Operating Instructions AmbientLine Lighting System
1524523_03 AmbientLine Instruction Manual EN
2Thank you very much
for purchasing the new AmbientLine lighting system. Please read
these operating instructions very carefully, heed the safety notices
and observe all operating requirements.
CE marking
This device is a Class I Medical Device according to the European
Medical Device Directive (MDD) 93/42/EEC, June 1993,
Appendix IX.
Conformity The manufacturer declares that this product complies with the basic
requirements of MDD Appendix I and shows conformity by means of
the CE mark.
For which devices does this Operating Instructions apply?
?AmbientLine lighting system installed on the incarePORT /
klinoPORT ceiling pendant
Please do not hesitate to contact our Customer Service
Team
?if you have questions about the device and its installation,
?to reorder spare parts,
?in service or warranty cases.
You can reach us under the following address:
?TRUMPF Medizin Systeme GmbH + Co. KG
?Benzstra?e 26
?D-82178 Puchheim
Sales team ?Phone:
+49 / (0)89 / 8 09 07 - 0?Fax:
+49 / (0)89 / 8 09 07 - 2 22Service team
?Phone:
0 180 / 2 25 41 35Phone:
+49 / (0) 36 71/ 5 86 - 0?Fax:+49 / (0) 36 71 / 58 61 75? TRUMPF Medizin Systeme GmbH + Co. KG
?Edition:1524523_03
Release:January 20, 2009
Visit us on the Internet at
https://www.doczj.com/doc/b216257409.html,
Notes on this documentation
Validity?These operating instructions only apply after the successful first
start-up of the AmbientLine lighting system installed on the
incarePORT / klinoPORT ceiling pendant.
Further applicable documents?AmbientLine lighting system is installed on the incarePORT /
klinoPORT ceiling pendant. For more detailed information on
the operation of the incarePORT and klinoPORT ceiling
pendants, refer to the "Ceiling Pendants" Operating
Instructions.
Copyright?The information included in these operating instructions or
parts thereof is the intellectual property of:
TRUMPF Medizin Systeme GmbH + Co. KG,
hereinafter referred to as TRUMPF, and protected by national
and international copyright and other laws on the protection
of intellectual property.
?Any duplication, reproduction, translation, microfilming,
storage in electronic or magnetic form, processing as
electronic or magnetic data, copying or redistribution of these
documents and/or the information included herein or parts of
it is strictly prohibited without the express written consent of
TRUMPF.
?TRUMPF does not take any liability for or in relation to the
misuse of this information in the prohibited manner by any
person or company.
Subject to change without prior notice?TRUMPF reserves the right to change, remove or otherwise
modify the information contained herein at any time, for any
reason and without notice.
?Since our products are subject to continuous further
development, we reserve the right to modify the form,
equipment and technology of our scope of supply.
Intellectual property rights?All rights according to the Law on Intellectual Property expressly
remain with TRUMPF.
Property rights?All documents refer to the device version available and the
safety standards applicable at the time of printing. All property
rights for devices, electric circuits, procedures, software
programs and names are reserved.
Translations?In case of translations into foreign languages, the German
version of these operating instructions shall be binding.
Trademarks?All trademarks mentioned in these operating instructions are
the sole and exclusive property of the corresponding supplier or
manufacturer.
