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Arrow®

AC3 Optimus

Intra-Aortic Balloon Pump

IABP Performance Evolved

Safety Information

Indications for Use: 

The AC3™ IABP Series IABP (Intra Aortic Balloon Pump) system is clinically indicated for the following conditions; 1) Acute Coronary Syndrome, 2) Cardiac and Non-Cardiac Surgery, 3) Complications of Heart Failure Contraindications: Intra-Aortic Balloon Pumping (IABP) requires an adequate location in which to place the balloon and a functional aortic valve. Further, the clinician must have confidence that the patient will benefit from the procedure. The conditions described below are contraindications. Absolute
  • Hemodynamically Significant or Severe Aortic Valve Insufficiency – If an aortic valve is incompetent, inflation of an IAB will result in increased regurgitation into the left ventricle. The flow of blood back into the left ventricle will reduce forward CO, further aggravating the patient’s abnormal hemodynamics.
  • Aortic Aneurysm or Aortic Wall Disease (Including Dissection) – Movement of an IAB may jeopardize the integrity of the aortic wall in a patient with either of these conditions. Use of the IAB in patients with aortic dissection or suspected dissection should be avoided until the integrity of the aortic wall is established as rupture of the aortic wall may result from IAB use.
Relative
  • Atherosclerosis or Severe Peripheral Vascular Disease (PVD) – In some patients with severe atherosclerosis, the femoral arteries may be sufficiently plaque-filled and tortuous to prevent placement of the balloon. The presence of significant PVD is a predictor of IAB related
  • End-stage Disease or Sepsis – Use of IABP may not be justified in some patients with late-stage terminal illness. This is an aggressive and invasive procedure and should be used only if the patient will derive significant clinical benefit. Sepsis is contraindicated due to the risk of catheter or insertion site
  • Severe Coagulopathy – Use of the IABP may not be justified in patients with severe clotting disorders as the IABP has been shown to increase the risk of bleeding complications.
Warnings: 1) Power the IABP OFF prior to disconnecting or reconnecting the control module. Failure to do so may result in damage to the control module or IABP. 2) Do not transport the AC3™ Series in an aircraft with the control module in the upright position. You must position the control module down, flat to the pump module prior to transport, or you can remove the control module from the pump and carry it. 3) You cannot start pumping if the HE tank is OFF or empty. 4) The pump should NOT be used for patient transport as there is inadequate battery time available. Plug the IABP into AC power to charge the battery. 5) The pump should NOT be used for patient transport as battery support may not be available. Be sure to connect the IABP to AC power. 6) Certain monitors may process pacing signals and reinsert spikes that do not meet the AC3™ Series criteria. In this case, you must use the patient ECG cable to detect pacers and trigger correctly. 7) Zero the FiberOptix® sensor PRIOR to IAB insertion. The FiberOptix® sensor cannot be zeroed after IAB insertion. Failure to properly Zero the FiberOptix® sensor may affect the accuracy of the AP FiberOptix® 8) Do not re-zero the FiberOptix® sensor during use. This may affect the accuracy of the AP FiberOptix® values. 9) Automatic timing in AutoPilot® mode may not be appropriate in all patients. The clinician should monitor the AP waveform to determine the accuracy of timing. If timing is not appropriate in AutoPilot® mode, select 10) Operator mode and set timing manually. 11) Internal trigger should not be used when the patient has intrinsic cardiac activity. This can cause incorrect timing which may impair the patient hemodynamics. 12) Ensure alarm volume is set high enough to be heard in your environment. The Corner switch illuminates when an alarm is issued, so if the alarm cannot be heard due to a High Noise environment, ensure the IABP and patient are continually monitored by trained personnel. 13) Do not use Pacer triggering during operation of Electro-Cautery Devices. 14) Check the grounding pad and all connections to ensure that the grounding system is working properly. Ensure that the Electrocautery grounding pad is properly connected to the patient and Electrocautery device. The skin should be cleaned thoroughly and conductive gel applied. Failure to do so may result in severe injury to the patient.  Follow all instructions for use, warnings and precautions associated with the Electrocautery Device being used in your facility. 15) Position the ground pad as far away from the IABP ECG leads as possible to reduce the risk of interference on the ECG signal. Failure to do so may result in improper triggering. 