CATSplus Operating Instructions Edition May 2007

Table of Contents Section

Page

0

General Notes ...

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1 1.1 1.2 1.3

Important Information ... How to use the Operating Instructions ... Significance of the Safety Precautions ... Brief Description ... 1.3.1 General Notes ... 1.3.2 Advantages of Autotransfusion Over Homologous Transfusions ... 1.3.3 Historical Overview ... 1.3.4 Special Features of the Fresenius C.A.T.Splus ... 1.3.5 Schematic of Autotransfusion with C.A.T.Splus ... 1.3.6 The Continuous Washing Process ... Intended Use ... 1.4.1 Fields of Application ... 1.4.2 Indications ... 1.4.3 Contraindications and Possible Complications of Autotransfusion ... Target Group ... Duties of the Responsible Organization ... Operator Responsibility ... Warnings ... Guarantee / Warranty ... Disclaimer of Liability ... Accessories (Options) ... Initial Start-up ... Maintenance and Repair ... Addresses ...

1-1 1-1 1-2 1-3 1-3 1-3 1-4 1-5 1-6 1-7 1-10 1-10 1-10 1-11 1-12 1-12 1-12 1-13 1-15 1-15 1-16 1-16 1-16 1-17

Device Description ... C.A.T.Splus Front View ... C.A.T.Splus Rear View ... Structure and Function of the Individual Device Components ... 2.3.1 Display and Keyboard ... 2.3.2 Centrifuge ... 2.3.3 PRC Sensor ... 2.3.4 Leakage Detector ... 2.3.5 Pumps ... 2.3.6 Blood and Saline Sensor Unit ... 2.3.7 Centrifuge Cover ... 2.3.8 Cart and IV Pole ... 2.3.9 Battery Operation ... Description of the Washing Procedure ... 2.4.1 Priming ... 2.4.2 Wash Program ... 2.4.3 Saving Final PRC ... 2.4.4 Program Interruptions ...

2-1 2-1 2-2 2-3 2-3 2-4 2-6 2-7 2-7 2-9 2-10 2-10 2-11 2-12 2-13 2-14 2-18 2-18

1.4

1.5 1.6 1.7 1.8 1.9 1.10 1.11 1.12 1.13 1.14 2 2.1 2.2 2.3

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Section

Page

2.5

Description of Accessories ... 2.5.1 Thermal Printer ... 2.5.2 Printer Holder ... 2.5.3 Bar Code Scanner ... 2.5.4 USB Mo.U.S.E ... 2.5.5 Configuration Program Euk@lyptus ... 2.5.6 Part Numbers ...

2-19 2-19 2-19 2-20 2-20 2-20 2-20

3 3.1 3.2

Operation ... Start-Up ... Device Operation ... 3.2.1 Operating Keys... 3.2.2 Display Description ... 3.2.3 Program Phase and Status ... 3.2.4 How to Display Help Texts ... 3.2.5 How to Interrupt the Program ... 3.2.6 Options ... 3.2.7 Program Selection and Configuration ... 3.2.8 Printer Records ... 3.2.9 Stand By Function ... 3.2.10 Setting the Date and Time ... 3.2.11 Language Selection... 3.2.12 Indication of Software Versions ... 3.2.13 Centrifuge Lid ... 3.2.14 IV Pole ... Collection of Shed Blood ... Program Run ... 3.4.1 Selection of the Wash Program ... 3.4.2 Installation of the AT1 Autotransfusion Set ... 3.4.3 Priming of the AT1 Autotransfusion Set ... 3.4.4 Connection of the Blood Collection Reservoir ... 3.4.5 Wash Program ... 3.4.6 Changing the Processing Speed of the Wash Program ... 3.4.7 Changing the Wash Program ... 3.4.8 Program Interruption: Collection Reservoir Empty ... 3.4.9 Program Interruption: Saline Empty ... 3.4.10 Program Interruption: Alarm: Waste Bag ... 3.4.11 Save Final PRC ... 3.4.12 Removal of the AT1 Autotransfusion Set ... 3.4.13 How to Change Between Program Phases ... Reinfusion ... 3.5.1 Disconnection of the Reinfusion Bag ... 3.5.2 Connection of the Reinfusion Bag ...

