AIDA System Description Rel 1.3 Oct 2017

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System description KARL STORZ AIDA® Release 1.3_BB Software description KARL STORZ AIDA® Release 1.3_BB Instructrion manual KARL STORZ AIDA® WD200 / WD250_BB

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System Description

KARL STORZ AIDA®, Release 1.3

Welcome Thank you for your expression of confidence in the KARL STORZ brand name. Like all of our other products, this product is the result of years of experience and great care in manufacture. You and your organization have decided in favor of a modern, high-quality product from KARL STORZ.

Copyright © KARL STORZ, 10-2017 It is not permitted to forward or reproduce this document nor to use or disclose the contents thereof unless express consent is given. Violators will be sued for damages. All rights reserved in the event of patent issuance or utility model registration. Published by KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 PO Box 230 78503 Tuttlingen Germany Telephone: +49 7461 708-0 +49 7461 708-105 Fax: Email: [email protected] Web: www.karlstorz.com

Contents

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Contents

1 Safety instructions... 1-1 1. 1 Explanation of warnings and cautions... 1-1 1. 2 General safety instructions... 1-1 1. 3 Safety precautions at the installation site... 1-2 1. 4 Safety measures during operation... 1-2 2 System description... 2-1 2. 1 System requirements... 2-1 2. 1. 1System-compatible hardware... 2-1 2. 2 System versions... 2-2 3 Installation... 3-1 4 Operation... 4-1 4. 1 General... 4-1 4. 1. 1Presets, workflow, and user roles... 4-1 4. 1. 2Warnings... 4-1 4. 1. 3Switching on and off... 4-1 4. 1. 4Monitoring of memory usage... 4-2 4. 2 Start screen and navigation... 4-2 4. 2. 1Information bar... 4-2 4. 2. 2Main menu ... 4-4 4. 2. 3Application areas and modules ... 4-4 4. 2. 4Navigation bar... 4-5 4. 3 ‘Current procedure’ field of application... 4-6 4. 3. 1Introduction... 4-6 4. 3. 2Patient... 4-6 4. 3. 3Checklist... 4-13 4. 3. 4Capture... 4-15 4. 3. 5Editing... 4-21 4. 3. 6Finishing... 4-24 4. 3. 7Forced restart... 4-26 4. 4 ‘Control’ field of application... 4-27 4. 4. 1Medical Device Control – SCB... 4-27 4. 5 ‘Previous procedures’ field of application... 4-28 4. 5. 1Filing cabinet... 4-28 4. 5. 2Open tasks... 4-32 4. 6 ‘Communication’ field of application... 4-33 KARL STORZ AIDA®

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Contents

4. 6. 1StreamConnect... 4-33 Maintenance... 5-1 5 5. 1 Safety instructions... 5-1 5. 2 Reprocessing... 5-1 5. 2. 1Legal requirements... 5-1 5. 2. 2Safety instructions... 5-1 5. 2. 3Required reprocessing agents... 5-1 5. 2. 4Required reprocessing materials . ... 5-1 5. 2. 5Manual wipe-down disinfection... 5-2 5. 3 Maintenance and repair... 5-2 5. 3. 1Maintenance plan... 5-2 5. 3. 2Changing the BIOS battery... 5-2 5. 3. 3Changing the device fuse... 5-2 5. 3. 4Servicing... 5-2 5. 4 Repair program... 5-3 5. 4. 1Return of defective devices to KARL STORZ... 5-3 5. 5 Responsibility... 5-3 5. 6 Warranty... 5-3 Subsidiaries... 6-1 6

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Safety instructions

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Safety instructions

1. 1 Explanation of warnings and cautions The words Warning, Caution, and Note convey special meanings. Wherever they are used in this manual, they should be carefully reviewed to ensure the safe and effective operation of this system. To make these words stand out more clearly, they are accompanied by a pictogram.

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WARNING: A Warning indicates that the personal safety of the patient or user may be endangered. Failure to observe a Warning could result in injury to the patient or user.

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NOTE: A Note indicates special information about operating the system, or clarifies important issues.

CAUTION: A Caution indicates that particular service procedures or precautions must be followed to avoid possible damage to the system.

