Storz AIDA WD300 Instructions For Use Manual
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Storz AIDA WD300 Instructions For Use Manual

Storz AIDA WD300 Instructions For Use Manual

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Instructions for use
AIDA WD300
Rel. 1.7

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Summary of Contents for Storz AIDA WD300

  • Page 1 Instructions for use AIDA WD300 Rel. 1.7...
  • Page 2 02-2022 Copyright © All product 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 rights reserved.

  • Page 3: Table Of Contents

    Symbols on the packaging  ................. 26 4.5.2 Symbols on the product  ..................27 4.5.3 Symbols on the rating plate ................27 4.5.4 Symbols on the user interface  ................28 4.6 Ambient conditions ......................29 Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 4 8 Maintenance, servicing, repairs, and disposal  ................. 99 8.1 Maintaining the product ....................99 8.1.1 Maintenance  ....................... 99 8.2 Safety inspection in accordance with IEC 62353 ............99 8.2.1 Visual inspection  ....................99 8.2.2 Electric measurements  ..................99 Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 5 11.1 Formatting the hard disk  ....................109 11.2 System recovery ......................110 11.2.1 Backing up data from the (D:) drive  ..............110 11.2.2 Complete system recovery  .................110 11.2.3 Operating system recovery .................112 11.2.4 Performing system recovery  ................114 12 Subsidiaries  ..........................118 Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 6: General Information

    Designates a possible imminent risk. If this is not avoided, it could lead to death or serious injuries. CAUTION CAUTION Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 7 General information   NOTICE    NOTICE Designates a possibly harmful situation. If this is not avoided, the products could be damaged. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 8: Normal Use

    2 Normal use 2.1 Intended use The KARL STORZ AIDA is intended for use by qualified personnel in the doctor's office and operation rooms. The KARL STORZ AIDA is an appliance (comprising hardware and software) for the documentation of audiovisual data and patient data during diagnostic and therapeutic procedures.

  • Page 9: Safety

    Only use devices with display capability that are identified as "display". Comply with national and local regulations. Only make changes to the product if these changes are approved by KARL STORZ. 3.5 Damaged products Damaged products can result in injury to patients, users, and third parties.

  • Page 10: Dangers From Electrical Current

    Have the device installed and put into service by authorized and trained electricians of KARL STORZ SE & Co. KG or by companies authorized by KARL STORZ. Use either the power cord supplied by KARL STORZ or a power cord which has the same properties and which bears a national mark of conformity.

  • Page 11: Damage Due To Ingress Of Liquid In Electrical Components

    Observe the information on electromagnetic compatibility, see chapter Electromagnetic compatibility [p. 102]. In case of uncertainties, seek expert 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.

  • Page 12: Failure Of Products

    Ensure that data storage is finished and only then remove an external storage medium. Perform a system test which verifies perfect functioning after adding new software or hardware. Shut down the software via the user interface or by briefly pressing the rocker switch. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 13: Product Description

    Electric shock! There is a voltage of 12 V / 2 A at the "Smart Screen" socket. Do not touch the socket during operation. Only connect or remove the cable when the product is switched off. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 14: Technical Data

    Supported 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. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 15 3D monitor TM330 3D monitor TM350 Supported camera types To connect other HDMI image sources, KARL STORZ recommends using Premium High Speed HDMI cables with a maximum length of 2 m (e.g., PureLink PS3000-020). Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 16 Footswitch Item Order no. Footswitch 20014430 Connecting cable Item Order no. Connecting cable 2.5 m 4802051 This accessory must be used if the product is installed in a housing, rack, or in-wall configuration. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 17: Full Hd With External Touch Screen

    Product description 4.4.1 Full HD with external touch screen Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 18: Full Hd With External Smartscreen And Operation Monitor

    Product description 4.4.2 Full HD with external smartscreen and operation monitor Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 19: Full Hd With Dual Image1 S And Operation Monitors

