JEDI Generator SRS

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GE Healthcare X-Ray Generation department Jedi 100Vasc 1T CDRS

JEDI 100 VASC 1T CDRS

Author Etienne CLEMOT sign off

Jedi Liberty Project Leader Date

Reviewer Emmanuel LAFITE sign off

Jedi SW project leader Date

Reviewer Sinivassane SOMAYA sign off

Djinn project Leader Date

Reviewer Michel GENUER sign off

Liberty UPS Leader Date

Approbation Eric PAYROT sign off

Unit manager Date

Approbation Daniel DUMOURIER sign off

Jedi Platform Leader Date

Note: Before using this document, make sure it is the latest revision. Access the PDM system
to verify the current version.

Author : Etienne Clemot 2318938-2DRS rev 2 1/52


GE Healthcare X-Ray Generation department
SIGN OFF page

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Author : Etienne CLEMOT 2318938-2DRS rev 2
GE Healthcare X-Ray Generation department Jedi 100 Vasc 1T CDRS

RECORD OF CHANGES
Document Rev Date Author Description
2318938DRS 1 02/04/2004 S.SOMAYA SPR EURge04198
2318938DRS 2 30/07/2004 S.SOMAYA Changes described below pulled by SPR EURge14694
Reference Change description
UR3029 exception when kV not active
UR1218 replaced by UR3453
UR1219 replaced by UR3454
UR1220 replaced by UR3455
New KV instability Recovery time
UR1221 replaced by UR3456
UR1222 replaced by UR3457
UR1223 replaced by UR3458
UR3459 New requirement
UR3460 New requirement
UR3461 Information
UR3463 New requirement
UR3465 New requirement
UR3467 New requirement
UR3469 New requirement
UR3468 New requirement
2318938-2DRS 1 13/10/2004 S.SOMAYA Changes described below pulled by SPR EURge15913
Reference Change description
UR3476 mAs reproducibility for Bolus
UR3477
UR3478
UR3479 Absolute mA accuracy in 120ms for Bolus
UR3480
UR3481
UR3482
UR3483
UR3484
UR3485 Chiller management and associated hardware for Zenith
UR3486
UR3487
UR3494
UR3501 LVPS400 diag for Zenith
UR3502

Author : Etienne Clemot 2318938-2DRS rev 2 3/52


GE Healthcare X-Ray Generation department Jedi 100 Vasc 1T CDRS

2318938-2DRS 2 16/05/2005 E.CLEMOT Changes described in SPR EURge25677


Reference Change description
UR3542
UR3548 New chapter for UPS management
UR3549
UR3550
Changes described in SPR EURge24839 and EURge26211
UR1723 Add access time tolerance
UR2499 Restate UR2499 to clarify

Author : Etienne Clemot 2318938-2DRS rev 2 4/52


GE Healthcare X-Ray Generation department Jedi 100 Vasc 1T CDRS

Contents

0-1.1 Goal of this document 8


0-1.2 Referenced documents 8
0-1.3 Notes 8
0-1.4 Acronyms 8
1 Functional requirements 9
1.1 Nominal power 9
1.1.1 Generator specification 10
1.1.2 Application specification 12
1.2 Worst case protocol for generator 16
1.3 Tube compatibility 16
1.3.1 Tube list 17
1.3.2 Focus (for reference only) 17
1.3.3 Heater current limitations 17
1.3.4 Grid and Bias 19
1.3.5 Tube thermal switches 19
1.3.6 Tube protection and prediction 19
1.3.7 Chiller management 20
1.3.8 Tube oil pump 21
1.3.9 Two tubes capability 21
1.3.10 UPS management 21
1.4 Access times 22
1.4.1 Zero to Cine (HP or LP) 22
1.4.2 Zero to Fluoro 22
1.4.3 Fluoro to Cine (HP or LP) 22
1.4.4 Cine (HP or LP) to fluoro 22
1.4.5 Fluoro standby to fluoro 23
1.4.6 Cine (HP or LP) to Cine (HP or LP) 23
1.5 Input power lines 23
1.5.1 Power mains 23
1.5.2 Auxiliaries mains 24
1.5.3 Tube interface mains 25
1.6 ON/OFF requirements 25
1.7 Hardware Subsystems interface 26

Author : Etienne Clemot 2318938-2DRS rev 2 5/52


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1.7.1 Bloc diagram 26


1.7.2 System cables 26
1.7.3 HV cables 27
1.7.4 Mains power cable 28
1.7.5 Auxiliaries input cable 28
1.7.6 Stator cables 28
1.7.7 Tube cable for thermal sensors 29
1.7.8 Chiller cable 29
1.7.9 InGrid cables 30
1.8 Generator exposure modes 30
1.8.1 Parameters selection and computation 30
1.8.2 Pulse-width limitations 31
1.8.3 Exposure Control 33
1.8.4 Heater current control 34
1.8.5 Rotor control 34
1.8.6 Error management and degraded Mode 34
1.9 External Subsystems interface 35
1.9.1 Communication protocol 35
1.9.2 Reset requirement 35
1.9.3 Exposure timings 36
1.10 Radiological parameters performances 39
1.10.1 kV 39
1.10.2 mAs 41
1.10.3 mA 41
1.10.4 Time 43
1.10.5 Radiation linearity 43
1.11 HV instability recovery 43
1.11.1 HV instability robustness 43
1.11.2 Generator reaction to HV instability (and recoverable errors) 43
1.11.3 Instability recovery time 44
1.11.4 Exposure abort 44
1.11.5 Error reporting and TnT logging 44
2 Uptime requirements 44
2.1 Reliability 45
2.2 Service 45
2.2.1 Calibrations 45

Author : Etienne Clemot 2318938-2DRS rev 2 6/52


GE Healthcare X-Ray Generation department Jedi 100 Vasc 1T CDRS

2.2.2 Tube/Generator auto-calibration test 45


2.2.3 Error management 45
2.2.4 Diagnostic 45
2.2.5 Insite 47
2.2.6 Historical data 47
2.2.7 Reparation 47
2.2.8 FRUs 47
2.3 Engineering and manufacturing 48
3 Safety and regulatory requirements 48
3.1 Safety functions 48
3.1.1 Exposure enable 48
3.1.2 Exposure cut-off 49
3.1.3 Temperature management 49
3.1.4 Mechanical strength 49
3.2 Regulatory 49
3.2.1 International standards 49
3.2.2 National regulations and standards 50
4 Environmental requirements 50
4.1 Dimensions (for information only) 50
4.2 Weight (for information only) 51
4.3 Mechanical configuration 51
4.4 Climate requirements 52
4.4.1 Storage and transportation 52
4.4.2 Operational conditions 52
4.5 Audible noise 52
4.6 Mechanical strength 52
4.6.1 Vibration 52
4.6.2 Acceleration 52
4.7 Packaging for Shipping and handling 52

Author : Etienne Clemot 2318938-2DRS rev 2 7/52


GE Healthcare X-Ray Generation department Jedi 100 Vasc 1T CDRS

Object Jedi CDRS for Aretha, Uroview and Liberty40 Object_typ


ID e
UR1461 About this document Heading

UR1473 0-1.1 Goal of this document Heading

UR1480 This CDRS is addressing the x-ray power unit of the Liberty program. Information

UR1490 The generator supplies the Ulysses tube in the Angio version. Information

UR2483 0-1.2 Referenced documents Heading

UR2484 X-Ray tube reference: Ulysses CDRS 2216500DRS rev0. Information

UR2485 Chiller reference: 2228054GSP rev0. Information

UR2487 Thermal simulation Algorithm: 2265230GSP Information

UR2542 Tube thermal switches: 2133581-2DDW rev A Information

UR2543 Vascular protocols: PROTOv10.xls Information

UR2548 SR requirements: JEDI- Liberty / S&R Design Verification 2347830QSRrevA Information

UR3049 JEDI CAN communication protocol: 2266121DRS Information

UR1476 0-1.3 Notes Heading

UR2445 0-1.4 Acronyms Heading

UR3052 Arms Root Mean of Squares function appled to the current. Information

UR2464 AC Alternative Current Information

UR2462 CAN Controller Area Network Information

UR2465 (C)DRS (Component) Design Requirement Specification Information

UR2449 CF Compressed Focus Information

UR2470 CPU Central Processing Unit Information

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UR2831 CTQ Critical To Quality Information

UR2463 DC Direct Current Information

UR2455 DSA Digital Subtracted Angiography Information

UR2829 DC Bus DC voltage after rectification of 3 phase mains Information

UR2452 FPS Frames Per Second Information

UR2453 FR Frame rate. Same as above. Information

UR3048 FRU Field Replace Unit Information

UR2448 FS Focal Spot Information

UR2458 GND Ground Information

UR2457 HV High Voltage Information

UR2461 HW Hardware Information

UR2451 LF Large Focus Information

UR2446 NA Not Applicable Information

UR2459 PW Pulse-Width Information

UR2450 SF Small Focus Information

UR2460 SW Software Information

UR2454 TBC To Be Confirmed Information

UR2447 TBD To Be Defined Information

UR2456 TnT Track and Trend Information

UR1481 1 Functional requirements Heading

UR1482 1.1 Nominal power Heading

Author : Etienne CLEMOT 2318938-2DRS rev 2

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UR1483 1.1.1 Generator specification Heading

UR2702 This chapter describes generator requirements only. Requirements apply to generator independently from tube association and system applications. See Information
application specification for more details.

