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ACIST | CVi® Contrast Delivery System User’s Guide Bracco Group 901418-003,01 2019-08 English (USA)
Proprietary Information Notice This document contains information proprietary to ACIST Medical Systems, Inc. All rights reserved. Patents: acist.com/patents 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. ©2019 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, ACIST | CVi, and AngioTouch are registered trademarks of ACIST Medical Systems, Inc. ISOVUE is a registered trademark of Bracco Diagnostics, Inc. DisCide ULTRA is a registered trademark of Palermo Healthcare. LogiCal and Smiths are registered trademarks of Smiths Group PLC. Other trademarks are the property of their respective owners.
Contact Information Website
acist.com
USA
ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344 USA Technical Support Tel: 1 888.670.7701 or 1 952.941.3507 Fax: 1 952.253.4524 [email protected]
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Contents 1
2
Training... 15 X-Ray Cable... 15 Symbol Definitions... 16
Introduction
Intended Use... 5 Contraindications... 5 Requirements for Use... 5 Aseptic Technique... 6 About This User’s Guide... 6 Manual Conventions... 7
3
System Description
4
Setup
5
Perform an Injection
Warnings, Cautions, and Symbol Definitions
Warnings... 9 Aseptic Technique... 9 Air Embolism... 9 Air in the Monitoring Line... 9 Air Column Detect Mechanism... 9 Disconnect Before Flushing Air... 10 Use of Patient Kits... 10 Cables... 10 Catheters... 10 Cleaning... 10 Closed Stopcock... 11 DEHP (Phthalate)... 11 Electrical Isolation... 11 Emergency Shutdown... 11 Flammable Gases... 11 High Flow Rate Injections... 11 Injection System Setting... 11 Mounting System... 11 Residual Contrast... 11 Shock Hazard...11 System Messages... 12 Safe Use of Equipment... 12 Cautions... 13 Accessories... 13 Bed Rail Mount... 13 Cleaning... 13 Control Panel Touch Screen... 13 Electromagnetic/Electrostatic Guidance... 13 Excessive Injections...14 Eye Protection... 14 Injection System Temperature... 14 Leakage Current... 14 Line Power... 14 Lock Button... 14 Locking Wheels...14 Mixing Hardware Components... 14 Mounted System... 14 Pressure Transducer... 14 Preventive Maintenance... 15 Removing the Contrast Spike... 15 Rx Only... 15 Saline Pump... 15
ACIST | CVi® System User's Guide 901418-003,01 2019-08
Introduction... 19 System Hardware... 20 Power Supply... 21 Injector Head... 22 Mounting... 22 Audible Indicators... 24 Touchscreen Functions and Sample Injection Images... 24 Flow... 24 Volume... 24 Pressure... 24 Rise Time... 25 Select Injection... 25 Patient Kits... 28 Select Mode... 28 End Case... 28 System Messages Area... 28 BT2000 Manifold Kit... 29 AT P54 and AT P65 AngioTouch Kits... 29 A2000 Syringe Kit... 30 Setup Overview... 32 Power On... 32 Prepare the Contrast Container... 33 Load the Syringe Assembly... 34 Load Contrast... 34 Load Saline Tubing Assembly... 37 Purge the Tubing... 39 AngioTouch Hand Controller Setup... 40 Connect the Patient Catheter... 41 Zero the Pressure Transducer... 41 Adjust Parameters Based on Physician Preference... 43 Arm the Injector... 44 Inject Contrast... 44 Large Injections... 44 Disarm the Injector... 44 Automatic and Manual Refills... 44 Perform Contrast Purge... 45 Perform Saline Flush using 0.9% Normal Saline... 45 X-Ray Sync (Optional)... 45 Flush Saline Using the Hand Controller... 45 Standby... 46
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6
End a Case
7
Supplementary Procedures
8
Injection Does Not Start... 70 Power Failure... 70 Troubleshooting Hemodynamic Issues... 71 Zero Fluctuations... 71 Cannot Obtain Zero or Lose Zero Before Procedure... 72 Waveform Dampened... 72 System Messages... 73
End the Case... 47 End Case... 47 If Beginning a New Case with the Same Syringe... 47 If Using a New Syringe... 48 If Final Case... 49 Emergency Case... 49 General Cleaning Instructions... 51 Cleaning / Disinfection Procedure... 52 Monthly Inspection... 54 Annual Preventive Maintenance... 54 Storage of Cart-Mounted Systems... 54 Transfer the Injector Head to/from a Pedestal Cart... 55 Cabling... 56 Connect the Injector Head Cable... 56 Connect the Control Panel Cable... 56 Connect the X-Ray Interface Cable on Standard Systems (Optional)... 57 Connect the X-Ray Interface Cable on Siemens-Ready Systems (Optional)... 58 Plug In the Power Supply... 59 Mount the Power Supply on a Cart (Optional) . . 60 Recalibrate Control Panel Screen... 61 Change the Display Language and Pressure Units... 61 Display Language... 61 Calculate Parameters from Patient Weight... 62 Resume an Interrupted Case... 62 Pressure Units... 62 Change Color Scheme... 63 System Info... 63 Keep Vessel Open (KVO) Injection (Optional) . . . 63 KVO Injection... 63 KVO Rate... 63
