Product Information 2019 - English - Noras MRI
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In the picture from left to right : Manuel Noras, Daniel Gareis, Hubert Noras Dear Valued Customer, NORAS has been present internationally for over 30 years and has built a solid reputation due to its customer-oriented service. Besides our products, our slogan „we build your vision“ reflects exactly what we offer our customers: We are a competent partner with the planning and realiza- tion of your individual ideas and concepts. Our development and production is taking place mainly in Germany. The final assembly and final inspection is done manually by skilled employees, which provides an extra quality advantage. Within this catalog, you will find a summary of our products and the necessary order information. You will also learn more about our Research & Development area and customer-specific produc- tions. We look forward to working with you in the future and to fulfill your vision. Best Regards, Management of NORAS MRI products GmbH Hubert Noras Manuel Noras Daniel Gareis 3
Company History 1986 the business sector MRI products. Founding of the NORAS Roentgen- und Medi- zintechnik GmbH. 2006 Initially, the company worked on improving Development of a Patient Rest for MR breast the MR imaging of surface coils. NORAS beca- examination and breast biopsy. me well known to MRI users thanks to its in- house development of an adjustable spine coil 2007 in cooperation with SIEMENS and the Institute Development of an 1.5T MR Breast Coil for inte- for Imaging Diagnostic in Wuerzburg, Germa- gration with the Patient Rest. ny (“Institut für bildgebende Diagnostik - Dr. Development of a positioning unit and fixation Wolfgang Keil”). This was followed by the de- device for MR biopsy with the GE 8Ch Breast velopment of 40 different surface coils. Coil. Development of the first adjustable spine coil. 2008 1990 Focus on the core competence MRI products NORAS MRI products GmbH Establishment of a branch office in Suhl, Ger- and therefore shutdown of the Suhl branch. many. Complete rebranding to NORAS MRI products Leibnizstraße 4 GmbH. 97204 Höchberg 1993 Development of a 3T Breast Coil for integration Germany General agent for MRI Devices Corporation, with the Patient Rest. USA. Tel.: +49 (0) 9 31-2 9927-0 2009 Fax: +49 (0) 9 31-2 99 27-20 1995 NORAS becomes vendor for the Siemens He- Start of developing a fixation unit and positio- althcare AG. Development of a transfer soluti- mri@noras.de ning system for MR-guided biopsy, which was on for the Philips Neurosurgery concept. Adap- www.noras.de patented 1996 under DE19626286C2. tion of the OR Head Coil to Philips 3T systems. 1998 2010 Development and production of a flexible OR Development of an improved OR Head Holder. head coil for the 0.2T Vertical Field Concerto Development of a 4Ch Dental Coil. from SIEMENS. Adaption of the OR Head Coil to Philips 1.5T systems. Hiring of a field representative for the 2001 U.S. market. Production of an OR Head Holder for integrati- on with a SIEMENS head coil. 2011/2012 Development of a 4Ch Orbit-Array and an 8Ch 2002 Elbow-Array. MRI Devices Europe GmbH (later Invivo) was Development of a new version of the OR Head established, for which Hubert NORAS was the Holder, MR guided prostate biopsy devices. managing director until 2005, besides admi- nistrating his own companies. 2013/2014 Development of the 16Ch Multipurpose-Array. 2003 Development of the 16Ch Uni-Belt and Uni-Lift Development and production of an OR Head for diagnostics, biopsy and therapy of the pro- Holder for SIEMENS, Erlangen, Germany, with state and other internal organs. an interface to Brainsuite® from the BrainLab AG, Munich, Germany. 2015/2016 Development of the Endocavity 2-Channel Coil 2004 and advanced USA market entry. Development of an 8Ch OR Head Coil 1.5T, to- Development of the Mandibula 15-Channel gether with RAPID Biomedical GmbH in Rimpar Dental Coil as well as project start of HYPMED. near Wuerzburg, Germany, for integration with the OR Head H older. 2017 Relocation to a new office, including produc- Development of the Breast Biopsy 7-Channel tion facilities, in Hoechberg near Wuerzburg, Coil BI 7. Germany. 2018 2005 Development of the OR Head Holder LUCY. Development of an 8Ch (2x4) CPC coil, rotatab- le in 2 axes for parallel imaging. Internal restructuring and establishment of 4
in summary MaMMA DIAGNOSTICS AND BIOPSY Biopsy Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Cranio-caudal Fixation Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Breast Biopsy 7-Channel Coil BI 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Breat Biopsy and Fixation Unit Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Accessories for Post&Pillar Biopsy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Accessories for Grid Biopsy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Accessories for cranio-caudal Fixation Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Breast Biopsy 4-Channel Coil BI 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Breast Biopsy and Fixation Unit Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Accessories for Post&Pillar Biopsy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Accessories for Grid Biopsy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Accessories for cranio-caudal Fixation Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Sterile Soft Tissue Instruments for Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Manual coordinate calculation for the Breast Biopsy 7-Channel Coil BI 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Manual coordinate calculation for the Post & Pillar Biopsy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Angulated, manual coordinate calculation for the Post & Pillar Biopsy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Manual coordinate calculation for the Grid Biopsy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Prostate biopsy and therapy Uni-Lift Prostate Intervention Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Universal Diagnostics and Intervention Uni-Belt 16-Channel Diagnostic & Intervention Coil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 dedicated MR receiving coils Variety 16-Channel Multipurpose Coil 1.5T & 3T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Typical Applications and Positioning Aids - Orthopedics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Typical Applications and Positioning Aids - Pediatrics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Available Coil Packages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Accessories for the Variety 16-Channel Multipurpose Coil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Mandibula 