Terumo CAPIOX EBS Circuit with X coating User manual

CAPIOX®
Emergency Bypass System
Instructions for use

Indications for Use
The CAPIOX Emergency Bypass System (EBS) is authorized to be used by healthcare
providers (HCP) in the hospital setting for providing long-term (> 6 hours) respiratory
or cardiopulmonary support to treat patients 18 years or older with Coronavirus
Disease 2019 (COVID-19) who have acute respiratory failure or acute
cardiopulmonary failure, where other available treatment options have failed, and
continued clinical deterioration is expected or the risk of death is imminent.
Contraindications
Known heparin sensitivity
Inferior vena cava filter
2 

Disclaimers
The CAPIOX EBS has neither been cleared or approved for providing long-term
(> 6 hours) respiratory or cardiopulmonary support to treat patients 18 years or
older with Coronavirus Disease 2019 (COVID-19) who have acute respiratory
failure or acute cardiopulmonary failure, where other available treatment options
have failed, and continued clinical deterioration is expected or the risk of death
is imminent; and,
The CAPIOX EBS has been authorized for the above emergency use by FDA
under an EUA; and,
The CAPIOX EBS has been authorized only for the duration of the declaration
that circumstances exist justifying the authorization of the emergency use of
medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the authorization is terminated or revoked sooner.
Contact Information
Product Surveillance can be reached at 800-521-2818 x6066or
[email protected]
Customer Service can be reached at 800-521-2818 x6929 or
[email protected]
Tech Support can be reached at 800-521-2818 x6932 or
[email protected]
3 

CAPIOX®
EBS™Circuit with X coating™
Instructions for use

EBS
™
Circuit with X coating
TM
Instructions for Use
2019-XX
Please read this Instructions for Use carefully before use, and use this product according to the
instructions described here.

Symbols Instructions
Catalogue number
Batch code
Use-by date
Manufacturer
Consult instructions for use
Do not re-use
Do not resterilize
Sterilized using ethylene oxide
Keep away from sunlight
Keep dry
Fragile, handle with care
Do not use if package is damaged
Temperature limit
This way up
Non-pyrogenic
Symbols on the packages of this product

Contents
Description of Product
Contents/Description of Product
Contents 3
Description of Product 3
Structure 4
Warnings/Precautions
Precautions for operation 5 - 6
Precaution for storage 6
Instructions for Use
Set up 7 - 9
Priming procedure 10 - 12
Connection 13
Initiation of BYPASS 14
During perfusion 14 - 16
Termination of BYPASS 16
Circuit replacement 17
Data 18
Specifications 19
Limited warranty 20
This Product is a kit consisting of membrane oxygenator with
microporous polymethylpentene hollow fibers, a centrifugal
pump to send blood, and blood tubing. It is intended for use
during extracorporeal circulation for cardiovascular surgery and
ECLS (Extracorporeal Life Support). Blood and gas flow on the
outside and inside of fiber respectively in the membrane
oxygenator. Straight path design employed in the centrifugal
pump reduces disorder in blood flow and minimizes blood
component damage.
The blood contacting surfaces are coated with Xcoating.
This product is used with CAPIOX SP Pump Console SP-101 or
CAPIOX Centrifugal Pump Controller SP-200 as a driving
instrument of the centrifugal pump.
Contents/Description of Product

