Haemonetics Cell Saver Elite User Manual
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Haemonetics Cell Saver Elite User Manual

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User manual
Not for use with software
prior to revision AM
0123
P/N 120745-IE, Manual revision: AA
June 2016

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  • Page 1 User manual Not for use with software prior to revision AM 0123 P/N 120745-IE, Manual revision: AA June 2016...
  • Page 2 © 2016, Haemonetics Corporation Notice The contents of this manual are the property of the Haemonetics Corporation. Any information or descriptions contained in this manual may not be reproduced and released to any of the general public, or used in conjunction with any professional instruction without written consent of Haemonetics Corporation, USA.
  • Page 3 The document is furnished for information use only, is subject to change Updates without notice and should not be construed as a commitment by Haemonetics Corporation. Haemonetics Corporation assumes no responsibility or liability for any errors or inaccuracies that may appear in the informational content contained in this material.
  • Page 5 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: Table Of Contents

    Communicable Disease Precautions......66 ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 7 Chapter 5, General Operation: Cell Salvage Preparing the Cell Saver Elite Device ......76 Connecting to Power .
  • Page 8 Chapter 6, General Operation: Sequestration Preparing the Cell Saver Elite Device ......100 Connecting to Power ........100 Positioning the Device .
  • Page 9 Cell Salvage ..........217 ® ® ® Haemonetics Cell Saver Elite User Manual...
  • Page 10 Appendix C: Assembling the Cart....... .219 ® ® ® P/N 120745-IE, 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

    ® ® The Cell Saver User Manual provides users with the information Elite needed to safely operate and maintain the Cell Saver Elite device and ensure Purpose of This optimal performance. Manual? The manual includes: Detailed descriptions of the device and all components ...

  • Page 13: Contraindications

    6 hours of collection. Contraindications Warning: The Cell Saver Elite device is not intended to be used for chest (pleural or mediastinal) wound drainage. Follow the guidelines for general autotransfusion contraindications per the AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma.

  • Page 14: 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 15 “Appendix B: System Performance” on page 217 for complete blood quality performance results for all bowl sizes and other settings, including Fat Reduction, Emergency mode, and partial bowl. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 16: Symbols

    Document Note: provides useful information regarding a procedure or operating technique when using Haemonetics material. Caution: 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 17 250 mmHg Maximum vacuum Pollution control mark Pollution control mark for products containing any of the six referenced substances (Lead, Mercury, Cadmium, etc...) according to Chinese regulations. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 18 Chapter 1, Introduction Storage conditions, humidity level Storage conditions, temperature level Storage conditions, keep dry Fragile, handle with care This end up Read the instruction manual ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 19: Device Specifications

    Device The Cell Saver Elite is classified as a continuous operation, Class I, Type CF, IPX1 device, as defined by IEC/EN 60601 standards for medical electrical Classification equipment.

  • Page 20: Electrical Specifications

    °C Atmospheric pressure range < 2438 meters (8000 ft.) Electrical The electrical specifications for operating the Cell Saver Elite device are as follows Specifications Caution: The Cell Saver Elite device must be operated in an environment compatible to the requirements of the IEC/EN 60601-1-2:2001 Standard, Electromagnetic compatibility (EMC).

  • Page 21: Suction Specifications

    Maximum free air flow 40 L/min Laser The Cell Saver Elite device is a class 3R laser product. Specifications The laser specifications for the Cell Saver Elite device are as follows: Table 8, Laser Specifications Characteristics Values Max radiation output...
  • Page 22 Chapter 1, Introduction a. The Cell Saver Elite device complies with IEC/EN 60825-1:2007 standard, safety of laser products, equipment classification and requirements. The following labels may appear on the device: ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver...

  • Page 23: Ordering Information

    Table 9, Disposables Ordering Information Item Description List Number Quantity Per Case Waste bag, 10 L CSE-B-1000 Cell Saver Elite processing set (70 mL) CSE-P-70 Cell Saver Elite processing set (125 mL) CSE-P-125 Cell Saver Elite processing set (225 mL) CSE-P-225 Sequestration set...
  • Page 24 70 mL centrifuge chuck adaptor 107581-00 Power cord, UK, 4.9m, 5A, 250VAC 109183-00 Power cord, European, 4.9m, 10A, 250VAC 109184-00 Printer kit 114282-00 User manual, IE 120747-IE ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 25 Step Plate ..........49 ® ® ® Haemonetics Cell Saver Elite User Manual...
  • Page 26 Removable Bins ......... . .49 ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 27: Overview

     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. 1. Device cover 2. Touch screen display 3. Effluent line sensor 4.

