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TRA

Operator’s Manual

20077/021 US

B-1

Appendix B: Approvals and Test Certificate

The X

TRA

and X

VAC

equipment have been tested and comply with the following:

EMC Standards

(See

Appendix A: Safety Standards EN 60601-1-2

)

EMC Emission

• IEC 60601-1-2

: 2007 and : 2014

EMC Immunity

• IEC 60601-1-2

: 2007 and : 2014

Electrical and Mechanical Safety Standards

• IEC 60601-1

Edition 3.1

Certification

• C-US NRTL Certification

• CB Certification

The LivaNova quality assurance system complies with the following standards:

• UNI - EN - ISO - 13485

Summary of Contents for 75220

Page 1: ...Operator s Manual SOFTWARE VERSION 2 00 20077 021 US FOR US MARKET ONLY...

Page 2: ...rademarks of the Microsoft Corporation Manufacturer LivaNova Deutschland GmbH Lindberghstrasse 25 D 80939 M nchen Germany Tel 49 0 89 32301 0 Fax 49 0 89 32301 555 Distributor in U S A LivaNova USA In...

Page 3: ...1 17 Disposal in Accordance with Environmental Regulations 1 18 Chapter 2 Overview Advantages of Intra and Postoperative Red Cell Recovery 2 1 Clinical Applications 2 1 Description of the XTRA System...

Page 4: ...Wash Lines to the Saline solution Containers 4 10 Step 6 Hanging the Waste Bag 4 10 Other Setups 4 11 Blood Collection 4 11 Procedure for Removing Disposables 4 12 Chapter 5 Processing Operating the...

Page 5: ...usion Line Prime IV 6 4 Removing Air From the RBC Bag The Purge Cycle 6 6 Reinfusion 6 7 Description 6 7 Connecting the Blood Administration Set to the XTRA RBC Bags 6 8 Chapter 7 Automated Functions...

Page 6: ...entrate Cycle With the PPP PRP Protocols 10 16 Dealing With Expected Warnings During a Cycle 10 17 Whole Blood Bag Empty 10 17 PPP Bag Full 10 18 PRP Bag Full 10 18 RBC Bag Full 10 18 Finishing Preope...

Page 7: ...larms 13 8 List of Fatal Alarms 13 8 Alarm Management in Local Control 13 8 Alarm Management in Remote Control 13 8 Chapter 14 Troubleshooting General Precautions 14 1 Supervision and Checks 14 1 Alar...

Page 8: ...uidance and manufacturer s declaration A 1 Technical description A 5 Appendix B Approvals and Test Certificate EMC Standards B 1 EMC Emission B 1 EMC Immunity B 1 Electrical and Mechanical Safety Stan...

Page 9: ...Touch Screen Display Panel 3 8 Figure 3 13 Centrifuge Assembly 3 9 Figure 3 14 Centrifuge Well Fluid Container 3 10 Figure 3 15 Left Clamps With Clamp Lid Open Right Clamp Lid Closed and Latched 3 11...

Page 10: ...oop Cartridge Left Latching the Clamp Lid Right 4 9 Figure 4 9 Connecting the Bowl Set to the Top of the Blood Collection Reservoir 4 9 Figure 4 10 Connecting the Bowl Set to the Bottom of the Blood C...

Page 11: ...in Manual Mode 5 32 Figure 5 31 Wash Phase in Manual Mode 5 33 Figure 5 32 Empty Phase in Manual Mode 5 33 Figure 5 33 Protocol Mode Tab 5 34 Figure 5 34 Example Alarms Disabled Confirmation Screen 5...

Page 12: ...Tab of the Configuration Mode 8 6 Figure 8 5 Wakeup Tab of the Configuration Mode 8 7 Figure 8 6 Display Tab of the Configuration Mode 8 8 Figure 8 7 Warnings Tab of the Configuration Mode 8 8 Figure...

Page 13: ...f the Menu Screen 11 3 Figure 11 4 ID Tab of the Menu Screen 11 4 Figure 11 5 Past Cases Screen 11 5 Figure 11 6 Destination Drop Down Menu Expanded 11 6 Chapter 12 Quality Management Option Figure 12...

Page 14: ...acement of the Paper Roll 15 8 Figure 15 9 Removal of the Centrifuge Well Fluid Container 15 8 Chapter 16 Technical Data Chapter 17 Warranty Appendix A Safety Standards EN 60601 1 2 Appendix B Approva...

Page 15: ...e patient so that plasma containing platelets and clotting factors can be returned to the patient The XTRA utilizes the Latham centrifuge bowl designed specifically for blood processing during any kin...

Page 16: ...g protocols and about creating custom protocols using the Programmability Option Chapter 10 Preoperative Sequestration PPP and PRP Details the procedures for carrying out preoperative sequestration in...

Page 17: ...writing by the company All electrical installations must comply with all applicable local electrical codes and company specifications 2 Read the instructions carefully prior to use Prior to use this m...

Page 18: ...on Special Conditions Acute normovolemic hemodilution whole blood Room temperature 8 hours N A None Acute normovolemic hemodilution whole blood 1 6 C 24 hours N A Storage at 1 6 C shall begin within 8...

Page 19: ...ions of particulate matter infusion and the risk of air embolism use of an in line microaggregate filter on the patient reinfusion line is STRONGLY RECOMMENDED 20 Do not reinfuse under pressure i e do...

Page 20: ...ould activate clotting 1 Do not aspirate into system 2 Irrigate wound before resuming salvage 3 Thoroughly wash salvaged blood Antibiotics not licensed for intravenous use May be delivered in higher d...

Page 21: ...he rotor into its seat turn it until aligns with the slot of the metal shaft and reposition the white lever into the slot 34 During the use and transportation of the unit do not exceed the maximum loa...

Page 22: ...In case a partial bowl is washed the hematocrit of the collected blood as well as the removal of waste components might be lower than expected 51 The maximum volume in the RBC bag is 1 liter To avoid...

Page 23: ...e socket by gripping it with the hand Do not pull on the power cord 8 Ensure that the plug is secured to the machine by means of the metallic grid see Figure 5 12 to prevent accidental unplugging 9 To...

Page 24: ...lation during blood collection can cause excessive clotting in and possible clogging of the collection reservoir or centrifuge bowl 6 Incorrect assembly of the vacuum overflow trap or assembly using d...

Page 25: ...to significant physical damage A machine that has given anyone an electrical shock while in use A machine that appears to be overheating 23 It is the responsibility of the health care institution to a...

Page 26: ...machine off and on might resolve the problem c if the problem persists contact authorized technical service 42 The Waste bag must not be squeezed while treatment is being done and must have the space...

Page 27: ...ue to availability of the return function 57 During setup and unload of the kit the patient must not be connected to the reservoir through the drainage line 58 The deactivation of the RBC Detector is...

Page 28: ...e unit in the presence of inflammable anaesthetic gases do not expose to heat sources Avoid any operating situation where the blood may be exposed to temperatures exceeding 37 C 98 6 F Cautions 1 When...

Page 29: ...or directly to LivaNova to the following address LivaNova Deutschland GmbH Lindberghstrasse 25 D 80939 M nchen Germany Tel 49 0 89 32301 0 Fax 49 0 89 32301 555 Storage and Transport Conditions Impor...