Structure
Structure

Precautions for operation
・ Adequate heparinization of the blood is required to
prevent blood coagulation in the system.
・Never clamp the venous line (blue) during circulation.
Otherwise, pressure inside of the pump will turn into
negative, which is a potential hazard of producing gas
bubbles.
・Always close the branch line of the venous line (blue)
during circulation. Otherwise, pressure in this part will turn
into negative, which is a potential hazard of intermixing
bubbles.
・DO NOT OBSTRUCT GAS OUTLET PORT.
Avoid build-up of excess pressure in the gas phase to
prevent gaseous emboli entering the blood phase.
・The oxygenator must be positioned lower than the patient.
Pressure in the blood phase should always be higher than
that in the gas phase to prevent gaseous emboli entering
the blood phase.
・The gas flow should not exceed 20L/min. Excessive gas
flow will bring about pressure increase in the gas phase,
allowing gaseous emboli to enter the blood phase.
・ Do not exceed a 15
°
C (27
°
F) temperature difference
between blood and water in heat exchanger to prevent gas
dissolved in blood from forming bubbles.
・This product should be used under monitoring. If
abnormalities such as product-damage and deteriorated
performance are observed, replace the product with a new
one properly after ascertaining the state of patient.
There are possibilities that increasing blood cell damage or
blood coagulation is formed, or the circulation is
obstructed.
PRECAUTIONS・This product should be used by a physician or under the
supervision and/or direction of a physician.
・This product is sterilized by ethylene oxide gas.
・For single use only. Do not reuse. Do not resterilize. Do not
reprocess. Reprocessing may compromise the sterility,
biocompatibility and functional integrity of the device.
WARNINGS/PRECAUTIONS
WARNINGS

Precaution for stora
g
e
・Do not use if the unit package or the product has been
damaged or soiled. Use it immediately after opening the
unit package and dispose of it safely after use.
・Spare pack of CAPIOX EBS Circuit should be available for
emergency exchange.
・Do not allow solvents such as alcohol, ether, acetone, etc.
to come in contact with the device as it may cause
damage to the device.
・ Use CAPIOX SP Pump Console SP-101 and CAPIOX
Centrifugal Pump Controller SP-200 according to the
instructions described in the Instructions for Use.
・Set this product correctly with a holder or a drive motor.
・The centrifugal pump of this product contains a magnet.
Therefore, keep away from metals and magnetic tapes.
・ Use this product at flow rate lower than the maximum 7
L/min.
・Do not exceed the maximum pump speed of 3000rpm.
Otherwise, it would increase blood damage and cause
breakage of this product and leakage.
・ Do not install or remove the pump until the motor has
completely stopped.
・All procedures must be aseptically performed.
・Perform priming procedure using crystalloid solution which
contains no blood, plasma and/or blood derived products.
・For monitoring temperature, Y.S.I. 400 Series manufactured
by Measurement Specialties Inc. can be used. Use it with
its exclusive cable.
• In case of using CAPIOX EBS Cannula Kit, follow
instructions described in the Instructions for Use.
・ Water pressure at the heat exchanger inlet should
notexceed 196kPa (2kgf/cm
2
). Pressure greater than
196kPa
(2kgf/cm2) may cause leaks or damage to the device.
・ Pay attention not to wet the device. Avoid direct sunlight,
extreme temperature and humidity for storage.
PRECAUTION

Instructions for use
Thoroughly read “Warnings/Precautions” (Page 4 - 5) before use.
Set Up
1. Set a holder and a drive motor.
・ Fix the drive motor to the holder tightly with screws for
thedrive motor (Figure 1).
2. Fix the holder to the pole with a pole clamp of the holder
(Figure 2).
3. Take the product out of the unit package and confirm there is
nothing wrong.
・ Do not use if the unit package or the product has
been damaged or soiled.
・ When using CX
*
XSA0171, CX
*
XSA0173
orCX
*
XSA0251, do not hold the product by
the tube between oxygenator and centrifugal
pump.
This may cause heavy load at the
connection
parts of tubing and lead to leakage.
4. Confirm that all the screws of 3-way stopcocks, caps and
connectors are fixed tightly, and that the clamps of the arterial
line (red), the venous line (blue) and the priming line are
open.
5. Set the centrifugal pump to the drive motor fixed to the holder.
(For CX*XSA: Remove the cover of the centrifugal pump.)
①Remove the magnet cover from the drive motor (Figure 3).
②Insert the rim of the centrifugal pump into the fixed hook of
the drive motor (Figure 4).
③Insert the rim of back side of the oxygenator into the fixed
hook of the holder (XX*EB04), and push forward and set the
oxygenator (Figure 5).
Instructions for Use
CAUTION

