core.media 5593001 Instruction Manual V2.0 May 2014

Important general notes and instructions Make sure that this product is used only as intended and described in this instruction manual and by adequately trained and qualified medical personnel, 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. Immediately upon 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 Symbol

Level of danger

WARNING!

Failure to observe can result in death or extremely serious injuries.

CAUTION!

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

IMPORTANT!

Failure to observe can result in damage to the product or surroundings.

NOTE!

User tips for optimum device use and other useful information.

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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

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Contents 1 1.1 1.2 1.2.1 1.3 1.4 1.4.1 1.4.2 1.5 1.5.1 1.5.2 1.6 1.7 1.7.1 1.7.2 1.8 1.8.1

General information... Symbol... Intended use... Performance characteristics... Indications and area of application... Contraindications and side effects... Contraindications... Side effects... Combinations... Potential Equalization... Requirements for products / components of a combination... Electromagnetic compatibility (EMC)... License agreements... AVC Patent Portfolio License... Richard Wolf GmbH End User License Agreement (EULA)... Connection diagram... Connection to video sources and monitors...

1 1 2 2 2 2 2 2 3 3 4 5 7 7 8 9 9

2 2.1 2.2 2.3

Illustration... Front view... Illustration of rear panel... Illustration of video I/O card breakout cable...

10 10 11 12

3 3.1 3.1.1 3.1.2 3.1.3

Setup... Preparations... Connection to the core nova system... Connection of video sources and monitors... Connection of external converters...

13 14 14 14 14

4 4.1 4.2 4.2.1

Checks... Visual check... Function check... Function of system components...

15 15 15 15

5 5.1 5.2 5.2.1 5.3 5.3.1 5.3.2 5.3.3 5.3.4 5.3.5 5.3.6 5.3.7 5.3.8 5.3.9 5.3.10 5.3.11

Use... Operating principle... Control elements and operating modes... Control terminal... Operation of core.media via the core.browser... Symbols on the user interface... Monitors 1 to 4... Recorders 1 and 2... Selection of images and display... Video channels displayed... Status line... Connection to core.portal... Storage of images and videos... Starting the device... Connecting the USB storage medium... Taking out of service...

16 16 16 16 17 17 19 20 20 20 20 21 21 21 21 21

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5.4 5.4.1 5.4.2 5.4.3 5.4.4 5.4.5

Overview of device messages in the core system... Structure of system messages... Message types... Functionality of control elements... MEDIUM error (yellow)... HIGH error (red)...

22 22 22 22 23 23

6 6.1 6.2 6.3

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

24 24 24 25

7 7.1 7.2 7.2.1

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

26 26 26 26

8 8.1 8.1.1 8.1.2 8.2 8.2.1 8.3 8.4 8.4.1

Technical description... Troubleshooting... Device error... Error in core mode... Technical data... Interfaces... Operating, storage, transport and shipping conditions... Spare parts and accessories... Disposal of product, packaging material and accessories...

27 27 27 28 29 29 30 31 31

II

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1

General information

1.1

Symbol Symbol

Designation Attention, Caution Follow the instruction manual On/Off pushbutton Non-ionizing electromagnetic radiation (In the vicinity, electromagnetic interference is possible) Potential Equalization Power / Mains fuse Alternating current (AC)

µ

USB interface Network, LAN (Ethernet) interface Microphone connector Volume control Reset Data memory Data output (EXTERNAL) Manufacturer

REF

Order number DO NOT BLOCK VENTILATION

-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, confirming compliance to the standard of Medical Electrical Equipment CAN/CSA C22.2 No.60601-1 (c c) and ANSI/AAMI ES60601-1 (us us) us Identification in conformity with medical devices directive 93/42/EEC only valid if the product and/or packaging is marked with this symbol. 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).