Page 30: ...39 M nchen Germany Tel 49 0 89 32301 0 Fax 49 0 89 32301 555 Distributor in U S A LivaNova USA Inc 14401 West 65th Way Arvada Colorado USA 80004 Tel 1 800 221 7943 Tel 1 303 425 5508 Fax 1 303 467 658...

Page 31: ...uct must be returned to the company a returned goods authorization RGA number is required prior to shipping If the product has been in contact with blood or body fluids it must be thoroughly cleaned a...

Page 32: ...vative ElektroG All disposables used in conjunction with the XTRA System must be disposed of in accordance with the local and environmental regulations Observe hospital regulations when disposing of t...

Page 33: ...nous malformation repair Valve replacements and coronary artery bypass grafts Primary and revision hip and knee arthroplasty spinal repair and Harrington rod procedures Ectopic pregnancies Major traum...

Page 34: ...1 liter primary RBC bag Except for the waste bags XTRA Bowl Set components are preconnected for ease of installation and to maintain the sterility of the system The Aspiration line designed to mix the...

Page 35: ...amed for what is occurring in the centrifuge bowl Fill In the Fill phase blood is introduced from the reservoir into the spinning centrifuge bowl The higher density red blood cells are packed against...

Page 36: ...ted or another waning condition happens 1 Touch The XTRA will start automatically when a certain level of fluid is reached in the reservoir and will fill wash and empty the centrifuge bowl continuousl...

Page 37: ...operative Preoperative Sequestration Option PPP and PRP The preoperative sequestration option enables recovery of plasma and platelets from blood by drawing blood from the patient into bags Whole bloo...

Page 38: ...on of the removal rate of supernatant and thus plasma contaminants Waste line indicator option It enables the indication of the waste line color when the saline solution is being pumped into the bowl...

Page 39: ...RA Front View 1 IV pole 10 Lower IV pole arm and hooks 2 Touch screen display panel 11 Rear handle 3 Reservoir holder 12 Stop button 4 Centrifuge lid 13 IV pole locking levers 5 Front handle 14 Centri...

Page 40: ...ower cord wrap 8 Reservoir pole locking lever 3 Rear transport handle 9 Printer 4 XVAC electrical connection upper callout 10 Rear panel Ethernet USB ports RS232 ports XVAC locking mechanism lower cal...

Page 41: ...ight Hooks and Tray Holders In addition to the storage area present in the cart the XTRA has three lateral hooks on the left side see Figure 3 4 These hooks are composed of an upper part designed to h...

Page 42: ...of the machine controls the locked unlocked state of the front wheels The back wheels have an independent brake pedal for each wheel The foot lever may be set in one of two positions Up position the...

Page 43: ...Figure 3 5 Transportability To allow transportability and simplify cleaning the XTRA cart can be removed from the XTRA body by means of two spring levers located on the lateral rear top area of the ca...

Page 44: ...gned to nest when they are collapsed for transport or storage As a result the height of the XTRA with the IV pole and reservoir pole fully collapsed is compact The IV pole and the reservoir are lifted...

Page 45: ...he XTRA control panel is mounted centrally at the top rear of the machine on a hinge that allows the screen to be rotated and tilted The control panel is protected to avoid problems from spills and si...

Page 46: ...e to the variability of the capacity speed ratio and the piping tolerance However these values must not be considered measured values but only reference values for the user Hematocrit indication The h...

Page 47: ...centrifuge housing light 4 The fluid loss sensor not visible in figure which detects fluid leakages in the centrifuge and stops the centrifuge and pump in case of a leak 5 The two RBC Buffy Coat sens...

Page 48: ...all times during processing and should be emptied and cleaned or replaced after drainage is collected If no drainage occurs it is not necessary to clean or replace the fluid container The Centrifuge W...

Page 49: ...when the clamp plunger is extended and totally occludes the tubing shutting off all fluid flow The clamps are electronically controlled and mechanically operated in the all operating modes If the mic...

Page 50: ...10 ml min increments Figure 3 16 Visible Parts of the XTRA Processing Pump The processing pump can be unfixed from its seat for cleaning purposes as described in Chapter 15 Maintenance Air Detector T...

Page 51: ...al waste products still present in the supernatant see Figure 3 18 XVAC Vacuum Module Option The XVAC is an optional vacuum module that can only be used as an accessory to the XTRA device It is integr...

Page 52: ...g instructions Figure 3 21 XVAC Control Panel Essential Performance Under the test conditions specified in IEC 60601 1 2 the XTRA is able to provide the essential performance and remain safe There are...

Page 53: ...RA Operator s Manual 20077 021 US 3 15 Disposable Description Figure 3 22 XTRA With Disposable Set Installed Front View 1 Blood collection reservoir 4 Wash solution 2 RBC bag 5 Waste bag 3 Anticoagula...

Page 54: ...S XTRA Operator s Manual Figure 3 23 XTRA With Disposable Set Installed Top View 1 Pump loop tubing 5 Tubing organizer 2 Tubing from pump to bowl 6 Bowl outlet port to Waste bag 3 Bowl inlet port from...

Page 55: ...Configurations Six configurations of the XTRA Collection Set are available XTRA Collection Set CARDIO with TOP reservoir XTRA Collection Set not CARDIO with TOP reservoir XTRA Collection Set CARDIO wi...

Page 56: ...port protector attached is designed to accept 1 4 inch 6 4 mm inside diameter tubing The three angled 45 blood inlet ports are designed to accept a 1 4 inch 6 4 mm slip fit connector Figure 3 26 Coll...

Page 57: ...end of the large bore tube is designed to be attached to a 1 4 inlet port on the XTRA blood collection reservoir The proximal end of the smaller bore tubing is connected to the anticoagulant solution...

Page 58: ...port on the blood collection reservoir and to the inlet port of the XVAC module or another vacuum source The vacuum pump creates the vacuum in the blood collection reservoir connected by means of the...

Page 59: ...see Figure 3 31 Figure 3 31 Bowl Set Tubing Organizer The tubing organizer consists of three color coded tubes mounted in the tubing organizer the pump loop cartridge the clear common tubing from the...

Page 60: ...ra and postoperative procedure Figure 3 32 Cross Section of Latham Centrifuge Bowl The conic sided design of the Rapid Latham bowl together with the double RBC detector system allows a superior separa...

Page 61: ...mulated waste volume The drain valve on the waste bag outlet port should be kept closed during processing The bag may be emptied by releasing the valve thus allowing the waste fluid to drain into a bu...

Page 62: ...ource for an additional secondary RBC bag line or for obtaining samples for quality assurance testing if necessary If the recovered red cells are to be reinfused to the patient from the secondary RBC...

Page 63: ...owl Procedure set with TOP reservoir and 175 ml bowl Procedure set with TOP reservoir and 225 ml bowl Procedure set with BOTTOM reservoir and 55 ml bowl Procedure set with BOTTOM reservoir and 125 ml...

Page 64: ...s prefer to postpone connecting the XTRA Bowl Set until a sufficient amount of blood has been aspirated Its use allows subsequent utilization of the Bowl Set at any moment of the surgery according to...

Page 65: ...t in its various surgical applications The following is a list of disposable sets that must be used with XTRA Catalogue No Product Designation Product Description 04250 Bowl Set X 55 XTRA Bowl Set wit...

