Hillrom Trumpf Medical iLED 7 User manual

Instruction Manual
iLED® 7 Lighting system
Read the instruction manual carefully before using the product and keep it safe for future refer-
ence.
ENGLISH
en-US

55000-00004_030_01 – 2070134 – 2018-01-04 3
Thank you very much
for purchasing the new iLED® 7 lighting system. Please read through this
instruction manual carefully and ensure adherence to all safety instructions
and requirements regarding the operation and care of the device.
This instruction manual is valid for the following components:
iLED® 7 lighting systems:
• Designed as a single surgical light with a lamp head in ceiling-mounted or
mobile version
• Designed as a surgical lighting system with a combination of two to three
surgical lights in ceiling-mounted version
Control system for the iLED® 7 lighting system:
• External control units Control and WallControl Panel
• TruRemote operating software
The operation of the optional camera system is described in the following
instruction manual:
• TruVidia® Wireless camera system and VidiaPort TFT support arm system

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How to contact us
Manufacturer and distributor TRUMPF Medizin Systeme GmbH + Co. KG
Carl-Zeiss-Straße 7-9
07318 Saalfeld
Germany
[e-mail]
www.trumpfmedical.com
Below, Trumpf Medical is used as a synonym for TRUMPF Medizin Systeme
GmbH + Co. KG in order to facilitate easier reading.
Technical Customer Service The contact details for the current Technical Customer Service hubs in the
individual countries can be found on the Internet at
www.trumpfmedical.com.
Technical customer service is used as a synonym for Trumpf Medical
Customer service and for technicians authorized by Trumpf Medical and
trained service providers.
Phone: [phone]
Fax: [phone]

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Information about the document
Original instruction manual for the iLED® 7 lighting system
This information can be found in the footer of each page and is binding for the
validity of the instruction manual. It must not be removed, regardless of the
type of publication (in printed form, electronic form or excerpt form).
Document number: 55000-00004_030_01
Material number: 2070134
Date of publication: 01/04/2018

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Validity
Supporting documents
Designation Document number Material no.
TruVidia® Wireless camera
system instruction manual DE
55000-00030 2022461
RH interface converter
iLED® 7 DE / EN
55000-00029 2068523
EPC iLED® 7 DE / EN 55000-00038 2025701
SM iLED® 7 DE 55000-00006 2015531
IA iLED® 7 DE 55000-00005 1971385
VidiaPort holder Duo
instruction manual
55000-00033 1836570
VidiaPort holder Single
instruction manual
55000-00033 1836569

Validity
55000-00004_030_01 – 2070134 – 2018-01-04 7
Designator / rating Type Item No.
This document applies to the following sales units:
iLED® 7
For the position of the serial numbers, see
Chapter 5.1.
iLED® 7 single 4068110
iLED® 7 / mobile iLED® 7 mobile [phone]
iLED® 7 / iLED® 7
iLED® 7 / VidiaPort 2000
iLED® 7 / VidiaPort 3000
iLED® 7 / VidiaPort 5000
VidiaPort 2000 / iLED® 7
VidiaPort 3000 / iLED® 7
VidiaPort 5000 / iLED® 7
iLED® 7 duo 4068210
iLED® 7 / iLED® 7 / iLED® 7
VidiaPort 2000 / iLED® 7 / iLED® 7
VidiaPort 3000 / iLED® 7 / iLED® 7
VidiaPort 5000 / iLED® 7 / iLED® 7
iLED® 7 / iLED® 7 / VidiaPort 2000
iLED® 7 / iLED® 7 / VidiaPort 3000
iLED® 7 / iLED® 7 / VidiaPort 5000
VidiaPort 2000 / iLED® 7 / VidiaPort 2000
VidiaPort 2000 / iLED® 7 / VidiaPort 3000
VidiaPort 2000 / iLED® 7 / VidiaPort 5000
VidiaPort 3000 / iLED® 7 / VidiaPort 2000
VidiaPort 3000 / iLED® 7 / VidiaPort 3000
VidiaPort 3000 / iLED® 7 / VidiaPort 5000
VidiaPort 5000 / iLED® 7 / VidiaPort 2000
VidiaPort 5000 / iLED® 7 / VidiaPort 3000
VidiaPort 5000 / iLED® 7 / VidiaPort 5000
iLED® 7 / iLED® 7 / iLED® 7 / VidiaPort 2000
iLED® 7 / iLED® 7 / iLED® 7 / VidiaPort 3000
iLED® 7 / iLED® 7 / iLED® 7 / VidiaPort 5000
VidiaPort 2000 / iLED® 7 / iLED® 7 / iLED® 7
VidiaPort 3000 / iLED® 7 / iLED® 7 / iLED® 7
VidiaPort 5000 / iLED® 7 / iLED® 7 / iLED® 7
VidiaPort 2000 / iLED® 7 / iLED® 7 / VidiaPort 2000
VidiaPort 2000 / iLED® 7 / iLED® 7 / VidiaPort 3000
VidiaPort 2000 / iLED® 7 / iLED® 7 / VidiaPort 5000
VidiaPort 3000 / iLED® 7 / iLED® 7 / VidiaPort 2000
VidiaPort 3000 / iLED® 7 / iLED® 7 / VidiaPort 3000
VidiaPort 3000 / iLED®
7 / iLED® 7 / VidiaPort 5000
VidiaPort 5000 / iLED® 7 / iLED® 7 / VidiaPort 2000
VidiaPort 5000 / iLED® 7 / iLED® 7 / VidiaPort 3000
VidiaPort 5000 / iLED® 7 / iLED® 7 / VidiaPort 5000
iLED® 7 trio / quad 4068310