    Product description 4.4.3 Full HD with Dual IMAGE1 S and operation monitors Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 20: Full Hd With External Smartscreen And Dual Image1 S With Operation Monitors

    Product description 4.4.4 Full HD with external smartscreen and Dual IMAGE1 S with operation monitors Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 21: Full Hd With External Smartscreen And Scb Devices

    Product description 4.4.5 Full HD with external smartscreen and SCB devices Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 22: Ultra Hd 4K With External Touchscreen And 4K Monitor

    Product description 4.4.6 Ultra HD 4K with external touchscreen and 4K monitor Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 23: Ultra Hd 4K With External Smartscreen And 4K Monitor

    Product description 4.4.7 Ultra HD 4K with external smartscreen and 4K monitor Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 24: Full Hd With External Smartscreen And 4K Monitor

    Product description 4.4.8 Full HD with external smartscreen and 4K monitor Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 25: Ultra Hd 4K With External Smartscreen And Scb Devices

    Product description 4.4.9 Ultra HD 4K with external smartscreen and SCB devices Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 26: Symbols Employed

    Article no. Serial number Number of products in the product packaging Unique Device Identifier Consult the printed or electronic instructions for use Fragile, handle with care Keep dry Temperature limit Humidity limit Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 27: Symbols On The Product

    EU directives. A code number after the CE mark indicates the responsible notified body. The EU legislation relevant to the product can be found in the EU Decla- ration of Conformity, which can be requested from KARL STORZ. 4.5.2 Symbols on the product Symbol...

  • Page 28: Symbols On The User Interface

    EU directives. A code number after the CE mark indicates the responsible notified body. The EU legislation relevant to the product can be found in the EU Decla- ration of Conformity, which can be requested from KARL STORZ. 4.5.4 Symbols on the user interface Symbol...

  • Page 29: Ambient Conditions

    SONY printer is connected. 4.6 Ambient conditions Storage/transport conditions Ambient temperature -10 °C ... +60 °C Relative humidity 5–95% Air pressure 500–1,080 hPa Operating conditions Ambient temperature 5 °C ... 35 °C Relative humidity 10–90% Air pressure 700–1,080 hPa Maximum operating altitude 3,000 m Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 30: Preparation

    Ensure that the technical data is observed, Technical data. Install the product out of reach of patients. Note the free area dimensions based on the graphic to guarantee that the product is sufficiently ventilated. Defined free area Front Housing Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 31: Connecting The Product

    Preparation 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 personnel or personnel authorized by KARL STORZ. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 32: Installation And Commissioning

    Confirm with OK or by pressing ENTER. ð The Manage Profiles window, in which the currently assigned default or group profile is displayed, appears. Edit the assigned profile or reset all settings. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 33: General

    Enter the name of the operation room if the room is to be available for a room-to-room connection. Place a check mark next to Enable Home Screen to enable the home screen. 6.1.2.2 Content The Content tab is used to set up the system's range of functions. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 34 Tap the Display tab. Select the Screen Type. Select the COM Port. Check the required checkboxes. To switch to a different screen, select a connection, e.g., DVI 1. Test the settings if necessary. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 35 Open the Date Filter drop-down menu and limit the date range displayed when searching for patient data in the DICOM worklist: None: date range not limited Today: only display the patients in today's worklist Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 36 Commit request. status. Contact the DICOM administrator. Failed Error The Commitment server has sent Re-send the the response "Failed" for at least Commit request. one object. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 37 6.1.2.6 HL7 The HL7 interface can be set up in the HL7 tab. Two separate HL7 server connections can be configured: – Query patient data from HL7 – HL7 export settings Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 38 The System tab is used to make various settings at operating system level, such as network or WLAN settings. Local users can be created and free text can be stored via the Windows desktop. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 39 Complete the Caption and Text fields. This text is displayed to every user when they log If the system is to be sent to the Service team, tap the Delete All Data from the System button. Press OK to confirm. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 40: Capture