  • Page 28: 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. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 29: 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. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 30: Centrifuge System

    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 immediately. ®...
  • Page 31 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. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 32: Rear And Side Panel Components

    Storage Mount Vacuum The vacuum connection allows the user to connect the filtered vacuum line that leads to the reservoir. Connection ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 33: Power Cord

    The touch screen cable entry contains the cable that connects the device with the touch screen. Cable Entry Equipotential The equipotential ground terminal connection allows the user to connect the Cell Saver Elite device to other devices/equipment in the area, bringing them Ground to the same potential. Terminal Connection...

  • Page 34: Touch Screen Display

    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. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 35: Stop Key

    If a pad is grayed out it means that particular function is not currently available. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 36 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. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 37 (A&A) line in conjunction with a reservoir that has a maximum capacity of 3 liters. The Cell Saver Elite device has been calibrated to optimize SmartSuction performance with the use of Haemonetics proprietary disposables and recommended suction tips. Suction and fluid removal performance may decline if incorrect or non-Haemonetics disposables are used with the system.
  • Page 38 The menu options include: Cell Salvage  Sequestration (only available prior to starting the Cell Salvage protocol)  Settings  Records  System  Help  ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 39 If the device is in a paused or stopped state, you can touch the pad to resume the procedure. Grayed: The pad is disabled.  ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 40 (Accept) to save the change or (Cancel) to exit. 1. Decrease 2. Increase 3. Cancel 4. Accept Figure 13, Example of the Cycle Wash Volume box ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 41 To immediately stop the pumps, touch (Pause). To restart the current phase, touch (Play), or to start a different phase, touch the corresponding phase pad. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 42 The procedure statistics appear at the right of the procedure diagram and indicate the volume of salvaged fluid processed, volume of saline used, and volume of RBCs added to the RBC bag. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 43 Effluent Sensor Disabled: This icon appears if there has been a line  sensor failure and you have chosen to continue the procedure while monitoring the quality of the effluent. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 44 Emergency mode. During Emergency mode the device processes blood at high speeds. Emergency mode is not available when using a 70mL bowl disposable set. See “Emergency Mode” on page 87 for more information. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 45 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. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 46: Device Settings

    Chapter 2, Equipment Description Device Settings The System screen provides access to the Cell Saver Elite device settings. To access the System screen, touch (Menu) and select System from the drop-down menu. 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.
  • Page 47 Export Settings: Export all settings to a USB flash drive.  Software Update: View available software versions.  Import Settings: Select settings to import from a USB flash drive.  Haemonetics Technician Access Service: Access the manufacturing screens.  ® ® ®...

  • Page 48: Cart Components

    Chapter 2, Equipment Description Cart Components The Cell Saver Elite cart has four wheels that ensure maneuverability. The unit can be tipped back on the rear wheels to pass over power cords, door sills, and other obstructions. The Cell Saver Elite device can be removed from the cart to allow for easy transport in cars and vans.

  • Page 49: Wheels

    Note: The reservoir weigher ships with the Cell Saver Elite device but gets mounted on the cart as shown in...
  • Page 51 Sequestration Set..........59 ® ® ® Haemonetics Cell Saver Elite User Manual...

  • Page 52: Chapter 3, Disposable Set Description

    Chapter 3, Disposable Set Description Overview The Cell Saver Elite device utilizes 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: Reservoir ...

  • Page 53: Reservoir

    Figure 23, Example of a reservoir Note: Softshell reservoirs (LN 00300-MTSA and LN 00240-MTSA) must be used with the LN 00208-MT A&A line and the reusable reservoir holder 02100- ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 54: The A&A Line & Post-Op Set

    (A&A) line in conjunction with a reservoir that has a maximum capacity of 3 liters. The Cell Saver Elite device has been calibrated to optimize SmartSuction performance with the use of Haemonetics proprietary disposables and recommended suction tips. Suction and fluid removal performance may decline if incorrect or non-Haemonetics disposables are used with the system.

