Operating Instructions
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CARDIOSAVE OPERATING INSTRUCTIONS
Copyright All rights reserved. No part of this publication may be duplicated, adapted or translated without prior written permission, except within the framework of the copyright laws. © Copyright 2011 Datascope Corp. ™ Trademark of Datascope Trademark Corp. Manufacturer Datascope Corp. 1300 MacArthur Blvd. Mahwah, NJ 07430, USA Phone: 1 800 777 4222 or 1 201 995 8700 Fax: 1 201 995 8910 http://ca.maquet.com http://www.maquet.com
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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WARNING Do not operate this system before thoroughly reading this manual and the associated warnings and cautions. Only use the Quick Reference - Initial Setup if you are already familiar with this product. If not, please continue with the remainder of this manual.
QUICK REFERENCE - INITIAL SET-UP 1. Press the IABP Power Button to turn the IABP on. 2. Ensure the helium tank is open and verify helium pressure. 3. Establish ECG and pressure connections. 4. If using a Fiber-Optic IAB, ensure that the Fiber-Optic Sensor Connector is attached. Otherwise, zero the transducer: Vent the transducer to atmosphere. Press the Zero Pressure key for 2 seconds. Close the transducer. 5. Confirm that the OPERATION MODE is Auto. 6. Attach the IAB catheter and extender tubing to the Pneumatic Module. 7. To initiate pumping, press the Start key. In response, the IABP will autofill and then begin pumping. If desired, IAB Deflation timing can be fine-tuned using the IAB Deflation controls. 8. Verify the setting of the Aug Alarm: Approximately 3 minutes after initiation of assist, verify that the Aug Alarm setting is approximately 10 mmHg less than the patient’s augmented diastolic pressure. If needed, adjust the Aug Alarm setting by pressing the Aug Alarm key and using the arrow keys to change the value. 9. Initial setup is now complete.
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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Foreword Warnings, Cautions and Notes Warnings Cautions Indications for Use Contraindications Brief Description of Intra-Aortic Balloon Therapy Unpacking Information Operator Profile Operator Position Phone Numbers and How To Get Assistance Symbols and Descriptions
1
FEATURES AND CONTROLS
1.1 1.2 1.2.1 1.2.2 1.2.3 1.2.4 1.2.5 1.2.6 1.2.7 1.2.8 1.3 1.3.1 1.3.2 1.3.3 1.3.4 1.3.5 1.3.6
General System Overview Monitor Display ECG Waveform Trigger Rate Parameter Arterial Pressure Waveform Arterial Pressure Parameter Balloon Pressure Waveform Augmentation Parameter Message Display Area Icon and Indicator Area TouchScreen OPERATION MODE Keys Calibrate Pressure/Zero Pressure Key Standby Key Start Key Trigger Menu Sources and Thresholds Menus Sources Menu Thresholds Menu IAB Frequency Menu Augmentation Menu Timing Menu Lock/Unlock Screen Keys Open/Close Menus Keys Preferences Key Display Preferences Menu Audio Preferences Menu Printer Preferences Menu Pump Options Menu Help Screen Area Reference Line Control Area IAB Fill Key Freeze/Unfreeze Display Key Aug (Augmentation) Alarm Control Area Pause Audio Key Print Strip Key Alternate Power-Up Mode Pump Module Back Panel Top Panel
1.3.7 1.3.8 1.3.9 1.3.10 1.3.11 1.3.12
1.3.13 1.3.14 1.3.15 1.3.16 1.3.17 1.3.18 1.3.19 1.4 1.5 1.5.1 1.5.2
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1-1 1-2 1-3 1-5 1-7 1 - 11 1 - 12 1 - 13 1 - 14 1 - 15 1 - 19 1 - 20 1 - 21 1 - 22 1 - 23 1 - 24 1 - 25 1 - 25 1 - 26 1 - 27 1 - 28 1 - 29 1 - 30 1 - 32 1 - 33 1 - 34 1 - 35 1 - 36 1 - 37 1 - 39 1 - 41 1 - 42 1 - 43 1 - 44 1 - 45 1 - 46 1 - 47 1 - 49 1 - 49 1 - 52
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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1.6 1.7 1.8 1.9 1.9.1
Battery Status LEDs Retractable Power Cord Saline Pole Default Settings User Settings
2
SYSTEM OPERATION
2.1 2.1.1
