Acteon PSPIX User manual

User Manual
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2PSPIX² • User manual
TABLE OF CONTENTS
FOREWORD....................................................................................................3
PRESENTATION OF THE PSPIX SYSTEM ....................................................................4
SAFETY INFORMATION .......................................................................................9
REGULATORY STATEMENT ................................................................................. 12
CONFIGURATION OF THE PSPIX SYSTEM................................................................. 18
INSTALLATION AND SETTINGS............................................................................. 20
USE ........................................................................................................... 24
IMAGING PLATE (IP)........................................................................................ 36
MAINTENANCE .............................................................................................. 40
AFTER SALES SERVICE..................................................................................... 48
TECHNICAL SPECIFICATIONS .............................................................................. 51
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FOREWORD
Congratulations and thank you for buying ACTEON’s PSPIX system.
In order to obtain the best results, please read the information presented in this user manual carefully.
Always be aware of those messages marked as “WARNING”, “CAUTION” and “NOTE” when using the PSPIX.
WARNING: WARNING identifies potential incidents that can occur through the use of the PSPIX system.
CAUTION: CAUTION refers to any incident likely to either impact the correct operation of the imaging
system or cause injury.
NOTE: NOTE emphasizes specific points of importance for system maintenance or information clarification.
NOTE :
Correct use and handling of the device is outlined within the user manual. The user is entirely responsible
for any damage that may result from improper use.
REWO
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PRESENTATION OF THE PSPIX SYSTEM
2.1. DESCRIPTION
NOTE:
These instructions concern a system that comprises of two medical devices: the PSPIX system and
radioluminescent imaging plates. We also present the accessories associated with these two medical
devices.
The PSPIX system is a laser X-ray device designed to digitize, display and erase imaging plates (IPs) - also
known as phosphor plates.
The PSPIX system operates with a computer (PC or Mac) running dental imaging software. It can be directly
connected to a computer or the network with an Ethernet cable. The PSPIX system can be configured to
operate with a single computer for a single user or several computers in a multi-user configuration. The
multi-user configuration allows the PSPIX system to be connected to up to ten computers, each workstation
using the PSPIX system successively.
The dental X-ray image is obtained by exposing the IP to X-rays, this is achieved by placing the IP’s behind
the dental area of the patient to be X-rayed. The IP is then inserted into the PSPIX system for reading.
The information from the IP is displayed simultaneously as an X-ray image on both the PSPIX screen and
the connected computer through the PSPIX acquisition module.. This image is then interpreted by the
practioner/dentist.
The PSPIX system has been designed to offer optimal quality and workflow. The available features, simplifies
use by making it possible to interact with the PSPIX system..
Through its reduced size and its futuristic design, the PSPIX system will fit perfectly into any dental practice.
CAUTION:
Federal Laws restrict these devices to the sale or on order to a dentist.
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2.2 SYSTEM COMPONENTS
The PSPIX system includes the following items.
- the IP reader, known as the PSPIX
- Two Size-1 IPs
- Two Size-2 IPs
- One start-up kit of 100 hygiene bags and protective covers for each size of the IP’s supplied.
This protection is in the form of a protective cover in a hygiene bag.
- A box of 10 samples of SOPROWIPE IP cleaning wipes.
- A microfiber cloth.
- 8 SOPROTABS samples, which are soft pads to support an IP in the mouth.
- A storage box for IPs
- A stylus for the PSPIX screen
- An Ethernet Cable
- An external 100 – 240 V~50/60 Hz FRIWO FW7362M/12 adapter
- A Quick Start
- A CD-ROM to install the PSPIX acquisition module
Optional:
- Size-0 and Size-3 IPs
- Box of hygiene bags and protective covers for Size-0 and Size-3 IPs
- A Size-4 starter kit with two Size-3 IPs, a plastic support and hygiene bags.
- Autoclavable and removable parts: insert for IP and receptacle for IP.
CAUTION:
Risk of contamination and/or malfunction of the PSPIX system. The PSPIX system and its accessories have
been designed to optimize the safety and performance of the product. Use of accessories other than
those originally supplied can result in a risk to the patient, the user or the equipment. Do not use IPs,
protective covers, or hygiene bags supplied by other manufacturers.
NOTE:
The PSPIX system has been delivered in a cardboard package to ensure maximum protection of the
equipment. This package should be kept for any subsequent shipping.
