Directions for Use TandemLung Oxygenator CAT# 5160-0000

7000-0161 Rev.7 2018-08-23

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Figure 1. TandemLung Oxygenator

Page | 3 1. Overview The TandemLung Oxygenator is used in , in combination with a pump to oxygenate blood and remove carbon dioxide. The device consists of a hollow fiber membrane with blood inflow and outflow port and gas inlet and outlet port. Blood enters into the center of the fiber bundle where it is distributed radially and uniformly across the fiber bundle by a conical diffuser. The compact nature of the device, the orientation of the inflow/outflow ports, and optimized gap sizes on the inlet and outlet of the bundle simplify the priming process.

2. Indications for Use The TandemLung Oxygenator (TLO) is intended to be used for adult patients for extracorporeal circulation during in the field of open- surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.

3. Contraindications No contraindications are known provided the device is used within the Indications for Use and in accordance with the stated operating conditions.

4. Warnings and Precautions Only use the device in accordance with these Instructions for Use. • The oxygenator may only be used by persons trained in extracorporeal circulation procedures. • Possible side effects include infections, hemolysis, and embolisms. Side effects associated with extracorporeal circulation in general may also occur (e.g., post- perfusion syndrome and organ damage). • Observe the use-by date on the device packaging. • This disposable must not be reused or re-sterilized. Reused, reprocessed and re- sterilized devices could be contaminated, unsuitably packaged or unsuitably labeled. • The material properties, function and sterility of the device may be compromised by incorrect storage, incorrect use of the device, or use after the use-by date resulting in failure or malfunction of the device and damage to health, or even death, of the patient, user or third parties. • Do not use the device if it or the sterile packaging is damaged. • Always observe strict aseptic technique when handling the device. • Do not submerge the oxygenator. Liquids should never be introduced into the gas pathways. • The oxygenator with fiber membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules are unable to pass through the diffusion membrane. • Observe the permissible maximum values for blood pressure and flow (see the “Specifications” section. • The gas outlet vents or port must not be closed or blocked. Otherwise the gas flow may be constrained or a gas overpressure situation may occur. • The oxygenator and the associated system must be completely de-aired before beginning extracorporeal circulation. During the de-airing process, the oxygenator must not be tapped with hard objects (such as tubing clamps). • Suitable anticoagulation is required and must be monitored during use of the oxygenator. • The advantages of extracorporeal circulation need to be weighed against the risks associated with systemic anticoagulation. • Arterial connections must not be used to administer medication. • For arterial blood gas analysis, use a sampling port in the arterial tube. The actual composition of the arterial blood gases can only be determined at the arterial outlet.

Page | 4 • TandemLife recommends the use of an oxygen-air blender (gas blender) for gas control during extracorporeal circulation. • During circulation, forward flow and positive pressure must always be maintained on the blood side. • Positioning the device above the level of the patient’s heart may result in air being entrained into the device. • Gas flow to the TandemLung should be discontinued when the circulation is stopped or recirculated. During periods off the system, the blood gases should be checked. Excessive gas flow may cause hyperoxia, hypocarbia, alkalosis and/or blood trauma. • Monitor the pressure drop across the oxygenator to ensure no restriction in the device develop. If necessary, change the oxygenator. • If a leak occurs, the use of TandemLung should be discontinued or the device should be changed. • Do not allow solvents such as alcohol, ether, acetone, or liquid inhalation anesthetics (e.g. isoflurane, Ethrane (enflurane)) to come into contact with the outside or inside of the oxygenator, as they may cause damage. • Pinching off the arterial outlet side is not permitted while the heart- machine is running, since this creates a brief increase in flow when the clamp is removed. This can lead to negative pressure on the blood side, which may allow gas to penetrate the membrane. • If blood cardioplegia is used, ensure that the flow of the arterial pump is always higher than the flow of the cardioplegia pump. • To prevent gas or particle embolisms, safety devices such as pre-bypass filters, arterial filters, level sensors and bubble detectors for all cardiopulmonary bypass interventions may be used. • If injectable anesthetics such as Propofol are used, they should not be administered immediately upstream of the oxygenator. Furthermore, only small bolus rates or volumes per unit of time should be used because large drug boluses may create fat deposits that impair the function of the oxygenator. • When using the oxygenator, methylene blue must not be administered directly before or during perfusion. • Dispose of the device according to applicable regulations for contaminated devices.