Operation Instructions Power-Up Procedure Open Helium Tank Valve (If Not Already Opened) and Confirm Helium Pressure Operation Modes Auto Operation Mode Semi Auto Operation Mode ECG Acquisition Use of ECG Skin Electrodes ECG Output from an External Bedside Monitor ECG Troubleshooting Arterial Pressure Acquisition Direct Arterial Pressure Pressure Output from an External Bedside Monitor Pressure Source Troubleshooting Selection of Trigger Source ECG Trigger Pressure Trigger Pacer V/AV Trigger Pacer A Trigger Internal Trigger Trigger Troubleshooting Selection of IAB Frequency Timing of Intra-Aortic Balloon Proper IABP Timing Initiation of Assist IAB Fill Weaning a Patient from IABP Support Pneumatic Module Leak Test Help Screens Alarm and Informational Messages Technical Alarms High Priority Alarms Medium Priority Alarms Low Priority Alarms Informational Messages Sudden Shutdown Alarm Clinical Considerations Water Condensation Clinical Considerations During Operation Use in Electro-Surgical Environment Use During Cardiopulmonary Bypass Detection of Vascular Blood Flow Using the Doppler Printing Printer Operation Printer Formats Trailer Annotations Sample Printer Formats for Waveforms
2.1.2
2.1.3
2.1.4
2.1.5
2.1.6 2.1.7 2.1.8 2.1.9 2.1.10 2.2 2.3 2.4 2.4.1 2.4.2 2.4.3 2.4.4 2.4.5 2.4.6 2.5 2.5.1 2.5.2 2.5.3 2.5.4 2.6 2.6.1 2.7 2.7.1 2.7.2 2.7.3
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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PORTABLE/TRANSPORT OPERATION
3.1 3.2 3.3 3.3.1 3.4 3.5 3.6 3.6.1 3.7 3.8 3.9
Hospital Cart Portable Operation Battery Operation Battery In Use Internal Helium Reservoir Transport Power Supply Operation From a DC-to-AC inverter Specifications for DC Source and Inverter Operation During Air Transportation Removing the Pump Console from the Hospital Cart Transport System
4
USER MAINTENANCE
4.1 4.2 4.3 4.4 4.5 4.6 4.6.1
4.6.2 4.7 4.8 4.8.1 4.8.2 4.9 4.10 4.11 4.12
Chart Paper Loading Installation and Replacement of Helium Tank Helium Tank Refilling Information Installation and Replacement of Batteries Battery Maintenance User Maintenance Between Pumping Procedures Cleaning Cleaning the System Cleaning the Monitor Display and Touchscreen Low Helium Calibrating the Touchscreen Preventive Maintenance Schedules Schedule A Schedule B Emptying Internal Helium Supply Warranty Datascope’s Responsibility Extended Warranty
5
EXTERNAL INTERFACES
5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5
External Monitor Interfacing External Monitor ECG Requirements External Monitor Arterial Blood Pressure Requirements ECG Input from Monitor Pressure Input from Monitor Low Level Pressure Output to Monitor
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ACCESSORIES
6.1 6.1.1
Accessories Shipped with CARDIOSAVE HYBRID CARDIOSAVE HYBRID Accessory Kit Components CARDIOSAVE Blood Pressure Transducer Adapter Cable CARDIOSAVE ECG Operating Room Lead Wires External Signal Cable CARDIOSAVE Battery Pack Helium Tanks
6.1.2 6.1.3
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6-1 6-1 6-1 6-2 6-2 6-2 6-2
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
7
SPECIFICATIONS
7.1 7.2 7.2.1 7.2.2 7.2.3 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.4 7.5 7.6 7.7 7.8 7.8.1 7.8.2 7.9 7.9.1 7.9.2 7.9.3 7.9.4 7.10 7.10.1 7.10.2 7.11 7.11.1 7.11.2 7.11.3 7.11.4 7.12 7.12.1 7.13 7.14 7.14.1
Triggering ECG Channel Patient Lead ECG Input ECG Waveform Display ECG Output Characteristics Pressure Channel IAB Arterial Pressure Transducer Input Arterial Pressure Waveform Display Digital Arterial Pressure Displays High Level Arterial Pressure Output Signal Characteristics Hydraulic Arterial Pressure Zero Low Level Output Signal Characteristics Audible Alarm Level Heart Rate Meter Monitor and Touchscreen Display Characteristics Printer Power Power Requirements Battery Pack Helium Tanks 90 Liter Refillable Helium Tank 99 Liter Refillable Helium Tank 140 Liter Disposable Helium Tank Empty 99 Liter Helium Tank, Refillable Physical Characteristics Weight Dimensions Environmental Requirements Operating Ambient Storage Ambient (IABP Off and not connected to AC power source) Shipping Vibration/Shock Electro-Magnetic Compatibility ESU Rejection Agency Compliance Safety Designations Safety designations per IEC 60601-1 Standard
