CATSmart Operating Instructions Edition Nov 2016

Table of contents 1

2

Important information ... 7 1.1 1.1.1

How to use the Operating Instructions ... 7 Identification ... 7

1.2

Significance of the safety precautions... 8

1.3 1.3.1 1.3.2 1.3.3 1.3.4 1.3.5 1.3.6

Brief description ... 8 General notes ... 8 Advantages of autotransfusion over homologous transfusions ... 8 Historical overview... 9 Special features of the Fresenius CATSmart ... 10 Schematic of autotransfusion with CATSmart ... 12 The continuous washing process ... 13

1.4

Intended use ... 16

1.5 1.5.1 1.5.2

Fields of application... 17 Indications ... 17 Contraindications and possible complications of autotransfusion ... 18

1.6

Target group ... 18

1.7

Duties of the responsible organization ... 18

1.8

Responsibility of the operator... 19

1.9

General warnings ... 20

1.10

Guarantee / warranty... 21

1.11

Exclusion of liability... 22

1.12

Additional equipment (options) ... 22

1.13

Initial start-up... 22

1.14

Maintenance and repair ... 23

1.15

Addresses ... 23

Device description... 24 2.1

CATSmart front view ... 24

2.2

CATSmart rear view ... 25

2.3 2.3.1 2.3.2 2.3.3 2.3.4 2.3.5 2.3.6 2.3.7 2.3.8 2.3.9

Design and function of the individual components of the device ... 26 Display and keyboard ... 26 Centrifuge ... 28 PRC sensor ... 30 Leak detector... 31 Pumps ... 32 Blood and saline sensor unit ... 33 Hematocrit sensor unit... 34 Centrifuge lid ... 35 Cart / IV poles... 36

Fresenius Kabi

CATSmart

OP-EN

11/11.16

1

3

2.4 2.4.1 2.4.2 2.4.3 2.4.4 2.4.5

Description of the washing process ... 37 Priming... 38 “Autostart” function of the CATSmart (optional)... 39 Wash program ... 40 Save final PRC ... 43 Program interruptions ... 44

2.5

Description of the consumables, accessories and additional equipment ... 45

Transport and start-up ... 48 3.1 3.1.1 3.1.2 3.1.3 3.1.4

4

5

Installation / initial start-up ... 50 4.1

Preparatory tasks ... 52

4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6

Connecting ... 53 Connecting vacuum set ... 53 Connecting power supply ... 56 Connecting external devices... 57 Installation of the AT3 autotransfusion set... 58 Connecting autostart... 64 Connection of additional potential equalization (option) ... 65

4.3

Completing installation ... 65

Operation... 66 5.1 5.1.1 5.1.2

Turning CATSmart on and off ... 66 Turning on the CATSmart... 66 Turning off the CATSmart... 67

5.2 5.2.1 5.2.2 5.2.3

Operation of the CATSmart ... 67 Monitor... 67 Operating keys... 68 Description of the display... 68 5.2.3.1 Opening help text ... 71

5.3 5.3.1 5.3.2

Menu description ... 72 Start-up screen ... 72 Settings... 73 5.3.2.1 Date / time setting ... 73 5.3.2.2 Language setting ... 74 5.3.2.3 Configuration of the programs ... 75 5.3.2.4 Sound configuration ... 76 5.3.2.5 Version setting... 77 Changing program ... 78

5.3.3

2

Transport ... 48 Technical information... 48 Transport inside buildings... 49 Overcoming uneven surfaces ... 49 Transport outside buildings... 49

Fresenius Kabi

CATSmart

OP-EN

11/11.16

5.3.4 5.3.5 5.3.6 5.3.7 5.3.8 5.3.9

6

7

5.3.3.1 Selection of the wash program... 78 Install set ... 79 Priming ... 79 5.3.5.1 Skip priming ... 80 5.3.5.2 Standby function ... 80 Wash program ... 82 5.3.6.1 Saving final PRC ... 84 5.3.6.2 Removing set ... 85 Interrupting, continuing or ending a program... 85 Changing the reinfusion bag, the saline bag and the waste bag during blood processing... 86 Data management ... 87 5.3.9.1 Exporting data to USB stick... 88 5.3.9.2 Data export to printer ... 89 5.3.9.3 Scanning data ... 90

