Vacuum Gun-Adapter for SenoRx EnCor - Noras MRI products
Contents
1. c DIE TPO SP H348 EXE Fav A Hany E nn Jm P a E Ri a en id ELO Fu Gm iy 1 EXC zm D i fi ES n D io a ee gt En Zu re u Fs B R i 1 1 yee i v j M i i P I T E Em dm Ed RE h j D B Y i Dj a r 4 g x D RI eee P mi E Sep zu Re zi aos 1 EN g O jl ae gq 4 E Ga L ig p E ead CO ei Vos E a 52 Localization and Biopsy Process Now replace the complete Post amp Pillar needle guide for your SenoRx EnCor vacu um biopsy system with the second sterile needle guide Danger of infection Before intervention the complete Post amp Pillar needle guide has to be replaced with the second sterile needle guide Failure can lead to infections of the patient Now puncture the breast with the trocar using this offset corrected depth starting at skin surface Afterwards pull the needle out of the trocar and insert the plastic bar into the cannula instead The plastic bar causes less artifact than the needle and prevents blood back flow into the cannula 11 Perform a control scan in order to check that the end of the needle is positioned in front of the lesion After the successful control scan the plastic bar can be removed from the cannula and you can start with the biopsy or inserting a localization wire Perform the biopsy in accordance with the instructions of your needle and or vacuum manufacturer Please note the application of the NORAS Post amp Pillar vacuum gun adapter f2. Vacuum G 11r A nan ar far C ann D E Gun Adapter for SenoRx Ei jm E E di aR Ss m LA Ar A EB HA Y E i E AN m E AD E G E E N Lv l i y a 1 m MU zu m Em UN SA NM EN P T E NM y y j he eat WEM on y Iu DM BER 4 b y B E i a Wu E us 2 ew E AAVERE Do E a E 2 ld m i E dar u milk y X u a 5 E n me 2p E EN UD NE aru l 3 x P de f J g amp C due EnCor iJ Le gt a Be 4 Y j E i GP GA Le ni 2 p E wd a 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 sub tracted 8 Move the Post amp Pillar positioning unit with the marker according to the calculated coordinates in our example 8 7 mm upwards posterior and 59 2 mm towards the head TRUM UR A w LLL 4 In di nu 5 NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 50 Localization and Biopsy Process 9 Perform a control scan in order to check that the marker points at the lesion Test Biopsiet 23456 11414911 STUDY 1 1706 2015 12 NL 3 E 2 7l 23 Id 70 ERI O
3. Vacuum Gun Adapter for SenoRx EnCor p r odu C ts 3 Content NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 4 General Information 1 General Information A prerequisite for safe and trouble free operation is the proper observance of instruc tions in particular the following points e To obtain accurate results you have to use only the immobilization and positioning systems which are intended for use with the adapter e Before examination with patients it is recommended to train on a phantom Phan toms are available via NORAS MRI products GmbH If there is no phantom availa ble a grapefruit or similar can be used in order to be familiar with the system e Please note that the Post amp Pillar marker is not screwed but plugged in with a clearly audible click until it stops and then clamped by the lateral fixing screw of the needle guide e The localization process is described in this operator s manual e Toreceive information about new developments or accessories please send an e mail to mri noras de e All parts supplied here can be steam sterilized and must always be cleaned be fore use and may only be applied sterile The kit consists of two adapters so that one adapter can be sterilized while the other one is in use e Assistance to malfunctions such as The needle misses the lesion you will also find in this operator s manual e For each new patient all components of the ada
4. Ya d B 1 BH en ud a a 5 sa BU 2 2U g aa 7 e gt m PN amp AN a a EN a E E EN A c O Rx en Cor 3 p BU i WP C DE ud e 43 Y a Vacuum Gun Adapter ror Seno LI 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 con text menu select copy or Strg C By doing so the line is copied and can be past ed into other slices Test Biopsie1 23456 Avanta 11111911 o 103r MR E13 STUDY 1 is 17 05 2015 fine ae REN ee vH chirurgie 1 2 23 MA 33 1104 1 Distance 10 73 cm 1 Miniiax 07134 MF 1 00 LE TP Bj A1 PFP eee 1 4ml Dotarem f3d1 125 fis ME meri EA i ae i s Th B M ER Ni P aS Ar m su E uU D y P E e MN ir M NY l ij K v A LE mmm E A NS Pio n m Pa E UN Wy pio B M b S R fi i f Ese TE EU gg k re ea E i n D E X 2j ta amp n Wee i 1 c E n bs l i n 1 f Dj tie t nj amp iy 1 g d ae NE m aped rm fg oam di E 1 uM pon Zar IE Fa RR eo Mani m Giir Ada n tar far CannR wv En r mG h 6 d a F a E 2 amp y p A Vacuum Gun Ada pter Tor DENORX LENCO n fe EH CI Ge OU t amp aw 44 Localization and Biopsy Process 3 Scroll through the other slices until you find th
