Hillrom Trumpf Medical TruLight 5000 User manual

Instruction manual
TruLight 5000/3000 lighting system
Read the instruction manual before using the product and store for later reference.
Englisch
en-GB

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Thank you very much
for buying the new TruLight 5000/3000 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 applies to
the TruLight 5000 and TruLight 3000 lighting systems:
• Implementation as an individual, small surgical light with a light head in stand,
wall-mounted or ceiling-mounted versions.
• Implementation as surgical lighting system, including the combination of two to
three surgical lights mounted on the ceiling.
• Optional equipment, such as light head with camera or laser.
Light head
For both machine versions – TruLight 5000 and TruLight 3000 – both the large light
head (Ø 730 mm) as well as the small light head (Ø 640 mm) are available with various
adjustments for the size of the field of illumination, light intensity and colour
temperature.
Optional camera system
The operation of the optional camera system is described in the following instruction
manual:
• TruVidia SD camera system and VidiaPort TFT support arm system,
• TruVidia HD camera system and VidiaPort TFT support arm system,
• TruVidia 3D 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
www.trumpfmedical.com
Telephone: [phone]
Fax: [phone]
E-mail: inf[email protected]om
Technical Customer Service
TRUMPF Medizin Systeme GmbH + Co. KG
Carl–Zeiss–Straße 7–9
07318 Saalfeld
Germany
Telephone: [phone]
Fax: [phone]
Email: [e-mail]

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Notes relating to this documentation
Copyright and property rights
Copyright All rights reserved. This instruction manual is protected by copyright.
• Any use not currently regulated by law must be approved in writing by
TRUMPF Medizin Systeme GmbH + Co. KG, hereinafter referred to as
Trumpf Medical.
• Trumpf Medical will assume no liability whatsoever arising from or connected
with the use of unapproved information by any person or company.
Modifications and translations
Modifications to the device We constantly work on the further development of our products and reserve the
right to make changes to the scope of delivery in terms of form, equipment and
technology.
Changes to the instruction manual • The content of the instruction manual can be changed at any time without prior
notice.
• Please keep up to date on the current version of the instructions, e.g. using the
TRUMPF Medical Online Information System (OIS) at regular intervals.
Translations • The German-language version of this instruction manual shall be binding as
regards translations into foreign languages.

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Table of Content
1 Important information regarding safe use................................................................... 10
1.1 Details for the identification of the system ....................................................................................................10
1.2 Details for identification of the instruction manual........................................................................................10
1.3 Designation of groups of individuals...............................................................................................................10
1.3.1 Operator .............................................................................................................................................................................10
1.3.2 User.....................................................................................................................................................................................10
1.3.3 Specialist personnel............................................................................................................................................................10
1.4 Information for operators...............................................................................................................................10
1.4.1 Initial commissioning ..........................................................................................................................................................11
1.4.2 Availability of the instruction manual.................................................................................................................................11
1.4.3 Guarantee...........................................................................................................................................................................11
1.4.4 Maintenance and repair .....................................................................................................................................................11
1.4.5 Service life of the device.....................................................................................................................................................11
1.5 Date of manufacture.......................................................................................................................................11
1.6 Delivery ...........................................................................................................................................................12
1.6.1 Transportation damage ......................................................................................................................................................12
1.6.2 Return address....................................................................................................................................................................12
1.7 Information for users ......................................................................................................................................12
1.7.1 Training for use of the device .............................................................................................................................................12
1.7.2 Obligation of the user to inform and to inspect .................................................................................................................12
1.8 Purpose of the device .....................................................................................................................................12
1.8.1 Identification.......................................................................................................................................................................12
1.8.2 Standards and Directives ....................................................................................................................................................13
1.8.3 Internationally applied standards.......................................................................................................................................13
1.8.4 Intended use.......................................................................................................................................................................13
1.8.5 Special features...................................................................................................................................................................14
1.8.6 Improper use.......................................................................................................................................................................14
1.9 Ambient conditions for operation and storage ..............................................................................................14
1.9.1 Ambient conditions for operation ......................................................................................................................................14
1.9.2 Ambient conditions for storage..........................................................................................................................................14
1.10 Combination with other medical devices .......................................................................................................15
1.11 Disposal...........................................................................................................................................................15
2 Safety instructions..................................................................................................... 16
2.1 Structure of the safety instructions in this instruction manual ......................................................................16
2.1.1 Indicating risk of injury .......................................................................................................................................................16
2.1.2 Indicating damage to property ...........................................................................................................................................16
2.1.3 Indicating additional information .......................................................................................................................................16
2.2 Additional symbols for the safety information ...............................................................................................16
2.3 Symbols on the device ....................................................................................................................................17
2.4 Overview of the most important safety instructions......................................................................................17
3 The technology of the lighting system......................................................................... 22
3.1 The light head .................................................................................................................................................22
3.2 The LED light source........................................................................................................................................23
3.3 Accessories......................................................................................................................................................23
4 Identification of the lighting system ........................................................................... 24
4.1 Use of serial numbers .....................................................................................................................................24
4.1.1 Position of the serial numbers on the ceiling-mounted version.........................................................................................24
4.1.2 Position of the serial numbers on the wall-mounted version ............................................................................................24
4.1.3 Position of the serial numbers on the mobile stand version ..............................................................................................25

