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Haemonetics

Cell Saver

Elite

User Manual

P/N 120745-IE, Manual revision: AA

Chapter 12

Reference Information

Appendix A: IEC/EN 60601-1-2:2001 Standard Requirements . . . . . . . . . 212

Operation Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213

Appendix B: System Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

Cell Salvage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

Appendix C: Assembling the Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219

Summary of Contents for Cell Saver Elite

Page 1: ...User manual Not for use with software prior to revision AM P N 120745 IE Manual revision AA June 2016 0123...

Page 2: ...ctions on the proper use and maintenance of certain Haemonetics Corporation products This manual should be used in conjunction with instruction and training supplied by qualified Haemonetics personnel...

Page 3: ...s only the most recent version of this document to be valid Trademarks and Patents Haemonetics Cell Saver Elite and SmartSuction are trademarks or registered trademarks of Haemonetics Corporation in t...

Page 4: ......

Page 5: ...ions 19 Device Classification 19 Physical Specifications 19 Environmental Specifications 19 Electrical Specifications 20 Suction Specifications 21 Laser Specifications 21 Ordering Information 23 Chapt...

Page 6: ...posable Set Description Overview 52 Reservoir 53 The A A Line Post Op Set 54 A A Line 54 Post Op Set 54 Vacuum Line 55 Processing Set Elements 56 Tubing Harness 56 Bags 57 Centrifuge Bowl 57 Sequestra...

Page 7: ...the Device 76 Unfolding the Biohazard Waste Bag 77 Power on procedure 78 Installing the Cell Salvage Disposables 79 Inspecting the Disposable Sets 79 Collect First Setup 79 Installing the Processing S...

Page 8: ...rview 110 Processing from Blood Bags 110 Initiating a Procedure 110 Collecting PPP 111 Collecting PRP 112 Emptying the Bowl 113 Concentration During Sequestration 114 Ending the Sequestration Protocol...

Page 9: ...g the Optical Lenses 155 Cleaning the Centrifuge Well 155 Cleaning the Fluid Detector 156 Cleaning the Pump 156 Washing Replacing the Air Filters 156 Replacing the Fuses 157 Inspecting the Power Cord...

Page 10: ...10 Table of Contents P N 120745 IE Manual revision AA Haemonetics Cell Saver Elite User Manual Appendix C Assembling the Cart 219...

Page 11: ...fusion System 12 Indications for Use 12 Contraindications 13 Features of the Cell Saver Elite System 13 Blood Product Quality 14 Symbols 16 Symbols Found in This Document 16 Symbols Found on the Devic...

Page 12: ...stroma platelets activated clotting factors extracellular potassium free hemoglobin anticoagulant and cardioplegia The washed packed RBCs are then pumped to a bag for gravity reinfusion to the patient...

Page 13: ...te system may be contraindicated for example in the case of sepsis or malignancy The responsibility for the use of this device belongs solely to the physician in charge Features of the Cell Saver Elit...

Page 14: ...ycle procedures processing 10 hematocrit test pools Lysate and heparin were added to measure constituent washout Results are listed below for test pools prepared both with and without lysate Mean valu...

Page 15: ...Saver Elite User Manual P N 120745 IE Manual revision AA See Appendix B System Performance on page 217 for complete blood quality performance results for all bowl sizes and other settings including Fa...

Page 16: ...n which could result in serious personal injury to the patient or user Symbols Found on the Device The following symbols may appear on the device or device packaging Caution Consult accompanying docum...

Page 17: ...rial number Catalog list number Laser radiation Shock hazard General symbol for recovery recyclable To indicate that a material is part of a recovery recycling process Note Applicable only to those pr...

Page 18: ...0745 IE Manual revision AA Haemonetics Cell Saver Elite User Manual Storage conditions humidity level Storage conditions temperature level Storage conditions keep dry Fragile handle with care This end...

