Storz OR1 .avm Installation Instructions Manual
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Storz OR1 .avm Installation Instructions Manual

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OR1 .avm
Rel. 1.4

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Summary of Contents for Storz OR1 .avm

  • Page 1 Installation instructions OR1 .avm Rel. 1.4...
  • Page 2 03-2023 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

    4.1 Unpacking the product  ......................17 4.2 Setting up the product  ....................... 17 4.3 Connecting the product  ......................17 4.3.1 Connecting the OR1 .avm to AIDA  ................18 4.3.2 Connecting the audio cabling ..................19 4.3.3 Connecting the HIVE router  ..................20 5 Installation and commissioning ...
  • Page 4 5.5.2 Certifying the product  ....................45 5.5.3 Troubleshooting  ......................48 6 Maintenance, servicing, repairs, and disposal  ................53 6.1 Repairing devices ........................53 6.2 Disposing of the product  ......................53 7 Subsidiaries  ............................54 Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 5: General Information

    They also describe the software configuration. Installation and putting into service must only be performed by authorized, electrotechnically qualified specialists from KARL STORZ SE & Co. KG or by an authorized contractual partner. 1.2 Other applicable documents The following documents are a part of the product and must be observed: –...

  • Page 6: Description Of Warning Messages

    NOTICE Designates a possibly harmful situation. If this is not avoided, the products could be damaged. 1.6 Contact address KARL STORZ SE & Co. KG offers training seminars for different target groups at various levels. If necessary KARL STORZ can be contacted as follows: KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34...

  • Page 7: Safety And Warning

    2.4 Risk of explosion and fire The product can generate sparks, which cause combustible or flammable gases and liquids to ignite or explode. This may cause injuries to patients, users, and third parties. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 8: Combination With Other Components

    Ensure that all electrical installations of the operation room in which the product is connected and used conform with the applicable IEC standards. 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 9: Damage Due To Ingress Of Liquid In Electrical Components

    Do not open the product. Have servicing carried out by KARL STORZ or a company authorized by KARL STORZ. Do not touch the output jacks of the product and the patient at the same time during use Always pull out the mains plug before carrying out any cleaning and maintenance work.

  • Page 10: Product Description

    LED, orange, standby USB port  OR1 .avm – Rear view Video outputs LAN connections Video inputs DP connections Audio In Potential equalization connector Audio Out Power cord socket USB ports Power fuse holder ACC connections Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 11: Possible Combinations

    Please note that the described products in this medium may not be available in all countries due to different regulatory requirements. The following diagram shows one option for integrating the OR1 .avm and the KARL STORZ AIDA system required for control (WD300 and WD350), software version 1.7 or higher, or AIDA C (WD310 and WD360), software version 1.1 or higher.

  • Page 12: Technical Specifications

    2x ACC Power supply Power supply (AC) 100–240 V Operating frequency 50/60 Hz Line fuse 2x T 5 A 250 V, 5 x 20 mm BK/S506-5-R Max. input current 2.5 A (@100 V AC), 1 A (@ 250 V AC) Operating mode Continuous operation Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 13: Symbols Employed

    The OR1 .avm contains a lithium battery that needs to be checked and replaced regularly. 3.5 Symbols employed 3.5.1 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Medical device Article no. Serial number Number of products in the product packaging Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...
  • Page 14 EU directives. A code number after the CE mark indicates the responsible notified body. The EU directives relevant to the product can be found in the EU Declaration of Conformity, which can be requested from KARL STORZ. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 15: Symbols On The Product

    Federal (USA) law restricts this device to sale by or on the order of a physician. FCC label Non-ionizing electromagnetic radiation Separate collection of electrical and electronic devices. Do not dispose of in household refuse. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 16: Ambient Conditions

    EU directives. A code number after the CE mark indicates the responsible notified body. The EU directives relevant to the product can be found in the EU Declaration of Conformity, which can be requested from KARL STORZ. 3.6 Ambient conditions Transport and storage conditions Temperature -10°C ... +60°C (14°F ... 140°F)

  • Page 17: Preparation

    4.3 Connecting the product After connecting, a safety check must be performed by authorized, electrically trained specialists from KARL STORZ SE & Co. KG or an authorized contractual partner. If the product is connected to multiple devices via a portable multiple socket outlet on a cart, the following measures apply: Installation instructions •...

  • Page 18: Connecting The Or1 .Avm To Aida

    If necessary, use an isolation transformer. 4.3.1 Connecting the OR1 .avm to AIDA Connect the LAN2 port of the OR1 .avm and the LAN2 port of the AIDA with a CAT6 cable. Call up the AIDA configuration area. Click on the Network tab in the General menu.

