Operating-AmbientLine Lighting System-1524523

Operating Instructions
AmbientLine Lighting System

on the incarePORT / klinoPORT / TruPort Ceiling Support System
Imprint
TRUMPF Medizin Systeme GmbH + Co. KG

Carl-Zeiss-Straße 7-9
D-07318 Saalfeld
Phone: +49 / 36 71 / 586 - 0
Fax: +49 / 36 71 / 586 - 41 105
E-Mail: med@trumpf.com
www.hill-rom.com
www.trumpf-med.com
Thank you very much
for purchasing the new AmbientLine Lighting System. Please read through these ope-
rating instructions carefully and ensure adherence to all safety instructions and requi-
rements regarding the operation and care of the device.
Which devices are covered by this user manual

AmbientLine Lighting System:
• installed on the ceiling support system with incarePORT® / klinoPORT® / TruPort®
ceiling pendants.
The AmbientLinie Operating Instructions are only valid when combined with the Ope-
rating Instructions of the ceiling support systems. You will find all the information in the
following operating instructions:
• Operating Instructions Ceiling support systems.
• Operating Instructions TruPort®.
1524523_06_01 US Operating Instructions AmbientLine | 01.02.2015 3

How to contact us
Customer Service is at your disposal

• if you have any questions on the equipment or its installation,
• if you would like to re-order spare parts,
• for servicing or warranty claims.
Manufacturer and distributor

TRUMPF Medizin Systeme GmbH
07318 Saalfeld
Germany
How to contact us
Benzstrasse 26
D-82178 Puchheim
Germany
Sales Phone:+49 / (0)89 / 8 09 07 - 0

Fax:+49 / (0)89 / 8 09 07 - 40 222
Customer Service Phone:0 180 / 2 25 41 35

Inquiries from Germany Chargeable phone call:
– 6 ct/call from German landline
– 42 ct/minute (max.) from mobile phones
Fax: 0 36 71 / 586 - 41 175
Customer Service Phone: +49 / 36 71/ 586 - 0

Inquiries from abroad Fax: +49 / 36 71 / 586 - 41 175
E-mail service.med@de.trumpf.com
Visit us on the Internet www.trumpf-med.com

Notes relating to this documentation
Copyright and industrial rights

Copyright All rights reserved. These operating instructions are protected by copyright.
• Any use other than that permitted by law must be approved in writing by TRUMPF
Medizin Systeme GmbH + Co. KG, hereafter referred to as "Trumpf Medical".
• Trumpf Medical shall assume no liability whatsoever on the basis of, or in associ-
ation with, the use of said information prohibited in this manner by any person or
company.
Modifications / amendments and translations

Modifications to the device We are constantly engaged in the further development of our products and reserve the
right to make changes to the scope of supply in terms of design, equipment or techno-
logy.
Amendments to the • The contents of these operating instructions are subject to amendment at any time
operating instructions without notice.
• Please keep up to date on the current version of the operating instructions, e.g.
using the Trumpf Medical Online Information System (OIS) at regular intervals.
Translations • The German-language version of these operating instructions shall be binding as
regards translations into foreign languages.
Trademarks
AmbientLine® as well as incarePORT®, klinoPORT® and TruPort® are aregistered
trademarks of Trumpf Medical.
• All other trademarks mentioned in these operating instructions are the sole pro-
perty of the relevant manufacturers.

Table of Contents
1 Important information for safe use ................................................................................ 8

1.1 How to identify the devices ............................................................................................................... 8
1.2 How to identify the operating instructions ......................................................................................... 8
1.3 Identification of target groups ........................................................................................................... 8
1.3.1 Operators ............................................................................................................................................................8
1.3.2 Users...................................................................................................................................................................8
1.3.3 Qualified staff ......................................................................................................................................................8
1.4 Information for operators .................................................................................................................. 9
1.4.1 Commissioning ...................................................................................................................................................9
1.4.2 Availability of the operating instructions..............................................................................................................9
1.4.3 Warranty .............................................................................................................................................................9
1.4.4 Maintenance and repair ......................................................................................................................................9
1.4.5 Service life of the device .....................................................................................................................................9
1.5 Delivery........................................................................................................................................... 10
1.5.1 Damage in transit..............................................................................................................................................10
1.5.2 Address for returns ...........................................................................................................................................10
1.6 Notes for users ............................................................................................................................... 10
1.6.1 Hands-on training..............................................................................................................................................10
1.6.2 Duty of the user to keep himself informed and inspect the device....................................................................10
1.7 Intended purpose of the device ...................................................................................................... 11
1.7.1 Identification......................................................................................................................................................11
1.7.2 Standards and directives ..................................................................................................................................11
1.7.3 Proper use ........................................................................................................................................................11
1.7.4 Incorrect use .....................................................................................................................................................11
1.7.5 Special features for use of the AmbientLine Lighting System...........................................................................12
1.7.6 Contraindication ................................................................................................................................................12
1.8 Ambient conditions for operation and storage ................................................................................ 12
1.8.1 Ambient conditions for operation ......................................................................................................................12
1.8.2 Ambient conditions for storage .........................................................................................................................12
1.9 Use in combination with other medical devices .............................................................................. 12
1.10 Disposal .......................................................................................................................................... 12
2 Safety instructions ..................................................................................................... 13
2.1 Structure of the safety information in these operating instructions ................................................. 13
2.1.1 Identification of risks of injury............................................................................................................................13
2.1.2 Identification of risk of property damage ...........................................................................................................13
2.1.3 Identification of additional information...............................................................................................................13
2.2 Supplementary symbols used in the safety instructions ................................................................. 14
2.3 Symbols on the device ................................................................................................................... 14
2.4 Overview of the most important safety information......................................................................... 15
3 Device and functional Description .............................................................................. 18
3.1 Device description .......................................................................................................................... 18
3.1.1 Lighting units and light sail................................................................................................................................18
3.1.2 Control panel.....................................................................................................................................................18
3.2 Functional Description .................................................................................................................... 20
3.2.1 Control panel functions .....................................................................................................................................20
3.2.2 Lighting on the operator handle of the platforms ..............................................................................................20
4 Start-up ..................................................................................................................... 22
4.1 General operating functions ........................................................................................................... 22
4.2 Lighting units for the operating room (OR) ..................................................................................... 22
4.3 Lighting units for the intensive care unit (ICU)................................................................................ 22

5 Operation .................................................................................................................. 24
5.1 Operation of the lighting units ......................................................................................................... 24
5.1.1 Switching the control panel on and off ..............................................................................................................24
5.1.2 Switching the lighting on and off .......................................................................................................................24
5.1.3 Adjusting the light intensity ...............................................................................................................................24
5.1.4 Selecting lighting scenarios ..............................................................................................................................24
5.2 Lighting units on the operator handle of the platforms ................................................................... 24
5.3 Defining color settings and color scenarios .................................................................................... 26
5.3.1 Calling up the color settings menu....................................................................................................................26
5.3.2 Defining the lighting mode and the color setting ...............................................................................................26
6 Cleaning and Disinfection .......................................................................................... 28