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Information regarding this document
Original instruction manual
on CD
This instruction manual can be found in PDF form on the CD enclosed with the
system from Trumpf Medical. Please contact Trumpf Medical Customer
Service if you need to request a replacement CD.
Keep the instruction manual with
the system
For reference purposes, a printout of this instruction manual must be kept in
an easily accessible location, near the system.
Notes on copyright and property rights
Copyright All rights reserved. These instruction manual are protected by copyright law.
• Any other use than that regulated by law must be approved in writing by
TRUMPF Medizin Systeme GmbH + Co. KG.
• TRUMPF Medizin Systeme GmbH + Co. KG accepts no liability for any
damage arising from the non-permitted use of the information set out in
these instructions by other persons or companies.
iLED® is a registered trademark of TRUMPF Medizin Systeme GmbH + Co. KG.
TruVidia® is a registered trademark of TRUMPF Medizin Systeme GmbH + Co.
KG.
Modifications and translations
Modifications to the device Since our products are subject to continuous further development, we
reserve the right to modify the form, equipment and technology of our scope
of delivery.
Modifications to the instruction
manual
• The content of this instruction manual is subject to change without prior
notice.
• The German instruction manual is the original instruction manual.
Translations • The German language version of this instruction manual shall be binding
with respect to translations into foreign languages.

