RECOVER BP IABP/VAD System Operator’s Manual ®
RECOVER BP IABP/VAD System Operator’s Manual ABIOMED, Inc. 22 Cherry Hill Drive Danvers, MA 01923 USA 978-777-5410 978-777-8411 (fax) clinical@abiomed.com (email) www.abiomed.com 24-Hour Emergency Hotline: N. America 1-800-422-8666 September 2006 DRAFT Document No. x Rev.
IMPORTANT NOTICE: Read this entire manual before using the RECOVER BP IABP/VAD System. The RECOVER BP IABP/VAD System is to be used only in accordance with this manual and in conjunction with the RECOVER BP Intra-Aortic Balloon Catheter Instructions for Use ****[document number]. Information contained in this document is subject to change without notice. © 2006 ABIOMED, Inc. All rights reserved. ABIOMED is a trademark of ABIOMED, Inc. and is registered in the U.S.A.
Contents Introduction ........................................................................ ix 1 Warnings and Cautions ................................................ 1.1 Warnings...................................................................................................................... 1.2 Cautions....................................................................................................................... 1.5 2 Indications, Contraindications, and Potential Adverse Events .........
System Menu ............................................................................................................... 5.3 Checking Console Power Status.................................................................................. 5.4 6 IABP Support ................................................................ 6.1 Using the Interface ....................................................................................................... 6.2 IABP Keypad...........................................
Optimizing AB5000 Ventricle Filling ...................................................................... 7.5 Adjusting Vacuum Level ....................................................................................... 7.6 To Stop Pumping .................................................................................................. 7.8 Weaning................................................................................................................ 7.8 Adjusting the Low Flow Alarm Level ........
10 Installation and Maintenance ................................... 10.1 Installation .................................................................................................................. 10.2 Checking the Console Before Each Use .................................................................... 10.2 Periodic Testing of Backup Systems.......................................................................... 10.3 Testing the Hand Pump .........................................................
Figure 15 Figure 16 Figure 17 Figure 18 Figure 19 Figure 20 Figure 21 Figure 22 Figure 23 Figure 24 Figure 25 Figure 26 Figure 27 Figure 28 Figure 29 Figure 30 Figure 31 Figure 32 Figure 33 System Menu ........................................................................................5.3 IABP Keypad .........................................................................................6.2 IABP Screen..........................................................................................6.
Introduction This manual provides instructions for operating the RECOVER BP IABP/VAD System (RECOVER BP System or System). It is intended to be used in conjunction with the RECOVER BP Intra-Aortic Balloon Catheter Instructions for Use ****[add document number]. The following information summarizes the contents of each section: • Section 1 (Warnings and Cautions) lists the warnings and cautions pertaining to the use of the RECOVER BP System.
1 Warnings and Cautions Contents Warnings................................................................................................................ 1.2 Cautions................................................................................................................. 1.5 1.
1 Warnings and Cautions Warnings Warnings NOTE: A warning indicates a situation that could result in injury or death. • The RECOVER BP System is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. It is also not suitable for use in an oxygen-enriched atmosphere. • The RECOVER BP Console does not contain any user-serviceable parts.
Warnings and Cautions 1 Warnings • Per IEC 60601-1-1: Patient leakage current must NOT exceed 0.01 mA. • Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the Electromagnetic Compatibility (EMC) information provided in the accompanying documents. • Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.
1 Warnings and Cautions Warnings 1.4 • If the heart rate varies by more than 10 beats per minute (bpm) within X seconds, evaluate inflation and deflation timing and make adjustments if necessary. • Pumping an IAB that has a leak can result in: (1) a blood clot in the IAB that may require surgical removal of the IAB, and (2) air embolism. • Due to the potential for thrombus formation, an IAB must NOT remain dormant. • Do NOT place an IAB patient in a hyperbaric chamber.
Warnings and Cautions 1 Cautions Cautions NOTE: A caution indicates a situation in which equipment may malfunction, be damaged, or cease to operate. • The RECOVER BP Console must be plugged into AC power to maintain a charged battery. • To remove all AC power from the Console, unplug the power cord from the AC outlet. • Be sure to route the power cord and all cables, including the keypad/display extension cable, in a manner which prevents tripping hazards and equipment damage.
1 Warnings and Cautions Cautions 1.6 • Do NOT power the RECOVER BP System using Multiple Portable Socket Outlets (MPSO) or an extension cord. • Do NOT allow the conductive parts of electrodes and associated connectors to contact any conductive parts and/or earth ground. • Do NOT use a RECOVER BP System if any part of the System is damaged. • Do NOT use damaged or contaminated connector cables.
2 Indications, Contraindications, and Potential Adverse Events Contents Indications.............................................................................................................. 2.2 IABP................................................................................................................ 2.2 VAD ................................................................................................................ 2.2 Contraindications ......................................................
2 Indications, Contraindications, and Potential Adverse Events Indications Indications IABP • Cardiogenic shock • Unstable angina • Acute myocardial infarction (AMI) • Complications following MI • Adjunct to **** (PTCA) • Adjunct to cardiac catheterization • Bridge to transplant • Hemodynamic support pre-, intra-, and post-operatively • Bridge to other therapies • Intractable arrhythmias VAD ABIOMED® RECOVER BP Circulatory Support System (CSS) therapy is intended to treat patients suffe
Indications, Contraindications, and Potential Adverse Events 2 Indications Appropriate patient groups include those that are likely to recover cardiac function after the myocardium is permitted to rest on ventricular support. Examples include, but are not limited to: • Patients who fail to wean from cardiopulmonary bypass (CPB) following heart surgery. • Failed transplant patients who require ventricular assist following heart transplantation.