1524523_03 AmbientLine Instruction Manual EN 3
Content
1 Important Safety Notes (6)
1.1 Notes for the User (6)
1.1.1 Requirements with Regard to the Qualification of the User..6
1.1.2 Requirements with Regard to the Qualification of the
Hygiene Personnel (6)
1.1.3 Responsibility for Maintenance and Repair (6)
1.1.4 Duty to Inform (6)
1.2 Notes for the Operator (7)
1.2.1 Initial Commissioning (7)
1.2.2 Operation and Maintenance (7)
1.2.3 Duty of Instruction (7)
1.2.4 Availability of the Operating Instructions (7)
1.2.5 Warranty (8)
1.3 Intended Use of the Device (8)
1.3.1 Use as Prescribed (8)
1.3.2 Incorrect Use (8)
1.3.3 Special Features for Use of the AmbientLine
Lighting System (9)
1.3.4 Declaration of Conformity and Approvals (9)
1.3.5 Shipping and Storage (9)
1.3.6 Ambient Conditions (9)
1.3.7 Use in Combination with other Medical Devices (9)
1.3.8 Disposal (9)
1.3.9 Structure of the Safety Instructions (10)
1.4 Overview of the Most Important Safety Instructions (12)
2 Device and Functional Description (14)
2.1 Device Description (14)
2.1.1 Lighting Units and Light Sail (14)
2.1.2 Operator Panel (14)
2.2 Functional Description (16)
2.2.1 Operator Panel (16)
2.2.2 Lighting on the Operator Handle of the Platforms (16)
3 Operation (18)
3.1 General Operating Functions (18)
3.2 Lighting Units for the Operating Room (OR) (18)
3.3 Lighting Units for the Intensive Care Unit (ICU) (18)
3.4 Operation of the Lighting Units (20)
3.4.1 Switching the Operator Panel On and Off (20)
3.4.2 Switching the Lighting On and Off (20)
3.4.3 Adjusting the Light Intensity (20)
3.4.4 Selecting Lighting Scenarios (20)
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1524523_03 AmbientLine Instruction Manual EN
Content
3.5 Lighting Units on the Operator Handle of the Platforms (20)
3.6 Defining Color Settings and Color Scenarios (22)
3.6.1 Calling Up the Color Settings Menu (22)
3.6.2 Defining the Lighting Mode and the Color Setting (22)
4 Cleaning and Disinfection (24)
4.1 Cleaning (24)
4.2 Disinfection (25)
5 Inspection, Maintenance and Repair (26)
5.1 Annual Inspections by the Operator (26)
5.2 Five-Year Warranty by the TRUMPF Aftersales Service (26)
5.3 Repair (27)
6 Removing / Replacing the Light Sail (28)
6.1 Removing the light sail (28)
6.2 Replacing the Light Sail (28)
6.3 Inserting the Light Sail (30)
7 Technical Data (32)
1524523_03 AmbientLine Instruction Manual EN5
1Important Safety Notes
1.1Notes for the User
Subject of the operating instructions These Operating Instructions describe the AmbientLine Lighting
System installed on the incarePORT / klinoPORT Ceiling Pendant.
Only qualified, authorized personnel may operate this device.
1.1.1 Requirements with Regard to the Qualification of
the User
Qualified personnel The following persons shall be considered as qualified personnel:
?persons who underwent special professional training in the field
of medical engineering,
?persons who, based on their professional experience and
training in safety-related regulations, are duly qualified for their
professional activities and able to recognize any potential
danger involved.
?In States where job activities in the medical engineering sector
are subject to certification, qualified personnel must have
obtained the corresponding certificate.
1.1.2 Requirements with Regard to the Qualification of
the Hygiene Personnel
Hygiene personnel?To use the device under hygienic conditions, the cleaning and
disinfection of the device or parts thereof may only be carried
out by hygiene personnel who are familiar with the hygiene
regulations of the area of use.
?When used outside hygienic areas, the device can be cleaned
by instructed cleaning personnel.
1.1.3 Responsibility for Maintenance and Repair
Maintenance and repair?The device is totally maintenance-free in daily operation.
?Maintenance work on the device may only be carried out by
authorized technicians.
?For a list of contact details of service centers, refer to your
supplier.
1.1.4 Duty to Inform
Duty to inform Please read these Operating Instructions carefully prior to
initial operation of the device. This ensures that you
benefit from all the advantages of the device and prevent
damage.
In case of special problems which are not sufficiently
described in detail in these Operating Instructions,
contact your supplier for your own safety.
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1524523_03 AmbientLine Instruction Manual EN
1 Important Safety Notes
1.2Notes for the Operator
Procedural guidelines?The AmbientLine Lighting System installed on the incarePORT /
klinoPORT Ceiling Pendant has been designed according to
the state of the art and is safe to operate. Nevertheless, the
device must be considered a potential source of danger, in
particular when operated by insufficiently trained personnel or
used improperly and not as prescribed.
?To prevent damage to persons and property, the following
procedural guidelines must be adhered to.
1.2.1 Initial Commissioning
Initial commissioning?Initial commissioning of the device must be carried out by
service personnel authorized by the supplier.
?As soon as the device has been released for operation, the
instructions provided in these Operating Instructions are
binding.
1.2.2 Operation and Maintenance
Operation and maintenance?The device may only be operated by authorized and instructed
personnel.
