Thoratec PediMag User manual

PediMag®Blood Pump
Instructions For Use (IFU)
READ ENTIRE CONTENTS PRIOR TO USING THE BLOOD PUMP
THIS PRODUCT IS LABELED FOR USE OUTSIDE THE UNITED STATES.
IT IS NOT AVAILABLE AS LABELED IN THE UNITED STATES.
Thoratec Clinical & Technical Support Phone number(s)
United States Emergency HeartLine™ USA: Thoratec Corporation
Main Switchboard:
Tel: [phone]
Tel: [phone]
Fax: [phone]
Outside United
States
Emergencies outside USA:
Urgent/24-Hour Europe:
Thoratec Switzerland
Main Switchboard:
Tel: [phone]
Tel: [phone]
Tel: [phone]
Fax [phone]
Manufacturer:
Thoratec Switzerland GmbH
Technoparkstrasse 1
CH-8005 Zürich
Switzerland
www.thoratec.com
US Headquarters:
Thoratec Corporation
6035 Stoneridge Drive
Pleasanton, CA 94588
USA
www.thoratec.com
PL-0112, Rev 04
October 2013
DCO No 13-080

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© 2013 Thoratec Switzerland GmbH – Document No PL-0112, Rev 04 (October 2013)
SUPPLIED STERILE AND READY FOR USE – DO
NOT USE IF PACKAGING IS DAMAGED OR ANY
STERILE SEALS ARE BROKEN.
WARNING (Definition)
Warnings are used if there is a potential
for a serious hazard with misuse of the
device, when special attention is
required for safety of the patient, or
when special care should be exercised
to prevent improper operation of the
device that may cause damage.
CAUTION (Definition)
Cautions are used to alert the user to
exercise special care for the safe use of
the device.
DESCRIPTION
The PediMag Blood Pump has an impeller that
imparts rotary motion to the incoming blood, directing
it through the outflow port. The PediMag Blood Pump
is designed to allow improved blood handling and to
decrease trauma, which may be associated with
extracorporeal circulatory support during
cardiopulmonary bypass, by magnetically levitating
the impeller and by eliminating seals and bearings.
Figure 1 – PediMag Blood Pump
The PediMag Blood Pump couples to a magnetic
drive motor which is connected to the CentriMag
console.
INDICATIONS FOR USE
The PediMag Blood Pump is indicated for use with
the CentriMag Console and Motor to pump blood
through a complete extracorporeal bypass circuit for
extracorporeal circulatory support for periods
appropriate to cardiopulmonary bypass (up to six
hours) for surgical procedures such as a mitral valve
reoperation. It is also indicated for use in
extracorporeal support systems (for periods up to six
hours) not requiring complete cardiopulmonary
bypass (e.g. valvuloplasty, surgery of the vena cava
or aorta, liver transplants etc.).
The PediMag Pump can generate a maximum pump
flow equal to 1.5 liters per minute, limiting its use to
pediatric patients.
The PediMag Blood Pump is indicated for use only
with the CentriMag Console and Motor.
CONTRAINDICATIONS
The PediMag Blood Pump is contraindicated for use
as a cardiotomy suction device. It is also
contraindicated for patients who are unable or
unwilling to be treated with heparin or an appropriate
alternative anticoagulation.
INSPECTION PRIOR TO USE
1. The package containing the blood pump should
be inspected prior to use for any damage to the
sterile barriers. The package seals should be
intact to insure sterility. Do not use the Blood
Pump if the package is damaged. Contact
Thoratec regarding return of any damaged
product.
2. The Blood Pump should be inspected prior to
use for any damage or particulate matter
contamination. Do not use the Blood Pump if
damaged or if any particulate matter is found on
or inside the Blood Pump. Contact Thoratec
regarding return of any suspect Blood Pump.
WARNINGS
1. The PediMag Blood Pump has not been qualified
through in vitro, in vivo, or clinical studies for long
term us (i.e., longer than six hours) as a bridge to
transplant, for pending recovery of the natural
heart or for extracorporeal membrane
oxygenation.
2. Carefully read all Warnings, Precautions,
Manuals, and Instructions for Use for this and all
related Thoratec extracorporeal devices prior to
use. Failure to read and follow all instructions, or
failure to observe all stated warnings, could
cause serious injury or death to the patient.
Inlet port
Outlet port

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© 2013 Thoratec Switzerland GmbH – Document No PL-0112, Rev 04 (October 2013)
3. Possible side effects include, but are not limited
to: infection, mechanical failure, hemolysis, end
organ dysfunction, neurologic dysfunction,
bleeding, and embolic phenomena. These are
potential side effects with all mechanical
circulatory support systems.