16) “Warning – The IABP System is MRI Unsafe: 17) The use of MRI in IABP patients is NOT recommended because the Intra- aortic Balloon Pump (IABP) is MRI unsafe and should never be used during an MRI procedure. In addition, use during an MRI would require IABP therapy be discontinued during the MRI procedure, which may increase the risk of hemodynamic instability or thrombus on the IAB components, such as the membrane, catheter or sheath. Even patients, who are anticoagulated, may have an increased risk of thrombus due to the IAB remaining dormant during the MRI procedure. 18) Pump shutdown requires immediate staff action. Note the time and call knowledgeable maintenance personnel. 19) If pumping cannot be restored within 15-30 minutes, manually inflate and deflate the IAB several times per hour to reduce the risk of thrombus formation. Consider removing the balloon. Arrow International recommends that you have a back-up IABP system available. 20) The AC3™ Series IABP System requires a trained operator who has read and understands all sections of this manual prior to using the AC3™ Series IABP System. Only medical personnel trained in the use of IABP devices and acting under a physician’s orders should operate this system. 21) DO NOT touch the IABP System during defibrillation. The possibility of electric shock exists. 22) Be prepared to maintain IABP operation in critical situations by having a backup IABP system and extra helium bottles ready in case of system failure or helium depletion. 23) Be prepared to change operations mode if the currently selected operation mode does not provide adequate assist. 24) Do not use solvents (e.g., acetone or other degreasing agents) to prepare the skin. They may damage the IAB catheter or other plastic components of the system. 25) This device is frequently used in acute stages of cardiac failure. The clinician must be prepared to change operations and/or trigger modes to optimize signal recognition, and utilize pharmacological, respiratory, temporary pacing, and other support measures to help stabilize the patient. 26) If balloon pumping is interrupted and cannot be continued within 15-30 minutes, connect a 50/60cc syringe to the balloon connector and inflate and deflate the balloon manually. Thrombus formation may result from blood becoming trapped in the folds of a dormant balloon. 27) The Internal Trigger mode should be used only if the patient has no myocardial activity and/or ventricular ejection. You must select Operator mode, press the INTERNAL control key under the TRIGGER key and Press CONFIRM if you wish to operate the AC3™ Series IABP in Internal trigger mode. 28) Arterial Pressure triggering is not recommended if the patient is in atrial fibrillation or has tachyarrhythmias. These conditions produce irregular Arterial Pressure waveforms. 29) With acutely ill patients, both the ECG and Arterial Pressure waveforms may be inadequate for triggering. 30) Certain monitors may process pacing signals and reinsert spikes that do not meet AC3™ Series criteria. In this case, the patient ECG cable must be used to use pacer triggers. 31) Use of AFIB trigger mode may produce late deflation, which could compromise cardiac output. When using AFIB trigger, or when setting deflation beyond 100%, be sure to carefully monitor hemodynamics. Be prepared to select an alternate trigger mode, or select NEVER R-Wave if deflation is too late and patient hemodynamics are compromised. 32) If the balloon pressure waveform does not resemble a normal or acceptable waveform, take immediate action to correct a potentially unsafe condition. See the Troubleshooting section for further information. 33) If an IAB is suspected of being occlusive, do not reduce the IAB volume to less than 2/3 (66%) of the balloon’s capacity. To prevent thrombus formation, pump the balloon at its maximum capacity for five minutes every one to two hours. A smaller IAB volume should be considered. 34) A properly coded balloon connector should be used with all balloons, including those not manufactured by Arrow International. Using a balloon connector coded for a volume greater than that of the balloon can have serious clinical consequences and is not recommended. Verify balloon volume prior to operating the pump. 35) Real time timing or R-Wave deflation may result in hemodynamically late deflation. Patients should be closely monitored when using this timing method. 36) Use permanent alarms OFF with extreme caution. Monitor the AC3™ Series at all times when in this mode. Reinitiate alarms as soon as possible to reduce the risk of negative sequelae to the patient. 37) Do not ignore alarm messages. Do not turn off alarms except for brief periods while correcting an alarm condition. After correcting an alarm condition, use the ON control key in the ALARMS section of the keypad to re-enable the alarms. 38) The AC3™ Series should be connected to AC power whenever possible, even when not in use. This will maintain the battery charge and ensure the pump is ready for use when needed. The AC power indicator light should be ON when AC power is connected. 