Page 1 User Manual Not for use with software prior to revision AQ 130859-US(AA) October 2022...
Page 2 Use of any portion(s) of this document to copy, translate, disassemble or Proprietary decompile, or create or attempt to create by reverse engineering (or otherwise) the source code from the object code of Haemonetics products is expressly Notices prohibited. Disclaimer...
Page 3 Corporation. Haemonetics Corporation assumes no responsibility or liability for any errors or inaccuracies that may appear in the informational content contained in this material. For the purpose of clarity, Haemonetics Corporation considers only the most recent version of this document to be valid.
Page 5: Table Of Contents
Chapter 1, Introduction The Haemonetics Cell Saver Elite+ Device ......12 What is the Purpose of This Manual? ......12 What is the Cell Saver Elite+ Autotransfusion System? .
Page 6 Laser Radiation Hazards ........63 ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 7 Transporting the Patient ........99 Installing the Postoperative Set for Post-Op Only Use ... . .100 ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 8 Record Tab ..........140 ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 9 Electromagnetic Compatibility ........217 ® ® ® Haemonetics Cell Saver Elite + User Manual...
Page 10 Installing the Device on the Cart....... . .228 ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 11 Introduction The Haemonetics Cell Saver Elite+ Device ......12 What is the Purpose of This Manual? ......12 What is the Cell Saver Elite+ Autotransfusion System? .
Page 12: The Haemonetics Cell Saver Elite+ Device
Chapter 1 The Haemonetics Cell Saver Elite+ Device What is the ® ® The Cell Saver + User Manual provides users with the information Elite Purpose of This needed to safely operate and maintain the Cell Saver Elite+ device and ensure optimal performance.
Page 13: Essential Performance
A touch-screen display that provides both a simple interface during  operation and allows users to easily access advanced configuration options. A fat reduction protocol  ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 14: Performance Characteristics
Maximum free air flow 40 L/min Post-Op Operating vacuum 25 to100 (3.3 to 13.3 kPa; 33.3 to 133.3 mbar) Maximum free air flow 40 L/min ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 15 Table 5, Sequestration Protocol Characteristic Value Centrifuge Speed (Fill) 5650 RPM ±300 RPM Centrifuge Speed (PRP) 2450 RPM ±300 RPM Pump Speed 10 mL to 250 mL ±10% ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 16: Blood Product Quality
Heparin and Albumin Washout > 95% Laboratory testing of the 225 mL bowl using Haemonetics Default settings yielded the blood product quality results listed in the table below. Test results are based on two-cycle procedures processing 10% hematocrit test pools.
Page 17: Symbols
Document Note: provides useful information regarding a procedure or operating technique when using Haemonetics material. Attention: advises the user against initiating an action or creating a situation which could result in damage to equipment or impair the quality of the blood products;...
Page 18 Rx only (applies to USA only) Federal (USA) Law restricts the device to sale to or on the order of a physician. Serial number Catalog (list) number Warning; laser beam ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 19 Storage conditions, keep dry Fragile, handle with care This end up Refer to instruction manual/booklet MR Unsafe Warning: Keep away from magnetic resonance imaging (MRI) equipment. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 20: Device Specifications
Chapter 1 Device Specifications Note: The use of materials not provided or recommended by Haemonetics is the sole responsibility of the end-user, and the end-user will be responsible for any personal injury and/or property damage related to such use. Device...
Page 21: Electrical Specifications
Normal 100 µΑ Single Fault Reverse Open 500 µΑ Normal Open 500 µΑ *In accordance with IEC/EN 60601-1standard, medical electrical equipment, general requirements for safety. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 22: Laser Specifications
The Cell Saver Elite+ device complies with 21CFR1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007. The following labels may appear on the device: ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 23: Ordering Information
Cell Saver collection reservoir, 3L, 20 μ filter 00220-00 Cell Saver RBC bag, 1000 mL 00245-00 Note: Items listed may not be available in all markets. Please contact your local Haemonetics Authorized Sales Representative to discuss options and availability. ® ® ®...
Page 24 2-hook saline bag hangers 107098-00 IV pole with 4-hook top 107099-00 70 mL centrifuge chuck adaptor 107581-00 Power cord, US 109308-00 User manual, US 130859-US ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 25 Removable Bins ......... . .48 ® ® ® Haemonetics Cell Saver Elite + User Manual...
