LIVERASSIST Instructions for Use

Model Numbers: 11.01.201, 11.01.202, 11.01.203, 11.01.204 or 215G002, 215G003, 215G004, 215G005. Patented

0086

For technical assistance and to reorder supplies and single use disposables, please contact:

Organ Assist Products B.V. Bornholmstraat 84 9723 AZ Groningen THE NETHERLANDS +3150 3131905 [email protected] www.organ-assist.nl 24/7 Helpdesk (for urgent calls only) +31 50 3640116

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PRODUCT DESCRIPTION

4

1.1 INTENDED USE 1.2 PUMP UNIT 1.3 THERMO UNIT 1.4 TROLLEY 1.5 DISPOSABLE SET 1.6 ORDERING INFORMATION 1.7 PRODUCT SPECIFICATIONS

5 5 8 10 11 12 13

2

INSTALLATION

14

3

OPERATION

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3.1 PREPARING THE PERFUSION PROCEDURE 3.2 PERFUSION PROCEDURE 3.3 STOPPING THE OPERATION 4

CLEANING 4.1 AFTER EVERY PROCEDURE 4.2 WEEKLY: DISINFECTION THERMO UNIT 4.3 YEARLY: DECALCIFYING THERMO UNIT

15 21 24 25 25 25 26

5

GENERAL SAFETY INSTRUCTIONS

28

6

TROUBLESHOOTING

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6.1 FAULT MESSAGE EXPLANATION 6.2 PROBABLE CAUSES

30 31

7

LIABILITY AND WARRANTY

32

8

CLASSIFICATIONS

32

8.1 MDD DECLARATION 8.2 EMC DECLARATIONS APPENDIX A: GRAPHIC SYMBOLS APPENDIX B: ABBREVIATIONS

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1 PRODUCT DESCRIPTION The LIVER ASSIST, from Organ Assist Products B.V. (referred as “OA”), is a pump system providing temperature controlled dual oxygenated isolated perfusion of donor livers to bridge the time span between donor hepatectomy and liver transplantation in the recipient. The LIVER ASSIST is a modular system consisting of five main modules: • PV pump unit (for Portal Vein perfusion) • HA pump unit (for Hepatic Artery perfusion) • Thermo unit • Trolley including table top • Disposable set The LIVER ASSIST may only be used with the following disposable set: MEH13 3411. The following reusable accessories are included with the LIVER ASSIST: • Power cord thermo unit • Power cord between both (PV & HA) pump units and thermo unit • Data cable between (PV & HA) pump units and thermo unit • Pressure sensor cables (2x) • Temperature sensors (3x) • Flow sensors (2x) • Instructions for Use • Thermo water tubing • Water tubing couplers (2x)

Figure 1: LIVER ASSIST, with pump units, thermo unit, and disposable holder connected to the trolley

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1.1 INTENDED USE The LIVER ASSIST is intended to be used for isolated ex-vivo oxygenated machine perfusion of donor livers, for a period up to 6 hours.

1.2 PUMP UNIT

Figure 2: Front and rear view of the pump units.

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10 11

12 13 14 Figure 3: Right and left-hand side view of the pump units

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14.

Control panel Oxygen cylinder Oxygen cylinder compartment Electrical power inlet Data cable connection USB connection Equipotentiality pin Product label Screw joint Reservoir temperature connection (T2) Perfusion temperature connection (T1) Pressure sensor cable connection Flow sensor connection Magnetic pump coupling

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CONTROL PANEL

Control display, showing menu and all relevant data

Display showing perfusion temperature

Display showing actual flow

OK-button Up-button

Down-button

Attention indicator

Attention temperature indicator

Power indicator

Pump on/off indicator

Power button

Pump on/off button

Mute button Figure 4: Control panel.

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1.3 THERMO UNIT 16 17 18 19 20

21 22 15

23

Figure 5: Front and rear view of the thermo unit

24 24

25

Figure 6: Right and left-hand side view of the thermo unit

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29a

27

26

28

29

Figure 7: Accessories thermo unit; quick-connect thermo water connectors, flow indicator, thermo water coupling tube and tubing

15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 29a

Thermo reservoir Electrical power inlet Data cable connection Electrical power outlet Equipotentiality pin Product label Screw connection for fixation on trolley Thermo water inlet connector Thermo water outlet connector Air intake vents Air outlet vents Water connector Water tubing coupler Flow indicator Water drainage valve Thermo tubing de-airing balloon

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1.4 TROLLEY 31

30 36

36 32

33

34

35

Figure 8: trolley

30. 31. 32. 33. 34. 35. 36.

