NORAS Immobilization and Biopsy System MR-BI320-PA ...

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NORAS Immobilization and Biopsy System MR-BI320-PA ...

NORAS Immobilization and Biopsy System MR-BI320-PA

Immobilization and

Biopsy System MR-BI320-PA

for Immobilization and MRI-supported

Mammographic Biopsy with the NORAS

4 Channel PIC Breast Coil

System and PA320 Patient Rest

Operator‘s Manual

Revision 3.3

english

06/2009


MR-BI320-PA


Contents

1. General Information..................................................................5

2. Intended Purpose .....................................................................6

3. Operating Principle...................................................................7

4. Device Description ...................................................................9

4.1 Definitions and Symbols ................................................................ 9

4.2 System Components ...................................................................... 11

4.2.1 Patient Rest ......................................................................... 11

4.2.2 Coils..................................................................................... 11

4.2. Immobilization and Biopsy Devices ..................................... 12

4.2.4 Accessory: Biopsy Device cranio-caudal............................. 15

4.2.5 Accessory: Cranio-caudal Fixation Device .......................... 16

4.2.6 Combination with other Devices .......................................... 17

5. Start-up ......................................................................................19

5.1 General Information........................................................................ 19

5.2 Plug-in and unplugging Coils ........................................................ 21

5.3 Positioning of the Patient Rest...................................................... 23

5.3.1 Head first ............................................................................. 2

5.3.2 Feet first............................................................................... 24

5.4 Marker Filling Instructions ............................................................. 25

6. Localization and Biopsy Process............................................27

6.1.1 with Post&Pillar Positioning Device ..................................... 27

6.1.2 Application of the Post&Pillar adaptor for Ethicon Mammotome®

MR in combination with the Siemens - Syngo - Biopsy - Software... 4

6.1. Post&Pillar Adaptor for SenoRx Encor® ............................ 45

6.1.4 Post&Pillar Adaptor for Medinvents Coramate® ................. 45

6.1.5 Post&Pillar Adaptor for Atec® MRI Standard ..................... 45

6.1.6 Post&Pillar Adaptor for Bard Vacora® ................................. 45

6.2 Grid Fixation Plate .......................................................................... 46

6.2.1 Grid Needle Block Adaptor for Ethicon Mammotome® MR . 52

6.2.2 Grid Needle Block Adaptor for SenoRx Encor® ................. 52

6.2. Grid Needle Block Adaptor for Medinvents Coramate® ...... 52

6.2.4 Grid Needle Block Adaptor for Atec® MRI Standard .......... 52

MR-BI320-PA


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Contents

6.2.5 Grid Needle Block Adaptor for Bard Vacora®...................... 5

6.2 MRI Mammography......................................................................... 54

6.3 Safety Information........................................................................... 55

7. Cleaning, Disinfection and Sterilization .................................57

7.1 Cleaning........................................................................................... 57

7.2 Disinfection...................................................................................... 58

7.3 Sterilization...................................................................................... 60

8. Maintenance, Storage and Waste Disposal............................61

8.1 Maintenance .................................................................................... 61

8.2 Storage............................................................................................. 67

8.3 Waste Disposal................................................................................ 67

9. Technical Specifications ..........................................................69

9.1 Historical Device Data .................................................................... 69

9.2 Performance Data ........................................................................... 70

9.3 Parts List.......................................................................................... 71

9.4 Options and Accessories ............................................................... 73

10. Declaration of Conformity........................................................76

11. EC Declaration ..........................................................................77

12. Important Addresses................................................................78

13. Warranty Scope.........................................................................79

14. Training Certificate ...................................................................80

15. Warranty Registration ..............................................................81

MR-BI320-PA


1. General Information

General Information

To ensure safe and troublefree operation of this high quality medical device, please

carefully read and follow the instructions in this Operator’s Manual and pay particular

attention to the following information:

• The coil system, patient pad coil and insertion plate coil of the MR-BI320-PA can

be used with the following MRI systems:

1.5T Siemens 1.5T: Avanto, Espree, Sonata, Symphony

3T Siemens T: Tim Trio

FDA caution

Federal law restricts this device to sale, distribution and use by

or on the order of a physician.

• The Patient Rest with the Immobilization and Biopsy System is primarily

intended for use together with the NORAS Breast Coil System PIC - Pad Insertion

Coil (patient pad coil and insertion plate coil).

• The patient rest ist designed for patients with a weight up to 1 5 kg

• Prior to using this device for patient examinations, you should complete a training

with the device using a phantom! If a mammographic phantom is not available, you

may use a grapefruit or similar object to become familiar with the system.

• If you would like to receive up-to-date information about the further development of

or new accessories for your Patient Rest with Immobilization and Biopsy System,

please send an e-mail with the serial number of your coil to mri@noras.de.

• Assuming the total system is properly operated and handled, it can be used

for at least 5 years. After 5 years, a narrow inspection must be conducted by the

manufacturer. Due to the rapid technical developments being made in magnetic

resonance imaging, the practical usability of the total system must be assessed

from a mechanical point of view.

• You should inspect the needle block guides and adaptors at the latest after 2 years

to be sure they are in good condition and replace, if necessary.

MR-BI320-PA

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2 Intended Purpose

2. Intended Purpose

The intended use of the NORAS MR-BI320-PA is, in conjunction with a Magnetic

Resonance Scanner, the MR examination of the female breast. It is indicated for

use as a diagnostic imaging device to produce transverse, sagittal, coronal and

oblique images of the internal structures of the female breast. When interpreted

by a trained physician, these images provide information that can be useful in

determining diagnosis.

The included Breast Biopsy Unit BI160-2 permits MR guided breast biopsy and

wire localization of lesions can be performed by a trained physician.

Indications

Insertion Plate Coil

Biopsy Device

• Tumor recognition in the case of unclear diagnoses from other diagnostic

procedures using contrast agents and their decay times.

• Breast biopsy, viz biopsy from lateral, cranio-caudal and medial directions.

Contraindication

Patient Pad Coil

Patient Rest

All patient examinations are contraindicated with this system which are also

contraindicated in the proximity of the MRI device according to the information

provided by the manufacturer (e.g. breast implants, heart pacemakers, surgical

metallic implants or similar objects).

Furthermore, the responsibility lies with the examining physician in case of

unclear or critical clinical picture.

MR-BI320-PA


3. Operating Principle

Operating Principle

The 4-Channel Breast Coil System described in this document has been

designed, depending upon model type, for use with an MRI system with a field

strength of 1.5 T or T.

The coil system consists of pure receiving coils for the reception of high frequency

signals from the hydrogen -(¹-H) nuclei. The hydrogen nuclei are induced into

precession by the transmitting coil of the MRI device.

The precessing magnetization induces potential differences in the 4-Channel

Coil which are digitized and further processed in the MRI system.

The MR-BI320-PA consists of a Patient Rest with Immobilization, Biopsy

and Breast Coil System. Imaging is performed with a 4-channel “phased array”

coil (consisting of two coil pairs) developed and manufactured by the NORAS

Company. Two coils each are mounted in the patient pad coil and in the insertion

plate coil. Interconnection is handled by the software of the MRI.

The 4-channel mammographic coil is an innovative concept designed to offer

flexible use to meet the needs of the procedure to be performed in your clinic.

The upper 2-channel “Pad Coil” can be supplied as a 1.5 T or as a T model. (A

1 T model can be custom manufactured.). It is removable and enables the biopsy

device to be used with the respective corresponding coil with the different field

strengths. The 2-channel insertion plate coil in the lower area can be combined

for imaging with the upper 2-channel patient pad coil (1.5 or T). That way the

two devices form a high resolution, 4-channel “phased array” configuration.

By removing the no longer needed spine coil from the MRI table, more space can

be made available within the magnet opening.

In addition, thanks to the slightly tilted design of the patient rest, generous craniocaudal

access space is available for breast biopsies. Additional access space is

gained in the rear area for improved manual access by the user.

MR-BI320-PA

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The Immobilization Device can be rotated by 60°. This ensures optimum access

to the lesion (ca. 270°). For guidance, a telescopic assembly, the post and pillar

system, provides access also to regions very close to the chest wall (axilla). An

additional access possibility is offered by the alternative use of compression plates

and needle blocks. Biopsy access is single-sided medial, single-sided/double-sided

lateral or single-sided/double-sided cranio-caudal.

