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General information

Instructions for use • AIDA C WD310 • AAB272_EN_V2.0_12-2021_IFU_CE-MDR

1 General information

1.1 Read the instructions for use

If the instructions for use are not followed, patients, users, and third parties may be injured or
the product may be damaged.

Read the instructions for use carefully and follow all the safety notes and warnings.

Read the reprocessing instructions carefully and follow all the safety notes and warnings.
The reprocessing instructions can be downloaded from www.karlstorz.com/ifu by entering
the item number.

Keep the instructions for use and reprocessing instructions in a safe place.

1.2 Read the instructions for use of compatible products

If the instructions for use of compatible products are not followed, patients, users, and third
parties may be injured or the product may be damaged.

Read the instructions for use of the compatible products carefully and follow all the safety
notes and warnings.

Read the reprocessing instructions of the compatible products carefully and follow all the
safety notes and warnings.

1.3 Scope

This instruction manual is valid for:

Product name

Item number

AIDA C

WD310

1.4 Other applicable documents

The following documents must also be observed:

–

AIDA C System Security Plan

–

AIDA C installation instructions

–

Regulatory information on Intel Corporation radio receiver

1.5 Description of warning messages

To prevent any injury to persons or damage to property, the warnings and safety notes in the
instructions for use must be observed. The warnings use the following levels of danger:

WARNING

Designates a possible imminent risk. If this is not avoided, it could lead to death or serious
injuries.

CAUTION

Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.

Содержание AIDA C WD310

Страница 1: ...Instructions for use AIDA C WD310 Release 1 1 en...

Страница 2: ...illustrations product descriptions and texts are the intellectual property of KARL STORZ SE Co KG Their use and reproduction by third parties require the express approval of KARL STORZ SE Co KG All ri...

Страница 3: ...3 7 Dangers from electrical current 10 3 8 Electromagnetic interference 11 3 9 Damage due to ingress of liquid in electrical components 11 3 10 Risk of explosion and fire 11 3 11 Observing ambient co...

Страница 4: ...4 1 KARL STORZ AIDA Secure 64 6 4 2 Installing and approving hardware and software components 64 7 Operation 71 7 1 Switching on the product 71 7 2 User interface 71 7 2 1 Home screen 72 7 3 Current...

Страница 5: ...for radiated and conducted immunity tests 99 10 6 Table 4 Emission class and group 100 10 7 Table 5 Recommended separation distances between portable and mobile HF communications equipment and the pr...

Страница 6: ...injured or the product may be damaged Read the instructions for use of the compatible products carefully and follow all the safety notes and warnings Read the reprocessing instructions of the compatib...

Страница 7: ...General information Instructions for use AIDA C WD310 AAB272_EN_V2 0_12 2021_IFU_CE MDR 7 NOTICE NOTICE Designates a possibly harmful situation If this is not avoided the products could be damaged...

Страница 8: ...is for examination and information purposes and not primarily for making diagnoses The recorded audiovisual data is not intended to be shown intraoperatively on the operation monitor 2 2 Indications R...

Страница 9: ...g properties for example before and after every use Functionality Damage Changes to the surface In the case of several components completeness and correct assembly Do not continue to use damaged produ...

Страница 10: ...ers or third parties All electrical installations of the operating room in which the product is connected and used must meet the applicable IEC standards Input and output equipment connected to the pr...

Страница 11: ...advice from KARL STORZ Before use a clinical biomedical engineer or an EMC specialist should carry out an ad hoc test of the electromagnetic radiation To prevent increased electromagnetic emissions or...

Страница 12: ...instructions for use and reprocessing 3 12 Failure of products The product may fail during use Have a replacement product ready for each application or plan for an alternative surgical technique 3 13...

Страница 13: ...during a system recovery Back up existing data before formatting the hard disk Only transfer encrypted data Ensure that data storage is finished and only then remove an external storage medium Perfor...

Страница 14: ...operating state 4 Access to hard disk LED red 2 Standby LED yellow 5 USB 3 0 3 ON LED green WARNING Electric shock There is a voltage of 12 V 2 A at the Smart Screen socket Do not touch the socket dur...

