DIAMENTOR M4KDK Manual

User Manual
DIAMENTOR M4-KDK
T11017 from SN 001443 and
T11025 from SN 001914
firmware version 2.10 or higher
D428.131.00/08 en 2017-12 Hn
DIAMENTOR M4-KDK
T11017 from SN 001443 and T11025 from SN 001914
General Information
General Information
 The product bears the CE-mark "CE-0124" in  Operator safety, specified measuring accuracy
accordance with the Council Directive and interference-free operation can be guaran-
93/42/EEC about Medical Devices and fulfills teed only if original products and parts are
the essential requirements of Annex I of this used. Furthermore only the accessories listed
directive. The product is a class IIb device in this manual are approved by PTW-Freiburg
(MDD). and may be used in conjunction with the prod-
uct, or else accessories whose use has been
 With the help of the DIAMENTOR M4-KDK the expressly permitted by PTW-Freiburg. Safe
requirements of the EC patient guideline operation and proper product performance are
97/43/EURATOM can be fulfilled regarding the not guaranteed if accessories or consumables
acquisition and documentation of the radiation from other manufacturers are used.
exposure of patients during X-rays examina-
tion.  PTW-Freiburg cannot be held liable for dam-
ages resulting from the use of accessories,
 Product standard consumables from other manufacturers or
The product fully complies with the require- when the user ignores the instructions and in-
ments of the following standards: formation given in this manual.
EN 60580 (IEC 60580).
 The warranty period is 1 (one) year and begins
 Electrical safety on the day of delivery.
The product fully complies with the require- It is unaffected by repairs covered by the war-
ments of the following standards: ranty regulations.
EN 60601-1 (IEC 60601-1),
conforms to ANSI/AAMI Std. ES 60601-1,  PTW-Freiburg considers itself responsible for
certified to CAN/CSA Std. C22.2.No.60601-1. safety, reliability and performance of the prod-
uct only, if assembly, extension, readjustment,
 Electromagnetic immunity modification or repair is carried out by
The product fully complies with the require- PTW-Freiburg or by persons authorized by
ments of the following standards: PTW-Freiburg, and if the product is used in
EN 60601-1-2 (IEC 60601-1-2), compliance with the technical documentation.
EN 55011 (IEC/CISPR 11) class B.
 In case of any questions concerning service,
 The user manual is an integral part of the support or warranty please contact your sup-
product. It should always be kept near the plier.
product. Observance of the manual is a pre-
requisite for proper product performance and
correct operation.
2 D428.131.00/08 en
DIAMENTOR M4-KDK
General Information
 This manual is in conformity with the product

specifications and all applicable safety stand-
ards valid at printing date. All rights are re-
served for devices, circuits, techniques, soft-
ware and names referred to in the manual. PTW-FREIBURG
Physikalisch-Technische Werkstätten
 PTW-Freiburg reserves the right of modifica- Dr. Pychlau GmbH
tions. Please contact PTW or your local repre- Lörracher Str. 7
sentative for the most current information. 79115 FREIBURG
GERMANY
 No part of the technical documentation may be Phone: +49 761 49055-0
reproduced without written permission from Fax: +49 761 49055-70
PTW-Freiburg. info@ptw.de
www.ptw.de
 PTW-Freiburg is registered manufacturer ac-
cording to the ElektroG (Elektro- und Elektro-
nikgeräte-Gesetz).
Elektro-Altgeräte-Register (EAR) Registration
number DE15599992
 PTW-Freiburg works in strict accordance with

a quality management system which is contin-
uously updated according to national and in-
ternational standards.
D428.131.00/08 en 3
DIAMENTOR M4-KDK
Contents
Contents
General Information 2
Contents 4
Illustrations 5
1 Intended Use 6
2 For Your Safety 6
3 Operating Controls and Indicators 12
4 First-Time Operation 14
4.1 Mounting the Ionization Chamber 14
4.2 Wall mounting of the DIAMENTOR M4-KDK 15
4.3 Connecting the DIAMENTOR M4-KDK 16
4.4 System Configuration (Setup Menu) 17
4.5 Entering the Chamber Calibration Factors 29
5 Performing a Measurement 30
5.1 Constancy Check 30
5.2 Measurement 31
6 Error Messages and Troubleshooting 33
7 Calibration 34
8 Peripherals 37
8.1 Secondary Displays 37
8.2 Printers 39
8.3 PC 40
9 Cleaning, Preventive Maintenance and Disposal 41

9.1 Cleaning 41
9.2 Preventive Maintenance 42
9.3 Disposal of the Product 42
10 Technical Specifications 43
11 Electromagnetic compatibility according to EN 60601-1-2 (IEC 60601-1-2) 46
12 Accessories and Spare Parts 49
13 Special Adjustments 50
Literature 52
Appendix: China Electronic Industry Standard Compliance 53
Index 55
4 D428.131.00/08 en
DIAMENTOR M4-KDK
Illustrations
Illustrations
Figure 2-1: Definition of patient environment 10

Figure 3-1: DIAMENTOR M4-KDK, front view 12
Figure 3-2: DIAMENTOR M4-KDK, top view 13
Figure 4-1: Removing the rubber feet 15
Figure 4-2: Mounting the screw insert 15
Figure 4-3: Mounting the fixation straps 15
Figure 4-4: DIAMENTOR M4-KDK connectors 16
Figure 4-5: Setup menu 19
Figure 4-6: Display submenu 20
Figure 4-7: Example of display format 21
Figure 4-8: Date & Time submenu 24
Figure 4-9: Corrections submenu 25
Figure 4-10: Printer submenu 27
Figure 4-11: Calibration menu 29
Figure 5-1: Power switch 11 and TEST button 15 30
Figure 5-2: Test screen 30
Figure 5-3: DIAMENTOR M4-KDK, PRINT and RESET buttons 31
Figure 8-1: Secondary display with backlighting 38
Figure 8-2: Sample printout 39
Figure 13-1: Screws on secondary display 50
Figure 13-2: Jumper X2 on PCB 50
Figure 13-3: Removing the plastic clips 50
Figure 13-4: Line voltage selector 51
D428.131.00/08 en 5
DIAMENTOR M4-KDK
Intended Use
1 Intended Use 2 For Your Safety
The DIAMENTOR M4-KDK is a device for meas- The following safety statements are divided into
urement of the dose area product, the dose area DANGER, WARNING, CAUTION and NOTE.
product rate, the entrance dose and the entrance
dose rate in diagnostic radiology. The Definitions
DIAMENTOR M4-KDK fulfills the requirements of
EN 60580 (IEC 60580). DANGER
Indicates an imminent hazard. If not avoided,

The dose area product is measured with an ioniza- the hazard will result in death or serious injury.
tion chamber mounted directly to the light beam
diaphragm housing. Several different chambers are
available.
WARNING
The DIAMENTOR M4-KDK is a microprocessor-
Indicates a hazard. If not avoided, the hazard
controlled measuring system.
can result in death or serious injury.
The digital display can simultaneously show two of

the four measured values. The dose area product
rate is also indicated by a bar graph which starts CAUTION
flashing when the high limit is exceeded. Moreover,
Indicates a potential hazard. If not avoided, the
two additional digital displays, the secondary dis-
hazard could result in minor injury or product /
plays, can be connected which allow users to carry
property damage.
out all operations necessary to perform a meas-
urement.
A label printer can be connected (RS232 interface) NOTE

for documentation of the results. When a printer is
Provides useful information to assure that you
not used, a PC can be connected instead.
get the most from your equipment.
WARNING
For use with the DIAMENTOR M4-KDK, the

DIAMENTOR SD secondary display must have
firmware version 2.00 or higher.
6 D428.131.00/08 en
DIAMENTOR M4-KDK
For Your Safety
Safety Information
DANGER WARNING
Explosion Hazard – The product is not suitable Shock Hazard – Strictly observe the following
for operation in areas of risk where an explo- warnings. Failure to do so may endanger the
sion hazard may occur. Explosion hazards lives of the patient, the user and other persons
may be caused by the use of combustible an- involved.
aesthetics, skin-cleansing agents and disinfect-
 The installation of the product may only be
ants.
performed by trained electro-technical staff.
Furthermore the product is not suitable for ap-  Before using the product, the operator must
plication in oxygen-enriched atmospheres. ascertain that it is in correct working order
The atmosphere is considered to be oxygen- and operating condition.
enriched when more than 25 % of oxygen or ni-
 Before putting the device into operation, vis-
trous oxide is added to the ambient air.
ually inspect all connection cables for signs
of damage. Damaged cables and connectors
must be replaced immediately.
WARNING  The product is a device of EN 60601-1
Hazards to Persons! (IEC 60601-1) protection class I. Connect
the product only to a properly installed power
The product is a medical device used within a outlet with earthing contact.
radiologic environment. The product must only
 Before connecting the device to the power
be handled by personnel skilled in radiologic
line, verify that the ratings of your local pow-
applications.
er line are those indicated on the device
name-plate.
 Extension cords must not be used.
 All devices of a system must be connected
to the same electric circuit. Devices not con-
nected to that circuit must be electrically iso-
lated (RS232 interface with electrical insula-
tion).
 When disconnecting the device from the
power line, first remove the plug from the
wall outlet, then disconnect the power cord
from the device.
 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 device. If liquids
have entered the device, it must be thor-
oughly inspected before being used again.
D428.131.00/08 en 7
DIAMENTOR M4-KDK
For Your Safety
WARNING Use of peripheral devices:
Shock Hazard – Strictly observe the following  Connect only peripheral devices (PC, print-
warnings. Failure to do so may endanger the er) that meet the requirements of the stand-
lives of the patient, the user and other persons ard EN 60950-1 (IEC 60950-1) / UL 60950-1
involved. or the standard EN 60601-1 (IEC 60601-1) /
ANSI/AAMI ES 60601-1, CAN/CSA-
Operation in the patient environment: With
C22.2.No.60601-1.
all peripheral devices connected, the product
represents a medical system. The product may  Operate these devices in the patient envi-
be operated in the patient environment only if ronment only if it is guaranteed that all con-
nected peripheral devices meet the require-
 no peripheral devices are connected to the ments of the standard EN 60601-1
serial interface or
(IEC 60601-1) / ANSI/AAMI ES 60601-1,
 the connected peripheral devices meet the CAN/CSA-C22.2.No.60601-1.
requirements of the standard EN 60601-1  Devices may be connected to other devices
(IEC 60601-1) / ANSI/AAMI ES 60601-1,
or to parts of systems only if it has been as-
CAN/CSA-C22.2.No.60601-1
certained that this connection does not im-
 the connected peripheral devices meet the pair the safety of the patient, the operator or
requirements of the standard EN 60950-1 the environment.
(IEC 60950-1) / UL 60950-1 and are operat-
 If the device specifications do not contain in-
ed outside the patient environment (refer to formation as to connecting the device to oth-
Figure 2-1).
er equipment, you must consult the manu-
Exclusion of operation as device with pa- facturer of the other equipment or an expert
tient contact: about the effects of the connection on the
 The device is not for use in direct contact patient, the operator or the environment.
with the patient. Neither the device nor any  Always observe standards EN 60601-1
peripheral device may have contact to the (IEC 60601-1) / ANSI/AAMI ES 60601-1,
patient. CAN/CSA-C22.2.No.60601-1.
 Never touch the patient and open connect-
ors of the device at the same time.
Exclusion of operation as a controlling in-
strument:
 The device is only intended to measure the

dose within the radiation field. The product
must not be used to control radiodiagnostic
equipment or radiotherapy units.
8 D428.131.00/08 en
DIAMENTOR M4-KDK
For Your Safety
WARNING WARNING
Equipment failure - Electromagnetic fields are Bodily Injury! Equipment Damage!

