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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 C22.2 no. 601.1. autoLog® is a registered trademark of Medtronic, Inc.

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Explanation of symbols on package labeling Attention, See Instructions for Use Fuse Equipotentiality On/Off Power - Vacuum Pump Alternating Current Humidity Limitation Temperature Limitation

Do Not Resterilize Do Not Reuse Nonsterile Catalog Number Lot Number Serial Number

Date of Manufacture Use By Sterilized Using Ethylene Oxide Nonpyrogenic Fluid Path Quantity For US Audiences Only

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Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Council Directive 93/42/ EEC. autoLog Autotransfusion System Medical equipment with respect to electric shock, fire and mechanical hazards only in accordance with UL2601-1 and CAN/CSA C22.2 No. 601.1. Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product. This Way Up Keep Dry Fragile, Handle with Care Corrugated Recycles Protective Earth Ground China RoHS Standard (SJ/T11364-2006) Electric Information Products Pollution Control Symbol. The number represents the years the device can be used before it must be recycled (environmental protection use period). Contains di(2-ethylhexyl)phthalate (DEHP) Manufacturer Consult Instructions for Use Authorized Representative in the European Community

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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 Autotransfusion System is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not limited to, the following: General, cardiovascular, orthopedic, vascular, plastic/reconstructive, obstetric/gynecologic and neurosurgical surgery Postoperative treatment areas ■

■

Principles of Operation The autoLog Autotransfusion System 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 heterogeneous elements of significantly different densities and, thus, is easy to separate. When subjected to a centrifugal force, the blood components will migrate relative to their respective densities, with the higher density blood components moving farther from the axis of rotation. An itemized list of recovered and removed material is shown here: Recovered: washed, packed red blood cells ■

Removed examples include (materials less dense than red blood cells): lipids and fats plasma-free hemoglobin pharmacologic agents activated platelets irrigation solutions activated clotting factors ■ ■ ■ ■ ■ ■

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 exits 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).

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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. 4

1

2

3

Figure 1.

1. Effluent Fluid Outlet 2. Plasma 3. Red Cells 4. Whole Blood Inlet

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Warnings, Precautions, Contraindications, and Possible Complications #

Read this Operator’s Manual completely prior to using the autoLog Autotransfusion System.

Warnings and Precautions 1. Direct Patient Reinfusion: Do not use the autoLog Autotransfusion System for direct patient reinfusion (ie, from the machine directly into the patient) or direct patient draw (ie, 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 Autotransfusion System. 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 Autotransfusion System and alert to potential problems. Never leave the machine unattended during operation as irrecoverable damage to the blood may occur. 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. This disposable was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death. Only Medtronic® sterilized disposable kits are approved for patient use with the autoLog Autotransfusion System. 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 the patient. 7. Due to the presence of phthalates in the product, the clinician must weigh the medical benefits of product use against the drawbacks of phthalate exposure for male children and pregnant or nursing women. 8. Do not attempt to reuse the disposables. Reuse may adversely affect the performance of this system and compromise patient safety. 9. 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 and return to Medtronic for replacement. Do not use silicone oils or greases near the disposables.

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10.The disposables are sterile (ethylene oxide) and nonpyrogenic as long as package integrity has not been violated. Do not use if the package is damaged or open. Store all disposables in a dry place away from extremes of temperature. 11. The autoLog Autotransfusion System must not be used in the presence of flammable agents. 12.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 may also 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. 13.Medtronic advises that all autologous collected blood be washed prior to reinfusion. 14.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. 15.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. 16.Never transfuse blood that is suspected of having high hemolysis. 17.Make sure no water or other irrigation, such as Betadine®1, 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. 18.When using a hard-shell cardiotomy or blood collection reservoir, vacuum levels should not exceed 150 mm Hg. 19.Do not use any hot solutions over 42°C (108°F), since high heat can destroy red cells. 20.To avoid overheating the centrifuge, which could cause hemolysis, do not use the autoLog Autotransfusion System at temperatures higher than 30°C (86°F). 21.Plastic materials used in the autoLog Autotransfusion System 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. 22.Treat all blood and fluids using universal bloodborne pathogen precautions. 23.In the unlikely event of a power loss or other failure during the wash portion of the cycle, a lower than normal hematocrit will result. The blood should be tested for hematocrit so that the operator knows what is being given to the patient. 24.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. 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. 25.The standard waste bag for the autoLog Autotransfusion System holds approximately 10 L. 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. A full waste bag will cause back pressure and bowl leaks to occur. 1

Betadine® is a registered trademark of Purdue Frederick Company.