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4.1.4 Position of the laser marking..............................................................................................................................................25
5 Description of devices and functions........................................................................... 26
5.1 Description of the ceiling-mounted version ...................................................................................................26
5.1.1 Implementation of the ceiling-mounted version................................................................................................................26
5.1.2 Components of the ceiling-mounted version .....................................................................................................................26
5.1.3 Camera on light head, optional ..........................................................................................................................................26
5.1.4 Size of the light heads.........................................................................................................................................................26
5.1.5 Rotation / swivel ranges of the ceiling-mounted version...................................................................................................27
5.2 Description of the wall-mounted version .......................................................................................................28
5.2.1 Implementation of the wall-mounted version ...................................................................................................................28
5.2.2 Components of the wall-mounted version.........................................................................................................................28
5.2.3 Size of the light heads.........................................................................................................................................................28
5.2.4 Rotary / swivel movement of the wall-mounted version...................................................................................................29
5.3 Description of mobile stand version ...............................................................................................................30
5.3.1 Implementation of the mobile stand version.....................................................................................................................30
5.3.2 Components of the mobile stand version...........................................................................................................................30
5.3.3 Power supply of the mobile stand version .........................................................................................................................30
5.3.4 Size of the light heads.........................................................................................................................................................30
5.3.5 Rotating / swivel movement of the mobile stand version..................................................................................................31
5.4 Functional specifications of the light head .....................................................................................................32
5.4.1 Positioning the light head...................................................................................................................................................32
5.4.2 Operating the light heads ...................................................................................................................................................32
5.4.3 Controlling the light intensity .............................................................................................................................................34
5.4.4 Sterile Light Control (SLC) function, optional......................................................................................................................35
5.4.5 Adaptive Light Control (ALC) function, optional.................................................................................................................36
5.4.6 Adaptive Light Control plus (ALC plus) function, optional..................................................................................................37
5.4.7 Controlling the light field....................................................................................................................................................38
5.4.8 Controlling the colour temperature (optional)...................................................................................................................39
5.4.9 Synchronisation of the colour temperature .......................................................................................................................40
6 Commissioning .......................................................................................................... 41
6.1 Checking the lighting systems.........................................................................................................................41
6.2 Positioning of the lighting systems .................................................................................................................42
6.2.1 Risks of collision during positioning....................................................................................................................................42
6.2.2 Positioning the cover-mounted / wall-mounted version....................................................................................................43
6.3 Positioning the mobile stand version..............................................................................................................45
6.3.1 Connecting the mobile stand version to the mains............................................................................................................46
7 Decommissioning....................................................................................................... 47
7.1 Switching off the ceiling- and wall-mounted version......................................................................................47
7.2 Switch off the mobile stand version ...............................................................................................................47
8 Operation.................................................................................................................. 48
8.1 Working rules..................................................................................................................................................48
8.2 Preparatory measures.....................................................................................................................................48
8.3 Measures to take when using the lighting system..........................................................................................49
8.4 Attaching the sterile handle............................................................................................................................50
8.5 Control panels of the lighting system .............................................................................................................51
8.6 Switching the light head on/off ......................................................................................................................52
8.7 Disconnecting the power to the lighting system ............................................................................................52
8.8 Setting the size of the light field .....................................................................................................................53
8.9 Setting the light intensity................................................................................................................................54

