Getinge Maquet Rolite User manual

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

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.
V07 27.07.2023
Maquet Rolite
IFU 01831 EN 07

Contents
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IFU 01831 EN 07 3 / 108
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 Type of light......................................................................................................... 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................................................................................................................................... 18
1.6.2.1 Maquet PowerLED II options............................................................................... 18
1.6.2.2 Volista options ..................................................................................................... 19
1.6.3 Accessories............................................................................................................................ 20
1.6.3.1 Camera with wireless system OHDII FHD QL AIR03/E/U (only on Volista light-
heads) ................................................................................................................. 20
1.6.3.2 QL+ handle mounts (only on MaquetPowerLEDII)............................................ 20
1.6.3.3 QL handle mounts (only on Volista) .................................................................... 21
1.6.3.4 LMD (on Maquet PowerLED II et Volista VSTII only).......................................... 22
1.6.3.5 Power supply cables ........................................................................................... 23
1.7 Device identification label ..................................................................................................................... 24
1.8 Standards applied................................................................................................................................. 25
1.9 Information relating to intended use ..................................................................................................... 28
1.9.1 Intended use .......................................................................................................................... 28
1.9.2 Intended users ....................................................................................................................... 28
1.9.3 Inappropriate use ................................................................................................................... 28
1.9.4 Contraindications ................................................................................................................... 28
1.10 Primary purpose ................................................................................................................................... 28
1.11 Clinical benefit ...................................................................................................................................... 28
1.12 Warranty ............................................................................................................................................... 28
1.13 Expected service lifetime...................................................................................................................... 29
1.14 Instructions for reducing the environmental impact .............................................................................. 29

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IFU 01831 EN 07
2 Safety-related information....................................................................................... 30
2.1 Environmental conditions ..................................................................................................................... 30
2.2 Safety instructions ................................................................................................................................ 30
2.2.1 Safe use of the product.......................................................................................................... 30
2.2.2 Electrical ................................................................................................................................ 32
2.2.3 Optical.................................................................................................................................... 32
2.2.4 Infection ................................................................................................................................. 32
2.3 Safety labels on the product ................................................................................................................. 33
3 Control interfaces .................................................................................................... 34
3.1 Lighthead control keypads.................................................................................................................... 35
3.2 Touchscreen control panel ................................................................................................................... 36
4 Use............................................................................................................................. 39
4.1 Daily inspections before use................................................................................................................. 39
4.2 Controlling the light............................................................................................................................... 42
4.2.1 Turning the light on and off .................................................................................................... 42
4.2.1.1 Turning on the mobile light .................................................................................. 42
4.2.1.2 From the lighthead control keypad ...................................................................... 43
4.2.1.3 From the touchscreen control panel.................................................................... 43
4.2.2 Adjusting the illumination ....................................................................................................... 44
4.2.2.1 From the lighthead 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 control keypad ...................................................................... 46
4.2.3.2 From the touchscreen control panel.................................................................... 47
4.2.4 AIM......................................................................................................................................... 48
4.2.4.1 From the lighthead control keypad (only with Maquet PowerLEDII) .................. 48
4.2.4.2 From the touchscreen control panel.................................................................... 49
4.2.5 Volista VisioNIR* (on VSTII only)........................................................................................... 50
4.2.6 Comfort Light* (option available on Maquet PowerLEDII only)............................................. 51
4.2.7 LMD* (on Maquet PowerLED II et Volista VSTII only) ........................................................... 52
4.2.8 Presets................................................................................................................................... 53
4.2.8.1 Selecting or storing a preset................................................................................ 53
4.2.8.2 Factory presets.................................................................................................... 54
4.3 Positioning the light .............................................................................................................................. 56
4.3.1 Moving the mobile light .......................................................................................................... 56
4.3.2 Fitting the sterilisable handle ................................................................................................. 58
4.3.2.1 Installing and removing a STGPSX sterilisable handle on the lighthead ........... 58
4.3.2.2 Installing and removing a STGHLX sterilisable handle on the lighthead............ 59
4.3.2.3 Installing and removing DEVON® or DEROYAL® handles®**........................... 60
4.3.2.4 Installing and removing the STGPSXVZ sterilisable handle ............................. 61
4.3.3 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

