Getinge LUCEA 10 User manual

Instructions for use
LUCEA 10-40
IFU 01701EN 122022-11-21

Copyright
All rights reserved. This document may not be copied, adapted or translated without prior written permission,
except as permitted under copyright law.
© Copyright 2021 Maquet SAS
Subject to technical changes.
The illustrations and technical specifications provided in this manual may, on account of future product devel-
opments, differ slightly from the actual product supplied.
V12 21.11.2022
LUCEA 10-40
IFU 01701 EN 12

Contents
LUCEA 10-40
IFU 01701 EN 12 3 / 38
Contents
1 Introduction .............................................................................................................. 5
1.1 Preface ................................................................................................................................................. 5
1.2 Information about this document .......................................................................................................... 5
1.2.1 Abbreviations ......................................................................................................................... 5
1.2.2 Symbols used in this manual ................................................................................................. 5
1.2.2.1 Cross-references................................................................................................. 5
1.2.2.2 Reference numbers............................................................................................. 5
1.2.2.3 Actions and results .............................................................................................. 5
1.2.2.4 Menus and buttons.............................................................................................. 6
1.2.3 Definitions .............................................................................................................................. 6
1.2.3.1 Hazard levels....................................................................................................... 6
1.2.3.2 Indications ........................................................................................................... 6
1.2.3.3 Groups of people................................................................................................. 7
1.2.3.4 Type of light......................................................................................................... 7
1.3 Other documents relating to this product.............................................................................................. 7
1.4 Liability.................................................................................................................................................. 7
1.5 Expected service lifetime...................................................................................................................... 8
1.6 Warranty ............................................................................................................................................... 8
1.7 Symbols on the product and packaging ............................................................................................... 8
1.8 Location and explanation of the device identification label................................................................... 9
1.9 Product overview .................................................................................................................................. 10
1.9.1 Accessories............................................................................................................................ 13
1.10 Standards applied................................................................................................................................. 14
1.11 Information relating to intended use ..................................................................................................... 17
1.11.1 Intended use .......................................................................................................................... 17
1.11.2 Intended users ....................................................................................................................... 17
1.11.3 Inappropriate use ................................................................................................................... 17
1.11.4 Contraindications ................................................................................................................... 17
1.12 Primary purpose ................................................................................................................................... 17
1.13 Clinical benefit ...................................................................................................................................... 17
1.14 Instructions for reducing the environmental impact .............................................................................. 18
2 Safety-related information....................................................................................... 19
2.1 Environmental conditions ..................................................................................................................... 19
2.2 Safety instructions ................................................................................................................................ 19
2.2.1 Safe use of the product.......................................................................................................... 19
2.2.2 Electrical ................................................................................................................................ 20
2.2.3 Optical.................................................................................................................................... 20
3 Control interfaces ................................................................................................... 21
4 Use............................................................................................................................. 22
4.1 Daily inspections before use................................................................................................................. 22
4.2 Positioning the light .............................................................................................................................. 23

Contents
4 / 38 LUCEA 10-40
IFU 01701 EN 12
4.3 Turning the light on and off................................................................................................................... 24
4.4 Manoeuvring the lighthead ................................................................................................................... 25
5 Error messages and alarm indicators.................................................................... 27
6 Troubleshooting....................................................................................................... 28
7 Cleaning / Disinfection / Sterilisation..................................................................... 29
7.1 Cleaning and disinfecting the system ................................................................................................... 29
7.1.1 Cleaning the device ............................................................................................................... 29
7.1.2 Disinfecting the device ........................................................................................................... 30
7.1.2.1 Disinfectants to be used ...................................................................................... 30
7.1.2.2 Permitted active substances ............................................................................... 30
8 Maintenance ............................................................................................................. 31
8.1 Maintenance schedule.......................................................................................................................... 31
8.2 Contact ................................................................................................................................................. 31
9 Technical specifications.......................................................................................... 32
9.1 Optical specifications............................................................................................................................ 32
9.2 Electrical characteristics ....................................................................................................................... 32
9.3 Mechanical specifications..................................................................................................................... 33
9.4 Other characteristics............................................................................................................................. 33
9.5 EMC declaration ................................................................................................................................... 33
9.5.1 FCC Part 15 (USA only)......................................................................................................... 35
10 Waste management ................................................................................................. 36
10.1 Disposal of packaging .......................................................................................................................... 36
10.2 Product ................................................................................................................................................. 36
10.3 Electrical and electronic components ................................................................................................... 36

