EPS High-Voltage Generator PRODUCT SPECIFICATION

RAD/Fluoro Configuration

Copyright application © 2014 by EMD Technologies Incorporated. All rights reserved. EMD Technologies Incorporated and the EMD Technologies logo are trademarks of EMD Technologies Incorporated. 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.

RAD/Fluoro EPS High-Voltage Generator – Product Specification

TABLE OF CONTENTS

1

INTRODUCTION TO EPSILON HIGH-VOLTAGE GENERATORS ................................................................. 4 1.1 1.2 1.3 1.4

2

Epsilon Platform & Configurations ............................................................................................................................. 4 Technological Landmark ................................................................................................................................................ 5 Epsilon Main Features .................................................................................................................................................... 5 Options.............................................................................................................................................................................. 6 1.4.1 Operator Console P/N 9777.52 (& Handswitch 10018.004) ......................................................................... 6 1.4.2 TouchScreen Console (With/Without Handswitch) ....................................................................................... 9

TECHNICAL SPECIFICATIONS .................................................................................................................................. 17 2.1 Electrical Requirements ................................................................................................................................................ 17 2.1.1 Electrical Line Requirements ............................................................................................................................. 17 2.1.2 Power Ratings ....................................................................................................................................................... 18 2.2 Maximum Power Output ............................................................................................................................................. 19 2.3 Tube Loading ................................................................................................................................................................. 20 2.3.1 Loading Factors.................................................................................................................................................... 20 2.3.2 Loading Accuracy and Repeatability ................................................................................................................. 21 2.4 RAD Exposure Modes ................................................................................................................................................. 22 2.5 Fluoro Specifications..................................................................................................................................................... 25 2.5.1 Fluoro Boards ....................................................................................................................................................... 25 2.5.2 General Specifications ......................................................................................................................................... 25 2.5.3 Maximum Fluoro Entrance Exposure Rate .................................................................................................... 27 2.5.4 ABS Regulation .................................................................................................................................................... 27 2.6 X-Ray Tube .................................................................................................................................................................... 28 2.6.1 X-Ray Tube Interface .......................................................................................................................................... 28 2.6.2 Focal Spot / Anode Speed ................................................................................................................................. 28 2.7 Generator I/Os Basic Specifications.......................................................................................................................... 29 2.7.1 Programmable Inputs .......................................................................................................................................... 29 2.7.2 Open Collector Outputs ..................................................................................................................................... 29 2.7.3 Cable Requirements ............................................................................................................................................. 29 2.8 Environmental Specification ....................................................................................................................................... 30 2.9 Mechanical Data ............................................................................................................................................................ 31

3

COMPLIANCE INFORMATION .................................................................................................................................. 34

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

HISTORY

Date

Rev.

Description

01 May 2008

G0

Initial Release

May 2012

G1

New Touchscreen Operator Console New Auxiliary Power Supplies P/N 10023.004 Multi-Energy Option

23 Sept. 2014

G2

Handswitch option P/N 10018.004 (New connector RJ12) Increased Duty Cycle P/N 10005.005 (With baffle board and thermistors) Relay board Updated (P/N 9932.02) New Fluoro mode (HPPF +, P/N 10012.000) Compliance Information Updated Specifications are subject to change without notice

EMD's high voltage generator herein described is protected by one or more of the claims of EMD's United States Patent Nos. 6,738,275, 6,967,559, and 7,375,993. [Additional EMD patent applications pertinent to the product are pending].

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1 INTRODUCTION TO EPSILON HIGH-VOLTAGE GENERATORS 1.1

Epsilon Platform & Configurations

The EpsilonTM High-Voltage generator is an Advanced High Frequency X-ray Generator designed with a unique power inverter technology and modular conception. 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) highvoltage 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 below and described later in the text. Table 1- Main Configurations of EPS 45-80 High-Voltage Generator RAD

FLUORO

Conf. (1/2)

AEC

HPR

Cont.

HPF

PF

HPPF

HPPF+

EPS 45

Yes

No

Yes

Yes

Yes

No

No

EPS 50

Yes

No

Yes

Yes

Yes

No

EPS 55

Yes

No

Yes

Yes

Yes

EPS 65

Yes

No

Yes

Yes

EPS 70

Yes

No

Yes

Yes

(2)

Yes

EPS 80

O

C

Hs

Power kW

O

O

O

45

No

O

O

O

50

No

No

O

O

O

55

Yes

O

O

O

O

O

65

Yes

Yes

O

O

O

O

O

70

Yes

Yes

O

O

O

O

O

80

HPR :

High Performance Radiography

PF

Pulsed Fluoro (Standard)

HPPF+:

High Power Fluoro (Cont.)

