BVS 5000i Operators Manual
Contents
1. 2 Depress ACTIVATE button while turning SELECT knob until desired flow is displayed 3 Release ACTIVATE button Battery Battery activated by disconnecting line cord provides approximately one hour of operation when charged With AC power on BATTERY CHARGING message is displayed if charge is less than 80 capacity ALARMS Alarm Messages LOW FLOW LOW PRESSURE LOW FLOW HIGH PRESSURE LOW FLOW EMERGENCY SYSTEM ON BATTERY ON LOW lt 10 min of battery power COMPLETE CONSOLE FAILURE continuous audible alarm BATTERY CHARGING LOW ABIOMED Inc 11 07 Probable Causes Obstruction of blood lines Blood Pump placed too high relative to atrium Inadequate blood volume Disconnection or leak in air line Air line or blood pump lines kinked or occluded Microprocessor system failure obtain backup BVS console Low batteries plug machine in or obtain backup BVS console Remove foot pump located in rear compartment and continue pumping by foot while observing blood pump s Obtain backup BVS console Battery charging fault obtain backup BVS console page 31 This page left blank intentionally ABIOMED Inc page 32 11 07 ABIOMED Inc BVS 5000 DOMESTIC LIMITED SERVICE WARRANTY ABIOMED Inc warrants that at the time of installation all BVS 50007 consoles the Goods sold will be free from defects in material and workmanship and remain free from defects under normal use and service for a per2. Self Test Messages Action SELF TEST FAILED Do not use system Get backup console Contact qualified service personnel Section 5 2 Visual Audio check of machine functions Look and listen CHECK AUDIBLE SIGNALS or Section 5 2 CHECK ALARM AND STATUS LAMPS or CHECK FOR PROPER VALVE ACTUATION Normal Pumping Messages Action LEFT RIGHT SYSTEM Refer to Section 5 2 READY FOR USE LEFT RIGHT RATE XXX BPM Refer to Section 5 6 OUTFLOW XX X L M TO STOP PUMPING Refer to Section 5 6 3 PRESS OFF AGAIN Weaning Messages Action To set flow press and hold ACTIVATE Refer to Section 5 8 1 Turn SELECT to set flow XX X L M Refer to Section 5 8 1 LEFT RIGHT RATE XXX BPM Refer to Section 5 8 1 WEANING XX X L M Not enough flow Turning off weaning select knob TURN OFF WEANING Alarm Messages Action LOW FLOW Check hoses for leaks or kinks Section 6 2 LOW PRESSURE HIGH PRESSURE WARNING FOOT PUMP HANDLE Swing down transfer lever IS DISLODGED SYSTEM FAILURE Get backup console ABIOMED Inc page 29 11 07 This page left blank intentionally ABIOMED Inc page 30 11 07 OPERATING INSTRUCTIONS Normal 1 Turn power ON switch and line cord located at rear 2 Wait for display LEFT RIGHT SYSTEM READY FOR USE 3 Connect pneumatic line s from disposable at rear 4 To start pumping depress appropriate ON button 5 To stop pumping depress OFF button twice Weaning 1 Access WEANING CONTROLS Turn SELECT knob on
3. 115 hpa to 500 ft 1032 hpa CAUTION If the console has been stored in an environment exceeding the Operating Ranges let the console stabilize at the operating ambient prior to use to ensure specified 4 1 2 ABIOMED Inc 11 07 performance Electrical Mains voltage Mains frequency Mains current Average power consumption Line leakage current Power cable Battery Mechanical System Drive medium Drive technology Factory configured for operation from either 100 VAC 120 VAC 200 VAC 220 VAC or 240 VAC WARNING See section 8 8 for Fuse Rating Tables 47 to 63 Hz 4 3 A maximum 100 V 3 6 A maximum at 120 V 1 8 A maximum at 240 V 280 W Less than 100 UA at any input voltage 11 ft 3 4 m of 16 AWG Type SJT hospital grade plug N A 3 1m harmonized 3 x 1 00 mm 10 A 250 V European Internal 24 V battery provides 1 hour operating time when fully charged Charging time is 16 hours to full charge after 1 hour of use Compressed air Compressor system drives independent pressure regulated systems Switching from a pressurized page 9 4 1 4 ABIOMED Inc 11 07 Operator Controls Pump controls Weaning controls Alarm mute Operator display Outputs and Inputs LEFT and RIGHT device output SERVICE ONLY MONITOR input Pumping System Control General Flow rate Displayed Flow Accuracy Pumping rate Weaning method Weaning range t
4. 26 BVS Console Display Messages 2444444Hnnennnnnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnnnnnennnennnnnnnennnnnnnnnnnnnnnen 29 Operating Instruction Placard esii idii iinet e ee E Tie iieii iiei ees 31 SymbolS 2 en ni E E dines 34 ABIOMED Inc page 3 11 07 This page left blank intentionally ABIOMED Inc page 4 11 07 SECTION 1 INTRODUCTION 1 1 1 2 1 3 1 4 System Overview The ABIOMED BVS 5000 Bi Ventricular Support System is an automated bi ventricular support device intended to provide complete short term support of the left and or right sides of the heart The system uses a microprocessor based drive console to supply pneumatic power to a disposable blood pump Beat rates and systolic diastolic intervals are determined automatically by sensing drive line air flow at the console The console drives and adjusts the left and right blood pumps independently of each other BVS Blood Pump Refer to Instructions For Use The disposable BVS blood pump Figure 1 1 is a pneumatically driven two chambered device which supports one side of the heart The pump is placed external to the patient Blood inflow from the left atrium is returned to the thoracic aorta Inflow from the right atrium returns to the pulmonary artery Connection of the blood pump to the patient uses transthoracic cannulation techniques Figure 1 1 BVS blood pump BVS Cannula Refer to Instructions For Use There ar
5. Action Leave console plugged in until battery is charged BATTERY ON Line Cord disconnected and console running on battery Expect less than one hour operation on battery power BATTERY ON LOW Less than 10 minutes of Plug in console or obtain a battery operation remain backup Normal condition when console is turned off and plugged into AC power source CHARGING None required Table 6 2 Battery status message 6 5 Emergency System If the microprocessor based pump control system fails a fixed rate control system takes over This system will continue pumping at approximately 60 BPM and will light the emergency system indicator Table 6 3 When the emergency system is on only the rate and battery indicators are valid The ON and OFF buttons function normally but their indicator lights should be ignored If the emergency system was engaged by the direction of the processor a continuously pulsing audible alarm will sound Note Depression of the pump ON switches during self test is intended to activate emergency system This is normal operation To reset system turn power off wait 10 seconds then power on Message Cause Action EMERGENCY Microprocessor Obtain backup system SYSTEM ON system failure as soon as possible Call Service personnel Table 6 3 Emergency system message ABIOMED Inc page 22 11 07 SECTION 7 COMPLETE CONSOLE FAILURE 7 1 Foot Pu