Safety Concept

Operating Principle

The following safety concept must be strictly followed while performing a biopsy.

A control scan must be made after each work step to verify the correct completion

of the previous work steps to be able to recognize incorrect adjustments of the

needle guides bases and needle blocks during the biopsy. That is the only way

incorrect adjustments, incorrectly read scale values and other operator errors can

be recognized in order to prevent injuries to the patient.

The control scan procedure is described in Chapter “Device Use”, in the description

of the biopsy procedure, and the correct result illustrated in the text.

MR-BI320-PA


4. Device Description

4.1 Definitions and Symbols

Device Description

The following symbols are used on the MR-BI320-PA Immobilization and Biopsy

System and in this manual:

Caution, read the accompanying documents.

Follow the instructions in the Operator`s Manual

Type BF

Protective Insulation

Temperature Limit

Not for household waste

S/N Serial Number

This product conforms with the essential requirements

of Council Directive /42/EEC of 14 June 1

concerning medical devices

Notice, immediate hazard for the device!

Caution, immediate hazard for persons!

Note Information regarding handling of the device

On the following page, we describe where you can find our various rating plates

on your product. In addition to the above-described symbols, you will also find

the model, product and serial numbers on these plates.

MR-BI320-PA

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4 Device Description

Rating Plates:

Immobilization Plate

The rating plate is located under the variable

position bar on the front right side.

Compression Plate

The rating plate is located on the upper right.

Positioning Device

The rating plate is located on

the right fixing block.

Patient Rest

The rating plate is located above the

opening of the insertion plate.

Patient Pad Coil

The rating plate is located

on the housing cover.

Insertion Plate Coil

The rating plate is located on the bottom

side of the insertion plate.

MR-BI320-PA


4.2 System Components

4.2.1 Patient Rest

Device Description 4

The patient rest is made of 100% fiberglass. The surface has been

finished with a two-component paint of gelcoat.

4.2.2 Coils

The insertion plate coil (IPC) is designed to enable insertion of the immobilization

and biopsy system and is inserted into the patient rest. The housing is made of

hard rigide plastic material.

Insertion Plate Coil (IPC)

The patient pad coil (PPC), which is made of PE foam with a PUR (skinfoam)

coating, serves as a positioning pad for the patient at the same time.

Patient Pad Coil (PPC)

MR-BI320-PA

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4

System Components

4.2.3 Immobilization and Biopsy Devices

Depending upon model, the following combinations are possible:

a) Biopsy Training Kit / Article No. 10185529 (Complete System)

Article No. MR10360-SI

The full version of the system consists of one base plate, two immobilization

plates, (for medial, lateral or craniocaudal use), one positioning system,

one compression plate, two slat lateral frames, one curved insertion plate

(horizontal), one Oil marker, one needle block each (12 G, 14 G, 1 G) and

one needle sleeve each (for needle sizes 1 G, 16 G, 1 G). All parts are

made of Teca PEEK.

It includes also one insertion breast plate and a store box.

The base plates can be rotated by 60° in 15° steps in the insertion plate

coil (usable access ca. 270°).

Device with Positioning Device

Pointer

Needle Sleeves

Compression Plates with Needle Blocks and Optional Marker Block

MR-BI320-PA


System Components

b) NORAS Biopsy Starter Kit with Grid Localization

Article No. MR10361

The grid version of the system consists of two base plates, four lateral/medial

immobilization plates, one compression plate, two slat lateral plates, two

horizontal curved slat lateral plates, and two needle blocks each (12 G, 14

G, 1 G). All parts are made of Teca PEEK.

The base plates can be rotated 60° in 15° steps in the insertion plate coil

(usable access ca. 270°).

The base plates can be rotated by 60° in 15° steps in the insertion plate

coil (usable access ca. 270°).

Compression Unit with Curved Insertion Plates

Compression Plate with Needle Blocks and Optional Marker Block

!!!NEW!!! - Can be ordered optional

Heigt adjustable NORAS Grid

0mm - 10mm

10mm - 20mm

20mm - 0mm

With the new height adjustable NORAS Grid you have 0mm more axial access

for the NORAS BI 20. Now it is possible to reach lesions with the grid, wich are

located near the axilla.

You have the possibility to decide between a disposable and a reusable height

adjustable Grid for both lateral and medial accesses.

Article No. MR10031-FL (reusable) MR10031-SL (disposable)

MR10031-FM (reusable) MR10031-SM (disposable)

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4 System Components

c) NORAS Biopsy Starter Kit with Post&Pillar PE320

Article Nr. MR10362

The post and pillar version of the system consists of two base plates, four lateral/

medial immobilization plates, one positioning device, two slat lateral plates, two horizontal

curved slat lateral plates, and two needle sleeves each (for 1 G, 16 G, 1

G needles) and a fiducial marker. All parts are made of Teca PEEK.

The base plates can be rotated 60° in 15° steps in the insertion plate coil (usable

access ca. 270°).

Consists of two base plates, four immobilization plates (for medial and lateral use),

two positioning devices, four slat lateral plates, two needle sleeves each (for 1 G, 16

G, 18 G needles), two curved insertion plates (horizontal) and two fiducial markers.

All parts are manufactured of Teca-PEEK.

The base plates can be rotated by 60° in 15° steps in the insertion plate coil (usable

access ca. 270°).

Device with Positioning Device

Pointer

Needle Sleeves

MR-BI320-PA


System Components

4.2.4 Accessory: Cranio-Caudal Biopsy Unit

Article Nr. MR10322-DC

To biopsy both breasts simultaneously with cranio-caudal access you will need the

cranio-caudal biopsy system developed by NORAS. This accessory is available

optionally at NORAS.

The cranio-caudal system consists of a special base plate, two immobilization

plates, two slat lateral plates horizontal, two slat lateral plates vertical, one positioning

device, two grids, a needle block set (for 12 G, 14 G, 1 G needles), a needle

sleeve set (for 13 G, 16 G, 18G needles) and a fiducial marker. The parts of the

cranio-caudal Biopsy Device are made of Teca PEEK and PET.s can be rotated by

60° in 15° steps in the insertion plate coil (usable access ca. 2t°).

MR-BI320-PA

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4 System Components

4.2.5 Accessory: Breast Immobilization System CC for PA320

Articla No. MR10063-CC-320

The MR1006 -CC- 20 is our cranio-caudal Fixation Unit, it enables immobilization

of one or even simultaneous immobilization of both breasts. It can be ordered as

accessories from NORAS MRI products GmbH.

The immobilization takes place inside the coil by fixation in cranio-caudal direction.

Both breasts can be fixed in one plain, so in the case of horizontal (axial) transversal

imaging they both can be pictured in less time via the layer reduction.

The device is composed of a special baseplate, two breast shells which are handled

via two grips and can be easily fixed with two fixation srews.

All parts are made of PC, POM and Teca-PEEK.

guidance rod left breast shell right breast shell

handle grip base plate fixation screw

MR-BI320-PA


4.2.6 Combination with other Devices

System Components

The coil system, patient pad coil and insertion plate coil of the MR-BI320-PA can

be used with the following MRI systems:

1.5T Siemens 1.5T: Avanto, Espree, Sonata, Symphony, Tim Symphony

3T Siemens T: Verio a TIM System, Trio a TIM System, Trio

Special NORAS adaptors are available for use with biopsy systems. The respective

adapters for the grid system must simply be inserted in the desired position of

the grid. Be sure that the adapters are firmly seated. With the help of the MRI

software, you can determine the correct gauge hole through which the needle

must be guided. To get information about our adaptors, see Datasheet „Adaptors

for Vacuum Guns“ on our homepage (www.noras.de) or send an e-mail to mri@

noras.de.

The post&pillar adaptors are attached to the guide base and can thus serve as

a needle guide.

The Mammotome® Biopsy System (Ethicon Endo-Surgerx Inc., FDA: K04275 )

can be used with a special adaptor. See Chapter “Device Use,” for more

information.

Additional adaptor systems can be custom-manufactured upon request.

