Getinge Volista Instructions For Use Manual
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Getinge Volista Instructions For Use Manual

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Instructions for use
Volista
IFU 01781 EN 19 2023-06-26

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  • Page 1 Instructions for use Volista IFU 01781 EN 19 2023-06-26...
  • 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. V19 26.06.2023 VOLISTA IFU 01781 EN 19...

  • Page 3: Table Of Contents

    Volista VisioNIR (VSTII only)................19 1.6.3 Accessories..........................19 1.6.3.1 Cameras......................19 1.6.3.2 Handle mount ...................... 21 1.6.3.3 LMD* (on Volista VSTII only)................22 Device identification label ........................Standards applied..........................Information relating to intended use ..................... 1.9.1 Intended use .......................... 27 1.9.2 Indications..........................27 1.9.3...
  • Page 4 From the lighthead or wall-mounted control keypad ........... 46 4.2.3.2 From the touchscreen control panel..............47 4.2.4 AIM (on Volista VSTII only)....................48 4.2.5 Volista VisioNIR* (on Volista VSTII only) ................49 4.2.6 Synchronising the lightheads ....................50 4.2.6.1 From the wall-mounted control keypad ............... 50 4.2.6.2 From the touchscreen control panel..............
  • Page 5 Manual cleaning........................91 6.2.3 Cleaning in a washer-disinfector.................... 91 6.2.4 Sterilisation of the Maquet Sterigrip handles ................. 92 Maintenance ......................93 Visual and functional inspections ......................7.1.1 Monthly inspections ....................... 93 Maintenance schedule.......................... VOLISTA 5 / 106 IFU 01781 EN 19...
  • Page 6 Other characteristics..........................102 EMC declaration ........................... 103 8.7.1 FCC Part 15 (USA only)......................104 Waste management ....................105 Disposal of packaging .......................... 105 Product ..............................105 Electrical and electronic components ....................105 VOLISTA 6 / 106 IFU 01781 EN 19...

  • 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

    High Definition Instructions For Use Ingress Protection rating Light-Emitting Diode Luminance Management Device Near InfraRed Single Fork VCSII Volista Access II VSTII Volista StandOP II White Balance 1.4.2 Symbols used in this manual 1.4.2.1 Cross-references References to other pages of the manual are identified by the “ ” symbol.

  • 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. VOLISTA 9 / 106 IFU 01781 EN 19...

  • Page 10: Light Types

    Volista* range From minimally invasive surgery to general procedures, Getinge offers an extensive and scalable range of Volista products. The range comprises two model series: •...

  • Page 11: Symbols On The Product And Packaging

    Fragile, handle with care DC input Keep away from the rain DC output Temperature range for storage Standby Humidity range for storage Do not discard with conventional Ambient pressure range for storage waste VOLISTA 11 / 106 IFU 01781 EN 19...

  • Page 12: Product Overview

    1 Suspension tube 6 Dual fork 2 Suspension arm 7 VSTII 600 lighthead 3 SF spring arm 8 VSTII 400 lighthead 4 DF spring arm 9 Camera 5 Single fork 10 Sterilisable handle mount VOLISTA 12 / 106 IFU 01781 EN 19...
  • Page 13 Introduction Product overview Fig. 2: Typical configuration: VCSII64DF 1 Suspension tube 5 VCSII 600 lighthead 2 Suspension arm 6 VCSII 400 lighthead 3 Spring arm 7 Camera 4 Fork 8 Sterilisable handle VOLISTA 13 / 106 IFU 01781 EN 19...