・ Make sure that the underside of the centrifugal
pump is in close contact with the pump receptacle
and that the slide hook is in position (Figure 6).
・ Make sure that the rim of back side of the
oxygenator and the hook of the exclusive holder
are connected to the slide hook (Figure 7).
・ Only when the display of the motor rpm indication
shows “0”, the centrifugal pump can be attached or
detached .
6. Connect the water lines (inner diameter of the tube;
12.7mm (1/2”) or couplers) to the water ports of CAPIOX
EBS circuit (Figure 8-a, 8-b).
7. Start water circulation through heat exchanger and circulate
for at least 5 minutes. Check for leaks.
Do not use an oxygenator that leaks. Replace it with
another EBS circuit.
8. Connect the thermistor probe and the temperature monitor
cable (Figure 8-c).
For a monitor, Y.S.I. 400 Series manufactured by
Measurement Specialties Inc. can be used. Use it
with its exclusive cable.
9. Connect the gas line (inner diameter of the tube; 6.4mm (1/4”))
to the gas port (GAS IN) (Figure 8-d).
Do not block the gas port (GAS OUT).
WARNING
CAUTION
CAUTION
CAUTIONS

10. After the circuit was assembled, confirm all parts are
connected properly, and the tubes are not folded or kinked.
11. When using with CAPIOX SP Console SP-101:
Attach the CAPIOX SP Pump Flow Sensor 3/8” to the flow
connector on the arterial line following the Instructions for Use
of CAPIOX SP Pump Console SP-101.
・ Ultrasonic sensor gel must be fully applied to the
flow connector.
・ When a flow connector is connected with a flow
sensor, attach recommended ultrasonic gel
(AQUASONIC 100 made by Parker) adequately
between the flow sensor and flow connector. Do
not use gel which solvents are included such as
alcohol, thinner and amine, etc. These solvents
may cause damage the sensor and connector.
12. When using with CAPIOX Centrifugal Pump Controller
SP-200:
Attach the ABD/Flow Sensor to 3/8” tubing, following the
Instruction for Use of CAPIOX Centrifugal Pump Controller
SP-200.
• When attaching the ABD/Flow Sensor, apply
enough vaseline to evenly coat the detection
window of the clamp-on ABD/Flow sensor. If the
amount of vaseline applied is insufficient, the Flow
Signal Unstable Alarm may be issued, and air
bubbles may not be detected.
13. After the circuit was assembled, confirm all parts are
connected properly, and the tubes are not folded or kinked.
CAUTION
CAUTIONS

Priming procedure
・ Thisproductshouldbeprimedwithcrystalloidsolution
which contains no blood, plasma and/or blood
derived products.
・ In case of adding blood or plasma, etc. in the priming
solution, after priming, follow the procedure below.
・ Infuse blood or plasma, etc. from thepriming line.
・ Atthesametime,removetheclearprimingsolution
from the sampling line to replace in the circuit.
1. Set the circuit at the lower position than the oxygenator.
2. Remove the protection cap from the plastic spike after closing
the clamp on the priming line. Then connect the plastic spike to a
bag or a bottle filled with priming solution.
3. After confirming that the 3-way stopcock on the priming line is
open, release the clamp.
4. Fill the tubing circuit except the centrifugal pump and the
oxygenator with priming solution.
It may take more time for priming if a large quantity of
bubbles remains in the circuit.
5. Fill the oxygenator and the centrifugal pump with priming
solution.
6. After the circuit is fully primed or almost fully primed, pull out the
handle of the exclusive holder (XX
*EB04) (Figure 9).
7. Unlock the rotation of the exclusive holder (XX
*
EB04) (Figure 10)
and rotate the whole holder 90 degrees (Figure 11).
Figure 9
Figure 10
Figure 11
・ Aftertherotation,locktherotation,andmakesure
that the holder isfixed.
・When rotating 90 degrees, the tube must be put on
the holder for rotation not to fold the circuit
(Figure 12).
・Pay attention to prevent the tubing from tucking in
during rotation.
Figure 12
CAUTIONS
CAUTION
CAUTIONS

