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Dosimax plus A

Dosimeter

User Manual
Manufacturer : Iba Dosimetry GmbH
Address : Bahnhofstraße 5, DE­90592 Schwarzenbruck
VAT­No. : DE132815519
WEEE­Reg.­No. : DE 65960409

Note:

The intended use of the equipment is clearly defined on the following pages. Each
deviating use leads to a risk.

0124

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Table of Contents
Page
Table of Contents ...................................................................................................................3
1 Introduction .....................................................................................................................4
1.1. Short description of the DOSIMAX plus A.................................................................4
1.2. Intended Use............................................................................................................5
1.3. User Restrictions......................................................................................................5
1.4. Environmental Conditions.........................................................................................6
2 System components........................................................................................................7
2.1. Standard components ..............................................................................................7
Accessories (optional).........................................................................................................8
3 Operating instructions .....................................................................................................9
3.1. ON/OFF key .............................................................................................................9
3.2. PARAMETER keys...................................................................................................9
3.2.1. DOSE key .........................................................................................................9
3.2.2. DOSERATE key................................................................................................9
3.2.3. TIME key.........................................................................................................10
4 Measuring Setup ...........................................................................................................11
4.1. General Procedure .................................................................................................11
4.2. Practical hints.........................................................................................................12
5 Measurements ..............................................................................................................12
5.1. Dose measurement ................................................................................................12
6 Changing the batteries ..................................................................................................14
7 Technical Data ..............................................................................................................15
7.1. Basic instrument.....................................................................................................15
7.2. Detector RQA.........................................................................................................16
8 Quality Assurance Tests................................................................................................18
9 Troubleshooting – Error indications ...............................................................................19
10 Warranty .......................................................................................................................19
10.1. General...............................................................................................................19
10.2. Warranty period ..................................................................................................20
10.3. Limitations ..........................................................................................................20
10.4. Consequential damage or personal injury ...........................................................20
11 Disposal / Recycling ......................................................................................................20
12 Index .............................................................................................................................22

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1 Introduction

1.1. Short description of the DOSIMAX plus A


The DOSIMAX plus A dosimeter is a fully automatic precision instrument for measuring
dose, dose rate and exposure time simultaneously. Semi­conductor detectors are used
which offer, in comparison to ionization chambers, a number of well­known advantages e.g.
they are unaffected by air pressure and temperature. The ionization current of the semi­
conductor detector is measured, converted into the dosimetrical unit Gray (Gy) and then
shown in the display.

The DOSIMAX plus A has the following features:

· Automatic sensitivity change­over between radiography and fluoroscopy


· Automatic reset
· Easy parameter selection by using the corresponding key
· Direct readout of measured values
· Auto Power­Off after a period of 10 minutes when no user interaction or
measuring takes place.

The following detectors can be used in connection with the DOSIMAX plus A:

· Detector RQA, a separate external detector used in conventional radiology

The DOSIMAX plus A is, by default, calibrated using the RQA detector.

The calibrated beam quality for the RQA­detector you will see in the following table.

Filtration
Beam Quality Voltage [kV]
[mm Al]
RQR 5 70 2,5
RQA 5 70 25

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Important Note
This manual contains information necessary to use the DOSIMAX plus A and associated
detector(s) safely and effectively.

The DOSIMAX plus A should not be used until the operator is familiar with the contents of
this manual and particularly the sections prefixed with "Important", "Caution" or "Warning“
printed in bold text.

1.2. Intended Use


The DOSIMAX plus A is intended for measuring in the being of use beam in the context of
the acceptance test according to radiograph ordinance to radiograph diagnostics facilities.

1.3. User Restrictions

The DOSIMAX plus A is a medical device compliant with the German Medicine Product Law
and as such must, in Germany, undergo a two yearly check of it’s accuracy and general
condition. The instrument is developed on base of the IEC 61674. With this in mind please
ensure that all local regulations and laws applicable to the use of a product of this type in
your country are also adhered to.

Important ­ Incident reporting:

If the system is involved or associated directly or indirectly with a hazardous incident it


should be withdrawn from service immediately and the details reported to the manufacturer.

Copyright
A copy of this manual is supplied with each DOSIMAX plus A system to ensure correct
operation. It must not be copied in part or in whole, or used for any other purpose
without the written permission of the manufacturer.

Caution! Patent Infringement.


Several features of the DOSIMAX plus A and its component accessories are subject to
patent applications.