Introduction
Preface 1
LUCEA 10-40
IFU 01701 EN 12 5 / 38
1 Introduction
1.1 Preface
Your hospital has chosen Getinge's innovative medical technology. We thank you for the confid-
ence you have shown in us.
Getinge is one of the world’s leading suppliers of medical equipment for operating rooms, hybrid
rooms, induction rooms, intensive care units and patient transport. Getinge always puts the
needs of healthcare staff and patients first during the development of its products. Getinge
provides solutions that respond to the safety, efficiency and economic constraints faced by hos-
pitals.
Building on its experience in surgical lights, ceiling-mounted equipment management systems
and multimedia solutions, Getinge focuses on quality and innovation to ensure that its solutions
best meet the needs of patients and healthcare staff. Getinge surgical lights are world-renowned
for their design and innovative features.
1.2 Information about this document
This user’s manual is intended for day-to-day users of the product, staff supervisors and hospital
authorities. It is intended to familiarise users with the design, safety features and operation of the
product. The manual is organised and divided into several separate chapters.
Please note:
• Please read the user's manual thoroughly and in full before using the product for the first
time.
• Always proceed in line with the instructions in the user’s manual.
• Keep this manual close to the equipment.
1.2.1 Abbreviations
EMC Electromagnetic compatibility
IFU Instructions For Use
IP Ingress Protection rating
K Kelvin
LED Light-Emitting Diode
lx lux
N/A Not Applicable
1.2.2 Symbols used in this manual
1.2.2.1 Cross-references
References to other pages of the manual are identified by the “ ” symbol.
1.2.2.2 Reference numbers
Reference numbers in illustrations and text are shown in a square box 1.
1.2.2.3 Actions and results
Actions to be performed by the user are listed with sequence numbers; the “ ” symbol is used to
show the result of an action.

1Introduction
Information about this document
6 / 38 LUCEA 10-40
IFU 01701 EN 12
Example:
Prerequisites:
• The sterilisable handle must be compatible with the product.
1. Fit the handle to the mount.
ØA click is heard.
2. Turn the handle until it locks into place with a second click.
1.2.2.4 Menus and buttons
Menu and button names are shown in bold.
Example:
1. Press the Save button.
ØThe changes are saved and the Favourites menu is displayed.
1.2.3 Definitions
1.2.3.1 Hazard levels
The text in safety instructions describes types of risk and how to avoid them. Safety instructions
are classified into the following three levels:
Symbol Hazard level Meaning
DANGER! Indicates a direct and immediate risk that may be
fatal or cause very serious injuries potentially lead-
ing to death.
WARNING! Indicates a potential risk that may cause injuries,
health hazards or serious material damage leading
to injuries.
CAUTION! Indicates a potential risk that may cause material
damage.
Tab.1: Hazard levels of safety instructions
1.2.3.2 Indications
Symbol Indication type Meaning
NOTICE Additional assistance or useful information not relat-
ing to risks of injuries or risks of material damage.
ENVIRONMENT Information relating to recycling or to appropriate
disposal of waste.
Tab.2: Types of indication in the document