capable of interfering with the proper perfor-
 Always apply the product in compliance with
mance of the device.
its intended use.
 For this reason make sure that all external  Modifications, additions or maintenance of
devices operated in the vicinity comply with the equipment may be conducted only by
the relevant EMC requirements. X-ray suitably qualified and trained persons.
equipment, MRI devices and radio systems
 Spare parts must be approved by the manu-
are possible sources of interference as they
facturer.
may emit higher levels of electromagnetic
radiation. Keep the DIAMENTOR M4-KDK  After the modification of the equipment, ap-
propriate inspections and tests have to be
away from these devices and verify its per-
carried out.
formance before use.
 The use of cables longer than specified may  Failure to comply may lead to fatal or serious
personal injury and / or damage to the
impair the electromagnetic compatibility
characteristics of the DIAMENTOR M4-KDK. equipment, as well as void the warranty.
 The DIAMENTOR M4-KDK should not be

used in the immediate vicinity of or placed
on top of or below other equipment. Howev- CAUTION
er, if the application requires an arrangement Bodily Injury! Equipment Damage!
of devices as described above, the
 Always use the product in compliance with
DIAMENTOR M4-KDK should be watched to
the user manual. Otherwise, the provided
ensure its proper functioning in the specific
protection may be impaired.
arrangement.
 Use the product only in conjunction with the
 Make sure that the product is used in an
products approved by PTW for this purpose
electromagnetic environment as described in
and/or the products listed in the section "In-
EN 60601-1-2 (IEC 60601-1-2).
tended Use".
 Connect the product to other devices or ac-
cessories only according to the given speci-
WARNING
fication.
If damages or malfunctions are identified, the  Use the product within the rated range of
device must be repaired before it is used again. use as indicated in the section "Technical
Specifications".
 Handle the product with care.
D428.131.00/08 en 9
DIAMENTOR M4-KDK
For Your Safety
CAUTION
Equipment damage - Before connecting the

device to the power line, make sure that line
voltage and frequency are equivalent to the rat-
ings indicated on the nameplate of the device.
Equipment damage - Set up the device in a lo-

cation which affords sufficient ventilation.
NOTE
Please observe the user manuals of all con-

nected devices!
NOTE
Set up the device so that the operator has a

clear, unobstructed view of the control panel.
Figure 2-1: Definition of patient environment

NOTE
Do not position the device so that it is difficult to

operate the disconnecting device.
10 D428.131.00/08 en
DIAMENTOR M4-KDK
For Your Safety
Symbols on Nameplate
Symbol Description
Follow the user manual.
Please refer to user manual.
The product bears the CE-mark.
The product is certified by CSA

(Canadian Standards Association)
for both the U.S. and Canadian
markets, to the applicable U.S.
and Canadian standards.
The product has been tested by
the SIQ (Slovenian Institute of
Quality and Metrology).
The device is only suitable for use
with direct current.
Manufacturer and date of manu-

facture
Reference number
Serial number
Separate collection for electrical

and electronic equipment!
(refer also to section Disposal of
the Product)
Labeling according to “Administra-
tion on the Control of the Pollution
caused by Electronic Information
Products (ACPEIP)“ (China RoHS)
(refer also to Appendix)
For a description of additional symbols, if appli-
cable, please refer to the equipment description.
D428.131.00/08 en 11
DIAMENTOR M4-KDK
Operating Controls and Indicators
3 Operating Controls and Indicators
Figure 3-1: DIAMENTOR M4-KDK, front view
Controls and indicator Symbol

1 Digital display ---
2 Button to reset to zero the dose area product and entrance dose readings as well as the RESET
time and to quit the setup menu without saving the modified settings. Secondary dis-
plays connected are also reset. Depending on the setup-menu configuration, RESET will
also initiate a printout; refer to section 4.4. In addition, the button is used to terminate entry
of the chamber-patient distance without saving the new value.
3 Cursor control button used in the setup menu (up) and to enter the chamber-patient dis- 
tance
4 Button to access submenus of the setup menu and to enable the chamber-patient dis- ENTER
tance entry mode
5 Cursor control button used in the setup menu (down), to enter the chamber-patient dis- 
tance and to display the calibration menu (refer to section 7)
6 Contrast adjustment ◑
7 Button to initiate a printout and to quit the setup menu, saving the modified settings. In PRINT
addition, the button is used to terminate entry of the chamber-patient distance, saving the
new value.
12 D428.131.00/08 en
DIAMENTOR M4-KDK
Operating Controls and Indicators
Figure 3-2: DIAMENTOR M4-KDK, top view
Controls and indicator Symbol
8 Chamber connection B
9 High-voltage fuse for ionization chamber T32mAL, 250 V
10 Chamber connection A
11 Power switch on/off I O
12 Power input fuse
115 V: 2x T200 mAH, 250 V
230 V: 2x T125 mAH, 250 V
13 Power input
14 Nameplate (on rear panel)
15 Button to perform a constancy check of the device (section 5.1) TEST
16 Serial interface for connection of a printer or PC SERIAL
17 2 connectors for secondary displays (section 8.1) DISPLAY
D428.131.00/08 en 13
DIAMENTOR M4-KDK
First-Time Operation
4 First-Time Operation
4.1 Mounting the Ionization Assembly

Chamber
There are bore holes in the frame of the chamber
for mounting the ionization chamber to the system
CAUTION in two ways:
Risk of Injury - Ensure that the DIAMENTOR
 you attach the chamber directly to the housing of
chamber is securely mounted. Otherwise, the
the light beam diaphragm or
DIAMENTOR chamber may drop during the
measurement and hurt the patient.  you attach two rails to the chamber frame which
allow you to insert the chamber in the corre-
sponding guidance on the diaphragm frame.
CAUTION The DIAMENTOR M4-KDK connection cables are

Shock Hazard - During operation, the chamber available in various lengths (40 meters (130 ft.)
must not come into contact with water or water max.). Use the original PTW cables only.
vapor. Also refer to section 9.
The connection cable has:
 an inner conductor connected to the collector

CAUTION electrode,
Mismeasurement - Check the calibration regu-  a primary shield connected to the grounded
larly every 2 years. Also refer to section 7. conductor,
 a second, concentric conductor connected to the

chamber voltage of + 400 Volts and
Some Basic Facts  a third, outer shield, again connected to ground.
There are several ionization chamber models avail- The metal shells of the connectors and couplings
able (refer to section 12). The inherent filtration of are connected to the outer shield (ground). With the
the chamber is indicated on the nameplate (specifi- A connection system, the connector is insulated on
cation according to the standard EN 60522 the outside, whereas the entire connector of the
(IEC 60522)). V connection system is made of metal. When rout-
ing the cables of devices with the V connection
The chamber calibration factors must be entered
system, care must be taken to ensure that the con-
(refer to section 4.5). When replacing the chamber,
nectors and couplings do not come in contact with
do not forget to enter the new chamber calibration
metal parts of the X-ray equipment to prevent
factors (refer to section 7).
ground loops. For optimum immunity against elec-
trical interference, the DIAMENTOR M4-KDK
Ionization chambers calibrated by PTW-Freiburg
should only be grounded via the ground lead of the
are suitable for over-couch tubes and under-couch
power cord.
tubes. To compensate for the calibration error in-
herent in the system, a correction factor may be
entered (refer to section 4.4). The correction factor
for over-couch tubes is 1.10, for under-couch tubes,
0.95.
14 D428.131.00/08 en
DIAMENTOR M4-KDK
4.2 Wall mounting of the  Screw one fixation strap to each of the inserts,
DIAMENTOR M4-KDK using the enclosed screws (Figure 4-3).
The DIAMENTOR M4-KDK can be permanently

attached to the wall.
To attach the DIAMENTOR M4-KDK to the wall, the

rubber feet must be replaced with the screw inserts
supplied.
 Remove one rubber foot according to Figure 4-1

(squeeze plastic clip with a screwdriver).
Figure 4-3: Mounting the fixation straps
 Mount the DIAMENTOR M4-KDK to the wall.

Figure 4-1: Removing the rubber feet
 Mount the screw insert as shown in Figure 4-2.
Figure 4-2: Mounting the screw insert
 Replace the three remaining rubber feet in the

same manner.
D428.131.00/08 en 15
DIAMENTOR M4-KDK
4.3 Connecting the  The DIAMENTOR M4-KDK can be connected to

DIAMENTOR M4-KDK 230 V or 115 V power lines (50 to 60 Hz). If your
line voltage is 115 V, use only the "Hospital
Grade" cord which is provided with the instru-
CAUTION ment.
Shock Hazard - Always turn off the device be-
fore connecting or removing peripheral devices.
 For operation at 230 V in the United States or
Canada, the power supply cord must be a UL-
listed type SVT, with twist-lock attachment plug
rated at 250 V, 15 A. The twist lock attachment
WARNING plug is necessary to ensure grounding reliability.
For use with the DIAMENTOR M4-KDK, the
DIAMENTOR SD secondary display must have
firmware version 2.00 or higher.
The DIAMENTOR M4-KDK requires chambers of

the types listed in section 12. These chambers con-
sist of a chamber for measurement of the dose area
product (cable connector labeled "A") and the
chamber for measurement of the entrance dose
(cable connector labeled "B").
Figure 4-4: DIAMENTOR M4-KDK connectors
 Connect the chamber to inputs 8 (channel B)
and 10 (channel A) (Figure 4-4). Use only the 8 Chamber connection B
original PTW cables.
10 Chamber connection A
 Make sure that the chamber for measurement of 13 Power input
the dose area product is connected to the 16 Serial interface for connection of a printer or PC
chamber socket "A" of the DIAMENTOR M4- 17 2 connectors for secondary displays
KDK and the chamber for measurement of the
entrance dose is connected to the chamber
socket "B". Misconnecting the chambers will
lead to wrong measurement results.
 Connect the printer cable to the serial port 16

and the secondary display(s) to the display port
17.
 Connect the power cord to the power input 13.

