TruLight 1000 Examination Light system Operating Instructions April 2012

Thank you very much

for purchasing the new TruLight 1000 lighting system. Please read these Operating Instructions very carefully, abide by the safety notices and observe all operating and cleaning requirements.

Device versions

For which devices do these Operating Instructions apply TruLight 1000 lighting system: • Version with light head as ceiling-mounted version • Version with light head as wall-mounted version • Version with light head as mobile pedestal version

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How to contact us

Customer Service is at your disposal • if you have questions about the device and its installation, • to reorder spare parts, • in service or warranty cases. Manufacturer and marketer 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

Aftersales service Inquiries from Germany

Aftersales service Inquiries from abroad E-mail

Visit us on the Internet

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: +49 / (0) 36 71 / 586 - 41 175 Phone: +49 / 36 71/ 5 86 - 0 Fax: +49 / (0) 36 71 / 586 - 41 175 [email protected] www.trumpf.com www.trumpf-med.com

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Notes relating to this documentation

Copyright

Modifications to the device Modifications to the Operating Instructions

Translations

Copyright and property rights All rights reserved. These Operating Instructions are protected by copyright law. • Any other use than those regulated by law must be approved in writing by TRUMPF Medizin Systeme GmbH + Co. KG, hereinafter referred to as TRUMPF. • TRUMPF does not take any liability for or in relation to the misuse of this information in the prohibited manner by any person or company. Modifications and translations Since our products are subject to continuous further development, we reserve the right to modify the form, equipment and technology of our scope of supply. • The contents of these Operating Instructions are subject to change without prior notice. • Make sure you keep informed of the current version of these Operating Instructions at regular intervals, e.g. via the TRUMPF Online Information System (OIS). • In case of translations into foreign languages, the German version of these Operating Instructions shall take precedence. Trademarks TruLight 1000® is a registered trademark of TRUMPF. • All trademarks mentioned in these Operating Instructions are the sole and exclusive property of the corresponding manufacturer.

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Table of contents

1

Important information for safe use ... 8 1.1 Information for identification of the device ...8 1.2 Operating Instructions identification ...8 1.3 Identification of target groups ...8 1.3.1 Operator ...8 1.3.2 User...8 1.3.3 Qualified staff ...8 1.4 Notes for the operator ...9 1.4.1 Initial commissioning ...9 1.4.2 Availability of these 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 the user...10 1.6.1 Instruction on the device ...10 1.6.2 User's duty to inform and inspect ...10 1.7 Intended purpose of the device ...11 1.7.1 Marking ...11 1.7.2 Standards and guidelines...11 1.7.3 Normal use...11 1.7.4 Special conditions ...11 1.7.5 Incorrect use ...12 1.7.6 Contraindications ...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 Disposal...12

2

Safety Instructions... 13 2.1 Structure of the safety information in these Operating Instructions...13 2.1.1 Warnings of risk of injury ...13 2.1.2 Warnings of damage to property ...13 2.1.3 Indication of additional information...13 2.2 Supplementary symbols used in the safety instructions...13 2.3 Symbols on the device ...14 2.4 Overview of the most important safety instructions ...15

3

Technology of the Lighting System ... 18 3.1 3.2

4

The light head...18 LED technology ...18

Identification of the Lighting System ... 19 4.1 Use of serial numbers and rating plates ...19 4.1.1 Identifications on the ceiling-mounted version ...19 4.1.2 Identifications on the wall-mounted version ...19 4.1.3 Identifications on the mobile pedestal version ...20

5

Descriptions of device and functions ... 21 5.1 5.2 5.3

Device description of the ceiling-mounted version ...21 Functional description of the pendant system ceiling-mounted version ... 22 Device description of the wall-mounted version ...23

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Table of contents

5.4 5.5 5.6

6

Functional description of the pendant system - wall-mounted version ...24 Device description of the mobile pedestal version ...25 Functional description of the pendant system mobile pedestal version ... 26