    Enter the names of the DisplayPort Source and HDMI Source. Select the required format, quality, and resolution settings. Press OK to confirm. KARL STORZ recommends setting up different capture qualities to minimize transmission rates and storage requirements. An optimized capture profile is stored for 3D sources.
  • Page 41 Adjust the size of the watermark under Watermark Logo Scaling using the Plus and Minus buttons. Set the transparency of the logo under Watermark Transparency Amount using the Plus and Minus buttons. ð The watermark created is displayed in the preview window. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 42 The Capture Feedback tab is used to specify what kind of feedback the user receives about a captured image or recorded video. Touch the Capture Feedback tab. Enable the required feedback display. To disable the feedback display, select No Feedback. Press OK to confirm. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 43: Remote Control

    No function Remote control via camera head buttons If a foot pedal is connected, start by setting up the foot pedal. ð The connections for the two camera head buttons are defined. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 44: Voice Control

    Adjust the Voice Control Commands if necessary. Press OK to confirm. 6.1.4 Checklist The safety checklist templates are stored locally on the hard disk under the file path D:\Data\Checklist\Repository. The storage location is preset. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 45: Finish

    Specify the horizontal and vertical alignment of the logo in the checklist report. 6.1.5 Finish 6.1.5.1 Mandatory and optional The Mandatory and Optional tabs are used to specify the destinations for automatic and manual data storage. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 46 The Mandatory tab is used to specify the destinations for the data backup. When saving data via the network, the accesses for this are also to be stated, e.g., DICOM or SFTP. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 47 To create an additional export destination on the hard disk D:\ or an external storage medium, tap the Hard Disk or USB export destination. Specify the name of the export destination and the file path. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 48 Treatment – Header – Logo – Patient data – Team, procedure, and patient data – Images Recommended for extended patient entry. Simple – Header – Logo – Patient data – Procedure data Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 49 Tap the button below Report Logo to select a logo. In the Header 1 field, enter a standard title for the report. If necessary, add further headings in fields Header 2 and Header 3. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 50: Data Entry

    Printing is available in the Filing Cabinet and Edit modules. 6.1.6 Data entry 6.1.6.1 User interface The User Interface tab is used to specify the scope and options for patient documentation. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 51 6.1.6.2 Team 1 and team 2 The Team 1 and Team 2 tabs are used to enter available personnel resources (users). The Performing and Referring Physicians can be managed under Team 1 and Anesthetists and Nurses under Team 2. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 52 Select the desired profile in the Group Profile list. 6.1.6.3 Instruments The Instruments tab is used to enter the identification numbers of instruments or instrument trays as well as the serial numbers of endoscopes. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 53 Confirm the entries by pressing OK. 6.1.6.4 Procedures Tap the Procedures tab. Select the medical specialization, e.g., urology, under Clinical Speciality. Select the nature of the surgical procedure, e.g., cystoscopy, under Procedure Name. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 54 Directory server. If this connection has not been set up, the settings will be deactivated or not designated for the facility. Should you have further questions, contact the system administrator or the IT department. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 55: Browser

    The Browser module is used to create connections to streaming servers, cloud services, Internet services, etc. A maximum of 5 web-based third-party products can be integrated into the AIDA system. Only products verified and approved by KARL STORZ may be used. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 56: User Management

    6.1.8 User management The User Management module is used 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. 6.1.8.1 Role management The Role Management tab is used to manage the individual groups.
  • Page 57 The Authentication tab is used to configure automatic Windows login and automatic login to the application for or1user. Tap the Authentication tab. Check the required checkboxes. Use the Plus and Minus buttons to set the time. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 58 Select the file with the "*.cer" format. ð If the certificate is valid, the following text appears: Certificate validation successful. ð The Certificate checkbox is activated. Tap the Echo button to check the validity of the certificate. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 59: Remote Service

    Installation and commissioning 6.1.9 Remote service The Remote Service module offers a KARL STORZ service technician direct access via a secure VNC connection. The product does not need to be removed from the operation room. Tap the Remote Service module. Place a check mark next to Enable Remote Service.

