DNV VacuDAP 2002 User manual

Operation Manual
Dose Area Product Measuring System
VacuDAP 2002
valid from serial number: 03 00001
valid from software version: 9.5
VacuTec Messtechnik GmbH Tel.: +49 - (0) 351 - 3 17 24-0
Dornblüthstraße 14 Fax: +49 - (0) 351 - 3 10 50 85
D-01277 Dresden Email: [email protected]
Germany www.vacutec-gmbh.de

Operation Manual
VacuDAP 2002
2002BA01e.DOC / 22.07.2004 2of 22
Introduction
Despite the improvements in X-ray technology as a whole and the progress made in reducing the
required radiation dose levels, X-ray diagnostics continues to be a major source of radiation patients
are exposed to. For this reason, the European Council Directives 96/29/EURATOM (basic safety
standard), 97/43/EURATOM (protection of patients) and the amended German X-ray ordinance
require that patients be not unnecessarily exposed to radiation and that the radiation doses applied be
measured and recorded. The VacuDAP 2002 measuring system is a convenient means of doing this.
The VacuDAP 2002 measuring system is used for determining the dose area product (DAP), a
parameter that comes in very useful when measuring the radiation doses patients are exposed to in a
radiological examination.
The VacuDAP 2002 comprises a circular ionization chamber, miniaturised electronics and a display
unit.
By changing settings and parameters on the display unit, the measuring system can be easily
adjusted to individual measuring conditions. In detail, the following adjustments can be made:
• Selection of measuring mode (radiography/fluoroscopy)
• Selection of one out of two calibration factors (e.g. measurement with/without X-ray table)
• Variation of calibration factors (re-calibration)
• Selection of printout language (German, English, French, Spanish, Italian)
The VacuDAP 2002 measuring system is designed for radiological standard methods using X-ray C-
arm units.
Used symbols:
Notes with this warning symbol must be heeded
VACUDAP
Message displayed on the display unit
Print
Reset
Press these keys on the display unit

Operation Manual
VacuDAP 2002
2002BA01e.DOC / 22.07.2004 3of 22
Table of Contents
1General information for the operator...........................................................4
1.1 Application ............................................................................................................................4
1.2 Classification ........................................................................................................................4
1.3 Electromagnetic compatibility (EMC).................................................................................4
1.4 Protection against electric shock.......................................................................................4
1.5 Accessories ..........................................................................................................................4
1.6 Handling, transport, shipment ............................................................................................5
1.7 Cleaning ................................................................................................................................5
1.8 Storage, operating conditions ............................................................................................5
1.9 Disposal.................................................................................................................................5
2Preparation of operation ...............................................................................6
2.1 Preparation............................................................................................................................6
2.2 Supply voltage ......................................................................................................................6
2.3 Installation.............................................................................................................................6
2.4 Function test.........................................................................................................................7
2.5 Installation and testing of accessories ..............................................................................7
2.6 Stabilization time..................................................................................................................8
2.7 Factory calibration ...............................................................................................................8
3Operating instructions ..................................................................................9
3.1 General ..................................................................................................................................9
3.2 Components and measuring principle...............................................................................9
3.2.1 Ionization chamber and detector electronics .......................................................................9
3.2.2 Display units, connections and control elements.............................................................. 10
3.3 Operation............................................................................................................................ 11
3.3.1 Schematic diagram ........................................................................................................... 11
3.3.2 Turning the unit on ............................................................................................................ 12
3.3.3 TEST function ...................................................................................................................12
3.3.4 MEASURE function........................................................................................................... 13
3.3.5 RESET function ................................................................................................................ 13
3.3.6 PRINT function..................................................................................................................14
3.3.7 Remote control..................................................................................................................15
3.3.8 Selection of measuring mode ........................................................................................... 15
3.3.9 Changing of parameters ................................................................................................... 16
4Preventive maintenance and checks/tests................................................19
4.1 General ............................................................................................................................... 19
4.2 Stability test ....................................................................................................................... 19
4.3 Checking the indicated values for drifting ..................................................................... 19
4.4 Overall calibration test...................................................................................................... 19
5Troubleshooting ..........................................................................................21
5.1 Error codes and troubleshooting .................................................................................... 21
5.2 After-sales service and repairs........................................................................................ 21
6Accessories and options ............................................................................22

