Haemonetics Cell Saver Elite+ User Manual Download

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Haemonetics

Cell Saver

Elite

+ User Manual

P/N 130859-US, Manual Revision: AA

Appendix A

IEC/EN 60601-1-2 Standard

Requirements

Operation Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .216
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .217

Summary of Contents for Cell Saver Elite+

Page 1: ...User Manual Not for use with software prior to revision AQ 130859 US AA October 2022...

Page 2: ...ovided or recommended by Haemonetics could result in impaired product function injury to the user or others or void applicable product warranties Haemonetics accepts no responsibility for liability re...

Page 3: ...omed and should be forwarded to the attention of Rx Only Caution USA Federal Law restricts the sale distribution or use of this device to by or on the order of a licensed healthcare practitioner Note...

Page 4: ......

Page 5: ...17 Symbols Found on the Device 17 Device Specifications 20 Device Classification 20 Physical Specifications 20 Environmental Specifications 20 Electrical Specifications 21 Laser Specifications 22 Ord...

Page 6: ...ep Plate 48 Removable Bins 48 Chapter 3 Disposable Components Description Overview 50 Reservoir 51 The A A Line and Post Op Set 52 A A Line 52 Post Op Set 52 Vacuum Line 53 Processing Set Elements 54...

Page 7: ...4 Positioning the Device 74 Unfolding the Biohazard Waste Bag 75 Power on Procedure 76 Installing the Cell Salvage Components 77 Inspecting the Disposable Components 77 Collect First Setup 77 Installi...

Page 8: ...Blood Bags 112 Initiating a Procedure 112 Collecting PPP 113 Collecting PRP 115 Emptying the Bowl 116 Concentration During Sequestration 116 Ending the Sequestration Protocol Early 117 Changing to a...

Page 9: ...the Device 157 Replacing the Biohazard Waste Bag 159 Cleaning the Optical Lenses 159 Cleaning the Centrifuge Well 159 Cleaning the Fluid Detector 160 Cleaning the Pump 160 Washing Replacing the Air Fi...

Page 10: ...of Contents P N 130859 US Manual Revision AA Haemonetics Cell Saver Elite User Manual Appendix B System Performance Cell Salvage 224 Appendix C Cart Assembly Instructions Installing the Device on the...

Page 11: ...2 Indications for Use 12 Essential Performance 13 Contraindications 13 Features of the Cell Saver Elite System 13 Performance Characteristics 14 Blood Product Quality 16 Symbols 17 Symbols Found in Th...

Page 12: ...BCs and then washed to remove cell stroma platelets activated clotting factors extracellular potassium free hemoglobin anticoagulant and cardioplegia The washed packed RBCs are then pumped to a reinfu...

Page 13: ...ologists and transfusion medicine specialists involved in the patient s care The use of reinfused blood from the Cell Saver Elite system may be contraindicated for example in the case of sepsis or mal...

Page 14: ...f the essence Quick Transfer Mode can be used to quickly move shed blood from the reservoir to the reinfusion bag and bypass the wash phase completely Final Cycle Enables users to specify the End Proc...

Page 15: ...ed 25 mL to 1000 mL 10 Reservoir Level Up to 3 kg 25 g Waste Bag Scale Up to 10 L 250 mL Table 4 Cell Savage Protocol 70 mL Bowl Characteristic Value Centrifuge Speed Fill Wash 7500 RPM 300 RPM Centri...

Page 16: ...h with and without lysate Mean values are reported alongside standard error of the mean Results may vary depending on in use variables See Appendix B System Performance for complete blood quality perf...

Page 17: ...e user against initiating an action or creating a situation which could result in serious personal injury to the patient or user Warning Notifies the user of an electric shock risk Caution Notifies th...

Page 18: ...ips leaks and spills Manufacturer Maximum safe working load Alternating current Fuse Equipotentiality Identifies the terminals which when connected together bring the various parts of a system to the...

Page 19: ...rocess Applicable only to those products or materials for which at the end of life there is a well defined collection route and recycling process and which does not significantly impair the effectiven...

Page 20: ...e as follows The noise level of the Cell Saver Elite device is 70 dB Environmental Specifications The following environmental conditions should be respected pertaining to operation and storage of the...

Page 21: ...er source used must be properly grounded In accordance with IEC EN 60601 1standard medical electrical equipment general requirements for safety Table 9 Environmental Specifications Conditions Values A...

Page 22: ...le 12 Laser Specifications Characteristics Values Max radiation output 3 mW Wavelength 650 nm Max light output 7 mW bowl optics 1 7 mW 0 2 mW barcode reader Standards IEC EN 60825 1a 21 CFR 1040 10 an...

Page 23: ...r Case Waste Bag 10 L CSE B 1000 10 Cell Saver Elite fastpack 225 mL 20 CSE FP 225F 4 Cell Saver Elite fastpack 125 mL 150 CSE FP 125V 4 Cell Saver Elite fastpack 225 mL 150 CSE FP 225V 4 Cell Saver E...

Page 24: ...rain bag 35643 00 Wheel 4 in locking antistatic 124282 01 Wheel 4 in locking 124282 02 Air exhaust filter cover 100875 00 Air exhaust filter 100878 00 Knob for touch screen mount and reservoir weigher...

Page 25: ...Filter 31 Touch Screen Storage Mount 31 Vacuum Connection 31 Touch Screen Cable Entry 32 Equipotential Ground Terminal Connection 32 Reservoir Weigher Connection 32 Power Entry Module 32 Power Cord 32...

