X'TEN User Manual Feb 2011

Copyright All rights reserved. May not be duplicated, adapted or translated, in whole or in part, without prior written permission except where allowed by copyright law. © Copyright Maquet S.A. Subject to technical changes. The illustrations and technical specifications provided in this manual may, on account of future product developments, differ slightly from the actual product supplied. 16.02.2011 | Ed2K

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CONTENTS

Quality standards compliance Warnings Symbols used in this manual Symbols used on the product 1 Introduction 2 Description 2.1 Example of double configuration 2.2 Versions available 3 Use 3.1 Energix WPS power supply unit 3.2 Optional LCD 3.3 Optional control via a remote PC 3.4 Optional ambient light 3.5 Optional backup power supply 3.6 Optional video camera 4 Positioning the lighthead 4.1 Moving the lighthead 4.2 Pre-positioning examples by speciality 4.3 Degrees of rotation 4.4 Fitting the sterilisable handle 4.5 Fitting the single-use sterile handle 5 Cleaning/Disinfection/Sterilisation 5.1 Cleaning and disinfecting the surgical light 5.2 Cleaning and sterilising the handles 6 Maintenance 6.1 First level maintenance 6.2 Annual maintenance 7 Replacing the bulbs 8 Accessories 9 General characteristics 10 EMC declaration 11 Troubleshooting

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QUALITY STANDARDS COMPLIANCE CERTIFICATION OF MAQUET SA’S QUALITY SYSTEM LNE/G-MED certifies that the quality system developed by MAQUET SA for design, implementation, sales, installation and after-sales service of surgical lights complies with the requirements of the following international standards: ISO 9001:2000 ISO 13485:2004

CE MARKING Compliance with the requirements of European Directive 93/42/EEC dated 14 June 1993 relating to medical devices was assessed as described in Annex VII of the Directive. X’TEN surgical lights belong to Class I as described in Annex IX of Directive 93/42/EEC.

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WARNINGS !

WARNING Changes or modifications not expressly approved by MAQUET SA could void the user’s authority to operate the equipment.

!

WARNING Light is a form of energy that can dry out tissue, particularly if light beams from more than one lighthead are superimposed. Users must be vigilant and set appropriate illumination levels for each operation and patient, in particular for long operations.

!

WARNING Light is a form of energy that, on account of certain wavelengths emitted, may not be suitable for certain pathologies.

!

WARNING The surgical light is a high-intensity light source. Do not look directly into it.

!

WARNING Do not use the device in the presence of flammable anaesthetic gases.

!

WARNING Do not use in an MRI environment.

!

WARNING Check that the sterilisable/disposable handle is compatible with the product.

!

WARNING Before reusing the handle after it has been sterilised, always: Check for cracks. Check that the handle clicks into place correctly in the surgical light.

!

WARNING To avoid all risks of asepsis, never touch the control keypad on the fork during a surgical procedure unless it is protected by a single-use cover.

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!

WARNING To avoid all risk of asepsis, only the medical team may touch the sterilisable handle during procedures.

!

WARNING Do not store objects on the wall power supply units.

!

WARNING Solutions containing glutaraldehyde, phenol, iodine, bleach, alcohol or chloride ions must not be used. Fumigation methods are unsuitable for disinfecting the unit and must not be used.

!

WARNING In the event of a power cut, only lightheads connected to a backup power supply will remain on.

!

WARNING The unit is designed to operate with the cover closed. When conducting maintenance, take precautions to avoid touching surfaces marked as hot with the appropriate symbol.

!

WARNING The operation and safety of the device may be affected by the removal of certain components during servicing operations. For example: When servicing the electrical power supply. When servicing the suspension arms and balance system. Contact the authorised MAQUET after-sales service department for this type of inspection.

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SYMBOLS USED IN THIS MANUAL Symbols

Meaning Mandatory May affect patient or user safety

F

Recommendation Risk of damage to device or accessories CE label The device complies with the requirements of European directive 93/42/EEC relating to medical devices. Medical Equipment Classified with respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1, IEC 60601-2-41 and CSA C22.2 No. 601-M90.

SYMBOLS USED ON THE PRODUCT Symbols

Meaning Caution Read the documentation for the unit thoroughly. ~

Alternating current Direct current

REF. SN. 23.5VRMS (VRMSAC+DC)

Product technical description and serial numbers. Rectified true RMS voltage on bulb terminals Metal housing protection class Class 1B device Use black lamp holders only Hot surface Medical Equipment Classified with respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1, IEC 60601-2-41 and CSA C22.2 No. 601-M90. CE label The device complies with the requirements of European directive 93/42/EEC relating to medical devices. Do not dispose of this device as unsorted municipal waste. Take it to a collection facility for value enhancement, recycling or re-use.

