BiliLux Instructions for Use sw 1.n Edition Aug 2019.pdf
Page 1
Instructions for use
BiliLux
WARNING
To properly use this medical device,
read and comply with these
instructions for use.
LED phototherapy light
Software 1.n
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Instructions for use BiliLux
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Contents
Contents
1
Information about this document .................................................................
1.1
Typographical conventions ...................................................................
1.2
Illustrations ............................................................................................
1.3
Use of terms .........................................................................................
1.4
Trademarks ...........................................................................................
2
Safety-related information ............................................................................ 9
2.1
Target groups ....................................................................................... 9
2.2
Information on safety instructions and precautionary statements ....... 10
2.3
Basic safety instructions ..................................................................... 11
2.4
Device compatibility safety ................................................................. 13
2.5
Safety instructions for accessories ..................................................... 13
2.6
Electrical safety ................................................................................... 14
2.7
Explosion and fire protection .............................................................. 15
2.8
Drug storage precautions ................................................................... 15
2.9
Mechanical safety ............................................................................... 16
2.10 Device failure ...................................................................................... 16
3
Application ...................................................................................................
3.1
Intended use .......................................................................................
3.2
Environment of use .............................................................................
3.3
Indications/contraindications ...............................................................
17
17
17
17
4
Overview .......................................................................................................
4.1
BiliLux phototherapy light ....................................................................
4.2
BiliLux with optional spring arm ..........................................................
4.3
BiliLux with optional trolley ..................................................................
4.4
Radiometer (optional) .........................................................................
4.5
Description ..........................................................................................
4.6
Abbreviations ......................................................................................
4.7
Definitions ...........................................................................................
4.8
Symbols ..............................................................................................
19
19
20
21
22
22
23
24
24
5
Operating concept .......................................................................................
5.1
Control panel ......................................................................................
5.2
Displaying BiliLux screens ..................................................................
5.3
Adjusting the BiliLux with spring arm ..................................................
27
27
28
29
6
Assembly and preparation ..........................................................................
6.1
Unpacking ...........................................................................................
6.2
Proper assembly .................................................................................
6.3
Placing the BiliLux phototherapy light on an incubator hood ..............
6.4
Installing the BiliLux with optional spring arm .....................................
6.5
Installing the BiliLux with optional trolley ............................................
6.6
Installing the optional radiometer ........................................................
31
31
31
32
32
34
35
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7
7
7
7
7
3
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Contents
7
Getting started ............................................................................................. 37
7.1
System startup .................................................................................... 37
7.2
Functional check procedure ................................................................ 38
8
Operation ......................................................................................................
8.1
Positioning the BiliLux .........................................................................
8.2
Adjusting light distance and coverage for the patient .........................
8.3
Starting therapy ..................................................................................
8.4
Using the BiliLux radiometer (option) ..................................................
8.5
Exporting a phototherapy report .........................................................
8.6
Checking device status .......................................................................
8.7
Ending phototherapy ...........................................................................
8.8
Using the MEDIBUS.X interface for data transfer ...............................
8.9
Shutting down the device ....................................................................
9
Configuration ............................................................................................... 55
9.1
Adjusting the date and time ................................................................ 55
9.2
Adjusting the language ....................................................................... 56