9
Specifications
Load Rate... 81 Saline Rate... 81 Contrast Injection Parameters... 81 Cardiac procedure mode... 81 Peripheral procedure mode... 81 Pedestal Cart Dimensions... 82 Accuracy... 82 Weight... 83 Environmental Limits... 83 Transportation... 83 Power Supply... 84 Patient Kits... 84 Standard... 84 Power cord... 84 Electrical Leakage... 84 Hemodynamic Transducer... 85 Supported Imaging Systems... 85 UL Approval... 86
10 EMC Tables
EMC Requirements... 87
11 Limited Warranty
Troubleshooting
Frequently Asked Questions... 65 Troubleshooting the CVi System... 67 Air Column Detected... 67 Contrast Empty/No Contrast... 67 Hand Controller Calibration Failed... 68 Pressure Limit Exceeded... 68 Standby!... 68 Manifold Valve Open... 68 Manifold valve failed to close n times using current syringe. Use new syringe?... 69 Manifold Valve Open Conditions Requiring Syringe Replacement... 69 Syringe Valve Closed... 69 Syringe Valve Open... 70
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1
Introduction
Intended Use
The ACIST | CVi® Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures. The ACIST | CVi® Contrast Delivery System is specifically indicated for use in angiographic procedures for the delivery of ISOVUE® (iopamidol injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of ten (10) hours. The Syringe Kit must be discarded after six (6) patient procedures. The Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The ACIST | CVi® Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
Contraindications
The ACIST | CVi® Contrast Delivery System (CVi system) is not intended for use as a long-term infusion pump. The system is not intended to be used to inject any agents other than contrast media. The system should not be used to inject substances into nonvascular body cavities.
Requirements for Use
For safe use and optimal operation of the CVi system, observe the following guidelines: • Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. • Use only accessories and options provided by ACIST Medical Systems, which are designed specifically for the CVi system. This ensures compatibility with the injector. Do not use an accessory or option designed for another system on the CVi system. • The CVi system is designed to aid the physician in the injection of contrast media and 0.9% normal saline during angiography. The system should be used with adequate radiographic imaging, and where both blood pressure monitoring equipment and an electrocardiogram are available. Standard equipment for cardiopulmonary resuscitation and drugs for the treatment of contrast-media-induced drug reactions should be present. • It is necessary that the CVi 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
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Aseptic Technique
1 Introduction
monitored at all times, and specific operational and mechanical integrity must be maintained to ensure patient safety. • Support personnel must ensure that: ӽӽ All system connections are in place, secure, and functional. ӽӽ Proper grounding and isolation standards are maintained. ӽӽ Operational and calibration checks are made prior to each use of the system. ӽӽ Proper support equipment (for example, a defibrillation unit) is on site for immediate response to patient distress.
Aseptic Technique
Employ proper aseptic technique in the handling and use of all patient kits. Sterile openings must be handled with care to ensure contact with only sterile connections or a disinfecting cap. The use of gloves is preferred but not required.
About This User’s Guide
This User’s Guide provides instructions for setting up and using the CVi system. It includes the following sections: Section
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Purpose
1
Introduction
2
Warnings, Cautions, and Symbol Definitions
3
System Description
4
Setup
5
Perform an Injection
6
End a Case
7
Supplementary Procedures
8
Troubleshooting
9
Specifications
10 11
EMC Tables Limited Warranty
Identifies the purpose and structure of this guide. Users must read and understand this section thoroughly before using the CVi system. Provides an overview of the system, its components, and the touchscreen interface. Describes the steps necessary to set up a new case. Describes the steps for performing a contrast injection with the CVi system. Describes the steps for ending a case and, if desired, starting a new case or shutting down the system. Provides instructions for cleaning, maintenance, and infrequently used options Provides answers to frequently asked questions, as well as a list of system messages. Provides technical specifications for the CVi system. Provides EMC tables. Describes the limited warranty for the CVi system.