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Table of contents
1 Safety instructions ..................................................................................................... 14
1.1 Structure of the safety information in this instruction manual ......................................................................14
1.1.1 Identification of physical harm .......................................................................................................................................... 14
1.1.2 Warnings of damage to property....................................................................................................................................... 14
1.1.3 Identification of additional information ............................................................................................................................14
1.2 Graphic symbols used in the safety instructions ............................................................................................15
1.3 Graphic symbols on the device .......................................................................................................................15
1.3.1 General notes.....................................................................................................................................................................15
1.3.2 Radio identification............................................................................................................................................................16
1.4 Pictograms on the packaging ..........................................................................................................................18
1.5 Overview of the most important safety instructions......................................................................................19
2 Important information for safe use............................................................................. 27
2.1 Groups of individuals ......................................................................................................................................27
2.1.1 Operators...........................................................................................................................................................................27
2.1.2 Users ..................................................................................................................................................................................27
2.1.3 Qualified staff.....................................................................................................................................................................27
2.2 Information for operators...............................................................................................................................27
2.2.1 Initial commissioning .........................................................................................................................................................27
2.2.2 Availability of the instruction manual................................................................................................................................28
2.2.3 Disclaimer of liability..........................................................................................................................................................28
2.2.4 Maintenance and Repair....................................................................................................................................................28
2.2.5 Service life of all components in the iLED® 7 lighting system............................................................................................ 29
2.2.6 Date of production.............................................................................................................................................................29
2.3 Delivery ...........................................................................................................................................................29
2.3.1 Damage in transit...............................................................................................................................................................29
2.3.2 Address for returns ............................................................................................................................................................29
2.4 Notes for users................................................................................................................................................29
2.4.1 Training on the device........................................................................................................................................................30
2.4.2 Information and inspection commitment of the user ....................................................................................................... 30
2.5 Compliance .....................................................................................................................................................30
2.5.1 Marking..............................................................................................................................................................................30
2.5.2 Standards and directives....................................................................................................................................................30
2.5.3 Internationally applied standards......................................................................................................................................31
2.5.4 Proper use..........................................................................................................................................................................31
2.5.5 Improper use......................................................................................................................................................................32
2.5.6 Application.........................................................................................................................................................................32
2.5.7 Special conditions ..............................................................................................................................................................33
2.6 Ambient conditions for operation and storage...............................................................................................34
2.6.1 Ambient conditions for operation .....................................................................................................................................34
2.6.2 Ambient conditions for storage .........................................................................................................................................34
2.7 Combination with other medical devices .......................................................................................................34
2.8 Combination with non-medical devices..........................................................................................................34
2.9 Disposal...........................................................................................................................................................35
3 The technology of the lighting system......................................................................... 36
3.1 The lamp head ................................................................................................................................................36
3.2 The LED illuminant ..........................................................................................................................................37
4 Overview of abbreviations and terms ......................................................................... 38
5 Identification of the lighting system ........................................................................... 39
5.1 Use of serial numbers .....................................................................................................................................39

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5.1.1 Position of the serial numbers on the ceiling-mounted version........................................................................................39
5.1.2 Position of the serial numbers on the mobile pedestal version ........................................................................................41
5.1.3 Position of the sensor detection (laser).............................................................................................................................41
5.1.4 Position of the serial numbers on the Control...................................................................................................................42
5.1.5 Position of the serial numbers on the WallControl Panel.................................................................................................. 42
5.1.6 Position of the serial numbers on the Dock desk ..............................................................................................................42
5.2 Scope of delivery iLED® 7 ................................................................................................................................42
6 Description of the device and its functions.................................................................. 43
6.1 Components of the iLED® 7 lighting system ...................................................................................................43
6.1.1 Hardware ...........................................................................................................................................................................43
6.1.2 TruRemote operating software .........................................................................................................................................44
6.2 Ceiling-mounted version.................................................................................................................................45
6.2.1 Ceiling-mounted version designs.......................................................................................................................................45
6.2.2 Components of the ceiling-mounted version .................................................................................................................... 45
6.2.3 Optional camera on the lamp head ................................................................................................................................... 45
6.2.4 Rotational / swivel range of the ceiling-mounted version.................................................................................................46
6.3 Mobile pedestal version..................................................................................................................................48
6.3.1 Designs of the mobile pedestal version.............................................................................................................................48
6.3.2 Components of the mobile pedestal version..................................................................................................................... 48
6.3.3 Power supply to the mobile pedestal version ................................................................................................................... 48
6.3.4 Rotational / swivel movements of the mobile pedestal version ....................................................................................... 49
6.4 Non-sterile positioning of the lamp head .......................................................................................................50
6.5 Sterile positioning of the lamp head...............................................................................................................50
6.6 Non-sterile operation on the operating element ...........................................................................................50
6.6.1 States of the operating element ........................................................................................................................................ 51
6.7 Non-sterile operation with TruRemote operating software...........................................................................51
6.8 Control sequence ............................................................................................................................................52
6.9 Sterile operation with the hand grip...............................................................................................................52
6.9.1 Sterile Light Control (SLC), optional use............................................................................................................................. 52
7 Commissioning .......................................................................................................... 54
7.1 Checking the lighting system ..........................................................................................................................54
7.2 Positioning the lighting system .......................................................................................................................55
7.2.1 Risk of collision while positioning ......................................................................................................................................56
7.2.2 Positioning the ceiling-mounted version ........................................................................................................................... 56
7.2.3 Taking the ceiling-mounted version out of service............................................................................................................ 57
7.3 Commissioning the mobile pedestal version ..................................................................................................57
7.3.1 Positioning the mobile pedestal version............................................................................................................................57
7.3.2 Positioning the pedestal ....................................................................................................................................................58
7.3.3 Connecting the mobile pedestal version to the mains power supply................................................................................59
7.3.4 Taking the mobile pedestal version out of service ............................................................................................................ 60
7.4 Dock desk ........................................................................................................................................................61
7.4.1 Selecting the location of the Dock desk.............................................................................................................................61
7.4.2 Connecting the Dock desk to the power supply ................................................................................................................ 61
7.4.3 Replacing the Dock desk power pack.................................................................................................................................62
7.5 Control / WallControl Panel............................................................................................................................63
7.5.1 Removing bumpers / putting bumpers on the Control ..................................................................................................... 63
7.5.2 Charging the Control..........................................................................................................................................................64
7.5.3 Switching the Control On / Off...........................................................................................................................................64
7.6 Inspections ......................................................................................................................................................65
7.6.1 Before commissioning ....................................................................................................................................................... 65
7.7 Handing over of the organization system .......................................................................................................66