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1.2

Intended use

The core.media 5593001 device is designed for distributing and recording video signals and video data. The device is equipped with four inputs and outputs for 3G-SDI video sig­ nals, a USB output for USB storage media and a network connector for the connection to a core system. This product is exclusively intended for use by medical experts and may only be used by adequately qualified and trained medical doctors

1.2.1

Performance characteristics - Distribution of video signals and video streams to monitors. - Recording of video signals as video streams and single images.

1.3

Indications and area of application The device can be used both for diagnostic and therapeutic interventions. 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.

IMPORTANT! In addition to this instruction manual, observe the latest manual for the core.browser software. core CAUTION! System components may fail. If the device is used for therapeutic applications, adequate system com­ ponents must be available as a backup.

1.4

Contraindications and side effects

1.4.1

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.

1.4.2

2

Side effects

Side effects directly related to the product are currently unknown.

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1.5

Combinations This product must only be applied in combination with the devices ap­ proved by Richard Wolf and following the corresponding instruction man­ ual.

IMPORTANT! The installation of the entire product, including the configuration settings via the core system, must be carried out by an authorized and trained expert. IMPORTANT! Do not connect the device via the LAN (Ethernet) interface to other net­ works, such as the hospital in-house network. The device may only be connected via the LAN (Ethernet) interface within the core system. 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 system may be connected to the device. For further information please contact Richard Wolf or your repre­ sentative. IMPORTANT! The OR network must be galvanically isolated from the hospital network, e.g. by: - Optical network cables with corresponding optical transceiver for the network switch. - Network isolator for medical devices. IMPORTANT! Close any LAN (Ethernet) sockets in the network switch that are not used with the corresponding plastic caps. IMPORTANT! Connect only USB accessories tested and approved by Richard Wolf to the USB interfaces. Otherwise interference or malfunction cannot be ex­ cluded. 1.5.1

Potential Equalization

The potential equlization cable represents a direct connection between a medical electrical device and a potential equlization rail. It serves to avoid or to equalize differences in potential between enclo­ sures of electrical equipment and firmly installed conductive parts in the patient environment.

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1.5.2

Requirements for 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 sponding 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 a 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 60V DC / 42.4V AC peak to the connectors for electrical connections, i.e. the signal inputs and outputs.

4

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IMPORTANT! The persons combining products to form a system are responsible for not impairing the system's compliance with performance 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 (3. Edition IEC/EN 60601-1, section 16). 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.

1.6

Electromagnetic compatibility (EMC)

Please observe the following: The device, in the following called product, product always relates to the core.media device.

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 it 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. Compliance

Immunity tests

IEC 60601 test level

Electromagnetic environment - Guidelines

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

3 A/m

Yes

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

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

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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:

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

Yes

d = 1.2

P

d = 1.2

P for 80 MHz to 800 MHz

d = 2.3 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. Separation distance as a function of transmitter frequency (m) Rated nominal output power of thetransmitter (W)

150 kHz to 80 MHz d = 1.2 p

d = 1.2

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

80 MHz to 800 MHz P

800 MHz to 2.5 GHz d = 2.3

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

P

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.

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1.7

License agreements

1.7.1

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 ENCO­ DED BY A CONSUMER ENGAGED IN A PERSONAL ACTIVITY AND/ OR WAS OBTAINED FROM A VIDEO PROVIDER LICENSED TO PRO­ VIDE AVC VIDEO. NO LICENSE IS GRANTED OR SHALL BE IMPLIED FOR ANY OTHER USE. ADDITIONAL INFORMATION MAY BE OB­ TAINED FROM MPEG LA, L.L.C. SEE HTTP://WWW.MPEGLA.COM

