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ACIST Contrast Delivery System 
User Manual

900468-001, 02     2010-01

and CMS2000 and E2000Voyager

™

Summary of Contents for ACIST CVi CMS2000

Page 1: ...ACIST Contrast Delivery System User Manual 900468 001 02 2010 01 and CMS2000 and E2000Voyager...

Page 2: ...This page intentionally left blank...

Page 3: ...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 SYST...

Page 4: ...ia 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...

Page 5: ...nt 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...

Page 6: ...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...

Page 7: ...atient kits 1 877 BRACCO 9 00800 2247 8387 31 43 328 1318 Contact your local ACIST distributor FAX Number 1 866 272 1619 31 43 328 1329 Contact your local ACIST distributor Ordering systems and access...

Page 8: ...n 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 c...

Page 9: ...diate and direct supervision of a physician who is specifically trained in angiogra phy and in the operation of this unit System operation must be monitored at all times and specific operational and m...

Page 10: ...ure 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 o...

Page 11: ...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 mu...

Page 12: ...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...

Page 13: ...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...

Page 14: ...Information Warnings xii ACIST Medical Systems Inc P N 900468 001 Rev 02...

Page 15: ...ers 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 enable...

Page 16: ...uchscreen Display 10 Syringe Valve Sensor 3 Standby button 12 Universal or CVi Contrast Hanger 11 Contrast Sensor 13 Air Column Detect Sensor 15 Manifold clip and sensor 8 Power Supply 9 Syringe mount...

Page 17: ...vides 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 prese...

Page 18: ...ringe 24 Hand Controller Connection 17 Contrast Container 23 Saline Bag 21 Disposable Pressure Transducer Cartridge System Components Disposables 22 Saline Tubing 19 Automated Manifold 26 Stopcock ACI...

Page 19: ...ne 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 cont...

Page 20: ...inject contrast into the patient s vasculature This model does synchroize with certain X ray systems For specific models and series refer to Section 9 Note Syrchronization is only possible provided th...

Page 21: ...A D converter as speed monitor and position monitor signals These allow the computers to check motor speed motor direction and position volume is a calculated value Saline Pump Control The saline pum...

Page 22: ...ake various parameter selections The AngioTouch Hand Controller The AngioTouch Hand Controller lets you precisely control the volume and rate of contrast that is delivered to the patient It does this...

Page 23: ...n system is to be used with contrast media that has a viscosity between 26 6 and 4 6 centipoise It also must be used with angiography catheters that are appropriately rated for pressure and flow rate...

Page 24: ...e addition of an adaptor cable for cable from PS to X ray to be used with older x rays systems Description of Accessory Items The following accessory items are used with the ACIST injection system and...

Page 25: ...five procedures An Automated Manifold Kit with or without a disposable pressure transducer cartridge containing an automated manifold saline tubing saline spike and other components An AngioTouch Hand...

Page 26: ...allows the injector head with or without a control panel to be mounted on a table bed rail The control panel mounting bracket allows only the control panel to be mounted on a patient table bed rail T...

Page 27: ...and control panel can be mounted in a variety of configurations On a movable cart On a patient table bed rail To give the operator control of all aspects of contrast delivery and to allow the lab staf...

Page 28: ...the U Joint is correctly positioned and tighten the lock knob to secure it to the patient table bed mount See photo at left Option 2 If the patient table bed is unable to be raised or lowered to matc...

Page 29: ...le bed is unable to be raised or lowered to match the height of the U Joint of the pedestal cart Transfer requires two persons 1 Maneuver the cart in an accessible position for transfer See photo at l...

Page 30: ...D shaped washer 7 Slide the other concave washer onto the bolt with the concave end away from the D shaped washer If installed correctly there should be a slight gap between the concave washers near...

Page 31: ...the bracket aligning the embossed molded areas 3 Remove the liner from the tape on the bracket 4 Attach the bracket to the bottom of the injector head Position it to the left side of the V formed by t...

Page 32: ...lug located on the power entry module identifies the power supply selection 100 120 VAC or 200 240 VAC Be sure the voltage selection plug is in the correct position before plugging the system into a w...

Page 33: ...T injection system This cable may only be substituted with an equivalent medical grade power cable Note On systems interfacing to Philips x ray systems the power cord is part of the imaging system int...

Page 34: ...ply Put lock ring on DC Cable before conecting The cable with circular connectors and sockets connects from the power supply center right to the lower left corner of the injector head Power Supply Con...

Page 35: ...ead The cable with the rectangular connectors connects from the bottom of the injector head to the bottom of the control panel Note Securely tighten the cable screws to the control panel 4 3 4 Connect...

Page 36: ...This page intentionally left blank Installation 22 Section 2 Installation ACIST Medical Systems Inc P N 900468 001 Rev 02...

Page 37: ...ower on The system will take about one minute to boot up When the power is on the power indicator green light located next to the power switch is also on WARNING In the case of power blackouts power b...

Page 38: ...until the system completes the calibration process The Cardiac Peripheral selection screen is displayed 6 Select the type of procedure you wish to perform Your selection dictates the set of pre define...

