Acteon SOPROCARE User manual

User’s manual
Manuel d’utilisation
Manual de usuario
Manuale d’uso
Betriebsanleitung
Gebruikershandboek
使用手册

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Contents
FOREWORD.......................................................................... 2
DENTAL CAMERA INTRODUCTION ................................................ 3
SAFETY INSTRUCTIONS ............................................................ 6
REGULATORY REQUIREMENTS..................................................... 7
INSTALLATION.................................................................... .13
CONNECTING TO A VIDEO SCREEN ............................................ .15
CONNECTING TO A COMPUTER ................................................ .17
PERIO MODE AND CARIO MODE ................................................ .20
DESCRIPTION OF THE CONNECTION BOXES.................................. .23
SOPROTIPS STERILIZATION .................................................... .26
MAINTENANCE ................................................................... .27
AFTER-SALES SERVICE .......................................................... .29
TECHNICAL FEATURES .......................................................... .32

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FOREWORD
To optimize the use of this device, whilst taking all the necessary precautions, we recommended you read carefully and follow the
owner’s manual.
Please carefully consider the messages “CAUTION”, “WARNING”, and “NOTE” when using the system.
CAUTION: the term CAUTION describes potential incidents likely to jeopardize safety.
!
WARNING: the term WARNING refers to the incidents likely to disturb the smooth running of the imaging system.
NOTE : the term NOTE highlights particular points in order to facilitate the system maintenance or to clarify important information.
REWO

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DENTAL CAMERA INTRODUCTION
The SOPROCARE is intended for the clinical practice of general dentistry, focused on the concepts of prevention, prophylaxis,
complete and fast checkup of patient’s oral health status. This system is a device to assist dentists and/or hygienists in their
preventive care and their visual diagnosis. It provides the following benefits:
• Information about patient dental hygiene
• Highlight dental plaque and gingival inflammation in relation to these deposits
• Aids in the detection of groove caries
• Show the difference between “before” and “after” care.
In PERIO mode, the camera helps the dental practitioner to see the presence of dental plaque but also to highlight gingival
inflammation due to this deposit. This mode offers to the dentist and/or hygienist a tool for a better communication, motivation and
education of his patients, who will then become aware of their oral health condition.
In CARIO mode, the camera helps the dental practitioner to highlight carious warning on fissures of the occlusal side of the teeth.
In DAYLIGHT mode, the camera enables you to visualize anatomical details invisible to the naked eye or with a mirror.
This fluorescence Imaging device is composed of a handpiece (SOPROCARE) and a connection box (DOCK M_USB2, DOCK M_VIDEO,
DOCK MU_USB2, DOCK U_USB2, DOCK MU_VIDEO, DOCK USB2) as well as various accessories necessary for it to work.
SOPROCARE
• 1 handpiece integrating the camera electronics and lighting.
• 1 handpiece holder.
• 4 SOPROTIPS.
• 10 dental barriers.
• CD of SOPRO Imaging software (in basic version) including documentations.
• A quick start of SOPROCARE and SOPRO-Imaging software
DOCK M_USB2
• A connection box with integrated image memory and USB2 digital output.
RA

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• Power supply.
• A 2.5 metre cable to connect the handpiece to the connection box (5 metres and 7 metres optionally).
• An S-video Y/C cable
• An RCA video cable.
• A USB cable.
DOCK M_VIDEO
• A connection box with integrated image memory.
• Power supply.
• A 2.5 metre cable to connect the handpiece to the connection box (5 metres and 7 metres optionally).
• An S-video Y/C cable
• An RCA video cable.
DOCK USB2
• A USB2 connection box with a 3.5 metre connecting cable.
• CD of SOPRO Imaging software (in basic version) including documentations.
• A quick start of SOPRO-Imaging software
DOCK MU_VIDEO
• A connection box with integrated image memory.
• A 2.5 metre cable to connect the handpiece to the connection box (5 metres and 7 metres optionally).
• An installation manual.
DOCK U_USB2
• A connection box with USB2 digital output.
• A 2.5 metre cable to connect the handpiece to the connection box (5 metres and 7 metres optionally).
• An installation manual.
DOCK MU_USB2
• A connection box with integrated image memory and USB2 digital output.
• A 2.5 metre cable to connect the handpiece to the connection box (5 metres and 7 metres optionally).
• An installation manual.