Page 26: Overview
9. Centrifuge system 10. Valve module 11. Cart Figure 1, Cell Saver Elite+ system components Refer to Chapter 3 for descriptions of the disposable components. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 27: Top Deck And Front Panel Components
There are two handles located on the front panel and the rear of the device. The handles enable easy lifting of the device when it is not attached to the cart. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 28: Valve Module
The cover stays locked for the duration of the procedure and unlocks automatically when the procedure is complete or if an event message requires the user to access the valve manifold. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 29: Centrifuge System
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. ® ® ®...
Page 30 Header Arm The centrifuge header arm closes around the stationary part of the bowl during a procedure. A latch secures the header arm in place. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 31: Rear And Side Panel Components
Storage Mount and transport of the device. Vacuum The vacuum connection allows the user to connect the filtered vacuum line that Connection leads to the reservoir. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 32: Touch Screen Cable Entry
A power cord is supplied with the device. Inspect for a frayed or twisted power cord. Do not replace the power cord with a substitute. If necessary, contact the Haemonetics Customer Care Center for a replacement. Always ensure the power cord is connected to an appropriately grounded power source.
Page 33: Touch Screen Display
IDs, and stores it in the memory of the device. It is located on the bottom of the device display and is active when the Bowl Selection screen and Record or Disposables tabs are displayed. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 34: Stop Key
Ethernet The Ethernet connection enables the device to communicate with the Connection designated server application (if equipped) in the absence of a wireless network connection. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 35: Graphical User Interface
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: stopped, paused. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 36 The Cell Saver Elite+ device has been calibrated to optimize SmartSuction performance with the use of Haemonetics proprietary disposable sets and recommended suction tips. Suction and fluid removal performance may decline if incorrect or non-Haemonetics disposable components are used with the system.
Page 37 Figure 10, Example of the phase pads The phase pads include the Fill, Wash, Empty, Conc, and Return pads. Phase pads change color based on their status: ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 38 Note: The Cycle Wash Volume target cannot be set below the current Wash volume. 3. Touch (Accept) to save the change or (Cancel) to exit. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 39 You can 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. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 40 It shows the movement of the pump, the movement of fluid through the disposable components, if any error states occur during the procedure, and the procedure statistics. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 41 The device cover lock indicator appears at the lower right of the procedure diagram, and indicates if the Cell Saver Elite+ device cover is locked unlocked ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 42 Fill, after which the device automatically completes the procedure according to the selected Final Cycle settings (see “Cell Salvage Default Settings” on page 129 for more information). ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 43 The Active Settings pad displays the current settings group selection. To change the active settings group, touch Active Settings and select a different settings group from the drop-down list. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 44 Volume pad. During normal operation when no alert is occurring, you can use the Volume pad to adjust the event volume or touch Mute All to mute the signal for all events. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 45: Device Settings
Figure 21, Example of the System screen The device settings 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).
Page 46  Network Settings For information on network settings, see the Cell Saver Elite+ Connectivity Upgrade User Manual Addendum. Haemonetics Technician Access Note: Haemonetics Technician Access also provides Basic User Access and Administrator Access. Service: Access the manufacturing screens.  ®...
Page 47: Cart Components
Wheels The wheels can be locked to secure the cart in position. The right rear wheel provides antistatic protection. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 48: Reservoir Weigher
Always hold onto the cart handle while tilting the cart to maintain stability. Removable The removable storage bins provide convenient storage space for any items Bins related to the device or procedure. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 49: Haemonetics ® Cell Saver ® Elite ® + User Manual
Sequestration Set ..........57 ® ® ® Haemonetics Cell Saver Elite + User Manual...
Page 50: Overview
 Aspiration and anticoagulant (A&A) line  Vacuum line  Processing set  Post-op set  Sequestration set  This chapter describes typical disposable components. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 51: Reservoir
1. Filtered inlet ports (x3) 2. Reservoir 3. Reservoir drain port 4. Vacuum line connection Figure 23, Example of a reservoir ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 52: The A&A Line And Post-Op Set
The Cell Saver Elite+ device has been calibrated to optimize SmartSuction performance with the use of Haemonetics proprietary disposable sets and recommended suction tips. Suction and fluid removal performance may decline if incorrect or non-Haemonetics disposable components are used with the system.
Page 53: Vacuum Line
Disposable Components Description Vacuum Line Attention: Use of an incorrect or non-Haemonetics vacuum line may affect suction 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 hydrophobic filter that provides overflow protection to the device.