Page 39: ...fold kit components from their sterile pouches and remove all caps Load syringe assembly screen Tighten contrast spike on syringe assembly Open the chamber by pulling the white button Insert the syrin...

Page 40: ...Clip manifold assembly into the manifold valve sensor 11 Connect the automated manifold to the syringe assembly 12 Clip the manifold assembly into the manifold valve sensor by rotating the manifold d...

Page 41: ...ucer sensor backplate Vent cap Contrast sensor and spike clamp Make sure contrast sensor is securely placed around the spike tubing Syringe filling screen Load saline screen If using a transducer cart...

Page 42: ...to the left side 21 Place the tubing in the saline pump leaving some slack on either side of the pump 22 Position the black v teeth guides all the way to the bottom and then move them up to the next h...

Page 43: ...sed You can use the small mallet provided on the back of the pump to tap the tubing 30 Press DONE Inspect the tubing and make sure it contains no air bubbles Flush saline tubing screen Tap the tubing...

Page 44: ...n detect sensor is not a substitute for user vigilance AngioTouch Hand Controller setup screen High pressure injection tubing placed in air column detect sensor 35 The scrub person should hand off the...

Page 45: ...Calibrate HC button This is the second button from the left on the bottom row of the control panel screen Contrast button Calibration failed screen Calibrate HC button After hand controller calibrati...

Page 46: ...System Setup 32 Section 3 System Setup ACIST Medical Systems Inc P N 900468 001 Rev 02 This page intentionally left blank...

Page 47: ...messages and provides feedback on the state of system operations Contrast Usage Feedback Display 3 Contrast Remaining Displays the amount of contrast remaining in the syringe 4 Contrast Delivered Dis...

Page 48: ...t flush with saline purge tubing with contrast or keep a vessel open 10 X ray and KVO Parameters Enable you to set the x ray interface or KVO parameters available only with the Voyager and CVi periphe...

Page 49: ...selected for that injection during the current case or since start up Injection Parameters You can set the following four parameters FLOW Displays the greatest flow rate ml sec obtainable if the hand...

Page 50: ...syringe through the contrast valve and into the contrast container Purging the high pressure injection tubing requires turning the 3 way stopcock off to the patient KVO Keep Vein Open or Keep Vessel O...

Page 51: ...ual to the amount specified on the FLOW parameter Also the display area will change to an amber colored background In VARIABLE RATE mode pressing the Contrast button will cause an injection proportion...

Page 52: ...Column Detector Senses air in the proximal end of the high pressure injection tubing If air is detected in the tubing all fluid delivery functions are disabled WARNING Do not depend solely on this sen...

Page 53: ...ating click Warning is displayed Beep Touchscreen Messages Touchscreen key is pressed Click X Ray Interface Parameters The following x ray parameters are available on the Voyager and CVi peripheral mo...

Page 54: ...ing system There are several conditions that must be met before this signal is active 1 The injector must be armed 2 The injector start must be active 3 The X ray delay has passed Hand Controller Pres...

Page 55: ...injection parameters and limits defined on the touchscreen The injection can be stopped at any point in the procedure by simply releasing the button Important There is a quick response time between pr...

Page 56: ...t s weight in kg and then press Enter The settings for the parameters flow volume pressure and rise time will be calculated automatically by the system 6 Select injection type by pressing the desired...

Page 57: ...then closing the stopcock to patient opening to a syringe or waste container and flushing the injection line high pressure with saline Press the Saline button on the hand controller to flush the entir...

Page 58: ...to return to the previous value 3 Press the INJECT MODE button in the lower left corner of the screen to select either a VARIABLE or FIXED RATE injection Repeatedly press the button to toggle between...

Page 59: ...e syringe to make sure there is always contrast available for the next injection When the system detects that there is an insufficient amount of contrast the refill function begins automatically The a...

Page 60: ...d release the Saline button on the hand controller The tubing will be flushed with saline for 10 seconds To stop flushing before the 10 second timeout press the Saline button again or press CANCEL If...

Page 61: ...nge is 0 1 10 ml min There is a 20 minute timeout on the KVO function providing for a maximum of 200 ml of saline to be dispensed during any single activation 2 Select KVO in the SELECT MODE box 3 Thi...

Page 62: ...engaged remove the syringe by rotating the chamber to the open position 7 Disconnect and discard the patient kit hand controller high pressure injection tubing high pressure 3 way stopcock contrast sy...

Page 63: ...mber of cases per syringe If you exceed the recommended number of cases the performance of the patient kit may be degraded The following prompt is displayed Use new syringe 5 Press NO 6 Close the whit...

Page 64: ...setup for the next case System Shutdown To shut down the system 1 Record all case information for example CONTRAST DELIVERED LAST INJECTION etc before ending a case This information is cleared after t...

Page 65: ...it for cracks crazing or other deterioration Use of a damaged chamber sleeve may result in its rupture during injection If any irregularities are observed do not use the ACIST injection system Call AC...

Page 66: ...t will not catch on the removable cover Carefully pull the backlight cover away from the outside edge of the backlight pulling all the way around the perimeter of the cover Lift the cover off the syri...

