ACIST CVi and CMS2000 and E2000Voyager Contrast Delivery System User Manual Rev 02 Jan 2010

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Table of Contents Table of Contents

Information & Warnings ...v Contract Information ... v Contact and Ordering Information... v

About this manual ...vi Product Definition... vi Intended Use... vi Disclaimers ... vi IntendedUse/Indication ...viii Contra-indications ...viii

Warnings ...viii AIR COLUMN DETECT SENSOR ...viii AIR EMBOLISM ...viii AIR IN THE MONITORING LINE ...viii CABLES ...viii CATHETERS ... ix CLEANING... ix ELECTRICAL ISOLATION ... ix FLAMMABLE GASES ... ix HIGH FLOW RATE INJECTIONS ... ix INJECTION SYSTEM SETTING... ix MOUNTING SYSTEM... ix PROPER USE OF PATIENT KITS ... ix SHOCK HAZARD ... ix SYSTEM MESSAGES ... x

Precautions ...x ACCESSORIES ... x PATIENT TABLE (BED) RAIL MOUNT ... x CONTROL PANEL TOUCH SCREEN ... x ELECTROMAGNETIC/ELECTROSTATIC INTERFERENCE ... x EXCESSIVE INJECTIONS ... x EYE PROTECTION ... x INJECTION SYSTEM TEMPERATURE ... x LEAKAGE CURRENT... x LINE POWER ... x LOCK BUTTON ... x LOCKING WHEELS... xi P/N 900468-001 Rev. 02

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SALINE PUMP ... xi

Table of Contents

PREVENTATIVE MAINTENANCE ... xi PROPERTIES OF CONTRAST ... xi THE MOUNTED INSTRUMENT ... xi TRAINING ... xi

Section 1: System Overview...1 Introduction ... 1 System Components, Hardware ... 3 System Components, Disposables ... 5 Injector Head Electronics ... 7 The Computer System ... 7 Injection Motor Control ... 7 Saline Pump Control ... 7 Standby Button ... 7 Armed Light... 7 Control Panel Cable Connection... 8 Hand Controller Connection... 8 Touchscreen Display ... 8 ® The AngioTouch Hand Controller ... 8

The ACIST Angiographic Kit ... 9 Kit components include: ... 9 Contrast Media Requirements ... 9 Cables for Standard Power Supply ... 9 Cables for Siemens Axiom Artis Imaging System ... 10 Description of Accessory Items ... 10 Patient Kits ... 11 ACIST Pressure Transducer Cartridge ... 11 Pressure Monitoring Interconnect Cable... 11

Section 2: Installation ...13 Setup... 13 Installing the System ... 13 Mounting Configurations ... 13 Injector Head from Pedestal Cart to Patient table (bed) Mount (2 Options) ... 14 Transfer Injector Head from Patient table (bed) Mount to Pedestal Cart (2 Options) ... 15 Installing the CVi Adjustable Arm ... 16 Installing the CVi Utility Tray on all ACIST Systems ... 17 Installing the CVi Contrast Hanger on all ACIST Systems ... 17 Making Cable Connections ... 18 ii

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Standard Power Supply ... 18 Power Supply Configured for Use with Siemens Systems ... 20

Table of Contents

Section 3: System Setup...23 Section 4: About the Touchscreen...33 Contrast Usage Feedback Display ... 33 Select Injection... 35 Injection Parameters ... 35 Injection Parameter Ranges Table ... 36 Select Mode ... 36 Message Windows ... 38 Case Information... 38 System Info ... 39 Audible Indicators ... 39 X-Ray Interface Parameters ... 39 Imaging System Status and Control Lines ... 40 Status Output Lines ... 40 Input Control Lines ... 40

Section 5: Performing Patient Procedures ...41 Interface Devices ... 41 Operating the AngioTouch Hand Controller ... 41 Pre-Procedure Tasks ... 41 Pressure Monitoring ... 43 Refilling the Syringe with Contrast ... 45 Automatic Refill ... 45 Manual Refill ... 45 Purging Air from Contrast Media Components ... 46 KVO Injection ... 47 Resuming an Interrupted Case ... 47 Ending a Case when using a Model CL100H ... 48 Ending a Case when Using a Model CMS2000, Voyager, or CVi ... 48 Starting a New Case with the Existing Syringe ... 49 Starting Another Case with a New Syringe ... 49 System Shutdown ... 50