  • Page 19: Connecting The Audio Cabling

    Preparation In the LAN2 drop-down menu, select the Direct connection OR1 .avm status. Connect the AIDA LAN1 port to the hospital network. If the Streaming function is to be used, connect the OR1 .avm LAN1 to the hospital network. 4.3.2 Connecting the audio cabling The following diagram shows how to connect the audio devices to OR1 .avm:...

  • Page 20: Connecting The Hive Router

    Connect the HIVE router LAN1 port to the hospital network. Call up the AIDA configuration area. Click on the Network tab in the General menu. Open the LAN2 drop-down menu and select HIVE Router. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...
  • Page 21 Preparation Deactivate the WLAN connection of AIDA. Connect OR1 .avm to other devices as per the connection diagram, See section Possible combinations [p. 11]. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 22: Installation And Commissioning

    Update AIDA C to at least software version 1.1, if not higher. When updating the software, run the update on OR1 .avm first and then on AIDA. These updates can only be performed by a KARL STORZ service technician. 5.1.1 Activating routing Start AIDA.

  • Page 23: Setting Windows Time Service

    Log in again as system administrator. ð The Windows desktop appears. Open the Services application from Windows. Click on Windows Time Service. Double-click on the Properties button. Select Automatic as the startup type. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 24: Connecting Or1 .Avm With Aida

    Enter a password chosen by you and click on Connect. Confirm by pressing OK to save the password. If the connection between AIDA and OR1 .avm is lost, reenter the password. ð Once the connection is successfully established, the following message appears: Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 25: Activating Remote Service

    ð The next time the system is booted up, the OR1 .avm interface can be accessed via the Routing menu. 5.2 Configuring the system Click on the Settings button on the AIDA user interface. Log in as application administrator. ð The configuration area appears. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 26: Configuring Streaming

    Participants can be invited to the operation in the following ways: – Via the web portal – Via an e-mail invitation – Via SCENARA .live 5.2.1.1 Setting up the network connection Click on the Routing menu. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...
  • Page 27 ð OR1 .avm will connect to the network if network access via DHCP is permitted and the DHCP checkbox is activated. ð If network access via DHCP is not permitted, you will need to enter further details. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...
  • Page 28 Complete all the fields. Make sure that only one e-mail is entered in the E-mail Sender Address field. Ensure that the sender's e-mail address is valid as this is also used to send status messages. Click on the Test Settings button. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 29: General Settings

    Open the PiP Size drop-down menu and select the size of the PiP image. Three sizes are possible: – Small: 1/5 of the image – Medium: 1/3 of the image – Large: 1/2 of the image The settings do not affect the PaP setting or the standard image. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 30: Selecting Sources

    If you are using the camera control units 22201020/22202020, activate the checkbox to ensure that the color is reproduced correctly. If you are using a separate video scaler, deactivate the checkbox in column 22201020/22202020. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 31: Selecting Targets

    5.2.5 Connecting the room camera Power supply via Ethernet (PoE) is not possible on the KARL STORZ HIVE router. Configure the room camera to IP address 192.168.1.28 or 192.168.1.29. Under Sources, select the camera where the video input is connected.

  • Page 32: Forbidden Routes

    Assignments between the source and target can be ruled out on the Forbidden Routes tab. This function can be used, for example, to prevent 3D data from being sent to a monitor that does not support 3D images. Click on the Forbidden Routes tab. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 33: Setting Up The Scenara Connection

    If there is no user name or password, leave the fields blank. Click on the button with three dots and select the server certificate for SCENARA. Click on the Test Settings and update rooms button. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 34: Pre-Configuration

    Names of sources and targets – Forbidden routes – The e-mail addresses of the participants for the streaming function – SMTP settings (including server certificate) – Room camera settings Click on the Pre-Configuration tab. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 35: Performing A Master Reset

    If the OR1 .avm is to be combined with another AIDA device, it may be necessary to perform a master reset. Call up the AIDA configuration area. Click on the Content tab in the General menu. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...
  • Page 36 Installation and commissioning Activate the Browser checkbox. Restart the system. After restarting, switch to the Browser menu. Click on the Add button. Activate the Activate checkbox and enter the following address: https://or1avm-system:8443/systemcontrol-service/reset Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...
  • Page 37 11. Click on the Get Reset Token button. 12. Forward the token you received to the KARL STORZ Customer Service. ð The KARL STORZ Service reads out a password and sends this password to you. 13. Enter the password at 2. Step: Enter Password provided by KARL STORZ Customer Service.