5. duc bw L a F P M p j n Alan 2 a ER m RO NY Mo B Q Gun Adapter for SenoRx EnCor i f DI r 4 Gi Y E Ww 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 measurements 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 Biopsiet 23456 Santo 8115114311 0 105 ME B19 STUDY 1 LPH 17062015 el 12 36 28 PREEN Z3 MA 70 r104 1 Distance 10 73 cm 1 Minidax 0 134 2 Distance Don 2 Mirmlexas enter SCM MF 1 00 TR 7 8 Tic TA Dis TP D IF 01 31 Mum Eh 3419 0 5 e MORDIS Z2 Semia A1FFFP 14ml Dotarem cl 125 D Jas a Pio im J zi Fr F g F A rey n p hoe Pu ve See hs EA E E SN EUM UL BR b I i ay N 8 gt RUN Wi MA 4 d l 1758 ar i EN m 3 ho m u y E N MT 3 E OO Sm BE E i Wi Wh E Y B Im A 1 1 ey bp P l Fi Ea P EE WE OM BUT uu je avs i 2 t m fo u i i hu men E m AF hol B VERD 5 Un BU EE E 25 uq i _ _ M _ a V gti gerelid Tf zn Vari m Giir Adantar far Cannk EnON A d t yg Em MI l E EE Sen Vacuum Gun Ada pter Tor el IORx EnCor i ro EH WM OU OU t amp aw a DAN Y W RA Br Localization and Biopsy Process 6 In order
6. the breast NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 62 Localization and Biopsy Process 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 Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 63 Cleaning Disinfection and Sterilization 5 Cleaning Disinfection and Sterilization WARNING The procedure must be followed as described In case of inadequate cleaning disinfection or sterilization you carry the risk of infection Non compliance with the cleaning instructions may destroy the system No warranty service will be provided for dam ages due to improper disinfecting Please always wear protective gloves and carefully comply with the application times for Hepatitis B and HI viruses See the instructions for use of the respective disinfectant solution Limitations on Frequent processing can have an impact on these prod reprocessing 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 a
7. 103 MF 1 00 TR 7 TE 4 8 TA 01 31 Ei 348 0 MINORMIDIS2D Ad PFP C 2BL fl3d 125 E E A B EN A2 B EM A i Fa Y n KL Me wet M F b ua N EN ie uH TOS ar n m Din _ Adantar far Cann Eara Vacuum Gun Adapter for SenoRx EnCor 14ml Dotarem A fan en Pa puru N AS I m 5 A d r E y 1 EE A2 i A CI za EP ZU b Ay na I e S LAS o a iy if CR k E LJ bi Hd BY N d D Ww M 4 X VINE Avanta ME B19 HFF LFH vB Chirurgie 1 E SCM DE TPO P H34 8 SL 1 Bi Foy 2 2n 8700 4 oadp 255s Tra N E s i 3 w nn Tn TF gg a C p r D f g De p f ro al i Gs amp a i O1 Localization 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 10 mm in order to position the cannula lie in front of the lesion Test Biopsiet 25456 11414911 STUDY 1 17408 201 5 12 Ta B Pia i 23 WM 707104 MF 1 00 TR r 8 TE 4 6 TA 01 31 zn 349 0 io RMIDIESZD Ad PFP C 2BL fl3d 1 25 Vacuum Gun A d antar far Adapter TOI 1 10547 EB UN Rh P b Y N j vl M GS E UN E S oenomx r cni Lor 1 Distance 1 tinta Offset 14ml Dotarem Avanta MR B19 HFF LPH vH Chirurgie 1
8. EnCor with the instructions on their labels Grid Needle Block Adapter for SenoRx Procedure EnCor 1 Load components such that hinges are open and cannulas and holes can drain Needle blocks could possibly be pre cleaned by syringe or water nozzle 2 Run cycle minimum 5 minutes clean and 5 minutes rinse 3 When unloading check cannulas holes etc for complete removal of visi ble soil If necessary repeat cycle or use manual cleaning NORAS mr Vacuum Gun Adapter for SenoRx EnCor pro duc ts 65 Disinfection au tomated All PEEK cleaned chine Vacuum Gun Adapter for SenoRx EnCor can by Cleaning Disinfection and Sterilization parts made of be ma Disinfectant Depending on RDG and Vario TD program you can select on disinfectant which has been approved and released for automated disinfection Procedure If automated disinfection is em ployed a final rinse at 90 C for 5 minutes may be used to effect thermal disinfection The parts such as needle guides and needle blocks can be disinfected in accordance with the same procedure in an ultra sonic bath The assembly must be disassem bled into its individual components so that an optimal disinfection is guaranteed NORAS mr products Applicable only for Post amp Pillar Adapter for SenoRx EnCor consisting of Post amp Pillar Marker for SenoRx EnCor Post amp Pillar Needle Guide
9. Forschungszentrum fuer Magnet Resonanz Ivi P Bild Ans m Hp Manual Biopsy N Em BW 130 0 M NORM DIS2D 2BL 2BR tse2d1_7 180 MRI Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 19 Localization and Biopsy Process 3 Draw a line straight through the pointer Manual Biopsy A MRB Forschungszentrum fuer Magnet Seona 01 01 1980 31Y MEE 11 56 ur Min VISce Of 5 9 NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 20 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 Mise d ra MR D11 HFP id PH Ausschneiden V Kopieren Einf gen L schen Markieren Eigenschaften Kommentar editieren NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 21 Localization and Biopsy Process 5 Scroll through the other slices until you find the lesion that you want to perform a biopsy on Right click on this slice and select paste Manual Biopsy A MRB Forschungszentrum fuer Magnet Son 01 01 1980 O 31Y STUDY 1 12 08 2011 Serie ausw hlen 14 14 15 i 10 IMA 26 35 Alle Folgenden ausw hlen Markierte Objekte ausw hlen Nicht markierte Objekte ausw hlen Kopieren Einf gen Markieren Do
