TruLight 5000 and 3000 lighting system Operating Instructions March 2011

Thank you very much for purchasing the new TruLight lighting system. Please read through these operating instructions carefully and ensure adherence to all safety instructions and requirements regarding the operation and care of the device. Which devices are covered by these operating instructions

TruLight lighting system: • Available as a single luminaire with a light head as a pedestal, wall-mounted or ceiling version. • Available as a surgical lighting system with a combination of 2 to 3 light heads as a ceiling version. • Optional equipment also available such as the light head with camera. The TruLight 5000 light heads have the following versions

Both large light heads and small light heads are available for the TruLight 5000 light series. For more detailed information on the corresponding variants, refer to the Technical Data Chapter. The TruLight 3000 light heads have the following versions

Both large light heads and small light heads are available for the TruLight 3000 light series. For more detailed information on the corresponding variants, refer to the Technical Data Chapter. You will find all the information required to operate the optional camera system in the following operating instructions: • TruVidia SD camera system and VidiaPort TFT pendant system, • TruVidia HD camera system and VidiaPort TFT pendant system.

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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 order spare parts, • for servicing or warranty claims. Manufacturer and distributor

TRUMPF Medizin Systeme GmbH + Co. KG Carl-Zeiss-Strasse 7-9 D-07318 Saalfeld Germany How to contact us

TRUMPF Medizin Systeme GmbH + Co. KG Benzstrasse 26 D-82178 Puchheim Germany Sales

Customer Service Inquiries from Germany

Phone:+49 / (0)89 / 8 09 07 - 0 Fax:+49 / (0)89 / 8 09 07 - 40 222 Phone:0 180 / 2 25 41 35 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 Inquiries from abroad E-Mail Visit us on the Internet

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Phone: +49 / 36 71/ 586 - 0 Fax: +49 / 36 71 / 586 - 41 175 [email protected] www.trumpf.com www.trumpf-med.com

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Notes relating to this documentation

Copyright

Copyright and property rights • All rights reserved. These operating instructions are protected

by copyright.

Modifications to the device

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Any use other than that permitted by law must be approved in writing by TRUMPF Medizin Systeme GmbH + Co. KG, hereinafter referred to as "TRUMPF".

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TRUMPF shall assume no liability whatsoever arising from or connected in any way to the prohibited use of this information by any person or entity.

Modifications and translations • 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 and technology. Amendments to the operating

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instructions

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Translations

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The contents of these operating instructions are subject to amendment at any time without notice. Please keep up to date on the current version of the operating instructions, e.g. using the TRUMPF Online Information System (OIS) at regular intervals. The German-language version of these operating instructions shall be binding as regards translations into foreign languages.

Trademarks • TruLight 5000® and TruLight 3000® are registered trademarks •

of TRUMPF. All other trademarks mentioned in these operating instructions are the sole property of the relevant manufacturer.

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Contents 1

Important information for safe use...9 1.1 How to identify the device ...9 1.2 How to identify the operating instructions ...9 1.3 Identification of target groups...9 1.3.1 Operators ...9 1.3.2 Users ...9 1.3.3 Qualified staff...10 1.4 Information for operators ...10 1.4.1 Commissioning...10 1.4.2 Availability of the operating instructions...10 1.4.3 Warranty ...10 1.4.4 Maintenance and repair ...11 1.4.5 Service life of the device ...11 1.5 Notes for users...11 1.5.1 Hands-on training ...11 1.5.2 Duty of the user to keep himself informed and inspect the device...11 1.6 Intended purpose of the device...12 1.6.1 Marking ...12 1.6.2 Standards and directives ...12 1.6.3 Proper use...13 1.6.4 Special characteristics...13 1.6.5 Improper use ...14 1.6.6 Contraindication ...14 1.7 Ambient conditions for operation and storage ...14 1.7.1 Ambient conditions for operation...14 1.7.2 Ambient conditions for storage ...14 1.8 Combination with other medical devices ...14 1.9 Disposal...15

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Safety instructions ...16 2.1 Structure of the safety information in these operating instructions...16 2.1.1 Indication of risks of injury ...16 2.1.2 Indication of risk of property damage...16 2.1.3 Indication of additional information ...16 2.2 Supplementary symbols used in the safety instructions...16 2.3 Symbols on the device ...17 2.4 Overview of the most important safety information ...18

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Technology of the lighting system ...22 3.1 3.2

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Identification of the lighting system ...24 4.1 4.2 4.3 4.4

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The light head ...22 LED technology...23

Use of serial numbers ...24 Position of serial numbers on the ceiling version ...24 Position of serial numbers on the wall version ...24 Position of serial numbers on the mobile pedestal version ...24

