Logic HD and 4K Camera Control Unit Instructions for Use V10.0 April 2018

Important general instructions and notes for use Make sure that the product is only used as intended by adequately trained and qualified medical personnel following the instruction manual Maintenance and repair must be carried out by authorized experts. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned appli­ cation and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the product in accordance with the manual before every use and before return shipment to protect the pa­ tient, user and third parties. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately on receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing developments the illustrations and technical data may deviate slightly.

Safety instructions and levels of danger Symbols

Level of danger

WARNING!

Failure to observe can result in death or serious injury.

CAUTION!

Failure to observe can result in slight injury or damage to the product.

.

IMPORTANT!

.

NOTE!

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Failure to observe can result in damage to the product or surroundings. Tips for optimum use and other useful information. GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300 MANUFACTURER [email protected] www.richard-wolf.com

USA RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Toll Free: 001 (800) 323 - 9653 Phone: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 [email protected] www.richardwolfusa.com

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: + 44 20 89 44 74 47 Telefax: + 44 20 89 44 13 11 [email protected] www.richardwolf.uk.com

BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent Drongen Telephone: +32 92 80 81 00 Telefax: +32 92 82 92 16 [email protected] www.richard-wolf.be

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F-51100 Reims Telephone: +33 3 26 87 02 89 Telefax: +33 3 26 87 60 33

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A-1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

[email protected]

[email protected] www.richard-wolf.com

Marketing Office U.A.E RICHARD WOLF Middle East P.O. Box 500283 AL Thuraya Tower 1 9th Floor, Room 904, Dubai Telephone: + 9 71 43 68 19 20 Telefax: + 9 71 43 68 61 12 [email protected] www.richard-wolf.com

INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Behind 32nd Milestone Gurgaon - 122 001 National Capitol Region Telephone: + 91 12 44 31 57 00 Telefax: + 91 12 44 31 57 05 [email protected] www.richard-wolf.com

0

Contents 1 1.1 1.2 1.3 1.3.1 1.4 1.5 1.5.1 1.5.2 1.6 1.6.1 1.7 1.7.1 1.7.2 1.8 1.9 1.10

General information... 1 Symbols... 1 Symbols on handheld remote control (option)... 2 Intended use... 3 Performance characteristics... 3 Indications and field of use... 3 Contraindications and side effects... 4 Contraindications... 4 Side effects... 4 License agreements... 4 AVC Patent Portfolio License... 4 Combinations... 5 Equipotentality... 6 Requirements for the products / components of a combination... 7 Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2007... 8 Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014... 10 Connection diagram - Camera Controller in video mode... 12

2 2.1 2.2 2.3 2.4

Illustration... Front view - Camera Controller for all models... Rear view - Logic HD Camera Controller 552510x... Rear view - Logic 4K Camera Controller 5525301... Illustration of handheld remote control unit (option)...

13 13 14 15 16

3 3.1 3.2 3.3 3.4 3.5 3.6 3.7

Setup... Connection to the core nova system... Preparation... Selecting the menu language... Setting the keyboard layout... Setting date and time... Color bar test chart... Adjusting LCD monitors...

17 19 19 20 20 20 21 21

4 4.1 4.2

Checks... 22 Visual check... 22 Function check... 22

5 5.1 5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6 5.2.7 5.3 5.4

Application... Operation... Control elements and operating modes... "Dialog" function... Special Imaging Mode (SIM)... Automatic brightness control (ELC)... Temperature protection circuit... Menu control via touchscreen... Menu control via monitor with handheld remote control (option)... Menu control via monitor with PC keyboard (option)... Menu levels... Menu control via monitor with handheld remote control or PC keyboard...

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23 23 24 24 24 27 27 28 28 28 29 29

I

5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.4.6 5.4.7 5.4.8 5.4.9 5.5 5.6 5.6.1 5.6.2 5.6.3 5.7 5.7.1 5.7.2 5.7.3 5.7.4 5.7.5 5.7.6 5.7.7 5.7.8 5.7.9 5.7.10 5.7.11 5.8 5.8.1 5.8.2 5.8.3 5.8.4

Overview - menu structure - "operation" main menu... Overview - menu structure - "Settings" main menu... Overview - menu structure - "Image archive" menu... Description of the "Settings" submenus... Patient Data Input... Status display for camera head button actions... Symbols and display in the status line at the lower edge of the sceen... On-screen display of blue light mode... Display of function key assignment... Archiving with PIP camera controller (Option)... Menu control via touchscreen functions on device... Overview - menu structure... Touchscreen menus... Description of "Menu" on touchscreen... Operation of camera controller... General notes on the operation within the core nova system... Automatic white balance (AWB)... Displaying and editing... Image brightness... Detail... Electronic zoom... Measurement window (endoscopic image adaptation)... Image flip (mirror image)... Connecting the USB storage medium... USB printer... Taking out of service... Overview of system messages... Structure of system messages... Message types... Functionality of control elements... Operating messages (green)...

