PTW DIADOS E User Manual

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2015-10 Hn/Az
User Manual
DIADOS E
T11035
firmware 1.30 or higher
Contents
Operating Manual
Technical Manual
Service Manual
D616.131.00/10 en
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DIADOS E
T11035
General Information
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General Information

The product bears the CE-mark "CE-0124" in
accordance with the Council Directive 93/42/EEC about Medical Devices and fulfills the essential requirements of Annex 1 of this directive. The product is a class IIb device (MDD).
The product was granted the type approval as
diagnostic dosemeter DIADOS E in accord­ance with § 13 of the German Verification Act (Eichgesetz) by the German National Metrolo­gy Institute (Physikalisch-Technische Bun­desanstalt, PTB) in Braunschweig. For de­tailed information, refer to section "Technical Specifications".
Product standard
The product fully complies with the require­ments of the following standard IEC 61674.
Electrical safety
The product fully complies with the require­ments of the following standard IEC 61010-1.
Electromagnetic immunity
The product fully complies with the require­ments of the following standards: IEC 61326-1 / IEC 61674.
The user manual is an integral part of the
product. It should always be kept near the product. Observance of the manual is a pre­requisite for proper product performance and correct operation.
Operator safety, specified measuring accuracy
and interference-free operation can be guaran­teed only if original products and parts are used. Furthermore only the accessories listed in this manual are approved by PTW-Freiburg and may be used in conjunction with the prod­uct, or else accessories whose use has been expressly permitted by PTW-Freiburg. Safe operation and proper product performance are not guaranteed if accessories or consumables from other manufacturers are used.
PTW-Freiburg cannot be held liable for dam-
ages resulting from the use of accessories, consumables from other manufacturers or when the user ignores the instructions and in­formation given in this manual.
The warranty period is 1 (one) year and begins
on the day of delivery. It is unaffected by re­pairs covered by the warranty regulations.
PTW-Freiburg considers itself responsible for
safety, reliability and performance of the prod­uct only, if assembly, extension, readjustment, modification or repair is carried out by PTW­Freiburg or by persons authorized by PTW­Freiburg, and if the product is used in compli­ance with the technical documentation.
In case of any questions concerning service,
support or warranty please contact your sup­plier.
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General Information
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This manual is in conformity with the device
specifications and all applicable safety stand­ards valid at the time of printing. All rights are reserved for devices, circuits, techniques, software programs, and names appearing in this manual.
PTW-Freiburg reserves the right to make mod-
ifications. Please contact PTW or your local representa­tive for the most current information concern­ing the products of interest.
No part of the technical documentation may be
reproduced without written permission from PTW-Freiburg.
PTW-Freiburg is registered manufacturer ac-
cording to the ElektroG (Elektro- und Elektro­nikgeräte-Gesetz). Elektro-Altgeräte-Register (EAR) Registration number DE15599992
PTW-Freiburg
Physikalisch-Technische Werkstätten Dr. Pychlau GmbH Lörracher Str. 7 79115 FREIBURG GERMANY Phone: +49 761 49055-0 Fax: +49 761 49055-70 info@ptw.de www.ptw.de
PTW-Freiburg works in strict accordance with
a quality management system which is contin­uously updated according to national and in­ternational standards.
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Contents
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Contents

General Information 2 Contents 4 Illustrations 5 Intended Use 6 Safety Information 6
Operating Manual 11
1 Description of the Device 11
1.1 General Features 11
1.2 Connection Panel 12
1.3 Display 12
1.4 Keypad 13
1.5 Control Keys/Functions 14
2 Putting the System into Operation 19
2.1 Inserting the Rechargeable Batteries 19
2.2 Putting DIADOS E into Operation 20
2.3 Connecting the Detector 20
2.4 Positioning DIADOS E 21
2.5 Basic Settings (Setup Menu) 22
2.6 Modes of Operation 23
2.7 Measuring Quantities 23
2.8 Measuring Ranges 25
2.9 Digital Resolution 27
2.10 Entering the Chamber Calibration Factor 27
3 DIADOS E – Brief Operating Instructions 28 4 Performing a Measurement 29
4.1 General Information for Measurements 29
4.2 Dose, Dose Rate and Dose per Pulse Measurement 29
4.3 Charge and Current Measurement 32
4.4 Measurements in Computed Tomography 34
4.5 Measurement at Dental X-ray Units 35
5 Error Messages and Troubleshooting 37
5.1 Equipment Error Messages 37
5.2 Problems during Operation 38
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Illustrations
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Technical Manual 39
6 Technical Specifications 39
Service Manual 43
7 Cleaning 43 8 Maintenance 44
8.1 Checks before each use 44
8.2 Repair 44
8.3 Safety Inspections 44
8.4 Technical Inspections of the Measuring System 44
8.5 Maintenance of Officially Calibrated Dosemeters 45
8.6 Calibration 45
8.7 Rechargeable Batteries 45
9 Disposal of the Product 47 Literature 48 Appendix A: China Electronic Industry Standard Compliance 49 Index 51

Illustrations

Figure 1: Definition of patient environment 10 Figure 2: DIADOS E connection Panel 12 Figure 3: DIADOS E display 12 Figure 4: DIADOS E keypad 13 Figure 5: Timer function 18 Figure 6: Mounting the rechargeable batteries 19 Figure 7: Setup menu 1/2 22 Figure 8: Setup menu 2/2 22 Figure 9: Calibration data menu 1/4 22 Figure 10: Calibration data menu 2/4 22 Figure 11: Calibration data menu 3/4 22 Figure 12: Calibration data menu 3/4 22 Figure 13: Calibration data menu, example for the RAD application 23 Figure 14: DIADOS E display for radiological measurements 29 Figure 15: Display in electrometer mode 32
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Intended Use
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NOTE
Please observe the user manuals of all connect­ed detectors!
This is the safety alert symbol. It is used to alert the user to potential hazards. Obey all safety messages that follow this symbol to avoid possible bodily injury or equipment damage.
DANGER
Indicates an imminent hazard. If not avoided, the hazard will result in death or serious injury.
WARNING
Indicates a hazard. If not avoided, the hazard can result in death or serious injury.
CAUTION
Indicates a potential hazard. If not avoided, the hazard could result in minor injury or product / property damage.
NOTE
Provides useful information to assure that you get the most from your equipment.

Intended Use

DIADOS E is a diagnostic dosemeter according to IEC 61674 and can be used for acceptance testing and constancy checks. It can be employed in con­ventional X-ray diagnostics, in dental and mammo­graphic applications as well as with CT systems. DIADOS E is capable of measuring dose and dose rate in diagnostic X-ray applications, dose length product and the dose length product rate in CT applications and current and charge if used as elec­trometer. DIADOS E is capable of measuring in front of and behind phantoms.
The following detectors are required for the meas­urement:
DIADOS Diagnostic Detector T60004 for con-
ventional diagnostic radiology and for dental im­aging
DIADOS MAM Detector T60005 for mammogra-
phy
CT ion chamber 3.14 cm³ TM30009 with CT
adapter T16018

