Siemens Arcadis Avantic Operator Manual

ARCADIS Avantic
ARCADIS Avantic
English
Operator Manual
SPR2-330.620.01.02.02
ARCADIS Avantic
English
Operator Manual
SPR2-330.620.01.02.02
English
Operator Manual
SPR2-330.620.01.02.02
ARCADIS Avantic
English
Operator Manual
SPR2-330.620.01.02.02
ARCADIS Avantic
English
Operator Manual
SPR2-330.620.01.02.02
ARCADIS Avantic
English
Operator Manual
SPR2-330.620.01.02.02
ARCADIS Avantic
English
Operator Manual
SPR2-330.620.01.02.02
ARCADIS Avantic
English
Operator Manual
SPR2-330.620.01.02.02
VB 13 C
SP
© Siemens AG 2006
All rights reserved
Contact address
Siemens AG Siemens AG, Medical Solutions Wittelsbacherplatz 2Special Systems D-80333 Muenchen Henkestraße 127 Germany D-91052 Erlangen
Germany
The original language of this document is English.
SPR2-330.620.01.02.02 Printed in Germany
AG 03/06
SP
ARCADIS Avantic
Overall Table of Contents
Register
System Operator Manual
Overall Table of Contents
Register 1: Safety
General safety information..................................................................................................................... 3
Personal safety .................................................................................................................................... 17
Equipment safety................................................................................................................................. 41
Register 2: System Description
Description of functions......................................................................................................................... 3
Operation ............................................................................................................................................... 9
Register 3: Patient Data
Introduction to patient registration......................................................................................................... 3
Emergency registration.......................................................................................................................... 5
Registering a new patient ...................................................................................................................... 9
Registering a known patient ................................................................................................................ 13
Patient registration configuration ......................................................................................................... 19
Introduction to the Patient Browser..................................................................................................... 25
Searching for and displaying patient data ............................................................................................ 29
Updating and deleting data .................................................................................................................. 37
Patient Browser Configuration ............................................................................................................. 51
Register 4: Examination
Safety information relating to the examination procedure ..................................................................... 3
The Examination task card ..................................................................................................................... 5
Performing an examination .................................................................................................................... 9
References task card ........................................................................................................................... 21
Displaying reference images................................................................................................................ 25
Native Task Card .................................................................................................................................. 29
Displaying native images ..................................................................................................................... 30
Reports ................................................................................................................................................ 33
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ARCADIS Avantic
Overall Table of Contents
Register 5: Viewing
Introduction............................................................................................................................................ 3
Loading and displaying images ............................................................................................................ 13
Scrolling and selecting images............................................................................................................. 19
Editing images ..................................................................................................................................... 33
2D Evaluation (option) .......................................................................................................................... 47
DSA Evaluation .................................................................................................................................... 57
Saving, transferring, documenting, closing images ............................................................................. 61
Viewing configuration .......................................................................................................................... 69
Register 6: Filming/Printing and Archiving
Introduction to filming/printing ............................................................................................................... 3
Automatic / manual filming .................................................................................................................... 9
Viewing and processing film sheets and images................................................................................. 17
Changing film settings for a film job .................................................................................................... 33
Controlling data transfer....................................................................................................................... 43
Configuration for filming/printing ......................................................................................................... 51
Introduction to archiving ...................................................................................................................... 63
Archiving data ...................................................................................................................................... 67
Exporting data ...................................................................................................................................... 71
Import/export in the file system........................................................................................................... 79
Controlling data transfer....................................................................................................................... 85
Configuration for archiving ................................................................................................................... 91
Register 7: Configuration
Examination configuration...................................................................................................................... 3
Register 8: Technical Description
Curves and diagrams ............................................................................................................................. 3
Technical data ...................................................................................................................................... 15
Labels .................................................................................................................................................. 19
Register 9: Maintenance
Functional and safety checks................................................................................................................. 3
Service support via network connection ................................................................................................ 6
Cleaning and disinfection ....................................................................................................................... 9
Register 10: Accessories and Options
Accessories............................................................................................................................................ 3
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SiemensSP04Cs2
Operator Manual
ARCADIS Avantic
Safety
SP
08.03
SPR2-330.620.01.02.02EnglishEnglish
Cs2
, 7777SP MSVersion 04
Please observe the
Safety register
This must be studied thoroughly before system startup.
The original version of this Operator Manual was written in the English language.