Page 19: ...pproximate dimensions and weight of the Cell Saver Elite device are as follows The noise level of the Cell Saver Elite device is 70 dB Environmental Specifications The following environmental conditio...

Page 20: ...wer source used must be properly grounded In accordance with IEC EN 60601 1 standard medical electrical equipment general requirements for safety Table 4 Environmental Specifications Conditions Values...

Page 21: ...12 ft 3 6 m Recommended A A line inner diameter 0 3 in 7 6 mm Recommended suction tip inner diameter 0 3 in 7 6 mm Operating vacuum 20 to 150 mmHg 2 7 to 20 0 kPa 26 7 to 200 mbar Vacuum cutoff 175 mm...

Page 22: ...ual revision AA Haemonetics Cell Saver Elite User Manual The following labels may appear on the device a The Cell Saver Elite device complies with IEC EN 60825 1 2007 standard safety of laser products...

Page 23: ...Suction aspiration anticoagulation line HAR A 1003 10 Cell Saver collection reservoir 3 L 150 raised filter 00205 00 4 Cell Saver aspiration anticoagulation line 00208 00 20 Aspiration anticoagulant l...

Page 24: ...for touch screen mount and reservoir weigher 102924 00 Air intake filter 103003 00 Large cart bin 107090 00 Small cart bin 107094 00 2 hook saline bag hangers 107098 00 IV pole with 4 hook top 107099...

Page 25: ...ntake 32 Air Exhaust Filter 32 Touch Screen Storage Mount 32 Vacuum Connection 32 Touch Screen Cable Entry 33 Equipotential Ground Terminal Connection 33 Reservoir Weigher Connection 33 Power Entry Mo...

Page 26: ...26 Chapter 2 Equipment Description P N 120745 IE Manual revision AA Haemonetics Cell Saver Elite User Manual Removable Bins 49...

Page 27: ...nt panel 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 Ce...

Page 28: ...formation 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...

Page 29: ...ssure Sensor The manifold pressure 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 reser...

Page 30: ...id 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 Centrifu...

Page 31: ...chuck holds 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 ce...

Page 32: ...ust Filter 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...

Page 33: ...cable that 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 i...

Page 34: ...ions are normal yellow when user intervention is needed and red when the procedure is stopped There are corresponding color coded alert bars on the status indicator page 36 and the message area page 4...

Page 35: ...ce 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 screen horizontally...

Page 36: ...r area shows the current phase of the device Examples Fill Conc Wash Empty Return Standby State The area on the bottom right of the status indicator shows the current state of the device Examples stop...

Page 37: ...device detects lower 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...

Page 38: ...te User Manual Menu Figure 9 Example of the Menu pad The menu allows you to access the configurable settings the Sequestration protocol and other options The menu options include Cell Salvage Sequestr...

Page 39: ...11 Example of a phase pad in different states Light blue background The phase pad is available You can touch the pad to override the automatic progression of the device and manually move the device in...

Page 40: ...the Wash pad during the Wash phase To change the target wash volume for the current cycle 1 Touch Cycle Wash Volume The Cycle Wash Volume box appears 2 Use the pads to increase or decrease the target...

Page 41: ...touch messages to expand them to view additional information Then touch the message bar to minimize them again Yellow and red alerts automatically appear in full screen view Pump Control Pads Figure 1...

Page 42: ...error states occur during the procedure and the procedure statistics Figure 16 Example of the procedure diagram Procedure Statistics The procedure statistics appear at the right of the procedure diag...

Page 43: ...ed to touch Fill to enter the Fill phase Auto Wash Ask User When the device detects the bowl is full it will transition to the Fill Paused state display a message indicating that the bowl is full and...

Page 44: ...Solution The air detector has sensed air while in the Wash phase This icon typically indicates the wash solution needs to be replaced Unwashed Cells This icon appears if the device enters the Empty p...

Page 45: ...s and select a different settings group from the drop down list Volume Pad Figure 20 Stages of the Volume pad The Volume pad controls the audible signal that sounds for any notices warnings or alerts...