41
43
47
48
49
50
51
52
52
53
10 Troubleshooting ........................................................................................... 57
11 Reprocessing ...............................................................................................
11.1 Disassembly .......................................................................................
11.2 Information on reprocessing ...............................................................
11.3 Classifications for reprocessing ..........................................................
11.4 Reprocessing list ................................................................................
11.5 Reprocessing procedures ...................................................................
11.6 After reprocessing ...............................................................................
11.7 Preparations before reuse ..................................................................
59
59
59
60
61
61
63
63
12 Service ..........................................................................................................
12.1 Safety information ...............................................................................
12.2 Overview .............................................................................................
12.3 Definition of service terminology .........................................................
12.4 Inspection ...........................................................................................
12.5 Maintenance .......................................................................................
12.6 Maintenance instructions ....................................................................
12.7 Repair .................................................................................................
65
65
66
66
66
67
67
68
13 Disposal ........................................................................................................ 69
13.1 For countries subject to the EU Directive 2002/96/EC ....................... 69
14 Technical data ..............................................................................................
14.1 Device classification ...........................................................................
14.2 Physical attributes ...............................................................................
14.3 Environmental requirements ...............................................................
14.4 Electrical requirements .......................................................................
14.5 Noise requirements .............................................................................
14.6 RS-232 communication port ...............................................................
14.7 Irradiance ............................................................................................
4
71
71
71
73
73
73
73
74
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Contents
14.8 Radiometer option requirements ........................................................ 75
14.9 Device combinations ........................................................................... 76
14.10 EMC Declaration ................................................................................. 76
15 List of accessories .......................................................................................
15.1 Device .................................................................................................
15.2 Accessories ........................................................................................
15.3 Optional components ..........................................................................
83
83
83
83
Index .............................................................................................................. 85
Instructions for use BiliLux
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Information about this document
1
Information about this document
1.1
Typographical conventions
1
Consecutive numbers indicate steps of action, with the numbering
restarting with "1" for each new sequence of actions.
Bullet points indicate individual actions or different options for action.
–
Dashes indicate the listing of data, options, or objects.
(A)
Letters in parentheses refer to elements in the related illustration.
A
Letters in illustrations denote elements referred to in the text.
►
Preventive measures in a safety message.
Result of a step.
✓
Final result of a sequence of steps.
Indicates information that makes it easier to use the product.
Bold, italicized text indicates labels on the device and texts that are
displayed on the screen.
1.2
Illustrations
Illustrations of products and screen content in this document may differ from the
actual products depending on configuration and design.
1.3
Use of terms
Dräger uses the term "accessories" not only for accessories in the sense of
IEC 60601-1, but also for consumables, removable parts, and attached parts.
1.4
Trademarks
Trademark
Trademark owner
Babytherm®, BiliLux®, Caleo®,
Dräger
Actichlor
Ecolab
BruTab 6S
Brulin
Dispatch
Clorox
Buraton, Mikrozid,
Schülke & Mayr
MEDIBUS®
Perform, acryl-des
Descogen
Antiseptica
Dismozon
Bode Chemie
Klorsept
Medentech
Oxycide
Ecolab USA
Virkon
DuPont
Eyemax
Maxtec
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Safety-related information
2
Safety-related information
2.1
Target groups
2.1.1
Duties of the operating organization
The tasks described in this document specify the requirements that have to be met
by each respective target group.
The operating organization of this product must ensure the following:
– The target group has the required qualifications (e.g., has undergone specialist
training or acquired specialist knowledge through experience).
– The target group has been trained to perform the task.
– The target group has read and understood the chapters required to perform the
task.
2.1.2
Description of target groups
The target groups may only perform the following tasks if they meet the
corresponding requirements.
2.1.2.1
2.1.2.2
2.1.2.3
User
Task
Requirement
Use of the product in accordance with
the intended use
Specialist medical knowledge in
neonatology and in the use of the
product
Reprocessing personnel
Task
Requirement
Reprocessing
Specialist knowledge in the reprocessing
of medical devices
Service personnel
Task
Requirement
Installation
Experience in the servicing of medical
devices
Basic service work (inspection, maintenance according to the "Maintenance"
chapter)
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Safety-related information
2.1.2.4
Specialized Service Personnel
Task
Requirement
Basic and complex service work (inspec- Specialist knowledge in electrical engition, maintenance, repair)
neering and mechanics
Experience in the servicing of medical
devices
Experience in complex service work on
this product
Dräger recommends arranging a service contract with DrägerService.
2.2
Information on safety instructions and precautionary
statements
Safety instructions and precautionary statements warn of risks and give instructions
for the safe use of the product. Failure to observe them may lead to personal injury
or property damage.
2.2.1
Safety instructions
This document contains sections with safety instructions that warn of risks. The
type of risk and the consequences of non-compliance are described in each safety
instruction.
2.2.2
Precautionary statements
Precautionary statements relate to process steps and warn of risks that may arise
when executing the process steps. Precautionary statements precede the process
steps.
