Operation Manual
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User manual
Not for use with software prior to revision AM P/N 120745-US(AA) June 2016
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Publication Information
Publication Information Publication Date
June 2016
Part Number
120745-US
Copyright Notice
© 2016, Haemonetics Corporation
Confidential/ Proprietary Notices
Use of any portion(s) of this document to copy, translate, disassemble or decompile, or create or attempt to create by reverse engineering (or otherwise) the source code from the object code of Haemonetics products is expressly prohibited.
Disclaimer
This manual is intended as a guide to provide the user with necessary instructions on the proper use and maintenance of certain Haemonetics Corporation products. This manual should be used in conjunction with instruction and training supplied by qualified Haemonetics personnel.
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.
Any failure to follow the instructions as described, including use of materials or products not provided or recommended by Haemonetics, could result in impaired product function, injury to the user or others, or void applicable product warranties. Haemonetics accepts no responsibility for liability resulting from improper use or maintenance of its products. Utilization of Haemonetics products may require the user to handle and dispose of blood-contaminated material. Users must fully understand and implement all regulations governing the safe handling of blood products and waste, including the policies and procedures of their facility. Handling and use of any blood products collected or stored using Haemonetics equipment are subject to the decisions of the attending physician or other qualified medical personnel. Haemonetics makes no warranty with respect to such blood products.
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Haemonetics® Cell Saver® Elite® User Manual
Publication Information
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Patient diagnosis is the sole responsibility of the attending physician or other qualified medical personnel. The screenshots appearing in this manual are provided for illustrative purposes only and may differ from the actual software screens. All organization, donor/ patient, and user names in this manual are fictitious. Any similarity to the name of an organization or person is unintentional.
Document Updates
The document is furnished for information use only, is subject to change 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. For the purpose of clarity, Haemonetics Corporation considers only the most recent version of this document to be valid.
Trademarks and Patents
Haemonetics, Cell Saver, Elite, and SmartSuction are trademarks or registered trademarks of Haemonetics Corporation in the United States and/or other countries. Microsoft, Excel, and Coverage Plus NPD are trademarks or registered trademarks of their respective owners.
Reader Comments
Any comments or suggestions regarding this publication are welcomed and should be forwarded to the attention of: Corporate Headquarters Haemonetics Corporation 400 Wood Road Braintree, MA 02184 U.S.A. Tel.: +1 781 848 7100 Fax:+1 781 848 5106
International Headquarters Haemonetics S.A. Signy Centre Rue des Fléchères 6 P.O. Box 262 1274 Signy-Centre Switzerland Tel.: +41 22 363 9011 Fax:+41 22 363 9054
Rx Only
Caution: USA Federal Law restricts the sale, distribution, or use of this device to, by, or on the order of a licensed healthcare practitioner.
Haemonetics Worldwide
Please direct any written inquiries to the appropriate address. For a list of worldwide office locations and contact information, visit www.haemonetics.com/officelocations.