5.4 5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.4.6 5.4.7

Description of the blood processing sequence ... 91 Collection of shed blood ... 91 Program sequence ... 95 Program interruptions during blood processing... 99 Program interruption: Collection reservoir empty ... 99 Program interruption: Saline Empty... 99 Program interruption: Failure waste bag ... 99 Changing between the program phases... 100

5.5 5.5.1 5.5.2 5.5.3

Reinfusion ... 101 General warnings on reinfusion... 101 Disconnecting the reinfusion bag ... 102 Connecting the reinfusion bag... 102

Plasma Sequestration ... 103 6.1 6.1.1 6.1.2 6.1.3

Introduction... 103 Indications ... 103 Prerequisites for Plasma Sequestrationon the Fresenius CATSmart... 103 Cautions ... 104

6.2 6.2.1 6.2.2

Description of the Plasma Sequestration Procedure... 105 Program Phases... 105 PSQ Set... 107

6.3 6.3.1 6.3.2 6.3.3

Plasma Sequestration from Blood bags ... 108 Preparation ... 108 Program Run ... 110 Preparing Intraoperative Autotransfusion ... 113

6.4

Reinfusion ... 114

Disposables and consumables ... 115 7.1

General warnings on disposables and consumables... 115

7.2 7.2.1 7.2.2 7.2.3

Disposables ... 116 AT3-Set ... 116 AT1 set ... 117 ATV vacuum lines... 117

Fresenius Kabi

CATSmart

OP-EN

11/11.16

3

8

4

7.2.4 7.2.5 7.2.6

7.2.3.1 ATV - short vacuum line 70 cm ... 117 7.2.3.2 ATV – long vacuum line 180 cm... 117 7.2.3.3 ATS – suction line ... 117 7.2.3.4 Bacterial filter... 117 7.2.3.5 Hydrophobic bacterial filter ... 118 7.2.3.6 Smoke evacuation filter ... 118 Waste bag... 118 Reinfusion bag... 118 Reinfusion bag with Y-adaptor... 118

7.3 7.3.1 7.3.2 7.3.3

Consumables ... 118 Saline... 118 Agents for disinfecting and cleaning the CATSmart ... 118 Printer paper ... 119

7.4 7.4.1 7.4.2 7.4.3 7.4.4 7.4.5

Additional equipment ... 119 Printer ... 119 Shelf... 119 Barcode scanner... 119 Autostart holder ... 119 Vacuum pump... 119

7.5

Part numbers... 120

Failures ... 123 8.1

FAILURE: Blood Flow... 123

8.2

FAILURE: Saline Flow ... 124

8.3

FAILURE: PRC Flow ... 125

8.4

FAILURE: Chamber Lock ... 126

8.5

FAILURE: Centrifuge Speed ... 126

8.6

FAILURE: PRC Sensor ... 127

8.7

FAILURE: Top Light Source ... 128

8.8

FAILURE: Software Configuration ... 128

8.9

FAILURE: Saline, PRC or Blood Pump ... 129

8.10

FAILURE: Centrifuge Leak... 130

8.11

FAILURE: Centrifuge Lid... 131

8.12

FAILURE: Waste Bag... 131

8.13

FAILURE: Transport Protection ... 132

8.14

FAILURE: Vacuum Unit ... 132

8.15

FAILURE: Emergency Stop... 132

8.16

FAILURE: Hct Sensor ... 133

8.17

FAILURE: Plasma Flow (for PSQ) ... 133

Fresenius Kabi

CATSmart

OP-EN

11/11.16

9

Cleaning and maintenance ... 134 9.1

Cleaning and disinfection... 134

9.2

Maintenance... 136

9.3

Complaints ... 136

9.4 9.4.1 9.4.2 9.4.3 9.4.4 9.4.5 9.4.6 9.4.7 9.4.8 9.4.9 9.4.10 9.4.11 9.4.12 9.4.13 9.4.14 9.4.15

Specifications ... 137 Dimensions and weight ... 137 Materials used ... 137 Environmental compatibility / disposal... 138 Centrifuge ... 138 Pumps ... 138 Vacuum Unit (optional) ... 139 IV poles... 139 Electrical safety ... 140 Electrical supply... 140 Guidance and manufacturer's declaration on electromagnetic compatibility for all ME devices and ME systems ... 141 Type label ... 145 Symbols... 146 Fuses... 148 Operating conditions... 148 External connection options ... 149

9.5

Definitions and terms... 149

10 Appendix ... 154 10.1

Further documentation ... 154

10.2

Information on the use of “free software” ... 155

Fresenius Kabi

CATSmart

OP-EN

11/11.16

5

6

Fresenius Kabi

CATSmart

OP-EN

11/11.16

Chapter 1: Important information

1

Important information

1.1

How to use the Operating Instructions

1.1.1

Identification The document can be identified by the following information on the title page and on the labels, if any: – Software version of the CATSmart – 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 1/12.14, for example, refers to: 1st edition, December 2014.

