ACIST EmpowerCTA Injector System User's Guide Sept 2009

Proprietary Information Notice This document contains information proprietary to ACIST Medical Systems, Inc. All rights reserved. Protected by one or more of the following U.S. patents and international counterparts: RE38,879; RE38,695; and 7,357,785. Other U.S. and international patents pending. No part of this document may be reproduced, transmitted, processed, or recorded by any means or form, electronic, mechanical, photographic or otherwise, nor be released to any third party without the written consent of ACIST Medical Systems, Inc. Copyright © 2001, 2009 ACIST Medical Systems, Inc. All rights reserved. The written and graphic product descriptions in this manual were effective at the time of printing. ACIST Medical Systems, Inc. reserves the right to change specifications and designs without prior notification. ACIST, EmpowerCTA, EmpowerSync, and IRiSCT are registered trademarks of ACIST Medical Systems, Inc. FASTLOAD is a trademark of ACIST Medical Systems, Inc.

Contact Information USA

ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344 USA Technical Services: 1-888-670-7701 or 952-941-3507 FAX: 952-253-4524 E-Mail: [email protected]

Europe:

ACIST Europe BV Renier Nafzgerstraat 114 6221 KL Maastricht The Netherlands Technical Services: 1 800 22478 387 or +31 43 354 5030 FAX: +31 43 354 5035

Asia Pacific Latin America Mexico

ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344 USA Technical Services: 952-941-3507 FAX: 952-253-4524

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Contents Proprietary Information Notice... ii Contact Information... ii

1

Introduction

1

Purpose of the Empower CTA® Injector System... 1 About this User’s Guide... 1 Manual Conventions... 2

2

Warnings, Cautions, and Symbol Definitions

3

Read this First!... 3 Warnings... 3 Cautions... 6 Symbol Definitions... 7

3

Basic Operating Procedures

9

System Overview... 9 System Installation... 9 Injector Components... 10 Remote Control... 11 Power Supply... 11 Label Printer... 11 Overview of the Basic Operating Procedures... 12 Power On... 13 Power Supply... 13 Remote Control... 13 Injector... 13 Features of the Injector Head and the Injector Head Control Screen... 14 Syringe Selection and Identification System... 14 Positions of the Injector Head... 15 Functions of the Injector Controller Screen... 16 Prepare the Patient... 19 Load and Fill the Syringes with Contrast and Saline... 20 Required Consumable Kits... 20 Preparation Needed... 22 How to Load Syringes... 23 How to Fill Syringes... 24 Remove Air from Syringes and Tubing... 26 900763-001,05

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Attach the Tubing... 26 Expel Air from the Syringes and Tubing... 27 Program the Remote Control... 29 Reading a Program... 29 Removing an Existing Program from the Main Screen... 30 Enter a New Program... 31 Test the Injection... 35 Perform the Injection... 36 Disconnect from the Patient and Remove the Syringe(s)... 38 Disconnect the Patient from the Injector System... 38 Remove the Syringes... 38 Clean Up and Storage... 40

4

Advanced Programming Procedures

41

Remote Control Main Screen... 41 Remote Control Program Screen... 42 Reading and Creating Programs... 43 Pressure Limit and Delay To Scan... 44 Examining and Selecting Existing Programs... 45 Modifying Existing Programs... 46 Saving and Deleting Programs... 47 Anatomical Identifiers... 48 The Program Lock Feature... 49 Using the Bracco Protocol Reference Guide... 50

5

System Configuration

53

The Setup Screen... 53 Changing the Audio Volume... 56 Enabling or Disabling the Delay to Scan Feature... 57 Enabling or Disabling the Test Injection Feature... 58 CT Contrast and Lot Code Setup... 59 CT Contrast and Lot Code Entry... 60 Creatinine and GFR Setup... 63 Creatinine Entry... 66 GFR Entry... 68

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Patient ID Setup... 70 Patient ID Entry... 71 Patient ID Entry (continued)... 72 Shutting Down the System... 73 Powering Off the Remote Control... 73 Powering Off the Injector System... 73 Help Feature... 74