15-Channel Dental Coil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Neurosurgery Intraoperative Neurosurgery solution from NORAS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 OR Head Holder LUCY & OR Head Coil 1.5T / 3T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Optional Accessories for NORAS OR Head Holder LUCY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 OR Head Holder FLEXIBILITY & OR Head Coil 1.5T / 3T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 OR Head Holder HEIDBERG & OR Head Coil 1.5T / 3T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Optional Accessories for OR Head Holder FLEXIBILITY and Upgrade Kit HEIDBERG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Development of the Noras OR Head Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Additional content Press Reports and Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 NORAS Corporate philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 NORAS Certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 5
Biopsy Methods MAMMA Choose your preferred Breast Biopsy Method NORAS offers two different biopsy methods, each with its own advantages. Both methods are available for our Breast Biopsy Coils BI 4 and BI 7 and support MR-guided wire placement for 12, 14, 16, and 18 Gage, as well as Vacuum Gun Biopsies. The Post & Pillar Method BI 4 Highest accuracy due to millimeter-accurate el Coil For Breast Biopsy 4 - Chann coordinate adjustment Angular needle guidance 15 ° and 30 ° pos- terior and anterior Sterile disposable needle guide sleeves are BI 7 available through NORAS - Ch a n n e l Coil For Breast Biopsy 7 The Grid Method BI 4 el Coil For Breast Biopsy 4 - Chann Easy to use biopsy method Multiple biopsies in one process Sterile disposable grids are available th- BI 7 rough NORAS el Coil For Breast Biopsy 7- Chann Both methods are compatible with the following Vacuum Guns: C.R. Bard Vacora™ Suros Surgical ATEC™ Devicor Mammotome™ SenoRX Encor MRI™ 6
Cranio-caudal Fixation Units MAMMA With the NORAS Cranio-caudal Fixation Units you can optionally immobilize/fixate one or both breasts at the same time. Using this device, one can save up to 50% of scanning time, while reducing non-desired motion artifacts. l Coil BI 4 nn e ha -C 4 sy op For Brea s t Bi l Coil BI 7 nn e ha -C 7 sy op For Brea s t Bi 7
Breast Biopsy 7-Channel Coil BI 7 NORAS product solutions for MAMMA Exclusively as OEM product for the new Siemens MRI scanner generation Vida and Sola Please contact your Siemens The Noras Breast BI 7 MR Coil is an innovative solution designed to offer flexible representative for more information use to meet the needs of the procedure to be performed in your clinic. Using the same set of comfort cushions, it can be seamlessly combined with the Breast 18 imaging coil from Siemens. You can obtain all Breast Biopsy and The rigid coil frame forms a high element-density, 7-channel „phased array” con- figuration for high resolution imaging. One sided medial and up to two-sided Fixation Unit accessories directly lateral biopsy access is possible. from NORAS. We will be pleased to give you personal advice. Patented lighting system integrated Post&Pillar and Grid Biopsy System The Post & Pillar biopsy system is designed for targeted needle guidance, which can be moved both left-right and anterior-pos- terior. Additionally, it supports angulated biopsies. As an alternative, disposable biopsy grids can be used to perform biopsies also at numerous lesions at the same time. Disposable adapters for all compatible biopsy needles and vacu- um guns are available directly from NORAS. Fixation Units: medio-lateral and cranio-caudal Specially developed fixation units for medio-lateral or also cranio- caudal fixation of the breast are available as an option to avoid motion artifacts and reduce scan time. 8
Breat Biopsy and Fixation Unit Sets MAMMA for Breast Biopsy 7-Channel Coil BI 7 part number Breast Biopsy Set for Breast BI 7 on request Cranio-caudal fixation Breast BI 7 on request Accessories for Post&Pillar Biopsy System for Breast Biopsy 7-Channel Coil BI 7 part number Post&Pillar Needle Guide Pillar Breast BI 7: autoclavable 118621 Post&Pillar Needle Guide Breast BI 7: autoclavable 118654 Post&Pillar Marker Breast BI 7: autoclavable 118946 Slat Plate Breast medial BI 7: autoclavable 118649 Slat Plate Breast lateral BI 7: autoclavable 118622 9
part number MAMMA 18G 118952 16G 118953 18G 16G Post&Pillar Needle Guide Sleeves disposable BI 7: sterile; 5-pack 14G 118954 12G 118955 14G 12G C.R. Bard Vacora 118956 Post&Pillar Needle Guide Sleeves disposable BI 7: for use with MR Suros Surgical ATEC 118957 compatible Vacuum Guns ; sterile; 5-pack SenoRX EnCor 10G 118958 SenoRX EnCor 7G 118950 Accessories for Grid Biopsy System for Breast Biopsy 7-Channel Coil BI 7 part number Grid Biopsy Unit disposable medial BI 7: sterile; 5-pack 118979 Grid Biopsy Unit disposable lateral BI 7: sterile; 5-pack 118980 Grid Marker Block: autoclavable 111251 18G 112660 16G 112143 18G 16G Grid Needle Blocks disposable: sterile 14G 112659 12G 112731 14G 12G Breast Elevation Plate Breast BI 7 118761 10
Accessories for cranio-caudal Fixation Unit MAMMA for Breast Biopsy 7-Channel Coil BI 7 part number Cranio-caudal fixation unit BI 7: single element 118719 CC-320-Plus Cushion Breast 118193 11
Breast Biopsy 4-Channel Coil BI 4 NORAS product solutions for MAMMA Exclusively as OEM product for Siemens MRI Scanner Please contact your Siemens representative for more information The Patient Rest can be used for diagnostic imaging with the 4Ch coil and also with the optional Siemens 16Ch coil. This solution is only available through Siemens. SIEMENS 16-Channel Diagnostic Coil The NORAS Breast Biopsy 4-Channel Coil BI 4 was developed for the Siemens TIM system and serves with its 4Ch array coil for diagnostics as well as biopsy removal. The design of the whole setup is very open to ensure optimal access to the breast for interventions. Optionally, you can use the 16Ch coil for optimized imaging (spectroscopy pos- sible) with the same Patient Rest. The Breast Biopsy Kit consists of a complete Post&Pillar positioning unit and two disposable grids for medial, lateral and cranio-caudal access. The biopsy set is compatible with the coordination software from Siemens, and therefore cannot be rotated by 360°. The original accessories are exclusively avai- lable through NORAS or through authorized re-sellers. Case The Breast Biopsy Kit consists of a steam ste- rilizable fixation unit including Post&Pillar po- sitioning unit. The sterile pieces that are necessary for the bi- opsies are not part of the delivery content but can be ordered separately. Part of the biopsy kit is a 12G non-sterile trai- ning needle, including sleeve and cube, as well as two training grids (medial/CC and lateral). 12