© Siemens AG 2006
All rights reserved
Siemens AG, Wittelsbacherplatz 2, D-80333 Muenchen, Germany Contact information: Siemens AG, Medical Solutions, Special Systems Henkestraße 127, D-91052 Erlangen, Germany
Order no.: SPR2-330.620.01.02.02
SP
Printed in Germany AG 03/06
General safety information
Information about this Operator Manual . . . . . . . . . . . . . . . . . . . . . . 3
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Information about correcting errors . . . . . . . . . . . . . . . . . . . . . 4
Names and parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Laws and regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Equipotential bonding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Electromagnetic compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Use in connection with high frequency . . . . . . . . . . . . . . . . . . . . . . . 7
Maintenance and check up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Error messages at the C-arm system . . . . . . . . . . . . . . . . . . . . 9
System messages on the monitor . . . . . . . . . . . . . . . . . . . . . . 11
Malfunction of electrics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Switching to emergency power supply . . . . . . . . . . . . . . . . . . . 12
Disconnecting the power supply plug . . . . . . . . . . . . . . . . . . . . 12
Emergency STOP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Fire protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Explosion protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Overload protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Table of Contents
Personal safety
Open heart and skull examinations . . . . . . . . . . . . . . . . . . . . . . . . 17
Crushing hazards on the C-arm system . . . . . . . . . . . . . . . . . . . . . 17
Crushing hazards on the monitor trolley . . . . . . . . . . . . . . . . . . . . . 19
Mechanical damage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Radiation protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Location and size of the relevant operating areas . . . . . . . . . . . . . . . . 21
X-ray tube assembly at the bottom . . . . . . . . . . . . . . . . . . . . . 21
X-ray tube assembly at the top . . . . . . . . . . . . . . . . . . . . . . . 25
X-ray tube assembly horizontal . . . . . . . . . . . . . . . . . . . . . . . 29
X-ray tube assembly lateral 45° . . . . . . . . . . . . . . . . . . . . . . . 33
Image intensifier lateral 42° . . . . . . . . . . . . . . . . . . . . . . . . . 37
Radiation interruption for all operating modes . . . . . . . . . . . . . . . . 40
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Table of Contents
Equipment safety
Positioning the C-arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Installation, repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Original accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Combination with other products/components . . . . . . . . . . . . . . . . . . 43
Attachment of dedicated options . . . . . . . . . . . . . . . . . . . . . . . . . 43
General safety requirements . . . . . . . . . . . . . . . . . . . . . . . . . 43
Tilting resistance; mechanical strength; central ray migration . . . . . . . . 43
Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Attenuation equivalent . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Weight counterbalance . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Image quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Electromagnetic compatibility . . . . . . . . . . . . . . . . . . . . . . . . 45
Additional safety information . . . . . . . . . . . . . . . . . . . . . . . . 45
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
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Safety
General safety information
Information about this Operator Manual
Proper use of this equipment presupposes that the operating personnel are familiar with the Operator Manual. This manual must be studied in detail prior to starting up the system. Special attention must be given to the following sections:
Safety information
Functional and safety checks
Personal s afety
Equipment safety
The operating personnel must be instructed in the proper operation of the equip­ment. Training must be repeated as required at appropriate intervals. We recommend simulating emergency conditions during training so that appro­priate corrective measures can be taught.
Warnings
Warning Warning is used to indicate the presence of a hazard which can cause personal
injury or death.
WARNING
At first the source of danger is stated.
Then possible consequences are pointed out.
In conclusion you receive information on how to rule out any danger.
Caution Caution is used to indicate the presence of a hazard which can cause damage to
the equipment if this is used improperly.
CAUTION
At first the source of danger is stated.
Then possible consequences are pointed out.
In conclusion you receive information on how to rule out any danger.
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Safety
General information
Note Note is used to notify users of operator information which is important but not
hazard-related.
Notes are marked with an exclamation mark “ !” and printed in italics.
Information about correcting errors
Information on how to solve problems that might occur when performing oper­ating steps is given at the end of the relevant instructions.
Names and parameters
All names and data of patients and institutions that are used in this operator manual are entirely fictional.
Any resemblance to names of existing people or institutions past or present is entirely coincidental.
All parameters and images shown in this manual are examples. Only the param­eters displayed by your system are definite.
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Safety
Laws and regulations
If legally binding regulations govern the installation and/or operation of the system, it is the responsibility of the installer and/or the operator to observe these regulations.
In all countries, the legally established regulations are to be observed. Deviating from this Operator Manual, values may be set according to country-specific regu­lations.
This product is provided with a CE marking in accordance with the provisions of Directive 93/42/EEC of June 14th, 1993 concerning medical devices.
Data related to individual persons are subject to data protection. Ensure compliance with all applicable laws and regulations.
Legally required tests must be performed at the specified intervals. These tests include, for example,
Constancy test according to the X-ray ordinance (§16 RöV) in the
Federal Republic of Germany.
