Getinge Maquet Rolite Instructions For Use Manual
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Getinge Maquet Rolite Instructions For Use Manual

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Instructions for use
Maquet Rolite
IFU 01831 EN 07 2023-07-27

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Summary of Contents for Getinge Maquet Rolite

  • Page 1 Instructions for use Maquet Rolite IFU 01831 EN 07 2023-07-27...
  • 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. V07 27.07.2023 Maquet Rolite IFU 01831 EN 07...

  • Page 3: Table Of Contents

    Inappropriate use ........................28 1.9.4 Contraindications ........................28 1.10 Primary purpose ........................... 1.11 Clinical benefit ............................1.12 Warranty ............................... 1.13 Expected service lifetime ........................1.14 Instructions for reducing the environmental impact ................Maquet Rolite 3 / 108 IFU 01831 EN 07...
  • Page 4 Manoeuvring the lighthead..................... 62 4.3.4 Laser positioning assistance (on Maquet PowerLED II only)..........64 4.3.4.1 From the lighthead control keypad ..............64 4.3.4.2 From the touchscreen control panel..............65 4.3.5 Pre-positioning examples....................... 65 Maquet Rolite 4 / 108 IFU 01831 EN 07...
  • Page 5 Cleaning and sterilising Maquet Sterigrip sterilisable handles ............. 6.2.1 Preparation for cleaning......................92 6.2.2 Manual cleaning........................92 6.2.3 Cleaning in a washer-disinfector.................... 92 6.2.4 Sterilisation of the Maquet Sterigrip handles ................. 93 Maquet Rolite 5 / 108 IFU 01831 EN 07...
  • Page 6 Other characteristics..........................103 EMC declaration ........................... 104 8.6.1 FCC Part 15 (USA only)......................105 Waste management ....................106 Disposal of packaging .......................... 106 Product ..............................106 Electrical and electronic components ....................106 Maquet Rolite 6 / 108 IFU 01831 EN 07...

  • Page 7: Introduction

    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: Information About This Document

    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. Maquet Rolite 8 / 108 IFU 01831 EN 07...

  • Page 9: Menus And Buttons

    • Users are responsible for the safe use of the device and for ensuring that it is used as inten- ded. Maquet Rolite 9 / 108 IFU 01831 EN 07...

  • Page 10: Type Of Light

    Example: A mobile light (Maquet Rolite*) is a minor surgical light. Surgical lighting system Combination of several surgical lights designed to facilitate treatment and diagnosis operations and to be used in operating rooms.

  • Page 11: Symbols On The Product And Packaging

    The lighthead arm must be folded when moving it on sloped surfaces. away before moving the Rolite mo- Turn the light so that the batteries bile light. are towards the bottom of the slope. Maquet Rolite 11 / 108 IFU 01831 EN 07...

  • Page 12: Product Overview

    Introduction Product overview Product overview Fig. 1: Overview of the Maquet Rolite PowerLED II 1 Lighthead 6 Swivel casters 2 Spring arm 7 Batteries 3 Top pole 8 Caster brakes 4 Bottom pole 9 Control interface 5 Stand base Maquet Rolite 12 / 108...
  • Page 13 Comfort Light* Camera with remote control func- tionalities QL+ handle mounts with Tilt QL handle mounts with Tilt Sterilisable handles Power supply cables Tab. 3: Available functions and accessories on the various lightheads Maquet Rolite 13 / 108 IFU 01831 EN 07...

  • Page 14: Components

    Introduction Product overview 1.6.1 Components 1.6.1.1 Lightheads Fig. 2: Available lightheads for Maquet Rolite 1 Maquet PowerLED II 700 lighthead 3 Volista VSTII/VCSII 600 lighthead 2 Maquet PowerLED II 500 lighthead 4 Volista VSTII/VCSII 400 lighthead Maquet Rolite 14 / 108 IFU 01831 EN 07...
  • Page 15 Maquet PowerLED II 700 (small, medium and large) and two settings on the Maquet PowerLED II 500 (small and medium). The Volista lighting system enables the dia- meter to be set to one of five levels. Maquet Rolite 15 / 108 IFU 01831 EN 07...
  • Page 16 It provides the surgical team and the anaesthetist with minimal lighting during minimally invasive procedures. It also creates a calm atmosphere to welcome pa- tients, thereby minimising stress. Maquet Rolite 16 / 108 IFU 01831 EN 07...
  • Page 17 These ions come into contact with bacteria, blocking their metabolism and/or interrupting their multiplication mechanism, resulting in their elimination. ISO 22196:2011 reduction greater than LOG 2 against Staphylococcus aureus and Escheri- chia coli. Maquet Rolite 17 / 108 IFU 01831 EN 07...