UR2496 1.1.1.1 Peak power Heading

UR2497 Maximum peak power: 100kW (may be limited, depending on the mode or application) CTQ
Requirement

UR2498 1.1.1.2 Average power Heading

UR2992 Average power is intended to be the average power computed in a wide time frame, greater than one hour. Information

UR2499 Continuous average power: the generator is built for 3.2kW CTQ
Requirement

UR1489 1.1.1.3 Primary contacted mode Heading

UR2489 Primary contacted mode is a discontinuous mode where X-Ray pulses are obtained through kV pulses. Information

UR1484 Peak power: 100kW Requirement

UR2748 Average power: 2.6kWavg. Requirement

UR1485 kV-mA range: Requirement


… From 40kV to 125kV: 10mA up to 1000mA, below 100kWp limit

kV-mA plan:

Author : Etienne CLEMOT 2318938-2DRS rev 2

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UR1485
125
100kWpeak

100
kVpeak

60

40

10 800 1000
mA

UR2746 Maximum continuous power delivery time: 3.5s. Requirement

UR2747 Minimum rest time after maximum continuous power delivery: 5min. Requirement

UR1509 1.1.1.4 Gridded mode Heading

UR2490 Gridded mode is a discontinuous mode where X-Ray pulses are obtained through tube current pulses with permanent kV. Tube current pulses are Information
obtained with the grid function which is responsible to cut tube mA on cathode side.

UR1531 Peak power: 48kW Requirement

UR1557 kV-mA range: Requirement


… From 60kV to 120kV: 1mA to 400mA.
kV-mA plan:

Author : Etienne CLEMOT 2318938-2DRS rev 2

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UR1557

120

kVpeak

60

1 400
mA

UR1507 Average power should be at least 3.2kWavg. Information

UR1486 1.1.2 Application specification Heading

UR2703 The tube may not support all the capabilities indicated above. Information
The applications may not need all the capabilities indicated above.

UR1901 System (user) modes and generator exposure modes Information

System (user) mode Generator mode


Fluoroscopy Pulsed fluoro (gridded)
DSA (including trial shots) Cine HP (primary
contacted)
Cardiac record Cine HP (primary
contacted) or Cine LP
(gridded)

UR2494 For detailed information about generator mode characteristics, please see chapter "Generator exposure modes". Information

Author : Etienne CLEMOT 2318938-2DRS rev 2

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GE Healthcare X-Ray Generation department Jedi 100 Vasc 1T CDRS

UR3092 Fluoro may be used instead of pulsed fluoro on this document. Information

UR1493 1.1.2.1 Primary contacted mode Heading

UR2500 1.1.2.1.1 Large filament Heading

UR1497 Large filament should be set only in Cine HP. Requirement

UR1501 kV-mA capability: Information


From 80kV to 100kV: 100mA to 1000mA
From 100kV to 125kV: 100mA up to 1000mA, below 100kWp curve.
From 40kV to 80kV: 100mA up to 1000mA, below the line defined by the following boundaries
40kV, 150mA
80kV, 1000mA

kV-mA plan:

125
100kWpeak

100
kVpeak

80

40

100 150 800 1000


mA

UR1494 1.1.2.1.2 Small filament Heading

Author : Etienne CLEMOT 2318938-2DRS rev 2

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UR1503 kV-mA capability: Information


From80kV to 125kV: 10mA to 400mA, below the 48kWp curve.
From 40kV to 80kV: 10mA to 400mA, below the line defined by following boundaries
40kV, 100mA
80kV, 400mA
kV-mA plan:

125
48kWp
120

kVpeak

80

40

10 100 384 400 1000


mA

UR1529 1.1.2.1.3 Compressed filament Heading

UR1505 kV-mA capability: Information


… From 80kV to 125kV: 10mA to 200mA, below the 16kWp curve.
From 40kV to 80kV: 10mA to 200mA, below the line defined by the following boundaries
40kV, 35mA
80kV, 200mA
kV-mA plan:

Author : Etienne CLEMOT 2318938-2DRS rev 2

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GE Healthcare X-Ray Generation department Jedi 100 Vasc 1T CDRS

UR1505
125

100 16kWp
kVpeak

80

40

10 35 128 200 1000


mA

UR1488 1.1.2.2 Gridded mode Heading

UR1496 1.1.2.2.1 Large filament Heading

UR1522 Gridded mode is not available with the large filament. Information

UR1523 1.1.2.2.2 Small filament Heading

UR2793 Gridded mode shall be available with the small filament. Requirement

UR1562 kV-mA capability: Information


… From 80 to 120: 1mA to 400mA
From 60 to 80: 1mA to 400mA, below the following boundaries
60kV, 250mA
80kV, 400mA
kV-mA plan:

Author : Etienne CLEMOT 2318938-2DRS rev 2

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GE Healthcare X-Ray Generation department Jedi 100 Vasc 1T CDRS

UR1562

120

kVpeak

80

60

1 250 400
mA

UR1560 Maximum average power limits pulsed fluoro modes since Information
Pavg = kV x mAavg, and
mAavg = mA x PW x fps

UR1525 1.1.2.2.3 Compressed filament Heading

UR1526 Gridded mode is not available with the compressed filament. Information

UR1534 1.2 Worst case protocol for generator Heading

UR1536 Fluoro worst case: fluoro at 120kV, 90mA, 30fps and 10ms pulse-width (3.2kWavg). Information

UR1564 Record worst case: Cine HP at 100kVp, 1000mA, 7.5 fps and 50ms pulse-width. Information

UR1565 Worst case clinical protocol is neuro interventional protocol: alternates 4.5 minutes of record, 82.5 minutes in fluoro, 37.25 minutes instand-by and 30 Information
minutes to change patient.

UR2749 Generator shall be able to perform the worst case protocol. Requirement

UR1571 1.3 Tube compatibility Heading

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UR2806 1.3.1 Tube list Heading

UR1576 For reference. See Ulysses tube DRS. Information

UR2503 Maximum applicable high voltage: 125kV. Information

UR1611 1.3.2 Focus (for reference only) Heading

LF Large focus
size 1.0
peak power 100kW
SF Small focus
size 0.6
peak power 48kW
CF Compressed focus
size 0.3 (is the biased 0.6 focus)
peak power 16kW

UR1574 1.3.3 Heater current limitations Heading

UR1637 The generator should be able to heat SF and LF at the same time: when making X-Rays with one filament, the other one should be at pre-heat level. Requirement

UR2522 Before making X-Rays, generator heats the filament with a boost strategy. Information

UR2523 Boost time (time when the filament can be heated up-to maximum boost level) is 400ms+/-2.5%. Requirement

UR2524 After the boost, the filament goes to heat level. Information

UR2525 Heat level state shall be limited to 3 minutes if there are no X-ray demands. Requirement

UR3057 After x-rays, heat level shall be limited to 3 minutes. Requirement

UR2794 After the heat level time-out, generator shall go to pre-heat level. Requirement

UR3058 At the end of x-rays, if system software asks the Jedi to stop from being in heat state, Jedi shall go to pre-heat level. Requirement

UR1666 The generator shall have a fluoro standby state: after a fluoro is preseted, the heater should heat the filament with the fluoro stand-by level and should Requirement
be mantained after the fluoro.

Author : Etienne CLEMOT 2318938-2DRS rev 2

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UR2521 Fluoro stand-by state should be limited to 10 minutes if there are no X-ray demands. Requirement

UR2520 Heating current requirements: Requirement


Heading

SF maximum heat level 7.8A +/-2%


LF maximum heat level 7.8A +/-2%
SF maximum boost level 10.5 +/-2%
LF maximum boost level 10.5 +/-2%
Pre-heat level 2.5A +/- 3%
Fluoro stand-by level 4.5A +/- 3%

UR2795 CF heating requirement is the same as SF, since it's the same physical filament. Information

UR1572 1.3.3.1 Rotor Heading

UR2725 Run current: 3.75Arms+/-5% Requirement

UR2726 Run chopping frequency: 16kHz +/-10% Requirement

UR2728 Run current stator frequency: 130.5Hz +/-1% Requirement

UR2750 Maximum boost current is 19Arms +/-5%. Requirement

UR2751 Boost time should be less than 9.5s. Requirement

UR2734 Rotor high-speed value should be reached before end of boost time. Requirement

UR2752 Maximum break current is 15Arms +/-5%. Requirement

UR2753 Break time should be less than 17s. Requirement

UR2754 Rotation speed after break should be less than 20Hz. Requirement

UR2727 Informations on speed and motor type: Information

Stator type 3 phases, 4 poles


Rotor high-speed 120Hz to 130Hz
Rotor low-speed NA, only high-speed is
available.