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8 Daily use of the surgical lighting system...................................................................... 67
8.1 Introduction ....................................................................................................................................................67
8.2 Work rules.......................................................................................................................................................67
8.3 Prescribed steps..............................................................................................................................................67
8.4 User-specific configuration .............................................................................................................................70
8.4.1 Coupling the grip adapter / camera................................................................................................................................... 70
8.4.2 Decoupling the grip adapter / camera...............................................................................................................................72
8.4.3 Fitting the sterile hand grip (camera / grip adapter) ......................................................................................................... 73
8.4.4 Removing the sterile hand grip (camera / grip adapter) ................................................................................................... 73
9 Operating the OR light directly on the operating element ............................................ 74
9.1 Switching the lamp head on / off....................................................................................................................74
9.1.1 Putting the power supply in standby mode....................................................................................................................... 74
9.1.2 Switching on the lamp head ..............................................................................................................................................74
9.1.3 Switching the lamp head off .............................................................................................................................................. 74
9.1.4 Disconnecting the lighting system ..................................................................................................................................... 75
9.2 Adjusting the lighting intensity .......................................................................................................................75
9.3 Activating and deactivating the radio connection / safe mode......................................................................76
9.3.1 Adjusting the lighting intensity in a sterile manner with the Sterile Light Control (SLC)................................................... 77
9.4 Light functions.................................................................................................................................................77
9.4.1 Adaptive Light Control plus (ALC plus)...............................................................................................................................77
9.4.2 Diameter of the field of illumination ................................................................................................................................. 77
9.4.3 Shadow management ........................................................................................................................................................77
9.4.4 Setting the color temperature ...........................................................................................................................................77
9.4.5 Lamp head synchronization (Sync) ....................................................................................................................................78
10 Operating the OR light with the TruRemote operating software ................................... 79
10.1 Introduction ....................................................................................................................................................79
10.1.1 Conditions for operation....................................................................................................................................................79
10.2 Operating the Control / WallControl Panel.....................................................................................................80
10.2.1 Unlocking the Control / WallControl Panel........................................................................................................................80
10.2.2 Energy-saving mode...........................................................................................................................................................80
10.2.3 Operating safety ................................................................................................................................................................80
10.3 Adjusting the settings (hospital technicians only) ..........................................................................................81
10.3.1 Opening the settings screen .............................................................................................................................................. 81
10.3.2 Changing the room name ..................................................................................................................................................81
10.3.3 Defining the scope of synchronization...............................................................................................................................81
10.3.4 Enabling / disabling the one click screen ...........................................................................................................................82
10.3.5 Calling the control screens from a settings screen ............................................................................................................ 82
10.4 Structure of the TruRemote operating software ............................................................................................83
10.4.1 Graphical user interface of the iLED® 7 surgical light ........................................................................................................ 83
10.4.2 Screen structure - all screen types.....................................................................................................................................84
10.4.3 Screen structure - control screen.......................................................................................................................................85
10.4.4 Screen structure - One-click screen ...................................................................................................................................86
10.5 Calling up other screens from a control screen ..............................................................................................87
10.5.1 Opening other control screens .......................................................................................................................................... 87
10.5.2 Opening the settings screen .............................................................................................................................................. 87
10.6 Calling the control screens from a settings screen .........................................................................................87
10.7 Operating the light..........................................................................................................................................88
10.7.1 Switching on the light ........................................................................................................................................................88
10.7.2 Switching off the light ........................................................................................................................................................ 88
10.7.3 Adjusting the light..............................................................................................................................................................90