29 30 31 32 33 33 34 35 35 36 37 37 38 40 41 41 42 43 43 43 43 43 44 44 44 44 45 45 45 45 46

6 6.1 6.2 6.3

Operation in the core nova system... Operation in the core nova system... Combining and controlling the device... Connection to the core nova system...

49 49 49 50

7 7.1 7.2 7.3 7.3.1

Reprocessing and maintenance... Reprocessing of device... Reprocessing of camera head... Maintenance... Maintenance intervals...

51 51 51 51 51

8 8.1 8.1.1 8.1.2 8.1.3 8.1.4 8.2

Technical description... Troubleshooting... Device error... Fault in video mode... Error in the core nova system... Displays on the monitor... Technical Data...

52 52 52 53 54 55 56

II

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Contents 8.2.1 8.2.2 8.2.3 8.3 8.4 8.5 8.5.1 8.5.2

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Camera controller extension options... Input interfaces... Output interfaces... Operating, storage, transport and shipping conditions... Spare parts and accessories... Replacing parts... Device fuses... Disposal of product, packaging material and accessories...

57 57 58 59 60 61 61 61

III

1

General information

1.1

Symbols Designation

Symbols

Attention, Caution Follow the instruction manual OFF (no power supply, separation from mains) On (power: connection to the power/mains) Equipotentality Fuse Alternating current (AC)

μ

TYPE CF APPLIED PART Camera head connector USB interface Data input Data output Network, LAN (Ethernet) interface Manufacturer Manufacturing date -25_C

Maximum temperature range for shipment, transport and storage

+ 50_C

XX° XX°

Permissible temperature range

XXhPa

Permissible atmospheric pressure range XXhPa XX%

Permissible humidity range XX%

Recycle the product separately. Do not discard together with other waste. A Registered Trademark of a Recognized Testing Laboratory, confirm the compliance to the standard of Medical Electrical Equipment CAN/CSA C22.2 No.601­1 (c) and UL60601­1 (us)

1

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Symbols

Designation A Registered Trademark of a Recognized Testing Laboratory, confirm the compliance to the standard of Medical Electrical Equipment CAN/CSA C22.2 No.60601-1 (c) and ANSI/AAMI ES60601-1 (us) Identification in conformity with medical devices directive 93/42/EEC only valid if the product and/or packaging is marked with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally identified with the code no. of the notified body (0124).

1.2

Symbols on handheld remote control (option) Symbols

Designation "Escape" or "back" “Up"

"left" or "minus"

"right" or "plus"

"down" OK button for confirmation Function key I Function key II

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2

1.3

Intended use The products Logic HD Camera Controller 552510x and Logic 4K Cam­ era Controller 5525301 are used for visualizing natural or artificially cre­ ated hollow spaces through images generated by a rigid or flexible endo­ scope via natural or surgically created passages within the scope of diagnostic or therapeutic medical endoscopy. The Camera Controller is equipped with different output connectors (USB, video, S-video, etc.) to which USB storage media, image storage devices and other video devices for recording and storing video images and video sequences can be connected. This product is designed exclusively for use by specialized medical per­ sonnel and may only be applied by medically qualified and adequately trained persons.

1.3.1

Performance characteristics - Image recording. - Signal processing of the image data.

1.4

Indications and field of use This product is used for diagnosis and therapy in conjunction with endo­ scopic accessories. On the basis of the patient’s general condition, the user in charge must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical literature.

CAUTION! The device may fail! For therapeutic applications, a second camera with the same specifica­ tions should be available.

.

3

NOTE! We recommend reading relevant literature for the planned application.

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1.5

Contraindications and side effects

1.5.1

Contraindications Contraindications directly related to the product are presently unknown. On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical litera­ ture.

