advertisement
▼
Scroll to page 2
of 200
PERFORMER™ CPB c PERFORMER™ CPB An Advanced Extracorporeal Circulatory Support System Operator’s Manual Distributed Exclusively by Medtronic, Inc. Manufactured by RanD S.r.l. Medolla (MO) Italy c PerformerV1.5_EN_SYM.fm 3/4/08 Medtronic Confidential CS017 3:02 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Explanation of symbols on package labeling Refer to the package label to see which symbols apply to this product Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Council Directive MDD 93/42/EEC (14 June 1993, concerning medical devices) and amendments. 0123 Caution, Consult Accompanying Documents Serial Number Lot Number Quantity For US Audiences Only Date of Manufacture Temperature Limitation Humidity Limitation Catalog Number Manufacturer Fuse Alternating Current Type BF Equipment High Voltage Medical equipment with respect to electrical shock fire, and mechanical hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1, IEC 60601-2-16 71NL. This Way Up Fragile, Handle with Care xx Kg Maximum Weight MAX Do not dispose of this product in the unsorted municipal waste stream. Danger: Risk of explosion if used in the presence of flammable anesthetics. Equipotentiality Level Sensor Remote Tube Clamp VARD Operator’s Manual A14113002 Rev. 2.0 i PerformerV1.5_EN_SYM.fm 3/4/08 Medtronic Confidential CS0023 3:02 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Bio-Pump Flowmeter/ABD Class II (Double Insulated) Equipment Open Here Warning, Crushing Hazard: Finger Pneumatic Pressure Range Atmospheric Limitation ii A14113002 Operator’s Manual Rev. 2.0 PerformerV1.5_TOC.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Table of Contents 1 Introduction 1-1 System Description 1-2 System Overview 1-2 Indications for Use 1-5 Contraindications 2 Warnings 1-5 Cautions 1-9 1-5 Safety 2-1 Safety Standards 2-2 Disposables and Accessories Main Power Supply Failure 2-2 2-2 Electromagnetic Disturbance 2-3 Elimination of the Disposable Material 2-3 End of Life Disposition 2-3 Calibration 2-3 Technical Documentation Replacing Fuses 2-3 Equipotential Connection Battery Pack Disposal 3 2-3 2-4 2-4 Technical Specifications 3-1 General Data 3-2 Technical Features 3-3 Electromagnetic Emissions and Immunity Declarations 3-6 Monitoring System for Hematocrit, Temperature and O2 Saturation Temperature Probes 3-10 3-11 Battery Supply System (UPS) 3-11 IEC 60601-2-16 Compliance Chart 3-12 4 Installation 4-1 Installation 4-2 Installation Checklist and Commissioning 5 4-3 Instructions for Use 5-1 Console 5-2 Roller Pump, Roller Inserts, Tube Inserts, and Tubing System Configuration System Start-up 5-35 Main Run Screen Timers 5-6 5-16 5-41 5-46 Cardioplegia 5-49 AAR Controller - Venous Air Removal Device (Resting Heart mode only) Air Detection 5-58 5-63 Operator’s Manual A14113002 Rev. 2.0 iii PerformerV1.5_TOC.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Table of Contents Level Sensing System (Bio-Pump CPB mode only) AutoClamp System (Bio-Pump CPB mode only) Pressure Mode Selection 5-84 Venous Saturation and Hematocrit Monitoring Options Menu Screen 5-67 5-73 5-90 5-94 Servo (Resting Heart mode only) 5-104 Preparing for Cardiopulmonary Bypass Checklist 5-109 Initiating Extracorporeal Support Checklist 5-112 6 Cleaning and Maintenance Cleaning 6-1 6-2 Maintenance 6-2 7 Troubleshooting 7-1 General Information 7-2 Emergency Procedures Alarms Alerts 8 A14113002 Rev. 2.0 7-20 7-27 Warranty 8-1 IMPORTANT NOTICE - LIMITED WARRANTY 8-2 IMPORTANT NOTICE - LIMITED WARRANTY 8-3 A Index iv 7-4 Operator’s Manual A-1 PerformerV1.5_BkTpEN.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) PERFORMER™ CPB Operator’s Manual A14113002 Rev. 2.0 0 PerformerV1.5_BkTpEN.fm 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) A14113002 Rev. 2.0 Medtronic Confidential CS017 PerformerV1.5_EN_1.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Introduction 1 System Description 1 1-2 System Overview 1-2 Indications for Use Contraindications Warnings 1-5 Cautions 1-9 1-5 1-5 Operator’s Manual A14113002 Rev. 2.0 1-1 PerformerV1.5_EN_1.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 1 System Description System Description The Performer™ CPB System, hereafter referred to as the Performer CPB, is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. It is an integrated console that can provide total circulatory support of the cardiopulmonary system using the Medtronic® Bio-Pump® Centrifugal Blood Pump, hereafter referred to as the Bio-Pump. System Overview Total extracorporeal support of the cardiovascular system is accomplished by using the Bio-Pump® Centrifugal Blood Pump. The Bio-Pump is the exclusive device on the Performer CPB for generating arterial flow up to 10.0 liters per minute (L/min). Bio-Pump flow is achieved by adjusting the pump speed RPM knob on the front panel of the Performer CPB console. Flow measurement is accomplished using a reusable ultrasonic flow transducer that is noninvasively attached to the arterial line of the extracorporeal circuit. The detected flow is displayed on the front panel of the console (red LED) and on the Main Run Screen of the Central Information Display (CID). The pump speed RPM knob has a minimum RPM mechanical stop, or detent, that prevents an unintentional reduction of RPM below 2000. The user must press down on the detent lever while turning the knob counterclockwise to purposefully reduce the RPM below 2000. The minimum RPM detent lever does not affect increasing the RPM. Integral to the Performer CPB are four roller pumps, each with an independent Start/Stop button, a 3-turn roller speed control knob and a LCD for monitoring flow or RPM. The roller pumps are indicated for moving fluids through an extracorporeal circuit that incorporates a flexible tube. The roller pumps are not indicated for use in supporting flow through arterial circuits. Two small roller pumps (PM4 and PM3) generate low flow for cardioplegia delivery, hemoconcentration, or other auxiliary applications. PM4 is a deep-well pump capable of accommodating two tubes of same or different dimensions and is capable of a maximum flow of 1.1 L/min. PM3 accommodates one tube and is capable of a maximum flow of 0.6 L/min. PM3 and PM4 can be configured via the CID so that both pumps operate in tandem, with PM4 designated as the master pump and PM3 designated as the slave pump. The master pump Start/Stop button and pump speed RPM knob operate both pumps. Two large roller pumps (PM1 and PM2) generate flow for cardiotomy suction, left heart venting, or auxiliary application. PM1 is a low torque/high speed roller pump with a maximum flow capacity of 3.7 L/min. PM2 is a high torque/mid-flow roller pump with a maximum flow capacity of 1.5 L/min. The interchangeable roller pump inserts are factory calibrated for providing optimal occlusion for standard sizes of polyvinyl chloride (PVC) tubing available for medical use. Factory-calibrated roller pump inserts are also available when using 2 tubes in a single raceway. The Performer CPB provides perfusion monitoring via: Pressure monitoring transducers for up to 8 pressures including venous line, arterial line, cardioplegia delivery, AAR suction, vent line, sucker line, syringe, and one user-defined. 1-2 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_1.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Introduction System Overview Temperature monitoring using YSI™1 Series 400 probes for 8 temperatures including venous line, arterial line, cardioplegia delivery, and the remainder user defined. Flow monitoring for the arterial line using a reusable Transonic™2 ultrasonic flow probe, which noninvasively connects directly to the arterial line tubing. This flow probe also serves to detect backflow in the arterial circuit. Flow data combined with patient body surface area entered in the CID also provides for continuous monitoring of cardiac index. Oxygen saturation and hematocrit monitoring using an opto-electric sensor, which couples with a dedicated disposable cuvette that is integrated into the extracorporeal circuit. This data, in combination with the information obtained from the flow transducer, is used to calculate and display oxygen consumption on the CID. Timers for pump time, clamp time, and cardioplegia delivery times and intervals. The CID enables the user to interact with the Performer CPB equipment. It consists of a 30.73 cm (12.1 in) color graphic display (256 colors, 800 x 600 pixel) in combination with a touch screen system to activate the various functions represented on the screen. The display is divided into well-defined zones for the individual perfusion modes and uses unique graphic pictures and icons to display information. Critical information areas are always visible. The touch screen display allows the user to: ■ display all desired perfusion parameters ■ input patient information ■ configure pump responses to activation of safety devices and events that occur during bypass ■ set safety alert and alarm limits ■ display graphical trending of data ■ select cardioplegia delivery modes ■ read message alarms and warnings ■ select audible alert and alarm tones The CID and the console incorporate distinct visual and audible cues intended to elevate the user's awareness when a safety sensor is activated and when user-defined or default operational limits of a system are exceeded. The Performer CPB enables the user to configure integrated safety links between the following safety sensors and the Bio-Pump and the roller pumps: 1 2 ■ Air Bubble Detection (ABD) of macro-air in the arterial circuit is integral to the ultrasonic flow monitoring system. The system can be configured by the user to cause the Bio-Pump to either Stop or Coast in response to this sensor being activated and prevent transmission of air to the patient. The user can also configure this safety link to not change the Bio-Pump function, but only produce visual and audible alarm cues. ■ Air bubble detection of macro-air in the cardioplegia circuit, using an ultrasonic transducer mounted to the side of the console that couples directly to the cardioplegia delivery tubing. The user can configure the cardioplegia delivery pump (PM4) to either Stop or Pause in response to this event and prevent transmission of air to the heart. The user can also configure this safety link to not change the roller pump function but only produce visual and audible alarm cues. YSI™ is a registered trademark of YSI Incorporated. Transonic™ is a registered trademark of Transonic Systems Inc. Corporation. Operator’s Manual A14113002 Rev. 2.0 1-3 PerformerV1.5_EN_1.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 1 System Overview ■ Active Air Removal (AAR) technology integral to the Performer CPB is used in conjunction with a dedicated disposable Venous Air Removal Device (VARD) for venous air sensing and automatic removal. This prevents air entering the venous line from reaching the Bio-Pump and potentially being transmitted to the patient. The Active Air Removal (AAR) technology with the VARD is only utilized when operating the Resting Heart mode. ■ Level Detection utilizes a pair of level sensors to monitor changes in fluid or blood volume in reservoirs. The system can be configured by the user to cause the Bio-Pump to either Stop or Coast in response to a level sensor being activated, preventing emptying the reservoir and transmitting air into the circuit. The user can also configure this safety link to not change the Bio-Pump function, but only produce visual and audible alarm cues. The level detection system is only utilized when operating in the Bio-Pump CPB mode. ■ An AutoClamp System utilizes a pneumatically-powered Remote Tube Clamp (RTC) that is placed on the arterial line and serves to prevent retrograde flow from the aorta into the venous reservoir if the Bio-Pump run mode changes. When the Bio-Pump enters either the STOP or COAST mode, or the pump speed is manually reduced to 2000 RPM, there exists the potential for arterial retrograde flow and entrainment of air into the arterial line from around the aortic cannulation site. This poses a hazard to the patient if the pump is restarted before air is removed. The AutoClamp System can be configured to automatically clamp the arterial line when the Bio-Pump speed changes, prevent retrograde flow and thereby prevent the potential to entrainment air around the aortic cannulation site. The AutoClamp System is only utilized when operating in the Bio-Pump CPB mode. ■ Pressure transducers enable user-defined alert and alarm limits for arterial line pressures, venous line pressures, cardioplegia pressures, as well as the individual roller pump pressures. The Performer CPB provides an uninterruptible power supply (UPS) that will provide battery power to operate the system for a minimum of 30 minutes with a fully loaded system (see page 5-44) in the absence of line power. Additional user conveniences include: 1-4 A14113002 Rev. 2.0 ■ Cardioplegia delivery configuration options to select automatic shut off of the cardioplegia pump to user-defined volume or time delivery parameters and a user-defined option for two-pump blood and drug proportioning from 0:1 (pure drug) to 15:1. ■ Graphic trending of flow, cardiac index, venous saturation, hematocrit, pressure, and temperature data. ■ Capability to auto-regulate the speed of the Bio-Pump to maintain a desired venous line pressure. This function is particularly useful when operating the Medtronic® Resting Heart™ System and optimizing the relationship between blood flow and left heart emptying. ■ An integrated printer to generate hard copy records. ■ A removable data storage card that allows perfusion and system information to be stored electronically and then later formatted for generating reports. ■ Electric powered height adjustment for optimal operation, transport, and storage. Operator’s Manual PerformerV1.5_EN_1.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Introduction Indications for Use Indications for Use The Medtronic® Performer™ CPB Advanced Extracorporeal Circulatory Support System is indicated for use up to 6 hours in the extracorporeal circulation of fluids for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The Bio-Pump® Centrifugal Blood Pump is indicated for use in pumping blood through an extracorporeal perfusion circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours). Contraindications The device is not designed, sold, or intended for use except as indicated. The centrifugal pump is contraindicated for use as a cardiotomy suction device. Warnings General ■ The user must read and understand all information in the Operator's Manual prior to use. Failure to read and follow all instructions, or failure to observe all stated warnings, could cause serious injury or death to the patient. ■ Only trained and qualified medical personnel should operate and monitor the Performer CPB. ■ Use the system and any attached devices according to the manufacturer's instructions and good medical practice. ■ The system is qualified only for durations appropriate to cardiopulmonary bypass procedures. It has not been qualified, either through in-vitro, in-vivo, or clinical studies, for use beyond 6 hours. ■ The Performer CPB enables the user to change the configuration of the default factory settings. Reconfiguration in regards to how components respond to events and assurance that users are properly trained to operate the Perfusion Screens must be appropriately controlled by the user institution. Failure to establish such controls may result in user error that could result in patient injury or death. ■ Following standard practices for electronic devices, closely monitor the system when exposure to intense electrical noise or fluctuating line voltage occurs. Strong electromagnetic fields emitted from other equipment in the operating room (OR) (internal and external defibrillators, electrocautery devices, etc) or fluctuations in the alternating current (AC) power line voltage may compromise performance or damage the equipment. ■ Portable and mobile radio frequency (RF) communication devices may affect the operation of this system. (See “Electromagnetic Emissions and Immunity Declarations” on page 3-6.) ■ A standby Bio-Console® Extracorporeal Blood Pumping Console should be available during cardiopulmonary bypass procedures. ■ Maintain a minimum Bio-Pump speed or clamp the pump outlet line to prevent backflow. ■ Do not kink the VARD sensor cable. Operator’s Manual A14113002 Rev. 2.0 1-5 PerformerV1.5_EN_1.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 1 Warnings ■ Do not allow fluids to come into contact with the cable connections. ■ To prevent backflow of the patient's blood when the pump outlet tubing is open, establish and maintain a minimum pump speed that overcomes line and patient resistance. Failure to do this could allow retrograde flow and exsanguinate the patient. ■ All gaseous bubbles have the potential for gaseous emboli and must be dealt with carefully. Use of Safety Devices (Arterial Line Air Bubble Detector, VARD, Level Detection, AutoClamp) and Safety Systems (Bio-Pump Backflow Alert) is recommended to aid in the detection and elimination of gaseous bubbles in the extracorporeal circuit. ■ When handcrank operation of a roller pump is necessary due to a failure of the motor or motor controller, the roller pump digital display may remain illuminated. Any RPM/flow values that are being displayed will not correlate to the manual RPMs or flow generated using the handcrank. ■ A fluid isolator is necessary in the pressure monitoring line to prevent contact of sterile fluid path with the instrument and damage to the instrument and pressure system. ■ Do not bypass the fluid isolator/filter in the pressure lines for the pressure connectors (PR1 through PR8, ALP, and VLP) or fluid could enter the transducer and damage internal components. ■ Do not introduce fluid into the male pressure luer connections on the console. ■ Do not connect the external temperature probes in conjunction with electrocautery usage; this may compromise the temperature values measuring. ■ The device has been designed and tested in conformity with the Electro-Magnetic Compatibility standard EN60601-1-2 (2003). It is advisable, however, to avoid its use in the presence of electromagnetic fields or other equipment causing interference (eg, cellular phones). Special information regarding installation, use, and precautions are described in “Electromagnetic Emissions and Immunity Declarations” on page 3-6. ■ The utilization of other manufacturers' probes (eg, flow and temperature) may jeopardize the performance of the device and, as a consequence, the measurement reliability. ■ The equipment is not protected against defibrillator discharges. ■ Do not operate the Active Air Removal (AAR) system with device or components other than the Medtronic® Resting Heart™ Module. There are no safety or performance data known to Medtronic that establish compatibility of any other manufacturer's device or components with the AAR system. Any substitution of components becomes the responsibility of the user. Such substitution will void Medtronic's warranty and the user will bear full responsibility for any adverse consequences stemming from such use. ■ Do not use the integrated AAR Controller until proper operating conditions are verified. Prior to each use, it is the responsibility of the user to determine that the system is in proper operating condition as described in this manual. ■ To prevent backflow of the patient's blood when the pump outlet tubing is open, establish and maintain a minimum pump speed that overcomes line and patient resistance. Use the AutoClamp System on the arterial line. Failure to do this could allow retrograde flow and introduce air into the arterial circuit. AAR Controller AutoClamp System 1-6 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_1.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Introduction Warnings ■ Prior to configuring the Arterial AutoClamp to CLOSE when the Bio-Pump enters the COAST mode, it is the user's responsibility to test their extracorporeal circuit and confirm the conduct of perfusion at their institution does not generate arterial backflow when the Bio-Pump enters the COAST mode or the Bio-Pump speed is manually reduced to the “detent” position. ■ If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY ABD” alarm, pump RPM will remain at 2000 and will not automatically ramp up after the air is no longer detected by the ABD or after the ABD is turned off. Flow can only be resumed manually after careful assurance that air has been completely removed from the arterial circuit. ■ If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY ABD” alarm and the AutoClamp is configured to CLOSE, the AutoClamp will not automatically OPEN after Bio-Pump flow is resumed. The user must manually press the AutoClamp button on the Main Run Screen to open the clamp after careful assurance there will be forward flow. ■ The Self Test must be performed prior to each use of the device. If the AutoClamp System does not operate as described during the Self Test, do not use the AutoClamp System. Contact Medtronic Service. ■ Resume flow only after careful assurance there is no air in the arterial circuit. ■ Ensure the air pressure to the AutoClamp System is within the range specified in Chapter 3. ■ If a partially charged battery is used, there may be less than 30 minutes of battery power available. ■ When the Uninterruptable Power Supply (UPS) converts the system to battery power, ALL pumps, pump functions, safety systems, alerts, alarms, monitors, controls, the Pinch Valve and the Central Information Display (CID) are active and function the same as when the system is on AC power. ■ Ensure that the Main Power switch is off before storage, inspection, cleaning, and preparation for use to disable both the battery power and wall AC power. Battery/UPS Main Power Switch Central Information Display (CID) 3 ■ If the CID fails during a procedure, the Performer CPB can be operated through the local controls for the roller pumps and the Bio-Pump. ■ If the CID fails during a procedure, the sensors that have safety connections with the Bio-Pump will remain enabled. The sensors that detect and measure blood flow, Arterial Line Pressure (ALP), Venous Line Pressure (VLP), Venous Saturation (SvO2), Hematocrit (Hct), Revolutions Per Minute (RPM), and Cardioplegia Pressure can be displayed by scrolling through the Liquid Crystal Display (LCD) display on the Bio-Pump control panel on the front of the console. ■ If the CID fails during a procedure, DO NOT turn the system power off as this will cause all settings and device assignments to be lost. ■ The CID must be in the Home Screen for data to be downloaded into the CompactFlash®3 memory card. After the CID is changed to the Home Screen, allow a minimum of 10 seconds for the data download to complete before removing the CompactFlash® memory card. CompactFlash® is a registered trademark of SanDisk Corporation. Operator’s Manual A14113002 Rev. 2.0 1-7 PerformerV1.5_EN_1.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 1 Warnings ■ Using the Pre-Cardiopulmonary Bypass Parameters Screen with the alpha-numeric keyboard during the conduct of cardiopulmonary bypass will cover essential perfusion and cardioplegia delivery information screens. Enter data prior to initiating bypass. Do not use during bypass. ■ Tubing must not be reversed in the roller pump as air embolism may occur. ■ Use only tubing of the material and sizes specified for this system. ■ Set the roller pump to the Stop Mode before installing tubing. ■ The roller pump safety cover interlocks are not enabled until after the Resting Heart™ Screen is opened. Ensure that the roller pump safety covers remain closed during the Power On Self-Test (POST). ■ The roller pump safety cover interlocks are not enabled until after the Resting Heart™ Screen is opened. Ensure that the roller pump safety covers remain closed when in the Emergency Mode. ■ The roller pump safety cover interlocks are not enabled until after the Resting Heart™ Screen is opened. Ensure the roller pump safety covers remain closed if roller pump function is required before enabling the Resting Heart™ Screen. ■ If handcrank operation is necessary due to the loss of AC and battery power, flow detection and safety systems are inoperable. Closely monitor the circuit to prevent introduction of air. ■ If air enters the Bio-Pump, stop perfusion as gaseous emboli may be introduced into the patient. ■ If the Bio-Pump stops, immediately clamp the arterial line and venous line. Check for air in the arterial line that may have resulted from backflow. If air is visible, remove from the arterial circuit before resuming bypass. ■ If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY ABD” alarm, pump flow will remain at 0.5 L/min and will NOT automatically ramp up after the air is no longer detected by the ABD or after the ABD is turned off. Flow can only be resumed manually after careful assurance that air has been completely removed from the arterial circuit. Tubing Roller Pump Handcrank Bio-Pump Power On Self-Test (POST) ■ Bypassing the POST when a system has failed may cause error messages or malfunction during use. ■ If the POST repeatedly produces a FAILED indication, contact a Medtronic service representative. Air Bubble Detector (ABD) ■ 1-8 A14113002 Rev. 2.0 Operator’s Manual A gray icon (with a red X) for the Arterial Line Air Bubble Detector icon indicates the sensor is DISABLED and will not generate an alarm if air enters the arterial circuit. PerformerV1.5_EN_1.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Introduction Cautions ■ The Air Bubble Detector (ABD) sensor must be positioned at a sufficient distance from the patient to allow the air detection system sufficient time to respond before air can reach the patient. ■ The ABD sensor latch must be completely closed to secure the sensors to the tubing. ■ The ABD sensor must be positioned so the cable is between the tubing and the floor. ■ The performance of the ABD must be verified before each use. ■ A gray icon (with a red X) for the Cardioplegia (CPG) Air Bubble Detector icon indicates the sensor is DISABLED and will not generate an alarm if air enters the cardioplegia circuit. ■ Do not use sharp instruments on the CID, Bio-Pump control panel scroll arrows, or the roller pump Start/Stop button as these may damage the device. Restrict touching the screen with fingers only. ■ Installing the Bio-Pump with the motor revolving may damage the Bio-Pump. ■ When assembling the Bio-Pump Centrifugal Blood Pump, Model BPX-80, for use with the Performer CPB, do not use alcohol or alcohol-based fluids. Do not expose to chemical agents as they may affect the integrity of these devices. Anesthesia solutions such as FORANE4 are known to degrade polycarbonate plastics. Avoid contact of these solutions with the BPX-80 Bio-Pump. ■ Using the Bio-Pump beyond labeled recommendations may result in failure of the centrifugal blood pump, reduced pumping capacity, leaks, excessive blood trauma, and degradation or corrosion of blood contact materials, which may pass through the blood to the patient. ■ Refer to the instructions included with the Medtronic® Resting Heart™ System or specific manufacturers’ disposable circuits. ■ Maintain a minimum pump speed or clamp the circuit's arterial line to prevent arterial backflow. ■ If the pressurized gas fails or the air hose is disconnected, the Remote Tube Clamp (RTC) will close. ■ Do not drop the O2Sat/Hct sensors as shock may damage the sensor. ■ Do not adjust the occlusion setting on the roller pump insert; doing so will void the warranty. ■ Ensure the castor brakes are engaged before use. ■ When transporting the machine, reduce the equipment’s height to the lowest position to avoid tipping. ■ Only ship the Performer CPB in a Medtronic-approved crate. Contact your service personnel for the correct procedure. ■ After each use, clean the device as per the instructions on page 6-2 and ensure all components are in proper working condition. Cautions 4 FORANE® is a registered trademark of ATOFINA. Operator’s Manual A14113002 Rev. 2.0 1-9 PerformerV1.5_EN_1.fm 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 1 Cautions 1-10 A14113002 Rev. 2.0 Operator’s Manual Medtronic Confidential CS0023 PerformerV1.5_EN_2.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Safety 2 2 Safety Standards 2-2 Disposables and Accessories 2-2 Main Power Supply Failure 2-2 Electromagnetic Disturbance 2-3 Elimination of the Disposable Material 2-3 End of Life Disposition 2-3 Calibration 2-3 Technical Documentation Replacing Fuses 2-3 2-3 Equipotential Connection 2-4 Battery Pack Disposal 2-4 Operator’s Manual A14113002 Rev. 2.0 2-1 PerformerV1.5_EN_2.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 2 Safety Standards ATTENTION: The Performer CPB must be operated only by skilled personnel trained for this task and in conformity to the present Operator’s Manual. Safety Standards The Performer CPB equipment complies with the essential requirements of the Directive on Medical Devices 93/42 EEC (CE 0123) The Performer CPB equipment also complies with the following international standards: Manufacturing safety, electrical safety: ■ IEC 60513 ■ IEC 60529 ■ EN 60601-1 ■ EN 60601-1-1 (2003) Functional safety: ■ ISO 14971 ■ EN 60601-1-4 ■ EN 60601-1-4/A1 (2000) ■ EN 60601-2-16 Electromagnetic compatibility: ■ EN 60601-1-2 (2003) Disposables and Accessories Use only disposables and accessories approved by Medtronic for use with the Instrument. The use of other manufacturers' disposables and accessories has not been validated by Medtronic and will void the warranty on the Instrument and may jeopardize the functionality of the Instrument, possibly compromising patient safety. Used accessories and parts may be used with the Instrument only when their suitability for use has been established and certified, from the technical safety point of view, by a person or entity authorized by Medtronic to test their performance with the Instrument. Main Power Supply Failure In case of a main supply failure, fully-charged backup battery will allow treatment with a fully loaded system to continue for a minimum of 30 minutes (see page 5-44). 2-2 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_2.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Safety Electromagnetic Disturbance Electromagnetic Disturbance The Performer CPB has been designed and tested to comply with the requirements and tests of the electro-magnetic compatibility standard EN60601-1-2 (2003). It is advisable, however, to avoid its use in the presence of strong electromagnetic fields radiated from other equipment in the operating room (ie, defibrillators and electrocautery devices) that may cause interference. Special information regarding installation, use, and precautions are described in “Electromagnetic Emissions and Immunity Declarations” on page 3-6. The use of any accessory, probes, or cables other than those specified in this document, including replacement parts, may result in either increased emissions or decreased immunity of the Performer CPB. Elimination of the Disposable Material The disposables used in each treatment shall be disposed of using specific containers and in conformity with local norms. End of Life Disposition Do not dispose of this product in the unsorted municipal waste stream. Follow local regulations for proper disposal. Please refer to Medtronic web site http://recycling.medtronic.com for proper disposal guidance to ensure compliance with the European Union’s Waste Electrical and Electronic Equipment (WEEE) Directive. Calibration The calibration shall be performed only by authorized personnel. Technical Documentation The Service Manual, with electrical schemes, calibration procedures, and component lists, will be provided upon request, for exclusive use by authorized, trained personnel. Replacing Fuses No auto-restoring fuses are present on the Performer CPB equipment; only internal and external non-restoring fuses. The replacement of a malfunctioning internal fuse(s) must be performed by authorized, trained personnel. The replacement of a malfunctioning external fuse(s) must be performed by using the correct fuse(s) type as indicated by the external label and by the manufacturer (see “General Data” on page 3-2). Operator’s Manual A14113002 Rev. 2.0 2-3 PerformerV1.5_EN_2.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 2 Equipotential Connection Equipotential Connection Specific connection for the potential equalization is available on the Performer CPB in case the local regulations require “potential compensation” by means of connection to the potential compensation network. The potential equalization connection is also recommended if other pieces of equipment are used in combination with the Performer CPB. Battery Pack Disposal The life of the rechargeable battery packs is foreseen up to 4 years (depending on the number of charge/discharge cycles and on correct use). After this period, battery replacement and disposal is provided by authorized, trained personnel. 2-4 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_3.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Technical Specifications 3 3 General Data 3-2 Technical Features 3-3 Electromagnetic Emissions and Immunity Declarations 3-6 Monitoring System for Hematocrit, Temperature and O2 Saturation 3-10 Temperature Probes 3-11 Battery Supply System (UPS) 3-11 IEC 60601-2-16 Compliance Chart 3-12 Operator’s Manual A14113002 Rev. 2.0 3-1 PerformerV1.5_EN_3.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 3 General Data STATEMENT OF CONFORMITY AND CLASSIFICATION The equipment is a Class IIB active medical device in conformity with Annex IX of the European Council Directive MDD 93/42/EEC on Medical Devices. The equipment is CE marked according to the Annex 2.3 of the European Council Directive MDD 93/42/EEC on Medical Devices. General Data Electrical Data Classification (as for EN60601-1) Class I, type BF Operation Mode Continuous Voltage 100 to 240 VAC ± 10% Frequency 50 to 60 Hz ± 10% Current max. 6 A (100 to 120V) max. 3 A (220 to 240V) Power absorption max. 600 VA Earth leakage current < 300 µA Patient leakage current < 100 µA Potential equalization Connector available External fuses (type 5 x 20) 2x F6.3A/250V (100 to 120V) 2x F3.15A/250V (220 to 240V) Power Cord “Hospital Grade” type Max. 3 m length 10A, 125V (North America) 10A, 250V (Europe) Ingress Protection (IP code as for IEC 60529) IP 21: protected against solid foreign objects of 12 mm diameter and greater; protected against drop water. Environmental Operating Conditions Temperature +10°C to +40°C Relative humidity 30% to 75% (noncondensing) Atmospheric pressure 700 to 1060 mBar Transport and Storage Conditions Temperature -20°C to +60°C Relative humidity 10% to 90% (noncondensing) Atmospheric pressure 700 to 1060 mBar Interface 3-2 A14113002 Rev. 2.0 External Motor Drive (Bio-Pump) 10-pin LEMO®1 (EGG.3B.310.CLL) VARD Sensor 10-pin LEMO® (EGG.1B.310.CLL) Operator’s Manual PerformerV1.5_EN_3.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Technical Specifications Technical Features Flow Probe / ABD 15-pin D-SUB Level Sensors 7-pin LEMO® (EGG.1B.307.CLL) Auto Clamp 8-pin LEMO® (EGG.2B.308.CLL) Serial interface RS232 / RS485 (5 KV opto-isolated) 9-pin D-SUB Dimensions and Weight WxDxH 500 x 560 x 1000 - 1400 mm Weight Approximately 90 kg 1 LEMO® is a registered trademark of LEMO USA, Inc. Technical Features Pump PM1 Flows Unidirectional peristaltic pump with manual operating system ■ ■ ■ Up to 3.7 L/min (9.5 mm (3/8 in) pump segment) Up to 3.7 L/min (6.4 mm (1/4 in) and 6.4 mm (1/4 in) pump segments) Up to 1.8 L/min (6.4 mm (1/4 in) pump segment) Maximum tolerance ± 10% Pressure range within tolerance -150 to +500 mm Hg Protection system ■ ■ Pump PM2 Flows Feedback with rotation signal detected on the encoder. Open-cover sensor (and subsequent pump blockage). Unidirectional peristaltic pump with manual operating system ■ ■ ■ Up to 1.5 L/min (9.5 mm (3/8 in) pump segment) Up to 1.5 L/min (6.4 mm (1/4 in) and 6.4 mm (1/4 in) pump segments) Up to 0.8 L/min (6.4 mm (1/4 in) pump segment) Maximum tolerance ± 10% Pressure range within tolerance -150 to +500 mm Hg Protection system ■ ■ Pump PM3 Flows Feedback with rotation signal detected on the encoder. Open-cover sensor (and subsequent pump blockage). Unidirectional peristaltic pump with manual operating system ■ ■ Up to 0.6 L/min (6.4 mm (1/4 in) pump segment) Up to 0.16 L/min (3.2 mm (1/8 in) pump segment) Maximum tolerance ± 10% Pressure range within tolerance -150 to +500 mm Hg Operator’s Manual A14113002 Rev. 2.0 3-3 PerformerV1.5_EN_3.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 3 Technical Features Protection system ■ ■ Pump PM4 Flows Feedback with rotation signal detected on the encoder. Open-cover sensor (and subsequent pump blockage). Unidirectional peristaltic pump with manual operating system ■ ■ ■ Up to 1.1 L/min (6.4 mm (1/4 in) and 6.4 mm (1/4 in) pump segments) Up to 0.7 L/min (6.4 mm (1/4 in) and 3.2 mm (1/8 in) pump segments) Up to 0.6 L/min (6.4 mm (1/4 in) pump segment) Maximum tolerance ± 10% Pressure range within tolerance -150 to +500 mm Hg Protection system ■ ■ Feedback with rotation signal detected on the encoder. Open-cover sensor (and subsequent pump blockage). Pressures (PR1, PR2, PR3, PR4, PR7, PR8) Electronic measurement by means of sensors Operating range -500 to 500 mm Hg Maximum tolerance ± 5 mm Hg from -200 to 500 mm Hg ± 10 mm Hg from -500 to -200 mm Hg Protection system Test at time T1 (start-up self-tests) Pressures (VLP, ALP) Electronic measurement by means of sensors Operating range -500 to +750 mm Hg Maximum tolerance ± 5 mm Hg from -200 to 500 mm Hg ± 10 mm Hg from -500 to -200 mm Hg and from 500 to 750 mm Hg Protection system Test at time T1 (start-up self-tests) Note: The VLP and ALP pressure inputs have redundant protective pressure transducers. Flow Meter Ultrasonic transit-time type Tubing 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in) 6.4 mm (1/4 in) ID x 1.2 mm (1/16 in) (Not yet implemented.) Accuracy ± 10% (1.0 to 7.0 L/min) ± 20% (-0.15 to 1.0 L/min) Flow range 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in) ➝ 1.0 to 7.0 L/min 6.4 mm (1/4 in) ID x 1.2 mm (1/16 in) (Not yet implemented.) Air Bubble Detector (ABD) Sensitivity 3-4 A14113002 Rev. 2.0 Operator’s Manual Single bubble 0.1 mL (5000 Micron) to 0.3 mL of air at 7.0 L/min flow, 37°C, blood PerformerV1.5_EN_3.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Technical Specifications Technical Features Cardioplegia Air Sensors Ultrasound detection system Sensitivity 0.5 mL bubble volume at 500 mL/min Safety system Automatic: self-test performed every 10 minutes during the therapy Fluid-In-Line Sensors (FIL) Ultrasound detection system Sensitivity Able to detect presence of fluid in suction line UPS System Uninterruptable Power Supply Inlet voltage 24 V Outlet voltage 24 V Nominal current 6A Autonomy Minimum 30 min. (with fully loaded system - see page page 5-44) Buffer Battery Pack Type 2x12V - 9 A/h Recharging time 6 hours Replacement 4 years max. Buzzer Sound buzzer for alarms Type Uninterrupted sound Current 0.3 to 8.3 mA Sound level > 60 dB a 1 m Frequency 2500 Hz External Communication Interface Format Master-Slave Binary Communication Cable RS-485/USB Communication parameters: Baud Rate Bits Number Parity Stop Bit 57800 8 Null 1 Transmission Interval 1 second or greater Printer Fixed-head thermal printer Columns 52 … 104 (according to the character set) Printing speed 3.5 cm/sec Lines/sec 10 Character set extended ASCII Paper width 111.5 mm Power supply 24 V DC Consumption 3.5 A max Operator’s Manual A14113002 Rev. 2.0 3-5 PerformerV1.5_EN_3.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 3 Electromagnetic Emissions and Immunity Declarations Memory Card Type CompactFlash® with Personal Computer Memory Card International Association (PCMCIA) adapter Heater Not yet implemented. Weighing System Not yet implemented. Syringe Pump Not yet implemented. Reservoir Level Detection System (optional) Type Capacitive Reservoir Wall Thickness 1-3.5 mm (wall thickness for hard shell reservoir) Number of Sensors 2 AutoClamp System (optional) Type Pneumatic Clamp Force 14.5 Kg (32 lbs) Tubing 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in) PVC Air Pressure Required 379 - 689 kPa (55 - 100psi) Electromagnetic Emissions and Immunity Declarations Emissions Declaration The Performer CPB equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the Performer CPB equipment should ensure that it is used in such an environment. Table 3-1. Electromagnetic Emissions for all Equipment and Systems (Reference EN60601-1-2) Emission test Compliance Electromagnetic environment-guidance RF Emissions CISPR 11 Group 1 RF Emissions CISPR 11 Class A The Performer CPB equipment generates radio frequency (RF) energy only as a byproduct of its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuation / Complies flicker emissions IEC 61000-3-3 The Performer CPB equipment is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Immunity Declaration The Performer CPB equipment is intended for use in the electromagnetic environment specified in the following tables. The customer or the user of the Performer CPB equipment should ensure that it is used in such an environment. 3-6 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_3.