Section 6: System Maintenance ...51 Daily Cleaning ... 51 Clean the Sensors ... 51 Clean and Inspect the Chamber Sleeve ... 51

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Cleaning the Removable Backlight Cover ... 52

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Cleaning the Injector Head ... 53 Pressure Transducer Cartridge and Backplate ... 53 Decontamination ... 53 Daily Status Inspection and Prevention ... 54 Monthly Status Inspection ... 54 Annual Preventive Maintenance Inspection ... 54 Storage of Cart Mounted Systems ... 54

Section 7: Troubleshooting ...55 General Troubleshooting... 55 Emergency Shutdown Procedure ... 55 Problems with ACIST In-Line Pressure Monitoring ... 56 Frequently Asked Questions ... 57 Functional Errors... 57 Alert Messages ... 58

Section 8: Specifications ...69 System Control ... 69 Power Requirements ... 69 Electrical Leakage... 69 Safety and Sensor Checks ... 69 Injection Parameter Ranges ... 70 Saline Rate ... 70 Status Readouts ... 70 Program Control... 70 Height... 70 Weight ... 71 Cord Lengths ... 71 Specifications that Apply to UL Labeled Product ... 71 Transportation and Storage Requirements ... 71 Operating Environment Requirements... 71

Section 9: Voyager and CVi Supported Imaging Systems ...72 Section 10: Warranty Information ...73 CL100H/CMS2000 Limited Warranty ... 73 Voyager™ E2000 and ACIST CVi Limited Warranty... 74

Section 11 ...76 Symbols ... 76

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Information & Warnings

Contact Information USA

EUROPE

ACIST Medical Systems 7905 Fuller Road Eden Prairie, MN 55344 USA

ACIST Europe B.V. Becanusstraat 13 6216 BX Maastricht The Netherlands

ASIA PACIFIC, LATIN AMERICA, OR MEXICO ACIST Medical Systems 7905 Fuller Road Eden Prairie, MN 55344 USA

Customer Service EUROPE

USA

ASIA PACIFIC, LATIN AMERICA, OR MEXICO

Ordering patient kits

1-877-BRACCO.9

00800.2247.8387

Contact your local ACIST distributor

+ 31.43.328.1318 FAX Number

1-866-272-1619

Ordering systems and Call accessories 952-941-3507 or

+ 31.43.328.1329

Contact your local ACIST distributor

00800.2247.8387

Contact your local ACIST distributor

+ 31.43.328.1318

952-995-9300 for Representative nearest you FAX Number

FAX# 952-941-4648

+ 31.43.328.1329

Contact your local ACIST distributor

or FAX# 952-826-2895

Technical Support Service, Parts and Technical Support

1.888.670.7701

00800.2247.8387

or

or

952.941.3507

+ 31.43.328.1318

Contact your local ACIST distributor

or 952-995-9300

FAX Number

P/N 900468-001 Rev. 02

952-253-4524

+ 31.43.328.1329

ACIST Medical Systems, Inc.

Contact your local ACIST distributor

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Information & Warnings

Contact and Ordering Information

Contact Information

This manual is intended to guide you in the proper installation, use, and care of the ACIST® injection system. The manual contains information for all users of ACIST injection systems, whether you set the controls, direct its use, or interpret its results.

About this Manual

Information & Warnings

About this manual Also refer to the Instructions for Use provided with ACIST patient kits (the syringe, manifold, tubing, hand controller, etc.) for setup instructions and specific warnings and cautions.

Product Definition The ACIST injection system is an angiographic injection system that supplies radiopaque contrast media to a catheter at a user-determined variable flow rate and volume which can be instantaneously and continuously varied. The ACIST injection system is designed to comply with MDD/93/42 EEC and EN 60601-X series of safety standards for medical electrical equipment.

Intended Use The ACIST injection system is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Disclaimers ACIST Medical Systems reserves the right to change specifications and contents of this manual without obligation. Protected by one or more of the following U.S. patents and international counterparts: 5,515,851; 5,573,515; 5,800,397; 5,882,343; 5,916,165; 6,221,045; 6,344,030; 6,447,481; 6,626,862; 6,656,157; 6,673,048; 6,746,427; 6,752,789; 6,945,959; 7,101,352; 7,128,729; 7,169,135; D404,717; D412,205. Other U.S. and international patents pending. © Copyright 2007 by ACIST Medical Systems, Inc.

