KLS Martin group marLED V10 User manual

Operating Lights marLED
®V10/V16
Instructions for Use
EN
V. 1.3 (2014-01)
90-743-52-13
Valid from
release SW 14
and
release HW 21

2 V. 1.3
Symbol explanation
Safety alert symbol
CAUTION Indicates a situation which, if not avoided, could result in
minor or moderate injury.
WARNING Indicates a situation which, if not avoided, could result in
death or serious injury.
DANGER Indicates a situation which, if not avoided, will result
in death or serious injury.
Follow Instructions for use
Follow Instructions for use
Reference number for ordering Gebrüder Martin products (item number)
Warning: Laser radiation!
Serial number
Store in a dry place
Information on minimum and maximum temperature for storage and
transportation.
See section 12 “Technical Data”, page 34 for valid values.
Information on minimum and maximum atmospheric pressure for storage
and transportation.
See section 12 “Technical Data”, page 34 for valid values.
Information on minimum and maximum atmospheric humidity for storage
and transportation
See section 12 “Technical Data”, page 34 for valid values.
Fragile, avoid pressure and shock

Instructions for Use
Operating Lights marLED®V10/V16
V. 1.3 3
Stacking height max. 2 layers, max. load 250 kg per item
Manufacturer
CE mark of conformity
Warning: Dangerous high voltage!
This product may not be disposed of as normal household garbage,
see section 16.3 “Disposal of the Device”, page 42.

Instructions for Use
Operating Lights marLED®V10/V16
4 V. 1.3
Contents
Terms & Acronyms .................................................................................. 6
1Product Liability and Warranty ...................................................... 7
1.1 General Information ..............................................................................7
1.2 Intended Use........................................................................................7
1.3 Warranty .............................................................................................9
1.4 User’s Inspection ..................................................................................9
1.5 Hotline............................................................................................... 10
2Notices Concerning this Document................................................10
2.1 Validity of this Document ..................................................................... 11
2.2 Symbols Used in this Document............................................................ 11
3Safety Notices............................................................................12
3.1 General Information ............................................................................ 12
3.2 Pilot Laser (Option) ............................................................................. 13
3.3 Personal Protection ............................................................................. 14
3.4 Operation........................................................................................... 15
3.5 Cleaning and Infection Protection.......................................................... 16
4Light Models and Combination Options..........................................17
4.1 Light Models.......................................................................................17
4.2 Light Combinations .............................................................................17
5Description of the Lights .............................................................18
5.1 LED Technology .................................................................................. 18
5.2 Starting Performance...........................................................................18
5.3 Options.............................................................................................. 18
5.3.1 Additional Safety Power Supply (ASPS) .............................................................18
5.3.2 Cameras SurgiCam® digital, SurgiCam® HD .......................................................19
5.3.3 Gebrüder Martin Pilot Laser .............................................................................19
6Operating the Lights ...................................................................20
6.1 Mounting the Sterilizable Handle ........................................................... 20
6.2 Operation via the sensoTouch Control Panel ........................................... 20
6.3 Using the Sterilizable Handle (sensoGrip) for Light Control ....................... 22
6.4 Using the Optional Wall Control Panel for Operation ................................ 23