Safety Information

All safety messages consist of the following com­ponents:
Safety alert symbol and signal word Type of danger Source of danger Consequence Measures to prevent hazard
Signal Words
CT ion chamber 300 mm long TM30017 with CT
adapter T16018
Note: In the United States, federal law restricts
this device to sale by or on the order of a physician.
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DANGER
Operation in areas where an explosion hazard may occur or in oxygen-enriched atmospheres
Explosion Hazard!
The product is not suitable for operation in areas of risk where an explosion hazard may occur. Explosion hazards may be caused by the use of combustible anaesthetics, skin-cleansing agents and disinfectants.
Furthermore the product is not suitable for appli­cation in oxygen-enriched atmospheres. The atmosphere is considered to be oxygen-enriched when more than 25 % of oxygen or nitrous oxide is added to the ambient air.
WARNING
Electricity is a source of risk, particularly when the product is not in perfect operating condition or when it is operated inappropriately.
Shock Hazard!
Strictly observe the following warnings. Failure to do so may endanger the lives of the patient, the user and other persons involved.
Before using the product, the user must as-
certain that it is in correct working order and operating condition.
Before putting the device into operation, visu-
ally inspect all connection cables for signs of damage. Damaged cables and connectors must be replaced immediately.
When disconnecting the device from the pow-
er line, first remove the plug from the wall out­let, then disconnect the power cord from the device.
WARNING
Devices on which moisture condensation has
developed as a result of temperature changes must not be switched on unless completely dry.
Liquids must not enter the product. If liquids
have entered the product, it must be thor­oughly inspected before being used again.
The product is a device of IEC 61140 protec-
tion class II.
Extension cords must not be used. All devices of a system must be connected to
the same electric circuit. Devices which are not connected to the same circuit must be electrically isolated (use RS232 interface with galvanic insulation).
Exclusion of operation in the patient envi­ronment: Neither the product nor any peripheral
devices may be operated in the patient environ­ment (see Figure 1).
Exclusion of operation as device with patient contact: The device is not intended for use in
direct contact with the patient. Neither the device nor any peripheral device may have contact to the patient.
Never touch the patient and open connectors of the device at the same time.
Exclusion of operation as controlling instru­ment: The device is only designed for use as a
measuring device. The device must not be used to control radiodiagnostic equipment or radio­therapy units.
Safety Information
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WARNING
Use of peripheral devices: Peripheral devices
(PC, printer) may only be connected if they meet the requirements of UL 60950-1/IEC 60950-1 or of standard IEC 61010-1.
Devices may be connected to other devices or to parts of systems only if it has been ascertained that this connection does not impair the safety of the patient, the operator or the environment.
If the device specifications do not contain infor­mation as to connecting the device to other equipment, you must consult the manufacturer of the other equipment or an expert about the ef­fects of the connection on the patient, the opera­tor or the environment. Always observe standard IEC 61010-1.
WARNING
Improper handling.
Patient Hazard!
The product is a medical electrical device and must only be handled by persons who are trained in the use of such equipment and are capable of applying it properly. The operator must be trained in the use of the device.
WARNING
Magnetic and electrical fields are capable of in­terfering with the proper performance of the de­vice.
Equipment Failure!
For this reason make sure that all external
devices operated in the vicinity of the device comply with the relevant EMC requirements. X-ray equipment, MRI devices and radio sys­tems are possible sources of interference as they may emit higher levels of electromagnet­ic radiation. Keep the device away from these devices and verify its performance before use.
The use of cables longer than specified may
impair the electromagnetic compatibility char­acteristics of the device.
The device should not be used in the immedi-
ate vicinity of or placed on top of or below other equipment. However, if the application requires an arrangement of devices as de­scribed above, the device should be watched to ensure its proper functioning in the specific arrangement.
The customer or user of the device should as­sure that it is used in an electromagnetic envi­ronment as described in IEC 61326-1.
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CAUTION
Use of the product without observing the user manual.
Bodily Injury! Equipment Damage!
Always use the product in compliance with the user manual. Otherwise the intended protection can be reduced.
Use the product only in conjunction with the de­vices approved for this purpose by PTW and/or the devices listed in the section "Intended Use".
Handle the product with care to avoid equipment damage.
CAUTION
Operation under inadequate ambient conditions.
Equipment Damage!
Before connecting the device to the power line, make sure that line voltage and frequency are equivalent to the ratings indicated on the name­plate of the device.
Set up the device in a location which affords sufficient ventilation.
Always observe the ambient conditions as indi­cated in the `Technical Specifications`.
CAUTION
Improper handling of cables and connectors.
Equipment Damage!
To avoid damage to the cables and connectors, observe the following points.
Do not kink the cables. Observe the minimum
bend radius of the cables. Never exert pres­sure on the cables. Do not step on the cables. Do not roll trolleys over the cables. Do not pull or twist the cables.
Disconnect the cables from the devices during
transport and when the devices are not in use. Do not let the cables hang down unre­strained.
The connectors must always be clean. Do not
allow the connectors to lie on the floor. Al­ways protect connectors when pulling them through cable conduits.
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NOTE
Please observe the user manuals of all connect­ed devices!
NOTE
Set up the device so that the operator has a clear, unobstructed view of the control panel.
Symbol
Description
Please refer to the user manual! The product bears the CE-mark.
23.04
03.01
The product (T11035) was granted the type-approval under German law (refer also to the section "Technical Specifications").
Identification mark of an officially calibrated device according to the German Metrology and Verification Act (Mess- und Eichverordnung, MessEV)
The device is provided with a pro­tective insulation according to pro­tection class II.
The device is only suitable for use with direct current.
Manufacturer and date of manufac­ture
Reference number
Serial number
Separate collection of electrical and electronic equipment!
(refer also to the section “Disposal
of the Product”)
Labeling according to „Administra­tion on the Control of the Pollution caused by Electronic Information Products (ACPEIP)“ (China RoHS) (refer also to the Appendix)
Symbols on Product and Nameplate
Figure 1: Definition of patient environment
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CAUTION
Direct or scattered radiation
Equipment Damage!
Do not expose the DIADOS E to direct or
scattered radiation.
Do not store the DIADOS E in the treatment
room.
CAUTION
Improper handling.
Equipment Damage!
The DIADOS E is a sensitive measurement de­vice, which needs regular checks and calibra­tions.
Make sure that the DIADOS E is checked
regularly according to section 8.
Have the DIADOS E calibrated by a qualified
laboratory at intervals of at most 2 years.

Operating Manual

1 Description of the Device

1.1 General Features

DIADOS E measures the dose, the dose rate, dose per pulse, time and pulse.
The Autostart function allows multiple consecutive measurements to be performed without any user intervention.
Selection of the measuring range is either automat­ic or manual.
The device is equipped with an RS232 interface.
DIADOS E is powered via a multi-range power sup­ply or from rechargeable batteries.
For officially calibrated dosemeters: On the side there is an official seal. If the official seal is damaged or removed, the official calibration will expire.
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DETECTOR
SERIAL
1 2 3 4
5 6 7 8

1.2 Connection Panel

1.3 Display

DIADOS E has connectors for the power supply (9 VDC) and for the detector (DETECTOR) and an RS232 interface (SERIAL) (see Figure 2).
As a general rule, the connector for the detector should be sealed with the enclosed cap when not in use.
Figure 2: DIADOS E connection Panel
While a measurement is in progress, the current dose/dose rate is indicated in intervals of 0.5 s.
The ALT key can be pressed to toggle between the different readouts during a measurement.
Figure 3: DIADOS E display
1 Resolution:
" " greater than 0.5 %, "*" greater than 1 %, "**" less than 1 %
2 Unit C, Gy or R; displayed in reverse video in
pulsed mode
3 Application:
RAD – convential radiology, DENT – dental application, CT – CT application or MamX/X – mammography (MamM/M, MamM/R, MamW/A, MamW/R, MamR/R, MamWAg)
4 Measuring range: Low, Med, High or Auto 5 Measuring value 6 Measurement status:
RDY – ready to take a measurement, RUN – measurement in progress, STA – measurement started with START/STOP, STP – measurement stopped with START/STOP, TST – measurement stopped by timer
7 Filter:
"Unatt." (without additional filtration) or "Att. " (with additional filtration)
8 Battery status: full/depleted
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Function
Effect
Comment
APPL.
selects the application RAD, DENT, CT, MamM/M, MamM/R, MamW/A, MamW/R, MamR/R, MamWAg
Only calibrated applications can be select­ed.
FILTER
toggles between the calibration factors in front of ↔ behind the phantom
combination of keys ALT + APPL.
MODE
toggles between pulsed mode ↔ normal mode
in the pulsed mode, the unit is displayed in reverse video
RANGE
toggles between the measuring ranges Auto Range, Low, Medium and High
combination of keys ALT + MODE RESET
resets the display to zero
STARDY, TSTRDY
ZERO
zero adjustment
combination of keys ALT + RESET
START/ STOP
manually starts/stops a dose measurement
ALT
activates the second function of a key toggles between dose, dose rate and time in
normal mode and between dose, dose/pulse and pulse in pulsed mode
You can toggle during and after the meas­urement.
ON/OFF
turns the device ON and OFF
push for 2 s
SETUP
brings up the Setup menu
combination of keys RESET + APPL.
 ,  
used to navigate in the Setup menu selects the sub-menu
ESC
used to exit the sub-menu/Setup menu

1.4 Keypad

Figure 4: DIADOS E keypad
The second function of a key (indicated in italics) is activated with the combination of ALT key + the re­spective key.
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1.5 Control Keys/Functions

1.5.4 Zero Adjustment (ZERO)

1.5.1 Turning the Device ON/OFF

ON/OFF key: push for 2 s to activate.

1.5.2 Starting and Stopping a Measurement (START/STOP)

The START/STOP key initiates and stops a meas­urement, even if no radiation is present.
The device has an Autostart feature. With Autostart, a measurement begins as soon as radiation is de­tected. The timer measurement is disabled.

1.5.3 RESET Key

RESET sets all parameter readings back to zero. RESET can also be used to clear an overload mes­sage “OL”. After activation of the RESET key, DIADOS E is in the Autostart mode.
The keys ALT + RESET will cause DIADOS E to perform a zero adjustment. For the zero adjust­ment, the detector and the extension cable used for the measurement must be connected. During this process, avoid moving or irradiating the detector and the cable. Perform the zero adjustment after setup and immediately before performing a meas-
urement. During zero adjustment the message “Ze-
roing” appears on the display, and the remaining
time in seconds is displayed.
The zero adjustment process can be aborted with the RESET key. In this case the previous device settings will be retained.
The zero adjustment should be repeated for follow­ing cases:
after changing the detector or after performing a reset the displayed value for
dose rate climbs up without radiation.
An automatic zero adjustment process can be aborted with the RESET key.
A measurement initiated with Autostart can also be aborted with RESET. All parameter readings will be reset to zero.
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NOTE
The recent draft of standard IEC 61674 does not provide different calibration factors for measure­ments with additional filtration and without addi­tional filtration in CT application.
For this reason DIADOS E contains the same calibration factor for measurements with addi­tional filtration (Att.) and without additional filtra­tion (Unatt.).
Thus pressing the ALT + APPL. keys has no effect in CT application.

