Bayer HealthCare Certegra P3T PA Operation Manual
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Bayer HealthCare Certegra P3T PA Operation Manual

Pulmonary angiography module
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Operation Manual
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Personalized Patient Protocol Technology (P3T)
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P3T Pulmonary Angiography (PA) Module
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for Certegra® Workstation
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Summary of Contents for Bayer HealthCare Certegra P3T PA

  • Page 1 Operation Manual Personalized Patient Protocol Technology (P3T) P3T Pulmonary Angiography (PA) Module for Certegra® Workstation...
  • Page 3 Personalized Patient Protocol Technology (P3T) P3T Pulmonary Angiography (PA) Module Operation Manual Report any serious incident that has occurred in relation to this device to Bayer (radiology.bayer.com/contact) and to your local European competent authority (or, where applicable, to the appropriate regulatory authority of the country in which the incident has occurred).
  • Page 4 Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module...

  • Page 5: Table Of Contents

    Table of Contents 1 Introduction ........................1 - 1 1.1 Purpose ................................1 - 1 1.2 Essential Claims..............................1 - 1 1.3 Intended Use ..............................1 - 1 1.4 Indications for Use............................. 1 - 1 1.5 Restricted Sale..............................1 - 1 1.6 Disclaimers ...............................
  • Page 6 Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module...

  • Page 7: Introduction

    Introduction 1.1 Purpose This document provides instructions for using the Personalized Patient Protocol Technology (P3T) ® ® Pulmonary Angiography (PA) (P3T PA) on the MEDRAD Stellant CT Injection System with Certegra ® ® Workstation (Stellant CWS) and on the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation (Stellant FLEX).
  • Page 8 Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module 1 - 2...

  • Page 9: Symbols

    Symbols This section includes the symbols and icons for the following: • "Warning Symbols" • "General Symbols" 2.1 Warning Symbols Indicates that the information is a warning. Warnings advise the user of WARNING circumstances that could result in injury or death to the patient or operator. Read and understand the warnings before operating the injection system.
  • Page 10 Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module 2 - 4...

  • Page 11: Product Overview

    Product Overview • "Product Overview" • "Theory of Operation" 3.1 Product Overview P3T allows users to create individualized contrast injection protocols based on patient characteristics, contrast media properties and other procedure parameters. Contrast dosage is determined based on the iodine to be delivered to the patient (for example, a heavier patient will receive more grams of iodine while a lighter patient will receive fewer grams of iodine).
  • Page 12 Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module 3 - 6...

  • Page 13: P3T Preset Setup Options

    P3T Preset Setup Options 4.1 Setup Options The Preset setup options allow users to configure the module according to work flow, policies, and preferences of each facility. Table 4 - 1: P3T Setup Options UI Display Factory Name Description Selectable Value Order Default A pick-list of user-...
  • Page 14 Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module Table 4 - 1: P3T Setup Options UI Display Factory Name Description Selectable Value Order Default Weight Bins (kg) < 40 kg, 40–59 kg, 60–74 kg, 75–94 kg, 95–109 kg, 110–125 Upper limit of each Enables a user to create seven custom weight...
  • Page 15 P3T Preset Setup Options Table 4 - 1: P3T Setup Options UI Display Factory Name Description Selectable Value Order Default 0.5, 0.4, Enables the user to edit the default weight 0.05 to 1.0 gI/kg, in 0.375, 0.35, Weight Factors factors, which determine the gI/kg used in the increments of 0.001 0.31, 0.30 first contrast phase of the diagnostic protocol.
  • Page 16 Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module Table 4 - 1: P3T Setup Options UI Display Factory Name Description Selectable Value Order Default Sets the maximum saline volume allowed for the protocol. If the P3T protocol is generated such Maximum 0 mL - 194 mL in that it exceeds the maximum saline volume...

  • Page 17: Must Review, Must Enter

    P3T Preset Setup Options 4.2 Must Review, Must Enter As part of the preset, some input parameters can be defined as Must Review or Must Enter. Table 4 - 2: Must Review, Must Enter Options Check Box Options Example Action and Display During P3T Preset Use Action: User should review the value of the parameter each time the P3T Preset is used.

  • Page 18: Dualflow

    Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module 4.3 DualFlow When Yes is selected, the System considers a DualFlow phase for the protocol. In some cases, even though the module is configured to include DualFlow, the system may not generate a protocol with a DualFlow phase (for example, when scan durations are short and the scan is completed before the time of injection of the DualFlow phase).