6.1 General ........................................................................................................................................... 28
6.2 Wipe disinfection ............................................................................................................................ 29
6.3 Recommended disinfecting agents ................................................................................................ 30
7 Sterilization................................................................................................................ 31
7.1 Preparation ..................................................................................................................................... 31
7.2 Cleaning and disinfection .............................................................................................................................31
7.2.1 Cleaning............................................................................................................................................................31
7.2.2 Disinfecting .......................................................................................................................................................31
7.3 Sterilization ..................................................................................................................................... 32
7.3.1 General instructions ..........................................................................................................................................32
7.3.2 Steam sterilization.............................................................................................................................................32
7.3.3 Sterilization packaging ......................................................................................................................................33
8 Inspection, maintenance and repairs .......................................................................... 34

8.1 Inspections during operation .......................................................................................................... 34
8.2 Inspection and maintenance intervals ............................................................................................ 35
8.3 Replacement of parts subject to wear ............................................................................................ 35
9 Removing / replacing the light sail .............................................................................. 36
9.1 Removing the light sail ................................................................................................................... 36
9.2 Replacing the canvas ..................................................................................................................... 36
9.3 Inserting the light sail ...................................................................................................................... 38
10 Technical data ........................................................................................................... 40
10.1 Device data..................................................................................................................................... 40
10.2 Electromagnetic Compatibility (EMC) ............................................................................................. 42

1 Important information for safe use
1.1 How to identify the devices
These operating instructions are intended solely for devices with the manufacturer's
identification plate bearing the following information:
Device identification – Device designation: Lighting System

– Model designation: AmbientLine
– Devices upwards of serial number: 100 728 150
1.2 How to identify the operating instructions
Make sure you have the latest version To ensure that you always have the latest version of these operating instructions, all
pages bear a 7-digit identity number with 4-digit version number and country code.
Operating Instructions identification – Edition: 1524523_06_01 US

– Dated: 01.02.2015
This identification is binding for the validity of the operating instructions and must not be
removed, regardless of the type of publication (printed form, electronic form or excerpts).
1.3 Identification of target groups
These operating instructions refer to the following groups.
1.3.1 Operators
An operator (e.g. doctors' surgeries, hospitals, etc.) is any individual person or legal
entity that owns and operates the device or on whose behalf the device is operated.
• The operator is obliged to provide a safe device and to instruct the user adequately
in the operation of the device and its intended use.
1.3.2 Users
Users are persons who, due to their qualifications or the appropriate training by quali-
fied staff, are entitled to operate and work with the device.
• Users are fully responsible for the safe operation of the device and for ensuring that
it is only used for its intended purpose.
1.3.3 Qualified staff

Qualified staff are authorised persons who are generally employees of the operator
and:
• have acquired their skills through professional training in the medical sector,
• can assess their job and recognise the potential hazards involved on the basis of
their professional experience and instruction in the safety-relevant regulations.
• In states where having a profession in the medical sector requires a certificate, the
classification as qualified staff assumes the appropriate certification.

1.4 Information for operators
Procedural guidelines The device is designed according to state-of-the-art technology and is safe to operate.
• However, use of this appliance may still constitute a hazard. In particular if it is
used by staff without sufficient training or if not used properly and in accordance
with its intended purpose.
• The device may only be operated, cleaned, disinfected and maintained by qualified
staff.
1.4.1 Commissioning
Validity Upon initial commissioning, the lighting system must be subjected to extensive tests by
the installer's service personnel prior to handover to the operator.
• To this end, the operator must be duly instructed with regard to functional and
visual inspections, adjustment work, cleaning and care of the device in accordance
with the applicable Operating Instructions.
• The device must be handed over for operation with confirmation in writing issued
by the operator.
• As soon as the device has been released for operation, the instructions provided in
these Operating Instructions are binding for the user.
1.4.2 Availability of the operating instructions

Duty to supply information The operating instructions are an integral part of the device and must be kept in a
convenient place close to the device as a ready reference for safety instructions and
other important information when required.
• Please do not pass on the device to third parties without the operating instructions.
Using the identity number and version number as a reference, ensure that up-to-
date and valid operating instructions are supplied with the device.
1.4.3 Warranty
Warranty Trumpf Medical guarantees the safety and functionality of the device only on condition
that:
• the device is used solely for the intended purpose and operated and repaired
according to the information specified in this user manual,
• only original spare parts and accessories specifically authorised by Trumpf
Medical are used,
• no structural modifications are made to the device,
• servicing is carried out at the specified intervals,
• the device is correctly commissioned and released for operation with a commissi-
oning declaration.
1.4.4 Maintenance and repair

Maintenance and repair work on this device or on parts thereof must be carried out by:
• Trumpf Medical aftersales service,
• authorized service companies trained by Trumpf Medical,
• operator service personnel which has been trained and authorized by Trumpf
Medical.
1.4.5 Service life of the device

Provided that all applicable safety and maintenance instructions are strictly adhered to,
Trumpf Medical products are designed for a service life of 10 years.
• This service life includes warranty of product functionality in accordance with the
specifications in the Operating Instructions, the provision of service and also spare
parts supply.
• Trumpf Medical applies a quality management system certified in accordance with

DIN EN ISO 13485 standard to all of its corporate processes.

• This ensures:
– top quality,
– convenient operation,
– functional design,
– optimization for the intended use.
1.5 Delivery
Prior to installation, inspect the delivered components for completeness and damage
that may have occurred in transit.
• To inspect the delivery, all components must be unpacked and subjected to visual
inspection.
• The components can be identified by means of the order number indicated on the
shipping note and /or the order-specific dimension sheet.
1.5.1 Damage in transit

Damage claims Damage claims can only be considered if Trumpf Medical is notified immediately. In
case of damage in transit or shortages, a damage report including the following infor-
mation must be forwarded to Trumpf Medical:
Accompanying documents • Damage report providing information on the damages or defects
• Main serial number of the device/system or serial numbers of the damaged com-
ponents
• Order number (as specified on the shipping note and/or order-specific dimension
sheet)
• Name and address of customer
• Consignee
1.5.2 Address for returns

Returns To return an item, use the original packaging if possible.
Returns must be sent to the following address:
D-07318 Saalfeld
Germany
1.6 Notes for users
Please note that the device may only be used by personnel who have been trained to
use it.
1.6.1 Hands-on training

Training • All training must be hands-on at the device and carried out by qualified staff of the
operator or by the installation engineer authorised by the manufacturer.
• On completion of the training, it must be documented in an instruction report that
the user has understood the special operating measures required for correct use of
the device for its intended purpose.
1.6.2 Duty of the user to keep himself informed and inspect the device
Troubleshooting • Please ensure you have thoroughly read these operating instructions before using
the device for the first time. This allows you to maximise all the advantages offered
by the device and helps prevent injuries and damage to the device.