Page 26: ...Side panel Rear panel Touch screen Cart Note Any references made to left right top or rear are from the perspective of a user facing the Cell Saver Elite device during a procedure Figure 1 Cell Saver...

Page 27: ...tion Air Detector The ultrasonic air detector monitors the fluid flow in the pump tubing During the Fill phase the air detector senses air when the reservoir is empty During the Concentrate Conc phase...

Page 28: ...ssure sensor monitors pressure levels in the blue and red lines during Empty and Return and in the yellow line during Wash If the clamp on the RBC bag collection bag reservoir or yellow line is inadve...

Page 29: ...Detector The fluid detector is an electronic fluid detection device mounted on the wall of the centrifuge well The fluid detector detects the presence of liquid in the event of a bowl leak Centrifuge...

Page 30: ...the rotating part of the bowl during a procedure A centrifuge drain port underneath the chuck allows blood to drain into a biohazard waste bag in the event of a bowl leak Header Arm The centrifuge he...

Page 31: ...ilter The air exhaust filter is a replaceable antibacterial filter through which externally vented exhaust from the SmartSuction system passes Touch Screen Storage Mount The touch screen storage mount...

Page 32: ...at connects the device with the reservoir weigher Power Entry Module The power entry module contains the power cord connection ON OFF switch and the main fuse holder Power Cord A power cord is supplie...

Page 33: ...low when user intervention is needed and red when the procedure is stopped There are corresponding color coded alert bars on the status indicator page 35 and the message area page 39 Barcode Reader Ca...

Page 34: ...se pad When the device is stopped in the Prime or Fill phase double pressing the Stop key puts the device into Standby mode Touch Screen Mount The touch screen mount allows the user to move the touch...

Page 35: ...Status Indicator The status indicator displays the current status of the device Figure 7 Example of the status indicator when the Fill phase is paused This includes Phase mode The center area shows th...

Page 36: ...er air flow rates indicating submergence in fluid Note Efficient operation of the SmartSuction technology depends on the use of a high air flow disposable vacuum line and aspiration and anticoagulant...

Page 37: ...the configurable settings the Sequestration protocol and other options The menu options include Cell Salvage Sequestration only available prior to starting the Cell Salvage protocol Settings Records S...

Page 38: ...resume the procedure Grayed The pad is disabled During the Wash phase the Wash pad expands to show the wash volume used and the target wash volume Figure 12 Example of the Wash pad during the Wash ph...

Page 39: ...ssages are color coded to show the alert state of the device and there is a corresponding status beacon on the top of the display screen See page 33 Green indicates normal yellow indicates that user i...

Page 40: ...ters can be adjusted during a procedure using the pump control pads To immediately stop the pumps touch Pause To restart the current phase touch Play or to start a different phase touch the correspond...

Page 41: ...d processed volume of saline used and volume of RBCs added to the RBC bag Device Cover Lock Indicator The device cover lock indicator appears at the lower right of the procedure diagram and indicates...

Page 42: ...the device will remain in the Fill phase until you touch Wash to transition from the Fill phase to the Wash phase Effluent Sensor Disabled This icon appears if there has been a line sensor failure an...

Page 43: ...if the device enters the Empty phase without executing a Wash phase Alert The cells currently moving to the RBC bag have not been washed Wash Quality Unchecked This icon appears after starting the Emp...

Page 44: ...ck Transfer and Manual Mode Settings Available on page 136 for more information Volume Pad Figure 20 Stages of the Volume pad The Volume pad controls the audible signal that sounds for any notices war...

Page 45: ...s are password protected with three different levels of access basic user administrator and Haemonetics technician To unlock the System screen touch Unlock enter your password and touch Accept The dev...

Page 46: ...nd show hide select fields Export Settings Export all settings to a USB flash drive Software Update View available software versions Import Settings Select settings to import from a USB flash drive Ne...

Page 47: ...uch screen and the right IV pole contains the reservoir weigher Both poles can be easily lowered and locked in the down position for ease of transport Device Mount The device mount is the flat plate t...

Page 48: ...t occurs will not count towards the volume of the reservoir Note The reservoir weigher ships with the Cell Saver Elite device but gets mounted on the cart as shown in Figure 1 on page 26 Saline Hanger...

Page 49: ...Manual Revision AA Chapter 3 Disposable Components Description Overview 50 Reservoir 51 The A A Line and Post Op Set 52 A A Line 52 Post Op Set 52 Vacuum Line 53 Processing Set Elements 54 Tubing Harn...

Page 50: ...e components to collect blood salvaged during a procedure Each disposable component is individually packaged in a sealed plastic tub or wrapping The following disposable components are available Reser...

Page 51: ...field The top of the reservoir contains a vacuum connection and three filtered inlet ports for A A line and post op suction set connections The reservoir also has a drain port on the bottom and an int...

Page 52: ...reservoir that has a maximum capacity of 3 liters The Cell Saver Elite device has been calibrated to optimize SmartSuction performance with the use of Haemonetics proprietary disposable sets and reco...

Page 53: ...performance and damage the device The single use filtered vacuum line connects the vacuum port on the rear panel of the device to the vacuum port of the reservoir The vacuum line contains an in line h...

Page 54: ...ttaches to the RBC bag The tubing manifold holds the tubing in place in the pump module and holds the clear tubing going to the centrifuge All three color coded lines pass through the pinch valves in...