1.5.2

Side effects

1.6

License agreements

Side effects directly related to the product are currently unknown.

This product contains open-source software from other suppliers which are subject to the GNU license agreements GPL (GNU General Public License), LGPL (GNU Library/Lesser General Public License) and/or Apache license agreements. The license texts of the GPL, LGPL and Apache license as well as the source code of the corresponding software components are available on the storage medium accompanying the device. Please read the precise wording to be informed about your rights relating to the aforementioned licenses. 1.6.1

AVC Patent Portfolio License THIS PRODUCT IS LICENSED UNDER THE AVC PATENT PORTFO­ LIO LICENSE FOR THE PERSONAL USE OF A CONSUMER OR OTHER USES IN WHICH IT DOES NOT RECEIVE REMUNERATION TO (i) ENCODE VIDEO IN COMPLIANCE WITH THE AVC STANDARD ("AVC VIDEO") AND/OR (ii) DECODE AVC VIDEO THAT WAS EN­ CODED BY A CONSUMER ENGAGED IN A PERSONAL ACTIVITY AND/OR WAS OBTAINED FROM A VIDEO PROVIDER LICENSED TO PROVIDE AVC VIDEO. NO LICENSE IS GRANTED OR SHALL BE IM­ PLIED FOR ANY OTHER USE. ADDITIONAL INFORMATION MAY BE OBTAINED FROM MPEG LA, L.L.C. SEE HTTP://WWW.MPEGLA.COM

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4

1.7

Combinations Logic HD Camera Controller 552510x and Logic 4K Camera Controller 5525301 must only be used in combination with the camera heads and sensor endoscopes approved by Richard Wolf and following the corre­ sponding instruction manual. From software version R19 (>1.3.x), Logic HD Camera Controller 552510X and Logic 4K Camera Controller 5525301 feature white light, blue light and special modes in Special Imaging Mode SIM. In blue light mode, blue light applications are possible in combination with system components suitable for PDD fluorescence diagnostics. In white light mode, the white light special modes (e.g. HDR) are only possible in combination with suitable system components. The device automatically detects whether suitable system components for the corresponding application are connected and only if so, the corre­ sponding mode can be activated.

5

.

IMPORTANT! For operation in blue light mode please observe instruction manual GAA324 for the blue system.

.

IMPORTANT! Connect only USB accessories tested and approved by Richard Wolf to the USB interfaces. Otherwise interference or malfunction cannot be ex­ cluded.

.

IMPORTANT! The installation of the entire product including the configuration setting via the core nova system must be carried out by an authorized and trained expert.

.

IMPORTANT! Do not connect the device to other networks, such as the hospital inhouse network via the LAN (Ethernet) interface. The device may only be connected within the core nova system via the LAN (Ethernet) interface.

.

IMPORTANT! In addition to this manual follow the latest manuals of the products used in combination with this product. Only components approved for the core nova system may be connected. For further information please contact Richard Wolf or your representa­ tive.

.

IMPORTANT! The OR network must be galvanically isolated from the hospital network, e.g. by: - optical network cables with the corresponding optical transceiver for the network switch. - a network isolator for medical devices.

.

IMPORTANT! Close any LAN (Ethernet) sockets in the network switch that are not used with the corresponding plastic caps.

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1.7.1

Equipotentality

The potential equalization cable represents a direct connection between a medical electrical device and a potential equlization rail. It serves to equalize differences in potential between enclosures of elec­ trical equipment and firmly installed conductive parts in the patient envi­ ronment.

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1.7.2

Requirements for the products / components of a combination 1.5m

1.5m The general requirements depend on whether the products / com­ ponents are inside or outside the patient environment.

1.5m

IEC 60601-1, 3. Ed.

