Trumpf Trulight5000 Instruction Manual

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Instruction manual

TruLight 5000/3000 lighting system

Read the instruction manual before using the product and store for later reference.

Englisch
en-GB
55000-00011_002_01 – 1756789 – 2017-09-06 2
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: +49 3671 586-0
Fax: +49 3671 586-41165
E-mail: [email protected]

Technical Customer Service


TRUMPF Medizin Systeme GmbH + Co. KG
Carl–Zeiss–Straße 7–9
07318 Saalfeld
Germany
Telephone: +49 3671 586-41911
Fax: +49 3671 586-41175
Email: [email protected]

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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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Table of Content

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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Table of Content

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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Table of Content

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 4038120
– 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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1 Important information regarding safe use

• 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 Important information regarding safe use

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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1 Important information regarding safe use

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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1 Important information regarding safe use

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 Important information regarding safe use

1.10 Combination with other medical devices


Observe the instruction manuals of • The system can be combined with medical devices from other manufacturers
combined medical devices (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 DANGER indicates an immediately dangerous situation in which non-compliance can


cause death or serious injury.

 WARNING WARNING indicates a potentially dangerous situation in which non-compliance may


cause death or serious injury.

 CAUTION 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


ATTENTION
may cause damage to property.

2.1.3 Indicating additional information

NOTE provides you with additional information and helpful tips for safe and efficient
NOTE
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)

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2 Safety instructions

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.

1.
1x
2. 3. Installation / dismantling of the securing ring: Only to be performed by authorised
2x! KLICK! !
ca. 8 mm
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

 DANGER
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.

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2 Safety instructions

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.

 WARNING
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

 WARNING
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

 WARNING
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

 WARNING
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.

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2 Safety instructions

Contact with laser beams

 WARNING
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

 CAUTION
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

 WARNING
Crashing of the light system
Do not place any additional weight on the light system

Swivel movement of the light head

 WARNING
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.

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2 Safety instructions

• Only position the light head by using the sterile handle or the non-
sterile handles (outer handles).

Cleaning and disinfection

 WARNING
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

 CAUTION
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

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2 Safety instructions

done by an authorised hospital technician or a person with equivalent


qualification.

Deinstallation for service purposes

 WARNING
The spring arm may bounce up
When the light head/flat screen is removed before moving
the spring arm to the top-most limit stop position, the spring
arm will shoot up and can cause severe injuries:
• The light head/flat screen may therefore only be de-installed by
Trumpf Medical Customer Service.

Commissioning

 CAUTION
Initial commissioning prior to use
The light system must be handed to the user in a tested state after initial
operation before it can be used in routine medical procedures.
• The initial operation includes functional and safety checks on the
entire lighting system.
• Handover must be documented by a handover declaration.

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3 The technology of the lighting system

3.1 The light head


The light head has a wide range of new functions that allow for ergonomic control
using the control panel on the light head or using the optional wall-mounted control
panel.

Operating modes of the non-sterile The light heads are fitted with illuminated, non-sterile handles (outer handles). The
handles (optional) following operating modes are available:
• Permanent illumination (factory setting),
• No illumination,
• Illumination when the light head is switched on,
• Illumination only when the light head is in stand-by mode
• Illumination in stand-by mode or when the ENDO-dimming of the light head is
switched on.
The operating mode selected by the user can be configured by a service technician
during assembly.

ENDO-dimming ENDO-dimming is intended for endoscopic surgical procedures. ENDO-dimming


switches the light head to less than 10 percent of the light intensity.

Light intensity The light intensity can be set in the range from 40% to 100%. A reduction (dimming)
of the light intensity does not change the colour temperature of the light.
The light intensity can be separately set for each light head.

Adaptive Light Control (ALC) The newly developed Adaptive Light Control allows the light settings to be adapted to
(optional) the new working distance when the position of the light head to the wound field is
changed.
The three settings for a working distance of approximately 0.8 metres, 1.0 meter and
1.2 meters are selected on the control panel or the optional wall-mounted control
panel.
The light head then automatically selects the optimum light setting for this working
distance.

Adaptive Light Control plus (ALC plus) Adaptive Light Control plus (ALC plus) enables the targeted electronic control of
(optional) various LEDs in order to achieve optimum illumination of the wound area. The
Adaptive Light Control plus automatically ensures even light intensity and higher light
output for the first time. The distance between the light head and the wound area is
automatically determined based on movement detection when the light head is
moved during surgery. This allows accurate adaptation of the illumination at any
time.

Sterile Light Control (SLC) (optional) Simple swiping with a finger allows the light functions to be activated in a completely
sterile way using the sterile handle.

Adjustable Color Temperature (optional) The function Adjustable Color Temperature is used to increase the colour contrast in
the wound area and provides a better perception of colour differences by the
operating team.

TruVidia camera system With the optional TruVidia camera system, a camera installed in the middle of the
(optional) light head can be controlled using an optional control device. The two camera light
heads TruLight 5310 and TruLight 5510 are fitted as standard with the ALC plus
function, as soon as the camera module is fitted.

Please refer to the overview of light versions in the Technical Data chapter for
detailed information on the availability of this option.

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3 The technology of the lighting system

3.2 The LED light source


The light system is a future-proof light equipped with LEDs (Light Emitting Diodes).

Service life LEDs have a very high service life, unlike conventional halogen or discharge lights.

Low heat generation Further advantages of the LEDs are that they generate less heat by not emitting IR
(infrared) radiation and cause less tissue damage by not emitting UV (ultraviolet)
radiation.

High failure safety The use of a large number of LEDs makes the light head very resistant to failure.
Failure of single LEDs does not affect the function of the light head.

3.3 Accessories
• Dock - Desk
– Material no. 1839155: Dock - Desk
• WallControl Panel
– Material no. 1992641: TCO Wall Control-Universal Front Interf.
– Material no. 1956143: Wall Control -Preinstall Set, FLUSH
– Material no. 1956144: Wall Control -Preinstall Set, SURFACE
• Control incl. Bumper
– Material No. 1835274 TCO Control incl. Bumper
• OPL Interface Converter (optional)
is needed to integrate the surgical light TruLight 5000/3000 in third party
systems.
– Material No. 1793338

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4 Identification of the lighting system

Figure 1 4.1 Use of serial numbers


A light system is identified by its rating plate
and serial numbers.
• The ra ng plate ① contains the specific
device data and also the main serial
number.
The main serial number identifies a
complete device order-specifically.
The main serial number also enables
components which do not have a
serial number themselves to be
identified by Trumpf Medical
Customer Services, permitting the
supply of the correct spare parts.
• The serial numbers ② iden fy the
individual components of a device.

4.1.1 Position of the serial numbers


on the ceiling-mounted version
A: Ceiling-mounted version
• The name plate ① with the main serial
number is on the topmost beam.
• Serial numbers ② of the individual
components are provided at:
– Ceiling conduit
– Interface plate
– Boom
– Spring arm
– Quarter bracket
– Light head

4.1.2 Position of the serial numbers


on the wall-mounted version
B: Wall-mounted version
• The ra ng plate ① with the main serial
number is on the topmost beam.
• Serial numbers ② of the individual
components are provided at:
– Wall support
– Boom
– Spring arm
– Quarter bracket
– Light head

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4 Identification of the lighting system

Figure 2 4.1.3 Position of the serial numbers


on the mobile stand version
C: Mobile stand version
• The ra ng plate ① with the main serial
number is on one side of the power
adapter housing.
• Serial numbers ② of the individual
components are provided at:
– Boom
– Light head
– Stand base

4.1.4 Position of the laser marking


D: Light head with Adaptive Light Control plus
(ALC plus)
• The laser marking ③ is provided in the
suspension area of the light head
housing.

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5 Description of devices and functions

Figure 3 5.1 Description of the ceiling-


mounted version
5.1.1 Implementation of the ceiling-
mounted version
Different models of the ceiling-mounted
version of the lighting system are available:
• A: Surgical light as single light with a small
light head on the AC 2000 type spring arm
• B: Surgical light as single light with a small
light head on the AC 2000 spring arm LCH
(Low Ceiling Height).
• C: Surgical lighting system as a
combination of several large or small light
heads on AC 2000 or AC 2000 LCH (Low
Ceiling Height) spring arms.

5.1.2 Components of the ceiling-


mounted version
The lighting system comprises of:
• Ceiling cover panel ①,
• Ceiling conduit ②,
• Boom ③,
• AC 2000 ④ or AC 2000 LCH (Low Ceiling
Height) spring arm ⑧,
• Convenience bracket ⑤,
• Light head ⑥.

5.1.3 Camera on light head, optional


The light heads can be equipped with an
op onal camera ⑦ (see the Instruc on
Manual: TruVidia SD or TruVidia HD).

5.1.4 Size of the light heads


For both light head 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 light field, light
intensity and colour temperature (see
functional specifications and overview of
technical data).

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5 Description of devices and functions

Figure 4 5.1.5 Rotation / swivel ranges of the


ceiling-mounted version
The horizontally rotatable boom ② together
with the horizontal and vertically adjustable
spring arm ③ or ⑦ facilitate stable
posi oning of the light head ⑤ within the
activity range of the support arm system.
Convenience bracket ④ facilitates accurate
alignment of the light head onto the wound
area.
The following rotation and swivel movements
can be performed at the joints of the support
arms when there is sufficient distance from
neighbouring
walls and objects:
AC 2000 type spring arm
• Hinge A, boom ② at the ceiling conduit
①:
Full horizontal rotation movement
(> 360°)
• Hinge B, AC 2000 type spring arm ③ on
the boom ②:
Horizontal rotation movement
(> 360°).
Vertical swivel movement in the range:
+45° to -50°
• Hinge C, convenience bracket ④ at the
spring arm type AC 2000 ③:
Full horizontal rotation movement
(> 360°)
• Hinge D, light head on the convenience
bracket ④:
TruLight 3000: Full vertical rotation
movement (> 360°)
TruLight 5000: Limited rotation
movement to position stop (< 420°)
• Hinge E, light head on cardan joint light
head:
Swivel movement (200°).
AC 2000 LCH type spring arm
• Hinge A, boom ② at the ceiling conduit
①:
Full horizontal rotation movement (> 360°).
• Hinge B, AC 2000 LCH type spring arm ⑦
on the boom ②:
Full horizontal rotation movement (> 360°).
Vertical swivel movement in the range:
+30° to -45°.
• Hinge D, light head on cardan joint light
head ⑥:
Full vertical rotation movement (> 360°).

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5 Description of devices and functions

• Hinge E, light head on cardan joint light


head:
Swivel movement (200°).
The swivelling ranges of the support arms are
adjustable (see Chpt. 12).

Figure 5 5.2 Description of the wall-


mounted version
5.2.1 Implementation of the wall-
mounted version
Different models of the wall-mounted version
of the lighting system are available:
• Surgical light as single light with a small
light head on the AC 2000 type spring arm

5.2.2 Components of the wall-


mounted version
The lighting system comprises of:
• Wall support ①,
• Boom ②,
• AC 2000 ③ or AC 2000 LCH (Low Ceiling
Height) spring arm,
• Convenience bracket ④,
• Light head ⑤.

