Breethe OXY-1 System Instructions for Use and Reference Manual Rev M Oct 2020

USER RESPONSIBILITY The OXY-1 System will perform in conformity with the description thereof contained in this manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. The OXY-1 System must be checked and serviced periodically. A defective system should not be used. Parts that are broken, missing, plainly worn, distorted, or contaminated should be replaced immediately. Should such repair or replacement become necessary, Breethe recommends that a telephone or written request for service advice be made to your sales rep or directly to Breethe’s service line. The OXY-1 System or any of its parts should not be repaired other than in accordance with written instructions provided by Abiomed and performed by Abiomed authorized service personnel. The OXY-1 System must not be altered without Abiomed's prior written approval. The operator of the OXY-1 System shall have the sole responsibility for any malfunction that results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than Abiomed. © 2020 Breethe, Inc. All Rights Reserved

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ABOUT THIS MANUAL INSTRUCTIONS FOR USE Read the entire operating manual completely before use. This manual contains special notifications: WARNING! This instruction must be observed to avoid injury to the patient, operator or other persons. CAUTION! This instruction must be observed to avoid damage to the equipment. NOTE Additional detail for explanation. INDICATIONS & INTENDED USERS INDICATIONS FOR USE The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration. INTENDED USERS The OXY-1 System must be operated and/or monitored by users with specialized training in extracorporeal circulation therapy. These users include perfusionists, extracorporeal circulation specialists, ICU nurses with specialized extracorporeal circulation training, cardiothoracic surgeons, intensivists, and others with specialized training and experience. Users are required to be knowledgeable and experienced in methods that require cardiopulmonary bypass and mechanical circulatory support. Utilization of the Breethe OXY-1 System requires clinical judgement for patient risks vs benefits in all circumstances and requires specialized training in the use of cardiopulmonary bypass systems for safe operation under the direct supervision of a qualified physician. This is a prescription-only device. CONTRAINDICATIONS This device used for any other purposes than for the indicated intended use is the responsibility of the user.

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SYMBOLS Read Manual Read Instructions Quantity Class II IEC Mass Input Prescription Only Type CF Use By Reserve Port 1 Oxygen Gas Cable Interface 1 MET Certification Mark Warning OXY-1 System Operator’s Manual

On Standby On/Standby Switch Manufacturer Date of Manufacture Unique Device Identifier Catalog Number Lot Number Serial Number Reserve Port 2 Tubing Interface 1 Fuse Do Not Reuse Caution

Keep Dry Storage Humidity Range Keep Away from Sunlight Non-Pyrogenic Storage Temperature Range Do Not Use if Package is Damaged Recycle: Electronic Equipment Water Ingress Rating Sterilized Using Ethylene Oxide Data Transfer Tubing Interface 2 Pole Mount Bracket Orientation Lithium ion batteries contained in equipment Package Orientation during Shipping 5

TABLE OF CONTENTS

USER RESPONSIBILITY................................................................................. 3 ABOUT THIS MANUAL.................................................................................... 4 Instructions for Use....................................................................................... 4 Indications & Intended Users........................................................................ 4 Contraindications.......................................................................................... 4 SYMBOLS......................................................................................................... 5 WARNINGS & CAUTIONS............................................................................... 7 TECHNICAL SPECIFICATIONS ...................................................................... 10 GLOSSARY OF TERMS................................................................................... 12 1. OXY-1 SYSTEM DESCRIPTION................................................................... 14 1.1 Theory of Operation................................................................................ 17 1.2 Special Functions.................................................................................... 19 2. OXY-1 SYSTEM OPERATING INSTRUCTIONS ........................................ 20 2.1 Adjusting Parameters ............................................................................. 20 2.2 Display Icons & Description ................................................................... 24 2.3 Installing PLU Disposable into Pump Driver.......................................... 26 3. ALARMS & TROUBLESHOOTING.............................................................. 27 3.1 Alarm Definitions, Conditions and Actions............................................. 27 3.2 Alarm Troubleshooting .......................................................................... 29 4. OPERATING THE EMERGENCY PUMP DRIVE (E-DRIVE)...................... 32 4.1 Emergency Drive Initial Set-Up ............................................................. 32 4.2 Transferring PLU Disposable to E-Drive................................................ 33 4.3 Manually Powering The E-Drive............................................................. 33 4.4 Transferring PLU Disposable from E-Drive to new Pump Driver........... 34 5. INITIAL EQUIPMENT SET-UP..................................................................... 35 5.1 Initial Equipment Set Up / Contents ....................................................... 35 5.2 Installation Checkout Procedures.......................................................... 37 6. PLU DISPOSABLE SET-UP & PRIMING PROCEDURE............................ 38 6.1 Required Equipment............................................................................... 39 6.2 PLU Disposable Kit Contents................................................................. 39 6.3 Priming Kit Set-Up.................................................................................. 40 6.4 Priming Process (Blood Tubing) ............................................................ 41 6.5 PLU Disposable De-Airin........................................................................ 42 6.6 Pump Circulation De-Airing ................................................................... 42 7. PRE-USE CHECKOUT PRIOR TO PATIENT USE...................................... 43 7.1 Connecting Gas Tubing........................................................................... 43 7.2 Pre-Use Checks (Before Placing on Patient)......................................... 44 8. CONNECTING TO PATIENT & INITIATION OF THERAPY ....................... 46 8.1 Presenting Primed PLU Disposable to Surgical Team in Sterile Field.. 47 8.2 Adjust Blood Flow to Target Flow Set Point .......................................... 47

9. MONITORING & ONGOING MAINTENANCE............................................. 48 9.1 Ongoing Monitoring During Therapy...................................................... 48 9.2 Sighing Function..................................................................................... 50 9.3 PLU Disposable Change-Out Procedure............................................... 51 9.4 Troubleshooting Common Problems During Therapy............................ 53 10. DISCONTINUATION/TERMINATION OF THERAPY................................ 54 10.1 Terminating Therapy............................................................................. 54 10.2 Disposal of Single Use PLU.................................................................. 54 11. CLEANING & DISINFECTION.................................................................... 55 11.1 Cleaning Touchscreen .......................................................................... 55 11.2 Cleaning and Disinfection After Each Use........................................... 56 12. PUMP & OXYGENATOR PERFORMANCE DATA.................................... 57 12.1 Pump Hydraulic Performance............................................................... 57 12.2 Transmembrane Pressure.................................................................... 57 12.3 Oxygen Transfer Rate (Internal & External Gas Mode) ...................... 58 12.4 CO2 Transfer (Internal & External Gas Mode) ..................................... 58 13. EXPORTING DATA..................................................................................... 59 14. SERVICE & PERIODIC MAINTENANCE .................................................. 60 14.1 Service & Repair - Guidance ............................................................... 60 APPENDIX A: ELECTROMAGNETIC RISKS................................................. 61 APPENDIX B: ELECTRICAL SAFETY TESTS .............................................. 64 Leakage Current .......................................................................................... 64 APPENDIX C: COMPLIANCE TESTING & STANDARDS ............................. 65 APPENDIX D: OXY-1 PART NUMBERS ......................................................... 66 APPENDIX E: OPERATOR ASSISTANCE ..................................................... 66

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WARNINGS & CAUTIONS WARNING! GENERAL USE • Read all instructions prior to use. Improper use could result in death or injury to the patient or user, or damage to the OXY-1 System. • The OXY-1 System must be operated and monitored by trained individuals under the direction and prescription of a physician. • Cardiopulmonary Bypass requires the use and monitoring of anticoagulants to prevent clotting. • Patients receiving therapy require hemodynamic monitoring to assess circulatory performance and arterial blood gas monitoring to evaluate adequacy of gas exchange. Patients should also have continuous SpO2 to monitor blood oxygenation. • Operate the OXY-1 System in accordance with this manual over the specified range. • Use of this device at an altitude above 7000 ft above sea level or outside a temperature of 10-30C or a relative humidity above 90% Rh is expected to adversely affect the flowrate and the percentage of oxygen and consequently, quality of therapy. • Do not operate the pump without closing the latching mechanism on the Pump Driver. This can be verified through inspection. Improper or partially closing the latch will result in improper blood flow reporting. • Do not use grease or oils to lubricate the oxygen inlet and outlet ports to avoid the risk of fire and burns. • The OXY-1 System is not intended for use in a medical transport (e.g., by ambulance, helicopter or fixed-wing aircraft) environment. WARNING! BLOOD/FLUID MANAGEMENT • Avoid clamping the blood tubing to halt blood flow while the pump is operating to minimize damage to the blood (hemolysis). • Do not insert or remove the Disposable while the motor is running to avoid pump damage. • Do not operate the pump without priming the PLU Disposable with fluid prior to starting. • Frequently inspect for leaks throughout the entire Disposable circuit. • Ensure all blood connection points (tubing connectors) are firmly inserted and securely attached. The use of tie bands is recommended on all blood connection points. • Excessive positive or negative pump pressure can result in hemolysis, cavitation, collapse of the vessels surrounding the cannula and/or greater vessels causing interruption of therapy.