Medically used room inside the patient environment MP

MP

~

~

MP

MP

outside the patient environment

Non-medically used room

-

-

Requirements / measures Leakage currents to section 16.6 IEC 60601-1:2005 / EN 60601-1:2006 *

Verification of the total patient leakage current

~ ** NMP

MP

~* *

~

NMP

MP

-

Verification of leakage currents

~ ** MP

a) additional protective earth connection (consult the corresponding manufacturer),

-

or b) additional isolating transformer for medical applications **

NMP

~ MP

NMP

~ MP / NMP

MP

~ ** MP

NMP

~

~

MP

MP / NMP

~

~

additional "isolating transformer" to IEC/ EN60601-1 ** Functional connection MP NMP

Verification of leakage currents a) no plugs with metal housing, or b) additional isolation device (to avoid voltage differentials)

-

~

Verification of leakage currents a) common protective earth connection, or b) additional protective earth connection at MP (clarify with the corre­ ponding manufacturer), or c) additional isolation device (to avoid voltage differentials), or d) no plugs with metal housing in the patient environment

additional isolating device to IEC/ EN 60601-1

Multiple socket strip

Power supply grid

= medical electrical device to IEC/ EN 60601-1, ANSI/AAMI es60601-1, CSA C22.2 No. 60601-1 = non-medical electrical device in accordance with product-specific IEC/EN/UL standards

* **

When connected via the same multiple socket strip under standard conditions, the earth leakage current of the socket strip must not exceed 5 mA. e.g. Richard Wolf video cart with "isolating transformer"

Only connect devices with a safety extra-low voltage of no more than 60 V DC / 42.4 V AC peak to the connectors for electrical connections, i.e. the signal inputs and outputs.

7

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.

1.8

IMPORTANT! Persons combining products to form a system are responsible for not impairing the system's compliance with perfor­ mance and safety requirements, and that the technical data and the intended use are adequately fulfilled. Possible electromagnetic or other interference that may occur between the product and other products can cause faults or malfunctions. When selecting the system components, make sure that they meet the necessary requirements of the medical envi­ ronment they are used in, in particular IEC/ EN 60601-1. In case of doubt contact the manufacturer(s) of the system components. Do not touch connectors for electrical connections between various components (such as signal input connectors and signal output connectors for video signals, data exchange, controls etc.) and the patient at the same time.

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2007

Please observe the following: The device/system, in the following referred to as product, always relates to Logic HD Camera Controller 552510x and Logic 4K Camera Controller 5525301.

Guidelines and manufacturer's declaration - Electromagnetic emissions The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Emissions measurement / test

Compliance

Electromagnetic environment - Guidelines

HF emissions to CISPR 11

Group 1

The product uses HF energy for its internal function. The HF emission level is extremely low and is not likely to cause any interference in nearby electronic equipment.

HF emissions to CISPR 11

Class A

Harmonic emissions to IEC 61000-3-2

Class A

In conformity with IEC 61000-3-3 “Emission of voltage fluctuations / flicker"

The product is suitable for use in buildings other than residential buildings and buildings that are immediately connected to the public power supply network that also supplies buildings used for residential purposes pro­ vided the following warning is observed: Warning: The product is only intended for use by specialized medical staff. This product can cause radio interference which may make it neces­ sary to take suitable remedial measures such as new alignment, new positioning or screening of the product or a filter in the connection to the installation site.

Guidelines and manufacturer's declaration - Electromagnetic immunity The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Electrostatic discharge (ESD) to IEC 61000-4-2

 6 KV contact discharge  8 KV air discharge

Yes

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the rela­ tive humidity should be at least 30%.

Electrical fast transience, bursts to IEC 61000-4-4

 2 KV for power supply lines  1 KV for input and output lines

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

Surge voltage (surges) to IEC 61000-4-5

 1 KV line to line voltage  2 KV line to ground voltage

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and sup­ ply voltage variations to IEC 61000-4-11

Voltage dip for 0.5 cycle > 95% UT * Voltage dip for 5 cycles 60% UT * Voltage dip for 25 cycles 30% UT * Voltage dip for 5 sec > 95% UT *

Yes

Mains/line power quality should be that of a typical commercial or hospital environment. If the user of the product requires continued operation during power mains/line interruptions it is recommended that the product be powered from an uninterrupt­ ible power supply or battery.

Power frequency (50/60 Hz) magnetic field, to IEC 61000-4-8

3A/m

Yes

Power frequency magnetic fields should be at lev­ els characteristic of a typical location in a commer­ cial or hospital environment.

Compliance

Electromagnetic environment - Guidelines

* NOTE! UT is the line / mains voltage prior to application of the test level.