Notice

The MR-BI320-PA System may only be used in combination

with the abovenamed devices and coils and accessories

supplied by the NORAS MRI products GmbH. The use of

accessories supplied by other manufacturers is only permitted

with the express written approval of NORAS MRI products

GmbH.

Bodily injuries due to accessories

Please follow the instructions of the accessories manufacturer.

Non-compliance with these instructions may lead to bodily

injuries of the user or patient.

MR-BI320-PA

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MR-BI320-PA


5. Start-up

5.1 General Information

Start-up

Device Damage/Coil Error

Only trained personnel may be assigned to handle the MR-

BI320-PA System.

Operating errors may cause permanent damages to the device/coil.

Bodily injuries

Only trained personnel may be assigned to handle the MR-

BI320-PA System.

Operationg errors may cause bodily injuries (e.g. contusions)

to the user and/or the patient.

Danger of Infection!

Prior to start-up of the devices or parts thereof, all components

must be treated as described in Chapter, Cleaning, Disinfection

and Sterilization.

Noncompliance with the above instructions may lead to infection

of the patient.

Notice

Please be sure to pay attention to and comply with the safety

information and instructions of the MRI device manufacturer

for operators, patients and third parties.

The Operator’s Manual must be read by each operator prior to using this device.

In order to become skilled in the proper handling of this system, you should, in

addition to participating in training with the system, use a phantom to become

familiar with its use.

MR-BI320-PA

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5 Start-up

Bodily Harm of the Patient!

Prior to each patient examination, you should make a careful

visual inspection of the system components.

In the case of unusual findings and/or damage found, the system

must not be used. Damaged parts can be sharp-edged

and cause injuries to the patient and/or to the user. Do not use

damaged coils. Do not produce images with a defective coil.

Push the insertion plate coil into the patient rest until it snaps into place.

Notice

Ensure that the insertion plate coil has been completely pushed

in and has snapped into place.

Assemble the desired configuration of the biopsy device. While pushing it onto

the immobilization plate, be sure the positioning system is pushed on as far as it

will go. You can check this by listening for an audible click.

Insert the biopsie device into the insertion opening provided. Ensure that the device

is firmly seated.

Position the patient rest with coils and the immobilization and biopsy device on

the MRI table.

Place the patient pad coil on the patient rest. In doing so, the amplifier covers

must be placed in the openings provided in the patient rest!

Notice

Firmly press the Velcro ® tape while positioning the patient pad

coil so that the pad cannot slip out of position.

Only use sterilized needle guides or needle blocks.

The shield trap must be aligned

as closely as possible parallel to t

he magnet opening and not

perpendicular to it.

Shield Trap

MR-BI320-PA


5.2 Plug-in and unplugging Coils

Start-up

Plug in both coil plugs into the connections provided on the MRI table.

1 2

1 2

1- : Plug for RX Connector Avanto

1- : Unplug RX Connector Avanto

Prolongation or Termination of the Treatment

While plugging in the coil pair, ensure and check that proper

contact has been made. Check the display of the MRI.

If the coil pair is not properly plugged in, no images can be

produced.

The MR-BI320-PA-System is recognized by the MRI software. The software operation

is described in the SIEMENS MRI operator’s manual.

MR-BI320-PA

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5 Start-up

Defective Coil!

To remove the plugs, only push on the plug-cover themselves,

do not pull on the plugs or on the cables!

Non-observance of this instruction may cause cracks in the

cable or in the plug. Defective coils (cables and plugs are part

of the coils!) must not be used!

Danger of destruction!

Pay attention to and comply with the cleaning and disinfection

instructions contained in this Operator’s Manual. Coils must

not be held under water!

Noncompliance with the instructions in Chapter “Cleaning,

Disinfection and Sterilization” of this Operator’s Manual may

destroy the coils.

Notice

Pay attention to the useful product lifetime (for safe use) of this

system. See page 5.

MR-BI320-PA


5.3 Positioning of the Patient Rest

5.3.1 Head first

Start-up

MR-BI320-PA

5

Position the system on the MRI table

and plug in the coil plug as shown in the

illustration on the left.

Plug

Position the system at the desired location

and place the wedge cushion on the

MRI table in such a way that the cable lie

in the cable guide of the cushion.

Recess for the cable

For more comfortable positioning, you

can place a foam roll under the patient’s

legs.

Optimum patient positioning.

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5 Start-up

5.3.2 Feet first

Position the system on the MRI table

and plug in the coil plug as shown in the

illustration on the left.

Plug

Position the system at the desired location

and place the wedge cushion on the

MRI table in such a way that the cable lie

in the cable guide of the cushion.

With MRI models with short table travel,

the light field lamp must be set between

S7 and S as shown below.

Or you can readjust the field of view.

The shield trap must be aligned as closely

as possible parallel to the axis of the magnet

bore and not be perpendicular to it.

For more comfortable positioning, you

can place a foam roll under the patient’s

legs.

MR-BI320-PA


5.4 Marker Filling Instructions

Opening Markers

You can open the oil marker or the cube marker by hand. To open the marker

cover in the grid, use a screwdriver with a blade width of .6 mm and to open the

cover of the cartridge marker, use a screwdriver with a blade width of 5,6 mm.

The cartridge marker can be released either

with a screwdriver or with a needle sleeve of

the unit.

Be sure to only use MRI-compatible screwdrivers. If no MRI-compatible screw-

drivers are available, then you must fill the oil markers outside of the MRI room!

Filling Markers

Start-up

We only sell unfilled oil markers. The number of oil markers required depends upon

the individual type of system used (One marker is needed for manual localization,

up to four markers are needed for software-supported localization). Please pay

attention to the following marker refilling:

Oil and cube marker bolt marker marker inside the grid cartridge marker

The markers must be filled with diluted MRI contrast agent to make them visible

in MRI. To do so, fill a syringe with contrast agent (diluted 1: 200) and then slowly

fill the marker with the syringe up to the edge of the marker thread starting at the

bottom of the marker. Rotate the syringe during filling to prevent the formation of

bubbles.

cube marker bolt marker marker inside the grid cartridge marker

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5 Start-up

Closing Markers

You can close the oil marker or the cube marker by hand.

To close the marker cover in the grid, use a screwdriver with a blade width of

.6 mm and to close the cover of the cartridge marker, use a screwdriver with

a blade width of 5.6 mm. Be sure to only use MRI-compatible screwdrivers. If

no MRI-compatible screwdrivers are available, then you must fill the oil markers

outside of the MRI room!

Test Measurement

Test marker imaging by installing the biopsy system and taking a test measurement.

The markers must be homogeneously imaged. They must not exhibit

any “holes” which are air bubbles. (which can also be recognized as a “kink”

in the marker).

If the marker cannot be imaged as a straight line, then change the phase code

direction during imaging and verify the changed settings.

Emptying Markers

Markers must be emptied prior to sterilization! To empty them, open the markers

as described above and empty them.

Health Hazard for Operator

Marker liquid is hazardous to health. See warning instructions.

Use a syringe (filled with distilled water) to rinse out the markers starting at the

bottom of the marker to remove any residual marker liquid. Then dry them or

open and place them in upright position within in the steam autoclave.

MR-BI320-PA


Permanent Damage to the System

The system may only be assembled by trained medical personnel.

Incorrect assembly and operator errors made by untrained

personnel can permanently damage individual parts of optional

components and of the device itself.

In the following, the localization process with mediolateral alignment of the immobilization

device, lateral access and the use of axial slices is described. This description

applies for the use of the system with the positioning device for the examination of

a single mamma.

Medial and Lateral Access:

Push the immobilization plate with medial slat lateral plate on to the shorter variable

position bars of the base plate as far as it will go. Then push the second immobilization

plate with the curved insertion plate on to the longer variable position bars of the base

plate also as far as it will go. Then put the base plate into the round recesses of the

insertion plate of the patient rest. Then align the complete immobilization device in the

mediolateral direction and push the immobilization plates to the end of the variable

position bars. The immobilization device is now open as far as possible. For medial

access, insert the cover plate into the patient rest of the side of the mamma which

is not to be biopsied. Now position the patient on the patient rest and immobilize the

mamma to be biopsied by pressing the slat lateral plates on the variable position bars

against the mamma. Be careful to ensure that the patient can lie as comfortably as

possible during the entire procedure. You now have medial access below the cover

plate or lateral access from the outside.

