Instructions for Use
60 Pages
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Instructions for use Lucea 50-100
IFU 01741 EN 10 2021-11-17
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 developments, differ slightly from the actual product supplied.
V10 17.11.2021
LUCEA 50-100 IFU 01741 EN 10
Contents
Contents 1
Introduction ...
7
1.1
Preface ...
7
1.2
Information about this document ... 1.2.1 Abbreviations ... 1.2.2 Symbols used in this manual ... 1.2.2.1 Cross-references... 1.2.2.2 Reference numbers... 1.2.2.3 Actions and results ... 1.2.2.4 Menus and buttons... 1.2.3 Definitions ... 1.2.3.1 Hazard levels... 1.2.3.2 Indications ... 1.2.3.3 Groups of people... 1.2.3.4 Light types ...
7 7 7 7 7 8 8 8 8 8 9 9
1.3
Other documents relating to this product...
9
1.4
Liability...
10
1.5
Expected service lifetime ...
10
1.6
Warranty ...
10
1.7
Symbols on the product and packaging ...
11
1.8
Location and explanation of the device identification label...
12
1.9
Product overview ... 1.9.1 Components... 1.9.1.1 Lightheads... 1.9.2 Accessories...
13 16 16 17
1.10 Standards applied...
18
1.11 Information relating to intended use ... 1.11.1 Intended use ... 1.11.2 Intended users ... 1.11.3 Inappropriate use ... 1.11.4 Contraindications ...
20 20 20 20 20
1.12 Primary purpose ...
21
1.13 Clinical benefit ...
21
1.14 Instructions for reducing the environmental impact ...
21
2
Safety-related information... 22
2.1
Environmental conditions ...
22
2.2
Safety instructions ... 2.2.1 Safe use of the product... 2.2.2 Electrical ... 2.2.3 Optical... 2.2.4 Infection ...
22 22 24 24 24
LUCEA 50-100 IFU 01741 EN 10
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Contents
3
Control interfaces ... 25
4
Use... 26
4.1
Daily inspections before use...
26
4.2
Controlling the light ... 4.2.1 Turning the light on and off ... 4.2.2 Adjusting the illumination ... 4.2.2.1 From the lighthead control keypad ... 4.2.2.2 From the remote control ...
28 28 28 28 29
4.3
Controlling the camera (not sold since January 2019) ...
30
4.4
Positioning the light ... 4.4.1 Installing/removing the sterilisable handle ... 4.4.2 Manoeuvring the lighthead... 4.4.3 Pre-positioning examples...
31 31 32 35
4.5
Remote control ... 37 4.5.1 Registering the remote control with the light... 37 4.5.2 Changing the remote control batteries... 38
4.6
Mobile light ... 4.6.1 Moving a mobile light ... 4.6.2 Battery system operation ... 4.6.3 Battery state... 4.6.4 Mobile light pre-positioning example...
5
Error messages and alarm indicators... 43
6
Troubleshooting... 44
7
Cleaning / Disinfection / Sterilisation... 46
7.1
Cleaning and disinfecting the system ... 7.1.1 Cleaning the device ... 7.1.2 Disinfecting the device ... 7.1.2.1 Disinfectants to be used ... 7.1.2.2 Permitted active substances ...
46 46 47 47 47
7.2
Cleaning and sterilising STG HLX sterilisable handles ... 7.2.1 Preparation for cleaning... 7.2.2 Manual cleaning... 7.2.3 Cleaning in a washer-disinfector... 7.2.4 Sterilisation ...
48 48 48 48 49
8
Maintenance ... 50
8.1
Maintenance schedule...
50
8.2
Contact ...
50
9
Technical specifications... 51
9.1
Optical specifications ...
51
9.2
Electrical characteristics ...
54
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39 39 40 41 42
LUCEA 50-100 IFU 01741 EN 10
Contents
9.3
Mechanical specifications ... 54 9.3.1 Light ... 54
9.4
Other characteristics...
55
9.5
EMC declaration ...
