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Manual BI 320-PA-PH - Noras MRI products

1. Breast Biopsy Patient Rest BI320 PA PH p r O d u C ts 10 Device Description Conforms to the essential requirements of Council Directive 93 42 EEC of 14 June1993 concerning medical devices Warning regarding risks that may result in minor physical injury or material damage Warning regarding risks that may result in death or serious physical injury Information regarding the optimal use of the product On the following page we describe where you can find our various rating plates on your product In addition to the above described symbols you will also find the mod el product and serial number on these plates NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O d u C ts 11 Device Description 4 1 1 Rating Plates Base Plate The rating plate is located on the underside Grid Biopsy Unit lateral medial cranio caudal The rating plate is located on the upper right Post amp Pillar Positioning Unit The rating plate is located on the telescopic square outside Patientenauflage The rating plate is located on the underside NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 12 Device Description 4 2 System Components 4 2 1 Patient Rests 4 2 1 1 MR10320 PH The patient rest is made of 100 fiberglass The surface has been finished with a biocompatible two component coating Alexit 4 2 1 2 MR10320 PH 2 The patient rest consists of two parts an u
2. Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 30 Start Up Test Measurement Test marker imaging by installing the biopsy system and taking a test measurement The markers must be homogeneously imaged They must not exhibit any holes which are air bubbles which can also be recognized as a kink in the marker lf the marker cannot be imaged as a straight line then change the phase code direc tion during imaging and verify the changed settings 5 4 4 Emptying Markers Markers must be emptied prior to sterilization To empty them open the markers as described above and empty them Caution Marker liquid is harmful see warning in struction Use a syringe filled with distilled water to rinse out the markers starting at the bottom of the marker to remove any residual marker liquid Then dry them or open and place them in upright position within in the steam autoclave Health hazard for operator Marker liquid is harmful Please note the warnings NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 31 Localization and Biopsy Process 6 Localization and Biopsy Process The biopsy procedure is based upon the safety concept described in chapter 3 Function Compliance with this concept is mandatory Permanent damage to the system The fixation screws should be removed from the basic unit fixa tion plate during medial application In case of a higher load on the patien
3. NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 37 Localization and Biopsy Process a Manually calculation of coordinates for the MR supported breast biopsy with the NORAS Post amp Pillar Biopsy Unit on Philips MR systems 1 Perform a measurement with transversal slices and look for the slice where you can see the marker Breast Biops y Fallent REST DIOZU FA F A Localization and Biopsy Process 2 Start the distance tool right clicking gt Line Distance Profile Hardcopy Image Remove Image View Reset Window Reset ROI Rectangle Annotate Text More Rraact Rinney Datiant Ract RI29N_DA_DU Dreast Bio DOSY Frallent Kest DBISU FA FN Localization and Biopsy Process 3 Draw a line straight through the pointer Rraaget Rinnevyv Patiant Raet RI2IN_PA_PEK Dreast BIOPSV ratlent REST DIOZU FA I Ze Localization and Biopsy Process 4 Mark this line with a right click and select Copy All in the context menu Thus the line will be copied and pasted into other slices 82064 Profile Copy Next Copy Previous Copy Right Copy To Temp Delete Delete All Rename Draanct Dinneiv Datiant Daat DIA9N DA Di Dreast BIOPSV ratient REST DIOZU FA I Localization and Biopsy Process 5 Scroll through the other slices until you find the lesion that you want to perform a biopsy on Localization and Biopsy Process 6 Select the
4. 7 A IFTA AF AI A ms PM MA FRA A rA A A A A f M A y F Tar y A AN mn FARK OUI are HOLOS N A a DOA Ie OM ALITTI SECU DerSONre Localization and Biopsy Process Control scan shows large or no image distortion Please pay attention to removing the metal trocar when inserting the cannula When using a plastic cannula the metal trocar has to be replaced by the provided plastic stick Needle penetration at incorrect location Please take care of using a needle with the appropriate size gauge as well as the corresponding needle guide sleeve In case of extreme small needle sizes the lesion may be missed In case of extreme large needle sizes there is a risk of damage to the needle Insufficient penetration depth Please take care of using a needle with the appropriate length 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 mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 61 Localization and Biopsy Process Danger of penetration through the breast Should under exceptional circumstances the needle be bent while in the breast e g if the needle should strike one of the three horizontal slats after penetrating through the breast the clip of
5. Breast Biopsy Patient Rest BI320 PA PH for Immobilization and MR supported Mammography with the NORAS Patient Rests MR10320 PH MR10320 PH 2 I T L a O N Se m a Oo oO D gt v O 2 an o qu Oo C cn Operator s Manual Revision 08 NORAS mr ce pr O d u C ts Technical changes reserved Date issued August 2015 NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 2 Content Content 1 General Informa tlO es a a a 5 2 Intended Use Indication for Use ss 7 2 1 PVG QUO Sse E E a a do E seuss eresseren 8 2 2 Contraindication nn ne eee tn oi ei re a tion 8 3 OR ieee etc enc eaten ese ee see eee 9 3 1 SE LIEN CONC ann ann tte ete E EE ae 9 4 Devi DOSS DUO ne de De 10 4 1 Definitions and 5 VIMDONS ana asia sense ie 10 EL RO PINOS ee De eee ee 12 4 2 SV SUS Wy OID OCIS nan eee es de ee sence E AEE 13 AZ PAU ROS OE E E E 13 42 2 NORAS Biopsy KIFMOQUIAR 2 oser ec 14 4 2 3 Accessory Cranio caudal Fixation Unit for Breast Biopsy Patient Rest BI320 PA PH Artikel Nr 111905 20 4 2 4 Combination with other Devices ss 23 5 SCAN UD PEAR A 25 5 1 Gena MONado a rE EAE ae aa 29 5 2 COA SSSR E E E E E 27 9 3 Positioning of the Patient Rest 28 X31 MEAO FIS PR ee ee ee 28 5 4 Marker FINNO NS ITACTIONS sado see ecran 29 IAT OBS MAKO S a ee 29 IAL FNMA OIS o E 30 CO SIG Mak ceren oE E EEE ate 30 OA TEI UV INO MAKO S eee E EEE 31 6 Localization and Biopsy
6. Incorrect assembly and operator errors made by untrained per sonnel can permanently damage individual parts of optional components and of the device itself In the following the mammographic imaging process with the medio lateral alignment of two fixation and immobilization devices for the simultaneous diagnosis of the left and right breast is described e Insert base plates into the insertion plate coil on the right and left sides in such a way that two immobilization plates with one slat lateral plate each can be used medio laterally on both sides laterally with the curved slat lateral plate supplied also horizontally for possible improved patient comfort NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O du Cc ts 82 Localization and Biopsy Process During the examination some parts of the breast may come into contact with the surface of the base plate with the low probability Before each examination of the patients the base plate must be covered with a clinical cloth e Position the patient on the patient rest and immobilize the breast to be examined by pressing the slat lateral plates on the variable position bars in such a way that the patient can lie as comfortable as possible during the entire examination e Ensure that as much breast tissue as possible is held between the slat lateral plates e Use the toolbox of your MRI system to determine ROI FOV and type of sequence e Perform the MR ma
7. Post amp Pillar Needle Guide auto 111451 clavable and reusable Material PEEK able to be angulated by 15 and 30 Post amp Pillar Marker autoclava 111300 ble and reusable Material PEEK remove marker liquid before auto claving and refill afterwards NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 100 Technical Specification pemon meme Post amp Pillar Needle Guide 111298 Sleeve Set for 18G 16G and 13G autoclavable and reusable Material PEEK also individually acquirable Post amp Pillar Needle Guide 18G 112654 Sleeves for 18G 16G 14G and 16G 112597 12G disposable in sterile packag ing packaging consists of 5 piec 14G 112655 es 12G 112653 Base Unit Fixation Plate can be 111242 used laterally medially and cranio caudally and is used as adapter for the slat plates of the grid reusable disposable and for attaching the positioning system Slat Plate Vertical medial cranio 117145 caudal Slat Plate Vertical lateral only for 117139 NORAS BI320 Slat Plate Horizontal medial 111212 cranio caudal MRI Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 101 Technical Specification pemon meme Slat Plate Horizontal High me 118144 dial cranio caudal for thorax prox imity interventions Slat Plate Horizontal lateral only 111301 for NORAS BI320 9 4 3 Accessories for Grid Biopsy System D meme