5.2.3 Size of the light heads


For both light head 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 light field, light
intensity and colour temperature (see
functional specifications and overview of
technical data).

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5 Description of devices and functions

Figure 6 5.2.4 Rotary / swivel movement of


the wall-mounted version
The horizontally rotatable boom ② together
with the horizontal and vertically adjustable
spring arm ③ facilitate stable posi oning of
the light head ⑤ within the ac vity range of
the support arm system. Convenience bracket
④ facilitates accurate alignment of the light
head onto the wound area.
The following rotation and swivel movements
can be performed at the joints of the support
arms when there is sufficient distance from
neighbouring walls and objects:
AC 2000 type spring arm
• Hinge A, boom ② at the wall support
①:
Horizontal rotation movement (200°).
• Hinge B, AC 2000 type spring arm ③ on
the boom ②:
Full horizontal rotation movement
(> 360°).
Vertical swivel movement in the range:
+45° to -50°.
• Hinge C, convenience bracket ④ at the
spring arm type AC 2000 ③:
Full horizontal rotation movement
(> 360°).
• Hinge D, light head on the convenience
bracket ④:
TruLight 3000: Full vertical rotation
movement (> 360°).
TruLight 5000: Limited rotation
movement to position stop (< 420°).
• Hinge E, light head on cardan joint light
head:
Swivel movement (200°).

The swivelling ranges of the support arms are


adjustable (see Chpt. 12).

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5 Description of devices and functions

Figure 7 5.3 Description of mobile stand


version
5.3.1 Implementation of the mobile
stand version
The mobile stand version is available as an
single light equipped with an AC 2000 LCH
type spring arm.

5.3.2 Components of the mobile


stand version
The mobile stand version consists of:
• Light head ①,
• AC 2000 LCH (Low Ceiling Height) type
spring arm ②,
• stand rod ③,
• power supply housing ④ with mains
cable ⑨. The power supply housing ⑦
contains components for the supply of
electric power.
• Stand base ⑫, with four castors ⑩ (two
of which are lockable ⑪),

5.3.3 Power supply of the mobile


stand version
The power supply of the mobile stand version
is provided at the power supply housing ④:
• by the mains cable with the IEC power
connector ⑥ for connec on to the IEC
power socket ⑦ on the underside of the
power supply housing,
and
• with the earthed plug connector ⑧ for
connection to a mains socket.
• Power unit ON/OFF switch ⑤ on the
underside of the power supply housing
for switching on or off.
If the power supply unit is switched on,
the power supply is on standby.

5.3.4 Size of the light heads


For both light head 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 light field, light
intensity and colour temperature (see
functional specifications and overview of
technical data).

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5 Description of devices and functions

Figure 8 5.3.5 Rotating / swivel movement of


the mobile stand version
The stand base ⑤ with castors facilitates
unrestricted mobility. The horizontally and
vertically adjustable AC 2000 LCH (Low Ceiling
Height) type spring arm ③ on the stand rod
④ allows for stable posi oning of the light
head ① within the ac vity range of the
stand. The cardan joint ② facilitates accurate
alignment of the light head onto the wound
area.

The following rotation and swivel movements


can be performed at the joints of the support
arms when there is sufficient distance from
neighbouring
walls and objects:
• Hinge A, spring arm ③ on stand rod ④:
Horizontal swivel movement in the
range +10° to -10°.
Vertical swivel movement in the range:
+30° to -45°.
• Hinge B, light head on cardan joint ②:
Full vertical rotation movement
(> 360°).
• Hinge C, light head on cardan joint:
Swivel movement (200°).

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5 Description of devices and functions

Figure 9 5.4 Functional specifications of


the light head
5.4.1 Positioning the light head
Sterile positioning
The light head can be positioned with
complete sterility using the sterile handle:
• sterile handle, standard version ④,
• sterile handle with function: Sterile Light
Control (SLC) ⑥.
Non-sterile positioning (optional illuminated
outer handles)
The light heads can be positioned with the
non-sterile outer handles.
• TruLight 3000:
– Outer handles ① on the light head
③.
• TruLight 5000:
– Outer handles ① on the light head
⑤.
– Outer handle ⑦ on the control unit
⑧.
TruLight 5000 light head versions are
optionally equipped with illuminated non-
sterile outer handles. The operating mode
options for the outer handles are described in
Chapter 3.1, page 22.

5.4.2 Operating the light heads


Sterile operation at the handle
The light intensity of the TruLight 5000 light
version can be adjusted with the sterile
handle using the optional Sterile Light Control
(SLC) func on ⑥.
Non-sterile operation at the control panels
The lighting function of light types TruLight
3000 and TruLight 5000 can be set at the non-
sterile control panel ② or ⑨ on the light
head or at the optional wall-mounted control
panel ⑩:
• A: TruLight 3000 with control panel ② on
the light head to adjust:
– Light intensity;
– Adaptive Light Control (ALC);
• B: TruLight 5000 with control panel ⑨ on
the control unit ⑧ to adjust:
– Light intensity;
– Colour temperature;
– Colour temperature synchronisation;
– Size of light field;
– Adaptive Light Control Plus (ALC plus);
optional wall-mounted control panels • C: Both light types TruLight 5000 and

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5 Description of devices and functions

TruLight 3000 can be fitted with an optional wall-mounted control panel ⑩.


TruLight 3000, wall-mounted control panel ⑪
The wall-mounted control panel has the same range of functions as the
corresponding control panel on the light head.
– Light intensity;
– Adaptive Light Control (ALC);
TruLight 5000, wall-mounted control panel ⑫
The wall-mounted control panel has the same range of functions as the
corresponding control panel on the light head.
– Light intensity;
– Colour temperature;
– Colour temperature synchronisation;
– Size of light field;
– Adaptive Light Control Plus (ALC plus).

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5 Description of devices and functions

Figure 10 5.4.3 Controlling the light intensity


Non-sterile setting of the light intensity
The light intensity is set at the Light ③
control panel.
• A: for TruLight 3000 ① at the control
panel ② for the light head or the
op onal wall-mounted control panel ④,
or
• B: for TruLight 5000 ⑦ on the control
panel ⑤ of the control unit ⑥, or on the
op onal wall-mounted control panel ⑧.

The intensity of illumination of the light head


can be adjusted in 7 stages:
– < 10 % (Endo)
– 40 %–100 %

Reducing the light intensity:


• Press key ⑨ on the control panel.
→ The LED for the currently set light
intensity ⑪ lights up.
Increasing the light intensity:
• Press key ⑫ on the control panel.
→ The LED for the currently set light
intensity ⑪ lights up.

Endo-dimming
The light intensity level Endo-dimming ⑩ is
intended as the light intensity for endoscopic
operations.
Activating Endo-dimming:
• Press key ⑨ on the control panel un l
the Endo LED lights up.
→ The light intensity is reduced to a value <
10 % of the maximum light intensity.
Deactivating Endo-dimming:
• Press key ⑫ on the control panel un l
the Endo LED goes out.
The light intensity is set to a value in the range
of 40 %–100 % (indicated by the
corresponding lit LED).

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5 Description of devices and functions

Figure 11 5.4.4 Sterile Light Control (SLC)


function, optional
Sterile setting of the light intensity
With the optional sterile handle ② with
Sterile Light Control (SLC), the light intensity
of the TruLight 5000 ⑤ lamp can be adjusted
with complete sterility.

Adjusting the light intensity with Sterile


Light Control
A touch sensor ③ is installed in the area
below the collar of the sterile handle ②. This
can be used to adjust the light intensity by a
simple finger movement ④:
• Increasing the light intensity:
Swipe the finger from left to right.
• Reducing the light intensity:
Swipe the finger from right to left.
The functions can be assigned differently if
this is required by the customer.

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5 Description of devices and functions

Figure 12 5.4.5 Adaptive Light Control (ALC)


function, optional
Non-sterile adjustment of the light
control
The Adaptive Light Control (ALC) function
allows lighting settings of the two light types
TruLight 3000 and TruLight 5000 to be
manually adjusted to the new working
distance, if the position of the light head to
the wound area is changed.
• The three ALC se ngs ③ for an
approximate working distance of 0.8 m,
1.0 m and 1.2 m are selected:
– A: for TruLight 3000 ① on the control
panel ② on the light head or the
optional wall-mounted control panel
④,
or
– B: for TruLight 5000 ⑧ on the control
panel ⑥ of the control unit ⑦, or on
the optional wall-mounted control
panel ⑨.

Adjusting the light intensity with


Adaptive Light Control
TruLight 3000
• Select the relevant key ⑤ on the control
panel ③.
The light head automatically selects an
optimum LED setting for the light
intensity.

TruLight 5000
• Press key ⑩ on the control panel un l
the LED ⑪ for the required distance level
lights up.
The light head automatically selects an
optimum LED setting for the light
intensity.

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5 Description of devices and functions

Figure 13 5.4.6 Adaptive Light Control plus


(ALC plus) function, optional
The light model TruLight 5000 can be
optionally fitted with the Adaptive Light
Control plus (ALC plus) function.
Alongside the basic ALC func on ⑤, the
ALC plus function can automatically control
various LED groups of the light modules
depending on the distance of the light head
① to the wound area ④.
• The laser ③ for detec ng the distance is
installed in the handle adapter of the
handle ②.
• If the light head is repositioned during
surgery, a movement sensor activates the
distance detection. The distance of the
light head from the wound area is
automatically detected with the aid of a
laser beam.
• The light intensity is automatically
adapted to the working distance on the
basis of the measurement data.
• Switchover between automatic distance
detection and manual adjustment of the
distance is performed by pressing the
keys Auto ⑥ or Manual ⑦.

 WARNING
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 (e.g. with
safety goggles with an optical
density of at least 2, or
designed according to
protection level 6 EN169).

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5 Description of devices and functions

Figure 14 5.4.7 Controlling the light field


The TruLight 5000 light model is equipped
with a function for setting the size of the light
field ③:
• Narrow light field, Ø 16 cm at 1 m
distance, for a short distance of the light
head from the wound area,
• Broad light field, Ø 23 cm at 1 m distance,
for a greater distance of the light head
from the wound area,

Adjustment of the size of the light field is


performed on the non-sterile control panel
② of the light head ① or on the relevant
op onal wall-mounted control panel ④.
• Activating the narrow field:
– Press the key ⑤ in the Size section
un l the LED ⑦ lights up.
• Activating the broad field:
– Press the key ⑤ in the Size section
un l the LED ⑥ lights up.

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5 Description of devices and functions

Figure 15 5.4.8 Controlling the colour


temperature (optional)
The TruLight 5000 light models are equipped
with a functionality for variable colour
temperature ③. The value of the colour
temperature can be manually adjusted in the
range from 3500 K up to 5000 K in steps of
500 K.

The colour temperature is set in the non-


sterile area on the control panels ② on the
light head or on the corresponding optional
wall-mounted control panel.
• Increasing the colour temperature:
– Press key ⑦ in the Color section until
the LED ⑥ for the required colour
temperature lights up.
• Reducing the colour temperature:
– Press key ⑤ in the Color section until
the LED ⑥ for the required colour
temperature lights up.