39) A fully charged battery will power the AC3™ Series for a minimum of 90 minutes. To fully recharge a completely discharged battery, the system must be connected to AC power for approximately eight hours. Eighty percent of the battery’s charge will be restored within four hours. 40) Do not continue to move the inflation point to the left, even to increase AUG further. Early inflation can compromise systole. 41) The operator must closely observe the effects of inflation and deflation timing when settings are altered. Failure to do so may adversely impact the expected benefits of counterpulsation and have serious clinical sequelae. 42) The operator must continuously monitor the patient’s Arterial pressure waveform whenever the deflation point is set beyond 100%. 43) Do not attempt to adjust timing based on ECG or Pacer waveforms. Inflation and deflation points should be set based on the Arterial pressure waveform. Monitor this waveform to achieve optimum hemodynamic benefit. 44) Arterial pressure triggering is not recommended if the patient is in atrial fibrillation or has tachyarrhythmias. These conditions produce irregular arterial pressure waveforms. 45) When transporting IABP dependent patients, anticipate the need for alternate power sources. Breakdown of vehicles, elevators, etc. may cause unexpected delays in reaching your destination AC power source. 46) Do not attempt to transport if the “”BATTERY CHARGED”” LED is not illuminated while connected to AC power. Sufficient battery power may not be available. 47) The AC3™ Series should not be used in conjunction with an AC power generator. 48) When transporting an IABP patient, move the patient and the AC3™ simultaneously to prevent stress on the balloon catheter and connector. 49) Do not turn off alarms except for brief period while correcting an alarm condition. After the alarm condition has been corrected, enable the alarms by pressing the alarms-on control key. 50) It is highly recommended that alarms are only turned OFF (Disabled) when the pump is under constant observation by a trained clinician. Pay attention to alarm messages as further action may be required to maintain safe and effective IABP support. 51) Do not modify this equipment without authorization from the Manufacturer. 52) Use only accessories supplied with the AC3™ Series pumps, or accessories that meet specifications provided by Arrow International. Use of other accessories may result in incorrect system operation and/or inadequate defibrillation protection. 53) Do not use oxygen or any drive gas other than USP helium. 54) The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. 55) Tip Hazard if the device is pushed from the top of the unit, especially when the Display is in the highest position. 56) RISK OF FIRE, REPLACE FUSE AS MARKED label is located on the lower left corner of the I/O Panel. Please refer to the Operator manual for replacement fuses information. 57) This product can expose you to chemicals, including lead, which are known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov. Cautions: 1) Only fiber optic sensors provided with Arrow International IAB catheters should be used with the AC3 Optimus™. Use of other fiber optic sensors may cause damage to the IABP system or produce inaccurate AP readings. 2) Use ONLY the CAL key which is supplied with the FOS IAB. Failure to use the correct CAL data may result in inaccurate AP readings or No AP signal. 3) The FiberOptix® sensor will not work properly without the calibration key. The calibration key must be connected to properly zero the sensor and provide the correct calibration information to the pump. The calibration key must not be changed during use of the sensor. Using a calibration key other than the one supplied with the IAB may result in incorrect AP readings. 4) Leave the CAL key connected at all times. If you remove the CAL key and reinsert the same CAL key, the system will retain calibration and zero values. However, if another CAL key is inserted, you will lose all previous CAL and Zero values, and the accuracy of the AP FiberOptix® sensor readings may be affected. 5) Pacer output must be available from the bedside monitor for pacers to be detected and displayed by the AC3™ IABP. Check the AC3™ Series set up of the bedside monitor to insure pacer output is turned ON, when pacer detection is required. 6) Only connectors which have ARROW stamped on the connector will be properly recognized. All 30, 35, 40 and 50 cc connectors with Arrow, Kontron or AVCO will be properly recognized. DO NOT USE connectors other than the 30, 35, 40 and 50 cc connectors with KONTRON, AVCO or ARROW markings, these may NOT be properly recognized and may result in an incorrect balloon volume setting. 7) Do not use a 3 lead ECG cable or phone to Nicolay slave cables. The 3 lead ECG cable and phone to Nicolay cables will not work properly with the AC3™ Series. 