Страница 15: ...ance with IEEE 802 11ac Channel width bidirectional 20 MHz 40 MHz 80 MHz Preferred frequencies bidirectional Channel used is determined by external infra structure access point Bandwidth receiver 2 4...

Страница 16: ...touch screen models Use the supplied DisplayPort cable to connect touch screens Alternatively you can use a DVI D single link cable 18 1 with a maximum length of 3 m and two ferrite cores Use the supp...

Страница 17: ...gh Speed HDMI cables with a maximum length of 2 m e g PureLink PS3000 020 Item Order no IMAGE1 S CONNECT TC200 IMAGE1 S CONNECT II TC201 IMAGE1 HD 22202020x IMAGE1 HUB HD 22201020x TELECAM C3 TC100 Re...

Страница 18: ...4 5 1 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Medical device Article no Serial number Number of products in the product packaging Unique Device Identifier Consult the...

Страница 19: ...rous voltage Danger of an electric shock The potential equalization is responsible for equalizing the potentials of different metal parts that can be touched at the same time or for reduc ing potentia...

Страница 20: ...h this marking the manufacturer declares the conformity of the prod uct with the applicable EU directives A code number after the CE mark indicates the responsible notified body The EU legislation rel...

Страница 21: ...t down AIDA C or log out the user Printer Display the status of the connected printer The symbol is only available if a SONY printer is connected 4 6 Ambient conditions Storage transport conditions Am...

Страница 22: ...inated 2 Inspect the device for the following characteristics Good working order Functionality Correct assembly of the components Completeness 5 3 Setting up the device The product can be operated fre...

Страница 23: ...D310 AAB272_EN_V2 0_12 2021_IFU_CE MDR 23 Nothing may be mounted in the defined free areas 5 4 Connecting the product The product may only be connected to other components by KARL STORZ service person...

Страница 24: ...each software update The configuration area displays all menus and tabs on which you can make settings Which menus and tabs are available depends on the administration role you have logged in with Th...

Страница 25: ...ng can be defined and enabled on the User Interface tab System language Keyboard layout Start screen Onscreen keyboard 1 Tap the General menu The User Interface tab is displayed 2 Place a check mark n...

Страница 26: ...The Content tab is used to set up the system s range of functions 1 Tap the Content tab 2 Enable or disable the required modules 6 1 2 3 Display The Display tab is used to make the settings for the o...

Страница 27: ...twork are made on the Network tab 1 Tap the Network tab 2 Make the required settings 3 Tap Apply Settings 4 Press OK to confirm 6 1 2 5 DICOM CAUTION Data privacy If an encryption protocol is not sele...

Страница 28: ...on is displayed on the user interface 6 Enter the following in the fields Server AET AE title of the DICOM worklist server Server IP IP address of the DICOM worklist server Port port of the DICOM work...

Страница 29: ...ment again 3 Tap the Delete button to delete an incomplete open commit from the list 4 Tap the Refresh button to update the list The list is updated automatically every 30 seconds Messages during tran...

Страница 30: ...thin the con figured timeout period Wait for transmission to take place CommitIn complete Normal No Commit request was sent for at least one object Observe the timeout period then re send the Commit r...

Страница 31: ...The Security tab is used to set up access control 1 Tap the Security tab 2 Check the required checkboxes 3 Complete the Caption and Text fields This text is displayed to every user when they log in 4...

Страница 32: ...2021_IFU_CE MDR 32 6 1 2 9 Remote Access 1 Tap the Remote Access tab 2 Place a check mark next to Enable Remote Access 3 Press OK to confirm 6 1 3 Capture 6 1 3 1 General The General tab is used to co...

Страница 33: ...tes or storage requirements If the signal is transmitted in Full HD a second signal can be captured as a video or still image 6 1 3 2 Watermark The Watermark tab is used to specify whether the capture...

Страница 34: ...ory and confirm with Open The place where the watermark logo is stored must be on the local hard disk If necessary a relevant archive must be created by a service technician 4 Adjust the size of the w...