2-T

:

HPF : Conf. (2/2)

2-T

(1)

HPPF : High Performance Pulsed Fluoro

Anode Starter

A.P.S.

Relay

Low/Dual

O

O

HPPF with up to 160/ 280 Fluoro mA

C : Cabinet Hs : Handswitch

: 2-Tube Option AEC/ABS Interface

Ion

(3 )

Yes

S.S. Ion

(4)

O

PhD

PMT

Choose 1 of 2

M.Z.

O

SPD

DAP

O

O

A.P.S. : Auxiliary Power Supplies (24 VDC; 24 VDC/24VAC or 24VAC)

PhD : Photodiode

S.S. Ion : Solid State Ion Chambers

PMT : Photomultiplier tube

SPD

: Source to Patient Dose Compensation

Relay : Relay board (8 progr. relays)

MZ : Multi-Zoom option

DAP

:

Dose Area Product

Ion : Ion chamber

Notes: (1) The second tube option provides Fluoro capability on X-ray tube number 1 only. (2) O = Option. (3) Two ion chambers are supported on all Epsilon generators. (4) Solid State ion chamber interface option does not provide ABS capability.

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

1.2

Technological Landmark

The EpsilonTM technology achieves variable frequency operation at up to 240 kHz, producing a remarkable kV flatness output and unequalled short rise time. This realization embodies important technological achievements designed with innovative power switching inverter modules and a cascaded series of high frequency power transformers embedded in a solid dielectric high voltage unit.

Tube loading: 100 kV, 400 mA, 10 ms Typical kV rise time: 175 µs

Figure 1 – Typical kV Waveform.

1.3

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. An exceptionally high efficiency which allows for less severe mains line impedance requirements. 3. 400/480 VAC Universal Line Voltage Input, allowing simple worldwide installation. 4. Self-diagnostic methods, using redundant circuits. 5. Epsilon PC Tools program: - Configuration files for easy & quick set-up of generator. - Generator database backup management. - Second language module. - Software update, tube editor, diagnostic mode, tube and generator statistics. - Export log with context-sensitive descriptor. 6. Automatic X-ray tube calibration module with X-ray tube emission curves viewer and tube calibration file for backup and export.

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

7. Solid dielectric high-voltage encapsulation. 8. PC serial connectivity providing full flexibility for customer control. 9. Expansion motherboard for simplified customization through optional boards.

1.4

Options

1.4.1

Operator Console P/N 9777.52 (& Handswitch 10018.004)

The Epsilon RF Operator Console (Figures 2, 3) provides simple control of the EPS 45-80 High-Voltage generator. It manages 6 configurable workstations with 4 patient sizes for more than 2000 APR exams. APR EXAMS:

Programmable technique chart consisting of up to 2000 fully customizable exams, stored in the Epsilon Operator Console. Every single step on the APR program leads to a new set of parameters, every time more fitted with the intended exam. This reduces the number of key strokes. The APR can be programmed to behave as a traditional APR with 7 regions per workstation, 8-10 exams per region and 3 patient sizes

Exposure buttons, optical density correction, and many feedbacks from the X-ray room and/or X-ray tube are available. Technique factors are displayed on three 7-segment parameters displays to quickly set up an exposure or visualize the APR’s exam factors. The console also includes a built-in service mode and a diagnostic mode, displayed in a graphic screen.

Epsilon Operator Console

Graphic Screen on the console

Figure 2

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

Operator Console Keys 1. Power Off 2. Power On 3. RAD Switch 4. PREP Switch 5. Fluoro Alarm Reset 6. Fluoro Reset 7. Fault Reset 8. Special Functions 9. Workstation keys Operator Console Status Indicators A. Tube Selection B. Focal Spot Selection C. System Limits D. Interlock Fault

10. 11. 12. 13. 14. 15. 16. 17. 18. E. F. G. H. I.

Ion Chamber’s Film-screen Selection mA/mAs Exposure Mode Ion Chamber’s Fields Selection AEC Mode On/Off Parameters / Selection Graphic Screen Selection keys RAD/Fluoro Mode Display AEC Density Correction Patient Size mA/mAs Display Time Units Display AEC Density Bar Graph Exposure PREP Indicator X-ray On Indicator

Operator Console Screen Displays i. kV Display;

ii. mA/mAs Display;

iii. Exposure Time Display;

iv. Graphic Screen Display

Figure 3 – Epsilon RAD/Fluoro Operator Console Layout. Document Number 10000.000.RF.G2

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

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) Pulsed tone:

Fluoro-On

Low Fluoro=> 1 beep/2 seconds High Fluoro => 1 beep/second

5-minute Fluoro elapsed

Continuous tone; can be shut off by operator at the operator console or by using a digital input to the generator.