Operation Manual
VacuDAP 2002
2002BA01e.DOC / 22.07.2004 4of 22
1 General information for the operator
1.1 Application
The VacuDAP 2002 dose area product measuring system is used for measuring the radiation dose
the patient is exposed to during an X-ray examination.
The measuring unit must not be used for the primary determination of
characteristics of X-ray equipment (constancy checks).
1.2 Classification
According to the 93/42/EWG Directive on medicinal products, the VacuDAP 2002 dose area product
measuring system is a medicinal product of class 1 with measuring function.
The measuring system is designed for continuous operation.
Protection against the ingress of water: class IPx0.
The system is not designed for use in the vicinity of inflammable
mixtures.
1.3 Electromagnetic compatibility (EMC)
This medicinal product complies with the European IEC 60601-1-2 standard (limit values to
IEC 55011, group 1, class A) and satisfies the EMC protection requirements as specified in the law on
medicinal products.
1.4 Protection against electric shock
At the power supply end, all poles must be disconnectable from the mains, or the external power
supply unit must be completely disconnectable from the mains.
The power supply shall be in compliance with the European standard on medicinal electrical devices
IEC 60601-1-1 (see 2.2, Supply voltage). The plug-in power pack offered with the VacuDAP 2002
measuring system complies with IEC 60601-1-1 and has the following safety class:
• safety class II system to IEC 601 - 1 HA 3.
The measuring system VacuDAP 2002 works on a safety extra-low voltage.
1.5 Accessories
Any accessory equipment connected to the serial interface shall comply
with the applicable office machine standard IEC 60950 (VDE 0850).
Only original parts or parts complying with the regulations specified by
the manufacturer may be used on the measuring system.
See Chapter 6, Accessories and options, for a list of accessory parts offered.

Operation Manual
VacuDAP 2002
2002BA01e.DOC / 22.07.2004 5of 22
1.6 Handling, transport, shipment
The ionization chamber and the detector electronics are highly fragile components and therefore need
to be handled with utmost care.
The original or an equal packing should be used for any transports and when returning the system.
Because of the risk of damage to the ionization chamber, the electrodes
of the measuring chamber must not be subjected to mechanical
pressure.
1.7 Cleaning
Do not use scouring or solvent-containing cleansing agents (e.g. benzine,
alcohol, stain-remover) or organic solvents for cleaning the measuring
chamber.
Using such agents may result in damage to the conductive layers on the electrodes. Cleaning the
measuring chamber with a cloth soaked in water with a mild washing-up liquid added is possible.
While cleaning, make sure no moisture gets into the ionization chamber.
The chamber must be dry before starting the system again.
Clean the display unit by wiping it with a disinfectant.
1.8 Storage, operating conditions
The dose area product measuring system inclusive of power pack and
accessories may only be used indoors.
Moisture may deposit on the ionization chamber and electric terminals when the relative humidity is
greater than 80%. This would lead to an increased leakage current and the error message
ERR:xxxx appearing upon completion of the system test.
This trouble, which is due to reduced insulation levels, can be eliminated by drying the chamber at an
increased temperature (max. 50°C).
1.9 Disposal
The measuring system contains electronic components and has to be disposed according to the valid
national regulations or it has to be sent back to the manufacturer.