Breast Biopsy and Fixation Unit Sets MAMMA for Breast Biopsy 4-Channel Coil BI 4 part number Breast Biopsy Set Post&Pillar: autoclavable and reusable 118941 Breast Biopsy Set Grid disposable: autoclavable and reusable; with disposable grids in sterile packaging 118943 Breast Biopsy Set Grid reusable: autoclavable and reusable 118944 Cranio-caudal Fixation Unit CC-320-PLUS 118341 Accessories for Post&Pillar Biopsy System for Breast Biopsy 4-Channel Coil BI 4 part number Post&Pillar positioning unit with telescope bar: autoclavable and reusable 111259 Post&Pillar Needle Guide: autoclavable and reusable; able to be angu- lated by 15° and 30° 111451 Post&Pillar marker: autoclavable and reusable; (remove marker liquid before autoclaving and refill afterwards) 111300 13
part number MAMMA Post&Pillar Needle Guide Breast BI 7: autoclavable 118654 Post&Pillar Marker Breast BI 7: autoclavable 118946 18G 112654 16G 112597 Post&Pillar needle guide sleeves: disposable in sterile packaging 14G 112655 12G 112653 16G 18G 14G 12G 18G 118952 16G 118953 18G 16G Post&Pillar Needle Guide Sleeves disposable BI 7: sterile; 5-pack 14G 118954 12G 118955 14G 12G Base unit fixation plate: can be used laterally, medially and cranio-cau- dally and is used as adapter for slat plates and grids 111242 Base plate 111292 Slat plate horizontal: medial and cc 111212 Slat plate horizontal: lateral 111301 C.R. Bard Vacora 118956 Post&Pillar Needle Guide Sleeves disposable BI 7: for use with MR Suros Surgical ATEC 118957 compatible Vacuum Guns; sterile; 5-pack SenoRX EnCor 10G 118958 SenoRX EnCor 7G 118950 14
part number MAMMA C.R. Bard Vacora MR10062-VAC Adapter Vacuum Guns for Post&Pillar System: Suros Surgical ATEC MR10062-AT autoclavable ; 2-pack SenoRX EnCor 10G MR10062-SE SenoRX EnCor 7G 113315 Guidance bracket for Invivo disposable needle guidance MR10062-MHA Disposable needle guidance (Multi Hub Assembly): not for 7G 113692 Adapter Vacuum Guns for Post&Pillar System Devicor Mammotome: autoclavable MR10062-ET2 Accessories for Grid Biopsy System for Breast Biopsy 4-Channel Coil BI 4 part number Grid Marker Block: autoclavable 111251 Grid biopsy unit: lateral, medial, CC; autoclavable and reusable 111252 Grid biopsy unit height adjustable: lateral; autoclavable and reusable 117143 Grid biopsy unit height adjustable: lateral; disposable in sterile packa- ging; packaging consists of 5 grids 112235 15
part number MAMMA Grid biopsy unit height adjustable: medial, CC; disposable in sterile packaging; packaging consists of 5 grids 112238 18G 112660 18G 16G 16G 112143 Grid needle blocks: disposable in sterile packaging 14G 112659 12G 112731 14G 12G Accessories for cranio-caudal Fixation Unit for Breast Biopsy 4-Channel Coil BI 4 part number Cranio-caudal fixation unit CC-320-PLUS: single element 118086 CC-320-Plus Cushion Breast 118193 16
Sterile Soft Tissue Instruments for Biopsy MAMMA ClipLoc Soft Tissue Marker system includes the ClipLoc, coaxial introducer and advancing stylet. 1.5T; 18G; 100mm MR10507 1.5T; 18G; 130mm MR10508 1.5T; 18G; 150mm MR10509 3T; 18G; 150mm 112586 Coaxial Needle coaxial needles can be used as a coaxial guide for biopsy guns; avail-able in different lenghts and gauge sizes. 3T; 12G; 111mm 112595 3T; 16G; 111mm 112596 1.5T; 12G; 61mm 112587 1.5T; 12G; 91mm 112588 1.5T; 12G; 111mm 112590 1.5T; 12G; 126mm 112589 1.5T; 14G; 61mm 112591 1.5T; 14G; 111mm 112592 1.5T; 16G; 111mm 112594 Semi-Automatic Biopsy Gun 14G; 100mm 112535 14G; 150mm 112537 18G; 100mm 112540 18G; 150mm 112541 Single/Double Hook Wire puncture needle with a localization wire; flexible material, reduces Localization Needle the risk of breakage or unwanted dislocation; available in single and double hook. Double Hook; 18G; 100mm MR24700 Double Hook; 18G; 150mm MR24701 FlexiLoc like single hook wire but repositionable in the beginning. 18G; 100mm MR24702 18G; 150mm MR24703 3T; FlexiLoc Set consisting of articles 112596 (coax needle) and MR24703 (FlexiLoc). 112585 NORAS Forceps part number MR suitable, non-magnetic forceps for the removal of tissue samp- le, 4.5“ MR00015 17
MAMMA Manual coordinate calculation for the Breast Biopsy 7-Channel Coil BI 7 On the following pages you will find instructions for the manual coordinate calculation of the BI 7 Post & Pillar and Grid Biopsy Method, which is located on the user interface of your Siemens MR-system. Besides the manual calculation of coordinates, additional solutions for software-supported coordinate calcu- lation are offered by third-party providers. Please contact NORAS or your Siemens representative directly if you have any questions regarding compatibi- lity and application. 18
Manual coordinate calculation for the Post & MAMMA Pillar Biopsy System 1 2 Perform a measurement with transversal slices and look for Start the „distance“ tool (menu, right center → „Extras“ → „di- the slice on which one you can see the marker. stance“ (ruler)). 3 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, Draw a line, straight through the pointer. the line is copied and can be pasted into other slices. 5 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. Scroll through the other slices until you find the lesion that In this example the Post & Pillar positioning unit has to be mo- you want to perform a biopsy on. Right-click on this slice und ved 31 mm from the starting position to anterior (because the select „Paste“. patient is lying in the prone position). 19
MAMMA 7 8 In order to determine the shift from head to feet (Post & Pillar positioning unit to the left or to the right), view the slice po- sition of the marker and lesion at the transversal slices. The The lesion you have chosen in step 5 is located in our example marker from step 1 is located on slice-position („SP“=Slice Po- on slice position H14.9. Hence, the difference is 14.9 mm – 0.5 sition) H0.5, therefore 0.5mm towards the head from the laser mm = 14.4 mm. In order to reach the lesion, you have to move positioning. the Post & Pillar positioning unit by 14mm towards the head. 9 10 Move the Post&Pillar unit with the marker according to the cal- culated coordinates (in our example 31mm downwards (ante- Perform a control scan in order to check that the marker is rior) and 14 mm towards the head). located in front of the lesion. 11 12 se the „distance” tool again in order to measure the pun- U cture depth from the surface of the skin to the middle of the lesion (in this case 31 mm). Subtract an offset, depending on the biopsy system (normally about 5-10 mm), in order to position the cannula lies in front of the lesion. Now puncture Perform a control scan in order to check that the end of the the breast with the trocar using this offset-corrected depth needle is positioned in front of (starting at skin surface). Afterwards pull the needle out of the lesion. the trocar and insert the plastic-bar into the cannula instead. The plastic-bar causes fewer artifacts than the needle and pre- The further biopsy may then be carried out by vents blood back-flow into the cannula. authorized personnel. 20
