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Manual BI 320-PA-NO - Noras MRI products

1. 2u220022000000n0n 104 8 Maintenance storageandwastedisposal 113 8 1 Maintenance 02202202s0snunnnnnnnnnnnnnnnnnnnnnnnennennennennennennn nenne nnnnnnnnnnn 113 92 ON AGS een 122 O WV ASIC OS m ear ar Na A an yl lm la 122 9 Technical Specification 2 22 2002000n00n000n0nnun nun nun nun nun nun 123 9 1 FNSTON Cal DEVICE Dala ee een 123 OZ BEroimance BE 124 93 EA A 125 9 4 Options and ACCCSSOMCS EM SN NE E EE EE e 126 9 4 1 CompilationoftheBiopsyUnit 126 9 4 2 AccessoriesforPost amp pPilarBiopsySystem 126 9 4 3 AccessoriesforGridBiopsySystem 128 9 4 4 NORASAdapterVacuumguns 130 e lt p A A YY 131 10 Important Adresses ami Monad aa damn alam ede eee 132 11 Operator IrainingOutline 000 een 133 VM HOLES 2 ana e be e e pa a a pe yea a pe po m 135 NORAS mre products 4 BI320 PA NO 1 5T 3T General Information 1 General Information A prerequisite for safe and trouble free operation is the proper observance of instructions in particular the following points The coil system patient pad coil and insertion plate coil of the Breast Biopsy 4 Ch Coil BI 320 PA NO 1 5T 3T can be used with the following MRI systems 1 5T Siemens 1 5
2. BI320 PA NO 1 5T 3T Device Description The sterile disposable grid is for single use only it is not resteri lizable and must be properly dispose 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 NORAS mrr products BI 320 PA NO 1 5T 3T 21 22 Device Description b Modular NORAS Biopsy Units Compatible with all NORAS 4 Ch breast coils and NORAS patient rest 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 Applications 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
3. nyons ajJun 01 08 2007 16 37 45 Siemens Sequence Region Siemens Sequences Default Protocols gre The make the following final sequence adjustments Field of view 360 mm Coil selection all four channels of the breast coil Menu System Subitem Coils NORAS mrr products BI320 PA NO 1 5T 3T Maintenance storage and waste disposa Noras Brustspule 2007 Noras Brustspule 2007 1 IMA 1 5 01 08 2007 nyons 9jun 10cm M DISZD Localizer Start Sag Field of View 07 01 01 1980 TA 0 14 PM REF PAT Aus Voxelgr e 2 8 Abbrechen Schichtgruppe 1 Schichten 1 9 Distanzfaktor Schichtdicke Position L0 0 P0 0 H39 Fl T Orientierung Transversal T Phasenkod Richt A gt gt P WE Mittelungen Phasen Oversampling 9 1 oe e Verkn pfungen Filter Spulenelemente 2 0 en auf Schichtpositionierung products BI 320 PA NO 1 5T 3T 117 Maintenance storage and waste disposal Noras Brustspule 2007 Noras Brustspule 2007 11MA 1 6 01 08 2007 nyons 9jun M DISZD Localizer Start TA 0 14 EM REF PAT Aus Voxelgr e 2 8x2 8x5 0 mm Rel SNR 1 44 fl Sender Empfanger gee alee Uberspringey Warten auf Schichtpositionierung S NM Select four channels NORAS mrr products 118 BI320 PA NO 1 5T 3T Maintenance storage and waste disposal Store individual channel data separately Noras Brus
4. 106 Cleaning auto mated All parts can be cleaned by ma chine the excep tion cases are alltypes of coils all coil cables and plugs all patient rests all patient pad coils all insertion plate coils all cushions all head cushions all vacuum mat tresses Equipment Washer disinfector Detergent Example alkaline detergent such as Neodish er MediClean forte 0 2 1 0 vol 2 10 ml l Dr Weigert at 50 C For this purpose all agents which have been ap proved 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 hinges are open and cannulas and holes can drain For needle blocks and needle guides a pre cleaning by means of sy ringe or water jet may be nec esSary 2 Run cycle minimum 5 minutes clean and 5 minutes rinse 3 When unloading check can nulas holes etc for complete removal of visible soil If neces sary repeat cycle or use man ual cleaning NORAS mre Cleaning Disinfection and Sterilization Applicable only for Biopsy Set consists of Base Plate Fixation Unit lateral medial Slat Plate vertical amp horizontal Curved Slat Plate vertical amp hori zontal Positioning Unit Post amp Pillar Marker Needle Guide Sleeve Set Grid Localization Cube Set Blocking Plate Autoclave Box Guide Sleeves Post und Pillar
5. 8 1 Maintenance Prior to each use all components of the Breast Biopsy 4 Ch Coil BI 320 PA NO 1 5T 3T must be visually inspected and controlled for breakage cracks and wear off Patient Rest Check for breaks or cracks Patient Pad Coil cable and plug Check for breaks or cracks Insertion Plate 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 The data regarding the test performance and its results must be recorded in the medical devices log book NORAS mre products BI 320 PA NO 1 5T 3T 113 Maintenance storage and waste disposal Functional tests In case coil malfunctions are suspected the operator may perform the function al test described below Insert the standard Siemens 2I phantom bottle into the coil as shown on the il lustration and connect the coil to the MRI scanner Coil with two 21 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 that the bottles are positioned in the center of the loops of the patient rest pad Phantom bottle positioned in center of loop at he
6. Manual Biopsy A MRB Forschungszentrum fuer Magnet Resonanz 01 01 1980 31Y MRI products BI 320 PA NO 1 5T 3T 53 Localization and Biopsy Process 9 Move the Post amp Pillar positioning unit with the marker according to the calcu lated coordinates in our example 22 mm downwards anterior and 18 mm to wards the head HOTTA oz nk Eyy muy 7 NORAS mrr products 54 BI320 PA NO 1 5T 3T Localization and Biopsy Process 10 Perform a control scan in order to check that the marker is located in front of the lesion A MRB Forschungszentrum fuer Magnet Resonanz MRI products BI 320 PA NO 1 5T 3T 55 Localization and Biopsy Process 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 68 mm Sub tract an offset depending on the biopsy system normally about 5 10 mm in order to position the cannula lie in front of the lesion Now puncture the breast with the trocar using this offset corrected depth start ing 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 Manual Biopsy A MRB Forschungszentrum fuer Magnet Resonanz Es 01 01 1980 O 31Y MR 11 ane f A Manual Biopsy 24 30 v IMA 26 35 ister EHEM
7. holi iy MF 1 00 TE 130 02 09 SP H25 0 MRI products 56 BI320 PA NO 1 5T 3T Localization and Biopsy Process 12 Perform a control scan in order to check that the end of the needle is posi tioned in front of the lesion A MRB Forschungszentrum fuer Magnet Resonanz The further biopsy may then be carried out by authorized personnel NORAS mrr products BI 320 PA NO 1 5T 3T 57 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 set 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 products 58 BI320 PA NO 1 5T 3T Loca
8. plate coil in the lower area can be combined for imaging with the upper 2 channel patient pad coil 1 5T or 3 0T 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 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 mrr products BI 320 PA NO 1 5T 3T 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 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 the compression plates and needle blocks Biopsy access is single sided medial single sided double sided lateral or single sided double sided cranio caudal The raster pin is placed in the ring on the lower side of the base plate It provides exact alignment of the base plate in medial lateral or cranio caudal direction The alignment becomes necessary when using a navigation software which is available optionally through Siemens The ability to adjust the Biopsy Unit by 270 is only possible when calculat
9. 3T Intended Use Indication for use 2 Intended Use Indication for Use The intended use of the NORAS Breast Biopsy 4 Ch Coil BI 320 PA NO 1 5T 3T is in conjunction with a Magnetic Resonance Scanner the MR exami nation of the female breast It is indicated for use as a diagnostic imaging de vice to produce transverse sagittal coronal ad 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 permits MR guided breast biopsy and wire lo calization of lesions can be performed by a trained physician NORAS mrr products BI 320 PA NO 1 5T 3T Intended Use Indication for Use 2 1 Indications Tumor recognition in the case of unclear diagnoses from other diagnostic pro cedures using contrast agents and their decay times Breast biopsy i e biopsy from lateral cranio caudal and medial direction 2 2 Contraindication All patient examinations are contraindicated with this system which is also con traindicated in the proximity of the MRI device according to the information pro vided by the manufacturer e g breast implants heart pacemakers surgical metallic implants or similar objects Furthermore the responsibility lies with the examination physician in case of unclear or critical clinical picture Please follow the safety instructions of MRI m
10. 3T 91 Localization and Biopsy Process Cranial caudal access Slide the fixation plate with the medial slat plate re usable or with a second disposable 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 me dial grid onto the longer raster bars of the base plate marked Lateral CC up to the stop Proceed as described above access medial and lateral Please note that when the biopsy device is turned into the cranio caudal direc tion the MRI images must be made in the axial or transversal direction to corre spond with the following description 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 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 lateral plate and the grid fixation plate Insert the marker block supplied into the grid fixation plate NORAS mrr products 92 BI320 PA NO 1 5T 3T Localization and Biopsy Process Medial Lateral Anterior e Detect the marker block and the lesion in the MRI using sagittal slices Mark the lesion with a permanent auxiliary l