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10.7.4 Activating shadow management .......................................................................................................................................90
10.7.5 Synchronizing all lights.......................................................................................................................................................91
10.7.6 Switching all lights on.........................................................................................................................................................91
10.7.7 Switch all lights off .............................................................................................................................................................91
10.7.8 Setting all lights to Endo lighting intensity......................................................................................................................... 91
10.7.9 Operating the one-click screen .......................................................................................................................................... 92
11 Cleaning, disinfection and sterilization........................................................................ 93
11.1 General............................................................................................................................................................93
11.2 Recommended disinfecting agents.................................................................................................................94
11.3 Cleaning and disinfection of the surgical lighting system ...............................................................................94
11.3.1 General...............................................................................................................................................................................94
11.3.2 Wipe-down disinfection.....................................................................................................................................................95
11.4 Sterilization of OR light hand grips..................................................................................................................96
11.4.1 Preparation ........................................................................................................................................................................97
11.4.2 Cleaning and disinfection...................................................................................................................................................97
11.4.3 Sterilization ........................................................................................................................................................................98
11.4.4 Sterilization packaging .......................................................................................................................................................98
11.5 Cleaning, disinfection and sterilization of external control units ...................................................................99
11.5.1 Cleaning and disinfection...................................................................................................................................................99
11.5.2 General.............................................................................................................................................................................100
11.5.3 Wipe-down disinfection...................................................................................................................................................100
11.5.4 Sterilization ......................................................................................................................................................................100
12 Inspections and maintenance ................................................................................... 101
12.1 Inspections during operation........................................................................................................................101
12.1.1 Defective or damaged devices or accessories ................................................................................................................. 101
12.2 Annual visual inspection ...............................................................................................................................102
12.3 Two-year maintenance .................................................................................................................................103
13 Adjustments ............................................................................................................ 104
13.1 Introduction ..................................................................................................................................................104
13.2 Adjusting the swivel range of the mobile pedestal version’s spring arm .....................................................104
13.2.1 Disconnect the mobile pedestal version..........................................................................................................................104
13.2.2 Adjusting the swivel range...............................................................................................................................................104
13.3 Setting the swivel ranges of the spring arm support arm system ................................................................105
13.3.1 Adjusting the swivel range...............................................................................................................................................105
13.4 Setting the spring force of the spring arm ....................................................................................................106
13.4.1 Ceiling-mounted version..................................................................................................................................................106
13.4.2 Mobile pedestal version...................................................................................................................................................106
13.5 Setting the braking force of the support arm system friction brakes...........................................................107
13.5.1 Disconnecting the lighting system ................................................................................................................................... 107
13.5.2 Setting the braking force for the extension arm.............................................................................................................. 107
13.5.3 Setting the braking force for the spring arm ................................................................................................................... 108
13.5.4 Setting the braking force for the lamp head on the comfort bracket or ¼ bracket......................................................... 109
13.6 Setting the friction brake of the spring arms (mobile pedestal version, NRH of the ceiling-mounted systems)
110
14 High-wear parts ....................................................................................................... 111
15 Troubleshooting ...................................................................................................... 112
16 Technical data ......................................................................................................... 114
16.1 Equipment of the surgical light .....................................................................................................................114

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16.2 Device data ...................................................................................................................................................114
16.3 EMC information...........................................................................................................................................117
16.3.1 iLED® 7 lighting system ....................................................................................................................................................118
16.3.2 WallControl Panel ............................................................................................................................................................124
17 List of components................................................................................................... 130
17.1 iLED® 7 components and accessories ...........................................................................................................130