Page 54: Processing Set Elements
The effluent line, connected to the outlet port of the bowl, exits the centrifuge well through the effluent line sensor and connects to the waste bag. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 55: Bags
Fully seating the bowl in the centrifuge chuck will ensure proper function. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 56 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 70mL bowl requires a centrifuge chuck adaptor to correctly load the bowl. The chuck adaptor is a white plastic cylinder that snaps into the centrifuge chuck.
Page 57: Sequestration Set
7. Yellow, blue, and clear line ratchet clamps 8. Air bag 9. Collection bag ratchet clamps 10. Collection bags Figure 30, Example of a Sequestration set ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 59 Sequestration ..........71 ® ® ® Haemonetics Cell Saver Elite + User Manual...
Page 60: Storing And Handling The Device And Disposable Components
Components twisted or flattened sections. Any product complaints or concerns should be reported to Haemonetics in a timely manner. Note: Adhere to the expiration date printed on the product labeling. After installing the disposable components, the user should verify the correct placement of the individual elements, prior to initiating a collection procedure.
Page 61: Transporting The Device
IV pole hooks. The reservoir weigher should be no higher than 51 in (129 cm) from the floor during transport. 51 in (129 cm) Figure 31, Example of the IV poles in the transport position ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 62 7. Remove the touch screen from the touch screen storage mount and place it on the touch screen mount. 8. Attach the reservoir weigher connection to the rear panel of the device. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 63: Warnings For The User
A power cord is supplied with the device. Do not replace the power cord with a Connection substitute. If necessary, contact the Haemonetics Customer Care Center for a replacement. Always ensure the power cord is connected to an appropriately grounded power source.
Page 64: Communicable Disease Precautions
If any blood-contaminated components must be returned to Haemonetics for further inspection, see “Product Return Guidelines” on page 162.
Page 65: Preventing Problems During A Procedure
If the bowl is empty, this could indicate a problem with the air detector and  the user should contact the Haemonetics Customer Care Center. Avoiding Flow Restrictions Alert: The user must avoid blocking any tubing carrying blood from the pump.
Page 66: Avoiding Overheating
Cell Saver Elite+ can cause an effect on the ECG which looks like ventricular tachycardia. To eliminate the potential for this to occur, it is recommended that the user aspirate with intermittent breaks in suction. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 67: Avoiding Red Blood Cell Spillage
2.) Excessive flow rate of saline solution due to processing parameters set by the user. Note: Haemonetics 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 spill.
Page 68: Managing The Inventory Of Air
• 70 mL bowl: 35 mL (bowl optics), 35 mL (line sensor) Within: • 6 mm (125 mL or 225 mL bowl) • 3 mm (70 mL bowl) ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 69: Patient Care Precautions
See “General Precautions When Reinfusing Processed Blood” on page 93 for more information. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 70: Replacing Depleted Clotting Factors
For hypercoagulable patients, the user may find it necessary to increase the anticoagulant dosage to prevent clotting. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 71: Factors Affecting Processing Time
3-7 times that of the incoming whole blood. Actual time and results may vary depending on bowl size, protocol settings, hematocrit of incoming blood, and platelet pre-count of the incoming blood. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 73 Transporting the Patient ........99 Installing the Postoperative Set for Post-Op Only Use ... . .100 ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 74: Preparing The Cell Saver Elite+ Device
A power cord is supplied with the device. Do not replace the power cord with a substitute. If necessary, contact the Haemonetics Customer Care Center for a replacement. Always ensure the power cord is connected to an appropriately grounded power source.
