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MEDRAD

®

 Stellant  ISI 700 Module Operation and Installation Manual             

                                    

20 

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
IEC 61000-4-6

3Vrms from 150kHz to 80 MHz at 80% AM 1kHz
6Vrm, 80% AM 1kHz at ISM frequencies listed below:

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.

Recommended separation distance

d

 = 1.17

 

 

Radiated RF
IEC 61000-4-3

3Vrms from 80 MHz to 2.7 GHz at 80% AM 1kHz and specific ISM 
bands listed below:

d

 = 1.17

 

 

80 MHz to 800 MHz

d

 = 2.33

 

 

  800 MHz to 2.7 GHz

Where 

is the maximum output power rating of the 

transmitter in watts (W) according to the transmitter 
manufacturer and 

d

 is the recommended separation 

distance in meters (m).

Field strengths from fixed RF transmitters, as 
determined by an electromagnetic site survey,

a

 should 

be less than the compliance level in each frequency 
range.

b

Interference may occur in the vicinity of equipment 
marked 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. Electromagnetic propagation is affected by absorption and reflection  from structures, objects 
and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and 
FM radio broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an 
electromagnetic site survey should be considered. If the measured field strength in the location in which the system is used exceeds the applicable RF 
compliance level above, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be 
necessary, such as reorienting or relocating the system.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Frequency 

(MHz-ISM List)

Test Level 

(Vrms)

1.8 - 2.0

6

3.5 - 4.0

6

5.3 - 5.4

6

6.765 - 6.795

6

7.0 - 7.3

6

10.1- 10.15

6

13.553 - 13.567

6

14.0 - 14.2

6

18.07 - 18.17

6

21.0 - 21.4

6

24.89 - 24.99

6

26.957 - 27.283

6

28.0 - 29.7

6

40.66 - 40.70

6

50.0 - 54.0

6

Frequency

(MHz)

Modulation

Type

Modulation

Frequency

Field 

Strength

(Volts/meter)

385

Pulse

18 Hz

27

450

Pulse

18 Hz

28

710

Pulse

217 Hz

9

745

Pulse

217 Hz

9

780

Pulse

217 Hz

9

810

Pulse

18 Hz

28

870

Pulse

18 Hz

28

930

Pulse

18 Hz

28

1720

Pulse

217 Hz

28

1845

Pulse

217 Hz

28

1970

Pulse

217 Hz

28

2450

Pulse

217 Hz

28

5240

Pulse

217 Hz

9

5500

Pulse

217 Hz

9

5785

Pulse

217 Hz

9

Содержание MEDRAD SCT 110

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

Страница 2: ......

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...

Страница 29: ......

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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