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1 Introduction
Manual Conventions
Manual Conventions
This manual uses the following conventions: Note Notes are used to highlight important information from the rest of the text. Tip Tips are useful information that may make tasks easier to accomplish. Important Information marked as important is vital to the proper operation of the system. 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 can cause serious injury or death.
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1 Introduction
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Warnings, Cautions, and Symbol Definitions Read this entire user guide prior to using the CVi system and patient kits to ensure proper understanding and use. Operate the device only in accordance with this user guide to ensure safe and effective use. Upon arrival, inspect all packaging and the delivered items for signs of damage that may have occurred during transportation. If any item appears damaged, contact an ACIST service representative.
Warnings
The following warnings refer to hazards that can cause serious injury or death. Please read and understand all the following warnings before proceeding with installation, setup, and operation of the CVi system.
Aseptic Technique Contamination of patient kits or the contrast container septum presents a risk of serious patient injury due to infection. Aseptic technique must be employed. If suspected contamination has occurred, replace the affected item.
Air Embolism An air embolism can cause patient injury or death. Operator vigilance and care, along with a defined procedure, are essential to avoid injecting air and causing an air embolism. Before injections, clear all air from the entire patient kit and the angiographic catheter. Make sure that the exterior of the tubing is dry before inserting it into the air column detect sensor. If any fluid is present on the tubing's exterior surface, the sensor may be unable to detect air.
Air in the Monitoring Line Clear the monitoring line of all air to avoid producing an inaccurate blood pressure reading.
Air Column Detect Mechanism The CVi system is equipped with an air column detect sensor. The air column detect sensor cannot detect air in the patient catheter, the stopcock, or the patient tubing past the sensor. This sensor is designed to aid the user in the detection of air columns in the injection tubing, 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. ACIST | CVi® System User's Guide 901418-003,01 2019-08
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Warnings
2 Warnings, Cautions, and Symbol Definitions
Disconnect Before Flushing Air When flushing air, be sure the tubing is disconnected from the patient.
Use of Patient Kits ACIST-provided patient kits are designed, manufactured, and tested for connection to catheters used in angiographic procedures. Failure to observe the following guidelines can result in patient injury or equipment damage: • Do not add any components to the patient kits or in conjunction with the catheter. • No valves or other manifolds may be placed inline between the patient kit and the catheter. • Do not use the single use kits on more than one patient. • Do not allow any patient kit loaded with ISOVUE (iopamidol injection) contrast media to sit unused for more than 10 hours. • Do not use a syringe kit for more than six cases. • Dispose of all single use components, including the saline bag, Manifold Kit, and AngioTouch Hand Controller Kit after every case. • Properly discard patient kits in accordance with all local, state, and federal regulations, codes, and directives.
Cables Be sure to plug each cable only into the connector designed for it. To avoid the risk of electric shock, never touch the pins on the connector or cable. Do not use the CVi system if any worn or damaged cords, cables, or connectors are detected. For replacement information, contact an ACIST representative.
Catheters Patient connections must be made using commercially available catheters that have been approved for angiographic studies. The system pressure limit should not be set higher than the rated pressure limit of the catheter. For information on catheter pressure settings and limits, refer to the instructions provided by the catheter manufacturer. The CVi system was tested for use with 4 Fr–7 Fr catheter sizes. When using catheters 5 Fr or smaller with injection flow rates > 12 ml/s, the system may reduce the flow rate to prevent Pressure Limit while providing selected volume, or the system may Pressure Limit and stop the injection. To obtain the desired imaging outcome in the event of Pressure Limit, the user must either reduce the selected flow rate or use a larger size catheter to complete the injection.
Cleaning • To avoid the risk of electric shock, and to prevent damage to the CVi system, always disconnect it from line power before cleaning. • Do not use excessive water when cleaning. • A disinfecting cap must be properly placed onto the multi-use syringe before cleaning. • Do not immerse any components in water. Be sure that the CVi system is completely dry before applying power.
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Warnings
Closed Stopcock Never inject with the stopcock closed.
DEHP (Phthalate) Testing has shown that patient DEHP exposure for adults, children and infants are below levels identified with potential risk of toxicity to reproduction. Physicians should, however, weigh the benefit against the risk when considering use of this product in children and pregnant or nursing women.
Electrical Isolation Connections to the patient are physically isolated from all CVi system power sources. Follow facility procedures to ensure that there is no degradation of CVi system electrical performance.
Emergency Shutdown In the case of power blackouts, power brownouts, or voltage surges resulting in abnormal system operation of any kind, immediately turn off the power switch and detach from the patient.