Page 46: ...ree different levels of access basic user administrator and Haemonetics technician To unlock the System screen touch Unlock enter your password and touch Accept The device setting options include Basi...

Page 47: ...P N 120745 IE Manual revision AA 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 d...

Page 48: ...ponents IV Poles The left IV pole contains the mount for the touch screen and the right IV pole contains the reservoir weigher Both poles can be easily lowered and locked in the down position for ease...

Page 49: ...sult any residual substances trapped in the filter when an air detect occurs will not count towards the volume of the reservoir Note The reservoir weigher ships with the Cell Saver Elite device but ge...

Page 50: ......

Page 51: ...45 IE Manual revision AA Chapter 3 Disposable Set Description Overview 52 Reservoir 53 The A A Line Post Op Set 54 A A Line 54 Post Op Set 54 Vacuum Line 55 Processing Set Elements 56 Tubing Harness 5...

Page 52: ...s single use disposable sets to collect blood salvaged during a procedure Each disposable set is individually packaged in a sealed plastic tub or wrapping The following disposable sets are available R...

Page 53: ...iltered inlet ports for A A line and post op suction set connections The reservoir also has a drain port on the bottom and an internal filter It connects to the processing set via the reservoir drain...

Page 54: ...mum capacity of 3 liters The Cell Saver Elite device has been calibrated to optimize SmartSuction performance with the use of Haemonetics proprietary disposables and recommended suction tips Suction a...

Page 55: ...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 56: ...connects to the unprocessed blood source The yellow line connects to the saline solution The blue line attaches to the RBC bag The tubing manifold holds the tubing in place in the pump module and hol...

Page 57: ...t air is retained in the system to empty the bowl Note When replacing the waste bag make sure the bowl is empty If the bowl is not empty return its contents to the reservoir replace the waste bag and...

Page 58: ...f the three bowl sizes Centrifuge Chuck Adaptor Warning Do not grease any part of the centrifuge or centrifuge chuck adaptor If grease has been applied to the chuck contact the Haemonetics hotline imm...

Page 59: ...gs 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 colle...

Page 60: ......

Page 61: ...65 Power Outlet Connection 65 Laser Radiation Hazards 65 Mechanical Hazards Rotating Parts 65 Communicable Disease Precautions 66 Preventing Problems During a Procedure 67 Understanding the Risk of H...

Page 62: ...first in first out FIFO technique All disposable material should be stored in a dry well ventilated area free from exposure to chemical vapors Many plastic materials are sensitive to chemicals such a...

Page 63: ...ir weigher is no higher than 129 cm 51 in from the floor Transporting a Device with Disposable Set Loaded Before moving the device with the disposable set and solutions installed lower the IV poles an...

Page 64: ...the device carefully 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 th...

Page 65: ...tions Each device receives a careful inspection for leakage current prior to leaving the factory Power Outlet Connection A power cord is supplied with the device Do not replace the power cord with a s...

Page 66: ...sure personal safety as well as the safety of others who may come in contact with the material Proper Handling of Blood Contaminated Material If a leak or blood spill should occur it should be cleaned...

Page 67: ...after 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 operati...

Page 68: ...an abnormality or noise related to the spinning bowl appears Warning If during a procedure it is discovered that any portion of the equipment within proximity of the blood has been significantly overh...

Page 69: ...m and the user restarts the Fill phase or enters the Concentrate phase If the pump has paused and the RBC layer is close1 to the bowl optics beam and the user restarts the Fill phase or enters the Con...

Page 70: ...ecoming fully packed and spilling RBCs into the waste bag Note Because the device will enter the Wash phase before the optics senses the RBC layer the hematocrit of the final RBC product may be lower...

Page 71: ...nt into the reinfusion bag Therefore the contents of the reinfusion bag should NOT be transfused under pressure Removing Air from the Reinfusion Bag If it becomes necessary to remove air from the rein...