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WARNING! GAS MANAGEMENT • External Gas Mode: Only use medical grade oxygen gas source fitted with a flowmeter that meters flow between 0-15 LPM. • Sweep gas flow rate settings may be different between External Gas Mode and Internal Gas Mode settings. Internal Gas Mode flow uses an oxygen and air combination and may require higher sweep gas (total flow) to achieve equivalent CO2 elimination when compared to External Gas Mode. • When operating in Internal Gas Mode, access to a backup oxygen supply source is required in the event of a system failure. WARNING! EQUIPMENT SET UP AND POSITIONING • Position the Pump Lung Unit (PLU) below the level of the patient’s heart. • Always have tubing clamps available to halt blood flow or prevent retrograde flow. • DO NOT operate the OXY-1 System in the presence of flammable gases. An explosion hazard exists under these conditions. • DO NOT operate the device in an enclosed space, such as a closet. • DO NOT block the air inlet or the exhaust vents located on the front and side of the device. • DO NOT cover the device with a towel, blanket, etc. WARNING! PLU DISPOSABLE • Inspect PLU Disposable sterile package for damage prior to opening. Do not use if there is damage or breach of the sterile barrier, as this could result in contamination and severe infection. • Verify the PLU Disposable kit expiration date has not been exceeded prior to use. • Thoroughly prime and de-air the PLU blood circuit prior to use. • DO NOT reuse or re-sterilize single-use PLU Disposable.

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CAUTION! • A fully discharged battery will take no less than 180 minutes to return to a fully charged state. Allow adequate time for the batteries to fully recharge before placing in service. • Batteries will discharge slowly in storage (without AC power attached). Maintain AC power source when not in use to maintain a maximum charge. • Do not operate the pump drive with the PLU Disposable removed. • Do not operate the pump without priming the PLU Disposable with fluid prior to starting. • Do not remove the PLU Disposable while in operation or attempt to install or reinstall the PLU while the pump is in operation. This may cause damage to the pump. • Lock the four wheel castors before operating the OXY-1 System. • Verify the PLU Disposable and Pump Driver are securely and correctly fitted, to each other and the IV Pole Mount. • Remove the OXY-1 System from service if it has been exposed to mechanical shocks and once removed, inspect for damage. • If the Console touchscreen malfunctions, remove it from service. • Confirm the E-Drive is available and securely attached. • Confirm E-Drive is accessible and can be operated without interference. • Do not block the air intake duct on the Console. Poor air flow will reduce performance and potentially cause the OXY-1 System to malfunction. NOTE: • Hemolysis is often precipitated by excessive pump speed, the presence of thrombosis and the entrapment of air bubbles in the blood circuit and pump. Noise emanating from the pump is often an indicator of air bubbles in the pump impeller. Frequent and routine visual and audio inspection of the blood circuit is necessary. Immediate removal of air bubbles and clots is recommended to minimize blood damage. • Only use the components described within this manual with the OXY-1 System. • Additional data not included in this manual is made available upon request. This may include but is not limited to: • sterilization method • list of materials of the blood pathway • data related to blood cell damage (hemolysis) • particle release from the oxygenator according to Breethe’s quality control management • gas pathway pressure drops at the maximum blood and gas flow rates specified for intended use • blood pathway pressure drops at the range of blood flow rates specified for intended clinical use • relevant tolerances for data presented

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TECHNICAL SPECIFICATIONS *Items noted with an asterisk indicate essential performance.

PUMP & OXYGENATOR PUMP LUNG UNIT

Blood Flow Rate

0.5 – 5 LPM @ 500 mmHg*

Transmembrane Pressure (@ 5 LPM) 45-55 mmHg

Pump Priming Volume

34 ml

Oxygenator Priming Volume

285 ml

O2 Transfer TUBING

Full Range > 95% Saturation*

Size

3/8” ID x 12 ft. (9.5 mm ID x 3.7 m); 3/32”

thickness

Blood Tubing Priming Vol (uncut)

500 ml -Drainage & Return Tube Full Length (12ft.)

PUMP DRIVER

Driver Dimensions (L x W x H)

10.8 x 6.3 x 5.6 inches (275x160x144 mm)

Driver Weight/ Mass (w/o PLU Disposable)

2.9 lbs. (1.3 kg)

Flow & Bubble Detection Sensors Ultrasonic flow and bubble detection

Mount

25-40mm Dia. IV Pole Mount

CONSOLE / PUMP CONTROLLER

Pump RPM range

0-4500 RPM in 50 RPM Increments

Blood Flow Accuracy

+/- 0.3 LPM 0-2 LPM, ±15% > 2 LPM

Bubble Detection

Detectable bubble size > 4 mm diameter

SWEEP GAS MODES: EXTERNAL OXYGEN / INTERNAL GAS SUPPLY

External Gas Mode; Flow Meter Internal Gas Mode: Sweep Gas (setting)

Flow rate < 15 LPM from external flow meter O2 barb tubing connector Oxygen: 0.5 – 3 LPM greater of ± 10% LPM or ± 0.2 LPM, 91% ± 6% Oxygen concentration* Air: 1.0 – 15 LPM greater of ± 10% or 0.5 LPM Air*

Internal Gas Mode Warm-up Time 4 minutes @ 0.5 LPM

Sigh Function

(Available in Internal Gas Mode only)

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POWER

AC Mains

5.0 A, 100-240 VAC, 50/60 Hz

Battery Type

Lithium Ion

Battery Run Time

200 minutes (see Section 14)

Battery Charge Time (from zero state) < 180 minutes on Standby or

< 6.5 hours on Run Mode

CONSOLE

Graphical Display

Touch Screen Control / Capacitive

Console Dimensions (H x W x D)

26 x 14 x 9 Inches (66 x 36 x 23 cm)

Console Weight/ Mass

47 lbs./ 21.5 Kg

Wheels

Locking Wheel Castors

Handle

Foldable Handle

System Alarm Sound Pressure Level > 60 dBA

E-DRIVE

RPM Range

0-5000 RPM

Power

Manual Hand Crank

ENVIRONMENTAL CONDITIONS

Storage Conditions:

Durable (Console & Pump Driver) 10-30 C and 5-85% RH noncondensing

PLU Disposable Kit

10-30 C > 85% RH noncondensing

Operating Conditions

10-30 C and 15-90 RH noncondensing

Altitude

Sea level to 7,000 feet

Atmospheric Pressure

101-78 kPa

Air Quality

Free of smoke, pollutants, and fumes.

Water Ingress Protection Level

IPX-1: Dripping water with vertically falling drops

COMPLIANCE STANDARDS See Appendix C (AS OF 2020)

Disposable Sterilization Method

Ethylene Oxide

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GLOSSARY OF TERMS Blood Circuit – the disposable blood circuit including the PLU Disposable, blood tubing and accessories that are in contact with the blood. Clot/Thrombus – a coagulated blood mass formed within the vascular system of the body or blood circuit that impedes blood flow or gas exchange. Condensate Tray – a single use disposable intended to trap condensation generated by the sweep gas exhaust to prevent excessive water leakage. Console – the controller subsystem that allows the user to control the pump speed and manage sweep gas, power, and therapy delivered. Drainage Line – blood circuit tubing (blue stripe) carrying the unoxygenated blood from the patient to the pump and membrane oxygenator (outflow). De-air – the process of removing air and air bubbles from the blood circuit. Device Performance Data – data that is accessible by the User to review the OXY-1 System setting and output data over time. Durable Components – the Console, Pump Driver assembly, pole mounting interfaces and EDrive components declared reusable after cleaning and disinfection. Hemodynamic Monitoring – the measurement of pressure, flow, and oxygenation of blood within the cardiovascular system. PLU – (Pump Lung Unit) the disposable assembly that contains the pump and oxygenator assembly. PLU Cable Guard – a protective sheath and strain relief used to protect the PLU electrical cable and gas tubes between the Pump Driver and Console. PLU Disposable – a single use disposable that contains the pump and oxygenator assembly, Air and O2 tubing, Luer blood extension tubes, caps, priming kit and corresponding packaging. PLU Mounting Bracket – a mounting bracket used to secure the PLU to the IV pole in either a vertical or horizontal position. Pre-Use Checkout – procedures required to confirm OXY-1 System readiness just prior to patient use. Priming Volume– the volume of priming fluid required to fill and de-air the blood circuit. Recirculation – recirculating fluid through the blood circuit.