Страница 35: ...elect the desired entries in the Available Fields list 3 Tap the arrow to copy the entries to the Watermark Fields list 4 Place the entries in the order in which they are to appear on the images 5 Pre...

Страница 36: ...The Remote Control tab is used to specify the assignment and functioning of the remote control Depending on the installation the remote control can be set up for the footswitch and if necessary for t...

Страница 37: ...1 and 2 Start or stop a video recording from source 1 and source 2 at the same time None No function Remote control via camera head buttons 1 If a foot pedal is connected start by setting up the foot...

Страница 38: ...Enable Voice Control 3 Enter an activation word in the Voice Control Keyword field 4 Adjust the Voice Control Commands if necessary 5 Press OK to confirm 6 1 4 Finish 6 1 4 1 Mandatory and optional T...

Страница 39: ...o allow data to be stored automatically check the relevant checkboxes in the list When storing manually all data is stored 6 To enable data to be retrieved again for display and editing purposes check...

Страница 40: ...automatically enabled 3 To add further destinations for data storage repeat steps 1 and 2 4 Check the Reference checkbox to allow saved data to be retrievable again for displaying and editing in the F...

Страница 41: ...for the recordings Check the Remove Old Procedures if Needed checkbox Old exports are overwritten as of a memory capacity of less than 250 GB As of a memory capacity of 100 GB or less storage on the...

Страница 42: ...the Print tab to specify an alternative layout 5 Check the Use print layout checkbox to use the alternative layout When printing an anonymous report patient data may be mixed up 6 1 4 3 Reports The Re...

Страница 43: ...f copies Layout only available for standard template Number of images only available for standard template Time stamp Only the standard template can be altered and printed automatically during surgery...

Страница 44: ...Interface tab is displayed 2 Open the Procedure Identifier drop down menu and specify the date for primary identification of the patient 3 Specify the Mandatory Fields for documentation 6 1 5 2 Physic...

Страница 45: ...The default or group profile is linked to the performing physician The default profile is active if no performing physician is specified 3 Switch to the SuperUser user role to view the procedures Acce...

Страница 46: ...st 6 1 5 3 Instruments The Instruments tab is used to enter the identification numbers of instruments or instrument trays as well as the serial numbers of endoscopes 1 Tap the Instruments tab 2 Enter...

Страница 47: ...iality 3 Select the nature of the surgical procedure e g cystoscopy under Procedure Name 4 Select the anatomical region of the procedure e g bladder under Anatomic Region 5 Tap the Add button in each...

Страница 48: ...r not designated for the facility Should you have further questions contact the system administrator or the IT department Importing a staff group from the Active Directory 1 Activate the Active Direct...

Страница 49: ...d to assign certain access rights to individual groups of people KARL STORZ recommends making settings here to optimize your IT security Open Windows Computer Management to create new users 6 1 7 1 Ro...

Страница 50: ...a check mark next to Enable Group Profiles to create group profiles 4 Assign the group profile to the users 5 Press OK to confirm 6 1 7 2 Authentication The Authentication tab is used to configure aut...

Страница 51: ...g on the Profile Service tab for the first time you must authenticate yourself with the following standard user account Username Admin Password 12345 It is then mandatory to change the password in ord...

Страница 52: ...inst man in the middle attacks This certificate is generated in the profile service program directory when the profile service is installed The certificate file is not automatically distributed for se...

Страница 53: ...272_EN_V2 0_12 2021_IFU_CE MDR 53 1 Tap the Remote Service module 2 Place a check mark next to Enable Remote Service 3 Complete the fields 4 Press OK to confirm 6 1 9 Routing 1 Tap the Routing module...

Страница 54: ...to confirm 6 3 User roles and access rights The following user roles with various authorizations are predefined for configuration User role Group Field of activity Authorization System administrator A...

Страница 55: ...s be created for different user groups for which field specific settings are required for example Profiles that you create yourself are referred to as group profiles 6 3 2 Profile management Profile m...

