HEMOLUNG CR4 Training Workbook

Table of Contents 1 Introduction... 3 2 Theory of Operation...4 3 Hemolung RAS Components...6 4 Preparation of the Hemolung RAS... 12 Part 1 Circuit Priming... 13 Part 2 Catheter Insertion...36 Part 3 Connect Tubing to Catheter... 44 Part 4 Start Blood Pump...45 5 Managing Therapy and Using the RAS... 46 Controlling Pump Speed... 46 Controlling Sweep Gas Flow...47 Menu Screens...47 Daily Vacuum Canister Replacement... 49 Change Sweep Gas... 50 Change Seal Flush Fluid... 50 6 Weaning & Ending Therapy... 51 Blood Rinse Back... 51 Without Blood Rinse Back...55 7 Troubleshooting...56 Management of Alarms...56 Critical Errors and Accidental Termination of Therapy...57 8 Device Maintenance...59 Battery...59 Cleaning...59 Storage... 60 Preventative Maintenance... 60 Contact Information... 60

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1 Introduction The Hemolung Respiratory Assist System (RAS) is an integrated, single-use gas exchange system designed to provide partial extracorporeal respiratory support. Oxygen is supplied and carbon dioxide is removed from blood circulated through the Hemolung RAS. The utilization period of this device is validated for up to seven days. The intended users of the system are advanced health care providers with experience in critical care hospital settings, including registered nurses and physicians. The Hemolung RAS Training Workbook contains extracts from the Instruction for Use (IFU). The Training Workbook is a training support tool that does not contain safety and warning advice. It is intended as a quick reference guide and does not replace clinical training for the Hemolung RAS. The Workbook is not intended to be exhaustive. In case of doubt the legal reference is always the Instruction for Use.

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2 Theory of Operation The Hemolung RAS is an integrated, single-use gas exchange system that provides partial extracorporeal respiratory support by providing gas exchange independently of the lungs. Oxygen is supplied and carbon dioxide is removed from blood circulated through the system. This gives the patient’s lungs time to rest and heal. Control of CO2 removal is dependent on three fundamental factors. These are: • • •

Patient pCO2 Sweep Gas Flow Rate Blood Flow Rate (determined by motor RPM)

CO2 removal is achieved by running the selected sweep gas (oxygen or room air) through the center of the hollow fibers in the Cartridge while blood is circulated around the outside of the fibers. The sweep gas flow is determined by the programmed Sweep Gas Flow Rate and the Blood Flow Rate is determined by the pump speed. The difference in CO2 concentration between the patient’s blood (high) and the sweep gas (low) causes CO2 to diffuse from the blood, across the membrane, and into the sweep gas. The CO2 is then exhausted from the Hemolung Cartridge.

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Microscopic Microscopic View View of a Fiber of a Fiber

BLOOD O2

CO2

GAS EXCHANGE MEMBRANE BLOOD INLET SWEEP GAS INLET

O2 IN

CO2 OUT

BLOOD OUTLET

SWEEP GAS OUTLET INTEGRATED CENTRIFUGAL PUMP

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3 Hemolung RAS Components The Hemolung RAS is comprised of 3 main components. Hemolung Cartridge • Membrane oxygenator with integrated centrifugal pump

Hemolung Catheter • 15.5 Fr dual lumen venous Catheter with insertion accessories, percutaneous, single-stick venous access, femoral (26cm) and jugular (17cm) available Hemolung Controller • Controls the Cartridge pump speed and gas flow while providing realtime monitoring of CO2 removal and blood flow, bubble detection and other operating alarms • Infusion pump: continuous saline infusion to prevent bearing damage Always check the expiration date prior to use. Do not use the disposable if it is expired. See Section 2 in the Instructions for Use for more Detail. | Page 6 |

Cartridge

Blood Inlet (BLUE) Sweep Gas Inlet

Seal Flush Port with OneWay Valve

Sweep Gas Outlet

Blood Outlet (RED)

Catheters

Stylet Infusion Lumen (RED) Suture Groove

Drainage Lumen (BLUE)

Infusion Port

Drainage Port

Infusion Lumen (RED) Suture Groove

Drainage Lumen (BLUE) Infusion Port

Drainage Port

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Hemolung Cartridge Kit Contents Ref

Product Description

12000

Hemolung Cartridge Kit - SM IV Pump Configuration Contains all subsequent equipment used to set up therapy

13000

Hemolung Cartridge Kit - CME IV Pump Configuration Contains all subsequent equipment used to set up therapy