8. Grid Method with Grid Biopsy System Height Adjustable lateral medial cc disposable Perform several biopsies or wire placements at various lesions in one step EN disposable reusable The two Grid Biopsy Units Height Adjustable lateral medial cc disposable offer a cost effective alternative for a lateral medial and cranio caudal breast biopsy applica tion The low priced disposable grids reduce autoclavable costs and improves patient throughput The height adjustable design guarantees best access Biopsies and wire placements can be performed by either reusable autoclavable or disposable ster ile grid needle blocks Before use the sterile disposable grids must not come into con tact with unsterile or contaminated components Before using the sterile disposable grid the instructions for use must read in full and with care The sterile packaging and the instruments must be checked for proper condition NORAS mri Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 17 Device Description The sterile disposable grid is for single use only it is not resteri lizable and must be properly disposed after use Only qualified personal should use sterile disposable grid Please always wear protective gloves and carefully comply with the application times for Hepatitis B and HI viruses See the instructions for use of the respective disinfectant solu tion b Modular NORAS Biopsy Units C
9. Pillar Biopsy System for the examination of a single breast NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 33 Localization and Biopsy Process Medial and lateral access Push the fixation plate with the medial slat plate onto the shorter raster bars of the base plate Ref 111292 as far as it goes Slide the second fixation plate with the curved slat plate onto the longer raster bars of the base plate marked Lateral CC up to the stop Insert the base plate into the round pits of the insertion plate of the patient rest After aligning the complete fixation unit in medio lateral direction slide the fixation plate until the end of the raster bars The fixation unit is now open as far as possible For medial access insert the blocking plate into the patient rest of the side of the breast which is not to be biopsied Now position the patient on the patient 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 Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 34 Localization and Biopsy Process Zugang cranial caudal To enable cranial caudal access proceed as described previous to provide medi al lateral access Please note
10. e Detect the marker block and the lesion in the MRI using sagittal slices e Mark the lesion with a permanent auxiliary point from the software toolbox of your MRI system e Copy paste the point into all slices e Go to the outer lateral or medial slice and look for the grid indentation the indenta tion is best viewable when sufficient tissue is placed into the square grid holes e Search for the copied point and the marker block pointer e Replace the marker block into the grid hole where the marked point is viewable NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 19 Localization and Biopsy Process Marker verschieben Marker block to be relocated e After the axial or coronal scan the layer of the lesion and marker block can be veri fied in order to determine the exact puncture hole e In general it is sufficient to be close to the lesion when inserting a localization wire NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 76 Localization and Biopsy Process e When the marker block and the lesion are in the same plane determine the dis tance between the skin and the lesion using your toolbox Abstand Distance NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts T7 Localization and Biopsy Process e Push the needle block with the desired diameter 12G 14G or 18G into the corre sponding opening in the compression
11. ee eee _ o l ee eee oe er a a A a i T gt n EE Dranct Dinnc Datinnt Dact DIRANA DAC Dreast Bio DSY ratlent NEST DIOZU FA I Localization and Biopsy Process 9 Note the slice number of the marker here 21 In this example there is a differ ence of 8 slice thicknesses between marker and lesions With the assumption of 3 mm thickness for each slice and no gap between the slices it results in 8x3mm 24mm offset in head direction B FFEM Drnnet Dinnc Datinnt Dact DIRANA DA DL Dreast Bio DSY ratlent NEST DIOZU FA I Localization and Biopsy Process 10 Move the Post amp Pillar positioning unit with the marker according to the calculated coordinates in our example 16 5 mm downwards anterior and 24 mm towards the head Perform a control scan in order to check that the marker is located in front of the le sion Rraact Binney Datiant Ract RI290N_DA_DU Dreasl Bio DOSY Fratllent Kest DIOZU FA FR 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 33 2 mm Subtract an offset depending on the biopsy system normally about 5 10 mm in order to posi tion the cannula lie in front of the lesion Now puncture the breast with the trocar using this offset corrected depth starting at skin surface Afterwards pull the n
12. 135 kg 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 patient rest to mri noras de or go to www noras de Before examination with patients it is recommended to train on the phantom in order to be familiar with the system The application conditions have a major impact on product life Since these condi tions can vary greatly from user to user an estimate of life time is not possible The most important factors in influencing product life are the frequency of application and processing method cleaning disinfection and sterilization NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 5 General Information 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 Safety Take into account the intended use and specified warnings in the manual as well as performing of visual inspection for all components before using the product on the patient Please follow the safety instructions of MRI manufacturer for operators patients and third parties Prescription use only Country specific laws restrict this device to sale by or on th
13. 6 1 With Post amp Pillar Biopsy System and the operator s manual of your vacuum biopsy gun Please follow the instructions of chapter 6 1 With Post amp Pillar Biopsy System and the operator s manual of your vacuum biopsy gun 6 1 5 Post amp Pillar Adapter 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 auto claved The needle guide sleeves need to be sterilized autoclave method or similar Please see chapter 7 Cleaning Disinfection and Sterilization When using a vacuum gun in combination with our Post amp Pillar adapters the Post amp Pillar marker has to be sterilized according to our sterilization instruction When using a steam autoclave please follow the Post amp Pillar marker instruction for sterile filling It is recommended to perform the adjustment of the coordinates with both the needle guide contained in the set and the inserted Post amp Pillar marker After setting the height adjustment note the adjusted height In order to place the cannula for puncturing exchange the guidance bracket with the inserted Post amp Pillar marker against the sterile adapter without Post amp Pillar marker A control scan the tissue sample can now be taken NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C
14. Air Pressure Min 500 hPa Max 1060 hPa NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 95 Maintenance Storage and Waste Disposal 8 3 Waste Disposal All of the materials used in the manufacture of the system components can be con veniently recycled and therefore do not present any particular or unusual hazards during their disposal Prior to disposal the system must be disinfected as described above to eliminate any risk of infection Following its final use the system should be returned to the manufacturer for dispos al We would be happy to provide you with additional information about disposal upon request NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 96 Technical Specification 9 Technical Specification 9 1 Historical Device Data Designation model type Breast Biopsy Patient Rest BI 320 PA PH Manufacturer NORAS MRI products GmbH Leibnizstrasse 4 97204 Hoechberg Germany Operation type E active x non active Product class Device class per MDD annex IX chapter Ill clause 1 paragraph 1 1 1 4 rules 1 and 4 Identification number of notified body C marking Product type Device type accord ing to UMDNS DIMDI Positioning Aid 16 223 Supplier NORAS MRI products GmbH Leibnizstrasse 4 97204 Hoechberg Germany Test Control time limits type Intended purpose according to in formation provi
15. Grid Markerblock autoclavable 111251 and reusable material PEEK remove marker liquid before auto claving and refill afterwards Grid Needle Block Set for 18G 111299 14G and 12G used for 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 re usable material PEEK NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 102 Technical Specification Description Grid Biopsy Unit Height Adjust 112235 able lateral disposable in sterile Sir ry packaging packaging consists of 5 grids Grid Biopsy Unit Height Adjust 112238 able medial CC disposable in sterile packaging packaging con sists of 5 grids Grid Needle Blocks for 18G 18G 112660 16G 14G and 12G disposable in 16G 112143 sterile packaging packaging con sists of 5 pieces 14G 112659 12G 112731 NORAS mri Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 103 Technical Specification 9 4 4 NORAS Adapter for Vacuum Guns For our biopsy units we offer a large amount of adapters for the traditional vacuum guns Upon request we can also manufacture suitable adapters for your system Your Vacuum System Adapter for Grid System Adapter for Post amp Pil lar System MR10062 VAC a Now FA Suros Surgical ATEC MR100
16. Patient Rest BI320 PA PH may only be used in combination with the above named devices and coil as well as accessories supplied by NORAS MRI products GmbH The use of accessories supplied by other manufacturers is only permitted with the express written approval of NORAS MRI products GmbH 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 mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 24 Start Up 5 Start Up 5 1 General Information Device damage coil error Only trained personnel may be assigned to handle the Breast Biopsy Patient Rest BI320 PA PH Operating errors may cause permanent damages to the de EG vice coil Bodily injuries Only trained personnel may be assigned to handle the Breast Biopsy Patient Rest BI320 PA PH Operating errors may cause bodily injuries e g contusions to the user and or patient Danger of infection Prior to start up of the devices or parts thereof all compo