55
10
Waste management ... 58
10.1 Disposal of packaging ...
58
10.2 Product ...
58
10.3 Electrical and electronic components ...
58
LUCEA 50-100 IFU 01741 EN 10
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Contents
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LUCEA 50-100 IFU 01741 EN 10
Introduction
1
Preface
1
Introduction
1.1
Preface Your hospital has chosen Getinge's innovative medical technology. We thank you for the confidence 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 hospitals. 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 IFU IP K LED lx N/A
Electromagnetic compatibility Instructions For Use Ingress Protection rating Kelvin Light-Emitting Diode lux 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 .
LUCEA 50-100 IFU 01741 EN 10
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1 1.2.2.3
Introduction Information about this document
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. Example: Prerequisites: •
The sterilisable handle must be compatible with the product.
1. Fit the handle to the mount. Ø A 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. Ø The 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
Tab. 1:
1.2.3.2
Hazard level
Meaning
DANGER!
Indicates a direct and immediate risk that may be fatal or cause very serious injuries potentially leading 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.
Hazard levels of safety instructions
Indications Symbol
Indication type NOTICE
ENVIRONMENT
Tab. 2:
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Meaning Additional assistance or useful information not relating to risks of injuries or risks of material damage.
Information relating to recycling or to appropriate disposal of waste.
Types of indication in the document
LUCEA 50-100 IFU 01741 EN 10
Introduction
1
Other documents relating to this product
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 intended. 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, personnel must hold the necessary authorisation in order to be considered as qualified.
1.2.3.4
Light types Minor surgical light Single light located in the patient’s environment in an operating room and designed to facilitate treatment and diagnosis procedures which can be interrupted without compromising patient safety in the event of a light failure. Surgical lighting system Combination of several surgical lights designed to facilitate treatment and diagnosis operations and to be used in operating rooms. A surgical lighting system must be failsafe and must provide adequate central illumination to light the body of the patient locally even if an initial fault condition occurs. Example: A combination of at least two minor surgical lights constitutes a surgical lighting system.
1.3
Other documents relating to this product • • • •
LUCEA 50-100 IFU 01741 EN 10
Repair manual (Ref. ARD01742) Installation manual (Ref. ARD01744) Maintenance manual (Ref. ARD01740) Decommissioning procedure (Ref. P_0174801)
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1
Introduction Liability
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 personnel, 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 installed on the system. The compatibility data is detailed in the chapter entitled Technical specifications [8 Page 51]. 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.
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 personnel trained and approved by Getinge; see Maintenance schedule [8 Page 50]. After this time, if the device is still in use, an inspection must be carried out by personnel trained and approved by Getinge to ensure the continued safety of the device.
1.6
Warranty For details of warranty conditions, please contact your local Getinge representative.
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LUCEA 50-100 IFU 01741 EN 10
Introduction Symbols on the product and packaging
1.7
1
Symbols on the product and packaging
LUCEA 50-100 IFU 01741 EN 10
Follow the instructions for use (IEC 60601-1:2012)
Risk of toppling: Do not push the mobile light or lean on it when the casters are locked.
Follow the instructions for use (IEC 60601-1:2005).
CE marking (Europe)
Follow the instructions for use (IEC 60601-1:1996).
UL mark (Canada and United States)
Manufacturer + manufacturing date
Medical Device (MD) marking
Product code
Unique device identification
Product serial number
Packaging orientation
AC input
Fragile, handle with care
Operation
Keep away from the rain
Stopped
Temperature range for storage
Do not discard with conventional waste
Humidity range for storage
Equipotential grounding connector
Ambient pressure range for storage
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1
Introduction Location and explanation of the device identification label
1.8
Location and explanation of the device identification label
Fig. 1:
Location of the product identification label
3
4 Made in France
MAQUET SAS
2 1 5
YYYY-MM-DD
Parc de Limère-Avenue de la Pomme de Pin CS 10008 Ardon - 45074 Orléans cedex 2 - France
ARDLCAXXXXXX
LCA XXXXXXXXXXXXXXXX Lucea
XXXXXX
(XX)XXXXXXXXXXXXXX(XX)XXXXXX(XX)XXXXXX(XXX)ARDLCAXXXXXX(XX)XXXXXXXX
AC 100-240 V 50/60 Hz 180 VA ANSI/AAMI ES60601-1 :2005 + AMD (2012) CAN/CSA-C22.2 NO. 60601-1 :2014 IEC 60601-2-41 :2009
Fig. 2:
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E346609
Example label
1
Product name
4
Serial No.