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This device has been packaged in a custom carton. This carton should be kept for future possible transportation. As a complement
to the dental camera, we provide some dental barriers necessary for intra-oral use of dental camera. For more details about these
products, please refer to our catalogue or contact our commercial service.
NOTE :
The device was designed and developed with its accessories in order to guarantee to you safety and performance maximum. The
use of different origin accessories can represent a risk for you, your patients and your device.

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SAFETY INSTRUCTIONS
• DO NOT expose the SOPRO camera to water spray and do not store it in a humid environment (to prevent risk of electrocution).
• When handling camera and dental barriers, always take the appropriate hygiene measures and precautions in order to prevent
cross contamination risks.
• Infection control procedures must be observed when using accessories such as SOPROTIPS and dental barriers. When using
accessories always follow the manufacturer’s instructions on how to use said accessory and prevent cross contamination risk from
one patient to another.
• Install the camera in a clean, dry, and well-ventilated place.
• Disconnect the connection box from the power supply if you are not going to use it for several days. Do not pull on the cable.
• DO NOT compress or nip the handpiece cable.
• DO NOT expose the product to high vibrations.
• DO NOT drop the handpiece.
• Handpiece should NEVER be immersed in any liquid, NOR should it be autoclaved.
• For each new patient, it is essential to use the dental barriers provided with the handpiece. Before using the camera, make sure
it does not have any sharp edges.
• The surface temperature in the light emission area can reach above 41°C (after several minutes of use). Therefore avoid maintaining
this emission area in contact with the patient’s mouth.
• The camera is a product using group 1 LEDs according to IEC 62471. To avoid any ocular risk do not look directly at the light.
NOTE :
If the hygienic protection is torn while examining a patient or if the handpiece was “infected” while withdrawing the hygienic
protector, it is essential to totally disinfect the handpiece. In order to do this: please refer to the maintenance chapter.
CAUTION:
Modification of the product, without the permission of the manufacturer, is prohibited.
CAUTION:
If the medical equipment is changed, an appropriate control and test should be performed to ensure that the medical equipment
still can be used safety.
NSTR

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REGULATORY REQUIREMENTS
4.1. COMPLIANCE WITH STANDARDS AND REGULATIONS
This product was designed and manufactured by a company having an authorized quality system. It meets the European directive
93/42/EEC requirements relative to medical devices. Therefore, it particularly meets electrical safety and electromagnetic
compatibility standards (IEC) (CEM).
4.2. ELECTROMAGNETIC INTERFERENCE AND ELECTROSTATIC DISCHARGES
Electromagnetic compatibility (CEM) is the ability of electronic device elements to correctly interact in an electronic environment.
Although the SOPRO system was designed according to this compatibility and complies with the electromagnetic interference
thresholds established by the regulatory agency, there is no guarantee about interference likely to occur on a particular installation.
If the device generates interference with radio communication services (which can be determined by switching it off and on), it is
recommended to try to correct this phenomenon by taking whole or part of the following measures:
• Change the receiving antenna orientation
• Reposition the product according to the receiver.
• Take the computer away from the receiver.
The SOPRO camera is designed and tested to be used in a home environment, class B Group 1, according to CISPR11 standard.
YRE

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4.3. MEDICAL DEVICE VIGILANCE
As with any medical device, this device is subjected to medical device vigilance dispositions; any serious dysfunction should then be
the subject of a description to the competent authorities and to the manufacturer as soon as possible and as precisely as possible.
4.4. END OF LIFE
This device bears the recycling symbol according to the European directive 2002/96/EC about electric and electronic equipment
waste (DEEE or WEEE). By correctly disposing of this device, you will contribute to avoiding any damage to the environment and
human health.
The symbol on the device or on the accompanying documentation indicates this product cannot be, in any case, treated as
household waste. Therefore, it should be transferred to a waste collection centre that handles electric and electronic equipment
recycling. Please respect the standards relative to waste disposal in force in the installation country. For more details about the
device treatment, recuperation and recycling, please contact your dental device distributor (or failing that, the group ACTEON site
www.acteongroup.com), so that you can be informed of the procedure.