Introduction
Other documents relating to this product 1
LUCEA 10-40
IFU 01701 EN 12 7 / 38
1.2.3.3 Groups of people
Users
• Users are persons who are authorised to use the device, either by virtue of their qualifications
or as a result of receiving training from a qualified person.
• Users are responsible for the safe use of the device and for ensuring that it is used as inten-
ded.
Qualified personnel:
• Qualified personnel are persons who have acquired knowledge through specialised training
in medical technology or due to their professional experience and knowledge of the safety
rules relating to the tasks performed.
• In countries where certification is required to exercise a medico-technical profession, person-
nel must hold the necessary authorisation in order to be considered as qualified.
1.2.3.4 Type of light
Diagnostic light
Device used to locally illuminate the patient’s body in order to facilitate diagnostic or treatment
operations that can be interrupted without endangering the patient if the light fails. It is not inten-
ded for use in operating rooms.
1.3 Other documents relating to this product
• Maintenance manual (Ref. ARD01700)
• Repair manual (Ref. ARD01702)
• Installation manual (Ref. ARD01704)
• Decommissioning instructions (Ref. ARD01705)
1.4 Liability
Modifications to the product
The product must not be modified in any way without the prior written consent of Getinge.
Compliant use of the device
Getinge may not be held liable for any direct or indirect damage that results from actions not set
out in this user’s manual.
Installation and maintenance
Installation, maintenance and decommissioning operations must be performed by trained person-
nel, approved by Getinge.
Training on the device
Training must be provided directly on the device by personnel approved by Getinge.
Compatibility with other medical devices
Only medical devices approved in accordance with IEC 60601-1 or UL 60601-1 should be in-
stalled on the system.
The compatibility data is detailed in the chapter entitled Technical specifications [8Page32].
The compatible accessories are detailed in the chapter concerned.
In the event of an incident
Any serious incident occurring in connection with the device must be notified to the manufacturer
and the relevant authority of the member state in which the user and/or patient is based.

1Introduction
Expected service lifetime
8 / 38 LUCEA 10-40
IFU 01701 EN 12
1.5 Expected service lifetime
The expected service lifetime of the product is 10years.
This service lifetime does not apply to consumables such as sterilisable handles.
This 10-year service lifetime applies subject to annual periodic checks being performed by per-
sonnel trained and approved by Getinge; see Maintenance schedule [8Page31]. After this
time, if the device is still in use, an inspection must be carried out by personnel trained and ap-
proved by Getinge to ensure the continued safety of the device.
1.6 Warranty
For details of warranty conditions, please contact your local Getinge representative.
1.7 Symbols on the product and packaging
Follow the instructions for use
(IEC60601-1:2012).
Unique device identification
Follow the instructions for use
(IEC60601-1:2005).
UL mark (Canada and United States)
Follow the instructions for use
(IEC60601-1:1996).
CE marking (Europe)
Manufacturer + manufacturing date Packaging orientation
Product code Fragile, handle with care
Product serial number Keep away from the rain
AC input Temperature range for storage
Do not discard with conventional
waste
Humidity range for storage
Risk of toppling: Do not push the mo-
bile light or lean on it when the
casters are locked.
Ambient pressure range for storage
Medical Device (MD) marking

Introduction
Location and explanation of the device identification label 1
LUCEA 10-40
IFU 01701 EN 12 9 / 38
1.8 Location and explanation of the device identification label
Fig.1: Location of the product identification label
YYYY-MM-DD
LCA XXXXXXXXXXXXXXXX
MAQUET SAS
Parc de Limère-Avenue de la Pomme de Pin
CS 10008 Ardon - 45074 Orléans cedex 2 - France
Made in France
ARDLCAXXXXXX XXXXXX
Lucea
ANSI/AAMI ES60601-1 :2005 + AMD (2012)
CAN/CSA-C22.2 NO. 60601-1 :2014
IEC 60601-2-41 :2009
E346609
(XX)XXXXXXXXXXXXXX(XX)XXXXXX(XX)XXXXXX(XXX)ARDLCAXXXXXX(XX)XXXXXXXX
AC 100-240 V 50/60 Hz 40 VA
1
2
5
3 4
Fig.2: Example label
1 Product name
2 Manufacturing date
3 Product code
4 Serial No.
5 Unique device identifier (UDI)