  • Page 14: Components

    Light field diameter variation • Green ambient light • AIM mode (on VSTII only) • LMD mode (optional, on VSTII only) • Light field colour variation (optional) • Volista VisioNIR function (optional, on VSTII only) VOLISTA 14 / 106 IFU 01781 EN 19...
  • Page 15 Fig. 4: Boost mode Boost mode (spare lighting capacity) is available on the Volista range and enables the illumina- tion to be set to the maximum level when required by surgical conditions. It ensures that irradi- ance is controlled, in that this mode is deliberately activated, and is not stored when the light is turned off.
  • Page 16 Green It provides minimal lighting for the surgical team and the anaesthetist and creates a soothing atmosphere to welcome patients and minimise their stress. Fig. 7: Ambient light function VOLISTA 16 / 106 IFU 01781 EN 19...

  • Page 17: Options

    Wall-mounted remote control panels Wall-mounted control keypad (on VCSII only) Fig. 8: Available wall-mounted control keypads (on VCSII only) Flush-mounted version Power supply version Surface-mounted version Control keypad Recessed version with front panel VOLISTA 17 / 106 IFU 01781 EN 19...

  • Page 18: Variable Colour Temperature

    The VSTII surgical light features three colour temperatures: 3900 K, 4,500 K and 5,100 K. The VCSII surgical light features three colour temperatures: 3900 K, 4,200 K and 4,500 K. 3 900 K 5 100 K 4 500 K Fig. 10: Colour temperature VOLISTA 18 / 106 IFU 01781 EN 19...

  • Page 19: Volista Visionir (Vstii Only)

    The Volista VisioNIR function is used to filter out the residual near-infrared rays from the LED spectrum in order to keep them at very low levels. Volista VisioNIR is suitable for use with near- field infrared cameras, without disturbing the signal transmitted to the monitor. Volista VisioNIR...
  • Page 20 It ensures operating fluidity by keeping the surgical area clear dur- ing training phases, and facilitates monitoring of surgeons’ actions, enabling their needs to be better anticipated. Fig. 14: OHDII FHD QL AIR03 E/U camera VOLISTA 20 / 106 IFU 01781 EN 19...

  • Page 21: Handle Mount

    The handle mount can be fitted in the centre of the lighthead using the Quick Lock system. It is designed to receive an STG HLX sterilisable handle. Fig. 16: Mount for STG HLX sterilisable handle VOLISTA 21 / 106 IFU 01781 EN 19...

  • Page 22: Lmd* (On Volista Vstii Only)

    Devon® or Deroyal® disposable handle. Fig. 17: Adapter for disposable handle 1.6.3.3 LMD* (on Volista VSTII only) The LMD system (Luminance Management Device) adjusts the illumination perceived by the surgeon’s eye. This innovation is designed to maintain optimal visual acuity and avoid problems relating to vision adjustments in the event of brightness variations.

  • Page 23: Device Identification Label

    CS 10008 Ardon - 45074 Orléans cedex 2 - France YYYY-MM-DD ARDXXXXXXXXX XXXXXX VXXXXXXXXXXXXXXXXXX Volista (XX)XXXXXXXXXXXXXX(XX)XXXXXX(XX)XXXXXX(XXX)ARDXXXXXXXXX(XX)XXXXXXXX AC 100-240 V 50/60 Hz 400 VA AC 24 V 50/60 Hz 400 VA DC 24 V 400 VA ANSI/AAMI ES60601-1 :2005 + AMD (2012) CAN/CSA-C22.2 NO.

  • Page 24: Standards Applied

    (0 Hz – 300 GHz) Ordinance 384/2020 INMETRO Certification - Compliance assessment requirements for equipment under Health Surveil- lance Tab. 3: Compliance with product standards VOLISTA 24 / 106 IFU 01781 EN 19...
  • Page 25 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 Hazardous Substances) Tab. 5: Environmental standards and regulations VOLISTA 25 / 106 IFU 01781 EN 19...
  • Page 26 Health and Human Services Subchapter H -- Medical Devices Tab. 6: Compliance with market standards Other information (for the People's Republic of China only) 产品名称：手术无影灯 规格型号：STANDOP VOLISTA 600, STANDOP VOLISTA 400 SN 序列号：见英文标签 生产日期：见英文标签 使用期限：10 年 注册证号：国械注进 20142015956 产品技术要求编号：国械注进 20142015956 注册人/生产企业名称：Maquet SAS 迈柯唯股份有限公司...