Check that the power ratings are equivalent to
those indicated on the nameplate.
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DIAMENTOR M4-KDK
4.4 System Configuration (Setup Correction (Submenu):

Menu)  initiating the zero adjustment
4.4.1 Some Basic Facts  entry of the chamber temperature
 entry of the chamber ambient pressure

The setup menu is used to perform some basic
device adjustments. These settings are saved to  entry of the correction factor
the memory and will not be lost when the device is  entry of the focus chamber distance
switched off (refer to section 4.4.2). You can quit
the setup menu at any time without saving the ad- Printer (Submenu):
justments just made by pressing the RESET button.
 entry of the printer control commands
If you wish to save the new settings, use the PRINT
button to quit the menu. The setup menu includes Language
four submenus. The overview below shows the
contents of each of the menus. The operating steps  English, German, Spanish, Italian, French
are described on the following pages.
Dose area product Unit
 selecting the unit for dose area product meas-

CAUTION
urement: cGycm², µGym², Gycm²
Maloperation - The device does not accept im-
plausible entries. RS232
 printer, PC or unassigned
Display (Submenu): Print Mode

 selection of the display format (independently for  AUTO ON / OFF (initiate an automatic printout
the DIAMENTOR M4-KDK and the secondary with RESET: yes / no)
display)
 adjustment of the bar graph limits
 selection of the filter depth (filter depth from

0 to 9)
 activation of the display test
 enabling/disabling the time display
 selection of the display resolution (sensitivity

high / low)
Date & Time (Submenu):
 entry of date and time of day
D428.131.00/08 en 17
DIAMENTOR M4-KDK
4.4.2 Factory Settings Init code (section 4.4.15):

<000> <000> <000> <000>
The device is delivered with the following factory
Paper feed (section 4.4.15):
settings:
<009> <010> <000> <000>
Display format (section 4.4.5):
[D-d] [E-e] [D-d] [E-e] [D-d] [E-e] NOTE
Bar graph limits (section 4.4.6): This is the printer setup for the label printer
low = 0 and high = 3600 cGycm²/s STAR DP8340 L991096. This is also the default
setting even if the DIAMENTOR M4-KDK is de-
Filter depth (section 4.4.7): livered without a printer.
3
Time (section 4.4.8):

ON Language (section 4.4.4):
English
Display test (section 4.4.10):
N/A Dose area product unit (section 4.4.17):
µGym²
Date and Time (section 4.4.11):
Is set to the date & time in Germany RS 232 (section 4.4.18):
Computer
Zero adjustment (section 4.4.12):
N/A
NOTE
Chamber temperature (section 4.4.13):
If the DIAMENTOR M4-KDK is delivered with a
20°C
printer, this option is set to "Printer".
Air pressure (section 4.4.13):
1013 hPa Printmode (section 4.4.19):
Auto off
Correction factor (section 4.4.13):
1
18 D428.131.00/08 en
DIAMENTOR M4-KDK
4.4.3 Displaying the Setup Menu 4.4.5 Selecting the Display Format (Display
Submenu)
 Press  or  and, keeping either button de-
pressed, push ENTER to display the setup On the DIAMENTOR M4-KDK as well as on the
menu (Figure 4-5). (If you press the ENTER but- secondary displays the measured values can be
ton first, the DIAMENTOR M4-KDK changes to shown either on one line or on two lines. When only
the mode for entry of the chamber-patient dis- a single line is used, the bar graph expands accord-
tance). ingly. The following parameters can be selected
independently for display on the left side on each
line of the DIAMENTOR M4-KDK and the two sec-
ondary displays:
 [DFP] display of the dose area product
 [EFD] display of the entrance dose
 [dfp] display of the dose area product rate

Figure 4-5: Setup menu
 [efd] display of the entrance dose rate
 [D-d] automatic switching: display of the dose

4.4.4 Selecting the Language area product rate while radiation is
detected  display of the dose area
Before proceeding to further adjustments, you product if no radiation is detected.
should first select the language:
 [E-e] automatic switching: display of the
entrance dose rate if radiation is detected
 Using one of the cursor buttons, move the cur-
 display of the entrance dose if no
sor to "Language" and press ENTER.
radiation is detected.
 Select English, German, Spanish, Italian or  [ ] no measuring value
French and press ENTER.
From now on the texts are displayed in the selected

language and you can proceed to make further
adjustments. In order to save the language selec-
tion, however, you must exit the setup menu with
PRINT.
D428.131.00/08 en 19
DIAMENTOR M4-KDK
The Display submenu will be shown (refer to Fig-  Using the cursor button , select "Display" and
ure 4-6). press ENTER.
In the first square brackets to the right of "Display"

you choose the measuring value to display in the
first line of the DIAMENTOR M4-KDK, in the sec-
ond square brackets you choose the value for the
second line of the DIAMENTOR M4-KDK.
If you choose [ ] (= no measuring value) for the

second display line, you get a full-size bar graph.
The measuring values selectable in the third up to

the sixth square brackets are used for the configu-
ration of the secondary displays DIAMENTOR SD.
For options [DFP], [dfp] and [D-d], the dose area Figure 4-6: Display submenu
product or the dose area product rate, respectively,
is displayed in the display area to the left. In the 1 Parameter for 1st line on DIAMENTOR display
display area to the right you will see the measuring 2 Parameter for 2nd line on DIAMENTOR display
value for the fluoroscopy time. The line is labeled
3 Parameter for 1st line on secondary display 1
with a "D:" in the left margin of the
4 Parameter for 2nd line on secondary display 1
DIAMENTOR M4-KDK but it is labeled with an "A:"
on the display of the DIAMENTOR SD. 5 Parameter for 1st line on secondary display 2
6 Parameter for 2nd line on secondary display 2
For options [EFD], [efd] and [E-e], the measuring
value for the entrance dose or the entrance dose
rate, respectively, is displayed in the display area to
the left. In the display area to the right you will see
the current chamber-patient distance. The line is
labeled with an "E:" in the left margin.
20 D428.131.00/08 en
DIAMENTOR M4-KDK
The six pairs of brackets to the right of "Display"

represent the 6 lines to choose from (Figure 4-6).
 Press ENTER (the cursor starts flashing on the

first bracket), then press one of the cursor but-
tons repeatedly until you reach the correct pa-
rameter.
[DFP] display of the dose area product
[EFD] display of the entrance dose
[dfp] display of the dose area product rate
[efd] display of the entrance dose rate

Figure 4-7: Example of display format
[D-d] automatic switching: display of the dose area
product rate while radiation is detected 1 Measuring unit for the first line (display area to
 display of the dose area product if no the left)
radiation is detected. 2 Measuring unit for the second line (display area
to the left)
[E-e] automatic switching: display of the entrance
3 Measuring unit for the first line (display area to
dose rate if radiation is detected
the right)
 display of the entrance dose if no radiation
is detected. 4 Measuring unit for the second line (display area
to the right)
[ ] no measuring value 5 Fluoroscopy time
6 Chamber-patient distance
 Press ENTER to move to the next bracket.
7 Bar graph for the dose area product rate
 Proceed in the same manner for all other brack- 8 Entrance dose
ets. 9 Dose area product
 When finished, you can continue adjusting other

device settings, or you can quit the submenu
and the setup menu with RESET (selections will
be lost) or with PRINT (selections will be saved).
D428.131.00/08 en 21
DIAMENTOR M4-KDK
4.4.6 Bar Graph Limits (Display Submenu) 4.4.7 Filter Depth (Display Submenu)
The length of the bar graph corresponds to the The DIAMENTOR M4-KDK calculates the dose
dose area product rate. If the measured dose area area product rate on the basis of the change of the
product rate is below the low limit, the bar graph will dose area product over a period of time T between
not deflect. If the measured value reaches the high approx. 0.6 and 6 seconds. The time T automatical-
limit, the bar graph deflects to full scale. The bar ly adapts to the radiation pulse frequency of the X-
graph starts flashing when the dose area product ray device, allowing the dose area product rate to
rate exceeds the high limit. be indicated even in the presence of pulsed fluor-
oscopy.
The chain of dose area product rate values deter-

NOTE
mined in this manner are sent through a digital filter
The fact that the reading exceeds the high limit with adjustable filter depth for further smoothing
is indicated only by the bar graph flashing. before being displayed.
Major signal changes exceeding 12.5 % pass this

The bar graph scale is linear. Limits can be adjust- filter undelayed. Minor changes build up in depend-
ed in the range between 0.000 cGycm²/s and ence of the selected filter depth (possible setting
30,000 cGycm²/s from 0 to 9):
The following limitations must be observed: 0 =filter off T = 60 ms (fixed)