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Contents 5

Descriptions of device and functions ... 26 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10

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Device description of the ceiling version... 26 Automatic control of the light intensity on the ceiling-mounted version... 28 Device description of the ceiling version with camera ... 30 Functional description of the ceiling versions ... 32 Device description of the wall version ... 34 Automatic control of the light intensity on the wall-mounted version. ... 36 Functional description of the wall version ... 38 Device description of the mobile pedestal version ... 40 Automatic control of the light intensity on the mobile pedestal version ... 42 Functional description of the mobile pedestal version... 44

Start-up ... 46 6.1 Checking the lighting systems ... 46 6.1.1 Risk of trapping fingers when positioning the lighting systems... 48 6.1.2 Risk of collisions when positioning... 48 6.2 Positioning a surgical lighting system ... 50 6.3 Positioning of the mobile pedestal versions ... 52 6.3.1 Connecting the mobile pedestal version to the mains... 54 6.3.2 Disconnecting the mobile pedestal version from the mains ... 56

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Operation ... 58 7.1 Rules when working ... 58 7.2 Preparations... 58 7.3 Mounting the sterile hand grip ... 60 7.4 Switching on the light head... 62 7.5 Positioning the light head ... 62 7.6 Setting the illuminance ... 62 7.6.1 Setting the illuminance on the control panel... 62 7.6.2 Adjusting the light intensity on the sterile hand grip with Sterile Light Control ... 63 7.7 Adjusting the light intensity to the selected working distance... 64 7.7.1 Adjusting the light intensity with Adaptive Light Control... 64 7.7.2 Adjusting the light intensity with Adaptive Light Control Plus... 64 7.7.3 Camera system with Adaptive Light Control Plus... 65 7.8 Switching off the light head... 66 7.9 Disconnecting the lighting system ... 66

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Cleaning, disinfection and sterilization ... 68 8.1 8.2 8.3

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Switch off the power supply... 68 Cleaning and disinfection... 69 Sterilizing the hand grips ... 70

Inspection, maintenance and repairs ... 72 9.1 9.2 9.3 9.4

Inspections by the operator... 72 Annual visual inspection ... 72 Biennial maintenance... 73 Repairs ... 74

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Contents 10 Adjustments ...75 10.1 Adjusting the swiveling range of the AC 2000 LCH spring arm ...75 10.1.1 Disconnecting the lighting system ...75 10.1.2 Removing the cover panels ...75 10.1.3 Adjust the swiveling range...75 10.1.4 Mounting the cover panels...75 10.2 Adjusting the swiveling range on the spring arms, type AC2000 and type AC 3000 ...76 10.2.1 Disconnecting the lighting system ...76 10.2.2 Adjust the swiveling range...76 10.3 Adjusting the swiveling range on the AC 5000 spring arm...77 10.3.1 Disconnecting the lighting system ...77 10.3.2 Removing the cover panels ...77 10.3.3 Adjust the swiveling range...77 10.3.4 Mounting the cover panels...77 10.4 Adjusting the spring force of the AC 2000 LCH spring arm ...78 10.5 Adjusting the spring force on the spring arms, type AC2000, type AC 3000 ...79 10.6 Adjusting the spring force on the AC 5000 spring arm ...80 10.7 Adjusting the brake force of the AC 2000 LCH spring arm...81 10.7.1 Disconnecting the lighting system ...81 10.7.2 Removing the cover panels ...81 10.7.3 Mounting the cover panels...82 10.8 Adjusting the brake force of the AC 3000 spring arm...83 10.9 Adjusting the brake force on the pendant system of the ceiling and wall version...84 10.10 Adjusting the brake force for the light head without camera ...85 10.10.1 Disconnecting the lighting system ...85 10.10.2 Dismantling the components ...85 10.10.3 Adjusting the brake force ...85 10.10.4 Mounting the components ...86 10.11 Adjusting the brake force for the light head with ALC+ and SLC...87 10.11.1 Disconnecting the lighting system ...87 10.11.2 Dismantling the components ...87 10.11.3 Adjusting the braking screw...87 10.11.4 Mounting the components ...88 10.12 Adjusting the brake force for the light head with camera...89 10.12.1 Disconnecting the lighting system ...89 10.12.2 Dismantling the components ...89 10.12.3 Adjusting the brake force ...89 10.12.4 Mounting the components ...89 11 Wearing parts ...90 12 Troubleshooting ...91 13 Technical data ...93 13.1 Electromagnetic Compatibility (EMC) ...97

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1 Important information for safe use 1.1 •

These operating instructions are intended solely for devices with the nameplate bearing the following information: – Device designation: TruLight 5000/3000 lighting system – Type designation: TruLight 3000 – Devices upwards of serial number:100789741 – Type designation: TruLight 5000 – Devices upwards of serial number:100789740

Device identification

1.2 Make sure you have the latest version

How to identify the device

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How to identify the operating instructions

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: – Edition: – As on:

Operating Instructions identification

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1528404_06_01 US 01.03.2011

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 obligated 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 qualified 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.