• The user must check that the device is fully functional and in perfect condition
before each use.
• If you encounter specific problems not covered in sufficient detail by these opera-
ting instructions, please contact your supplier for your own safety.
1.7 Intended purpose of the device
1.7.1 Identification
Conformity The manufacturer declares that this product conforms to the fundamental requirements
according to MDD Appendix I and documents this by means of the CE and UL mark.
CE conformity mark: This item of equipment is a Class I medical device as defined by

the European Medical Device Directive.
UR marking: This device has been tested by Underwriter Laboratories Inc. for use in
the USA and Canada. UL/cUL classification regarding electric shock and fire hazard
and mechanical hazards.
1.7.2 Standards and directives

The device complies with the safety requirements of the following standards and direc-
tives:
• MDD 93/42/EWG, 2007 - Medical Product Directive;
(Medical Device Directive MDD 93/42/EWG, 2007, Appendix IX);
• EN 60601-1: 2006 (IEC 60601-1: 2005) - Medical Electrical
Equipment: General Requirements for Basic Safety and Ergonomic Design;
• EN 60601-1-2:2007 (IEC 60601-1-2: 2007) - Medical
Electrical Equipment - Electromagnetic Compatibility;
• EN ISO 11197: 2009 Medical Supply Units;
• EMC Directive 2014/30/EU - Electromagnetic Compatibility
(of Electrical and Electronic Equipment) for measurement,
control and laboratory use.
UL/cUL classification:
• UL 60601-1, 1st Edition, 2006-04-26
• CAN/CSA C22.2 Nr. 601.1 - M 90, 2005;
1.7.3 Proper use

Proper use The AmbientLine Lighting System:
• is an accessory to the incarePORT® / klinoPORT® and TruPort® ceiling support
system,
• 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 entertain-
ment of the patient, e.g. when the light sail is used as a projection surface for a
beamer.
1.7.4 Incorrect use

Incorrect Use The AmbientLine Lighting System must not be used in rooms with inflammable
mixtures of anesthetics with air, oxygen or nitrous oxide.

• In the environment of the device, mixtures of inflammable anesthetic vapors with

oxygen or nitrous oxide can occur in such high concentrations that there is a risk of
ignition under certain conditions. In accordance with EN 11197, the hazardous
area includes an area between 5 cm and 25 cm from the gas leak point.
• The device must not be used near strong magnetic fields.
1.7.5 Special features for use of the AmbientLine Lighting System

Visual examination of Be aware that the adjusted colors can make the visual examination of the patient's
the patient's condition 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 prac-
tice shall be solely responsible for defining the freely configurable color settings
and scenarios.
1.7.6 Contraindication
No contraindication has been identified.
1.8 Ambient conditions for operation and storage
Different conditions are required for the operation and interim storage of the device.
1.8.1 Ambient conditions for operation

• Ambient temperature: 10°C to 40°C;
• Relative humidity: 30% to 75%;
• Air pressure: 700 hPa to 1060 hPa,
• Operating altitude up to 3,000 m a.s.l.
1.8.2 Ambient conditions for storage

• Ambient temperature: -15°C to 60°C;
• Relative humidity: 5% to 95%;
• Air pressure: 500 hPa to 1060 hPa.
1.9 Use in combination with other medical devices
The AmbientLine® Lighting System must not be combined with devices of other manu-
facturers.
1.10 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 equipment).

2 Safety instructions
2.1 Structure of the safety information in these

operating instructions
In these operating instructions, important safety information is indicated by symbols

and signal words.
2.1.1 Identification of risks of injury

Signal words such as DANGER, WARNING or CAUTION identify the severity of the risk
of injury. The different triangle symbols visually emphasise the degree of danger.
DANGER indicates an immediate hazard, which, if not avoided, will cause death or
 DANGER
serious injury.
 WARNING WARNING indicates a potential hazard, which, if not avoided, may cause death or
serious injury.
 CAUTION CAUTION indicates a potential hazard, which, if not avoided, will cause minor or slight
injury.
2.1.2 Identification of risk of property damage
NOTICE NOTICE indicates a potential hazard, which, if not avoided, will cause damage to
property.
2.1.3 Identification of additional information
NOTE NOTE gives you additional information and helpful tips for the safe and efficient use of
the device.

2.2 Supplementary symbols used in the safety instructions
Gas explosion: warns of the danger of the explosive ignition of gas mixtures.
Electric shock: warns of an electric shock which may result in severe or even fatal
injury.
Collapse of the light sail: warns of the sudden collapse of the sail.
Damage to surfaces: warns of the risk of damage to the surfaces through the use of
incorrect cleaning agents or disinfectants.
2.3 Symbols on the device
CE conformity mark: confirms conformity of the device to the guidelines of the Euro-
pean Medical Device Directive (MDD).
The UR mark confirms that the device has been tested by Underwriter Laboratories
Inc. for use in the USA and Canada. The UL/cUL classification with respect to electric
shock, fire and mechanical hazards.
Observe the Instrucciones de uso: refers to these Instrucciones de uso.

2.4 Overview of the most important safety information
Location requirements
 DANGER
Gas explosion
When in contact with oxygen in the air, medical

gases can form an explosive or easily inflammable gas
mixture.
The lighting system is not suitable for use in environments with inflamma-
ble mixtures of anesthetics with high concentrations of oxygen or nitrous
oxide.
In accordance with EN 11197, the hazardous area includes an area bet-
ween 5 cm and 25 cm from the gas leak point.
Electric shock
 WARNING
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.
Electrostatic charge compensation
 WARNING
Complications due to charge compensation
To avoid complications due to electrostatic charge compensation between

device parts and patients, the user must not touch the examination light
and the patient at the same time.
Additional loads
 WARNING
Lighting system dropping
Do not place additional loads on the lighting system.

