Contents of this publication may not be reproduced in any form or by any means, electronic or mechanical, including photocopying and recording, or by any information storage or retrieval system without the written permission of EMD Technologies Incorporated, 400 rue du Parc, Saint-Eustache (Québec), Canada, J7R 0A1.
EPS ETA High-Voltage Generator
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HISTORY
Date Rev. Description
01.10.2019 G0 Initial Release
Specifications are subject to change without notice EMD’s High Voltage Generators are protected by one or more claims of EMD’s United States Patent Number 7,936,544, 6,738,275, 6,967,559 and 7,375,993 and EMD's European Patent 1 102 388 B1. Additional EMD patent applications pertinent to the product are pending.
Manufacturer:
EMD Technologies
400 du Parc,
Saint-Eustache, (Quebec)
Canada, J7R 0A1
MDSS GmbH
Schiffgraben 41
30175 Hannover,
Germany
Intertek Semko AB
Torshamnsgatan 43, Box 1103
SE-164 22 Kista,
Sweden
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TABLE OF CONTENTS
1.0 INTRODUCTION TO EPS ETA HIGH-VOLTAGE GENERATOR.................................................................... 4
1.1 Epsilon Platform & Configuration ............................................................................................................................... 5 1.2 Epsilon Main Features .................................................................................................................................................... 6 1.3 Options.............................................................................................................................................................................. 8
2.7 Environmental Specification ....................................................................................................................................... 27 2.8 Mechanical Data ............................................................................................................................................................ 28
3.0 COMPLIANCE INFORMATION .................................................................................................................................. 30
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1.0 INTRODUCTION TO EPS ETA HIGH-VOLTAGE GENERATOR
The EPS ETA High-Voltage generator is an Advanced High Frequency X-ray Generator designed with a unique power inverter technology and modular conception. The Generator is remarkable for its kV flatness output, an unequalled kV rise time and for its solid dielectric high-voltage unit (no oil).
Figure 1 – Typical kV Waveform.
Figure 2 – EPS ETA High-Voltage Generator illustration (covers hidden for better visualization).
Tube loading:
100 kV, 400 mA, 10 ms
Typical kV rise time: 175 µs
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1.1 Epsilon Platform & Configuration
As more power or custom features are needed, they are simply added using plug-in modules quickly inserted to the generator's main core. The latter consists of an electronic controller driving an encapsulated (oil-free) high-voltage unit. The generator comes in different configurations, best suited to conventional RAD and to the latest digital procedures. Features and options are summed up in Table 1 and described later in the text.
Table 1- Main Configurations of EPS ETA High-Voltage Generator (1)
kW AEC Hardware Options
APS ME ION S.S. Ion PhD/PMT Con/Hs Relay DAP Cb
45 2 O O O O O O O O
50 2 O O O O O O O O
55 2 O O O O O O O O
65 2 O O O O O O O O
70 2 O O O O O O O O
80 2 O O O O O O O O
(1) All configurations come with a mandatory option for rotor controller: low or dual speed anode rotation.
(2) O = Optional feature
Ion Ion Chamber Interface (2) Con/Hs Operator Console/Handswitch
S.S. Ion Solid State Ion Chamber DAP Dose Area Product
PhD Photodiode Cab Epsilon Cabinet
PMT Photomultiplier tube APS Auxiliary Power Supplies
Relay Relay Board (8 relays) ME Multi-Energy
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1.2 Epsilon Main Features
1. Extremely sharp kV waveform, with rise and fall times unparalleled in the industry, resulting in superior image quality and reduced soft radiation.
2. 380/480 VAC Universal Line Voltage Input, allowing automatic worldwide installation.
3. Solid dielectric high-voltage encapsulation.
4. Self-diagnostic methods, using redundant circuits.
5. Epsilon PC Tools configuration/diagnostic program:
- Configuration files for easy & quick set-up of generator.
- Boot loader for software update, diagnostic mode,
- Tube and generator statistics.
- HTML log with a thorough context-sensitive event descriptor.
- Second language module.
Figure 3 – Epsilon PC Tools Program.