Tests based on DHHS guidelines (Department of Health and Human Services)
where applicable.
Scope
This Operator Manual is valid for the following product:
ARCADIS Avantic
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Safety
Software
The system and user software used in this product is protected by copyright.
WARNING
Use of unreleased software or manipulations/modifications to released software can lead to system malfunctions.
This can result in injury to the patient and/or damage to the equipment!
Only software released by Siemens for use with this product may be used.
CAUTION
Impermissible or faulty manipulations/modifications to the software or to the connection between the ARCADIS Avantic system and the power supply can lead to malfunctioning of the system.
Unauthorized access!
Make sure all necessary precautions are taken (with the existing level of secu­rity) when changing a functionality or factory-set configuration.
CAUTION
Reduced system performance due to overload of the network environment.
Unexpected system behavior!
Only use the ARCADIS Avantic system in a secure and load-adapted network.
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46
Safety
Equipotential bonding
Products for which equipotential bonding is required may only be operated in medical facilities where supplementary equipotential bonding has been installed and tested according to DIN VDE 0107/10.94 section 4 or the relevant country­specific regulations.
Electromagnetic compatibility
This medical device complies with the requirements of the applicable standard on electromagnetic compatibility (EMC). (→ see Operator Manual “Information on electromagnetic compatibility”)
However, we wish to inform you that other mobile electronic devices such as radio telephones (mobile phones) exceed the radiation limits specified in the EMC standard and can therefore disturb functions of your medical device.
Use in connection with high frequency
The following regulations for use must be observed:
IEC/TR 1289-1 / 07.94/
High frequency surgical equipment - Part 1: Operation
IEC/TR 1289-2 /08.94/
High frequency surgical equipment - Part 2: Maintenance
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Safety
Maintenance and check up
Before using the equipment for examination, the user must ascertain that all safety-relevant devices function properly and that the system is ready for opera­tion.
Wear and tear The system is subject to mechanical and electrical wear and tear. In the interest
of the safety of patients, operating personnel and third persons, maintenance and safety checks must be carried out every 12 months to maintain the operational safety and reliability of the product.
Please observe the relevant information in the
(→
Register 9: Maintenance)
CAUTION
Mechanical damage and damage to the system electrics due to improper use and excessive load on the system.
Injury to operating personnel, patients or third persons and damage to the product!
If necessary, have the system checked more frequently.
Ensure that any defects are repaired professionally.
Image quality Maintenance should include checking the image quality. Maintenance at regular
intervals is recommended to always ensure best image quality.
To ensure optimal image quality, have the following functions checked in partic­ular as part of regular maintenance:
Pixelshift, image rotation, noise reduction, edge enhancement, subtraction, Roadmapping.
Performing mainte-
nance
Maintenance work should be performed by trained technical personnel only. If you do not have a maintenance contract, please contact Siemens Customer Service.
If national laws or regulations specify more frequent checking and/or mainte­nance, this must be observed.
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Safety
Failures
In the event of malfunctions of the ARCADIS Avantic system, call SIEMENS Customer Service.
Error messages at the C-arm system
When a malfunction is detected, the ARCADIS Avantic system is disabled. An error message is displayed on the control panel of the C-arm system:
In addition, a malfunction is also displayed on the left monitor:
All vital system functions are automatically checked each time the ARCADIS
Avantic is switched on.
During routine operation, the ARCADIS Avantic is continuously monitored.
Temporary error messages, such as No. 5901, can be canceled by pressing any
button on the C-arm system (except vertical up/down movements and C-arm brakes).
Non-temporary error messages, such as No. 5015 or 5016, cannot be
canceled. If these errors occur, radiation release is no longer possible. Please notify Customer Service immediately.
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Safety
Error messages 7309 (tube unit iris collimator) and 7409 (TV camera iris) are temporary error messages that can lead to unnecessary radiation exposure of the user and patient if treatment is continued.
If errors occur repeatedly, switch off the ARCADIS Avantic and notify Customer Service. Have the following information ready:
Error number
Operating mode selected
Was radiation activated when the error occurred?
Is the error related to an operating process?
In case of a malfunction or failure of the radiation indicator, please notify Siemens Customer Service.
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Safety
System messages on the monitor
Three different types of system messages can appear on the monitor. The type of message is identified by a corresponding symbol (top left).
Example of an error message:
Example of a warning:
Example of information:
You must confirm error messages with the OK button or the radiation release button to be able to resume your work. However, warnings and information do not disable radiation release.
