Karl Storz IMAGE1 S Instructions For Use Manual
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Karl Storz IMAGE1 S Instructions For Use Manual

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  • Page 1 Instructions for use IMAGE1 S...
  • Page 2 02-2024 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

    4.3 Technical data ..........................14 4.4 Possible combinations  ....................... 16 4.4.1 Installation overview of IMAGE1 S CONNECT  ............. 16 4.4.2 Installation overview of IMAGE1 S CONNECT II  ............17 4.5 Symbols employed  ........................18 4.5.1 Symbols on the packaging  ................... 18 4.5.2 Symbols on the product ...
  • Page 4 9.3.3 Table 3 – Emission class and group  ................63 9.3.4 Table 4 – Recommended separation distances between portable and mobile HF communications equipment and the product ............... 63 10 Subsidiaries  ............................64 Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 5: General Information

    IMAGE1 S D3-LINK Extension Cable TC015 1.4 General signs and symbols The signs and symbols used in this document have the following meaning: Practical tip This sign refers to useful and important information. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 6: Description Of Warning Messages

    Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.   NOTICE    NOTICE Designates a possibly harmful situation. If this is not avoided, the products could be damaged. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 7: Normal Use

    The medical device may only be used by doctors and medical assistants with a relevant specialist qualification. 2.7 Patient population There are no restrictions in terms of patient groups for this product. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 8: Safety And Warning

    Do not touch the output jacks of the product and the patient at the same time during use Do not open the product. 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. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 9: Damage Due To Ingress Of Liquid In Electrical Components

    During installation and operation of the product, please take note of the information on electromagnetic compatibility, see chapter Electromagnetic compatibility. The discharge of a defibrillator can cause image loss. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 10: Failure Of Products

    3.9 Observing ambient condition If the device is operated in an environment which is not suitable, patients, users and third parties may be injured. Always store and operate the product in the prescribed ambient conditions. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 11: Product Description

    Power switch D3-LINK camera connection White balance IMAGE1 S D3-LINK (TC302) USB port IMAGE1 S X-LINK (TC301) H3-LINK camera connection IMAGE1 S H3-LINK (TC 300) X-LINK camera connection IMAGE1 S CONNECT (TC200) Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 12 LINK input ports HD DVI-D video output sockets Potential equalization connector 3G-SDI video output SCB input/output sockets (KARL STORZ Mains sockets Communication Bus) LAN interface, KS HIVE interface Potential equalization connector USB interface LINK output Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 13 Power switch D3-LINK camera connection White balance IMAGE1 S D-LINK (TC302) USB port IMAGE1 S X-LINK (TC301) 4U-LINK camera connection IMAGE1 S 4U-LINK (TC304) X-LINK camera connection IMAGE1 S CONNECT II (TC201) Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 14: Technical Data

    1x 3G-SDI Signal output format 1,920 x 1,080p, 50/60 Hz LINK input ports KS HIVE interface RJ45 USB interface 4x USB Image format JPEG Video format MPEG 4 SCB interface 2x 6 pin Mini DIN Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 15 Value (W x H x D) IMAGE1 S CONNECT 320 x 54 x 305 mm IMAGE1 S CONNECT II 320 x 54 x 305 mm IMAGE1 S H3-LINK 320 x 54 x 305 mm IMAGE1 S X-LINK 320 x 54 x 305 mm IMAGE1 S D3-LINK 320 x 54 x 305 mm IMAGE1 S 4U-LINK 320 x 54 x 305 mm Weight Value IMAGE1 S CONNECT 2.1 kg IMAGE1 S CONNECT II 3.1 kg IMAGE1 S H3-LINK 1.86 kg IMAGE1 S X-LINK 1.86 kg IMAGE1 S D3-LINK 1.86 kg IMAGE1 S 4U-LINK 1.86 kg Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 16: Possible Combinations

    Do not connect network devices (Ethernet, Bluetooth, or WiFi dongles) to the USB port of the product. The connection may impair operation of the product. 4.4.1 Installation overview of IMAGE1 S CONNECT If multiple KS HIVE-compatible peripheral devices are used, the OR1 HIVE router is required. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 17: Installation Overview Of Image1 S Connect Ii

    Product description 4.4.2 Installation overview of IMAGE1 S CONNECT II To use OPAL1 fluorescence imaging, the IMAGE1 S 4U-LINK (TC304) and Power LED Rubina (TL400) must also be connected via a sync cable when using the TIPCAM1 Rubina. If multiple KS HIVE-compatible peripheral devices are used, the OR1 HIVE router is required.