  • Page 55: Vacuum Line

    Chapter 3, Disposable Set Description Vacuum Line Caution: 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 56: Processing Set Elements

    The clear line passes through the pump, air detector, and valve module and enters the centrifuge well. Inside the well, the line connects to the inlet port of the bowl. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 57: Bags

    The effectiveness of the seal may be impaired if the bowl is incorrectly seated in the chuck. Fully seating the bowl in the centrifuge chuck will ensure proper function. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 58 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 immediately. The 70mL bowl requires a centrifuge chuck adaptor to correctly load the bowl.

  • Page 59: 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 120745-IE, Manual revision: AA...
  • Page 61 Sequestration ..........73 ® ® ® Haemonetics Cell Saver Elite User Manual...

  • Page 62: Chapter 4, Safety And Patient Care Precautions

    Storing and Warning: If the Cell Saver Elite device is stored at a temperature outside the Handling the operating temperature range, allow sufficient time for the device to equilibrate to room temperature before use.

  • Page 63: Transporting The Device

    The reservoir weigher should be no higher than 129 cm (51 in) from the floor during transport. 129 cm (51 in) Figure 31, Example of the IV poles in the transport position ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 64 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 65: Warnings For The User

    Always ensure the power cord is connected to an appropriately grounded power source. The Cell Saver Elite device must be operated in an environment compatible to the requirements of the IEC/EN 60601-1-2 Standard, Electromagnetic compatibility (EMC). Any accessories and cables not approved by Haemonetics used in conjunction with the device may increase hazards and influence compatibility with EMC requirements.

  • Page 66: Communicable Disease Precautions

    If any blood-contaminated material must be returned to Haemonetics for further inspection, see “Product Return Guidelines” on page 158.

  • Page 67: Preventing Problems During A Procedure

    It can also be caused by the use of non-isotonic wash solutions. The Cell Saver Elite device uses the effluent line sensor to check for the presence of excessive free hemoglobin during Wash. Wash will be extended if the free hemoglobin levels are not within an acceptable range.

  • Page 68: Avoiding Overheating

    ECG. If these conditions exist simultaneously, it is possible that the 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.
  • Page 69 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 70: Managing The Inventory Of Air

    1L mark on the waste bag. Within: • 6 mm (125 mL or 225 mL bowl) • 3 mm (70 mL bowl) ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 71: Patient Care Precautions

    Warning: DO NOT USE A PRESSURE CUFF OR ANY OTHER MECHANICAL Blood DEVICE WITH THE CELL SAVER ELITE SYSTEM. PRESSURE REINFUSION CAN RESULT IN THE FATAL INFUSION OF AIR INTO THE PATIENT. Warning: In accordance with applicable current guidelines and standards, a transfusion filter designed to retain particles that are potentially harmful to the patient should be used when returning processed concentrated red cells.

  • Page 72: Contraindications For Use

    Contraindications for Use Warning: The use of reinfused blood from the Cell Saver Elite device 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.

  • Page 73: Factors Affecting Processing Time

     All these factors combine to determine the total processing time for any Cell Salvage system. The Cell Saver Elite device has been programmed to optimize 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.
  • Page 75 General Operation: Cell Salvage Preparing the Cell Saver Elite Device ......76 Connecting to Power.

  • Page 76: Chapter 5, General Operation: Cell Salvage

    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 continuous operation, Class I, Type CF, IPX1 device, as defined by IEC/EN 60601 standards for medical electrical equipment.

  • Page 77: 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 155. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 78: Power-On Procedure

    “Device Settings” on page 46 (Menu), more information). To select a different settings group, touch select Settings from the drop-down menu, and choose the desired settings group. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 79: Installing The Cell Salvage Disposables

    2. Close the slide clamp on the reservoir drain port. 3. If using the Cell Saver Elite internal suction, connect the filtered vacuum line to both the vacuum port on the back of the device and to the vacuum inlet port on the reservoir.
  • Page 80 11. Allow approximately 150 mL of AC solution to flow into the collection reservoir to adequately prime the filter/defoamer media. 12. Close the roller clamp until beginning the collection from the field. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 81: Installing The Processing Set

    1. RBC bag 2. Large ratchet clamp 3. Small ratchet clamps Figure 36, RBC bag Installing the Tubing Harness To install the processing set tubing harness: ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 82 2. Ensure that the lower port of the bowl faces the effluent line sensor. 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 83 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 120745-IE, Manual revision: AA...