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6. Automatic X-ray tube calibration module (Figure 4, left) with X-ray tube emission curves viewer (Figure 4, right) for backup and export.
Automatic X-ray tube calibration menu X-ray tube emission curves
7. PC serial connectivity (RS-232/CAN/USB) providing full flexibility for customer control.
8. Expansion motherboard for simplified customization through optional boards.
9. External Control Panel (CON2): A Customer can develop his own operator console (external controller, also referred to as CON2) to communicate with the generator through a bidirectional serial link using a protocol proprietary of EMD Technologies. With CON2, the generator is capable of performing multi-energy exposure mode not otherwise possible with a regular EMD’s operator console (CON1). Both CON2 and CON1 can coexist on a given Epsilon network.
If a customer develops his own console, that console shall allow the operator to operate the device safely and in complete respect of the regulatory laws in force in the country of installation. IEC 60878-5339 and/or IEC 60878-5909 symbols, presenting physiological side effects of X-rays, shall be displayed on the console. Accompanying documents of the product shall inform that the generator can be operated by trained personnel only. If the product is used in USA or in Canada, a warning text shall appear on the console with the mention that the use of the product by unauthorized individuals is prohibited.
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1.3 Options
1.3.1 Operator Console P/N 9777.101 (& Handswitch 10018.004) The Epsilon Operator Console (Figures 5, 6) provides simple control of the EPS ETA High-Voltage generator. It manages 4 configurable workstations with 3 patient sizes for more than 2000 APR exams.
Figure 5 – Epsilon Operator Console. The console includes three (3) 7-segment parameter displays and adjustment keys to quickly set up an exam. Exposure can be launched from the console or from an optional handswitch. The console also displays in a graphic screen a built-in service mode for quick diagnostic and system status feedback.
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Operator Console Keys
1. Power Off 9. mA/mAs Exposure Mode
2. Power On 10. Ion Chamber’s Fields Selection
3. RAD Switch 11. AEC Mode On/Off
4. PREP Switch 12. Parameters / Selection
5. Fault Reset 13. Graphic Screen Selections
6. Special Functions 14. AEC Density Correction
7. Workstation keys [4] 15. Patient Size [3]
8. Ion Chamber’s Film-screen Selection
Operator Console Status Indicators
A. Tube Selection F. Time Units Display
B. Focal Spot Selection G. AEC Density Bar Graph
C. System Limits H. Exposure PREP Indicator
D. Interlock Fault I. X-ray On Indicator
E. mA/mAs Display
Operator Console Screen Displays
i. kV Display; ii. mA/mAs Display; iii. Exposure Time Display; iv. Graphic Screen Display
Figure 6 – Epsilon Operator Console (description of Figure 5).
Figure 7 – Graphic screen on the operator console.
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Table 2- Operator Console Audible Alarm
Alarm conditions Tone
X-ray Emission Continuous tone (1/4 second minimum).
80 % of maximum run length elapsed Pulsed tone (2 beeps per second)
Anode H.U. over 80% Pulsed tone (2 beeps per second)
System Fault, Error 4 consecutive beeps
1.3.2 Handswitch 10018.004 (Requires EMD’s Operator Console) An optional X-ray Hand-Switch (Figure 8) provides the Epsilon operator console with a hand held push-button switch that can be extended 3.8 m (8 feet) from the operator console.
N° Qt Description
1 1 Handswitch/ cable/ connector
2 1 Handswitch console holder
3 1 Handswitch console bracket
4 1 Protective cover
5 1 Screw PHMS
6 2 Spacer
7 2 Screw SEMS
8 2 Nut Klock
Figure 8 – Handswitch Option installation on Epsilon operator console.
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1.3.3 Epsilon Cabinet P/N 10017.005 This cabinet option (Figure 9) offers mechanical and electrical enclosure to the generator using high quality aluminum panels easily assembled. The cabinet hides out the mains cable entry and affords two passageway configurations for the High-Voltage cables. 1.3.4 Two-Tube Option The 2-Tube option provides a standalone X-ray tube switch and the necessary hardware & software to drive two different X-ray tubes from a single generator. Each tube is assigned to specific workstations. Commutation time to switch tube is about 5 seconds.
