BVS 5000t Operator`s Manual
Contents
1. Arterial cannula Supplied with Cannula restraint and tunneling bullet Drive line connection Sterilization Weight Mounting methods Blood Pump mounting height Storage conditions 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 e 42 French 14mm reinforced e 36 French 12mm reinforced malleable backbone e 32 French 10 7mm Cannula e 12 mm reinforced with precoated outflow graft e 10 mm non wire reinforced with pre coated Hemashield gratt 72 inches 2m of PVC Class VI tubing 1 4 inch 6 4mm I D attached to the blood pump for console interface It should be connected to appropriate left right hose barb on the console The disposables are ethylene oxide gas sterilized or gamma sterilized Hemashield cannula only The blood pump is packaged in a Tyvek M 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 36 Fr 12mm and 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 page 14 BVS 50001 Operator s Manual SECTION 5 INSTALLATION amp OPERATION 5 1 Installation Prior2. 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 ABIOMED Inc page 25 BVS 50001 Operator s Manual 8 7 Scheduled Maintenance 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 4 years Replace solenoid valves 700 hours of use Replace compressor 700 hours of use kk kkk Estimated initial useful console life 600 hours of use 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 an At end of console life remove the battery and recycle or dispose of properly Do not incinerate the battery as this could result in an explosion Dispose of the remaining console per applicable local regulations or contact your authorized ABIOMED representative Console estimated life may be extended by the manufacturer at a future date 8 8 BVS Replacement Parts Contact your aut
3. exposed to surges beyond its capability In this instance normal functioning of the console will continue but the loss of the surge suppression capability will be indicated The surge suppression capability has been exceeded when the System Fault light illuminates without blinking but there is no accompanying audible alarm The console should be repaired once a backup is obtained ABIOMED Inc page 22 BVS 50001 Operator s Manual Section 7 Console Failure 7 1 7 2 7 3 Foot Pump In the case of console failure the foot operated pump allows manual operation of the blood pump The foot pump is stored inside the front cover It can be removed for use after compressing the pedal A console failure is indicated by no air being pumped regardless of how the controls are operated Removing and Operating the Foot Pump a Turn off the console Open the front cover b Squeeze the pedal closed using the finger holes and the pedal strap and pull it out of the slot as shown in Figure 7 1 Figure 7 1 Removing the Foot Pump C Place the pump on a level floor Remove the drive lines from the console and reattach to the foot pump Either pump can be connected to any barb d Completely depress the pump with your foot 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 e Obtain a backup BVS cons
4. 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 several minutes before adjusting again This will allow the system to reach steady state before further adjustment To Start or Stop Pumping To start pumping Press the ON button for the appropriate side The pump will start to run at 75 BPM with a fixed rate operation To stop pumping Press the appropriate OFF button twice within thirteen seconds The button must be pressed twice to stop the pump This is a safety feature to prevent accidental operation A single press of the OFF button will be ignored after thirteen seconds 5 7 Battery Operation and Transport When the patient is transported the blood pump can be mounted to the bed The console is unplugged from the wall removed from mains voltage and rolled along with the patient The internal battery when fully charged will automatically power the console for a minimum of one hour The battery requires approximately 16 hours to charge after one hour of use ABIOMED Inc page 1 BVS 50001 Operator s Manual 5 7 1 Mounting the Blood Pump to the Accessory BracketError Bookmark not defined Two types of accessory brackets are available to mount the blood pump for transport Figure 5 2 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
