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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. emd technologies a HEICO company
Transcript

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.

~ emd technologies a HEICO company

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 2/34

TABLE OF CONTENTS

1 INTRODUCTION TO EPSILON HIGH-VOLTAGE GENERATORS ................................................................. 4

1.1 Epsilon Platform & Configurations ............................................................................................................................. 4 1.2 Technological Landmark ................................................................................................................................................ 5 1.3 Epsilon Main Features .................................................................................................................................................... 5 1.4 Options.............................................................................................................................................................................. 6

1.4.1 Operator Console P/N 9777.52 (& Handswitch 10018.004) ......................................................................... 6 1.4.2 TouchScreen Console (With/Without Handswitch) ....................................................................................... 9

2 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

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 3/34

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].

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 4/34

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) 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 below and described later in the text.

Table 1- Main Configurations of EPS 45-80 High-Voltage Generator

Conf. (1/2)

RAD FLUORO 2-T

(1) C Hs

Power kW AEC HPR Cont. HPF PF HPPF HPPF+

EPS 45 Yes No Yes Yes Yes No No O O O 45

EPS 50 Yes No Yes Yes Yes No No O O O 50

EPS 55 Yes No Yes Yes Yes No No O O O 55

EPS 65 Yes No Yes Yes Yes O O O O O 65

EPS 70 Yes No Yes Yes Yes O O O O O 70

EPS 80 Yes O (2) Yes Yes Yes O O O O O 80 HPR : High Performance Radiography HPPF : High Performance Pulsed Fluoro C : Cabinet

PF : Pulsed Fluoro (Standard) HPPF+ : HPPF with up to 160/ 280 Fluoro mA Hs : Handswitch

HPF : High Power Fluoro (Cont.) 2-T : 2-Tube Option

Conf. (2/2)

Anode Starter

A.P.S. Relay AEC/ABS Interface

SPD DAP Ion

(3 S.S. Ion

(4) PhD PMT M.Z.

Low/Dual O O Yes) O Choose 1 of 2 O O O

A.P.S. : Auxiliary Power Supplies

(24 VDC; 24 VDC/24VAC or 24VAC)

Relay : Relay board (8 progr. relays)

Ion : Ion chamber

PhD : Photodiode

PMT : Photomultiplier tube

MZ : Multi-Zoom option

S.S. Ion : Solid State Ion Chambers

SPD : Source to Patient Dose Compensation

DAP : Dose Area Product

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.

I

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 5/34

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.

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.

Tube loading:

100 kV, 400 mA, 10 ms

Typical kV rise time: 175 µs

kV

100 ...

' I I • t

80 ' ·········(········(·······1·········j········· ........... . 100 kV l ,

60 ········· •··•·····•······· 400 mA ····•··-i-········i··•······ ····· 10 ms : '

' . . ' '

= ••·······•··· i ........ · ........ 11 J ......•• O L __ .J.... __ ~--~--:-'-'.:--::-::---::.,;:.._---:':::-- Time

2.0 4.0 6.0 8.0 10 12 (ms) 0

W,S. 1 WS2

r::rr,....ws P'OtldWS

P"Enotilofbro roe1ur:wo

..,,, "'" ,_,.c..,--------­

RadT,,gger

.... ~1,mrno1-~ ..... =--.-, ~_:i

E~Swilehes

"'"""" PJ12!Conl•J P'J2(lb;,roPMTJ

E"l)OUeTJIPl,C r,_ r,­rAEckv-m1.-eu,.;1,, rAECkV-8Uf1¥1.1 rAECZeroPoril

.. F/R2 r;t1'5

F/R3 i;710

FJFU r:;re

F/R'!i F7•

F/R6 p2

F/R7 pS...;.

-~~------, Fielc!El\atllt

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,::i ..... l'_,

[~~ [lbw~ ~:' ~

r-,-...,,-------------------~r-- 1, ...

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 6/34

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.

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

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

BR RiRJ IDUil un un un

---••

- --·--·- -------------

a a a a

ANODE H.U . = 0 %

216 mA 11 ms NEXT

FIRST LEVEL

Workstation

APR Selection

Run Setup

Anode Heat Units

Fluoro mAs Timer Info

+ 30 F/S t IC RUN LENGTH

+ 30 SEC t IC El ANODE

H.U. = 7% IC '®)' 1.lf MIN.

ANODE NEXT IC BRAKE 2 2nd LEVEL

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 7/34

Operator Console Keys

1. Power Off 10. Ion Chamber’s Film-screen Selection

2. Power On 11. mA/mAs Exposure Mode

3. RAD Switch 12. Ion Chamber’s Fields Selection

4. PREP Switch 13. AEC Mode On/Off

5. Fluoro Alarm Reset 14. Parameters / Selection

6. Fluoro Reset 15. Graphic Screen Selection keys

7. Fault Reset 16. RAD/Fluoro Mode Display

8. Special Functions 17. AEC Density Correction

9. Workstation keys 18. Patient Size

Operator Console Status Indicators E. mA/mAs Display

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

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.