11. Biopsy System medial or cranio caudal with two medial horizontal slat plates to fixate the breast Grid Biopsy System lateral with height adjustable lat eral grid and medial horizontal slat plate to fixate the breast NORAS mrr products BI320 PA NO 1 5T 3T Device Description 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 fixate the breast NORAS mrr products BI 320 PA NO 1 5T 3T 23 Device Description 4 2 4 Accessory Cranio Caudal Fixation CC 320 Plus Ref 118341 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 fixation consists of one base plate two pressure plates left and right with cushion breast which enables through the guidance bar and the affixed handle bars the fixation The proper adjustment is achieved by two locking screws Guidance bar Pressure plate left Pressure plate right 4 i Locking screw Breast Cushion Handle bar for CC Base Plate NORAS mrr products 24 BI320 PA NO 1 5T 3T Device Description 4 2 5 Combination with other devices The coil system patient pad coil and insertion plate coil of the Breast Biopsy 4 C
12. NO 1 5T 3T Operating errors may cause bodily injuries e g contu sions to the user and or patient NORAS mrr products BI 320 PA NO 1 5T 3T 2 Start Up Danger of infection Prior to start up of the devices or parts thereof all com ponents must be treated as described in chapter Clean ing 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 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 damaged coils Do not produce images with a defective coil NORAS mrr products 28 BI320 PA NO 1 5T 3T Start Up Push the insertion plate coil into the patient rest until it snaps into place Ensure that the insertion plate coil has been completely push
13. Pillar Adapter for Ethicon SenoRx ATEC Va cora Grid Needle Guide Adapter for Ethi con SenoRx Atec Vacora Cleaning Disinfection and Sterilization Cleaning and Des Equipment Applicable only for infection manual Detergent Example Biopsy Set consists of The following parts Sekusept PLUS Ecolab boca Pal Eyalen may not be inserted 4 0 vol Korsolex Plus isterslimedisi in immersion baths 3 0 vol with exposure Slat Plate vertical 2 and be held under time of 15 minutes For this running water purpose all aldehyde free Plate vertical amp horizon alae Ike gt tal Positioning Unit ave been approved and re Post amp Pillar Marker all coil cables and jeased by the RKI and the Nase Gude Sleeve plugs VAH can be used in accord sa Grid Localization insertion plate coils ance with the instructions on Cube Set Blocking the label horizontal Curved Slat all coil types Plate Autoclave Box The cleaning of the parts Guide Sleeves Post could be done manually in und Pillar Adapter for immersion or ultrasonic bath Ethicon SenoRx for 10 30 minutes preferable ATEC Vacora Grid at temperatures of up to 50 C Needle Guide Adapter for Ethicon SenoRx ATEC Vacora patient pad coils The above men tioned products can be wiped cleaned with a fluff free mois tened cloth Due to possible ma terial incompatibility Procedur
14. Post amp Pillar marker with an angulation of 15 or 30 degrees toward anterior or posterior at the beginning The following example shows the angulation of the marker of 15 degrees to ward anterior 1 Perform a measurement with transversal slices and look for the slice where you can see the marker est Biopsiel 23456 Avanto a a 0 103 MR B19 STUDY 4 HFP 7062015 ER 2 36 20 VB Chiru el 03 lk 33 1104 Sc YE 1 00 DE TPO SP F24 4 SL1 6i ANOR MIDIS nel B a ee En 1 JPFP en BL 14ml Dotarem Jo 77 gt ladi 125 EE A AL j BI320 PA NO 1 5T 3T Localization and Biopsy Process 2 Start the distance tool menu right center Extras distance ruler and draw a line angulated like the adjusted marker through the image and the marker Mark that line with a left click and select the marked line with a right click In the context menu select copy or Strg C By doing so the line is copied and can be pasted into other slices Test Biopsiet 23456 11414911 0 103 Ayvanto MR B19 HFP TU 1 LPH MEZ VE Chirurgiz 1 1 Distance 10 73 cm 1 Mira D 71134 MF 1 00 DE TP 0 SPF24 4 MMORM DIS2D roy EL 15i AUPFP C 2AL 14ml Dotarem 31 125 A A R urn Ar u I TR SE di AEA a A a ie b a A gt xa m AFAN i et j b f oy ii g gt iol g 1 i Airs hy q Mare fom ay u Pp zt Va is oe Bu TAT ww ew lt a wi manen ii
15. coil to mri noras de or go to www noras de The application conditions have a major impact on product life Since these conditions 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 Process Method 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 Mechanical wear is dependent on the frequency of application and for the above mentioned reasons it cannot be assessed quantitatively 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 manufac turer for operators patients and third parties Prescription use only Country specific laws restrict this device to sale by or on the order of a physician or with the descriptive designation of any other 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 ue licensed practitioners or to persons who have a prescrip tion or other order from a licensed practitioner to purchase it NORAS mrr products BI320 PA NO 1 5T
16. line MRI products 64 BI320 PA NO 1 5T 3T Localization and Biopsy Process 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 the pivot point of the mechanic is located 7 4 Distanz 2 20 cm Min MaxtrO 695 TP 0 SP H25 0 NORAS mrr products BI 320 PA NO 1 5T 3T 65 Localization and Biopsy Process 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 here 25 4 mm This is the amount you need to move the Post amp Pillar positioning unit posterior toward the ceiling 2 Distanz 2 20 cm 2 Min Max 0 1095 2 1 Winkel 9 Grad 3 Distanz 2 54 cm 3 Min Max 8 1074 NORAS mr products 66 BI320 PA NO 1 5T 3T Localization and Biopsy Process 20 After movement here 25 4 mm posterior and angulation of the marker here 15 degrees toward anterior hence toward the floor perform a control scan in order to check that the marker points at the lesion Now determine simi larly to step 11 the puncture depth from the skin surface to the center of the lesion here 68 6 mm without offset Biziz lim 4 MRI products BI 320 PA NO 1 5T 3T 67 Localization and Biopsy Process 21 After the puncture with the trocar perform another control scan in order to check that the end of the cannul
17. open area aa Patient positioning with arms over the head Please take care that the pa tient does not place his extremi ties 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 cush ions NORAS mrr products 34 BI320 PA NO 1 5T 3T Start Up 5 3 2 Feet first Position the system on the MRI ta ble and plug in the coil plug as shown in the illustration on the left Position the system at the desired location and place the wedge cush ion 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 S8 as shown below Or you can adjust the field of view The shield trap must be aligned as closely as possible parallel to the axis of the magnet bore and not perpendicular to it For more comfortable positioning you can place a foam roll under the patient s legs products BI 320 PA NO 1 5T 3T 35 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 burn
18. 0 PA NO 1 5T 3T Localization and Biopsy Process Note As the position of the table marked with the laser sight seldomly shows the exact zero position one has to pay attention to either subtract or add the coordinates of the slice positions position of marker and lesion Example When the marker of the Post amp Pillar positioning unit is adjusted to zero and the slice position is H24 4 the value H34 8 would have to be subtracted 8 Move the Post amp Pillar positioning unit with the marker according to the calcu lated coordinates in our example 8 7 mm upwards posterior and 59 2 mm towards the head OMAN ow ZA J LITT f i Zer NORAS mrr products BI 320 PA NO 1 5T 3T TE Localization and Biopsy Process 9 Perform a control scan in order to check that the marker points at the lesion Test Biopsiei 3456 Avanta 11111911 0 103 MR 819 STUDY 1 Ai 17062015 ai ya ENER on TEDE VE Chirurgie 1 23 IMA 70 7104 gt SCM WF 1 00 IR 7 8 DE TE 4 o TPO TA LI a 1 cr F H34 By 349 0 zi zL 4 B a L a KL 2D A AE A1FFF EL 14m Dotarem 321 125 i i Gk di i aes a a ms Fans gi m g L NR A di gi j gt y m m ray Me iis j a 5 u i Pd 4 f iy b m 20 Vi DN VD MW m m a ww m e m Wi i AAV a p ZEN IWI pE g MN amp z m Ge S Vvyan g oe B Me my g g mn PE u u JT J Y NroCGLHECETSG KA be E W TUE Gs EG ew Bi ar hae z 78 Y BI320 PA NO 1 5T 3T Local
19. 20 PA NO 1 5T 3T 40 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 personnel Incorrect assembly and operator errors made by untrained personnel 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 de tailed training of the personnel for existing components G22 G43 In the following the localization process with medio lateral alignment of the im mobilization device 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 Sys tem for the examination of a single breast NORAS mrr products BI 320 PA NO 1 5T 3T 41 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 fixa tion plate until the end of the raster bars The fixation unit is now open as far as po
