Siemens AGSiemens AG, Medical Solutions
Wittelsbacherplatz 2Special Systems
D-80333 MuenchenHenkestraße 127
GermanyD-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
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
Curves and diagrams ............................................................................................................................. 3
Technical data ...................................................................................................................................... 15
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
WarningWarning 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.
CautionCaution 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
NoteNote 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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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 tearThe 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 qualityMaintenance 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:
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
ARCADIS Avantic
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Safety
Scattered radiation in the main operating area according to EN 60601-1-3
Height
above floor
[cm]
101,76041,92240,02160,9828
202,62442,35440,02161,0692
303,10683,14280,02161,116
403,50284,35240,03241,1232
504,61885,95080,03241,188
605,80327,59240,0541,2528
706,8589,14760,15121,2096
807,891211,1420,20521,1664
908,618413,61880,20521,0872
1008,287214,46120,19440,9288
1106,631210,13040,18360,7992
1205,947,45920,18360,7452
1304,70884,410,18360,72
1402,23561,37160,17280,6732
Measurement A1
[mGy/h]
Measurement A2
[mGy/h]
Measurement B1
[mGy/h]
Measurement B2
[mGy/h]
1500,98281,17720,17280,6048
1600,54720,83160,1620,54
1700,39960,56520,1620,4536
1800,33480,44280,15120,378
1900,28080,33480,14040,3132
2000,25920,270,12960,2592
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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