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Technical Specifications Electromagnetic Emissions and Immunity Declarations Table 3-2. Electromagnetic Immunity for all Equipment and Systems (Reference EN60601-1-2) Immunity test IEC 60601 Test level Compliance level Electromagnetic environment-guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV in air Complies to the test level Floor should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity must be at least 30%. Electrical fast transient/ burst (ESD) IEC 61000-4-4 ±2 kV for power supply Complies to the test lines level ±1 kV for input/output lines Main power quality must be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1 kV differential mode Complies to the test ±2 kV common mode level Main power quality must be that of a typical commercial or hospital environment. Voltage dips, short interruption, and voltage variations on power supply input lines IEC 61000-4-11 <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycle 70% UT (30% dip in UT) for 25 cycle <5% UT (>95% dip in UT) for 5 sec Complies to the test level Main power quality must be that of a typical commercial or hospital environment. Note: In consideration of the possibility of continuous functional operation during main power interruption, the Performer CPB equipment is provided with an Uninterruptible Power Supply (UPS) with battery. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m Complies to the test level Power frequency (50/60 Hz) magnetic field must be at levels characteristic of a typical location in a typical commercial or hospital environment. Note: UT is the AC main voltage prior to application of the test level. Operator’s Manual A14113002 Rev. 2.0 3-7 PerformerV1.5_EN_3.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 3 Electromagnetic Emissions and Immunity Declarations Table 3-3. Electromagnetic Immunity for Life Supporting Equipment and Systems (Reference EN60601-1-2) Immunity test IEC 60601 Test level Compliance Electromagnetic level environment-guidance Follow the recommended separation distance calculated from the equation applicable to the frequency of the transmitter when using portable and mobile RF communication equipment in close proximity to any part of the Performer CPB equipment, including cables. Recommended separation distance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz Outside ISM bandsa 3Vrms d= 1,2√ P 10 Vrms 150 kHz to 80 MHz in ISM bandsa 6Vrms d= 2√ P 10 V/m 80 MHz to 2.5 GHz 10 V/m d= 1.2√ P 80 MHz to 800 MHz d= 2.3√ P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m)b. Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveyc, should be less than the compliance level in each frequency ranged. Interference may occur in the vicinity of equipment marked with the following symbol: 1. At 80 MHz and 800 MHz, the higher frequency range applies. 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. 3-8 A14113002 Rev. 2.0 a The ISM (Industrial, Scientific and Medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283; and 40.66 MHz to 40.70 MHz. b The compliance levels in the ISM frequency bands 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communication equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges. Operator’s Manual PerformerV1.5_EN_3.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Technical Specifications Electromagnetic Emissions and Immunity Declarations c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones, land mobile radios, amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Performer CPB equipment is used exceeds the applicable RF compliance level above, the Performer CPB equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Performer CPB equipment. d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and Performer CPB Equipment The Performer CPB equipment is intended for use in an electromagnetic environment in which radiated RF disturbance is controlled. The customer or user of the Performer CPB equipment can help prevent electromagnetic interference by distancing the portable and mobile RF communication equipment (transmitters) as far away as possible from the Performer CPB as recommended in Table 3-4, according to the maximum output power of the communication equipment. Table 3-4. Recommended separation distance between portable and mobile RF communication equipment and the Equipment or System for Life-Supporting Equipment and Systems (Reference EN60601-1-2) Rated maximum Separation distance according to frequency of transmitter output power of m transmitter 150 kHz to 80 80 MHz to 800 150 kHz to 80 800 MHz to 2.5 W MHz MHz outside ISM MHz in ISM GHz bands bands d= 1.2√ P d= 2.3√ P d= 2√ P d= 1.2√ P 0.01 0.12 0.20 0.12 0.23 0.1 0.38 0.63 0.38 0.73 1 1.2 2 1.2 2.3 10 3.8 6.3 3.8 7.3 100 12 20 12 23 For transmitters rated at the maximum output power not listed above, the recommended separation distance d in meters (m) can be determined by using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watt (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: The ISM (Industrial, Scientific and Medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283; and 40.66 MHz to 40.70 MHz. Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communication equipment could cause interference if it is inadvertently brought into patient areas. Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by adsorption and reflection from structures, objects, and people. Operator’s Manual A14113002 Rev. 2.0 3-9 PerformerV1.5_EN_3.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 3 Monitoring System for Hematocrit, Temperature and O2 Saturation Monitoring System for Hematocrit, Temperature and O2 Saturation The Performer CPB equipment has an integrated device, called the Hematocrit-Temperature-Saturation (HTS) Module, that allows the user to measure: ■ blood oxygen saturation in blood (Sat O2) ■ red blood cell concentration (hematocrit) in blood (Hct) ■ temperature of 8 external locations, detected by as many thermistor probes, connected with the device by means of a standard “jack” connection O2 Sat/Hct Caution: The oxygen saturation and hematocrit monitoring system is not intended to substitute for regular patient observation and laboratory testing. Prior to any therapeutic treatment, the oxygen saturation and hematocrit should be determined by laboratory methods. Warning: Do not connect the external temperature probes in conjunction with electrocautery. Warning: The device must be used only with thermistor temperature probes, as indicated by the manufacturer. Warning: The device has been designed in conformity with the IEC 60601-1-2 norm. It is advisable, however, to avoid its use in the presence of electromagnetic fields or other equipment causing interference (eg, cellular phones). Warning: In case of electromagnetic interferences, the temperature values detected by the external probes and indicated on the main display may undergo transitory variations. However, this is not an alarming condition for the patient since the temperature signals are not employed in the temperature control feedback. In the subsequent measurements, the user shall carefully evaluate the value(s) reliability in relation to the real conditions before proceeding with whatever action or control system modification. Electrical Data Voltage 5 VDC Current 0.2 A Patient's leakage current < 0.001 mA Performance 3-10 A14113002 Rev. 2.0 Sat O2 operating range 40 to 99% Sat O2 accuracy ± 4% (with In-Vivo Offset, see page 5-92) Hct operating range 15 to 50% Operator’s Manual PerformerV1.5_EN_3.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Technical Specifications Temperature Probes Hct accuracy ± 4% (with In-Vivo Offset, see page 5-92) Temperature Range +2°C to +45°C Temperature Accuracy ± 0.5°C Temperature Probes The manufacturer guarantees the proper functioning of the HTS device for the temperature measurement only when the following probe type is used (thermistor probe): Type Model Re-usable / Disposable YSI Series 400 Re-usable Warning: The utilization of other manufacturers' probes may jeopardize the performance of the device and, as a consequence, the measurement reliability. The performance and precision of the reusable probes indicated in the previous table will continue if the following recommendations are followed: High Temperature ■ ■ Do not expose the probe to temperatures higher than 100°C. Only expose the probes to temperatures in the range of 80°C and 100°C for short periods of time. Life Prolong the life of the cable by frequently sprinkling it with talcum powder, especially after disinfection. Mechanic Stresses Ensure that the cable is not subject to excessive mechanical stress like traction, squeezing, or kinking. Disinfection For proper disinfection of the multiple-use probes, refer to the instructions supplied by the manufacturer inside the packaging. Warning: A periodical maintenance/control of the multiple-use probes detecting efficacy is recommended every 3 months. Battery Supply System (UPS) The Performer CPB is equipped with a battery Uninterruptible Power Supply (UPS) system that provides the low voltage supply (24V) if the main power supply fails, thus allowing treatment to continue. Note: When the Uninterruptable Power Supply (UPS) converts the system to battery power, ALL pumps, pump functions, safety systems, alerts, alarms, monitors, controls, the Pinch Valve and the Central Information Display (CID) are active and function the same as when the system is on AC power. In case of a main supply failure, fully-charged battery backup will allow treatment with a fully loaded system to continue for a minimum of 30 minutes (see page 5-44.) Operator’s Manual A14113002 Rev. 2.0 3-11 PerformerV1.5_EN_3.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 3 IEC 60601-2-16 Compliance Chart Recharging of the battery pack is performed by means of a special circuit located in the base, therefore allowing the battery pack to get completely recharged when the equipment is turned on and is operated by the main power supply. It takes approximately 6 hours to completely recharge a fully depleted battery pack. IEC 60601-2-16 Compliance Chart REQUIREMENT 3-12 A14113002 Rev. 2.0 REFERENCE RESULT-REMARK 1. Description of the Installation Procedure See IFU page 4-2. 2. Syringe Pump Specification N/A; this device is not implemented at this time. 3. Blood Pump accuracy and specification; range, pressure accuracy See IFU page 3-3 to page 3-4. 4. Protective system description of the dialysis fluid composition (51.101) N/A; there is no dialysis fluid processing with this device. 5. Protective system description of the dialysis fluid temperature (51.102) N/A; there is no dialysis fluid processing with this device. 6. Protective system description of the ultra-filtration (51.103) N/A; there is no ultra-filtration processing system with this device. 7. Protective system description of the extracorporeal blood loss to the environment (51.104.1) N/A; the perfusionist is continually in view of the device during use. 8. Protective system description of the blood leak (51.104.2) N/A; the perfusionist is continually in view of the device during use. 9. Protective system description of the blood loss due to the coagulation (51.104.3) See IFU page 5-90. If the circulating hematocrit falls below 20%, the Protective System activates distinct audible and visual cues to warn the user. In case the blood pump stops during Perfusion Mode or in case the blood pump is stopped inadvertently, after 60 seconds the Protective System activates distinct audible and visual alarms. Operator’s Manual PerformerV1.5_EN_3.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Technical Specifications IEC 60601-2-16 Compliance Chart 10. Protective system description of the Arterial Pressure (51.105) See IFU page 5-84. When the arterial pressure alert limit is exceeded, the Protective System activates distinct audible and visual cues to warn the user. When the arterial pressure alarm limit is exceeded, the Protective System activates distinct audible and visual cues to warn the user and immediately stops the blood pump. 11. Protective system description and sensitivity of the Air Infusion prevention (51.106) For the system description, see IFU page 5-63. For the system sensitivity, see IFU page page 3-4. When air is detected by an Air Bubble Detector (ABD), the Protective System activates distinct audible and visual alarm cues to warn the user and immediately stops the blood pump. 12. Protective system description of the Buffer-free HDF (51.111) N/A; there is no Buffer-free HDF preparation with this device. 13. Over-ride time of the Protective System (51.108) See IFU page 7-2. An over-ride of the Protective System will activate continuous visual and audible “alert” cues. See IFU page 5-66. The audible alarm cue can be temporarily muted. If the Protective System is not corrected and reset within one minute, the audible alarm cue will automatically resume. 14. Audible alarm time period (51.107) See IFU page 5-66. The audible alarm cue can be temporarily muted. If the Protective System is not corrected and reset within one minute, the audible alarm cue will automatically resume. 15. Sound pressure level of audible alarm source. (51.107) See IFU page 5-30. Except for the VARD Alarm, the sound level (volume) for alarms is not settable. 16. Contact material with dialysis fluid (51.107) N/A; there is no dialysis fluid processing with this device. Operator’s Manual A14113002 Rev. 2.0 3-13 PerformerV1.5_EN_3.fm 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 3 IEC 60601-2-16 Compliance Chart 3-14 A14113002 Rev. 2.0 Operator’s Manual Medtronic Confidential CS0023 PerformerV1.5_EN_4.fm 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Medtronic Confidential CS017 Installation 4 Installation 4 4-2 Installation Checklist and Commissioning 4-3 Operator’s Manual A14113002 Rev. 2.0 4-1 PerformerV1.5_EN_4.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 4 Installation Installation All installation and verification procedures shall be performed in the presence of authorized, service personnel. Installation ■ After unpacking the equipment, verify its integrity and the presence of the necessary accessories. ■ Do not install the equipment near areas at risk of explosion or where flammable anaesthetic gases are used. ■ Do not turn on the equipment if any physical anomalies are noticed that could jeopardize the correct functioning of the equipment. Contact a Medtronic service technician. ■ Do not use adapters or extension cords on the main power cable. If necessary, replace the equipment plug with one that is consistent with the available power supply system. Grounding ■ Since the Performer CPB is a Class I device per IEC 60601-1 (Clause 14), it must be connected to a properly grounded power source. ■ The grounding reliability of the power source must be accomplished in accordance with the effective local regulation and the IEC 60601-1 harmonized standard (Clauses 18, 58: Protective earthing, functional earthing and potential equalization). ■ The hospital/clinic’s electrical environment department should be contacted for any clarification or questions. Potential Equalization Line If other pieces of equipment are present, the use of the specific connection for the potential equalization is recommended. Power Supply The equipment must be operated from the type of power indicated on the identification data label. ■ Voltage AC 100/240 ■ Frequency 50/60 Hz Liquid/Foreign Matter Penetration The equipment is protected from liquid/foreign matter penetration according to the IEC 60529 standard definition: protection class of the Performer CPB is IP 21. Turning On Operate the equipment only when it has reached room temperature. Intended use The Performer CPB equipment is intended exclusively for hospital use. The Performer CPB equipment is NOT for domestic use. 4-2 A14113002 Operator’s Manual Rev. 2.0 PerformerV1.5_EN_4.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Installation Installation Checklist and Commissioning Installation Checklist and Commissioning VISUAL INSPECTION Integrity of external components; check for damages due to transport Identification data label, stickers, warning labels Main Power Supply voltage, plug model, cable and fair-leads Movement of rotating parts Accessories and documentation FUNCTIONAL INSPECTION Height regulation device Braking device Central Information Display ■ Configuration Mode ■ Touch Screen alignment ■ Perfusion Mode Bio-Pump Control Panel and Display Roller Pump Control Panels and Displays Pressure Sensors ■ PR1, PR2, PR3, PR4, VLP, ALP, PR7, PR8 ■ Test Measurement at 0 mm Hg ■ Test Measurement at +450 mm Hg ■ Test Measurement at -450 mm Hg HTS Module ■ Temperature ■ O2 Sat / Hematocrit Bio-Pump Flow Probe / Air Bubble Detector VARD Ultrasonic Sensors Cardioplegia Air Bubble Detector FIL Sensor Roller Pumps AAR Solenoid Pinch-Valve Printer Battery Pack charge level and UPS AutoClamp System (optional) Reservoir Level Detection System (optional) System Mode Simulation Operator’s Manual A14113002 Rev. 2.0 4-3 PerformerV1.5_EN_4.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 4 Installation Checklist and Commissioning ELECTRICAL SAFETY CHECK PER IEC EN 60601-1 REGULATIONS Protective earth resistance Earth leakage current NC Housing leakage current NC Leakage current with main voltage on A.P. Patient leakage current (A.P.) NC 4-4 A14113002 Operator’s Manual Rev. 2.0 PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use 5 Console 5 5-2 Roller Pump, Roller Inserts, Tube Inserts, and Tubing 5-6 System Configuration 5-16 System Start-up 5-35 Main Run Screen 5-41 Timers 5-46 Cardioplegia 5-49 AAR Controller - Venous Air Removal Device (Resting Heart mode only) 5-58 Air Detection 5-63 Level Sensing System (Bio-Pump CPB mode only) 5-67 AutoClamp System (Bio-Pump CPB mode only) 5-73 Pressure Mode Selection 5-84 Venous Saturation and Hematocrit Monitoring Options Menu Screen 5-90 5-94 Servo (Resting Heart mode only) 5-104 Preparing for Cardiopulmonary Bypass Checklist Initiating Extracorporeal Support Checklist 5-109 5-112 Operator’s Manual A14113002 Rev. 2.0 5-1 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Console Console External Operational Controls 4 5 6 3 2 7 1 Figure 5-1. Performer CPB Controls 1. Power Cord: Connects the system to the appropriate wall electrical (AC) power supply. 2. Fuse/Circuit Breakers: For service personnel use only. The replacement of a malfunctioning external fuse(s) must be performed by using the correct fuse(s) type indicated by the external label and by the manufacturer (see “General Data” on page page 3-2). 3. Grounding Equalization Post: When local regulations require “potential compensation,” connect a cable from the potential compensation network to this grounding equalization post. 4. Main Power Switch: Press the top of the Main Power switch to turn the system on. The displays next to the pump controls will illuminate and an audible start-up tone will sound. To turn off AC power, press the bottom of the Main Power switch. 5. Console Up and Down Switches: Press and release the Up switch to elevate the console on its pedestal to the maximum “up” limit. Press and release the Down switch to lower the console on its pedestal to the maximum “down” limit. The user may stop console up or down movement at any time by pressing and releasing the respective Up or Down switch once the desired height is reached. Note: The press-and-release function of the console Up/Down switches are disabled after leaving the Home Screen and entering an operational mode (Resting Heart or Bio-Pump CPB). To adjust the height while in an operational mode, the user must press and hold the respective Up or Down switch until the desired height is reached. 6. Castor Brake and Unbrake Switches: The console is mounted on 4 castors. The two rear castors are in permanent front-to-back alignment, but the two front castors swivel 360 degrees. Press the Castor Brake switch to prevent the console from rolling. Press the Castor Unbrake switch to release the brakes and enable movement of the console. 5-2 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Console 7. Batteries: Integrated batteries provide uninterruptible battery backup for the entire system in the event wall power is lost. Fully-charged batteries will power the system for a minimum of 30 minutes with a fully loaded system (see page 5-44). Front Panel - Controls and Displays 1 2 6 3 7 8 9 4 10 11 5 12 Figure 5-2. Console Front Panel 1. CID (Closed): Incorporates graphic menus and buttons for the user-selectable options, provides enabling or disabling of components and safety devices, provides visual and audible signals during alert and alarm conditions, monitors system functions during use, and displays information pertinent to patient physiology during extracorporeal procedures. 2. Bio-Pump Control Panel with Backup Displays: Incorporates a pump speed RPM knob, LED flow display, and two backup LCD displays. (See Figure 5-4.) 3. Roller Pump Control Panel and Display for PM1: Incorporates a Start/Stop button to enable/disable the pump motor, a 3-turn potentiometer knob to control RPM, an LCD to indicate motor on/off status, pump flow, or RPM information, and pump identification information. 4. Large Roller Pump PM1: Configured for suction or left heart venting. Maximum flow capacity is 3.7 L/min. Accommodates the following tube sizes: ■ 6.4 mm (1/4 in) x 1.2 mm (1/16 in) ■ 6.4 mm (1/4 in) x 1.2 mm (1/16 in) and 6.4 mm (1/4 in) x 1.2 mm (1/16 in) (Two tubes) 9.5 mm (3/8 in) x 2.4 mm (3/32 in) (PVC) 5. External Communication Interface: RS-485/USB port to connect the Performer CPB to a perfusion data collection system. ■ Operator’s Manual A14113002 Rev. 2.0 5-3 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Console 6. Small Roller Pump PM4: Configured for delivery of cardioplegia. Maximum flow capacity is 1.1 L/min. Accommodates the following tube sizes: ■ 6.4 mm (1/4 in) x 1.2 mm (1/16 in) and 6.4 mm (1/4 in) x 1.2 mm (1/16 in) (Two tubes) ■ 6.4 mm (1/4 in) x 1.2 mm (1/16 in) and 3.2 mm (1/8 in) x 1.2 mm (1/16 in) (4:1 Cardioplegia) 6.4 mm (1/4 in) x 1.2 mm (1/16 in) 7. Roller Pump Control and Display for PM4: Incorporates a Start/Stop button to enable/disable the pump motor, a 3-turn potentiometer knob to control RPM, an LCD display to indicate motor on/off status, pump flow, or RPM information, and pump identification information. 8. Small Roller Pump PM3: Configured to be used either as a cardioplegia slave pump in conjunction with PM4, or as a free pump (examples: hemoconcentrator, aortic root vent). Maximum flow capacity is 0.6 L/min. Accommodates the following tube sizes: ■ ■ 6.4 mm (1/4 in) x 1.2 mm (1/16 in) 3.2 mm (1/8 in) x 1.2 mm (1/16 in) 9. Roller Pump Control and Display for PM3: Incorporates a Start/Stop button to enable/disable the pump motor, a 3-turn potentiometer knob to control RPM, an LCD to indicate motor on/off status, pump flow, or RPM information, and pump identification information. 10. Large Roller Pump PM2: Configured for suction or left heart venting. Maximum flow capacity is 1.5 L/min. Accommodates the following tube sizes: ■ ■ 6.4 mm (1/4 in) x 1.2 mm (1/16 in) ■ 6.4 mm (1/4 in) x 1.2 mm (1/16 in) and 6.4 mm (1/4 in) x 1.2 mm (1/16 in) (Two tubes) 9.5 mm (3/8 in) x 2.4 mm (3/32 in) (PVC) 11. Roller Pump Control and Display for PM2: Incorporates a Start/Stop button to enable/disable the pump motor, a 3-turn potentiometer knob to control RPM, an LCD to indicate motor on/off status, pump flow, or RPM information, and pump identification information. 12. PR1 Pressure Transducer Port: Connects to a pressure monitoring line with fluid isolator when pressure-limiting safety responses are required with roller pump PM1. ■ System Status LEDs (Green, Yellow, and Red) At the top of the CID, but outside the touch screen, are three colored lights that are associated with the operation status of the system. These lights serve as an additional visual cue for the user when a change in an alarm, alert, or system status occurs. 2 1 3 Figure 5-3. System Status LEDs 5-4 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Console 1. When the green lights are illuminated, all safety devices are engaged and all systems are functioning normally. 2. When the yellow lights are illuminated, there is either a system status change, a safety device is not engaged, or the Alert Mode of a safety device is activated. 3. When the red lights are illuminated, the Alarm Mode of a safety device is activated. Bio-Pump Control Panel 4 3 1 2 Figure 5-4. Bio-Pump Control Panel 1. Pump Speed RPM Knob ■ Turn the knob clockwise to control the external drive motor speed from 0 to approximately 4500 RPM. ■ Completely rotate the knob counterclockwise to below 0 RPM and “click” to turn the drive motor off. ■ The knob provides for a minimum RPM detent button. This is a mechanical stop that prevents an unintentional reduction of RPM below 2000. Press down on the detent lever while turning the knob counterclockwise to reduce the RPM below 2000. The minimum RPM detent button does not affect increasing the RPM. 2. Flow Display ■ ■ Displays the Bio-Pump flow rate in liters per minute (L/min). This is an additional display for the Bio-Pump flow value that is also shown on the Main Run Screen of the CID. ■ The LED will display flow from 0.00 to 9.99 L/min. Note: In the event the CID fails, the front panel Bio-Pump flow display will continue to function and display blood flow detected by the ultrasonic blood flow transducer. 3. Backup LCDs ■ Two LCDs display 6 user-selected hemodynamic or metabolic parameters. ■ The LCDs provide additional displays of essential parameters viewed on the CID. Note: In the event the CID fails, the LCDs will continue to function and enable selection and display of the listed parameters. (See “Emergency Procedures” on page 7-4.) 4. Scroll Arrows Operator’s Manual A14113002 Rev. 2.0 5-5 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Roller Pump, Roller Inserts, Tube Inserts, and Tubing The scroll arrows allow selection/viewing of the following parameters in each of the backup LCDs (only in the Emergency Mode): ■ Revolutions Per Minute (RPM) ■ Arterial Line Pressure (ALP) ■ Venous Line Pressure (VLP) (Resting Heart mode only) ■ Cardioplegia Pressure (CPG) ■ Venous Oxygen Saturation (SO2) ■ Hematocrit (Hct) Roller Pump, Roller Inserts, Tube Inserts, and Tubing Roller Pumps Roller pumps are indicated for moving fluids through a flexible tube. As each roller passes through the pump raceway, it occludes the tube and displaces the fluid in the tube in the direction of rotation. Each pump only rotates in a clockwise direction. Uses include, but are not limited to, propulsion of arterial blood and myocardial preservation solutions, and extraction of fluids from the thorax or vascular chambers. The Performer CPB comes with two (2) large roller pumps with a maximum flow potential of 3.7 L/min (PM1) or 1.5 L/min (PM2) and two (2) small roller pumps with a maximum flow capacity of 1.1 L/min (PM4) or 0.64 L/min (PM3). 3 4 5 6 7 2 1 8 Figure 5-5. Roller Pump Components 1. 2. 3. 4. 5. 6. 7. 8. 5-6 A14113002 Rev. 2.0 Operator’s Manual 3-Turn Roller Speed Control Knob Start/Stop Button Pump Label and Units of Measure for the Digital Display for flow or RPM Digital Display for flow or RPM Calibrated Roller Insert Pump Safety Cover Pump Safety Cover Interlock Sensor Pump Raceway PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Roller Pump, Roller Inserts, Tube Inserts, and Tubing Roller Insert 3 1 2 3 Figure 5-6. The Calibrated Roller Insert 1. Integrated Handcrank 2. Closed Handcrank Locking Channel 3. Tubing Guides Installing the Roller Insert To install the roller insert: 1. Place the pump in the Stop Mode and lift the pump safety cover. 2. Unlatch and lift the integrated handcrank on the roller insert. 3. Slide the roller insert over the motor drive shaft so the alignment pin in the center of the roller insert matches the groove in the motor drive shaft. 4. Rotate the roller insert until the close/locking channel for the integrated handcrank aligns with the channel in the end of the motor drive shaft. 5. Latch the integrated handcrank into the close/locking channel. 6. Close the pump safety cover. Removing the Roller Insert 1. 2. 3. 4. Place the pump in the Stop Mode and lift the pump safety cover. Ensure the tubing is removed from the pump. Unlatch and lift the integrated handcrank on the roller insert. Slowly rotate the roller insert while applying slight outward traction until the alignment pin “finds” the groove in the motor drive shaft. 5. Slide the roller insert out to remove. Setting the Roller Pump Speed 1. A flashing digital display indicates the pump Start/Stop button is in the Stop Mode. Turn the roller speed control knob completely counterclockwise. Ensure that the digital display is flashing “0.” 2. Press the Start/Stop button to activate the pump. The digital display will stop flashing. Operator’s Manual A14113002 Rev. 2.0 5-7 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Roller Pump, Roller Inserts, Tube Inserts, and Tubing 3. Turn the roller speed control knob to set the pump speed. Clockwise rotation increases RPM; counterclockwise rotation decreases RPM. The full turning range of each control knob is three turns. 4. As the pump speed changes, the digital display will reflect the parameter of either the pump RPM or the flow rate in milliliters per minute (mL/min) or liters per minute (L/min), indicated on the pump label. 5. To stop the pump, press the Start/Stop button. The digital display will flash. 6. After the pump is stopped, ensure that the roller speed control knob is rotated completely counterclockwise and the digital display is flashing “0.” 7. To change the pump label, refer to the “System Configuration” section on page 5-16. Manual Operation with the Integrated Handcrank Warning: If handcrank operation is necessary due to the loss of AC and battery power, flow detection and safety systems are inoperable. Closely monitor the circuit to prevent introduction of air. Note: The rollers in the roller inserts are installed with one-way bearings to prevent inadvertent reverse handcranking. When tubing in installed in the pump raceway, the rotation of the pump will only occur in a clockwise direction. 1. Ensure that the pump is in the Stop Mode and lift the pump safety cover. 2. Unlatch the integrated handcrank. 3. Slide the handcrank extension over the small black knob. 4. Grasp the large black knob on the handcrank extension and rotate the pump clockwise. 5-8 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Roller Pump, Roller Inserts, Tube Inserts, and Tubing Tube Inserts Installing the Tube Inserts To install the tube inserts: 1. Place the pump in the Stop Mode and lift the pump safety cover. 2. Remove the faceplate thumbscrew. 3. Slide the faceplate outward along the dovetail joint and remove. Operator’s Manual A14113002 Rev. 2.0 5-9 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Roller Pump, Roller Inserts, Tube Inserts, and Tubing 4. Place the appropriate size tube insert into the slide channel. Note the location of the hinge. 5. Replace the front faceplate to the pump housing and slide inward along the dovetail joint. 6. Replace the faceplate thumbscrew and close the cover. 5-10 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Roller Pump, Roller Inserts, Tube Inserts, and Tubing Tubing Loading the Tubing To load the tubing: 1. Place the pump in the Stop Mode. Ensure that the appropriate roller insert for the tubing size being used is properly installed. Ensure the appropriate tube inserts are installed for the tubing size(s) being used. Warning: Always ensure proper direction of rotation before installing tubing into the roller pump and that the direction of forward flow for the tubing is consistent with the rotational direction of the roller pump. Always ensure that the direction of flow is NOT in a retrograde direction that would result in pumping air into the patient. 2. Lift and open the tube inserts. 3. Open the cover and unlatch the handcrank. Rotate the roller insert clockwise to optimize space in the pump raceway to accommodate the tubing. 4. Align the tubing along the arc of the pump raceway while placing the tubing into the tube inserts. Operator’s Manual A14113002 Rev. 2.0 5-11 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Roller Pump, Roller Inserts, Tube Inserts, and Tubing 5. Close and then press the inlet tube insert into its channel guide. 6. Feed the tubing between the guide rollers and along the arc of the pump raceway while rotating the roller insert by hand. 7. Close and press the outlet tube insert into its channel guide. Ensure that the tubing is held securely in the tube inserts by pulling it lightly. Inspect the tubing in the pump raceway so it is not twisted and fits evenly. 8. Latch the handcrank into the locking channel of the motor drive shaft. 5-12 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Roller Pump, Roller Inserts, Tube Inserts, and Tubing 9. Close the pump safety cover. Loading the Tubing (Mechanical Loading Feature) 1. Lift the roller cover and slide out the tube inserts. 2. Open the tube inserts. 3. Lay the tubing along the circumference of the pump housing to estimate the length of the tubing to place in the pump raceway. 4. Secure the tubing into the tube insert at the pump inlet. Close the insert and press into the channel guide. 5. Secure the tubing in the tube insert at the pump outlet. Close the insert, but do not press into the channel guide. 6. Close the pump safety cover as much as it will allow. 7. Press in the Options Menu Screen. 8. Press in the Roller Pump Configuration Screen until the red indicator on the console graphic corresponds with the roller pump that is being loaded with tubing. 9. Press the gray Tube Loading button . When it changes color, press and hold the roller pump Start/Stop button. The roller pump will slowly turn and load the tubing into the pump raceway. When the tubing is loaded, release the pump Start/Stop button to stop the roller pump from turning. Note: The Tube Loading button will only stay active for 10 seconds each time it is pressed. The top line of the message bar will display “LOADING/UNLOADING PM1 PUMP SEGMENT.” 10. Press the tube insert at the pump outlet into the channel guide. 11. Ensure the pump safety cover is closed. Operator’s Manual A14113002 Rev. 2.0 5-13 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Roller Pump, Roller Inserts, Tube Inserts, and Tubing Connections for Peripheral Components 8 7 6 9 5 4 3 10 2 11 1 Figure 5-7. Peripheral Connections 1. AAR FIL Sensor: Detects the presence of air or fluid when used in conjunction with the VARD purge line. [Resting Heart mode only] 2. PR2 Pressure Transducer Port: Connects to a pressure monitoring line with a fluid isolator when pressure-limiting safety responses are required with roller pump PM2. 3. For the Bio-Pump CPB mode, this port is designated the PR7 Pressure Transducer Port. It connects to a pressure line with fluid isolator and enables the use of optional pressure-limiting safety responses. For the Resting Heart mode, this port is the AAR Vacuum Pressure Sensor. It connects to the vacuum pressure line with a fluid filter on the VARD suction tube. 4. Cardioplegia Air Sensor: Detects macro-air in the 6.4 mm (1/4 in) x 1.2 mm (1/16 in) line between the cardioplegia pump (PM4) and the cardioplegia heat exchanger and air bubble trap. 5. PR3 Pressure Transducer Port: Connects to a pressure monitoring line with a fluid isolator when pressure-limiting safety responses are required with roller pump PM3. 6. For the Bio-Pump CPB mode, this port is designated the PR5 Pressure Transducer Port. It connects to a pressure line with fluid isolator and enables the use of optional pressure-limiting safety responses. For the Resting Heart mode, this port is labeled the Venous Line Pressure (VLP) Sensor. It is used to monitor the Venous Line Pressure and enables configuring Bio-Pump responses if conditions occur that exceed user-defined negative pressure limits. 7. Arterial Line Pressure (ALP) Sensor (PR6): Connects to a pressure monitoring line with a fluid isolator from the arterial circuit when Bio-Pump responses are required if conditions occur that exceed user-defined positive pressure safety limits. 8. PR4 Pressure Transducer Port: Connects to a pressure monitoring line with a fluid isolator when pressure-limiting safety responses are required with the cardioplegia roller pump (PM4). 9. Multi-purpose Mounting Flange(s): Attaches to pole supports for mounting hardware and brackets. 5-14 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Roller Pump, Roller Inserts, Tube Inserts, and Tubing 10. AAR Pinch Valve: Opens and closes on the suction tube between the VARD and a rigid suction canister. [Resting Heart mode only] 11. External Devices Connector Panel: Connection site for external devices. 3 2 1 4 5 Figure 5-8. External Devices Connector Panel 1. Connection site for the ultrasonic flow sensor with Air Bubble Detector. 2. Connection site for the Bio-Pump External Drive Motor. Warning: Only use a Bio-Pump External Drive Motor with a cable that does not exceed 120 cm in length. 3. Connection site for the VARD cable. 4. Connection site for the Level Sensor Cable. 5. Connection site for the AutoClamp System Interface Cable. CompactFlash® Memory Card with PCMCIA Adapter Installation The CompactFlash® memory card is used to perform software upgrades with the Performer CPB and to store perfusion data following a case. Note: Use only Medtronic approved CompactFlash® memory cards. The slot to install the CompactFlash® memory card is next to the printer. Note: Before installing the card and adapter into the Performer CPB, ensure the system power is off. 1. To insert the CompactFlash® memory card into the PCMCIA adapter, orient the CompactFlash® memory card so that the slot/groove on the edge of the card aligns with the slot/groove on the PCMCIA adapter. 2. Slide the card fully into place until the pin protector is fully depressed and the card “clicks” into place. 3. Open the printer access panel. Operator’s Manual A14113002 Rev. 2.0 5-15 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 System Configuration 4. Orient the label side of the CompactFlash® memory card towards the front of the console. 5. Depress the PCMCIA adapter fully into the slot. The release button next to the card will protrude upward when the adapter is fully seated in the slot. 6. To remove the PCMCIA adapter, depress the release button. Note: To download data, the CID must be in the Home Screen. Warning: After the CID is changed to the Home Screen, the screen will display an hourglass icon for approximately 10 seconds, indicating data download to the CompactFlash® memory card. The red LED next to the PCMCIA slot also indicates data download. DO NOT remove the PCMCIA adapter until the hourglass has cleared and the red LED goes off. System Configuration System Configuration is a user-defined programming process that is necessary to ensure that the safety systems and pump functions of the Performer CPB conform to the conduct of perfusion protocols specific to how either the Resting Heart mode and the Bio-Pump CPB mode will be used at the institution. It is typically a one-time setup procedure performed by a Perfusionist designated as the System Administrator. It is recommended this process be completed before the Performer CPB is used for a surgical bypass procedure. Each Performer CPB comes pre-programmed with factory default settings for the Resting Heart mode and Bio-Pump CPB mode. When these settings are modified by the System Administrator during the process of System Configuration, these new settings can be saved as a new profile and can be password protected by the System Administrator (see “Password Protection” on page 5-18). Preparation for Use To begin using the Performer CPB, plug the console into an appropriate AC power outlet, lift the CID, and turn on the Main Power switch. The CID will display “SYSTEM INITIALIZATION” for several seconds, followed by the Power On Self-Test (POST) screen (see Figure 5-9). 5-16 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use System Configuration Power On Self-Test Figure 5-9. Power On Self-Test Screen Warning: Ensure the roller pump safety covers remain closed during the POST. Warning: Ensure that all pressure transducer ports are open to atmosphere during the POST. Warning: When running the Resting Heart mode, ensure there is no tubing in the pinch valve for the AAR Controller. During the POST, the system will cycle through the following four test procedures: ■ Pressure Calibration: Confirms that the pressure transducer channels zero properly. ■ Relay 24: Confirms the proper operation of the 24-volt relay. ■ Roller Pumps: Confirms the proper operation of the four roller pumps. During this test, the roller pumps will rotate for several seconds and then automatically stop. ■ VARD Pinch Valve: Confirms the pinch valve opens and closes properly. (Resting Heart mode only) Following each test cycle, the POST screen will indicate whether the system PASSED (green checkmark) or FAILED (red X) the test. If all tests have PASSED, the screen will automatically proceed to the Home Screen. If any test fails: ■ a red X will indicate the affected system ■ three alarm tones will sound ■ the system status LED will change to red ■ the message bar will change to red ■ the message bar will display “SELF-TEST FAILED” To repeat the POST due to a FAILED test, press the Repeat Self-Test button in the upper-right corner of the screen . When the Repeat Self-Test button is pressed, the following will occur: ■ the system status LED changes to yellow ■ the message bar changes to blue ■ the message bar reads “POWER ON SELF-TEST RUNNING” Warning: If the POST repeatedly produces a FAILED indication, contact a Medtronic service representative. To skip the POST, press in the upper-right corner of the CID. Operator’s Manual A14113002 Rev. 2.0 5-17 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 System Configuration Warning: Bypassing the POST at any time may cause error messages or malfunction during use. A window will appear asking, “Do you really want to skip power on self-tests?” Press the green checkmark to bypass the POST and proceed to the Home Screen. PASSED Self-Test When all the self-test functions indicate PASSED, the CID will automatically proceed to the Home Screen. Password Protection 2 3 1 Figure 5-10. Configuration Mode Password Protection 1. Ensure the Home Screen displays the proper Perfusion Mode (Resting Heart or Bio-Pump CPB). 