8. Press the Auto-Priming button or the icon of the applicable
centrifugal pump controller.
The Auto-Priming function works on the centrifugal pump to
turn intermittently.
The procedure to expel bubbles in the circuit through
microporous of the oxygenator is automatically performed.
Do not operate the centrifugal pump without filling
it with priming solution. Otherwise, the centrifugal
pump may get damaged.
9. Confirm that bubbles in the circuit are completely removed
while the centrifugal pump turns intermittently. At this time,
remove the cap (with air filter) of the sampling port on the
sampling line of the oxygenator and open the 3-way stopcock,
and then remove bubbles from the sampling line using a
syringe.
When bubbles remain at the junction parts of
connectors etc., remove them by tapping the parts.
10. Hold the handle for rotation of the exclusive holder (XX*EB04)
and unlock the rotation. Then rotate the holder 90 degrees and
replace it at the previous position (Figure 13). Put away the
handle for rotation depending on the situation.
After the rotation, lock the rotation, and make sure
that the holder is fixed.
11. Press the Auto-Priming button or the icon again to compete
auto priming.
12. Confirm that the motor rpm adjustment knob of the centrifugal
pump console is at the position of “0”.
13. With the pump outlet clamped, set the pump speed to
3000rpm (maximum speed) for approximately 30 seconds.
Since this condition makes internal pressure of the centrifugal
pump maximum, check it for something wrong such as
leakage from EBS circuit.
・ Do not operate the centrifugal pump for a long
time with its outlet clamped, which will raise the
temperature of the priming solution.
・Do not use when something wrong is noted and
replace the EBS circuit with a new one.
Figure 13
CAUTIONS
CAUTION
CAUTION
CAUTION

14. Turn the motor rpm adjustment knob to “0” and stop the
rotation of the pump.
15. Pulling up the slide hook of the drive motor, remove the
centrifugal pump from the drive motor (Figure 14).
After confirming that the centrifugal pump has been thoroughly
primed and there is nothing wrong with it, set the pump to the
drive motor again.
・Only when the display of the motor rpm indication
shows “0”, the centrifugal pump can be attached
or detached.
・ In case that the bubbles still remain in the
centrifugal pump, set the centrifugal pump to the
drive motor again, and remove them circulating
priming solution.
・After the bubbles were completely removed from
the circuit, until the extracorporeal circulation
starts, stop the centrifugal pump with its pump
speed "0". Do not continue circulation
excessively.
16. Close the clamp and the 3-way stopcock on the priming line.
If circulation starts without closing the clamp and the
3-way stopcock, air will enter the circuit. Therefore,
be sure to close them.
Figure 14
CAUTION
CAUTIONS

Connection
1. Close clamps of the arterial line (red) and venous line (blue)
from over the clean cover (Figure 15).
2. Remove the clean cover pulling from the corner (Figure 16).
3. Loosen each screw wing for the arterial line and the venous
line to remove the bypass connector (Figure 17).
4. Connect the inserted arterial cannula (red) to the arterial line
(red) and the inserted venous cannula (blue) to the venous
line (blue) respectively (Figure 18) (Figure 19).
When the arterial and venous cannulas are connected
to corresponding lines, prevent them from kinking.
Otherwise, flow rate will not be secured, and it may
lead to damage of cannulas.
5. Take off the cap (with air filter) from the 3-way stopcock for
removing bubbles, and remove bubbles remaining in the circuit
using a syringe.
The 3-way stopcock must be closed after
completing removal of bubbles.
6. Fix the circuit to the patient or the bed.
Pay attention not to fold or kink the circuit.
Figure 15
Figure 16
Figure 17
Figure 18
Figure 19
CAUTION
CAUTION
CAUTION

