Radcal PDC User manual

Model PDC
Patient Dose Calibrator
Instruction Manual

MADE IN GERMANY FOR RADCAL CORPORATION UNDER THE
FOLLOWING PATENT: PAT NO. 7,413,345
Radcal Corporation
426 West Duarte Road
Monrovia, CA 91016-4591 USA
USA [phone]
Fax USA [phone]
email [email protected]
www.radcal.com
Radcal Part # MNL/PDC
4077009 Rev:G
Firmware V1.09
Printed: Aug, 2019

Note.
The system automatically defaults to the “Low Rate” mode and when the rate is too high,
an error message “OVERRATE” will be displayed. The mode should then be changed to
“High Rate”.
Attention.
The PDC cannot be switched on when the battery charger is connected. Always
disconnect the battery charger before using the system.
Important.
Throughout this manual the following words are given a specific meaning and the
reader should be aware of their significance.
Attention; Used where there is a risk of damaging the PDC by
incorrect handling or operation error.
Note; Used where information is provided to aid better understanding of
the PDC or its use.
4

CONTENTS
General user information ................................................. 6
Application ..................................................... 6
Classification ................................................... 6
Electromagnetic compatibility (EMC) ................................. 6
Protection against electric shock .................................... 6
Handling,transport,shipping ....................................... 6
Cleaning ....................................................... 6
Storage, conditions of application ................................... 7
Disposal ....................................................... 7
Systemdescription ...................................................... 8
Introduction .................................................... 8
Construction .................................................... 8
TheIonchamber ................................................ 8
Theradiationtarget .............................................. 8
TheElectronicsystem ............................................ 8
Computer connection ............................................. 9
Preparations for operation ............................................... 10
Preparation .................................................... 10
Chargingthebattery............................................. 10
Power-ontest .................................................. 10
Stabilization time ............................................... 10
Operation ............................................................ 11
Switchingonthedevice .......................................... 11
RESET function ................................................ 12
TESTfunction ................................................. 12
Displaymode .................................................. 12
Measuring range ............................................... 13
Lowbatteryindicator ............................................ 13
Switchingoffthedevice .......................................... 13
Dose and dose rate measurements ................................. 13
DAP and DAP Rate measurements ................................ 13
Trouble Shooting ...................................................... 14
Faultcorrectiontable ............................................ 14
Technicalspecifications ................................................. 15
Ionizationchamber.............................................. 15
Measuringsystem .............................................. 15
Systemperformance ............................................ 15
Power supply .................................................. 16
General ...................................................... 16
Warranty............................................................. 18
5

General user information
Attention. This section contains essential information that is required for the safe use of
the Patient dose Calibrator (PDC)
Application
The Patient Dose Calibrator PDC has been designed for checking the calibration of dose
area product meters and air kerma meters used in patient dosimetry. It can also be used
to establish reference dose and dose area product levels for specific examinations and to
check the consistency and behaviour of automatic exposure control systems.
Classification
The Patient Dose Calibrator PDC is not a medical device; it is a laboratory measuring
instrument and should not be used with patients.
The protection afforded by the housing of the PDC corresponds to IP41 (IEC 60529).
The device is not suitable for application in proximity of combustible substances.
Electromagnetic compatibility (EMC)
This laboratory measuring instrument complies with the international standard IEC
60601-1-2 and meets the EMC protection requirements for medical devices.
Portable and mobile HF communication systems may affect electrical measuring devices.
The Patient Dose Calibrator was designed to power off if exposed to electro-static
discharge (ESD).
Protection against electric shock
The Patient Dose Calibrator PDC is powered by an internal lithium ion (Li-ION) battery
pack. For charging the battery a special charger unit for medical devices with safety
extra-low voltage (SELV) features is used.
When charging the internal lithium ion battery pack only use the charger supplied with the
instrument or a replacement obtained from the manufacturer.
Handling, transport, shipping
The ionization chamber and electronic system are highly sensitive components and must
be handled with care.
For transport and return shipment the original or an equivalent packaging must be used.
During transport the following ambient conditions must be maintained.
Temperature 0°C - 50°C
Relative air humidity 10% - 80% (max. 20 g/m3; non-condensing)
Cleaning
When cleaning the ionization chamber no abrasive cleaners and no organic solvents or
cleaning agents containing solvents (e.g. petroleum ether, alcohol) must be used.
The enclosure of the PDC can be cleaned by wiping with a damp cloth containing a mild
washing-up liquid solution.
6