1.5.5 Selecting the Application (APPL.)

The APPL. key is used to select the application range.
RAD: conventional diagnostics DENT: dental application CT: CT application MamX/X: mammography (MamM/M, MamM/R,
MamW/A, MamW/R, MamR/R, MamWAg)
The application can only be selected if a radiologi­cal unit is active (Setup menu).

1.5.6 Selecting the Filter/Calibration Factors (FILTER)

The function FILTER (keys ALT+APPL.) is used to select the filter/calibration factors necessary for the application. This function is active only when a radi­ological unit is selected (Setup menu). Two calibra­tion factors can be entered for each application, one for application with additional filtration (Att.) and one for application without additional filtration (Unatt.). The filtration value for application without additional filtration results from the inherent filtration of the system.
Only these applications are selectable which were calibrated radiologically. The registered calibration factor is unequal 0,000.
If not all qualities (maximum 12) are required, the user can deactivate a quality by entering the cali­bration factor 0 (refer to user manual RS232 Inter­face for PTW-DIADOS E“ D616.131.01). The reac­tivation is possible anytime, for it the calibration factor has to be taken from the calibration certifi­cate.
The choices depend on the selected application:
RAD: • 2.5 mm Al → Unatt.
• 23.5 mm Al → Att.
DENT: • 8.5 mm Al → Unatt.
• 8.5 mm Al + 0.5 mm Cu → Att.
CT: RQT9 0.25 mm Cu → Unatt.
RQT9 0.25 mm Cu → Att.
When used with mammography units, the use of
the second calibration factor for measurements behind the phantom is optional. For this reason DIADOS E contains the same calibration factor for measurements with additional filtration (Att.) and without additional filtration (Unatt.).
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1
MamM/M: • Mo/30 µm Mo → Unatt.
• Mo/30 µm Mo + 2 mm Al → Att. MamM/R: • Mo/25 µm Rh → Unatt.
• Mo/25 µm Rh + 2 mm Al → Att.

1.5.8 Selecting the Measuring Range (RANGE)

The measuring range is selected with the keys ALT + MODE.
MamW/R: • W/50 µm Rh → Unatt.
• W/50 µm Rh + 2 mm Al → Att. MamR/R1: • Rh/25 µm Rh → Unatt.
• Rh/25 µm Rh + 2 mm Al → Att. MamWAg: • W/50 µm Ag → Unatt.
• W/50 µm Ag + 2 mm Al → Att. MamW/A: • W/0,7 mm Al → Unatt.
• W/0,7 mm Al + 2 mm Al → Att. For mammography applications: The calibration
with 2 mm Al is only optionally available.

1.5.7 Changing the Operating Mode (MODE)

With MODE you toggle between normal and pulsed operation.
Normal mode Measured parameters are dose, dose rate and time. The timer function can also be used in this mode.
Pulsed mode In pulsed operation, the unit is displayed in reverse video (uppermost line on the display). Measured parameters are dose, dose per pulse and number of pulses.
The displayed value is the measuring value select­ed with the ALT key (see section 1.5.9).
a) Low
Low measuring range, suitable for fluoroscopy and measurements behind the phantom.
b) Medium
Medium measuring range, suitable for fluoros­copy and measurements in front of the phantom as well as for radiography and measurements behind the phantom.
c) High
High measuring range, suitable for radiography and measurements in front of the phantom.
d) Auto Range
Automatic adjustment of the measuring range; depending on the selected mode of operation, you will observe the following differences in the measurement and on the display:
In pulsed operation: The device defaults to the LOW range (display: AUTO L). When this range is exceeded, the message REPEAT appears on the display. At the end of this signal (at least the measuring de­lay time), the device selects the next higher level AUTO M. If the device overranges again due to an exces­sive signal, the message REPEAT appears again and the device selects the next higher level HIGH (display: Auto H). Dose and dose per pulse will not be indicated after overranging. On­ly the number of pulses is displayed.
Official calibration is not possible.
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In normal operation: Depending on the currently selected display (ALT key), the Auto Range function decides in an overrange condition whether to switch to the next higher range with REPEAT or whether to track the signal continuously. As in pulsed oper­ation, the initial, most sensitive range is AUTO L. If DIADOS E is in the dose rate mode at the time the overrange condition occurs, it will immedi­ately start switching ranges until the suitable range is found. If the range changes in the dose rate mode (e.g. from LOW to MED), the displayed dose value
will read “OL” because it could not be correctly
determined. After the end of the measurement, the dose rate readout will again begin with AUTO L.
If DIADOS E is displaying the dose or time when the overrange occurs, it will behave as in the pulsed operating mode: the message REPEAT appears after identification of the condition and the next higher range is selected after the measurement. After the end of the measurement and when the dose is displayed, the measuring range remains set until RESET is activated.

1.5.9 ALT Key

In combination with the keys APPL, MODE and RESET, ALT activates the second function as­signed to each key.
ALT + APPL. FILTER ALT + MODE RANGE ALT + RESET ZERO
During and after a measurement, you can use the ALT key to toggle between display of dose, dose rate and time in normal operation or of dose, dose per pulse and number of pulses in pulsed operation.
ALT can also be used to exit the Setup menu and the sub-menus. If you exit sub-menus with ALT, all changes in that sub-menu will be lost.

1.5.10 TIMER Function

Measurements with the timer are only possible in normal mode. Pressing the START/STOP key
disables the timer function.
Functional description: The timer function can be used to determine the average dose rate over an interval of 2 s or 20 s. To exclude the effects of switching on/off, the first 3 s and the last 3 s of the measuring interval will be ignored.
The measuring interval is determined by the end of the measurement (the measurement ends as soon as the measuring signal is removed).
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NOTE
Purpose of the timer interval “2 s”: You will select the 2 s timer interval if DIADOS E
is to continue indicating the dose rate after radia­tion has been removed (when the timer is off, the dose rate displayed after removal of radiation is
0.0).
NOTE
If the dose rate signal ends while the displayed time still blinks, the average is calculated on the basis of the existing values (with the exception of the first and last 3 s) and the corresponding measuring time is displayed. If the irradiation time is less than 6 s, DIADOS E will indicate a measured value of zero for dose rate, dose and time. The dose is calculated on the basis of the average dose rate and the irradiation interval.
Figure 5: Timer function
At the end of the measurement, the dose rate aver­aged over the timer interval will be indicated.
b) Determining the Average Dose Rate Over a
Period of 20 s:
The timer interval shall be set to 20 s (selection in the Setup menu). DIADOS E starts averaging 3 s after a dose rate signal has been detected, the displayed time blinks. The dose rate shall now be maintained constant until the time dis­played on DIADOS E stops blinking (this is the case after another 23 s). Radiation can now be removed. DIADOS E will display the dose rate averaged over the last 20 s of fluoroscopy, while ignoring the last 3 s.
Measuring tasks: a) Display of the dose rate value after removal
of radiation:
Recommended timer interval: 2 s (selection in the Setup menu). DIADOS E starts averaging 3 s after a dose rate signal has been detected, the displayed time blinks. The dose rate signal is required for another 5 s at minimum. The dis­played time stops blinking and DIADOS E stores the measured dose rate values which are aver­aged over 2 s in each case. When radiation is removed, DIADOS E will display the dose rate value measured 3 s before removal of radiation.
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DANGER
Improper handling of batteries.
Explosion Hazard!
Do not throw the rechargeable batteries into a fire.
WARNING
Improper handling of batteries.
Bodily injury!
If electrolyte leaks from the battery, avoid contact with skin or clothes. Immediately clean skin or clothes that have come in contact with electrolyte with water. In case of eye contact, immediately rinse eyes with water and consult doctor.
Do not open rechargeable batteries.
WARNING
Improper handling of batteries.
Risk of Fire or Skin Burns!
Never short the rechargeable batteries together.
CAUTION
Improper handling of batteries.
Equipment damage!
Do not open rechargeable batteries. Never ex­pose rechargeable batteries to water. Store and use the rechargeable batteries at the ambient conditions (temperature, relative humidity) speci­fied for the device.
CAUTION
Improper handling.
Equipment damage!
Do not operate the DIADOS E with disposable batteries. Use only the special rechargeable bat­teries.

2 Putting the System into Operation

2.1 Inserting the Rechargeable Batteries

On delivery, brand-new rechargeable NiMH batter­ies are enclosed to the DIADOS E. Before setup these new rechargeable batteries have to be insert­ed into the device and have to be charged. Due to their technology rechargeable batteries show a limited durability.
Therefore remove the lid from the battery com-
partment on the back of the device.
Insert the rechargeable batteries. For the num-
ber of batteries and the battery polarity refer to Figure 6.
Figure 6: Mounting the rechargeable batteries
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NOTE
New rechargeable batteries will reach their full capacity only after several charging and dis­charging cycles.
NOTE
The wall outlet for connection of the power sup­ply (power connector) should be within easy reach to allow the device to be easily discon­nected from mains.
NOTE
In CT applications (CT chamber and CT junc-
tion box) operate DIADOS E only on battery power, refer to section 2.3.2.
NOTE
Detector T60004:
The detector is suitable for use with and without brass absorber T20002.1.004. Measurements of the surface dose (entrance dose with backscatter) are performed without the brass absorber. Measurements of the entrance dose are per­formed with the brass absorber attached to the back of the detector.
Detector T60005:
This detector design only measures the entrance dose. Therefore, it is not necessary to attach a brass absorber to the back of the detector.
When used with X-ray units:
The overall length of the detector cable with ex­tension cable shall not exceed 10 meters.
NOTE
Also refer to the user manual of the DIADOS detectors.
Close the battery compartment.

