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Manual BI 320-PA-GE - Noras MRI products

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1. In addition thanks to the slightly tilted design of the patient rest generous cranio caudal access space is available for breast biopsies Additional access space is gained in the rear area for improved operator s manual access by the user NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T produc ts 10 Function The Immobilization Device can be rotated by 360 This ensures optimum access to the lesion ca 270 For guidance a telescopic assembly the Post amp 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 the compression plates and needle blocks Biopsy access is single sided medial single sided double sided lat eral or single sided double sided cranio caudal Image similar 3 1 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 to recognize incorrect adjustments incorrectly read scale values and other operator errors in order to prevent injuries to the patient The control scan procedure is described in Chapter 6 Localization and Biopsy Pro cess and the correct result illustrated in the text NORA
2. Intended Use Indication for Use 2 Intended Use Indication for Use The intended use of the Breast Biopsy 4 Channel Coil BI320 PA GE 1 5T 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 ad oblique images of the internal structures of the female breast When inter preted by a trained physician these images provide information that can be useful in determining diagnosis The Biopsy Unit permits MR guided breast biopsy and wire localization of lesions can be performed by a trained physician NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 8 Intended Use Indication for Use 2 1 Indications e Tumor recognition in the case of unclear diagnoses from other diagnostic pro cedures using contrast agents and their decay times e Breast biopsy i e biopsy from lateral medial and cranio caudal direction 2 2 Contraindication All patient examinations are contraindicated with this system which is also contraindi cated in the proximity of the MRI device according to the information provided by the manufacturer Furthermore the responsibility lies with the examination physician in case of unclear or critical clinical picture Please follow the safety instructions of MRI manufacturer for operators patients and third parties NORAS mrr Breast Bi
3. The bottom array coil is firmly integrated in the patient rest and cannot be removed NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 15 Device Description 4 2 1 3 Patient Pad Coil PPC The Patient Pad Coil PPC which is made of PE foam with a PUR coating skin foam serves as a positioning pad for the patient at the same time The both parts of the coil are connected with the connector plug at the end of the pa tient rest It should be noted that the rotation position of this connector plug is correct NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 16 Device Description 4 2 2 NORAS Biopsy Kit Modular Throughout our modular system you can assemble your biopsy units according to your preferences a What is your preferred Biopsy Method Post amp Pillar with Post amp Pillar Biopsy System lateral medial cranio caudal Higher accuracy compared to grid biopsy Angulation is possible AW O disposable reusable With our Post amp Pillar System lateral medial cc you can perform exact biopsies The needle sleeve is adjustable by 15 or 30 towards posterior or anterior Biopsies can be performed using either reusable autoclavable or disposable sterile Post amp Pillar needle guide sleeves Various height adjustable horizontal and vertical slat plates can be used to fixate the breast NORAS mrr Breast Biopsy 4 Chann
4. Using a too short needle you might not reach the lesion Perform the biopsy in accordance with the instructions of your needle and or vacuum manufacturer After completion of the biopsy clean the device parts as described in chapter 7 Cleaning Disinfection and Sterilization NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 54 Localization and Biopsy Process Danger of penetration through the breast Should under exceptional circumstances the needle be bent while in the breast e g if the needle should strike one of the three horizontal slats after penetrating through the breast clip off the distally deformed needle end with a suitable MR compatible tool and remove the remaining trocar Retraction of the needle with the bent end section would injure the breast Danger of bruising Be absolutely sure to loosen the slat lateral plates before with drawing the breast That way bruises or injuries to the patient can be avoided Danger of injury Before loosening and withdrawing the breast you must remove all instruments If all instruments are not removed you may injure the breast of the patient NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 55 Localization and Biopsy Process 6 1 1 Post amp Pillar Adapter for Ethicon Mammotome MR In application with the Ethicon Mammotome MR Vacuum System we offer a modi fied positioning dev
5. no name 50379 Sep 25 2015 Mag 1 0 5 0thk 0 0ap c W 1495 L 749 The illustration shows that the four coils channels are producing a good quality arti fact free signal Maintenance Storage and Waste Disposal Display of four channels no name 50379 Sep 25 2015 Mag 1 0 5 0thk 0 0ap c W lelo L 605 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 sig nal then a coil may be defective In this case please contact the NORAS MRI prod ucts GmbH Maintenance Storage and Waste Disposal 8 2 Storage Following its use and the required cleaning disinfection and sterilization the device should be stored at room tempera ture in a dust free UV radiation protected location min 10 C max 30 C In the case of re sterilized needle guide 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 e Relative Humidity Min 10 Max 95 e Air Pressure Min 500 hPa Max 1060 hPa 8 3 Waste Disposal All of the materials used in the manufacture of the system components can be con veniently recycled and therefore do not present any particular or unusual hazards during their disposal Prior to disposal the system must be disinfected as
6. 512x5120 70 NEX i SLL Localization and Biopsy Process 4 Mark this line and copy it 5 Scroll through the other slices until you find the lesion that you want to perform a biopsy on In this slice paste the copied line Uptina MRE450w 1 5 Ex 7639 Se 300 Im 104 Ax S527 14E Dec 11 2013 10 33 23 AM Mag 1 0 R M32 VIBRANT 10 TR 7 6 3 6 1 1 50kHz RM 4Breast Moras FL p FOY 36x36 3 0thk 0 05 3600 55 distance 144 2 mm i 512x5120 70 NEX i SLL Localization and Biopsy Process 6 Select the distance tool again and measure the distance between the lesion and the reference line that you copied in step 5 Please note these measurements on a separate piece of paper In this example the Post amp Pillar positioning unit has to be moved 6 mm from the marker zero position to posterior because the patient is lying in the prone position Uptima MR4ASOmw 1 57 x 7639 Se 300 Ae LOI Ax S27 14L Dec 11 2013 10 33 23 AM Mag 1 0 k M30 AVIBRANT 10 TR 7 0 3 6 ciii 50kHz EM 4Breast Moras FL p FOW 36x36 3 0thk0 0SH distance ldir Mi oN 36 00 55 4 distance 6 0 mm 3 51 2e 5120 70 NEX Localization and Biopsy Process 7 In order to determine the shift from head to feet Post amp Pillar positioning unit to the left or to the right view the slice position of the marker and lesion at the trans versal slices 8 The lesion you have c
7. Grid 5 4 3 Closing Markers You can close the Post amp Pillar Marker the Grid Marker Block or the Bolt Marker by hand Post amp Pillar Marker Grid Markerblock 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 use only MR compatible screwdrivers If no MR compatible screwdrivers are available you must fill the oil marker outside of the MR room NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 99 Start Up 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 lf the marker cannot be imaged as a straight line then change the phase code direc tion during imaging and verify the changed settings 5 4 4 Emptying Markers Markers must be emptied prior to sterilization To empty them open the markers as described above and empty them Caution Marker liquid is harmful see warning in struction 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 Health hazard for operator
8. Grid Method with Grid Biopsy System Height Adjustable lateral medial cc disposable Perform several biopsies or wire placements at various lesions in one step EN disposable reusable The two Grid Biopsy Units Height Adjustable lateral medial cc disposable offer a cost effective alternative for a lateral medial and cranio caudal breast biopsy applica tion The low priced disposable grids reduce autoclavable costs and improves patient throughput The height adjustable design guarantees best access Biopsies and wire placements can be performed by either reusable autoclavable or disposable ster ile grid needle blocks Before use the sterile disposable grids must not come into con tact with unsterile or contaminated components Before using the sterile disposable grid the instructions for use must read in full and with care The sterile packaging and the instruments must be checked for proper condition NORAS mri Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 20 Device Description The sterile disposable grid is for single use only it is not resteri lizable and must be properly disposed after use Only qualified personal should use sterile disposable grid Please always wear protective gloves and carefully comply with the application times for Hepatitis B and HI viruses See the instructions for use of the respective disinfectant solu tion b Modular NORAS Biopsy Unit
9. Marker liquid is harmful Please note the warnings NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r odu C ts 36 Localization and Biopsy Process 6 Localization and Biopsy Process The biopsy procedure is based upon the safety concept described in chapter 3 Function Compliance with this concept is mandatory Permanent damage to the system The fixation screws should be removed from the basic unit fixa tion plate during medial application In case of a higher load on the patient rest a damage of the screws could not be excluded When using the grid as a medial application the fixation screws must not be mount ed The screws are only necessary as additional fixation of the grid for the lateral ap plication The medial grid is always mounted in the lowest possible position It is suf ficiently fixated with the ball catch The fixation screws are part of the standard delivery of the basic unit fixation plate The basic unit fixation plate can be used both lateral and medial Using the grid in lateral position it can be moved in 10mm steps up to max 30 mm in posterior direc tion Only with this application the screws are necessary for a safe fixation NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 37 Localization and Biopsy Process 6 1 With Post amp Pillar Biopsy System Permanent damage to the system The system may only be assembled by trained medical