  • Page 84: Connecting The Reservoir

    1. 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 85: 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 120745-IE, Manual revision: AA...

  • Page 86: Performing The Intraoperative Cell Salvage Procedure

    Note: If the device loses power during the Empty cycle, touch Empty after recovering the procedure to ensure the bowl empties completely. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 87: Additional Functions

    Fill, Wash, Empty, Conc, and Return phases. It is not available from a Standby or Stopped state. To initiate Emergency mode: 1. Touch Emergency Mode. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 88: Processing A Partial Bowl

    1. Touch (Pause) to pause the procedure. 2. Remove the full waste bag. 3. Install a new waste bag. 4. Touch (Play) to resume the procedure. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 89: Reinfusing Processed Blood

    Warning: If reinfusing directly from the RBC bag, the slide clamp between the RBC bag and the patient MUST be closed between reinfusions. The white ratchet clamps on the blue line between the RBC bag and the Cell Saver Elite device MUST NOT be closed.

  • Page 90: Changing The Bowl Size During A Procedure

    Records screen, view the procedure record, and edit the Bowl Size processing set on the Disposables tab, following the instructions on page 136. During a Procedure ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 91: 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 120745-IE, Manual revision: AA...

  • Page 92: 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 93 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 120745-IE, Manual revision: AA...

  • Page 94: Performing The Postoperative Cell Salvage Procedure

    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 drainage, which you should not expose to suction levels greater than 100mmHg.

  • Page 95: Installing The Post-Op Set After Intra-Op Use

    Installing the Preparing the Device and Disposable Set Post-Op Set Note: For post-op suction, you must use the Cell Saver Elite internal post-op After Intra-Op suction levels or wall suction regulated to appropriate post-op suction levels. Caution: Do not activate post-op suction until the wound drain line is attached and the wound is closed.

  • Page 96: Transporting The Patient

    Chapter 5, General Operation: Cell Salvage 4. Open the wound drain clamps to the patient. Note: For post-op suction, you must use the Cell Saver Elite internal post-op suction levels or wall suction regulated to appropriate post-op suction levels. Caution: Do not activate post-op suction until the wound drain line is attached and the wound is closed.

  • Page 97: Installing The Postoperative Set For Post-Op Only Use

    90 cm (35.5 in.). 2. Ensure the anticoagulant bag is approximately the same height as the reservoir. 3. Connect the vacuum line to the Cell Saver Elite device and remove the clamp. 4. Connect the device to power and power it on.
  • Page 98 16. Open the wound drain clamps once the wound is closed. 17. If processing is necessary, load the processing set. (See “Installing the Processing Set” on page 81.) ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 99 General Operation: Sequestration Preparing the Cell Saver Elite Device ......100 Connecting to Power........100 Positioning the Device .

  • Page 100: Chapter 6, General Operation: Sequestration

    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 continuous operation, Class I, Type CF, IPX1 device, as defined by IEC/EN 60601 standards for medical electrical equipment.

  • Page 101: 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 155. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 102: Power-On Procedure

    “Device Settings” on page 46 (Menu), more information). To select a different settings group, touch select Settings from the drop-down menu, and choose the desired settings group. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 103: Installing The Sequestration Disposables

    Leave the port capped until ready to use. 3. If using the Cell Saver Elite internal suction, connect the filtered vacuum line to both the vacuum port on the back of the device and to the vacuum inlet port on the reservoir.
  • Page 104 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. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 105 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 120745-IE, Manual revision: AA...
  • Page 106 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 107: 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 120745-IE, Manual revision: AA...

  • Page 108: 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 109: 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 120745-IE, Manual revision: AA...

  • Page 110: Performing A Sequestration Procedure

    The system is first set up with 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 should be familiar with the operating instructions and all associated precautions and warnings for the device, in addition to any precautions and warnings specifically related to Sequestration provided in this chapter.