2 Indications, Contraindications, and Potential Adverse Events Contraindications Contraindications IABP • Significant aortic valve insufficiency • Thoracic or abdominal aortic aneurysm • Severe **** (PVD) • Occluded aorta VAD • Major cardiac or extracardiac catastrophes occurring during operation or in the postoperative period that preclude survival such as uncontrolled hemorrhage, massive air embolization, interstitial pulmonary hemorrhage with inability to maintain adequate ventilation, pump oxy
3 The RECOVER BP IABP/VAD System Contents Overview................................................................................................................ 3.2 Disposables and Accessories ................................................................................ 3.3 IABP................................................................................................................ 3.3 VAD .........................................................................................................
3 The RECOVER BP IABP/VAD System O ve r vi ew Overview The RECOVER BP IABP/VAD System (RECOVER BP System) is a versatile cardiac assist device that combines IABP and VAD support capability within one Console (described in Section 4). This mobile System uses a laptop-style interface. Laptop-style Interface Console Cart Figure 1 RECOVER BP Console 3.
T h e R E C O V E R B P I A B P / V A D S ys t e m 3 D i s p o s a b l e s a n d Ac c e s s o r i e s Disposables and Accessories WARNING: Do NOT reuse single-use devices. IABP For IABP support (described in Section 6), the following items are used with the RECOVER BP System: • 8F 40 cc IAB Catheter Kit (see Figure 2) Figure 2 IAB Catheter Kit RECOVER BP IABP/VAD System – Operator’s Manual 3.
3 The RECOVER BP IABP/VAD System D i s p o s a b l e s a n d Ac c e s s o r i e s • IAB Insertion Kit (see Figure 3) Figure 3 IAB Insertion Kit • Patient Cable Set • Helium Cylinder • Chart Recorder Paper • Adapter for Datascope® 8F (40 cc) IAB Catheter VAD For VAD support (described in Section 7), the following items are used with the RECOVER BP System: • 3.4 AB5000™ Ventricle (Ventricle) – a pneumatically driven device that provides pulsatile, hemodynamic support (see Figure 4).
T h e R E C O V E R B P I A B P / V A D S ys t e m 3 D i s p o s a b l e s a n d Ac c e s s o r i e s Figure 4 AB5000™ Ventricle • BVS® Blood Pump (BVS Pump) – a pneumatically driven device that provides pulsatile, hemodynamic support (see Figure 5). The dual-chamber BVS Pump provides circulatory support in the presence of left-, right-, or both-sided heart failure. It can operate either vertically or horizontally and its atrial chamber fills passively.
4 Using the RECOVER BP Console Contents Overview................................................................................................................ 4.2 Key Features ......................................................................................................... 4.3 Console Electrical Connections ............................................................................. 4.6 Keypad Layout ...............................................................................................
4 Using the RECOVER BP Console O ve r vi ew Overview The following pages present a general overview of Console features, electrical connections, and interface layout. For operating instructions, refer to IABP Support (Section 6) and VAD Support (Section 7). These sections contain detailed instructions and task-specific information. 4.
Using the RECOVER BP Console 4 Key Features Key Features The key mechanical features of the Console are shown in Figures 6, 7, and 8. Tables 1, 2, and 3 describe the function of each feature. Keypad and Display Right Driveline Connector Left Driveline Connector Power Status Indicators Figure 6 Console Features: Front View Table 1 Console Feature Descriptions: Front View Feature Description Keypad and Display Laptop-style user interface used to monitor and control both VAD and IABP functions.
4 Using the RECOVER BP Console Key Features Doppler Compartment IV Pole IAB Connector Cooling Vents Chart Recorder Cover Helium Cylinder Compartment Connection Panel Figure 7 Console Features: Right-Side View Table 2 Console Feature Descriptions: Right-Side View Feature Description Doppler Detects arterial blood flow. ® 4.4 IV Pole (for BVS Blood Pump only) Provides support for 2 BVS Blood Pumps. IAB Connector Connection point for the IAB Catheter extender.
Using the RECOVER BP Console 4 Key Features Cooling Vents Hand Pump Power Switch Potential Equalization Terminal Figure 8 Console Features: Left-Side View Table 3 Console Feature Descriptions: Left-Side View Feature Description Power Switch Switch to turn the Console ON or OFF. Potential Equalization Terminal Conductor for providing connection to the potential equalization busbar of the installation. Hand Pump Allows manual operation of an AB5000 Ventricle or a BVS® Blood Pump.
4 Using the RECOVER BP Console Console Electrical Connections Console Electrical Connections Electrical connections to the Console are made at the right-side panel. The connections are shown in Figure 9 and briefly described in Table 4. Each connector is unique and keyed to ensure that connections are made correctly.
Using the RECOVER BP Console 4 Keypad Layout Keypad Layout The keypad is used in conjunction with the display to control and monitor the IABP and VAD functions of the Console. The keypad is divided into three sections (see Figure 10): • Intra-Aortic Balloon Pump – for performing IABP support (see Section 6 for detailed descriptions of key functions). • System – for handling tasks common to both IABP and VAD support (see Section 5). • Ventricular Assist – for performing VAD support (see Section 7).
