Page 1
User Manual
DIAMENTOR E2
T11033
from SN 02000 and higher
D651.131.00/05 en 2012-11 Gü/Hn/Kau
Page 2
General Information
DIAMENTOR E2
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 I of this directive. The product is a class IIb device
(MDD).
− Furthermore, the DIAMENTOR E2 helps fulfill
the requirements of the EC patient directive
97/43/EURATOM regarding the acquisition and
documentation of the radiation exposure of patients during X-ray examinations.
− Product standard
The product fully complies with the requirements of the following standards:
IEC 60580
− Electrical safety
The product fully complies with the requirements of the following standards:
IEC 60601-1
ANSI/AAMI ES 60601-1 /
CAN/CSA-C22.2.No.60601-1
− Electromagnetic immunity
The product fully complies with the requirements of the following standards:
IEC 60601-1-2
IEC/CISPR 11 class B
− The user manual is an integral part of the prod-
uct. 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
PTW-Freiburg or by persons authorized by
PTW-Freiburg, 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.
− This manual is in conformity with the product
specifications and all applicable safety standards valid at printing date. All rights are reserved for devices, circuits, techniques, software and names referred to in the manual.
− PTW-Freiburg reserves the right to make modi-
fications.
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.
2
D651.131.00/05 en
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DIAMENTOR E2
General Information
− PTW-Freiburg works in strict accordance with a
quality management system which is continuously updated according to national and international standards.
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
D651.131.00/05 en 3
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DIAMENTOR E2
Table of Contens
Table of Contents
1 INTENDED USE 5
2 FOR YOUR SAFETY 5
3 OPERATING CONTROLS AND INDICATORS 11
4 FIRST TIME OPERATION 12
4.1 Setting up the DIAMENTOR E2 12
4.2 Connecting the Supply Voltage 12
4.3 Connecting the Chamber and Printer and Putting into Operation 15
4.4 Mounting the ionization chamber 15
4.5 Basic Device Settings (Setup Menu) 16
5 PERFORMING A MEASUREMENT 17
5.1 Constancy Check 17
5.2 Measurement 17
5.3 Air Density Correction 18
5.4 Print out 18
6 ERROR MESSAGES AND TROUBLESHOOTING 19
7 CALIBRATION 20
8 PERIPHERALS 22
8.1 Printer 22
8.2 PC 22
9 CLEANING, PREVENTIVE MAINTENANCE AND DISPOSAL
9.1 Cleaning 23
9.2 Preventive Maintenance 23
9.3 Disposal of the Product 24
10 TECHNICAL SPECIFICATIONS
23
25
11 ACCESSORIES AND SPARE PARTS 27
12 SPECIAL ADJUSTMENTS 27
13 ELECTROMAGNETIC COMPATIBILITY (EMC) ACCORDING TO IEC 60601-1-2 28
APPENDIX: CHINA ELECTRONIC INDUSTRY STANDARD COMPLIANCE 32
LITERATURE 34
INDEX 35
4
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DIAMENTOR E2
Intended Use
1 Intended Use
The DIAMENTOR E2 is a device for measurement
of the dose area product and the dose area product
rate in diagnostic radiology. It fulfills the requirements of IEC 60580.
The dose area product is measured with an ionization chamber mounted directly to the light beam
diaphragm housing.
The DIAMENTOR E2 is a single channel microprocessor-controlled measuring system.
The DIAMENTOR E2 is equipped with a serial connector (socket SERIAL) to connect a label printer or
a PC.
This manual only describes the DIAMENTOR E2.
A detailed description of the RS232 interface is
supplied on request (document number
D651.131.1).
2 For Your Safety
The following safety statements are divided into
DANGER, WARNING, CAUTION and NOTE.
Definitions
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
could result in death or serious injury.
CAUTION
indicates a potential hazard. If not avoided, this
hazard could result in minor personal injury or
product/property damage.
NOTE
Provides useful information to assure that you
get the most from your equipment.
D651.131.00/05 en 5
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DIAMENTOR E2
For Your Safety
Safety Information
DANGER
Explosion Hazard – The product is not de-
signed for use in areas of medical locations
where an explosion hazard may occur. An explosion hazard may result from the use of
flammable anesthetics, skin cleansing agents
and disinfectants. Furthermore, the product is
suitable for use in an oxygen-enriched atmosphere only with certain restrictions. The atmosphere is oxygen-enriched when the room air
contains more than 25 % oxygen or nitrous
oxide.
WARNING
Shock Hazard – Strictly observe the following
warnings. Failure to do so may endanger the
lives of the patient, the user and other persons
involved.
− The product is a system device of
IEC 60601-1 protection class II in
combination with functional earth. It may be
put into operation only when connected to a
properly installed power outlet with earthing
contact.
− The installation of the product may only be
performed by trained electro-technical staff.
− Before using the product, the user must as-
certain that it is in correct working order and
operating condition.
− Inspect the connection cables for damage
before use. Replace damaged cables and
connectors immediately.
− When disconnecting the device from the
power line, first remove the connector from
the wall outlet. Then disconnect the cable
from the device.
− Liquids must not enter neither the display
unit nor the adapter. If liquids have entered
the product, it must be thoroughly inspected
before being used again.
− Extension cords must not be used.
Operation in the patient environment:
With all peripheral devices connected, the
product represents a medical system. The
product may be operated in the patient environment only if
− no peripheral devices are connected to the
serial interface or
− the peripheral devices connected meet the
requirements IEC 60601-1/
ANSI/AAMI ES 60601-1 /
CAN/CSA-C22.2.No.60601-1
− the peripheral devices connected meet the
requirements IEC 60950-1 / UL 60950-1 and
are operated outside the patient environment.
Exclusion of operation as device with patient contact:
− The device is not 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 connec-
tors of the device at the same time.
Exclusion of operation as a controlling instrument:
− The device is only for use to measure the
dose within radiation field. The product must
not be used to control radiodiagnostic
equipment or radiotherapy units.
− Devices on which moisture condensation
has developed as a result of temperature
changes must not be switched on unless
completely dry.
