Bio-Pump+™ BPX-80, CBBPX-80
0123
Centrifugal Blood Pump; with or without Cortiva™ BioActive Surface
Bomba centrífuga de sangre con o sin superficie biocompatible
Cortiva™
Pompe sanguine centrifuge ; avec ou sans surface bioactive
Cortiva™
Instructions for Use • Instrucciones de uso • Mode d'emploi
Caution: Federal law (USA) restricts this
device to sale by or on the order of a
physician.
The following list includes trademarks or registered trademarks of Medtronic in the United
States and possibly in other countries. All other trademarks are the property of their respective
owners.
La siguiente lista incluye marcas comerciales o marcas registradas de Medtronic en los
Estados Unidos y posiblemente en otros países. Todas las marcas comerciales son propiedad
de sus propietarios respectivos.
La liste suivante inclut des marques commerciales ou des marques déposées de Medtronic
aux États-Unis et eventuellement dans d'autres pays. Toutes les autres marques
commerciales sont la propriété de leurs détenteurs respectifs.
Bio-Console, Bio-Pump+, Cortiva, Medtronic
Explanation of symbols • Explicación de los símbolos • Explication des
symboles
Refer to the outer package label to see which symbols apply to this product. •
Consulte la etiqueta del envase exterior para comprobar qué símbolos son
aplicables a este producto. • Se référer à l’étiquette sur l’emballage extérieur
pour savoir quels symboles s’appliquent à ce produit.
Authorized representative in the European Community •
Representante autorizado en la Comunidad Europea • Représentant
autorisé dans la Communauté européenne
Catalog number • Número de catálogo • Numéro de référence
Conformité Européenne (European Conformity). This symbol means
that the device fully complies with applicable European Union acts. •
Conformité Européenne (Conformidad Europea). Este símbolo
indica que el dispositivo cumple totalmente las leyes vigentes de la
Unión Europea. • Conformité Européenne. Ce symbole signifie que
l’appareil est entièrement conforme aux lois en vigueur de l’Union
européenne.
Consult instructions for use • Consultar instrucciones de uso •
Consulter le mode d’emploi
Date of manufacture • Fecha de fabricación • Date de fabrication
Do not resterilize • No reesterilizar • Ne pas restériliser
Do not reuse • No reutilizar • Ne pas réutiliser
Do not subject to impact or rough handling • No someter a impactos
o manipulación brusca • Ne pas soumettre à des chocs ou à une
manipulation brutale
Do not use if package is damaged • No utilizar si el envase está
dañado • Ne pas utiliser si l’emballage est endommagé
For US audiences only • Solo aplicable en EE. UU. • Ne s’applique
qu’aux États-Unis
Lot number • Número de lote • Numéro de lot
Manufactured in • Fabricado en • Lieu de fabrication
Manufacturer • Fabricante • Fabricant
Nonpyrogenic fluid path • Vía de líquido apirógena • Trajet des fluides
apyrogène
3
Open here • Abrir aquí • Ouvrir ici
Quantity • Cantidad • Quantité
Serial number • Número de serie • Numéro de série
Sterilized using ethylene oxide • Esterilizado mediante óxido de
etileno • Stérilisé à l’oxyde d’éthylène
Transit temperature limit • Límite de temperatura de transporte •
Limite de température de transport
Use-by date • Fecha de caducidad • Date de péremption
4
Figure 1. • Figura 1. • Figure 1.
EN
ES
FR
1 Outlet
2 Inlet
1 Salida
2 Entrada
1 Sortie
2 Entrée
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1 Description
The Bio-Pump+ centrifugal blood pump is sold one of 2 ways:
• Uncoated (BPX-80)
• With Cortiva bioactive surface (CBBPX-80)
The device is intended for use in extracorporeal circulation procedures and is
designed to move blood by centrifuge force created by smooth rotating cones.