2
Manufacturing date
5
Unique device identifier (UDI)
3
Product code
LUCEA 50-100 IFU 01741 EN 10
Introduction Product overview
1.9
1
Product overview 3
1 3
2
4
4
5 8
7
5 6
8 Fig. 3:
LUCEA 50-100 IFU 01741 EN 10
Typical ceiling-mounted configuration
1
Ceiling cover
5
Double fork
2
Suspension tube
6
LUCEA* 100 lighthead
3
Extension arm
7
LUCEA 50 lighthead
4
DF spring arm
8
STG HLX sterilisable handle
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1
Introduction Product overview
1 3 4 2
5 Fig. 4:
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6
Typical wall-mounted configuration
1
Wall bracket
4
Single fork
2
Extension arm
5
LUCEA 50 lighthead
3
SF spring arm
6
STG HLX sterilisable handle
LUCEA 50-100 IFU 01741 EN 10
Introduction
1
Product overview
4
4 5
2
1
3
3 5
6
7
8 8 9
Fig. 5:
LUCEA 50-100 IFU 01741 EN 10
9
Typical mobile configurations
1
LUCEA 50 lighthead
6
Power supply without backup
2
LUCEA 100 lighthead
7
Power supply with backup
3
STG HLX sterilisable handle
8
Stand base
4
SF spring arm
9
Casters
5
Pole
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1
Introduction Product overview
1.9.1
Components
1.9.1.1
Lightheads
Fig. 6:
LUCEA 50 and LUCEA 100 lightheads
Each lighthead comprises the following elements: • On/Off button • A dimmer to vary the light intensity • Sterilisable handle The LUCEA 100 lighthead features a system for varying the diameter of the light field by turning the sterilisable handle. FSP function for better electronic management of illumination
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Introduction Product overview
1.9.2
1
Accessories CA UTI ON ! 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 electromagnetic emissions or a decreased immunity of this device, and may result in improper operation. Use only accessories and cables supplied or specified by the manufacturer.
Remote control This remote control enables the light to be controlled at a distance, as needed by the surgeon, from anywhere in the operating room.
1
Fig. 7:
2
LUCEA remote control
NO TE The video camera compatible with the LUCEA 100 lightheads is no longer available since January 2019.
NO TE The remote control has a range of 10 m.
Sterilisable handle Illustration
Description Set of five STG HLX handles
LUCEA 50-100 IFU 01741 EN 10
Code STG HLX 01
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1
Introduction Standards applied
Power supply cables, mobile version Item
Description
Part number
Length
POWER CORD EUR
Power supply cable for Europe
5 686 04 960
4m
POWER CORD EUR
Power supply cable for the UK
5 686 04 961
4m
POWER CORD US
Power supply cable for the US
5 686 04 967
4m
POWER CORD BRA
Power supply cable for Brazil
5 686 04 963
4m
POWER CORD JPN
Power supply cable for Japan
5 686 04 966
4m
POWER CORD CHE
Power supply cable for Switzerland
5 686 04 965
4m
POWER CORD AUS
Power supply cable for Australia
5 686 04 964
4m
POWER CORD ITA
Power supply cable for Italy
5 686 04 962
4m
POWER CORD ARG
Power supply cable for Argentina
5 686 04 968
2m
Tab. 3:
1.10
Power supply cables
Standards applied The device complies with the safety requirements of the following standards and directives: Standards
Year
Title
Directive 93/42/EEC
1993
Medical devices directive (Annex VII)
Directive 2014/53/EU
2014
Radio equipment directive
IEC 60601-1+A1 EN 60601-1+A1 IEC 60601-1+A1+A2+3 IEC 60601-1-1
2012 2013 1996 2000
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-4+A1
1999
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – Collateral standard: Programmable electrical medical systems
ANSI/AAMI ES60601-1+A1
2005 + UL/cUL rating concerning electric shock, mechanical haz2012 ards and fire risks.