3-1 3-1 3-3 3-3 3-3 3-6 3-8 3-9 3-10 3-18 3-20 3-22 3-23 3-24 3-24 3-25 3-25 3-26 3-28 3-28 3-29 3-35 3-35 3-36 3-36 3-37 3-38 3-39 3-40 3-41 3-42 3-44 3-45 3-46 3-46

3.3 3.4

3.5

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Section

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4 4.1 4.2

Disposables and Consumables ... General Notes ... Disposables ... 4.2.1 AT1 Autotransfusion Set ... 4.2.2 Waste Bag ... 4.2.3 Reinfusion Bag ... 4.2.4 Reinfusion bag with Y-Connector ... Consumables ... 4.3.1 Saline ... 4.3.2 Disinfectants and Cleaning Agents ... 4.3.3 Thermal Printer Paper ... Part Numbers ...

4-1 4-1 4-2 4-2 4-3 4-3 4-3 4-4 4-4 4-4 4-4 4-5

Failures and Alarms ... Failures ... 5.1.1 FAILURE: Blood Flow ... 5.1.2 FAILURE: Saline Flow ... 5.1.3 FAILURE: PRC Flow ... 5.1.4 FAILURE: Chamber Lock ... 5.1.5 FAILURE: Locking Blocked ... 5.1.6 FAILURE: Centrifuge Speed ... 5.1.7 FAILURE: PRC Sensor ... 5.1.8 FAILURE: Top Light Source ... 5.1.9 FAILURE: Chamber Edge ... 5.1.10 FAILURE: ADW Reference ... 5.1.11 FAILURE: Timeout ... 5.1.12 FAILURE: CAN ... 5.1.13 FAILURE: CRC-Checksum ... 5.1.14 FAILURE: Software Configuration ... Alarms ... 5.2.1 ALARM: Saline, PRC or Blood Pump ... 5.2.2 ALARM: Centrifuge Leak ... 5.2.3 ALARM: Centrifuge Lid ... 5.2.4 ALARM: Locking Sensor ... 5.2.5 ALARM: Power Failure ... 5.2.6 ALARM: Waste Bag ... 5.2.7 ALARM: Door Lock ... 5.2.8 ALARM: Locking Mechanism ... 5.2.9 ALARM: CCD Camera ...

5-1 5-1 5-1 5-2 5-3 5-3 5-4 5-4 5-5 5-5 5-6 5-6 5-6 5-6 5-7 5-7 5-8 5-8 5-9 5-9 5-10 5-10 5-11 5-11 5-12 5-12

Blood Transfer ... Introduction ... 6.1.1 Warnings ... Blood Transfer (190) ... 6.2.1 Description ... 6.2.2 Program Operation: Blood Transfer (190) ... 6.2.3 Changing the Program ... Blood Transfer (350) ... 6.3.1 Description ... 6.3.2 Program Operation: Blood Transfer (350) ... 6.3.3 Changing the Program ... Reinfusion ...

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4.3

4.4 5 5.1

5.2

6 6.1 6.2

6.3

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Section

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7 7.1

Plasma Sequestration ... Introduction ... 7.1.1 Indications ... 7.1.2 Prerequisites for Plasma Sequestration on the Fresenius C.A.T.Splus ... 7.1.3 Cautions ... Description of the Plasma Sequestration Procedure ... 7.2.1 Program Phases ... 7.2.2 PSQ Set... 7.2.3 PSQ Direct Draw Set... Plasma Sequestration From Blood Bags ... 7.3.1 Preparation ... 7.3.2 Program Run ... 7.3.3 Preparing Intraoperative Autotransfusion ... Plasma Sequestration (Direct Draw) ... 7.4.1 Preparation ... 7.4.2 Program Run ... 7.4.3 Preparing Intraoperative Autotransfusion ... Reinfusion ...

