Siemens Arcadis Varic Update Instructions
ARCADIS Varic
ARCADIS Varic
English
Operator Manual
SPR2-310.620.01.03.02
ARCADIS Varic
English
Operator Manual
SPR2-310.620.01.03.02
English
Operator Manual
SPR2-310.620.01.03.02
ARCADIS Varic
English
Operator Manual
SPR2-310.620.01.03.02
ARCADIS Varic
English
Operator Manual
SPR2-310.620.01.03.02
ARCADIS Varic
English
Operator Manual
SPR2-310.620.01.03.02
ARCADIS Varic
English
Operator Manual
SPR2-310.620.01.03.02
ARCADIS Varic
English
Operator Manual
SPR2-310.620.01.03.02
Operator Manual
ARCADIS Varic
VB 13 C
SP
© Siemens AG 2006
All rights reserved
The original language of this document is German.
Contact address
Siemens AG Siemens AG, Medical Solutions
Wittelsbacherplatz 2 Special Systems
D-80333 München Henkestraße 127
Germany D-91052 Erlangen
Germany
SP
SPR2-310.620.01.03.02
Printed in Germany
AG 02/06
ARCADIS Varic
Overall Table of Contents
Lists
Operator Manual
Overall Table of Contents
Register 1: Safety
General safety information..................................................................................................................... 3
Personal safety .................................................................................................................................... 16
Equipment safety................................................................................................................................. 24
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 .................................................................................................................. 35
Patient Browser configuration ............................................................................................................. 49
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 Varic
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 ........................................................................................................................................ 9
Labels .................................................................................................................................................. 13
Register 9: Maintenance
Functional and safety checks................................................................................................................. 3
Service support via network connection................................................................................................ 6
Cleaning and disinfection ....................................................................................................................... 9
Register 10: Accessories
Accessories............................................................................................................................................ 3
Cassette exposure ............................................................................................................................... 11
Operator Manual
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SiemensSP04Cs2
Operator Manual
ARCADIS Varic
Safety
SP
08.03
SPR2-310.620.01.03.02EnglishEnglish
, 7777SP MSVersion 04
Cs2
Please observe the
Safety register
This must be studied thoroughly before system startup.
The original version of this Operator Manual was written in the
German language.
© Siemens AG 2006
All rights reserved
Siemens AG, Wittelsbacherplatz 2, D-80333 München, Germany
Contact information: Siemens AG, Medical Solutions, Special Systems
Henkestraße 127, D-91052 Erlangen, Germany
Order no.: SPR2-310.620.01.03.02
SP
Printed in Germany
AG 02/06
General safety information
Information about this Operator Manual . . . . . . . . . . . . . . . . . . . . . . 3
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Information about correcting errors . . . . . . . . . . . . . . . . . . . . . 5
Names and parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Laws and regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Validity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Equipotential bonding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Electromagnetic compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Use in connection with high frequency . . . . . . . . . . . . . . . . . . . . . . . 8
Maintenance and check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Error messages at the C-arm system . . . . . . . . . . . . . . . . . . . . 10
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 . . . . . . . . . . . . . . . . . . . . . . . . 16
Crushing hazards on the C-arm system . . . . . . . . . . . . . . . . . . . . . 16
Crushing hazards on the monitor trolley . . . . . . . . . . . . . . . . . . . . . 18
Mechanical damage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Radiation protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Location and size of the relevant operating area . . . . . . . . . . . . . . 20
Maximum scatter radiation in the operating area . . . . . . . . . . . . . . 21
Radiation interruption for all operating modes . . . . . . . . . . . . . . . . 23
Equipment safety
Positioning the C-arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Installation, repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Original accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Combination with other products/components . . . . . . . . . . . . . . . . . . 25
Attachment of dedicated options . . . . . . . . . . . . . . . . . . . . . . . . . 26
General safety requirements . . . . . . . . . . . . . . . . . . . . . . . . . 26
Tilting resistance; mechanical strength; central ray migration . . . . . . . . 26
Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Attenuation equivalent . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Weight counterbalance . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Image quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Electromagnetic compatibility . . . . . . . . . . . . . . . . . . . . . . . . 27
Additional safety information . . . . . . . . . . . . . . . . . . . . . . . . 28
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
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Table of Contents
Operator Manual
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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 safety
❏ 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.
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Safety
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.
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.
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Safety
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.
In these paragraphs, the problem and the potential source of error is described.
◆ Perform these operating steps to solve the problem.
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.
Validity
This Operator Manual applies to the following product:
❏ ARCADIS Varic
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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 Varic 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 Varic system in a secure and load-adapted network.
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 or the relevant country-specific regulations.
Electromagnetic compatibility
This medical device complies with the requirements of the applicable standard on
electromagnetic compatibility (EMC).