10. determine the exact position of the biopsy needle in front of the lesion e After successful control scan the plastic bar can be removed from the cannula and you can start with the biopsy or inserting a localization wire Perform the biopsy in accordance with the instructions of your needle and or vacuum manufacturer NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 61 Localization and Biopsy Process For biopsy with the NORAS vacuum gun adapter grid system for SenoRx EnCor with 10G needles 10G needle blocks are used When using 7G needles a special 7G NORAS needle block available on request is used to fix the SenoRx EnCor vacuum biopsy system After completion of the biopsy clean the device parts as described in chapter 5 Cleaning Disinfection and Sterilization 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 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
11. p r oO du C ts 6 Device Description 3 Device Description 3 1 Definitions and Symbols The following symbols are used in this operator s manual ISO 7000 2497 Date of Manufacture EN ISO 7000 1641 Operator s Manual Caution Read the accompanying ISO 7000 0434B documents Waste products should not be disposed of I E C with household waste e g at a local FS authority collection point t This way u DIN 55402 y up ISO 7000 0621 Fragile handle with care ISO 7000 0626 otore in a dry place ISO 7000 0632 Temperature Limit DIN EN 980 5 10 Item Number Conforms with the essential requirements of C 4 Council Directive 93 42 EWG of 14 June 1993 concerning medical devices NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO d u C ts 7 Device Description 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 NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 8 Device Description 3 2 System Components 3 2 1 Vacuum Gun Adapter for Post amp Pillar System For 10G Vacuum Gun Adapter for Post amp Pillar System Ref MR10062 SE Post amp Pillar Marker for 112426 SenoRx EnCor Age Post amp Pillar Needle Guide MR10014 SE for SenoRx EnCor de For 7G Vacuum Gun Adapter for Post am
12. the patient NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 54 Localization and Biopsy Process 4 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 slices is next described This applies for the use of the system with the grid for the examination of a single breast In the case of the simultaneous biopsy of both breasts lateral access use a second fixation unit and a second grid on the other side and proceed in the same way NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 55 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
13. 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 Along the biopsy process the plastic cannula contacts with the needle guide Thus it is obligatory that the Post amp Pillar marker is sterile Marker in the center of the device oet angulation an gle guide base and telescope bar to O position Figure above Needle guide on zero position with marker on the right NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 16 Localization and Biopsy Process Now mount the Post amp Pillar positioning unit onto the pins of the fixation plate NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r o du C ts 17 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 CEUTE Biopsy A MRB Forschungszentrum fuer Magnet Resonanz SEM 01 01 1980 O 31Y MR D11 HFP LPH v Localization and Biopsy Process 2 Start the distance tool menu right center Extras distance ruler A MRB
14. with the instructions of your needle and or vacuum manufacturer Please note the application of the NORAS Post amp Pillar vacuum gun adapter for SenoRx EnCor with 10G or 7G doesn t require a needle guide sleeve The cannula of the vacuum biopsy system is directly inserted into the Post amp Pillar needle guide The cannula is fixed by the locking screw of the angle adjustment After completion of the biopsy clean the device parts as described in chapter 5 Cleaning Disinfection and Sterilization 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 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 NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 30 Localization and Biopsy Process 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