5. to be 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 page 9 BVS 50001 Operator s Manual THIS PAGE LEFT BLANK INTENTIONALLY ABIOMED Inc page 10 BVS 50001 Operator s Manual SECTION 4 0 SPECIFICATIONS 4 1 BVS 50001 Transport Backup Console 4 1 1 Physical Width Depth Height Weight Operating Temperature Range Operating Humidity Range Operating Atmospheric Pressure Range Storage and Transport Temperature Range Storage and Transport Humidity Range Storage and Transport Pressure Range 16 3 inches 41 4 cm 11 2 inches 28 5 cm 36 4 inches 92 5 cm approximately 125 lbs 56 8 kg 10 C to 40 C 30 to 75 10 000 ft 700 hPa
6. to clinical use on site installation and testing of this Console shall be performed by an authorized ABIOMED Service Representative CAUTION Device must be plugged into AC outlet to maintain battery charge when not in use 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 ten seconds to complete During self test the console illuminates all indicators sounds the alarm tone and pumps air through the drive ports The operator should observe the control panel and sounds emanating from the device during the self test to detect any abnormalities BVS 50007 Transport Console pl BEAT RATE Hani Sg BEA O POWER RATE ny OFF ON RATE u ON AS ON ls ae a p m O ALARM ALARM 2 OFF Pl f VOLUME e mute e OFF f AS O SYSTEM i i PRESSURE Mea pi i aa R 0 ANTHIS UNIT MUST BE ATTENDED AT ALL TIMES DURING USE A ABIOMED INC Figure 5 1 BVS 50001 Control Panel a The handle on the top of the console can be extended to aid maneuverability of the unit Loosen the handl
7. BVS 50001 Operator s Manual ABIOMED BVS 50001 Bl VENTRICULAR SUPPORT SYSTEM TRANSPORT BACKUP CONSOLE 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 22 Cherry Hill Drive Danvers MA 01923 USA N America 1 800 422 8666 24 Hour Emergency Hotline or 978 777 5410 BVS 50001 Transport Backup Console UL 2601 1 Classifications Class 1 Equipment Type B Applied Part IPX1 Protection Continuous Operation 0050 9000 Rev C September 2002 ABIOMED Inc page 1 BVS 50001 Operator s Manual ABIOMED Inc and our authorized representatives 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 BVS 5000 is only used in accordance with the Instructions for Use Only use the BVS 50001 console with the BVS Blood Pumps BVS Cannulae and BVS Accessories Copyright 2000 2001 2002 by ABIOMED Inc All rights reserved ABIOMED BVS Angioflex and the AB logo are registered trademarks of ABIOMED Inc in the United States and trademarks of ABIOMED
8. Bi Ventricular Support System Atrial Arterial Cannulae Instructions for Use prior to operation See BVS 5000 Bi Ventricular Support System Blood Pump Instructions for Use prior to operation ABIOMED Inc 5 5 Interconnection Procedure page 16 BVS 50001 Operator s Manual 5 6 Pumping 9 6 1 9 6 2 9 6 3 Expected Flow Rates The specification reflects flows of gt 4 8 L Min for both right and left side under 10 mmHg of inflow pressure and outflow pressures of 40 mmHg and 90 mmHg respectively 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 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 O and 14 inches 35cm below the patient s atria If the pump is raised above the level of the patient s atria or
9. Inc in the other countries Additional trademarks registrations are being applied for in the U S and other countries Tyvek and Mylar are trademarks of E I Dupont de Nemours and Co Inc Hemashield is a trademark of Meadox Medicals Inc ABIOMED Inc page 2 BVS 50001 Operator s Manual TABLE OF CONTENTS Section 1 Introduction kl ZSYSIeEm OVE NEW en Sasviod a sata acaadaceesuctadeonte 5 1 2 BVS Bl004 PUM Devens mens ee Le et 5 IE SEN SU A ne a e eier 5 TA BV S GCOnSOle wigs A a Soe 6 tS ACC US tl li 6 Section 2 Indications For USGC ccccccccccccccccecececcececuccecscceucececcecucaeaueecseceuesecseaenerens 9 Section 3 Contraindications For US ccccccccceccecececcecececcccecececcecscecceceaucaeaececaees 10 Section 4 Specifications Al CONSO erg energie 11 42 BVS Blood Pump Specifieali ns nine si ei Era ei 13 Section 5 Installation and Operation 5 1 e e ER O EOI 15 52 Console Power Wp and Self Test enii eu ida e dee cOn do 15 53 BVS Blood Pump Preparallon ps 16 5 4 Recommended Cannulation Method scissa aa EE EEEE a E AA 16 9 9 interconnection Proced ra ica ltd erlassenen 16 9 6 PUMN o id 16 5 7 Battery Operation and TranSpOlt ooooonncnnccnnccccccnconnnnnnnnnnnnonononononnnnncnnnnnnnnnnnnnnnnnnnnnnnnnnnnnonononannnnnss 17 Section 6 Alarms and Status Indicators GA Introducir tasas a O id ici 20 6 2 Pressure ana Vacuum Alas a al dd ad 20 Da 212 1919 IM Ue iia 21 04 Ala