Page 66: ...tion Reservoir TOP packed together with the accessory lines required to recover blood from the operating field The aspiration line allows transference of the blood aspirated from the operating field t...

Page 67: ...rate of 1 drop per second and adjusting accordingly In case of heavy bleeding appropriately increase the rate During blood recovery particularly when operating in the Automatic mode the operator shou...

Page 68: ...mately 200 ml of the anticoagulant solution CAUTION In the event of anticoagulant deficiency in collection reservoir due to inappropriate ratios the savaged blood may clot in the reservoir CAUTION Avo...

Page 69: ...8774 0 5m XTRA XVAC serial cable 41565 0 5m XTRA XVAC power cable 41531 4m power cable EU 41529 4m power cable USA 41560 4m power cable UK 41559 4m power cable IT Table 3 6 Accessories and optional pr...

Page 70: ...System Description 3 32 20077 021 US XTRA Operator s Manual...

Page 71: ...logous transfusion worthwhile Thus when setting up the XTRA for standby some operators prefer to postpone the connection of the XTRA Bowl Set until a sufficient amount of blood has been aspirated All...

Page 72: ...prudent to turn ON the machine before or while you install the disposables to ensure that it will be working properly when it is time to begin processing blood Supplies Required Blood Collection Rese...

Page 73: ...tional holder to be fixed to an IV pole in the proximity of the surgical field 1 Swing open the reservoir holder and raise it to the desired height see Figure 4 1 Figure 4 1 Raising the Reservoir Hold...

Page 74: ...d with a blue cap for a Blood Collection Reservoir TOP b located on the bottom of the reservoir for a Blood Collection Reservoir BOTTOM 6 Close the clamps on the Y adapter branches waiting for subsequ...

Page 75: ...ore tubing of the suction line 9 Attach the tubing to one of the inlet ports on the lid of the reservoir The inlet ports are orange capped 10 Hang the anticoagulant solution container on one of the ho...

Page 76: ...its built in control panel see Figure 3 21 In such cases you can turn on and control the level of aspiration directly from the XVAC control panel refer to Chapter 13 Vacuum Module for detailed informa...

Page 77: ...ine and open it 3 Open the centrifuge lid see Figure 4 5 Figure 4 5 Machine Top 4 Swing open the centrifuge arm see Figure 4 5 5 Unlatch and open the clamp lid see Figure 4 5 6 Remove the bowl tubing...

Page 78: ...emove the bowl and repeat installation Figure 4 7 Inserting the Bowl in Order to Avoid Wobbling 12 Line up the tubing so that the pump loop cartridge snaps into the notch provided and the organizer is...

Page 79: ...8 15 Make sure the waste line is properly seated into the waste fluid transparency indicator 16 Close the centrifuge lid 17 Connect the fill line blue to the outlet port of the reservoir covered with...

Page 80: ...r of fluid bags on the XTRA IV poles These configurations ensure that the XTRA remains stable under normal operating conditions Step 6 Hanging the Waste Bag 1 Remove the waste bag from the tray 2 Hang...

Page 81: ...ON The Waste bag must not be squeezed while treatment is being done and must have the space to fill up properly If the bag is squeezed or cannot fill up properly because it is positioned near an obsta...

Page 82: ...d remove it from the hangers on the side of the unit Note Any liquid present in the waste bag should be discarded according to the regulations in force in the country of use 12 Discard the disposable...

Page 83: ...nywhere within the button an action referred to as touching throughout this manual The button will appear momentarily depressed and then will perform its associated function Figure 5 1 Example of an E...

Page 84: ...on from left to right The triangle warning icon appears to the far left if any warnings have been disabled and or there are any changes to the acoustic signals The detected bowl size 55 ml 125 ml 175...

Page 85: ...ersely pressing the title bar of an open displet closes it Figure 5 5 shows the reservoir displet in first its open and then its closed state Whether a displet is opened or closed at wakeup can be con...

Page 86: ...esent the Waste Bag displet is located in the lower right corner of the displet area It displays the volume of fluid currently in the waste bag ml The Waste Bag displet is not visible when processing...

Page 87: ...30 seconds The up and down arrow buttons disappear and the text box returns to its original color The new parameter value has been set Note Every parameter has a maximum and minimum value and the int...

Page 88: ...ecting blood in the reservoir it is very important to monitor the rate at which the fluid enters the reservoir The operator must adjust the flow of anticoagulant solution to assure that the proper mix...

Page 89: ...t indicator is enabled it starts up the calibration of the Hct indicator with saline solution It unlocks the centrifuge lid Note If the Retain button is present and you wish to proceed with a case pre...

Page 90: ...s and the centrifuge begins accelerating Once the centrifuge reaches its target speed the pump will begin rotating and filling the bowl with blood from the reservoir The Fill phase like all processing...

Page 91: ...ced to the Wash phase automatically No manual intervention is necessary Note It is possible to manually switch phases while operating in the Automatic or 1 Touch modes by pausing the phase and using t...

Page 92: ...the pump and centrifuge will stop and processing will automatically continue to the Empty phase when operating with Pfat protocol the process will automatically continue to Fat Removal Wash subphase N...

Page 93: ...me Otherwise the Ready Screen is displayed From the Ready Screen to begin another processing cycle it is also possible to use a different protocol repeat the process from Step 1 on page 5 8 Ending the...

Page 94: ...Empty to manually switch to that phase The available phase buttons depend on the currently active phase Touching the Play button resumes processing from the point it was paused at and the button is re...

Page 95: ...aused during the Reservoir Empty warning and during the RBC bag Empty warning 3 Phase Buttons The phase buttons allow for the manual switching of phases While operating in Automatic or 1 Touch modes t...

Page 96: ...phase Automatic 1 Touch Fill Wash Intraoperative Empty phase Manual Preoperative Fill phase Automatic Conc Empty Preoperative Fill phase Manual Conc Preoperative Spill phase Automatic Conc Empty Preop...

Page 97: ...to the Ready screen without beginning a new case and it is impossible to continue the current case at the next system power on All buttons are disabled except the Stop button which can be used to int...

Page 98: ...e case data and any modifications to the protocols are retained in memory and may be resumed at the next power on To resume such an interrupted case perform the following actions 1 Switch on the syste...

Page 99: ...most likely warnings along with the appropriate response to each which can be triggered during a processing cycle For a complete description warnings and alarms refer to Chapter 14 Troubleshooting Re...

Page 100: ...Check that the tube going to the bowl is fully down in the air detector seat c Touch the Fill button to continue If the reservoir is empty and no more blood is expected in the reservoir a If the RBC b...

Page 101: ...phase is highlighted with a yellow outline and the phase is paused see Figure 5 24 Figure 5 24 Wash Bag Empty Warning If the wash bag is empty proceed as follows 1 Replace the wash bag 2 Touch the Pla...

Page 102: ...he Ready Screen will resume processing in the Wash phase rather than the Fill phase RBC Bag Full Figure 5 25 RBC Bag Full Warning The RBC Bag Full alarm is triggered at the end of the Empty phase if t...

Page 103: ...g button to resume 2 Otherwise if you want to empty the same bag use the drain at the bottom of the bag Do not empty below the minimum level Touch the Minimum Bag Level button to resume 3 Touch the St...

Page 104: ...nd collection of red cells the Post op protocol in a postoperative context allowing the use of the on board vacuum pump in its postoperative mode Note Only factory Post op and user protocols derived f...