Table Organ reservoir holder Push Bar Oxygenator holder Screw holes for connection of pump and thermo units Product label Pressure sensor holder

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1.5 DISPOSABLE SET

Figure 9. Disposable set

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1.6 ORDERING INFORMATION The following LIVER ASSIST parts, accessories and single use disposables can be (re)ordered: Item

Order number

LIVER ASSIST

11.01.101 Pump unit (PV)

11.01.201

Pump unit (HA)

11.01.202

Thermo unit

11.01.203

Trolley

11.01.204

Work table

11.01.212

Disposable

11.01.401

Temperature sensor blue

05.01.301

Temperature sensor red

05.01.302

Flow sensor ¼”

05.01.303

Bile collection reservoir

11.01.501

Bile collection cannula - 6 Fr

11.01.502

Cannula for organ perfusion - 8 Fr

05.01.507

Cannula for organ perfusion - 10 Fr

05.01.503

Cannula for organ perfusion - 12 Fr

05.01.504

Patch cannula -small

05.01.508

Patch cannula -medium

05.01.509

Patch cannula -large

05.01.510

Aortic cannula - 28 Fr

11.01.519

Portal cannula -28 Fr

11.01.520

Thermo water tubing set

11.01.326

Training

11.01.801

Regular maintenance

05.01.802

See page 2 for address information or send your request to [email protected].

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1.7 PRODUCT SPECIFICATIONS Perfusion specifications Perfusion pump:

Rotary pump, pulsatile 60 BPM (HA) + continuous (PV)

Perfusion flow:

HA: up to 1000 ml/min PV: up to 2.5 L/min

Perfusion pressure:

HA: up to 50 mmHg @12°C up to 110 mmHg @ 37 °C PV: up to 11 mmHg @ 12 °C up to 16 mmHg @ 37 °C

Perfusion temperature:

12 °C - 37 °C

Accuracy:

Pressure: ± 1.5% or 1 mmHg Flow: ± 0.07 L/min Temperature: ± 1°C

Perfusion solution:

Any certified machine perfusion preservation solution (2-4 L)

Displayed:

Perfusion time, flow, pressure, temperature, reservoir temperature, vascular resistance, menu, messages

Battery capacity:

20 minutes

Battery charging:

Self-charging if connected to Mains (min. 8 h)

Power:

AC 110 - 230 V, 50/60 Hz

Fuses (HA/PV):

Littlefuse: 0215002.txp 2AT 250V HBC

Fuses thermo unit:

Littlefuse: 0215008.txp 8AT 250V HBC

Maximum load on table top:

15 kg, including organ and perfusion solution

Storage conditions:

Temperature 5-40°C, 30 - 85 %RH

Operating conditions:

Room temperature 18-24°C, 30 - 85 %RH

Product life time

7 years

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2 INSTALLATION The complete LIVER ASSIST is shipped in separate cardboard packages. The device has to be unpacked, checked and installed by an OA authorized person. • • • • • • • • •

Set the trolley in the correct position (figure 8). Position the pump and thermo units on the trolley, the HA pump unit on the left side, the PV pump unit on the right side (figure 1). Secure each unit with 2 bolts to the trolley (34). Attach the aluminum holder (33) for the disposable system to left and righthand side of the trolley and secure the holder using the screw clamp. Connect supplied data cable to the LIVER ASSIST units using the data connector on the back panel of the LIVER ASSIST (5) (17) (5). Connect power cord to the IEC inlet located on the back panel of the thermo unit (18). Connect power cord with Y junction to both pump units and the thermo unit (4) (16). Connect power cord to the mains with ground connection. Disinfect the thermo unit as described in section 4.2.

The mains should be easily accessible to disconnect the device from mains. Do not replace the IEC power cord or fuses. This modification will void the warranty and violates the conformity of the LIVER ASSIST with the requirements of the Medical Device Directive 93/42/EEC. Do not block the air intake vents and air outlet vents of the thermo unit.

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3 OPERATION 3.1 PREPARING THE PERFUSION PROCEDURE Before starting the procedure, check the units, trolley, sensors, cables and connections. Do not use a damaged device. • •

Power on the LIVER ASSIST by pushing the power button on the control panel. Press the OK-button to activate the setup procedure. A sequence of message screens will guide you through set-up and running. Extra messages will pop-up when actions are required, see section 6.1.