  • Page 18: Options

    Colour temperature Fig. 9: Colour temperature 3800 K and 4300 K The Maquet PowerLED II surgical light is available in two colour temperature versions: 3800 K and 4300 K. Maquet Rolite 18 / 108 IFU 01831 EN 07...

  • Page 19: Volista Options

    In this case, the detection area of the fluorescence camera must have a wavelength greater than 740 nm (see Table 35). It is recommended to first test the NIR imaging system and the fluorescent dye with the Volista VisioNIR function in order to optimise the settings. Maquet Rolite 19 / 108 IFU 01831 EN 07...

  • Page 20: Accessories

    The system consists of a USB-powered camera with HDMI output, to which a wire- less system can be interfaced. A camera fitted with a Gefen wireless system is available from Getinge. A different wireless system can also be used instead, fol- lowing approval by Getinge. Please contact a Getinge representative for more in- formation on that option.

  • Page 21: Ql Handle Mounts (Only On Volista)

    The handle mount can be fitted in the centre of the lighthead using the QL system. It is de- signed to receive a STG PSX sterilisable handle. Fig. 16: Mount for STG PSX sterilisable handle Maquet Rolite 21 / 108 IFU 01831 EN 07...

  • Page 22: Lmd (On Maquet Powerled Ii Et Volista Vstii Only)

    Surgeons thus have the same level of illumination when look- ing at dark cavities or light tissue. Fig. 19: LMD module Maquet Rolite 22 / 108 IFU 01831 EN 07...

  • Page 23: Power Supply Cables

    POWER CORD AUS Power cord for Australia 5,686 04,964 POWER CORD ITA Power cord for Italy 5,686 04,962 POWER CORD ARG Power cord for Argentina 5,686 04,968 Tab. 4: Power supply cables Maquet Rolite 23 / 108 IFU 01831 EN 07...

  • Page 24: Device Identification Label

    Parc de Limère-Avenue de la Pomme de Pin CS 10008 Ardon - 45074 Orléans cedex 2 - France YYYY-MM-DD XXXXXX ARDXXXXXXXXX ROL XXXXXXXXXXXXXXXX Maquet Rolite (XX)XXXXXXXXXXXXXX(XX)XXXXXX(XX)XXXXXX(XXX)ARDXXXXXXXXX(XX)XXXXXXXX 100-240Vac ~ 50/60Hz 185VA 24Vac ~ 50/60Hz 185VA 24Vdc 185VA ANSI/AAMI ES60601-1 :2005 + AMD (2012) CAN/CSA-C22.2 NO.

  • Page 25: Standards Applied

    Safety of laser products – Part 1: Equipment classi- EN 60825-1:2014 fication and requirements Ordinance 384/2020 INMETRO Certification - Compliance assessment requirements for equipment under Health Surveil- lance Tab. 5: Compliance with product standards Maquet Rolite 25 / 108 IFU 01831 EN 07...
  • Page 26 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 Hazardous Substances) Tab. 7: Environmental standards and regulations Maquet Rolite 26 / 108 IFU 01831 EN 07...
  • Page 27 PART 7 - Enforcement policy 21CFR Title 21--Food And Drugs Subchapter H Chapter I--Food and Drug Administration Depart- ment of Health and Human Services Subchapter H -- Medical Devices Tab. 8: Compliance with market standards Maquet Rolite 27 / 108 IFU 01831 EN 07...

  • Page 28: Information Relating To Intended Use

    Introduction Information relating to intended use Information relating to intended use 1.9.1 Intended use The Maquet Rolite is designed to illuminate the body of a patient during surgical operations, dia- gnostics or treatment. 1.9.2 Intended users • The device may be operated only by medical staff who have read this manual.

  • Page 29: Expected Service Lifetime

    This 10-year service lifetime applies subject to the annual periodic checks being performed by personnel trained and approved by Getinge. After this time, if the device is still in use, an inspec- tion must be carried out by personnel trained and approved by Getinge to ensure the continued safety of the device.