Mode of action of the colour temperature


The variable colour temperature function is
used to increase the colour contrast in the
wound area. The visual contrast behaviour of
the colour temperature is as follows:
• For a wound area which is mainly blue in
colour, a lower colour temperature
(3500 K to 4000 K) increases the colour
contrast and provides a better perception
of colour differences by the operating
team.
• For a wound area which is mainly red in
colour, a higher colour temperature
(4000 K to 4500 K) increases the colour
contrast and provides a better perception
of colour differences by the operating
team.
For normal operations, a colour temperature
in the range 4000 K to 4500 K should be
initially selected.

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5 Description of devices and functions

Figure 16 5.4.9 Synchronisation of the colour


temperature
The TruLight 5000 light models ① are
equipped with a functionality for colour
temperature synchronisa on ③.
For operating table lighting systems which
consist of several lamps, the TruLight 5000
allows the synchronisation of the colour
temperature of the individual light heads.
The synchronisation is set in the non-sterile
area on the control panels ② on the light
head or on the corresponding optional wall-
mounted control panel.
For activation, the colour temperature value
of the light head on which synchronisation is
initiated is definitive.
• Synchronising the colour temperature:
– Press key ⑤ in the Sync section,
– the LED ⑥ lights up and indicates
that the synchronisation is activated.
– Synchronisation is deactivated if the
colour temperature of a light head in
the system is changed.

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6 Commissioning

Figure 17 6.1 Checking the lighting systems


For all versions of the lighting system, a function test and a
visual inspection should be carried out before use, or at least
once per week.

 WARNING
Contamination and infection hazard for
patients
Loose or damaged parts may fall into wounds. To
ensure the safety of patients, check the
components of the lighting system for the
following points before each use:
• Loose parts on the light head ①,
• Visible damage, in particular on the cover
plates ③ of the light heads, the non-sterile
outer handles ② and the sterile handles ④.
• Secure a achment of the sterile handles ④
-------------------------------------------------------------------
Electric shock
There is a risk of electric shock in the event
of contact with damaged electrical
components of the mobile stand version:
• Do not connect the stand to the mains in the
event of defec ve plug connectors ⑤ or ⑥
or damaged mains cables ⑦.
The lighting system is no longer safe to use when
the damage described above or other damage
occurs:
• Disconnect the lighting system by using the
master switch installed in the building, or
remove the safety connector.
• Ensure that the mains switch is not
unintentionally switched on or that the safety
connector is not unintentionally plugged in.
• Label the lighting system as DEFECTIVE!
• Inform Trumpf Medical Customer Service.
-------------------------------------------------------------------
Strong magnetic fields
The support arm systems of the lighting systems
must not be used in the vicinity of strong magnetic
fields.
-------------------------------------------------------------------
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.

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6 Commissioning

Figure 18 6.2 Positioning of the lighting systems


The positioning function of the lighting system is safe to
operate. Pinching injuries during positioning may
nevertheless occur.

 CAUTION
Risk of jamming
When rotating the light head, the
distance between the cardan joint and
the lighting module reduces:
• Do not reach between the cardan joint rod ①
and the ligh ng module ③ while rota ng the
light head.
• Only use the sterilisable handle ④ or the
non-sterile outer handles ② to posi on the
light head.

6.2.1 Risks of collision during positioning


The lighting system has an impact-proof surface coating.
Collisions may nevertheless damage the lighting system.

ATTENTION
Damage to the light head
The area of rotation of the lighting system may be
restricted by other components or adjacent walls.
A collision of the support arm or the light head
may cause damage:
• Avoid collisions with other objects or with
adjacent walls.
• Before adjusting the height, make sure that
there is sufficient distance from the ceiling
and ensure that no other objects are located
above the light head.

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6 Commissioning

Figure 19 6.2.2 Positioning the cover-mounted /


wall-mounted version
Ceiling-mounted version of single light
A: Surgical light as single light with a light head
on the AC 2000 type spring arm
• The best possible mobility of the support
arms is a "V-type arrangement".

Ceiling-mounted lighting system


B: Surgical lighting system as a combination of
several light heads on AC 2000 or AC 2000 LCH
(Low Ceiling Height) type spring arms.
• The best possible mobility of the support
arms is an "M-type arrangement".

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6 Commissioning

Figure 20 Wall-mounted version single light


C: Surgical light as single light with a light head on an AC 2000
or AC 2000 LCH (Low Ceiling Height) type spring arm.
• The best possible mobility of the support arms is a
"V-type arrangement”.

Working distance
Position the light head with the sterile handle or the outer
non-sterile outer handles at a working distance of
70–150 cm from the wound area.

Adaptive Light Control plus (ALC plus), optional


In order to use the functionality of Adaptive Light Control plus
effectively, the integrated distance measurement must make
its measurement within the wound area. The sterile handle of
the light head must therefore be adjusted so that the laser
beam falls inside the wound area.

 WARNING
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.

Switch the power supply to Standby


• Switch on the operating theatre master switch.
• Switch on light head (see chapter Operation).

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6 Commissioning

Figure 21 6.3 Positioning the mobile stand version


The mobile stand version has a high tilting stability. The
following, basic precautions must nevertheless be considered
when positioning the mobile stand version.

ATTENTION
Tilting of the stand
The tilting stability of the mobile stand version can
be at risk due to objects lying on the floor, uneven
floors or the mains cable:
• Always move the mobile stand to the place of
operation with the light head pointing
forwards.
• Do not drive over objects lying on the floor,
uneven parts of the floor or the mains cable.
• Pull the mains plug out of the socket and roll
up the mains cable ④ at the power supply
housing ⑤ to move the stand.
------------------------------------------------------------
The pedestal might lt when the castors ⑦ are
locked and excessive force is exerted onto the
spring arm ② or light head ①:
• Avoid strong leverage onto the spring arm or
the light head.
• Do not add additional loads to the spring arm.

NOTE
Locking the stand base
The two front castors ⑦ can be locked to
immobilise the stand base ⑥.
• Press the brakes ⑧ of both front castors
downwards to lock them.
• Press the brakes ⑧ of both front castors
upwards to unlock them.

Positioning the stand


1. Release the brakes on the two front castors.
2. Grasp the stand by the stand rod ③ and move it with
the light head ① in the direc on of travel to the place of
use.
3. Posi on the light head ① by using the sterile handle or
the outer non-sterile outer handles at a working distance
of 70–150 cm from the wound area.
4. Connect the mobile stand version to the mains.
5. Align the light head ① with the wound area using the
non-sterile handle.

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6 Commissioning

Figure 22 6.3.1 Connecting the mobile stand version to the


mains
The power supply of the mobile stand version is established
by a mains cable ⑥ with an IEC connector ③ and a safety
connector ⑤.

 WARNING
Electric shock
There is a risk of electric shock in the
event of contact with damaged
electrical components:
• Do not connect the lighting system to the
mains in case of defective plug connectors
③/⑤ or in case of damaged mains cables
⑥.
• Label the device as DEFECTIVE and contact
Trumpf Medical Customer Service.
------------------------------------------------------------
Earthing of the mains socket
In case of an electrical short circuit, earthing
reduces the danger of electric shock:
• The mobile stand version (Protection Class I)
may only be connected to a properly earthed
safety socket.

Connect the power supply to the mains


1. Check whether the mains voltage corresponds to the
information on the name plate. Ask the local energy
supply company or a specialist electrical company in
cases of doubt.
2. Lay the mains cable ⑥ so that there is no danger of
tripping and so that there is no strain on the cable.
3. Plug the IEC power connector plug connector ③ into the
socket ④ on the underside of the power supply housing
①.
4. Insert the mains plug ⑥ into a correctly installed and
earthed three-pin plug socket.

Switch the power supply to Standby


• Switch on the power supply unit with the ON/OFF switch
② on the power supply housing.
• Switch on light head (see chapter Operation).

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7 Decommissioning

Figure 23 7.1 Switching off the ceiling- and wall-


mounted version
Disconnecting the power to the lighting system
• Switch off the operating theatre master switch.
→ The lighting system is disconnected from the power
supply.

7.2 Switch off the mobile stand version


Switching the mobile stand version to a current-free
state
• Switch off the power supply unit, position the switch in
position 0 (see Chapter 6.3.1, page 46), pull the mains
cable out of the safety socket.
→ The mobile lighting system is disconnected.
• Coil up the mains cable onto the power supply housing.

Storing the mobile stand version


• Store the mobile stand version at a storage place with
suitable environmental conditions (see Chpt. 1.9.2).
• Lock the two front castors.

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8 Operation

8.1 Working rules


Compliance with safety instructions The safety instructions must be read and adhered to when using the lighting system
to ensure that it is safely handled and to prevent harm to the patient.

8.2 Preparatory measures


Measures that should be considered before using the lighting system.

Checking the lighting system


Function test / visual inspection A function test and a visual inspection should be carried out before use, or at least
once per week.

 WARNING
Contamination and infection hazard for patients
Loose or damaged parts may fall into wounds. To ensure the safety of
patients, check the components of the lighting system for the following
points before each use:
• Loose parts on light head,
• visible damage, in particular on the cover plates of the light head and
the sterile handle,
• secure mounting of the sterilisable handle.
---------------------------------------------------------------------------------------
Electric shock
There is a risk of electric shock in the event of contact with
damaged electrical components of the mobile stand version:
• Do not connect the lighting system to the mains in the event of
damaged plug connectors or a damaged mains cable.
• Take the device out of service and label it as DEFECTIVE.
---------------------------------------------------------------------------------------
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.
---------------------------------------------------------------------------------------
Decommissioning
In the event of functional defects or damage which impair the
operational safety of the lighting system, the device must be immediately
taken out of service:
• Disconnect the lighting system by using the master switch installed in
the building, or remove the safety connector.
• Secure the master switch or the safety connector against accidental
switch-on/plugging in.
• Label the lighting system as DEFECTIVE!
• Inform Trumpf Medical Customer Service.

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8 Operation

8.3 Measures to take when using the lighting system


Measures that should be considered while using the lighting system.

 WARNING
Risk of damage to vision due to high intensity
illumination
In the event of surgery in the field of vision of the patient, the
high intensity of illumination by the light heads may cause
damage to vision:
• Protect the patient's eyes (e.g. with safety goggles).
• Do not look directly into the light-emitting surface area of the light.
---------------------------------------------------------------------------------------
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.
---------------------------------------------------------------------------------------
Damage to eyes due to laser beams
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.
---------------------------------------------------------------------------------------
Complications due to electrostatic discharge with the mobile
stand version
To avoid complications due to electrostatic discharge between parts of
the device and patients, the user must not touch parts of the mobile
stand version and the patient at the same time.
---------------------------------------------------------------------------------------
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.

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8 Operation

Figure 24 8.4 Attaching the sterile handle


Sterile handle standard version
• A: Push the sterile handle ④ onto the handle adapter ①
and press it upward un l the ball latch ② engages
audibly in the hole ③.
• Check the firm attachment of the sterile handle.

Sterile Light Control (SLC) handle, optional


• B: Push the sterile handle ⑧ onto the handle adapter
with distance detec on ⑤ and press it upward un l the
ball latch ⑥ engages audibly in the hole ⑦.
• Check the firm attachment of the sterile handle.