20. 2235 able lateral disposable in sterile Rit packaging packaging consists of 5 grids Grid biopsy unit height adjust 112238 able medial CC disposable in sterile packaging packaging consists of 5 grids Grid needle blocks for 18G 18G 112660 16G 14G and 12G disposable 16G 112143 in sterile packaging packaging consists of 5 pieces 14G 112659 12G 112731 NORAS mrr products BI 320 PA NO 1 5T 3T 129 130 Technical Specification 9 4 4 NORAS Adapter Vacuum guns For our biopsy units we offer a large amount of adapters for the traditional vac uum guns Upon request we can also manufacture suitable adapters for your system Your vacuum system Adapter for Grid Sys Adapter for Post amp Pillar tem System MR10062 VAC Re Kr MR10062 AT MR10061 AT wi Ka Ro 10G MR10061 SE 10G MR10062 SE G on request 7G 113315 Ethicon Mammotome MR10061 ET MR10062 ET2 SP10062 ET for Sie mens Aiming Device NORAS mrr products BI320 PA NO 1 5T 3T Technical Specification Suitable for all NORAS Post amp Pillar units Guidance bracket for Invivo MR10062 MHA disposable needle guidance Disposable needle guidance Multi Hub Assembly not for 113692 7G 9 4 5 General nn Blocking Plate 111319 A blocking plate to raise the al nn ternate breast is required for me dial biopsies Operator s Manual BI320 PA GA BI320 PA 1 NORAS m
21. AA IPFP C 2BL fadd 125 14m Dotarem SCM LE TPO SP H34 5 ols i Ei D fh a Fa ya A BE er AN Fi NAD A la NN Wi N A h I B we hia Fa ww A EN a i iat Y Br tae pi S es Eu ga N eee is j Vitae E a f ig K d y uci Yol amp ff a LO BI 320 PA NO 1 5T 3T 73 Localization and Biopsy Process 5 Select the distance tool again and measure the distance between the lesion and the reference line that you inserted in step 4 Please note these measure ments on a separate piece of paper In this example the Post amp Pillar positioning unit has to be moved 8 7 mm from the marker zero position to posterior Test Biopsiei 23456 Avanta 11 11 1911 2 103 MR B19 STUDY 1 HFF 47 Gen S LPH 23 IMA FO 6104 1 Distance 10 73 cm 1 Miraz 0 1134 2 Distane Beer 2 Miran 27 SCM MIF 1 00 TR 7 8 TE 4 6 TA 01 31 Ay 349 0 MMORMDISZO AA PFP C 2BL Pac 125 14m Dotarem Pee DWE TPO P A346 SL 1 6i 1040 2565 Tr 318 au Pi ni e ae si ey ay is a Mil rrr T l OA Gv DE gi mer a F E a un BI320 PA NO 1 5T 3T Localization and Biopsy Process 6 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 transversal slices The marker from step 1 is located on slice position SP Slice Posit
22. Adapter for Ethicon SenoRx ATEC Vacora Grid Needle Guide Adapter for Ethicon SenoRx ATEC M Vacora products BI320 PA NO 1 5T 3T Cleaning Disinfection and Sterilization Disinfection au tomated All parts can be d infected by machine the exceptions are alltypes of coils Disinfectant Depending on RDG and Vario TD program you can select one disin fectant which has been ap proved and released for au tomated disinfection IS all coil cables und plugs all patient rests all patient pad coils all insertion plate coils all cushions all head cushions all vacuum mat tresses BI 320 PA NO 1 5T 3T Procedure If automated disinfection is employed a final rinse at 90 C for 5 minutes may be used to effect thermal disin fection The parts such as Needle Guides and Cubes can be disinfected in accord ance with the same proce dure in an ultrasonic bath The assembly should be dis assembled into its individual components so that an opti mal disinfection is guaranteed NORAS mr products Applicable only for Biopsy Set consists of Base Plate Fixation Unit lateral medial Slat Plate vertical amp horizon tal Curved Slat Plate vertical amp horizontal Positioning Unit Post amp Pillar Marker Needle Guide Sleeve Set Grid Localization Cube Set Blocking Plate Auto clave Box Guide Sleeves Post und
23. Breast Biopsy 4 Ch Coil BI 320 PA NO 1 51 31 MR10320 NO 111373 for Immobilization and MR supported Mammography with the NORAS 4 Channel PIC Breast Coil System and PA320 Patient Rest Operator s Manual Rev07 NORAS mr ce products Date issued 07 2015 Technical changes reserved NORAS mrr products BI 320 PA NO 1 5T 3T 2 Content Content 1 General Information e4224220200 00000 000000 ann ann nnnn nun nun nun nun nun nun nun nun nun nn 5 2 nteended sel indicationforuse 0 7 ZA MAAC IONS ANAN NN A nenne NY 8 2 2 7 e ge e gt eg KN A A A PA 8 3 PPG El e e 9 9 1 ale a a a o n hi re a 10 4 DEVICE DOS CTRL G Yasan adlan dn adak 11 41 Definitions and SymbOls za 11 4 121 RAUNG e ee 13 4 2 System componentisS unsseennnnnnenenunnnnnennnnnnenenunnnnsenunnnnenenunnnnsennnnnnenennnnn 15 4 2 1 Patientrestwitihbreastcushionandheadresi 15 L COl a E aka sams RE a iin 16 1253 NORAS Biopsy KI MOdUlAT u een 17 4 2 4 Accessory Cranio Caudal Fixation CC 320 Plus Ref 118341 24 4 2 5 Combination withotherdevices 25 5 SA E MM 27 5 1 Generalinformation eee 27 9 2 PIUG IN ANG UNDIUGGING CONS een 31 5 3 Positiloningofthepatientrest 33 9 31 Read e EE rennen EY
24. E EE 33 992 FPE pr A A DME 30 9 4 Marker TIMING instructions 37 94 OD SMUG Marker rien Een a 37 3 22 PING Malkels urn 37 9 43 GIOSMO Marke een reine 38 3 24 EMD IV ING Ma KOTS een 39 6 LocalizationandBiopsyProcess nun nn 40 6 1 With Post amp Pillar Biopsy System eee eserse 41 6 1 1 Post amp Pillar Adaptor for Ethicon Mammotome MR 81 6 1 2 Application of the Post amp Pillar adaptor for Ethicon Mammotome MR in combination with the Siemens Syngo Biopsy Software 85 BI320 PA NO 1 5T 3T NORAS mrr products Content 6 1 3 Post amp Pillar adaptor for SenoRx Encor 88 6 1 4 Post amp PilaradaptorforSurosATECN 88 6 1 5 Post amp Pillar adaptor for Bard Vacora 88 6 1 6 Multi Purpose Needle Hub Assembly 02200200220000 nn nnn nennen 89 6 2 With Grid Biopsy System nannten 90 6 2 1 Grid Needle Block Adaptor for Ethicon Mammotome MR 99 6 2 2 Grid Needle Block Adaptor for SenoRx Encor ln eee 99 6 2 3 GridNeedleBlockAdaptorforSurosATECN 99 6 2 4 Grid Needle Block Adaptor for Bard Vacora 100 609 MRI Mammography A A A 100 BA Salely NOMAI uses 102 7 Cleaning disinfection and sterilization
25. I320 PA NO 1 5T 3T Technical Specification 9 3 Parts list Patient Rest PA 320 version Noras complete Ref MR10315 NO Patient rest MR10311 og 7 Head Rest Breast gt 112300 4 Ch Bl Breast MR Coil Kit Ref 0 Patient Pad Breast Coil 1 5T MR10380 NO Patient Pad Breast Coil 3 0T 112858 Insertion Plate Breast Coil m A MR10390 SY 1 5T a Insertion Plate Breast Coil 3 T a e 113111 products BI 320 PA NO 1 5T 3T 125 Technical Specification 9 4 Options and Accessories 9 4 1 Compilation of the Biopsy Unit erten Bu u Base Unit for all NORAS BI320 biopsy systems Post amp Pillar Biopsy System 111449 lateral medial cranio caudal Fa Grid Biopsy System lateral 111456 medial cranio caudal Grid Biopsy System Height 112658 adjustable lateral agai 9 4 2 Accessories for Post amp Pillar Biopsy System sesten tain Post amp Pillar positioning unit 111259 with telescope bar autoclava ble and reusable Material PEEK Post amp Pillar needle guide au 111451 toclavable and reusable Materi al PEEK able to be angulated by 15 and 30 Post amp Pillar marker auto 111300 clavable and reusable Material PEEK remove marker liquid before autoclaving and refill af terwards NORAS a BI320 PA NO 1 5T 3T Technical Specification senim u Post amp Pillar needle guide 111298 sleeve set for 18G 16G and 13G autoclavable and reusable M
26. Kr ER a ve I aay Sem N amg A SD q ers 4 E ey w di i vw A vi ae amp I gt X Ne 4 N Fa de zw ewe Em zn ew ry swine iT W iusi F VERE ie r m E a ni EE SE A A ie B C di q a me gi gls ge T W o f oy ry f ET LS u 17 An La S C La BI 320 PA NO 1 5T 3T Me a 71 Localization and Biopsy Process form a biopsy on 3 Scroll through the other slices until you find the lesion that you want to per Test Biopsiei 25456 1141141911 0 103 S TUE 1 17062015 12 36 25 23 lM FO 7104 MIF 1 00 TR 78 TE 48 TA 01 31 Ei 349 0 MNORMDIS20 AA IPFP C 2BL Pac 125 14m Dotarem Avanto MR B19 HFF LFH VB Chirurgie 1 SCM LE TPO P A346 SL 1 6i 1040 2565 Tra i N A Th R 4 in FR 4 R 4 gt iy MZ gt a m a ww y ri E Fi Ding ar a n b i Bi Am Fin Mw GAN oa i zu N kmi a m IN Sn BUZZ f VMRI m ew lt gt m u m lt gt y wu wi g i a s d wi aa Spx j Ki ww asm gis Gm oldeleliledi 3 EE UA GE Ges GC aw u pid We be BI320 PA NO 1 5T 3T Localization and Biopsy Process 4 Right click on this slice and select paste or Strg V Test Biopsie 23456 1141141911 0 103 STUDY 1 1 FOR 2015 12 maa SE Fis i 23 IMA Avanto MR B19 HFF LPH YP Chirurgie 1 70 104 10 73 cm 1134 1 Distance 1 Mira MIF 1 00 TR 7 8 TE 4 6 TA 01 31 Bwy 349 0 YMMNORMDISZO
27. RAS mrr products 98 BI320 PA NO 1 5T 3T Localization and Biopsy Process 6 2 1 Grid Needle Block Adaptor for Ethicon Mammotome MR m For use with the Ethicon Mammotome MR the NORAS company offers reusa ble needle block adaptors made of PEEK These ensure the compatibility of the Mammotome MR Universal Targeting Sets MRU11S MRU11X MRUO8S and der MRUO8X with the NORAS grids The positioning process is described in chapter 6 2 After the successful positioning process of the needle block adap tor and the control scan please follow the Mammotome MR manual from Eth icon 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 adaptors made of PEEK These ensure the com patibility 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 in order to accomplish the biopsy procedure 6 2 3 Grid Needle Block Adaptor for Suros ATEC gt For use with the Suros ATEC Biopsy System the NORAS company offers reusable needle block adaptors made of PEEK These ensure the compatibility of the Suros ATEC Biopsy System cannulas and probes wit