1Introduction
Product overview
10 / 38 LUCEA 10-40
IFU 01701 EN 12
1.9 Product overview
1
2
3
4
5
6
Fig.3: Rail-mounted LUCEA 10
1 LUCEA 10 lighthead
2 Flexible fork
3 Power supply block
4 Power supply cable
5 Fastening handle
6 Rail mounting bracket
1
2
3
4
5
6
Fig.4: Wall-mounted LUCEA 10
1 LUCEA 10 lighthead
2 Flexible fork
3 Power supply block
4 Power supply cable
5 Fastening handle
6 Wall bracket
1
2
3
4
5
6
7
8
Fig.5: LUCEA 10 mobile
1 LUCEA 10 lighthead
2 Flexible fork
3 Power supply block
4 Power supply cable
5 Fastening handle
6 Pole
7 Mobile base
8 Casters with brakes

Introduction
Product overview 1
LUCEA 10-40
IFU 01701 EN 12 11 / 38
1
2
3
4
5
6
Fig.6: Ceiling-mounted LUCEA 40
1 Ceiling cover
2 Suspension tube
3 Extension arm
4 Spring arm
5 Fork
6 LUCEA 40 lighthead
1
234
5
Fig.7: Wall-mounted LUCEA 40
1 Wall bracket
2 Extension arm
3 Spring arm
4 Fork
5 LUCEA 40 lighthead

1Introduction
Product overview
12 / 38 LUCEA 10-40
IFU 01701 EN 12
12
3
4
5
6
7
Fig.8: LUCEA 40 mobile
1 Pole
2 Spring arm
3 Fork
4 LUCEA 40 lighthead
5 Power supply
6 Stand base
7 Casters with brakes

Introduction
Product overview 1
LUCEA 10-40
IFU 01701 EN 12 13 / 38
1.9.1 Accessories
CAUTION!
Risk of malfunction of the device
The use of accessories, transducers or cables other than those supplied or
recommended by the manufacturer of this device may cause increased elec-
tromagnetic emissions or a decreased immunity of this device, and may res-
ult in improper operation.
Use only accessories and cables supplied or specified by the manufacturer.
Article Name Part num-
ber
Length
POWER CORD C7
EUR
Lucea 10 power supply cable for Europe 5 686 02 901 3.5 m
POWER CORD C7
GBR
Lucea 10 power supply cable for the UK 5 686 02 904 3.5 m
POWER CORD C7
US JPN
Lucea 10 power supply cable for the USA
and Japan
5 686 02 900 3.5 m
POWER CORD C7
BRA
Lucea 10 power supply cable for Brazil 5 686 02 902 2 m
POWER CORD C7
AUS
Lucea 10 power supply cable for Australia 5 686 02 905 2 m
Tab.3: Lucea 10 power supply cables
Article Name Part num-
ber
Length
POWER CORD EUR Power supply cable for Europe 5 686 04 960 4 m
POWER CORD EUR Power supply cable for the UK 5 686 04 961 4 m
POWER CORD US Power supply cable for the US 5 686 04 967 4 m
POWER CORD BRA Power supply cable for Brazil 5 686 04 963 4 m
POWER CORD JPN Power supply cable for Japan 5 686 04 966 4 m
POWER CORD CHE Power supply cable for Switzerland 5 686 04 965 4 m
POWER CORD AUS Power supply cable for Australia 5 686 04 964 4 m
POWER CORD ITA Power supply cable for Italy 5 686 04 962 4 m
POWER CORD ARG Power supply cable for Argentina 5 686 04 968 2 m
Tab.4: Lucea 40 power supply cables