Page 105: ...nning centrifuge bowl by use of the peristaltic pump Centrifugation concentrates the red blood cells into the bowl while supernatant components are expelled to a waste bag Next during the Wash phase a...

Page 106: ...until the buffy coat is detected 3 Once the buffy coat is detected by the RBC detector the pump is paused for a matter of seconds the exact time is determined by the bowl size in use 4 After the paus...

Page 107: ...e new speed 5 When air is detected in the line the bowl is presumed empty and the pump stops the empty clamp closes and the Ready screen is displayed on the touch screen Pstd The Pstd protocol is inte...

Page 108: ...he bowl from the saline solution 5 The pump begins to rotate counter clockwise The RBCs previously collected in the RBC bag and if present more RBCs from previous cycles are pumped back into the bowl...

Page 109: ...OFF when entering the Emergency Activation Screen They are mutually exclusive functions only one may be enabled When the Close button is touched the Emergency Activation Screen is closed without activ...

Page 110: ...the entire system during operation Unattended processing can lead to the development of problems with the operation of the system and or with the quality of the end product CAUTION During the executi...

Page 111: ...blood cells can lead to an excessive level of contaminants i e anticoagulants and plasma free hemoglobin in the treated blood CAUTION Use of the vacuum pump in INTRA mode while collecting blood postop...

Page 112: ...25 ml min 550 450 450 550 Final Fill Flowi 25 1000 25 ml min 250 Wash Flow 25 1000 25 ml min 50 100 250 450 500 Wash Volume 0 5000 100 ml 200 800 1000 1000 Fat removal Wash Flowi 25 1000 25 ml min 75...

Page 113: ...ed then Automatic mode behaves exactly like 1 Touch mode 1 Touch The 1 Touch operating mode is a shortcut to running the Automatic mode with both the Autostart and Continue functions enabled It is onl...

Page 114: ...page 5 11 for a description of each phase button The only ATS protocol which may be used in Manual mode is Pstd and any user defined protocols derived from it In Manual mode the Autostart and Continue...

Page 115: ...the system acts more like it is in a semi automatic mode When the end of the Fill phase is detected the system will stop the pump and prompt the operator to continue with the Fill phase by touching t...

Page 116: ...g The protocol and mode are selected from the Protocol Mode tab of the Menu Screen see Figure 5 33 For details about each protocol and operating mode refer to Factory Protocols on page 5 22 and The Op...

Page 117: ...ssing Screen to enter the Menu Screen 2 From the left side of the Menu Screen touch the Protocol Mode tab 3 Using the mode drop down menu at the top right of the Protocol Mode tab select the desired o...

Page 118: ...Screen If no errors are detected during the power up self test the operator will be prompted to check and confirm any disabled warnings or changes to default acoustic signals see Figure 5 34 If all wa...

Page 119: ...A green circle highlights the component in the diagram being tested and loaded during each step of the auto load process 3 Help Button Touching the help button from any screen will toggle the display...

Page 120: ...interrupted by pressing the Stop button touching the Start button resumes processing from the state the processing phase was in when it was stopped 2 Special Button Touching the Special button display...

Page 121: ...monitored and controlled The processing displet in the center of the screen changes during processing to present controls and information relevant to the current phase The title bar of the processing...

Page 122: ...s paused Pausing and resuming a cycle is discussed further in Pausing and Resuming the Cycle on page 5 11 Wash Screen The Wash Screen only appears during the Wash phase of intra and postoperative prot...

Page 123: ...Field The Hct Out field located in the processing displet displays the current hematocrit of the blood exiting the bowl The Hct Out field is not present while processing with PPP PRP sequestration pr...

Page 124: ...t Removal Wash status line The Fat Removal Wash status line consists of three elements from left to right the grey wash icon indicating the current phase a large text field which displays the current...

Page 125: ...en emptied from the bowl ml into the RBC bag during the current subphase Fat Removal Conc Figure 5 42 Fat Removal Conc processing screen 1 Fat Removal Conc status line The Fat Removal Conc status line...

Page 126: ...one has been selected using the Past Cases button The data in the tally table may be exported or printed using the Send Output button The table below shows which tally data is displayed for each prot...

Page 127: ...vent data Refer to Bowl tally on page 11 11 for a list of information included in reports when the Add Alarms Mods button is enabled This button is only enabled if Printer is selected from the drop do...

Page 128: ...D Tab of the Configuration Mode Screen To create modify and delete fields and to configure the list of values available via the drop down rapid selection menu for a field refer to Setting the Rapid Se...

Page 129: ...e drop down operating mode selection menu used to select the active operating mode Controls for any automated functions such as Autostart Continue RBC Detector and the Wash Empty functions which are a...

Page 130: ...fore loading the pump All changes made from the Settings tab take effect immediately The Anticoagulant ReservoirType and Vacuum settings affect only the current case Figure 5 46 Settings Tab of the Me...

Page 131: ...ous unconcluded treatment Having the vacuum mode setting available from the Settings tab before processing begins allows the operator to make a change in case it is started up in an undesired mode RBC...

Page 132: ...RBCs present in the empty line without unloading the pump loop tubing Touching the Empty button displays the message RBC line emptying at the top of the screen while the RBC line is being emptied 2 U...

Page 133: ...bottom of the Help Screen The rest of the screen contains context sensitive help for the screen from which it was invoked To close the Help Screen and return to the previously displayed screen touch...

Page 134: ...at case Touching a case in the past cases list selects it for viewing printing or saving When a case is selected it appears inset and green Touching the case a second time deselects it Multiple cases...

Page 135: ...owl tally data Refer to Bowl tally on page 11 11 for a list of information included in reports when the Add Bowl Tally button is enabled Add Alarms Mods Button Touch the Add Alarms Mods button to enab...

Page 136: ...uttons will be disabled and the text Outputting Case will be displayed on the Past Cases Screen View Case Button Touching the View Case button will display the Tally tab of the Menu screen with the ta...

Page 137: ...n during a processing phase will stop the pump rotor and centrifuge end the current cycle and then display the Ready Screen refer to Ready Screen on page 5 38 When resuming a processing phase with blo...

Page 138: ...the bottom of the handle with the groove in the pump rotor 9 Dismount the bowl and the rest of the disposable set 10 Close the centrifuge lid Note In case the power loss occurs before washing of the b...

Page 139: ...ol NO means the cycle is not available Enabling Purge and Prime IV Special Cycles The Purge and Prime IV features must be enabled in the Features tab of the Configuration Mode Screen before they will...

Page 140: ...ouching the Return button which is accessible from three places the Special Cycles Screen when the machine is stopped refer to The Special Cycles Screen on page 6 1 the button bar of the Fill phase wh...

Page 141: ...lable and can only be used if the RBC collection bag contains a sufficient volume of blood It is available regardless of the active operating mode or protocol The Concentrate cycle is initiated by tou...

Page 142: ...ounted in any tally data for the case The Prime IV cycle is initiated by touching the Prime IV button which is accessible from the Special Cycles Screen when the machine is stopped prior to the start...

Page 143: ...y paused The operator must touch the Play button to initiate the cycle Touching the Pause button will stop the pump rotor To resume the Prime IV cycle while paused touch the Play button Touching the C...