Cranial/Caudal Access:

Localization and Biopsy

Process

6. Localization and Biopsy Process

The biopsy procedure is based upon the safety concept described in Chapter

“Operating Principle.” Compliance with this concept is mandatory.

6.1.1 with Post&Pillar Positioning Device

To enable cranial/caudal access, proceed as described above to provide medial/lateral

access. Please note that when the biopsy device is turned into the craniocaudal

direction, the MRI images must be made in the sagital direction to correspond with

the following description. A double cranial biopsy device is available as an optional

accessory to enable simultaneous biopsy of both mammae.

MR-BI320-PA

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2

6

Localization and Biopsy

Process

Puncture at the wrong place

The mamma must be correctly immobilized. Please check this.

If the mamma is not immobilized properly, it might slip and the

data delivered by the MRI will be incorrect.

• Ensure that as much mamma tissue as possible is held between the slat lateral plates.

Infection of the patient

Place a sterile tissue on the insertion plate.

Not covering the Insertion plate coil with a sterile tissue may lead

to infection of the patient.

• Screw the filled marker into one of the needle guides (on right or left side) and reset

the scales of the guide base, guide bar and the angulation angle of the needle guide

of the positioning device to zero (both horizontal and vertical).

Marker in center

of device

Set angulation angle,

guide base and guide

bar to „0“ position.

• Now mount the positioning device onto the pins of the immobilization plate.

MR-BI320-PA


Localization and Biopsy

Process

• Detect the fiducial marker in the MRI using axial slices (see Ill. 1 and 2).

1

2

Firucial

Marker, right

1 st Slice

2 nd Slice

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6

Localization and Biopsy

Process

• Mark the marker with a permanent auxiliary line from the software toolbox of

your MRI device (Ill. ).

Linie auswählen

• Copy the auxiliary line as a reference line into all slices and/or into the slice in

which the lesion was detected (Ill. 4).

4

Draw auxiliary line

Copy and insert

reference line

MR-BI320-PA


Localization and Biopsy

Process

• Detect the lesion and determine the distances between marker and lesion (anterior-posterior)

with the help of the distance measurement tool (Ill. 5 and 6).

5

In the example shown, the lesion extends 1.77 cm from anterior to posterior.

MR-BI320-PA

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2

6

Localization and Biopsy

Process

6

Draw second line from the

lesion to the reference line.

• Determine the head first distance between marker and lesion using slice thickness

and slice number.

• Note the posterior/anterior or head first distances (considering the ± values).

Exampel: Slice of the Marker: 20

Slice of the lesion: 0

slice thickness 2 mm

0-20 = 10

10 x 2 mm = 20 mm (to the head)

Measure distance

MR-BI320-PA


Localization and Biopsy

Process

• Place the marker at the calculated position and run the table back into the MRI

device for a control measurement. The lesion must lie in the same plane as the

marker.

• The telescopic bar can be

released using the small locking

wheel on the rear side and be

shifted upward to provide

access to regions near the

thorax.

• Now measure the penetration depth (skin-lesion distance). Follow the instructions

of the respective manufacturer if using software for this purpose or if a vacuum

stamp is used. The measurement may need to be made from the pointer point

(The pointer position is the later needle sleeve position).

7

Measure penetration

depth (distance between

skin and lesion)

MR-BI320-PA

6


4

6

Localization and Biopsy

Process

• In case the marker-lesion axis should intersect with one of the three horizontal

struts of the slat lateral plate and thus prevent direct access to the lesion, or the

penetration should not be made in the direction of the thorax, the angulation angle

of the marker (and thus of the subsequent needle guidance) can be readjusted to

- 0°, -15°, + 15°, + 0°.Your toolbox will then give you the new distance between

marker and lesion with the new angle as described in the following:

• First, you must complete Steps 1 through 4 as described above (Steps 5 through

7 are not relevant in this case).

• Then you must mark the pivot point with a vertical line. This line is (except Ethicon

Mammotome® MR Adaptor) located 22 mm behind the tip of the pointer. (See

Ill. ). Using the Ethicon Mammotome® MR Adaptor, the pivot point is located 22

mm behind the end of the pointer. Please spend special attention, that the pivot

point (end of pointer) is located in the scanning area.

22 mm

Mark pivot point

MR-BI320-PA


Localization and Biopsy

Process

• Draw in a suitable angle (- 0 °, -15 °, +15 ° or + 0°) with the help of the angle

tool.

• Next, determine the needle penetration depth (skin-lesion distance) and the

adjustment in the posterior-anterior direction (at the pivot point).

10

Adjustment

15 °

Needle Penet-

ration Depth

posterior

anterior

Draw angle

Determine penetration

depth and adjustment

MR-BI320-PA

6

5


6

6

Localization and Biopsy

Process

• The biopsy may be performed after adjustment of the guide base settings to the

distance and angulation angle (in this example 15°) determined.

• You can adjust the angle on the guide base when the laser engraved dot on the

set screw is set to “0” (See illustration). Retighten the set screw once you have set

the desired angle. When the requested angle has been adjusted, secure the screw

again.

Set screw to „0“

MR-BI320-PA


Localization and Biopsy

Process

• To get better access to lessions close to the thorax, extend the teleskope bar by

loosening the screw on the backside of the telescopic bar.

• Calculate the distance between skin and lession with the help of the tool box.

• Select the needle sleeve with the proper size needle and mount these in place

of the marker.

• Select a needle with an appropriate length to reach the lesion. Consider to add

the offset a approximately 50 mm to the distance skin-lesion.

Needle Penetration at Incorrect Location

Please take care of using a needle with the appropriate size/

gauge as well as the corresponding needle guide.

Using an inappropriate needle, you might not reach the lesion.

Insufficient penetration depth

Please take care of using a needle with the appropriate

length.

Using too short a needle, you might not reach the lesion.

• Insert the needle to a position ca. 10 mm in front of the lesion.

• Perform a control scan with the inserted needle. Set the distance shown in the

toolbox between the needle point and the lesion on your needle scale and penetrate

with the needle to the lesion.

MR-BI320-PA

6

7


6

Localization and Biopsy

Process

• Perform the biopsy in accordance with the instructions of your needle and/or

vacuum stamp manufacturer.

• After completion of the biopsy, clean the device parts as described in Chapter

“Cleaning, Disinfection and Sterilization.”

Danger of Penetration through the Mamma!

Should, under exceptional circumstances, the needle be bent

while in the mamma (e.g. if the needle should strike one of the

three horizontal slats after penetrating through the mamma),

then clip off the distally deformed needle end with a suitable,

MRT-compatible tool and remove the remaining trocar.

Withdrawal of the needle with the bent end section would injure

the mamma.

Danger of Bruising!

Be absolutely sure to loosen the slat lateral plates before withdrawing

the mamma.

That way bruises or injuries to the patient can be avoided.

Danger of Injury!

Before loosening and withdrawing the mamma, you must remove

all instruments.

If all instruments are not removed, you may injure the breast

of the patient.

MR-BI320-PA


Space for your notes:

Localization and Biopsy

Process

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

MR-BI320-PA

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6

6.1.1 Post&Pillar Adaptor for Ethicon Mammotome® MR

In application with the Ethicon Mammotome® TM MR-Vacuum system, we offer

a modified positioning device with similar functions as the standard version. In

order to support the doctor with the stabilization of the Mammotome holster the

modified unit is larger. Two different sized guide bars replace the telescope bar.

Please also regard Ethicon directions when using this device!

The needle guide girder with mounted pointer has to be inserted in the right lateral

splint of the fiducial holder until it locks in. After that, the fiducial holder can be

placed on one of the guide bars (lateral/cranio-caudal).

Installing horizontal “0” position

Subsequently the guide bar has to be set in the scaled guide rail. The right indicator

must be installed at the “0” base by closing the attachment screw. In order to reach

all positions, there is a right and a left “0” base located at the guide bar for applying

the fiducial holder on the right/left side of the guide bars.

