P3T PA Module Operation Manual Rev E Feb 2019

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). Hardware operating specifications and feature availability may vary by country. Check with your local product representative and country-specific operating instructions. A glossary of the symbols can be found in Section 2 of this manual.

i

Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module

ii

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 ... 1 - 1

2 Symbols ... 2 - 3 2.1 Warning Symbols ... 2 - 3 2.2 General Symbols ... 2 - 3

3 Product Overview ... 3 - 5 3.1 Product Overview ... 3 - 5 3.2 Theory of Operation... 3 - 5 3.2.1 Introduction to Presets... 3 - 5

4 P3T Preset Setup Options... 4 - 7 4.1 Setup Options ... 4 - 7 4.2 Must Review, Must Enter... 4 - 11 4.3 DualFlow... 4 - 12

5 Managing Presets ... 5 - 13 5.1 Create New Preset ... 5 - 13 5.2 Modify a Preset ... 5 - 15 5.3 Delete a Preset... 5 - 17 5.4 Rearrange Preset Order... 5 - 18

6 Using Presets ... 6 - 19 6.1 Using a Preset to Generate a Protocol... 6 - 19 6.2 Modify P3T Input Parameters ... 6 - 21 6.3 Modify a P3T Protocol After a Transit Bolus ... 6 - 22

7 Common P3T Work Flows ... 7 - 23 7.1 Minimum Injection Duration ... 7 - 23 7.2 Transit Bolus... 7 - 23 7.3 Bolus Tracking ... 7 - 24 7.4 DualFlow Configuration ... 7 - 25

iii

Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module

iv

1

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). Further instructions on loading and injecting, as well as other important information can be found in the operations manuals for the specific injection system. Please read all the information included in this manual. It is important to understand this information to help ensure safe and effective usage of this product.

1.2 Essential Claims • •

P3T PA computes individual contrast injection protocols and scan timing for individualized dosing. P3T PA increases the consistency of individualized injection protocols amongst clinicians.

1.3 Intended Use P3T PA is intended for use with CT Angiography. P3T PA computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration.

1.4 Indications for Use P3T PA is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic and abdominal aorta. NOTE: P3T PA has not been validated for anatomical regions outside of the stated Indications For Use.

1.5 Restricted Sale Federal (USA) law restricts this device to sale by or on the order of a physician.

1.6 Disclaimers Screen images in this manual are for illustration purposes only. Actual screens may vary.

1-1

Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module

1-2

2

Symbols This section includes the symbols and icons for the following: • •

"Warning Symbols" "General Symbols"

2.1 Warning Symbols

WARNING

CAUTION

NOTICE

Note

Indicates that the information is a warning. Warnings advise the user of circumstances that could result in injury or death to the patient or operator. Read and understand the warnings before operating the injection system. Indicates that the information is a caution. Cautions advise the user of circumstances that could result in minor or moderate injury to the patient or operator. Read and understand the cautions before operating the injection system. Indicates that the information is a notice. Notices advise the user of circumstances that could result in damage to the device. Read and understand the notices before operating the injection system. Indicates that the information that follows is additional important information or a tip that will help the user recover from an error or reference to related information within the manual.

2.2 General Symbols

Manufacturer (ISO 15223-1, 5.1.1)

Authorized Representative in the European Community (ISO 15223-1, 5.1.2)

2-3

Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module

2-4

3

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). P3T PA is a module available as part of the P3T platform that enables optimizing of contrast injection protocols for CT angiography of pulmonary vasculature. This module automates the calculation of individualized contrast injection protocols that would otherwise have to be performed manually by the user. The user enters the patient's weight, the iodine concentration of the contrast media, and other key parameters for the contrast injection protocol. Based on this input, P3T generates a protocol specifically tailored to the individual patient by delivering a measured amount of contrast at a flow rate that will allow all of the iodine to be delivered within the duration of the scan. NOTE: P3T does not determine the appropriate contrast timing (i.e., flow rate or injection duration). Physicians must determine the contrast timing. The overall injection protocol consists of two sub-protocols: an optional Pre-Diagnostic Protocol, and a Diagnostic Protocol. The Pre-Diagnostic Protocol includes an optional Test Injection and/or Transit Bolus phase. The Transit Bolus phase injects a small amount of contrast or saline and is used to help determine the time to peak enhancement in a specific area of interest and the peak enhancement level achieved (information that is then entered into P3T to help configure the final diagnostic protocol). NOTE: A Test Injection is available. A Test Inject phase injects a small amount of saline and is used to check vein patency. Refer to the specific injection system operation manual for more information.