Manufactured by: ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344 USA Authorized European Representative: Medical Product Service GmbH Borngasse 20 35619 Braunfels, Germany AngioTouch and ACIST are trademarks of ACIST Medical Systems, Inc., registered in the United States. ACIST is a trademark of ACIST Medical Systems, Inc., registered in the United States.

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CAUTION:

Federal Law (USA) restricts the sale of this device by or on the order of a physician (or properly licensed practitioner).

Due to the type of procedures in which the ACIST System is used, (angiographic studies of human cardiovascular and central venous systems) or procedures in interventional radiology or in endovascular surgery), it is necessary that the ACIST system be operated by, or be under the immediate and direct supervision of a physician who is specifically trained in angiography and in the operation of this unit. System operation must be monitored at all times, and specific operational and mechanical integrity must be maintained to ensure patient safety. Support personnel must ensure that: •

All system connections are in place, secure, and functional

•

Proper grounding and isolation standards are maintained

•

Operational and calibration checks are made prior to each use of the system

•

Proper support equipment (for example, defibrillation unit, etc.) is on site for immediate response to patient distress.

PHYSIOLOGICAL PRESSURE TRANSDUCER (OPTIONAL) Attach the pressure transducer cartridge to the pressure transducer backplate before application of any pressure to the system. This prevents pressures from bursting the membrane and introducing air into the system. Note: Prior to recording physiological blood pressures with the transducer system, re-zeroing of the transducer is recommended to establish a clear baseline. (Changes in bed height, catheter hub position, fluid density, etc. can affect the baseline pressure.) Note: Prior to recording physiological waveforms with the transducer system, a saline flush is recommended to clear contrast from the tubing. (Any contrast in the tubing will damp pressure signals.)

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Information & Warnings

SAFE USE ACIST Angiographic Contrast Delivery System is designed to aid the physician in the injection of contrast media during angiography. It should be used with adequate radiographic imaging and where monitoring equipment for blood pressure and the electrocardiogram is available. Additionally, standard equipment for cardiopulmonary resuscitation and drugs for the treatment of contrast media-induced drug reactions should be present.

Caution and Safe Use

For proper operation, use only accessories and options provided by ACIST Medical Systems, which are designed specifically for the ACIST Angiographic Contrast Delivery System. This ensures compatibility with the injector. Do not use an accessory or option designed for another system on the ACIST Angiographic Contrast Delivery System.

Intended Use and Contraindiations

Information & Warnings

Intended Use/ Indication

The ACIST Injection System is intended to be used for the controlled infusion of contrast media for angiographic procedures.

ACIST Angiographic Contrast Delivery Systems are not intended for use as a long-

Contraterm infusion pump nor is it intended to be used to inject any agents other than indications contrast media. ACIST Angiographic Contrast Delivery Systems should not be used to inject substances into nonvascular body cavities. Any applications of the ACIST Angiographic Contrast Delivery Systems (other than those described in the user manual) are inappropriate and should not be attempted. Do not add any components (e.g., manifolds, connector tubing) into the ACIST disposable kits or in conjunction with the catheter. No valves or other manifolds may be placed in-line between the ACIST Angiographic Kit and catheter. The disposable kits are designed, manufactured, and tested for connection to catheters used in angiographic procedures. Do not use ACIST Angiographic Contrast Delivery Systems in the presence of flammable gases.

Please read and understand all the following warnings and precautions before proceeding with installation, setup and operation of the ACIST system.

Warnings AIR COLUMN DETECT SENSOR The ACIST System is equipped with an air column detect sensor. This sensor is designed to aid the user in the detection of air columns in the injection line, but it is not designed to replace the vigilance and care required of the operator in visually inspecting for air and clearing air from the entire patient kit and angiographic catheter. The air column detect mechanism is to be used in conjunction with and to complement the user’s other procedures for preventing air injections.

AIR EMBOLISM An air embolism can cause patient injury or death. Operator vigilance and care, combined with a set procedure, are essential to avoid injecting air and causing an air embolism. Before injecting, be sure to clear air from the entire patient kit and angiographic catheter. Make sure the exterior of the tubing is dry before inserting it into the air column detect sensor; if any fluid is present, they may inhibit the ability of the sensor to detect air.

AIR IN THE MONITORING LINE When using a blood pressure monitor, be sure to clear the monitoring line of all air to avoid producing an inaccurate blood pressure reading.

CABLES Be sure to plug each cable into the correct connector. Never touch the pins on the connector or cable (See “Making Cable Connections on Page 18”). Do not use the ACIST system if any worn cords or cables are detected. For replacement information, Contact an ACIST representative.