?Maintenance work on the device must be carried out by
authorized technical service centers. Maintenance of the device
or parts thereof shall be carried out by the supplier or by a
service provider on site.
1.2.3 Duty of Instruction
Instruction by way of documented procedures Based on these operating instructions, applicable safety data sheets, hygiene regulations and applicable technical rules, the operator shall create documented procedures for personnel working on this device, including in particular the following information:?measures of decontamination to be taken for the device and auxiliary material to be used,
?measures of protection to be adhered to for cleaning and disinfection,
?measures to be taken in case of accident.
1.2.4 Availability of the Operating Instructions
Availability These Operating Instructions are included in the scope of supply of
the device.
Always keep them near the device in order to be able to look up
safety instructions and important information on use at any time.
1524523_03 AmbientLine Instruction Manual EN 7
1Important Safety Notes
1.2.5 Warranty
Warranty The warranty of TRUMPF for the safety and operational reliability of
the AmbientLine Lighting System is subject to the following
conditions:
?The device is used exclusively as prescribed and operated,
maintained and repaired as stipulated in these Operating
Instructions.
?Only spare parts and accessories authorized by TRUMPF are
used.
?No structural alterations are made on the device.
?Inspections and maintenance is carried out at the specified time
intervals.
?Initial commissioning has been carried out and the device has
been released for operation by means of a declaration of
acceptance.
1.3Intended Use of the Device
This device is a Class I Medical Device according to the European
Medical Device Directive (MDD) 93/42/EEC, June 1993, Appendix
IX.
1.3.1 Use as Prescribed
The AmbientLine Lighting System:
Intended use?is an accessory to the incarePORT / klinoPORT Ceiling
Pendant,
?serves for illumination of the room,
?serves for illumination of the patient,
?illuminates the working range in the environment of the patient,
?increases the patient's well-being; possible therapeutic effects
are not based on the transfer or exchange of energy,
?improves the working conditions of personnel,
?provides a pleasant atmosphere.
?Certain lighting elements can serve for communication,
information and entertainment of the patient, e.g. when the
light sail is used as a projection surface for a beamer.
1.3.2 Incorrect Use
Restriction?The AmbientLine lighting system is not suitable for use in
explosive areas.
?The AmbientLine lighting system is not suitable for use in rooms
with inflammable mixtures of anesthetics with air or oxygen or
N20 (nitrous oxide).
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1524523_03 AmbientLine Instruction Manual EN
1 Important Safety Notes 1.3.3 Special Features for Use of the AmbientLine
Lighting System
Visual examination of the patient's condition ?Be aware that the adjusted colors can make the visual examination of the patient's condition difficult.
Psychological stress?The freely configured color settings and scenarios must not be
adjusted in such a way as to cause psychological stress.
?The operating personnel or the person responsible in the
hospital or medical practice shall be solely responsible for
defining the freely configurable color settings and scenarios.
1.3.4 Declaration of Conformity and Approvals
Conformity and EU approvals The device meets the basic requirements of the European Medical
Device Directive 93/42/EEC and has been tested according to
UL60601-1.
1.3.5 Shipping and Storage
The following conditions apply to shipping and storage:
?Temperature: - 15°C to + 60°C
?Relative humidity: 10% to 75%
?Atmospheric pressure: 500hPa to 1060hPa
Furthermore, the values prescribed for ambient conditions must be
adhered to.
1.3.6 Ambient Conditions
?The ambient temperature during operation shall be between
10°C and 40°C.
?The relative humidity shall be in a range between 30 and 75%.
?The atmospheric pressure shall be between 700 and 1060hPa.
1.3.7 Use in Combination with other Medical Devices
?The AmbientLine Lighting System must not be combined with
devices of other manufacturers.
1.3.8 Disposal
?The device must be disposed of at a collection point suitable for
the recycling of electrical and electronic devices in accordance
with country-specific regulations.
RoHS conformity?The device fulfills the requirements of the 2002/95/EC RoHS
directive (restriction of the use of certain hazardous substances
in electrical and electronic equipment) for Device Group 9.
1524523_03 AmbientLine Instruction Manual EN 9
1Important Safety Notes
1.3.9 Structure of the Safety Instructions
Important notes in these Operating Instructions are marked with
graphic symbols and signal words.