10. Channel Coil BI 320 PA GE 1 5T products Applicable only for Biopsy Set consists of Base Plate Fixation Plate lateral medial Slate Plate vertical amp horizontal Curved Slate Plate vertical amp horizontal Post amp Pil lar Positioning Unit Post amp Pillar Marker Needle Guide Sleeve Set Grid Localization Needle Block Set Grid Markerblock Blocking Plate Autoclave Box Needle Guide Post und Pillar Adapter for Ethi con SenoRx ATEC Vacora Grid Needle Block Adapter for Ethicon SenoRx ATEC Vacora 80 Cleaning Disinfection and Sterilization 15 minutes and rinse by water the quality of water must be at least equal to drinking water better would be using aqua Demineralized wa ter Changing in color due to con tinuous disinfection cannot be ex cluded but can be largely prevented by sufficient rinsing after each use The solution is distributed on the surfaces by a fluff free cloth The disinfectant permeates the dirt parti cles and because of mechanical forces pressure abrasion this en sures effective cleaning Additional ly the wiping motion ensures that spores which are resistant to the disinfectant will be removed The cloth must be replaced after the dis infection in order to prevent the spreading of the spores on other areas Moreover it is essential that the wiping solution is renewed regu larly daily Danger of destruction The coils
11. SenoRx EnCor Please follow the instructions of chapter 6 1 With Post amp Pillar Biopsy System and the operator s manual of your vacuum biopsy gun 6 1 3 Post amp Pillar Adapter for Suros ATEC al Please follow the instructions of chapter 6 1 With Post amp Pillar Biopsy System and the operator s manual of your vacuum biopsy gun Please follow the instructions of chapter 6 1 With Post amp Pillar Biopsy System and the operator s manual of your vacuum biopsy gun 6 1 4 Post amp Pillar Adapter for Bard Vacora Please note regarding from chapter 6 1 2 until 6 1 4 When using our needle guide sleeves 18 14G or the custom made 11G needle guide sleeve the Post amp Pillar Marker is to be disinfected and does not have to be auto claved The needle guide sleeves need to be sterilized autoclave method or similar Please see chapter 7 Cleaning Disinfection and Sterilization When using a vacuum gun in combination with our Post amp Pillar adapters the Post amp Pillar marker has to be sterilized according to our sterilization instruction When using a steam autoclave please follow the Post amp Pillar marker instruction for sterile filling It is recommended to perform the adjustment of the coordinates with both the needle guide contained in the set and the inserted Post amp Pillar marker After setting the height adjustment note the adjusted height In order to place the cannula for puncturing
12. about the effective life time is not possible because there is no data basic for statisti cal evaluation All further products made of plastic the influence parameters are especially the re processing and the mechanical wear of moving parts The treatment process can lead to a discoloration of the materials but this has no influence on the material properties and product life Mechanical wear is dependent on the frequency of application and for the above mentioned reasons it cannot be assessed quantitatively Safety Take into account the intended use and specified warnings in the manual as well as performing of visual inspection for all components before using the product on the patient Please follow the safety instructions of MRI manufacturer for operators patients and third parties NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 6 General Information Prescription use only Country specific laws restrict this device to sale by or on the or der of a physician or with the descriptive designation of any oth er practitioner licensed by the law of the country in which he practices to use or order the use of the device This device may only be distributed to persons who are licensed practitioners or to persons who have a prescription or other order from a licensed practitioner to purchase it NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 7
13. and vertical direction to zero see ill below NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 40 Localization and Biopsy Process Marker in the center of the device Set angulation an gle guide base and telescope bar to O position Figure above Needle guide on zero position with marker on the right Now mount the Post amp Pillar positioning unit onto the pins of the fixation plate NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T produc ts 41 Localization and Biopsy Process NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T produc ts 42 Localization and Biopsy Process a Manually calculation of coordinates for the MR supported breast biopsy with the NORAS Post amp Pillar Biopsy Unit on GE MR systems 1 Perform a measurement with transversal slices and look for the slice where you can see the marker 0 Ex SEI SU A UF Ax 2 94 M30 AVIBRANT 10 TR 7 6 4 6 ciii 50kHz EM 4Breast Moras FL p FOW 36x 36 3 0thk 0 05 3600 55 512x5120 70 NEX i HLL Localization and Biopsy Process 2 Start the distance tool 3 Draw a line straight through the pointer Optima MRA5Om 1 57 Ex 7639 Se 300 Im 204 Ax 24 94 Dec 11 2013 0 33 23 AM Mag 1 0 MS0 AVIBRANT 410 TR 7 6 3 6 Cr1 1 SOkHz RMi46reast Noras FL p FO 36x36 3 0thk 0 0sp 36 00555 distance l44 2 mm i
14. between the skin and the lesion using your toolbox Abstand Distance NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 67 Localization and Biopsy Process e Push the needle block with the desired diameter 12G 14G or 18G into the corre sponding opening in the compression plate and using the toolbox determine the desired penetration point on the needle block e Select the needle block with the proper size needle and mount these in the calcu lated position Select a needle with an appropriate length to reach the lesion Con sider to add the offset an approximately 25 mm to the distance skin lesion Insert the needle to a position approx 10 mm in front of the lesion e If possible needle diameter to be considered set a local anesthesia using the block slot that has been determined Remove the needle block and apply an addi tional anesthesia if necessary This may be done using a bigger needle by slightly cutting the tissue with a sterile scalpel Especially with lesions close to the surface this might be very important to avoid a delocalization NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 68 Localization and Biopsy Process e When replacing the needle block place the cannula and remove the trocar After the control scan the wiring or removing of tissue may be performed Please make sure no artifact is notable when using plastic cannulas and removi
15. breast tissue as possible is held between the medial slat plate and the lateral grid e Insert the marker block supplied into the grid fixation plate NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 64 Localization and Biopsy Process Medial Lateral Anterior e Detect the marker block and the lesion in the MRI using sagittal slices e Mark the lesion with a permanent auxiliary point from the software toolbox of your MRI system e Copy paste the point into all slices e Go to the outer lateral or medial slice and look for the grid indentation the indenta tion is best viewable when sufficient tissue is placed into the square grid holes e Search for the copied point and the marker block pointer e Replace the marker block into the grid hole where the marked point is viewable NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 65 Localization and Biopsy Process Marker verschieben Marker block to be relocated e After the axial or coronal scan the layer of the lesion and marker block can be veri fied in order to determine the exact puncture hole e In general it is sufficient to be close to the lesion when inserting a localization wire NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r odu C ts 66 Localization and Biopsy Process e When the marker block and the lesion are in the same plane determine the dis tance
16. exchange the guidance bracket with the inserted Post amp Pillar marker against the sterile adapter without Post amp Pillar marker A control scan the tissue sample can now be taken NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r odu C ts 60 Localization and Biopsy Process Please make sure that when using plastic cannulas that no artifact is noted after re moving the trocar Close the cannula with the provided accessory plastic stick after removing the trocar The plastic stick is then to be removed and the puncture or wire localization can be performed through the cannula 6 1 5 Multi Purpose Needle Hub Assembly Beside the conventional needle carrier you can also use a sterile disposable needle guide Multiple Hub Assembly from Invivo The Multiple Hub Assembly will be held in the guidance bracket MR10014 MHA and will be fixed with twist on connector The Multiple Hub Assembly can be used with all biopsy needles distributed by NORAS MRI products GmbH Guidance bracket Multi Purpose Needle Hub Assembly NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 61 Localization and Biopsy Process 6 2 With Grid Biopsy System Permanent damage to the system The system may only be assembled by trained medical person nel Incorrect assembly and operator errors made by untrained per sonnel can permanently damage individual parts of optional components and of the devic