4. Ensure that the PediMag Blood Pump and circuit
have been debubbled and primed properly prior
to use to minimize the risk of air entry to the
patient. The use of an arterial filter is
recommended.
5. Massive air entry into the PediMag Blood Pump
will cause the Blood Pump to deprime and blood
flow to stop. Clamp the outlet tubing and stop the
Blood Pump and remove air prior to resuming
circulation.
6. Do not expose the PediMag Blood Pump to
chemical agents as they may affect the integrity
of this device. Anesthesia solutions such as
forane are known to degrade polycarbonate
plastics.
7. To prevent backflow of the patient’s blood 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 limit
arterial pressure.
8. A Blood Pump stoppage will create a reverse
flow shunt through the Blood Pump, as well as
limit the body’s ability to maintain adequate
arterial pressure. If the Blood Pump is stopped,
clamp the outlet tubing from the Blood Pump to
prevent a low flow, low pressure, and reverse
flow condition. The tubing clamp must be
removed before returning to normal pumping
activity.
9. It is intended that systemic anticoagulation be
utilized while this device is in use.
Anticoagulation levels should be determined by
the physician based on risks and benefits to the
patient.
10. The PediMag Blood Pump is designed to be
operated only with the CentriMag drive Console.
There are no safety or performance data known
to Thoratec that establish compatibility of any
other manufacturer’s devices or components to
the PediMag Blood Pump.
11. Potential risk to the patient should be evaluated
prior to changing a PediMag Blood Pump.
12. Frequent patient and device monitoring is
recommended.
13. Do not use the PediMag Blood Pump if the “Use
Before” Date on the package has past or
expired.
14. Do not operate the PediMag Blood Pump in the
absence of forward flow. The temperature within
the Blood Pump will rise and increased cellular
damage and clotting may result.
15. The PediMag Blood Pump must be handled in
an aseptic manner until primed and connected to
a closed tubing circuit.
16. Do not operate the PediMag Blood Pump with its
inlet tubing clamped as a negative pressure will
be generated in the Blood Pump and air bubbles
may be formed in the priming fluid or blood.
17. Monitor the patient’s hemodynamics and the
Console Flow display to insure adequate blood
volume for the inlet cannula position, Blood
Pump RPM, and desired flow. Increase Blood
Pump RPM in small increments to minimize the
risk of exceeding the available blood volume and
causing inlet cannula obstruction, suction,
outgassing, and/or cavitation.
18. As with all continuous flow pumps, operating at
too high a speed can result in negative pressure
at the inlet which can lead to collapse of the
ventricle or blood vessels, inlet cannula
obstruction, inspiration of air, outgassing,
cavitation and increased risk of embolism.
Always operate the system at the lowest speed
consistent with the volume of blood available to
be pumped and clinically acceptable circulatory
support.
19. The PediMag Blood Pump contains a magnet.
To avoid injury, keep all sharp metal objects and
instruments at least six inches away for the
Blood Pump. Do not remove the PediMag Blood
Pump from its inner tray until ready to assemble
the circuit and insert pump into the motor
receptacle.
20. If PediMag Blood Pump operation is ever halted
or flow reduced, consideration should be given to
monitoring and adjustment of the patient’s
anticoagulation status.
21. Do not restart the PediMag Blood Pump if the
Blood Pump has been stopped for more than 5
minutes without adequate anticoagulation, as the
risk of thromboembolism is increased after blood
has remained stagnant in the Blood Pump,
extracorporeal circuit, and connectors.
22. Monitor the pump and tubing for air because the
PediMag Blood Pump, similar to other centrifugal
pumps, will pump air. Immediately clamp Pump
outlet tubing if air enters the PediMag Blood
Pump as gaseous emboli may be introduced into

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© 2013 Thoratec Switzerland GmbH – Document No PL-0112, Rev 04 (October 2013)
the patient, with attendant risk of death or severe
bodily injury. A massive air embolus will deprime
the Pump, halting blood flow.
23. Use of this Pump for periods longer than
durations appropriate to cardiopulmonary bypass
procedures may result in pump failure, reduced
pumping capacity, excessive blood trauma,
degradation of blood contact materials with
possibility of particles passing through the blood
circuit to the patient, leaks, and increased
potential for gaseous emboli.
CAUTIONS
1. Federal (U.S.A.) law restricts this device to sale,
distribution and use by or on the order of a
physician.
2. This device should only be used by persons
thoroughly trained in extracorporeal circulation
procedures.
