Varex Imaging Claymount AmpMC 3-field Series User manual

TM20514-10, Revision: 3.0
www.vareximaging.com
0120
AmpMC 3-field Series
Intended Part numbers as listed in Table 1
Technical Manual

Technical Manual: TM20514-10
AmpMC 3-field Series
Revision: 3.0
Date of release: 2019-01-09 2/24 www.vareximaging.com
Table of Contents
Table of Figures ........................................................................................................................................3
1. Introduction ...................................................................................................................................4
Contact information..............................................................................................................4
Declaration of Conformance ................................................................................................4
Symbols used in this document ...........................................................................................4
Abbreviations .......................................................................................................................5
General warnings, cautions and notes ................................................................................5
Supplied components ..........................................................................................................5
Accessories..........................................................................................................................6
2. Product description .......................................................................................................................7
Intended use ........................................................................................................................7
Description of the device......................................................................................................7
Principle of operation ...........................................................................................................7
Classifications ......................................................................................................................7
Restrictions on use ..............................................................................................................8
Contraindications .................................................................................................................8
Overview of the device.........................................................................................................8
Specifications .......................................................................................................................9
3. Installation.................................................................................................................................. 10
Installation requirements................................................................................................... 10
General Installation instructions........................................................................................ 10
3.2.1. Check according to the build-in LED’s .............................................................................. 10
3.2.2. Generator Switch off check................................................................................................11
Necessary recurrent testing ...............................................................................................11
4. Mains isolation ........................................................................................................................... 12
5. Service, maintenance and cleaning .......................................................................................... 12
Safety precautions ............................................................................................................ 12
Cleaning ............................................................................................................................ 12
Disinfection........................................................................................................................ 12
Procedure at defects......................................................................................................... 12
6. Device Data ............................................................................................................................... 13
1001, 1006, 1008, – 3-field integrating amplifier............................................................... 13
6.1.1. Generator Interface connections....................................................................................... 14
6.1.2. Sensitivity settings ............................................................................................................ 14
6.1.3. Ramp Polarity settings ...................................................................................................... 15
6.1.4. Inputs reset / exposure settings ........................................................................................ 15
6.1.5. Inputs for measuring field selection .................................................................................. 15
6.1.6. Plug pinout reset / ramp selection..................................................................................... 16
6.1.7. Assignment of measuring fields to the signal inputs......................................................... 16
7. Quality Assurance...................................................................................................................... 16
8. Disposal, ESD and EMC compatibility ...................................................................................... 17
Disposal ............................................................................................................................ 17
ESD................................................................................................................................... 17
EMC compatibility ............................................................................................................. 17
8.3.1. Deviations ......................................................................................................................... 17
8.3.2. Allowances ........................................................................................................................ 18
8.3.3. Precautions ....................................................................................................................... 18
8.3.4. Emissions Compliance...................................................................................................... 18
8.3.5. Immunity Compliance ....................................................................................................... 18

Technical Manual: TM20514-10
AmpMC 3-field Series
Revision: 3.0
Date of release: 2019-01-09 3/24 www.vareximaging.com
9. Product label and symbols on the device.................................................................................. 21
Product label ..................................................................................................................... 21
Symbols on the device ...................................................................................................... 21
Table of Figures
Figure 1 Means of protection................................................................................................................. 12
Figure 2 Image of an AmpMC ............................................................................................................... 13
Figure 3 Lay-out Mechanical ................................................................................................................. 13
Figure 4 DIL switch location .................................................................................................................. 13
Figure 5 The connection against GND in active H mode ...................................................................... 15
Figure 6 The connection against GND in active L mode....................................................................... 15
All rights reserved
Although this guide is prepared with utmost care, Varex Imaging Nederland B.V. assumes no
responsibility for errors or omissions.
Varex Imaging Nederland B.V. cannot be held accountable for damages of any nature arising from the
use, and / or use of any options other than original Varex Imaging Nederland B.V. products.