17. person nel Incorrect assembly and operator errors made by untrained per sonnel can permanently damage individual parts of optional components and of the device itself Training of personnel The users must be trained before using the device detailed training of the personnel for existing components G20 G40 In the following the localization process with medio lateral alignment of the fixation unit lateral access and the use of axial slices is described The description applies for the use of the system with the Post amp Pillar Biopsy System for the examination of a single breast NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pro ducts 38 Localization and Biopsy Process Medial and lateral access Push the fixation plate with the medial slat plate onto the shorter raster bars of the base plate Ref 111292 as far as it goes Slide the second fixation plate with the curved slat plate onto the longer raster bars of the base plate marked Lateral CC up to the stop Insert the base plate into the round pits of the insertion plate of the patient rest After aligning the complete fixation unit in medio lateral direction slide the fixation plate until the end of the raster bars The fixation unit is now open as far as possible For medial access insert the blocking plate into the patient rest of the side of the breast which is not to be biopsied Now position the patient on the patient res
18. the slat lateral plates on the variable position bars in such a way that the patient can lie as comfortable as possible during the entire examination e Ensure that as much breast tissue as possible is held between the slat lateral plates e Use the toolbox of your MRI system to determine ROI FOV and type of sequence e Perform the MR mammographic procedure Danger of bruising Be absolutely sure to loosen the slat lateral plates before with drawing the breast To do so simultaneously push the left and right slides and pull the lateral slat plate outwards That way bruises or injuries to the patient can be avoided NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 73 Localization and Biopsy Process 6 4 Safety Information Please consider the following when using the Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T Damage to the coils When transporting the insertion plate coil carry it only by its housing not by its cables Never carry the patient pad coil by its loops and do not bend it Connection cables must not be bent or knotted Defective coils including their cables shield traps and plugs must not be used Permanent damage to the system The system may only be assembled by trained medical person nel Incorrect assembly and operator errors made by untrained per sonnel can permanently damage individual parts of optional components and of the device itself NO
19. 0 PA GE 1 5T pr odu C ts 99 Technical Specification Suitable for all NORAS Post amp Pillar Biopsy Units Guidance Bracket PEEK for Invivo Disposable Needle Guidance Disposable Needle Guidance 113692 Multi Hub Assembly not for 7G MR10062 MHA 9 4 5 General inn Mian Blocking Plate 111319 A blocking plate to raise the alter ON nate breast is required for medial biopsies Operator s Manual BI 320 PA GE 118309 Bodily injuries due to accessories When using accessories please always observe the manufactur er s instructions NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 100 Important Addresses 10 Important Addresses Manufacturer product development and production NORAS MRI products GmbH Leibnizstrasse 4 97204 Hoechberg products Germany Telephone 49 931 2 99 27 0 Telefax 49 931 2 99 27 20 E Mail mri noras de Internet www noras de NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T produc ts 101 Operator Training Outline 11 Operator Training Outline have reviewed the Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T Training Outline and understand the topics discussed and verify that the training outlined is complete The training delivered was reflective of the details in the Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T user manual will read or have read this appropriate manual including the Cleaning a
20. 33 23 Ak Ai Hag Brustwand di Bru stwarze SOKHZ RM 4Breast Horas FL p FOW 36 46 3 0tThKA0 05p 1 distance 144 2 mm angle 849 8 36 00 255 distance 6 0 mm angle 51285120 70 NEX i SLL Localization and Biopsy Process 15 Draw the second line with an angle of 15 degrees from left to right This can also be done slightly underneath the first line 16 The second line has to have appropriate length toward the right so it lasts at least underneath the pivot point of the Post amp Pillar marker You can also extend that line afterwards by pulling its right endpoint Uptima MR4A5SOmw 1 57 Pies xI 76039 Ser ef 0 Dec 11 2013 P 10 42 22 AM H Hag 1 0 Winkel 15 oder 30 inkel auf Befund verschieben Abstand von Pointer zum Winkel messer 22 mm vom Ende des Pointers Hautabstand messen R 6 H3D VIBRANT 10 TR 7 6 TE 3 6 EC 1 1 50kHz RMi4Breast Noras FL p FOW 36 36 2 distance 21 8 mm i 3 OThE 0 05p o 36 0055 4 distance 11 3 mm 51245120 70 NEX w Ln Localization and Biopsy Process 17 Now go ahead and move the second line which forms an angle of 15 degrees with the first line so that it has its left endpoint in the center of the lesion Then left click the second line Finally hold down the left mouse key and move the line 18 Choose the distance tool und draw the new line with a length of 22 mm from the tip of the marker to the back where th
21. 6 2 6 2 1 6 2 2 6 2 3 6 2 4 6 3 6 4 8 1 8 2 8 3 9 1 9 2 9 3 9 4 9 4 1 9 4 2 9 4 3 9 4 4 9 4 5 10 11 Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T Content With Grid SIO SY oy SIG Mi ee iacccuaiescqesceesneacesncenciceaic encesdeanqsuciansmencasacanncunaeenseens 62 Grid Needle Block Adapter for Ethicon Mammotome MR 0 0000 71 Grid Needle Block Adapter for SenoRx ENCor cccccecccessesseeseeseeeseereeeees 71 Grid Needle Block Adapter for Suros ATEC oo cecccceecccecccereereesecereereeees 71 Grid Needle Block Adapter for Bard Vacora ccccccccssesecessereeeseereeeseereesees 72 IVES AIMIOOTADY aciccccccacaseacunsasmanensqaeaeincueacseeeninsceesaanaeseraiessemanieaseeceancasecaies 72 DALSLY IMTORIMANION senose re EEE EE EEE E I EEEE EE 14 Cleaning Disinfection and SteriliZation cccccsceceeseeeeeeeeeseneeeeeeeeenees 76 Maintenance Storage and Waste Disposal cccccseceeeeeeeeneeeeeeeeenes 86 NANEN ICO se a EE R EE E EE EA AE OA 86 LORS ace nsrotecntao shea bse E Maaaaanoiaooaeoan 91 wane BS ele ci a E EE E E E EE E 91 Technical Specification ccccccceeceeeceeeeeeeeseneceeseneoneeeesensenesensoneneeseneees 92 FUSION Gal DEVICE Dalasi e EE SE E sie eens 92 Performance Data ccccccceccsscceeceeeseeteeeeeeteeseeeeseceeeeeeteeteeeegeteeeeeeeeteeenaess 93 PAS L E E E E naereanensernenenanpnenenaeananeens 94 Options and Accessories a vsinsinisi
22. Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T 117693 for Immobilization and MR supported Mammography with the NORAS 4 Channel PIC Breast Coil System and PA320 Patient Rest ae oa LL 7 lt L T O N ap wa i O C z 4 Ee af JT gt T Q 2 aa o 4 aD C m Operator s Manual Revision 03 NORAS mr ae Products Tecnica changes reserved Date issued August 2015 NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 2 Content Content 1 General Informa tlO es a a a 5 2 Intended Use Indication for USe cc ccceceeceeeeeeeeeeeeeeeseneeseeeeeeeneeenesees 8 2 1 PVG QUO Ses cdeas sang E ge oreo ne euse on dae A EAA EA E AE 9 2 2 Contraindication sire tesen ve inaeinarnanicavsanviaeeianeiierieantanviadeinesiweerarinaeiaindeianiwasione 9 3 FONCION ose sie ice AEO 10 3 1 Sde 0 9 8 ame ant ete anne ee ean ee eee 11 4 Devi DOSS ECO Dia orninan a a aaa a 12 4 1 Definitions and 5 VIMDONS essorer En NENEA ERS 12 AT RN PINOS eee E A E RR eee ee 14 4 2 SVS CN COMPONEN orana E E A EAE E AE 15 4 2 1 Patient Rest with Breast Cushion and Head Rest ccccceseeeeeeeeeeeeeees 15 42 2 NORAS Biopsy KIC IMOGUIAR eicosonsvesevasavdcavastewewndulerosenedensdenedesscdenedenademadenesewed 17 4 2 3 Accessory Cranio caudal Fixation Unit CC 320 PLUS eee 23 4 2 4 Combination with other De VICES ccccccecceeceeceeeeeseeeeeeeeeeaeeeee
23. RAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 14 Localization and Biopsy Process In order to enable reliable navigation the marker must be displayed in the MRI image as a Straight line If the marker is imaged with a kink or offset similar to that shown in the adjoining illustration repeat the image with a reversed phase code direction NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 75 Cleaning Disinfection and Sterilization 7 Cleaning Disinfection and Sterilization WARNING The procedure must be followed as described In case of inadequate cleaning disinfection or sterilization you carry the risk of infection Non compliance with the cleaning instructions may destroy the system No warranty service will be provided for dam ages due to improper disinfecting Please always wear protective gloves and carefully comply with the application times for Hepatitis B and HI viruses See the instructions for use of the respective disinfectant solution Limitations on re Frequent processing can have an impact on these prod processing ucts color changes but do not affect the function of the product Frequent processing can have an impact on these products col or changes but do not affect the function of the product Please always wear protective gloves and comply with the appli cation times for Hepatitis B and HI viruses See the instructions f
24. S mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 25 Start Up 5 Start Up 5 1 General Information Device damage coil error Do not bend the patient pad coil Never carry the patient pad coil by using the loops as handles To release the patient pad coil from the patient rest do not pull at the coil loops There is a risk of damage to electronic compo nents and thus the total failure of the breast coil Device damage coil error Only trained personnel may be assigned to handle the Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T Operating errors may cause permanent damages to the de vice coil Bodily injuries Only trained personnel may be assigned to handle the Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T G19 G33 Operating errors may cause bodily injuries e g contusions to the user and or patient NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 26 Start Up Danger of infection Prior to start up of the devices or parts thereof all components must be treated as described in chapter 7 Cleaning Disinfection and Sterilization Non compliance with the above instructions may lead to infection of the patient 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