8) Zero FOS prior to IAB insertion. Zeroing of the FOS sensor can only be done prior to insertion of the IAB (outside of the patient). Once an AP waveform from the FOS sensor is detected, zeroing cannot be performed. 9) Verify that the AP MAP value that is used to calibrate the AP FOS MAP is zeroed and leveled appropriately. The AP source should be verified for accuracy as well. 10) Follow the manufacturer’s instructions to connect the heparinized fluid source to the constant flush system. All pressure tubing, stopcocks and connections must be filled completely with fluid and be free from air bubbles before proceeding with zeroing or calibration. 11) The alarm limit should be set low enough to reduce the risk of intermittent alarms due to minor changes in the patient condition, but not so low that serious deterioration of the hemodynamic status or a disconnection in the AP system is not detected. 12) If the AP alarm is being used primarily to monitor for AP disconnect, the MAP should be used, as the alarm is available when the pump is pumping and when the pump is not pumping. The AUG alarm is only available when the pump is pumping. This may not alert the user to disconnection under all conditions. 13) Switching the AP SOURCE during an AP alarm could reset the alarm even if a serious condition, such as a tubing disconnection has occurred. Even if the alarm has been reset, the user should verify that the AP source (transducer or monitor) lines are intact and that bleeding from the source of the AP alarm has not occurred. 14) The OFF button under PUMP STATUS indicates a condition where the pump has stopped and the patient is not receiving IABP support. PUMP OFF should be used only under direct clinical supervision. The pump should be re-started as soon as possible to prevent thrombus formation on the surface of the IAB. A timer will be displayed indicating the time that the pump has been OFF (Not pumping). 15) When Pacer pulses are present or may be expected, use the 5-lead ECG cable and ECG SKIN source, to ensure that Pacer pulses are properly detected. Incorrect Pacer detection can result in mis-triggering and timing which may reduce IABP effectiveness. 16) When Pacer trigger is selected, monitor timing carefully to ensure that the patient is being properly assisted. Be prepared to change trigger modes or Operational modes if the Pacer therapy is discontinued or the Pace pulse is not detected by the IABP. 17) R-Wave deflation may not be appropriate for all patient conditions. If you select ALWAYS R-Wave, closely monitor patient hemodynamics and be prepared to select NEVER R-Wave deflation in the event that hemodynamics are worsening. 18) If IABP volume is changed while pumping patient support will be momentarily suspended as the volume is updated. Insure the patient will tolerate this procedure before pressing APPLY to initiate the volume change. 19) Touch Screen Calibration should NOT be performed while the device is on a patient. 20) If you select ALWAYS R-Wave for the Deflation Timing Method, monitor the patient closely to ensure that deflation timing is acceptable. Late deflation can result from selection of this setting. 21) 1.  Do not use electrodes after expiration date. Ensure proper electrode contact. 2.  If using Translucent electrodes check the expiration date. Expired electrodes may cause excessive artifact or poor ECG signal. 3.  Do not use a 3-lead ECG cable or phone to Nicolay slave cables. The 3 lead ECG cable and phone to Nicolay cables will not work properly with the AC3™ Series. 22) Bedside monitors have different signal output characteristics. DO NOT use any monitor with a delay of greater than 20 milliseconds between the actual patient signal and the monitor output, since It may cause incorrect timing. If you use or reject a pacer spike for triggering, ensure that the bedside monitor outputs the pacer spike. Many monitors have pacer detection and output disabled in the default configuration. Consult the manufacturer for specific information regarding the bedside monitor. When in doubt, use the direct signal connections from the patient to the AC3™ Series for optimal performance” 23) The FiberOptix® sensor must be zeroed prior to placing the IAB in the patient. Failure to zero the transducer may result in inaccurate AP values. The non-zeroed FiberOptix® sensor signal will be adequate for WAVE® timing in the AC3 Optimus™ but should not be used for hemodynamic assessment of the patient. 24) When the FOS is NOT ZEROED, the hemodynamic numeric information may not be accurate. Use an alternate AP source for treatment decisions. 25) Use of Pacer triggering in patients with less than 100% paced rhythms will reduce the effectiveness of IABP support. Ensure that the appropriate trigger mode is selected to optimize cardiac support. 26) When using the AC3 Optimus™ IABP with a FiberOptix® Fiber Optic AP Sensor, assess timing from the IABP AP FiberOptix waveform. AP waveforms from fluid filled transducers have significant delays which will make timing appear earlier than the FiberOptix waveform. 