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acist cvi user manual
acist cvi user manual
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acist cvi user manual
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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. 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.
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. 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. 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.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. 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.
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. 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.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. 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.
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.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. 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. 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. If the message cannot be cleared, contact an ACIST representative. For more information, see “Troubleshooting,” starting on page 58.
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). 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: Page 16 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. 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. 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.) Page 18 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 4 Section 1 System Overview ACIST Medical Systems, Inc. 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. Section 1 System Overview 5 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. Page 20 The CL100H disposables are designed to be used per procedure and this injection system does not have synchronization capability. 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. 6 Section 1 System Overview ACIST Medical Systems, Inc. The injection motor amplifier provides a drive signal to the motor in response to a control voltage. Forward, reverse, and brake signals come from the computer, and a speed feedback signal from an optical encoder is used to control speed. These allow the computers to check motor speed, motor direction, and position (volume is a calculated value). Saline Pump Control The saline pump is driven under the control of the computers through the pump motor and the motor driver. The computer supplies a drive signal to the motor to operate the pump for saline flush and KVO operations. The Control Panel The control panel consists of the touchscreen, a standby button, audible indicators, and an armed light. It also has connectors for connection to the injector head and the hand controller. The control panel can be mounted on the injector head or on a patient table (bed) rail mount. The control panel has a swivel base, allowing it to be easily rotated to a position for optimal viewing. Standby Button When you press the Standby button it immediately disables the operation of the ACIST injection system. To re-enable the system you press the Standby button again, then press OK on the screen. When the Standby button is engaged the system will not inject contrast.
This is indicated by the NO INJECTION icon on the face of the button. Armed Light A green light illuminates when the system is ready to perform an injection. Section 1 System Overview 7 ACIST System Overview Injection Motor Control Injector Head Electronics The computer system consists of two microprocessors. Major functions such as the injection motor movement and saline pump motor movement are monitored by both microprocessors. Page 22 Control Panel Cable Connection This connector is used to connect the injector head to the control panel. Injector Head Electronics ACIST System Overview Hand Controller Connection These connectors are used to connect the hand controller to the control panel. Touchscreen Display The touchscreen serves as the user interface, providing operator prompts, status information, and alerts. The touchscreen also allows you to enter commands and to make various parameter selections. It does this by delivering an amount of contrast that is proportional to the amount of force exerted on the Contrast button. The hand controller eliminates the distractions that can occur with more traditional methods and it frees you to monitor the patient. The hand controller also allows you to step away from the table during the injection, thus reducing possible exposure to radiation. The hand controller contains two buttons. The top button allows control of the contrast media and the bottom button allows control of saline. 8 Section 1 System Overview ACIST Medical Systems, Inc. Note: Specific cables may be needed, depending on the imaging system. For more information, contact an ACIST representative. Section 1 System Overview 9 ACIST System Overview 1. Description of Accessory Items The patient kits are custom designed and manufactured. Each is provided sterile and pre-assembled, minimizing the possibility of interconnection in the wrong manner while ensuring positive connections.
All patient kits are for single-use only, except for the multi-procedural use syringe assembly designed for the CMS2000, Voyager and ACIST CVi. ACIST Pressure Transducer Cartridge Disposable pressure transducer cartridge Some manifold kits contain a disposable “snap in” pressure transducer cartridge that can be used with pressure monitor to record pressure waveforms. The pressure transducer cartridge provides a sealed membrane barrier between the fluid path and the Acist pressure transducer backplate, allowing the transmission of pressure waveforms while maintaining a sterile barrier. The ACIST injection system can be ordered with a pressure transducer backplate sensor that is used to hold the disposable pressure transducer cartridge. Pressure Monitoring Interconnect Cable A pressure monitoring interconnect cable provides the signal connection from the ACIST-supplied pressure transducer backplate to the monitor or trace equipment. The interconnect backplate cable part number depends on the make and model of the hemodynamic monitoring equipment used. Contact ACIST Medical Systems to obtain the pressure monitoring interconnect cable. Section 1 System Overview 11 ACIST System Overview For more information, see the Instructions for Use document packaged with each box of patient kits. Description of Accessory Items The patient kits are custom designed and manufactured. Each kit is delivered sterile and pre-assembled, minimizing the possibility of interconnection in the wrong manner while ensuring positive connections. All patient kits are for single-use only, with the exception of the multi-use syringe assemblies used with Models CMS2000, Voyager and ACIST CVi. Sign in Forgot Password. My Bench Close Sign In Not A Member. Sign Up Join MedWrench OK name type Receive Summary Emails. EmpowerCTA dual-syringe, fixed-rate contrast injector incorporates advanced technology and patient safety features.
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