System Fault , Error

4 consecutive beeps

HANDSWITCH P/N 10018.004 An optional X-ray Hand-Switch (Figure 4) 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. The handswitch does not allow Fluoro activation. Parts shipped or used with Hand-switch Option P/N 10018.004 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 4 –Epsilon operator console and handswitch with RJ12 connector.

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1.4.2

TOUCHSCREEN CONSOLE (WITH/WITHOUT HANDSWITCH)

Figure 5 – Epsilon TouchScreen Console P/N 13006.002-.003 The TouchScreen Console communicates with the Epsilon Generator by using the Generator Interface Box (GIB, supplied with TS) illustrated in Figure 6 below. Normally, the GIB is installed at the back of the TouchScreen computer.

Figure 6 –TouchScreen Console Interconnection with Generator thru GIB.

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

1.4.2.1 TWO-TUBE OPTION P/N 10020.001/.002 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 one or more of the six possible workstations. Commutation time to switch tube is about 5 seconds. 1.4.2.2 HIGH PERFORMANCE RADIOGRAPHY P/N 10010.000 High Performance Radiography option extends the irradiation time from 10 seconds to 63 seconds and the current by time product from 1000 mAs to 12,500 mAs. Available on EPS 80 configuration only. 1.4.2.3 HIGH PERFORMANCE PULSED FLUOROSCOPY P/N 10012.000 The High Performance Pulsed Fluoroscopy (HPPF) configuration provides the EPS High-Voltage generator with advanced performance in interventional Fluoroscopy. The configuration comes with three (3) different interventional modes : HPPF, HPPF_Plus (+) and HPPF_Extended. The first two mode provide Image Enhancement mode with a programmable enhancement factor (see table 3). The optional Extended HPPF delivers up to 280 mA for heavy Fluoro exploration. On High Performance Pulsed Fluoro configuration, the EPS High-Voltage generator is shipped with or must be equipped with : 

1 Fluoro board (P/N 9822.01 or P/N 11 030.001)



1 Increased Duty Cycle Assembly (P/N 10 005.005, including air duct board and fans)



6 Inverter boards (P/N 11 390.000).

See Table 3 next page for more details.

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

Table 3- High Performance Pulsed Fluoro Modes Normal Pulsed Fluoro

HPPF (1)

HPPF (+)(2)

E-HPPF (3)

Min. mA

16 mA

5 mA

5 mA

5 mA

Max. mA

80 mA

80 mA

160 mA

280 mA (4)

0.8 mAs

1.33 mAs

1.46 mAs

2.66 mAs

10 kW

10 kW

11 kW

20 kW

Max. Fluoro Run Time

10 minutes

10 minutes

10 minutes

20 seconds (6)

Distinct Fluoro Levels

2

2

2

1

N/A

100-400%

100-400%

N/A

Max. mAs/pulse (5)

Max. kW/pulse

Image Enhancement Max. Pulse Rate

30 p/s

Max. Duty cycle

30%

50%

50%

50%

Target Pulse Width

5.0 ms

4-10 ms

4-10 ms

4-10 ms

Number of Inverters

Minimum 3

6

6

6

Option

Option

Option

Option

Optional

Included

Included

Included

Cable Discharge (8) Increased Duty Cycle with Air Duct Board (9)

Up to 90 p/s, as per configuration

15 p/s (7)

Notes. 1. High Performance Pulsed Fluoroscopy (HPPF mode) This Pulsed Fluoro type provides a better signal-to-noise ratio because of its Image Enhancement Mode that delivers more mAs/pulse at pulse rates lower than maximum. A programmable mAs factor improves the image contrast at lower Fluoro speeds.

p/s

mAs Factor

30

x 1 (100%)

15

x 2 (200%)

2. High Performance Pulsed Fluoroscopy Plus (HPPF (+)) Interventional Pulsed Fluoroscopy mode with Fluoro mA up to 160 mA.

10

x 3 (300%)

3. Extended High Performance Pulsed Fluoro (EHPPF).

7.5

x 4 (400%)

Typical I.E. Setup

Interventional Pulsed Fluoroscopy mode with Fluoro mA up to 280 mA. Requires a dedicated Fluoro pedal.