Page 144: ...centrifuge starts spinning at 5 600 RPM to prevent any air bubble formation from occurring during the Purge cycle and the Purge Screen is displayed see Figure 6 5 Figure 6 5 Purge Screen The Purge Scr...

Page 145: ...ssed blood can be reinfused by transferring the blood to the secondary RBC bag and closing the clamp between the two bags Blood can be stored for later reinfusion In this case follow your institution...

Page 146: ...e blood administration line 3 Clamp off a secondary RBC bag 4 Attach the second leg of the Y type blood administration set to one of the remaining ports of the secondary RBC bag 5 Close the primary cl...

Page 147: ...Blood Administration Set 1 2 3 4 5 6 7 9 10 1 Primary RBC Bag 6 Secondary Clamp 2 Primary Clamp 7 Y Type Blood Administration Set 3 Microaggregate Transfusion Filter 8 Y Type Blood Administration Set...

Page 148: ...Special Cycles 6 10 20077 021 US XTRA Operator s Manual...

Page 149: ...tional Automated Functions Some automated functions may only be initiated by the operator if they are enabled in the Features tab of the Configuration Mode Screen Refer to How to Enter the Configurati...

Page 150: ...Autostart target volume ml This is the volume of fluid which the reservoir must contain before the Autostart function initiates the cycle 5 Touch the Save Modifications button to make all changes in t...

Page 151: ...Autostart Disable button during the warning of the onset of automatic fill Automatically when the user selects a protocol or operating mode for which this automation is not allowed or is preset to it...

Page 152: ...Last Bowl Activation Screen is displayed prompting the operator to confirm activation of the Last Bowl function see Figure 7 2 Figure 7 2 Last Bowl Activation Screen Touching the Close button will cl...

Page 153: ...be interrupted in the following ways By pushing the Stop button By activating the Emergency function By switching to the Manual operating mode CAUTION The Concentration function reprocesses already co...

Page 154: ...or Pfat protocol It is available under every operating mode The BQW function is a protocol parameter that can be permanently stored in custom protocols so that unlike the other automations BQW activat...

Page 155: ...the modifications are not saved Refer also to Set the Active Protocol on page 5 35 The BQW function may be deactivated in the following ways Manually accessing the Protocol Mode tab of the Menu Scree...

Page 156: ...Automated Functions 7 8 20077 021 US XTRA Operator s Manual...

Page 157: ...type Reservoir type Vacuum mode Date and time These settings are described in The Settings Tab of the Menu Screen on page 8 2 The general configuration of the XTRA system consisting of the majority o...

Page 158: ...ttings tab is described in Settings Tab on page 5 48 Configuration Mode Most of the system settings may be changed from the password protected Configuration Mode Screen In all tabs a checked box indic...

Page 159: ...p of the Features tab refer to Setting the Enabled Features on page 8 4 to select one of the predefined feature sets Basic or Advanced or select Custom to create a custom configuration The part of the...

Page 160: ...tor to be available during processing such as for the Hct in and Hct out figures to appear on processing screens and be stored with the case data If the Hct indicator is disabled the Hct indicator wil...

Page 161: ...led the RBC detector option will be displayed in the Protocol Mode tab of the Menu Screen Note Automatic mode is available in every configuration and cannot be disabled Automated Functions The followi...

Page 162: ...check next to the protocol name indicates that it may be selected as the active processing protocol from the Protocol Mode tab of the Menu Screen The sequestration protocols are described in detail in...

Page 163: ...h mode is disabled in the Features tab then it will not be possible to set it as the wakeup mode here This setting does not affect the default mode for sequestration protocols which is always Automati...

Page 164: ...up and down arrow buttons to adjust the screen brightness until optimal display visibility is achieved Warnings Tab From the Warnings tab of the Configuration Mode Screen see Figure 8 7 it is possibl...

Page 165: ...ed signal composed of three short beeps Acoustic Signal The duration of several alarms may be configured individually using each alarm s two part toggle button under the Acoustic signal heading Long c...

Page 166: ...ng the Close button will return to the ID Tab without creating a new ID field Rename ID Field Touching the Rename ID Field button will display a QWERTY keyboard allowing the operator to rename the sel...

Page 167: ...he Edit Field List Screen contains the Items drop down menu Touching the triangle button will collapse and expand the list of items contained in the list Touching an item in the list will move it to t...

Page 168: ...e The setting takes immediate effect Reset Options In order to guarantee the protection of important data this Tab can be visualized only using a secondary password when entering the Configuration Mod...

Page 169: ...er the Configuration Mode on page 8 2 for instructions on entering the Configuration Mode Screen For more on configuring the XTRA system refer to the rest of Chapter 8 Configuring XTRA Creating Custom...

Page 170: ...all characters entered from the keyboard leaving the insert area blank Caps Numbers Button Touching the Caps Numbers on the Keyboard Screen button toggles the keyboard between showing capital letters...

Page 171: ...rue for sequestration protocols PPP PRP1 and PRP2 and their derived custom protocols Custom protocol names are prefixed with the name of their base factory protocol For example a custom protocol creat...

Page 172: ...nd emptying pump speed will cause an asterisk to appear next to the protocol s name as an indication to the operator that the protocol has been modified Additionally modifications to the Final Fill an...

Page 173: ...of each factory protocol or any custom protocol derived from it which may be modified from the Protocol Mode tab Each customizable parameter is briefly described in Protocol Area on page 9 8 If the s...

Page 174: ...g the pump loop Only one protocol per bowl size may be designated as a wakeup protocol Designating a new protocol will automatically cause the previous wakeup protocol to lose its designation It is po...

Page 175: ...utton Touching the Rename button displays the Keyboard Screen allowing the operator to rename the suffix portion of a custom protocol s name A factory protocol cannot be renamed Refer to Renaming a Pr...

Page 176: ...the bowl during the special Concentrate phase ml min Return Speed The speed at which the pump moves fluid from the bowl back into the reservoir during the special Return phase ml min The Better Qualit...

Page 177: ...The volume of PRP to spill during the Spill PRP sub phase ml Spill Centrifuge Speed The speed at which the centrifuge spins during the Spill phase RPM Mode Area The mode area contains the controls fo...

Page 178: ...Programmability Option 9 10 20077 021 US XTRA Operator s Manual...

Page 179: ...asma shall be used or applied before the patient leaves the operating room or clinical procedure area i i American Association of Blood Banks Standards for Perioperative Autologous Blood Collection an...

Page 180: ...hdrawn from the patient through routine hemodilution techniques and collected in a blood bag pre filled with citrate such as ACD A The volume of blood obtained is determined by the physician and is de...

Page 181: ...into collection bags prior to the preoperative sequestration process blood flows from the patient by gravity into collection bags These bags obtained from the blood bank contain citrate in a ratio of...

Page 182: ...ollowing warnings and cautions Catalogue No Product Designation Product Description 04015 Sequestration Set X The product is used for separation of Platelet Poor Plasma PPP and Platelet Rich Plasma PR...

Page 183: ...anding the bag over for reinfusion WARNING Do not reinfuse under pressure i e do not use a blood pressure cuff on the RBC or plasma PRP bags Reinfusion under pressure could lead to air embolism WARNIN...

Page 184: ...Suction Line on page 4 4 Step 3 Setup of the Vacuum Line on page 4 6 and Step 4 Installing the Bowl Set on page 4 7 2 Hang the Waste bag on the two lower hangers located on the right panel of the mach...