These smooth cones rotate in a housing designed by computational fluid
dynamics (CFD) to minimize trauma to the blood. Energy is transferred from
the cones to the blood in the form of pressure and velocity as the blood is gently
accelerated toward the outlet of the blood pump. The nonocclusive
hemodynamic design of the blood pump promotes laminar flow, allowing for
improved blood handling capabilities and decreasing trauma that may be
associated with extracorporeal circulatory support during cardiopulmonary
bypass.
The blood pump couples to a safety-locked magnetic drive unit called the
external drive motor (Model 540T), which is controlled by a Medtronic
Bio-Console pump speed controller. The external drive motor and
Bio-Console pump speed controller serve as the hardware components of the
Medtronic extracorporeal blood delivery system.
The blood pumps have been sterilized using ethylene oxide.
Products coated with Cortiva bioactive surface include a “CB” prefix in the
model number. Additional information regarding Cortiva bioactive surface is
available in Chapter 7.
2 Indications for use
The Medtronic Bio-Pump+ centrifugal blood pump is indicated for use only
with the Medtronic Bio-Console pump speed controller to pump blood through
the extracorporeal bypass circuit for extracorporeal circulatory support for
periods appropriate to cardiopulmonary bypass (up to 6 hours). It is also
indicated for use in extracorporeal support systems (for periods up to 6 hours)
not requiring complete cardiopulmonary bypass (for example, valvuloplasty,
circulatory support during mitral valve reoperation, surgery of the vena cava or
aorta, liver transplants).
3 Contraindications
The Medtronic centrifugal blood pumping system is contraindicated as a
cardiotomy suction device.
Use the device only as indicated.
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4 Adverse effects
The following known adverse effects are associated with the use of the
product: blood loss, coagulopathy, death, embolism, excessive blood
component activation or thrombogenicity, exsanguination, hemolysis,
hemolytic anemia, infection, ischemia, neurological dysfunction, and organ
dysfunction.
5 Warnings
• The blood pump has not been qualified through in vitro, in vivo, or clinical
studies for long-term use (longer than 6 hours) as a bridge-to-transplant or
for pending recovery of the natural heart.
• Read all warnings, precautions, and instructions for use carefully before
use. Failure to read and follow all instructions or failure to observe all stated
warnings could cause serious injury or death to the patient.
• Possible side effects include, but are not limited to, infections, mechanical
failure, hemolysis, and thromboembolic phenomena. These are potential
side effects with all extracorporeal blood systems.
• Ensure that the blood pump and the circuit have been debubbled and
primed properly before beginning bypass to minimize the risk of air
reaching the patient. The use of an arterial filter is recommended.
• Massive air entry into the centrifugal blood pump deprimes the pump and
stops blood flow. Stop the pump and remove air before resuming
circulation.
• Do not expose the centrifugal blood pump to liquid chemical agents,
because they may affect the integrity of this device. Anesthetic liquids,
such as isoflurane, are known to degrade polycarbonate plastics. Avoid
contact of these solutions with the centrifugal blood pump.
• To prevent retrograde blood flow when the blood pump outlet tubing is
open, establish and maintain a minimum pump speed that overcomes line
and patient resistance. Failure to do this could allow retrograde flow and
exsanguinate the patient.
• Clamp the arterial lines when the blood pump is at rest to prevent
retrograde flow.
• The blood pump is designed to be operated only with the Medtronic
Bio-Console pump speed controller. There is no safety or performance
data known to Medtronic which establishes compatibility of any other
manufacturer’s devices or components to the Medtronic system. Run the
blood pump only on a properly maintained Bio-Console pump speed
controller.
• Evaluate potential risk to the patient before changing the blood pump.
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English
• Frequent patient and device monitoring is recommended; do not leave the
centrifugal blood pump unattended while in use. Monitor the flow rate
carefully for signs of occlusion throughout the circuit.
• Do not operate the centrifugal blood pump for more than 30 s in the
absence of flow. The temperature within the pump could rise and
increased cellular damage may result.