7-1 7-1 7-1 7-1 7-2 7-3 7-4 7-5 7-6 7-7 7-7 7-9 7-13 7-14 7-14 7-17 7-24 7-25

Cryo Wash ... Introduction ... 8.1.1 Indication ... 8.1.2 Prerequisites for Deglycerolization of Cryopreserved RBC with the Fresenius C.A.T.Splus ... 8.1.3 Cautions ... Description ... 8.2.1 Program Phases ... 8.2.2 Cryo Set... Deglycerolization ... 8.3.1 Preparation ... 8.3.2 Program Run ... 8.3.3 Preparing Intraoperative Autotransfusion ... Reinfusion ...

8-1 8-1 8-1

7.2

7.3

7.4

7.5 8 8.1

8.2

8.3

8.4

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Section

Page

9 9.1 9.2

Technical Information ... Storage ... Transportation ... 9.2.1 Transportation Within Buildings ... 9.2.2 Overcoming Uneven Surfaces ... 9.2.3 Transportation Outside of Buildings ... Start-Up / First Start-Up ... Cleaning and Disinfection ... Maintenance ... Complaints ... Specifications ... 9.7.1 Dimensions and Weight ... 9.7.2 Materials Used ... 9.7.3 Disposal of Products After Use ... 9.7.4 Centrifuge ... 9.7.5 Blood, PRC, Saline Pumps ... 9.7.6 IV Pole ... 9.7.7 Electrical Safety ... 9.7.8 Electrical Supply ... 9.7.9 Electromagnetic Compatibility ... 9.7.10 Type Label ... 9.7.11 Symbols ... 9.7.12 Fuses ... 9.7.13 Operating Conditions ... 9.7.14 External Connection Options ... 9.7.15 Noise Level ... Definitions and Terms ... Certificates ... 9.9.1 EC Declaration of Conformity ...

9-1 9-1 9-2 9-2 9-2 9-2 9-3 9-4 9-5 9-6 9-7 9-7 9-7 9-7 9-8 9-8 9-8 9-8 9-9 9-10 9-13 9-14 9-15 9-15 9-16 9-17 9-18 9-21 9-21

Appendix ... Literature ... Information Regarding the Use of “Free Software” ...

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9.3 9.4 9.5 9.6 9.7

9.8 9.9

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1

Important Information

1.1

How to use the Operating Instructions ● Identification The document can be identified by the following information on the title page and on the labels, if any: – Software version of the system – Edition of the technical document – Part number of the technical document ● Page identification The page identification 1-3, for example, refers to chapter 1, page 3. ● Editorial information The editorial information 1/01.05, for example, refers to: 1 st edition, January 2005. ● Changes Changes to the Operating Instructions will be released as new editions or supplements. In general – this manual is subject to change without notice. ● Importance of the instructions The Operating Instructions are part of the accompanying documents and are an essential part of the system. They include information necessary for the use of the system. The Operating Instructions must be carefully studied before attempting to operate the system. Before the responsible organization may begin operating the system, the individual responsible for the operation must have been instructed by the manufacturer on how to use the system and must be thoroughly familiar with the contents of the Operating Instructions. The system may only be operated by individuals certificated to have been instructed on the proper operation and handling of the unit.

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1.2

Significance of the Safety Precautions Explanation of the Note and Caution symbols used:

Caution Advises the operator against certain procedures or actions that could cause damage to the equipment or may have adverse effects on individuals.

☞

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Note Informs the operator that failure to follow the steps as specified may result in the specific function not being executed correctly, not being executed at all, or not producing the desired effect.