Technical Manual: TM20514-10
AmpMC 3-field Series
Revision: 3.0
Date of release: 2019-01-09 4/24 www.vareximaging.com
1.Introduction
Contact information
This manual provides all the technical information necessary for the correct installation, application
and maintenance of the AmpMC.
If you need additional information, need support or want to report a problem with the device, please
contact your distributor or Varex Imaging Nederland B.V.:
Manufacturer
Distributor
Name
Varex Imaging Nederland B.V.
Address
Anholtseweg 44
7091 HB Dinxperlo
The Netherlands
Telephone
[phone]
Fax
[phone]
E-mail
[e-mail]
Website
www.vareximaging.com
For support and service purposes, please note the following information:
Model name:
Part number:
Serial number:
Declaration of Conformance
Varex Imaging Nederland B.V. hereby declares that this product is in conformity with the essential
requirements and provisions as set forth in European Union Council Directive 93/42/EEC concerning
medical devices (revision 2007-09-27). See the included Declaration document.
Symbols used in this document
To ensure adequate and clear understanding of the information provided in this manual, the symbols
listed below are used to indicate warnings, cautions, actions and notes that are important for correct
and safe use of the device.
WARNING:
Warnings are directions which, if they are not followed, can cause fatal or serious injuries
to a user, engineer, patient or any other person or can lead to a mistreatment.
CAUTION:
Cautions are directions which, if they are not followed, can cause damage to the device
described in this manual or any other equipment or goods and can cause environmental
pollution.
NOTE:
Notes provide advice and highlight unusual points. A note is not intended as an
instruction.

Technical Manual: TM20514-10
AmpMC 3-field Series
Revision: 3.0
Date of release: 2019-01-09 5/24 www.vareximaging.com
Abbreviations
Term
Definition
AEC
Automatic Exposure Control
EMC
Electromagnetic compatibility
ESD
Electro Static Discharge
ME
Medical Equipment
This document contains terminology and definitions based on (international) standards. The
terminology and definitions are formatted in capital letters (e.g. INTENDED USE). Terminology and
definitions from the following standards are used:
Reference
Title
IEC 60601-1
Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-2
Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance – Collateral Standard: Electromagnetic disturbances
– Requirements and tests
IEC 60601-1-3
Medical electrical equipment – Part 1-3: General requirements for basic safety
and essential performance – Collateral Standard: Radiation protection in
diagnostic X-ray equipment
IEC 60601-2-54
Medical electrical equipment – Part 2-54: Particular requirements for the basic
safety and essential performance of X-ray equipment for radiography and
radioscopy
General warnings, cautions and notes
WARNING:
To avoid the risk of electric shock, this equipment must only be connected to a system
isolated from supply mains according to IEC-60601-1
WARNING:
Do not modify this equipment without authorization of the manufacturer.
WARNING:
The device contains sensitive electronics. Ensure that ESD protective measures are in
place when the device is installed or serviced to prevent damage to the device.
Supplied components
The device that you have purchased is packed in a transport box appropriately designed to ensure the
integrity of the device. Please ensure that the contents of the package you received is intact and that
there are no traces of moisture or visual damages. Otherwise, you should immediately contact your
distributor or Varex Imaging Nederland B.V.. The package contains the following components:
Amount
Description
Reference
1
AmpMC
For Model and Part number see the product label on
the AmpMC.
1
Technical Manual
TM20514-10
1
ECDoC
Declaration of conformance (CE)