  • Page 111: 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 112: Collecting Prp

    The device displays another set of prompts when the buffy coat starts to exit the bowl. 1. Open the blue PRP line clamp and close the yellow PPP line clamp. 2. Touch Continue to begin collecting PRP. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 113: Emptying The Bowl

    RBCs. Bowl 1. Open the white air line clamp and close the blue PRP line clamp. 2. Touch Continue to start the Empty phase. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 114: Concentration During Sequestration

    You can choose to end the Sequestration procedure early. Follow the steps below to end the procedure early: Sequestration Protocol Early 1. Touch (Pause) to pause the procedure. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 115: Changing To A Cell Salvage Procedure

    Cell Salvage procedure. To end Sequestration early and change to Cell Cell Salvage Salvage: Procedure 1. Touch (Menu) and select Cell Salvage from the drop-down list. The device displays a confirmation message. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 116: Completing The Sequestration Cycle

    At the end of each Sequestration cycle, the device displays a prompt asking you whether to sequester another unit from the blood bag, prepare for a Cell Sequestration Cycle ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 117 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 118: Transferring The Rbcs For Reinfusion

    Warning: DO NOT USE A PRESSURE CUFF OR ANY OTHER MECHANICAL Reinfusion DEVICE WITH THE CELL SAVER ELITE SYSTEM. PRESSURE REINFUSION CAN RESULT IN THE FATAL INFUSION OF AIR INTO THE PATIENT. Warning: The safe length of time that blood or blood products may remain in the autotransfusion disposables is dependent on collection and storage methods.

  • Page 119: Removing The Sequestration And Processing Sets

    “for autologous use only”. These products should be stored separately and used solely for that purpose. If the Cell Saver Elite system has been set up for autotransfusion, the RBCs may be returned to the cardiotomy reservoir for later washing if desired.
  • Page 121 Parameters ..........130 ® ® ® Haemonetics Cell Saver Elite User Manual...

  • Page 122: Chapter 7, Protocol Settings

    Chapter 7, Protocol Settings Overview The Cell Saver Elite Settings screen provides an easy-to-use interface for changing and saving protocol settings. Using the Settings screen, you can pre- configure multiple settings and save 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.

  • Page 123: Working With Settings Groups

    Apply a settings group 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 groups cannot be changed. Creating a New...

  • Page 124: Editing A Settings Group

    Note: If you navigate to a different screen without touching Done, your changes will still be saved. All changes will take place immediately, except target volume ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 125: Locking 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 126: Modifiable Settings

    Chapter 7, Protocol Settings Modifiable Settings Default Settings Table 11, “Default Settings” displays the Haemonetics default settings for the Cell Saver Elite device: Table 11, Default Settings Cell Salvage Parameter Values Default Fat Reduction On/Off Auto-Fill On/Off Auto-Wash On/Off/Ask/ Skip...

  • Page 127: Cell Salvage Settings

    On: The device performs three additional steps during the Wash phase  that isolate the fat and remove it from the bowl. Off: The device performs a normal Cell Salvage Wash phase.  ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 128 Wash was entered prior to filling the bowl, and prompts you to double the wash volume, continue with the normal amount of saline solution, or end the procedure. You may also continue ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 129 Final Cycle (On/Off) Determines the End Procedure behavior when air is detected during Fill. On: The final cycle options (Concentrate, Wash, End Procedure) are  available. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 130: Parameters

    Fill Centrifuge Speed: The approximate rate at which the centrifuge  turns while the bowl is filling with whole blood and during the PPP collection phase ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 131 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 120745-IE, Manual revision: AA...
  • Page 133 Exporting Records ......... . . 143 ® ® ® Haemonetics Cell Saver Elite User Manual...

  • Page 134: Chapter 8, Records

    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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 135 136.); or you can touch Events or Device to view the event or device records (For more information, see “Event Records” on page 141 “Device Records” on page 142.). ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 136: 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 137: Volume By Cycle Tab

    The Volume By Cycle tab displays procedure statistics by cycle, including processed volume, wash volume, reinfusion volume, concentrate volume, and Cycle Tab for Sequestration PPP and PRP volume. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 138: Disposables Tab

    (REF), lot number, and expiration date. This information can be entered using the barcode reader from the Bowl Selection screen when the device is first powered or from the Disposables tab. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 139 Deleting an Item from the Disposables Record To delete an item from the disposables record: 1. Select the item you want to delete. 2. Touch Delete. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 140: Events Tab

    ID number, and a short description. To view the full event message, see “Event Messages” on page 162. Figure 71, Example of the Events tab ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 141: Event Records

    1. Touch (Menu). 2. Select Records from the drop-down list. 3. Touch History. The Records screen appears. 4. Touch Events. Figure 72, Example of event records ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...

