OrthoPAT Operation Manual Rev B March 2004

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Consumer information Proprietary rights The contents of this manual are property of the Haemonetics Corporation. Haemonetics®, OrthoPAT® and Dynamic Disk™ are registered trademarks 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. 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 Legal disclaimer 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, or its authorized distributor.

P/N 85252-30, Manual revision B

OrthoPAT - Preface

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 OrthoPAT perioperative autotransfusion system 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 bloodcontaminated material. The operator of any Haemonetics equipment must understand and implement the local policies and standard operating procedures concerning the handling of 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.

OrthoPAT - Preface

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Symbols found in this document

Haemonetics worldwide

The terms Note, Caution and Warning are used in this manual with the following symbols to emphasize certain details for the operator.

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

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 patient 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.

Haemonetics GesmbH 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 Naritaweg 165 1043 BW Amsterdam Netherlands Tel. [+31 35] 602 3425 Fax [+31 35] 602 4198 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 Haemonetics CZ, spol. s r.o. Ptašínského C.8 60200 Brno, Czech Republic Tel. [+42 05] 4121 2400 Fax [+42 05] 4121 2399

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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 Haemonetics Scandinavia AB Beta Huset, Ideon Scheelegatan 17 223 70 Lund, Sweden Tel. [+46 46] 286 2320 Fax [+46 46] 286 2321

P/N 85252-30, Manual revision B

OrthoPAT - Preface

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

Table of contents

Section 1 Introduction Background...1-2 System description ...1-2 Principles of operation...1-3 Benefits ...1-4 Patient benefits...1-4 Operator benefits ...1-4 Cost effectiveness ...1-4 Section 2 Clinical Use Indications for use ...2-2 Contraindications ...2-2 Patient safety warnings...2-3 Operator safety warnings...2-3 Potential adverse effects ...2-3 Recommendations ...2-3 References ...2-4 Section 3 System Description Equipment ...3-2 Base unit...3-2 Base internal components ...3-7 Display unit ...3-7 Disposable set ... 3-10 Intra-op suction set ... 3-10 Post-op suction set ... 3-11 Processing set ... 3-12 Replacement RBC bags... 3-15 Replacement waste bags ... 3-15 Additional intraoperative suction sets... 3-15 Additional postoperative suction sets ... 3-15

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OrthoPAT - Table of contents

Section 4 System Operation Mounting the system on an IV pole...4-2 Loading the disposable set ...4-3 System initialization...4-6 Intraoperative operation mode ...4-7 Starting Intra-op RUN mode ...4-7 Intra-op volume accounting (EBL) ...4-8 Intra-op processing cycle ...4-9 Transitions out of Intra-op RUN mode... 4-10 Postoperative operation mode ... 4-11 Starting Post-op RUN mode ... 4-11 Post-op volume accounting (EBL)... 4-12 Post-op processing cycle ... 4-13 Transitions out of Post-op RUN mode... 4-14 STANDBY mode ... 4-14 Transitions out of STANDBY mode... 4-14 Process function ... 4-15 Process Until Empty function ... 4-15 Suction function ... 4-16 Alarm mute ... 4-16 Battery power operation... 4-16 Removing the disposable set... 4-17 Estimated Blood Loss volume accounting sheet... 4-18 In INTRA-OP mode ... 4-18 In POST-OP mode ... 4-18 Section 5 Clinical Operation Transition from INTRA-OP to POST-OP ...5-2 Transfusing recovered RBCs...5-2 Replacing RBC bags ...5-3 Replacing the waste bag ...5-3 Replacing the saline bag ...5-4 Spare suction lines ...5-4 Patients returning to surgery ...5-4 Section 6 Troubleshooting Introduction...6-2 Event notifications and error messages ...6-2 Component failures ...6-2 General operation ...6-2 Disposable loading ... 6-10 Intraoperative operation ... 6-12 Postoperative operation... 6-13