25. S mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 11 Device Description 4 Device Description 4 1 Definitions and Symbols The following symbols are used on the Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T and in this operator s manual M ISO 7000 2497 Date of Manufacture Operator s Manual EN ISO 7010 Differ to the requirements of EN ISO 701 M002 M002 all laser engravings can only be exe cuted in grey instead of blue due to tech nical unfeasibility ISO 7000 0434B Caution read the accompanying documents Waste products should not be disposed of with household waste e g at a local authority collection point Directive 2002 96 EC ISO 780 DIN 55402 ISO 7000 0621 Fragile handle with care oe ISO 7000 0626 Store in a dry place ISO 7000 0632 Temperature Limit ISO 7000 2498 serial Number DIN EN 980 5 10 ltem Number NORAS mrr This way up Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T produc ts 12 Device Description IEC 60417 5172 Protective Insulation IEC 60417 5333 Do not touch Conforms to the essential requirements of Council Directive 93 42 EEC of 14 June1993 concerning medical devices Warning regarding risks that may result in minor physical injury or material damage Warning regarding risks that may result in death or serious physical injury Information regarding the optimal use of the product On the following page we descr
26. The Post amp Pillar adapters are attached to the guide base and can thus serve as a needle guide The adapters are indicated in Chapter 9 4 Options and Accessories The Mammotome MR Biopsy System from Ethicon Endo Surgery Inc FDA K042753 can be used with a special adaptor For more information see Chapter 6 Localization and Biopsy Process Upon request suitable adapters for your system can be manufactured Combination with other devices The Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T may only be used in combination with the above named devices and coil as well as accessories supplied by 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 NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 24 Device Description Bodily injuries due to accessories Please follow the instructions of the accessory manufacturer In case of biopsy needles note in particular the authorization of the field strength of the used MRI and the correlation of needle di ameter and needle guide needle block and an adequate needle length for the planned biopsy see also Chapter 6 Non compliance with theses instructions may lead to bodily injuries of the user or patient Bodily injuries due to accessories When using accessories please always observe the manufactur er s instructions NORA
27. ammo Biopsy System the NORAS company of fers reusable needle block adapters made of PEEK These ensure the compatibility of the SenoRx EnCor Biopsy System EnCor cannulas and probes with 7G 10G and 12G with the NORAS grids The positioning process is described in chapter 6 2 After the successful positioning process of the needle block adapter and the control scan please follow the SenoRx EnCor Biopsy System manual in order to accom plish the biopsy procedure i a 6 2 3 Grid Needle Block Adapter for Suros ATEC E For use with the Suros ATEC Biopsy System the NORAS company offers reusable needle block adapters made of PEEK These ensure the compatibility of the Suros ATEC Biopsy System cannulas and probes with 9G with the NORAS grids The positioning process is described in chapter 6 2 After the successful positioning pro cess of the needle block adapter and the control scan please follow the Suros ATEC Biopsy Systems manual in order to accomplish the biopsy procedure NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T produc ts 71 Localization and Biopsy Process os L For use with the Bard Vacora Vacuum Biopsy System the NORAS company offers reusable needle block adapters made of PEEK These ensure the compatibility of the Bard Vacora Vacuum Biopsy System cannulas and probes with 10G with the NORAS grids The positioning process is described in chapter 6 2 After the success ful positioning proc
28. ate the breast Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T produc ts 22 Device Description 4 2 3 Accessory Cranio caudal Fixation Unit CC 320 PLUS Ref 118341 In order to immobilize one or both breasts in cranio caudal direction at the same time you will need the Cranio caudal Fixation Unit developed by NORAS This ac cessory is optionally available at NORAS The Cranio caudal Fixation Unit consists of one base plate two pressure plates left and right with breast cushions which enables through the guidance bar and the af fixed handle bars the fixation The proper adjustment is achieved by two locking SCrews Guidance Bar Pressure Plate Left Pressure Plate Right l Locking Screw Breast Cushion Handle Bar for CC Base Plate NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 23 Device Description 4 2 4 Combination with other Devices The coil system of the Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T can be used with the following MRI systems gt 1 5T GE Optima MR450W Special NORAS adapters are available for the use with Bard Vacora Suros ATEC und SenoRx EnCor 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
29. crannsdsendinnsadbannsdimandondinnaanndiduanmeaiouenendianaanaaiods 95 Compilation of the Biopsy System ccccecccecseeeceeeceeeceeeseeceeeseeeseeeseeeaes 95 Accessories for Post amp Pillar Biopsy System c cccceccceeeceeeeeeeseeeeeeeeees 95 Accessories for Grid Biopsy System cccccecccececeeeeeeseeeseeeseeeseeeseeeseeeeees 97 NORAS Adapter for Vacuum GUNS ccccceceeecseeceeeseeceeeeeeeeeteeeaeeeeeeeeenaes 99 Ec e E E ee ee E 100 Important Addresses a annnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnn 101 Operator Training Outline a nannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnne 102 NORAS mnrIi products 4 General Information 1 General Information A prerequisite for safe and trouble free operation is the proper observance of instruc tions in particular the following points The coil system of the Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T can be used with the following MRI systems gt 1 5 T GE Optima MR450W The patient rest is designed for a permissible maximum patient weight of up to 135 kg Maximum allowed patient weight The maximum permissible patient weight may not be exceeded of 135 kg Before examination with patients it is recommended to train on the phantom in order to be familiar with the system To receive information about new developments or accessories for your Patient Rest with Immobilization an
30. d Biopsy System please send an e mail with the serial number of your coil to mri noras de or go to www noras de The application conditions have a major impact on product life Since these condi tions can vary greatly from user to user an estimate of life time is not possible The most important factors in influencing product life are the frequency of application and processing method cleaning disinfection and sterilization Especially for flex coils the frequency of use and the type of application extreme bending radius depending on the position of the examined body part have the major influence on the life of the foam covered as well as inside flex printed circuit board s NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pro duc ts d General Information An exemplary test with the Patient Pad Coil PPC of the Breast Coil has demon strated that after 3000 bending cycles and a 60 degree range of deflection upwards and downwards the coil still works in accordance with the specifications Assuming of 4 applications per working day 200 days per year the result for this test is a calculated value of almost 4 years of application without damage of the coil This however is only a theoretical statement and has no representative character In case of rigid coils the main influence on life time is the reprocessing Especially the use of plasma sterilization procedures reduces the lifetime considerably A statement
31. d with unfilled markers The number of markers required de pends 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 instructions 5 4 1 Opening Markers Open the Post amp Pillar Marker the Grid Marker Block or the Bolt 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 use only MR compatible screwdrivers If no MR compatible screwdrivers are available you must fill the oil marker outside of the MR room Post amp Pillar Marker Marker Bolt Marker with Grid Cartridge Marker and Grid Marker block NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 34 Start Up 5 4 2 Filling Markers The markers must be filled with diluted MRI contrast agent to make them visible in the 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 Grid Markerblock Marker Bolt Marker inside the Cartridge Marker
32. described above to eliminate any risk of infection Following their final use the patient pad coil and the frame breast coil should be re turned to the manufacturer for disposal We would be happy to provide you with additional information about disposal upon request NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T produc ts 91 Technical Specification 9 Technical Specification 9 1 Historical Device Data Designation model type Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T 117693 Manufacturer NORAS MRI products GmbH Leibnizstrasse 4 97204 Hoechberg Germany Operation type non active DX active Product class Device class lla per MDD annex IX chapter Ill clause 3 paragraph 3 2 rule 10 Identification number of notified body CE marking 0123 Product type Device type accord ing to UMDNS 7 DIMDI Surface coil MR 17 542 Supplier NORAS MRI products GmbH Leibnizstrasse 4 97204 Hoechberg Germany Test Control time limits type Intended purpose according to in formation provided by the manufac turer The device is intended for use during the MRI examination of the female breast Biopsies can also be made with the system NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T products 92 Technical Specification 9 2 Performance Data Operating temperature Corresponding with the air conditioned room temperature o
