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ALUNG HEMOLUNG RAS Training Workbook

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HEMOLUNG
RAS
®
Training Workbook
80400
Pioneered by
HL-PL-0036_RH

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Summary of Contents for ALUNG HEMOLUNG RAS

  • Page 1 HEMOLUNG ® Training Workbook 80400 Pioneered by HL-PL-0036_RH...

  • Page 2: 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...

  • Page 3: Introduction

    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.

  • Page 4: Theory Of Operation

    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.
  • Page 5 Microscopic Microscopic View View of a Fiber of a Fiber BLOOD GAS EXCHANGE MEMBRANE BLOOD INLET SWEEP GAS INLET BLOOD OUTLET SWEEP GAS OUTLET INTEGRATED CENTRIFUGAL PUMP Page...

  • Page 6: Hemolung Ras Components

    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...
  • Page 7 Cartridge Blood Inlet (BLUE) Sweep Gas Inlet Seal Flush Port with Sweep Gas OneWay Outlet Valve Blood Outlet (RED) Catheters Stylet Infusion Lumen (RED) Suture Groove Infusion Drainage Drainage Lumen (BLUE) Port Port Infusion Lumen (RED) Suture Groove Drainage Lumen (BLUE) Drainage Port Infusion...
  • Page 8 Hemolung Cartridge Kit Contents Product Description Hemolung Cartridge Kit - SM IV Pump Configuration Contains all subsequent equipment used to set up therapy Hemolung Cartridge Kit - CME IV Pump Configuration Contains all subsequent equipment used to set up therapy Hemolung Cartridge Membrane oxygenator with integrated centrifugal pump Hemolung Accessories Kit - SM IV...
  • Page 9 (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 Product Description Hemolung Controller The reusable part of the Hemolung RAS. This self-contained unit holds all electronics and monitoring sensors. Page...
  • Page 10 Blood Flow Sensor Controller Bubble Detector Magnetic Drive Soda Lime Column Diagnostic Port Purge Valve Display Port Vacuum Canister Bracket Controller Power Switch Inlet Port AC Power Vacuum Inlet Canister Port Grounding Sweep Gas Port to Port Hemolung Cartridge Hemolung Controller Display Alarm LED AC Power Audible...
  • Page 11 User Interface Display Symbol Area Alarm Notification and Therapy Mode Area Main Area Navigation Area Therapy Mode Interface Removal Rate Trending Graph Measured Sweep Gas Flow Rate Desired/Set Sweep Gas Flow Rate Measured Removal Rate Measured Pump Speed Measured Blood Flow Rate Blood Flow Trending Graph Desired/Set Pump Speed...

  • Page 12: Preparation Of The Hemolung Ras

    4 Preparation of the Hemolung RAS The preparation of the Hemolung RAS includes 4 main parts: Part 1 Circuit Priming Part 2 Catheter Insertion Part 3 Connect Tubing to Catheter Part 4 Start Blood Pump The following supplies are required for circuit preparation: •...

  • Page 13: Part 1 Circuit Priming

    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...
  • Page 14 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.
  • Page 15 (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.
  • Page 16 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.
  • Page 17 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.
  • Page 18 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.
  • Page 19 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.
  • Page 20 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...
  • Page 21 Step 24 Check Tubing Connections and Check for Air Check all tubing connections. Inspect the entire circuit for signs of fluid leakage. If a leak is found, do not use the device. Check the circuit for air bubbles. Small air bubbles can be removed during recirculation.
  • Page 22 Step 27 Allow the System to Self-Test If an error is found in the system during recirculation, the pump will stop, a red ‘X’ will be displayed next to the failed check, and the screen will display possible courses of action to correct the problem.
  • Page 23 Step 30 No Immediate Action Required on Controller Once the Catheter Connection screen is entered, the pump will run continuously until ready for patient connection. Pressing the Next Function Key will stop the pump and display instructions and graphics for connecting to the patient.
  • Page 24 Priming with Separated Tubing If Priming Separate Packaged Components Use the up and down arrows to select the top disposable set, then press the Next button. 24 | Page...
  • Page 25 Step 1 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. Step 2 Assemble and Attach New Soda Lime Column Remove the red shipping plugs from the new column.
  • Page 26 Step 3 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.
  • Page 27 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 milliliter (mL) saline is recommended as the priming solution. Step 7 Hang Recirculation Bag Hang the empty recirculation bag, which is connected to the TO PATIENT (RED) Tubing Set, on the...
  • Page 28 All tubing connections must be placed over at least 2 barbs on connectors to prevent leaks. Step 9 Spike the Priming Solution Close the solid blue clamp located near the priming spike on the FROM PATIENT (BLUE) Tubing Set and spike the priming solution container.
  • Page 29 Step 12 Fill the Drip Chamber Squeeze the drip chamber and fill until it is at least half full. Step 13 Close Blue Slide Clamp on Recirculation Bag Close the blue slide clamp on the recirculation bag by sliding it over the tubing. Step 14 Prime the Hemolung Cartridge Hold the Hemolung Cartridge upside-down...
  • Page 30 Step 15 Use Gravity to Fill Cartridge Gravity will allow saline to fill the Cartridge. Keep the Cartridge below the recirculation bag level at all times. Step 16 Fill the Hemolung Cartridge (Continued) As the Hemolung Cartridge fills with priming solution, gently tap it to remove any trapped air bubbles.
  • Page 31 Step 18 Open Blue Clamp on Recirculation Bag Open the blue slide clamp on the recirculation bag. Guide any residual air bubbles found in the Hemolung Cartridge up the blue tube and into the recirculation bag. Step 19 Check System for Air Visually inspect the entire circuit for air bubbles.
  • Page 32 Step 21 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.
  • Page 33 Step 24 Install Silicone Tube in Purge Valve and Connect to Vacuum Canister Install the silicone sweep gas tube coming from the Hemolung Cartridge in the purge valve by pulling it upwards into the valve. Connect the elbow on the end of the tube to the vacuum canister port labeled “PATIENT”.
  • Page 34 Step 27 Start Recirculation Press the Continue Function Key to start the recirculation process, the pump will start automatically. The user is responsible for ensuring that no air bubbles are left in the circuit before continuing. Step 28 Allow the System to Self-Test If an error is found in the system during Recirculation,...
  • Page 35 Step 30 Select Sweep Gas Source Upon entering the Settings screen the pump will automatically restart. Use the Arrow Keys to select the desired sweep gas source. Press the Continue Function Key to accept changes and to proceed to the Catheter insertion instructions.