  • Page 18: Symbols Employed

    Product description 4.5 Symbols employed 4.5.1 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Medical device Article no. Serial number Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 19 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. This side up Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 20: Symbols On The Product

    The button appears once the X-LINK module is correctly connected. D3-LINK The button appears once the D3-LINK module is correctly connected. 4U-LINK The button appears once the 4U-LINK module is correctly connected. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 21 Product description Symbol Meaning Insufflator Printer Light source Storage/Eject Patient Presets Setup menu Info Brightness Print Video Image Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 22 Product description Symbol Meaning Image flip Enhance Parameter regions Patient data privacy Dashboard Live menu Image Software license Exit Frequency Display Contact information Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 23: Ambient Conditions

    Date and time Camera buttons White balance OPAL1 Network IMAGE1 PILOT Setup Update Remote Service 4.6 Ambient conditions Transport and storage conditions Temperature -10°C ... +60°C (14°F ... 140°F) Relative humidity 20–95% (non-condensing) Air pressure 500–1,060 hPa Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 24 Product description Operating conditions Temperature 0°C ... 40°C (32°F ... 104°F) Relative humidity 20–85% (non-condensing) Air pressure 700–1,060 hPa Max. operating altitude 3,000 m Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 25: Preparation

    Set the product down on a horizontal, flat surface or in a video cart. Make sure that the power cord can be unplugged at any time. Ensure adequate air circulation. For best thermal performance, position the product at the top of the device stack. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 26: Connecting The Product

    Use the LINK cable to connect the LINK module to the CONNECT module. Pull back the protection device of the SCB connector and insert the connector into one of the SCB sockets. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 27 11. Ensure that the monitor supports a resolution of 1,920 x 1,080 pixels. 12. If the D3-LINK module (TC302) is used in conjunction with a 3D videoendoscope, connect a compatible 3D monitor. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 28: Putting The Product Into Operation

    Only apply power to the HF electrodes and laser probe once the active parts have left the instrument channel and are in the user's field of vision, and the site of the operation is clearly recognizable. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 29 ð The connected LINK modules start automatically. Format the USB storage device as FAT 32. Connect the USB storage device to the IMAGE1 S CONNECT to store still images or videos. Do not connect more than 1 USB storage device. Check the values set for the primary source and the secondary source.

  • Page 30: Performing The White Balance

    Press the White Balance button on the IMAGE 1 CONNECT or the button in the Live menu. ð The white balance is performed. Check the monitor to see whether the white balance was successful. Repeat the white balance if required. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 31: Application

    The number of images per page and the number of copies can be set in the Printer menu. On the Storage/Eject button, read off the amount of used storage space on the connected USB storage device. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 32: Live Menu

    Switching off the product followed by switching off the printer will clear the print queues. Everything in the queues will be deleted. Switch the IMAGE1 S off and back on again to clear the queue. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 33 20. Tap the Insufflator button. 21. In the Insufflator menu, adjust the settings for Gas, Flow, and Pressure. 22. Tap the Display button, see chapter Display (Live menu) [p. 36]. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 34 28. Tap the IMAGE1 PILOT button to assign functions to the IMAGE1 PILOT buttons. 29. Tap the Exit button to exit the Live menu. Alternatively, press the ESC key or right side button on the IMAGE1 PILOT. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 35: Enhance (S-Technologies)

    The monochromatic visualization displays the NIR signal in grayscale. No white light information is displayed. Overlay Opacity Set the overlay opacity of the NIR signal. The white light information remains (for TH121) unchanged. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 36: Display (Live Menu)

    ð If a D3-LINK or 4U-LINK is selected as the primary source and 3D equipment is connected, the secondary source is deactivated. Activate the Grid option to fade a grid into the camera image. 10. Set the grid transparency in Grid Visibility. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 37: Setup Menu

    To amend the LINK-specific settings, tap a displayed LINK module. Tap the Head Button button to assign functions to the camera head or videoendoscope buttons. Tap the Setup button and set which visualization modes are to appear in the S-menu. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 38 14. Tap the Dashboard button and select the icons to be displayed on the dashboard here. 15. Tap the Live Menu button and select the icons to be displayed in the Live menu. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 39 29. Tap the Remote Service button to adjust software update settings and to perform software updates. 30. Tap the Insufflation button and, in the dashboard, select the insufflator functions that can be set in the Live menu. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 40: Display (Setup Menu)

    If the IMAGE1 S CONNECT II (TC201) is used with connected D3-LINK, 4U-LINK, and 3D equipment, select outputs DP-1, DP-2/DVI, and SDI as 2D or 3D mode. Open the SDI Output Resolution drop-down menu and select the resolution of the signal outputs (available only with IMAGE1 S CONNECT II (TC201)). Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 41: Network

    Monitor internal network activity to identify attack attempts. The following network parameters can be called up: – Internet Protocol Version 4 – Network address – Netmask – MAC address – DNS server Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 42 In KS HIVE Device Integration, switch the KS HIVE communication interface on or off as required. KS HIVE device integration enables bidirectional communication between the IMAGE1 S and KS HIVE-compatible peripheral devices. To change the KS HIVE settings, switch the CONNECT module off and back on again. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 43: Patient Data Privacy

    Tap the Patient Data Privacy button. The Patient Data Privacy menu is password-protected as standard. Enter a personal password that fulfils the following criteria: – At least 8 characters – At least 1 uppercase letter Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 44 Activate the Increased Patient Data Privacy setting to apply the cybersecurity presets. ð If this setting is activated, all sub-settings for Patient Data Privacy will be deactivated and the default settings restored. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 45 Privacy setting. The option is available at any time and provides access to the settings of the Patient Data Privacy menu when the password is reset. All patient data is cleared and the default settings are restored. This function is recommended before returning the device for service. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 46: Remote Service