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1.7.2

Richard Wolf GmbH End User License Agreement (EULA) You have acquired a device that includes software licensed by Richard Wolf GmbH from Microsoft Licensing Inc. or its affili­ ates. Those installed software products of MS origin, as well as associated media, printed materials, and "online” or elec­ tronic documentation are protected by international intellectual property laws and treaties. The MS-SOFTWARE is licensed, not sold. All rights reserved. IF YOU DO NOT AGREE TO THIS END USER LICENSE AGREEMENT (”EULA”), DO NOT USE THE DEVICE OR COPY THE SOFTWARE. INSTEAD, PROMPTLY CONTACT RICHARD WOLF GMBH FOR INSTRUCTIONS ON RETURN OF THE UNUSED DEVICE(S) FOR A REFUND. ANY USE OF THE SOFTWARE, INCLUDING BUT NOT LIMITED TO USE ON THE DEVICE, WILL CONSTITUTE YOUR AGREEMENT TO THIS EULA (OR RATIFICATION OF ANY PREVIOUS CONSENT).

GRANT OF SOFTWARE LICENSE. This EULA grants you the following license: You may use the SOFTWARE only on the DEVICE. It is not allowed to copy the SOFTWARE. SOFTWARE INSTALLATIONS, UPDATES AND USE. Only released and certified core.software versions of the original manufacturer may be installed. In the case of infringement the warranty and the warranty period as well as CE compli­ ance will automatically become void. The user may only execute Richard Wolf GmbH software released for the purpose on the core system. Services and applications which are not started automatically by the core.software must not be executed.

Furthermore, after the initial setup and after any software update, the core system must be subjected to a complete func­ tion test as set forth in the instruction manual. This test must include the testing of all functions of the devices connected to the core system for proper functioning by control via the device controls and by control via the core system.

Modifications of the operating system may only be carried out with the explicit approval of the manufacturer. If the instruction manual is not followed, Richard Wolf GmbH will not assume any responsibility for any resulting damage. NOT FAULT TOLERANT. THE MS-SOFTWARE IS NOT FAULT TOLERANT. RICHARD WOLF GMBH HAS INDEPEN­ DENTLY DETERMINED HOW TO USE THE MS-SOFTWARE IN THE DEVICE, AND MS HAS RELIED UPON RICHARD WOLF GMBH TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE MS-SOFTWARE IS SUITABLE FOR SUCH USE. NO WARRANTIES FOR THE MS-SOFTWARE. THE MS-SOFTWARE IS PROVIDED ”AS IS” AND WITH ALL FAULTS. THE ENTIRE RISK AS TO SATISFACTORY QUALITY PERFORMANCE, ACCURACY AND EFFORT (INCLUDING LACK OF NEGLIGENCE) IS WITH YOU. ALSO, THERE IS NO WARRANTY AGAINST INTERFERENCE WITH YOUR ENJOYMENT OF THE SOFTWARE OR AGAINST INFRINGEMENT. IF YOU HAVE RECEIVED ANY WARRANTIES REGARDING THE DEVICE OR THE SOFTWARE, THOSE WARRANTIES DO NOT ORIGINATE FROM, AND ARE NOT BINDING ON, MS. NOTE ON JAVA SUPPORT. The SOFTWARE may contain support for programs written in Java. Java technology is not fault tolerant and is not designed, manufactured or intended for use or resale as online control equipment in hazardous environments requiring fail-safe performance, such as in the operation of nuclear facilities, aircraft navigation or commu­ nication systems, air traffic control, direct life support machines or weapons systems, in which the failure of Java technol­ ogy could lead directly to death, personal injury, or severe physical or environmental damage. Sun Microsystems, Inc. has contractually obligated MS to make this disclaimer. No Liability for Certain Damages. EXCEPT AS PROHIBITED BY LAW, MS SHALL HAVE NO LIABILITY FOR ANY INDI­ RECT, SPECIAL, CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE MS-SOFTWARE. THIS LIMITATION SHALL APPLY EVEN IF ANY REMEDY FAILS OF ITS ESSENTIAL PURPOSE. IN NO EVENT SHALL MS BE LIABLE FOR ANY AMOUNT IN EXCESS OF U.S. TWO HUNDRED FIFTY DOLLARS (U.S.$250.00). Limitations on Reverse Engineering, Decompilation, and Disassembly. You may not reverse engineer, decompile or disassemble the SOFTWARE, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation. SOFTWARE TRANSFER ALLOWED BUT WITH RESTRICTIONS. You may permanently transfer rights under this EULA only as part of a permanent sale or transfer of the Device, and only if the recipient agrees to this EULA. If the SOFT­ WARE is an upgrade, any transfer must also include all prior versions of the SOFTWARE. EXPORT RESTRICTIONS. RESTRICTIONS You hereby confirm that the MS-SOFtWARE originally comes from the USA. You agree to comply with all applicable interna­ tional and national laws that apply to the MS-SOFTWARE, including the U.S. Export Administration Regulations, as well as end-user, end-use and country destination restrictions issued by U.S. and other governments. For additional information on exporting the MS-SOFTWARE, see http://www.microsoft.com/exporting/.