15. 59 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 NORAS mr Vacuum Gun Adapter for SenoRx EnCor pro duc ts 60 Localization and Biopsy Process e Push the 10G needle block into the corresponding opening in the grid and using the toolbox determine the desired penetration point on the needle block e f 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 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 After re inserting the needle block puncture the breast with the trocar of your vacuum biopsy system e A stop ring on the cannula marks the penetration depth to be used Insert the cannula with the corresponding metal needle up to 10 mm in front of the lesion After fixation on the NORAS vacuum adapter the penetration depth of the cannula is additionally secured For a control scan the metal needle has to be replaced with a plastic bar Risk of burns The metal needle of the trocar has to be replaced with a plastic bar for the control scan There is a risk of burns for the patient e he control scan is used to
16. RAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du Cc ts 74 Your notes NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r o du Cc ts 15 Your notes NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r o du Cc ts 76
17. Ul D VCI IUTNA LDII L JOI a EN pu d uu c Localization and Biopsy Process 8 The lesion you have chosen in step 5 is located in our example on slice position 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 A MRB Forschungszentrum fuer Magnet Resonanz ra MR Bii HFP LPH e MRI Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 29 Localization and Biopsy Process 9 Move the Post amp Pillar positioning unit with the marker according to the calculated coordinates in our example 22 mm downwards anterior and 18 mm towards the head IVA tione M o N TM o Mmmm LE ILE Tnm MAL NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 26 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 01 01 1980 31Y STUDY 1 12 08 2011 4 24 30 11 IMA 26 35 MRI Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 27 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 Subtract an offset depending on the biopsy system normally about 5 10 mm in order to posi tion the cannula lie in front o
18. Vacuum Gun Adapter for SenoRx EnCor Operator s Manual Revision 03 e O O C LLI x 24 O C D ep Q U O E 5 O O U gt ep lt 14 O A NORAS mr e pr Oo d u C ts Technical changes reserved Date issued August 2015 NORAS mrr Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 2 Content Content 1 General Information ee re eee ec En nn 5 2 Intended Use Indication for Use 6 3 DEVICE ESCH OUO MM erc 7 3 1 DS TINIGIONS And SYMDOIS nennen en ee ee 7 3 2 BYS LEN OMI ON ES SEE E 9 3 2 1 Vacuum Gun Adapter for Post amp Pillar System eesssussse 9 3 2 2 Vacuum Gun Adapter for Grid System cccccccccecceeceeeceeeceeeseeeseeeaeesaees 10 3 3 Salley INIOTMAUON E m UU TT MT 11 4 Localization and Biopsy Process eere eene enne 13 4 1 VE POS amp Pillar BIODSV SYS s 0 09999319992000 309 999 09 9 099 09 280 59053050 05 02552 14 4 2 Yen Grid BIOBSY SYS 211 en m 55 5 Cleaning Disinfection and Sterilization 64 6 Storage and Waste Disposal u 22u022000000n0n0n0nanunnnnnnnn nun nennen nenn 72 6 1 OAE ee ne ee 72 6 2 WV ASUS LIS OO SAI een a 72 7 Important Addresses List ualianskur bupex nettet Eia ENE RU EARVR nn anna pre bPE UD anne 73 MRI
19. ated by Dr Schwarzkopf Markers must be emptied prior to sterilization Storage oafe dry dust free and protected from light Constant temperature 23 C 2 C Constant humidity below 60 rel humidity When sterilizing multiple instruments in one autoclave cycle Information ensure that the sterilizers maximum load is not exceeded Manufacturer See chapter 7 Contact NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r o du C ts 70 Cleaning Disinfection and Sterilization 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 user and or end user Danger of destruction Improper sterilization may result in malfunction of the device Non respect of the sterilization instructions may cause the de struction of the device No warranty service will be provided for damages due to improper sterilization Danger of infection The sterilization instructions must be followed In case of inadequate sterilization the risks of infection arise to user and or end user NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 71 otorage and Waste Dispo
20. e lesion that you want to perform a biopsy on Test Biopsiet 2456 Avanto 8115114311 0 103v ME B19 STUDY HFP STUDY 1 son el 12 36 28 vB Chirurgie 1 23 IMA 70 1104 E SCM DE TPO SP H34 8 SL M T api 200 mm LAS AA PFP Es Tra M 14ml Dotarem m fl d 125 i ETT EA V E T MUNORIMIDISZD TE A o ve VA Fr pm Ta B ry oN M af i A E FR amp a m mA M M D N ir er I VA a of A b a N m Al I iz py i n p Ww To S Ta l 4 i 1 O We UR AU EM A ANM ML A by b N kp B AA zum gt 5 Y ii VIF i Un 1 77 a d W E Sep c al Em m dm ith ce M p i i u i B y Val EE ae ar n m im Adnantar far Sana 1 a PME JI E i AL Vacuum Gun Adapter for SenoRx E Cor VE pi f S Li ow to 45 Localization and Biopsy Process 4 Right click on this slice and select paste or Strg V Avanta MR B19 Test Biopsiet HFF LPH vB Chirurgie 1 E 23456 11 11 1811 STUDY 1 TGI 15 12 36 28 z 70 104 1 Distance 10 75 cm 1 Min ax M134 23 IM 1 3vY SCM MF 1 00 DE TPO SP H34 8 SL 1 Bi a 102700 m mm 18 C 266 d E d 348 0 MORDIS 2D ATIPFP C 2BL fl3d1 25 1 4ml Dotarem BAT n2 N EA N A wn E m 4 IN i K m D Pane E ELI R Un B tuus NI EB m Zu Mn E a g int wi i po EM hal a gt EN n Al P ii E UM OD le AM MA pe b ire N B Ww wu E us M wu 9 D ae E i A g Wu B B u m E if L le E i g c 46
