Comeg Sopro 184 User manual

INTUITIVE

CONNECTION

User manual

Manuel d’utilisation

Manual de usuario

Manuale per utilizzatore

Betriebsanleitung

SOPRO 184

L1 S1 C3 L2 S2

C1 S9 F1 C2 C3 C4 C5 C6 C7 C8 C9 I

CAPTEUR DROIT

S6S4S7

User manual 5

Manuel d’utilisation 29

Manual de usuario 53

Manuale per utilizzatore 77

Betriebsanleitung 101

English

ENGLISH

6011546C6

ENGLISH

7011546C

1Foreword 8

2Presentation of the video camera 9

3Safety instructions 10

4Notice required by law 11

5Installation of the video camera 12

6Connecting the endoscope 13

7Operation in automatic mode 14

8Operation in manual mode 16

9Description of the back panel 18

10 Procedure for disinfecting the sensor 19

11 Aer-sales service 20

12 Troubleshooting 21

13 Technical characteristics 22

14 Electromagnetic compatibility 23

15 Symbols 27

Contents

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1Foreword

Thank you for the trust you have shown in us by acquiring this device.

To derive maximum beneﬁt from it whilst also taking all the requisite precautions, you must read this

manual.

Sentences deaturing the symbol are points that require special attention.

Sentences deaturing the symbol provide information.

To facilitate the installation and use of the video camera, we have done our best to make the manual for

it more practical. Consequently, cross-references to the presentation page on the back of the cover ([D1]

etc.) are oﬀered so you can view the parts of the product concerned more easily.

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2Presentation of the video

camera

The device in question is a fully DIGITAL colour CCD mono video with remote electronics.

Its ergonomic compact sensor, its automatic shutter, and its sensitivity and excellent resolution, as well as

its outstanding colour rendering, make it an ideal medical tool for rigid or ﬂexible endoscopy.

This video camera includes:

• A control channel unit,

• A mains cable,

• A BNC video cable (composite),

• A Y/C video cable,

• An RGB video cable,

• A USB2 cable,

• A BNC video cable (if there is an SDI option),

• A stereo jack cable (for controlling peripherals),

• A user manual,

• 1 CD

Optional items:

• A 1/4” CCD straight sensor with a C mount and featuring programmable buttons, along with a 3m cable

and a connector for the control channel unit and its airtight plug.

• A lens with a focal length of 18 mm, a C mount, with a ring for holding an endoscope.

• 2 SDI outlets.

For the United States and Canada, use the Hospital Grade cord and the connector

that must be ﬁtted with a Hospital Grade mains plug.

Federal law restricts this device to sale by or on the order of a doctor.

This equipment will be delivered to you in a carton or a suitcase, which should be kept should you

need to transport this equipment.

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3Safety instructions

Read the user’s manual

• Follow the storage and user conditions;

• Do not expose the device to excessively dusty conditions;

• The device should only be opened by a skilled technician authorised by the manufacturer;

• To avoid any risks of electric shock, ﬁre, short-circuiting or hazardous emissions, do not insert any metal

objects into the device;

• Do not splash water onto the device or leave it in a location that is too humid;

• Only use the accessories provided with the device or oﬀered on an optional basis by the manufacturer;

• This video camera is not a ﬂamemable device. Consequently, it must not be used in the vicinity of

inﬂammable anaesthetics.

• This device was not designed for use in an ionising environment.

• This device is not sterile.

• The video camera’s surface temperature can reach 41°C (aer a few minutes of use). Consequently,

avoid any contact with this area.

To avoid any risk of electric shock, this device should only be connected to a power supply network

with earthing protection.

Devices connected to the inputs/outputs must comply with the IEC 60950-1 standard.

It is prohibited to modify this device without the manufacturer’s authorisation. If the medical device

is modiﬁed, an inspection and a test must be carried out in order to make sure that the medical device

complies with the safety instructions.

Check the compatibility of your endoscope with the manufacturer, along with your light source, and

do so prior to any use.

It is recommended that you have a second surgical video camera available in the operating unit so

that work can be done should there be a failure, or should a deterioration in performance levels be

observed.

This device must only be used on individuals (patients) ﬁt for undergoing an endoscopy procedure.

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4Notice required by law

4.1 Compliance

This product was designed and manufactured by a company with a certiﬁed quality system.

It fulﬁls the requirements of European Directive 93/42/EEC, relating to medical devices.

Consequently, in particular it complies with electrical safety standards (IEC) and ad hoc ElectroMagnetic

Compatibility (EMC) standards.

4.2Electromagnetic interferencesand electrostaticdischarge

Although this product does comply with EMC standards, it is possible under very special circumstances

that it may disrupt other devices, or that it may itself be disrupted by other devices or an unfavourable

electromagnetic environment.

In order to avoid these situations, the following are recommended:

• Ensuring the quality of the electrical network (and particularly the earthing of all the devices and

carriages)

• Keeping the device away from electromagnetic sources (for example the compressor, motor, transformer,

HF generator, etc.).

4.3 Medical device vigilance

As is the case with any medical device, this device is subject to the provisions relating to medical device

vigilance; any serious malfunction must therefore be reported to the competent authorities and to the

manufacturer as soon as possible, and as accurately as possible.

For the manufacturer’s contact details, refer to the last page of the manual.

4.4 End of lifecycle

This device bears the recycling symbol, in accordance with European Directive 2002/96/EEC

concerning Waste Electrical and Electronic Equipment (WEEE).

By disposing properly of this device, you will contribute to preventing any harmful consequences for the

environment and human health.

The symbol on the device or on the documentation accompanying it indicates that this product may

not be treated like household waste under any circumstances. Consequently, it must be disposed of at a

waste collection center responsible for recycling electrical and electronic equipment waste.