E, F ---.. ----cm~-~anri------cm~~ ; - [ [_ ii -"--~====----==:_J----'

14 -----'u---------'-n _ u _ g-'--g-----'---------n

9 I I I

L_ - - - -- - -- -- -- - - - - - - -- -- - -- -- -- -- -- -- - __ !

iii 1

=-a a a • I

l ~ • ~ U~l~N

·:.:.~ ::.=.~~~=~=::.: _ _, _____ 1'---- ...... -'~': ... -· 7 6 5 I H 4

2

a 15

iv a l a l a

G 16

3

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 8/34

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)

Fluoro-On Pulsed tone: 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.

Epsilon Operator Console

- t> "(),' --_ G,

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 9/34

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.

(

0 0

~ emd recJmolog,es epsilon , __ _ -~ 1 0%HU - ---

rm GIB INTERCONNECTION GEN Ready ON OFF

Power

I I ~ TO Conil• , ~ GfNlRATOll

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 10/34

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.

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 11/34

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)

Max. mAs/pulse (5) 0.8 mAs 1.33 mAs 1.46 mAs 2.66 mAs

Max. kW/pulse 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

Image Enhancement N/A 100-400% 100-400% N/A

Max. Pulse Rate 30 p/s Up to 90 p/s, as per configuration 15 p/s (7)

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

Cable Discharge (8) Option Option Option Option

Increased Duty Cycle

with Air Duct Board (9) Optional Included Included Included

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.

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

3. Extended High Performance Pulsed Fluoro (EHPPF).

Typical I.E. Setup

p/s mAs Factor

30 x 1 (100%)

15 x 2 (200%)

10 x 3 (300%)

7.5 x 4 (400%)

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

4. E-HHPF done on large filament only. 5. Calculated for 30pps Fluoro operation 6. To conclude imaging only.

7. Suggested value (set up in service mode). 8. Refer to page 15. 9. Refer to page 16.

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 12/34

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.

I I

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 13/34

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).

Tek JL l!]Ro-, M Pos: 2.000s SAVE/REC .j,

Action

1~

lllilllllll!IJ

Recall From

R mll Setup D

.... , . CH2 1.00V M 500ms

CH3 200mV 10- Feb-0912:45 1()1,

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 14/34

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.

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

(a) (b)

100 kV, 32 mA, 12.5 ms

r I t-

'•-, - :· lf+-H t-----+ t- + ------,>-- ~ .---t

: I -~'-- : _: :_ Rise time

le ss t ha n 0.6 ms

- With Cable D isch a r ge Unit - Without Cable D isch a r ge Unit

a HIGH LEVEL a a t 15 P/5 t a

ANODE

a H.U. = 11% a 11. 57

a mGy * m2

a NEXT

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 15/34

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.

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.

Air Duct Board with 6 thermistors

Thermostatic Fans (2) inside Generator case

Fluoro Board

6 Inverter boards

0 0

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 16/34

(a) (b)

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).

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.

I I I I I I I I

Q I

o/

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 17/34

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 : 0 AWG (50 mm2) Minimum wire size (*) : 4 AWG (20 mm2) Grounding wire size (*) : 8 AWG (8 mm2)

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

3 Phase WYE

._ ____ L2 \ ~ -:ta~lation

---------- L3 -I i---------- (N) 1-----------?

3 Phase DELTA, balanced earth or floating

------- Ll

) X- ray installation

r-------- L2

----------- L3 -----------?

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 18/34

2.1.2 Power Ratings

Table 5 – Power Ratings and Electric Line Requirements

Mains Voltage

VAC ± 10%

(3 Phases) (1)

Epsilon Configuration

Line Apparent Resistance

()(2)

Over-current Releases

(A) (3)

Nominal Electric Power

Short Term Long Term(5)

(A)(4) (KVA) (A) (KVA)

400 Volts

(47-63 Hz)

EPS 45 0.22 80 85 58

0.8/5.0/7.0 0.7/2.4/3.4

EPS 50 0.17 100 102 68

EPS 55 0.17 100 109 73

EPS 65 0.17 100 124 85

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

480 Volts

(47-63 Hz)

EPS 45 0.32 80 72 60

0.8/5.0/7.0 0.7/2.4/4.1

EPS 50 0.24 100 85 70

EPS 55 0.22 100 92 76

EPS 65 0.16 100 105 88

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

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.