4 Using the RECOVER BP Console Display Layout Display Layout The Console display is a color LCD monitor that can be tilted to achieve a comfortable viewing angle. You can swivel the keypad and display unit in either direction, and the entire keypad/display unit detaches for portable use while remaining connected to the Console by a coiled cable. The Console uses separate menus and screens for IABP and VAD support.
Using the RECOVER BP Console 4 Display Layout Table 5 Menu Structure IABP Menu (see Section 6 for more information) ECG Source (I, II, III, aVR, aVL, aVF, External) ECG Gain (Auto, 0.5X, 0.75X, 1.0X, 1.25X, 1.5X, 2.0X, 3.
4 Using the RECOVER BP Console Display Layout Table 5 Menu Structure (continued) VAD Menu (see Section 7 for more information) Left Low Flow Alarm Threshold Right Low Flow Alarm Threshold BSA System Menu Print Menu Waveforms (ECG/AP, ECG/BP, AP/BP, ECG, AP, BP) Speed (25 mm/sec, 50 mm/sec) Strip Length (8 sec, 60 sec) Auto Print (Off, 1 min, 5 min, 30 min, 1 hr, 2 hr) Console Mode Brightness Control (1–10) Audio Level (High, Medium, Low) Date & Time (MM/DD/YY)(HH:MM) Language (English) IP Address (nnn.nnn.
Using the RECOVER BP Console 4 Display Layout Sample Screens Figure 12 (IABP) and Figure 13 (VAD) show samples of Console screens. Figure 12 Sample IABP Screen RECOVER BP IABP/VAD System – Operator’s Manual 4.
4 Using the RECOVER BP Console Display Layout Figure 13 Sample VAD Screen 4.
5 System Status and Settings Contents Using the Interface................................................................................................. 5.2 System Menu ......................................................................................................... 5.3 Checking Console Power Status............................................................................ 5.4 5.
5 S ys t e m S t a t u s a n d S e t t i n g s Using the Interface Using the Interface SYSTEM The System section of the keypad (see Figure 14) is used for handling tasks common to both IABP and VAD support. These indicators and controls are described in Table 6. Figure 14 System Keypad Table 6 System Keypad Functions Feature Use Indicator Lights EMERGENCY SYSTEM ON Red light flashes when the Emergency System is operating. Refer to Section 8 for more information.
S ys t e m S t a t u s a n d S e t t i n g s 5 System Menu System Menu The System menu (see Figure 15) is located on both the IABP menu and the VAD menu. The menu structure is shown in Table 7.
5 S ys t e m S t a t u s a n d S e t t i n g s C h e c k i n g C o n s o l e P ow e r S t a t u s Checking Console Power Status The Console runs on either AC power or its internal battery. It continuously charges the battery, which requires approximately 16 hours to recharge after depletion, while it is plugged into AC power. A fully charged battery will power the Console for one hour.
S ys t e m S t a t u s a n d S e t t i n g s 5 C h e c k i n g C o n s o l e P ow e r S t a t u s Table 8 Power Status Indicated by the IABP and VAD Screens Battery Icon AC Power Icon Meaning Console is using AC power (halo showing). Console Battery is fully charged (all segments filled) but not in use (no halo). Using Battery power. Battery is fully charged. AC power is unplugged. Using Battery power. Battery is about ¾ charged. AC power is unplugged. Using AC power. Battery is about ½ charged.
6 IABP Support Contents Using the Interface................................................................................................. 6.2 IABP Keypad .................................................................................................. 6.2 IABP Screen ................................................................................................... 6.4 Initial Setup ............................................................................................................ 6.
6 IABP Support Using the Interface Using the Interface IABP Keypad The IABP section of the keypad (see Figure 16) contains controls and indicators for handling the tasks involved in IABP support. The functions of these keys are described in Table 10. TRIGGER SO URCE INFL ATION DEFLATION Figure 16 IABP Keypad 6.
IABP Support 6 Using the Interface Table 10 IABP Keypad Functions Feature Use Control Keys ON Purges the pneumatic system and starts pumping. STANDBY Pauses pumping but keeps the Console ready to immediately resume pumping. Pumping resumes when ON is pressed. OFF Stops pumping when pressed twice within 13 seconds. AUTO Automatically selects optimal ECG source, ECG gain, AP source, trigger source, inflation timing, and deflation timing.
6 IABP Support Using the Interface IABP Screen The IABP screen (see Figure 17) enables you to monitor all aspects of IABP operation. This screen also supplies patient information. These display elements are described in Table 11. A T B S R C Q P O D N M E L F G K H J I Figure 17 IABP Screen 6.
IABP Support 6 Using the Interface Table 11 IABP Screen Descriptions Item Display Element Description A Alarm Messages Highest priority active alarms (3 maximum). Highest priority alarm is at the top of the list. Refer to "IABP Alarms" in this Section for more information. B Heart rate Current heart rate in beats per minute (bpm); green text. C Systolic pressure Red text; unassisted below in smaller text; mmHg.
6 IABP Support Initial Setup Initial Setup WARNING: Do NOT power the RECOVER BP System using Multiple Portable Socket Outlets (MPSO) or an extension cord. WARNING: Pumping an IAB that has a leak can result in: (1) a blood clot in the IAB that may require surgical removal of the IAB, and (2) air embolism. WARNING: A patient monitor must be provided and used to continuously monitor patient physiological pressure. Do NOT rely solely on the System alarms to notify you of life-threatening conditions.