  • Page 36: Part 2 Catheter Insertion

    Part 2 Catheter Insertion Step 1 Prepare Syringes and Insert Stylet with Priming Adapter into Infusion Lumen (Red) Open the Hemolung Catheter Kit and prepare three 20 mL and one 10 mL saline syringe flushes. Using sterile technique, insert the stylet with RED priming adapter into the Infusion Lumen (RED), placing the priming adapter over the barb connector.
  • Page 37 Step 4 Reinsert Stylet Remove the syringe and replace the stylet into the Infusion Lumen (RED). Step 5 Flush Drainage Lumen (Blue) Connect one of the 20 mL syringes to the Drainage Lumen (BLUE) priming adapter. Hold the Catheter with the tip up and flush the Drainage Lumen (BLUE) with approximately 10 mL of saline.
  • Page 38 Step 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 a shallow angle (more parallel to the target vessel than a standard 45° approach).
  • Page 39 Prior to connection to the Hemolung RAS, a target ACT >150 seconds or aPTT > 1.5 times baseline is recommended. If a significant delay occurs between administering the heparin bolus and starting Hemolung therapy, verify the anticoagulation level and re-bolus as necessary.
  • Page 40 Step 9 Dilate Vessel Slide the dilator onto the guidewire advancing it through the skin and into the vessel using the same original insertion angle as the guidewire. Using the same shallow angle approach could reduce the potential risk of guidewire kinks or that a vessel is punctured.
  • Page 41 6. Ensure adequate tissue relaxation with each dilation step. Consider repeatedly inserting/retreating the dilator at each step until the tissue is fully relaxed and resistance to insertion is minimal. Utilize rotational motion to gently advance the dilators through the tissue. Incorrect: Dilator inserted at a different angle than the guidewire resulting in kinking in the subcutaneous tissue.
  • Page 42 Step 10 Insert Catheter Feed the distal section of the stylet over the guidewire. Proper Catheter location will be indicated by free blood flow. Verify the advancement, positioning, and placement of the Catheter using appropriate imaging guidance. For JUGULAR insertion, advance the Catheter tip to the junction of the superior vena cava and right atrium.
  • Page 43 If a delay occurs in establishing extracorporeal blood flow, the Catheter lumens should be flushed continuously with an appropriate intravenous solution to prevent clotting. Step 13 Secure Catheter Femoral Catheter Secure the Catheter hub to the skin using a strong suture. The suture should be placed in the groove of the Catheter hub...

  • Page 44: Part 3 Connect Tubing To Catheter

    Part 3 Connect Tubing to Catheter Step 1 Close All Clamps Press the Next Function Key to proceed to Blood Tubing Connection. Close all clamps in the circuit. The plastic sheath surrounding the blood tubing is provided for sterile handling. Take extra care handling the blood tubing area surrounding the Catheter connection.

  • Page 45: Part 4 Start Blood Pump

    Part 4 Start Blood Pump After connecting the primed extracorporeal circuit to the Catheter, Therapy is initiated by pressing Start Therapy Function Key, which causes blood to flow through the extracorporeal circuit and sweep gas to pass through the Cartridge membranes. The Hemolung Cartridge will initially operate at the default pump speed (500 RPM) and sweep gas flow rate (1 L/min).