Haemonetics® Cell Saver® Elite® User Manual
P/N 120745-US(AA)
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?... 12 Indications for Use... 12 Contraindications... 13 Features of the Cell Saver Elite System... 13 Blood Product Quality... 14 Symbols... 16 Symbols Found in This Document... 16 Symbols Found on the Device... 16 Device Specifications... 19 Device Classification... 19 Physical Specifications... 19 Environmental Specifications... 19 Electrical Specifications... 20 Suction Specifications... 21 Laser Specifications... 21 Ordering Information... 23
Chapter 2, Equipment Description Overview... 27 Top Deck and Front Panel Components... 28 Device Cover... 28 Effluent Line Sensor... 28 Air Detector... 28 Pump... 28 Handle... 28 Valve Module... 29 Centrifuge System... 30 Rear and Side Panel Components... 32 Waste Bag Weigher... 32 Air Intake... 32 Air Exhaust Filter... 32 Touch Screen Storage Mount... 32 Vacuum Connection... 32 Touch Screen Cable Entry... 33 Equipotential Ground Terminal Connection... 33 Reservoir Weigher Connection... 33 Power Entry Module... 33
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Table of Contents
Power Cord...33 Touch Screen Display...34 Status Beacon...34 Barcode Reader...34 Stop Key...35 Touch Screen Mount...35 USB Connection...35 Graphical User Interface...35 Device Settings...46 Cart Components...48 IV Poles...48 Device Mount...48 Wheels...49 Reservoir Weigher...49 Saline Hangers...49 Handle...49 Processing Set Tub Holder...49 Step Plate...49 Removable Bins...49
Chapter 3, Disposable Set Description Overview...52 Reservoir...53 The A&A Line and Post-Op Set...54 A&A Line...54 Post-Op Set...54 Vacuum Line...55 Processing Set Elements...56 Tubing Harness...56 Bags...57 Centrifuge Bowl...57 Sequestration Set...59
Chapter 4, Safety and Patient Care Precautions Storing and Handling the Device and Disposables...62 Storing and Handling the Device...62 Storing and Handling the Disposables...62 Inspecting the Components...62 Transporting the device...63 Warnings for the User...65 Electrical Shock Hazards...65 Leakage Current Control...65 Power Outlet Connection...65 Laser Radiation Hazards...65 Mechanical Hazards/Rotating Parts...65 Communicable Disease Precautions...66
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Preventing Problems During a Procedure...67 Understanding the Risk of Hemolysis...67 Avoiding Flow Restrictions...67 Avoiding Overheating...68 Avoiding Continuous Aspiration...68 Avoiding Red Blood Cell Spillage...68 Managing the Inventory of Air...70 Patient Care Precautions...71 Reinfusing Blood...71 Replacing Depleted Clotting Factors...71 Contraindications for Use...72 Using Anticoagulants...72 Factors Affecting Processing Time...73 Cell Salvage...73 Sequestration...73
Chapter 5, General Operation: Cell Salvage Preparing the Cell Saver Elite Device...76 Connecting to Power...76 Positioning the Device...76 Unfolding the Biohazard Waste Bag...77 Power-on Procedure...78 Installing the Cell Salvage Disposables...79 Inspecting the Disposable Sets...79 Collect First Setup...79 Installing the Processing Set...81 Connecting the Reservoir...84 Setting up the Saline Solution...85 Inspecting the Installation...85 Performing the Intraoperative Cell Salvage Procedure...86 Initiating a Procedure...86 Procedure Overview...86 Additional Functions...87 Processing a Partial Bowl...88 Monitoring the Waste Bag...88 Reinfusing Processed Blood...89 Changing Processing Sets During a Procedure...90 Changing the Bowl Size During a Procedure...90 Completing a Procedure...91 Additional Functions...92 Performing the Postoperative Cell Salvage Procedure...94 Post-Op Set...94 Installing the Post-Op Set After Intra-Op Use...95 Transporting the Patient...95 Installing the Postoperative Set for Post-Op Only Use...96
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Table of Contents
Chapter 6, General Operation: Sequestration Preparing the Cell Saver Elite Device...98 Connecting to Power...98 Positioning the Device...98 Unfolding the Biohazard Waste Bag...99 Power-on Procedure...100 Installing the Sequestration Disposables...101 Inspecting the Disposable Sets...101 Loading the Reservoir and Vacuum Line...101 Installing the Processing Set...101 Installing the Blood Bag Adaptor Harness...105 Installing the Collection Bag Harness...106 Inspecting the Installation...107 Performing a Sequestration Procedure...108 Procedure Overview...108 Processing from Blood Bags...108 Initiating a Procedure...108 Collecting PPP...109 Collecting PRP... 110 Emptying the Bowl... 111 Concentration During Sequestration... 112 Ending the Sequestration Protocol Early... 112 Changing to a Cell Salvage Procedure... 113 Completing the Sequestration Cycle... 114 Transferring the RBCs for Reinfusion... 116 Removing the Plasma Product... 116 Removing the Sequestration and Processing Sets... 117