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OrthoPAT - Table of contents

vii

Battery power... 6-14 Power interrupt recovery ... 6-15 Opening cover after power interrupt ... 6-15 Capacity overflow... 6-15 Blood transfer after a blood spill ... 6-15 Postoperative blood transfer... 6-16 Intraoperative blood transfer ... 6-19 Replacing the spill collection bag... 6-22 Section 7 Facilities, Maintenance and Storage Facilities ...7-2 Storage ...7-2 Quality assurance ...7-2 Operator care ...7-2 Servicing ...7-2 Functionality...7-3 Preventative maintenance ...7-3 Cleaning the device after a blood spill...7-4 Cleaning the centrifuge ...7-4 Cleaning the RBC detector...7-5 Cleaning the optics window...7-5 Customer Service...7-5 Clinical training...7-5 Field service...7-5 Returned goods authorization system (RGA)...7-5 Appendix A System Specifications Specifications...A-2 Dimensions and weight ... A-2 Power supply ... A-2 Other characteristics ... A-2 Symbols found on the device ...A-3 Symbols found on disposable packaging ...A-3 Appendix B The Dynamic Disk Disk components... B-2 How the separation chamber works ... B-2 How the disk works ... B-3

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Section 1

Introduction Background...1-2 System description ...1-2 Principles of operation...1-3 Benefits ...1-4 Patient benefits...1-4 Operator benefits ...1-4 Cost effectiveness ...1-4

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1-2

Background Autotransfusion is a technique of salvaging and reinfusing red blood cells (RBCs) from blood shed by a patient due to surgery or trauma. Reinfusing the salvaged RBCs reduces the patient’s need for allogeneic blood transfusion. The technique was first developed for use in cardiovascular surgery but is used increasingly in orthopedic procedures as well. Autotransfusion devices separate the intact RBCs from the undesirable components in the fluid portion of the shed blood and the surgical irrigating solutions. The separated RBCs are then available for reinfusion to the patient. Autotransfusion devices use either centrifugation or filtration to separate the RBCs. Many autotransfusion devices salvage RBCs from blood shed in the surgical field. Intraoperative autotransfusion has become standard medical practice in many cardiovascular, trauma and transplant procedures. During intraoperative autotransfusion, blood is suctioned from the surgical site, anticoagulated and collected into a reservoir. When there is a sufficient quantity of shed blood in the reservoir, it is processed through a separation chamber to concentrate the RBCs and remove the supernatant fluid. Some systems will then further purify the RBCs by washing them with saline. Systems have also been developed to salvage RBCs from blood shed from the surgical wound site after surgery. In most surgical procedures the surgeon places wound drain tubing into the wound to allow fluid to drain out of the body. Wound drains are designed to prevent postoperative fluid build-up which may delay healing, increase

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OrthoPAT - Introduction

pain and increase the chance of infection. Postoperative autotransfusion is the collection and reinfusion of the blood lost through the wound drain. Most postoperative autotransfusion systems do not separate and wash the RBCs, but merely filter the wound drainage to remove any large blood clots. The OrthoPAT perioperative autotransfusion system represents a new approach to autotransfusion. It is designed specifically for use in orthopedic procedures of significant blood loss such as joint replacement and spinal fusion. The same disposable set is used intraoperatively and postoperatively to provide perioperative autotransfusion, salvaging RBCs whenever and wherever blood is lost, both during and after surgery. RBCs are separated from waste products by centrifugation during both intraoperative and postoperative processing. They are then washed and reconcentrated for greater purity. The OrthoPAT system represents the first comprehensive approach to orthopedic autotransfusion.

System description The OrthoPAT system is designed to provide perioperative autotransfusion for patients undergoing orthopedic surgery. The system consists of single-patient use disposable sets and an electromechanical device which together collect and process the RBCs lost during and after surgery. The small and highly portable system mounts onto an IV pole and is designed to be used both in the operating room to recycle blood lost during surgery, and in the recovery room, to recycle blood lost after surgery.

OrthoPAT - Introduction

It can then be transported with the patient to the floor to continue postoperative salvage. The disposable set is the only part of the system that comes in contact with the patient’s blood. It has a sterile fluid pathway for use by a single patient both during and after a single surgical procedure. The heart of the system is a centrifuge disk in which the red cells are separated from supernatant and washed. The OrthoPAT disk is distinctive in that it dynamically changes size while it is spinning and provides a consistent hematocrit product regardless of the volume or hematocrit of blood processed. The disposable set also includes a reservoir to hold the blood and fluid aspirated from the surgical field or suctioned from the wound drain prior to processing. It also includes a bag for holding the processed RBCs and a waste bag. Tubing and valve systems interface with the electromechanical device to control the flow of fluid between the reservoir, disk and bags. The electromechanical device consists of a centrifuge, pneumatic system, valve controllers, sensors and computer which control the processing and monitor the operation of the system. A display unit shows the operator the volume of fluid that has been collected and allows the operator to switch the system between intraoperative and postoperative operation. It also informs the operator should an error occur during operation. The system operates automatically with little operator intervention beyond loading the disposable set.