27) Choose the appropriate Pacer trigger mode for the type of pacer being used. Do not use V-Pace trigger for A-Pacing and do not use A-Pace trigger for V or AV sequential pacing as improper timing may result. 28) At altitudes above 10,000 ft., the AP FiberOptix® signal accuracy may be affected. If you must use the pump above 10,000 ft., and you lose signal or accuracy, have a second AP source available and be prepared to switch to that source. 29) Transport may involve high noise environments. In some environments, audible alarms may not be audible by the operator. Therefore, it is highly recommended that the operator have clear visibility of the LCD in transport situations, since the AC3™ Series also displays alarms on the LCD when they occur. 30) Consult your local policies and procedures for the maximum weight that should be lifted by one person. The IABP weight with all accessories is just over 100 lbs; so, use the appropriate number of personnel to lift based on your local safety regulations. In general, two people should be used to lift the IABP to avoid injury to users and damage to the IABP. 31) Do not reduce the volume delivered to the balloon to less than 2/3 (66%) the capacity of the balloon to decrease the risk of thrombus formation. For example, a 40cc IAB should not have volume reduced to less than 26.5cc. Also, when weaning by volume, We recommend that the pump be returned to full volume for five minutes every one to two hours. An option to consider would be to return the IAB to full volume and follow the recommendations for weaning by decreasing frequency. 32) Caution ESIS is operational at all times; however, Arrow International recommends that you use a five-lead ECG cable for maximum effectiveness. 33) Ensure that the IAB volume connector is the same size (color) as the one that is being replaced to ensure the IAB volume is the same. 34) Do not remove panel covers. Panel covers should be removed only by Arrow personnel. 35) Touch Screen Calibration should NOT be performed while the device is on a patient. 36) Do not clean the AC3™ Series while it is connected to a patient. 37) Examine all cable’s outer casing carefully for perforations or damage before cleaning. Do not soak a perforated cable. Have it replaced immediately. 38) Clean and disinfect using only the cleaning agents listed. Do not use other solvents. Avoid acetone, 100% phenol cleaners, ether or higher concentrations of formaldehyde. 39) Do not submerge electrical connectors during disinfection. Secure a 0.3mm-thick polyethylene wrapping over the connector before cleaning. Visually inspect all cables and accessories including the ECG, AP transducer/cable and power cord. If visible defects are present, replace the cable or accessory. If a visible defect is present in the power cord, DO NOT USE IN AC MODE. Replace the power cord. Operate in Battery mode ONLY until the power cord is replaced. Wear appropriate protective gear (mask, eye-shield, gloves and protective clothing as needed when handling accessories that have biological contamination. 40) When the HE supply icon is RED, ensure that you have another HE tank available. The AC3™ Series cannot pump without an adequate HE supply. Do NOT transport the pump when the HE supply is low. Change the HE tank first. 41) High pressure gas canisters should be handled by trained personnel only. 42) Use only the fuse type and rating specified. Call the Arrow International service number for assistance. 43) Only Arrow International Field Service Engineers or their authorized representatives should remove panel covers. Removing the protective covers will expose you to a shock hazard. 44) As batteries age, run time may be shorter than expected. Be sure to perform a battery load test to confirm run time, and pay close attention to the 20, 10 and 5 minute alarms. In rare cases, either only a subset of these alarms may issue when batteries are nearing their end of life, or the alarms may issue at shorter intervals than the alarm indicates. 45) Do not turn dip switch 6 to the OFF position if you want to use the fiber optic AP function. 46) Grounding reliability can only be achieved when equipment is connected to an equivalent receptacle marked “Hospital Grade”. Adverse events: As with any invasive procedure, there are risks associated with IABP use. The clinician should weight the Benefits relative to the Risks for each patient. Potential complications may arise from the use of IAB or IABP and include the following: IABP Related Risks – 1) Cardiac Arrhythmias, 2) Ineffective Cardiac Assist; IAB related Risks – 1) Limb ischemia resulting in: Damage to affected leg / Amputation / Loss of function, 2) Aortic Rupture, 3) Aortic Dissection, 4) Emboli from dislodgement of plaque or other tissue, 5) Thrombosis, 6) Embolus formation, 7) Thrombocytopenia, 8) Hemolysis, 9) Sepsis.