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1.8

Connection diagram

1.8.1

Connection to video sources and monitors

Camera head

Room Ultrasound Camera

Network switch

IMPORTANT! The device is equipped with 3G-SDI standard video interfaces. When establishing cable connections to peripheral devices, make sure that these standards are met. IMPORTANT! Safety relevant video signals, such as the endoscopic camera, should always also be connected directly to a monitor.

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2

Illustration

2.1

Front view

2

1.1

1

Legend 1

Switch-on pushbutton

1.1

LED „ON“

10

2

USB 2.0 port

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2.2

Illustration of rear panel 13

14

15

16

3 12

11 10

9

8

9

7

6

5

4

17

Legend 3

Power supply connector

11

Connection not used

4

Line In jack, light blue

12

Connections not used

5

Line Out jack, light green (external speaker)

13

Video input C, 3G-SDI video signal

6

Microphone jack, pink

14

Video input D, HD-SDI video signal

7

Potential equalization connector

15

External power supply 5V DC, 12V DC, e.g. external signal converters

8

LAN (Ethernet) network connector

16

Connection for video signal distribution cable

9

Connections not used

17

Identification plate

10

Connection not used

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2.3

Illustration of video I/O card breakout cable

20.1

20

20.2 20.3 20.4 20.5 20.6 20.7 20.8

Legend 20

Video I/O card breakout cable

20.1

Video output D, HD-SDI video signal

20.2

Video output C, HD-SDI video signal

20.3

Video output B, 3G-SDI video signal

20.4

Video input B, 3G­SDI video signal

20.5

Video output A, 3G-SDI video signal

20.6

(Analog REF loop output - connection not used)

20.7

(Analog REF input - connection not used)

20.8

Video input A, 3G-SDI video signal

12

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Setup WARNING! The device is not protected against explosions. Explosion hazard. Do not operate this device in areas where there is a danger of explosion. WARNING! Danger if a power supply without protective earth is used. Danger of electric shock! Connect the device only to a power supply with protective earth connector. IMPORTANT! Do not open the device NOTE! The line/mains voltage and the voltage indicated on the identification plate must be the same. Connect the device only via the supplied power cable or a power cable with the same specifications. IMPORTANT! To fully disconnect the device from the power supply / mains, it is neces­ sary to disconnect the power cable. CAUTION! Danger of faults and malfunctions. To guarantee the safety of the user, patient and others, use only acces­ sories and spare parts as specified by the manufacturer of this product. Other accessories or spare parts can cause the emission of increased electromagnetic radiation or reduced immunity against interference. IMPORTANT! Medical electrical equipment is subject to special precautions with regard to electromagnetic compatibility (EMC EMC). EMC Make sure you follow the notes on EMC for installation and operation. Medical electrical devices can be influenced by mobile HF communication devices. Do not arrange the devices side by side and do not stack the devices. If it is necessary to stack the devices or place them next to each other and HF interference is observed, make sure that the devices are oper­ ated as specified in the intended use.