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1.3

Brief Description

1.3.1

General Notes The Fresenius C.A.T.S plus – Continuous AutoTransfusion S ystem – is a system designed for intraoperative autotransfusion. The C.A.T.Splus device is the first continuous autotransfusion system working on the principle of a continuous flow centrifuge, comparable to continuous systems for hemapheresis which, for decades, have been widely used in blood banks . The Fresenius C.A.T.Splus device brings blood bank technology into the operating room. The Fresenius C.A.T.Splus device is an intraoperative autotransfusion system for intra- and/or postoperative processing of blood lost through surgery or trauma. The shed blood, which is anticoagulated and collected in a sterile reservoir, is processed in a continuous washing process to obtain washed packed red cells for reinfusion to the patient. During this process all plasmatic and non-erythrocytic cellular components of the collected blood , and thus activated coagulation factors, products of fibrinolysis and cell trauma as well as the anticoagulant are removed. The C.A.T.Splus system reflects the latest state of technology and complies with the requirements of EN 60601-1 (IEC 601-1). It is classified as Class IIa equipment (MDD).

1.3.2

Advantages of Autotransfusion Over Homologous Transfusions The term “autologous blood” refers to the blood which is derived from the same individual. “Autotransfusion" is therefore the procedure in which the blood lost by or removed from a patient is subsequently returned to the patient's circulatory system. This includes all procedures of autodonation, acute normovolemic hemodilution as well as intraoperative and postoperative autotransfusion. “Homologous” blood or foreign blood, on the other hand, is donor blood from sources other than the patient who is receiving it. During the past decades, autotransfusion has gained widespread acceptance and should be given preference over homologous transfusion. The advantages of autotransfusion are well documented and can be considered to be generally accepted. The major advantages are as follows: – no blood-related disease transmission risk – no transfusion reactions – no immunosuppression or immunization – elimination of blood grouping and cross-matching errors – accepted by patients opposed to homologous transfusion for religious reasons (Jehova’s Witnesses) In addition to the above advantages, intraoperative autotransfusion provides the following benefits: – quick and immediate availability at the moment of blood loss and in cases of emergency, – high quality packed red cells.

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1.3.3

Historical Overview The concept of collection and reinfusion of a patient's own blood is more than 100 years old. Application of this concept to medical practice was seldom employed and was restricted to emergency situations where severe blood loss and/or lack of available blood from donors put the life of the patient at risk. In 1818 James Blundell was the first to report about successful transfusion experiments with dogs and suggested the reinfusion of autologous blood. He was the first to perform blood transfusions from man to man. First attempts failed, but successful transfusions followed. In 1874, James Highmore suggested the reinfusion of post partum blood and reported successful reinfusions. In 1886, John Duncun collected blood from a patient's amputated leg and returned the blood via the femoral vein. Since the discovery of the blood groups by Karl Landsteiner in 1901, the development of anticoagulants, and storage of blood , the use of foreign blood transfusions increased. This first happened directly from donor to recipient and then later by way of blood stored in blood banks. During World War II, blood banks experienced a rapid growth and were relied upon until the Vietnam War, when bottlenecks developed that restricted the availability of blood. Although the evolution of transfusion of autologous blood had continued, interest in autologous transfusions was not revived until the supply of banked blood declined. In 1968, G. Klebanov described a simple technique for returning blood lost during operation. As a result, the Bentley ATS was introduced on the market in the early seventies. In 1975, M. Orr and R. Gilcher used the centrifuge-based blood washing technique developed by Latham in surgery. The goal of the procedure was the recovery of red blood cells from blood lost during surgery. Simultaneously, the plasma components – plasma, activated clotting factors, anticoagulants – were almost completely separated.This was done in a discontinuous process, in which the individual steps – plasma separation, washing with physiological saline solution, and pumping into the reinfusion bag – were performed consecutively using one unit of blood. The volume of the blood unit was defined by the volume of the bowl used. In the years that followed, the practice of intraoperative autotransfusion has become the standard of care for patients requiring blood. The HIV pandemia caused a change in the assessment of the risks connected with foreign blood transfusions. The 1994 introduction of the Fresenius C.A.T.S® system represents the first continuous autotransfusion system based on the principle of a continuous flow centrifuge. The 2004 introduction of C.A.T.Splus represents an advancement based on C.A.T.S ® which, while retaining the approved advantages of a fast and high-quality preparation of wound blood, offers the following new functions: – Data management Collection of – operator identification – type of operation – operation ID – patient identification – batch identification – Data transfer Transfer of procedure data by means of USB Mo.U.S.E for external processing.