Sterile handle for ceiling-mounted version with optional


camera
The camera as well as the sterile handle for the camera must
be coupled according to 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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8 Operation

Figure 25 8.5 Control panels of the lighting system


The control panels for the lighting functions area equipped
with various control elements, depending on the scope of
functions of the particular light.

A: TruLight 3000
• Control panel ① on the light head,
• Corresponding control panel ② on the op onal wall-
mounted control panel with the following equipment
variants:
– Light intensity
– Adaptive Light Control

B: TruLight 5000
• Control panel on control unit ③,
• Corresponding control panels on the optional wall-
mounted control unit ④-⑦ with various equipment
variants.

• Version ④:
– Light intensity
– Adaptive Light Control
– Size of light field

• Version ⑤:
– Light intensity
– Adaptive Light Control
– Size of light field
– Adaptive Light Control plus

• Version ⑥:
– Light intensity
– Adaptive Light Control
– Size of light field
– Adjustable Color Temperature
– Colour temperature synchronisation

• Version ⑦:
– Light intensity
– Adaptive Light Control
– Size of light field
– Adjustable Color Temperature
– Adaptive Light Control plus
– Colour temperature synchronisation

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8 Operation

Figure 26 8.6 Switching the light head on/off


The lighting system is switched on in two stages:
• Switch the power supply of the lighting system to standby,
• Switch on the light head

Switch the power supply to Standby


Ceiling-mounted and wall-mounted versions:
• Switch on the operating theatre master switch.
→ The power supply of the lighting system is in Standby.

Mobile stand version:


• Connect the mains cable and switch on the power supply. Set the switch to
Position I (see Chapter 6.3.1, page 46),
→ The power supply of the mobile lighting system is in Standby.

Switching on the light head


• Press the ON / OFF bu on ①:
→ The two ligh ng modules ③ of the light head light up.

Switching off the light head


• Press the ON / OFF bu on ①.
→ The two ligh ng modules ③ of the light head go out.

8.7 Disconnecting the power to the lighting system


Ceiling-mounted and wall-mounted versions
• Switch off the operating theatre master switch.
→ The lighting system is disconnected from the power supply.

Mobile stand version


• Switch off the power supply unit, position the switch in Position 0 (see Chapter
6.3.1, page 46), pull the mains cable out of the safety socket.
→ The mobile lighting system is disconnected.

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8 Operation

Figure 27 8.8 Setting the size of the light field


The TruLight 5000 light model is equipped with a function for setting the size of the
light field ③:
• Narrow light field for a short distance of the light head from the wound area,
• wide light field for a short distance of the light head from the wound area,

Selecting the light field


• Activating the narrow field:
– Press the key ② in the Size sec on un l the LED ④ lights up.
• Activating the broad field:
– Press the key ② in the Size sec on un l the LED ③ lights up.

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8 Operation

Figure 28 8.9 Setting the light intensity


Working distance
Position the light head with the sterile handle or the outer non-sterile outer handles
at a working distance of 70 cm–150 cm from the wound area.

 CAUTION
High light intensities with overlapping fields of illumination
When working with overlapping fields of illumination, high light
intensities may accelerate tiring of the eyes.
• Reduce the light intensity of the light heads.

8.9.1 Non-sterile setting of the light intensity at the control panel


The light intensity is set at the Light ① control panel. The intensity of illumina on of
the light head can be adjusted in 7 stages:
– < 10 % (Endo)
– 40 %–100 %

Reducing the light intensity:


• Press key ② on the control panel.
→ The LED for the currently set light intensity ④ lights up
Increasing the light intensity:
• Press key ⑤ on the control panel.
→ The LED for the currently set light intensity ④ lights up

Endo-dimming
The light intensity level Endo-dimming ③ is intended as the light intensity for
endoscopic operations.
Activating Endo-dimming:
• Press key ③ on the control panel un l the Endo LED illuminates.
→ The light intensity is reduced to a value < 10 %.
Deactivating Endo-dimming:
• Press key ⑤ on the control panel un l the Endo LED goes out.
→ The light intensity is set to a value in the range of 40 %–100 % (indicated by the
corresponding lit LED).

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8 Operation

Figure 29 8.9.2 Set the light intensity in the sterile area using
the Sterile Light Control (SLC)
The light intensity can be set in the sterile area for the light
model TruLight 5x20 ①.
The sterile handle ② with Sterile Light Control func on can
be used to set light intensity with simple finger movements
④. A touch sensor ③ is installed below the collar of the
sterile handle to regulate the light intensity.

Increasing the light intensity:


• Swipe from left to right.
Reducing the light intensity:
• Swipe the finger from right to left.

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8 Operation

Figure 30 8.9.3 Setting the light intensity to the working distance in the non-
sterile area with Adaptive Light Control (ALC)
The Adaptive Light Control (ALC ) function automatically adapts the light intensity
when the position of the light head is changed relative to the wound area. Three
distance levels can be selected with the ALC func on ①:
– Long distance (approximately 120 cm);
– Medium distance (approximately 100 cm);
– Short distance (approximately 80 cm);

TruLight 3000
Setting distance levels:
• Select the relevant key ② on the control panel ①.
→ The light head automatically selects an optimum LED setting for the light
intensity.

TruLight 5000
Setting distance levels:
• Press key ④ on the control panel un l the LED ⑤ for the required distance level
lights up.
→ The light head automatically selects an optimum LED setting for the light
intensity.

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8 Operation

8.9.4 Adjusting the light intensity with Adaptive Light Control plus
(ALC plus)
Adaptive Light Control plus (ALC plus) has the same functionality as Adaptive Light
Control (ALC), but also enables the targeted electronic control of various LEDs in
order to achieve optimum illumination of the wound area.

 WARNING
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:
Close the patient's eyes or protect them 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.

NOTE
ALC plus function
The Adaptive Light Control plus (ALC plus) function is only available for
light models TruLight 5x10 and TruLight 5x20.

Camera system Adjusting the light intensity for camera system with Adaptive Light Control
plus (ALC plus)
The functionality of Adaptive Light Control plus (ALC plus) in the camera is based on
evaluating image signals.
• If the light head is repositioned during surgery, the measuring mode of the
camera is activated and automatically remeasures the distances between the
light head and the wound area.
• The light intensity is automatically adapted to the working distance on the basis
of the established measurement data (see also instruction manual: TruVidia SD
or TruVidia HD).

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8 Operation

Figure 31 Fine positioning Adaptive Light Control Plus (ALC plus)


To use Adaptive Light Control plus (ALC plus), point the light
head precisely at the wound area ④ using the sterile handle
②.

Activating the ALC plus function:


1. Press the key ⑥ Auto.
→ The LED ⑦ lights up and indicates that ALC plus is
activated.
2. Briefly readjust the position of the light head:
→ The laser beam is switched on automatically and
measures the distance of the light head from the wound
area ④ again.
→ The light intensity is immediately and precisely adapted
to the working distance on the basis of the measurement
data.
Deactivate the ALC plus function:
3. Press the key ⑥ Auto.
→ The LED ⑦ goes out and indicates that ALC plus is
deactivated.
→ Only the functions of Adaptive Light Control (ALC) are
now available.

NOTE
Manual/auto switchover
Switchover between automatic distance detection
and manual adjustment of the distance is
performed by pressing the keys Auto ⑥ or Manual
⑧.

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8 Operation

Figure 32 8.9.5 Setting colour temperature


Only the light models TruLight 5000 have the Adjustable Color Temperature function
(optional). The value of the colour temperature can be manually adjusted in the
range from 3500 K up to 5000 K in steps of 500 K.

The colour temperature is set in the non-sterile area on the control panels ① on the
light head or on the corresponding optional wall-mounted control panel.
• Increasing the colour temperature:
– Press key ④ in the Color sec on un l the LED ③ for the required colour
temperature lights up.
• Reducing the colour temperature:
– Press key ② in the Color sec on un l the LED ③ for the required colour
temperature flashes up.

Mode of action of the colour temperature


The Adjustable Color Temperature function is used to increase the colour contrast in
the wound area. The visual contrast behaviour of the colour temperature is as
follows:
• For a wound area which is mainly blue in colour, a lower colour temperature
(3500 K to 4000 K) increases the colour contrast and provides a better perception
of colour differences by the operating team.
• For a wound area which is mainly red in colour, a higher colour temperature
(4000 K to 4500 K) increases the colour contrast and provides a better perception
of colour differences by the operating team.

8.9.6 Synchronisation of the colour temperature


The TruLight 5000 light models are equipped with a functionality for colour
temperature synchronisation.
For operating table lighting systems which consist of several lamps, the colour
temperature of the individual light heads can thereby be synchronised.
The synchronisa on se ng is made in the non-sterile area on the control panels ⑤
on the light head or on the corresponding optional wall-mounted control panel.
For activation, the colour temperature value of the light head on which
synchronisation is initiated is definitive.
• Synchronising the colour temperature:
– Press key ⑥ in the Sync section,
– the LED ⑦ lights up and indicates that the synchronisa on is ac vated.
– Synchronisation is deactivated if the colour temperature of a light head in the
system is changed.

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9 Cleaning and disinfection

Regular cleaning and disinfection with suitable cleaning or disinfection agents is


necessary for the safe use of the surgical light.

 WARNING
Electric shock
Touching live components may result in an electric shock.

• Disconnect the device before cleaning and disinfection:


• Ensure that no cleaning or disinfectant fluids penetrate into the
device or into the support arm system.
• Do not place any objects in the equipment openings.
Ceiling-mounted and wall-mounted versions
• Switch off the operating theatre master switch.
→ The lighting system is disconnected from the power supply.

Mobile stand version


• Switch off the power supply unit, position the switch in Position 0 (see Chapter
6.3.1, page 46), pull the mains cable out of the safety socket.
→ The mobile lighting system is disconnected.

 WARNING
Improperly used cleaning agents or disinfectants can
pose a risk for patients or damage products
If the information and instructions contained in this chapter
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!
• Dispense cleaning agents and disinfectants such that no liquid can
enter through joints or openings of the surgical lamp 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 excessive coating of surface disinfectant forming,
carry out a thorough cleaning.
• 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.

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9 Cleaning and disinfection

• It is essential that the hygiene instructions of the operator are


observed.

9.1 Cleaning and disinfection


9.1.1 General
Performed by hygiene specialist staff Cleaning and disinfection of the surgical lights may only be performed by a hygiene
specialist or a person instructed by the hygiene specialist.

Only use recommended cleaning agents For cleaning and disinfection you should only use agents and chemicals tested by and
and disinfectants approved by Trumpf Medical with regard to their material compatibility in
accordance with Chapter 9.1.3, page 62. If an agent is not included on the list it
should not be used as otherwise functional components could be changed or
damaged.

Basic cleaning before disinfection Thorough cleaning of visible dirt, e.g. by body fluids, must be performed before the
actual disinfection.
• Cleaning may not involve sharp, pointed or abrasive objects or scouring agents or
agents containing material with abrasive effects, as this might damage the
surfaces.
Damaged surfaces can be penetrated and destroyed by chemical
substances.
• Only soft brushes and mild detergents or cleaning disinfectants may be used to
remove strong and persistent dirt. Disinfection may start after no more visible
dirt can be found.