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1

INTRODUCTION

1.1

INTENDED USE

1.2

SPECIAL FEATURES

 he X’TEN range is designed for use in medical applications to illuminate patients' bodies T during operations, diagnosis or treatment. The X’TEN range consists of single-arm, dual-arm or triple-arm ceiling-mounted lights with single or double forks. Some models are equipped with LED ambient lighting and are prewired for video.

Excellent shadow dilution  ide range of movement W Compatible with laminar flows Incredible volume of light LEDs for ambient light Upgraded multimedia

1.3

INAPPROPRIATE USE

1.4

INTENDED USERS

The unit is intended only for use as mentioned in the user manual and is suitable only for such use. Any other use may result in danger to users and/or damage to the device or its environment. For safety reasons, do not alter or adapt the device in any way without MAQUET SA's approval.

The device may be operated only by trained medical staff.  he device must be cleaned by specialised personnel. T

1.5

INTENDED EQUIPMENT The models named in this document may be equipped with other manufacturers’ end appliances (e.g. flat screens). For information on operating them, please refer to each manufacturer’s user manuals.

1.6

ENVIRONMENTAL REQUIREMENTS TRANSPORT AND STORAGE Ambient temperature: -10°C to 60°C Relative humidity: 20-75% Atmospheric pressure: 500 to 1060 hPa

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OPERATION Ambient temperature: 10°C to 40°C Relative humidity: 20-75% Atmospheric pressure: 700 to 1060 hPa The X’TEN system must be installed and commissioned in accordance with the EMC information provided in chapter 10. Portable and mobile RF communication devices may affect the correct operation of this equipment.

1.7

MAINTENANCE MAQUET SA's warranty and the safety and integrity of the operation of the product are guaranteed only if: All inspection, maintenance and repair operations are performed by a MAQUET engineer or a trained and authorised technical support technician. Only original accessories, consumables and spare parts are used. Maintenance operations and checks are performed and documented at least once a year as specified by the preventive maintenance programme.

1.8

USER MANUAL This user manual is an integral component of the equipment. It must be kept near the equipment for future reference. It must be read in full before attempting to use the equipment.

1.9

FCC PART 15 (USA only) This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference, in which case the user will be required to correct the interference at personal expense.

1.10

MANUFACTURED BY MAQUET SA Parc de Limère Avenue de la Pomme de Pin CS 10008 ARDON 45074 ORLÉANS CEDEX 2 FRANCE Telephone: +33 (0) 2 38 25 88 88 Fax: +33 (0) 2 38 25 88 00 www.maquet.com

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2

DESCRIPTION

2.1

EXAMPLE OF DOUBLE CONFIGURATION

1

11

2 5

12

4

3

13

6

9

7

10

8

Figure 1

1

Main arm

2

Spring arm

3

Double fork

4

Ambient light: ring of LEDs

5

Side positioning handle

6

Underside

7

Sterilisable handle

8

Shell

9

Cover

10 Lamp holder 11 Keypad 12 Surgical light button 13 Ambient light button

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2.2

VERSIONS AVAILABLE Standard version

Simple surgical light

LED Version

Surgical light

+ Ambient light

Video version

Surgical light

+ Ambient light

+ Video prewiring

MAIN LIGHTING for performing surgical procedures under the best conditions. AMBIENT LIGHTING for easy viewing of and around operating fields.

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3

USE

3.1

ENERGIX WPS POWER SUPPLY UNIT The light is turned on and off via the ENERGIX WPS power supply units.

On/Off button

Turns lighthead on and off with a single press. Lighthead lights up gradually to the last intensity value stored in its memory. Factory set to 100% illumination. Power supply off

LED off

Power supply on Green LED

Red LED

Illumination adjustment

Flashing yellow LED

!

 ackup power supply on B (WPS XX1 only)

To change levels, press once or press and hold. 8 illumination levels (2 per LED) Bulb failure or Ambient light

WARNING Do not store objects on the wall power supply units.

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3.2

OPTIONAL LCD The LCD is used to: Check the service life of consumables (bulbs, bulb holder, batteries), Perform routine tests (backup tests), Troubleshoot malfunctions.