(max. - min.) > 1 cGycm²/s; min. > 0.8 max.
1 =filter on residual noise for pulsed fluoros-
 Call up the Display submenu. … copy approx. 9% / 1
 Using the cursor buttons, select "Bar graph lim- … copy approx. 9% / 5
its" and press ENTER. settling time to 90 %
approx. 5 x 2.3 x T
 Using the cursor buttons, adjust the first digit of
the low limit, or press ENTER to access the
copy approx. 9% / 9
second digit.
settling time to 90 %
approx. 9 x 2.3 x T
22 D428.131.00/08 en
DIAMENTOR M4-KDK
4.4.8 Time (Option) 4.4.9 Sensitivity (Display Submenu)
The fluoroscopy time determined by the You can choose between two sensitivity levels for
DIAMENTOR M4-KDK, both in continuous and the DIAMENTOR M4-KDK display:
pulsed mode, is equivalent to the difference in time
between beginning and end of the fluoroscopic  low sensitivity:
sequence. In the pulsed mode, the time includes The display resolution for the dose area product
the pauses, if these are shorter than 1.2 seconds. is fixed at 0.1 cGycm².
The maximum DAP value that can be displayed
If, in pulsed mode, pauses longer than 1.2 seconds is 99999.9 cGycm².
occur, the fluoroscopy time determined by the The display resolution for the dose area product
DIAMENTOR M4-KDK may not be identical with the rate is fixed at 0.1 cGycm²/s.
duration of the fluoroscopic sequence.
 high sensitivity:
For this reason, the fluoroscopy time readout can The display resolution for the DAP begins at
be disabled in the DIAMENTOR M4-KDK display 0.01 cGycm².
Setup menu. If the sum of the DAP values measured in both
channels reaches 9999.99 cGycm², the display
resolution changes to 1 cGycm².
With this resolution, the maximum DAP value
that can be displayed is 999999 cGycm².
The display resolution for the dose area product
rate is 0.01 cGycm²/s until the instantaneous
value of the added sum of the DAP rate values
measured in both channels exceeds
9999.99 cGycm²/s.
If the instantaneous value of the added sum of
the DAP rate measuring values exceeds
9999.99 cGycm²/s, the display resolution
changes to 1 cGycm²/s.
The same applies, when the display unit selected at

the DIAMENTOR M4-KDK is not cGycm².
The selected sensitivity is valid for the

DIAMENTOR M4-KDK display as well as for the
secondary displays DIAMENTOR SD which can be
connected.
The sensitivity does not affect the displayed en-

trance dose (rate).
D428.131.00/08 en 23
DIAMENTOR M4-KDK
4.4.10 Display Test (Display Submenu) 4.4.12 Zero Adjustment (Corrections Submenu)
With the display test option you initiate a perfor-

CAUTION
mance test of the digital display. The test ends au-
tomatically after approx. 40 seconds. Maloperation - If the system displays the mes-
sage "Offset current out of range. Confirm with
 Call up the Display submenu. PRINT!" at the end of the procedure, the sys-
tem could not be zeroed. Refer to section 6 for
 Using the cursor buttons, select "Display Test" information on possible causes and remedies.
and press ENTER.
High resolution of the charge is an important re-

4.4.11 Date & Time (Date & Time Submenu) quirement in the measurement of the entrance
dose. Consequently, inevitable leakage currents of
 In the setup menu, move the cursor to "Date & the chamber, chamber cable and amplifier have an
Time" and press ENTER. influence on the measuring result of the
DIAMENTOR M4-KDK. In order to obtain correct
The Date & Time submenu will be displayed. measurement results, the zero adjustment must be
performed with an unirradiated chamber and with
great care.
Fluctuations in the leakage currents of the

DIAMENTOR M4-KDK are particularly strong in the
first 15 minutes after turning the device on. There-
fore, you should allow for a warm-up period of at
Figure 4-8: Date & Time submenu least 15 minutes before performing the zero ad-
justment.
 Move the cursor to Date or Time and press
ENTER. If you need measuring values with very little leak-
age during a long-term measurement, it is recom-
 Using the cursor buttons, adjust the first digit of mended to repeat the zero adjustment after a
the date or the time and press ENTER. warm-up period of four hours and then leave the
DIAMENTOR M4-KDK turned on (overnight).
 Adjust the other digits in the same manner.
The zero adjustment should be repeated if the am-
The internal clock does not stop while the menu is bient temperature or humidity changes.
being displayed. The DIAMENTOR M4-KDK adopts
the new time as soon as you quit the menu with See section 10 for expected values for the drift of
PRINT. the display.
 In the setup menu, move the cursor to "Correc-

tions" and press ENTER.
24 D428.131.00/08 en
DIAMENTOR M4-KDK
The Corrections submenu will be displayed and the The air density correction factor is calculated by the
cursor flashes on "Zero instrument”. following formula:
P0  (t  273K)
KD 
P  (t 0  273K)
P0 = 1013 hPa
t0 = 20 °C
t = actual temperature
Figure 4-9: Corrections submenu P = actual air pressure
 Press ENTER to initiate the zero adjustment You can set only one correction factor for the
procedure. DIAMENTOR M4-KDK. As both measuring cham-
bers form a unit, the installation is the same for both
chambers (under-table tube or over-table tube).
Therefore, it would not make sense to set different
4.4.13 Chamber Temperature, Air Pressure and correction factors for the two chambers.
Correction Factors (Corrections Sub-
menu)
Before putting the DIAMENTOR M4-KDK into oper-

ation, the chamber temperature and air pressure for
air density correction must be specified. If there are
radiation absorbing parts between the patient and
the chamber (such as the patient couch), the corre-
sponding correction factor must be entered as well
(section 7).
 Display the Corrections submenu.
 Using the cursor buttons, select one of the menu

items and press ENTER.
 Using the cursor buttons again, adjust the first

digit and confirm it with ENTER.
 Proceed in the same manner to adjust all other

digits.
Adjustment ranges:
temperature (0 … 70) °C
air pressure (500 … 1 500) hPa
correction factor 0.000 … 9.999 (section 4.1)
D428.131.00/08 en 25
DIAMENTOR M4-KDK
4.4.14 Source-Chamber Distance
The DIAMENTOR M4-KDK calculates the value of

the entrance dose in the patient plane from the
value measured in the chamber plane.
The values are calculated according to the following

formula:
SCD 2
D Pat  D Cha
SCD  CPD2
DPat = Dose in patient plane
DCha = Dose in chamber plane
SCD = Source-chamber distance
CPD = Chamber-patient distance
The source-chamber distance depends on the

X-ray unit and the installation of the measuring
chamber. It must be set once during the installation
of the DIAMENTOR M4-KDK in the Corrections
submenu.
The chamber-patient distance may vary between

measurements. Therefore, the value is set immedi-
ately before a measurement (refer to section 5.2).
As the source-chamber distance directly affects the

measuring result, you should set the value as pre-
cise as possible to avoid errors.
26 D428.131.00/08 en
DIAMENTOR M4-KDK
4.4.15 Printer Control (Printer Submenu)
Via the printer submenu you can make all adjust-

ments required to control the printer.
The table below (Table 1) shows the adjustments

for the recommended printers.
 In the setup menu, move the cursor to "Printer"

and press ENTER.
The Printer submenu will be displayed.
Figure 4-10: Printer submenu
printer left Init code paper feed

margin
STAR DP8340 <0 2> <0 0 0><0 0 0><0 0 0><0 0 0> <0 0 9><0 1 0><0 0 0><0 0 0>
CITIZEN CT-S 281RSE- <0 1> <0 2 7> <0 3 3> <0 0 1> <0 0 0> <0 0 1> <0 1 2> <0 0 0> <0 0 0>
WH-PL without auto cut
CITIZEN CT-S 281RSE- <0 1> <0 2 7> <0 3 3> <0 0 1> <0 0 0> <0 0 1> <0 2 9> <0 0 0> <0 0 0>
WH-PL with auto cut
Table 1
D428.131.00/08 en 27
DIAMENTOR M4-KDK
4.4.16 Entering the Label Headline (Printer 4.4.18 RS232 Interface (Setup Menu)
Submenu)
A printer or a PC can be connected to the serial
 Display the printer submenu. port 16 (Figure 3-2).
 Move the cursor to "H" and press ENTER.  Display the Setup menu.
 Using the cursor buttons, select the first charac-  Move the cursor to "RS232" and press ENTER.
ter (numbers and letters) and press ENTER.
 Using the cursor buttons, select one of the
 Proceed in the same manner to select the other choices: "Printer", "Computer", " " (port not as-
characters. signed).
You may enter a headline of up to 36 characters.
4.4.19 Print Mode (Setup Menu)
4.4.17 Dose Area Product Unit (Setup Menu) You can select an AUTO PRINT mode in which the
DIAMENTOR M4-KDK will automatically document
Different radiological units for dose area product the measurement result when you delete it with
reading can be selected: Gycm², cGycm² and RESET (AUTO ON).
µGym².
 Display the Setup menu.
 Display the Setup menu.
 Move the cursor to "Print Mode" and press
 Move the cursor to "Dose Area Product Unit" ENTER.
and press ENTER.
 Using the cursor buttons, select one of the op-
 Using the cursor buttons, select one of the units. tions: “AUTO ON”/ “AUTO OFF”
NOTE
The unit of the entrance dose is always mGy,

irrespective of the unit set for the dose area
product.
28 D428.131.00/08 en
DIAMENTOR M4-KDK
4.5 Entering the Chamber  Check the chamber calibration factors.

Calibration Factors
If the factor needs to be corrected, proceed as fol-
When you put the DIAMENTOR M4-KDK into oper- lows:
ation for the first time, the chamber calibration fac-
 Move the cursor to the digit which is to be
tors must be entered. The unit of the chamber fac-
changed and press ENTER.
tor B is mGy/C. The DIAMENTOR M4-KDK accepts
calibration factors for channel B with a mantissa
 Using the cursor buttons, enter the first digit and
from 0.000 to 9.999 and an exponent from 8 to 12.
press ENTER.
For normal use of the DIAMENTOR M4-KDK the
exponent should be set to 9. The other values are  Proceed in the same manner to enter all other
reserved for tests and special applications. You can digits.
find the chamber calibration factors on the calibra-
tion data sheet. For further information on calibra-  Press PRINT to quit the menu.
tion, please refer to section 7.
 Holding the  button depressed, turn on the

DIAMENTOR M4-KDK.
The calibration menu will be displayed after approx.

7 seconds.
Figure 4-11: Calibration menu
D428.131.00/08 en 29
DIAMENTOR M4-KDK
Performing a Measurement
5 Performing a Measurement
5.1 Constancy Check NOTE
This test is meant to check the stability of the

CAUTION
electrical calibration. For this purpose a test
Erroneous Measurements - Run a functional charge is injected to the amplifier input (devia-
control every day before starting measure- tion ± 1 %) and the resulting gain is compared
ments. with the factory calibration.
The percentage deviation is indicated for each

channel. Deviations of ± 5 % are admissible
Check the device performance every day, before
(message: Test passed). When the deviation
putting the DIAMENTOR M4-KDK into operation.
exceeds ± 5 %, the message "Test failed" will
 Turn on the device and wait for the display to be displayed (confirm message with PRINT).
illuminate. In the second case, repeat the test. Should the
"Test failed" message be displayed again, the
 Press the TEST button 15 (Figure 5-1). DIAMENTOR M4-KDK must be repaired before
it can be used again.
Figure 5-1: Power switch 11 and TEST button 15
The test screen will be displayed (Figure 5-2). .