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Warning! Unauthorised Changes

Modifications to the product or the content of this manual will invalidate the product
warranty and may compromise safe operation. Do not therefore, under any
circumstances, make any changes to the product or its component accessories.
Every effort has been made to ensure that this manual is sufficiently accurate for its
intended purpose. The manufacturer would appreciate being informed of possible
errors and suggestions for improvements.

1.4. Environmental Conditions

Allowed Environmental Conditions

Working temperature range: 15 °C ­ 35 °C


Humidity: < 80 %
Pressure: 700 hPa – 1060 hPa

Reference Range (Factory Calibration)

Temperature: 20 C°
Humidity: 20 % ­ 75 %, ≤ 20 g/m3
Pressure: 800 ­ 1060 hPa

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2 System components

2.1. Standard components


The DOSIMAX plus A measuring system consists of a basic measuring and display unit and
one or two detectors:

Figure 1: DOSIMAX plus A – basic instrument

Figure 2: Detector RQA. A flexible sensor for radiographic measurements.

( select the RQA detector in this set)

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Accessories (optional)

Figure 3: Detector extension cable, 8 m

Figure 4: Cassette­Shaped Adapter for the RQA detector

The dosimeter – detector combination can be used with different types of test devices, e.g.
the detector RQM with the mammography test device MAMMO­152.

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3 Operating instructions

The basic unit has four keys, one ON/OFF key and three parameter keys.

3.1. ON/OFF key

The instrument is activated by pressing the ON/OFF key.


If the DOSIMAX plus A is not used for longer than 10 minutes (no radiation detection or
pressing of any key), the device switches itself off automatically (battery saving function).
The display lighting switches itself off after 3 minutes. It is activated again either after
radiation detection or by pressing a key.

3.2. PARAMETER keys

3.2.1. DOSE key


The “DOSE”­Key is used in order to indicate the dose value of the preceding exposure in
the display (Figure 2).

Figure 2

3.2.2. DOSERATE key


The “DOSERATE”­Key is used in order to indicate the dose rate of the preceding exposure
in the display (Figure 3).

Figure 3

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3.2.3. TIME key

The “TIME”­Key is used in order to indicate the exposure time of the preceding exposure in
the display (Figure 4).

Figure 4

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4 Measuring Setup

4.1. General Procedure


The DOSIMAX plus A was developed to measure dose, dose rate and exposure time
simultaneoulsly, fast and simply, but with the highest precision.

The measuring procedure is very easy:

· Position the chosen detector in the field of radiation (central beam) and make sure
that the marked side of the detector is facing towards the X­ray tube.

· Switch on the DOSIMAX plus A by pressing the ON/Off key. Straight away a selftest
(the “IBA DOSIMETRY” logo appears first) will appear. The following display
messages show the user the firmware­version and the serial number of the basic
DOSIMAX plus A unit. Additionally, if the Instrument is programmed to use more
than one detector, the following screen appears:

· You can switch to another calibrated sensor with the time­button. When the desired
sensor is displayed please select it by depressing the dose­button.
· When the “DOSE” indication (this is the default message) appears, the instrument is
ready to start taking measurements.
· Start an exposure and:
o Select with the “DOSE” key the dose indication or
o Select with the “DOSERATE” key the dose rate indication or
o Select with the “TIME” key the time indication
and read off the measured values.

After each exposure the chosen parameter and its corresponding unit of measurement is
clearly visible in the display.

During each new exposure an automatic RESET of the device takes place.

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4.2. Practical hints
Please note that an accurate measurement result pre­supposes that the entire detector
surface is irradiated. The active detector surfaces can be made particularly small by the use
of high resolution silicon semiconductors.

Due to the high sensitivity of the detectors, it is possible that a triggering can take place
without the effect of radiation (e.g. through a shifting current value in the cable when
mechanically moved). Therefore neither the detector/s or the measuring cable should be
moved, or suspended in a way that a mechanical influence can occur, during the power on
phase or during the taking of measurements.

The DOSIMAX plus A basic unit is calibrated using the detector RQA with 70 kV and a total
filtration of 2.5 mm aluminium ( beam quality RQR 5 according to DIN EN 61267) at a
distance of 1 m. The detailed calibration conditions are given in the enclosed calibration
certifcate.

5 Measurements

5.1. Dose measurement


The dose measurement in the radiographic mode is started as soon as the minimal specified
doserateis exceeded. On the display the actual DOSE appears. (Figure 5). An “M” in the top
line of the display indicates that a signal has been recognized. The measurement is
terminated after a time interval of 2 s without radiation detection run off.

Figure 5

After measurement the dose value is indicated (Figure 6).

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Figure 6

By pressing the DOSERATE­Button, the dose rate and the time value is indicated
(Figure 7).