IABP Support 6 Initial Setup NOTE: If the helium cylinder pressure is less than ****[X] psi, change the cylinder by following the steps in "Replacing the Helium Cylinder" in this Section. Acquiring an Electrocardiograph (ECG) Waveform WARNING: Do NOT allow the conductive parts of electrodes and associated connectors to contact any conductive parts and/or earth ground. Acquiring a high-quality electrocardiograph (ECG) waveform is an important factor in achieving optimal triggering.
6 IABP Support Initial Setup 3 Connect the patient ECG cable to the green ECG input connector on the side panel of the Console. 4 Press the INFLATION MARKER key. 5 Check that the ECG waveform and heart rate are shown on the display. Using an External Monitor 1 Connect the interface cable to the ECG high-level patient monitor input on the side panel. 2 Check that the heart rate is shown on the upper right side of the display. 3 Press the INFLATION MARKER key.
IABP Support 6 Initial Setup 1 Place a pressure catheter at the chosen location. 2 Connect the pressure catheter to the pressure transducer. 3 Zero the pressure transducer by pressing ZERO on the System keypad. 4 Check that the peak and mean systolic/diastolic pressures are displayed. Check that the arterial pressure waveform is displayed after the IAB is inserted.
6 IABP Support Initiating Support Initiating Support WARNING: Due to the potential for thrombus formation, an IAB must NOT remain dormant. You can initiate support in either Auto or Manual mode. The appropriate mode depends on whether ease-of-use or flexibility is needed.
IABP Support 6 Initiating Support To Initiate Support in Manual Mode: WARNING: Due to the potential for thrombus formation, an IAB must NOT remain dormant. 1 Select “Manual” on the IABP keypad.
6 IABP Support Initiating Support 2 RA Attach electrodes to the patient as shown in the figures below. RA LA V LA C RL LL RL Electrode Locations (AHA) Electrode Locations (IEC) 3 Connect the patient ECG cable to the green ECG input connector on the side panel of the Console. 4 Press the MENU key and select ECG Source from the IABP menu. Select the desired ECG source (see Figure 20). The left side of the display shows the selected source. Figure 20 Selecting the ECG Source 6.
IABP Support 6 Initiating Support 5 Press MENU and select ECG Gain. Select the desired gain (see Figure 21). The left side of the display shows the selected ECG gain. Figure 21 Selecting the ECG Gain 6 Check that the ECG waveform and heart rate are shown on the display. Using an External Monitor 1 Connect the interface cable to the ECG monitor input on the side panel. 2 Press the MENU key and select ECG Source. Select the desired ECG source. The left side of the display shows the selected source.
6 IABP Support Initiating Support Setting the AP Source Using a Pressure Transducer NOTE: Refer to the Edwards Lifesciences Instructions for Use for important information on using the TruWave Disposable Pressure Transducer. Also refer to this document for volumetric displacement information. 1 Connect the transducer cable to the red AP connector on the side panel. 2 Press the MENU key and select AP Source > Direct (see Figure 22). The left side of the display shows the selected AP source.
IABP Support 6 Initiating Support Using an External Monitor 1 Connect the AP high-level input interface cable between the external patient monitor and the high-level AP input on the side panel. Make sure that ****[X] is selected on the display. 2 Press the MENU key and select AP Source > External (see Figure 23). The left side of the display shows the selected AP source. Figure 23 Selecting the AP Source for an External Monitor 3 Check that the arterial pressure waveform is properly displayed.
6 IABP Support Initiating Support Pressure WARNING: When pressure triggering is used, adjust deflation to be complete at the upstroke of systole. WARNING: Do NOT use pressure triggering while arrhythmia is present. The Console triggers on the arterial pressure waveform. Select this option under TRIGGER SOURCE on the keypad. Apace The Console triggers on a pacer. Select this option by choosing Other (under TRIGGER SOURCE) and then selecting Apace from the Trigger Source Other Selection menu.
IABP Support 6 Initiating Support Vpace The Console triggers on the ventricular waveform of the pacer. You can choose this option by selecting Other (under TRIGGER SOURCE) and then selecting Vpace from the Trigger Source Other Selection menu. Make sure that the pacemaker pulses are being detected by ****[X]. The Vpace signal must have an amplitude of ****[X] µV minimum and a pulse width of ****[X] ms minimum.
6 IABP Support Initiating Support Setting Inflation and Deflation Timing WARNING: If the heart rate varies by more than 10 beats per minute (bpm) within ****[X] seconds, evaluate inflation and deflation timing and make adjustments if necessary. 1 Press the ON key on the IABP keypad. The Console purges the IAB Catheter, fills the Catheter with helium, and begins pumping on the IAB.
IABP Support 6 I AB P Al a r m s IABP Alarms The Console monitors various functions to determine whether its operating parameters are within expected limits. When a parameter goes outside of its limits, the Console displays an alarm message and sounds an alarm tone. The severity of the alarm is indicated by the color of the alarm message and by the characteristics of the alarm tone.
6 IABP Support I AB P Al a r m s Alarm Messages Table 12 shows all IABP alarm messages. Table 12 IABP Red Alarm Messages RED ALARMS Alarm Message Category: Life-Threatening Possible Cause SYSTEM FAILURE • System failure. Change to Backup Console • Keypad not working/connected. Action 1. Change to backup Console. 2. Check keypad connection. 3. Call for service. PRESSURE LOW • Balloon rupture. Leak in Catheter / Driveline • Loose driveline connection. • Fluid in driveline.
