sc an protocol V2.1

TM

TORNIER

Tornier Upper Extremities

Contents

Introduction

Patient Preparation

Scanning Instructions

Image Instructions

Scanning Parameters

Technical Instructions

4

4

4

5

6

7

4 Blueprinttm 3D planning Software - v2.1 Scan protocol

Introduction

This document describes the guidelines for a Shoulder CT-Scan to be processed by BlueprInTTm 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.

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

» 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

» 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

ScanProtocol

Figure 1: Artifacts generatedby metallic implants

Figure 3: example ofincomplete projections

Figure 2: position of thepatient in the machine

Figure 4: Full scan of the scapula

5Blueprinttm 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

6 Blueprinttm 3D planning Software - v2.1 Scan protocol

Scanning parameters

» recommended parameters

Parameter Recommended

modality CT

Kernel / Algorithm Bone or Bone+

kVp 120 or 140 kVp

mAmanual 240 mADO NOT use auto-mA

Slice Increment 1.2 mm

Image Thickness

- 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

exposure time 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 Recommended

DFOV (axial plane) (Figure 5)Please include the entire scapula25 cm or no more 32 cm

DFOV (frontal plane) (Figure 6)Please include the entire scapulamore 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.

7Blueprinttm 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.

UDVM179 - May -2017

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.

BLUEPRINTTM 3D PLANNING SOfTwARE HELPLINE

International supportEmail: blueprint_ous@wright.comPhone 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.

™ 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.

0459cE marking is only valid if it is also mentioned on the external package labeling.

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