Page 72: ...lutions are added to salvaged blood to keep it from clotting Different anticoagulants affect the clotting process in different ways The most common anticoagulant solution is 30 000 units of heparin in...

Page 73: ...this 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...

Page 74: ......

Page 75: ...Setting up the Saline Solution 85 Inspecting the Installation 85 Performing the Intraoperative Cell Salvage Procedure 86 Initiating a Procedure 86 Procedure Overview 86 Additional Functions 87 Process...

Page 76: ...opriately grounded power source Caution Grounding reliability can only be achieved when the equipment is connected to a properly grounded outlet Note The Cell Saver Elite device is classified as a con...

Page 77: ...connected 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...

Page 78: ...sts and advances 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 avo...

Page 79: ...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 than 18...

Page 80: ...delivery is a ratio between 1 5 and 1 10 anticoagulant to blood The rate for both anticoagulants should be set to give approximately 15 mL of anticoagulant for each 100 mL of blood collected This equ...

Page 81: ...ction Screen scan a processing set using the barcode reader underneath the touch screen display or select the appropriate bowl size on the touch screen The Processing screen appears 2 Extend the tub h...

Page 82: ...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 valve module cover Figu...

Page 83: ...rm Note A click will be heard when the locking mechanism is completely secured Warning Verify that the outlet port and effluent tubing are free of any restrictions prior to initiating a procedure If t...

Page 84: ...o the effluent line 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...

Page 85: ...lution bags and unclamp the lines Figure 42 Spiking the saline bags Note Each wash cycle requires a volume of saline solution that depends on the size of the bowl in use 225 mL bowl 1000 mL saline sol...

Page 86: ...uches Wash During the Wash phase the device pumps saline solution into the spinning bowl The saline solution moves through the heavy red cell layer carrying cellular components and other waste solutio...

Page 87: ...Return phase the device pumps fluid from the bowl through the red line and back to the collection reservoir or extracorporeal circuit Volume accounting is defined by the Volume Accounting parameter in...

Page 88: ...he device either automatically doubles the wash volume uses the default wash volume or provides an option to double the wash volume as determined by the Partial Bowl Wash setting See Modifiable Settin...

Page 89: ...ards a transfusion filter designed to retain particles potentially harmful to the patient should be used when returning processed concentrated RBCs Using a Transfer Pack Reinfusion of the processed bl...

Page 90: ...ocessing set from the device 5 Install a new processing set following the instructions beginning on page 81 6 Once the new processing set is installed touch Resume Procedure All procedure statistics f...

Page 91: ...blue line 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 Procedur...

Page 92: ...Functions When you end a procedure the Record screen appears displaying the procedure record for the current procedure Figure 44 Example of the current procedure record The right side of the screen p...

Page 93: ...remove air from the RBC bag The pump rotates as long as 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...

Page 94: ...her 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 used for postoperative wound draina...

Page 95: ...g a different device in the PACU the patient data collected in the OR will not be transferred to the second device 7 Close the roller clamp to the anticoagulant bag on the A A line and turn off suctio...

Page 96: ...hen ready to transport the device to the post anesthesia care unit PACU Without an Anticoagulated Post Op Line 1 Clamp the vacuum line between the hydrophobic filter and the device and disconnect it f...

Page 97: ...er it on 5 Touch Continue Procedure 6 Touch Suction on the touch screen and select Post Op from the drop down list or connect the reservoir to wall suction regulated to appropriate post op suction lev...

Page 98: ...r on the device if it is not already on 10 Touch Suction on the touch screen and select Post Op from the drop down list or connect the reservoir to wall suction regulated to appropriate post op suctio...

Page 99: ...Processing Set 103 Installing the Blood Bag Adaptor Harness 107 Installing the Collection Bag Harness 108 Inspecting the Installation 109 Performing a Sequestration Procedure 110 Procedure Overview 11...