UL 60601-1 CSA CAN/CSA-C22.2 NO. 60601-1
2014
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (standard IEC 60601-1+A1:2012, with specific requirements for Canada)
IEC 60601-1-2 EN 60601-1-2 IEC 60601-1-2
2014 2015 2007
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests
IEC 60601-1-6 EN 60601-1-6
2010 2010
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
Tab. 4:
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UL/cUL rating concerning electric shock, mechanical hazards and fire risks.
Compliance with product standards
LUCEA 50-100 IFU 01741 EN 10
Introduction Standards applied
1
Standards
Year
Title
IEC 60601-2-41 EN 60601-2-41
2009 2009
Medical electrical equipment – Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
IEC 62304 EN 62304/AC
2006 2008
Medical device software – Software life cycle processes
IEC 62311 EN 62311
2007 2008
Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (0 Hz – 300 GHz)
IEC 62366 EN 62366
2007 2008
Medical devices – Application of usability engineering to medical devices
FCC Part 15
2008
Radio frequency device
IEC 62471 EN 62471
2006 2008
Photobiological safety of lamps and lamp systems
Tab. 4:
Compliance with product standards
Quality management: Standards
Year
Title
EN ISO 13485 ISO 13485
2016 2016
Medical devices – Quality management systems – Requirements for regulatory purposes
EN ISO 14971 ISO 14971
2012 2007
Medical devices – Application of risk management to medical devices
Tab. 5:
Compliance with quality management standards
Environmental standards and regulations: Standards
Year
Title
Directive 2011/65/UE RoHS2
2011
Limitation of the use of certain hazardous substances in electrical and electronic equipment
Directive 2015/863 RoHS3
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
REACH regulation No. 190
2006
Registration, evaluation and authorization of chemical substances, as well as the restrictions applicable to these substances
Prop. 65
1986
The Safe Drinking Water and Toxic Enforcement Act of 1986
Chinese RoHS Tab. 6:
LUCEA 50-100 IFU 01741 EN 10
China order No. 39, Administration of the Control and Electronic Information Products
Environmental standards and regulations
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1
Introduction Information relating to intended use
Other information (for China only) 产品名称：手术无影灯 规格型号：见标签 医疗器械注册证编号：国械注进20192010303 产品技术要求编号：国械注进20192010303 产品组成：由灯头（含发光二极管灯泡、调光器、灯罩）、电源箱、支架、手术灯头吊臂、摄像头 （选配，后缀带V的型号适用）及其遥控器（选配，后缀带V的型号适用）组成。 适用范围：该产品为吊顶式安装，供医疗单位作医用手术照明用。 禁忌症：无。 生产日期：见标签 使用期限：10年 注册人/生产企业名称：Maquet SAS 迈柯唯股份有限公司 注册人/生产企业住所：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 代理人名称：迈柯唯（上海）医疗设备有限公司 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 代理人联系方式：800-820-0207 修订日期：见本说明书第二页
1.11
Information relating to intended use
1.11.1
Intended use LUCEA 50 and LUCEA 100 lightheads are surgical lights designed to illuminate the body of a patient during surgical operations, diagnostics and treatment.
1.11.2
Intended users • •
1.11.3
The device may be operated only by medical staff who have read this manual. The device must be cleaned by qualified personnel.
Inappropriate use The device must be used: • As a major light system (two or three lightheads) for all operations performed on patients, with or without risk. • As a minor light system (one lighthead) only if the operation may be interrupted without endangering the patient’s life (e.g. diagnostic procedure). • On mains power for normal use of a mobile light. Inappropriate use: • Use of a damaged product (e.g. lack of maintenance). • In a setting other than a professional healthcare environment (e.g. home care). • Use of the mobile light on battery power (intended for emergency use only).
1.11.4
Contraindications This product does not have any contraindications.
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