IABP Support 6 I AB P Al a r m s Table 12 IABP Red Alarms (continued) RED ALARMS Alarm Message TRIGGER No Trigger Source Category: Life-Threatening Possible Cause • Unable to detect ECG or AP signal. Action 1. Check ECG leads/connection. 2. Check AP transducer/connection. TRIGGER No ECG Signal Detected • Unable to detect ECG signal. 1. Check ECG leads/connection. • Noise on ECG signal. 2. Limit movement of ECG cables. 3. Switch to Auto or AP mode.
6 IABP Support I AB P Al a r m s Table 13 IABP Yellow Alarm Messages YELLOW ALARMS Alarm Message TRIGGER Erratic Trigger Source Category: Serious Possible Cause • Noise on ECG or AP signal. Action 1. Check ECG leads/connection. 2. Limit movement of ECG leads. 3. Change to Auto or AP mode. TRIGGER ECG Detected AUGMENTATION Below Set-Limit • ECG activity detected. Change to Auto mode or ECG trigger source. • Patient hemodynamics. 1. Assess the patient. • Timing.
IABP Support 6 I AB P Al a r m s Table 14 IABP White Alarm Messages WHITE ALARMS Alarm Message LEAD OFF Category: Advisory Possible Cause • ECG lead off. Action 1. Check ECG leads. 2. Limit movement of ECG leads. ECG Electrode • Low helium cylinder pressure. Replace helium cylinder. SYSTEM • Out of paper. 1. Check paper. Chart Recorder • Door open. 2. Close door. HELIUM SUPPLY Low 3. Call for service. RECOVER BP IABP/VAD System – Operator’s Manual 6.
6 IABP Support I AB P Al a r m s Alarm Tone Characteristics The Console signals life-threatening and serious alarms using unique sounds (see Table 15). Table 15 Alarm Tone Characteristics Severity Level Description of Alarm Tone Life-Threatening Continuous beeps (4 times per second) Serious 4 beeps within 1 second; repeats every 5 seconds Alarm Silence Key Pressing the alarm silence key on the System keypad (see Figure 26) silences the alarm tone for approximately 1 minute.
IABP Support 6 Using the Doppler Weaning The patient should be weaned from IABP support per hospital protocol. Using the Doppler The Doppler unit used with the RECOVER BP System is the Koven EchoSounder™ ES-101EX. It is stored in a compartment at the back of the keypad base. To use the Doppler, follow these steps: 1 Open the compartment door and lift out the Doppler unit, which is tethered to the Console. 2 Turn the unit ON by pressing the power/freeze button.
6 IABP Support Using the Printer Using the Printer You can access various printing options by pressing the MENU key in the System section of the keypad and selecting System Menu > Print Menu. The following options are available: 6.
IABP Support 6 Replacing the Helium Cylinder Replacing the Helium Cylinder WARNING: Be sure to follow all warnings and cautions on the high-pressure gas (helium) cylinder. Observe all Department of Transportation (DOT) and International Air Transport Association (IATA) regulations for Dangerous Goods/Hazardous Materials when transporting a Console containing a helium cylinder. Only personnel trained in the handling of high-pressure gas cylinders should install or replace the helium cylinder.
6 IABP Support Replacing the Helium Cylinder 2 Turn the supply valve handle fully clockwise to close the cylinder valve (see Figure 28). Supply Valve Handle T-Handle Clamp Helium Cylinder Figure 28 Helium Cylinder Components 3 Tilt the cylinder at a slight angle (see Figure 29). Support the cylinder and slowly turn the T-handle clamp (see Figure 28) counterclockwise to loosen it. Figure 29 Tilting the Helium Cylinder 6.
IABP Support 6 Replacing the Helium Cylinder 4 Slowly remove the cylinder. Remove the sealing washer, inspect the washer for damage (replace it with a new one if necessary), and place it back on the regulator. 5 Install the new cylinder and hand-tighten the T-handle clamp. Gently push the cylinder back into the compartment. 6 Open the supply valve by turning the handle counterclockwise one-half turn. 7 Close the cylinder compartment. RECOVER BP VAD/IABP System – Operator’s Manual 6.
7 VAD Support Contents Using the Interface................................................................................................. 7.2 VAD Keypad ................................................................................................... 7.2 VAD Screen .................................................................................................... 7.3 Using the AB5000™ Ventricle................................................................................. 7.4 Console Preparation ..
7 VAD Support Using the Interface Using the Interface VAD Keypad The elements of the Ventricular Assist section of the keypad (see Figure 30) are described in Table 16. LEFT RIGHT Figure 30 VAD Keypad Table 16 VAD Keypad Functions Feature Use Indicator Lights (LEFT and RIGHT) RATE Amber light flashes with each beat. ON Green light when ON is pressed. OFF Red light flashes when OFF is pressed once (pumping is not stopped).
VAD Support 7 Using the Interface VAD Screen The VAD screen (see Figure 31) allows you to monitor all aspects of VAD operation. These display elements are described in Table 17. A B J C D Check Blood Pump: -Disconnect or leak in drive line. Check Blood Pump: -Drive line or blood pump lines kinked or occluded. E I F H G Figure 31 VAD Screen Table 17 VAD Screen Descriptions Item Display Element Description A Flow Black text in normal operation; green text in wean mode.