3.2 Theory of Operation 3.2.1 Introduction to Presets P3T Presets are user-defined templates that specify values for the input parameters required to generate a P3T protocol. Presets enable the user to reuse specific input parameters without needing to enter or modify input parameter values. To create a personalized P3T protocol for each patient, the user recalls the defined preset from memory and adds patient and procedure-specific information such as patient weight and contrast concentration. NOTE: Refer to “Using Presets” on page 6 - 19 for information on using presets.

3-5

Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module

3-6

4

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 Order

Name

Description

Selectable Value

Factory Default

350 mg/mL

1

Contrast Type

Defines the contrast concentration value used for the protocol.

A pick-list of userdefined contrast types. For more information on defining contrast types, refer to the specific injection system operation manual. *

2

Test Inject

Includes a test injection as part of the protocol.

Yes, No *

No

3

Test Inject Fluid

Defines the fluid to be used during the test injection.

Contrast, Saline

Saline

4

Test Inject Delivery Method

Selects the way the test injection is calculated and delivery - by volume or duration.

Volume, Duration

Volume

5

Test Inject Volume

Sets the volume for the test injection when the Test Inject Delivery Method is set to Volume.

10 mL- 50 mL in increments of 1 mL *

20 mL

6

Test Inject Duration

Sets the duration of the test injection when the Test Inject Delivery Method is set to Duration

3 seconds -15 seconds in increments of 1 second *

5 seconds

7

Transit Bolus

Configures the preset to include a transit bolus in the pre-diagnostic sub-protocol. A transit bolus consists of a contrast bolus follow by a saline bolus.

Yes, No *

No

8

Transit Bolus Contrast Volume

Sets the default volume for a contrast bolus portion of the Transit Bolus if the Transit Bolus parameter is set to Yes.

10mL - 25mL in increments of 1mL *

20 mL

9

Transit Bolus Saline Volume

Sets the default volume for a saline bolus portion of the Transit Bolus if the Transit Bolus parameter is set to Yes.

0mL - 50mL in increments of 1mL *

40 mL

*A user can modify this parameter during protocol usage. ** A user can modify this parameter during protocol usage and after the Transit Bolus.

4-7

Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module

Table 4 - 1: P3T Setup Options UI Display Order

10

11

12

Name

Description

Factory Default Weight Bins (kg) < 40 kg, 40–59 kg, 60–74 kg, 75–94 kg, 95–109 kg, 110–125 kg, > 125 kg

Enables a user to create seven custom weight bins. Units can be in pounds or kilograms depending on system settings.

Upper limit of each Weight Bin can be defined from 20 – 320 kg (44 – 705 lb).

Maximum Flow Rate

Sets the maximum flow rate allowed for the protocol. If the P3T protocol is generated such that it exceeds the max flow rate value, the protocol will automatically be adjust so that the max flow rate value is not exceeded and the user is notified of the protocol adjustment.

5 mL/s - 10 mL/s in increments of 0.1 mL/s **

6.0 mL/s

Duration Adjustment

Used to calculate the duration for the first phase of the diagnostic protocol. The Duration Adjustment is added to the Scan Duration to determine the injection duration of the first phase. Contrast injection durations should be sufficiently long to account for the dispersive effects of the cardio pulmonary system. It is therefore advisable to include additional injection duration to the bolus to avoid suboptimal enhancement towards end of the scan. The Duration Adjustment setup option enables the user to configure this additional injection duration. Since P3T computes the flow rate of the contrast phase in the Diagnostic Protocol based on contrast volume and injection duration, a larger value of Duration Adjustment results in a longer injection duration and a lower flow rate.

