Cell Saver 5 + Operation Manual Rev B Jan 2005

Preface

IMPORTANT INFORMATION FOR THE CUSTOMER The contents of this manual are property of the Haemonetics Corporation. Haemonetics® and Cell Saver® are registered trademarks of 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. Please direct any written inquiries to the appropriate address: International Headquarters Haemonetics SA Signy Centre, rue des Fléchères P.O. Box 262, 1274 Signy 2, Switzerland Tel. [+41 22] 363 90 11 Fax [+41 22] 363 90 54

Corporate Headquarters Haemonetics Corporation 400 Wood Road Braintree, MA 02184, USA Tel. [+1 781] 848 7100 Fax [+1 781] 848 5106

Understanding the purpose of this manual This manual is intended for use as a guide, uniquely for material as supplied by the Haemonetics Corporation. It provides the operator with necessary information to safely carry out specific procedures and satisfactorily maintain Haemonetics produced equipment. The manual is to be used in conjunction with instruction and training as supplied by qualified Haemonetics personnel. Haemonetics guarantees its products when correctly used by a properly trained operator. Any failure to respect the procedures as described could result in impaired function of the equipment, as well as in injury to the operator and/or patient. When properly assembled, maintained and operated properly, the Cell Saver systems can safely and adequately perform various cell salvaging procedures. Haemonetics accepts no responsibility for problems resulting from failure to comply with prescriptions as outlined by the company. Any modifications estimated as necessary by the customer should be evaluated by a Haemonetics Clinical Specialist. Safe utilization of Haemonetics material and equipment requires the operator to correctly handle and dispose of blood-contaminated material. The operator of any Haemonetics equipment must fully understand and implement the local prevailing policies and procedures of each facility in which Haemonetics products are used, concerning blood-contaminated material as well as blood products. It remains solely the responsibility of the customer to fully assess and ensure the safety of any products obtained from Haemonetics prescribed procedures, prior to further application or use. Haemonetics declines any responsibility for choices made by the consumer concerning the utilization of these products and by-products. USA Federal Law restricts this device to sale by or on the order of a physician.

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Preface

Contacting Haemonetics worldwide The operator should consult the following alphabetical list containing all international branch addresses when contacting the appropriate Haemonetics representative for each locality. Haemonetics Asia Inc. Taiwan Branch 26F-1, No. 102 Roosevelt Road Sec. 2 Taipei, Taiwan Tel. [+886 2] 2369 0722 Fax [+886 2] 2364 3698 Haemonetics Handelsges.m.b.H. Berlagasse 45/B2-02 1210 Wien, Austria Tel. [+43 1] 294 29 00 Fax [+43 1] 294 29 05 Haemonetics Belgium NV Leuvensesteenweg 542-BP. 14 Planet II Complex 1930 Zaventem, Belgium Tel. [+32 2] 720 7484 Fax [+32 2] 720 7155 Haemonetics BV Tinstraat 107 4823 AA Breda The Netherlands Tel. [+31 76] 544 9477 Fax [+31 76] 544 9357 Haemonetics Medical Devices (Shanghai) International Trading Co. Ltd. Room 28032, Shanghai HSBC Tower 101 Yin Cheng East Road Shangai 200120, PRC Tel. [+86 21] 5066 3366 Fax [+86 21] 6841 3688

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Haemonetics CZ, spol. s r.o. Ptašínského C.8 60200 Brno, Czech Republic Tel. [+42 05] 4121 2400 Fax [+42 05] 4121 2399 Haemonetics France S.A.R.L. 46 bis, rue Pierre Curie Z.I. Les Gatines 78370 Plaisir, France Tel. [+33 1] 30 81 41 41 Fax [+33 1] 30 81 41 30 Haemonetics GmbH Rohrauerstrasse 72 81477 München, Germany Tel. [+49 89] 785 8070 Fax [+49 89] 780 9779 Haemonetics Hong Kong Ltd. Suite 1314, Two Pacific Place 88 Queensway, Hong Kong Tel. [+852] 2868 9218 Fax [+852] 2801 4380 Haemonetics Italia S.R.L. Via Donizetti 30 20020 Lainate (MI), Italy Tel. [+39 2] 9357 0113 Fax [+39 2] 9357 2132 Haemonetics Japan K.K. Kyodo Building 3F 16, Ichiban-cho, Chiyoda-ku Tokyo, Japan, 102-0082 Tel. [+81 3] 3237 7260 Fax [+81 3] 3237 7330