HEPATIC ARTERY

• • • • •

PORTAL VEIN

Unpack a sterile perfusion circuit. Place the organ reservoir into the holder of the table, use the red tubing at the arterial side (HA) and the blue tubing at the portal side (PV). Place the oxygenators on the holders (figure 10). Connect the pump head to the magnetic pump coupling (14), located on the outer sides of the LIVER ASSIST (figure 10). Connect the oxygenators to the oxygen supply using the green tube with the incorporated gas filter.

Gas supply: It is preferable to make use of the gas supply of the operating theatre. Consult the instructions of the oxygenator for requirements of the oxygen supply. When there is no oxygen/gas supply available a cylinder can be used. When a cylinder is used always check if there is enough gas available in the cylinder. OA is not responsible for incorrect use of the gas supply. The LIVER ASSIST should not to be used in contact with flammable agents, gases or liquids and not to be used in an oxygen rich environment.

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‘click’

turn

Connect the oxygenator to the holder situated on the trolley, by sliding it downwards over the pivot.

Push and turn the pump head into the slot of the perfusion pump to secure the connection. Make sure the outlet of the pump-head is pointing upwards when connected.

Figure 9: Connection of disposable pump-head to pump and oxygenator to the holder. Figure 10. Connection of pump-head and oxygenator to the holder.

• • • • •

• •

Place the pressure sensors to each side of the table (36). Connect the pressure sensor cables to the pump units (12) and to the pressure sensors. Connect temperature sensors (10,11) according the color coding (figure 11) Connect the HA T1 sensor (red) to the HA oxygenator outlet and the PV T1 sensor (red) to PV oxygenator outlet (figure 9 and 13). Connect the PV T2 sensor (blue) to the PV perfusion line. Connect the flow sensor (13). Make sure to connect the sensor connection with the red dot facing upwards. Every sensor is different and is not interchangeable. Connect the sensors to the right sub connectors, else it could cause damage. Do not spill any fluid on the electronic connectors; this may cause a deviation of the measured values or to an alarm. Do not load more than 15 Kg on the table top, including organ and liquids.

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Figure 11: Connecting the sensors

Open the flow sensor by pushing the aluminum clip to release the lid. Open the lid and clamp the sensor around the silicon tube. Push the lid to close the sensor.

Figure 12: Connection of flow sensor to disposable system

Make sure that the arrow on the flow sensor is facing the same direction of the flow through the tube (towards the reservoir). Wrong connection of this sensor will not give a correct flow measurement.

push turn

Figure 13: Connection of the temperature sensor to the disposable system

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• •

Fill the system with the preferred perfusion solution (min. 2 L). When the system is filled properly, press OK-button to proceed. In the LIVER ASSIST, use certified machine perfusion solution only. Check the labelling of the perfusion solution and make sure that it is intended for machine perfusion. If you are uncertain about which solutions are appropriate, contact OA for information on recommended perfusates that work best with the LIVER ASSIST. Using other solutions than machine perfusion solution with the LIVER ASSIST may result in organ damage or the cause of complications.

HEPATIC ARTERY

• •

• •

PORTAL VEIN

Start priming on PV side first. If completed than prime HA side. Press the up- and down-buttons of the PV and HA pump to variate the flow speed. Variation of the pump output will remove air from the tubing of the disposable circuit. De-air pump head and bubble trap in the oxygenator to the filling line. De-air arterial filter.

Please note that only the PV unit is able to read the status of the thermo unit. • Connect the water tubing (26) to the oxygenators. • Fill the water reservoir (15) of the thermo unit (3 L). • Use the thermo tubing de-airing balloon (29a) to start an initial circulation in the thermo tubing. Make sure that the thermo water pump never runs dry! Only use demineralized water (optional ice) in the thermo reservoir.

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HEPATIC ARTERY

• • • • • •

PORTAL VEIN

Remove cap on top of the pressure sensor (transducer) and place a sterile syringe on the opened port (figure 14). Pull the blue snap tab while aspirating with the syringe until the pressure line is de-aired and there is enough perfusion solution in the syringe. Remove the syringe and close opening with a sterile cap. Turn valve on the pressure sensor downwards (counter clockwise). Press the OK-button and the pressure sensor will now be zero’d against atmospheric pressure. Turn the valve of the pressure sensor back to measuring position (clockwise, figure 14).

Figure 14: Priming and zero-ing of the pressure transducer

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Before continuing to the next step, please ensure that the pressure sensor valve is in the correct position (figure 14).

HEPATIC ARTERY

PORTAL VEIN

°

•

Set the preferred temperature of the perfusion solution by using the up- and down buttons. Press OK-button to confirm and to proceed to the next step.

• •

Set the preferred perfusion pressure of the HA and PV unit. Press OK-button to confirm and to proceed to the next step.

•

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