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1 Safety instructions
1.1 Structure of the safety information in this instruction
manual
Important notes in this instruction manual are marked with graphic symbols
and signal words.
Signal word
Warning symbols
Pictogram
1.1.1 Identification of physical harm
DANGER refers to an immediate hazard, which, if not avoided, will lead to
death or severe injury.
WARNING refers to a potential hazard which, if not avoided, can lead to death
or severe injury.
CAUTION refers to a potential hazard, which, if not avoided, can lead to minor
or slight injury.
1.1.2 Warnings of damage to property
ATTENTION refers to a potential hazard, which, if not avoided, can lead to
damage to property.
1.1.3 Identification of additional information
NOTE provides additional information and useful tips for the safe and efficient
use of the device.
DANGER
WARNING
CAUTION
ATTENTION
NOTE
In the safety information, the signal words are
located in the title field with the color
background.
They follow a specific hierarchy and, in
conjunction with the warning symbol, indicate the
severity of the hazard or the type of information.
In safety information, the warning symbols are
located in the title field with the colored
background, to the left of the signal word.
Safety information with warning symbols
indicates a risk of personal injury.
Follow the safety information to reduce the risk of
injuries or death.
Safety instructions without warning symbols
indicate risk of material damage.
The pictograms in the safety information are
intended to clearly depict the imminent hazard.
Example: Danger of explosion
DANGER
WARNING
CAUTION
ATTENTION
NOTE

15
1Safety instructions
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1.2 Graphic symbols used in the safety instructions
Gas explosion: warns of the ignition of explosive mixtures of gases
Electric shock: warns of electric shock which can lead to severe injury or even
death
Sudden release of spring arm: warns of the risk of the spring arm suddenly
jumping up when dismantling the lamp head/flat screen
Lighting system crashing: warns of the risk of the lighting system suddenly
crashing due to additional loads
Optical radiation: warns of potential damage to the retina caused by
photobiological radiation (blue light from the LEDs)
Pinch hazard: warns of the risk of catching fingers in the device
Damage to surfaces: warns of damage to surfaces caused by improper cleaning
agents and disinfectants
1.3 Graphic symbols on the device
1.3.1 General notes
CE conformity marking: shows the device’s conformity with the guidelines of
the European Medical Device Directive (MDD)
Follow the instruction manual: refers to this instruction manual
UL mark: device tested by Underwriter Laboratories Inc. for use in the USA and
Canada. UL/cUL classification with respect to electric shock, fire and
mechanical hazards only in accordance with UL 60601-1, 1st Edition, 04-26-
2006 and, ANSI/AAMI ES60601-1: 2005/(R) 2012 and CAN/CSA-C22.2 No.
60601-1: 2008
HF transmitter: the ME device contains a HF (high-frequency) transmitter
emitting non-ionizing radiation
Refers to the need for the user to consult the instruction manual for
important safety-related information such as warnings and precautionary
measures which, for a variety of reasons, cannot be attached to the medical
product itself.
Assembly / dismantling of the safety ring: To be performed only by Technical
Customer Service. The more detailed instructions relating to the assembly /
dismantling of a safety ring must be complied with.
ca. mm8
1 x
1. 2.
!
!
3.
2 x KLICK!

16
1Safety instructions
55000-00004_030_01 – 2070134 – 2018-01-04
IP40 IP code: Protection class of the lamp head through the housing according to
EN 60529:1991+A1:2000+A2:2013
First digit "4" = protected against solid foreign bodies with a diameter of 1.0
mm and greater
Second digit "0" = no protection against water
Sensor identification: Designates the class of the installed laser product for
distance measurement according to IEC 60825-1, Edition 2.0 (2007-03) and
IEC 60825-1, Edition 3 (2014).
1.3.2 Radio identification
European Union
The Trumpf Medical Wi-fi module, the Control and the WallControl Panel
comply, based on proper use, with the fundamental requirements and other
relevant provisions of Directive 2014/53/EU regarding radio systems. The
declaration of compliance can be requested using the contact details below.
The device is assigned to class B. It can cause interference in residential
buildings. The user must take appropriate measures accordingly.
National restrictions
This device is suitable for use without restriction in homes and offices in all EU
countries (and in other countries in which EU Directive 2014/53/EU applies).
Exceptions:
Country Restriction Reason / comment
Bulgaria None For outdoor operation and for
public purposes, a permit is
generally required.
France Outdoor operation is
limited to 10 mW EIRP
in the frequency range
from 2454 -
2483.5 MHz military
radio-location.
The 2.4 GHz band was
redivided a few years ago in
order to allow the relaxed
regulation currently in place.
Complete implementation
occurred in 2012.
Italy None For operation outside
proprietary premises, a
permit is generally required.
Luxembourg None For mains feed and the
provision of the service, a
permit is generally required
(not for the bandwidth).
Norway Restriction must be
complied with.
This sub-section does not
apply to the geographical
area in a radius of 20 km from
the center of Ny-Ålesund.
Russian
Federation
None May only be used in buildings.