7 VAD Support ™ U s i n g t h e AB 5 0 0 0 V e n t r i c l e The RECOVER BP System provides VAD support capability using either the AB5000™ Ventricle (Ventricle) or the BVS® Blood Pump (BVS Pump). The following sections describe the procedures for using each blood pump type. WARNING: A patient monitor must be provided and used to continuously monitor patient physiological pressure. Do NOT rely solely on the System alarms to notify you of life-threatening conditions.
VAD Support 7 ™ U s i n g t h e AB 5 0 0 0 V e n t r i c l e Recommended Cannulation Method Refer to the Cannula Instructions for Use (0506-9110). Pump Type Verification Be sure that “Ventricle” is displayed as the pump type. Initiating Support 1 Initiate support as described in the AB5000 Ventricle Instructions for Use and the AB5000 Ventricle Training Guide. 2 Begin pumping by pressing the ON key for the appropriate side (Left or Right).
7 VAD Support ™ U s i n g t h e AB 5 0 0 0 V e n t r i c l e Adjusting Vacuum Level Overview The Console applies a default level of 100 mmHg (1.9 psi) of vacuum during diastole unless the vacuum level has been adjusted. You can adjust the vacuum level from 35 to 100 mmHg (0.7 to 1.9 psi) (in 5 mmHg (0.1 psi) steps) whether pumping is ON or OFF. Reducing the vacuum level to 35 mmHg (0.7 psi) reduces the flow rate by as much as 2 L/min from the level achieved at 100 mmHg (1.9 psi).
VAD Support 7 ™ U s i n g t h e AB 5 0 0 0 V e n t r i c l e Adjusting the Vacuum Level with Pumping Off Upon power-up (after completing its Self-Test), the Console displays the following screen: ****[Figure] The... indicate that the vacuum level is set to the default level of 100 mmHg (1.9 psi). Press the pump ON button if no reduction in vacuum level is needed. ****[vacuum level adjustment] In the following example, the vacuum level has been set to 50 mmHg (1.
7 VAD Support ™ U s i n g t h e AB 5 0 0 0 V e n t r i c l e In the following example, a Ventricle is pumping on the left side. The vacuum setting is at the default 100 mmHg (1.9 psi) level. ****[Figure] ****[vacuum level adjustment] In the following example, a Ventricle is pumping on the left side with the vacuum level set to 35 mmHg (0.7 psi): ****[Figure] To Stop Pumping To stop pumping, press the appropriate ON button twice within 13 seconds.
VAD Support 7 ™ U s i n g t h e AB 5 0 0 0 V e n t r i c l e Remote Alarm Output The remote alarm output allows you to connect the Console to a remote call system. The remote alarm output jack is located on the right side of the Console and accepts a standard phone plug. The switch is normally open, but closes when an alarm is generated. This switch closure can be used to trigger an alarm via the remote call system.
7 VAD Support ® Using the BVS Blood Pump Using the BVS® Blood Pump WARNING: Do NOT power the RECOVER BP System using Multiple Portable Socket Outlets (MPSO) or an extension cord. Console Preparation 1 Plug the Console power cord into an AC outlet. 2 Turn the Console ON using the AC power switch on the left side. The Console goes through a Self-Test and is ready to use in approximately 25 seconds.
VAD Support 7 ® Using the BVS Blood Pump Optimizing BVS Pump Filling When the Console is operating in normal (full-flow) mode, flow rate should be greater than 2 L/min and typically ranges from 3 to 6 L/min. To optimize blood flow: 1 Be sure that the patient is appropriately hydrated, with filling pressures within normal ranges. If the patient is hypovolemic, administer fluids according to hospital protocol. 2 Observe the filling and emptying of the upper bladder.
7 VAD Support ® Using the BVS Blood Pump Attaching the BVS® IV Pole Mount to the IV pole 1 Unscrew the screw clamp enough to fit the clamp around the IV pole. 2 Tighten the screw clamp onto the IV pole by turning the black knob clockwise. 3 Adjust the height of the Pole Mount by turning the central adjustment lever counterclockwise one-half turn to loosen it, while holding the handle (the adjustment lever is now pointing up towards the 12 o’clock position).
VAD Support 7 ® Using the BVS Blood Pump 8 Turn the central adjustment lever clockwise, back to its original position, to secure the Pole Mount in place. Attaching the BVS Pump to the BVS® IV Pole Mount A long plastic plate is attached to the back of the BVS Pump. At the top of this plate, slightly above the upper inflow bladder, is a square back plate designed to slide into the Pump bracket.
7 VAD Support ® Using the BVS Blood Pump Adjusting the Low Flow Alarm Level The low flow alarm level can be adjusted when pumping is ON. It can be set to any level (in 0.1 L/min steps) between the current flow rate and 1.8 L/min during normal operation (1.5 L/min in the weaning mode). ****[Adjusting the alarm level] To Stop Pumping To stop pumping, press the appropriate OFF button twice within 13 seconds. You must press the button twice to stop the pump (see Figure ****X).
VAD Support 7 ® Using the BVS Blood Pump Preparing the Console for Intrahospital Transport Unplugging the power cord automatically activates battery operation. When ready for transport, unplug the power cord, and wind it around the cord wrap. The Console can be transported on its cart or removed from its cart and transported separately. To remove the Console from the cart, first disengage the Console latch (located on the bottom rear of the cart) by lifting and then pulling the latch handle.
7 VAD Support V AD Al a r m s VAD Alarms The Console monitors various functions to determine whether its operating parameters are within expected limits. When a parameter goes outside of its limits, the Console displays an alarm message and sounds an alarm tone. The severity of the alarm is indicated by the color of the alarm message text and by the characteristics of the alarm tone ****[verify details].
