JEDI Generator SRS
JEDI Generator SRS
JEDI Generator SRS
Note: Before using this document, make sure it is the latest revision. Access the PDM system
to verify the current version.
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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
Contents
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
UR3052 Arms Root Mean of Squares function appled to the current. Information
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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.
UR2497 Maximum peak power: 100kW (may be limited, depending on the mode or application) CTQ
Requirement
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
UR2489 Primary contacted mode is a discontinuous mode where X-Ray pulses are obtained through kV pulses. Information
kV-mA plan:
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UR1485
125
100kWpeak
100
kVpeak
60
40
10 800 1000
mA
UR2747 Minimum rest time after maximum continuous power delivery: 5min. Requirement
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.
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UR1557
120
kVpeak
60
1 400
mA
UR2703 The tube may not support all the capabilities indicated above. Information
The applications may not need all the capabilities indicated above.
UR2494 For detailed information about generator mode characteristics, please see chapter "Generator exposure modes". Information
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UR3092 Fluoro may be used instead of pulsed fluoro on this document. Information
kV-mA plan:
125
100kWpeak
100
kVpeak
80
40
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125
48kWp
120
kVpeak
80
40
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UR1505
125
100 16kWp
kVpeak
80
40
UR1522 Gridded mode is not available with the large filament. Information
UR2793 Gridded mode shall be available with the small filament. Requirement
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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
UR1526 Gridded mode is not available with the compressed filament. Information
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
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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
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
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.
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UR2521 Fluoro stand-by state should be limited to 10 minutes if there are no X-ray demands. Requirement
UR2795 CF heating requirement is the same as SF, since it's the same physical filament. Information
UR2734 Rotor high-speed value should be reached before end of boost time. Requirement
UR2754 Rotation speed after break should be less than 20Hz. Requirement
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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
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
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
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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UR3054 Generator should compute cooling during off state on boot time. Requirement
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
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.
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
UR3061 Please refer to tube thermal switches chapter above for tube thermal switches information. Information
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UR2435 Good functioning of the chiller is monitored through a feedback of the chiller command. Requirement
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
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
UR1573 No two tubes capabity: the generator is able to manage only one tube. Information
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
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
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
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
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
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%)
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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
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%).
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
UR2769 Power mains supply the inverter, responsible to generate HV, and the anode launcher to rotate the anode. Information
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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
UR2550 Worst case condition for leakeage currents is high mains, rotor on, heater on, HV on. Information
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UR1822 Voltage variability including daily variations: +10/-15% taking into account maximum line impedance for 1kVA load. Information
UR2760 Generator shall operate without any derating over the whole range of auxiliaries mains characteristics. Requirement
UR2762 Worst case condition for leakeage current is heater on, InGrid on. Information
UR2766 Tube interface mains supply the tube and chiller interface. Information
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
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UR695 Information
JEDI
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
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
UR2771 EXT-PS range: min 12V, max 15V, maximum current 100mA. Requirement
UR800 Capacitance between shield and line: between 150 and 165 pF/m Requirement
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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
UR2781 Cable impedance should be included in line impedance as requierd by IEC 601.2.7 Requirement
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.
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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UR1882 Conductors Gauge AWG28 minimum /300Vac with a braid and a UL Jacket Requirement
UR2775 Connections should be compatible with the GPCP reference 2186470-5 connector. Requirement
UR1892 Conductors Gauge AWG18 minimum /300Vac with a braid and a UL Jacket Requirement
UR2776 Connections should be compatible with the GPCP reference 2186470-5 connector. Requirement
UR3497 Chiller serial com câble will be connected on Generic interface on J3 connector Information
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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UR1896 The long distance internal CAN and the real time lines are twisted pairs. Requirement
UR2774 Connections should be compatible with the GPCP reference 2104209-3 onInGrid side and 2104209-4 on power module side Requirement
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
UR2786 Pulse-width in Cine HP definition is when kV are above 75% of demanded kV. Information
UR2556 Maximum allowable kV step from one pulse to another is 60kV. Information
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
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@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.
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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
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UR1065 It's up to the system to take into account errors and choose a suitable mode in case of non blocking errors. Information
UR2808 The system should clear the error to enter in degraded mode. Information
UR1072 See JEDI CAN communication protocol referenced document (2266121DRS). Information
UR1075 Reset is required after the download of a new database or in case of hang up. Information
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UR2358 Information
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)
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
UR2359 Information
…
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UR2360
UR2356
UR2359
…
GE Healthcare
CAN messages
kV
System JEDI
SetExtraParameters(Frame Rate)
ConfrirmExtraParameters(FR, OK)
_grid_cmd_to_grid
RTL 4 (EXP_DMD)
RTL 2 (XRAY_CMD)
SetLimitedParameters (kV, mA, time, OK.)
Preparation
SetAcqCmd(prep rotor + heater)
1.9.3.3 Cine HP
JEDIStatusError (PREP. in progress)
kV_active threshold
(CAN message)
JEDIStatusError (HV_ON)
SetFineParameters (kV,mA, PW )
=> kV On
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
Exposure stopped
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)
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
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 ).
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UR2810 Parameter performance are applicable to Cine LP and Cine HP modes. Information
UR2811 Parameter performance (except feedbacks) are applicable to fluoro, when steady state is reached (after 1s). 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.
UR2818 Information
Accuracy is the difference between system selection and the measure.
UR2819 Relative accuracy (also called step accuracy) is the accuracy on the parameter change (parameter change is called step). Information
UR2363 The CAN message feedback accuracy with respect to actual is 3.2%. CTQ
Requirement
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UR3148 Unbalance is defined as the max|kVanode+kVcathode| during an exposure without HV instability (| a | is absolute value of a) Information
UR1103 There is a detection of kV unbalance if the unbalance is more than 12kV. Requirement
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
UR1110 In primary contacted mode, kV change between pulses can be up to 60kV. Requirement
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
UR2738 kV reproducibility is the variance in mean kV of different pulses divided by mean value of all pulses. Information
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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
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
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
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
UR2741 Accuracy is the difference between system selection and the average measure. Information
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UR3477 This accuracy is reached with 400ms prep+ 400ms stabilisation Information
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
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.
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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.
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
UR2559 The CAN message feedback accuracy with respect to actual is 10%. CTQ
Requirement
UR1212 Generator must be able to withstand symmetrical and asymmetrical spit and arc without damage. Requirement
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
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
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
UR3467 Spits and kV regulation errors are always counted in TnT Requirement
UR3468 kV regulation errors are always reported to the system, except when kV not active. Requirement
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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
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
UR1248 Auto-calibration will be done by JEDI for: tube filament aging compensation computing, DCBUS measure and cable length measure. Information
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
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
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UR2830 Cooling fans functional check (no hardware preparation needed). Requirement
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
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
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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.
UR1276 Provisions to report event logs and TnT logs will be included in Jedi Requirement
UR1281 refer to JEDI TnT specification in JEDI CAN Communication protocol Specification document for more details. Information
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
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
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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
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
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.
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UR1332 This function inhibits X-Rays if the tube reaches overtemperature, avoiding the tube to blow. Requirement
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.
UR2546 ‘Critical To Safety’ mechanics parts of the generator should be managed as described in S&R40 internal document. Requirement
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.
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
UR2545 Veteran Hospital standards are customer standards, not regulatory specifications. Information
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.
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
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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.
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.
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UR2425 Humidity: operating ambient room humidity shall be between 10% and 90% non-condensing Requirement
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
UR2430 The generator should be compliant with shipping and handling specification 46-316745 rev2 document. Requirement
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