EPS Generator Cabinet Two-Tube Option Cabinet
Figure 9 – Epsilon cabinet for EPS ETA Generator (left) and 2-tube option (right).
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1.3.5 Auxiliary Power Supplies The following four (4) options (P/N 11028.xxx) provide additional supplies for room interfacing. Note that with the first three (3) auxiliary power supplies, it is mandatory that the generator be supplied with 400Y/230VAC mains. The fourth option is available with 400-480 VAC mains.
Option Medical Grade Power Supply
24VDC-2.7A 150 VA Power Transformer
24VAC-150VA Mains
P/N 11028.000 400Y/230VAC
(+ Neutral) P/N 11028.001 --
P/N 11028.004 --
P/N 11028.005 400-480 VAC
1.3.6 Multi-Energy – Stepping This option allows an external controller to vary the tube loading factors during the exposure run, in-between exposures. The external controller must communicate with the generator through the use of a serial protocol (CANBUS or RS-232) proprietary to EMD Technologies Incorporated. Exposure parameters are pre-determined before beginning the run. All step changes are controlled via an external trigger and a CON2 serial protocol.
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1.3.7 Multi-Energy – Real-Time This option allows an external controller to vary the tube loading factors during the exposure run, in-between exposures. The external controller must communicate with the generator through the use of a serial protocol (CANBUS or RS-232) proprietary to EMD Technologies Incorporated. Exposure parameters vary live during the run.
Figure 10 – Typical Multi-Energy Exposures.
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1.3.8 DAP Interface P/N 10028.000
The DAP Interface option allows interfacing a VACU DAP measurement device on the generator to display, on the Epsilon Operator Console, the radiation level a patient is exposed to in radiological exams.
Figure 11 – Display of instantaneous DAP on the console’s graphic screen
1.3.9 Relay Board P/N 9932.02 This board provides eight programmable relays that can be used to control x-ray room lines as a function of the generator status (Figure 12).
(a) (b)
c)
K1-K4 : GROUP I ========== K5-K8 : GROUP II
–– : Common contact;
–– : Normally open contact ;
–– : Normally close contact
ISOLATION BARRIER
Relay board P/N 9932.02 APPLICATION NOTE:
Relays are divided in two groups; Assign each voltage type to a specific group. Do not mix AC and DC voltage switching on the same relay group. For example, use group I relays to commute line-voltage level signals and group II relays to commute low-voltage signals.
(a) Relay board mounted on its Assembly Plate;
(b) 12-Position Terminal Block (28-12 AWG).
(c) K1-K8 Relays Programmable output mode of operation.
SPDT Relays ratings:
10 A @ up to 250 VAC;
10 A @ up to 30 VDC
Figure 12 – Relay board option
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1.3.10 Power Distribution Unit (PDU) A custom power distribution unit (PDU) can be provided as per customer requirements and ancillaries. Contact EMD Technologies Incorporated for specific requirements. 1.3.11 Universal Chambers Interface Board P/N 11002.000 Consists of a plug-in board and the necessary software to perform AEC exposures on up to 3 different solid state AEC chambers. This board includes also an additional interface for a standard ion chamber.
Figure 13 – Universal Chambers Interface Board.
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2.0 TECHNICAL SPECIFICATIONS
2.1 ELECTRICAL REQUIREMENTS
2.1.1 Electrical Line Requirements Overvoltage Category II – The generator is intended to be used in “Overvoltage Category II” locations where the mains transient voltage would not be higher than 2500 Vpeak.
Three-phase Mains – The generator requires a three-phase electrical line with a protective earth ground (PE) and an optional neutral (N) wire (4 or 5 wires). Standard line regulation from no load to full load will provide full power output, at maximum kV.