1-3

Principles of operation Blood shed from either the surgical site or the wound drain is suctioned into the reservoir of the system. The reservoir contains a large mesh filter that retains any bone fragments, blood clots, or other large debris that may be found in shed blood. The shed blood and aspirated fluid are stored in the reservoir until there is sufficient volume, after which the OrthoPAT system initiates processing. The OrthoPAT system continues automatically to process blood as long as there is sufficient fluid in the reservoir. During automatic processing, blood is pulled into the disk in 100 ml batches. The system can be manually overridden to process less than 100 ml when necessary. In the disk, centrifugal force is used to separate intact red blood cells from the cell fragments, irrigation fluid, plasma, and other undesirable components that are found in the fluid portion of the shed blood. The RBCs travel to the outside edge of the spinning disk. The disk is then compressed to push the undesirable supernatant out and into the waste bag. After the waste supernatant has been removed, the red blood cells are then washed with saline to further purify the RBCs and remove undesirable components. The dynamic disk’s ability to obtain a very high concentration of the RBCs prior to the rinse step results in an extremely efficient washout of undesirable components.

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1-4

OrthoPAT - Introduction

Benefits

Cost effectiveness

The OrthoPAT system offers benefits to the patient, the operator and the medical institution.

A single disposable processing set for RBC salvage used both during and after surgery is less costly than using separate disposable processing sets for intraoperative and postoperative salvage.

Patient benefits By salvaging intact RBCs from perioperative blood, the OrthoPAT system potentially reduces the patient’s need for allogeneic blood transfusion, thereby reducing the risk of allogeneic transfusion reaction and transmission of infectious disease. The OrthoPAT system may potentially reduce the number of predonated autologous units required to completely support a patient’s surgical need. The OrthoPAT system provides a consistently high hematocrit RBC product. The amount of excess fluid and contaminants that the patient might receive from other autotransfusion techniques is reduced. Internal vacuum control and battery backup assure consistent, uninterrupted suction on the wound drain site, even during patient transport. Operator benefits The disposable set loads easily into the OrthoPAT system. The OrthoPAT system is fully automated and requires little operator interaction with the system beyond loading the disposable. Continuous display of the volume of fluid collected from either the surgical site or the wound drain simplifies charting of the patient’s fluid balance. The small portable system is easy to transport, clean and store.

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Salvaging RBCs whenever the blood is lost makes autotransfusion cost effective for patients for whom the volume of intraoperative or postoperative blood loss alone could not justify the cost of autotransfusion. Since the fully automated OrthoPAT system does not require a dedicated operator to monitor its operation, there is no additional labor cost for providing perioperative autotransfusion to the patient.

Section 2

Clinical Use Indications for use ...2-2 Contraindications ...2-2 Patient safety warnings...2-3 Operator safety warnings...2-3 Potential adverse effects ...2-3 Recommendations ...2-3 References ...2-4

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OrthoPAT - Clinical Use

The decision to use autotransfusion and reinfuse salvaged RBCs is entirely within the domain of the responsible medical team. The following recommendations are based upon generally accepted medical practice regarding autotransfusion.

Contraindications Autotransfusion is generally contraindicated in the following circumstances: !

In the presence of systemic infection.

!

Blood salvaged from the surgical field contaminated by bacteria from an active infection at wound or drain site.

!

Malignant cells mixed with the blood salvaged from the surgical field.

!

Salvaged red blood cells contain sickle cell hemoglobin.

!

Prostatic fluid or amniotic fluid mixed with the blood salvaged from the surgical field.

!

The collected blood contains certain topical hemostatic agents, anti-bacterial agents or wound irrigants not intended for parenteral use, that may damage RBCs or are inappropriate for infusion.

!

During cement application: Methylmethacrylate or other cements may cause hemolyses of RBCs.