The following warning signs and signal words indicate precautionary statements
and differentiate the possible consequences of noncompliance.
Symbol
10
Signal word
Consequences of non-compliance
WARNING
May result in death or serious injury.
CAUTION
May result in moderate or minor injury.
NOTICE
May result in property damage.
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Safety-related information
2.3
Basic safety instructions
The following statements apply to general operation of the medical device.
2.3.1
Strictly follow these instructions for use
Failure to observe these safety information statements constitutes a use of the
medical device that is inconsistent with its intended use.
► Any use of the medical device requires full understanding and strict observation
of all sections of these instructions for use. The medical device must only be
used for the purpose specified under Intended use on page 17 and with
appropriate patient monitoring (see page 12).
► Strictly observe all precautionary statements throughout these instructions for
use and all statements on medical product labels.
► Instructions for use must be kept accessible to the user.
2.3.2
Restrictions for use
► Device for use in healthcare facilities only and exclusively by persons with
specific training and experience in its use.
2.3.3
Service
If service is not performed regularly, malfunctions may occur, which can result in
personal injury and property damage.
► Observe chapter Service.
► The medical device must be inspected and serviced regularly by service
personnel. Repair and complex maintenance carried out on the medical device
.
must be performed by specialized service personnel.
► Dräger recommends that a service contract is obtained with DrägerService and
that all repairs are performed by DrägerService. For maintenance, Dräger
recommends the use of authentic Dräger repair parts.
► Do not service or maintain the device while it is in use with a patient.
2.3.4
Safety checks
The medical device must be subject to regular safety checks. See chapter Service.
2.3.5
Modifications to the product
Modifications to the product may lead to malfunctions and unforeseen risks. This
may result in injury to the patient or the user or in property damage.
► Do not modify this product.
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Safety-related information
2.3.6
Training
Training for users is available from the Dräger organization. See www.draeger.com.
Device misuse may result in harm to an infant.
► Only properly trained personnel should use the device as directed by a qualified
attending physician familiar with the currently known risks and benefits of infant
phototherapy equipment.
2.3.7
Patient safety
The design of the medical device, the accompanying documentation, and the
labeling on the medical device are based on the assumption that the purchase and
the use of the medical device are restricted to persons familiar with the most
important inherent characteristics of the medical device.
Instructions and precautionary statements are therefore limited to the specifics of
the Dräger medical device.
The instructions for use do not contain any information on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the medical device
– Potentially negative effects on patients with different underlying diseases
Medical device modification or misuse can be dangerous.
Risk of patient injury.
► Do not make therapeutic decisions based solely on individual measured values
and monitoring parameters.
► Assess the patient frequently to observe any change in condition.
► To make therapeutic decisions, also use medical expertise and visual
assessment of patient.
► If the surface that the patient is lying on is equipped with protective devices
designed to prevent the patient from falling off, ensure that they are inspected
regularly for safety.
2.3.8
Patient monitoring
Patient safety can be achieved by a wide variety of means ranging from electronic
surveillance of medical device performance and patient condition to direct
observation of clinical signs.
The user of the medical device is responsible for choosing a suitable patient
monitoring system that provides appropriate information on medical device
performance and patient condition.
The responsibility for selecting the best level of patient monitoring lies solely with
the user of the medical device.
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Instructions for use BiliLux
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Safety-related information
2.3.9
Safe connection with other electrical equipment
Unapproved electrical connections can lead to patient injury or device failure.
► Electrical connections to equipment not listed in these instructions for use or
these assembly instructions must only be made when approved by each
respective manufacturer.
► Connecting electrical equipment to a power socket strip effectively leads to
creating a medical electrical system. The result can be a reduced level of safety.
Comply with the requirements of IEC 60601-1 when constructing a medical
electrical system.
2.4
Device compatibility safety
The use of incompatible devices may adversely affect the functional integrity of the
product. Personal injury and property damage may occur as a consequence.
► Ensure that other medical devices that are used in conjunction with the patient
or that form a system with this device are in compliance with the applicable
medical device requirements.