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8

Guidelines and manufacturer's declaration - Electromagnetic immunity for products that are not life-supporting The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Compliance

Electromagnetic environment - Guidelines Portable and mobile RF communications equipment should be used no closer to any part of the product, including ca­ bles, than the recommended separation distance calculated from the equation applicable to the frequency of the transmit­ ter. Recommended separation distance: d = 1.2 p P

Conducted HF interference to IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

Radiated HF interference to IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

d = 1.2 p P for 80 MHz to 800 MHz Yes

d = 2.3 p P for 800 MHz to 2.5 GHz P = Nominal power output rating of the transmitter in watts (W) (according to the transmitter manufacturer)

d = recommended separation distance in meters (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey1, should be less than the compliance level in each frequency range2. Interference may occur in the vicinity of devices with the following symbol:

REMARKS: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of electromag­ netic waves is affected by absorption and reflexion from buildings, objects and people. 1 = The field strength of stationary transmitters (e.g. base station for radio phone, earth to earth radio stations,, amateur radio stations, radio and television transmitters) cannot be exactly predicted in theory. To assess the EMC environment due to fixed transmitters an electromagnetic site survey should be conducted. If the measured field strength in the location in which the product is used exceeds the applicable compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product. 2 = Over the frequency range between 150 kHz and 80 MHz the field strength should be below 3 V/m.

Recommended separation distances between portable and mobile HF telecommunication devices and devices which are not life-supporting The product is intended for use in an electromagnetic environment where HF disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunica­ tions equipment and the product. Rated nominal output power of thetransmitter (W)

Separation distance as a function of transmitter frequency (m) 150 kHz to 80 MHz d = 1.2 p P

80 MHz to 800 MHz d = 1.2 p P

800 MHz to 2.5 GHz d = 2.3 p 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 nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can be determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watts (W). REMARKS: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of electromag­ netic waves is affected by absorption and reflexion from buildings, objects and people.

9

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1.9

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014

Please observe the following: The device/system, in the following referred to as product, always relates to Logic HD Camera Controller 552510x and Logic 4K Camera Controller 5525301.

Guidelines and manufacturer's declaration - Electromagnetic emissions The product is intended for use in the environment specified below. The user must make sure that the product is used in such an environment. Emissions measurement / test

Compliance

Electromagnetic environment - Guidelines

HF emissions to CISPR 11

Group 1

The product uses HF energy for its internal function. The HF emission level is extremely low and is not likely to cause any interference in nearby electronic equipment.

HF emissions to CISPR 11

Class A

Harmonic emissions to IEC 61000-3-2

Class A

In conformity with IEC 61000-3-3 “Emission of voltage fluctuations / flicker"

The product is suitable for use in buildings other than residential buildings and buildings that are immediately connected to the public power supply network that also supplies buildings used for residential purposes pro­ vided the following warning is observed: Warning: The product is only intended for use by specialized medical staff. This product can cause radio interference which may make it neces­ sary to take suitable remedial measures such as new alignment, new positioning or screening of the product or a filter in the connection to the installation site.

Guidelines and manufacturer's declaration - Electromagnetic immunity The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Electrostatic discharge (ESD) to IEC 61000-4-2

 8 KV contact discharge  15 KV air discharge

Yes

Floors should be wood, concrete or ceramic tile. With floors made of synthetic material, the relative humidity of the ambient air must be at least 30%.

Electrical fast transience, bursts to IEC 61000-4-4

 2 KV for power supply lines  1 KV for input and output lines

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

Surge voltage (surges) to IEC 61000-4-5

 1 KV line to line voltage  2 KV line to ground voltage

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and sup­ ply voltage variations to IEC 61000-4-11

0% UT * ; 1/2 period at 0.45, 90, 135, 180, 225, 270 and 315 degrees 0% UT * ; 1 Period and 70% UT * ; 25/30 Periods single-phase: at 0 degrees

Yes

Mains/line power quality should be that of a typical commercial or hospital environment. If the user of the product requires continued operation during power mains/line interruptions it is recommended that the product be powered from an uninterrupt­ ible power supply or battery.

Power frequency (50/60 Hz) magnetic field, to IEC 61000-4-8

30A/m

Yes

Power frequency magnetic fields should be at lev­ els characteristic of a typical location in a commer­ cial or hospital environment.

Compliance

Electromagnetic environment - Guidelines

* NOTE! UT is the line / mains voltage prior to application of the test level.