Figure 14 –Types of Line Configuration. Typical Wire Size –
Maximum acceptable wire size : Based on the service breaker switch
Type of connectable conductor cross-sections
• For mains contacts
o Single or multi-stranded 2x (1 ... 25 mm²), 1x (1 ... 35 mm²)
o Finely stranded with core end processing 2x (1 ... 16 mm²), 1x (1 ... 25 mm²)
• At AWG conductors for main contacts 2x (18 ... 3), 1x (18 ... 2)
Minimum wire size (*) : 4 AWG (20 mm2) (based on NEMA XR9 for a distance of 50 ft)
Wire size depends on the length of wire. Grounding wire size (*) : 8 AWG (8 mm2) (*) Typical values as per the National Electrical Code
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2.1.2 Power Ratings
Table 3- Power Ratings and Electric Line Requirements
Mains Voltage VAC ± 10% 50/60 Hz
(3 Phases) (1)
Epsilon Configuration
Over-current Releases (A) (2)
NOMINAL ELECTRIC POWER (4)
Short Term Long Term (5)
(A)(3) (KVA) (A) (KVA)
380
EPS ETA 45 80 95 58
0.6/4.0 0.4/3.0
EPS ETA 50 100 105 68
EPS ETA 55 100 115 73
EPS ETA 65 100 135 85
EPS ETA 70 100 145 90
EPS ETA 80 100 165 105
400
EPS ETA 45 80 85 58
0.6/4.0 0.4/3.0
EPS ETA 50 100 102 68
EPS ETA 55 100 109 73
EPS ETA 65 100 124 85
EPS ETA 70 100 132 90
EPS ETA 80 100 150 102
480
EPS ETA 45 80 72 60
0.8/4.0 0.7/3.0
EPS ETA 50 100 85 70
EPS ETA 55 100 92 76
EPS ETA 65 100 105 88
EPS ETA 70 100 112 93
EPS ETA 80 100 125 105
Notes
(1) Automatic mains selection (no transformer tap configuration required). Automatic kW derating when mains voltage drops below -12% The system integrator or installer shall be responsible for providing an adequate means of disconnect from mains supply. Thermal breaker recommended.
(2) The system integrator or installer shall be responsible to provide an adequate over-current release. The values indicated in this table are suggested figures: the selected overcurrent release should have current rating versus time curve characteristics higher than the values specified. The means of disconnect must be located within the reach of the operator/service.
(3) Nominal line current values evaluated with a Mains apparent resistance of supply mains of 0.16 Ω.
(4) Add 4A to current ratings and 3kVA to kVA rating when the Auxiliary Power Supply option is installed.
(5) Values based on [Standby/Ready state] mode.
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Table 4- Mains Apparent Resistance
Mains Voltage
VAC ± 10% (3 Phases)
Epsilon
Configuration
Maximum Mains Apparent
Resistance ()
380 Volts
(50/60 Hz)
EPS ETA 45 0.20
EPS ETA 50 0.15
EPS ETA 55 0.15
EPS ETA 65 0.15
EPS ETA 70 0.12
EPS ETA 80 0.10
400 Volts
(50/60 Hz)
EPS ETA 45 0.22
EPS ETA 50 0.17
EPS ETA 55 0.17
EPS ETA 65 0.17
EPS ETA 70 0.17
EPS ETA 80 0.11
480 Volts
(50/60 Hz)
EPS ETA 45 0.32
EPS ETA 50 0.24
EPS ETA 55 0.22
EPS ETA 65 0.16
EPS ETA 70 0.16
EPS ETA 80 0.16
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2.2 Maximum Power Output
The maximum power output depends upon the power configuration (option chip) and the number of Inverters.
Table 5- Combination of x-ray tube Voltage (kV) & Current (mA) for maximum power (kW)(1)
Table 7- Accuracy and Repeatability Specifications (1)
X-ray Factor Accuracy Repeatability Conditions
kV mA mAs Time
kV(2) ± (5% + 2 kV) ± (1% + 0.25 kV) Any Any Any > 5 ms
mA ± (5% + 0.5 mA) ± (2.5% + 0.5 mA) Any Any Any > 40 ms
mAs ± (5% + 0.2 mAs) ± (2.5% + 0.2 mAs) Any Any Any > 5 ms
Irradiation time(3) ± (5% + 0.2 ms) ± (1% + 0.2 ms) Any Any Any Any
Notes:
1. Accuracy specifications were measured as per IEC 60601-2-54 requirements.
2. kV ripple as per IEC 60601-2-54 requirements.