Flammable Gases Do not use the CVi system in the presence of flammable gases.
High Flow Rate Injections Use extreme care when setting the flow rate. High flow rate injections can cause patient injury or death. When a high flow rate injection is required, select a pressure setting that does not exceed the catheter's pressure rating. The maximum pressure rating of the CVi system is 1200 psi.
Injection System Setting Check the CVi system settings before injection, and verify the appropriateness of all injection parameters before injecting.
Mounting System The use of non-approved mounting equipment can cause injury. Mount the CVi system using only mounting assemblies approved by ACIST Medical Systems.
Residual Contrast Performing a saline flush following injection of contrast media will dispense residual contrast from the patient line to the patient. If it is suspected that such residue may adversely affect the patient, additional injections of contrast or saline should not be performed. Shock Hazard Hazardous voltage exists within the CVi system. To avoid the risk of electric shock, only trained, qualified personnel should service the CVi system. Disconnect the system from the power source before service. Do not touch the pins on the connectors or the cables.
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Warnings
2 Warnings, Cautions, and Symbol Definitions
System Messages Respond appropriately to all system messages. If the message cannot be cleared, contact an ACIST representative.
Safe Use of Equipment • No modification of equipment is allowed. • The CVi system may only be interfaced with X-ray equipment that is certified to be in compliance with IEC 60601-1, third edition. • To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth ground. • To avoid the potential for electric shock to the patient, X-ray equipment used in conjunction with the CVi system must provide two means of patient protection. • To avoid the potential for electric shock to the patient, do not touch the patient while making connections to the injector head or to the power supply. • To avoid the potential for electric shock, do not touch the patient and the X-ray interface connector pins simultaneously. • To meet the defibrillator protection specified, the CVi system must be used only with accessories (including transducers and adapter cables) that are specified by ACIST Medical Systems. • Never disconnect a CVi system from the mains power source while the main power switch is on. Make sure the main power switch is turned off before disconnecting. • The CVi system should not be used in rooms containing magnetic resonance imaging (MRI) equipment.
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Cautions
Cautions
The following precautions refer to hazards that could result in injury to the patient or user or damage to the CVi system or other equipment. Read this section carefully.
Accessories For proper operation and to ensure equipment compatibility, use only accessories and options provided or specified by ACIST Medical Systems for use with the CVi system.
Bed Rail Mount Failure to securely clamp the CVi system components to the bed rail may result in serious injury or equipment damage. Mount equipment according to the bed manufacturer’s recommendations. Before mounting the CVi system on a bed rail, consult the bed manufacturer's specifications to make sure that the rail can support the system's weight.
Cleaning To avoid equipment damage: • Do not apply bleach or other cleaners except as specified. Damage and degradation of the system and its parts can result if such solutions are applied. • Do not apply cleaning solutions to the rubber membrane of the pressure transducer backplate. Applying cleaning solutions to the rubber backplate can degrade the transducer, resulting in poor pressure waveforms.
Control Panel Touch Screen Touch the control panel screen in only one place at a time to avoid inadvertently activating buttons.
Electromagnetic/Electrostatic Guidance • The CVi system may fail to operate correctly if exposed to certain electromagnetic fields (for example, radio transmitters, cell phones), or if exposed to high levels of electrostatic discharge. To avoid adverse events due to electromagnetic disturbances, ensure the system is properly connected to hospital ground and not subjected to electromagnetic/electrostatic environments that exceed compatibility limits as defined in IEC 60601‑1‑2. Refer to the compatibility ranges in Chapter 10. • The use of accessories, transducers, or cables other than those specified and provided by ACIST Medical may result in increased electromagnetic emissions or decreased electromagnetic immunity of the CVi system. • The CVi system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the system should be observed prior to patient use to verify normal operation in the configuration in which it will be used. • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) from any part of the CVi system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
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Cautions
2 Warnings, Cautions, and Symbol Definitions
Excessive Injections When performing a large number of either high pressure, high volume injections or low pressure, low volume injections, the manifold valve may begin to stick when resetting or opening. If this occurs, replace the manifold kit.
Eye Protection Always wear eye protection when using the CVi system.
Injection System Temperature When the CVi system is brought in from extreme outside temperatures (hot or cold), allow it to stabilize at room temperature for approximately one hour before use.
Leakage Current If the chassis leakage current is above 100 µA, do not use the CVi system.
Line Power Before connecting the CVi system to an electrical outlet, check the power source for proper voltage and frequency.