Signal words such as DANGER, WARNING or CAUTION describe
the degree of hazard. The different triangle symbols visually
underline the degree of hazard.
1DANGER DANGER refers to an immediately dangerous situation which, if not
avoided, leads to death or severe injury.
1WARNING WARNING refers to a potentially dangerous situation which, if not
avoided, can lead to death or severe injury.
1CAUTION CAUTION refers to a potentially dangerous situation which, if not
avoided, leads to minor or slight injury.
NOTICE NOTICE refers to a potentially dangerous situation which, if not
avoided, leads to damage to property.
NOTE NOTE provides additional information and useful tips for the safe
and efficient use of the device.
10
1524523_03 AmbientLine Instruction Manual EN
1524523_03 AmbientLine Instruction Manual EN 11
1 Important Safety Notes
The following pictograms provide more specific
information on the possible hazard.
Gas explosion: warns of the ignition of explosive mixtures of gases.
Collapse of the light sail: warns of the sudden collapse of the
AmbientLine sail.
Electric shock: warns of electric shock which can lead to
severe injury or even death.
Damage to surfaces: warns of damage to surfaces caused by
improper cleaning agents, disinfectants and methods.
Pictograms on the devices
CE conformity marking: shows conformity with the guidelines of
the European Medical Device Directive (MDD).
Disposal in compliance with applicable regulations: warns of
the disposal of the device in breach of applicable regulations.
1524523_03 AmbientLine Instruction Manual EN
121Important Safety Notes
1.4Overview of the Most Important Safety Instructions
1DANGER
Gas explosion
The AmbientLine Lighting System is not
suitable for use in explosive areas.
The AmbientLine Lighting System is not
suitable for use in environments with
inflammable mixtures of anesthetics and air or
oxygen or N 20 (nitrous oxide).
1WARNING
Electric shock
Contact with energized components can lead
to electric shock. Disconnect the device from
the mains before cleaning or disinfecting it:
?Make sure that all poles are disconnected.
?Secure the device against unintentional start-up.
?Make sure that no cleaning or disinfection agent penetrates the device and the support arm system.
1CAUTION
Collapse of the light sail
Risk of injury to the patient by the collapse of
the light sail:
?Before removing the light sail, the patient must have
left the bed.
?After the replacement of the light sail, check for the
safe positioning of the new light sail.
1 Important Safety Notes
NOTICE
Damage to the device
Cleaning or disinfection agents penetrating the device
can damage optical, electronic or mechanical
components:
?Wipe the device with a moderately moist cloth to clean it.
?Refrain from any other disinfection method than wiping
disinfection.
1524523_03 AmbientLine Instruction Manual EN 13
2Device and Functional Description
2.1Device Description
The AmbientLine Lighting System is operated on the incarePORT /
klinoPORT Ceiling Pendant.
2.1.1 Lighting Units and Light Sail
The AmbientLine Lighting System consists of the following optional
lighting units. The “Figure 1” on Page15 shows the maximum
number of units.
Lighting units in the luminaire case 1:
?AmbientLine Wall2, (RGB colors - Red, Green, Blue),
?AmbientLine Bed4, subdivided into head, central (reading
light) and foot areas (white color).
Sail lighting 5:
?AmbientLine Sail3, (RGB colors - Red, Green, Blue).
Lighting units at the top of the basic pendant 6:
?AmbientLine Floor (white or RGB colors - Red, Green, Blue) on
the basic pendant7
or
?AmbientLine Floor (white or RGB colors - Red, Green, Blue) on
the sub-pendant8.
Lighting units on the support arms 9:
?AmbientLine Ceiling A (white or RGB colors - Red, Green,
Blue).
Lighting units on the operator handle of the platforms C:
AmbientLine Desk D.
2.1.2 Operator Panel
Mounting position The operator panel B can be mounted to different positions in
Pendant or Box version.
The schematic representation illustrates the mounting of the
operator panel B in "Box Operator Panel" version at the top of the
pendant 6.
The operation of the panel B is identical, independent of the
mounting position.
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1524523_03 AmbientLine Instruction Manual EN
2 Device and Functional Description Figure 1
1524523_03 AmbientLine Instruction Manual EN 15
2Device and Functional Description
2.2Functional Description
2.2.1 Operator Panel
The optional lighting units are operated by means of an operator
panel1.