2.3 Connecting the Detector

Perform an initial charging of the rechargeable
batteries of 23 hours. An overcharging of the re­chargeable batteries is not possible.
Then the DIADOS E will be ready for operation.
Please refer to section 8.7 for information about the safe handling of rechargeable batteries.

2.2 Putting DIADOS E into Operation

DIADOS E is either powered via a multi-range pow­er supply or from rechargeable batteries. The power supply automatically adapts to AC voltages be­tween 115 V and 230 V. If the voltage of your local power line is within this range, you can put DIADOS E into operation after connecting the pow­er supply. If the power supply is not connected at the time the device is turned on, DIADOS E will automatically be powered from the batteries. The batteries charge automatically whenever DIADOS E is connected to the power line.

2.3.1 Use with X-ray units

Two types of semiconductor detectors can be con­nected to DIADOS E: DIADOS diagnostic detector T60004 and DIADOS MAM detector T60005. Al­ways use the detector suitable for the radiation to measure.
The semiconductor detector is connected to the DETECTOR connector at the top of DIADOS E. DIADOS E can be on or off when the detector is connected. The detectors can be connected to the display unit via the 2 m detector cable directly and via a 6 m extension cable.
Press the ON/OFF key to turn DIADOS E on.
The ON/OFF key must be pressed for 2 s to turn the device off.
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NOTE
An extension cable used shall be connected between DIADOS E and the CT adapter (con­nection system W). The overall length of the detector cable with extension cable shall not exceed 20 meters.
Also refer to the user manual supplied with the CT chamber.
NOTE
When used with CT systems: In conjunction
with the multi-range power supply, power surges may inadvertently trigger the device (starting a measurement). This phenomenon does not occur when the device is exclusively powered from batteries. In CT applications (CT chamber and CT junction box) operate DIADOS E only on battery power to avoid inadvertent measure­ments.
WARNING
Electricity is a source of risk, particularly when the product is not in perfect operating condition or when it is operated inappropriately.
Patient Hazard! Shock Hazard!
Only qualified staff is authorized to open the CT adapter (electric shock hazard!). Never attempt to repair a defective CT adapter.

2.3.2 Use with CT units

Checking the high voltage of the CT adapter
For this application a CT chamber (TM30009, TM30017 or TM77336) with CT adapter (T16018) has to be used.
Connecting the CT chamber
The CT adapter is connected to the DETECTOR socket at the connection panel of the DIADOS E (refer to Figure 2); the CT chamber is connected to the CT adapter. For connecting the chamber, the DIADOS E may be switched on or off.
Push the TEST key at the adapter and hold it de­pressed. The LED should illuminate and go out within 2 s. If the LED does not light up or go out, the high voltage supply is defective and correct meas­urements cannot be performed. In this case the CT adapter should be returned to the manufacturer for repair.

2.4 Positioning DIADOS E

Position DIADOS E such that the control panel is within easy reach and that the display can be read off.
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2.5 Basic Settings (Setup Menu)

The unit, timer, contrast and auto power-off time are selected in the Setup menu. In addition, the respec­tive calibration data can be viewed in the Setup menu.
Calibration Data Menu In this menu you can view the calibration data for the applications.
The keys RESET + APPL. take you to the Setup menu (press RESET first and, holding it depressed, push APPL.).
With and (APPL. and MODE keys) you navigate within the Setup menu, with (RESET key) you access the sub-menu to make selections. To exit menus without saving the changes, press ESC (ALT key).
Figure 7: Setup menu 1/2
Figure 8: Setup menu 2/2
Unit You can choose among the units Gy, R and C. As soon as the DIADOS E is officially calibrated, the unit “R” can not be selected.
Timer For measurements in normal mode, the timer can be set to OFF, 20 s or 2 s. The timer function is inactive in pulsed mode.
Figure 9: Calibration data menu 1/4
Figure 10: Calibration data menu 2/4
Figure 11: Calibration data menu 3/4
Figure 12: Calibration data menu 3/4
The first overview lists the application, the calibra­tion date and the label s or u.
The label “s” means secured and designates a offi-
cially calibrated application. The label “u” means
unsecured and designates an not officially calibrat­ed application.
Use or to choose the application and press to display the rest of the data.
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aK
NOTE
For measurements where an official calibration is required, only the following measured quantities are allowed: Ka,
aK
, Ka∙l and
aK
l (refer to sec-
tion 8.5).
Figure 13: Calibration data menu, example for the
RAD application
Measuring Delay Time Set a time between 1 and 5 s. The measuring delay time is waited after an automatic recognizing of the signal end. Then the measurement is regarded as completed and will be finished. Times longer than 1 s are meaningful if radiation distances are bigger than 1 s to expect. The total dose can be measured for several radiation pulses with big distances by it.
The data shown in Figure 13 represent:
Application detector type and number Calibration point calibration factor unit Filter calibration factor Filter calibration factor
Display Menu During the test the display briefly shows all possible characters. The test can be interrupted by activation of any of the keys. After the test the submenu re­mains on the display.
The display contrast can be adjusted between 0 and 9. Press to confirm a selection.
Auto Off [min] Set the time for DIADOS E to switch off automati­cally when no controls are activated. The tens and ones must be set individually and confirmed with . Set the tens first. With ALT you exit the submenu without saving changes.

2.6 Modes of Operation

DIADOS E offers two modes of operation, the nor­mal mode and the pulsed mode, which are select-
ed via the MODE key. In the normal mode, the de­vice measures dose, dose rate and time and a timed measurement can be performed. In the pulsed mode, the device measures dose, dose per pulse and number of pulses.

2.7 Measuring Quantities

DIADOS E measures air kerma Ka (unit: Gy), air kerma rate uct (unit: [Gy*cm] or [R*cm]), air kerma length prod­uct rate (unit: [Gy*cm/s] or [R*cm/s]). The selection has to be done in the Unit setup menu. The electri­cal unit C for measurement of the current (unit: A) or of the charge (unit: C) is also selected in the setup menu.
(unit: Gy/s), air kerma length prod-
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When used with X-ray units for radiation qualities according to DIN EN 61267 (RQR 2 to RQR 10 and RQA 2 to RQA 10) in range 40 to 150 kV:
dose or dose rate during radiography and
fluoroscopy
exposure time or irradiation time dose per pulse and number of pulses
When used with mammography units for radiation qualities according to DIN EN 61267 (RQR-M 1 to RQR-M 4 and RQA-M 1 to RQA-M 4) as well as Mo-Anode 25 µm Rh (+ 2 mm Al), W-Anode 50 µm Rh (+ 2 mm Al) and Rh-Anode 25 µm Rh (+ 2 mm Al) W-Anode 50 µm Ag (+ 2 mm Al) W-Anode 0.7 mm Al (+ 2 mm Al), in range 25 to 45 kV:
dose or dose rate exposure time or irradiation time dose per pulse and number of pulses
When used at dental X-ray units in the range of 40 kV to 90 kV with filter 8.5 mm Al or 8.5 mm Al +
0.5 mm Cu:
dose or dose rate exposure time or irradiation time dose per pulse and number of pulses
When used with CT systems for radiation qualities according to DIN EN 61267 (RQT 8 to RQT 10) in range 100 to 150) kV:
dose length product or dose length product
rate
exposure time or irradiation time dose per pulse and number of pulses
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Low
Medium
High
MAM
0.15 µGy/s ... 120 µGy/s
0.02 mGy/s ... 12 mGy/s
2 mGy/s ... 1.3 Gy/s
DENT
0.1 µGy/s... 45 µGy/s
0.01 mGy/s ... 5 mGy/s
0.5 mGy/s ... 500 mGy/s
RAD
0.1 µGy/s... 45 µGy/s
0.01 mGy/s ... 5 mGy/s
0.5 mGy/s ... 500 mGy/s
CT
0.2 mGy*cm/s... 150 mGy*cm/s
0.02 Gy*cm/s... 17 Gy*cm/s
2 Gy*cm/s ... 1700 Gy*cm/s
Current
3 pA ... 2 nA
0.3 nA ... 200 nA
0.03 µA ... 20 µA
Low
Medium
High
MAM
0.15 µGy ... 1.2 Gy
20 µGy ... 120 Gy
2 mGy ... 13 kGy
DENT
0.1 µGy ... 450 mGy
10 µGy ... 50 Gy
0.5 mGy ... 5 kGy
RAD
0.1 µGy ... 450 mGy
10 µGy ... 50 Gy
0.5 mGy ... 5 kGy
CT
0.2 mGy*cm ... 1.5 kGy*cm
20 mGy*cm ... 170 kGy*cm
2 Gy*cm ... 17 MGy*cm
Charge
3 pC ... 20 µC
0.3 nC ... 2 mC
30 nC ... 200 mC

2.8 Measuring Ranges

The limits of the measuring range depend on the selected range (keys ALT + RANGE) and on the selected radiation (keys ALT + FILTER).