Start-up ... 27 6.1 Checking the lighting system...27 6.1.1 Risk of trapping fingers when positioning the lighting system ... 28 6.1.2 Collision hazard during positioning ...28 6.1.3 Positioning the ceiling- / wall-mounted version ...29 6.1.4 Power supply of the wall-mounted version with cable connection ...30 6.1.5 Positioning the mobile pedestal version ...31 6.1.6 Power supply of the mobile pedestal version ...32

7

Operation ... 33 7.1 7.2 7.3 7.4 7.5 7.6 7.7

8

Cleaning, disinfection and sterilization ... 37 8.1 8.2

9

Rules to be obeyed when working on the device ...33 Preparatory measures ...33 Points to be taken into consideration when using the lighting system ...34 Placing / removing the sterilizable hand grip ...35 Positioning the light head ...35 Switching the light head on / off ...36 Adjusting the illumination level ...36

Cleaning and disinfection ...37 Sterilizing the hand grip...38

Inspection, maintenance and repair ... 39 9.1 9.2 9.3 9.4

Inspections during operation ...39 Annual visual inspection ...39 Biannual maintenance...40 Repair...40

10 Adjustments ... 42 10.1 10.2

Adjusting the spring tension of the spring arm ...42 Adjusting the brake force of the horizontal bracket ...43

11 Wearing parts... 44 12 Troubleshooting ... 45 13 Technical Data ... 46 13.1 13.2

Device data ...46 EMC information...47

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1 Important information for safe use

1.1

Information for identification of the device

These Operating Instructions are intended solely for devices with the manufacturer's rating plate bearing the following information: – Device designation: – Type designation: – Device with serial number (or higher):

Device identification

1.2 Make sure you are usingthe latest version Identification of these Operating Instructions

TruLight 1000 ceiling , wall, mobile pendant 100833439

Operating Instructions identification

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: 1695233_01_03 US – Version: April 15, 2012 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

The following groups of persons are mentioned in these Operating Instructions: 1.3.1 Operator Any natural person or legal entity who owns the device or regulates its use or in whose behalf the device is used is referred to as the "operator" (medical practice, hospital, etc.). • The operator shall be liable for handing over a safe device and for instructing the user in its proper operation and normal use. 1.3.2 User Users a persons who, due to their professional qualification or proper instruction by qualified personnel, are authorized to operate the device and work with it. • Users shall be fully responsible for the safe operation of the device in accordance with its intended purpose. 1.3.3 Qualified staff Any authorized person, usually employees of the operator, and: • persons who underwent special professional training in the field of medical engineering, • persons who can assess their work and recognize the potential hazards involved on the basis of their professional experience and instruction in safety-relevant regulations. • In States where job activities in the medical engineering sector are subject to certification, qualified personnel must have obtained the corresponding certificate.

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1 Important information for safe use

1.4 Procedural guidelines

Validity

Duty to inform

Warranty

Notes for the operator

Although the device has been designed according to the state of the art and is safe to operate, it must be considered a potential source of danger, in particular when operated by insufficiently trained personnel or used improperly and not as prescribed. • The device may only be operated, cleaned, disinfected and maintained by qualified personnel. 1.4.1 Initial commissioning 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 lighting system in accordance with the applicable Operating Instructions. • The lighting system 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 these Operating Instructions Since these Operating Instructions are an integral part of the device, they must always be kept near the device in order to be able to look up safety instructions and important information on use at any time. • Do not pass on the device to any third party without valid Operating Instructions. Based on the ID and version numbers, make sure that you hand over an up-to-date and valid version of the Operating Instructions together with the device. 1.4.3 Warranty TRUMPF guarantees the safety and functional reliability of the device only on condition that: • The device is used exclusively as prescribed and operated, maintained and repaired as stipulated in this instruction manual; • Only spare parts and accessories authorized by TRUMPF are used; • No structural alterations are made on the device; • Inspections and maintenance are carried out at the specified time intervals; • initial commissioning has been carried out and the device has been released for operation by means of a declaration of acceptance. 1.4.4 Maintenance and repair Maintenance and repair work on this device or on parts thereof must be carried out by: – TRUMPF aftersales service, – authorized service companies trained by TRUMPF, – service personnel of the operator which 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 functionality, provided that the product is used in accordance with the specifications in the Operating Instructions, the provision of service and also spare parts supply. • TRUMPF subjects all of its corporate processes to a quality management system certified in accordance with DIN EN ISO 13485.

