HELION lighting system Operating Instructions April 2011

Thank you very much for purchasing the new HELION 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. The following versions are covered by this user manual HELION lighting system ceiling versions • Small operating lamp (single lamp) with HELION L or M lamp • • •

as a ceiling version; Examination lamp (single lamp) with HELION S lamp as a ceiling version; Operating lighting system with a combination of 2 to 3 HELION L, M or S lamps as a ceiling version; and optional equipment.

HELION lighting system wall versions • Small operating lamp (single lamp) with HELION L or M lamp •

as a wall version; Examination lamp (single lamp) with HELION S lamp as a wall version.

HELION lighting system mobile pedestal versions • Small operating lamp (single lamp) with HELION L or M lamp •

as a mobile pedestal version; Examination lamp (single lamp) with HELION S lamp as a mobile pedestal version.

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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 re-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

1441785_04_01 EN HELION lighting system Operating Instructions

Notes relating to these operating instructions

Copyright

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

by copyright.

Modifications to the device

•

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".

•

TRUMPF shall assume no liability whatsoever on the basis of, or in association with, the prohibited use of information by any person or company.

Modifications / amendments 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 or technology. Amendments to the

•

The contents of these operating instructions are subject to amendment at any time without notice. Please obtain information on the current version of the operating instructions at regular intervals, e.g. via the TRUMPF Online Information System (OIS).

•

The German language version of these operating instructions shall be binding with regard to translations into foreign languages.

operating instructions

Translations

Trademarks • HELION® is a registered trademark of TRUMPF. • All other trademarks mentioned in these operating instructions

are the sole property of the relevant manufacturers.

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Table of contents

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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...9 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...12 1.5.1 Hands-on training ...12 1.5.2 User’s duty to keep himself informed and inspect the device ...12 1.6 Intended purpose ...12 1.6.1 Identification...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 Contraindications...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...14

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Safety instructions ...16 2.1 Structure of the safety information in these operating instructions...16 2.1.1 Identification of risks of injury ...16 2.1.2 Identification of risk of damage to property...16 2.1.3 Identification 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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Description of device and functions ...22 3.1 Description of HELION ceiling version devices ...22 3.2 Description of the HELION ceiling version devices with camera ...24 3.3 Description of functioning of HELION ceiling version devices ...26 3.4 Description of HELION wall version devices...28 3.5 Description of functioning of HELION wall version devices...30 3.6 Description of HELION pedestal version devices ...32 3.7 Description of functioning of HELION pedestal version devices ...34

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Commissioning ...36 4.1 Checking the HELION lighting system ...36 4.2 Inserting a focus unit or optional camera into the HELION L or M lamp ...38 4.3 Inserting a focus unit into the HELION S lamp ...40

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Table of contents 4.4 Positioning the HELION lighting system... 42 4.4.1 Positioning an operating lighting system suspended from the ceiling... 42 4.4.2 Positioning of the pedestal versions ... 42 5