Changes

Changes to the Operating Instructions will be released as new editions or supplements. In general, these instructions are subject to change without notice.

Importance of the instructions

These Operating Instructions are part of the accompanying documents and thus an integral part of the CATSmart. They include information necessary for the use of the CATSmart. The Operating Instructions must be carefully studied before attempting to operate the CATSmart. Before the responsible organization may begin operating the CATSmart, the individual responsible for the operation must have been instructed by the manufacturer on how to use the device and must be thoroughly familiar with the contents of the Operating Instructions. The CATSmart may only be operated by individuals certified on the proper operation and handling of the device.

Fresenius Kabi

CATSmart

OP-EN

11/11.16

7

Chapter 1: Important information

1.2

Significance of the safety precautions Explanation of symbols used: 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 damage to the CATSmart or harm to the environment. Caution Advises the operator that incorrect operation may have adverse effects or cause harm to individuals.

1.3

Brief description

1.3.1

General notes The Fresenius CATSmart – Continuous AutoTransfusion System – is a system designed for intraoperative autotransfusion. CATSmart is the only continuous autotransfusion system working on the principle of the continuous flow centrifuge, comparable to continuous systems for hemapheresis which, for decades, have been widely used in blood banks. The Fresenius CATSmart brings blood bank technology into the operating theater. The Fresenius CATSmart is an autotransfusion system for intraoperative processing of blood from wounds as a consequence of surgery or trauma. The blood from wounds, 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 CATSmart reflects the latest state of technology and complies with the requirements of EN 60601-1 (IEC 60601-1). It is classified as Class IIa (MDD) equipment.

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 normovoletric hemodilution as well as intraoperative and post-operative autotransfusion.

8

Fresenius Kabi

CATSmart

OP-EN

11/11.16

Chapter 1: Important information

“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 (Jehovah's Witnesses) In addition to the above advantages, intraoperative autotransfusion provides the following benefits: – quick and immediate availability of the washed packed red cells at the moment of blood loss and in cases of emergency – high quality packed red cells

1.3.3

Historical overview The concept of collection and reinfusion of a patient's own blood is more than 100 years old. The application of this concept to medical practice was seldom 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, initially directly from donor to recipient, and then later by way of blood stored in blood banks. In parallel autologous blood transfusions were continued. During World War II, blood banks experienced rapid growth; the autologous transfusion methods were neglected and increasingly forgotten. Bottlenecks in the supply of stored blood during the Vietnam War resulted in a revival in the interest in autotransfusions. In 1968, G. Klebanov described a simple technique for returning blood lost during operations. As a result, the Bentley ATS was introduced on the market in the early seventies.

Fresenius Kabi

CATSmart

OP-EN

11/11.16

9

Chapter 1: Important information

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 cells from blood lost during surgery. Simultaneously, the plasma components – plasma, activated clotting factors, anticoagulants – were almost completely separated. This action was undertaken in a discontinuous process in which the individual steps – plasma separation, washing with physiological saline solution, and pumping into a reinfusion bag – were performed consecutively on 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 became established and an integral part of the care of patients requiring blood. The HIV pandemic caused a change in the assessment of the risks related to 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 the continuous flow centrifuge. The introduction in 2004 of C.A.T.Splus, based on C.A.T.S®, represents an advancement while retaining the proven advantages of the fast, high-quality preparation of wound blood. C.A.T.Splus has, compared to C.A.T.S®, improved data management and makes it possible to identify and save the names of the operators, batch numbers for consumables etc. and to export these data for further processing. The introduction of CATSmart in 2015 brought further progress based on C.A.T.Splus while retaining the proven advantages of the fast, highquality preparation of wound blood; Along with the convenient height adjustment and operation of the device via a touch-screen, CATSmart provides a new function for the indication of the hematocrit of the wound blood and of the PRC.