  • Page 38: Reading Out Log Files

    System status data and any error messages which may occur are logged in system log files. This data can be provided to KARL STORZ Customer Service for troubleshooting purposes. At the same time, AIDA also saves audit log files for monitoring and analyzing network access.

  • Page 39: Analyzing Log Files

    ð The storage process is displayed. ð The Export Succeeded message will be displayed when the storage process is complete. ð The log file for reading out or forwarding data to KARL STORZ Customer Service is now stored on the USB stick.

  • Page 40: Manual Upload

    You can view the current version of the installed software in the Update tab of the Configuration menu. 5.4.1 Manual upload Connect the USB medium containing the update package to AIDA. Click on the Select button. ð A window appears. Select the OR1 .avm update package. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...
  • Page 41 Click on the Upload button to start transferring. ð A progress bar appears. ð The package is checked when the upload is complete. ð If there is an error, an error message appears: Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...
  • Page 42 If you intend to perform the update at a later point in time, close the configuration page and restart or shut down OR1 .avm. ð The update package remains available. Open the Update tab in the Configuration menu and click on the Install button to start the update. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 43: Automatic Upload

    Before use, open the Routing menu and check the Preview and Routing functions. In the event of a fault, collect the system logs and contact KARL STORZ Technical Support. After the update package has been uploaded, the system is ready to start the update process.

  • Page 44: Pki Certificates

    A certificate is required for systems that have been updated to software version 1.3 or higher. In order to use the HIVE-based communication, a valid certificate must be downloaded using an iOS- enabled smartphone. Registration for use of the KARL STORZ certificate app is made via ticket request to a KARL STORZ certificate manager.

  • Page 45: Connecting An Ios-Enabled Smartphone

    Connect the Belkin adaptor to the iOS-enabled smartphone. Connect the LAN cable to the Belkin adaptor and the LAN1 port of the OR1 .avm. Start the KARL STORZ certificate app. Make sure that the app runs in the foreground throughout installation. ð The connection status between the Belkin adaptor and the OR1 .avm system appears in the app.
  • Page 46 ð When the connection to the certificate app has been established, a new entry appears in the app under Certificates: WO301 (Serial Number) Unsigned. ð The app has received the unsigned certificate. ð Under PKI Certificate, the status changes to Certificate is being downloaded. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...
  • Page 47 Installation and commissioning Log in to the app using the KARL STORZ personal access data. Make sure that there is an Internet connection. ð The app shows that the certification server is available. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 48: Troubleshooting

    ð The Deployed status is displayed in the app. 5.5.3 Troubleshooting 5.5.3.1 No connection to the certification server If there is no Internet connection, disconnect the iOS-enabled smartphone after the OR1 .avm certificate request. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...
  • Page 49 Connect the iPhone to the Internet at another location. ð In the app, the status changes from Signing to Signed. Reconnect the iOS-enabled smartphone with OR1 .avm. If OR1 .avm downloads the certificate automatically, wait until the PKI Certificate status reads Certificate available. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...
  • Page 50 See section No connection to the certification server [p. 48]. If the certification process was started by another person but not completed, click on the Reset existing CSR button and follow the instructions under See section Certifying the product [p. 45]. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...
  • Page 51 5.5.3.4 PKI certificate already exists If the certification process steps were not performed in the correct order or were performed multiple times, the certificate app reports that the certificate already exists. Press OK to confirm. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...
  • Page 52 Installation and commissioning Swipe the entry to the left. Touch Delete. ð The entry has been deleted. Restart OR1 .avm or click Generate and upload CSR. Follow the instructions, See section Certifying the product [p. 45]. Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...

  • Page 53: Maintenance, Servicing, Repairs, And Disposal

    The product meets the requirements of the Directive on Waste Electrical and Electronic Equipment (WEEE). Within the scope of application of this directive, KARL STORZ SE & Co. KG is responsible for the proper disposal of this product. The product must be disposed of in accordance with the applicable national laws and regulations at a suitable collection point for the reprocessing of electrical and electronic equipment.

  • Page 54: Subsidiaries

    KARL STORZ Industrial** E-Mail: info-lt-lv@karlstorz.com Gedik Is Merkezi B Blok, Kat 5, D 38-39, Bagdat Cad. No: 162, Maltepe Istanbul, Turkey Phone: +90 216 442 9500, Fax: +90 216 442 9030 **Sales for Industrial Endoscopy Installation instructions • OR1 .avm • PFU293_EN_V3.0_03-2023_II_CE-MDR...
  • Page 55 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, Lebanon...
  • Page 56 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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