6
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DIAMENTOR E2
For Your Safety
WARNING
Shock Hazard – Strictly observe the following
warnings. Failure to do so may endanger the
lives of the patient, the user and other persons
involved.
Use of peripheral devices:
− Peripheral devices (PC, printer) may only be
connected if they meet the requirements of
IEC 60950-1 / UL 60950-1 or of standard
IEC 60601-1 ANSI/AAMI ES 60601-1 /
CAN/CSA-C22.2.No.60601-1.
These devices may only be operated in the
patient environment, if it is guaranteed that
they meet the requirements of IEC 60601-1/
ANSI/AAMI ES 60601-1 /
CAN/CSA-C22.2.No.60601-1.
− 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 in-
formation 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 standards IEC 60601-1/
ANSI/AAMI ES 60601-1 /
CAN/CSA-C22.2.No.60601-1.
WARNING
Suffocation Hazard – Dispose of the packag-
ing material, observing the applicable wastecontrol regulations. Keep the packaging mate-
rial out of children's reach.
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.
Risk of Poisoning – Chemicals required for
application or maintenance of the device, for instance, must under all circumstances be stored,
prepared, and kept at hand in their specific containers. Failure to observe this instruction may
result in severe consequences for the patient.
WARNING
Equipment failure - Electromagnetic fields are
capable of interfering with the proper performance of the device.
− The DIAMENTOR E2 should not be used in
the immediate vicinity of or placed on top of
or below other equipment. However, if the
application requires an arrangement of devices as described above, the
DIAMENTOR E2 should be watched to ensure its proper functioning in the specific arrangement.
− The customer or user of the
DIAMENTOR E2 should assure that it is
used in an electromagnetic environment as
described in IEC 60601-1-2.
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DIAMENTOR E2
For Your Safety
WARNING
Bodily Injury! Equipment Damage!
Modifications, additions or maintenance of the
equipment may be conducted only by suitably
qualified and trained persons.
Spare parts must be approved by the manufacturer.
After any modifications of the equipment, appropriate inspections and tests have to be carried out.
Failure to comply may lead to fatal or serious
personal injury and / or damage to the equipment, as well as void the warranty.
WARNING
The system has no means of isolation from the
supply voltage. When the mains plug is connected to the power line or the cable is clamped
into the DC supply, the system is powered,
even if the DIAMENTOR E2 is turned off.
CAUTION
Equipment damage - Handle the product with
care to avoid equipment damage.
Verify that the power ratings indicated on the
device are the same as those of your power
supply system.
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".
The ambient conditions specified in the "Technical Specifications" section must be ensured at
all times.
CAUTION
Equipment damage - If you move the X-ray
unit do not bump into doorframes or walls to
avoid damage to the DIAMENTOR E2.
8
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DIAMENTOR E2
For Your Safety
NOTE
Please observe the user manuals of all connected system components!
NOTE
Set up the device so that the operator has a
clear, unobstructed view of the control panel.
NOTE
Do not position the device so that it is difficult to
operate the disconnecting device.
Symbols on Product and Nameplate
Symbol Description
Observe the user manual.
Please refer to user manual.
The product bears the CE-mark.
The product is certified by VDE
(German Association for Electrical,
Electronic and Information Technologies)..
The product is certified by UL (Underwriters Laboratories) for both
the U.S. and Canadian markets, to
the applicable U.S. and Canadian
standards.
Figure 1: Definition of patient environment
The device is only suitable for use
with direct current.
Manufacturer and date of manufacture
Reference number
Serial number
Separate collection for electrical
and electronic equipment!
(refer also to 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 Appendix)
The connection of the DIAMENTOR E2 to the
ground wire does not have any protection function here, this serves as function earth.
D651.131.00/05 en 9
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DIAMENTOR E2
For Your Safety
Information for Installation
Inside the patient Outside the patient Not medical used area
environment environment
Power
supply unit
T99052
Power
limiter
T26060
or
Printer / PC
DIAMENTOR E2
PTW
T11033
IEC 60950-1
or
Figure 2: Note for installation in the patient environment
Printer / PC
IEC 60950-1
10
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DIAMENTOR E2
Operating Controls and Indicators
3 Operating Controls and Indicators
Figure 3: DIAMENTOR E2
1 Socket SERIAL for connection of label printer or PC (RS232 interface; RJ12 Western Plug)
2 Folding stand
3 Connection ionization chamber (connecting system A )
4 Connection adapter
5 On/Off switch Device switched on
Device switched off
6 Display (8 digit seven-segment display)
→
7 TEST (
8 PRINT (
menu mode. If the print mode is set to ”Prn off” the print function is inactive.
9 RESET (
mode
D651.131.00/05 en 11
) button to conduct a device test and for cursor control in the menu mode
↑
) button to print out the measured value on a connected printer and for cursor control in the
↵
) button to reset the reading to zero and to confirm settings and quit a menu in the menu
Page 12
4 First Time Operation
DIAMENTOR E2
First Time Operation
4.1 Setting up the DIAMENTOR E2
The DIAMENTOR E2 can be set up by means of
the folding stand on the back of the device.
Alternatively, the device can be fixed to the wall or a
plain surface by means of the velcro type ribbon
supplied with the DIAMENTOR E2. To do so, fasten
the self-adhesive back of the ribbon to the back of
the DIAMENTOR E2 and the opposite ribbon to the
wall or surface.
4.2 Connecting the Supply Voltage
WARNING
The DIAMENTOR E2 must only be connected
to one of the two ways described below.
Use only the listed original cable from PTW.
Observe the installation notes of the supply
voltage.
WARNING
The system has no means of isolation from the
supply voltage. When the mains plug is connected to the power line or the cable is clamped
into the DC supply, the system is powered,
even if the DIAMENTOR E2 is turned off.
The DIAMENTOR E2 can be connected with two
different adapters for supply voltage (refer to figure 2).
1. Connection with PTW power supply T99052
2. Connection with power limiter T26060 to an
external supply voltage according to IEC 606011/ ANSI/AAMI ES 60601-1 /
CAN/CSA-C22.2.No.60601-1
To connect the DIAMENTOR E2 follow the description of the used adapter.