Page 75: Unfolding The Biohazard Waste Bag
AC power. Remove and replace the bag only if it is found to be contaminated with blood or fluid. See “Replacing the Biohazard Waste Bag” on page 159. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 76: Power-On Procedure
“Device Settings” on page 45 more information). To select a different settings group, touch (Menu), select Settings from the drop-down menu, and choose the desired settings group. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 77: Installing The Cell Salvage Components
7. Connect the A&A line to the reservoir and insert the A&A line into the tubing support. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 78 12. Aseptically insert the spiked end of the drip chamber into the AC solution bag. 13. Squeeze the drip chamber. 14. Reopen the roller clamp on the AC drip line to allow full flow of AC solution. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 79: Installing The Processing Set
3. Ensure that the two large ratchet clamps on the blue line are open and the twist-lock connection is secure. 1. RBC bag 2. Large ratchet clamp 3. Small ratchet clamps Figure 36, RBC bag ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 80 3. Install the bowl in the centrifuge by carefully pressing down on the shoulders of the bowl until it is seated securely in the chuck. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 81 To install the effluent line tubing: 1. Floss the effluent tubing into the effluent line sensor groove. 2. Ensure that the tubing is completely installed in the effluent line sensor. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 82: Connecting The Reservoir
2. Reservoir drain port slide clamp 3. Red line connection 4. Red line ratchet clamp Figure 41, Red line connected to the reservoir drain port ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 83: Setting Up The Saline Solution
2. Verify that all connections are secure and all appropriate clamps are closed. 3. Close the device cover, ensuring that no tubing is inadvertently clamped off. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 84: Performing The Intraoperative Cell Salvage Procedure
If the user then manually adjusts the pump speed back to the default value specified in the current settings group, pump regulation is enabled again. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 85: Cell Salvage Additional Functions
The device automatically cycles through the Fill and Empty phases continuously with a non-spinning bowl until the reservoir is empty, completely bypassing the wash phase. This feature must be ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 86 The user is responsible for executing Quick Transfer Mode and determining if the product contained in the reinfusion bag is suitable for reinfusion into the patient. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 87 When the bowl is empty, if necessary the device first purges the red line, then the blue line, and then returns to the previously selected Active Settings. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 88 Alert: When the device is in Manual Mode, if the washing of the packed red blood cells is inadequate, it may lead to an excessive level of contaminants (for example, plasma free hemoglobin, anticoagulant) in the processed blood. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 89 Note: Emergency Mode and Quick Transfer cannot be directly selected when in Manual Mode. To switch to Emergency Mode or Quick Transfer Mode from Manual Mode: a. Touch Active Settings to open the drop-down list. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 90 1. Touch Wash. The volume of wash solution required depends upon factors such as the degree of hemodilution and amount of AC solution used. Certain minimum ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 91 Fill, Wash or Concentration phase. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 92: Processing A Partial Bowl
Attention: Unless the bowl is completely empty, keep fluid level in the waste bag ABOVE the 1 liter mark on the waste bag. This prevents air loss. Drain the waste fluid into an empty container for discard. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 93: General Precautions When Reinfusing Processed Blood
2. Touch End Procedure. A confirmation screen appears. 3. Touch End Procedure and wait for the device to empty the bowl (if full) and purge the blue line. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 94: Changing The Bowl Size During A Procedure
Records screen, view the procedure record, and edit the processing set on the Disposables tab, following the instructions on page 143. During a Procedure ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 95: Completing A Procedure
Note: If the device is powered off without purging the blue line and is powered on again within six hours with a processing set installed, the device prompts ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 96: Additional Functions
May cause fatal infusion of air. To purge any extra air from the RBC bag, you can touch Remove Air. A yellow alert message appears: ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 97 Standby mode. You can then choose to continue the procedure by touching one of the phase pads. To end the procedure again, touch Procedure Complete. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 98: Performing The Postoperative Cell Salvage Procedure
1. Reservoir connection 2. Wound drain connection Figure 47, Example of a post-op set ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 99: Installing The Post-Op Set After Intra-Op Use
3. Power off the device and disconnect it from power. Note: Do not touch End Procedure. 4. Lower the IV poles as far as possible. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 100: Installing The Postoperative Set For Post-Op Only Use
8. Set the appropriate suction level. (The default suction level is 75 mmHg.) 9. If processing is necessary, load the processing set. (See “Installing the Processing Set” on page 79.) ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 101 Removing the Plasma Product .......120 Removing the Sequestration and Processing Sets ....121 ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 102: Preparing The Cell Saver Elite+ Device
A power cord is supplied with the device. Do not replace the power cord with a substitute. If necessary, contact the Haemonetics Customer Care Center for a replacement. Always ensure the power cord is connected to an appropriately grounded power source.
Page 103: Unfolding The Biohazard Waste Bag
AC power. Remove and replace the bag only if it is found to be contaminated with blood or fluid. See “Replacing the Biohazard Waste Bag” on page 159. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 104: Power-On Procedure
“Device Settings” on page 45 more information). To select a different settings group, touch (Menu), select Settings from the drop-down menu, and choose the desired settings group. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 105: Installing The Sequestration Disposable Components
The Processing screen appears. Note: Sequestration is not available with the 70 mL bowl set. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 106 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. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 107 3. Position the header arm around the top of the bowl. 4. Turn the latch on the header arm clockwise until it locks into place. 5. Spin the bowl to ensure it spins freely. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 108 1. Hang the waste bag on the pins on the left side of the device. 2. Verify that the waste bag is securely connected to the effluent line. 3. Ensure that the waste bag drain port is completely closed. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 109: Installing The Blood Bag Adaptor Harness
Sequestration procedure, the adaptor harness does not need to be connected to a reservoir. In this case, the slide clamp on the port that would connect to the adaptor harness should be closed. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 110: Installing The Collection Bag Harness
6. Hang the air bag on the remaining waste bag pin. 7. Close the red ratchet clamps on the collection bags. 8. Ensure that the white ratchet clamps are open. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 111: Inspecting The Installation
2. Verify that all connections are secure and all appropriate clamps are closed. 3. Close the device cover, ensuring that no tubing is inadvertently clamped off. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 112: Performing A Sequestration Procedure
What clamps to open and ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 113: Collecting Ppp
Note: The white, blue, and yellow clamps should never be closed at the same time. Note: The prompts below correspond to the Haemonetics default settings and may appear differently if using other parameters. 3. Check that the red ratchet clamps on the collection bags are closed.
