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.