Only use wipe-over disinfection Use the wipe-over method only for disinfection. Disinfection by UV irradiation or
steaming is not permissible.

NOTE
Warranty claim
Failure to comply with cleaning or disinfection requirements will render
any warranty claim void. No warranty is accepted for damage which is
due to the use of unsuitable cleaning agents or disinfectants.
---------------------------------------------------------------------------------------------------
The warranty applies only to undamaged surfaces!

9.1.2 Wipe-over disinfection


Wipe-over disinfection is used to disinfect the light head and the support arm system.
The light head may only be cleaned and disinfected when it is cold.

Only wipe with a damp cloth For cleaning and disinfection, wipe the device components only with a damp but not
wet cloth. Wiping should apply only a thin film of liquid and after wiping only a thin
coherent film of moisture should remain. From the microbiological point of view, this
moisture film is entirely sufficient. Liquid should not pool on the surface.

Avoid the build-up of a coating If too much liquid is applied to the surface during disinfection, residues will be left on
the product. To prevent the build-up of a coating of disinfectant residues, regular
cleaning with a mild all-purpose cleaner is necessary.
Cleaning to be carried out at least monthly The regularity of cleaning will depend on the frequency of disinfection but must be at
least once a month.
Only clean the surgical light with a damp but not wet cloth.

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9 Cleaning and disinfection

Cleaning procedure 1. Disconnect the power supply from the mains.


2. Allow the light head to cool down. Only clean or disinfect the light head when it
is cold.
3. Moisten a cloth with a drop of cleaning or disinfecting agent. Clean the surgical
light with the damp but not wet cloth.

 WARNING
Risk of fire or explosion by disinfectants
Production of gases, fumes or mists when using disinfectants
may create a combustible or explosive atmosphere.
• Do not use highly flammable disinfectants.
• Do not disinfect large areas.
• Allow hot surfaces to cool down before disinfection.
• Where possible, completely isolate the room’s electrical systems or
ensure that no switching processes – especially automatic processes
– are initiated or run whilst disinfection is in progress.
• After wipe-over disinfection, wait until the disinfectant has
completely dried.
• Ensure the room is adequately ventilated.

NOTE
Comply with national guidelines.
The operator must observe the requirements of the responsible national
hygiene and disinfection board.

9.1.3 Recommended disinfectants


Trumpf Medical recommends the following disinfectants for manual application:

Manufacturer Product designation


B. Braun Melsungen AG Meliseptol
Various 70 % 2-propanol alcohol
Schülke & Mayr GmbH Perform 0.5 %
Bode Chemie GmbH & Co. KG Dismozon pure 0.75 %
Clorox Healthcare Hydrogen peroxide cleaner disinfectant wipes
Kesla Pharma Wofasteril 0.5 %

• The list of approved disinfectants is continually updated and is given in the ‘OP
lights instruction manual as a supplement' which can be downloaded in the OIS.

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10 Sterilising handles of surgical lights

Material The handles are made of heat- and impact-resistant polyphenylene sulfone (PPSU)
plastic.

NOTE
Warranty claim
Failure to comply with the sterilisation requirements will render any
warranty claim null and void.
No warranty is accepted for damage, which is due to the use of
unsuitable sterilisation methods.
---------------------------------------------------------------------------------------
Comply with national guidelines.
The operator must observe the requirements of the responsible national
hygiene and disinfection board.

10.1 Preparation
– Remove any surface dirt on the surgical light with a disposable cloth / paper
towel.
– Remove coarse dirt from the handle immediately after use (within 2 hours).
– Store the handle for later cleaning in a container in which the dirt remains
humid.
– Avoid situations in which the inner surface of the handle is dirtied or the
cover panel is scratched.

10.2 Cleaning and disinfection


NOTE
Sterilisation faults lead to product damage
Product damage may result when the specifications and instructions
provided below are not considered or adhered to. Furthermore, it would
render any claim for damages void!
• Do not use hot-air sterilisation for handles.

10.2.1 Cleaning
The handles may be cleaned with mildly alkali cleaners without active chlorine.
Trumpf Medical recommends neodisher mediClean (forte) at a concentration of 0.5 %
(5 ml/l).
1. Pull the handle off the handle adapter.
2. Clean the handle with cleaning agent.
3. Thoroughly rinse off cleaning agents with water.

10.2.2 Disinfection
Use wipe-over or spraying as the method of disinfection. Trumpf Medical
recommends products based on alcohol or aldehyde that are approved by the
manufacturer for use on PPSU.
4. Disinfecting the handle.
5. Check the handle for material damage, cracks or deformation and exchange
damaged handles.
6. Check the cover pane (where present) for firm attachment and exchange the
handle as required.

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1 0 Sterilising handles of surgical lights

A machine-based procedure (disinfector) according to DIN EN ISO 15883-1 is to be


used for cleaning/disinfection. The effectiveness of the method used must be
accepted in principle (e.g. be included in the list of the disinfectants and procedures
checked and approved by the Robert Koch-Institute / DGHM) and must be validated
in principle.
The effectiveness of other methods used (e.g. manual methods) must be proven in
principle as part of the validation.
The Dario-D standard cleaning programme provided by the Miele company or
programmes that adhere to the following time and temperature values can in
principle be used for machine-based cleaning:

Phase Temperature Time

Pre-rinsing 20 °C 60 seconds
Cleaning 20 - 55 °C 300 seconds
Neutralisation 24 - 55 °C 60 seconds
Intermediate rinsing 20 - 24 °C 60 seconds
Disinfection 93 °C 300 seconds
Drying 100 °C 25 minutes

10.3 Sterilisation
10.3.1 General information
• The sterilisation methods must be validated in accordance with
DIN EN ISO 17665-1 and DIN EN ISO 17665-2;
• Only use fractionated pre-vacuum;
• The temperatures may not exceed 135 °C.

 WARNING
Contamination and infection hazard for patients
Check handles after sterilisation for material damage, cracks or
deformation, as detaching material particles may fall into the wounds.
• Handles that are damaged, have undergone a maximum of 350
steam sterilisation cycles or are older than 1.5 years must
immediately be exchanged.

10.3.2 Steam sterilisation


Handles may be exposed to a maximum of 350 steam sterilisation cycles without
damage when the following requirements are adhered to:
• Place the handles at an upright position with the open side pointing downwards
and ensure that the pane of the ALC or camera handles are not in direct contact
with the rinsing device (risk of scratching);
• Sterilise the handles individually in a packaging which is suitable for steam
sterilisation;
• The sterilisation packaging must be large enough for the handle, so that the seal
is not under tension;
• the maximum load of the steriliser may not be exceeded when several handles
are sterilised in one sterilisation cycle.
Steam sterilisation at 132 °C (270 °F):
• Sterilisation time = 4 minutes,
• Drying time = 20 minutes.

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1 0 Sterilising handles of surgical lights

Steam sterilisation at 135 °C (275 °F):


• Sterilisation time = 3 minutes,
• Drying time = at least 16 minutes

10.3.3 Sterilisation packaging


The handles are placed in a suitable sterilisation packaging (disposable sterilisation
packaging, e.g. film/paper sterilisation bags; single or double packaging in
accordance with DIN EN ISO 11607, suitable for steam sterilisation) and then
sterilised.
7. Place the pre-cleaned and disinfected handle in the sterilisation packaging.
8. Sterilise the handle according to the specifications.
9. Check the sterilised handle for material damage, cracks or deformation and
exchange damaged handles.
10. Check the cover pane (where present) for firm attachment and exchange the
handle as required.

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11 Inspections, maintenance and repairs

All devices are subject to wear and tear over time. The safety and function of the
device must therefore be inspected after regular inspection and maintenance
intervals. Repeat inspections must be carried out according to the specific national
regulations. Trumpf Medical recommends taking out a service contract.

Technical Customer Service


Telephone: +49 3671 586-41911
Fax: +49 3671 586-41175
[email protected]

11.1 Inspections during operation


Weekly inspection A function test and visual inspection must be performed before each use of the
lighting system in running medical operation, however at least once per week.

 WARNING
Contamination and infection hazard for patients
Loose or damaged parts may fall into wounds. To ensure the safety of
patients, check the components of the lighting system for the following
points before each use:
• loose parts in the light heads,
• visible damage, in particular on the cover plate of the light head and
the sterilisable handle,
• secure mounting of the sterilisable handle.
---------------------------------------------------------------------------------------
Defective devices
Defective devices or functional units must be clearly labelled immediately
and taken out of operation.
Contact Trumpf Medical Customer Service or an authorised service
partner in the event of damage or faults.

11.2 Annual visual inspection


Annual visual inspection A visual inspection of the hardware of the entire lighting system must be carried out
annually by the operator's qualified technicians. In the visual inspection, in particular
the following parts and components of the device must be examined for changes to
the material:
• Deformation of components of the light head and the support system,
• Paint damage on the entire support arm system and on the light heads,
• missing plastic components and small parts, e.g. covers, plugs, etc.
• cracking and brittle plastic parts,
• legibility of type labels.

Damaged or deformed components must be replaced.

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1 1 Inspections, maintenance and repairs

11.3 Maintenance every two years


Maintenance every two years The device must only be serviced by the Trumpf Medical Customer Service, or
authorised partners. The tests must be carried out every 2 years by qualified experts
in accordance with the service manual.

ATTENTION
Observe the maintenance intervals
The device must be inspected for the following points:
• Function test
• Electrical safety test

Function test In particular, the function test includes the following tests on the support arm system:
• Rotation of the support arms, adjustment of the stops; adjust as necessary;
• ease of movement of the joints; adjust as necessary;
• position of the height stops; adjust as necessary;
• attachment of the securing elements, grease as necessary;
• position and form of the securing rings on the boom and the spring arms;
• check the effect of the spring force; adjust as necessary;
• visual inspection for collision damage;
• visual inspection for cracks in the area of welds.

NOTE
Shortening of maintenance intervals
After 10 years of operation, the function test of the lighting system must
be carried out annually.
---------------------------------------------------------------------------------------
Documentation according to MPBetreibV [German regulation for
the operation of medical equipment]
According to the MPBetreibV, the performance of safety inspections as
well as service and maintenance work must be documented in a medical
product logbook.
This medical product logbook must be kept on site.

11.4 Repairs
Trumpf Medical will provide an appropriate replacement light head that can be
replaced by trained technicians, when required (e.g. when a lamp fails). Installation
of the light head is described in the installation instructions which are provided (see
Chapter: Installation of the light unit onto the support arm system).

 WARNING
Incorrect repairs
Authorised service personnel The device may only be repaired by Trumpf Medical Customer Service,
trained and qualified service staff.

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12 Adjustments

Figure 33 12.1 Setting spring arm swivel range type


AC 2000 LCH
The vertical swivel movement may only be adjusted within the
range of +30° (upwards) and -45° (downwards). The swivel
range can be set so that the collision with the ceiling or with
bordering objects can be avoided (the swivel range can be
restricted down to the horizontal level).