Page 100: ...ropriately grounded power source Caution Grounding reliability can only be achieved when the equipment is connected to a properly grounded outlet Note The Cell Saver Elite device is classified as a co...

Page 101: ...connected 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 48...

Page 102: ...tion from the drop 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...

Page 103: ...The reservoir weigher should be no higher than 183 cm 72 in from the floor 2 Close the slide clamp on the reservoir drain port Do not load the A A line at this time Leave the port capped until ready t...

Page 104: ...he processing set tubing harness 1 Open the cover centrifuge header arm valve module cover and pump platen 2 Lift the remaining disposable set components from the tub and drape them over the device wi...

Page 105: ...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 51 Inserting the bowl into the centrifuge chuck 3 Position...

Page 106: ...e compromised See Avoiding Flow Restrictions on page 67 for more information Installing the Effluent Line Sensor Tubing To install the effluent line tubing 1 Floss the effluent tubing into the effluen...

Page 107: ...t 2 Connect 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 re...

Page 108: ...tall the collection 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...

Page 109: ...after completing the installation 1 Inspect all parts of the disposable set and verify that there are no twists kinks or flat spots 2 Verify that all connections are secure and all appropriate clamps...

Page 110: ...h a standard processing set A 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 sho...

Page 111: ...other parameters 3 Check that the red ratchet 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...

Page 112: ...estration process prompt Plasma should flow into the PPP bag at a consistent flow rate until the white buffy coat band made up of platelets and white cells which is immediately adjacent to the top of...

Page 113: ...ss prompt The buffy coat should flow into the PRP bag until the effluent line flow from the bowl turns medium red indicating the presence of RBCs Emptying the Bowl The device displays another set of p...

Page 114: ...rocedure Concentration During Sequestration If during the Fill phase the blood bag is empty and there are RBCs from a previous cycle in the RBC bag an event message displays the following three option...

Page 115: ...nd Procedure to end or Resume Procedure to resume Figure 60 Ending Sequestration early Changing to a Cell Salvage Procedure You can also choose to end the Sequestration procedure early and change to a...

Page 116: ...n bag line to prevent drips c Connect the effluent tubing to the waste bag d Close the blood bag line clamps e Remove the upper portion of the blood bag harness using the twist lock connector and cap...

Page 117: ...e 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 Complete message appears Note Haemonetics does not recomm...

Page 118: ...he incoming whole blood a 225 mL bowl can yield 800 mL or more of plasma and cause hypovolemia if fluid balance is not carefully maintained Many variables influence the amount of plasma that can be se...

Page 119: ...t 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 autotransfusion or plasma se...

Page 120: ......

Page 121: ...Settings Overview 122 Working with Settings Groups 123 Creating a New Settings Group 123 Editing a Settings Group 124 Locking a Settings Group 125 Applying a Settings Group 125 Deleting a Settings Gro...

Page 122: ...them as 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 Eli...

Page 123: ...to the current procedure Delete a settings group Haemonetics configures each device with a default settings group called Haemonetics Default and a specialized settings group called Fat Reduction These...

Page 124: ...p 1 Select a settings group to edit 2 Touch View The parameter list appears 3 Touch a tab to select a bowl size 4 From the list select a setting to modify 5 Touch Up or Down to change the value for th...

Page 125: ...ard appears 4 Enter the password and touch Accept Applying a Settings Group You do not need to be in the Settings screen to change the current settings group Follow the steps below to apply a settings...

Page 126: ...stination Blue Red Blue Volume Accountingb Reservoir Circuit Reservoir Final Cycle On Off Off Smart Empty On Off On Parameter 225 mL Bowl 125 mL Bowl 70 mL Bowl Min Max Step Fill Start Volume mL 800 8...

Page 127: ...end Volume mL 10 10 N A 0 50 1 PRP Milk Volume mL 3 3 N A 1 50 1 PRP Milk Delay seconds 10 10 N A 1 30 1 a Pump regulation is not applicable for the 70 mL bowl b The volume accounting parameter is onl...

