Prefilled Syringe Adapter ( PFA ) Operation Manual Rev C

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).

MEDRAD® MRXperion Prefilled Syringe Adapter

Operation Manual

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1 Overview ...1 - 1 1.1 Indications for Use ...1 - 1 1.2 Contraindications...1 - 1 1.3 Symbols...1 - 1 1.4 Prefilled Syringe Adapter (PFA) Components ...1 - 3 1.5 Prefilled Syringe Adapter Usage ...1 - 4 1.6 Home Screen ...1 - 5 1.7 Injector Head Overview ...1 - 6 1.8 PFA Installation Features ...1 - 7

2 Configuration...2 - 9 2.1 Enabling Prefilled Syringe Adapter (PFA) Feedback...2 - 9 2.2 Contrast Configuration ...2 - 9 2.2.1 Adding a New Contrast Type...2 - 9 2.2.2 Editing an Existing Contrast Type ... 2 - 11 2.2.3 Contrast Type Management... 2 - 12

3 Preparing for an Injection, Arming, and Injecting...3 - 13 3.1 Control Room Preparation ... 3 - 14 3.2 Injection Preparation... 3 - 16 3.2.1 Attach and Prime the Tubing... 3 - 17 3.3 Arming and Injecting... 3 - 17 3.4 Removing Disposables ... 3 - 18

4 Inspection, Cleaning, and Disinfection of the PFA ...4 - 19 4.1 Inspecting the PFA... 4 - 19 4.2 Cleaning the PFA... 4 - 19 4.3 Disinfecting the PFA... 4 - 20

5 Troubleshooting ...5 - 21 5.1 Selected Source Type Not Compatible with PFAs from Bayer ... 5 - 21 5.2 PFA Piston is Not Engaged with Prefilled Syringe Plunger ... 5 - 21

6 Specifications...6 - 23 6.1 Injector (Scan Room Unit) Dimensions with PFA Installed... 6 - 23 6.2 Prefilled Syringe Adapter (PFA) Dimensions ... 6 - 23 6.3 System Capabilities with PFA Installed... 6 - 24 6.4 Fluid Delivery Performance When a PFA is in Use ... 6 - 24

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MEDRAD® MRXperion Prefilled Syringe Adapter

Operation Manual

1

1-1

Overview For complete operational information, warnings, and cautions, please refer to the MEDRAD® MRXperion MR Injection System operation manual.

This manual applies to the MEDRAD® MRXperion Prefilled Syringe Adapters (Catalog Numbers: MRXP PFA GN, MRXP PFA PE, MRXP PFA YW, MRXP PFA GY) for use with MEDRAD® MRXperion MR Injection System (Catalog Number: MRXP 200). Screen images in this manual are for illustration purposes only. Actual screens may vary.

1.1 Indications for Use This device is indicated for use with the MEDRAD® MRXperion MR Injection System, which is a syringe-based fluid delivery system indicated for delivery of contrast media and saline during MR procedures. This device is not to be used for any purpose other than those for which the device is indicated. Only trained healthcare professionals are intended to operate this device.

1.2 Contraindications None known.

1.3 Symbols MR Conditional: Has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use as defined by the ASTM International Standards for MRI Device Marking (IEC 62570, 7.3.2)

Do not discard.

Consult instructions for use (ISO 15223-1, 5.4.3)

Manufacturer (ISO 15223-1, 5.1.1)

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

Temperature range (ISO 15223-1, 5.3.7)

Humidity range (ISO 15223-1, 5.3.8)

1-2

MEDRAD® MRXperion Prefilled Syringe Adapter

Atmospheric pressure range (ISO 15223-1, 5.3.9)

Date of manufacture (ISO 15223-1, 5.1.3)

Serial number (ISO 15223-1, 5.1.7)

Catalog number (ISO 15223-1, 5.1.6)

This side up (ISO 7000, 0623)

Keep dry (ISO 15223-1, 5.3.4)

Fragile, handle with care (ISO 15223-1, 5.3.1)

PN

Part number

Net weight (ISO 7000, 1321B)

Quantity (IEC TR 60878, 2794)

Indicates that this device conforms to the requirements of the European Medical Device Directive 93/42/EEC

Do not immerse.

Operation Manual

WARNING

1-3

Indicates that the information is a warning. Warnings advise you of circumstances that could result in injury or death to the patient or operator. Read and understand the warnings before operating the injection system.

 CAUTION

Indicates that the information is a caution. Cautions advise you 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.