  • Page 30: Safety-Related Information

    AR NI NG Risk of injury The mobile light may tip over if not handled properly. Push the mobile light to move it. Never pull the light behind you except on a slope. Maquet Rolite 30 / 108 IFU 01831 EN 07...
  • Page 31 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. Maquet Rolite 31 / 108...

  • Page 32: 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 33: Safety Labels On The Product

    Only pull the light behind you when moving it on sloped surfaces. Turn the light so that the batteries are towards the bottom of the slope. Tab. 11: Safety label on the product Maquet Rolite 33 / 108 IFU 01831 EN 07...

  • Page 34: Control Interfaces

    Control interfaces Control interfaces Fig. 23: Control interfaces 1 Lighthead control keypad 2 Touchscreen control panel Maquet Rolite 34 / 108 IFU 01831 EN 07...

  • Page 35: Lighthead Control Keypads

    Adjustment of illumination 11 Ambient light mode Light field diameter variation 12 Laser positioning mode* Camera zoom (not operational on 13 Laser safety symbol PowerLED II) 14 Colour temperature variation Plus (increase the level) Maquet Rolite 35 / 108 IFU 01831 EN 07...

  • Page 36: Touchscreen Control Panel

    Active area Menu bar No. Description Area of the screen used to display the fault indicator, battery indicator, time, Getinge logo and customer logo. Area of the screen used to access the menus: home screen, presets, functions and set- tings.
  • Page 37 Press the clock icon to access the date and time settings. Getinge logo ▪ Press the Getinge logo to access product maintenance information. ▪ Press the Getinge logo a second time to access a menu reserved for Getinge technicians and qualified personnel, see Groups of people. Tab. 13:...
  • Page 38 Battery tests Press the Battery Tests icon to access the backup tests page. Return Press the return button to return to the previous screen. Tab. 14: Touchscreen control panel status bar Maquet Rolite 38 / 108 IFU 01831 EN 07...

  • Page 39: Use

    Half-rings on spring arms 1. Check that the half-rings on the spring arm are in place in their slot. 2. If a problem is noted, contact technical support. Fig. 29: Inspection of spring arm half-rings Maquet Rolite 39 / 108 IFU 01831 EN 07...
  • Page 40 Lighthead gaskets 1. Check that the lighthead gaskets are in the proper position and in good condition. 2. If a problem is noted, contact technical support. Fig. 32: Inspection of lighthead gaskets Maquet Rolite 40 / 108 IFU 01831 EN 07...
  • Page 41 3. Turn on the light, selecting the largest light field diameter (such that all LEDs are lit); see Adjusting the illumination [8 Page 44]. 4. Check that all the LEDs are operating. Fig. 35: Operation of LEDs Maquet Rolite 41 / 108 IFU 01831 EN 07...

  • Page 42: Controlling The Light

    Turning the light on and off 4.2.1.1 Turning on the mobile light 1. Press the On/Off button on the mobile light to turn on the device. Fig. 38: Turning on the light Maquet Rolite 42 / 108 IFU 01831 EN 07...

  • Page 43: From The Lighthead Control Keypad

    1. Press the Lighthead active area Ø The lighthead control page is displayed. 2. Press Lighthead ON/OFF Ø The lighthead and the operation indicator are turned off. Ø The light is now off. Maquet Rolite 43 / 108 IFU 01831 EN 07...

  • Page 44: Adjusting The Illumination

    Adjusting the colour temperature 1. Press Colour Temperature Ø The button is backlit on the keypad. 2. Press Plus to select a warmer colour temperature. 3. Press Minus to select a colder colour temperature. Maquet Rolite 44 / 108 IFU 01831 EN 07...

  • Page 45: From The Touchscreen Control Panel

    1. From the lighthead page, press 3900K , 4500K or 5100K to select the desired col- our temperature. Ø The button is lit blue and the selected colour temperature is enabled on the lighthead. Maquet Rolite 45 / 108 IFU 01831 EN 07...

  • Page 46: Ambient Light

    1. Press Ambient light mode Ø The button is backlit on the keypad. 2. Press Plus to increase the illumination level of the lighthead 3. Press Minus to decrease the illumination level of the lighthead Maquet Rolite 46 / 108 IFU 01831 EN 07...

  • Page 47: From The Touchscreen Control Panel

    Ø When enabled, the button is blue. 2. Press Plus to increase the light intensity level of the lighthead 3. Press Minus to decrease the light intensity level of the lighthead Maquet Rolite 47 / 108 IFU 01831 EN 07...

