Getinge MAQUET X'TEN User manual

X‘TEN | User manual | EN | 0130103 | 3A |
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USER MANUAL - EN

X'TEN | User manual | EN | 0130103 | 3A |
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 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.
31 October 2012 | Ed3A| Ed3A| Ed3AEd3A

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CONTENTS
Quality standards compliance | 4
Certification of MAQUET SAS’s quality system | 4
CE marking | 4
Warnings | 5
Symbols used in this manual | 7
Symbols used on the product | 8
1Introduction | 9
2Description | 11
2.1 Example of double configuration | 11
2.2 Versions available | 12
3Use | 13
3.1 Energix WPS power supply unit | 13
3.2 Optional LCD | 14
3.3 Optional control via a remote PC | 14
3.4 Optional ambient light | 14
3.5 Optional backup power supply | 15
3.6 Optional video camera | 16
4Positioning | 17
4.1 Moving the lighthead | 17
4.2 Pre-positioning examples by speciality | 19
4.3 Degrees of rotation | 21
4.4 Fitting the sterilisable handle | 22
4.5 Fitting the single-use sterile handle
(Devon or Deroyal) | 22
5Cleaning / Disinfection / Sterilisation | 23
5.1 Cleaning and disinfecting the surgical light | 23
5.2 Cleaning and sterilising the handles | 24
6Maintenance | 26
6.1 First level maintenance | 26
6.2 Annual maintenance | 27
7Replacing the bulbs | 32
8Accessories | 33
9General characteristics | 34
10 EMC declaration | 35
11 Troubleshooting | 39

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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 9001:2000
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.
QUALITY STANDARDS COMPLIANCE
CERTIFICATION OF MAQUET SAS’S QUALITY SYSTEM

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Changes or modifications not expressly approved by MAQUET SAS 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
!
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.
WARNING
!
Check that the sterilisable/disposable handle is compatible with the product.
WARNING
!
Do not use the device in the presence of flammable anaesthetic gases.
WARNING
!

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In the event of a power cut, only lightheads connected to a backup power supply will remain
on.
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.
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
!
Do not store objects on the wall power supply units.
WARNING
!
To avoid all risk of asepsis, only the medical team may touch the sterilisable handle during
procedures.
WARNING
!
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.
AVERTISSEMENT
!
Contact between patient and non sterile parts of a device is forbidden.
To avoid any risk of an electric shock, class I devices must be connected to a power supply
system which is earthed.
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.

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SYMBOLS USED ON THE PRODUCT
Symbols Meaning
Caution
Follow the instructions for use
Read the documents supplied with unit carefully
Manufacturer
~Alternating current
Direct current
REF.
SN. Product technical description and serial numbers.
S
Comply with the applicable handling precautions for products that are
sensitive to electrostatic discharges.
23.5VRMS (VRMS
AC+DC)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
The X’TEN range is designed for use in medical applications to illuminate patients' bodies
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.
1.2 SPECIAL FEATURES
Excellent shadow dilution
Wide range of movement
Compatible with laminar flows
Incredible volume of light
LEDs for ambient light
Upgraded multimedia
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
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.
1.5 INTENDED EQUIPMENT
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.
1.6 ENVIRONMENTAL REQUIREMENTS

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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.
OPERATION
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
MAQUET SAS
Parc de Limère
Avenue de la Pomme de Pin
CS 10008 ARDON
45074 ORLÉANS CEDEX 2
FRANCE
Telephone: [phone]
Fax: [phone]
www.maquet.com
1.10 MANUFACTURED BY
(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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1
2
3
6
Figure 1
2 DESCRIPTION
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
8
10
4
9
5
7
13
12
11
2.1 EXAMPLE OF DOUBLE CONFIGURATION

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Standard version Simple surgical light
LED Version Surgical light + Ambient light
Video version Surgical light + Ambient light + Video prewiring
2.2 VERSIONS AVAILABLE
MAIN LIGHTING
for performing surgical procedures under the best conditions.
AMBIENT LIGHTING
for easy viewing of and around operating fields.

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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.
LED off Power supply off
Green LED Power supply on
Red LED Backup power supply on
(WPS XX1 only)
Illumination
adjustment
To change levels, press once or press and
hold.
8 illumination levels
(2 per LED)
Flashing yellow LED
Bulb failure or
Ambient light
3 USE
3.1 ENERGIX WPS POWER SUPPLY UNIT
Do not store objects on the wall power supply units.
WARNING
!
The light is turned on and off via the ENERGIX WPS 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.
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™).
3.3 OPTIONAL CONTROL VIA A REMOTE PC
Use the keypad on the lighthead fork to toggle between lighting modes.
Light turned on via the
ENERGIX unit
Link not operational
Settings are adjusted via
the ENERGIX unit
Light turned on via
the PC
Operational link
Settings are adjusted via
the PC
3.4 OPTIONAL AMBIENT LIGHT
!
The link will be cut if
adjustments are made via
the ENERGIX unit.

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The power supplies may be optionally equipped for use with your operating room's 24 V
backup power supply.
If the mains supply is restored after being cut, the light turns on in surgical light mode.
3.5 OPTIONAL BACKUP POWER SUPPLY
In the event of a power cut, only lightheads connected to a backup power supply will remain
on.
WARNING
!
Red LED Backup power supply on
(WPS XX1 only)
BATTERY BACKUP TEST (DAILY CHECK)
Turn on the lighthead.
Press and hold the On/Off button for 3 seconds.
The backup batteries take over.
The LED turns from green to red.
The lighthead automatically switches back to the mains supply 3
seconds later.
BATTERY CAPACITY TEST (MONTHLY CHECK)
Press and hold the «+», «-» buttons and the On/Off button for
2 seconds.
The backup batteries take over.
Allow the batteries to discharge (one hour per lighthead).
BATTERY GOOD
Battery charge sufficient.
BATTERY BAD
Replace the batteries.
Press the On/Off button to interrupt the test or to switch back to the
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.
The camera turns on when the lighthead is switched on.
PRV-CFF camera
A sterilisable handle with viewing window is required to
use the 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.
USE
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.).
Use the removable handle at the centre or
the handle on the side to position the
lighthead.
Recommended distance between the
underside and the operating field: 1 m.
1 m
Do not direct the lighthead towards the ceiling while the
light is on. Doing so could damage certain internal parts.
RECOMMENDATION
F

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To avoid all risk of asepsis, only the medical team may touch the sterilisable handle during
procedures.
WARNING
!
Do not use the light suspension system to carry or raise objects.
Do not hang from the light.
RECOMMENDATION
F
Turn the handle to adjust the light volume to
the needs of the procedure. The range of the
adjustment is limited by stops.
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.
LIGHTHEAD WITHOUT CAMERA
LIGHTHEAD WITH CAMERA

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Pre-positioning
examples
Surgical
specialities
General
surgery
Urology,
organ transplants,
gynaecology,
delivery
General surgery,
abdominal surgery, digestive surgery,
thoracic surgery
Proctology
4.2 PRE-POSITIONING EXAMPLES BY SPECIALITY
Figure 1
Figure 2
Figure 3
Figure 4

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Pre-positioning
examples
Surgical
specialities
Neurosurgery
Plastic and
reconstructive surgery,
face transplants,
oral and maxillofacial surgery
Otolaryngology,
ophthalmology,
dermatology
Figure 5
Figure 6
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.