HEMOLUNG RAS Reference Guide Setup and Priming with Pre-Connected Tubing Quick Guide

12 Fill the Cartridge

13 Remove Air

14 Close the White Clamp

15 Open Blue Clamp and Remove Air

16 Check System for Air

17 Apply Petroleum Jelly, Install Cartridge and Tubing

18 Assemble the Vacuum Canister

19 Cap Ports and Place Canister

20 Connect Tube to Port

22 Connect Sweep Gas Supply Tube

23 Check Tubing Connections and Check for Air

25 Allow System to Self-Test

26 Successful Completion

21 Install Tube in Purge Valve and Connect to Canister

24 Start Recirculation

27 Select Sweep Gas Source

28 No Immediate Action Required on Controller

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Reference Guide Setup and Priming Before Setup, collect the following supplies: • One 500 mL or 1000 mL bag/bottle of priming solution (0.9% NaCl with 1 U/mL heparin added) • One 500 mL or 1000 mL bag of normal saline for seal flush To begin: 1 Remove Old Soda Lime • Plug in Controller • Turn power switch ON • Press Continue to set up New Circuit (press Recover to resume therapy) Prime Circuit following these steps: 2 Assemble and Attach New Soda Lime Column

3 Hang the Saline for Seal Flush

4 Set up Seal Flush

5 Connect IV Administration Set to Cartridge

6 Prepare Priming Solution

7 Hang Recirculation Bag

8 Connect Red Tube to Cartridge

9 Spike the Priming Solution

10 Connect Short Blue Tube to Recirculation Bag

11 Connect Blue Tube to Cartridge

12 Fill the Drip Chamber

13 Close Blue Slide Clamps on Recirculation Bag

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14 Prime the Cartridge

17 Close Blue Clamp on Priming Spike

20 Apply Petroleum Jelly, Install Cartridge and Tubing

23 Connect Vacuum Canister to Controller

26 Check Tubing Connections and Check for Air

29 Successful Completion

15 Use Gravity to Fill Cartridge

18 Open Blue Clamp on Recirculation Bag

21 Assemble the Vacuum Canister

24 Install Silicone Tube in Purge Valve and Connect to Vacuum Canister

27 Start Recirculation

30 Select Sweep Gas Source

16 Fill the Cartridge

19 Check System for Air

22 Close Unused Ports and Attach Vacuum Tubing

25 Connect Sweep Gas Supply Tube

28 Allow System to Self-Test

31 No Immediate Action Required on Controller

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Reference Guide Managing Therapy and Alarms Starting Therapy Prior to therapy, connect tubing to Catheter and start blood pump following these steps: 1 Close All Clamps

2 Connect TO PATIENT (Red) Tubing Set to Catheter

3 Connect FROM PATIENT (Blue) Tubing Set to Catheter

4 Press the Start Therapy Function Key to enter Therapy Mode

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Ensure the following: • No Air in the Circuit • Seal Flush Flow Rate of 30 mL/hr • All Clamps are Open

5 Press and hold the Pump Start/Stop key to initiate therapy Managing Therapy Address the following areas during Initial Therapy:

Audible Alarm key

Controlling Sweep Gas Flow Adjust sweep gas flow with upper set of Arrow Keys. It can be set to 0 L/min, or between 1.0 and 10.0 L/min in increments of 0.1 L/min.

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CAUTION: Set Sweep Gas to lowest setting that provides adequate carbon dioxide removal. High Sweep Gas setting can cause patient heat loss. Monitor patient temp during Hemolung therapy.

Controlling Pump Speed Adjust pump speed with lower set of Arrow Keys. It can be set between 500 and 1400 RPM in increments of 10 RPM.

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Sweep Gas Flow

Higher pump speeds will not always generate higher blood flow. Catheter can lodge against vessel wall due to negative pressure. Set pump speed to lowest setting that provides desired blood flow.

Pump Speed

Pump Start/Stop key

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Monitor during initial therapy: • Hemolung RAS CO2 Removal • Ventilator Status • Arterial Blood Gasses

Providing Supplemental O2 - If recommended by the physician, the Hemolung RAS can provide supplemental oxygenation to the patient through the use of oxygen as the sweep gas. See Change Sweep Gas for details. Operation During Purge - During Therapy, the Controller automatically enters a purge cycle every 15 minutes. This removes moisture from the fiber membrane and temporarily makes the pump louder. During the cycle “CO2 Removal” is temporarily displayed on screen as “---” and cannot be adjusted. HL-PL-0226_RB

Routine Tasks Daily Vacuum Canister Replacement - To replace follow these steps: 1 Assemble New Vacuum Canister 2 Close Unused Ports and Attach Vacuum Tubing