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4.3.6 Storing the mobile light .......................................................................................................... 66
4.4 Installing/removing a QL+ device ......................................................................................................... 67
4.4.1 Fitting the device to the Maquet PowerLEDII lighthead ........................................................ 67
4.4.2 Removing the device ............................................................................................................. 68
4.5 Installing/removing a QL device ........................................................................................................... 69
4.5.1 Pre-positioning the device...................................................................................................... 69
4.5.1.1 On camera and LMD QL ..................................................................................... 69
4.5.1.2 On the lighthead .................................................................................................. 70
4.5.2 Fitting the device to the lighthead .......................................................................................... 70
4.5.3 Removing the device ............................................................................................................. 71
4.5.4 Quick Lock handle mount ...................................................................................................... 72
4.6 Using the camera ................................................................................................................................. 73
4.6.1 Wireless video system ........................................................................................................... 73
4.6.1.1 Commissioning and registration .......................................................................... 73
4.6.1.2 Switching on the registered system..................................................................... 74
4.6.2 Controlling the camera........................................................................................................... 75
4.6.2.1 From the lighthead control keypad ...................................................................... 75
4.6.2.2 From the touchscreen control panel.................................................................... 75
4.6.3 Orienting the camera ............................................................................................................. 78
4.7 Settings and functions .......................................................................................................................... 79
4.7.1 Screen brightness .................................................................................................................. 80
4.7.2 Date and time, and stopwatch/timer functions ....................................................................... 81
4.7.3 TILT handle............................................................................................................................ 82
4.7.4 Information ............................................................................................................................. 83
4.8 Backup battery...................................................................................................................................... 84
4.8.1 LEDs ...................................................................................................................................... 84
4.8.2 Performing the battery test..................................................................................................... 85
4.8.2.1 From the touchscreen control panel.................................................................... 85
5 Troubleshooting....................................................................................................... 87
5.1 Warning indicators................................................................................................................................ 87
5.1.1 Indicators on the lighthead control keypads........................................................................... 87
5.1.2 Indicators shown on the touchscreen control panel............................................................... 87
5.2 Potential failures and troubleshooting .................................................................................................. 88
6 Cleaning / Disinfection / Sterilisation..................................................................... 90
6.1 Cleaning and disinfecting the system ................................................................................................... 90
6.1.1 Cleaning the device ............................................................................................................... 90
6.1.2 Disinfecting the device ........................................................................................................... 91
6.1.2.1 Disinfectants to be used ...................................................................................... 91
6.1.2.2 Permitted active substances ............................................................................... 91
6.2 Cleaning and sterilising Maquet Sterigrip sterilisable handles ............................................................. 92
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

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7 Maintenance ............................................................................................................. 94
7.1 Maintenance schedule.......................................................................................................................... 94
7.2 Contact ................................................................................................................................................. 94
8 Technical specifications.......................................................................................... 95
8.1 Optical specifications............................................................................................................................ 95
8.1.1 Optical specifications for Maquet PowerLEDII lightheads .................................................... 95
8.1.2 Optical properties of VSTII lightheads ................................................................................... 97
8.1.3 Optical specifications for VCSII lightheads ............................................................................ 99
8.2 Electrical characteristics ....................................................................................................................... 100
8.2.1 Maquet PowerLED II.............................................................................................................. 100
8.2.2 Volista VSTII .......................................................................................................................... 100
8.2.3 Volista VCSII.......................................................................................................................... 101
8.3 Mechanical specifications..................................................................................................................... 101
8.3.1 Maquet PowerLED II.............................................................................................................. 101
8.3.2 Volista .................................................................................................................................... 101
8.4 Technical specifications of the camera and receiver............................................................................ 102
8.5 Other characteristics............................................................................................................................. 103
8.6 EMC declaration ................................................................................................................................... 104
8.6.1 FCC Part 15 (USA only)......................................................................................................... 105
9 Waste management ................................................................................................. 106
9.1 Disposal of packaging .......................................................................................................................... 106
9.2 Product ................................................................................................................................................. 106
9.3 Electrical and electronic components ................................................................................................... 106

Introduction
Preface 1
Maquet Rolite
IFU 01831 EN 07 7 / 108
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
• Repair manual (Ref. ARD01832)
• Maintenance manual (Ref. ARD01833)
• Installation manual (Ref. ARD01834)

1Introduction
Information about this document
8 / 108 Maquet Rolite
IFU 01831 EN 07
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
FSP* Flux Stability Program
HD High Definition
IFU Instructions For Use
K Kelvin
LED Light-Emitting Diode
LMD Luminance Management Device
lx lux
N/A Not Applicable
QL(+) Quick Lock(+)
SF Single Fork
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
Maquet Rolite
IFU 01831 EN 07 9 / 108
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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IFU 01831 EN 07
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 Type of light
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.
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. 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.
Example: Two mobile lights or one mobile light used in conjunction with another minor surgical
light (ceiling-mounted surgical light or single wall-mounted light) form a surgical lighting system.

Introduction
Symbols on the product and packaging 1
Maquet Rolite
IFU 01831 EN 07 11 / 108
1.5 Symbols on the product and packaging
Follow the instructions for use
(IEC60601-1:2012).
CE marking (Europe)
Follow the instructions for use
(IEC60601-1:2005).
UL mark (Canada and United States)
Follow the instructions for use
(IEC60601-1:1996).
Do not discard with conventional
waste
Manufacturer + manufacturing date Medical Device (MD) marking
Product code Unique device identification
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
Laser radiation. Ambient pressure range for storage
Equipotential grounding connector Swivel legs locked into position for
use
Caution: Non-insulated live parts in-
side the device.
Risk of toppling: Do not push the mo-
bile light or lean on it when the
casters are locked.
Place yourself on the lighthead side
when moving the light on sloped sur-
faces. 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.
Push the Rolite mobile light to move
it. Do not pull the light behind you.
The lighthead arm must be folded
away before moving the Rolite mo-
bile light.