3. Do not hit or strike the PediMag Blood Pump with
hands, objects, or instruments. Do not strike the
PediMag Blood Pump against any surface or
object. Shock may cause damage to the device,
which may cause device malfunction.
4. The PediMag Blood Pump is sterile in an
unopened and undamaged unit package. Inspect
device and package carefully prior to use. Do not
use if the unit package or the product has been
dropped, damaged or soiled.
5. Each PediMag Blood Pump is intended for single
use only. Do not resterilize. Resterilization by
any means may cause severe damage to the
device or its components. Dispose of safely after
single use to avoid risk of infection.
6. Attach tubing to the Blood Pump in such a
manner as to prevent kinks or restrictions that
may alter flow or cause regions of stasis or
turbulence. Attach in a manner that does not
bend or fracture the tubing connectors or ports.
Advance tubing beyond the second barb point of
the Blood Pump connectors.
7. The inlet and outlet tubing connections must be
secured with two small (approximately 10 cm
length) cable-ties or tie bands on each
connector. The locking mechanisms of the two
ties should be oriented 180 degrees from each
other to insure a tight seal of the tubing to the
connector.
8. Ensure the PediMag Blood Pump is properly
locked into the CentriMag Motor.
9. Monitor carefully for any signs of occlusion
throughout the circuit.
10. Do not operate the PediMag Blood Pump when
unprimed as it may damage the Blood Pump
impeller.
11. Run the PediMag Blood Pump only on a properly
maintained CentriMag drive Console and Motor.
12. Do not use the PediMag Blood Pump if it has
been dropped. Dropping or other severe shock
may cause damage which could lead to device
malfunction.
13. Do not use excessive force to install tubing on
the PediMag Blood Pump as damage to the
Blood Pump and 1/4” pump ports may occur.
14. Take care to prevent damage to PediMag Blood
Pump connectors when setting-up and de-airing
the Blood Pump.
15. Always have a spare PediMag Blood Pump,
Back-Up Console, motor, and accessories
available for change out.
16. Do not place PediMag Blood Pump near items
adversely affected by magnetic fields.
17. The PediMag Blood Pump has been qualified for
use with the Transonic H7XLF-series flow probe.
Do not use any other flow probe as their
performance has not been qualified for use with
the PediMag Blood Pump.
PRE-PUMPING CHECKLIST
1. Connect the CentriMag Motor to the CentriMag
Console.
2. Check that all electrical connections are secure
including flow probe and AC power cord.
3. Test the CentriMag Console by powering it up;
verify that there are no self-test errors on boot-
up.
4. Check the date and integrity of sterile PediMag
Blood Pump package.
5. Check that a Transonic H7XLF flow probe is
available for use with the CentriMag Primary
Console and is clean and ready for use.
CentriMag Back-Up Console does not have flow
measurement capability hence a flow probe is
not included with the Back-Up Console.
BLOOD PUMP SETUP AND OPERATION
The CentriMag System is designed to be operated
safely during use of ESU’s (electrosurgery or
electrocautery units). An ESU, a frequently used RF
technology, is used to cut, cauterize, fulgurate or
desiccate tissue. Note: ESUs have the potential for

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© 2013 Thoratec Switzerland GmbH – Document No PL-0112, Rev 04 (October 2013)
interfering with other medical devices found in the
operating and ICU room environment.
If the CentriMag Primary or Back-Up Consoles are
used concurrently with an Electrosurgery unit,
Thoratec recommends the user reads and follows
the electrocautery manufacturer’s instructions for
prevention of interference with other electronic
devices.
Follow the system preparation directions in the
Operating Manual for the CentriMag Primary
Console. Inspect the complete system; do not use a
malfunctioning or damaged system.
1. Determine the proper position for the Pump in
the extracorporeal circuit. During use, the Pump
fills by gravity from the reservoir and by the
gentle suction generated by the spinning
impeller. To reduce the potential for air embolism
from inadvertent emptying of the reservoir and
subsequent introduction of air into the Pump, the
Pump is typically positioned near and just below
the outlet of the reservoir from which the blood
will be pumped.
2. To mount the PediMag Blood Pump on the
CentriMag Motor, remove the Blood Pump from
the inner tray and insert the Blood Pump into the
motor receptacle. Place the bottom of the Blood
Pump into the motor receptacle with the outlet
port positioned in the large groove. Match the
grooves on the periphery of the Blood Pump with
the fittings on the motor receptacle. ROTATE
BLOOD PUMP COUNTERCLOCKWISE until
the Blood Pump locks securely into place.
Thread the retaining screw clockwise to secure
in place. The PediMag Blood Pump must be fully
seated into the receptacle to function properly.