17
1Safety instructions
55000-00004_030_01 – 2070134 – 2018-01-04
USA
FCC ID Trumpf Medical Wi-fi module: XF6-RS9113DB
FCC ID interface converter: N6C-SDMAN
This device has been tested and complies with the thresholds for digital
devices of class B according to Part 15 of the FCC provisions. These thresholds
are intended to ensure adequate protection from interference with domestic
use. The device generates and uses high-frequency radiation and may
possibly emit high-frequency radiation. If the device is not installed and
operated exactly in accordance with the instructions, radio interference may
occur. It cannot be guaranteed, however, that no interference will occur with
any given installation. Switching the device off and on again will determine
whether it is the source of any interference to radio or TV reception.
To remedy the fault, the user should then carry out one or more of the
following steps:
• Realign or reposition the receiving antenna
• Increase the distance between the device and the radio or TV
• Connect the device to a socket that is not on the same circuit as the radio
or TV
• Contact the dealer or an experienced radio / TV engineer
Canada
IC ID Trumpf Medical Wi-fi module: 8407A-RS9113DB
IC ID interface converter: 4908B-SDMAN
This device complies with the FCC regulations according to Part 15 and the
license-free RSS standards from Industry Canada. Operation is subject to the
following two conditions:
(1) This device must not cause any harmful interference.
(2) This device must be able to absorb receiving interference, including
interference that may cause undesired operation.
Australia / New Zealand
In terms of electrical safety, EMC and the radio frequency spectrum, the
product complies with the regulatory requirements relating to products that
are destined for the Australian and New Zealand market.
Israel
The iLED® 7 lighting system for Israel is exclusively limited to the use of the
lower 5 GHz band (5130 –5350 MHz).
Taiwan
㦻䞱❐䶵⚗⇝┮䘖榊㽱懊⺓㊶榊㳮丰䚕戵㽤䶻◐ℛ㬬ᇬ䶻◐⥪㬬䷘㬬㠖尞⸩
1.倢⨚㆞崜巘⚗㫋󱁻⇝┮䘖⺓櫊榊㳮᧨槭倢峀♾᧨⏻⚇ᇬ⟕壮㒥∎䞷劔⧖ₜ㈦
㝔呹帙㦃櫊䘖ᇬ┯⮶┮䘖㒥帙㦃☮岼岗󱁻䔈㊶♙┮厌ᇭ
This device was approved in accordance with its type as a low-frequency
electrical device without express permission from the authorities. The
company, the business or user must not voluntarily change the frequency,
increase the output or modify the functions and characteristics of the original
design.
2. ⇝┮䘖⺓櫊榊㳮󱁻∎䞷ₜ㈦㈀檎歪咹⸘⏷♙㄁㞍⚗㽤抩≰᧷倢䤋䚍㦘㄁㞍䚍
廰㣑᧨㑘䵚☂⋫䞷᧨₵㟈⠓咂䎰㄁㞍㣑㡈㈦儋儛∎䞷ᇭ
ⓜ檔⚗㽤抩≰᧨㖖∬榊≰㽤尞⸩⇫㯼󱁻䎰偩榊抩≰ᇭ

