TORNIER. scan protocol V2.1. Tornier Upper Extremities

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TORNIER TM scan protocol V2.1 Tornier Upper Extremities

Contents 4 Introduction 4 Patient Preparation 4 Scanning Instructions 5 Image Instructions 6 Scanning Parameters 7 Technical Instructions

Scan Protocol Introduction This document describes the guidelines for a Shoulder CT-Scan to be processed by Blueprint tm 3D Planning Software. Optimize the likelihood of successful scan reconstruction in BLUEPRINT 3D Planning Software. Note : Please contact the helpline if you require further information. Figure 1: Artifacts generated by metallic implants Patient Preparation» Verify that metal is not present within the scanned portion of the operative side (Figure 1) Note: Pacemakers, dental and cervical hardware can cause artifact if too close to the Gleno Humeral joint. If artifact too intense, do not scan.» Do NOT use contrast material Figure 2: Position of the patient in the machine» place the patient supine on the scanner table, Humerus along the trunk (Figure 2) Note: Position must be craniocaudal oriented (head first) and iso-centered, with the hand in a neutral position.» It is strongly recommended to place a sponge or a small pillow between Humerus and trunk Scanning Instructions» No gantry tilt» Limit the field of view to the desired/operative shoulder Figure 3: Example of incomplete projections» Avoid incomplete projections of soft-tissue wrap by having all shoulder soft-tissue within the field of view (causes pseudo-metal artifact) (Figure 3)» It is strongly recommended to perform a full scan of Scapula bone (Figure 4)» All slices must have the same field of view, and the same slice spacing» Do NOT use auto-ma setting Figure 4: Full scan of the scapula 4 Blueprint tm 3D Planning Software - v2.1 Scan protocol

Images Instructions» use only axial images, no other reconstructions or reformations in different planes (sagittal or coronal)» The DICOM file format is defined in the Transfer Syntax (0002, 0010) Tag field, the supported formats are the following: Uncompressed Transfer Syntax UID Description 1.2.840.10008.1.2 Implicit VR Little Endian 1.2.840.10008.1.2.1 Explicit VR Little Endian 1.2.840.10008.1.2.2 Explicit VR Big Endian Lossless compressed Transfer Syntax UID Description 1.2.840.10008.1.2.5 RLE Lossless 1.2.840.10008.1.2.4.57 JPEG Lossless, Non-Hierarchical (Process 14) 1.2.840.10008.1.2.4.70 JPEG Lossless, Hierarchical, First-Order Prediction 1.2.840.10008.1.2.4.90 JPEG 2000 Image Compression (Lossless Only) Lossy compressed Transfer Syntax UID Description 1.2.840.10008.1.2.4.91 JPEG 2000 Image Compression Blueprint tm 3D Planning Software - v2.1 Scan protocol 5

Scanning Parameters» Recommended parameters Parameter Modality Kernel / Algorithm kvp ma Slice Increment Image Thickness Exposure time Recommended CT Bone or Bone+ 120 or 140 kvp Manual 240 ma DO NOT use auto-ma 1.2 mm - Detector Coverage should be maximum - Helical Thickness 0.625 mm or 1.25 mm - Pitch 0.9 or less - Rotation time 1 sec or less 1000 ms Note: Using the manual-ma setting of 240 ma will provide compatible images. Not doing so will produce images that are incompatible with BLUEPRINT 3D Planning Software.» Display Field Of View (DFOV): Parameter DFOV (axial plane) (Figure 5) DFOV (frontal plane) (Figure 6) Recommended Please include the entire scapula 25 cm or no more 32 cm Please include the entire scapula More than 10 cm Matrix size 512 x 512 Figure 5: DFOV (axial plane) Figure 6: DFOV (frontal plane)» Calculation of humeral version (optional) If the surgeon wishes, the DFOV (frontal view) can be extended so as to visualize the epicondyles of the humerus, and the software will calculate the humeral version. Be aware that the value of the DFOV (axial view) must not exceed 32 cm! If this recommendation is not respected, an error will occur when loading the exam into the software. 6 Blueprint tm 3D Planning Software - v2.1 Scan protocol

Technical Instructions» GE HEALTHCARE In order to define the recommended ma, please follow the next steps: 1. Click on ma button 2. Set manual-ma to 240 ma and dose reduction 0% 3. Set the desired slice thickness for helical CT by clicking on Slice Thickness: - Set the detector coverage to maximum depending on each machine - Set the helical thickness to 0.625 mm or no more than 1.25 mm - Set the pitch to 0.9 or less - Set the rotation time to 1.0 sec» SIEMENS This example works for Somatom Sensation 64 but the user interface is the same in most of Siemens systems. You have two main tabs to configure the scan protocol on Siemens machines: 1. On the Reconstruction tab: - Set the Kernel/Algorithm to Bone 70s, sharp or very sharp - Set the window on Bone - Set the reconstruction increment to 0.6 mm or less 2. On the Scan tab: - Set the quality ref mas to 300 mas - Set the kvp to 120 or 140 kvp - Set the rotation time to 1.0 sec - Set the slice thickness to 1.25 mm or less - Set the pitch to 0.9 or less» OTHER SCANNER BRANDS For any other brand of CT scan machine please refer to the standard recommendations in pages 4, 5 and 6. Blueprint tm 3D Planning Software - v2.1 Scan protocol 7

Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only as techniques used by the design surgeons. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting Wright Medical Technology, Inc. Contact information can be found on the back of this surgical technique, and the package insert is available at www.wmt.com. Please contact your local Wright representative for product availability. BLUEPRINT TM 3D Planning Software HELPline International support Email: blueprint_ous@wright.com Phone number:+ 33 (0)4 76 52 80 56 We are here to help. The helpline is managed 9:00 AM to 6:00 PM CET. 1023 Cherry Road Memphis, TN 38117 800 238 7117 901 867 9971 www.wright.com MANUFACTURER Tornier SAS 161 rue Lavoisier 38330 Montbonnot Saint Martin France +33 (0)4 76 61 35 00 www.tornier.com and denote Trademarks and Registered Trademarks of Wright Medical Group N.V. or its affiliates. 2017 Wright Medical Group N.V. or its affiliates. All Rights Reserved. Prior to using any Tornier device, please review the instructions for use and surgical technique for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. 0459 CE marking is only valid if it is also mentioned on the external package labeling. UDVM179 - May -2017