6. above have been checked and these alarms continue to occur with pump rates at 20 to 30 BPM in the normal Operation mode Alarm Mute Pressing the alarm mute switch silences the audible alarm for one minute but does not affect the visual display of the alarm conditions A yellow light indicates that the alarm mute is activated At the end of the minute the alarm will be enabled again without operator intervention The mute interval is resettable but not cumulative This means that the operator can press the mute one or more times during the one minute period and the mute time will always be reset to one minute from the last activation of the button it will not add one minute to the time remaining from the previous mute period Continuous depression of the alarm mute switch does not extend the mute duration ABIOMED Inc page 21 11 07 6 4 Battery Status As long as the console line cord is plugged into an AC power source the internal battery will be kept in a charged state A row of indicators below the control panel shows the status of the battery Table 6 2 No indicators are illuminated when the console is plugged in and turned on and the battery is over 80 charged The console will periodically issue a two beep audible indication while operating on battery If the battery system enters the LOW condition the indication becomes a louder four beeps Message BATTERY CHARGING Cause Battery less than 80 charged
7. during transport by providing adequate clearance Check the driveline s that connect the blood pump to the console Make sure there are no kinks Carry inch tubing for any needed repairs or driveline extension Driveline extension up to 6 feet for a total maximum of 12ft has been done with some decrease in flow However this may not be appropriate for patients already in low flow conditions After repairing or extending the driveline depress OFF twice wait 3 seconds and depress ON Use of bed mount rather than IV pole may make maneuvering the blood pumps easier Console considerations 1 Planning adequate space is crucial Console specifications include Weight 194 Ibs 88 2kg height 33 inches 84cm width 24 inches 61cm and depth 22 inches 56cm Load all ancillary equipment monitors ventilators etc into transport vehicle before bringing patient down from the hospital Intensive Care Unit or Operating Room Pull the footpump out of the console prior to loading console into transport vehicle so that it will be readily accessible if it is needed Load the console into the transport vehicle prior to loading the patient Try to situate the console in a position where the display is readily visible Load patient into the vehicle feet first Console has a minimum average power consumption of 280 watts Make sure that the vehicle is able to provide the necessary power Make sure battery is fu
8. on the rear panel ABIOMED Inc page 13 11 07 HHHH mm Foot pump DT controls 34 Locking caster Battery indicators Weaning d c The display should read LEFT RIGHT SYSTEM READY FOR USE after self test Figure 5 3 LEFT SYSTEM RIGHT SYSTEM READY FOR USE READY FOR USE Figure 5 3 Display system ready for use If the display reads SELF TEST FAILED Figure 5 4 or if any message other than the READY FOR USE message appears call qualified service personnel immediately SELF TEST FAILED DO NOT USE SYSTEM Contact qualified service personnel MO xxxx xxxx M1 0000000 M2 XXXX XXXX M3 xxxx xxxx M4 xxxx xxxx M5 XXXX XXXX Figure 5 4 Display self test failure Note MO xxxx xxxx may not be displayed and M5 xxxx xxxx may be replaced with RAM xxxx xx xx Check the condition of the batteries If the BATTERY CHARGING indicators are illuminated the batteries are not capable of providing a full hour s operation of the console Allow more charging time before portable use The console is now ready for operation CAUTION Do not lean on or place any objects on the control panel 5 3 BVS Blood Pump Preparation See BVS 5000 Bi Ventricular Support System Blood Pump Instructions for Use prior to operation 5 4 Recommended Cannulation Method See BVS 5000 Bi Ventricular Support System Atrial Arterial Cannulae Instructions for Use prior to operation 5 5 Interconnection Procedure See BVS 5000 Bi Ventricular
9. ABIOMED BVS 50001 BI VENTRICULAR SUPPORT SYSTEM Operator s Manual CAUTION Federal U S A law restricts this device to sale distribution and use by or on the order of a physician For use only by personnel trained in accordance with the ABIOMED Training Program Read all warnings precautions and instructions carefully prior to use Manufactured by ABIOMED Inc C 22 Cherry Hill Drive Danvers MA 01923 USA 0086 N America 1 800 422 8666 24 Hour Emergency Hotline or 978 777 5410 Outside N A 01 978 777 5410 European Representative ABIOMED Europe GmbH Neuenhofer Weg 3 52074 Aachen Germany 49 241 8860 0 voice 49 241 8860 111 fax EU 24 Hour Emergency Hotline 49 0 1805 2246633 europe abiomed com email BVS 5000 Console EN60601 1 Class 1 93 42 EEC Class IIb g 0005 9016L November 2007 ABIOMED Inc and our authorized reps and distributors are responsible for the effect of safety reliability and performance of the equipment only if All service repairs and periodic maintenance are carried out by ABIOMED Inc or its authorized representative or distributor The electrical environment and installation of the User s site complies with all VDE requirements if applicable The BVS 5000 is only used in accordance with the Instructions for Use Copyright 1987 1989 1992 1993 1997 1998 2001 2002 2006 ABIOMED Inc All rights reserved ABIOMED BVS and Angioflex are
10. BPM typical 54 66 BPM 30 systole open loop control See section 7 Specifications Two filling and pumping Two inflow and outflow ABIOMED trileaflet Angioflex Polyurethane Angioflex Polyurethane 100 cc 100 cc lt 660 cc Left side 320 mmHg Right side 200 mmHg gt 325 mmHg gt 410 mmHg lt 6 5 mmHg at 10L min Compressed air Class VI medical grade polycarbonate page 11 Patient connections Blood Pump inflow Blood Pump outflow Atrial cannula 10 7mm Cannula Supplied with Cannula restraint tunneling bullet and tie wraps Arterial cannula Supplied with Cannula restraint and tunneling bullet Drive line connection Sterilization Weight Mounting methods Blood Pump mounting height Storage conditions 48 inches 1 2m of 1 2 inch 12 7mm 1 D 3 32 inch 2 4mm wall thickness Class VI surgical grade PVC tubing with 1 2 inch 12 7mm to 1 2 inch 12 7mm Class VI polycarbonate tubing connector attached 72 inches 2m of 1 2 1 D 3 32 inch 2 4mm wall thickness Class VI surgical grade PVC tubing with 1 2 inch 12 7mm to 1 2 inch 12 7mm tubing connector attached 32 French reinforced malleable 42 French 14mm reinforced malleable 10mm Hemashield graft Arterial outflow cannula 12mm pre coated Dacron Arterial outflow cannula 72 inches 2m of PVC Class VI tubing 1 4 inch 6 4mm I D attached to the blood pump for console interface