  • Page 19: Managing Presets

    Managing Presets This section describes how to: • "Create New Preset" • "Modify a Preset" • "Delete a Preset" • "Rearrange Preset Order" Features to organize presets within the protocol manager are also discussed including: • How to change the display order of presets •...
  • Page 20 Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module Figure 5 - 2: Create New Preset The preview pane displays the default values for the preset parameters. 4. Select OK. A preset entry screen displays. 5. Select the Region to Save. Press SAVE. Figure 5 - 3: Preset Entry Screen 6.

  • Page 21: Modify A Preset

    Managing Presets d. Optionally, under MUST REVIEW, select the box to require that a user review the value when setting the protocol. Deselect the box to remove the confirmation requirement. NOTE: The System highlights parameters marked as MUST REVIEW when the user is using the preset.
  • Page 22 Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module Figure 5 - 5: Edit a Preset • Alternatively, select View All. 4. Under PRESETS, select the preset to review the parameters. 5. Select OK to edit the parameters. 6. Modify the desired preset. See step 6 in "Create New Preset"...

  • Page 23: Delete A Preset

    Managing Presets Figure 5 - 7: Move NOTE: Available when in a different folder than originally saved. 8. Select Yes to confirm the preset name and storage folder. 5.3 Delete a Preset 1. From the launch menu, select Setup > P3T Preset Setup. 2.

  • Page 24: Rearrange Preset Order

    Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module Figure 5 - 8: Delete Preset 5.4 Rearrange Preset Order 1. Select Setup > Protocol Manager Setup. 2. Select the desired folder. 3. Select the protocol name. 4. Select Move Up or Move Down. Figure 5 - 9: Select Protocol Manager Setup 5 - 18...

  • Page 25: Using Presets

    Using Presets WARNING Vessel Hazard - Serious patient injury or death may result. • Ensure that the programmed flow rate meets hospital guidelines. Patient injury could result if P3T modules are used with patients with compromised renal function or other contrast adverse related health issues. P3T modules are not recommended if performing a procedure on a patient with compromised renal function or some other contrast adverse related health issue.
  • Page 26 Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module Figure 6 - 2: Protocol Manager 3. Under Protocols, select the preset. NOTE: P3T Presets are identified by the P3T logo. 4. Alternatively, select P3T to view an alphabetical listing of all stored P3T presets. 5.

  • Page 27: Modify P3T Input Parameters

    Using Presets Figure 6 - 4: Confirm or Cancel Protocol NOTE: The Preview button will be available once the “Must Enter” values have been entered. NOTE: Preview will automatically be displayed when the More Parameters button is selected. 9. Optionally, select Cancel to exit Protocol Manager without generating a P3T Protocol. 10.

  • Page 28: Modify A P3T Protocol After A Transit Bolus

    Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module c. Select OK. The Home tab displays. 2. To modify flow rate or volume: a. Select Flow Rate or Volume, and enter the values. b. Select Enter. 6.3 Modify a P3T Protocol After a Transit Bolus If a Transit Bolus was included in the Pre-Diagnostic Protocol, pressing the START button after the Test Inject phase will initiate the Transit Bolus phase.

  • Page 29: Common P3T Work Flows

    Common P3T Work Flows • "Minimum Injection Duration" • "Transit Bolus" • "Bolus Tracking" • "DualFlow Configuration" 7.1 Minimum Injection Duration 1. From the launch menu, select Setup > P3T Preset Setup. 2. Select Create New Preset or edit existing preset. 3.

  • Page 30: Bolus Tracking

    Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module Figure 7 - 2: Select Transit Bolus 6. Select Yes. 7. Under MUST REVIEW select the box. 8. In Select Region to Save, select the folder in which to store the preset. 9.

  • Page 31: Dualflow Configuration

    Common P3T Work Flows Figure 7 - 3: De-Select Transit Bolus 6. Select No. 7. Optionally, under MUST REVIEW and/or MUST ENTER. Deselect the box(es) to remove the confirmation requirement. 8. In Select Region to Save, select the folder in which to store the preset. 9.
  • Page 32 Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module Figure 7 - 4: Select DualFlow 6. Select Delivery Method. 7. Optionally, under MUST REVIEW and/or MUST ENTER, deselect the box(es) to remove the confirmation requirement. 8. In Select Region to Save, select the folder in which to store the preset. 9.
  • Page 34 i - ii MEDRAD® <ADD-PRODUCT> Bayer reserves the right to modify the specifications and features described herein or to discontinue any product or service identified in this publication at any time without prior notice or obligation. Please contact your authorized representative from Bayer for the most current information.

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