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1 Important information for safe use 1.3.3 Qualified staff Qualified staff are authorized 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 recognize 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 license, the classification as qualified staff is subject to the appropriate licensing.

1.4 Procedural guidelines

Validity

Duty to supply information

Warranty

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Information for operators

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 • These operating instructions are only valid after the device has been properly commissioned by the operator or an installation engineer authorized by the manufacturer. • Prior to its first use, the device must be thoroughly cleaned and disinfected. • Once the device has been released for operation, the instructions in these operating instructions are binding for the user. 1.4.2 Availability of the operating instructions 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 valid 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 TRUMPF 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 these operating instructions, • only original spare parts and accessories specifically authorized by TRUMPF are used, 1528404_06_01 US TruLight Operating Instructions

1 Important information for safe use • • •

no structural modifications are made to the device, inspections and servicing are carried out at the specified intervals, the device is correctly commissioned and released for operation with a commissioning declaration.

1.4.4 Maintenance and repair Maintenance and repair work on this appliance or on parts thereof must be carried out by: – the TRUMPF customer service, – authorized service companies trained by TRUMPF, – operator service personnel which has been trained and authorized by TRUMPF.

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1.4.5 Service life of the device Provided that all applicable safety and maintenance instructions are strictly adhered to, TRUMPF 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 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

Notes for users

Please note that the device may only be used by personnel who have been trained to use it.

Training

Troubleshooting

1.5.1 Hands-on training • All training must be hands-on at the device and carried out by qualified staff of the operator or by the installation engineer authorized by the manufacturer. • On completion of the training, it must be documented that the user has understood the special operating measures required for correct use of the device for its intended purpose. 1.5.2 Duty of the user to keep himself informed and inspect the device • Please ensure you have thoroughly read these operating instructions before using the device for the first time. This allows you to maximize all the advantages offered by the device and helps prevent injuries and damage to the device.

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1 Important information for safe use 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 operating instructions, please contact your supplier for your own safety. •

1.6 Conformity

Intended purpose of the device

1.6.1 Marking 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.

UL mark

The UL mark confirms that the device has been tested by Underwriter Laboratories Inc. for use in the USA and Canada with regard to risk of electric shock, fire hazard and mechanical hazard..

1.6.2 Standards and directives The device complies with the safety requirements of the following standards and directives: • MDD 93/42/EWG, 2007 - Medical Product Directive; • EN 60601-1-2:2007 (IEC 60601-1-2: 2007) - Medical Electrical Equipment - Electromagnetic Compatibility; • EMC Directive; 2004/108/EC – Electromagnetic compatibility (of electrical and electronic equipment); • EN 60601-1:2006 (IEC 60601-1: 2005) - General Requirements for Basic Safety and Ergonomic Design; • EN 60601-2-41:2001 (IEC 60601-2-41: 2009) - Particular Requirements for the Safety of Surgical Luminaires and Luminaires for Diagnosis; • IEC 60825-1: 2007 - Safety of Laser Products. UL/cUL classification: • UL 60601-1, 1st Edition, 2006-04-26 • CAN/CSA C22.2 No. 601.1 - M 90, 2005 Combined use with other medical devices: • IEC 60601-1 • IEC 60601-1-1 • UL 60601-1

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1 Important information for safe use

Proper use

Working range

Definition: Small surgical luminaire

1.6.3 Proper use • The device is intended to locally illuminate an operating or examination area of the patient’s body with high intensity light in a clinic or doctor´s place. • It operates at a distance of 70 - 150 cm from the intervention site. • The device is suitable for continuous operation. • Any use other than that described above shall be deemed improper use. The user/operator shall be solely liable for any damage or loss incurred as a result of such improper use. Single luminaire • A single luminaire as defined in IEC 60601-2-41 is a small

surgical luminaire and may only be used for operations where any light failure would not pose a risk to the patient.

Definition: Surgical lighting system

Surgical lighting system • A surgical lighting system with multiple light heads can be used

without restrictions.