Note: If the PediMag Blood Pump is not properly
seated an alarm “Pump Not Inserted” will be
displayed on the CentriMag Console display.
3. Assemble the extracorporeal circuit; be sure to
connect the inlet and outlet tubing to the correct
pump inlet and outlet. Connect 1/4 inch Inner
Diameter (ID) x minimum 3/32 inch wall tubing
from the reservoir outlet to the pump inlet. Attach
1/4 inch ID tubing to the pump outlet. Band all
connections.
4. Note: If a roller Pump is used for standby
equipment, leave sufficient tubing so that the
Blood Pump line can be placed in the roller
Pump.
5. To remove the PediMag Blood Pump from the
CentriMag Motor, unthread the retaining screw
counterclockwise, and then rotate the Blood
Pump clockwise until the grooves are matched.
Lift and remove the Blood Pump.
RECOMMENDED PUMPHEAD PRIMING
PROCEDURE
1. With accepted aseptic technique, attach the
appropriate tubing to the inlet and outlet of the
Pump. (Applying a sterile saline solution to the
inlet/outlet connectors may aid tubing
attachment.)
2. Where practical, flush the circuit and the Pump
with CO2 (from filter or reservoir bag.)
3. Fill the Pump with prime, by gravity, to a point
beyond the flow probe and clamp. Eliminate air
from the device by “walking” the air out of the
inlet.
CAUTION
Do not hit or strike the PediMag Blood
Pump with hands, objects, or
instruments. Do not strike the PediMag
Blood Pump against any surface or
object. Shock may cause damage to the
device, which may cause device
malfunction.
WARNING
Ensure that the Blood Pump and circuit
have been debubbled and primed
properly 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 the Blood Pump to deprime and
blood flow to stop. Clamp the outlet
tubing, stop the Blood Pump, and remove
air prior to resuming circulation.
6. Connect the Transonic H7XLF-series flow probe
to the outlet tubing according to the instructions
provided in the CentriMag Console Operating
Manual.
7. With the inlet tubing unclamped, and the outlet
tubing clamped, turn the CentriMag Console ON.
8. Remove all remaining tubing clamps, bring the
PediMag Blood Pump’s RPM up to a sufficient
speed to achieve a positive flow, inspect the
integrity of the Blood Pump, the tubing, and the
connections, if any anomalies are noted,
immediately stop the Blood Pump, clamp the
outlet tubing and correct the anomaly before
unclamping and restarting.

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© 2013 Thoratec Switzerland GmbH – Document No PL-0112, Rev 04 (October 2013)
WARNING
Do not operate the Blood Pump in the
absence of forward flow. The
temperature within the Blood Pump may
rise and increased cellular damage may
result.
WARNING
Do not operate the Blood Pump with the
inlet tubing or cannula clamped as a
negative pressure will be generated in
the Blood Pump and bubbles may form
in the Pump.
WARNING
If leaks or other anomalies are found on
the PediMag Blood Pump, remove the
Blood Pump and replace with a new,
sterile Blood Pump, repeating the above
steps to prime.
9. If no anomalies are noted, continue the priming
of your circuit in the usual fashion.
10. Verify all connections and the integrity and flow
of your circuit prior to use.
CAUTION
Placing a tubing clamp on the tubing
near a tubing connection point can
damage the connector, resulting in
thrombus formation at the area of the
damage.
11. Increase RPM to produce desired flow.
12. Set the Console’s low flow alarm to the desired
minimum flow point.
13. Secure the motor in order to maintain its location
in relation to the patient.
WARNING
As with any continuous flow pump,
operating at too high a speed can result
in negative pressure at the inlet which
can lead to inspiration of air, out
gassing, cavitation and increased risk of
embolism. Always operate the system at
the lowest speed consistent with the
volume of blood available to be
pumped.
CAUTION
Any time the PediMag Blood Pump is
stopped the pump outlet should be
clamped to prevent retrograde flow. The
clamp used should be a smooth jawed
tubing clamp.
PRE-BYPASS CHECKLIST
1. EQUIPMENT ASSEMBLY
a. Mount Motor correctly, relative to venous
reservoir.
b. Check that all electrical connections are
secure.
c. Check Console power and display.
d. Check the date and integrity of sterile Blood
Pump package.
e. Check that flow probe is sized properly.
f. Assemble perfusion circuit in sterile manner.
g. Allow sufficient tubing length for standby
pumping unit.
h. Connect flow probe to circuit in correct
location and flow direction.