Installing vertical “0” position

The vertical “0” position is indicated by the upper edge of the fiducial holder and the

“0” base at the guide bar. For height adjustments (anterior/posterior) please adjust

the fiducial holder at the requested position and close the adjustment screw.

height and angle adjustment screw

Localization and Biopsy

Process

Guide Plate

lateral

guide bar

Guide Bar

Fiducial Holder

Needle Guide Girder

Pointer

cranio-caudal

guide bar

Guide Fork (Ethicon)

Right Immobilization Plate

scaled Guide Rail

The modified positioning device is now installed and “0” based. In order to extract

markers and coordinates please follow Chapter 6.1 instructions.

MR-BI320-PA


Localization and Biopsy

Process

For horizontal biopsies (no angulations, 0°) the handling of the NORAS Mammotome®

TM adaptor is equal to the standard NORAS positioning devices.

For angulated biopsies please note that the center of rotation varies from the

standard NORAS positioning devices. The center is located 6 mm (not the usual

22mm) behind the head of the pointer, which is visible in the MR image. In order

to calculate the coordinates you have to subtract 6 mm from the position of the

head of the pointers line.

For angulations use, turn the adjustment screw at the front of the fiducial holder

until you are able to change the angle. Anterior as well as posterior angulations

are possible for 15° and 0°. After the angulations adjustment close the adjustment

screw slowly until the new position of the fiducial holder is fixated.

In case of a very anterior lesion position the guide fork (Ethicon) can be set on a

higher position, which enables another 17mm anterior access. Please note that

in this procedure the holster must be held upside down so that tissue samples

will fall downwards.

Horizontal and vertical

Zero Position

height and angle adjustment screw

MR Targeting Set (Ethicon)

Guide Fork (Ethicon)

Lowest adjustable

Position

Targeting Set

MR-BI320-PA

6

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42

6

Localization and Biopsy

Process

After the adjustment of the calculated coordinates please perform a control scan

with installed Ethicon guide fork. The scan shows the pointer as a light line, that

points towards the lesion. The distance between skin and lesion along this line

indicates the insertion depth of the needle inside the breast.

Following to the position and control scans (chapter 6.1), the needle guide girder

with pointer can be replaced from the fiducial holder. Later the targeting-set will

take its place.

For selecting & instruction information about the specific targeting-sets please

look at the manual of your vacuum system manufacturer.

Bodily injuries due to accessories

Please follow the instructions of the accessories manufacturer.

Non-compliance with these instructions may lead to bodily

injuries of the user or patient.

The NORAS Mammotome® MR adaptor is compatible with the

Ethicon Holder for the reception of the Ethicon Mammotome®

MR Universal targeting-sets MRU11S, MRU11X, MRU0 S and

MR0 X.

MR-BI320-PA


Localization and Biopsy

Process

Danger of injury and delocalization

The purpose of the NORAS Mammatome® MR adaptor is

the guidance and positioning of the targeting-set as well as

the vacuum system. In addition, it can carry the targeting-set

individually into the control scan. The adaptor is not capable

to carry the weight of the vacuum system individually. While

the control scan the Mammotome MR targeting-set must not

slip.

6.1.2 Application of the Post&Pillar adaptor for Ethicon Mammotome® MR

in combination with the Siemens - Syngo - Biopsy - Software

In order to identify the coordinates with the Siemens - Syngo - Biopsy – Software

the MR10017-ET-10 block marker is required.

Special designed Pointer (MR10017-ET-10) for application in

combination with Siemens Syngo Software

The block marker has to be inserted in the right lateral splint of the fiducial holder

until it locks in. After that, the fiducial holder can be placed on one of the guide

bars. With the use of the Siemens – Syngo – Biopsy – Software the block marker

replaces the regular needle guide girder with mounted pointer.

Installing horizontal “0” position

Subsequently the guide bar has to be set in the scaled guide rail. The right indicator

must be installed at the “0” base by closing the attachment screw. In order to

reach all positions, there is a right and a left “0” base located at the guide bar.

Installing vertical “0” position

The vertical “0” position is indicated by the upper edge of the fiducial holder and

the “0” base at the guide bar. For height adjustments (anterior/posterior) please

adjust the fiducial holder at the requested position and close the adjustment

screw.

MR-BI320-PA

6

4


44

6

Localization and Biopsy

Process

Now please follow the MR-procedure as described in the Siemens – Syngo – Biopsy

– Software.

In order to identify the basing/reference point please click on the backend of the

light line (close to the doctor), which is visible in the MR image.

MR-BI320-PA


Background

Localization and Biopsy

Process

In this vain the Siemens – Syngo – Biopsy – Software is informed that

the center of rotation of the NORAS Mammotome® MR TM adaptor varies

from the standard NORAS positioning device. The center is located 6 mm

(not the usual 22mm) behind the head of the pointer, which is visible in the

MR image. Please consider this when determinate the insertion depths!

For selecting & instruction information about the specific targeting-sets please

look at the manual of your vacuum system manufacturer.

6.1.3 Post&Pillar Adaptor for SenoRx Encor®

Please follow the instructions of chapter 6.1 „with Post&Pillar Positioning Device“

and the Operator`s Manual of your Vacuum Biopsy Gun.

6.1.4 Post&Pillar Adaptor for Medinvents Coramate®

Please follow the instructions of chapter 6.1 „with Post&Pillar Positioning Device“

and the Operator`s Manual of your Vacuum Biopsy Gun.

6.1.5 Post&Pillar Adaptor for Atec® MRI Standard

Please follow the instructions of chapter 6.1 „with Post&Pillar Positioning Device“

and the Operator`s Manual of your Vacuum Biopsy Gun.

6.1.6 Post&Pillar Adaptor for Bard Vacora®

Please follow the instructions of chapter 6.1 „with Post&Pillar Positioning Device“

and the Operator`s Manual of your Vacuum Biopsy Gun.

MR-BI320-PA

6

45


46

6

Localization and Biopsy

Process

6.2 Grid Fixation Plate

Permanent Damage to the System

The system may only be assembled by trained medical personnel.

Incorrect assembly and operator errors made by untrained

personnel can permanently damage individual parts of optional

components and of the device itself.

In the following, the localization process with mediolateral alignment of the immobilization

device, lateral access and the use of axial slices is described. This

description applies for the use of the system with the compression plate for the

examination of a single mamma. In the case of the simultaneous biopsy of both

breasts (lateral access) use a second immobilization device and a second compression

plate on the other side and proceed in the same way.

Medial and Lateral Access:

Push the compression plate on to the shorter variable position bars of the base

plate as far as it will go. Then push the immobilization plate with the curved insertion

plate on to the longer variable position bars of the base plate also as far as

it will go. Then put the base plate into the round recesses of the insertion plate of

the patient rest. Then align the complete immobilization device in the mediolateral

direction and push the compression and immobilization plates to the end of the

variable position bars. The immobilization device is now open as far as possible.

For medial access, insert the cover plate into the patient rest of the side of the

mamma which is not to be biopsied. Now position the patient on the patient rest

and immobilize the mamma to be biopsied by pressing the compression and immobilization

plates on the variable position bars against the mamma. Be careful

to ensure that the patient can lie as comfortably as possible during the entire

procedure. You now have medial access below the cover plate or lateral access

from the outside.

Cranial/Caudal Access:

To enable cranial/caudal access, proceed as described above to achieve medial/

lateral access. Please note that when the biopsy device is turned in the craniocaudal

direction, the MRI images must be made in the sagital direction to correspond

with the following description. A double cranial biopsy device is available as an

optional accessory to enable simultaneous biopsy of both mammae.

Infection of the patient

Place a sterile tissue on the insertion plate.

Not covering the Insertion plate coil with a sterile tissue may

lead to infection of the patient.

MR-BI320-PA


Localization and Biopsy

Process

Needle Penetration at Incorrect Location

The mamma must be correctly immobilized.

If the mamma is not properly immobilized, then it may slip out

of position, and the data recorded by the MRI are then incorrect.

• Ensure that as much mamma tissue as possible is held between the slat lateral

plate and the compression plate.

• Insert the marker block supplied into the compression plate.

1

Posterior

Medial Lateral

Anterior

• Detect the marker block (1) and the lesion (2) in the MRI using sagittal Slices.

• Mark the lesion with a permanent auxiliary line from the software toolbox of your

MRI device. Go back to the slice where you can see the marker block and the

impression of the grid.