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2.3 PRINCIPLE OF OPERATION
The PSPIX system is only intended for the optical reading and processing of IP images. The PSPIX system
converts the image data stored on the IP into a digital image. This image is then transfered by an acquisition
module and displayed on the screen by dental imaging software, and is finally viewed and interpreted by
the practitioner.
Stage 1: Acquiring a X-ray image
• The IP is slid into a single-use cover integrated in a hygiene bag, which is also single-use.
• The protected IP is now placed in the patient’s mouth behind the part of the mouth to be X-rayed.
• After exposure, the protected IP is removed from the patient’s mouth and then disinfected with a
disinfectant cloth. The user can then remove his/her gloves and clean his/her hands.
• The cardboard protective cover along with the IP contained inside are taken out of the plastic hygiene
bag by the user.
Stage 2: Reading the image data
• Once the PSPIX system is ready to use, the IP (with it’s protective cover still attached) must be correctly
inserted into the IP slot (1) of the PSPIX system.
• The IP is then detected by the PSPIX system and is automatically logged by the system to be read.
• The protective cover remains in place in the IP slot (1). Once empty, it can be removed and discarded.
• The IP then arrives in the PSPIX system reading module where the images are read with the aid of a laser.
The IP’s are then collected, processed and transferred to the connected computer via an acquisition module.
An animation indicates the progress of the IP reading.
• After several seconds the digital image will appear simultaneously on the Touch screen of the PSPIX (2) and
on the computer screen through the dental imaging software.
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Stage 3: Deleting the image data
• After reading, the IP passes through the delete module, where the image data is deleted.
• It then falls into the IP receptacle (3) of the PSPIX system and can be directly used for a new X-ray image.
• The PSPIX system is now ready to read the next IP.
Stage 4: Additional X-rays
• If the IPs are not reused immediately they must be stored in the storage box, kept away from exposure
to ambient light.
The IPs must not be exposed to sunlight, UV rays or X-rays outside their period of acquisition.
When used correctly the IPs are reusable hundreds or even thousands of times. Before every new use it
is important to check that the IP is not scratched or damaged. Never use IPs that are damaged, creased,
modified and/or discolored.
2.4 MAIN COMPONENTS
IP insertion slot (1)
IP insertion slot (1)
IP insertion part (4)
Touch screen (2)
IP receptacle (3)
Front
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Plug for
Power Supply
Cable Plug for Ethernet cable
Identification Plate
Back
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SAFETY INFORMATION
3.1. GENERAL SAFETY INFORMATION
WARNING:
This medical device is designed to be used on patients (persons) that are fit to have a dental X-ray.
- The devise is intended to be used in an aseptic environment within a dental practice, dental clinic
or hospital examination room by a qualified dentist in order to avoid any risk of contamination and/or
malfunction of the PSPIX system.
- The PSPIX system must not be used in the presence of flammable anesthetics, pure oxygen or nitrous
oxide to avoid any risk of explosion.
- The PSPIX system is a category 1 laser product. Once the top is lifted the PSPIX system becomes a
category 3B laser product. Ensure you do not expose your eyes to the laser beam, to avoid risk of
damage. .
Any commands, adjustments or interventions other than those specified within this manual can possibly
result in exposure to dangerous laser radiation and can cause damage to the eyes.
- Only specialist, trained technicians approved by ACTEON are authorized to install the equipment and
carry out maintenance and/or repairs in order to avoid any risk of electrocution and/or malfunction of
the PSPIX system. The PSPIX system does not comprise of any components that are repairable by the user.
- The PSPIX system and its accessories particularly the IP’s, the protective covers and the hygiene
bags, have been designed and developed to guarantee maximum safety and performance. The use of
accessories other than those originally supplied can cause risk to the patient, the user or the equipment.
Do not use IPs, protective covers, or hygiene bags supplied by other manufacturers, in order to avoid any
risk of contamination or malfunction of the PSPIX.
- The PSPIX system and its accessories must not be modified, transformed or refurbished, in order to
avoid any risk contamination and/or malfunction of the PSPIX system.
- Do not swallow the IPs! Risk of poisoning
- Always observe the necessary health precautions when handling the IP, the covers and hygiene bags,
in order to avoid any risk of cross-contamination
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- Always comply with anti-contamination and sterilization measures when using accessories such as
positioning holders, the generator and IPs. It is essential to follow the user instructions supplied by the
manufacturer in order to avoid any risk of cross-contamination.