Instructions for Use
Operating Lights marLED®V10/V16
V. 1.3 5
7Replacing Components................................................................24
7.1 Replacing the Sterilizable Handle .......................................................... 24
7.2 Handle for Sterile Disposable Covers (Optional) ...................................... 25
7.2.1 Replacing the Sterile Disposable Cover..............................................................25
7.3 Replacing Light Sources ....................................................................... 25
8Accessories................................................................................26
9Cleaning and Disinfecting the Light...............................................27
9.1 General Information ............................................................................ 27
9.2 Cleaning the Light’s Externally Accessible Parts....................................... 28
9.3 Manual Disinfection of Externally Accessible Parts ................................... 29
9.3.1 Wipe Disinfection ...........................................................................................29
9.4 Machine Disinfection and Sterilization of the Handles............................... 30
10 Maintenance ..............................................................................32
10.1 Regular Checks to Be Carried out by Owner/Operator.............................. 32
10.2 Maintenance to Be Performed by Manufacturer ....................................... 32
11 Troubleshooting .........................................................................33
12 Technical Data ...........................................................................34
12.1 Technical Data for marLED®V10/V16 .................................................... 34
13 Serial Number Structure..............................................................36
14 Safety Checks (SC) ....................................................................37
15 Guidelines and Manufacturer’s Declaration Regarding
Electromagnetic Compatibility (EMC) ............................................38
16 Ecological Information ................................................................42
16.1 Disposal of Packing .............................................................................42
16.2 Ecological Aspects of Operation............................................................. 42
16.3 Disposal of the Device ......................................................................... 42

Instructions for Use
Operating Lights marLED®V10/V16
6 V. 1.3
Terms & Acronyms
Designation Description
ASPS Additional safety power supply (battery)
backLite Brightness regulation 2 % for endoscopic background illumination
Cardanic system Light head suspension up to spring arm, with one or more cardan joints
Fully cardanic Cardanic system with 2 cardan joints, rotatable in 3 axes
LC cardanic Low-ceiling cardanic suspension: simplified cardanic system with one cardan
joint, rotatable in 2 axes, for use in low rooms
Light engine LED illumination unit with 16 individual LEDs
Power module Switching power supply located on an external mounting plate
SC Safety check
sensoGrip Multifunctional handle
sensoTouch Control panel with display as status indicator
SPS Safety power supply (mains)
SurgiCam®Camera system as SurgiCam®digital or SurgiCam®HD variant
variLUX Switches form of light field, circular/oval

Instructions for Use
Operating Lights marLED®V10/V16
V. 1.3 7
1Product Liability and Warranty
1.1 General Information
We thank you for having decided to buy one of our products. This product carries the CE mark,
which means that it satisfies the essential requirements laid down in the EC Directive
concerning medical devices.
We are the manufacturer of this product:
Gebrüder Martin GmbH & Co. KG
A company of the KLS Martin Group
KLS Martin Platz 1 · D-78532 Tuttlingen · Germany
Postfach 60 · D-78501 Tuttlingen · Germany
Tel. [phone] · Fax [phone]
[e-mail] · www.klsmartin.com
1.2 Intended Use
These lights may only be used for the specific purpose for which they have been designed:
Illumination of a surgical or examination field by surgeons, physicians and
adequately trained assistant personnel
These operating lights may only be operated in medical-use rooms whose electrical installation
complies with DIN/VDE 0100 Part 710 requirements (the German standard in force since
Nov. 1, 2002) or with the corresponding local regulations of the country in which they are
used!
WARNING
D
anger of injury by electric shock!
To prevent any risk of electric shock, be sure to connect the lights only to power supply
systems providing protective grounding.
WARNING
Risk o
f injury due to unauthorized modification of the product!
Altering the product in any way can pose a life hazard due to electric shock caused by a
defect in the light. Moreover, it can lead to injury if the light crashes down or the spring arm
snaps up vio
lently in response to high spring forces! Therefore, unauthorized modifications
are strictly forbidden under any circumstances.