1.3.4

Special features of the Fresenius CATSmart The Fresenius CATSmart is a continuous autotransfusion system in which the blood to be processed is pumped continuously from the reservoir to the washing chamber, washed there and then pumped to the reinfusion bag. It incorporates Hct chamber 1, which monitors the Hct value of the wound blood to be washed, and Hct chamber 2, which monitors the Hct value of the washed packed red cells.

Note Along with the line set AT3, the line set AT1 is also available for the CATSmart (see chapter 7.2.2). On the usage of the line set AT1 it is not possible to monitor the Hct value. This monitoring is only possible on the usage of the line set AT3. The usage of the line set AT3 is a prerequisite for all the following descriptions that involve Hct values. The continuous functional principle has a great number of advantages and a significant influence on the quality of the processed blood product:

10

Fresenius Kabi

CATSmart

OP-EN

11/11.16

Chapter 1: Important information



Simple operation Installation and removal of the disposable system is extremely simple. Operator steps are reduced to a minimum. All components of the disposable systems are preconnected. This eliminates the chance of making mistakes: Loading and unloading the pump lines as well as locking and unlocking the washing chamber is aided by automatic device functions. The correct seating of the Hct chambers in the sensors is aided mechanically by the cover. The washing process is fully automated. A multitude of device functions and process parameters are monitored by microprocessors. If there is an error, clear information and help text on a large touch-screen aid rectification of the cause of the error.



Direct availability of the processed blood for reinfusion Blood processing is started by simply pressing a key or by the autostart function, and stops when all the wound blood in the reservoir has been processed, irrespective of the volume of wound blood collected. The product with washed red cells is available for direct reinfusion.



Constant high quality of the washed packed red cells The hematocrit values of the washed packed red cells are comparable 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 from the subcutaneous depots and the bone marrow are aspirated together with the shed blood. With its specially designed continuous washing chamber, the Fresenius CATSmart separates the fat from the blood cells even before the washing process. The fat is precipitated visibly in the washing chamber and transferred into the waste bag.



Optimal centrifuge speed and centrifugal acceleration In its basic setting, CATSmart operates at speeds  2100 rpm (corresponding to approx. 490 G). Due to the continuous design principle, on average the cells are submitted to the centrifugal force for approx. 30 seconds. Blood, the washed red cells and the saline are pumped through separate lines in a sealless line set, while the waste from the washing chamber passes to the waste bag via an open line. With the CATSmart and the AT3 line set, Fresenius provides an innovative concept with system characteristics that meet the demands on an individualized blood supply.

Fresenius Kabi

CATSmart

OP-EN

11/11.16

11

Chapter 1: Important information

1.3.5

Schematic of autotransfusion with CATSmart Typically, intraoperative autotransfusion using CATSmart 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 a vacuum, anticoagulated and collected in a reservoir. Coarse particles are removed from the blood by means of a filter (40 μm or 120 μm) that is incorporated in the reservoir (Fresenius reservoir). A vacuum pump (Fresenius aspiration assembly) generates the required vacuum.



Blood processing Subsequently, the blood is processed in the CATSmart. The blood collected in the reservoir is continuously processed to obtain washed packed red cells with a high hematocrit and a reduced portion of plasma, plasmatic elements, white blood cells and platelets. Isotonic saline solution is used as the washing solution during blood processing. Used saline is collected in a waste bag.



Reinfusion The packed red cells are collected in a reinfusion bag. From this bag they can be reinfused to the patient via a transfusion set when needed.

Fig. 1: Schematic of autotransfusion

12

Fresenius Kabi

CATSmart

OP-EN

11/11.16

Chapter 1: Important information

1.3.6

The continuous washing process

Fig. 2: Washing process The wound blood is washed in the line set using a sealless chamber. The blood pump draws the wound blood out of the reservoir to the washing chamber. The blood sensor monitors that there is blood in the system and signals if the reservoir is empty. If the reservoir is empty, the process pauses automatically until more blood for washing is available in the reservoir. The wound blood flows through the Hct chamber that monitors the cell content in the wound blood. In the washing chamber the wound blood is continuously washed in three successive phases: 1st concentration phase, washing phase, and the 2nd concentration phase.