10002

Hemolung Cartridge Membrane oxygenator with integrated centrifugal pump

12100

Hemolung Accessories Kit - SM IV Contains the following equipment to set up or stop therapy: Hemolung Rinse Back Kit Soda Lime Column SM IV Administration Sets Vaseline Jelly (7) 1500 mL Vacuum Canisters

13100

Hemolung Accessories Kit - CME IV Contains the following equipment to set up or stop therapy: Hemolung Rinse Back Kit Soda Lime Column IV Administration Sets Vaseline Jelly (7) 1500 mL Vacuum Canisters

80101

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Hemolung Cartridge Kit IFU Printed Instructions for Use

Hemolung Catheter Kit Contents Ref

Product Description

30020

Hemolung 15.5 Fr Femoral Catheter Kit (1) 15.5 Fr Femoral Catheter with Stylet (2) Grip-Lok™ Wide Adhesive Universal Catheter Securement (5) 6, 9, 12, 14, & 16 Fr Dilator (1 of each) (1) 10 mL Syringe (1) #11 Scalpel (1) 18 Ga x 7 cm (2.75 in) Introducer Needle (1) 0.038 in x 100 cm Guidewire with Straightener and J-Tip 30120

Hemolung 15.5 Fr Jugular Catheter Kit (1) 15.5 Fr Jugular Catheter with Stylet (2) Grip-Lok™ Wide Adhesive Universal Catheter Securement (5) 6, 9, 12, 14, & 16 Fr Dilator (1 of each) (1) 10 mL Syringe (1) #11 Scalpel (1) 18 Ga x 7 cm (2.75 in) Introducer Needle (1) 0.038 in x 100 cm Guidewire with Straightener and J-Tip

Hemolung Controller Ref

Product Description

20000

Hemolung Controller The reusable part of the Hemolung RAS. This selfcontained unit holds all electronics and monitoring sensors.

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Controller

Blood Flow Sensor Bubble Detector Magnetic Drive Soda Lime Column

Diagnostic Port

Purge Valve

Display Port Vacuum Canister Bracket Controller Power Switch

O2 Inlet Port AC Power Inlet

Vacuum Canister Port

Grounding Port

Sweep Gas Port to Hemolung Cartridge

Hemolung Controller Display Alarm LED Audible Alarm Key

AC Power LED

Pump Start/Stop Key

Arrow Keys

Function Keys

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User Interface

Display Symbol Area

Alarm Notification and Therapy Mode Area

Main Area

Navigation Area

Therapy Mode Interface CO2 Removal Rate Trending Graph

Measured CO2 Removal Rate

Measured Sweep Gas Flow Rate Desired/Set Sweep Gas Flow Rate

Measured Pump Speed Measured Blood Flow Rate

Blood Flow Trending Graph

Desired/Set Pump Speed

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4 Preparation of the Hemolung RAS The preparation of the Hemolung RAS includes 4 main parts: Part 1 Part 2 Part 3 Part 4

Circuit Priming Catheter Insertion Connect Tubing to Catheter Start Blood Pump The following supplies are required for circuit preparation: • One 500 mL or 1000 mL bag or bottle of priming solution. 0.9% NaCl (normal saline) with 1 U/mL heparin added is the recommended priming solution. • One 500 mL or 1000 mL bag of normal saline for seal flush.

To Begin Plug Controller into an AC outlet and turn on using the power switch located on the back of the Controller. During the POST (Power On Self Test) noise from the vacuum pump and Cartridge motor can be expected as they are tested. After successful completion the Setup screen will be displayed. • Press the Recover button to resume therapy if the patient is already catheterized and connected to the Cartridge. • Press the Language button to select the language. • Press the Continue button if you are setting up a new circuit. This will advance you to the Select Disposables Set screen.

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Part 1 Circuit Priming Step 1 Select Disposable Set Use the up and down arrows to select which disposable set you will be using, then press the Next button. If using the separate individually packaged components, select the top configuration. If using the pre-connected components within the sealed tray, select the bottom configuration.

Priming with Pre-Connected Tubing

Step 2 Remove Old Soda Lime Pull the old soda lime column out of the Controller and remove the reusable end caps. Discard the old soda lime column.

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Step 3 Assemble and Attach New Soda Lime Column Remove the red shipping plugs from the new column. Attach the reusable end caps to the column and install the new soda lime column on the Controller.

Step 4 Hang the Saline for Seal Flush Hang the container of saline for providing the seal flush on the Hemolung Controller. If necessary, adjust the height of the pole so that the bottom of the saline container is between 15cm and 30cm (between 6 and 12 inches) above the seal flush pump.