0 seconds -10 seconds in increments of 1 second

4 seconds

Weight Bins

*A user can modify this parameter during protocol usage. ** A user can modify this parameter during protocol usage and after the Transit Bolus.

4-8

Selectable Value

Weight Bins (lb) < 86 lb, 86-130 lb, 131-163 lb, 164-207 lb, 208-240 lb, 241-276 lb, >276 lb,

P3T Preset Setup Options

Table 4 - 1: P3T Setup Options UI Display Order

Name

Description

Selectable Value

Factory Default

Weight Factors

Enables the user to edit the default weight factors, which determine the gI/kg used in the first contrast phase of the diagnostic protocol.

0.05 to 1.0 gI/kg, in increments of 0.001

0.5, 0.4, 0.375, 0.35, 0.31, 0.30 gI/kg

14

Minimum Injection Duration

Specifies the minimum injection duration of the diagnostic contrast phase. In order to reduce contrast volume, short minimum injection duration value may be desired for very fast scans (3-5 seconds) when the user is comfortable with higher flow rates for a patient. The minimum injection duration requirement is enforced after the Duration Adjustment is added to the Scan Duration. For example, in the case of a 5 second Scan Duration, a 4 second Duration Adjustment, and a Min Injection Duration of 10 seconds: the calculated injection duration of the first phase of the P3T protocol is 9 seconds, but would be increased to 10 seconds based on the Min Injection Duration specified.

6 seconds -16 seconds in increments of 1 second

13 seconds

15

Saline Flush Volume

Sets the volume for the saline flush phase. Set the volume to zero to eliminate the saline flush phase

0 mL - 50 mL in increments of 1 mL *

30 mL

16

Protocol Truncation Adjustment

Sets the minimum time between when a phase containing contrast ends and when the scan ends. Because of the time it takes for the contrast to travel from the injection site to the region of interest, contrast injected too close to the end of the scan does not contribute to the enhancement in that region

0 seconds - 10 seconds in increments of 1 second

3 seconds

17

Maximum Iodine Load

Sets the maximum iodine load for the first contrast phase of the diagnostic injection only.

20 gI - 80 gI in increments of 1 gI *

38 gI

18

Minimum Iodine Load

Sets the minimum iodine load for the first contrast phase of the diagnostic injection only.

0 gI - 50 gI in increments of 1 gI

20 gI

19

Maximum Diagnostic Contrast Volume

Sets the maximum contrast volume allowed for the protocol. If the P3T protocol is generated such that it exceeds the max contrast volume value, the protocol will automatically be adjusted so that the max volume is not exceeded and the user is notified of the protocol adjustment.

79 mL - 194 mL in increments of 1mL **

194 mL

13

*A user can modify this parameter during protocol usage. ** A user can modify this parameter during protocol usage and after the Transit Bolus.

4-9

Personalized Patient Protocol Technology (P3T): P3T Pulmonary Angiography (PA) Module

Table 4 - 1: P3T Setup Options UI Display Order

20

Factory Default

Name

Description

Selectable Value

Maximum Diagnostic Saline Volume

Sets the maximum saline volume allowed for the protocol. If the P3T protocol is generated such that it exceeds the maximum saline volume value, the protocol will automatically be adjusted so that the max volume is not exceeded and the user is notified of the protocol adjustment.

0 mL - 194 mL in increments of 1 mL **

194 mL

325 psi

21

Pressure Limit

Defines the pressure limit to be stored with the Preset

A pick-list of available pressure limits (50, 100, 150, 200, 250, 300, 325 psi)

22

Scan Duration

Identifies the length of time for the Diagnostic portion of the scan acquisition.