2. Press “SYSTEM CONFIGURATION” to enter the Configuration Mode. A five-digit password must be entered to begin use of the Configuration Mode. 3. As the password numbers are entered using the numeric buttons, the system will place an asterisk in the box and the cursor will automatically advance to the next box. Once the correct password is entered, the screen will automatically revert to the User Profiles screen of the Configuration Mode. 4. Press to revert back to the Home Screen. Note: To configure a new system administrator password, See “Password Configuration” on page 5-31. Configuration Mode Screens Access to the numerous Configuration Mode screens is achieved through the Menu Bar. 5-18 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use System Configuration 4 3 2 5 1 Figure 5-11. Configuration Mode Screen Functional Areas 1. 2. 3. 4. 5. Menu Bar Alpha-Numeric Keyboard Display Area (Corresponds to what was selected in the Menu Bar.) Components List with Scroll Arrows Press to display special and language-specific characters in the numeric row of the keyboard. Menu Bar The menu bar includes static function buttons used to select the components or systems for configuration. When a button is pressed, the functional category will appear in the configuration list area and configuration buttons will appear in the display area. 1 2 3 4 5 6 7 8 Figure 5-12. Menu Bar Options 1. 2. 3. 4. 5. 6. 7. 8. Return to the Home Screen User Profiles Configuration Roller Pumps Configuration Pressure Transducers Configuration Temperature Channels Configuration Safety Systems Configuration User Preferences Configuration Service Configuration Operator’s Manual A14113002 Rev. 2.0 5-19 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 System Configuration Configuration of the Roller Pumps, Pressure Transducers, and Temperature Channels 2 7 6 3 4 1 Figure 5-13. Component Configurations To configure the Roller Pumps: 1. 2. 3. 4. Press on the menu bar. Use the left/right scroll arrows to select the roller pump to be configured. Press the lavender button under NAME. Type the new name using the keyboard. As the letters are entered, the new name will appear in the highlighted button. 5. Save the new name by pressing the button with the new name. Names for the roller pumps appear in their respective LCD display on the front of the console, on the Roller Pump Setup Screen, in the Safety Systems Configuration screens, and on the On-Bypass Parameters View Screen. 6. Press the lavender button under UNITS to select from the options of L/MIN, ML/MIN, or RPM. 7. Press the lavender button under TUBE to select from the options for the ID of the tube size(s) to be used (applicable only to roller pumps PM1 and PM2). ■ To configure the Pressure Transducers: 1. 2. 3. 4. Press on the menu bar. Use the left/right scroll arrows to select the pressure channel to be configured. Press the lavender button under NAME. Type the new name using the keyboard. As the letters are entered, the new name will appear in the highlighted button. 5. Save the new name by pressing the button with the new name. Names for the pressure channels appear on the On-Bypass Parameters View Screen and in the blue Message Bar. 6. Press the lavender button under ALERT LIMIT or the ALARM LIMIT. ■ 5-20 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use System Configuration 7. Type the new pressure limit value using the keyboard. The system will accept either positive or negative values. Press the edited value in the button to save. If the new value is not saved, the window will revert back to the old value. To configure the Temperature Channels: 1. Press on the menu bar. 2. Use the left/right scroll arrows to select the temperature channel to be configured. 3. Press the lavender button under NAME. 4. Type the new name using the keyboard. As the letters are entered, the new name will appear in the highlighted button. 5. Save the new name by pressing the button with the new name. ■ Names for the temperature channels appear on the On-Bypass Parameters View Screen and in the blue Message Bar. Configuration of the Safety Systems The Performer CPB comes pre-configured with factory default settings for pump responses to Safety System events. Review of these default settings is the responsibility of the System Administrator to ensure whether they conform to the conduct of the applicable perfusion protocols or whether settings need to be changed. Table 5-1. Default Pump Responses specific to Resting Heart Mode EVENT BIO-PUMP PM-1 PM-2 PM-3 PM-4 Air in VARD MESSAGE ONLY NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Too Much Air in VARD COAST NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Overpressure Alert: VLP MESSAGE ONLY NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Overpressure Alarm: VLP COAST NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Overpressure Alert: VARD MESSAGE ONLY NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Overpressure Alarm: VARD MESSAGE ONLY NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Operator’s Manual A14113002 Rev. 2.0 5-21 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 System Configuration Table 5-2. Default Pump Responses specific to Bio-Pump CPB Mode EVENT BIO-PUMP PM-1 PM-2 PM-3 PM-4 Low Blood Level Alert COAST NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Low Blood Level Alarm STOP NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Overpressure Alert: PR5 MESSAGE NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Overpressure Alarm: PR5 MESSAGE NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Overpressure Alert: PR7 MESSAGE NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Overpressure Alarm: PR7 MESSAGE NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Table 5-3. Default Pump Responses Common to both Resting Heart and Bio-Pump CPB Modes EVENT 5-22 A14113002 Rev. 2.0 BIO-PUMP PM-1 PM-2 PM-3 PM-4 Air Detected by ABD STOP STOP STOP STOP STOP Air in Cardioplegia Circuit NO RESPONSE STOP STOP STOP STOP Bio-Pump Stop NO RESPONSE STOP STOP STOP STOP Bio-Pump Coast NO RESPONSE STOP STOP STOP STOP Bio-Pump Backflow MESSAGE ONLY NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Bio-Pump Low Flow MESSAGE ONLY NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Bio-Pump High Flow MESSAGE ONLY NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Overpressure Alert: ALP MESSAGE ONLY NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Overpressure Alarm: ALP COAST NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Overpressure Alert: PR1 NO RESPONSE MESSAGE ONLY NO RESPONSE NO RESPONSE NO RESPONSE Overpressure Alarm:PR1 NO RESPONSE PAUSE NO RESPONSE NO RESPONSE NO RESPONSE Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use System Configuration EVENT BIO-PUMP PM-1 Overpressure Alert: PR2 NO RESPONSE NO RESPONSE Overpressure Alarm: PR2 NO RESPONSE Overpressure Alert: PR3 PM-2 PM-3 PM-4 MESSAGE ONLY NO RESPONSE NO RESPONSE NO RESPONSE PAUSE NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE MESSAGE ONLY NO RESPONSE Overpressure Alarm: PR3 NO RESPONSE NO RESPONSE NO RESPONSE PAUSE NO RESPONSE Overpressure Alert: PR4 NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE MESSAGE ONLY Overpressure Alarm: PR4 NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE PAUSE Overpressure Alert: PR8 MESSAGE ONLY NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Overpressure Alarm: PR8 MESSAGE ONLY NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE Pump Cover Open: PM1 NO RESPONSE PAUSE NO RESPONSE NO RESPONSE NO RESPONSE Pump Cover Open: PM2 NO RESPONSE NO RESPONSE PAUSE NO RESPONSE NO RESPONSE Pump Cover Open: PM3 NO RESPONSE NO RESPONSE NO RESPONSE PAUSE NO RESPONSE Pump Cover Open: PM4 NO RESPONSE NO RESPONSE NO RESPONSE NO RESPONSE PAUSE Note: Editing Bio-Pump and roller pump responses is determined by the presence of a box in the columns labeled “Stop, Coast, Pause, Message Only, and No Response.” If no box is present, that response cannot be edited. When operating in the Bio-Pump CPB mode, the Performer CPB comes pre-configured with factory default settings for the AutoClamp response to Safety System events. Reviewing these default settings is the responsibility of the System Administrator to ensure whether they conform to the conduct of the applicable perfusion protocols or whether settings need to be changed. The configuration options for the AutoClamp are either CLOSE or NO RESPONSE. Table 5-4. Default AutoClamp Responses The AutoClamp configuration options apply only to the following Safety System events: Default System Configuration Settings BIO-PUMP STOP NO RESPONSE BIO-PUMP COAST NO RESPONSE BIO-PUMP LOW FLOW NO RESPONSE Operator’s Manual A14113002 Rev. 2.0 5-23 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 System Configuration BIO-PUMP BACKFLOW CLOSE Note: All other Safety System events do not accommodate for user-defined configuration options for the AutoClamp The default setting is NO RESPONSE. To assign pump responses to safety systems events: 1. Press the Safety Systems Configuration button to open the screen for assigning pump responses to safety system events. 5 2 3 4 1 Figure 5-14. Assign Pump Responses to Safety Systems Events 2. Assign the Bio-Pump response (Stop, Coast, Message Only, No Response) for the configurable event in the bar at the top of the screen. 3. Assign the roller pump response (Stop, Pause, Message Only, No Response) for the configurable event in the bar at the top of the screen. 4. Assign the AutoClamp response (Close, No Response) for the configurable event in the bar at the top of the screen (Bio-Pump CPB mode only). 5. Use the left/right scroll arrows to select each configurable safety system event and repeat steps 2 - 4 to assign the desired Bio-Pump, roller pump, and AutoClamp responses. Table 5-5. Configurable Safety System Events 5-24 A14113002 Rev. 2.0 Event Description USED IN RESTING HEART USED IN BIO-PUMP CPB AIR DETECTED BY ABD (ALARM) Occurs when the Transonic™ arterial flow transducer with air bubble sensor detects air. YES YES AIR IN CARDIOPLEGIA CIRCUIT (ALARM) Occurs when the cardioplegia ultrasonic air/fluid sensor detects air. YES YES AIR IN VARD (ALERT) Occurs when air is detected by the upper pair of ultrasonic sensors in the VARD. YES NO TOO MUCH AIR IN VARD (ALARM) Occurs when air is detected by the lower pair of ultrasonic sensors in the VARD. YES NO Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use System Configuration Event Description USED IN RESTING HEART USED IN BIO-PUMP CPB LOW BLOOD LEVEL ALERT Occurs when fluid in the reservoir drops below the position of the yellow level sensor. NO YES LOW BLOOD LEVEL ALARM Occurs when the fluid in the reservoir drops below the position of the red level sensor. NO YES BIO-PUMP STOP Occurs when the Bio-Pump enters the Stop Mode. YES YES BIO-PUMP COAST Occurs when the Bio-Pump enters the Coast Mode. YES YES BIO-PUMP BACKFLOW (ALERT) Occurs when negative flow is detected by the TransonicTM arterial flow transducer. YES YES BIO-PUMP LOW FLOW (ALERT) Occurs when the arterial flow detected by the TransonicTM arterial flow transducer drops below the low flow limit selected in the Bio-Pump Setup Screen and the pump RPM is greater than 2000. YES YES BIO-PUMP HIGH FLOW (ALERT) Occurs when the Bio-Pump is in the Venous Line Pressure Servo Mode and the pump speed exceeds 125% of the speed when servo was engaged. YES YES OVERPRESSURE ALERT: VLP Occur when the Venous Line Pressure (VLP) limits selected in the Bio-Pump Setup Screen are exceeded. (See “Pressure Mode Selection” on page 5-84.) YES NO Occur when the Arterial Line Pressure (ALP) limits selected in the Bio-Pump Setup Screen are exceeded. (See “Pressure Mode Selection” on page 5-84.) YES YES OVERPRESSURE ALARM: VLP OVERPRESSURE ALERT: ALP OVERPRESSURE ALARM: ALP Operator’s Manual A14113002 Rev. 2.0 5-25 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 System Configuration Event Description OVERPRESSURE ALERT: PR1 OVERPRESSURE ALARM: PR1 USED IN RESTING HEART USED IN BIO-PUMP CPB Occur when the line pressure limits selected in the Roller Pump Setup Screen are exceeded. (See “Roller Pump Pressure Channel Limit Settings” on page 5-86.) YES YES Occur when the line pressure limits selected in the Roller Pump Setup Screen are exceeded. (See “Roller Pump Pressure Channel Limit Settings” on page 5-86.) NO YES Occur when the line pressure limits selected in the Roller Pump Setup Screen are exceeded. (See “Roller Pump Pressure Channel Limit Settings” on page 5-86.) YES YES Occur when the interlock sensor on the pump cover is lifted off the pump housing. YES YES OVERPRESSURE ALERT: PR2 OVERPRESSURE ALARM: PR2 OVERPRESSURE ALERT: PR3 OVERPRESSURE ALARM: PR3 OVERPRESSURE ALERT: PR4 OVERPRESSURE ALARM: PR4 OVERPRESSURE ALERT: PR5 OVERPRESSURE ALARM: PR5 OVERPRESSURE ALERT: PR7 OVERPRESSURE ALARM: PR7 OVERPRESSURE ALERT: PR8 OVERPRESSURE ALARM: PR8 PUMP COVER OPEN: PM1 PUMP COVER OPEN: PM2 PUMP COVER OPEN: PM3 PUMP COVER OPEN: PM4 5-26 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use System Configuration Table 5-6. Bio-Pump and Roller Pump Response Definitions Response Definition Stop A Stop response causes the pump speed to go to zero and the motor to enter the Stop Mode. The pump must be restarted manually after the event is cleared or the safety system is disabled. If a Stop response is executed while the centrifugal pump is in the Servo Mode, the pump will switch to the Manual Mode after it is restarted. Coast (for Bio-Pump only) In the Resting Heart mode, a Coast response causes the Bio-Pump speed to reduce to a flow of 0.5 L/min. As the pump speed adjusts to achieve 0.5 L/min, the transient RPM change may not be sufficient to prevent backflow or may be high enough to allow some forward flow. The pump flow will remain at 0.5 L/min until the event is cleared or the safety system is disabled. The pump speed will then automatically ramp up its speed to the previous level. Warning: If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY ABD” alarm, pump flow will remain at 0.5 L/min and will not automatically ramp up after the air is no longer detected by the ABD or after the ABD is turned off. Flow can only be resumed manually after careful assurance that air has been completely removed from the arterial circuit. In the Bio-Pump CPB mode, a Coast response causes the Bio-Pump speed to be reduced to an RPM of 2000. This RPM may not generate sufficient pressure to prevent backflow, or it may be enough to allow some forward flow. The pump will remain at 2000 RPM until the event is cleared or the safety system is disabled. The pump speed will then automatically ramp up its speed to the previous level. Warning: If the Bio-Pump enters the Coast mode in response to the “AIR DETECTED BY ABD” alarm, pump speed will remain at 2000 RPM and will not automatically ramp up after the air is no longer detected by the ABD or after the ABD is turned off. Flow can only be resumed manually after careful assurance that air has been completely removed from the arterial circuit. Pause (for roller pumps only) A Pause response causes the roller pump speed to be temporarily reduced to zero. The speed remains at zero until the event is cleared or the safety system is disabled. The pump will then automatically start and gradually ramp up its speed to the previous/original level. Message Only A Message Only response causes a message about the event to appear in the top line of the message bar. The message may occur concurrent with the other visual and audible cues representing an alert or alarm condition. No Response If No Response is selected, then no safety system connection is established between the device and the pump. The AutoClamp System incorporates a pneumatically powered tube clamp on the arterial line that serves to prevent retrograde flow from the aorta into the venous reservoir when the Bio-Pump events STOP, COAST, BACKFLOW, or LOW FLOW occur. Table 5-7. AutoClamp Response Definitions Response Definition CLOSE A CLOSE response causes the solenoid valve in the AutoClamp Interface Module to release gas pressure and allow the spring clamp in the Remote Tube Clamp to pinch the tubing. The clamp remains in the CLOSE position until (1) the AutoClamp is disabled or (2) the condition that initiated the clamp to CLOSE has been corrected. NO RESPONSE If NO RESPONSE is selected, then no safety system connection is established between the AutoClamp and the Bio-Pump event. Note: These configuration options are only selectable when running the Bio-Pump CPB mode. Operator’s Manual A14113002 Rev. 2.0 5-27 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 System Configuration Configuring User Preferences The Performer CPB User Preferences screens allow the user the following entry or selection options: ■ Hospital or organization names ■ One or two-sensor Level Detection mode ■ Enabling or disabling the AutoClamp option ■ One-pump or two-pump cardioplegia delivery mode ■ Low Flow Alert ■ Low Hematocrit Alert ■ Low Oxygen Saturation Alert ■ Acoustic Signal Tone quality and volume setting ■ Languages ■ Local date and time ■ New Password ■ Referencing the software version Press the User Preferences Configuration button the following settings. and scroll left/right to configure General Data Configuration 4 1 2 3 1. 2. 3. 4. 5-28 A14113002 Rev. 2.0 Operator’s Manual Enter Hospital name. Enter Organization name, if applicable. Enter Notes, if applicable. Scroll right to view the Miscellaneous Screen. PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use System Configuration Miscellaneous 9 1 2 5 8 3 6 4 7 1. In the LEVEL SENSORS window, select whether Level Detection will utilize zero, one or two level sensors. Press the box under the desired configuration (0, 1 or 2) and the green check will move to that box confirming the selection. If one sensor will be used, select the Alert (upper) or Alarm (lower) sensor by pressing the lavender button below the green check. (Bio-Pump CPB mode only) 2. In the AUTOCLAMP window, select whether the AutoClamp System will be used. Press the box under the desired configuration (0 = OFF, 1 = ON) and the green check will move to that box confirming the selection. (Bio-Pump CPB mode only) 3. In the CARDIOPLEGIA MODE window, press to select whether cardioplegia delivery will utilize a ONE PUMP configuration or a TWO PUMP configuration. 4. In the CARDIOPLEGIA MODE window, confirm the drug tube is either 1/8” ID or 1/4" ID. Press the button to change. 5. In the ALERT LIMITS window, confirm the LOW FLOW alert limit value. Press the value to edit. The LOW FLOW pop-up window will appear. Press the Up/Down arrows in the pop-up window to change. Press the edited value to accept. 6. In the ALERT LIMITS window, confirm the low OXYGEN SAT alert limit value. Press the value to edit. The OXYGEN SAT pop-up window will appear. Press the Up/Down arrows in the pop-up window to change. Press the edited value to accept. 7. In the ALERT LIMITS window, confirm the low HEMATOCRIT alert limit value. Press the value to edit. The HEMATOCRIT pop-up window will appear. Press the Up/Down arrows in the pop-up window to change. Press the edited value to accept. 8. In the DISPLAY CONTRAST window, the settings pertain to the brightness/ contrast of the roller pump displays. Press the button for each pump to open the pop-up window that allows the user to adjust the contrast of the corresponding LCD roller pump display on the front of the console. 9. Scroll right to view the Acoustic Signals Configuration Screen. Operator’s Manual A14113002 Rev. 2.0 5-29 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 System Configuration Acoustic Signals Configuration 7 1 2 3 4 Resting Heart mode only: 1. Press and select VARD ALERT. 2. Press the << or >> buttons to scroll through seven options for acoustic tones and one option for voice (Option 8). 3. Press the > button to preview the acoustic tone option selected in step 2. 4. Press the -/+ buttons to set volume. Note: The volume of Sound 1 for VARD Alert and VARD Alarm cannot be adjusted. 5. Repeat steps 1 through 4 for each of the following: a. GENERIC ALERT b. VARD ALARM 6. For the VOICE MESSAGES (Option 8): a. Press > to preview the volume for voice messages. b. Press -/+ to set the volume. c. Press << or >> to either enable or disable all of the following voice messages. ■ MESSAGE 1: “Welcome to Performer CPB” will sound at start-up. ■ MESSAGE 2: “Make Your Choice” will sound after successful completion of the Power On Self-Test and when the Home Screen appears. ■ MESSAGE 3: “Treatment Activation” will sound after the Resting Heart button on the Home Screen is pressed. ■ MESSAGE 4: “Enter Password” will sound after the System Configuration button is pressed and the Password Screen appears. ■ MESSAGE 5: “Password Correct” will sound after the System Password is properly entered. ■ MESSAGE 6: “Password Incorrect; Try Again” will sound if the System Password is improperly entered. MESSAGE 7: “See You Next Time” will sound when the Home Button is pressed. 7. Scroll right to view the Password Configuration Screen. ■ Bio-Pump CPB mode only: 1. Press and select LEVEL SENSOR ALERT. 2. Press the << or >> buttons to scroll through seven options for acoustic tones and one option for voice (Option 8). 3. Press the > button to preview the acoustic tone option selected in step 2. 4. Press the -/+ buttons to set volume. 5. Repeat steps 1 through 4 for each of the following: a. LEVEL SENSOR ALARM b. VOICE MESSAGES 5-30 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use System Configuration c. ALERT 6. For the VOICE MESSAGES (Option 8): a. Press > to preview the volume for voice messages. b. Press -/+ to set the volume. c. Press << or >> to either enable or disable all of the following voice messages. ■ MESSAGE 1: “Welcome to Performer CPB” will sound at start-up. ■ MESSAGE 2: “Make Your Choice” will sound after successful completion of the Power On Self-Test and when the Home Screen appears. ■ MESSAGE 3: “Treatment Activation” will sound after the Bio-Pump CPB button on the Home Screen is pressed. ■ MESSAGE 4: “Enter Password” will sound after the System Configuration button is pressed and the Password Screen appears. ■ MESSAGE 5: “Password Correct” will sound after the System Password is properly entered. ■ MESSAGE 6: “Password Incorrect; Try Again” will sound if the System Password is improperly entered. MESSAGE 7: “See You Next Time” will sound when the Home Button is pressed. 7. Scroll right to view the Password Configuration Screen. ■ Password Configuration 1 2 1. Press the keypad buttons to configure new system administrator password numbers which appear in the “NEW” row. 2. Press the Confirm button to accept the new password. Language Configuration 1 2 1. Press or to select the desired language. 2. Press to confirm the language selection. When confirmed, the letters will change from black to red. The selected language takes effect immediately. Operator’s Manual A14113002 Rev. 2.0 5-31 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 System Configuration Date and Time Configuration 1 2 1. Press a Time Unit button (year, month, day, hour, or minute) to open a pop-up window displaying the selected unit of time. 2. Press the Up/Down increment buttons to change the value in the pop-up window. Confirm by pressing the new value box in the pop-up window. The new value will appear in the selected Time Unit button. Software Version Displays information for service technicians regarding the installed software version in the Performer CPB. Configure Service Settings Access to the service configuration settings is restricted to Medtronic service technicians only. Saving Configuration Settings The system enables for multiple configurations to be saved and identified as individual PROFILE names. After all configuration settings are made: 1. Press on the Menu Bar. The SYSTEM PROFILE window will appear requesting the user to: 5-32 A14113002 Rev. 2.0 Operator’s Manual ■ Save Changes ■ Save as New Profile ■ Exit Without Saving PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use System Configuration 2. Press “Save As New Profile” after completing new configuration settings to be saved under a unique file name. The screen will revert to a USER PROFILES screen with a keyboard for entering the name of the new profile. 4 5 3. Type the new name using the keyboard. As the letters are entered, they will appear in the blue highlighted bar under ACTIVE PROFILE. 4. Press the bar to accept the new name. The system will save the new profile and add the name to the list under AVAILABLE PROFILES. The new profile also appears as the ACTIVE PROFILE (green highlighted). 5. The screen will revert to the Home screen. Note: SYSTEM PROFILE (yellow highlighted) is the file that contains the Factory Default settings and cannot be edited or renamed. Note: When making configuration edits to the active profile that do not warrant creating a new profile name, press SAVE CHANGES. The changes will be saved in the file in the ACTIVE PROFILE window and the screen will revert to the Home screen. Operator’s Manual A14113002 Rev. 2.0 5-33 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 System Configuration Navigating in the USER PROFILES Screen Use NEW to create a new profile name. 1. Press NEW. The screen with the keyboard will be displayed. 2. Type the new profile name. As the letters are entered, they will appear in the blue bar under ACTIVE PROFILE. 3. Press the bar to accept the new name. The system will save the new profile and add the name to the list under AVAILABLE PROFILES. The new profile also appears as the ACTIVE PROFILE (green highlighted). Note: The Configuration settings in this file will be the same as those in the Factory Default settings (Table 5-1). Use COPY to create a profile that is a copy of an existing one (created by user). 1. Press the Up/Down scroll arrows to highlight the profile name to be copied. 2. Press COPY. The screen with the keyboard will be displayed. Enter a name for this new profile. As the letters are entered, they will appear in the blue bar under ACTIVE PROFILE. 3. Press the bar to accept the new name. The system will save the new profile and add the name to the list under AVAILABLE PROFILES. The new profile also appears as the ACTIVE PROFILE (green highlighted). Note: After changes are made to a profile and are ready to be saved, press the Home button. A window will open with the profile name at the top. SAVE CHANGES must be pressed before the changes become effective and can be displayed when you press the VIEW button. Use RENAME to change the name of a profile. 1. Press the Up/Down scroll arrows to highlight the profile name to change. 2. Press RENAME. The screen with the keyboard will be displayed. Enter the new name. As the letters are entered, they will appear in the blue bar under ACTIVE PROFILE. 3. Press the bar to accept the new name. The system will save the new profile and add the name to the list under AVAILABLE PROFILES. Use DELETE to remove a profile from memory. 1. Press the Up/Down scroll arrows to highlight the profile name to delete. 2. Press DELETE. A window will appear asking “DO YOU REALLY WANT TO DELETE THIS PROFILE?” 3. Press the Green check to delete. 5-34 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use System Start-up Use VIEW to display the configuration settings for a certain profile. 1. Press the up/down arrows to select the profile to be viewed (highlighted in yellow). 2. Press VIEW. The first screen will display a table with NAME, UNITS and TUBE columns for the roller pumps, NAME, ALERT and ALARM columns for the Pressure Channels and a NAME column for the Temperature channels. 3. Press the Right Scroll Arrow. The next screen will display a table of the Safety System responses for the Bio-Pump, the roller pumps, and the AutoClamp. 4. Press the Right Scroll Arrow. The next screen will be a continuation of the table showing Safety System responses for the Bio-Pump, roller pumps and the AutoClamp. 5. Press the Right Scroll Arrow. The last screen will be a table of the selected User Preferences. 6. Press to return to the USER PROFILES screen. Use the USE button to assign a profile from the list as the ACTIVE PROFILE. 1. Press the Up/Down scroll arrows to highlight the profile name to use. 2. Press USE. The name of the selected profile will appear in the bar under ACTIVE PROFILE. System Start-up To begin using the Performer CPB, plug the console into an appropriate AC power outlet, lift the CID, and turn on the Main Power switch. The CID will display “SYSTEM INITIALIZATION” for several seconds, followed by the Power On Self-Test (POST) screen (see “Power On Self-Test” on page 5-17 for procedure). Home Screens After the Power On Self-Test (POST) functions indicate PASSED, the display will automatically proceed to the Home Screen (See Figure 5-15). While in the Home Screen, the user can adjust the height by pressing the console Up/Down switches. Note: The press-and-release function of the console Up/Down switches are disabled after leaving the Home Screen and entering an operational mode. To adjust the height, the user must press and hold the respective Up or Down switch until the desired height is reached. 1 2 3 4 5 Figure 5-15. Resting Heart and Bio-Pump CPB Home Screens 1. Press “RESTING HEART” to operate the Medtronic Resting Heart mode. Operator’s Manual A14113002 Rev. 2.0 5-35 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 System Start-up 2. Press “BIO-PUMP CPB” to operate an extracorporeal circuit using gravity drainage to a venous reservoir. 3. Press “SYSTEM PROFILE” (or the field with the user icon) to configure the User Profiles. 4. Press “SYSTEM CONFIGURATION” to configure the system settings (see page 5-18). 5. Press “LOAD BIO-PUMP CPB” or “LOAD RESTING HEART” to switch between using these two modes. Entering Resting Heart Mode Press the RESTING HEART button on the Home Screen to operate the system when using the Medtronic® Resting Heart® Module. The Resting Heart® Module is a completely integrated, closed-loop extracorporeal circuit which consists of a Bio-Pump+® Centrifugal Blood Pump, a Bio-Probe® flow sensor, an AFFINITY® NT Oxygenator, an AFFINITY® Arterial Filter, and an AFFINITY® Venous Air Removal Device. All non-silicone blood contact surfaces are prepared with Carmeda®1 BioActive Surface unless otherwise specifically noted. Warning: Only persons thoroughly trained in cardiopulmonary bypass procedures should use this bypass circuit. Operation of the bypass circuit requires constant supervision by qualified personnel for patient safety. Entering Bio-Pump CPB Mode Press the BIO-PUMP CPB button on the Home Screen to operate the system when using an extracorporeal circuit with a reservoir. Warning: Only persons thoroughly trained in cardiopulmonary bypass procedures should use this bypass circuit. Operation of the bypass circuit requires constant supervision by qualified personnel for patient safety. Screen Design and Operation The main interface enables the user to interact with the Performer CPB equipment through a color graphic display and a touch screen system that activates the various functions represented on the screen. The display is divided into well-defined zones for every available perfusion mode and consistent information areas are always visible. The touch screen display allows the user to: 1 5-36 A14113002 Rev. 2.0 ■ select the delivery modes ■ monitor the various perfusion parameters ■ display all the parameters (pressures, flows, temperatures) ■ set the safety limits ■ read message alarms and warnings Carmeda® is a registered trademark of Carmeda A.B. Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use System Start-up 1 2 5 3 4 5 Figure 5-16. Main User Interface Components (Bio-Pump CPB mode) 1. 2. 3. 4. 5. Message Bar Main Menu Cardioplegia Control Screen Main Run Screen Timers The Performer CPB screen also uses unique graphic pictures and icons to display information. Read-Only Screen Graphics The screen areas or icons that do not change when pressed are designated as “Read-Only.” These areas or icons provide dynamic information to the user about the status of the components or systems and update as conditions change. Examples are: Message Bar Air in VARD (Resting Heart mode only) Low Suction (Resting Heart mode only) Static Function Buttons Screen areas and icons that enable the user to navigate to a different screen or activate/deactivate a device are designated as static function buttons. The graphics of static function buttons do not change when pressed. Examples are: Operator’s Manual A14113002 Rev. 2.0 5-37 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 System Start-up Home Button Bio-Pump Setup Button Roller Pump Setup Button Cardioplegia Mode Selection Button Safety System Screen Patient Information Button Parameters Screen Button Trending Screen Button Events Log Button Print Button SAT/HCT Offset Button Main Menu Button Calculator VARD Screen Call-up Button (Resting Heart mode only) Level Sensor Screen Call-up Button (Bio-Pump CPB mode only) Dynamic Function Buttons Dynamic function buttons provide information to the user and are used to activate/deactivate devices. These buttons also change appearance to indicate a change in the status of the device or the system the icon represents. Examples are: ■ 5-38 A14113002 Rev. 2.0 Operator’s Manual Air Bubble Detector (ABD) PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use System Start-up The gray icon with a red X indicates the ABD is disabled. Pressing the gray icon enables the ABD, which then changes the icon to green with a green checkmark. Detecting air causes the ABD icon to change to red, indicating “Air Detected.” ■ Pinch Valve (Resting Heart mode only) The green icon indicates the pinch valve is closed. Pressing the green icon causes the pinch valve to open for 0.5 seconds. The icon changes to red while the valve is open. ■ Arterial AutoClamp (Bio-Pump CPB mode only) The yellow icon is used to initiate the AutoClamp Self Test. The grey icon with a red X indicates the AutoClamp is off. Pressing the grey icon turns the AutoClamp to ON. The icon then changes to green with a green checkmark. Activation of the AutoClamp causes the icon to change to red with an exclamation mark. ■ VARD Servo (Resting Heart mode only) Pressing the VARD Servo button changes the icon from gray to “colored,” indicating the VARD Servo Mode is enabled. When the VARD Servo Mode is enabled, the VARD icon in the AAR Screen changes to a dynamic function button. Pressing this button enables and disables the upper ultrasonic sensors for Servo Mode operation. Operator’s Manual A14113002 Rev. 2.0 5-39 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 System Start-up Several icons or screen areas are color-coded with the shade lavender the user to easily identify them as dynamic function buttons. to assist An example is: ■ Cardioplegia Delivery Mode The two lavender icons with the roller pumps represent the One-Pump Mode for cardioplegia delivery. Pressing this button will change the appearance to represent the Two-Pump Mode for cardioplegia delivery (see below). The single lavender icon with the roller pumps represents the Two-Pump Mode for cardioplegia delivery. Pressing this button will change the appearance to represent the One-Pump Mode for cardioplegia delivery (see above). System Alerts and Alarms System Alerts The console, CID, and touch screen incorporate distinct visual and audible system alerts intended to elevate the user's awareness when: ■ a safety device is activated ■ user-defined or default operational limits of a system are exceeded ■ an event occurs ■ an electromechanical or software malfunction occurs Alerts are typically associated with: ■ the system status LED changing to yellow ■ the sounding of a distinctive audible alert tone defined by the user ■ a description of the event(s) in the top line of the message bar ■ (User Option) automatic change in a pump function to prevent or stop the alert condition System Alarms For alarms, the console, CID, and touch screen incorporate distinct visual and audible system alerts intended to elevate the user’s awareness when: ■ a safety device is activated ■ user-defined or default operational limits of a system are exceeded ■ an event occurs ■ an electromechanical or software malfunction occurs The system then, concurrently, may activate user-defined options to automatically stop the malfunction or prevent the limits from being exceeded. Alarms are always associated with: 5-40 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Main Run Screen ■ the system status LED changing to red ■ the sounding of a distinctive audible alarm tone defined by the user ■ the message bar changing to red ■ a description of the event(s) in the top line of the message bar ■ a description of a change in the Bio-Pump status in the second line of the message bar Main Run Screen The Main Run Screen (Figure 5-17) always displays the physiologic parameters pertinent to maintaining the hemodynamic and metabolic support to the patient during cardiopulmonary bypass (CPB). The display differs depending on the current mode, but there are a number of shared components. 4 5 3 10 4 14 5 6 7 3 8 13 9 8 7 9 6 11 2 2 12 1 1 Resting Heart Main Run Screen Bio-Pump CPB Main Run Screen Figure 5-17. Main Run Screens 1. Bio-Pump RPM: Turn the pump speed RPM knob clockwise to increase the RPM of the remote drive motor. Monitor pump speed (RPM) in correlation with blood flow. Warning: To prevent backflow of the patient’s blood when the pump outlet tubing is open, establish and maintain a minimum pump speed that overcomes line and patient resistance. Use the AutoClamp System on the arterial line in Bio-Pump CPB mode. Failure to do this could allow retrograde flow and exsanguinate the patient. Warning: All gaseous bubbles have the potential for gaseous emboli and must be dealt with carefully. Using Safety Devices (Arterial Line Air Bubble Detector, VARD) and Safety Systems (Bio-Pump Backflow Alert, AutoClamp) are recommended to aid in the detection and elimination of gaseous bubbles in the extracorporeal circuit. 2. Flow: To display and monitor blood flow, attach the doppler ultrasound flow transducer to the arterial line of the extracorporeal circuit. It is recommended that this placement occurs downstream of the arterial filter. Ensure that the direction of the arrow on the face of the sensor is in the same direction of fluid flow. The sensor will detect flow of both electrolyte solutions and blood. Operator’s Manual A14113002 Rev. 2.0 5-41 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Main Run Screen 3. T1 and T2: The Main Run Screen is configured to display two temperatures, T1 and T2. Connect a YSI™ Series 400 compatible temperature probe to the jack labeled T1 on the back of the console to monitor the temperature in the T1 display (see the arterial circuit). Connect a YSI™ Series 400 compatible temperature probe to the jack labeled T2 on the back of the console to monitor the temperature in the T2 display (see the venous circuit). 4. Air Bubble Detector (ABD): The doppler ultrasonic flow probe includes an integral macro-air bubble detector. The ABD icon on the Main Run Screen defaults to the ABD Disabled Mode when the system is powered up. The top line of the message bar will display “ABD OFF.” To activate or enable the air bubble detection function, press the ABD DISABLED icon. When enabled, the ABD icon will change to ABD ENABLED and the display “ABD OFF” will clear from the top line of the message bar. In the event arterial air is detected, the ABD icon will change to AIR DETECTED. 5. Arterial Line Pressure (ALP): To display the arterial line pressure, connect a pressure monitoring line with an isolator between a stopcock in the arterial segment of the extracorporeal circuit and the pressure luer port labeled ALP. Ensure that the portion of the monitoring line from the circuit stopcock to the fluid isolator membrane is thoroughly primed. Warning: Do not introduce fluid into the male pressure luer connection on the console. 6. 7. 8. 9. By pressing the Pressure Mode button, the user can change the ALP display to read either systolic , mean , diastolic , or instantaneous pressure. Cardiac Index: In the Patient Information Screen (see “Patient Information” on page 5-100), ensure that the correct patient height (in cm) and weight (in kilograms) are entered. These parameters are then used to calculate the patient's Body Surface Area (BSA) in square meters. Cardiac index represents either the flow in liters per minute per square meter of body surface area (L/MIN/M2) or milliliters per minute per kilogram of body weight (ML/MIN/KG). Press to change the display to view either parameter. Oxygen Cons./Oxygen Deliv.: This display enables the perfusionist to continuously monitor the milliliters per minute of oxygen the patient is consuming or the milliliters per minute of oxygen being delivered to the patient. Oxygen consumption is based on the following calculation: OXYGEN CONS. = 1.39 x (Hct/3) x (.999 - OXYGEN SAT) x BLOOD FLOW x 10. Oxygen delivery is based on the following calculation: OXYGEN DELIV. = 1.39 x (Hct/3) x .999 x BLOOD FLOW x 10. Both equations rely on the continuous input from the Doppler ultrasound probe measuring the blood flow and the input from the optical probe measuring oxy-hemoglobin saturation and hematocit. Press to change the display to view either parameter. Hematocrit: When the probe used to monitor the oxy-hemoglobin saturation of mixed venous blood is connected to the 9.5 mm (3/8 in) connector/cuvette, it will simultaneously detect the hematocrit of the blood and display the value in the Hematocrit window. The unit of measure is percent (%). Press to adjust the low Hematocrit alert using the pop-up window. Oxygen Sat (%): To display the oxy-hemoglobin saturation of mixed venous blood, connect the optical probe to the 9.5 mm (3/8 in) connector/cuvette in the venous segment of the extracorporeal circuit. Press to adjust the low Oxygen Sat alert using the pop-up window. Resting Heart Mode only: 10. Venous Line Pressure (VLP): To display the venous line pressure, connect a pressure monitoring line with an isolator between a stopcock in the venous segment of the perfusion circuit and the pressure luer port labeled VLP. Ensure that the portion of the monitoring line from the circuit stopcock to the fluid isolator membrane is thoroughly primed. 