Page 128: ...he Wash phase and prompts you to enter Wash continue filling or return cells to the reservoir Note This message only occurs once If you continue to fill the bowl by touching Fill or Conc the message w...

Page 129: ...to the RBC Bag the status indicator displays Empty If you touch Return the RBCs are emptied through the red line and the processed volume decreases as blood is returned to the reservoir Red If the dev...

Page 130: ...rate at which the pump turns while filling the bowl with fluid Minimum Wash Volume The minimum volume of wash solution to be used to wash one bowl of fluid Wash Pump Rate The approximate rate at whic...

Page 131: ...ermines if the process of starting and stopping the PRP collection phase is desired as determined by the programmed parameters Milk Vol and Milk Delay PRP Milk Volume The volume to pump during the PRP...

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Page 133: ...ser Manual P N 120745 IE Manual revision AA Chapter 8 Records Overview 134 Procedure Records 136 Record Tab 136 Volume By Cycle Tab 137 Disposables Tab 138 Events Tab 140 Event Records 141 Device Reco...

Page 134: ...nter 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 66 Examp...

Page 135: ...an open a past procedure record by selecting it from the list and touching View For more information on procedure records see Procedure Records on page 136 or you can touch Events or Device to view th...

Page 136: ...Done 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 volu...

Page 137: ...keyboard or a list of pre configured options appears Either type in the information and touch Accept to save or select an option from the list Note If any IDs have barcodes you can scan them using the...

Page 138: ...gure 69 The total reinfusion volume for the procedure is equal to the sum of the reinfusion volume of each individual cycle minus the sum of the Conc volume for each cycle Disposables Tab The Disposab...

Page 139: ...w the directions in Editing an Item in the Disposables Record Editing an Item in the Disposables Record To edit an item in the disposables record 1 Select the field of the item you want to edit 2 Touc...

Page 140: ...avigate to a different screen without touching Done your changes will still be saved Events Tab The Events tab displays information about any event messages that may have occurred during the selected...

Page 141: ...have 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 162 To...

Page 142: ...includes 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 numbe...

Page 143: ...export 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...

Page 144: ...ision 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 dev...

Page 145: ...etics Cell Saver Elite User Manual P N 120745 IE Manual revision AA Chapter 9 Help System Overview 146 The Help System 147 Accessing the Help System 147 Navigating the Help Menu 147 Performing a Searc...

Page 146: ...ls The help system features a search function and includes the following help topics Disposable Setup Cell Salvage Sequestration Suction Settings Records System Troubleshooting The following chapter d...

Page 147: ...atures 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 corresp...

Page 148: ...Search The Cell Saver Elite help system includes a search feature which allows you to search the help content by keyword To perform a search 1 Touch Search A keyboard appears 2 Type a keyword s and to...

Page 149: ...Chapter 9 Help System 149 Haemonetics Cell Saver Elite User Manual P N 120745 IE Manual revision AA Figure 77 Example of search results...

Page 150: ......

Page 151: ...g Supplies 152 Cleaning the Device 153 Replacing the Biohazard Waste Bag 155 Cleaning the Optical Lenses 155 Cleaning the Centrifuge Well 155 Cleaning the Fluid Detector 156 Cleaning the Pump 156 Wash...

Page 152: ...the device Haemonetics recommends cleaning the device on an as needed basis Frequency of cleaning for each individual device depends on the number of procedures performed The user should inspect the d...

Page 153: ...ood spill or leak from the bowl immediately turn the power off and unplug the device from the grounded AC electrical outlet Warning Follow universal blood precautions by wearing gloves and protective...

Page 154: ...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 78 Figure 78 Irrigating the centrifuge drain holes 9 All...

Page 155: ...er alone will not clean the lenses a cleaning solution may be used but any application of cleaning solution should be followed by a wipe down with distilled sterile water applied with lint free gauze...