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Haemonetics Scandinavia AB Beta Huset, Ideon Scheelegatan 17 223 70 Lund, Sweden Tel. [+46 46] 286 2320 Fax [+46 46] 286 2321 Haemonetics (UK) Ltd. Beechwood House Beechwood Estate Elmete Lane, Roundhay Leeds LS8 2LQ, United Kingdom Tel. [+44 113] 273 7711 Fax [+44 113] 273 4055 Haemonetics SA Signy Centre, rue des Fléchères P.O. Box 262 1274 Signy 2, Switzerland Tel. [+41 22] 363 90 11 Fax [+41 22] 363 90 54

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Preface

UNDERSTANDING THE USE OF 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 operator. Note: Provides useful information regarding a procedure or operating technique when using Haemonetics material.

Caution: Advises the operator against initiating an action or creating a situation which could result in damage to equipment, or impair the quality of the by-products; personal injury is unlikely.

Warning: Advises the operator against initiating an action or creating a situation which could result in serious personal injury to either the donor or the operator.

!

Text preceded by this bullet indicates an item on a list of information for the operator.

"

Text preceded by this bullet indicates an action for the operator.

Symbols found on the device !

IEC 60601-1 Standard, Medical Electrical Equipment, Part 1: General requirements for safety.

!

IEC 60417-1 Standard, Graphical symbols for use on equipment, Part 1: Overview and application. Type BF applied part This symbol indicates that the applied portion (i.e. the part which comes in contact with the patient) of the device is electrically isolated. The device has an internal electrical power source providing adequate protection against electrical shock, in particular pertaining to acceptable leakage current and the reliability of the protective earth connection. Protective earth [ground] Used to identify any terminal intended for connection to an external conductor, for protection against electrical shock in case of a fault.

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~

Alternating current Used to indicate on the rating plate that the device is suitable for alternating current only. Fuse symbol Used to identify fuse boxes or the location of a fuse box. Power OFF Position of the main power switch indicating disconnection from the mains. Power ON Position of the main power switch indicating connection to the mains.

IPX1

Protection against ingress of liquid Indicates that the enclosure of the device is designed to provide a specified degree of protection against harmful ingress of water or liquid into the equipment (under applicable conditions). Attention (Consult accompanying documents)

Non-ionizing electromagnetic radiation Used to specify RF transmission for data communication.

Symbol found on the chuck adapter DO NOT DISCARD

The following symbols have been designed for devices manufactured by Haemonetics Bar-code reader connection

RS232 connection with power to one pin

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Symbols found on disposable packaging The following symbols are used by Haemonetics on disposable set packaging. Catalog number

REF

Expiration date

Lot number LOT

STERILE EO

Contents sterile by exposure to ethylene oxide

STERILE EO

Fluid path sterile by exposure to ethylene oxide

STERILE

R

Contents sterile by exposure to gamma irradiation

STERILE

R

Fluid path sterile by exposure to gamma irradiation

Do not reuse

Caution: consult operator manual for instructions

80%

Storage conditions, humidity level

50˚C

Storage conditions, temperature level

8%

-20˚C

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Fragile, handle with care

Bowl symbol chart During a procedure, the bowl icon on screen reflects the bowl size currently in use. See below for bowl sizes and corresponding icons.

70 mL bowl

125 mL bowl 125

225 mL bowl 225

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Table of contents Chapter One

Presenting the Cell Saver 5+ System

INTRODUCING THE CELL SAVER 5+ SYSTEM... 1-3 Indications for use... 1-3 Contraindications for use... 1-4 EXPLAINING AUTOLOGOUS BLOOD TRANSFUSION... 1-5 Autologous versus homologous transfusion... 1-5 Cell Saver systems and autologous transfusion... 1-5 Historical overview... 1-6 Haemonetics Cell Saver systems... 1-7 PRESENTING SPECIAL CELL SAVER 5+ FEATURES... 1-8 Automated operation... 1-8 Computer guided setup... 1-8 Final blood product quality... 1-9 Performance readouts... 1-9 Data acquisition tools... 1-9 Emergency mode... 1-9 LISTING THE CELL SAVER 5+ SPECIFICATIONS... 1-10 Fluid management systems... 1-11 Processing speeds... 1-11 Maneuverability and portability... 1-12 Construction... 1-12 ORDERING CELL SAVER 5+ DISPOSABLE SETS... 1-13 REFERENCES... 1-14