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Recirculation (Venovenous) – a phenomenon where oxygenated blood returned by the system is drawn back through the drainage circuit and recirculated. This often occurs when the drainage and supply cannula are positioned too closely, blood flow settings are too high causing recirculation, and/or a combination of these factors. Return Line – the blood tubing (red stripe) carrying the oxygenated blood from the membrane oxygenator to the patient (inflow). Sigh – the process of driving gas through the gas exchange membrane at a high flow rate to remove condensation that accumulates in the gas path. Stopcock – a three-way valve placed in series with a blood access port used for accessing blood in the circuit. Sweep Gas – gas (oxygen, or oxygen and air) that passes through the oxygenator membrane where oxygen diffuses into the blood and carbon dioxide (CO2) diffuses into the gas flow for CO2elimination. The rate of the sweep gas flow controls the quantity of oxygen saturation and the rate of CO2 elimination from the blood that passes through the oxygenator. V-A – Venoarterial cannulation – cannulation of the patient’s greater vessels where the drainage cannula is placed into the venous side of the body and the return is in the arterial side of the body. V-V – Venovenous cannulation - cannulation of the patient’s greater vessels where the drainage cannula is placed into the venous side of the body upstream of the right side of the heart and the return cannula is placed in the venous side downstream of the drainage cannula.

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1. OXY-1 SYSTEM DESCRIPTION The Breethe® OXY-1 System provides extracorporeal circulation for cardiopulmonary bypass support for up to six hours. The OXY-1 System includes a Disposable pump and oxygenator, blood tubing, a Pump Driver (blood pump), and Console for controlling the pump and managing gas flow. These components are designed to operate together, simplify operation, and reduce the overall equipment footprint at the bedside. The Pump and Oxygenator – An oxygenator and a centrifugal pump form a single use, permanently assembled Disposable called the Pump Lung Unit (PLU). The oxygenator has a polycarbonate exterior housing that encloses a polymethylpentene (PMP) hollow fiber membrane. A sweep gas passes through the interior lumens of the hollow fibers and gases exchange across the membrane with the blood in contact with the fibers. The centrifugal pump moves blood across the hollow fibers. The blood exits the PLU Disposable outlet and is delivered back to the patient. Pump Driver Unit – The Pump Driver encases the PLU Disposable, provides energy to the centrifugal pump and houses a flow sensor that monitors blood flow through the PLU Disposable. Energy and communication are provided to the Pump Driver Unit via a 2-meter communication cable that is connected to the Console. The cable allows the Pump Driver to be mounted proximal to the patient on an IV Pole.

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Blood Tubing – 3/8” inner diameter, 3/32” thick PVC tubing (Drainage and Return flow) with a maximum working pressure of 650mmHg are attached to the PLU Disposable to provide a conduit for blood to circulate to and from the patient. The 12 ft. length tubes are marked to indicate Drainage (outflow- blue) and Return (inflow- red) flow and cut to length by the physician depending on the physician’s preference and cannulation method. Console – The Console is an electromechanical, software-driven component that contains a computer and touch screen User Interface (UI) to enable the Operator to set pump speed, monitor blood flow and set sweep gas flow rate. The gas can be provided by an external flow metered gas source or from an internal oxygen concentrator and blower. The Console contains a set of alarms for monitoring and alerting the Operator when the OXY-1 System operates outside of its preset range or Operator defined alarm limits. The Console contains an integrated back-up battery system and gas supply (oxygen concentrator and blower) to provide a source of power and sweep gas when external sources are not available.

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OXY-1 CONSOLE User Interface External O2 Source Interface

Disposable Gas port interface AC Power Cord Interface

The Console is fitted with a cable interface for connecting to the Pump Driver (C1) and a tubing interface for circulating sweep gas to the oxygenator in the PLU Disposable (T1 & T2). This interface is located on the rear left side of the Console, adjacent to the handle. The Console is fitted with a standard tubing connector located on the left side of the Console for receiving oxygen from an external source. This interface allows the operator to control the sweep gas flow from an external source such as a wall O2 flowmeter or a portable oxygen flowmeter.

The OXY-1 System can operate in two modes: External Gas Mode, where oxygen is supplied by an external metered gas source; or, as a backup Internal Gas Mode, where sweep gas is supplied by an internal gas source. The Internal Gas Mode is activated when external gas flow is no longer detected and either internal gas flow settings are greater than 0 LPM. When transitioning from External to Internal Gas Mode, the onboard oxygen concentrator requires a warm-up period to achieve optimal performance prior to switching (removal of the external gas source). See section 1.2.1 for instructions on the O2 Concentrator Warm-up.

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1.1 THEORY OF OPERATION 1.1.1 OXYGENATOR GAS EXCHANGE The Breethe PLU Disposable is an integrated pump and oxygenator. The oxygenator contains a polymethylpentene (PMP) hollow fiber membrane mesh. The hollow fiber membrane is a straw tube-like structure with a gas permeable wall. Approximately 30,000 fibers (each 380 microns in diameter) are woven into an array, restraining and aligning the fibers in an axial direction. These fibers are wound into the cylinder shape. Urethane restrains the fibers in place at both ends of the oxygenator housing. Blood is pumped through the oxygenator from the outside perimeter of the fiber cylinder, passes through the fiber bundle in a radial direction until it reaches the center, then exits in an axial direction at the top. Sweep gas is directed towards the end of the cylinder bundle and through the center of the hollow fibers, entering one end and exiting (exhausting) the opposite end. The cylindrical geometry is designed to provide uniform blood flow across the membrane with minimal opportunity for stagnation. As blood passes through the bundle, it contacts the surface of the membrane fibers where oxygen and carbon dioxide diffuse across the membrane, into and out of the blood respectively. The flow rates of the sweep gas affect blood oxygen saturation and carbon dioxide elimination. 1.1.2 PUMP The PLU Disposable is an integrated (combined) pump and oxygenator. The pump design uses a centrifugal pump containing a single pivot bearing. The design has been optimized to reduce hemolysis and provide the hydraulic power for both V-V and V-A applications. Pump speed is controlled by RPM setting only. 1.1.3. OXYGENATOR SWEEP GAS DIVIDER Sweep gas provides oxygen for blood saturation and carbon dioxide elimination from the blood to the gas stream. The oxygenator sweep gas pathway is divided to enable independent gas delivery to each segment, without blending. This division in the gas path separates the gas that passes through the surface area of the oxygenator’s inner core from an outer surface area (see figure below). In External Gas Mode, oxygen supplied to the OXY-1 System is delivered to the inner and outer portions of the oxygenator membrane (entire surface area) like typical oxygenators on the market. In Internal Gas Mode, oxygen from the concentrator is delivered to the center 75% of the surface area for oxygen saturation, and the remaining 25% of the outer ring is supplied with air for CO2 removal. This allows for lower flow oxygen to fully saturate the blood, and additional air flow can be used to supplement CO2 elimination for patients with a sweep flow demand greater than what can be managed by the concentrator’s maximum rate of 3 LPM. In Internal Gas Mode, and as a backup only, air and oxygen flow can be adjusted separately through the graphical user interface.

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1.1.4. CONSOLE PNEUMATIC CIRCUIT The OXY-1 System is designed to deliver sweep gas using an external oxygen metered gas source or an internal gas source. The Console is fitted with a pneumatic circuit to manage gas flow from either source to the PLU Disposable containing the oxygenator. The pneumatic circuit contains a sensor that detects the presence of gas from external gas port (located on the left side the Console). When external flow is present, the pneumatic circuit divides the flow into two gas paths and exits the Console at two terminal tubing port connectors located on the top left rear side of the Console. The tubing connectors are different sizes to match the two gas tubes supplied with the PLU Disposable. The gas circuit tubes attach to the Console for the gas path from the Console to the PLU Disposable. When gas flow from the external gas port is no longer detected, the OXY-1 System activates the onboard oxygen concentrator and blower to deliver the flow preset by the user. When the activation occurs, the pneumatic circuit closes a valve that separates the gas path so that the oxygen and air travel down the separate gas pathways to the oxygenator as described in above section 1.1.3. It is recommended that a gas circuit integrity test be performed before connecting to a patient. This is to ensure gas lines are properly connected and devoid of leaks that may lead to reduced oxygenation/CO2 removal, delays in therapy and potential harm to the patient. See section 7.2.4 for procedure. 1.1.5. INTERNAL GAS MODE Internal Gas Mode is intended to be a backup operational mode to External Gas Mode. The Console is fitted with an oxygen concentrator and air blower. The oxygen concentrator brings in room air, compresses gas into a sieve, and separates nitrogen from the air to produce oxygen. Typical oxygen concentrations are greater than 93% and maximum flow rates are constrained due to machine size. In Internal Gas Mode, the oxygen delivery from the concentrator is limited to 3 LPM. The air blower takes filtered room air in a separate gas path and delivers it to the outer segment of the oxygenator for increased CO2 elimination when flow rates greater than 3 LPM from the concentrator are required to match the patient demand. See Section 12 for performance data graphs. 1.1.6. CONDENSATION MANAGEMENT The exhaust gas from the oxygenator is typically 100% saturated with water vapor that can condense and collect on surfaces. The Pump Driver is fitted with a disposable absorbent disk and condensation tray that is placed directly beneath the PLU Disposable. The absorbent disk will capture condensation exiting the oxygenator either during normal use or the sighing function. Monitor the disk periodically for saturation. If saturated, replace the entire tray assembly.

