Siemens MAGNETOM Avanto User manual

www.siemens.com/healthcare
MAGNETOM Avanto,
MAGNETOM Verio
Operator Manual – 4 Ch BI Breast / 16 Ch AI Breast
syngo MR E11

MAGNETOM Avanto,
MAGNETOM Verio
Operator Manual – 4 Ch BI Breast / 16 Ch AI Breast
syngo MR E11

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CAUTION
Used with the safety alert symbol, indicates a hazardous situation which, if not
avoided, could result in minor or moderate injury or material damage.
CAUTION consists of the following elements:
◾Information about the nature of a hazardous situation
◾Consequences of not avoiding a hazardous situation
◾Methods of avoiding a hazardous situation
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WARNING
Indicates a hazardous situation which, if not avoided, could result in death or
serious injury.
WARNING consists of the following elements:
◾Information about the nature of a hazardous situation
◾Consequences of not avoiding a hazardous situation
◾Methods of avoiding a hazardous situation
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1 Introduction 9
1.1 Product designations in this document 9
1.2 Information about branding 10
1.2.1 Siemens Healthineers 10
2 General safety information 11
2.1 Employee qualifications 11
2.2 Risks related to incorrect handling of the coil 12
3 Description 17
3.1 Overview 17
3.2 4 Ch BI Breast 18
3.3 16 Ch AI Breast 19
3.4 Breast biopsy device 20
3.4.1 Configuration 21
4 Breast imaging 25
4.1 Using the 4 Ch BI Breast 25
4.1.1 Preparing the frame 25
4.1.2 Positioning the coil 26
4.1.3 Positioning the female patient 27
4.1.4 Performing the measurement 27
4.2 Quality measurement 27
4.2.1 Quality measurement, head first 28
4.2.2 Quality measurement, feet first 28
4.3 Using the 16 Ch AI Breast 29
4.3.1 Preparing the frame 29
4.3.2 Positioning the coil 29
4.3.3 Positioning the female patient 31
4.3.4 Performing the measurement 31
4.4 Quality measurement 31
4.4.1 Quality measurement, head first 32
4.4.2 Quality measurement, feet first 32
5 Biopsy examination 35
5.1 Biopsy - general 35
5.1.1 Procedure 35
Table of contents
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5.2 Preparation 36
5.2.1 Preparing the biopsy device 36
5.2.2 Positioning the biopsy device 38
5.2.3 Positioning the female patient 39
5.2.4 Attaching the marker 40
5.3 Post/pillar method 41
5.3.1 Example: Wire localization 42
5.4 Grid method 51
5.4.1 Localizing the lesion 51
5.4.2 Determine the coordinates 52
5.4.3 Inserting the introducer sheath/stylet 52
6 Maintenance 53
6.1 Cleaning 53
6.1.1 Cleaning 54
6.1.2 Disinfection 54
6.1.3 Sterilization 54
7 Accessories 55
7.1 Biopsy accessories 55
7.2 Coil accessories 56
7.2.1 General positioning aids 56
7.2.2 16 Ch AI Breast 57
7.3 Accessories for quality assurance 57
8 Master copy 59
9 Appendix: Information about legal
manufacturer 63
9.1 Medical devices of other manufacturers 63
Index 65
Table of contents
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Introduction
This operator manual is an addendum to the operator manual MR
system.
This manual may include descriptions covering standard as well as
optional hardware and software. The description of an option does
not infer a legal requirement to provide it.
The graphics, figures, and medical images used in this operator
manual are examples only. The actual appearance and design of
these may be slightly different on your system.
References to “Siemens Service” include service personnel authorized
by Siemens.
All components of the complete operator manual may include
safety information that must be adhered to. The intended use of
the system is stated in the operator manual MR System.
Product designations in this document
In place of the printed product designations, the following
descriptions are used in this document:
Product Document/Text
4 Ch BI Breast 1,5T
4 Ch BI Breast 3T
4 Ch BI Breast
16 Ch AI Breast 1,5T
16 Ch AI Breast 3T
16 Ch AI Breast
1
1.1
Introduction 1
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Information about branding
Siemens Healthineers
Siemens has recently reorganized its organizational group structure.
The healthcare business now is a separate legal entity. This is
manifested in our new brand name:
While we have adopted this new brand name, the legal name of our
company and the name of the Legal Manufacturer do not change.
This change also does not impact any legal obligations. This new
brand name is reflected on newly created product labeling (for
example, user and technical manuals). Already existing material will
not bear the new brand name.
1.2
1.2.1
1 Introduction
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General safety
information
All safety information in the valid operator manuals must be
adhered to without fail. It is merely supplemented by the notes
contained in this document.
CAUTION
Accidental patient table movement!
Injury to the patient
◆If you plan an intervention outside the magnet, activate the
Table Stop button to avoid accidental patient table
movement, or injury to the patient. After completing the
intervention, the table can be unlocked.
Employee qualifications
WARNING
Improper handling of the biopsy device!
Incorrect diagnosis, bodily injury
◆Instruct your employees in the correct use of the biopsy
device, in particular in the setting of the positioning unit
based on offset data and in protocoling in the worksheet.
Follow the instructions in this manual, which explicitly explain
the procedures and possible hazards.
◆Train personnel with phantoms before using the biopsy
device on female patients.
2
2.1
General safety information 2
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
When moving the patient table, the coordinates computed for
the breast biopsy are deleted. However, it is still possible to print
out the worksheet.
◾Print out the worksheet directly after the offset coordinates are
generated.
◾Compare the data on the print-out with those on-screen. The
data have to match.
Risks related to incorrect handling of the coil
CAUTION
Damaged biopsy device!
Risk of injury
◆Prior to each use, check all components and individual parts
of the biopsy device for damage.
◆Use only undamaged components.
CAUTION
Breast implants!
Risk of rupture
Risk of damage caused by puncture
◆Use the greatest of care when performing biopsies on female
