ROSA Knee System - Zimmer Biomet...ROSA ® Knee System SQL xpress Installation Marker Placement 1....

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Protocol Elements DICOM Field Name DICOM Tag Content Referring Physician Name 0008, 0090 Orthopedic Surgeon (complete surname, complete first name) Patient Name 0010, 0010 Last, First, Middle Patient Date of Birth 0010, 0030 YYYY/MM/DD Gender 0010, 0040 M or F Imager Pixel Spacing 0018, 1164 .25mm - .50mm Laterality 0020, 0060 Left or Right Your preferred date format (MM/DD/YYYY or DD/MM/YYYY) may be used in this field Please choose one: Study Description 0008, 1030 For Left Knee, specify: ZBKNEEL For Right Knee, specify: ZBKNEER Protocol Name 0018, 1020 Image Transmission: Only x-rays of patients receiving Zimmer Biomet implants should be transferred upon completion of the Personalized Solutions protocol. Machine Parameters SID (Source to Image Distance) A distance of 72 inches, or 180 cm, is recommended. Set to the fixed value to capture the full leg with automatic source-tilting. It is recommended to use the same standard fixed value for every patient. • Make sure this value is included correctly in the image information or engraved on the images. Imaging Spacing • A value less than 0.50mm is mandatory. A value less than 0.25 mm is recommended. • Make sure this value is included correctly in the image information. *For more details please refer to the X-PSI TM Image Acquisition protocol (1836.1-GLBL) X-Ray Imaging Protocol* ROSA ® Knee System

Transcript of ROSA Knee System - Zimmer Biomet...ROSA ® Knee System SQL xpress Installation Marker Placement 1....

Page 1: ROSA Knee System - Zimmer Biomet...ROSA ® Knee System SQL xpress Installation Marker Placement 1. Position the X-Ray Calibration Straps • Wrap one band firmly around the thigh.

Protocol Elements

DICOM Field Name DICOM Tag Content

Referring Physician Name 0008, 0090Orthopedic Surgeon (complete surname, complete first name)

Patient Name 0010, 0010 Last, First, Middle

Patient Date of Birth 0010, 0030 YYYY/MM/DD†

Gender 0010, 0040 M or F

Imager Pixel Spacing 0018, 1164 .25mm - .50mm

Laterality 0020, 0060 Left or Right

† Your preferred date format (MM/DD/YYYY or DD/MM/YYYY) may be used in this field

Please choose one:

Study Description 0008, 1030For Left Knee, specify: ZBKNEEL

For Right Knee, specify: ZBKNEERProtocol Name 0018, 1020

Image Transmission:Only x-rays of patients receiving Zimmer Biomet implants should be transferredupon completion of the Personalized Solutions protocol.

Machine Parameters SID (Source to Image Distance)

A distance of 72 inches, or 180 cm, is recommended. Set to the fixed value to capture the full leg with automatic source-tilting. It is recommended to use the same standard fixed value for every patient.

• Make sure this value is included correctly in the image information or engraved on the images. Imaging Spacing

• A value less than 0.50mm is mandatory. A value less than 0.25 mm is recommended.• Make sure this value is included correctly in the image information.

*For more details please refer to the X-PSI TM Image Acquisition protocol (1836.1-GLBL)

X-Ray Imaging Protocol*

ROSA® Knee System

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SQL Express Installation

Marker Placement

1. Position the X-Ray Calibration Straps• Wrap one band firmly around the thigh. The band should be at least four inches above the knee joint. • Wrap another band firmly around the calf. The band should be at least four inches below the knee joint.

2. Position the 3D Markers• Place both calibration markers at about 45 degrees relative to the patient lateral plane. - The Zimmer Biomet logo should be legible horizontally. - The curvature of the device must match that of the leg - The markers need to stay in place during the imaging process while changing the patients position from

frontal to lateral

Figure 1: Positioning of X-ray Calibration Straps

Knee Joint

> 4 in. > 4 in.

> 4 in. > 4 in.

The Calibration Marker is Placed at 45 DegreesRelative to the Lateral Plane

Zimmer Biomet Logo is Legible Horizontally

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SQL Express Installation

Imaging ProcedureThe imaging needs to be done only in standing position, weight bearing.

Minimize the distance between the patient and the x-ray detector.

Select an SID value between 72-90 inches (180-228 cm). The SID must cover the entire leg from above the femoral head to below the ankle joint. The SID value should be fixed during the entire study. Do not alter this distance between AP and Lateral images.

A/P Exposure

Place the patient in the frontal position with both legs towards x-ray source as pictured below. The imaging needs to cover the entire leg from above the femoral head to below the ankle joint.

Note:

• No patient movement between any of the sequential images in AP or LAT exposure is allowed.

• The femoral head contour and ankle must be clearly discernable on both images.

• The entire x-ray marker should be visible on the final AP and lateral stitched images.

• The x-ray marker should stay in place during the image process and while changing from the frontal to lateral position. Repositioning of any of the markers is not permitted during the procedure.

LAT Exposure

Place the patient in lateral position and offset the leg as pictured below. The surgical leg should be towards the x-ray detector. The imaging needs to cover the entire leg from above the femoral head to below the ankle joint.

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SQL Express Installation

Support Contact: +1.574.371.3710 [email protected]

Imaging Procedure (cont.)Stitching Requirement (optional)

The stitching can be done automatically on AP and LAT images by available software at the scan center if possible. All acquired images (full leg image (if any) and separate leg image acquistions in AP and Lateral) should be sent to Zimmer Biomet.

An adequate overlap between images should exist to make an accurate stitching possible. It is recommended that images are not stitched/ overlapped in the knee joint area.

The femorotibial junctions and bone contours are clearly visible. The x-ray markers are entirely visible on images and stitching points are outside of the knee joint region.

Visibility of all required anatomy:

• Femoral head contour

• Ankle

• Entire knee joint

• Ideally images should not stitch/ overlap in these areas

• Visibility of entire x-ray marker on both the AP and LAT images

Following machine parameters, as well as

patient parameters, are recorded correctly and

are the same for all images in the DICOM tags:

• SID (focal length)

• Imager Pixel Spacing

• Patient gender (male/female)

• Laterality (left/right)

• Surgeon’s name

• Patient name or Zimmer Biomet Patient ID

Following parameters MUST be annotated on

each AP and LAT image:

• SID

• Laterality (left/right)

2535.1-GLBL-en REV 0519

The scan tech should check the following on full APand LAT images, before the image transfer:

This material is intended for health care professionals. Distribution to any other recipient is prohibited. For indications, contraindications, warnings, precautions, potential adverse effects and patient counselling information, see the package insert; visit www.zimmerbiomet.com for additional product information. All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to Zimmer Biomet or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet. Check for country product clearances and reference product specific instructions for use.

Not for distribution in France.

© 2019 Zimmer Biomet

Example of Good Image Quality and Stitchingin A/P and LAT