NOTICE

Indicates that the information is a notice. Notices advise you 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 important information or a tip related to the proper functionality of the system that will help the operator to recover from an error or point to related information within the manual. Read and understand the notes before operating the system.

1.4 Prefilled Syringe Adapter (PFA) Components

Prefilled syringe removal access hole Orange locking ring secures syringe

Cradle holds syringe in place Adapter piston contacts syringe plunger Pinch guard covers adapter piston

3 MR

Optical sensing notifies injector which adapter is installed NOTE: Do not discard the prefilled syringe adapter after use. The adapter is reusable. For cleaning instructions, refer to "Section 4.2 - Cleaning the PFA".

1-4

MEDRAD® MRXperion Prefilled Syringe Adapter

1.5 Prefilled Syringe Adapter Usage There are four color-coded prefilled syringe adapters available from Bayer:

Supplier

Name

PFA #

Magnevist Bayer

Gadovist

5, 10

1

Primovist Eisai

Prohance¹

Bracco

MultiHance²

Bayer

Volume (mL)

5, 7.5, 10 5, 10

2

13, 17 10, 15, 20

Magnevist

15, 20

Gadovist

15, 20

3

Bracco

ProHance²

Guerbet

Dotarem²

15, 20

GE

Clariscan

10, 15, 20

Guerbet Japan

Magnescope¹

4

¹ Only available in Japan ² Not available in Japan

Figure 1 - 1: Compatible Prefilled Syringes

10, 15, 17

10, 11, 13, 15, 20

Operation Manual

1-5

1.6 Home Screen 3

2

4

1 6

5

#

Name

Description

1

Launch Menu

Select to access Setup, Calculators, VirtualCare (if installed), Help, and Shutdown.

2

Fluids

Select to access the Information screen and choose the Fluid A source type (contrast). When a PFA is installed, an adapter with the color and number of the installed PFA will display. If nothing is installed on Side A of the injector, Q

3

a syringe outline will appear when: •

PFA Status Indicator

• Q

PFA feedback is enabled, but “Use Prefilled Syringe with Adapter (PFA)” is unchecked OR PFA feedback is disabled.

a PFA outline will appear when: •

PFA feedback is enabled and “Use Prefilled Syringe with Adapter (PFA)” is checked.

4

Lock/Arm/Disarm

Select to lock a protocol, arm the injector, and disarm the injector.

5

PFA Information

Applicable information related to PFA compatibility with the selected contrast will be shown if PFA Feedback is enabled.

6

Fluid A

Select to display most recent Fluid A values entered. Press OK to select again or Cancel to choose new values.

1-6

MEDRAD® MRXperion Prefilled Syringe Adapter

1.7 Injector Head Overview

1

1

2

3 7

4 5 6 12 7

11

8 9

10

13 #

Name

#

Name

1

Volume Indicator (Side A or B)

8

Arm Button

2

B Button

9

Start/Hold Button

3

A Button

10

Abort Button

4

Prime Button

11

KVO Button

5

I Checked for Air Confirmation Button

12

Test Inject Button

6

Enable Piston Control Button

13

Manual Knobs

7

Forward and Reverse Piston Controls (Side A or B)

Operation Manual

1-7

1.8 PFA Installation Features The system is designed with four features that decrease the time and steps to install and remove the PFA to the injector head. Q

Non-rotational orientation: When installing a PFA onto the injector head, alignment is unnecessary. Push the PFA into the Side A opening.

Q

Auto Docking: When Auto Advance is configured to be ON and a PFA is installed, the injector piston automatically advances and docks with the PFA piston.

Q

Auto Advance: When Auto Advance is configured to be ON and a PFA is installed, the injector piston automatically docks with the PFA piston and positions it level with the pinch guard.

Q

Auto Retract: When Auto Retract is configured to be ON and the PFA is removed, the injector piston rod will automatically retract into the injector head.

1-8

MEDRAD® MRXperion Prefilled Syringe Adapter

Operation Manual

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2-9

Configuration

2.1 Enabling Prefilled Syringe Adapter (PFA) Feedback System Setup enables the operator to configure settings that affect operation of the overall system. 1.

From the Launch Menu at the bottom left of the Home screen, select Setup, then select System Setup.

2.

On the second page of System Setup, select Prefilled Syringe Adapter (PFA) Feedback.

3.

Select ON or OFF: Q

When “Prefilled Syringe Adapter (PFA) Feedback” is turned ON: The system will recommend the compatible PFA for the selected contrast. The recommendation will be shown on the injector head and on the display.