1
PTW
Mains
(110... 230)VAC
2
External
Supply Voltage
Double /
Reinforced
insulation
IEC 60601-1
2 MOPP
24 VDC+/-10%
Power Supply
T99052
PTW
T26060
Figure 4: DIAMENTOR E2 connecting options
PTW T25024-2
PTW T25024-2
PTW
DIAMENTOR E2
PTW
DIAMENTOR E2
PTW
Chamber
PTW
Chamber
12
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DIAMENTOR E2
First Time Operation
4.2.1 Connection with PTW power supply T99052
WARNING
The device is designed to meet the requirements of protection class II. It may be operated
only with PTW power supply T99052.
Extension cords must not be used.
The DIAMENTOR E2 is connected via external
power supply T99052 to the mains (refer to
3, item 1).
CAUTION FOR USA
Installation in USA - In case of a 240 VAC-
line voltage the DIAMENTOR E2 must only be
connected to center tapped circuits.
The DIAMENTOR E2 is connected to the power
supply via supply cable T25024-2.
Figure
• Place the power supply so that mechanical
damages and penetration of liquids are
avoided. Do not place the power supply on the
ground!
Avoid injury hazard due to cable loops!
• Connect the power supply unit to the adapter
socket (refer to
necting the power supply unit to the power supply line, verify that the ratings of your local
power line are those indicated on the power
supply.
Figure 3, item 4). Before con-
4.2.2 Connection with power limiter T26060 to external supply voltage
CAUTION
Make sure that the release of the installation
manufacturer is on your hand before you connect the DIAMENTOR E2 via power limiter
T26060 to the installation.
WARNING
The power source has to guarantee safety by
means of 2 MOPPs (Means Of Patient Protection) according to IEC 60601-1/
ANSI/AAMI ES 60601-1/
CAN/CSA-C22.2.No.60601-1.
The DIAMENTOR E2 may be operated only
with power limiter T26060. Extension cords
must not be used.
The connection of the power limiter T26060 requires technical know-how and may only be
performed by trained electrotechnical staff according to IEC 60601-1/ANSI/AAMI ES 60601-1
/CAN/CSA-C22.2.No.60601-1.
The DIAMENTOR E2 is connected to the power
limiter T26060 via supply cable T25024-2 and to a
low voltage supply (24 VDC) (refer to
item 2).
Figure 3,
• Place the power limiter so that mechanical
damages and penetration of liquids are
avoided.
Do not place the power limiter on the ground!
Avoid injury hazard due to cable loops!
• Connect the power limiter unit via supply cable
T25024-2 to the adapter socket (refer to
3, item 4). Before connecting the power limiter
to the DC supply voltage, verify that the ratings
of the DC supply voltage are those indicated on
the power limiter.
D651.131.00/05 en 13
Figure
Page 14
DIAMENTOR E2
First Time Operation
Installation of the power limiter T26060 (refer to
Figure 5)
The DIAMENTOR E2 may be operated only with
power limiter T26060 in compliance with the following conditions.
• The earth and enclosure leakage currents of the
whole installation have to be measured when
putting into operation. The earth and enclosure
leakage current may not exceed the maximum
values of 300 µA (safety class I) or 150 µA
(safety class II) depending on the safety class.
• The user replaceable mains (line) fuse must be
an approved type acceptable to the authorities
where the equipment is sold.
• The complete system has to be evaluated ac-
cording to the requirements of IEC 60601-1
ANSI/AAMI ES 60601-1/
CAN/CSA-C22.2.No.60601-1 by the end user.
• To achieve the requirements for electro-
magnetic compatibility it is recommended to
connect the DC power supply output to GND
and earth (refer to
tion has no protective function (function earth).
Maximum Earth and Enclosure Leakage Current
Measurement according to IEC 62353
Class I equipment:
The maximum leakage current is 300 µA.
Class II equipment:
The maximum leakage current is 150 µA.
Figure 5). This earth connec-
Power Supply
Double / Reinforced
insulation
IEC 60601-1
2 MOPP
24 VDC ±10%
Power GND
24 VDC
white
brown
GND
Earth Connection
Figure 5: Installation of the power limiter T26060
PTW
T26060
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DIAMENTOR E2
First Time Operation
4.3 Connecting the Chamber and Printer and Putting into Operation
• Always turn off the device before connecting or
removing peripheral devices.
• Connect the chamber to 3 (refer to Figure 3).
Use the original cables from PTW (available in
various lengths up to 40 meters (130 ft)).
• Socket SERIAL (Figure 3, item 1): Connect the
printer cable or RS232 interface cable for PC.
• Turn on the DIAMENTOR E2 with the On/Off
switch (refer to
version will be displayed for about 2 seconds,
followed by a display test. After completion of
the test the DIAMENTOR E2 is operational.
Figure 3, item 5). The firmware
4.4 Mounting the ionization chamber
General information
The DIAMENTOR E2 can be operated with every
PTW-DIAMENTOR chamber featuring connecting
system A (
The chamber calibration factor must be entered for
the connected chamber (section
ing the chamber, do not forget to enter the new
chamber calibration factor (section
The DIAMENTOR E2 connection cables are available in various lengths (max. 40 meters (130 ft.)).
Use only the original cables from PTW.
Figure 3, item 3).
4.5). When replac-
4.5.)
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DIAMENTOR E2
First Time Operation
4.5 Basic Device Settings (Setup Menu)
General information
The setup menu will be activated by pressing the
TEST and RESET buttons simultaneously for about
2 seconds In the menu mode the buttons are used
for cursor control, to change and confirm settings
and to quit a menu.
All adjustments performed in the setup menu are
saved to the non-volatile memory.
Selecting a measuring quantity
When the setup menu is called up, the current settings for the measuring quantity are shown. The
settings available for the measuring quantity are
− dose area product doSE
− dose area product rate doSEr
− During irradiation display
of the detected dose area
product rate; after irradiation
display of the total dose
area product Auto
Entering the chamber calibration factor
Check the setting for the chamber calibration factor.