Step 5 Set up Seal Flush Prime the IV administration set for the Infusion Pump. Load the IV administration set into the pump. Refer to the Instructions for Use that accompany the IV administration set and infusion pump for these procedures. | Page 14 |

Step 6 Prepare Priming Solution Prepare a priming solution of at least 500 mL and hang on the Controller. One (1) unit (U) heparin per mililiter (mL) saline is recommended as the priming solution.

Other priming fluids have not been qualifed for use with the Hemolung RAS. Use only at the discretion of the prescribing physician.

Step 7 Open Disposables Remove the sterile cover from the tray. To remove the contents from the tray, begin by lifting the string at the top of the recirculation bag to unravel the tubing. Then remove the Cartridge from the tray last. The contents inside the tray are sterile until the lid is removed.

Step 8 Hang Recirculation Bag and Sit Cartridge on Controller Hang the recirculation bag by the attached string on the IV pole so that it is below the saline bags. Temporarily set the Cartridge on top of the Controller.

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Step 9 Connect Infusion Pump and Run at 30 mL/hr Remove the cap from the seal flush port on the Hemolung Cartridge and then attach the check valve to the port. Open the clamp on the IV administration set and start the seal flush infusion at 30 mL/ hr. Refer to the Instructions for Use that accompany the Infusion Pump for instructions on operating the pump. The seal flush port should not be used for drug infusion.

Step 10 Close White Clamp and Spike Saline Close the white clamp located near the priming spike on the blue tubing. Spike the priming solution with the spike line from the recirculation bag. The Hemolung Cartridge requires a continuous infusion of saline (0.45% to 0.9% NaCl) at a rate of 30 mL/hr to protect the Cartridge shaft seal. Insensible water loss occurs through the sweep gas of up to 20 mL/hr (depending on the sweep gas flow rate). These factors should be taken into account when managing a patient’s electrolyte and fluid balance.

Step 11 Close Blue Clamp on Recirculation Bag Close the blue clamp on the recirculation bag. | Page 16 |

Step 12 Prime the Cartridge Hold the Hemolung Cartridge upside-down with the red blood outlet port facing up. Open the white clamp located near the priming spike. This will start the flow of priming solution into the Hemolung circuit. Walk the air through the tubing until it is completely primed and solution begins to enter the Hemolung Cartridge.

Step 13 Fill the Cartridge Fill the Cartridge by keeping the red port up and the entire Cartridge below the saline bags.

Step 14 Remove Air With the Cartridge in the same position, tap the side to remove any trapped air. Prime the Cartridge with at least 500 mL of priming solution. | Page 17 |

Step 15 Close the White Clamp Once the Cartridge is full, close the white clamp.

Step 16 Open Blue Clamp and Remove Air Open the blue clamp to allow any trapped air to travel up and into the recirculation bag. Shake the line to assist in this process if needed.

Step 17 Check System for Air Visually inspect the entire circuit for air bubbles. If air bubbles are found in the circuit, guide them into the recirculation bag.

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Step 18 Apply Petroleum Jelly, Install Cartridge and Tubing Place the Cartridge on the Controller as shown. Apply a small amount of petroleum jelly to the area of the tubing that sits in the blood flow sensor. Place the tubing into the bubble detector and flow sensor, and close the flow sensor door. Do not place petroleum jelly on the section of tubing that is placed into the bubble detector.

Step 19 Assemble the Vacuum Canister Place the lid on top of the vacuum canister and apply pressure around the circumference of the lid to secure it. Several "clicks" will be heard when the canister lid is properly secured. Visually inspect the canister lid for proper securement. The vacuum canister lid must be firmly attached to the canister to form a vacuum. Failure to do so will result in a low sweep gas flow alarm.

Step 20 Cap Ports and Place Canister Cap the large port labeled "ACCESSORY" and the small port labeled "TANDEM". These ports will not be used. Hang the vacuum canister on the side of the Controller using the provided bracket. | Page 19 |

Step 21 Connect Tube to Port Connect the free end of the sweep gas vacuum tube to the vacuum canister port on the rear panel of the Controller.

Step 22 Install Tube in Purge Valve and Connect to Canister Install the silicone sweep gas tube coming from the Cartridge into the purge valve by pulling it upwards into the pinch valve. Connect the elbow on the end of the tube to the vacuum canister port labeled "PATIENT".

Step 23 Connect Sweep Gas Supply Tube Connect the sweep gas supply tube (with bacterial filter) to the sweep gas port on the Controller as shown.

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