Hillrom Trumpf Medical TruLight 1000 User manual

Instruction manual
TruLight™ 1000 examination light
Read the instruction manual before using the product and store for later reference.
English
en-EN

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Thank you very much
for buying the new TruLight™ 1000 lighting system. Please read through this
instruction manual very carefully and ensure adherence to all safety instructions and
requirements regarding the operation and care of the device.
This instruction manual applies to the following components:
Device versions TruLight™ 1000 lighting system:
• Version with light head as ceiling-mounted version.
• Version with light head as wall-mounted version.
• Version with light head as mobile pedestal version.
• Version with a light head on TRUMPF Medizin Systeme GmbH + Co. KG
ceiling-mounted supply unit.

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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
Telephone: [phone]
Fax: [phone]
[e-mail]
www.trumpfmedical.com
Trumpf Medical will hereinafter be used as a synonym for TRUMPF Medizin Systeme
GmbH + Co. KG to improve readability.
Technical Customer Service The contact data for the current sites of the technical customer service in the
individual countries are provided on the Internet at www.trumpfmedical.com.
In the following, technical Customer Service will be used as a synonym for
Trumpf Medical Customer Service and for technicians of service operators authorised
and trained by Trumpf Medical.

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Notes relating to this documentation
Original instruction manual on CD This instruction manual is available in PDF format on the Trumpf Medical CD provided
with the system. Please contact the technical customer service if you require a
replacement CD.
Keep the instruction manual stored safely
near the system
A printed version of the user manual should be kept easily accessible and near the
system for reference purposes.
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.
TruLight™ is a registered trademark of TRUMPF GmbH + Co. KG.
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.
• The German instruction manual is the original instruction manual.
Translations • The German-language version of this instruction manual shall be binding as
regards translations into foreign languages.

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Table of contents
1 Important information regarding safe use..................................................................... 9
1.1 Details for identification of the device..............................................................................................................9
1.2 Details for identification of the instruction manual..........................................................................................9
1.3 Designation of groups of individuals.................................................................................................................9
1.3.1 Operator ...............................................................................................................................................................................9
1.3.2 User.......................................................................................................................................................................................9
1.3.3 Specialised staff ....................................................................................................................................................................9
1.4 Information for operators...............................................................................................................................10
1.4.1 Initial commissioning ..........................................................................................................................................................10
1.4.2 Availability of the instruction manual.................................................................................................................................10
1.4.3 Exclusion of liability ............................................................................................................................................................10
1.4.4 Maintenance and repair .....................................................................................................................................................10
1.4.5 Service life of the device.....................................................................................................................................................10
1.4.6 Date of manufacture...........................................................................................................................................................11
1.5 Delivery ...........................................................................................................................................................11
1.5.1 Transportation damage ......................................................................................................................................................11
1.5.2 Return address....................................................................................................................................................................11
1.6 Information for users ......................................................................................................................................11
1.6.1 Training on the device ........................................................................................................................................................12
1.6.2 Obligation of the user to inform and to inspect .................................................................................................................12
1.7 Conformity ......................................................................................................................................................12
1.7.1 Identification.......................................................................................................................................................................12
1.7.2 Standards and directives.....................................................................................................................................................12
1.7.3 Proper use...........................................................................................................................................................................13
1.7.4 Special features...................................................................................................................................................................13
1.7.5 Improper use.......................................................................................................................................................................13
1.8 Ambient conditions for operation and storage ..............................................................................................13
1.8.1 Ambient conditions for operation ......................................................................................................................................14
1.8.2 Ambient conditions for storage..........................................................................................................................................14
1.9 Combination with other medical devices .......................................................................................................14
1.10 Disposal...........................................................................................................................................................14
2 Safety instructions..................................................................................................... 15
2.1 Structure of the safety instructions in this user manual.................................................................................15
2.1.1 Indicating risk of injury .......................................................................................................................................................15
2.1.2 Indicating damage to property ...........................................................................................................................................15
2.1.3 Indicating additional information .......................................................................................................................................15
2.2 Additional symbols for the safety information ...............................................................................................15
2.3 Symbols on the device ....................................................................................................................................16
2.4 Overview of the most important safety instructions......................................................................................16
3 The technology of the lighting system......................................................................... 20
3.1 The light head .................................................................................................................................................20
3.2 The LED light source........................................................................................................................................20
4 Identification of the lighting system ........................................................................... 21
4.1 Use of serial numbers and device labels.........................................................................................................21
4.1.1 Markings on the ceiling-mounted version..........................................................................................................................21
4.1.2 Markings on the wall-mounted version..............................................................................................................................21
4.1.3 Markings on the mobile stand version ...............................................................................................................................22
5 Description of devices and functions........................................................................... 23
5.1 Description of the ceiling-mounted version ................................................................................................... 23