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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FOREWORD This manual is intended to provide information required to properly operate the CARDIOSAVE IntraAortic Balloon Pump (IABP). For additional information and assistance, please contact the Representative in your area. Information for servicing and repair of CARDIOSAVE is provided in the CARDIOSAVE Service Manual which is made available once the technical representative has been MAQUET Factory Trained and Certified. General knowledge of balloon pumping and an understanding of the features and functions of the IABP are prerequisites for the proper use of this equipment. Therefore, DO NOT OPERATE THE EQUIPMENT BEFORE READING THESE INSTRUCTIONS AND THE WARNINGS, CAUTIONS AND NOTES WHICH FOLLOW. Datascope Corp. maintains a policy of continual product improvement and reserves the right to change materials and specifications without notice. CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner.
WARNINGS, CAUTIONS AND NOTES Please read and adhere to the following list of warnings, cautions and notes; some of which are repeated in the appropriate areas throughout this manual. A WARNING is provided if there is reasonable evidence of an association of a serious hazard with the misuse of this device or when special attention is required for the safety of the patient. A CAUTION is provided when any special care is to be exercised by the practitioner to avoid causing damage to this device or other property. They may also include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury, but about which the user should be aware. A NOTE is provided in the appropriate areas throughout the manual when additional general information is applicable.
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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WARNINGS WARNING: Do not operate this system before thoroughly reading this manual and the associated warnings and cautions. Only use the Quick Reference - Initial Setup Guide if you are already familiar with this product. If not, please continue with the remainder of this manual.
WARNING: Compressed gasses (helium tanks) and Lithium ion batteries are considered Dangerous Goods/ Hazardous Materials per I.A.T.A. and D.O.T. regulations. It is a violation of U.S. federal and international law to offer any package or over pack of dangerous goods for transportation without the package being appropriately identified, packed, marked, classified, labeled and documented according to D.O.T. and I.A.T.A. regulations. Please refer to the applicable I.A.T.A. Dangerous Goods Regulations and/or the Code of Federal Regulations 49 (Transportation, Parts 171-180) for further information.
WARNING: Internal Shock Hazard - This instrument does not contain any user-serviceable parts. DO NOT remove the instrument covers. Refer servicing to MAQUET Factory Trained and Certified Service Personnel.
WARNING: Operation of the IABP below the minimum amplitude or value of PATIENT physiological signal may cause inaccurate results.
WARNING: Disconnect the IAB from the IABP in the event of a sudden shutdown to assure IAB deflation.
WARNING: Use of ACCESSORIES, transducers and cables other than those specified in the manual may result in increased Electromagnetic Emissions or decreased Electromagnetic Immunity of the IABP. It can also cause delayed recovery after the discharge of a cardiac defibrillator.
WARNING: The IABP should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IABP should be observed to verify normal operation in the configuration in which it will be used.
WARNING: Do not use the IABP near an MRI (Magnetic Resonance Imaging) scanner or during an MRI scan.
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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WARNING: Pneumatic Module Leak Test MUST NOT be performed with the pump connected to a patient's IAB.
WARNING: The System Trainer MUST NOT be connected to a IABP while it is being used for patient therapy.
WARNING: Re-evaluate and, if necessary, readjust inflation and deflation timing after each manual pressure trigger threshold change.
