quality
surface, which can be cleaned with conventional
cleaning agents.
The protective disks 2are made of a high-quality
plastic. Pay attention to the following during clean-
ing:
- Never wipe over the protective disks 2with a dry
cloth (always clean with a wet cloth).
Wipe the protective disks 2after cleaning with
an antistatic, non-fluffy cloth.
2

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page
17/26
4. Maintenance
MACH LED 500DF lights are supplied with brakes on the suspension fixture and on the lamp housing.
Adjust these brakes, if necessary, after installation.
Preventive maintenance of the light should be done every two years. This includes a technical and
mechanical check-up.
Please observe also the mounting instructions and instructions for the carrying systems. These
instructions can contain statements for different maintenance intervals.
Attention:
Set the height adjustment, if applicable, of the spring arm to horizontal position before
dismounting the lamp. Please observe also the mounting instructions and instructions for the
carrying systems.
Attention: During all maintenance work the light must be disconnected from mains and
secured against resetting.
4.1 Maintenance work
The following maintenance work / tests has / have to be done:
check on defects in paint work;
check on fissures at plastic parts;
check on deformation of the suspension.
check on loosened parts;
check the connection between light and carrying system;
check and grease the securing segment;
check the faultless function of the light;
perform the electrical safety tests
For adjustments at the ceiling attachment please observe also the mounting instructions
“Ceiling attachment with heavy central axis” or “Ceiling attachment – wall attachment”
from Dr. Mach.
Remark:
Wiring diagrams, complete spare parts lists and maintenance manuals can be provided on
request.
It is not allowed to exchange spare parts and make repair work while the light is in operation.
It is not allowed to touch parts below the housing cover and to touch the patient at the same time.

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page
18/26
4.2 Adjustments at the lamp head
The fine adjustment for handling the lamps can be
carried out at points 2and 3.
To adjust the brakes use a screw driver with
appropriate size.
If you cannot adjust the brakes at points 2and 3
anymore as tight as necessary, you will have to
replace them.
2
3
Upper housing part

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page
19/26
5. Data
5.1 Technical data
Mach LED 500DF Mach LED 500DF with Spot
Central light intensity
at a distance of 1 meter 160.000 Lux 160.000 Lux
Light field diameter d10 150 mm 150 mm
Light field diameter d50 80 mm 80 mm
Light intensity with one shadower 70 % 63 %
Light intensity with two shadowers 50 % 55 %
Light intensity on the ground of anormed tube 97 % 95 %
Light intensity on the ground of a
normed tube with one shadower 64 % 55 %
Light intensity on the ground of a
normed tube with two shadowers 47 % 49 %
Illumination depth 20 % 550 mm 1380 mm
Illumination depth 60 % 290 mm 310 mm
Colour rendering index Ra95 95
Colour rendering index R9≥90 ≥90
Radiation in field
in a distance of 1 meter 563 W/m² 562 W/m2
Max. radiation in field
in a distance of 1 meter 563 W/m² 562 W/m2
Focussable size of the light field 15-30 cm 15-30 cm
Colour temperature (Kelvin) 4500 K 4500 K
Temperature increase
in head area 0,5 °C 0,5 °C
Number of LED’s 57 57
Life span of LED’s ≥40.000 h ≥40.000 h
Light head diameter 80 cm 80 cm
Remark:
The technical data are subject to fluctuations. Due to manufacturing reasons the real values can slightly
differ from the data mentioned above.
The values for Racan differ with approx ± 5%.
The values for the colour temperature can differ with approx ± 200K.

Mach LED 500DF Dr. Mach
Lamps and Engineering
59190002 Edition 05 15.09.2014 / Bak We page
20/26
5.2 Electrical data
Mach LED 500DF
Power consumption 70 W
Operating voltage DC 24-30 V
Current 2,9 A
Class of protection I.
5.3 Information regarding the electrical installation
When turned ON, the OT-light MACH LED 500DF is exposed to a current peak.
The OT-light MACH LED 500DF is delivered with a Dr. Mach power supply.
It is an electronic power supply with a wide-range input, input voltage 100 – 240V AC, 50 – 60Hz, output
voltage 28V DC.
In case there is a switch-over relay needed for an emergency power supply on site, this switch over relay
must be ordered separately at Dr. Mach.
In case of a power supply provided by the customer, the following points must be observed:
The OT-light works with 24V – 30V DC (direct voltage).
The direct voltage provided by the hospital must have a maximum undulation of 5%.
A higher voltage (28V – 30V DC) is recommended, this causes a decrease in heat development
of the light.
Warning!
The light is class I. equipment. In order to avoid the risk of an electric shock, the equipment must
be connected to a mains supply with protective earth.
5.4 Weights
Light Weight
Mach LED 500DF 20,5 kg*
* without handle