Page 55: ...aste bag make sure the bowl is empty If the bowl is not empty return its contents to the reservoir replace the waste bag and process again RBC Bag The 1L RBC bag holds the processed red cells for rein...

Page 56: ...owl sizes Centrifuge Chuck Adaptor Alert Do not grease any part of the centrifuge or centrifuge chuck adaptor If grease has been applied to the chuck contact the Haemonetics hotline immediately The 70...

Page 57: ...to the red line of the processing set At the end of Sequestration the user removes the upper portion of the blood bag adaptor harness using the twist lock connector Collection bag harness the collect...

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Page 59: ...nt Control 63 Power Outlet Connection 63 Laser Radiation Hazards 63 Mechanical Hazards Rotating Parts 63 Communicable Disease Precautions 64 Preventing Problems During a Procedure 65 Understanding the...

Page 60: ...d to as the first in first out FIFO technique All disposable components should be stored in a dry well ventilated area free from exposure to chemical vapors Many plastic components are sensitive to ch...

Page 61: ...do so could result in injury or damage to the device Use the wheel locks when the system is parked Alert Use caution when going up or down ramps Do not park the cart on a ramp Transporting a Device wi...

Page 62: ...lly lift the device off the cart Figure 32 Removing the device from the cart Installing the Device on the Cart Follow the steps below to install the device on the cart 1 Flip down the quick release le...

Page 63: ...ent and ground continuity before leaving the factory Power Outlet Connection A power cord is supplied with the device Do not replace the power cord with a substitute If necessary contact the Haemoneti...

Page 64: ...n contact with the blood contaminated components Proper Handling of Blood Contaminated Components If a leak or blood spill should occur it should be cleaned immediately The user should follow the loca...

Page 65: ...ter the effluent line sensor check has been passed Since the presence of free hemoglobin in the RBC bag may not be readily apparent the user should monitor for other indications of abnormal operation...

Page 66: ...subsequently lead to hemolysis and make any blood being processed unsafe for reinfusion During operation the user should interrupt the procedure if an abnormality or noise related to the spinning bow...

Page 67: ...ics recommends the Wash speed be at least 25 mL min lower than the Fill speed for the 125 mL and 225 mL bowls This ensures the cells are packed more forcefully during Wash and therefore less likely to...

Page 68: ...tory of Air The disposable bowl as received from the factory is full of sterile air During each fill cycle this sterile air is expelled into the waste bag while the bowl is filling and is returned fro...

Page 69: ...s and are already at room temperature The blue line is primed at the factory with sterile air During the first empty cycle this sterile air is sent into the reinfusion bag Therefore the contents of th...

Page 70: ...ABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma Using Anticoagulants Anticoagulant solutions are added to salvaged blood to keep it from clotting Different anticoagulants affect...

Page 71: ...time during each procedure without compromising the final product Any changes made to the preset processing parameters should be carefully considered prior to being executed Sequestration Typical proc...

Page 72: ......

Page 73: ...line Solution 83 Inspecting the Installation 83 Performing the Intraoperative Cell Salvage Procedure 84 Initiating a Procedure 84 Procedure Overview 84 Cell Salvage Additional Functions 85 Processing...

Page 74: ...wer source Warning Ground continuity can only be achieved when the equipment is connected to a properly grounded outlet Note The Cell Saver Elite device is classified as a continuous operation Class I...

Page 75: ...nnected to the drain tube attached to the underside of the device 3 Ensure that there are no kinks or twists in the tubing and allow the bag and its tubing to hang from the drain tube See Figure 34 4...

Page 76: ...to the Bowl Selection Screen Note During the power on self tests POST the device checks the interlocks for the device and manifold covers the centrifuge arm and the pump platen To avoid event message...

Page 77: ...set To prepare the collection reservoir and aspiration and anticoagulation A A line Load the Reservoir and Vacuum Line 1 Place the reservoir in the reservoir weigher or cardiotomy bracket so that the...

Page 78: ...e roller clamp on the anticoagulant line Citrate solution can also be used as an anticoagulant solution A general guide for citrate solution delivery is a ratio between 1 5 and 1 10 anticoagulant to b...

Page 79: ...blood recovery has occurred or is expected prepare the processing set for installation Selecting the Bowl Size 1 From the Bowl Selection screen scan a processing set using the barcode reader undernea...

Page 80: ...it lightly into place 5 Floss the tubing into the air detector 6 Insert the clear tubing and the color coded lines into the grooves in the valve module 7 Close the pump platen 8 Close and latch the v...

Page 81: ...Note A click will be heard when the locking mechanism is completely secured Alert Verify that the outlet port and effluent tubing are free of any restrictions prior to initiating a procedure If the ou...

Page 82: ...ine 3 Ensure that the waste bag drain port is completely closed Figure 40 Hanging the waste bag Connecting the Reservoir 1 Aseptically connect the red line to the reservoir drain port 2 Open the reser...

Page 83: ...owl in use By default the minimum amount of saline solution used for each bowl size is as follows these amounts can be increased or decreased by modifying the settings as described in Chapter 7 Protoc...

Page 84: ...phase when the bowl contains the appropriate amount of red blood cells RBCs or when the user touches Wash During the Wash phase the device pumps saline solution into the spinning bowl The saline solut...

