ORGAN ASSIST
DONORASSIST Instructions for Use
Instructions for Use
41 Pages
Preview
Page 1
Instructions for Use 61.01.601.02 EN
- Instructions for Use -
Model Numbers: 61.01.201; 61.01.203; 61.01.204 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 + 31 50 3131905 [email protected] www.organ-assist.nl 24/7 Helpdesk: (for urgent calls only) +31 50 3640116
61.01.601.02 EN
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- Instructions for Use -
1 PRODUCT DESCRIPTION INTENDED USE PUMP UNIT THERMO UNIT TROLLEY DISPOSABLE SET ORDERING INFORMATION PRODUCT SPECIFICATIONS
4 5 5 8 10 11 13 14
2 INSTALLATION
15
3 OPERATION
16
PREPARING THE PERFUSION PROCEDURE PREHEATING PRIMING PERFUSION PROCEDURE COLD FLUSH STOPPING THE OPERATION 4 CLEANING AFTER EVERY PROCEDURE WEEKLY: DISINFECTION THERMO UNIT YEARLY: DECALCIFYING THERMO UNIT
16 16 17 23 24 25 26 26 26 27
5 GENERAL SAFETY INSTRUCTIONS
29
6 TROUBLESHOOTING
31
FAULT MESSAGE EXPLANATION PROBABLE CAUSES
31 32
7 LIABILITY AND WARRANTY
33
8 CLASSIFICATIONS
33
MDD DECLARATION EMC DECLARATION APPENDIX A: GRAPHIC SYMBOLS APPENDIX B: ABBREVIATIONS
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33 34 38 39
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- Instructions for Use -
1 PRODUCT DESCRIPTION The DONOR ASSIST, from Organ Assist Products B.V. (referred as “OA”), perfuses organs with an oxygenated (non-) cellular fluid in the body of a (non) heart beating donor. The DONOR ASSIST is able to restore the circulation during the harvesting of the donor organs with pulsatile machine perfusion. The DONOR ASSIST is a modular system consisting of four main modules: • Pump unit • Thermo unit • Trolley • Disposable set The DONOR ASSIST may only be used with the following disposable set: MEH13 3940 or MEH13 4488. The following reusable accessories are included with the DONOR ASSIST: • Power cord thermo-unit • Power cord between pump and thermo unit • Data cable between pump and thermo unit • Pressure sensor cable • Level sensor • Temperature sensors (2x) • Flow sensor • Instructions for Use • Thermo water tubing • Water tubing coupler • Preheating dummy cable
Figure 1: DONOR ASSIST with pump unit, thermo unit and trolley
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- Instructions for Use -
‘l
INTENDED USE The DONOR ASSIST is intended to be used for normothermic regional pulsatile oxygenated machine perfusion of the donor abdominal body, for a period up to 6 hours.
PUMP UNIT
4 5 3 2 6 1
7
Figure 2: Front and rear view of the pump unit
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F
F
- Instructions for Use -
E
E
D
D
C
C
9 8
10 11 12
Figure 3: Right and left-hand side view of the pump unit
B 1. Control panel 2. Electrical power inlet 3. Data cable connection 4. Level sensor connection 5. USB connection 6. Equipotentiality pin 7. Product label A 8. Perfusion temperature connection (arterial = red) (T1) 215Q-003-00 9. Perfusion temperature connection (venous = blue) (T2) 10. 4Pressure sensor cable 3 connection 2 1 8 7 11. Flow sensor connection 12. Magnetic pump coupling UNLESS OTHERWISE SPECIFIED: DIMENSIONS ARE IN MILLIMETERS SURFACE FINISH: TOLERANCES: LINEAR: ANGULAR: NAME
DEBURR AND BREAK SHARP EDGES
FINISH:
SIGNATURE
DATE
DO NOT SCALE DRAWING
B
REVISION
TITLE:
DRAWN CHK'D
APPV'D
A
MFG Q.A
5
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MATERIAL:
DWG NO.
WEIGHT:
SCALE:1:5
A3
SHEET 1 OF 1
6
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- Instructions for Use -
CONTROL PANEL
Control display, showing menu and all relevant data
Display showing actual flow
Display showing perfusion temperature
Push-dial 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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E
- Instructions for Use -
THERMO UNIT
14 13
7
15
D
5
4
6
16
3
5
2
4
1
3
2
18
17
F
20 19
C Figure 5: Front and rear view of the thermo unit
E
22
D
B UNLESS OTHERWISE SPECIFIED: DIMENSIONS ARE IN MILLIMETERS SURFACE FINISH: TOLERANCES: LINEAR: ANGULAR:
DEBURR AND BREAK SHARP EDGES
FINISH:
SIGNATURE
NAME
DO NOT SCALE DRAWING
DATE
REVISION
TITLE:
C
DRAWN CHK'D APPV'D
A
MFG
MATERIAL:
Q.A
DWG NO.