Page 185: ...ter Close the clamp on the second sequestration line as it is not used In PRP2 procedures connect the blood transfer bag for PPP collection to the sequestration line with the yellow clamp and the othe...

Page 186: ...ent sequestration protocol and operating mode Automatic or Manual The protocol may be selected only before the cycle is initiated The operating mode may be changed at any time during processing The pr...

Page 187: ...ent of problems with the operation of the system and or with the quality of the end product If the pump does not stop after the STOP button is pressed the operator must shut OFF the power WARNING Do n...

Page 188: ...load the pump loop tubing For a description of the steps taken during the auto load procedure refer to Loading the Pump Segment for a New Case on page 5 6 Processing a Cycle This section gives basic s...

Page 189: ...ste bag is closed the bowl and the second collection bag is closed 3 Perform the requested action If processing with the PPP or PRP2 protocols close the PRP orange clamp and waste bag white clamp line...

Page 190: ...3 Play Pause button Touching the Pause button pauses the processing cycle the pump is stopped the Pause button changes to the Play button and the word Paused flashes and a 5 00 minute countdown timer...

Page 191: ...en will stop the pump and display phase buttons in the button bar The operator may touch the appropriate phase button Spill or Empty to switch to that phase or touch the Play button to continue proces...

Page 192: ...cessing displet With the pump stopped the system enters a second automatic pause period to again compress the buffy coat and improve the blood sedimentation The message Automatic Pause Press Play butt...

Page 193: ...Empty cycle has been completed you may repeat the procedure as directed or terminate sequestration processing and convert the system for intraoperative blood recovery see Finishing Preoperative Separa...

Page 194: ...ecial Cycles Screen on page 6 1 from the button bar of the Fill or Spill phase when the machine is paused or when the Reservoir empty Bowl not filled warning occurs When the Concentrate cycle is initi...

Page 195: ...between the whole blood bag and the centrifuge bowl Also refer to Whole blood bag empty on page 14 22 When triggered the acoustic sequence is sounded if enabled the message Whole blood bag empty is di...

Page 196: ...ety level Also refer to PRP bag full Empty or replace it on page 14 18 When triggered the acoustic sequence is sounded if enabled the message PRP bag full Empty or replace it is displayed in the messa...

Page 197: ...ash solution Unclamp at least one line 8 If you are using a new reinfusion bag a Remove the cap from the reinfusion bag b Remove the cap from the tubing line and twist connect to the reinfusion bag c...

Page 198: ...the Menu Screen see Figure 10 12 Figure 10 12 Tally Tab of the Menu Screen PRP2 For a detailed explanation of the Tally tab of the Menu Screen read Tally Tab on page 5 44 The Tally tab of the Menu Scr...

Page 199: ...s PPP For the collection of platelet poor plasma only in the PPP bag PRP1 For the collection of both plasma and platelets in a single bag and PRP2 For the collection of platelet poor plasma in the PPP...

Page 200: ...ng the Final Fill sub phase the pump speed is decreased in order to increase the thickness of the buffy coat layer Modifications made by the operator to the pump speed during the Final Flow sub phase...

Page 201: ...he set speed until the set PPP spill volume is transferred to the bowl which causes an additional volume of PPP to spill into the PRP collection bag The second half of the Spill phase is the Spill PRP...

Page 202: ...00 10 ml min 20 50 50 60 Fill Centrifuge Speed ii ii These parameters Centrifuge Speed in the Fill and in Spill phases are related to each other Spill Centrifuge Speed must always be lower than Fill C...

Page 203: ...can be found in the section Running a Case With the XTRA System on page 5 5 When operating in Automatic mode the machine detects the end of each phase and advances to the next phase automatically When...

Page 204: ...row buttons Spill PRP Text Box The Spill PRP field and text box displays the target volume of PRP to spill during the PRP Spill sub phase The target spill volume may be modified by touching the text b...

Page 205: ...le operating in Automatic mode the Empty button is only visible while processing is paused it is always visible in Manual mode 6 Menu Button Touching the menu button will bring up the Menu Screen Vari...

Page 206: ...Preoperative Sequestration PPP and PRP 10 28 20077 021 US XTRA Operator s Manual...

Page 207: ...ng Data Download Option The various methods of data download must be enabled in the Features tab of the Configuration Mode Screen before they will be available for use Refer to How to Enter the Config...

Page 208: ...paper forward When lit the POWER LED indicates that the printer is receiving a power supply When lit the STATUS LED indicates that the printer is on Refer to Sending Tallies to the Printer on page 11...

Page 209: ...downloaded once processing of the case has completed The End of Case Screen which appears upon completion of processing for every case Refer to End of Case Screen on page 5 50 The Tally tab of the Men...

Page 210: ...enu if enabled To create modify and delete fields and to configure the list of values available via the drop down rapid selection menu for a field refer to Setting the Rapid Selection of ID on page 8...

Page 211: ...een without selecting a past case to view or export Re opening Past Cases It is possible to re open a past case which has been selected for viewing for further processing To do so touch the Reopen Cas...

Page 212: ...11 5 2 Touch the Send Output button 3 While the case data is being printed the text Outputting case is displayed above the Send Output button and the Send Output button will appear inset and green Pr...

Page 213: ...1 Ensure that the serial cable is connected an RS232 port on the rear panel of the XTRA system 2 Select RS232 as the output destination following the procedure in Selecting the Output Device for Data...

Page 214: ...the case data is being saved the text Outputting case is displayed above the Send Output button and the Send Output button will appear inset and green Transferring Data From Past Cases 1 Start the dat...

Page 215: ...information included in reports when the Add Bowl Tally button is enabled Add Alarms Mods Button Touch the Add Alarms Mods button to enable the inclusion of event data such as alarms and modification...

Page 216: ...al RBCs collected ml Total PPP collected ml Total PRP collected ml Date and time of the start of the first Fill phase Date and time of the end of the last Empty phase Total number of cycles Total volu...

Page 217: ...me ml Initial Spill PRP volume ml Initial Wash volume ml Initial vacuum status Initial BQW status Off 2X 4X Initial Autostart status Initial Continue status On Off Initial Return flow speed ml min Ini...

Page 218: ...ble parameter change during each cycle the following data is recorded to the system s internal memory and may be exported using one of the data download options Event type and ID Timestamp New value f...

Page 219: ...ndicator calculates the removal of supernatant during the Wash phase Figure 12 1 Location of the Hct and WLC Indicators Together these indicators and the user interface elements associated with them o...

Page 220: ...ll display an Hct In and Hct Out fields respectively containing the Hct of the fluid entering or of the RBCs leaving the bowl The Hct In field is also displayed during the Concentrate cycle The tally...

Page 221: ...ted with the supernatant removal indicator nor the calculated information will be available unless the Supernatant Removal feature is enabled from the Configuration Mode Screen refer to Enabling Quali...

Page 222: ...hed by the time the Wash phase has completed the system will issue the following warning and continue in the Wash phase Minimum wash quality might be not reached yet The machine will then continue in...

Page 223: ...screen user interface The XVAC vacuum module can be controlled using its built in control panel only when the touch screen user interface of XTRA is not available in the following two cases 1 When th...