Figure 7

By pressing the TIME­Button, the time value is indicated


(Figure 8).

Figure 8

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6 Changing the batteries

By means of the battery symbol the battery status can be verified.

If the capacity of the batteries is too low, measurements are no longer possible.

If the battery symbol flashes , the batteries must be changed immediately.


Commercial AA batteries (Mignon) can be used, whereas alkaline batteries LR 6 are
preferred because a longer function period is possible. In order to change the batteries, you
must carefully slide the battery compartment lid downwards (Figure 9).

Figure 9

Exchange the batteries and close the lid again.

The use of rechargable batteries (Accumulators) is not recommended.

Note: If you do not intend to use the DOSIMAX plus A for a longer period of time, please
remove the batteries before storage.

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7 Technical Data

7.1. Basic instrument


Wave form: 1­pulse up to middle frequency / high frequency
generators

Exposure time: 1 ms to 19999 s


Reset: automatically
Switching Off: automatically after 10 minutes of inactivity or by use of
the Off key

Interface: RS 232
Power supply: 4 Mignon batteries (AA) 1,5V each or alkaline (LR6)
Working time: 15 hours (alkaline batteries)
Display: LCD­DOT­Matrix, 5 Digits and units
Weight: 280 g / 0.44 lb (basic equipment without batteries)
290 g / 0.64 lb (basic equipment with batteries)

Size (H x W x L):
Dosimeter: 35 x 90 x 145 mm, (1.4’ x 3.5’ x 5.8’)

Operating temperature: 15 to 35 °C (59 to 95 °F), Storage: 0 bis + 60 °C (32 to


140 ° F)

Relative air humidity: < 80 %

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7.2. Detector RQA

Type of detector: Silicon photodiode (PIN)


Measurement principle: Ionization current in the semiconductor detector
Detector patch cord: Triaxial plug type Lemosa, size 0
Nominal measuring range for 50­150 kV tube voltage in the unattenuated
diagnostic beam qualities: useful beam (RQR 3 – RQR 10, acc. DIN EN
61267)

50­150 kV tube voltage in the attenuated useful


beam (RQA 3 ­ RQA 10, acc. DIN EN 61267)

Calibration factor: 0.0188 mGy/nC (70 kV, 2.5 mm Al)


0.0174 mGy/nC (70 kV, 25 mm Al)

Response: 53.2 nC/mGy (70 kV, 2.5 mm Al)


57.5 nC/mGy (70 kV, 25 mm Al)

Dose measuring range: 200 nGy bis 9999 mGy


for the Dose rate range: 80 nGy/s bis 70 mGy/s
Measurement uncertainty: < 5 % (by a minimal dose rate of 80 nGy/s)
Weight: 85 g (0.18 lb)
Size (L x W x H): 45 x 20 x 8 mm (1.7’ x 0.78’ x 0.31’)

Maximum cable length: 10 m (394’)


Calibration reference point: 70 kV, 2.5 mm Al, 1 m distance (RQR5)
70 kV, 25 mm Al, 1 m distance (RQA5)

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1. HVL Filtration
Beam quality voltage [kV] Cq
[mm Al] [mm Al]
RQR 3 50 1,8 2.5 1.015
RQR 4 60 2,0 2.5 1.008
RQR 5 70 2,5 2.5 1.000
RQR 6 80 2,9 2.5 0.992
RQR 7 90 3,3 2.5 0.986
RQR 8 100 3,7 2.5 0.982
RQR 9 120 4,5 2.5 0.979
RQR 10 150 5,7 2,5 0,987

1. FWHM Filtering [mm


Beam quality voltage [kV] Cq
[mm Al] Al]
RQA 3 50 3,8 2,5 + 10 1,016
RQA 4 60 5,4 2,5 + 16 1,016
RQA 5 70 6,8 2,5 + 21 1,000
RQA 6 80 8,2 2,5 + 26 0,975
RQA 7 90 9,2 2,5 + 30 0,962
RQA 8 100 10,1 2,5 + 34 0,957
RQA 9 120 11,6 2,5 + 40 0,964
RQA 10 150 12,8 2,5 + 45 1,011

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8 Quality Assurance Tests

Even if a self check of the DOSIMAX plus A dosimeter ­ detector combination is done after
every switch­on, QA tests should be carried out at regular intervals in order to verify the
general functionality, safety and general condition of the dosimeter, the detector(s) and all
accessories. Please observe the environmental reference conditions stated below.

Suggested time table for QA tests

Type of test Frequency Tolerance

Calibration Every 2 years +/­ 5 %

Dosimeter is free of damage Before every


together with exposed cables / messuring
detector(s) session

Remarks:

The named quality assurance tests are recommondations only.