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1 Important information for safe use

• 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.

Damage claims

Accompanying documents

Returns

1.5.1 Damage in transit Damage claims can only be considered if TRUMPF is notified immediately. In case of damage in transit or shortages, a damage report including the following information must be forwarded to TRUMPF: • Damage report providing information on the damages or defects • Main serial number of the device/system or serial numbers of the damaged components • 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 To return an item, use the original packaging if possible. Returns must be sent to the following address: TRUMPF Medizin Systeme GmbH + Co. KG Carl-Zeiss-Straße 7-9 D-07318 Saalfeld Germany

1.6

Notes for the user

Only properly instructed persons may operate this device.

Instruction

Troubleshooting

1.6.1 Instruction on the device The instruction by qualified personnel of the operator or by the manufacturer's authorized installer must be carried out immediately on the device. • On completion of the instruction, a certificate must be created and signed in order to document that the user has understood the special operator control actions required for normal use. 1.6.2 User's duty to inform and inspect Read these Operating Instructions carefully prior to initial use of the device. This ensures that you benefit from all the advantages of the device and prevents any risk of injury or damage to property. • Prior to any use or transfer for use, the functional reliability and proper condition of the device must be inspected by the user.

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1 Important information for safe use

• In case of special problems which are not sufficiently described in detail in these Operating Instructions, contact your supplier for your own safety.

1.7 Conformity

Intended purpose of the device

1.7.1 Marking The manufacturer declares that this product complies with the basic requirements of MDD Appendix I and shows conformity by means of the CE and UL mark. CE marking: This device is a Class I medical device in accordance with the European Medical Device Directive (MDD).

UL mark

UL mark: device tested by Underwriter Laboratories Inc. for use in the USA and Canada with respect to electric shock, fire and mechanical hazards.

1.7.2 Standards and guidelines The device complies with the safety requirements of the following standards and directives: • MDD 93/42/EEC, 2007 - Medical Device 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 60601-2-41:2009 (IEC 60601-2-41: 2009) - Particular Requirements for the Basic Safety and Essential Performance of Surgical Luminaires and Luminaires for Diagnosis; UL/cUL classification: • UL 60601-1, 1st Edition, 2006-04-26 • CAN/CSA C22.2 No. 601.1 - M 90, 2005

Normal use

Working range

High illumination level Superposition of the luminous fields

1.7.3 Normal use Lighting unit for the local illumination of the PATIENT'S BODY to support diagnoses or treatments which may be interrupted in case of light failure without HAZARD to the PATIENT. • The working range is at a distance between 70 and 150 cm from the examination area. • The device is suitable for continuous operation. • Any use beyond the conditions specified above shall be considered as incorrect use (misuse). The user or operator shall be exclusively liable for any damage arising from incorrect use. 1.7.4 Special conditions To ensure good visual conditions, the light head provides high illumination levels. • According to the laws of physics, visible light also produces heat in the examination area. In case of reduced blood circulation or any symptoms of tissue dehydration, the illumination level must be reduced.

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1 Important information for safe use

Examinations in the field of vision

Incorrect use

Restriction

• In case of examinations in the field of vision with unprotected, open eyes, high local illumination levels can cause damage to 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 in accordance with Protection Level 6 EN169). 1.7.5 Incorrect use The EXAMINATION LIGHT is not suitable for use in ORs. • The light suspension unit must not be exposed to additional loads. • The device must not be exposed to strong vibration. • The device is not suitable for operation in explosive areas. • The device is not suitable for use in rooms with inflammable mixtures of anesthetics with air or oxygen or N20 (nitrous oxide). If such high concentrations of inflammable mixtures of anesthetics with oxygen or nitrous oxide occur in the environment of the device, 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. 1.7.6 Contraindications No contraindications have been found.