Page 114 (made up of platelets and white cells), which is immediately adjacent to the top of the RBC layer, reaches the shoulder of the bowl. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 115: Collecting Prp
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). ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 116: Emptying The Bowl
RBCs from the RBC bag into the bowl, to fill the bowl and push the PPP and PRP into their respective collection bags. The device will display a prompt, indicating the proper position of the clamps. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 117: Ending The Sequestration Protocol Early
2. Touch End Procedure. A prompt appears on the screen. 3. Touch End Procedure to end or Resume Procedure to resume. Figure 61, Ending Sequestration early ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 118: Changing To A Cell Salvage Procedure
Open the reservoir drain port clamp. h. Ensure that the slide clamp on the blood bag harness is open. i. Touch Cell Salvage to continue to Cell Salvage. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 119: Completing The Sequestration Cycle
When the blue line has been fully purged, a “Procedure Complete” message appears. Note: Haemonetics does not recommend resuming a Sequestration procedure after marking it completed. Note: To begin a new procedure, you must first power down the device and power it back on.
Page 120: General Precautions When Transferring The Rbcs For Reinfusion
4. Close the green clamp on the collection bags. 5. Close the white, blue and yellow clamps. 6. Label the PPP/PRP product with the following minimum information: ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 121: Removing The Sequestration And Processing Sets
If you choose to end the procedure without performing a Cell Salvage Sequestration procedure, remove the Sequestration and processing sets from the device and dispose of them according to local standard operating procedures. and Processing Sets ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 123 Parameters ..........134 Making the Quick Transfer and Manual Mode Settings Available ..136 ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 124: Overview
2. Select Settings from the drop-down list. The Settings screen appears. Figure 64, Example of the Settings screen Touch Cell Salvage or Sequestration to access the settings groups for the corresponding protocol. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 125: Working With Settings Groups
Lock a settings group  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 groups cannot be changed. Creating a New Once you have accessed the Settings screen, follow the steps below to create...
Page 126: Editing A Settings Group
Parameters that have been changed from the default setting will have a dot next to the value. 6. To reset a setting to its default value, select the setting and touch Default. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 127: Locking A Settings Group
To unlock a settings group: 1. From the Settings screen, select the settings group. 2. Touch View. The parameter list appears. 3. Touch Unlock. A keyboard appears. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 128: Applying A Settings Group
Follow the steps below to delete a settings group: Settings Group 1. Select the settings group to delete. 2. Touch Delete. 3. Touch Confirm. Note: The active, Haemonetics Default, and Fat Reduction settings groups cannot be deleted. ® ® ®...
Page 129: Modifiable Settings
Protocol Settings Modifiable Settings Default Settings The following tables list the Haemonetics default settings for the Cell Saver Elite+ device: Cell Salvage Default Settings Table 15, Cell Salvage Default Settings Parameter Values Default Notes Fat Reduction On/Off Auto-Fill On/Off Partial Bowl Wash...
Page 130 Cell Salvage - Manual Mode Default Settings Table 16, Cell Salvage - Manual Mode Default Settings Parameter Value Default Recentrifuge Delay On/Off Alert Sounds On/Off ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 131 2450 2450 2050 5650 Speed (RPM) Empty Pump Rate 500/400/100 300/150/100 1000 (mL/min) PRP Extend Volume (mL) PRP Milk Volume (mL) PRP Milk Delay (seconds) ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 132: Cell Salvage Settings
Determines if Quick Transfer is available via the Active Settings drop-down list. For more information, see “Emergency Options” on page 85 “Quick Transfer Mode” on page ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 133 Off: The device omits the Last Partial Bowl Wash.  End Procedure (On/Off)  Off: The only option is to end the procedure immediately.  ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 134: Parameters
Off: The pump empties fluid at a constant speed, which the user can  adjust via the +/- pads from 25 mL/min to 1000 mL/min (default is 100 mL/min). ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 135 Empty phase and to account for volume returned. If you select “Yes,” the PPP is returned to the bowl and then to the RBC bag along with the RBCs. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 136: Making The Quick Transfer And Manual Mode Settings Available
“Creating 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 Mode setting available: 1.