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UR1707 1.3.4 Grid and Bias Heading

UR1714 CF can not be used in gridded mode. Requirement

UR2526 Rise and fall time are intended as 10% to 90% or 90% to 10% Information

UR3026 Grid function applys grid voltage on G1 (tube Cup cathode pin) only. Requirement

UR1709 Grid voltage (including ripple) in X-Ray OFF state: -3700V +/-6% Requirement

UR1751 Grid voltage in X-Ray ON state: 0+/-40V Requirement

UR1708 Maximum grid voltage rise and fall time: 150µs Requirement

UR1710 Bias function is used to reduce SF spot size to CF spot size. Information

UR3025 Bias function applys voltage on G1 (tube Cup cathode pin) and G2 (tube Tabs cathode pin). Information

UR1711 Nominal bias voltage on G2 is programmable between -1900V and -2500V. Information

UR1713 Instantanious (including ripple) bias voltage on G2 with respect to nominal is +/-8%. Requirement

UR1712 Nominal bias voltage on G1 should be the programmed value divided by 8.5. Requirement

UR2736 Instantanious bias voltage (including ripple) on G1 with respect to nominal is +/-10%. Requirement

UR1715 1.3.5 Tube thermal switches Heading

UR2527 Thermal switches: the generator has to manage two tube thermal switches: tube warm (around 33C), and tube overtemperature (around 70C). See tube Information
thermal switches referenced document for more details.

UR3060 Please refer to tube thermal switches document in referenced document chapter for more detail on thermal switches. Information

UR1717 Tube overtemperature detection: See "tube protection" below for more details. Information

UR2528 Tube warm detection: See "chiller management" below for more details. Information

UR1548 1.3.6 Tube protection and prediction Heading

UR2471 Generator implements tube thermal protection and prediction based on a reference thermal simulation algorith (see Thermal Simulation Algorithm in Information
the RTeferenced Documents)

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UR3053 Initial temperatures should be initialized to 40C. Requirement

UR3054 Generator should compute cooling during off state on boot time. Requirement

UR1543 1.3.6.1 Tube thermal protection Heading

UR1544 Generator protects the tube using a software thermal protection algorithm and monitoring the hardware tube thermal switch. Information

UR2731 Generator should compute the thermal capability of the tube using reference temperatures from the tube thermal protection algorithm and inform the Requirement
system in a percentage dimensionless scale. See tube CDRS "heat unit remaining" charts.

UR1545 Generator should inhibit exposure selection if an overtemperature is detected, either by hardware or software. Requirement

UR2467 Requirement
Generator should cut the exposure if tube overtemperature is detected, either by hardware or software.

UR2529 Generator should brake the tube rotor in case of overtemperature detection, either by hardware or software. Requirement

UR3099 Braking permits to return to a controlled state, and tube heating of one brake is negligible. Information

UR3438 The generator stores the number of times the 70°C switch is tripped up Requirement

UR2732 1.3.6.2 Tube overvoltage protection Requirement

UR1577 Generator protects the tube from overvoltage if cathode voltage to ground is below -68.5kV or the anode voltage to ground above 68.5kV by stopping Requirement
the exposure.

UR1546 1.3.6.3 Tube thermal prediction Heading

UR1578 Generator shall be able to give thermal information of the tube up to 2 times per second. Requirement

UR2730 On demand, generator shall be able to predict the final thermal state of the tube after a specified exposure (or a sequence of exposures), based on Requirement
constant input parameters (for each exposure), and inform the system if the (last) exposure can be performed.

UR2733 One minute of exposure at 7.5 fps shall be simulated in no more than 290ms. Requirement

UR2433 1.3.7 Chiller management Heading

UR2532 Please refer to Chiller DRS for chiller information. Information

UR3061 Please refer to tube thermal switches chapter above for tube thermal switches information. Information

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UR3422 Chiller is internally configured always on Information

UR2435 Good functioning of the chiller is monitored through a feedback of the chiller command. Requirement

UR3423 The generator does not drive the chiller Information

UR2755 Chiller on state is obtained with a dry relay contact. Information

UR3424 The generator monitors the 33° switch Information

UR2434 The generator monitors the chiller feedback state change. Information

UR3425 In case of transition to low state on the chiller feeback line, the Jedi raises a warning and goes to error state 3 minutes later Requirement

UR3482 The generator pulls Chiller internal datas through RS232 link. Requirement

UR3483 Jedi reports Chiller internal datas through specific error codes Requirement

UR3484 Jedi RS232 link management should adapt to Chiller versions with and without serial communication Requirement

UR3485 Internal chiller informations reported to the Jedi are : water over temperature alarm, low temperature alarm, water low flow alarm, water low level Information
alarm, water temperature.

UR3486 Number of alarm occurrences, and max temperature are stored in Jedi TnT Information

UR3487 Refer to CANCOM SRS for more details Information

UR2530 1.3.8 Tube oil pump Heading

UR2531 For tube oil pump information, please refer to tube DRS. Information

UR1718 The generator is not responsible to switch on or off the oil pump nor to supply the power. Information

UR1703 1.3.9 Two tubes capability Heading

UR1573 No two tubes capabity: the generator is able to manage only one tube. Information

UR3542 1.3.10 UPS management Heading

UR3548 Please refer to Fluoro UPS DRS (archived in server Liberty System DHF in Design Input/DRS) Information

UR3549 When DCBUS voltage goes below a DCBUS threshold, an information CAN message is sent. Requirement

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UR3550 When DCBUS voltage becomes higher than a threshold voltage, an information CAN message is sent. Requirement

UR1720 1.4 Access times Heading

UR3016 For optimizing the fluoro access times, system should preset the Jedi in fluoro mode. Information

UR3017 Zero state is when rotor is off after rotor hold time-out, or after generator boot. Information

UR1722 1.4.1 Zero to Cine (HP or LP) Heading

UR1723 Stand-by to cine access time shall be 9.5sec (-0sec,+0.5sec) (measured on CAN, from request to Jedi, to ready response of Jedi). Requirement

UR1725 Rotation: less than 9.5s Information

UR1726 Heater: less than 0.81s Information

UR1728 1.4.2 Zero to Fluoro Heading

UR1729 When rotor is on, stand-by to fluoro access time shall be less than 0.41s (from CAN request to Jedi, to mAs within accuracy specification and PW less Requirement
than demanded PW+10%).

UR3015 When rotor is off, stand-by to fluoro access time shall be less than 2s (measured on CAN, from request to Jedi to ready response of Jedi). Requirement

UR1731 Heater: less than 0.41s Information

UR1730 Rotation: 2s in case rotor is off, no wait (0s) otherwise. Information

UR1733 1.4.3 Fluoro to Cine (HP or LP) Heading

UR1734 Fluoro to cine acces time shall be less than 0.81s (measured on CAN, from request to Jedi to ready response of Jedi). Requirement

UR1735 Rotation: 0s Information

UR1736 Heater: less than 0.81s Information

UR1737 1.4.4 Cine (HP or LP) to fluoro Heading

UR1738 Cine to Fluoro access time should less than 1.0s (from CAN request to JEDI, to mAs within accuracy specification and PW less than demanded_PW + Requirement
10%)

UR1739 Rotation: 0s Information

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UR1740 Heater: less than 0.41s Information

UR3429 Note: Access time from Cine to Fluoro is mainly limited by the tube design (cooling time of large filament). Generator contribution is marginal. Information

UR3430 Worst case transition: mA demand from Cine to fluoro is decreased by a factor of 50, with fluoro at 15 FPS (lowest fluoro frame rate used by Liberty Information
system).

UR3431 Access time specification from Cine HP to Fluoro on Liberty system level is 2.1seconds. Information

UR1741 1.4.5 Fluoro standby to fluoro Heading

UR3073 Fluoro stand-by is defined in "Heater current limitations" chapter. Information

UR1742 Fluoro stand-by to fluoro access time should be less than 0.21s (from CAN request to Jedi, to mAs within accuracy specification and PW less than Requirement
demanded PW+10%).