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 %; • Atmospheric pressure: 700 hPa to 1060 hPa. 1.8.2 Ambient conditions for storage • Ambient temperature: -15 °C to 60 °C; • Relative humidity: 5 % to 95 %; • Atmospheric pressure: 500 hPa to 1060 hPa.

1.9

RoHS conformity

Disposal

The device must be disposed of at a suitable collection point for the recycling of electrical and electronic devices in accordance with country-specific regulations. • The device complies with the requirements of the 2002/95/EC RoHS Directive (on the restricted 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

Important notes in these Operating Instructions are marked with graphic symbols and signal words. 2.1.1 Warnings of risk of injury Signal words such as DANGER, WARNING or CAUTION describe the degree of risk of injury. The different triangle symbols visually emphasize the degree of hazard.

1 DANGER

DANGER refers to an immediate hazard, which, if not avoided, will lead to death or severe injury.

1 WARNING

WARNING refers to a potentially dangerous situation which, if not avoided, can lead to death or severe injury.

1 CAUTION

CAUTION refers to a potential hazard, which, if not avoided, can lead to minor or slight injury. 2.1.2

NOTICE

NOTICE refers to a potential hazard, which, if not avoided, can lead to damage to property. 2.1.3

NOTE

Warnings of damage to property

Indication of additional information

A NOTE provides additional information and useful tips for the safe and efficient use of the device.

2.2

Supplementary symbols used in the safety instructions

Gas explosion: warns of the ignition of explosive mixtures of gases.

Electric shock: warns of electric shock which can lead to severe injury or even death.

Sudden release of spring arm: Risk of spring arm suddenly jumping up when dismantling the light head/flat screen.

Lighting system crashing: warns of the risk of the lighting system suddenly crashing because additional loads have been attached.

Protection of the patient's eyes: warns of damage to the patient's eyesight during examinations or operations in the field of vision.

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2 Safety Instructions

Damage to surfaces: warns of damage to surfaces caused by improper cleaning agents and disinfectants.

2.3

Symbols on the device

CE conformity marking: shows conformity with the guidelines of the European Medical Device Directive (MDD).

Read the Operating Instructions: refers to this document.

UL mark: device tested by Underwriter Laboratories Inc. for use in the USA and Canada. UL/cUL classification with respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1, 2006 and CAN/CSA C22.2 No. 601.1 - M 90, 2005.

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2 Safety Instructions

2.4

Overview of the most important safety instructions

Site requirements

1 DANGER Gas explosion The lighting system is not suitable for use in environments containing inflammable mixtures of anesthetics with high concentrations of oxygen or nitrous oxide. If such high concentrations of inflammable mixtures of anesthetics with oxygen or nitrous oxide occur in the environment of the device, 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.

Examinations in the field of vision

1 WARNING Damage to eyesight During examinations in the patient's field of vision, high illumination levels of the light head can cause damage to eyesight: • Protect the patient's eyes e.g. using safety goggles. • Do not look directly into the light beam.

Strong luminous fields

1 WARNING Risk of tissue damage to the patient High illumination levels can cause tissue damage. The light head's illumination level must be reduced in case of any symptoms of tissue dehydration.

Electrostatic charge compensation

1 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.

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2 Safety Instructions

Additional loads

1 WARNING Lighting system crashing Do not attach any additional loads to the lighting system.

Illumination level of the light head

1 CAUTION Failure of LEDs Following failure of the third LED, the light head no longer delivers the specified illumination level. • Take the lighting system out of operation. • Contact TRUMPF aftersales service. The light head on the lighting system may only be replaced or repaired by TRUMPF aftersales service or service personnel duly trained and authorized by TRUMPF.

Uncontrolled swivel motion

1 WARNING Risk of injury due to uncontrolled swivel motion If the spring tension of the spring arm has not been correctly adjusted, there is a risk of injury due to uncontrolled swivel motions of the spring arm. Risk of trapping fingers When swiveling the light head the distance between the horizontal bracket and the light head changes: • While swiveling the light head do not place your fingers between the horizontal bracket and the light head. • Hold the light head only by the sterilisable hand grip.