Lock Button The CVi system is locked to its mount when the locking knob is tightened fully clockwise. The system should remain locked to its mount except during transfer between mounts (for example, transferring between a bed rail and a wheeled cart).
Locking Wheels To prevent unintentional movement of a CVi system that is mounted on a wheeled cart, lock the wheels.
Mixing Hardware Components Never mix and match hardware components from different injector system models. Each model's components are designed to work together as a set.
Mounted System Do not lean, grab, or place objects on the CVi system. When transporting the CVi system on the pedestal cart, follow these guidelines: • Make sure that the safety latch knob is tightened fully clockwise, and that the unit is secure on the cart. • Make sure that the power supply is secured to the mounting bracket during transport. • Guide the system using the cart handrail only. Do not push the CVi system. • For power supplies that are off the patient table (bed) mount, be sure that the power supply is in the cart tray during transportation.
Pressure Transducer To avoid bursting the dome membrane on the pressure transducer backplate and introducing air into the system, attach the disposable pressure transducer to the backplate before applying positive pressure to the system. 14 | English (USA)
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Cautions
Preventive Maintenance For optimal performance of the CVi system, annual preventive maintenance should be performed by an authorized ACIST Medical Systems representative.
Removing the Contrast Spike When removing patient kits, make sure the contrast spike is removed from the contrast container prior to opening the syringe chamber.
Rx Only Federal (USA) law restricts this device to sale by or on the order of a physician.
Saline Pump The tubing must be properly installed in the injector head and the rear tubing guide must be lowered onto the tubing for proper operation of the saline pump and the system.
Training All qualified personnel who will be operating the CVi system should be trained by a certified representative of ACIST Medical Systems.
X-Ray Cable To avoid damaging X-ray imaging equipment, make sure the connector on the X-ray imaging system is properly configured before the input cable is connected to the CVi system.
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Symbol Definitions
Symbol Definitions
2 Warnings, Cautions, and Symbol Definitions
The following symbols are used on the CVi system, patient kits, and throughout this manual: Symbol
Definition
Manufacturer, Date of manufacture Use-by date Batch code Catalog number Serial number Sterilized using ethylene oxide Sterilized using irradiation Do not resterilize Do not use if package is damaged Fragile, handle with care Keep dry Temperature limit Humidity limitation Atmospheric pressure limitation Do not reuse Consult instructions for use Caution Non-pyrogenic Alternating current
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Symbol Definitions
Symbol
Definition
Protective earth; protective ground Equipotentiality Non-ionizing radiation Packaging unit Defibrillation-proof type CF applied part Locking Unlocking Refer to instruction manual/booklet No pushing General warning sign Warning: electricity PHT DEHP
IP21
Contains or presence of phthalate: bis (2-ethylhexyl) phthalate (DEHP) Protection of equipment against ingress of solid foreign objects ≥ 12.5 mm diameter. Protection against access to hazardous parts with a finger. Protection against vertically falling water drops when equipment is tilted up to 15°. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. C-UL, US classification mark Do not tip No syringe Warning: explosive material
MR
MR Unsafe
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2 Warnings, Cautions, and Symbol Definitions
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3 Introduction
System Description The CVi system is an angiographic injection system used in interventional cardiology, radiology, or vascular surgical procedures utilizing an endovascular technique. The CVi system supplies radiopaque contrast media to a catheter at a user-determined variable flow rate that can be instantaneously and continuously varied. The CVi system contains a motor-driven pump that delivers contrast media to a patient catheter. The flow rate of contrast media from the injector to the catheter can be controlled with a user actuated proportional control: the AngioTouch® Hand Controller. The hand controller allows variable rate or fixed rate control when dispensing contrast media. When using the variable rate feature, the CVi system allows the user to vary the flow rate from the injector while simultaneously observing the angiographic procedure (for example, on a fluoroscope monitor). The hand controller and other components are provided in angiographic patient kits. The patient kits provide the interface between the CVi system and an angiographic patient catheter (not supplied by ACIST). If desired, blood pressure may be monitored through the system in conjunction with the lab's monitoring equipment. The CVi system is able to synchronize with certain X-ray imaging systems. See Supported Imaging Systems on page 85 for additional information. Synchronization is only possible provided the proper X-ray interface cable is also purchased and installed.
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System Hardware
System Hardware
3 System Description
The CVi system, installed on a pedestal cart or bed rail, includes three main hardware components: • Power supply • Injector head • Control panel System hardware also includes the following components: • Power and communication cables • X-ray synchronization cable (optional) • Pedestal cart (optional)
Control panel
Injector head Cables Pedestal cart
Power supply
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