1. 2 General safety instructions

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WARNING: Installation and commissioning of the device must only be performed by authorized, electrotechnically qualified specialists from KARL STORZ SE & Co. KG or by an authorized contractual partner. WARNING: Only use accessories which have been specified for use with the device by KARL STORZ SE & Co. KG. WARNING: Combinations of medical devices are only assured to be safe if they are identified as such in the respective instruction manuals or the intended use and interface specifications of the devices used in combination permit this. WARNING: The various components of the device are only grounded reliably when the equipment is connected to a ‘Hospital Only’ or ‘Hospital Grade’ outlet (i.e., approved for use in an operating room environment). Routinely inspect electrical plug and cord. Do not use if inspection reveals damage. WARNING: Do not open the various components! Risk of electric shock. Any opening of the device by unauthorized persons will result in the forfeiting of all warranty claims. WARNING: Only operate the various components of the device with the voltage stated on the rating plate. WARNING: Additional devices which are connected to electrical medical devices must comply with the relevant IEC or ISO standards (e.g., IEC 60950 for data processing devices). Furthermore, all configurations must comply with the requirements for medical electrical systems (see IEC 60601-1-1 or para 16 of the 3rd edition of the IEC 60601-1). Anybody connecting additional devices to electrical medical devices is configuring a medical system, and is therefore responsible for ensuring that the system complies with the standard requirements for medical electrical systems. It should be noted that the local legal regulations have priority over the above-mentioned requirements. If in doubt, contact your representative on site or the technical customer service.

KARL STORZ AIDA®

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Safety instructions

1. 3 Safety precautions at the installation site 11

NOTE: Only those parts of the system which have been approved as medical devices are suitable for use in the proximity of patients.

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WARNING: To avoid the risk of an electric shock, the device may only be connected to a power supply with a protective conductor. WARNING: The device must only be operated under the ambient conditions specified. WARNING: Keep the various device components out of reach of patients. WARNING: Only insert the power plugs of individual devices into and remove them from electrical outlets located outside areas subject to explosion hazards. WARNING: Always unplug the device from the power supply before carrying out any maintenance work. WARNING: The installation should be carried out in such a way that the respective device is able to receive sufficient ventilation. WARNING: The use of additional multiple socket outlets or an extension cable with the system is not permitted. Warning: The use of freely accessible multiple socket outlets is not permitted. Warning: Multiple socket outlets must not be placed on the floor.

1. 4 Safety measures during operation

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WARNING: It is the user’s responsibility to make sure all devices connected to the system and the complete system are safe and operate properly before using them. The respective device should not be used if any damage is evident.

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WARNING: If the volume of the loudspeaker or the headphones is too high, an unexpected audio signal could startle the attending physician. Check volume regulation before each procedure.

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WARNING: Avoid allowing liquids to enter the device. Do not store any liquids in the vicinity of the device. If liquid penetrates the device, in spite of the precautions, sufficient time should be allowed for evaporation.

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WARNING: Do not connect any equipment to the system which has not been specified by KARL STORZ SE & Co. KG.

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WARNING: Connecting non-compatible signal types to the connection panel in the OR can cause picture interference and malfunctioning of the device. Only connect permitted signal types and perform device tests before use.

WARNING: The display of image signals which do not originate from a KARL STORZ device may only be used for information purposes. WARNING: Devices from third-party manufacturers which are able to display or play back recordings must be set before being connected to the device so that these recordings are designated as such.

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Safety instructions

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WARNING: If an external signal is routed to the surgical monitor, it must be ensured that the surgeon is aware that the local live image has been replaced by the external signal. WARNING: For safety reasons, do not simultaneously touch the device output sockets and the patient. WARNING: The device is not suitable for use in hazardous zones. This means, among other things: when using easily combustible and explosive inhalation anesthetics or mixtures thereof, the device may not be operated in the hazard zone demarcated below. This also applies for easily combustible and explosive chemicals, e.g., skin disinfectants and fast-acting surface disinfectants.

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KARL STORZ AIDA®

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Safety instructions

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System description

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System description

2. 1 System requirements Only the system components/standards approved by KARL STORZ may be used within the system. Detailed information is available from your competent KARL STORZ contact partner if necessary.

