Getinge Volista User manual

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

Copyright
All rights reserved. This document may not be copied, adapted or translated without prior written permission,
except as permitted under copyright law.
© Copyright 2021 Maquet SAS
Subject to technical changes.
The illustrations and technical specifications provided in this manual may, on account of future product devel-
opments, differ slightly from the actual product supplied.
V19 26.06.2023
VOLISTA
IFU 01781 EN 19

Contents
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Contents
1 Introduction .............................................................................................................. 7
1.1 Preface ................................................................................................................................................. 7
1.2 Liability.................................................................................................................................................. 7
1.3 Other documents relating to this product.............................................................................................. 7
1.4 Information about this document .......................................................................................................... 8
1.4.1 Abbreviations ......................................................................................................................... 8
1.4.2 Symbols used in this manual ................................................................................................. 8
1.4.2.1 Cross-references................................................................................................. 8
1.4.2.2 Reference numbers............................................................................................. 8
1.4.2.3 Actions and results .............................................................................................. 8
1.4.2.4 Menus and buttons.............................................................................................. 9
1.4.2.5 Hazard levels....................................................................................................... 9
1.4.2.6 Indications ........................................................................................................... 9
1.4.3 Definitions .............................................................................................................................. 9
1.4.3.1 Groups of people................................................................................................. 9
1.4.3.2 Light types ........................................................................................................... 10
1.5 Symbols on the product and packaging ............................................................................................... 11
1.6 Product overview .................................................................................................................................. 12
1.6.1 Components........................................................................................................................... 14
1.6.1.1 Lightheads........................................................................................................... 14
1.6.2 Options................................................................................................................................... 17
1.6.2.1 Wall-mounted remote control panels................................................................... 17
1.6.2.2 Variable colour temperature ................................................................................ 18
1.6.2.3 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
1.7 Device identification label .................................................................................................................... 23
1.8 Standards applied................................................................................................................................. 24
1.9 Information relating to intended use ..................................................................................................... 27
1.9.1 Intended use .......................................................................................................................... 27
1.9.2 Indications.............................................................................................................................. 27
1.9.3 Intended users ....................................................................................................................... 27
1.9.4 Inappropriate use ................................................................................................................... 27
1.9.5 Contraindications ................................................................................................................... 27
1.10 Primary purpose ................................................................................................................................... 27
1.11 Clinical benefit ...................................................................................................................................... 27
1.12 Warranty ............................................................................................................................................... 27
1.13 Expected service lifetime...................................................................................................................... 28
1.14 Instructions for reducing the environmental impact .............................................................................. 28

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2 Safety-related information....................................................................................... 29
2.1 Environmental conditions ..................................................................................................................... 29
2.2 Safety instructions ................................................................................................................................ 29
2.2.1 Safe use of the product.......................................................................................................... 29
2.2.2 Electrical ................................................................................................................................ 30
2.2.3 Optical.................................................................................................................................... 30
2.2.4 Infection ................................................................................................................................. 30
3 Control interfaces .................................................................................................... 31
3.1 Lighthead control keypads.................................................................................................................... 32
3.2 Wall-mounted control keypad (on VCSII only)...................................................................................... 33
3.3 Touchscreen control panel ................................................................................................................... 34
4 Use............................................................................................................................. 37
4.1 Daily inspections................................................................................................................................... 37
4.2 Controlling the light............................................................................................................................... 42
4.2.1 Turning the light on and off .................................................................................................... 42
4.2.1.1 From the lighthead or wall-mounted control keypad ........................................... 42
4.2.1.2 From the touchscreen control panel.................................................................... 43
4.2.2 Adjusting the illumination ....................................................................................................... 44
4.2.2.1 From the lighthead or wall-mounted control keypad ........................................... 44
4.2.2.2 From the touchscreen control panel.................................................................... 45
4.2.3 Ambient light .......................................................................................................................... 46
4.2.3.1 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.................................................................... 51
4.2.7 LMD (only on Volista VSTII with touchscreen)....................................................................... 52
4.2.8 Presets (with touchscreen control panel only) ....................................................................... 53
4.2.8.1 Selecting or storing a preset................................................................................ 53
4.2.8.2 Factory presets.................................................................................................... 55
4.3 Positioning the light .............................................................................................................................. 56
4.3.1 Fitting the sterilisable handle ................................................................................................. 56
4.3.1.1 Installing and removing the STG PSX sterilisable handle ................................... 56
4.3.1.2 Installing and removing the STG HLX sterilisable handle ................................... 57
4.3.1.3 Installing and removing DEVON® or DEROYAL® handles ................................ 58
4.3.1.4 Installing and removing the STGPSXVZ sterilisable handle ............................. 59
4.3.2 Manoeuvring the lighthead..................................................................................................... 60
4.3.3 Pre-positioning examples....................................................................................................... 63
4.4 Installing or removing a Quick Lock device (camera, LMD or handle mount) ...................................... 65
4.4.1 Pre-positioning the device...................................................................................................... 65
4.4.1.1 On the Quick Lock camera.................................................................................. 65
4.4.1.2 On the lighthead .................................................................................................. 66

