XVIVO 11.01.201 Instructions For Use Manual Download Page 37

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11.01.601.7c EN

Page 37 of 40

Warning

LOT number

SERIAL number

Sterile, method using Ethylene Oxide

Reference model number

Do not reuse or resterilize, single use only

Do not use if package is damaged

Date of manufacture

Manufacturer

Storage condition, temperature

Indicates the range of humidity to which the medical device can be
safely exposed

Indicates the range of atmospheric pressure to which the medical
device can be safely exposed

To ensure grounding reliability, use hospital or commercially
grounded electrical connections only

Do not open the device! Risk of an electrical shock

Read the instructions for use before operating the device

CE mark and Notified Body number

85%

30%

106kPa

50kPa

2797

Summary of Contents for 11.01.201

Page 1: ...11 01 601 07a EN ...

Page 2: ... 11 01 203 11 01 204 Patented 2797 MedEnvoy Switzerland Gotthardstrasse 28 6302 Zug Switzerland XVIVO B V Bornholmstraat 84 9723 AZ Groningen THE NETHERLANDS 3150 3131905 info xnl xvivogroup com www xvivogroup com 24 7 Helpdesk for urgent calls only 31 50 3640116 ...

Page 3: ...ure 22 3 3 In hospital transport 25 3 4 Stopping the operation 25 4 Cleaning 26 4 1 After every procedure 26 4 2 Weekly disinfection thermo unit 26 4 3 Yearly decalcifying thermo unit 27 5 General safety instructions 28 6 Alarms and troubleshooting 30 6 1 Alarm signals 30 6 2 Alarm message explanation 31 6 3 Probable causes 32 7 Liability and warranty 32 8 Disposal 33 9 Classifications 33 9 1 MDD ...

Page 4: ... perfusion Thermo unit Trolley including table top Disposable set The Liver Assist may only be used with the following disposable sets NL40046511 order number 11 451 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 Temper...

Page 5: ...hecks the organ on quality for transplantation and removes the organ from the device non sterile perfusionist he she prepares the device for use places and primes the disposable system and operates the device during the perfusion period After perfusion the perfusionist cleans the device Indications for use Indications for use of the Liver Assist include in hospital machine perfusion of donor liver...

Page 6: ...ygen cylinder compartment 4 Electrical power inlet 5 Data cable connection 6 USB connection 7 Equipotentiality pin 8 Product label 9 Screw joint 10 Reservoir temperature connection T2 11 Perfusion temperature connection T1 12 Pressure sensor cable connection 13 Flow sensor connection 14 Magnetic pump coupling 10 11 12 13 14 ...

Page 7: ...ng perfusion temperature Pause audible alarm button Control display showing menu and relevant data Down button Pump on off indicator Display showing actual flow Attention indicator Power indicator Pump on off button Power button Attention temperature indicator OK button Up button ...

Page 8: ...11 01 601 7c EN Page 8 of 40 Figure 5 Front and rear view of the thermo unit Figure 6 Right and left hand side view of the thermo unit 24 25 15 16 17 18 19 21 22 23 20 24 ...

Page 9: ...ower inlet 17 Data cable connection 18 Electrical power outlet 19 Equipotentiality pin 20 Product label 21 Screw connection for fixation on trolley 22 Thermo water inlet connector 23 Thermo water outlet connector 24 Air intake vents 25 Air outlet vents 26 Water connector 27 Water tubing coupler 28 Flow indicator 29 Water drainage valve 29a Thermo tubing de airing balloon 26 27 28 29 29a ...

Page 10: ...age 10 of 40 Figure 8 Trolley 30 Table 31 Organ reservoir holder 32 Push Bar 33 Oxygenator holder 34 Screw holes for connection of pump and thermo units 35 Product label 36 Pressure sensor holder 30 34 35 31 33 32 36 36 ...

Page 11: ...re sensor T2 connection 43 Sample line PV 44 Oxygenator PV 45 Oxygen line PV 46 Pump head PV 47 Flow sensor tube PV 48 Perfusion lines PV 49 Bile line 50 Filling line HA 51 Pressure sensor HA 52 Sample line HA 53 Oxygen line HA 54 Oxygenator HA 55 Pump head HA 56 Flow sensor tube HA 57 Perfusion lines HA 37 39 41 44 45 46 48 49 42 47 43 40 38 51 53 54 55 57 52 56 50 ...