Instructions for Use
Operating Lights marLED®V10/V16
8 V. 1.3
NOTICE
Risk of interference and malfunction
•
As a medical electrical device, the operating light is subject to special precautions
regarding electromagnetic compatibility (EMC). It is mandatory to install and operate the
device in accordance with the EMC Guidelines provided herein, see section 15 “Guidelines
and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC)”, page 38.
•
Operating RF devices near the operating light may degrade the performance of the
operating light. For separation distances to be observed, see section 15 “Guidelines and
Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC)”, page 38.
•
Using the operating light in conjunction with accessories other than those approved by
the manufacturer may lead to increased interference emission and reduce the immunity
of the operating light.
•
The operating light should not be placed next to or onto other devices. If close proximity
to other devices cannot be avoided, be sure to verify the functional reliability of the
operating light before using the operating light in such setup.
The operator may operate the device only if an on-site functional test has previously been
performed by Gebrüder Martin or a person authorized by Gebrüder Martin. In addition, a
responsible person designated by the operator must have been instructed in the proper
handling, application and operation of the device, as well as in its permissible combination with
other medical devices, objects and accessories. This duly instructed officer shall subsequently
be responsible for familiarizing the operator’s staff with the device as the need arises.
We recommend documenting all user instructions in a medical device logbook. A copy of the
logbook is available from Gebrüder Martin.
The operational safety of the device must be verified at regular intervals, see section 10
“Maintenance”, page 32 and section 14 “Safety Checks (SC)”, page 37.
If the device is not functionally reliable and/or safe to operate, it must be marked as such and
withdrawn from service. A technical check is mandatory in any such case.

Instructions for Use
Operating Lights marLED®V10/V16
V. 1.3 9
1.3 Warranty
Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements di-
verging from these Standard Terms and Conditions do not restrict the legal rights of the buyer.
Any warranty exceeding the above provisions shall require a contractual form and shall exclude
component-related vandalism, software updates and consumables.
Important Notices
The product may only be repaired by Gebrüder Martin or a qualified person or firm expressly
authorized by Gebrüder Martin to perform such work.
If the repair is carried out by a person or firm specially authorized by Gebrüder Martin, the
operator of the product is required to obtain from the repairer a certificate with details about
the nature and scope of the repair work done. This certificate must show the date of the repair
and the details of the person or firm carrying out the work and must be signed.
In all cases where a party other than the product manufacturer performed the work, repaired
products must be additionally marked with the repairer’s ID label.
Improper interventions or alterations performed by third parties during the period of limitation
shall void any and all warranty claims. Unauthorized actions performed on the product shall
invalidate any liability claims against Gebrüder Martin.
1.4 User’s Inspection
•Immediately upon receipt, the goods must be checked for completeness and potential
damage in transit.
•Notice of any such damage must be given immediately.

Instructions for Use
Operating Lights marLED®V10/V16
10 V. 1.3
1.5 Hotline
•Should you have any questions on how to handle the product or use it for clinical
applications, please do not hesitate to contact the Product Management:
Tel: [phone]
Fax: [phone]
•Should you have any technical questions, please do not hesitate to turn to our
Martin Service Center:
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
•Should you have any questions concerning maintenance contracts or training courses,
please contact our Technical Service Manager:
Tel: [phone]
E-mail: [e-mail]
NOTICE
To answer
your technical questions as efficiently as possible, our service technicians require
the serial number of the product. Therefore, please have this number at hand when
contacting our hotline. It is part of the information provided on the rating plate;
see section 13 “Serial Number Structure”, page 36.
2Notices Concerning this Document
Non
-observance of this document can lead to serious or even lethal patient injury!
Improper handling and care as well as non
-intended use can lead to premature wear and/or
pose a risk to patients and users!
It is the operator's responsibility to ensure that all personn
el handling the product have
understood and do observe the notes and instructions in this document.
•Every user is required to read this document completely and follow it carefully.
•In particular, be sure to heed all cautions, warnings and danger notices.
•Keep this document accessible to users at all times.

Instructions for Use
Operating Lights marLED®V10/V16
V. 1.3 11
2.1 Validity of this Document
This document is valid from software release SW 14 and hardware release HW 21. If used with
older hardware releases, it may be that newer functions described in this document are not
available.
2.2 Symbols Used in this Document
Throughout this document, important information (such as general or safety-related notices) is
marked with the following symbols and signal words:
WARNING
Danger to life or danger of serious injury!
Indicates a situation which, if not avoided,
could result in death or serious injury!
CAUTION
Danger of injury!
Indicates a situation which, if not avoided, could result in minor or moderate injury!
NOTICE
Risk of material damage!
Indicates a
situation which, if not avoided, could lead to material damage (loss of time, data
loss, device/machine failure, etc.)!