  • Page 48: Aim

    2. When AIM mode is enabled, press Minus to decrease the light intensity level of the light- head. Boost mode is not available when AIM mode is enabled. In this case, the light has 10 illumination levels. Maquet Rolite 48 / 108 IFU 01831 EN 07...

  • Page 49: From The Touchscreen Control Panel

    Adjusting the light field diameter with AIM 1. Press Increase diameter to increase the light field diameter of the lighthead. 2. Press Decrease diameter to decrease the light field diameter of the lighthead. Maquet Rolite 49 / 108 IFU 01831 EN 07...

  • Page 50: Volista Visionir* (On Vstii Only)

    Boost function can be used to optimise the settings (see Table 35). The light- heads are then automatically set to the 5100K colour temperature, and the central ring LEDs on the Volista 600 are turned off. Maquet Rolite 50 / 108 IFU 01831 EN 07...

  • Page 51: Comfort Light* (Option Available On Maquet Powerled Ii Only)

    Ø The button is lit blue and the Comfort Light is enabled on the lighthead. 2. When the Comfort Light is enabled, press Comfort Light to disable it. Ø The button turns off and the Comfort Light is disabled on the lighthead. Maquet Rolite 51 / 108 IFU 01831 EN 07...

  • Page 52: Lmd* (On Maquet Powerled Ii Et Volista Vstii Only)

    If the lighthead is at its maximum level, the luminance cannot be increased and the Minus button is shaded and inactive. The luminance level indicator provides a visual indication that the stored luminance level is maintained: Maquet Rolite 52 / 108 IFU 01831 EN 07...

  • Page 53: Presets

    Presets page. Ø The presets page is displayed. 2. Press the Apply preset button for the desired preset name corresponding to of the six saved presets. Ø The selected preset is applied. Maquet Rolite 53 / 108 IFU 01831 EN 07...

  • Page 54: Factory Presets

    ̶ Auto laser ̶ ̶ ̶ ̶ ̶ ̶ Comfort Enabled Enabled Enabled Enabled Enabled Enabled Light Endo ̶ ̶ ̶ ̶ ̶ ̶ Tab. 16: Maquet PowerLED II factory default lighthead presets Maquet Rolite 54 / 108 IFU 01831 EN 07...
  • Page 55 Volista factory default lighthead presets Applications Zoom Contrast Laparotomy Auto High Orthopaedic Auto Medium Plastic surgery 20 % Auto Standard Cardiac Auto High Tab. 19: Factory default camera presets (only on Volista) Maquet Rolite 55 / 108 IFU 01831 EN 07...

  • Page 56: Positioning The Light

    Position the light by following the steps set out, to ensure that it is properly stable. AR NI NG Risk of injury The mobile light may tip over if a person leans on it. Never lean on the mobile light. Maquet Rolite 56 / 108 IFU 01831 EN 07...
  • Page 57 6. After moving the light to its new location, lock it in place by pushing down on the brake pedals on the rear casters Maquet Rolite 57 / 108 IFU 01831 EN 07...

  • Page 58: Fitting The Sterilisable Handle

    Fig. 53: Installing the STG PSX sterilisable handle Removing the sterilisable handle from a lighthead 1. Press the locking button. 2. Remove the handle. Fig. 54: Removing the STG PSX sterilisable handle Maquet Rolite 58 / 108 IFU 01831 EN 07...

  • Page 59: Installing And Removing A Stg Hlx Sterilisable Handle On The Lighthead

    Fig. 55: Installing the STG HLX sterilisable handle ready for use. Removing the sterilisable handle from a lighthead 1. Press the locking button. 2. Remove the handle. Fig. 56: Removing the STG HLX sterilisable handle Maquet Rolite 59 / 108 IFU 01831 EN 07...

  • Page 60: Installing And Removing Devon® Or Deroyal® Handles

    Fig. 57: Installing a Devon or Deroyal handle Removing a Devon or Deroyal handle from a lighthead 1. Unscrew the handle from the handle mount. Fig. 58: Removing a Devon or Deroyal handle Maquet Rolite 60 / 108 IFU 01831 EN 07...

  • Page 61: Installing And Removing The Stg Psx Vz Sterilisable Handle

    Installing the STG PSX VZ sterilisable handle Removing a sterilisable handle for use with a camera from a lighthead 1. Press the locking button. 2. Remove the handle. Fig. 60: Removing the STG PSX VZ sterilisable handle Maquet Rolite 61 / 108 IFU 01831 EN 07...