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1.2 SPECIAL FUNCTIONS 1.2.1. O2 CONCENTRATOR WARM-UP The OXY-1 System has an integrated O2 Concentrator that provides O2 gas flow when operating in Internal Gas Mode. The O2 Concentrator has a warm-up period before full oxygen concentration output is achieved. The OXY-1 System’s User Interface features a warm-up function that should be performed prior to transitioning from External Gas Mode to Internal Gas Mode. Before the O2 Concentrator Warm-up can be enabled, the OXY-1 System must be in External Gas Mode and the Internal Gas flow settings must be greater than zero. After the O2 Concentrator Warm-up has been enabled, a white progress bar on the User Interface will indicate the warm-up status. Once complete, a message will appear on the touch screen indicating “Warm-Up Complete.” When in Internal Gas Mode, the O2 Concentrator outputs the user’s O2 flow setting. 1.2.2. SIGH FUNCTION (INTERNAL GAS MODE ONLY) Select this icon on the User Interface to initiate the sigh function to void condensate from the oxygenator. This is achieved by generating a series of oxygen pulses and increasing the air blower’s flow. The sigh function is a two-minute process and will return to normal operation after the process is completed. The sigh function can be suspended if pressed again. See Section 9.2 for instructions. In External Gas mode, the sigh function is controlled manually by increasing flow of the flowmeter from the external oxygen source. 1.2.3. BATTERY POWER MODE The Console operates on AC power or an internal lithium ion battery system. Battery mode is activated when AC power is removed. The onboard battery requires 180 minutes to completely charge from a fully discharged state while the unit is off, and 6.5 hours while the unit is running. From a fully charged state, the OXY-1 System will operate for minimum of 200 minutes in nominal operating conditions and will alarm when 20 minutes of operational battery capacity remain.

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2. OXY-1 SYSTEM OPERATING INSTRUCTIONS 2.1 ADJUSTING PARAMETERS 2.1.1 Touch Screen Display Select a parameter by touching the field or parameter directly. The selected parameter will transition from display mode to adjustment mode. The arrows located to the right side of the screen are used to increase or decrease parameter settings. The parameter will immediately change as the arrow fields are adjusted. After 10 seconds the display will return to the unselected state.

Alarm message field Pump Control field Sweep gas status & control field

Upper and Lower Alarm Setting Increase / Decrease Control

Sigh Function Icon

O2 Concentrator Warm-up Icon

Lock Screen Icon System Settings Screen

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OXY-1 System Parameters Software Version Battery Status

Delete Data

Return to Home Screen

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2.1.2 Lock Screen 1. Touch small "Lock" icon. 2. Touch and hold big "Lock" icon 3. Screen is now locked. 4. To unlock- touch anywhere on screen 5. Touch and Hold big "Lock" icon

2.1.3 Blood Flow Parameters

1. Blood Flow

a.

B  lood Flow is controlled by adjusting the pump RPM setting. The displayed

value is measured blood flow detected by the flow sensor.

2. Blood Flow Alarm Limits

a.

Touch the upper or lower value to enable adjustment.

b.

Tap the up/down arrows to adjust the Alarm Limit setting.

c.

Upper Limit range: 1.0 to 6.0 LPM or Off; Default: 5.0 LPM.

d.

Lower Limit range 0.0 to 5.0 LPM; Default: 2.5 LPM.

3. Pump RPM (Adjusting Blood Flow)

a.

Touch the Pump RPM field to enable adjustment.

b.

T  ap the up/down arrows to adjust the Pump speed setting – changes take

effect immediately.

c.

Pump speed range: 0-4500 RPM; Touch Increment: 50 RPM.

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2.1.4 Sweep Gas Flow Parameters

NOTE: • When operating in Internal Gas Mode, access to a backup oxygen supply source is required in the event of a system failure. • When transitioning to Internal Gas Mode, always perform O2 Concentrator warm-up to avoid transient reduction in oxygen delivery to the oxygenator. • Sweep rates in Internal Gas Mode settings may need to be higher to achieve equivalent CO2 elimination when compared to External Gas Mode. See Data Performance Section 12 for CO2 elimination curves.

External Gas Mode

1. External O2 gas source is activated when an oxygen source is connected to the Console O2 inlet and flow is detected (> 0.5 LPM). The OXY-1 System will automatically switch to External Gas Mode. 2. G  as flow rate is controlled by the source O2 flow meter. The OXY-1 System does not control or measure the gas flow rate of the External O2 source. 3. Oxygen is delivered to the entire oxygenator during External O2 mode. (per section 1.1) Internal Gas Mode

1. Internal Gas Mode, which serves as a backup operational mode, is automatically activated when the external gas source flow is no longer detected or has been removed (< 0.5 LPM).

2. Gas flow delivery is adjusted by using the Console User Interface for oxygen and air separately.

3. Oxygen Setting

a.

Touch the O2 flow field to enable adjustment.

b.

Tap the up/down arrows to adjust the O2 flow setting. The changes will take

effect immediately. Note that there is a warm-up period for the Internal O2

source (see section 1.2.1)

c.

O2 flow range: 0.0-3.0 LPM; Touch Increment: 0.5 LPM

4. Air Setting

a.

Touch the Air flow field to enable adjustment. The field will highlight indicating

it is ready.

b.

Tap the up/down arrows to adjust the Air flow setting. The change will take

effect immediately.

c.

Air flow range: 1.0-15.0 LPM; Touch Increment: 0.5 LPM

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2.2 DISPLAY ICONS & DESCRIPTION DISPLAY ICONS DESCRIPTION Alarm Indicator – If an alarm condition is detected, a flashing notification will be displayed. See Section 3.2 for additional information. Blood Flow – Measured blood flow in liters per minute (LPM). Range: -10 to +10, Resolution 0.1 LPM. Blood Flow Alarm Limits – If the measured blood flow is outside this set range, then an alarm is activated. The limits are Operator adjustable. Pump Setting – Operator controlled blood pump speed setting in revolutions per minute (RPM). Range: 0 to 4500 in 50 RPM increments.

Disabled Disabled

Up Arrow – When enabled, touch control to increase a selected value. Hold to rapidly increase selected value. Enabled Down Arrow – When enabled, touch control to decrease a selected value. Hold to rapidly decrease selected value. Enabled Internal Gas Disabled – Whenever External Gas is detected, OR both Air and O2 settings are 0.

Internal Gas Enabled – When External Gas is not detected, AND either Air or O2 settings are > 0. Operator controlled Air flow setting: 1.0 to 15.0 LPM in 0.5 LPM increments. Operator controlled O2 flow setting: 0.0 to 3.0 LPM in 0.5 LPM increments. External O2 Not Detected – External gas source is not connected OR no flow is detected (< 0.5 LPM). Internal Gas Mode is activated.

External O2 Detected – Flow from an external gas source is detected (> 0.5 LPM). Internal Gas Source will automatically deactivate.

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Off Selected

Enabled

Off Selected

Enabled

Touch to return to Home screen. Touch to access the Settings screen. Indicates the touch screen is unlocked. Touch the icon to start the screen lock process. Indicates the screen is locking/unlocking. Touch and hold the icon until the inner circle fills to complete either process. Orange lock indicates the touch screen is locked. Indicates the OXY-1 System is powered by AC power. Otherwise the OXY-1 System is powered by Battery. Sigh control. Press icon to select, Press radio button to activate the sigh process. Sigh process is only available in Internal Gas Mode. See “Sighing” for additional information. Sigh status. White progress status bar will increase until complete. O2 Concentrator Warm-up control. Press icon to select, press radio button to activate the warm-up process. See “O2 Concentrator” for additional information. O2 Concentrator Warm-up status. White progress status bar will increase until complete. O2 Concentrator Warm-up completion notification. The system is ready to have external gas disconnected. O2 Concentrator Warm-uperror message. Set internal O2 flow rate and initiate sequence. O2 Concentrator Warm-up error message. Reconnect external gas, set internal O2 flow rate and initiate sequence. O2 Concentrator Warm-up error message. External gas has been disconnected and internal O2 flow has been detected. Check settings.