11. Foot Pump a Guide the coiled hoses into the slot Squeeze the pump closed and slide it into the slot behind the hoses b Swing the transfer lever down 1 4 turn clockwise to engage the console pump Note The transfer lever must be turned back down or the console will not operate If the lever is not turned back down fully a message of FOOT PUMP HANDLE IS DISLODGED will appear on the display ABIOMED Inc page 23 11 07 This page left blank intentionally ABIOMED Inc page 24 11 07 SECTION 8 ROUTINE MAINTENANCE AND SHIPMENT 8 1 8 2 8 3 8 4 8 5 8 6 8 7 Routine Check of Backup Systems lt is recommended that the BVS console emergency systems be checked out regularly This should be done on the day previous to scheduled surgery and during preventive maintenance The procedure is to test the foot pump run the regular power up self test and activate the emergency control system Foot Pump Test With the unit off open the rear cover Remove and set up the foot pump refer to Section 7 Operate the pump and check that air flows out of both nozzles Replace the foot pump Make certain that the transfer lever is returned to the down position after testing is complete If it is not FOOT PUMP HANDLE IS DISLODGED will appear on the display Self Test Routine Remove the line cord and plug into an outlet Open the weaning door Turn on the power switch Check the flashing panel indicators Assure that all indica
12. It should be connected to appropriate left right hose barb on the console The disposables are ethylene oxide gas sterilized the blood pump is packaged in a Tyvek PETG tray and the cannulae in a Tyvek Mylar pouch 3 5 Ibs 1 6 kg BVS blood pump can be mounted to an I V pole or vertical pole mount or to the bed with the appropriate selection of accessories 42 Fr 14mm 0 10 inches 0 25cm below the level of the patient s atrium 32 Fr 10 7mm 4 14 inches 10 35cm below the level of the patient s atrium 10 C to 40 C relative humidity 30 to 75 The 10mm Hemashield graft arterial cannula is Gamma sterilized ABIOMED Inc 11 07 page 12 SECTION 5 INSTALLATION 8 OPERATION 5 1 Installation Prior to clinical use on site installation and testing of this Console shall be performed by an Authorized ABIOMED Service Representative 5 2 Console Power Up and Self Test DANGER Explosion risk if used with Flammable Anesthetics CAUTION If the console has been stored in an environment exceeding the Operating Ranges let the console stabilize at the operating ambient prior to use to ensure specified performance If possible the BVS console should be powered up one hour before use however there is no minimum warm up time required A self test procedure automatically runs after power up and requires about one minute to complete During self test the console flashes all indicators sounds the alar
13. MPING RIGHT SYSTEM PRESS OFF AGAIN READY FOR USE Figure 5 6 Display after pressing OFF button once page 15 5 7 Battery Operation and Transport When the patient is transported from the operating room to intensive care the blood pump can be mounted to the bed The console is unplugged and rolled along with the patient The internal battery when fully charged will automatically power the console for one hour The battery requires approximately 16 hours to charge after one hour of use 5 7 1 ABIOMED Inc 11 07 Mounting the Blood Pump to the Accessory Bracket Two types of accessory brackets are available to mount the blood pump for transport Figure 5 7 Each bracket can hold one or two blood pumps The BVS I V pole mount attaches to a standard I V pole The BVS bed mount slips under the patient s mattress 5 7 1 1 To attach the BVS Pole Mount to the I V Pole 5 7 1 2 Unscrew the screw clamp enough to fit the clamp around the I V pole Tighten the screw clamp onto the I V pole by turning the black knob clockwise Adjust the height of the Pole Mount by turning the central adjustment lever counter clockwise one half turn to loosen it while holding the handle instead of pointing down the adjustment lever will now be pointing up towards 12 o clock Move the Pole Mount up or down with the handle to the desired position Turn the central adjustment lever clockwise back to its original position to secure
14. Support System Blood Pump Instructions for Use prior to operation 5 6 Pumping Connect the pneumatic line s from the disposable to the drive ports on the rear of the console To start pumping depress the appropriate ON button If bi ventricular support is required start pumping on the left side before starting pumping on the right If pumping is started prior to connecting the disposable the system will require additional time before reaching full flow Full flow can be achieved faster in this situation by stopping pumping and then immediately restarting pumping 5 6 1 Expected Beat and Flow Rates ABIOMED Inc page 14 11 07 5 6 2 5 6 3 ABIOMED Inc 11 07 Observe the beat rate Figure 5 5 Any gross instability of beat rate double beats etc indicates a possible problem with the placement of the blood pump relative to the patient refer to Section 5 6 2 LEFT RATE xxx BPM RIGHT SYSTEM OUTFLOW xx x L M READY FOR USE Figure 5 5 Display normal pumping A step change in rate is normal especially during the first two minutes During this period the console adjusts itself to determine the optimal pumping rate A brief extension of one beat every two minutes is normal as the console periodically recalibrates itself Adjustment of Blood Pump Filling Proper filling of the blood pump can easily be assessed through an examination of blood pump flow and the behavior of the upper bladder When operating in the normal full fl