► Do not use the device adjacent to or stacked with other equipment unless
verification of normal operation in such a configuration can be achieved.
► If other devices are used with the BiliLux, refer to their manufacturer’s
instructions for use.
2.5
Safety instructions for accessories
2.5.1
Accessories
The use of incompatible accessories may adversely affect the functional integrity of
the product. Personal injury and property damage may occur as a consequence.
► Dräger has tested the compatibility only of accessories listed in the current list of
accessories.
► Use only compatible accessories. The accessories that are compatible with this
product are listed in the list of accessories supplied with the product.
2.5.2
Reusing or reprocessing accessories
Reusing, reprocessing, or sterilizing disposable products can lead to a failure of the
medical device and cause injury to the patient.
► Do not reuse, reprocess, or sterilize disposable products. Disposable products
were designed, tested, and manufactured for one-time use only.
► Do not use packaged disposable products if the package has been
compromised.
Reusable accessories have a limited service life. Using accessories beyond their
service life can lead to a failure of the medical device and cause injury to the
patient.
► If the accessory shows external signs of wear such as cracks, deformations,
discoloration, or peeling, exchange the accessory.
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Safety-related information
2.6
Electrical safety
The potential for electrical shock exists when electrical equipment is used. To avoid
the risk of personal injury and property damage, the following preventive measures
must be taken:
► Establish policies and procedures to educate your staff on the risks associated
with electrical equipment.
► Due to the risk of electrical shock, only properly trained personnel with
appropriate service documentation should service the device.
► This device must only be connected to a properly grounded hospital-grade
power socket.
► Due to potential shock hazard within the phototherapy light, do not use the
device if the phototherapy light or other components fail to function properly.
► Always provide power to the device by connecting the power cable directly to
the mains power supply.
► Do not use extension power cables or power socket strips.
► Do not connect any devices or accessories that operate on mains voltage to the
USB port.
2.6.1
Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to special precautionary measures
concerning electromagnetic compatibility. Observe the EMC information during
installation and initial operation. For further information, see the following section:
EMC Declaration on page 76.
Portable and mobile high-frequency communication equipment can affect medical
electrical equipment.
Malfunctions that endanger the patient may occur if no protective measures against
electrostatic discharge are employed in the following situations:
► When touching the pins of connectors that carry the ESD warning symbol.
► When establishing connections with these connectors.
To prevent malfunctions, observe the following measures and train the relevant
personnel:
► Observe the ESD protective measures. Such measures may include wearing
anti-static clothing and shoes, touching a potential equalization pin before and
while making the connection, or using electrically insulating and anti-static
gloves.
► Observe the requirements for the electromagnetic environment. Observe the
following section: "Electromagnetic Immunity" on page 78.
Electromagnetic fields may interfere with the device function and consequently
endanger the patient. Electromagnetic fields are generated by, e.g.:
– Cellular phones
– High-frequency electrosurgical equipment
– Defibrillators
– Shortwave therapy equipment
► Maintain the separation distances. Observe the following section:
"Recommended separation distances" on page 81.
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Safety-related information
The device is designed to comply with electromagnetic compatibility requirements.
However, potential electromagnetic or other interference may exist. If interference
is observed:
► Move the equipment or identify the source of interference, and take appropriate
action.
2.6.2
EMC precautions
The use of accessory equipment not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety of the resulting
system.
► All medical accessory equipment in the patient vicinity must comply with the
safety requirements of IEC 60601-1 and must have the relevant safety
certifications.
► Use of accessories other than what is listed and approved for use in this product
as original or replacement items may result in increased electromagnetic
emissions or decreased electromagnetic immunity.
► Devices connecting to the serial port must be compliant with IEC60601-1-2, the
EMC requirement for Medical Devices.
► Medical electrical equipment needs special precautions regarding EMC and
must be installed and put into service according to the EMC information
provided in this manual.
► In addition, portable and mobile RF communications equipment can affect
medical electrical equipment.
2.7
Explosion and fire protection
Use of the device in areas of explosion and fire hazard can lead to patient injury or
device failure.