4. E-HHPF done on large filament only.

7. Suggested value (set up in service mode).

5. Calculated for 30pps Fluoro operation

8. Refer to page 15. 9. Refer to page 16.

6. To conclude imaging only. Document Number 10000.000.RF.G2

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

1.4.2.4 HIGH POWER FLUOROSCOPY P/N 10011.000 High Power Fluoroscopy option allows up to 140 kV (instead of 125) and 20 mA (instead of 12.5) continuous Fluoro beam. Table 4- High Power Continuous Fluoro Loading Factors kV range

40 to 140 kV, in one-kV steps, with programmable kV range

mA range

0.2 to 20.0 mA

Manual Fluoro mA stations

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

1.1

1.3

1.4

1.6

1.8

2.0

2.2

2.5

2.8

3.2

3.6

4.0

4.5

5.0

5.6

6.3

7.1

8.0

9.0

10.0

11.0

12.5

14.0

16.0

18.0

20.0

mA

1.4.2.5 HIGH FRAME RATE Typically dedicated for high grade special procedures, this option allows image acquisition at up to 90 pulses per second in RAD and Fluoro. Note. To enable this feature, the HPPF option is mandatory and the Cable Discharge Unit is highly recommended. 1.4.2.6 SURFACE DOSE TRACKING OPTION Also known as “Source-Patient Distance” Dose Compensation. The generator adjusts the X-ray beam to compensate for the source-to-patient distance (SPD) when the gantry position varies during an exam. This provides constant surface dose along the full SPD span. mAs/pulse  (1/SPD)2

1.4.2.7 MULTI-ZOOM FUNCTION OPTION For imaging systems using a multi-field image intensifier only. This option provides the generator with a multiplexed AEC/ABS adjustment for 4 distinct magnification I.I. fields per workstation. Three (3) digital inputs allow the handshaking with the imaging system for the remote selection of the I.I. field during Fluoro or RAD exam. Note. For firmware 1.5.x and before, this option needs the HPPF configuration.

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

1.4.2.8 AUXILIARY POWER SUPPLIES These options provide a medical grade power supply to help supplying the peripheral interfacing. For 400Y/230VAC electrical line only:  P/N 11028.000

: Medical grade power supply rated 24VAC-150VA / 24VDC-2.7A, 65W)

 P/N 11028.001

: Medical grade power supply rated 24VDC-(2.7A), 65W.

 P/N 11028.004

: Medical grade power supply rated 24VAC-150VA.

For 400-480 VAC electrical lines:  P/N 11028.002

: Medical grade power supply rated 24VAC-350VA / 24VDC-2.7A, 65W.

 P/N 11028.005

: Medical grade power supply rated 24VAC-150VA / 24VDC-2.7A, 65W.

1.4.2.9 BASIC MULTI-ENERGY P/N 10030.000 This option allows an external controller to vary the kV and/or mA during an exposure or between exposures of a run. The external controller must communicate with the generator through the use of a serial protocol (CANBUS or RS-232) proprietary to EMD Technologies Incorporated. 

Stepping Multi-Energy: Exposure parameters are pre-determined before beginning the run. The

procedure can be applied to perform energy subtraction, or to follow a roadmap. All step changes are controlled by CON2 serial protocol. 

Real-Time Multi-Energy: Exposure parameters vary live during the run. The procedure can be used for

image stitching or for energy subtraction. The multi-energy can be synchronized or not (Figure 7) with the beginning of an exposure during the run.

Legend :

___ ___ ___

= X-ray On = kV = mA

Figure 7 – Typical Multi-Energy Exposure (Asynchronous Example).

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1.4.2.10

BASIC CABLE DISCHARGE UNIT P/N 10027.000–.001

The Cable Discharge Unit option (Figure 8) eliminates the slow cable discharging time characteristic of high kV- low mA exposures. The device acts as an electronic crowbar mechanism that delivers multiple exposures at precise exposure times using rapid rise and fall times along a broad spectrum of tube mA, on standard (no grid) X-ray tubes. This feature dramatically improves the quality of images acquired from cineradiography, digital subtraction angiography, digital radiography and Pulsed Fluoro.

(a)

(b)

Figure 8 – Cable Discharge Unit (a) and typical waveforms (b).

1.4.2.11

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 solid state AEC chambers. This board includes also an additional interface for a standard ion chamber. 1.4.2.12

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. Cumulative dose area product (DAP) would also be printed if a DAP printer is connected to the operator console. Display of instantaneous DAP on the console’s graphic screen

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1.4.2.13

INCREASED DUTY CYCLE P/N 10005.005

The Increased Duty Cycle option (Figure 9) for EPS Generators enhances the workload and patient throughput by using built-in thermostatic cooling fans and better air flow management. This option improves the Inverter board temperature management during high duty cycle applications such as High Performance Pulsed Fluoroscopy. It consists of two thermostatic fans pitching a constant air flow through an air duct board equipped with six (6) thermistors. 6 Inverter boards

Air Duct Board with 6 thermistors

Thermostatic Fans (2) inside Generator case

Fluoro Board

Figure 9 – Generator with Increased Duty Cycle installed.

1.4.2.14

RELAY BOARD P/N 9932.02

This board (Figure 10, next page) provides eight programmable relays that can be used to control X-ray room lines as a function of the generator status.

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SPDT Relays ratings: 10 A @ up to 250 VAC; 10 A @ up to 30 VDC.