UR1743 Rotation: 0s Information

UR1744 Heater: less than 0.21s Information

UR1745 1.4.6 Cine (HP or LP) to Cine (HP or LP) Heading

UR1746 Cine to cine acces time shall be less than 0.81s (measured on CAN, from request to Jedi to ready response of Jedi). Requirement

UR1747 Rotation: 0s. Information

UR1748 Heater: less than 0.81s Information

UR1752 1.5 Input power lines Heading

UR1753 1.5.1 Power mains Heading

UR2769 Power mains supply the inverter, responsible to generate HV, and the anode launcher to rotate the anode. Information

UR1754 1.5.1.1 Characteristics Heading

UR2756 Connnection: 3 phase with 1 ground connection, without neutral. Requirement

UR1755 Nominal voltage: from 380Vac to 480Vac. Information

UR1756 Voltage variability including daily variations: +/- 10% Information

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UR1757 Nominal frequency: 50Hz or 60Hz Information

UR2744 Line impedance should be compliant with IEC 601.2.7 Requirement

UR2534 Generator shall be pluggable without need of input voltage parametrization. Requirement

UR2737 Generator shall operate without any derating over the whole range of power mains characteristics. Requirement

UR2549 Maximum leakage current: 5 mA Requirement

UR2757 Maximum leakage current in primary defect condition: 10mA Information

UR2550 Worst case condition for leakeage currents is high mains, rotor on, heater on, HV on. Information

UR2764 Inrush current should be lower than 1000A/ms. Requirement

UR1760 1.5.1.2 Protection Heading

UR2478 Protection of mains is defined at system level. Information

UR1762 Proposed fuses: Information


Three fuses, 660V 160A, p/n 6.6URB000/160 ref N330039 (from Ferraz-Shamut) or equivalent, including cut-off characteristics.

UR1761 Proposed breaker: no proposition. TBD at system level. Information

UR1815 1.5.2 Auxiliaries mains Heading

UR1828 Auxiliary mains supplies: Information


All CPUs in the generator (Rotation, kV, mA and InGrid functions are driven by CPUs)
Fans,
filament heater current,
InGrid output voltages,
internal communication interfaces.

UR1820 1.5.2.1 Characteristics Heading

UR2758 Connection: 2 phase with ground connection. Requirement

UR1821 Nominal voltage: 230V single phase. Information

UR2763 Maximum harmonic distorsion rate should be 10% Requirement

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UR1822 Voltage variability including daily variations: +10/-15% taking into account maximum line impedance for 1kVA load. Information

UR1823 Nominal frequency: 50Hz or 60Hz Information

UR2760 Generator shall operate without any derating over the whole range of auxiliaries mains characteristics. Requirement

UR2994 Input power should come from an isolated source. Requirement

UR2761 Maximum leakeage current: 5 mA Requirement

UR2762 Worst case condition for leakeage current is heater on, InGrid on. Information

UR1816 1.5.2.2 Protection Heading

UR2479 Protection is defined at system level. Information

UR1818 Proposed fuses: 3.2A, 250V. Information

UR1826 Fuses should be placed at least in the active phase. Information

UR2765 1.5.3 Tube interface mains Heading

UR2766 Tube interface mains supply the tube and chiller interface. Information

UR2767 Output current should be below 1A. Requirement

UR2768 Proposed fuse: 3.2A, 250V. Information

UR1827 1.6 ON/OFF requirements Heading

UR1829 Sudden shut down of auxiliary, main, or tube interface supplies, do not damage the generator. Requirement

UR1832 The generator has the capability to give its internal TnT logs to the system. Information

UR688 Sudden shut down of auxiliary can limit the capabilities to give TnT logs to the system. Information

UR1897 In order to retreive Jedi internal TnT logs safely before a shut-down, the system has to retreive TnT logs 10s prior to the power off. Information

UR689 TnT logs of the generator tracks the number of spits and their type and filament aging parameters for each filament. Requirement

UR693 1.7 Hardware Subsystems interface Heading

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UR694 1.7.1 Bloc diagram Heading

UR695 Information
JEDI

HV+CABLES TO TUBE HV+


POWER TUBE ANODE
MAIN MAINS HV-
GND HV- CABLE TO INGRID INGRID TUBE CATHODE

INGRID CABLE InGrid cable

230V AUXILIARIES Phases


GND MAINS STATOR
DC_BUS –
CABLE
GND

70°C switch
TUBE
33°C switch
CAN CABLE
8
SYSTEM
RTL
INTERFACE
CHILLER Bulkhead
EXT-PS COMMAND Command
GND Feedback
TUBE INTERFACE
230V
MAINS
GND

JEDI SERIAL GALVANIC CHILLER


PORT (RS232 ) ISOLATION SERIAL PORT

All shown cables and isolation are system fourniture.

UR696 1.7.2 System cables Heading

UR697 1.7.2.1 External CAN bus cable Heading

UR1894 Cable length: less than 5m. Information

SUB-D15
Female Jedi ⇔ System Liberty names Generic names
Pin out
2 ⇔ CAN-H EXT_CAN-H
10 ⇔ CAN-L EXT_CAN-L
4 ⇐ RESET-P RTL1-P

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12 ⇐ RESET-N RTL1-N
5 ⇐ XRayCmd-P RTL2-P
13 ⇐ XRayCmd-N RTL2-N
6 ⇒ XRayOn-P RTL3-P
14 ⇒ XRayOn-N RTL3-N
7 ⇐ ExpDmd-P RTL4-P
15 ⇐ ExpDmd-N RTL4-N
1 ⇔ EXT-GND EXT-GND
8 ⇔ Not used Not used
9 ⇐ EXT-PS EXT-PS
3 Not used CAN_RTL6-P
11 Not used CAN_RTL6-N

UR1874 Not used pins should not be connected on system side. Information

UR763 EXT-PS is an external power supply. Information

UR2770 EXT-PS should be isolated from Jedi ground. Requirement

UR2771 EXT-PS range: min 12V, max 15V, maximum current 100mA. Requirement

UR3074 Use GPCP#2264092 for reference of the interface. Information

UR798 1.7.3 HV cables Heading

UR1875 Cable length: 30m or 24m. Requirement

UR2777 The cables and connectors should be 3 pin HV-cables. Requirement

UR800 Capacitance between shield and line: between 150 and 165 pF/m Requirement

UR801 Cathode HV cable connector = Federal standard Requirement

UR802 Constructors, for reference only: Information

UR805 16mm Claymount ( <=165pF/m ) (cathode cable) Information

UR804 22mm DSI ( <=165pF/m ) (anode and cathode cable) Information

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UR803 22mm cable de Lyon ( <=150pF/m ) (cathode cable) Information

UR1878 Anode HV cable connector is a miniconnector on tube side, Federal standard on Jedi side Requirement

UR2787 Generator should work without need of parametrization of HV-cable length. Requirement

UR2788 Anode and cathode cable capacitance difference should be less than 0.3nF. Requirement

UR2778 1.7.4 Mains power cable Heading

UR2779 See GPCP 2372297 for reference cable. Information

UR2780 Minimum size AWG6. Requirement

UR2781 Cable impedance should be included in line impedance as requierd by IEC 601.2.7 Requirement

UR2782 1.7.5 Auxiliaries input cable Information

UR2783 See GPCP 2186470-3 for reference cable. Information

UR2784 Minimum size AWG16. Requirement

UR2785 Minimum voltage 300V. Requirement

UR806 1.7.6 Stator cables Heading

UR807 Cable length : 30m or 24m. Information

UR808 Composed of: Information

UR809 Conductors Gauge AWG16 minimum /600Vac covered with a Polyester/alu tapes with a drain and a Jacket in PVC and an additional braid (Coverage Information
>80%) and a final Jacket in PVC.

UR810 Cores:UL758 style 1015 Information

UR811 Cable UL758 style 2463 Information

UR813 Capacitance between line and internal shielding: 670pF/m maximum Requirement

UR2772 Cables is a double shielded cable. External shield to ground. Internal shield to negative DC_Bus. Requirement

UR2773 Connections should be compatible with the GPCP reference 2298934 cable. Requirement

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UR1879 1.7.7 Tube cable for thermal sensors Heading

UR1880 Maximum cable length : 30m Requirement

UR1881 Composed of: Heading

UR1882 Conductors Gauge AWG28 minimum /300Vac with a braid and a UL Jacket Requirement

UR1885 Connector : Phoenix Information

UR2775 Connections should be compatible with the GPCP reference 2186470-5 connector. Requirement

UR1889 1.7.8 Chiller cable Heading

UR3488 1.7.8.1 command-feedback cable Heading

UR1890 Maximum cable length : 30m Information

UR1891 Composed of: Heading

UR1892 Conductors Gauge AWG18 minimum /300Vac with a braid and a UL Jacket Requirement

UR1893 Connector : Phoenix Information

UR2776 Connections should be compatible with the GPCP reference 2186470-5 connector. Requirement

UR3494 1.7.8.2 chiller serial com cable Heading

UR3496 Maximum cable length : 30m Requirement

UR3497 Chiller serial com câble will be connected on Generic interface on J3 connector Information