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 19/34

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) 200 250 320 400 500 630 800 1000

EPS 100 (6 Inverters)

Nominal kV 150 150 150 150 150 127 113 100

kW 30 37 48 60 75 80 90.4 100

EPS 90 (6 Inverters)

Nominal kV 150 150 150 150 150 127 112 90

kW 30 37 48 60 75 80 89.6 90

EPS 80 (6 Inverters)

Nominal kV 150 150 150 150 150 127 100 80

kW 30 37 48 60 75 80

EPS 70 (5 Inverters)

Nominal kV 150 150 150 150 140 111 87

kW 30 37 48 60 70

EPS 65 (5 Inverters)

Nominal kV 150 150 150 150 130 103 81

kW 30 37 48 60 65

EPS 55 (4 Inverters)

Nominal kV 150 150 150 137 110 87

kW 30 37 48 55

EPS 50 (4 Inverters)

Nominal kV 150 150 150 125 100 79

kW 30 37 48 50

EPS 45 (3 Inverters)

Nominal kV 150 150 140 112 90

kW 30 37 45

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

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 20/34

2.3 Tube Loading 2.3.1 Loading Factors

Table 7– Loading Factors as per EPS Generator Configurations

X-ray Factor EPS Generator Configurations

45-kW 50/55-kW 65/70-kW 80/100-kW

kV 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; 25; 32; 40; 50; 63; 80;

100; 125; 160; 200; 250; 320; 400; 500; 630; 800; 1000.

mAs 0.4 – 630 0.4 – 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;

1000; 1250; 1600; 2000; 2500; 3200; 4000; 5000; 6300; 8000; 10000.

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 21/34

2.3.2 Loading Accuracy and Repeatability

Table 8– 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 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.

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 22/34

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 (*)

In AEC-mA

In AEC-mAs

AEC-Zero Point

Loads the tube …

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

@ specific kV & backup mAs factors

@ Automatic kV (as a function of Fluoro kV) & adjustable backup mAs factor.

AEC-Lock Mode 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.

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 23/34

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.

Cardiac-mA Exposures performed using constant mA algorithm (variable kW). This method intends to reduce the patient dose.

D.S.A./D.A. Automatic serial exposure mode that combines pre-selected parameters with auto-kV mode and AEC feedback.

AEC-Falling Load In AEC-mAs exposure, the tube is loaded at a higher tube current value, after which the mA drops as the exposure proceeds.

Multi-Energy

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 Film/Screen correction tables

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 24/34

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.

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 25/34

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

JS

l3A

J4 J3B

3f'l 1L,;J JlO

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 26/34

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

by using a digital input to the generator.

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 27/34

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.

Figure 15 – kV-mA Tracking ABS Curves.

Table 15– Fluoro board as per type of Fluoro and ABS device

Continuous Fluoroscopy Pulsed Fluoroscopy

Photomultiplier tube: Board P/N 9822.01 Photodiode: Board P/N 11030.001 CCD camera or Flat Panel: P/N 11030.001

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

ABS1

ABS2

ABS3

ABS4

c( 20 E ,1,,1 Ill 00 ~ .... 0

::e BO C

60

40

20

80 100 120 kV

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 28/34

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 Anode Speed

kW1

Small

Low

kW2 > kW1 High

kW3 > kW2

Large

Low

kW4 > kW3 High

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 29/34

2.7 Generator I/Os Basic Specifications 2.7.1 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: Maximum current in on-state: 100 mA (max. current from J14-11) Maximum voltage in off-state: 30 V 2.7.3 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 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.

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 30/34

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

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. 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.

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 31/34

2.9 Mechanical Data

Table 18– Mechanical Data

Crate / Box Dimensions (mm)

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.

333 mm ~ -----( 13118" )-----~

Weight: 3.6 kg (8 lb)

77mm ( 3")

55mm _ _ _ ( 2 1/8")

276mm ( 10 7/8 ")

'

0

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 32/34

Dimension in mm (inches) Width Height Length Weight (*)

Generator (standalone) 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)

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

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

TOP VIEW i---578 (22.75)---------i

r 1111111111111111 II I II II I I I c;.;;> 11 U 111111 U 11111 H 1111111

111111 11 111111 11 11 111 11 111 __,_____l-----¼+-ll-+,l---lHl--lH-+-l¼+¼--ll---ll-+-- 1111

MOUNTING 11 U 111111 U 111111 U I 111 BRACKETS

IIUIIIIIIUII II IIUH 111 ctf2> ¢ 11 U 111111 U 111111 U 111 11

C.G.

441 (17.375)

410 (16.125)

----616 (24.25)----

SIDE VIEW

492 (19.375)

----------635 (25) ----------

0

1111111111111111111111111111 ·Ill • •

0

i-------- 299 (11.78) -------i C.G.

182 (7.15)

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 33/34

Front view Side view

Cabinet dimensions in mm (inches) Weight: Approximately 33 lb. (15kg)

Figure 18 – Cabinet Dimensions.

472 (18 5/8)

]•••••••••••••••••••( •••••••••••••••••••(

D

l••••••••••••••••••• I ••••••••••••••••••• 1

Q)

806 (31 3/4)

389 (15 5/16)

-----~ II, -+---------'-I

aa• moa• mo o • ma o ama a • mo o • mam• moa ao• m• a • m• a • ma o am• a • moa• mam• mo• D• DDD •• OD •••• o • a •••••• a ••••••• a •••••••••••••• a •••• a • a ••••••• • o • o •• o •••••••• aa ••• a • aa •••• a •

l ,------- 712.8 (28 1/16)

____ ,rl 27 (1) - I---

RAD/Fluoro EPS High-Voltage Generator – Product Specification

Document Number 10000.000.RF.G2 34/34

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, Sub-chapter 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


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