1Introduction
Standards applied
14 / 38 LUCEA 10-40
IFU 01701 EN 12
1.10 Standards applied
The device complies with the safety requirements of the following standards and directives:
Reference Title
IEC 60601-1:2005 +
AMD1:2012
ANSI/AAMI
ES60601-1:2005/(R)2012
CAN/CSA-C22.2 No.
60601-1:14
EN 60601-1:2006/A1:2013/
A12:2014
Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance
IEC
60601-2-41:2009+AMD1:2
013
EN 60601-2-41:2009/
A11:2011/A1:2015
Medical electrical equipment – Part 2-41: Particular requirements
for the safety of surgical luminaires and luminaires for diagnosis
IEC 60601-1-2:2014
EN 60601-1-2:2015
Medical electrical equipment – Part 1-2: General requirements for
safety – Collateral standard: Electromagnetic disturbances – Re-
quirements and tests
IEC
60601-1-6:2010+AMD1:20
13+AMD2:2020
EN 60601-1-6:2010/
A1:2015/A2:2021
Medical electrical equipment – Part 1-6: General requirements for
basic safety and essential performance – Collateral standard: Us-
ability
IEC
60601-1-9:2007+AMD1:
2013+AMD2:2020
EN 60601-1-9:2008/
A1:2014/A2:2020
Medical electrical equipment – Part 1-9: General requirements for
basic safety and essential performance – Collateral standard: Re-
quirements for an environmentally friendly design
IEC
62366-1:2015+AMD1:2020
EN 62366-1:2015/A1:2020
Medical devices – Part 1: Application of usability engineering to
medical devices
IEC
62304:2006+AMD1:2015
EN 62304:2006/A1:2015
Medical device software – Software life cycle processes
ISO 20417:2020
EN ISO 20417:2021
Medical devices - Information provided by manufacturer
ISO 15223-1:2021
EN ISO 15223-1:2021
Medical devices - Symbols to be used with information to be
provided by manufacturer - Part 1: General requirements
EN 62471:2008 Photobiological safety of lamps and lamp systems
IEC 62311:2019
EN 62311:2020
Assessment of electronic and electrical equipment related to hu-
man exposure restrictions for electromagnetic fields (0 Hz – 300
GHz)
Ordinance 384/2020 INMETRO Certification - Compliance assessment requirements for
equipment under Health Surveillance
Tab.5: Compliance with product standards

Introduction
Standards applied 1
LUCEA 10-40
IFU 01701 EN 12 15 / 38
Quality management:
Reference Year Title
ISO 13485
EN ISO 13485
2021
2021
ISO 13485:2016 / A11:2021
EN ISO 13485:2016/A11:2021
Medical devices – Quality management systems – Require-
ments for regulatory purposes
ISO 14971
EN ISO 14971
2019
2019
ISO 14971:2019
EN ISO 14971:2019
Medical devices – Application of risk management to med-
ical devices
21 CFR Part 11 2021 Title 21--Food And Drugs
Chapter I--Food and Drug Administration Department of
Health and Human Services
Subchapter A -- General
PART 11 - Electronic records, electronic signatures
21 CFR Part 820 2020 Title 21--Food And Drugs
Chapter I--Food and Drug Administration Department of
Health and Human Services
Subchapter H -- Medical Devices
PART 820 - Quality System Regulation
Tab.6: Compliance with quality management standards
Environmental standards and regulations:
Reference Year Title
Directive 2011/65/EU 2011 Limitation of the use of certain hazardous substances in
electrical and electronic equipment
Directive 2015/863 2015 Directive amending AnnexII of Directive 2001/65/EU of the
European Parliament and of the Council as regards the list
of substances subject to limitation
Directive 2016/585/EU 2016 Exemption for lead, cadmium, hexavalent chromium and
PBDEs on medical devices
Directive 2017/2102 2017 Limitation of the use of certain hazardous substances in
electrical and electronic equipment
IEC 63000 2022 Technical documentation for the assessment of electrical
and electronic products with respect to the restriction of haz-
ardous substances
Regulation 1907/2006 2006 Registration, evaluation and authorization of chemical sub-
stances, as well as the restrictions applicable to these sub-
stances
US California Proposi-
tion 65 Act
1986 The Safe Drinking Water and Toxic Enforcement Act of 1986
Directive 94/62/EC 1994 Packaging and Waste Management
SJ/T 11365-2006 2006 Administrative Measure on the Control of Pollution caused
by Electronic Information Products Chines RoHS (Restriction
of Hazardeous Substances)
Tab.7: Environmental standards and regulations