Technical Manual: TM20514-10
AmpMC 3-field Series
Revision: 3.0
Date of release: 2019-01-09 6/24 www.vareximaging.com
Accessories
The following accessories can be ordered separately.
Description
Purpose
Extension cables, for use between SolidStateMC and AmpMC
EXTENSION CABLE, SSMC, 2.5M
To connect all 3-field SolidStateMC models to AmpMC
model 1001 + 1006 + 1008.
EXTENSION CABLE, SSMC, 5M
EXTENSION CABLE, SSMC, 10M
EXTENSION CABLE, SSMC, 45FT
EXTENSION CABLE, SSMC, 15M
EXTENSION CABLE, SSMC, 18M
EXTENSION CABLE, SSMC, 20M
EXTENSION CABLE, SSMC, 25M
Extension cables, for use between the AmpMC and HV generator
EXTENSION CABLE PREAMP, 10M
SubD 9-pin male - SubD 9-pin Female
EXTENSION CABLE PREAMP, 15M
SubD 9-pin male - SubD 9-pin Female
EXTENSION CABLE PREAMP, 20M
SubD 9-pin male - SubD 9-pin Female
EXTENSION CABLE, PREAMP HMC
SubD 9-pin female - AMP 10-pin female
EXTENSION CABLE, PREAMP, 5M
SubD 9-pin male - SubD 9-pin Female
Various
Female connector 6 pin
Connector without cable, solder version. To connect to
SolidStateMC
Male connector 6 pin
Connector without cable, solder version. To connect to
AmpMC

Technical Manual: TM20514-10
AmpMC 3-field Series
Revision: 3.0
Date of release: 2019-01-09 7/24 www.vareximaging.com
2.Product description
Intended use
The device is intended to be used in medical diagnostic applications with restrictions to human
diagnostics. The device is intended to be used as accessory of an X-ray system in a professional
healthcare facility environment. The device is intended to amplify and integrate the output signal of a
SolidStateMC to the AEC-module of an X-ray generator. The limitations of use are specified in §2.8.
The device is not intended to be used in fluoroscopy applications; near active HF Surgical Equipment
or in the RF shielded room of a system for magnetic resonance imaging, where the intensity of
Electromagnetic Disturbances is high.
Use, other than above, is identified as abnormal use.
The device is intended as an internal component of an X-ray system. The intended user is defined as
the SERVICE PERSONNEL of an X-ray system.
Description of the device§§
The purpose of the Automatic Exposure Control (AEC) of an X-ray system is to obtain the correct
image contrast by measuring the radiation quantity striking the film or detector.
To result in a high-quality image, the AEC’s exposure end switch will stop generating X-rays
automatically when the demanded radiation dose on the detector is reached.
Principle of operation
The AmpMC main functions are:
•The conversion of electrical current from a SolidStateMC to a voltage ramp. The voltage ramp
signal is proportional to the received dose of the SolidStateMC.
•To receive field-select signals (from operator via console and generator) and use the correct
field of the SolidStateMC as the incoming signal.
A SolidStateMC serves as a measuring device for X-ray radiation with semiconductor components
(photodiodes) as actual sensors. The ionizing effect of X-ray produces a small electrical current in the
photodiodes and this current is lead to an AmpMC.
The AmpMC converts the small current to a voltage signal that is proportional to the X-ray dose rate,
this signal is integrated and presented as a ramp signal to the AEC controller board inside the
generator and therefore represents a value for the image density.
•There is no signal available for external use about the status of the device.
Classifications
Subject
Classification
Reference
CE
IIB
93/42/EEC
Electrical safety
None
IEC 60601-1
Electromagnetic Compatibility
intended environment
Professional
healthcare facility
environment
IEC 60601-1-2
Mode of operation
Continuous
IEC 60601-1
Ingress protection
IP2X
IEC 60529
Protection
No
IEC 60601-1 table 6
Not intended for use in Oxygen Rich environment.
Not suitable for Sterilization.