Fresenius Kabi

CATSmart

OP-EN

11/11.16

13

Chapter 1: Important information

The washed packed cells are then pumped to the reinfusion bag by the PRC pump; during this process they pass through the second Hct chamber, which monitors the concentration of the cells in the product. The PRC pump starts to collect once a specific fill level has been reached at the outlet from the washing chamber. It operates continuously as long as the PRC sensor detects a specific fill level. The PRC pump stops if the fill level drops below a level defined by the system to prevent dilution of the PRC product. The packed red cells in the reinfusion bag are available for reinfusion at any time. During the washing process the wound blood is pumped to the chamber's inner inlet. After the initial hemoconcentration in the first chamber phase the cells are washed with saline in the second stage; this saline solution is pumped into the second chamber phase. A sensor monitors for the presence of this saline. If the saline bag is empty, the process stops automatically such that an additional saline bag can be connected. The PRC pump pumps the washed cell fraction out of the chamber, while the saline and the cellular debris leave the separation chamber via the open line at the innermost point in the chamber. 1

5

2 3



4

Direction of rotation

Fig. 3: Separation chamber

14

1

Spiral channel

2

PRC port

3

Blood port

4

Saline port

5

Waste port

Fresenius Kabi

CATSmart

OP-EN

11/11.16

Chapter 1: Important information

The washing process takes place at the outside of the spiral separation chamber. The blood to be processed enters the channel at the innermost point on the spiral, the blood port. From here it flows continuously through the entire channel. The washed red cells are removed at the outermost point of the spiral, the PRC port. Saline is added to the channel at the saline port. Used saline and the separated plasma, which also contains the cellular debris, leave the chamber at the waste port. Waste port

Blood port

PRC Saline port 2nd separation chamber phase

Washing phase

1st separation chamber phase

Fig. 4: “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 phases. The above figure schematically illustrates the rolled-out channel.



1st separation phase The initial separation phase 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 non-emulsified fat-droplets flow inwards 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 whiteyellowish layer of fat is visible in the inner channel of the washing chamber. The 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 during which process the separation of fat and blood cells is ensured.

Fresenius Kabi

CATSmart

OP-EN

11/11.16

15

Chapter 1: Important information



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 is in 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 % independently of the chosen wash program. At the PRC port a small “pool” of washed packed red cells accumulates. The fill 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 processing, the major part of this volume can be removed in a controlled manner from the washing chamber by the Hct chamber in the product line in the program phase Save final PRC.

1.4

Intended use The CATSmart (Continuous Autotransfusion System) from Fresenius is an autotransfusion system that prepares autologous blood collected intraoperatively or postoperatively such that a concentrate of washed red cells is obtained. The CATSmart is designed for use in the surgical field of hospitals.

16

Fresenius Kabi

CATSmart

OP-EN

11/11.16

Chapter 1: Important information

1.5

Fields of application Use of the Fresenius CATSmart should generally be considered with all surgical treatments permitting blood collection 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 system 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 CATSmart. This statement is applicable to both intraoperative 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) The washed packed red cells contain only low quantities of clotting factors. The quantity of reinfused red cells should be monitored and, if necessary, supplemented with platelets and fresh plasma.

1.5.1

Indications Fresenius CATSmart 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 / washing process and the transfer of the washed packed red cells into a reinfusion bag for reinfusion by gravity.

Fresenius Kabi

CATSmart

OP-EN

11/11.16

17

Chapter 1: Important information

1.5.2

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 CATSmart 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 responsibility for the usage of the CATSmart lies exclusively with the attending physician. Complications can be associated with the transfusion of large blood volumes, the 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.

1.6

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

1.7

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 CATSmart – Permanent availability of the Operating Instructions

18

Fresenius Kabi

CATSmart

OP-EN

11/11.16

Chapter 1: Important information

1.8

Responsibility of the operator On the usage of the CATSmart the related applicable national regulations are to be followed (in Germany e.g. Querschnitts-Leitlinien (BÄK) zur Therapie mit Blutkomponenten und Plasmaderivaten (CrossSectional Guidelines for Therapy with Blood Components and Plasma Derivatives) - 4th edition 2008). The usage of the medical product lies within the area of responsibility of the attending physician. The following must be observed when entering parameters: The parameters entered must be verified by the operator, i.e. the operator must check that the values entered are correct. If the check reveals a deviation between the desired parameters and the parameters displayed on the CATSmart, the setting must be corrected before activating the function. The actual values displayed must be compared with the desired values specified!

Caution The CATSmart has no essential performance, which guarantees under all circumstances, such as power failure, the quality of the product. It is the responsibility of the user to check the quality of the product, which is produced with the CATSmart device.

Fresenius Kabi

CATSmart

OP-EN

11/11.16

19