3.2.3 Turning on the VitaSmart
- Insert a USB thumbdrive into the USB slot situated on the external monitor.
- Turn on the VitaSmart by pushing the Main Power Switch to the “I” position
3.3 Main menu
- Advance to the Technical Parameters Highlight, select and change each field (below) as required with the Selector Knob.
- 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.
5 Portal Vein Perfusion Treatment
5.1 Organ selection
- Use Selector Knob to select the PORTAL VEIN—LIVER The device will ask to confirm that the proper kit is used.
- 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.
- 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.
Portal Vein-Liver Tube Set (1)
1A- Withdrawal Port
1B- Withdrawal Sample Port
1C- Withdrawal 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- Dampening Chamber
1O- Dampening Chamber Air Inlet
1P- Delivery Delivery Pressure Transducer Line
1Q- Delivery Line
1R- Delivery Sample Port
1S- Delivery Port
T- Oxygenator Inflow Line
U- Oxygenator Outflow Line
V- Oxygen Inlet
W- Oxygen Supply Tubing
- Remove the Portal Vein-Liver Set (M90356) from the bag.
- Use the plastic support holder clamps to affix the external tubing support holder (located in the Portal Vein-Liver) to the perfusion bowl.
- 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.
- 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.
- Insert the Filter (1I) into the filter support.
- Insert the Dampening Chamber (1N) into the Dampening Chamber holder. Ensure that the Delivery Line exits at the bottom.
- Keeping the Delivery line (1Q) taut, insert the Delivery line tubing into the Air Bubble Detector by pressing or sliding it into position.
- 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.
- 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.
- Open the Pump 1 (front pump) cover.
- Lift to release the Pump 1 rotor lever.
- Following the direction of the arrows on Pump 1, start from the bottom and slowly insert the Pump Segment tube (1E) onto the rollers of Pump 1.
- 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.
- Manually rotate the rotor so the piece fits comfortably inside the Pump 1 housing.
- Close the rotor lever, VERIFYING THAT the pump Segment Line Connectors remain outside the pump housing.
- Close the Pump 1 cover.
- Clip the Oxygenator into the Oxygenator Support.
- 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).
- Connect the oxygen tube (V), to the dedicated oxygen inlet (W) of the oxygenator (GREEN to GREEN).
- Connect the other end of the oxygen tubing (V) to the oxygen source.
5.3 Priming Procedure
- Make sure the circuit has been connected as described above.
- Use the plastic hemostat to occlude the Delivery line (1Q) after the Air Bubble Detector.
- Open all RED, BLUE, and WHITE clamps on the tubing set.
- Remove the Luer cap from the top of the Filter (1I).
- Remove the Luer cap from top of the Dampening Chamber (1N).
- Select and confirm the Start Priming command to open the PRIMING screen.
- Use the Selector Knob to highlight the Flow Rate (ml/min).
- Press the Selector Knob so that the field turns from YELLOW to BLUE.
- Rotate the Selector Knob until you reach 100ml/min; Press to confirm (this will change the field from BLUE to YELLOW).
- When the filter is primed press to stop the pump. Replace the Luer cap on top of the filter.
- Press to continue the prime.
- When Dampening Chamber (1N) is primed to 2/3 full press to stop the pump.
- Close the WHITE clamp on the Dampening Chamber Air-inlet and replace the Luer cap.
- Remove the plastic hemostat on the Delivery line (1Q) below the Air Bubble sensor.
- Press to continue the prime.
- Verify that the Oxygenator bypass line (1K) and Filter bypass line (1G) are both primed and close both WHITE clamps.
- Check the disposable for leaks or air bubbles, ensuring that all connections are correctly fastened.
- Ensure that the Dampening Chamber (1N) remains at a level of 2/3 full.
- Allow Priming to complete. An increase of up to 250ml/min can be achieved until Priming is complete.
- 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.
The pump stops and the screen advances to ORGAN CONNECTION.
5.4 Organ connection
- Once the Priming phase is complete, prime the cannula which should already be attached to the organ.
- Attach the Delivery line to the cannula.
- Use the Selector Knob to press Confirm.
5.5 Organ flush phase
- Use the Selector Knob to select Zero Pressure and press the Selector Knob once to confirm.
- Verify that the values shown on the display are zero.
- Use the Selector Knob to select and press PERFUSION. Highlight and press Confirm when the Confirm field appears.
- 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.
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.
- Use the Selector Knob to highlight and select Data Perfusion to monitor the Total Recirculated Solution fluid volume.
- When the desired flush volume has been achieved, press .
- Record the Total Recirculated Solution used for the flush volume. (This number will be subtracted from the final total to determine the perfusion volume.)
- Ensure the Pump is stopped and transfer the Organ from the flush bowl to the perfusion bowl.
- Re-zero the pressures (See 5.6.1)
5.6.1 Re-Zero Procedure
- Stop the Pump, if it isn’t already stopped, by pressing once.
- Use the Selector Knob to select and press ALARMS.
- Use the Selector Knob to select and press ZERO PRESSURE and then CONFIRM.
- Ensure that the pressure values display zero.
- Use the Selector knob to select and press PERFUSION and then CONFIRM.
- Confirm the desired pressure and flow settings.
- 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.
- To end perfusion, select and confirm END PERFUSION.[INSERT END PERFUSION VIDEO]
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.