21
215Q-002-00
Figure 6: Right and left-hand side view of the thermoSCALE:1:5 unit WEIGHT:
4
8
3 UNLESS OTHERWISE SPECIFIED: DIMENSIONS ARE IN MILLIMETERS SURFACE FINISH: TOLERANCES: LINEAR: ANGULAR: NAME
DATE
TITLE: NAME
CHK'D
CHK'D
APPV'D
APPV'D MFG
MFG Q.A
1 B
SIGNATURE
DEBURR AND REVISION BREAK SHARP
DO
EDGES
DATE
TITLE:
DRAWN
DRAWN
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SHEET 1 OF 1
7
DEBURR AND UNLESS OTHERWISE SPECIFIED: FINISH: DO NOT SCALE DRAWING BREAK SHARP ARE IN MILLIMETERS DIMENSIONS EDGES SURFACE FINISH: TOLERANCES: LINEAR: ANGULAR:
FINISH:
SIGNATURE
2
MATERIAL:
WEIGHT:
Q.A
DWG NO.
SCALE:1:5
A
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MATERIAL:
215Q-002-00 WEIGHT:SHEET 1 OF 1
A3
DWG NO.
SCALE:1:5
21
- Instructions for Use -
23
24
25
26
27
Figure 7: Thermo unit water tubing set; quick-connect thermo water connectors, flow indicator, thermo water coupling tube and tubing
13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27.
Thermo reservoir Data cable connection Electrical power outlet Electrical power inlet Equipotentiality pin Product label Thermo water inlet connector Thermo water outlet connector Air intake vents Air outlet vents Water connector Water tubing coupler Flow indicator Water drainage valve Quick connectors
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- Instructions for Use -
TROLLEY
28 29
31
27
32 30
33
34
Figure 8: trolley
28. 29. 30. 31. 32. 33. 34.
Infusion pole Push bar Level sensor Pressure sensor holder Reservoir holder Leukocyte filter holder Oxygenator holder
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- Instructions for Use -
DISPOSABLE SET
61 27
57 27
41 27
46 53
59
27
27
27
54 27
48 44
27
51
27
45 27
42 49 56 27
27
47
43
27
27
27
52
50
27
27
40 27
27
60 27
63 27
58
64
27
27
55 27
62 27
Figure 9: Disposable set MEH13 4488
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- Instructions for Use -
40. 41. 42. 43. 44. 45. 46. 47. 48. 49. 50. 51. 52. 53. 54. 55. 56. 57. 58. 59. 60. 61. 62. 63. 64.
Pump head Perfusion reservoir Oxygenator Tray with sterile tubing Venous inlet Arterial outlet Temperature sensor (T2, return) Bypass Venous bubble trap Oxygen inlet Thermo water inlet Thermo water outlet Oxygen outlet Inlet perfusion reservoir Outlet perfusion reservoir Pressure sensor (P1) Temperature sensor (T1, arterial) Drainage bag Arterial line Venous line Leukocyte filter Priming line Cold perfusion line Flow sensor connection position Leukocyte filter bypass
Extra accessories: 2 cannulas and leucocyte deairing tubing
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- Instructions for Use -
ORDERING INFORMATION The following DONOR ASSIST parts, accessories and single use disposables can be (re)ordered.
Item
Order number
Donor Assist
61.01.101 Pump unit
61.01.201
Thermo unit
61.01.203
Trolley
61.01.204
Disposable
61.01.402
Temperature sensor blue
05.01.301
Temperature sensor red
05.01.302
Flow sensor
05.01.303
Preheating dummy cable
05.01.339
Thermo unit water tubing set
05.01.327
Data cable
05.01.323
Training
61.01.801
Regular maintenance
05.01.802
See page 1 for address information or send your request to [email protected]
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- Instructions for Use -
PRODUCT SPECIFICATIONS Perfusion specifications Perfusion pump:
rotary pump, pulsatile 60 BPM
Perfusion flow:
up to 2.8 pulsatile L/min
Perfusion pressure:
up to 200 mmHg
Perfusion temperature:
30 °C - 37 °C
Accuracy of sensors:
Pressure: ± 1.5% or 1 mmHg Flow: ± 0.07 L/min Temperature: ± 1°C
Priming volume:
1.5 L
Displayed:
Perfusion time, flow, pressure, temperature, reservoir temperature, vascular resistance, menu, messages
Battery capacity:
90 minutes
Battery charging:
Self-charging if connected to mains (min. 8 h)
Power:
AC 110 - 230 V, 50/60 Hz
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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- Instructions for Use -
2 INSTALLATION The complete DONOR ASSIST is shipped in separate cardboard packages. The device should be unpacked and inspected by the responsible person. • • • • • • • • • •
Set the trolley in the correct position (figure 1). Position the pump and thermo units on the trolley. Secure each unit with the white clamps. Attach the holder (32) for the disposable set to the push bar (29) of the trolley. Connect supplied data cable to both Donor Assist units using the data connector on the back panel of both Donor Assist units (3) (14). Connect the level sensor (31) to the port on the back panel of the Donor Assist pump unit (4). Connect power cord at the back of the Donor Assist thermo unit (16). Connect the small power cord between both Donor Assist units (2) (15). Connect power cord to the mains with ground connection. Before first use, 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 DONOR 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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- Instructions for Use -
3 OPERATION PREPARING THE PERFUSION PROCEDURE Before starting the procedure, check the units, trolley, sensors, cables and connections. Do not use a damaged device. • • • • •
Set-up the Donor Assist (figure 1 and section 2) Power on the DONOR ASSIST by pushing the power button on the control panel. Press the push-dial button to activate the setup procedure. Connect dummy sensor to the pressure connector (10), if preheating is requested. Fill thermo unit (13) with 1.5 L demineralized water. 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.
