Storz OR1 SCB CONTROL Instructions For Use Manual

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Instructions for use

OR1 SCB CONTROL

Rel. 3.0

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Page 1 Instructions for use OR1 SCB CONTROL Rel. 3.0...
Page 2 08-2023 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
6.4 Checking the functioning of the user interface ................21 6.5 Widgets (compact menus) ......................21 6.5.1 Hiding and displaying widgets ..................23 6.5.2 Setting the set value ..................... 23 6.6 Opening presets ......................... 24 Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 4 11.5 Table 3 – Emission class and group ..................49 11.6 Table 4 – Recommended separation distances between portable and mobile HF communications equipment and the product ................49 12 Subsidiaries ............................51 Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 5: General Information
ü Prerequisite that must be met before carrying out an action. Step 1 ð Interim result of an action Step 2 ð Result of a completed action Actions in safety notes or in the case of a single step: Step 1 Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
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 • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 7: Normal Use
Normal use 2 Normal use 2.1 Indications The KARL STORZ OR1 SCB CONTROL provides central control of compatible medical equipment in the operating room during diagnostic and therapeutic procedures. 2.2 Contraindications Use is contraindicated if, in the opinion of the responsible physician, the device is not compatible with successful completion of the planned procedure due to its technical design.
Page 8: Safety And Warning
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 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: Electromagnetic Interference
In order to avoid exposing patients, users, or third parties to harmful electromagnetic interference, the product must not be operated outside of its intended EMC environment. Furthermore, the product must not be operated if the housing, cable, or electromagnetic shielding equipment is damaged. Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 11: Product Description
KARL STORZ OR1 SCB CONTROL software does not come into direct contact with the patient. The SCB PC card is used as a master node (administration) in the KARL STORZ SCB bus and thus enables the KARL STORZ OR1 SCB CONTROL software to control and visualize the connected SCB device.
Page 12: Possible Combinations
* No accessories may be connected here. 4.4 Possible combinations Touch screen models Product name Item number KARL STORZ Touch Screen 21.5" WM100 KARL STORZ Touch Screen 24" WM101 OR1 software Product name Item number KARL STORZ AIDA WD300 Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 13: Technical Data
Maintenance, servicing, repairs, and disposal [p. 42]. 4.6 Symbols employed 4.6.1 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Medical device Article no. Serial number Number of products in the product packaging Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 14: Symbols On The Device
4.6.2 Symbols on the device Symbol Meaning Follow the instructions for use. The color may differ on the product. The symbol is black/white on the packag- ing label. Ready/standby Hard disk Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 15: Symbols On The Type Plate
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. Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 16: Ambient Conditions
4.7 Ambient conditions Storage and Transport Conditions Temperature -10 °C ... +60 °C (14 °F ... 140 °F) Relative humidity 5 – 95 % Air pressure 500 – 1,080 hPa Operating conditions Temperature 10 °C ... 40 °C (50 °F ... 104 °F) Relative humidity 20 – 80 % Air pressure 700 – 1,080 hPa Max. operating altitude 3,000 m Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 17: Preparation
Remove any blockages in the air inlets and outlets when setting up the product. The product can be operated free-standing or in a rack. Ensure that the ambient conditions are observed. Observe the technical data. Install the product out of reach of patients. Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 18: Operation
The information and warnings for the connected device are shown in the header. The messages are displayed as long as the situations prevail. More information, see chapter Messages [p. 25]. Menu bar The following functions are available in the menu bar: Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 19: Icons On The User Interface
Navigation Depending on the configuration, other OR1 components can be accessed via the navigation, such as KARL STORZ AIDA. The widgets (compact menus) can be displayed and hidden using the Overview button on the right-hand side of the navigation bar. 6.2.1 Icons on the user interface...
Page 20: Equipment List
The device is in Standby mode. Pumps and insufflators: The pumps are switched off. Light sources: The emission of light is interrupted. Out of operation The device is not ready for use. Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 21: Checking The Functioning Of The User Interface
6.5 Widgets (compact menus) Widgets (compact menus) provide the functions of connected devices in a compressed view and are arranged according to categories. Insufflators HF devices Camera systems Motor-operated systems Pumps Light sources Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 22 Serial port (1) and set Mode (2) of the connected instrument for AUTOCON and BOWA ARC. – Used connection with mode (3) for COVIDIEN ForceTriad. With motor systems: Display of rotation of direction Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 23: Hiding And Displaying Widgets
Press on the Overview button again to hide the widgets. 6.5.2 Setting the set value In operating mode the widgets show the actual value of the respective device function. Pumps widget The set value can be set as follows: Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 24: Opening Presets
Application and system administrators can save defined settings for devices in presets. When a preset is selected, the device settings are updated with the values from the preset. Tap Presets in the menu bar. Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 25: Messages