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1.3.4

Special Features of the Fresenius C.A.T.Splus The Fresenius C.A.T.Splus device is the first continuous autotransfusion system. In a continuous autotransfusion system, the blood to be processed flows through a continuous washing chamber, which is divided into various functional areas where the different phases of the processing procedure are running simultaneously. This procedure provides for a continuous flow of blood cells, from the delivery of the blood out of the collection reservoir, via the processing procedure in the washing chamber, until the blood is pumped off into the reinfusion bag for direct reinfusion. The continuous functional principle has a great number of advantages and a significant influence on the quality of the processed blood product: – Simple operation Installation and removal of the disposable set is extremely simple. Operator steps are reduced to a minimum. All components of the disposable system are preconnected. Mistaking the lines is excluded. Threading in and out of the pump lines as well as locking and unlocking of the washing chamber is supported by automatic device functions. The washing process is fully automated. A multitude of device functions and process parameters are monitored by microprocessors. Error messages and help texts for their elimination are displayed in plain language on a large-size graphic screen. – Direct availability of the processed blood for reinfusion Blood processing is started by simply pressing a key and stops when the complete blood volume has been processed to obtain washed packed red cells, irrespective of the volume collected. The processed blood is available for direct reinfusion. The C.A.T.Splus device is therefore also suitable for pediatric applications. – High processing speeds The user selects the desired program from various wash programs with different washing efficiencies and automatically adjusts the processing speed (up to 100 ml of packed red cells per minute at a hematocrit of ~65 %) to the transfusion requirements by simply pressing a key. – Constant high quality of the washed packed red cells The hematocrits of the washed packed red cells can be compared with the autologous or homologous packed red cells from blood banks. They offer high therapeutical safety. – Separation of non-emulsified fats Particularly during major orthopedic surgery, considerable amounts of fat are withdrawn from the subcutaneous depots and the bone marrow together with the shed blood. With its specially designed continuous washing chamber, the Fresenius C.A.T.Splus device separates the fat from the blood cells even before the washing process. The fat is precipitated at the inner surface of the washing chamber and transferred into the waste bag. – Low centrifuge speed and centrifugal acceleration In its basic setting, C.A.T.Splus works at speeds below 2000 rpm (corresponding to approx. 490 G). Owing to the continuous design principle, the cells are on average submitted to the centrifugal force for approx. 30 seconds. Blood, washed packed red cells, saline and waste are pumped through separate lines of a sealless line set. With the C.A.T.Splus autotransfusion set, Fresenius provides an innovative concept which, through advanced features, particularly meets the demands of an individualized blood supply.

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1.3.5

Schematic of Autotransfusion with C.A.T.Splus Typically, intraoperative autotransfusion with C.A.T.Splus is performed according to the procedure below: – Blood collection Using a surgical suction tip and a suction line (Fresenius double-lumen suction line ), the blood is aspirated from the site of operation by means of vacuum pressure, anticoagulated and collected in a reservoir. Coarse particles are removed from the blood by means of a filter (40 μm or 120 μm) which is incorporated in the reservoir (Fresenius reservoir with blood collection bag). A vacuum pump (Fresenius aspiration assembly) generates the required vacuum. – Blood processing Subsequently, the blood is processed by means of the C.A.T.S plus device. The blood collected in the reservoir is continuously processed to obtain washed packed red cells with a high hematocrit and a reduced portion of white blood cells and platelets. Isotonic saline solution is used as washing solution during blood processing. Used washing solution is collected in a waste bag. – Reinfusion The packed red cells are collected in a reinfusion bag from which they can be reinfused to the patient via a transfusion set when needed.