1Introduction
Standards applied
16 / 38 LUCEA 10-40
IFU 01701 EN 12
Country Reference Year Title
Argentina Dispocision
2318/2002
2002 Administración Nacional de Medicamentos, Ali-
mentos y Tecnología Médica - Registro de pro-
ductos Medicas - Reglamento
Australia TGA 236-2002 2019 Therapeutic Goods (Medical Devices) Regula-
tions 2002. Statutory Rules No. 236, 2002 made
under the Therapeutic Goods Act 1989
Brazil RDC 665/2022 2022 GMP Requirements for Medical Devices and IVDs
Brazil RDC 185/2001 2001 Technical regulation about the registration of
medical products at ANVISA, as well as its altera-
tion, revalidation, or cancellation
Canada SOR/98-282 2021 Medical Devices Regulations
China Regulation 739 2021 Regulation for the Supervision and Administration
of Medical Devices
EU Regulation
2017/745/EU
2017 Medical Devices Regulations
Japan MHLW Ordin-
ance: MO No.
169
2021 Ministerial Ordinance on Standards for Manufac-
turing Control and Quality Control for Medical
Devices and In-Vitro Diagnostics
South Korea Act 14330 2016 Medical Device Act
South Korea Decree 27209 2016 Enforcement Decree of Medical Act
South Korea Rule 1354 2017 Enforcement Rule of the Medical Act
Switzerland RS (Odim)
812.213
2020 Medical Devices Ordinance (MedDO) of 1 July
2020
Taiwan TPAA
2018-01-31
2018 Taiwanese Pharmaceutical Affairs Act
UK Act 2021 Medical Devices Regulations 2002 No.618
USA 21CFR Part 7 2017 Title 21--Food And Drugs
Chapter I--Food and Drug Administration Depart-
ment of Health and Human Services
Subchapter A -- General
PART 7 - Enforcement policy
USA 21CFR
Subchapter H
- Title 21--Food And Drugs
Chapter I--Food and Drug Administration Depart-
ment of Health and Human Services
Subchapter H -- Medical Devices
Tab.8: Compliance with market standards
Other information (for China only)
适用规格型号：Lucea 10 rail version; Lucea 10 desk version; Lucea 10 mobile version; Lucea 10
wall version, Lucea 40 mobile version, Lucea 40 Ceiling-mounted version
产品名称：手术辅助照明灯
规格型号：见标签
序列号：见标签
生产日期：见标签
性能结构及组成：通常由光源、灯架等组成。预期供手术辅助照明用，为不具备自动防故障功能的
照明灯具，不能单独用于手术。不具有无影效果。
预期用途：用于手术室手术辅助照明。

Introduction
Information relating to intended use 1
LUCEA 10-40
IFU 01701 EN 12 17 / 38
备案号：国械备20151610号
产品技术要求编号：国械备20151610号
注册人/生产企业名称：Maquet SAS 迈柯唯股份有限公司
备案人注册地址：Parc de Limère Avenue de la Pomme de Pin CS 10008 Ardon 45074 Orléans
Cedex 2-FRANCE
生产地址：Parc de Limère Avenue de la Pomme de Pin CS 10008 Ardon 45074 Orléans Cedex
2-FRANCE
售后服务单位/代理人名称：迈柯唯（上海）医疗设备有限公司
售后服务单位/代理人住所：中国（上海）自由贸易试验区美盛路56号2层227室
售后服务单位/代理人电话：800 820 0207
1.11 Information relating to intended use
1.11.1 Intended use
The LUCEA 10-40 lighthead is a medical examination light. It is designed to provide the addi-
tional light needed for close-up visual examinations.
1.11.2 Intended users
• The device may be operated only by medical staff who have read this manual.
• The device must be cleaned by qualified personnel.
1.11.3 Inappropriate use
• This light is not intended for use during surgical operations.
• This light must not be used if it is damaged (e.g. lack of maintenance).
• This light must not be used in a setting other than a professional healthcare environment (e.g.
home care).
1.11.4 Contraindications
This product does not have any contraindications.
1.12 Primary purpose
The primary purpose of the LUCEA 10-40 examination light is to illuminate the examination site
or region of interest whilst minimising the associated heat energy.
1.13 Clinical benefit
Surgical and examination lights are considered as complementary to invasive and non-invasive
treatment or diagnosis, and are essential to surgeons and healthcare staff for optimal vision.
The assistance they provide during surgical and examination procedures demonstrates their in-
direct clinical benefit. LED surgical lights offer several advantages over other technologies (e.g.
incandescent lighting).
When used appropriately, LED surgical lights will:
• Improve workspace comfort and visual performance by focusing the light where surgeons
and healthcare staff need it, while decreasing the heat released.
• Provide shadow management, which allows the medical staff to concentrate on surgery or
diagnosis.
• Offer improved lifespan, thereby reducing the risk of partial malfunction during surgery.
• Provide steady illumination throughout their use.
• Ensure accurate colour rendering of the various tissues illuminated.