10. ation 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 50001 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 ABIOMED Inc page 31 BVS 50001 Operator s Manual THIS PAGE LEFT BLANK INTENTIONALLY ABIOMED Inc page 32 BVS 50001 Operator s Manual SYMBOL DEFINITIONS Alternating Current of Off Battery charger is active Direct current Protective earth UN Type B Applied Part h Dangerous voltage Equipotentiality Rechargeable battery Attention consult instructions Serial number Part number Protected against dripping water E Year of manufacture ABIOMED Inc page 33 BVS 50001 Operator s Manual THIS PAGE LEFT BLANK INTENTIONALLY ABIOMED Inc page 34 BVS 50001 Operator s Manual PATIENT TRANSPORT WITH THE BVS 50001 BI VENTRICULAR SUPPORT SYSTEM In some instance
11. ation when charged With AC power on Battery Low message is displayed if charge is less than 80 capacity ALARMS Pressure Fault Pressure Fault with Vacuum Fault and System Fault Battery Low Battery Fault System Fault ABIOMED Inc Obstruction of blood lines Blood Pump placed too high relative to atrium Inadequate blood volume Air line or blood pump lines kinked or occluded Disconnection or leak in air line Low batteries lt 30 min of battery power plug machine in or obtain backup BVS console Battery charging fault obtain backup BVS console Obtain backup BVS console page 29 BVS 50001 Operator s Manual THIS PAGE LEFT BLANK INTENTIONALLY ABIOMED Inc page 30 BVS 50001 Operator s Manual ABIOMED Inc BVS 50001 DOMESTIC LIMITED SERVICE WARRANTY ABIOMED Inc warrants that at the time of installation all BVS 50001 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 period 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 an
12. being careful not to kink or bend the blood or air tubing Close the sling around the pump by joining the 2 Velcro ends Attach the pump sling to the bed or stretcher using the mounting straps around the bed rail Adjust the pump height according to the instructions in 5 6 2 5 7 1 5 Attaching the BVS Blood Pumps to the console 1 ABIOMED Inc Connect the drive line from the blood pump to the respective right or left hose connector on the front of the console page 19 BVS 50001 Operator s Manual 5 7 2 5 7 3 ABIOMED Inc 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 3 shows the status of the battery Figure 5 3 Battery Status indicators Battery Charging green LED is illuminated when the console is plugged in Battery On yellow LED 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 Low red LED appears when a the line cord is connected and the battery is less than 80 charged or b when the line cord is disconnected and less than 30 minutes minimum of battery operation remains during battery operation A loud periodic three or four beep audible signal is produced to advise the operator of low battery status The operator should either plug in
13. ce is external to the patient and is intended for short term use 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 e Patients who fail to wean from cardiopulmonary bypass following heart surgery e 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 e 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 a Patient has a body surface area gt 1 3 m and is lt 75 years of age b Patient is in relatively good health other than the cardiovascular problem for which surgery was undertaken c 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 d 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 e Patient is unable
14. charging time before portable use The console is now ready for operation CAUTION CAUTION CAUTION CAUTION CAUTION Do not lean on or place any objects on the control panel Minimize the exposure of the console to sources of electromagnetic magnetic optical and thermal radiation Exposure to sources of electromagnetic radiation such as cell phones and walkie talkies or other types of radiation may cause operational interference To clear symptoms of interference turn off the interfering device The console should resume normal operation Minimize the exposure of the console to vibration and mechanical shocks during transport See section Patient Transport with the BVS 50001 Bi Ventricular Support System Lift the device over steps or obstructions Avoid activities that may build up static charges on the console or on personnel contacting the console Avoid brushing bed sheets across the console or touching the console immediately after performing activities likely to build static charge If electrostatic discharge interrupts operation of the console cycle the POWER ON OFF switch Operation of the console may interfere with the operation of other devices If this is suspected maximize the distance between the console and the device 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