Suction line

Anticoagulant

Washing solution

Reinfusion bag

Transfusion set Patient

Cup

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Blood collection bag

Fresenius Kabi C.A.T.Splus

C.A.T.S Plus

Waste bag

Regulator

Vacuum pump / inhouse vacuum system

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1.3.6

The Continuous Washing Process

Blood reservoir

Waste bag

Shed blood

Washing solution (saline)

Blood sensor

Saline sensor

Blood pump

Saline pump

1st separation stage

Plasma + washing solution

Reinfusion bag Washed packed red cells

PRC pump

Washing stage

2nd separation stage

Washing chamber

C113/C113e

The shed blood is processed in a sealless washing chamber which is connected to the remaining line set. The blood pump drives the shed blood collected in the reservoir into the washing chamber where it is continuously processed in three successive stages. The washed packed red cells are then transferred into the reinfusion bag by the PRC pump. The PRC pump continuously delivers the washed packed red cells from the washing chamber into the reinfusion bag where they are available for reinfusion. The red blood cells are washed with saline delivered by means of the saline pump. The waste saline is drained into the waste bag. The blood and saline sensors monitor the blood and saline supply to the washing chamber. The washing process is paused automatically in case the blood reservoir or the saline bag is empty.

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Waste port Spiral blood channel Saline port PRC port Blood port

Direction of rotation

The washing process takes place in a spiral channel along the outside of the separation chamber. The blood to be processed enters the channel on the inner loop at the blood port, from where it continuously flows through the entire channel. The washed red blood cells are removed from the outermost point ot the spiral at the PRC port. Saline is added at the saline port. Used saline solution and separated plasma leave the channel at the waste port.

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Waste port

PRC port

Blood port

2nd separation chamber phase

Saline port Washing phase

1st separation phase

“Rolled out” channel of the washing chamber viewed from above. The lower section of the drawing represents the outer section in the centrifuge. The slope illustrates the difference in the centrifugal force resulting from the spiral-shaped design of the washing chamber. Blood that enters the channel flows from the point of least centrifugal force (blood port) "down" to the point of highest centrifugal force (PRC port).

The washing process in the double spiral blood channel comprises three successive stages. The above figure schematically illustrates the rolled-out channel.

1st Separation Phase The initial separation stage comprises the section between the blood port and the saline port. Here, the blood is concentrated to an hematocrit of approx. 80%. During this phase the major part of the blood plasma, cellular debris, white blood cells, platelets, anticoagulant, other liquid constituents and non-emulsified fat are separated. Because the channel has a slope, the blood cells flow in a thin layer on the outside wall of the channel. The liquid constituents and nonemulsified fat-droplets are driven to the waste port . Non-emulsified fat droplets are separated from the blood in a highly effective manner, as their low density causes them to remain in the inner section of the washing chamber and prevents them from reaching the outer PRC port. Upon completion of the separation process, a white-yellowish layer of fat is visible in the inner channel of the washing chamber. Transfer of the fat precipitated at the inner channel of the washing chamber into the reinfusion bag is excluded, as the packed red cells are only collected while the centrifuge is running which ensures the separation of fat and blood cells.

Washing Phase The washing takes place in the saline port section. Here the red blood cells are resuspended with saline. 2nd Separation Phase The second separation phase comprises the section between the saline port and the PRC port. Here the used saline is removed and the blood is concentrated to an hematocrit of >50%. At the PRC port a small "pool" of washed packed red cells is accumulated. The filling level of this pool is monitored from the outside by the PRC sensor and is kept constant by the PRC pump. At the beginning of the processing procedure, this pool (approx. 30 – 50 ml) must have accumulated, before packed red cells can be continuously collected from the washing chamber. At the end of the processing procedure, the major part of this volume can be removed from the chamber in the Save Final PRC phase.