5-42 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Medtronic Confidential CS017 Instructions for Use Main Run Screen Warning: Do not introduce fluid into the male pressure luer connection on the console. Zero the transducer (see “Zeroing the Pressure Transducers” on page 5-87). By pressing the Pressure Mode button, the user can change the VLP display to read either systolic , mean , diastolic , or instantaneous pressure. (See Figure 5-34 on page 5-88.) 11. VLP Servo: The VLP servo automates the relationship between pump RPM and changes in venous line pressure (VLP). When the VLP servo is engaged and the venous line pressure becomes more negative, the system automatically reduces pump RPM to facilitate a consistent VLP value. Note: The VLP servo does not override the Bio-Pump safety system responses for Coast or Stop. 12. VARD Servo: The VARD servo automates the relationship between pump RPM and the occurrence of air in the VARD. When the VARD servo is engaged and air enters the VARD, the system automatically reduces pump RPM to facilitate efficient removal of the air. The VARD servo overrides the pump responses set up for the “Air In VARD” and “Too Much Air In VARD” safety systems. The system will indicate with acoustic and visual indicators when air does enter the VARD. Bio-Pump CPB Mode only: 13. Level Detection: Used for detecting changes in fluid or blood volume in a reservoir. The Level Detection System utilizes a pair of color-coded sensors placed on the outside surface of a reservoir. The location is user-defined. The reservoir icon indicates the sensors are properly attached and sensing fluid in the reservoir. The Level Detection button enables the sensors so when the fluid/blood level in the reservoir moves above or below the position of a sensor, visual and audible cues occur to alert the user. The Bio-Pump and the roller pumps can also be configured to change their speed in response to the sensors detecting level changes. Warning: The level detection system must be properly set up and enabled prior to clinical use. Undetected emptying of the reservoir may result in gaseous emboli being pumped to the patient with attendant risk of death or serious injury. Warning: Verify the level detection system functions properly with the particular reservoir being used. Warning: The performance of the level detection system must be verified before each use. 14. AutoClamp: Displayed when the AutoClamp System is enabled and a pneumatically powered tube clamp is placed on the arterial line. The clamp can be configured to close when the Bio-Pump run mode changes (STOP, COAST, LOW FLOW) or the arterial flow sensor detects backflow. Closing the clamp prevents retrograde flow from the aorta into the venous reservoir and prevents introducing air into the arterial line. The AutoClamp icon on the Main Run Screen defaults to the SELF TEST READY Mode when the system is powered up. Press to conduct the Self Test. When passed, the icon changes to AUTOCLAMP OFF. When pressed, the icon changes to AUTOCLAMP ON. When triggered to close, the icon changes to AUTOCLAMP CLOSED. When the red AUTOCLAMP CLOSED is pressed, the icon changes to the AUTOCLAMP OFF icon. Warning: Prior to configuring the AutoClamp to CLOSE when the Bio-Pump enters the COAST mode, it is the user's responsibility to test the extracorporeal circuit and confirm the conduct of perfusion at their institution does not generate arterial backflow when the Bio-Pump enters the COAST mode or when the Bio-Pump speed is manually reduced to the “detent” position. Operator’s Manual A14113002 Rev. 2.0 5-43 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Main Run Screen Checking the Battery Integrated batteries provide uninterruptible battery backup power in the event wall power is lost. During AC power loss, fully charged batteries will supply enough power to operate a fully loaded system for 30 minutes. Fully loaded is defined as follows: PM1: 1000 mL/min with 9.5 mm (3/8 in) x 2.4 mm (3/32 in) tubing PM2: 100 mL/min with 6.4 mm (1/4 in) x 1.2 mm (1/16 in) tubing PM3: Stopped PM4: 400 mL/min (150 mm Hg back-pressure) with 6.4 mm (1/4 in) x 1.2 mm (1/16 in) and 3.2 mm (1/8 in) x 1.2 mm (1/16 in) tube set (2 tubes) Pinch valve: Cycled every 2 minutes Bio-Pump: 4.0 L/min Warning: If a partially charged battery is used, there may be less than 30 minutes of battery power available. Warning: When the Uninterruptible Power Supply (UPS) converts the system to battery power, ALL pumps, pump functions, safety systems, alerts, alarms, monitors, controls, the Pinch Valve and the Central Information Display (CID) are active and function the same as when the system is on AC power. The batteries will charge, as needed, while the system is operating from AC wall power. To check the battery charge: 1 3 1. Press to display the battery charge level in minutes. Battery charge level should be checked before each case. 2. Start the Bio-Pump remote drive motor and each roller pump. 3. Unplug the system from AC wall power. Confirm that the system automatically converts to battery power. 5-44 A14113002 Rev. 2.0 Operator’s Manual ■ The power status icon will change to “battery” and display the time remaining battery charge ■ The message bar will display “BATTERY MODE” ■ The system status LED will change to yellow ■ The audible alerts will sound PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Main Run Screen Warning: If the system does not convert to battery power, contact a Medtronic service technician. 4. Monitor the time remaining in the power status icon as the battery discharges. Reducing the power load on the system will extend the duration of battery backup power. 5. When the time remaining reaches 5 minutes: ■ the system status LED changes to red ■ the message bar changes to red ■ the top line of the message bar reads “LOW BATTERY” the audible alarm tone sounds 6. Plug the system back into the AC wall power. Confirm that the system automatically converts to AC wall power. ■ ■ the power status icon will change to “AC” ■ “BATTERY MODE” will clear from the top line of the message bar ■ the system status LED will change to green ■ the audible alerts will stop Operator’s Manual A14113002 Rev. 2.0 5-45 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Timers Timers Timer Overview The various timers on the Perfusion Screen are shown in Figure 5-18. The timers appear and function the same in both Resting Heart and Bio-Pump CPB modes. 4 3 3 1 3 2 Figure 5-18. Perfusion Screen Timers 1. 2. 3. 4. Pump Timer Clamp Timer Rezero Button Auxiliary Timer Pump and Clamp Timer Operation The screen buttons for the pump timer and the clamp timer function exactly the same. Start Timers Pump Timer REZERO BUTTON START BUTTON STOP BUTTON START BUTTON STOP BUTTON Clamp Timer REZERO BUTTON 5-46 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Timers To start a Timer, press the green Start button. The following will occur when the Start button is pressed: ■ the green icon will change to the red Stop button ■ the elapsed time in minutes and seconds will be displayed ■ the clock time when the Start button was pressed will be displayed Stop Timers Pump Timer STOP BUTTON REZERO BUTTON START BUTTON STOP BUTTON REZERO BUTTON START BUTTON Clamp Timer To stop the Timer, press the red Stop button. The following will occur when the Stop button is pressed: ■ the red icon will change to the green Start button ■ the elapsed time will be displayed ■ the clock time when the Stop button was pressed will be displayed and will immediately change to the Rezero button To re-start the Timer, press the green Start button. The following will occur when the Start button is pressed: ■ the green icon will change to the red Stop button ■ the elapsed time will resume where it stopped ■ the original clock time when the Start button was pressed will be displayed ■ the clock time when the Stop button was pressed will be displayed Press or to reset the timer to 000:00. Note: Repeated clock times when the Start and Stop buttons were pressed can be viewed using the Events Log Screen. Pressing the Pump Timer Start button is also linked to the following: ■ the saving of the perfusion data for download to the CompactFlash® memory card ■ the tracking of the data for trending ■ the saving of the perfusion data for printing Operator’s Manual A14113002 Rev. 2.0 5-47 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Timers ■ the enabling/disabling of the alarm “BIO-PUMP EXCESSIVE STOP” ■ the enabling/disabling of the alert “HEMATOCRIT: LOW VALUE” ■ the enabling/disabling of the alert “OXYGEN SATURATION: LOW VALUE” Note: If the pump timer is not put into the Stop Mode within 1 minute after the Bio-Pump is stopped, ■ the system status LED will change to red ■ the message bar will change to red ■ audible alarm tones will sound ■ the top line of the message bar will read “BIO-PUMP EXCESSIVE STOP” To silence the alarm, press the alarm mute button once. To reset the alarm, press the red Stop button on the pump timer. Pressing the Clamp Timer Start and Stop button is also linked to the following: ■ the enabling and disabling of the alert “NEXT CARDIOPLEGIA DOSE IS DUE” Auxiliary Timer To start the auxiliary timer, press the green Start button. The following will occur when the Start button is pressed: ■ the green icon will change to the red Stop button ■ the elapsed time in minutes and seconds will be displayed ■ the clock time when the Start button was pressed will be displayed START BUTTON REZERO BUTTON Press to reset the timer to 000:00. To stop the auxiliary timer, press the red Stop button. The following will occur when the Stop button is pressed: 5-48 A14113002 Rev. 2.0 ■ the red icon will change to the green Start button ■ the Rezero button will be displayed Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Cardioplegia Cardioplegia Delivery Mode Selection The system can deliver cardioplegia in two distinct modes, a Two-Pump Delivery Mode and a One-Pump Delivery Mode. When the Perfusion Operations Screen is first opened, the area defined as the Cardioplegia Control Screen defaults to display graphics for the previous delivery mode used. Two-Pump Delivery Mode The Two-Pump Delivery Mode uses the pump identified as PM4 for regulating the delivery of the blood portion of the cardioplegia mixture (see Figure 5-18). The pump identified as PM3 is used for regulating the delivery of the drug portion of the cardioplegia mixture. In the two-pump configuration, both pumps operate in tandem, with the blood pump (PM4) designated as the master pump and the drug pump (PM3) designated as the slave pump. The master pump Start/Stop button and pump speed RPM knob operate both pumps. One-Pump Delivery Mode The One-Pump Delivery Mode uses the roller pump identified as PM4 (See Figure 5-18). The ratio of the desired blood and drug mixture is achieved by putting two tubing segments of different dimension in PM4. Then PM3 can be used as a “free” pump (left heart venting, hemoconcentration, etc). In the one-pump configuration, each pump is independently operated using its dedicated Start/Stop button and pump speed RPM knob. 5 6 4 3 2 1 7 Figure 5-19. Two-Pump and One-Pump Cardioplegia Delivery Modes 1. 2. 3. 4. 5. Two-Pump (default) screen display. One-Pump screen display. Switches to the One-Pump configuration when pressed. Switches to the Two-Pump configuration when pressed. Allows the selection of either 6.4 mm (1/4 in) or 3.2 mm (1/8 in) drug tubing ID to be used in PM3 of the two-pump configuration. 6. Allows the selection of either 6.4 mm (1/4 in) or 3.2 mm (1/8 in) drug tubing ID to be used in the one-pump configuration. 7. Pressing the green checkmark accepts the configuration (one-pump or two-pump) and the tubing dimensions for the one-pump or two-pump configuration. Operator’s Manual A14113002 Rev. 2.0 5-49 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Cardioplegia Preview Buttons After the one-pump or two-pump configuration is accepted, a sequence of preview buttons appears, which allows for specific setup, delivery, or timer settings. Setup Parameters Screen Run Timers Screen 1 Delivery Parameters Screen 3 2 Figure 5-20. Screen Preview Buttons 1. When pressed, will preview the Cardioplegia (CPG) Setup Parameters Screen. 2. When pressed, will preview the CPG Delivery Parameters Screen. 3. When pressed, will preview the CPG Run Timers Screen. Volume Tracking Cardioplegia Blood:Drug Ratio The volume tracking setup parameters are the same for both the One-Pump and Two-Pump Delivery Modes, with the exception of the Ratio button that is found only in the screens for the Two-Pump Delivery Mode. Note: The system will track the cardioplegia volume delivered based on the combined flows from the master pump (blood) and the slave pump (drug). These flows are a function of the tube sizes entered in the Cardioplegia Delivery Mode Selection Screen and the pump RPM. 4 2 3 1 5-50 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Cardioplegia Figure 5-21. Entering the Two-Pump Blood:Drug Ratio Parameter To enter the blood:drug ratio: 1. Press the Blood:Drug Ratio button to change the blood:drug ratio in the pop-up window during setup or to edit during use. 2. Press the Up or Down arrow to select the desired value for the blood cardioplegia element. The range is from 0 to 15. 3. Press the Up or Down arrow to select the desired value for the drug cardioplegia element. The range is from 0 to 15. 4. Accept the selected ratio by pressing the label with the ratio and return to the full setup menu. Cardioplegia Dose The amount and duration of cardioplegia input to the patient can be controlled in a variety of ways. The Dose Mode button indicates the mode that will automatically stop the cardioplegia pump. Entering Cardioplegia Dose Settings - Volume Mode, Manual Mode or Time Mode Volume Mode Manual Mode Time Mode Figure 5-22. Configuring Cardioplegia Dose Settings 1. To track cardioplegia dosage manually, press the Volume Mode button to change to the Manual Mode. (See Figure 5-22.) The Manual Mode button will appear, indicating that the user must manually stop the pump by either (a) pressing the Start/Stop button on the Cardioplegia Pump Control Panel, or (b) pressing the Volume Tracking Stop button when the desired amount of cardioplegia has been delivered. 2. To track cardioplegia dosage by time, press the Manual Mode button to change to the Time Mode. (See Figure 5-22.) The Time Mode button will appear, indicating that the cardioplegia pump will automatically stop when a user-preset delivery time (in minutes) has been reached. 3. Press to open the Dose Time pop-up window and enter the desired time in minutes. 4. To track cardioplegia dosage by volume, press the Time Mode button to change to the Volume Mode. (See Figure 5-22.) The Volume Mode button will appear, indicating that the cardioplegia pump will automatically stop when a user-preset dose of cardioplegia (in milliliters) has been infused. 5. Press to open the Dose Volume pop-up window and enter the desired volume in milliliters. Operator’s Manual A14113002 Rev. 2.0 5-51 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Cardioplegia Cardioplegia Volume and Time Tracking 1 2 Total Dose Pop-up Window Time Between Doses Pop-up Window Figure 5-23. Cardioplegia Volume and Time Tracking 1. displays the total of the cumulative volume of the cardioplegia mixture delivered from each dose. Press to edit this volume using the Total Dose pop-up window. 2. Press to set the Time Between Dose using the Time Between Doses pop-up window. 3 Time to Next Dose 4 5 Time Since Last Dose 3. Time to Next Dose: When this timer reaches 00:00, ■ an audible tone sounds ■ the system status LED changes to yellow the top line in the message bar displays “NEXT CARDIOPLEGIA DOSE DUE” 4. When is pressed, it changes between Time to Next Dose and Time Since Last Dose displays. 5. Time Since Last Dose: When this timer reaches the user-set value displayed in the Time Between Dose button, ■ ■ an audible tone sounds ■ the system status LED changes to yellow ■ the top line in the message bar displays “NEXT CARDIOPLEGIA DOSE DUE” Note: The Time Since Last Dose timer continues to run until 5-52 A14113002 Rev. 2.0 Operator’s Manual is pressed. PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Cardioplegia Cardioplegia Circuit and Delivery Parameters 3 2 1 Setup Parameters Screen 5 4 Delivery Parameters Screen 1. Press to view the Delivery Parameters Screen. 2. Displays the total flow from PM4 (One-Pump Mode) or total flow from PM4 and PM3 (Two-Pump Master/Slave Mode). 3. Displays the pressure measured at PR4. To set up the pressure monitoring circuit, follow the procedures in “Pressure Monitoring Sets with Air/Fluid Isolators Setup” on page 5-88 and see Figure 5-33. Zero the transducer following the procedures in “Zeroing the Pressure Transducers” on page 5-87 and see Figure 5-32. Select safety limits for cardioplegia delivery (see Figure 5-31). 4. Displays the status of the cardioplegia air bubble detector. The default status of the CPG air detector is “enabled.” If a fluid-filled line from the CPG circuit is properly seated in the sensor, the icon will appear green. If the sensor is not detecting a fluid-filled line or it is detecting air in the CPG circuit: ■ the icon will be red ■ an audible alert tone will sound ■ the system status LED will display yellow ■ the top line of the message bar will display “AIR IN CARDIOPLEGIA CIRCUIT” After completing de-airing of the cardioplegia circuit, ensure a fluid filled segment of tubing from the outlet of the roller pump is properly seated into the cardioplegia Air Bubble Detector. ■ Open the tube latch on the cardioplegia Air Bubble Detector ■ Slide the primed segment into the opening, then close the latch. Pressing the Cardioplegia ABD icon when it is either green or red will disable the ABD and: ■ change the icon to gray ■ sound the audible alert tone ■ change the system status LED to yellow ■ display “CARDIOPLEGIA AIR SENSOR DISABLED” in the top line of the message bar Warning: A gray CPG air detector icon indicates the sensor is disabled and will not generate an alarm if air enters the cardioplegia circuit. Operator’s Manual A14113002 Rev. 2.0 5-53 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Cardioplegia 5. Displays the temperature measured using a YSI™ Series 400 Compatible temperature probe connected to T3 on the HST Module. Cardioplegia Delivery: Clinical Use Ensure the following before initiating delivery of cardioplegia: ■ A primed segment of the 6.4 mm (1/4 in) x 1.2 mm (1/16 in) CPG circuit tubing between the CPG pump outlet and a bubble trap is properly seated in the 6.4 mm (1/4 in) air sensor. ■ The cardioplegia ABD is enabled and the icon is green. Warning: A gray CPG air bubble detector icon indicates the sensor is disabled and will not generate an alarm if air enters the cardioplegia circuit. Press the gray icon to enable the CPG air detector indicated by a green icon. ■ The desired value (mm Hg) for PR4 (cardioplegia) pressure alert is set and the desired value (mm Hg) for cardioplegia pressure alarm is set. See Figure 5-31 to set pressure alert and alarm values. ■ The desired roller pump response settings are properly configured for the events “Air in Cardioplegia Circuit,” “PR4 Pressure Alert,” and “PR4 Pressure Alarm.” ■ The desired Bio-Pump response settings are properly configured for the events “Air in Cardioplegia Circuit,” “PR4 Pressure Alert,” and “PR4 Pressure Alarm.” ■ The desired cardioplegia dose volume or delivery time are entered. ■ A temperature probe from T3 on the HTS Module is connected to the temperature port on the cardioplegia set. 1 Setup Parameters Screen 1. Press Delivery Parameters Screen to begin volume tracking. ■ The Delivery Parameters Screen appears. ■ The green Volume Tracking Start button will change to the red Volume Tracking Stop button . ■ The Cardioplegia ABD status changes from “Standby Mode” to “Active Mode.” does not start the cardioplegia roller pump(s). Note: Pressing 2. Press the cardioplegia roller pump (PM4) Start/Stop button to start infusion of cardioplegia. Turn the RPM knob to achieve the desired flow. Monitor the CPG flow (mL/min), line pressure (mm HG), and solution temperature (T3). Note: In the Two-Pump Mode, pressing the Start/Stop button on PM4 (master pump) will simultaneously start PM3 (slave pump). These pumps will independently rotate at the speed necessary to achieve the blood:drug ratio displayed in the Ratio button . 5-54 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:03 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Cardioplegia During Cardioplegia Infusion 1 2 3 1. Displays the cumulative volume delivered (mL) resulting from repeat infusions. 2. Displays the volume delivered (mL) during the current infusion. 3. Displays the calculated time remaining (minutes:seconds) before the preset dose is delivered and the pump automatically stops. Note: In the Manual Mode, this timer counts up the elapsed time of cardioplegia delivery. or preset time is reached: 4. When the preset volume ■ the cardioplegia pump(s) will automatically stop (Volume and Time Modes only) ■ an audible tone will sound ■ the system status LED will momentarily change to yellow ■ the top line of the message bar will display “DOSE DELIVERED” ■ the Setup Parameters Screen will appear ■ The Time Since Last Dose timer will begin . It begins counting up starting with 00:00 when the cardioplegia pump is automatically or manually stopped. ■ The Time to Next Dose timer will begin . Starting with the minutes set in the Time Between Doses button, it begins counting down when the cardioplegia pump is automatically or manually stopped. Operator’s Manual A14113002 Rev. 2.0 5-55 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Cardioplegia 5. Press to manually stop CPG delivery if using the Manual Mode pressed, ■ the CPG roller pump(s) will stop ■ the Setup Parameters Screen will appear ■ the Time Since Last Dose timer will begin ■ the Time to Next Dose timer will begin . When Note: Pressing the Stop button on the roller pump control panel stops CPG infusion but it does not stop CPG volume tracking. To stop volume tracking, press the red Volume Tracking Stop button. 5 Cardioplegia Delivery Air Detection Alerts and Alarms Indicates the CPG ABD is disabled and will not detect air in the circuit. When disabled, ■ the system status LED will be yellow ■ an audible alert tone will sound ■ the top line of the message bar will display “CARDIOPLEGIA AIR SENSOR DISABLED” Indicates the CPG ABD is enabled, the 6.4 mm (1/4 in) air sensor detects a fluid-filled line, and the CPG ABD is in “Standby Mode.” 5-56 A14113002 Rev. 2.0 Operator’s Manual ■ Used to test the CPG ABD when priming and recirculating the CPG circuit. ■ The ABD icon will change to red if air is detected, but it will not generate an alarm condition. PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Cardioplegia Indicates the CPG ABD is enabled, the 6.4 mm (1/4 in) air sensor detects a fluid-filled line, the CPG ABD is in the “Active Mode,” and volume tracking is on. Indicates air detected by the CPG ABD and initiates an alarm condition that includes: ■ the sounding of audible alarm tones ■ the system status LED changing to red ■ the message bar changing to red ■ the top line of the message bar displaying “AIR IN CARDIOPLEGIA CIRCUIT” ■ the CPG roller pump changing to the Stop Mode To resume CPG delivery, ■ mute the alarm ■ ensure all air in the circuit is thoroughly purged ■ reset the CPG ABD and ensure the icon is green Note: When CPG delivery is stopped due to an alarm condition, volume tracking is not reset. ■ turn the pump speed RPM knob fully counterclockwise ■ press the Start/Stop button, slowly turn the pump speed RPM knob clockwise, and resume CPG delivery Operator’s Manual A14113002 Rev. 2.0 5-57 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 AAR Controller - Venous Air Removal Device (Resting Heart mode only) AAR Controller - Venous Air Removal Device (Resting Heart mode only) Overview The Medtronic® AAR Controller and the Medtronic® Affinity® Venous Air Removal Device (VARD) combine to form a safety system for sensing air in the Resting Heart™ System and then activating a pinch valve that opens a vacuum line for removing air that may enter the venous circuit. This minimizes the probability of venous air reaching the Bio-Pump and potentially being transmitted to the patient. Two pairs of ultrasonic fluid sensors in the VARD will detect changes in the air/fluid level within the air separation portion at the inlet of the device. When the level drops below the sensors, the AAR Controller software opens the pinch valve. An air purge line is connected from the luer port at the top of the VARD to a blood collection canister. The canister is connected to a regulated wall vacuum source. The air purge line is placed in a mechanical pinch valve on the Performer CPB console. The normal resting position of the pinch valve is closed. When air is detected, the valve is opened to remove the air, then immediately returned to the closed position. The AAR Controller - VARD Run Screen includes the following visual alert and alarm indications and icons representing the status of functional components (see Figure 5-24). 3 2 4 1 5 6 7 8 Figure 5-24. The AAR Controller and VARD Run Screen 1. Press the VARD Call-up button to open the operation of the AAR Controller and VARD. 2. The yellow “Air In VARD” read-only icon appears when the level drops below the first (upper) pair of sensors and: 5-58 A14113002 Rev. 2.0 Operator’s Manual ■ a distinct audible alert tone will sound ■ the system status LED will change to yellow ■ the top line of the message bar will display “AIR IN VARD” ■ The pinch valve will open, allowing wall vacuum to suction the air out of the VARD until the upper pair of ultrasonic sensors detect no remaining air/blood mixture in the upper area of the VARD. ■ The AAR Controller then closes the pinch valve, the yellow Air In VARD icon clears, the audible alert tone ceases, the system status LED returns to green, and “AIR IN VARD” clears from the top line of the message bar. PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use AAR Controller - Venous Air Removal Device (Resting Heart mode only) 3. The red “Too Much Air In VARD” read-only icon appears when the fluid level drops below the second (lower) pair of sensors and: ■ a distinct audible alarm tone will sound ■ the system status LED will change to red ■ the message bar will change to red ■ the top line of the message bar will display “TOO MUCH AIR IN VARD: CHECK VACUUM” ■ Bio-Pump flow reduction may be required until venous air is reduced or eliminated Note: The Bio-Pump flow can be reduced manually or configured to occur automatically by setting the Bio-Pump response to Coast. ■ The pinch valve will open, allowing wall vacuum to suction air out of the VARD until no remaining air/blood mixture is detected by the lower pair of ultrasonic sensors. ■ the red “TOO MUCH AIR IN VARD” icon will change to the yellow “AIR IN VARD” icon ■ the red message bar will clear ■ “TOO MUCH AIR IN VARD: CHECK VACUUM” in the top line of the message bar will change to “AIR IN VARD” ■ the system status LED will change from red to yellow concurrent with the audible alert tone As wall vacuum suctions the remaining air out of the VARD until the ultrasonic sensors detect no remaining air/blood mixture in the upper area of the VARD, the AAR Controller then closes the pinch valve, the yellow “AIR IN VARD” icon clears, the audible alert tone ceases, the system status LED returns to green, and “AIR IN VARD” clears from the top line of the message bar. 4. The Fluid-In-Line (FIL) Sensor read-only icon: ■ ■ Displays when air or fluid is being detected by the ultrasonic sensor downstream from the mechanical pinch valve. In the event excess fluid is being detected by the ultrasonic sensor, the AAR Controller software closes the mechanical pinch valve. 5. The Wall Vacuum Alert read-only icon: ■ ■ Displays the wall vacuum pressure when a vacuum pressure sensor line is connected to the pressure luer port labeled PR7 on the Performer CPB console. ■ The icon will change between gray and red at a default threshold pressure of -200 mm Hg detected at PR7. ■ When the suction is more negative than -200 mm Hg, the icon will be gray. ■ When the suction is less negative than -200 mm Hg, the icon will change to red, indicating a low suction alert, accompanied by a distinct audible alert tone, the system status LED changing to yellow, and the top line of the message bar displaying “VARD: LOW SUCTION.” ■ All alert indications reset automatically when the PR7 pressure becomes more negative than -200 mm Hg. Note: The wall vacuum alert icon is the default display for any pressure monitoring line connected to PR7. Operator’s Manual A14113002 Rev. 2.0 5-59 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 AAR Controller - Venous Air Removal Device (Resting Heart mode only) 6. The Pinch Valve button: ■ The resting position of the mechanical pinch valve is closed as indicated by the green Pinch Valve button. ■ When the green [closed] Pinch Valve button is manually pressed, the mechanical pinch valve opens for 0.5 second. The Pinch Valve button briefly changes to red [open], then automatically reverts back to green [closed]. ■ Displays when the AAR Controller automatically opens and closes the pinch valve. Note: Manually pressing the Pinch Valve button overrides the FIL sensor from detecting fluid in the suction line and from closing the pinch valve. 7. The AAR Controller Mode button indicates the status of the automatic air removal function of the AAR Controller. When in Standby Mode, the system will: ■ detect air in the VARD ■ provide concurrent visual and audible alert or alarm cues ■ NOT command the pinch valve to open and remove air from the VARD If air is detected in the VARD, manually press the Pinch Valve button to remove the air. The pinch valve will open for 0.5 second and then close. Repeat as necessary to clear the air from the VARD. 8. The AAR Controller Mode button indicates the status of the automatic air removal function of the AAR Controller. ■ When in Auto Mode, the system will: ■ detect air in the VARD ■ provide concurrent visual and audible alert or alarm cues ■ command the pinch valve to open automatically to evacuate the air in the VARD ■ After the air in the VARD is removed and the upper pair of sensors detect fluid, the system will command the pinch valve to close automatically. Operation Warning: Do not operate the AAR Controller with equipment other than the Medtronic® Resting Heart™ Module. There are no safety or performance data known to Medtronic that establish compatibility of any other manufacturer's device or component with the Medtronic® AAR Controller. Any substitution of components becomes the responsibility of the user. Such substitution will void Medtronic warranty and the user will bear full responsibility for any adverse consequences stemming from such use. 1. Attach the metal LEMO® connector on the VARD sensor cable to the console. Line up the small red dot on the sensor cable connector with the small red square on the console receptacle. Insert the connector until it “clicks” into place. To remove the cable, grasp the metal collar and pull straight out. Do not pull with the cable itself. 5-60 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use AAR Controller - Venous Air Removal Device (Resting Heart mode only) 2. Attach the plastic LEMO® connector on the VARD sensor cable to the VARD. Line up the arrows on the plastic connector with the raised ridge on the VARD receptacle. Insert the connector until it “clicks” into place. 3. Once the VARD cable is connected and the AAR Controller detects properly functioning ultrasonic sensors in the VARD, the alert “VARD CABLE NOT CONNECTED” will clear from the top line of the message bar. 4. To remove the cable, grasp the plastic collar (but do not squeeze the collar) and pull straight out. Do not pull with the cable itself. Warning: Do not kink the VARD sensor cable. Warning: Do not allow fluids to come into contact with the cable connections. 5. Ensure the VARD is primed. 6. Secure the female luer connector on the pressure line to the PR7 pressure connector on the console. Warning: Do not bypass the fluid isolator/filter in the pressure line for the PR7 pressure connector or fluid could enter the transducer and damage internal components. Operator’s Manual A14113002 Rev. 2.0 5-61 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 AAR Controller - Venous Air Removal Device (Resting Heart mode only) 7f 7a 6 7e 8 7. Ensure that the silicone segment of the VARD purge line is properly seated in the retention clip, pinch valve, and the FIL sensor. a. Press and hold down the mechanical button on the pinch valve. b. Slide the silicone tube into the opening and seat fully into the pinch valve. c. Release the mechanical button. Once the AAR Controller detects tubing in the pinch valve, the alert “VARD: TUBE NOT INSERTED IN PINCH VALVE” will clear. d. Open the tube latch on the FIL sensor. e. Slide the silicone tube in the opening, then close the latch. f. Secure the tube in the retention clip above the pinch valve. 8. Connect the 6.4 mm (1/4 in) ID suction tubing between a wall vacuum regulator and a disposable rigid suction canister. Connect another segment of the 6.4 mm (1/4 in) ID suction tubing between the suction canister and the VARD purge line. 9. Ensure that the vacuum pressure is -200 to -210 mm Hg. Once the PR7 vacuum pressure sensor detects -200 mm Hg, the alert “VARD: LOW SUCTION” clears from the top line of the message bar. The vacuum pressure read-only icon will automatically change from to . Caution: Use a dedicated regulated vacuum source capable of providing 10 L/min of air flow and -210 mm Hg. Caution: Vacuum pressures more negative than -315 mm Hg may cause the FIL sensor to not function properly. Note: Small amounts of air may remain in the top of the VARD after priming and be detected by the upper pair of sensors. The top line of the message bar will display “AIR IN VARD.” 10. Press to manually open the pinch valve . The pinch valve will remain open for 0.5 second and then automatically close. Wall suction will remove the air from the VARD through the VARD purge line. 11. Press to enable the Auto Mode . The alert “VARD: STANDBY MODE” will clear from the top line of the message bar Note: In order to transition from Standby to Auto Mode, a. the VARD cable must be connected between the AAR Controller and the VARD and the alert “VARD CABLE NOT CONNECTED” cleared from the top line of the message bar b. the VARD must be thoroughly primed and free of all air and the alert “AIR IN VARD” cleared from the top line of the message bar 5-62 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Air Detection c. the vacuum pressure detected at PR7 must be more negative than -200 mm Hg, and the alert “VARD: LOW SUCTION” cleared from the top line of the message bar Warning: Do not use the AAR Controller until proper operating conditions are verified. Prior to each use, it is the responsibility of the user to determine that the system is in proper operating condition as described in this manual. Air Detection The Performer CPB accommodates two air bubble detection (ABD) transducers. 1. The ABD transducer for the detection of macro-air in the arterial circuit is integrated into the flow sensing transducer and attaches to a 9.5 mm (3/8 in) x 2.4 mm (3/32 in) segment of tubing in the arterial circuit. It is recommended that the arterial ABD be used on every case. 2. The ABD transducer for the detection of macro-air in the cardioplegia circuit is mounted to the side of the console near the outlet of the cardioplegia pump (PM4). It accommodates 6.4 mm (1/4 in) x 1.2 mm (1/16 in) tubing. Setup and Operation of the Arterial Line ABD System 1. Attach the RS232 connector to the console (see Figure 5-25). The alert “ABD CABLE NOT CONNECTED” will clear from the top line of the message bar. Figure 5-25. RS232 Attachment 2. Attach the transducer to a clean and primed segment of the 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in) arterial line (see Figure 5-26). It is recommended that the transducer be positioned a minimum of 1.2 m (4 ft) from the patient to allow the air detection system sufficient time to respond before air can reach the patient. Operator’s Manual A14113002 Rev. 2.0 5-63 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Air Detection Figure 5-26. Arterial Line Attachment 3. Align the arrow on the transducer with the direction of the flow (see Figure 5-26). 4. For accurate bubble detection, position the sensor so the cable is beneath the tubing. User Interface Setup 2 Resting Heart mode 4 3 Bio-Pump CPB mode Figure 5-27. Air Bubble Detection 1. Press the Safety Systems Configuration button the Safety Systems Edit Screen. from the Main Menu to open Note: The default Bio-Pump and roller pump responses to the ABD detecting arterial air are selected in the Configuration Mode. This screen enables the user to edit these pump responses on a case-by-case basis. When powered off, the system automatically resets to the default settings established in Configuration. 2. Press the right scroll arrow until the event “AIR DETECTED BY ABD” is displayed. 3. Confirm or edit the desired response for the Bio-Pump (Stop, Coast, Message) and the desired response for each roller pump (Stop, Pause, Message, None). 4. Press to return to the Main Menu. 5-64 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Air Detection 1 2 Figure 5-28. Air Bubble Detection 1. To enable the ABD: ■ Ensure the flow sensor with ABD is properly positioned on the arterial line. ■ Turn the Bio-Pump RPM to generate forward flow and ensure flow is registering on the Main Run Screen. ■ Press to enable the ABD. The icon will change to will clear from the top line of the message bar. and the alert “ABD OFF” Note: If the ABD cable is not connected to the console when the ABD icon is pressed, the alert “ABD CABLE NOT CONNECTED” will appear in the message bar. 2. Indicates “AIR DETECTED.” If this occurs during setup, check the connection of the transducer to the tubing or reposition the transducer to a different segment of the 9.5 mm (3/8 in) arterial line. Note: With the ABD properly connected to the console and enabled, verify the performance of the arterial ABD before use. Air Bubble Detection 1 2 Figure 5-29. Air Bubble Detection Operator’s Manual A14113002 Rev. 2.0 5-65 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Air Detection 1. If air is detected during use, ■ the message bar will turn red and the top line will display “AIR DETECTED BY ABD” ■ the “Air Detected” icon will appear ■ the system status LED will change to red ■ audible alarm tones will sound the Bio-Pump RPM will change if the selected pump response is either Stop or Coast per the Configuration Mode or as selected during setup 2. When the Bio-Pump response is set to Stop or Coast, the Main Run Screen will display the Bio-Pump RPM control offset indicator. represents Bio-Pump Coast. ■ ■ the green bar indicates the actual Bio-Pump RPM ■ the red bar indicates the relative position of the Bio-Pump speed RPM knob ■ the bottom line of the message bar displays “BIO-PUMP COAST” represents Bio-Pump Stop ■ the absence of the green bar indicates the Bio-Pump RPM is zero ■ the red bar indicates the relative position of the Bio-Pump speed RPM knob ■ the bottom line of the message bar will display “BIO-PUMP STOP” Note: If two or more events occur to create an alert or alarm, “AIR DETECTED BY ABD” has the highest priority over all other alert, alarm, and servo conditions. To Resume Cardiopulmonary Bypass: Warning: Do NOT press as this will immediately disable the ABD and prevent enabling the ABD until after flow is resumed. 1. Immediately correct the air condition. 2. Press once to temporarily mute the audible alarm tones. ■ the message bar will remain red ■ the system status LED will remain red “AIR DETECTED BY ABD” will remain in top line of the message bar indicates the alarm tones are muted. If the air condition is not corrected and the alarm is not reset within one minute, the alarm tones will resume. 