(a) Relay board mounted on its Assembly Plate; (b) 12-Position Terminal Block (28-12 AWG).

(b) (a) Figure 10 – Relay board.

1.4.2.15

EPSILON CABINET P/N 10017.005/.006

This cabinet option (Figure 11) 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.

Cabinet option 10017.005

Cabinet for Generator 10017.006 (with 2-tube option)

Figure 11 – Epsilon Cabinet Options.

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2 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 Line – 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 12 –Types of Line Configuration.

Typical Wire Size – Maximum acceptable wire size : Minimum wire size (*) : Grounding wire size (*) :

0 AWG (50 mm2) 4 AWG (20 mm2) 8 AWG (8 mm2)

(*) Typical values as per the National Electrical Code.

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2.1.2

Power Ratings Table 5 – Power Ratings and Electric Line Requirements Nominal Electric Power

Mains Voltage Line Apparent Epsilon Resistance VAC ± 10% Configuration (1) ()(2) (3 Phases)

Over-current Releases (A) (3)

(A)(4)

(KVA)

EPS 45

0.22

80

85

58

EPS 50

0.17

100

102

68

EPS 55

0.17

100

109

73

400 Volts

EPS 65

0.17

100

124

85

(47-63 Hz)

EPS 70

0.17

100

132

90

EPS 80

0.11

100

150

102

EPS 90

0.11

100

170

116

EPS 100

0.09

100

200

136

EPS 45

0.32

80

72

60

EPS 50

0.24

100

85

70

EPS 55

0.22

100

92

76

480 Volts

EPS 65

0.16

100

105

88

(47-63 Hz)

EPS 70

0.16

100

112

93

EPS 80

0.16

100

125

105

EPS 90

0.16

100

145

122

EPS 100

0.12

100

165

138

Short Term

Long Term(5) (A)

(KVA)

0.8/5.0/7.0 0.7/2.4/3.4

0.8/5.0/7.0 0.7/2.4/4.1

Notes (1) Automatic mains line selection (no transformer tap configuration required). Automatic kW derating when mains line voltage drops below -12%. (2) With lower impedance lines, expect approx. 15% more current in Epsilon input current. (3) Means of adequate power disconnect is the responsibility of the system installer. Thermal breaker recommended. The over-current releases values are suggested figures only. The selected value should have current rating versus time curve characteristics higher than the ratings specified. Consult a qualified electrical contractor to comply with local electrical bylaw and site electrical installation. (4) Nominal line current values; if electric line voltage drops by minus 10%, the input current will then increase by 10%. (5) Values based on [Standby/Ready state/ Fluoro] mode.

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2.2

Maximum Power Output Table 6– Combination of x-ray tube voltage and x-ray tube current for maximum power(1) Tube Current (mA) EPS 100 (6 Inverters) EPS 90 (6 Inverters) EPS 80 (6 Inverters) EPS 70 (5 Inverters) EPS 65 (5 Inverters) EPS 55 (4 Inverters) EPS 50 (4 Inverters) EPS 45 (3 Inverters)

200

250

320

400

500

630

800

1000

Nominal kV

150

150

150

150

150

127

113

100

kW

30

37

48

60

75

80

90.4

100

Nominal kV

150

150

150

150

150

127

112

90

kW

30

37

48

60

75

80

89.6

90

Nominal kV

150

150

150

150

150

127

100

80

kW

30

37

48

60

75

Nominal kV

150

150

150

150

140

kW

30

37

48

60

Nominal kV

150

150

150

150

kW

30

37

48

60

Nominal kV

150

150

150

137

kW

30

37

48

Nominal kV

150

150

150

kW

30

37

48

Nominal kV

150

150

140

kW

30

37

80 111

87

70 130

103

81

65 110

87

55 125

100

79

50

112

90

45

(1) Nominal electric power outputs (in kW) are given for 100-ms tube loading time.

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2.3

Tube Loading

2.3.1

Loading Factors Table 7– Loading Factors as per EPS Generator Configurations EPS Generator Configurations

X-ray Factor kV

45-kW

50/55-kW

65/70-kW

80/100-kW

40 – 150

40 – 150

40 – 150

40 – 150

1-kV steps; X-ray tube voltages according to available electrical powers. mA

10 – 500

10 – 630

10 – 800

10 – 1000

____________ 25% increment steps (up to 21 stations) _______________ 10;

12.5;

16;

20;

100;

125;

160;

200; 250;

mAs

25;

0.4 – 630

32;

40;

50;

320; 400; 500;

0.4 – 1000

63;

80;

630;

800;

1000.