Angulated, manual coordinate calculation for MAMMA the Post & Pillar Biopsy System 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 angulated biopsy for any other reason, you can also work with an angulation of 15 or 30 degrees toward the top or the bottom. 13 14 ow, an angle of 15 degrees (in this example) has to be dra- N wn to the original marker line. To do so, one needs to use the tool, which you find on the right hand side under „Extras” → Draw the first line, in this example from right to left, through „Angle“. the marker toward the lesion. 15 16 The second line has to have appropriate length toward the Draw the second line with an angle of 15 degrees from right left so it lasts at least underneath the pivot point of the Post & to left. This can also be done slightly underneath the first line. Pillar marker. You can also extend that line afterwards by pul- Please be aware that in this example, where we create the ang- ling its right endpoint. The new Marker design shows the pivot le counterclockwise, we will prepare an angle of 165 degrees. point as a black cross inside the marker. 17 18 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 Choose the „distance” tool und draw a new line perpendicular endpoint in the center of the lesion. To do that, left-click the to the first line through the marker at the height of the pivot second line, hold down the left mouse key and move the line point, marked by the black cross inside the marker. It might with the mouse. help to start this line a little below the line through the marker. 21
MAMMA 19 Now move this new line, till the one ends reaches the referen- ce line through the marker and shorten it, so that is will touch the 15 degree line on the other end. You line now shows on the distance you need to move our needle guide in order to use a 15 degree angulation. In this example: 15mm up (posterior). 20 21 After movement (here 15 mm posterior) and angulation of the marker (here 15 degrees toward anterior, hence toward the After the puncture with the trocar, perform another control floor), perform a control scan in order to check that the marker scan in order to check that the end of the cannula lies right in points at the lesion. Now, determine similarly to step 11 the front of the lesion. puncture depth from the skin surface to the center of the The further biopsy may then be carried out by autho- lesion (here 30.5 mm without offset). rized personnel. 22
MAMMA Manual coordinate calculation for the Grid Biopsy System In the following the Grid localization process with medial/lateral access while using sagittal imaging slices is b riefly described. The grid pattern itself is used to locate the position of the lesion. The grid plate is mounted on the biopsy unit for the fixation of the breast. The pattern of this grid is visible on the sagittal MR-image at the edge of the breast. Therefore the grid position lying directly in line with the lesion can be identified manually. A needle block is inserted into that grid position. The lesion is marked by using the imaging tools on the scanner user interface, e.g. a circle or a cross. This marking is copied and pasted into the parallel sagittal slice, which shows the grid pattern. Now it can be easily seen, where the needle block and the needle need to be positioned. Additionally, a MR-visible marker block for better orienta- tion on the grid can be used (in this imaging example, the marker is sitting in the middle of the grid). With the knowledge of the number and thickness (plus a potential gap between slices) of the sagittal imaging slices from the surface of the grid to the lesion, the penetration depth can be easily calculated. 23
Uni-Lift Prostate Intervention Device for MR-guided interventions of the prostate Uni-Lift Prostate Intervention Device 118330 Prostate The Uni-Lift is designed as an arc in which the legs are mounted on brackets. The arc is adapted to the MR table and to the bore size, thereby preventing abutting of the legs while providing the maximum available space for intervention. The supine position allows transperineal access for biopsy and therapy of the prostate. As an application example a biopsy grid for transperineal access is shown. For MR-guided biopsies images can be taken by the specifically designed flex coil Uni-Belt or ordinary flex coils. The Uni-Lift Prostate Interventions Device from NORAS is com- Transperineal Prostate Biopsy patible to the Siemens 70 cm Bore MR Systems (Siemens MAGNE- TOM Aera 1.5T, Skyra 3T & Espree 1,5T / GE Optima 450W 1,5T & For the transperineal access, the use of reusable sterilizable Discovery 750W 3T). grids made of skin-friendly PEEK is provided. Height-adjustable grid biopsy unit for transperineal access. *NORAS is currently working on compatible solutions for other manufacturers of MR scanners. Kindly contact us in case you have any questions regarding the compatibility of the NORAS Uni-Lift Prostate Intervention Device for your scanner. 24
Uni-Belt 16-Channel Diagnostic & Intervention Coil Uni-Belt 16-Channel Diagnostics for diagnostic imaging and MR-guided interventions of and Intervention Coil 1.5T for SIE- On request MENS Scanner the prostate and other internal organs INTERVEN- in development TION The flexible 120 cm (47.24 in) long and 32 cm (12.6 in) wide coil is designed so that it can wrap around both hips, ab- domen and chest. The coil size is designed for optimal penetration depth to the body center. Due to a fixation system using two belts, the coil can be positi- oned very close and stable to the desired anatomy. The coil is designed for diagnostic images of the pro- state or internal organs (liver, kidney, etc), as well as MR-guided interventions, which can be performed th- rough integrated biopsy windows inside the coil plane. A biopsy unit with angulation possibility was specifically developed for the Uni-Belt coil. It can be easily attached inside the coils’ biopsy windows. Biopsies of prostate, liver, kidney, spinal cord etc. can be performed through the steam sterilizable and reusable biopsy unit made out of PEEK material. The NORAS Uni-Belt 16-Channel Diagnostic & Intervention Coil achieved in direct comparison a significantly higher SNR. The ana- lysis shows an improvement of 37% to 70%. This is also confirmed in the in vivo imaging. The advantage of the NORAS Uni-Belt is given by the arrangement of its single elements combined with the complete covering of the examination area. Futhermore, a better adapting to the anatomy has positive effects on the result of measurement. Left: NORAS Uni-Belt 16-Ch Diagnostic & Intervention Coil Left: NORAS Uni-Belt 16-Ch Diagnostic & Intervention Coil Right: 2x Siemens Body Matrix 6 channel flex coil Right: 2x Siemens Body Matrix 6 channel flex coi 25