Page 85: ...n reservoir The volume returned to the red line is subtracted from the processed volume Emergency Options In emergency situations where users are managing high blood loss it may be necessary to accele...

Page 86: ...e still processes blood continuously at high speeds through the Fill Wash and Empty phases Note To switch to Emergency Mode when in Manual Mode first select another settings group from the Active Sett...

Page 87: ...th saline is necessary to decrease viscosity within the Reservoir before initiating Quick Transfer To avoid clotting in the Reservoir ensure the volume of blood is properly anticoagulated before initi...

Page 88: ...hases are manually selected by the user In Manual Mode The line sensor and bowl optics are disabled The air detector is used for volume accounting in the Fill Wash and Concentrate phases and to determ...

Page 89: ...irm to switch to Manual Mode The device remains in the same phase it was in prior to the transition to Manual Mode for example Fill Wash and so on All processing phases are now available from the touc...

Page 90: ...nt is losing blood steadily and rapidly processing may begin as soon as a minimum of 200 mL default of 800 mL of fluid enters the reservoir However it is more typical to begin processing by initiating...

Page 91: ...ate another fill cycle Note If the amount of fluid available in the reservoir for processing is insignificant discard the remaining fluid with the disposable set bowl according to local guidelines Exi...

Page 92: ...cause the hematocrit of the bowl contents is lower there is more supernatant in the bowl In order to dilute the larger volume of supernatant a partial bowl should use two times the normal saline solut...

Page 93: ...hed packed cells are depleted of clotting factors The physician must monitor the quantity of washed cells returned to the patient and supplement the washed packed cells with fresh frozen plasma and pl...

Page 94: ...on page 79 6 Once the new processing set is installed touch Resume Procedure All procedure statistics from the procedure will be retained and suction can remain on throughout this process Changing th...

Page 95: ...e to flush any remaining blood in the line into the RBC bag During this Empty phase a Purging Blue Line message appears in the message area When the blue line has been fully purged a Procedure Complet...

Page 96: ...s When you end a procedure the Records screen appears displaying the procedure record for the current procedure Figure 45 Example of the current procedure record The right side of the screen provides...

Page 97: ...ve air from the RBC bag The pump rotates as long you are touching Pump 3 Release Pump to stop the pump 4 To return to the Records screen touch Done Resuming a Procedure To resume the procedure after t...

Page 98: ...he selected suction level for another 10 minutes This cycle repeats continuously throughout post op operation Note Intraoperative suction levels on the Cell Saver Elite device are not intended to be u...

Page 99: ...the sterile field to the reservoir Note This connection may be made after the patient and device are present in the PACU If using a different device in the PACU the patient data collected in the OR w...

Page 100: ...sed in intra op follow the steps below to prime the reservoir 1 Open the postoperative set using aseptic technique 2 Pass the contents into the sterile field 3 Attach the individual wound drain connec...

Page 101: ...essing Set 105 Installing the Blood Bag Adaptor Harness 109 Installing the Collection Bag Harness 110 Inspecting the Installation 111 Performing a Sequestration Procedure 112 Procedure Overview 112 Pr...

Page 102: ...wer source Warning Ground continuity can only be achieved when the equipment is connected to a properly grounded outlet Note The Cell Saver Elite device is classified as a continuous operation Class I...

Page 103: ...onnected to the drain tube attached to the underside of the device 3 Ensure that there are no kinks or twists in the tubing and allow the bag and its tubing to hang from the drain tube See Figure 49 4...

Page 104: ...op down list to select the Sequestration protocol The device displays the Sequestration Bowl Selection screen Note During the power on self tests POST the device checks the interlocks for the device a...

Page 105: ...protocol load the reservoir and vacuum line 1 Place the reservoir in the reservoir weigher so that the three filtered inlet ports face the tubing support Note The reservoir weigher should be no higher...

Page 106: ...nnection is secure Figure 50 RBC bag Installing the Tubing Harness To install the processing set tubing harness 1 Open the cover centrifuge header arm valve module cover and pump platen 2 Lift the rem...

Page 107: ...ent line sensor 2 Install the bowl in the centrifuge by carefully pressing down on the shoulders of the bowl until it is seated securely in the chuck Figure 52 Inserting the bowl into the centrifuge c...

Page 108: ...Avoiding Flow Restrictions on page 65 for more information Installing the Effluent Line Sensor Tubing To install the effluent line tubing 1 Floss the effluent tubing into the effluent line sensor gro...

Page 109: ...onnect the red line from the processing set to the red line connection on the adaptor set 3 Connect the reservoir drain port connection on the adaptor set to the reservoir drain port Note If a reservo...

Page 110: ...ion bag harness 1 Disconnect the effluent line tubing from the waste bag 2 Connect the effluent line tubing to the effluent line connection on the collection bag harness 3 Cap off the waste bag using...

Page 111: ...r completing the installation 1 Inspect all parts of the disposable components and verify that there are no twists kinks or flat spots 2 Verify that all connections are secure and all appropriate clam...

Page 112: ...Sequestration set is then attached to the processing set as described in this chapter Prior to running the Sequestration protocol with the Cell Saver Elite device you should be familiar with the oper...

Page 113: ...chet clamps on the collection bags are closed 4 Following the prompts on the screen a Open the white air line clamp and close the yellow PPP line and blue PRP line clamps when prompted b Agitate the b...

Page 114: ...ellow PPP line clamp 2 Touch Continue to begin collecting PPP Figure 58 Example of a Sequestration process prompt Plasma should flow into the PPP bag at a consistent flow rate until the white buffy co...