Q

When “Prefilled Syringe Adapter (PFA) Feedback” is turned OFF (Default): The system does not provide recommendations.

4.

Select OK.

5.

Select Yes to save changes.

2.2 Contrast Configuration 2.2.1 Adding a New Contrast Type NOTE: If “PFA Feedback” is enabled, names of contrasts that are compatible with PFAs will be pre-populated. 1.

From the Launch Menu at the bottom left of the Home screen, select Setup, then select Fluid Delivery Setup.

2.

Select Contrast Types on the Fluid Delivery Setup screen.

3.

Select Add New (1) on the Contrast Configuration screen.

1

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MEDRAD® MRXperion Prefilled Syringe Adapter

4.

Edit information for each of the following items by selecting a tab (2) on the left of the screen and entering the parameters:

7 4 3 2

5

6 Figure 2 - 1: Adding a New Contrast Type Q

Contrast Name: Select an existing contrast name from the list (3) or add a new contrast name by selecting Add New (4) and entering the name of the contrast using the keyboard window that will appear on the display. Select Enter to save the new contrast name to the list. Select the contrast name from the list.

NOTE: For Prohance, answer “Yes” or “No” when asked “Is this contrast media sold by Eisai?” This will determine which adapter is appropriate for the contrast media. Q

Concentration: Select an existing concentration from the list (3) or add a new concentration by selecting Add New (4) and entering the concentration (5). Select Enter (6) to save the new concentration to the list. Select the concentration from the list.

Q

Vial Size: Select an existing vial size from the list (3) or add a new vial size by selecting Add New (4) and entering the vial size (5). Select Enter (6) to save the new vial size to the list. Select the vial size from the list.

Q

Dosage: Select an existing dosage from the list (3) or add a new dosage by selecting Add New (4) and entering the dosage (5). Select Enter (6) to save the new dosage to the list. Select the dosage from the list.

Q

Weight Range: Enter the weight range identified on the contrast package insert.

Q

Minimum Age: Enter the minimum age identified on the contrast package insert.

NOTE: A saved value can be deleted from the list by pressing the X button. Select Yes in the message window to confirm deletion. Deleting a value will also delete any saved contrast types using that value. 5.

Once the contrast name, concentration, vial size, and dosage have been selected, a Save (7) button will appear at the top of the screen. Review the selections in the header and select Save to save the Contrast Type. Select Yes on the message window to confirm.

6.

Select OK to save all changes and exit Contrast Configuration.

Operation Manual

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2.2.2 Editing an Existing Contrast Type 1.

Select Contrast Types on the Fluid Delivery Setup screen.

2.

Select a saved Contrast Type (1) on the Contrast Configuration screen and select Edit (2).

1

2 Figure 2 - 2: Select an Existing Contrast Type to edit 3.

Edit information for each of the following items by selecting a tab on the left of the screen and entering the parameters (See Figure 2 - 3): Q

Contrast Name: Select an existing contrast name from the list (3) or add a new contrast name by selecting Add New (4) and entering the name of the contrast using the keyboard window that will appear on the display. Select Enter to save the new contrast name to the list. Select the contrast name from the list.

NOTE: For Prohance, answer “Yes” or “No” when asked “Is this contrast media sold by Eisai?” This will determine which adapter is appropriate for the contrast media. Q

Concentration: Select an existing concentration from the list (3) or add a new concentration by selecting Add New (4) and entering the concentration (5). Select Enter (6) to save the new concentration to the list. Select the concentration from the list.

Q

Vial Size: Select an existing vial size from the list (3) or add a new vial size by selecting Add New (4) and entering the vial size (5). Select Enter (6) to save the new vial size to the list. Select the vial size from the list.

Q

Dosage: Select an existing dosage from the list (3) or add a new dosage by selecting Add New (4) and entering the dosage (5). Select Enter (6) to save the new dosage to the list. Select the dosage from the list.

Q

Weight Range: Enter the weight range identified on the contrast package insert.

Q

Minimum Age: Enter the minimum age identified on the contrast package insert.

NOTE: A saved value can be deleted from the list by pressing the X button. Select Yes in the message window to confirm deletion. Deleting a value will also delete any saved contrast types using that value. 4.

Once a contrast name, concentration value, vial size, and dosage have been selected, select Save (7) to save the Contrast Type. Select Yes on the message window to confirm.

5.

Select OK to save all changes and exit Contrast Configuration. NOTE: If no changes were made, a message alerting the operator that a contrast type with those parameters already exists will display when attempting to save the contrast type. Select OK to close the message window. Edit a parameter to save the edited contrast type or select Cancel to return to the Contrast Configuration screen without making any changes.