For any questions, contact TandemLife at 800-373-7421.

5. Packaging and Storage The device is delivered sterile and pyrogen-free. Sterility remains assured as long as the packaging is not opened or damaged and the use-by date has not expired. The device must be stored in a cool, dark and dry place until used. Prescribed storage temperature: +10 °C … +30 °C (+50 °F … +86 °F)

Biological testing (including pyrogen and bioburden testing) has been performed to assess acceptable limits of biological contaminants.

Shelf life validation (including package integrity/distribution testing, accelerated aging, and microbial challenge testing) has been performed and real time follow-up will be performed to determine that the device and package will maintain their integrity for the period of time specified on the package label.

Page | 5 6. Specifications

Blood Flow 1.0 – 5.0 l/m 2 Oxygenation Membrane Surface Area 1.8m Priming Volume < 200 ml Sterilization Method Ethylene oxide Permissible Maximum Values Blood side pressure max. 500 mmHg Recommended Gas Flowrate max. 15.0 l/min. Connectors Blood Inlet and Outlet 3/8” Gas Inlet 1/4” Materials Housing Polycarbonate Oxygenation fibers Polymethylpentene (PMP) Gas Caps Polycarbonate Potting Material Polyurethane Sterile Pouch Polyethylene, Tyvek

6.1 Symbols on Packaging:

Read Directions For Use before using this device Manufacturing date

Single use only Sterilized by Ethylene Oxide gas

PYROGEN Non-pyrogenic

SN Serial number

Use by

REF Catalog number

Recommended Storage Temperature Conditions

Do not re-sterilize

Federal law (U.S.A.) restricts this device to Rx Only sale by or on the order of a physician.

Do Not Use if Package is Damaged

Page | 6 7. Application

7.1 Setup 1. Place the 3/8” tubing onto the port labeled “Blood Outlet”. 2. Place the 3/8” Barb Connector with Luer into the 3/8” tubing. 3. Place the other 3/8” tubing onto the 3/8” Barb Connector with Luer 4. Prime the TandemHeart Pump lower chamber as described in the TandemHeart Pump Directions for Use. 5. Connect the Red Striped tubing from the Pump onto the Oxygenator port labeled “Blood Inlet”. NOTE: If pressure monitoring across the oxygenator is desired, a 3/8” Barb Connector with Luer can be added to the pump outflow tubing (red stripe) approximately 3” from the pump.

7.2 Priming the System

With 60cc Fluid Filled Syringe 1. Hold the free ends of the tubing in such a way that they are the highest point. 2. Slowly infuse saline into the open end ensuring not to create microbubbles. 3. Allow saline to fill the pump and oxygenator and flush the air out the end of the tubing. Approximately 240cc of saline (four 60 cc syringes) will be needed to prime the circuit. NOTE: DO NOT SUBMERGE THE OXYGENATOR. Liquid should never be introduced into the gas pathways. 4. Tap the oxygenator and pump to expel all air from the circuit. The tubing may also be connected to a reservoir and saline pumped through the circuit at 1-3 LPM to remove any additional air. 5. When all air has been successfully removed and the circuit has been fully primed, clamp the pump inflow and oxygenator outflow tubing approximately 1” from the end of the tubing. 6. Ensure that the entire system is fully de-aired before beginning extracorporeal circulation. 7. Attach the gas line (green tubing) to the GAS IN port on the oxygenator.

With Fluid Filled Basin 1. Place the pump inflow tubing (blue stripe) into a sterile basin filled with saline. NOTE: DO NOT SUBMERGE THE OXYGENATOR. Liquid should never be introduced into the gas pathways. 2. Place the oxygenator outflow tubing (red stripe) into a sterile basin filled with saline – crisscross tubing outflow (red) over inflow(blue). This will eliminate air being inadvertently sucked into the circuit. Ensure that the oxygenator outlet port is pointed upward to 12:00. 3. Select “Start the pump” on the Escort controller NOTE: Ensure that both pump inflow tubing (blue stripe) and oxygenator tubing (red stripe) remain submerged in the basin 4. Tap the oxygenator and pump to expel all air from the circuit. 5. When all air has been successfully removed and the circuit has been fully primed, stop the pump on the Escort controller, clamp the pump inflow and oxygenator outflow tubing approximately 1” from the end of the tubing. 6. Ensure that the entire system is fully de-aired before beginning extracorporeal circulation.