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5.2 Functional description of the support arm system, ceiling version................................................................24
5.3 Description of the wall-mounted version .......................................................................................................25
5.4 Functional description of the support arm system, wall-mounted version....................................................26
5.5 Description of mobile stand version ...............................................................................................................27
5.6 Functional description of the support arm system, mobile stand version .....................................................28
6 Commissioning .......................................................................................................... 29
6.1 Checking the lighting system ..........................................................................................................................29
6.1.1 Danger of pinching when positioning the lighting system..................................................................................................30
6.1.2 Risks of collision during positioning....................................................................................................................................30
6.1.3 Positioning the cover-mounted/wall-mounted version .....................................................................................................31
6.1.4 Power supply of wall-mounted version cable connection..................................................................................................32
6.1.5 Positioning the mobile stand version .................................................................................................................................33
6.1.6 Power supply of the mobile stand version .........................................................................................................................34
7 Operation.................................................................................................................. 35
7.1 Working rules..................................................................................................................................................35
7.2 Preparatory measures.....................................................................................................................................35
7.3 Measures to take when using the lighting system..........................................................................................36
7.4 Attaching / removing the sterilisable handle..................................................................................................37
7.5 Positioning the light head ...............................................................................................................................37
7.6 Switching the light head on / off.....................................................................................................................38
7.7 Setting the light intensity................................................................................................................................38
8 Cleaning and disinfection ........................................................................................... 39
8.1 Cleaning and disinfection................................................................................................................................40
8.1.1 General ...............................................................................................................................................................................40
8.1.2 Wipe-over disinfection .......................................................................................................................................................40
8.1.3 Recommended disinfectants ..............................................................................................................................................41
9 Sterilisation............................................................................................................... 42
9.1 Preparation .....................................................................................................................................................42
9.2 Cleaning and disinfection................................................................................................................................42
9.2.1 Cleaning ..............................................................................................................................................................................42
9.2.2 Disinfection.........................................................................................................................................................................42
9.3 Sterilising handles for examination lights .......................................................................................................43
9.3.1 Preparation .........................................................................................................................................................................43
9.3.2 Cleaning and disinfection....................................................................................................................................................44
9.3.3 Sterilisation .........................................................................................................................................................................44
9.3.4 Sterilisation packaging ........................................................................................................................................................45
10 Inspections, maintenance and repairs......................................................................... 46
10.1 Inspections during operation..........................................................................................................................46
10.2 Annual visual inspection .................................................................................................................................46
10.3 Maintenance every two years.........................................................................................................................46
10.4 Repairs ............................................................................................................................................................47
11 Adjustments .............................................................................................................. 48
11.1 Specifications ..................................................................................................................................................48
11.2 Adjusting the spring force on the spring arm .................................................................................................48
11.3 Adjusting the brake force of the quarter bracket...........................................................................................49

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12 Wearing parts............................................................................................................ 50
13 Troubleshooting ........................................................................................................ 51
14 Technical data ........................................................................................................... 52
14.1 Device data .....................................................................................................................................................52
14.2 EMC information.............................................................................................................................................53