Page 115: ...et of prompts when the buffy coat starts to exit the bowl 1 Open the blue PRP line clamp and close the yellow PPP line clamp 2 Touch Continue to begin collecting PRP Figure 59 Example of a Sequestrati...

Page 116: ...wer during the Empty cycle do not touch the valve cover latch while recovering the procedure If you do open the valve cover latch ensure it is completely closed before recovering the procedure Concent...

Page 117: ...Sequestration Protocol Early You can choose to end the Sequestration procedure early Follow the steps below to end the procedure early 1 Touch Pause to pause the procedure 2 Touch End Procedure A prom...

Page 118: ...ice displays a prompt Figure 62 Changing to Cell Salvage 3 Following the instructions on the screen change to a Cell Salvage processing set a Disconnect the collection bag harness from the effluent tu...

Page 119: ...the device detects there is still fluid in the bowl it empties the bowl to the blue line The device then pumps a small amount of air through the blue line to flush any remaining blood in the line into...

Page 120: ...otentially harmful to the patient should be used when returning processed concentrated RBCs Attention Depending upon the hematocrit of the incoming whole blood a 225 mL bowl can yield 800 mL or more o...

Page 121: ...ed from a patient who might not normally have been accepted for blood donation Therefore unless the blood passes current applicable or hospital donation standards the products obtained in autotransfus...

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Page 123: ...th Settings Groups 125 Creating a New Settings Group 125 Editing a Settings Group 126 Locking a Settings Group 127 Applying a Settings Group 128 Deleting a Settings Group 128 Modifiable Settings 129 D...

Page 124: ...a settings group This enables you to quickly change settings during a procedure by touching Active Settings and selecting a different settings group from the drop down list The Cell Saver Elite device...

Page 125: ...s group Create a new settings group Edit a settings group Lock a settings group Delete a settings group Haemonetics configures each device with a default settings group called Haemonetics Default and...

Page 126: ...Group Editing a Settings Group The parameter list displays the individual settings in a settings group Follow the steps below to edit the settings in a settings group 1 Select a settings group to edit...

Page 127: ...er than the new target volume In that case the new target volume will not apply until the next cycle Note Changing the current settings group will overwrite any manual adjustments you may have made Lo...

Page 128: ...ied to the current procedure and appears on the Active Settings pad Note All changes will take place immediately except target volume settings if the current processed volume is greater than the new t...

Page 129: ...See Making the Quick Transfer and Manual Mode Settings Available on page 136 for more information Manual Mode On Off Off This parameter is displayed only if it has been enabled in Options See Making t...

Page 130: ...mL min for a 125 mL bowl during the Concentrate phase from 125 150 mL min 75 125 mL min for a 125 mL bowl and during a Wash phase after a Concentrate phase from 100 200 mL min 75 175 mL min for a 125...

Page 131: ...6050 7500 2050 2100 for the 70 mL bowl 6050 7500 for the 70 mL bowl 100 Conc Centrifuge Speed 3850 3850 5000 2050 2100 for the 70 mL bowl 5650 7500 for the 70 mL bowl 100 Table 16 Cell Salvage Manual...

Page 132: ...ng a normal full bowl Because the hematocrit of the bowl contents is lower there is more supernatant in the bowl In order to dilute the larger volume of supernatant a partial bowl may require two time...

Page 133: ...e Making the Quick Transfer and Manual Mode Settings Available on page 136 for more information On Allows Manual Mode to be displayed on the Active Settings drop down list Off Does not allow Manual Mo...

Page 134: ...bility of red cell spillage caused by pumping fluid into a bowl of red blood cells with poor or no separation Parameters Cell Salvage Fill Start Volume The approximate volume of fluid in the reservoir...

Page 135: ...at which the centrifuge turns while the bowl is filling with whole blood and during the PPP collection phase PRP Collection Pump Rate The approximate rate at which the pump turns while collecting flu...

Page 136: ...reating a New Settings Group on page 125 Note Contact your local Haemonetics representative for access to training and the password to make this feature available To make the Quick Transfer or Manual...

Page 137: ...ser Manual P N 130859 US Manual Revision AA Chapter 8 Records Overview 138 Procedure Records 140 Record Tab 140 Volume By Cycle Tab 142 Disposables Tab 143 Events Tab 144 Event Records 145 Device Reco...

Page 138: ...additional information and export data to a USB flash drive To access the Records screen 1 Touch Menu 2 Select Records from the drop down list The current procedure record appears Figure 67 Example o...

Page 139: ...en a past procedure record by selecting it from the list and touching View For more information on procedure records see Procedure Records on page 140 or you can touch Events or Device to view the eve...

Page 140: ...Record Tab The Record tab displays general information about the procedure and can include the following Cell Salvage Sequestration start time and duration Suction start time Total processed volume T...

Page 141: ...r edit procedure details 1 Select the field and touch Edit 2 Depending on the field selected a keyboard or a list of pre configured options appears Either type in the information and touch Accept to s...

Page 142: ...trate volume and for Sequestration PPP and PRP volume Figure 70 Example of the Volume By Cycle tab If concentrate is used during the procedure the volume of RBCs removed from the RBC bag during the co...

Page 143: ...mple of the Disposables tab Adding an Item to the Disposables Record To add a new item to the disposables record scan the barcode or follow the steps below to enter it manually 1 Touch New A new item...

