Comeg SYMBIOZ Cam+ User manual

INTUITIVE
CONNECTION
Cam+
User manual
Manuel utilisateur
Manual del usuario
Manuale utente
Benutzerhandbuch
Gebruikershandleiding
Podręcznik użytkownika

2

User manual 5
Manuel utilisateur 37
Manual del usuario 69
Manuale utente 101
Benutzerhandbuch
133
Gebruikershandleiding
165
Podręcznik użytkownika 197
3
Cam+

4

INTUITIVE
CONNECTION
English
ENGLISH
5

ENGLISH
66

ENGLISH
7
1Preface 8
2Introduction to the apparatus 9
3Safety instructions 10
4Regulatory advice 12
5Installing the apparatus 13
6Operating guidelines 16
7Description of the front and back panels 22
8Suggested decontamination procedures 24
9Aer-sales service and maintenance 26
10 Troubleshooting 27
11 Technical characteristics 29
12 Electromagnetic compatibility 30
13 Symbols 34
Contents
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Cam+

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1Preface
We thank you for your purchase of the SYMBIOZ Cam+ by Sopro-Comeg.
In order to make the best use of it while having all the necessary precautions at your disposal,
it is essential for you to become acquainted with this manual.
The sentences displaying the symbol correspond to points requiring special attention.
The sentences displaying the symbol represent items of information.
To facilitate installation and use of the apparatus, we have attempted to make the device manual more
practical. Consequently, references to the product presentation on page 35 (like C1 for example) will
be provided for easier viewing of the relevant product parts.
This user manual is an integral part of the device. It must be made available to the user.
Proper use and correct handling of the device entail following these instructions.
The user alone shall be responsible for any damage that may result from improper use.

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2Introduction
to the apparatus
SYMBIOZ Cam+ is a Cmos FULL HD medical camera.
Its ergonomically designed sensor, automatic shutter, good sensitivity, excellent resolution and faithful
color-rendering make it ideal as a medical tool for rigid or flexible endoscopy.
This camera comes with:
• A control unit,
• A camera head with integrated 15-35 mm zoom lens,
• Video cables,
• A power cable,
• A peripheral cable,
• Two communication (SOPROCOM) cables,
• A set of 6 Smartcards,
• A user manual,
• A Quickstart guide.
For the United States and Canada, the “hospital grade” power cord supplied and the
connector must be used with a “hospital grade” mains socket.
This equipment has been delivered to you in packaging to be retained for use if transporting the device.

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3Safety instructions
Read the user manual.
This user manual is an integral part of the apparatus. It must be made available to the user.
Proper use and correct handling of the apparatus entail following these instructions.
The user alone shall be responsible for any damage that may result from improper use.
• Comply with the conditions of use and storage.
• Do not expose the apparatus to excessive dust.
• The apparatus should be opened only by a competent technician authorized by the manufacturer.
• Do not insert metal objects into the apparatus. This is to avoid any risk of electrical shock, fire,
short-circuit or hazardous emissions.
• Do not expose the apparatus to splashed water or to damp.
• Use only the accessories supplied with the apparatus or recommended as options by the
manufacturer.
• This camera is not a flame-proof device. Therefore, it must not be used in the presence of flammable
anaesthetics.
• This apparatus was not designed to be used in an ionising environment.
• This apparatus is not sterile.
• The surface temperature of the camera can reach 41°C (aer a few minutes’ use). Therefore, avoid
any contact with this area.
• The camera is intended for use by qualified, trained professionals, in an operating theatre.
• Prior to plugging in the apparatus, check that the mains voltage and mains frequency indicated on
the apparatus correspond to the power system values.
• Prior to activation, ensure that neither the apparatus nor the power cable is damaged.
Deteriorated cables and connectors must be replaced immediately.
• Do not drop the apparatus. If the apparatus falls, do not reconnect the apparatus but send it back to
your authorised distributor or directly to the Sopro-Comeg aer-sales service department.
• No additional multiple-socket outlets or extension cords must be connected to the EM system.
To avoid any risk of electrical shock, this device must be connected only to a power system equipped
with protective grounding.
Apparatuses connecting to the input/output ports must comply with the IEC 60950-1 standard.
Any modification of this device without authorisation from the manufacturer is prohibited. If the
medical device is modified, an inspection and a test must be carried out to ensure that the medical
device complies with the safety regulations.