Page 137 Exporting Records ......... . .147 ® ® ® Haemonetics Cell Saver Elite + User Manual...
Page 138: Overview
By default, when you select Records from the Menu, the device displays the procedure record for the current procedure. To access a different record, touch History. The Records screen appears. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 139 140.); or you can touch Events or Device to view the event or device records (For more information, see “Event Records” on page 145 “Device Records” on page 146.). ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 140: Procedure Records
The Surgery Type, Surgeon, Patient ID, Operator ID, Visit ID, and Comment fields can be edited and will remain blank unless data is entered by the user. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 141 Note: If any IDs have barcodes, you can scan them using the barcode reader instead of manually entering the information. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 142: Volume By Cycle Tab
Conc volume for each cycle. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 143: Disposables Tab
3. Depending on the field selected, either scan the barcode of the item, select an entry from the drop-down list, or type the information using the keyboard and touch (Accept). ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 144: Events Tab
ID number, and a short description. To view the full event message, see “Event Messages” on page 166. Figure 72, Example of the Events tab ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 145: Event Records
1. Touch (Menu). 2. Select Records from the drop-down list. 3. Touch History. The Records screen appears. 4. Touch Events. Figure 73, Example of event records ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 146: Device Records
To access the device records: 1. Touch (Menu). 2. Select Records from the drop-down list. 3. Touch History. The Records screen appears. 4. Touch Device. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 147: Exporting Records
A “Data Transfer in Progress” message appears and disappears when the transfer is complete. Do not remove the USB flash drive until the data transfer is complete. Figure 75, Exporting data ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 148 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 serial number and procedure date and time. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 149 Performing a Search ........152 ® ® ® Haemonetics Cell Saver Elite + User Manual...
Page 150: Overview
Note: The Cell Saver Elite+ help system provides useful information on the operation and use of the device. It is not meant to be a substitute for the Cell Saver Elite+ User Manual. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 151: The Help System
To return to the previous list of main help topics, touch the heading at the top with the arrow to the left of it. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 152: Performing A Search
To perform a search: 1. Touch (Search). A keyboard appears. 2. Type a keyword(s) and touch (Accept). The search results appear on the left side of the screen. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 153 Help System Figure 78, Example of search results ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 155 Product Return Guidelines ........162 ® ® ® Haemonetics Cell Saver Elite + User Manual...
Page 156: Chapter 10, Cleaning And Maintenance
The user needs to perform routine cleaning 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 device depends on the number of procedures performed.
Page 157: Cleaning The Device
Personal protective equipment  If there is no established institutional policy for decontamination, Haemonetics recommends that blood spills be cleaned with a cleaning solution followed by a wipe down with distilled/sterile water. Use lint-free gauze or cloth to apply the cleaning solution and water.
Page 158 4. Open the device cover, remove the processing set and dispose of it in an appropriate biohazard protective bag. 5. If the fluid spill was caused by a leak in the disposable set, return the disposable set to Haemonetics for evaluation (see “Product Return Guidelines” on page 162).
Page 159: Replacing The Biohazard Waste Bag
The centrifuge base contains mechanical chuck clips which must be kept clean. The clips must be thoroughly cleaned after any spills (See “Blood Spill” ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 160: Cleaning The Fluid Detector
157). A dirty or blocked clip may no longer hold the bowl correctly in place. If a clip is not functioning properly, the user must contact the Haemonetics Customer Care Center. Cleaning the Clean the metallic surface of the fluid detector using a cotton swab moistened Fluid Detector with water.
Page 161: Replacing The Fuses
If the filter cover is damaged, contact the Haemonetics Customer Care Center for a replacement part.
Page 162: Customer Service
Chapter 10 Customer Service Note: In the continental U.S., the Haemonetics Customer Care Center may be reached by calling (800) 537-2802 or by emailing productsupport@haemonetics.com. For contact information, visit www.haemonetics.com/contact-support. Clinical Training Your local Haemonetics representative will provide staff training upon delivery of the Cell Saver Elite+ equipment and should be contacted to organize further instruction, if needed.
