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 


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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 


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 

1 

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6 

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. 


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. 


7

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. 


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. 


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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. 


The rating plate is located 

on the housing cover. 


The rating plate is located on the bottom 

side of the insertion plate. 


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) 


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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 



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 



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°). 


4 

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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 


4.2.6 Combination with other Devices 


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. 


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1 


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. 


5 

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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 


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. 


5 

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22 

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. 


5.3 Positioning of the Patient Rest 

5.3.1 Head first 

Start-up 


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. 

2

24 

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. 


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. 


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. 


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6 


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. 



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 


6 

2

0 

6 


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 



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. 


6 

1

2 

6 


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 



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) 


6

4 

6 


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 



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 


6 

5

6 

6 


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“ 



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. 


6 

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6 


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 



Space for your notes: 


Process 

________________________________________________________________ 

________________________________________________________________ 

________________________________________________________________ 

________________________________________________________________ 

________________________________________________________________ 

________________________________________________________________ 

________________________________________________________________ 

________________________________________________________________ 

________________________________________________________________ 

________________________________________________________________ 

________________________________________________________________ 

________________________________________________________________ 

________________________________________________________________ 


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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 


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. 



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 


6 

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42 

6 


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. 



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. 


6 

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44 

6 


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. 


Background 


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® 



6.1.5 Post&Pillar Adaptor for Atec® MRI Standard 



6.1.6 Post&Pillar Adaptor for Bard Vacora® 




6 

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46 

6 


Process 

6.2 Grid Fixation Plate 






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. 



Not covering the Insertion plate coil with a sterile tissue may 

lead to infection of the patient. 



Process 


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. 


6 

47

4 

6 


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. 



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. 


6 

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50 

6 


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. 


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. 



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. 


Be absolutely sure to loosen the slat lateral plates and compression 

plates before withdrawing the mamma. 


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 


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

“Cleaning, Disinfection and Sterilization”. 


6 

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52 

6 


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. 



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. 


6 

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6 


Process 

6.2 MRI Mammography 






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). 



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. 


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. 



6.3 Safety Information 


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. 






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. 


6 

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56 

6 


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. 


Cleaning, Disinfection 

and Sterilization 

7. Cleaning, Disinfection and Sterilization 

7.1 Cleaning 

Patient Rest Damp Cloth (moisten with lu- 


kewarm water) 


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)! 


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. 


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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 


use 


Wedge Pad 

Tinktur Forte 

Head Rest 

Immobilization and 

Fixing Device 

colorless, Schülke & 

Mayr Company, Norderstedt, 

Germany 

1 minute 

Needle Guides and 

Needle Blocks 


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. 




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. 


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. 


The instructions for desinfection must be followed. 

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

patient may be infected. 


7 

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7 

7.3 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. 


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. 


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. 


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62 

Functional Tests 



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). 




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 


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64 



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 




- 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. 


65

66 



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 


8.2 Storage 

10° 

0° 

8.3 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. 


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6 


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 


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70 


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 


9.3 Parts List 


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 


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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 


9.4 Options and Accessories 


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® 


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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 



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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 


11. EC Declaration 

Further declarations on request 

EC Declaration 11 


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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. 


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. 


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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 


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. 


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