6

Understanding Extravasation Detection

75

Suggested Techniques for Minimizing Extravasations... 75 Overview of the Extravasation Detection Accessory (EDA)... 76 How to Load and Place the Extravasation Detection Patch... 78 Read this First... 78 Load the Patch into the EDA Clip... 78 Place the Extravasation Patch on the Patient... 80 Detecting an Extravasation During an Injection... 82 Completing the Injection... 82

7

Using the IRiS Utility

83

Introduction... 83 IRiS Remote Viewer Navigation Instructions... 84 Reviewing Contrast Utilization... 88 12-Month Contrast Utilization... 88 Monthly Contrast Utilization... 89 Daily Contrast Utilization... 90 Reviewing Injector Utilization... 91 12-Month Injector Utilization... 91 Monthly Injector Utilization... 92 Daily Injector Utilization... 93 Injection and Patient Parameters... 95 Pressure Profile... 96 Reviewing EDA Utilization... 97 12-Month EDA Utilization... 97 Monthly EDA Utilization... 98 Daily EDA Utilization... 99

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8

CT Scanner Interconnect

101

Background... 101 Overview of Operation... 101

9

Limited Warranty

103

EmpowerCTA® Injector System Limited Warranty... 103

Appendix A - Glossary

105

Appendix B - Troubleshooting

109

Frequently Asked Questions... 109

Appendix C -Technical Specifications and EMC Tables

113

Component Specifications... 113 Overall System Accuracies and Ranges... 114 Regulatory Requirements... 115 EMC Tables... 117

Index

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Introduction

1

Introduction

Purpose of the Empower CTA® Injector System

The EmpowerCTA® Injector System (CTA Injector) is intended to be used to intravenously administer iodinated Contrast solutions followed by Saline into human patients who are undergoing diagnostic exams for Computed Tomography. It is not intended for any other use.

About this User’s Guide

This User’s Guide provides instructions for setting up and using the Empower CTA System. It includes the following sections:

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______________________________________________________________ CAUTION: Federal law (USA) restricts this device to sale, distribution, and use by, or on the order of, a physician. ____________________________________________________________________

Section

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Purpose

Section 1: Introduction

Identifies the purpose and structure of this user’s guide.

Section 2: Warnings, Cautions, and Symbol Definitions

Users must read and understand this section thoroughly before using the EmpowerCTA Injector.

Section 3: Basic Operating Procedures

Provides instructions for preparing and using the EmpowerCTA Injector for Computed Tomography diagnostic exams.

Section 4: Advanced Programming Procedures

Provides instructions for modifying and managing programs using the Program screen.

Section 5: System Configuration

Provides instructions for reviewing system information and changing system settings. Also explains how to use the online Help System.

Section 6: Understanding Extravasation Detection

Provides instructions for using the Extravasation Detection Accessory.

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Introduction

About this User’s Guide (continued)

Manual Conventions

Section

Purpose

Section 7: Using the IRiS Utility

Provides instructions for using the IRiSCT Viewer Application.

Section 8: CT Scanner Interconnect

Describes the EmpowerSync™, the CT scanner protocol that allows signals to be transmitted and coordinated between the CT scanner and the CTA Injector.

Section 9: Service and Warranty

Provides service and warranty information.

Appendix A: Glossary

Provides definitions of terms.

Appendix B: Troubleshooting

Provides answers to frequently-asked questions.

Appendix C: Technical Specifications and EMC Tables

Provides technical specifications for the Injector, Remote Control, and Extravasation Detection Accessory.

This manual uses the following conventions: ______________________________________________________________ Note

Notes are used to highlight important information from the rest of the text.

______________________________________________________________ ______________________________________________________________ CAUTION

Cautions alert the user to a possible hazard that may result in equipment damage or personal injury.

______________________________________________________________ ______________________________________________________________ WARNING

Warnings alert the user to a possible hazard that cause serious injury or death.

______________________________________________________________

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Warnings, Cautions, and Symbol Definitions

2

Warnings, Cautions, and Symbol Definitions

Read this First!

Before using the Empower CTA Injector System, please read this entire section and be certain you understand it fully. Failure to do so may result in serious injury to the patient, to the user, or may result in damage to the CTA Injector system or other equipment. If you have any questions after reading this section, please contact ACIST Medical Systems, Inc. Technical Services.