The original chamber factor K
is indicated on the
G
chamber housing.
Each time you connect another chamber, you
should enter the new chamber calibration factor as
described below.
To change the chamber calibration factor confirm
the setting for the measuring quantity with RESET
(
↵). The menu item for setting the chamber calibra-
tion factor CHAF will be called up automatically.
The current setting for the chamber calibration factor will be displayed. Change the current digit with
PRINT (↑) and move to the next digit with TEST
(→).Chamber calibration factors can be set in the
range (0.01 ... 9.99).
Confirm the selected setting with RESET (↵). After
confirmation, the measuring mode will be entered
automatically. The print mode can be switched on /
off with TEST button (display Prn on / Prn off).
PC can be connected only with disabled print mode.
If the print mode is set to ”Prn off” the print function
of PRINT button is inactive. To obtain a printout of
the measured values, first activate print mode.
Use the TEST (→) button to toggle between the
available settings. Confirm the selected setting with
RESET (↵). After confirmation, the menu item for
setting the chamber calibration factor will be called
up automatically.
NOTE
Ionization chambers calibrated by PTWFreiburg are suitable for over couch tubes and
under couch tubes. To compensate for the calibration error inherent in the system, the chamber calibration factor may be multiplied by a cor-
rection factor. The correction factor for over
couch tubes is 1.10, for under couch tubes,
0.95 (refer to section 7).
We recommend to have the system calibrated
annually or every 2 years by specially trained
staff on site or in our calibration laboratory of
PTW-Freiburg.
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DIAMENTOR E2
Performing a Measurement
5 Performing a Measurement
5.1 Constancy Check
CAUTION
Faulty measurement - Check the device per-
formance every day, before putting the
DIAMENTOR E2 into operation.
Before using the DIAMENTOR E2, check that
its measurement range matches the examination technique that will be applied.
Reset the DIAMENTOR E2 before each examination.
The DIAMENTOR E2 will conduct an internal constancy check as soon as the TEST button is
pressed for 2 seconds. The return value of the
hardware test is the proportional relation between
measured value and an internal test value. After
about 5 seconds the DIAMENTOR E2 returns automatically to the measuring mode.
After the device has been turned on, the firmware
version has been displayed for about 2 seconds
and the display test has been completed successfully measured values are displayed according to
the selected mode as soon as radiation is detected.
„Auto“ measuring mode (Setup: Auto)
During irradiation display of the detected dose area
product rate in µGym²/s; after irradiation display of
the total dose area product in µGym².
„Dose rate“ measuring mode (Setup: doSEr)
Display of the dose area rate in µGym²/s. This
mode is indicated by a square at the left margin of
the display.
„Dose“ measuring mode (Setup: doSE)
Display of the total dose area product in µGym². In
this mode the display will be refreshed every second.
If the proportional relation between measured value
and test value is not within the range of 95 ... 105
the device needs to be calibrated before it can be
used again.
5.2 Measurement
NOTE
Allow for a pause of at least 10 seconds between the activation of the device and the first
measurement (section 10).
Press the RESET button before starting the first
measurement to bring the DIAMENTOR E2 into
a defined initial state.
CAUTION
Faulty measurement - Accessories placed be-
tween the chamber and the patient, such as a
pediatric filter or beam applicator, will reduce
the dose area product relevant for the patient.
In this situation the DIAMENTOR E2 will display
measuring values that are too high. According
to national regulations in Germany, however, it
is sufficient to record the measuring value and
the accessories in use for reconstruction of the
radiation exposure level. If these accessories
are used for all measurements, the
DIAMENTOR E2 should be recalibrated with
the accessories installed.
Equipment damage - The DIAMENTOR E2
should be operated only when an ionization
chamber is connected or when the chamber
connection at the device is covered.
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DIAMENTOR E2
Performing a Measurement
5.3 Air Density Correction
To get the highest possible measuring accuracy the
indicated / determined value of the
DIAMENTOR E2 must be multiplied with a correction factor to the air density correction.
The air density correction factor is calculated by the
following formula:
Tp
•
K
= 1 013 hPa
p
0
p = current air pressure
T
0
T = current temperature
According to device, the correction can perhaps be
executed over a correction menu or an used software.
0
=
D
= 293 K (= 20°C)
Tp
•
0
5.4 Print out
The print mode can be switched on / off (display
Prn on / Prn off) over setup menu (refer to sec-
tion
4.5).
• Set print mode to “Prn on”
• Connect the printer to the DIAMENTOR E2
(refer to
• Press the PRINT button to obtain a printout of
the measured value.
• To start a new measurement press the RESET
button to reset the display to zero.
Figure 3, item 1).
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DIAMENTOR E2
Error Messages and Troubleshooting
6 Error Messages and Troubleshooting
Message Cause Remedy
OFL-Err (Overflow
Error)
Error 51 communication error Turn the device off and on again. When
Error 54 Memory malfunction Turn the device off and on again. When
HU-Err Chamber voltage missing, device is un-
The dose area product has exceeded
20 000 000 µGym²
or
the dose area product rate has exceeded
15 000 µGym²/s
able to measure
Press the RESET button.
the message appears again the device
must be repaired.
the message appears again the device
must be repaired.
Disconnect the chamber cable from the
DIAMENTOR E2. When the message
continues appearing the device is defec-
tive and must be repaired.
When the message clears the chamber
cable is defective and must be replaced.
D651.131.00/05 en 19
Page 20
7 Calibration
DIAMENTOR E2
Calibration
Electrical Calibration
The DIAMENTOR E2 is electrically calibrated in the
factory. You can verify the calibration as described
in section
5.2. If the electrical calibration values are
outside the admissible range, the device should be
returned to PTW-Freiburg for repair, as the electrical calibration cannot be corrected on site.
Radiological Calibration
The chamber calibration can be verified on site (see
below) or in the PTW calibration laboratory. We
recommend to have the system calibrated annually
or every 2 years in our calibration laboratory of
PTW-Freiburg.
Some Basic Facts On Chamber Calibration
(PTW-Freiburg Calibration Laboratory)
− For verification of the chamber calibration fac-
tor only the ionization chamber (without the
measuring system) needs to be returned to the
factory.