Storage, conditions of application
Nominal range of application with regard to temperature and relative air humidity can be
found in the Technical specification on page 15.
A relative air humidity exceeding 80% can cause precipitation of condensate on the
ionization chamber and electrical connections. This will lead to increased leakage current.
Where the PDC might have been exposed to excessive humidity, the risk of such
insulation failures can be reduced by drying the ionization chamber at an elevated
temperature (max. 50°C).
A relative air humidity exceeding 80% can cause precipitation of condensate on the
ionization chamber and electrical connections. This will lead to increased leakage current.
In order to eliminate such insulation failures, the ionization chamber may be dried at an
increased temperature (max. 50°C).
Disposal
The device contains a lithium ion battery pack and electronic components. It must be
disposed of in accordance with the applicable national regulations or returned to the
manufacturer.
7

System description
Introduction
The PDC is designed to function as a stand-alone battery powered instrument. Its
application can be extended by connection to a PC computer running the optional
software package (see separate software user manual). A support stand is
provided to elevate the PDC above structures that might add scattered radiation
to a primary beam measurement.
The PDC has been designed for use with a patient equivalent phantom when
measuring entrance or image receptor doses. This is not included in the system
package.
Construction
The PDC consists of an ion chamber assembly, electronic printed circuit board
incorporating displays, a switch panel and battery.
The components are housed within a protective housing that incorporates a beam
alignment target.
Note. There are no user accessible components within the housing.
The Ion chamber
The ion chamber is suspended within the protective housing to minimize
disturbance during positioning the PDC in the radiation beam. The chamber
consists of central and outer active areas. Dose measurement uses the central
area only whilst both areas are used for DAP measurement.
The radiation target
A target assembly is provided to assist with alignment to the radiation beam.
Attention. When making dose measurements the radiation field size must exceed
the red 10cm diameter area.
Where a light field is not available a matrix of radio-opaque markers are provided
for alignment with a fluoroscopic image. The markers are placed at points of
major intercept on the target and are illustrated by red dots.
The Electronic system
The PDC uses a micro controller to manage and process instructions and
measurement data. A common high voltage generator is used to energize both
sections of the ion chamber. The system incorporates three independent
electrometers that are permanently coupled to collector plates of the ion chamber.
Their functions are:
1. Central area
2. Outer area, low sensitivity
3. Outer area, high sensitivity
The electrometer outputs are continuously sampled by the processor.
8

The operator can use the mode switch to select dose or DAP display, both are
available during or following a X-ray exposure.
When the system senses radiation the display automatically indicates dose or
dose area product rate. At the end of an exposure the display indicates the
accumulated dose or dose rate.
The user can manually set the display to zero at any time with the rest switch. For
convenience there is an automatic zero function (default setting, auto zero 15
seconds after the end of a radiation exposure).
The system performs an automatic test routine when switched on. This involves a
display test, electrometer test, battery check and electrometer auto zero.
The battery is charged with a charger that is supplied with the system and when
charged provides 8 hours of operation.
If the system is not used for a prolonged period (default value 15 minutes) it is
automatically switched off.
Computer connection
When connected to a PC running the optional software package control is via the
computer and with the exception of the power on/off button all PDC located
controls are disabled. Please see the software manual for more details.
9

Preparations for operation
Preparation
The PDC should be carefully removed form its packing case and inspected. If any damage
to the components is found, the supplier or manufacturer should be contacted. Damaged
components must not be used.
Charging the battery
The Patient Dose Calibrator is delivered with a basic state of charge of the internal battery
of approximately 25 %. The actual state of charge is displayed during the test function.
It is recommended that the battery is fully charged before first use.
Attention. When charging the Patient Dose Calibrator, use only the original charger or a
manufacturer supplied replacement!
Note. When the battery is fully charged the PDC will function for a minimum of 8 hours. To
charge a completely exhausted battery takes about two hours.
Note. If the PDC battery is completely flat, when the charger is plugged in its yellow
charging indicator lamp fails to glow until the load on the power supply is reduced after
about 30 minutes of charging.
Power-on test
Note. Prior to use, all components of the measuring system should have been adapted to
room temperature.
The measuring system includes an automatic power-on test during which the function of
the ionization chamber and all electronic systems are checked.
Stabilization time
The ionization chamber is a highly sensitive detector which must stabilize following
application of the ionization potential in order to meet the specified performance, see page
15 of this manual. The same applies to the analogue portion of the electronic system.
The period of time required for this process is known as the stabilization time.
The measuring system is however operational during this stabilization time.
The required stabilization time for the ion chamber can be found on page 15 of this
manual.
10