Operating ... 44 5.1 Operating the HELION L and M lamp ... 44 5.1.1 Switching the lamp on... 44 5.1.2 Positioning the lamp and attaching the sterile handle... 44 5.1.3 Adjusting the light ... 44 5.1.4 Switching the lamp off... 44 5.1.5 Disconnecting the lamp... 44 5.2 Operating the HELION S lamp ... 46 5.2.1 Switching the lamp on... 46 5.2.2 Positioning the lamp and attaching the sterile handle... 46 5.2.3 Switching the lamp off... 46 5.2.4 Disconnecting the lamp... 46 5.3 Operating the optional camera, eco ... 48 5.3.1 Functions ... 48 5.3.2 Positioning the lamp and attaching the sterile handle... 48 5.3.3 Switching the camera, eco and flat-screen monitor on ... 48 5.3.4 Focusing the image ... 48 5.3.5 Switching the lamp and camera off ... 48 5.3.6 Disconnecting the lamp and camera ... 48 5.4 Operating the optional camera, pro... 50 5.4.1 Functions ... 50 5.4.2 Positioning the lamp and attaching the sterile handle... 50 5.4.3 Switching the camera, pro and flat-screen monitor on... 50 5.4.4 Creating a still image... 50 5.5 Performing the white balance... 52 5.5.1 Zooming the image (zoom in/zoom out)... 52 5.5.2 Focusing the image ... 52 5.5.3 Changing the image brightness ... 52 5.6 Switching the lamp and camera off ... 54 5.6.1 Disconnecting the lamp and camera ... 54 5.7 Changing the HELION L and M lamp bulbs ... 56 5.7.1 Protection against failure ... 56 5.7.2 Disconnecting the lighting system ... 56 5.7.3 Removing the focus unit or camera ... 56 5.7.4 Changing faulty bulbs ... 58 5.7.5 Performing the functional test... 58 5.8 Changing the HELION S lamp bulb ... 60 5.8.1 Disconnecting the lighting system ... 60 5.8.2 Removing the focus unit ... 60 5.8.3 Changing faulty bulbs ... 60 5.8.4 Performing the functional test... 60

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Cleaning, disinfection and sterilisation ... 62 6.1 Switching off the power supply ... 62 6.2 Cleaning and disinfection... 63 6.3 Sterilizing the hand grips ... 64

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Table of contents 7

Inspections, maintenance and repairs ...66 7.1 Inspections by the operator ...66 7.2 Annual visual inspection ...66 7.3 Biennial maintenance ...67 7.4 Repairs...68

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Adjustments ...69 8.1 Adjusting the spring force on the spring arms AC 2, AC 3 and AC 2 LCH ...69 8.2 Adjusting the swivelling range on the spring arms type AC 2 and type AC 3 ...69 8.3 Adjusting the braking force on the spring arm AC Swing...70 8.4 Adjusting the braking force on the spring arm AC 2 LCH ...70 8.5 Adjusting the braking force on the spring arm AC 3 ...70 8.6 Adjusting the braking force on the pendant system ...71

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Troubleshooting ...72

10 Technical data ...74 10.1 Electromagnetic Compatibility (EMC) information ...76

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1 Important information for safe use 1.1 •

These operating instructions are intended solely for devices with the manufacturer's rating plate bearing the following information: – Device designation: Lighting system – Model designation: HELION – Devices from serial no. onwards: 100000012963

Device identification

1.2 Make sure you

How to identify the device

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have the latest version

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 a 2-digit version number and country code. – Edition: – Date:

Operating instructions - identification

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1441785_04_01 EN 2011_04_01

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' practices, 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 appropriate training by qualified staff, are entitled to operate and work with the device. • Users are entirely 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 authorized persons who are generally employees of the operator and: • have acquired their skills through professional training in the medical sector, 1441785_04_01 EN HELION lighting system Operating Instructions

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1 Important information for safe use 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 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 device may still constitute a hazard, particularly if it is used by staff without sufficient training or if it is 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 on 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 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, • 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 commissioning declaration. 1441785_04_01 EN HELION lighting system Operating Instructions

1 Important information for safe use 1.4.4 Maintenance and repair • Maintenance and repair work on this device or on parts thereof must be carried out by: – TRUMPF Customer Service, – authorized service companies trained by TRUMPF, – operator service personnel that has been trained and authorized by TRUMPF. 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. •

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1 Important information for safe 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 operator qualified staff or by the installation engineer authorized by the manufacturer. • On completion of training, it must be documented in an instruction report that the user has understood the special operating measures required for proper use of the device for its intended purpose. 1.5.2 User’s duty to keep himself informed and inspect the device • Maker sure that 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. • 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

1.6.1 Identification 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. 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; (Medical Device Directive MDD 93/42/EWG, 2007, Appendix IX); • 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 Lumi-

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1 Important information for safe use naires for Diagnosis; Combined use with other medical devices: • IEC 60601-1 • IEC 60601-1-1

