3.2.3   Turning on the VitaSmart

  1. Insert a USB thumbdrive into the USB slot situated on the external monitor.

NOTE: In order to capture and save the data a USB thumbdrive MUST be inserted prior to turning on the VitaSmart.

  1. Turn on the VitaSmart by pushing the Main Power Switch to the “I” position

NOTE: Notify the Bridge to Life Service Department if the VitaSmart Pump Head emits an audible alarm (indicating a malfunction) or if the screen goes dark or becomes unreadable.

Fig 3.2.3

3.3   Main menu

NOTE: The Selector Knob both (a) progresses through the screens and (b) edits and confirms a field.

  1. Progress through the screens:
    • Rotate the Selector Knob left or right to highlight a field (YELLOW).
    • Press the Selector Knob to confirm.
    • If a CONFIRM field appears, highlight the field and press to make the confirmation.
  1. Edit a Field:
    • Rotate the Selector Knob left or right to highlight a field (YELLOW).
    • Press the Selector Knob to enable edits in a field (BLUE).
    • Rotate the Selector Knob left or right until desired value displays.
    • Press the Selector Knob again (YELLOW) to confirm the change.
  1. Advance to the Technical Parameters Highlight, select and change each field (below) as required with the Selector Knob.

Fig 3.3

NOTE: Values that can be changed are in white boxes, while those in gray boxes are informational values that cannot be changed.

  • Language: Enable activation of messages displayed in the selected language
  • Date: Sets the current date (DD/MMM/YYYY)
  • Time: Sets the current time
  • Display Contrast: Sets the brightness of the display (including values from 0 to 100)
  • Unlock code: For manufacturing use only

To exit the screen, select the Page Back field and confirm by pressing the Selector Knob.

6   Portal Vein and Artery Treatment – Liver

NOTE: The Portal Vein and Artery – Liver perfusion kit code is KOP03L2 contains:

  • A unique line for portal vein and artery – liver perfusion, code M90357, enclosed in a paper-film pouch
  • Radio Frequency Iddentification (RFID) card

6.1   Organ selection

  1. Use Selector Knob to select the Portal Vein and Artery – Liver The device will ask to confirm that the proper kit is used.

Fig 6.1

  1. Place the RFID card in the RFID card reader on the body of the VitaSmart machine. This operation prevents tube set exchange errors or use of unapproved tube sets. If the procedure and the tube set correspond, then the machine will proceed. Otherwise an error message appears.[INSERT ORGAN SELECTION & RFID CARD VIDEO]

Fig 6.1.2

NOTE: Every time the RFID is checked the following errors may occur:

  1. CHOSEN TAG NOT CORRECT: Means the opened tube set does not correspond to the selected treatment.
  2. TAG NOT PRESENT: Means that the TAG has not been inserted or cannot be read.
  3. TAG EXPIRED: The TAG and the corresponding tube set has already been used and must be disposed.
  1. If there are no errors, press CONFIRM.

Before carrying out the treatment, it is necessary to prime the whole circuit. This operation is carried out during the Priming phase.

During the Priming phase the VitaSmart will automatically carry out selfchecks of the Air sensor and Pressure sensors.

6.2   Mounting of the PORTAL VEIN and ARTERY – LIVER tube set

Fig 6.2

Portal Vein Tubing Set (1)

1A- Withdraw Port
1B- Withdraw Sample Port
1C- Withdraw Pressure Transducer Line
1D- Pump Segment Line connector (in)
1E- Pump Segment Line
1F- Pump Segment Line connector (out)
1G- Filter Bypass Line
1H- Pre-Filter Line
1I- Filter
1J- Post-Filter Line

1K- Oxygenator Bypass Line
1L- Pre-Oxygenator Line
1M- Post-Oxygenator Line
1N- Dampen chamber
1O- Dampen chamber Air Inlet
1P- Delivery Pressure Transducer Line
1Q- Delivery Line
1R- Delivery Sample Port
1S- Delivery Port

Hepatic Artery Tube Set (2)

2A- Withdraw Port
2B- Withdraw Sample Port
2C- Withdraw Pressure Transducer Line
2D- Pump Segment Line connector (In)
2E- Pump Segment Line
2F- Pump Segment Line connector (Out)
2G- Filter Bypass Line
2H- Pre-Filter Line
2I – Filter
2J- Post-Filter Line