Warnings

The following warnings refer to hazards that can cause serious injury or death. Read this section carefully.

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•

The sole purpose of the EmpowerCTA Injector System is to intravenously administer iodinated Contrast solutions followed by Saline into human patients who are undergoing diagnostic exams for Computed Tomography. It is not intended for any other use. DO NOT use this equipment for any application other than its expressed purpose.

•

When operating with the EmpowerCTA Injector System, you must put only Contrast in the Contrast syringe and Saline in the Saline syringe. Failure to do so may lead to inadequate diagnostic results and potential injury to the patient.

•

This equipment is not for use in chemotherapy, drug infusion, or any other application for which it is not indicated.

•

The EmpowerCTA Injector System must be used properly to prevent the risk of an air embolism. Always fill the syringe with the Injector pointing fully upward. When the syringe has been filled to the desired volume, all the air should be purged from the syringe and coiled tubing with the Injector still in the fully vertical position. Failure to do so may lead to serious injury and /or death.

•

Never use the slow reverse, fast forward or fast reverse buttons on the EmpowerCTA Injector System (i.e., the buttons with downward and upward arrows shown above them), nor the Replace Syringe button on the Injector System, while the EmpowerCTA Injector System is connected to the patient.

•

In the event of a system malfunction, immediately turn off the EmpowerCTA Injector System and quickly disconnect the patient from the unit. Confirm that the system malfunction has been repaired before reconnecting the patient. Turn the system on, arm the injector and perform a test injection. If the system shows no further malfunction, reconnect the patient. If a fault message still exists and cannot be corrected and/or the injector is still malfunctioning, DISCONTINUE USE of the

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Warnings, Cautions and Symbol Definitions

EmpowerCTA Injector System until the problem is properly identified and solved. Contact ACIST for further assistance.

Warnings (continued) •

Exercise extreme caution when setting the flow rate on the Remote Control and/or the Injector Controller so as not to create an inadvertently high flow rate injection. PATIENT INJURY CAN RESULT FROM HIGH FLOW RATE VENOUS INJECTIONS. Be sure to review all program parameters and injection settings prior to arming and running the injector.

•

The EmpowerCTA Injector System is not MRI compatible and must not be used in magnetic resonance imaging (MRI) studies. Portions of the EmpowerCTA Injector System will respond dangerously to the very high magnetic fields associated with MRI scanners.

•

A risk of explosion exists if the EmpowerCTA Injector System is used in the presence of flammable anesthetics. It should never be operated when any flammable gases are present. This equipment is not suitable for use when a FLAMMABLE ANESTHETIC MIXED WITH AIR or OXYGEN or NITROUS OXIDE is present.

•

The EmpowerCTA Injector System has been proven to work properly with ACIST supplies. To prevent the risk of incompatibilities and equipment failures during procedures, use only syringes and connecting tubes supplied directly by ACIST or its authorized distributors.

•

After the FASTLOAD™ syringe has been filled with Contrast it should be used within a few hours. Once exposed to air, bacterial growth may occur. Always follow the Contrast and Saline manufacturer’s labeling for handling, loading, use, storage and disposal of their product.

•

To prevent transmission of infection, observe aseptic techniques when handling Contrast, Saline or any equipment or materials that contain or conduct the Contrast or Saline, including syringes, fill tubes, and intravenous administration sets. Never reuse any of these single-use items. Discard these disposable items using proper procedures for bio-hazardous waste.

•

To assure sterility, as well as to prevent spills or damage to the equipment, always inspect the packaging of the connecting tube and the syringe itself to verify that there are no broken seals or other signs of damage. If such conditions exist, do not use the syringe.

•

Spilled fluid can result in the possibility of electrical shock. Do not allow Contrast, Saline or other fluids to spill over the EmpowerCTA Injector System. Do not immerse any parts of the EmpowerCTA Injector System when cleaning. This could create a conductive path between metallic parts of EmpowerCTA Injector System and the patient.