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10

Guidelines and manufacturer's declaration - Electromagnetic immunity for products that are not life-supporting The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Compliance

Electromagnetic environment - Guidelines Portable and mobile RF communications equipment should be used no closer to any part of the product, including ca­ bles, than the recommended separation distance calculated from the equation applicable to the frequency of the transmit­ ter. Recommended separation distance: d = 1.2 p P d = 1.2 p P for 80 MHz to 800 MHz

Conducted HF interference to IEC 61000-4-6

6 Vrms 150 kHz to 80 MHz

Yes

Radiated HF interference to IEC 61000-4-3

3 V/m 80 MHz to 2.7 GHz

Yes

d = 2.3 p P for 800 MHz to 2.5 GHz P = Nominal power output rating of the transmitter in watts (W) (according to the transmitter manufacturer)

d = recommended separation distance in meters (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey1, should be less than the compliance level in each frequency range2. Interference may occur in the vicinity of devices with the following symbol:

REMARKS: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of electromag­ netic waves is affected by absorption and reflexion from buildings, objects and people. 1 = The field strength of stationary transmitters (e.g. base station for radio phone, earth to earth radio stations,, amateur radio stations, radio and television transmitters) cannot be exactly predicted in theory. To assess the EMC environment due to fixed transmitters an electromagnetic site survey should be conducted. If the measured field strength in the location in which the product is used exceeds the applicable compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product. 2 = Over the frequency range between 150 kHz and 80 MHz the field strength should be below 3 V/m.

Recommended separation distances between portable and mobile HF telecommunication devices and devices which are not life-supporting The product is intended for use in an electromagnetic environment where HF disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunica­ tions equipment and the product. Rated nominal output power of thetransmitter (W)

Separation distance as a function of transmitter frequency (m) 150 kHz to 80 MHz d = 1.2 p P

80 MHz to 800 MHz d = 1.2 p P

800 MHz to 2.5 GHz d = 2.3 p 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 nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can be determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watts (W). REMARKS: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of electromag­ netic waves is affected by absorption and reflexion from buildings, objects and people.

11

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1.10

Connection diagram - Camera Controller in video mode

1

2

3

3

3

Legend Direct connection 1

LAN (Ethernet) connection cable (option) - core nova System

2

Video cables in accordance with the signal types of the Camera Controller used Connection via recording devices

3

.

Video cables in accordance with signal types of the Camera Controller and recording devices used

IMPORTANT! Connection of the LAN (Ethernet) connection cable (1) only in the case of an interactive light source.

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2

Illustration

2.1

Front view - Camera Controller for all models

4

3

2

1.1

1

Legend 1

Power/mains switch

3

Camera socket (type CF applied part)

1.1

Power ON/OFF LED

4

USB 2.0 interface (for external storage media)

2

Touch-screen

13

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2.2

Rear view - Logic HD Camera Controller 552510x 11

12

13

14

15

REMOTE

VIDEO

DC OUT

SDI HD- SDI

3G- SDI

3G- SDI

S- VIDEO

LAN

10

9

8

HDMI HD

7

5

6

16 FEDERAL LAW RESTRICTS THIS UNIT TO BE USED OR SOLD, EXCEPT UNDER THE SUPERVISION OF A MEDICAL DOCTOR.

Legend 5 6

HDMI HD output USB 2.0 port

11 12

7 8 9 10

LAN (Ethernet) network connector Equipotential connector Power input connector with fuse holder Fuse label

13 14 15 16

GA-A282

Power supply 5V DC, 12V DC Remote output connectors (e.g. printer remote control) PIP module (option) HD-SDI module (option) SD-Video module (option) Identification plate

14

2.3

Rear view - Logic 4K Camera Controller 5525301 11

12

13

14

15

REMOTE DC OUT

SDI HD- SDI

3G- SDI

HDMI 4K

3G- SDI

LAN

10

9

8

HDMI HD

7

5

6

16 FEDERAL LAW RESTRICTS THIS UNIT TO BE USED OR SOLD, EXCEPT UNDER THE SUPERVISION OF A MEDICAL DOCTOR.

Legend 5 6

HDMI HD output USB 2.0 port

11 12

7 8 9 10

LAN (Ethernet) network connector Equipotential connector Power input connector with fuse holder Fuse label

13 14 15 16

15

Power supply 5V DC, 12V DC Remote output connectors (e.g. printer remote control) PIP module HD-SDI module HDMI 4K module Identification plate

GA-A282