EPS RF Product Specification.G3
EPS RF Product Specification.G3
a HEICO company
PRODUCT SPECIFICATION
RAD/Fluoro Configuration
Copyright application © 2019 by EMD Technologies Incorporated. All rights reserved. EMD Technologies
Incorporated and the EMD Technologies Incorporated 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 – 10000.000-RAD/Fluoro.G3
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
02 July 2019 G3 European Authorized Representative added
Options updated (Section 1.3)
New regulatory requirements and standard references (Section 3)
Specifications are subject to change without notice
EMD’s High Voltage Generators are protected by one or more claims of EMD’s United States Patent Number
7,936,544, 6,738,275, 6,967,559 and 7,375,993 and EMD's European Patent 1 102 388 B1. Additional EMD patent
applications pertinent to the product are pending.
Manufacturer:
CE:
0413
EMD Technologies MDSS GmbH Intertek Semko AB
400 du Parc, Schiffgraben 41 Torshamnsgatan 43, Box 1103
Saint-Eustache, (Quebec) 30175 Hannover, SE-164 22 Kista,
Canada, J7R 0A1 Germany Sweden
TABLE OF CONTENTS
kV
100
--------..------··············
. ' .
80 ............... . ·········,·-··---··-,·········,-········ '
· ····-----1····
Tube loading:
I + I I
100 kV
100 kV, 400 mA, 10 ms 60 .......... . · ····· 400 mA ········i········· '·········;····
10 ms
... :
. .. '
. ·
'
Typical kV rise time: 40 ·········:········ ---------:---------l·--------1--------- --------•----
175 µs . .
.... .... ...
20 ................ . . -- -......... -. --... -., .. -.. -- -. ~. -. -.. -. - -- ........ -. -.
EPS 45 S – S O S O O O O O O 45
EPS 50 S – S O S O O O O O O 50
EPS 55 S – S O S O O O O O O 55
EPS 65 S – S O S O O O O O O 65
EPS 70 S – S O S O O O O O O 70
EPS 80 S O S O S O O O O O O 80
S = Standard O = Option
I
HPR : High Performance Radiography HPPF : High Performance Pulsed Fluoro ME : Multi-Energy
PF : Pulsed Fluoro (Standard) HPPF+: HPPF with Fluoro mA up to 160/ 280 Cb : Cabinet
APS : Auxiliary Power Supplies PhD : Photodiode S.S. Ion : Solid State Ion Chambers
Relay: Relay board (8 progr. relays) PMT : Photomultiplier tube SPD : Source to Patient Dose Compensation
Ion : Ion chamber MZ : Multi-Zoom option DAP : Dose Area Product
(1) The second tube option provides Fluoro capability on X-ray tube number 1 only.
(2) Two ion chambers are supported on all Epsilon generators.
2. 380/480 VAC Universal Line Voltage Input, allowing automatic worldwide installation.
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r DSA lnpUI
6. Automatic X-ray tube calibration module (Figure 3, left) with X-ray tube emission curves viewer (Figure 3,
right) for backup and export.
Tube Calibfation
Tube c-bVie
EnterSl!MCeMode r
r ""' Tube Emission adaptation
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~ation•completedr'Calbationdone").
AUTION
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9. External Control Panel (CON2): A Customer can develop his own operator console (external controller, also
referred to as CON2) to communicate with the generator through a bidirectional serial link using a protocol
proprietary of EMD Technologies. With CON2, the generator is capable of performing multi-energy
exposure mode not otherwise possible with a regular EMD’s operator console (CON1). Both CON2 and
CON1 can coexist on a given Epsilon network.
If a customer develops his own console, that console shall allow the operator to operate the device safely and
in complete respect of the regulatory laws in force in the country of installation. IEC 60878-5339 and/or IEC
60878-5909 symbols, presenting physiological side effects of X-rays, shall be displayed on the console.
Accompanying documents of the product shall inform that the generator can be operated by trained personnel
only. If the product is used in USA or in Canada, a warning text shall appear on the console with the mention
that the use of the product by unauthorized individuals is prohibited.
1.3 Options
1.3.1 Operator Console P/N 9777.102 (& Handswitch 10018.004)
The Epsilon RF Operator Console (Figures 4, 5) provides simple control of the EPS High-Voltage generator. It
manages 6 configurable workstations with 4 patient sizes for more than 2000 APR exams.
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I I\
CAUTION
X-RAYS
7 6 5 H 4 3
The console includes three (3) 7-segment parameter displays and adjustment keys to quickly set up an exam.