UR3498 S u b D 1 5 f e m a le J ED I<= > s JE DI Information


p in o u t y ste m n am e

p in 3 "=> TX
p in 5 "<= RX
p in 9 "<= > G N D _IF

UR3500 Galvanic isolation should be added in this link beetween Jedi and Chiller. This isolation, and cable are owned by the system Information

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UR819 1.7.9 InGrid cables Heading

UR820 Cable length: 30m or 24m. Requirement

UR1895 Shielded cable through 2 hybrid SubD connectors. Requirement

UR1896 The long distance internal CAN and the real time lines are twisted pairs. Requirement

UR2469 Cathode HV Cable goes to the tube through InGrid. Requirement

UR2774 Connections should be compatible with the GPCP reference 2104209-3 onInGrid side and 2104209-4 on power module side Requirement

UR1899 1.8 Generator exposure modes Heading

UR1904 1.8.1 Parameters selection and computation Heading

UR1903 Input paramaters: Requirement

Modes Input parameters Computed parameters Parameter updated


from input parameters during exposure
Fluoro FS, kV, mA, PW, FR mAs kV, mA, PW, FR
Cine LP FS, kV, mA, PW, FR mAs kV, mA, PW, FR
Cine HP FS, kV, mA, PW, FR mAs kV, mA, PW, FR

UR2012 Selectable parameter limits: Requirement

Modes kV mA PW (ms) fps


range step range step range step range step
Fluoro 60-120 0.1 1-400 0.1 2-800 0.2 1-30 NA
Cine LP 60-120 0.1 1-400 0.1 2-800 0.2 1-30 NA
Cine HP 40-125 0.1 1-1000 0.1 2-1600 0.1 0.5-30 NA

UR2491 Jedi software should limit exposure parameters as described in the above parameter limits table. Requirement

UR2492 Jedi software should limit exposure parameters depending on provided kV mA plans, for each applicable mode and focus combination (see "Nominal Requirement
power" chapter requirements). This includes maximum power limitation per mode/spot and tube low emissivity part of the kV mA plans.

UR2995 As a result of above input selectable parameters, mAs selectable parameters are: Requirement

mAs

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range step
0.002 - 320 0.0002
0.002 - 320 0.0002
0.002 - 1600 0.0001

UR2474 1.8.2 Pulse-width limitations Heading

UR2477 Minimum pulsewidth in all modes is 2ms. Requirement

UR2475 Minimum pulsewidth in Cine HP is mA dependent. Information

UR2786 Pulse-width in Cine HP definition is when kV are above 75% of demanded kV. Information

UR2476 Minimum pulsewidth in Cine HP is limited as follows: Requirement


PW (ms) > 2 (ms) + 125 (µAs) / mA

UR2789 Example1: Information


mA = max mA = 1000
PWmin = 2.125 ms

UR2790 Example2: Information


mA = min mA = 10
PWmin = 14.5 ms

UR2555 Maximum pulsewidth in Cine HP is mA and FR dependent: Information

UR2556 Maximum allowable kV step from one pulse to another is 60kV. Information

UR2557 Maximum pulsewidth is limited as follows: Requirement


PW (ms) < min(800/FR, 1000/FR-240(µAs)/mA)

UR2791 Explanation: 800/FR stands for 80% of pulse width limitation, and 1000/FR-240(µAs)/mA is for letting the kV decrease to next pulse. Information

UR2554 At low frame rates, the chart below shows these limitations: Information

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UR2554

PWmax and PWmin vs. mA


for different frame rates
800 PWmax@FR=1

700

600

PW 500
(ms)
400 PWmax@FR=2

300

200 PWmax@FR=5
100 PWmax@FR=7.5

0 PWmin@ any FR

-100

-200
0 1 2
10 10 mA 10

UR2551 At high frame rates, the chart below shows these limitations: Information

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UR2551

PWmax and PWmin vs. mA


for different frame rates

PWmax@FR=15
50
PW
(ms)
40

PWmax@FR=25
30
PWmax@FR=30

20

10

PWmin@ any FR
0
1 2
10 10 mA

UR3056 Non respect of this inputs requirement by system may lead to performance issues, degradated IQ, generator recoverable errors and generator non Information
recoverable errors.

UR2301 1.8.3 Exposure Control Requirement


Heading

Modes X-ray cut-off Exposure cut-off Pulse cut-off


mode x=expected x=expected
b=backup b=backup
ExpDmd Error XRayCmd Time mAs Error
Fluoro Gridded x b b b x b
Cine LP Gridded x b b b x b
Cine HP Primary x b b b x b
contacted

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UR2792 One exposure is composed of one or more pulses Information

UR2089 1.8.4 Heater current control Heading

UR2805 Tube current is regulated depending on generator modes: Information

Modes Mode Preparation mA loop mA loop Tube


type before within between focus
exposure pulse pulses
Fluoro Gridded No On 1st pulse Yes SF
only
Cine LP Gridded Yes On 1st pulse Yes SF
only
Cine HP Primary Yes On 1st pulse Yes LF,SF,CF
contacted only

UR1906 1.8.5 Rotor control Heading

UR2350 The Jedi provides only one speed, called high speed. Information

UR3018 The rotor shall always be runnning during X-rays at nominal speed, except for fluoro. Requirement

UR3019 The rotor shall be holded in running state after the exposure for 10 minutes. Requirement

UR3020 After the rotor time-out Jedi is in zero state (see access time specifications for access time when generator is in zero state). Information

UR1063 1.8.6 Error management and degraded Mode Heading

UR1064 Jedi reports errors and warnings to system. Requirement

UR3027 The Jedi shall handle 5 error/warning classes: Information


- class 1: warning messages.
- class 2: restartable errors.
- class 3: exposure errors.
- class 4: fatal errors.
- class 5: thermal errors spontaneously cleared by the Jedi if it detects that the usage conditions go back to normal.

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UR3028 Jedi actions on error classes: Information


- class 1: Jedi shall log the warning, and inform the system if configured to do so.
- class 2: Jedi shall recover from the error during x-ray, log the error, and inform the system if configured to do so.
- class 3: Jedi shall stop the exposure, log the error, and go to error state.
- class 4: Jedi shall stop the exposure if any, log the error, and go to error state.
- class 5: Jedi shall stop the exposure, and hold the error state until the thermal state is not normal.

UR3030 System actions on error classes: Information


- class 1: No action.
- class 2: System may use the information since performance are not guaranteed (for example on spits).
- class 3: System is able to acknowledge the error without resetting the Jedi, intervention is probably needed if the error persists on nexts exposures,
the procedure defined in troubleshooting guide should be followed.
- class 4: System is able to acknowledge the error without resetting the Jedi, intervention is probably needed, the procedure defined in troubleshooting
guide should be followed.
- class 5: System should wait the Jedi to exit from error state before restarting, intervention is probably needed, the procedure defined in
troubleshooting guide should be followed.

UR3051 Jedi does not provide any degraded mode. Information

UR1065 It's up to the system to take into account errors and choose a suitable mode in case of non blocking errors. Information

UR1066 Settable mode modes: Heading

UR1068 primary contacted modes on LF with SF out of order, Requirement

UR2809 primary contacted mode on SF with LF out of order. Requirement

UR2808 The system should clear the error to enter in degraded mode. Information

UR1070 1.9 External Subsystems interface Heading

UR1071 1.9.1 Communication protocol Heading

UR1072 See JEDI CAN communication protocol referenced document (2266121DRS). Information

UR1074 1.9.2 Reset requirement Heading

UR1075 Reset is required after the download of a new database or in case of hang up. Information

UR2562 Reset time should be less than 3s. Requirement

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UR1076 1.9.3 Exposure timings Heading

UR1077 1.9.3.1 Pulsed fluoro Heading

UR2358 Information

JEDI RTL management in pulsed Fluoro (with grid)


Exposure started XRAY_CMD starts mAs timer stops Exposure stopped
Exposure enabled
=> kV On Xray pulse Xray pulse by EXP_DMD
(CAN message)

XRAY_CMD pulse
shall be larger or
cut the pulse

RTL 4 (EXP_DMD)

kV_active threshold
kV
RTL 3 (XRayOn)

RTL 2 (XRAY_CMD)
cut off (mAs meter or timer)

DetailedActualexpParameters (exp time, mAs)


_grid_cmd_to_grid
SetAcqCmd(rotor + heater + Exposre)
SetLimitedParameters (kV, mA, time, OK.)
SetRecordParameters(kV, mA, time...)

ActualParameters (kV, mA, mAs, spits)


DetailedPulseParameters (kV,ms, mAs)

JEDIStatusError (READY for Exposure)


DetailedPulseParameters (kV,ms, mAs)

SetFineParameters(kV, mA, time...)