- Do not drop the PSPIX system. After dropping the device do not reconnect the PSPIX system, but send
it to your approved distributor or to the SOPRO Service Department in order to avoid any damage to
eyes and/or any malfunction of the PSPIX system.
- The PSPIX system meets standard IEC 60601-1. Only peripherals that meet standard IEC 60950-1 may
be connected to the PSPIX system in order to avoid any malfunction of the PSPIX system.
CAUTION:
- To ensure safe use and correct operation of the PSPIX system, it is essential to use the power supply
provided with the PSPIX system. The power supply provided with the PSPIX system must only be re-
placed with the same model: FRIWO FW7362M/12 100 – 240 V~ 50/60 Hz 700 mA, in order to avoid any
risk of electrocution and/or malfunction of the appliance.
- Use of the PSPIX system may, due to its EMC characteristics, affect or cause a malfunction of other
appliances in the vicinity.
- The use of other devices may interfere with the PSPIX system, due to their EMC characteristics. This
can may cause a PSPIX system malfunction.
- The reading of IPs and the transfer of the image from the PSPIX system to a computer may be sensi-
tive to electromagnetic disturbance, this can also cause a disturbance to the computer network. A
stable Ethernet network must be maintained at the dental practice or clinic, in order to avoid any
malfunction of the PSPIX system.
- Do not move or bang the PSPIX system when it is processing the image, in order to avoid any risk of
the system malfunction.
WARNING :
You will find other safety information in all the chapters of this user manual. Please read this entire
user manual.
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3.2. OPERATING SYSTEM ENVIRONMENT
Please refer to chapter 5 “System Configuration”.
3.3. ENVIRONMENTAL CONDITIONS FOR STORING AND/OR TRANSPORTING THE PSPIX SYSTEM.
Please refer to chapter 11 “Technical Specifications”.
3.4. PRECAUTIONS TO BE TAKEN WITH THE ETHERNET CONNECTION
For Ethernet port connections, use the CAT5 (RJ45) cable provided. It can be directly connected to a
computer or a local area network. This must be standardized according to the standards EN60950 or
IEC60950 or UL 60950.
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REGULATORY STATEMENT
4.1. COMPLIANCE WITH STANDARDS AND REGULATIONS
The PSPIX system has been designed and manufactured by SOPRO, a company which is certified with
the ISO13485 Quality Control System Standard. It complies with the essential requirements of European
Directive 93/42/EEC concerning medical devices. It therefore particularly complies with the IEC standards
on electrical safety and Electromagnetic Compatibility (EMC).
4.2. ELECTROMAGNETIC INTERFACES AND ELECTROSTATIC DISCHARGES
Electromagnetic compatibility (EMC) covers the ability of the components of electronic appliances to
correctly interact in an electronic environment. Although the PSPIX system has been designed with this
compatibility and respects the thresholds of electromagnetic interferences put in place by the regulatory
body, no guarantee is given regarding the interferences likely to be produced at a given facility. If the PSPIX
system generates interference with radio communication services (which can be checked by switching it on
and then switching it off again) we advise that you avoid this by taking all or some of the following steps:
• Change the position of the receiving antenna
• Reposition the PSPIX system in relation to the receiver.
• Keep the computer at a good distance from the receiver.
The PSPIX system is designed and tested to be used in a domestic class B and group 1 environment in
compliance with standard CISPR11.
CAUTION:
The internal components of the PSPIX system may be sensitive to electrostatic discharges once the IP
insertion part has been removed. Do not insert any metallic object or any source likely to cause an
electrostatic discharge into the device.This can cause a PSPIX system malfunction.
4.3. MONITORING SYSTEMS FOR MEDICAL DEVICES
As with any medical device, the PSPIX system is equipped with monitoring systems for medical devices. Any
serious malfunction must be reported both to the competent authorities and to the manufacturer as soon as
and with as much detail as possible.
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4.4. END OF LIFESPAN
The PSPIX system is recyclable in accordance with European Directive 2002/96/EC on the disposal of electric
and electronic waste (DEEE or WEEE).
By correctly disposing of the PSPIX system, you help to avoid deterioration of both the environment and
human health.