Page 224: ...module was last used The wakeup operating mode and setpoint values are determined as follows If the XTRA system has no wakeup protocol set or if it was powered down in the middle of a case then the XV...

Page 225: ...ng Reservoir to Inlet Port Performing a Blood Collection Procedure With the XVAC Module XVAC Used Through the XTRA System Touch Screen Interface Remote Control The XVAC vacuum module may be used in co...

Page 226: ...in machine the operator may operate the vacuum module using the XVAC control panel while the rest of the XTRA system powers on During this time XVAC will show the not linked icon on the right side of...

Page 227: ...o Set the Active Protocol on page 5 35 for instructions on changing the active operating protocol When the current protocol changes for example from Pstd to Popt the system will communicate to the XVA...

Page 228: ...on off button will toggle the vacuum pump on and off when it is operating in local control The current state of the vacuum pump is indicated by the green vacuum status LED light ON dark OFF Vacuum Lev...

Page 229: ...quickly change the set point The current set point is shown on the LCD display 4 Once the set point has been adjusted start the pump by pressing the vacuum pump On Off button The green vacuum status...

Page 230: ...he EEPROM failure alarm F11 occurs due to the failure of calibration coefficients test the system automatically repairs the problem by overwriting the wrong coefficients with a default set of coeffici...

Page 231: ...iately after the prelink phase the XTRA user interface displays the message Vacuum pump out of order The XTRA system will continue working as if the XVAC module were absent When an alarm occurs during...

Page 232: ...Vacuum Module 13 10 20077 021 US XTRA Operator s Manual...

Page 233: ...se When an alarm or warning is issued the system enters a safe state corresponding to the stopped Ready Screen the pump and centrifuge are halted the clamps closed and the lid lock opened Alarms and W...

Page 234: ...Audible Alert In addition to the visual alert warnings and alarms are accompanied by an audible alert As a general rule alarms warnings related to checks performed immediately after the operator perfo...

Page 235: ...bility under his own responsibility therefore directly managing those controls Message Text Warning or Alarm Buttons Available in the Button Bar During Warning Alarm Operator Response Data Management...

Page 236: ...problem persists call the authorized technical service Check centr arm closure Check centrifuge lid lock Warning The centrifuge lid lock is malfunctioning Press X to restore Lock position then close t...

Page 237: ...hardware anomaly was detected while testing the Fill clamp Fill clamp test failed HCT indicator calibration failed Warning The machine cannot calibrate the HCT indicator Verify that the line is proper...

Page 238: ...hen press RETAIN Make sure to do this before pressing the LOAD PUMP button HCT calib connect saline Inconsistent vacuum mode Warning The vacuum pump is set on a different mode vs the one required by t...

Page 239: ...rotate it might be missing or not seated correctly 1 Open the centrifuge lid and check the position of the pump rotor open the white lever push the pump rotor fully down turn the pump rotor to align t...

Page 240: ...ODE If enabled If so press STOP enter the MENU screen and from the PROTOCOL MODE tab set the protocol to Pstd and switch to MANUAL MODE You may decide to disable the alarm for the current case by pres...

Page 241: ...If the bowl is sufficiently packed with RBCs you may decide to press 2xWASH to proceed to the Wash phase using twice the saline solution volume WARNING Inadequate filling may lead to lower than expect...

Page 242: ...n spillage of blood into the waste bag Reduce pump speed if necessary Press EMPTY to resume the Empty phase Press X to exit and display the ready screen WARNING Repeating the bowl emptying several tim...

Page 243: ...AT REM to confirm the Fat Removal phase Wash phase shall be not completed WARNING Inadequate washing of packed red blood cells may lead to an excessive level of contaminants e g anticoagulant plasma f...

Page 244: ...expected hematocrit and removal of waste components c Press EMPTY to confirm the Empty phase WARNING Inadequate washing of packed red blood cells may lead to an excessive level of contaminants e g ant...

Page 245: ...l not filled washed Bowl should be empty Warning The air sensor could be faulty The volume emptied from the bowl is higher than expected Press PLAY to resume WARNING Repeating the bowl emptying severa...

Page 246: ...fer to Chapter 10 Preoperative Sequestration PPP and PRP Close PPP line open PRP line Then press PLAY Instructional Message Follow the on screen instructions Refer to Chapter 10 Preoperative Sequestra...

Page 247: ...nt phase You may decide to disable the sensor and the related alarm for the current case by pressing DISABLE ALARM If the problem persists call the authorized technical service Empty line occluded Flu...

Page 248: ...ble the sensor and the related alarm for the current case by pressing DISABLE ALARM If the problem persists call the authorized technical service Fluid loss in centrifuge Inconsistent vacuum mode Warn...

Page 249: ...age and display the Wash screen If the waste line is clear you may decide to anticipate the Fat Removal phase by pressing FAT REM Otherwise the device will continue to wash for the entire preset wash...

Page 250: ...LAY to resume The bag volume counter will be reset to Zero WARNING Not following these instructions may expose the operator to biohazard risk and compromise the current case PPP bag full Process quick...

Page 251: ...or occluded Remove the occlusion and press PLAY to resume The RBC bag might be empty The spill phase cannot be started if the bowl has not been properly filled with RBCs If you intend to proceed conne...

Page 252: ...l is sufficiently packed with RBCs you may decide to press WASH to proceed to the Wash phase or 2XWASH to use twice the saline solution WARNING Inadequate filling may lead to lower than expected hemat...

Page 253: ...to resume WARNING The waste bag should be replaced with the equipment STOPPED and the bowl completely empty If you want to use the same bag empty it to the minimum level using the drain at the bottom...

Page 254: ...he whole blood bag might be empty The spill phase cannot be started if the bowl has not been properly filled with RBCs in PRP1 and PRP2 If you intend to continue the sequestration connect a new whole...

Page 255: ...d touch the Retain button Centrifuge Failure E20 E55 E56 E57 E58 E59 Switch the machine OFF Make sure the bowl is properly seated inside the centrifuge and the centrifuge arm is locked Check the corre...

Page 256: ...31 E32 E39 Switch the machine OFF Wait a few seconds switch the machine on and touch the Retain button Electronic Failure NMC Board Overtemperature E23 Switch the machine OFF Wait a few minutes to all...

Page 257: ...e of incompatible IV fluids or topical hemostats 3 Decreased patient Antithrombin III levels 1 Monitor anticoagulant ratio more closely 2 Avoid use of Ringer s when using citrate anticoagulant Do not...

Page 258: ...ical management of patient to assess the need for replacing clotting factors 3 Avoid processing partially filled centrifuge bowls use at least one liter during the Wash cycle Check anticoagulant flow...

Page 259: ...emolysis 1 Use of hypo or hypertonic IV solutions 2 Improper sampling techniques 3 Hemolytic substances introduced into surgical wound 1 Use only isotonic normal saline 2 Do not aspirate from the RBC...

Page 260: ...Troubleshooting 14 28 20077 021 US XTRA Operator s Manual...

Page 261: ...vice technicians and other testing entities To maintain the basic safety and essential performance all requirements concerning the electromagnetic compatibility described in appendix A must be complie...

Page 262: ...ntire length of the cable cracks cuts clearly visible kinks Figure 15 1 Power Supply Cable A Serial Cable and Vacuum Pump Power Supply B If any of the above cables are found damaged replace it Have th...