Variety 16-Channel Multipurpose Coil 1.5T & 3T The Variety 16-Channel Multipurpose Coil enables high-resolution MR imaging in orthope- dics and pediatrics. Variety 16-Channel Multipurpose Coil 1.5T 117235 Variety 16-Channel Multipurpose Coil 3T 117234 Variety long 16-Channel Multipurpose Coil 3T On request The „Variety“ Coil is a 16-channel multipurpose array, which has been developed for high flexibility during examination of challenging anatomic regions. A good example for such areas is the imaging of musculoskeletal areas. VARIETY High signal quality based on a design with 8+8 array elements with high coil element density High resolution examinations of even small body regions with reduced scan durations High speed image acquisition due to the possibility of accele- rated imaging in all directions Application for diagnosis in orthopedics, pediatrics and in veterinary medicine Enables motion studies of all joints Enables mounting very close to anatomical region of interest through dedicated positioning aids (optimal image quality) • Compatibility with Siemens coil portfolio NEW: Siemens Coil File available* • No need to remove the spine coil anymore * Only applies for Siemens Skyra 3T and Aera 1.5T customers Each half of the coil is based on an 8-channel array, which can be used separately as a surface array for coverage of various body areas. The indivi- dual coil elements in each array have a small diameter of approximately 7 cm. This design results in a high signal quality, which allows for highest achievable resolutions. Based on the high mechanical FLEXIBILITY and on the small size of its array elements the “Variety“ covers a much larger field of applications for high resolution imaging in comparison to standard flexcoils. Through the use of Velcro® strips and dedicated positioning aids the “Variety“ Array can be adjusted very well to curved anatomical regions. The Variety 16-Channel Multipurpose Coil from NORAS MRI products is compatible to all Siemens Tim® systems. NORAS is currently working on compatible solutions for other manufacturers of MR-scanners. Kindly contact us in case you have any questions regarding the compatibility of the NORAS 16-Channel Multipurpose Array for your scanner. 26
Typical Applications and Positioning Aids - Orthopedics The 16 channels of the compact Variety Array Coil are specially designed to enable a deeper penetration of tissue with a larger field of view. Hand and Wrist VARIETY The size of the coil halves enables imaging of the whole hand and wrist. A special positioning aid, in which the bottom coil half can be placed, creates a sta- ble and flat surface to put the hand on. If needed, the second coil half can be put on top of the hand. Alternatively, the hand can be positioned “standing up“ using our elbow positio- ning aid (see illustration below right). Elbow For smaller elbows (e.g. kids) a single coil half can be used to be wrapped around the elbow. This coil half can then be fixated using Velcro® strips. For bigger elbows, the size adjustable positioning aid can be used. 27
Shoulder A special sloped positioning device allows comfortable support on the lower coil half. For fixation of the upper coil half, you can use e.g. sandbags. VARIETY Knee, Foot and Ankle The stageless adjustment of the positioning device allows for proper support of pa- tients with a body size of up to 2.1 m and for knees with high or low volume. The flexible design also allows imaging in flexed and stretched position. Further- more, an optional supporting element for imaging in flexed position is available. We advise to use always the positioning aids in combination to enable support and less motion of the patient. 28
Typical Applications and Positioning Aids - Pediatrics Pediatrics small (0 - 6 months) VARIETY Pediatrics medium (6 - 36 months) Pediatrics large (4 - 8 years) 29
VARIETY Hand at 3T (Siemens Skyra) Hand at 3T (Siemens Skyra) Wrist at 3T (Siemens Skyra) Sequence parameters: 0.34 x 0.34 x 2 mm³; Sequence parameters: 0.29 x 0.29 x 1.5 mm³; Sequence parameters: 0.23 x 0.23 x 3 mm³; TR=3000ms; TE=58ms; TA=2:21; TR=34ms; TE=20ms; TA=2:44; TR=600ms; TE=14ms; TA=1:47; PAT-Factor: 2; FOV: 220 x 220. PAT-Factor: 3; FOV: 220 x 220. PAT-Factor: 2; FOV: 90 x 90. Shoulder at 3T (Siemens Skyra) Shoulder at 3T (Siemens Skyra) Knee at 3T (Siemens Skyra) Sequence parameters: 0.36 x 0.36 x 3 mm³; Sequence parameters: 0.41 x 0.41 x 3.2 mm³; Sequence parameters: 0.36 x 0.36 x 2.5 TR=600ms; TE=24ms; TA=3:34 min; TR=2500ms; TE=34ms; TA=2:40 min; mm³; TR=525ms; TE=11ms; TA=2:26 min; PAT-Factor: 2; FOV: 160 x 160. PAT-Factor: 2; FOV: 150 x 150. FOV: 150 x 150. Hip at 3T (Siemens Skyra) Hip at 3T (Siemens Skyra) Jaw joint at 3T (Siemens Skyra) Sequence parameters: 0.46 x 0.46 x 2 mm³; Sequence parameters: 0.43 x 0.43 x 1.2 mm³; Sequence parameters: 0.23 x 0.23 x 2 mm³; TR=600ms; TE=11ms; TA=3:48 min; TR=12.6ms; TE=5.1ms; TA=4:50 min; TR=3000ms; TE=95ms; TA=1:42 min; FOV: 119 x 119. PAT-Factor: 3; FOV: 199 x 220. FOV: 120 x 120. 30
VARIETY Elbow at 3T (Siemens Skyra) Elbow at 3T (Siemens Skyra) Foot at 3T (Siemens Skyra) Sequence parameters: 0.5 x 0.5 x 2 mm³; Sequence parameters: 0.6 x 0.6 x 3 mm³; Sequence parameters: 0.31 x 0.31 x 2 mm³; TR=729ms; TE=10ms; TA=2:54 min; TR=3000ms; TE=41ms; TA=4:33; TR=650ms; TE=11ms; TA=2:01 min; FOV: 89 x 260. PAT-Factor: 2; FOV: 200 x 200. PAT-Factor: 2; FOV: 120 x 120. Knee at 3T (Siemens Skyra) Ankle at 3T (Siemens Skyra) Ankle at 3T (Siemens Skyra) Sequence parameters: 0.31 x 0.31 x 3 mm³; Sequence parameters: 0.33 x 0.33 x 2 mm³; Sequence parameters: 0.39 x 0.39 x 3 mm³; TR=2500ms; TE=24ms; TA=2:27 min; TR=31ms; TE=18ms; TA=2:53 min; TR=3100ms; TE=34ms; TA=2:47 min; PAT-Factor: 2; FOV: 140 x 140. PAT-Factor: 3; FOV: 150 x 150. PAT-Factor: 2; FOV: 150 x 150. Child at 3T (Siemens Skyra) Child at 3T (Siemens Skyra) Child at 3T (Siemens Skyra) Sequence parameters: 0.35 x 0.35 x 4 mm³; Sequence parameters: 0.31 x 0.31 x 3.5 mm³; Sequence parameters: 0.34 x 0.34 x 3 mm³; TR=2410ms; TE=95ms; TA=5:39 min; TR=600ms; TE=20ms; TA=5:46 min; TR=633ms; TE=23ms; TA=7:32 min; PAT-Factor: 2; FOV: 181 x 223. PAT-Factor: 2; FOV: 181 x 200. PAT-Factor: 2; FOV: 165 x 220. 31
