Getinge Lucea 50 Instructions For Use Manual
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Getinge Lucea 50 Instructions For Use Manual

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Instructions for use
Lucea 50-100
IFU 01741 EN 11 2023-04-06

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  • Page 1 Instructions for use Lucea 50-100 IFU 01741 EN 11 2023-04-06...
  • 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. V11 06.04.2023 LUCEA 50-100 IFU 01741 EN 11...

  • Page 3: Table Of Contents

    Safety-related information..................23 Environmental conditions ........................Safety instructions ..........................2.2.1 Safe use of the product......................23 2.2.2 Electrical ..........................25 2.2.3 Optical............................ 25 2.2.4 Infection ..........................25 Control interfaces ....................26 LUCEA 50-100 3 / 60 IFU 01741 EN 11...
  • Page 4 Cleaning in a washer-disinfector.................... 48 7.2.4 Sterilisation ..........................49 Maintenance ......................50 Maintenance schedule.......................... Contact ..............................Technical specifications..................51 Optical specifications ..........................Electrical characteristics ........................Mechanical specifications ........................9.3.1 Light ............................54 Other characteristics..........................LUCEA 50-100 4 / 60 IFU 01741 EN 11...
  • Page 5 Contents EMC declaration ........................... 10 Waste management ....................58 10.1 Disposal of packaging .......................... 10.2 Product ..............................10.3 Electrical and electronic components ....................LUCEA 50-100 5 / 60 IFU 01741 EN 11...
  • Page 6 Contents LUCEA 50-100 6 / 60 IFU 01741 EN 11...

  • Page 7: 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 8: 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 50-100 8 / 60 IFU 01741 EN 11...

  • Page 9: Groups Of People

    Example: A combination of at least two minor surgical lights constitutes a surgical lighting sys- tem. Other documents relating to this product • Maintenance manual (Ref. ARD01740) • Repair manual (Ref. ARD01742) • Installation manual (Ref. ARD01744) • Decommissioning instructions (Ref. ARD01745) LUCEA 50-100 9 / 60 IFU 01741 EN 11...

  • Page 10: Liability

    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 11: Symbols On The Product And Packaging

    Fragile, handle with care Operation Keep away from the rain Stopped Temperature range for storage Do not discard with conventional Humidity range for storage waste Equipotential grounding connector Ambient pressure range for storage LUCEA 50-100 11 / 60 IFU 01741 EN 11...

  • Page 12: Location And Explanation Of The Device Identification Label

    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 E346609 Fig. 2: Example label Product name Serial No. Manufacturing date Unique device identifier (UDI) Product code LUCEA 50-100 12 / 60 IFU 01741 EN 11...

  • Page 13: Product Overview

    Introduction Product overview Product overview Fig. 3: Typical ceiling-mounted configuration Ceiling cover Double fork Suspension tube LUCEA* 100 lighthead Extension arm LUCEA 50 lighthead DF spring arm STG HLX sterilisable handle LUCEA 50-100 13 / 60 IFU 01741 EN 11...
  • Page 14 Introduction Product overview Fig. 4: Typical wall-mounted configuration Wall bracket Single fork Extension arm LUCEA 50 lighthead SF spring arm STG HLX sterilisable handle LUCEA 50-100 14 / 60 IFU 01741 EN 11...
  • Page 15 Introduction Product overview Fig. 5: Typical mobile configurations LUCEA 50 lighthead Power supply without backup LUCEA 100 lighthead Power supply with backup STG HLX sterilisable handle Stand base SF spring arm Casters Pole LUCEA 50-100 15 / 60 IFU 01741 EN 11...

  • Page 16: Components

    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 LUCEA 50-100 16 / 60 IFU 01741 EN 11...

  • Page 17: Accessories

    Fig. 7: LUCEA remote control The remote control has a range of 10 m. Sterilisable handle Illustration Description Code Set of five STG HLX handles STG HLX 01 LUCEA 50-100 17 / 60 IFU 01741 EN 11...

  • Page 18: Standards Applied

    Medical electrical equipment – Part 1-9: General requirements for 60601-1-9:2007+AMD1: basic safety and essential performance – Collateral standard: Re- 2013+AMD2:2020 quirements for an environmentally friendly design EN 60601-1-9:2008/ A1:2014/A2:2020 Tab. 4: Compliance with product standards LUCEA 50-100 18 / 60 IFU 01741 EN 11...
  • Page 19 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 Tab. 6: Environmental standards and regulations LUCEA 50-100 19 / 60 IFU 01741 EN 11...
  • Page 20 Enforcement Decree of Medical Act South Korea Rule 1354 2017 Enforcement Rule of the Medical Act Switzerland RS (Odim) 2020 Medical Devices Ordinance (MedDO) of 1 July 812.213 2020 Tab. 7: Compliance with market standards LUCEA 50-100 20 / 60 IFU 01741 EN 11...

  • Page 21: Information Relating To Intended Use

    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 pa- tient during surgical operations, diagnostics and treatment. 1.11.2 Intended users • The device may be operated only by medical staff who have read this manual.

