Getinge MAQUET HLX 3000 User manual

HLX 3000
USER MANUAL - EN

HLX 3000 | User manual | EN | 0132102 | 2G |
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.
01.04.2010 | Ed2G

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CONTENTS
Quality standards compliance | 4
Warnings | 5
Symbols used in this manual | 6
Symbols used on the product | 6
1Introduction | 7
2Description | 9
2.1 Example of double configuration | 9
2.2 HLX 3000 product range | 10
3Use | 11
3.1 Energix WPS power supply unit | 11
3.2 Optional LCD | 12
3.3 Optional control via a remote PC | 12
3.4 Optional backup power supply | 13
4Positioning | 14
4.1 Moving the lighthead | 14
4.2 Pre-positioning examples by speciality | 15
4.3 Degrees of rotation | 17
4.4 Fitting the sterilisable handle | 18
5Cleaning/Disinfection/Sterilisation | 19
5.1 Cleaning and disinfecting the surgical light | 19
5.2 Cleaning and sterilising the handles | 20
6Maintenance | 22
6.1 First level maintenance |22
6.2 Annual maintenance |23
7Replacing the bulbs | 24
8Accessories | 25
9General characteristics | 26
10 EMC declaration | 27
11 Troubleshooting | 31

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REFERENCE STANDARDS
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 9001:2008
ISO 13485:2004
The HLX 3000 surgical light is designed to comply with the following standards:
EN 1041: 2008 Information supplied by the manufacturer with medical devices
EN ISO 14971:2000/A1:2003 Medical devices - Application of risk management to medical
devices
(ISO 14971:2000)
EN 60601-1:1990 Medical electrical equipment - Part 1: General requirements for safety
Amendment A1:1993 to EN 60601-1:1990
Amendment A2:1995 to EN 60601-1:1990
EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety
- Collateral standard: safety requirements for medical electrical systems
EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for safety
- Collateral standard: Electromagnetic compatibility - Requirements and
tests
EN 60601-1-4:1996 Medical electrical equipment - Part 1-4: General requirements for safety
- Collateral standard: Programmable electrical medical systems
Amendment A1:1999 to EN 60601-1-4:1996
EN 60601-1-6:2004 Medical electrical equipment - Part 1-6: General requirements for safety
- Collateral standard: Usability
EN 60601-2-41:2000 Medical electrical equipment - Part 2-41: Particular requirements for the
safety of surgical luminaires and luminaires for diagnosis
EN 980:2008 Graphical symbols for use in the labelling of medical devices
FCC part 15 Radiofrequency device
This product has been verified for compliance with the following additional standards:
CAN/CSA-C22.2 No. 601.1-M90 (R2005)
(includes national differences for Canada),
EN 60601-1:1990 + A1:1993 + A2:1995
UL 60601-1, first edition, 2006-04-26
(includes national differences for the USA)
This device does not meet FCC/UL requirements unless it is equipped with a MAQUET SA
electrical power supply.
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. HLX 3000 surgical
lights belong to Class I as described in Annex IX of Directive 93/42/EEC.
QUALITY STANDARDS COMPLIANCE
CERTIFICATION OF MAQUET SA’S QUALITY SYSTEM

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Changes or modifications not expressly approved by MAQUET SA could void the user’s
authority to operate the equipment.
WARNING
WARNINGS
!
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
!
Do not use in an MRI environment.
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
!
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.
WARNING
!
Do not use the device in the presence of flammable anaesthetic gases.
WARNING
!

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SYMBOLS USED IN THIS MANUAL
Symbols Meaning
Mandatory
May affect patient or user safety
FRecommendation
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. Product technical description and serial numbers.
22.8VEFF (VRMS
AC+DC)Rectified true RMS voltage on bulb terminals
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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INTRODUCTION1
INTENDED USE1.1
The HLX 3000 range is designed for use in medical applications to illuminate patients' bodies
during operations, diagnosis or treatment.
The HLX 3000 range consists of single-arm, dual-arm or triple-arm ceiling-mounted lights with
single or double forks. Some models are prewired for video (HANAUVISION). Possible options:
comfort bracket, flat screen holder, separate camera holder, dimmer.
SPECIAL FEATURES1.2
Excellent shadow dilution
Wide range of movement
Compatible with laminar flows
Upgraded multimedia
Excellent adaptation of the operating field to all types of surgery.
INAPPROPRIATE USE1.3
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.
INTENDED USERS1.4
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.
INTENDED EQUIPMENT1.5
Ambient temperature: -10°C to 60°C
Relative humidity: 20-75%
Atmospheric pressure: 500 to 1060 hPa
TRANSPORT AND STORAGE
The device may be operated only by trained medical staff.
The device must be cleaned by specialised personnel.
ENVIRONMENTAL REQUIREMENTS1.6

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Ambient temperature: 10°C to 40°C
Relative humidity: 20-75%
Atmospheric pressure: 700 to 1060 hPa
The HLX 3000 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.
OPERATION
MAINTENANCE1.7
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.
USER MANUAL1.8
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.
FCC PART 151.9
MAQUET SA
Parc de Limère
Avenue de la Pomme de Pin
CS 10008 ARDON
45074 ORLÉANS CEDEX 2
FRANCE
Telephone: [phone]
Fax: [phone]
www.maquet.com
MANUFACTURED BY1.10
(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.

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Figure 1
DESCRIPTION2
1 Main arm
2 Spring arm
3 Comfort bracket
4 Fresnel lens
5 Sterilisable handle
6 Side positioning handle
7 Underside
8 Shell
9 Cover
10 Lamp holder
11 Optional dimmer
12 Power on/off
13 Keypad used to increase lighting level
14 Keypad used to decrease lighting level
15 LED-indicator of the lighting level
16 Indicator of normal operation
EXAMPLE OF DOUBLE CONFIGURATION2.1
1
2
3
6
8
10
49
5
7
14
13
11
12
16
15

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HLX 3000 PRODUCT RANGE2.2
HLX 3003 HLX 3005
HLX 3004 TV
pre-wired for a HANAUVISION camera
The HLX 3000 surgical lighting system is available in three different versions: