Manual BI160-GE - NORAS MRI products GmbH

noras

Manual BI160-GE - NORAS MRI products GmbH

NORAS Immobilization and Biopsy System BI160-GE

Immobilization and

Biopsy System BI160-GE

for Immobilization and MRI-supported

Mammographic Biopsy with the

GE 8-channel Breast Coil

Operator`s Manual

Revision 3.4

english

06/2009


BI160-GE


Contents

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

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

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

4. Device Description ..............................................................8

4.1 Defi nitions and Symbol...........................................................8

4.2. System Component10...........................................................10

4.2.1 Option 1 - Grid........................................................................10

4.2.2 Option 2 - Positioning Device (Post&Pillar)....................... 10

4.2.3 Combination with other Devices..........................................10

5. Start -up ..............................................................................12

5.1 Option 1 - Fixation Plate/Grid ................................................13

5.2 Option 2 - Positioning Unit ....................................................15

6. Localization and Biopsy Process .....................................18

6.1 with Grid Fixation Plate .........................................................18

6.2 with Positioning Device .........................................................25

6.2.1 Post&Pillar for Ethicon Mammotome ® MR...........................37

6.2.2 Application of the Post&Pillar adapter for Mammotome ® ...40

6.3 Safety Information ..................................................................41

6.4 Marker Filling Instructions ....................................................42

7. Cleaning, Disinfection and Sterilization ..........................44

7.1 Cleaning ..................................................................................44

7.2 Disinfection .............................................................................45

BI160-GE

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Contents

7.3 Sterilization .............................................................................47

8. Maintenance, Storage and Waste Disposal .....................48

8.1 Maintenance ..........................................................................48

8.2 Storage ....................................................................................48

8.3 Waste Disposal .......................................................................49

9. Technical Specifi cations ...................................................50

9.1 Historical Device Data ...........................................................50

9.2 Performance Data ..................................................................51

9.3 Parts list ..................................................................................52

10. Declaration of Conformity .................................................53

11. Important Addresses .........................................................55

12. Warranty Scope..................................................................56

13. Training Certifi cate ............................................................57

14. Package ..............................................................................58

15. Warranty Registration .......................................................59

BI160-GE


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 Immobilization and Biopsy System BI160-GE can only be used with

the GE High Density Mamma Coil.

FDA caution

Federal law restricts this device to sale, distribute and use

by or on the order of a physician.

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

training program with the device using a phantom! You can order a phantom from

NORAS MRI products GmbH. 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 any further development

of or new accessories for your Immobilization and Biopsy System, please

send an e-mail with the serial number of your BI160-GE 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 adapters at the latest after 2

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

BI160-GE

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6

2 Intended Purpose

2. Intended Purpose

The BI160-GE is a medical device and is used to immobilize the female breast and

for MR supported assistance for puncture, tissue removal and minimally invasive

procedures. It may only be used by trained personnel in clinical situations.

With the aid of the immobilization grid the breast is held fi rmly during the examination.

The needle can be positioned and guided using the grid or a positioning system.

Indication

Tissue removal from medial and lateral direction.

Contraindication

Option Grid

Option Positioning Device

(Post&Pillar)

All examinations are contraindicated that are contraindicated for MRI according

to GE (e.g. breast implants, pace makers, surgical metal implants or similar).

Furthermore in the event of unclear or critical symptoms, responsibility lies with

the treating doctor.

BI160-GE


3. Operating Principle

Operating Principle

The immobilization of the breast is done in the mamma coil in a mediolateral

direction. After localization of the lesion (following a diagnostic examination), the

coordinates obtained are transferred to the positioning unit or the grid.

Safety Concept

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 of the patient.

The control scan procedure is described in Chapter “Localization and Biopsy

Process”, in the description of the biopsy procedure, and the correct result

illustrated in the text.

BI160-GE

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4 Device Description

4. Device Description

4.1 Defi nitions and Symbols

The following symbols are used on the BI160-GE Immobilization and Biopsy

System:

Caution, read the accompanying documents

Follow the instructions in the Operator`s Manual

Temperature Limit

SN Serial Number

PN Part Number

MOD Modell

This product conforms with the essential requirements

of Council Directive 93/42/EEC of 14 June 1993

concerning medical devices.

Warning, immediate hazard for the device!

Caution, immediate hazard for persons!

Information regarding handling of the device

On the following page, it will be described where you can fi nd the various rating

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

fi nd the model, product and serial numbers on these plates.

BI160-GE


Rating Plates

Compression Plate

Gerätebeschreibung

The rating plate is located on the top edge of the grid.

medial:

lateral:

Positioning Device

The rating plate is located on the top edge of the Device.

medial:

lateral:

BI160-GE

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Device Description

4.2 System Components

4.2.1 Option 1 - Grid

The grid set is comprised of a medial and a lateral grid (depending on your

ordered Option with four incorporated markers) one marker block and a needle

block set.

4.2.2 Option 2 - Positioning Device (Post&Pillar)

The positioning unit is comprised of a medial and a lateral frame and two

positioning systems.

BI160-GE


4.2.3 Combination with other Devices

System Components

Special NORAS adapters 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 fi rmly 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 adapters, see Datasheet

„Adapter“ on our homepage or send an e-mail to mri@noras.de.

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

a needle guide.

Additional adapter systems can be custom-manufactured upon request.

Notice

The BI160-GE system may only be operated in combination

with the devices named above, the GE High Density Mamma

Coil and any accessories provided by NORAS MRI products

GmbH. The use of other accessories is only allowed with the

written permission 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.

BI160-GE

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25 Start-up

5. Start -up

Device Damage

Only trained personnel may be assigned to handle the BI160-

GE.

Operating errors may cause permanent damage to the device.

Bodily Harm

Only trained personnel may be assigned to handle the BI160-

GE.

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

to the patient and/or operator.

Danger of Infection

Before beginning to operate the unit or any of its parts, all parts

are to be treated as per the section on Cleaning, Disinfection

and Sterilization.

Non-compliance 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.

Bodily Harm of the end user

Prior to each patient examination, you should make a careful

visual inspection of the system components. If anything unusual

and/or damage are found, the system must not be used.

Defective parts can have sharp edges and lead to injury of

the patient and/or the operator.

BI160-GE


5.1 Option 1 - Fixation Plate/Grid

The medial grid is introduced from the side and locked onto the middle bridge

of the coil using gentle pressure on the lug.

Product lifetime

The lifespan (See chapter „General Information“) of the product

must be noted. After this has lapsed the system should

no longer be used.

Bodily danger

Start-up

Press the lug down. Lock grid/positioning unit in.

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

screwdrivers are available, then you must fi ll the

oil markers outside of the MRI room

BI160-GE

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5 Start-up

The pins and fi xation clips of the lateral grids or the lateral positioning unit have to

be plugged into the GE-coil simultaneously. Use both hands and slight pressure

(see picture below).

Pay attention that the guide pins are completely inserted into the holder and the

fi xation clips are snaped in.

Pay attention to the operating instructions of the coil manufacturer.

Position the coil with the immobilization and biopsy unit on the MR table according

to the manufacturer‘s instructions.

Danger of Infection

Before beginning to operate the unit or any of its parts, all parts

are to be treated as per the section on Cleaning, Disinfection

and Sterilization.

Non-compliance may lead to infection of the patient.

BI160-GE


5.2 Option 2 - Positioning Unit

The medial positioning unit is inserted from the side analogous to the compression

plate (grid) and locked onto the middle bridge of the coil using gentle

pressure on the lug.

The GE coil is plugged on the four pins of the lateral positioning unit.

pins

fi xation clip

For a better fi xation, the lateral positioning unit has a fi xation clip on each side.

Snap these clips into the GE coil.

Please take care that

the pins are completely

inserted in the coil

(see illustration on the

right).

Start-up

BI160-GE

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5 Start-up

Position the coil with the immobilization and biopsy unit on the MR table according

to the manufacturer’s instructions.

Danger of Infection

Before beginning to operate the unit or any of its parts, all parts

are to be treated as per the section on Cleaning, Disinfection

and Sterilization.

Non-compliance may lead to infection of the patient.

Product lifetime

The lifespan (see chapter „General Information“) of the product

must be noted. After this has lapsed the system should

no longer be used.

BI160-GE


Removal

Start-up

To remove the lateral positioning unit and the lateral grid, push them as far as

possible in medial direction into the coil. Then loose the right and left fi xation

clip simultaneously (see picture below) with even preassure. Be careful not to

damage the system..

Insert the lateral unit completely Loosen the lateral unit with simultaneous

slight pressure on both sides

To release the medial positioning unit and the lateral grid, push the big fi xation

clip slightly and draw the unit out of the coil.

Remove the medial unit with slight preasure on the big fi xation clip.

BI160-GE

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6

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 with 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 lateral access and the use of axial

layers is described. This description is valid for the use of the positioning unit for

examination of a breast. To access a breast for a medial biopsy the components

are correspondingly transposed.

• Both grids are inserted as described in the section “Installation”.

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

by pressing the slat lateral plate and the compression plate on the variable

position bars so that the patient can lie as comfortably as possible throughout

the entire examination.

Needle Penetration at Incorrect Location

The breast must be correctly immobilized. Please check

this.

If the breast 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 breast tissue as possible is held between the slat lateral

plate and the compression plate.

BI160-GE


• Detect the marker block (1) and the lesion (2) in the MRI using axial slices.

1

Localization and

Biopsy Process

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.

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Localization and

Biopsy Process

2

• 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.

3

Distance

BI160-GE


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 18 G)

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

determine the desired penetration point in the needle block.

BI160-GE

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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.

Insuffi cient 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.

BI160-GE


• 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.

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!

Localization and

Biopsy Process

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”.

BI160-GE

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6

Localization and

Biopsy Process

Space for your notes:

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BI160-GE


6.2 with Positioning Device

Localization and

Biopsy Process

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 lateral access and the use of axial

layers is described. This description is valid for the use of the positioning unit for

examination of a breast. To access a breast for a medial biopsy the components

are correspondingly transposed.

• Both grids are inserted as described in the section “Installation”.

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

by pressing the grid bars on the lateral grid. Ensure that the patient is lying

as comfortably as possible throughout the examination.

Puncture at the wrong place

The breast must be correctly immobilized. Please check

this. if the breast is not immobilized properly, it might slip

and the data delivered by the MRT will be wrong.

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

plates.

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6

Localization and

Biopsy Process

• Adjust the scales of the guide base, the guide bar and the angulation angle of

the needle guide on the positioning unit to zero (horizontal and vertical) and turn

the marker in one of the needle guides (right or left) so that it is in the middle of

the positioning unit. If necessary the guide bar can be removed after loosening

the rear screw.

Marker in center of device

• Insert the positioning unit onto the pins of the immobilization plate now.

• Detect the fi ducial marker in the MRI using axial slice (1 and 2).

1

Set angulation angle,

guide base and guide

bar to „0“ position

BI160-GE


2

Fiducial

Marker, right

Localization and

Biopsy Process

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

your MRI device.

3

2 nd Slice

Draw auxiliary line

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6

Localization and

Biopsy Process

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

which the lesion was detected (Illustration 4).

4

Linie auswählen

Copy line

Copy and insert

reference line

BI160-GE


Localization and

Biopsy Process

• Detect the lesion and determine the distance between the marker and lesion

using a new line with the distance measuring device.

5

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

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6

6

Localization and

Biopsy Process

• With the help of slices, the head fi rst adjustment is determined considering the

table position.

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

Exampel: Slice of the Marker: 20

Slice of the lesion: 30

slice thickness 2 mm

30-20 = 10

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

BI160-GE


• The patient is then brought out of the magnet core. Ensure that the table movement

does not exceed the automatically set maximum table travel point, otherwise

the laser setting must be repeated and the table position be re-read.

• Position the marker on the calculated position and run the table back into the

magnet for a control scan. The lesion must be in the same plane as the marker

for the new images.

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

instructions for use of the corresponding software or vacuum pistol if used. It

may be necessary to make the measurement here from the pointer point.).

7

Localization and

Biopsy Process

Measure needle penetration

depth (distance between skin

and lesion).

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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

-30°, -15°, + 15°, +30°.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 located 22

mm behind the tip of the pointer. (See Ill. 8).

8

22 mm

Mark pivot point

BI160-GE


• Draw in a suitable angle (-30°, -15°, +15° or +30°) with the help of the angletool.

Draw angle

9

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

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

10

Adjust-

Localization and

Biopsy Process

15 °

Mark pivot point

Needle Penetration

Depth

Determine penetration

depth and adjustment

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6

Localization and

Biopsy Process

• Following adjustment of the guide base for the skin lesion distance and the angulation

angle (15 ° in the example), the biopsy can be performed as described

in the section “Device Use.”

• The angulation angle (15° in the example) can be adjusted on the guide base

when the black dot on the locking screw is in line with the black line between

both 15° markings.

11

Set screw to „0“

BI160-GE


Localization and

Biopsy Process

• Extend the guide bar like a telescope by loosening the screw on the back of

the scale, to get better access to the area near the chest wall.

• Determine the distance between skin and lesion with the help of the toolbox.

• 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.

Insuffi cient 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.

BI160-GE

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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.

BI160-GE


6.2.1 Post&Pillar Adaptor for Ethicon Mammotome® MR

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

modifi ed positioning device with similar functions as the standard version. In order to

support the doctor with the stabilization of the Mammotome holster the modifi ed unit

is larger. Two different sized guide bars for MR BI320-PA were replaced for BI160-

GE with the new lateral guide bar (illustrated below). Please also regard Ethicon

directions when using this device!

Lateral Guide Bar Guide Plate MR10779-GE Lateral Grid MR10010-GEL

The marker pointer has to be inserted in the right/left lateral splint of the fi ducial

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

guide bars (lateral).

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 “1.0” 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 fi ducial holder on the right/left side of the guide bars.

Scaled Guide Rail MR10751-GE Adjustment Screw

MR10763

Needle Guide Girder

MR10761-20

Position Guide Right MR10780RGE

Position Guide Left MR10780LGE

Lateral Grid MR10010-GEL

Scaled Guide

Guide Bar Rail MR10751-GE

Marker Pointer MR10017-ET-10

Installing vertical “0” position

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

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

the fi ducial holder at the requested position and close the adjustment screw.

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

BI160-GE

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

Mammotome® MR 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 68mm (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 68mm from the position of the

head of the pointers line.

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

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

are possible for 15° and 30°. After the angulations adjustment close the adjustment

screw slowly until the new position of the fi ducial holder is fi xated.

Mammotome ® MR Adapter Set for GE 8 ch Breast Coil

MR10062-ET-GE

Targeting Set mit

Halterung (Ethicon)

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.

BI160-GE


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

installed Noras Special Marker Pointer. 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 Noras marker pointer can

be replaced from the needle guide girder. Later the targeting-set will take its place.

For selecting & instruction information about the specifi c 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, MRU08S and

MR08X.

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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 during

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 GE MRI System

In order to identify the coordinates with the GE MRI System the MR10017-ET-10

marker pointer is required.

Special designed pointer (MR10017-ET-10)

for application with GE MRI System Software

The marker pointer has to be inserted in the right lateral splint of the needle guide

girder until it locks in. After that, the marker pointer can be placed on the guide

bar. With the use of the GE MRI System for example Signa 1.5T the marker pointer

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 needle guide grider

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

adjust the needle guide grider at the requested position and close the adjustment

screw.

BI160-GE


6.3 Safety Information

Please consider the following when using the MR-BI160:

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

Do not use the system after expiration of its useful lifetime.

See Page 5.

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.

Localization and

Biopsy Process

BI160-GE

6

41


42

6

Localization and

Biopsy Process

6.4 Marker Filling Instructions

We only sell unfi lled 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).

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 8.6 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 fi ll the oil markers outside of the MRI room!

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

Filling Markers

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

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

fi ll the marker with the syringe up to the edge of the marker thread starting at the

bottom of the marker. Rotate the syringe during fi lling to prevent the formation of

bubbles.

cube marker bolt marker marker inside the grid cartridge marker

BI160-GE


Closing Markers

Localization and

Biopsy Process

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

8.6 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 fi ll 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 (fi lled 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 stand them upright in the steam autoclave.

BI160-GE

6

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44

7

Cleaning, Disinfection

and Sterilization

7. Cleaning, Disinfection and Sterilization

7.1 Cleaning

Immobilization and Fixing Device Waterbath

with soft brush if necessary

Needle Blocks and Needle Guides Ultrasound Bath

possibly with pre-cleaning with a

spraying device or water nozzle

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

coil, immobilization and fi xing device as well as the needle blocks and needle

guides must be cleaned as described above. The products used should be

cleaned within 30 minutes after use to minimize the risk of contaminants drying

prior to cleaning. We recommend that the components be cleaned immediately

after the examination/biopsy.

Disassemble the immobilization and fi xing device into its individual parts so that

optimum cleaning can be performed.

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)!

Notice

Pay attention to the cleaning instructions for the High Density

Mamma Coil.

BI160-GE


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.

Immobilization and

Fixing Device

Needle Guides and

Needle Blocks

Cleaning, Disinfection

and Sterilization

Note

dilution duration to disinfect

Bacillol® AF, Bode 5 minutes After each

Company, Hamburg,

Germany

use

Kodan® Tinktur

Forte colorless,

Schülke Mayr Company,

Norderstedt,

Germany

EN1499 Standard

Propan(2)ol 60%

1 minute

1 minute

Each component

at least

5 minutes

(completely

submerged in

solution). Process

can also

be done in ultrasound

bath.

Pay attention to the disinfection instructions for the High

Density Mamma Coil.

BI160-GE

7

45


46

7

Cleaning, Disinfection

and Sterilization

Tip

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).

Throughout the cleaning process, leave the immobilization and fi xing device in

its individual parts so that optimum disinfection can be ensured.

Danger of Destruction!

Improper disinfection may cause malfunction of the device.

Noncompliance with the disinfection instructions may destroy

the system! No warranty service will be provided for damage

caused by improper disinfection.

Danger of Infection!

The instructions for desinfection must be followed.

If the device is inadequately disinfected, the operator and/or

the patient may be infected.

BI160-GE


7.3 Sterilization

Sterilization after each use is only required for the needle guide blocks and the

needle sleeves. After cleaning and disinfection, these parts should be packed

up and sterilized with steam (134 °C, 3.04 bar, 5 min).

Thereafter, the sterilized parts should subsequently be stored in the same manner

as any other sterilized products in your facility.

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.

Tip

Cleaning, Disinfection

and Sterilization

The sterilization agent can cause variations in terms of color.

This has no infl uence on the quality of the product.

BI160-GE

7

47


48

8

Maintenance, Storage

and Waste Disposal

8. Maintenance, Storage and Waste Disposal

8.1 Maintenance

Prior to each use, all components of the BI160-GE must be visually inspected.

Immobilization and Fixing Device Check for breakage or cracks

Needle Guides and Needle Blocks

Defective products must not be used. If defects are found, please contact the

NORAS according to page 55.

Comply with the cleaning, disinfection and sterilization instructions!

8.2 Storage

10°

30°

After use and the requisite cleaning, disinfection and sterilization

(if required), the device should be stored at room

temperature in a dust-free, UV radiation-protected location

(min. 10 °C, max. 30 °C). In the case of re-sterilized needle

sleeves, the maximum storage period (currently 6 months

in single or double packaging in protected storage in dusttight

containers, cabinets, drawers or similar places) must

not be exceeded.

BI160-GE


8.3 Waste Disposal

Maintenance, Storage

and Waste Disposal

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.

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

upon request.

BI160-GE

8

49


50

9 Technical Specifi cations

9. Technical Specifi cations

9.1 Historical Device Data

Designation (Model/Type)

BI160-GE

Manufacturer:

NORAS MRI products GmbH

Leibnizstraße 4

97204 Höchberg

Germany

Regulatory Product Approval

Certifi cates

Operation Type

active nonactive

Product Class / Device Class

I (per MDD Annex VII)

Serial Number

see warranty registration

Product Type / Device Type (according

to UMDNS / DIMDI)

MR-Unit, (16-260)

Supplier:

Operator‘s Manual

First edit 3.3 of July 6, 2009

Test / Control (Time Limits / Type)

Intended Purpose according to information

provided by the Manufacturer.