21. f the lesion Manual Biopsy A MRB Forschungszentrum fuer Magnet Resonanz E3 132 Skyra Ss Ma 01 01 1980 O 31Y MR D11 a HFP f 08 2011 LPH 30 Vy 11 IMA 26 35 Manual Biopsy 1 Distanz 16 77 cmh 1 Ming Mex BUZZ MF 1 00 TR 3710 0 TE 13 0 02 09 Now replace the complete Post amp Pillar needle guide for your SenoRx EnCor vacu um biopsy system with the second sterile needle guide Danger of infection Before intervention the complete Post amp Pillar needle guide has to be replaced with the second sterile needle guide Failure can lead to infections of the patient NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 28 Localization and Biopsy Process Now puncture the breast with the trocar using this offset corrected depth starting at skin surface Afterwards pull the needle out of the trocar and insert the plastic bar into the cannula instead The plastic bar causes less artifact than the needle and prevents blood back flow into the cannula 12 Perform a control scan in order to check that the end of the needle is positioned in front of the lesion Manual Biopsy A MRB Forschungszentrum fuer Magnet resonanz ra 01 01 1980 O 31Y MR D11 HFP LPH v After the successful control scan the plastic bar can be removed from the cannula and you can start with the biopsy or inserting a localization wire Localization and Biopsy Process Perform the biopsy in accordance
22. for SenoRx EnCor Grid Needle Block Adapter for SenoRx EnCor 66 Cleaning and Dis Cleaning Disinfection and Sterilization infection manual All PEEK can cleaned manually Vacuum Gun Adapter for SenoRx EnCor parts made of be Detergent Example Sekusept PLUS Ecolab 4 0 vol Korso lex Plus 3 0 vol with exposure time of 15 minutes For this pur pose all aldehyde free surface dis infectants which have been ap proved and released by the RKI and the VAH can be used in accordance with the instructions on the label The cleaning of the parts could be done manually in immersion or ul trasonic bath for 10 30 minutes preferable at temperatures of up to 50 C Procedure 1 Rinse excess soil from compo nents 2 Using soft brush apply detergent solution to all surfaces ensuring that hinged components are cleaned in both open and closed positions 3 The part is held under running water for 5 minutes In this case the running water must flow through the cannulas The blind holes must be repeatedly filled and emptied 4 The parts must be cleaned as long as no visible blood or tissue residues more on the products to be seen For manual disinfection it is advisa ble to insert the parts for expected parts see left column in the solution immediately after use Ensure that the parts are completely submerged in the solution Take the parts from the solution after the desc
23. he 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 ceil ing 2 Distanz 2 20 cm 2 Min Max 0 1095 2 1 Winkel iS Grad 3 Distanz 2 54 cm 3 Min Maxs 9 1074 MRI Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 38 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 similarly to step 11 the puncture depth from the skin surface to the center of the lesion here 68 6 mm without offset dO LITORA Now replace the complete Post amp Pillar needle guide for your SenoRx EnCor vacu um biopsy system with the second sterile needle guide Danger of infection Before intervention the complete Post amp Pillar needle guide has to be replaced with the second sterile needle guide Failure can lead to infections of the patient NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 39 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 New arde uere After the successful control scan the plastic bar can be removed from the cannula and you can start w
24. 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 Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 31 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 calculation of coordinates If you notice during the straight biopsy that for example one of the bars of the grid is in the way of the biopsy or if you prefer to continue with an angu lated biopsy for any other reason you can also work with an angulation of 15 or 30 degrees toward the top or the bottom 13 Now an angle of 15 degrees in this example has to be drawn to the original marker line To do so one needs to use the 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 30 11 IMA 26 35 M MF 1 00 TR 3710 0 TA 02 09 SP H25 0 MRI Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 32 Localization and Biopsy Process 14 Draw the first line in this example from right to left through the marker toward the lesion NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r
