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

Operation
Attention. The PDC – Patient Dose Calibrator should only be used by personnel who are
authorized to use sources of diagnostic medical X-radiation and are acquainted with these
instructions.
Note These instruction apply only to the PDC when used without a computer running the
application software being connected.
Switching on the device
A short press of the button marked ON/OFF will switch the PDC on.
The display shows the following sequential information:
Radcal
- The device name:
Patient Dose Calibrator
- Software version (x.xx)
PDC x.xx
- A test of all indicator LED’s and a digit test of the display is then performed.
Thereafter the power-on test sequence starts:
TEST
The required time for the power-on test is displayed.
Three test values (T1 –T3) are then displayed and internally evaluated. At the end of the
power-on test a battery check is carried out and the
The percentage of residual charge of the battery is displayed.
After the power-on test the zero current is checked:
ZC-CHECK
The required time for the zero current check is displayed.
The zero current check takes place over the period that was indicated.
RESET
O.K.
The PDC’s internal microprocessor switches the measuring range to “low rate” and the
measuring mode to “dose area product”. This is indicated by turning on the LED “low rate”
and the LED for the dimension unit “μGyAm²”
11

Readiness for use is shown in the display as
0.00
RESET function
The RESET function resets the display of measured dose area product and air kerma
regardless of the selected display mode.
A short press of the reset (test) button starts the RESET function.
The PDC incorporates an Auto-Reset at a default time of 15 seconds following a
measurement or other operation. The auto reset time can be adjusted or disabled via the
PCD software (see separate manual).
Note. After expiration of the Auto-Reset the PDC resets the display of dose area product
and air kerma automatically to zero. If a subsequent exposure is measured prior to
Auto-Reset it will be added to the dose area product and air kerma already displayed
(commonly know as accumulate mode).
TEST function
The TEST function checks that all the components of the measuring system are
functioning correctly.
In the course of this, three test values are determined and compared to factory-set
nominal reference values. If the current test values are within an accepted tolerance
range, the TEST function has been performed successfully. In case of failure, an error
message is displayed.
At the end of the power-on test a battery check is carried out and the percentage state of
charge is displayed.
When the PDC is switched on, the TEST function is started automatically (power-on test).
The test function can be used at any time by pressing the reset (test) button for 2 seconds
(until “RESET” on display changes to “TEST”). If the button is pressed for a longer period
the TEST function will be cancelled.
Display mode
The Patient Dose Calibrator provides two display modes “dose area product” and “air
kerma”. The selected display mode is indicated by the LED together with the selected
dimension unit.
When X-rays are detected the display indicates “dose area product rate” or the “air kerma
rate” and the measured quantity is indicated by the corresponding LED. Following
termination of the exposure the accumulated “dose area product” and “air kerma” is
displayed.
To change the display mode press the mode selection button and confirm the function has
been completed by inspection of the indicator LED’s.
It is possible to toggle between dose and dose area product following a measurement.
Note The field sized must be greater than 10 cm diameter to display a valid dose reading.
By dividing the displayed DAP by the dose, it is possible to derive the approximate
radiation field area.
12

Measuring range
The PDC can measure Dose, Dose Rate, DAP and DAP Rate. The DAP and DAP Rate
have either low or high dose rate range.
When in the dose area product display mode the PDC has two ranges “low rate” and “high
rate”. The selected rate is indicated by the corresponding LED. The rated range of use for
each is given on page 15 of the Technical specifications.
Note The system automatically defaults to the “Low Rate” mode and when the rate
is to high, an error message “OVERRATE” will be displayed. The mode should then
be changed to “High Rate”.
To change the measuring range press the range button and confirm the function has been
completed by inspection of the indicator LED’s.
Note. The measured values are displayed as floating point numbers.
Low battery indicator
The LED “low battery” is turned on when the state of charge of the internal lithium ion
battery is less then 20%. In this condition the device will be operable for at least one hour.
When the battery is completely exhausted the device switches off automatically.
Switching off the device
By pressing the on/off button for minimum two seconds, the device is switched off.
Note. The PDC incorporates an auto power off feature. The system is switched off
automatically after 15 minutes of inactivity (default time, the time can be changed via the
PC software).
Dose and dose rate measurements
Depress the ‘Mode’ button until the ‘mGy’ indicator is illuminated. Make sure that the x-ray
field size is larger than the red 10 cm diameter circle area indication on the PDC cover.
Set the exposure to be greater than 1 second. Ensure that the display reads zero. Press
the ‘Reset’ button to clear any erroneous readings caused by movement. The dose rate
will be immediately displayed during the exposure and the dose is displayed following the
exposure. The software can be used to capture the exposure dose rate. Note that the
high and low range mode does not affect the dose and dose rate functions. The PDC
readings will self-clear in 22 seconds or can be manually cleared by pressing the ‘Reset’
button.
DAP and DAP Rate measurements
Depress the ‘Mode’ button until the ‘uGy*m2‘ indicator is illuminated. Make sure that the
x-ray field within the 30x30 cm area indication on the PDC cover. The field can be any
shape as long as it is within the 30x30 cm area indication. Select ‘low rate’ for expected
exposures from 1 uGy*m2/min to 10 mGy*m2/min. Select ‘High range’ for exposures
exceeding 2 mGy*m2/min. Set the exposure to be greater than 1 second. Ensure that
the display reads zero. Press the ‘Reset’ button to clear any erroneous readings caused
by movement. The DAP dose rate will be displayed immediately during the exposure and
the DAP is displayed following the exposure. The software can be used to capture the
exposure DAP rate. The PDC readings will self-clear in 22 seconds or can be manually
cleared by pressing the ‘Reset’ button.
13

