Cell Saver 5 Operation Manual Rev A June 2001

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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.

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. ii

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Preface

Inquiry addresses Please direct any written inquiries to the appropriate address. Haemonetics Corporation - Headquarters 400 Wood Road Braintree, MA 02184, USA Tel. [1-781] 848 7100 Fax [1-781] 848 5106 Haemonetics SA International - Headquarters Signy Centre, 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 !

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.

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.

Symbols found on the device The descriptions of the following symbols are based on information provided in the following documents: !

In compliance with IEC 601-1:88 and IEC 601-1-2:93.

!

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

!

IEC Standard 60417-1, Graphical symbols for use on equipment, Part 1: Overview and application.

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Preface

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.

~

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 outlet). Power ON Position of the main power switch indicating connection to the mains (power outlet). 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).

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

REF

CATALOG NUMBER

EXPIRATION DATE

LOT

Lot Number

Sterilized by exposure to Ethylene Oxide

Fluid path STERILE by exposure to Ethylene Oxide

Sterilized by exposure to Gamma irradiation

Fluid path STERILE by exposure to Gamma irradiation

DO NOT REUSE

Caution: consult operator manual for instructions

Storage conditions, humidity level

Storage conditions, temperature level

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Haemonetics worldwide Haemonetics Asia Inc. Taiwan Branch, 26-1 Floor 102 Roosevelt Road / Section 2 Taipei / Taiwan Tel. [886-2] 2369 072 Fax [886-2] 2364 3698

Haemonetics CZ, spol. S.r.o Ptašínského C.8 60200 Brno, Czech Republic Tel. [42-05] 412122400 Fax [42-05] 412122399

Haemonetics Austria HGmbH Berlagasse 45/B2-02 1210 Wien, Austria Tel. [43-1] 294 29 00 Fax [43-1] 294 29 05

Haemonetics Hong Kong Suite 1314, 13/F Two Pacific Place 88 Queensway, Hong Kong Tel. [852] 2868 9218 Fax [852] 2801 4380

Haemonetics S.A. / N.V. - Belgium Leuvensesteenweg 542-B. 14 Planet II Complex 1930 Zaventem, Belgium Tel. [32] 2 - 720 74 84 Fax [32] 2 - 720 71 55

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 B.V. - Netherlands C/O CITCO - WTC, PB 7241 Strawinskylaan 1725 1007 JE AMSTERDAM The Netherlands Tel. [31-35] 6023 425 Fax [31-35] 6024 198

Haemonetics GmbH Rohrauerstrasse 72 81477 Münich, Germany Tel. [49-89] 785 80 70 Fax [49-89] 780 97 79

Haemonetics China Shanghai Representative Office Room 28032, 28/F Shanghai Senmao Int. Building 101 Yin Cheng East Road, Pudong New Area, Shanghai 200120, China Tel. [86] 21 50 66 33 66 Fax [86] 21 68 41 36 88

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Haemonetics Italia Srl Via Donizetti 30 20020 Lainate (MI), Italia Tel. [39-2] 935 701 13 Fax [39-2] 935 721 32

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Preface Haemonetics Japan Co. Ltd Kyodo Building 3F 16, Ichiban-cho, Chiyoda-ku Tokyo, Japan, 102-0082 Tel. [81-3] 3237 7260 Fax [81-3] 3237 7330 Haemonetics Scandinavia AB IDEON Scheelegatan 17 S - 223 70 Lund, Sweden Tel. [46] 46 286 23 20 Fax [46] 46 286 23 21

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Haemonetics Switzerland SA Signy Centre, P.O. Box 262 1274 Signy 2, Switzerland Tel. [41-22] 363 90 11 Fax [41-22] 363 90 54 Haemonetics (UK) Ltd. Beechwood House Beechwoods Estate Elmete Lane, Roundhay Leeds LS8 2LQ, UK Tel. [44-1132] 273 7711 Fax [44-1132] 273 4055

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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... 1-13 ORDERING CELL SAVER 5 DISPOSABLE SETS... 1-14 References... 1-15

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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...2-11 Air detector...2-11 Clamped line sensor (blue line sensor)...2-11 Centrifuge well...2-12 Fluid detectors...2-12 Optical bowl sensor...2-13 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...2-18