When no problem is found, the message "Test
passed" will be displayed briefly afterwards. The
test screen clears automatically after approx. 3
seconds.
Figure 5-2: Test screen
30 D428.131.00/08 en
DIAMENTOR M4-KDK
5.2 Measurement When the device has passed the test, the meas-
ured values will be shown in the selected format as
soon as radiation is detected.
Note on stabilization time

CAUTION
Erroneous Measurements! The device requires a minimum stabilization time of
15 minutes before a measurement can be per-
Auxiliary devices, such as filters, should always
formed, because the leakage is very high during
be inserted before the DIAMENTOR chamber
this time. As the leakage changes in the beginning,
and not between the DIAMENTOR chamber
it would not make sense to perform the zero ad-
and the patient.
justment within the first 15 minutes. The leakage
A filter or tubes placed between chamber and has a strong effect only on measurements with
patient will reduce the dose area product and small measuring values and long measuring times.
entrance dose relevant for the patient. Therefore, measurements with high values and
In this situation the DIAMENTOR M4-KDK will short times can be taken earlier. See section 4.4.12
display dose area product and entrance dose for further details.
values which are too high. Should the system
be permanently used with the filter or tubes, it is  Press PRINT to obtain a printout of the meas-
recommended to recalibrate the ured value, if you have not selected the AUTO
DIAMENTOR M4-KDK. PRINT mode.
 Then, before performing the next measurement,

reset the display to zero with RESET.
CAUTION
Erroneous Measurements! Equipment Dam-

 If you are in the AUTO PRINT mode, the meas-
urement will be automatically documented when
age!
you press RESET.
Before each use, verify that the DIAMENTOR
measuring range corresponds to the diagnostic
procedure.
Before each measurement, reset the measured
value to zero.
NOTE
The device is immediately ready for measure- Figure 5-3: DIAMENTOR M4-KDK, PRINT and
ment of dose area product values in the normal RESET buttons
range (dose area product > 1 cGycm²). If small-
er dose area product values are to be meas-  Having performed all measurements, turn off the
ured, the device requires a stabilization time of DIAMENTOR M4-KDK.
15 minutes (section 10).
Press RESET before starting the first meas-

urement to bring the device into a defined initial
state.
D428.131.00/08 en 31
DIAMENTOR M4-KDK
Chamber-Patient Distance With ENTER, you confirm the new value and acti-
vate the digit to the left which now will be displayed
The DIAMENTOR M4-KDK calculates the value of in reverse video. When you have entered the cor-
the entrance dose in the patient plane from the rect value, press ENTER again to exit the entry
value measured in the chamber plane. mode and save the value.
The value is calculated according to the following Pressing RESET disables the entry mode for the
formula: chamber-patient distance. Changes are not saved;
the previous chamber-patient distance will be re-
SCD 2 tained.
D Pat  D Cha
SCD  CPD2
Pressing PRINT disables the entry mode for the
DPat = Dose in patient plane chamber-patient distance, but changes will be
DCha = Dose in chamber plane saved.
SCD = Source-chamber distance
CPD = Chamber-patient distance As the value of the chamber-patient distance direct-
ly influences the measuring result of the entrance
The source-chamber distance depends on the dose according to the above formula, the accuracy
X-ray unit and the installation of the measuring of the measuring result depends strongly on the
chamber. It must be set once during installation of accuracy of the chamber-patient distance.
the DIAMENTOR M4-KDK in the Corrections menu
(see section 4.4.14). The chamber-patient distance Should the chamber-patient distance vary consid-
may vary between measurements. Therefore, the erably during a measurement, it is recommended to
value is set immediately before a measurement. divide the measurement into several single meas-
urements if a very accurate measurement result is
The DIAMENTOR M4-KDK accepts chamber- needed. For each of these measurements you can
patient distances in the range of (0 … 199) cm. set the correct chamber-patient distance. Between
measurements you must reset the display to zero,
The entry mode for the chamber-patient distances and after the last measurement the results from the
enabled simply by pressing ENTER without chang- single measurements must be summed up manual-
ing to Setup menu. ly.
When you are in this mode, a digit of the chamber-

patient distance will be displayed in reverse video,
indicating that it can be changed. You change the
value with the  /  buttons.
32 D428.131.00/08 en
DIAMENTOR M4-KDK
Error Messages and Troubleshooting
6 Error Messages and Troubleshooting
Message Cause Remedy
OL Overload of the measuring range. Press RESET.

Chamber voltage Chamber voltage missing or too Disconnect both chambers from the device and
missing! Confirm with low, short circuit in the cable or press PRINT. When the message disappears, the
PRINT. chamber, lead break, fuse 9 cable or chambers are defective.
(Figure 3-2) or device defective. Check the high-voltage fuse. If the fuse is intact,
the DIAMENTOR M4-KDK is defective.
Rate exceeds maxi- Due to the dose area product rate Turn off X-ray unit and press PRINT; when the
mum. Confirm with or the entrance dose rate the max. message clears, the input current was too high.
PRINT. input current of amplifier A or B Disconnect both chambers from the device and
was reached. press PRINT. If the message clears, there is a
cable and/or chamber defect. If not, the device
must be repaired.
Offset current out of The offset current measured during Turn off X-ray unit, press PRINT and repeat the
range! Confirm with zeroing was too high. zero adjustment. When the message clears, zero-
PRINT. ing was performed in the presence of radiation.
Disconnect both chambers from the device and
press PRINT. If the message clears, there is a
cable and/or chamber defect.
If the message will be displayed during first use of
the device, dry the device and the chambers in a
drying oven at 40 °C. If this does not help, the de-
vice must be repaired.
Checksum error in Memory malfunction Press PRINT and verify all device settings. Do not
setup! Press PRINT forget to check the chamber calibration factors.
to continue with de-
fault setup.
Device electrically Memory malfunction, the device Turn device off and on again. When the message
decalibrated! Press has lost the calibration values. will be displayed again, repeat the electrical cali-
PRINT to continue bration.
with default calibra- Have the DIAMENTOR M4-KDK repaired.
tion factors!
Printer not available! A print command was sent, alt- Check all connections, the printer, printer cable
Confirm with PRINT. hough a printer is not connected. and the adjustments in the setup menu.
The printer cable is defective, there
are open connections, the printer
option is not selected in the setup
menu (RS232) or there are no
labels in the label printer.
D428.131.00/08 en 33
DIAMENTOR M4-KDK
Calibration
7 Calibration
Some Basic Facts on Chamber Calibration

WARNING
(PTW-Freiburg Calibration Laboratory)
Erroneous Measurements!
 For verification of the chamber calibration factor
The radiological and electrical calibration of the
only the DIAMENTOR chamber needs to be re-
DIAMENTOR has already been performed by
turned to the factory.
PTW-Freiburg.
Ensure that calibrations are verified and per-  In order to take into account the different ab-
formed only by specialized staff or in the PTW- sorption conditions of over-couch and under-
Freiburg calibration lab. couch tubes, an additional absorber equivalent
to 0.35 mm AI is placed between the X-ray tube
and the ionization chamber during the factory
Electrical Calibration calibration.
Therefore the measurement error of over-couch
The DIAMENTOR M4-KDK is electrically calibrated tube installations where there is no absorber be-
at the factory. You can verify the calibration as de- tween chamber and patient is up to - 9 %.
scribed in section 5.1. If the electrical calibration In conjunction with under-couch tubes the ab-
values are outside the admissible range, the device sorption of the patient couch situated between
must be returned to PTW-Freiburg for repair, as the the patient and the chamber is equivalent to 0.5
electrical calibration can only be corrected at the to 0.7 mm AI, which results in a measurement
factory. error of up to + 5 %.
 The chamber calibration factors are noted down

Radiological Calibration on the calibration certificate.
The chamber calibration can be verified on site or in  Enter the new chamber calibration factors as
the PTW calibration laboratory. PTW-Freiburg rec- described in section 4.5.
ommends having this calibration performed every
2 years by PTW-Freiburg.  For compensation of a measurement error
of - 9 % and + 5 %, respectively, correction fac-
tors can be entered. As described in section 4.4,
enter a correction factor of 1.10 for over-couch
tubes and of 0.95 for under-couch tubes.
34 D428.131.00/08 en
DIAMENTOR M4-KDK
Calibration
Verifying the Chamber Calibration in Conjunc-  Note down the dose area product reading of the
tion with the X-Ray System DIAMENTOR (DAPmeasured).
Specially trained staff will be able to perform the  Note down the entrance dose reading shown on
chamber calibration on site. the DIAMENTOR (Mmeasured).
The accessories/tools required for the measure-  Calculate the dose area product
ment are: DAPcalculated = Mreference x A,
where A is the field size.
 Diagnostic dosemeter with detector
(e.g., NOMEX dosemeter with R/F/D detector  Repeat the measurement three times, noting
from PTW) down the results.
 X-ray film 13 cm x 18 cm (for analog radiog-

raphy) Fluoroscopy (under-couch tube)
 Test object with radiation-absorbing grid for
fluoroscopy (e.g., NORMI RAD/FLU from PTW)  Place the test object without the detector on the
patient couch (front screen facing down).
 Check the electrical calibration as described in
section 5.1.  Start fluoroscopy and determine the field size
(A) in the plane of the test object by means of
 Measure the exact distance between the diag- the test object depicted on the monitor.
nostic dosemeter detector in its measuring posi-
tion and the DIAMENTOR chamber.  Fasten the detector of the diagnostic dosemeter
in the center of the field.
 Enter this distance in the DIAMENTOR M4-KDK
parameter set as the chamber-patient distance  Start another fluoroscopy for 30 seconds.
(refer to section 4.4.14).
 Note down the reading shown on the diagnostic
dosemeter (Mreference).
Radiography
 Note down the dose area product reading of the
 Adjust a field size of approx. 10 cm x 10 cm. DIAMENTOR (DAPmeasured).
 Make a radiograph (70 kV and 40 mAs).  Note down the entrance dose reading shown on
the DIAMENTOR (Mmeasured).
 For digital imaging:
Determine the exposed area, using computer  Calculate the dose area product
software. DAPcalculated = Mreference x A,
 For analog imaging:
Place the X-ray film on the patient couch and  Repeat the measurement three times, noting
make a radiograph. Develop the film (only down the results.
briefly to obtain sharp edges) and measure
the exact size of the area (A).
 Place the detector of the diagnostic dosemeter

in the center of the field and make a radiograph
with the same system settings (70 kV and
40 mAs).

dosemeter (Mreference).
D428.131.00/08 en 35
DIAMENTOR M4-KDK
Calibration
Fluoroscopy (over-couch tube) Calculating the New Chamber Calibration Factor
 Place the test object without the detector on the  Calculate the mean value of DAPcalculated.
patient couch (front screen facing up).
 Calculate the mean value of DAPmeasured.
 Start fluoroscopy and determine the field size in
the plane of the test object by means of the test  Calculate the new chamber factor Knew, using
object depicted on the screen. the mean values and the old chamber factor:
 Fasten the detector of the diagnostic dosemeter K new 

DAPcalculated
 K old
in the center of the field. DAPmeasured
 Start another fluoroscopy for 30 seconds.