3 Attach Sweep Gas Elbow

Routinely inspect the entire circuit - Including the Hemolung Cartridge, Catheter, and blood tubing, for signs of failure such as: • Blood leaking from the circuit • Bubbles in the blood • Blood leaking into the sweep gas • Excessive vibration • Damage to the sweep gas circuit • Thrombus formation If any above conditions are found, replace at the discretion of the physician. Change Sweep Gas - To change the sweep gas while in Therapy mode follow these steps: 1 Press the Sub Menu Function Key followed by the Settings Function Key. 2 Use either set of Arrow Keys to select the desired sweep gas. 3 Connect or disconnect oxygen to the Hemolung RAS, depending on the sweep gas selected. 4 Press the Main Menu Function Key to return to the main Therapy screen. Change Seal Flush Fluid - Replenish seal flush fluid according to hospital procedures using normal saline. Refer to the Setup and Priming reference guide for instructions on setting up the seal flush. Catheter Maintenance and insertion site care is recommended per your institutional protocol. Acceptable cleaning solutions and disinfectants include: CAUTION: Do not use acetone or • Aqueous based povidone iodine (Betadine®) alcohol on any part of the Catheter ! tubing. These liquids may damage • Aqueous chlorhexidine topical solutions (ChloraPrep®) ® the Catheter. • Chlorhexidine patches (Biopatch ) ® • Chlorhexidine Gluconate (Hibiclens ) • Bacitracin and Neosporin® Ointments Alarms

WARNING: If pump is stopped during

Alarm Levels - Highest priority alarms are always indicated by audible and Do Not restart and continue ! therapy, therapy without a COMPLETE visual indicators and have precedence over any other alarm type. During evaluation of the patient and Hemolung RAS. multiple alarms, only the highest priority ones appear in the notification area. Active alarms can be viewed by pressing the Show Help Function Key. First Check: High Priority - In some cases the pump stops to prevent harm to the patient. Medium Priority - Pump continues to run but a prompt response is required to prevent diminished performance. Low Priority - Pump continues to run but system is operating in an unexpected state. Critical Errors - Condition that renders equipment unusable. After correcting error, power cycle system to clear.

• Patient’s condition and anticoagulation status • Length of time pump has been stopped • Any signs of thrombus formation in system • Consider any institutional procedures for continuing therapy Failure to properly evaluate patient and system conditions before reinitiating therapy may result in thromboembolism.

Alarm Indicators - Descriptions are shown on screen, along with an audible tone and indicator light when an alarm is present. The following chart shows alarm types and user notifications: Alarm Priority High

(Pump Stops)

Visual Indication Red LED Flashes

Audible Indication 10 Repeating Beeps

On-Screen Red Notification

High

(Pump Runs)

Red LED Flashes

10 Repeating Beeps

Red Notification

Medium

(Pump Runs)

Yellow LED Flashes

3 Repeating Beeps

Yellow Notification

Low

(Pump Runs)

Yellow LED Solid On

None

Yellow Notification

Critical Error

(Pump Stops)

Red LED Flashes

10 Repeating Beeps

Message with Special Instructions

Silencing Audible Alarms - To pause or silence the audible notification from an alarm, press the Audible Alarm Key on the upper left side of the display. Pressing the key once will silence the audible alarm for 2 minutes. Pressing and holding the key will silence the alarm indefinitely. 2500 Jane Street, Suite 1 | Pittsburgh, PA 15203 USA | ph: +1 412-697-3370 | fax: +1 412-697-3376 | alung.com

Reference Guide Rinse Back Prior to rinse back, prepare all necessary supplies: • Sterile scissors • Irrigation syringe • 500 mL bag of saline • Disinfectant solution

• Hemolung Rinse Back Kit

To enter Rinse Back mode on the Controller: • First press the Sub Menu function key • Next press the End Therapy key • Then press Continue to begin the on screen instructions

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WARNING: Once rinse back is initiated, pump will stop and user cannot restart therapy without power cycling the Controller.

1 Close Blue Clamp and Spike Saline Bag

2 Hang the Saline Bag and Prime Drip Chamber

3 Clamp Blue Tubing and Lumen

4 Sterilize FROM PATIENT (Blue) Tubing

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5 Cut FROM PATIENT (Blue) Tubing

6 Connect FROM PATIENT (Blue) Tubing to IV Tube

7 Release Blue Clamps

8 Do not exceed 250 cc of saline for flush back

9 Once Blood is Returned, Close Blue Clamps

10 Clamp Red Tubing and Remove Catheter

11 Dispose of Catheter and blood circuit following hospital procedures for biological wastes.

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WARNING: If circuit thrombosis is suspected, do not rinse back blood to patient at conclusion of therapy or when replacing Cartridge.