17. Process ss 32 6 1 VV Post Pillar Biopsy SySle M a no iraco bDross 33 6 1 1 Post amp Pillar Adapter for Ethicon Mammotome MR 63 6 1 2 Application of the Post amp Pillar Adapter for Ethicon Mammotome MR in combination with the Siemens Syngo Biopsy Software 67 6 1 3 Post amp Pillar Adapter for SenoRx EnCor 1 0 0 ccc ccccceeceeeeeeceeeeeeeeeeeeeaeees 70 6 14 Post amp Pillar Adapter for Suros ATEC ir 70 6 1 5 Post amp Pillar Adapter for Bard VaCora cccccccecceeeceeeeeeeeeeeeeeeeneeeeeeneees 70 6 1 6 Multi Purpose Needle Hub Assembly VU 71 Breast Biopsy Patient Rest BI320 PA PH NORAS mr products f 6 2 6 2 1 6 2 2 6 2 3 6 2 4 6 3 6 4 8 1 8 2 8 3 9 1 9 2 9 3 9 4 9 4 1 9 4 2 9 4 3 9 4 4 9 4 5 10 11 Breast Biopsy Patient Rest BI320 PA PH Content A VIET Grd TIO SY SION ee ETE ienee 12 Grid Needle Block Adapter for Ethicon Mammotome MR nsaan 81 Grid Needle Block Adapter for SenoRx EnCor 81 Grid Needle Block Adapter for Suros ATEC M 81 Grid Needle Block Adapter for Bard Vacora 82 SARA OO DA ee 82 SA D MOF MAO a am a uen 84 Cleaning Disinfection and Sterilization 85 Maintenance Storage and Waste Disposal 95 MANGANAN OO seara 95 2 0 ea E E E 95 Vya e DIS
18. been validated by Dr Schwarzkopf vacuum mat tresses Markers must be emptied prior to sterilization NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 92 Cleaning Disinfection and Sterilization Storage Safe dry dust free and protected from light Constant temperature 23 C 2 C Constant humidity below 60 rel humidity Additional In When sterilizing multiple instruments in one autoclave cycle formation ensure that the sterilizers maximum load is not exceeded Manufacturer See chapter 10 Contact Danger of destruction Improper disinfection may result in malfunction of the device Non respect of the disinfection instructions may cause the de struction of the device No warranty service will be provided for damages due to improper disinfection Danger of infection The disinfection instructions must be followed In case of inadequate disinfection the risks of infection arise to G04 G19 user and or end user NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 93 Cleaning Disinfection and Sterilization Danger of destruction Improper sterilization may result in malfunction of the device Non respect of the sterilization instructions may cause the de struction of the device No warranty service will be provided for damages due to improper sterilization Danger of infection The sterilization instructions must be followed In case o
19. plate and using the toolbox determine the desired penetration point on the needle block e Select the needle block with the proper size needle and mount these in the calcu lated position Select a needle with an appropriate length to reach the lesion Con sider to add the offset an approximately 25 mm to the distance skin lesion Insert the needle to a position approx 10 mm in front of the lesion e If possible needle diameter to be considered set a local anesthesia using the block slot that has been determined Remove the needle block and apply an addi tional anesthesia if necessary This may be done using a bigger needle by slightly cutting the tissue with a sterile scalpel Especially with lesions close to the surface this might be very important to avoid a delocalization NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 78 Localization and Biopsy Process e When replacing the needle block place the cannula and remove the trocar After the control scan the wiring or removing of tissue may be performed Please make sure no artifact is notable when using plastic cannulas and removing the trocar Having removed the trocar close the cannula using the provided equipment sterile plastic stick This prevents blood from entering the cannula e Perform a control scan with the inserted needle Set the distance shown in the toolbox between the needle point and the lesion on your needle scale and pene trate with t
20. use of the compression plates and needle blocks Biopsy access is single sided medial single sided double sided lat eral or single sided double sided cranio caudal 3 1 Safety Concept The following safety concept must be strictly followed while performing a biopsy control scan must be made after each work step to verify the correct completion of the previous work steps to be able to recognize incorrect adjustments of the needle guides bases and needle blocks during the biopsy That is the only way to recognize incorrect adjustments incorrectly read scale values and other operator errors in order to prevent injuries to the patient The control scan procedure is described in Chapter 6 Localization and Biopsy Pro cess and the correct result illustrated in the text Breast Biopsy Patient Rest Version 2 MR10320 PH 2 for Philips Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 9 Device Description 4 Device Description 4 1 Definitions and Symbols The following symbols are used on the Breast Biopsy Patient Rest BI320 PA PH and in this operator s manual ISO 7000 2497 Date of Manufacture EN ISO 7000 1641 Operator s Manual ISO 7000 0434B Caution read the accompanying documents Waste products should not be disposed of with household waste e g at a local authority collection point DIN 55402 T i ISO 7000 2498 serial Number DIN EN 980 5 10 Item Number NORAS mrr Directive 2002 96 EC
21. wall ob vious lesions you can heighten the coil upper part using Philips foam aids and press it to the body NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 21 Device Description Pull back the four guide rods arrows A in the diagram and place the four pressure plates arrows C in the fig ure by gently pressing on click Check whether the bolts and the in tended openings are clashed While setting of the pressure plates arrows C in the figure make sure that the high side of the slope directs to outside lateral and the deepening of the slope directs to inside medial so that the plates may be presented in V shaped to the patient and in the center shows no heightening 4 2 3 3 Handling of the Cranio caudal Fixation Unit Fix the breast using two guide rods arrows A in the figure Firstly push the pressure plate toward the chest and press it lightly by a rod arrow C in the figure then fix the plate using the screw arrow B in the figure The screw can be screwed in from the side or from above Slide the second rod slide together with pressure plate toward the chest until the desired setting is reached Now fix it using the second screw arrow B in the figure MRI Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 22 Device Description 4 2 3 4 After mounting the Cranio caudal Fixation Unit After fixing both breasts drive the table to light visor and
22. 61 AT MR10062 AT R R SenoRx EnCor 10G MR10061 SE 10G MR10062 SE 7G on request 7G 113315 a C R Bard Vacora MR10061 VAC Ethicon Mammotome MR10061 ET MR10062 ET2 C s SP10062 ET for Siemens Aiming Device NORAS mri Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 104 Technical Specification Suitable for all NORAS Post amp Pillar Biopsy Units Guidance Bracket PEEK for Invivo Disposable Needle Guidance Disposable Needle Guidance 113692 Multi Hub Assembly not for 7G MR10062 MHA 9 4 5 General Dm Mian Blocking Plate 111319 A blocking plate to raise the alter D nate breast is required for medial biopsies Operator s Manual BI320 PA PH 118309 Bodily injuries due to accessories When using accessories please always observe the manufactur er s instructions NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 105 Important Addresses 10 Important Addresses Manufacturer product development and production NORAS MRI products GmbH Leibnizstrasse 4 97204 Hoechberg products Germany Telephone 49 931 2 99 27 0 Telefax 49 931 2 99 27 20 E Mail mri noras de Internet www noras de NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 106 Operator Training Outline 11 Operator Training Outline have reviewed the Breast Biopsy Patient Rest BI 320 PA PH Training Outline and unders
23. DOSA de ee ee EEEE EEEE 96 Technical SDECHICATION 22 annee na nee entente 97 Historical Device Data 97 PO AR a O 98 POS E E E E 99 Options and Accessories wisnsanisnndensscevianenswsuaensasetasannediaenssandenennntdanssnodaaensssie 100 Compilation of the Biopsy System cccccccceccseeeeeeeeeeceeeeeeeseeeseeeseeeaees 100 Accessories for Post amp Pillar Biopsy System cccceccseeeeeeeeeeeeeeeeeeaes 100 Accessories for Grid Biopsy System 102 NORAS Adapter for Vacuum Guns 104 CCE ET T E EE A ENET ETETE E EET 105 IMPORANTATOFESSSS na a en ses un 106 Operator Training Outline ins snrrsnrrrnrrnsrsrnns 107 NORAS mr products General Information 1 General Information A prerequisite for safe and trouble free operation is the proper observance of instruc tions in particular the following points The diagnostic imaging is enabled by Philips 4 Channel SENSE Body Coil that can be integrated with foam wedges into the patient support For biopsy the Philips Cir cular Coil C1 can be used with the biopsy system and in connection with the body coil in MRI and the Patient Rest MR10320 PH 2 with the Immobilization and Biopsy System The Philips patient rest is designed for a permissible maximum patient weight of up to 135 kg The Philips patient rest meets the requirements of the DIN EN ISO 60601 2 46 Maximum allowed patient weight The maximum permissible patient weight may not be exceeded of