Entrance Dose
dosemeter (Mreference).  Calculate the mean value of Mreference.
 Note down the dose area product reading of the  Calculate the mean value of Mmeasured.
DIAMENTOR (DAPmeasured).
 Calculate the new chamber calibration factor
 Note down the entrance dose reading shown on Knew using the mean values and the old chamber
the DIAMENTOR (Mmeasured). calibration factor:
 Calculate the dose area product K new 

Mreference
 K old
DAPcalculated = Mreference x A, Mmeasured
 Repeat the measurement three times, noting Saving the New Chamber Calibration Factor
down the results.
 Enter the new chamber calibration factor as
described in section 4.5.
36 D428.131.00/08 en
DIAMENTOR M4-KDK
Peripherals
8 Peripherals
8.1 Secondary Displays Secondary displays are independent display units

which permit the user to perform all operations re-
quired to conduct a measurement (RESET and
CAUTION
PRINT buttons). There are displays with and with-
Maloperation - When the display does not re- out backlighting. A cable with a max. length of 40 m
ceive a signal, the message "No connection" (130 ft.) connects the secondary display to the
will be displayed. The same message is shown DIAMENTOR M4-KDK. Only the original PTW ca-
when the DIAMENTOR M4-KDK is in the setup bles, should be used. One or two secondary dis-
menu. plays can be connected to the
DIAMENTOR M4-KDK (Figure 4-4, port 17).
The display format can be selected separately for

NOTE each of the secondary displays (refer to sec-
Secondary displays with firmware version 2.00 tion 4.4.5).
or higher can be used with the
DIAMENTOR M4-KDK. Figure 8-1 shows the secondary display with back-
lighting.
The DIAMENTOR SD shows the letter A: in
front of the dose area product reading while the
DIAMENTOR M4-KDK shows the letter D: (refer
to Figure 4-7).
The identification of display 1 and 2 is encoded
in the display unit, it is independent of the con-
nector used (section 13).
D428.131.00/08 en 37
DIAMENTOR M4-KDK
Peripherals
Figure 8-1: Secondary display with backlighting
20 RESET button
21 Contrast adjustment ◑
22 Remote control sensor
23 Brightness adjustment (on backlit displays only) ☼
24 PRINT button
38 D428.131.00/08 en
DIAMENTOR M4-KDK
Peripherals
8.2 Printers The DIAMENTOR M4-KDK may be set to the

AUTO PRINT mode. In this case a test report is
automatically printed when the RESET button is
CAUTION
pressed (section 4.4.19).
Shock Hazard - Strictly observe the following Otherwise the PRINT button must be pressed to
warning. Failure to do so may endanger the obtain a printout.
lives of the patient, the users and other persons
involved. A label-print of the DIAMENTOR M4-KDK contains
the following information:
The DIAMENTOR M4-KDK and/or the second-
ary displays may be operated in the patient en-  label headline (a text of up to 36 characters can
vironment only if the connected printer fulfills be entered, refer to section 0)
the requirements of the EN 60950-1
(IEC 60950-1) / UL 60950-1 standard.  time
The connected printer fulfills the EN 60950-1  date
(IEC 60950-1) / UL 60950-1 requirements, if
 DAP: dose area product
used with the original power supply unit.
 time of fluoroscopy/radiography in minutes: sec-
The connected printer may be operated in the
onds
patient environment, only if it complies with the
EN 60601-1 (IEC 60601-1) /  EFD: entrance dose in the patient plane
ANSI/AAMI ES 60601-1 /
 DAP/EFD: quotient of the dose area product and
CAN/CSA-C22.2.No.60601-1 standard.
the entrance dose in the patient plane. Corre-
sponds to the irradiated plane in the patient
plane (assuming that the chamber-patient dis-
CAUTION tance did not change during the measurement).
Equipment Damage – Please read the printer  CPD: chamber-patient distance in cm

manual before putting the printer into service.
NOTE
Because the DIAMENTOR M4-KDK initializes

the connected printer after power-up, the printer
must be turned on before or at the same time
as the DIAMENTOR M4-KDK.
A test report can be printed via a label printer con- Figure 8-2: Sample printout
nected to the DIAMENTOR M4-KDK (Figure 4-4,
port 16). Check that the printer control submenu For insertion of the label roll and ink ribbon, please
(section 4.4.15) supports the connected printer. refer to the user manual of the respective printer
Other label printers can be connected as well. For model.
these, however, the adjustments in the printer con-
trol menu must be set as described in the respec-
tive printer manual.
D428.131.00/08 en 39
DIAMENTOR M4-KDK
Peripherals
8.3 PC
WARNING
Shock Hazard - The DIAMENTOR M4-KDK

and/or the secondary displays may be operated
in the patient environment only if the connected
PC fulfills the requirements of the EN 60950-1
(IEC 60950-1) (UL 60950-1) standard.
The connected PC may be operated in the pa-

tient environment, only if it complies with the
EN 60601-1 (IEC 60601-1) /
ANSI/AAMI ES 60601-1,
CAN/CSA C22.2.No.60601-1 standard.
The serial port (Figure 4-4, port 16) can also be

used to connect a PC to the DIAMENTOR M4-KDK.
Before connecting a PC via RS232 interface, set
setup menu RS232 to “Computer“ (refer to sec-
tion 4.4.18).
When connecting a PC to the

DIAMENTOR M4-KDK, please pay close attention
to the safety Information in section 2. A detailed
description of the interface is supplied on request
(order no. D428.131.1).
40 D428.131.00/08 en
DIAMENTOR M4-KDK
Cleaning, Preventive Maintenance and Disposal
9 Cleaning, Preventive Maintenance and Disposal
Surface
WARNING
Hazards to Persons! Equipment Damage!

CAUTION
Ensure that the service tasks described below
Equipment damage - Do not use disinfectants
are only performed by specialized staff.
on a phenol base or peroxide compounds to
In addition, ensure that all other service tasks disinfect the surface.
are only performed by PTW-Freiburg or by a
person authorized by PTW-Freiburg.
 First of all, disconnect the devices from the
power line, before attempting to clean or disin-
fect them.
9.1 Cleaning
 Rub the devices down with a moist cloth; no
Ionization chambers liquid must enter the devices. Due to the surface
geometry, a thorough disinfection is not possi-
The outer shell of the ionization chambers is made ble. The device cannot be sterilized.
of a plastic material called macrolon (polycar-
bonate). The electrode surfaces are made conduc- Connection Cables
tive by vacuum metallization. In this process a
transparent metal coating is applied to the elec-  Clean the cables as follows:
trode. In order to keep the coating transparent, ioni-
zation chambers must not be treated or come into  disconnect the cables from the devices, pull-
contact with alcohol or solvents. ing on the plug, not on the cable
 for cleaning, rub the cables down with a cloth

Cleaning agents and solvents contained in disin- moistened with soap water or with disinfect-
fectants (alcohols) have proved to be particularly ant
harmful.
 never immerse the cable in liquid!
 Wipe the chambers clean with a moist cloth.
 Please use a common disinfection agent for

medical instruments which is listed in your na-
tional hygiene institute (e.g. VAH in Germany). If
your country does not provide such a list we
recommend either an aldehyde based solution
or a solution with a quaternary ammonium com-
pound.
D428.131.00/08 en 41
DIAMENTOR M4-KDK
Cleaning, Preventive Maintenance and Disposal
9.2 Preventive Maintenance Technical Inspection of the Measuring System
In the following you will find a list of the mainte- The product must be inspected at regular intervals
nance measures and inspections necessary for the according to national regulations. It is recommend-
product. ed to perform the technical inspections of the
measuring system every 5 years at PTW-Freiburg
Check before each use or a qualified calibration laboratory.
 Before each use, visually inspect the device and Inspections must also be performed after repairs or
the cables for signs of mechanical damage. after each influence which may have changed the
behavior of the product.
 Also, conduct a constancy check as described in
section 5.1.
Calibration
 If damages or malfunctions are identified, the
device must be repaired before it is used again. Check the calibration regularly every 2 years as
described in section 7.
Repair The exact calibration factor and supplementary data

are included in the calibration certificate.
Repairs may only be carried out by PTW-Freiburg
or by persons / companies authorized by We recommend to have the DIAMENTOR M4-KDK
PTW-Freiburg. calibrated every 2 years at PTW-Freiburg or by
specially trained staff on site.
Safety inspections
9.3 Disposal of the Product
Only regularly inspected products are fail-safe. To
preserve the functional security and operational The typical lifetime of the DIAMENTOR M4-KDK is
safety, the safety inspections are to be executed at about 10 years
regular intervals according to national regulations.
At the end of the product life the
These inspections must only be performed by inde- DIAMENTOR M4-KDK components must be dis-
pendent persons with adequate training and experi- posed of in compliance with the applicable waste
ence. control regulations. The different materials must be
separated and recycled as appropriate.
It is recommended to execute the safety inspections
every 2 years. DIAMENTOR M4-KDK does not contain hazardous
materials.
The electronic components must be recycled ac-

cording to local regulations.
42 D428.131.00/08 en
DIAMENTOR M4-KDK
Technical Specifications
10 Technical Specifications
All specifications concerning entrance dose and  drift of indicated values:

entrance dose rate are only valid for a source- < 1 digit/h
chamber distance of 35 cm and a chamber-patient
 settling time:
distance of 50 cm.
120 ms
Device designation and use  nominal useful range dose area product rate:
DIAMENTOR M4-KDK T11017 and T11025 meas- 0.005 cGycm²/s to 30 000 cGycm²/s
uring device for the combined measurement of the irradiation time: 0.001 s … 999 min 59 s
dose area product according to EN 60580
Dose area product rate
(IEC 60580) and the entrance dose in diagnostic
radiology  selectable radiological units:
cGycm²/s, µGym²/s, Gycm²/s
Manufacturer PTW-Freiburg
 measuring range:
Number of measuring channels 1 0.1 cGycm²/s to 30 000 cGycm²/s
Measuring principle
 digital resolution:
detection of irradiation by means of ionization 0.01 cGycm²/s
chambers, analog and digital signal processing,
 accuracy: up to 10.0 µA <1% ± 1 digit
digital readout on LCD
up to 37.5 µA <1.5% ± 1 digit
Measuring quantities  linearity: up to 10.0 µA <1% ± 1 digit
 dose area product up to 37.5 µA <1.5% ± 1 digit
 dose area product rate  reproducibility:

