Getinge LUCEA 10 Instructions For Use Manual
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Instructions for use
LUCEA 10-40
IFU 01701 EN 12 2022-11-21

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Summary of Contents for Getinge LUCEA 10

  • Page 1 Instructions for use LUCEA 10-40 IFU 01701 EN 12 2022-11-21...
  • Page 2 © 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...
  • Page 3: Table Of Contents

    Safety instructions ..........................2.2.1 Safe use of the product......................19 2.2.2 Electrical ..........................20 2.2.3 Optical............................ 20 Control interfaces ....................21 Use..........................22 Daily inspections before use......................... Positioning the light ..........................LUCEA 10-40 3 / 38 IFU 01701 EN 12...
  • Page 4 Other characteristics..........................EMC declaration ........................... 9.5.1 FCC Part 15 (USA only)......................35 10 Waste management ....................36 10.1 Disposal of packaging .......................... 10.2 Product ..............................10.3 Electrical and electronic components ....................LUCEA 10-40 4 / 38 IFU 01701 EN 12...
  • Page 5: Introduction

    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.
  • Page 6: Menus And Buttons

    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 LUCEA 10-40 6 / 38 IFU 01701 EN 12...
  • Page 7: Groups Of People

    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.
  • Page 8: Expected Service Lifetime

    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.
  • Page 9: Location And Explanation Of The Device Identification Label

    AC 100-240 V 50/60 Hz 40 VA ANSI/AAMI ES60601-1 :2005 + AMD (2012) CAN/CSA-C22.2 NO. 60601-1 :2014 IEC 60601-2-41 :2009 E346609 Fig. 2: Example label Product name Serial No. Manufacturing date Unique device identifier (UDI) Product code LUCEA 10-40 9 / 38 IFU 01701 EN 12...
  • Page 10: Product Overview

    Introduction Product overview Product overview LUCEA 10 lighthead Flexible fork Power supply block Power supply cable Fastening handle Rail mounting bracket Fig. 3: Rail-mounted LUCEA 10 LUCEA 10 lighthead Flexible fork Power supply block Power supply cable Fastening handle Wall bracket Fig. 4:...
  • Page 11 Product overview Fig. 6: Ceiling-mounted LUCEA 40 Ceiling cover Spring arm Suspension tube Fork Extension arm LUCEA 40 lighthead Fig. 7: Wall-mounted LUCEA 40 Wall bracket Fork Extension arm LUCEA 40 lighthead Spring arm LUCEA 10-40 11 / 38 IFU 01701 EN 12...
  • Page 12 Introduction Product overview Fig. 8: LUCEA 40 mobile Pole Power supply Spring arm Stand base Fork Casters with brakes LUCEA 40 lighthead LUCEA 10-40 12 / 38 IFU 01701 EN 12...
  • Page 13: Accessories

    Japan POWER CORD C7 Lucea 10 power supply cable for Brazil 5 686 02 902 POWER CORD C7 Lucea 10 power supply cable for Australia 5 686 02 905 Tab. 3: Lucea 10 power supply cables Article Name Part num-...
  • Page 14: Standards Applied

    EN 62311:2020 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 LUCEA 10-40 14 / 38 IFU 01701 EN 12...
  • Page 15 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 LUCEA 10-40 15 / 38 IFU 01701 EN 12...
  • Page 16 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...
  • Page 17: Information Relating To Intended Use

    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.
  • Page 18: Instructions For Reducing The Environmental Impact

    [8 Page 36] chapter. 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. LUCEA 10-40 18 / 38 IFU 01701 EN 12...
  • Page 19: Safety-Related Information

    Never lean on the mobile light. AR NI NG Risk of injury Intense magnetic fields can cause the light to malfunction or move unexpec- tedly. Do not use in an MRI environment. LUCEA 10-40 19 / 38 IFU 01701 EN 12...
  • Page 20: Electrical

    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...
  • Page 21: Control Interfaces

    Control interfaces Control interfaces This product does not have a control interface. LUCEA 10-40 21 / 38 IFU 01701 EN 12...
  • Page 22: Use

    1. Press the ON/OFF button on the lighthead control keypad to turn on the light. 2. Check that all the LEDs are operating. 3. If a problem is noted, contact technical support. Fig. 11: Operation of LEDs LUCEA 10-40 22 / 38 IFU 01701 EN 12...
  • Page 23: Positioning The Light

    Positioning the light Positioning the light Lucea 10 Mobile and Lucea 10 Wall-Mounted 1. Connect the power outlet. 2. Check that the fastening handle is properly tightened. 3. For the mobile version, lock the brakes by 45° lowering the levers on the casters.
  • Page 24: Turning The Light On And Off