Page 156: ...or cloth 5 Check that all moving parts can rotate or slide freely 6 Ensure that the pump rotor and pump platen are completely dry before reassembling the pump 7 Place the pump rotor and cover back in...

Page 157: ...ure 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 the date of maintenance Replacing the...

Page 158: ...eyond the routine maintenance and cleaning described in this manual is required the local Haemonetics representative should be contacted to provide specific instruction Product Return Guidelines Warni...

Page 159: ...r Manual P N 120745 IE Manual revision AA Chapter 11 Troubleshooting Troubleshooting Scenarios 160 Vacuum Problems 160 Decreased Air Flow Aspiration Problems 160 Touch Screen Problems 161 Device Cover...

Page 160: ...oblems Air 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...

Page 161: ...hed 1 Restart the device 2 Upon restarting the device you are presented with the option to continue with the previous procedure or to start a new procedure Select the desired option Table 15 Troublesh...

Page 162: ...ed but the device cannot monitor the effluent from the bowl Corrective Action To perform the procedure with the user monitoring the effluent 1 Touch Continue 2 Monitor the effluent from the bowl durin...

Page 163: ...ice cannot 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...

Page 164: ...xplanation 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 occlus...

Page 165: ...ch Wash 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...

Page 166: ...1 Replace the blood bag 2 Touch Continue Using Blood Bag to proceed To end the cycle 1 Touch End Cycle to end the current cycle 2 The device will empty the bowl contents to the RBC bag 115 Air Detect...

Page 167: ...the effluent tubing for correct placement in the effluent line sensor 4 Check the effluent tubing for kinks and occlusions 5 Check the blue and red tubing for kinks and occlusions NOTE If a kink or oc...

Page 168: ...optics have not detected fluid in the bowl when expected Corrective Action 1 Ensure the red line clamp is open 2 Check the tubing for kinks and occlusions 3 If using external vacuum ensure the level i...

Page 169: ...y 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 124 Bowl Optics Failure Explanation An issue has been detecte...

Page 170: ...Bowl Size OR If a Latham bowl is installed 1 Touch Change Bowl Size 2 Select the new bowl size or scan the processing set barcode 127 Bowl Size Mismatch Explanation A 70 mL bowl was detected but a Lat...

Page 171: ...is installed 1 Touch Change Bowl Size 2 Select the new bowl size or scan the processing set barcode 129 Fluid Detected Early Explanation The bowl optics have detected fluid in bowl earlier than expect...

Page 172: ...owl Size OR If a 70 mL or 125 mL bowl is installed 1 Check the bowl and chuck adaptor 70 mL bowl for proper installation in the centrifuge 2 Touch Change Bowl Size 3 Select the new bowl size or scan t...

Page 173: ...ystem Fault Explanation An issue has been detected with the system Corrective Action Restart the device If the problem persists service is required 137 Centrifuge Failure Explanation An issue has been...

Page 174: ...142 System Fault Explanation An issue has been detected in one of the internal device components Corrective Action Restart the device If the problem persists service is required 143 Device Cover Open...

Page 175: ...ellow line are open and saline is connected 3 Check the tubing placement in the air detector and pump 4 Touch Continue to continue 150 Device Cover Lock Failure Explanation The device cover will not l...

Page 176: ...ions ensure clamps are open 2 Inspect the bowl and fluid sensor 3 If a spill is observed power down the device to clean the centrifuge per instructions in the manual and replace the disposable 4 If no...

Page 177: ...placement in the effluent line sensor 3 Clean the effluent line sensor with a soft damp lint free gauze moistened with water only If the effluent is not clear 1 Ensure the correct saline solution is c...

Page 178: ...ssing set rose above 42 C Corrective Action 1 If the temperature of the device parts that contact the processing set cannot be verified to be below 42 C it is recommended to either QC the product prio...

Page 179: ...the 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 m...