Chapter 7, Protocol Settings Overview...120 Working with Settings Groups...121 Creating a New Settings Group...121 Editing a Settings Group...122 Locking a Settings Group...123 Applying a Settings Group...123 Deleting a Settings Group...123 Modifiable Settings...124 Default Settings...124 Cell Salvage Settings...125 Parameters...128
Chapter 8, Records Overview...132 Procedure Records...134 Record Tab...134 Volume By Cycle Tab...135
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Disposables Tab...136 Events Tab...138 Event Records...139 Device Records...140 Exporting Records...141
Chapter 9, Help System Overview...144 The Help System...145 Accessing the Help System...145 Navigating the Help Menu...145 Performing a Search...146
Chapter 10, Cleaning and Maintenance Cleaning and Maintenance...150 Cleaning/ Maintenance Schedule...150 Cleaning Supplies...150 Cleaning the Device...151 Replacing the Biohazard Waste Bag...153 Cleaning the Optical Lenses...153 Cleaning the Centrifuge Well...153 Cleaning the Fluid Detector...154 Cleaning the Pump...154 Washing/Replacing the Air Filters...154 Replacing the Fuses...155 Inspecting the Power Cord...155 Customer Service...156 Clinical Training...156 Repair Service...156 Product Return Guidelines...156
Chapter 11, Troubleshooting Troubleshooting Scenarios...158 Vacuum Problems...158 Decreased Air Flow / Aspiration Problems...158 Touch Screen Problems...159 Device Cover Problems...159 Event Messages...160
Chapter 12, Reference Information Appendix A: IEC/EN 60601-1-2:2007 Standard Requirements...210 Operation Precautions...210 Essential Performance...210 Electromagnetic Compatibility... 211 Appendix B: System Performance...215 Appendix C: Assembling the Cart...217
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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?... 12 Indications for Use... 12 Contraindications... 13 Features of the Cell Saver Elite System... 13 Blood Product Quality... 14 Symbols... 16 Symbols Found in This Document... 16 Symbols Found on the Device... 16 Device Specifications... 19 Device Classification... 19 Physical Specifications... 19 Environmental Specifications... 19 Electrical Specifications... 20 Suction Specifications... 21 Laser Specifications... 21 Ordering Information... 23
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Chapter 1, Introduction
The Haemonetics Cell Saver Elite Device What is the Purpose of This Manual?
The Cell Saver® Elite® User Manual provides users with the information needed to safely operate and maintain the Cell Saver Elite device and ensure optimal performance. The manual includes:
Detailed descriptions of the device and all components
How to safely operate the device and troubleshoot any difficulties
How to properly handle and maintain the device
Use this manual in conjunction with training supplied by qualified Haemonetics® personnel. This manual covers device list numbers CSE-E-US and CSE-EA-1000.
What is the Cell Saver Elite Autotransfusion System?
The Cell Saver Elite Autotransfusion System provides intraoperative and postoperative blood salvage for surgical procedures with medium to high blood loss. The shed blood is collected in a reservoir, processed in a centrifuge bowl to pack red blood cells (RBCs), and then washed to remove cell stroma, platelets, activated clotting factors, extracellular potassium, free hemoglobin, anticoagulant, and cardioplegia. The washed, packed RBCs are then pumped to a bag for gravity reinfusion to the patient, or, to the arterial line of an extracorporeal circuit for reinfusion to the patient. Prior to autotransfusion, the device can also sequester platelets using the autotransfusion disposable in conjunction with a Sequestration set. The Cell Saver Elite system consists of the following three parts:
Cell Saver Elite device: the electro-mechanical device and graphical user interface (GUI) touch screen.
Disposables: the single-use collection material including reservoir, aspiration and anticoagulant (A&A) line, processing set, vacuum line, and post-op lines.
Solutions: anticoagulant and saline for collecting and processing salvaged blood.
Indications for Use
The Haemonetics® Cell Saver® Elite® Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet
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rich plasma product for reinfusion to the same patient within 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. The risk/benefit ratio of blood salvage must be determined on an individual basis by the surgeons, anesthesiologists, and transfusion medicine specialists involved in the patient’s care. The use of reinfused blood from the Cell Saver Elite system may be contraindicated, for example, in the case of sepsis or malignancy. The responsibility for the use of this device belongs solely to the physician in charge.