  • Page 62: Manoeuvring The Lighthead

    – For sterile personnel: using the sterile handle provided for this purpose in the centre of the lighthead – For non-sterile personnel: by handling the lighthead either directly or using its outer handle Maquet Rolite 62 / 108 IFU 01831 EN 07...
  • Page 63 +45° / -45° (Volista VCSII) 330° (Volista) Tab. 20: Maquet Rolite rotation angles Overall height of lighting system 890 mm 2405 mm 860 mm Fig. 63: Overall height of Maquet Rolite lighting system Maquet Rolite 63 / 108 IFU 01831 EN 07...

  • Page 64: Laser Positioning Assistance (On Maquet Powerled Ii Only)

    Ø The lighthead is then at the optimum distance from the area to be illuminated. 3. Press the Laser button again to turn off the laser manually before the 20 seconds have elapsed. Maquet Rolite 64 / 108 IFU 01831 EN 07...

  • Page 65: From The Touchscreen Control Panel

    3. Position the lighthead so as to bring the two dots closer together. Ø The lighthead is then at the optimum distance from the area to be illuminated. 4.3.5 Pre-positioning examples Fig. 67: Maquet Rolite pre-positioning Maquet Rolite 65 / 108 IFU 01831 EN 07...

  • Page 66: Storing The Mobile Light

    The estimated battery charging time is approximately 14 hours. The batteries will discharge when the product is stored. Connect the device to the mains supply regularly to charge the batteries, and check the battery level before use. Maquet Rolite 66 / 108 IFU 01831 EN 07...

  • Page 67: Installing/Removing A Ql+ Device

    2. Rotate the accessory until it clicks 3. Move the lighthead to check that the QL+ device is firmly attached. Ø The QL+ device is installed. Fig. 70: Installing a QL+ device Maquet Rolite 67 / 108 IFU 01831 EN 07...

  • Page 68: Removing The Device

    2. Once the lighthead is turned over, rotate the locking interface anti-clockwise and then remove the Quick Lock device whilst holding the locking interface Ø The Quick Lock device is removed. Fig. 71: Removing a Quick Lock device Maquet Rolite 68 / 108 IFU 01831 EN 07...

  • Page 69: Installing/Removing A Ql Device

    On camera and LMD QL Fig. 72: Pre-positioning the Quick Lock camera 1. Rotate the baseplate to align with the tip and form a green arrow Ø The camera is ready to be positioned. Maquet Rolite 69 / 108 IFU 01831 EN 07...

  • Page 70: On The Lighthead

    Fig. 74: Positioning the lighthead Fig. 75: Instructions for installing the Quick Lock system 1. Present the camera with the pin opposite the slot 2. Place the two arrows opposite each other. Maquet Rolite 70 / 108 IFU 01831 EN 07...

  • Page 71: Removing The Device

    2. Keep the button pressed and, using two hands, rotate the base of the device anticlockwise. 3. Remove the Quick Lock camera by pulling upwards Ø The device is removed. Fig. 78: Removing the lighthead Maquet Rolite 71 / 108 IFU 01831 EN 07...

  • Page 72: Quick Lock Handle Mount

    2. As for the camera, rotate the base of the handle clockwise and then check that the lock is correctly engaged. Ø The handle mount is installed. Fig. 80: Presenting the handle Maquet Rolite 72 / 108 IFU 01831 EN 07...

  • Page 73: Using The Camera

    The OHDII AIR03 QL FHD camera with wireless system requires a pairing step during the first use, and an intermediate procedural step during subsequent uses. Getinge offers a camera version pre-fitted with a GEFEN® wireless transmission key; refer to the instructions supplied with the wireless system or see the Wireless video system [8 Page 73] section.

  • Page 74: Switching On The Registered System

    “Source already listed” is displayed, and then wait for 30 seconds for the image to appear. The receiver can store up to eight transmitters. If the memory is full, use the “Remove transmitter” function in the Setup menu. Maquet Rolite 74 / 108 IFU 01831 EN 07...