MR-BI320-PA

6

47


4

6

Localization and Biopsy

Process

2

Marker verschieben

• Then insert the marker into the compression plate in such a way that, during the

control scan, it is imaged as closely as possible on the same line as the lesion.

MR-BI320-PA


Localization and Biopsy

Process

• When the marker block and the lesion are in a similar level determine the distance

between the skin and the lesion using your toolbox.

4

5

Distance

penetration depth

• Push the needle block with the desired hole diameter (12 G, 14 G or 1 G) into

the corresponding opening in the compression plate and, using the toolbox, determine

the desired penetration point in the needle block.

MR-BI320-PA

6

4


50

6

Localization and Biopsy

Process

• Select the needle block with the proper size needle and mount these in the calculated

position.

• Select a needle with an appropriate length to reach the lesion. Consider to add

the offset a approximately 25 mm to the distance skin-lesion.

Needle Penetration at Incorrect Location

Please take care of using a needle with the appropriate size/

gauge as well as the corresponding needle guide.

Using an inappropriate needle, you might not reach the lesion.

Insufficient penetration depth

Please take care of using a needle with the appropriate

length.

Using too short a needle, you might not reach the lesion.

• Insert the needle to a position ca. 10 mm in front of the lesion.

• Perform a control scan with the inserted needle. Set the distance shown in the

toolbox between the needle point and the lesion on your needle scale and penetrate

with the needle to the lesion.

MR-BI320-PA


Localization and Biopsy

Process

• Perform the biopsy in accordance with the instructions of your needle and/or

vacuum stamp manufacturer.

Danger of Penetration through the Mamma!

Should, under exceptional circumstances, the needle be bent

while in the mamma (e.g. if the needle should strike one of the

three horizontal slats after penetrating through the mamma),

then clip off the distally deformed needle end with a suitable;

MRI-compatible tool and remove the remaining trocar.

Withdrawal of the bent end section of the needle would cause

injury to the mamma.

Before loosening the mamma, be sure that all instruments are removed.

Danger of Bruising!

Be absolutely sure to loosen the slat lateral plates and compression

plates before withdrawing the mamma.

That way bruises or injuries to the patient can be avoided.

Danger of Injury!

Before loosening and withdrawing the mamma, you must remove

all instruments.

If all instruments are not removed, you may injure the breast

of the patient.

• After completion of the biopsy, clean the device parts as described in Chapter

“Cleaning, Disinfection and Sterilization”.

MR-BI320-PA

6

51


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6

Localization and Biopsy

Process

6.2.1 Grid Needle Block Adaptor for Ethicon Mammotome® MR

For use with the Ethicon Mammotome® MR the NORAS Company offers reusable

needle block adapter made of PEEK. These ensure the compatibility of the

Mammotome® MR Universial targeting-sets MRU11S, MRU11X, MRU0 S and

MRU0 X with the NORAS grids. The positioning process is described in chapter

6.2. After the successful positioning process of the needle block adaptor and the

control scan please follow the Mammotome® MR manual from Ethicon in order

to accomplish the biopsy procedure.

6.2.2 Grid Needle Block Adaptor for SenoRx Encor®

For use with the SenoRx Encor® mammo biopsy system the NORAS Company

offers reusable needle block adapter made of PEEK. These ensure the compatibility

of the SenoRx Encor® biopsy system (Encor canulas and probes with

7G, 1G and 12G) with the NORAS grids. The positioning process is described in

chapter 6.2. After the successful positioning process of the needle block adaptor

and the control scan please follow the SenoRx Encor® biopsy system manual

from in order to accomplish the biopsy procedure.

6.2.3 Grid Needle Block Adaptor for Medinvents Coramate®

For use with the Medinvents Coromate® mammo biopsy system the NORAS

Company offers reusable needle block adapter made of PEEK. These ensure

the compatibility of the Medinvents Coromate® mammo biopsy system (canulas

and probes with G and 10G) with the NORAS grids. The positioning process is

described in chapter 6.2. After the successful positioning process of the needle

block adaptor and the control scan please follow the Medinvents Coromate®

mammo biopsy system manual from in order to accomplish the biopsy procedure.

6.2.4 Grid Needle Block Adaptor for Atec® MRI Standard

For use with the Atec® MRI Standard biopsy system the NORAS Company offers

reusable needle block adapter made of PEEK. These ensure the compatibility

of the Atec® MRI Standard biopsy system (canulas and probes with G) with

the NORAS grids. The positioning process is described in chapter 6.2. After the

successful positioning process of the needle block adaptor and the control scan

please follow the Atec® MRI Standard biopsy system manual from in order to

accomplish the biopsy procedure.

MR-BI320-PA


Localization and Biopsy

Process

6.2.5 Grid Needle Block Adaptor for Bard Vacora®

For use with the Bard Vacora® vacuum biopsy system the NORAS Company offers

reusable needle block adapter made of PEEK. These ensure the compatibility of the

Bard Vacora® vacuum biopsy system (canulas and probes with 10G) with the NO-

RAS grids. The positioning process is described in chapter 6.2. After the successful

positioning process of the needle block adaptor and the control scan please follow

the Bard Vacora® vacuum biopsy system manual from in order to accomplish the

biopsy procedure.

MR-BI320-PA

6

5


54

6

Localization and Biopsy

Process

6.2 MRI Mammography

Permanent Damage to the System

The system may only be assembled by trained medical personnel.

Incorrect assembly and operator errors made by untrained

personnel can permanently damage individual parts of optional

components and of the device itself.

In the following, the mammographic imaging process with the mediolateral alignment

of two fixing and immobilization devices for the simultaneous diagnosis of

the left and right mamma is described.

• Insert base plates into the insertion plate coil on the right and left sides in such

a way that two immobilization plates with one slat lateral plate each can be used

mediolaterally on both sides (laterally with the curved slat lateral plate supplied,

also horizontally for possibly improved patient comfort).

Infection of the patient

Place a sterile tissue on the insertion plate.

Not covering the Insertion plate coil with a sterile tissue may

lead to infection of the patient.

• Position the patient on the patient rest and immobilize the mammae to be examined

by pressing the slat lateral plates on the variable position bars in such a way

that the patient can lie as comfortably as possible during the entire examination.

• Ensure that as much mamma tissue as possible is held between the slat lateral

plates.

• Use the toolbox of your MRI device to determine the ROI, FOV and type of sequence.

• Perform the mammographic procedure.

Danger of Bruising!

Be absolutely sure to loosen the slat lateral plates and compression

plates before withdrawing the mammae. To do so,

simultaneously push the left and right slides and pull the lateral

slat plate outwards.

That way bruises or injuries to the patient can be avoided.

MR-BI320-PA


6.3 Safety Information

Localization and Biopsy

Process

Please consider the following when using the MR-BI320-PA:

Damage to Coils!

When transporting the insertion plate coil, carry it only by its

housing, not by its cables. Never carry the patient pad coil by

its loops and do not bend it. Connection cables must not be

bent or knotted.

Defective coils (including their cables, shield traps and plugs)

must not be used.

Permanent Damage to the System

The system may only be assembled by trained medical personnel.

Incorrect assembly and operator errors made by untrained

personnel can permanently damage individual parts of optional

components and of the device itself.

Product lifetime

The useful product lifetime (for safe use) is 5 years, purchase

date must be observed. (See Page 5, General Information).

The system is not allowed to be used after expiration of this

time limit.

RF burns

Please take care that the patient

does not place his extremities

in such a way that they form a

closed circle/loop.

A closed circle/loop might result

in RF burns of the patient.

MR-BI320-PA

6

55


56

6

Localization and Biopsy

Process

In order to enable reliable navigation, the

marker must be displayed in the MRI image

as a straight line. If the marker is imaged with

a kink or offset similar to that shown in the

adjoining illustration, repeat the image with

a reversed phase code direction.