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CAUTION! The device may fail due to overheating. In the case of insufficient air supply, a warning is issued. There is no au­ tomatic over-temperature cutout. Units with a cooling device [e.g. fan] require a minimum distance of 15 cm from the wall and unobstructed vent slots. Do not cover any openings required for cooling. To prevent a possible accumulation of heat in the closed system cart, place the devices accordingly and/or provide vent slots. NOTE! To prevent liquid from being sucked into the ventilation system, do not place any products or items from liquids can leak onto the device.

3.1

Preparations

3.1.1

Connection to the core nova system The core nova system including all system components may only be con­ nected by an authorized service technician. Observe the connection dia­ grams in sections 1 and 6, as well as the corresponding manuals for the system components.

IMPORTANT! Use only LAN (ethernet) connection cables with a locking tab on the plug. The plug of the LAN (ethernet) connection cable must engage in the LAN (Ethernet) netzwork socket of the device. IMPORTANT! After connecting the devices to the core system, carry out a function test with the devices. 3.1.2

Connection of video sources and monitors Observe the connection diagram in section 1, and the corresponding manuals for the system components.

NOTE! The device is equipped with 3G-SDI standard video interfaces. When es­ tablishing cable connections to peripheral devices, make sure that these standards are met. Signal conversion to 3G-SDI by means of an external converter is possible. IMPORTANT! Safety relevant video signals, such as the endoscopic camera, should always also be connected directly to a monitor. 3.1.3

14

Connection of external converters The device can supply external converters with power.

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Checks IMPORTANT! Run through the checks before and after each use. Do not use the products if they are damaged or incomplete or have loose parts. Return damaged products together with any loose parts for repair. Do not attempt to do any repairs yourself.

4.1

Visual check

Check the device, the instruments and the accessories for damage, loose or missing parts, hygiene and completeness. Check all connection cables for damage. Any inscription, lettering or labeling necessary for the safe intended use must be legible. Missing inscriptions, lettering or labeling leading to wrong handling or reprocessing must be reinstated.

4.2

Function check IMPORTANT! Before you perform the function checks, make sure that the devices are in perfect technical condition and are set up correctly. This must also be guaranteed within the scope of the visual check.

4.2.1

Function of system components Check all system components in accordance with the instruction manual for proper functioning. Check the connected video sources and the monitor for proper functioning. Check that all connected video sources are visible on all monitors.

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5

Use

5.1

Operating principle The core.media device distributes incoming 3G-SDI video signals (4 in­ puts) to a maximum of 4 monitors (4 outputs) for display and recording as single image. In addition, the device encodes up to two video signals (SDI) as H.264 video stream, e.g. for recording in a storage medium or server. A third, additional video stream can be sent from the operating room to a client via the LAN (ethernet) network. In reverse direction, up to two H.264 video streams available in the net­ work can be decoded via the LAN (ethernet) network connector and also be displayed as a video signal via the max. 4 monitors connected. In addition, the incoming video signals can be combined into an image-inimage or Quadsplit view on the display. The device is controlled centrally from a control terminal via the core.browser software. This requires a network connection to a core sys­ tem.

5.2

Control elements and operating modes NOTE! In case of a power failure, the device can pass on the video signal from input A to output A and from input B to output B, allowing these video sig­ nals to be displayed on the monitors. NOTE! If the core system fails, the device cannot be controlled / operated. The current settings for video distribution and recording remain available.

5.2.1

Control terminal

IMPORTANT! When controlling the system via the control terminal (Touchscreen moni­ tor), it is sufficient to touch the monitor surface only gently gently. Do not touch the surface of the control terminal with sharp or contami­ nated objects as this will lead to a damaged surface or reduced image quality. Touching the desired menu function (key) directly on the control termi­ nal selects or executes this function. The control terminal is operated in the unsterile zone. If further control terminals are connected, parallel control is possible.

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GA-A 302