1 second - 40 seconds

10 seconds

Weight Entry Method

Defines the way in which the user enters patient weight. For Weight Bins, the system displays five defined weight ranges for the patient. For Key Pad, the system display a numeric keypad for patient weight entry. NOTE: If the user configures the Weight Entry Method to use Weight Bins, a representative weight within the selected range will be used to calculate the contrast dosage. As a result, the Key Pad weight entry method is more accurate compared to the Weight Bin entry method.

Weight Bin, Key Pad

Key Pad

DualFlow

Enables the use of DualFlow for the P3T Preset. When Yes is selected, the underlying algorithm will consider a contrast dilution phase for the protocol. In some cases, even through the Preset may include DualFlow, the algorithm 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 the injection of the DualFlow phase). Since DualFlow is primarily beneficial for maintaining opacification of the right heart structures, it may not be required for pulmonary angiography studies. Also, by configuring the Preset for P3T PA to not include DualFlow, initial contrast volume calculation could be lower than if it were included.

Yes, No

No

23

24

*A user can modify this parameter during protocol usage. ** A user can modify this parameter during protocol usage and after the Transit Bolus.

4 - 10

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

“X” in Must Review box:

Example

Action and Display During P3T Preset Use Action: User should review the value of the parameter each time the P3T Preset is used. But, there is no Required action. Display: The parameter will move towards the top of the list and be highlighted in beige Action: User is Required to enter a value for the parameter each time the Preset is used.

“X” in Must Enter box: Display: The parameter will move towards the top of the list and be highlighted in beige

No “X” in either box

Action: User may enter a value for the parameter each time the Preset is used. But, there is no Required action. Display: The parameter will appear in the list, but in no particular order

No check boxes and gray shading

Action: User will not be able to change the value for the parameter when the Preset is used. The value can only be changed during the Preset creation. Display: The parameter will NOT be displayed in the list.

NOTE: During use of the preset, some input parameters can be modified. The Must Review designation provides a faster method to highlight specific parameters. Test Inject is always a Must Review value. NOTE: Patient weight is always a Must Enter value.

4 - 11

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). NOTE: Since DualFlow is primarily beneficial for maintaining opacification of the right heart structures, it may not be required for pulmonary angiography studies. NOTE: By configuring P3T to not include DualFlow, initial contrast volume calculations could be lower than if it were included. NOTE: Shorter scan times for pulmonary angiography exams can obviate the need for DualFlow. DualFlow may be appropriate to use for slower scanners and gated PE exams. For more information on DualFlow refer to the operation manual for the specific injection system.

4 - 12

5

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 How to move presets from one folder to another How to create a copy of a preset

Configuration of presets is typically done during initial set up and during injection protocol reviews. It is recommended that the setup options be reviewed by clinicians responsible for specifying injection protocols in a facility.

5.1 Create New Preset 1. From the launch menu, select Setup > P3T Preset Setup.

Figure 5 - 1: P3T Preset Setup 2. Select Create New Preset. 3. Under Presets, select P3T PA.

5 - 13

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. Modify a preset. a. Use the UP or DOWN arrows to scroll through the parameters.

b. Under CURRENT, select the displayed Preset parameter to modify the value. c. Enter or choose the values from the keypad or pick list.

5 - 14

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. e. Optionally, under MUST ENTER, select the box to require that a user enter a value for this option. Deselect the box to remove the parameter entry requirement. NOTE: The System highlights parameters marked as MUST ENTER when the user uses the preset, and the user must provide a value to generate a protocol. 7. In Select Region to Save, select the folder in which to store the preset.

Figure 5 - 4: Select Region to Save NOTE: The user can store a P3T preset in any folder. 8. Optionally, select Reset to return the preset to the default values. 9. Select SAVE. 10. Enter a name for the Preset, and select Enter. 11. Select Yes to confirm the Preset name and storage folder.

5.2 Modify a Preset 1. From the launch menu, select Setup > P3T Preset Setup. 2. Select Edit Existing Preset. 3. Select the folder in which the preset is stored.

5 - 15