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1.4

Intended Use

1.4.1

Fields of Application Use of the Fresenius C.A.T.Splus device should generally be considered with all surgical treatments permitting blood salvage without excess hemolysis. The following criteria could be helpful in the decision-making process: – operations where banked blood is generally cross-matched prior to the operation – operations where the typical transfusion volume exceeds 1 unit of blood, – collection of more than one liter of shed blood. Collection of the shed blood in a sterile blood collection reservoir with anticoagulation is generally recommended in fields of application where more than 10% of the patients require autotransfusion to provide the option to process the shed blood with the Fresenius C.A.T.Splus device. This is applicable to both intra- and postoperative blood losses. The use of autotransfusion systems has proven to be particularly beneficial in the following fields of application: – cardio-thoracic surgery, – vascular surgery, – orthopedics (replacement of joints, vertebral columns) – liver transplantations, – ectopic pregnancy, – urology (prostatectomy), – oncology (reinfusion bag irradiatable).

1.4.2

Indications The Fresenius C.A.T.S plus device is indicated for the processing of blood collected intraoperatively or postoperatively or after trauma, under sterile conditions and under anticoagulation. Processing of the blood comprises a separation and washing phase and the transfer of the washed packed red cells into a reinfusion bag for reinfusion by gravity.

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1.4.3

Contraindications and Possible Complications of Autotransfusion The risk/benefit ratio of intraoperative autotransfusion must be determined on an individual basis by the physician involved in the patient's care.

Caution Use of the Fresenius C.A.T.Splus device may be contraindicated in the case of sepsis or presence of malignant tumors. Autotransfusion is contraindicated for blood contaminated by BETADINE, hydrogen peroxide, distilled water, water, alcohol, antibiotics not permitted for parenteral use, fibrin glue, Aviten, or collagen-based hemostatics. Autotransfusion is contraindicated in the event of sepsis and contamination with meconium, urine, intestinal and gastric contents, bile and amniotic fluid. The attending physician bears the sole responsibility for the use of the device.

Complications can be associated with transfusion of large blood volumes, administration of excessive anticoagulant and hemolysis. Complications include elevated levels of free hemoglobin, hemoglobinuria, hematuria, air embolism, citrate toxicity, depression of serum calcium, septicemia, and pulmonary complications.

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1.5

Target Group The system may only be installed, operated and used by individuals with the appropriate training, knowledge and experience.

1.6

Duties of the Responsible Organization The responsible organization assumes the following responsibilities: – Compliance with the national or local installation, operation, use and maintenance regulations. – Compliance with the accident prevention regulations – Correct and safe condition of the system. – Permanent availability of the Operating Instructions.

1.7

Operator Responsibility The following must be observed when entering parameters: The parameters entered must be verified by the operator, i.e. he must check the values entered to ensure they are correct. Should the check show deviations between the desired parameters and those indicated on the device, the setting must be corrected before the respective function is activated. Always compare the indicated actual values with the specified rated values!