► Do not use the device in areas where combustible gases are present (e.g.,
oxygen, nitrous oxide, anesthetic agents). The medical device is not approved
for use in areas where combustible or explosive gas mixtures are likely to occur.
► Textiles, oils, and other combustibles are easily ignited and burn with great
intensity in air enriched with oxygen. Keep matches, and all other sources of
ignition, out of the room in which the device is located.
► Ensure adequate ventilation to avoid accumulation of oxygen around the device.
► Do not place auxiliary equipment that produces sparks near the device.
► Ensure that no oxygen sources are in use during maintenance or cleaning.
2.8
Drug storage precautions
Photo effects of radiation can degrade the efficacy of drugs.
► Do not store infusion liquids or other drugs in the radiation area.
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Safety-related information
2.9
Mechanical safety
2.9.1
Using the phototherapy light with an incubator
► Phototherapy lights placed on top of the incubator may inadvertently fall off if the
incubator is moved. Before moving the incubator, disconnect the phototherapy
light from mains power and remove it from the top of the incubator.
► Phototherapy lights placed on the top of the incubator hood may interfere with
upward travel of the height adjustment of the incubator. To prevent this
interference, always remove the phototherapy light before adjusting the
incubator height.
2.9.2
Moving the trolley
To prevent injuries and damage to the device when moving the trolley, prepare the
trolley as follows:
► Remove or secure all loose system components.
► Fold the spring arm down to a compact position.
► Lower the trolley pole to its lowest position.
► Push or pull the trolley in a straight line along the length of the trolley. Lateral or
angular movement (across the width) can result in inadvertent tip-over if the
wheels encounter any obstacle.
► Do not use the phototherapy light to move the trolley.
2.9.3
Preventing tip over of trolley
The device could tip over.
► For optimum stability, always lower the trolley to its lowest position before
moving the device.
► For optimum stability, always lock all trolley wheels.
► Do not leave the device unattended when parking on an incline.
2.10
Device failure
In case of device failure, contact DrägerService.
16
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Application
3
Application
3.1
Intended use
The BiliLux phototherapy light is designed to reduce the serum bilirubin
concentration in premature babies and neonates with hyperbilirubinemia by means
of phototherapeutic radiation. It is intended for use with patients up to 3 months of
age who weigh less than 10 kg (22 lb).
3.2
Environment of use
The BiliLux phototherapy light can be used in hospital departments that provide
neonatal and infant care, including nurseries and Neonatal Intensive Care Unit
(NICU) levels I-IV.
3.3
Indications/contraindications
The BiliLux phototherapy light is indicated for the reduction of hyperbilirubinemia in
newborn infants up to 3 months of age who weigh less than 10 kg (22 lb).
The BiliLux phototherapy light is not indicated for home use or for use inside an
incubator. It is also not indicated for the following patients:
– patients with conjugated hyperbilirubinemia
– patients with photosensitizing disorders (e.g., congenital erythropoietic
porphyria)
– patients who are being given photosensitive medication
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Overview
4
Overview
4.1
BiliLux phototherapy light
4.1.1
Top view
B
BiliLux
001
A
A Control panel
B Quick-connect plug (for connection to optional spring arm)
4.1.2
Bottom view
C
B
B
002
A
A Blue phototherapy LED lights
B White observation LED lights
C Rating plate
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Overview
4.1.3
Rear view
A
D
C
E
F
003
B
A On/off switch
B Power cable receptacle
C Quick-connect plug (for connection to optional spring arm)
D RS-232 communication port
E Receptacle for radiometer cable
F USB port
4.2
BiliLux with optional spring arm
A
B D
C
D
F
004
E
A Quick-connect for phototherapy light
B Release knob for phototherapy light
C Spring arm
D Cable clips
E Plug to connect to trolley pole or rail clamp
F Rail clamp for phototherapy light (to connect to 38 mm pole and DIN, Fairfield,
and GCX rails)
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Overview
4.3
BiliLux with optional trolley
A
B
C
D
E
005
F
A Spring arm
B Tightening knob for spring arm
C Trolley pole
D Height adjustment knob
E Cable holder (optional)
F Trolley base with locking castors
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Overview
4.4
Radiometer (optional)
Front view
Rear view
A
B
C
E
007
D
A Sensor
B Store button (to store an irradiance measurement)
C Cable (to connect to phototherapy light)
D Calibration due date label
E Magnets
4.5
Description
The BiliLux is a configurable phototherapy light that uses LED technology to
provide treatment of hyperbilirubinemia in newborn infants. The BiliLux
phototherapy light can be combined with a spring arm and trolley. An optional
radiometer is also available to measure the phototherapeutic effective irradiance
produced by the phototherapy light.