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8.9.1 Non-sterile setting of the light intensity at the control panel ............................................................................................54
8.9.2 Set the light intensity in the sterile area using the Sterile Light Control (SLC) ...................................................................55
8.9.3 Setting the light intensity to the working distance in the non-sterile area with Adaptive Light Control (ALC)..................56
8.9.4 Adjusting the light intensity with Adaptive Light Control plus (ALC plus) ..........................................................................57
8.9.5 Setting colour temperature ................................................................................................................................................59
8.9.6 Synchronisation of the colour temperature .......................................................................................................................59
9 Cleaning and disinfection ........................................................................................... 60
9.1 Cleaning and disinfection................................................................................................................................61
9.1.1 General ...............................................................................................................................................................................61
9.1.2 Wipe-over disinfection .......................................................................................................................................................61
9.1.3 Recommended disinfectants ..............................................................................................................................................62
10 Sterilising handles of surgical lights ............................................................................ 63
10.1 Preparation .....................................................................................................................................................63
10.2 Cleaning and disinfection................................................................................................................................63
10.2.1 Cleaning ..............................................................................................................................................................................63
10.2.2 Disinfection.........................................................................................................................................................................63
10.3 Sterilisation .....................................................................................................................................................64
10.3.1 General information ...........................................................................................................................................................64
10.3.2 Steam sterilisation ..............................................................................................................................................................64
10.3.3 Sterilisation packaging........................................................................................................................................................65
11 Inspections, maintenance and repairs......................................................................... 66
11.1 Inspections during operation..........................................................................................................................66
11.2 Annual visual inspection .................................................................................................................................66
11.3 Maintenance every two years.........................................................................................................................67
11.4 Repairs ............................................................................................................................................................67
12 Adjustments .............................................................................................................. 68
12.1 Setting spring arm swivel range type AC 2000 LCH.........................................................................................68
12.1.1 Disconnecting the power to the lighting system ................................................................................................................68
12.1.2 Setting the swivel range......................................................................................................................................................68
12.2 Setting spring arm swivel range type AC 2000 and type AC 3000 ..................................................................69
12.2.1 Disconnecting the power to the lighting system ................................................................................................................69
12.2.2 Setting the swivel range......................................................................................................................................................69
12.3 Setting spring arm swivel range type AC 5000 ................................................................................................70
12.3.1 Disconnecting the power to the lighting system ................................................................................................................70
12.3.2 Removing the covers ..........................................................................................................................................................70
12.3.3 Setting the swivel range......................................................................................................................................................70
12.3.4 Installing the covers............................................................................................................................................................70
12.4 Setting spring arm spring force type AC 2000 LCH .........................................................................................71
12.4.1 Disconnecting the power to the lighting system ................................................................................................................71
12.4.2 Adjusting the spring force...................................................................................................................................................71
12.5 Setting spring arm spring force type AC 2000 and type AC 3000 ...................................................................72
12.5.1 Disconnecting the power to the lighting system ................................................................................................................72
12.5.2 Adjusting the spring force...................................................................................................................................................72
12.6 Setting the spring arm spring force type AC 5000 ..........................................................................................73
12.6.1 Disconnecting the power to the lighting system ................................................................................................................73
12.6.2 Adjusting the spring force...................................................................................................................................................73
12.7 Adjusting the brake force of the friction brakes .............................................................................................74
12.7.1 Disconnecting the power to the lighting system ................................................................................................................74
12.7.2 Adjusting the braking force for the boom ..........................................................................................................................74