Operation Manual
VacuDAP 2002
2002BA01e.DOC / 22.07.2004 6of 22
2 Preparation of operation
2.1 Preparation
The VacuDAP 2002 measuring system comprises the following components:
• Ionization chamber
• Detector electronics
• Display unit
• Cable (signal line) for connecting the detector electronics to the display unit
• Plug-in power pack
• Optional accessories (see 6, Accessories and options)
Remove the packing material carefully. Should any components found to be damaged, contact the
supplier or manufacturer. Damaged components may not be used.
2.2 Supply voltage
For powering the measuring system VacuDAP 2002, a plug-in power pack is offered which meets the
IEC 60601-1-1 standard. The length of the power pack's connecting cable is approx. 1.8 m.
Alternatively, an extra-low voltage ranging between +15 V ... +24 V can be tapped from the X-ray unit
provided this power supply complies with the European standard for medical electrical devices
IEC 60601-1, is short-circuit-proof, and has a current-carrying capacity of ≥300 mA (in case of a 2-
channel measuring system 956 00 01: ≥500 mA). Further requirements can be found in Chapter 1.4,
Protection against electric shock.
The supply voltage is applied by means of a power pack connector (outer diameter: 5.5 mm; pin
diameter: 2.5 mm) the centre contact (pin) of which carries the positive potential (+15 V ... +24 V). The
reference potential (ground, GND) is that of the metallic housing parts of the display unit and the
housing of the electronics.
The measuring system is provided with an internal polarity reversal protection.
2.3 Installation
The measuring system shall be installed by a duly qualified person.
The dimensions of the ionization chamber are dependent on the specifications of the X-ray unit and
the used absorber. The following sizes for different absorbers are available:
Order-No. Active area Absorber Notes
159 00 11 Ø 68 mm 2-4 mm plastic transparent
159 00 13 Ø 106 mm 2-4 mm plastic transparent
159 00 05 Ø 44 mm 3 mm aluminium non-transparent
159 00 08 Ø 44 mm 2-4 mm plastic non-transparent
159 00 09 Ø 72 mm 2.8 mm aluminium non-transparent
159 00 12 Ø 72 mm 2-4 mm plastic non-transparent
Table 1: Circular ionization chambers

Operation Manual
VacuDAP 2002
2002BA01e.DOC / 22.07.2004 7of 22
The ionization chamber is intended for the installation within the collimator (behind the beam limiting
device). If the reference direction of incident radiation is specified in the annexed data sheet of
ionization chamber it is crucial that the ionization chamber is installed accordingly.
The display unit should be put up or installed in a suitable place.
The ionization chamber is connected to the detector electronics. The female connector of the signal
line (cable 953 00 40) is connected to the male connector of the detector electronics and screw-
locked, whereas the male connector of the signal line is plugged into the 4-pole socket of the display
unit.
Make sure the cable is laid such that it is stress-relieved. The cable must
not restrict the movement of the arm supporting the X-ray source.
2.4 Function test
All components of the measuring system should have reached room
temperature before the function test is started.
If the VacuDAP 2002 measuring system was correctly installed the supply voltage can be applied.
After an initialisation phase, the measuring system starts the POWER-ON TEST (see 3.3.3, TEST
function) during which the correct connection and function of all system components are automatically
tested.
When the function test is correctly performed, the following messages - among others - will be
displayed:
VACUDAP
:
TEST OK
RESET
0
and the VacuDAP 2002 measuring system switches to the MEASURE mode.
In case of a trouble, an error message with an up to four digit number (shown as xxxx), which
characterizes the trouble, will be displayed:
ERR:xxxx
One cause of this message may be an incorrect installation of the system. Troubleshooting should be
performed as described in Chapter 5.1, Error codes and troubleshooting.
2.5 Installation and testing of accessories
Any accessories supplied with the system (e.g. a printer) are connected to the serial interface of the
display unit with the associated cable (see 6, Accessories and options) which is plugged into the 5-
pole socket of the unit. For any other installation work see the descriptions supplied with the
respective equipment.

