Siemens Arcadis Varic Update Instructions

4.3 (3)

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

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

The original language of this document is German.

© Siemens AG 2006

 

 

 

All rights reserved

 

 

SP

 

 

 

 

 

 

 

Contact address

 

 

Siemens AG

Siemens AG, Medical Solutions

SPR2-310.620.01.03.02

Wittelsbacherplatz 2

Special Systems

Printed in Germany

D-80333 München

Henkestraße 127

AG 02/06

Germany

D-91052 Erlangen

 

 

 

Germany

 

 

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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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

 

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Operator Manual

ARCADIS Varic

Safety

SP

SPR2-310.620.01.03.02

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

SP

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

Printed in Germany

AG 02/06

Table of Contents

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

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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SPR2-310.620.01.03.02

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:

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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

IEC/TR 1289-2/08.94/

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 work should be performed by trained technical personnel only. maintenance 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 occupational 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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Safety

For the patient

For the operating personnel

For patients and operating personnel

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.

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.

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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Location and size of the relevant operating area

Vertical beam path. Focus 170 cm (height above floor)

Relevant operating area. Dimensions in cm.

(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

Heightabove

Measure-

Measure-

Measure-

Measure-

floor [cm]

ment A

ment B

ment C

ment D

 

[µGy/h]

[µGy/h]

[µGy/h]

[µGy/h]

 

 

 

 

 

10

529

85

37

4

 

 

 

 

 

20

616

94

42

4

 

 

 

 

 

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

 

 

 

 

 

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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Siemens Arcadis Varic Update Instructions

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

 

Operator Manual

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SPR2-310.620.01.03.02

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