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CATHETERS Connections to the patient are to be made from commercially available catheters that have been approved for angiographic studies. For information on pressure settings and limits, refer to instructions provided by the catheter manufacturers.

ELECTRICAL ISOLATION Connections to the patient are physically isolated from all ACIST system power sources. Follow standard health care facility procedures to ensure that there is no degradation of system electrical performance.

FLAMMABLE GASES Do not use the ACIST system in the presence of flammable gases.

HIGH FLOW RATE INJECTIONS High flow rate injections can cause patient injury or death. Use extreme care when setting the flow rate to avoid unintentionally setting a high flow rate injection. When high flow rate injection is required, be sure to select a pressure setting that does not exceed the rated pressure of the selected catheter.

INJECTION SYSTEM SETTING Check the ACIST system settings before injection, and verify appropriateness of all injection parameters before injecting.

MOUNTING SYSTEM The system must be mounted using ACIST approved mounting assemblies, such as the Pedestal cart (see page 12) or the Patient Table (Bed) Rail Mount (see page 12). Use of non-approved mounting equipment may cause injury.

PROPER USE OF PATIENT KITS • • • • • • • •

Do not use the patient kits on more than one patient. Do not allow the disposables to sit, without use, for more than the maximum time recommended by the contrast manufacturer. Do not reuse the syringe kit with the CL100H system. Do not use the multi-procedural syringe kit with the CMS2000 or Voyager for more than five (5) procedures. Do not allow the syringe kit to sit loaded with contrast longer than the maximum time recommended by the contrast manufacturer. Do not use the multi-procedural syringe kit for more than five (5) procedures. Replace the automated manifold and hand controller kits after each procedure. Properly discard disposables in accordance with all local, state, and federal regulations, codes and directives.

SHOCK HAZARD Hazardous voltage exists within the ACIST system. To avoid shock, only trained, qualified service personnel should service the ACIST system. Always disconnect the system from line power before attempting to perform any maintenance. Never touch any pins on connectors or cables that have become disconnected from a live system. P/N 900468-001 Rev. 02 ACIST Medical Systems, Inc. ix

Information & Warnings

To avoid shock and prevent damage to the ACIST system, always disconnect it from line power before cleaning. Do not use excessive water when cleaning. Do not immerse any components in water. Be sure that the ACIST system is completely dry before applying power. For more information, see “System Maintenance,” starting on page 51.

Warnings

CLEANING

SYSTEM MESSAGES

Precautions

Information & Warnings

Respond appropriately to all system messages. If the message cannot be cleared, contact an ACIST representative. For more information, see “Troubleshooting,” starting on page 58.

Precautions ACCESSORIES For proper operation, use only accessories and options provided or specified by ACIST Medical Systems which are designed specifically for the ACIST system. This ensures compatibility with the device.

PATIENT TABLE (BED) RAIL MOUNT Failure to securely clamp the instrument to the patient table (bed) may result in serious injury. For optimal displacement of weight, the ACIST system should be mounted per the bed manufacturer’s recommended placement. Before mounting the ACIST system on the bed, consult bed specification to ensure that bed rails can support the system.

CONTROL PANEL TOUCH SCREEN Touch the touchscreen in one place only when programming. If the touchscreen is touched in two places simultaneously, a selection located at the midpoint between them may be inadvertently activated or selected.

ELECTROMAGNETIC/ELECTROSTATIC INTERFERENCE The ACIST system may fail to operate appropriately if exposed to high electromagnetic fields (which may be generated by sources such as radio transmitters and cellular phones), or to high levels of electrostatic discharge.

EXCESSIVE INJECTIONS When doing a large number of high pressure, high-volume injections or a very large number of low-pressure, low-volume injections, the manifold valve may begin to stick when resetting or opening. If this occurs, replace the patient kit.

EYE PROTECTION Always wear eye protection when using this device.

INJECTION SYSTEM TEMPERATURE When the ACIST system is brought in from extreme outside temperatures (heat or cold), allow it to stabilize at room temperature before use (approximately one hour).

LEAKAGE CURRENT If the chassis leakage current is above 100 microamperes, do not use the ACIST system. Contact an ACIST representative.

LINE POWER Check for proper voltage and frequency before plugging the ACIST system into an electrical outlet. Be sure the voltage selection plug on the power supply’s power entry module is in the correct position before plugging into a wall outlet.