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4.4.2 Fitting the device to the lighthead .......................................................................................... 66
4.4.3 Removing the device ............................................................................................................. 67
4.4.4 Quick Lock handle mount ...................................................................................................... 68
4.5 Using the camera ................................................................................................................................. 69
4.5.1 Wireless video system ........................................................................................................... 69
4.5.1.1 Registering the camera ....................................................................................... 69
4.5.1.2 Switching on the registered system..................................................................... 70
4.5.2 Controlling the camera........................................................................................................... 70
4.5.2.1 From the lighthead or wall-mounted control keypad (zoom only)........................ 70
4.5.2.2 From the touchscreen control panel.................................................................... 71
4.5.3 Orienting the camera ............................................................................................................. 74
4.6 Settings and functions .......................................................................................................................... 75
4.6.1 Screen brightness .................................................................................................................. 76
4.6.2 Date and time, and stopwatch/timer functions ....................................................................... 77
4.6.3 Stopwatch / Timer function (only with touchscreen control panel)......................................... 78
4.6.3.1 Stopwatch............................................................................................................ 79
4.6.3.2 Timer ................................................................................................................... 80
4.6.4 Tilt handle .............................................................................................................................. 81
4.6.5 Information ............................................................................................................................. 82
4.7 Battery backup...................................................................................................................................... 83
4.7.1 LEDs ...................................................................................................................................... 83
4.7.2 Performing battery tests......................................................................................................... 84
4.7.2.1 From the wall-mounted control keypad (on VCSII only)...................................... 84
4.7.2.2 From the touchscreen control panel.................................................................... 85
5 Troubleshooting....................................................................................................... 86
5.1 Warning indicators................................................................................................................................ 86
5.1.1 Indicators on the lighthead and wall-mounted control keypads ............................................. 86
5.1.2 Indicators shown on the touchscreen control panel............................................................... 86
5.2 Potential failures and troubleshooting .................................................................................................. 87
6 Cleaning / Disinfection / Sterilisation..................................................................... 89
6.1 Cleaning and disinfecting the system ................................................................................................... 89
6.1.1 Cleaning the device ............................................................................................................... 89
6.1.2 Disinfecting the device ........................................................................................................... 90
6.1.2.1 Disinfectants to be used ...................................................................................... 90
6.1.2.2 Permitted active substances ............................................................................... 90
6.2 Cleaning and sterilising Maquet Sterigrip sterilisable handles ............................................................. 91
6.2.1 Preparation for cleaning......................................................................................................... 91
6.2.2 Manual cleaning..................................................................................................................... 91
6.2.3 Cleaning in a washer-disinfector............................................................................................ 91
6.2.4 Sterilisation of the Maquet Sterigrip handles ......................................................................... 92
7 Maintenance ............................................................................................................. 93
7.1 Visual and functional inspections ......................................................................................................... 93
7.1.1 Monthly inspections ............................................................................................................... 93
7.2 Maintenance schedule.......................................................................................................................... 94

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7.3 Contact ................................................................................................................................................. 94
8 Technical specifications.......................................................................................... 95
8.1 Optical properties of VSTII lightheads .................................................................................................. 95
8.2 Optical specifications for VCSII lightheads........................................................................................... 97
8.3 Electrical characteristics ....................................................................................................................... 98
8.3.1 VSTII electrical specifications ................................................................................................ 98
8.3.2 Electrical specifications for VCSII .......................................................................................... 99
8.4 Mechanical specifications..................................................................................................................... 100
8.4.1 Light ....................................................................................................................................... 100
8.4.2 Power supply ......................................................................................................................... 100
8.5 Video specifications.............................................................................................................................. 101
8.5.1 Electrical specifications of cameras and receivers ................................................................ 101
8.6 Other characteristics............................................................................................................................. 102
8.7 EMC declaration ................................................................................................................................... 103
8.7.1 FCC Part 15 (USA only)......................................................................................................... 104
9 Waste management ................................................................................................. 105
9.1 Disposal of packaging .......................................................................................................................... 105
9.2 Product ................................................................................................................................................. 105
9.3 Electrical and electronic components ................................................................................................... 105