28. Specification 9 Technical Specification 9 1 Historical Device Data Designation model type Product type Device type accord ing to UMDNS DIMDI Breast Biopsy 4 Ch Coil BI 320 PA NO 1 51 31 Surface coil MR 17 542 Manufacturer Supplier NORAS MRI products GmbH NORAS MRI products GmbH Leibnizstrasse 4 Leibnizstrasse 4 97204 Hoechberg 97204 Hoechberg Germany Germany Operation type Test control time limits type active non active yan Product class device class Intended purpose according to in formation provided by the manufac lla per MDD annex IX chapter Ill turer clause 3 paragraph 3 2 rule 10 The device is intended for use during the MRI examination of the female breast Biopsies can also be made with the system Identification number of notified Serial number body C marking 0123 NORAS mrr products BI 320 PA NO 1 5T 3T Technical Specification 9 2 Performance Data Operating temperature Corresponding with the air conditioned room temperature of the MRI room Storage temperature Room temperature Weight Approx 9 kg Dimensions Height 180 mm Width 460 mm Length 740 mm Resonance frequency 1 5 T 63 6 MHz 3 T 123 2 MHz Interfaces Electrical SIEMENS 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 mre products 124 B
29. T Sonata Symphony without TIM 3T Siemens 3T Trio without TIM The patient rest including the 4 Channel Coil System for 1 51 Sonata Symphony and 3T Trio without TIM can be delivered directly from NORAS company The patient rest including the 4 Channel Coil System for Siemens systems with TIM options TIM Symphony Avanto Espree TIM Trio Verio Aera Skyra are sold exclusively via Siemens company The biopsy unit BI 320 with the NORAS patient rest ist suitable for all Siemens systems in case of a Symphony TIM upgrade the biopsy unit BI 320 can also be used with the patient rest delivered by Siemens An upgrade for the Siemens 16Ch coil is possible with the patient rest TIM The Patient Rest with the Immobilization and Biopsy System is primarily intended for use with the NORAS Breast Coil System PIC Pad Insertion Coil patient pad coil and insertion plate coil The patient rest is designed for a permissible maximum patient weight of up to Maximum allowed patient weight 135 kg The maximum permissible patient weight may not be ex ceeded of 135 kg NORAS mre products BI 320 PA NO 1 5T 3T 9 General Information 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 and Biopsy System please send an e mail with the serial number of your
30. a lies right in front of the lesion MF 1 00 30 0 3 R 3 E 1 AN The further biopsy may then be carried out by authorized personnel NORAS mre products 68 BI320 PA NO 1 5T 3T 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 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 the 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 in jure the breast Danger of bruising Be absolutely sure to loosen the slat lateral plates before withdrawing the breast That way bruises or injuries to the patient can be avoided Danger of injury Before loosening and withdrawing the breast you must re move all instruments If all instruments are not removed you may injure the breast of the patient NORAS mrr products BI 320 PA NO 1 5T 3T 69 70 Localization and Biopsy Process c Angulated manual calculation of coordinates for the MR supported breast biopsy with the NORAS Post amp Pillar Biopsy Unit on Siemens MR systems If you prefer performing an angulated biopsy you can adjust the
31. angle with which you want to perform the biopsy in our exam ples e g a 0 b 30 for a a horizontal adjustment b towards nipple adjust ment At all angles always subtract 5cm from the insertion depth in the instruction block marker a stated 8 5 so 8 5 5 3 5cm b stated 10 2 so 10 2 5 5 2 cm a b Date 1007 2009 17 2750 De 0307 2009 172647 prob offy edcsciter horas i 014011970 Verica Move AY 3 on towards nipple MW si Depe 85 cm Series Name Biopsy 0 Leson t_t Background In this way the Siemens Syngo Biopsy Software is informed that the center of rotation of the NORAS Mammotome MR adaptor varies from the standard NORAS positioning device The center is located 68mm not the usual 22 mm behind the tip of the pointer which is visible in the MR image Please consider this when you determinate the insertion depth For selecting and instruction information about the specific targeting sets please look at the operator s manual of your vacuum system manufacturer NORAS mrr products BI 320 PA NO 1 5T 3T 87 Localization and Biopsy Process 6 1 3 Post amp Pillar adaptor for SenoRx Encor mu Please follow the instructions of chapter 6 1 With Post amp Pillar Positioning De vice and the operator s manual of your vacuum biopsy gun gt 6 1 4 Post amp Pillar adaptor for Suros ATEC Please follow the instructions of chapter 6 1 With Post amp Pillar Pos
32. anufac turer for operators patients and third parties NORAS mrr products 8 BI320 PA NO 1 5T 3T Function 3 Function The 4 Channel Breast Coil System described in this document has been designed depending upon model type for use with a MRI system with field strength of 1 5T or 3 0T 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 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 Breast Biopsy 4 Ch Coil BI 320 PA NO 1 5T 3T 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 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 5T or as a 3 0T model 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
33. ar 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 NORAS mrr products BI 320 PA NO 1 5T 3T 121 Maintenance storage and waste disposal 8 2 Storage Following its use and the required cleaning disinfec tion and sterilization the device should be stored at room temperature in a dust free UV radiation protected location min 10 C max 30 C In the case of re sterilized needle sleeves you must not exceed the maximum storage period currently 6 months if stored in single or double packaging in pro tected 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 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 elimi nate 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 NORAS mre products 122 BI320 PA NO 1 5T 3T Technical
34. are wen ISO 7000 0626 Store in a dry place ISO 7000 0632 Temperature Limit ISO 7000 2498 Serial Number BI 320 PA NO 1 5T 3T 11 Device Description IEC 60417 Protective Insulation IEC 60417 Type BF A 5333 8 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 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 number on these plates Conforms with the essential requirements of Council Directive 93 42 EEC of 14 June 1993 concerning medical devices A NORAS mrr products BI320 PA NO 1 5T 3T Device Description 4 1 1 Rating Plates Immobilization 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 out side Patient Rest The rating plate is located on the underside Patient Pad Coil The rating plate is laser engraved on the underside Insertion Plate Coil The rating plate is located on the housing cover Positioning device big punch The rating plate is laser engraved on the gui
35. aterial PEEK also individually acquirable Post amp Pillar needle guide 18G 112654 sleeves for 18G 16G 14G and 12G disposable in sterile pack aging packaging consists of 5 pieces 16G 112597 14G 112655 12G 112653 111242 Base unit fixation plate can be used laterally medially and cra nio 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 and ib 117145 CC Slat plate vertical lateral Mm 117139 Slat plate horizontal medial 111212 and CC MRI products BI 320 PA NO 1 5T 3T 127 Technical Specification nn a Slat plate horizontal high me 118144 dial and CC for thorax proximity interventions Slat plate horizontal lateral 111301 9 4 3 Accessories for Grid Biopsy System an inn Grid markerblock autoclavable 111251 and reusable material PEEK remove marker liquid before au toclaving and refill afterwards Grid needle block set for 18G 111299 14G and 12G used for biopsies 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 reusable material PEEK MRI products 128 BI320 PA NO 1 5T 3T Technical Specification Description Grid biopsy unit height adjust 11
36. aterial may be used En sure that the pack is large enough to contain the instru ment 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 Wrap the trays using appro priate method See also guidance of DGSV RKI and DIN EN ISO 11607 1 NORAS mrr products BI320 PA NO 1 5T 3T Cleaning Disinfection and Sterilization Sterilization Steam sterilization The following parts Only the following items may be subjected to steam may be sterilized nei sterilization ther on basis of STERRAD nor steam sterilization Base Plate Fixation Unit lateral medial Slat Plate vertical amp horizontal Curved Slat Plate vertical amp horizontal Positioning Unit Post amp Pillar Marker plugs Needle Guide Sleeve Set Grid Localization Cube insertion plate coils Set Blocking Plate Au toclave Box Guide Sleeves Post und Pillar Adapter for Ethicon SenoRx ATEC Vacora Grid Needle Guide Adapter for patient rests Ethicon SenoRx ATEC Vacora cushions Procedure head cusions 134 C 3 04 bar 5 min Biopsy Set consists of coil cables and patient pad coils The effectiveness of steam sterilization according to the procedure mentioned above has been validated by Dr Schwarzkopf Markers must be emptied