  • Page 27: Information Relating To Intended Use

    The VOLISTA range is designed to illuminate the body of a patient during surgical procedures, diagnostics or treatment. 1.9.2 Indications The VOLISTA range is intended to be used for any type of surgery, treatment or examination re- quiring a specific type of lighting. 1.9.3 Intended users •...

  • Page 28: 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 94]. 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 29: Safety-Related Information

    If the battery discharges too quickly, a lighthead may go out during a procedure. Perform a battery lifetime test monthly to estimate the battery lifetime. Contact 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 30: 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 31: Control Interfaces

    The lighting can also be controlled via an integrator-type external control equip- ment, and the operation of the lighting can be paired with other external equipment (luminous flux, etc.). Contact your Getinge representative for more information. VOLISTA 31 / 106...

  • Page 32: Lighthead Control Keypads

    6 Minus (reduce the level) 2 Illumination adjustment / Ambient light mode 9 Level indicator 3 Light field diameter variation 10 Warning indicator 4 Camera zoom 11 Battery indicator 5 Plus (increase the level) VOLISTA 32 / 106 IFU 01781 EN 19...

  • Page 33: Wall-Mounted Control Keypad (On Vcsii Only)

    12 Battery switchover 5 Light field diameter variation 13 Battery level indicator 6 Camera zoom 14 Battery capacity 7 Plus (increase the level) 15 Warning indicator 8 Level indicator 16 Battery indicator VOLISTA 33 / 106 IFU 01781 EN 19...

  • Page 34: Touchscreen Control Panel

    Area of the screen used to access the menus: home screen, presets, functions and set- tings. Area of the screen used to control the device. Tab. 9: Touchscreen control panel information VOLISTA 34 / 106 IFU 01781 EN 19...
  • Page 35 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 tech- nicians and qualified personnel. Tab. 10: Touchscreen control panel status bar...
  • Page 36 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. 11: Touchscreen control panel status bar VOLISTA 36 / 106 IFU 01781 EN 19...

  • Page 37: Use

    Half-rings on spring arms 1. Check that the half-rings on the spring arms are in place in their slots. 2. If a problem is noted, contact technical support. Fig. 30: Half-rings on spring arms VOLISTA 37 / 106 IFU 01781 EN 19...
  • Page 38 Ø Check that it can be removed easily. 2. Reinstall the handle mount on the light- head. Ø Check that it can be installed smoothly and that the handle mount is properly installed. Fig. 33: Sterilisable handle mount VOLISTA 38 / 106 IFU 01781 EN 19...
  • Page 39 Fig. 35: Integrity of the control keypad Lighthead underside 1. Check that the underside is not damaged (scratches, stains, etc.). 2. If a problem is noted, contact technical support. Fig. 36: Lighthead underside VOLISTA 39 / 106 IFU 01781 EN 19...
  • Page 40 1. Check that the intermediate fork rotates correctly. 2. Check that the intermediate fork does not drift. 3. If a problem is noted, contact technical support. Fig. 39: Integrity of the intermediate fork VOLISTA 40 / 106 IFU 01781 EN 19...
  • Page 41 (on VCSII only) [8 Page 84]) or via the touchscreen con- trol panel (From the touchscreen control panel [8 Page 85]). 2. If the test fails, contact technical support. Fig. 41: Battery backup test VOLISTA 41 / 106 IFU 01781 EN 19...

  • Page 42: Controlling The Light

    2. Press the On/Off button and hold it until the lighthead button turns off. Ø The LED sectors on the lighthead are turned off in sequence once the button is released. VOLISTA 42 / 106 IFU 01781 EN 19...