Replace of the light sail
 CAUTION
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.
Cleaning and disinfection
 WARNING
Improperly used cleaning and disinfecting agents can endanger patients
or damage products.
Non-compliance with the specifications and directions in this chapter can

lead to risk of contamination and infection for patients or damage pro-
ducts. It also completely voids the warranty.
• Refrain from any other disinfection method than wiping disinfection.
• The cloth used to clean / disinfect the device should only be damp, not
wet.
• Dose cleaning agents/disinfectants such that no fluid can enter into the
joints or openings of the OR lights or parts of the pendant system.
• Use surface disinfectants only in the concentration specified by the ma-
nufacturer.
• Use only disinfectants approved by the manufacturer for use on the fol-
lowing materials:
Polycarbonate (PC), polyamide (PA), acrylonitrile-butadiene-styrene
copolymer (ABS), polystyrene (PS), polyurethane (PUR), polyphenyl-
sulfone (PPSU), polyethylene terephthalate (PET), and silicones.
• In the event of increased build-up of surface disinfectant, conduct a tho-
rough basic cleaning.
• To avoid damage to surfaces:
- do not use sharp, pointed or abrasive objects;
- do not use abrasives or agents that strip away material;
- do not use solvents, gasoline, paint thinners, or alkaline, acidic or al-
dehyde-containing cleaning agents;
- do not use cleaning agents with glycol derivatives, phenols, phenol
derivatives or quarternary compounds;
- use only agents without chloride or halogenides to avoid damage to
paint and corrosion.
• Comply with the operator's hygiene guidelineseaning and disinfection
NOTICE
Damage to surfaces / lacquered surfaces
Solvents can destroy paint and plastic materials. To prevent

damage:
• Only use agents without chlorides, halogenides, glycol derivatives, phe-
nols or phenol derivatives and quaternary compounds.

• Do not use any petrol, paint thinners or cleaning agents containing alka-
line, acidic or aldehyde substances.
• Do not apply any scrubbing agents or agents with an abrasive effect.
Maintenance
 CAUTION
Performing adjustment work
The manufacturer guarantees the safety and functional reliability of the

device only on condition that mounting and adjustment work is carried out
by an authorized hospital technician or a person with comparable
qualification.
--------------------------------------------------------------------------------------------------
Warranty
The safety, reliability and performance of the device can only be guaran-
teed if genuine Trumpf Medical spare parts or parts approved as suitable
by Trumpf Medical are used exclusively.
Risk of collision
 CAUTION
Risk of collision
Collisions mit ceiling support systems or other devices must be prevented.
Commissioning
 CAUTION
Initial start-up prior to operation
Before using the ceiling support unit (CSS) during medical operation, an
initial start-up must be carried out and the CSS must be handed over to
the operator following inspection.
• The initial start-up includes functional and safety tests of the entire
ceiling support unit (CSS).
• Acceptance shall be documented by means of a declaration of accep-
tance.

3 Device and functional Description
3.1 Device description
The AmbientLine Lighting System serves as accessories to the incarePORT /

klinoPORT and TruPort ceiling support system.
3.1.1 Lighting units and light sail

The AmbientLine® Lighting System consists of the following optional lighting units. The
Figure 1 shows the maximum number of units.
Lighting units in the luminaire case 1 :

• AmbientLine Wall 2 , (RGB colors - Red, Green, Blue),
• AmbientLine Bed 4 , subdivided into head, central (reading light) and foot areas
(white color).
Sail lighting 5 :
• AmbientLine Sail 3 , (RGB colors - Red, Green, Blue).
Lighting units at the top of the basic pendant 6 :

• AmbientLine Floor 7 (white or RGB colors - Red, Green, Blue) on the basic
pendant 6.
or
• AmbientLine Floor 7 (white or RGB colors - Red, Green, Blue) on the sub-pen-
dant 8 .
Lighting units on the swivel-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 .
3.1.2 Control panel

Mounting position The control panel B can be mounted to different positions in Pendant or Box version.
The schematic representation illustrates the mounting of the control panel B in "Box
control panel" version at the top of the pendant 6 .
The operation of the panel B is identical, independent of the mounting position.

Figure 1

3.2 Functional Description
3.2.1 Control panel functions

The optional lighting units are operated by means of an control panel 1 .
Mounting position The control panel 1 can be mounted to different positions in Pendant or Box version.
The schematic representation illustrates the mounting of the control panel 1 in "Box
control panel" version at the top of the pendant 6 .
The operation of the control panel 1 is identical, independent of the mounting position.
Control panel versions The control panel 1 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 control panel 1 in maximum configuration
with all lighting options.
In case of configuration with a reduced number of lighting options, the setting options
on the control panel 1 are adapted accordingly.
3.2.2 Lighting on the operator handle of the platforms

AmbientLine Desk AmbientLine Desk 5 is an autonomous lighting unit. It is controlled by means of a
separate ON/OFF switch 4 on the operator handle.
Optionally, AmbientLine Desk 5 can also be controlled by opening (switching on) and
closing (switching off) a drawer positioned below this lighting unit.

Figure 2
6
2
5
4
3

4 Start-up
4.1 General operating functions
The control panel versions for OR and ICU areas are identical.
Day/night switching The day/night switching 2 reduces the intensity of light of the control panel in night
mode.
Operating zones:
The control panel is sub-divided into the operating zones 1 to 4:
1 Selection of optional lighting units (the photo shows the maximum configuration),
2 adjusting the light intensity by means of the Plus (+) and Minus (-) keys,
3 selection of defined lighting scenarios such as white light D ,
4 selection of freely configurable color settings and scenarios. For more detailed
information on the configuration of the color setting, see Chap. 5.3, page 26.
4.2 Lighting units for the operating room (OR)
1 AmbientLine Ceiling - RGB,

5 AmbientLine Floor - RGB.
Lighting scenarios for intensity levels 4 , 5 :

1 Emergency button – all lighting units, white light, maximum lighting intensity.
D White light.
4.3 Lighting units for the intensive care unit (ICU)
6 AmbientLine Bed – head area

7 AmbientLine Bed – central area
8 AmbientLine Bed – head area
9 AmbientLine Sail
A AmbientLine Wall
B AmbientLine Ceiling - White
C AmbientLine Floor - White
Lighting scenarios for intensity levels 9 , A :

1 Emergency 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.

4 Start-up
Figure 3
1 2 3
1 2 4
4
1 2 3
1 2 4
6
D E F

5 Operation
5.1 Operation of the lighting units
Be aware that the adjusted colors can make the visual examination of the patient's
condition difficult.
5.1.1 Switching the control panel on and off

• To switch the control panel on or off, briefly press the ON/OFF switch 3 .
5.1.2 Switching the lighting on and off

• To switch off a lighting unit, briefly press the related symbol in the control area 1,
e.g. the symbol B for AmbientLine Ceiling.
➥ If a lighting unit is switched on, the related symbol is shown in a bold frame.
5.1.3 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.
5.1.4 Selecting lighting scenarios

• To select the desired lighting scenario, briefly press the symbol in the operating
zones 3 and 4, e.g. the symbol E for automatic day cycle. For more detailed
information on the configuration of the color setting, see Chap. 5.3, page 26.
• This setting can also be performed while the lighting unit is not switched on, i.e. by
way of pre-selection.
5.2 Lighting units on the operator handle of the platforms
AmbientLine Desk AmbientLine Desk is an autonomous lighting unit. It is controlled by means of a sepa-
rate 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.