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Reference Guide Cartridge Changeout Prior to changing the Hemolung Cartridge, prepare the following supplies: • Disinfectant Solution • Hemolung Cartridge Kit • Sterile Scissors • Hemolung Rinseback Kit • 500 mL bag of saline • 30 mL syringes • Barb to Barb Connectors

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If blood rinse back is desired prior to changing the Cartridge, follow the procedures for returning the patient’s blood in the Rinse Back reference guide. Blood should only be returned to the body if there are no signs of clotting or thrombosis.

Change Cartridge following these steps: 1 Prime Hemolung Cartridge - Assemble, prime, and recirculate a new Hemolung Cartridge (with new blood tubing). See Setup and Priming reference guide for instructions.

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If a second Hemolung Controller is not available for priming the new circuit, Step 1 will be delayed until after the existing blood circuit has been disconnected from the Catheter (Step 7). In this case, Catheter patency must be preserved while priming the new circuit. Barb to Luer connectors can be used to connect a continuous infusion lines to the catheter lumens to prevent clotting. If the Catheter needs to be locked, use the provided caps.

2 Prepare Syringes - Fill the 30 mL syringes with normal saline. They will be used to provide irrigation during tubing connections. 3 Disinfect Blood Tubes - Clean and disinfect a 30 cm (12 in) length of each blood tube, starting at the catheter barb connector and moving toward the Hemolung Cartridge. Use one of the following approved solutions: • Aqueous based povidone iodine (Betadine®) • Chlorhexidine Gluconate (Hibiclens®) • Aqueous chlorhexidine topical solutions (ChloraPrep®)

4 Reduce Pump Speed - Reduce the Hemolung Cartridge pump speed to approximately 500 RPM. 5 Stop Pump - Press and hold the Pump Start/Stop Key to stop the Hemolung Cartridge pump. Because stopping the blood flow increases the risk of clotting, the remaining steps should be completed as quickly as possible. HL-PL-0226_RB

6 Close All Four (4) Clamps 7 Cut Blue and Red Tubing - Cut the tubing between the tubing clamp and the Catheter barb in the area that was previously cleaned.

8 Insert Barb-Barb Connector - Attach the barb-barb connectors to the tubing remaining on the Catheter.

9 Connect New Cartridge - Using a wet-wet technique, connect the new Cartridge to the Catheter.

10 Start Pump - Press and hold the Pump Start/Stop Key to restart the Hemolung Cartridge pump and resume therapy.

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Ensure the following: • No Air in the Circuit • Seal Flush Flow Rate of 30 mL/hr • All Clamps are Open

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Reference Guide Priming the BodyGuard 323 Setting up the Body Guard 323 Color Vision™ Infusion Pump

1 Hang and spike the saline

bag, then slowly fill the drip chamber about 1/2 of the way full.

2 Plug in and power on the pump by holding down the ON/OFF button.

3 Open door and install line in pump from left to right. Make sure key is inserted correctly, then close door.

4 Press the Prime button, then immediately press Start. Enter 20 mL for priming volume, and press Start to begin.

5 Connect check valve to seal flush port on Cartridge, then connect IV administration set to check valve and press Start to begin.

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Concentration can be entered as 0.0 as it is not applicable to saline.

6 Enter 30 mL for Rate then press Start.

7 Enter actual volume of IV bag for Volume then

8 Review on-screen info then press Start.

9 Press Start when ready to begin.

press Start.

10 Infusion will start and rate will be displayed. Confirm green LED is blinking.

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Refer to the BodyGuard 323 Color Vision™ Manual for further instructions.

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Ensure pump is set to Continuous Program.

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Reference Guide Catheterization Prepare Catheter and Insertion Supplies: • Fill three(3) 20 mL syringes with 20 mL each of sterile saline for injection. • Fill one (1) 10 mL syringe with 3 mL of sterile saline for injection.

1 Insert stylet with Priming Adapter into Red Infusion

2 Unscrew stylet from the Red Priming Adapter and

3 Flush Red Infusion Lumen with 20 mL syringe.

4 Remove syringe and replace stylet into the Red

Lumen. Slide Priming Adapter completely over the barb connector.

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remove it from the Catheter.

Infusion Lumen.

Do not attempt to clamp Red Lumen when stylet is inserted.

5 Flush Blue Drainage Lumen with 20 mL syringe. Clamp Blue Drainage Lumen using attached slide clamp then remove syringe.

6 Prepare insertion site according to your institution’s protocol. Ensure proper sterile precautions are taken to prevent infections.