High illuminance Overlapping luminous fields

Operations in the facial area

1.6.4 Special characteristics The high illuminance of the light heads ensures that surgeons have good visibility. • Due to its physical characteristics, visible light also creates heat in the surgical field. Overlapping luminous fields of multiple light heads produce high irradiance, which could cause tissue dehydration and, particularly given extended exposure and reduced circulation, tissue damage. If a patient starts to suffer poor circulation or tissue dehydration, the level of illuminance must be reduced immediately. • In the case of surgery in the patient's field of vision with unprotected, open eyes, high local light intensities from OR lamps or direct eye contact with laser radiation can damage eyesight. The patient's eyes must be closed or protected if required (e.g. using safety goggles with an optical density of at least 2, or meet the requirements of degree of protection 6 in accordance with EN169 standard). • The laser used for distance measuring on the ALC function is classified as a Class 2 Laser with the following values: – maximum power 0.95 mW, – wavelength 620-690 nm, – beam divergence 0.16 x 0.6 mRad, – pulse duration 0.4 x 10 ^ -9 s, – pulse repetition rate 320 MHz. •

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1 Important information for safe use

Improper use

Restrictions

1.6.5 Improper use • The luminaire suspension must not be subjected to additional loads. • The device is not designed to withstand strong vibrations. • The device is not suitable for operation in potentially explosive atmospheres. • The device is not suitable for use in rooms or atmospheres in which combustible mixtures of anesthetics and air, oxygen or N2O (laughing gas) are used. If high concentrations of inflammable mixtures of anesthetics with oxygen or nitrous oxide occur in the environment of the appliance, there is a risk of ignition under certain conditions. In accordance with EN 11197, the hazardous zone includes an area of between 5 cm and 25 cm from the gas leak or exit point. 1.6.6 Contraindication • No contraindications have been found.

1.7

Ambient conditions for operation and storage

Different conditions are required for the operation and interim storage of the device. 1.7.1 Ambient conditions for operation • Ambient temperature: 10°C to 40°C; • Relative humidity: 30% to 75%; • Air pressure: 700 hPa to 1060 hPa. 1.7.2 Ambient conditions for storage • Ambient temperature: -15°C to 60°C; • Relative humidity: 5% to 95%; • Air pressure: 500 hPa to 1060 hPa.

1.8 Read the operating instructions for combined medical products

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Combination with other medical devices

The system can be equipped with further medical devices from other manufacturers. For the operation of these devices, please refer to the respective operating instructions. • Only medical devices approved in accordance with IEC 60601-1 or UL 60601-1 may be attached to the system. If a medical device is installed afterwards, the installation must be performed as specified in IEC 60601-1 and IEC 60601-1-1 or in accordance with the specifications provided by the manufacturer. Compliance with this standard must be ensured by the service technician responsible. •

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1 Important information for safe use 1.9 •

RoHS conformity

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Disposal

The device should be disposed of in accordance with the pertinent national regulations at a suitable waste disposal point for the recycling of electrical and electronic equipment. The device meets the requirements of Directive 2002/95/EC RoHS (restriction of the use of certain hazardous substances in electrical and electronic equipment).

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2 Safety instructions 2.1

Structure of the safety information in these operating instructions

2.1.1 Indication of risks of injury In these operating instructions, important safety information is indicated by symbols and signal words. Signal words such as DANGER, WARNING or CAUTION identify the severity of the risk of injury. The different triangle symbols visually emphasize the degree of danger.

1 DANGER

DANGER indicates an immediate hazard, which, if not avoided, will cause death or serious injury.

1 WARNING

WARNING indicates a potential hazard, which, if not avoided, may cause death or serious injury.

1 CAUTION

CAUTION indicates a potential hazard, which, if not avoided, may cause minor or slight injury. 2.1.2 Indication of risk of property damage

NOTICE

NOTICE indicates a potential hazard, which, if not avoided, may cause damage to property. 2.1.3 Indication 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.

Sudden release of spring arm: warns of the risk of sudden release of the spring arm if the light head/flat-screen monitor is dismantled. Lighting system dropping: warns of the risk of the lighting system suddenly dropping if subjected to additional loads

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2 Safety instructions

Eye protection for patients: warns of the risk of damage to the eyesight of patients during operations in the facial area.

Eye damage from laser radiation: warns of the patient's and medical personnel's eyesight being damaged by laser radiation. Risk of trapping fingers: warns of the risk of trapping fingers in the device.

Damage to surfaces: warns of the risk of damage to the surfaces through the use of unsuitable cleaning agents or disinfectants.

2.3

Symbols on the device

CE conformity mark: confirms conformity of the device to the guidelines of the European Medical Device Directive (MDD).