•

Use the EmpowerCTA System only when connected to a proper electrical source. Plug the EmpowerCTA Injector and Remote Control directly into a grounded, hospital-grade electrical outlet. Do not use an extension cord. Do not use an adapter to plug the EmpowerCTA Injector System or Remote Control into a two-pronged, non-grounded outlet. Replace any worn or frayed wires immediately.

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Warnings, Cautions, and Symbol Definitions

Warnings (continued)

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•

The EmpowerCTA Injector System, as well as any other electrical equipment attached to the patient and/or catheter must be electrically isolated or properly grounded to prevent possible electrical shock.

•

Attempting to open any component of the EmpowerCTA Injector System can also result in electrical shock. Do not attempt to repair or modify any portion of the system. These units contain no user-serviceable parts. Only authorized ACIST service personnel should perform servicing of internal parts.

•

Administering intravenous Contrast or Saline with an Injector poses the risk of extravasation. As with any procedure that involves intravenous injection of a substance, proper technique can substantially reduce the incidence of extravasation. While the attending physician must always establish the specific technique, suggested precautions when using the EmpowerCTA Injector System can be found in Section 6.

•

Always instruct the patient to immediately notify the CT personnel of any pain or change in feeling that is experienced during the procedure.

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Warnings, Cautions and Symbol Definitions

Cautions

The following precautions refer to hazards that could result in minor injury or damage to the CTA Injector system or other equipment. Read this section carefully. •

Connect the EmpowerCTA Injector System only to an electrical source of the proper voltage and frequency as specified in Appendix C. If an incorrect voltage is used, the Injector System may be damaged when it is turned on.

•

When retracting the syringe plunger with the EmpowerCTA Injector System during Contrast or Saline filling or after the end of an injection, do not let a vacuum build in the syringe by leaving the EmpowerCTA Connecting Tube attached to the end of the syringe. In addition do not occlude the J-Tube (Fill Tube) or patient coiled tubing to the syringe. Failure to let the syringe properly vent when retracting the syringe plunger can cause the plunger to recoil forward when the Injector ram reaches the Replace Syringe position.

•

Dried Contrast may make removal of Luer fittings difficult. Do not let Contrast dry. Make sure Luer connection is not over tightened.

•

Rx only (USA): Federal law (USA) restricts this device to sale, distribution, and use by, or on the order of, a physician.

•

In the event of a loss of communications between the two systems, the Injector system will go to Monitor mode. An acknowledgement message will be displayed to denote the fault occurrence.

•

The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: »

Use of the accessory in the patient vicinity.

»

Evidence that the safety certification of the accessory has been performed in accordance to the appropriate IEC/EN 60601-1-1 harmonized national standard.

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Warnings, Cautions, and Symbol Definitions

Symbol Definitions

Symbol

Definition Patient Applied Part, Injector Head, Degree of protection against electric shock, Type BF

Potential equalization

Alternating current.

Protective earth ground.

Attention! Read the user’s guide before using.

Consult instructions for use.

On (power connection to line power).

Off (power disconnection to line power).

Patient Applied Part, Extravasation Detection Accessory, Degree of protection against electric shock, Type CF applied part.

Manufacturer.

Date of manufacture.

Serial number.

Catalog number.

CAUTION: Federal law (USA) restricts this device to sale, distribution, and use by, or on the order of, a physician.

Dangerous voltage.

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Warnings, Cautions and Symbol Definitions

Symbol Definitions (continued)

Symbol

Definition Explosion hazard.

Do not tip

European representative.

Contact for service

This product should be recycled and not disposed of as general waste (subject to WEEE annex IV resp. EN 50419). In accordance with European Union WEEE Directive 2002/96/EC, ACIST Europe BV will be fully responsible for the coordination, logistics, and costs of the WEEE process.

With respect to electric shock, fire, mechanical and other specified hazards, only in accordance with Medical Device listing to UL 2601-1/IEC 60601-11,CAN/CSA C22.2 No. 601.1-M90 (R1997), CAN/CSA C22.2 No. 601.1S1-94, CAN/CSA C22.2 No.601.1B-98 and EN 60601 Electrical Class I,Type BF Isolation rating, Injector, Type CF Isolation rating, EDA.