WARNING: The Augmentation Alarm, which is automatically set at power-up, provides back-up to IAB alarms (gas loss and IAB catheter alarms) at higher heart rates. Therefore, this alarm should not be manually disabled.
WARNING: Preventive Maintenance should never be performed when the IABP is attached to a patient.
WARNING: System Configuration mode is not for clinical use.
WARNING: To ensure proper system performance and guarantee defibrillator protection, only Datascope Corp. approved cables, accessories, including lead wires, Intra-Aortic Balloons (IABs), System software, and Pneumatic Module assemblies should be used with the IABP.
WARNING: Do not inflate the IAB using a syringe or any other means if a balloon leak is suspected.
WARNING: Perforation of a balloon may indicate that the patient’s vascular condition may induce abrasion or perforation in subsequent balloons.
WARNING: The patient balloon should not remain inactive in the patient (i.e., not inflating and deflating) for more than 30 minutes, due to the potential for thrombus formation.
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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WARNING: Do not leave the patient unattended during IABP therapy.
WARNING: External bedside monitors used to supply the ECG signal to the IABP in the operating room must be equipped with electro-surgical interference suppression.
WARNING: Use surgical gloves while replacing Pneumatic Module to avoid contact with residual condensate or other body fluids. Disposal of the used safety disk within the Pneumatic Module should be in accordance with prevailing hospital practices for medical refuse.
WARNING: Under no circumstances should an IAB patient or the IABP ever be placed in a hyperbaric chamber.
WARNING: Stabilize the patient's heart rate below 210 bpm to avoid the system triggering on alternate ECG complexes. Inflation may extend into the next cardiac cycle if such trigger conditions exist.
WARNING: Route cables neatly. Ensure cables, hoses and wires are away from patient's neck to avoid strangulation. Keep floors and walkways free of cables to reduce tripping hazard for hospital personnel, patients and visitors.
WARNING: Under certain heart rate and timing conditions catheter alarms may be suspended. Refer to this manual for further details.
WARNING: External monitor output signals must meet certain requirements. See External Monitor Interfacing in section 5.1.
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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WARNING: This unit uses a common isolation path for the ECG leads and the Invasive Pressure Channels. Ensure that conductive parts of the ECG electrodes do not contact other conductive parts including earth ground. Do not connect any non-isolated accessories to the IABP or to the ECG or invasive pressure channel inputs when connected to a patient. Insure that the total chassis leakage currents of all connected units does not exceed 300μA. Use an IEC 60601-1 approved isolation/separation transformer if required. Do not simultaneously touch the patient and any piece of electrical equipment if any cover has been removed from the equipment.
WARNING: The AC power cord and interface cables (i.e., non-patient cables) may utilize the same ground. Therefore, removal of the AC power cord does not necessarily isolate the IABP, if non-patient interface cables are attached.
WARNING: Observe extreme caution when a defibrillator is used on a patient. Do not touch any part of patient, table or IABP when a defibrillator is in use.
WARNING: Do not put MPSO (Multiple Portable Socket Outlets i.e., Multiple outlet extension cords) used with the IABP or its accessories on the floor. Connect only IABP accessories to the same MPSO as the IABP. Do not overload the MPSO. Do not connect other equipment to the same MPSO with the IABP, as it may increase system leakage current.
WARNING: Reliably attach Potential Equalization connector to the safety ground when interconnecting IABP with other medical or non-medical electrical equipment to minimize the risk of excessive leakage current and/or shock hazard.
WARNING: Do not reuse disposable devices.
WARNING: Pacemaker Patients: Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Keep pacemaker patients under close surveillance. See the Selection of Trigger Source section of the System Operation chapter for disclosure of the pacemaker pulse rejection capability of this instrument.
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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WARNING: Pressure triggering is NOT recommended for use when sustained irregular cardiac rhythms or tachyarrhythmia’s are present. Remember to adjust deflation early enough so that deflation is completed prior to systole and to provide continuous observation while triggering from a pressure source. If an “Irregular Pressure Trigger Detected” informational message appears, DO NOT attempt to adjust the deflation control as the system will automatically compensate by deflating earlier to avoid interfering with systolic ejection.
WARNING: Only personnel familiar with the handling of high pressure gas tanks should install or replace the helium tank.