Страница 56: ...stem administrator has activated group profiles the window Manage Profiles appears 6 3 4 Creating user accounts User accounts are created and managed via the Windows operating system The individual ac...

Страница 57: ...sioning Instructions for use AIDA C WD310 AAB272_EN_V2 0_12 2021_IFU_CE MDR 57 6 Right click on the Users folder and select New User in the context menu The following window appears 7 Enter the user d...

Страница 58: ...WD310 AAB272_EN_V2 0_12 2021_IFU_CE MDR 58 8 Right click on the new user and select Properties in the context menu 9 Select the Member of tab 10 Click the Add button 11 In the text field enter one of...

Страница 59: ...es as well as the predefined default profile Configuration of the profile service which distributes the default and group profiles to all AIDA applications Configuration of the remote service The tabl...

Страница 60: ...vides an overview of the settings which the application administrator may make Menu Tab Settings General User Interface Enable Onscreen Keyboard Select country and language variant Select keyboard Sel...

Страница 61: ...rmark logo scaling Specify watermark trans parency amount Enable watermark fields Select watermark fields Capture Feedback Enable feedback for a cap tured image Enable feedback for a recorded video Se...

Страница 62: ...s Enter clinical speciality Enter procedure name Select anatomic region Assign keywords Staff groups Import staff groups from the Active Directory Browser Browser Add connections to for ex ample strea...

Страница 63: ...profile and default profile The system administrator can decide that only the supplied default profile should be used The default profile is automatically loaded following login and the configuration...

Страница 64: ...g hardware and software components Damage to the operating system Viruses and other malware can damage the operating system during installation processes Check the data carrier and the software to be...

Страница 65: ...Installation and commissioning Instructions for use AIDA C WD310 AAB272_EN_V2 0_12 2021_IFU_CE MDR 65 6 Click the Next button...

Страница 66: ...Installation and commissioning Instructions for use AIDA C WD310 AAB272_EN_V2 0_12 2021_IFU_CE MDR 66 7 Enter the following service key Service MLAACDET ACAA HHTPZATZ The entry is case sensitive...

Страница 67: ...0_12 2021_IFU_CE MDR 67 8 Enter the reason for service and click Next The system is now in Service Mode New system components can be installed 9 Run the installation program 10 Restart the system if n...

Страница 68: ...ommissioning Instructions for use AIDA C WD310 AAB272_EN_V2 0_12 2021_IFU_CE MDR 68 11 Once installation is complete activate I ve finished updating the system and click on Next The Whitelist Manager...

Страница 69: ...Installation and commissioning Instructions for use AIDA C WD310 AAB272_EN_V2 0_12 2021_IFU_CE MDR 69 12 Select Automatically approve all changes and click on Next...

Страница 70: ...and click on Next The Whitelist Manager creates a new system certificate 14 Click the Finish button The software is now installed and has been checked by the Whitelist Manager Service Mode is ended 1...

Страница 71: ...are will start up 4 Have the user rights set up by the administrator 7 2 User interface The user interface has the following structure 1 2 3 4 5 1 Information bar 4 Navigation bar 2 Title bar 5 Applic...

Страница 72: ...a and documenting the current procedure Previous procedure Displaying previously created patient docu mentation and completing the documentation of previous procedures Control Optional module for the...

Страница 73: ...nature of the procedure 1 Tap the Patient module 2 Select the performing physician The settings for the current procedure are loaded 3 Record the patient data manually or load it from the hospital in...

Страница 74: ...Performing Physician The profile with all the settings for the selected physician is loaded 3 Complete and check the requested data The entries are saved automatically 4 Tap the Change button to make...

Страница 75: ...ing Nurse X Anesthetic Nurse X Clinical Special ity X X X Procedure re lated Data Procedure Name X X X Anatomic Region X X X Laterality X X X Procedure Com ment X X Tray 1 X Instrument re lated Data T...

Страница 76: ...d to a DICOM server patient data can be selected and loaded from the DICOM worklist The data set is write protected and cannot be edited 1 Tap the WORKLIST button The DICOM worklist is displayed 2 Sel...