5 Operation
Figure 4
1 2 3
1 2 4
4
1 2 3
1 2 4
6
D E F

5 Operation
5.3 Defining color settings and color scenarios
You can freely configure color settings for AmbientLine lighting units with different
colors (RGB - Red, Green, Blue). The settings of the control panel versions for the OR
and ICU areas are identical.
5.3.1 Calling up the color settings menu

1. Press the Trumpf Medical Logo 1 three times.
➥ The menu  pops up.
• To exit the menu , press the Exit button 3 .
2. Press the Color Setting key 2 .

➥ The menu  pops up.
As examples for installed AmbientLine lighting units, Figure 5 shows the Ambi-
entLine Sail 9 and the AmbientLine Wall A .
If additional AmbientLine lighting units with colored light (RGB - Red, Green,
Blue) are installed, these are displayed as well.
• To exit the menu , press the key 8 .
5.3.2 Defining the lighting mode and the color setting

1. Select the desired lighting mode by briefly pressing a symbol in the operating
zone 1, e.g. symbol 4 for the night mode of the AmbientLine Sail.
➥ The menu  pops up.
➥ The currently selected color setting is shown in the operating zone 2.
2. Briefly press the Plus (+) and Minus (-) keys in the operating zone 3 to modify
the color setting of the corresponding lighting unit as long as the maximum or mi-
nimum value has not yet been reached.
• Key 7 = save new setting.
• Key 6 = restore the previous color setting if the setting has not yet been saved.
• Key 5 = restore factory settings.
• exit key 8 = opens menu .
3. exit key 8 = opens menu .

4. To exit the menu , press the exit key 3 .

5 Operation
Figure 5
1 2 3
4 5 6 7 8
4 5 6 7 8

6 Cleaning and Disinfection
To ensure safe operation, your lighting system must be cleaned and disinfected using
suitable cleaning agents / disinfectants at regular intervals.
 WARNING
Electric shock hazard
Contact with energized components can lead to electric

shock.
• Disconnect the device from the power supply at all poles before
cleaning or disinfecting it:
• Make sure that no cleaning or disinfection agent penetrates the device
and the pendant system.
• Do not insert any object into the device openings.
 WARNING
Improperly used cleaning and disinfecting agents can endanger patients
or damage products.
Non-compliance with the specifications and directions in this chapter can

lead to risk of contamination and infection for patients or damage pro-
ducts. It also completely voids the warranty.
• Dose cleaning agents/disinfectants such that no fluid can enter into the
joints or openings of the OR lights or parts of the pendant system.
• Use surface disinfectants only in the concentration specified by the ma-
nufacturer.
• Use only disinfectants approved by the manufacturer for use on the fol-
lowing materials:
Polycarbonate (PC), polyamide (PA), acrylonitrile-butadiene-styrene
copolymer (ABS), polystyrene (PS), polyurethane (PUR), polyphenyl-
sulfone (PPSU), polyethylene terephthalate (PET), and silicones.
• In the event of increased build-up of surface disinfectant, conduct a tho-
rough basic cleaning.
• To avoid damage to surfaces:
do not use sharp, pointed or abrasive objects;
do not use abrasives or agents that strip away material;
do not use solvents, gasoline, paint thinners, or alkaline, acidic or
aldehyde-containing cleaning agents;
do not use cleaning agents with glycol derivatives, phenols, phenol
derivatives or quarternary compounds;
use only agents without chloride or halogenides to avoid damage to
paint and corrosion.
• Comply with the operator's hygiene guidelines.
6.1 General
To be performed by hygiene specialists Only a hygiene specialists or those instructed by them may clean and disinfect the OR
lights.
Use only approved cleaning and disinfecting Only those agents or chemicals compatibility-tested and approved by Trumpf Medical
agents may be used for cleaning and disinfecting as specified in Chap. 6.3, page 30. Do not
use agents that are not listed, otherwise functional components may be altered or
damaged.

Basic cleaning prior to disinfection Before the actual disinfection, thoroughly clean any visible impurities such as bodily
fluids.
• Do not use any sharp, pointed or abrasive objects, abrasives or stripping agents,
otherwise surfaces may be damaged.
• Chemical substances could infiltrate and destroy damaged surfaces.
• To clean heavy or stubborn soil, use only a soft brush and mild cleaner or cleaning
disinfectant. Disinfection can take place once all the visible contaminants have
been removed.
Wipe disinfection only Use only a wipe-down disinfectant to disinfect the device. Disinfection using UV light or
steam is prohibited.
NOTE
Warranty
Non-compliance with cleaning and disinfection specifications voids all war-

ranty claims. No liability is assumed for damage caused by cleaning/disin-
fecting with inappropriate cleaning/disinfecting agents.
--------------------------------------------------------------------------------------------------
The warranty is valid only for undamaged surfaces.
6.2 Wipe disinfection
A wipe-down disinfectant is to be used to disinfect the lights head and pendant

systems. The light head must be cool for cleaning and disinfection.
Wipe with moist cloth only To clean and disinfect the components of the device, wipe them with a damp but not
wet cloth. Apply only a thin liquid film, wipe, and leave behind only a thin, cohesive film
of moisture. This moist film has sufficient microbiological effect. The fluid does not need
to remain on the surface.
Avoid build-up Applying too much fluid to the surface during disinfection leaves behind residue. To
prevent build-up of disinfectant residue, a mild all-purpose cleaner should be used for
regular cleaning.
Clean at least once per month How often to clean depends on how often disinfectant is used, but at least once a
month is mandatory.
Clean OR lights only with a damp but not wet cloth.
Cleaning procedure 1. Disconnect the power supply unit from the power supply socket.
2. Wait until the light head has cooled down. Clean / disinfect the light head only
when cooled down.
3. Moisten a cloth with some cleaning or disinfecting agent. Wipe the OR lights using
the moist, not wet, cloth.
 WARNING
Risk of fire or explosion due to disinfectants
Flammable or explosive atmospheres may arise when hand-

ling cleaning and disinfecting agents due to the occurrence of
gases, vapors or mists.
• Do not use any highly flammable disinfecting agents.
• Do not perform any large-scale disinfections.

• Allow hot surfaces to cool prior to disinfection.

• Completely disconnect the electrical installations in the room, where
possible, and ensure that no switching can take place while disinfecting,
especially automatically.
• After wiping with disinfectant, wait until the disinfecting agent is comple-
tely dry.
• Ensure that the room is adequately ventilated.
NOTE
Follow national directives
The operator must meet the requirements of the national hygiene and dis-
infection committee.
6.3 Recommended disinfecting agents
Trumpf Medical recommends for following disinfecting agents for manual use:
Manufacturer Product name

B. Braun Melsungen AG Meliseptol
Miscellaneous 70% 2-propanol alcohol
Schülke & Mayr GmbH Perform 0.5%
Bode Chemie GmbH & Co. KG Dismozon pur 0.75%
Hydrogen peroxide cleaner disinfectant
Clorox Healthcare
wipes
Kesla Pharma Wofasteril 0,5%
• The list of the approved disinfectants is constantly updated and can be found in the
"Instruction Manual Supplement - OR Lights: Cleaning, disinfection & sterilization
", which can be downloaded from the OIS.