For disposal purposes, comply with the standards relating to disposing of waste in force in the country

where the device is installed. To obtain more details about the topic of treatment, recovery and recycling

of this device, please contact the competent oﬃce in your borough, the waste collection company, or

contact your retailer directly.

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5Installation of the video

camera

This medical device is intended for use by a qualiﬁed surgeon as part of endoscopic explorations.

Installing it does not require any special training. Please refer to the instructions in this manual. Place the

communication channel on a stable support and take its various accessories.

• Connect the power supply cord to the video camera’s mains socket [C2].

• Connect a video cable to one of the video outputs: Preferably, use the Y/C output [C8], the SDI output

[C3 & C4], or the RGB output [C7], which provide a better result than the composite output [C9].

• Connect the second end of the video cable to the monitor’s video input.

Connect the video camera’s USB2 output [C5] to the computer’s USB2 input.

• Place the switch [S9] in position 1. This will place the video camera in stand-by mode (the green

indicator [L1] should then ﬂash).

• Hook up the sensor connector to the front panel of the control channel unit [C3].

• Power up the monitor.

• Press the button [S1] to start up the video camera (the green indicator will light up continuously).

Pressing it once more will return it to stand-by position.

• An image will appear on the monitor and a driver installation message will appear on the computer;

when it does, select the driver delivered with the video camera.

It is prohibited to carry out a surgical operation with the USB2 output; a video output must be

connected to the monitor.

Only the EMPIA2820 driver should be installed for the video camera’s USB2 output. (The driver is

available with the CD delivered.)

Then it will be possible to check that the video camera is operating properly and in particular to make

sure that the monitor’s settings are completely satisfactory: when you disconnect the sensor, a bar test

pattern will appear (except on the USB outlet [C5]).

Before ﬁtting an endoscope (or a ﬁbrescope) to the front of the camera lens, you should check the

condition of the endoscope in question (check that the distal lens or eye-piece is clean).

The functions can be accessed using a single adjustment wheel [S2]. Turning the wheel allows you to

browse through the Menu and pressing on the wheel enables you to validate an item.

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6Connecting the

endoscope

6.1 With the straight sensor

Bring the pegs [S6] on the ring [R1] together and then insert the endoscope.

Once the endoscope is inserted, release the two pegs.

If the sensor’s position has to be locked in relation to the endoscope, you should push the pegs apart until

there is a clicking sound.

Then all you have to do is bring the pegs together in order to unlock the position of the video camera.

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7Operation in automatic

mode

This video camera is equipped with an automatic mode for adjusting the video parameters. In just two

steps, the video camera will be operational. This mode is activated by default.

7.1 Selection of the type of endoscope

Select the rigid endoscope (endoscope with diameters of 1.9 to 10 mm ﬁtted with lenses) or the ﬂexible

endoscope (endoscope ﬁtted with ﬁbre optics) in the Optics tab on the screen [L2] by pressing on the

wheel [S2].

7.2 Focusing

Use the wheel [S4] on the sensor to carry out the focusing.

Once the endoscope is connected and the source is activated, turn the wheel slowly in order to ﬁnd a

position where the objects observed are in sharp focus.

Carrying out focusing quite far away enables you to obtain suﬃcient ﬁeld depth for the operation,

which does away with the need to regularly carry out focusing adjustments.

7.3 White balance

There are two ways of initiating the white balance.

1. From the control channel unit, by pressing the wheel when the AWB white balance icon is selected.

2. From the button [S7] from the straight sensor.

You should carry out the following steps:

• Once the video camera is connected to the endoscope, the ambient light is reduced to a minimum, and

the light source is active, ﬁlm a white surface.

• Activate the white balance; the message “Balance In Progress” will appear on the OLED screen of the

control channel unit, or 4 white squares will appear on-screen.

• Continue to ﬁlm the white surface until the “Balance In Progress” message on the OLED screen of the

control channel unit disappears, or until the 4 white squares disappear.

• At the end of the white balance process, a square matching the size of the endoscope used will appear

on-screen; this deﬁnes the exposure window calculated by the video camera.

If you use one of the buttons on the head of the video camera, keep the button pressed until the

“Balance In Progress” message is obtained and then release it; this time delay will avoid unintentional

pressing on the button.

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7Operation in automatic

mode

7.4 Tools menu

Depending on whether you have selected Auto or Manual mode, the contents of the Tool menu

will diﬀer.

Select the Tool tab on the screen [L2] in order to gain access to the following Menu:

• Languages: EN: English; FR: French; DE: German; ES: Spanish; IT: Italian.

• Up/Down key: Programming the functions that can be activated from the head of the video camera. In

automatic mode, the bottom button [S7] is always programmed for carrying out the white balance

(AWB). It is le to the user to choose one of the following options for parameterisation of the top button:

endoscope, peripherals, mirror, no action.

An “M” will be displayed on the monitor in order to indicate that the Mirror mode has been activated

and it will disappear when this mode is deactivated.

• Blue shi: Shi in the white colorimetry towards the blue end of the scale.

• Red shi: Shi in the white colorimetry towards the red end of the scale.

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8Operation in manual

mode

8.1 Selecting the manual mode

Select the Mode tab and choose “Manual”.

From the list, select the type of endoscope used:

• Rigid 1.9 mm

• Rigid 2.7 mm

• Rigid 4 mm

• Rigid 5 mm

• Rigid 10 mm

• Semi-Rigid

• Flexible

• User’s choice

8.2 White balancing

There are two ways of initiating the white balance.

1. From the control channel unit, by pressing the wheel when the AWB white balance icon is selected.

2. From the button [S7] from the straight sensor.

You should carry out the following steps:

• Once the video camera is connected to the endoscope, the ambient light is reduced to a minimum,and