0.4 – 1000

0.4 – 1000

______________ 25% increment steps (35 stations) _________________ 0.4;

0.5;

0.63;

0.8;

1.0;

1.25;

1.6;

2.0;

2.5;

3.2;

4.0;

5.0;

6.3;

8.0;

10;

12.5;

16;

20;

25;

32;

40;

50;

63;

80;

100;

125;

160;

200;

250;

320;

400;

500;

630;

800;

1000.

Time (s)

0.001 – 10

0.001 – 10

0.001 – 10

0.001 – 10

___________ 25% increment steps (41 stations, below in ms) ______________ 1.0;

1.25;

1.6;

2.0;

2.5;

3.2;

4.0;

5.0;

6.3;

8.0;

10;

12.5;

16;

20;

25;

32;

40;

50;

63;

80;

100;

125;

160;

200;

250;

320;

400;

500;

630;

800;

1600;

2000;

2500;

3200;

4000;

5000;

6300;

8000;

1000; 1250;

Document Number 10000.000.RF.G2

10000.

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

2.3.2

Loading Accuracy and Repeatability Table 8– Accuracy and Repeatability Specifications (1) X-ray Factor

Accuracy

Repeatability

kV(2)

± (5% + 2 kV)

mA mAs Irradiation time(3)

Conditions kV

mA

mAs

Time

± (1% + 0.25 kV)

Any

Any

Any

> 5 ms

± (5% + 0.5 mA)

± (2.5% + 0.5 mA)

Any

Any

Any

> 40 ms

± (5% + 0.2 mAs)

± (2.5% + 0.2 mAs)

Any

Any

Any

> 5 ms

± (5% + 0.2 ms)

± (1% + 0.2 ms)

Any

Any

Any

Any

Notes: 1. Accuracy specifications were measured at 100 kV at half the nominal power with 35 feet (10.7 m) H.V. cable between generator and X-ray tube. 2.

0.5 kV ripple at 100 kV, 250 mA with 50' (15.25 m) High-Voltage cables.

3.

Irradiation time represents the time interval between the instant that the tube potential has risen for the first time to a value of 80% and the instant at which it finally drops below the same value.

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

2.4

RAD Exposure Modes

The generator provides single and serial tube loading with manual and AEC-controlled irradiation time (Table 9). Cardiac, vascular and other exposure modes are available as optional configurations (Table 10). Table 9– Available Tube Loading modes Exposure Mode

Description

Single

One tube loading for a distinct switch actuation.

Division mode

Multiple exposures (2 to 8) with a single press and hold of the PREP pedal and multiple press-release cycles of the RAD pedal.

Multiple

Repeated tube loadings for a distinct Prep switch actuation. Number of exposures depends upon the product of frame rate and run length factors (see below). 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

Up to 7 frame rates available. Operative frame rate selected by operator, APR or digital signals. Service programmable up to 30 f/s, with 0.05 f/s increments.

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 (*)

Loads the tube …

In AEC-mA

@

specific kV & mA factors and adjustable backup time (for a given kV);

In AEC-mAs

@

specific kV & backup mAs factors

AEC-Zero Point AEC-Lock Mode

@ Automatic kV (as a function of Fluoro kV) & adjustable backup mAs factor. In multiple exposure mode only; Loads the tube as in normal AEC mode for the first frame, and uses the measured mAs factor for the remaining tube loadings.

See also “AEC Mode Specification”, next page.

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

Table 10– Optional Tube Loading modes Exposure Mode

Description

Cardiac-kW

Exposures performed using constant kW algorithm (variable mA). This method intends to improve the image contrast. Exposures performed using constant mA algorithm (variable kW). This method intends to reduce the patient dose. Automatic serial exposure mode that combines pre-selected parameters with auto-kV mode and AEC feedback.

Cardiac-mA D.S.A./D.A. AEC-Falling Load Multi-Energy

In AEC-mAs exposure, the tube is loaded at a higher tube current value, after which the mA drops as the exposure proceeds. 3-point exposure mode in which kV and/or mA factor(s) can vary live during the exposure to produce a multi-level waveform output. kV & mA requests are externally controlled using a serial protocol proprietary to EMD Technologies.

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 Optical density adjustment Six clinically significant optical density corrections are provided with the AEC mode, varying from the standardized optical density N= 1 (Figure 13). 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 13 –Useful range of optical densities in AEC mode.

Ionization Chamber Interfaces Two ion chambers are supported on the standard generator. 

Three independent user-selectable fields (left, middle, right).

Ion Chamber Fields

Document Number 10000.000.RF.G2

Film/Screen correction tables

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RAD/Fluoro EPS High-Voltage Generator – Product Specification



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 11). More AEC sensors can be interfaced, depending on the generator configuration. Table 11– 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

Photomultiplier tube interface This option requires the PM tube Fluoro board P/N 9822.01. 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 Fluoro board P/N 11030.001. One BNC type connector is used for ABS/AEC feedback input from the photodiode device.