4. Once the air condition is confirmed corrected, press . ■ 3. ■ the red message bar with “AIR DETECTED BY ABD” will clear ■ the red system status LED will clear ■ Confirm that the ABD icon automatically converts to the ABD ENABLED Mode and the message “ABD OFF” is not displayed in the top line of the message bar. ■ If necessary, press the ABD icon until the ABD ENABLED icon appears in the Main Run Screen and “ABD OFF” clears from the top line of the message bar. Note: If the Bio-Pump is in the Coast Mode, the pump RPM will not automatically ramp back up after the ABD sensor is turned off or reset. The user must recapture manual control of the Bio-Pump speed RPM knob and manually resume flow. 5. Recapture manual control of the Bio-Pump speed RPM knob. 5-66 A14113002 Rev. 2.0 Operator’s Manual ■ Rotate the Bio-Pump speed RPM knob counterclockwise. The red bar in the Bio-Pump control offset indicator will move to the left. ■ Manual control of the Bio-Pump is recaptured when the offset indicator disappears. PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Level Sensing System (Bio-Pump CPB mode only) 6. Rotate the Bio-Pump speed RPM knob clockwise to resume flow to the patient. See “Setup and Operation of the Arterial Line ABD System” on page 5-63 for Cardioplegia ABD system information. Level Sensing System (Bio-Pump CPB mode only) Overview The Level Sensing system is a safety device for detecting blood and fluid levels in a reservoir. The Level Sensing System incorporates a pair of color-coded capacitive sensors that are attached to the outside of the reservoir. One sensor is designated as an Alert sensor (yellow); the other sensor is designated as the Alarm sensor (red). Double-sided adhesive tape is used to secure the level sensors to the reservoir surface. The sensors are connected to the Performer CPB console via a single LEMO jack. If the fluid in the reservoir level drops below the position of a level sensor, it will detect the air/fluid level and cause audible and visual cues to be emitted. In the event the fluid level drops below the Alert sensor, the system will automatically generate an audible alert tone, the level detect icon changes to yellow, the System Status LED changes to yellow, and a message appears in the top line of the Message Bar. A red LED on the alert sensor will also illuminate. In the event the fluid level drops below the Alarm sensor, the system will automatically generate an audible alarm tone, the level detect icon changes to red, the System Status LED changes to red, and a message appears in the top line of a red message bar. A red LED on the alarm sensor will also illuminate. The Performer CPB enables the user to link the Level Sensing System to the Bio-Pump control or to a roller pump control and either slow down or stop the pump and prevent further reduction of blood volume in the reservoir. This minimizes the probability of air being transmitted to the patient. Set-up and Operation of the Level Sensing System Warning: The level detection system must be properly set up and enabled prior to clinical use. Undetected emptying of the reservoir may result in gaseous emboli being pumped to the patient with attendant risk of death or serious injury. Warning: Verify the level detection system will function properly with the particular reservoir to be used. Warning: The performance of the level detection system must be verified before each use. User Interface Setup 1. Attach the LEMO connector of the Level Sensor Cable to the Console. Operator’s Manual A14113002 Rev. 2.0 5-67 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Level Sensing System (Bio-Pump CPB mode only) 1 2. Press the Level Sensor Button on the Main Menu. This will open the screen to select the number of level sensor to be used. The level sensors set-up box allows the operator to select using zero, one, or two level sensors. 6 3 4 5 3. The system default is set to “0” level sensors. Once a mode is chosen to use zero, one, or two sensors, the system will retain that selection after the console is powered down. 4. Press the box under the “1” to use only a single level sensor. The green check will appear in the box. ■ The reservoir icon on the Main Run Screen will display one pair of red arrows. The button under the green check will display either ALERT or ALARM. 5. Press to select whether the single sensor will be used as an ALERT sensor or an ALARM sensor. ■ ■ When ALERT is selected, only the yellow ALERT sensor is attached to the reservoir. When only the alert sensor is used and fluid in the reservoir drops below the alert sensor and level sensing is ON, a distinctive audible alert tone sounds, the System Status LED changes to yellow, the status bar on the reservoir icon turns yellow, and the top line of the Message Bar displays LOW BLOOD LEVEL. When ALARM is selected, only the red ALARM sensor is attached to the reservoir. When only the alarm sensor is used and fluid in the reservoir drops below the alarm sensor and level sensing is ON, a distinctive audible alarm tone sounds, the System Status LED changes to Red, the Message Bar changes to red, the status bar on the reservoir icon turns red, and the top line of the Message Bar will display LOW BLOOD LEVEL. 6. Press the box under the “2” to use both the ALERT and the ALARM level sensors. The green check will appear in the box. ■ ■ The reservoir icon in the Main Run Screen will have two pairs of red arrows. ■ The ALERT (yellow) sensor must be positioned above the ALARM (red) sensor. ■ If the Alert sensor is incorrectly positioned below the alarm sensor, the Level Sensor Error Alert (or Alarm, if level sensing is ON) is activated. 7. Press 5-68 A14113002 Rev. 2.0 Operator’s Manual to accept the settings and return to the Main Menu. PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Level Sensing System (Bio-Pump CPB mode only) Note: When the box under the “0” is pressed, the green check will move into the box. The reservoir in the Main Run Screen will have no red arrows. This indicates level Detection is disabled. Select Pump Responses Warning: If the Bio-Pump response for level detection system is configured to not stop the pump or not reduce pump RPM, constant monitoring is required to reduce the risk of emptying the reservoir and transmitting gaseous emboli to the patient. 1. Press to confirm or edit the Bio-Pump and roller pump responses to the LOW BLOOD LEVEL event. A prompt window will open asking “Yes/No” confirmation to the request to change the safety system setting. Indicate “Yes” by pressing the green checkmark. Note: The default Bio-Pump and roller pump responses to low level detection are selected in the Configuration Mode. This screen enables the user to edit these pump responses on a case-by-case basis. When powered off, the system automatically resets to the default settings established in Configuration. 2. Press the right scroll arrow until the ALERT event “LOW BLOOD LEVEL ALERT” is displayed. 3. Confirm or edit the desired response for the Bio-Pump (Coast, Message, None) and the desired response for each roller pump (Stop, Pause, Message, None). 4. Press the right scroll arrow until the ALARM event “LOW BLOOD LEVEL ALARM” is displayed. 5. Confirm or edit the desired response for the Bio-Pump (Stop, Coast, Message, None) and the desired response for each roller pump (Stop, Pause, Message, None). 6. Press to accept the settings and return to the Main Menu. Operator’s Manual A14113002 Rev. 2.0 5-69 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Level Sensing System (Bio-Pump CPB mode only) Sensor Attachment and Preparation for Level Sensing 1. Verify the wall thickness of the reservoir is within the specifications stated in Chapter 3. 2. Attach the level sensor(s) to the outside surface of the reservoir on a flat surface. Ensure the sensor positions are more than 1 cm away from internal structures of the reservoir. ■ Remove one side of the protective strip on the adhesive tape. ■ Adhere to the reservoir surface at the desired level(s). ■ Remove the outer protective strip. ■ Apply the sensor(s) firmly to the adhesive strip with the cable hanging downward and the horizontal line of the cross-line “target” at the desired low level position for alert or alarm. ■ Secure the cable to prevent the sensors from being inadvertently dislodged. Warning: Do not attach sensors over labels. Ensure the ALERT sensor is placed above the ALARM sensor. Warning: Do not place sensors below the minimum operating level recommended by the reservoir manufacturer. Warning: Use the horizontal line of the target as a guide for setting the desired low level position for the alert and alarms sensors. The accuracy of a level sensor to detect changes in fluid level can occur above or below the line within the diameter of the “target.” 3. When the sensors detect fluid: ■ The red arrow(s) on the reservoir icon in the Main Run Screen will change to green . The red LED on the top edge of the level sensor illuminates. 4. Press the level sensor button to enable the level sensing system. ■ 5-70 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Level Sensing System (Bio-Pump CPB mode only) 4 ■ The level detection status bar at the top of the button changes to green. ■ The green arrow(s) will clear. ■ The message LEVEL SENSING DISABLED will clear from the top line of the message bar. ■ The reservoir icon will display a “full” blood level. Note: With the cable properly connected to the console and the level sensor(s) properly attached to the reservoir and the level detection system is ON/ENABLED, verify the performance of the Level Detection system before use. Performance can also be tested with the Level Detection system OFF by looking at the color of the arrows on the icon (red or green). This will not trigger an alarm. Low Level Detection 1. When the level detection system is ON and fluid drops below the yellow sensor, a LOW BLOOD LEVEL alert occurs. ■ A distinctive audible alert tone sounds. ■ The System Status LED changes to yellow. ■ The top line of the Message Bar displays LOW BLOOD LEVEL. ■ The status bar on the level detection button changes to yellow. ■ The blood in the reservoir icon lowers. 2. When the LOW BLOOD LEVEL alert occurs and the Bio-Pump response is set to COAST: ■ The Bio-Pump RPM will change to 2000. ■ The bottom line of the Message Bar will display BIOPUMP COAST. ■ The Main Run Screen will display the Bio-Pump RPM Offset Indicator. ■ The green bar represents the actual Bio-Pump RPM. The red bar represents the relative position of the Bio-Pump speed RPM knob. Operator’s Manual A14113002 Rev. 2.0 5-71 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Level Sensing System (Bio-Pump CPB mode only) 3. While the Bio-Pump is in the COAST mode during a LOW BLOOD LEVEL alert and the fluid level in the reservoir returns above the yellow sensor: ■ The alert tones stop. ■ The display LOW BLOOD LEVEL clears from the top line of the Message Bar. ■ The status bar on the level detection button changes to green. ■ The blood in the reservoir icon raises. ■ The Bio-Pump RPMs ramp back up to the speed that the knob is positioned. Once the Bio-Pump RPM returns to normal, the display BIOPUMP COAST clears from the bottom line of the message bar and the Bio-Pump RPM Offset Indicator clears from the Main Run Screen. 4. When the level detection system is ON and the fluid drops below the red sensor, A LOW BLOOD LEVEL alarm occurs. ■ ■ A distinctive audible alarm tone sounds. ■ The System Status LED changes to red. ■ The Message Bar changes to red. ■ The top line of the Message Bar will display LOW BLOOD LEVEL. ■ The status bar on the level detection button changes to red. ■ The blood in the reservoir icon lowers. 5. Press to mute the alarm. If the reservoir level does not return above the red sensor within one minute, the alarm tones will resume. 6. When the LOW BLOOD LEVEL alarm occurs and the Bio-Pump response is set to COAST: ■ The Bio-Pump RPM will change to 2000. ■ The bottom line of the Message Bar will display BIOPUMP COAST. ■ The Main Run Screen will display the Bio-Pump RPM Offset Indicator. The green bar represents the actual Bio-Pump RPM. The red bar represents the relative position of the Bio-Pump speed RPM knob. 7. While the Bio-Pump is in the COAST mode during a LOW BLOOD LEVEL alarm and the fluid level in the reservoir returns above the red sensor: a. For a two sensor configuration and the fluid level is above the red sensor and is still below the yellow sensor: ■ 5-72 A14113002 Rev. 2.0 Operator’s Manual ■ The audible alarm tones change to the audible alert tones. ■ System Status LED changes from red to yellow. ■ The red Message Bar clears. ■ The top line of the Message Bar displays LOW BLOOD LEVEL. ■ The status bar on the level detection button changes from red to yellow. ■ The fluid level in the reservoir icon rises. ■ The Bio-Pump RPMs ramp back up to the speed that the knob is positioned. ■ Once the Bio-Pump RPM returns to normal, the display BIOPUMP COAST clears from the bottom line of the message bar and the Bio-Pump RPM Offset Indicator clears. PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use AutoClamp System (Bio-Pump CPB mode only) b. For a one sensor “alarm only” configuration and the fluid level is above the red sensor: ■ The audible alarms tones cease. ■ The System Status LED changes from red to green. ■ The red Message Bar clears. ■ The display LOW BLOOD LEVEL clears from the top line of the Message Bar. ■ The status bar on the level detection button changes from red to green. ■ The Bio-Pump RPMs ramp back up to the speed that the knob is positioned. Once the Bio-Pump RPM returns to normal, the display BIOPUMP COAST clears from the bottom line of the Message Bar and the Bio-Pump RPM Offset indicator clears. 8. When the LOW BLOOD LEVEL alarm occurs and the Bio-Pump response is set to STOP: ■ ■ The Bio-Pump RPM will change to zero. ■ The bottom line of the Message Bar will display BIOPUMP STOP. ■ The Main Run Screen will display the Bio-Pump RPM Offset Indicator. The absence of the green bar represents the actual Bio-Pump RPM is zero. The red bar represents the relative position of the Bio-Pump speed RPM knob. 9. While the Bio-Pump is in the STOP mode during a LOW BLOOD LEVEL alarm and the fluid level in the reservoir returns above the red sensor, the user must manually restart the Bio-Pump. a. Turn the Bio-Pump Control Knob fully counterclockwise to the full “OFF” position. The Bio-Pump RPM Offset Indicator will clear. b. Turn the control knob clockwise to increase RPM and resume arterial flow. c. Closely monitor the level in the venous reservoir. ■ AutoClamp System (Bio-Pump CPB mode only) Overview The Performer CPB incorporates an optional AutoClamp System to be placed on the arterial line when using a Centrifugal pump as the arterial pump. When the Bio-Pump run mode changes (STOP, COAST, LOW FLOW) there exists the potential for blood to flow retrograde through the arterial line from the aortic cannula into the venous reservoir. This "backflow" may cause entrainment of air into the arterial line from around the aortic cannulation site. If unrecognized when forward flow is resumed, air may be introduced into the aorta. Placing a pneumatically powered tube clamp on the arterial line serves to prevent retrograde flow and thereby prevent the potential to entrain air around the aortic cannulation site. Operator’s Manual A14113002 Rev. 2.0 5-73 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 AutoClamp System (Bio-Pump CPB mode only) The system is comprised of a Remote Tube Clamp, an AutoClamp Interface Module and an Oxygen-Air Blender. The device utilizes the hospital compressed air source to operate the AutoClamp System. The Interface Module mounted on the back of the console houses the gas regulator, pressure sensor and gas switches for applying and releasing compressed air for opening and closing the Remote Tube Clamp. Compressed air applied to the Remote Tube Clamp keeps it in the OPEN position. When the AutoClamp System is configured by the user to CLOSE in response to a Bio-Pump Event (STOP, COAST, LOW FLOW, BACKFLOW), the Interface Module releases gas pressure to the Remote Tube Clamp allowing it to close. Once the Bio-Pump Event has been corrected, a button on the Central Information Display allows the user to resume the clamp OPEN position. When the Bio-Pump run mode changes to COAST, the Bio-Pump motor speed controller automatically reduces the Bio-Pump RPM to 2000. When the user manually reduces the Bio-Pump speed with the knob, the position of the “detent” is approximately 2000 RPM. Because of differences in patient arterial pressure, height differences between the patient and the venous reservoir, and the use of Vacuum Assisted venous Drainage, there exists the potential for either forward flow or arterial backflow when the Bio-Pump is at or near 2000 RPM. The Performer CPB includes the user-selectable option to configure the Remote Tube Clamp to CLOSE in response to BIO-PUMP COAST to prevent the potential for arterial backflow. Warning: Prior to selecting the Remote Tube Clamp response when the Bio-Pump enters the COAST mode, it is the user's responsibility to test their extracorporeal circuit and confirm the conduct of perfusion at their institution does not generate arterial backflow when the Bio-Pump enters the COAST mode or the Bio-Pump speed is manually reduced to the “detent” position. Warning: If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY ABD” alarm, pump RPM will remain at 2000 and will not automatically ramp up after the air is no longer detected by the ABD or after the ABD is turned off. Flow can only be resumed manually after careful assurance that air has been completely removed from the arterial circuit. Warning: If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY ABD” alarm and the Remote Tube Clamp is configured to CLOSE, the Remote Tube Clamp will not automatically OPEN after Bio-Pump flow is resumed. The user must manually press the AutoClamp button on the Main Run Screen to open the clamp after careful assurance there will be forward flow. Caution: If the pressurized gas fails, the air hose is disconnected, or the AutoClamp Interface Module communication cable becomes disconnected, the clamp closes. 5-74 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use AutoClamp System (Bio-Pump CPB mode only) System Set-up 1. Slide the Remote Tube Clamp (RTC) onto the mount adapter and tighten the set-screw on the adapter. 2. Mount the bracket onto the pole on the Performer CPB. 3. Attach the RTC with mount adapter to the bracket using the pin. 1 2 3 3 4. Secure the AutoClamp Interface (ACI) Module to the back of the Performer CPB. 5. Connect the compressed air line and the communication cable from the RTC to the ACI Module. 4 5 6. Attach the compressed air T-adapter to the air inlet gas fitting of the Oxygen-Air Blender, between the blender and the water trap. 7. Attach the appropriate gas supply line from the blender T-adapter to the Gas IN connection on the right side of the ACI Module. 6 7 Operator’s Manual A14113002 Rev. 2.0 5-75 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 AutoClamp System (Bio-Pump CPB mode only) 7 8. Connect the communications cable to the ACI Module and the appropriate LEMO jack on the External Devices Connector Panel. 8 Note: Ensure that the compressed air pressure is within the specifications in Chapter 3. User Interface Set-up 1. 2. 3. 4. From the Home Screen, press SYSTEM CONFIGURATION and enter password. Press to enter the User Preferences Screen. Scroll right to MISCELLANEOUS. To enable the AutoClamp, press the box under “1” in the AUTOCLAMP window. The green check will move to that box to indicate the AutoClamp feature is enabled. 5. Press to configure the AutoClamp response to Bio-Pump Events. 6. Press the right scroll arrow to view the following events relevant to closing the AutoClamp. 5-76 A14113002 Rev. 2.0 Operator’s Manual ■ BIOPUMP STOP ■ BIOPUMP COAST ■ BIOPUMP BACKFLOW ■ BIOPUMP LOW FLOW PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use AutoClamp System (Bio-Pump CPB mode only) Note: The events listed above are the only events the user can configure to have the AutoClamp close. 7. Press to return to the Home Screen. A window will appear requesting to: – Save changes – Save as New Profile – Exit Without Saving 8. Press SAVE CHANGES. The Home Screen will appear. 9. Press BIO-PUMP CPB to open the operations screen. A yellow icon for the AutoClamp will appear in the Main Run Screen . Prepare AutoClamp for Use The status of the AutoClamp (Self test, ON, OFF) is controlled using buttons on the Main Run Screen. Displayed when the operations screen is first opened. The AutoClamp is OFF and the clamp is OPEN. Press to initiate the Self Test. Displayed when the AutoClamp is OFF and the clamp is OPEN. Press to turn ON the AutoClamp. Displayed when the AutoClamp is ON and the clamp is OPEN. Press to turn OFF the AutoClamp. Displayed when the Arterial AutoClamp has been activated and the clamp is CLOSED. Press to turn OFF the AutoClamp and OPEN the Remote Tube Clamp. 1. Ensure the AutoClamp System gas lines and communication cables are properly connected between the ACI Module, blender and RTC. 2. Connect the compressed air and oxygen gas lines from the Oxygen-Air Blender to the appropriate compressed air and oxygen sources. When gas pressure is applied to the ACI Module, the RTC will automatically open and enable loading of tubing. Gas pressure keeps the clamp open. Note: If the gas pressure to the ACI Module is low, the top line of the Message Bar will display AUTOCLAMP PRESSURE LOW. 3. The AutoClamp button on the Main Run Screen is yellow. Note: The button remains yellow until (1) the AutoClamp Self Test is initiated or (2) the Pump Timer is started. If the Pump Timer is started, the button turns Gray + Red X. 4. Load the RTC with a primed segment of the arterial line tubing that is distal from the arterial filter. The RTC accommodates 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in) wall thickness tubing only. Operator’s Manual A14113002 Rev. 2.0 5-77 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 AutoClamp System (Bio-Pump CPB mode only) a b c a. Sufficiently loosen the knob to swing the security latch down. b. Lift the door and insert the tubing, then close the door. c. Swing the security latch in place and tighten the knob. Perform AutoClamp Self Test Warning: The AutoClamp Self Test must be performed prior to each use of the device. If the AutoClamp System does not operate as described during the Self Test, do not use the AutoClamp System. Contact Medtronic Service. 1. Ensure a primed segment of the arterial line distal from the arterial filter is properly loaded in the RTC. 2. Ensure the ultrasonic flow sensor is properly attached to the arterial line. 3. Ensure the arterial filter purge line and sampling manifold stopcocks are closed. 4. Ensure sufficient gas pressure is supplied to the ACI Module (refer to the specifications on page 3-6). Note: If there is insufficient gas pressure, the top line of the Message Bar will display AUTOCLAMP PRESSURE LOW and prevent the Self Test from occurring. 5. Turn on the Bio-Pump, set the RPM > 2000 and generate flow. 6. Press on the Main Run Screen to initiate the SELF TEST. ■ The yellow AutoClamp button will flash. ■ The top line of the Message Bar displays AUTOCLAMP SELF TEST RUNNING. ■ The AutoClamp closes for 5 seconds. ■ The system looks for the flow reading to register 0.00 L/min. ■ If after 5 seconds the flow registers 0.00 L/min, the AutoClamp opens and the button changes to . The display AUTOCLAMP SELF TEST RUNNING clears from the top line of the Message Bar. SELF TEST PASSED will be entered in the Log Screen. If the flow does not display 0.00 L/min before 5 seconds, the AutoClamp opens and the display AUTOCLAMP SELF TEST FAILED appears in the top line of the Message Bar and the Log Screen. The button remains yellow. 5-78 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use AutoClamp System (Bio-Pump CPB mode only) 7. The Self Test Fails if: ■ The RTC does not open at the beginning of the test. This is done to check any problem unrelated to the ACI Module. The top line of the Message bar will display AUTOCLAMP SELF TEST FAILED. The Events Log will display AUTOCLAMP NOT OPENED. ■ The RTC does not close. The top line of the Message bar will display AUTOCLAMP SELF TEST FAILED. The Events Log will display AUTOCLAMP NOT CLOSED. The Bio-Pump flow is > 0.00 after 5 seconds. The top line of the Message Bar will display AUTOCLAMP SELF TEST FAILED. 8. If the Self Test fails, the yellow button remains. The Self Test can be repeated. Ensure a primed segment of the arterial line distal from the arterial filter is properly positioned in the RTC and the security latch is tightened. 9. When the Self Test passes: ■ ■ The system will enter AUTOCLAMP SELF TEST PASSED into the Log Screen. The RTC opens and the AutoClamp button turns to 10. Press to open the Safety System Edit Screen. ■ . Note: The Arterial AutoClamp responses (CLOSE or NONE) are selected in the Configuration Mode. This screen enables the user to edit these AutoClamp responses on a case-by-case basis. When powered off, the system automatically resets to the default settings established in Configuration. 11. Press the right scroll arrow to view the following events: ■ BIOPUMP STOP ■ BIOPUMP COAST ■ BIOPUMP BACKFLOW BIOPUMP LOW FLOW 12. Confirm or edit the desired response for the AutoClamp (CLOSE, NONE) for these events. 13. Press to return to the Main Menu. ■ Operation of the AutoClamp System The Bio-Pump can be configured to AUTOMATICALLY change its speed (STOP or COAST) in response to safety systems being activated (AIR DETECTED BY ABD, LOW BLOOD LEVEL, ALP OVERPRESSURE). The AutoClamp setting can be configured to CLOSE when the Bio-Pump speed automatically changes to the STOP mode. In doing so, the AutoClamp will also CLOSE when the Bio-Pump knob is turned fully counterclockwise and manually turned off. The AutoClamp setting can be configured to CLOSE when the Bio-Pump speed automatically changes to the COAST mode. In doing so, the AutoClamp will also CLOSE when the Bio-Pump speed is manually reduced to 2000 RPM. Operator’s Manual A14113002 Rev. 2.0 5-79 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 AutoClamp System (Bio-Pump CPB mode only) 5-80 A14113002 Rev. 2.0 User-configured Bio-Pump Event Description of AutoClamp Function BIOPUMP STOP (AUTOMATIC) If the AutoClamp is configured to CLOSE when the Bio-Pump automatically stops: ■ RPMs automatically go to zero and the RTC closes. ■ The Bio-Pump RPM Offset Indicator appears. ■ The AutoClamp button on the Main Run Screen changes to red . ■ Audible alarm tones sound. ■ The System Status LED changes to red. ■ The bottom line of the red Message Bar displays AUTOCLAMP CLOSED BIO-PUMP STOP. Warning: Resume flow only after careful assurance there is no air in the arterial circuit. To Open the AutoClamp and resume flow: ■ Press to mute the Alarm. ■ Correct the condition that caused the BIOPUMP STOP event. ■ Press the Check button . ■ Turn the Bio-Pump RPM fully counterclockwise. The Bio-Pump RPM Offset Indicator clears. ■ Turn the Bio-Pump RPM > 2200. ■ Press the red AutoClamp button. The button changes to . The RTC will open and forward flow will resume. ■ The top line of the Message Bar will display AUTOCLAMP OFF. ■ Once flow is stabilized, press the Gray + Red “X” button to enable the AutoClamp. The display AUTOCLAMP OFF will clear from the top line of the Message Bar. ■ The System Status LED will change to Green. BIOPUMP STOP (MANUAL) If the AutoClamp is configured to CLOSE to the event BIO-PUMP STOP and the Bio-Pump knob is manually turned fully counterclockwise to the STOP position: ■ The RTC automatically closes. ■ The AutoClamp button on the Main Run Screen changes to red . ■ The bottom line of the red Message Bar displays AUTOCLAMP CLOSED. Warning: Resume flow only after careful assurance there is no air in the arterial circuit. To Open the AutoClamp and resume flow: ■ Turn the Bio-Pump RPM > 2200. ■ Press the red AutoClamp button. The button changes to . The RTC will open and forward flow will resume. ■ The top line of the Message Bar will display AUTOCLAMP OFF and the System Status LED will change to yellow. ■ Once flow is stabilized, press the Gray + Red “X” button to enable the AutoClamp. The display AUTOCLAMP OFF clears from the top line of the Message Bar and the System Status LED changes to Green. Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use AutoClamp System (Bio-Pump CPB mode only) User-configured Bio-Pump Event Description of AutoClamp Function BIOPUMP COAST (AUTOMATIC) When the AutoClamp is configured to CLOSE when the Bio-Pump automatically enters the COAST mode: ■ RPMs automatically go to 2000 and the RTC closes. ■ The Bio-Pump RPM Offset Indicator appears. ■ The AutoClamp button on the Main Run Screen changes to red . ■ Audible alert tones sound. ■ The System Status LED changes to yellow. ■ The bottom line of the red Message Bar displays AUTOCLAMP CLOSED BIO-PUMP COAST. Warning: If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY ABD” alarm, pump RPM will remain at 2000 and will not automatically ramp up after the air is no longer detected by the ABD or after the ABD is turned off. Flow can only be resumed manually after careful assurance that air has been completely removed from the arterial circuit. When the condition is corrected that caused the BIOPUMP COAST event: ■ The RPMs automatically ramp back up. ■ When the RPMs reach 2200, the RTC automatically opens. ■ The display AUTOCLAMP CLOSED clears from the bottom line of the Message Bar. ■ The AutoClamp button automatically changes to . ■ When the RPMs have returned to normal, the Bio-Pump RPM Offset Indicator clears, the System Status LED changes to green and the display BIOPUMP COAST clears from the bottom line of the Message Bar. BIOPUMP COAST (MANUAL) If the AutoClamp is configured to CLOSE to the event BIO-PUMP COAST and the Bio-Pump knob is manually turned clockwise to 2000 RPM or below: ■ The RTC automatically closes. ■ The AutoClamp button on the Main Run Screen changes to red . ■ The bottom line of the red Message Bar displays AUTOCLAMP CLOSED Warning: Resume flow only after careful assurance there is no air in the arterial circuit. To Open the AutoClamp and resume flow: ■ Turn the Bio-Pump RPM > 2200. The RTC automatically opens. ■ The red AutoClamp button changes to . ■ The display AUTOCLAMP CLOSED clears from the bottom line of the Message Bar. Operator’s Manual A14113002 Rev. 2.0 5-81 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 AutoClamp System (Bio-Pump CPB mode only) Manual reduction in Bio-Pump speed can result in the RPM’s being too low to overcome resistance in the arterial line and maintain forward flow. This can result in a negative, or retrograde flow through the arterial line detected by the ultrasonic arterial flow sensor. The AutoClamp setting can be configured to CLOSE when the Bio-Pump speed is manually changed that results in a negative, or retrograde arterial flow. 5-82 A14113002 Rev. 2.0 User-configured Bio-Pump Event Description of AutoClamp Function BIOPUMP BACKFLOW When the AutoClamp is configured to CLOSE when the ultrasonic arterial flow sensor detects backflow: ■ The RTC automatically closes. ■ The AutoClamp button on the Main Run Screen changes to red . ■ Audible alert tones sound. ■ The System Status LED Changes to yellow. ■ The top line of the Message Bar displays BIOPUMP BACKFLOW. ■ The bottom line of the Message Bar displays AUTOCLAMP CLOSED. Immediately correct the condition(s) that created the BIOPUMP BACKFLOW event. Warning: Resume flow only after careful assurance there is no air in the arterial circuit. To resume forward flow, turn the Bio-Pump RPM control knob clockwise. Once the Bio-Pump RPM > 2200: ■ Press the red AutoClamp button. The RTC will immediately open to resume forward flow. ■ The display AUTOCLAMP CLOSED clears from the bottom line of the Message Bar. ■ The red AutoClamp button changes to gray and the top line of the Message Bar will display AUTOCLAMP OFF. ■ Press the Gray AutoClamp button to turn the AutoClamp to ON. The button changes to green and the display AUTOCLAMP OFF clears from the top line of the Message Bar. ■ The alert tones stop. ■ The System Status LED changes to green. Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use AutoClamp System (Bio-Pump CPB mode only) Manual reduction in Bio-Pump speed can result in the flow dropping below a user-defined low flow limit and create a BIOPUMP LOW FLOW event. The AutoClamp setting can be configured to CLOSE when the Bio-Pump speed is manually changed that results in the flow reaching the BIOPUMP LOW FLOW limit setting. User-configured Bio-Pump Event Description of AutoClamp Function BIOPUMP LOW FLOW See page 5-94 to set the Bio-Pump Low Flow Limit. When the AutoClamp is configured to CLOSE when the ultrasonic flow sensor detects the LOW FLOW limit: ■ The RTC automatically closes. ■ The AutoClamp button on the Main Run Screen changes to red . ■ Audible alert tones sound. ■ The System Status LED Changes to yellow. ■ The top line of the Message Bar displays BIOPUMP LOW FLOW. ■ The bottom line of the Message Bar displays AUTOCLAMP CLOSED. Immediately correct the condition that caused the BIO-PUMP LOW FLOW event. Warning: Resume flow only after careful assurance there is no air in the arterial circuit. To resume forward flow, turn the Bio-Pump RPM control knob clockwise. Once the Bio-Pump RPM > 2200: ■ Press the red AutoClamp button. The RTC will immediately open and enable forward flow. ■ The display AUTOCLAMP CLOSED clears from the bottom line of the Message Bar. ■ The red AutoClamp button changes to gray and the top line of the Message Bar will display AUTOCLAMP OFF. ■ Press the Gray AutoClamp button to turn the AutoClamp to ON. The button changes to green and the display AUTOCLAMP OFF clears from the top line of the Message Bar. ■ The alert tones stop. ■ The System Status LED changes to green. Operator’s Manual A14113002 Rev. 2.0 5-83 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Pressure Mode Selection Pressure Mode Selection The Performer CPB accommodates eight (8) pressure monitoring locations. The system will measure pressures between -250 mm Hg and +750 mm Hg. All pressure monitoring transducers are located inside the console. Each transducer has an external metal male luer connector permanently mounted on the console. These luer connectors accommodate the attachment of disposable pressure monitoring sets between the extracorporeal circuit and the pressure monitoring transducer. Warning: Only pressure monitoring sets that incorporate an air-fluid pressure isolator may be used with the Performer CPB pressure monitoring system. The Performer CPB allows for the input of user-selectable pressure limit values and input of the pump responses when the pressure limits are reached. Pressure safety limits with their concomitant pump responses are typically defined as alert limits and alarm limits. Alert limits typically serve to elevate the user's awareness of changing line pressure conditions. Alarm limits typically serve to warn the user of high pressure situations and incorporate an automatic pump response to prevent the high pressure from creating a catastrophic event. The factory default alert and alarm pressure limits and the pump responses for the Resting Heart mode are listed as follows: 5-84 A14113002 Rev. 2.0 PUMP AFFECTED ALERT LIMIT (mm Hg) PUMP RESPONSE ALARM LIMIT (mm Hg) PUMP RESPONSE PR-1 PM1 200 MESSAGE 300 PAUSE PR-2 PM2 200 MESSAGE 300 PAUSE PR-3 PM3 200 MESSAGE 300 PAUSE PR-4 (Cardioplegia) PM4 200 MESSAGE 300 PAUSE PR-5 (VLP) BIO-PUMP -100 MESSAGE -200 COAST PR-6 (ALP) BIO-PUMP 200 MESSAGE 300 COAST PR-7 (VARD) NONE 200 MESSAGE -500 MESSAGE PR-8 NONE 200 MESSAGE 300 MESSAGE Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Pressure Mode Selection The factory default alert and alarm pressure limits and the pump responses for the Bio-Pump CPB mode are listed as follows: PUMP AFFECTED ALERT LIMIT (mm Hg) PUMP RESPONSE ALARM LIMIT (mm Hg) PUMP RESPONSE PR-1 PM1 200 MESSAGE 300 PAUSE PR-2 PM2 200 MESSAGE 300 PAUSE PR-3 PM3 200 MESSAGE 300 PAUSE PR-4 (Cardioplegia) PM4 200 MESSAGE 300 PAUSE NONE 200 MESSAGE 300 MESSAGE BIO-PUMP 200 MESSAGE 300 COAST PR-7 NONE 200 MESSAGE 300 MESSAGE PR-8 NONE 200 MESSAGE 300 MESSAGE PR-5 PR-6 (ALP) Note: The factory default alert and alarm pressure limits can be edited before and during each case. All edits are saved when the Home button is pressed or the system is powered off. Editing Pressure Limits for the Current Case Only Arterial and Venous Line Pressure Limit Settings 3 Resting Heart Mode Bio-Pump CPB Mode Figure 5-30. Arterial and Venous Line Pressure Limit Settings 1. Resting Heart: Press from the Main Menu to display the pressure limits for the arterial line (ALP) and the venous line (VLP) alert limits (blue) and alarm limits (red). 2. Bio-Pump CPB: Press from the Main Menu to display the pressure limits for the arterial line (ALP) alert limits (blue) and alarm limits (red). 3. Press the button displaying the pressure limit to be changed. A Pressure pop-up window will appear. Operator’s Manual A14113002 Rev. 2.0 5-85 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Pressure Mode Selection 4 4. Press the Up/Down arrows until the desired pressure value is displayed. The system will accept either positive or negative values. Press the edited value to accept the value. If the new value is not confirmed, the pressure limit will revert back to the old value and the pop-up window will clear. 5. Press to return to the Main Menu. Roller Pump Pressure Channel Limit Settings 2 3 6 4 Figure 5-31. Roller Pump Pressure Channel Limit Settings 1. Press from the Main Menu to display the pressure limits for roller pump pressure channels (PR1, PR2, PR3 and PR4). Notes: PR1 is the dedicated pressure channel for roller pump PM1. PR2 is the dedicated pressure channel for roller pump PM2. PR3 is the dedicated pressure channel for roller pump PM3. PR4 is the dedicated pressure channel for PM4 (cardioplegia pump). 2. Press to select the desired roller pump to confirm or edit the pressure limit settings. 3. Press the button for the pressure limit to be edited. The Pressure pop-up window will appear. 4. Press the Up/Down arrows until the desired pressure value is displayed. The system will accept either positive or negative values. Press the edited value to accept the value. If the new value is not confirmed, the pressure limit will revert back to the old value and the pop-up window will clear. 5. Press to return to the Main Menu. 6. Not yet implemented. Caution: When the system returns to the Home Screen: 5-86 A14113002 Rev. 2.0 Operator’s Manual ■ Edits to pressure limits are stored in the active User Profile ■ Edits to pump responses (and in general all the Safety Systems settings) are reset to the values of the active User Profile. PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Pressure Mode Selection Zeroing the Pressure Transducers 2 3 Figure 5-32. Pressure Parameters Screen 1. Press to open the Parameters Screens. 2. Use the scroll arrows to select PRESSURES [MMHG]. 3. Ensure that the pressure luer ports are open to atmosphere. Press to zero the transducers. The value in the displays will read 0 mm Hg. 4. Press to close the Parameters Screen and return to the Main Menu. Alert Limit The alert limit should be set to warn of slowly changing conditions that may raise the average pressure significantly, such as a cannula misalignment or increased systemic resistance. When the pressure exceeds an alert limit: ■ the system status LED illuminates yellow ■ a distinct audible alert tone sounds ■ the top line of the message bar displays the pressure limit that was exceeded (ALP Overpressure Alert, CPG Overpressure Alert, etc) ■ pump speed(s) may change depending on the factory default pump responses or changes made during editing Correct the high pressure condition. When the pressure drops below the alert limit, the alert indicators will clear automatically. Start the pump(s) if configured to stop for an alert condition. Alarm Limit The alarm limit should be set to warn of either instantaneous high pressure situations that may rupture a tubing circuit (cardioplegia circuit) or when other line pressures exceed otherwise normal clinically acceptable limits (restriction in the Bio-Pump circuit). When the pressure exceeds the user-defined alarm limit: ■ The System Status LED changes to red ■ Distinct audible alarm tones sound ■ The message bar changes to red ■ The top line displays the pressure channel that was exceeded (ALP Overpressure Alarm, CPG Overpressure Alarm, etc) ■ The appropriate pressure pop-up window will appear ■ Pump speed(s) may change depending on the factory default pump responses, configuration settings, or changes made during editing. If the pump response is set to Stop, Coast (Bio-Pump), or Pause (Roller Pump): ■ The pressure will drop below the alarm limit and the alarm indicators will clear automatically Operator’s Manual A14113002 Rev. 2.0 5-87 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Pressure Mode Selection ■ The pressure pop-up window will remain visible User Intervention 1. Correct the high pressure condition. 2. If necessary, reset the value for the pressure limit using the pressure pop-up window and confirm the new pressure limit value. 3. Start the pump(s) if configured to Stop for an alarm condition. Pressure Monitoring Sets with Air/Fluid Isolators Setup Warning: A fluid isolator is necessary in the pressure monitoring line to prevent contact of sterile fluid path with the instrument and damage to the instrument and pressure system. 1. Prime the pressure monitoring set. (Instructions for priming are included with the pressure monitoring set.) 2. Ensure there is no flow going through the circuit and there is no pressure transmitted to the monitoring set. 3. For monitoring positive pressure circuits (arterial line, cardioplegia), prime the isolator dome so the diaphragm is displaced towards the extracorporeal circuit; the dome should be predominantly air-filled. Close the stopcock between the isolator dome and the circuit. Figure 5-33. Isolator Dome For Positive Pressure Circuits 4. For monitoring negative pressure circuits (venous line, LV vent), prime the isolator dome so the diaphragm is displaced away from the circuit; the dome should be predominantly fluid-filled. Close the stopcock between the isolator dome and the circuit. Figure 5-34. Isolator Dome For Negative Pressure Circuits Note: A diaphragm in the isolator dome that becomes fully deflected away from the metal luer fitting during use (negative pressure circuits) or fully deflected towards the metal luer fitting during use (positive pressure circuits) indicates an air leak in the pressure transducer system. Check to insure the female luer is securely fitted to the metal luer fitting on the console. If the leak persists, contact a Medtronic service representative. 