− The ionization chambers calibrated in the PTW
calibration laboratories can be used with overcouch and undercouch tubes.
− In order to take into account the different ab-
sorption conditions of overcouch and undercouch tubes, an additional absorber equivalent
to 0.35 mm AI is placed between the X-ray
tube and the ionization chamber during the
factory calibration. Therefore the measurement error of overcouch tube installations
where there is no absorber between chamber
and patient is up to - 9 %. In conjunction with
undercouch tubes the absorption of the patient
couch situated between the patient and the
chamber is equivalent to 0.5 to 0.7 mm AI,
which results in a measurement error of up to
+ 5 %.
− Enter the new chamber calibration factors as
described in section
chamber calibration factor K
4.5. For this, multiply the
by a correction
G
factor of 1.10 for over-couch tubes and of
0.95 for under-couch tubes.
Verifying the Chamber Calibration in Conjunction with the X-Ray System
Specially trained staff will be able to perform the
chamber calibration on site. The required accessories/tools are:
− 1 diagnostic dosemeter (e.g., PTW-DIADOS,
PTW-DALi, PTW-NOMEX or PTW-UNIDOS)
− 1 X-ray film, 13 cm x 18 cm (for radiography)
− 1 measurement phantom (for fluoroscopy)
− 1 adapter for DIADOS detector (part no.
T20002), (for fluoroscopy)
Check the electrical calibration as described in section
5.1.
Radiography
− Make adjustments for a field size of approx.
10 cm x 10 cm and mark the area on the patient couch.
− Place the X-ray film on the patient couch and
make a radiograph (70 kV and 40 mAs).
− Develop the film (only briefly to obtain sharp
edges) and measure the exact size of the field
(noting down the result A).
− Place the detector of the diagnostic dosemeter
in the center of the area marked on the patient
couch. Make a radiograph (70 kV and 40 mAs).
− The chamber calibration factors are noted
down on the calibration certificate.
20
D651.131.00/05 en
Page 21
DIAMENTOR E2
Calibration
− Note down the reading M
Reference
shown on the
diagnostic dosemeter.
− Note down the dose area product reading
shown on the DIAMENTOR E2 (DAP
Measured
).
− Calculate the dose area product
DAP
Calc
= M
Reference
x A where A is the field size.
− Repeat the measurement 3 times, noting down
the results.
Fluoroscopy (undercouch tube)
− Place the measurement phantom without de-
tector on the patient couch (phantom at the bottom).
− Start fluoroscopy and determine the field size A
in the plane of the phantom by means of the
phantom depicted on the screen.
Fluoroscopy (overcouch tube)
− Place the measurement stand without detector
on the patient couch (phantom at the top).
− Start the fluoroscopy and determine the field
size in the plane of the phantom by means of
the phantom depicted on the screen.
− Turn the measurement stand and put the detec-
tor and its holder in place (phantom at the bottom, detector at the top).
− Start another fluoroscopy for approx.
30 seconds.
− Note down the reading M
Reference
shown on the
diagnostic dosemeter.
− Note down the dose area product reading
shown on the DIAMENTOR E2 (DAP
Measured
).
− Turn the measurement stand and put the detec-
tor and its holder in place (phantom at the top,
detector at the bottom).
− Start another fluoroscopy for approx.
30 seconds.
− Note down the reading M
Reference
shown on the
diagnostic dosemeter.
− Note down the dose area product reading
shown on the DIAMENTOR E2 (DAP
Measured
).
− Calculate the dose area product
DAP
Calc
= M
Reference
x A where A is the field size.
− Repeat the measurement 3 times, noting down
the results.
− Calculate the dose area product
DAP
Calc
= M
Reference
x A where A is the field size.
− Repeat the measurement 3 times, noting down
the results.
Calculating the New Chamber Calibration Factor
− Calculate the mean value of (dose area prod-
uct) DAP
−
Calculate the mean value of (dose area product) DAP
.
Calc
Measured
.
− Calculate the new chamber calibration factor
K
, using the mean values and the old cham-
new
ber calibration factor:
DAP
K
new
=
DAP
Calc
Measured
K
⋅
old
Saving the New Chamber Calibration Factor
Enter the new chamber calibration factor as described in section
4.5.
D651.131.00/05 en 21
Page 22
8 Peripherals
DIAMENTOR E2
Peripherals
8.1 Printer
WARNING
Please read the printer manual before putting
the printer into operation!
The DIAMENTOR E2 may be operated in the
patient environment only if the connected
printer meets the requirements of IEC 60950-1 /
UL 60950-1 and if the printer is operated outside the patient environment.
The connected printer meets the requirements
of IEC 60950-1/ UL 60950-1 only if it is operated with the supplied original power supply.
To obtain a printout of the measured value connect
the printer to the DIAMENTOR E2 (
item 1).
Switch on the printer first or simultaneously with the
DIAMENTOR E2. Set the print mode to “Prn on”
(see section
The printout contains the device designation „PTW
DIAMENTOR E2“ and the measured value:
4.5).
PTW DIAMENTOR E2
Figure 3,
8.2 PC
WARNING
Please read the printer manual before putting
the printer into operation!
Operate the DIAMENTOR E2 in the patient environment only if the connected PC fulfills the
requirements of the IEC 60950-1 / UL 60950-1
and is installed outside the patient environment.
The PC connected to the device must comply
with the standards IEC 60601-1/
ANSI/AAMI ES 60601-1/
CAN/CSA-C22.2.No.60601-1 if it is to be operated in the patient environment.
WARNING
Before connecting a PC via the RS232 inter-
face, set the print mode to “Prn off” (see sec-
tion 4.5).
Use only the original RS232 interface cable
T25030-3.
It is also possible to connect a PC to the RS232
interface of the DIAMENTOR E2 (socket SERIAL).
22
12.34 uGym2
When connecting a PC to the DIAMENTOR E2,
please pay close attention to the safety information
in section
A detailed description of the interface is supplied on
request: document number D651.131.1.
2.