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

2.5

Fluoro Specifications

2.5.1

Fluoro Boards

Two Fluoro boards are available to interface Fluoro (Figure 14): the generator requires one of them to perform Fluoro. The selection of Fluoro board is done as a function of the room ABS device The board is installed in the Expansion Basket.

Fluoro PMT Board P/N 9822.01

Photodiode Ion Chamber Fluoro Board P/N 11030.001

Figure 14 – Exclusive selection of Fluoro boards.

2.5.2

General Specifications Table 12– Continuous Fluoro Loading Factors kV range

40 to 125 kV, in one-kV steps, with programmable kV range

mA range

0.2 to 12.5 mA

Manual Fluoro mA stations

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

1.1

1.3

1.4

1.6

1.8

2.0

2.2

2.5

2.8

3.2

3.6

4.0

4.5

5.0

5.6

6.3

7.1

8.0

9.0

10.0

11.0

12.5 mA

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

Table 13– Pulsed Fluoro Loading Factors kV range

40 to 125 kV, in one-kV steps, with programmable kV range

mA range

16 to 80 mA peak

Pulse rate

7 pulse rates available, from 0.25 to 30 p/s (0.25 p/s increments);

Minimum mAs

0.08 mAs /pulse @ 40 kV station; 0.25 mAs/pulse @ 125 kV

Maximum mAs

Adjustable up to 5.0 mAs/pulse as a function of the maximum pulse rate operation Up to 0.80 mAs per pulse Up to 1.6 mAs per pulse Up to 3.2 mAs per pulse Up to 4.8 mAs per pulse

@ @ @ @

30 p/s maximum 15 p/s maximum 7.5 p/s maximum 5.0 p/s maximum

For 30 p/s maximum pulse rate operation: mA

16

18

20

22

25

28

32

36

40

44

50

56

64

72

80

ms

5.0

5.0

5.0

5.0

5.0

5.0

5.0

5.0

5.0

5.0

5.0

5.0

5.0

5.0

5.0-10

mAs

0.08

0.09

0.10

0.11

.125

0.14

0.16

0.18

0.20

0.22

0.25

0.28

0.32

0.36

.4 -.8

FOCAL SPOT

Continuous Fluoro :

Small filament (large filament if small filament opens);

Pulsed Fluoro

Small or large filament, depending of Fluoro configuration.

:

TIMER

Fluoro timer cumulated during the Fluoro exam. The timer is displayed and reset at the Epsilon operator console.

DUAL FLUORO

Allows both Pulsed and Continuous Fluoro at the Epsilon console. This mode is not compatible with High Performance Pulsed Fluoro and High Power Fluoro.

ANODE SPEED

Low (normal), high or RAD anode speed rotation.

SHUTDOWN

Fluoro automatic shutdown after 10 minutes of uninterrupted Fluoro.

ALARMS

3 distinct alarms during Fluoro (Table 14). Table 14– Audible Alarm during Fluoro Exposure Alarm

Tone

Fluoro Low-Level “ON”

1 beep/2 seconds; can be disabled by Field Engineer @ installation.

Fluoro High-Level “ON”

1 beep/second.

5-minute Fluoro elapsed

Document Number 10000.000.RF.G2

Continuous tone; can be shut off by operator at the operator console or

by using a digital input to the generator.

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

2.5.3

Maximum Fluoro Entrance Exposure Rate

Before using the generator clinically, the maximum Fluoroscopic entrance exposure rate must be adjusted by the installer. If the adjustment procedure is omitted at initial installation, Fluoro will be done using the minimum mA value only. Two (2) Fluoro pedals are supported, one for Low (or Normal) Fluoro level, the second for High Fluoro level. The maximum Fluoro entrance exposure rate of each Fluoro level must be adjusted by the Field Engineer at installation time before doing Fluoro clinically. 2.5.4

ABS Regulation

Four (4) service programmable kV/mA tracking curves are provided to improve contrast during Fluoro image stabilization.

ABS3

ABS2

ABS1

ABS4

Figure 15 – kV-mA Tracking ABS Curves.

Table 15– Fluoro board as per type of Fluoro and ABS device Continuous Fluoroscopy Photomultiplier tube: Board P/N 9822.01 Photodiode: Board P/N 11030.001 CCD camera or Flat Panel: P/N 11030.001

Pulsed Fluoroscopy Photomultiplier tube: Board P/N 9822.01 Photodiode: Board P/N 11030.001

Ionization chamber:

Board P/N 9822.00 or P/N 11030.001

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

2.6

X-Ray Tube

2.6.1

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 can be derated to extend its usable lifetime, to troubleshoot specific conditions or other reasons. 2.6.2

Focal Spot / Anode Speed

Manual and automatic focal spot selection can be selected in RAD. In auto focal spot selection, the filament is determined as a function of the technique kW and the anode speed. Table 16 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 16– Focal spot selection in Auto-Focal Spot Auto-Speed Tube Loading

Focal Spot

kW1 kW2 > kW1 kW3 > kW2 kW4 > kW3

Document Number 10000.000.RF.G2

Anode Speed

Low Small

High Low

Large High

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

2.7 2.7.1

Generator I/Os Basic Specifications Programmable Inputs

12 or 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.