2. PRIME, PUMP AND CIRCUIT
a. CO2flush Pump and circuit. If indicated, turn
OFF CO2.
b. Gravity-prime and debubble Pump and
perfusion circuit.
c. Check Pump for leaks, irregular motion, and
noise.
d. Check circuit for visible air.
e. Check that all tubing connections are secure.
f. Check Pump outlet line completely.
g. Clamp venous return line completely.
3. OPERATING PARAMETERS
a. Set low flow alarm.
b. Verify low flow alarm.
c.
4. EMERGENCY BACK-UP EQUIPMENT
a. A CentriMag back-up Console must be
plugged in with motor and flow probe
connected (if designed to accommodate a
flow probe), and kept near the patient ready
for use.
b. A sterile back-up PediMag Blood Pump
circuit and priming accessories must be
available.
c. Back-up power must be available.
d. Two smooth jawed tubing clamps must be
available.

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© 2013 Thoratec Switzerland GmbH – Document No PL-0112, Rev 04 (October 2013)
PERFUSION
a. Achieve minimum Pump speed prior to
unclamping lines.
b. Monitor Console for message and alarms.
c. Monitor perfusion circuit for visible air.
d. Maintain minimum Pump speed prior to
clamping lines.
DEVICE REMOVAL/DISPOSAL
Properly discard disposable components according
to hospital procedure for contaminated materials.
RETURNING HARDWARE TO STORAGE
a. Turn OFF power to the CentriMag Primary
and Back-Up Consoles.
b. Clean CentriMag Console and CentriMag
Motor according to established hospital
procedure.
c. Clean flow probe according to established
hospital procedure.
d. Reconnect CentriMag Consoles to AC power
to maintain charge on batteries.
EMERGENCY PUMP REPLACEMENT
If the PediMag Blood Pump has been OFF for more
than five minutes without adequate anticoagulation it
will be necessary to replace all of the disposable
components before support can be resumed. If there
has been a CentriMag Motor overheating condition, it
will be necessary to either terminate pumping OR
replace the Blood Pump and return circuit
components.
To replace the PediMag Blood Pump, disconnect the
Blood Pump from the CentriMag Motor and any
affected tubing. Attach the replacement Blood Pump
per the standard procedures described above, prime
and debubble. Operate the CentriMag Console as
described in the CentriMag Console Operating
Manual.
PRESSURE VS FLOW GRAPH
The PediMag Blood Pump output is pressure
responsive. In the graph below, the Pump flow rate
(L/min) versus the outlet pressure (mmHg) is plotted
at a variety of pump speeds using a blood analog
with a viscosity of 3.9 cp at 37°C. This graph does
not necessarily reflect the rates to be achieved under
clinical conditions.
Note: Actual obtainable flow is dependent on the
difference between the preload and afterload of the
Blood Pump (pump pressure differential).
BLOOD PUMP SPECIFICATIONS
Blood contact materials: Polycarbonate
Pump priming volume: 14 ml
Pump rotational range: 0-5,500 RPM
Outflow capacity: (see graph) 0-1.5 L/min
Outflow pressure:(see graph) 0-540 mmHg
Circuit tubing: 1/4 X 3/32 inch
STORAGE CONDITIONS
Temperature: 0 – 40°C (32 – 104°F)
OPERATING CONDITIONS
Temperature: 15 – 40°C (59 – 104°F)
PRODUCT RETURNS
Prior to returning any product, contact your Thoratec
Customer Service Representative for a return
authorization and instructions.
PediMag Blood Pump
H-Q Loop Performance (Blood Analog)
0
50
100
150
200
250
300
350
400
450
500
550
00.2 0.4 0.6 0.8 11.2 1.4 1.6 1.8 22.2 2.4 2.6 2.8 3
Flow (LPM)
Pressure (mmHg)
500 RPM
1000 RPM
1500 RPM
2000 RPM
2500 RPM
3000 RPM
3500 RPM
4000 RPM
4500 RPM
5000 RPM
5500 RPM
Source: PR-0145 Rev 00

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© 2013 Thoratec Switzerland GmbH – Document No PL-0112, Rev 04 (October 2013)
SYMBOLS ON THE PRODUCT PACKAGE
The following table describes the symbols used on
PediMag Blood Pump package:
Symbol Description
Catalog Number.
Lot Number.
Use By Date.
For single use only. Do not
reuse.
Sterilized with ethylene
oxide gas.
See Instructions for Use.
Federal (USA) law restricts this
device to sale, distribution and
use by or on the order of a
physician.
The contents of the
packaging are by means of
a validated method proven
to be PYROGEN free.
Symbol for manufacturer.
Symbol for temperature
limitation/temperature
range. Both upper and lower
limits are indicated adjacent
to horizontal lines.