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• Always follow your standard clinical procedure for placment of large-bore central venous catheters. • Reference Seldinger Technique

Hemolung RAS Instructions i Reference for Use section 3 Anticoagulation. 7 Puncture Vessel • With a sterile scalpel blade, nick the skin over the target vessel. • Attach a 10 mL syringe to the introducer needle and insert the needle into the target vessel using appropriate imaging technology. Aspirate to ensure proper placement. • Remove syringe and place thumb over the end of the introducer needle to prevent blood loss or air embolism. • Once blood has been aspirated, slide the flexible “J” tip end of the guidewire back into the advancer so that only the tip of the guidewire is visible. • Insert the advancer’s distal end into the needle hub. • Advance the guidewire with a forward motion into and past the needle hub so that it reaches the target vessel. Insertion length depends on the patient’s size. Do not allow the guidewire to enter the right atrium. • Securely holding the guidewire, remove the needle.

8 Anticoagulate Patient • After guidewire is placed, anticoagulate the patient per doctor’s orders. 80 U/kg heparin bolus is suggested. Allow to circulate then insert Catheter. HL-PL-0226_RB

aPTT PROTOCOL

ACT PROTOCOL Initial bolus: 80 U/kg Initial maintenance drip: 18 U/kg/hr Target ACT: 150–180 sec

Initial bolus: 80 U/kg Initial maintenance drip: 18 U/kg/hr Target aPTT: 1.5 to 2.3 x baseline

ACT (sec)

Bolus

Infusion Titration

aPTT (sec)

Bolus

Infusion Titration

< 90

30 U/kg

Increase infusion by 4 U/kg/hr

< 1.2 x baseline

80 U/kg

Increase infusion by 4 U/kg/hr

90–100

15 U/kg

Increase infusion by 3 U/kg/hr

1.2 to 1.5 x baseline

40 U/kg

Increase infusion by 2 U/kg/hr

100–126

10 U/kg

Increase infusion by 2 U/kg/hr

1.5 to 2.3 x baseline

None

No change

126–150

5 U/kg

Increase infusion by 1 U/kg/hr

2.3 to 3 x baseline

None

Decrease infusion by 2 U/kg/hr

151–180

None

No change

> 3 x baseline

None

181–200

None

Decrease infusion by 1 U/kg/hr

Interrupt infusion for 1 hr, then decrease infusion by 3 U/kg/hr

9 Dilate vessel using serial dilators

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• Slide vessel dilator onto the guidewire then advance it through the skin and into the vessel. Use a shallow angle approach to reduce the potential risk of guidewire kinks or a vessel puncture. • Next, remove dilator, leaving the guidewire in place.

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Use a shallow insertion angle to avoid guidewire kinking

CAUTION: Inserting the dilator at a different angle than the guidewire could result in guidewire kinking in the subcutaneous tissue.

10 Insert Catheter • Feed distal section of the stylet over the guidewire. Proper Catheter location will be indicated by free blood flow. Verify advancement, positioning, and placement of the Catheter using appropriate imaging guidance. • For JUGULAR insertion, advance Catheter tip to the junction of the superior vena cava and right atrium. • For FEMORAL insertion, advance Catheter tip into the inferior vena cava. • After Catheter placement verification, withdraw guidewire from stylet. Remove stylet from the Catheter by unscrewing it from the priming adaptor and withdrawing.

11 Check Catheter Patency and Remove Any Air • Attach 10 mL syringe filled with 3 mL sterile saline to priming adaptor of each Catheter lumen. • Release clamp and aspirate blood through each lumen. Blood should aspirate easily through both lumens. If either lumen exhibits excessive resistance to blood aspiration, rotate or reposition Catheter to obtain adequate blood flow.

12 Irrigate Both Lumens Using a Quick Bolus Technique • Open clamps to irrigate lumens with saline-filled 20 mL syringes. Then clamp both lumens after flushing. • Remove priming adapters before immediately connecting the blood tubing. Then unclamp lumens and blood tubing to start extracorporeal blood flow.

delay occurs in establishing extracorporeal blood flow, the Catheter lumens should be flushed i Ifcontinuously with a saline infusion to prevent clotting. It is not recommended to heparin lock the lumens. Femoral Catheter Securement • Secure Catheter hub to the skin using a strong suture that sits in the groove of the Catheter hub and is securely tightened. • Place lumens in the Grip-Lok device and secure it to the skin per the Grip-Lok IFU.

devices are provided in Catheter i Grip-Lok kits. Refer to Grip-Lok IFU for Instructions.

GRIP-LOK SUTURE GROOVE

FEMORAL

Jugular Catheter Securement • Place Catheter body in Grip-Lok device at the point where it exits the skin. Secure Grip-Lok to skin. • Secure Catheter hub to skin using a strong suture that sits in the groove of the Catheter hub and is securely tightened.

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JUGULAR

SUTURE GROOVE GRIP-LOK

Jugular Catheters must be secured at both the exit site and Catheter hub for maximum stability. 2500 Jane Street, Suite 1 | Pittsburgh, PA 15203 USA | ph: +1 412-697-3370 | fax: +1 412-697-3376 | alung.com