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1Safety instructions
55000-00004_030_01 – 2070134 – 2018-01-04
⇝┮䘖⺓櫊榊㳮檗㉜♦⚗㽤抩≰㒥ぴ㯼ᇬ䱠⸇♙携䣑䞷榊㽱懊⺓㊶榊㳮岼⌨󱁻
㄁㞍ᇭ
The use of low-frequency electrical equipment must impair neither flight
safety nor legal communication. If radio interference occurs, the use of the
device must be stopped immediately and the cause of the interference
remedied before use of the device may continue.
Legal communication includes radio transmission in accordance with the
Telecommunications Act.
Low-frequency electrical equipment should be able to tolerate interference
from installations for legal communication and from electrical equipment for
industrial, commercial and medical applications.
Qatar
The iLED® 7 lighting system produced and configured for Qatar is limited in
the production facility exclusively to the use of the 2.4 GHz band (2400 –
2435 MHz).
Singapore
Complies with IMDA standards [N1312-17]
United Arab Emirates
TRA REGISTERED No: ER54166/17
Jordan
TRC/SS/2017/101
Philippines
ESD – 1714802C
Pakistan
TAC No. 9.405/2017
Japan
The mains connection cable must be used exclusively with the equipment
supplied.
1.4 Pictograms on the packaging
Keep dry: The package must be protected from moisture or high ambient
humidity and must be covered with tarpaulin when outside.
Top: The package must be transported, handled and stored such that the
arrows point upward at all times. Rolling, flipping, tilting at a severe angle or
tipping are prohibited.

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1Safety instructions
55000-00004_030_01 – 2070134 – 2018-01-04
Moisture limit: Displays the permissible moisture range for the storage or
transport of the package. The upper or lower limit must not be exceeded.
Atmospheric pressure limit: Displays the permissible atmospheric pressure
range for the storage or transport of the package. The upper or lower limit
must not be exceeded.
Permissible temperature range: Displays the permissible temperature range
for the storage or transport of the package. The upper or lower limit must not
be exceeded.
Fragile contents: The package is fragile. It should be handled with care and
must not be dropped, tied up or similar.
Non-sterile: Indicates a medical product that has not undergone a sterilization
procedure.
1.5 Overview of the most important safety instructions
Location requirements
Gas explosions due to anesthetics
The lighting system is not suitable for use in
environments containing high concentrations of
inflammable mixtures of anesthetics with oxygen or nitrous oxide.
If such high concentrations of flammable mixtures of anesthetics
with oxygen or nitrous oxide occur in the device's environment,
there is a risk of ignition under certain conditions. In accordance
with EN ISO 11197, the hazardous area includes an area between
5 cm and 25 cm from the gas leak point.
Strong magnetic fields
The support arm systems for the lighting system should not be
used near strong magnetic fields.
Application parts type BF /CF
No application parts of type BF or CF in accordance with IEC 60601-
1 should be connected directly to the lighting system's support arm
systems.
Electric shock hazard
To avoid electric shock hazard, the lighting system may
be connected only to an appropriately grounded power
supply with ground wires.
%
%
kPa
kPa
DANGER
WARNING

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1Safety instructions
55000-00004_030_01 – 2070134 – 2018-01-04
Electrostatic charge balancing
Complications due to charge balancing
To avoid complications due to electrostatic charge balancing
between metallic device parts and the patient, the user must not
touch the surgical light, the Control or the Dock desk and the
patient at the same time.
Operations in the field of vision
Damage to eyesight
In the event of operations involving the patient’s field of
vision, high lighting intensities of the surgical lights and
the blue light of the LEDs can lead to eye fatigue or even
damage to the eyes:
• Always close the patient’s eyes, cover them or protect them
with e.g. goggles.
• Do not use the iLED® 7 surgical light for operations involving
the patient’s field of vision under anesthesia with open eyes.
• Do not look directly into the light aperture.
Overlapping fields of illumination
of several lamp heads
Tissue damage to the patient
Overlapping fields of illumination of several lamp heads with high
lighting intensities can cause tissue damage. With the early onset
of tissue dehydration:
• Separate the overlapping fields of illumination of multiple
lamp heads
• Reduce the lighting intensity of the lamp heads
Eye safety
Impairment of vision
After prolonged direct visual contact with the sensor,
eyesight may be damaged:
• Do not look directly into the sensor.
• Protect the patient's eyes - the patient’s eyes must be closed or
protected.
The performance of operations or procedures other than those
specified in this instructions manual may lead to hazardous
radiation effects by the sensor.
WARNING
WARNING
WARNING
CAUTION