Exposure can be launched from the console or from an optional handswitch. The console also displays in a graphic
screen a built-in service mode for quick diagnostic and system status feedback.
.-----Workstation---~
Wall Bucky Wall Bucky
SKULL APR Selectio n
PEDIATRIC
Run Set up -
t 30 F/S
RUN LENGTH
t IC
ANODE Anode -
t
El
30 SEC
ANODE
t IC
H.U. = 0% Heat Uni ts H.U. = 7%
216 mA Fluor o_
'®' 1.~ MIN.
IC
11 ms mAs Time r
APR NEXT Info ANODE NEXT
BRAKE 2 IC
FIRST LEVEL 2nd LEVEL
•
Continuous tone; can be shut off by operator at
5-minute Fluoro elapsed the operator console or by using a digital input to
the generator.
An optional X-ray Hand-Switch (Figure 7) 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.
N° Qt Description
Handswitch/ cable/
1 1
connector
Handswitch console
2 1
holder
Handswitch console
3 1
bracket
4 1 Protective cover
5 1 Screw PHMS
6 2 Spacer
7 2 Screw SEMS
8 2 Nut Klock
This cabinet option (Figure 8) 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.
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 dedicated workstations, with Fluoro
capability performed on Tube n° 1 only. Commutation time to switch tube is about 5 seconds.
/:::::::
·····
Figure 8 – Epsilon cabinet for EPS Generator (left) and 2-tube option (right).
Available on EPS 80 configuration only. 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.
Notes :
1. Exposures done in HPR (more than 10s or more than 1000 mAs) are possible in 3-point exposure
mode only. Exposures longer than 10 s are limited to 42 kW.
2. In this mode, all exposures are conditional to the limitations of the tube manufacturer specifications.
The High Performance Pulsed Fluoroscopy (HPPF) configuration provides the EPS High-Voltage generator with
advanced performance in interventional Fluoroscopy. The configuration comes win three (3) different options (see
Table 3 next page for details):
i./ HPPF;
ii/ HPPF (+);
iii/ E-HPPF (Extended HPPF)
The first two options provide Image Enhancement mode with a programmable enhancement factor.
The E-HPPF delivers up to 280 mA for heavy Fluoro exploration.
On High Performance Pulsed Fluoro configuration, the EPS High-Voltage generator must be equipped with:
• 1 Increased Duty Cycle Assembly P/N 10005.007, including air duct board and fans
Min. mA 16 mA 5 mA 5 mA 5 mA
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
Notes.
1. High Performance Pulsed Fluoroscopy: Pulsed Fluoro with a
programmable Image Enhancement Mode that provides a better signal-
to-noise ratio. This mode allows to deliver a constant average mAs at lower Typical I.E. Setup
Fluoro speeds. p/s mAs Factor
30 x 1 (100%)
2. HPPF (+); Interventional Pulsed Fluoroscopy mode with Fluoro mA up
to 160 mA. 15 x 2 (200%)
4. E-HHPF done on large filament only. 6. Suggested value (set up in service mode).
High Power Fluoroscopy option extends the range of Continuous Fluoro at up to 140 kV and 20 mA.
Typically dedicated for high grade special procedures, this option allows image acquisition at up to 90 pulses per
second in RAD and Fluoro.
For imaging systems using a multi-field image intensifier only. This option allows up to four (4) different AEC and
ABS adjustment per workstation and for Fluoro.
The Biplane configuration (Figure 9) consists of two Epsilon High-Voltage Generators enclosed in one EPS cabinet
assembly, each generator being connected to a distinct x-ray tube. Both planes operated from a single operator console
attached to the master plane.
The biplane configuration allows to make synchronized exposures on the two planes simultaneously, or on any single
planes individually, master and slave.
SLAVE PLANE
MASTER PLANE
This option allows an external controller to vary the tube loading factors during the exposure run, in-between
exposures. The external controller must communicate with the generator through the use of a serial protocol
(CANBUS or RS-232) proprietary to EMD Technologies Incorporated. Exposure parameters are pre-determined
before beginning the run. All step changes are controlled via an external trigger and a CON2 serial protocol.
This option allows an external controller to vary the tube loading factors during the exposure run, in-between
exposures. The external controller must communicate with the generator through the use of a serial protocol
(CANBUS or RS-232) proprietary to EMD Technologies Incorporated. Exposure parameters vary live during the
run.
Fi
Trig Enabl e
~
-
-···· · 0.95 mAs
70 kV
500
>
400
I
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,-.