5. Ensure the transducers are properly zeroed. 5-88 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Pressure Mode Selection 6. Connect the female luer connector(s) of the pressure monitoring set to the appropriate transducer luer connector on the console. 7. Open the stopcock between the isolator dome and the circuit. 8. Ensure every pressure monitoring system is functioning properly prior to use. Pressure Monitoring The windows on the Main Run Screen for arterial line pressure and the venous line pressure accommodate displaying the systolic, diastolic, mean, and instantaneous pressures. Changes can be made during use. 1 1 Resting Heart Main Run Screen 2 3 Bio-Pump CPB Main Run Screen 4 5 Operator’s Manual A14113002 Rev. 2.0 5-89 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Venous Saturation and Hematocrit Monitoring Figure 5-35. Various Pressure Displays 1. Press to scroll through the arterial values (systolic pressure, mean pressure, diastolic pressure, and instantaneous pressure). (Note the changes in the sine wave icon.) 2. Systolic Pressure 3. Mean Pressure 4. Diastolic Pressure 5. Instantaneous Pressure Venous Saturation and Hematocrit Monitoring 1. Identify the Saturation/Hematocrit (O2 Sat/Hct) cable with the sensor and the Hematocrit-Temperature-Saturation (HTS) Module located on the back of the console. 2. Connect the sensor cable to the HTS Module. O2 Sat/Hct 3. Snap the sensor to the disposable cuvette in the perfusion circuit. 5-90 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Venous Saturation and Hematocrit Monitoring 4. Detection and display of the hematocrit (Hct) and venous saturation (OXYGEN SAT) occur automatically and are displayed on the Main Run Screen. No prebypass calibration or in-vitro recalibration are required. Caution: The oxygen saturation and hematocrit monitoring system is not intended to substitute for regular patient observation and laboratory testing. Prior to any therapeutic treatment, the oxygen saturation and hematocrit should be determined by laboratory methods. Set the Low Hematocrit (HEMATOCRIT) Alert 1 Resting Heart Main Run Screen 1 Bio-Pump CPB Main Run Screen 1. Press the HCT button on the Main Run Screen. The HCT pop-up window will appear. 2. Press the Up/Down arrows until the desired low HCT alert value is displayed. 3. Press the edited value to accept the value. If the new value is not confirmed, the low HCT value will revert back to the old value and the pop-up window will clear. 4. If the Hematocrit falls below the alert value, the System Status LED will change to yellow, an audible alert tone sounds, and the top line of the Message Bar displays HEMATOCRIT: LOW VALUE. Set the Low Oxygen Saturation (OXYGEN SAT) Alert 1. Press the OXYGEN SAT button on the Main Run Screen. The OXYGEN SAT pop-up window will appear. 2. Press the Up/Down arrows until the desired low OXYGEN SAT alert value is displayed. 3. Press the edited value to accept the value. If the new value is not confirmed, the low OXYGEN SAT alert will revert back to the old value and the pop-up window will clear. 4. If the Oxygen Saturation falls below the alert value, the System Status LED will change to yellow, an audible alert tone sounds, and the top line of the Message Bar displays OXYGEN SATURATION: LOW VALUE. Operator’s Manual A14113002 Rev. 2.0 5-91 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Venous Saturation and Hematocrit Monitoring In-Vivo Offset Adjustment for Venous Saturation and Hematocrit The SAT/HCT software allows the user to adjust none, one or both of the displayed values to match values obtained from laboratory analysis. Note: When the Offset feature is used, the venous blood sample should be drawn when patient hemodynamics are stable. More than one lab sample should be considered before making an Offset adjustment. Laboratory analysis should provide measured values for SAT and HCT. 1. When the blood sample has been taken, press the SAT/HCT Offset Button the Main Menu to store the current HCT and OXYGEN SAT values. in 2 3 2 Resting Heart mode Bio-Pump CPB mode 2. The SAT/HCT Offset Button changes to two independent Recall buttons and the Stored icon is added to both the Hematocrit and Oxygen Sat. boxes. 3. If the results from the lab sample warrant adjusting the HCT Offset, press the HCT Recall button to change the value. 4 4. A Pop-Up window will appear. Press the appropriate Up/Down buttons to modify the value to match the lab results. 5 5. Press the HCT value to confirm the new value. The Confirmation Window will appear when pressed within 10 seconds of modifying the value. 5-92 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Venous Saturation and Hematocrit Monitoring 7 6 6. Press to cancel the new value. The confirmation window and HCT pop-up window will disappear. 7. Press to confirm the new value. 10 8 9 Resting Heart mode Bio-Pump CPB mode 8. After confirming the new value, the HCT recall button becomes grey and is not selectable. 9. The Stored icon is deleted indicating the HCT value has been updated. Note: If the user does not confirm the new value (by pressing the upper box) within 10 seconds as instructed in step 5: a. The pop-up window disappears. b. The HCT recall button remains colored and is still selectable. c. The Stored icon is not deleted. Therefore, no offset has applied to the stored value. Repeat steps 3, 4, 5, and 7 to ensure the new (offset) value obtained from the lab sample is properly entered into the system. 10. If the results from the lab sample warrant adjusting the O2 SAT Offset, press the O2 SAT Recall button and continue as in steps 4 through 7 to change the value. 11 12 Resting Heart mode Bio-Pump CPB mode Operator’s Manual A14113002 Rev. 2.0 5-93 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Options Menu Screen 11. After both the values (HCT and SAT) have been modified and confirmed, the SAT/HCT Offset Button replaces the Recall button. The procedure can be restarted. 12. The Stored icon for SAT is also deleted and the value is updated. Note: When the system returns to the home screen or is powered down, the SAT and HCT offset values will be removed. Options Menu Screen Bio-Pump 5 7 2 Resting Heart Mode 4 Bio-Pump CPB Mode Figure 5-36. Bio-Pump Screens 1. Press from the Main Menu to confirm or edit the following: ■ the low flow limit (in L/min) ■ alert and alarm pressure limits for venous line (VLP) (Resting Heart mode only) ■ alert and alarm pressure limits for the arterial line (ALP) Bio-Pump responses (Stop, Coast, Message, None) when the above Safety Limits are exceeded 2. Press the button displaying the pressure value to be edited (ALP alert or alarm pressure limits and/or VLP alert or alarm pressure limits). The corresponding Pressure pop-up window will appear. ■ 3. Press the Up/Down arrows until the desired pressure value is displayed. The system will accept either positive or negative values. Press the edited value to accept the value. If the new value is not confirmed, the pressure limit will revert back to the old value and the pop-up window will clear. 4. Press the response button to edit the Bio-Pump response to the VLP alert and alarm (Resting Heart mode only) and ALP alert and alarm events. The button will scroll through the options of Stop, Coast, Message, and None. 5-94 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Options Menu Screen 5. Press the button displaying the low flow value to edit the value. The corresponding Low Flow pop-up window will appear. 6. Press the Up/Down arrows until the desired low flow value is displayed. Press the edited value to accept the value. If the new value is not confirmed, the low flow value will revert back to the old value and the pop-up window will clear. 7. Edit the Bio-Pump response to either Message Only or Stop. Note: The default Bio-Pump response is Message Only. 8. Press to return to the Main Menu. Note: When the Performer CPB is powered off, any edits to low flow or the pressure limit value will be saved. Edits to pump responses entered in these screens will revert to the settings stored in the active User Profile established by the System Administrator in the Configuration Mode. Roller Pump Setup The pressure limits, pump responses, tube size setting, and units of measure (L/min, mL/min, or RPM) of each roller pump can be individually edited to meet the needs for a specific case. 2 6 3 4 7 5 7 Figure 5-37. Roller Pump Settings 1. Press from the Main Menu to confirm or edit the settings for pressure limits, pump responses, units of measure (L/min, mL/min, RPM), and tube size for the roller pumps. 2. The red identifier indicates which roller pump is associated with the parameters viewed. Note: The default roller pump reference “PM1” corresponds to the lower-left pump on the front of the console. Press to switch the red identifier. Going counterclockwise, the remaining pumps are referenced as PM2, PM3, and PM4. 3. Scroll through RPM, L/min, and mL/min. 4. Scroll through 6.4 mm (1/4 in), 9.5 mm (3/8 in), or 6.4 mm (1/4 in) and 6.4 mm (1/4 in) (PM1 and PM2 only). Note: Only roller pumps PM1 and PM2 include the option to edit the tubing ID in this screen. The tubing ID for roller pumps PM3 and PM4 are edited using the Cardioplegia Setup Screens. 5. Press the pressure limit value to be edited. A pop-up window will appear. Operator’s Manual A14113002 Rev. 2.0 5-95 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Options Menu Screen 6. Press the Up/Down arrows to edit the limit value. The system accepts positive or negative values. Press the edited value to accept the value. If the new value is not confirmed, the pressure limit will revert back to the old value and the pop-up window will clear. 7. Edit the pump response to PR1 ALERT and PR1 ALARM. The button will scroll through the options Stop, Pause, Message, and None. 8. Repeat steps 3 through 7 for pumps PM2, PM3, and PM4. 9. Press to accept the settings and return to the Main Menu. Note: When the Performer CPB is powered off, any edits to low flow or the pressure limit value will be saved. Edits to pump responses entered in these screens will revert to the settings stored in the active User Profile established by the System Administrator in the Configuration Mode. Safety System Pump response to events generated by various devices (air sensors, pressure sensors, flow sensors, roller pumps, Bio-Pump) can be edited prior to initiation of cardiopulmonary bypass or during the case. 1 2 Resting Heart mode 4 3 Bio-Pump CPB mode Figure 5-38. Safety System Configuration Edit Screens 1. Press to confirm or edit the Bio-Pump and roller pump responses to events. A prompt window will open asking “Yes/No” confirmation to the request to change the safety systems settings. Indicate “Yes” by pressing the green checkmark. Note: When the Performer CPB is powered off, any edits to low flow or the pressure limit values will be saved. Edits to pump responses entered in these screens will revert to the settings stored in the active User Profile established by the System Administrator in the Configuration Mode. 5-96 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Options Menu Screen 2. Scroll through the safety system events to be configured. When the right scroll arrow is pressed, the events appear in the sequence as shown in Table 5-8. 3. Once an event is selected, confirm the appropriate pump response for the Bio-Pump and the four roller pumps. Responses to events include Stop, Coast (Bio-Pump only), Pause (roller pumps only), Message, and None (see definitions, Table 5-9). To change/edit responses, press the Pump Response Select button for the Bio-Pump and individual roller pumps. 4. Press to accept the settings and return to the Menu Screen. Table 5-8. Safety System Events Event Description Used In Resting Heart Used In Bio-pump CPB AIR DETECTED BY ABD (ALARM) Occurs when the TransonicTM arterial flow transducer with air bubble sensor detects air. YES YES AIR IN CARDIOPLEGIA CIRCUIT (ALARM) Occurs when the cardioplegia ultrasonic air/fluid sensor detects air. YES YES AIR IN VARD (ALERT) Occurs when air is detected by the upper pair of ultrasonic sensors in the VARD. YES NO TOO MUCH AIR IN VARD (ALARM) Occurs when air is detected by the lower pair of ultrasonic sensors in the VARD. YES NO LOW BLOOD LEVEL ALERT Occurs when fluid in the reservoir drops below the position of the yellow level sensor. NO YES LOW BLOOD LEVEL ALARM Occurs when the fluid in the reservoir drops below the position of the red level sensor. NO YES BIO-PUMP STOP Occurs when the Bio-Pump enters the Stop Mode. YES YES BIO-PUMP COAST Occurs when the Bio-Pump enters the Coast Mode. YES YES BIO-PUMP BACKFLOW (ALERT) Occurs when negative flow is detected by the TransonicTM arterial flow transducer. YES YES BIO-PUMP LOW FLOW (ALERT) Occurs when the arterial flow detected by the TransonicTM arterial flow transducer drops below the low flow limit selected in the Bio-Pump Setup Screen and the pump RPM is greater than 2000. YES YES BIO-PUMP HIGH FLOW (ALERT) Occurs when the Bio-Pump is in the Venous Line Pressure Servo Mode and the pump speed exceeds 125% of the speed when servo was engaged. YES YES OVERPRESSURE ALERT: ALP Occur when the Arterial Line Pressure (ALP) limits selected in the pressure channel configuration screen for PR6 are exceeded. (See “Pressure Mode Selection” on page 5-84.) YES YES OVERPRESSURE ALARM: ALP Operator’s Manual A14113002 Rev. 2.0 5-97 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Options Menu Screen OVERPRESSURE ALERT: PR1 Occur when the line pressure limits selected in the pressure channel configuration screen are exceeded. (See “Roller Pump Pressure Channel Limit Settings” on page 5-86.) YES YES Occur when the Venous Line Pressure (VLP) limits selected in the pressure channel configuration screen for PR5 are exceeded. (See “Pressure Mode Selection” on page 5-84.) YES NO Occur when the line pressure limits selected in the pressure channel configuration screen are exceeded. (See “Roller Pump Pressure Channel Limit Settings” on page 5-86.) NO YES YES YES OVERPRESSURE ALARM: PR8 Occur when the line pressure limits selected in the pressure channel configuration screen are exceeded. (See “Roller Pump Pressure Channel Limit Settings” on page 5-86.) PUMP COVER OPEN: PM1 Occur when the interlock sensor on the pump cover is lifted off the pump housing. YES YES OVERPRESSURE ALERT: PR2 OVERPRESSURE ALARM: PR2 OVERPRESSURE ALERT:PR3 OVERPRESSURE ALARM: PR3 OVERPRESSURE ALERT: PR4 OVERPRESSURE ALARM: PR4 OVERPRESSURE ALERT: VLP OVERPRESSURE ALARM: VLP OVERPRESSURE ALERT: PR5 OVERPRESSURE ALARM: PR5 OVERPRESSURE ALERT: PR7 OVERPRESSURE ALARM: PR7 OVERPRESSURE ALERT: PR8 PUMP COVER OPEN: PM2 PUMP COVER OPEN: PM3 PUMP COVER OPEN: PM4 Table 5-9. Common Bio-Pump and Roller Pump Response Definitions Response Stop 5-98 A14113002 Rev. 2.0 Operator’s Manual Definition A Stop response causes the pump speed to go to zero and the motor to enter the Stop Mode. The pump must be restarted manually after the event is cleared or the safety system is disabled. If a Stop response is executed while the Bio-Pump is in the Servo Mode, the pump will switch to the Manual Mode after it is restarted. PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Options Menu Screen Coast (for Bio-Pump only) In Resting Heart mode, a Coast response causes the Bio-Pump speed to reduce to a flow of 0.5 L/min. As the pump speed adjusts to achieve 0.5 L/min, the transient RPM change may not be sufficient to prevent backflow or may be high enough to allow some forward flow. The pump flow will remain at 0.5 L/min until the event is cleared or the safety system is disabled. The pump speed will then automatically ramp up its speed to the previous level. Warning: If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY ABD” alarm, pump flow will remain at 0.5 L/min and will not automatically ramp up after the air is no longer detected by the ABD or after the ABD is turned off. Flow can only be resumed manually after careful assurance that air has been completely removed from the arterial circuit. In the Bio-Pump CPB mode, a Coast response causes the Bio-Pump speed to be reduced to an RPM of 2000. This RPM may not generate sufficient pressure to prevent backflow, or it may be enough to allow some forward flow. The pump will remain at 2000 RPM until the event is cleared or the safety system is disabled. The pump speed will then automatically ramp up its speed to the previous level. Warning: If the Bio-Pump enters the Coast mode in response to the “AIR DETECTED BY ABD” alarm, pump speed will remain at 2000 RPM and will not automatically ramp up after the air is no longer detected by the ABD or after the ABD is turned off. Flow can only be resumed manually after careful assurance that air has been completely removed from the arterial circuit. Pause (for roller pumps only) A Pause response causes the roller pump speed to be temporarily reduced to zero. The speed remains at zero until the event is cleared or the safety system is disabled. The pump will then automatically start and gradually ramp up its speed to the previous/original level. Message A Message response causes a message about the event to appear in the top line of the message bar. The message may occur concurrent with the other visual and audible cues representing an alert or alarm condition. None If None is selected, then no safety system connection is established between the device and the pump. The AutoClamp System incorporates a pneumatically powered tube clamp on the arterial line that serves to prevent retrograde flow from the aorta into the venous reservoir when the Bio-Pump events STOP, COAST, BACKFLOW, or LOW FLOW occur. Table 5-10. AutoClamp Response Definitions Response Definition CLOSE A CLOSE response causes the solenoid valve in the AutoClamp Interface Module to release gas pressure and allow the spring clamp in the Remote Tube Clamp to pinch the tubing. The clamp remains in the CLOSE position until (1) the AutoClamp is disabled or (2) the condition that initiated the clamp to CLOSE has been corrected. NO RESPONSE If NO RESPONSE is selected, then no safety system connection is established between the AutoClamp and the Bio-Pump event. Note: These configuration options are only selectable when running the Bio-Pump CPB mode. Operator’s Manual A14113002 Rev. 2.0 5-99 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Options Menu Screen Patient Information Note: Entering information into the Patient Information Screens will cause the alpha-numeric keyboard to appear over the Main Run Screen and the Cardioplegia Screen. This is the only situation when a secondary screen operation covers the Main Run Screen and the Cardioplegia Screen. Warning: Using the Pre-Cardiopulmonary Bypass Parameters Screen with the alpha-numeric keyboard during the conduct of cardiopulmonary bypass will cover essential perfusion and cardioplegia delivery information screens. Enter data prior to initiating bypass. Do not use during bypass. 3 2 4 Screen 3? 5 Figure 5-39. Entering Pre-Cardiopulmonary Bypass Patient Data 1. Press to open the Patient Information Screens. 2. In screen 1, press the appropriate lavender buttons to enter PATIENT ID, SURGEON, PERFUSIONIST #1, PERFUSIONIST #2, ANESTHESIOLOGIST, and NOTES. The alpha-numeric keyboard will appear for entry of information. Use the Up/Down scroll arrows to view lines. Note: The Parameter button must be pressed to accept entered information. 3. Press to change to screen 2 and enter prebypass patient and perfusion parameters. 4. Press to change to screen 3 and view calculated pre-cardiopulmonary bypass parameters. 5. Press to scroll/select the desired BSA formula: BSA (DUBOIS), BSA (BOYD), or BSA (INFANT). 6. Press to return to the Main Menu. Pressure, Temperature, Flow Parameters Simultaneous viewing of all eight pressure channels, all eight temperature channels, or the flows of the four roller pumps is accessed through the following Main Menu options. 5-100 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Options Menu Screen 1. Press to open the secondary screens to view the values being monitored by the eight pressure channels, the eight temperature channels, or the four roller pump flows. 2. Press or to scroll and view the channels displaying: ■ Eight temperature channels ■ Flow rates for the 4 roller pumps ■ Eight pressure (mm Hg) channels. In the PRESSURES (MMHG) screen, each button can be used to confirm or edit the ALERT pressure limit for that channel. 3. Press the desired pressure channel. A pop-up window will appear for that channel displaying the ALERT limit. 4. To edit, press the Up/Down arrows until the desired pressure value is displayed. The system will accept either positive or negative values. 5. Press the edited value to accept the value. If the new value is not confirmed, the pressure limit will revert back to the old value and the pop-up window will clear. 6. Press to return to the Main Menu. Trending 2 3 5 4 Figure 5-40. Trending Screen Operator’s Manual A14113002 Rev. 2.0 5-101 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Options Menu Screen 1. Press to open the Trending Screens. 2. Scroll through categories Others, Pressures, and Temperatures. 3. Scroll through the parameters for each category (see Table 5-11 for complete list of parameters). Note: Pressing at the bottom of the Main Run Screen begins trending.The trending clock will not start until the Pump Timer button is pressed regardless of how long the entire system has been running. 4. The X-axis scale represents elapsed time since the “On Pump” start time. ■ The first point of the trend is created after 1 minute, then each minute thereafter. ■ The beginning of the graph displays the range 00:00 to 01:30. ■ If trending extends beyond 01:30, the range shifts right by 30 minutes. The range always displays 90 minutes. 5. The Y-axis scale contains either a fixed range or begins with an initial range that is determined by the first value detected (see Table 5-11). This way, the initial value detected is initially centered on the Y-axis and the minimum and maximum values are constantly and automatically updated while trending graphs are created. 6. Press to return to the Main Menu. ■ Table 5-11. Trending Parameters and Y-Axis Ranges OTHERS PRESSURES Parameter Y Axis Range* Parameter Y Axis Range Oxygen Concentration (mL/min)* 0-300 0-400 0-500 100-300 100-400 100-500 PR1 to PR4 Initial pressure reading of + and 20 mm Hg Hematocrit (%)* 10-30 10-40 10-50 VLP Initial pressure reading of + and 20 mm Hg Oxygen Saturation (%)* 40-100 50-100 ALP Initial pressure reading of + and 20 mm Hg Bio-Pump Flow (L/min)* 0.00-4.00 0.00-5.00 0.00-6.00 0.00-7.00 0.00-8.00 VARD Initial pressure reading of +10 mm Hg to - 30 mm Hg Cardiac Index (L/min/M2 BSA)* 0.00-3.00 0.00-4.00 1.00-3.00 1.00-4.00 PR8 Initial pressure reading of + and 20 mm Hg TEMPERATURE Parameter Y Axis Range T1 - T8 Initial temperature reading of + and - 2°C * One of the following Y-axis ranges is initially chosen depending on the parameter value at the moment the pump timer is started. The system attempts to retain the possible range. If necessary, the range is expanded to visualize all the sampled values. 5-102 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Options Menu Screen Events Log The Events Log Screen time stamps events as they occur. 2 Figure 5-41. Events Log Screen 1. Press to open the Events Log Screens. 2. Press the Up/Down arrows to view past events. 3. Press to return to the Options Menu Screen. The events log icons are associated with events as indicated in Table 5-12. The most recent events entered in the log appear at the top of the list. Table 5-12. Events Log Icons Icon Associated Activities ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ Starting and stopping timers. Starting and stopping cardioplegia delivery. Enabling and disabling the VARD Auto Mode. Enabling and disabling the VARD servo (lower and upper sensors). Enabling and disabling the VLP servo. Enabling and disabling the ABD. Enabling and disabling the cardioplegia air sensor. Safety system modifications. System status messages that appear in the top line of the message bar. Bio-Pump status messages that appear in the top line of the message bar. Activation of all safety system alerts. Activation of all software and hardware operation systems alerts. Activation of all safety system alarms. Activation of all software and hardware operation systems alarms. All events captured in the Events Log Screens are downloaded onto the CompactFlash® memory card after the Home button is pressed and while the Home Screen is being viewed. Note: At the conclusion of a case, allow a minimum of 10 seconds (or until the hourglass disappears) for the data download to complete before powering off the console. Printer 1. Press the Printer button from the Main Menu. A query screen will appear asking, “Do you really want to print the report sheet?” Press the green checkmark to print. Press the red X to cancel the print request. Operator’s Manual A14113002 Rev. 2.0 5-103 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Servo (Resting Heart mode only) The Printed Report 1. 2. 3. 4. Hospital Information entered in the Configuration Mode. Patient Information entered in the Patient Information Screen. Treatment Data Events collected during cardiopulmonary bypass. Treatment Data Parameters collected every 5 minutes during cardiopulmonary bypass beginning when the pump timer is started and ending when the pump timer is stopped. Servo (Resting Heart mode only) Venous Line Pressure Servo The VLP servo automates the relationship between pump RPM and changes in venous line pressure (VLP). When the VLP servo is engaged and the venous line pressure becomes more negative, the system automatically reduces pump RPM to facilitate a consistent VLP value. Note: The VLP servo does not override the Bio-Pump safety system responses for Coast or Stop. 1. Ensure the venous line pressure is set with a fluid/air isolator and is properly primed. 2. Ensure the VLP pressure port is zeroed and the female connector of the pressure set luer is securely connected to the transducer port labeled VLP. 3. It is recommended that the VLP servo only be enabled when patient hemodynamics are stable. 5-104 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Servo (Resting Heart mode only) Bio-Pump Configuration Before initiating VLP servo during CPB, open the Bio-Pump Edit Screen and confirm the settings per Figure 5-42. 3 1 4 2 Figure 5-42. Bio-Pump Settings 1. 2. 3. 4. 5. Confirm that the VLP alert pressure is set to -100 mm Hg. Confirm that the Bio-Pump response to VLP alert is Message. Confirm that the VLP alarm pressure is set to -200 mm Hg. Confirm that the Bio-Pump response to VLP alarm is Coast. Press when the Bio-Pump settings are confirmed. Activating the VLP Servo 1 4 5 6 3 Figure 5-43. VLP Servo Operation 1. Ensure that the system status LED is green and the message bar is blank. 2. Ensure that the cardiopulmonary hemodynamics (blood flow, patient arterial pressure, system venous line pressure) are stable and that the heart is sufficiently decompressed. 3. Press the gray VLP Servo button on the Main Run Screen. When enabled, ■ The Servo will “capture” the current venous line pressure (VLP) and display that pressure in a window above the enabled Servo button. ■ The Servo button will turn blue The green/red Bio-Pump control offset indicator will appear below the VLP Servo icon. 4. The servo will “capture” the venous line pressure (VLP) being displayed on the Main Run Screen. ■ Operator’s Manual A14113002 Rev. 2.0 5-105 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Servo (Resting Heart mode only) 5. Pump RPM will adjust up or down to maintain the captured VLP. 6. If venous line pressure becomes more negative, the Bio-Pump flow is automatically reduced to return to the captured VLP. The Bio-Pump flow reduction is indicated by the green bar: green (real flow) is shorter than the red (pump speed RPM knob setting). 7. If the VLP becomes less negative, the Bio-Pump flow is automatically increased to return to VLP. Bio-Pump flow increasing is indicated by the green bar: green (real flow) is longer than the red (pump speed RPM knob setting). 8. Bio-Pump flow increase is limited to 125% of the initial value. If the Bio-Pump flow reaches the 125% maximum limit, ■ the system status LED changes to yellow ■ the top line of the message bar displays Bio-Pump high flow ■ audible alert tones will sound Alert and Alarm Conditions If an acute change in venous line pressure occurs and activates either the VLP alert or the VLP alarm and the Bio-Pump response is set to Message Only, Coast, or Stop, the VLP Servo Mode will either remain enabled or become disabled per Table 5-13. Table 5-13. VLP Alert and Alarm VLP ALERT Message Coast VLP ALARM Stop Message Coast Stop Status Light YELLOW RED Top Message Bar (Blue) VLP OVERPRESSURE (Red) VLP OVERPRESSURE Bottom Message Bar (N/A) Bio-Pump Coast Bio-Pump Stop (N/A) Acoustic Signal ALERT ALERT ALERT ALARM ALARM ALARM VLP Servo REMAINS BECOMES ENABLED DISABLED BECOMES DISABLED REMAINS ENABLED BECOMES DISABLED BECOMES DISABLED Note: The minimum flow the Bio-Pump can be reduced to is 0.5 L/min in the Coast Mode. The Bio-Pump Speed RPM Knob Turning the Bio-Pump speed RPM knob will cause the red bar to move, but will not result in a change of pump RPM or pump flow. To discontinue VLP servo and regain manual control of Bio-Pump flow: 1. Press the VLP servo icon and the button will turn to gray. 2. If necessary, rotate the Bio-Pump speed RPM knob counterclockwise to position the red bar shorter than the green bar. 3. When the green/red bar disappears, manual control of the Bio-Pump is regained. 5-106 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Medtronic Confidential CS017 Instructions for Use Servo (Resting Heart mode only) VARD Servo The VARD servo automates the relationship between pump RPM and the occurrence of air in the VARD. When the VARD servo is engaged and air enters the VARD, the system automatically reduces pump RPM to facilitate efficient removal of the air. The VARD servo overrides the pump responses set up for the “Air In VARD” and “Too Much Air In VARD” safety systems. The system will indicate with acoustic and visual indicators when air does enter the VARD. 1. When on CPB, make sure there is no air in the VARD. 2. Open the VARD/AAR Controller Secondary Screen and ensure that the AAR Controller is in the Auto Mode. 3. Ensure that the system status LED is green. 4. Press the gray VARD Servo button on the Main Run Screen. When enabled, the button will turn blue. 5. In the VARD/AAR Controller Secondary Screen, the VARD icon will change to a button with one pair of red arrows. These arrows indicate the servo will be activated when air is detected across the lower sensors. Operator’s Manual A14113002 Rev. 2.0 5-107 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Servo (Resting Heart mode only) 6. When air is detected by the lower sensors, ■ the system status LED changes to red ■ the display “TOO MUCH AIR IN VARD: CHECK VACUUM” appears in the top line of the message bar ■ the Bio-Pump flow reduces to a minimum of 0.5 L/min ■ the green/red Bio-Pump control offset indicator appears ■ the VARD Servo button in the Main Run Screen will display a red downward arrow until the Bio-Pump reaches a flow of 0.5 L/min ■ audible alert tones sound ■ the red “TOO MUCH AIR IN VARD” icon appears in the Secondary Screen ■ the mechanical pinch valve automatically opens the pinch valve icon changes to red and displays “OPEN” 7. When air is cleared above the lower sensors, ■ ■ the system status LED changes to yellow ■ the top line in the message bar changes from “TOO MUCH AIR IN VARD: CHECK VACUUM” to “AIR IN VARD” ■ audible alert tones remain active ■ the red “TOO MUCH AIR IN VARD” icon changes to the yellow “AIR IN VARD” icon ■ the mechanical pinch valve remains open ■ the pinch valve icon remains red and displays “OPEN” ■ the green/red Bio-Pump control offset indicator remains active the Bio-Pump flow remains at 0.5 L/min 8. When the air is cleared from the VARD, ■ ■ the system status LED changes to green ■ the display “AIR IN VARD” clears from the top line of the message bar ■ audible alert tones stop ■ the mechanical pinch valve closes ■ the pinch valve icon changes to green and displays “CLOSED” ■ the Bio-Pump flow gradually ramps up towards normal ■ the green bar of the Bio-Pump control offset indicator will extend over the red bar as the Bio-Pump flow returns to normal ■ the VARD Servo button in the Main Run Screen will display a red upward arrow until the Bio-Pump flow returns to normal when the Bio-Pump RPM returns to the setting of the pump speed RPM knob, the green/red Bio-Pump control offset indicator clears and the upward arrow above the VARD servo icon clears 9. Press the VARD Device button in the Secondary Screen. The icon will display a second pair of red arrows. These arrows indicate the servo will be activated when air is detected across the upper pair of sensors. ■ 5-108 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Preparing for Cardiopulmonary Bypass Checklist 10. The upper pair of sensors will engage the VARD servo only when they detect small amounts of air continuously for 3 seconds and, ■ the system status LED changes to yellow ■ the top line of the message bar displays “AIR IN VARD” ■ the Bio-Pump flow is reduced by 10% ■ the green/red Bio-Pump control offset indicator appears ■ the top of the VARD Servo button in the Main Run Screen will display a red downward arrow ■ audible alert tones will sound ■ the yellow “AIR IN VARD” icon appears in the secondary screen ■ the pinch valve icon turns red and displays “OPEN” Note: The minimum flow the Bio-Pump can be reduced to is 0.5 L/min. 11. When air is cleared above the upper sensors, ■ the system status LED returns to green ■ the Bio-Pump flow ramps back up to normal ■ the VARD Servo button in the Main Run Screen will display a red upward arrow and the Bio-Pump flow will increase by 20% every second until the original flow is achieved ■ the “AIR IN VARD” display clears from the top line of the message bar ■ the audible alert tones stop ■ the yellow VARD icon clears from the Secondary Screen ■ the pinch valve automatically closes ■ the pinch valve icon turns green and displays “CLOSED” when the actual pump RPM reaches the knob setting RPM, the green/red Bio-Pump control offset indicator clears 12. To disable VARD servo, ■ ■ ensure the green/red Bio-Pump control offset indicator is cleared from the Main Run Screen ■ press the VARD Servo icon; when it turns gray, servo is disabled Preparing for Cardiopulmonary Bypass Checklist Proper surgical procedures and techniques are the responsibility of the medical professional. These instructions are provided for informational purposes only. Each medical professional must evaluate the appropriateness of the procedure based on his/her own medical training, experience, the type of surgical procedure, and the patient condition. Prior to each use, it is the responsibility of the clinician to determine that the Performer CPB is in proper operating condition, as described in this manual. Do not use the system if proper operating conditions are not verified. Warning: READ CAREFULLY ALL WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE FOR ALL RELATED MEDTRONIC® EXTRACORPOREAL DEVICES PRIOR TO USE. FAILURE TO READ AND FOLLOW ALL INSTRUCTIONS, OR FAILURE TO OBSERVE ALL STATED WARINGS, COULD CAUSE SERIOUS INJURY OR DEATH TO THE PATIENT. Operator’s Manual A14113002 Rev. 2.0 5-109 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:04 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Preparing for Cardiopulmonary Bypass Checklist Figure 5-44. Resting Heart Configuration Figure 5-45. Bio-Pump CPB Configuration, Right Side, Back and Front Figure 5-46. Oxygen-Air Blender Configuration, Left Side, Front and Back 5-110 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Preparing for Cardiopulmonary Bypass Checklist Ensure all brackets, holders, and accessories (O2-Air Blender, anesthesia vaporizer) are properly mounted, positioned and secured to their respective poles. Ensure the Performer CPB is running on AC power and has passed the Power On Self-Test. (See “Power On Self-Test” on page 5-17.) Adjust the height of the console according to the procedure being conducted. Ensure the Performer CPB is properly configured per the Department of Perfusion Policy and Procedure Manual or conforms to the hospital's protocols for conducting extracorporeal support procedures. (See “System Configuration” on page 5-16.) Confirm a CompactFlash® memory card with sufficient available memory is inserted into the PCMCIA slot and the indicator LED is green. (See “CompactFlash® Memory Card with PCMCIA Adapter Installation” on page 5-15.) Confirm that the CID is functioning properly. Confirm that the roller pump insert is properly “sized” for the tubing being used in the roller pump. Turn on each roller pump and ensure they are functioning properly. Confirm that the rotation of each roller pump conforms to the intended direction of forward flow for the tubing in the pump. Confirm that the battery is fully-charged. (See “Checking the Battery” on page 5-44.) Confirm that the uninterruptible power supply is functioning properly by briefly disconnecting the AC power cord from the electrical source. (See “Checking the Battery” on page 5-44.) Confirm that the extracorporeal circuit is properly assembled, set up, and primed according to the product and manufacturer's recommendations or Instructions for Use. Warning: Ensure that all components in the circuit have been debubbled and primed properly prior to beginning bypass to minimize the risk of air reaching the patient. If air bubbles or leaks are observed during priming and/or operation, these conditions may result in air embolism to the patient and/or fluid loss. Connect the ultrasonic flow transducer to the arterial line. Confirm proper orientation. (See “Setup and Operation of the Arterial Line ABD System” on page 5-63.) Zero the pressure transducers. (See “Zeroing the Pressure Transducers” on page 5-87.) Connect the pressure monitoring lines. (See “Pressure Monitoring Sets with Air/Fluid Isolators Setup” on page 5-88.) Confirm that the alert and alarm safety limits are properly configured. (See “Editing Pressure Limits for the Current Case Only” on page 5-85.) Confirm that the minimum flow limit is properly set. Connect the Venous Saturation/Hematocrit transducer to the in-line cuvette. Confirm that the alert values for OXYGEN SATURATION: LOW VALUE and HEMATOCRIT: LOW VALUE are properly set. (See “Venous Saturation and Hematocrit Monitoring” on page 5-90.) Connect the temperature probes between the HTS Module and either the extracorporeal circuit or the patient. Operator’s Manual A14113002 Rev. 2.0 5-111 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Initiating Extracorporeal Support Checklist When using the Medtronic Resting Heart Module and running the Performer CPB in Resting Heart mode, confirm that the VARD cable is connected to the console. When using the Medtronic Resting Heart Module and running the Performer CPB in Resting Heart mode, confirm that the wall vacuum pressure displayed in the AAR Controller screen is set between -200 mm Hg and -210 mm Hg. Enable each safety device using the buttons on the CID and confirm their proper functionality. a. Arterial Air Bubble Detection (ABD) (See “Setup and Operation of the Arterial Line ABD System” on page 5-63.) b. AAR Controller in Auto Mode when running the Performer CPB in Resting Heart mode. c. Level Detection when running the Performer CPB in Bio-Pump CPB mode (see “Set-up and Operation of the Level Sensing System” on page 5-67). d. Arterial Backflow Prevention when running the Performer CPB in Bio-Pump CPB mode (see “AutoClamp System (Bio-Pump CPB mode only)” on page 5-73). Turn the Bio-Pump speed RPM knob clockwise and confirm proper functionality of the Bio-Pump. Open the Patient Information Secondary Screen and enter the patient ID, height, weight, the circuit prime volume, anesthesia IV fluid volume infused, and pre-bypass laboratory hemoglobin and hematocrit values. Confirm that the system status LED is green and there are no alerts in the message bar. If the LED is yellow, reference the alert(s) in the top line of the message bar. Do not initiate extracorporeal support until all alert conditions have been corrected and the system status LED is green. Confirm that a Bio-Pump handcrank is immediately available for emergency use. Initiating Extracorporeal Support Checklist Warning: Only persons thoroughly trained in cardiopulmonary bypass procedures should use the Performer CPB. The operation of the system requires constant supervision by qualified personnel for patient safety. Warning: Ensure that all components in the circuit have been debubbled and primed properly prior to beginning bypass to minimize the risk of air reaching the patient. If air bubbles or leaks are observed during priming and/or operation, these conditions may result in air embolism to the patient and/or fluid loss. Warning: Ensure all patient intravenous fluid lines are connected securely to prevent air entrainment. Warning: All gaseous bubbles have the potential for gaseous emboli and must be handled carefully. Safety/Warning devices are recommended to aid in the detection and elimination of gaseous bubbles in the extracorporeal circuit. Position the Performer CPB next to the patient and set the wheel brakes. Check for adequate levels of anticoagulation prior to initiation of bypass. 5-112 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_5.