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The Battery icons indicate the current battery capacity. The OXY-1 System will alarm when there is 20 minutes of battery remaining. Alarm Volume setting: Soft, Moderate or Loud. Sample alarm will play with each volume change. Bubble Alarm Limit setting: Off, Small, Medium, or Large sensitivity. Date and Time setting: Select each date and time item to adjust using arrows. Touch orange clock icon to save changes. Clear Stored Data: When touched, the instructions and control mechanism to clear the OXY-1 System data are visible. Software Version 2.3 INSTALLING PLU DISPOSABLE INTO PUMP DRIVER WARNING! • Never install or remove the PLU Disposable while the Pump Driver is running (RPM > 0). This could cause pump damage or pump malfunction. 1. O  pen Pump Driver lid by raising the left latch lever and releasing the latch arm from the latch plate. 2. Open the top latch plate. 3. Open the lid far enough to engage hinge detents. 4. A lign the PLU Disposable with the pump socket and seat the PLU Disposable into the Pump Driver. 5. Route Air and O2 tubing below latch lever. 6. Press Return line (red) tube into sensor channel firmly. 7. Press Drainage line (blue) tube into channel groove in the Pump Driver. 8. Close large lid (#1) and close top latch plate (#2) over the lid. 9. Engage latch arm to top latch plate (#3). 10. Lower latch lever to clamp the tubing in place (#4)

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3. ALARMS & TROUBLESHOOTING 3.1 ALARM DEFINITIONS, CONDITIONS AND ACTIONS The OXY-1 System alarms are divided into two (2) classes: therapy and technical. Therapy alarms are designed to alert the operator to a life-threatening change in patient therapy to include: no detectable blood flow, high flow rate, low flow rate and bubbles detected. Technical alarms indicate status of the mechanical and software elements of the OXY-1 System and can include battery status, concentrator status, air flow, sigh function and pump status. Any alarm message preceded with “System Failure” should alert the operator to initiate use of the E-Drive. CAUTION! • Setting extreme alarm values may render the OXY-1 alarm system effectively useless. • Access to the system should always remain unobstructed to allow for prompt and effective alarm message response and solution. • Auditory alarm signal sound pressure levels that are less than ambient levels can impede operator recognition of alarm conditions. 3.1.1 ALARM PRIORITY LEVELS & SOUND Alarm priority is indicated by the color of the flashing notification in the alarm bar at the top of the User Interface. A red color indicates a high priority alarm and a yellow color indicates a medium or low priority alarm. Once an alarm message is acknowledged, audio is paused for about 120 seconds before resetting. The Operator’s position for responding to an alarm is dependent on the specific message displayed. High Priority Alarm Medium Priority Alarm Low Priority Alarm Disabled Alarm – Appears next to the alarm parameter that has been disabled. No Alarm - bell symbol with no additional symbols or text.

Active Alarm – Audio will sound and alarm text displayed

Silenced/Acknowledged Alarm - The alarm audio has been silenced, but the underlying issue has not yet been resolved.

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3.1.2 Alarm Volume / Date and Time 1. Tap the Settings icon to enter settings screen. 2. Touch the Alarm Volume value to enable adjustment. 3. Tap the up/down arrows to adjust the setting: Soft, Moderate and Loud. 4. A sample alarm sound will play once with each new volume setting. 5. Touch any Date and Time value to enable adjustment. 6. Tap the up/down arrows to adjust the setting. 7. Touch orange clock to save settings. 8. Tap the Home icon to return to the home screen 3.1.3 Bubble Alarm Settings 1. Tap the Settings icon to enter settings screen. 2. Touch the Bubble Alarm Setting to highlight the field and enable adjustment. 3. Tap the up/down arrows to adjust the bubble size setting. 4. Tap the Home icon to return to the home screen.

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3.2 ALARM TROUBLESHOOTING 3.2.1. HIGH PRIORITY ALARMS

HIGH PRIORITY ALARMS

ALARM TEXT Air Flow Out of Range Alarm System Disabled Battery Failure 1 Battery Failure 2 Battery Runtime Unknown Battery Over Temperature

CONDITIONS FOR ALARM

SOLUTION

• Air flow sensor detects flow not within +/- 1.0 LPM of Air Flow setpoint for Internal Gas Mode • Loss of internal gas operating mode

• Verify gas tubing is properly connected on rear of Console T1 & T2. • Check for blocked or kinked air tubing • Switch to External Gas Mode and replace Console promptly

• Alarm System not functioning; no other • Verify therapy is being delivered and

alarms will be reported

replace Console promptly

• Two or more batteries fail to charge or • Restore AC power

discharge

• Replace Console

• Two or more batteries fail to communicate

• Restore AC power • Replace Console

• One or more batteries report operating • Check console filters for blockages

temperature above operating limit

• Replace Console

Blood Flow < 0 LPM

• Blood flow sensor detects negative flow

• Increase Pump RPM > 0

Blood Flow Sensor Failure Bubbles Detected High Blood Flow

• Flow sensor communication failure • Blood flow and blood bubble detection and alarms will not be triggered

• Replace Console and Pump Driver • If failure persists, use a 3rd party flow sensor; Pump RPM will still indicate pump function

•

Blood Bubble Sensor detects bubble size equal to or greater than the Bubble Alarm Limit Settings

•

Check for bubbles and purge as needed

• Blood flow sensor detects blood flow • Check Circuit

equal to or greater than the Blood Flow • Adjust Pump RPM

Upper Limit setting

• Adjust Alarm Limits

Low Battery Power

• Medium priority low battery power alarm • Restore AC power has been present for at least 10 minutes

Low Blood Flow

• Blood flow sensor detects blood flow equal to or less than the Blood Flow Lower Limit setting

• Check Circuit • Adjust Pump RPM • Adjust Alarm Limits

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HIGH PRIORITY ALARMS

ALARM TEXT

CONDITIONS FOR ALARM

SOLUTION

Oxygen Concentrator Failure 1 • Internal temperatures reported out of range • Switch to External Gas Mode

• External gas source not present

• Check for blocked air inlet

Oxygen Concentrator Failure 2 • O2 Concentrator communication failure • External gas source not present

• Switch to External Gas Mode • Replace Console

Oxygen Concentrator FiO2 < 72%

• O2 Concentrator detects internal source O2 • Switch to External Gas Mode

concentration is < 72%

• Replace Console

• Loss of Internal Gas Mode

Oxygen Concentrator Flow Out of Range Pneumatics Failure Pump Control Failure 2

• O2 Concentrator detects internal source O2 flow is not within +/- 0.5 • LPM of Oxygen Flow setpoint

• Check for blocked or kinked O2 tubing • Switch to External Gas Mode and replace Console

• External gas pressure sensor communica- • Check the external gas connec-

tions failure

tion

• External gas pressure source is not between • Switch to Internal Gas Mode

-2.5 PSI and 20 PSI

• Replace console

• Pump encoder failure

• Verify blood flow rate

• Pump is attempting to run in block commu- • Replace Pump Driver

tation mode without using encoder

Sigh Function Failure System Failure: Internal Power 1

• Sigh process detected insufficient O2 pressure while sigh valve closed (when sigh is activated) • Loss of internal gas operating mode • PLU power is in over-current condition • PLU pump and blood flow and bubble sen- sor power turned off and will not function

• Switch to External Gas Mode • Replace Console • Initiate E-Drive • Replace Console and Pump Driver

System Failure: Internal Power 2 System Failure: No External Power

• One or more power rails within the Console • Initiate E-Drive

is in over-current condition

• Replace Console and Pump

• Faulted power rails turned off and will affect Driver

vital system functionality

• Two or more batteries report discharging while console is connected to external power

• Remove and replace console • Replace batteries

System Failure: Pump Control 1 • Pump communications failure • Pump will not be spinning System Failure: Pump Drive • Pump-reported RPM is not within +/- 100 RPM of Pump RPM setpoint

• Check Pump Driver’s electrical cable for connection • Initiate E-Drive • Replace Console and Pump Driver • Initiate E-Drive • Replace Console and Pump Driver

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3.2.2. MEDIUM PRIORITY ALARMS

MEDIUM PRIORITY ALARMS

ALARM TEXT Battery Failure 1

CONDITIONS FOR ALARM

SOLUTION

• One battery fails to charge or discharge • Restore AC power • Replace Console

Battery Failure 2

• One battery fails to communicate

• Restore AC power • Replace Console

Low Battery Failure 2

• Remaining battery runtime less than 20 • Restore AC power minutes • First battery power alert

Oxygen Concentrator FiO2 < 85%

• O2 Concentrator detects internal source • Switch to External Gas Mode

O2 concentration is < 85%

• Replace Console

• Loss of Internal Gas Mode

System Failure: No External • One battery reports discharging while • Self-clearing

Power

console is connected to external power • Contact your Breethe service rep

3.2.3. LOW PRIORITY ALARMS

LOW PRIORITY ALARMS

ALARM TEXT

CONDITIONS FOR ALARM

SOLUTION

Lost External Gas

• Console has previously been removed from external gas source

Oxygen Concentrator Failure 1 • Internal temperatures reported out of range • External gas source present

• Acknowledge alarm by touching screen • Reconnect to external gas OR • Adjust Internal Gas Settings to continue therapy • Check for blocked air inlet Replace Console

Oxygen Concentrator Failure 2 • O2 Concentrator communication failure • Replace Console • External gas source present