Refer to operating instructions: advises users/operators to refer to these operating instructions. UL mark:confirms that the 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 only in accordance with UL 60601-1, 2006 and CAN/ CSA C22.2 no. 601.1 – M 90, 2005. Laser marking: Warns of the emission of a laser beam. Indicates the class and specifications of the laser installed.

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2 Safety instructions 2.4

Overview of the most important safety information

Location requirements

1 DANGER Gas explosion

The lighting system is not suitable for operation in potentially explosive atmospheres. The lighting system is not suitable for use in rooms or atmospheres in which combustible mixtures of anaesthetics and air, oxygen or N2O (laughing gas) are used. Additional loads

1 WARNING Falling lighting system

Do not place any additional loads on the lighting system. Operations in the facial area

1 WARNING Risk of damage to eyesight

If the light heads are set to high illuminance levels during operations to the facial area of patients, there is a risk of damage to patients' eyesight: • Always ensure that the eyes of the patient are protected (e.g., using safety goggles). • Do not look directly into the luminaire’s light orifice. Overlapping of the luminous fields of multiple light heads

1 WARNING Risk of tissue damage to patients

Overlapping the luminous fields of multiple light heads with high illuminance can cause damage to tissue. If the tissue begins to dehydrate: • separate overlapping luminous fields of multiple light heads, • reduce the illuminance of the light heads.

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2 Safety instructions Contact with laser beams

1 WARNING Damage to eyesight

Direct eye contact with the laser beam can damage eyesight: • Do not look directly into the laser beam. • Protect the patient's eyes: The patient's eyes must be closed or protected if required (e.g. using safety goggles with an optical density of at least 2, or meet the requirements of degree of protection 6 in accordance with EN169 standard). • Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. Risk of trapping fingers

1 CAUTION Risk of trapping fingers

When swiveling the light head, the distance between the central bar and the two light heads is reduced: • When swiveling the light head, do not place your fingers between the central bar and the two light heads. • Only position the light heads from the sterile hand grip or the non-sterile hand grips (outer hand grips). Cleaning and disinfection

1 WARNING Failure to clean the cover plate correctly presents a risk of contamination and infection for the patient

Using unauthorized disinfectants may damage or even destroy the cover plate. Parts of the cover plate can fall into open wounds: • Use of the disinfectant Terralin is not permitted. • Do not use disinfectants that contain benzalkonium chloride, 2-phenoxylethanol, aminoalkylglycerine. • Only use disinfectants approved by the manufacturer for use on the following materials: Polycarbonate (PC), polyamide (PA), polyvenyl chloride (PVC), acrylonitrile-butadiene-styrene

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2 Safety instructions copolymere (ABS), Polyetherimide (PEI) and on silicones. We recommend the cleaning agent: • Meliseptol (manufacturer: B. Braun Melsungen AG, 34209 Melsungen, Germany, phone: +49 5661 710) • Bacillol 25 ((manufacturer: BODE Chemie GmbH, Melanchthonstraße 27, D-22525 Hamburg, phone +49 (0) 40 / 5 40 06-0 • or commercially available 70% isopropyl alcohol. Cleaning and disinfection

1 WARNING Risk of contamination and infection of patients

If cleaning agent or disinfectant is allowed to penetrate the device, surplus cleaning agent / disinfectant may drip into open wounds: • Use cleaning agents / disinfectants sparingly so that no liquid enters the device. • The cloth used to clean / disinfect the device should only be damp, not wet. • Only use the wipe-down disinfection method to disinfect the device. Cleaning and disinfection

NOTICE Damage to surfaces / lacquered surfaces

To avoid damage: • Only use agents that do not contain chlorides or halides. • Do not use benzine, paint thinner, alkaline / acidic agents or aldehyde-based cleaning agents. • Do not use abrasive cleaners. Adjustments

1 CAUTION Carrying out adjustments

The manufacturer only guarantees the safety and problem-free function of the device on the provision that all adjustments are performed by an authorized hospital technician or person with comparable qualifications.

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2 Safety instructions Dismantling during servicing

1 WARNING Sudden release of spring arm

If the light head/flat-screen monitor is dismantled, it is essential to first ensure that the spring arm is placed in its uppermost limit position as the spring arm could suddenly bounce upwards and cause serious injuries. • For this reason, the light head/flat-screen monitor may only be dismantled by a member of the TRUMPF Customer Service. Commissioning

1 CAUTION Initial start-up prior to operation

Before using the lighting system during medical operation, an initial start-up must be carried out and the lighting system must be handed over to the operator following inspection. • The initial start-up includes functional and safety tests of the entire lighting system. • Acceptance shall be documented by means of a declaration of acceptance.

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