WARNING: When pressure is being used as the trigger source, balloon deflation should always be adjusted to be complete at the upstroke of systole. Late deflation timing causes a reduction in, and delay in detection of, systolic pulse pressure. The system relies on a prominent and timely systolic upstroke for consistent, reliable pressure triggering. Any overlap of balloon deflation and systolic ejection, while pressure is the trigger source, could cause triggers to be late or missed, potentially resulting in loss of synchronization.
WARNING: The user should continually rely on visual alarm messages during high noise transport situations.
WARNING: Continued assist of an IAB which has a leak may result in formation of a large blood clot within the balloon. This may cause balloon entrapment which may require surgical removal of the IAB.
WARNING: Do not remain in the internal trigger mode when the patient is generating a cardiac output.
WARNING: When weaning by reduced IAB augmentation, do not reduce augmentation to a point at which the IAB status indicator moves less than 50%.
WARNING: If possible, use ECG or Arterial Pressure trigger during CPR. This facilitates synchronization of the assist to the rate and rhythm of chest compressions. In Auto OPERATION MODE, the ECG (RWave) or Arterial Pressure signal will automatically be selected as the trigger source. Choice is dependent upon relative signal quality. If neither the ECG nor the Arterial Pressure signals produce adequate trigger reliability to allow for Auto Operation, the IABP may be triggered by its own internal clock. Select Semi Auto OPERATION MODE and set the Trigger Source to Internal. CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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WARNING: If the Manual pressure trigger threshold option is used, the threshold must be adjusted whenever persistent changes in systolic pulse height occur. Height changes may be due to changing patient conditions or may occur following the pump's initial calibration of a Fiber-Optic IAB. Always reevaluate inflation and deflation timing after making adjustments to the trigger threshold for any reason.
WARNING: If more than one pump is being used in close proximity, ensure that the source of the alarm sound is correctly identified by confirming the corresponding visual indication.
WARNING: Do not simultaneously connect the Hospital Cart Power Supply and the Transport Power Supply to AC power sources to prevent excessive electrical noise and interference with signal detection.
WARNING: Removing both batteries or removing the energized battery, when AC power is not connected, will stop the therapy, (i.e., power down the pump).
WARNING: Sufficient additional charged batteries should be on hand during transport to prevent IABP shutdown due to inadequate battery capacity.
WARNING: A patient must not be connected to the IABP during operation in System Diagnostic mode to avoid potential for injury.
WARNING: Batteries have the risk of fire, explosion or severe burn hazards. Do not disassemble, crush, heat above 60° C (140° F), or incinerate. Replace only with Datascope Corp. REF 0146-00-0097.
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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CAUTIONS CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner.
CAUTION: Blood pressure transducers used with the IABP shall meet the standard for interchangeability and performance as defined by ANSI/AAMI BP22:1994/(R) 2006, Blood Pressure Transducers.
CAUTION: The operator is urged to routinely check the IAB catheter extender for the formation of condensate. If excessive condensation is allowed to accumulate it will affect system performance. Excessive condensate may indicate the need to service the Pneumatic Module.
CAUTION: System batteries must be properly maintained and periodically tested. See the Battery Section of the User Maintenance Chapter.
CAUTION: A battery can only charge when the AC plug is connected to a live AC receptacle and the battery charging status LED is flashing. This charging condition must be maintained even when the system is not in use. The battery charging status LED will stop flashing and remain illuminated when the batteries are fully charged. If the system is to be stored for extensive periods of time, or in ambient temperatures above the operating range, refer to the Battery Section of the User Maintenance Chapter.
CAUTION: After being stored at low temperature, allow CARDIOSAVE to be exposed to room temperature for at least 30 minutes before operating on battery power.
CAUTION: Use medical grade helium only.
CAUTION: When power cycling the unit, power off for a minimum of 10 seconds before powering on again.
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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CAUTION: Prior to emergency use, when the System is to be powered from an AC inverter, the inverter should be checked for proper operation with the System by qualified maintenance personnel. The message “Battery in Use” will not be displayed during proper AC inverter operation.
CAUTION: Conductive parts of electrodes and associated connectors for applied parts, including the neutral electrode, should not contact other conductive parts including earth.