7 Sterilization
Material The handles are made of polyphenylsulfone (PPSU), a heat-resistant, shock-resistant plastic.
NOTE
Warranty
Non-compliance with sterilization specifications voids all warranty claims.
No liability is assumed for damage caused by use of inappropriate sterili-

zation methods.
--------------------------------------------------------------------------------------------------
Follow national directives
The operator must meet the requirements of the national hygiene and dis-
infection committee.
7.1 Preparation
– Remove any surface dirt on the OR light with a disposable cloth or paper towel.
– Remove heavy soil on the handle immediately after use (within 2 hours).
– For later cleaning, store the handle in a retaining device where the soil will
remain moist.
– Avoid situations that soil the inner surface of the handle or scratch the cover
plate.
7.2 Cleaning and disinfection
NOTE
Sterilization errors damage products
Non-compliance with the following specifications and instructions can

cause damage to products. It also completely voids the warranty.
• Do not use hot-air sterilization for handles.
7.2.1 Cleaning
The handles can be cleaned using mildly alkaline cleaning agents that do not contain
active chlorine. Trumpf Medical recommends a 0.5% (5ml/L) concentration of
neodisher mediClean (forte).
1. Remove handle from handle adapter.

2. Clean handle with cleaning agent.
3. Rinse off cleaning agent thoroughly with water.
7.2.2 Disinfecting
Use a wipe-down or spray disinfectant. Trumpf Medical recommends products with an
alcohol or aldehyde base that are approved by the manufacturer for use on PPSU.
4. Disinfect the handle.
5. Check the handle for material damage, tears, or deformations and replace if
damaged.
6. Check that the cover plate (if present) is seated securely and replace handle if ne-
cessary.

7 Sterilization
A machine washer-disinfector process in accordance with DIN EN ISO 15883-1 should

be used for cleaning/disinfection. The effectiveness of the process used must always
be approved (e.g., included in the list of tested and approved disinfecting agents and
processes by the Robert Koch Institute/DGHM) and previously generally validated.
If another process is used (e.g., manual), its effectiveness must be proven through vali-
dation.
For machine cleaning, the Vario-TD standard cleaning program from Miele can be
used, or other programs that adhere to the following time and temperature values:
Phase Temperatur Zeit

Prerinsing 20 °C 60 sec.
Cleaning 20 - 55 °C 300 sec.
Neutralization 24 - 55 °C 60 sec.
Interim rinsing 20 - 24 °C 60 sec.
Disinfecting 93 °C 300 sec.
Drying 100 °C 25 min.
7.3 Sterilization
7.3.1 General instructions

• Sterilization processes must be validated per DIN EN SO 17665-1 and
DIN EN SO 17665-2;
• use only fractionated prevacuum;
• not exceed temperatures of 135 °C.
 WARNING
Risk of contamination and infection of the patient
After sterilization, check handles for material damage, tears or deforma-

tions; flaking particles can fall into wounds.
• Immediately replace handles that are damaged, have undergone a ma-
ximum of 350 steam sterilization cycles, or are older than 1.5 years.
7.3.2 Steam sterilization

Handles can undergo up to 350 steam sterilization cycles without damage as long as
the following requirements are met:
• Position handles upright with the open side down, making sure that the plate of the
ALC or camera handles are not sitting directly on the rinsing device (danger of
scratching).
• Sterilize handles individually in packaging suitable for steam sterilization.
• The sterilization packaging has to be large enough for the handle without placing
any tension on the seal.
• If sterilizing more than one handle in one sterilization cycle, do not exceed the
maximum load of the sterilizer.

7 Sterilization
Steam sterilization at 132 °C (270 °F):

• Sterilization time = 4 minutes
• Drying time = 20 minutes
Steam sterilization at 135 °C (275 °F):

• Sterilization time = 3 minutes
• Drying time = min. 16 minutes
7.3.3 Sterilization packaging

The handles are placed in suitable sterilization packaging (disposable sterilization
package, e.g., foil/paper sterilization pouches; single or double packaging per DIN EN
ISO 11607, suitable for steam sterilization) and then sterilized.
7. Place precleaned and disinfected handle in sterilization packaging.
8. Sterilize handle according to specifications.
9. Check the sterilized handle for material damage, tears, or deformations and
replace if damaged.
10.Check that the cover plate (if present) is seated securely and replace handle if
necessary.

8 Inspection, maintenance and repairs
Since each device is subjected to wear and tear over time, the safety and proper func-
tioning of your device must be checked at regular inspection and maintenance inter-
vals. Carry out the repeat inspections in accordance with the specifications on inspec-
tion and maintenance intervals and your national regulations.
We recommend that you sign a service contract.
Customer Service
Customer Service Phone:0 180 / 2 25 41 35
Inquiries from Germany Chargeable phone call:
6 ct/call from German landline
42 ct/minute (max.) from mobile phones
Fax: 0 36 71 / 586 - 41 175
Customer Service Phone: +49 / 36 71/ 586 - 0

Inquiries from abroad Fax: +49 / 36 71 / 586 - 41 175
E-Mail service.med@de.trumpf.com
8.1 Inspections during operation
Weekly inspection Prior to any use of the lighting system for medical operation, a functional test and a
visional inspection must be performed once a week.
 WARNING
Risk of contamination and infection of patients
Loose or damaged parts may fall into wounds. Thus, to ensure the pati-
ent?s safety, check the components of the lighting system for the following
before each use:
• loose parts at the sail, luminaire case and the lighting units,
• visible damage on paints, metal and plastic parts in particular.
--------------------------------------------------------------------------------------------------
Functional test
Prior to any use, perform a functional test on the following functional units:
• Lighting units,
• Control box
--------------------------------------------------------------------------------------------------
Defective devices
Defective devices and functional units must be marked immediately and

put out of operation.
• In case of damage or faults, please contact Trumpf Medical aftersales
service or your authorized service partner immediately.

8 Inspection, maintenance and repairs
8.2 Inspection and maintenance intervals
Annual inspection Annual inspection by the user or operator

Visual inspections and functional tests of the components and functional systems
mentioned above must be performed by the user or operator.
Component / functional system Test

Sail:
Fixing the light sail in the two latches Visual inspection
Control panel:
Surface damage Visual inspection
Control buttons Functional test
Lighting units
AmbientLine Wall / Bed / Sail

Lighting units - luminaire case:
Visual inspection
Surface damage
Functional test
Lighting
AmbientLine Ceiling
Lighting units - lower swivel-arms:
Visual inspection
Surface damage
Functional test
Lighting
AmbientLine Floor
Lighting uits - system head/sub-pendant:
Surface damage Visual inspection
Lighting Functional test
AmbientLine Desk
Lighting units - platform operator handle:
Visual inspection
Surface damage
Functional test
Lighting
8.3 Replacement of parts subject to wear
Replacement after 10 years Repair work of the technical service after 10 years
The LEDs of the lighting units of the entire lighting system must be replaced every 10
years.