15. ancy Should the microprocessor based system fail a hardware based backup system continues pumping at a fixed rate In case of complete console failure a foot operated pump allows continued support Figure 1 2 BVS System 5000 console 1 5 Accessories Pole Mount Refer to Instructions For Use The BVS I V pole mount is provided as a mounting bracket for the BVS blood pump while in use It attaches to an I V pole and can accommodate two blood pumps Bed Mount Refer to Instructions For Use The BVS bed mount is also an accessory that can be used to secure the blood pump during patient transport It slides between the mattress and bed and can accommodate two pumps This obviates the need for transporting the pumps on an I V pole next to the patient Pump Mount Set Includes pole and bed mounts as described above SECTION 2 0 INDICATIONS FOR USE The BVS 5000 Bi Ventricular Support System is a mechanical circulatory support system for use in patients suffering from reversible ventricular dysfunction These are patients who have undergone successful cardiac surgery and subsequently develop low cardiac output or patients who suffer from acute cardiac disorders leading to hemodynamic instability The intent of BVS device therapy is to provide circulatory support restore normal hemodynamics reduce ventricular work and allow the heart time to recover adequate mechanical function The BVS console device is external to the patient
16. and is intended for short term use ABIOMED Inc page 6 11 07 Appropriate patient groups incude 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 following heart surgery Failed transplant patients who require ventricular assist following heart transplantation e Patients who require right heart assist RVAD support while on implantable left ventricular assist devices LVAD s Patients suffering from acute cardiac disorders such as viral myocarditis A patient is a candidate for mechanical assistance with the BVS device if she he meets all of the following criteria Patient has a body surface area gt 1 3 m and is lt 75 years of age Patient is in relatively good health other than the cardiovascular problem for which surgery was undertaken All appropriate measures have been attempted to correct low arterial pH arterial blood gas abnormalities electrolytes hypovolemia hypervolemia inadequate cardiac rate dysrhythmias and residual hypothermia Cardiac resuscitation employing pharmacologic agents in a systematic fashion has been attempted While the use of the Intra Aortic Balloon Pump IABP is recommended prior to BVS assistance its use may not always be appropriate e g fibrillating heart peripheral atherosclerosis Patient is unable to be
17. ange and or when the console periodically adjusts blood pump ejection duration to optimize flow However actual blood pump flow will correspond to the selected flow setting ABIOMED Inc page 19 11 07 This page left blank intentionally ABIOMED Inc page 20 11 07 SECTION 6 ALARMS AND STATUS INDICATORS 6 1 6 2 6 3 Introduction The BVS console provides alarms for high or low pumping pressure and low blood flow These alarm messages appear on the display screen and on the panel above the display Status indicators of the emergency pumping system and battery system appear below the pump controls Flow and Pressure Alarms The low flow and high or low pressure alarms Table 6 1 are derived from the pressure of the drive line to the blood pump The drive line pressure and flow are measured inside the BVS console Blood flow is calculated based upon these measurements Flow and pressure alarms will typically indicate a blocked drive line or blood line They may also indicate blood pump placement at the wrong height relative to the patient Alarm Message Probable Causes e Obstruction of blood lines LOW FLOW e Blood pump place too high relative to atrium e Inadequate blood volume HIGH PRESSURE e Drive line or blood pump lines kinked or LOW FLOW occluded LOW PRESSURE e Disconnection or leak in drive line LOW FLOW Table 6 1 Flow and pressure alarm CAUTION Obtain a backup console if all of the
18. ation syringe and sterile sponges Nylon straps to secure console ABIOMED Inc page 36 11 07
19. e two cannulae supplied with each blood pump one for left and right atrial connections and one for the aortic or PA connection The atrial and arterial cannulae are both supplied with tie wraps a tunneling bullet for tunneling the cannula through the skin and a cannula restraint for the cannula connector junction The arterial cannula is manufactured with a coated woven graft bonded to one end This graft permits end to side anastomosis of the cannula to the PA or aorta The elastomeric coating on the graft eliminates the need for preclotting and provides a graft porosity lt 1cc min cm BVS Console The BVS console Figure 1 2 is a microprocessor controlled pneumatic drive system which can operate one or two disposable blood pumps The console automatically adjusts the beat rate and systolic diastolic ratio based on air flow into and out of the blood pump Blood pump flow and rate are displayed on the control panel The console incorporates several systems to ensure safe operation Automatic self testing upon power up alerts the operator about potential problems while the operator observes the control panel during the test procedure Battery backup is provided for one hour when fully charged of portable or power fail operation An alphanumeric display and message indicators show BVS system status Alarms alert the operator to abnormal flow or pressure conditions ABIOMED Inc page 5 11 07 The console has two levels of operational redund
20. ed as a reminder If flows drop below 0 5 L min a continuous audible alarm will be activated ABIOMED Inc 11 07 page 18 5 8 1 Weaning Adjustment WEANING o ACTIWATE ACTIVATE Figure 5 10 To begin weaning open the weaning door Turn the appropriate SELECT knob clockwise figure 5 10 The WEANING indicator will light The ACTIVATE light will begin to blink and the ACTIVATE message will appear on the display Figure 5 11 To set flow press RIGHT SYSTEM and hold ACTIVATE READY FOR USE Figure 5 11 Display weaning activation Press the ACTIVATE button and turn the SELECT knob to set the desired blood flow Figure 5 12 The setting of the SELECT knob will appear on the display as long as the ACTIVATE button is being pressed Turn SELECT to set RIGHT SYSTEM FLOW xx x L M READY FOR USE Figure 5 12 Display weaning adjustment When the ACTIVATE button is released the console will begin to adjust itself toward the new weaning flow Figure 5 13 This will generally take at least 8 beats LEFT RATE xxx BPM RIGHT SYSTEM WEANING 9 xx x L M READY FOR USE Figure 5 13 Display weaning operation To return to normal operation turn the SELECT knob counterclockwise to the OFF position The console will automatically return to full available flow During the Weaning operation the console s displayed flow may vary for several beats from the selected flow setting This has occurred when patient conditions ch
