autoLog Operators Manual Rev 00

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PROPRIETARY INFORMATION The entire contents of this manual are copyrighted and the property of Medtronic, Inc. No part of this book may be used or reproduced in any form or by any means, or stored in a database or retrieval system, without the prior written authorization of Medtronic, Inc. Classified by Underwriters Laboratories, Inc.® with respect to electric shock, fire and mechanical hazards only in accordance with UL 2601-1 and CSA/CAN 22.2 no. 601.1.

Copyright© 1998 by Medtronic, Inc. All rights reserved.

inside front cover

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Introduction

INTRODUCTION

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INTRODUCTION Autologous blood is blood that is derived from the same individual. Therefore, an autologous transfusion is one in which the patient receives only his/her own blood. Autotransfusion is a procedure in which the blood lost by or removed from a patient (autologous blood) is subsequently returned to the patient’s circulation.

Advantages of Autotransfusion over Allogeneic Transfusion Because of concern over blood-related diseases, increasing numbers of physicians and patients are focusing their attention on the risks of allogeneic transfusion, which has resulted in increased interest in autotransfusion. There are several benefits: • Hepatitis risk is eliminated, as well as other blood-transmitted diseases. • Cross-matching errors are eliminated. • Use of autologous blood provides additional assurance when performing surgery on patients with multiple red blood cell antibodies or rare blood phenotypes. • Valuable allogeneic blood is conserved.

Intended Use The autoLog™ is intended for use in the collection, concentration, washing and reinfusion of autologous blood. Such areas of application may include, but are not necessarily limited to, the following: • General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, Obstetric/Gynecologic and Neurosurgical • Postoperative treatment areas

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Principles of Operation The autoLog™ operates by separating whole blood into its individual components by centrifugation. Blood is an ideal biologic mixture for such a technique, because it is a suspension of heterogenous elements of significantly different densities and, thus, is easy to separate. When subjected to a centrifugal force, the components will migrate relative to their respective density, with the higher density components moving farther from the axis of rotation than those of lesser density. As blood continues to enter the spinning bowl, the amassing red cell pack begins to occupy more of the bowl volume and the excess plasma is pushed ahead of the red cells. When the total liquid volume of the bowl has been exceeded, the excess plasma is expressed from the bowl through the effluent fluid outlet to the waste bag via connecting tubing. To rid the red cell pack of contaminants, it is washed with isotonic saline (0.9% sodium chloride solution). At the termination of washing, the clean, packed red cells are transferred to the holding bag. This is accomplished by reversing the fluid pump rotation, which draws blood from the base of the bowl and transfers it to the holding bag via the attached tubing. The blood is transferred to a blood transfer bag and then to the patient.

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General Warnings and Precautions

WARNINGS, PRECAUTIONS, CONTRAINDICATIONS, AND POSSIBLE COMPLICATIONS

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WARNINGS, PRECAUTIONS, CONTRAINDICATIONS, AND POSSIBLE COMPLICATIONS

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READ THIS OPERATOR’S MANUAL COMPLETELY PRIOR TO USING THE AUTOLOG™

General Warnings and Precautions: 1. Direct Patient Reinfusion: Do not use the autoLog™ for direct patient reinfusion (i.e., from the machine directly into the patient) or direct patient draw (i.e., from the patient directly into the machine). Adequate safeguards do not exist to protect the patient in these situations. 2. Reinfusion of washed red cells can be carried out by gravity or pressure infusion after transferring processed blood to blood transfer bags. Do not directly reinfuse processed blood from the holding bag to the patient. Directly reinfusing the blood from the holding bag exposes the patient to the risk of possible air embolism. 3. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Actual performance results may vary depending on many in-use variables. It is important to read and understand this Operator’s Manual and understand the principles of cell washing before undertaking clinical operation of the autoLog™. The responsibility for the use of this device in all cases belongs solely to the physician ordering its use. 4. The safe operation of all cell washing equipment requires the presence of a dedicated operator. It is the responsibility of the hospital to ensure that the individuals assigned to this task are well trained in the operation of the autoLog™ and alert to potential problems. Never leave the machine unattended during operation. 5. This device is intended for autotransfusion use in clinical patient care areas, such as operating rooms, intensive care or recovery rooms. This device is NOT intended for use in blood banks or apheresis centers or for use where the blood bank has to handle, label, store, hold, or otherwise process the blood for later reinfusion into the same patient. 6. The disposable components utilized with this device are for single patient use only. Only Medtronic sterilized disposable kits are approved for patient use with the autoLog™. Maintain a sterile field at the collection site. It is important that aseptic technique be used to minimize the possibility of contamination to the disposables and/or patient. 7. Do not attempt to reuse the disposables. Reuse may adversely affect performance of this system and compromise patient safety.