Instructions for Use
Operating Lights marLED®V10/V16
12 V. 1.3
3Safety Notices
3.1 General Information
The operating lights are quality products designed and manufactured in accordance with the
recognized technical rules. The products leave the factory in a perfectly safe working condition.
To maintain this status, you – as the end user – are required to abstain from or prevent any
action that might have an adverse effect on the lights’ safety characteristics.
•Observe the following safety notices!
•Be sure to follow all instructions provided in this document!
Should the light or any of its components become damaged or defective:
•Disconnect the light from the power supply!
•Safeguard the light or its components against dangerous contact with persons! Place
warning signs where appropriate.
•Contact the manufacturer or service technician at once!
Upon completion of any repair or service work, it is mandatory for the service technician to
check all functions of the light, the tracking and spring arms and the power supply units, thus
ensuring their proper working order and operational safety!
NOTICE
It is not permitted to attach to or inst
all on the operating lights any components or systems
other than accessories that have been expressly approved by Gebrüder
Martin.

Instructions for Use
Operating Lights marLED®V10/V16
V. 1.3 13
3.2 Pilot Laser (Option)
The built-in pilot laser is a Class 2 laser according to the German DIN/VDE 0837 standard
(corresponds to EN 60825 and lEC 60825). These regulations, together with local accident
prevention regulations (VBG 93 for Germany), must be duly observed when operating the
laser.
NOTICE
D
ue to the eyelid closure reflex, the pilot laser radiation is harmless for non-narcotized
persons.
As long as the impact of the laser radiation is accidental and limited to a maximum period of
0.25 s, Class-2 laser equipment does not pose a danger to the human eye.
Therefore, Class-2 laser equipment may be used without any special protective measures,
provided that the application requires neither deliberate eye contact for more than 0.25 s nor
repeated eye contact with the direct or reflected laser radiation.
As the eye-protecting lid closure reflex cannot usually be taken for granted, we recommend
closing the eyes deliberately and turning away from the light source immediately if Class-2
laser radiation hits the eye.
WARNING
Eye injury hazard for anesthetized persons!
In the case of anesthetized persons, measures must be taken to prevent the laser radiation
from hitting the open eye for more than 0.25
s. For example, cover the patient’s eyes with a
towel!
“Laser radiation” warning labels
•These warning signs are attached to the sterilizable
handle and next to the control panel. The laser beam’s
exit opening (aperture) is located inside the central
handle.
•Operating the sterile handle activates the pilot laser,
which is automatically deactivated after
approx. 5 seconds.
It is the user’s own responsibility to observe and implement the above provisions/regulations.

Instructions for Use
Operating Lights marLED®V10/V16
14 V. 1.3
3.3 Personal Protection
WARNING
Danger of serious injury from defective lights!
Defective lights can damage the health or even threaten the lives of users and
/or patients!
•
Therefore, never operate defective lights!
WARNING
Danger of serious injury from excessive heat development!
When using several lights in combination, the light fields should not overlap when using
maximum illuminance and very sm
all light field diameters. Non-compliance could pose a
hazard of excessive heat gener
ation in the light field (>1,000 W/m²)!
WARNING
Danger of explosion!
The operating light may b
e used only at a safe distance from openings or surfaces emitting or
releasing anesthetic gases, oxygen or other flammable or oxidizing gases.