  • Page 22: Inappropriate Use

    Contraindications This product does not have any contraindications. 1.12 Primary purpose The primary purpose of the LUCEA 50-100 surgical light is to illuminate the surgical site 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.

  • Page 23: Safety-Related Information

    If the battery discharges too quickly, a lighthead may go out during a proced- ure. Perform a battery lifetime test monthly to estimate the battery lifetime. Con- tact the Getinge technical department if a malfunction occurs. AR NI NG Risk of tissue reaction Light is a form of energy that, on account of certain wavelengths emitted, may not be suitable for certain pathologies.
  • Page 24 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. LUCEA 50-100 24 / 60 IFU 01741 EN 11...

  • Page 25: 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. AR NI NG...

  • Page 26: Control Interfaces

    Control interfaces Control interfaces Fig. 8: LUCEA 50-100 control interfaces Lighthead control keypad Remote control LUCEA 50-100 26 / 60 IFU 01741 EN 11...

  • Page 27: Use

    2. Place the system in various positions. Ø The entire system should remain in the selected position, without any drift. 3. If a problem is noted, contact technical support. Fig. 11: Stability/drift LUCEA 50-100 27 / 60 IFU 01741 EN 11...
  • Page 28 2. Check that the IEC mains connector on the power supply enclosure cover is cor- rectly connected 3. If a problem is noted, contact technical support. Fig. 14: Power lead for mobile version LUCEA 50-100 28 / 60 IFU 01741 EN 11...

  • Page 29: Controlling The Light

    Adjusting the light field diameter (on LUCEA 100 only) 1. Turn the handle clockwise to enlarge the light field or counter-clockwise to re- duce the light field. Fig. 17: Adjusting the light field diameter LUCEA 50-100 29 / 60 IFU 01741 EN 11...

  • Page 30: From The Remote Control

    1. After selecting the lighthead(s), press Increase intensity to increase the light intensity level of the lighthead(s). 2. After selecting the lighthead(s), press Decrease intensity to decrease the light intensity level of the lighthead(s). LUCEA 50-100 30 / 60 IFU 01741 EN 11...

  • Page 31: Controlling The Camera (Not Sold Since January 2019)

    Adjusting the camera zoom 1. Press Increase Zoom or Decrease Zoom to adjust the camera zoom. Adjusting the image position 1. Press Rotate camera to adjust the image position from 0° to 180°. LUCEA 50-100 31 / 60 IFU 01741 EN 11...

  • Page 32: Positioning The Light

    Ø The handle is now locked in place and ready for use. Fig. 20: Installing the sterilisable handle Removing a sterilisable handle from the lighthead 1. Press the locking button. 2. Remove the handle. Fig. 21: Removing the sterilisable handle LUCEA 50-100 32 / 60 IFU 01741 EN 11...

  • Page 33: Manoeuvring The Lighthead

    The lighthead can be manoeuvred in various ways: – For sterile personnel: using the sterile handle provided for this purpose in the centre of the lighthead – For non-sterile personnel: by holding the lighthead directly. LUCEA 50-100 33 / 60 IFU 01741 EN 11...
  • Page 34 Possible rotations of the DF ceiling-mounted light infinite infinite +45° / -50° infinite 180° 320° Fig. 24: Possible rotations of the SF ceiling-mounted light infinite infinite +5° / -75° (LCA50) 180° 320° +10° / -90° (LCA100) LUCEA 50-100 34 / 60 IFU 01741 EN 11...

  • Page 35: Pre-Positioning Examples

    +30° / -80° (LCA50) 180° 320° +10° / -85° (LCA100) 4.4.3 Pre-positioning examples To optimise shadow management, it is advisable to position the lightheads so that they are aligned with the surgeon. LUCEA 50-100 35 / 60 IFU 01741 EN 11...
  • Page 36 The secondary lighthead must also be tilted so as to point to the cavity. It should preferably be controlled so as to direct the light beam at different angles inside the cavity. LUCEA 50-100 36 / 60 IFU 01741 EN 11...

  • Page 37: Remote Control

    Registering the remote control with the second lighthead 1. Proceed in the same way as for the first lighthead. 2. Test that the lighthead selection function on the remote control operates correctly. LUCEA 50-100 37 / 60 IFU 01741 EN 11...

  • Page 38: Changing The Remote Control Batteries

    1. Use a screwdriver to remove the screw that holds the battery cover in place 2. Lift off the cover 3. Remove the batteries 4. Insert the new batteries, paying attention to the polarity 5. Replace the cover and the attachment screw LUCEA 50-100 38 / 60 IFU 01741 EN 11...

  • Page 39: Mobile Light

    3. Lower the lighthead and then move the stand to the desired location 4. Upon reaching the desired location, lock the brakes by pushing down the levers on the casters 5. Plug the power lead into the mains outlet. LUCEA 50-100 39 / 60 IFU 01741 EN 11...

  • Page 40: Battery System Operation

    The light shuts off automatically after the alarm signal sounds (to protect the batteries against deep discharge). If the batteries are fully charged, the LUCEA 50 can run on battery power for at least three hours and the LUCEA 100 for eight hours.