24. acuum system manufacturer was read and understood The NORAS Mammotome MR Adapter is compatible with the Ethicon Holder for the reception of the Ethicon Mammotome MR Universal Targeting Sets MRU11S MRU11X MRUO8S and MRUO8X Danjer of injury and delocalization The NORAS Mammotome MR Adapter is the guidance and positioning of the Targeting Set as well as the vacuum system In addition it can carry the Targeting Set individually into the con trol scan The NORAS Mammotome MR Adapter is not capable of carrying the weight of the vacuum system individually During the control scan the Mammotome Targeting Set must not slip NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 66 Localization and Biopsy Process 6 1 2 Application of the Post amp Pillar Adapter for Ethicon Mammotome MR in combination with the Siemens Syngo Biopsy Software In order to identify the coordinates with the Siemens Syngo Biopsie Software the MR10017 ET 10 block marker is required see iil Special designed marker MR10017 ET 10 for application in combination with Siemens Syngo Software Marker 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 un til it locks in After that the fiducial holder can be placed on one of the guide bars With the use of the Siemens Syngo Biopsy Software the block ma
25. align the laser sight on the center of the coil After retracting the patient the examination can be begun 4 2 4 Combination with other Devices The diagnostic imaging is enabled by Philips 4 Channel SENSE Body Coil that can be integrated with foam wedges into the patient support For biopsy the Philips Cir cular Coil C1 can be used with the biopsy system and in connection with the body coil in MRI and the Patient Rest MR10320 PH 2 with the Immobilization and Biopsy System Special NORAS adapters are available for the use with Bard Vacora Suros ATEC and SenoRx EnCor biopsy systems The respective adapters for the grid system must simply be inserted in the desired position of the grid Be sure that the adapters are firmly seated With the help of the MRI software you can determine the correct gauge hole through which the needle must be guided The Post amp Pillar adapters are attached to the guide base and can thus serve as a needle guide The adapters are indicated in Chapter 9 4 Options and Accessories NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 23 Device Description The Mammotome MR Biopsy System from Ethicon Endo Surgery Inc FDA K042753 can be used with a special adaptor For more information see Chapter 6 Localization and Biopsy Process Upon request suitable adapters for your system can be manufactured Combination with other devices The Breast Biopsy
26. ant to perform the biopsy in our examples e g a 0 b 30 for a a horizontal adjustment b towards nipple adjustment 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 Data 0407 2009 17 27 50 Patent Mm nreotob effy edecter horas Date of Birth 0101 1970 Date 0997 2009 17 2642 Vertical Move A5 3 on towards nipple Dept 6 5 cm Series Name Biopsy Leson _1 Seres Name Biopsy 30 Lesion 1 Background In this way the Siemens Syngo Biopsie Software is informed that the center of rota tion of the NORAS Mammotome MR Adapter varies from the standard NORAS po sitioning unit The center is located 68 mm not the usual 22 mm behind the tip of the pointer which is visible in the MR image Please consider this when you determi nate the insertion depth For selecting and instruction information about the specific Targeting Set please look at the manual of your vacuum system manufacturer NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 69 Localization and Biopsy Process 6 1 3 Post amp Pillar Adapter for SenoRx EnCor Please follow the instructions of chapter 6 1 With Post amp Pillar Biopsy System and the operator s manual of your vacuum biopsy gun 6 1 4 Post amp Pillar Adapter for Suros ATEC sail Please follow the instructions of chapter
27. ded by the manufac turer The device is intended for use during the MRI examination of the female breast Biopsies can also be made with the system Serial number NORAS mr Breast Biopsy Patient Rest BI320 PA PH products 97 Technical Specification 9 2 Performance Data Operating temperature Corresponding with the air conditioned room temperature of the MRI room Storage temperature Room temperature Weight 13 5 kg Dimensions 740 x 460 x 180 mm Interfaces Electrical Philips MRT Mechanical MRT Patient Rest NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 98 Technical Specification 9 3 Parts List Patient Rest MR1031 1 Version 1 Patient Rest Version 2 Wedge Cushion 118310 Noras Head Rest Breast 112300 Pad Cushion 112317 MRI Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 99 Technical Specification 9 4 Options and Accessories 9 4 1 Compilation of the Biopsy System CC Matton Ro Base Unit for all NORAS BI320 112663 Biopsy Systems Post amp Pillar Biopsy System 111449 lateral medial cranio caudal k Grid Biopsy System lateral me 111456 dial cranio caudal Grid Biopsy System Height Ad 112658 justable lateral 335 9 4 2 Accessories for Post amp Pillar Biopsy System Dep meme ne Post amp Pillar Positioning Unit 111259 with Telescope Bar autoclavable i and reusable Material PEEK
28. distance tool again and measure the distance between the lesion and the reference line that you copied in step 4 Please note these measurements on a separate piece of paper In this example the Post amp Pillar positioning unit has to be moved 16 5 mm from the marker zero position to anterior because the patient is lying in the prone position f de ira Wig VW H er HO m re 40 ir Ay 4 4 i 5 gt x i Bee amp Rras Rinne Rea R1320 PA Breast Biopsy Patien BI320 PA gt gt Lissabon VCG Resp 5s Localization and Biopsy Process 7 Now the number of slices between marker and lesion are counted For this pur pose change the sequence in the Review Planscan mode PHILIPS Patient System Help 18 50 SE 2 Ea Ussabon gt 12 01 01 2008 123777 0 Transversal FOV 220 10 TSE M 23 05 2011 18 19 Slice 29 45 Basic Viewing Review Planscan ro 388 System Ready 45 HC Screen HCCase Compose Compose ni v Hardcopy preview HH H Scan 9 j More All eranc 2 MNNC L east DIODS L View Window RAL No sensor s detected rauent Res Localization and Biopsy Process 8 At the top of the image you see the spatial orientation of the slices here 45 slices which have been numbered increasing from foot towards head Note the slice num ber in which the lesion is located here 29 Sc3 B FFE M S17
29. e or der of a physician or with the descriptive designation of any oth er practitioner licensed by the law of the country in which he practices to use or order the use of the device This device may only be distributed to persons who are licensed practitioners or to persons who have a prescription or other order from a licensed practitioner to purchase it NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du Cc ts 6 Intended Use Indication for Use 2 Intended Use Indication for Use The intended use of the Breast Biopsy Patient Rest BI320 PA PH is in conjunction with a Magnetic Resonance Scanner the MR examination of the female breast It is indicated for use in combination with the Philips coils as a diagnostic imaging device to produce transverse sagittal coronal and oblique images of the internal structures of the female breast When interpreted by a trained physician these imag es provide information that can be useful in determining diagnosis The Biopsy Unit permits MR guided breast biopsy and wire localization of lesions can be performed by a trained physician Pad Cushion112317 Head Rest Breast 112300 Philips 4 Channel SENSE Body Coil Patient Rest MR10320 PH 2 Biopsy Unit NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 7 Intended Use Indication for Use 2 1 Indications e Tumor recognition in the case of unclear diagnoses from other diagnostic pro cedure
30. eedle 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 Drnnet Binnc Datinnt Dact BI290N_ DA DUO Dreast B IOPSV Fatient Kest DIOZU FA I l Localization and Biopsy Process 12 Perform a control scan in order to check that the end of the needle is positioned in front of the lesion 16 TUFTNEF DIO May el C LA Th i I a Fe UE A EST ll he ne i i A O _ fi l AR ne fi a A ead a iQ H A y D 4 y i 6 g j p a 5 17 4 gA reid tral LT DE AA Hi Localization and Biopsy Process Control scan shows large or no image distortion Please pay attention to removing the metal trocar when inserting the cannula When using a plastic cannula the metal trocar has to be replaced by the provided plastic stick Needle penetration at incorrect location Please take care of using a needle with the appropriate size gauge as well as the corresponding needle guide sleeve In case of extreme small needle sizes the lesion may be missed In case of extreme large needle sizes there is a risk of damage to the needle Insufficient penetration depth Please take care of using a needle with the appropriate length 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 comp
31. ergent solution to all surfaces ensuring that hinged components are cleaned in both open and closed positions 3 The part is held under running water for 5 minutes In this case the running water must flow through the cannulas The blind holes must be repeatedly filled and emptied 4 The parts must be cleaned as long as no visible blood or tissue residues more on the products to be seen For manual disinfection it is advisa ble to insert the parts for expected parts see left column in the solution immediately after use Ensure that the parts are completely submerged in the solution Take the parts from the solution after the described time NORAS mrr Breast Biopsy Patient Rest BI320 PA PH products Applicable only for Biopsy Set consists of Base Plate Fixation Plate lateral medial Slate Plate vertical amp horizontal Curved Slate Plate vertical amp horizontal Post amp Pil lar Positioning Unit Post amp Pillar Marker Needle Guide Sleeve Set Grid Localization Needle Block Set Grid Markerblock Blocking Plate Autoclave Box Needle Guide Post und Pillar Adapter for Ethi con SenoRx ATEC Vacora Grid Needle Block Adapter for Ethicon SenoRx ATECTM Vacora 89 Cleaning Disinfection and Sterilization 15 minutes and rinse by water the quality of water must be at least equal to drinking water better would be using aqua Demineralized wa ter Cha
