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24 

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

Summary of Contents for MEDRAD 800 Module

Page 1: ...d d a t e o f i n s t a l l a t i o n i n f o r m a t i o n m u s t b e s u p p l i e S e n u m b e r s CT Injection System CT Injection System Operation Installation Manual MEDRAD Stellant Imaging Sy...

Page 2: ......

Page 3: ...s 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 th...

Page 4: ...ii ii...

Page 5: ...Cautions 8 Notes 9 System Overview 9 CiA 425 Standard 9 Injector Modes 10 Lockouts 10 2 Operation 11 Overview of Operation 11 Injector Head Indicator Lights 11 Details of Operation Monitor Mode 11 Det...

Page 6: ...2...

Page 7: ...Edition Amendment 1 and IEC 60601 1 2 2nd 3rd and 4th Edition standards including national differences Special precautions regarding Electro magnetic Compatibility EMC are required for installation a...

Page 8: ...ns Symbols The following symbols are used on the ISI 800 Module and its components Certegra Workstation Model 1 Certegra Workstation Model 2 Icon Meaning Indicates that this device conforms to the req...

Page 9: ...arth Ground point IEC TR 60878 5019 Indicates separate collection for Electrical and Electronic Equipment per Directive 2002 96 EC Refer to the following website for additional information www weee ba...

Page 10: ...he icon is the same but is vertical The configurations below are determined by the scanner manufacturer Refer to the scanner manufacturer instructions for further information The following description...

Page 11: ...e injector is working in conjunction with the scanner it is coupled This symbol will only appear on the screen when the system is in Control or Tracking modes When the icon is gray as shown the protoc...

Page 12: ...do not disassemble the ISI 800 Module in any way Worn cabling also creates hazards If any worn or damaged cables are detected do not use the ISI Module Contact Bayer or your local dealer for service...

Page 13: ...AD Stellant CT Injection System and the imaging system When the ISI 800 Module is installed the injector can function either independently or linked to the imaging system When coupled with all operati...

Page 14: ...Class 5 scanner can control flow rate of injection in real time The ISI 800 Module currently conforms to Class 1 Injector Modes There are 3 available ISI Modes which are determined by the scanner Moni...

Page 15: ...esume the injection if Hold button is pressed during the injection Protocol Configuration the injector protocol configuration cannot be changed Protocol Config Lockout does not affect the ability to u...

Page 16: ...before the injector can be armed NOTE Once the Protocol Lock button has been pressed the Protocol Lock icon in the lower left corner of the screen will be highlighted in yellow 3 Check the fluid pathw...

Page 17: ...round or indicates a communication problem with the module the ISI can be disabled so that the injector can be used stand alone To do this go to the ISI Setup screen in System set up Menu and select I...

Page 18: ...ntrol modes 1 Program the scanner 2 Program the injection protocol into the injector Once the protocol has been programmed press the Protocol Lock button NOTE The Protocol Lock button MUST be pressed...

Page 19: ...check the ISI Communication icon located at the bottom left of the Monitor If the icon is not highlighted with a yellow background or indicates a communication problem with the module the ISI can be...

Page 20: ...icons are flashing and highlighted in yellow before proceeding Tracking Mode Injector Ready Scanner Not Ready Display and Control Unit DCU Certegra Workstation Control Mode Scanner Ready Injector Not...

Page 21: ...st Inject 7 When using the ISI 800 Module test inject is not part of the actual diagnostic injection procedure therefore Scanner Ready is not required to initiate a test inject This is considered an i...

Page 22: ...18...

Page 23: ...ting Temperature 60 C minimum Receptacle Type IEC 60320 C13 Normal Cord Voltage 300 VAC minimum Wire Gauge 1 00 mm2 minimum Cord Type IEC 60245 1 Annex A Designation 53 or IEC 60227 1 Annex A Designat...

Page 24: ...and IEC requirements for safe Electrical Leakage Current limits for Medical Equipment Ground Continuity 0 2 ohms from power cord ground pin to enclosure Protection Against the Ingress of Fluids Per I...

Page 25: ...lity EMC Part 4 5 Testing and measurement techniques Surge immunity test IEC 61000 4 6 Electromagnetic compatibility EMC Part 4 6 Testing and measurement techniques Immunity to conducted disturbances...

Page 26: ...m distance between portable and mobile RF communications equipment transmitters and the system as recommended below according to the maximum output power of the communications equipment Rated maximum...

Page 27: ...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 Comp...

Page 28: ...on 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 af...

Page 29: ......

Page 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 a...

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