Operation Manual
VacuDAP 2002
2002BA01e.DOC / 22.07.2004 8of 22
The correct installation of a printer can be verified by a test . For this purpose, the system must be set
for the MEASURE function, i.e. the POWER-ON TEST was successfully executed.
Press key
Print
for starting the test (see 3.3.6, PRINT function).
2.6 Stabilization time
The ionization chamber is a highly sensitive detector. After application of the chamber voltage, it
needs some time to form and stabilize before the performance characteristics specified in the data
sheet are met. This time is called stabilization time.
Unless otherwise specified in the data sheet for the ionization chamber, a
stabilization time of 3 minutes is required.
The measuring system is ready for measurements before this time has elapsed.
2.7 Factory calibration
By means of a calibrated reference system (IEC 61674), the VacuDAP 2002 measuring system is
calibrated by the manufacturer in line with IEC 60580:2000, and meets all specifications as detailed in
the annexes.
The calibration is carried out at 70 kV, 100 mAs, with the specified absorber (see Table 1: Circular
ionization chambers) in the beam path between the measuring chamber and the patient.
Ionization chamber and detector electronics with the same serial
number are calibrated together by the manufacturer. A re-calibration is
necessary if ionization chamber and detector electronics with different
serial numbers are used together (see 4.4, Checking the overall
calibration).
For a correct measurement of the dose area product, no additional
accessories such as absorbers or beam limiting devices may be inserted
in the beam path between the ionization chamber and the patient
In case an absorber is permanently arranged between the ionization
chamber and the patient, it needs to be taken into account in the dose
area product measurement.
The display unit has two different calibration factors (CF_ABOVE, CF_UNDER ), which can be
selected by switching parameter POSITION to either ABOVE (above table, without absorber) or
UNDER (below table, with absorber). This selection is described in Chapter 3.3.9. Changing of
parameters. The factory-set values for the calibration factors are shown in Table 7: List of parameters.
The second calibration factor, CF_UNDER was determined with an additional 0.5 mm aluminium
absorber for type tests (see annex: Data sheet of ionization chamber).
For regular switching between radiological examinations with and without absorber, the required
calibration factor must be selected by switching parameter POSITION accordingly.
By a re-calibration procedure authorized personnel can adjust the two calibration factors to the
prevailing installation conditions; see the instructions in Chapter 4.4, Checking the overall calibration.

Operation Manual
VacuDAP 2002
2002BA01e.DOC / 22.07.2004 9of 22
3 Operating instructions
3.1 General
The VacuDAP 2002 measuring system is used for measuring the dose area product (DAP), which is a
direct measure of the radiation a patient is exposed to.
The measuring chamber is inserted in the collimator; it does not affect routine operation in any way.
As compared with measuring the incident radiation dose, the measurement of the dose area product
allows the influencing variables, dose rate, irradiation time and field size used to be determined. The
system measures the entire radiation received by the ionization chamber and accumulated within a
time which is started by pressing
Reset
.
3.2 Components and measuring principle
Fig. 1: Components of the VacuDAP 2002 measuring system
Within the ionization chamber (1), the X-rays produce charge carriers which are proportional to the
product of dose and X-rayed ionization chamber area. The small measuring currents so generated are
amplified and digitised by the detector electronics (2). The digital measuring signal is transmitted to
the display unit (3) where it is further processed and displayed.
3.2.1 Ionization chamber and detector electronics
The compact design of ionization chamber and detector electronics allow the installation inside the
collimator of the X-ray unit.The transparent ionization chambers are intended for use on X-ray
equipment with light beam diaphragm.
The electronic components include, among others, the chamber voltage generator, a charge amplifier
and a microprocessor. A signal cable is used for transmitting the measuring signal to the display unit.

Operation Manual
VacuDAP 2002
2002BA01e.DOC / 22.07.2004 10 of 22
3.2.2 Display units, connections and control elements
Display units can be supplied with different housings; see Table 2.
The following connections are found on the rear sides of the units:
• Input: voltage supply (plug-in power pack)
• Input (4-pole socket): measuring signal from the detector electronics
• Output (5-pole socket): serial interface RS-232 (for printer or PC)
The measured values (in mGy*cm²) are displayed by a high-intensity, 8-digit LED display. The readout
resolution is 1 mGy*cm.
The measuring system is operated by using the two keys
Print
and
Reset
on the keypad.
Built-in unit 952 00 02
• for incorporation in operator consoles
• sturdy, compact housing
• RS-232 for printer or PC
Table-top unit 953 00 01
• standard unit
• compact housing
• RS-232 for printer or PC
• alternatively, as wall-mounted unit (953 00 02)
Table-top unit 956 00 01
• for 2-channel measuring system
• simultaneous, independent measurements
• compact housing
• common RS-232 for printer or PC
Table 2: Display units