Introduction
Preface 1
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1 Introduction
1.1 Preface
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. Getinge
provides solutions that respond to the safety, efficiency and economic constraints faced by hos-
pitals.
Building on its experience in surgical lights, ceiling-mounted equipment management systems
and multimedia solutions, Getinge focuses on quality and innovation to ensure that its solutions
best meet the needs of patients and healthcare staff. Getinge surgical lights are world-renowned
for their design and innovative features.
1.2 Liability
Modifications to the product
The product must not be modified in any way without the prior written consent of Getinge.
Compliant use of the device
Getinge may not be held liable for any direct or indirect damage that results from actions not set
out in this user’s manual.
Installation and maintenance
Installation, maintenance and decommissioning operations must be performed by trained person-
nel, approved by Getinge.
Training on the device
Training must be provided directly on the device by personnel approved by Getinge.
Compatibility with other medical devices
Only medical devices approved in accordance with IEC 60601-1 or UL 60601-1 should be in-
stalled on the system.
The compatibility data is detailed in the chapter entitled Technical specifications [8Page95].
The compatible accessories are detailed in the chapter concerned.
In the event of an incident
Any serious incident occurring in connection with the device must be notified to the manufacturer
and the relevant authority of the member state in which the user and/or patient is based.
1.3 Other documents relating to this product
• Volista Installation Recommendations (Ref.ARD01786)
• Volista Installation Instructions (Ref.ARD01784)
• Volista Maintenance Instructions (Ref.ARD01780)
• Volista Repair Instructions (Ref.ARD01782)
• Volista Decommissioning Instructions (Ref.ARD01785)

1Introduction
Information about this document
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1.4 Information about this document
This user’s manual is intended for day-to-day users of the product, staff supervisors and hospital
authorities. It is intended to familiarise users with the design, safety features and operation of the
product. The manual is organised and divided into several separate chapters.
Please note:
• Please read the user's manual thoroughly and in full before using the product for the first
time.
• Always proceed in line with the instructions in the user’s manual.
• Keep this manual close to the equipment.
1.4.1 Abbreviations
AIM Automatic Illumination Management
EMC Electromagnetic compatibility
DF Double Fork
FSP* Flux Stability Program
HD High Definition
IFU Instructions For Use
IP Ingress Protection rating
LED Light-Emitting Diode
LMD Luminance Management Device
NIR Near InfraRed
SF Single Fork
VCSII Volista Access II
VSTII Volista StandOP II
WB 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.
1.4.2.2 Reference numbers
Reference numbers in illustrations and text are shown in a square box 1.
1.4.2.3 Actions and results
Actions to be performed by the user are listed with sequence numbers; the “ ” symbol is used to
show the result of an action.
Example:
Prerequisites:
• The sterilisable handle must be compatible with the product.
1. Fit the handle to the mount.
ØA click is heard.
2. Turn the handle until it locks into place with a second click.

Introduction
Information about this document 1
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1.4.2.4 Menus and buttons
Menu and button names are shown in bold.
Example:
1. Press the Save button.
ØThe changes are saved and the Favourites menu is displayed.
1.4.2.5 Hazard levels
The text in safety instructions describes types of risk and how to avoid them. Safety instructions
are classified into the following three levels:
Symbol Hazard level Meaning
DANGER! Indicates a direct and immediate risk that may be
fatal or cause very serious injuries potentially lead-
ing to death.
WARNING! Indicates a potential risk that may cause injuries,
health hazards or serious material damage leading
to injuries.
CAUTION! Indicates a potential risk that may cause material
damage.
Tab.1: Hazard levels of safety instructions
1.4.2.6 Indications
Symbol Indication type Meaning
NOTICE 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
1.4.3 Definitions
1.4.3.1 Groups of people
Users
• Users are persons who are authorised to use the device, either by virtue of their qualifications
or as a result of receiving training from a qualified person.
• Users are responsible for the safe use of the device and for ensuring that it is used as inten-
ded.

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Information about this document
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Qualified personnel:
• Qualified personnel are persons who have acquired knowledge through specialised training
in medical technology or due to their professional experience and knowledge of the safety
rules relating to the tasks performed.
• In countries where certification is required to exercise a medico-technical profession, person-
nel must hold the necessary authorisation in order to be considered as qualified.
1.4.3.2 Light types
Minor surgical light
Single light located in the patient’s environment in an operating room and designed to facilitate
treatment and diagnosis procedures which can be interrupted without compromising patient
safety in the event of a light failure.
Surgical lighting system
Combination of several surgical lights designed to facilitate treatment and diagnosis operations
and to be used in operating rooms. A surgical lighting system must be failsafe and must provide
adequate central illumination to light the body of the patient locally even if an initial fault condition
occurs.
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:
• Volista VCSII series (Volista Access 2nd generation)
• Volista VSTII series (Volista StandOP 2nd generation)