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Operating Lights marLED®V10/V16
V. 1.3 15
3.4 Operation
•Prior to each use, be sure to check the lights for safe functioning and proper operating
condition!
•Be sure to handle the lights in accordance with the instructions provided in this user
manual (including putting them into and out of operation)!
WARNING
Danger of serious injury in
the event of light failure!
When working with a single operating light, there will be a residual risk of functional failure in
spite of the additional safety power supply. Therefore, it is the surgeon’s responsibility to
decide whether the intended interv
ention can be carried out under such circumstances or not.
NOTICE
Risk of damage to light!
•
Protect the light from mechanical impact during operation, such as may be caused by arm
movements when inserting a hip prosthesis or pulling off components. As such
movements are typically performed with edged or sharp instruments, there is a potential
danger of damaging the bottom glass pane of the operating light!
•
Avoid collision with other OR equipment (such as ceiling-mounted pendant systems or
articulated arm systems)!
•
Adjust the light head’s position with care, approaching the arm stops slowly and applying
only moderate force!
WARNING
Danger of patient eye damage!
For anesthetized patients, there is a danger of eyesight overstrain or permanent eyesight
damage due to suspended eyelid closure reflex.
•
Do not direct the light towards the eyes of the patient where avoidable.
•
If necessary, cover the patient’s eyes.

Instructions for Use
Operating Lights marLED®V10/V16
16 V. 1.3
3.5 Cleaning and Infection Protection
•In addition to the following safety notices, observe the cleaning and disinfection
instructions provided in section 9 “Cleaning and Disinfecting the Light”, page 27.
WARNING
Danger of serious injury from electric shock!
Prior to performing any cleaning or disinfecti
ng work, be sure to deenergize the light system:
•
Disconnect the light system all-pole from the power supply.
•
Secure it against reconnection.
•
Protect light system from splash water; do not use wet cleaning/disinfection.
•Never insert any objects into the openings of the units!
WARNING
Danger of infection from non
-sterile handling!
•
To protect yourself against infection, maintenance or service work should only be
performed after the lights and associated equipment have been adequately cleaned and
disinfected where appropriate!
•
Clean only cold lights! This avoids potential hazards due to disinfectant or cleaning agent
evaporation and a consequential ineffectiveness of the disinfection because the
disinfectant would not have enough time to take effect.
NOTICE
Risk of damage to light!
When using the
“wiping” technique as permitted by Gebrüder Martin for surface disinfection,
apply just enough disinfecting liquid to pr
event the formation of “pools” and the consequential
capillary action through which the liquid could be drawn into the light head.

Instructions for Use
Operating Lights marLED®V10/V16
V. 1.3 17
4Light Models and Combination Options
4.1 Light Models
The lights are available in the following variants:
•Size of light head:
—marLED®V10 (max. illuminance of 130,000 lx): 64 x 46 cm
—marLED®V16 (max. illuminance of 160,000 lx): 87 x 64 cm
•Options:
—pilot laser
—SurgiCam®camera system (this product comes with its own user manual)
—backLite on tracking arm provides diffuse, indirect background light at the end of the
respective tracking arm, emitted in an upward direction. The light is automatically
switched on and off through a photoelectric sensor.
For switching threshold details, see marLED®Mounting Instructions.
—wall operation (wall-mounting control panel)
—RS232 Com interface for integrated OR systems
—additional safety power supply (ASPS)
—LC (Low Ceiling) cardanic suspension for low rooms
•Available mounting/installation options:
—ceiling-mounting: single lights, light combinations
—wall-mounting (marLED®V10) with separate power supply on external mounting plate
—mobile version (stand version): marLED®V10
4.2 Light Combinations
The lights can be mounted either individually (as single lights) or in combinations of two, three
or four lights (optionally in conjunction with TFT monitor or separate camera). Each light is
controlled via a separate sensoTouch control panel.