Page 144: ...ted To exit and return to the Processing screen touch Done If you navigate to a different screen without touching Done your changes will still be saved Events Tab The Events tab displays information a...

Page 145: ...occurred on the device This information includes the date and time the event occurred the event ID number and a short description To view the full event message see Event Messages on page 166 To acces...

Page 146: ...udes the following Top level software SW version Application APP SW version SmartSuction SS software version Graphical user interface GUI SW version Date time of last SW update Device serial number Fi...

Page 147: ...t procedure records 1 Touch Menu 2 Select Records from the drop down list The current procedure record appears 3 Connect the USB flash drive to the device Export appears 4 Do one of the following To e...

Page 148: ...n AA Haemonetics Cell Saver Elite User Manual Note The downloaded data is stored in a CSV file and can be viewed using Microsoft Excel The data for each procedure can be identified by a unique device...

Page 149: ...etics Cell Saver Elite User Manual P N 130859 US Manual Revision AA Chapter 9 Help System Overview 150 The Help System 151 Accessing the Help System 151 Navigating the Help Menu 151 Performing a Searc...

Page 150: ...system features a search function and includes the following help topics Disposable Components Setup Cell Salvage Sequestration Suction Settings Records System Troubleshooting The following chapter d...

Page 151: ...s a help menu on the left side of the screen with a list of topics Use the scroll bar to view additional topics or touch Search to search for a specific keyword When you touch a topic the correspondin...

Page 152: ...The Cell Saver Elite help system includes a search feature which enables you to search the help content by keyword To perform a search 1 Touch Search A keyboard appears 2 Type a keyword s and touch A...

Page 153: ...Help System 153 Haemonetics Cell Saver Elite User Manual P N 130859 US Manual Revision AA Figure 78 Example of search results...

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Page 155: ...156 Cleaning the Device 157 Replacing the Biohazard Waste Bag 159 Cleaning the Optical Lenses 159 Cleaning the Centrifuge Well 159 Cleaning the Fluid Detector 160 Cleaning the Pump 160 Washing Replaci...

Page 156: ...ing procedures of certain key components to maintain the optimal performance of the device Haemonetics recommends cleaning the device on an as needed basis Frequency of cleaning for each individual de...

Page 157: ...leak from the bowl immediately turn the power off and unplug the device from the grounded AC electrical outlet Alert Follow universal blood precautions by wearing disposable gloves and protective eyew...

Page 158: ...ual blood around the clips 8 Use a 60 cc syringe to irrigate the centrifuge drain holes with water Direct the fluid into the gap between the chuck and the centrifuge wall See Figure 79 Figure 79 Irrig...

Page 159: ...irty or clouded lens could interfere with proper operation of the sensor An optical lens should always be cleaned after a blood spill If water alone will not clean the lenses a cleaning solution may b...

Page 160: ...er the pump rotor and pump platen with mild soap and hot water 3 Rinse the area with distilled sterile water 4 Dry the area with lint free gauze or cloth 5 Check that all moving parts can rotate or sl...

Page 161: ...disposal 5 Insert a new filter pad Ensure that the textured surface faces the device 6 Place the black plastic cover back in position and press down on it gently until it snaps into position 7 Record...

Page 162: ...ed the Haemonetics Customer Care Center should be contacted to provide specific instruction Equipment Disposal For details on how to properly dispose of any Cell Saver Elite equipment contact your loc...

Page 163: ...r Manual P N 130859 US Manual Revision AA Chapter 11 Troubleshooting Troubleshooting Scenarios 164 Vacuum Problems 164 Decreased Air Flow Aspiration Problems 164 Touch Screen Problems 165 Device Cover...

Page 164: ...ir leak 1 Ensure the vacuum line is securely connected to the device and the collection reservoir and check for leaks 2 Check that the collection reservoir has no open tubes or ports 3 Ensure the A A...

Page 165: ...While in the Ready screen press the Stop key rapidly until the Calibration screen appears 2 Follow the prompts to calibrate the touch screen and touch Accept when complete 3 Restart the device Table...

Page 166: ...fluent line sensor The procedure can be performed but the device cannot monitor the effluent from the bowl Corrective Action To perform the procedure with the user monitoring the effluent 1 Touch Cont...

Page 167: ...nnot automatically enter the Fill phase Corrective Action Touch Fill to start Fill when there is adequate fluid in the reservoir Touch OK to close this message Service is required to repair the reserv...

Page 168: ...on The air detector sensed air in the blue line during the Concentrate phase The RBC bag may be empty Corrective Action 1 Ensure the blue line clamp is open 2 Check the tubing for kinks occlusions and...

Page 169: ...sh to wash a partial bowl OR Touch Return to return RBCs to the reservoir 113 Air Detected During Fill Explanation The air detector sensed air in the red line during the Fill phase The blood bag may b...

Page 170: ...e current cycle 2 The device will empty the bowl contents to the RBC bag 115 Air Detected Early Explanation The air detector sensed air before the expected volume was pumped from the bowl Corrective A...

Page 171: ...mmended to QC the RBC product to ensure no hemolysis occurred 6 Touch Continue to continue NOTE When in Quick Transfer mode the following steps are also displayed 7 Touch New Transfer to begin a new F...

Page 172: ...with the barcode reader Scanning has been disabled Corrective Action 1 Enter information manually using the Records screen 2 Touch OK to close this message Service is required to repair the barcode re...

