Product Information 2020 - English - NORAS MRI products

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Product Information 2020 - English - NORAS MRI products
Product Information 2020
English
Product Information 2020 - English - NORAS MRI products
Technical changes reserved

113238

Issue EN
Rev02
October 2019

2
Product Information 2020 - English - NORAS MRI products
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
Product Information 2020 - English - NORAS MRI products
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
Product Information 2020 - English - NORAS MRI products
in summary
MaMMA DIAGNOSTICS AND BIOPSY
Biopsy Methods .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .  6
Cranio-caudal Fixation Units .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .  7
Breast BI 7 MR Coil Set 1.5T & 3T .                                                      .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .                                                      8
                     Breat Biopsy and Fixation Unit Sets  .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   . 9
                     Optional Components for Post&Pillar Biopsy System .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .  9
                     Optional Components for Grid Biopsy System  .                                                                                  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .                                           10
                     Optional Components for cranio-caudal Fixation Unit .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .  11
Breast Biopsy 4-Channel Coil BI 4  .                                                         .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .                                                     12
                     Breast Biopsy and Fixation Unit Sets  .                                                              .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .                                                13
                     Optional Components for Post&Pillar Biopsy System  .                                                                                             .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .                                        13
                     Optional Components for Grid Biopsy System  .                                                                                  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .                                           15
                     Optional Components for cranio-caudal Fixation Unit .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .  16
Sterile Soft Tissue Instruments for Biopsy .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .  17
Manual coordinate calculation for the Breast BI 7 MR Coil Set .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .  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
                     Optional Components 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 Components 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 Components 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  .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .  67
NORAS Certificates .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .   .  68

                                                                                                                                                                                                                                                                                                                                                                                                   5
Product Information 2020 - English - NORAS MRI products
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

                                                                                                                                   High accuracy due to accurate coordinate
                                                                                                                               4   adjustment
                                                                                                                      o il B I
                                                                                For Breast Biopsy 4 - C    ha nn e l C
                                                                                                                                   Angular needle guidance 15 ° and 30 ° pos-
                                                                                                                                   terior and anterior

                                                                                                                                   Sterile disposable needle guide sleeves are
                                                                                                                                   available*

                                        For Breast BI 7 MR Coil Set                                                                                         * distributed by NORAS
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*

                                                  For Breast BI 7 MR Coil Set                                                                               * distributed by NORAS

                           Both methods are compatible with the following Vacuum Guns:

                           C.R. Bard Vacora™                    Suros Surgical ATEC™                              Devicor Mammotome™                 SenoRX Encor MRI™

                           6
Product Information 2020 - English - NORAS MRI products
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

                                                                                                                                                    ilS et
                                                                                                                                                 Co

                                                                                                                                                  R
                                                                                                                                       I   7M
                                                                                                                          For Breast B

                                                                                                                                                                 7
Product Information 2020 - English - NORAS MRI products
Breast BI 7 MR Coil Set 1.5T & 3T                                                                       NORAS product solutions for
MAMMA

        Exclusively for the new Siemens MRI scanner generation
        Vida and Sola
                                                                                                                Please contact your Siemens
        The Noras Breast BI 7 MR Coil Set 1.5T & 3T is an innovative solution designed to                       ­representative for more information
        offer flexible use to meet the needs of the procedure to be performed in your
        clinic.
        Using the same set of comfort cushions, it can be combined with the Breast 18
                                                                                                                You can obtain all components
        imaging coil from Siemens.
        The rigid coil frame forms a high element-density, 7-channel „phased array” con-                        Breast Biopsy and Fixation Unit di-
        figuration for high resolution imaging. One sided medial and up to two-sided                            rectly from NORAS. We will be plea-
        lateral biopsy access is possible.                                                                      sed 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.
                                                                                                                                            * distributed by 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
Product Information 2020 - English - NORAS MRI products
Breat Biopsy and Fixation Unit Sets

                                                                              MAMMA
for Breast BI 7 MR Coil Set 1.5T & 3T                       part number

Breast Biopsy Set for Breast BI 7                           on request

Cranio-caudal fixation Breast BI 7                          on request

Optional Components for Post&Pillar Biopsy System
for Breast BI 7 MR Coil Set 1.5T & 3T
                                                            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