Page 180: ...rsists service 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 th...

Page 181: ...ating 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...

Page 182: ...an the recommended 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 de...

Page 183: ...dule cover 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 detect...

Page 184: ...the bowl 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 o...

Page 185: ...the bowl Corrective Action To perform the procedure with the user monitoring the effluent 1 Touch Continue 2 Monitor the effluent from the bowl during processing If at the end of a wash phase addition...

Page 186: ...bowl OR Touch Conc to continue filling the bowl with red cells from the RBC bag OR Touch Wash to wash a partial bowl OR Touch Return to return cells to the reservoir 185 Reservoir Load Cell Calibratio...

Page 187: ...before the cover will unlock and corrective action can be taken Corrective Action 1 Ensure that the bowl is seated properly 2 Close and latch the centrifuge arm 3 Close the device cover If the proble...

Page 188: ...ir detector sensed air in the red line during the Fill phase The blood bag may be empty Corrective Action If the blood bag is not empty 1 Ensure the red line clamp is open 2 Check the tubing for kinks...

Page 189: ...prompts 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 requi...

Page 190: ...he software 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 is...

Page 191: ...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 Power down the device Service is required to fully resolve this issu...

Page 192: ...with the 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 t...

Page 193: ...ct placement 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 mmH...

Page 194: ...lose the device cover If this message continues to appear remove the tubing again clean the effluent line sensor reinstall the tubing and close the cover 248 Duplicate Settings Group Name Explanation...

Page 195: ...Bowl to 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...

Page 196: ...files on 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 softwar...

Page 197: ...d 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 dilute the larger volume of supernatant a partial bowl may r...

Page 198: ...when the 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...

Page 199: ...ctively 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 centrifug...

Page 200: ...user has 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 Volum...

Page 201: ...off 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...

Page 202: ...Touch and 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...

Page 203: ...empties 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...

Page 204: ...owl 303 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 b...

Page 205: ...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 line clamp OPEN...

Page 206: ...P line clamp 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 C...

Page 207: ...ll Salvage 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...

Page 208: ...Default 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...

Page 209: ...date was 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 selecte...

Page 210: ...l revision 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 dev...

Page 211: ...n AA Chapter 12 Reference Information Appendix A IEC EN 60601 1 2 2001 Standard Requirements 212 Operation Precautions 212 Essential Performance 212 Electromagnetic Compatibility 213 Appendix B System...

Page 212: ...ved by Haemonetics and portable communication equipment can affect the system Any accessories and cables not approved by Haemonetics used in conjunction with the device may increase hazards and influe...

Page 213: ...mpliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The Cell Saver Elite system uses RF energy only for its internal functions Therefore its RF emissions are very low and are n...

Page 214: ...nment Surge IEC EN 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage...

Page 215: ...ent 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 situations Electromagnetic propagation is affected by...

Page 216: ...r of the communications equipment Rated maximum output power of transmitter 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...

Page 217: ...ending on in use variables Table 21 Haemonetics Default Parameter 225 mL Bowl 125 mL Bowl 70 mL Bowl HCT 56 0 3 50 0 4 51 0 2 RBC Recovery 95 0 1 91 0 8 90 0 9 WBC Removal 39 6 9 92 35 6 5 94 22 3 2 5...

Page 218: ...0 1 Free Hemoglobin Washout 98 1 0 05 98 4 0 03 Albumin Washout 96 7 0 17 97 2 0 06 Potassium Washout 95 7 0 16 96 0 0 18 Heparin Washout 99 2 0 14 99 2 0 30 Table 24 Partial Bowl Double Wash Paramete...

Page 219: ...Chapter 12 Reference Information 219 Haemonetics Cell Saver Elite User Manual P N 120745 IE Manual revision AA Appendix C Assembling the Cart...

Page 220: ...220 Chapter 12 Reference Information P N 120745 IE Manual revision AA Haemonetics Cell Saver Elite User Manual...

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