32. f inadequate sterilization the risks of infection arise to G05 C20 user and or end user NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 94 Maintenance Storage and Waste Disposal 8 Maintenance Storage and Waste Disposal 8 1 Maintenance Prior to each use all components of the Breast Biopsy Patient Rest BI320 PA PH must be visually inspected and controlled for breakage cracks and wear off Patient Rest Check for breaks or cracks Immobilization and Fixation Unit Check for breaks or cracks 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 regard ing the test performance and its results must be recorded in the medical devices log book 8 2 Storage Following its use and the required cleaning disinfection and Sterilization the device should be stored at room tempera ture in a dust free UV radiation protected location min 10 C max 30 C In the case of re sterilized needle guide sleeves you must not exceed the maximum storage period currently 6 months if stored in single or double packaging in protected storage in dust tight containers cabinets drawers or similar places e Relative Humidity Min 10 Max 95 e
33. f the distally deformed needle end with a suitable MR compatible tool and remove the remaining trocar Retraction of the needle with the bent end section would injure the breast Danger of bruising Be absolutely sure to loosen the slat lateral plates before with drawing the breast That way bruises or injuries to the patient can be avoided Danger of injury Before loosening and withdrawing the breast you must remove all instruments If all instruments are not removed you may injure the breast of the patient NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 62 Localization and Biopsy Process 6 1 1 Post amp Pillar Adapter for Ethicon Mammotome MR In application with the Ethicon Mammotome MR Vacuum System we offer a modi fied positioning device with similar functions as the standard version In order to sup port the doctor with the stabilization of the Mammotome holster the modified unit is larger Two different sized guide bars replace the telescope bar Please also regard Ethicon directions when using this device lateral guide bar A cranio caudal guide bar Sdi The needle guide girder with mounted pointer has to be inserted in the right lateral splint of the fiducial holder until it locks in After that the fiducial holder can be placed on one of the guide bars lateral cranio caudal height and angle adjustment screw S r a Guide Plate a a s Guide Ba
34. fixated Height angle adjustment screw ee il MR Targeting Set Ethicon Guide fork Ethicon Clamping screw Targeting Set Ethicon MRI Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 64 Localization and Biopsy Process In case of a very anterior lesion position the guide fork Ethicon can be set on a higher position which enables another 17 mm anterior access Please note that in this procedure the holster must be held upside down so that tissue samples will fall downwards Vertical and horizontal Lowest adjustable 0 position of the pointer position of the pointer After adjustment of the calculated coordinates please perform a control scan with installed Ethicon guide fork The scan shows the pointer as a light line which points towards the 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 Set please look at the manual of your vacuum system manufacturer Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 65 Localization and Biopsy Process Bodily injuries due to accessories The NORAS Mammotome MR Adapter may only be used if the operator s manual of the v
35. he needle to the lesion Perform the biopsy in accordance with the instructions of your needle and or vacuum manufacturer Control scan shows large or no image distortion Please pay attention to removing the metal trocar when inserting the cannula When using a plastic cannula the metal trocar has to be replaced by the provided plastic stick Needle penetration at incorrect location Please take care of using a needle with the appropriate size gauge as well as the corresponding needle guide sleeve In case of extreme small needle sizes the lesion may be missed In case of extreme large needle sizes there is a risk of damage to the needle Insufficient penetration depth Please take care of using a needle with the appropriate length Using a too short needle you might not reach the lesion NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 79 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 i
36. he system No warranty service will be provided for dam ages due to improper disinfecting Please always wear protective gloves and carefully comply with the application times for Hepatitis B and HI viruses See the instructions for use of the respective disinfectant solution Limitations on re Frequent processing can have an impact on these prod processing ucts color changes but do not affect the function of the product Frequent processing can have an impact on these products col or changes but do not affect the function of the product Please always wear protective gloves and comply with the appli cation times for Hepatitis B and HI viruses See the instructions for use of the respective disinfectant solution NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 85 Cleaning Disinfection and Sterilization INSTRUCTIONS Point of Use Remove excess soil with disposable cloth paper wipe Storage and No particular requirements It is recommended to perform the Transport processing of the product as soon as possible after its use The products must be transported in a closed container Preparation for No particular requirements If necessary the assembly must Cleaning be disassembled into its individual components Needle blocks and needle guide sleeves could possibly be pre cleaned by syringe or water nozzle Cannulas and holes must be connected in accordance to rinse body Pay attent
37. ion to correct flow Preparation with H202 or enzymatic cleaner could be done NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 86 Cleaning Disinfection and Sterilization Cleanin auto mated All parts can be cleaned by ma chine the excep tion cases are coil cables and plugs patient rests patient pad coils PPC insertion plate coils IPC cushions head cushions vacuum mattress es Equipment Washer disinfector Detergent Example alkaline deter gent such as Neodisher MediCle an forte 0 2 1 0 vol 2 10 ml l Dr Weigert at 50 C For this pur pose all agents which have been approved and released by the Robert Koch Institute RKI can be used in accordance with the instructions on their labels Procedure 1 Load components such that hing es are open and cannulations and holes can drain For needle blocks and needle guides a pre cleaning by means of syringe or water jet may be necessary 2 Run cycle minimum 5 minutes clean and 5 minutes rinse 3 When unloading check cannula tions holes etc for complete remov al of visible soil If necessary repeat cycle or use manual cleaning NORAS mr Breast Biopsy Patient Rest BI320 PA PH products Applicable only for Biopsy Set consists of Base Plate Fixation Plate lateral medial Slate Plate vertical amp horizontal Curved Slate Plate vertical amp horizo
38. letion of the biopsy clean the device parts as described in chapter 7 Cleaning Disinfection and Sterilization NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 50 Localization and Biopsy Process Danger of penetration through the breast Should under exceptional circumstances the needle be bent while in the breast e g if the needle should strike one of the three horizontal slats after penetrating through the breast 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 injure the breast Danger of bruising Be absolutely sure to loosen the slat lateral plates before with drawing the breast That way bruises or injuries to the patient can be avoided Danger of injury Before loosening and withdrawing the breast you must remove all instruments If all instruments are not removed you may injure the breast of the patient NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 51 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 Philips MR systems Perform the steps 1 to 10 from the user manual for the straight manual calculation of coordinates If you notice during the straight biopsy that for example one of the bars of the grid is in
39. lices is next described This applies for the use of the system with the grid for the examination of a single breast In the case of the simultaneous biopsy of both breasts lateral access use a second fixation unit and a second grid on the other side and proceed in the same way NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 72 Localization and Biopsy Process Medial and lateral access Push the fixation plate with the disposable medial grid plate onto the shorter raster bars of the base plate Ref 111292 as far as it goes Slide the second fixation plate with the disposable lateral grid onto the longer raster bars of the base plate marked Lateral CC up to the stop Insert the base plate into the round pits of the insertion plate in the patient rest After aligning the complete fixation unit in medio lateral direction slide the fixation plate until the end of the raster bars The fixation unit is now open as far as possible For medial access insert the blocking plate into the patient rest of the side of the breast which is not to be biopsied Now position the patient on the patient rest and immobilize the 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