15. d 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 inconsistent 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 transferable without the express written consent of ABIOMED Under this warranty ABIOMED will provide at no charge updates or modifications which directly affect the safe oper
16. e knob in a counter clockwise direction rotate the handle up and away from the unit until it stops Tighten the handle knob in a clockwise direction to lock the handle in place The handle can be rotated back to its position flush with the back of console when not needed b Unwrap the line cord and plug into an outlet Check that the Battery Charging indicator is lighted on the lower units front panel Where the integrity of the external protective conductor in the installation or its arrangement is in doubt the console shall be operated from its internal battery Activate the console with the power switch on the front panel The system will automatically begin to run its self test ABIOMED Inc page 15 BVS 50001 Operator s Manual c Check visible and audible machine functions Watch for illumination of all alarm and status lamps Figure 5 1 Red LEDs will illuminate for PRESSURE VACUUM and SYSTEM faults for pump OFF controls and in all segments of the BEAT RATE display Yellow LEDs will illuminate for RATE indicators and for the ALARM MUTE control Green LEDs will illuminate for pump ON controls Listen for the alarm tone The alarm will default to sound at its highest volume level Listen for valve actuation and the sound of air venting from the drive ports d Check the condition of the battery If the Battery Low indicator is illuminated the battery is not capable of providing a full hour s operation of the console Allow more
17. erations 1 Planning adequate space is crucial Console specifications include Weight approximately 125 lbs 56 8 kg height 36 4 inches 92 5cm width 16 3 inches 41 1 cm and depth 11 2 inches 28 5cm 2 Load as many pieces of ancillary equipment monitors ventilators etc into transport vehicle as possible before bringing patient down from the hospital Intensive Care Unit or Operating Room 3 Pull the foot pump out of the console prior to loading console into transport vehicle so that it will be readily accessible if it is needed 4 Load the console into the transport vehicle prior to loading the patient If necessary use the 6 ft tubing adapter to extend the tubing length during transport use Try to situate the console in a position where the display is readily visible Load patient into the vehicle feet first Monitoring the patient s condition will be through observation of clinical markers available on the ancillary patient monitor and visual observation of the blood pump filling Console has an average worst case power consumption of 400 watts Make sure that the vehicle is able to provide the necessary power 5 Make sure battery is fully charged prior to transport 6 Satisfactory operation should be expected from a nominal 120 Vac 60 Hz sine wave source with a minimum of 500 watt capacity or from a 120 Vac 60 Hz quasi sine or modified sine wave source e g Vanner Model 20 1000TUL A clipped sine wave inv
18. erter can also be used A square wave source should not be used Remember that the foot pump is available for use if needed 7 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 ABIOMED Inc page 35 BVS 50001 Operator s Manual 8 9 10 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 foot pump is available for use if needed Fasten the console to the ambulance aircraft with appropriate straps or fixture to prevent movement Examples of Additional Equipment to Consider ls END Power strips for extra outlets for use with equipment other than the BVS 5000 system Extra oxygen tanks Bed Mount for BVS 5000 Blood Pump Sterile gloves tubing clamps irrigation bowl irrigation syringe and sterile sponges Nylon straps to secure console BVS 2 sets of blood pump tubing covers ABIOMED Inc page 36