Page 173: ...ing the regulator vacuum level to the desired level If the A A line is not clamped the vacuum level may exceed the selected vacuum level and affect performance of the device 123 Bowl Optics Failure Ex...

Page 174: ...point approximately 1 4 inch over the shoulder of the bowl The hematocrit of the product may be reduced if the Wash phase is started before the bowl is full OR To end the procedure 1 Touch End Procedu...

Page 175: ...owl size or scan the processing set barcode 128 Fluid Detected Early Explanation The bowl optics have detected fluid in bowl earlier than expected for the 70 mL bowl NOTE This could occur if saline wa...

Page 176: ...ation in the centrifuge 2 Touch Change Bowl Size 3 Select the new bowl size or scan the processing set barcode 130 Fluid Detected Early Explanation The bowl optics have detected fluid in bowl earlier...

Page 177: ...ag load cell calibration values are out of the acceptable range Retry calibration Corrective Action See service manual for additional information 133 Manifold Pressure Load Cell Calibration Failure Ex...

Page 178: ...rred because the centrifuge and pump were stopped when there was fluid in the bowl The centrifuge is coming up to speed and will spin for 50 seconds to re establish separation in the bowl The pump wil...

Page 179: ...ctive Action Restart the device If the problem persists service is required 145 Pump Failure Explanation An issue has been detected with the pump Corrective Action Restart the device If the problem pe...

Page 180: ...sed and locked for the procedure to continue Corrective Action Close the device cover 152 Fluid Detected in Centrifuge Well Explanation The device detected fluid in the centrifuge well There may have...

Page 181: ...n issue with the wash solution Corrective Action If the effluent is clear 1 Touch Empty Bowl to empty the bowl 2 At the end of the Empty phase check the tubing for correct placement in the effluent li...

Page 182: ...d cells might have been damaged if the parts of the device that contact the processing set rose above 42 C Corrective Action 1 If the temperature of the device parts that contact the processing set ca...

Page 183: ...problem persists service is required 163 Valve Cover Not Closed Explanation The valve module cover latch is not closed Corrective Action 1 Clamp the red yellow and blue lines 2 Check the tubing manifo...

Page 184: ...ervice is required 168 Excessive Pressure in Red line Explanation The manifold pressure sensor detected high pressure in the red line during the Return phase The centrifuge must stop before the cover...

Page 185: ...as expected The centrifuge must stop before the cover will unlock and corrective action can be taken Corrective Action 1 Open the pump platen 2 Ensure tubing placement around the pump is correct 3 Ens...

Page 186: ...ecommended volume of saline solution Corrective Action Touch Continue to empty the bowl OR Touch Resume Wash to enter Wash 177 Yellow Line Valve Position Error Explanation An issue has been detected w...

Page 187: ...over 6 Unclamp the lines 7 Close the device cover 8 Touch Continue to continue If the problem persists service is required 179 Blue Line Valve Position Error Explanation An issue has been detected wit...

Page 188: ...l is empty If the bowl is not empty its contents will have to be returned to the reservoir and processed again 182 Waste Bag Full Explanation The device has detected approximately 8 5 liters of fluid...

Page 189: ...wash volume OR To end the procedure 1 Touch End Procedure 2 If in the power on self test power down the device If the problem persists service is required to resolve this issue 184 Air Detected During...

Page 190: ...ion Please service the device before continuing use 187 Manifold Pressure Sensor Calibration Failure Explanation An issue has been detected with the manifold pressure sensor calibration during the pow...

Page 191: ...ng use 191 Software Version Error SS Explanation An issue has been detected with the SmartSuction software version during power up Corrective Action Please service the device before continuing use 195...

Page 192: ...not empty 1 Ensure the red line clamp is open 2 Check the tubing for kinks occlusions and correct placement in the air detector and pump 3 Touch Continue Using Blood Bag to proceed If the blood bag i...

Page 193: ...pts to continue OR To complete the Sequestration cycle 1 Touch End Cycle to end the current cycle 2 The device will empty the bowl contents to the RBC bag If the problem persists service is required t...

Page 194: ...are has been successfully updated The device must be restarted before continuing with normal operation Corrective Action Restart the device 232 Blue Line Valve Position Error Explanation An issue has...

Page 195: ...the shoulder of the bowl The hematocrit of the product may be reduced if the Wash phase is started before the bowl is full OR Power down the device Service is required to fully resolve this issue 234...

Page 196: ...calibration data for the device suction Recalibration of the device suction is required Corrective Action 1 Connect an external regulated suction source to the reservoir 2 Touch OK to close this mess...

Page 197: ...acement in the effluent line sensor 2 Clean the effluent line sensor 3 Check the line for closed clamps kinks or occlusions 4 If using external vacuum ensure the level is not greater than 250 mmHg 5 T...

Page 198: ...clean the effluent line sensor and reinstall the tubing 3 Close the device cover 248 Duplicate Settings Group Name Explanation There cannot be two settings groups with the same name Corrective Action...

Page 199: ...o empty RBCs back to the RBC bag 2 Touch Fill to repeat Sequestration with RBCs from the blood bag 255 Recentrifuge Delay Explanation The procedure is establishing a platelet layer The pump will resta...

Page 200: ...n the USB flash drive and the software update was not completed successfully Corrective Action Service is required to resolve this issue 259 Software Update Interrupted Explanation The software update...