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3Safety instructions
Check with the manufacturer regarding the compatibility of your endoscope and your light source,
prior to use.
It is advisable to have a second surgical camera in the operating theatre so that action can be
taken if the device fails to perform or if deterioration in performance is noticed.
This device is to be used on individuals (patients) fit to undergo an endoscopic procedure.
The potential equalization plug located at the back of the medical apparatus can be used to equalize
the grounding potential of the medical device with that of all the apparatuses plugged into the power
main in the environment. Use the shared grounding system in the hospital or the building.
Other cables and accessories may negatively aect EMC performance.
Stacking and location close to other equipment may negatively aect EMC performance.

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4Regulatory advice
4.1 Compliance
This product was designed and manufactured by a company with a certified quality system.
It meets the requirements of European directive 93/42/CEE, on medical devices.
Consequently, it particularly meets the standards of electrical safety (IEC) and electromagnetic
compatibility (EMC) ad hoc.
4.2 Electromagnetic interferences and electrostatic
discharge
Although this product complies with EMC standards, it may in very special circumstances interfere with
other devices, or itself be the object of interference from other apparatuses or an unfavorable electro-
magnetic environment.
This medical electrical equipment needs special precautions regarding EMC and needs to be installed
according to EMC information.
Mobile RF communications equipment can aect this medical electrical equipment.
Image transfers from the camera to a monitor may be susceptible to electromagnetic disturbances and
electric system disturbances.
In order to avoid these situations, it is advisable to:
• Ensure of the quality of the electric power system (especially the grounding of all apparatuses and
medical carts).
• Keep the apparatus away from electromagnetic sources (e.g. compressors, motors, transformers,
HF generators, etc.).
4.3 Medical device vigilance
Like any medical device, this apparatus is subject to the stipulations governing medical device vigilance,
and therefore any serious malfunction must be reported to the competent authorities and to the
manufacturer as quickly and as accurately as possible. For manufacturer contact details, refer to the
last page of the manual.
4.4 End of lifecycle
This apparatus carries the recycling symbol in compliance with European directive 2002/96 CEE on Waste
Electrical and Electronic Equipment (DEEE or WEEE). By correctly disposing of this apparatus you are helping
to prevent harmful eects on the environment and on human health.
The symbol displayed on the apparatus and on the accompanying documentation indicates that
this product cannot under any circumstances be treated as household waste. It must therefore be
delivered to a waste collection center for the recycling of electrical and electronic equipment.
In disposing of it, please comply with the waste elimination norms in eect in the country where
it is installed.
For further details on the treatment, recovery and recycling of this apparatus, kindly contact your
nearest retailer who will advise you on the procedure to follow.

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5Installing the apparatus
This medical device is intended for use by a qualified surgeon during endoscopic exploration.
No special training is required to install it. Kindly refer to the instructions in this manual.
Place the control unit on its base and have to hand the various accessories required to operate it.
5.1 Connections
• Connect the power cord to the mains socket of the camera C2 and a video lead to one of the video
output ports: we recommend selecting the DVI output C6 for connecting the main surgical monitor.
• Connect the second end of the video lead to the video input port on the monitor.
• If you wish to control certain functionalities of the insuator or the light source, connect these to
the SOPROCOM socket on the camera’s control unit C9 intended for this purpose, using the two
cables provided.
Connecting the endoscope to the sensor:
• Turn the ring on the endoscope-holder on the camera head clockwise.
• Once the endoscope is inserted, release the ring.
• If the sensor has to be locked into position on the endoscope, the ring should be turned in the opposite
direction.
• Connect the potential equalization cable to the equipotential plug C13 at the back of the apparatus.
5.2 Activation
To optimize the quality of the images obtained with this product, always be sure to connect the
camera head before turning on the control unit.
• Connect the power cable to the plug C2 at the back of the camera.
• Connect the DVI-D cable to the corresponding output port C6 at the back of the product and to
the corresponding input port on the monitor.
èThe DVI-D output produces a progressive 1080 signal.
• If needed, connect other monitors or peripherals, preferably using the HDSDI & 3GSDI
output ports C8 .
èHDSDI, 3GSDI output ports produce an interleaved 1080 signal.
èHDSDI, 3GSDI output ports are preferred when a very long cable is necessary.