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DIAMENTOR E2
Cleaning, Preventive Maintenance and Disposal
9 Cleaning, Preventive Maintenance and Disposal
9.1 Cleaning
Ionization chambers
The outer shells of the ionization chambers are
made of macrolon (polycarbonate). The electrode
surfaces are made conductive by vacuum metallization. In this process a transparent metal coating is
applied to the electrode. In order to keep the coating transparent, ionization chambers must not be
treated or come into contact with alcohol or solvents.
Cleaning agents and solvents contained in disinfectants (alcohols) have proved to be particularly
harmful.
• Wipe the chambers clean with a moist cloth.
• Please use a common disinfection agent for
medical instruments that is listed in your national
hygiene institute (e.g., VAH in Germany). If your
country does not provide such a list we recommend using either an aldehyde based solution or
a solution with a quaternary ammonium compound.
Surface
Connection cables
• disconnect the cables from the devices, pulling
on the plug, not on the cable
• for cleaning, rub the cables down with a cloth
moistened with soap water or disinfectant
• never immerse the cable in liquid!
9.2 Preventive Maintenance
WARNING
Hazards to Persons! Equipment Damage!
Only specially trained staff is allowed to perform
the following service tasks.
Further service tasks may only be carried out by
PTW-Freiburg or by persons authorized by
PTW-Freiburg.
Check before each use
− Before each use, visually inspect the device
and the cables for signs of mechanical damage
CAUTION
Equipment damage - Do not use disinfectants
on a phenol base or peroxide compounds to
disinfect the surface.
• First of all, disconnect the devices from the
power line, before attempting to clean or disinfect them.
• Rub the devices down with a moist cloth; no
liquid must enter the devices. Due to the surface geometry, a thorough disinfection is not
possible. The device cannot be sterilized.
D651.131.00/05 en 23
− Also, conduct a constancy check as described
in section
− If damages or malfunctions are identified, the
device must be repaired before it is used
again.
Repair
Repairs may only be carried out by PTW-Freiburg
or by persons / companies authorized by
PTW-Freiburg.
5.1.
Page 24
DIAMENTOR E2
Cleaning, Preventive Maintenance and Disposal
Safety inspections
Only regularly inspected product s are fail-safe. To
preserve the functional security and operational
safety, the safety inspections are 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
annually or every 2 years.
Technical Inspection of the Measuring Systemm
The product must be inspected at regular intervals
according to national regulations. It is recommended to perform the technical inspections of the
measuring system annually or every 2 years at
PTW-Freiburg or a qualified calibration laboratory.
9.3 Disposal of the Product
The typical lifetime of the DIAMENTOR E2 is about
10 years.
At the end of the product life ears the
DIAMENTOR E2 components must be disposed of
in compliance with the applicable waste control
regulations. The different materials must be separated and recycled as appropriate.
DIAMENTOR E2 does not contain hazardous materials.
The electronic components must be recycled according to local regulations.
The cost for an eventual return at the end of the
product life time is to be borne by the customer.
Inspections must also be performed after repairs or
after each influence which may have changed the
behavior of the product.
Calibration
The exact calibration factor and supplementary data
are included in the calibration certificate.
We recommend to have the DIAMENTOR E2 calibrated annually or every 2 years at PTW-Freiburg
or by specially trained staff on site.
24
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Page 25
DIAMENTOR E2
Technical Specifications
10 Technical Specifications
Only values for which tolerances or limits are specified are guaranteed. Values for which no tolerances are
specified are for information only.
Device designation and use DIAMENTOR E2 T11033
dose area product meter according to IEC 60580 for measurements
in diagnostic radiology
Manufacturer PTW-Freiburg
Display LED, 8 digit seven-segment display; red
Number of measuring channels 1
Measuring principle detection of irradiation by means of ionization chambers, analog
and digital signal processing, digital readout on LED
Operating mode continuous operation
Measuring quantities Dose area product, dose area product rate
Linearity deviation < 2.5 %
Offset current (zero drift) < 0.2 pA at 25°C
Settling time max.2 s
Operational readiness 10 s after power up
Nominal useful range dose area product (DAP) rate
Dose area product (DAP)
Unit: µGym²
Measuring range: (0.1 ... 20 000 000) µGym²
Accuracy: ± 1 digit
Digital resolution: 0.01 µGym²
Dose area product (DAP) rate
Unit: µGym²/s
Measuring range: (0.1 ... 15 000) µGym²/s
Accuracy: ± 1 digit
Digital resolution: 0.01 µGym²/s
(0.01 .... 15 000) µGycm²/s
D651.131.00/05 en 25
Page 26
DIAMENTOR E2
Technical Specifications
Chamber voltage + 300 VDC ± 10 V
Current limitation of the chamber volt-
< 0.1 mA
age
Power 24 VDC ± 10 %
Power input 3 W max.
Protection class II according to IEC 60601
Electromagnetic compatibility
Suitable for use in an electromagnetic environment according to
IEC 60601-1-2
Dimensions (W x H x D) 83 mm x 36 mm x 151 mm
Weight 250 g
Adapter
Power supply T99052
Input (100 ... 240) VDC / 0,33-0,18 A / (47 ... 63) Hz
Output 24 VDC / 0,62 A
Power limiter T26060
Input 24 VDC ± 10 %
Output 24 VDC ± 10 % / 9 VA
Environmental conditions
Transport and storage
Ambient temperature: (-20 ... +60) °C, (-4 … +140) °F
Rel. humidity: (10 ... 85) %, no condensation (max. 20 g/m³ absolute humidity)
Atmospheric pressure: (600 ...1 200) hPa
Operation
Ambient temperature: (+10 ... +40) °C, (+50 ... +104) °F
Rel. humidity: (10 ... 80) %, no condensation (max. 20 g/m³ absolute humidity)
Atmospheric pressure: (700 ... 1 060) hPa
Max. operation altitude 3 000 m a.s.l
26
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DIAMENTOR E2
Accessories and Spare Parts
11 Accessories and Spare Parts
Order No.