2K- Oxygenator Bypass Line
2L- Pre-Oxygenator Line
2M- Post-Oxygenator Line
2N- Delivery Pressure Transducer Line
2O- Delivery Sample Port
2P- Delivery Line
2Q- Delivery Port

Oxygenator

T- Oxygenator Inflow
U- Oxygenator Outflow
V- Oxygen Inlet
W- Oxygen Supply Tubing

WARNING: Inspect each disposable package and the disposable tube set. If damaged, opened, or expired DO NOT USE and notify the Bridge to Life Service Department.

  1. There are two tube sets in the package. Remove Portal Vein – Liver Set (M90356) from the bag.
  2. Use the plastic support holder clamps to affix the external tubing support holder (located in the Portal Vein-Hepatic Artery Liver perfusion set) to the perfusion bowl.
  3. Insert the BLUE Withdrawal line with the conical filter on the tip (1A) into the bowl. Ensure the Withdrawal conical filter is fully submerged and free from occlusions. Ensure the tubing is secured using the external tubing support holder.
  4. Remove the cap from the RED Delivery Port (1S) and insert the tip into the bowl. Ensure tubing is secured using the external tubing support holder.
  5. Insert the Filter (1I) into the filter support.
  6. Insert the Dampening Chamber (1N) into Dampening Chamber holder. Ensure that the Delivery Line exits at the bottom.
  7. Keeping the Delivery line (1Q) taut, insert the Delivery line tubing into the Air Bubble Detector by pressing or sliding it into position.
  8. Connect the Delivery Pressure Transducer line (1P) identified with the RED transducer protector, to the RED Delivery Pressure Transducer connector on the VitaSmart front panel. Ensure the connection is straight on and the RED Luer cap is screwed on tight.
  9. Connect the Withdrawal Pressure Transducer line (1C), identified with the two BLUE transducer protectors, to the BLUE Withdrawal Pressure Connector 1 on the VitaSmart front panel. Ensure the connection is straight on and the BLUE Luer cap is screwed on tight.
  10. Open the Pump 1 (front pump) cover.
  11. Lift to release the Pump 1 rotor lever.
  12. Following the direction of the arrows on the Pump 1, start from the bottom and slowly insert the Pump Segment tube (1E) onto the rollers of Pump 1.
  13. Use the lever to turn the rotor counterclockwise. Ensure the tubing is positioned with the pump Segment Line Connectors (1D and 1F) outside the pump housing. The roller pump will feed the tube using the cradles.
  14. Manually rotate the rotor so that the piece fits comfortably inside the Pump 1 housing.
  15. Close the rotor lever, VERIFYING THAT the pump Segment Line Connectors remain outside the pump housing.
  16. Close the Pump 1 cover.
  17. Clip the Oxygenator into the Oxygenator Support
  18. Connect the pre-oxygenator line (1L, RED) to the oxygenator inflow line (T, RED) and the post-oxygenator line (1M, BLUE) to the oxygenator outflow line (U, BLUE).
  19. Connect the oxygen tube (V), to the dedicated oxygen inlet (W) of the oxygenator (GREEN to GREEN).
  20. Connect the other end of the oxygen tubing (V) to the oxygen source.
  21. Take the Hepatic Artery tube set (M90357) from the bag.
  22. Use the plastic support holder clamps to affix the external tubing support holder (located in the Hepatic Artery-Liver perfusion set) to the perfusion bowl.
  23. Insert the BLUE Withdrawal line with the conical filter on the tip (2A) into the bowl. Ensure the Withdrawal conical filter is fully submerged and free from occlusions. Ensure the tubing is secured using the external tubing support holder.
  24. Remove the cap from the RED Delivery Port (2Q) and insert the tip into the bowl. Ensure tubing is secured using the external tubing support holder.
  25. Insert the Filter(2I) into filter support
  26. Connect the Withdrawal Pressure Transducer line (2C), identified with the CLEAR transducer protector, to the CLEAR Withdrawal Pressure Connector 2 (20) on the VitaSmart side panel. Ensure the connection is straight on and the CLEAR Luer cap is screwed on tight.
    [INSERT WITHDRAWAL PRESSURE TRANSDUCER VIDEO]
  27. Open the Pump 2 (side pump) cover.
  28. Release the Pump 2 rotor lever.
  29. Use the lever to turn the rotor counterclockwise. Ensure the tubing is positioned with the pump Segment Line Connectors (1D and 1F) outside of the pump housing. The roller pump will feed the tubing using the cradles.
  30. Close the Pump 2 cover.
    [INSERT PUMP 2 SEGMENT LINE INSERTION VIDEO]
  31. Connect the Delivery Pressure Transducer line (2N) identifed with the GREEN Transducer filter to the GREEN Delivery Pressure Connector 2 on the VitaSmart Side panel. Ensure the connection is straight on and the GREEN Luer cap is screwed on tight.
    [INSERT DELIVERY PRESSURE TRANSDUCER VIDEO]
  32. Oxygenator (This second oxygenator is optional)
    32.1 If using the oxygenator, place the oxygenator into the oxygenator support.
    [INSERT OXYGENATOR PLACEMENT VIDEO]
  1. Connect the pre-oxygenator line (1L, RED) to the oxygenator inflow line (T, RED) and the post-oxygenator line (1M, BLUE) to the oxygenator outflow line (U, BLUE).
  2. Connect the oxygen tube (V), to the dedicated oxygen inlet (W) of the oxygenator (GREEN to GREEN).
  3. Connect the other end of the oxygen tubing (V) to the oxygen source.