  • Page 43: From The Touchscreen Control Panel

    2. Press Lighthead ON/OFF Ø Lighthead 1 and the lighthead 1 operation indicator are turned off. 3. Proceed in the same way for all lightheads that are on. Ø The entire light is now off. VOLISTA 43 / 106 IFU 01781 EN 19...

  • 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 colder colour temperature. 3. Press Minus to select a warmer colour temperature. VOLISTA 44 / 106 IFU 01781 EN 19...

  • Page 45: From The Touchscreen Control Panel

    Adjusting the colour temperature 1. From the lighthead page, press to select the choosen colour temperature. Ø The button is lit blue and the selected colour temperature is enabled on the lighthead. VOLISTA 45 / 106 IFU 01781 EN 19...

  • Page 46: Ambient Light

    Ø Ambient lighting is on and the button is backlit on the keypad. 3. Press Plus to increase the light intensity level of the lighthead(s) 4. Press Minus to decrease the light intensity level of the lighthead(s) VOLISTA 46 / 106 IFU 01781 EN 19...

  • Page 47: From The Touchscreen Control Panel

    1. From the lighthead page, press the Standard/ambient light button. Ø When enabled, the button is blue. 2. Press Plus to increase the illumination level of the lighthead(s) 3. Press Minus to decrease the illumination level of the lighthead(s) VOLISTA 47 / 106 IFU 01781 EN 19...

  • Page 48: Aim (On Volista Vstii Only)

    Controlling the light 4.2.4 AIM (on Volista VSTII only) With touchscreen control panel only Fig. 48: AIM page Enabling/disabling AIM mode 1. From the lighthead page, press the AIM mode button. Ø The button is lit blue and AIM mode is enabled on the lighthead(s).

  • Page 49: Volista Visionir* (On Volista Vstii Only)

    Boost function can be used to optimise the settings (see Table 36). The light- heads are then automatically set to the 5100K colour temperature, and the central ring LEDs on the Volista 600 are turned off. The Volista VisioNIR Boost is automatically applied to all the lightheads in the con- figuration. VOLISTA...

  • Page 50: Synchronising The Lightheads

    Ø The lightheads are no longer synchronised. Special case: To synchronise lightheads with ambient light mode, this mode must be active on the lightheads concerned before synchronisation. VOLISTA 50 / 106 IFU 01781 EN 19...

  • Page 51: From The Touchscreen Control Panel

    3. Press Synchronise again to desynchronise the lightheads. Ø The lightheads are desynchronised. Special case: To synchronise lightheads with ambient light mode, this mode must be active on the lightheads concerned before synchronisation. VOLISTA 51 / 106 IFU 01781 EN 19...

  • Page 52: Lmd (Only On Volista Vstii With Touchscreen)

    Controlling the light 4.2.7 LMD (only on Volista VSTII with touchscreen) Fig. 52: LMD page Enabling/disabling LMD mode 1. Set the desired light intensity that is comfortable for the surgeon. 2. Next press LMD Ø The button is lit blue and LMD is enabled on the lighthead(s) concerned; the lightheads are automatically synchronised.

  • Page 53: Presets (With Touchscreen Control Panel Only)

    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. VOLISTA 53 / 106 IFU 01781 EN 19...
  • Page 54 Changes can always be cancelled by pressing Cancel changes Ø A pop-up window is displayed to confirm that the preset has been stored, before returning to the presets page. VOLISTA 54 / 106 IFU 01781 EN 19...

  • Page 55: Factory Presets

    5,100 Small 4,500 Plastic surgery 100% Small 5,100 Cardiac 100% Small 3,900 Tab. 13: Factory default lighthead presets Colour temperature variation is available only on Volista VST. Applications Zoom Contrast Laparotomy Auto High Orthopaedic Auto Medium Plastic surgery Auto Standard Cardiac...

  • Page 56: Positioning The Light

    Ø A click is heard. 3. Rotate the handle until its rotation is locked. Ø The handle is now locked in place and ready for use. Fig. 55: Installing the STG PSX sterilisable handle VOLISTA 56 / 106 IFU 01781 EN 19...