T11033 DIAMENTOR E2, DAP meter
T25024-2 Supply cable 24 VDC
T99052 Power supply according to
IEC 60601-1
T26060 Power limiter
T25030-3 RS232 interface cable
L104078 Wall mount for DIAMENTOR E2
on request DIAMENTOR chamber
This list of accessories and spare parts is valid at
the time of document
accessories and spare parts is available on request.
creation. The current list of
12 Special Adjustments
General information
CAUTION
The adjustments described below must only be
carried out by specially trained service technicians.
Call up the Service menu by pressing the TEST and
PRINT buttons simultaneously. In the Service menu
mode the buttons are used for cursor control, to
change and confirm settings and to quit a menu.
Electrical calibration
When the Service menu is called up the current
setting for the electrical calibration factor CAL will
be shown. The factor is adjustable in the range
(0.01 ... 9.99).
Change the current digit with PRINT (↑) and move
to the next digit with TEST (→). Confirm the selected setting with RESET (↵). After confirmation,
the menu for setting the test value will be entered
automatically. The electrical calibration factor will be
saved to the non-volatile memory.
Setting the test value
The menu for setting the test value will be entered
automatically when the setting for the electrical
calibration factor CAL in the Service menu (see
above) has been confirmed with RESET(↵).
The display shows dashes (---) and after a short
time the 4-digit test value. With RESET (↵) this
value will be confirmed and the measuring mode
will be entered automatically. The test value will be
saved to the non-volatile memory.
D651.131.00/05 en 27
Page 28
DIAMENTOR E2
Electromagnetic Compatibility (EMC) according to IEC 60601-1-2 / Special Adjustments
13 Electromagnetic Compatibility (EMC) according to
WARNING
Equipment failure!
IEC 60601-1-2
The DIAMENTOR E2 should not be used in
immediate proximity to other devices, or while
stacked with other devices. Should this be nec-
WARNING
Equipment failure!
The use of cables longer than the specified
ones can lead to a deterioration of the electromagnetic compatibility of the DIAMENTOR E2.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The DIAMENTOR E2 is intended for use in the electromagnetic environment specified below.
The customer or the user of the DIAMENTOR E2 should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
Radio-Frequency Emissions
IEC/CISPR 11
Group 1
The DIAMENTOR E2 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.
essary, the DIAMENTOR E2 should be observed in order to ensure operation according to
prescribed conditions and regulations.
Radio-Frequency Emissions
IEC/CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Class B
complies
complies
The DIAMENTOR E2 is suitable for use in all establishments, including domestic establishments and those
directly connected to the low-voltage power supply network that supplies buildings used for domestic purposes.
1
1
The DIAMENTOR E2 fulfils the requirements of IEC/CISPR 11 Class B, anyhow according to its intended use it is not for
operation in domestic establishments.
28
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DIAMENTOR E2
Electromagnetic Compatibility (EMC) according to IEC 60601-1-2
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The DIAMENTOR E2 is intended for use in the electromagnetic environment specified below. The customer or
the user of the DIAMENTOR E2 should assure that it is used in such an environment.
Immunity Test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast
transient / burst
IEC 61000-4-4
Surges
IEC 61000-4-5
Voltage dips, short interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
(
tested using power supply
T99042
)
IEC 60601
Test Level
± 6 kV
contact
± 8 kV
air
± 2 kV
for power supply lines
± 1 kV
for input / output lines
± 1 kV
line(s) to line(s)
± 2 kV
line(s) to earth
< 5 % U
(> 95 % dip in U
T
) for
T
0.5 cycle
40 % U
(60 % dip in U
T
) for
T
5 cycles
70 % U
(30 % dip in U
T
) for
T
25 cycles
< 5 % U
(> 95 % dip in U
T
) for 5 s
T
Compliance Level
± 6 kV
contact
± 8 kV
air
± 2 kV
for power supply lines
± 1 kV
for input / output lines
± 1 kV
line(s) to line(s)
± 2 kV
line(s) to earth
< 5 % U
(> 95 % dip in U
T
) for
T
0.5 cycle
40 % U
(60 % dip in U
T
) for
T
5 cycles
70 % U
(30 % dip in U
T
) for
T
25 cycles
< 5 % U
(> 95 % dip in U
T
) for 5 s
T
Electromagnetic Environment - Guidance
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity should be at least 30 %.
Mains power quality should
be that of a typical commercial or hospital environment.
Mains power quality should
be that of a typical commercial or hospital environment.
Mains power quality should
be that of a typical commercial or hospital environment.
If the user of the
DIAMENTOR E2 requires
continued operation during
power mains interruptions, it
is recommended that the
DIAMENTOR E2 be powered from an uninterruptible
power supply or a battery
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial or hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
D651.131.00/05 en 29
Page 30
DIAMENTOR E2
Electromagnetic Compatibility (EMC) according to IEC 60601-1-2 / Special Adjustments
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The DIAMENTOR E2 is intended for use in the electromagnetic environment specified below.
The customer or the user of the DIAMENTOR E2 should assure that it is used in such an environment.
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601
Test Level
3 V
rms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Compliance
Level
V
= 10 V
1
rms
E
= 3 V/m
1
Electromagnetic Environment – Guidance
Portable and mobile RF communications equipment
are used no closer to any part of the
DIAMENTOR E2, including cables, than the recommended separation distance calculated from the
equation appropriate for the frequency of the transmitter.
Recommended Separation Distance
2
d =
5.3
P
=
V
1
1.2 P
3
5.3
d =
E
=
1.2 P
P
1
80 MHz to 800 MHz
7
=
d =
E
1
2.3 P 800 MHz to 2.5 GHz
P
where P is the power rating of the transmitter in
watts (W) according to the transmitter manufacturer
and d is the recommended separation distance in
meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,
than the compliance level in each frequency range.
a)
are less
b)
Interference may occur in the vicinity of equipment
marked with the following symbol:
a)
Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be estimated accurately. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be performed. If the
measured field strength exceeds the RF compliance level above, observe the DIAMENTOR E2 to verify normal opera-
tion in each use location. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the DIAMENTOR E2.
b)
Over the frequency range 150 kHz to 80 MHz, field strengths are less than 3 V/m.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and re-
flection from structures, objects and people.