Features of the Cell Saver Elite System
The Cell Saver Elite system includes key enhancements to the Cell Saver line of products that increase device capabilities and ease of use. These enhancements include:
Two suction options: on-board SmartSuction® technology and regulated on-board suction.
The ability to retain data for up to 100 procedures and continue a procedure after being powered down during transport from the operating room to the post-anesthesia care unit (PACU).
A built-in barcode reader to record disposable set(s), solutions, and operator/patient information.
The ability to download data using a USB flash drive.
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
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Blood Product Quality
Chapter 1, Introduction
Caution: Actual performance results may vary depending on many in-use variables. Haemonetics recommends using the following RBC product criteria for quality control procedures. Criteria are based on Haemonetics Default and standard fat reduction protocol settings in laboratory performance with 10% hematocrit blood pools. Table 1, RBC Product Criteria Criteria
Product Performance
HCT
> 40%
RBC Recovery
> 80%
Free Hemoglobin Washout
> 95%
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. Lysate and heparin were added to measure constituent washout. Results are listed below for test pools prepared both with and without lysate. Mean values are reported alongside standard error of the mean. Results may vary depending on in-use variables. Table 2, 225 mL Bowl Test Results Parameter
Without Lysate
With Lysate
HCT %
60 + 0.2
56 + 0.3
RBC Recovery %
94 + 1.0
95 + 0.1
WBC Removal %
24.7 + 5.01
39.6 + 9.92
-
98.8 + 0.06
97.7 + 0.16
97.8 + 0.06
-
96.4 + 0.16
99.6 + 0.01
99.8 + 0.003
Free Hemoglobin Washout % Albumin Washout % Potassium Washout % Heparin Washout % *Fat Washout %
99.6 + 0.13
*Fat reduction performance is applicable for the Fat Reduction setting.
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See “Appendix B: System Performance” on page 215 for complete blood quality performance results for all bowl sizes and other settings, including Fat Reduction, Emergency mode, and partial bowl.
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Chapter 1, Introduction
Symbols Symbols Found in This Document
The terms Note, Caution, and Warning are used in this manual with the following symbols to emphasize certain details for the user. 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; personal injury is unlikely. Warning: advises the user against initiating an action or creating a situation which could result in serious personal injury to the patient or user.
Symbols Found on the Device
The following symbols may appear on the device or device packaging. Caution Consult accompanying documents.
Type CF Type CF applied part provides a specific degree of protection against electric shock, particularly regarding allowable leakage current and reliability of the protective earth connection. Electrical and electronic equipment waste (applies to EU only) Dispose of the device using a separate collection method (according to EU and local regulation for waste electrical and electronic equipment). IPX1
Protection against ingress of vertically dripping water Indicates that the enclosure of the device is designed to be drip-proof, providing a higher than ordinary level of protection from drips, leaks and spills. Manufacturer
Alternating current
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Fuse
Equipotentiality Identifies the terminals which, when connected together, bring the various parts of a system to the same potential.
EC REP
Authorized representative in the European Community
Rx only (applies to USA only) Federal (USA) Law restricts the device to sale to or on the order of a physician. Serial number
REF
Catalog (list) number
Laser radiation
Shock hazard
General symbol for recovery/recyclable To indicate that a material is part of a recovery/recycling process. Note: Applicable only to those products or materials for which, at the end of life, there is a well-defined collection route and recycling process, and which does not significantly impair the effectiveness of other recycling schemes.
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.
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Chapter 1, Introduction
Storage conditions, humidity level
Storage conditions, temperature level
Storage conditions, keep dry
Fragile, handle with care
This end up
Follow the instructions for use.
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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 Classification
The Cell Saver Elite is classified as a continuous operation, Class I, Type CF, IPX1 device, in accordance with IEC/EN 60529 and 60601 standards for medical electrical equipment.