Technical Specifications Coverage Wrap Diameter Variety 16-Channel Multipurpose Coil (one coil half) 20 cm x 22 cm 5.5-8 cm VARIETY Variety 16-Channel Multipurpose Coil (both coil halves) 20 cm x 44 cm 11-17 cm Available Coil Packages part number Variety 16-Channel Multipurpose Coil 1.5T, Cable Length: 100 cm • Variety 16-Channel Multipurpose Coil 1.5T 2 pc. • Variety Clip 2 pc. 117235 • Variety Positioning Aid Multipurpose 2 pc. • Velcro® Fastener 300 4 pc. • Velcro® Fastener 500 4 pc. • Velcro® Fastener 500 back-to-back 4 pc. Variety 16-Channel Multipurpose Coil 3T, Cable Length: 100 cm • Variety 16-Channel Multipurpose Coil 3T 2 pc. • Variety Clip 2 pc. 117234 • Variety Positioning Aid Multipurpose 2 pc. • Velcro® Fastener 300 4 pc. • Velcro® Fastener 500 4 pc. • Velcro® Fastener 500 back-to-back 4 pc. Variety lang 6-Channel Multipurpose Coil 3T, In development Cable Length: 150 cm • Variety lang 16-Channel Multipurpose Coil 3T 2 pc. • Variety Clip 2 pc. On request • Variety Positioning Aid Multipurpose 2 pc. • Velcro® Fastener 300 4 pc. • Velcro® Fastener 500 4 pc. • Velcro® Fastener 500 back-to-back 4 pc 32
Accessories for the Variety 16-Channel Multipurpose Coil part number Variety Positioning Aid Set Orthopedics 118353 (incl. Positioning Aids Elbow, Shoulder and Knee/Foot/Ankle) Variety Positioning Aid Set Pediatrics 118354 (incl. Positioning Aids Pediatrics small, medium and large) VARIETY Variety Positioning Aid Multipurpose 118398 Variety Positioning Aid Elbow 118468 Variety Positioning Aid Shoulder 118413 Variety Positioning Aid Knee, Foot and Ankle 118463 Variety Positioning Aid Pediatrics small 118465 Variety Positioning Aid Pediatrics medium 118467 Variety Positioning Aid Pediatrics large 118412 Variety Positioning Aid Inlay 118415 Variety Lagerungshilfe Pädiatrie Kopf 118417 33
Mandibula 15-Channel Dental Coil Mandibula 15-Channel Dental Coil 1,5T for SIEMENS Scanner on request High-Resolution Imaging for Diagnostics in Orthodontics Mandibula 15-Channel Dental Coil 3T for SIEMENS Scanner 118871 Our Mandibula 15-Channel Dental Coil is a multi-element receive array and positioning system for three-dimensional (3D) high-resolution dental and maxillomandibular MRI images. Also it ensures maximum patient comfort due to its design and accessories like a patient rest pillow, an open-mouth fixation mechanism and a both direction mirror. Typical applications: • Orthodontia (instead of x-ray) • Diagnostics of the jaw joint DENTAL • Imaging of periodontium and dental pulp • Implantology • Imaging of nerves (foramen mentale) • Bone density (compacta, spongiosa) • Forensics (age estimation through wisdom tooth) • Maxifacially imaging (e.g. search for tumors) • Larynx • Inflammation Transversal view Advantages: High resolution dedicated MR imaging in dental area Highest resolution movement studies of the jaw joint Coil element underneath chin can be moved in and out for motion studies, e.g. on the jaw joint Easy to position and adjustable for each patient Excellent patient comfortability (especially for children during exami- nation) Reduced scan times with higher image quality as compared to stan- dard coils Optional mirror attachable for claustrophobic patients Minimized unwanted signal distortions (vibration, movement etc.) Sagittal view Panoramic teeth view 34
Intraoperative Neuro- surgery solution from NORAS As early as 2005, NORAS MRI products GmbH presented the first MR compatible head holder with receiving coils and was thus the pioneer in the field of intraoperative MRI imaging in the field of neurosurgery. With the innovative head holder NORAS was able to quickly establish a leading position in Neuro neurosurgery solutions. Based on a creative and respectful cooperation with leading neurosurgeons from Germany, Switzerland, the US and Ca- nada NORAS has created the improved head holders FLEXI- BILITY and HEIDBERG in 2013. Developed in close cooperation, the head holder HEIDBERG became a strong alternative to older versions of NORAS head holders. Both head holder systems convince besides excellent image quality with a unique sterile concept and an optimized workflow. The significant developments are based on requirements, ideas and challenges that leading neurosurgeons experien- ce in their everyday work. The increased reliability and high availability of the Head Holders FLEXIBILITY and HEIDBERG are proven in e.g. yearly more than 200 successfully completed cases in Europe using these advanced systems for MR-based neurosurgery. Thanks to ongoing enhancements and innovations, NORAS belongs to the drivers of intraoperative MR imaging. This was proven again in 2018: The new LUCY head holder combines the outstanding attributes of years of experien- ce in the field of MRI with new applications thanks to its CT compatibility. With constant improvements and new de- velopments the NORAS MRI products Ltd is a reliable part- ner for MR-supported neurosurgery. 35
OR Head Holder LUCY & OR Head Coil 1.5T / 3T MR- and X-Ray compatible for multimodal applications for Siemens Magnetom Aera 1.5T & Skyra 3T/ Maquet MAGNUS OR Table & Alphamaquet Plus * LUCY is an innovative neurosurgery solution that combines the functions of a head holder for secure fixation of the skull during interventions and a MR coil for intra-operative imaging. The head holder is compatible with the established 8-channel NORAS head coil setup. Thanks to the radiotranslucent material, the OR Head Holder LUCY (without the NORAS OR Head Coils) can also be used in the X-ray environment – CT and angiogra- phie – for intra-operative imaging. Besides tumor resections, “deep brain stimulations” (DBS) and minimally invasive pituitary surgery, the system also supports awake craniotomies. The NORAS OR Head Holder LUCY and the NORAS OR Head Coil 1.5T / 3T can be used with the MR systems Siemens Magnetom Neuro Aera / Skyra together with the Combi Dockable Table. Due to the compatibility to the new transferboard from Maquet our solution can be combined with nexaris Angio-MR-CT, the Artis pheno Angiography System and with the Somatom CT Sliding Gantry Systems. * NORAS is currently working on compatibility solutions for other MRI scanner and surgical table manufacturers. Please contact us if you have any questions about the compatibility of the OR head holder LUCY and the head coil of NORAS. The design provides a comfortable positioning of the patient in prone, supine or lateral position on the OR table. The head frame of the NORAS OR Head Holder allows exact adaptation to the patient‘s head size. For optimal access to the area of intervention, the head frame can be pivoted, rotated, tilted and adjusted in height. A secure attachment of the patient‘s head is ensured by the three-point fixation. With the help of the integrated force indicator, the required clamping force can be checked exactly. The entire system is height-adjustable to achieve optimal patient positioning in 70 cm bores (Siemens Magnetom Aera & Skyra) as well as in Siemens CT scanners. In addition, the entire structure can be moved along the head-foot-axis and the horizontal axis. The NORAS 2x4 Ch coil concept, with the ability to position the both coils close to the head, provides excellent image quality. The OR Head Holder LUCY can be used in combination with nexaris Angio-MR-CT, Artis pheno Angiography System and Somatom CT Sliding Gantry Systems. LUCY is compatible with various surgical equipment (e.g. GREENBERG™, VarioGuide™, LEYLA retractors) and supports the navigation system of Brainlab. Thanks to a unique sterile concept, neither cables nor coils need to be sterilized! 36