Running on Battery

• Console has previously been removed • Acknowledge alarm by touching

from external power source

screen

• Monitor battery life icon

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4. OPERATING THE EMERGENCY PUMP DRIVE (E-DRIVE) WARNING! • Placing the Pump Driver above the level of the patient’s heart is not recom- mended. In the event of a System Failure, static negative pressure caused by retrograde blood flow into the Pump Lung Unit may create negative static pressure in the blood circuit and cause air to ingress across the oxygenator membrane. • Verify the operator can install the PLU Disposable and operate the hand crank unobstructed. Inability to access will interrupt therapy when the E-Drive is needed in the event of an emergency. CAUTION! • Placing the Pump Driver higher than 21 inches from the floor can cause a tip hazard that may cause damage to the OXY-1 System and compromise performance. • Misaligning the PLU Disposable can result in therapeutic disruption. • Verify the Pump Driver is properly mated to the mounting bracket. Improper at- tachment can cause the pump to detach and fall, causing damage to the OXY-1 System and compromising performance. • Take caution when moving or transferring the PLU Disposable- dropping can result in blood pump damage, circuit damage and/or patient blood loss. 4.1 EMERGENCY DRIVE INITIAL SET-UP The E-Drive is a manual pump driver used in the event of pump function failure. Always ensure the crank handle path for the E-Drive is unobstructed to manually power the PLU Disposable when necessary. Consider all factors required to transfer the PLU Disposable from the Pump Driver to the E-Drive, including blood tubing orientation, gas tubing, cables, etc.

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4.2 TRANSFERRING PLU DISPOSABLE TO E-DRIVE 1. Unzip Cable Guard to expose the gas tubing and cable. 2. Clamp blood tubing to prevent retrograde flow. 3. If the pump is not already stopped, set Pump RPM to 0. 4. Remove PLU Disposable from Pump Driver. 5. Align and latch PLU Disposable to E-Drive. 6. Maintain gas tubes connections between the PLU Disposable to Console. 7. Verify gas flow from either internal or external gas source. 4.3 MANUALLY POWERING THE E-DRIVE 1. Unfold E-Drive handle. 2. Crank handle clockwise to initiate blood flow. Unclamp blood tubing. 3. Adjust cranking rate to achieve desired blood pump RPM as shown on the LED display.

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4.4 TRANSFERRING PLU DISPOSABLE FROM E-DRIVE TO NEW PUMP DRIVER 1. Power up the new OXY-1 System Console. 2. Clamp blood tubing to prevent retrograde flow. 3. Stop cranking E-Drive handle. 4. Wait for the E-Drive to stop. 5. Press & hold E-Drive release button. 6. Unlatch the PLU Disposable from E-Drive. 7. Attach the PLU Disposable to the new Pump Driver. 8. Gradually increase Blood Pump RPM. Unclamp blood tubing. 9. Move tubing from external oxygen source (wall or tank) to new Console oxygen inlet. 10. Move Air and O2 tubing from the old Console to the new Console. 11. Reattach the Cable Guard. E-Drive Release Button

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5. INITIAL EQUIPMENT SET-UP WARNING! • Complete the installation checkout procedure section of this manual before put- ting the OXY-1 System into operation. If the OXY-1 System fails any portion of the checkout procedure, it must be removed from use and repaired. NOTE • Before any assembly, test, or checkout procedures can be performed on the OXY-1 System, a Breethe Representative must complete an on-site battery installation procedure. • Do not plug the Console into AC power until after the batteries have been connected. • A hospital supplied IV pole is required for the OXY-1 System configuration. The IV Pole must meet the following minimum requirements: 25-40mm diameter pole, 20 kg load capacity, and a wheeled, 5-leg, 24-inch base. Locking wheels are recommended. 5.1 INITIAL EQUIPMENT SET UP / CONTENTS The OXY-1 System’s durable components are packaged separately from the PLU Disposable. The durable portion of the OXY-1 System is shipped in a package containing the following: • Console (with power cord) • Pump Driver • Pole Mount • E-Drive • System Operator’s Manual

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5.1.1 MECHANICAL INSPECTION 1. Examine each item for any damage or missing parts. 2. E  xamine the power cord and cord retainer for any signs of damage. Replace if damaged. 3. Check all castors are in firm contact with the floor and the OXY-1 System is stable. 4. L ock castor brakes and verify the OXY-1 System remains in place and unlocks and moves smoothly. 5. V  erify the Console handle can be raised/lowered and locked securely in both positions. Handle operation instructions: a. Press hinge button to unlock handle. b. Rotate handle and release hinge button. c. Handle will re-lock once rotated fully in the raised or lowered position. 5.1.2 ASSEMBLY 1. Securely mount the Pole Mount to the IV Pole approximately 21 inches from floor. The arrow on the label of the bracket should point upwards. Apply downward pressure to the Pole Mount to verify it will not move. 2. Latch the Pump Driver into the Pole Mount. There will be an audible click. Lift up on the Pump Driver to ensure the latch is properly engaged. 3. Place the E-Drive onto the Pole Mount. 4. Mate the Pump Driver electrical cable to the Console connector labeled C1 located on the rear top of the Console. Lift the dust cover, align the red dots and fully mate the connector. CAUTION! • Verify the Pump Driver is properly attached (locked in place). Improper attachment can cause the pump to detach and fall, causing damage to the OXY-1 System and compromising performance.

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5.2 INSTALLATION CHECKOUT PROCEDURES 5.2.1 FUNCTIONAL CHECK 1. Connect the AC power cord to a wall outlet. 2. Switch the Standby switch to the ON position (located on the back of the Console.) 3. Verify the following as the OXY-1 System boots up: a. The screen is on and displaying the Breethe logo and OXY-1 System name. b. An audible alarm beep is heard. c. The blue battery charging LED is on or flashing. 4. V erify no alarms exist after OXY-1 System boot completes and the home page is displayed. 5. Switch the Standby switch to the OFF position. 6. K eep the OXY-1 System plugged in until the battery is fully charged (indicated by solid blue light). 7. V erify E-Drive is operational by manually cranking the handle clockwise. Increase RPM and LED display will indicate RPM from 1500 to 5000. 5.2.2 ELECTRICAL SAFETY CHECKS All OXY-1 Systems should be tested by the facility’s biomedical engineering team for safety prior to patient use. See Appendix B for recommended methods.

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6. PLU DISPOSABLE SET-UP & PRIMING PROCEDURE

WARNING! • Do not operate pump before the PLU Disposable has been properly primed. Operating the pump without fluid can cause damage to the pump. • Inspect for leaks throughout the entire circuit during the priming process. Verify connectors and access ports are closed. Minor leaks can cause major blood loss- do not use if leaks cannot be corrected.

NOTE • The PLU Disposable items must remain sealed until the contents are ready to be primed to maintain sterility. The tubing tray is labeled to notate proper orientation for opening during patient connection. • The maximum working pressure of the blood circuit tubing is 650mmhg.

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6.1 REQUIRED EQUIPMENT • (1) Configured OXY-1 System • (1) PLU Disposable kit • (3) 1-Liter IV bags (Priming Fluid) 6.2 PLU DISPOSABLE KIT CONTENTS • (1) Sterile Pump Lung Unit (PLU) Disposable • Coiled Air and O2 tubing • 3/8”, 500mL coiled blood tubing pre-attached in a dust cover tray • Priming circuit with recirculation bag and hanger • (2) Luer caps on PLU Disposable access ports • (1) 1/4" x 3/8” Hose Barb with Luer access port (white, non-vented cap) • (1) 3/8” x 3/8” Hose Barb with Luer access port (red, vented cap) • (1) Condensate Tray • (1) Cable Guard • (4) Luer lock extension tubes with 3-way stopcocks • (1) PLU Disposable Priming instructions • (1) 3/8” x 3/8” Hose barb with Luer access port (white, non-vented cap) • (1) Luer cap

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6.3 PRIMING KIT SET-UP

WARNING! • Inspect all sterile packaging for signs of damage. Discard and replace any items showing signs of damage. Sterility cannot be assured if packaging has been damaged or previously opened. • Verify the PLU Disposable kit expiration date has not been exceeded prior to use. • Aseptic technique should be maintained when setting up the PLU Disposable to prevent contamination of the circuit. The setup and priming process should be performed in a clean environment. • The Blood Tubing Tray should not be opened until the surgical team is ready to place the tubing into the sterile field. • Verify the blood port access connectors and caps are firmly attached (tight) and stopcocks are closed to prevent leaks. Leaks through blood access ports are a major source for circuit leaks. • Do not install the spare access port on the low-pressure side of the blood circuit due to increased risk of air entrainment.