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12.7.3 Adjusting the braking force for the spring arm...................................................................................................................75
12.7.4 Adjusting the brake of the convenience bracket on AC 3000.............................................................................................75
12.7.5 Adjusting the brake force of the cardan joint rod ..............................................................................................................76
12.7.6 Setting the braking force of the cardan joint axle on the standard light head...................................................................77
12.7.7 Setting the braking force on the light head SLC / ALC plus.................................................................................................78
12.7.8 Setting the cardan joint axis braking force on the standard light head with camera.........................................................79
13 Consumables ............................................................................................................. 80
14 Troubleshooting ........................................................................................................ 81
15 Technical data ........................................................................................................... 82
15.1 Equipment versions for the light models........................................................................................................82
15.2 Device data .....................................................................................................................................................82
15.3 EMC information.............................................................................................................................................86

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1 Important information regarding safe use
1.1 Details for the identification of the system
This instruction manual is solely intended for systems with rating plates that show the
following information:
System identification – TruLight single 4038110
– TruLight mobile [phone]
–TruLight wall 4038130
– TruLight duo 4038210
– TruLight trio / quad 4038310
1.2 Details for identification of the instruction manual
Updated status of this instruction manual To indicate the updated status of the instruction manual, all pages are marked with a
7-figure identification number and the status:
Identification of the instruction manual – Material no.: 1756789
– Date of publication: 2017-09-06
– Document number: 55000-00011_002_01
This identification coding is binding for the validity of the instruction manual and
must not be removed irrespective of the type of publication (in printed or electronic
form, in full or excerpted).
1.3 Designation of groups of individuals
The following groups of individuals are named in this instruction manual.
1.3.1 Operator
An operator (e.g. a medical practice, hospital, etc.) is any natural or legal person who
owns a device and is authorised to use it or by whose authority the device is used.
• The operator is obliged to provide a safe device and appropriately instruct the
user regarding operation and proper use of the device.
1.3.2 User
Users are individuals who by their qualifications or an appropriate briefing by
specialist personnel are authorised to operate and work with the device.
• Users are fully responsible for the safe application of the device for the purpose
intended.
1.3.3 Specialist personnel
Specialist personnel means authorised individuals, generally employed by the
operator, who:
• have acquired their knowledge by a technical education in the field of medical
technology,
• can assess the work they carry out on the basis of professional experience and
briefing about safety regulations, and can recognize possible hazards in their
work.
• In countries where there is certification regarding performance of work in the
field of medical technology, classification as specialist personnel requires the
corresponding authorization.
1.4 Information for operators
Procedural guidelines The device has been manufactured to the current state of technology and is
operationally safe.
• The device can nevertheless be a source of danger, especially when it is operated
by inadequately trained personnel or is used incorrectly or not for the purpose
intended.

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• The device may only be operated, cleaned, disinfected and maintained by
qualified personnel.
1.4.1 Initial commissioning
Scope This instruction manual is only valid after successful initial operation by the operator
or an installer authorised by the manufacturer.
• The device must be thoroughly cleaned and disinfected before its first use.
• Once the device has been released for use, the information in this instruction
manual will be binding for the user.
1.4.2 Availability of the instruction manual
Obligation to inform The instruction manual is part of the device and must therefore be kept in a place in
the immediate vicinity of the device to allow consultation regarding safety
instructions and important operating information at any time.
• Never hand the device to third parties without the valid instruction manual.
Ensure that the instruction manual provided with the device is valid by checking
the identity and version number.
1.4.3 Guarantee
Guarantee Trumpf Medical guarantees the safety and functionality of the device as long as the
following conditions are met:
• the device is exclusively used for the purpose intended and is operated and
maintained in accordance with the provisions of this instruction manual
• only original spare parts or accessories approved by Trumpf Medical are used
• no modifications are made to the device
• inspections and maintenance work are carried out at the time intervals specified
• an initial commissioning is carried out and the device is released for operation
with a handover declaration
1.4.4 Maintenance and repair
The device or parts thereof may only be maintained or repaired by:
• Trumpf Medical Customer Service
• authorised service companies trained by Trumpf Medical
• the operator's service personnel when trained and authorised by Trumpf Medical
1.4.5 Service life of the device
Trumpf Medical products are designed in compliance with all safety and maintenance
requirements for a service life of 10 years.
• This life span includes the functionality of the product when used according to
the specifications in the instruction manual, a guaranteed service and the supply
with spare parts.
• Trumpf Medical makes use of a quality management system certified in
accordance with DIN EN ISO 13485 for all company processes.
•This guarantees:
– Top quality
–Easy operation
– Functional design
– Optimisation for the intended purpose
1.5 Date of manufacture
The rating plate indicates the date of manufacture of the device. The position of the
rating plate on the device is shown in Chapter 4.1, page 24.