  • Page 75: Controlling The Camera

    Turning the camera on via the lighthead page 1. From the lighthead page, press the Camera shortcut Ø The camera page is displayed and the camera is turned on. Maquet Rolite 75 / 108 IFU 01831 EN 07...
  • Page 76 Zooming in and out 1. Press Zoom to access the zoom adjustment menu. 2. Press Zoom in or Zoom out to adjust the size of the image on screen in real time. Maquet Rolite 76 / 108 IFU 01831 EN 07...
  • Page 77 Setting the focus Setting the focus automatically 1. Press Focus to access the focus adjustment menu. 2. Press Auto Focus Ø The button is lit blue and the camera focus is automatic. Maquet Rolite 77 / 108 IFU 01831 EN 07...

  • Page 78: Orienting The Camera

    2. Use the handle to rotate the camera. Ø The image is rotated on the screen. Fig. 91: Orienting the camera Maquet Rolite 78 / 108 IFU 01831 EN 07...

  • Page 79: Settings And Functions

    Ø The tilt handle adjustment page is displayed. Accessing configuration information 1. Press Settings in the menu bar. Ø The Settings page is displayed (see above). 2. Press Information Ø The configuration information page is displayed. Maquet Rolite 79 / 108 IFU 01831 EN 07...

  • Page 80: Screen Brightness

    Ø The screen brightness varies as shown by the brightness level indicator 2. Press OK to confirm the brightness changes, or Cancel to cancel the changes in pro- gress. Ø The configured brightness is stored and applied. Maquet Rolite 80 / 108 IFU 01831 EN 07...

  • Page 81: Date And Time, And Stopwatch/Timer Functions

    Ø The selected field is shown with a blue border. 3. Use the keypad to enter the desired value and then press OK to confirm the changes. Ø The data entry window closes and the changes take effect. Maquet Rolite 81 / 108 IFU 01831 EN 07...

  • Page 82: Tilt Handle

    4. Press Disabled so that the Tilt handle is disabled and does not adjust any lighting para- meters. Fig. 96: TILT handles Maquet Rolite 82 / 108 IFU 01831 EN 07...

  • Page 83: Information

    Press Maintenance to display the dates on which maintenance was performed and the Getinge contact details. Press Power supply to display a history of power cuts. Press Battery Backup to display a history of battery backup tests.

  • Page 84: Backup Battery

    Lighthead keypad backup operation indicators Indicators Description Meaning Full orange battery Backup power supply on Non-full orange battery Remaining battery lifetime Flashing red indicator Cut-out imminent Tab. 23: Backup operation indicators on the touchscreen control panel Maquet Rolite 84 / 108 IFU 01831 EN 07...

  • Page 85: Performing The Battery Test

    If the test fails, however, a red cross and a Maintenance Information button are displayed. 4. If the test fails, press Maintenance information to access the maintenance information page, and then call the Getinge technical service department. Maquet Rolite 85 / 108 IFU 01831 EN 07...
  • Page 86 Backup battery Running a battery lifetime test (only with a Getinge backup) 1. Turn off the light. 2. Press Battery Tests in the menu bar. Ø The battery tests page is displayed. 3. Press Battery lifetime test to start the test.

  • Page 87: Troubleshooting

    Battery charge indicator System charging Tab. 26: Battery indicators Indicator Description Meaning ̶ Indicator off No fault Warning indicator Faulty system Tab. 27: Warning indicators Maquet Rolite 87 / 108 IFU 01831 EN 07...

  • Page 88: Potential Failures And Troubleshooting

    The sterilisable handle does The locking mechanism is Replace the handle not click into place correctly damaged Device too stiff to manoeuvre Mechanical lock Contact the Getinge technical department Tab. 29: Mechanical anomalies and malfunctions Electronics/Optics Anomaly Likely cause Corrective action...
  • Page 89 Fault type (e.g. Communication failure, Option failure, etc.) Faulty element (e.g. Power 2, Backup, etc.) Example error message on the touchscreen control panel: Volista 600 1: Option failure (Backup) In all cases, please contact Getinge technical support. Maquet Rolite 89 / 108...

  • Page 90: 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. Maquet Rolite 90 / 108 IFU 01831 EN 07...

  • Page 91: Disinfecting The Device

    ▪ Ethylene diamine tetraacetic acid (2.5%) Tab. 31: Lists of active substances suitable for use Examples of commercially available products tested • ANIOS product®** : Surfa’Safe®** • Other products: 20% or 45% isopropyl alcohol Maquet Rolite 91 / 108 IFU 01831 EN 07...