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5Installing the apparatus
• Turn the activation switch S2 to position “1”.
èThe camera takes about 30 seconds to come on. The Comeg logo is displayed on the screen during
this interval.
èThe flashing LED Standby button, and the appearance of “Standby” on the screen
indicate that the camera is properly activated.
• Connect the camera head to the control unit via the dedicated connector C1 .
• Touch the screen, OR press the standby button to access the main menu.
• Select a surgical specialty from Laparoscopy, Hysteroscopy, Cystoscopy, ENT, Arthroscopy and
Flexible Endoscopy, by clicking the associated symbol.
èOnce the selection is made, the camera is in surgery mode.
• Aer connecting the light cable and the endoscope, film a white surface and launch the White
Balance by pressing the dedicated button on the touch screen interface, or the camera head’s
pre-programmed button.
èWhen the surgical monitor appears indicating “AWB OK” and the chronometer starts, this signals
that the white balance has successfully been set.
èThe chronometer shows the operating time by default (the starting point being when the white
balance is set). However, this chronometer can be set beforehand if necessary, independently of the
white balance.
• The video settings have been defined for each surgical specialty. However, they can be modified,
if necessary, during surgery.
è3 of these (Brightness, Sharpness and Red Gain) can be directly accessed from the main screen.
All the others (Gamma, Blue Gain, Color, Red Phase, Gain, Noise Reduction, and Aperture) can be
accessed by clicking the “More Settings” button. This is a drop-down list. To scroll through the
parameters, touch the le section (the parameter headings) with your finger.
• Press “Close settings” to exit and return to the main screen.
• You can at any time during surgery to return to the factory settings for the surgical specialty by
clicking the “Specialities presets” button.
• Press the “STOP” button at the end of the surgery.
You can at this stage:
Return to the main menu by clicking the “Completed” button;
OR
Create a user profile from the settings used during the operation;
OR
Log in if you wish to add this set of settings to your profile.

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5Installing the apparatus
Before connecting an endoscope (or fibroscopes) to the camera lens, check the condition of this
endoscope (clean distal lens, setup if necessary).
5.3 Activating the device from a Smartcard
• Scan a Smartcard on the read area provided on the lexan housing (next to the Comeg logo).
• Scanning a standard Smartcard:
èActivate the camera directly on the surgical screen, in the surgical application corresponding to
the Smartcard scanned.
• Scanning a personal Smartcard:
èActivate the camera directly on the surgical screen, in the surgical preset corresponding to the
Smartcard scanned. If the user profile associated with the Smartcard scanned shows more than one
preset, then an intermediate stage for selecting the desired preset will be necessary.
• Scanning an administrator Smartcard:
èActivate the camera in the administrator menu.

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6Operating guidelines
6.1 Selecting the surgical speciality
This camera can be used in various mini-invasive surgical operations.
Select the specialty from the pre-entered list. This loads the video parameters for the application
accordingly:
LAPAROSCOPY
HYSTEROSCOPY
CYSTOSCOPY
ENT
ARTHROSCOPY
FLEXIBLE ENDOSCOPY
Note 1: Each of these specialties can be accessed by scanning the Smartcard on its dedicated area Z1
on the control unit. This can be done at any time. If the Smartcard is scanned while a surgical operation
is in progress, then confirmation will be requested.
Note 2: If you have entered customized parameters into a user profile beforehand, then you can select
this user profile either by using the “Log in” button, or by scanning your personal Smartcard on the
dedicated area Z1 of the control unit if the control unit is linked to your personal profile.
6.2 Configuring the functions of the camera head buttons
This operation is performed on the corresponding page of the menu interface, which can be accessed
from the dedicated “Camera head” button:
Click the button you wish to configure (B1, B2 or B3).
Select the type of press (short press or long press) and the corresponding function desired, and confirm.
Repeat this procedure for each of the three buttons.
The configuration selected for each of the three buttons will be entered into the user’s personal profile.

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6Operating guidelines
Below is the comprehensive list of the configurable functions:
By default, the following configuration is applied (factory setting):
B1 (short press / long press): Brightness - / Light source.
B2 (short press / long press): Brightness - / Insuator.
B3 (short press / long press): No action / AWB.
Mirror mode: an “M” is displayed on the monitor to indicate that the mirror mode (inverted image)
is active, and disappears when it is deactivated.
Freeze mode: an “F” is displayed on the monitor to indicate that the freeze mode is active, and
disappears with it is deactivated.
Peripheral 2 Peripheral 2
Mirror Mirror
Freeze frame Freeze frame
Recording images on the camera
(if equipped with an integrated recorder)
AWB
Record / Stop video recording on the camera
(if equipped with an integrated recorder)
Insuator (RUN / High Flow Rate / STOP)
Light source (ON / OFF)
(a) Recording images on the PC Recording images on the camera
(if equipped with an integrated recorder)
(b) Record / Stop video recording on the PC Record / Stop video recording on the camera
(if equipped with an integrated recorder)
(a) Recording images on the PC
(b) Record / Stop video recording on the PC
Type of press
Short press Long press
No action No action
Brightness + Brightness +
Brightness - Brightness -
Light source - Intensity + Light source - Intensity +
Light source - Intensity - Light source - Intensity -
Peripheral 1 Peripheral 1