Technical Manual: TM20514-10
AmpMC 3-field Series
Revision: 3.0
Date of release: 2019-01-09 8/24 www.vareximaging.com
Restrictions on use
The AmpMC can only be used in combination with a SolidStateMC and in a Radiography X-ray system
that complies with the IEC60601-1 standard, applicable at date of manufacture.
The supply lines must be limited / fused to 15W max. or the AmpMC must be mounted inside a fire
enclosure.
The AmpMC is intended to be installed inside a cabinet of the X-ray system.
Depending on the final assembly, additional measures may need to be taken to comply with EMC
regulations.
Contraindications
The relevant contraindications for the X-ray system continue to apply (see the documentation for the
X-ray system). The AmpMC does not add new contraindications on top of these.
Overview of the device
Table 1 AmpMC specifications
Model
Dimensions
(mm)
Support information
Lay-out
Remarks
Outside
# of fields
Connections
SolidStateMC
Generator
W
L
H
Cable
(m)
Connector
Cable
(m)
Connector
1001
42
222
21
3
None
6 pin Female
0.93
Sub-D 9p male
§ 6.1
3-field SolidStateMC preamp
with single voltage ramp output
1006
3-field SolidStateMC preamp
with single voltage ramp output
and modified reset circuitry
1008
0.8
AMP Header 10p female
/ GND terminal
3-field SolidStateMC preamp
with single voltage ramp output
Configuration of connections
Connector type at generator side
Cable length at generator side
Connector type at SolidStateMC side
Cable length at SolidStateMC side
# of fields that can be controlled
Height of AmpMC
Length of AmpMC
Width of AmpMC

Technical Manual: TM20514-10
AmpMC 3-field Series
Revision: 3.0
Date of release: 2019-01-09 9/24 www.vareximaging.com
Specifications
Description
Reference
Exposure time range
≤ 4 ms to 5 s.
Fine-tuning with potentiometer
- 60% to + 150%
Input range
0.1 – 12.000 nA.
Operating voltage
+/- 12 VDC +/-5% to +/- 15 VDC +/-5%
Measured at the AmpMC.
Supply current
0.1 A @ + 12 VDC 0.1 A @ - 12 VDC
0.1 A @ + 15 VDC 0.1 A @ - 15 VDC
Output signal Ramp
Positive or negative ramp
0 to 10 V @ 12 V
0 to 12 V @ 15 V
Max. Load 47 kΩ
Applicable standards
IEC60601-1:2005 edition 3.0 + C1 + C2 + IS1 + IS2 + A11+ A1
IEC60601-1-2:2014
IEC60601-2-54:2009+C1+C2 + A1
Housing Material
Sheet metal
Weight
< 0.5 kg
Operation environment
Ambient temperature: +10°C to +40°C
Relative humidity: 35% to 85% non-condensing
Atm. Pressure: 860hPa to 1060hPa
Storage
Ambient temperature: -20°C to +60°C
Relative humidity: 35% to 85% non-condensing
Atm. Pressure: 860hPa to 1060hPa

Technical Manual: TM20514-10
AmpMC 3-field Series
Revision: 3.0
Date of release: 2019-01-09 10/24 www.vareximaging.com
3.Installation
NOTE:
Allow system to level with room temperature before installation.
Installation requirements
WARNING:
Installation and initial operation may only be carried out by an expert who has been
trained in the field of medical diagnostic X-ray equipment.
WARNING:
Modifications to the product are not allowed.
WARNING:
When the enclosure is opened, ESD protective measures must be taken to prevent
damage to the electronics.
WARNING:
Always use shielded cable, the total length of this cable shall not exceed 30 meters.
WARNING:
Improper grounding can cause incorrect functioning of the AmpMC
WARNING:
Adjust the potentiometers with great caution. Using excessive force or over adjustment
will result in improper functioning of the AmpMC
General Installation instructions
Position the AmpMC always outside of the active image area. The position of the AmpMC is not critical
and can be mounted anywhere on the system. If the cable lengths are inadequate see the accessories
list in §1.7.
Connect the AmpMC to the control electronics in the generator by means of the connector, see
chapter 6. The connection diagram and plug pin lay-out of this cable are found under chapter 6.
Correct functioning of the AmpMC is guaranteed only if the cable as well as the SolidStateMC
shielding is properly connected.
After functional control, the automatic exposure control is set to the correct dose, checked in all kV-
ranges and for all film-foil-combinations (if applicable) and put into operation. This procedure must be
done according to the manual of the x-ray system.
Check according to the build-in LEDs
LED + 12 / 15 VDC: The LED is on, when the positive supply voltage is present.
LED - 12 / 15 VDC: The LED is on when the negative supply voltage is present.
LED – Reset: The LED is on at reset, off at exposure.
LED’s field I, field II and field III: The corresponding LED’s are on when the field is switched active.