LOCK BUTTON The ACIST system is locked to its mount when the locking knob is fully clockwise. The system should always remain locked to its mount except during transfer between mounts, e.g., when transferring from the patient table (bed) to the cart. For more information, see “Mounting Configurations” on page 13. x

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LOCKING WHEELS

The tubing must be properly installed in the injector head and the locking V-teeth engaged on the tubing for proper operation of the pump and system. (See page 28)

PRESSURE TRANSDUCER (OPTIONAL) Attach the pressure transducer cartridge to the transducer backplate before application of any positive pressure to the system. This prevents pressures from bursting the dome membrane and introducing air into the system.

PREVENTATIVE MAINTENANCE To ensure that your ACIST system is in optimal working condition, annual preventative maintenance is recommended. Contact ACIST Medical Systems for information on extended warranty options (see page 73).

PROPERTIES OF CONTRAST For correct function of the ACIST system, make sure that the contrast has its viscosity maintained between 26.6 centipoise and 4.6 centpoise for all functions at the temperature used.

THE MOUNTED INSTRUMENT Never lean, grab or place objects on the ACIST System. When transporting the system, guide it using the pedestal cart handrail only. Do not grab or push on the system itself. Make sure safety latch knob is tightened in the clockwise rotation and the unit is secure on the cart. For power supplies that are off the patient table (bed) mount, be sure that the power supply is in the cart tray during transportation.

TRAINING ACIST Medical systems recommends instruction for all qualified persons prior to operating of the ACIST system. A certified ACIST Medical systems representative will conduct training.

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Precautions

SALINE PUMP

Information & Warnings

After moving the ACIST system using the pedestal cart, lock the wheels to prevent unintentional movement when the cart is stationary.

Information & Warnings

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Section 1: System Overview Introduction

• Control panel • Injector head • Cables Angiographic patient kits (also referred to as the “disposables”) provide the interface between the ACIST injection system and the angiographic patient catheter. Patient kits consist of several components including a hand controller, high pressure (injection) tubing, a syringe assembly, and a manifold assembly. For more information on the patient kits used with the ACIST injection system, see page 11. The patient kits are sold separately and can be ordered from your ACIST distributor. This document is designed to orient lab personnel in setting up, using, and troubleshooting the ACIST injection system. Each part of the system is described in detail in this manual. Step-by-step procedures for using the system are also presented.

A More Detailed Look The ACIST injection system contains a motor-driven pump that delivers contrast media to a patient catheter. You can control the flow rate of the contrast media using a user-actuated proportional control device–the AngioTouch® Hand Controller. The hand controller enables you to provide variable or fixed rate control when dispensing contrast media. When using the variable rate feature, the system allows you to vary the flow rate of the contrast media from the injector while simultaneously observing the angiographic procedure on a angiographic monitor. Before the system is used, the patient kit disposables are loaded onto the injector and the system is prepped with contrast and saline. A touchscreen control panel allows you to uniquely configure the various injection parameters. The ACIST CMS2000, Voyager and CVi injection systems include disposables that are designed to be used for multiple procedures. A single syringe can be used in up to five cases. This reduces kit costs and saves contrast that would normally be discarded at the end of each procedure. The ACIST Voyager and the ACIST CVi injection systems are able to synchronize with certain X-ray imaging systems from Siemens, Toshiba, GE, and Philips. (For specific models and series, refer to Section 11. When interfacing to Siemens X-ray systems, a special Siemens power supply is required (see “Making Cable Connections” on page 18). P/N 900468-001 Rev. 02

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Section 1 System Overview 1

ACIST System Overview

• Power supply

Introduction

The ACIST® injection system is an angiographic injection system used in interventional cardiology, radiology, and vascular surgical procedures. The ACIST injection system supplies radiopaque contrast media to a catheter at a rate that can be instantaneously and continuously varied by the user. The ACIST injection system contains the following primary components:

System Components

ACIST System Overview

System Components, Hardware

3. Standby button

2. Armed light 1. LCD Touchscreen Display 12. Universal or CVi Contrast Hanger

4. Saline bag holder 13. Air Column Detect Sensor 11. Contrast Sensor 5. Saline Pump 10. Syringe Valve Sensor 14. Luminescent Backlight

6. Injector Head

15. Manifold clip and sensor

9. Syringe mounting chamber

16. Pressure Transducer backplate and disposable cartridge

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7. Cables

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1. Control Panel with LCD Display This is an interactive screen used to control injection parameters and use of the device. This screen can be calibrated during setup if needed.