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1 Important information regarding safe use
1.1 Details for identification of the device
This instruction manual is solely intended for devices with device labels that show the
following information:
Device identification
1.2 Details for identification of the instruction manual
Up-to-dateness of this user 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.: 1695233
– Date of publication: 25/01/2018
– Document number: 55000-00012_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 user 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 appropriate training by
specialised staff, are authorised to operate and work with the device.
• Users are fully responsible for the safe application of the device for the intended
purpose.
1.3.3 Specialised staff
Specialised staff means authorised individuals, who are generally employed by the
operator. They must
• have undertaken a course of technical training in the medical technology field,
• be able to use their professional experience and training regarding safety
regulations to assess the work they perform and recognise potential hazards
involved in that work.
• must have the appropriate certification to be classified as 'specialist personnel’
(e.g. by Trumpf Medical certified medical technicians or Trumpf Medical sales
employees) in countries requiring certification of personnel performing work in
the medical technology field.
Descriptor / rating Type Material no.
TruLight™ 1000 TruLight™ 1000 pre-assembly set 4058051
TruLight™ 1000 TruLight™ 1000 ceiling 4058110
TruLight™ 1000 TruLight™ 1000 wall 4058120
TruLight™ 1000 TruLight™ 1000 mobile [phone]
TruLight™ 1000 TruLight™ 1000 pendant 4058140

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1.4 Information for operators
Procedural guidelines The device has been manufactured with state-of-the-art technology and is
operationally safe.
• The device can nevertheless be a source of danger, especially when it is operated
by inadequately trained personnel or used incorrectly or for an unintended
purpose.
• The device may only be operated, cleaned, disinfected and maintained by users
that were trained by specialised staff.
1.4.1 Initial commissioning
Validity This instruction manual is only valid after successful initial operation by an installer
authorised by the manufacturer.
• A full electrical safety test is required before initial commissioning.
• The operator must be instructed in the operation of the lighting system in
accordance with the applicable instruction manual.
• Prior to being used for the first time, the device must be thoroughly cleaned and
disinfected.
• 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 Exclusion of liability
Exclusion of liability The warranty for the product by Trumpf Medical requires that:
• the device is exclusively used for the proper use 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 design 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:
• Technical customer service,
• authorised service companies trained by Trumpf Medical,
• the operator's service personnel when trained and authorised by Trumpf
Medical.
After every maintenance or repair event, an electrical safety test must be performed.
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 lifespan 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 applies a quality management system certified in accordance

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with DIN EN ISO 13485 for all company processes.
• This guarantees:
– Top quality,
– Easy operation,
– Functional design,
– Optimisation for the intended purpose.
1.4.6 Date of manufacture
The device label indicates the date of manufacture of the device. The position of the
device label on the device is shown in Chapter 4.1.
1.5 Delivery
Before installation, check the delivered components for intactness and for any
possible transportation damage.
• To check the delivery, unpack all components and carry out visual inspection.
• The components can be identified by the order number on the delivery note and/
or the order-specific dimension sheet.
The following applies to Japan: The mains connection wiring may only be used with
the equipment supplied.
1.5.1 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 / 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.
1.5.2 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
1.6 Information for users
The device may only be operated by persons who have undergone appropriate
training.