33. e itself Training of personnel The users must be trained before using the device detailed training of the personnel for existing components G20 G40 The localization process with medio lateral alignment of the fixation unit lateral ac cess and the use of the sagittal slices is next described This applies for the use of the system with the grid for the examination of a single breast In the case of the simultaneous biopsy of both breasts lateral access use a second fixation unit and a second grid on the other side and proceed in the same way NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 62 Localization and Biopsy Process Medial and lateral access Push the fixation plate with the disposable medial grid plate onto the shorter raster bars of the base plate Ref 111292 as far as it goes Slide the second fixation plate with the disposable lateral grid onto the longer raster bars of the base plate marked Lateral CC up to the stop Insert the base plate into the round pits of the insertion plate in the patient rest After aligning the complete fixation unit in medio lateral direction slide the fixation plate until the end of the raster bars The fixation unit is now open as far as possible For medial access insert the blocking plate into the patient rest of the side of the breast which is not to be biopsied Now position the patient on the patient rest and immobilize the brea
34. e pivot point of the mechanic is located 19 With an additional line measure the distance from the pivot point on the marker 22 mm behind the tip to the line with 15 degrees angle This is the amount you need to move the Post amp Pillar positioning unit 20 After movement and angulation of the marker perform a control scan in order to check that the marker points at the lesion Now determine similarly to step 11 the puncture depth from the skin surface to the center of the lesion 21 After the puncture with the trocar perform another control scan in order to check that the end of the cannula lies right in front of the lesion The further biopsy may then be carried out by authorized personnel NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r odu C ts 53 Localization and Biopsy Process Control scan shows large or no image distortion Please pay attention to removing the metal trocar when inserting the cannula When using a plastic cannula the metal trocar has to be replaced by the provided plastic stick Needle penetration at incorrect location Please take care of using a needle with the appropriate size gauge as well as the corresponding needle guide sleeve In case of extreme small needle sizes the lesion may be missed In case of extreme large needle sizes there is a risk of damage to the needle Insufficient penetration depth Please take care of using a needle with the appropriate length
35. ed and released by the Robert Koch Institute RKI can be used in accordance with the instructions on their labels Procedure 1 Load components such that hing es are open and cannulations and holes can drain For needle blocks and needle guides a pre cleaning by means of syringe or water jet may be necessary 2 Run cycle minimum 5 minutes clean and 5 minutes rinse 3 When unloading check cannula tions holes etc for complete removal of visible soil If necessary repeat cycle or use manual cleaning NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T products Applicable only for Biopsy Set consists of Base Plate Fixation Plate lateral medial Slate Plate vertical amp horizontal Curved Slate Plate vertical amp horizontal Post amp Pil lar Positioning Unit Post amp Pillar Marker Needle Guide Sleeve Set Grid Localization Needle Block Set Grid Markerblock Blocking Plate Autoclave Box Needle Guide Post und Pillar Adapter for Ethi con SenoRx ATEC Vacora Grid Needle Block Adapter for Ethicon SenoRx ATEC Vacora Cleaning Disinfection and Sterilization Disinfection auto mated All parts can be dis infected by machine the exception cases are coil cables and plugs patient rests patient pad coils PPC bottom array coil FBC breast cushion head rest vacuum mattresses Breast Biopsy 4 Channel Co
36. eeeeeeeneeees 24 5 oel aa E o EE E roe ee reer tr rrr rrr rer crete rr ter reer nt rere rr rr rer err rer cr 26 5 1 Genera TOO eaea EE E E EEEE E EE 26 9 2 Piug n ANG unplugging CONS gioco specu sz sedcenencanonanasanondsasaseaddenanosdatwanendaenerabaana 29 5 3 Positioning of the Patient ReSt cccccccccccecceeeeeeeceeeseeeseeeseeeeeeseeeeeeeseeees 32 Io FEGT FIE oa E E EEE E EEE 32 5 4 Nakor FINNO MNEC UON S aire r Ee E E E EEE E 34 DA Opning WANK ENS ecectencedecszsaseecarsesesasrsansnaneseresenssesnsesseasaedenneressennenescesnceesncen 34 DAL PMO ACL aeee i eA S AE EAE ENEE AEE AEE AEAEE 35 ISF CO NO MAIKO aeae E E ET 35 SAA EMMOVNO Bool ee 36 6 Localization and Biopsy ProcesSS ccccceseeseceeeeeeeeneeeeseneceeseeseneeeeseeeones 37 6 1 With Post amp Pillar BIOPSY SYSTCM sccncsescszszezcceccesssessdesesasceaseserenens nese secu diirai 38 6 1 1 Post amp Pillar Adapter for Ethicon Mammotome MR 0 cc cccccesccerseereeeeeeee 56 6 1 2 Post amp Pillar Adapter for SenoRx ENCor ccccccceccceccerceeceseerecereeseeereereeees 60 6 1 3 Post amp Pillar Adapter for Suros ATEC ooo ceccecececececesecerecereeseeerecereeereee 60 6 1 4 Post amp Pillar Adapter for Bard Vacora ccccccccsceceseceercecsceseesecereeseeereeneeen 60 6 1 5 Multi Purpose Needle Hub Assembly ccccccccccsecseeeeeeeeeeeeeeeeeeeeeeaeees 61 Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T NORAS mrr products
37. el Coil BI 320 PA GE 1 5T p r O du C ts 17 Device Description Grid Method with Grid Biopsy System lateral medial cc Perform several biopsies or wire placements at various lesions in one step EN disposable reusable The Grid Biopsy System lateral medial cc like all grid solutions allows multiple biopsy access points within a single procedure It is possible to perform biopsies from all sides The unit can rotate 360 in 15 increments Grid needle blocks can be freely positioned in the grid to ensure needle guidance The cubes are available as reusa ble autoclavable or disposable sterile accessories NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 18 Device Description Grid Method with Grid Biopsy System Height Adjustable lateral Perform several biopsies or wire placements at various lesions in one step R disposable reusable The Grid Biopsy System Height Adjustable lateral guarantees ideal lateral access In particular areas close to the thorax can be well targeted with this grid solution A grid needle block set consisting of 18G 14G and 12G tubes is available as reus able autoclavable or disposable sterile version The fixation of the breast is done through the grid on the lateral side and horizontal or vertical slat plates on the medial side NORAS mrr products Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T Device Description
38. ess of the needle block adapter and the control scan please fol low the Bard Vacora Vacuum Biopsy System manual in order to accomplish the bi opsy procedure 6 2 4 Grid Needle Block Adapter for Bard Vacora 6 3 MR Mammography Permanent damage to the system The system may only be assembled by trained medical person nel Incorrect assembly and operator errors made by untrained per sonnel can permanently damage individual parts of optional components and of the device itself In the following the mammographic imaging process with the medio lateral alignment of two fixation and immobilization devices for the simultaneous diagnosis of the left and right breast is described e 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 medio laterally on both sides laterally with the curved slat lateral plate supplied also horizontally for possible improved patient comfort NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 72 Localization and Biopsy Process During the examination some parts of the breast may come into contact with the surface of the base plate with the low probability Before each examination of the patients the base plate must be covered with a clinical cloth e Position the patient on the patient rest and immobilize the breast to be examined by pressing
39. f the MRI room Storage temperature Room temperature Weight Approx 10 kg according to accesso ries Dimensions 714 x 470 x 196 mm Interfaces Electrical GE MRT Mechanical MRT Patient Rest Maximum operating time of coils Continuous operation Field of view maximum 160 mm x 320 mm x 160 mm NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r odu C ts 93 Technical Specification 9 3 Parts List Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T 117693 Patient Rest 117720 Breast Cushion 114971 Head Rest 117758 Patient Pad Coil for GE 1 5T 117721 NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 94 Technical Specification 9 4 Options and Accessories 9 4 1 Compilation of the Biopsy System pemon nin Base Unit for all NORAS BI320 112663 Biopsy Systems Post amp Pillar Biopsy System 111449 lateral medial cranio caudal k Grid Biopsy System lateral me 111456 dial cranio caudal Grid Biopsy System Height Ad 112658 justable lateral Jaa 9 4 2 Accessories for Post amp Pillar Biopsy System pemon m Post amp Pillar Positioning Unit 111259 with Telescope Bar autoclavable i and reusable Material PEEK Post amp Pillar Needle Guide auto 111451 clavable and reusable Material PEEK able to be angulated by 15 and 30 Post amp Pillar Marker autoclava 111300 ble and reusable Material PEEK remove marker l
40. ff free mois tened cloth Due to possible ma terial incompatibility abrasive cleaners or other organic sol vents and solvent based cleaning agent e g benzene alcohol stain remov ers may not be used Detergent Example Sekusept PLUS Ecolab 4 0 vol Korso lex Plus 3 0 vol with exposure time of 15 minutes For this pur pose all aldehyde free surface dis infectants which have been ap proved and released by the RKI and the VAH can be used in accordance with the instructions on the label The cleaning of the parts could be done manually in immersion or ul trasonic bath for 10 30 minutes preferable at temperatures of up to 50 C Procedure 1 Rinse excess soil from compo nents 2 Using soft brush apply detergent solution to all surfaces ensuring that hinged components are cleaned in both open and closed positions 3 The part is held under running water for 5 minutes In this case the running water must flow through the cannulas The blind holes must be repeatedly filled and emptied 4 The parts must be cleaned as long as no visible blood or tissue residues more on the products to be seen For manual disinfection it is advisa ble to insert the parts for expected parts see left column in the solution immediately after use Ensure that the parts are completely submerged in the solution Take the parts from the solution after the described time NORAS mr Breast Biopsy 4
