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

On

Keep Dry

Read Instructions

Standby

Storage Humidity Range

Quantity

On/Standby Switch

Keep Away from Sunlight

Class II IEC

Manufacturer

Non-Pyrogenic

Mass

Date of Manufacture

Storage Temperature Range

Input

Unique Device Identifier

Do Not Use if Package is Damaged

Prescription Only

Catalog Number

Recycle: Electronic Equipment

Type CF

Lot Number

Water Ingress Rating

Use By

Serial Number

Sterilized Using Ethylene Oxide

Reserve Port 1

Reserve Port 2

Data Transfer

Oxygen Gas

Tubing Interface 1

Tubing Interface 2

Cable Interface 1

Fuse

Pole Mount Bracket Orientation

MET Certification Mark

Do Not Reuse

Lithium ion batteries contained in equipment

Warning

Caution

Package Orientation during Shipping

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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

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

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

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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 • • • •

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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 Full Range > 95% Saturation* TUBING 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 2.9 lbs. (1.3 kg) Disposable) 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 Flow rate < 15 LPM from external flow meter O2 barb tubing connector Internal Gas Mode: Oxygen: 0.5 – 3 LPM greater of ± 10% LPM or Sweep Gas (setting) ± 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 Battery Type Battery Run Time Battery Charge Time (from zero state)

5.0 A, 100-240 VAC, 50/60 Hz Lithium Ion 200 minutes (see Section 14) < 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

Disposable Gas port interface

External O2 Source 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. 16

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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

Upper and Lower Alarm Setting

Pump Control field Increase / Decrease Control Sweep gas status & control field

Sigh Function Icon

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O2 Concentrator Warm-up Icon

Lock Screen Icon

System Settings Screen

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OXY-1 System Parameters

Software Version

Battery Status

OXY-1 System Operator’s Manual

Delete Data

Return to Home Screen

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