21. facture SN Serial Number REF Part Number LOT Lot Number A Alarm Inhibit Caution Proximity to sources of electromagnetic fields such as cellular phones may affect the performance of the console ABIOMED Inc page 34 11 07 PATIENT TRANSPORT WITH THE BVS 5000 BI VENTRICULAR SUPPORT SYSTEM In some instances a patient on BVS 5000 support may need to be transported to another medical center Examples of potential reasons for transport include moving patients to centers with greater cardiac support experience and resources If a patient needs to be transported to another medical center the following information should be considered Planning ahead and being prepared is important and makes any transport easier Although ABIOMED has received information from many hospitals indicating that they have successfully used the BVS 5000 system for patient transport ABIOMED has not directly tested the BVS 5000 for patient transport Accordingly ABIOMED cannot endorse or recommend the BVS 5000 for patient transport The information below is based upon the reported experience of hospitals that have used the BVS 5000 system for transport Blood Pump considerations 1 The Blood Pump is 18 inches long The top of the blood pump should be level with or below the patient s atrium to give good flows Remember that pump filling is accomplished by gravity and the patient s preload Ensure that the Blood Pump is not damaged
22. fy 0005 0010 G1 German 120VAC 0005 0010 G2 German 220 or 240VAC specify Catalog Number Description Contents 0005 0090 BVS I V Pole Mount 1 per box 0005 0080 BVS Bed Plate Mount 1 per box 0005 0060 BVS Pump Mounting Set 1 per box 0005 9017 BVS 5000 Console 1 per box BVS Disposables Catalog Number Blood Pump Sets 0505 0032 0505 0042 0505 0032 H 0505 0042 H ABIOMED Inc 11 07 Service Manual English only Description Each blood pump set includes 1 blood pump 1 atrial cannula 1 arterial cannula and 3 tubing covers BVS Blood Pump Set 32 Fr 10 7mm Atrial 12mm graft Arterial Cannula BVS Blood Pump Set 42 Fr 14mm Atrial 12mm graft Arterial Cannula BVS Blood Pump Set 32 Fr 10 7mm Atrial 10mm graft Arterial Cannula BVS Blood Pump Set 42 Fr 14mm Atrial 10mm graft Arterial Cannula page 27 0505 0032 MH 0505 0042 MH Cannulae 0506 0032 1AT 0506 0032M VA 0506 0042 AT 0506 0042M VA 0506 0042 AR 0506 0010 HAR ABIOMED Inc 11 07 BVS Blood Pump Set 32 Fr M VA 10 7mm Atrial 10mm graft Arterial Cannula BVS Blood Pump Set 42 Fr M VA 14mm Atrial 10mm graft Arterial Cannula 32 Fr 10 7mm Atrial Inflow Cannula 32 Fr 10 7mm Atrial Inflow Cannula 42 Fr 14mm Atrial Inflow Cannula 42 Fr 14mm Atrial Inflow Cannula 12mm graft Arterial Outflow Cannula 10mm Hemashield graft Arterial Outflow Cannula page 28 BVS CONSOLE DISPLAY MESSAGES
23. iod of one 1 year from the date of installation Extended warranty and service may at ABIOMED s option be offered for an additional charge in which event separate or additional terms and conditions may apply The express warranty set forth on this page is the only warranty given by ABIOMED with respect to any goods furnished hereunder ABIOMED makes no other warranty express implied or arising by custom or trade usage and specifically makes no warranty of merchantability or of fitness for any particular purpose Said express warranty shall not be enlarged or otherwise affected by ABIOMED s rendering of technical or other advice or service in connection with the Goods ABIOMED shall not be liable for incidental or consequential losses damages or expenses directly or indirectly arising from the sale handling or use of the Goods or from any other cause relating thereto and ABIOMED s sole responsibility under this warranty will be at its option to 1 repair or replace the Goods or any components of the Goods found to be defective in workmanship or material during the foregoing warranty period or 2 to refund the purchase price paid All replaced components and Goods will become the property of ABIOMED This warranty shall not apply if the Goods have been a repaired or altered in any way by other than ABIOMED or ABIOMED authorized service personnel b subjected to physical or electrical abuse or misuse or c operated in a manner incons
24. istent with ABIOMED s instructions for use of the Goods If ABIOMED determines that a claim was not caused by ABIOMED or ABIOMED s authorized service personnel then Buyer shall pay ABIOMED for all related costs incurred by ABIOMED This warranty is not transferrable without the express written consent of ABIOMED Under this warranty ABIOMED will provide at no charge updates or modifications which directly affect the safe operation of the Goods ABIOMED is not obligated to provide updates or modifications which provide a product improvement or enhancement b new product features or c options to the Goods ABIOMED has no obligation to provide a loaner system during service or maintenance of the Goods however at ABIOMED s sole discretion ABIOMED may provide such loaner systems This warranty applies to the BVS 5000 console only and not to any disposable or other component of the BVS 5000 system Specific items excluded from this warranty include but are not limited to blood pumps cannula and external tubing This warranty may not be amended without the express written consent of an authorized officer of ABIOMED Inc U S Patents 4 782 817 and 4 826 477 Symbol Definitions ABIOMED Inc page 33 11 07 9 EN60601 1 Type CF equipment Attention consult instructions Danger Risk of Explosion if used in the presence of flammable anesthetics Dangerous Voltage Rechargeable battery E a II VAAN Year of manu
25. ith pump height as specified in Section 5 6 Left side gt 4 8 L min at outflow pressures of 90 mmHg and inflow pressure of gt 10 mmHg Right side gt 4 0 L min at outflow pressure of 40 mmHg and inflow pressure of gt 10 mmHg Rate reduction via computer control 0 5 L min to full available flow page 10 4 1 7 Alarm Limits LOW FLOW LOW PRESSURE HIGH PRESSURE BATTERY ON LOW BATTERY CHARGING Hardware Backup System Indication Allowable low limit Allowable high limit Backup pumping rate Foot Pump 4 2 BVS Blood Pump Specifications ABIOMED Inc 11 07 Parameter No of bladders No type of valves Bladder valve material Volume of pumping bladder Volume of filling bladder Extracorporeal volume system Operating pressures on bladder Bladder burst pressure Valve prolapse pressure Valve forward flow A P Drive medium applied to bladder Housing material lt 1 8 L min flow lt 0 5 L min flow in weaning Left side lt 80 mmHg during systole Right side lt 50 mmHg during systole Left side gt 309 mmHg during systole Right and left side gt 50 mmHg during diastole Right side gt 190 mmHg during systole Less than 10 minutes of battery time remaining This is the minimum time remaining when LOW first comes on Displayed when battery is below 80 capacity EMERGENCY SYSTEM ON indicator Backup engages if system pumping lt 3 BPM Backup engages if system pumping gt 140