International standards and national laws must be observed.

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9 Troubleshooting – Error indications

Generally, the DOSIMAX plus A has been designed to have a long reliable life. If a problem
is noticed with a measuring system, it may not just be caused by the detector assembly, but
also by the display, processor, power supply or interconnecting cables.

The following error indications can appear on the display if the measuring conditions were
incorrect:

*OVERFLOW* : High dose rate, reduce mA or increase the focus detector


distance.
Problems other than those indicated above will probably require fault correction by the
manufacturer. Please report the problem to your local supplier who will arrange for the
product to be returned for repair.

10 Warranty

10.1. General
Iba Dosimetry GmbH warrants the DOSIMAX plus A and associated accessories to be free
of defects within the warranty period. In case of a defect, Iba Dosimetry GmbH will correct
the fault or replace the product at no cost for the owner. In the case of a fault, the owner
should first report the problem to the supplier, or the manufacturer, Iba Dosimetry GmbH.
The following information must be given in order to claim under warranty:
v The nature of the problem
v The date the product was purchased
v The model number of the item which is faulty
v The serial number of the item which is faulty

The cost of packing and shipping goods for return shall be the responsibility of the owner
unless otherwise agreed in writing prior to shipment. Any damage caused to returned goods

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during shipment shall be the responsibility of the owner. On receipt of the goods the
manufacturer will carry out an inspection to confirm that the problem is covered by this
warranty. In cases were the problem is not covered by warranty, the owner will receive a
quotation for repair. All warranty work will be completed within twenty one days of receipt of
the goods, or the item will be replaced.
The terms of this warranty do not affect the owners’ statutory rights under applicable national
or local legislation or claims against a local supplier arising from a sale or purchase contract.
Claims of this nature should be addressed to the supplier.

10.2. Warranty period


The normal warranty period for all items is 12 months from the date of purchase;
Other periods must be agreed in the written form.

10.3. Limitations
The warranty does not cover the following.
v Periodic checks, calibrations or preventive maintenance.
v Defects with equipment which has been modified without the
written approval of the manufacturer.
v Damage resulting from normal wear and tear.
v Damage resulting from improper use or handling including, but not
limited to, the product being dropped or incorrectly installed.
v Accidents or disasters which are beyond the control of the
manufacturer, including, but not limited to lightning, fire, public
disturbances and improper ventilation.
v
10.4. Consequential damage or personal injury
The manufacturer will not accept liability for consequential damage or personal injury
resulting from the use of the product, whether fully functional or faulty, until such time as
regulatory and legal authorities have established negligence on the part of the manufacturer.

Note: It is the users responsibility to follow the guidance given in this user manual
together with established professional practice to ensure that the product is
in a usable condition and is being used correctly.

11 Disposal / Recycling
This measuring device and its accessories contain electronic components, e.g. the liquid
crystal display unit or the rechargeable batteries.
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When the useful life of the measuring system draws to an end, one should not dispose of it
by just discarding it into the waste disposal system of a General Hospital or into the trash
collection of a private residence. If you do not have an established procedure for the
recycling of electronic waste at the end of its product life then you should return the system
to Iba Dosimetry GmbH where we can recycle the product in a way which is appropriate
and also respectful to the environment.

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12 Index
Overflow 19
A
P
AA­batteries (Mignon) 14
Accessories 8 Power on Phase 12
Alkali Cells 14 Power supply 15
Automatic Reset Function 11 Practical hints 12

B Q
Basic instrument, technical data 15 Quality Assurance Tests 18
Battery Change 14
Battery Status 14 R
Radioscopy Operation 13
C
Record mode 12
calibration 12 Recycling 21
RQX­Detektor, specification 16
D
S
Disposal 21
DOSE­Key 9, 11 Selftest 11, 18
DOSERATE­Key 9, 11 Standard components 7
Storage 14
E System components 7

Environmental Conditions 6
T
Error indications 19
Technical Data 15
I Threshold 12
TIME­Key 10, 11
Intended use 5 Troubleshooting 19
Interface 15

U
M
User restrictions 5
Measuring Procedure 11
Measuring Setup 11
W
Mechanical load 12
Warranty 19
O
ON/OFF key 9

VD UM DOSIMAX plus A 002

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IBA Dosimetry GmbH
Bahnhofstraße 5 | 90592 Schwarzenbruck | Germany | Tel.: +49 9128 607 14 | Fax: +49 9128 607 814

www.iba­dosimetry.com | info@iba­dosimetry.com

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