Chapter Two

Describing the Cell Saver 5+ System Components

PRESENTING THE CELL SAVER 5+ SYSTEM COMPONENTS... 2-3 Power switch and power entry module... 2-3 DESCRIBING THE CELL SAVER 5+ CONTROL PANEL... 2-4 Display screen... 2-4 Keypad... 2-5 DESCRIBING THE CELL SAVER 5+ HARDWARE ELEMENTS... 2-10 Valves... 2-10 Pump... 2-10 Air detector... 2-11 Clamped line sensor (blue line sensor)... 2-11

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Centrifuge well... 2-12 Fluid detectors... 2-12 Optical bowl sensor... 2-12 Effluent line sensor... 2-13 Waste bag weigher... 2-13 Reservoir level sensor... 2-13 PRESENTING THE DISPOSABLE SET ELEMENTS... 2-14 Harness tubing... 2-14 Receptacles and collection containers... 2-15 Centrifuge bowl... 2-16 Describing the operation of the bowl... 2-17

Chapter Three

Ensuring Safe Operation and Patient Care

UNDERSTANDING SAFE OPERATING PRACTICES... 3-2 Correctly storing and handling disposable material... 3-2 Avoiding electrical shock hazards... 3-2 Working with rotating machinery... 3-3 Power outlet connection... 3-3 Warning about communicable diseases... 3-3 PREVENTING PROBLEMS DURING A CELL SAVER 5+ PROCEDURE... 3-4 Avoiding the consequences of flow restriction... 3-4 Understanding the risk of hemolysis... 3-4 Inspecting for twists and kinks in the tubing... 3-5 Avoiding bowl misalignment... 3-5 Controlling for overheating... 3-5 Avoiding red blood cell spillage... 3-6 Managing the inventory of air... 3-6 PROVIDING SAFE PATIENT CARE... 3-7 Reinfusing blood... 3-7 Replacing depleted clotting factors... 3-7 Contraindications for use... 3-7 FACTORS AFFECTING PROCESSING TIME... 3-8 Cell Saving... 3-8 Sequestering... 3-8

Chapter Four

Preparing for a Cell Saver 5+ Procedure

UNDERSTANDING GENERAL SYSTEM OPERATION... 4-2 Collecting blood... 4-2 Filling the centrifuge bowl... 4-2 Separating and packing the cells in the bowl... 4-2 Washing the red blood cells... 4-3 Washing partial bowls... 4-3 Emptying the bowl... 4-3

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INITIATING A CELL SAVER 5+ PROCEDURE... 4-4 Explaining the power on procedure... 4-5 Explaining the bowl type confirmation message... 4-7 INSTALLING A CELL SAVER DISPOSABLE SET... 4-8 Preparing the collection system... 4-8 Preparing the device and disposable set... 4-9 Installing the bowl... 4-10 Installing the tubing harness... 4-11 Installing the line sensor tubing... 4-12 Hanging the bags... 4-13 Connecting the reservoir... 4-14 Setting up the saline solution... 4-15 Inspecting the installation... 4-15 Entering the STANDBY state... 4-16