Страница 77: ...and the system must be connected The loaded data set is write protected and cannot be edited The patient has been created in the HIS The system is connected 1 Enter the patient ID or admission ID cas...

Страница 78: ...lay Operating element Description Capture still Record video The preview area for created stills and videos displays the following information The number of stills or video sequences created The total...

Страница 79: ...he buttons on the user interface or via a voice command They can also be captured or recorded using a foot pedal or the camera head buttons 1 Tap Capture still or Record video in the Input 1 or Input...

Страница 80: ...080p 16 Mbit sec 120 MB min 720p 8 Mbit sec 60 MB min SD 3 Mbit sec 23 MB min Normal 1080p 4 Mbit sec 30 MB min 720p 2 Mbit sec 15 MB min SD 1 Mbit sec 8 MB min Voice commands Compatible microphone sy...

Страница 81: ...o Replay and images are labeled with Recorded Image Replay 1 Tap the desired capture A drop down menu appears 2 Tap the View button 3 Tap the side arrows to view the captures one after the other The m...

Страница 82: ...a capture 1 Tap the capture you want to delete A menu appears 2 Touch the Delete button The capture is marked as deleted 3 Tap Restore to restore the capture during the ongoing procedure The capture...

Страница 83: ...ect the desired entry 4 Enter the desired term in the text field 5 Press OK to confirm The annotation appears under the image 7 3 3 Edit Stills and video sequences can be post edited in the Edit modul...

Страница 84: ...elect all Select all flagged Select all unflagged Captures are shown played back in a sepa rate viewer The captures can be viewed one after the other using the arrows at the side The selected captures...

Страница 85: ...is only enabled if data that has been marked for deletion is available Printouts may contain display errors and must not be used for diagnostics and therapy purposes When printing out an anonymous re...

Страница 86: ...ve button to save the changes as an additional image 7 3 4 Finish The Finish module is used to initiate data storage All videos and stills which are not designated for deletion are saved Any data that...

Страница 87: ...which data can or must be stored appears 2 Check whether the data storage locations have been configured 3 To store data check the checkboxes for the destinations 4 Connect a USB stick or insert a CD...

Страница 88: ...splayed in the information bar Ensure that there is enough storage space available on the hard disk 7 3 4 3 Forced restart during data backup The RAM on the hard disk is continuously monitored Once a...

Страница 89: ...displayed 2 Open the Select Source drop down menu and select the required data source The available data is shown as a table 3 Open the Parameter drop down menu and select a search criterion 4 Enter t...

Страница 90: ...d stills or videos 7 4 2 Open tasks The following actions issues can result in open tasks There is not enough storage space Network disruptions occur during data transmission The memory is overloaded...

Страница 91: ...n and communication modules can obtain access The tabs can be opened via the home screen If the Home button is not displayed this function is not available The following equipment and systems can be c...

Страница 92: ...as a result of deficiencies with the product and accessories Shut down the product Have the deficiencies repaired by persons authorized by KARL STORZ Regardless of the national accident prevention reg...

Страница 93: ...nfections products must first be decontaminated KARL STORZ reserves the right to send back contaminated products 8 4 Disposing of the product The product meets the requirements of the Directive on Was...

Страница 94: ...ad DE 20040240DE USB silicone keyboard with touchpad ES 20040240ES USB silicone keyboard with touchpad FR 20040240FR USB silicone keyboard with touchpad IT 20040240IT USB silicone keyboard with touchp...

Страница 95: ...product may not offer sufficient protection for radio transmission operation The user might need to take mitigation measures such as relocating or re orienting the product WARNING Electromagnetic inte...

Страница 96: ...ut 20014430 Lemo 5 pin 3 0 5 x Footswitch RS232 1 3 0 9 x Control ca ble RS232 2 3 0 9 x Barcode reader WM200 scope of supply RS232 3 12 VDC 0 3 9 x Smart Screen power con nection DVI 3 0 29 x Touch s...