CAUTION: Never place fluids on top of this unit. Make sure that the saline container and tubing do not hang directly over the IABP. In case of accidental spillage, wipe clean immediately and have the unit serviced to ensure no hazard exists.
CAUTION: Do not use a damaged or broken unit or accessory.
CAUTION: Do not operate the unit with the ventilation or speaker vents obstructed.
CAUTION: To prevent condensation, allow the IABP to warm up and dry if it is moved from a cold area to a warm one.
CAUTION: The highlighted inflation interval marker should not be used to set timing. Timing should be set by examination of the Arterial Pressure Waveform.
CAUTION: The displayed ECG signal is automatically scaled (amplified) for optimal screen presentation. Due to the automatic scaling, low ECG amplitudes may appear to be of normal amplitude when displayed. Judgments concerning ECG amplitude should be made with reference to the annotated scale.
CAUTION: The displayed AP signal is automatically scaled (amplified) and offset for optimal screen presentation. Because of automatic scaling, low AP amplitudes may appear to be of normal amplitude when displayed. Judgments should be made with reference to the annotated scale, patient arterial pressure parameter display.
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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CAUTION: The helium tank valve may be left open when the system is not in use, providing the tank has been properly installed and remains leak free.
CAUTION: To ensure reliable operation of the Autofill system and proper IAB inflation pressures, it is important that the combined total volume of the IAB’s membrane and extracorporeal tubing, plus the catheter extender tubing, is not altered. Using tubing of a different length or internal diameter from that supplied with MAQUET/Datascope Corp. IAB products will change IAB inflation pressure levels and may result in Autofill failures. Consequently, such practices must be avoided.
CAUTION: Ensure that the wheels of the cart are in the locked position when removing the pump Transport Module from the cart or returning the pump Transport Module to the cart.
CAUTION: Lifting the Cart with IABP by the Front and Back Handles requires two people.
CAUTION: During or after any surgery that results in a 6°C or more change in patient core temperature in less than 2 hours, the Fiber-Optic IAB should be recalibrated by pressing and holding the Calibrate Pressure key for 2 seconds while assisting.
CAUTION: The Saline Pole is not intended for use as a handle or lift point. When transporting or moving the System, use only the cart handle.
CAUTION: The pull up handle must not be used to lift the Transport System. Use only designated lift points and handles.
CAUTION: Secure the system during transport to prevent impact injuries.
CAUTION: When AC power operation is intended, insure that the system is plugged into a live AC receptacle and that the “Battery in Use” informational message is NOT displayed.
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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CAUTION: This product requires scheduled preventative maintenance in order to maintain its specified performance. Note that maintenance includes periodic cleaning to assure that proper cooling airflow of the system’s electronics is maintained.
CAUTION: Do not set the alarm volume to such a low level that it cannot be readily heard over the ambient noise level of the venue in which the IABP is used.
CAUTION: Do not touch the exposed end of the Fiber-Optic IAB cable, or permit it to contact other surfaces. This could damage or contaminate the sensor connection.
CAUTION: The Touchscreen is a pressure sensitive surface that should not be in contact with sharp objects or harsh chemicals. CAUTION The internal helium tank contains 200 PSI of helium. This tank MUST be emptied prior to shipping the system via commercial shipping. CAUTION Prior to shipping CARDIOSAVE via commercial shipping the batteries MUST be removed. CAUTION CARDIOSAVE batteries MUST be shipped through a shipper that has expertise in the shipping of dangerous goods. Packaging for battery shipments MUST be packed and labeled appropriately. Contact MAQUET for further instructions on returning batteries.
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.
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INDICATIONS FOR USE The balloon pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The target population is adult. The balloon pump is intended for use in the health care facility setting.
CONTRAINDICATIONS ■ Severe aortic insufficiency ■ Abdominal or aortic aneurysm ■ Severe calcific aorta-iliac disease or peripheral vascular disease ■ Introduction of the IAB catheter without the use of an introducer sheath is not recommended for
patients with severe obesity, scarring of the groin or other contraindications to percutaneous insertion
Note: CARDIOSAVE is not intended to perform patient monitoring functions.
CARDIOSAVE | Operating Instructions | English | 0070-00-0638-01 Copyright Datascope Corp.