Introduction
Symbols on the product and packaging 1
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1.5 Symbols on the product and packaging
Follow the instructions for use
(IEC60601-1:2012)
Medical Device (MD) marking
Follow the instructions for use
(IEC60601-1:2005).
Unique device identification
Follow the instructions for use
(IEC60601-1:1996).
CE marking (Europe)
Manufacturer + manufacturing date UL mark (Canada and United States)
Product code UR mark (Canada and United
States)
Product serial number Packaging orientation
AC input 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
waste
Ambient pressure range for storage

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1.6 Product overview
1
2
34
5
6
7
8
9
10
Fig.1: Typical configuration: VSTII64SFDF
1 Suspension tube
2 Suspension arm
3 SF spring arm
4 DF spring arm
5 Single fork
6 Dual fork
7 VSTII 600 lighthead
8 VSTII 400 lighthead
9 Camera
10 Sterilisable handle mount

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1
2
3
4
5
6
7
8
Fig.2: Typical configuration: VCSII64DF
1 Suspension tube
2 Suspension arm
3 Spring arm
4 Fork
5 VCSII 600 lighthead
6 VCSII 400 lighthead
7 Camera
8 Sterilisable handle

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1.6.1 Components
1.6.1.1 Lightheads
Fig.3: Volista600 & Volista400 lightheads
Each lighthead comprises the following components:
• Handle mount and sterilisable handle
• Lighthead control keypad
• External handle
Each lighthead includes the following functions:
• Boost mode
• 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)

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Boost mode
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. When activated, the last bar on the illumination level indicator on the lighthead flashes,
drawing the user’s attention to the possibility of excessive irradiance when the light fields are su-
perimposed.
Light field diameter variation
Fig.5: Light field diameter variation
The light field diameter variation function can
be used to adjust the size of the illuminated
area to match the dimensions of the incision.
The Volista lighting system enables the dia-
meter to be set to one of five levels.

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AIM* mode (on VSTII only)
Fig.6: Presence of one or two surgeons
This function automatically compensates for the loss of illumination due to the presence of
obstacles (surgeons’ head or shoulders) between the lighthead and the surgical site. Illumination
is reduced in the obstructed LEDs and increased in the unobstructed LEDs to ensure that:
• Illumination is stable at the surgical site
• The surgeon’s movements are unrestricted
• The surgeon’s working conditions are improved
Ambient light
Green
Fig.7: Ambient light function
Ambient lighting is designed to enhance con-
trast to enable easier viewing of monitor
screens during minimally invasive procedures.
It provides minimal lighting for the surgical
team and the anaesthetist and creates a
soothing atmosphere to welcome patients and
minimise their stress.

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1.6.2 Options
1.6.2.1 Wall-mounted remote control panels
Wall-mounted control keypad (on VCSII only)
123
4
5
Fig.8: Available wall-mounted control keypads (on VCSII only)
1 Flush-mounted version
2 Surface-mounted version
3 Recessed version with front panel
4 Power supply version
5 Control keypad

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Touchscreen control panel
12
3
4
Fig.9: Touchscreen control panels available
1 Flush-mounted version
2 Surface-mounted version
3 Power supply version
4 Touchscreen control panel
1.6.2.2 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.
5 100 K
4 500 K
3 900 K
Fig.10: Colour temperature

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1.6.2.3 Volista VisioNIR (VSTII only)
Fig.11: Volista VisioNIR function
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
can be used during surgery using ICG (indocyanine green), as well as by taking advantage of the
natural property of certain tissues, which emit fluorescent light following stimulation (autofluores-
cence). In this case, the detection area of the fluorescence camera must have a wavelength
greater than 740nm (see Table35).
NOTE
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.
1.6.3 Accessories
1.6.3.1 Cameras
Fig.12: Volista with camera
The camera can be mounted in the centre of
the lighthead using the Quick Lock system.

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NOTE
Use only one camera per configuration.
Wired camera: OHDII FHD QL VP01 (on VSTII only)
Fig.13: OHDII FHD QL VP01 camera
This camera features a quick lock system en-
abling it to be moved from one operating
theatre to another, and offers genuine benefits
for the surgical team. 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. It can be installed only
on a lighthead that is pre-wired for video.
NOTE
Before installing a wired camera, make sure the lighthead is pre-wired for video by
checking the label on the lighthead. The label must bear the indication "VP". If the
camera is installed on a lighthead that is not pre-wired for video, the camera will be
detected, but no viewing of the video will be possible.
Camera with remote control functionalities: OHDII FHD QL AIR03 E/U
Fig.14: OHDII FHD QL AIR03 E/U camera
This camera features a quick lock system en-
abling it to be moved from one operating
theatre to another, and offers genuine benefits
for the surgical team. 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.