Instructions for Use
Operating Lights marLED®V10/V16
18 V. 1.3
5Description of the Lights
5.1 LED Technology
The marLED®V10/V16 lights operate on the basis of LED illumination units (so-called “light
engines”) of the latest technology. Compared with conventional halogen lamps, these
“engines” offer significantly more flexibility regarding several basic lighting parameters.
Besides, the generated light has no infrared content at all. As the lights do not contain any
moving parts either, they are completely maintenance-free.
5.2 Starting Performance
The marLED®V10/V16 operating lights are “intelligent” lights. They are automatically set to
a medium light field diameter and an illuminance of 75% during startup. Other startup
parameters can be set as well upon request (such as the initial operating state after turning on
the light via the mains switch, illumination intensity, color temperature, type and/or size of
light field).
Immediately upon switching them on, the software version and the accumulated operating
hours (10-hour units) are briefly displayed at the color temperature position (5, Fig. 6-1,
page 21). Example:

stands for 780 hours.
If the “wall-mounted control panel” option has been implemented, indication of the software
version is followed by indication of the communication status of the external interface
(e.g. OR1):

=no connection,

=connection OK.
5.3 Options
5.3.1 Additional Safety Power Supply (ASPS)
All lights can be optionally equipped with an ASPS changeover assembly, which can either be
integrated into the ceiling tube or installed separately. Where the light has an external power
supply located in a switchbox, the ASPS is installed on the same mounting plate as the power
module.
A dual LED – which can be optionally installed in the canopy or on the mounting plate –
indicates the type of power supply currently used:
Green LED
Red LED
Safety power supply (SPS/mains)
Additional safety power supply (ASPS/battery)

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Operating Lights marLED®V10/V16
V. 1.3 19
5.3.2 Cameras SurgiCam® digital, SurgiCam® HD
The SurgiCam® digital and SurgiCam® HD systems are imaging systems for documentation
and/or training purposes. Each of these high-performance camera systems can either be
integrated into the light head’s central handle or installed on an arm of its own. All
Gebrüder Martin camera systems come with a separate user manual. For image display, the
optional Gebrüder Martin med TFTpro flat-screen monitor is used.
5.3.3 Gebrüder Martin Pilot Laser
WARNING
Eye injury hazard for anesthetized persons!
In the case of anesthetized persons, measures must be taken to preven
t the laser radiation
from hitting the open eye for more than 0.25
s. For example, cover the patient’s eyes with a
towel!
The pilot laser integrated into the operating light marks
exactly the center of the light field. This makes it very easy
to focus the light field on small surgical sites.
Operating the sterile handle activates the pilot laser for
approx. 5 s. It is automatically switched off thereafter.

Instructions for Use
Operating Lights marLED®V10/V16
20 V. 1.3
6Operating the Lights
The lights can be operated in two different ways: non-sterile via the sensoTouch control panel,
or sterile via the sensoGrip integrated into the handle.
6.1 Mounting the Sterilizable Handle
Prior to each operation, the light must be fitted with the sterilized handle (see section 7.1
“Replacing the Sterilizable Handle”, page 24).
WARNING
Danger of infection in the ev
ent of non-sterile handling!
Gebrüder
Martin’s exchangeable handles are delivered non-sterile. Therefore, they must be
sterilized prior to their first sterile use,
see section 9.4 “Machine Disinfection and Sterilization
of the Handles
”, page 30.
Improper sterilization and non
-sterile handling of the handles can pose serious health hazards
to patients.
The responsibility for handle cleaning, disinfection and sterilization lie
s with the
operator/product user.
Approved sterilization packaging (e.g. conforming to EN
868, ISO 11607) must be used for
sterilization, subsequent transportation and storage of the handles.
Be sure to observe all relevant national/local regulations as we
ll.
6.2 Operation via the sensoTouch Control Panel
All functions of the marLED®lights are clearly displayed via the sensoTouch control panel (1)
installed on the cardan joint of the suspension system and can be conveniently controlled in
this way.
The control buttons for the various functions are marked with symbols for easy orientation.
They are sensor keys which you just need to touch lightly with your fingertip (no action point).
Touching them briefly triggers an acoustic confirmation signal and the button function is
immediately executed.