  • Page 41: Battery State

    One of LEDs Operation on bat- (LCA50) or 4 3 to 8 is lit (bat- teries hours (LCA100) tery charge level) Connect the Green Scrolling LEDs Batteries char- power outlet ging Tab. 10: Battery lifetime test LUCEA 50-100 41 / 60 IFU 01741 EN 11...

  • Page 42: Mobile Light Pre-Positioning Example

    Depending on the area of interest, the mobile unit can be installed on the head end or on the foot end of the operating table. • The lighthead is positioned perpendicular to the area of interest. LUCEA 50-100 42 / 60 IFU 01741 EN 11...

  • Page 43: Error Messages And Alarm Indicators

    Error messages and alarm indicators Error messages and alarm indicators Not applicable for this product. LUCEA 50-100 43 / 60 IFU 01741 EN 11...

  • Page 44: Troubleshooting

    Likely cause Corrective action The lighthead does not turn Power cut Contact your facility’s technical services Does not switch over to Contact the Getinge technical backup department Other reason Contact the Getinge technical department The lighthead does not turn Communication problem Contact the Getinge technical off.
  • Page 45 Problem Likely cause Corrective action The mobile light is on, running on the mains supply LED 1 not lit green Electronic fault Contact the Getinge technical department LED 2 lit yellow Mains fuse missing or blown Contact the Getinge technical department LED 1 flashes red...

  • Page 46: Cleaning / Disinfection / Sterilisation

    (soap solution) containing active substances such as detergents and phosphates. Do not use abrasive products, as these could damage the surfaces. 3. Remove the cleaner using a cloth moistened with water and then wipe with a dry cloth. LUCEA 50-100 46 / 60 IFU 01741 EN 11...

  • Page 47: Disinfecting The Device

    ▪ Ethylene diamine tetraacetic acid (2.5%) Tab. 14: 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 50-100 47 / 60 IFU 01741 EN 11...

  • Page 48: Cleaning And Sterilising Stg Hlx Sterilisable Handles

    Typical cleaning cycles in a washer-disinfector The use of non-enzymatic detergents is recommended. Enzymatic detergents may damage the handles. Never soak the handles in these detergents for prolonged periods. Rinse thor- oughly. LUCEA 50-100 48 / 60 IFU 01741 EN 11...

  • Page 49: Sterilisation

    350 uses. Please do not exceed the recommended number of cycles. STG PSX sterilisable handles are not compatible with the LUCEA 50-100. STG HLX sterilisable handles are designed for autoclave sterilisation. 1. Check that the handle is not soiled or cracked.

  • Page 50: 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 51: Technical Specifications

    Radiant energy 3.9 mW/m²/lx ± 0.4 UV illumination ≤ 0.7 W/m² ̶ FSP system ̶ Tab. 18: Table of LUCEA 50-100 optical data Specifications LUCEA 50 LUCEA 100 Tolerance With one mask ± 10 With two masks ± 10 At base of tube 100% ±...
  • Page 52 LED Life Time Certificate Lucea 50 Lucea 100 IES LM-80 Test report for LED According to IES LM-80 standard, lumen maintenance is the remaining luminous flux output (% of the initial output) at a selected operating time. According to IES TM-21 standard, L70(D) is the lumen maintenance life expressed in hours where 70% of initial lumen output is maintained, with D the total duration time for the effective tests, in hours.
  • Page 53 (several short time exposures). The measurements are performed for an illuminance of 130,000 lux for Lucea 100 and 60,000 lux for Lucea 50. The measurements and calculation are performed according to EN 62471. Only the worst values of each set- tings and cupolas are summarized below.

  • Page 54: Electrical Characteristics

    15 hours Fuses 7.5A - 32 240 Vac consumption 0,6 A 100 Vac consumption 1,33 A Tab. 20: LUCEA 50-100 electrical specifications Mechanical specifications 9.3.1 Light Specifications Values Weight, LUCEA 50 mobile without batteries 11 kg Weight, LUCEA 100 mobile without batteries 24 kg Weight, LUCEA 50 mobile with batteries...

  • Page 55: Other Characteristics

    Risk of malfunction of the device The use of the device in an unsuitable environment may affect its operation and performance. Do not use this device except in a professional healthcare facility. LUCEA 50-100 55 / 60 IFU 01741 EN 11...
  • Page 56 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 50-100 56 / 60 IFU 01741 EN 11...
  • Page 57 Immunity to voltage dips and EN 61000-4-11 0% Ut, 10 ms short interruptions (0°; 45°; 90°; 135°; 180°; 225°; 270°; 315°) 0% Ut, 20 ms 70% Ut, 500 ms 0% Ut, 5 s Tab. 24: EMC declaration LUCEA 50-100 57 / 60 IFU 01741 EN 11...
  • Page 58 For full information relating to processing of the device once it is no longer in use, see the LUCEA 50-100 decommissioning instructions (ARD01745). Contact your local Getinge representative to obtain a copy of this document. 10.3...
  • Page 59 Notes...
  • Page 60 *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.

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Lucea 100

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