MR-BI320-PA


Cleaning, Disinfection

and Sterilization

7. Cleaning, Disinfection and Sterilization

7.1 Cleaning

Patient Rest Damp Cloth (moisten with lu-

Patient Pad Coil

kewarm water)

Insertion Plate Coil

Wedge Pad

Head Rest

Immobilization and Fixing Device Water Bath

possibly using a soft brush

Needle Blocks and Needle Guides Ultrasound Bath

possibly with precleaning with a

spraying device or water nozzle

After each patient examination, the patient rest, insertion plate coil, patient pad

coil, wedge pad, head rest, immobilization and fixing device as well as the needle

blocks and needle guides must be cleaned as described above. The products used

should be cleaned within 0 minutes after use to minimize the danger of the drying

of contaminants prior to cleaning. We recommend that the components be cleaned

immediately after the examination/biopsy.

Disassemble the immobilization and fixing device into its individual parts so that they

can be thoroughly cleaned.

Clean the above mentioned parts until no visible blood or tissue residues can be

recognized on the products themselves or in the water bath/ultrasound bath or on

the damp cloth.

Do not use any scouring cleaning agents or, due to possible material incompatibility,

any organic solvents or solvent-containing cleaning agents (e.g. cleaner’s solvent,

alcohol, stain remover)!

Danger of destruction!

The insertion plate coil and the patient pad coil must not be

cleaned in immersion baths or held under running water. Danger

of destruction!

Noncompliance with the cleaning instructions may cause the

destruction of the coils.

MR-BI320-PA

7

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5

7

Cleaning, Disinfection and

Sterilization

7.2 Disinfection

All components of the MR-BI320-PA must be disinfected after each use. Patient

examinations and biopsies of patients may only be performed with disinfected

components.

Aqueous solutions of commercially available, aldehyde- or amphotenside-based,

surface disinfectants are suitable to disinfect the system components.

Solution Duration to be disinfected

Patient Rest Bacillol ® AF, Bode

Company, Hamburg,

Germany

Kodan ® 5 minutes After each

Patient Pad Coil

use

Insertion Plate Coil

Wedge Pad

Tinktur Forte

Head Rest

Immobilization and

Fixing Device

colorless, Schülke &

Mayr Company, Norderstedt,

Germany

1 minute

Needle Guides and

Needle Blocks

Danger of destruction!

Completely

submerge

each component

for

at least 5

minutes in

solution. Disinfection

with

ultrasound

bath is also

permissible

Patient pad coil and insertion plate coil must not be disinfected

in an immersion bath. Danger of destruction!

Non-respect of the disinfection instructions may cause the

destruction of the coils.

MR-BI320-PA


Cleaning, Disinfection

and Sterilization

Notice

Please always wear protective gloves and carefully comply with

the application times for Hepatitis B and HIV viruses (See the

instructions for use of the respective disinfectant solution).

As during the cleaning process, leave the immobilization and fixing device in its

individual parts so that optimum disinfection can be ensured.

Danger of destruction!

Improper disinfection may result in malfunction of the device.

Noncompliance with the cleaning instructions may destroy the

system! No warranty service will be provided for damages

due to improper disinfection.

Danger of Infection!

The instructions for desinfection must be followed.

In the case of inadequate disinfection, the operator and/or the

patient may be infected.

MR-BI320-PA

7

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60

7

7.3 Sterilization

Cleaning, Disinfection

and Sterilization

Only the needle guide blocks and the needle sleeves must be sterilized after

each use. After cleaning and disinfection, these parts must be packed due to the

established and validated process in you facility and steam sterilized (1 4 °C,

.04 bar, 5 min).

The markers must be emptied prior to sterilization. See Chapter “Marker Filling

Instructions“.

Thereafter, the sterilized parts should be stored just like other sterilized products

in your facility.

The coils (patient pad coil and insertion plate coil) as well as the patient rest, the

wedge pad and the head rest are not sterilizable.

Danger of Destruction!

Improper sterilization may result in malfunction of the device.

No warranty service shall be provided for technical defects

of the patient pad coil and the insertion plate coil caused by

improper sterilization.

Danger of Infection!

The instructions for sterilization must be followed.

In the case of inadequate sterilization, the operator and/or the

patient may be infected.

Variations in terms of color due to sterilization

The sterilization agent can cause variations in terms of color.

This has no influence on the quality of the product.

MR-BI320-PA


Maintenance, Storage

and Waste Disposal

8. Maintenance, Storage and Waste Disposal

8.1 Maintenance

Prior to each use, all components of the MR-BI320-PA must be visually inspected.

Patient Rest Control for breakage

and cracks

Patient Pad Coil/Cable and Plug Control for breakage and

Insertion Plate Coil /Cable and Plug

cracks

Immobilization and Fixing Device

Defective products must not be used. In such a case, please contact the NORAS

Customer Technical Service Organization.

Comply with the cleaning, disinfection and sterilization instructions!

We recommend that you have a single channel test of the coils performed on

a monthly basis using the specified test program of the MRI system. The data

regarding the test performance and its results must be recorded in the medical

devices log book.

MR-BI320-PA

61


62

Functional Tests

Maintenance, Storage

and Waste Disposal

In case coil malfunctions are suspected, the operator may perform the functional

test described below.

Insert the standard Siemens 2 l phantom bottles into the coil as shown on the

illustration and connect the coil to the MRI scanner.

Coil with two 2 l phantom bottles,

“Head first”

Be sure to insert the bottles into the biopsy device in place and not directly into the

recesses of the insertion plate. Make sure the bottles are positioned in the center

of the loops of the patient rest pad.

Phantom bottle positioned in center of loop at height S7

If you want to position the patient rest for a “feet first” measurement in an MRI

scanner without a whole body option, (that is, a scanner in which the table cannot

be fully transported through the scanner), the center of the bottle may be positio-

ned, at maximum, at the end of Sector S7 (See above illustration).

MR-BI320-PA


Maintenance, Storage

and Waste Disposal

To prepare for the measurement, first align the laser sight on the bottles centrally

between the loops and transport the coil into the iso-center. Take a normal localizer

sequence measurement and then position the slice of a standard Siemens “gre”

(gradient echo sequence) axially centered through the bottles.

You can find this sequence under “Siemens/Sequence Region/Siemens Sequences/Default

Protocols/gre.

Centrally align the laser sight

between the loops.

Sequence

Siemens/Sequence Region/Siemens Sequences/Default Protocols/gre

MR-BI320-PA

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64

Maintenance, Storage

and Waste Disposal

Then make the following final sequence adjustments:

- Field of view = 60 mm

- Coil selection: all four channels of the breast coil (Menu: System,

Subitem: Coils)

Select four channels

Field of view

MR-BI320-PA


Maintenance, Storage

and Waste Disposal

- Store individual channel data separately

Now you can start the measurement.

Store

separately

The illustration shows that the four coil channels are producing a good quality,

artefact-free signal.

MR-BI320-PA

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66

Maintenance, Storage

and Waste Disposal

If the images produced during your measurement appear significantly different from

the above (e.g. the image contains bands or one channel with a clearly weaker

signal, then a coil may be defective. In this case, please contact the Noras MRI

products GmbH.

Display of four channels

MR-BI320-PA


8.2 Storage

10°


8.3 Waste Disposal

Maintenance, Storage

and Waste Disposal

Following its use and the required cleaning, disinfection and

sterilization, the device should be stored at room temperature

in a dust-free, UV radiation-protected location (min. 10 °C, max.

0 °C). In the case of resterilized needle sleeves, you must not

exceed the maximum storage period (currently 6 months if stored

in single or double packaging in protected storage in dust-tight

containers, cabinets, drawers or similar places).

All of the materials used in the manufacture of the system components can be

conveniently recycled and therefore do not present any particular or unusual hazards

during their disposal.

Prior to disposal, the system must be disinfected as described above to eliminate

any risk of infection.

Following their final use, the patient pad coil and the insertion plate coil should be

returned to the manufacturer for disposal.

We would be happy to provide you with additional information about disposal

upon request.

MR-BI320-PA

67


6

MR-BI320-PA


Technical Specifications

9. Technical Specifications

9.1 Historical Device Data

Designation (Model/Type)

MR-BI 20-PA

Manufacturer:

NORAS MRI products GmbH

Leibnizstraße 4

7204 Höchberg

Germany

Regulatory Product Approval

Certificates

Operation Type

active nonactive

Product Class / Device Class

IIa (per MDD Annex IX Rule 10)

Identification Number of Notified

Body ( -Marking)

012

Product Type / Device Type (according

to UMDNS / DIMDI)

MRI Device, mammographic

(1 -110)

Supplier:

Operator’s Manual

.2 of June 20, 200

Test / Control (Time Limits / Type)

Intended Purpose according to information

provided by the Manufacturer:

The device is intended for use during the MRI

examination of the female breast. Biopsies

can also be made with the system.