Initiation of BYPASS
・ Prior to starting circulation, confirm that priming line is
closed as well as 3-way stopcocks for removing bubbles
and those of the sampling port. If the 3-way stopcocks
are not closed, bubbles may enter the circuit as the
pressure inside the venous line (blue) is negative during
circulation.
・Prior to delivering gas, confirm that the gas port
(GAS OUT) is not blocked up. Otherwise, the pressure of
the gas side in the oxygenator will increase, and bubbles
will flow into the blood side.
・Make sure that the underside of the centrifugal pump is in
close contact with the pump receptacle and that the slide
hook is in position.
1. Open the clamp of the venous line (blue) and forceps on the tube of the
venous cannula (blue).
Do not operate the pump with the venous line (blue)
clamped. Otherwise, negative pressure would be
generated inside the pump and bubbles would be formedin
the blood.
2. Start the rotation of the centrifugal pump and set the pump speed at
around 1000rpm.
3. Gradually release the clamp on the arterial line (red) to start circulation
(Figure 20).
After-load pressure higher than the pump's outlet pressure
causes back flow of the blood. To prevent this, do not
unclamp the outlet of the pump at the start of circulation, until
an adequate outlet pressure has been reached. (Refer to the
data on Pump performance (19 page).)
4. Start gas supply.
・Start gas supply only after blood circulation is initiated.
・Start gas supply with V/Q = 1 and FiO2 = 100%.
5. Adjust the pump speed of the centrifugal pump console for appropriate
flow rate.
During perfusion
Never clamp the venous line (blue) during circulation.
Otherwise, negative pressure would be generated inside
the pump and bubbles would be formed in the blood.
Figure 20
WARNING
CAUTIONS
CAUTION
WARNING
WARNINGS

・ Carefully adjust the pump speed to control the
blood flow, because the blood flow varies
depending on the load applied to the pump (the
patient's arterial pressure, resistance of the circuit).
・ Control blood flow by adjusting the pump speed.
Partially clamping the outlet of the pump to control
the blood flow may increase the blood damage.
・Entry of massive air into the pump will cause the
pump to deprime and the blood flow to stop.
When resuming circulation, stop the pump
once and remove the air.
・ After-load pressure higher than the pump's outlet
pressure causes back flow. When decreasing
the pump speed, adjust the pump speed
taking care not to cause back flow.
1. Collect blood from the sampling line of the oxygenator
(Figure 21).
Never collect blood from branch lines of the arterial
line (red) and the venous line (blue). Otherwise,
bubbles may enter the circuit.
2. Measure blood gases and make necessary adjustments as
follows:
a) Control PaO2 by changing concentration of oxygen in
ventilating gas using gas blender.
- To decrease PaO2, decrease FiO2.
- To increase PaO2, increase FiO2.
b) Control PaCO2 by changing the total gas flow.
- To decrease PaCO2, increase total gas flow.
- To increase PaCO2, decrease total gas flow.
• A minimum of 0.5L/min oxygen gas flow is needed
when blood is circulated. Less than 0.5L/min oxygen
gas flow may result in inadequate gas exchange.
Figure 21
CAUTION
WARNING
CAUTIONS

• During circulation, always carefully monitor the patient
blood condition and the oxygenator gas exchange
performance. If gas exchange performance
deteriorates, temporarily raise the gas flow rate to
flush the inside of the fiber and try to recover
performance.
The gas flow rate for flushing is 20 L / min, the time is
10 seconds. If the performance does not recover
immediately, it is considered to be caused by plasma
leak. Therefore, replace this product with a new one
without repeating the flush. A phenomenon called
wet lung may occur when water condensation occurs
inside fibers of microporous membrane oxygenators
with blood flowing exterior to the fibers. This may
occur when oxygenators are used for a longer period
of time.
Termination of BYPASS
1. At the termination of circulation, clamp the arterial line (red) by
forceps etc. taking care that no back flow occurs. After that, stop
the pump by adjusting pump speed to 0.
2. Immediately after stopping the pump, stop gas supply.
・Do not supply gas while the circulation stops. When
gas is supplied in case of recirculation, check blood
gas pressure.
Excessive gas supply may cause low PaCO2,
alkalosis and blood damage.
・ When stopping circulation, be sure to clamp the
outlet of the pump and then stop the motor. Do not
clamp the venous line (blue) first.
・Do not operate the pump for a long time with its
outlet clamped. The temperature within the
pump may rise and increase blood damage.
・ After-load pressure higher than the pump's outlet
pressure causes back flow. While circulation is
terminated, clamp both the arterial line (red)
and the venous line (blue).
CAUTIONS