40. mmographic procedure Danger of bruising Be absolutely sure to loosen the slat lateral plates before with drawing the breast To do so simultaneously push the left and right slides and pull the lateral slat plate outwards That way bruises or injuries to the patient can be avoided NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 83 Localization and Biopsy Process 6 4 Safety Information Please consider the following when using the Breast Biopsy Patient Rest BI320 Permanent damage to the system The system may only be assembled by trained medical person PA PH nel Incorrect assembly and operator errors made by untrained per sonnel can permanently damage individual parts of optional components and of the device itself In 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 r pe SS wy praa NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 84 Cleaning Disinfection and Sterilization 7 Cleaning Disinfection and Sterilization WARNING The procedure must be followed as described In case of inadequate cleaning disinfection or sterilization you carry the risk of infection Non compliance with the cleaning instructions may destroy t
41. mrr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 73 Localization and Biopsy Process Cranial caudal access Slide the fixation plate with the medial slat plate re usable or with a second dispos able medial grid onto the shorter raster bars of the base plate Ref 111292 as far as it goes Slide the second fixation plate with a disposable medial grid onto the longer raster bars of the base plate marked Lateral CC up to the stop Proceed as de scribed above access medial and lateral Please note that when the biopsy device is turned into the cranio caudal direction the MRI images must be made in the axial or transversal direction to correspond with the following description During the examination some parts of the breast may come into contact with the surface of the base plate with the low probability Before each examination of the patients the base plate must be covered with a clinical cloth Needle penetration at incorrect location The breast must be correctly immobilized If the breast is not immobilized properly it might slip and the data delivered by the MRI might be inaccurate e Ensure that as much breast tissue as possible is held between the medial slat plate and the lateral grid e Insert the marker block supplied into the grid fixation plate NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 74 Localization and Biopsy Process Medial Lateral Anterior
42. nents must be treated as described in chapter 7 Cleaning Disinfection and Sterilization Non compliance with the above instructions may lead to infection of the patient Permanent damage to the system The user has to be trained prior to start up of the device NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 25 Start Up Bodily injuries The user bears the responsibility for using other medical devices 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 Assemble the desired configuration of the biopsy device While pushing it onto the fixation plate be sure the positioning system is pushed on as far as it will go You can check this by listening for an audible click Insert the biopsy device into the insertion opening p
43. nging in color due to con tinuous disinfection cannot be ex cluded but can be largely prevented by sufficient rinsing after each use The solution is distributed on the surfaces by a fluff free cloth The disinfectant permeates the dirt parti cles and because of mechanical forces pressure abrasion this en sures effective cleaning Additional ly the wiping motion ensures that spores which are resistant to the disinfectant will be removed The cloth must be replaced after the dis infection in order to prevent the spreading of the spores on other areas Moreover it is essential that the wiping solution is renewed regu larly daily NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 90 Cleaning Disinfection and Sterilization When drying is achieved as part of washer disinfector cycle do not exceed 50 C Maintenance Inspec Blunt or damaged parts should be discarded Hinged tion and Function Test parts Check for smooth movement of hinge without ex ing cessive play Locking ratchet mechanism should be checked for action All parts Visually inspect for damage and wear Cutting edges should be free of nicks and present a continuous edge Check components with long slender features particularly rotating components for distortion Where components form part of a larger assembly check assembly with associated components Singly A standard packaging material may be used Ensu
44. njure the breast Danger of bruising Be absolutely sure to loosen the slat lateral plates before with drawing the breast That way bruises or injuries to the patient can be avoided Danger of injury Before loosening and withdrawing the breast you must remove all instruments If all instruments are not removed you may injure the breast of the patient NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 80 Localization and Biopsy Process 6 2 1 Grid Needle Block Adapter for Ethicon Mammotome MR APR For use with the Ethicon Mammotome MR the NORAS company offers reusable needle block adapters made of PEEK These ensure the compatibility of the Mammo tome MR Universal Targeting Sets MRU11S MRU11X MRUO8S and MRUO8X with the NORAS grids The positioning process is described in chapter 6 2 After the successful positioning process of the needle block adapter and the control scan please follow the Mammotome MR manual from Ethicon in order to accomplish the biopsy procedure 6 2 2 Grid Needle Block Adapter for SenoRx EnCor aai For use with the SenoRx EnCor Mammo Biopsy System the NORAS company of fers reusable needle block adapters made of PEEK These ensure the compatibility of the SenoRx EnCor Biopsy System EnCor cannulas and probes with 7G 10G and 12G with the NORAS grids The positioning process is described in chapter 6 2 After the successful positioning process of the needle block ada
45. ntal Post amp Pil lar Positioning Unit Post amp Pillar Marker Needle Guide Sleeve Set Grid Localization Needle Block Set Grid Markerblock Blocking Plate Autoclave Box Needle Guide Post und Pillar Adapter for Ethi con SenoRx ATEC Vacora Grid Needle Block Adapter for Ethicon SenoRx ATECTM Vacora 87 Cleaning Disinfection and Sterilization Disinfection tomated All parts can be dis infected by ma chine the excep tion cases are au coil cables and plugs patient rests patient pad coils PPC insertion plate coils IPC cushions head cushions vacuum mattress es Disinfectant Depending on RDG and Vario TD program you can select on disinfectant which has been approved and released for automated disinfection Procedure lf automated disinfection is em ployed a final rinse at 90 C for 5 minutes may be used to effect ther mal disinfection The parts such as needle guides and needle blocks can be disinfected in accordance with the same procedure in an_ ultrasonic bath The assembly must be disassembled into its individual components so that an optimal disinfection is guar anteed NORAS mr Breast Biopsy Patient Rest BI320 PA PH products Applicable only for Biopsy Set consists of Base Plate Fixation Plate lateral medial Slate Plate vertical amp horizontal Curved Slate Plate vertical amp hori
46. ompatible with all NORAS 4 Channel Breast Coils and NORAS Patient Rests BI320 PA Usable for immobilization and MR guided biopsy Our biopsy system consists of superior plastics PEEK and can be used for all tradi tional sterilization processes autoclavable One has the option to purchase dispos able grids for medial lateral and cranio caudal use for the height adjustable grid units The functional unit can be build cost effectively and can be extended based upon request NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 18 Device Description Application Examples Modular set up To fixate the breast several of height adjustable horizontal and vertical slat plates can be used as well as a medical disposable grid or the reusable grid To perform biopsies one can choose from the Post amp Pillar or Grid Method Post amp Pillar Biopsy System lateral with one lateral horizontal slat plate and one medial horizontal slat plate to fixate the breast Post amp Pillar Biopsy System medial or cranio caudal with two medial horizontal slat plates to fixate the breast Grid Biopsy System lateral with height adjustable lat eral grid and medial horizontal slat plate to fixate the breast Grid Biopsy System lateral medial or cranio caudal with grid and medial horizontal slat plate to fixate the breast Grid Biopsy System lateral with disposable lateral grid and medial horizontal slat plate to fixate the brea
47. pper part and a lower part The upper part whose surface is made of fiberglass which will be provided with a two component coating the lower part is made of Seaproof During the examination some parts of the breast may come into contact with the surface of the base plate with the low probability Before each examination of the patients the base plate must be covered with a clinical cloth NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 13 Device Description 4 2 1 3 Cushions Pad Cushion Wedge Pillow Noras Head Rest Breast 112317 118310 112300 4 2 2 NORAS Biopsy Kit Modular Throughout our modular system you can assemble your biopsy units according to your preferences a What is your preferred Biopsy Method Post amp Pillar with Post amp Pillar Biopsy System lateral medial cranio caudal Higher accuracy compared to grid biopsy Angulation is possible SS LLL disposable reusable With our Post amp Pillar System lateral medial cc you can perform exact biopsies The needle sleeve is adjustable by 15 or 30 towards posterior or anterior Biopsies can be performed using either reusable autoclavable or disposable sterile Post amp Pillar needle guide sleeves Various height adjustable horizontal and vertical slat plates can be used to fixate the breast NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 14 Device Description Grid Method wi