1Introduction
Instructions for reducing the environmental impact
18 / 38 LUCEA 10-40
IFU 01701 EN 12
1.14 Instructions for reducing the environmental impact
To ensure optimum use of the device while limiting its impact on the environment, here are some
rules to follow:
• Reduce power consumption by switching off the device when not in use.
• Position the device correctly so as not to have to compensate for poor positioning by increas-
ing the lighting power.
• Follow the specified maintenance schedule in order to keep the level of environmental impact
as low as possible.
• For questions relating to waste treatment and device recycling, refer to the Waste manage-
ment [8Page36] chapter.
NOTE
Power consumption for the device is provided in chapter 9.2, Electrical specifica-
tions.
The device does not contain hazardous substances in accordance with RoHS
standards (see Tab.7) and Reach regulation.

Safety-related information
Environmental conditions 2
LUCEA 10-40
IFU 01701 EN 12 19 / 38
2 Safety-related information
2.1 Environmental conditions
Environmental conditions for transport and storage
Ambient temperature -10°C to +60°C
Relative humidity 20% to 75%
Atmospheric pressure 500hPa to 1060hPa
Tab.9: Environmental conditions for transport/storage
Environmental conditions for use
Ambient temperature +10 °C to +40 °C
Relative humidity 20% to 75%
Atmospheric pressure 500hPa to 1060hPa
Tab.10: Environmental conditions for use
See also
2EMC declaration [}33]
2.2 Safety instructions
2.2.1 Safe use of the product
WARNING!
Risk of tissue reaction
Light is a form of energy that, on account of certain wavelengths emitted,
may not be suitable for certain pathologies.
The user must be aware of the risks of using the light on subjects who are in-
tolerant to UV and/or infrared light, and on photosensitive subjects.
Before a procedure, please ensure that the light is compatible with this type
of pathology.
WARNING!
Risk of electric shock
If the outlet is not disconnected properly, damage to the power supply cable
may occur and live parts may become accessible.
Do not pull on the power lead to disconnect the mains outlet.
WARNING!
Risk of injury
The mobile light may tip over if a person leans on it.
Never lean on the mobile light.
WARNING!
Risk of injury
Intense magnetic fields can cause the light to malfunction or move unexpec-
tedly.
Do not use in an MRI environment.

2Safety-related information
Safety instructions
20 / 38 LUCEA 10-40
IFU 01701 EN 12
WARNING!
Risk of injury/infection
The use of a damaged device may lead to a risk of injury for users or a risk of
infection for patients.
Do not use a damaged device.
WARNING!
Risk of burns
This device is not explosion-proof. Sparks, which would not normally be haz-
ardous, may cause fires in oxygen-enriched atmospheres.
Do not use the device in environments rich in flammable gases or oxygen.
2.2.2 Electrical
CAUTION!
Risk of malfunction of the device
The use of accessories, transducers or cables other than those supplied or
recommended by the manufacturer of this device may cause increased elec-
tromagnetic emissions or a decreased immunity of this device, and may res-
ult in improper operation.
Use only accessories and cables supplied or specified by the manufacturer.
WARNING!
Risk of electric shock
Anyone not trained in installation, maintenance or decommissioning opera-
tions is exposed to the risk of injury or electric shock.
Installation, maintenance and decommissioning of the device or components
of the device must be performed by a Getinge technician or a Getinge-trained
service technician.
2.2.3 Optical
WARNING!
Risk of burns
The high intensity of the light source results in a risk of burns to the eye if
the user looks directly towards the lighthead.
The patient’s eyes must be protected during facial surgery. Users must not
look directly into the light source.