26. lly charged prior to transport ABIOMED Inc page 35 11 07 7 10 11 Satisfactory operation should be expected from a nominal 120 Vac 60 Hz sine wave source with at least 500 watt capacity or from a 120 Vac 60 Hz quasi sine wave source i e Vanner Model 20 1000TUL A square wave source should not be used Because of the varying waveshape battery charging should not be expected and the Battery Charging indicator will usually not indicate a low battery condition Remember that the footpump is available for use if needed The transport vehicle s inverter should be operating before the BVS line cord is connected All power in the transport vehicle including lights should be ON before plugging in console Unplug console s power cord prior to transport vehicle shutdown Monitor battery life Console has a maximum battery life of one hour when fully charged Much if not all of this can be consumed during the transfer back and forth from the ambulance to the ICU Remember that the footpump is available for use if needed Fasten the console to the ambulance aircraft with appropriate straps ex 1 inch nylon to prevent movement Examples of Additional Equipment to Consider 1 2 3 4 5 6 Power strips for extra outlets for use with equipment other than the BVS 5000 system Monitors EKG BP and PA CVP Extra oxygen tanks Bed mount for BVS 5000 Blood Pump Sterile gloves tubing clamps irrigation bowl irrig
27. m tone and pumps air through the drive ports It also checks the processor system integrity The operator should observe the control panel during the self test to detect any abnormalities Do not depress pump ON controls during self test This will result in activation of emergency system See Section 6 5 Power IE Transfer lever Line Cord drive ports Pressure flow Pump controls alarms Maintenance jack a e e Display screen Emergency system ill rer Figure 5 2 BVS control panel with Cover indicators illuminated Figure 5 1 BVS console rear panel a Open the rear cover Figure 5 1 remove the line cord and plug into an outlet Check that the CHARGING indicator is lighted on the front panel Close the cover while routing the cord out through the side opening provided Open the weaning door Activate the console with the power switch on the rear panel The system will automatically begin to run its self test CAUTION Unplug line cord to disconnect all AC power from console Check visible and audible machine functions watch for the flashing of all alarm and status lamps Figure 5 2 Only the EMERGENCY SYSTEM ON and BATTERY indicators will not light Some BATTERY indicators may be lighted depending on battery condition Listen for the alarm tone It first sounds loud and fast then sounds softer and slower Listen for valve actuation and the sound of air venting from the drive ports located
28. mp In the case of complete console failure the foot operated pump allows manual operation of the blood pump The foot pump is stored inside the rear cover It can be removed for use after operating the transfer valve lever in front of it A complete console failure is indicated by no air being pumped regardless of how the controls are operated 7 2 Removing and Operating the Foot Pump a Turn off the console Open the rear cover b Move the transfer lever up 1 4 turn counterclockwise to the horizontal position Grasp the foot pump by hand squeeze the pedal closed and pull it out of the slot as shown in Figure 7 1 transfer lever up foot pump N WI AND A Figure 7 1 Removing foot pump Figure 7 2 Operating the foot pump c Place the pump on a level floor Make sure the hoses are not kinked d Completely depress the pump with your foot Figure 7 2 Allow it to fully return to its original position Repeat This should result in a normal pumping rate of 30 to 40 times per minute Observe the blood pump for proper filling and emptying If the console is restarted use of the foot pump must be stopped during the first four seconds of the self test e Obtain a backup BVS console Power it up and allow the self test to run Begin pumping by pressing the ON button Transfer the drive line from the failed console to the backup f Call service personnel at the earliest opportunity to repair the failed console 7 3 Stowing
29. n replace fuses per the Fuse Rating Tables below ONLY WITH 3AG type Glass Body Time Delay fuses Littelfuse series 313XXX Slo Blo or equivalent with the following ratings Fuse Rating Tables For All MAINS Input Settings No Rating Agency Approvals Littelfuse REF F2 12A 32V None 313012 F3 4A 250V UL CSA 313004 F4 3A 250V UL CSA 313003 F5 5A 250V UL CSA 313005 F6 5A 250V UL CSA 313005 F9 4A 250V UL CSA 313004 F10 4A 250V UL CSA 313004 For MAINS Input 120VAC No Rating Agency Approvals Littelfuse REF F7 5A 250V UL CSA 313005 F8 5A 250V UL CSA 313005 For MAINS Inputs 200 220 240VAC No Rating Agency Approvals Littelfuse REF F7 3A 250V UL CSA 313003 F8 3A 250V UL CSA 313003 For MAINS Input 100VAC No Rating Agency Approvals Littelfuse REF F7 6 25A 250V UL CSA 3136 25 F8 6 25A 250V UL CSA 3136 25 8 9 Service For service contact ABIOMED Inc page 26 11 07 North America ABIOMED Inc 22 Cherry Hill Drive Outside North America Authorized ABIOMED Distributor Danvers Massachusetts 01923 978 777 5410 800 422 8666 8 10 Ordering Information BVS Equipment Catalog No Language Mains voltage 0005 0010 E1 English 120VAC 0005 0010 E2 English 220 or 240VAC specify 0005 0010 E3 English 100VAC 0005 0010 F1 French 120VAC 0005 0010 F2 French 220 or 240VAC speci
30. nnen dS 16 5 8 Weaning merani nan evi Mab nant a e a a e a hei eek 18 Section 6 Alarms and Status Indicators 6 1 Arodu CiO amas ss a 21 6 2 Flow and Pressure Alarms 0442444000nnnnnnnnnannannnnnnannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 21 6 3 gt Alan Mute deine tee eis oe ete ee ee i A ee ees 21 6 4 Battery talla scientist A dst ei om TA 22 6 5 Emergency SyStemmiisseiscievccias costo cents see recess O 22 Section 7 Complete Console Failure FAVE POOUP UM Pies 22 ee ee ceed coulitaceuaed cudeubidiessetehadtnece hal ceeeds 23 7 2 Removing and Operating the Foot PUMP eee ceeseeeeeceeenneeeeeeeeeeeeeeeeeaeeesesaeesaeeeeeaaeeseeeeeesieeeeneeeeenaees 23 1 3 _ StoWwing FOOE PUMPE aii 23 Section 8 Routine Maintenance and Shipment 8 1 Routine Check of Backup Systems uuerssunennnnensnnnnennnnnnnnnnnennnnnn nennen nennen nnnn ernennen nenn nennen nennen nnnrnnn 25 8 2 Foot Pump Test aia bas 25 8 3 Sef eS ROUTING PRBEAIERESTRERRIEFEERRRERSPHRETEEERTERRURSERSFERTIFEFEEFERFIESTEERPEERERLREFFLESSERRCHEIFEHKLERTEISFERERTEFESTELERGERFIFFLEFPERFIRER 25 8 4 Emergency System TeSt nri nie aa anne E A E E AA ta Ea 25 8 5 Packagingifor Shipment vcd a a Ea ioeie 25 AA E minei nee O E iE 25 8 7 Scheduled Mainten nce u422 2 een en re sea 26 8 8 BVS Replacement Part iia 26 8 9 ni 01 PRERERSERIEHERIS a eee e a E ra iae o a a E A a A a a aa aai 26 8 10 Ordering O