Mounting position The operator panel1 can be mounted to different positions in
Pendant or Box version.
The schematic representation illustrates the mounting of the
operator panel1 in "Box Operator Panel" version at the top of the
pendant 6.
The operation of the operator panel1 is identical, independent of
the mounting position.
Operator panel versions The operator panel1 is configured in two versions for operation in
the Operating Room (OR)2 and in the Intensive Care Unit (ICR)
3.
Configuration versions The schematic representation shows the operator panel1 in
maximum configuration with all lighting options.
In case of configuration with a reduced number of lighting options,
the setting options on the operator panel1 are adapted
accordingly.
2.2.2 Lighting on the Operator Handle of the Platforms
AmbientLine Desk AmbientLine Desk5 is an autonomous lighting unit. It is controlled
by means of a separate ON/OFF switch4 on the operator handle.
Optionally, AmbientLine Desk5 can also be controlled by opening
(switching on) and closing (switching off) a drawer positioned below
this lighting unit.
16
1524523_03 AmbientLine Instruction Manual EN
2 Device and Functional Description Figure 2
1524523_03 AmbientLine Instruction Manual EN 17
3Operation
3.1General Operating Functions
The operator panel versions for OR and ICU areas are identical.
Day/night switching The day/night switching2 reduces the intensity of light of the
operator panel in night mode.
Operating zones:
The operator panel is sub-divided into the operating zones1 to 4:
1Selection of optional lighting units (the photo shows the
maximum configuration),
2adjusting the light intensity by means of the Plus (+) and
Minus (-) keys,
3selection of defined lighting scenarios such as white light D,
4selection of freely configurable color settings and scenarios.
For more detailed information on the configuration of the
color setting, see “Chapter 3.6” on Page22.
3.2Lighting Units for the Operating Room (OR)
4AmbientLine Ceiling - RGB,
5AmbientLine Floor - RGB.
Lighting scenarios for intensity levels 4, 5:
1Emergency button – all lighting units, white light, maximum
lighting intensity.
D White light.
3.3Lighting Units for the Intensive Care Unit (ICU)
6AmbientLine Bed – head area
7AmbientLine Bed – central area
8AmbientLine Bed – head area
9AmbientLine Sail
A AmbientLine Wall
B AmbientLine Ceiling - White
C AmbientLine Floor - White
Lighting scenarios for intensity levels 9, A:
1Emergency button – all lighting units, white light, maximum
lighting intensity.
D White light,
E Automatic day cycle – switches to an automatic day/night
cycle with light colors depending on the time of day.
F Night mode.
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3 Operation Figure 3
1524523_03 AmbientLine Instruction Manual EN 19
3Operation
3.4Operation of the Lighting Units
Be aware that the adjusted colors can make the visual examination
of the patient's condition difficult.
3.4.1 Switching the Operator Panel On and Off
?To switch the operator panel on or off, briefly press the ON/
OFF switch3.
3.4.2 Switching the Lighting On and Off
?To switch off a lighting unit, briefly press the related symbol in
the control area1, e.g. the symbol B for AmbientLine
Ceiling.
?If a lighting unit is switched on, the related symbol is shown in a
bold frame.
3.4.3 Adjusting the Light Intensity
?Briefly press the Plus (+) and Minus (-) keys in the central zone
2 to increase (+) or reduce (-) the light intensity of the
corresponding lighting unit as long as the maximum or
minimum value has not yet been reached.
?This setting can also be performed while the lighting unit is not
switched on, i.e. by way of pre-selection.
3.4.4 Selecting Lighting Scenarios
?To select the desired lighting scenario, briefly press the symbol
in the operating zones3and4, e.g. the symbol E for
automatic day cycle. For more detailed information on the
configuration of the color setting, see “Chapter 3.6” on
Page22.
?This setting can also be performed while the lighting unit is not
switched on, i.e. by way of pre-selection.
3.5Lighting Units on the Operator Handle of the
Platforms
AmbientLine Desk AmbientLine Desk (see “Chapter 2.2” on Page16) is an
autonomous lighting unit. It is controlled by means of a separate
ON/OFF switch on the operator handle.
Optionally, AmbientLine Desk can also be controlled by opening
(switching on) and closing (switching off) a drawer positioned below
this lighting unit.
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