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Safety
Malfunction of electrics
In case of danger for patients and operating personnel (e.g. if there is no live image on the monitor and the radiation indicator is on despite this) or danger for the product, you must disconnect the power plug immediately. The ARCADIS Avantic will be shut down completely and disconnected from the power supply. This will
switch off radiation
abort the current system program
abort and cancel current operating sequences
deleting all image information not saved to a hard disk.
Only after the cause of the hazard has been clearly identified and remedied may the system be reconnected to the power supply. In all other cases, e.g. system malfunction, contact Siemens Customer Service immediately.
Switching to emergency power supply
If a power interruption lasts longer than 8 ms, the ARCADIS Avantic can switch off. In this case the ARCADIS Avantic must be switched on again after switching to the emergency power supply.
In case of a power failure, a signal sounds (up to 10 min.) when the system switches to uninterruptible power supply (UPS).
Disconnecting the power supply plug
After disconnecting the power plug, voltage is supplied to the imaging system and the left monitor by the uninterruptible power supply (UPS) until the ARCADIS Avantic switches off completely.
When the plug is pulled out, switching to the uninterruptible power supply causes an acoustic signal to be emitted. The UPS switches off after 10 min. at the latest.
As soon as mains supply is restored, the battery of the UPS is recharged.
Please remember that the UPS battery life is limited.
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Safety
Emergency STOP
Please immediately press the red EMERGENCY STOP button (arrow) on the elec­tronics unit of the C-arm system when a dangerous situation results from moto­rized movements.
Motorized vertical movement is then disabled immediately.
All other system functions remain unaffected by this.
Unlock the button only after the danger has clearly been eliminated.
The button can be unlocked by gently turning it clockwise.
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Safety
Fire protection
WARNING
In case of fire
A fire or smoldering fire can produce toxic gases or fumes!
Immediately switch off the ARCADIS Avantic.
Pull the power cable out of the wall outlet.
Inform all personnel of the correct procedures in case of fire as part of occu-
pational safety training.
Please inform our Customer Service prior to starting up the ARCADIS Avantic again as it may require refurbishing due to damage caused by fire.
Explosion protection
WARNING
Ignitable concentration of anesthetic gases in the examination room.
Explosion hazard!
The ARCADIS Avantic must not be operated in such an environment.
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Safety
Overload protection
Prolonged continuous radiation at maximum tube load is permissible in fluoros­copy mode. However, this can cause the X-ray tube assembly to heat up. For this reason, the X-ray tube assembly has a thermal monitor. If necessary, power is reduced in all operating modes, in SUB/Roadmap with the next new scene/mask.
CAUTION
Heating up of the X-ray tube assembly due to continuous radiation
Burns of the skin may occur!
At a temperature of 50 °C the single-tank housing must not come into contact with the patient's skin.
The following operating states can occur:
If the temperature rises to 50°C or if a certain power limit of the X-ray tube is exceeded:
the temperature indicator on the control panel of the C-arm system lights up.
the LED on the key for high-contrast fluoroscopy flashes.
the imaging system displays a message in the status bar.
the system switches to characteristic SR1.
the previously set characteristic can be reselected for each new radiation
request by actuating the High Contrast key. On actuation of the key an acoustic alarm sounds (4- beeps).
all radiation for which the previously set characteristic was reselected is
counted.
If the temperature rises to 60°C or if a certain power limit of the X-ray tube is exceeded:
the temperature indicator on the control panel of the C-arm system flashes
continuously.
the LED on the key for high-contrast fluoroscopy flashes.
the imaging system displays a message in the status bar.
the system switches to characteristic SR2 and the maximum frame rate in the
PFC and DCM modes is reduced by one step.
the previously set characteristic can be reselected for each new radiation
request by actuating the High Contrast key. On actuation of the key an acoustic alarm sounds (4- beeps).
all radiation for which the previously set characteristic was reselected is
counted.
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Safety
If the temperature rises to 70°C or if the maximum power stage is exceeded:
radiation is aborted and cannot be released again.
the kV/mA display flashes no later than 30 s after radiation is disabled.
a message window is displayed on the imaging system.
If a third power limit value is exceeded at a temperature of < 70°C, radiation release is still possible. On actuation of the High Contrast key, you can switch over to characteristic SR1 for the next radiation cycle. This is indicated by an acoustic signal (8 beeps).
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Safety
Personal safety
Open heart and skull examinations
If an approved system is used alone or with other equipment for cardiac or cranial examinations, a conductive connection must be made between the system and a potential equalization point, e.g. the tabletop. (→ Register 2: System Description: page 10)
Only then may the patient be connected to the device.
Crushing hazards on the C-arm system
Correct handling of the C-arm system requires that operating personnel and patients use only the grips provided for this purpose. Where this is not possible, monitor the points of potential crush injury between movable system parts and their guide openings.