Page 201: ...sing a partial bowl may have a lower hematocrit than blood processed using a normal full bowl Because the hematocrit of the bowl contents is lower there is more supernatant in the bowl In order to dil...

Page 202: ...e device is trying to relieve suction All other device functions continue to operate normally Corrective Action 1 Check for kinks or obstructions in the vacuum line A A line or reservoir inlet ports 2...

Page 203: ...ly the bowl centrifuge arm pump platen manifold valve cover device cover and tubing clamps must be in the correct positions Corrective Action 1 Ensure the bowl is properly placed in the centrifuge 2 E...

Page 204: ...s entered Wash based on judgment that the volume of red blood cells in the bowl is sufficient to warrant a single wash volume Corrective Action To change the wash volume touch Cycle Wash Volume and ad...

Page 205: ...3 Turn power on OR Touch Resume Procedure to resume the procedure OR Touch Remove Air to remove air from the RBC bag OR Access settings records or help from the menu 280 Vacuum Detected in Yellow Line...

Page 206: ...nd hold Pump to remove air from the reinfusion bag 3 Release Pump to stop the pump 283 USB Flash Drive Error Explanation An error occurred while transferring data with the USB flash drive The operatio...

Page 207: ...ies the bowl to the product line and purges the blue line before marking the procedure complete End Procedure Since the fluid in the bowl is not washed the system returns the bowl contents to the red...

Page 208: ...Operator Action Required Explanation The bag line clamps must be set to continue Sequestration Corrective Action 1 Set the bag line clamps as follows CLOSE the white air line clamp CLOSE the blue PRP...

Page 209: ...ed Explanation The bag line clamps must be set to continue Sequestration Corrective Action 1 Set the bag line clamps as follows CLOSE the white air line clamp CLOSE the blue PRP line clamp OPEN the ye...

Page 210: ...lamp 2 Agitate the RBC bag 3 Touch Continue to concentrate 309 Blood Bag Is Empty Explanation Air was detected while filling the bowl Sequestration will continue using fluid from the RBC bag Correctiv...

Page 211: ...vage to continue to Cell Salvage OR 1 Touch Sequestration to return to Sequestration 312 Confirmation Required Explanation The Cell Salvage menu option was selected This will stop Sequestration Confir...

Page 212: ...settings or a custom settings group with Fat Reduction set to off If the process has already completed the wash step using the full wash volume touching Empty will empty the bowl immediately skipping...

Page 213: ...as not completed successfully Corrective Action Retry the software update If the problem persists service is required 500 Confirmation Required Explanation The software update option was selected This...

Page 214: ...on AA Haemonetics Cell Saver Elite User Manual 501 Device Restart Is Required Explanation The device must be restarted before continuing with normal operation Corrective Action Restart the device Tabl...

Page 215: ...Haemonetics Cell Saver Elite User Manual P N 130859 US Manual Revision AA Appendix A IEC EN 60601 1 2 Standard Requirements Operation Precautions 216 Electromagnetic Compatibility 217...

Page 216: ...ted to an appropriately grounded power source Mobile radio frequency RF communication equipment not approved by Haemonetics and portable communication equipment can affect the system Any accessories a...

Page 217: ...23 Guidance and Manufacturer s Declaration Electromagnetic Emissions The system is intended for use in the electromagnetic environment specified below The customer or user of the system should ensure...

Page 218: ...should be that of a typical commercial or hospital environment Surge IEC EN 61000 4 5 0 5 kV 1 kV differential mode 0 5 kV 1 kV 2 kV common mode 0 5 kV 1 kV differential mode 0 5 kV 1 kV 2 kV common...

Page 219: ...Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situa...

Page 220: ...imum output power of transmitter Watts W Separation distance according to frequency of transmitter meters m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74...

Page 221: ...50 430 470 GMRS 460 FRS 460 FMc 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5...

Page 222: ...Table 27 Test specifications for enclosure port immunity to RF wireless communications equipment The system is intended for use in the electromagnetic environment specified below The customer or user...

Page 223: ...Haemonetics Cell Saver Elite User Manual P N 130859 US Manual Revision AA Appendix B System Performance Cell Salvage 224...

Page 224: ...wl 70 mL Bowl HCT 58 4 2 52 2 4 52 1 2 RBC Recovery 94 1 8 91 2 9 90 2 9 WBC Removal 36 9 11 3 29 4 10 9 34 7 10 9 Free Hemoglobin Washout 99 0 0 2 99 6 0 1 99 3 0 1 Total Protein Washout a a Total pr...

Page 225: ...0 5 Total Protein Washout a 99 3 0 1 99 5 0 1 Potassium Washout 95 2 0 4 96 4 0 1 Heparin Washout 98 4 0 1 98 6 0 1 Table 32 Low Wash Parameter 225 mL Bowl 125 mL Bowl 70 mL Bowl Wash volume per Cycl...

Page 226: ......

Page 227: ...Haemonetics Cell Saver Elite User Manual P N 130859 US Manual Revision AA Appendix C Cart Assembly Instructions Installing the Device on the Cart 228...

Page 228: ...228 Appendix C P N 130859 US Manual Revision AA Haemonetics Cell Saver Elite User Manual Installing the Device on the Cart 1 2 3 4 5...

Page 229: ...Cart Assembly Instructions 229 Haemonetics Cell Saver Elite User Manual P N 130859 US Manual Revision AA...

Page 230: ......

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