37. cribed in the Siemens MRI operator s NORAS mrr products BI 320 PA NO 1 5T 3T 31 Start Up Defective coil To remove the plugs only push on the plug cover them selves do not pull on the plugs or on the cables k 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 disinfec tion instructions contained in this operator s manual see chapter 7 Cleaning Disinfection and Sterilization Coils must not be held under water Non compliance with the instructions in chapter Cleaning disinfection and sterilization of this operator s manual may destroy the coils NORAS mrr products 32 BI320 PA NO 1 5T 3T Start Up 5 3 Positioning of the patient rest 5 3 1 Head 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 de sired location and place the wedge cushion on the MRI table in such a way that the cable lie in the cable guide of the cush ion Recess for the cable For more comfortable position ing you can place a foam roll under the patient s legs MRI products BI 320 PA NO 1 5T 3T 33 Start Up Patient positioning Fs p g Place the patient in prone posi tion with the breasts in the
38. de bar lengthwise BI 320 PA NO 1 5T 3T Device Description Needle carriage Ethicon The rating plate is laser engraved on the needle carriage NORAS mrr products 14 BI320 PA NO 1 5T 3T Device Description 4 2 System components 4 2 1 Patient rest with breast cushion and headrest The Patient rest is made of 100 fibreglass The surface has been finished with Alexit The breast cushion and the headrest are made of PE N tn Patient Rest PA 320 Version Noras Ref MR10311 Breast Cushion Head Rest Art Nr 112297 Art Nr 112300 NORAS mrr products BI 320 PA NO 1 5T 3T Device Description 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 rigid plastic material IPC Insertion Plate Coil 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 Sn PPC Patient Pad Coil N a N 2m NORAS mrr products 16 BI320 PA NO 1 5T 3T Device Description 4 2 3 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 and Pillar Higher accuracy compared to grid biopsy Angulation is poss
39. dle 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 Danger of penetration through the breast Should under exceptional circumstances the needle be bent while being in the breast e g if the needle should strike one of the three horizontal slats after penetrating through the breast then clip off the distally deformed needle end with a suitable MRI compatible tool and remove the remaining tro Car Withdrawal of the bent end section of the needle would cause injury to the breast NORAS mrr products BI 320 PA NO 1 5T 3T 97 Localization and Biopsy Process Danger of injury Before loosening and withdrawing the breast you must re move all instruments If all instruments are not removed you may injure the breast of the patient Danger of bruising Be absolutely sure to loosen the slat lateral plates and com pression plates before withdrawing the breast In this way bruises or injuries to the patient can be avoided Danger of bruising Be absolutely sure to loosen the slat lateral plates and com pression plates before withdrawing the breast In this way bruises or injuries to the patient can be avoided e After completion of the biopsy clean the device parts as described in chapter 7 Cleaning Disinfection and Sterilization NO
40. e abrasive cleaners or 1 Rinse excess soil from other organic sol components vents and solvent based cleaning agent e g benzene alcohol stain remov ers may not be used 2 Using soft brush apply de tergent solution to all surfaces ensuring that hinged compo nents are cleaned in both open and closed positions 3 The part is held under run ning water for 5 minutes In this case the running water must flow through the cannu las 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 af MR products BI320 PA NO 1 5T 3T Cleaning Disinfection and Sterilization For manual disinfection it is advisable to insert the parts for expected parts see left column in the solution imme diately after use Ensure that the parts are completely sub merged in the solution Take the parts from the solution after the described time 15 minutes and rinse by water the quality of water must be at least equal to drinking wa ter better would be using ag ua Demineralized water Changing in color due to con tinuous disinfection cannot be excluded but can be largely prevented by sufficient rinsing after each use The solution is distributed on the surfaces by a fluff free cloth The disin fectant permeates the dirt par ticles and because of mechan ical forces pressure abra sion this
41. ead start ing at the bottom of the marker Rotate the syringe during filling to prevent the formation of bubbles NORAS mrr products BI 320 PA NO 1 5T 3T 37 Start Up Grid Markerblock Bolt marker Marker inside the grid cartridge marker r 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 MRI compatible screwdrivers If no MRI compatible screwdrivers are available you must fill the oil marker outside of the MRI room NORAS mrr products 38 BI320 PA NO 1 5T 3T Start Up Test measurement Test marker imaging by installing the biopsy system and taking a test meas urement 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 5 4 4 Emptying markers Markers must be emptied prior to sterilization To empty them open the mark ers as described above and empty them Caution Marker liquid is harmful see warning instruction Use a syringe filled
42. ective gloves and carefully comply with the application times for Hepatitis B and HI viruses See the instructions for use of the respec tive disinfectant solution Limitations on re Frequent processing can have an impact on these processing products color changes but do not affect the function of the product Frequent processing can have an impact on these products color changes but do not affect the function of the product Please always wear protective gloves and comply with the application times for Hepatitis B and HI viruses See the in structions for use of the respective disinfectant solution NORAS mrr products 104 BI320 PA NO 1 5T 3T 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 Transport the processing of the product as soon as possible after its use The products must be transported in a closed con tainer Preparation for No particular requirements If necessary the assembly Cleaning must be disassembled into its individual components Needle blocks and needle guides sleeves could possibly be pre cleaned by syringe or water nozzle Cannulas and wholes must be connected in accordance to rinse body Pay attention to correct flow Preparation with H202 or enzymatic cleaner could be done NORAS mrr products BI 320 PA NO 1 5T 3T
43. ed 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 biopsy 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 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 NORAS mrr products BI 320 PA NO 1 5T 3T 29 Start Up The cable trap must be aligned as closely as possible parallel to the magnet opening and not perpendicular to it Cable trap NORAS mrr products 30 BI320 PA NO 1 5T 3T Start Up 5 2 Plug in and unplugging coils Plug in both coil plugs into the connections provided on the MRI table 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 produced The Breast Biopsy 4 Ch Coil BI 320 PA NO 1 5T 3T is recognized by the MRI software The software operation is des
44. ensures effective cleaning Additionally the wip ing motion ensures that spores which are resistant to the disinfectant will be re moved The cloth must be re placed after the disinfection in order to prevent the spreading of the spores on other areas Moreover it is essential that the wiping solution is renewed regularly daily NORAS mrr products BI 320 PA NO 1 5T 3T 110 Cleaning Disinfection and Sterilization Danger of Destruction The coils must not be cleaned in immersion baths or held under running water Non respect of the cleaning instructions may cause the destruction of the coils Danger of Destruction The coils must not be cleaned in immersion baths Non respect of the disinfection instructions may cause the destruction of the coils When drying is achieved as part of washer disinfector cycle do not exceed 50 C Maintenance __in Blunt or damaged parts should be discarded Hinged spection and func parts Check for smooth movement of hinge without ex tion testing 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 Singly A standard packaging m
45. f the Siemens Syngo Biopsy Software the block marker replaces the regular needle guide girder with mounted pointer Installing horizontal O position Subsequently the guide bar has to be set in the scaled guide rail The right indicator must be installed at 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 O position The vertical O position is indicated by the upper edge of the fiducial holder and the O base at the guide bar For height adjustments anterior posterior please adjust the fiducial holder at the requested position and close the adjustment screw see ill above NORAS mrr products BI 320 PA NO 1 5T 3T 85 Localization and Biopsy Process 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 see green cross in ill 1 and then press Store Marker Ill 1 green cross Stere Marker Position f Store Legon Poston To register the lesion click on the target point for the biopsy as usual and con firm the reference point with Store Lesion Position ill 2 NORAS mrr products 86 BI320 PA NO 1 5T 3T Localization and Biopsy Process Then select the