  • Page 57: Installing And Removing The Stg Hlx Sterilisable Handle

    Ø The handle is now locked in place and Fig. 57: 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. 58: Removing the STG HLX sterilisable handle VOLISTA 57 / 106 IFU 01781 EN 19...

  • Page 58: Installing And Removing Devon® Or Deroyal® Handles

    Ø The handle is now ready for use. Fig. 59: Installing a Devon or Deroyal handle Removing a Devon or Deroyal handle from a lighthead 1. Unscrew the handle from the handle mount. Fig. 60: Removing a Devon or Deroyal handle VOLISTA 58 / 106 IFU 01781 EN 19...

  • Page 59: 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. 62: Removing the STG PSX VZ sterilisable handle VOLISTA 59 / 106 IFU 01781 EN 19...

  • Page 60: 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 holding the lighthead directly or the external handle on the fork. VOLISTA 60 / 106 IFU 01781 EN 19...
  • Page 61 360° 250° 330° Fig. 66: Possible rotations of a VSTII60DF single configuration on SATX suspension + 20° 360° 270° - 70° 360° Fig. 67: Possible rotations of a VSTII40SF single configuration on SATX suspension VOLISTA 61 / 106 IFU 01781 EN 19...
  • Page 62 Possible rotations of a VCSII64DF dual configuration on SB suspension 310° 310° + 45° 360° + 45° 360° - 45° 360° 360° - 45° 360° Fig. 69: Possible rotations of a VCSII64SF dual configuration on SB suspension VOLISTA 62 / 106 IFU 01781 EN 19...

  • Page 63: Pre-Positioning Examples

    The suspension arms and spring arms should be located to either side of the table, to avoid cluttering the area above the patient and the surgeon’s head. • The two lights should be located on either side of the surgeon’s shoulders. VOLISTA 63 / 106 IFU 01781 EN 19...
  • Page 64 Plastic surgery Fig. 73: Pre-positioning for plastic surgery For plastic surgery, it is recommended to have two lightheads of the same size so as to ensure that exactly the same lighting is provided symmetrically. VOLISTA 64 / 106 IFU 01781 EN 19...

  • Page 65: Installing Or Removing A Quick Lock Device (Camera, Lmd Or Handle Mount)

    On the Quick Lock camera Fig. 74: 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. VOLISTA 65 / 106 IFU 01781 EN 19...

  • Page 66: On The Lighthead

    Fig. 76: Positioning the lighthead Fig. 77: 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. VOLISTA 66 / 106 IFU 01781 EN 19...

  • Page 67: 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. 80: Removing the lighthead VOLISTA 67 / 106 IFU 01781 EN 19...

  • Page 68: Quick Lock Handle Mount

    2. As with the camera, twist the base of the handle clockwise and then check that the latch has clicked into place. Ø The handle mount is installed. Fig. 82: Presenting the handle VOLISTA 68 / 106 IFU 01781 EN 19...

  • Page 69: 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 69] section.

  • Page 70: Switching On The Registered System

    Adjusting the camera zoom 1. Press Camera Zoom 2. Press Plus or Minus to modify the zoom level. Ø The camera zoom level varies as shown by the level indicator for the selected function VOLISTA 70 / 106 IFU 01781 EN 19...

  • Page 71: From The Touchscreen Control Panel

    1. Press the Camera pause button to pause the camera. Ø The button is lit blue and the transmitted image is frozen. 2. Press the Camera pause button again to resume video transmission. VOLISTA 71 / 106 IFU 01781 EN 19...
  • Page 72 3. Press the Manual balance button twice to set the white balance on the basis of the tar- get under the camera. Ø The selected button is lit blue and the white balance is applied. VOLISTA 72 / 106 IFU 01781 EN 19...
  • Page 73 Contrast adjustment Adjusting the contrast 1. Press the Contrast button to access the contrast adjustment menu. 2. Press the Increase contrast or Decrease contrast buttons to select one of the three contrast levels. VOLISTA 73 / 106 IFU 01781 EN 19...