2
different test level from product standard IEC 60580 (IEC 61000-4-6) was used
3
calculation with test level of IEC 60601-1-2
30
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DIAMENTOR E2
Electromagnetic Compatibility (EMC) according to IEC 60601-1-2
Recommended separation distances between portable and mobile RF communications equipment and
the DIAMENTOR E2
The DIAMENTOR E2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the DIAMENTOR E2 can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the DIAMENTOR E2 as recommended below, according to the maximum output power of
the communications equipment.
Rated maximum out-
put power of transmit-
Separation distance according to frequency of transmitter
(m)
ter (W)
0.01
0.1
1
10
100
150 kHz to 80 MHz
5.3
d =
P
V
= 1.2 P
1
0.12 0.12 0.23
0.38 0.38 0.73
1.2 1.2 2.3
3.8 3.8 7.3
12 12 23
80 MHz to 800 MHz
5.3
d =
E
P
1
= 1.2 P
800 MHz to 2.5 GHz
7
d =
E
1
= 2.3 P
P
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
D651.131.00/05 en 31
Page 32
DIAMENTOR E2
Appendix: China Electronic Industry Standard Compliance / Special Adjustments
Appendix: 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 M arking 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
This symbol indicates the product contains hazardous materials in excess of the limits estab-
lished 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。
32
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有单独的标识，其环保使用期限有可能产品本身的环保使用
期限。应按产品维护程序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。
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DIAMENTOR E2
Appendix: China Electronic Industry Standard Compliance
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.
表1 - 有毒有害物质的名称及含量
Component Name
部件名称
Display
显示设备
Others
其它
(Pb)
（铅）
(Hg)
（汞）
X X X X X X
X O X X X X
Hazardous substances’ name
有毒有害物质的名称
(Cd)
（镉）
(Cr(VI))
（六价铬）
(PBB)
（多溴联苯）
(PBDE)
（多溴二苯醚）
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。
D651.131.00/05 en 33
Page 34
DIAMENTOR E2
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 rela-
tion to medical exposure
[3] IEC 60601-1-2
Medical electrical equipment
Part 1-2: General requirements for basic safety and essential
performance -
Collateral Standard: Electromagnetic compatibility - Re-
quirements and tests
[4] IEC/CISPR 11
Industrial, scientific and medical (ISM) radio-frequency
equipment - Radio disturbance characteristics - Limits and
methods of measurement.
[5] IEC 60950-1
Information technology equipment - Safety
Part 1: General requirements
[6] IEC 60601-1 / ANSI/AAMI ES 60601-1/
CAN/CSA-C22.2.No.60601-1
Medical electrical equipment –
Part 1: General requirements for basic safety and essential
performance
[11] IEC 61000-4-2
Electromagnetic compatibility (EMC) -
Part 4-2: Testing and measurement techniques -
Electrostatic discharge immunity test
[12] IEC 61000-4-3
Electromagnetic compatibility (EMC) -
Part 4-3: Testing and measurement techniques -
Radiated, radio-frequency, electromagnetic field immunity
test
[13] IEC 61000-4-4
Electromagnetic compatibility (EMC) -
Part 4-4: Testing and measurement techniques - Electrical
fast transient/burst immunity test
[14] IEC 61000-4-5
Electromagnetic compatibility (EMC) -
Part 4-5: Testing and measurement techniques -
Surge immunity test
[15] IEC 61000-4-6
Electromagnetic compatibility (EMC) -
Part 4-6: Testing and measurement techniques -
Immunity to conducted disturbances, induced by radio-
frequency fields
[16] IEC 61000-4-8
Electromagnetic compatibility (EMC) -
Part 4-8: Testing and measurement techniques -
Power frequency magnetic field immunity test
[7] IEC 60580
Medical electrical equipment
Dose Area Product Meter
[8] IEC 62353
Medical electrical equipment –
Recurrent test and test after repair of medical electrical
equipment
[9] IEC 61000-3-2
Electromagnetic compatibility (EMC) -
Part 3-2: Limits -
Limits for harmonic current emissions (equipment input cur-
rent ≤ 16 A per phase)
[10] IEC 61000-3-3
Electromagnetic compatibility (EMC) -
Part 3-3: Limits -
Limitation of voltage changes, voltage fluctuations and flicker
in public low-voltage supply systems, for equipment with
rated current ≤16 A per phase and not subject to conditional
connection
[17] IEC 61000-4-11
Electromagnetic compatibility (EMC) -
Part 4-11: Testing and measurement techniques -
Voltage dips, short interruptions and voltage variations im-
munity tests
[18] IEC 60522
Determination of the permanent filtration of X-ray tube as-
semblies
34
D651.131.00/05 en
Page 35
Index
DIAMENTOR E2
A
Accessories and Spare Parts ........................................ 27
Air Density Correction ................................................... 18
Appendix ....................................................................... 32
C
Calibration ..................................................................... 24
Calibration factor, ionization chamber ........................... 16
Calibration, electrical..................................................... 27
Cleaning........................................................................ 23
Connecting.............................................................. 12, 15
Constancy Check .......................................................... 17
D
Disposal ........................................................................ 24
E
Electromagnetic compatibility.................................. 26, 28
Error Messages............................................................. 19
F
First Time Operation ..................................................... 12
G
General Information ........................................................ 2
I
Intended Use................................................................... 5
Ionization chamber, mounting ....................................... 15
L
Literature .......................................................................34
M
Maintenance .................................................................. 23
Measurement.................................................................17
O
Operating Controls and Indicators ................................. 11
P
PC .................................................................................22
Peripherals ....................................................................22
Print out .........................................................................18
Printer............................................................................22
R
Repair ............................................................................23
RS232 interface.............................................................22
S
Safety Information ...........................................................5
Safety inspections .........................................................24
Setting up ......................................................................12
Setup menu, basic settings............................................16
Special Adjustments ......................................................27
T
Technical Inspection of the Measuring System .............24
Technical Specifications ................................................25
Troubleshooting.............................................................19
D651.131.00/05 en 35
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