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1.6.1 Training on the device
Training Training of users 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 training, it must be documented that the user has understood
the special operating procedures required for proper use.
1.6.2 Obligation of the user to inform and to inspect
Dealing with problems The instruction manual must be read carefully 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.
1.7 Conformity
1.7.1 Identification
Conformity The manufacturer declares that this product conforms to the fundamental
requirements according to MDD Appendix I and documents this by means of the CE
and UL marking.
CE mark: This device is a Class I medical device as defined by the European Medical
Device Directive (MDD).
UL mark UL mark: device tested by Underwriter Laboratories Inc. for the USA and Canada with
regard to shock and fire hazard and also mechanical endangerment.
1.7.2 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
/ AMD1: 2012;
/ AMD1: 2013;
2014;

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• UL 60601-1
• ANSI / AMI ES 60601-1
• CAN / CSA-C22.2 NO. 60601-1
Combination with other medical devices
• UL 60601-1
• EN 60601-1
• EN 60601-1-1
1.7.3 Proper use
Proper use Lighting unit for the local illumination of the patient’s body to support diagnoses or
treatments which may be interrupted in case of light failure without hazard to the
patient.
Working range • The working range lies at a distance between 70 and 150 cm to the area being
examined.
• The device is suitable for continuous operation.
• Each use exceeding the aforementioned conditions is considered to fall outside
of the scope of proper use. Only the user or operator will be liable for any loss or
damage arising as a result.
1.7.4 Special features
High light intensity To ensure good visibility, the light head has a high light intensity.
Overlap of the light fields • Visible light also generates heat in the examination area due to physical effects.
The light intensity must be reduced when perfusion is reduced or the tissue starts
to dry out.
Examinations in the field of vision • For examinations in the facial area with unprotected and open eyes, high levels of
local light intensities 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).
1.7.5 Improper use
Improper use The examination light is not intended for use in operating theatres.
• 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 explosion.
• 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.
• The device should not be used in the vicinity of strong magnetic fields.
• 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 is formed in accordance with
EN 11197 in an area between 5 cm and 25 cm from the point of outflow or escape
of the gas.
1.8 Ambient conditions for operation and storage
Various ambient conditions apply to the operation and temporary storage of the
device.

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1.8.1 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.
1.8.2 Ambient conditions for storage
• Ambient temperature: -15 °C to 60 °C;
• Relative humidity: 5 % to 95 %;
• Air pressure: 500 hPa to 1060 hPa
1.9 Combination with other medical devices
Observe the instruction manuals of
combined medical devices
• The system can be combined with medical devices from other manufacturers
(e.g. monitoring systems). The operation of the devices is described in the
relevant instruction manual.
• Only medical devices approved in accordance with IEC 60601-1 or UL 60601-1
may be attached to the system. If a medical device is installed subsequently,
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™ 1000 examination light.
• 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.
1.10 Disposal
The device must be disposed of in accordance with the requirements of directive
WEEE II 2012 / 19 / EU and relevant national regulations 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 user manual
Important information is shown in this user manual by means of symbols and signal
words.
2.1.1 Indicating risk of injury
Signal words such as DANGER, WARNING or CAUTION indicate the severity of the
hazard. Various triangle symbols are used to add visual emphasis.
DANGER indicates an immediately dangerous situation in which non-compliance can
cause death or serious injury.
WARNING indicates a potentially dangerous situation in which non-compliance may
cause death or serious injuries.
CAUTION indicates a potentially dangerous situation in which non-compliance may
cause minor injuries.
2.1.2 Indicating damage to property
ATTENTION indicates a potentially dangerous situation, which, unless avoided, can
lead to damage to property.
2.1.3 Indicating additional information
NOTE provides you with additional information and helpful tips for safe and efficient
use of the device.
2.2 Additional symbols for the safety information
Gas explosion: warns against the explosive ignition of gas mixtures.
Electric shock: warns against an electric shock, which can cause serious injury or
even death.
The spring arm may bounce up: warns of the spring arm jumping up while
dismantling the light head / flat screen.
Lighting system falling down: warns of a sudden downwards movement of the light
system when it is exposed to additional load.
Patient eye protection: warns of damage to the patient's vision in examinations or
surgery in the field of vision.
Damage to surfaces: warns against damages to surfaces caused by unsuitable
cleaning agents and disinfectants.
DANGER
WARNING
CAUTION
ATTENTION
NOTE