12.1.1 Disconnecting the power to the lighting


system
Ceiling-mounted version
1. Switch off the operating theatre master switch.
→ The lighting system is disconnected from the power
supply.
2. Secure the master switch against accidental switch-on.
Mobile stand version
1. Switch off the power supply unit, position the switch in
Position 0 (see Chapter 6.3.1, page 46), pull the mains
cable out of the safety socket.
→ The mobile lighting system is disconnected.
2. Secure the mains plug against unintentional plugging-in.

12.1.2 Setting the swivel range


Removing the covers
1. Carefully press in and unlock the four lugs ① of the two
halves of the cover ② with a suitable flat screwdriver.
2. Remove the two halves of the cover ②.

Adjusting the swivel range


3. Insert the a ached pin ④ (Ø4 mm x 110 mm) into the
hole of the adjus ng nut in the adjustment opening ③.

Reducing the swivel range


• Turn the internally arranged adjusting nut to the right
(clockwise).
Increasing the swivel range
• Turn the internally arranged adjusting nut to the left (anti-
clockwise).

Installing the covers


4. Place the halves of the cover ② on the spring arm and
press the four lugs ① against the spring arm, so that
they engage.
5. Check the firm a achment of the cover ②.
6. Carry out a function test of the swivel movement.

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1 2 Adjustments

Figure 34 12.2 Setting spring arm swivel range type


AC 2000 and type AC 3000
The vertical swivel movement may only be adjusted within the
range of +45° (upwards) and -50° (downwards). The swivel
range can be set so that the collision with the ceiling or with
bordering objects can be avoided (the swivel range can be
restricted down to the horizontal level).

12.2.1 Disconnecting the power to the lighting


system
Ceiling-mounted and wall-mounted versions
1. Switch off the operating theatre master switch.
→ The lighting system is disconnected from the power
supply.
2. Secure the master switch against accidental switch-on.

12.2.2 Setting the swivel range


1. Insert Allen key ② (5 mm) into the adjustment screw in
the adjus ng opening ①.
2. Pull down the spring arm to unload the adjustment
screw.

Reducing the swivel range


• Turn the adjustment screw to the left (anti-clockwise).
Increasing the swivel range
• Turn the adjustment screw to the right (clockwise).

3. Carry out a function test of the swivel movement.

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1 2 Adjustments

Figure 35 12.3 Setting spring arm swivel range type


AC 5000
The vertical swivel movement may only be adjusted within the
range of +40° (upwards) and -40° (downwards). The swivel
range can be set so that the collision with the ceiling or with
bordering objects can be avoided (the swivel range can be
restricted down to the horizontal level).

12.3.1 Disconnecting the power to the lighting


system
1. Switch off the operating theatre master switch.
→ The lighting system is disconnected from the power
supply.
2. Secure the master switch against accidental switch-on.

12.3.2 Removing the covers


3. Unscrew four cross sec on recess screws ②
(M4 x 6 mm) and remove both the halves of the cover
①.

12.3.3 Setting the swivel range


1. Release the retaining pin ③.
2. Pull off the securing ring ⑥ and remove the stop pins
⑦.
3. Insert stop bolts ⑦ into the required hole ④
(20° or 40°) and secure using the circlip ⑥.
4. Check for the secure fit of the circlip ⑥.

12.3.4 Installing the covers

NOTE
Positioning the cover flaps
Make sure during installation of the halves of the
cover ② that the four chrome-plated cover flaps
⑤ sit in the guides of the halves of the cover ②.

1. Insert cover flaps ⑤ in the guide of the cover halves ②.


2. Tightly screw both halves of the cover ② with four cross
sec on screws ① (M4 x 6 mm).
3. Check the firm a achment of the cover ②.
4. Carry out a function test of the swivel movement.

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1 2 Adjustments

Figure 36 12.4 Setting spring arm spring force type


AC 2000 LCH
The weight of the light head is compensated by a spring which
is installed in the spring arm. The spring force must be
adjusted when the spring arm with the light head does not
reliably stop at the height position selected after a swivel
movement.

12.4.1 Disconnecting the power to the lighting


system
Ceiling-mounted version
1. Switch off the operating theatre master switch.
→ The lighting system is disconnected from the power
supply.
2. Secure the master switch against accidental switch-on.
Mobile stand version
1. Switch off the power supply unit, position the switch in
Position 0 (see Chapter 6.3.1, page 46), pull the mains
cable out of the safety socket.
→ The mobile lighting system is disconnected.
2. Secure the mains plug against unintentional plugging-in.

12.4.2 Adjusting the spring force


1. Insert Allen key ② (5 mm) into the adjustment screw in
the adjus ng opening ①.
2. Place the spring arm in a position approx. +10° or -10° to
the horizontal in order to relieve the load on the
adjustment screw.

A: Ceiling-mounted and wall-mounted versions


Reducing the spring force
• Turn the adjustment screw to the right (clockwise).
Increasing the spring force
• Turn the adjustment screw to the left (anti-clockwise).

B: Mobile stand version


Reducing the spring force
• Turn the adjustment screw to the left (anti-clockwise).
Increasing the spring force
• Turn the adjustment screw to the right (clockwise).

3. Carry out a function test of the spring force.

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1 2 Adjustments

Figure 37 12.5 Setting spring arm spring force type


AC 2000 and type AC 3000
The weight of the light head is compensated by a spring which
is installed in the spring arm. The spring force must be
adjusted when the spring arm with the light head does not
reliably stop at the height position selected after a swivel
movement.

12.5.1 Disconnecting the power to the lighting


system
Ceiling-mounted and wall-mounted versions
1. Switch off the operating theatre master switch.
→ The lighting system is disconnected from the power
supply.
2. Secure the master switch against accidental switch-on.

12.5.2 Adjusting the spring force


1. Place the spring arm in a position approx. +10° to the
horizontal in order to relieve the load on the adjustment
screw.
2. Turn the M5 threaded pin with Allen key ② (5 mm) in
adjustment hole ①.

Reducing the spring force


• Turn the adjustment screw to the left (anti-clockwise).
Increasing the spring force
• Turn the adjustment screw to the right (clockwise).

3. Carry out a function test of the spring force.

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1 2 Adjustments

Figure 38 12.6 Setting the spring arm spring force type


AC 5000
The weight of the light head is compensated by a spring which
is installed in the spring arm. The spring force must be
adjusted when the spring arm with the light head does not
reliably stop at the height position selected after a swivel
movement.

12.6.1 Disconnecting the power to the lighting


system
Ceiling-mounted version
1. Switch off the operating theatre master switch.
→ The lighting system is disconnected from the power
supply.
2. Secure the master switch against accidental switch-on.

12.6.2 Adjusting the spring force


1. Place the spring arm in a position approx. +10° to the
horizontal in order to relieve the load on the adjustment
screw.
2. Turn the M6 threaded pin with Allen key ② (6 mm) in
adjustment hole ①.

Reducing the spring force


• Turn the adjustment screw to the left (anti-clockwise).
Increasing the spring force
• Turn the adjustment screw to the right (clockwise).

3. Carry out a function test of the spring force.

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1 2 Adjustments

Figure 39 12.7 Adjusting the brake force of the friction


brakes
If the boom, spring arm, convenience bracket or the light head
do not remain stable in the position to which they are rotated,
the braking force of the friction brake must be adjusted.
The friction brake acts through the friction force of the
adjustment screw (slot-head screw (3)) on the relevant pin of
the support arm components.
If the braking force of several support arm components needs
to be adjusted, the brakes must be adjusted in the following
sequence:
1. Friction brake A for boom;
2. Friction brakes B for spring arm;
3. Friction brake C for convenience bracket;
4. Friction brake D and E for the cardan joint light head;

ATTENTION
Screw types for the friction brakes
The brake screws are slot-head screws:
All other types of screw must not be loosened.

12.7.1 Disconnecting the power to the lighting


system
Ceiling-mounted and wall-mounted versions
1. Switch off the operating theatre master switch.
→ The lighting system is disconnected from the power
supply.
2. Secure the master switch against accidental switch-on.
Mobile stand version
1. Switch off the power supply unit, position the switch in
Position 0 (see Chapter 6.3.1, page 46), pull the mains
cable out of the safety socket.
→ The mobile lighting system is disconnected.
2. Secure the mains plug against unintentional plugging-in.

12.7.2 Adjusting the braking force for the boom


Adjusting friction brake A:
1. Adjust brake screw ① with a suitable slot-head
screwdriver:

Reducing the braking force


• Turn the adjustment screw to the left (anti-clockwise).
Increasing the braking force
• Turn the adjustment screw to the right (clockwise).

2. Carry out a function test of the braking force.

Brake screw type: 1378864

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1 2 Adjustments

Figure 40 12.7.3 Adjusting the braking force for the spring arm
Adjusting friction brake B:
1. Adjust brake screw ① with a suitable slot-head
screwdriver:

Reducing the braking force


• Turn the adjustment screw to the left (anti-clockwise).
Increasing the braking force
• Turn the adjustment screw to the right (clockwise).

2. Carry out a function test of the braking force.

Brake screw type: 1378857

12.7.4 Adjusting the brake of the convenience


bracket on AC 3000
The braking force for the convenience bracket is only adjusted
on the AC 3000 spring arm. Adjusting friction brake C:
1. Adjust brake screw ② with a suitable slot-head
screwdriver:

Reducing the braking force


• Turn the adjustment screw to the left (anti-clockwise).
Increasing the braking force
• Turn the adjustment screw to the right (clockwise).

2. Carry out a function test of the braking force.

Brake screw type: 1378868

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1 2 Adjustments

Figure 41 12.7.5 Adjusting the brake force of the cardan joint


rod
Light head on the convenience bracket
Adjusting the friction brake D of the light head on the
convenience bracket:
1. Adjust brake screw ① with a suitable slot-head
screwdriver:

Reducing the braking force


• Turn the adjustment screw to the left (anti-clockwise).
Increasing the braking force
• Turn the adjustment screw to the right (clockwise).

2. Carry out a function test of the braking force.

Brake screw type: 4025239


Figure 42 Light head on AC 2000 LCH spring arm
Adjusting the friction brake D for the light head on AC 2000
LCH spring arm:

Removing the covers


1. Carefully press in and unlock the four lugs ① of the two
halves of the cover ② with a suitable flat screwdriver.
2. Remove the two halves of the cover ②.

Adjusting the braking force


1. Adjust brake screw ③ with a suitable slot-head
screwdriver on both sides:

Reducing the braking force


• Turn the adjustment screw to the left (anti-clockwise).
Increasing the braking force
• Turn the adjustment screw to the right (clockwise).

2. Carry out a function test of the braking force.

Installing the covers


3. Place the halves of the cover ② on the spring arm and
press the four lugs ① against the spring arm, so that
they engage.
4. Check the firm a achment of the cover ②.

Brake screw type: 1378866

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1 2 Adjustments

Figure 43 12.7.6 Setting the braking force of the cardan joint


axle on the standard light head
Adjusting the friction brake E for the light head on the handle
attachment. If the friction brake can no longer be adjusted, an
internal brake strip must be replaced by a service technician.
1. Pull the sterile handle ① off the handle adapter.
2. Unscrew the four Allen screws ⑥ (M4 x 30 mm) and
remove the handle a achment ⑤.
3. Remove cover of the handle a achment ④.
4. Evenly turn the two M6 threaded pins with Allen key ③
(6 mm) in adjustment hole ②.