  • Page 74: Orienting The Camera

    2. Use the handle to rotate the camera. Ø The image is rotated on the screen. Fig. 91: Orienting the camera VOLISTA 74 / 106 IFU 01781 EN 19...

  • Page 75: Settings And Functions

    Ø The Settings page is displayed (see above). 2. Press Date/Time Ø The page for date and time settings and stopwatch/timer functions is displayed. Adjusting the tilt handle (on Volista only) 1. Press Settings in the menu bar. Ø The Settings page is displayed (see above).

  • Page 76: 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. VOLISTA 76 / 106 IFU 01781 EN 19...

  • Page 77: 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. VOLISTA 77 / 106 IFU 01781 EN 19...

  • Page 78: Stopwatch / Timer Function (Only With Touchscreen Control Panel)

    Accessing the stopwatch 1. Press Stopwatch1 in the menu bar. Ø The stopwatch page is displayed. Accessing the timer 1. Press Timer in the menu bar. Ø The timer page is displayed. VOLISTA 78 / 106 IFU 01781 EN 19...

  • Page 79: Stopwatch

    1. Once the stopwatch has been started, press Pause/Activate to temporarily stop the stop- watch. Ø The counter starts flashing. 2. Press Pause/Activate to restart the stopwatch. Ø The counter stops flashing and resumes counting. VOLISTA 79 / 106 IFU 01781 EN 19...

  • Page 80: Timer

    4. After entering the fields, press OK to store the values entered. To cancel changes, press Cancel Ø The timer setting window disappears and the timer is ready to be started with the entered value. VOLISTA 80 / 106 IFU 01781 EN 19...

  • Page 81: Tilt Handle

    Adjusting the illumination using the tilt handle 1. Turn the handle to adjust the light intensity, light field diameter or colour temperature to the chosen setting. The TILT handle does not have limit stops. VOLISTA 81 / 106 IFU 01781 EN 19...

  • Page 82: 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 83: Battery Backup

    Lighthead keypad backup operation indicators Indicators Description Meaning One LED lit red External backup at a very low level (with Getinge backup only) Two LEDs lit red External backup at a low level (with Getinge backup only) Three LEDs lit orange...

  • Page 84: Performing Battery Tests

    If the test fails, the battery level indicator flashes red. 3. If the test fails, contact the Getinge technical service department. 4. Press Switchover test again and hold until the button turns off. Ø The light remains on at Level  3 and the system is ready for use.

  • Page 85: From The Touchscreen Control Panel

    4. If the test fails, press Maintenance information to access the maintenance information page, and then call the Getinge technical service department. Running a battery lifetime test (only with a Getinge backup) 1. Turn off the light. 2. Press Battery Tests in the menu bar.

  • Page 86: Troubleshooting

    Powered from mains Orange indicator Powered from backup supply Flashing red indicator Powered from backup supply (only available with Getinge The batteries are almost totally discharged and the backup) system will lose power in a few minutes. Tab. 20: Battery indicators 5.1.2...

  • Page 87: Potential Failures And Troubleshooting

    The lighthead drifts Suspension tube not vertical Check tube verticality and ceil- ing structure Load-bearing structure un- Contact the Getinge technical stable department Locking screw incorrectly ad- Have the locking screw adjus- justed. ted by a trained technician...
  • Page 88 2. Disconnect and reconnect the receiver power cable 3. Re-register the camera 4. Contact the Getinge tech- nical department Image lost for more than Interference with another sys- 1. The system should reset it- 20 seconds...

  • Page 89: 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. VOLISTA 89 / 106 IFU 01781 EN 19...