32.2  If you do not use the oxygenator:

  1. Attach the RED pre-oxygenator line (1L) to the BLUE Post oxygenator line (1M) using the colorcoded connectors.
    [INSERT HEPATIC ARTERY TUBING SET VIDEO]

6.3   Priming Procedure

WARNING: During priming, the organ must NOT be connected

NOTE: If Priming needs to be paused before completion, use the button. If RESTART PRIME is selected, the whole priming process will need to be restarted.

  1. Make sure the circuit has been connected as described above.
  2. Use the plastic hemostat to occlude the Delivery line (1Q) after the Air Bubble Detector.
  3. Open all RED, BLUE, and WHITE clamps on both tubing sets.
    [INSERT HEPATIC ARTERY OPEN CLAMP PHOTOS]
  4. Remove the Luer caps from the top of both filters (1I & 2I).

  5. Remove the Luer cap from top of the Dampening Chamber (1N).

NOTE: Ensure Withdrawal port (1A) is fully submerged in Machine Perfusion Solution

  1. Select and confirm the Start Priming command to open the PRIMING screen.

Fig 6.3.6

  1. Use the Selector Knob to highlight the Flow Rate (ml/min).
  2. Press the Selector Knob so that the field turns from YELLOW to BLUE.
  3. Rotate the Selector Knob until you reach 100ml/min; Press to confirm (this will change the field from BLUE to YELLOW).
    [INSERT DUAL PUMP FLOW RATE SELECTION VIDEO]
  4. When the filter is primed press to stop the pump. Replace the Luer cap on top of the filter.
  5. Press to continue the prime.
    [INSERT FILTER PRIMED VIDEO – See other]
  6. When Dampening Chamber (1N) is primed to 2/3 full press to stop the pump.
  7. Close the WHITE clamp on the Dampening Chamber Air-inlet and replace the Luer cap.
  8. Remove the plastic hemostat on the Delivery line (1Q) below the Air Bubble sensor.
  9. Press to continue the prime.
  1. Verify that the Oxygenator bypass lines (1K & 2K) and Filter bypass lines (1G & 2G) are all primed and close all WHITE clamps.
  2. Check the disposables for leaks or air bubbles, ensuring that all connection are correctly fastened.

WARNING: In case of leaks or visible air entry, notify the Bridge to Life Service Department.

  1. Ensure that the Dampening Chamber (1N) remains at a level of 2/3 full.
  2. Allow Priming to complete. An increase of up to 250ml/min can be achieved until Priming is complete.
  1. After recirculating 1000 mL of solution, the Begin Perfusion option appears on the lower right of the LCD. Priming will continue. To finish the Priming phase, select Begin Perfusion and press CONFIRM.

