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Related Manuals for Bayer HealthCare MEDRAD 800 Module
Summary of Contents for Bayer HealthCare MEDRAD 800 Module
- Page 1 Operation & Installation Manual MEDRAD® Stellant Imaging System Interface (ISI) 800 Module...
- Page 3 English ® MEDRAD Stellant Imaging System Interface (ISI) 800 Module Operation and Installation Manual Operating specifications, options, accessories, and feature availability may vary by country. Check with local product representative and country-specific operating instructions. ® The MEDRAD Stellant Imaging System Interface (ISI) 800 Module has an expected service life* of 7 years from the date of product installation when operated according to the instructions provided with this device.
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Page 5: Table Of Contents
® MEDRAD Stellant ISI 800 Module Operation Man- 1 - Introduction ................3 Installation ...................... 3 Important Safety Notice .................. 3 Indications For Use ..................3 Certifications ....................3 Contraindications ................... 3 Restricted Sale ....................3 Disclaimers ..................... 3 Monitors ......................4 Symbols ...................... -
Page 7: Introduction
® MEDRAD Stellant ISI 800 Module Operation Manual 1 - Introduction ® This manual contains important information about use of the MEDRAD Stellant Imaging System Interface (ISI) 800 Module (Catalog Number: ISI 800). Read all the information contained in this manual. Understanding this information will assist the user in safely operating the System. -
Page 8: Monitors
® Monitors In some countries, the MEDRAD Stellant CT Injection system may be purchased with a choice of two monitors, shown below - "Display and Control ® Unit (DCU)" and "Certegra Workstation." The Certegra Workstation comes in two models, shown below as Model 1 and Model 2. The Certegra Workstation hardware buttons differ slightly between Models but the screen/monitor information remains the same. - Page 9 ® MEDRAD Stellant ISI 800 Module Operation Manual Identifies the Ethernet LINK LED. Identifies the Ethernet ACTIVITY LED. CLASS 1 Indicates the ISI 800 Module is Class 1 medical equipment as defined by IEC 60601-1 standards. IPX 1 IPX1 Code that specifies the degree of protection provided by the enclosure against vertically falling water drops (IEC 60529) Identifies the Protective Earth Ground point.
- Page 10 Medical - General Medical Equipment As To Electrical Shock, Fire, and Mechanical Hazards Only In accordance with ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012) CAN/CSA-C22.2 No. 60601-1 (2014). See accompanying documentation. This symbol indicates the user shall refer to the instructions-for-use to ensure safe operation. (ISO 7010, M002) Consult instructions for use (ISO 15223-1, 5.4.3) The following icons may appear on the injector screen: Icon...
- Page 11 ® MEDRAD Stellant ISI 800 Module Operation Manual The procedure (injection plus scan) can only be initiated by pressing the start button on the injector. The procedure (injection plus scan) can only be initiated by pressing the start button on the scanner. The procedure (injection plus scan) can be initiated by pressing the start button on EITHER the scanner or the injector.
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Page 12: Warnings
Warnings Improper installation of the ISI 800 Module may cause it to fail. Installation must be completed by properly trained personnel. Contact your scanner manufacturer for configuration and installation assistance. Patient injury could result from using improper accessories. Use only accessories and options provided by Bayer and designed for the ISI 800 Module. -
Page 13: Notes
® MEDRAD Stellant ISI 800 Module Operation Manual Do not use strong cleaning agents and solvents. Warm water and a mild disinfectant are all that are required to clean the ISI 800 Module. Do not use strong industrial cleaning solvents such as acetone. Damage can occur to the system if it is subjected to excessive shock. -
Page 14: Injector Modes
Modules. CiA 425 Part 2 specification defines a standard way for an injector to behave. Classes The CiA 425 specification defines how a scanner controls an injector. In this definition they specify 6 "classes" or levels of control. Each higher number offers more features and includes all features of the previous classes. -
Page 15: Operation
® MEDRAD Stellant ISI 800 Module Operation Man- 2 - Operation Overview of With the ISI 800 Module installed, the injection system can function Operation independently or coupled to the scanner. Depending upon what mode of operation the scanner is in, this link can allow the scanner to automatically request the initiation of an injection, or permit the injector to automatically request the initiation of a scanning procedure. - Page 16 NOTE: The Display and Control Unit (DCU) screenshots used in this section show a mixture of Protocol and Profile views. 1. Program the scanner. 2. Program the injection protocol into the injector. Once the protocol has been programmed, press the Protocol Lock button. Display and Control Unit (DCU) Certegra Workstation Protocol Lock Status Icon (Shown Unlocked)
- Page 17 ® MEDRAD Stellant ISI 800 Module Operation Man- NOTE: For specific information about programming, arming and ® injecting, refer to the MEDRAD Stellant CT Injection System Operation Manual. NOTE: If the injector is configured to use the ISI 800 Module and fails to "Arm"...