9 Removing / replacing the light sail
The light sail 3 can be removed for cleaning or replacing the luminaire case.
Two persons are required to remove the light sail.
9.1 Removing the light sail
 CAUTION
Risk of injury to the patient in bed by the collapse of the light

sail:
• Before removing the light sail, the patient must have left the bed.
• After replacing the light sail, check for the safe positioning of the new light
sail.
1. Using the handle, push down the luminaire case 1 to the limit stop.
➥ The luminaire case 1 snaps into place at the lower end and can no longer be
pushed upwards.
NOTICE
Damage to the light sail
Two persons are required to remove the light sail.
2. Two persons hold one opposite end each of the light sail 3 by the two latches
5.
3. On the upper side of the light sail, simultaneously press the pushbutton 4 on the
two latches 5 . The light sail 3 may then be removed evenly towards the front.
9.2 Replacing the canvas
4. Unzip the canvas 3 and remove it from the front.
NOTICE
Damage to the canvas
Do not crumple or fold the new canvas.
5. Insert the new canvas into the frame and close the zip fastener.
6. Check for the safe positioning of the canvas in the frame.
7. Insert the light sail 3 .

Figure 6

9.3 Inserting the light sail
1. Insert the light sail 3 from the front and make sure to distribute it evenly.
Carefully push it into the two latches until the bolt 6 pushes the pushbutton 4 of
the latches 5 upwards.
➥ In order to ensure that the light sail 3 snaps safely into place, the pushbuttons
4 must protrude from the two latches 5 .
 CAUTION
Risk of injury to the patient by the collapse of the light sail:

•After replacing the light sail 3 , check for the safe positioning
of the new light sail 3 .
2. Check for the correct positioning of the light sail 3 in the frame.
➥ The light sail 3 can no longer be removed from the sail holder.
3. Using the handle, push down the luminaire case 1 to the limit stop (approx. 2 to
3 mm). Next, push and hold down the unlatching knob 2 on the luminaire case
1.
➥ The luminaire case 1 unlatches.
4. Using the handle, push up the luminaire case 1 to the limit stop. The unlatching
knob 2 can be released after approximately 5 cm of stroke.

Figure 7

10 Technical data
10.1 Device data
Electrical Data – General Data

Power supply 85 … 265 V AC
Voltage frequency 47 … 63 Hz
Rated output basic module floor/ceiling 300 W max.
Rated output basic module bed 600 W max
Classification (according to MPG) I
Conformity mark CE, UL
Electrical Data – Components Data

AmbientLine Floor – White
Rated output (350 mA) 4 x 1.1 W
Power consumption <7W
Effective service life of the illuminant (LED) > 20.000 h
AmbientLine Floor – RGB

8 x 1.1 W
Power consumption < 20 W
AmbientLine Ceiling – White

AmbientLine Ceiling – RGB

16 x 1.1 W

10 Technical data
Electrical Data – Components Data

AmbientLine Desk
Rated output (350 mA) 1.1 W
Power consumption <3W
AmbientLine Bed
AmbientLine Wall
16 x 1.1 W
AmbientLine Sail
32 x 1.3 W
32 x 1.2 W
Control panel, Pendant version

Control panel, Box version

Light Data – AmbientLine Bed Daten

Maintenance value of the mean light intensity Em in accordance with EN 12464-1
>= 1.000 Lux
"Lighting of Work Places" for health institutions
Lighting field adjustable along the bed axle > 500 mm / 19.7 inch
Mechanical Data – AmbientLine Sail Daten

approx. 1.100 mm x 1.950 mm /
Light sail dimensions (width x length)
43.3 in x 76.8 inch

10 Technical data
10.2 Electromagnetic Compatibility (EMC)
EMC information
The Lighting System has been designed for operation under the environmental conditions described below. The customer and the
user of the device should ensure these ambient conditions are fulfilled during operation.
Emitted interference measurements Conformity Description

The Lighting System uses HF energy exclusively
for its internal FUNCTION. For this reason, HF
HF interference in accordance with CISPR 11 Group 1
interference is particularly low, and adjacent
devices are not likely to be disturbed.
HF interference in accordance with CISPR 11 Class A
The Lighting System is suitable for use in envi-
Limits for harmonic current emissions in accordance ronments other than living areas and for areas
Class A
with IEC 61000-3-2 which are directly connected to the PUBLIC
POWER SUPPLY NETWORK which also sup-
Limits for harmonic current emissions/flicker in
Compliant plies buildings for residential purposes.
accordance with IEC 61000-3-3

10 Technical data
Guidelines and manufacturer's declaration - electromagnetic interference immunity

The Lighting System has been designed for operation in an environment as described below. The customer and the user of the
device should ensure that it is operated in such an environment. The Lighting System must not be able to perform any accidental
motions caused by interference. Important EMC performance characteristics of the Lighting System:
Interference immunity test IEC 60601-1 test level Conformity level Evironm./guidelines
Floors should be made from
wood or concrete or covered
Electrostatic discharge (ESC)
±6 kV contact discharge ±6 kV contact discharge with ceramic tiles. For floors
in accordance with
±8 kV air discharge ±8 kV air discharge consisting of synthetic mate-
IEC 61000-4-2
rial, the relative humidity must
be at least 30 %.
The quality of the supply vol-
Fast transient electrical distur- ±2 kV for power lines ±2 kV for power lines tage should correspond to the
bances/bursts in accordance ±1 kV for input and output ±1 kV for input and output quality required in a typical
with IEC 61000-4-4 lines lines business or hospital environ-
ment.
tage should correspond to the
Surge voltages in accordance ±1 kV normal mode voltage ±1 kV normal mode voltage
quality required in a typical
with IEC 61000-4-5 ±2 kV common mode voltage ±2 kV common mode voltage
business or hospital environ-
ment.
tage should correspond to the
100 % UN drop, 1 period 100 % UN drop, 1 period
quality required in a typical
60 % UN drop 5 periods 60 % UN drop 5 periods
business or hospital environ-
30 % UN drop 25 periods 30 % UN drop 25 periods
Voltage dips, short-time inter- ment.
100 % UN drop, 250 periods 100 % UN drop, 250 periods
ruptions and supply voltage If the continuous operation of
fluctuations in accordance the Lighting System must be
Note: Note:
with IEC 61000-4-11 ensured in case of a power fai-
UN designates the AC supply UN designates the AC vol-
lure, we recommend the use
voltage before applying the tage before applying the test
of an uninterruptible power
test levels. levels.
supply (UPS) or accumulator
battery.
Magnetic field at supply fre- Magnetic fields at mains fre-
quency (50/60 Hz) in quency should correspond to
3 A/m 3 A/m
accordance with the typical values in a busi-
IEC 61000-4-8 ness or hospital environment.