31. o a non pressurized state in the blood pump is via independent 3 way solenoid valves Return air is allowed to vent to atmosphere no vacuum is used Left line pressure regulated to 320 mmHg Right line pressure regulated to 200 mmHg Pressing Left or Right ON button initiates pumping Pressing Left or Right OFF button twice within 13 seconds typical ceases pumping While pumping the SELECT potentiometer is turned while depressing the ACTIVATE button The desired flow is selected and the ACTIVATE button is released to engage weaning at the selected flow rate Silences audible alarm for one minute except for complete console failure which has separate alarm 4 line by 40 character LCD with electro luminescent backlighting Blood pump interface 1 4 in 6mm I D hose barb DB15 connector for ABIOMED keyboard monitor assembly Used for troubleshooting by ABIOMED authorized service personnel only Filling and emptying of disposable is controlled by computer examination of air flow and volume into and out of the blood pump Calculated by the computer system integrating the area under the air flow curve and performing a four beat weighted average of the results With pump height as specified in Section 5 6 Left side 15 over the following ranges Inflow Pressure 5 to 25mmHg Outflow Pressure 60 to 90mmHg Right side 15 over the following ranges Inflow Pressure 5 to 15mmHg Outflow Pressure 30 to 40mmHg W
32. oduced to advise the operator of low battery status The operator should either plug in the console line cord or obtain a backup console CHARGING without the word BATTERY appears when the console is plugged in but turned off This indicator is not related to the charge state of the battery it simply indicates the availability of power to charge the battery if needed or to maintain a fully charged condition Preparing the Console for Transport Battery operation is automatically activated by unplugging the line cord When ready for transport open the rear cover unplug the line cord and wind it around the cord carrier Close the cover Roll the console carefully to avoid kinking or disconnection of the drive line To carry the console over obstacles grasp the recessed handholds under the sides of the top panel Make certain to lift the console by the top of the side panels and not by the top panel Be careful that your hand does not get pinched between the top and side panels CAUTION Do not attempt to lift the console by the top panel Equipment damage may result 5 8 Weaning When the patient is to be weaned from the BVS system the blood pump output may be set at any desired flow from 0 5 L min to full flow in 0 1 L min increments The operator simply selects the desired flow rate and the console reduces its pumping rate to achieve the desired flow Whenever the weaning controls are activated a periodic audible beep will be issu
33. ow mode flow should be greater than 2 L min and typically ranges from 3 L min to 6 L min To optimize blood flow first make certain that the patient is appropriately hydrated with filling pressures within their normal ranges If the patient is hypovolemic administer fluids according to standard procedures Second observe the filling and emptying of the upper bladder The bladder should just barely fill the plastic chamber during pump systole and just empty during pump diastole If the bladder is too full move the blood pump higher to reduce inflow pressure If the bladder is too empty and the patient is sufficiently hydrated lower the pump to increase inflow pressure The top of the upper bladder chamber should be positioned between 0 and 14 inches 35 cm below the patient s atria If the pump is raised above the level of the patient s atria or is lowered more than 14 inches 35cm below the patient s atria a decrease in pump flow may result After adjusting blood pump height observe bladder filling for two minutes before adjusting again This will allow the system to reach steady state before further adjustment To Stop Pumping To stop pumping press the appropriate OFF button twice within thirteen seconds typical The button must be pressed twice to stop the pump Figure 5 6 This is a safety feature to prevent accidental operation A single press of the OFF button will be ignored after thirteen seconds typical TO STOP PU
34. rgent with a wet sponge is suggested for the console enclosure if necessary Note Do not allow the following agents to come in contact with the BVS blood pump because they may attack the plastic and cause damage to the device halogenated hydrocarbon based anesthetic agents other halogenated hydrocarbons such as chloroform highly alkaline chemicals such as sodium hydroxide aromatic hydrocarbons such as line and ketones such as acetone Scheduled Maintenance ABIOMED Inc page 25 11 07 8 8 The BVS console should be installed and maintained by ABIOMED Inc an authorized service agent or distributor only The periodic maintenance schedule calls for Maintenance Period Perform cleaning functional test and calibration 1 year Replace batteries 2 years 2500 hours of use 7000 hours of use 5000 hours of use Estimated useful console life 8500 hours of use Replace solenoid valves Replace compressor Replace pressure regulators and filters Please contact the authorized distributor if the hospital record does not show that this schedule has been maintained Warning Sealed lead battery must be recycled or disposed of properly is At end of console life remove the battery and recycle or dispose of properly Dispose of the remaining console per applicable local regulations BVS Replacement Parts Contact your authorized ABIOMED representative for spare parts list WARNING For continued overload protectio