Horizontal Slat Plate Breast BI 7 medial: autoclavable      118649

Horizontal Slat Plate Breast BI 7 lateral: autoclavable     118622

                                                                          9
Product Information 2020 - English - NORAS MRI products
part number
MAMMA

                                                                             18G 118952
                                                                             16G 118953                     18G   16G
        Post&Pillar Needle Guide Sleeves disposable BI 7*: sterile; 5-pack
                                                                             14G 118954
                                                                             12G 118955
        * distributed by NORAS                                                                              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
        * distributed by NORAS
                                                                             SenoRX EnCor 7G    118950

        Optional Components for Grid Biopsy System
        for Breast BI 7 MR Coil Set 1.5T & 3T
                                                                             part number

         Grid Biopsy unit disposable medial BI 7*: sterile; 5-pack           118979
        * distributed by NORAS

         Grid Biopsy unit disposable lateral BI 7*: sterile; 5-pack          118980
         * distributed by NORAS

         Grid Marker Block: autoclavable                                     111251

                                                                             18G 112660
                                                                             16G 112143                     18G   16G
         Grid Needle Blocks disposable*: sterile
                                                                             14G 112659
                                                                             12G 112731
        * distributed by NORAS                                                                              14G   12G

         Breast Elevation Plate Breast BI 7                                  118761

        10
Optional Components for cranio-caudal Fixation Unit

                                                                      MAMMA
for Breast BI 7 MR Coil Set 1.5T & 3T
                                                   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 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.
                                                                                                          * distribution via Siemens Healthineers

                                                                       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°.
                                                                                                                          * distributed by NORAS

                                                                                             The original components are exclusively
                                                                                             available through NORAS or through autho-
                                                                                             rized 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
                  biopsies 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).

                                              * distributed by NORAS

        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

* distributed by NORAS

Breast Biopsy Set Grid reusable: autoclavable and reusable              118944

Cranio-caudal Fixation Unit CC-320-PLUS                                 118341

Optional Components 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
        * distributed by NORAS                                                                                   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
        * distributed by NORAS                                                                                     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
        * distributed by NORAS

        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

Optional Components 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
packaging; packaging consists of 5 grids                                 112235
* distributed by NORAS

                                                                                                             15
part number
MAMMA

        Grid biopsy unit height adjustable*: medial, CC; disposable in sterile
        packaging; packaging consists of 5 grids                                 112238
        * distributed by NORAS

                                                                                 18G 112660
                                                                                               18G   16G
                                                                                 16G 112143
        Grid needle blocks*: disposable in sterile packaging
                                                                                 14G 112659
                                                                                 12G 112731    14G   12G
        * distributed by NORAS

        Optional Components 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; 111mm                   112592
1.5T; 16G; 111mm                   112594

Semi-Automatic Biopsy Gun*
14G; 100mm                         112535
14G; 150mm                         112537
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
                                                                                                           * distributed by NORAS

NORAS Forceps                                                            part number

MR suitable, non-magnetic forceps* for the removal of tissue samp-
le, 4.5“                                                                 MR00015
* distributed by NORAS

                                                                                                                              17
MAMMA

             Manual coordinate calculation for the Breast
             BI 7 MR Coil Set
             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 compa-   Transperineal Prostate Biopsy
           tible to the 70 cm Bore MR Systems (Siemens MAGNETOM Aera
           1.5T, Skyra 3T & Espree 1,5T / GE Optima 450W 1.5T & Discovery    For the transperineal access, the use of reusable sterilizable
           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 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.

                                                                                                                                     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      119722

          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 deep pe-
netration of tissue with a large 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,
           Cable Length: 150 cm
           ­­
              • Variety lang 16-Channel Multipurpose Coil 3T   2 pc.
              • Variety Clip                                   2 pc.   119722
              • 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
Optional Components 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 *

                                                                                                                FDA: Pending
                                                                                   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.
Neuro

                                                                                   The NORAS OR Head Holder LUCY and the NORAS OR Head Coil
                                                                                   1.5T / 3T can be used with the MR systems Siemens Magnetom
                                                                                   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
                                                                                  Optional components

            Excellent access to the
            intervention area

                                                                                          Flexible patient
                                                                                              positioning

            No sterilization of the
            coils and cables neces-

                                                                                                             Neuro
            sary

                                                                           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 Components 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 intraoperative 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 intraoperative 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.

                                 Due to a proven sterile concept, there is no need to sterilize the coils and cables.

                                 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

                                                               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 flexible and comfortable patient positioning and supports awake cranioto-
                 mies, 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 Components 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 components, further special components 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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