  • Page 92: Cleaning And Sterilising Maquet Sterigrip 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. Maquet Rolite 92 / 108 IFU 01831 EN 07...

  • Page 93: Sterilisation Of The Maquet Sterigrip Handles

    4. Run the sterilisation cycle according to the steriliser manufacturer’s instructions. Sterilisation cycle Temperature Time (°C) (min) (min) ATNC (Prion) ̶ Prevacuum Tab. 33: Example of a steam sterilisation cycle Maquet Rolite 93 / 108 IFU 01831 EN 07...

  • Page 94: 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 95: Technical Specifications

    ̶ Tab. 35: Table of optical data for Maquet PowerLED II 700 and Maquet PowerLED II 500 lightheads For all light field diameters In nominal mode The colour temperature is selected at the time of order Maquet Rolite 95 / 108 IFU 01831 EN 07...
  • Page 96 Specifications in AIM mode Laser specifications Values Wavelength 650 nm Beam divergence 0.58 mrad Maximum power output 1 mW Tab. 38: Laser specifications Optical values measured with the largest light field diameter Maquet Rolite 96 / 108 IFU 01831 EN 07...

  • Page 97: Optical Properties Of Vstii Lightheads

    ±10 Tab. 40: Volista lighthead residual illumination in accordance with the EN 60601-2-41 standard Measured with small light field and fixed colour temperature Measured at 4500ºK with variable colour temperature In nominal mode Maquet Rolite 97 / 108 IFU 01831 EN 07...
  • Page 98 ≤ 35 W/m² ≤ 12 W/m² ≤ 1.25 W/m² 710-800 nm range Irradiance in the ≤ 2.1 W/m² ≤ 0.25 W/m² ≤ 0.03 W/m² 800-870 nm range Tab. 43: Irradiance in near-infrared wavelengths Maquet Rolite 98 / 108 IFU 01831 EN 07...

  • Page 99: Optical Specifications For Vcsii Lightheads

    With two masks, at base of tube 50 % 45 % ± 10 Tab. 45: Volista lighthead residual illumination in accordance with the EN 60601-2-41 standard Measured at 4200°K with small light field In nominal mode Maquet Rolite 99 / 108 IFU 01831 EN 07...

  • Page 100: Electrical Characteristics

    Average service life of LEDs 60,000 hours per TM-81:2012 standard 55,000 hours per TM-81:2016 standard Battery charge time 14 hours Battery pack capacity 8 hours minimum Battery type Lead gel Tab. 47: Volista VSTII lighthead power consumption Maquet Rolite 100 / 108 IFU 01831 EN 07...

  • Page 101: Volista Vcsii

    VCSII light mechanical specifications For Volista VSTII Specifications Volista VSTII 600 Volista VSTII 400 Weight of single-fork lighthead 14 kg 13 kg Lighthead diameter 700 mm 630 mm Tab. 51: VSTII light mechanical specifications Maquet Rolite 101 / 108 IFU 01831 EN 07...

  • Page 102: Technical Specifications Of The Camera And Receiver

    Transmission type Wireless RS232 interface Weight (without sterile handle) 790 g Dimensions (diam. x h) (without sterile handle) 132 x 198 mm Tab. 52: Technical specifications of the camera via touch screen only Maquet Rolite 102 / 108 IFU 01831 EN 07...

  • Page 103: Other Characteristics

    Class II Protection rating for the device as a whole IP 20 Protection rating of the lightheads IP 44 EMDN code Z12010702 GMDN code 36843 Tab. 54: Specifications relating to standards and regulations Maquet Rolite 103 / 108 IFU 01831 EN 07...

  • Page 104: Emc Declaration

    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. Maquet Rolite 104 / 108 IFU 01831 EN 07...

  • Page 105: 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. Maquet Rolite 105 / 108 IFU 01831 EN 07...

  • Page 106: 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. Do not dispose of contaminated sterilisable handles as municipal waste. 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 107 Notes...
  • Page 108 *MAQUET ROLITE, POWERLED II, VOLISTA, VOLISTA VISIONIR, AIM, COMFORT LIGHT, LASER POSITIONING, FSP, POWERLED, ROLITE, MAQUET, GETINGE and GETINGE GROUP are trademarks or registered trademarks of Getinge AB, its divisions or its subsidiaries. **DEVON is a trademark or registered trademark of Covidien LP, its divisions or its subsidi- aries.

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