35. s from the top down 5 Make sure that both edges of the blood pump bracket fully engage the blood pump backplate to ensure that it is attached securely 5 7 1 4 Attaching the BVS Blood Pumps to the console 1 Connect the drive line from the blood pump to the respective right or left hose connector on the back of the console Figure 5 7 BVS LV pole mount BVS LV driveport pole mount driveline outflow tube Figure 5 7 Blood Pump accessory Mounting brackets Figure 5 8 Blood pump hooked up to console 5 7 2 Battery Status As long as the console line cord is plugged into an AC power source the internal battery will be kept in a charged state A row of indicators below the control panel Figure 5 9 shows the status of the battery ABIOMED Inc page 17 11 07 5 7 3 No indicators are illuminated when the console is plugged in and turned on and the battery is over 80 charged BATTERY ON CHARGING LOW Figure 5 9 Battery status indicators BATTERY CHARGING appears when the console is plugged in and turned on and the battery charge is less than 80 capacity BATTERY ON appears when the line cord is disconnected and the console is operating on its battery A periodic two beep audible signal also indicates that the battery is on BATTERY ON LOW appears when the line cord is disconnected and less than 10 minutes minimum of battery operation remains A loud periodic three or four beep audible signal is pr
36. the Pole Mount in place To attach the BVS Pole Mount to the Bed Mount 9 Hold the bed plate so the metal post faces up Slide the bed plate under the head of the mattress between mattress and bed so that the metal post is facing up next to the mattress The weight of the mattress and the patient will hold the Bed Mount Plate in place Hold the Pole Mount by the handle Unscrew the screw clamp enough to fit the clamp around the metal post Tighten the screw clamp onto the metal post by turning the black knob clockwise Adjust the height of the Pole Mount by turning the central adjustment lever counter clockwise one half turn to loosen it while holding the handle Instead of pointing down the central adjustment lever will now be pointing towards the 12 o clock Move the Pole Mount up or down with the handle to the desired position 10 Turn the central adjustment lever clockwise back to its original position to secure the Pole Mount in place page 16 5 7 1 3 To attach the BVS Blood Pumps to the Pole Mount 1 Along plastic plate is attached to the back of the blood pump 2 At the top of this plate slightly above the upper inflow bladder is a square backplate designed to slide into the blood pump bracket 3 Hold the blood pump securely so the inflow and outflow tubing is at the top of the blood pump and the drive line is at the bottom of the blood pump 4 Slide the backplate into one of the blood pump bracket
37. tor lights work and that the alarm tone sounds Listen for valve actuation and for the sound of air venting from the rear panel pump connections The display should read LEFT RIGHT SYSTEM READY FOR USE If any display other than this appears such as SELF TEST FAILED consider the unit inoperable Obtain a backup unit and call qualified service personnel immediately Refer to Section 5 2 for more details Emergency System Test Shut off the power switch in back of the unit Then turn on power During the self test period while the indicator lights are flashing press one of the ON buttons for approximately 2 seconds Wait for approximately 90 seconds from the end of self test for the emergency system to activate The EMERGENCY SYSTEM ON message and the RATE lamp should blink as the console pumps Turn off the console power switch to deactivate the emergency system Packing for Shipment If it becomes necessary to ship the BVS console a long distance by vehicle it should be shipped only in its original shipping crate If the original crate is not available contact ABIOMED for a substitute crate and packing instructions Cleaning The BVS blood pump can only be cleaned by the use of soap and water on all accessible parts The console display control panel area should be cleaned with isopropyl alcohol and cotton It is recommended that the display window only be cleaned this way or with soap and water to avoid scratching Use of a mild dete
38. trademarks of ABIOMED INC and are registered in the U S A and certain foreign countries AB5000 is a trademark of ABIOMED INC ABIOMED Inc page 2 11 07 TABLE OF CONTENTS Section 1 Introduction 1 1 SYSTEMMOVEMIOW sita sia 5 1 2 BVS Blood PUN Piscina le da clio 5 1 3 BVS Gannula a dues E deeavedetecuoi ees 5 1 4 BVYS Gons ler ria AA tem cod ads a 5 1 5 ACCESSORIES 7 E A EEEE E TE EE Neger neue A PA EEE EEA E E A 6 SECTION 2 Indications For USE A Se En 6 Section 3 Contraindications For US ooononcocococococcccccconococononononincncnananananon nono non nn ono no nonononononn EEEE EEEE EEEE Ennn nnt 7 Section 4 Specifications 4 1 Console aes rec sete es o en hs sy ind a SS e edo e oe 9 4 2 BVS Blood Pump Specifications cccccccceeececseececeeeceeeeaeceeeeeeeeeeaaeaeceeeeeseeaeaeeeeeseseccaeaeeeeeeseesaeaeeeeeees 11 Section 5 Installation and Operation 5 1 Installation 242222 na rs re N Gag dd aad Ee 13 5 2 Console Power Up and Self Test 244urnnnnnennnnenennnnnnnnnnnnnnnnnnnnnnennnnnennnnnnnnnnnennnnnnennnnnen nenn nn nennen 13 5 3 BVS Bloo0d Pump Preparati n nennen cias 14 5 4 Recommended Cannulation Method u42444400snnnnnnnnnennnnnnnnennnnnnnnnannnnnnnnnnnnnannnennnnnn nenn 14 5 5 Interconnection Procedure cocos A aid 14 9 65 PUMDINO rascar ta 14 5 7 Battery Operation and Transports sssrinin arapi nennen nennen e EENE EA a ne
39. weaned from cardiopulmonary bypass or is unable to maintain acceptable hemodynamics in the immediate postoperative period lt 6 hours after the first attempt to wean from CPBP or Patient is unable to maintain acceptable hemodynamics following a significant cardiac event despite the measures cited above SECTION 3 0 CONTRAINDICATIONS FOR USE 1 Major cardiac or extracardiac catastrophes occurring during operation or in the postoperative period which preclude survival such as uncontrolled hemorrhage massive air embolization interstitial pulmonary hemorrhage with inability to maintain adequate ventilation pump oxygenator or perfusion difficulties or massive transfusion reaction hemolysis during bypass or inadequate BVS cannulation 2 Central nervous system damage resulting in fixed and dilated pupils ABIOMED Inc 11 07 page 7 This page left blank intentionally ABIOMED Inc page 8 11 07 SECTION 4 0 SPECIFICATIONS 4 1 Console 4 1 1 Physical Width Depth Height Weight Operating Temperature Range Operating Humidity Range 24 inches 61 cm 22 inches 56 cm 33 1 4 inches 84 5 cm 194 Ibs 88 2 kg 10 C to 40 C 30 to 75 non condensing Operating Atmospheric Pressure Range 6 000 ft 812 hpa to 500 ft 1032 hpa Storage and Transport Temperature Range 20 C to 70 C Storage and Transport Humidity Range 0 to 85 non condensing Storage and Transport Pressure Range 50 000 ft
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