<
.....
,.:.: 300
a, u::
.c j I I I 3
....
:I 200
1-
.... -
- -- ~
100 --
--
- - "'" "'" _ kV
0 0 __ I Tube
0,000 0,200 0,400 0,600 0 .800 1.000 1, 200 1,400 1,600
Time (s) - lfil
The following four (4) options (P/N 11028.xxx) provide additional supplies for room interfacing. Note that with
the first three (3) auxiliary power supplies, it is mandatory that the generator be supplied with 400Y/230VAC
mains. The fourth option is available with 400-480 VAC mains.
The Cable Discharge Unit option (with C.D. Increased Duty Cycle) (Figure 11) eliminates the slow cable
discharging time characteristic of high kV- low mA exposures. The device acts as an electronic crowbar mechanism
that allows 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.
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~ t
_,,-:,_
!
Rise time
less th a n_0.6 ms
(a) - With Cab le Di sch arge Uni t - Wi t h out Cab le D isch a rg e Unit
(b)
The DAP Interface option allows interfacing a VACU DAP measurement device a HIGH LEVEL
C
on the generator to display, on the Epsilon Operator Console, the radiation level
a patient is exposed to in radiological exams.
a t 15 P/5
ANODE
1
C
Display of instantaneous DAP on the console’s graphic screen a H.U. = 11%
11.57
mGy* m2
C
a NEXT
C
This board provides eight programmable relays that can be used to control x-ray room lines as a function of the
generator status (Figure 12).
J2
(a) KlA
Kl
Prgr. Out Kl
–– : Common contact;
–– : Normally open contact ;
–– : Normally close contact
- K1-K4 : GROUP I
==========
K5-K8 : GROUP II
ISOLATION BARRIER
(a) Relay board mounted on its Assembly Plate; SPDT Relays ratings:
(b) 12-Position Terminal Block (28-12 AWG). 10 A @ up to 250 VAC;
10 A @ up to 30 VDC.
(c) K1-K8 Relays Programmable output mode of operation.
The Increased Duty Cycle option (Figure 13) 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
Thermostatic
Fans (2) inside
Generator case
© © ©
o I
A custom power distribution unit (PDU) can be provided as per customer requirements and ancillaries.
Contact EMD Technologies Incorporated for specific requirements.
Consists of a plug-in board and the necessary software to perform AEC exposures on up to 3 different solid
state AEC chambers. This board includes also an additional interface for a standard ion chamber.
2 TECHNICAL SPECIFICATIONS
Overvoltage Category II – The generator is intended to be used in “Overvoltage Category II” locations where
the mains transient voltage would not be higher than 2500 Vpeak.
Three-phase Mains – The generator requires a three-phase electrical line with a protective earth ground (PE) and
an optional neutral (N) wire (4 or 5 wires). Standard line regulation from no load to full load will provide full power
output, at maximum kV.
3 Phase DELTA,
balanced earth or floating
3 Phase WYE
X-ray
..___ _ _ _ L2 \ ~-;t:~lation ) installation
---------- L3
i - - - - - - - - - - (N)
-I ~ - - - - - L2
- - - - - - - - - - - -4, ----------- L3
-----------½
-Notes
(1) Automatic mains selection (no transformer tap configuration required). Automatic kW derating when mains
voltage drops below -12% The system integrator or installer shall be responsible for providing an adequate
means of disconnect from mains supply. Thermal breaker recommended.
(2) The system integrator or installer shall be responsible to provide an adequate over-current release. The values
indicated in this table are suggested figures: the selected overcurrent release should have current rating versus
time curve characteristics higher than the values specified.
The means of disconnect must be located within the reach of the operator/service.
(3) Nominal line current values evaluated with a Mains apparent resistance of supply mains of 0.16 Ω.
(4) Add 4A to current ratings and 3kVA to kVA rating when the Auxiliary Power Supply option is installed.
(5) Values based on [Standby/Ready state/ Fluoro] mode.
Table 7- Combination of x-ray tube Voltage (kV) & Current (mA) for maximum power (kW)(1)
Tube Current (mA) 200 250 320 400 500 630 800 1000
EPS 70
kW 30 37 48 60 70
Nominal kV 150 150 150 150 130 103 81
EPS 65
kW 30 37 48 60 65
Nominal kV 150 150 150 137 110 87
(4 Inverters)
EPS 55
kW 30 37 48 55
Nominal kV 150 150 150 125 100 79
EPS 50
kW 30 37 48 50
(1) Nominal electric power outputs (in kW) are given for 100-ms tube loading time.