2.7.2

Open Collector Outputs

10 or 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:

2.7.3

Maximum current in on-state: 100 mA (max. current from J14-11) Maximum voltage in off-state: 30 V

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 conductor, multi-conductors type. 14 AWG minimum stranded, rated 600 volts minimum. 3) Phototube & photodiode cables : RG59 type, 90 % shielded minimum recommended, internal conductor stranded, BNC connector terminated. 4) X ray tube high voltage cables: Full braid shielded 100 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. 6) Mains line and protective ground cables : Unshielded type, length and wire gauge must be in accordance with applicable electrical code and local regulations.

Document Number 10000.000.RF.G2

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

2.8

Environmental Specification Table 17– 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

0.153

0.153

2G / 30 minutes

2G / 30 minutes

N/A

10

700 to 1060

700 to 1060

3000

3000

Vibrations / Shock amplitude in mm Vibrations / Shock acceleration in G Shock acceleration in G Air pressure in hPa Altitude maximum in m 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. If the EPS generator is fit with the optional cable discharge unit (high-end Cardiac configurations) or 2-tube unit, these units contain approximately 30 liters of dielectric oil. When comes the time to dispose of one or both units, it must done in a way that respects the local environmental regulations in force.

Document Number 10000.000.RF.G2

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

2.9

Mechanical Data Table 18– Mechanical Data Dimensions (mm)

Crate / Box

Weight (kg)

Length

Width

Height

Standalone in carton crate

890

590

1120

74 -110*

Standalone

578

441

492

64 -75*

Standalone with cabinet

768

472

812

79 - 90*

With Biplane combination

768

472

1624

180

With 2-Tube option & cabinet

768

472

1268

113 - 124*

With Cable Discharge option & cabinet

768

472

1268

130 - 136*

(*) Approximately, as a function of power configuration and options.

Figure 16 – Optional Operator Console Dimensions.

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

Dimension in mm (inches)

Width

Height

Length

Weight (*)

441 (17 3/8)

492 (19 3/8)

578 (22 3/4)

64-75 kg (140-165 lb)

” .. with cabinet

472 (18 1/2)

806 (32)

776 (30 1/2)

79-90 kg (175-200 lb)

” .. with 2-Tube option & cabinet

472 (18 1/2)

1268 (50)

768 (30 1/4)

113-124 kg (250-275 lb)

” .. with Cable Discharge option

472 (18 1/2)

1268 (30 1/4)

768 (30 1/4)

125-136 kg (275-300 lb)

Generator (standalone)

(*) Approximately, as a function of power configuration.

Figure 17 – Epsilon Dimensions and Center of Gravity (C.G.).

Document Number 10000.000.RF.G2

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

Front view Cabinet dimensions in mm (inches)

Side view Weight: Approximately 33 lb. (15kg)

Figure 18 – Cabinet Dimensions.

Document Number 10000.000.RF.G2

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RAD/Fluoro EPS High-Voltage Generator – Product Specification

3 COMPLIANCE INFORMATION Epsilon High-Voltage Generator complies with the following standards and regulations: Table 19– Regulation and Standards (1/2) Market

Type

Standard

Canada

Safety

CAN/CSA C22.2 No. 60601.1 :2008 & CAN/CSA C22.2 No. 60601.2.54 :2011

USA

Safety

AAMI ES 60601-1 :2005 & IEC 60601-2-2-54 :2009

Health This product complies with DHHS radiation performances of 21 CFR, Subchapter J in effect at date of manufacturing. Europe

EN 60601-1 : 2006 & IEC 60601-2-54 :2009

International

IEC 60601-1 : 2005 & IEC 60601-2-54 :2009

The EPS generator also complies with the standards listed below. Table 19– Regulation and Standards (1/2) Market

Type

Standard

Canada

Safety

CAN/CSA C22.2 No. 601.1M90 & CAN/CSA C22.2 No. 601.2.7-01

USA

Safety

UL 60601-1 :2003 & IEC 60601-2-7 :1998

Europe

EN 60601-1 :1990 + A1 :1993 + A2 : 1995 & EN 60601-2-7 :1998.

Important Notice 

The 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 to EN/IEC 60601-2-7 shall be validated when the generator is integrated within a complete Medical Electrical System.

End of document

Document Number 10000.000.RF.G2

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