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4.5. ELECTROMAGNETIC COMPTABILITY
Guide and declaration of the manufacturer - electromagnetic emissions
SOPRO device is intended to be used in the electromagnetic environment specified below.
The user should make sure it is used in this environment.
Emission trial Compliance Electromagnetic environment - Guide
RF emissions
CISPR 11 Group 1
SOPRO device only uses radio energy for its internal functions.
Therefore, its RF emissions are very low and are unlikely to cause
interference with nearby electronic devices.
RF emissions
CISPR 11 Class B
SOPRO device may be used in all domestic environments, including
the ones directly connected to the public low voltage power
distribution network used to supply household buildings.
Harmonic emissions
EN 61000-3-2 Not applicable
Voltage fluctuations / Flicker
EN 61000-3-3 Applicable

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Guide and declaration of the manufacturer - electromagnetic immunity
SOPRO device is intended to be used in the electromagnetic environment specified below.
The user should make sure it is used in this environment.
Immunity trial CEI 60601
Severity level
Compliance
level
Electromagnetic environment
Guide
Electrostatic
discharges
EN 61000-4-2
± 6 kV when in contact
± 8 kV in the air
± 6 kV
± 8 kV
The floor should be wooden, concrete or tile. If the
floor is covered with a synthetic material, the relative
humidity should be at least 30%.
Far transient bursts
EN 61000-4-4
± 2 kV for the feed cables
± 1 kV for the input/out-
put cables
± 2 kV
± 1 kV
The main power supply quality should be one of a
traditional commercial or hospital environment.
Voltage shocks
EN 61000-4-5
Differential mode ± 1 kV
Common mode ± 2 kV
± 1 kV
N.A.
The main power supply quality should be one of a
traditional commercial or hospital environment.
Dips, brief outages
and power voltage
variation
EN 61000-4-11
• <5% Ut - for 10 ms
• 40% Ut - for 100 ms
• 70% Ut - for 500 ms
• <5% Ut - for 5 s
<5% Ut 10 ms
<40% Ut 100 ms
<70% Ut 500 ms
<5% Ut 5 s
The main power supply quality should be one of a
traditional commercial or hospital environment.
If the user of SOPROCARE device requires it to continue
to operate during main power supply outages, it is
recommended SOPROCARE device is fed by an inverter
or a battery.
Magnetic field with the
network frequency
(50/60 Hz)
3 A/m 3 A/m
The magnetic field with the network frequency should
be at a characteristic level of a location in a traditional
commercial or hospital environment.
Note: Ut is the power voltage nominal value applied during the trial.

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Guide and declaration of the manufacturer - electromagnetic immunity
SOPRO device is intended to be used in the electromagnetic environment specified below.
The user should make sure it is used in this environment.
Immunity trial CEI 60601
Severity level
Compliance
level
Electromagnetic environment
Guide
Conducted RF
EN 61000-4-6
Radiated RF
EN 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3V
3V/m
Portable and mobile RF communication devices should not
be used at a distance from SOPRO device including the
cables, lower than the recommended separation distance,
calculated with the applicable formulas depending on the
emitter frequency.
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 rated output of the transmitter
in watts (W) by the transmitter manufacturer and d the
recommended separation distance in metres (m).
The field levels emitted by the fixed RF transmitters,
determined by an electromagnetic measurement of the
sitea, should be lower than the compliance level in each
frequency band b.
Interference may occur in the vicinity of the devices bearing
the following symbol:
Note 1 : At 80 MHz and 800 MHz, the higher frequency band applies.
Note 2 : These recommendations may not apply in every situation. Electromagnetic wave propagation is modified by the
absorption and reflection due to the structures, objects and persons.