7.3 Attaching the Gas Line 1. Attach the section of sterile gas line (green tubing) packaged with the oxygenator to the GAS IN port on oxygenator. 2. Attach the bacteriologic filter (packaged separately) to free end of the gas line. Page | 7 3. Attach the additional section of the gas line (green tubing packaged separately) to free end of the bacteriologic filter. 4. Attach free end of the separately packaged gas line to the gas source. 5. Verify all connections are secure.

7.4 Extracorporeal Circulation 1. Start the gas flow with 100% oxygen and gas-to- blood flow at a 1:1ratio. 2. Start extracorporeal circulation. Ensure that there is always sufficient venous backflow to the reservoir. 3. Check the setting of the gas flow values and adjust the oxygen content and the gas-to-blood flow ratio according to the readings. e.t. by means of a blood gas analysis

Check the effect of anticoagulants (e.g. ) at regular intervals by measuring the Activated Clotting Time (ACT). The ACT should not fall below 450 sec. If the extracorporeal bypass is temporarily interrupted, recirculation should be maintained at a minimum flow of 200-250 ml.

7.5 Changing Oxygenators During extracorporeal circulation the oxygenator should only be exchanged in the event of a malfunction resulting in inadequate patient support. In the case of a malfunction proceed as follows: 1. Always use aseptic technique when exchanging the oxygenator. 2. Maintain circulation with the first oxygenator until the replacement oxygenator is ready for use. 3. Have the following items ready: o 4 additional tube clamps o Sterile scissors o Disinfectant/Antiseptic (Important: do not allow contact with the oxygenator housing) o 1 replacement oxygenator primed according to Section 7.1 Setup Steps 1-3.

Procedure 1. Apply Disinfectant/Antiseptic to a section of tube at both the upstream and downstream sides of the oxygenator. 2. Spray a section of tube at the upstream and downstream sides of the oxygenator with disinfectant. 3. Stop the pump and immediately apply 2 clamps to each tube at the upstream and downstream sides of the oxygenator. The closest clamp on each side should be at a distance of 3-5 cm from the oxygenator and the second clamp 5-10 cm from the closest clamp. 4. Connect the gas line to the gas inlet connector of the replacement oxygenator. Cut through the venous and arterial tube lines using the sterile scissors, and remove the defective oxygenator. Cut between the two clamps, but closer to the more proximal clamp in order to leave adequate tubing to connect the new oxygenator. 5. Connect the new oxygenator using a wet-to-wet connection with the two open tubes using 3/8” Barb Connectors. 6. Ensure no air is in the circuit. 7. Remove the tubing clamps. 8. Turn on the Pump to the desired speed to achieve the desired flowrate. 9. As soon as possible, check the gas: blood ratio setting and the oxygen content in the gas supply, e.t. by means of a blood gas analysis.

7.6 Emptying the oxygenator Page | 8 Various methods can be used for emptying the TandemLung Oxygenator • An empty blood bag is connected to the arterial outlet and the blood drains by gravity out of the oxygenator and tube system. For this, the tubing segment must be removed from the roller pump. • To speed the emptying process, the blood can also be actively pumped out of the system and the oxygenator using the pump.

Performance Data

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Page | 11 Customer Service Product Returns: Prior to returning any product to TandemLife, contact a Customer Service representative (at 800-373-7421) for a return authorization number and instructions. Technical Support: If a TandemLung Oxygenator fails to operate in accordance with specifications during operation, call TandemLife Clinical/Technical Support at: 1-800-373- 1607 in the US or 1-412-579-6182 internationally.

TandemLung is a registered trademark of CardiacAssist, Inc. Manufactured by: CardiacAssist, Inc., Pittsburgh, PA, U.S.A.

CardiacAssist, Inc. dba TandemLife 620 Alpha Drive | Pittsburgh, PA 15238 | 412.963.7770 phone | 412.963.0800 fax