Page 263: ...e Suitable cleaning products are commercially available pre packaged for use Use of incorrect cleaners can result in optical impairment of touch panel and or damage to functionality Note Most products...

Page 264: ...External Surfaces on page 15 2 Centrifuge Well Swing open the centrifuge arm see Figure 15 3 and clean the well following the indications reported in section External Surfaces on page 15 2 Figure 15 3...

Page 265: ...the disassembled parts of the overflow trap Figure 15 5 Composition of the Overflow Trap After removing the trap from the XVAC do the following 1 Unscrew the jar from the cap 2 Remove the float from...

Page 266: ...ocated on Machine Top List of Operator Replaceable Parts Some parts for the XTRA may be replaced directly by the operator and do not require installation by a service technician The following parts ar...

Page 267: ...e rotor by closing the lever see 2 in Figure 15 7 Paper Replacement When the paper roll is almost empty vertical pink striped lines starting approximately 8 feet from the end of the roll will appear o...

Page 268: ...stic ribbon cartridge Note If necessary press the FEED button to feed the paper forward 5 Snap the ribbon in place 6 Use the paper advance button to advance about 2 inches of paper out of the printer...

Page 269: ...exists Regardless of whether there is a service contract or not the XTRA must be subjected to a regular maintenance check by the authorized service technician in accordance with the European Directiv...

Page 270: ...Maintenance 15 10 20077 021 US XTRA Operator s Manual...

Page 271: ...it weight 37 kg Cart weight 22 5 kg Display Type graphic color LCD TFT 8 4 Dimensions 172 mm x 130 mm screen Keyboard 1 STOP key Touch screen keys Mains voltage Power supply 230 V or 100 120 V Frequen...

Page 272: ...l Position waste line Range 0 3000 mg dl Waste bag level Type Software Intervention Range 7 10 l RBC sensor or Buffy Coat sensor Low optical linear CCD High punctual optical Clamped empty line sensor...

Page 273: ...of the devices is in no way altered by maintenance and or repair activities performed by its engineers b In the event of a formal request being made for servicing at the Buyer s premises by LivaNova p...

Page 274: ...d to the user shall be considered as confidential and as belonging exclusively to LivaNova These shall not therefore be revealed distributed copied or reproduced by any means and for whatever purpose...

Page 275: ...ndergoes safety tests as prescribed by the relevant standard IEC 60601 1 the results of which are available from LivaNova d Any requests for specific measurements of safety parameters different from t...

Page 276: ...pulously observe all the aforementioned provisions please feel free to contact LivaNova or the authorized LivaNova representative for any further details and or technical assistance you might require...

Page 277: ...mission The XTRA is intended for use in the professional healthcare facility environment specified below In order to prevent adverse advents to the patient and operator due to electromagnetic disturba...

Page 278: ...nment Furthermore the XTRA must not be operated if the enclosure cables or measures for electromagnetic shielding are damaged Phenomenon Basic EMC standard or test method IMMUNITY TEST LEVELS Professi...

Page 279: ...Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse modulation 217 Hz 0 2 0 3 9 5500 5785 Note If necessary to achieve the immunity...

Page 280: ...s between 0 15 MHz and 80 MHz 80 AM at 1 kHz Voltage dips IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 Voltage interruptions I...

Page 281: ...surgical devices this can lead to EMC interference and must therefore be observed with increased attention The indications for use for the device are still valid Technical description Use of accessor...

Page 282: ...A 6 20077 021 US XTRA Operator s Manual...

Page 283: ...EMC Standards See Appendix A Safety Standards EN 60601 1 2 EMC Emission IEC 60601 1 2 2007 and 2014 EMC Immunity IEC 60601 1 2 2007 and 2014 Electrical and Mechanical Safety Standards IEC 60601 1 Edi...

Page 284: ...B 2 20077 021 US XTRA Operator s Manual...

Page 285: ...a complete setup and use of the machine please refer to the XTRA Operator s Manual These documents may be printed as standalone documents preferably color and double sided Contents Setting Up the Disp...

Page 286: ...C 2 20077 021 US XTRA Operator s Manual...

Page 287: ...reservoir lid into the slot of the holder 1 Install the Blood Collection Reservoir e Push the reservoir into position 1 Install the Blood Collection Reservoir f Release the locking clip 1 Install the...

Page 288: ...ion line from its package and carefully open the outer wrap 2 Connect the Suction Line d Pass the inner sterile wrapped assembly to the sterile field At the sterile field unwrap the assembly remove th...

Page 289: ...aspiration tip is open to the atmosphere not blocked 3 Set up the Vacuum Line d With the XVAC system ON open the roller clamp on the small bore tubing and allow 200 ml of anticoagulant solution to be...

Page 290: ...nstall the Bowl Set j Line up the tubing so that the pump loop cartridge snaps into the notch provided and the organizer is properly seated 4 Install the Bowl Set k Make sure that the tubing is correc...

Page 291: ...to the Saline solution Containers c Close the slide clamp of one of the two yellow wash lines when using only one bag of saline solution 5 Connect Wash Lines to the Saline solution Containers d Using...

Page 292: ...e without selecting a protocol from the list will close the Protocol menu without changing the active protocol 4 Perform the following to set the active operating mode from the Protocol Mode tab a Tou...

Page 293: ...tocols Mode tab from the left of the Menu Screen set the active protocol to an ATS protocol set the mode to 1 Touch or Automatic and ensure the Autostart and Continue automations are enabled 4 Once re...

Page 294: ...e mode to Automatic 4 Once ready touch the Start button A to begin processing 5 Follow the on screen instructions clamp the PRP and waste bag lines open the PPP line and then touch the Play button A T...

Page 295: ...the New button A This will duplicate the selected protocol and will give the newly created protocol a unique name prefixed by the base protocol s factory type 5 Touch the Rename button A to display t...

Page 296: ...any processing screen touch the Menu button A to enter the Menu Screen 2 From the Tally tab check to see if Printer is set as the current destination in the destination drop down menu A 3 If Printer...

Page 297: ...Blood Collection Reservoir Holder Code 04272 is mounted on XTRA the device can be moved only after all bags are removed from IV poles Mounted to upper IV pole liters Mounted to lower IV pole liters Mo...

Page 298: ...D 2 20077 021 US XTRA Operator s Manual...

Page 299: ...nst electrical shock as defined in that standard Applied part is the fluid circuit from the tube Main switch primary O off not connected to mains I on connected to mains External fuse replaceable Tabl...

Page 300: ...l Number Keep dry Keep out of precipitation CAUTION Centrifuge plate operating at 5600 RPM in counterclockwise direction Raise the lever to unlock the IV pole Date of manufacture Manufactured by Use o...

Page 301: ...ey stops the pumps centrifuge and automatic processing No Pushing Protection Class I Only applies in the U S A Sale and prescription is restricted to physicians 1 pound 453 6 g 1 mm 0 039 in 1 bar 15...

Page 302: ...E 4 20077 021 US XTRA Operator s Manual...

Page 303: ...ical device bears the marking according to the European Council Directive MDD 93 42 EEC Further information is available from Manufacturer contact LivaNova s local Representative or directly LivaNova...

Page 304: ...LivaNova Deutschland GmbH Lindberghstrasse 25 D 80939 M nchen Germany Tel 49 0 89 32301 0 Fax 49 0 89 32301 555...

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