Observe the instructions for use for the equipment to remedy information messages and warnings. 6.7.1 Information Information messages are shown in white font in the header. The information messages are hidden once the cause thereof has been remedied. Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 26: Warnings
High (red, flashing quickly): The problem requires immediate attention as it can affect the safety of the patient or user. – Medium (yellow, flashing slowly): The problem must be remedied at the next opportunity. Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 27 Operation – Low (turquoise, not flashing): The problem must be remedied after the operation. The priorities are also shown in the device list with a frame in the corresponding color. Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 28: Setting Equipment To Standby
ð The software is shut down and the product is switched off. Switch off all connected devices. If the Exit button is pressed for two seconds or longer, the user is logged off but the product does not shut down. Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 29: Equipment
ENDOMAT Select UP210 Hamou Endomat HAMOU Endomat 26331020-1 HF devices Autocon III 400 AUTOCON III 400 UH400 Force FX VALLEYLAB 20090390* ForceTriad COVIDIEN ForceTriad 20091390* BOWA ARC 400 BOWA ARC 400 Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 30: Equipment Views
Settings can be changed on the device with the following buttons: – Function setup – Display setup – Picture-in-picture – Keyboard Refer to the instructions for use of the respective camera system to find out which values can be set. Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 31: Light Sources
Equipment IMAGE 1 HUB IMAGE1 H3-M IMAGE 1 S IMAGE 1 S CONNECT II 7.2.2 Light sources mbi LED Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 32 Equipment Power LED RUBINA Power LED 300 Power LED 175 XENON 300 Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 33: Insufflators
Equipment D-LIGHT P 7.2.3 Insufflators ENDOFLATOR 40, ENDOFLATOR 50 Electronic ENDOFLATOR Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 34: Pumps
With the ARTHROPUMP POWER, a procedure or mode must firstly be selected on all devices, before they can be operated on the OR1 SCB CONTROL. Various settings appear in the widgets depending on the set procedure or mode. ARTHROPUMP POWER ENDOMAT LC Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 35: Hf Equipment
7.2.5.1 Widgets The HF devices AUTOCON, BOWA ARC and COVIDIEN ForceTriad have, in addition to the widgets for setting the set values, the following widgets: – Info widget – Pop-up widget Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 36 The Info widget appears if no instrument is acti- vated or if an instrument is connected to or re- moved from the HF device. The Pop-up widget appears, for example, if an alarm is active. Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 37 Equipment 7.2.5.2 AUTOCON III 400 AUTOCON III 400 7.2.5.3 BOWA ARC 400 7.2.5.4 Valleylab Force FX Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 38 Equipment 7.2.5.5 COVIDIEN ForceTriad The KARL STORZ SCB software version 1.1 and higher supports COVIDIEN ForceTriad version 3.80. The manufacturer must be contacted if another version is operated. Dialog boxes and functions which are not supported SCB does not support the following functions of the COVIDIEN ForceTriad energy platform: –...
Page 39: Smoke Pinch-Valve
The keys on the device and the buttons of the SCB are equivalent and can be operated simultaneously. The control panels on the illumination units have a higher priority status than the KARL STORZ SCB software. Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 40 The control panel of the operation room camera system includes functions for controlling the camera as well as up to two special functions. The special functions depend on the manufacturer's camera system. Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 41 Equipment Still image Camera rotation Zoom In and Zoom Out Special functions Focus settings White balance Aperture settings Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 42: Maintenance, Servicing, Repairs, And Disposal
KARL STORZ service techni- cians 8.2 Repairs to the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries). Contaminated devices may not be shipped. To prevent contact infections and airborne infections, products must first be decontaminated.
Page 43: Accessories And Spare Parts
SCB Connecting Cable, 100 cm 20090170 SCB connecting cable, length 500 cm 20090270 SCB connecting cable, length 60 cm 20090370 SCB connecting cable, length 750 cm 20090470 SCB connecting cable, length 3.700 cm 20090870 Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 44: Errors And Messages
10.1 General faults If the monitoring program detects a malfunction, the user interface is inactive. SCB must be restarted. The following message appears on the display: If the problem reoccurs, the administrator or KARL STORZ service must be contacted. 10.2 Troubleshooting Fault...
Page 45: 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 46 ± 1 kV ± 1 kV IEC 61000-4-4 for input and output for input and output lines lines Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 47 Table 2 test acc. to – Test levels for prox- – Test levels for prox- IEC 61000-4-3 imity fields from RF imity fields from RF wireless communica- wireless communica- tions equipment tions equipment Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 48 CDMA 850, LTE Band 5 1720 1700 to GSM 1800, Pulse Modulation 1990 CDMA 1900, 217 Hz 1845 GSM 1900, DECT, 1970 LTE Band 1, 3, 4, 25, UMTS 2450 2400 to Bluetooth, Pulse Modulation 2570 WLAN 802.11 b/g/n, 217 Hz RFID 2450, LTE Band 7 Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 49 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 • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 50 Note: At 80 MHz and 800 MHz, the separation distance for the 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 • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 51: 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 • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 52 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 53 Subsidiaries Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 54 Subsidiaries Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
Page 55 Subsidiaries Instructions for use • OR1 SCB CONTROL • 231SBC_EN_V2.0_08-2023_IFU_FDA...
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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