  • Page 46: Managing Therapy And Using The Ras

    5 Managing Therapy and Using the RAS When determining initial sweep gas flow settings, one should take into account that CO removal when starting Therapy is nearly instantaneous. The impact to the patient varies based on pCO level and patient status. Raising the sweep gas flow setting too quickly could result in the patient becoming hypocapnic.

  • Page 47: Controlling Sweep Gas Flow

    Controlling Sweep Gas Flow Increasing the sweep gas flow rate will increase CO removal. The sweep gas flow rate can be set to 0 L/min, or be adjusted between 1.0 and 10.0 L/ min. The sweep gas flow rate can only be changed from the Main Menu. To adjust the sweep gas flow rate: Use the upper set of Arrow Keys to increase or decrease the flow rate in increments of 0.1 L/min.
  • Page 48 Status The right side shows a list of all active alarms. The left side shows technical information about the system that can be used during troubleshooting or servicing. Settings After Priming and Recirculation have been completed, you will be prompted for the Sweep Gas selection.

  • Page 49: Daily Vacuum Canister Replacement

    Daily Vacuum Canister Replacement The sweep gas vacuum canister must be changed daily to ensure adequate sweep gas flow. No changes or operations to the therapy parameters or blood pump are necessary to complete this task. An alarm will temporarily appear on the display screen during and following the vacuum canister change and should clear within approximately 1 minute.

  • Page 50: Change Sweep Gas

    However, oxygen should be used if supplemental oxygenation to the patient is desired. The purpose of selecting the sweep gas on the Hemolung RAS is to configure the alarms used to ensure proper system operation. Specifically, an alarm will be generated if supplemental oxygenation is desired, but the oxygen runs empty or is disconnected.

  • Page 51: Weaning & Ending Therapy

    6 Weaning & Ending Therapy Weaning from Therapy is done by progressively reducing the amount of CO removal while closely monitoring the patient. The sweep gas flow rate can be reduced to zero while circuit blood flow is maintained in order to evaluate the patient’s response to withdrawing Therapy.
  • Page 52 Step 2 Hang the saline bag on the Controller. Squeeze the plastic chamber to prime the IV tube. Step 3 Clamp the FROM PATIENT (BLUE) Tubing approximately 20 cm (8 in) from the Catheter connection using the attached ratchet clamp or another tubing clamp.
  • Page 53 Step 5 After ensuring that the clamps are closed, cut the FROM PATIENT (BLUE) Tubing between the tubing clamp and the Catheter barb connector in the area that was previously cleaned. Step 6 Using a wet-to-wet technique, connect the priming spike barb connector to the FROM PATIENT (BLUE) Tubing, ensuring no air is trapped in the tubing.
  • Page 54 Step 8 Once the blood is returned, clamp the FROM PATIENT (BLUE) Tubing and IV line using the attached ratchet clamps. Step 9 Close the TO PATIENT (RED) Tubing and remove the Catheter in the same manner as any other large bore central venous catheter.

  • Page 55: Without Blood Rinse Back

    Without Blood Rinse Back The attending physician may decide it is not necessary to return blood to the patient and discard the entire circuit. Step 1 Press and hold the Pump Start/Stop Key to stop the Hemolung Cartridge pump. Step 2 Clamp both Catheter lumens with the attached slide clamps.

  • Page 56: Troubleshooting

    7 Troubleshooting Management of Alarms Alarm notifications are prioritized by the device. The highest priority alarm is always indicated by the audible and visual indicators. High Priority alarms have precedence over any other type of alarm. When multiple alarms occur, only the alarms of the highest priority are displayed in the notification area.

  • Page 57: Critical Errors And Accidental Termination Of Therapy

    Critical Errors and Accidental Termination of Therapy If Therapy has been stopped due to a critical error, user error, battery depletion or other unforeseen circumstances, the user must turn the Controller off before the device can become operational. In these cases the Hemolung Controller can skip setup procedures and immediately enter therapy mode by pressing the Recover button on the Setup screen.
  • Page 58 Step 3 Read all warnings and press the Recover Function Key to start therapy. 58 | Page...

  • Page 59: Device Maintenance

    AC power failure. Do not remove the instrument covers on the Hemolung Controller. The Hemolung RAS does not have any user serviceable parts and the battery cannot be replaced by the user. Contact ALung or your medical equipment distributor for service or repairs.

  • Page 60: Storage

    Keep plugged into AC outlet at all times. Preventative Maintenance There are no user serviceable parts. The Hemolung Controller requires an annual calibration and safety check by a certified technician. Contact Information ALung Technologies, Inc. 2500 Jane Street Suite 1 Pittsburgh, PA 15203 USA +1-724-506-5149 +1-412-697-3376 Web www.alung.com...
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  • Page 66 Pioneered by ALung Technologies, Inc. 2500 Jane Street, Suite 1 Pittsburgh, PA 15203 USA tel: +1 724-506-5149 fax: +1 412-697-3376 email: sales@alung.com 80400 www.alung.com HL-PL-0036_RH...

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