  • Page 90: Disinfecting The Device

    ▪ Ethylene diamine tetraacetic acid (2.5%) Tab. 26: Lists of active substances suitable for use Examples of commercially available products tested • ANIOS product®** : Surfa’Safe®** • Other products: 20% or 45% isopropyl alcohol VOLISTA 90 / 106 IFU 01781 EN 19...

  • Page 91: 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. VOLISTA 91 / 106 IFU 01781 EN 19...

  • Page 92: 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. 28: Example of a steam sterilisation cycle VOLISTA 92 / 106 IFU 01781 EN 19...

  • Page 93: 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 94: Maintenance Schedule

    Maintenance Maintenance schedule If the device has a Getinge backup system, perform a battery lifetime test. To test from the wall- mounted control keypad, the lightheads must be turned off and the test start button must be backlit to enable the test to be started. To test from the touchscreen control panel, the battery icon must be displayed in the status bar.

  • Page 95: Technical Specifications

    ±10 With two masks, at base of tube ±10 Tab. 33: 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 VOLISTA...
  • Page 96 50 points, there is no longer any impact on colour discrimination by the surgeon. An increase in R9 is necessarily accompanied by an increase in radiant energy. Irradiance in near-infrared wavelengths of the ranges relevant to fluorescence imaging Volista fixed colour Volista variable col- Volista VisioNIR...

  • Page 97: Optical Specifications For Vcsii Lightheads

    With two masks, at base of tube 50 % 45 % ± 10 Tab. 38: Volista lighthead residual illumination in accordance with the EN 60601-2-41 standard Measured at 4200°K with small light field In nominal mode VOLISTA 97 / 106 IFU 01781 EN 19...

  • Page 98: Electrical Characteristics

    Table of electrical specifications for WPS power supply Electrical compatibility with other devices Compatible electrical devices Compatibility External control device RS232 (only on WPS with RS232 option) External information management Dry contact Tab. 40: Electrical compatibility table VOLISTA 98 / 106 IFU 01781 EN 19...

  • Page 99: Electrical Specifications For Vcsii

    EPS power supply electrical characteristics Electrical compatibility with other devices Compatible electrical devices Compatibility External control device RS232 (WPS with RS232 option only) External information management Dry contact Tab. 43: Electrical compatibility table VOLISTA 99 / 106 IFU 01781 EN 19...

  • Page 100: Mechanical Specifications

    Tab. 46: Mechanical compatibility of the light 8.4.2 Power supply Specifications Volista 600 and 400 Dimensions of WPS wall-mounted unit (H × W × D) 311 × 400 × 145 mm Dimensions of WPS Battery Pack unit (H × W × D) 311 × 400 × 145 mm Weight of WPS Power Supply unit 6.1 kg...

  • Page 101: Video Specifications

    Weight (without sterile handle) 820 g 790 g Dimensions (Ø x h) (without sterile handle) 129 x 167 mm 132 x 198 mm Tab. 49: Electrical specifications of cameras via touch screen only VOLISTA 101 / 106 IFU 01781 EN 19...

  • Page 102: Other Characteristics

    Protection rating for the device as a whole IP 20 Protection rating of the lightheads IP 44 EMDN code Z12010701 GMDN code 12 282 CE marking year 2013 Tab. 52: Specifications relating to standards and regulations VOLISTA 102 / 106 IFU 01781 EN 19...

  • Page 103: Emc Declaration

    Use only accessories and cables supplied or specified by the manufacturer. Electromagnetic interference may result in temporary extinction or temporary flick- ering of the light, which will resume its initial operation once the interference has ceased. VOLISTA 103 / 106 IFU 01781 EN 19...

  • Page 104: Fcc Part 15 (Usa Only)

    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. VOLISTA 104 / 106 IFU 01781 EN 19...

  • Page 105: 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, see the Volista decommissioning instructions (ARD01785). Contact your local Getinge representative to obtain a copy of this document.
  • Page 106 *VOLISTA, Volista VisioNIR, STANDOP, AIM, LMD, FSP, SATELITE, 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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