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CT Injection System

Operation and Installation Manual

MEDRAD® Stellant Imaging System Interface (ISI)

700 Module

Содержание MEDRAD SCT 110

Страница 1: ...CT Injection System CT Injection System Operation and Installation Manual MEDRAD Stellant Imaging System Interface ISI 700 Module...

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Страница 3: ...as well as required calibration s that are needed Required reading includes the instructions for use and other materials provided with the device This also includes any hardware and software updates...

Страница 4: ...MEDRAD Stellant ISI700ModuleOperationandInstallationManual ii...

Страница 5: ...nstallation 6 Operational Checkout 8 Configuration 9 Overview of Operation 9 Injector Head Indicator Lights 10 Details of Operation 10 Hold and Test Inject features 10 Scan Delay 11 ISI Module Cables...

Страница 6: ...MEDRAD Stellant ISI 700 Module Operation and Installation Manual iv...

Страница 7: ...f allowing an injector to interface with a CT scanner Contraindications The ISI module is not to be used for any other use for which the device is not indicated This device is not to be used for drug...

Страница 8: ...mains the same Throughout the manual Display and Control Unit DCU and Certegra Workstation will be used to refer to the two when there are differences in how information is presented on the screens Sy...

Страница 9: ...in each carton ISO 15223 1 5 4 4 Warning Indicates hazardous voltages ISO 7010 W012 Indicates alternating current IEC 60417 5032 Indicates scanner connection Identifies a terminal suitable for direct...

Страница 10: ...communicating to the ISI module The scanner signals are in a state that will allow arming the injector The user is not able to arm the injector The injector is configured for ISI and it is communicat...

Страница 11: ...use 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 impro...

Страница 12: ...a soft cloth or paper towel dampened with cleaning solution Do not use strong cleaning agents and solvents Warm water and a mild disinfectant are all that are required to clean the injector Do not use...

Страница 13: ...Connect the power cable to the ISI module Ensure power indicator is illuminated 5 If a Certegra Workstation is being installed as an upgrade to an existing injector with an ISI 700 option determine w...

Страница 14: ...Operational Checkout A basic functional checkout of the ISI module should be included as part of regular maintenance Verifying proper operation of the ISI module will help in detection of any problems...

Страница 15: ...itiation The ISI module supports the following two methods 1 By pressing the injector start switch the injector notifies the scanner that it can begin the scanning sequence 2 The scanner initiates the...

Страница 16: ...d with a short flash long flash pattern Details of Operation 1 Program the scanner You will see the ISI Ready icon when the scanner is ready 2 Program the injector 3 Arm the injector NOTE For specific...

Страница 17: ...injector screen Text Box Message What it means Actions to be taken Display and Control Unit DCU Scanner not ready Certegra Workstation Imaging system not ready When the ISI module is configured On or...

Страница 18: ...ntact Bayer for further support Schematic Diagram Note Maximum rating for scanner relay contacts 0 75 A 30 VDC Minimum rating for scanner relay contacts 10 a 10mV Display and Control Unit DCU ISI modu...

Страница 19: ...at any time by disarming it This signal would immediately stop the injection of contrast If the injector is armed this signal would be high making this signal go to zero disarms the injector 25 Note...

Страница 20: ...for a Class 1 Medical Device EMI RFI The injection system is classified as Group 1 Class A equipment per the requirements of IEC 60601 1 2 Accessories provided by Bayer will also comply with this sta...

Страница 21: ...Mode of Operation Per IEC 60601 1 the mode of operation for the ISI module is continuous It is capable of operation under normal load for an unlimited period without excessive temperature being develo...

Страница 22: ...MEDRAD Stellant ISI700ModuleOperationandInstallationManual 16...

Страница 23: ...ing and measurement techniques Surge immunity test IEC 61000 4 6 Electromagnetic compatibility EMC Part 4 6 Testing and measurement techniques Immunity to conducted disturbances induced by radio frequ...

Страница 24: ...rence by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the system as recommended below according to the maximum output power of the communicat...

Страница 25: ...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 Electromag...

Страница 26: ...d with the following symbol Non ionizing Radiation Symbol IEC TR 60878 5140 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Elec...

Страница 27: ...ctor Head Indicator Lights 10 Installation 6 J L J1 Pins 13 M O Maintenance 11 Messages and Descriptions 11 Operation Details of 10 Operation Overview 9 Operational Checkout 8 P R Rating maximum 12 Ra...

Страница 28: ...MEDRAD Stellant ISI700ModuleOperationandInstallationManual 22...

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Страница 30: ...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 ar...

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