2. 1. 1 System-compatible hardware Control units • KARL STORZ AIDA™ WD200 • KARL STORZ AIDA™ WD250 with SmartScreen

Supported touch screen models • 20 0905 19 KARL STORZ touchscreen 19" • 20 0905 21 KARL STORZ touchscreen 21.5" • 20 0905 24 KARL STORZ touchscreen 24"

Supported display types 2D • 9519NB • 9524NB • 9526NBL • 9726NB • 9619NB • 9626NB • 9626NB-2 • 9627NB • 9826NB 3D • 9826NB-3D • 9832NB-3D

Supported camera types 2D • IMAGE1 S • IMAGE1 HD

3D

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• IMAGE1 S NOTE: Additional system configuration options are possible in principle, but must always be considered and planned individually. This may result in additional costs. KARL STORZ AIDA® is supplied as a unit comprising complementary hardware and software. Any changes to the hardware or software which are not authorized by KARL STORZ void both approval for medical use and the warranty.

KARL STORZ AIDA®

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System description

2. 2 System versions

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WARNING: Connecting non-compatible signal types to the connection panel in the OR can cause picture interference and malfunctioning of the KARL STORZ AIDA®. Only connect permitted signal types and perform device tests before use.

2. 2. 1 Basic system configuration when connecting a SmartScreen or touchscreen or a barcode scanner SmartScreen KARL STORZ AIDA WD250

LASER KLASSE 1 PRODUKT NACH IEC B25

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Serial/DVI Smartscreen ® Shipping Lock

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Smart Screen

Touchscreen KARL STORZ AIDA WD200

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Touch Screen

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System description

Bar code scanner (RS232) KARL STORZ AIDA WD250

LASER KLASSE 1 PRODUKT NACH IEC B25

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KARL STORZ AIDA®

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System description

2. 2. 2 System configuration for 2D and KARL STORZ IMAGE1 S (2D and 3D)

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Note: When using a 3D-compatible camera, the operation monitor must also be 3D-compatible. Note: When playing back AIDA 3D content, the monitor must be switched to Top Bottom mode (see monitor instructions).

One 2D source, one 2D monitor, no SmartScreen; playback on 2D monitor KARL STORZ AIDA WD200

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2D-Kamera

2D-Monitor

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System description

One 2D source, one 2D monitor, SmartScreen; no playback on the surgical screen KARL STORZ AIDA WD250

LASER KLASSE 1 PRODUKT NACH IEC B25

LineIn LineOut

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Serial/DVI Smartscreen ® Shipping Lock

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2D-Kamera

2D-Monitor

KARL STORZ AIDA®

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System description

One 2D source, one 2D monitor, SmartScreen; playback on the surgical screen KARL STORZ AIDA WD250

LASER KLASSE 1 PRODUKT NACH IEC B25

LineIn LineOut

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Serial/DVI Smartscreen ® Shipping Lock

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2D-Kamera

2D-Monitor

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System description

Two 2D sources, two 2D monitors, SmartScreen; playback on one of the two surgical screens KARL STORZ AIDA WD250

LASER KLASSE 1 PRODUKT NACH IEC B25

LineIn LineOut

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DVI 1

SERIAL SMARTSCREEN

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Serial/DVI Smartscreen ® Shipping Lock

2D-Kamera

2D-Monitor

KARL STORZ AIDA®

Unlock Lock

2D-Kamera

2D-Monitor

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System description

Two 2D sources, two monitors, SmartScreen, MULTISWITCH®; playback on the surgical screen KARL STORZ AIDA WD250

LASER KLASSE 1 PRODUKT NACH IEC B25

LineIn LineOut

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Serial/DVI Smartscreen ® Shipping Lock

2D-Kamera

2D-Monitor

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Unlock Lock

3D-Kamera

3D-Monitor

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System description

2. 2. 3 System configuration for KARL STORZ IMAGE1 S 3D One 3D source, one 3D monitor, no SmartScreen, playback on 3D monitor .

KARL STORZ AIDA WD200

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LineIn LineOut

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3D-Kamera

3D-Monitor

KARL STORZ AIDA®

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System description

One 3D source, one 3D monitor; playback on the surgical screen and control via the SmartScreen KARL STORZ AIDA WD250

LASER KLASSE 1 PRODUKT NACH IEC B25

LineIn LineOut

CLASS 1 LASER PRODUCT TO IEC B25

ACC

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DVI 1

SERIAL SMARTSCREEN

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LAN

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HDMI

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Serial/DVI Smartscreen ® Shipping Lock

Unlock Lock

3D-Kamera

3D-Monitor

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