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2.3 Symbols on the device
CE conformity mark: certifies the conformity of the device with the European
product directive (Medical Device Directive (MDD).
Follow the Instruction Manual: refers to this instruction manual.
UL mark: 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
may not be possible to apply to the medical device for a range of reasons.
2.4 Overview of the most important safety instructions
Location requirements
Gas explosion
The lighting system is not suitable for use in an environment
in which flammable mixtures of anaesthetics with oxygen or
laughing gas in a high concentration are used.
Mixtures of combustible anaesthetic vapours with oxygen or laughing gas
may arise in the vicinity of the device in a sufficiently high concentration
that ignition may occur under certain circumstances.
The danger area is formed in accordance with EN 11197 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.
---------------------------------------------------------------------------------------
BF / CF Class application components
No BF or CF Class application components in accordance with IEC 60601-1
may be directly connected to the support arm systems of the lighting
system.
Electric shock
The lighting system may only be connected to an
appropriately earthed power supply with protective
conductors in order to avoid the risk of an electric shock.
DANGER
WARNING

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Examinations in the field of vision
Damage to vision
In case of examinations 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 protective glasses.
• Do not look directly into the light-emitting surface area of the light.
Strong light fields
Damage to patient's tissue
High levels of illumination may cause damage to tissue. In cases of
incipient tissue dehydration, reduce the intensity of illumination of the
light head.
Electrostatic charge balance
Complications due to electrostatic discharge
To avoid complications due to electrostatic discharge between parts of
the device and patients, the user must not touch parts of the examination
light and the patient at the same time.
Additional loads
Crashing of the light system
Do not place any additional weight on the light system.
Light intensity of the light head
LED failure
After failure of the third LED, the light head no longer achieves the
specified light intensity.
• Take the lighting system out of service.
• Contact Technical Customer Service. Exchange of the light head or
repairs on the lighting system may only be performed by the technical
customer service.
WARNING
WARNING
WARNING
WARNING
CAUTION

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Swivel movement of the light head
Risk of injury due to uncontrolled swivel movement
Uncontrolled movement of the spring arm may result when
the spring force of the spring arm is not correctly adjusted.
---------------------------------------------------------------------------------------
Risk of jamming
When swivelling the light head, the distance between the
quarter bracket and the light head changes:
• Do not insert your fingers between the quarter bracket and the light
head when rotating the light head.
• Only grasp the light head with the sterilisable handle.
Cleaning and disinfection
Improperly used cleaning agents or disinfectants (see Chapter 8)
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.
• To clean or disinfect the device, the cloth for wiping must be moist
and not wet.
• 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
WARNING
WARNING

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– To prevent paint or corrosion damage, only use agents that do not contain
chlorides or halides.
•Please refer to Chapter 9 for the sterilisation of handles.
• It is essential that the hygiene instructions of the operator are
observed.
Adjustments
Adjusting the device
The manufacturer guarantees the safety and proper working of the
device only under the condition that the work of adjustment has been
done by an authorised hospital technician or a person with equivalent
qualification.
Deinstallation for service purposes
The spring arm may bounce up
If the light head is removed without first moving the spring
arm to the highest limit position, the spring arm will shoot up
and can cause severe injuries:
• The light head may therefore only be de-installed by the technical
customer service
Commissioning
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.
CAUTION
WARNING
CAUTION

55000-00012_002_01 – 1695233 – 25/01/2018 20
3 The technology of the lighting system
3.1 The light head
Operation The light head is ergonomically adjusted via the non-sterile control panel on the light
head.
Light intensity The light intensity can be set in the range from 30 % to 100 %. A reduction (dimming)
of the light intensity does not change the colour temperature of the light.
3.2 The LED light source
The light head is equipped with LED light sources.
Service life LEDs have a very long 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
(infra-red) 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.
Homogeneous colour temperature The equipment of the light head with LEDs allows a homogeneous colour
temperature in the range of 4,500 Kelvin.