19. h cycles between three levels of alarm volume Console defaults to the loudest level upon startup 6 5 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 The console will issue a two beep audible indication every minute while operating on battery If the battery system enters the LOW condition the indication becomes a louder four beeps every 15 seconds Battery Charging Illuminated when console is Normal plugged in Battery On Line cord disconnected and Expect less than one hour console running on battery operation on battery power Battery Low Illuminated when a the line Plug in console if cord is disconnected and less disconnected and rd until than 30 minutes of battery light is extinguished or operation remain or b the line obtain a backup cord is connected and the battery is less than 80 charged Battery Fault Illuminated when system has Plug in console and wait automatically shut down in until battery charged gt 16 battery mode hours or obtain a backup Battery Fault with Battery Illuminated when battery Contact Service and obtain Charging requires service backup console Table 6 2 Battery status indicators 6 6 Surge Protection Status The BVS console has an internal device used for AC surge suppression The device will self sacrifice if
20. horized ABIOMED representative for spare parts list 8 9 Service For service contact North America ABIOMED Inc 22 Cherry Hill Drive Danvers Massachusetts 01923 978 777 5410 800 422 8666 ABIOMED Inc page 26 BVS 50001 Operator s Manual 8 10 Ordering Information BVS Equipment Catalog Number Description Mains voltage 0050 0000 BVS 50001 Console 120 VAC 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 0050 9010 BVS 50001 Console 1 per box Service Manual English only 0050 3200 BVS Blood Pump Sling 1 Per box 0050 3240 BVS 50001 Mounting Plate 1 Per box 0505 3170 BVS Blood PumpTubing Covers 1 Per Box BVS Disposables Blood pump sets Blood Pump with select Cannula and individual Cannula are available Contact your representative or call 1 800 422 8666 ABIOMED Inc page 27 BVS 50001 Operator s Manual THIS PAGE LEFT BLANK INTENTIONALLY ABIOMED Inc page 28 BVS 50001 Operator s Manual OPERATING INSTRUCTIONS PLACARD 1 Turn power ON switch on front and line cord on top 2 Wait for self test to finish 3 Connect pneumatic line s from disposable at front 4 To start pumping depress appropriate ON button 5 To stop pumping depress OFF button twice within thirteen seconds Battery Battery activated by disconnecting line cord provides approximately one hour of oper
21. le supplies pneumatic power to a disposable blood pump The beat rate and systolic diastolic intervals are fixed The ABIOMED BVS 50001 is indicated for use as a backup console for either an ABIOMED BVS 5000 Bi Ventricular Support System or an ABIOMED BVS 5000 Bi Ventricular Support System It can also be used to facilitate patient transport The device requires constant monitoring by a trained operator 1 2 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 a Figure 1 1 BVS Blood Pump 13 BVS Cannulae Refer to Instructions for Use There are 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 coating on the graft eliminates the need fo
22. n 5 2 for more details Separating Upper and Lower Modules not recommended Although it is not recommended the upper module can be separated from the lower module when not in use as needed Unscrew the cable connecting the two modules screw the protective cap onto the upper module connector and disconnect the three latches securing the top module to the bottom The upper unit can now be separated from the lower unit allowing the two modules to be moved separately Reattach and reconnect the two modules when done and plug the upper unit into an outlet The upper module will not maintain the charge of the battery in the lower module if the connector between the units is left disconnected 8 5 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 Plug the line cord into an outlet Turn on the power switch Check the illuminated panel indicators substitute crate and packing instructions 8 6 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 detergent with a wet sponge is suggested for the console enclosure if necessary