1. I nspect the kit cover for signs of damage and check expiration date (see picture for location on label). 2. P  eel off the top cover of the PLU Disposable Kit tub. 3. R emove all pouched accessories and set aside. Do not open pouches. 4. M ove the clear Air and O2 tubing coil connected to the PLU Disposable and set outside the plastic tub, leaving the paper bands in place. 5. R  emove bands from the priming circuit and hang the recirculation bag on the bag hook and IV pole as shown. 6. U nfasten the hook-and-loop straps holding the Blood Tubing Tray and PLU Disposable. Remove and set aside for later use. 7. Place the PLU Disposable into the Pump Driver, leaving the Pump Driver lid open. 8. R emove and replace the red vented Luer cap in position (C) with a non-vented male Luer cap (white) OR with an extension tube and stopcock provided in the accessory pouches. 9. R emove and replace one OR both PLU Disposable access port caps (A & B) with an extension tube and stopcock as desired. 10. Confirm all Luer port connections are secure and stopcocks are closed.

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6.4 PRIMING PROCESS (BLOOD TUBING) 1. Close all clamps, large clamp (#1) and small clamp (#2). 2. Hang two (2) 1-liter IV priming fluid bags on the IV Pole. 3. R emove caps and insert priming bag spike ports into the IV bags as shown and allow the recirculation bag to fill with priming fluid. Periodically squeeze the recirculation bag to displace air bubbles back into the IV bags. 4. P osition the Blood Tubing Tray on a horizontal flat surface below the priming bag to aid in purging bubbles. 5. Open the large clamp (#1) and allow the fluid to enter the circuit. 6. R emove the Luer cap (D) to vent air out of the circuit and position the Luer port over the PLU Disposable Kit tub to catch priming fluid. 7. A llow air to escape the Luer port (D) until fluid expels into the tub and close after the major air bubbles are voided. 8. Open the small clamp (#2) to purge the remaining air into the recirculation bag. 9. Squeeze the recirculation bag to displace air bubbles into the IV bags. 10. Replace one of the IV Bags if empty and air is present in recirculation bag.

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6.5 PLU DISPOSABLE DE-AIRING WARNING! • Removing bubbles from the blood circuit is critical to preventing air embolism. Frequently inspect the circuit and take actions to remove bubbles from the circuit when bubbles are observed at the blood access port locations. • Do not operate the pump without closing the latching mechanism on the Pump Driver. This can be verified by inspection. Improper or partially closing the latch will result in improper blood flow reporting. 1. Remove PLU Disposable from the Pump Driver and inspect for trapped air bubbles. 2. M  anipulate the PLU Disposable to ensure air that may be trapped in the pump and oxygenator housing is dislodged and collects near the access port. This may require tapping the side of the PLU Disposable to migrate bubbles to the access port location. 3. Open the stopcock on blood access ports A or B to expel the air from the circuit. 4. Repeat steps 1 through 3 until no air bubbles are present. 5. P  urge the air from all Luer ports and extension tubes. Verify all ports are firmly tightened. 6. R eturn the PLU Disposable back to the Pump Driver. Secure the tubing and close the lid using the 4-step latch process (see section 2.3) 6.6 PUMP CIRCULATION DE-AIRING 1. H  ang the Blood Tubing Tray on the IV pole using the Velcro strap, and adjust the height to prevent any kinks in the tubing. 2. S  et the pump to 2000 RPM (an approximate flow rate of 2.0 LPM) and run for three (3) minutes. Allow priming fluid to purge air bubbles from the circuit. Squeeze the recirculation bag to displace air bubbles into the IV bags. 3. Increase the pump to 4500 RPM (an approximate flow rate of 6 LPM) and run for thirty (30) minutes to purge any remaining bubbles. Inspect the tubing for any restrictions if flow is significantly lower. 4. Inspect the entire blood circuit and tap on connectors to remove air bubbles while pump is running. 5. Stop the pump for final inspection of entire blood circuit. 6. If necessary, repeat the de-airing process as described in Section 6.5.

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7. PRE-USE CHECKOUT PRIOR TO PATIENT USE 7.1 CONNECTING GAS TUBING NOTE • When attaching the Cable Guard, start zipper at the Console end and draw towards the Pump Driver. • If the blue charging indicator is flashing, the internal batteries are not fully charged and may not provide the rated run-time if AC power is lost. 1. Remove the green and white caps from the ends of the gas tubing. 2. Connect the 3/16” ID O2 tube to 3/16” barbed fitting, T1, at the Console. 3. Connect the 1/4” ID Air tube to a 1/4” barbed fitting, T2, at the Console. 4. Open the zipper on the Cable Guard. Attach tab to Console button. 5. S  tarting at the Console, wrap the PLU Cable Guard around gas tubes and electrical cables and zip up the entire length. 6. Attach the Cable Guard tab to Pump Driver button. 7. Attach the hook/loop strap to the Cable Guard on the Console.

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7.2 PRE-USE CHECKS (BEFORE PLACING ON PATIENT)

7.2.1 CONSOLE

1. Confirm the following:

a.

Console Standby Switch is in the OFF position.

b.

O  XY-1 System is positioned near the patient in a well-ventilated area free of

pollutants and high humidity.

c.

The Console air intake and exhaust ports are not obstructed.

d.

Console handle is in the lowered and locked position.

e.

Console castors and IV pole castors (if equipped) are locked.

f.

P  ower cord is connected directly to a hospital grade wall outlet that meets the

OXY-1 System power rating requirements. See Technical Specifications or

rating label on back of Console.

2. Switch the Standby Switch to the ON position.

3. Confirm the following during power up:

a.

The screen is on and displaying the Breethe logo and OXY-1 System name.

b.

An audible alarm beep is heard.

c.

The blue battery charging LED is on or flashing.

4. After boot completes and the home page is displayed, confirm no alarms exist.

7.2.2 PUMP DRIVER

1. Confirm the Pump Driver is securely latched onto the Pole Mount. 2. Verify that the primed PLU Disposable is properly seated in the Pump Driver. 3. C heck that the blood tubing is properly seated into the channels of the Pump Driver flow sensor. 4. C heck that the lid is closed beneath the latch and the latch is fully engaged on the Pump Driver. 5. C  heck the blood circuit access ports for leaks. Tighten caps or adjust stopcocks as needed. 6. The gas tubing between the PLU Disposable and Console is properly connected. 7. T he Cable Guard is zipped over the gas tubing and electrical cable and buttoned at both ends.

7.2.3 BLOOD CIRCUIT CHECK

1. Increase the Pump RPM until the Blood Flow is 3 LPM. 2. Inspect the entire blood circuit and blood pump for bubbles. 3. If bubbles are present, stop the blood pump and eliminate bubbles (see section 6.5 & 6.6) 4. Set the Pump RPM to 0.

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7.2.4 GAS CIRCUIT INTEGRITY TEST WARNING! • Verify the integrity of all gas tubing connections and that the gas tubing is not obstructed. Loss in gas flow can result in insufficient O2 and CO2 transfer NOTE • A false-positive test result is triggered when the Air and O2 tubing are not com- pletely occluded during the test.

1. Remove external gas source (if connected).

2. Set Internal Gas, Air Flow to 15 LPM.

3. Set Internal Gas, O2 Flow to 3 LPM. 4. Wait 60 seconds for internal gas sources to reach max flow settings.

5. Clamp both the Air and O2 tubing.

6. Wait 60 seconds for the Console to detect flow errors:

a.

High Priority Alarm "Air Flow Out of Range"

b.

High Priority Alarm "Oxygen Concentrator Flow Out of Range"

7. If either flow error was NOT detected, this indicates there is a leak in the gas circuit.

8. Verify both gas tubing lines are firmly attached to the Console and repeat the test.

9. If either flow error was still NOT detected, the OXY-1 System should be removed from use.

10. Otherwise, release clamps on Air and O2 tubing. 11. Wait for the Console to clear the flow errors.

12. Set Internal Gas, Air Flow to 0 LPM.

13. Set Internal Gas, O2 Flow to 0 LPM. 14. Reconnect to external gas source.

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8. CONNECTING TO PATIENT & INITIATION OF THERAPY Verify Pre-Use check is completed prior to initiating therapy (Chapter 7) WARNING! • Always position the PLU Disposable and Pump Driver below the level of the patient’s heart. • Confirm the Drainage (Blue) and Return (Red) line are correctly set-up for the respective cannula. Incorrect tubing connection will result in reverse flow and potentially harm the patient. • If blood pump failure occurs, clamp the blood tubing to prevent retrograde flow. • Always set pump RPM to ensure sufficient blood flow and prevent retrograde flow before removing blood circuit clamps. • Excessive negative pressure and restriction on the Drainage line can result in cavitation and hemolysis. Excessive positive pressure and restriction on the Return line can result in cavitation and hemolysis. NOTE • Monitor the patient’s SpO2 for effectiveness during therapy.