BiliLux phototherapy light
The BiliLux phototherapy light can be placed directly on an incubator hood. It has
slip-resistant feet on the bottom that help to hold it in place. The phototherapy light
houses the 20 blue lights that provide therapy as well as 2 white lights used for
observation. The front panel has a display screen and keys to control functions and
change settings. The BiliLux phototherapy light also has the capability to produce a
phototherapy report via export to a USB flash drive that is supplied with the device.
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Overview
BiliLux with optional spring arm
The BiliLux with spring arm consists of the phototherapy light, an adjustable spring
arm, and mounting provisions that allow the BiliLux to be used with various Dräger
warming therapy devices and ceiling supply units. When mounted on the arm, the
phototherapy light can be rotated and positioned for optimum effectiveness. It can
be easily attached and released from the spring arm by using the quick-connect
mechanism.
BiliLux with optional trolley
The BiliLux with trolley consists of the phototherapy light, an adjustable spring arm,
and a rolling trolley that allows use above an incubator, radiant warmer, crib, or
bassinet.The trolley has 4 locking castors and a height-adjustable pole. These
features, together with the adjustable spring arm, allow the BiliLux to be moved,
rotated, and positioned for optimum effectiveness. The phototherapy light can be
easily attached and released from the spring arm by using the quick-connect
mechanism.
4.6
Abbreviations
The following abbreviations appear on the device or in these instructions for use.
Abbreviation
Meaning
AC
Alternating current
AP
Anesthetic-proof
DIN
Deutsches Institut für Normung
EMC
Electromagnetic compatibility
ESD
Electrostatic discharge
GMDN
Global Medical Device Nomenclature
IEC
International Electrotechnical Commission
LED
Light-emitting diode
NICU
Neonatal intensive care unit
RI
Revision index
SN
Serial number
UMDNS
Universal Medical Device Nomenclature System
USB
Universal serial bus
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Overview
4.7
4.8
Definitions
Term
Definition
Congenital
erythropoietic
porphyria
A rare metabolic disorder affecting the synthesis of the ironcontaining pigment that binds oxygen onto red blood cells.
Conjugated
hyperbilirubinemia
Hyperbilirubinemia caused by defective excretion of
conjugated bilirubin by the liver cells, or by anatomical
obstruction to bile flow within the liver or in the extrahepatic
bile duct system (as with hepatitis or biliary obstruction).
Cyanosis
Bluish discoloration of the skin due to poor circulation or
insufficient oxygenation of the blood.
Hyperbilirubinemia
Abnormally high level of bilirubin in the blood and in the
subcutaneous layers.
Irradiance
Radiant power emitted by the phototherapy light.
Symbols
The following symbols appear on the device, device packaging, and in these
instructions for use.
Symbol
24
Meaning
Symbol
Meaning
Warning
Electromagnetic interference
Caution
Do not reuse
Follow instructions for use
Part number
REF
Protect patient’s eyes
Lot number
Power On
Quantity of contents
Power Off
Manufacturer
AC power
Date of manufacture
Storage temperature
Use by date
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Overview
Symbol
Meaning
Symbol
Meaning
Relative humidity range
Keep away from rain
Atmospheric pressure
range
Do not use if package is
damaged
Fragile, handle with care
Trolley transport label
Weight limit
Do not discard with regular
waste
Total mass including safe
working load
Key to switch white light
on/off
Calibration due date
Menu key
Key used to start/pause
therapy
Therapy on
Key to increase irradiance
Therapy paused
Key to decrease irradiance
Follow operating instructions
Earth (ground) / Functional
earth
Protective earth (ground)
Store button
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