Page 12: ...w sensor 05 01 303 Bile collection reservoir 11 01 501 Bile collection cannula 8 Fr 11 01 546 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 25 Fr 11 01 519 Portal cannula 25 Fr 11 01 520 Thermo water tubing se...

Page 13: ...menu messages Alarm Alarm sound level pressure 65 dB A Battery capacity 20 minutes Lithium ion Battery 11 25V 8850mAh 99 6Wh Battery charging Self charging if connected to Mains min 8 h Power AC 110V 60 Hz or 230V 50 Hz 880 VA 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 ...

Page 14: ... 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 earth connection Connect the Liver Assist to the hospital potential equalization connector with an equipotential cable to ensure the potential equalization of the Liver Assist wit...

Page 15: ...t the arterial side HA and the blue tubing at the portal side PV Place the oxygenators on the holders figure 10 Figure 10 Connection of oxygenator to the holder Connect DISPOSABLE Press to continue Connect DISPOSABLE Press to continue PORTAL VEIN HEPATIC ARTERY Before starting the procedure check the units trolley sensors cables and connections Do not use a damaged device A sequence of message scr...

Page 16: ... 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 XVIVO is not responsible for incorrect use of the gas supply Place the pressure sensors to each side of the table 36 Connect the pressure s...

Page 17: ...ors 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 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 Make sure that the arrow on the flow sensor is facing the same direction of the flow through the t...

Page 18: ...htly and maintain sterility Remove the yellow de airing cap on both oxygenators see figure 15 Do not discard these yellow caps store carefully Fill the system with the preferred perfusion solution min 2 L via both filling lines After filling close the filling lines by the clamps and the swivel valves to avoid unintended leakages Figure 15 Connection of filling line When the system is filled proper...

Page 19: ...the yellow caps on both oxygenators 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 with 3 Liters of demineralized water 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...

Page 20: ...alve on the pressure sensor transducer counterclockwise to open the sensor to measure atmospheric pressure and remove the cap see figure 15 Press the OK button to zero the sensor to atmospheric pressure This step will take a few seconds Turn the pressure sensor valve back to measuring end position clockwise see figure 15 Re place the cap Figure 15 Priming and zeroing of the pressure transducer Pre...

Page 21: ...e of the HA and PV unit Press OK button to confirm and to proceed to the next step Set Pressure Setpt Press to adjust Value mmHg Press to continue Set Temp Setpoint Press to adjust Value C Press to continue Set Pressure Setpt Press to adjust Value mmHg Press to continue PORTAL VEIN HEPATIC ARTERY Before continuing to the next step please ensure that the pressure sensor valve is in the correct posi...

Page 22: ... sterile area Place liver in reservoir De air and connect cannulas to corresponding inlet tubing Start arterial and portal perfusion Close reservoir with inner and outer lid Figure 15 Pressure loss corrections 0 50 100 150 200 250 300 0 200 400 600 800 1000 Pressure drop mmHg Flow ml min 8Fr 10Fr 12Fr 0 1 2 3 4 5 0 500 1000 1500 2000 2500 3000 Pressure drop mmHg Flow ml min 25Fr PV 25Fr HA When us...

Page 23: ...e After the perfusion procedure is started please check all connections and check if the present flow and pressures are as intended Make sure that the device works as intended and does not resonate produces extreme noise or shows other shortcomings When an error or malfunction appears please review the troubleshooting section in chapter 6 of this manual If the troubleshooting section does not solv...

Page 24: ...ssure to prevent damage or organ loss These values are a preset safety value and cannot be changed In case the limit is reached the device will reduce pump speed to maintain safe perfusion pressure and flow Permittable pressures at different temperatures are shown in figure 16 Figure 16 Pressure limits Permittable flows at different temperatures are shown in the figure 17 Figure 17 Flow limits ...

Page 25: ... 1 4 to push the device to another location Engage the brakes on the wheels of the trolley Connect the equipotential cable to the potential equalization connector Connect the power cable to a grounded mains outlet keep connected to charge the battery Connect the oxygen line to the oxygen supply Switch off the HA and PV pump unit by pressing the pump buttons Switch off the whole system by pressing ...