Reducing the braking force


• Turn the adjustment screw to the left (anti-clockwise).
Increasing the braking force
• Turn the adjustment screw to the right (clockwise).

5. Put on the cover of the handle a achment ④. Put on


the handle a achment ⑤ and fasten it with the four
Allen screws ⑥.
6. Check the firm attachment of the components.
7. Put the sterile handle ① on the handle adapter.
8. Carry out a function test of the braking force.

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1 2 Adjustments

Figure 44 12.7.7 Setting the braking force on the light head


SLC / ALC plus
Adjusting the friction brake E for the light head on the handle
attachment. If the friction brake can no longer be adjusted, an
internal brake strip must be replaced by a service technician.
1. Pull the sterile handle ① off the handle adapter.
2. Unscrew the four Allen screws ⑥ (M4 x 15 mm).
3. Remove the securing ring ⑤.
4. Remove cover of the handle a achment ④.
5. Evenly turn the two M6 threaded pins with Allen key ③
(6 mm) in adjustment hole ②.

Reducing the braking force


• Turn the adjustment screw to the left (anti-clockwise).
Increasing the braking force
• Turn the adjustment screw to the right (clockwise).

6. Put on the cover of the handle a achment ④.


7. Put on the securing ring ⑤.
8. Fasten the securing ring with the four Allen screws ⑥.
9. Check the firm attachment of the components.
10. Put the sterile handle ① on the handle adapter.
11. Carry out a function test of the braking force.

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1 2 Adjustments

Figure 45 12.7.8 Setting the cardan joint axis braking force on


the standard light head with camera
Adjusting the friction brake E for the light head on the handle
attachment. If the friction brake can no longer be adjusted, an
internal brake strip must be replaced by a service technician.
1. Pull the sterile handle ① off the camera.
2. Remove camera ② from camera mount ③ (See
TruVidia SD/HD/3D instruction manual).
3. Unscrew the four countersunk screws with cross-heads
⑧ and remove the cover of handle a achment ⑦.
4. Evenly turn the M6 threaded pins with Allen key ⑥
(6 mm) in adjustment hole ⑤.

Reducing the braking force


• Turn the adjustment screw to the left (anti-clockwise).
Increasing the braking force
• Turn the adjustment screw to the right (clockwise).

5. Put on handle a achment cover ⑦ and screw in the


four countersunk screws with cross-heads ⑧.
6. Check the firm fastening of handle a achment cover ⑦.
7. First couple on camera ③ and then put the sterile
handle ① on the camera.
8. Carry out a function test of the braking force.

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13 Consumables

Handles and brake screws

Handles Chapter #
Sterilisable handle for light head; Chpt. 8.4 0337642
Plastic (pack of 3)
Sterilisable handle for camera; Instruction manual 0337643
Plastic (pack of 3) TruVidia SD/HD/3D
Sterilisable handle for Adaptive Light Chpt. 8.4 1612088
Control plus; (pack of 3)
Brake screws Chapter #
Brake screw with slot on AC 3000 type Chpt. 12.7.4 1378868
spring arm;
M10 x 1 mm with 9 mm length (2 units)
Brake screw with slot at the spring arm Chpt. 12.7.5 1378866
type AC 2000 LCH (Low Ceiling Height);
M12 x 1 mm with 21 mm length (2 units)
Brake screw with slot at the boom Chpt. 12.7.2 1378864
(brake of the boom);
M12 x 1 mm with 30 mm length (2 units)
Brake screw with slot at the boom Chpt. 12.7.3 1378857
(brake of the spring arm);
M12 x 1 mm with 16 mm length (2 units)
Brake screw with slot at the Chpt. 12.7.5 4025239
convenience bracket;
M10 x 1 mm with 11 mm length (2 units)
Brake cleat with M6 threaded pins with Replacement by service technician only 1506935
12 mm length on light head (2x); (light
head brake)

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14 Troubleshooting

NOTE
Recurrent faults
If a fault reoccurs or cannot be remedied, put the device out of service and contact Trumpf Medical Customer
Service.
Causes of faults and fault removal

Error Possible cause Remedy Chapter


Suspension / mobility
Light head drops / rises Spring force in spring arm is Adjusting the spring force Chpt. 12.4 - Chpt. 12.6
too strong / too weak
Light head moves Brakes too stiff / too loose Adjust brakes Chpt. 12.7.2 - Chpt. 12.7.5
with difficulty / easily
Optical system / light technology
Light intensity too low Light intensity set too low Increase light intensity Chpt. 8.9
Inhomogeneous light field The light head is outside the Position the light head Chpt. 8.6
working area
The light does not light Main switch in the operating Switch on the main switch Chpt. 8.6
theatre is switched off
Light head has been turned Press the ON / OFF button Chpt. 8.6
off at the control panel
Mains cable of the mobile Plug mains cable into socket Chpt. 8.6
stand version not plugged in
Power unit of the mobile Press the ON / OFF button on Chpt. 8.6
stand version not switched the power supply housing
on
Defective electronics Inform Trumpf Medical —
Customer Service
Site power supply is Check site fuses and power —
interrupted supply
Automatic distance Software failure Deactivate ALC plus and Chpt. 8.9.3
measurement is not working manually select the distance
(ALC plus display is flashing) or disconnect from power
supply and then reconnect
Different colour Colour temperature is set on Switch on the SYNC function Chpt. 8.9.6
temperatures in the light only one light head
field
Sterilisable handle
Handles are damaged or End of service life has been Replace handles Chpt. 8.4
show cracks reached
Life span of the sterilisable Wrong sterilisation method Check sterilisation method Chpt. 11
handles too short

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15 Technical data

15.1 Equipment versions for the light models


TruLight 3000 equipment versions

Product designation TruLight 3300 TruLight 3500 TruLight 3510


Adaptive Light Control (ALC) 3 3 3
Camera — — 3
Outer handles not illuminated 3 3 3
Wall-mounted control panel Optional Optional Optional

TruLight 5000 equipment versions

Product designation TruLight TruLight TruLight TruLight TruLight TruLight


5300 5310 5320 5500 5510 5520
Adaptive Light Control (ALC) 3 3 3 3 3 3
Sterile Light Control (SLC) — — 3 — — 3
Adaptive Light Control Plus (ALC plus) — 3 3 — 3 3
Camera — 3 — — 3 —
Outer handles illuminated 3 3 3 3 3 3
Wall-mounted control panel Optional Optional Optional Optional Optional Optional
Colour temperature can be set on control panel Optional Optional Optional Optional Optional Optional

15.2 Device data


TruLight 3000 electrical data

Electrical data TruLight 3300 TruLight 3500 TruLight 3510


Mains adapter supply voltage 100 - 240 VAC 100 - 240 VAC 100 - 240 VAC
50/60 Hz 50/60 Hz 50/60 Hz
Supply voltage at the DC-DC converter 19 - 36 V DC 19 - 36 V DC 19 - 36 V DC
21.6–26.4 V AC 21.6–26.4 V AC 21.6–26.4 V AC
Light head power uptake 65 VA
(160,000 lux at a distance of 1.0 m)
Max. power uptake of total system 130 VA 150 VA
Internal fuse (mobile stand version only) 2 x T10 A
Voltage at fixed point on ceiling 48 V
Average Service Life of Light Source (LED) > 60,000 hrs
Classification according to MPG 1 1 1

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1 5 Technical data

TruLight 5000 electrical data

Electrical data TruLight 5300 TruLight 53x0 TruLight 5500 TruLight 55x0
Mains adapter supply voltage 100 - 240 VAC 100 - 240 VAC 100 - 240 VAC 100 - 240 VAC
50/60 Hz 50/60 Hz 50/60 Hz 50/60 Hz
Supply voltage at the DC-DC converter 19 - 36 V DC 19 - 36 V DC 19 - 36 V DC 19 - 36 V DC
21.6–26.4 V AC 21.6–26.4 V AC 21.6–26.4 V AC 21.6–26.4 V AC
Light head power uptake 65 VA
(160,000 lux at a distance of 1.0 m)
Max. power uptake of total system 110 VA 140 VA 120 VA 160 VA
Internal fuse (mobile stand version only) 2 x T10 A
Voltage at fixed point on ceiling 48 V
Average Service Life of Light Source (LED) > 60,000 hrs
Classification according to MPG 1 1 1 1

TruLight 3000 lighting system technical data

Product designation TruLight 33x0 TruLight 35x0


Light intensity at 1.0 m 140,000 lux 160,000 lux
Dimmable from/to < 10% Endo; < 10% Endo;
40%–100% 40%–100%
Variable light field size due to changes in distance 17 - 25 cm 17 - 25 cm
Light field diameter (d10) at 1.0 m 18 cm 18 cm
Light field diameter (d50) at 1.0 m 9.4 cm 9.5 cm
d50/d10 ratio 0.52 0.53
Radiant power (W/m)*: 587 616
Residual light intensity with 1 switch 81,200 lux 108,800 lux
58% 68%
Residual light intensity with 2 switches 61,600 lux 75,200 lux
44% 47%
Residual light intensity with tube 140,000 lux 155,200 lux
100% 97%
Residual light intensity with tube and 1 switch 81,200 lux 104,000 lux
58% 65%
Residual light intensity with tube and 2 switches 61,600 lux 72,000 lux
44% 45%
Illumination depth (L1 + L2) at 20% 83 cm 75 cm
Ec / EN ISO 60601-2-41 2nd Edition
Illumination depth (L1 + L2) at 60% 44 cm 41 cm
Ec / EN ISO 60601-2-41 3rd Edition
Colour rendering index Ra 94 93
Colour temperature 4.500 K

* = at a distance of 0.9 m

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1 5 Technical data

TruLight 5000 lighting system technical data

Product designation TruLight 53x0 TruLight 55x0


Light intensity at 1.0 m 140,000 lux 160,000 lux
Dimmable from/to < 10% Endo; < 10 % Endo;
40 %–100 % 40 %–100 %
Variable light field size due to changes 16 cm - 30 cm 16 cm - 30 cm
in distance
Radiant power (W/m)*: 620 676
Narrow light field Wide light field Narrow light field Wide light field
(optional) (optional)
Light field diameter (d10) at 1.0 m 16 cm 23 cm 16 cm 23 cm
Light field diameter (d50) at 1.0 m 9.6 cm 12 cm 9 cm 11 cm
d50/d10 ratio 0.60 0.52 0.56 0.48
Residual light intensity with 1 mask 40,600 lux 81,200 lux 94,400 lux 121,600 lux
29 % 58 % 59 % 76 %
Residual light intensity with 2 masks 57,400 lux 60,200 lux 68,800 lux 78,400 lux
41% 43% 43 % 49 %
Residual light intensity with tube 140,000 lux 140,000 lux 156,800 lux 150,400 lux
100 % 100% 98 % 94 %
Residual light intensity with tube and 40,600 lux 81,200 lux 92,800 lux 112,000 lux
1 switch 29 % 58% 58 % 70 %
Residual light intensity with tube and 57,400 lux 60,200 lux 68,800 lux 72,000 lux
2 switches 41 % 43% 43 % 4 5%
Illumination depth (L1 + L2) at 20% EC / 94 cm 96 cm 95 cm 94 cm
EN ISO 60601-2-41 2nd edition
Illumination depth (L1 + L2) at 60% EC / 51 cm 51 cm 60 cm 60 cm
EN ISO 60601-2-41 3rd edition
Colour rendering index (Ra) max. 96 max. 96
Colour temperature (settable during 3,500 K, 4,000 K, 4,500 K, 5,000 K
initial installation)
Colour temperature (can be set on Optional Optional
control panel)