Overview Collision check with bore gauge Brainlab AIR Support Excellent access to the Optional accessories intervention area Flexible patient positioning No sterilization of the coils and cables neces- sary Neuro 8-channel coil setup 1.5T / 3T Integrated force indicator 3-point fixation Radiotranslucent Removable and height material adjustable lower coil element 37
8-Channel Coil setup 1.5T / 3T Coil system Achieve maximum image quality and perfectly homo- geneous illumination with the NORAS 8-Channel Coil system! The two-part construction of the coil system allows the removal of the coil halves in the preparation phase and during the intervention, which allows excellent access to the ROI (region of interest). The lower coil can be placed close to the patient‘s head due to the height adjustment possibility! Neuro height adjustable lower coil Sterile workspace: protection Sterile concept and time saving Thanks to a unique sterile concept, neither cables nor coils need to be sterilized! The sterile work area is delimited with two surgical di- sposable drapes. Thus, coils and cables as well as most of the components of the head-holder can be used in a non-sterile environment. The newly designed clamping mechanism ensures easy handling for optimum surgical drape protection! 38
3-point fixation with integra- Fixation ted force indicator Choose the right clamping force for a secure position of the patient‘s head! The integrated force indicator on the rear end of the one-point fixation allows you to precisely control the tension before and during the procedure. Optional Accessories for NORAS OR Head Holder LUCY Neuro part number All Purpose Arch Set LUCY: The All Purpose Arch can be attached in different angles to the toothing of the clamps in head-foot direction. If mounted in foot direction, the scalp can be sewed onto the arch or 119672 mounted with rubber bands or hooks. If mounted in the front, the arch serves as a hand rest. Additionally GREENBERG™ retractors can be mounted onto the arch by using various GREENBERG™ retractors. VarioGuide™ Adapter LUCY: With this adapter, the BrainLab VarioGui- de™ Biopsy Arm can be mounted on the left or right side of the Head 119671 Holder. GREENBERG™ Retractor Adapter: This additional adapter can be atta- ched to the All Purpose Arch and serves as an adapter of several GREEN- BERG™ and Budde® Halo retractors. It can be flexibly mounted on the 114295 All Purpose Arch. Leyla Retractor Socket: The socket serves as mount of the various LEYLA® Retractors. The top part can be rotated horizontally in various angles. The bottom part is inserted into the dove tail of the Clamps (p/n 113243 11937) or of the GREENBERG™ Retractor Adapter and locked tightly. 39
OR Head Holder FLEXIBILITY & OR Head Coil 1.5T / 3T established Neurosurgery Solution for interventional MRI for Siemens Magnetom Aera 1.5T & Skyra 3T/ Philips Ingenia 1.5T &3T/ Maquet Magnus OR Table & Alphamaquet Plus / Trumpf -TruSystem 7500 Neuro FLEXIBILITY is an established Neurosurgery Solution for interventional MRI. The head holder ensures safe immobilization of the head during an open skull surgery while also supporting the NORAS OR head coil system, already convinced with its excellent image quality. The Head Holder & OR Head Coils are available for Siemens and Philips 1.5T and 3T MR systems. The NORAS OR Head Holder FLEXIBILITY allows supine, prone, lateral positioning of the patient and supports awake cra- niotomies, DBS and minimally invasive pituitary surgery FLEXIBILITY is is also suitable for pediatric applications. The Head Holder is designed as a three-point fixation in the lateral level. Furthermore, the surgeon has the option of using up to seven fixation points. For optimum access to the area of intervention, the head frame can be tilted, swiveled and rotated. The NORAS OR Head Holder FLEXIBILITY is height-adjustable, which enables excellent patient positioning in 70 cm bore systems Philips Ingenia and Siemens MAGNETOM Aera & Skyra. There is the possibility to move the setup along the head-feet-direction, which is very convenient when positioning the patient on the OR table. The NORAS OR Head Coils provide very good field homogeneity and excellent image quality. The OR Head Holder FLEXIBILITY is easy to clean. Furthermore, none of the cables nor any of the coils needs to be steri- lized. The Head Holder is compatible to various operating tools (e.g. GREENBERG™, VarioGuide™, LEYLA-Retractors) and sup- ports the navigation systems of Brainlab and Medtronic. 40
Brainlab AIR Support Overview Optional accessories Fixation with up to No sterilization seven points possible of the coils and cables necessary 8-channel coil setup 1.5T / 3T Removable lower coil element Flexible patient positioning Neuro NORAS MRI products has developed a “Sterile Concept” The sterile area is located between the two dra- Sterile Concept for the NORAS OR Head Holder and Head Coils. This was pes. Just the lower drape, in the picture turquoi- done in cooperation with the Neurosurgical University se, is getting perforated (the screws of the clamps Hospital of the University Clinical Center Heidelberg, penetrate the lower drape). The second drape, in the Neurosurgical Clinic of the University of Ulm at the picture violet, is not being penetrated at all. BKH Guenzburg and the Neurosurgery Center of the The coils and cables can stay non-sterile. ASKLEPIOS Clinic North – Hamburg/Heidberg. Due to this concept, there is no need to sterilize the co- ils and cables. During the development process, NORAS emphasized that the coils and cables as well as most components of the Head Holder can be used in an unsterile environ- ment. The basic concept is to create a sterile chamber in between the patient’s head and the top coil with two sterile OR drapes. A compatible version of the reference star and head holder adapter has been developed in collaboration with BrainLab AG. The reference star can now be tightly attached to the head holder without perforating the sterile OR drapes. This sterile concept is offered to all existing customers as an upgrade kit HEIDBERG. Left: Setup with All Purpose Arch, Multifunctional Bar System, VarioGuide™ Adapter and BrainLab Drape Link Reference Star. Right: Setup with two All Purpose Archs, VarioGui- de™ Adapter and BrainLab Drape Link Reference Star. 41