1Introduction
Product overview
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IFU 01831 EN 07
1.6 Product overview
1
23
4
5
6
7
8
9
Fig.1: Overview of the Maquet Rolite PowerLEDII
1 Lighthead
2 Spring arm
3 Top pole
4 Bottom pole
5 Stand base
6 Swivel casters
7 Batteries
8 Caster brakes
9 Control interface

Introduction
Product overview 1
Maquet Rolite
IFU 01831 EN 07 13 / 108
Functions Volista VCSII Volista VSTII Maquet PWDII
Boost mode
Light field diameter variation
Ambient light
AIM mode
Laser positioning system
Antimicrobial film for lighthead
control keypad
Colour temperature selected at
time of order
Variable colour temperature
Volista VisioNIR
Comfort Light*
Camera with remote control func-
tionalities
QL+ handle mounts with Tilt
QL handle mounts with Tilt
Sterilisable handles
LMD
Power supply cables
Tab.3: Available functions and accessories on the various lightheads

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IFU 01831 EN 07
1.6.1 Components
1.6.1.1 Lightheads
1
2
34
Fig.2: Available lightheads for Maquet Rolite
1 Maquet PowerLEDII 700 lighthead
2 Maquet PowerLEDII 500 lighthead
3 Volista VSTII/VCSII 600 lighthead
4 Volista VSTII/VCSII 400 lighthead

Introduction
Product overview 1
Maquet Rolite
IFU 01831 EN 07 15 / 108
Boost mode
Fig.3: Boost mode
Boost mode (spare lighting capacity) enables the illumination to be set to the maximum level
when required by surgical conditions. Boosting the illumination level is unnecessary under normal
conditions; this mode is activated only when required.
Light field diameter variation
1 2 3
Fig.4: Light field diameter variation
1 Maquet PowerLEDII700
2 Maquet PowerLEDII500
3 Volista VSTII VCSII 400 + 600
The light field diameter variation function can be used to adjust the size of the light field so that it
matches the dimensions of the incision. The Maquet PowerLEDII lighting system provides three
diameter settings on the 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.

1Introduction
Product overview
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IFU 01831 EN 07
AIM mode (on Maquet PowerLED II and Volista VSTII only)
Fig.5: 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
Fig.6: Ambient light
Multi-coloured ambient lighting enhances contrast to enable easier viewing of monitors during
minimally invasive procedures. 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.

Introduction
Product overview 1
Maquet Rolite
IFU 01831 EN 07 17 / 108
Laser positioning assistance function (on Maquet PowerLEDII only)
Fig.7: Laser positioning assistance on Maquet PowerLEDII
This function enables the surgical light to be ideally positioned relative to the incision. Surgeons
can then work under optimum conditions, with maximum illumination of the area of interest.
WARNING!
Risk of injury
Prolonged exposure to laser light may result in eye damage.
Do not direct a laser beam into the patient’s unprotected eyes. Users must
not look directly into the laser beam.
Antimicrobial film on the lighthead control keypad (on Maquet PowerLEDII only)
PVC film and paint containing silver ions are incorporated on the most used areas of the light-
heads (keyboards, external handle) to ensure antibacterial1 efficacy between two cleaning opera-
tions. Silver ions may be released during cleaning operations or in the presence of humidity.
These ions come into contact with bacteria, blocking their metabolism and/or interrupting their
multiplication mechanism, resulting in their elimination.
1ISO 22196:2011 reduction greater than LOG 2 against Staphylococcus aureus and Escheri-
chia coli.

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Product overview
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IFU 01831 EN 07
1.6.2 Options
1.6.2.1 Maquet PowerLED II options
Comfort Light*
Without Comfort Light With Comfort Light
Fig.8: Comfort light
This function forms a low-intensity light field around the main surgical site. The reduced contrast
resulting from this additional peripheral lighting enhances the comfort and visual performance of
the surgical team, in particular by reducing perceived glare.
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.

Introduction
Product overview 1
Maquet Rolite
IFU 01831 EN 07 19 / 108
1.6.2.2 Volista options
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
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.

1Introduction
Product overview
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IFU 01831 EN 07
1.6.3 Accessories
1.6.3.1 Camera with wireless system OHDII FHD QL AIR03/E/U (only on Volista lightheads)
Fig.12: OHDII FHD QL AIR03E/U camera
This camera features a QL system enabling 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 sur-
gical area clear during training phases, and facilitates monitoring of surgeons’ actions, enabling
their needs to be better anticipated.
NOTE
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.
1.6.3.2 QL+ handle mounts (only on MaquetPowerLEDII)
Fig.13: Mount for STGPSX sterilisable handle
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.