2.8.1 Range Limits for Dose Rate Measurement

Table 1: Range limits for dose rate measurement. Typical values for a minimum resolution of 1% in depend-
ence of the measuring range and of the application

2.8.2 Range Limits for Dose Measurement

Table 2: Range limits for dose measurement. Typical values for a minimum resolution of 1% in dependence of
the measuring range and of the application
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f
[Hz]
T
pulse
[ms]
Low
[nGy/pulse]
Medium
[µGy/pulse]
High
[µGy/pulse]
150
3.3 2
0.1 ... 1
9
5.5 4
0.12
0.07
0.07
11.0
6.0
3.5
100
5 3
0.1 ... 1
10
6
3.5
0.1
0.1
0.1
13
8 5
50
10
5
0.1 ... 3
15
7
3.5
0.2
0.2
0.2
24 13 10
25
20 10
0.1 ... 3
26 12
5
0.5
0.4
0.4
52 25 15
10
20 10
0.1 ... 1
26 10
5
1 1
0.5
50 50
5

2.8.3 Lower Range Limit for Dose per Pulse Measurement

Table 3 shows the lower range limits for dose per pulse measurements. If the measured value drops below the lower limit, DIADOS E will display LO instead of the measured value. Two asterisks "**" appearing next to a measuring value indicate an elevated measuring error due to insufficient resolution.
Table 3: Lower range limit for dose per pulse measurement. Typical values at a minimum resolution of 1% in
dependence of the measurement range. We assume that the pulse duration T
is shorter than the
pulse
interval between two pulses.
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2.9 Digital Resolution

The minimum digital resolution of the dose and dose rate readout within the measurement range limits shown in tables 1 and 2 is 1%. The display range for radiography and fluoroscopy time is (0.001 … 9999) s, in the LOW range (0.01 ...
9999) s.
The digital resolution for the charge and current readout is 30 fC and 30 fA, respectively.

2.10 Entering the Chamber Calibration Factor

If DIADOS E is not officially calibrated, the stored calibration data can be completed or corrected (e.g. for a new detector) by means of a command sent via the RS232 interface. To officially calibrate DIADOS E for specific applications, the device and all detectors to be used should be shipped to PTW Freiburg.
For information on the command, please refer to the separate interface manual „RS232 Interface for PTW-DIADOS E“ D616.131.01.
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Turn the device on
ON/OFF
Setup
RESET + APPL.
Selection of unit, timer, contrast and auto power-off data display
Connect detector
Socket
DETECTOR
DIADOS Diagnostic Detector T60004 for dental and conventional radiography DIADOS MAM Detector T60005 for mam­mography CT ion chamber TM30009, TM30017 or TM77336 each with adapter
Select application
APPL.
RAD DENT CT Mammography (MamM/M, MamM/R, MamW/A, MamW/R, MamR/R, MamWAg)
Select filter/calibration factor
ALT + FILTER
Unatt. Att.
Select operating mode
MODE
Normal mode with measurement of dose, dose rate and time or pulsed mode with measurement of dose, dose per pulse and pulse
Select measuring range
ALT + RANGE
LOW, MEDIUM, HIGH or Auto Range
Display changeover
ALT
In normal mode toggle between dose, dose rate and time or in pulsed mode toggle between dose, dose per pulse and pulse
Perform zero adjustment
ALT + ZERO
Measurement
AUTOSTART
or
START/STOP
Measurement begins when signal is de­tected
Manual start and stop

3 DIADOS E – Brief Operating Instructions

Allow the device to warm up before zeroing and before performing measurements.
Except for CT applications (dose length product unit), the detector should always be fully irradiated.
DIADOS E is permanently in the Autostart mode. This means that a measurement begins, as soon as a signal is detected.
The START/STOP key can be used to initiate a measurement manually.
While a measurement is in progress, the current dose/dose rate is indicated in intervals of 0.5 s. The ALT key can be pressed to toggle between the dif­ferent readouts during a measurement.
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1 2 3 4
5 6 7 8

4 Performing a Measurement

4.1 General Information for Measurements

After turning DIADOS E on, you will first see the PTW logo and the firmware version number; then the measurement display appears. All settings (set­up as well as the MODE, RANGE, APPL. and FILTER keys) of the last application are retained. Only the measuring values are reset to zero.

4.2 Dose, Dose Rate and Dose per Pulse Measurement

4.2.1 Preparing for a Measurement

For measurement of the dose, dose rate or dose per pulse, DIADOS E must be set to radiological units. If need change the unit selection in the Setup menu.
Select application and filter/calibration factor: keys APPL. and ALT + FILTER.
Select measuring range with RANGE: If the range changes automatically during the measurement, the readout changes to AUTO M or AUTO H.
Select operating mode with MODE.
Perform a zero adjustment (key ZERO, refer to chapter 1.5.4).
Figure 14: DIADOS E display for radiological
measurements
1 Resolution:
" " greater than 0.5 %, "*" greater than 1 %, "**" less than 1 %
2 Unit C, Gy or R; displayed in reverse video in
pulsed mode
3 Application:
RAD – convential radiology, DENT – dental application, CT – CT application or MamX/X – mammography (MamM/M, MamM/R, MamW/A, MamW/R, MamR/R, MamWAg)
4 Measuring range: Low, Med, High or Auto 5 Measuring value 6 Measurement status:
RDY – ready to take a measurement, RUN – measurement in progress, STA – measurement started with START/STOP, STP – measurement stopped with START/STOP, TST – measurement stopped by timer
7 Filter:
"Unatt." (without additional filtration) or "Att. " (with additional filtration)
8 Battery status: full/depleted
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NOTE
Check that the semiconductor detector suitable for the application is connected to DIADOS E and that the appropriate calibration factor has been selected with APPL and ALT+FILTER. Otherwise DIADOS E will not be able to display the correct values.
CAUTION
Improper handling.
Equipment damage!
Do not use tape with two adhesive sides be­cause the detector is difficult to remove. Keep the X-ray path clear of adhesive tape.

4.2.2 Positioning the Semiconductor Detectors

Position the semiconductor detector for the selected
application. If you have selected the “Unatt.”
FILTER setting, for instance, DIADOS E expects to measure the dose in front of the phantom. If you
have selected the “Att.” filter setting, however,
DIADOS E expects to measure the dose behind the phantom.

4.2.3 Starting the Measurement

Autostart:
DIADOS E is permanently in the Autostart mode. This means that a dose measurement begins, as soon as a signal is detected. Before, however, all measuring values will be set to zero.
Dose rate measurement with the timer function: The dose rate measurement begins 3 s after a dose rate signal is detected (see section 1.5.10).
Manual start:
A dose measurement and the corresponding time measurement can also be started with the START key.

4.2.4 Display during the Measurement

Using cassette adapter T20002
The detector is installed within the cassette adapter which, in turn, is inserted in the holder for the image receptor cassette (refer user manual of the detec­tor).
If a suitable adapter is not available, a Velcro tape can be used to install the detector in the X-ray path. The Velcro tape should be attached on the back of the detector for this purpose.
The display is updated at 0.5 s intervals.
Normal mode:
Depending on your selection, the dose, the dose rate or the measuring time will be displayed with the ALT key. With ALT you can toggle between the displayed parameters during and after the meas­urement.
Pulsed mode:
Depending on your selection, the dose, the dose per pulse or the number of pulses will be displayed with the ALT key. With ALT you can toggle between the displayed parameters during and after the measurement.
In the dose per pulse measurement, the device determines the dose while counting the pulses. The correct result will not be displayed before the end of the series of pulses. During the measurement the displayed values will be below the actual values, but they approach the actual value with increasing duration of the pulse series.
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NOTE
The displayed dose per pulse result is a value averaged over all pulses of the series. A change of the dose rate during the measurement, without a minimum pause of the measuring delay time, will cause erroneous readouts.
NOTE
If the selected fluoroscopy time is too short and the timer function is enabled, the following readouts may be displayed after the measure­ment:
both dose rate and measuring time are zero dose rate and measuring time, the measuring
time is shorter than the timer interval. The displayed measuring values blink (see sec­tion 1.5.10).

4.2.6 Display at End of Measurement

When the measurement is over, the following pa­rameters are displayed: dose and time or dose per pulse and number of pulses.
The dose rate indication depends on the measure­ment type: with or without timer.
If a pulse count error occurs due to a signal that is too small (see section 2.8.3) DIADOS E will display “LO” instead of the value.
Dose rate measurement:
During dose rate measurements, the dose rate is displayed at intervals of 0.5 s. If the timer is active, the measuring time will blink for a period of time equivalent to the timer setting plus 6 s. Afterwards, the measuring time will stop blinking.
Digital resolution:
If the resolution is insufficient, one or two asterisks (* or **) are displayed to the left of the measured value.
If the digital resolution is below 1 %, two asterisks ** are displayed. For resolutions between 0.5 % and 1 %, one asterisk * is displayed. When no asterisks are displayed, the digital resolution is better than
0.5 %.
Without timer: The displayed dose rate is zero.
With timer: After the measurement, the average dose rate and the timer interval (2 s/20 s) will be displayed. The mean dose rate is the average calculated over the last 2 s or 20 s of fluoroscopy; the last 3 s before the radiation switches off are ignored.