    Check whether the date and time are set correctly, Setup menu. Using an OR1 patch cable, connect the product (TC200, TC201) to a network connection to connect to the Internet. If necessary, use an OR1 HIVE router. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 47: Setup

    If necessary, activate the Remote Update option to enable online software updates, see chapter Performing an update [p. 48]. If necessary, activate the E-mail Notification option to receive notifications about available software updates via e-mail. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 48: Performing An Update

    CONNECT module (TC200, TC201). Follow the instructions on the screen. Update the LINK module software. If the update fails, restart the system and repeat the update. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 49: Switching Off The Product

    Application 6.6 Switching off the product Switch the product off with the power switch. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 50: Maintenance, Servicing, Repairs, And Disposal

    Measure the patient leakage current. 7.3 Repairing the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. The maintenance steps described in this instruction manual are exempt from this rule. Please contact your local [Product/Brand variable] subsidiary or authorized dealer (see the list of subsidiaries).
  • Page 51 Contact KARL STORZ SE & Co. KG, a KARL STORZ branch or an authorized dealer to find out the address of the collection point in your area. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 52: Accessories And Spare Parts

    TC011 IMAGE1 PILOT TC014 Extension cable IMAGE1 S D3-LINK TC015 OR1 HIVE router WO10240 HIVE router US WO10307 USB silicone keyboard with touchpad, DE 20040241DE USB silicone keyboard with touchpad, CH 20040241CH Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 53 USB silicone keyboard with touchpad, US 20040241US Microscope footswitch TC019 E-Box for X-LINK TC028 Compatible camera heads for IMAGE1 S H3-LINK with S-Technologies Item Order no. IMAGE1 S H3-Z three-chip FULL HD camera head TH100 IMAGE1 S H3-Z three-chip FULL HD camera head...
  • Page 54 Accessories and spare parts Compatible camera heads for IMAGE1 S X-LINK without S-Technologies Item Order no. IMAGE1 S HX TH110 IMAGE1 S HX-P TH111 Compatible videoendoscopes for IMAGE1 S X-LINK with S-Technologies Item Order no. Video bronchoscope 11900BP Video bronchoscope...
  • Page 55 Flexible video urethro-cystoscope 11272VPU Flexible video urethro-cystoscope 11272VN Flexible video urethro-cystoscope 11272VNU Flexible HD video cystoscope 11272VH Flexible HD video cystoscope 11272VHU TROIDL flexible rectoscope 13912PKS TROIDL flexible rectoscope 13912NKS Video choledochoscope 11292VP Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 56 TIPCAM1 S 3D, 45°, dia. 4 mm 7240FA3D TIPCAM1 S 3D, 45°, dia. 4 mm 28164FA3D VITOM 3D, dia. 4 mm TH200 Compatible camera heads and videoendoscopes for IMAGE1 S 4U-LINK with S-Technologies in combination with IMAGE1 S CONNECT II Item Order no. IMAGE1 S 4U TH120...
  • Page 57 3D monitor (FHD), 32" 9832NB-3D 3D monitor (FHD), 32" TM323 3D monitor (FHD), 32" TM330 3D monitor (FHD), 26" TM263 4K 3D monitor, 32" TM350 32" 4K/3D Monitor TM351 4K/3D monitor, 55" TM450 Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 58 4K 2D Monitor, 43" TM441 KS HIVE compatible motorized support arms Item Order no. ARTIP CRUISE UR500B ARTIP CRUISE UR500C Compatible veterinary videoendoscopes for IMAGE1 S X-LINK with S-Technologies Item Order no. Veterinary videoendoscope 60914NKS Veterinary videoendoscope 60914PKS Veterinary videoendoscope 60714NKS...

  • Page 59: Electromagnetic Compatibility

    Preferably use the accessories specified in the manual. When using other than those specified in this manual, it becomes the responsibility of the user to determine compliance with IEC 60601-1-2. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 60: Test-Tables

    1 cycle @ 0° phase 1 cycle @ 0° phase power supply acc. angle angle If the user of the equipment re- to IEC 61000-4-11 quires continued operation in the event of interruptions to the Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 61 8 A/m @ 30 kHz 8 A/m @ 30 kHz close proximity, (CW modulation) (CW modulation) IEC 61000-4-39 65 A/m @ 134.2 kHz 65 A/m @ 134.2 kHz (pulse modulation) (pulse modulation) 7.5 A/m @ 13.56 kHz 7.5 A/m @ 13.56 kHz (pulse modulation) (pulse modulation) Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 62 As an alternative to FM modulation, the carrier may be pulse modulated using a 50% duty cycle square wave signal at 18 Hz. While it does not represent actual modulation, it would be worst case. Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 63 Note: At 80 MHz and 800 MHz, the separation distance for higher frequency range applies. 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 • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...

  • Page 64: Subsidiaries

    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 Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 65 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 66 Subsidiaries Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 67 Subsidiaries Instructions for use • IMAGE1 S • LZA705_EN_V4.2_02-2024_IFU_CE-MDR...
  • Page 68 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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