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8.1 PRESENTING PRIMED PLU DISPOSABLE TO SURGICAL TEAM IN STERILE FIELD

1. C  lamp the Return (red) and Drainage (blue) on the priming side of the circuit near the Blood Tubing Tray.

2. O  pen the Blood Tubing Tray with the label oriented “This Side Up” and present sterile tubing to a surgical team member in the sterile field.

3. A team member in the sterile field will:

a.

C  lamp both tubes inside the sterile border of the Blood

Tubing Tray.

b.

C  ut the tubing between the clamps to separate the blood

tubing from the priming circuit outside the sterile field.

c.

R emove blood tubing from Blood Tubing Tray and place

into the sterile field.

d.

C  ut tubing to the desired length. Be sure to clamp tubing

near the cut to maintain the priming fluid in the circuit.

e.

P  lace the tubing ends of the primed circuit near the ends

of the cannulas.

f.

D  e-air the tubing and connector by continuously flushing saline while both

ends are mated.

g.

C  onfirm the correct drainage and return lines are connected to the appropriate

cannula.

h.

U nclamp the blood drainage/return lines on the PLU Disposable tubing and

cannula.

i.

A surgical team member will indicate patient readiness to initiate therapy.

4. Initiate blood flow by increasing the RPM setpoint on the main screen.

5. Inspect the circuit for blood movement and absence of leaks or bubbles.

6. Increase the flow rate gradually to prevent back flow of blood. Allow the blood to completely fill the circuit before increasing incrementally.

8.2 ADJUST BLOOD FLOW TO TARGET FLOW SET POINT

1. Begin sweep gas flow once blood flow starts and set to the desired set point. 2. I nspect the inflow and outflow tubing for color changes in the blood exiting the oxygenator. The outflow should be bright red in color. 3. Confirm that the parameter settings have been reached. 4. Providers may confirm the blood flow rate with an external flow sensor.

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9. MONITORING & ONGOING MAINTENANCE WARNING! • Patients receiving therapy require continuous monitoring to ensure gas delivery and transfer performance is adequate. This includes the use of SpO2 monitors, arterial blood gas monitoring and frequent inspection of the blood circuit. • Patients receiving therapy require the use and monitoring of anticoagulants to prevent thrombin formation and clotting. • The use of extracorporeal circuits for cardiopulmonary bypass can cause hemolysis and other changes in blood properties. Frequently monitoring the patient's blood properties for evidence of elevated plasma free hemoglobin (PFHb) is recommended.

9.1 ONGOING MONITORING DURING THERAPY Changes in patient condition and device performance require continuous monitoring of the patient and the OXY-1 system. Perform periodic inspections to ensure optimal delivery of therapy. The following are recommended actions related to the OXY-1 System delivery performance. 9.1.1 BLOOD FLOW CIRCULATION Monitor blood flow rate changes for a given RPM settings. Changes in blood flow may be an indication of several factors, including changes in the patient condition and flow restrictions in the circuit. 9.1.2 BLOOD CIRCUIT INSPECTION Begin by inspecting from one cannula, through the entire blood circuit, to the opposite cannula. Note that inspection may require the use of a flashlight to illuminate the circuit. If an anomaly is detected, action should be taken to remedy the issue. Inspect for the following: 1. Blood tubing is positioned and routed in a manner to prevent entanglement or accidental forces from being applied to the circuit that will strain the circuit, cause detachment and/or damage. 2. Migration or movement of the cannula from the location it was originally anchored and secured to on the patient. 3. Indications of blood loss. 4. Kinking or sharp bend radii in the blood tubing or cannula that may restrict blood flow. 5. Presence of clot formation throughout the entire blood path. 6. Presence or accumulation of air bubbles in the circuit.

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7. P resence of air bubbles in the pump head. This is often identified by a rattling noise at the pump. 8. Verify connectors are secure and reinforced with tie bands and/or tape. 9. V erify stopcocks and extension tubing are closed to prevent leakage and are secure from accidental breakage. 10. I nspect the PLU Disposable and connectors for evidence of cracking caused by inadvertent trauma. 11. Inspect gas tubing for proper connection to the Console and evidence of occlusion that may restrict gas flow. 12. Inspect for changes in blood flow and consider measuring transmembrane pressure. 9.1.3 GAS TRANSFER RATE The gas transfer of the oxygen into the blood should be measured on a periodic basis to monitor changes in the membrane. This can be performed by taking blood gas measurements pre and post oxygenator and calculating the gas transfer rate for a given blood flow rate. Significant changes in the gas transfer rate require additional evaluation. This should also include changes in the patient’s arterial and venous blood gas levels. 1. V  erify gas tubing between the Console and external source gas, and tubing between the console and the PLU Disposable are firmly attached to the console (T1&T2) 2. S  igh the oxygenator membrane on a periodic basis. Excess condensation can reduce gas transfer. 3. Monitor pre and post oxygenator blood gases for changes in performance. 4. Confirm the gas delivery and set points are as expected. 5. V  isually inspect the condensation trap by removing from the Pump Driver and replace as needed. 9.1.4 OXY-1 SYSTEM Routinely confirm that the OXY-1 System operating at the set points for blood flow and sweep gas flow rate and that the patient is responding to the therapy. 1. C  onfirm set points are as expected. Consider locking screen to prevent inadvertent changes to set parameters. 2. Monitor for the presence of alarms and troubleshoot as needed. 3. V erify the OXY-1 System is always plugged into an AC outlet to maintain optimal battery charge. 4. Verify the OXY-1 System is positioned and unobstructed for monitoring and access. 5. Verify the E-Drive is near, unobstructed, and accessible in the event of an emergency. 6. Verify the wheel casters are locked to prevent movement.

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9.2 SIGHING FUNCTION WARNING! • Hypocarbia (hypocapnia) is a state of reduced carbon dioxide in the blood. This may occur when sweep gas flow is set too high or if sighing is performed too often or for too long a duration. NOTE • Periodic Sighing prevents disruptions in oxygenation and CO2 removal due to condensation build-up Water vapor can condense in the membrane oxygenator, reducing gas permeability and resulting in poor oxygenation and CO2 clearance. It may be cleared by periodically increasing sweep gas flow to a high flow to force vapor out of the membrane. Sighing should be performed at regular intervals. One of two sighing methods is required based on the gas mode source: External or Internal. External Gas: When in External (wall/tank) gas mode, increase the sweep gas flow by manually increasing the flow rate via the control valve at the wall gas or tank output. The duration and level of increased sweep gas flow is determined by the Operator. Internal Gas: Internal gas sighing is a function of the Console and controlled by the Operator via the User Interface. 1. Initiate Sighing by touching the Sigh icon. 2. S  witch the function to the ON state. When enabled, the Sigh icon color will change from white to orange and the background will show a white progress bar. 3. T he Sighing function may be terminated at any time during the 2 minutes by touching the Sigh icon and switching the function to the OFF state.

USER INTERFACE INDICATION

SIGHING PROGRESS Indicates normal therapeutic delivery. Press to initiate the Sighing process. Indicates that sighing is selected and ready to initiate. Sighing process started. Indicates that the sighing process is starting. Sighing is about 75% complete. Sighing is complete.

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9.3 PLU DISPOSABLE CHANGE-OUT PROCEDURE

WARNING! • Pump left running with tubing clamped can lead to hemolysis and therapeutic disruption. • Inspect circuit for bubbles before initiating therapy

CAUTION! • Clamping tubes too tightly can cause tears and leaks in circuit.

In the event of oxygenator membrane failure, change out the PLU Disposable with the following procedure. See Troubleshooting table for more details.

1. Set up all necessary equipment to change out PLU Disposable:

a.

Sterile drapes and sterile scissors

b.

Minimum of 6 tubing clamps

c.

Disinfectant solution and applicators

d.

N  ew, primed PLU Disposable with blood tubing cut to desired length and

clamped

e.

Large syringe with saline solution for de-airing connector interface

f.

3/8” sterile hose barb connectors

2. Install 3/8” hose barbs into replacement PLU Disposable blood tubes.

3. Position replacement PLU Disposable adjacent to the PLU Disposable being changed.

4. U se aseptic technique to create a sterile field and disinfect blood tube surfaces that will be cut for implantation of the replacement PLU Disposable.

5. C  lamp Return and Drainage blood lines on both sides of the tube transected locations. Set Pump RPM to 0.

6. Cut blood tube between each pair of clamps.

7. D e-air and connect replacement PLU Disposable with corresponding patient line. Verify the correct line matches the corresponding blood flow direction.

8. Repeat steps 6 & 7 for other set of blood tubing.

9. R emove failed PLU Disposable from Pump Driver and insert replacement PLU Disposable.

10. Remove Cable Guard.

11. U nclamp blood tubing and increase pump speed to return blood flow to desired set point.

12. Inspect for presence of air bubbles as flow is restored.

13. A t Console, change out failed PLU Disposable gas tubing with replacement PLU Disposable gas tubing.

14. Verify sweep gas flow is restored to the PLU Disposable.

15. Reattach Cable Guard.

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