41. gulat ed biopsies please note that the center of rotation varies from the standard NORAS positioning devices The center is located 68 mm not the usual 22 mm behind the head of the pointer which is visible in the MR image In order to calculate the coordi nates you have to subtract 68 mm from the position of the head of the pointers line For angulation 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 possi ble for 15 and 30 After the angulations adjustment close the adjustment screw slowly until the new position of the fiducial holder is fixated Height angle adjustment screw oo MR Targeting Set Ethicon Guide fork Ethicon Clamping screw Targeting Set Ethicon MRI Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 57 Localization and Biopsy Process In case of a very anterior lesion position the guide fork Ethicon can be set on a higher position which enables another 17 mm anterior access Please note that in this procedure the holster must be held upside down so that tissue samples will fall downwards Vertical and horizontal Lowest adjustable 0 position of the pointer position of the pointer After adjustment of the calculated coordinates please perform a control scan with installed Ethicon guide fork The scan shows the pointer as a light line which points towards the lesio
42. hosen in step 5 is located in our example on slice position 27 1 superior the marker in slice position 12 9 inferior In order to reach the le sion you have to move the Post amp Pillar positioning unit 27 1 2 9mm 30mm 9 Move the Post amp Pillar positioning unit with the marker according to the calculated coordinates UT tense u Wanny 4 CANET l ori SNI oan aa yny ka A LTT NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 47 Localization and Biopsy Process 10 Perform a control scan in order to check that the marker is located in front of the lesion 11 Use the distance tool again in order to measure the puncture depth from the surface of the skin to the middle of the lesion in this case 19 8 mm Subtract an offset depending on the biopsy system normally about 5 10 mm in order to posi tion the cannula lie in front of the lesion Now puncture the breast with the trocar using this offset corrected depth starting at skin surface Afterwards pull the needle out of the trocar and insert the plastic bar into the cannula instead The plastic bar causes less artifact than the needle and prevents blood back flow into the cannula Optima MRASOm 1 57 Praxis Buesselberg Glerke Ex 7639 Se 4 1O4t Ax S2f 14t De VWIBRANT 10 ea 11 1 50kHz H 4Breast Noras FL p i 368 36 Localization and Biopsy Process 12 Perform a control scan in order t
43. ibe where you can find our various rating plates on your product In addition to the above described symbols you will also find the mod el product and serial number on these plates NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T produc ts 13 Device Description 4 1 1 Rating Plates Base Plate The rating plate is located on the underside Grid Biopsy Unit lateral medial cranio caudal The rating plate is located on the upper right Post amp Pillar Positioning Unit The rating plate is located on the telescopic square outside Patient Rest The rating plate is located on the underside Patient Pad Coil The rating plate is located on the housing cover Positioning Device Big Punch The rating plate is laser engraved on the guide bar lengthwise Needle Carriage Ethicon The rating plate is laser engraved on the needle car riage Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 14 Device Description 4 2 System Components 4 2 1 Patient Rest with Breast Cushion and Head Rest The upper part of the Patient rest is made of Polyphenylene Sulfide Resins PPS The bottom part is machined out of PC GF Lexan 505RU The surface has been fin ished with two component coating The breast cushion and the head rest are made of PE Patient Rest Breast Cushion Head Rest Ref 117720 Ref 114971 Ref 117758 4 2 1 1 Coils 4 2 1 2 Bottom Array Coil FBC Frame Breast Coil
44. ice with similar functions as the standard version In order to sup port 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 lateral guide bar A cranio caudal guide bar Sdi 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 height and angle adjustment screw S r a scaled Guide Rail Guide Plate D a O Guide Bar Fiducia Holder Needle Guide Girder Pointer Guide Fork Ethicon Right Immobilization Plate The vertical 0 position is indicated by the upper edge of the fiducial holder and the 0 base at the guide bar For height adjustment anterior posterior please adjust the fiducial holder at the requested position and close the adjustment screw NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 56 Localization and Biopsy Process The modified positioning device is now installed and 0 based In order to extract markers and coordinates please follow chapter instructions For horizontal biopsies no angulations 0 the handling of the NORAS Mammo tome MR Adapter is equal to the standard NORAS positioning devices For an
45. il BI 320 PA GE 1 5T Disinfectant Depending on RDG and Vario TD program you can select on disinfectant which has been approved and released for automated disinfection Procedure lf automated disinfection is em ployed a final rinse at 90 C for 5 minutes may be used to effect thermal disinfection The parts such as needle guides and needle blocks can be disinfected in accordance with the same procedure in an ultra sonic bath The assembly must be disassem bled into its individual components so that an optimal disinfection is guaranteed MRI products Applicable only for Biopsy Set consists of Base Plate Fixation Plate lateral medial Slate Plate vertical amp horizontal Curved Slate Plate vertical amp horizontal Post amp Pil lar Positioning Unit Post amp Pillar Marker Needle Guide Sleeve Set Grid Localization Needle Block Set Grid Markerblock Blocking Plate Autoclave Box Needle Guide Post und Pillar Adapter for Ethi con SenoRx ATEC Vacora Grid Needle Block Adapter for Ethicon SenoRx ATEC Vacora Cleaning Disinfection and Sterilization Cleaning and Disin fection manual The following parts may not be inserted in immersion baths and be held under running water all coil types all coil cables and plugs bottom array coils FBC patient pad coils PPC The above men tioned products can be wiped cleaned with a flu
46. iquid before auto claving and refill afterwards NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 95 Technical Specification pemon m Post amp Pillar Needle Guide Sleeve Set for 18G 16G and 13G autoclavable and reusable Material PEEK also individually acquirable Post amp Pillar Needle Guide Sleeves for 18G 16G 14G and 12G disposable in sterile packag ing packaging consists of 5 pieces Base Unit Fixation Plate can be used laterally medially and cranio caudally and is used as adapter for the slat plates of the grid reusable disposable and for attaching the positioning system Slat Plate Vertical medial cranio caudal Slat Plate Vertical lateral only for NORAS BI320 Slat Plate Horizontal medial cranio caudal Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T WW 7 18G 112654 16G 112597 14G 112655 12G 112653 111242 Koig o dh E LE 7 MRI 96 products Technical Specification pemon Win Slat Plate Horizontal High me 118144 dial cranio caudal for thorax prox imity interventions Slat Plate Horizontal lateral only 111301 for NORAS BI320 9 4 3 Accessories for Grid Biopsy System pemon ini Grid Markerblock autoclavable 111251 and reusable material PEEK remove marker liquid before auto claving and refill afterwards Grid Needle Block Set for 18G 111299 14G and 12G used for biopsie
47. must not be cleaned in immersion baths or held under running water Non respect of the cleaning instructions may cause the destruc tion of the coils NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T produc ts 81 Cleaning Disinfection and Sterilization Danger of destruction The coils must not be disinfected in immersion baths or held un der running water Non respect of the disinfection instructions may cause the de struction of the coils When drying is achieved as part of washer disinfector cycle do not exceed 50 C Maintenance Inspec Blunt or damaged parts should be discarded Hinged tion and Function Test parts Check for smooth movement of hinge without ex ing cessive play Locking ratchet mechanism should be checked for action All parts Visually inspect for damage and wear Cutting edges should be free of nicks and present a continuous edge Check components with long slender features particularly rotating components for distortion Where components form part of a larger assembly check assembly with associated components Packaging Singly A standard packaging material may be used Ensure that the pack is large enough to contain the in strument without stressing the seals In sets The parts may be loaded into dedicated instru ment trays or general purpose sterilization trays Ensure that cutting edges are protected and do not exceed the maximum loading per tray Wra
48. n The distance between skin and lesion along this line indicates the insertion depth of the needle inside the breast Following the position and control scans see 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 and instruction information about the specific Targeting Set please look at the manual of your vacuum system manufacturer Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 58 Localization and Biopsy Process Bodily injuries due to accessories The NORAS Mammotome MR Adapter may only be used if the operator s manual of the vacuum system manufacturer was read and understood The NORAS Mammotome MR Adapter is compatible with the Ethicon Holder for the reception of the Ethicon Mammotome MR Universal Targeting Sets MRU11S MRU11X MRUO8S and MRUO8X Danger of injury and delocalization The NORAS Mammotome MR Adapter is the guidance and po sitioning of the Targeting Set as well as the vacuum system In addition it can carry the Targeting Set individually into the con trol scan The NORAS Mammotome MR Adapter is not capable of carrying the weight of the vacuum system individually During the control scan the Mammotome Targeting Set must not slip NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 59 Localization and Biopsy Process 6 1 2 Post amp Pillar Adapter for