  • Page 142: Device Records

    Figure 73, Example of 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 143: Exporting Records

    Chapter 8, Records Exporting Records The Cell Saver Elite device allows you to export procedure records from the last 100 procedures to a USB flash drive using the Records screen. Note: Export/Export All only appears if the USB flash drive is properly connected to the system, and the USB flash drive must be FAT-formatted.
  • Page 144 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 145 Performing a Search ........148 ® ® ® Haemonetics Cell Saver Elite User Manual...

  • Page 146: Chapter 9, Help System

    Chapter 9, Help System Overview The Cell Saver Elite device is equipped with a help system that provides information on the device and protocols. The help system features a search function and includes the following help topics: Disposable Setup ...

  • Page 147: 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 120745-IE, Manual revision: AA...

  • Page 148: Performing A Search

    4. Subtopics 5. Scroll bar Figure 76, Example of help subtopics Performing a The Cell Saver Elite help system includes a search feature, which allows you to search the help content by keyword. Search To perform a search: 1. Touch (Search).
  • Page 149 Chapter 9, Help System Figure 77, Example of search results ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 151 Product Return Guidelines ........158 ® ® ® Haemonetics Cell Saver Elite User Manual...

  • Page 152: Chapter 10, Cleaning And Maintenance

    Cleaning Caution: Do not immerse any part of the Cell Saver Elite device in liquids. Supplies Caution: Do not use solvents, strong alcohol solutions, or abrasive cleaning agents.

  • Page 153: 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 154 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 158).

  • Page 155: Replacing The Biohazard Waste Bag

    The clips must be thoroughly cleaned after any spills (See “Blood Spill” on page 153). 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 local Haemonetics representative. ® ® ® Haemonetics...

  • Page 156: Cleaning The Fluid Detector

    5. Place on a clean cloth and allow to dry completely. 6. Reinsert the dry filter in the filter panel, ensuring that the filter completely covers the opening. 7. Record the date of maintenance. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 157: Replacing The Fuses

    If the filter cover is damaged, contact the local Haemonetics representative for a replacement part. Warning: Follow local standard operating procedure for blood precautions when dealing with blood contaminated components.

  • Page 158: Customer Service

    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. Repair Service Haemonetics maintains a worldwide network of company-trained service representatives responsible for responding to technical needs concerning equipment.
  • Page 159 Event Messages..........162 ® ® ® Haemonetics Cell Saver Elite User Manual...

  • Page 160: Chapter 11, Troubleshooting

    Internal If the problem persists, install a turns on and off obstruction new vacuum line or use an intermittently. alternate suction source. Contact the local Haemonetics representative. Decreased Air Table 13, Troubleshooting Flow / Aspiration Problem Possible Cause Corrective Action...

  • Page 161: 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 120745-IE, Manual revision: AA...