PREHEATING
•
Set preferred temperature (30-37 °C).
• •
Press to start priming. After preheating, disconnect the dummy cable. The dummy cable is re-usable, make sure to separate it from the medical waste disposal after use.
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- Instructions for Use -
PRIMING
• • • • • • •
Unpack a sterile perfusion circuit. Place the perfusion reservoir (41) with the oxygenator (42) on the holder of the trolley (figure 10). Connect the pump head (40) to the magnetic pump coupling (12) (figure 10) Place leukocyte filter (60) in the holder (33) and connect de-airing tubing Connect the oxygen tubing (49) to the oxygen supply. Close clamp on the tubing where the drainage bag (57) can be connected. Press the push-dial button to proceed to the next step.
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 DONOR 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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- Instructions for Use -
‘click’
turn
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.
Connect the oxygenator to the holder situated on the trolley, by sliding it downwards over the pivot. Connect the perfusion reservoir at the holder and secure with the white turning knobs on top.
Figure 10: Connection of pump- head and oxygenator to the holder.
• • • •
Place the pressure sensor (55) in the holder on the perfusion pole (31). Connect temperature sensors according the color coding (figure 11) Connect T1 (red 56) to the arterial line of the disposable set (58) and T2 (blue, 46) to the inlet (53) of the perfusion reservoir (figure 13). Connect the flow sensor (figure 12).
Figure 11; Connecting the sensors
Make sure to connect the sensor connector 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.
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- Instructions for Use -
Open the flow sensor by pushing the aluminium clip to release the lid. Open the lid and clamp the sensor around the silicon tube (63). Push the lid to close the sensor.
Figure 12: Connecting the flow sensor
Make sure that the arrow on the flow sensor is facing the same direction of the flow through the tube (towards the body). Wrong connection of this sensor will not give a correct flow measurement.
push
turn
Figure 13: Connecting the temperature sensor
• •
Fill the system with the preferred priming solution (min. 1.5 L). When the system is filled properly, press push-dial button to proceed. In the DONOR ASSIST use certified priming solution only. Check the labelling of the priming 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 solutions that work best with the DONOR ASSIST. Using other solutions than priming solution with the DONOR ASSIST may result in organ damage or the cause of complications.
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- Instructions for Use -
• • • • •
Turn the push-dial button of the pump unit clockwise or counterclockwise to variate the flow speed. Variation of the pump output will remove air from the tubing of the disposable set. Clamp the arterial (58) and venous line (59) close to the tubing tray (43). Clamp the inlet of the leukocyte filter (60) to ensure retrograde priming. Open the port on top of the leukocyte filter. Open the bypass line (47). Gently prime the disposable to easily de-air the system. De-air the pump head (40) by uncoupling and moving the air towards the oxygenator. Remove residual air from the venous bubble trap by opening the 3-way valve (48). Remove residual air from the arterial outlet of the oxygenator (45). De-air the leukocyte filter. Reposition the clamp on the inlet of the filter to the leukocyte filter bypass line (64). Open arterial and venous line. De-air rest of the system. De-air pressure line and sensor (55). Close bypass. The system is now ready for use.
• •
Connect the water tubing (23) to the oxygenator (50, 51). Fill the water reservoir (13) of the thermo unit (1.5 L).
•
When display shows “ the next step.
•
• • • • • • • • • •
“, press push-dial button to proceed to
Make sure that the thermo water pump never runs dry! Only use distilled or demineralized water in the thermo reservoir.
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