49. nd Disinfecting section of the manual understand the indications for use and the functionality of the Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T and am aware of the components of the Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T the installation of the Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T the complete setup of the Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T the connection to the MRI the application on patients the localization and biopsy process the MR Mammography the cleaning instructions the disinfection instructions the sterilization instructions that it is NOT NORAS responsibility for timely replacement of worn out parts NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T produc ts 102 Operator Training Outline Title Name Department Date amp Signature LContac Person E Mail Address Phone No Customer Trained by NORAS Application Trainer Date amp Signature NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T produc ts 103 Your Notes NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T produc ts 104 Your Notes NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T produc ts 105
50. ng the trocar Having removed the trocar close the cannula using the provided equipment sterile plastic stick This prevents blood from entering the cannula e 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 pene trate with the needle to the lesion Perform the biopsy in accordance with the instructions of your needle and or vacuum manufacturer Control scan shows large or no image distortion Please pay attention to removing the metal trocar when inserting the cannula When using a plastic cannula the metal trocar has to be replaced by the provided plastic stick Needle penetration at incorrect location Please take care of using a needle with the appropriate size gauge as well as the corresponding needle guide sleeve In case of extreme small needle sizes the lesion may be missed In case of extreme large needle sizes there is a risk of damage to the needle Insufficient penetration depth Please take care of using a needle with the appropriate length Using a too short needle you might not reach the lesion NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 69 Localization and Biopsy Process After completion of the biopsy clean the device parts as described in chapter 7 Cleaning Disinfection and Sterilization Danger of penetration through the breast Should under excepti
51. o check that the end of the needle is positioned in front of the lesion The further biopsy may then be carried out by authorized personnel Control scan shows large or no image distortion Please pay attention to removing the metal trocar when inserting the cannula When using a plastic cannula the metal trocar has to be replaced by the provided plastic stick Needle penetration at incorrect location Please take care of using a needle with the appropriate size gauge as well as the corresponding needle guide sleeve In case of extreme small needle sizes the lesion may be missed In case of extreme large needle sizes there is a risk of damage to the needle Insufficient penetration depth Please take care of using a needle with the appropriate length Using a too short needle you might not reach the lesion Perform the biopsy in accordance with the instructions of your needle and or vacuum manufacturer After completion of the biopsy clean the device parts as described in chapter 7 Cleaning Disinfection and Sterilization NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 49 Localization and Biopsy Process Danger of penetration through the breast Should under exceptional circumstances the needle be bent while in the breast e g if the needle should strike one of the three horizontal slats after penetrating through the breast clip off the distally deformed needle end with a s
52. onal circumstances the needle be bent while in the breast e g if the needle should strike one of the three horizontal slats after penetrating through the breast clip off the distally deformed needle end with a suitable MR compatible tool and remove the remaining trocar Retraction of the needle with the bent end section would injure the breast Danger of bruising Be absolutely sure to loosen the slat lateral plates before with drawing the breast That way bruises or injuries to the patient can be avoided Danger of injury Before loosening and withdrawing the breast you must remove all instruments If all instruments are not removed you may injure the breast of the patient NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 70 Localization and Biopsy Process 6 2 1 Grid Needle Block Adapter for Ethicon Mammotome MR Lo For use with the Ethicon Mammotome MR the NORAS company offers reusable needle block adapters made of PEEK These ensure the compatibility of the Mammo tome MR Universal Targeting Sets MRU11S MRU11X MRUO8S and MRUO8xX with the NORAS grids The positioning process is described in chapter 6 2 After the suc cessful positioning process of the needle block adapter 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 Adapter for SenoRx EnCor _ For use with the SenoRx EnCor M
53. onstant temperature 23 C 2 C Constant humidity below 60 rel humidity Additional In When sterilizing multiple instruments in one autoclave cycle formation ensure that the sterilizers maximum load is not exceeded Manufacturer See chapter 10 Contact Danger of destruction Improper disinfection may result in malfunction of the device Non respect of the disinfection instructions may cause the de struction of the device No warranty service will be provided for damages due to improper disinfection Danger of infection G28 The disinfection instructions must be followed In case of inadequate disinfection the risks of infection arise to eae user and or end user NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 84 Cleaning Disinfection and Sterilization Danger of destruction Improper sterilization may result in malfunction of the device Non respect of the sterilization instructions may cause the de struction of the device No warranty service will be provided for damages due to improper sterilization Danger of infection The sterilization instructions must be followed In case of inadequate sterilization the risks of infection arise to 611 035 user and or end user NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 85 Maintenance Storage and Waste Disposal 8 Maintenance Storage and Waste Disposal 8 1 Maintenance P
54. opsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 9 Function 3 Function The 4 Channel Breast Coil System described in this document has been designed for use with a MRI system with field strength of 1 5T The coil system consists of pure receiving coils for the reception of high frequency signals from the hydrogen H nuclei The hydrogen nuclei are induced into preces sion 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 Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T 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 manufac tured by the NORAS company Interconnection is handled by the software of the MRI The 4 Channel mammographic coil offers flexible use to meet the needs of the pro cedure to be performed in your clinic The upper 2 channel Pad Coil can be sup plied as a 1 5T model It is removable and enables the biopsy device to be used with the respective corresponding coil with the different field strengths The both channels in the lower area are firmly integrated in the patient rest and can be combined for imaging with the upper 2 channel patient pad coil That way the two devices form a high resolution 4 channel phased array configuration
55. or use of the respective disinfectant solution NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 76 Cleaning Disinfection and Sterilization INSTRUCTIONS Point of Use Remove excess soil with disposable cloth paper wipe Storage and No particular requirements It is recommended to perform the Transport processing of the product as soon as possible after its use The products must be transported in a closed container Preparation for No particular requirements If necessary the assembly must Cleaning be disassembled into its individual components Needle blocks and needle guide sleeves could possibly be pre cleaned by syringe or water nozzle Cannulas and holes must be connected in accordance to rinse body Pay attention to correct flow Preparation with H202 or enzymatic cleaner could be done NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r odu C ts T7 Cleaning Disinfection and Sterilization Cleanin auto mated All parts can be cleaned by ma chine the excep tion cases are coil cables and plugs patient rests patient pad coils PPC bottom array coil FBC breast cushion head rest vacuum mattress es Equipment Washer disinfector Detergent Example alkaline deter gent such as Neodisher MediCle an forte 0 2 1 0 vol 2 10 ml l Dr Weigert at 50 C For this pur pose all agents which have been approv
56. ossible parallel to the magnet opening and not perpendicular to it NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 28 Start Up 5 2 Plug in and unplugging coils Plug in both coil plugs into the connections provided on the MRI table on or off Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r odu C ts 29 Start Up After plug in the coil a green LED lights up The coil is identified and ready for meas ure Prolongation or termination of the treatment While plugging in the coil pair ensure and check proper contact has been made Check the display of the MRI If the coil pair is not properly plugged in no images can be pro duced The Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T is recognized by the MRI software The software operation is described in the GE MRI operator s manual NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r odu C ts 30 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 Risk of destruction Pay attention and comply with the cleaning and disinfection in structions contained in this operator s manual see chapter 7 Cleaning Disinfection and Sterilization Coils must not be held under wa
57. p the trays using appro priate method See also guidance of DGSV RKI and DIN EN ISO 11607 1 NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r odu C ts 82 Cleaning Disinfection and Sterilization Sterilization Steam sterilization The following Only the following items may be subjected to steam steriliza parts may be tion Sterilized neither on basis of STERRAD not Ease Plate Fixation Plate lateral medial Slate Plate vertical steam _ steriliza amp horizontal Curved Slate Plate vertical amp horizontal Post amp tion Pillar Positioning Unit Post amp Pillar Marker Needle Guide Sleeve Set Grid Localization Needle Block Set Grid Marker block Blocking Plate Autoclave Box Needle Guide Post und plugs Pillar Adapter for Ethicon SenoRx ATEC Vacora Grid patient rests Needle Block Adapter for Ethicon SenoRx ATEC Vacora Biopsy Set consists of coil cables and patient pad coils PPC Procedure bottom array coll 134 C 3 04 bar 5 min FBC The effectiveness of steam sterilization according to the proce breast cushion dure mentioned above has been validated by Dr Schwarzkopf head rest Markers must be emptied prior to sterilization NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r odu C ts 83 Cleaning Disinfection and Sterilization Storage Safe dry dust free and protected from light C