23. nough 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 See section 5 6 2 Instead of pointing down the central adjustment lever will now be pointing towards the 12 o clock position 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 5 7 1 3 To attach the BVS Blood Pumps to the Pole MountError Bookmark not defined A long plastic plate is attached to the back of the blood pump At the top of this plate slightly above the upper inflow bladder is a square backplate designed to slide into the blood pump bracket 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 Slide the backplate into one of the blood pump brackets from the top down Make sure that both edges of the blood pump bracket fully engage the blood pump back plate to ensure that it is attached securely Adjust the pump height according to the instructions in 5 6 2 5 7 1 4 To attach the BVS Blood pumps to the BVS Blood Pump Sling gt Always hold the pump below the patient s heart Lay the pump into the sling
24. ole Power it up and allow the self test to run Begin pumping by pressing the ON button Transfer the drive lines from the failed console to the backup f Call service personnel at the earliest opportunity to repair the failed console Stowing Foot Pump a Squeeze the pump closed and slide it into the slot Close the front cover ABIOMED Inc page 23 BVS 50001 Operator s Manual THIS PAGE LEFT BLANK INTENTIONALLY ABIOMED Inc page 24 BVS 50001 Operator s Manual SECTION 8 ROUTINE MAINTENANCE AND SHIPMENT 8 1 Routine Check of Backup Systems It is recommended that the BVS console emergency systems be checked out regularly This should be done on the day previous to transport and during preventive maintenance The procedure is to test the foot pump and run the regular power up self test 8 2 Foot Pump Test With the unit off open the front 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 8 3 Self Test Routine Assure that all indicator lights work and that the alarm tone sounds Listen for valve actuation and for the sound of air venting from the pump connections The display should display no pressure vacuum or system faults If any of these faults is indicated or if the Battery Fault is illuminated consider the unit inoperable Obtain a backup unit and call qualified service personnel immediately Refer to Sectio
25. pe 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 AP Drive medium applied to bladder Housing material Patient connections Blood Pump inflow ABIOMED Inc Right amp left side lt 80 mmHg or gt 10 mmHg vacuum Displayed when a line cord is connected and battery lt 80 charged or b line cord is disconnected and less than 30 minutes of battery time remains This is the minimum time remaining when Battery Low first comes on System has automatically shut down in battery mode or battery requires service if Fault LED accompanies Battery Charging LED 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 mHg gt 325 mmHg gt 410 mmHg lt 6 5 mmHg at 10L min Compressed air Class VI medical grade polycarbonate 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 page 13 ABIOMED Inc BVS 50001 Operator s Manual Blood Pump outflow Atrial cannula Supplied with Cannula restraint tunneling bullet and tie wraps
26. r preclotting and provides a graft porosity lt 1cc min cm ABIOMED Inc page 5 BVS 50001 Operator s Manual 1 4 BVS 5000 Transport Backup Console The BVS 50001 Console Figure 1 2 is a logic device controlled pneumatic drive system which can operate one or two disposable blood pumps The console operates at a fixed beat rate and systolic diastolic ratios Beat rate is 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 Alarms alert the operator to abnormal flow or pressure conditions The console also has a level of operational redundancy Should the console fail a foot operated pump allows continued support lt also has a failsafe battery back up system to provide a minimum of one hour of operation should AC Mains power fail Figure 1 2 BVS System 50001 Transport Backup Console 1 5 Accessories Pole Mount Refer to Instructions For Use Section 5 7 1 The BVS I V Pole Mount is provided as a mounting bracket for the BVS Blood Pump while in use lt attaches to an I V pole and can accommodate two blood pumps Bed Mount Refer to Instructions For Use Section 5 7 1 The BVS Bed Mount is also an accessory that can be used to sec