Chapter Five

Cell Saving using Automatic Operation

PERFORMING A PROCEDURE IN THE AUTOMATIC MODE... 5-2 Explaining the STANDBY state... 5-2 Filling the bowl... 5-3 Washing the cells... 5-5 Emptying the bowl... 5-6 Monitoring the waste bag... 5-6 Reinfusing processed blood... 5-7 Explaining the air sensor detection messages... 5-8 Explaining the recentrifugation delay... 5-8 DESCRIBING ADDITIONAL AUTO MODE FUNCTIONS... 5-10 Using the EMERGENCY mode... 5-10 Explaining the CONCENTRATE state option... 5-11 Modifying certain processing parameters... 5-12 Automatic saving of modified parameters... 5-13 Pump RBCs to (RETURN) option... 5-14 Minimum Wash Volume option... 5-15 NO WASH option... 5-16 Reservoir Level and Resume at Level options... 5-17 Level Sensor option... 5-17 AutoCycle option... 5-17 Speed regulation option... 5-18 VIEWING THE CELL SAVER 5+ SYSTEM STATUS... 5-19 Wash volume monitoring... 5-20 Volume accounting function... 5-20 SUMMARIZING SETTING VARIATIONS... 5-22

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Chapter Six

Cell Saving using Manual Operation

PERFORMING A PROCEDURE IN THE MANUAL MODE... 6-2 Explaining the manual control keys... 6-3 Selecting manual operation... 6-4 Modifying preset processing parameters... 6-4 Explaining the recentrifugation delay... 6-5 Collecting fluid in the reservoir... 6-6 Filling the bowl... 6-6 Using the CONCENTRATE state... 6-7 Washing the cells... 6-7 Emptying the bowl... 6-8 Reentering the STANDBY state... 6-9 SUMMARIZING PARAMETER VARIATIONS... 6-10

Chapter Seven

Sequestering using the Cell Saver 5+ System

PRESENTING THE CELL SAVER 5+ SEQUESTERING PROTOCOL... 7-2 Describing method of sequestering... 7-2 INITIATING A SEQUESTERING PROCEDURE... 7-3 Selecting the sequestering protocol... 7-3 Setting the processing parameters... 7-5 PROCESSING FROM BLOOD BAGS... 7-6 Filling the bowl... 7-6 Emptying the bowl... 7-7 Transferring the RBCs for reinfusion... 7-8 COMPLETING THE SEQUESTERING PROCEDURE... 7-10 Removing the plasma product... 7-10 Removing the sequestering disposable set... 7-10 Selecting the cell saving protocol... 7-11

Chapter Eight

Using Data Acquisition Features

PROVIDING AN OVERVIEW OF THE FEATURES... 8-2 Listing the recorded parameters... 8-2 Explaining the output devices... 8-3 EXPLAINING ON-LINE DATA ACQUISITION FEATURES... 8-4 Viewing the current procedure data... 8-4 Transferring procedure data... 8-5 Optionally entering certain data... 8-6

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EXPLAINING OFF-LINE DATA ACQUISITION FEATURES... 8-7 Accessing off-line data acquisition... 8-7 Working with the Transfer Data function... 8-9 Working with the View Data function... 8-10 Working with the Set Time function... 8-11 Working with the Clear Data function... 8-12 LISTING DATA OUTPUT DEVICES... 8-13

Chapter Nine

Maintaining the Cell Saver 5+ Device

PROVIDING AN OVERVIEW OF NORMAL MAINTENANCE... 9-2 DESCRIBING SPECIFIC CLEANING PROCEDURES... 9-3 Cleaning the optical lenses... 9-3 Cleaning the centrifuge well... 9-3 Cleaning the fluid detectors... 9-3 Cleaning the blood pump... 9-3 Cleaning after a spill... 9-4 Washing the air filter... 9-4 PROVIDING CUSTOMER SERVICE... 9-5 Field service... 9-5 Installation and clinical training... 9-5 Returned goods authorization system... 9-5

Appendix A

Providing Reference Information

COMPLICATIONS OF AND CONTRAINDICATIONS TO PERIOPERATIVE BLOOD RECOVERY... A-2 DESCRIBING CELL SAVER 5+ ERROR CODES... A-7 PRESENTING THE CS5+ COMPATIBLE PRINTER... A-11 Non-thermal printer overview... A-11 Changing the paper roll during a printing procedure... A-11 Ribbon installation... A-12 Ordering references... A-12 EXPLAINING IEC 60601-1-2:2001 STANDARD REQUIREMENTS... A-13 Electromagnetic immunity... A-13