48. pter and the control scan please follow the SenoRx EnCor Biopsy System manual in order to accom plish the biopsy procedure ds 6 2 3 Grid Needle Block Adapter for Suros ATEC E For use with the Suros ATEC Biopsy System the NORAS company offers reusable needle block adapters made of PEEK These ensure the compatibility of the Suros ATEC Biopsy System cannulas and probes with 9G with the NORAS grids The positioning process is described in chapter 6 2 After the successful positioning pro cess of the needle block adapter and the control scan please follow the Suros ATEC Biopsy System manual in order to accomplish the biopsy procedure NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O d u C ts 81 Localization and Biopsy Process os LT For use with the Bard Vacora Vacuum Biopsy System the NORAS company offers reusable needle block adapters made of PEEK These ensure the compatibility of the Bard Vacora Vacuum Biopsy System cannulas and probes with 10G with the NORAS grids The positioning process is described in chapter 6 2 After the success ful positioning process of the needle block adapter and the control scan please fol low the Bard Vacora Vacuum Biopsy System manual in order to accomplish the biopsy procedure 6 2 4 Grid Needle Block Adapter for Bard Vacora 6 3 MR Mammography Permanent damage to the system The system may only be assembled by trained medical person nel
49. r Fiducia Holder Needle Guide Girder Pointer Guide Fork Ethicon Right Immobilization Plate scaled Guide Rail 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 mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 63 Localization and Biopsy Process The modified positioning device is now installed and 0 based In order to extract markers and coordinates please follow chapter instructions For horizontal biopsies no angulations 0 the handling of the NORAS Mammo tome MR Adapter is equal to the standard NORAS positioning devices For angu lated 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 be hind 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 as well as posterior angulations are possi ble for 15 and 30 After the angulations adjustment close the adjustment screw slowly until the new position of the fiducial holder is
50. re that the pack is large enough to contain the in strument without stressing the seals In sets The parts may be loaded into dedicated instru ment trays or general purpose sterilization trays Ensure that cutting edges are protected and do not exceed the maximum loading per tray Wrap the trays using appro priate method See also guidance of DGSV RKI and DIN EN ISO 11607 1 NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 91 Cleaning Disinfection and Sterilization Sterilization Steam sterilization The following Only the following items may be subjected to steam steriliza parts may be tion Sterilized neither on basis of STERRAD not Base Plate Fixation Plate lateral medial Slate Plate vertical steam steriliza amp horizontal Curved Slate Plate vertical amp horizontal Post amp tion Pillar Positioning Unit Post amp Pillar Marker Needle Guide Sleeve Set Grid Localization Needle Block Set Grid Marker block Blocking Plate Autoclave Box Needle Guide Post und plugs Pillar Adapter for Ethicon SenoRx ATEC Vacora Grid patient rests Needle Block Adapter for Ethicon SenoRx ATEC Va cora Biopsy Set consists of coil cables and patient pad coils PPC insertion plate Procedure coils IPC 134 C 3 04 bar 5 min cushions The effectiveness of steam sterilization according to the proce head cushions dure mentioned above has
51. rker 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 0 position The vertical O position is indicated by the upper edge of the fiducial holder and the 0 base at the guide bar For height adjustments anterior posterior please adjust the fiducial holder at the requested position and close the adjustment screw see ill above NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 67 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 ll 1 green cross Stere Marker Position f Store LesionPosition To register the lesion click on the target point for the biopsy as usual and confirm the reference point with Store Lesion Position II 2 NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 68 Localization and Biopsy Process Then select the angle with which you w
52. rovided Ensure that the device is firmly seated Only use sterilized needle guides or needle blocks NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 26 Start Up 5 2 Coil Assembly Assemble your Philips coil as presented in the pictures below depending on whether it is for diagnostic or for biopsy Diagnosis Biopsy Similar to the illustration NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 27 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 illustra tion on the left Plug Position the system at the desired location and place the wedge cushion on the MRI table in such a way that the cable lie in the cable guide of the cushion Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 28 Start Up 5 4 Marker Filling Instructions The product is delivered with unfilled markers The number of markers required de pends upon the individual type of system used One marker is needed for manual localization up to four markers are needed for software supported localization Please pay attention to the following marker refilling instructions 5 4 1 Opening Markers Open the Post amp Pillar Marker the Grid Marker Block or the Bolt Marker by hand To open the marker cover in the grid use a screwdriver with a blade width of 8 6 mm and to open the cover of the car
53. s using contrast agents and their decay times e Breast biopsy i e biopsy from lateral medial and cranio caudal direction 22 Contraindication All patient examinations are contraindicated with this system which is also contraindi cated in the proximity of the MRI device according to the information provided by the manufacturer Furthermore the responsibility lies with the examination physician in case of unclear or critical clinical picture Please follow the safety instructions of MRI manufacturer for operators patients and third parties NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du Cc ts 8 Function 3 Function The Breast Biopsy Patient Rest BI320 PA PH consists of a Patient Rest with Im mobilization and Biopsy System Imaging is performed either with a 4 Channel SENSE Body Coil for diagnostic or with Philips Circular C1 Coil in combination with the Body Coil for biopsies 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 operators manual access by the user The Immobilization Device can be rotated by 360 This ensures optimum access to the lesion ca 270 For guidance a telescopic assembly the Post amp Pillar System provides access also to regions very close to the chest wall Axilla An additional access possibility is offered by the alternative
54. st Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 19 Device Description 4 2 3 Accessory Cranio caudal Fixation Unit for Breast Biopsy Patient Rest BI320 PA PH Ref 111905 The Philips Patient Rest MR10320 PH 2 is used for diagnostic imaging and biopsy of the breast Use for diagnostic imaging the original Philips 4 Channel SENSE Body Coil 4 2 3 1 Cranio caudal Fixation Unit In order to perform a faster examination we of fer our CC Fixation In case of a larger chest the field of view can be reduced by half due to re ducing of the scan time up to 50 In addition distracting movements and vibrations of the breast can be avoided Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 20 Device Description 4 2 3 2 Mounting of the Cranio caudal Fixation Unit in the Patient Rest One half of the 4 Channel SENSE Body Coil is inserted in the CC Fixation Unit from below By folding the movable support you can facilitate the insertion and you can bring the coil in the correct position see picture The upper part is then placed from above Now the CC Fixation Unit is sandwiched between the two coils of the 4 Channel SENSE Body Coil The whole system is pushed into the Patient Rest MR10320 PH 2 laterally The upper part of the original Philips 4 Channel SENSE Body Coil is connected to the under side of the Patient Rest using the existing Velcro straps at the coil For chest with chest
55. t rest a damage of the screws could not be excluded When using the grid as a medial application the fixation screws must not be mount ed The screws are only necessary as additional fixation of the grid for the lateral ap plication The medial grid is always mounted in the lowest possible position It is suf ficiently fixated with the ball catch The fixation screws are part of the standard delivery of the basic unit fixation plate The basic unit fixation plate can be used both lateral and medial Using the grid in lateral position it can be moved in 10mm steps up to max 30 mm in posterior direc tion Only with this application the screws are necessary for a safe fixation NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O du Cc ts 32 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 person nel Incorrect assembly and operator errors made by untrained per sonnel can permanently damage individual parts of optional components and of the device itself Training of personnel The users must be trained before using the device detailed training of the personnel for existing components In the following the localization process with medio lateral alignment of the fixation unit lateral access and the use of axial slices is described The description applies for the use of the system with the Post amp