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1.8

Warnings

Caution – It is always possible that the processed blood is infectious. It must therefore always be treated as being potentially infected. – Maintain sterile technique throughout all stages of the set-up and use of the autotransfusion set and the blood collection system. – The washed packed red blood cells are depleted of clotting factors. The quantity of the retransfused red blood cells should be monitored and, if required, completed by platelets and fresh plasma. – The autotransfusion set, the blood collection system and the packed red blood cells should be used within 6 hours of initiating the collection, since as a matter of principle, bacterial contamination by air-borne organisms cannot be excluded during blood collection. – Shed blood must be anticoagulated prior to aspiration into the C.A.T.Splus device. Non- or insufficiently anticoagulated blood can cause clotting and the transfer of blood clots into the AT1 set. These blood clots will then be present in the processed blood product and can cause clogging of the system. Check for clot formation in the collection reservoir (outside the filter) and add anticoagulant as appropriate. Anticoagulation with heparin: Heparinised saline solution may be used for anticoagulation during blood collection. It is recommended to use a solution of 30,000 IU of heparin per 1 liter of isotonic saline solution with a dosage of 20 ml of solution per 100 ml of blood. Anticoagulation with CPD (citrate phosphate dextrose) – USP: CPD solution can also be used for anticoagulation during blood collection. It is recommended to use a quantity of 15 ml CPD per 100 ml of collected blood. The quantity of anticoagulant introduced in the blood collection system must be adapted to the quantities of shed blood incurred. 60 to 80 drops of heparin solution per minute or 45 to 60 drops of CPD per minute represent typical values. – The quality of the washed packed red cells is directly dependent upon the quality of the collected shed blood. The quality of the shed blood, in turn, is dependent upon the field of application and is essentially influenced by the suction method and the applied vacuum pressure. The vacuum pressure should always be set as low as possible. Typically, it should not exceed values of –100 mmHg. – Do not use irrigation fluids that are either hypo- or hypertonic which may lead to hemolysis. – Avoid aspiration of collagen-based or local hemostatics to help prevent coagulation of the shed blood. – Prior to reinfusion, insure that the reinfusion blood filter and reinfusion set are primed and that all air is removed, to avoid the possibility for air embolism. – Avoid aspiration of blood mixed with air from the surgical field (surface skimming) which may lead to increased hemolysis . Use an adequately sized suction tip to prevent excess hemolysis.

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Caution – Before reinfusing the processing product, the user must verify its suitability for transfusion. As a typical product, the C.A.T.Splus device delivers packed red cells with a hematocrit ~65 %. Diluted PRC indicate a malfunction of the device and can be accompanied by reduced washing results. In case of doubt, the quality of the packed red cells must be checked. – To minimize the risk of air embolism, DO NOT REINFUSE BY PRESSURE . – Do not allow the reinfusion bag to become completely empty during reinfusion to the patient. Should air be present in the reinfusion line, all air must be removed before continuing the reinfusion procedure. – For reasons of technical safety, do not remove the inspection cover on the rear panel to prevent electric shock. Refer servicing of the device to qualified and skilled personnel authorized by the manufacturer to do so. Every precaution has been made to prevent the operator and others from coming in contact with any rotating parts of the centrifuge. The C.A.T.Splus device is equipped with an electromagnetic centrifuge cover lock.. The centrifuge can not be operated if the centrifuge lid is not properly locked. DO NOT ATTEMPT TO DEFEAT, REMOVE OR OVERRIDE ANY OF THE SAFETY MECHANISMS OF THE C.A.T.Splus AUTOTRANSFUSION SYSTEM. – Do not reinfuse blood directly to the patient while blood is still collecting in the reinfusion bag. Prior to reinfusion of the washed packed red cells, the reinfusion bag must be disconnected from the AT1 autotransfusion set. To continue the blood processing procedure while reinfusing washed packed red cells, a new blood bag must be connected to the AT1 autotransfusion set. – The C.A.T.Splus device may not be used in explosion-hazardous areas. If the C.A.T.Splus device is used in operating rooms where ignitable respiratory gas mixtures are used at the same time the specified operating distance to the closed respiratory gas system must be adhered to. The use of inflammable hand cleaning substances and disinfectants presents an explosion hazard. – If the C.A.T.Splus device is operated in medical rooms, the regulations for the setup for electrical installations in these rooms must be adhered to (German Standard VDE 0107). – Do not use devices emitting electromagnetic radiation (e.g. walkie-talkies, portable phones, radio transmitters) in the vicinity of the C.A.T.Splus system in operation. This may causes a malfunction of the C.A.T.Splus system. – If disturbances caused by electrical interference sources (e.g. HF surgical instruments, short-wave and micro-wave therapeutical equipment) arise, the distance to the respective interference source should be increased.

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Fresenius

Kabi C.A.T.Splus

6/05.07 (OP)