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Chapter One Presenting the Cell Saver 5+ System INTRODUCING THE CELL SAVER 5+ SYSTEM... 1-3 Indications for use... 1-3 Contraindications for use... 1-4 EXPLAINING AUTOLOGOUS BLOOD TRANSFUSION... 1-5 Autologous versus homologous transfusion... 1-5 Cell Saver systems and autologous transfusion... 1-5 Historical overview... 1-6 Haemonetics Cell Saver systems... 1-7 PRESENTING SPECIAL CELL SAVER 5+ FEATURES... 1-8 Automated operation... 1-8 Computer guided setup... 1-8 Final blood product quality... 1-9 Performance readouts... 1-9 Data acquisition tools... 1-9 Emergency mode... 1-9 LISTING THE CELL SAVER 5+ SPECIFICATIONS... 1-10 Fluid management systems... 1-11 Processing speeds... 1-11 Maneuverability and portability... 1-12 Construction... 1-12 ORDERING CELL SAVER 5+ DISPOSABLE SETS... 1-13 REFERENCES... 1-14

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Presenting the Cell Saver 5+ System

Figure 1-1, The Haemonetics Cell Saver 5+

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Presenting the Cell Saver 5+ System

INTRODUCING THE CELL SAVER 5+ SYSTEM The Haemonetics Cell Saver 5+ Autologous Blood Recovery System (CS5+) represents the fifth generation since the introduction of the first successful autologous blood collection system, the original Cell Saver 1 System. Using the latest microprocessor technology, the Cell Saver 5+ system delivers a high level of automation in the processing of autologous blood. Operator interaction and surveillance are minimized by the use of a sensor which automatically detects the level of fluid in the reservoir and initiates device operation. Processing time has also been reduced while maintaining the highest quality end product. The Haemonetics Cell Saver 5+ system and its related accessory devices are intended to be used for the recovery of blood shed during or after an operation, or as the result of trauma. The shed blood is collected in a sterile reservoir, then processed by the Cell Saver system in a centrifuge bowl to pack red blood cells (RBCs), then washed to remove cell stroma, platelets, activated clotting factors, extracellular potassium, free hemoglobin, anticoagulant, and cardioplegia. The washed, packed RBCs may then be pumped to a bag for gravity reinfusion to the patient, or, to the arterial line of an extracorporeal circuit for reinfusion to the patient

Indications for use The CS5+ system should be considered for a procedure when it is anticipated that blood will be shed from a clean wound and retrieved at a rate permitting aspiration without undue hemolysis. The presence of any of the following criteria may be an indication for blood salvage: !

Anticipated blood loss is 15% or more of the patient’s estimated blood volume.

!

Blood would ordinarily be crossmatched.

!

More than 10% of the patients undergoing the type of procedure require transfusion.

!

The mean transfusion rate for the type procedure exceeds one unit.

Specific types of surgery for which the technique is especially useful include: !

Open heart and vascular surgery.

!

Total joint replacements and spinal surgery.

!

Liver transplantation.

!

Ruptured ectopic pregnancy.

!

Selected neurosurgical procedures.

Post-operative salvage is employed most often following cardiac and certain types of orthopedic procedures 1.

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Presenting the Cell Saver 5+ System

A disposable bowl called the 70mL Bowl has been designed specifically for low volume peri-operative cell salvage. This new step in cell saving is very well adapted for every type of low volume blood loss situation, including peri-operative pediatric cell salvage and post-operative orthopedic cell salvage. Use of this bowl will allow blood to be available earlier for reinfusion to the patient. The Haemonetics Cell Saver 5+ system may also be used for pre-operative plasma sequestration.

Contraindications for use The risk/benefit ratio of blood salvage must be determined on an individual basis by the surgeons, anaesthetists and transfusion medicine specialists involved in the patient care. The Appendix A provides a list of recommended contraindications.

Warning: The use of reinfused blood from the Cell Saver 5+ 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.

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Presenting the Cell Saver 5+ System

EXPLAINING AUTOLOGOUS BLOOD TRANSFUSION Autologous blood is now widely accepted as the first choice for transfusion, whenever possible. The term autologous blood refers to blood which is derived from one individual. An autologous blood transfusion can be defined as a procedure in which a patient receives his or her own blood. The blood may have been collected earlier or salvaged from shed blood intraoperatively or postoperatively. Homologous blood is blood of the same type, donated or derived from sources other than the patient who is receiving the transfusion.