4.2.5 Ending the Measurement

A measurement initiated with Autostart ends auto­matically when no measuring signal is detected for more than the measuring delay time. It is not possi­ble to stop the measurement manually. RESET aborts a measurement and resets the measured values to zero. With START/STOP you abort an Autostart measurement and initiate a manual measurement.
A manually initiated measurement is stopped with START/STOP.
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4.3 Charge and Current Measurement

4.3.1 General Information

DIADOS E can also be used as an electrometer for measurement of current or charge. This is possible only when the unit C has been selected in the Set­up menu.
Please note that DIADOS E will almost exclusively measure currents and charges in the direction indi­cated as positive. A positive direction means that the current will flow from the amplifier. In the direc­tion indicated as negative, currents up to only ap­prox. -1 pA can be measured.

4.3.2 Preparing for a Measurement

Use the RANGE function to select the measuring range LOW, MEDIUM or HIGH. Table 1 section 2.8 shows the upper range limits for the ranges Low, Medium, and High in current measurements. The same limits apply for charge measurements (Table 2 section 2.8), because these are based on current measurements.
Besides the fixed ranges, the Autorange can also be selected with the RANGE function. The Au­torange is indicated by AUTO L in the line indicating the range.
Use the MODE key to select normal or pulsed mode. In normal mode, the device will measure the current, the charge and the time. In pulsed mode, the device will measure the charge, the charge per pulse and the number of pulses and the unit in the upper line is displayed in reverse video.
Please observe the information given in chapter 2. Connect the measuring cable to the DETECTOR socket at the top of DIADOS E (refer to Figure 2).
The display will be similar to the one shown in Fig­ure 15 (electrical unit in the first line, no indication of application and filter).
Figure 15: Display in electrometer mode
Now install the detector at the measuring point.

4.3.3 Starting the Measurement

DIADOS E is permanently in the Autostart mode. A measurement will begin as soon as a signal is de­tected. The measurement can also be started man­ually with the START/STOP key.
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4.3.4 Display during the Measurement

4.3.6 Display at End of Measurement

Normal mode:
Depending on your selection, the current, the charge or the measuring time will be displayed with the ALT key. With ALT you can toggle between the displayed parameters during and after the meas­urement.
Pulsed mode:
Depending on your selection, the charge, the charge per pulse or the number of pulses will be displayed with the ALT key. With ALT you can tog­gle between the displayed parameters during and after the measurement.
Digital resolution:
If the resolution is insufficient, one or two asterisks (* or **) are displayed to the left of the measured value. If the digital resolution of the display is below 1%, two asterisks ** will appear, with a resolution between 0.5% and 1% one asterisk * appears; if the digital resolution is greater than 0.5% no asterisks are displayed.
Normal mode:
After the measurement, you can toggle between the measured values with the ALT key. The current is given as 0.00 A.
Pulsed mode:
After the measurement, you can toggle between the measured values with the ALT key.

4.3.5 Ending the Measurement

A measurement initiated with Autostart ends auto­matically when no measuring signal is detected for more than the measuring delay time.
A manually initiated measurement is stopped with START/STOP.
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NOTE
A measurement cannot be performed with the Autostart function of DIADOS E when the detec­tor is located in one of the peripheral bore holes of the CT phantom. In this case a measurement must be started with the START/STOP key. A measurement can be performed with the Auto­start function when the detector is located in the central bore hole.

4.4 Measurements in Computed Tomography

Connect the CT chamber according to section 2.3.2 and check the high voltage of the CT adapter. Posi­tion the CT chamber for the selected application.
The device is operated as described in the previous sections. The following difference, however, should be observed: Instead of the parameters dose and dose rate, the device will determine the parameters dose-length product and dose-length product rate (unit R or Gy).
Settings at DIADOS E
Use the APPL. key to select the application CT. Use the MODE and the ALT + FILTER keys to se­lect the operating mode and the necessary filter setting. Typical settings: RQT9 0.25 mm Cu for measurements free in air and for measurements in phantoms. The LOW range is suitable for most measurements.
Zero adjustment
Perform a zero adjustment. Please note that after application of high voltage to the chamber the po­tentials in the chamber may take a few minutes to stabilize.
Measurement
Perform the measurement as described in sec­tion 4.2 and perform an air density correction of the reading.
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CAUTION
Improper handling.
Equipment damage!
Do not use tape with two adhesive sides be­cause the detector is difficult to remove. Keep the X-ray path clear of adhesive tape.

4.5 Measurement at Dental X-ray Units

For measurement of the image receptor dose KB at intraoral, remote and panorama X-ray units, DIADOS E must be set to radiological units (Setup menu).
Additionally, an absorber according to DIN 6868-51 (PTW absorber T42018 or T42029) must be in­stalled between the focus and the detector and the correct radiation quality must be selected with the FILTER key at the DIADOS E (see section 1.5.6).
Performing a measurement
The desired dental qualities must be selected with the keys ALT + FILTER. For filtration with
2.5 mm Al (RAD application) and 8.5 mm Al, the
calibration factors for a tube voltage of 70 kV are stored in the DIADOS E; you will find the correction factors kq for 50 and 90 kV in the calibration certifi­cate of the respective detector (refer also to user manual of the detectors D860.131.00).
4.5.1 Measurement at Intraoral and Remote X­ray Units
Positioning the semiconductor detector
Position the detector in the image receptor plane of the X-ray unit such that the active field of the detec­tor is fully irradiated while the radiograph is taken; a square on the detector housing marks the active field.
You can install the detector in the X-ray path, using Velcro tape. The Velcro tape should be attached on the back of the detector for this purpose.
Use the MODE key to set the DIADOS E to normal mode.
DIADOS E is permanently in the Autostart mode. This means that a dose measurement begins, as soon as a signal is detected.
Perform a zero adjustment.
Initiate a radiograph at the X-ray unit; after the ex­posure, you can toggle between the image receptor dose KB and the duration of the measurement with the ALT key.
To perform a new measurement, simply initiate another radiograph; this will automatically delete the previous parameter readout (Autoreset).
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CAUTION
Improper handling.
Equipment damage!
Do not use tape with two adhesive sides be­cause the detector is difficult to remove. Keep the X-ray path clear of adhesive tape.
CAUTION
Improper handling.
Equipment damage!
Ensure that the cable is routed so as not to im­pede the range of motion of the X-ray unit and of the cassette adapter.
Position the attenuator such that it covers the semiconductor detector in its entirety while the radiograph is taken.
WARNING
Improper handling.
Patient Hazard!
A measurement performed in the Autostart mode at panorama X-ray units will not yield correct dose values, because a detector signal caused by scattered radiation may cause the parameter readout to autoreset even after the detector has passed through the X-ray. A dose measurement should always be performed with the START/STOP key.

4.5.2 Measurements at Panorama X-ray Units

Positioning the semiconductor detector
For dose measurement at panorama X-ray units with a moving image receptor cassette, the semi­conductor detector as well as a cassette adapter is used. The cassette adapter replaces the image receptor cassette (Refer to the user manual of the detector).
The detector is connected to the DIADOS E via extension cable.
If it is not possible to use the cassette adapter (e.g. due to its size) you can install the detector in the X­ray path, using Velcro tape. The Velcro tape should be attached on the back of the detector for this pur­pose.
Performing a measurement
Perform a zero adjustment.
For a dose measurement, the Autostart mode must first of all be disabled with the START key. After activation of the START key, DIADOS E will begin measuring the time and dose, and a panoramic radiograph can be initiated.
Assemble the absorber demanded by DIN 6868-51 (PTW absorber T42018 or T42029) and attach it to the secondary diaphragm, using adhesive tape (also refer to section 4.2.2). Keep the adhesive tape away from the X-ray path.
Select the appropriate radiation quality with the FILTER key at the DIADOS E (see section 1.5.6).
When the radiograph has been taken DIADOS E will indicate the image receptor dose KB measured by the detector; the displayed measuring time is irrelevant.
The next measurement can be performed by push­ing the START/STOP key and initiating a new pan­oramic radiograph.
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Message
Cause
Remedy
REPEAT
Overranging of the electronic measuring system in dose measurements and Au­torange mode. See section 1.5.8.
Repeat measurement.
OL
The electronic measuring system is out of range. A negative overload condi­tion is indicated by –OL.
Select another measuring range with RANGE.
LO
The lower range limit was exceeded in the dose/pulse mode.
Choose a more sensitive range and repeat the meas­urement.
EEPROM defect
Defect of the internal memory.
The device cannot be used any more. Please contact Customer Service. After 5 s DIADOS E will switch off.
Electrical calibration factors corrupted!
Electrical calibration prob­lem.
The device cannot be used any more. Please contact Customer Service. After 5 s DIADOS E will switch off.
Setup corrupted!
RESET = continue with default values
Erroneous device settings, problem is not severe.
Confirm message with RESET and continue. Values for range, mode, filter, etc. are reset to the defaults.
Radiological calibration factors corrupted RESET = set defaults
The radiological calibration for one of the applications is erroneous.
Confirm the message with RESET. This will set the calibration factors of the application in question to
0.000. Download the calibration factors via the sys­tem’s interface („User Manual RS232 Interface for PTW-DIADOS E“ D616.131.01).
Radiological calibration factors corrupted
The radiological calibration for one of the calibrated ap­plications is erroneous.
The device cannot be used any more. Please contact Customer Service. After 5 s DIADOS E will switch off.
Data Error press RESET
The processor is not func­tioning correctly.
Press RESET and repeat the measurement.
Zero failed press RESET
Due to an excessive zero signal, the system could not be zeroed.
Make sure that the connected detector is not irradiated and does not move while the system is being zeroed. See section 1.5.4.