ConfrirmExtraParameters(FR, OK)

ConfrirmExtraParameters(FR, OK)
SetFineParameters (kV,mA, PW )
JEDI

JEDIStatusError (STANDBY)
SetExtraParameters(Frame Rate)

JEDIStatusError (HV_ON)

SetExtraParameters(Frame Rate)
CAN messages
System

NO Preparation Exposure

UR1079 1.9.3.2 Cine LP Heading

UR2359 Information

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UR2360
UR2356
UR2359


GE Healthcare

CAN messages

kV
System JEDI

SetExtraParameters(Frame Rate)

ConfrirmExtraParameters(FR, OK)

Author : Etienne CLEMOT


RTL 3 (XRayOn)
SetRecordParameters(kV, mA, time...)

_grid_cmd_to_grid
RTL 4 (EXP_DMD)

RTL 2 (XRAY_CMD)
SetLimitedParameters (kV, mA, time, OK.)

Preparation
SetAcqCmd(prep rotor + heater)

cut off (mAs meter or timer)

1.9.3.3 Cine HP
JEDIStatusError (PREP. in progress)

kV_active threshold
(CAN message)

JEDIStatusError (READY for Exposure)


Exposure enabled

SetAcqCmd(rotor + heater + Exposre)

JEDIStatusError (HV_ON)

SetFineParameters (kV,mA, PW )
=> kV On

DetailedActualPulseParam (kV, mAs, PW , spit, cut)


Xray pulse

Exposure
SetFineParameters(kV, mA, time...)
Xray pulse
Exposure started XRAY_CMD starts mAs timer stops

SetExtraParameters(Frame Rate)
cut the pulse
shall be larger or

ConfrirmExtraParameters(FR, OK)
XRAY_CMD pulse

DetailedActualPulseParam (kV, mAs, PW , spit, cut)

JEDIStatusError (READY for Exposure)

ActualParameters (kV, mA, mAs, spits)


by EXP_DMD
JEDI RTL management in cine Low power (with grid)

Exposure stopped

DetailedActualexpParameters (exp time, mAs)

2318938-2DRS rev 2
X-Ray Generation department

Heading

Information

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UR2360
JEDI RTL management in Cine High Power
Exposure enabled EXP_DMD starts XRAY_CMD starts mAs timer stops Exposure stopped
(CAN message) the exposure Xray pulse Xray pulse EXP_DMD signal
by EXP_DMD should be larger not to
cut the last pulse

XRAY_CMD pulse
shall be larger or
cut the pulse

RTL 4 (EXP_DMD)

RTL 2 (XRAY_CMD)

kV_active threshold
kV

RTL 3 (XRayOn)

cut off (mAs meter or timer)

DetailedActualexpParameters (exp time, mAs)


SetLimitedParameters (kV, mA, time, OK.)

SetFineParameters(kV, mA, time...)

ActualParameters (kV, mA, mAs, spits)


DetailedPulseParameters (kV,ms, mAs)

JEDIStatusError (READY for Exposure)


ConfrirmExtraParameters(FR, OK)
SetRecordParameters(kV, mA, time...)

DetailedPulseParameters (kV,ms, mAs)


SetAcqCmd(rotor + heater + Exposre)
ConfrirmExtraParameters(FR, OK)

SetFineParameters (kV,mA, PW )
JEDIStatusError (READY for Exposure)
SetExtraParameters(Frame Rate)

SetExtraParameters(Frame Rate)
SetAcqCmd(prep rotor + heater)
JEDI

JEDIStatusError (HV_ON)
CAN messages
System

Preparation Exposure

UR3088 1.9.3.4 Multisequence capability and skip frame strategy Heading

UR3089 The generator is capable to manage multisequence or skip frames within one same exposure (keeping EXP_DMD active), if the system informs the Information
generator about parameter changes as specified above.

UR3091 The generator is capable to manage multisequence or skip frames as two different exposures (without EXP_DMD active between the exposures), but Information
this mode may be uncompatible with desired performances because of the generator access times described in the "access times" chapter.

UR3090 In the case of multisequence or skip frames within the same exposure (keeping EXP_DMD active), then dead time between sequences should be Information
informed to generator as if it was a sudden frame-rate change ( fps = 1 / dead_time ).

UR1087 1.10 Radiological parameters performances Heading

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UR2810 Parameter performance are applicable to Cine LP and Cine HP modes. Information

UR3098 Feedback accuracies are guaranteed independently of access times. Information

UR2811 Parameter performance (except feedbacks) are applicable to fluoro, when steady state is reached (after 1s). Information

UR2823 All radiological parameters are applicable to x-ray pulses: Information

UR2821 In primary contacted mode, the pulse is defined by the kV, when above 75% of kVp. Information

UR2822 In gridded mode, the pulse is defined by the mA, when above 50% of mA. Information

UR3021 Parameter performace are applicable when the parameters demands are inside the kV-mA plans described in the application specifications section and Information
when parameter change are within maximum parameter change. When applicable, maximum parameter change are described in "change during
exposure" sub-chapters for each parameter.

UR1088 1.10.1 kV Heading

UR1089 1.10.1.1 Absolute accuracy Heading

UR2818 Information
Accuracy is the difference between system selection and the measure.

UR1091 Absolute accuracy: 3.2% CTQ


Requirement

UR1094 1.10.1.2 Relative accuracy Heading

UR2819 Relative accuracy (also called step accuracy) is the accuracy on the parameter change (parameter change is called step). Information

UR1096 Relative accuracy: 10% ± 0.1kV. Requirement

UR1097 Percentage is applied to the step. Information


For example, the system first requests 80 kV and then 82 kV. The two measured kVp in the two exposures should have a difference between 1.7kV and
2.3kV.

UR2362 1.10.1.3 Feedback accuracy Heading

UR2363 The CAN message feedback accuracy with respect to actual is 3.2%. CTQ
Requirement

UR1098 1.10.1.4 Ripple Heading

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UR3175 Not applicable Information

UR1101 1.10.1.5 Unbalance Heading

UR3148 Unbalance is defined as the max|kVanode+kVcathode| during an exposure without HV instability (| a | is absolute value of a) Information

UR2436 kV unbalance: <5% Requirement

UR1103 There is a detection of kV unbalance if the unbalance is more than 12kV. Requirement

UR1104 1.10.1.6 Rise time Heading

UR1105 The rising time from 0% to 75% of the demanded kVp should be inferior to 1.3 ms up to 125kV Requirement

UR1106 The rising time from 0% to 95% of the demanded kVp should be inferior to 1.7 ms up to 125kV Requirement

UR1109 1.10.1.7 Change during the exposure Heading

UR2817 1.10.1.7.1 Primary contacted mode Heading

UR1110 In primary contacted mode, kV change between pulses can be up to 60kV. Requirement

UR2814 1.10.1.7.2 Gridded mode Heading

UR2813 Maximum kV rise between two pulses in gridded mode: at least kVrise_max = PW(ms) x 0.25 (kV/ms) Requirement

UR2816 Maximum kV decrease in gridded mode vary depending on HV cable length and tube current. Information

UR2815 Maximum kV decrease between two pulses in gridded mode: at least kVdecrease_max = - PW(ms) x 0.25 (kV/ms) Requirement

UR1111 1.10.1.8 Overshoot Heading

UR3176 Not applicable Information

UR1199 1.10.1.9 Reproducibility Heading

UR2738 kV reproducibility is the variance in mean kV of different pulses divided by mean value of all pulses. Information

UR1200 Reproducibility: 0.5%. CTQ


Requirement

UR1113 1.10.2 mAs Heading

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UR2364 1.10.2.1 Absolute accuracy Heading

UR2739 Accuracy is the difference between system selection and the measure. Information

UR2365 Absolute pulse accuracy in gridded modes when expected cut-off cuts the pulse 5% ± 0.2µAs. CTQ
Requirement

UR3023 Absolute pulse accuracy in Cine HP when expected cut-off cuts the pulse 5% ± 0.02mAs. Requirement

UR2366 1.10.2.2 Relative accuracy Heading

UR2820 Relative accuracy (also called step accuracy) is the accuracy on the parameter change (parameter change is called step). Information

UR2367 Relative pulse accuracy in gridded modes when expected cut-off cuts the pulse 5% ± 0.2µAs. Requirement

UR3024 Relative pulse accuracy in Cine HP when expected cut-off cuts the pulse 5% ± 0.02mAs. Requirement

UR2368 1.10.2.3 Feedback accuracy Heading

UR2369 The CAN message feedback accuracy with respect to actual in gridded modes 5% ± 0.2µAs. CTQ
Requirement

UR3093 The CAN message feedback accuracy with respect to actual in primary contacted mode 5% ± 0.02mAs. CTQ
Requirement

UR2370 1.10.2.4 Reproducibility Heading

UR2740 mAs reproducibility is the variance of pulse mAs of different pulses divided by mean value of all pulses. Information

UR2371 mAs reproducibility in gridded modes when expected cut-off cuts the pulse 1% ± 0.2µAs CTQ
Requirement

UR3100 mAs reproducibility in Cine HP when expected cut-off cuts the pulse 1% ± 0.02mAs CTQ
Requirement

UR3476 mAs reproducibility should be guaranteed with mA change x3 between pulses Requirement

UR2375 1.10.3 mA Heading

UR2376 1.10.3.1 Absolute mA accuracy Heading

UR2741 Accuracy is the difference between system selection and the average measure. Information

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UR2377 Absolute mA accuracy: 10%. Requirement

UR3477 This accuracy is reached with 400ms prep+ 400ms stabilisation Information

UR2824 1.10.3.3 Change during the exposure Heading

UR2825 Maximum mA rise: +100% of starting mA value. Requirement

UR2826 Maximum mA decrease: -50% of starting mA value. Requirement

UR2827 Maximum time for mA to rise or decrease as specified: 200ms. Requirement

UR3517 1.10.3.4 Performance in Bolus conditions : Mask phase Heading

UR3478 Absolute mA accuracy, after 120ms of prep time, with mA change x2 : CTQ
-40%; +60% Requirement

UR3506 This CTQ is applicable with mA<300mA on small filament and mA<900mA on large filament. Information

UR3479 -40% fits with 20% PW margin + 20% additional dose margin. Information
+60% fits with kV control loop robustness. Refer to 5120429TDR rev1 page 7.