Страница 97: ...er lines 1 kV for input and output lines 100 kHz repetition The power supply qual ity should be that of a typical commercial or hospital environment Surges acc to IEC 61000 4 5 1 kV voltage outer cond...

Страница 98: ...7 GHz Refer to Table 2 for wireless proximity RF field test levels 3 V m 80 MHz to 2 7 GHz Immunity to con ducted distur bances induced by radio fre quency fields acc to IEC 61000 4 6 3 Vrms on 150 k...

Страница 99: ...it is used in such an environment Interference immunity tests EN IEC 60601 test level Compliance level Electromagnetic envi ronment guidelines Conducted HF distur bances acc to IEC 61000 4 6 3 Vrms 15...

Страница 100: ...ice is used exceeds the above compli ance levels the device should be monitored to ensure proper function If abnormal perfor mance is observed additional measures may be necessary such as re orienting...

Страница 101: ...ed power of the transmitter W Separation distance d m according to the transmitter frequency 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38...

Страница 102: ...device be returned to KARL STORZ for repair etc 1 Tap Delete All Data from the System A prompt appears 2 Press OK to confirm A warning appears 3 Press OK to confirm The window for the Windows authenti...

Страница 103: ...e D drive Data should be backed up in advance as all data on the hard disks is deleted during system recovery The data can be saved via Windows and Windows Explorer to a backup data carrier by means o...

Страница 104: ...the Install New System button A window opens 8 Press OK to confirm The system data is deleted 9 If the message Restoring image finished please reboot appears in the Logfile window on the left press t...

Страница 105: ...as OR1 User again Remove the recovery USB stick Full recovery is complete 11 2 3 Operating system recovery With operating system recovery only drive C is recovered Drive D is untouched To allow the o...

Страница 106: ...s and messages Instructions for use AIDA C WD310 AAB272_EN_V2 0_12 2021_IFU_CE MDR 106 5 Select the entry Manage BitLocker 6 In the window that follows click on Back up your recovery key in the Data D...

Страница 107: ...n be used for saving The same USB stick must be used when restarting for the first time after recovery 9 Confirm the saving dialogue and close the window with Finish 11 2 4 Performing system recovery...

Страница 108: ...Errors and messages Instructions for use AIDA C WD310 AAB272_EN_V2 0_12 2021_IFU_CE MDR 108 6 Enter the password standard password 123456 The following window opens in BIOS...

Страница 109: ...tdown button The system shuts down 11 When restarting for the first time ensure that the equipment is connected to the Internet in order to guarantee the necessary registration with Microsoft 12 Ensur...

Страница 110: ...for system recovery 19 The system shuts itself down NOTICE Restart The next time AIDA is started the system logs in as OR1 User again With every start decryption takes place in the background 20 Remov...

Страница 111: ...ARL STORZ Endoscopy Suomi OY Taivaltie 5 01610 Vantaa Finland Phone 358 0 96824774 Fax 358 0 968247755 E mail asiakaspalvelu karlstorz fi KARL STORZ SE Co KG Representative Office algirio St 94 LT9300...

Страница 112: ...ding B 18F Beijing IFC No 8 Jianguomenwai Street Chaoyang District 100022 Beijing People s Republic of China Phone 86 10 5638188 Fax 86 10 5638199 E mail info karlstorz com cn KARL STORZ Endoscopy Sha...

Страница 113: ...Subsidiaries Instructions for use AIDA C WD310 AAB272_EN_V2 0_12 2021_IFU_CE MDR 113...

Страница 114: ...Subsidiaries Instructions for use AIDA C WD310 AAB272_EN_V2 0_12 2021_IFU_CE MDR 114...

Страница 115: ...Subsidiaries Instructions for use AIDA C WD310 AAB272_EN_V2 0_12 2021_IFU_CE MDR 115...

Страница 116: ...RZ SE Co KG Dr Karl Storz Stra e 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone 49 7461 708 0 Fax 49 7461 708 105 E mail info karlstorz com www karlstorz com AAB272 EN V2 0 12 2021 IF...

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