  • Page 162: 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 163 Sensor Input Failure 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 120745-IE, Manual revision: AA...
  • Page 164 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 165 Replace the blood bag and 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. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 166 3. Touch Continue to continue. 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 167 An issue has been detected with the barcode reader. Scanning has been disabled. Corrective Action: 1. Enter information manually using the Records screen. 2. Touch OK to close this message. Service is required to repair the barcode reader. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 168 If the A&A line is not clamped the vacuum level may exceed the selected vacuum level and affect performance of the device. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 169 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. To end the procedure: 1. Touch End Procedure Service is required to fully resolve this issue. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 170 3. Touch Keep Bowl Size. If a 70 mL bowl is installed: 1. Touch Change Bowl Size. 2. Select the new bowl size or scan the processing set barcode. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 171 1. Check the bowl and chuck adaptor for proper installation in the centrifuge. 2. Touch Change Bowl Size. 3. Select the new bowl size or scan the processing set barcode. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 172 Waste Bag Load Cell Calibration Failure Explanation: •The waste bag load cell calibration values are out of the acceptable range. •Retry calibration. Corrective Action: See service manual for additional information. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 173 If the problem persists, service is required. Centrifuge Slowing Explanation: The procedure is waiting for the centrifuge to decelerate. Centrifuge Stopping Explanation: The procedure is waiting for the centrifuge to decelerate. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 174 If the problem persists, service is required. Pump Communication Failure Explanation: An issue has been detected with the pump. Corrective Action: Restart the device. If the problem persists, service is required. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 175 Device Cover Open Explanation: The device cover is open. The device cover must be closed and locked for the procedure to continue. Corrective Action: Close the device cover. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 176 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. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 177 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. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 178 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. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 179 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 120745-IE, Manual revision: AA...
  • Page 180 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 181 Corrective Action: 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 120745-IE, Manual revision: AA...
  • Page 182 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 183 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 120745-IE, Manual revision: AA...
  • Page 184 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 185 To end the procedure: 1. Touch End Procedure. 2. If in the power-on self-test, power down the device. If the problem persists, service is required to resolve this issue. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 186 Explanation: An issue has been detected with the waste bag sensor calibration during the power-on self-test (POST). Corrective Action: Please service the device before continuing use. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 187 Please service the device before continuing use. Software Version Error: Explanation: An issue has been detected with the SmartSuction software version during power-up. Corrective Action: Please service the device before continuing use. ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 188 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 189 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 120745-IE, Manual revision: AA...
  • Page 190 Corrective Action: 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 191 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 120745-IE, Manual revision: AA...
  • Page 192 Corrective Action: Inspect the area around the yellow line valve and clean if necessary. If the problem persists, service is required. ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 193 Explanation: 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 120745-IE, Manual revision: AA...
  • Page 194 Add a group again and enter a name that contains valid characters. 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 195 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 120745-IE, Manual revision: AA...
  • Page 196 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 197 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 120745-IE, Manual revision: AA...
  • Page 198 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 199 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 120745-IE, Manual revision: AA...
  • Page 200 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 201 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 120745-IE, Manual revision: AA...
  • Page 202 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 203 •OPEN the white air line clamp. •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 120745-IE, Manual revision: AA...
  • Page 204 1. Set the bag line clamps as follows: •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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 205 •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 120745-IE, Manual revision: AA...
  • Page 206 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 207 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 120745-IE, Manual revision: AA...
  • Page 208 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 209 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 120745-IE, Manual revision: AA...
  • Page 210 Table 16, Event Messages 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 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...
  • Page 211 Appendix C: Assembling the Cart ....... 219 ® ® ® Haemonetics Cell Saver Elite User Manual...

  • Page 212: Chapter 12, Reference Information

    EMC requirements. Therefore, non-approved accessories and cables must not be used. In addition, the Cell Saver Elite device and accessories must not be placed directly adjacent to, or on top of other equipment, unless specifically approved by Haemonetics.

  • Page 213: Electromagnetic Compatibility

    Table 17, Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Cell Saver Elite system is intended for use in the electromagnetic environment specified below. The customer or user of the Cell Saver Elite device should ensure that it is used in such an environment.
  • Page 214 Table 18, Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Cell Saver Elite system is intended for use in the electromagnetic environment specified below. The customer or user of the Cell Saver Elite device should ensure that it is used in such an environment. Immunity Test...
  • Page 215 Table 19, Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Cell Saver Elite system is intended for use in the electromagnetic environment specified below. The customer or user of the Cell Saver Elite system should ensure that it is used in such an environment. Immunity Test...
  • Page 216 Table 20, Recommended separation distance between portable RF communications equipment and the Cell Saver Elite device The Cell Saver Elite system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Cell Saver Elite system can help prevent...

  • Page 217: Appendix B: System Performance

    Cell Salvage In accordance with ANSI/AAMI AT6:2005, laboratory studies were conducted to confirm the performance of the Cell Saver Elite device. The following test results are based on two-cycle procedures processing 10% hematocrit test pools. Lysate and heparin were added to measure constituent washout. Mean values are reported alongside standard error of the mean.
  • Page 218 Albumin Washout % 99.9 + 0.003 99.95 + 0.003 Potassium Washout % 93.9 + 0.06 94.2 + 0.06 Heparin Washout % 99.2 + 0.01 99.2 + 0.01 ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

  • Page 219: Appendix C: Assembling The Cart

    Chapter 12, Reference Information Appendix C: Assembling the Cart ® ® ® Haemonetics Cell Saver Elite User Manual P/N 120745-IE, Manual revision: AA...
  • Page 220 Chapter 12, Reference Information ® ® ® P/N 120745-IE, Manual revision: AA Haemonetics Cell Saver Elite User Manual...

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