3.3

OPTIONAL CONTROL VIA A REMOTE PC Light turned on via the ENERGIX unit

 ink not operational L Settings are adjusted via the ENERGIX unit

Light turned on via the PC

Operational link Settings are adjusted via the PC

! The link will be cut if adjustments are made via the ENERGIX unit.

3.4

OPTIONAL AMBIENT LIGHT Use the keypad on the lighthead fork to toggle between lighting modes.

Press the button once to switch off the surgical light and turn on the ambient light. To increase the illumination, press the button again (4 illumination levels: 50 lx, 90 lx, 140 lx, 210 lx ± 10%). Flashing yellow LED = ambient light on.

Press to switch off the ambient light and turn on the surgical light.

Note: Lighting differences may occur in low-intensity ambient lighting mode (LEDinside™).

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3.5 !

OPTIONAL BACKUP POWER SUPPLY WARNING In the event of a power cut, only lightheads connected to a backup power supply will remain on.

 he power supplies may be optionally equipped for use with your operating room's 24 V T backup power supply. If the mains supply is restored after being cut, the light turns on in surgical light mode.

Red LED

Backup power supply on (WPS XX1 only)

BATTERY BACKUP TEST (DAILY CHECK)  urn on the lighthead. T Press and hold the On/Off button for 3 seconds.  he backup batteries take over. T The LED turns from green to red. The lighthead automatically switches back to the mains supply 3 seconds later.

BATTERY CAPACITY TEST (MONTHLY CHECK)  ress and hold the «+», «-» buttons and the On/Off button for P 2 seconds.

The backup batteries take over.  llow the batteries to discharge (one hour per lighthead). A

BATTERY GOOD

Battery charge sufficient.

BATTERY BAD

Replace the batteries.

 ress the On/Off button to interrupt the test or to switch back to the P mains supply.

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3.6

OPTIONAL VIDEO CAMERA The lighthead prewired for video can be used with: a PRV-ZOOM camera or a PRV-CFF camera (versions 4 and higher). For information on the camera's features, refer to the Prismavision camera user manual. USE The camera turns on when the lighthead is switched on.

A sterilisable handle with viewing window is required to use the camera. PRV-CFF camera

PRV-ZOOM camera

The image on the screen rotates when the handle is turned. This allows the operator/observer to adjust the image so that it is positioned correctly.

Note: the light volume can no longer be adjusted if a camera is fitted on the lighthead. It is therefore recommended to adjust the volume before fitting a camera.

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4

POSITIONING

4.1

MOVING THE LIGHTHEAD The light should be positioned prior to any procedures to avoid having to move it more than necessary later on. Correctly positioning the light for each operation will limit the chances of it coming into contact with other objects (IV pole, pendant, etc.).

1 m

Use the removable handle at the centre or the handle on the side to position the lighthead.

F

Recommended distance between the underside and the operating field: 1 m.

RECOMMENDATION Do not direct the lighthead towards the ceiling while the light is on. Doing so could damage certain internal parts.

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LIGHTHEAD WITHOUT CAMERA Turn the handle to adjust the light volume to the needs of the procedure. The range of the adjustment is limited by stops.

LIGHTHEAD WITH CAMERA The image on the screen rotates when the handle is turned. This allows the operator/ observer to adjust the image so that it is positioned correctly.

!

WARNING To avoid all risk of asepsis, only the medical team may touch the sterilisable handle during procedures.

F

RECOMMENDATION Do not use the light suspension system to carry or raise objects. Do not hang from the light.

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4.2

PRE-POSITIONING EXAMPLES BY SPECIALITY Pre-positioning examples

Surgical specialities

General surgery

Figure 1

Urology, organ transplants, gynaecology, delivery

Figure 2

General surgery, abdominal surgery, digestive surgery, thoracic surgery

Figure 3

Proctology

Figure 4

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Pre-positioning examples

Surgical specialities

Neurosurgery

Figure 5

Plastic and reconstructive surgery, face transplants, oral and maxillofacial surgery

Figure 6

Otolaryngology, ophthalmology, dermatology

Figure 7

Note: The positions illustrated are given for guidance only. Each operator will choose the correct position of the light for his/her work habits.

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4.3

DEGREES OF ROTATION

360° 360°

45°

330° 310° 360°

50° 330°

290°

205°

Double fork version

290°

15° 360° 360°

360°

40°

Single fork version

290°

15° 270° 360°

Single fork video version

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360°

40°