Indications for use The OrthoPAT orthopedic perioperative autotransfusion system is indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to 2 liters per hour. Autotransfusion is indicated for patients who meet at least one of the following criteria: !

!

The patient is expected to lose sufficient blood in the perioperative period so as to require RBC transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion. Religious beliefs cause the patient to refuse allogeneic transfusion, but accept autologous transfusion.

!

Compatible allogeneic blood is not available.

!

The patient is unable to donate sufficient quantities of autologous blood prior to surgery to adequately cover the anticipated transfusion requirement.

!

The patient or physician prefers perioperative autotransfusion rather than preoperative autologous donation or transfusion of allogeneic blood.

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The OrthoPAT system is designed for blood loss rates commonly seen in elective orthopedic surgery. The OrthoPAT processes up to 2 liters of fluid per hour. It is not appropriate for procedures involving high, rapid blood loss such as liver transplants or certain cardiovascular procedures. Some trauma procedures may also be contraindicated, particularly where blood loss is high and it is necessary to return processed RBCs rapidly, or where there is a possibility of contamination from an open wound.

OrthoPAT - Clinical Use

Patient safety warnings

2-3

Potential adverse effects

"

Do not suspend the OrthoPAT system above the patient on an orthopedic cage or bed-mounted IV pole. A falling instrument could cause serious injury.

Although autotransfusion is a well accepted medical practice there are some potential adverse effects associated with the procedure. These include:

"

Clearly label the RBC bag for AUTOLOGOUS USE ONLY and with the patient name, ID and collection start time. Match the patient name and ID to the label on the unit prior to reinfusing.

!

Pressurized reinfusion of salvaged RBCs may cause air embolism by forcing any air in the RBC bag into the patient's circulation.

!

Infusion of the RBCs without a filter could introduce micro-emboli into the patient’s circulation.

!

The materials in the disposable set or the anticoagulants or rinse solutions used in autotransfusion may, in rare cases, cause an allergic reaction in the patient.

!

Large quantities (several units of blood) of salvaged RBC transfusion have been reported to cause coagulation abnormalities.

"

Disconnect the RBC bag from the system prior to reinfusing the RBCs.

Any recovered blood product may contain microemboli. Always reinfuse salvaged RBCs through a standard transfusion filter. Warning: The RBC bag contains a small amount of air. DO NOT PRESSURE REINFUSE. The disposable set is for singlepatient use only.

Operator safety warnings "

Follow local standard operating procedure blood precautions when using the OrthoPAT system, particularly when changing the RBC bag, changing the waste bag or cleaning a blood spill.

"

Do not use the OrthoPAT system in the presence of flammable anesthetics.

"

Do not touch rotating parts or open the instrument to expose the electronics.

"

Attach the OrthoPAT system only to appropriately grounded electrical outlets.

Recommendations The following recommendations may improve the performance of the OrthoPAT system: "

Maintain suction levels as low as possible to reduce RBC damage as the shed blood travels through the suction tip to the reservoir. Note: The recommended intraoperative suction setting is –150 mm Hg (–20 kPa; –200 mbar) or less. Higher suction levels increase the amount of RBC hemolysis.

The OrthoPAT system is designed for use only with compatible OrthoPAT disposable sets.

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2-4

"

"

"

"

OrthoPAT - Clinical Use

Avoid suctioning bone chips and bone cement into the reservoir, as they may lyse cells, occlude the suction lines or clog the filter. Avoid suctioning water and non-isotonic solutions into the reservoir as this will lyse the collected RBCs. Avoid suctioning calcium-containing solutions into the reservoir as this may activate platelets. Suction large volumes of irrigation solutions into a separate waste reservoir. Note: Concentrating large volumes of low hematocrit fluid from the surgical site increases the procedure time with a very low yield of RBCs.

"

Assure adequate anticoagulation. Note: Excess anticoagulant is washed out by the system.

"

Do not suction blood into the OrthoPAT system during cement application. Resume salvage once the wound site has been irrigated.

It remains the responsibility of the surgeon to determine how frequently to reinfuse recovered processed blood or, if during a prolonged surgery, the risk of sepsis warrants discontinuation of intraoperative recovery or changing the intraoperative salvage devices’ disposable. For more detailed recommendations please consult local standard operating procedure.