1-kV steps; X-ray tube voltages according to available electrical power (Table 7).
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
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.
Notes:
1. Accuracy specifications were measured as per IEC 60601-2-54 requirements.
3. Irradiation time measured as the time interval between the instant high voltage rises above 75%
of its set value and the instant it falls below the same value
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.
-3 -2 -1 Normal +1 +2 +3
• 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.
Photodiode interface
This option requires the Photodiode Ion Chamber board P/N 11030.001. One BNC type connector is used for
ABS/AEC feedback input from the photodiode device.
The EPS RF High-Voltage Generator requires one of two available boards to interface Fluoro (Figure 16). The
Fluoro board is selected as a function of the room ABS device and is installed in the Expansion Basket.
0
0
.,,,
0
0
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.
Fluoro Low-Level “ON” 1 beep/2 seconds; can be disabled by Field Engineer @ installation.
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.
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.
Four (4) service programmable kV/mA tracking curves are provided to improve contrast during Fluoro image
stabilization.
ABS3
,ce
E 20
,1,,1
Ill
00
...
(II
0
ABS2
~ BO
0
60 ABS1
40
20
ABS4
BO 100 120
kV
Number of Tubes One X-ray tube standard; 2-tube configuration available as an option.
Models Most popular X-ray tube models are supported through a built-in X-ray tube chart. Other
X-ray tube models may be added by the installer.
Tube Filaments
Focal spot number : 2
Current range : Up to 8.1 RMS amperes
Filament power : Maximum 100 watts
Tube Derating
The tube factors (*) can be derated to extend its usable lifetime, to troubleshoot specific conditions or other reasons.
kW1 Low
Small
kW2 > kW1 High
Up to 14 programmable digital inputs are available on the generator for interfacing purposes (10 on Controller
board, 2 on Fluoro board 9822.01 and 4 on Fluoro board 11030.001). All inputs are active low and use isolated
diodes at their front ends. A pull-up voltage (+5VDC or +12VDC) is conveyed to the input terminals for reference.
Up to 12 programmable digital outputs are available on the generator for interfacing purposes (8 on Controller
board, 4 on Fluoro board 9822.01 and 2 on Fluoro board 11030.001). All outputs are open collector switches to
the system DC return.
Output Reference: Maximum current in on-state: 100 mA (max. current from J14-11)
Maximum voltage in off-state: 30 V
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 75 kV type (between 10 to 30 meters long).
Types ll or lll as per NEMA Standard XR 7-1979 (R 1984, 1990), with locking screw available at both
extremities of the cable.
5) Mains line and protective ground cables: Unshielded type, length and wire gauge must be in accordance with
applicable electrical code and local regulations.
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 be done in a way that
respects the local environmental regulations in force.
1- 472
(18 5/8)
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27 (1) - -
(15 5/16)
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1111111111111111 II III II III
11 U111111 U11111 H1111111
111111 11 111111 11 1111111111 441
(17.375)
1111
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(16.125)
MOUNTING
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- -- - - - - ( 131/8" )- - - - -- 55 mm
( 21/8" )
---+-----
-------------,' r-,
-
0
Figure 20 –
Operator Console Dimensions. 276 mm
(10 7/8")
3 COMPLIANCE INFORMATION
Epsilon High-Voltage Generator complies with the following standards and regulations:
Canada Safety Certified to CAN/CSA-C22.2 NO. 60601-1:2014, IEC 60601-2-54: 2009+ A1: 2015
& IEC 60601-1-3: 2008+A1: 2013
USA Safety Conforms to AAMI ES60601-1: 2005+A1: 2012, IEC 60601-2-54: 2009+ A1: 2015 &
IEC 60601-1-3: 2008+A1: 2013
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+A12: 2014, EN 60601-2-54: 2009+A1: 2015 & EN 60601-1-3: 2008 +A1: 2016
International IEC 60601-1: 2005+A1: 2012, IEC 60601-2-54: 2009+A1: 2015 & IEC 60601-1-3: 2008 +A1:
2013
Important Notice
• Conformity is based on the equipment configured and interconnected as described in the present Technical
Manual. Changes or modifications to this equipment not expressly approved by EMD Technologies Incorporated
could void its conformity to applicable standards.
• Conformity to EN/IEC 60601-2-54 and EN/IEC 60601-1-3 shall be validated when the generator is integrated
within a complete Medical Electrical System.
End of document