4. Saline bag holder For hanging the saline bag. 5. Saline (peristaltic) pump Controls the flow of saline into the patient. 6. Injector Head: The part of the device that contains the electroics, including the computer system, the injection motor control, saline pump control, and the control panel. 7. Cables: Used to connect the various components of the system 8. Power supply: The power supply supplies power to the ACIST System, and provides electrical safety isolation between the main power and the ACIST System. 9. Syringe mounting chamber The mounting chamber has demarcations to assist you in determining the amount of contrast present in the syringe. 10. Syringe valve sensor (Located on top of the mounting chamber; connection is plugged in underneath) Detects if the system is ready to inject contrast to the patient. 11. Contrast sensor Detects if contrast remains for filling operations. 12. Universal or CVi contrast hanger Holds the contrast container. 13. Air column detect sensor An ultrasonic detection device used to aid the user in detecting and preventing air from being introduced into the patient. NOTE: The air column detect sensor is not a substitute for user vigilance. 14. Luminescent back light Located behind the syringe and disposable, the lighting facilitates visual air column detection. 15. Manifold clip and sensor Automatically switches between high and low pressure ports eliminating the need to switch manifold stopcocks. Ensures that the patient blood pressure is monitored any time fluid is not being dispensed (when using a pressure transducer). 16. Pressure Transducer Backplate and Disposable Cartridge (Optional) Used for pressure measurement when mounted in the backplate. P/N 900468-001 Rev. 02

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Section 1 System Overview 3

ACIST System Overview

3. Standby button When the Standby button is depressed, the system is immediately disabled. Pressing the Standby button again reverses the action.

System Components

2. Armed light A green light on the top of the control panel that indicates the system is armed and ready to inject. (Note: On some systems, the armed light is on the right side of the control panel.)

System Components

ACIST System Overview

System Components, Disposables

17. Contrast Container

25. Hand Controller

18. High Pressure (Injection) Tubing

24. Hand Controller Connection

26. Stopcock 23. Saline Bag 19. Automated Manifold

20. Contrast injection syringe

22. Saline Tubing 21. Disposable Pressure Transducer Cartridge

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17. Contrast container Contains the contrast media. 18 High pressure (injection) tubing Connects with patient catheters for contrast or saline injection. 19. Automated Manifold: Regulates the distribution of contrast media and saline.

22. Saline tubing Carries saline from the saline bag. 23. Saline bag For flushing the system and catheters through the use of the saline pump. 24. Hand controller connection Connects the hand controller to the touchscreen 25. Hand controller: The device used to inject contrast and to dispense saline. 26. Stopcock: Regulates the flow of fluids to the patient.

CAUTION: Never mix and match hardware components from different product models. Each model’s components are designed to work together as a set. In addition to the manufactured date label, newer model ACIST hardware components also will carry this label for easy identification:

The exception to this rule are the CVI Adjustable Arm, the CVi Utility Tray and the CVi Contrast Hangar. Instructions for installing these components on pages 16 and 17.

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ACIST System Overview

21. Disposable Pressure Transducer Cartridge

System Components

20. Contrast Injection Syringe The contrast syringe is a self-purging syringe and has one port for filling of contrast and purging of air, and a second port for injection of contrast.

The CL100H disposables are designed to be used per procedure and this injection system does not have synchronization capability.

Available Models

ACIST System Overview

Available Models •

CL100H: This is an early model that is no longer available for sale.

•

CMS2000: The ACIST CMS2000 system is designed for use in cardiac procedures to inject contrast into the patient’s vasculature. This model does not synchronize with any X-ray system

•

VoyagerTM E2000: The ACIST Voyager E2000 is designed for use in peripheral vascular procedures to inject contrast into the patient’s vasculature.This model does synchroize with certain Xray systems. For specific models and series, refer to Section 9. Note: Syrchronization is only possible provided the proper x-ray interface cable is also purchased and installed with the Voyager E2000.

•

ACIST CViTM: The latest model available from ACIST Medical Systems, the ACIST CVi combines the capabilities of the CMS2000 and the Voyager E2000 on the same device. The ACIST CVi may function in either in cardiac or peripheral modes Peripheral mode provides x-ray sychronization feature. For specific models and series of x-ray systems, refer to Section 9. Note: Synchronization is only possible provided the proper x-ray interface cable is also purchased and installed with the ACIST CVi.

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