5 Error Messages and Troubleshooting

5.1 Equipment Error Messages

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Problem
Cause
Remedy
No keypad response.
Keypad locked via interface.
Unlock keypad via interface. Refer to interface description („User Manual RS232 Interface for PTW-DIADOS E“).
LCD does not illumi­nate.
The rechargeable batteries are depleted.
Connect the multi-range power supply. The bat­teries charge as soon as the power supply is con­nected.
The calibration data of the application cannot be displayed.
The device is not calibrated for the application.
Download the calibration factors of the appropri­ate detector via the interface („User Manual RS232 Interface for PTW-DIADOS E“).

5.2 Problems during Operation

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Device designation
PTW-DIADOS E, type 11035
Manufacturer
PTW-Freiburg
Type-approval certificate in Germany
as: Diagnostic dosemeter by: German National Metrology Institute (Physikalisch- Technischen Bundesanstalt, PTB) in Braunschweig according to: § 13 of the German Verification Act (Eichgesetz) of March 23, 1992, (BGBl. I S. 711) in the presently relevant version
approval sign:
23.04
03.01
issued to: PTW-Freiburg
Use
Diagnostic dosemeter acc. to IEC 61674 for dose and dose rate measurement in diagnostic X-ray applications, for measurement of the dose length product and the dose length product rate in CT applications, electrometer for current and charge measurement
Measuring mode
continuous operation
Pollution degree
II
Overvoltage category
II
Protection class
II
Electrical safety class
IEC61010-1
Electromagnetic compatibility
suitable for operation in a basic electromagnetic environment according to IEC 61326-1
Influence of electromagnetic disturbances
  5% of the beginning of the measuring range acc. to IEC 61674

Technical Manual

6 Technical Specifications

Only values with specified tolerances or limits are guaranteed. Values without tolerances are for information only.
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Device designation
PTW-DIADOS E, type 11035
Measuring quantities and units
air kerma in [Gy], air kerma rate in [Gy/s], exposure in [R], exposure rate in [R/s], irradiation time in [s], current in [A], charge in [C] dose per pulse in [Gy/pulse] or [R/pulse] number of pulses
with optional CT adapter: air kerma length product in [Gy*cm] or [R*cm], air kerma length product rate in [Gy*cm/s] or [R*cm/s]
Display range for irradiation time
(0.001 ... 9999) s in the ranges Medium and High (0.01 ... 9999) s in the range Low
Digital resolution
DIADOS E electrometer: 30 fA or 30 fC DIADOS Diagnostic Detector T60004: 1 nGy/s or 1 nGy DIADOS MAM Detector T60005: 2 nGy/s or 2 nGy
Leakage current (zero drift)
 30 fA
Settling time
1 s in the ranges Medium and High 3 s in the range Low
Reproducibility (standard deviation)
 0.5 %
Energy dependence in each nominal useful range
 5 %
Linearity
 2 %
Dose rate dependence
 2 %
Effect of radiation incidence ( 5)
 3 %
Power supply
4 rechargeable NiMH batteries, size AA (L389028)
operating time with one set of batteries (2600 mAh): approx. 30 hours
charging time: 23 hours or multi-range power supply (L991047)
(115 … 230) V ± 15 %; (50 … 60) Hz, 9 VDC 10 W,
external via jack plug, 9 VDC ± 10 %, max. 500 mA
Stabilization time
30 s
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Device designation
PTW-DIADOS E, type 11035
Rated range of use Temperature Relative humidity Atmospheric pressure Maximum operating altitude
(10 ... 40) C (10 ... 80) C rel. humidity; 20 g/m³ max. (700 ... 1060) hPa 3000 m above sea level
Environmental conditions for transport and storage Temperature Relative humidity Atmospheric pressure
(-20 ... 60) C (10 ... 85) C rel. humidity (600 ... 1200) hPa
Dimensions
100 mm x 44 mm x 200 mm incl. socket
Weight
500 g incl. batteries
The product fulfills the following requirements of EN55011 / IEC/CISPR11.
Emissions test
Compliance
Electromagnetic environment –
guidance
RF emissions IEC/CISPR 11
Group 1
The product uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in near­by electronic equipment.
RF emissions IEC/CISPR 11
Class B
The product is suitable for use in all establishments, including domestic establishments and those direct­ly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
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WARNING
Improper execution of service tasks.
Hazards to Persons! Equipment Damage!
The following service tasks must only be per­formed by specially trained staff.
Further service tasks may only be carried out by PTW-Freiburg or by persons authorized by PTW-Freiburg.
WARNING
Liquids have entered the device.
Shock Hazard, Erroneous Measurement!
The device must be thoroughly inspected by service personnel before being used again.
CAUTION
Disinfection of the surface with disinfectants on a phenol base or peroxide compounds.
Equipment Damage!
Do not use disinfectants on a phenol base or peroxide compounds to disinfect the surface.

Service Manual

7 Cleaning

Device surface
Before cleaning or disinfecting the device sur-
face, disconnect the device from the power line.
Wipe the device clean with a moist cloth. Do not
let liquid enter the device. Do not apply spray to the device.
Use a mild soap solution to clean the device.
Due to the device geometry, a thorough disinfec­tion is not possible. The device cannot be steri­lized.
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Cables

8.3 Safety Inspections

Disconnect the cables from the devices (always
pull on the connectors, not on the cables!).
Clean the cable by rubbing it down with a cloth
moistened with soap water or disinfectant.
Do not immerse the cable in liquids!

8 Maintenance

In the following you will find a list of the mainte­nance measures and inspections necessary for the product.

8.1 Checks before each use

Before each use, visually inspect the device and
cables for signs of mechanical damage.
Also check the display as outlined in section 2.5.
If you detect signs of damage or functional prob­lems, have the device repaired before putting it into service again.

8.2 Repair

Repairs may only be carried out by PTW-Freiburg or by persons / companies authorized by PTW-Freiburg.
Only regularly inspected products are fail-safe. To preserve the functional security and operational safety, a safety inspection is to be executed at regular intervals according to national regulations.
These inspections must only be performed by inde­pendent persons with adequate training and experi­ence.
It is recommended to execute the safety inspections every 2 years.

8.4 Technical Inspections of the Measuring System

The product must be inspected at regular intervals according to national regulations. It is recommend­ed to perform technical inspections of the measur­ing system every 5 years at PTW-Freiburg or a qualified calibration laboratory.
Inspections must also be performed after repairs or after each influence which may have changed the behavior of the product.
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DANGER
Improper handling of batteries.
Explosion Hazard!
Do not throw the rechargeable batteries into a fire.
WARNING
Improper handling of batteries.
Bodily injury!
If electrolyte leaks from the battery, avoid contact with skin or clothes. Immediately clean skin or clothes that have come in contact with electrolyte with water. In case of eye contact, immediately rinse eyes with water and consult doctor.
Do not open rechargeable batteries.
WARNING
Improper handling of batteries.
Risk of Fire or Skin Burns!
Never short the rechargeable batteries together.
WARNING
Improper handling of batteries.
Bodily injury! Equipment damage!
Equipment damage - Do not open rechargeable batteries. Never expose rechargeable batteries to water. Store and use the rechargeable batter­ies at the ambient conditions (temperature, rela­tive humidity) specified for the device.

8.5 Maintenance of Officially Calibrated Dosemeters

This paragraph concerns DIADOS E users in countries where an official calibration is re­quired, e.g. Germany.
In case of officially calibrated dosemeters, the user is not allowed to open the instrument and to per­form manipulations that may change the measuring value. Therefore the housing is sealed with official stickers. If one or more of these stickers are violat­ed, then the official calibration is not longer valid.
If a dosemeter is not working correctly, then it may be sent for repair to a service station that is ap­proved by the authorities. After repair the doseme­ter must be officially calibrated again. However, it may be used until this new official calibration can be done.

8.7 Rechargeable Batteries

If the repair has been performed by a non-approved service station, then the dosemeter may only be used for applications that are under the official cali­bration procedure if it has been officially re­calibrated.