The symbol affixed to the device and displayed on its accompanying documents means that the PSPIX
system must not, under any circumstances whatsoever, be treated as household waste. It must therefore
be sent to a waste collection center capable of recycling electric and electronic equipment. Please comply
with current rules concerning waste disposal in the country of installation. For any further information
on the processing, collection and recycling of the machine, please do not hesitate to contact your dental
equipment distributor (or the website of the ACTEON group (www.acteongroup.com) to obtain information
on what action to take.
4.5. ELECTROMAGNETIC COMPATIBILITY
Guidance and manufacturer’s declaration – electromagnetic emissions
The PSPIX system is intended for use in the electromagnetic environment specified below. The
customer or the user of the PSPIX system should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment - Guidance
RF emissions
CISPR 11
Group 1
The PSPIX system uses RF energy only for its inter-
nal function. Therefore, its RF emissions are very
low and are not likely to cause any interference
in nearby electronic equipment.
RF emissions
CISPR 11
Class B The PSPIX system is suitable for use in
all establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic current emissions
EN 61000-3-2
Class A
Voltage fluctuations / Flicker
EN 61000-3-3
Compliant
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Guidance and manufacturer’s declaration – electromagnetic immunity
The PSPIX system is intended for use in the electromagnetic environment specified below. The customer
or the user of the PSPIX system should assure that it is used in such an environment.
Immunity test IEC 60601
test level Compliance level Electromagnetic environment Guide
Electrostatic
discharges
EN 61000-4-2
± 6 kV in contact
± 8 kV in the air
± 6 kV in contact
± 8 kV in the air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
Fast transient bursts
EN 61000-4-4
± 2 kV for supply
cables
± 1 kV for input/
output cables
± 2 kV for supply
cables
± 1 kV for input/
output cables
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage shocks
EN 61000-4-5
± 1 kV in differential
mode
± 1 kV in differential
mode Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
EN 61000-4-11
• < 5 % UT – (> 95 %
in immersion at UT
over 0.5 cycles)
• 40 % UT (> 60 %
in immersion at UT
over 5 cycles)
• 70 % UT
> 30 % in immersion at
UT over 25 cycles)
• < 5% UT
(> 95 % in immersion
at UT over 5 cycles)
• < 5% UT
(> 95 % in immersion
at UT over 0.5 cycles)
• 40% UT
(> 60% in immersion
at UT over 5 cycles)
• 70 % UT
(> 30% in immersion
at UT over 25 cycles)
• < 5% UT
(> 95 % in immersion
at UT over 5 cycles)
Mains power quality should be that of a typical
commercial or hospital environment. If the
user of a PSPIX system requires continued
operation during power mains interruptions,
it is recommended that the PSPIX system be
powered from an uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE:
UT is the a.c. mains voltage prior to application of the test level.
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Guidance and manufacturer’s declaration – electromagnetic immunity
The PSPIX system is intended for use in the electromagnetic environment specified below. The customer
or the user of the PSPIX system should assure that it is used in such an environment.
Immunity test IEC 60601
test level Compliance level Electromagnetic environment Guide
Conducted RF
EN 61000-4-6
Radiated RF
EN 61000-4-3
3 Vms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3V
3 V/m
Portable and mobile RF communications equipment
should be outside of recommended distance from
any part of the PSPIX system, including cables. The
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
d = 1.16√P
d = 1.16√P 80 MHz to 800 MHz
d = 2.33√P 800 MHz to 2.5 GHz
where is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a: should be less than the compliance level in each
frequency range.
b: Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1:At 80 MHz and 800 MHz, the higher frequency band applies.
NOTE 2:These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
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a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level
above, the PSPIX system should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the PSPIX system.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communication equipment and the PSPIX
system
The PSPIX system is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the PSPIX system can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the PSPIX system
as recommended below, according to the maximum output power of the communications equipment.
Nominal Maximal Output of
the device in W
Separation distance in meters (m) detIPined by transmitter frequency
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 √P d = 1.2 √P d = 2.3 √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
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4.6 SYMBOLS
The symbols displayed in this manual, on the labels below the PSPIX system and on its packaging comply
with international standards.