Year of Purchase

BI160-GE


9.2 Performance Data

Operating Temperature As per the room temperature (air

conditioned) of the MRI room

Storage Temperature Min 10° C / max 30° C

Protection Class I

Weight < 500 g

Dimension Grid

Dimension Positioning Device

Technical Specifi cations

200 mm x 110 mm x 45 mm

200 mm x 110 mm x 45 mm

Materials Peek, Brass, POM

BI160-GE

9

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52

9 Technical Specifi cations

9.3 Parts list

Option 1 - Grid

1 pc. Grid - medial MR10031-GE-M

1 pc. Grid - lateral MR10031-GE-L

1 pc. Needle block set MR10032-10

1 pc. Marker MR10021

1 pc. Operator‘s Manual GA-BI160-GE

Option 2 - Positioning Device (Post&Pillar)

1 pc. Positioning Unit - medial MR10062-GE-M

1 pc. Positioning Unit - lateral MR10062-GE-L

1 pc. Needle guide MR10015-10

1 pc. Needle carriage MR10014-GE-10

1 pc. Marker MR10017

1 pc. Operator‘s Manual GA-BI160-GE

BI160-GE


Declaration of Conformity

DRAFT DRAFT

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

fully complies with the essential requirements of the Council Directive 93/42/

EEC of 14 June 1993 concerning medical devices.

Hubert Noras 04.10.2006

05.06.2007

The Manufacturer

NORAS MRI products GmbH ISO 13485:2003

Leibnizstrasse 4

97204 10. Höchberg Declaration of Conformity

Germany

certifi ed by

TÜV-PS

herewith confi rms in accordance with the conformity assessment procedure of

Annex VII of the Council Directive 93/42/EEC of 14 June 1993 concerning medical

devices that the

BI160-GE Immobilization and Biopsy System for

MRI-supported, mammographic biopsy with the GE

High Density Mammaspule

The System is identifi ed as an non-active medical device in accordance with

Annex IX of the above-mentioned Directive and belongs therefore to Class I,

for noninvasive products.

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

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

Managing Director

BI160-GE

10

53


54

BI160-GE


11. Important Addresses

Important Addresses

Manufacturer (Product Development and Production)

NORAS MRI products GmbH

Leibnizstraße 4

97204 Höchberg

Germany

Phone: +49 931/2 99 27-0

Fax: +49 931/2 99 27-20

E-mail: mri@noras.de

Internet: www.noras.de

Your Sales Partner and Customer Technical Service Organization

In case you do not fi nd the

name of a NORAS sales and/

or customer service representative

here, please contact

NORAS MRI products GmbH.

BI160-GE

11

55


56

12

12. Warranty Scope

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

cleaned, disinfected and sterilized.

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

of the BI160-GE Immobilization and Biopsy System are covered by a

warranty.

Warranty Scope

12 month

A prerequisite for warranty service is that you have handled your BI160-GE

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.

BI160-GE


13. Training Certifi cate

Training Certifi cate

This certifi cate confi rms that the training in the handling and use of the BI160-GE

Immobilization and Biopsy System has been properly conducted.

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

fi elds.

With regard to the hazards of magnetic fi elds, it is absolutely necessary that

you read the Operator’s Manual of the BI160-GE 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

- Cleaning, Disinfection and Sterilization

I have been trained in the handling of the BI160-GE Immobilization and Biopsy

System.

I am aware of the contents of this certifi cate and am familiar with the handling

of the BI160-GE Immobilization and Biopsy System.

Name/Participant Signature

Clinic Ward/Department

Date Technician/Trainer

BI160-GE

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58

14

14. Package

Package

For your information: The packed case

BI160-GE


15. Warranty Registration

Device/Designation: Immobilization and Biopsy Device BI 160 GE

Serial Number:..............................................................................

Warranty Start Date:

Operator:


Section 2:

Warranty Registration

Please send this section to the Manufacturer.

The lower section should be kept in the Medical Devices Log Book

Stamp / Signature of the Authorized Dealer

1. We hereby warrant that the BI160-GE Immobilization and Biopsy System

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

corresponding to state-of-the-art technology for such products for a

period of

12 months

from the day on which said product was delivered to the operator.

2. We are hereby obliged to rectify, free of charge, any damage to the device

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

of the coil.

3. 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

manner not in accordance with its intended purpose. Furthermore, no warranty

service shall be provided if the device has been modifi ed 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.

BI160-GE


60

BI160-GE

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