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aThe fixed transmitter field levels, such as the base stations of the radio telephones (cellular/wireless) and the terrestrial
mobile radios, domestic radio, AM, FM, and TV radio communication cannot be theoretically assessed precisely. To obtain the
electromagnetic environment due to the fixed RF transmitters, a site measurement should be performed. If a field level measured
in the use environment of SOPRO device exceeds the compliance levels above applicable, the good operation of SOPRO device
should be checked. If abnormal operations are proved, some further measures should be taken, such as reorientation or relocation
of the standard device.
b Above the 150 kHz to 80 MHz frequency band, the field level should be lower than 3 V/m.
Recommended separation distances between the portable and mobile RF communication devices
and SOPRO device
SOPROCARE device is intended to be used in an electromagnetic environment in which the irradiated RF disturbances are
checked. The user of SOPRO device can help to avoid electromagnetic interference by maintaining a minimal distance between
the portable and mobile RF communication devices (transmitters) and the recommended SOPRO device such as recommended
below, depending on the maximum output power of the communication device.
Rated maximal
output power of the
transmitter
W
Separation distance depending on the transmitter frequency - m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
d = 1.6 √P d = 1.6 √P d = 2.33 √P
0.001 0.116 0.116 0.233
0.1 0.366 0.366 0.736
1 0.16 1.16 2.33
10 3.66 3.66 7.36
100 11.6 11.6 23.3
For the transmitters whose maximal output is not listed above, the recommended separation distance d in metres (m) can be
determined by using the equation applicable to the transmitter frequency, where P is the maximal output of the transmitter in watts
(W) rated by the transmitter manufacturer.
Note 1 : At 80 MHz and at 800 MHz, the separation distance given in the higher frequency band applies.
Note 2 : These recommendations may not apply in every situation. The electromagnetic wave propagation is modified by absorption
and reflection due to the structures, objects and persons.

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INSTALLATION
The device is intended to be used by a dental practitioner. Its installation does not require any special training. Consult the
instructions in this manual.
5.1. CONNECTING
Fastening the handpiece holder:
1. Choose a plain area that can be easily accessible for use.
2. Use the wipe provided to clean the surface on which you are going to fasten the holder.
3. Remove the double-sided adhesive tape protection that is on the support, place it, and then press it into place several times.
The maximum sticking performances are obtained after two hours,so avoid any stress on the holder during this two hour period.
!
CAUTION :
This holder is equipped with magnets that can damage devices sensitive to magnetic fields. Make sure you do not install this holder
near these devices (cathode ray tube video screen, magnetic videotapes, etc.)
5.2 FURTHER CONNECTION BOXES (optional)
You can install a connection box near each dental chair (no limitation). You will just have to transport the handpiece from one chair
to the other.
The handpiece holder is intended to maintain the connecting cable connector when the cable is not linked to the handpiece. When
you disconnect the handpiece connecting cable to take it to another chair (or when you put the handpiece on its holder), the last
stored image is displayed on the screen or the last four if you were in four-image mode, or the colour-bar pattern if no image was
stored (except on Dock USB2 and Dock U_USB2).
ALLA

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5.3. FOCUSING ADJUSTMENT
On the handpiece, there is a rotating ring used to focus from “0” to infinite. To simplify handling, we have pre-set four positions
corresponding to the main camera uses.
Extra-oral (Portrait).
Intra-Oral (1 to 5 teeth).
CARE (diseases observations)
Macro (details that cannot be seen with naked eye).

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CONNECTING TO A VIDEO SCREEN
6.1. CONNECTION OF DOCK M_USB2 OR DOCK M_VIDEO
• Connect the video cable (preferably Y/C “S-video”) between the connection box and the monitor video input
• Connect the connecting cable between the connection box and the handpiece.
• If you prefer using a footswitch rather than SoproTouch to freeze the image, you just have to connect the footswitch
(optional) to the connection box. With this configuration, SoproTouch is inhibited.
• Connect the power supply to the outlet, and then to the connection box (the green indicator light should be on).
• Only use the power supply provided with the connection box.
6.2. CONNECTION OF DOCK MU_USB2 OR DOCK MU_VIDEO
• Please refer to DOCK MU_USB2/DOCK MU_VIDEO integration manual for its connections.
• Connect the connecting cable to the handpiece.
• Connect the video cable (preferably Y/C “S-video”) between the connection box and the monitor video input.
6.3. OPERATION OF SOPROTOUCH IMAGE FREEZE ON CAMERA
• When powering on, the camera automatically selects the one-image mode.
• To switch to four-image mode, press SoproTouch or more than three seconds (until a black flash appears on the screen or, if
TO A