< 1%
 entrance dose
 settling time:
 entrance dose rate
120 ms (depending on the selected filter depth,
 irradiation time section 4.4.7)
Dose area product Entrance dose

 selectable radiological units:  selectable radiological units:
cGycm², µGym², Gycm² mGy (fixed)
 measuring range:  measuring range:

6
0.1 cGycm² to 10 cGycm² 0.010 mGy … 10 Gy
 digital resolution:  digital resolution:

0.01 cGycm² 0.01 … 999.999 mGy: 0.001 mGy;
1 000 … 10 000 mGy: 1 mGy
 accuracy:
< 1% ± 1 digit, over the whole measuring range  accuracy:
< 2.5 % ± 1 digit
 linearity:
< 1% ± 1 digit, over the whole measuring range
 reproducibility:
< 1 % ± 1 digit, over the whole measuring range
D428.131.00/08 en 43
DIAMENTOR M4-KDK
 linearity:  nominal useful range of irradiated area on the

< 2.5 % ± 1 digit chamber:
(13x13 … 140x140) mm²
 drift of indicated values:
The central chamber must be fully in the beam.
< 1 digit/h (for constant temperature, stabiliza-
tion time > 15 minutes, after zero adjustment)
 reproducibility: Irradiation time

< 1 % ± 1 digit
 units of measurement:
 settling time: min, s
120 ms
 measuring range:
 nominal useful range of entrance dose rate: 1 s … 999 min 59 s
(0.0006 … 999.999) mGy/s
 digital resolution of the display:
 nominal useful range of radiation time: 1 second
1 ms … 999 min 59 s
 digital resolution, internal:
 nominal useful range of irradiated area on the 600 ms (entrance dose rate > 2.4 µGy/s)
chamber: 60 ms (entrance dose rate >12 µGy/s)
(13x13 … 140x140) mm²
 settling time:
The central chamber must be fully in the beam.
120 ms
Entrance dose rate  nominal useful range entrance dose rate:
 selectable radiological units: 2.4 µGy/s to 999.999 mGy/s
mGy/s (fixed)
 measuring range: Sampling rate 60 ms
(0.010 … 999.999) mGy/s Operational readiness 7 seconds after power up
 digital resolution: Stabilization time 15 minutes

0.001 mGy/s
Chamber voltage
 accuracy:
< 2.5 % ± 1 digit 400 V ± 2.5 %, fuse T32mAL, 250 V
 linearity: Current limitation of the chamber voltage

< 2.5 % ± 1 digit
< 0.5 mA
 leakage current:
< 0.001 mGy/s (for constant temperature, stabi- lonization chambers
lization time > 15 minutes, after zero adjustment)  type: 34044, 34049
 reproducibility:  connector: V, A
< 1 % ± 1 digit
Stability of the electrical control system
 settling time:
120 ms (depending on the detected filter depth, ±1%
section 4.4.7) Persistence of the non-volatile calibration factor
memory
typically 10 years
44 D428.131.00/08 en
DIAMENTOR M4-KDK
Power Environmental conditions

from the power line, design in EN 60601-1
Transport and storage
(IEC 60601-1) protection class l
 ambient temperature: (-20 … +60) °C
 rated voltage:
 rel. humidity: (10 … 85) %, no
switchable 230 VAC/115VAC 3
condensation (max. 20 g/m absolute humidity)
 operating voltage ranges:
 atmospheric pressure: (600 … 1 200) hPa
(196 … 253) V, (50 … 60) Hz and
(98 … 126.5) V, (50 … 60) Hz, respectively Operation
 rated current:  ambient temperature: (10 … 40) °C
230 V: 60 mA
 rel. humidity: (10 … 80) %, no
115 V: 120 mA
condensation (max. 20 g/m3 absolute humidity)
 fuses:
 atmospheric pressure: (700 ...1 060) hPa
230 V: 2x T125 mAH, 250 V
115 V: 2x T200 mAH, 250 V  max. operation altitude: 3 000 m a.s.l
Electromagnetic compatibility
Dimensions and weight
Suitable for use in an electromagnetic environment
according to EN 60601-1-2 (IEC 60601-1-2). DIAMENTOR M4-KDK
 width 225 mm (8.8 in.)

depth 198 mm (7.8 in.)
height 71 mm (2.7 in.)
weight 2.1 kg approx. (4.6 lb)
Secondary display
 width 200 mm (7.8 in.)

depth 55 mm (2.2 in.)
height 110 mm (4.3 in.)
weight 0.6 kg approx. (1.3 lb), with back-
lighting
0.5 kg approx. (1.1 lb), without
backlighting
D428.131.00/08 en 45
DIAMENTOR M4-KDK
Electromagnetic compatibility according to EN 60601-1-2 (IEC 60601-1-2)
11 Electromagnetic compatibility according to EN 60601-1-2

(IEC 60601-1-2)
The product "DIAMENTOR M4-KDK" fulfills the

following requirements of the EN 60601-1-2
(IEC 60601-1-2) standard.
WARNING
Magnetic and electrical fields are capable of in-

WARNING
terfering with the proper performance of the
Magnetic and electrical fields are capable of in- product
Product Failure!
product.
Do not use the product in the immediate vicinity
Product Failure!
or placed on top of or below other equipment.
Do not use cables longer than specified. This However, if the application requires an ar-
might impair the electromagnetic compatibility rangement of devices as described above, the
characteristics of the product. product should be monitored in order to ensure
its proper functioning in the specific arrange-
. ment.
WARNING
Magnetic and electrical fields are capable of in-

product.
Product Failure!
Maintain a minimum distance of 30 cm between
the product "DIAMENTOR M4-KDK" and porta-
ble RF communications equipment (including its
accessories such as antenna cables and exter-
nal antennas). Failure to observe this require-
ment may affect the performance characteristics
of the product.
46 D428.131.00/08 en
DIAMENTOR M4-KDK
Electromagnetic Emissions
Emissions test Compliance Electromagnetic environment – guidance

RF emissions EN 55011 Group 1 The product uses RF energy only for its internal
(IEC/CISPR 11) function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
RF emissions EN 55011 Class B The product is suitable for use in all establishments,
(IEC/CISPR 11) including domestic establishments and those directly
Harmonic emissions Class A connected to the public low-voltage power supply
EN 61000-3-2 (IEC 61000- network that supplies buildings used for domestic
1
3-2) purposes.
Voltage fluctuations/flicker Complies
emissions EN 61000-3-3
(IEC 61000-3-3)
1 The product fulfills the requirements of EN 55011 (IEC/CISPR 11) Class B. However, it is not intended for use
in domestic establishments.
D428.131.00/08 en 47
DIAMENTOR M4-KDK
Electromagnetic Immunity
Immunity tests Basic EMC Test level according to EN 60601-1-2 (IEC 60601-1-2)
standard
Electrostatic discharge EN 61000-4-2 ± 8 kV contact
(ESD) (IEC 61000-4-2)
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiated RF EM fields EN 61000-4-3 3 V/m
(IEC 61000-4-3) 80 MHz to 2.7 GHz, 80 % AM at 1 kHz
Proximity fields from RF EN 61000-4-3 27 V/m
wireless communications (IEC 61000-4-3) 385 MHz, pulse modulation 18 Hz
equipment 28 V/m
450 MHz, FM, ± 5 kHz deviation, 1 kHz sine
9 V/m
710, 745, 780 MHz, pulse modulation 217 Hz
28 V/m
9 V/m
28 V/m
2450 MHz, pulse modulation 217 Hz
9 V/m
Electrical fast transients / EN 61000-4-4 ± 2 kV power supply lines
bursts (IEC 61000-4-4) 100 kHz repetition frequency
± 1 kV input/output lines
100 kHz repetition frequency
Surges EN 61000-4-5 ± 0.5 kV, ± 1 kV line-to-line
(IEC 61000-4-5)
± 0.5 kV, ± 1 kV, ± 2 kV line-to-ground
Conducted disturbances EN 61000-4-6 3 Vrms
induced by RF fields (IEC 61000-4-6) 6 Vrms in ISM bands
150 kHz to 80 MHz, 80 % AM at 1 kHz
Rated power frequency EN 61000-4-8 30 A/m
magnetic fields (IEC 61000-4-8) 50 Hz and 60 Hz
Voltage dips, short inter- EN 61000-4-11 0 % UT for ½ cycle at 8 phase angles
ruptions and voltage varia- (IEC 61000-4-11)
0 % UT for 1 cycle at 0°
tions on power supply input
lines 70 % UT for 25/30 cycles at 0°
0 % UT for 250/300 cycles at 0°
48 D428.131.00/08 en
DIAMENTOR M4-KDK
Accessories and Spare Parts
12 Accessories and Spare Parts
Ordering information Ionization chambers
T11025 DIAMENTOR M4-KDK TA34044-1 DIAMENTOR chamber KDK

measures DAP and entrance dose, chamber with small central measuring
connecting system A. Includes LC field (13 x 13 mm) and large measur-
display, RS232 interface, power cable ing field. For use with DIAMENTOR
and wall fixation parts. For mains M4-KDK, with 2 signal outputs, con-
supply 115/230 V, 50-60 Hz. Cham- necting system A. Fixation parts re-
ber TA34044-1 required quired
T11017 DIAMENTOR M4-KDK TV34044-1 DIAMENTOR chamber KDK
measures DAP and entrance dose, combined chamber with small central
connecting system V. Includes LC (13 x 13) mm and large measuring
display, RS232 interface, power cable field. For use with DIAMENTOR M4-
and wall fixation parts. For mains KDK, with 2 signal outputs, connect-
supply 115/230 V, 50-60 Hz. Cham- ing system V. Fixation parts required
ber TV34044-1 required
T11011 DIAMENTOR SD, secondary display,
LCD with illumination Fixation elements
T11008 DIAMENTOR SD, secondary display,