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1.6 Delivery
Before installation, check the delivered components for completeness and for any
possible transportation damage.
• To check the delivery, unpack all components and carry out visual inspection.
• The components can be identified on the basis of the order number on the
delivery note and / or the order-specific dimension sheet.
1.6.1 Transportation damage
Damage claims Claims for damage cannot be accepted unless Trumpf Medical is notified without
delay. In the event of damage during transport or missing components, please send
Trumpf Medical a report containing the following information:
Accompanying documents • Damage record giving details of damage or defects.
• Primary serial number of the device or system or the serial numbers of the
damaged components,
• Order number (shown on the delivery note and/or the order-specific dimension
sheet)
• Name and address of the customer,
• Consignee.
1.6.2 Return address
Returns In the event of a return, use the original packaging if possible.
Address returns to:
TRUMPF Medizin Systeme GmbH + Co. KG
Carl-Zeiss-Straße 7–9
07318 Saalfeld
Germany
1.7 Information for users
Note that the device may only be operated by persons who have had the
corresponding instruction.
1.7.1 Training for use of the device
Instruction Training must be carried out directly at the device by qualified staff of the operator or
by an installer of the device who has been authorised by the manufacturer.
• At the end of the briefing, it must be documented that the user in question has
understood the special operating measures necessary regarding use for the
intended purpose.
1.7.2 Obligation of the user to inform and to inspect
Dealing with problems The instruction manual must be carefully read before commissioning to prevent
possible injuries and damage to goods.
• Check the functional capability and correct condition of the device before every
application or handover for use.
• While the device is in use, do not fail to comply with the provisions of the
instruction manual.
• Get the information you require from the operator’s technical service or from
Trumpf Medical in the event of specific problems that are not treated in sufficient
detail in this instruction manual.
1.8 Purpose of the device
1.8.1 Identification
Conformity The manufacturer declares that this product complies with the fundamental
requirements according to MDD Appendix I and documents this by means of the CE
and UL marking.

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CE mark: This device is a Class I medical device as defined by the European Medical
Device Directive (MDD).
UL mark UL marking: device has been tested by Underwriter Laboratories Inc. for the USA and
(only NRTL region) Canada with regard to electric shock and fire hazard as well as mechanical hazards.
1.8.2 Standards and Directives
The device complies with the safety requirements of the following standards and
directives:
MDD
• COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices
RoHS
• DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND COUNCIL dated 8
June 2011 to restrict the use of specific harmful substances in electrical and
electronic devices
– EN 50581 Technical documentation for the assessment of electrical and
electronic products with respect to the restriction of hazardous substances
Electrical safety
• EN 60601-1 Medical electrical equipment — Part 1: General requirements for
basic safety and essential performance
• EN 60601-1-2 (IEC 60601-1-2) - Medical electrical equipment - Electromagnetic
compatibility
1.8.3 Internationally applied standards
• UL 60601-1
• ANSI / AMI ES 60601-1
• CAN/ CSA-C22.2 No. 60601-1
• IEC 60601-1
• IEC 60601-1-2
1.8.4 Intended use
Intended use The device is intended for use in a patient environment in hospitals or medical
practices to illuminate a part of the patient with high light intensity for examination
or surgical purposes.
The working range lies at a distance between 70 cm to 150 cm to the wound area. The
device is suitable for continuous operation.
Application does not involve the patient; unintentional contact is possible.
Each use exceeding the aforementioned conditions is not considered to be intended
use. Only the user or operator will be liable for any loss or damage arising as a result.
Cleaning As part of daily clinical routine, the equipment is cleaned several times. This is most
often done by turning around housing parts for wiping and drying that are usually
facing down.
Single light
Definition: small surgical light A small surgical light is a single lamp for use in operating theatres to support
diagnoses or treatments that do not pose a risk to the patient due to interruptions by
lighting failure (IEC 60601-2-41).

