PowerLED User Manual Edition 2D June 2014

User Manual

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USER MANUAL - EN

PowerLED

Copyright All rights reserved. This document may not be copied, adapted or translated without prior written permission, except as permitted under copyright law. © Copyright MAQUET SAS 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. 30th June 2014 | Ed.2D

PowerLED | User manual | EN | 0158102 | 2D |

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CONTENTS

4 4 4 5 7 8 9 11 11 12 12 13 13 14 14 15 15 17 19 21 21 22 24 25 26 27 28 28 29 30 34 34 34 37 37 38 38 39 39 43

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QUALITY STANDARDS COMPLIANCE CERTIFICATION OF MAQUET SAS’S QUALITY SYSTEM LNE/G-MED certifies that the quality system developed by MAQUET SAS for design, implementation, sales, installation and after-sales service of surgical lights complies with the requirements of the following international standards: ISO 9001:2008 EN ISO 13485:2012.

CE MARKING Compliance with the requirements of European Directive 93/42/EEC of 14 June 1993 relating to medical devices has been assessed in accordance with Annex VII of the Directive. PowerLED surgical lights belong to Class I as described in Annex IX of the Directive.

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WARNINGS !

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

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 light source 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 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 Class 1M LED product. Do not view directly with optical instruments when opened.

WARNING Dismantling certain elements may affect operation and safety. For example: When servicing the electrical power supply. When servicing the suspension arm and balance system. Contact the authorised MAQUET after-sales service department for this type of inspection.

WARNING To avoid any risk of an electric shock, class I electrical devices must only be connected to an earthed power supply system.

WARNING Do not touch the patient and non-sterile parts of the system at the same time.

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SYMBOLS USED IN THESE INSTRUCTIONS Symbols

Meaning Mandatory May affect patient or user safety

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.

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SYMBOLS USED ON THE PRODUCT Symbols

Meaning Attention Follow the instructions for use Read the documents supplied with unit carefully

Manufacturer

Alternating current Direct current

REF. SN.

Technical designation and serial numbers Comply with the applicable handling precautions for products that are sensitive to electrostatic discharges. 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 This equipment must not be disposed of with household waste as it is subject to separate collection for value enhancement, reuse or recycling.

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INTRODUCTION

1.1

INTENDED USE he PowerLED range is designed for use in medical applications to illuminate patients' T bodies during operations, diagnosis or treatment. The PowerLED 300 may be used as a surgical light when fitted with a sterilisable handle. The PowerLED range consists of the following versions: • mobile units (PWD 500 and 300) • wall-mounted unit (PWD 300) • ceiling-mounted units: single-arm, dual-arm or triple-arm units with single or double forks and equipped with LED lighting. Some models are prewired for video and/or feature MAQUET's AIM (Automatic Illumination Management) system.

1.2

SPECIAL FEATURES Excellent shadow dilution ompatibile with laminar flows C LED technology for exceptional light distribution LEDs for ambient light LED service life of 60,000 hours Upgraded multimedia AIM system (Automatic Illumination Management) for the PowerLED 700 FSP (Flux Stability Program) system: electronic illumination control.

1.3

INAPPROPRIATE USE 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 SAS‘s approval.

1.4

INTENDED USERS This device may only be used by trained medical staff. The device must be cleaned by specialised personnel.

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.

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1.6

ENVIRONMENTAL REQUIREMENTS TRANSPORT AND STORAGE Ambient temperature: -10°C to 60°C Relative humidity: 20-75% Atmospheric pressure: 500-1060 hPa. OPERATION Ambient temperature: 10°C to 40°C Relative humidity: 20-75% Atmospheric pressure: 700-1060 hPa The PowerLED system must be installed and commissioned in accordance with the EMC information provided on page 36. Portable and mobile RF communication devices may affect the correct operation of this equipment.

1.7

MAINTENANCE MAQUET SAS’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 SAS Parc de Limère Avenue de la Pomme-de-Pin CS 10008 ARDON 45074 ORLÉANS CEDEX 2 FRANCE Phone number: +33 (0) 2 38 25 88 88 Fax: +33 (0) 2 38 25 88 00 www.maquet.com

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DESCRIPTION

2.1

EXAMPLE: PWD 75 DF CONFIGURATION

4 6

7 5

7 8

Figure 1

1 2 3 4 5 6 7 8 9

Main arm Spring arm Double fork Ambient light Sterilisable handle Side positioning handle Underside Keypad Main light/ambient light and standard mode/AIM (Automatic Illumination Management) mode switchover button 10 On/Off button 11 Light intensity adjustment button (less) 12 Light intensity adjustment button (more)

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2.2

EXAMPLE: PWD 53 SF S CONFIGURATION

2.3

EXAMPLE: PWD 30 SF WALL-MOUNTED CONFIGURATION

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2.4

LIGHTHEAD TYPES MAIN LIGHTING for performing surgical procedures under the best conditions.

AMBIENT LIGHTING soft light for comfortable viewing of and around surgical sites.