58. rior to each use all components of the Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T must be visually inspected and controlled for breakage cracks and wear off Patient Rest Patient Pad Coil cable and plug Check for breaks or cracks Frame Breast Coil cable and plug Immobilization and Fixation Unit Defective products must not be used In such a case please contact NORAS MRI products GmbH Comply with the cleaning disinfection and sterilization instructions We recommended that you have a single channel test of the coils performed on a monthly basis using the specified test program of the MRI system NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r odu C ts 86 Maintenance Storage and Waste Disposal Functional tests In case coil malfunctions are suspected the operator may perform the functional test described below After positioning an axial slice through two phantom bottles the four channels of the coil should be shown similar to the following illustrations Display of channel 1 no name 50379 Sep 25 2015 Mag 1 0 5 0thk 0 0ap C NORAS mr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r odu C ts 87 Maintenance Storage and Waste Disposal Display of channel 2 no name 50379 Mag 1 0 5 0thk 0 0ap c Display of channel 3 no name 50379 Mag 1 0 5 0thk 0 0ap c Maintenance Storage and Waste Disposal Display of channel 4
59. s Compatible with all NORAS 4 Channel Breast Coils and NORAS Patient Rests BI320 PA Usable for immobilization and MR guided biopsy Our biopsy system consists of superior plastics PEEK and can be used for all tradi tional sterilization processes autoclavable One has the option to purchase dispos able grids for medial lateral and cranio caudal use for the height adjustable grid units The functional unit can be build cost effectively and can be extended based upon request NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 21 Device Description Application Examples Modular set up To fixate the breast several of height adjustable horizontal and vertical slat plates can be used as well as a medical disposable grid or the reusable grid To perform biopsies one can choose from the Post amp Pillar or Grid Method Post amp Pillar Biopsy System lateral with one lateral horizontal slat plate and one medial horizontal slat plate to fixate the breast Post amp Pillar Biopsy System medial or cranio caudal with two medial horizontal slat plates to fixate the breast Grid Biopsy System lateral with height adjustable lateral grid and medial horizontal slat plate to fixate the breast Grid Biopsy System lateral medial or cranio caudal with grid and medial horizontal slat plate to fixate the breast Grid Biopsy System lateral with disposable lateral grid and medial horizontal slat plate to fix
60. s and wire markers autoclavable and reusable material PEEK Grid Biopsy Unit lateral medial 111252 CC autoclavable and reusable material PEEK Grid Biopsy Unit Height Adjust 117143 able lateral autoclavable and re usable material PEEK NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 97 Technical Specification Description Grid Biopsy Unit Height Adjust 112235 able lateral disposable in sterile Sir ry packaging packaging consists of 5 grids Grid Biopsy Unit Height Adjust 112238 able medial CC disposable in sterile packaging packaging con sists of 5 grids Grid Needle Blocks for 18G 18G 112660 16G 14G and 12G disposable in 16G 112143 sterile packaging packaging con sists of 5 pieces 14G 112659 12G 112731 NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 98 Technical Specification 9 4 4 NORAS Adapter for Vacuum Guns For our biopsy units we offer a large amount of adapters for the traditional vacuum guns Upon request we can also manufacture suitable adapters for your system Your Vacuum System Adapter for Grid System Adapter for Post amp Pil lar System a MR10061 VAC MR10062 VAC J He Xe MR10061 AT MR10062 AT R R SenoRx EnCor 10G MR10061 SE 10G MR10062 SE 7G on request 7G 113315 Ethicon Mammotome MR10061 ET MR10062 ET2 NORAS mrr Breast Biopsy 4 Channel Coil BI 32
61. st to be biopsied by pressing the fixation plates on the raster bars against the breast Be careful to ensure that the patient can lie as comfortable as possible during the entire procedure You now have medial access below the blocking plate or lateral access from the outside NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 63 Localization and Biopsy Process Cranial caudal access Slide the fixation plate with the medial slat plate re usable or with a second dispos able medial grid onto the shorter raster bars of the base plate Ref 111292 as far as it goes Slide the second fixation plate with a disposable medial grid onto the longer raster bars of the base plate marked Lateral CC up to the stop Proceed as de scribed above access medial and lateral Please note that when the biopsy device is turned into the cranio caudal direction the MRI images must be made in the axial or transversal direction to correspond with the following description During the examination some parts of the breast may come into contact with the surface of the base plate with the low probability Before each examination of the patients the base plate must be covered with a clinical cloth Needle penetration at incorrect location The breast must be correctly immobilized If the breast is not immobilized properly it might slip and the data delivered by the MRI might be inaccurate e Ensure that as much
62. t and fixate the breast to be biopsied by pressing the slat plates on the raster bars against the breast Be careful to ensure that the patient can lie as comfortable as possible during the entire procedure Now you have medial access below the blocking plate or lateral access from the outside NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 39 Localization and Biopsy Process Zugang cranial caudal To enable cranial caudal access proceed as described previous to provide medi al lateral access Please note that when the biopsy device is turned into the cranio caudal direction the MRI images must be made in the sagittal direction to correspond with the follow ing description During the examination some parts of the breast may come into contact with the surface of the base plate with the low probability Before each examination of the patients the base plate must be covered with a clinical cloth Needle penetration at incorrect location The breast must be correctly immobilized If the breast is not immobilized properly it might slip and the data delivered by the MRI might be inaccurate Ensure that as much breast tissue as possible is held between the slat plates 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 Post amp Pillar positioning unit in horizontal
63. ter Non compliance with the instructions in chapter instructions con tained in this operator s manual see chapter 7 Cleaning Disin fection and Sterilization of this operator s manual may destroy the coils NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 31 Start Up 5 3 Positioning of the Patient Rest 5 3 1 Feet First Position the system on the MRI table and plug in the coil plug as shown in the illus tration 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 NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 32 Start Up Patient positioning Place the patient in prone position with the breasts in the open area Patient positioning with arms over the head 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 To avoid this please place an adequate cushion between the hands Use adequate positioning cushions Position the coil at the magnet by means of the laser sight on the Patient Pad Coil The laser sight has to be aligned with the center of the coil NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T pr odu C ts 33 Start Up 5 4 Marker Filling Instructions The product is delivere
64. 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 injury of the patient Prior to each patient examination you should make a careful visual inspection of the system components In case of unusual findings and or damage found the system must not be used Damaged parts can be sharped edged and Cause injuries to the patient and or to the user Do not use dam aged coils Do not produce images with a defective coil Assemble the desired configuration of the biopsy device While pushing it onto the fixation 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 biopsy device into the insertion opening provided Ensure that the device is firmly seated NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 27 Start Up 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 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 cable trap must be aligned as closely as p
65. uitable MR compatible tool and remove the remaining trocar Retraction of the needle with the bent end section would injure the breast Danger of bruising Be absolutely sure to loosen the slat lateral plates before with drawing the breast That way bruises or injuries to the patient can be avoided Danger of injury Before loosening and withdrawing the breast you must remove all instruments If all instruments are not removed you may injure the breast of the patient NORAS mrr Breast Biopsy 4 Channel Coil BI 320 PA GE 1 5T p r O du C ts 50 Localization and Biopsy Process b Angulated manual calculation of coordinates for the MR supported breast biopsy with the NORAS Post amp Pillar Biopsy Unit on GE MR systems Perform the steps 1 to 10 from the user manual for the straight manual calculation of coordinates If you notice during the straight biopsy that for example one of the bars of the grid is in the way of the biopsy or if you prefer to continue with an angu lated biopsy for any other reason you can also work with an angulation of 15 or 30 degrees toward the top or the bottom 13 Now an angle of 15 degrees in this example has to be drawn to the original marker line To do so one needs to use the angle tool 14 Draw the first line in this example from right to left through the marker toward the lesion Optima MR4A5Cm 1 5T Praxis Buesselberg Gierke Ex 7039 10 Ax S27 140 10

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