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Surgical lighting system
Definition: Surgical lighting system A surgical lighting system consists of two or multiple small surgical lamps and is
usable without restrictions.
1.8.5 Special features
High light intensity The light heads provide high light intensity to ensure good visual conditions for the
surgeon.
Overlap of the light fields • Visible light generates heat in the operating area, due to physical effects. High
irradiation densities are generated when the light fields of several light heads
overlap. This can cause drying of tissue and, particularly after prolonged
exposure, reduced perfusion and tissue damage. The light intensity must be
reduced when perfusion is reduced or the tissue starts to dry out.
Surgical interventions in the field of vision • For operations in the field of vision with unprotected and open eyes, high levels
of local light intensities of surgical lamps or direct visual contact with the laser
beam may lead to damage to eyesight. The patient's eyes must be closed or
protected as necessary (e.g. with safety goggles with an optical density of at least
2 or designed according to protection level 6 EN169).
• The laser used in the ALC plus function to measure distance is classified as a class
2 laser, and has the following specifications:
– max. output power 0.95 mW
– wave length -620-690 nm,
– beam divergence 0.16 x 0.6 mRad
– pulse duration 0.4 x 10 ^ -9 s
– pulse refresh rate 320 MHz.
1.8.6 Improper use
Improper use • Additional load on the light support is not permitted.
• The device may not be exposed to severe vibration.
Restriction • The device is not suitable for operation in areas at risk of explosions
• The device should not be used in the vicinity of strong magnetic fields
• The device is not suitable for use in rooms or areas in which inflammable
mixtures of anaesthetics with air or oxygen or laughing gas (N20) are used.
• Mixtures of combustible anaesthetic vapours with oxygen or laughing gas may
arise in the vicinity of the device in such a high concentration that ignition could
occur under certain circumstances. The danger area according to EN 11197 lies in
an area between 5 cm and 25 cm from the point of outflow or escape of the gas.
1.9 Ambient conditions for operation and storage
Various ambient conditions apply to the operation and temporary storage of the
device.
1.9.1 Ambient conditions for operation
• Ambient temperature: 10°C to 40°C;
• Relative humidity: 30 % to 75 %;
• Air pressure: 700 hPa to 1060 hPa
• Operating height up to 3000 m above sea level
1.9.2 Ambient conditions for storage
• Ambient temperature: -15°C to 60°C;
• Relative humidity: 5 % to 95 %;
• Air pressure: 500 hPa to 1060 hPa

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1.10 Combination with other medical devices
Observe the instruction manuals of
combined medical devices
• The system can be combined with medical devices from other manufacturers
(e.g. monitoring systems). The operation of the devices is described in the
relevant instruction manual.
• Only medical devices approved in accordance with IEC 60601-1 or UL 60601-1
may be attached to the system. If a medical device is installed afterwards, the
installation must be performed as specified in IEC 60601-1 and IEC 60601-1-1 or in
accordance with the specifications provided by the manufacturer. Compliance with
this standard must be ensured by the service technician responsible.
• No BF or CF Class application components according to IEC 60601-1 may be
directly connected.
• Devices of third-party manufacturers in the patient environment must have safety
levels equivalent to that of the TruLight 5000/3000 lighting systems.
• Devices of third-party manufacturers outside the patient environment must have
safety levels appropriate for the devices and compliant with the relevant IEC or
ISO safety standards.
1.11 Disposal
The device should be disposed of in accordance with the pertinent national
regulations and at a suitable waste disposal point for the recycling of electrical and
electronic devices.
RoHS conformity • The device meets the requirements of Directive 2011/65/EU RoHS (restriction of
the use of certain hazardous substances in electrical and electronic devices).