VAD Support 7 V AD Al a r m s VAD Alarm Messages and Help Text Tables 17 and 18 show all VAD alarm messages and help text. Table 18 VAD Red Alarm Messages and Help Text RED ALARMS Category: Life-Threatening Alarm Message Action Check Blood Pump: LOW FLOW 1. Obstruction of blood lines. 2. Blood Pump placed too high relative to atrium. 3. Inadequate blood volume. HIGH PRESSURE Internal pressure problem: 1. Obtain backup Console.
7 VAD Support V AD Al a r m s Table 19 VAD Yellow Alarm Messages and Help Text YELLOW ALARMS Category: Serious Alarm Message PUMP ID Pump ID Disconnected (displayed in help window) PUMP ID New Pump ID Detected (displayed in help window) Action Re-attach Ventricle electrical/pneumatic connector to Console. Check Ventricle electrical/pneumatic connector: 1. Turn pump OFF and then ON again to change pump type selected by Console. 7.
VAD Support 7 Using the Hand Pump Using the Hand Pump If the Console fails (stops pumping), the supplied RECOVER BP Hand Pump allows manual operation of the Ventricle or the BVS® Pump. The Hand Pump is stored on the side of the Console. The Hand Pump may be operated while mounted on the Console, or it may be removed and held during operation. Transferring to the Hand Pump 1 Turn off and unplug the Console. 2 Remove the Ventricle or BVS Pump driveline(s) from the Console connector.
7 VAD Support Using the Hand Pump 7.20 4 Begin pumping by pressing the ON key for the appropriate side (Left or Right). If both sides are being supported, press the Left ON key first. 5 If necessary, return the Hand Pump to the Console holder. 6 Contact service personnel as soon as possible to repair the failed Console.
8 Emergency System Operation (ESO) Contents ESO Enabled During IABP Support ....................................................................... 8.2 ESO Enabled During VAD Support........................................................................ 8.2 8.
8 Emergency System Operation (ESO) E S O E n a b l e d D u r i n g I AB P S u p p o r t The RECOVER BP Console monitors its operating parameters and automatically enables the Emergency System Operation (ESO) mode if a serious problem is detected. The effects on Console operation are dependent on whether IABP or VAD support is in progress. ESO Enabled During IABP Support When ESO is enabled, the Console performs the following actions: Stops IAB pumping. • Deflates and vents the IAB.
9 Clinical Considerations Contents Effects of Electrosurgical Equipment ..................................................................... 9.2 Effects of Defibrillation Equipment ......................................................................... 9.2 9.
9 Clinical Considerations Effects of Electrosurgical Equipment Effects of Electrosurgical Equipment The RECOVER BP Console may exhibit the following effects during the use of electrosurgical equipment: • Display becomes blank or distorted • Alarm sounds • Pumping stops or becomes erratic The display and the pumping function will resume normal operation within 10 seconds after the completion of electrosurgery.
10 Installation and Maintenance Contents Installation............................................................................................................ 10.2 Checking the Console Before Each Use.............................................................. 10.2 Periodic Testing of Backup Systems.................................................................... 10.3 Testing the Hand Pump ................................................................................ 10.3 Testing ESO .............
10 I n s t a l l a t i o n a n d M a i n t e n a n c e Installation Installation Prior to clinical use, installation and testing of the Console shall be performed by an authorized ABIOMED® Service Representative. CAUTION: The RECOVER BP Console must be plugged into AC power to maintain a charged battery. CAUTION: To remove all AC power from the Console, unplug the power cord from the AC outlet.
Installation and Maintenance 10 Periodic Testing of Backup Systems Periodic Testing of Backup Systems Regularly test the Console's backup systems, which are the Hand Pump and the Emergency System Operation (ESO) feature. Testing the Hand Pump Operate the Hand Pump handle through its full range of motion and verify that air audibly vents from the left and right driveline connectors. Testing ESO 1 Turn the Console ON. Within 30 seconds, simultaneously press both WEAN keys for at least 3 seconds.
10 I n s t a l l a t i o n a n d M a i n t e n a n c e Cleaning Cleaning CAUTION: Do NOT pour liquid, including cleaning solution, directly on any part of the Console. Doing so can cause electrical malfunction. If liquid is accidentally spilled on the Console, be sure to thoroughly dry the affected area. Wait at least 15 minutes, after drying, before turning the Console ON. Verify that the Self-Test runs and indicates that the unit is operating properly.
Installation and Maintenance 10 P r e ve n t i ve M a i n t e n a n c e Preventive Maintenance The following preventive maintenance items are to be performed only by an authorized ABIOMED® Service Representative. Table 20 Preventive Maintenance Intervals Component/Subsystem Interval Battery One calendar year Solenoid Valve 5000 hrs. operating time Proportional Valve 2500 hrs. operating time Compressor 2500 hrs. operating time IABP 5000 hrs.
10 I n s t a l l a t i o n a n d M a i n t e n a n c e Ordering Information Ordering Information Table 21 Ordering Information for RECOVER BP Console Catalog No. Language Nominal Voltage 0036-0000 English 120 VAC ****[?] English 230 VAC Table 22 Ordering Information for Parts Catalog No.