T57523/U10 DIAMENTOR adaption rails 'S'
LCD w/o. illumination
T57523/U30 DIAMENTOR adaption rails 'P'
T25001-x Connection cable for secondary dis-
play
L991427 Thermal printer CITIZEN Ionization chamber connection elements
CT-S 281RSE-WH-PL
L502119 Thermo labels (role 50 x 30 mm) T26035-30 KDK cable set 'A30a', 30m, con-
necting system A
L991096 Label printer STAR DP8340
T26036-30 KDK cable set 'V30v', 30 m, con-
T25002-3 Connection cable for label printer
necting system V
STAR DP8340
L502035 Adhesive labels for STAR DP8340,
roll of 1000 labels Miscellaneous accessories
L991132 Power supply 110 – 250 V for label
printer STAR DP8340 D234.131.1 DIAMENTOR M4-KDK Interface
Description
The delivery overview is valid at the time of docu-

ment creation. The current list of accessories and
spare parts is available on request.
D428.131.00/08 en 49
DIAMENTOR M4-KDK
Special Adjustments
13 Special Adjustments
The adjustments described below must only be Selecting the line voltage
carried out by specially trained service technicians.
NOTE
Changing the secondary display from "Display
1" to "Display 2" The DIAMENTOR M4-KDK can be connected
to 230 V or 115 V power lines (50 to 60 Hz). lf
 Unscrew the four screws designated a in Fig- your line voltage is 115 V use only the "Hospital
ure 13-1 and remove the front panel. Grade Cord" which is provided with the instru-
ment.
 Unscrew the four screws designated b in Fig- For operation at 230 V in the United States or
ure 13-1 and remove the rear panel. Canada, the power supply cord must be a UL-
listed type SVT, with twist-lock attachment plug
 Jumper X2 connected (Figure 13-2): Display 1
rated at 250 V, 15 A. The twist-lock attachment
plug is necessary to ensure grounding reliabil-
 Jumper X2 disconnected: Display 2
ity.
 Remove the four plastic clips at the top of the

device (Figure 13-3).
Figure 13-1: Screws on secondary display Figure 13-3: Removing the plastic clips
 Remove the screws below.
 Open the housing.
 Set the voltage selector to the required value

(Figure 13-4).
 Close the housing.
Figure 13-2: Jumper X2 on PCB
50 D428.131.00/08 en
DIAMENTOR M4-KDK
Special Adjustments
 Exchange the fuse (refer to section 10) and

change the voltage rating on the device.
Figure 13-4: Line voltage selector
D428.131.00/08 en 51
DIAMENTOR M4-KDK
Literature
Literature [10] EN 61000-3-2 (IEC 61000-3-2)

Electromagnetic compatibility (EMC) - Part 3-2: Limits - Lim-
its for harmonic current emissions (equipment input current
[1] [Council Directive 93/42/EEC concerning medical devices ≤ 16 A per phase)
(Medical Device Directive - MDD)
[11] EN 61000-3-3 (IEC 61000-3-3) Electromagnetic compatibil-
[2] Council Directive 97/43/EURATOM on health protection of ity (EMC) - Part 3-3: Limits - Limitation of voltage changes,
individuals against the dangers of ionizing radiation in rela- voltage fluctuations and flicker in public low-voltage supply
tion to medical exposure systems, for equipment with rated current ≤ 16 A per phase
and not subject to conditional connection
[3] EN 60601-1-2 (IEC 60601-1-2)
Medical electrical equipment [12] EN 61000-4-2 (IEC 61000-4-2) Electromagnetic compatibil-
Part 1-2: General requirements for basic safety and essen- ity (EMC) - Part 4-2: Testing and measurement techniques -
tial performance - Electrostatic discharge immunity test
Collateral Standard: Electromagnetic compatibility - Re-
quirements and tests
ity (EMC) - Part 4-3: Testing and measurement techniques -
[4] EN 55011 (IEC/CISPR 11) Radiated, radio-frequency, electromagnetic field immunity
Industrial, scientific and medical (ISM) radio-frequency test
equipment - Radio disturbance characteristics - Limits and
methods of measurement.
[5] EN 60950-1 (IEC 60950-1) Electrical fast transient/burst immunity test
Information technology equipment - Safety
Part 1: General requirements
[6] EN 60601-1 (IEC 60601-1) Surge immunity test
Medical electrical equipment –
Part 1: General requirements for basic safety and essential
performance
Immunity to conducted disturbances, induced by radiofre-
[7] EN 60580 (IEC 60580) quency fields
Medical electrical equipment
Dose Area Product Meter
[8] EN 62353 (IEC 62353) Power frequency magnetic field immunity test
Medical electrical equipment –
[18] EN 61000-4-11 (IEC 61000-4-11) Electromagnetic compati-
Recurrent test and test after repair of medical electrical
bility (EMC) - Part 4-11: Testing and measurement tech-
equipment
niques -Voltage dips, short interruptions and voltage varia-
[9] EN 60522 (IEC 60522) tions immunity tests
Determination of the permanent filtration of X-ray tube as-
semblies
52 D428.131.00/08 en
DIAMENTOR M4-KDK
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 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
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 mainte-
nance 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 prod-
uct. 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 sepa-
rately 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/T11363-2006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。
D428.131.00/08 en 53
DIAMENTOR M4-KDK
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
Hazardous substances’ name

Component Name 有毒有害物质的名称
部件名称
(Pb) (Hg) (Cd) (Cr(VI)) (PBB) (PBDE)
（铅）（汞）（镉）（六价铬）（多溴联苯）（多溴二苯醚）
Display
X X X X X X
显示设备
Others
X O X X X X
其它
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。
54 D428.131.00/08 en
DIAMENTOR M4-KDK
Index
Index
A
Accessories and Spare Parts ........................................ 49
M
Adjustment of secondary display................................... 19 Measuring ...................................................................... 30
B O
Bar graph limits ............................................................. 22 Operating controls ......................................................... 12
Ordering information ...................................................... 49
C
Calibration ............................................................... 34, 42
P
Calibration factors ................................................... 29, 34 Peripherals .................................................................... 37
CE-mark .......................................................................... 2 Print mode selection ...................................................... 28
Chamber calibration factor ...................................... 29, 34 Printer control ................................................................ 28
Chamber-patient distance ............................................. 32 Printers .............................................................. 28, 33, 39
Chamber-patient distance, activate entry mode ........ 19, 32
Cleaning ........................................................................ 41
Configuration ................................................................. 17 R
Connecting the DIAMENTOR M4-KDK ......................... 16 Radiological calibration .................................................. 34
Constancy check ........................................................... 30 Repair ............................................................................ 42
RS232 interface........................................................ 28, 39
D
Date adjustment ............................................................ 24 S
Display formats ............................................................. 19 Safety information ............................................................ 6
Display test.................................................................... 24 Safety inspections.......................................................... 42
Disposal ........................................................................ 42 Secondary display ................................................... 37, 50
Dose area product, unit selection .................................. 28 Sensitivity levels ............................................................ 23
Sensitivity, select ........................................................... 23
E Service adjustments ...................................................... 50
Setup menu ................................................................... 19
Electrical calibration ...................................................... 34 Source-chamber distance .............................................. 26
Electromagnetic compatibility ........................................ 46 Stabilization time............................................................ 31
Error messages ............................................................. 33 Switching over the secondary display ............................ 50
F T
Factory settings ............................................................. 18 Technical Inspection of the Measuring System ............. 42
Filter depth .................................................................... 22 Technical specifications ................................................. 43
First-time operation ....................................................... 14 Time adjustment ............................................................ 24
G U
General information......................................................... 2 Unit selection ................................................................. 28
I W
Illustrations ...................................................................... 5 Wall attachment ............................................................. 15
Indicators....................................................................... 12 Warranty .......................................................................... 2
Intended use ................................................................... 6
Interface ........................................................................ 28
Ionization chamber ........................................................ 14 Z
Ionization chambers ................................................ 44, 49 Zero adjustment ............................................................. 24
L
Label headline ............................................................... 28
Language selection ....................................................... 19
Limit adjustment (Bar graph) ......................................... 22
Literature ....................................................................... 52
D428.131.00/08 en 55

DIAMENTOR M4KDK Manual

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DIAMENTOR M4KDK Manual

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User Manual

firmware version 2.10 or higher

 This manual is in conformity with the product

 PTW-Freiburg works in strict accordance with

2 For Your Safety 6

3 Operating Controls and Indicators 12

6 Error Messages and Troubleshooting 33

9 Cleaning, Preventive Maintenance and Disposal 41

11 Electromagnetic compatibility according to EN 60601-1-2 (IEC 60601-1-2) 46

12 Accessories and Spare Parts 49

Appendix: China Electronic Industry Standard Compliance 53

Figure 2-1: Definition of patient environment 10

1 Intended Use 2 For Your Safety

Indicates an imminent hazard. If not avoided,

The digital display can simultaneously show two of

A label printer can be connected (RS232 interface) NOTE

For use with the DIAMENTOR M4-KDK, the

WARNING Use of peripheral devices:

 The device is only intended to measure the

Equipment failure - Electromagnetic fields are Bodily Injury! Equipment Damage!

 The DIAMENTOR M4-KDK should not be

Equipment damage - Before connecting the

Equipment damage - Set up the device in a lo-

Please observe the user manuals of all con-

Set up the device so that the operator has a

Figure 2-1: Definition of patient environment

Do not position the device so that it is difficult to

Follow the user manual.

Please refer to user manual.

The product bears the CE-mark.

The product is certified by CSA

Manufacturer and date of manu-

Separate collection for electrical

3 Operating Controls and Indicators

Figure 3-1: DIAMENTOR M4-KDK, front view

Controls and indicator Symbol

Figure 3-2: DIAMENTOR M4-KDK, top view

Controls and indicator Symbol

4.1 Mounting the Ionization Assembly

CAUTION The DIAMENTOR M4-KDK connection cables are

 an inner conductor connected to the collector

 a second, concentric conductor connected to the

The DIAMENTOR M4-KDK can be permanently

To attach the DIAMENTOR M4-KDK to the wall, the

 Remove one rubber foot according to Figure 4-1

Figure 4-3: Mounting the fixation straps

 Mount the DIAMENTOR M4-KDK to the wall.

 Mount the screw insert as shown in Figure 4-2.

Figure 4-2: Mounting the screw insert

 Replace the three remaining rubber feet in the

4.3 Connecting the  The DIAMENTOR M4-KDK can be connected to

The DIAMENTOR M4-KDK requires chambers of

 Connect the printer cable to the serial port 16

 Connect the power cord to the power input 13.

4.4 System Configuration (Setup Correction (Submenu):

4.4.1 Some Basic Facts  entry of the chamber temperature

 entry of the chamber ambient pressure

 selecting the unit for dose area product meas-

Display (Submenu): Print Mode

 selection of the filter depth (filter depth from

 enabling/disabling the time display

 selection of the display resolution (sensitivity

Date & Time (Submenu):