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 Warning about communicable diseases...3-3 PREVENTING PROBLEMS DURING A CELL SAVER 5 PROCEDURE3-4 Avoiding the consequences of flow restriction...3-4 Inspecting for twists and kinks in the tubing...3-4 Understanding the risk of hemolysis...3-4 Controlling for overheating...3-5 Avoiding red blood cell spillage...3-5 x

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Table of contents 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... 4-3 Washing the red blood cells... 4-3 Emptying the bowl... 4-3 INITIATING A CELL SAVER 5 PROCEDURE... 4-4 Explaining the power-on procedure... 4-4 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... 4-14 Connecting the reservoir... 4-15 Setting up the saline solution... 4-15 Inspecting the installation... 4-15 Entering the STANDBY state... 4-16

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Chapter Five

Cell Saving using Automatic Operation

PERFORMING A PROCEDURE IN THE AUTOMATIC MODE .5-2 Explaining the STANDBY state...5-3 Filling the bowl...5-4 Washing the cells...5-6 Emptying the bowl...5-7 Monitoring the waste bag...5-7 Reinfusing processed blood...5-8 Explaining the air sensor detection messages...5-9 Explaining the recentrifugation delay...5-10 DESCRIBING ADDITIONAL AUTO MODE FUNCTIONS...5-11 Using the EMERGENCY mode...5-11 Explaining the CONCENTRATE state option...5-12 Modifying certain processing parameters...5-14 Automatic saving of modified parameters...5-15 Pump RBCs to (RETURN) option...5-16 Minimum Wash Volume option...5-18 NO WASH option...5-18 Reservoir Level and Resume at Level options . . .5-19 Level Sensor option...5-19 Speed regulation option...5-20 VIEWING THE CELL SAVER 5 SYSTEM STATUS...5-21 Wash volume monitoring...5-22 Volume accounting function...5-22 SUMMARIZING SETTING VARIATIONS...5-24

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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... 6-5 Explaining the recentrifugation delay... 6-6 Collecting fluid in the reservoir... 6-6 Filling the bowl... 6-7 Using the CONCENTRATE state... 6-7 Washing the cells... 6-8 Emptying the bowl... 6-9 Reinfusing processed blood... 6-10 Reentering the STANDBY state... 6-11 SUMMARIZING PARAMETER VARIATIONS... 6-12

Chapter Seven

Sequestering using the Cell Saver 5 System

PRESENTING THE CELL SAVER 5 SEQUESTERING PROTOCOL 7-2 Describing methods of sequestering... 7-2 INITIATING A SEQUESTERING PROCEDURE... 7-3 Selecting the sequestering protocol... 7-3 Setting the processing parameters... 7-5 Warning about direct patient connection... 7-6 USING THE DIRECT DRAW METHOD... 7-7 Filling the bowl... 7-7 Emptying the bowl... 7-8 Transferring the RBCs for reinfusion... 7-10 PROCESSING FROM BLOOD BAGS... 7-11 Filling the bowl... 7-11 Emptying the bowl... 7-12 Transferring the RBCs for reinfusion... 7-14 COMPLETING THE SEQUESTERING PROCEDURE... 7-15 Removing the plasma product... 7-15 Removing the sequestering disposable set... 7-16 Selecting the cell saving protocol... 7-16

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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...8-6 Optionally entering certain data...8-6 EXPLAINING OFF-LINE DATA ACQUISITION FEATURES...8-8 Accessing off-line data acquisition...8-8 Working with the Transfer Data function...8-10 Working with the View Data function...8-12 Working with the Set Time function...8-13 Working with the Clear Data function...8-14 LISTING DATA OUTPUT DEVICES...8-16

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...9-4 Cleaning after a spill...9-4 Washing the air filter...9-5 PROVIDING CUSTOMER SERVICE...9-6 Field service...9-6 Installation and clinical training...9-6 Returned goods authorization system...9-6

Appendix

Providing Reference Information

LISTING INTRAOPERATIVE SUBSTANCES AND EFFECTS... A-2 DESCRIBING CELL SAVER 5 ERROR CODES... A-4

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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... 1-13 ORDERING CELL SAVER 5 DISPOSABLE SETS... 1-14 References... 1-15

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Presenting the Cell Saver 5 System

Figure 1-1, The Haemonetics Cell Saver 5 1-2

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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 (CS 5) 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 CS 5 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.

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Presenting the Cell Saver 5 System 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. A disposable bowl called the Bowl 70 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’s care. The Appendix provides a chart of intraoperative substances, effects and recommended actions. 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 intra-operatively 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.

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