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Safety
(→ 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
High frequency surgical equipment - Part 1: Operation
❏ IEC/TR 1289-2/08.94/
High frequency surgical equipment - Part 2: Maintenance
High frequency surgical equipment - Part 2: Maintenance
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Safety
Maintenance and check
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:
Pixel shift, image rotation, noise reduction, edge enhancement, subtraction,
Roadmapping.
Performing
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
Malfunctions
In the event of malfunctions of the ARCADIS Varic system, call SIEMENS
Customer Service.
Error messages at the C-arm system
When a malfunction is detected, the ARCADIS Varic 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 Varic is switched on.
❏ During routine operation, the ARCADIS Varic is continuously monitored.
❏ Temporary error messages, such as No. 5901, can be canceled by pressing
any button on the C-arm system (except lifting column and On/Off button).
❏ 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.
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 Varic 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 Varic 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
❏ delete 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 Varic can switch off.
In this case the ARCADIS Varic 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 Varic switches off completely.
When the power 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 the 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.
STOP
❏ Motorized vertical movement is then immediately disabled.
❏ 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 the event of fire
A fire or smoldering fire can produce toxic gases or fumes.
◆ Immediately switch off the ARCADIS Varic.
◆ 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 Varic 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 Varic 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,
❏ the temperature indicator on the control panel of the C-arm system lights up
❏ the selected characteristic curve is switched to S1 at the end of radiation in
fluoro and pulsed fluoro.
If the temperature rises to ≥ 60 °C,
❏ the selected characteristic curve is switched to S1 during radiation in fluoro
and pulsed fluoro.
If the temperature rises to ≥ 70 °C,
❏ the temperature indicator on the control console of the C-arm system flashes
❏ radiation is aborted and cannot be released again.
If the temperature drops back below 50 °C,
❏ the previously deselected curve is automatically reselected.
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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 system.
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 and 3).
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)
Rish 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)
(2)
(3)
(1) Potential danger points when moving and braking the C-arm
(2) Potential danger points when the C-arm is lowered fully
(3) Potential danger points when moving and braking the C-arm
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Safety
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.
Mechanical damage
To avoid injury to the patient, operating personnel or third parties, mechanical
damage to the system must be repaired by authorized service personnel.
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Radiation protection
Automatic dose rate control contributes considerably to the reduction of radiation
exposure of 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 (gonadal shield or
lead-rubber cover) when taking exposures in the vicinity of these organs.
Safety
For the operating
personnel
For patients and
operating 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 result in a higher radiation exposure.
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Safety
Location and size of the relevant operating area
Vertical beam path. Focus 170 cm (height above floor)
Relevant operating area. Dimensions in cm. (11)
(1) Tube
(2) I.I. housing
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Maximum scatter radiation in the operating area
Scatter radiation in the main operating area according to EN 60601-1-3
Safety
Height above
floor [cm]
10 529 85 37 4
2061694424
30 774 129 43 4
40 1051 145 49 5
50 1760 213 75 9
60 2970 342 118 15
70 4342 491 147 20
80 4687 588 201 26
90 6394 845 244 28
100 8370 1245 270 32
110 8960 1367 283 34
120 8586 1353 285 37
130 7938 1254 287 37
140 7150 1057 285 39
Measurement A
[µGy/h]
Measurement B
[µGy/h]
Measurement C
[µGy/h]
Measurement D
[µGy/h]
150 6232 765 284 37
160 5162 555 283 37
170 3604 397 288 39
180 2657 314 298 40
190 2030 257 298 40
200 1696 220 298 40
Tolerance of air kerma measurements ± 5 %
❏ Measurement A: Operating area A
Continuous fluoroscopy 110 kV, 2.9 mA, C-arm horizontal, downward beam
direction without additional Cu filter, with scatter radiation grid
❏ Measurement B: Operating area A
Characteristic HC2 high 68 kV, 1.3 mA, C-arm horizontal, downward beam
direction without additional Cu filter, with scatter radiation grid
❏ Measurement C: Operating area B
Continuous fluoroscopy 110 kV, 2.9 mA, C-arm horizontal, downward beam
direction without additional Cu filter, with scatter radiation grid
❏ Measurement D: Operating area B
Characteristic HC2 high 68 kV, 1.3 mA, C-arm horizontal, downward beam
direction without additional Cu filter, with scatter radiation grid
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Safety
cm above ground
µGy/h (power air kerma)
❏ Measurement A
Continuous fluoroscopy 110 kV, 3.0 mA
❏ Measurement B
Characteristic HC2 high, 68 kV, 1.3 mA
cm above ground
µGy/h (power air kerma)
❏ Measurement C
Continuous fluoroscopy 110 kV, 3.0 mA
❏ Measurement D
Characteristic HC2 high, 68 kV, 1.3 mA
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