Cleaning and disinfection

1 WARNING Risk of contamination and infection for patients through improper cleaning of the cover plate The use of unapproved disinfectants can result in damage to or even destruction of the light head cover plate. Detached 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.

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2 Safety Instructions

• 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. Recommended cleaning agents: • Meliseptol (manufacturer: B.Braun Melsungen AG, D-34209 Melsungen, 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. Risk of contamination and infection of the patient If cleaning agent/disinfectant is allowed to penetrate the device, excess 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. • Refrain from any other disinfection method than wiping disinfection. Damage to surfaces/paint work To prevent damage: •Only use products without chlorides or halogenides. • Do not use any petrol, paint thinners, alkaline, acidic or aldehyde containing cleaning agents. • Do not use any abrasives.

Commissioning

1 CAUTION Initial commissioning prior to use Prior to use for medical operation, the lighting system must be subjected to initial commissioning, including all relevant tests, before being handed over to the operator. • Initial commissioning comprises the functional test and safety inspection of the complete lighting system. • Handover must be documented by means of a declaration of acceptance.

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3 Technology of the Lighting System

3.1 Operation

Illumination level

The light head

The light head is ergonomically adjusted via the unsterile control panel on the light head. The illumination level can be adjusted in a range from 50 % to 100 %. A reduction (dimming) of the illumination level does not change the color temperature of the light.

3.2

LED technology

The lighting system is equipped with a future-oriented illuminant: the LED (Light Emitting Diode). Period of operation

Contrary to conventional halogen or discharge lamps, LEDs stand out due to their particularly long service life.

Low heat development

The low heat development due to the absence of IR radiation (infra-red) and tissue damaging UV radiation (Ultra-Violet) is a further benefit of the LED.

High failure safety

Due to the use of large number of LEDs, the light head has a high degree of failure safety. The failure of individual LEDs does not impair the functioning of the light head.

Homogeneous

The LEDs incorporated in the light head ensure a homogeneous color temperature in the 4.500 Kelvin area.

color temperature

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4 Identification of the Lighting System

Figure 1

4.1

Use of serial numbers and rating plates

A lighting system is identified through its rating plate and serial numbers. • The rating plate 1 includes the specific device data and the main serial number. The main serial number represents the order-specific identification of an entire device. The main serial number also serves for the identification of components without separate serial numbers and thus enables the delivery of suitable spare parts by TRUMPF aftersales service. • The serial numbers 2 identify the individual components of a device. 4.1.1

Identifications on the ceilingmounted version A Ceiling-mounted version • Rating plate 1 with the main serial number on the ceiling tube. • The serial numbers 2 of the individual components can be found on the: – light head – horizontal bracket – ceiling tube – extension arm with spring arm. 4.1.2

Identifications on the wall-mounted version B Wall-mounted version • Rating plate 1 with the main serial number on the wall bearing cover. • The serial numbers 2 of the individual components can be found on the: – light head – horizontal bracket – extension arm with spring arm.

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4 Identification of the Lighting System

Figure 2

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4.1.3

Identifications on the mobile pedestal version C Mobile pedestal version • Rating plate 1 with the main serial number on the wall bearing cover. • The serial numbers 2 of the individual components can be found on the: – light head – horizontal bracket – extension arm with spring arm – pedestal foot.

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5 Descriptions of device and functions

Figure 3

5.1

Device description of the ceiling-mounted version

Components of the ceiling-mounted version The ceiling-mounted version is designed as a: • single-arm pendant system with a light head 3 on the horizontal bracket 5 . • The pendant system consists of : – the canopy 1 , – the central column 2 with the horizontally rotatable extension arm 6 , – the horizontally and vertically adjustable spring arm 4 . Power supply The ceiling mount fixture and the power supply components of the lighting system are located underneath the canopy 1 . Light head control panel Control panel A for switching the light head on / off and for controlling the illumination level, equipped with: – Button 7 for switching the light head on / off, – button 8 for reducing the illumination level, – button 9 for increasing the illumination level. The illumination level can be adjusted in three steps: – 50 % – 75 % – 100 % Hand grip Sterilizable hand grip B for the sterile positioning of the light head.

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