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8. The disposables must be used immediately after the removal of the protective packaging. Visually inspect the contents of the disposables. Should any evidence of damage to components be found during inspection or setup, do not use the disposable. Do not use silicone oils or greases near the disposables. 9. The disposables are STERILE (Ethylene Oxide) and NON-PYROGENIC as long as package integrity has not been violated. Do not use if package is damaged or open. Store all disposables in a dry place away from extremes of temperature. 10. The autoLog™ must not be used in the presence of flammable agents. 11. The basic concept of cell washing involves the removal of the contaminated plasma and debris, while leaving red cells suspended in clean saline. Removal of large amounts of plasma during autotransfusion can cause patient hypovolemia. Since platelets and coagulation factors are contained in the plasma, this plasma removal also may reduce coagulation factors or platelet levels below normal levels. It is also possible that inadequate washing of salvaged blood may result in insufficient removal of anticoagulant and/or the development of coagulopathies upon return of that blood to the patient. Therefore, careful monitoring of the patient’s coagulation status is important to prevent complications. 12. Medtronic advises that all autologous collected blood be washed prior to reinfusion. 13. Medtronic does not have sufficient data to support the safety and efficacy of returning washed cells from partially filled bowls and, therefore, cannot recommend that practice. 14. Blood may be salvaged from body cavities, joint spaces and other operative sites or trauma sites only if there is no clinical evidence of sepsis, malignancy or wound contamination. 15. Never transfuse blood that is suspected of having high hemolysis. 16. Make sure no water or Betadine™ irrigation is aspirated into the autotransfusion system at any time, as this will hemolyze the red cells. Use an adequately sized suction tip to minimize hemolysis. 17. Vacuum levels exceeding 280 mbar (210 mmHg) may cause hemolysis. 18. Do not use any hot solutions over 42°C (108°F), since high heat can destroy red cells. 19. Do not use the autoLog™ at temperatures higher than 30°C (86°F). Operation of the autoLog™ at temperatures over 30°C (86°F) may cause overheating of the centrifuge, which could cause hemolysis. 20. Plastic materials used in the autoLog™ and its disposable kits may be sensitive to chemicals (such as solvents and certain detergents). Under certain adverse conditions, exposure to these chemicals (including vapors) may cause the plastics to fail or malfunction. 4

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21. Treat all blood and fluids using Universal Precautions (Bloodborne Pathogen Precautions). 22. In the unlikely event of a power or other failure during the wash portion of the cycle, the result will be a lower hematocrit than is normally processed. The blood should be tested for hematocrit so that the operator knows what is being given to the patient. 23. Do not restrict the flow in any tubing line. If a tubing line is inadvertently clamped or kinked during operation, pressure may build up in the centrifuge bowl causing failure or leakage. The operator should always check the entire disposable kit to confirm that all tubing is free of any kinks, twists or flat areas. Double check the pump head and wash kit to ensure that all components are in the proper flow direction. 24. The standard waste bag for the autoLog™ holds approximately 10 L of volume. The operator should periodically check the waste bag volume and empty as required. The waste bag may be emptied at any time; however, a small amount of fluid (100 – 200 ml) should be left in the bag to provide for proper expansion during filling and emptying. Avoid the introduction of room air into the waste bag. 25. The AABB Standards for Blood Banks and Transfusion Services (17th Edition, 1996) recommends the expiration period for blood collected intraoperatively to be 24 hours if stored between 1°C and 6°C, and 6 hours if stored at room temperature (section L2.600). The transfusion of shed blood collected under postoperative or posttraumatic conditions shall begin within 6 hours of initiating the collection (section L2.900). In the unlikely event of power failure, these guidelines should be strictly adhered to. Do not transfuse any blood that is older than 6 hours, either pre-processed or post-processed blood. If the blood is less than 6 hours, it is permissible to continue processing and transfuse the blood to the patient. 26. Medtronic recommends the use of a blood transfusion filter between the reinfusion container and the patient in compliance with AABB Standards, which state, “They (blood and blood components) must be transfused through a sterile, pyrogen-free transfusion set that has a filter designed to retain particles potentially harmful to the recipient” (AABB Standards for Blood Banks and Transfusion Services, 17th Edition, 1996: section J8.000). 27. Inside the autoLog™ cabinet there are various electrical components and wiring. Physical contact with any of these components while the unit is plugged in could result in severe electrical shock. Always turn off and unplug the unit prior to working inside the cabinet or changing any fuses. For continued protection against risk of fire, replace fuses only with the same type and rating. Internal grounding is provided for safety. 28. Although this system has been tested for EMC compliance and passed, the potential exists that, in some situations, the autoLog™ and other devices might electromagnetically interfere with each other. The operator should take steps that minimize this possibilty. 5