27. rmi A 21 65 UY WS a o A a a 21 60 Surge Prolecu n Status riimien old 22 Section 7 Console Failure lek POOL PUMDees ee enlarge 23 7 2 Removing and Operating the Foot PUMP ooocccnncnncnnnnncccccncnnnononnnnnnnnnnnnononononnnnnnnnnnnnnnnnnnnnnnnnnnnas 23 Toa SOWNO FOOL UNM Desierta laredo tibia ici ns 23 Section 8 Routine Maintenance and Shipment 8 1 Routine Check of Backup SNS o o 25 82 ROO RUMD IES A daa 25 A ern enseeeeeede 25 8 4 Separating Upper and Lower Modules ccccccccccooocononccnnononcnocononononocononnnononononnonnnnnnnnonononinnnos 25 8 9 Packaging for Shipment zu 2 ee 25 A A ee a 25 8 7 scheduled Maintenance nenn 26 8 8 BVS Replacement Pal Saa iia 26 8 9 E O ech 26 AE e ee a ae 27 Operating Instruction Placaro coccccccccoocccconccocononononononnonnnnnnnnnnononononnnnnnnnnnnnnnonononnnnnannnnnnons 29 Symbol Delihitions 2222er A ee ee eee 33 Patient Transport with the BVS 500006 Bi Ventricular Support System 35 ABIOMED Inc page 3 BVS 50001 Operator s Manual THIS PAGE LEFT BLANK INTENTIONALLY ABIOMED Inc page 4 BVS 50001 Operator s Manual SECTION 1 INTRODUCTION 1 1 System Overview The ABIOMED BVS 5000 Bi Ventricular Support System is an automated bi ventricular support device intended to provide short term support of the left and or right sides of the heart The system drive console the BVS 50001 Transport Backup Conso
28. s 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 Blood Pump considerations 1 The top of the blood pump should be level with or below the patient s atrium to give good flows Use of the BVS 50001 allows the blood pump to be mounted in a horizontal orientation Remember that pump filling is identical to the BVS 50001 and is accomplished by gravity and the patient s preload 2 Ensure that the Blood Pump is not damaged during transport by providing adequate clearance 3 Check the driveline s that connect the blood pump to the console Make sure there are no kinks 4 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 Again make sure that there are no kinks 5 Use of BVS bed mount or BVS blood pump sling rather than IV pole may make maneuvering the blood pumps easier Console consid
29. sure regulated to 320 mmHg Right line pressure regulated to 200 mmHg Left and right vacuum regulated to 38 mmHg vacuum Pressing Left or Right ON button initiates pumping Pressing Left or Right OFF button twice within 13 seconds typical ceases pumping Silences audible alarm for one minute except for battery operation which has a separate alarm Cycles alarm volume through three levels Blood pump interface 1 4 in 6 mm I D hose barb Filling and emptying of disposable is controlled by operator placement of the blood pump 75 1 BPM With 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 8 L min at outflow pressure of 40 mmHg and inflow pressure of gt 10 mmHg Left side lt 250 mmHg during systole Right side lt 160 mmHg during systole Right amp left side lt 25 mmHg during early diastole vacuum Right amp left side gt 20 mmHg during vent after diastole vacuum Left side lt 250 mmHg or gt 360 mmHg Right side lt 135 mmHg or gt 240 mmHg Right amp left side gt 25 mmHg during late diastole vacuum Right amp left side lt 10 mmHg during vent after diastole vacuum page 12 BVS 50001 Operator s Manual Vacuum Fault and System Fault Battery Low Battery Fault 4 1 8 Backup System Foot Pump 4 2 BVS Blood Pump Specifications Parameter _ No of bladders No ty
30. the console line cord or obtain a backup console Battery Fault red LED appears when the system has automatically shut down in battery mode The operator should plug in console and wait until the battery has fully charged gt 16 hours or obtain a backup console Battery Fault red LED with Battery Charging green LED indicates that the battery requires service The operator should obtain a backup console and contact Service Preparing the Console for Transport Battery operation is automatically activated by unplugging the line cord When ready for transport unplug the line cord and wind it around the top handle Roll the console carefully to avoid kinking or disconnection of the drive line To carry the console over obstacles grasp the handles at the sides top or bottom page 20 BVS 50001 Operator s Manual SECTION 6 ALARMS AND STATUS INDICATORS 6 1 Introduction The BVS console provides alarms for incorrect pressure vacuum or flow levels These alarms appear on the front panel Status indicators of the battery system are located on the lower unit The BVS console also provides an indication of the surge suppression functional status on the front panel 6 2 Pressure and Vacuum Alarms The pressure and vacuum alarms Table 6 1 are derived from the pressure within the drive line to the blood pump and the supply pressures and vacuum leading to the drive line These pressures are measured inside the BVS console Pressure alarms