Flexible Pinning Possibilities Fixation Concept There are now three mounting points for height-adjus- table bottom pins. For the upper pins, a combination of one 2-point fixation and a 1-point fixation or two 2-point fixations can be mounted on each side of the head frame. This enables flexible pinning combinations in consideration of all patient positioning options. Clamping Device with Force Indicator The Clamping Device with Force Indicator allows the surgeon to apply a defined pinning force during fixati- on of the patient‘s head. Once the desired force is rea- ched, the fixation rod is tightened up by a lock lever and the clamping device can be removed. Neuro NORAS OR Head Holder FLEXIBILITY in the application 42
OR Head Holder HEIDBERG & OR Head Coil 1.5T / 3T Upgrade-Kit for our existing customers The Head Holder HEIDBERG is a further development of the older NORAS OR Head Holder versions for our existing customers. With the improved HEIDBERG model, several product features of our es- tablished neurosurgery solution FLEXIBILITY are available. The head holder ensures a secure stabilization of the head during the neurosurgical interventions. Thanks to the NORAS 8-channel OR Head Coils, excellent image quality can be achieved. We recommend all customers and users of older NORAS Head Holder versions – SI7000, SI7000-MQ, SI7300 or 113056 or 113066 (version 4) – to upgrade their systems with the HEIDBERG upgrade kit. The NORAS OR Head Holder HEIDBERG allows fFlexible and comfortable patient positioning and supports awake cranio- tomies, DBS and minimally invasive pituitary surgery. The OR Head Holder is suitable for use in pediatrics. The Head Holder is designed as a three-point fixation in the lateral level. Furthermore, the surgeon has the option of using up to seven fixation points. For optimum access to the area of intervention, the head frame can be swiveled and rotated. The NORAS OR Head Coils provide very good field homogeneity and excellent image quality. The OR Head Holder HEIDBERG is easy to clean. Furthermore, none of the cables nor any of the coils needs to be sterili- zed. The Head Holder is compatible to various operating tools (e.g. GREENBERG™, VarioGuide™, LEYLA-Retractors) and sup- ports the navigation systems of Brainlab and Medtronic. 43
Optional Accessories for OR Head Holder FLEXIBILITY and Upgrade Kit HEIDBERG part number Multifunctional Bar System: Through the modular setup of toothed joint parts and bars, the bar system can be adjusted ideally. GREEN- BERG™ retractors can be mounted onto the bars and Budde® Halo re- tractors can be clamped onto the joint parts. The ending of the joint 113217 parts is composed of a LEYLA Retractor Socket, which can be turned and locked vertically in various angles. VarioGuide™ Adapter: With this adapter, the BrainLab VarioGuide™ 111815 Biopsy Arm can be mounted on the left or right side of the Head Holder. Neuro All Purpose Arch: The All Purpose Arch can be attached in different angles to the toothing of the clamps in head-foot direction. If mounted in foot direction, the scalp can be sewed onto the arch or 113220 mounted with rubber bands or hooks. If mounted in the front, the arch serves as a hand rest. Additionally GREENBERG™ retractors can be mounted onto the arch by using various GREENBERG™ retractors. GREENBERG™ Retractor Adapter: This additional adapter can be atta- ched to the All Purpose Arch and serves as an adapter of several GREEN- 114295 BERG™ and Budde® Halo retractors. It can be flexibly mounted on the All Purpose Arch. LEYLA Retractor Socket: The socket serves as mount of the various LEYLA® Retractors. The top part can be rotated horizontally in various angles. The bottom part is inserted into the dove tail of the Clamps (p/n 113243 11937) or of the GREENBERG™ Retractor Adapter and locked tightly. Pediatric Set: The Pediatric Set has been developed in order to fulfill the requirements of pediatric demands. It includes a vacuum cushion, which effectively supports the child‘s head. Another component is a fixation force gauge with a hysteresis free cera- 114804 mic spring, which provides accuracy between 0N to 60N. A set of 6 tita- nium pins with small tips is included. 44
Historical Overview Development of the Noras OR Head Holder Head Holder SI7000 // Head Holder SI7000-MQ for Trumpf Miyabi Shell for Maquet bearing 1180-71A0 and 6042-01C0 The NORAS Head Holder SI7000 has been developed for the use with the Trumpf OR table Jupiter in combination with the Siemens Neuro Miyabi Shell for Siemens 1.5T and 3T MR systems (Espree, Symphony, Avanto, Verio, Trio). The NORAS Head Holder SI7000-MQ has been developed for the use with the Maquet bearing 1180-71A0 and 6042-01C0 for Philips Achieva 1.5T and 3T MR systems. Neuro Head Holder SI7300 For Siemens Magnetom Espree, Symphony and Verio with Rotating Table The NORAS Head Holder SI7300 has been exclusively developed for the Siemens MAGNETOM systems with rotating table. This combination allows lateral left or right patient positioning. Numerous variations of surgeries are possible, e.g. awake craniotomies in lateral position are feasible. Besides the standard accessories, further special accessories are available for the SI7300. 45
Historical Overview Head Holder 113056 // Head Holder 113066 (Version 4) for Trumpf Miyabi Shell for Maquet bearing 1180-71A0 and 6042-01C0 The NORAS Head Holder 113056 has been developed for the use with the Trumpf OR table Jupiter in combination with the Siemens Neuro Miyabi Shell for Siemens 1.5T and 3T MR systems (Espree, Symphony, Avanto, Verio, Trio). The NORAS Head Holder 113066 has been developed for use with the Maquet bearing 1180-71A0 and 6042-01C0 for Philips Achieva 1.5T and 3T MR systems. In contrast to the previous Head Holders SI7000 and SI7000-MQ, a new sterile concept has been realized. During the development process, NORAS emphasized that the coils and cables as well as most components of the Head Holder can be used in an unsterile environment. The basic concept is to create a sterile chamber in between the patient’s head and the top coil with two sterile OR drapes. For this reason, only one top array coil is required. Furthermore, the bottom array coil can now be removed for better access during the intervention. Neuro Locations of the NORAS Head Holder worldwide This map shows the locations of existing clients of our neurosurgery-solutions allover the world (Status July 2018). 46
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