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Page 18: Details Of Operation (Tracking And Control Modes)
Details of Operation The following operating instructions apply when the system is in either (Tracking and Tracking Mode (shown by an arrow pointing towards the scanner) or Control Control Modes) Mode (shown on the Monitor by a bi-directional arrow). NOTE: The Display and Control Unit (DCU) screenshots used in this section show a mixture of Protocol and Profile views and Tracking and Control modes. - Page 19 ® MEDRAD Stellant ISI 800 Module Operation Man- 4. Press the Arm button to arm the injector. Display and Control Unit (DCU) Certegra Workstation Tracking Mode - Scanner and Injector Not ready NOTE: For specific information about programming, arming and ®...
- Page 20 5. Wait until both the Injector and Scanner icons are flashing and highlighted in yellow before proceeding. Display and Control Unit (DCU) Certegra Workstation Tracking Mode - Injector Ready - Scanner Not Ready Control Mode - Scanner Ready - Injector Not Ready Control Mode - Injector and Scanner Ready...
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Page 21: Test Inject
® MEDRAD Stellant ISI 800 Module Operation Man- 6. Execute the procedure by pressing the start switch on either the scanner or injector (as determined by the scanner's configuration of the injector). • When in Control Mode: Press start switch on either the scanner or the injector (unless local start is locked out by the scanner) to request the initiation of the scan/inject sequence. -
Page 23: Specifications
® MEDRAD Stellant ISI 800 Module Operation Man- 3 - Specifications ISI 800 Enclosure Weight: 4.5 lbs. (2.04 kg) Dimensions 7.9" 20.07 cm 11.0" 27.9 cm 2.8” 7.1 cm ® Power Cords The specifications required by the MEDRAD Stellant Imaging System Interface (ISI) 800 Module relative to the power cable (plug, receptacle, and cord) are: •... -
Page 24: Environmental Specifications
Environmental Non-Operating: (Transportation and Storage) Specifications Temperature: C to 70 C (-13 F to +158 Humidity: 5% to 100% R.H., condensing Air Pressure: 48 kPa to 110 kPa Operating (The system may not meet all performance specifications if operated outside of the following conditions.) Temperature: C to + 40... -
Page 25: Appendix A - Compliance To Iec 60601-1-2 / 2Nd, 3Rd, And 4Th Editions
® MEDRAD Stellant ISI 800 Module Operation Man- Appendix A - Compliance to IEC 60601- 1-2 / 2nd, 3rd, and 4th Editions ® The MEDRAD Stellant Imaging System Interface (ISI) 800 Module complies with the requirements of: IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance –... - Page 26 WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the injection system unless a greater separation distance is required as indicated by the equation. Otherwise, degradation of the performance of this equipment could result.
- Page 27 ® MEDRAD Stellant ISI 800 Module Operation Man- THE SYSTEM REQUIRES SPECIAL PRECAUTIONS REGARDING EMC. Install and put into service according to the EMC information provided below: Guidance and manufacturer's declaration - electromagnetic emissions The system is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure that it is used in such an environment.
- Page 28 Guidance and manufacturer's declaration - electromagnetic immunity The system is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure that it is used in such an environment. Immunity test IEC 60601 Test Compliance Level Electromagnetic environment - guidance Conducted RF 3Vrms from 150kHz to 80 MHz at 80% AM 1kHz...
- Page 30 Bayer reserves the right to modify the specifications and features described herein or to discontinue any product or service identified in this publication at any time without prior notice or obligation. Please contact your authorized Bayer representative for the most current information. All patient data that appear in this document are fictitious.