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References Lake CL, Moore RA, eds. Blood hemostasis, transfusion, and alternatives in the perioperative period. New York: Raven Press, 1995. Petz LD, Swisher SN, Kleinman S, Spence RK, Strauss RG, eds. Clinical practice of transfusion medicine. Third Edition. New York: Churchill Livingstone, 1996. Salem MR. Blood conservation in the surgical patient. Baltimore, MD: Williams & Wilkins, 1996. Guidelines for blood salvage and reinfusion in surgery and trauma. Bethesda, MD: American Association of Blood Banks, 1997. Perioperative autologous transfusion. Arlington, VA, Transcribed Proceedings of a National Conference, American Association of Blood Banks, 1991.

Section 3

System Description Equipment ...3-2 Base unit...3-2 Base internal components ...3-7 Display unit ...3-7 Disposable set ... 3-10 Intra-op suction set ... 3-10 Post-op suction set ... 3-11 Processing set ... 3-12 Replacement RBC bags... 3-15 Replacement waste bags ... 3-15 Additional intraoperative suction sets... 3-15 Additional postoperative suction sets ... 3-15

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3-2

OrthoPAT - System Description

Equipment

Base unit

The OrthoPAT equipment is designed to be mounted onto the IV pole. It consists of two units, which are connected by a permanently attached cord: !

The base unit.

!

The display unit.

Figure 3-1 shows the base unit including the deck, front and left side of the equipment. The components are described below. Centrifuge The OrthoPAT centrifuge performs two functions.

Both units are designed to prevent fluid from reaching the internal electrical components. Electrical and dimensional specifications are detailed in Appendix A. 1. 2. 3. 4. 5. 14. 13.

6. 7. 8.

12. 11. 10.

9.

Figure 3-1: Base unit (front view) 1. Cover handle 2. Cover 3. Header arm 4. RBC sensor 5. Centrifuge 6. Centrifuge spill container ring 7. Effluent valve housing (outlet valve) 8. Cover lock 9. RBC bag pins 10. Reservoir brackets 11. Reservoir sensor 12. Reservoir level detector window 13. Reservoir vacuum port 14. Inlet valve housing

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!

It spins the dynamic disk to separate the RBCs from the waste product.

!

It also controls the volume of the separation chamber by applying either vacuum or air pressure to the outside of the disk diaphragm.

See Appendix B for details on the operation of the dynamic disk. Air enters or leaves the centrifuge chuck through a port below the centrally located air diffuser. The air diffuser forces the air to enter or leave from the bottom center of the centrifuge chuck and protects the internal pneumatic system in case of a blood spill. A series of internal pneumatic valves and sensors control the air flow in the centrifuge. When the disk is properly seated, the centrifuge pneumatic system can maintain a vacuum indefinitely and can generate up to 3 psi (approximately 21 kPa; 207 mbar) of pressure in the centrifuge chuck. When the disk is seated in the centrifuge, the D-ring seals it to the centrifuge chuck. The disk is further held in place by the retainer ring. Air pressure or vacuum generated by the pneumatic system deflects the diaphragm to change the disk volume and to control the size of the separation chamber.

OrthoPAT - System Description

3-3

The centrifuge chuck allows the disk to expand to a maximum capacity of approximately 100 ml. Figure 3-2 shows a detail of the centrifuge, and disk/centrifuge interface.

A. B. C. 1.

2.

3. 4.

Figure 3-2: Centrifuge and disk interface A. Centrifuge chuck B. Rotating disk components C. Stationary disk components 1. 2. 3. 4.

Diaphragm Hollow centrifuge motor shaft D-ring Retainer ring

The centrifuge speed range is from 0 to 5500 rpm. The centrifuge speed is controlled and monitored by the system controller, and varies during the processing cycle. The centrifuge motor and drive interface are sized such that there is not sufficient power in the system to spin the centrifuge at a dangerously high speed. Diffuser cap (not shown in Figure 3-1) The diffuser cap forms the airflow pathway used to move the diaphragm of the dynamic disk during the fill or empty phases of the processing cycle. It is a white cap that makes up the center portion of the centrifuge chuck.

