Trumpf Trulight5000 Instruction Manual
Trumpf Trulight5000 Instruction Manual
Trumpf Trulight5000 Instruction Manual
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.
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.
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
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
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
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.
1.4.3 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
1.6 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.
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.
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).
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).
NOTE provides you with additional information and helpful tips for safe and efficient
NOTE
use of the device.
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.
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).
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.
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.
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.
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.
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.
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.
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
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.
• Only position the light head by using the sterile handle or the non-
sterile handles (outer handles).
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
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.
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.
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.
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
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).
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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).
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.
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.
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).
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.
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.
WARNING
Electric shock
Touching live components may result in an electric shock.
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.
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.
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The warranty applies only to undamaged surfaces!
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.
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.
• 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.
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.
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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.
10.2.1 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.
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.
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.
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.
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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.
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.
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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.
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.
ATTENTION
Screw types for the friction brakes
The brake screws are slot-head screws:
All other types of screw must not be loosened.
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:
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)
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
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
* = at a distance of 0.9 m
* = at a distance of 0.9 m
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).
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.
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.
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".
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.
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.
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.