Page 67: ...applying a small amount of mineral oil If a good pressure waveform cannot be achieved one possible cause may be a worn or damaged rubber membrane Important Do not soak the rubber membrane or expose it...

Page 68: ...heels on the cart used to transport the system in the lab Check for wheel damage and make sure the wheels are securely fastened to the cart For replacement parts call ACIST Technical Services Annual P...

Page 69: ...k for damaged or loose connections 4 Check the integrity of the wall power outlet 5 Perform system cleaning For failures or problems that cannot be resolved contact an ACIST Medical Systems representa...

Page 70: ...pressure injection tubing that is exiting the manifold 4 Slowly aspirate pull fluid from the saline container to the hand syringe making sure all air is removed from the lines transducer cartridge an...

Page 71: ...e attached properly You may need to tighten them or disconnect them and then connect them again 2 Check for kinks in the tubing 3 If the hand controller still will not calibrate replace it Functional...

Page 72: ...sing small black buttons on the side of the pump and moving them up or down For saline pump malfunction OT raise the top part of the pump begin to flush and lower the top portion of the pump again dur...

Page 73: ...ir is detected in the high pressure injection tubing by the air column detector The high pressure injection tubing has been pulled and the air column detect has been triggered To clear air from the tu...

Page 74: ...ation Remove the syringe assembly from the chamber or check the Syringe Valve Sensor Communication Error Has Occurred Communication Timeout Communications errors 1 Shut down the system and power up ag...

Page 75: ...by shutting down the system and powering up again Front Stop Reached Forward Limit Reached The syringe actuator ram has reached the maximum forward position The system will not allow any forward move...

Page 76: ...er at any time during a case you must calibrate it Injection Motor Malfunction OS Injection Motor Malfunction OT 1 Internal error 2 For OT errors there may be a restriction in the fl uid fl ow 1 Make...

Page 77: ...l a service representative to report it You can try to continue by turning system power off and on again Manifold Valve Closed The manifold valve was detected as closed when it should have been open D...

Page 78: ...pressure from the Ram 3 The patient kit is defective 4 Special Case Manifold Valve and Syringe Valve are Open at same time 1 Check the manifold and make certain that it has been secured into the hold...

Page 79: ...se messages The notations 1 and 2 are useful to report to a service representative if a call for service is needed Stopcock is not open to allow injection Catheter is kinked Preset pressure is too low...

Page 80: ...ing system before the next injection Saline Pump Malfunction OS Internal error 1 Press OK to continue 2 Write down the screen message and call a service representative to report the message Saline Pum...

Page 81: ...not detected or the small metallic ball in the top of the syringe is stuck in the up position This error message will occur if you try to go past the fi rst step in the setup process without insertin...

Page 82: ...h function after this time The timeout serves as a safety feature The function can be repeated There is a 10 second limit for Purge The internal timeout for the purge function is 10 seconds The system...

Page 83: ...ces comply to ISO 60601 1 and UL 2601 1 Load Rate Fill 1 2 ml sec syringe air purge 6 ml s Safety and Sensor Checks Safety and Sensor checks Limit Switches Fixed Position forward and reverse limit swi...

Page 84: ...si 1 kPa increments 4 In 0 1 sec increments Saline Rate Automated fixed flow rate of 100 ml min Status Readouts Contrast Remaining Real time total volume in Injection Syringe Contrast Delivered Real t...

Page 85: ...or with oxygen or nitrous oxide Transportation and Storage Requirements Type of Temperature Range Injection System Patient Kits Ambient temperature range 40 to 122 F 40 to 50 C 0 to 122 F 18 to 50 C...

Page 86: ...star Angiostar Polystar GE Advantx Series p Innova Series p Philips Allura Xper FD10 p Allura Xper FD20 p Integris Allura Series p Toshiba Infinix i series p p pending This table reflects current inte...

Page 87: ...ED WITH RESPECT TO THE ACIST SYSTEM INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTIBILITY AND FITNESS FOR A PARTICULAR USE OR PURPOSE ACIST MEDICAL SYSTEMS SHALL NOT BE LIABLE FOR ANY...

Page 88: ...dical Systems within thirty 30 days of the apparent malfunction EXCEPT AS EXPRESSLY PROVIDED HEREIN ACIST MEDICAL SYSTEMS MAKES NO WARRANTY OF ANY KIND EXPRESS OR IMPLIED WITH RESPECT TO THE VOYAGER S...

Page 89: ...DESCRIBED ABOVE The representations and warranties contained in this manual may be changed modified or amended only by an agreement signed by an authorized representative of ACIST Medical Systems War...

Page 90: ...g current Protective earth ground Attention Consult accompanying documents On Off Type CF Equipment Use only with other parts marked with this symbol O Symbols 76 Section 11 Symbols ACIST Medical Syst...

Page 91: ...P N 900468 001 Rev 02 ACIST Medical Systems Inc Notes 77 Notes...

Page 92: ...ACIST Medical Systems Inc 7905 Fuller Road Eden Prairie MN 55344 USA Authorized European Representative Medical Product Service GmbH Borngasse 20 35619 Braunfels Germany...

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