Serial Number

see Warranty Registration

MR-BI320-PA

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70

Technical Specifications

9.2 Performance Data

Operating Temperature Corresponding with the air-conditioned

room temperature of the MRI room

Storage Temperature Room Temperature

Protection Class IIa

Weight 1 ,5 kg

Dimensions height: 1 0 mm

width: 460 mm

length: 740 mm

Resonance frequency 1.5T: 6 ,6 MHz

T: 12 ,2 MHz

Interfaces Electrical: SIEMENS MRI

Mechanical: MRI Patient Rest

Maximum Operating Time of Coils Continuous Operation

Field of view 160 mm x 20 mm x 160 mm

MR-BI320-PA


9.3 Parts List

Technical Specifications

Breast Basis Set MR10315-NO

Patient Rest

Wedge Pad

Head Rest

Fixation Rail

4 Ch BI Breast MR Coil Kit

Patient Pad Coil 1.5T: MR10 0

T: MR105 0

Insertion Plate Coil 1.5T: MR10 0

T: MR105 0

MR-BI320-PA

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72

Technical Specifications

Biopsy Training Kit - Post & Pillar and Grid (BI160-2) MR10360-NO

Immobilization Device: for plug-in into the insertion plate

coil for the right or left breast; 60° rotatable

For medial, lateral and craniocaudal biopsy; 270° biopsy access

Positioning Device incl. needle guide sleeves

for 1 , 16 and 1 G needles and one marker

Grid with needle blocks for 12, 14 and 1 G needles.

Two markers are integrated in the grid.

An insertion breast plate for the patient rest is supplied for use

during a medial biopsy to elevate the breast not being biopsied.

In conclusion: Qty Order Number

Base Plate 1 MR100 -20

Lateral/Medial Immobilisation Plate 2 MR10040- 0

Slat lateral frame 2 MR100010-10

Curved insertion plate, horizontal 1 MR10010-PAH-10

Positioning System 1 MR10062-PA-10

Oil marker 1 MR10017-10

Needle Sleeve Set 1 MR10015-10

Compression Plate 1 MR100 1- 0

Needle Block Set 1 MR100 2-10

Marker Block 1 MR10021-10

Insertion breast plate 1 MR10 1

Store Box 1 MR10067

MR-BI320-PA


9.4 Options and Accessories

Technical Specifications

Slat Lateral Frame, vertical MR10010-20V

Curved inserton plate, vertical MR10010-PAV

Insertion Plate MR10042-10

CAD Marker MR10017-D-10

Buide Base MR10014-10

Needle Sleeve Set sith 1 G, 16 G, 1 G MR10015-Gauge

Marker Block MR10021-10

Guide Plate for GL MR1005 -

Needle Block Set with 12 G, 14 G, 1 G MR10062/ 2/

Post&Pillar Adaptor for Ethicon® Mammotome MR

Post&Pillar Adaptor for SenoRx Encor®

MR-BI320-PA

7


74

Technical Specifications

Post&Pillar Adaptor for Medinvents Coramate®

Post&Pillar Adaptor for Atec® MRI Standard

Post&Pillar Adaptor for Bard Vacora®

Grid Needle block Adaptor G and 11 G

for Ethicon® Mammotome MR

Grid Needle block Adaptor for SenoRx Encor®

Grid Needle block Adaptor for Medinvents Coramate®

Grid Needle block Adaptor for Atec® MRI Standard

Grid Needle block Adaptor for Bard Vacora®

Operator`s Manual GA-BI 20-PA1

Log book LB-BI 20-PA1

MR-BI320-PA


MR-BI320-PA

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76

10 Declaration of Conformity

The 10. Manufacturer Declaration of Conformity

NORAS MRI products GmbH ISO 13485:2003

Leibnizstrasse 4 certified by

7204 Höchberg TÜV-PS

Germany

herewith confirms in accordance with the conformity assessment procedure of

Annex II of the Council Directive /42/EEC of 14 June 1 concerning medical

devices that the

MR-BI320-PA Immobilization and Biopsy System

for MRI-supported, mammographic biopsy with the

NORAS PIC Breast Coil System and the PA 20

Patient Rest

Attention!

with all of the options and accessory parts described in the Operator’s Manual

fully complies with the essential requirements of the Council Directive /42/

EEC of 14 June 1 concerning medical devices.

The System is identified as an active medical device in accordance with Annex

IX, Paragraph III, Rule 10 of the above-mentioned Directive and belongs

therefore to Class IIa, according to Rule I for noninvasive products.

This declaration applies to all devices starting with serial number: 001

and is submitted in the name of the manufacturer by the responsible party

Hubert Noras

04.10.2006

Managing Director

MR-BI320-PA


11. EC Declaration

Further declarations on request

EC Declaration 11

MR-BI320-PA

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7

12

Important Addresses

12. Important Addresses

Manufacturer (Product Development and Production)

NORAS MRI products GmbH

Leibnizstraße 4

7204 Hoechberg

Germany

Telefon: +4 1/2 27-0

Telefax: +4 1/2 27-20

E-mail: mri@noras.de

Internet: www.noras.de

Your Sales Partner and Customer Technical Service Organization

In case you do not find the name

of a NORAS sales and/or customer

service representative

here, please contact NORAS

MRI products GmbH directly.

MR-BI320-PA


13. Warranty Scope

Warranty services will only be provided for unopened coils which have been properly

cleaned, disinfected and sterilized.

Please store the warranty card in a safe place. All of the technical components

of the MR-BI320-PA Immobilization and Biopsy System are covered by a 12

month warranty.

A prerequisite for warranty service is that you have handled your MR-BI320-PA

Immobilization and Biopsy System in the proper way. No warranty service will be

provided for damages incurred due to improper use and handling of the system.

Important Information:

Warranty Scope 1

The corresponding warranty documents can be found in the end of the Operator‘s

Manual.

MR-BI320-PA

7


0

14 Training Certificate

14. Training Certificate

This certificate confirms that the training in the handling and use of the MR-BI320-

PA Immobilization and Biopsy System has been properly conducted.

The contents of the training did not address the general hazards of magnetic

fields.

With regard to the hazards of magnetic fields, it is absolutely necessary that you

read the Operator’s Manual of the MR-BI320-PA Immobilization and Biopsy

System as well as the system handbook of the MRI system.

Subject of the Training:

System Start-up

Localization and Biopsy Process

MRI Mammography

Cleaning, Disinfection and Sterilization

Performance of a Single Channel Test

Summary of Resulting Hazards by the Technician/Trainer

I have been trained in the handling of the MR-BI320-PA Immobilization and

Biopsy System.

I have taken notice of the contents of this certificate and am familiar with the

handling of the MR-BI320-PA Immobilization and Biopsy System.

Name/Participant Signature

Clinic Ward/Department

Date Technician/Trainer

MR-BI320-PA


15. Warranty Registration

Warranty Registration 15

Please send this section to the Manufacturer.

The lower section should be kept in the Operator‘s Manual.

Device/Designation: MR-BI320-PA

Serial Number:

Warranty Start Date:

Operator:

Section 2:

Stamp / Signature of the Authorized Dealer

1. We herewith warrant that the MR-BI320-PA Immobilization and Biopsy System

listed in the Medical Devices Log Book is free of defects in material and workmanship

in accordance with the respective state-of-the art for such products for a

period of

12 months

following the day on which such product has been delivered to the Operator.

2. We herewith obligate ourselves to eliminate, free of charge, damages to the

device caused by defects in material or workmanship and which impair the functionality

of the coil.

. No warranty service shall be provided, if the Operator has not followed the instructions

for use in the Operator’s Manual and/or has used the device in a way not

in accordance with its intended purpose. Furthermore, no warranty service shall be

provided if the device has been modified by an unauthorized party. Warranty service

will only be provided for unopened coils.

4. The elimination of a defect covered by warranty must be handled by the Authorized

Dealer, who shall inform the Manufacturer accordingly.

MR-BI320-PA

1

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