10 Technical data
Guidelines and manufacturer's declaration - electromagnetic interference immunity / portable and mobile radio equipment
Portable and mobile radio equipment should not be used closer to the Lighting System, including the corresponding cables, than
the recommended protective distance which is calculated on the basis of the equation to be applied for the transmission frequency.
Recommended protective distance:
Interference immunity test IEC 60601-1 test level Conformity level Environm./guidelines
Conducted HF disturbances in
accordance with 3 Veff 150 kHz to 80 MHz 3 Veff D = 1, 2 P
IEC 61000-4-6
D = 1, 2 P with:
Conducted HF disturbances in
80 MHz to 800 MHz *
accordance with 3 V/m 80 MHz to 2.5 GHz 3 V/m
D = 2, 3 P with:
IEC 61000-4-3
800 MHz to 2.5 GHz *
* P corresponds to the rated power of the transmitter in Watt (W) in accordance with the specifications of the transmitter manufac-
turer; D is the recommended protective distance in meters (m). For all frequencies, the field strength of stationary radio transmitters
should be less than the conformity level determined during an on-site inspection a.
b In the area of devices with the following graphic symbol, disturbances are possible:
Declaration on a and b:
a The field strength of stationary transmitters, e.g. base stations for radio and mobile phones, radio devices, amateur radio stations,
AM and FM radio and TV transmitters, cannot be exactly determined in advance. In order to determine the electromagnetic envi-
ronment with regard to stationary transmitters, a site study should be considered. If the field strength measured at a site where the
above-mentioned equipment is used exceeds the conformity levels, the Lighting System should be placed under observation. Addi-
tional measures may be required, e.g. with regard to the unit's alignment or position.
b Over a frequency range from 150 kHz to 80 MHz, the field strength should be less than 3 V/m.
Notes:
At 80 MHz and 800 MHz, the higher value applies.
These guidelines cannot be applied in all cases. Electromagnetic values are influenced by absorption and reflection from buildings,
objects and people.

10 Technical data
Controlled HF disturbances
The Lighting System has been designed for operation in an electromagnetic environment in which HF disturbances are controlled
accordingly. In this way, the customer or user of the above-mentioned device can help to prevent electromagnetic disturbances by
observing the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the above-men-
tioned device - depending on the output rating of the communication device as specified below.
Protective distance in accordance with the transmission frequency

Rated output, transm./W
Ambient conditions/guidelines
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
D = 1, 2 P D = 1, 2 P D = 2, 3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters whose maximum rated power is not indicated in the table above, the recommended protective distance D in meters
(m) can be determined from the equation assigned to the corresponding column; P corresponds to the maximum rated power of
the transmitter in Watt (W) in accordance with the specifications of the transmitter manufacturer.
Notes:
At 80 MHz and 800 Hz, the higher frequency range applies.
These guidelines cannot be applied in all cases. Electromagnetic values are influenced by absorption and reflection from buildings,
objects and persons.

1524523_06_01 US Operating Instructions AmbientLine | 01.02.2015

D-07318 Saalfeld
Telefon: +49 / 36 71 / 586 - 0
Telefax: +49 / 36 71 / 586 - 41 105
E-Mail: med@trumpf.com
www.trumpf-med.com

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Operating Instructions

AmbientLine Lighting System

TRUMPF Medizin Systeme GmbH + Co. KG

Which devices are covered by this user manual

1524523_06_01 US Operating Instructions AmbientLine | 01.02.2015 3

Customer Service is at your disposal

Manufacturer and distributor

Sales Phone:+49 / (0)89 / 8 09 07 - 0

Customer Service Phone:0 180 / 2 25 41 35

Customer Service Phone: +49 / 36 71/ 586 - 0

Visit us on the Internet www.trumpf-med.com

1524523_06_01 US Operating Instructions AmbientLine | 01.02.2015 4

Copyright and industrial rights

Modifications / amendments and translations

1524523_06_01 US Operating Instructions AmbientLine | 01.02.2015 5

1 Important information for safe use ................................................................................ 8

1524523_06_01 US Operating Instructions AmbientLine | 01.02.2015 6

6 Cleaning and Disinfection .......................................................................................... 28

8 Inspection, maintenance and repairs .......................................................................... 34

1524523_06_01 US Operating Instructions AmbientLine | 01.02.2015 7

1.1 How to identify the devices

Device identification – Device designation: Lighting System

1.2 How to identify the operating instructions

Operating Instructions identification – Edition: 1524523_06_01 US

1.3 Identification of target groups

These operating instructions refer to the following groups.

1.3.3 Qualified staff

1524523_06_01 US Operating Instructions AmbientLine | 01.02.2015 8

1.4 Information for operators

1.4.2 Availability of the operating instructions

1.4.4 Maintenance and repair

1.4.5 Service life of the device

1524523_06_01 US Operating Instructions AmbientLine | 01.02.2015 9

DIN EN ISO 13485 standard to all of its corporate processes.

1.5.1 Damage in transit

1.5.2 Address for returns

1.6 Notes for users

1.6.1 Hands-on training

1524523_06_01 US Operating Instructions AmbientLine | 01.02.2015 10

1.7 Intended purpose of the device

CE conformity mark: This item of equipment is a Class I medical device as defined by

1.7.2 Standards and directives

1.7.3 Proper use

1.7.4 Incorrect use

1524523_06_01 US Operating Instructions AmbientLine | 01.02.2015 11

• In the environment of the device, mixtures of inflammable anesthetic vapors with

1.7.5 Special features for use of the AmbientLine Lighting System

1.8 Ambient conditions for operation and storage

1.8.1 Ambient conditions for operation

1.8.2 Ambient conditions for storage

1.9 Use in combination with other medical devices

1524523_06_01 US Operating Instructions AmbientLine | 01.02.2015 12

2.1 Structure of the safety information in these

In these operating instructions, important safety information is indicated by symbols

2.1.1 Identification of risks of injury

2.1.2 Identification of risk of property damage

2.1.3 Identification of additional information

1524523_06_01 US Operating Instructions AmbientLine | 01.02.2015 13

2.2 Supplementary symbols used in the safety instructions

2.3 Symbols on the device

Observe the Instrucciones de uso: refers to these Instrucciones de uso.

1524523_06_01 US Operating Instructions AmbientLine | 01.02.2015 14

2.4 Overview of the most important safety information

When in contact with oxygen in the air, medical