The diffuser cap captures a hydrophobic filter and gasket that prevent fluid from reaching the internal pneumatics in the event of a blood spill. The cap is screwed down into place and should be finger tight at all times. For removal and/or replacement of these parts refer to Section 7 of this manual. Centrifuge spill containment ring In the event of a fluid spill in the centrifuge, the centrifuge spill containment ring contains the blood in the centrifuge area. The ring can be removed easily to clean the centrifuge. See Section 7 for cleaning instructions. Cover The cover is translucent to allow the operator to observe the blood processing. It prevents debris or spilled fluids from falling into the spinning disk and protects the operator from accidental contact with rotating parts. Its primary function is to prevent any blood or parts of the disk from exiting the centrifuge if a disk should fail during operation. There are notches in the cover to accommodate the tubing that connects the components underneath to the bags and reservoir located outside the cover. Cover lock The cover lock ensures operator safety by keeping the cover closed whenever the centrifuge is spinning. A sensor incorporated into the cover lock verifies the cover lock status to the controller. When the system is powered off while the disk is spinning, the cover will remain locked until the disk has come to a complete stop. A manual override allows the cover lock to be released. See Section 6 for details.

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3-4

OrthoPAT - System Description

Effluent valve (outlet valve)

RBC sensor

The effluent valve controls the three-port effluent stopcock (outlet stopcock) which is a component of the disposable set. The valve turns the stopcock to divert fluid exiting from the disk into either the waste bag or the RBC bag. It also has an off position which prevents flow of fluid out of the disk.

The RBC sensor is an optical sensor which detects when RBCs are exiting the disk. It determines when to stop expressing waste into the waste bag and begin the wash cycle. It then determines when to stop expressing wash into the waste bag and express the washed, concentrated RBCs into the RBC bag.

Header arm

Reservoir brackets

The header arm holds the header portion of the disk stationary during operation. The arm is located on the rear of the deck and folds forward into place. It contains the RBC sensor and positions the sensor appropriately on the disk header.

The reservoir brackets hold the reservoir in place during operation. They mate to tabs on the disposable reservoir which is loaded onto the system by sliding it down the side of the base unit and into the reservoir brackets. The reservoir brackets assure that the reservoir is appropriately positioned for the system to accurately monitor the volume of fluid collected in the reservoir.

The header arm locks into place when it is lowered onto the header. To remove the disk, slide the latch on the back of the arm forward and fold the arm up and back. Inlet valve The inlet valve controls the three-port inlet stopcock which is a component of the disposable set. The valve turns the stopcock to allow either blood from the reservoir, or rinse solution from the saline bag, to enter the disk. It also has an off position which prevents flow of fluid into the disk. RBC bag pins The RBC bag hangs on the pins on the front of the system.

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Reservoir level detector window The reservoir level detector determines the level of fluid in the reservoir. The reservoir level detector window on the side of the system allows the internal camera to monitor the level of a float ball located in a channel of the disposable reservoir. An internal light source illuminates the channel and may cause a visible glow inside the reservoir. Reservoir sensor A microswitch sensor on the side of the OrthoPAT system detects that the reservoir is in place.

OrthoPAT - System Description

Reservoir vacuum port A pneumatic connector on the disposable reservoir fits into the vacuum port to create a passage for air flowing in and out of the reservoir. During intraoperative operation, the port connects to the external wall suction through the wall suction connector on the back of the OrthoPAT system. When the system is used for postoperative autotransfusion, the port connects to the OrthoPAT’s internal pneumatic system.

3-5

Figure 3-4 shows the rear and right side of the base unit. The components are described below.

1. 2. 10.

Retainer ring The retainer ring illustrated in Figure 3-3 is used to secure the disk in the centrifuge chuck. Once the disk is seated in the centrifuge, the retainer ring is fitted between the top of the disk and the lip of the centrifuge. It is removed by gently pulling toward the center of the disk and upward.

Figure 3-3: Retainer ring Note: The retainer ring is NOT disposable. Replace the retainer ring only if damaged or warped.

3. 9.

4.

8.

5.

11. 7.

6.

Figure 3-4: Base unit (rear view) 1. Reservoir vacuum port 2. Battery charge indicator light 3. IV pole clamp 4. Fan 5. Wall suction connector 6. Power cord connector 7. Cable to display unit 8. Power switch 9. Waste bag pins 10. Display unit support post 11. Spill collection bag tray

Battery charge indicator light The battery charge indicator light informs the operator that the system battery is charging. The green light will remain illuminated whenever the system is connected to AC power, regardless of power switch position.

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