Physical Specifications
The approximate dimensions and weight of the Cell Saver Elite device are as follows:. Table 3, Physical Specifications Depth/in. (cm)
Height/in. (cm)
Width/in. (cm)
21.5 in. (54.6 cm)
16.5 in. (41.9 cm)
11.75 in. (29.8 cm
IV poles extended
26.5 in. (67.3 cm)
72 in. (182.9 cm) 21 in. (53.3 cm)
IV poles down
26.5 in. (67.3 cm)
48 in. (121.9 cm) 21 in. (53.3 cm)
Weight of device
56 lbs. (25 kg)
Weight of cart
39 lbs. (18 kg)
Device Alone Device With Cart
The noise level of the Cell Saver Elite device is < 70 dB.
Environmental Specifications
The following environmental conditions should be respected pertaining to operation and storage of the Cell Saver Elite device. Warning: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Note: Store disposables in a dry place away from solvent vapors and extremes of temperature.
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Chapter 1, Introduction
Table 4, Environmental Specifications
Electrical Specifications
Conditions
Values
Ambient operating temperature
10 °C to 27 °C (50 °F to 80.6 °F)
Storage/transportation temperature
-20 °C to 50 °C (-4 °F to 122 °F)
Operating humidity level
8 to 80% R.H., non-condensing above 0°C
Atmospheric pressure range
< 2438 meters (8000 ft.)
Pollution degree
Pollution degree 2
The electrical specifications for operating the Cell Saver Elite device are as follows. Caution: The Cell Saver Elite device must be operated in an environment compatible to the requirements of the IEC/EN 60601-1-2:2007 Standard, Electromagnetic compatibility (EMC). Additional IEC/EN compliance information is available in Chapter 12. Note: The power source used must be properly grounded. Table 5, Electrical Input Power Rated Voltage
Rated Current
Fuse
Frequency
100–120 V
3.0 A
T3.15A250V
50/60 Hz
200–240 V
1.5 A
T3.15A250V
50/60 Hz
Table 6, Enclosure/Chassis Leakage Current Specifications* Condition
Polarity
Ground
Max Value
Normal
Normal
Normal
100 µΑ
Reverse
Normal
100 µΑ
Reverse
Open
500 µΑ
Normal
Open
500 µΑ
Single Fault
*In accordance with IEC/EN 60601-1standard, medical electrical equipment, general requirements for safety.
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Suction Specifications
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The specifications for the Cell Saver Elite suction are as follows. Table 7, Suction Specifications Characteristics
Values
SmartSuction Recommended reservoir volume
≤3L
Recommended A&A line length
≤ 12 ft [3.6 m]
Recommended A&A line inner diameter
0.3 in [7.6 mm]
Recommended suction tip inner diameter
0.3 in [7.6 mm]
Operating vacuum
20 to 150 mmHg (2.7 to 20.0 kPa; 26.7 to 200 mbar)
Vacuum cutoff
175 mmHg (23.3 kPa; 233 mbar)
Maximum free air flow
40 L/min
Manual Suction Operating vacuum
50 to 250 mmHg (6.7 to 33.3 kPa; 66.7 to 333.3 mbar)
Maximum free air flow
40 L/min
Post-Op Suction
Laser Specifications
Operating vacuum
25 to100 mmHg (3.3 to 13.3 kPa; 33.3 to 133.3 mbar)
Maximum free air flow
40 L/min
The Cell Saver Elite device is a class 3R laser product. The laser specifications for the Cell Saver Elite device are as follows. Table 8, Laser Specifications Characteristics
Values
Max radiation output
3 mW
Wavelength
650 nm
Max light output
7 mW (bowl optics) 1.7 mW +/- 0.2 mW (barcode reader)
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Chapter 1, Introduction
Table 8, Laser Specifications Characteristics
Values
Standards
IEC/EN 60825-1:2007a 21 CFR 1040.10 and 1040.11b
a. The Cell Saver Elite device complies with IEC/EN 60825-1:2007 standard, safety of laser products, equipment classification and requirements. b. 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:
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Haemonetics® Cell Saver® Elite® User Manual