• The centrifugal blood pump must be handled using aseptic technique.
• Do not operate the blood pump with its inlet clamped. This will generate
negative pressure in the blood pump and could cause air bubbles to form
in the blood.
6 Precautions
• This device should be used only by clinicians thoroughly trained in
extracorporeal circulation procedures.
• Do not forcefully strike or drop the centrifugal blood pump. Shock may
cause damage to the device, which may cause the device to malfunction.
• The fluid pathway of the centrifugal blood pump is sterile and
nonpyrogenic. Inspect the device and package carefully before use. Do
not use if the unit package or the product has been damaged or soiled, or
if caps are not in place.
• This device was designed for single patient use only. Do not reuse,
reprocess, or resterilize this product. Reuse, reprocessing, or
resterilization may compromise the structural integrity of the device and
create a risk of contamination of the device, which could result in patient
injury, illness, or death.
• Attach tubing in a manner that prevents kinks or restrictions that may alter
flow.
• Do not operate the centrifugal blood pump unprimed; damage to the
internal components will occur.
• Do not use the blood pump if dropped. Shock may cause damage to the
device, which may cause device malfunction.
• Do not use excessive force to install tubing on the pump because damage
to the pump might occur.
• Take care to prevent damage to connectors when repositioning or
attaching tubing.
• Always have a spare blood pump near and backup equipment available
with appropriate protocol for change out.
• Do not place the centrifugal blood pump near items adversely affected by
magnetic fields.
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• Follow a strict anticoagulation protocol and routinely monitor
anticoagulation during all procedures.
• It is the user’s responsibility to dispose of the devices in accordance with
local regulations and hospital procedures.
7 Information for products with Cortiva bioactive surface
The primary blood-contacting surfaces of the product are coated with Cortiva
bioactive surface. This coated surface enhances blood compatibility and
provides a blood-contacting surface that is thromboresistant. Cortiva bioactive
surface contains nonleaching heparin derived from porcine intestinal
mucosa1.
Caution: Product coated with Cortiva bioactive surface is intended for single
use only. Resterilization may adversely affect the Cortiva bioactive surface.
Caution: Follow a strict anticoagulation protocol and routinely monitor
anticoagulation during all procedures.
8 Recommended priming procedures
1. Using accepted aseptic technique, attach the appropriate tubing to the
inlet and the outlet of the blood pump.
Note: Applying a sterile saline solution to the inlet and outlet connectors
may aid tubing attachment.
2. Where practical, flush the circuit and the blood pump with CO2 (from filter
or reservoir bag).
3. Using gravity, fill the blood pump with priming solution to a point beyond
the flow probe and clamp. Eliminate air from the device by “walking” the air
out of the outlet.
Caution: Do not hit or strike the blood pump with hands or instruments.
Shock may cause damage to the device, which may cause device
malfunction.
Warning: Ensure that the blood pump and the circuit have been
debubbled and primed properly before initiating bypass to minimize the
risk of air reaching the patient. The use of an arterial filter is
recommended.
Warning: Massive air entry into the blood pump will cause it to deprime
and blood flow to stop. Stop the blood pump and remove the air before
resuming circulation.
1
Nonleaching is defined as heparin at a level ≤0.1 IU/mL, as measured
through clinically relevant extraction conditions.
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4. With the outlet clamped, turn the Bio-Console pump speed controller
power “ON.”
5. Zero (gain and balance) the flow probe according to the Bio-Console
Operator and Reference Manual.
6. With the outlet still clamped, turn the RPMs of the Bio-Console pump
speed controller to maximum RPM for 30 s. This delivers maximum
pressure within the blood pump, which aids in ensuring its integrity.
Observe the blood pump for leakage or other anomalies.
Warning: Do not operate the blood pump for more than 30 s in the
absence of flow. The temperature within the blood pump will rise and
increased cellular damage may result.