  • Page 60: User Roles And Access Rights

    Configuration user SettingsUsers Performing physician Creating a personal user profile in the configuration area. Super user SuperUsers Chief physician Access to all the en- tries in "Open Tasks" and to the "Filing Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 61: Default Profile

    Username Password Role or1admin or1admin – System administrator – Application administrator – User or1user or1user – Application administrator – SuperUser – Auditor – User Windows user account – Configuration user Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 62: Creating User Accounts

    Installation and commissioning KARL STORZ recommends creating a new user account with administrator rights and deactivating the standard administrator accounts. You must not forget your password. More detailed information on creating new user accounts can be found on the User Management tab.
  • Page 63 Installation and commissioning Right-click on the Users folder and select New User in the context menu. ð The following window appears. Enter the user data and click on Create. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 64 Right-click on the new user and select Properties in the context menu. Select the Member of tab. 10. Click the Add button. 11. In the text field enter one of the predefined groups, e.g., "SettingsUsers", and confirm with OK. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 65: Settings As System Administrator

    Allow the creation of group profiles Authentication Enable automatic login for lo- cal login Enable automatic Windows login Enable automatic logout after procedure finish Enable automatic logout after timeout Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 66: Settings As Application Administrator

    Enable and set the interface to the MPPS Provider Open commits Display the active, ongoing, open commits and their sta- Set up HL7 parameters Set up the interface to the HL7 server Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 67 Voice control Enable voice control for im- age capture and video recording Enter activation words Checklist General Select logo for the checklist report Specify alignment of logo Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 68 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, streaming servers, cloud services, or Internet services Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 69: Settings As Configuration Users

    Prechecked Manual Reports Print Enable auto print Select layout Specify the number of images per page Data entry User interface Team 1 Team 2 Instruments Procedures Assign keywords Staff groups Browser Browser Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 70: Group Profile And Default Profile

    KARL STORZ also recommends combination with an intrusion prevention system (IPS) in order to guarantee maximum protection of the network. KARL STORZ cannot accept any liability for malfunctions or loss of data on modified systems. 6.4.2 Installing and approving hardware and software components Damage to the operating system! Viruses and other malware can damage the operating system during installation processes.
  • Page 71 Installation and commissioning Click the Next button. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 72 Installation and commissioning Enter the following service key: Service-MLAACDET-ACAA-HHTPZATZ. The entry is case-sensitive. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 73 ð The system is now in Service Mode. ð New system components can be installed. Run the installation program. 10. Restart the system if necessary. ð The system is still in Service Mode and installation can be continued. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 74 Installation and commissioning 11. Once installation is complete, activate I've finished updating the system and click on Next. ð The Whitelist Manager checks the changes. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 75 Installation and commissioning 12. Select Automatically approve all changes and click on Next. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 76 ð The software is now installed and has been checked by the Whitelist Manager. ð Service Mode is ended. 15. Reconnect the product to the network or connect a data storage device. 16. Carry out a system test. ð Installation is complete. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 77: Operation

    The information bar displays system messages and information such as the number of open tasks. Title bar The title bar displays the data for the selected patient: – Gender – Last name – First name – Date of birth – Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 78: Home Screen

    If the home screen is deactivated, the Patient module is automatically used as the new start module. The start module can be specified individually from the application area modules. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 79: Current Procedures

    If the patient data is managed via an Internet browser, it must be ensured that the latest information is loaded and updated. The scope of the fields depends on what scope of documentation was configured. Three different input screens are available:  Simple entry Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 80: Entering Patient Data