Warning! Do not reuse
Laser beam Serial Number
High voltage Manufacture date
Alternating current Manufacturer
Ethernet Upper temperature limit
Complies with the essential requirements of European
Directive 93/42/EEC concerning medical devices. Temperature limit
Disposal of commercial electric and electronic
equipment after 13 August 2005. This symbol denotes
that this product cannot be disposed with along with
household waste.
Keep out of direct sunlight
Unearthed class II power supply. The power supply plug
is used to disconnect the device from the electricity
network.
Upper humidity limit
Sensitive to electrostatic discharges Humidity limit
Autoclable at 134 °C Refer to the User Manual
Autoclable at 132 °C Catalog reference
ThIPo-disinfectable
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CONFIGURATION OF THE PSPIX SYSTEM
5.1 REQUIRED COMPUTER CONFIGURATION
To use the PSPIX system you must ensure that the computer and its peripherals have no limits on their use
for the safety of persons.
WARNING:
Only peripherals compliant with standard IEC 60950-1 can be connected to the PSPIX system Risk of PSPIX
system malfunction.
The computer must meet the following requirements:
Windows® Configuration:
MINIMUM CONFIGURATION RECOMMENDED CONFIGURATION
Operating system Windows® XP Pro SP3 Windows® 7 Pro SP1
Processor Intel® Pentium IV – 1.3 GHz Intel® Core i3 of higher
Memory 512 MB 2 Gb or more
Hard disk 250 Gb 500 Gb or more
Video card 32 MB individual RAM Video Card.
DirectX9 compatible
CHIPSET NVIDIA® graphics card
or dedicated ATI® / 512 MB RAM
individual video card. Compatible with
DirectX 9 or later.
Ethernet Card 100 Mb/s to 1 Gb/s 1 Gb/s
Screen resolution 1024 x 768 1280 x 1024 or more
CAUTION:
Risk of PSPIX system malfunction. For Ethernet port connections, use the CAT5 (RJ45) cable provided. It
can be directly connected to a computer or a local area network. This must be standardized according to
standards EN60950, IEC60950 or UL 60950.
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Mac® Configuration:
MINIMUM CONFIGURATION RECOMMENDED CONFIGURATION
Computer MAC® Book Pro 13.3’’ or iMac® 21.5’’ iMac® 27’’
Operating system MAC® OS X 10.9 MAC® OS X 10.9
Processor Intel® Core 2 Intel® Core i7
Memory 2 Gb 4 Gb
Ethernet Card 1 Gb/s 1 Gb/s
CAUTION:
Risk of PSPIX system malfunction. For Ethernet port connections, use the CAT5 (RJ45) cable provided. It
can be directly connected to a computer or a local area network. This must be standardized according to
standards EN60950, IEC60950 or UL 60950.
5.2 COMPATIBILITY WITH X-RAY GENERATORS
The PSPIX system is compatible with all intra-oral X-ray generators currently on the market. We nevertheless
recommend the use of ACTEON generators, which are perfectly adapted to the PSPIX systems.
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INSTALLATION AND SETTINGS
6.1 INSTALLATION OF THE PSPIX SYSTEM
WARNING:
Risk of electrocution and/or malfunction of the PSPIX system. Only specialist, trained technicians
approved by SOPRO are authorized to install and commission the PSPIX system.
- Position the PSPIX system as tabletop equipment in the dental clinic.
WARNING:
Risk of short circuit due to condensation. Only install the PSPIX system in a secure, dry and correctly
ventilated location. The ambient temperature must be not less than +10 °C and not more than +40 °C.
WARNING:
Risk of explosion. The PSPIX system is not intended for use in environments where there is a risk of
explosion or where the atmosphere is combustible. Areas subject to explosion may be created where
flammable products such as anesthetics, oxygen, cleaners and surface disinfectants are used.
CAUTION:
Risk of PSPIX system malfunction.
- Never leave the PSPIX system in direct sunlight or near to a bright light source. This allows for optimal
viewing of the information displayed on the PSPIX system’s touch screen .
- Risk of PSPIX system malfunction. Avoid the presence/ interference of radiation sources (magnetic
fields for example) in the room where the equipment is installed.
- Risk of PSPIX system malfunction. The PSPIX system must be positioned on a flat and stable surface to
avoid any risk of vibration that may harm the image quality.
- Risk of PSPIX system malfunction. The PSPIX system must not be stacked on or placed in contact with
other items of equipment.
- Connect the PSPIX system to the electrical mains.
ON AN
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