7. Bring the RPMs to zero and recheck the integrity of the blood pump.
Warning: If leaks or other anomalies are found, remove the blood pump
and replace with a new, sterile blood pump, repeating the above steps to
prime.
8. If no anomalies are noted, continue priming the circuit.
9. Verify all connections and the integrity and flow of the circuit before use.
Warning: Do not operate the blood pump with its inlet clamped. This will
generate negative pressure in the blood pump and could cause air
bubbles to form in the blood.
9 Prebypass checklist
Information from this blood pump bypass checklist can be used to revise,
upgrade, or expand existing checklists appropriately.
9.1 Equipment assembly
• Mount the motor drive correctly relative to the venous reservoir.
• Ensure that all of the electrical connections are secure.
• Test the control module power and display.
• Check the date and integrity of the sterile blood pump and disposable
probe packages.
• Ensure that the flow transducer and the disposable probe are sized
properly.
• Assemble the perfusion circuit in a sterile manner.
• Allow sufficient tubing length for the standby pumping unit.
• Connect the flow transducer and the disposable probe to the circuit in the
correct location and flow direction.
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9.2 Prime blood pump and circuit
• CO2 flush the blood pump and the circuit, if indicated; turn off the CO2.
• Gravity prime and debubble the blood pump and the perfusion circuit.
• Check the blood pump for leaks, irregular motion, and noise.
• Check the circuit for visible air.
• Ensure that all of the tubing connections are secure.
• Clamp the blood pump outlet line completely.
• Clamp the venous return line completely.
9.3 Operating parameters
• Calibrate the transducers according to the manufacturer’s instructions.
• Set and verify the low and high flow alarms.
9.4 Emergency backup equipment
Ensure that the following equipment is available:
• Backup power
• Handcrank (Model 150)
• Spare blood pump and disposable probe
• Control module or roller pump
9.5 Perfusion
• Achieve minimum pump flow before unclamping lines.
• Monitor the control module for messages and alarms.
• Monitor the perfusion circuit for visible air.
• Maintain minimum pump flow before clamping lines.
9.6 Cleanup
• Turn off the power.
• Properly discard disposable components.
• Cover the magnetic motor drive.
• Clean the console and the transducer.
9.7 Check equipment
• Inspect and verify that the equipment is operational.
• Maintain the indicated preventative maintenance schedule.
• Ensure that the batteries are charged to full capacity.
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10 Specifications
Priming volume
(approximate)
Inlet/outlet I.D. 9.5 mm (3/8 in) Maximum blood
Maximum operating pressure
86 mL Maximum flow
rate
pump speed
1100 mmHg
(147 kPa)
Compatible systems
10.1 Storage and transport environment
Maximum transit temperature:
• BPX-80: 50°C (122°F)
• CBBPX-80: 40°C (104°F)
10 L/min
4500 rpm
Bio-Console
pump speed controllers (with
external drive
motor Model
540T and emergency handcrank
Model 150)
Store the product at room temperature.
11 Additional information
The following information and data are available upon request: test methods
used to determine coverage, leaching, and bioactivity.
12 Limited warranty
The following LIMITED WARRANTY applies to United States customers only:
A. This LIMITED WARRANTY is available solely to the original purchaser of
the Bio-Pump+ centrifugal blood pump, Models BPX-80 and CBBPX-80
(hereinafter, referred to as “Product”).
(1) In the event that the Product fails to function within normal
tolerances due to a defect in materials or workmanship within a
period of one (1) year, commencing with the delivery of the Product
to the purchaser, Medtronic will at its sole option: (a) repair or
replace any defective part or parts of the Product; (b) issue a credit
2
2
This LIMITED WARRANTY is provided by Medtronic, 710 Medtronic
Parkway, Minneapolis, MN 55432. It applies only in the United States.
Areas outside of the United States should contact their local Medtronic
representative for exact terms of the LIMITED WARRANTY.
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