Trouble Shooting
Fault correction table
Error message Meaning Suggested action
ZC-ERROR * Zero check error * X-radiation was active during RESET
function.
-> Radiation off, repeat RESET.
* In case of repeated occurrence: contact
service.
TE-ERROR * TEST error * One of the Test values is out of the
tolerance range.
-> Switch measuring system OFF and ON
again.
* In case of repeated occurrence: note
the displayed test-values and contact
your Radcal representative.
OVERRATE * maximum dose-rate
is exceeded
* ->Change the measuring range to “high
rate”, RESET; repeat measurement
LOW RATE * Below minimum
dose-rate
* ->Change the measuring range to “low
rate”, RESET; repeat measurement
OVERFLOW * Display range
(accumulated value)
is exceeded
* DAP > 99 999 999 μGy*m² or
AK > 99 999 999 mGy
-> RESET; repeat measurement.
TW-ERROR
EE-ERROR
HV-ERROR * Electronic error
* Electronic error was detected.
-> Switch measuring system OFF and ON
again.
* In case of repeated occurrence: note
the displayed test-values and contact
your Radcal representative.
14

Technical specifications
Notes:
All technical data is valid for the ambient conditions as defined in IEC 60580.
Only values given with tolerance ranges or limits are guaranteed.
All other values are for information only.
Subject to change without prior notice.
Ionization chamber
Response, 700 pC / μGyAm²
Leakage current, < 0.1 pA
Response versus radiation quality, ± 3 %
(50 kV …150 kVp, norm. to 100 kVp; according to IEC 60580)
Equivalent filtration, (70 kV) 0.6 mm Al
Active area,
Dose area product maximum, (300 x 300) mm²
Air kerma minimum 100 X 100 mm2(at center of chamber assembly)
Chamber polarization potential, 300 V
Distance between electrodes, 10.5 mm
Stabilization time, 3 min
Measuring system
Digital resolution,
Dose area product, 0.01 μGyAm²
Dose area product rate, 1 μGyAm²/min
Air kerma, 0.001 mGy
Air kerma rate, 0.1 mGy/min
Display range,
Dose area product, 0.01 - 99 999 999 μGyAm²
Air kerma, 0.001 - 99 999 999 mGy
System performance
Rated range of use.
Tube voltage, 40 - 150 kV
Dose area product rate, (low rate range)
1 – 1 X 104μGyAm²/min
Dose area product rate (high rate range)
2 X 103– 9 X 105μGyAm²/min
Air kerma rate, 0.2 - 9 X 103mGy/min.
Operating atmospheric pressure range, 80.0 - 106.0 kPa
Operating temperature range, +10 - +40) °C
Air humidity 10 - 80 %
Relative humidity, max. 20 g/m³
15

Accuracy.
DAP ± 10%
Air kerma ± 10%
DAP ± 7.5%
Air kerma ± 7.5%
Inclusive of all uncertainties i.e. temperature, pressure rate,
area and beam quality
Under reference conditions
10 mGy/min, 15 x 15 cm field, 80 kVp, 2.5 mm Al filtration.
Power supply
Internal rechargeable battery pack Li-ION, 2 cells Panasonic CGR18650CF (UL 1642)
Nominal voltage, 7.2 V
Nominal capacity, 2.25 Ah
Maximum charge, voltage 8.2 V
Maximum charge, current 2.5 A
Number of charge/discharge cycles, > 500
Operation time (initial state of charge= 100 %), > 8 h
General
Serial interface USB (virtual COM)
Protection class (acc. IEC 60529) IP 41
Weight 2.32 kg
Dimension (length x width x height) 350 mm x 410 mm x 35 mm
16

Support Elevation Stand
Foam Elevation Support Stand fits inside the interior of the Carry Case lid
17

Warranty for the Model PDC - Patient Dose Calibrator
Radcal Corporation warrants that, in the event that any defects in material or workmanship
should develop within one year of the date of shipment, the company assumes full
responsibility for servicing equipment of its manufacture without charge upon return of the
equipment to Radcal, with shipping costs prepaid by the customer. Costs to return-ship to
customer by ground transportation will be paid by Radcal if the repairs are warranty-
applicable. This warranty excludes batteries.
Radcal shall not be held liable for damages or delays caused by defects beyond making
repairs or furnishing replacement parts, nor shall Radcal be liable for any defective
material replaced without Radcal’s consent during the period of this warranty. Radcal
reserves the right to perform warranty services at its own factory.
Non-Warranty Repairs
The calibration of this instrument was correct within specified limits when the instrument
left our factory. Radcal cannot be responsible for injury or damage resulting from improper
use or calibration errors which develop subsequent to our shipment of the instrument.
If Radcal determines that a fault has been caused by misuse, abnormal operating
conditions, or repairs by unauthorized personnel during the warranty period, repairs and
shipping costs will be billed at normal rates.
If the equipment is found to be in proper working condition, Radcal will return-ship the
equipment at customer expense.
18

Declaration of Conformity
According to Engineering Report # ER1190829-PDC
Manufacturer’s Name: Radcal Corporation
Manufacturer’s Address: 426 West Duarte Road
Monrovia, CA 91016
U.S.A.
Declares that the Product
Product Name: Patient Dose Calibrator
Model Number(s): PDC-01
Product Accessories: All
Conforms to the following Product Specification:
EMC: *
EN 61326-1 (2013) Group 1 Class B
EN 61000-4-2
EN 61000-4-3
EN 61000-4-4
EN 61000-4-6
EN 61000-4-5
EN 61000-4-11
EN 61000-3-2
EN 61000-3-3
PERFORMANCE:
IEC 61674
The product herewith complies with the RFI-emissions requirements and
immunity requirements and carries the CE marking accordingly.
E. MacIntosh
Technical Manager
August 29, 2019
* Tested with 3m USB cable
19