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MEDRAD® MRXperion Prefilled Syringe Adapter

7 4

3 2

5

6 Figure 2 - 3: Editing an Existing Contrast Type

2.2.3 Contrast Type Management Q

When two or more contrast types have been saved, the order can be changed by using the Move Up and Move Down buttons on the Contrast Configuration screen.

Q

To delete a saved contrast type, select the Contrast Type on the Contrast Configuration screen and select Delete. Select Yes to confirm deletion.

Operation Manual

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3 - 13

Preparing for an Injection, Arming, and Injecting For complete operational information, warnings, and cautions, please refer to the MEDRAD® MRXperion MR Injection System operation manual.

WARNING Biological Contamination Hazard - Serious patient and/or worker injury or death may result. Q

Properly discard contrast and saline containers and disposable items after use (refer to disposable label for specifics), or if there is any possibility that contamination may have occurred.

Q

Do not reuse single-use fluid (contrast and saline) sources. Refer to the fluid source manufacturers’ instructions for use.

Q

Re-using contrast and saline containers for more than one procedure may result in biological contamination. Discard contrast and saline containers after using syringes for a single procedure.

Q

Syringes and tubing sets from Bayer are for single use only.

Q

Use of the system is intended to be consistent with contrast package labeling.

Air Embolization Hazard - Serious patient injury or death may result. Q

Expel all trapped air from the syringe(s), connectors, tubing, and catheter before connecting the system to the patient.

Q

To minimize air embolization risks, ensure that one operator is designated the responsibility of filling the syringe. Do not change operators during the procedure. If an operator change must occur, ensure that the new operator verifies that the fluid path is purged of air.

Q

To minimize the possibility of inadvertent aspiration and injection, ensure the patient is disconnected from the injector when using the forward and reverse piston controls.

Patient injury could result if syringe is not properly engaged. Q

Do not load or inject unless the syringe is properly engaged.

Patient or operator injury may result from fluid leads or syringe or tubing ruptures. Q

Ensure that the fluid path is open and use disposables that are rated to the set pressure limit. An occlusion in the fluid path and/ or use of syringes or tubing rated below the set pressure limit may result in leaks or ruptures.

Environmental Contamination Hazard - Serious patient injury and/or worker injury or death may result. Q

Follow aseptic technique when handling syringe and connector tubing components. Specifically, maintain sterility of all syringe and connector tubing components.

Q

Do not disassemble any syringe or connector tubing components. Do not remove the plunger from the syringe.

Q

Visually inspect contents and package before each use. Do not use if sterile package is opened or damaged.

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MEDRAD® MRXperion Prefilled Syringe Adapter

3.1 Control Room Preparation 1.

Select Fluids from the informatics panel on the left side of the Home screen. The Information screen will display.

Figure 3 - 1: Select Fluids on the Home Screen 2.

On the Fluid A tab (1) on the Information screen, select the Source Type field (2).

3.

Select a configured contrast from the list on the right side of the screen (3). Once a contrast is selected, the compatible PFA will display (4). For more information about contrast configuration, refer to "Section 2.2 - Contrast Configuration".

4.

If a PFA is not needed for the injection, uncheck the “Use Prefilled Syringe with Adapter (PFA)” check box (5) or install the contrast syringe. This will disable the additional PFA indicators (4). NOTE: When PFA Feedback is enabled, “Use Prefilled Syringe with Adapter (PFA)” is checked by default. See "Enabling Prefilled Syringe Adapter (PFA) Feedback" for more information.

1

3 2

5

4 Figure 3 - 2: Information Screen 5.

Select OK to save changes and return to the Home screen.

Operation Manual

6.

3 - 15

The Home screen will now show the compatible PFA to use with the selected contrast type (if PFA Feedback is enabled).

Figure 3 - 3: Compatible PFA Recommendation on Home Screen 7.

When a PFA is installed on the injector, the PFA Status Indicator (1) on the Home screen will show the PFA installed on Side A.

1

2

Figure 3 - 4: PFA Status Indicator on Home Screen: Incorrect PFA Installed NOTE: If a user installs a PFA that is not compatible with the selected contrast type, the compatible PFA will be shown (2) and a message will appear that says “Incorrect adapter installed. Please install the [compatible] adapter.” Install the compatible PFA, then select OK to proceed.

Figure 3 - 5: PFA Status Indicator on Home Screen: Incorrect PFA Installed