3. Irradiation time measured as the time interval between the instant high voltage rises above 75% of its set value and the instant it falls below the same value
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2.4 Exposure Modes
2.4.1 Tube Loading Modes The generator provides single and serial tube loading with manual and AEC-controlled irradiation time.
Table 8- Available Tube Loading modes
Exposure Mode Description
Single One tube loading for a distinct switch actuation.
Multiple Repeated tube loadings for a distinct Prep switch actuation. Number of exposures depends upon the product of frame rate and run length factors. For example, a run done @ 30 f/s with a run length of 10 seconds will result in a maximum of 300 exposures.
Frame rate 7 frame rates available, programmable in service mode up to 30 f/s, with 0.05 f/s increments. Operative frame rate selected by operator, APR or digital signals.
Run length Maximum total duration of repeated tube loadings allowed by the generator for a distinct exposure switch actuation:
1, 2, 5, 10, 20, 30, 40, 50 and 60 seconds.
Note: Both operative frame rate and run length factors impact on the allowed tube kW load. The generator ensures the x-ray tube operating parameters are within safe limits.
Technique Description
3-Point Loads the tube at specific kV, mA and irradiation time factors.
2-Point Loads the tube at specific kV and mAs factors.
AEC mode
In AEC-mA
In AEC-mAs
Loads the tube …
@ specific kV & mA factors and adjustable backup time (for a given kV);
@ specific kV & backup mAs factors.
AEC-Lock Mode First exposure performed in normal AEC mode and the rest of the sequence at a fixed mAs value obtained from and equal to the first frame. The mode is actuated by a digital input.
2.4.2 AEC Mode Specifications The nominal shortest irradiation time for AEC exposure is 5 ms, at all x-ray tube current and x-ray tube voltage combinations. Maximum mAs: 600 mAs
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Six clinically significant optical density corrections are provided with the AEC mode, varying from the standardized optical density N= 1 (Figure 15).
Optical density correction (Ion chamber)
0.57 0.69 0.83 1 1.2 1.45 1.75
- 3 - 2 - 1 Normal + 1 + 2 + 3
75 % 82 % 90 % 100 % 110 % 121 % 133 %
Optical density correction (PM tube or photodiode)
Figure 15 –Useful range of optical densities in AEC mode. Ionization Chamber Interface Two ion chambers are supported on the standard generator.
• Three independent user-selectable fields (left, middle, right).
Ion Chamber Fields Film/Screen correction tables
• Three film-screen correction tables: Compensation for density relating to film-screen kV curve characteristics. Compensation ranges from – 80 % up to + 130 % of phototiming level for 12 stations between 42 kV and 133 kV.
• Other ion chamber interfaces are optional (Table 9). More AEC sensors can be interfaced, depending on the generator configuration.
Table 9- Optional Additional Ion Chamber Interfaces
Expansion boards Number/Type of AEC Chamber
Photodiode Ion Chamber Fluoro board P/N 11030.001 2 conventional ion chambers
Universal Chambers Interface Board P/N 11002.001 1 conventional ion chamber
3 solid state chambers
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Photomultiplier tube interface This option requires the PM tube board P/N 9822.01 (Figure 16). The generator provides the PM tube gain circuit adjustment using a high voltage bias supply from about -200 V to about -950 V. Photodiode interface This option requires the Photodiode Ion Chamber board P/N 11030.001 (Figure 16). One BNC type connector is used for AEC feedback input from the photodiode device.
Fluoro PMT Board P/N 9822.01
Photodiode Ion Chamber Fluoro Board P/N 11030.001
Figure 16 – Selection of Fluoro board used for AEC.
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2.5 X-Ray Tube
2.5.1 X-Ray Tube Interface Type of Tubes Class 1 B (IEC Classification). Number of Tubes One X-ray tube standard; 2-tube configuration available as an option. Models Most popular X-ray tube models are supported through a built-in X-ray tube chart. Other
X-ray tube models may be added by the installer. Tube Filaments
Focal spot number : 2
Current range : Up to 8.1 RMS amperes
Filament power : Maximum 100 watts Tube Derating
The tube factors (*) can be derated to extend its usable lifetime, to troubleshoot specific conditions or other reasons. (*) kW, kV and I filament 2.5.2 Focal Spot / Anode Speed Manual and automatic focal spot selection can be selected.