    The table below provides an overview of what settings are available to the user in the three variants. Input data Standard Simple Extended Type of data Last Name First Name Middle Name Prefix Suffix Date of Birth Gender Patient ID Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 81 7.3.1.3 Loading patient data from the worklist If the system is connected 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. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 82 ü The patient has been created in the HIS. ü The system is connected. Enter the patient ID or admission ID/case ID. Tap the HIS button. ð The patient data is loaded. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 83: Checklist

    A gate is used to check a processing phase's documentation. If a processing phase was not documented as planned, a window opens with a report on the missing documentation. Tap the Checklist button. ð The Checklist module is displayed. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 84 ð Checkpoints that have not been documented are indicated in the progress indicator with a warning symbol. 10. Enter the last name of the patient. If this is not entered, the checklist cannot be finished. 11. Tap the Finish button to finish editing. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 85: Capture

    The preview area for created stills and videos displays the following information: – The number of stills or video sequences created – The total length of all the video sequences – The still capture time or the length of the video Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 86 Tap Capture still or Record video in the Input 1 or Input 2 section. ð The image or recording is created. To stop the video recording, tap the Record video button again. ð The most recently created image/video is displayed first in the preview area. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 87: Voice Commands

    The response to the voice command may be delayed. ü Voice control is activated. ü The activation word and the voice commands have been specified. Switch on the microphone. Say the activation word. ð The Microphone symbol turns orange. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 88 Touch the Clear button to remove the selected keyword. Adjust the playback speed and the volume using the Plus and Minus buttons. If the volume is too high, it could startle the attending physician. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 89: Edit

    Tap the Edit button. ð The Edit module appears. 7.3.4.1 Viewer The Viewer tab is used to view, print, delete, or annotate captures. All of the created stills and videos are displayed in a preview. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 90 Selected captures are marked for deletion, are not saved upon finishing, and are permanently deleted. Undo Delete Captures which have been designated for deletion can be restored. The button is only enabled if data is available. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 91 7.3.4.3 Still editing The Still Editing tab is used to adjust the brightness and contrast of the captured images. Changes to stills are saved as additional images. The original captures remain unchanged. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 92: Finish

    The destinations for automatic data storage are grayed out and the checkboxes are checked. They cannot be excluded from data storage. – The destinations for manual data storage are deactivated but not grayed out. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 93 If DICOM has been configured, the next pa- tient can be selected via the DICOM worklist. Open tasks List of incomplete exports. If the list is empty, data storage has been finished successfully. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 94: Previous Procedures

    Once the data has been saved on CD or DVD, the window Label CD/DVD appears. This provides a suggestion for labeling the data storage device. KARL STORZ recommends using this suggestion as this prevents mix-ups or assignment problems between the data storage device and patient file.
  • Page 95 Open the Parameter drop-down menu and select a search criterion. Enter the search term in the Search field. Tap the Search button. Select the desired data set. ð The following window appears: Other functions are possible: Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 96: Open Tasks

    When the system is running, the Current Open Tasks display appears in the information bar. This is followed by the number of open tasks. Incomplete patient data can be stored at any time. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 97: Control And Communication

    Only switch the product off using the switch-off button on the user interface. Tap the Shutdown button. Confirm the dialog with Shut down. ð The software is shut down and the product switches to standby mode. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 98 Operation Alternatively: Briefly press the rocker switch. ð The software is shut down and the product switches to standby mode. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 99: Maintenance, Servicing, Repairs, And Disposal

    Shut down the product. Have the deficiencies repaired by persons authorized by KARL STORZ. Regardless of the national accident prevention regulations and testing intervals for medical devices, for this device safety checks must be performed as repeat inspections according to IEC 62353 and recorded by a qualified electrician at least once a year.

  • Page 100: Repairing The Product

    Maintenance, servicing, repairs, and disposal 8.3 Repairing the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. The interventions described in this instruction manual are exempt from this rule. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries).