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29. The autoLog™ includes a centrifuge that rotates at 10,000 rpm. Parts that turn at high speeds may be dangerous. Safety rules related to the use of centrifuges must be followed. Do not open the centrifuge or remove the bowl before it comes to a complete stop. 30. Leakage current is a primary indicator of electrical shock hazard to personnel making contact with any exposed portion of the equipment. Each autoLog™ is checked during the final quality inspection to verify that leakage current is less than 100 µA. The owner or operator should have leakage current checked at least yearly or as required by the operating facility’s biomedical engineering department or other qualified service technician. In addition, particular attention should be given to checking the leakage current and insulation after an event such as a fluid spill or major voltage surge in the power source has occurred, or after any machine repair. 31. It is important that the autoLog™ be maintained in good working order and calibrated on a regular basis.

Contraindications and Complications: 1. The use of citrate-based anticoagulant in patients with impaired liver function may require additional monitoring and may, in certain circumstances, be contraindicated. Improperly processed red cells may contain residual citrate-based solution which, in excess quantities, could cause citrate toxicity, depression of serum calcium, or bleeding tendencies. 2. Gross contamination and/or septic procedures. 3. Surgery within the malignant area that may allow dissemination of tumor/malignant cells, if aspirated, into the autotransfusion system. 4. Caesarean sections (presence of amniotic fluid). 5. Presence of high concentrations of prostatic fluid. 6. Contamination of salvaged blood with drugs not intended for intravenous administration. Collagen-based hemostatic agents and Gel-foam™ should not be used in combination with any autotransfusion system. In their presence, temporarily discontinue salvage during the time the agent is being used. After the agent has been given time to initiate hemostasis in the wound, irrigate the area copiously with saline and aspirate to nonautotransfusion collection containers before autologous blood salvage is continued. Failure to flush the area thoroughly could result in the hemostatic agent being drawn into the collected blood. This could result in coagulation of the collection blood or possible disseminated intravascular coagulopathy (DIC) complications in the patient. 8. Coagulopathy. 7.

9. Morbidity and mortality in autotransfusion, as in allogeneic transfusions, are directly related to the volume of blood infused, if plasma and platelets are not concurrently transfused. 6

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DEVICE

AND SPECIFICATIONS

Device Description and Specifications

DESCRIPTION

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DEVICE DESCRIPTION AND SPECIFICATIONS Features and Specifications Note: Technical data, features and options referenced in this manual are based on the latest information available at the time of printing. Medtronic reserves the right to change specifications without notice. • Electrical Classification:

Class I, Type B Equipment, Ordinary, Continuous Operation

• Power: – Voltage:

110 /120 or 220 / 240 V~

– Cycles:

50 – 60 Hz

– Phase:

Single

– Current:

1.6 / 0.8 amps (depending upon voltage selection)

– Fuses:

4 AT / 240 V

– Power cord:

2 wires plus ground (earth) connector 3 prong hospital grade (USA only)

• Speed and Flow Rate Specifications: – Centrifuge:

0 – 10,000 rpm (± 5%)

– Pump:

0 – 600 ml/min (± 5%)

– Vacuum:

200–280 mBar

– Maximum reservoir bag inlet flow rate:

2.1 +/- 0.2 LPM (at -280 mbar vacuum)

• Dimensions: – Width:

33 cm (13 inches)

– Height:

75 cm (30 inches)

– Depth:

22 cm (9 inches)

• Weight:

32 kg (70 lb.)

• Temperature Limit: – Operational:

10°C – 30°C (50°F – 86°F)

– Storage:

5°C – 50°C (41°F – 122°F)

• Humidity Range: – Operational:

10 – 95 % non-condensing

– Storage:

10 – 95 % non-condensing 7

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• Sound Signals - the autoLog™ has five different sound signals: Sound Signal

Description

OK signal or Acknowledgment (2 beeps)

Signals the beginning or end of an automatic cycle or everything is normal.

Warning signal (2 series of 3 beeps)

This signal is always accompanied by a warning message. The display provides information that allows the operator to react appropriately. Afterwards, the operator will have to restart the machine by pressing the flashing key.