PowerLED 700

PowerLED 500

PowerLED 300

2.5

VERSIONS AVAILABLE PowerLED 700

PowerLED 500

PowerLED 300

Surgical light with ambient light sterilisable handle Boost mode

Surgical light with ambient light Boost mode

optional video prewiring

optional sterilisable handle

optional AIM system

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2.6

OPTIONS Video prewiring (PowerLED 700 - 500) Allows the following to be installed:

A lighthead equipped with a PRV-CFF fixed-focus video camera (version 4).

A lighthead fitted with a MAQUET SAS zoom-lens video camera.

Denoted on the label by: - ‘V’ for pre-wired SD (standard definition) lighthead - ‘HD’ for pre-wired HD (high definition) lighthead

AIM system (Automatic Illumination Management) for the PowerLED 700 Automatically compensates the loss in illumination caused by heads between the lighthead and the operating field. The light from the hidden LEDs is dimmed whereas the light from the other LEDs is brightened to: - ensure stable illumination of the operating field, - provide the surgeon with unhindered movement, - improve working conditions for the surgeon.

Denoted by "AIM" on the label. R

2.7

OPTION XO The range POWERLED is compatible with the MAVIG lead shield (PN: MAQUET ARD567701907).

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USE

3.1

KEYPAD A keypad is available on: the fork, the WPS unit (optional), a wall-mounted keypad (optional).

PowerLED 700 - 500 - 300, standard mode

On/Off button

Status LED

Off

Unit off

Green

Unit on

Orange

Backup power supply on

Flashing red

Backup power supply on, backup battery nearly discharged

Red

Fault detected

Illumination adjustment

To change levels, press once or press and hold 10 illumination levels (2 by LED)

Battery charge indicator

The LEDs scroll

Boost mode

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

To activate boost mode, press and hold the “ ” button until the upper LED blinks. To desactivate Boost mode, press the other button.

WARNING The Boost mode is not stored in its memory for safety reason when the lighthead is switched off. When switched on, lighthead lights up gradually to the standard maximum intensity value. PowerLED | User manual | EN | 0158102 | 2D |

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PowerLED 700 - 500 - 300, ambient light On/Off button

Ambient light switchover button

Press once to turn on the lighthead.

Changes over with a short press of the button. Five illumination levels (adjustable with and buttons) LED off Switchover from ambient light to main light: gradual increase

Switchover from main light to ambient light: immediate dimming

PowerLED 700, AIM system On/Off button

Press once to turn on the lighthead.

Switchover to AIM mode

Turns on when button pressed and held until blue LED lights up Blue LED: AIM system on The AIM system cannot be turned on with the ambient light on

Illumination adjustment

To change levels, press once or press and hold. 5 illumination levels. Regardless of the level selected, the light output from the masked LEDs is dimmed while the light output from the other LEDs is brightened. However, the difference remains hardly noticeable to the naked eye. The only exception is the minimum level, where the masked LEDs are turned off.

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

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3.2

VIDEO CAMERA The lighthead prewired for video HD can be used with: the ORCHIS camera or the Prismavision PRV-ZOOM camera or the Prismavision PRV-CFF camera (versions 4 and higher) or the HD ORCHIDE camera. On the other hand, the standard video pre-cabled lighthead allows the integration only cameras ORCHIS, Prismavision PRV-ZOOM or Prismavision PRV-CFF (from the version 4). For information on the camera’s features, refer to the operator’s manual for each camera concerned. EXAMPLES OF VIDEO CONFIGURATION

SF configuration

DF configuration PowerLED | User manual | EN | 0158102 | 2D |

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USE

The camera turns on when the lighthead is switched on.

Handle for PRV-CFF camera

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

Handle for ORCHIS, Prismavision PRV-ZOOM and ORCHIDE 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.

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3.3 !

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

The power supplies may be optionally equipped for use with your operating room's 24 V backup power supply. The amount of runtime depends on the number of batteries installed. The operation of the light is not affected when the backup power supply switches on. When power is restored following a power failure, the light turns back on in the mode it was in. When the light is off and connected to backup batteries, the LEDs will scroll to indicate that the batteries are charging. BACKUP POWER SUPPLY STATUS LEDS LED colour

Comment

Orange

Backup power supply on following a mains power cut.

Flashing red

The batteries are nearly completely discharged. The light may turn off within a matter of minutes.

Red

Fault detected.

BATTERY BACKUP TEST (DAILY CHECK)

green LED

urn on the lighthead. T Press and hold the On/Off button for 5 seconds.

orange LED

he backup batteries take over. T The LED turns from green to orange. The lighthead automatically switches back to the mains supply 10 seconds later.

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CHECKING THE RUNTIME OF THE BATTERIES (MONTHLY CHECK)

To check Press the On/Off button on each lighthead.

Cut the mains supply with the light on.

LED colour

Comment

The LED turns green.

The LED turns orange.

The LED turns red and flashes.

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The lighthead is on.

The lighthead remains on. he batteries are now T powering the system. The batteries are nearly completely discharged. The light may turn off within a matter of minutes.

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MAQUET

Surgical Lights

PowerLED User Manual Edition 2D June 2014