* = at a distance of 0.9 m

Mechanical data, light models 3000

Mechanical data TruLight 33x0 TruLight 35x0


Light head diameter 640 mm 730 mm
2
Distribution area of the light head 2100 cm 3100 cm2
Light-emitting surface area 1332 cm2 1892 cm2
Weight of the light heads (incl. convenience and central bracket) 12.9 kg 17.2 kg

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1 5 Technical data

Mechanical data, 5xxxx light models

Mechanical data TruLight 53x0 TruLight 55x0


Light head diameter 640 mm 730 mm
2
Distribution area of the light head 2100 cm 3100 cm2
Light-emitting surface area 1332 cm2 1892 cm2
Weight of the light heads (incl. convenience and central bracket) 13.9 kg 17.2 kg

Performance specifications, Laser 5520/5320

Performance specifications TruLight 5520 TruLight 5320


Max. output power 0.95 mW 0.95 mW
Wavelength 620-690 nm 620-690 nm
Beam divergence 0.16 x 0.6 mRad 0.16 x 0.6 mRad
Pulse duration 0.4 x 10 ^ -9 s 0.4 x 10 ^ -9 s
Pulse refresh rate 320 MHz 320 MHz

Sensor marking: identifies the class of the laser product installed for distance meas-
urement according to IEC 60825-1, Edition 2 (2007-03) and IEC 60825-1,
Edition 3 (2014).

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1 5 Technical data

15.3 EMC information


EMC notes

 WARNING
Operate the device only with the stated accessories.
The device may only be operated with the accessories stated in the accompanying documents. Operation with
accessories, converters or cables other than those stated in the accompanying documents can lead to increased
EMC emissions or reduced interference immunity of the device and with it to improper use.

Using the device


Use of the device directly adjacent to other devices or stacked with other devices should be avoided, as this can
result in faulty operation. If this form of use is, however, necessary, this device and the other devices should be
monitored to ensure they are working properly.

The lighting system is intended for use in the environment specified below. The customer or user of the device should ensure
that it is operated in one of the environments as described.

Essential characteristics:
The key performance characteristics are the supply of illumination and the limiting of energy in the surgical area.

Measurement of interfering Compliance Comments


emissions
RF emissions in accordance with CISPR Group 1 The lighting system uses RF energy exclusively for its
11 internal FUNCTION. Therefore, its' RF emission is very low
and it is very unlikely that neighbouring devices are
disturbed.
RF emissions in accordance with CISPR 11 Class A The TruLight lighting system is suitable for use in
establishments other than domestic and those connected
Harmonic Emissions as per IEC 61000-3-2 Class A
directly to the PUBLIC LOW-VOLTAGE NETWORK that
Harmonic emissions from voltage In compliance supplies buildings used for domestic purposes, providing
fluctuations and flicker emissions as per the following warning is observed:
IEC 61000-3-3 REMARK
The properties of this device determined by its
EMISSIONS allows its use in industrial fields and in
hospitals (CISPR 11, Class A). If used in a domestic setting
(for which Class B is generally required in accordance with
CISPR 11), this device may cause radio interference. The
user may be required to take adequate measures, such as
conversion or realignment of the device.

The recommendations in the instruction manual to preserve BASELINE SAFETY and ESSENTIAL PERFORMANCE PROPERTIES of
the devices during its entire operating life must be observed. See Chapter 11 "Inspections, maintenance and repairs".

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1 5 Technical data

Guidelines and manufacturer's declaration - electromagnetic immunity


The lighting system is intended for use in the environment specified below. The customer or user of the device should ensure
that it is operated in one of the environments as described. The support arm system may not execute any unintentional
movements in cases of interference. Important EMC characteristics of the lighting systems:

Error/immunity test IEC 60601 test level Compliance level Environment / guidelines
Electrostatic discharge (ESD) ±8 kV contact ±8 kV contact discharge Flooring should be made of wood or
according to discharge ±15 kV air discharge concrete or have ceramic tiles. If the floor
IEC 61000-4-2 ±15 kV air discharge is made with synthetic material, the
relative humidity must amount to at least
30 %.
Rapid transient electrical ±2 kV for mains cables ±2 kV for mains cables Mains power quality should be that of a
interference variables/bursts ±1 kV for input and ±1 kV for input and typical commercial or hospital
as per IEC 61000-4-4 output cables output cables environment.
100 kHz repetition rate 100 kHz repetition rate
Surges as per IEC 61000-4-5 ±1 kV outer conductor ±1 kV outer conductor - Mains power quality should be that of a
- outer conductor outer conductor voltage typical commercial or hospital
voltage ±2 kV outer conductor – environment.
±2 kV outer conductor ground wire
– ground wire
Voltage dips, short 0 % UT; 0.5 cycle at 0°, 0 % UT; 0.5 cycle at 0°, Mains power quality should be that of a
interruptions and voltage 45°, 90°, 135°, 180°, 45°, 90°, 135°, 180°, 225°, typical commercial or hospital
fluctuations of power supply 225°, 270° and 315° 270° and 315° environment. If the user of the lighting
as per IEC 61000-4-11 0 % UT; 1 cycle 0 % UT; 1 cycle system requires continued functioning
70 % UT; 25/30 cycles 70 % UT; 25/30 cycles at 0° even during power supply interruptions,
at 0° and 180° and 180° it is recommended that the lighting
0 % UT; 250/300 cycle 0 % UT; 250/300 cycle system be supplied from an
uninterruptible power source or
Note: Note: battery.
UT is the AC mains UT is the AC mains
voltage voltage
prior to applying the prior to applying the test
test level. level.
Magnetic field with a supply 30 A/m 30 A/m Magnetic fields for the network
frequency (50/60 Hz) as per frequency should comply with values
IEC 61000-4-8 commonly found in commercial and
hospital environments.

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1 5 Technical data

Guidelines and manufacturer declaration - immunity to electromagnetic


interference / portable and mobile radio devices
Portable and mobile RF communication device should be used no closer to any part of the insulating lighting system, including
cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended safety distance:

Immunity test IEC 60601 test level Compliance level Environment / guidelines
Conducted RF noise as per 3V 3V D = 1, 2 P
IEC 61000-4-6 0.15 MHz – 80 MHz 0.15 MHz – 80 MHz
6V 6V
in the ISM band between in the ISM band between
0.15 MHz and 80 MHz a 0.15 MHz and 80 MHz a
Conducted RF noise as per 3 V/m 3 V/m D = 1, 2 P at:
IEC 61000-4-3 80 MHz – 2.7 GHz 80 MHz – 2.7 GHz 80 MHz to 800 MHz *
(see special frequencies (see special frequencies D = 2, 3 P at
table) table) 800 MHz to 2.7 GHz *
a
= The ISM radio bands (ISM = industrial, scientific and medical) between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795
MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz. The amateur radio frequencies
between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz; 3.5 MHz to 4.0 MHz; 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1
MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 8.0 MHz
to 29.7 MHz and 50.0 MHz to 54.0 MHz.

*With P as the rated output of the transmitter in watt (W) according to the details of the transmitter manufacturer and D as the
recommended safety distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic
site surveya, should be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol:
Explanation of a and b:
a
Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcasting and TV broadcasting cannot be predicted theoretically with accuracy. In order to
determine the electro-magnetic environment with regard to the fixed transmitter, a study of the location should be considered.
If the measured field strength at the location where the aforementioned devices are being used exceeds the compliance level
given above, the lighting system should be kept under observation. Additional measures may be necessary, such as a changed
orientation or a different location.
b
The field strength should be lower than 3 V/m in the frequency range of 150 kHz to 80 MHz.
Notes:
At 80 MHz and 800 MHz, the higher value applies.
These guidelines may not be applicable in all cases. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.

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1 5 Technical data

Immunity level of RF fields from wireless communication device


Table: Special frequencies

Test Band Service Modulation max. Distance Immunity


Frequenc (MHz) power (m) level (V/
y (MHz) (W) m)
385 380 – 390 TETRA 400 Pulse modulation 18 Hz 1.8 0.3 26
450 430 – 470 GMRS 460 Pulse modulation FM ±5 2 0.3 28
FRS 460 kHz variation, 1 kHz sine
720 704 – 787 LTE band 13, 17 Pulse modulation 217 Hz 0.2 0.3 9
745
780
810 800 – 960 GSM 800/900 Pulse modulation 18 Hz 2 0.3 28
TETRA 800
870
iDEN 820
930 CDMA 850
LTE band 5
1720 1700 – GSM 1800 Pulse modulation 217 Hz 2 0.3 28
1990 CDMA 1900
1845
GSM 1900
1970 DECT
LTE band 1, 3, 4, 25
UMTS
2450 2400 – Bluetooth Pulse modulation 217 Hz 2 0.3 28
2570 WLAN
802.11 b/g/n
RFID 2450
LTE band 7
5240 5100 – WLAN 802.11 a/n Pulse modulation 217 Hz 0.2 0.3 9
5800
5500
5785

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1 5 Technical data

Controlled RF interference variables


The lighting system is intended for use in an electromagnetic environment where the RF disturbances are monitored. To prevent
electromagnetic interference, maintain a minimum distance between the portable and mobile HF communications devices
(transmitters) and the above-mentioned device according to the maximum output power of the communications equipment, as
recommended below.

Rated output of Safety distance for the transmission frequency


transmitter/W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
D = 1, 2 P D = 1, 2 P D = 2, 3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

For transmitters, whose maximum rated output is not indicated in the table above, the recommended safety distance D in
metres (m) can be determined using the equation, which belongs to the respective column, whereby P is the maximum rated
output of the transmitter in watts (W) according to the information of the transmitter manufacturer.

Notes:
At 80 MHz and 800 Hz, the higher frequency range applies. These guidelines may not be applicable in all cases. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and people.

 WARNING
Distance for portable RF communication device and their peripherals
Do not use portable RF communication device (including peripherals such as antenna cables and external antenna)
at a distance below 30 cm (12 inch) to the lighting system including its cables specified by the manufacturer. This
can otherwise lead to a decline in the functionality of the system.

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1 5 Technical data

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55000-00011_002_01 – 1756789 – 2017-09-06

TRUMPF Medizin Systeme GmbH + Co. KG


Carl-Zeiss-Straße 7-9
D-07318 Saalfeld
Telefon: +49 3671 586-0
Telefax: +49 3671 586-41165
E-Mail: [email protected]
www.trumpfmedical.com

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