  • Page 101: Accessories And Spare Parts

    USB silicone keyboard with touchpad, PT 20040241PT USB silicone keyboard with touchpad, RU 20040241RU USB silicone keyboard with touchpad, SE 20040241SE USB silicone keyboard with touchpad, US 20040241US RJ-45 network cable, length 500 cm 20040076 Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 102: Electromagnetic Compatibility

    WARNING Reduced immunity! Risk of injury! The use of accessories or cables other than those specified in the KARL STORZ instructions for use may result in increased emissions or decreased immunity of the product. The cables listed have been shown to comply with the requirements of IEC 60601-1-2.
  • Page 103 Guidelines and manufacturer’s declaration – electromagnetic immunity The product is intended for use in the electromagnetic environment specified below. The user of the product should make sure that it is used in such an environment. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 104 Immunity test acc. 3 V/m 80 MHz to 3 V/m 80 MHz to to IEC 61000-4–3 2.7 GHz 2.7 GHz for radiated, ra- * Refer to Table 2 for wireless proximity RF field test levels Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 105 4, 25, UMTS 2450 2400 – 2570 Bluetooth, Pulse modula- WLAN 802.11 tion b/g/n, 217 Hz RFID 2450, LTE Band 7 5240 5100 – 5800 WLAN 802.11 Pulse modula- tion 5500 217 Hz 5785 Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 106 = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.5 GHz Interferences may occur in the vicinity of equipment marked with the following symbol: Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 107 The customer or user of the product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF communications equipment (transmitters) and the product as recommended below, according to the output energy of the communications equipment. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 108 Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range ap- plies. Note: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorptions and reflections of buildings, objects, and people. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 109: Errors And Messages

    ð The hard disk (D:) is formatted and all the data is deleted. An information window visualizes this process. ð Once formatting is complete, a window opens to confirm that formatting has taken place. ð The system is automatically shut down after a few seconds. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 110: System Recovery

    Wait until the KARL STORZ logo appears. Press the F12 key. ð The password entry window for accessing BIOS appears. Enter the password (standard password: 123456). ð The following window opens in BIOS. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 111 11. For recovery a BitLocker encryption was saved on the connected USB stick. Do not remove the AIDA recovery USB stick. 12. When restarting, ensure that the equipment is connected to the Internet in order to guarantee the necessary registration with Microsoft. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 112: Operating System Recovery

    Log on to the system as the administrator to access the Windows operating system. Call up the Windows desktop in the Configuration menu under General > System. Log in as OR1 Admin. Open the start menu and enter "Bitlocker" into the search field. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 113 Errors and messages Select the entry Manage BitLocker. In the window that follows, click on Back up your recovery key in the Data (D:) area. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 114: Performing System Recovery

    Plug the AIDA recovery USB stick into the USB port on the front of the equipment. Start the product. Wait until the KARL STORZ logo appears. Select the F12 key. ð The password entry window for accessing BIOS appears. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 115 Errors and messages Enter the password (standard password: 123456). ð The following window opens in BIOS. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 116 ð ERROR: The password failed to unlock volume D:. "The D: partition could not be unlocked" Please enter the recovery password to unlock the D: partition: 16. Copy the 48-character password from the text file to the prompt. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 117 20. Remove the USB stick. ð Full recovery is complete. ð The next time AIDA is started, the system logs in as OR1 User again. With every start, decryption takes place in the background. Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...

  • Page 118: Subsidiaries

    Phone: +358 (0)96824774, Fax: +358 (0)968247755 E-mail: asiakaspalvelu@karlstorz.fi KARL STORZ Endoskope Greece M.E.P.E.* Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece Phone: +30 2310 304868, Fax: +30 2310 304862 E-mail: info-gr@karlstorz.com *Repair & Service Subsidiary Instructions for use • AIDA WD300 • 271AAB_EN_V2.0_02-2022_IFU_FDA...
  • Page 119 E-mail: info-az@karlstorz.com No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore Phone: +65 69229150, Fax: +65 69229155 KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L. E-mail: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,...
  • Page 120 KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 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...

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