Compliance, European directive 93/42/EEC. Medical Device Directive.

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Basic Operating Procedures

3

Basic Operating Procedures

System Overview

The EmpowerCTA® Injector System is intended to deliver venous-side iodinated X-ray Contrast followed by a Saline chase for use in conjunction and/or interconnection with a computed tomography (CT) scanner. For instructions on the use of your particular scanner and its other related equipment, please consult the manuals provided with those devices or contact their respective manufacturers. The EmpowerCTA® Injector System has three primary components: •

Injector

•

Remote Control

•

Power Supply

Remote Control

Injector

Only an authorized and trained ACIST Medical Systems representative may install the EmpowerCTA Injector System.

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Basic Operating Procedures

Injector Components

The following illustration shows the parts of the Injector: Contrast Syringe Warmer

Contrast Syringe

Saline Syringe

Syringe Plunger

Syringe Ram Injector Controller Screen

Membrane Selection Buttons Injector Head

Pause or Run Pendant

EDA Cable

Hand Knobs

Extravasation Detection Accessory (EDA)

The Injector System includes the Injector with Injector Controller Screen, EDA, connection cables and syringe warmer. The Injector Controller Screen enables the user to initialize, fill, and purge the syringes. It also provides EDA status information and controls for starting/stopping the injection once parameters are defined using the Remote Control. Page 10 | EmpowerCTA® Injector System User’s Guide

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Basic Operating Procedures

Remote Control

The Remote Control is a network-enabled computer that runs the remote control application of the EmpowerCTA® Injector System. From the touchscreen of the Remote Control computer, the user can do the following: •

view the remaining fluid volume in each syringe;

•

use the Bracco Protocols to select pre-defined injection parameters;

•

access and use the IRiS CT utility;

•

access the SETUP options;

•

select a pre-defined program;

•

arm the system for injecting;

•

run an injection;

•

view the EDA status; and

•

print a label for the study (optional feature).

Power Supply

The power supply provides power for the injector and it provides communications between the Injector and the Remote Control.

Label Printer

The label printer is an optional component that connects to the Remote Control and prints a label that contains the Patient ID, Date, Time of Injection, Contrast Brand, Contrast Lot Number, GFR Value, Serum Creatinine Value, the amount of contrast injected, and the injection protocol (injection parameters for each phase).

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Basic Operating Procedures

Overview of the Basic Operating Procedures

To perform an injection using the EmpowerCTA® Injector System the user is required to perform the following ten steps. These steps are described in more detail in the subsections that follow: 1. Power On the system components. 2. Review the features of the Injector Head and Injector Head Control Screen. 3. Prepare the patient. 4. Load the syringes and fill with contrast and saline. 5. Remove all air from the syringes and tubing. 6. Program the Remote Control. 7. Arm, and then run the injection. 8. Print a label for the study (optional). 9. Disconnect patient and unload the syringes. 10. Power Off the system components.

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Basic Operating Procedures

Power Supply

Power On

Ensure the power supply is connected to the main power source and that the connecting cables to the Remote and to the Injector are secure. Verify that the PWR indicator light on the power supply is green.

Remote Control Ensure the power switch on the power supply for the remote control is on. The power switch for the remote control is located on the right underside of the Remote Control screen. Flip the rocker switch to turn on power to the Remote Control. The screen displays the touchscreen options and the ACIST logo.

Injector The power switch for the Injector is located on the right underside of the Injector Controller Screen. Flip the rocker switch to turn on power to the Injection System. The screen displays setup instructions.

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Basic Operating Procedures

Features of the Injector Head and the Injector Head Control Screen

Syringe Selection and Identification System Two color-coded syringe selection buttons on the injector controller switch the controls between the contrast and saline syringes. When one of the syringe selection buttons is selected a corresponding light illuminates to visually acknowledge which syringe piston is activated. Also, the selected syringe type (contrast or saline) displays on the injector controller screen. The buttons are clearly marked CONTRAST (orange membrane button) and SALINE (yellow membrane button) to reduce any confusion as to the content or purpose of the syringe selected.

Contrast LED on Injector Head

Saline LED on Injector Head

The selected syringe type displays on the injector controller screen

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