25. ith the biopsy or inserting a localization wire NORAS mr Vacuum Gun Adapter for SenoRx EnCor pro duc ts 40 Localization and Biopsy Process Perform the biopsy in accordance with the instructions of your needle and or vacuum manufacturer Please note the application of the NORAS Post amp Pillar vacuum gun adapter for SenoRx EnCor with 10G or 7G doesn t require a needle guide sleeve The cannula of the vacuum biopsy system is directly inserted into the Post amp Pillar needle guide The cannula is fixed by the locking screw of the angle adjustment After completion of the biopsy clean the device parts as described in chapter 5 Cleaning Disinfection and Sterilization 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 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 NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r o du C ts 41 Localization and Bio
26. ized 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 Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 57 Localization and Biopsy Process Medial Lateral Anterior e Detect the marker block and the lesion in the MRI using sagittal slices e Mark the lesion with a permanent auxiliary point from the software toolbox of your MRI system e Copy paste the point into all slices e Goto 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 Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 58 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 Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts
27. kumente entfernen Zur ck zu Originalfensterwerte In Segment einpassen Zur ck zur Originalgr e Position Fensterwerte speichern Kommentar editieren MRI Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 22 Localization and Biopsy 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 measurements 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 TT ee NR 01 01 1980 O 31Y m ES P Manual Biopsy Ese WANA M POS won 2 cds A Alnes 0 2975 R 2 1 1 Distelz i B ren Ur leve 0 2079 MRI Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 23 Localization and Biopsy Process 7 In order to determine the shift from head to feet Post amp Pillar positioning unit to the left or to the right view the slice position of the marker and lesion at the trans versal slices The marker from step 1 is located on slice position SP Slice Posi tion H7 0 therefore 7 mm towards the head from the marker zero position A MRB Forschungszentrum fuer Magnet Resonanz xe MR D11 09 0 0 M DIS2D j ig am A E x V aniinmim Aa1riIn Anantar tar Ranney Er nr o m Hw V ac U u IT 3 ul AQ a p Le L I
28. nd comply with the appli cation times for Hepatitis B and HI viruses See the instructions for use of the respective disinfectant solution NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 64 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 be Cleaning disassembled into its individual components Needle blocks could possibly be pre cleaned by syringe or water nozzle Can nulas and wholes must be connected in accordance to rinse body Pay attention to correct flow Preparation with H202 or enzymatic cleaner could be done Cleanin auto Equipment Washer disinfector Applicable only for mated Detergent Example alkaline deter Post amp Pillar Adapter All parts made of gent such as Neodisher MediClean for SenoRx EnCor PEEK can be forte 0 2 1 0 vol 2 10 ml Il Dr consisting of Post amp cleaned by ma Weigert at 50 60 C For this purpose Pillar Marker for chine all agents which have been approved SenoRx EnCor Post and released by the Robert Koch Insti amp Pillar Needle Guide tute RKI can be used in accordance for SenoRx
29. oO du C ts 33 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 Winkel is Grad NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 34 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 NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 35 Localization and Biopsy Process 17 Now go ahead and move the second line which forms an angle of 15 degrees with the first line so that it has its left endpoint in the center of the lesion Then left click the second line Finally hold down the left mouse key and move the line NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 36 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 4 Distanz 2 20 cm VINA ELLOS TPO SP H25 0 NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 37 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 t
30. or SenoRx EnCor with 10G or 7G doesn t require a needle guide sleeve The cannula of the vacuum biopsy system is directly inserted into the Post amp Pillar needle guide The cannula is fixed by the locking screw of the angle adjustment NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 53 Localization and Biopsy Process After completion of the biopsy clean the device parts as described in chapter 5 Cleaning Disinfection and Sterilization 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 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