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 practice. • 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 illumination Overlapping luminous fields

Operations in the facial area

1.6.4 Special characteristics The high illumination of the light heads ensures that surgeons have good visibility when carrying out difficult visual tasks. • Due to its physical characteristics, visible light also creates heat in a surgical environment. Overlapping luminous fields of multiple light heads create high irradiance, which could cause tissue dehydration and – in particular in the event of prolonged 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 which meet the requirements of degree of protection 6 in accordance with the EN169 standard). • The laser used for measuring distance using 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 vibration. • The device is not suitable for operation in potentially explosive atmospheres. • The device is not suitable for use in rooms or environments with atmospheres containing combustible mixtures of anaesthetics with air, oxygen or N2O (laughing gas). 1.6.6 Contraindications • 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 1,060 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 1,060 hPa.

• • •

1.8 Read the operating instructions for combined medical products

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 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. •

1.9 •

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Combination with other medical devices

Disposal

The device should be disposed of in accordance with the corresponding national regulations and at a suitable waste disposal point for the recycling of electrical and electronic devices. 1441785_04_01 EN HELION lighting system Operating Instructions

1 Important information for safe use RoHS conformity

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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 Identification 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 emphasise the degree of danger.

1 DANGER

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

1WARNING

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

1CAUTION

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

NOTICE

NOTICE indicates a potential hazard, which, if not avoided, may 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.

Sudden release of spring arm: warns of the risk of sudden release of the spring arm if the light head/flat screen is dismantled. Lighting system falling: warns of the risk of the lighting system suddenly falling 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. Hot surface warns of the possible risk of burns on hot bulbs or heated lamp components.

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 with the guidelines of the European Medical Device Directive (MDD). Refer to operating instructions: advises users / operators to refer to these operating instructions. Hot surface warns of the possible risk of burns on hot bulbs or heated lamp components.

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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 environments with atmospheres containing combustible mixtures of anaesthetics with air, oxygen or N2O (laughing gas). Additional loads

1WARNING Lighting system falling

Do not place additional loads on the lighting system.

Operations in the facial area

1WARNING Risk of damage to eyesight

If the light heads are set to high illumination levels during operations to the facial area of patients, there is a risk of damage to patients' eyes: • Always ensure that the eyes of the patient are protected by using protective eyewear.

Overlapping of the luminous fields of several light heads

1WARNING Risk of tissue damage to patients

Overlapping luminous fields of multiple light heads with high illuminance can cause tissue damage. 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 Cleaning and disinfection

1WARNING 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 Terralin disinfectant is not permitted. • Do not use disinfectants that contain benzalkonium chloride, 2-phenoxylethanol, amino-alkylglycerine. • Only use disinfectants approved by the manufacturer for use on the following materials: Polycarbonate (PC), polyamide (PA), polyvenyl chloride (PVC), acrylonitrile-butadiene-styrene 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.

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 a wipe-down disinfectant to disinfect the device.

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2 Safety instructions 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.

Changing the bulb

1WARNING Electric shock hazard

Touching live parts in the lamp can result in an electric shock hazard. Before changing the bulb: • Isolate the lighting system at the power switch in the operating theatre or pull out the power plug; • Take precautions to prevent the power switch or power plug from being turned on / plugged in again unintentionally.

1 CAUTION Hot surface

Bulbs heat up when in operation and give off heat to the lamp. There is a risk of a burn involved if the hot halogen lamp is touched. Before changing the bulb: • Allow the lamp to cool down.

Adjustments

1CAUTION Carrying out adjustments

• The manufacturer only guarantees the safety

and trouble-free operating of the device on condition that all adjustments are performed by an authorized hospital technician or someone with comparable qualifications.

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2 Safety instructions Dismantling during servicing

1WARNING Sudden release of spring arm

If the light head/flat screen 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 may only be dismantled by a member of TRUMPF Customer Service.

Commissioning

1CAUTION 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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