31. to 1000 ft 1060 hPa 15 to 50 C 10 to 95 18 000 ft 500 hPa to 1000 ft 1060 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 performance 4 1 2 Electrical Mains voltage Mains frequency Mains current Average power consumption Line leakage current Power cable Battery 4 1 3 Mechanical System Drive medium ABIOMED Inc 120 VAC 60 Hz 3 3 A maximum at 120 V lt 400 W Less than 300 UA at any input voltage 11 ft 3 4 m of 16 AWG Type SJT hospital grade plug Internal 12 V battery provides 1 hour operating time when fully charged Charging time is less than 16 hours to full charge after 1 hour of use Compressed air page 11 BVS 50001 Operator s Manual Drive technology 4 1 4 Operator Controls Pump controls Alarm mute Alarm volume 4 1 5 Outputs LEFT and RIGHT device output 4 1 6 Pumping System Control General Pumping rate Flow Rate 4 1 7 Alarm Limits Pressure Fault no System Fault Pressure Fault and System Fault Vacuum Fault no System Fault ABIOMED Inc Compressor system drives independent pressure regulated systems Switching from a pressurized to a non pressurized state in the blood pump is via independent 3 way solenoid valves Return air is allowed to vent to atmosphere or vacuum Left line pres
32. under the patient s mattress Figure 5 2 Blood Pump accessory mounting brackets A third option is a BVS Blood Pump Sling This sling allows for the pump to be operated in a horizontal position for transporting the patient The sling is transparent and has attachment straps for mounting the pump to the bed or stretcher 5 7 1 1 To attach the BVS Pole Mount to the I V pole Error Bookmark not defined 1 Unscrew the screw clamp enough to fit the clamp around the I V pole 2 Tighten the screw clamp onto the I V pole by turning the black knob clockwise 3 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 4 Move the Pole Mount up or down with the handle to the desired position 5 Turn the central adjustment lever clockwise back to its original position to secure the Pole Mount in place 5 7 1 2 To attach the BVS Pole Mount to the Bed Mount 1 Hold the bed plate so the metal post faces up 2 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 3 The weight of the mattress and the patient will hold the Bed Mount Plate in ABIOMED Inc page 18 BVS 50001 Operator s Manual 9 place Hold the Pole Mount by the handle Unscrew the screw clamp e
33. ure the blood pump during patient transport lt 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 ABIOMED Inc page 6 BVS 50001 Operator s Manual BVS Blood Pump Sling See instructions for Use later in patient transport section This accessory is only used with the BVS 5000t It allows for horizontal positioning of the blood pump attached to the stretcher or bed Pump Mount Set Includes Pole and Bed Mounts as described above ABIOMED Inc page BVS 50001 Operator s Manual THIS PAGE LEFT BLANK INTENTIONALLY ABIOMED Inc page 8 BVS 50001 Operator s Manual SECTION 2 0 INDICATIONS FOR USE The BVS 5000t is indicated for use as a backup console for either an ABIOMED BVS 5000 Bi Ventricular Support System or an ABIOMED BVS 5000 Bi Ventricular Support System It can also be used to facilitate patient transport The BVS 5000 systems are indicated 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 devi
34. will typically indicate an external problem such as a blocked drive line or blood line or indicate that blood pump placement is at the wrong height relative to the patient Activation of the alarms will result in flashing of the alarm LEDs alternating with flashing of the 75 beat rate display THE BVS 5000t WILL ALWAYS ATTEMPT TO MAINTAIN PUMPING THROUGH ANY ALARM CONDITIONS THAT IT ENCOUNTERS Alarm Message Effects Probable Causes Pressure Fault Low flow due to obstruction of blood lines blood pump placed too high relative to atrium inadequate blood volume drive line or blood pump lines kinked or occluded Low flow due to Pressure Fault with Vacuum Fault and System Fault e disconnection or leak in drive line Pressure Fault with System Fault e incorrect internal supply pressures Vacuum Fault with System Fault e incorrect internal supply vacuum Table 6 1 Pressure and Vacuum alarms CAUTION Obtain a backup console if all of the external faults above have been checked and these alarms continue to occur ABIOMED Inc page 21 BVS 50001 Operator s Manual 6 3 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 6 4 Alarm Volume Pressing the alarm volume switc
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