31. or 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 Ensure that the pack is large enough to contain the in strument without stressing the seals In sets The parts may be loaded into dedicated instru ment trays or general purpose sterilization trays Ensure that cutting edges are protected and do not exceed the maximum loading per tray Wrap the trays using appro priate method See also guidance of DGSV RKI and DIN EN ISO 11607 1 NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r o du C ts 69 Cleaning Disinfection and Sterilization Sterilization Steam sterilization The following items may be subjected to steam sterilization but not on basis of STERRAD Post amp Pillar Adapter for SenoRx EnCor consisting of Post amp Pillar Marker for SenoRx EnCor Post amp Pillar Needle Guide for SenoRx EnCor Grid Needle Block Adapter for SenoRx EnCor Procedure 134 C 3 04 bar 5 min The effectiveness of steam sterilization according to the proce dure mentioned above has been valid
32. p Pillar System Ref 113315 Post amp Pillar Marker for 113682 SenoRx EnCor Ae Post amp Pillar Needle Guide 117390 for SenoRx EnCor e Note One set consists of two adapters NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 9 Device Description 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 needle guide 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 3 2 2 Vacuum Gun Adapter for Grid System For 10G Vacuum Gun Adapter for Grid System Ref MR10061 SE Grid Needle Block for MR10069 SE SenoRx EnCor 5 holes Grid Needle Block for 5 MR10070 SE SenoRx EnCor 4 holes Operator s Manual Note One set consists of two adapters NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r o du C ts 10 Device Description 3 3 Safety Information Please consider the following
33. psy Process 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 Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 42 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 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 toward an terior 1 Perform a measurement with transversal slices and look for the slice where you can see the marker est Biopzie1 23456 Avanta MR B13 11515311 o 103 STUDY 1 n HOB 2015 VEL n hirirnna 3E 28 B Chirurgie 1 MUR gt 13 IA 337104 WF 1 00 DE TPO E E48 cou SP F244 SL1 6 Ww 349 0 umoRIMDISE2D Fan i 1 FF P 16 m dnt 256s i MSIE 14ml Dotarem qM TTS fl3d1 125 fo 3355 P WA FR E ED E h E Y Pa m Rh b an 3 EY ne E L JJ 3 g a oa EN ni F FA MDF E Rh ZA EH A Vere B AA HV te E NM i VINE i 1 m Ed m
34. pter as well as the Post amp Pillar marker have to be disinfected according to the disinfection instructions Chapter 5 Please always follow the disinfection instructions for the positioning and fixing unit Prescription use only Country specific laws restrict this device to sale by or on the or der of a physician or with the descriptive designation of any oth er practitioner licensed by the law of the country in which he practices to use or order the use of the device This device may only be distributed to persons who are licensed practitioners or to persons who have a prescription or other order from a licensed practitioner to purchase it NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 5 Intended Use Indication for Use 2 Intended Use Indication for Use Br The adapters for SenoRx EnCor have been p developed for the use with the SenoRx EnCor _ ee vacuum gun from C R Bard in conjunction with the NORAS Biopsy Systems Post amp Pillar Grid Figure above SenoRx EnCor vacuum gun from C R Bard The correct and safe use of the vacuum gun adapter for SenoRx EnCor for breast biopsy requires advance expertise of the operator and detailed knowledge of the op erator s manual These instructions must be read thoroughly before using the vacu um gun adapter for SenoRx EnCor Carefully read the C R Bard operator s manual NORAS mr Vacuum Gun Adapter for SenoRx EnCor
35. ribed time NORAS mr products Applicable only for Post amp Pillar Adapter for SenoRx EnCor consisting of Post amp Pillar Marker for SenoRx EnCor Post amp Pillar Needle Guide for SenoRx EnCor Needle Block for SenoRx Grid Adapter EnCor 67 Cleaning Disinfection and Sterilization 15 minutes and rinse by water the quality of water must be at least equal to drinking water better would be using aqua Demineralized wa ter Changing in color due to con tinuous disinfection cannot be ex cluded but can be largely prevented by sufficient rinsing after each use he 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 Vacuum Gun Adapter for SenoRx EnCor p r o du C ts 68 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 f