8.6 Calibration

When using not officially calibrated dosemeters, we recommend having the system calibrated every 2 years at PTW-Freiburg or by specially trained staff on site.
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NOTE
For the rechargeable batteries to keep their full capacity, they should be fully discharged and then recharged again approximately every 3 months.
CAUTION
Improper handling of batteries.
Equipment damage!
Do not operate the DIADOS E with disposable batteries. Use only the special rechargeable NiMH batteries.
NOTE
New rechargeable batteries will reach their full capacity only after several charging and dis­charging cycles.
Charging
The batteries recharge whenever DIADOS E is connected to the power line. The batteries take about 23 hours to recharge. Overcharging is impos­sible.
The batteries have a service life of approx. 1 year. If a set of recharged batteries does not provide power for the full operating time of approx. 30 hours, the batteries must be replaced.
Replacing the batteries
Insert 4 new NiMH batteries. Observe the bat-
tery polarity! Use only AA size NiMH batteries (refer to section 6 Technical Specifications).
Close the battery compartment.
Follow these steps to replace the NiMH batteries:
Turn off DIADOS E.
Disconnect DIADOS E from the power line.
Remove the lid from the battery compartment on
the rear of the device and remove the NiMH bat­teries.
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9 Disposal of the Product

At the end of the product life, the components of the DIADOS E must be disposed of in compliance with the applicable waste control regulations.
The different materials must be separated and re­cycled as appropriate.
DIADOS E does not contain hazardous materials.
The electronic components must be recycled ac­cording to local regulations.
The rechargeable NiMH batteries must be disposed of in compliance with the applicable regulations.
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Literature

[1] Council Directive 93/42/EEC concerning medical devices
(Medical Device Directive - MDD)
[2] Council Directive 97/43/EURATOM on health protection of
individuals against the dangers of ionizing radiation in rela­tion to medical exposure
[3] IEC 61267
Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of charac­teristics
[4] IEC 61326-1
Electrical equipment for measurement, control and laborato­ry use - EMC requirements – Part 1: General requirements
[5] IEC 61674 Medical electrical equipment -
Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging
[6] IEC 61010-1
Safety requirements for electrical equipment for measure­ment, control and laboratory use; Part 1: General requirement
[7] IEC 60950-1
Information technology equipment - Safety Part 1: General requirements
[8] DIN 6868-51
Image quality assurance in X-ray diagnostics - Acceptance testing of dental radiographic equipment; Rules for the inspection of image quality after installation, mainte­nance and modification
[9] IEC 61140
Protection against electric shock - Common aspects for installation and equipment
[10] EN 55011 (IEC/CISPR 11)
Industrial, scientific and medical equipment - Radio­frequency disturbance characteristics - Limits and methods of measurement
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This symbol indicates the product contains hazardous materials in excess of the limits estab­lished by the Chinese standard SJ/T11363-2006 Requirements for Concentration Limits for Cer- tain Hazardous Substances in Electronic Information Products. The number in the symbol is the Environment-friendly Use Period (EFUP), which indicates the period during which the toxic or hazardous substances or elements contained in electronic information products will not leak or mutate under normal operating conditions so that the use of such electronic information products will not result in any severe environmental pollution, any bodily injury or damage to any assets. The unit of the period is “Year”.
In order to maintain the declared EFUP, the product shall be operated normally according to the instructions and environmental conditions as defined in the product manual, and periodic mainte­nance schedules specified in Product Maintenance Procedures shall be followed strictly.
Consumables or certain parts may have their own label with an EFUP value less than the prod­uct. Periodic replacement of those consumables or parts to maintain the declared EFUP shall be done in accordance with the Product Maintenance Procedures.
This product must not be disposed of as unsorted municipal waste, and must be collected sepa­rately and handled properly after decommissioning.
该标识表明本产品含有的有毒有害物质超出SJ/T11363­2006标准规定的《电子信息产品中有毒有害物质的限量要求》。标识中的数字为本产品的环保使
用期限(EFUP),表明在正常使用的条件下,电子信息产品内含的有毒有害物质或元素不会发生 外泄或突变,用户使用该电子信息产品不会对环境造成任何严重污染或对人身、财产造成任何严重 损害的期限。单位为年。
为保证所声明的环保使用期限,应按产品手册中所规定的指示和环境条件进行正常使用,并严格遵 守产品维护程序中规定的定期维护和保养日程。
产品中的耗件或某些零部件可能具有单独的标识,其环保使用期限有可能短于产品本身的环保使用 期限。应按产品维护程序定期更换这些耗件或零部件,以保证所声明的整个产品的环保使用期限。
本产品在使用寿命结束后不可作为普通生活垃圾处理,必须另行收集并作妥善处理。

Appendix A: China Electronic Industry Standard Compliance

附录:中华人民共和国电子产业标准
This Supplement concerns China Electronic Industry Standard Compliance
此附录涉及中华人民共和国电子产业标准的相关规定
The following product pollution control information is provided according to SJ/T11364-2006 Marking for Control of Pollution caused by Electronic Information Products.
根据SJ/T11364-2006标准规定的《电子信息产品污染控制标识要求》特提供以下有关产品污染控制方面的信息。
1. Explanation of Pollution Control Label
污染控制标识说明
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Component Name
部件名称
Hazardous substances’ name
有毒有害物质的名称
(Pb)
(铅)
(Hg)
(汞)
(Cd)
(镉)
(Cr(VI))
(六价铬)
(PBB)
(多溴联苯)
(PBDE)
(多溴二苯醚)
Display 显示设备
X X X X X
X
Others 其它
X O X X X
X
O: Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part
is below the limit requirement in SJ/T11363-2006.
X: Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials
used for this part is above the limit requirement in SJ/T11363-2006
Data listed in the table represents best information available at the time of publication. This table shows where these substances may be found in the supply chain of PTW electronic information
products, as of the date of sale of the enclosed product. Note that some of the component types listed above may or may not be a part of the enclosed product.
O: 表示该有毒有害物质在该部件所有均质材料中的含量均在SJ/T11363-2006 标准规定的限量要求以下。 X: 表示该有毒有害物质至少在该部件的某一均质材料中的含量超出SJ/T11363-2006 标准规定的限量要求。
此表所列数据为直至发布时所能获得的最全面信息。此表表明自本产品销售之日起在PTW电子信息产品的供应链上何处可能找到以上所述有毒有害物质。请注
意,以上所列的部件类型中的一些可能不属于本产品。
2. Name and Concentration of Hazardous Substances 有毒有害物质的名称及含量
Table 1 - Hazardous substances’ name and concentration.
1 - 有毒有害物质的名称及含量
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Index

A
ALT ............................................................................... 17
Appendix ....................................................................... 49
APPL. ............................................................................ 15
Application range .......................................................... 15
Auto off .......................................................................... 23
B
Measurement at dental X-ray units ................................ 35
Measurement, start/stop ................................................ 14
Measurements at panorama X-ray units ........................ 36
Measurements in Computed Tomography ............... 21, 34
Measuring Delay Time ................................................... 23
Measuring modalities ..................................................... 23
Measuring quantities ...................................................... 23
Measuring range ............................................................ 16
Measuring range limits ................................................... 25
MODE ............................................................................ 16
Basic settings ................................................................ 22
Batteries ........................................................................ 45
Brief operating instructions ............................................ 28
C
Calibration ..................................................................... 45
Calibration data ............................................................. 22
Calibration factors ......................................................... 15
Chamber calibration factor ............................................ 27
Charge and current, measurement ............................... 32
Cleaning ........................................................................ 43
Connectors .................................................................... 12
D
Detector, connection of ................................................. 20
Device, description ........................................................ 11
Display .................................................................... 12, 23
Disposal ........................................................................ 47
Dose, dose rate or dose/pulse measurement................ 29
E
Error messages ............................................................. 37
F
Features ........................................................................ 11
FILTER .......................................................................... 15
G
General information ......................................................... 2
I
Illustrations ...................................................................... 5
Inserting the Rechargeable Batteries ............................ 19
Intended use ................................................................... 6
K
Keypad .......................................................................... 13
L
Literature ....................................................................... 48
M
N
Normal mode ................................................................. 16
O
Officially calibrated dosemeters ..................................... 45
ON/OFF ......................................................................... 14
Operating mode, change ............................................... 16
P
Positioning ..................................................................... 21
Power ON/OFF .............................................................. 14
Problems during operation ............................................. 38
Pulsed mode .................................................................. 16
Putting into operation ..................................................... 19
R
RANGE .......................................................................... 16
Repair ............................................................................ 44
RESET ........................................................................... 14
Resolution, digital .......................................................... 27
S
Safety information ............................................................ 6
Safety inspections.......................................................... 44
Setup ............................................................................. 22
START/STOP ................................................................ 14
T
Technical inspections of the measuring system ............ 44
Technical specifications ................................................. 39
Timer ............................................................................. 22
TIMER function .............................................................. 17
Troubleshooting ............................................................. 37
U
Unit ................................................................................ 22
Z
ZERO ............................................................................. 14
Zero adjustment ............................................................. 14
Maintenance .................................................................. 44
Measurement ................................................................ 29
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