WARNING
Moving and braking the C-arm (see Fig. 1).
Risk of crushing hands!
Please make sure that your hands are not in the travel path of system parts.
WARNING
Maximum lowering of the C-arm (see Fig. 2)
Risk of crushing feet!
Please watch your feet when the C-arm is being lowered fully, since there may not be sufficient clearance left between the I.I. and the floor.
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Safety
WARNING
Maximum lowering of the C-arm (see Fig. 2)
Radiation can be released inadvertently!
Please make sure that the footswitch is not located underneath the C-arm.
The system areas marked in the drawings indicate points of crushing or impact hazards for the patient or operating personnel.
(1)
(1)
(1)
(2)
(1) Potential danger points when moving and braking the C-arm
(2) Potential danger points when the C-arm is lowered fully
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Crushing hazards on the monitor trolley
Your monitor trolley can optionally be equipped with a printer.
CAUTION
Moving the printer out or in
Risk of crushing hands!
Mind your hands when moving the printer out of or into its location.
Safety
Mechanical damage
To avoid injuries to the patient, operating personnel or third parties, mechanical damage to the system must be repaired by authorized service personnel.
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Safety
Radiation protection
Automatic dose rate control contributes considerably to the reduction of radiation exposure for the patient and the operator.
Nevertheless, observe the following important notes in order to keep the dose absorbed by the patient as low as possible.
For the patient Keep the radiation field as small as possible.
Provide the best possible protection for reproductive organs (gonad protective
caps or lead-rubber covers) during exposure in the vicinity of these organs.
For the operating
personnel
For patients and oper-
ating personnel
When releasing the exposure, the operator must keep a sufficient safety
distance from the X-ray tube assembly.
Wear protective clothing in the control area during an examination.
Wear a radiation-monitoring badge or use a pen dosimeter.
Keep the fluoroscopic time as short as possible.
Maintain the maximum possible source-skin distance.
Additional objects in the beam path may result in increased scattered radiation.
Please be aware that certain materials in the X-ray beam (e.g. parts of an oper­ating table) may impair the X-ray image due to imaging of contours and inclusions in these materials. In rare cases this can result in incorrect diagnosis. This material may also lead to higher radiation exposure.
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Safety
Location and size of the relevant operating areas
X-ray tube assembly at the bottom
94
1818
28
A
A
1
A
1
A
2
B
B
2
2
2
Fokus
Focal point
35
B
B
1
200
1
23
60
B
60
2
A
16
2
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Safety
Scattered radiation in the main operating area according to EN 60601-1-3
Height above floor [cm]
10 1,7604 1,9224 0,0216 0,9828
20 2,6244 2,3544 0,0216 1,0692
30 3,1068 3,1428 0,0216 1,116
40 3,5028 4,3524 0,0324 1,1232
50 4,6188 5,9508 0,0324 1,188
60 5,8032 7,5924 0,054 1,2528
70 6,858 9,1476 0,1512 1,2096
80 7,8912 11,142 0,2052 1,1664
90 8,6184 13,6188 0,2052 1,0872
100 8,2872 14,4612 0,1944 0,9288
110 6,6312 10,1304 0,1836 0,7992
120 5,94 7,4592 0,1836 0,7452
130 4,7088 4,41 0,1836 0,72
140 2,2356 1,3716 0,1728 0,6732
Measure­ment A1 [mGy/h]
Measure­ment A2 [mGy/h]
Measure­ment B1 [mGy/h]
Measure­ment B2 [mGy/h]
150 0,9828 1,1772 0,1728 0,6048
160 0,5472 0,8316 0,162 0,54
170 0,3996 0,5652 0,162 0,4536
180 0,3348 0,4428 0,1512 0,378
190 0,2808 0,3348 0,1404 0,3132
200 0,2592 0,27 0,1296 0,2592
Tolerance of air kerma measurements ±5%
Measurement A1: Operating area A1
continuous fluoroscopy 125 kV, 3.2 mA; C-arm vertical, X-ray tube assembly at the bottom, with scattered radiation grid
Measurement A2: Operating area A2
continuous fluoroscopy 125 kV, 3.2 mA; C-arm vertical, X-ray tube assembly at the bottom, with scattered radiation grid
Measurement B1: Operating area B1
continuous fluoroscopy 125 kV, 3.2 mA; C-arm vertical, X-ray tube assembly at the bottom, with scattered radiation grid
Measurement B2: Operating area B2
continuous fluoroscopy 125 kV, 3.2 mA; C-arm vertical, X-ray tube assembly at the bottom, with scattered radiation grid
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