11 Symbol Descriptions Symbol Description "ON" (power) Symbol IPX1 Description Protected against dripping water Alarm silence Attention, consult instructions Equipotentiality Year of manufacture Remote alarm output SN Fuse REF "OFF" for a part of equipment LOT Type CF Equipment defibrillator-proof Serial number Part number Lot number Alternating current 11.
12 System Specifications Contents Console Mechanical............................................................................................. 12.2 Console Electrical ................................................................................................ 12.4 Equipment Design................................................................................................ 12.5 Equipment Classifications.................................................................................... 12.
12 S y s t e m S p e c i f i c a t i o n s Console Mechanical Console Mechanical ****[reformat] Attribute Specification Temperature Operating: Storage: 10°C to 40°C (50°F to 104°F) -15°C to 50°C (5°F to 122°F) Relative Humidity Operating: Storage: 30% to 75% 10% to 95%, noncondensing Atmospheric Pressure Operating: (1050 hPa) Storage: (1050 hPa) 8000 ft (750 hPa) to -1000 ft 18,000 ft (500 hPa) to -1000 ft Dimensions – Transport & Hospital Configuration Height: Width: Depth: Transport (w/o Car
S ys t e m S p e c i f i c a t i o n s 1 2 Console Mechanical Console Mechanical (continued) ****[reformat] Attribute Specification Displayed Flow Accuracy At altitudes between min/max range, flow accuracy is as follows: Left Side: ± 15% over the following ranges: Inflow Pressure 5 to 25 mmHg (0.1 to 0.5 psi) Outflow Pressure 60 to 90 mmHg (1.2 to 1.7 psi) Right Side: ± 15% over the following ranges: Inflow Pressure 5 to 15 mmHg (0.1 to 0.3 psi) Outflow Pressure 30 to 40 mmHg (0.6 to 0.
12 S y s t e m S p e c i f i c a t i o n s Console Electrical Console Electrical ****[reformat] Attribute Specification AC operation: 100 – 230 VAC (nominal); 50/60 Hz; 4 A Console Internal battery operation: 24.0 VDC (nominal); sealed lead-acid Lead Input Support: 5 Lead Cable (AAMI or IEC) Electrodes: RA, LA, LL, RL, V Sampled Leads: I, II, V’ Derived Leads: III, aVR, aVL, AVF, V Range: ± 300 mV (DC) ± 80 mV (AC) Frequency Response: 0.4 – 100 Hz (-3dB) ****[TBD] 0.6 – 85 Hz Minimum Input Impedance: 2.
S ys t e m S p e c i f i c a t i o n s 1 2 Equipment Design Equipment Design The RECOVER BP System is designed to comply with the requirements of the following standards: • IEC 60601-1: 1988 + A1:1991 + A2:1995 • IEC 60601-1-1: 2000 • IEC 60601-2-27: 1994 (First Edition) • IEC 60601-2-34: 2000 (Second Edition) R E C O V E R B P IABP/VAD System – Operator’s Manual 12.
12 S y s t e m S p e c i f i c a t i o n s Equipment Classifications Equipment Classifications Type of protection against electric shock IEC 60601-1: Class I and internally powered. Relies not only on basic insulation against shock but also includes additional protection. Accomplished by providing means for connecting the equipment to the protective earth conductor of the fixed wiring of the installation in a way that prevents accessible metal parts from becoming live if basic insulation fails.
S ys t e m S p e c i f i c a t i o n s 1 2 Electromagnetic Compatibility Federal Communications Commission (FCC) Notice This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by ABIOMED, Inc.
12 S y s t e m S p e c i f i c a t i o n s Electromagnetic Compatibility TABLE 201 Guidance and Manufacturer's Declaration – Emissions All Equipment and Systems The RECOVER BP Console is intended for use in the electromagnetic environment specified below. The customer or user of the RECOVER BP Console should ensure that it is used in such an environment.
S ys t e m S p e c i f i c a t i o n s 1 2 Electromagnetic Compatibility TABLE 202 Guidance and Manufacturer's Declaration – Immunity All Equipment and Systems The RECOVER BP Console is intended for use in the electromagnetic environment specified below. The customer or user of the RECOVER BP Console should ensure that it is used in such an environment.
12 S y s t e m S p e c i f i c a t i o n s Electromagnetic Compatibility TABLE 204 Guidance and Manufacturer's Declaration – Emissions Equipment and Systems that are NOT Life-Supporting The RECOVER BP Console is intended for use in the electromagnetic environment specified below. The customer or user of the RECOVER BP Console should ensure that it is used in such an environment.
S ys t e m S p e c i f i c a t i o n s 1 2 Electromagnetic Compatibility TABLE 206 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the RECOVER BP Console Equipment and Systems that are NOT LifeSupporting The RECOVER BP Console is intended for use in the electromagnetic environment in which radiated disturbances are controlled.
12 S y s t e m S p e c i f i c a t i o n s P a t i e n t E n vi r o n m e n t Patient Environment The RECOVER BP Console and the components of the RECOVER BP System are the only items approved for use within the patient environment defined in IEC 60601-1-1 and in the figure below. CONSOLE 1.5 m 1.5 m CONSOLE 1.5 m 12.12 RECOVER BP IABP/VAD System – Operator’s Manual 2.
® ABIOMED, Inc. 22 Cherry Hill Drive Danvers, MA 01923 USA 978-777-5410 978-777-8411 (fax) clinical@abiomed.com www.abiomed.com 24-Hour Emergency Hotline: N. America 1-800-422-8666 September 2006 DRAFT Document No. x Rev.