46. h Coil BI 320 PA NO 1 5T 3T can be used with the following MRI systems 1 5T Siemens 1 5T Sonata Symphony withou TIM 3 0T Siemens 3 0T Trio without TIM The patient rest including the 4 channel breast coil system can be delivered for 1 5T Sonata and 3 0T Trio without TIM directely from NORAS MRI products GmbH The patient rest including the 4 channel breast coil system for SIEMENS devices with TIM options is distributed exclusively from SIEMENS Special NORAS adaptors are available for the use with Bard Vacora Suros ATEC and SenoRx EnCor biopsy systems The respective adaptors for the grid system must simply be inserted in the desired position of the grid Be sure that the adaptors are firmly seated With the help of the MRI software you can determine the correct gauge hole through which the needle must be guided The post and pillar adaptors 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 Localization and Biopsy Process Combination with other devices The Breast Biopsy 4 Ch Coil BI 320 PA NO 1 5T 3T can 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 manufac
47. h 9G 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 Suros ATEC Biopsy System manual in order to accomplish the biopsy procedure NORAS mrr products BI 320 PA NO 1 5T 3T 99 Localization and Biopsy Process Wee gt gi u For use with the Bard Vacora Vacuum Biopsy System the NORAS company offers reusable needle block adaptors made of PEEK These ensure the com patibility of the Bard Vacora Vacuum Biopsy System cannulas and probes with10G 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 Bard Vacora Vacuum Biopsy System man ual in order to accomplish the biopsy procedure 6 2 4 Grid Needle Block Adaptor for Bard Vacora 6 3 MR Mammography Permanent damage to the system The system may only be assembled by trained medical personnel Incorrect assembly and operator errors made by un trained personnel 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 diag nosis of the left and right breast is described Insert base plates into the insertion plate co
48. hen using the Breast Biopsy 4 Ch Coil BI 320 PA NO 1 5T 3T 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 per sonnel Incorrect assembly and operators errors made by untrained personnel can permanently damage individual parts of op tional components and of the device itself NORAS mrr products BI320 PA NO 1 5T 3T 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 mr products BI 320 PA NO 1 5T 3T 103 Cleaning Disinfection and Sterilization 7 Cleaning Disinfection and Sterilization The procedure must be followed as described In case of inadequate cleaning disinfection or steriliza tion you carry the risk of infection Non compliance with the cleaning instructions may destroy the system No warranty service will be pro vided for damages due to improper disinfecting Please always wear prot
49. ible NL 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 products BI 320 PA NO 1 5T 3T 17 Device Description Grid Method with Grid Biopsy System lateral medial cc Perform several biopsies or wire placements at various lesions in one step Sg l disposable reusable gt 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 Please note that this rotation radius does not apply if the Siemens Syngo software is in use Grid needle blocks can be freely positioned in the grid to ensure needle guidance The cubes are availa ble as reusable autoclavable or disposable sterile accessories NORAS mrr products BI320 PA NO 1 5T 3T Device Description Grid Method with Grid Biopsy System Height Adjustable lateral Perform several biopsies or wire placements at various lesions in one step 3 disposable reusable The Grid B
50. 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 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 artefact is notable when using plastic cannulas and re moving the trocar Having removed the trocar close the cannula using the pro vided 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 penetrate with the needle to the lesion e 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 in serting the cannula When using a plastic cannula the metal trocar has to be replaced by the provided plastic stick NORAS mrr products 96 BI320 PA NO 1 5T 3T Localization and Biopsy Process Needle penetration at incorrect location Please take care of using a needle with the appropriate size gauge as well as the corresponding needle guide In case of extreme small needle sizes the lesion may be missed In case of extreme large nee
51. ight S7 Ill similar products 114 BI320 PA NO 1 5T 3T Maintenance storage and waste disposal If you want to position the patient rest for a feet first measurement in a MRI scanner without a whole body option that is a scanner in which the table can not be fully transported through the scanner the center of the bottle may be positioned at maximum at the end of sector S7 see above illustration To prepare for the measurement first align the laser sight on the bottles central ly 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 Sie mens gre gradient echo sequence axially centered through the bottles You can find this sequence under Siemens Sequence Region Siemens Sequenc es Default Protocols gre Centrally align the laser sight between the loops NORAS mrr products BI 320 PA NO 1 5T 3T 119 116 in System Add On Patient Anwendungen Transfer Bearbeiten Warteschlange Noras Brustspule 2007 Noras Brustspule 2007 1 IMA 1 5 01 08 2007 M DIS2D Localizer Start Region Daniel Gareis ocalizer Start Untersuch Localizer localizer Brustspule axial tse Brustspule localizer links localizer rechts tse an einer Seite localizer links rechts localizer sag Flasche Body Warten auf Programmanweisungen Sequence Maintenance storage and waste disposal Optionen Hilfe
52. il 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 mrr products 100 BI320 PA NO 1 5T 3T Localization and Biopsy Process 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 e Position the patient on the patient rest and immobilize the breast to be exam ined by pressing 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 exami nation 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 se quence Perform the MR mammographic procedure Danger of bruising Be absolutely sure to loosen the slat lateral plates and com pression plates before withdrawing the breast To do so simultaneously push the left and right slides and pull the lat eral slat plate outwards In this way bruises or injuries to the patient can be avoided NORAS mrr products BI 320 PA NO 1 5T 3T 101 102 Localization and Biopsy Process 6 4 Safety information Please consider the following w
53. ine from the software toolbox of your MRI system Go back to the slice where you can see the marker block and the impression of the grid NORAS mrr products BI 320 PA NO 1 5T 3T 93 Localization and Biopsy Process 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 plane as the le sion MRI products 94 BI320 PA NO 1 5T 3T Localization and Biopsy Process When the marker block and the lesion are in the same plane determine the distance between the skin and the lesion using your toolbox Distance tiefe Penetration danth NORAS mrr products BI 320 PA NO 1 5T 3T 95 Localization and Biopsy Process e Push the needle block with the desired diameter 12G 14G or 18G into the corresponding opening in the compression plate and using the toolbox deter mine the desired penetration point on the needle block e Select the needle block with the proper size needle and mount these in the specified position Select a needle with an appropriate length to reach the le sion Consider addition of the offset approximately 25mm to the distance skin lesion Insert the needle to a position approx 10mm in front of the lesion 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 additional anesthesia
54. ing the coordinates manually and after removing the raster pin Ill Post amp Pillar Version 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 Process and the correct result illustrated in the text NORAS mrr products 10 BI320 PA NO 1 5T 3T Device Description 4 Device Description 4 1 Definitions and Symbols The following symbols are used on the Breast Biopsy 4 Ch Coil BI 320 PA NO 1 5T 3T and in this operator s manual ISO 7000 2497 Date of Manufacture DIN EN 980 Operator s Manual EN ISO 7010 Differ to the requirements of EN ISO 701 Moo2 M002 all laser engravings can only be executed in grey instead of blue due to technical unfeasibility ISO 7000 Caution read the accompanying 0434B documents Directive Waste products should not be disposed of 2002 96 EC with household waste e g at a local authority collection point ISO 780 DIN 55402 way up ISO 7000 0621 Fragile handle with c
55. ion F24 4 therefore 24 4 mm towards the feet from the mark er zero position est Biopsiet 23456 Avanta 11411911 0 103 MR B19 HFF STUDY 1 FMB 2015 ME EER VE Chirurgie 1 ee RE JE 3 IMA 33104 SCH Fr 1 00 R 7 E 45 a0 31 er adan WMORMDIS 2D n iPFP 4 B y 2DL 14ml Dotarem I 375 ac 125 EE p if A Eh on ya a BE AR fg fet Fi g A b li a Al hi am i 5 i e A gr N ek sy ha Ae A Ti J a N uh Mi A N b gt i nAg VIN Aaa u a f g i 4 1 va ere tj D id D d y u IGL amp BI 320 PA NO 1 5T 3T VW m 19 Localization and Biopsy Process 7 The lesion you have chosen in step 3 is located in our example on slice posi tion H34 8 Hence the sum is 24 4 34 8 59 2mm In order to reach the lesion you have to move the Post amp Pillar positioning unit by 59 2 mm towards the head Test Biopsiet 23456 Avant 1141141911 0 103 MR B19 STUDY 1 en 1706 2015 Taya seat ehe TEDE VE Chirurgie 1 23 MA 702104 MIF 1 00 TR 7 8 TE 4 6 TA 01 31 Ay 349 0 MINOR MDS 20 184p 256s AA IPFP a C 2BL 14ml Dotarem Tra flad1 125 i lV 4 y m E di Db 4 a N s i 1 g l M l A iy a i A cn 7 j u h N E i 5 a gt Gi it iy m m g i ee iene Zu m ww Fin ie va x Bi k v AE A nl A Mt 1 4 Eu a l i u way af 2 ew E EVIEIRZ A g a B Me ww g et 1 MP in mil e m m Gl ae Wi nHrogculicirese 4 EY Bi pid ur l 76 Y BI32