Page 26: ...27 3 way tap and lid of thermo unit reservoir 15 using a surface disinfectant 5 Close the water circuit 6 Add 2 liters 0 5 Chloramine T solution to the thermo unit reservoir 7 Connect sensors Connect the flow sensor temperature sensors and pressure sensor cable to the PV pump unit Submerge the flow sensor in a cup with tap water Connect separate pressure sensor e g from a used disposable set or ne...

Page 27: ...e PV pump unit Submerge the flow sensor in a cup with water Connect separate pressure sensor e g from a used disposable set or new standard pressure sensor Edwards Truwave Note No need to connect a complete disposable system After the waiting time 7 Power on the PV pump unit 8 Skip through setup procedure by pushing the OK button on the PV pump unit Push until the display shows pressure zeroing 9 ...

Page 28: ...ot completely shut off all power from the device The power supply of the Liver Assist thermo unit will still produce a low noise when the Liver Assist is switched off The mains plug of the power supply is the separator that connects or disconnects the Liver Assist from the mains Avoid positioning the equipment such that access to the mains plug etc is limited so that disconnection becomes difficul...

Page 29: ...nsducers and cables other than those specified with the exception of replacement parts sold by XVIVO could result in increased electromagnetic emissions or decreased electromagnetic immunity of the Liver Assist and result in improper operation Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any...

Page 30: ...er configured alarm preset is available which is automatically restored after power interruption The generation of the alarm cannot be inactivated The audible signal can be temporarily paused by pressing the pause audible alarm button this will disable the audible signal for 3 minutes meanwhile the visible alarm signal will remain After 3 minutes the audible alarm will continue The alarm signal sh...

Page 31: ...ow Fill THERMO UNIT Level too low in thermo unit Loose or open connection Check connections thermo tubing data cable Fill thermo unit with water LP WARNING Battery power low Connect Mains Battery nearly empty Device disconnected from mains Connect the device to AC Power LP WARNING No Flow data Flow sensor measurement error Wrong reading Reconnect flow sensor LP WARNING Mains disconnected Connect M...

Page 32: ...ction Pump failure Reconnect pressure sensor Reconnect pump head Call XVIVO service Continue preservation using static cold storage Temperature does not change No water too much air in water tubing and thermo unit De air water tubing and or add water to thermo unit Missing or incorrect display elements at power on Display or internal computer failure Power off wait for 1 minute and power on Discon...

Page 33: ... countries outside of the European Union local regulations must be followed for the disposal of the Liver Assist Classification to 93 42 EEC Class IIa Classification to IEC 60601 1 Class I Classification to IEC 62304 Class A Protection against electrical shock Type B Directive s Council Directive 93 42 EEC annex II Standard s Safety International Standard IEC 60601 1 EMC International Standard IEC...

Page 34: ... communication services The user might need to take mitigation measures such as relocating or re orienting the equipment Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Table 2 Guidance and manufacturer s declaration electromagnetic immunity The Liver Assist is intended for use in the electromagnetic environment specified below The customer or...

Page 35: ...etic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Conducted RF IEC 61000 4 6 3V 0 15 to 80 MHz 6 V in ISM bands between 0 15 80 MHz 80 AM at 1 kHz 3V 0 15 to 80 MHz 6 V in ISM bands between 0 15 80 MHz 80 AM at 1 kHz Portable and mobile RF communications equipment should be...

Page 36: ...8 28 710 704 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 2 0 3 28 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217 Hz 2 0 3 28 28 1845 1970 2450 2450 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation 217 Hz 2 0 3 28 28 5...

Page 37: ...temperature Indicates the range of humidity to which the medical device can be safely exposed Indicates the range of atmospheric pressure to which the medical device can be safely exposed To ensure grounding reliability use hospital or commercially grounded electrical connections only Do not open the device Risk of an electrical shock Read the instructions for use before operating the device CE ma...

Page 38: ...peres AC Alternating current BPM Beats per minute C Degrees Centigrade CE Conformité Européenne cm Centimeter 1 cm 01 m DC Direct current EMC Electromagnetic compatibility EU European Union h hour Hz Hertz IEC International Electrotechnical Commission kg Kilogram 1 kg 1000 g 2 2 lbs KPa Kilopascal 1 Pa 0 01 millibar L Liter 1L 0 001 m3 LCD Liquid Crystal Display LED Light Emitting Diode MDD Medica...

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