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Instructions for Use Initiating Extracorporeal Support Checklist Warning: A strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all procedures. The benefits of extracorporeal support must be weighed against the risk of systemic anticoagulation and must be assessed by the prescribing physician. Adequate heparinization must be maintained before and during bypass. Cannulate the patient for arterial and venous vascular access. Clamp the arterial and venous circuits. Connect the arterial line and thoroughly de-air the cannula-circuit connection. Connect the venous line and thoroughly de-air the cannula-circuit connection. If indicated, perform retrograde autologous prime per patient tolerance. Set the FiO2 on the oxygen-air blender per the manufacturer's recommendations for the membrane oxygenator being used. Set the gas flow on the oxygen-air blender per the manufacturer's recommendations for the membrane oxygenator being used. Turn the Bio-Pump speed RPM knob clockwise and increase pump RPM sufficient to generate a pressure that will prevent backflow. Release the arterial and venous clamps on the extracorporeal circuit and gradually increase blood flow. Warning: To prevent backflow of the patient's blood when the pump outlet tubing is open: ■ Establish and maintain a minimum pump speed that overcomes line and patient resistance when running the Resting Heart mode. Failure to do this could allow backflow and exsanguinate the patient. ■ Connect the AutoClamp System and enable Backflow Prevention when running the Bio-Pump CPB mode.Failure to do this could allow arterial backflow and introduce air into the arterial circuit. Start the pump timer. (See “Pump and Clamp Timer Operation” on page 5-46.) Resting Heart mode: Reference the Main Run Screen of the CID to assess the adequacy of venous return. a. Check the Venous Line Pressure (VLP). (See “Main Run Screen” on page 5-41.) b. Closely monitor the VLP. Adjust blood flow or administer volume as necessary to ensure that the negative pressure does not become more negative than -60 mm Hg. Reference the Main Run Screen of the CID to assess the adequacy of arterial flow. a. Pump Flow b. Pump RPM c. Cardiac Index d. Arterial Line Pressure (ALP) e. Venous Saturation (OXYGEN SAT) Warning: Frequent patient and system monitoring is recommended. Do not leave the system unattended while in use. Adjust the pump flow as necessary to achieve an OXYGEN SAT that conforms to practice guidelines. Operator’s Manual A14113002 Rev. 2.0 5-113 PerformerV1.5_EN_5.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 5 Initiating Extracorporeal Support Checklist Adjust the pump flow as necessary to achieve a patient Mean Arterial Pressure (MAP) monitored on the physiologic monitor that conforms to practice guidelines. Respond immediately to correct any system alarm that occurs as indicated by distinct audible cues concomitant with the following visual cues on the CID: a. the system status LED will change to red b. the message bar will change to red c. a description of the alarm will appear in the top line of the message bar Respond appropriately to correct any system alert that occurs as indicated by distinct audible cues concomitant with the following visual cues on the CID: a. the system status LED will change to yellow b. a description of the alert will appear in the top line of the message bar Bio-Pump CPB mode: Closely monitor the blood level in the venous reservoir to assess the adequacy of venous return. a. Reduce Bio-Pump flow if the blood volume drops to the manufacturer's recommended safe minimum reservoir operating level. b. Connect and enable the reservoir level safety system to prevent emptying the venous reservoir. (See page 5-67) Reference the Main Run Screen of the CID to assess the adequacy of arterial flow. (See “Main Run Screen” on page 5-41) a. Pump Flow b. Pump RPM c. Cardiac Index d. Arterial Line Pressure (ALP) e. Venous Saturation (OXYGEN SAT) Warning: Frequent patient and system monitoring is recommended. Do not leave the system unattended while in use. While closely monitoring the blood level in the venous reservoir, adjust the pump flow as necessary to achieve an OXYGEN SAT that conforms to practice guidelines. While closely monitoring the blood level in the venous reservoir, adjust the pump flow as necessary to achieve a patient Mean Arterial Pressure (MAP) monitored on the physiologic monitor that conforms to practice guidelines. Respond immediately to correct any system alarm that occurs as indicated by distinct audible cues concomitant with the following visual cues on the CID: a. the system status LED will change to red. b. the message bar will change to red. c. a description of the alarm will appear in the top line of the message bar. Respond appropriately to correct any system alert that occurs as indicated by distinct audible cues concomitant with the following visual cues on the CID: a. the system status LED will change to yellow. b. a description of the alert will appear in the top line of the message bar. 5-114 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_6.fm 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Medtronic Confidential CS017 Cleaning and Maintenance 6 6 Cleaning 6-2 Maintenance 6-2 Operator’s Manual A14113002 Rev. 2.0 6-1 PerformerV1.5_EN_6.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 6 Cleaning Cleaning ■ Unplug the equipment before cleaning to avoid electrical shock. ■ Do not use chemical solvents such as methyl ethyl ketone, alcohol, ether, acetone, FORANE®, or acid based solutions in or on any part of the equipment, as such solvents may be destructive to the device and its internal components. Do not use abrasive cleaners or cleaning solvents other than those recommended in this manual. ■ The surface of the whole system (including pump heads, tube occlusion roller, and tube guide rolls) shall be thoroughly cleaned after each use, in order to avoid the accumulation of contaminated or corrosive fluids. ■ All the external surfaces can be easily cleaned and disinfected for blood, saline, or other spilled contaminants using normal medial equipment cleaners and disinfectants such as bleach (5.25%) and hydrogen peroxide (3%). Note: The Level Sensors’ “sensing suface” may be cleaned with isopropyl alcohol. ■ Because fluids should not be allowed to enter any openings, do not apply cleaning solution with a spray. ■ Clean the equipment with a sponge or soft cloth moistened with water or a mild detergent. ■ After the equipment is cleaned, wipe the unit with a cloth moistened with water to remove any cleaning solution residue and then wipe the unit with a dry cloth. ■ If it is suspected that fluid penetrated into the equipment, the unit should be unplugged and immediately examined by a trained, service technician. ■ Clean the VARD FIL and the cardioplegia air bubble sensor channels to ensure maximum sensor sensitivity. ■ Do not use alcohol on the VARD sensor cable ends where the connectors are exposed. ■ It is recommended that preventative maintenance be completed every 6 months to ensure accurate performance and reliability and to guarantee safe use of the equipment. ■ The user is not in charge of particular maintenance operations. All maintenance is performed by authorized, service personnel. ■ Setup operations, updates, modifications, and repairs must be performed by trained personnel authorized by the manufacturer with authorized parts from the manufacturer. ■ Only trained personnel authorized by the manufacturer are allowed to access the internal parts of the equipment. Maintenance User Maintenance Checks Test the Uninterruptible Power Supply (UPS) every three months using the following procedure, or sooner if you suspect the battery readings are incorrect. When the entire system is operating with tubing in the pumps, temporarily disconnect the wall power supply. 1. Check that the audible battery alert tones sound. 6-2 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_6.fm 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Medtronic Confidential CS017 Cleaning and Maintenance Maintenance 2. Check the power status icon on the CID changes to indicate Battery Power. 3. Confirm the message BATTERY MODE is displayed in the top line of the Message Bar. 4. Check the power status icon for the estimated battery time remaining as the battery discharges. The battery should begin with at least 30 minutes of power. Run the system for 30 minutes on battery power and monitor the power status icon in the CID for the estimated battery time remaining. Recharge the batteries by operating the system using wall power supply with the system power on. Operator’s Manual A14113002 Rev. 2.0 6-3 PerformerV1.5_EN_6.fm 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 6 Maintenance 6-4 A14113002 Rev. 2.0 Operator’s Manual Medtronic Confidential CS0023 PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting 7 7 General Information 7-2 Alarms Alerts 7-2 7-2 Simultaneous Activation of Alarms/Alerts 7-2 Priority of Alarms 7-3 Alarm Resetting 7-3 Self-Resetting Alarms 7-4 Emergency Procedures 7-4 Alarms 7-20 Alerts 7-27 Operator’s Manual A14113002 Rev. 2.0 7-1 PerformerV1.5_EN_7.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 General Information General Information The equipment is designed to signal situations requiring the user's intervention. Two types of signals can be distinguished: ■ Alarms ■ Alerts Alarms Alarms are activated when the equipment malfunctions or when an EVENT condition occurs that might jeopardize the patient's safety. An alarm condition is signaled to the user by: ■ illumination of the red system status LED on the top of the display ■ the sounding of an audible signal with a 1-second frequency ■ the message bar changing to a red background ■ a description of the alarm is present in the top line of the message bar (black text on red background) Alarms Conditions and Messages A complete list of conditions that may activate an alarm message can be found in the table beginning on page 7-20. Alerts Alerts are activated every time the user's attention or intervention is required, but the patient's safety and the equipment functionality are not jeopardized. Alerts are signaled to the user by: ■ illumination of the yellow system status LED on the top of the display ■ the sounding of an audible signal with a 1-minute frequency ■ a description of the alert is present in the top line of the message bar (yellow text on blue background) Alert Conditions and Messages A complete list of conditions that may activate an alarm message can be found in the table beginning on page 7-27. Simultaneous Activation of Alarms/Alerts The top line of the Message Bar in the CID displays alarm and alert conditions according to their priority. If more than one alarm/alert is present, the equipment will function in the following ways: 7-2 A14113002 Rev. 2.0 ■ If only alerts are active, they are cyclically browsed at 1.5-second intervals. Alerts do not have an order of priority. ■ If only alarms are active, the alarm with the highest priority is displayed in the top line of the Message Bar until cleared. If a second alarm condition still exists after the first has been cleared, then that alarm condition will be displayed in the top line of the Message Bar. Operator’s Manual PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting General Information ■ If both alarms and alerts are simultaneously active, the alarms are first displayed in order of their priority. Once all the alarm conditions have been removed, the top line of the Message Bar will cyclically display the alert conditions at 1.5-second intervals. ■ At any time during the case, the user can view all alarms and alert messages and the time the condition occurred by pressing the Events Log Button. Priority of Alarms Alarm conditions will be displayed in the top line of the Message Bar according to the following priority: Resting Heart mode only: 1. Air detected by ABD 2. Too much air in VARD: Check Vacuum 3. VLP overpressure 4. Bio-Pump excessive stop 5. VARD: blood being removed 6. ALP overpressure 7. Pinch-valve not closed 8. Pinch-valve not opened 9. Air in cardioplegia circuit 10. PR4 (cardioplegia circuit) overpressure 11. PR1 overpressure 12. PR2 overpressure Bio-Pump CPB mode only: 1. AutoClamp Not Open 2. Air Detected by ABD 3. Bio-Pump Excessive Stop 4. ALP Overpressure 5. Air in cardioplegia circuit 6. Level Sensor Error 7. Low Blood Level 8. AutoClamp Not Closed 9. AutoClamp Closed and Flow Still Present 10. PR4 (cardioplegia) overpressure 11. PR1 overpressure 12. PR2 overpressure 13. PR3 overpressure Alarm Resetting ■ When an alarm occurs, the “alarm mute” icon ( message bar. ) is shown at the right of the ■ To mute the alarm, the user should press the “alarm mute” icon. ■ Once the cause of the alarm is cleared, the user should reset the alarm by pressing the “confirmation” icon ( ) shown at the right of the message bar. Operator’s Manual A14113002 Rev. 2.0 7-3 PerformerV1.5_EN_7.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 Emergency Procedures Self-Resetting Alarms The following alarms will automatically reset once the alarm condition is removed: Resting Heart mode only: ■ Pressure alarms ■ Pinch valve alarms ■ Too much air in VARD: Check Vacuum Bio-Pump CPB mode only: ■ Pressure alarms ■ Low Blood level alarms Emergency Procedures This section is intended to assist the user to operate the Performer CPB in a proficient manner should an actual emergency occur. It is recommended to practice operating the system using a bench-model or “wet-run” circuit. Air Detected by ABD This section assumes: ■ the Bio-Pump has been configured to either Stop, Coast, or Message in response to the alarm “AIR DETECTED BY ABD” ■ the arterial line Air Bubble Detector/blood flow sensor is properly positioned on the circuit ■ the ABD has been enabled in the Main Run Screen The immediate indications of an emergency condition are: ■ the system status LED changes to red ■ the sounding of distinct audible alarm tones ■ the message bar turns red ■ “AIR DETECTED BY ABD” appears in the top line of the message bar ■ the ABD icon in the Main Run Screen indicates “AIR DETECTED BY ABD” User Interventions when runing Resting Heart mode and Bio-Pump CPB mode without the AutoClamp: ■ 7-4 A14113002 Rev. 2.0 Operator’s Manual If the Bio-Pump has been configured to Message Only, immediately turn the Bio-Pump speed RPM knob fully counterclockwise to stop the pump and immediately clamp the arterial and venous lines. PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting Emergency Procedures ■ If the Bio-Pump has been configured to Stop or Coast, immediately clamp the arterial line to prevent backflow. ■ Immediately clamp the venous line to prevent exsanguination of the patient (Bio-Pump CPB mode). ■ Confirm the event by reading the message “AIR DETECTED BY ABD” in the top line of the message bar. ■ Immediately identify the cause for the emergency condition. ■ Ensure the cardioplegia pump(s) PM3 and/or PM4 and the LV vent pump PM2 are stopped. It is recommended to configure the roller pump response for PM2, PM3, and PM4 to Stop for the event Bio-Pump Coast or Bio-Pump Stop. Warning: Do NOT press as this will immediately disable the ABD and prevent enabling the ABD until after flow is resumed. ■ Mute the alarm as required. ■ Clear all air from the circuit. ■ Reset the air bubble detection safety system so that it is enabled. ■ To resume cardiopulmonary bypass, the Bio-Pump speed RPM knob must be turned fully counterclockwise to restart the Bio-Pump. ■ Increase the Bio-Pump RPM to a speed that will produce the minimal amount of forward flow. Remove the arterial clamp and confirm the Bio-Pump is generating forward flow. Remove the venous line clamp and resume cardiopulmonary bypass. User Interventions when running Bio-Pump CPB mode with AutoClamp: ■ If the Bio-Pump has been configured to Message Only, immediately turn the Bio-Pump speed RPM knob fully counterclockwise to stop the pump and immediately clamp the arterial and venous lines. ■ If the AutoClamp has been configured to CLOSE in response to Bio-Pump Stop or Bio-Pump Coast, immediately clamp the venous line to prevent exsanguination of the patient. ■ Confirm the event by reading the message "AIR DETECTED BY ABD" in the top line of the message bar. ■ Immediately identify the cause for the emergency condition. ■ Ensure the cardioplegia pump(s) PM3 and/or PM4 and the LV vent pump PM2 are stopped. It is recommended to configure the roller pump response for PM2, PM3, and PM4 to Stop for the event Bio-Pump Coast or Bio-Pump Stop. Warning: Do NOT press as this will immediately disable the ABD and prevent enabling the ABD until after flow is resumed. ■ Mute the alarm as required. ■ Clear all air from the circuit. Warning: Do not open the RTC after automatic closure prior to removing all air from the circuit and confirming complete absence of air in the arterial circuit. ■ Reset the air bubble detection safety system so that it is enabled. ■ To resume cardiopulmonary bypass, the Bio-Pump speed RPM knob must be turned fully counterclockwise to resume forward flow. ■ Increase the Bio-Pump RPM to > 2200. Press the AutoClamp button in the Main Run Screen to open the RTC. ■ Confirm the Bio-Pump is generating forward flow. Remove the venous line clamp and resume cardiopulmonary bypass. ■ Press the AutoClamp button to enable. Operator’s Manual A14113002 Rev. 2.0 7-5 PerformerV1.5_EN_7.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 Emergency Procedures Too Much Air in VARD: Check Vacuum (Resting Heart mode only) This alarm condition occurs when the VARD/AAR Controller is in the AUTO Mode and the fluid level in the VARD drops below the lower pair of sensors. The immediate indications are: ■ The system status LED changes to red ■ Distinct audible alarm tones sound ■ The message bar changes to red ■ “TOO MUCH AIR IN VARD: CHECK VACUUM” appears in the top line of the message bar User Intervention: 1. Bio-Pump flow reduction may be required until venous air is reduced or eliminated. The Bio-Pump will automatically reduce flow if it is configured to Coast or Stop in response to this alarm condition. 2. Check the position of the venous cannula for the possibility of openings being outside the heart and exposed to the atmosphere. 3. Check the security of the venous cannula purse string for the possibility of entraining air around the cannulation site. 4. Check for loose connections and luer fittings on the venous line proximal to the VARD. 5. Ensure the AAR Controller vacuum is set between -200 mm Hg and -210 mm Hg. 6. Once the fluid level in the VARD is above the lower pair of sensors, the alarm indications will automatically clear. Low Blood Level (Bio-Pump CPB mode only) This alarm condition occurs when the fluid level drops below the position of the red (alarm) sensor on the reservoir. The immediate indications are: ■ The system status LED changes to red ■ Distinct audible alarm tones sound ■ The message bar changes to red ■ "LOW BLOOD LEVEL" appears in the top line of the message bar User Intervention: ■ Bio-Pump flow reduction may be required until the volume in the reservoir returns above the position of the sensor. The Bio-Pump will automatically reduce flow if it is configured to Stop or Coast in response to this alarm condition. ■ If the Bio-Pump has been configured to Stop or Coast, immediately clamp the arterial line to prevent backflow unless the AutoClamp feature is enabled and configured to CLOSE in response to Bio-Pump Stop or Bio-Pump Coast. ■ Confirm the event by reading the alarm message "LOW BLOOD LEVEL" in the top line of the red message bar. ■ Check the position of the venous cannula for the possibility that gravity venous drainage is restricted. ■ Check the security of the venous cannula purse string for the possibility of entraining air around the cannulation site. ■ If necessary, add volume to the reservoir. Once the fluid level in the reservoir returns above the red sensor, the alarm indications will automatically clear. 7-6 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting Emergency Procedures ■ To resume cardiopulmonary bypass from the Bio-Pump Stop mode, the Bio-Pump speed RPM knob must be turned fully counterclockwise to resume forward flow. ■ Increase the Bio-Pump RPM to a speed to > 2200. ■ Remove the clamp on the arterial line. If using the AutoClamp feature, press the AutoClamp button in the Main Run Screen to open the RTC. Confirm the Bio-Pump is generating forward flow. ■ If the Bio-Pump is configured to Coast, the pump speed will automatically ramp up. If using the AutoClamp feature, the RTC will automatically open when the Bio-Pump motor reaches 2200 RPM. ■ Monitor the volume in the reservoir while pump flow is being returned to normal. Level Sensor Failure (Bio-Pump CPB mode only) This condition occurs when the sensors are incorrectly placed on the reservoir (the red alarm sensor detects air while the yellow alert sensor detects fluid) or if a sensor is damaged. The immediate indications are: ■ The System Status LED changes to red ■ A distinct audible alarm tone sounds ■ The message bar changes to red ■ “LEVEL SENSORS ERROR” appears in the top line of the message bar User Intervention: ■ Mute the alarm ■ Disable the level sensing system ■ Reposition the sensors. Confirm the yellow alert sensor is positioned on the reservoir above the alarm sensor. Ensure that the sensor positions on the reservoir are more than 1 cm away from internal structures of the reservoir. ■ Confirm the "arrows" on the reservoir icon in the Main Run Screen change to green when detecting fluid. ■ Reset the alarm. The System Status LED will change to yellow. ■ Press the level sensing button to enable the Level Sensing system. The System Status LED will change to green. ■ If the sensors do not detect fluid, contact a Medtronic Service representative. Overpressure Alarm When a pressure exceeds the user-defined alarm limit: ■ The System Status LED changes to red ■ A distinct audible alarm tone sounds ■ The message bar changes to red ■ The top line of the message bar displays the pressure channel that was exceeded (OVERPRESSURE ALARM: ALP, OVERPRESSURE ALARM: PR4, etc) ■ The appropriate pressure pop-up window will appear ■ Pump speed(s) may change depending on the factory default pump responses, configuration settings, or changes made during editing pump responses. If the pump response is set to Stop, Coast (Bio-Pump), or Pause (Roller Pump): ■ The pressure will drop below the alarm limit and the alarm indicators will clear automatically Operator’s Manual A14113002 Rev. 2.0 7-7 PerformerV1.5_EN_7.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 Emergency Procedures ■ The pressure pop-up window will remain visible User Intervention for OVERPRESSURE ALARM for pressure channels PR1, PR2, PR3, and PR4: 1. Correct the high pressure condition. 2. If necessary, reset the value for the pressure limit using the pressure pop-up window and confirm the new pressure limit value. Caution: When the alarm pressure limit pop-up window is visible, the buttons in the secondary screen become inactive. The top button in the pop-up window displaying the pressure limit value must be pressed to clear the pop-up window before the buttons in the secondary screen become active. 3. Start the pump(s) if configured to Stop for an alarm condition. User Interventions for OVERPRESSURE ALARM: ALP when running RESTING HEART mode or BIO-PUMP CPB mode without the AutoClamp: ■ If the Bio-Pump has been configured to Message Only, immediately turn the Bio-Pump speed RPM knob counterclockwise to reduce line pressure below the alarm limit setting. ■ If the Bio-Pump has been configured to Stop or Coast, immediately clamp the arterial line to prevent backflow. ■ Immediately clamp the venous line to prevent exsanguination of the patient (BIO-PUMP CPB mode). ■ Confirm the event by reading the message "OVERPRESSURE ALARM: ALP" in the top line of the message bar. ■ Ensure the cardioplegia pump(s) PM3 and/or PM4 and the LV vent pump PM2 are stopped. It is recommended to configure the roller pump response for PM2, PM3, and PM4 to Stop for the event Bio-Pump Stop or Bio-Pump Coast. ■ Immediately identify and correct the cause for the Overpressure condition. ■ If necessary, reset the value for the pressure limit using the pressure pop-up window and confirm the new pressure limit value. Caution: When the alarm pressure limit pop-up window is visible, the buttons in the secondary screen become inactive. The top button in the pop-up window displaying the pressure limit value must be pressed to clear the pop-up window before the buttons in the secondary screen become active. ■ To resume cardiopulmonary bypass from the Bio-Pump Stop mode, the Bio-Pump speed RPM knob must be turned fully counterclockwise to resume forward flow. ■ Increase the Bio-Pump RPM to > 2200. ■ If the Bio-Pump is configured to Coast, the pump speed will automatically ramp up when the pressure drops below the Alarm limit value. ■ Remove the clamp on the arterial line. Confirm the Bio-Pump is generating forward flow. Remove the venous line clamp and resume cardiopulmonary bypass. User Interventions for OVERPRESSURE ALARM: ALP when running Bio-Pump CPB mode with AutoClamp: 7-8 A14113002 Rev. 2.0 ■ If the Bio-Pump has been configured to Message Only, immediately turn the Bio-Pump speed RPM knob counterclockwise to reduce line pressure below the alarm limit setting. ■ If the AutoClamp has been configured to CLOSE in response to Bio-Pump Stop or Bio-Pump Coast, immediately clamp the venous line to prevent exsanguination of the patient. ■ Confirm the event by reading the message "OVERPRESSURE ALARM: ALP" in the top line of the message bar. Operator’s Manual PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting Emergency Procedures ■ Ensure the cardioplegia pump(s) PM3 and/or PM4 and the LV vent pump PM2 are stopped. It is recommended to configure the roller pump response for PM2, PM3, and PM4 to Stop for the event Bio-Pump Coast or Bio-Pump Stop. ■ Immediately identify and correct the cause for the Overpressure condition. ■ If necessary, reset the value for the pressure limit using the pressure pop-up window and confirm the new pressure limit value. Caution: When the alarm pressure limit pop-up window is visible, the buttons in the secondary screen become inactive. The top button in the pop-up window displaying the pressure limit value must be pressed to clear the pop-up window before the buttons in the secondary screen become active. ■ To resume cardiopulmonary bypass from the Bio-Pump Stop mode, the Bio-Pump speed RPM knob must be turned fully counterclockwise to resume forward flow. ■ Increase the Bio-Pump RPM to > 2200. ■ Press the AutoClamp button in the Main Run Screen to open the RTC. ■ If the Bio-Pump is configured to Coast, the pump speed will automatically ramp up when the pressure drops below the Alarm limit value and the RTC will automatically open when the RPM reaches 2200. ■ Confirm the Bio-Pump is generating forward flow. Remove the venous line clamp and resume cardiopulmonary bypass. ■ Press the AutoClamp button to enable. Bio-Pump Excessive Stop This alarm condition occurs when the Pump Timer is running and the Bio-Pump has been in the Stop Mode for more than 60 seconds. The immediate indications are: ■ The System Status LED changes to Red ■ Distinct audible alarm tones sound ■ The message bar changes to red ■ “BIO-PUMP EXCESSIVE STOP” appears in the top line of the message bar User Intervention: 1. Confirm whether the pump timer is suppose to be running or stopped. 2. If indicated, press the Pump Timer Stop button. The Bio-Pump Excessive Stop alarm will clear. 3. Correct the condition that caused the Bio-Pump to stop and then restart the Bio-Pump. 4. Reset the alarm. VARD: Blood Being Removed (Resting Heart mode only) This alarm condition occurs when the VARD/AAR Controller is in the AUTO Mode and the FIL Sensor detects fluid for 3 or more consecutive seconds. The immediate indications are: ■ The System Status LED changes to red ■ Distinct audible alarm tones sound ■ The message bar changes to red ■ “VARD: BLOOD BEING REMOVED” appears in the top line of the message bar User Intervention: 1. Confirm the presence of venous air causing the condition of either the AIR IN VARD alert or the TOO MUCH AIR IN VARD: CHECK VACUUM alarm. Operator’s Manual A14113002 Rev. 2.0 7-9 PerformerV1.5_EN_7.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 Emergency Procedures 2. If there is no AIR IN VARD alert or TOO MUCH AIR IN VARD: CHECK VACUUM alarm, immediately clamp the VARD purge line. 3. Correct the condition causing the Pinch Valve to remain open. 4. Reset the alarm if necessary. Pinch Valve Not Closed (Resting Heart mode only) This alarm condition occurs when the VARD/AAR Controller is in the AUTO Mode and the sensors that detect the position of the Pinch Valve indicate the Pinch Valve is open when the conditions maintain it should be closed. This condition will be caused by the user manually pressing the mechanical Button on top of the Pinch Valve. This condition may result in excess blood being removed through the VARD Purge Line. The immediate indications are: ■ The System Status LED changes to red ■ Distinct audible alarm tones sound ■ The message bar changes to red ■ “VARD: PINCH VALVE NOT CLOSED” appears in the top line of the message bar User Interventions: 1. Do not press the Mechanical Button when the VARD/AAR Controller is in the Auto Mode. 2. Immediately clamp the VARD Purge Line. 3. Closely monitor the venous line for introduction of air into the VARD. 4. Closely monitor the VARD for the accumulation of air. 5. Unclamp the VARD purge line when the system alerts “AIR IN VARD” 6. Unclamp the VARD purge line when the system alarms “TOO MUCH AIR IN VARD: CHECK VACUUM.” Pinch Valve Not Open (Resting Heart mode only) This alarm condition occurs when the VARD/AAR Controller is in the AUTO Mode and the sensors that detect the position of the Pinch Valve indicate the Pinch Valve is closed when the conditions maintain it should be open (ie, during AIR IN VARD or TOO MUCH AIR IN VARD: CHECK VACUUM conditions). This may result in venous air not being removed from the VARD. The immediate indications are ■ The System Status LED changes to red ■ Distinct audible alarm tones sound ■ The message bar changes to red ■ “VARD: PINCH VALVE NOT OPEN” appears in the top line of the message bar User Interventions: 1. Press the Pinch Valve icon in the VARD/AAR Controller screen. This will cause the pinch valve to open for 0.5 seconds and then close. 2. If the Pinch Valve fails to open when pressing the Pinch Valve icon, press on the Mechanical Button to open the Pinch Valve when the system alerts AIR IN VARD 3. Press on the Mechanical Button to open the Pinch Valve when the system alarms TOO MUCH AIR IN VARD: CHECK VACCUM 4. Closely monitor the VARD for the accumulation of air. 5. Reset the alarm as necessary. 7-10 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting Emergency Procedures CPG Air Detected This section assumes: ■ the cardioplegia roller pump (PM4) has been configured to either Stop, Pause, or Message Only in response to the event “AIR IN CARDIOPLEGIA CIRCUIT” ■ the cardioplegia circuit pump outlet line is properly positioned in the air sensor and the ABD has been enabled in the Cardioplegia Run Screen Cardioplegia Run Screen: CPG Air Sensor Enabled The immediate indications of an emergency condition are: ■ the system status LED changes to red ■ the sounding of distinct audible alarm tones ■ the message bar turns red ■ “AIR IN CARDIOPLEGIA CIRCUIT” appears in the top line of the message bar ■ the cardioplegia ABD icon changes to red User Interventions: ■ If the CPG roller pump (PM4) has been configured to Message Only, immediately turn the roller pump speed control knob fully counterclockwise to stop the pump and immediately clamp the delivery line. ■ If the CPG roller pump (PM4) has been configured to Stop or Coast, immediately clamp the delivery line. ■ Confirm the event by reading the message “AIR IN CARDIOPLEGIA CIRCUIT” in the top line of the message bar. ■ Immediately identify the cause for the emergency condition. ■ Mute the alarm as required by pressing the Alarm Mute button once. Warning: Pressing the cardioplegia ABD icon to silence the alarm will also disable the cardioplegia ABD, indicated by the ABD icon changing to gray. The alert “CARDIOPLEGIA AIR SENSOR DISABLED” will appear in the top line of the message bar and the system status LED will change to yellow. ■ Clear all air from the circuit. ■ Ensure the cardioplegia ABD is reset and that it is enabled and the cardioplegia ABD icon is green. Operator’s Manual A14113002 Rev. 2.0 7-11 PerformerV1.5_EN_7.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 Emergency Procedures ■ Remove the clamp and resume cardioplegia delivery by turning the roller pump speed control knob slowly clockwise. AutoClamp Not Closed (Bio-Pump CPB mode only) Gas pressure keeps the RTC in the OPEN position. When gas pressure is released, the RTC closes. This alarm condition occurs when sensors that detect the position of the Remote Tube Clamp indicate it is open when the conditions maintain it should be closed. This condition may result in arterial backflow and entrainment of air into the arterial line. The immediate indications are: ■ The System Status LED changes to red ■ Distinct audible alarm tones sound ■ The message bar changes to red ■ “AUTOCLAMP NOT CLOSED” appears in the top line of the message bar. User Interventions: ■ If the Bio-Pump speed has been reduced below 2000 RPM or has automatically entered the Stop or Coast mode, immediately clamp the arterial line to prevent backflow and the venous line to prevent exsanguination. Note: This alarm indication displayed in the red Message Bar will prevent viewing the alert BIOPUMP BACKFLOW. Reference the Events Log screen to confirm the sequence of potential events (BIOPUMP STOP or BIOPUMP COAST, BIOPUMP BACKFLOW, AUTOCLAMP NOT CLOSED) associated with this alarm condition. 7-12 A14113002 Rev. 2.0 ■ Ensure the AutoClamp button on the Main Run Screen is green to indicate the system is ON. ■ Ensure the communication cable between the RTC and the ACI module is properly connected. ■ Ensure the communication cable between the ACI Module and the Performer CPB Console is properly connected. ■ Ensure the 3/8" ID tube is properly seated in the RTC. ■ Immediately identify and correct the event that would cause the Bio-Pump flow to be reduced or to enter the Stop or Coast mode ■ To resume cardiopulmonary bypass from the Bio-Pump Stop mode, the Bio-Pump speed RPM knob must be turned fully counterclockwise. To resume forward flow, increase the Bio-Pump RPM to >2200. ■ If the Bio-Pump is configured to Coast, the pump speed will automatically ramp up when causative event has been corrected. ■ Remove the clamp on the arterial line. Confirm the Bio-Pump is generating forward flow. Remove the venous line clamp and resume cardiopulmonary bypass. ■ Contact the Medtronic Service representative. Operator’s Manual PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting Emergency Procedures AutoClamp Not Open (Bio-Pump CPB mode only) Gas pressure keeps the RTC in the OPEN position. When gas pressure is released, the RTC closes. This alarm condition occurs when the sensors that detect the position of the Remote Tube Clamp indicate it is closed when the conditions maintain it should be open. This condition will prevent delivery of blood flow. The immediate indications are: ■ The System Status LED changes to red ■ Distinct audible alarm tones sound ■ The message bar changes to red ■ "AUTOCLAMP NOT OPEN" appears in the top line of the message bar. User Interventions: ■ Confirm gas pressure lines are properly connected to the ACI Module and the RTC. ■ Confirm the Events Log Screen is not displaying the alert AUTOCLAMP PRESSURE LOW. ■ Ensure the AutoClamp button on the Main Run Screen is green to indicate the system is ON. ■ Press the green AutoClamp button on the Main Run Screen to disable the AutoClamp and open the RTC. The button will change to gray with a red X. ■ If the RTC fails to open, remove the tubing from the RTC and resume cardiopulmonary bypass. ■ Closely monitor the system for changes in Bio-Pump RPM that may precipitate a backflow condition. When necessary, use tubing forceps to clamp the arterial line for backflow prevention. ■ Contact the Medtronic Service representative. AutoClamp Closed and Flow Still Present (Bio-Pump CPB mode only) Gas pressure keeps the RTC in the OPEN position. When gas pressure is released, the RTC closes. This alarm condition occurs when the RTC is closed but the ultrasonic flow sensor on the arterial line still detects blood flow when it should be 0.00 L/min. The immediate indications are: ■ The System Status LED changes to red ■ Distinct audible alarm tones sound ■ The message bar changes to red ■ “AUTOCLAMP CLOSED AND FLOW STILL PRESENT” appears in the top line of the message bar. User Interventions: ■ If the Bio-Pump speed has been reduced below 2000 RPM or has automatically entered the Stop or Coast mode, immediately clamp the arterial line to prevent backflow and the venous line to prevent exsanguination. Note: This alarm indication displayed in the red Message Bar will prevent viewing the alert BIOPUMP BACKFLOW. Reference the Events Log screen to confirm the sequence of potential events (BIOPUMP STOP or BIOPUMP COAST, BIOPUMP BACKFLOW, AUTOCLAMP CLOSED AND FLOW STILL PRESENT) associated with this alarm condition. ■ Confirm the ultrasonic flow sensor is distal to the arterial filter and is not detecting flow through a purge line. Operator’s Manual A14113002 Rev. 2.0 7-13 PerformerV1.5_EN_7.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 Emergency Procedures ■ Ensure the 3/8" ID tube is properly seated in the RTC and the RTC door is fully closed. ■ To reposition the tube, press the red AutoClamp button on the Main Run Screen to disable the AutoClamp and open the RTC. The button will change to gray with a red X. ■ Unclamp the arterial and venous lines and resume cardiopulmonary bypass. ■ Press the gray AutoClamp button in the Main Run Screen to turn the AutoClamp System to ON. The button will turn green. ■ If the alarm condition recurs, contact the Medtronic Service representative. Unexpected and Immediate Initiation of Cardiopulmonary Bypass With a Primed Resting Heart™ System (Resting Heart mode only) Note: The system does not require pre-bypass setup or calibration procedures using the CID in order to emergently initiate cardiopulmonary bypass. The system can provide Bio-Pump and roller pump functionality 20 seconds after turning the power on. ■ Press the Main Power switch. ■ Ensure flow and Sat/Hct sensors are properly connected. ■ Connect the arterial air/fluid isolator to the pressure port labeled ALP. ■ Connect the venous air/fluid isolator to the pressure port labeled VLP. ■ Insert the VARD purge line into the pinch valve and connect the vacuum pressure line to PR7. ■ Turn on wall vacuum and set the regulator to -225 mm Hg ■ Connect arterial and venous lines to the patient cannulae. ■ Turn the Bio-Pump speed RPM knob to 800 RPM. ■ Remove the venous line clamp. ■ Remove the arterial line clamp and slowly increase the Bio-Pump speed control to initiate cardiopulmonary bypass. ■ Blood flow is displayed in the LEDs on the Bio-Pump control panel. ■ Venous Line Pressure (VLP) and Bio-Pump RPM are displayed in the LCDs on the Bio-Pump control panel. ■ Verify stable conduct of perfusion, then open the CID and enter “Resting Heart.” Loss of AC Power Supply Note the battery power status indicator and monitor during use. When the time remaining reaches 5 minutes: 7-14 A14113002 Rev. 2.0 ■ The system status LED changes to red ■ The message bar changes to red Operator’s Manual PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting Emergency Procedures ■ The top line of the message reads “LOW BATTERY” ■ The audible alarm tone sounds Loss or Failure of Battery Power: Total System Power Failure In the event the system fails to automatically convert to battery power, or the system has been operating on battery backup to the extent that battery power has been completely drained: ■ Use manual operation of the Bio-Pump with the external handcrank to maintain patient circulation ■ Use manual operation of the roller pumps with the integrated handcranks. ■ If using the AutoClamp System, clamp the arterial line and remove the arterial line from the Remote Tube Clamp. Warning: If a partially charged battery is used, there may be less than 30 minutes of battery power available. Warning: When the Uninterruptable Power Supply (UPS) converts the system to battery power, ALL pumps, pump functions, safety systems, alerts, alarms, monitors, controls, the Pinch Valve and the Central Information Display (CID) are active and function the same as when the system is on AC power. CID Failure In the event the CID malfunctions, causing the screen to “lock up” or go blank, the LCD on the Bio-Pump control panel serves as the emergency backup monitoring screen. The following parameters can be monitored: ■ Bio-Pump RPM ■ Venous Line Pressure ■ Arterial Line Pressure ■ Cardioplegia Line Pressure (PR4) ■ Venous Saturation ■ Hematocrit During CID malfunction, ALL safety connections and servos that were enabled using the CID before it failed would still be enabled and functional. This would include: ■ Arterial Line Air Bubble Detection ■ Cardioplegia Air Bubble Detection ■ Air-In-VARD Alert ■ Too Much Air In VARD Alarm ■ Pressure Alert and Alarm Safety Limits ■ Bio-Pump Low Flow ■ Bio-Pump Backflow ■ Minimum Hct ■ VLP Servo ■ VARD Servo Without the utility of the screen to manage an alarm condition in the event one is activated, it is necessary to disable all alarms. Enabling the Emergency Mode will temporarily disable all system alarms and servos. Operator’s Manual A14113002 Rev. 2.0 7-15 PerformerV1.5_EN_7.