In auto focal spot selection, the filament is determined as a function of the technique kW and the anode speed. Table 10 below shows the generator algorithm for the selection of the focal spot and anode rotation speed when auto speed and auto focal spot are enabled. The anode speed is set in the workstation configuration and is not user alterable.
Table 10- Focal spot selection in Auto-Focal Spot Auto-Speed
Tube Loading Focal Spot Anode Speed
kW1
Small
Low
kW2 > kW1 High
kW3 > kW2
Large
Low
kW4 > kW3 High
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2.6 Generator I/Os Basic Specifications
2.6.1 Programmable Inputs Up to 14 programmable digital inputs are available on the generator for interfacing purposes (10 on Controller board, 2 on Fluoro board 9822.01 and 4 on Fluoro board 11030.001). All inputs are active low and use isolated diodes at their front ends. A pull-up voltage (+5VDC or +12VDC) is conveyed to the input terminals for reference. 2.6.2 Open Collector Outputs Up to 12 programmable digital outputs are available on the generator for interfacing purposes (8 on Controller board, 4 on Fluoro board 9822.01 and 2 on Fluoro board 11030.001). All outputs are open collector switches to the system DC return.
Output Reference: Maximum current in on-state: 100 mA (max. current from J14-11) Maximum voltage in off-state: 30 V 2.6.3 Cable Requirements The following cables (not supplied with the generator) are the minimum specification requirements to maintain compliance with the electromagnetic compatibility. No cable shall exceed 30.4 m (100 ft) unless in situ tests are performed to validate EMC compliance.
1) Low voltage I/O signals: (Generic type) Jacket insulated over 100% foil shield with ground drain conductor, multi-conductors type, typical 20 AWG stranded, voltage rated for the purpose.
2) X-ray tube rotor supply cable: (Generic type) Jacket insulated over 100%, foil shield with ground drain
stranded, BNC connector terminated. 4) X ray tube high voltage cables: Full braid shielded 75 kV type (between 10 to 30 meters long).
Types ll or lll as per NEMA Standard XR 7-1979 (R 1984, 1990), with locking screw available at both extremities of the cable.
5) Mains line and protective ground cables: Unshielded type, length and wire gauge must be in accordance with
applicable electrical code and local regulations.
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2.7 Environmental Specification
Table 11- Environmental Data
Factor Operation Stock & Transport
Temperature in °Celsius +10 to + 40 -25 to 70
Temperature in °Celsius / hour N/A N/A
Humidity in % (non-condensing) 30 to 75% 10 to 95%
Vibrations / Shock range in Hz 10-55 10-55
Vibrations / Shock amplitude in mm 0.153 0.153
Vibrations / Shock acceleration in G 2G / 30 minutes 2G / 30 minutes
Shock acceleration in G N/A 10
Air pressure in hPa 700 to 1060 700 to 1060
Altitude maximum in m 3000 3000
Miscellaneous Comment
Acoustic noise level : < 52 dB @ 1m
Air cooling : 200 BTU/hr in idle mode
EMC : Refer to Technical Manual, section 1.4
Ambient illuminance level : 100 lux to 1500 lux
Gas Mixture This equipment is not suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.
PRODUCT DISPOSAL
At the end of its usable lifetime, no particular action is necessary for the disposal of the product except those locally in force at the installation site. When the EPS ETA generator is fit with the 2-tube option, it includes a tank containing approximately 30 liters of dielectric oil. To dispose of this unit at the end of its service lifetime, make sure it is done in a way that respects the local environmental regulations in force.
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2.8 Mechanical Data
Dimension in mm (inches) Width Height Length Weight (*)
• Conformity is based on the equipment configured and interconnected as described in the present Technical Manual. Changes or modifications to this equipment not expressly approved by EMD Technologies Incorporated could void its conformity to applicable standards.
• Conformity to EN/IEC 60601-2-54 and EN/IEC 60601-1-3 shall be validated when the generator is integrated within a complete Medical Electrical System.