Page 163 Event Messages ..........166 ® ® ® Haemonetics Cell Saver Elite + User Manual...
Page 164: Troubleshooting Scenarios
Internal If the problem persists, install a turns on and off obstruction new vacuum line or use an intermittently. alternate suction source. Contact the Haemonetics Customer Care Center. Decreased Air Table 19, Troubleshooting Flow / Aspiration Problem Possible Cause Corrective Action...
Page 165: Touch Screen Problems
The device cover unlocks. does not unlock 2. Resolve any issue reported by when expected the event message. after an event message appears. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 166: Event Messages
Manifold Pressure Sensor Failure Explanation: An issue has been detected with the manifold pressure sensor. Corrective Action: Restart the device. If the problem persists, service is required. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 167 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. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 168 1. Touch Wash to enter the Wash phase OR 2. Touch  to continue filling the bowl OR 3. Touch Return to return cells to the reservoir. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 169 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. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 170 Air Detector Failure Explanation: An issue has been detected with the air detector. Corrective Action: Restart the device. If the problem persists, service is required. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 171 The salvaged blood may be reinfused to the patient. Cracked bowls should be reserved, reported and returned to the manufacturer. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 172 If the bowl size or processing set was changed: 1. Touch Yes. The device will display the Bowl Selection screen. 2. Follow the prompts on the screen. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 173 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. Power down the device. Service is required to fully resolve this issue. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 174 3. Touch Keep Bowl Size. If a Latham bowl is installed: 1. Touch Change Bowl Size. 2. Select the new bowl size or scan the processing set barcode. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 175 2. Touch Keep Bowl Size. If a Latham bowl is installed: 1. Touch Change Bowl Size. 2. Select the new bowl size or scan the processing set barcode. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 176 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 the processing set barcode. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 177 See service manual for additional information. System Fault Explanation: An issue has been detected with the system. Corrective Action: Restart the device. If the problem persists, service is required. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 178 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. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 179 2. Ensure the clamps on the yellow line are open and saline is connected. 3. Check the tubing placement in the air detector and pump. 4. Touch Continue to continue. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 180 4. If no spill is detected, once the centrifuge well has been dried, touch Retry. If the problem persists, service is required. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 181 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. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 182 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. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 183 An issue has been detected with the device memory during the power-on self-test (POST). Corrective Action: Restart the device. If the problem persists, service is required. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 184 An issue has been detected with the device's pneumatics system. It is unable to maintain adequate pressure. Corrective Action: Please service the device before continuing use. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 185 1. Connect an external regulated suction source to the reservoir. 2. Touch OK to close this message. Service is required to repair the internal suction. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 186 5. Close and latch the valve module cover. 6. Unclamp the lines. 7. Close the device cover. 8. Touch Continue to continue. If the problem persists, service is required. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 187 5. Close and latch the valve module cover. 6. Unclamp the lines. 7. Close the device cover. 8. Touch Continue to continue. If the problem persists, service is required. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 188 NOTE: When replacing the waste bag, make sure the bowl is empty. If the bowl is not empty, its contents will have to be returned to the reservoir and processed again. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 189 Touch Conc to continue filling the bowl with red cells from the RBC bag. Touch Wash to wash a partial bowl. Touch Return to return cells to the reservoir. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 190 1. Ensure that the bowl is seated properly. 2. Close and latch the centrifuge arm. 3. Close the device cover. If the problem persists, service is required. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 191 An issue has been detected with the device's pneumatics system. It is unable to maintain adequate pressure. Processing cannot continue. Corrective Action: Please service the device before continuing use. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 192 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. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 193 3. Ensure the spare reservoir ports are securely capped. 4. Check the reservoir for leaks. If the problem persists, external suction should be used and service is required to resolve this issue. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 194 1. Inspect the area around the blue line valve and clean if necessary. 2. Touch Continue to continue. If the problem persists, service is required. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 195 An issue has been detected with the calibration data for the load cells. Recalibration of the load cells is required. Corrective Action: Remove the device from service and recalibrate the load cells. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 196 Corrective Action: Inspect the area around the yellow line valve and clean if necessary. If the problem persists, service is required. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 197 A disposable must be loaded to begin a procedure. Corrective Action: 1. Load a disposable. 2. Touch Start Procedure when ready to begin a procedure. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 198 Stop Key Failure Explanation: An issue has been detected with the Stop key. Corrective Action: Restart the device. If the problem persists, service is required. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 199 Export of the data will have to be repeated. Corrective Action: 1. Ensure the storage device is securely installed in the USB port. 2. Touch Export to begin the data transfer. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 200 3. Touch Update to retry the update. 4. Do not remove the USB flash drive until the update is complete. If the problem persists, service is required. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 201 CAUTION: Overriding may cause red cells to spill into the waste bag due to incomplete separation of the cells in the bowl. Corrective Action: To override the delay and restart the pump now, touch . ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 202 Power was interrupted before the procedure was completed. Corrective Action: Touch Resume Procedure to resume the procedure in progress.  Touch New to start a new procedure.  ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 203 The blue line is being purged to the reinfusion bag. Purging will complete when air is detected from the bowl. Corrective Action: Wait for purging to complete. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 204 Records Exported to USB Flash Drive Explanation: The selected procedure record(s) and data log(s) have been exported to the USB flash drive successfully. The USB device can be safely removed. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 205 2. Check the tubing for kinks, occlusions, and proper placement in the air detector and pump. 3. Replace the saline bag if it is empty. 4. Touch Continue to continue. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 206 Data Transfer in Progress Explanation: The requested data transfer operation is in progress. Corrective Action: Wait for the operation to complete before removing the USB flash drive. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 207 • CLOSE the blue PRP line clamp. • CLOSE the yellow PPP line clamp. 2. Agitate the blood bag. 3. Touch Continue to fill the bowl. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 208 • CLOSE the white air line clamp. • OPEN the blue PRP line clamp. • CLOSE the yellow PPP line clamp. 2. Touch Continue to collect PRP. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 209 • OPEN the white air line clamp. • CLOSE the blue PRP line clamp. • CLOSE the yellow PPP line clamp. 2. Agitate the RBC bag. 3. Touch Continue to concentrate. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 210 The sequestration cycle has completed. Corrective Action: Touch Sequestration to sequester another unit. Touch Cell Salvage to prepare for Cell Salvage. Touch End Procedure to end the current procedure. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 211 Touch End Procedure to end the current procedure. System Fault Explanation: An issue has been detected with the system. Corrective Action: Restart the device. If the problem persists, service is required. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 212 Corrective Action: In order to end the specialized fat reduction cycle and execute a normal wash cycle, navigate to the Protocol Settings screen and activate Haemonetics 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, skipping fat reduction for this cycle.
Page 213 Confirmation is required to proceed. Corrective Action: Touch Update Software to continue the software update process. Touch Cancel to cancel the software update process. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 214 ID # Event Message Text Device Restart Is Required Explanation: The device must be restarted before continuing with normal operation. Corrective Action: Restart the device. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 215 Electromagnetic Compatibility ........217 ® ® ® Haemonetics Cell Saver Elite + User Manual...
Page 216: Operation Precautions
Electromagnetic Compatibility (EMC). A power cord is supplied with the device. Do not replace the power cord with a substitute. If necessary, contact the Haemonetics Customer Care Center for a replacement. Always ensure the power cord is connected to an appropriately grounded power source.
Page 217: Electromagnetic Compatibility
(for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 218 IEC/EN 61000-4-8 or hospital environment. NOTE: U is the AC mains voltage prior to application of the test level. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 219 If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system. b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 220 NOTE 1: At 80 MHz, the separation for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 221 As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used, because while it does not represent actual modulation, it would be worst case. ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 222 As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used, because while it does not represent actual modulation, it would be worst case. ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 223 Cell Salvage ..........224 ® ® ® Haemonetics Cell Saver Elite + User Manual...
Page 224 Lysate and heparin were added to measure constituent washout. Mean values are reported alongside standard error of the mean. System performance is summarized below based on bowl type and operating mode. Results may vary depending on in-use variables. Table 28, Haemonetics Default Parameter 225 mL Bowl 125 mL Bowl...
Page 225 99.7 ± 0.1 99.7 ± 0.0 a. Total protein measurement has been used as a surrogate instead of albumin only assay (albumin being a sub-category of protein). ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...
Page 227 Installing the Device on the Cart....... . .228 ® ® ® Haemonetics Cell Saver Elite + User Manual...
Page 228 Appendix C Installing the Device on the Cart ® ® ® P/N 130859-US, Manual Revision: AA Haemonetics Cell Saver Elite + User Manual...
Page 229 Cart Assembly Instructions ® ® ® Haemonetics Cell Saver Elite + User Manual P/N 130859-US, Manual Revision: AA...

Haemonetics Cell Saver Elite+ User Manual

Chapter 10, Cleaning and Maintenance

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