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6Operating guidelines
6.3 White balance
The white balance can be set in 2 ways:
• From the touch screen interface, click the white balance button.
• From one of the camera head buttons, depending on your programming (only possible with long press).
You should proceed as follow:
• Once the camera is paired with the endoscope, the ambient light reduced to a minimum and the
light source active, film a white surface.
• Set the white balance; the “BALANCING IN PROGRESS” message is displayed on the screen.
• Continue to film the white surface until the “BALANCE OK” message is displayed on the screen.
Note 1: Setting the white balance causes the chronometer to be activated, signaling the start of the
surgery and therefore the availability of additional functionalities, particularly those linked to the image
quality settings.
Note 2: If the light source is connected to the camera by the communication cable supplied, then setting
the white balance will cause the LED to light up if it was previously o.
In the event that the white balance is set during an operation, i.e. inside the patient, the endoscope
must be pulled out of the trocar and the white balance must be set again using gauze.
6.4 Focusing
Once the endoscope is connected and the light source is activated, slowly turn the lens focus ring to
find a position where the objects being observed are sharp.
Focusing on a fairly distant point helps obtain adequate field depth for the operation and therefore
avoids having to do retouching too regularly.
6.5 functionalities
•6.5.1 Video settings
Once the white balance is set, or the “Start” button has been pressed, access to the video settings is
authorised.
In this way, it is possible to work directly on brightness, sharpness and red gain.
Additional settings are available by clicking the “More settings” button.

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6Operating guidelines
The following parameters can be modified:
Click the “Close settings” button once to return to the previous menu.
•6.5.2 Other parameters
HD Recording:
You can set HD image/video recording from the interface menu using the corresponding buttons or
from the buttons on the camera head if these have been programmed accordingly.
Insuator:
If your camera is connected to the Symbioz Flow insuator via the communication cable provided, you
can select from the parameters menu whether or not to display information about the operating status
of the insuator on the surgical monitor’s OSD.
In particular:
Feedback on instantaneous pressure in the pneumoperitoneum;
Feedback on warning messages from the insuator.
In addition, one of the buttons on the camera head can be configured (long press only) to control the
Symbioz Flow insuator according to the following sequence:
Start insuation in low flow / Change to high flow / Stop insuation.
BRIGHTNESS This parameter varies the general brightness of the image
BLUE GAIN Colorimetry shi from white to blue
RED GAIN Colorimetry shi from white to red
COLOR Modifies color saturation
NOISE REDUCTION Reduces the noise in an image
WINDOW Shutter window analysis:
surface of the image on which the camera analyses the quantity of light received, in
order to adjust the speed of the shutter to obtain a right exposure time.
Use the automatic mode or change it according to the scope size.
GAMMA Modifies the dynamics of the dark areas:
+1 reduces the dierence between the light portions and the dark portions, therefore
making these dark areas appear less so.
-1 does the opposite: the dark portions are made even darker.
SHARPNESS Modifies the sharpness of the image to obtain a 3D eect or on the other
hand, soens the image with the “anti-moiré” filter for flexible endoscopes
GAIN Modifies the brightness level in cases of mediocre lighting conditions
RED PHASE Colorimetry phase shi from Orange to Magenta

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6Operating guidelines
6.6 Completion
Once the operation is completed, press the “STOP” button. You will be given the option:
- To create a user profile;
- To log in, if you have not already done so;
- To save any modifications to the settings in your personal profile, if you have not already done so;
- To exit.
Note: If you are already logged in, you can opt to save the modifications to your personal profile.
In particular you will be able to save:
- Modifications to the video settings;
- Modifications to the light source intensity setting (last setting used);
- Modifications to the insuator pressure setpoint (last setting used, with 15 mmHg limitation,
and mode);
- Modifications to the settings on the surgical monitor supported models only);
Once the selection has been made, you can overwrite the existing preset, or create another one.
6.7 General settings menu
The general settings menu is used to:
- Set the light intensity on the touch screen.
- Select the display messages and the display of the instantaneous pressure in the pneumoperitoneum,
from the insuator.
- Select the language.
- Pause the live video when a photo is taken to verify its quality.
6.8 Information menu
The information menu is used to access a rapid start-up product guide.
6.9 Connections menu
The connections menu is used to obtain the connection status of all of the system’s devices.
In particular, the camera head, the light source, the insuator, the PC Panel and the Surgical Monitor.
Note: The icon for this menu changes to orange when at least one of the products on the system is
disconnected.