56. tand the topics discussed and verify that the training outlined is complete The training delivered was reflective of the details in the Breast Biopsy Patient Rest BI320 PA PH user manual will read or have read this appropriate manual includ ing the Cleaning and Disinfecting section of the manual understand the indications for use and the functionality of the Breast Biopsy Patient Rest BI 320 PA PH and am aware of the components of the Breast Biopsy Patient Rest BI 320 PA PH the installation of the Breast Biopsy Patient Rest BI 320 PA PH the localization and biopsy process the application on patients the cleaning instructions the disinfection instructions the complete setup of the Breast Biopsy Patient Rest BI 320 PA PH Sj the sterilization instructions that it is NOT NORAS responsibility for timely replacement of worn out parts NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 107 Operator Training Outline Title Name Department Date amp Signature LContac Person E Mail Address Phone No Customer Trained by NORAS Application Trainer Date amp Signature NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 108 Your Notes NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 109 Your Notes NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 110
57. th Grid Biopsy System lateral medial cc Perform several biopsies or wire placements at various lesions in one step R disposable reusable The Grid Biopsy System lateral medial cc like all grid solutions allows multiple biopsy access points within a single procedure It is possible to perform biopsies from all sides The unit can rotate 360 in 15 increments 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 Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 15 Device Description Grid Method with Grid Biopsy System Height Adjustable lateral Perform several biopsies or wire placements at various lesions in one step R disposable reusable The Grid Biopsy System Height Adjustable lateral guarantees ideal lateral access In particular areas close to the thorax can be well targeted with this grid solution A grid needle block set consisting of 18G 14G and 12G tubes is available as reus able autoclavable or disposable sterile version The fixation of the breast is done through the grid on the lateral side and horizontal or vertical slat plates on the medial side NORAS mri products Breast Biopsy Patient Rest BI320 PA PH Device Description
58. th of 22 mm from the tip of the marker to the back where the pivot point of the mechanic is located 83933 Breast Biops y Fallent REST DIOZU FA F A Localization and Biopsy Process 18 While creating this new line if you are advised on an existing line so please award a new random number for the line from step 15 Name 83933 Achieva Confirmation Dialog Line 83933 already exists Do you want to overwrite it Proceed breast BIOPSY Fatient Kest DIOZU FA FA 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 17 4 mm This is the amount you need to move the Post amp Pillar positioning unit posterior toward the ceil ing K io 0 0 nl inanan Name 83934 Breast Biopsy Patient Rest BI320 PA PH DIGdol B lOopsy Fatlient REST DIOZU FA FRA Localization and Biopsy Process 20 After movement and angulation of the marker perform a control scan in order to check that the marker points at the lesion Now determine similarly to step 11 the puncture depth from the skin surface to the center of the lesion here 38 mm without Offset Name 83935 Localization and Biopsy Process 21 After the puncture with the trocar perform another control scan in order to check that the end of the cannula lies right in front of the lesion
59. that when the biopsy device is turned into the cranio caudal direction the MRI images must be made in the sagittal direction to correspond with the follow ing description During the examination some parts of the breast may come into contact with the surface of the base plate with the low probability Before each examination of the patients the base plate must be covered with a clinical cloth Needle penetration at incorrect location The breast must be correctly immobilized If the breast is not immobilized properly it might slip and the data delivered by the MRI might be inaccurate Ensure that as much breast tissue as possible is held between the slat plates screw the filled marker into one of the needle guides on right or left side and reset the scales of the guide base guide bar and the angulation angle of the needle guide of the Post amp Pillar positioning unit in horizontal and vertical direction to zero see ill below NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 39 Localization and Biopsy Process Marker in the center of the device Set angulation an gle guide base and telescope bar to O position Figure above Needle guide on zero position with marker on the right Now mount the Post amp Pillar positioning unit onto the pins of the fixation plate NORAS mrr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 36 Localization and Biopsy Process
60. the way of the biopsy or if you prefer to continue with an angu lated biopsy for any other reason you can also work with an angulation of 15 or 30 degrees toward the top or the bottom 13 Now an angle of 15 degrees in this example has to be drawn to the original marker line To do so one needs to use the tool which you find on right clicking gt More gt Line Settings Hardcopy Image Remove Image View Reset Window Reset ROI Rectangle Line Distance Profile Annotate Text View Settings Window Settings ROI Settings Annotation Settings Copy From Temp Delete Graphics From Image Delete Graphics From Case Localization and Biopsy Process 14 Select the middle button Angle i Angle Name 83923 f m l lt froadgnc LIAN J TION JAC DIDIA LD A A un Dreast B IOPSV ratlent NEST DIS U F A I Localization and Biopsy Process 15 Draw a line through the marker to the center of the lesion Name 83923 L rOonace LIAN Y J TION JAC DIDIA LD A A un Dreast B IOPSV ratent Kest DIOZU FA CI Localization and Biopsy Process 16 Draw the second line so that you get a 15 degree angle at the intersection of the lines Name 83923 Ze lt froadgnc LIAN Y J TION JAC DIDIA LD A A un Dreast B IOPSV ratent Kest DIOZU FA CI Localization and Biopsy Process 17 Choose the distance tool und draw the new line with a leng
61. tridge marker use a screwdriver with a blade width of 5 6 mm The cartridge marker can be released either with a screwdriver or with a needle sleeve of the unit Be sure to use only MR compatible screwdrivers If no MR compatible screwdrivers are available you must fill the oil marker outside of the MR room Post amp Pillar Marker Marker Bolt Marker with Grid Cartridge Marker and Grid Marker block NORAS mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 29 Start Up 5 4 2 Filling Markers The markers must be filled with diluted MRI contrast agent to make them visible in the MRI To do so fill a syringe with contrast agent diluted 1 200 and then slowly fill the marker with the syringe up to the edge of the marker thread starting at the bottom of the marker Rotate the syringe during filling to prevent the formation of bubbles Grid Markerblock Marker Bolt Marker inside the Cartridge Marker r Grid 5 4 3 Closing Markers You can close the Post amp Pillar Marker the Grid Marker Block or the Bolt Marker by hand Post amp Pillar Marker Grid Markerblock To close the marker cover in the grid use a screwdriver with a blade width of 8 6 mm and to close the cover of the cartridge marker use a screwdriver with a blade width of 5 6 mm Be sure to use only MR compatible screwdrivers If no MR compatible screwdrivers are available you must fill the oil marker outside of the MR room NORAS mrr
62. ts 70 Localization and Biopsy Process Please make sure that when using plastic cannulas that no artifact is noted after re moving the trocar Close the cannula with the provided accessory plastic stick after removing the trocar The plastic stick is then to be removed and the puncture or wire localization can be performed through the cannula 6 1 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 mr Breast Biopsy Patient Rest BI320 PA PH p r O du C ts 71 Localization and Biopsy Process 6 2 With Grid Biopsy System Permanent damage to the system The system may only be assembled by trained medical person nel Incorrect assembly and operator errors made by untrained per sonnel can permanently damage individual parts of optional components and of the device itself Training of personnel The users must be trained before using the device detailed training of the personnel for existing components The localization process with medio lateral alignment of the fixation unit lateral ac cess and the use of the sagittal s
63. zontal Post amp Pil lar Positioning Unit Post amp Pillar Marker Needle Guide Sleeve Set Grid Localization Needle Block Set Grid Markerblock Blocking Plate Autoclave Box Needle Guide Post und Pillar Adapter for Ethi con SenoRx ATEC Vacora Grid Needle Block Adapter for Ethicon SenoRx ATEG Vacora 88 Cleaning Disinfection and Sterilization Cleaning and Disin fection manual The following parts may not be inserted in immersion baths and be held under running water all coil types all coil cables and plugs insertion plate coils 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 abrasive cleaners or other organic sol vents and solvent based cleaning agent e g benzene alcohol stain remov ers may not be used Detergent Example Sekusept PLUS Ecolab 4 0 vol Korso lex Plus 3 0 vol with exposure time of 15 minutes For this pur pose all aldehyde free surface dis infectants which have been ap proved and released by the RKI and the VAH can be used in accordance with the instructions on the label The cleaning of the parts could be done manually in immersion or ul trasonic bath for 10 30 minutes preferable at temperatures of up to 50 C Procedure 1 Rinse excess soil from compo nents 2 Using soft brush apply det

Manual BI 320-PA-PH - Noras MRI products

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