UR3480 Absolute mA accuracy, after 120ms of prep time, with mA change 1/2 : Requirement
mA accuracy mA range
+100%*/-70%* <100mA
+100%*,-60%** 100mA≤..<200mA
+60%**,-40%** ≥200mA

UR3525 * +100% and -70% fit with no actual limitations Information


**-60% and + 60% and -40% fit with kV control loop robustness
refer to 5120429TDR

UR3527 This requirement is applicable with mA<300mA on small filament and mA<900mA on Large filament. This requirement is not applicable to Information
compressed filament as it is not used for Bolus application.

UR3523 1.10.3.5 Performance in Bolus conditions : Injected phase Heading

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UR3481 Absolute mA accuracy, after 380ms of prep time, with mA change x1,5 or /1,5 : CTQ
-20%; +60% Requirement

UR3511 -20% fits with 20% PW margin ( No dose margin during injected phase ) Information

UR3514 +60% fits with kV control loop robustness. Refer to 51220429TDR rev1 page 7 Information

UR3526 This CTQ is applicable with mA<300mA on small filament and mA<900mA on large filament. This requirement is not applicable to compressed Information
filament as it is not used for Bolus application.

UR1175 1.10.4 Time Heading

UR2372 1.10.4.1 Absolute accuracy Heading

UR2828 Accuracy is the difference between system selection and the measure. Information

UR2374 Absolute accuracy in Cine HP: 10% above mAs = 1 mAs, 20% at lower mAs. Requirement

UR3095 Absolute accuracy in gridded modes: 10% above mAs = 0.01 mAs, 20% at lower mAs. Requirement

UR2379 1.10.4.2 Feedback accuracy Heading

UR2559 The CAN message feedback accuracy with respect to actual is 10%. CTQ
Requirement

UR1206 1.10.5 Radiation linearity Heading

UR1207 Linearity of mR versus mA is not specified at generator level. Information

UR1210 1.11 HV instability recovery Heading

UR1211 1.11.1 HV instability robustness Heading

UR1212 Generator must be able to withstand symmetrical and asymmetrical spit and arc without damage. Requirement

UR1213 1.11.2 Generator reaction to HV instability (and recoverable errors) Heading

UR3059 High voltage instabilities (spits) are recoverable errors. Information

UR1214 Every detected recoverable error (spits, kV regulation errors, ...) stops the generator. The generator is restarted after a certain time, this recovery time Requirement
follows a rule depending on the number of HV instabilities in the one second that preceeded the spit.

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UR3029 When, during an exposure, measured kV are not at the expected value, generator shall detect it and treat it as a spit, except when kV not active. Requirement

UR1215 1.11.3 Instability recovery time Heading

UR1217 This rule is: Heading

UR3453 1st spit 2ms (-1;+0)ms Requirement

UR3454 2nd spit 12ms (-1;+0)ms Requirement

UR3455 3rd spit 22ms (-1;+0)ms Requirement

UR3456 4th spit 32ms (-1;+0)ms Requirement

UR3457 5th spit 42ms (-1;+0)ms Requirement

UR3458 6th spit 52ms (-1;+0)ms Requirement

UR3459 For Liberty, This rule is not applicable to kV regulation errors when kV not active Requirement

UR3460 For Liberty, When kV not active ( during kV rise ), kV regulation are all restarted in 100µs. Requirement

UR3461 Kv regulation errors occurring when kV not active, do not affect image quality. Information

UR1226 1.11.4 Exposure abort Heading

UR1227 The exposure is aborted if there are more than 6 spits in one second. To restart exposure, it is necessary to restart the exposure procedure. Requirement

UR3463 For Liberty, kV regulation errors during kV rise are not counted for this abort. Requirement

UR3465 1.11.5 Error reporting and TnT logging Heading

UR3467 Spits and kV regulation errors are always counted in TnT Requirement

UR3469 Spits are always reported to the system Requirement

UR3468 kV regulation errors are always reported to the system, except when kV not active. Requirement

UR1228 2 Uptime requirements Heading

UR1229 2.1 Reliability Heading

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UR1230 Mean time between failures, MTBF > 50 000 hours. CTQ
Requirement

UR3075 MTBF is computed supposing that generator usage is as stated in Vascular protocols referenced document. Information

UR1238 2.2 Service Heading

UR1239 2.2.1 Calibrations Heading

UR1247 No more than three Cine HP exposures must be done for each filament in order to calibrate tube emmissivity. Information

UR2468 System can change InGrid's Bias voltage changing tube database. Requirement

UR3062 InGrid bias voltage should be configured for each tube during tube installation. Requirement

UR1246 2.2.2 Tube/Generator auto-calibration test Heading

UR1248 Auto-calibration will be done by JEDI for: tube filament aging compensation computing, DCBUS measure and cable length measure. Information

UR1249 2.2.3 Error management Heading

UR1250 The JEDI error log file can be accessed from the system through the system console (JEDI error log upload functionality) Requirement

UR1251 When an error is detected, it is sent to the system and in parallel logged in the JEDI error-log file. Requirement

UR1252 System takes this error into account to determine next acquisition mode (degraded or not). Information

UR1253 JEDI error log file contains a maximum of sixty-four logs. Each log shows the following structure: Information

Simplified Generator Error Class Error Code Data Number Date &
error Phase associated of time
code with the occurrence
error code s

UR1263 2.2.4 Diagnostic Heading

UR3076 In this document diagnostics are intended to be pass/fail software tests, with previous hardware preparation (manual intervention), unless specified. Information

UR3077 Functional checks are software tests, with previous hardware preparation unless specified, were pass/fail is decided by the field engineer. Information

UR1265 2.2.4.1 Diagnosticable functions Heading

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UR1266 Heater (no hardware preparation needed). Requirement

UR1267 Anode rotation (no hardware preparation needed). Requirement

UR1268 High voltage generation: Heading

UR1271 Inverter Short Circuit, Requirement

UR1270 Gate command funtional check, Requirement

UR1269 No load kV (HV precautions needed). Requirement

UR2381 Grid functional check (HV measurement needed). Requirement

UR3063 Bias functional check (HV measurement needed). Requirement

UR2830 Cooling fans functional check (no hardware preparation needed). Requirement

UR3501 LVPS400 ( Remote or local ) Requirement

UR3064 2.2.4.2 Diagnosed parts Heading

UR3065 Heater: Heater boards, internal cables, HV tank heating transormers, HV cables, x-ray tube. Information

UR3066 Anode rotation: Rotor board, stator cables, x-ray tube. Information

UR3067 Inverter short circuit: HV tank, inverter. Information

UR3068 Gate command functional check: gate command board. Information

UR3069 No load kV: HV tank isolation from tube and HV cables. Information

UR3070 Grid functional check: InGrid (grid function), InGrid cables, GenIF board. Information

UR3071 Bias functional check: InGrid (bias function), InGrid cables, GenIF board. Information

UR3072 Cooling fans functional check: LVPS board, LVPS to fans cables, fans. Information

UR3502 LVPS board and interconnection with other boards Information

UR1273 2.2.4.3 MTTD Heading

UR1274 Mean time to diagnostic, MTTD: 15 minutes Requirement

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UR3078 MTTD is measured performing the mean of all the diagnostics times, measured in the worst case for each diagnostic. Diagnostic is finished when the Information
failed FRU is isolated.

