CAPIOX Emergency Bypass System Instructions for Use Feb 2016

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 x6066 or [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

2019-XX

EBS™Circuit with X coating

TM

Instructions for Use

Please read this Instructions for Use carefully before use, and use this product according to the instructions described here.

Symbols on the packages of this product

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

Contents/Description of Product Contents 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

Description of Product 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.

Structure Structure

WARNINGS/PRECAUTIONS

Precautions for operation WARNINGS

・ 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.

・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/cm2). Pressure greater than 196kPa (2kgf/cm2) may cause leaks or damage to the device.

Precaution for storage PRECAUTION ・Pay attention not to wet the device. Avoid direct sunlight,

extreme temperature and humidity for storage.

Instructions for Use Thoroughly read “Warnings/Precautions” (Page 4 - 5) before use.

Instructions for 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. CAUTION

・Do not use if the unit package or the product has been damaged or soiled. ・When using CX*XSA0171, CX*XSA0173 or CX*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).

CAUTIONS

・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.

CAUTION

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).

CAUTION

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).

WARNING

Do not block the gas port (GAS OUT).

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

CAUTIONS

flow connector. ・When a flow connector is connected with a o flw 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.

CAUTION

• 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.

Priming procedure CAUTIONS ・This product should be primed with crystalloid solution

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 the priming line. ・At the same time, remove the clear priming solution from the sampling line to replace in the circuit. Figure 9

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.

Figure 10

Fill the tubing circuit except the centrifugal pump and the oxygenator with priming solution.

CAUTION

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.

Figure 11

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).

CAUTIONS

・After the rotation, lock the rotation, and make sure that the holder is fixed. ・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

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. CAUTION

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. CAUTION

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. CAUTION

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. CAUTIONS ・ 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

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. CAUTIONS

・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.

CAUTION

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

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). Figure 15

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

Figure 16

line (blue) respectively (Figure 18) (Figure 19). CAUTION

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. Figure 17

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.

CAUTION

The 3-way stopcock must be closed after completing removal of bubbles. Figure 18

6.

Fix the circuit to the patient or the bed.

CAUTION

Pay attention not to fold or kink the circuit. Figure 19

Initiation of BYPASS WARNINGS

・ 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).

WARNING

Do not operate the pump with the venous line (blue) clamped. Otherwise, negative pressure would be generated inside the pump and bubbles would be formed in 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).

CAUTION

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.

CAUTIONS

・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 WARNING

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

CAUTIONS

・ 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

WARNING

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.

b)

-

To decrease PaO2, decrease FiO2.

-

To increase PaO2, increase FiO2.

Control PaCO2 by changing the total gas flow.

CAUTION

-

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

• 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.

CAUTIONS

・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).