Bayer HealthCare Certegra P3T PA Operating instructions

Brand: Bayer HealthCare

Model: Certegra P3T PA

Type: Operating instructions

CT Injection System

Operation Manual

Personalized Patient Protocol Technology (P3T)

P3T Pulmonary Angiography (PA) Module

for Certegra® Workstation

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.

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

iii

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

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

1 - 1

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 Indica-

tions 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.

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

1 - 2

2 - 3

2 Symbols

This section includes the symbols and icons for the following:

• "Warning Symbols"

• "General Symbols"

2.1 Warning Symbols

2.2 General Symbols

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.

Note

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.

WARNING

CAUTION

NOTICE

Manufacturer (ISO 15223-1, 5.1.1)

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

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

2 - 4

3 - 5

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.

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

3 - 6

4 - 7

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

1 Contrast Type

Defines the contrast concentration value used for

the protocol.

A pick-list of user-

defined contrast

types. For more

information on

defining contrast

types, refer to the

specific injection

system operation

manual. *

350 mg/mL

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

Test Inject

Delivery Method

Selects the way the test injection is calculated

and delivery - by volume or duration.

Volume, Duration Volume

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

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

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

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.

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

4 - 8

10 Weight Bins

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).

Weight Bins

(kg)

< 40 kg,

40–59 kg,

60–74 kg,

75–94 kg,

95–109 kg,

110–125

kg,

> 125 kg

Weight Bins

(lb)

< 86 lb,

86-130 lb,

131-163 lb,

164-207 lb,

208-240 lb,

241-276 lb,

>276 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

Table 4 - 1: P3T Setup Options

UI Display

Order

Name Description Selectable Value

Factory

Default

*A user can modify this parameter during protocol usage.

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

P3T Preset Setup Options

4 - 9

13 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

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

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

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

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

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

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

Table 4 - 1: P3T Setup Options

UI Display

Order

Name Description Selectable Value

Factory

Default

*A user can modify this parameter during protocol usage.

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

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

4 - 10

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

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)

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

24 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

Table 4 - 1: P3T Setup Options

UI Display

Order

Name Description Selectable Value

Factory

Default

*A user can modify this parameter during protocol usage.

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

P3T Preset Setup Options

4 - 11

4.2 Must Review, Must Enter

As part of the preset, some input parameters can be defined as Must Review or Must Enter.

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.

Table 4 - 2: Must Review, Must Enter Options

Check Box Options Example Action and Display During P3T Preset Use

“X” in Must Review box:

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

“X” in Must Enter box:

Action: User is Required to enter a value for

the parameter each time the Preset is used.

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.

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

4 - 12

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.

5 - 13

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.

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

5 - 14

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.

Page is loading ...

Bayer HealthCare Certegra P3T PA Operating instructions

Brand: Bayer HealthCare

Model: Certegra P3T PA

Type: Operating instructions

Download PDF

report

Bayer HealthCare Certegra P3T PA Operating instructions

Bayer HealthCare Certegra P3T PA Operating instructions

Related papers

Other documents