56. iopsy 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 BI 320 PA NO 1 products PAs 931 20 Device Description Grid Method with Grid Biopsy System Height Adjustable lateral medial cc disposable Perform several biopsies or wire placements at various lesions in one step 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 contact 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 mrr products
57. itioning De vice and the operator s manual of your vacuum biopsy gun Please follow the instructions of chapter 6 1 With Post amp Pillar Positioning De vice and the operator s manual of your vacuum biopsy gun 6 1 5 Post amp Pillar adaptor for Bard Vacora Please note regarding from chapter 6 1 3 until 6 1 5 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 autoclaved The needle guide sleeves need to be sterilized autoclave meth od 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 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 nqw be taken NORAS mre products 88 BI320 PA NO 1 5T 3T Localization and Biopsy Proce
58. ization and Biopsy Process 10 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 52 1 mm Subtract an offset depending on the biopsy system normally about 5 10 mm in order to position the cannula lie in front of the lesion Now puncture the breast with the trocar using this offset corrected depth start ing 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 Test Biopsiet 23456 Avanta 7 1111911 Oo 10537 MF B19 STUDY 1 ans 1708 2015 ya EE Mi 12 36 28 an eneu 23 MA FO 104 1 Distance 5 27 cm 1 Mirhan 5 1391 Offset Sc MF 1 00 TR r a DE TE 4 m IP I TA 01 59 SP H346 EYY 349 0 _SL18 a 20 Fow Si AA PFP Tep n a OL 14ml Dotarer s18 sc 125 Fe M PA i aa BIARRA A A mu NM 5 Au Q gi he Si MN N gt 4 N a MR GE ie wwe wwe An a O T fj NA WU am e A uS E y He ei m u WW as u ee g f ij Y By m n z i Ni a ni EE SE A Hy E 1 F i g Be gam 1 g a Yy wi fl PTG amp D r 0 0 E iy a i be BI 320 PA NO 1 5T 3T V 79 80 Localization and Biopsy Process 11 Perform a control scan in order to check that the end of the needle is posi tioned in front of the lesion The further biopsy may then be carried out by authorized person
59. lateral guide bar j A 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 Guide Bar Fiducial Holder Needle Guide Girder Pointer te Guide Fork Ethicon E s r l heia scaled Guide Rail Guide Plate O 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 products BI 320 PA NO 1 5T 3T 81 Localization and Biopsy Process For horizontal biopsies no angulations 0 the handling of the NORAS Mammotome TM adaptor is equal to the standard NORAS positioning devices For angulated biopsies please note that the center of rotation varies from the standard NORAS positioning devices The center is located 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 coordinates 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 a
60. lization 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 the 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 in jure the breast Danger of bruising Be absolutely sure to loosen the slat lateral plates before withdrawing the breast That way bruises or injuries to the patient can be avoided Danger of injury Before loosening and withdrawing the breast you must re move all instruments If all instruments are not removed you may injure the breast of the patient NORAS mrr products BI 320 PA NO 1 5T 3T 9 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 Siemens MR systems Perform the steps 1 to 10 from the user manual for the straight manual calcu lation 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 angulated biopsy for any other reason you can also work with an angu lation of 15 or 30 degrees toward the top or the bottom 13 Now an angle of 15 degree
61. nel 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 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 the 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 in jure the breast Danger of bruising Be absolutely sure to loosen the slat lateral plates before withdrawing the breast That way bruises or injuries to the patient can be avoided Danger of injury Before loosening and withdrawing the breast you must re move all instruments If all instruments are not removed you may injure the breast of the patient NORAS mrr products BI320 PA NO 1 5T 3T Localization and Biopsy Process 6 1 1 Post amp Pillar Adaptor for Ethicon Mammotome MR In application with the Ethicon Mammotome 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 cranio caudal guide bar
62. plies 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 immobilization device and a second grid on the other side and proceed in the same way NORAS mrr products 90 BI320 PA NO 1 5T 3T 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 fixa tion 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 breast 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 products BI 320 PA NO 1 5T
63. prior to sterilization Storage Safe dry dust free and protected from light Constant temperature 23 C 2 C Constant humidity below 60 rel humidity Additional informa When sterilizing multiple instruments in one autoclave tion cycle ensures that the sterilizers maximum load is not exceeded Manufacturer See chapter 10 contact NORAS mr products BI 320 PA NO 1 5T 3T Cleaning Disinfection and Sterilization Danger of Destruction Non respect of the disinfection instructions may cause the destruction of the device No warranty service will be provided for damages due to improper disinfection Improper disinfection may re sult in malfunction of the device A Danger of infection The disinfection instructions must be followed In case of inadeguate disinfection the risks of infection arise to user and or end user G13 G36 Danger of Destruction Non respect of the sterilization instructions may cause the destruction of the device No warranty service will be provided for damages due to improper sterilization Improper sterilization may re sult in malfunction of the device Danger of infection The sterilization instructions must be followed In case of insufficient sterilization the risks of infection arise to user and or end user G14 G37 NORAS mrr products 112 BI320 PA NO 1 5T 3T Maintenance storage and waste disposal 8 Maintenance storage and waste disposal
64. products 47 Localization and Biopsy Process 3 Draw a line straight through the pointer A MRB Forschungszentrum fuer Magnet Resonanz ra MR BT HFP LPH 4 E 4 Ajr 7 Distanz ezin Min MERSEDEIBTE MRI products 48 BI320 PA NO 1 5T 3T Localization and Biopsy Process 4 Mark that line with a left click and select the marked line with a right click In the context menu select copy By doing so the line is copied and can be pasted into other slices Manual Biopsy A MRB Forschungszentrum fuer Magnet Resonanz ae 01 01 1980 O 31Y MR D11 STUDY 1 HFP ech nn IMA 20 35 Ausschneiden Kopieren Einf gen L schen Markieren 12 14 10 Eigenschaften Kommentar editieren R 1 E 1 Distat Mesai 1 Min NORAS mrr products BI 320 PA NO 1 5T 3T 49 Localization and Biopsy Process 5 Scroll through the other slices until you find the lesion that you want to per form a biopsy on Right click on this slice and select paste A MRB Forschungszentrum fuer Magnet Hal Serie ausw hlen Alle Folgenden ausw hlen Markierte Objekte ausw hlen Nicht markierte Objekte ausw hlen Kopieren Einf gen Markieren Dokumentle entfernen Zur ck zu Originalfensterwerte In Segment einpassen Zur ck zur Originalgr e Position Fensterwerte speichern Kommentar editieren MRI products 50 BI320 PA NO 1 5T 3T Localization and Biops
65. r and the angulation angle of the needle guide of the Post amp Pillar positioning unit in horizontal and vertical direc tion to zero see ill below NORAS mrr products BI 320 PA NO 1 5T 3T 43 Localization and Biopsy Process Marker in center of device Set angulation an gle guide base and guide bar to 0 po sition e Now mount the Post amp Pillar positioning unit onto the pins of the fixation plate NORAS mrr products 44 BI320 PA NO 1 5T 3T Localization and Biopsy Process NORAS mr products BI 320 PA NO 1 5T 3T 45 46 Localization and Biopsy Process a Manually calculation of coordinates for the MR supported breast biopsy with the NORAS Post amp Pillar Biopsy Unit on Siemens MR systems 1 Perform a measurement with transversal slices and look for the slice where you can see the marker Manual Biopsy A MRB Forschungszentrum fuer Magnet Resonanz r a 01 01 1980 O 31Y MR D11 HFP LPH NT BW 130 0 M NORM DIS2D 2BL 2BR tse2d1_7 180 BI320 PA NO 1 51 3T 01 01 1980 O 31Y Localization and Biopsy Process 2 Start the distance tool menu right center Extras distance ruler Manual Biopsy A MRB Forschungszentrum fuer Maanet Resonanz 3 Skyra Eg vi ay Al may 1 fae Manual Biopsy 4 14 1 0 IMA 20 35 Ng LPR Extr is NG 2BL 2BR tse2d1 7 180 BI 320 PA NO 1 5T 3T MRI