Autologous versus homologous transfusion The advantages of autologous transfusion are well documented. The major advantages are as follows: !

No risk of disease transmission.

!

No transfusion reactions.

!

Requires minimal compatibility testing.

!

Reduces demand on blood bank inventory.

Cell Saver systems and autologous transfusion In addition to the general benefits of autologous transfusion, the Cell Saver systems provide the following benefits: !

Portability.

!

Rapid setup.

!

Rapid return of patient’s own cells.

!

Reduction of net blood loss.

!

Removal of red cell stroma.

!

Removal of plasma-free hemoglobin.

!

Removal of anticoagulant solution.

!

Removal of activated clotting factors.

!

Removal of extracellular potassium.

!

Cost-effectiveness.

!

General acceptance by Jehovah’s witnesses.

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Presenting the Cell Saver 5+ System

Historical overview The following paragraphs summarize the history of transfusion methods. Early experiments with transfusion Some of the earliest recorded attempts at transfusion were undertaken by a French physician, Jean Denys, who in the 1660’s performed transfusions between animals and humans with predictably disastrous results 2. Quite reasonably, the French government stepped in and forbade the transfusion of blood except with the permission of a member of the Faculty of Medicine of Paris (which was strongly opposed to the practice). Rumors of Denys’ experiments and his results were circulated throughout Europe, and fear of such practices spread to other countries. In 1818 an English surgeon, James Blundell, reported on a human-to-human transfusion which he had performed (though unsuccessfully). Blundell later did perform successful transfusions, and his are the first recorded successes 3. More importantly, Blundell’s attempts were relatively scientific and he recorded a great deal of useful information on transfusion. He also noted that the donation of a small quantity of blood produced no harmful effects on the donor 4. First recorded uses of autologous transfusion In the late 1800’s, an English surgeon named James Highmore proposed the use of autotransfusion (another term used for autologous transfusion) and suggested that a patient’s own shed blood was an overlooked source which could be used to great advantage. His article which appeared in The Lancet in 1874, advocated intra-operative autotransfusion, specifically in the case of post-partum hemorrhage 5. Highmore later recorded his successful use of autotransfusion in a variety of cases 6. The use and acceptance of homologous blood In the early 1900’s, techniques for typing and matching blood were developed. Homologous transfusions gradually became accepted, though the general method remained the transfusion of blood directly from donor to recipient, rather than the use banked blood. The first blood bank was established at Cook County Hospital, Chicago on March 15, 1937. However, the real rise of homologous transfusions came during World War II 7. There was a great need for blood during the war, as would be expected, and the donor pool in the United States grew enormously to meet this need. Using banked blood was quite simply the easiest alternative and homologous transfusions became the norm.

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Presenting the Cell Saver 5+ System

Naturally, doctors returning from the war continued to rely on donor blood, although several factors were developing which would make this less and less practical. The Korean and Vietnam wars which followed World War II placed the usual high demands on the donor pool. Concurrently, other large demands were being placed on the donor pools by the development and refinement of sophisticated surgical procedures such as open heart surgery. The shortages of donor blood during the Vietnam War revived interest in autotransfusion. In Vietnam, an American military surgeon named Klebanoff began using the open heart pump to capture, anticoagulate, filter, and reinfuse the blood lost in surgery 8. Klebanoff’s device was introduced commercially in the 1970’s by Bentley Laboratories. The device was effective though unsophisticated, as blood was simply anticoagulated, filtered, and reinfused. The Bentley device was the first attempt to modernize autologous blood recovery in decades.

Haemonetics Cell Saver systems Haemonetics Cell Saver systems are aptly named since the primary purpose is the recovery of red blood cells (RBCs). The RBCs are recovered shed blood which in the past was simply discarded after an operation. Cell Saver systems trap and wash the RBCs, removing unwanted components, then pack the RBCs and return them to a transfer container for reinfusion. The first Haemonetics Cell Saver system was released in 1975. With each generation of the Cell Saver systems, Haemonetics has improved performance and increased automation. Haemonetics offers a variety of Cell Saver systems to be used for a wide range of surgical procedures.

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