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2 Safety instructions
2.1 Structure of the safety instructions in this instruction
manual
Important information is shown in this instruction manual by means of symbols and
signal words.
2.1.1 Indicating risk of injury
Signal words such as DANGER, WARNING or CAUTION indicate the severity of the
hazard. Various triangle symbols are used to add visual emphasis.
DANGER indicates an immediately dangerous situation in which non-compliance can
cause death or serious injury.
WARNING indicates a potentially dangerous situation in which non-compliance may
cause death or serious injury.
CAUTION indicates a potentially dangerous situation in which non-compliance may
cause minor injury.
2.1.2 Indicating damage to property
ATTENTION indicates a potentially dangerous situation in which non-compliance
may cause damage to property.
2.1.3 Indicating additional information
NOTE provides you with additional information and helpful tips for safe and efficient
use of the device.
2.2 Additional symbols for the safety information
Gas explosion: warns against the explosive ignition of gas mixtures.
Electric shock: warns against an electric shock, which can cause serious injury or
even death.
The spring arm may bounce up: warns of the spring arm jumping up while
dismantling the light head / flat screen.
Lighting system falling down: warns of a sudden downwards movement of the light
system when it is exposed to additional load.
Patient eye protection: warns of damage to the patient's vision in examinations or
surgery in the field of vision
Optical radiation: warns of possible damage to the retina by photobiologically active
radiation (blue light of LEDs)
DANGER
WARNING
CAUTION
ATTENTION
NOTE

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Risk of pinching: warns of pinching the fingers in the device.
Damage to surfaces: warns against damages to surfaces caused by unsuitable
cleaning agents and disinfectants.
2.3 Symbols on the device
CE conformity mark: certifies that the device complies with the European Medical
Device Directive (MDD).
Comply with instruction manual: makes reference to this instruction manual.
UL marking: The device has been tested by Underwriter Laboratories Inc. for the USA
and Canada. UL/cUL classification regarding electric shock, fire hazard and
mechanical hazard only in accordance with UL 60601-1, 1st Edition, 2006-04-26, ANSI
/AMI ES60601-1: 2005/(R) 2012 and CAN/CSA-C22.2 No. 60601-1: 2008.
Makes reference to the need for users to read through the instruction manual for
important safety information, such as warnings and precautionary measures which it
may not be possible to apply to the medical device for a range of reasons.
Installation / dismantling of the securing ring: Only to be performed by authorised
service personnel. The detailed instructions relating to the installation / dismantling
of a securing ring must be complied with.
Sensor marking: identifies the class of the laser product installed for distance
measurement according to IEC 60825-1, Edition 2.0 (2007-03) and IEC 60825-1,
Edition 3 (2014).
2.4 Overview of the most important safety instructions
Location requirements
Gas explosion
The lighting system is not suitable for use in an environment
in which flammable mixtures of anaesthetics with oxygen or
laughing gas in a high concentration are used.
Mixtures of combustible anaesthetic vapours with oxygen or laughing gas
may arise in the vicinity of the device in a sufficiently high concentration
that ignition may occur under certain circumstances.
The danger area according to EN 11197 lies in an area between 5 cm and
25 cm from the point of outflow or escape of the gas.
Strong magnetic fields
The support arm systems of the lighting systems must not be used in the
vicinity of strong magnetic fields.
ca. mm8
1 x
1. 2.
!
!
3.
2 x KLICK!
DANGER