66. rr products BI 320 PA NO 1 5T 3T 131 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 www noras de NORAS mre products BI 320 PA NO 1 5T 3T 132 Operator Training Outline 11 Operator Training Outline have reviewed the Breast Biopsy 4 Ch Coil BI 320 PA NO 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 Ch Coil BI 320 PA NO user manual will read or have read this appropriate manual including the Cleaning and Disinfecting section of the manual understand the indications for use and the functionality of the System Breast Biop sy 4 Ch Coil BI 320 PA NO and am aware of the components of the Breast Biopsy 4 Ch Coil BI 320 PA NO the installation of the Breast Biopsy 4 Ch Coil BI 320 PA NO the complete setup of the Breast Biopsy 4 Ch Coil Bl 320 PA NO the Localization and Biopsy Process the connection to the MRT the application on patients the cleaning instructions the disinfection instructions the sterilization instructions that it is NOT NORAS responsibility for timely replacement of worn out parts NORAS mre product
67. s BI 320 PA NO 1 5T 3T 133 Operator Training Outline Tite Name Department Date amp Signature Contact Person E Mail Address Phone No nn Trained by NORAS Application Trainer Date amp Signature NORAS mre products 134 BI320 PA NO 1 5T 3T Notes Your notes NORAS mrr products BI 320 PA NO 1 5T 3T 135 Notes NORAS mrr products 136 BI320 PA NO 1 5T 3T
68. s 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 adaptor is compatible with the Ethicon Holder for the reception of the Ethicon Mammo tome MR Universal targeting sets MRU11S MRU11X MRU08S und MRUO8X Danger of injury and delocalization The purpose of the NORAS Mammotome 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 indi vidually into the control scan The adaptor is not capable of carrying the weight of the vacuum system individually During the control scan the Mammotome MR targeting set must not Slip NORAS mrr products 84 BI320 PA NO 1 5T 3T Localization and Biopsy Process 6 1 2 Application of the Post amp 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 Soft ware the MR10017 ET 10 block marker is required see ill Special designed pointer MR10017 ET 10 for application in combination with Siemens Syngo Pointer on 0 position for the right side left analogical 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 o
69. s in this example has to be drawn to the origi nal marker line To do so one needs to use the tool which you find on the right hand side under Extras angle Manual Biopsy A MRB Forschungszentrum fuer Magnet Resonanz E3 ra 01 01 1980 O 31Y MR D11 HFP LPH 4 or O 3 MF 1 00 S Q TR 3710 0 J TE 13 0 J m TA 02 09 se 30 ES ar MRI products 60 BI320 PA NO 1 5T 3T Localization and Biopsy Process 14 Draw the first line in this example from right to left through the marker toward the lesion NORAS mrr products BI 320 PA NO 1 5T 3T 61 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 1 Winkeligsterzd NORAS mr products 62 BI320 PA NO 1 5T 3T Localization and Biopsy Process 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 MRI products BI 320 PA NO 1 5T 3T 63 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
70. s of the pa tient To avoid this please place an ade quate cushion between the hands Use adequate positioning cushions NORAS mr products 36 BI320 PA NO 1 5T 3T Start Up 5 4 Marker filling instructions The product is delivered with 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 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 MRI compatible screwdrivers If no MRI compatible screw drivers are available you must fill the oil marker outside of the MRI room Post amp Pillar Marker Fiducial Bolt Marker with Grid Cartridge Marker and Grid Marker Block 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 thr
71. s well as posterior angulations are possible for 15 and 30 After the angulations adjustment close the adjustment screw slowly until the new position of the fiducial holder is fixated Height and angle adjustment screw Clamping screw Targeting Set MRI products 82 BI320 PA NO 1 5T 3T Localization and Biopsy Process In case of a very anterior lesion position the guide fork Ethicon can be seton 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 position 0 position of the pointer 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 lesion 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 please look at the manual of your vacuum system manufacturer Secondary Z rail N products BI 320 PA NO 1 5T 3T 83 Localization and Biopsy Process Bodily injuries due to accessorie
72. ss Please make sure that when using plastic cannulas that no artifact is noted after removing 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 6 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 products BI 320 PA NO 1 5T 3T 89 Localization and Biopsy Process 6 2 With Grid Biopsy System 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 Training of personnel The users must be trained before using the device de tailed training of the personnel for existing components G22 G42 The localization process with medio lateral alignment of the immobilization de vice lateral access and the use of the sagittal slices is next described This ap
73. ssible 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 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 products 42 BI320 PA NO 1 5T 3T Localization and Biopsy Process Cranial Caudal access e To enable cranial caudal access proceed as described previous to provide medial lateral access Please note that when the biopsy device is turned into the cranio caudal direc tion the MRI images must be made in the sagittal direction to correspond with the following description 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 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 e Screw the filled marker into one of the needle guides on right or left side and reset the scales of the guide base guide ba
74. tspule 2007 Noras Brustspule 2007 1MA175 01 08 2007 nyons 9jun Localizer Start Store separately TA 0 14 PM REF PAT Aus Voxelgr e 2 8x7 8x5 0 mm Rel SNR Noras Brustspule 2007 01 01 1980 44 Abbrechen mmm e Unkombiniert speichern r Positionierungs Modus REF zl Matrix Spulen Modus Auto CP Tischposition Tischpositionsged chtnis Bildnummerierung MSMA S C T Sagittal R gt gt L Coronar A gt gt P BZ Transversal F gt gt H v SM Bale NM 01 08 2007 16 41 12 Warten auf Schichtpositionierung Now you can start the measurement NORAS mrr products BI 320 PA NO 1 5T 3T 119 Maintenance storage and waste disposal The single channel images should be shown in the viewer similar to the follow ing Scan Assistant 9 Ihre letzte nderung Unkombiniert speichern Aus wird die folgenden Parameter anpassen Kanalkombination Adaptive Combine gt Quadratsumme gt 00 00 za Uberspringen re outine Kontras SAR NM The illustration shows that the four coils channels are producing a good quality artifact free signal NORAS mrr products 120 BI320 PA NO 1 5T 3T Maintenance storage and waste disposal Display of four channels atient Anwendungen Transfer Bearbeiten Ansicht Bild Extras Bl ttern Auswertung System Optionen Hilfe Pe Noras Brustspule 2C 01 08 2007 16 44 22 If the images produced during your measurement appe
75. turers is only permitted with the express written approval of NORAS MRI products GmbH NORAS mrr products BI 320 PA NO 1 5T 3T 25 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 NORAS mrr products 26 BI320 PA NO 1 5T 3T 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 electron ic components 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 Ch Coil BI 320 PA NO 1 5T 3T Operating errors may cause permanent damages to the device coil Bodily injuries Only trained personnel may be assigned to handle the Breast Biopsy 4 Ch Coil BI 320 PA
76. with distilled water to rinse out the markers starting at the bottom of the marker to remove any residual marker lig uid Then dry them or open and place them in upright position within in the steam autoclave Health hazard for operator Marker liquid is harmful Please note the warnings NORAS mrr products BI 320 PA NO 1 5T 3T 39 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 fixation 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 mounted The screws are only necessary as additional fixation of the grid for the lateral application The medial grid is always mounted in the lowest possible position It is sufficiently 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 direction Only with this application the screws are necessary for a safe fixation NORAS mre products BI 3
77. y Process 6 Select the distance tool again and measure the distance between the lesion and the reference line that you inserted in step 5 Please note these measure ments on a separate piece of paper In this example the Post amp Pillar positioning unit has to be moved 22 mm from the marker zero position to anterior because the patient is lying in the prone position Manual Biopsy 7 a aad lt ee ne a 7 kyra D11 FP PH 7 a A a 01 01 1980 O 31Y Qe Manual Biopsy A Bj 7 ZA Z alen sieges ek erp TM a Aleve U ZU anze APGA Aleve U 72U73 MRI products BI 320 PA NO 1 5T 3T 51 52 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 transversal slices The marker from step 1 is located on slice position SP Slice Position H7 0 therefore 7 mm towards the head from the marker zero position A MRB Forschungszentrum fuer Magnet Resonanz ra MR 34 1 HFP LPH v SSeS FoV 150 150 252 256 0 09 0 0 M DIS2D BI320 PA NO 1 51 3T Localization and Biopsy Process 8 The lesion you have chosen in step 5 is located in our example on slice posi tion H25 0 Hence the difference is 25 7 18mm In order to reach the lesion you have to move the Post amp Pillar positioning unit by 18 mm towards the head

Manual BI 320-PA-NO - Noras MRI products

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