    1. Press the switch located at the rear of the lighthead to turn on the light. 2. Press the switch located at the rear of the lighthead again to turn off the light. LUCEA 10-40 24 / 38 IFU 01701 EN 12...
  • Page 25: Manoeuvring The Lighthead

    Manoeuvring the lighthead Manoeuvring the lighthead Fig. 16: Manoeuvring the lighthead 1. Use the handle to position the lighthead in order to illuminate the examination area. Fig. 17: Rotation of the Lucea 10 300° 180° Infinite 160° Fig. 18: Rotation of the ceiling-mounted Lucea 40...
  • Page 26 Manoeuvring the lighthead Fig. 19: Rotation of the wall-mounted Lucea 40 180° infinite 180° +45° / -50° 290° Fig. 20: Rotation of the Lucea 40 mobile 55° 180° 290° +65° / -45° LUCEA 10-40 26 / 38 IFU 01701 EN 12...
  • Page 27: Error Messages And Alarm Indicators

    Error messages and alarm indicators Error messages and alarm indicators Not applicable for this product. LUCEA 10-40 27 / 38 IFU 01701 EN 12...
  • Page 28: Troubleshooting

    Contact the Getinge technical department Ceiling structure unstable Contact the Getinge technical department Lighthead or suspension arm Fork brake incorrectly adjusted Contact the Getinge technical too loose or too stiff to man- department oeuvre Device too stiff to manoeuvre Mechanical lock...
  • Page 29: Cleaning / Disinfection / Sterilisation

    (soap solution) containing active substances such as detergents and phosphates. Do not use abrasive products, as these could damage the surfaces. 2. Remove the cleaner using a cloth moistened with water and then wipe with a dry cloth. LUCEA 10-40 29 / 38 IFU 01701 EN 12...
  • Page 30: Disinfecting The Device

    ▪ Ethylene diamine tetraacetic acid (2.5%) Tab. 13: Lists of active substances suitable for use Examples of commercially available products tested • ANIOS product®** : Surfa’Safe®** • Other products: 20% or 45% isopropyl alcohol LUCEA 10-40 30 / 38 IFU 01701 EN 12...
  • Page 31: Maintenance

    During the guarantee period, maintenance and inspec- tions must be performed by a Getinge technician or a Getinge-approved dealer. After this period, maintenance and inspections may be performed by a Getinge technician, a Getinge-approved dealer or a hospital technician trained by Getinge.
  • Page 32: Technical Specifications

    < 100 W/m² ̶ Radiant energy 3.9 mW/m²/lx ± 0.4 UV illumination ≤ 0.7 W/m² ̶ Tab. 15: Lucea 10 optical specifications Specifications Lucea 40 Tolerance Nominal light intensity at 1 m > 40,000 lx ̶ Light field diameter d10 at 1 m 22 cm ±...
  • Page 33: Mechanical Specifications

    EMDN code for mobile versions Z12010702 CE marking year 2009 Tab. 19: Other characteristics of the LUCEA 10-40 EMC declaration AU TION Risk of malfunction of the device If the device is used in conjunction with other equipment, its operation and performance may be affected.
  • Page 34 B defined in CISPR 11 is normally required), this device may not provide sufficient pro- tection for radio frequency communication services. The user may need to take corrective measures, such as relocating or re-orienting the device. LUCEA 10-40 34 / 38 IFU 01701 EN 12...
  • Page 35: Fcc Part 15 (Usa Only)

    Operation of this equipment in a residential area is likely to cause harmful interference, in which case the user will be required to suppress the interference at its own expense. LUCEA 10-40 35 / 38 IFU 01701 EN 12...
  • Page 36: Waste Management

    Do not dispose of this device as unsorted municipal waste. Take it to a collection facility for value enhancement, recycling or re-use. For full information relating to processing of the device once it is no longer in use, contact your local Getinge representative. 10.3 Electrical and electronic components All electrical and electronic components used during the life of the product must be processed in an environmentally friendly manner, in line with applicable local standards.
  • Page 37 Notes...
  • Page 38 *LUCEA LED, MAQUET, GETINGE and GETINGE GROUP are trademarks or registered trademarks of Getinge AB, its divisions or its subsidiaries. **SURFA'SAFE is a trademark or registered trademark of ANIOS Laboratories, its divisions or its subsidiaries. **ANIOS is a trademark or registered trademark of ANIOS Laboratories, its divisions or its subsidiaries.

This manual is also suitable for:

Lucea 40

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