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 Emergency Procedures Warning: If the CID ceases to function, the Bio-Pump and the roller pumps will continue to operate through the local controls on the front panel of the console. Warning: If the CID ceases to function when there are safety systems enabled, the user will not be able to intervene (eg, mute an audible alarm, reset a safety device) in the event an alert or alarm is activated. Warning: If the CID ceases to function, DO NOT turn the power off in an attempt to reset or reboot the system. 1. To enable the Emergency Mode, press both scroll arrows simultaneously. The Bio-Pump control local LCD will change to: 1 2. Press the checkmark to confirm “Enable Emergency Mode.” When pressed, the following will also occur: ■ system alarms will become disabled ■ the system status LED will alternately flash between yellow and red 2 Warning: When the Emergency Mode is enabled, all safety systems are disabled. Warning: Closely monitor the perfusion circuit for changes in resistance to flow, indications of backflow, and introduction of air into either the venous circuit or the arterial circuit. 3. Press the top arrow to scroll and select the desired parameter to monitor in the upper half of the LCD. 7-16 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting Emergency Procedures 3 4. Press the bottom arrow to scroll and select the desired parameter to monitor in the lower half of the LCD. 4 5. To disable the Emergency Mode, press both scroll arrows simultaneously. 5 The LCD will change to: 6. Press the checkmark to confirm “Disable Emergency Mode.” 6 Bio-Pump Failure If the Bio-Pump does not spin, Operator’s Manual A14113002 Rev. 2.0 7-17 PerformerV1.5_EN_7.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 Emergency Procedures ■ Reset the motor controller by turning the pump speed RPM knob to zero for a minimum of 1 second. If the Bio-Pump either fails to start or stops spinning, ■ Clamp the arterial and venous lines to prevent backflow. ■ Remove the Bio-Pump pumphead from the remote drive motor. ■ Attach the handcrank adapter plate to the face of the remote drive motor. ■ Attach the Bio-Pump pumphead to the magnetic coupling on the handcrank. ■ Turn the handcrank in the direction of the yellow arrows on the case of the handcrank to spin the Bio-Pump pumphead. Note: If the handle is turned in the opposite direction of the arrows, the centrifugal pump still pumps fluid through the outlet, but the efficiency is reduced and the LED display does not illuminate. ■ Remove the clamps from the venous and arterial lines to resume blood flow. Roller Pump Failure Warning: Closely monitor the operation of the roller pumps for unexpected interruption of normal function. If a roller pump unexpectedly stops: ■ Determine if a safety system event occurred that is linked to the roller pump that is configured to Stop. Note: Check the Events Log Secondary Screen for discrete or multiple events that could result in a roller pump Stop response. ■ Check the pump display to see if the flow/RPM value is flashing. If it is flashing, press the Start/Stop button to restart the pump. ■ Check the top line of the message bar for a roller pump failure message. PM1 PUMP NOT RUNNING PM2 PUMP NOT RUNNING PM3 PUMP NOT RUNNING PM4 PUMP NOT RUNNING ■ This alarm will be accompanied with the system status LED changing to red, the message bar changing to red, and the sounding of audible alarm tones. ■ Press ■ If the problem persists, prepare a backup roller pump. , then press to reset the alarm. Resume roller pump operation. If a backup roller pump is available, and there is a sufficient length of tubing in the circuit, clamp the tubing, remove the tubing segment in the pump raceway, and install to a different roller pump that will accommodate the size of tubing. Warning: Always ensure proper direction of rotation before starting a backup roller pump and also ensure that the direction of forward flow for the tubing is consistent with the rotational direction of the roller pump. Always ensure that the direction of flow is NOT in a retrograde direction that would result in pumping air into the patient. If a backup roller pump is not available: 7-18 A14113002 Rev. 2.0 ■ lift the roller pump safety cover ■ unlatch the integrated handcrank ■ grasp the black knob and manually rotate the pump clockwise Operator’s Manual PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting Emergency Procedures Note: The rollers in the roller inserts are installed with one-way bearings to prevent inadvertent reverse handcranking. When tubing is installed in the pump raceway, the rotation of the pump will only occur in a clockwise direction. Warning: When handcrank operation of a roller pump is necessary due to a failure of the motor or motor controller, the roller pump digital display may remain illuminated. Any RPM/flow values that are being displayed will not correlate to the manual RPMs or flow generated using the handcrank. If a roller pump unexpectedly continues running after rotating the pump speed RPM knob fully counterclockwise or pressing the Start/Stop button: ■ Immediately check the top line of the message bar for a roller pump failure message. PM1 PUMP FAILED TO STOP PM2 PUMP FAILED TO STOP PM3 PUMP FAILED TO STOP PM4 PUMP FAILED TO STOP ■ This alarm will be accompanied with the system status LED changing to red, the message bar changing to red, and the sounding of audible alarm tones. ■ Press ■ If the roller pump continues running, carefully open the safety cover to activate the cover interlock. ■ If the roller pump continues running, clamp the tubing at the pump inlet. Contact a Medtronic service representative. , then press to reset the alarm. Bio-Pump Backflow Detected The immediate indications of an emergency condition are: ■ the system status LED changes to yellow ■ the alert “BIO-PUMP BACKFLOW” appears in the top line of the message bar ■ the sounding of audible alert tones Warning: The Bio-Pump backflow alert indicates backflow. When using gravity drainage, air may enter the arterial cannula. Before resuming antegrade flow, clamp the arterial line and check for air. Thoroughly remove all visible air before resuming bypass. User Interventions: ■ Clamp the arterial line. ■ Check the status of the Bio-Pump to ensure it has not unexpectedly stopped. Increase Bio-Pump speed as required to overcome patient arterial resistance. ■ Check to ensure the Bio-Pump has not decoupled from the remote drive motor. ■ Check the arrow on the ultrasonic flow sensor to ensure it is consistent with the forward direction of arterial flow. If necessary, replace the flow sensor. ■ Increase pump speed sufficient to overcome circuit resistance and then slowly unclamp the arterial line. Confirm antegrade flow. AAR Controller Failure (Resting Heart mode only) A failure mode with the AAR Controller will generate an alarm condition and: ■ the system status LED will change to red ■ the message bar will change to red ■ audible alarm tones will sound Operator’s Manual A14113002 Rev. 2.0 7-19 PerformerV1.5_EN_7.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 Alarms ■ the top line of the message bar will display the failure mode of the AAR Controller User Interventions: VARD: PINCH VALVE NOT CLOSED ■ Immediately clamp the VARD purge line to prevent excess blood being removed from the circuit. ■ Press ■ If the pinch valve remains open, closely monitor the top of the VARD for any accumulation of air. Release the clamp on the VARD purge line as required to evacuate air from the VARD without causing excess blood loss. , then press to reset the alarm. VARD: PINCH VALVE NOT OPEN ■ Press ■ . This will cause the pinch valve to open for 0.5 second and then close. If the pinch valve fails to open, press the Mechanical button on top of the pinch valve to evacuate air from the VARD. ■ Press , then press to reset the alarm. Alarms This section includes a list of the conditions that could occur with the system and generate an ALARM during a procedure. The following describes the details for each Alarm. 7-20 A14113002 Rev. 2.0 Message: The display of the Alarm condition that appears in the top line of the Message Bar of the CID. Cause: The description or explanation of the main cause for the Alarm. Resolution: Describes the recommended interventions by the user to remove the alarm condition. Message Cause Resolution AP01: CONTROL SYSTEM NOT RUNNING The control system generates a 'life' signal with a specific time shape that informs the protective system about its correct functioning and time-base. The alarm is activated in case of a 'control life' failure detected by the protective processor (after 3 seconds of missing or incorrect detection of the 'control life' signal). Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. AP02: USER INTERFACE SYSTEM NOT RUNNING Failure of the User Interface processor detected by the protective processor (after 15 seconds of missing or incorrect User Interface communication). Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. AB21: CPB VOLTAGE OUT OF RANGE CPB voltage is out of [4.75 … 5.30] Volt. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. Operator’s Manual PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting Alarms Message Cause Resolution AB22: CPB CONTROL COMMUNICATION FAILURE The alarm is activated after 5 seconds of absent or incorrect data reception from the control processor via the BCL link. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. AB23: CPB FLOW METER COMMUNICATION FAILURE The flow meter module provides real blood flow data via a dedicated serial link. The alarm is activated when a failure in the data acquisition from the flow meter is found (after 6 consecutive communication errors). Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. AB24: CPB VLP ACQUISITION FAILURE VLP reading error from dedicated acquisition driver. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. AB25: CPB ALP ACQUISITION FAILURE ALP reading error from dedicated acquisition driver. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. AB26: CPB RPM DEVIATION ERROR Error between the measured RPM and the setting value is higher than the maximum between 20% and 500 RPM. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A041: BCL COMMUNICATION FAILURE The alarm is activated after 5 seconds of absent or incorrect data reception from the CPB via the BCL link. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A042: PROTECTIVE SYSTEM NOT RUNNING The protective system generates a 'life' signal with a specific time shape that informs the control system about its correct functioning and time-base. The alarm is activated in case of a 'protective life' failure detected by the control processor (after 3 seconds of missing or incorrect detection of the 'protective life' signal). Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A043: USER INTERFACE SYSTEM NOT RUNNING Failure of the User Interface processor detected by the control processor (after 15 seconds of missing or incorrect User Interface communication). Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A044: HTS MODULE COMMUNICATION FAILURE The HTS module provides data from the insulated sensors (temperatures, oxygen saturation and hematocrit) to the control system via the dedicated serial link. The alarm is activated in case of a failure in the data acquisition from the HTS (after 5 consecutive communication errors). Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A045: POWER SUPPLY FAILURE Power supply failure: Main present and 24 Volt absent. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. Operator’s Manual A14113002 Rev. 2.0 7-21 PerformerV1.5_EN_7.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 Alarms Message Cause Resolution A046: UPS FUSES FAILURE UPS fuse failure in main power mode. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A047: INCORRECT UPS MODE UPS mode failure: battery mode in presence of main power and opposite situation. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A048: CONTROL VOLTAGE OUT OF RANGE Control voltage is out of [4.75 … 5.30] Volt. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A049: PROTECTIVE VOLTAGE OUT OF RANGE Protective voltage out of [4.75 … 5.30] Volt. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A050: DIFFERENT CONTROL/PROTECTIVE MODE Control and protection systems have non-congruent functioning modes. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A051: DIFFERENT CONTROL/PROT. THERAPY The alarm is activated in case of different control and protective therapies. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A052: DIFFERENT CONTROL/PROT. STATE Control and protection system detect two different functioning statuses. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A053: DIFFERENT VLP AND PR5 PRESSURES The absolute difference between VLP (pressure managed by CPB processor) and PR5 (pressure managed by control processor) is higher than 35 mm Hg for 10 seconds. Possible causes: ■ calibration problem ■ possible transducer failure Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A054: DIFFERENT ALP AND PR6 PRESSURES The absolute difference between ALP (pressure managed by CPB processor) and PR6 (pressure managed by control processor) is higher than 35 mm Hg for 10 seconds. Possible causes: ■ calibration problem ■ possible transducer failure Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. LOW BATTERY A056: UPS FAILURE 7-22 A14113002 Rev. 2.0 Operator’s Manual ■ Battery mode charge has fallen under 55%. Failure of the UPS (Uninterruptable Power Supply) Board. If possible, arrange the patient's disconnection. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting Alarms Message Cause Resolution A121: PM1 PUMP DRIVER FAILURE Failure of the PM1 roller pump electronic driver detected by the 'PM1-TFO' signal. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A122: EXCESSIVE CURRENT ON PM1 PUMP The alarm is activated in case of excessive current of the motor provided by ‘PM1-SEN’ signal, for preventing overheating or burning of the coil. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A124: PM1 PUMP FAILED TO STOP The encoder detects the PM1 pump running when it should be stopped. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A125: PM1 PUMP NOT RUNNING The encoder does not detect PM1 pump rotation when it should be running. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A127: PM1 ROTOR BLOCKED The rotation sensor does not detect PM1 rotor movement when it should be running. Possible causes: ■ the rotor is not inserted in its site ■ the rotation sensors are demagnetized ■ ■ ■ Correctly insert the rotor in its site. Replace the rotor. If the problem persists, turn off the pump and contact a service technician. A128: PM2 PUMP DRIVER FAILURE Failure of the PM2 roller pump electronic driver detected by the 'PM2-TFO' signal. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A129: EXCESSIVE CURRENT ON PM2 PUMP The alarm is activated in case of excessive current of the motor provided by ‘PM2-SEN’ signal, for preventing overheating or burning of the coil. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A131: PM2 PUMP FAILED TO STOP The encoder detects the PM2 pump running when it should be stopped. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A132: PM2 PUMP NOT RUNNING The encoder does not detect PM2 pump rotation when it should be running. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A134: PM2 ROTOR BLOCKED The rotation sensor does not detect PM2 rotor movement when it should be running. Possible causes: ■ the rotor is not inserted in its site ■ the rotation sensors are demagnetized A135: PM3 PUMP DRIVER FAILURE Failure of the PM3 roller pump electronic driver detected by the 'PM3-TFO' signal. ■ ■ ■ Correctly insert the rotor in its site. Replace the rotor. If the problem persists, turn off the pump and contact a service technician. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. Operator’s Manual A14113002 Rev. 2.0 7-23 PerformerV1.5_EN_7.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 Alarms Message Cause Resolution A136: EXCESSIVE CURRENT ON PM3 PUMP The alarm is activated in case of excessive current of the motor provided by ‘PM3-SEN’ signal, for preventing overheating or burning of the coil. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A138: PM3 PUMP FAILED TO STOP The encoder detects the PM3 pump running when it is should be stopped. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A139: PM3 PUMP NOT RUNNING The encoder does not detect PM3 pump rotation when it should be running. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A141: PM3 ROTOR BLOCKED The rotation sensor does not detect PM3 rotor movement when it should be running. Possible causes: ■ the rotor is not inserted in its site ■ the rotation sensors are demagnetized Rev. 2.0 ■ Failure of the PM4 roller pump electronic driver detected by the 'PM4-TFO' signal. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A143: EXCESSIVE CURRENT ON PM4 PUMP The alarm is activated in case of excessive current of the motor provided by ‘PM4-SEN’ signal, for preventing overheating or burning of the coil. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A145: PM4 PUMP FAILED TO STOP The encoder detects the PM4 pump running when it should be stopped. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A146: PM4 PUMP NOT RUNNING The encoder does not detect PM4 pump rotation when it should be running. Reset the alarm. If the problem persists, activate the emergency mode to proceed with the procedure and contact a service technician. A148: PM4 ROTOR BLOCKED The rotation sensor does not detect PM4 rotor movement when it should be running. Possible causes: ■ the rotor is not inserted in its site ■ the rotation sensors are demagnetized The alarm is activated in therapy when CPG air sensor self-test fails. ABD CABLE NOT CONNECTED ■ AIR DETECTED BY ABD ■ ■ ■ A14113002 ■ Correctly insert the rotor in its site. Replace the rotor. If the problem persists, turn off the pump and contact a service technician. A142: PM4 PUMP DRIVER FAILURE A162: CPG AIR SENSOR SELF-TEST FAILED 7-24 ■ Operator’s Manual ■ ■ ■ Correctly insert the rotor in its site. Replace the rotor. If the problem persists, turn off the pump and contact a service technician. Reset the alarm. If the problem persists, contact a service technician. Bio-Pump running. ABD cable disconnected. Connect ABD cable. ABD air sensor is enabled. ABD air sensor detects air. See detailed procedure in this chapter. PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting Alarms Message AIR IN CARDIOPLEGIA CIRCUIT Cause ■ ■ CPG air sensor is enabled. CPG air sensor detects air. Resolution See detailed procedure in this chapter. OVERPRESSURE: ALP ALP pressure is greater than the corresponding alarm limit. Correct overpressure condition and restart pumps (Bio-Pump and/or roller pumps) if stopped. BIO-PUMP EXCESSIVE STOP The Bio-Pump has remained still for more than 60 seconds (the alarm is active only if the pump timer is running). Restart the Bio-Pump. LOW BATTERY Remaining charge time is 05:00. OVERPRESSURE: PR1 PR1 pressure is greater than the corresponding alarm limit. Correct overpressure condition and restart pumps (Bio-Pump and/or roller pumps) if stopped. OVERPRESSURE: PR2 PR2 pressure is greater than the corresponding alarm limit. Correct overpressure condition and restart pumps (Bio-Pump and/or roller pumps) if stopped. OVERPRESSURE: PR3 PR3 pressure is greater than the corresponding alarm limit. Correct overpressure condition and restart pumps (Bio-Pump and/or roller pumps) if stopped. OVERPRESSURE: PR4 PR4 pressure is greater than the corresponding alarm limit. Correct overpressure condition and restart pumps (Bio-Pump and/or roller pumps) if stopped. OVERPRESSURE: PR7 PR7 pressure is greater the corresponding alarm limit. Correct overpressure condition and restart pumps (Bio-Pump and/or roller pumps) if stopped. OVERPRESSURE: PR8 PR8 pressure is greater than the corresponding alarm limit. Correct overpressure condition and restart pumps (Bio-Pump and/or roller pumps) if stopped. TOO MUCH AIR IN VARD: CHECK VACUUM ■ ■ ■ VARD: BLOOD BEING REMOVED ■ VARD: PINCH VALVE NOT CLOSED ■ VARD: PINCH VALVE NOT OPEN ■ VARD: TUBE NOT INSERTED IN PINCH VALVE ■ ■ ■ ■ ■ VARD Auto Mode is enabled. VARD servo is enabled. Air in VARD (lower sensors) Check venous cannula position. Check security of venous cannula purse string. Secure loose connection or luer fitting on venous line proximal to the VARD. VARD Auto Mode is enabled. Blood in FIL. The alarm is activated if, after 3 seconds from blood detection in FIL, the clamp remains open. Determine there is no alert “AIR IN VARD” or alarm “TOO MUCH AIR IN VARD: CHECK VACUUM” Clamp the VARD purge line. Correct pinch valve if open. VARD Auto Mode is enabled. The pinch valve position sensors detect an 'open' status when the pinch valve should be 'closed.' Do not press on the Mechanical button when in the Auto Mode. Clamp the VARD purge line. Unclamp the VARD purge line when the system alerts “AIR IN VARD.” VARD Auto Mode is enabled. The pinch valve position sensors detect a 'closed' status when the pinch valve should be 'open.' Press on the Mechanical button to open the pinch valve when the system alerts “AIR IN VARD.” VARD Auto Mode Line not inserted in the pinch valve. Insert the tubing in the pinch valve. Operator’s Manual A14113002 Rev. 2.0 7-25 PerformerV1.5_EN_7.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 Alarms 7-26 A14113002 Rev. 2.0 Message Cause Resolution OVERPRESSURE: PR5 PR5 (VLP in Resting Heart mode) pressure is greater than the corresponding alarm limit. Correct overpressure condition and restart pumps (Bio-Pump and/or roller pumps) if stopped. LEVEL SENSORS ERROR This alarm condition occurs when: ■ Two-sensor configuration is selected ■ level sensing is enabled ■ high level sensor sees fluid ■ low level sensor sees air Possible causes: ■ fluid between high and low sensor with low and high sensors in the reverse position (low sensor above high sensor) ■ fluid above the high level sensor but the low sensor sees air--low sensor could be damaged Check the correct positioning of the two sensors; if the position is correct, the low sensor could be damaged. LOW BLOOD LEVEL This alarm condition occurs when the fluid level drops below the position of the red (alarm) sensor on the reservoir. See page 7-6. AUTOCLAMP NOT CLOSED This alarm condition occurs when sensors that detect the position of the Remote Tube Clamp indicate it is open when the conditions maintain it should be closed. See page 7-12. AUTOCLAMP NOT OPEN This alarm condition occurs when the sensors that detect the position of the Remote Tube Clamp indicate it is closed when the conditions maintain it should be open. See page 7-13. AUTOCLAMP CLOSED AND FLOW STILL PRESENT RTC is closed but the ultrasonic flow sensor on the arterial line still detects blood flow when it should be 0.00 L/min. See page 7-13. Operator’s Manual PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting Alerts Alerts This section includes a list of the conditions that could occur with the system and generate an ALERT during a procedure. The following describes the details for each Alert. Message: The display of the Alert condition that appears in the top line of the Message Bar of the CID. Description: The description or explanation of the main cause for the Alert. Message Description ABD CABLE NOT CONNECTED The flow meter/air bubble detector cable has not been connected to the system. ABD OFF Air detected by ABD (with ABD not enabled and Bio-Pump running). AIR DETECTED BY ABD Air detected by the ABD (with ABD enabled and Bio-Pump running). AIR IN CARDIOPLEGIA CIRCUIT The cardioplegia air sensor is disabled and detects air. AIR IN VARD It is activated in one of the following conditions: ■ Standby Mode: air detected in VARD by lower or upper sensors. ■ Auto Mode: air detected in VARD by upper sensors. OVERPRESSURE: ALP ALP pressure is greater than the corresponding alert limit. BATTERY MODE The machine is operating in battery mode. BIO-PUMP: BACKFLOW Bio-Pump negative flow is detected by the flow meter. BIO-PUMP: HIGH FLOW VLP servo is activated and the Bio-Pump flow is greater than 125% of the initial value. BIO-PUMP: LOW FLOW Bio-Pump flow is lower than the corresponding “low flow” alert limit and the RPM is greater than 2000. CARDIOPLEGIA AIR SENSOR DISABLED The cardioplegia air sensor has been disabled by the user. DOSE DELIVERED Cardioplegia dose has been delivered. DRUG FLOW NOT REACHABLE It is activated in case of 2 pumps cardioplegia (with 3.2 mm (1/8 in) tubing in drug pump) when the actual cardioplegia flow and ratio setting determine a drug flow (PM3) greater than 160 mL/min. EMERGENCY MODE: ALL ALARMS DISABLED Emergency mode activated by the user; all the alarms and alerts are disabled. HEMATOCRIT: LOW VALUE Hematocrit value is lower than 20% and pump time is running. HIGH ARTERIAL (T1) TEMPERATURE Arterial temperature (probe connected to T1 inlet) is greater than 43.0°C HIGH VENOUS (T2) TEMPERATURE Venous temperature (probe connected to T2 inlet) is greater than 43.0°C Operator’s Manual A14113002 Rev. 2.0 7-27 PerformerV1.5_EN_7.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 Alerts 7-28 A14113002 Rev. 2.0 Message Description HIGH CARDIOPLEGIA (T3) TEMPERATURE Cardioplegia temperature (probe connected to T3 inlet) is greater than 43.0°C HIGH T4 TEMPERATURE Temperature probe connected to T4 inlet is greater than 43.0°C HIGH T5 TEMPERATURE Temperature probe connected to T5 inlet is greater than 43.0°C HIGH T6 TEMPERATURE Temperature probe connected to T6 inlet is greater than 43.0°C HIGH T7 TEMPERATURE Temperature probe connected to T7 inlet is greater than 43.0°C HIGH T8 TEMPERATURE Temperature probe connected to T8 inlet is greater than 43.0°C LOADING/UNLOADING PM1 PUMP SEGMENT Automatic tube loading/unloading feature activated for the PM1 pump. LOADING/UNLOADING PM2 PUMP SEGMENT Automatic tube loading/unloading feature activated for the PM2 pump. LOADING/UNLOADING PM3 PUMP SEGMENT Automatic tube loading/unloading feature activated for the PM3 pump. LOADING/UNLOADING PM4 PUMP SEGMENT Automatic tube loading/unloading feature activated for the PM4 pump. LOW BATTERY Remaining battery charge is 10 minutes. NEXT CARDIOPLEGIA DOSE IS DUE The time to next dose is elapsed and the clamp time is running. OXYGEN SATURATION: LOW VALUE Oxygen saturation value is lower than 50% and pump time is running. OVERPRESSURE: PR1 PR1 pressure is greater than the corresponding alert limit. OVERPRESSURE: PR2 PR2 pressure is greater than the corresponding alert limit. OVERPRESSURE: PR3 PR3 pressure is greater than the corresponding alert limit. OVERPRESSURE: PR4 PR4 pressure is greater than the corresponding alert limit. OVERPRESSURE: PR7 PR7 pressure is greater than the corresponding alert limit. OVERPRESSURE: PR8 PR8 pressure is greater than the corresponding alert limit. PM1 PUMP COVER OPEN PM1 pump cover is open. PM2 PUMP COVER OPEN PM2 pump cover is open. PM3 PUMP COVER OPEN PM3 pump cover is open. PM4 PUMP COVER OPEN PM4 pump cover is open. TOO MUCH AIR IN VARD: CHECK VACUUM Activated only in Auto Mode if air is detected in the VARD lower sensors and VARD Servo is enable. VARD: CABLE NOT CONNECTED VARD cable not connected. VARD: LOW SUCTION VARD Pressure (PR7) is less negative than -200 mm Hg. VARD: STAND-BY MODE VARD in Standby Mode. Operator’s Manual PerformerV1.5_EN_7.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Troubleshooting Alerts Message Description VARD: TUBE NOT INSERTED IN PINCH VALVE The system is not detecting the silastic tube in the pinch valve. OVERPRESSURE: PR5 PR5 (VLP in Resting Heart mode) pressure is greater than the corresponding alert limit. LEVEL SENSING DISABLED This alert condition occurs when: ■ 1 or 2 level sensor configuration is selected ■ level sensing is disabled LEVEL SENSORS ERROR This alert condition occurs when: ■ two-sensor configuration is selected ■ level sensing is disabled ■ high level sensor sees fluid ■ low level sensor sees air The cause of the problem could be: ■ fluid between high and low sensor WITH low and high sensor in the reverse position (low sensor above high sensor) ■ fluid above the high level sensor but the low sensor sees air--low sensor could be damaged LOW BLOOD LEVEL This alert condition occurs when the fluid level drops below the position of the yellow (alert) sensor on the reservoir. Operator’s Manual A14113002 Rev. 2.0 7-29 PerformerV1.5_EN_7.fm 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 7 Alerts 7-30 A14113002 Rev. 2.0 Operator’s Manual Medtronic Confidential CS0023 PerformerV1.5_EN_8.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Warranty 8 IMPORTANT NOTICE - LIMITED WARRANTY 8-2 IMPORTANT NOTICE - LIMITED WARRANTY 8-3 8 Operator’s Manual A14113002 Rev. 2.0 8-1 PerformerV1.5_EN_8.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 8 IMPORTANT NOTICE - LIMITED WARRANTY IMPORTANT NOTICE - LIMITED WARRANTY (U.S. Customers Only) MEDTRONIC, INC. INSTRUMENT LIMITED WARRANTY1 (U.S.) A. This LIMITED WARRANTY provides the following assurance to the purchaser of the Medtronic® Performer™ CPB Advanced Extracorporeal Circulatory Support System, hereafter referred to as the “Instrument”: (1) Should the Instrument fail to function within normal tolerances due to a defect in materials or workmanship within a period of one (1) year, commencing with the delivery of the Instrument to the purchaser, Medtronic will at its option: (a) repair or replace any defective part or parts of the Instrument; (b) issue a credit to the purchaser equal to the Purchase Price, as defined in Subsection A (2), against the purchase of the replacement Instrument; or (c) provide a functionally comparable replacement Instrument at no charge. (2) As used herein, Purchase Price shall mean the lesser of the net invoiced price of the original, or current functionally comparable, or replacement Instrument. B. To qualify for the repair, replacement or credit set forth in Section A, the following conditions must be met: (1) The Instrument must be returned to Medtronic within sixty (60) days after discovery of the defect (Medtronic may, at its option, repair the Instrument on site). (2) All installation, updates, modifications, and repairs to the Instrument must have been performed only by personnel authorized by Medtronic. (3) The Instrument must have been serviced, repaired, altered, or its internal components accessed only by persons or entities authorized by Medtronic to perform such work on the Instrument. (4) The Instrument must have been (i) operated only by personnel who have been properly trained in operation of the Instrument, (ii) operated only in accordance with the instructions given in the Operator's Manual for the Instrument, and (iii) subject to no misuse, abuse or accident. C. This LIMITED WARRANTY is limited to its express terms. In particular: (1) Except as expressly provided by this LIMITED WARRANTY, MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE OR MALFUNCTION OF THE INSTRUMENT, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT OR OTHERWISE. (2) This LIMITED WARRANTY is made only to the purchaser of the Instrument. AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM OR OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON. 1 8-2 A14113002 Rev. 2.0 This Limited Warranty is provided by Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604. It applies only in the United States. Areas outside the United States should contact their local Medtronic® representative for exact terms of the Limited Warranty. Operator’s Manual PerformerV1.5_EN_8.fm Medtronic Confidential CS017 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Warranty IMPORTANT NOTICE - LIMITED WARRANTY (3) The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this LIMITED WARRANTY is held to be illegal, unenforceable or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid. This LIMITED WARRANTY gives the purchaser specific legal rights. The purchaser may also have other rights which vary from state to state. (4) No person has any authority to bind Medtronic to any representation, condition or warranty except this Limited Warranty. IMPORTANT NOTICE - LIMITED WARRANTY (For Countries Outside the U.S.) THE FOLLOWING LIMITED WARRANTY APPLIES TO CUSTOMERS OUTSIDE THE UNITED STATES. A. This LIMITED WARRANTY provides the following assurance to the purchaser of the Medtronic® Performer™ CPB Advanced Extracorporeal Circulatory Support System, hereafter referred to as the “Equipment” that should the Equipment fail to function within normal tolerances due to a defect in materials or workmanship within a period of one (1) year commencing with the delivery of the Equipment to the purchaser, Medtronic will at its option: (a) repair or replace any defective part or parts of the Equipment; (b) issue a credit equal to the original Equipment purchase price (but not to exceed the value of the replacement Equipment), against the purchase of replacement Equipment, or (c) provide functionally comparable replacement Equipment at no charge. B. To qualify for this repair, replacement or credit set forth in Section A, the following conditions must be met: (1) The Equipment must be returned to Medtronic within sixty (60) days after discovery of the defect, (Medtronic may, at its option, repair the Equipment on site). (2) All installation, updates, modifications, and repairs to the Equipment must have been performed only by personnel authorized by Medtronic. (3) The Equipment must have been serviced, repaired, altered, or its internal components accessed only by persons or entities authorized by Medtronic to perform such work on the Equipment. (4) The Equipment must have been (i) operated only by personnel who have been properly trained in operation of the Equipment, (ii) operated only in accordance with the instructions given in the Operator's Manual for the Equipment, and (iii) subject to no misuse, abuse or accident. C. This LIMITED WARRANTY is limited to its express terms. In particular, Medtronic is not responsible for any incidental or consequential damages based on any use, defect or failure of the Equipment, whether the claim is based on warranty, contract, tort or otherwise. Operator’s Manual A14113002 Rev. 2.0 8-3 PerformerV1.5_EN_8.fm Medtronic Confidential CS0023 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Chapter 8 IMPORTANT NOTICE - LIMITED WARRANTY D. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. If any part or term of this LIMITED WARRANTY is held by any court of competent jurisdiction to be illegal, unenforceable or in conflict with applicable law, the validity of the remaining portion of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid. E. No person has any authority to bind Medtronic to any representation, condition or warranty except this Limited Warranty. 8-4 A14113002 Rev. 2.0 Operator’s Manual PerformerV1.5_Rev1IX.fm 3/4/08 Medtronic Confidential CS017 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Index A A A Loss or Failure 7-15 Warnings 1-7 AAR Controller Operation 5-60 Overview 5-58 Run Screen 5-58 Warnings 1-6 Bio-Console 1-5 Bio-Pump 1-2, 1-3 Backflow Detected 7-19 Bio-Pump Configuration 5-105 Cautions 1-9 Connection site 5-15 Control Panel 5-3, 5-5 Failure 7-17 Indications for Use 1-5 Options Menu Screen 5-94 Pump Speed RPM Knob 5-5, 5-106 Response Definitions 5-27, 5-98 Safety System Events 5-24, 5-97 Setup Button 5-38 To Assign Pump Responses 5-24 Warnings 1-8 Air Bubble Detection 5-64, 5-65, 7-15 Safety System 7-5 Transducers 5-63 Air Bubble Detector 3-4, 5-15, 5-42, 7-4 Alerts 7-27 Warnings 1-8 Air Detection 1-3, 5-63 Alerts and Alarms 5-56 Warnings 1-5 Alarms 5-40, 7-2, 7-20 Cardioplegia Delivery Air Detection Alerts and Alarms 5-56 High Pressure Condition 5-87 Priority of Alarms 7-3 Resetting 7-3 Self-Resetting Alarms 7-4 Simultaneous Activation of Alarms/Alerts 7-2 VLP 5-106 Alerts 5-40, 7-2, 7-27 Cardioplegia Delivery Air Detection Alerts and Alarms 5-56 High Pressure Condition 5-87 Simultaneous Activation of Alarms/Alerts 7-2 VLP 5-106 Arterial Line ABD System 5-63 Setup and Operation 5-63 Blood Drug Ratio 5-50 C Calibration 2-3 Cardiac Index 1-4, 5-42, 5-102 Cardioplegia Circuit and Delivery Parameters 5-53 Delivery 5-54 Delivery Air Detection Alerts and Alarms 5-56 Dose Settings 5-51 Manual Mode 5-51 Time Mode 5-51 Volume Mode 5-51 During Cardioplegia Infusion 5-55 Volume and Time Tracking 5-52 Arterial Line Pressure Sensor 5-14 Castor Brake and Unbrake Switches 5-2 AutoClamp System 3-6, 5-73 Cautions 1-9 Auxiliary Timer 5-48 Central Information Display (CID) 1-2, 1-3, 5-3 B Battery 1-4, 2-2, 3-5, 3-11, 5-3, 5-111, 7-15 Disposal 2-4 Cautions 1-9 Failure 7-15 Warnings 1-5 Clamp Timer Operator’s Manual A14113002 Rev. 2.0 A-1 PerformerV1.5_Rev1IX.fm 3/4/08 Medtronic Confidential CS0023 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Operation 5-46 Cleaning 6-2 G Grounding Equalization Post 5-2 General Data 3-2 Configuration Acoustic Signals 5-30 Date and Time 5-32 General Data 5-28 Language 5-31 Password 5-31 Pressure Transducers 5-20 Roller Pumps 5-20 Safety Systems 5-21 Saving Configuration Settings 5-32 Service Settings 5-32 Software Version 5-32 Temperature Channels 5-20 Console Up and Down Switches 5-2 Contraindications 1-5 D H Handcrank 5-7 Manual Operation 5-8 Warnings 1-8 Hematocrit 1-4, 5-42 Monitoring 1-3, 3-10, 5-90 Home Button 5-38 HTS Module 3-10, 5-54, 5-90 I Installation 4-2 L Defibrillator Warnings 1-5 Delivery Mode 5-49 One-Pump 5-40, 5-49 Selection 5-49 Two-Pump 5-40, 5-49 LEMO® Connector 5-60, 5-61 Level Sensing System 3-6, 5-67 M Main Power Supply Failure 2-2, 3-11 Description 1-2 Dynamic Function Buttons 5-38 Main Power Switch 5-2 E Main Run Screen 5-41 Emergency Procedures 7-4 Maintenance 6-2 Equipotential Connection 2-4 Manual Mode 5-51, 5-55 Events Log 5-103 Memory Card 5-111 Button 5-38 Icons 5-103 Screens 5-103 External Communication Interface 3-5 External Devices Connector Panel 5-15 Install 5-15 Warnings 1-5 Menu Bar 5-19 Mounting Flanges 5-14 O F Flow Display 5-5 Flow Meter 3-4 Connection site 5-15 Fluid-In-Line Sensor 3-5, 5-59 AAR FIL Sensor 5-14 Fuse/Circuit Breakers 5-2 External fuses 3-2 Replacement 2-3 A-2 A14113002 Warnings 1-7 Rev. 2.0 Operator’s Manual O2 Saturation 3-10 Options Menu Screen 5-94 P Password 5-16, 5-30, 5-31 Configuration 5-31 Protection 5-18 Patient Information 5-100 Button 5-38 Entry of Information 5-100 PerformerV1.5_Rev1IX.fm 3/4/08 Medtronic Confidential CS017 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Power Cord 5-2 Time Mode 5-51 Power On Self-Test 5-17 Time Since Last Dose 5-52, 5-55, 5-56 Warnings 1-8 Pressure Mode Selection 5-84 Time to Next Dose 5-52, 5-55, 5-56 Trending 1-4, 5-101 Pressure Transducers 1-4 Configuration 5-20 Zeroing 5-87 Parameters and Y-Axis Ranges 5-102 Screens 5-101 Tube Inserts 5-9 Pressures 3-4 Trending 5-101 Installing 5-9 Tubing 5-11 Preview Buttons 5-50 Loading 5-11 Mechanical Loading Feature 5-13 Warnings 1-8 Printer 3-5, 5-103 Printed Report 5-104 Pump Timer Operation 5-46 Overview 5-46 R U Uninterruptible Power Supply 3-5, 3-11 Warnings 1-5 User Interface 5-64 Setup 5-64 Read-Only Screen Graphics 5-37 Roller Insert 5-7 Installing 5-7 Removing 5-7 Setting the Roller Pump Speed 5-7 V VARD 1-4 Operation 5-60 Overview 5-58 Run Screen 5-58 Roller Pumps 5-3, 5-6 Control Panel 5-3 PM1 1-2, 3-3, 5-3 PM2 1-2, 3-3, 5-4 PM3 1-2, 3-3, 5-4 PM4 1-2, 3-4 Response Definitions 5-27, 5-98 Setup 5-95 Warnings 1-8 Venous Line Pressure Sensor 5-14 Venous Line Pressure Servo 5-104 Activating 5-105 Alert and Alarm Conditions 5-106 Volume Mode 5-51 Volume Tracking 5-50 S W Safety Standards 2-2 Warnings 1-5 Safety System 5-96 Warranty 8-2 Assigning Pump Responses 5-24 Configuration 5-21 Configuration Edit Screens 5-96 Start Timers 5-46 Static Function Buttons 5-19, 5-37 Stop Timers 5-47 System Configuration 5-16 T Temperature 5-100 Monitoring 1-3, 5-42, 5-54 Trending 5-101 Time Between Doses 5-55 Operator’s Manual A14113002 Rev. 2.0 A-3 PerformerV1.5_Rev1IX.fm 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) A-4 A14113002 Rev. 2.0 Operator’s Manual Medtronic Confidential CS0023 PerformerV1.5_bcv.fm 3/4/08 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) A14113002 Rev. 2.0 Medtronic Confidential CS017 PerformerV1.5_bcv.fm 3/4/08 Medtronic Confidential CS017 3:05 pm 8.5 in x 11.0 in (215.9 mm x 279.4 mm) Manufacturer RanD S.r.l. Via Statale 12, 62 41036 Medolla (MO) Italy Internet: www.rand-biotech.com Tel. 39-0535-49283 Fax 39-0535-660636 Asia Medtronic International Ltd. Suite 1602 16/F, Manulife Plaza The Lee Gardens, 33 Hysan Avenue Causeway Bay Hong Kong Tel. 852-2891-4068 Fax 852-2591-0313 Europe Europe/Africa/Middle East Headquarters Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Switzerland Internet: www.medtronic.co.uk Tel. 41-21-802-7000 Fax 41-21-802-7900 Medtronic E.C. Authorized Representative / Distributed by Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. 31-45-566-8000 Fax 31-45-566-8668 Asia-Pacific Japan Medtronic Japan Comodio Shiodome 5F 2-14-1 Higashi-Shimbashi, Minato-ku Tokyo 105-0021 Japan Tel. 81-3-6430-2001 Fax 81-3-6430-7140 Americas Latin America Medtronic Latin America 3750 NW 87th Avenue Suite 700 Miami, FL 33178 Tel. 305-500-9328 Fax 786-709-4244 Canada Medtronic of Canada Ltd. 6733 Kitimat Road Mississauga, Ontario L5N 1W3 Tel. 905-826-6020 Fax 905-826-6620 Toll-free in Canada: 1-800-268-5346 United States Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Internet: www.medtronic.com or www.perfusionsystems.com Tel. 763-391-9000 Fax 763-391-9100 Australia Medtronic Australasia Pty. Ltd. Business Address: 97 Waterloo Road North Ryde NSW 2113 Mailing Address: PO Box 945 North Ryde NSW 1670 Australia Tel. 61-2-9857-9000 Fax 61-2-9878-5100 © Medtronic, Inc. 2006, 2008 A14113002 Rev. 2.0 A14113002 Rev. 2.0 *A14113002*
advertisement
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project