Machine error signal (6 beeps)

This indicates there is a machine error. In case of error, turn off the machine and then turn it back on. If the problem persists, write down the type of error and contact Technical Service.

5V supply or processor error (continuous tone)

This signals a 5V supply or processor error. Turn off the machine and then turn it back on. If the sound persists, contact Technical Service.

Power failure signal (continuous tone that fades out)

This signals a machine or supply failure. See the “Troubleshooting” section.

• Control Panel:

The control panel consists of 4 keys (each with its own green LED) and a 20 character by 2 line display.

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• GO key (green):

This key starts or resumes the process from the point where it was stopped.

• STOP key (red):

In case of emergency, press this key and the machine will stop and not restart automatically. To resume the cycle where it has stopped, press the key identified by the flashing LED or select one of the functions available in the FUNCTION mode.

• FUNCTION key:

Available only when the machine is stopped. Press the FUNCTION key several times to scroll through the various functions. To exit the FUNCTION mode, keep the key pressed for a few seconds or press the STOP key. Exit also occurs automatically after 10 seconds.

These functions allow manual transfer of the various volumes in specific circumstances as listed below: EMPTY CENTRI> RESERVOIR

Keeping the GO key pressed will force the pump to transfer the contents of the bowl back into the reservoir.

EMPTY CENTRI> HOLDING BAG

Keeping the GO key pressed will force the pump to transfer the contents of the bowl directly into the holding bag.

REMOVE AIR INVERT HOLDING BAG

Keeping the GO key pressed will force the pump to suck the air out of the holding bag if it is held upside down.

Language: To select a preferred language, turn the machine off. Then, turn it on again while simultaneously pressing the GO and STOP keys. The machine will display: CHOOSE YOUR LANGUAGE ENGLISH

Select the appropriate language by pressing the FUNCTION key.

Turn off the machine to record the language chosen. • INCREMENTATION (+) key: This key has two functions: 1. Operator Choice – Whenever a displayed request must be answered by YES or NO, this key lets the Operator toggle between YES and NO. 2. Process Acceleration – A quick double press of this key during the Wash phase also allows the Operator to jump directly to the Emptying phase.

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• autoLog™ System Components:

• Alarms: –

When an alarm condition occurs, the cause for the alarm will be shown on the display. The autoLog™ will then sound with 2 series of 3 beeps and the warning message will display, alerting the operator to the alarm situation. Alarm Text “Kit Not Installed Lock Centri Cover”

“Kit Misinstalled In Valve”

Corrective Action The wash kit is not installed or is incorrectly installed in the centrifuge. Install the wash kit or check the installation of the wash kit in the centrifuge. The wash kit is incorrectly installed. Install the kit correctly in the valve. Pressing GO will resume operation after causing the valve to rotate once.

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Alarm Text “Centri Cover Not Locked”

“Air in Reserv. Line Final Cycle? No”

Corrective Action The centrifuge cover is not properly locked into place. Lock the centrifuge cover correctly by twisting until an audible “click” is heard (the cover ears should be in front of the two arrows). The reservoir is empty, not connected properly or the collection line is obstructed. If no reply is given, the centrifuge will stop after approximately one minute. The machine will restart as soon as the reservoir is sufficiently full again. If this is the end of the blood recovery cycle, select YES with the “+” key and confirm with the GO key. If not, check the reservoir valve line and resume by pressing the GO key.

“Air In Saline Line”

The saline bag is empty, is not connected or one of the lines is obstructed. Replace the empty saline bag or check the saline valve line. Resume by pressing the GO key.

“Emptying too Short (air in line?)”

Air leaks between the bowl and air detector or in the waste bag. Check the tubing in the roller pump. Resume by pressing the GO key.

“Emptying too Long (Occlusion?)”

Obstruction in the bowl transfer line. Check the bowl – roller pump – transfer line.

“Waste Bag Full”

The waste bag is full. Empty the waste bag.

“Holding Bag is Full”

The holding bag is full. Change the holding bag.

“Optics Obstructed”

The optics in the centrifuge are dirty or obstructed. Open the centrifuge cover and clean the emitter and receptor in the centrifuge. Resume by pressing the GO key.

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• Anticipated Hematocrit:

Achievable Hematocrit (Hct - %)

70 60

56 +/- 5

58 +/- 3

20

30

39 +/- 14

50 40 30 20 10 0 10

Inlet Hematocrit (Hct - %)

The above data is from In Vitro research using bovine blood. Clinical data may vary significantly. n=6 for the 10 and 20% Hct and n=12 for the 30% Hct. Accuracy of the inlet Hct was ± 0.5%.

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