patients with breast implants.
If a previously enhanced lesion is not visible during the
examination using the breast biopsy device, perform a follow-up
examination the next day without applying compression.
2.2
2 General safety information
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CAUTION
Anatomy changed through biopsy!
Incorrect image selection/incorrect diagnosis
◆After completing the biopsy, do not reuse the old MR
reference images for additional examinations, create new MR
images instead.
CAUTION
Lesions/reference markers outside the magnet isocenter! Biopsy
software may fail to calculate biopsy data correctly due to
geometric image distortion caused by magnetic field
inhomogeneities.
Lesion is missed, incorrect diagnosis
◆Ensure that both marker and lesion are located as close as
possible to the magnet isocenter - possible axial expansions
are limited. If necessary, reposition the patient.
General safety information 2
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CAUTION
Inaccurate detection of the marker tip through unfavorable
selection of the slice location!
Incorrect diagnosis
◆Post/pillar method: to select the reference position, select
only slices that run parallel to the marker (medial/lateral:
transverse slices, cranio-caudal: sagittal slices).
◆Grid method: to select the reference position, select only
slices that run parallel to the grid (medial/lateral: sagittal
slices, cranio-caudal: transverse slices).
◆Measure the slices without slice distance and a slice thickness
< 2 mm.
◆Check the diameter and length of the marker for plausibility
and click the tip of the marker for computing the reference
position.
CAUTION
Diameter of the needle guide or needle block is too large!
Length of biopsy needle is too short!
Needle is incorrectly positioned
◆Use a needle guide (post/pillar method) or a needle block
(grid method) that corresponds to the diameter of the needle
thickness.
◆Use biopsy needles whose lengths correspond to the
calculated puncture depth.
2General safety information
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CAUTION
Puncture depth is read incorrectly!
Needle is incorrectly positioned
◆Take into account the length of the needle block.
◆Please consult the documentation provided by your biopsy
needle vendor regarding selecting the correct needle depth.
WARNING
Incorrect operation of the biopsy device! Carelessness while
inserting the needle!
Injury to the patient
◆When inserting the needle, take special care to avoid
penetrating the breast completely.
◆If you accidentally penetrate the breast completely and the
needle touches the opposite grid, do not pull back the needle.
This action might bend the distal needle end and could injure
the patient. Shorten the distal needle end with an MR Safe or
MR Conditional tool and remove the remaining introducer
sheath/stylet.
General safety information 2
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2 General safety information
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Description
Overview
Depending on the requirements, the products for breast
examinations can be used for biopsies or high-resolution breast
imaging.
They are of modular design and consist of various components.
4 Ch BI Breast
(1) Patient pad coil and insertion plate coil
(2) Biopsy device (post/pillar method)
(3) Frame
16 Ch AI Breast
(1) Coil
(2) Frame
3
3.1
Description 3
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Coil selection is a function of the type of examination to be applied.
For imaging during a biopsy examination, the 4 Ch BI Breast is used.
For high resolution breast imaging, the 16 Ch AI Breast is used. Both
coils consist of two parts that are positioned on or in the frame.
The biopsy device comprises different components. The configuration
varies depending on the examination method selected.
The frame is positioned on the patient table. It is used as a rack for
positioning the coil and biopsy device.
4 Ch BI Breast
The 4 Ch BI Breast is used for breast imaging. Depending on the
requirements, the coil may be used in the Head First or Feet First
orientation. The “Whole Body” option is required for examinations in
the Feet First orientation.
The 4 Ch BI Breast consists of two parts that are positioned on the
frame. ( Page 17 Overview)
(1) Patient pad coil (upper part of the coil)
(2) Insertion plate coil (lower part of the coil)
(3) Coil plug
3.2
3 Description
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This symbol is attached on the patient pad coil on the outside of the
loops: Please do not lean on these parts of the patient pad coil, to
avoid damage of the loops.
Do not bend the patient pad coil. Never carry the patient pad coil
by using the loops as handles! Do not pull at the coil loops to
release the patient pad coil from the patient rest. There is a risk
of damage to electronic components, and thus the total failure of
the 4 Ch BI Breast coil.
A description of the positioning aids is included in the accessory
chapter. ( Page 56 General positioning aids)
16 Ch AI Breast
The 16 Ch AI Breast is used for breast imaging. Depending on the
requirements of the examination, the coil may be used in the Head
First or Feet First orientation. The “Whole Body” option is required for
examinations in the Feet First orientation.
The 16 Ch AI Breast consists of two parts that are positioned in the
frame. ( Page 17 Overview)
3.3
Description 3
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(1) Fixed coil elements
(2) Coil plugs
(3) Release to disconnect the two coil parts
(4) Release to adjust the movable coil elements
(5) Center marking
(6) Opening for spectroscopy reference probe
(7) Symbol: Using the coil without frame forbidden
(8) Symbol: Using the coil with the frame only
A description of the positioning aids is included in the accessory
chapter. ( Page 56 General positioning aids)
Breast biopsy device
During a biopsy, the post/pillar and grid examination methods are
differentiated. Access for both methods is in the medial/lateral or
cranio-caudal direction.
The breast biopsy device is a mechanical configuration for stabilizing
the female breast. It may be used to prepare open biopsies as well as
for fully MR-guided percutaneous vacuum-assisted biopsies.
3.4
3 Description
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