UR1275 2.2.5 Insite Heading

UR1276 Provisions to report event logs and TnT logs will be included in Jedi Requirement

UR1279 2.2.6 Historical data Heading

UR1281 refer to JEDI TnT specification in JEDI CAN Communication protocol Specification document for more details. Information

UR1282 2.2.7 Reparation Heading

UR1283 Mean time to repair, MTTR: 70minutes Requirement

UR3079 MMTR is the mean value of the FRU level1 replacement times, excluding diagnostic time and supposing that FRU is already on site. Information

UR3086 Means to lift the generator for installation into cabinet shall be provided by the cabinet design with appropriate fixture at generator level. Requirement

UR1284 2.2.8 FRUs Heading

UR1285 LEVEL 1: Heading

UR2384 EMC Board Information

UR2397 AC/DC 3PH HIGH POWER ASSEMBLY Information

UR2386 POWER MODULE 100 VASC Information

UR2399 HV TANK 100 VASC Information

UR2387 FILAMENT BOARD: 2 units per generator. Information

UR2388 FILAMENT BOARDs are interchangeable: no configuration is needed at install time. Requirement

UR2389 PROGRAMMED kV CONTROL PPC (system is responsible to load the right program on install time) Information

UR2390 LVPS400 Information

UR2392 ROTOR BOARD Information

UR2393 GENERIC INTERFACE Information

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UR2395 INGRID Information

UR2394 FAN SET Information

UR2396 HEATSINK Information

UR3014 FIRST AID SPARES Information

UR1311 2.2.8.1 LEVEL 2: Heading

UR2400 Level 2 FRU's should include internal cables, batteries. Information

UR3531 2.3 Engineering and manufacturing Heading

UR3536 In CineHP mode with internal frame rate control, Jedi software will be able to control the delay between reception of a technique update message, and Requirement
beginning of following X-Ray pulse, with a +/-10ms accuracy. The delay will be sent to Jedi prior to new techniques (typicall value = 120ms).

UR3537 This Requirement adresses the need of performing Bolus scenario in Engineering and Manufacturing, thus this functionality would not be used under Information
any other condition

UR1322 3 Safety and regulatory requirements Heading

UR1323 3.1 Safety functions Heading

UR1324 3.1.1 Exposure enable Heading

UR1325 This function authorizes X-Rays to start upon reception of "ExpDmd" signal from the system if the generator and tube are ready. Requirement

UR1326 Two signals are required to be active to start the exposure: Information

UR1327 An exposure enable signal has te be activated before commanding X-Rays. Information

UR1328 An exposure command X-rays signal starts the X-rays. Information

UR1329 3.1.2 Exposure cut-off Heading

UR1330 This function cuts X-Rays either when exposure command from the system is released, when a generator or tube fault occurs (error level 3 or greater), Requirement
or when mAs per pulse or time per pulse backups are reached.

UR1331 3.1.3 Temperature management Heading

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UR2407 3.1.3.1 Tube temperature management Heading

UR1332 This function inhibits X-Rays if the tube reaches overtemperature, avoiding the tube to blow. Requirement

UR2411 3.1.3.2 Generator temperature management Heading

UR1333 This function inhibits X-Rays if the tank temperature rises above 70 °C, avoiding a leakage of oil from the tank. Requirement

UR3442 This function inhibits X-Rays if the inverter temperature rises above 90°C Requirement

UR3439 The generator monitors its inverter and Tank temperature through thermal sensors Information

UR3440 The generator aborts the exposure in case the temperature max of tank or inverter is reached Information

UR3441 The generator should provide, 50 sec minimum in advance of the abort , a warning in case of Inverter or tank temperature coming close to the max Requirement
thermal limit.

UR1334 3.1.4 Mechanical strength Heading

UR2546 ‘Critical To Safety’ mechanics parts of the generator should be managed as described in S&R40 internal document. Requirement

UR1339 3.2 Regulatory Heading

UR1340 3.2.1 International standards Heading

UR1341 The generator shall be certified to meet applicable IEC standards by a notified body or test body established in the EEC. Requirement

UR1342 IEC 601.2.7 (2nd edition 1998) particular safety rules for xray generators. Requirement

UR2541 This generator has to be intended as the power unit of the X-Ray generator and not the X-Ray generator itself. Please refer to S&R IEC requirements Information
flowdown for applicable IEC 601.2.7 requirements.

UR2415 IEC 601.1.2 (2nd edition 2001) Requirement

UR2416 Including IEC 601.1.4 (programmable medical devices) Requirement

UR1346 3.2.2 National regulations and standards Heading

UR1347 3.2.2.1 USA Heading

UR1348 FDA 21 CFR part 1020.30/31 Radiological Health Diagnostic X-RAY System Requirement

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UR1349 ANSI/NFPA 70 and 99, US National Electric Code/Electrical Equipment, Health Care Facilities: certification is required at generator level. Requirement

UR1350 UL 2601.1: Xray equipment (certification required by NRTL) Requirement

UR2544 Generator should comply with Veteran Hospital standards. Requirement

UR2545 Veteran Hospital standards are customer standards, not regulatory specifications. Information

UR1351 3.2.2.2 CANADA Heading

UR1352 CSA C22.2 no 601.1-M90 : Safety of Medical Electrical Equipment. The Certification shall be provided by a standards council of Canada (SCC) Requirement
accredited laboratory such as CSA or UL.

UR1353 The CSA-C22.2 No. 0-M91 and CSA-C22.2 No. 0.4-M1982 (R1993) are regulations applicable to the design of this product, but no certification is Requirement
required at generator level.

UR1354 3.2.2.3 JAPAN Heading

UR1355 Regulation applicable to the design of this product, but no certification is required at generator level. Information

UR1356 MHW: Ministry of Health and Welfare (at system level) Information

UR1358 JIS Z 4702 standard is applicable for the design: General rules for high potential generators of medical X-Ray apparatus Requirement

UR1360 3.2.2.4 European community Heading

UR2437 MDD 93/42/EEC, Medical devices directives: CE marking Requirement

UR3050 EURATOM Directive 97/43 Requirement

UR1362 4 Environmental requirements Heading

UR1363 4.1 Dimensions (for information only) Heading

UR1364 Power Unit: H=429mm, L=395mm, l= 357mm Information

UR1365 Auxiliary Unit 1: H=429mm, L=324.5mm, l=68mm Information

UR2418 Auxiliary Unit 2: H=429mm, L=324.5mm, l=68mm Information

UR2417 ACDC/EMC Unit: H=429mm, L=320mm, l=120mm Information

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UR2423 InGrid: H=160mm, L=110mm, l=230mm Information

UR1367 4.2 Weight (for information only) Heading

UR1368 Power Unit : 60 kg Information

UR3085 Means to lift the generator for installation into cabinet (mfg or svc) shall be provided by the cabinet design with appropriate fixture at Requirement
generator level.

UR2419 Auxiliary Unit 1: 10 kg Information

UR1369 Auxiliary Unit 2: 10 kg Information

UR2420 ACDC/EMC Unit : 12 kg Information

UR2424 InGrid: 5kg Information

UR1370 4.3 Mechanical configuration Heading

UR1371 The generator is placed in a cabinet in a technical room or in the patient room (except for InGrid). This cabinet is not defined at generator level. Information

UR3080 Generator modules may be placed in the cabinet shelf or in a generator specific door module holder. Information

UR3081 Modules in a door module holder should be packaged together with the door module holder, and the door module holder delivered with the generator Requirement
to optimize mounting.

UR3082 Door module holder shall be compatible with system cabinet. Requirement

UR3084 The cabinet should let the Jedi fans enough free space to let the air flow at 0.9 times the speed of the air speed measured ouside the cabinet in free Requirement
space.

UR3083 InGrid shall be hold by the tube through the 5 pin federal standard HV connector and a bracket on the opposite side. Requirement
The bracket should be delivered with tube.

UR1372 4.4 Climate requirements Heading

UR1373 4.4.1 Storage and transportation Heading

UR1374 Temperature: -40°C to +70°C (≤ 2 days) Requirement


Humidity: 10% to 95% non-condensing
Atmospheric pressure: 650hPa to 1013hPa

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UR1375 4.4.2 Operational conditions Heading

UR1376 Temperature: +10°C to +40°C inside the cabinet. Requirement

UR2425 Humidity: operating ambient room humidity shall be between 10% and 90% non-condensing Requirement

UR2426 Atmospheric pressure: between 650hPa and 1013hPa Requirement

UR2427 Altitude: between 0m and 3600m Information

UR1377 4.5 Audible noise Heading

UR3087 These requirements shall be verified at system level since the specified values depend on other components design Information

UR1378 Jedi indexes it's fans speed on Jedi temperature to minimize Jedi noise contribution to the cabinet noise. Information

UR1379 4.6 Mechanical strength Heading

UR1380 4.6.1 Vibration Heading

UR2428 Not intended to be used into a mobile system. Requirement

UR1404 4.6.2 Acceleration Heading

UR1405 NA for generator in cabinet Information

UR2429 4.7 Packaging for Shipping and handling Heading

UR2430 The generator should be compliant with shipping and handling specification 46-316745 rev2 document. Requirement

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