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BF/CF Class application components
No BF or CF Class application components in accordance with IEC 60601-1
may be directly connected to the support arm systems of the lighting
system.
Electric shock
The lighting system may only be connected to an
appropriately earthed power supply with protective
conductors in order to avoid the risk of an electric shock.
Electrostatic charge balance
Complications due to electrostatic discharge
To avoid complications due to electrostatic discharge between parts of
the device and patients, the user must not touch parts of the surgical light
and the patient at the same time.
Surgical interventions in the field of vision
Damage to vision
In case of surgery in the field of vision of the patient, the high
light intensity by the light heads may cause eye fatigue or
damage to vision:
• The eyes of the patients must be closed, covered or protected, e.g.
with protective goggles.
• Do not look directly into the light-emitting surface area of the light.
Overlapping fields of illumination from several light heads
Damage to patient's tissue
Overlapping fields of illumination from several light heads with high
intensity illumination may cause damage to tissue. In the event of
incipient tissue dehydration:
• Separate the fields of illumination from several light heads.
• Reduce the light intensity of the light heads.
WARNING
WARNING
WARNING
WARNING

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Contact with laser beams
Damage to vision
Direct contact with the laser beam may cause damage to
vision:
• Do not look directly into the laser beam
• Protect the patient's eyes:
The patient's eyes must be closed or protected as necessary (e.g.
with safety goggles with an optical density of at least 2 or designed
according to protection level 6 EN169).
• Use of operating methods or procedures other than those stated in
these instructions for use may result in dangerous radiation effects
due to the laser.
Light intensity of the light head
LED failure
After failure of the tenth LED, the light head does not achieve the
specified light intensity.
• Take the lighting system out of service.
• Inform Trumpf Medical Customer Service. Exchanging a light head or
repairs to the lighting system may only be performed by Trumpf
Medial Customer Service or by service staff trained and authorised
by Trumpf Medical.
Additional loads
Crashing of the light system
Do not place any additional weight on the light system
Swivel movement of the light head
Risk of injury due to uncontrolled swivel movement
Uncontrolled movement of the spring arm may result when
the spring force of the spring arm is not correctly adjusted.
Risk of jamming
When rotating the light head, the distance between the
cardan joint and the light head changes:
• Do not insert your fingers between the cardan joint and the light
head when swivelling the light head.
WARNING
CAUTION
WARNING
WARNING

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• Only position the light head by using the sterile handle or the non-
sterile handles (outer handles).
Cleaning and disinfection
Improperly used cleaning agents or disinfectants can pose a risk
for patients or damage products
If the following information and instructions are not observed or
complied with, this may result in a risk of contamination or infection for
the patient or damage to the product. Furthermore, it would render any
claim for damages void!
• Use the wipe-over method only for disinfection.
• For cleaning and disinfection, only wipe with a damp but not wet
cloth.
• Dispense cleaning agents and disinfectants so that no liquid can
enter through joints or openings of the surgical light or parts of the
support arm system.
• Use the surface disinfectant only at the concentration specified by
the manufacturer.
• Only use disinfectants approved by the manufacturer for use with
the following materials:
Polycarbonate (PC), polyamide (PA), acrylonitrile butadiene styrene
copolymer (ABS), polystyrene (PS), polyurethane (PUR),
polyphenylene sulphone (PPSU), polybutylene terephthalate (PBT)
and silicones.
• In the event of an increased layer formation of surface disinfectant,
thorough cleaning must be performed.
• Due to the risk of surface damage:
– Do not use sharp, pointed or abrasive objects,
– Do not use abrasive substances or agents which can remove material,
– Do not use solvents, benzene, paint thinners, alkaline cleaning agents or
cleaning agents containing acids or aldehydes,
– Do not use agents with glycol derivatives, phenols, phenol derivatives or
quaternary compounds,
– To prevent paint or corrosion damage, only use agents that do not contain
chlorides or halogenides.
• It is essential that the hygiene instructions of the operator are
observed.
For more detailed information about cleaning and disinfection, see Chapter 9, page 60
Adjustments
Adjusting the device
The manufacturer guarantees the safety and proper working of the
device only under the condition that the work of adjustment has been
WARNING
CAUTION