Fig 6.3.20

The pump stops and the screen advances to ORGAN CONNECTION.

6.4   Organ connection

NOTE: Throughout the organ connection and flush phase, the organ remains in the flush bowl.

  1. Once the Priming phase is complete, prime the cannula which should already be attached to the organ.
  2. Attach the Delivery line to the cannula.[INSERT DELIVERY LINE CONNECTION VIDEO]
  1. Use the Selector Knob to press Confirm.

Fig 5.4.3

5.5   Organ flush phase

  1. Use the Selector Knob to select Zero Pressure and press the Selector Knob once to confirm.
  2. Verify that the values shown on the display are zero.

NOTE: This operation balances possible hydrostatic pressures due to different heights between the organ container and the VitaSmart pressure sensors.

  1. Use the Selector Knob to select and press PERFUSION. Highlight and press Confirm when the Confirm field appears.[INSERT FLUSH ZEROING VIDEO]

Fig 5.5.3

NOTE: During this phase, the RFID TAG is verified again. (See 5.1)

WARNING: If the height between the organ container and the VitaSmart is altered during perfusion phase, the pressure transducers will need to be re- zeroed to maintain accurate pressure readings

  1. When the TREATMENT screen appears, and prior to the start of flushing, set the pressure and flow parameters. The range of the parameters are listed below.[INSERT SET PARAMETERS VIDEO]

Fig 5.5.4

NOTE: It is the responsibility of the user to set the appropriate parameters for the treatment to be performed according to their institutions policy.

Due to the oscillating nature of the pump, the actual pressure value will slightly oscillate above and below the set value.

Max. Press. (RED) – Delivery Pump 1 pressure:

  • Maximum pressure in mmHg on the delivery line.
  • It can be set from 3 to 60 mmHg with 1 mmHg increments.

Max Flow – Maximum Delivery Flow of Pump 1:

  • Maximum flow in mL/min.
  • It can be set from 5 to 250 mL/min with 1 mL/min increments.

The system software automatically sets the delivery pump flow to maintain:

  • the delivery flow to be as close as possible to the set flow rate until the system reaches the pressure limit set by the operator.
  • the value of the delivery pressure to not exceed the set pressure.
  1. Press  to begin the flush and visually check that the pump is running.
  1. Use the Selector Knob to highlight and select Data Perfusion to monitor the Total Recirculated Solution fluid volume.[INSERT FLUSH MONITORING VIDEO]

Fig 5.5.6

  1. When the desired flush volume has been achieved, press .
  2. Record the Total Recirculated Solution used for the flush volume. (This number will be subtracted from the final total to determine the perfusion volume.)

5.6   Treatment

  1. Ensure the Pump is stopped and transfer the Organ from the flush bowl to the perfusion bowl.
  2. Re-zero the pressures (See 5.6.1)

5.6.1   Re-Zero Procedure

NOTE: Rezeroing is required before treatment and at any time the height of the organ is moved. Movement includes within the bowl, which may affect cannula height.

  1. Stop the Pump, if it isn’t already stopped, by pressing  once.
  2. Use the Selector Knob to select and press ALARMS.
  1. Use the Selector Knob to select and press ZERO PRESSURE and then CONFIRM.

Fig 5.6.1.3

  1. Ensure that the pressure values display zero.

Fig 5.6.1.4

  1. Use the Selector knob to select and press PERFUSION and then CONFIRM.
  2. Confirm the desired pressure and flow settings.
    [INSERT ZERO PRESSURE VIDEO]
  3. Press  to restart the treatment, and visually check that the pump is running.

You may continue to monitor the data (Total Recirculated Solution, Withdrawal Pressure, Duration) by selecting DATA PERFUSION.

  1. To end perfusion, select and confirm END PERFUSION.[INSERT END PERFUSION VIDEO]

Fig 5.6.1.8

Select Back to Perfusion to return the system to the Perfusion phase.

By selecting and confirming the END PERFUSION field, the system ends the procedure and you may disconnect the organ.

To change the minimum Withdrawal Pressure alarm, select ALARMS.

Fig 5.A