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you have chosen to use a footswitch, press it for more than three seconds).
• Perform the same procedure to switch back to one-image mode.
• In one-image mode, you just have to slightly touch SoproTouch (or briefly press the footswitch once) as soon as the desired
image appears on the monitor. The image is automatically stored in the camera and displayed on the screen. If you want to return
to direct mode, you just have to slightly touch SoproTouch once more (or press the footswitch).
• Another little gentle touch on SoproTouch (or press on the footswitch) will freeze another image by deleting the previous
one.
• In four-image mode, the image is stored in one of the quarters of the screen when you slightly touch SoproTouch (or press
the footswitch) and remains displayed on the screen. Another little slight touch on SoproTouch (or press of the footswitch)
will return the image to direct mode. A third little slight touch (or press) will store a second image in another quarter of the screen
and so on until obtaining the four images.
NOTE :
The footswitch must be conformed IPX1 according to IEC 60529 standard (Article 15.4.7.3 of IEC 60601-1 ed3 standard).

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CONNECTING TO A COMPUTER
7.1. REQUIRED CONFIGURATION FOR THE COMPUTER
To use the SOPRO device, you must make sure the computer and its peripherals do not have any usage limitation that could concern
personal safety. It should also meet the following requirements:
Windows® configuration:
Minimal Configuration Recommended Configuration
Operating system Windows® XP Pro SP3 Windows® 7 Pro SP1
Processor Intel® Pentium IV – 1,3 GHz Intel® Core 2
Memory 512 MB 2 GB or more
Hard disk 250 GB 320 GB or more
USB ports 2 USB2.0 Hi-Speed ports 4 USB2.0 Hi-Speed ports
Video board Graphic board 32 MB of unshared video RAM
compatible with DirectX 9
Chipset Nvidia or ATI / 512 MB RAM unshared
video RAM compatible with DirectX 9 or
higher.
USB Chipset Intel or NEC® / RENESAS® Intel or NEC® / RENESAS®
Screen resolution 1024 x 768 1280 x 1024 or more
MAC® configuration:
Minimal Configuration Recommended Configuration
Computer MAC® Book Pro 13.3’’ ou iMac® 21.5’’ iMac® 27’’
Operating system MAC® OS X 10.6 Snow Leopard MAC® OS X 10.7 Lion
Processor Intel® Core 2 Intel® Core i7
Memory 2 GB 4 GB
GTO

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7.2. DOCK M_USB2 CONNECTION
• Connect the USB cable between the connection box and one of the computer USB ports.
• Connect the connecting cable between the connection box and the handpiece.
• If you prefer using a footswitch rather than SoproTouch to freeze the image, you just have to connect the footswitch (optional) to
the connection box. With this configuration, SoproTouch is inhibited.
• Connect the power supply to the outlet, and then, to the connection box (the green indicator light should be on).
7.3. DOCK MU_USB2 OR DOCK U_USB2 CONNECTION
• Refer to DOCK MU_USB2 / DOCK U_USB2 integration manual.
• Connect the connecting cable to the handpiece.
• Connect the USB cable between the connection box and one of the computer USB ports.
7.4. DOCK USB2 CONNECTION
• Connect the USB cable to one of the computer USB ports.
• Connect the connecting cable to the handpiece.
7.5 SOPRO IMAGING SOFTWARE INSTALLATION
Refer to the Sopro Imaging owner’s manual that is on the Sopro Imaging CD-ROM in the document directory.
7.6. SOPRO IMAGING SOFTWARE CONFIGURATION WITH THE CAMERA
Refer to the Sopro Imaging owner’s manual that is on the Sopro Imaging CD-ROM in the document directory.

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7.7 USING SOPRO IMAGING SOFTWARE WITH CARE FUNCTION
Refer to the Sopro Imaging owner’s manual that is on the Sopro Imaging CD-ROM in the document directory.