36. sal 6 Storage and Waste Disposal 6 1 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 vacuum gun adapters 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 draw ers or similar places e Relative Humidity Min 10 Max 95 e Air Pressure Min 500 hPa Max 1060 hPa 6 2 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 We would be happy to provide you with additional information about disposal upon request NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r o du C ts 72 Important Addresses 7 Important Addresses Manufacturer product development and production products NORAS MRI products GmbH Leibnizstrasse 4 97204 Hoechberg Germany Telephone 49 931 2 99 27 0 Telefax 49 931 2 99 27 20 E Mail mri noras de Internet www noras de NORAS mr Vacuum Gun Adapter for SenoRx EnCor products Your notes NO
37. tandard 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 10 mm steps up to max 30 mm in posterior direction Only with this application the screws are necessary for a safe fixation NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 13 Localization and Biopsy Process 4 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 Pillar Biopsy System for the examination of a single breast NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 14 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 olide the second fixation plate with the curved slat pla
38. te 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 Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 15 Localization and Biopsy Process Cranial caudal access To enable cranial caudal access proceed as described previous to provide medi al lateral access Please note that when the biopsy device is turned into the cranio caudal direction the MRI images must be made in the sagittal direction to correspond with the follow ing description 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
39. 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 mrr Vacuum Gun Adapter for SenoRx EnCor p r o du C ts 56 Localization and Biopsy Process Cranial caudal access olide the fixation plate with the medial slat plate reusable or with a second disposa ble 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 Needle penetration at incorrect location The breast must be correctly immobil
40. to determine the shift from head to feet Post amp Pillar positioning unit to the left or to the right view the slice position of the marker and lesion at the trans versal slices The marker from step 1 is located on slice position SP Slice Posi tion F24 4 therefore 24 4 mm towards the feet from the marker zero position est Hiopzie1 23456 Santo 11515311 0 103 MR B19 TH IPs HFF s TUDY 1 i 71068201 5 ono FLPH vB Chirurgie 1 uch 2 iz vo 273 MA 33 104 SOM WF 1 00 HE a Er EE ul iN ORM DISD Fo 200 200 m MATE 1 PFP is Tra ME 14ml Dotarem 4 777 tad 125 355 cS N R F T9 ES p y E 4 Zu i mnm Jm if iT G NEM Ff l MI ri f 1 E nen a E n d ral i B BI art mere Par VA A F O Tel E E Ss a JR ATi iiS Arantar far Qann ear O 1 E em T Vacuum Gun Adapter for SenoRx EnCor V p i t GH NN te amp S 48 a ga Localization and Biopsy Process 7 The lesion you have chosen in step 3 is located in our example on slice position 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 11414911 STUDY 1 1706 2015 12 36 29 73 lM 70 ERE OQ 103 Avanta MR B19 HFF LFH vB chirurgie 1 MF 1 00 TR 7 8 TE 4 8 TA 01 31 Ei 348 0 MINORMIDIS2D Ad PFP C 2BL fl3d1 125 14ml Dotarem
41. to the patient and or to the user Combination with other devices The use of other components as listed in this operator s manual is only allowed with written permission 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 4 Non compliance with theses instructions may lead to bodily injuries of the user or patient Bodily injuries due to accessories When using accessories always observe the manufacturer s in structions NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r Oo du C ts 12 Localization and Biopsy Process 4 Localization and Biopsy Process Permanent damage to the systems The fixation screws should be removed from the base 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 s
42. when using the Vacuum Gun Adapter for SenoRx EnCor Post amp Pillar amp Grid System Device damage Only trained personnel may be assigned to handle the system Operating errors may cause permanent damages to the device Bodily injuries Only trained personnel may be assigned to handle the system 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 components must be treated as described in chapter 5 Cleaning Disinfection and Sterilization Non compliance with the above instructions may lead to infection of the patient Please be sure to pay attention to and comply with the safety information and instructions of the MRI device manufacturer for operators patients and third parties NORAS mr Vacuum Gun Adapter for SenoRx EnCor p r oO du C ts 11 Device Description 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
Download Pdf Manuals
Related Search