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26.The AABB Standards for Perioperative Blood Collection and Administration (Third Edition, 2007), Reference Standard 5.1.8A, recommends the expiration period for blood recovered interoperatively with processing be stored at room temperature no longer than 4 hours from the time of collection. Interoperative blood collected with processing can be stored for 24 hours at 1°C and 6°C, if the storage is begun within 4 hours of completion of processing. The transfusion of shed blood collected under postoperative or post-traumatic conditions shall begin within 6 hours of initiating the collection. In the unlikely event of power failure, these guidelines should be strictly adhered to. If the blood is less than 4 hours old, it is permissible to continue processing and transfuse the blood to the patient. 27.Medtronic recommends the use of a blood transfusion filter between the reinfusion container and the patient in compliance with The AABB Standards for Perioperative Blood Collection and Administration (Third Edition, 2007), Reference Standard 5.4.5.1, which states, “Perioperative products intended for transfusion shall be transfused through a filter designed to retain particles that are potentially harmful to the patient.” 28.Inside the autoLog Autotransfusion System 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. 29.Although this system was tested for EMC compliance and passed, the potential exists that, in some situations, the autoLog Autotransfusion System and other devices might electromagnetically interfere with each other. Take steps to minimize this possibility. 30.The autoLog Autotransfusion System 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. 31.Current leakage is a primary indicator of electrical shock hazard to personnel making contact with any exposed portion of the equipment. Each autoLog Autotransfusion System is checked during the final quality inspection to verify that current leakage is less than 100 µA. Have current leakage 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 current leakage 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. 32.Maintain the autoLog Autotransfusion System in good working order and calibrate it on a regular basis.

Transportation of Device 1. To avoid potential damage during transit, use the autoLog Autotransfusion System’s original shipping packaging. 2. Never lay the autoLog Autotransfusion System on its side as this can damage the centrifuge. 3. Be careful not to move the autoLog Autotransfusion System by the IV pole. Over time this can cause the top panel of the machine to loosen and cause permanent damage.

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.

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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. 7. Collagen-based hemostatic agents, such as Gelfoam®2, 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 non-autotransfusion 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. 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.

2

Gelfoam® is a registered trademark of Pharmacia & Upjohn Company.

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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, Ordinary, Continuous Operation Power: Voltage:

110 – 120 / 220 – 240 V~

Frequency:

50 – 60 Hz

Phase:

Single

Current:

1.6 / 0.8 A (depending upon voltage selection)

Fuses:

4 A / 250 V~ / T

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:

150 – 200 mm Hg

Dimensions: Width:

33 cm (13 in)

Height:

75 cm (30 in)

Depth:

22 cm (9 in)

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% noncondensing

Storage:

10 – 95% noncondensing

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Sound Signals-the autoLog Autotransfusion System 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 on the display. After taking appropriate action, restart the machine by pressing the flashing key.

Machine error signal (6 beeps)

Indicates a machine error. Turn off the machine and then turn it back on. If the problem persists, write down the error type and contact Technical Service.

5V supply or processor error (continuous tone)

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)

Signals a machine or supply failure. See the Troubleshooting section.

Control Panel:

3

1

4

2

5

6

Figure 2.

1. Go key (green): This key starts or resumes the process from the point where it was stopped. 2. Stop key (red): In case of emergency during the fill and wash cycles, press this key; the machine will stop and automatically return the contents of the bowl to the collection reservoir. The autoLog Autotransfusion System will not automatically restart. 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. 3. Control display panel: 20-character, 2-line display. 4. Control panel: The control panel consists of 4 keys (each with its own green LED).

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5. 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

Keep the Go key pressed to force the pump to transfer the contents of the bowl back into the reservoir.

EMPTY CENTRI> HOLDING BAG

Keep the Go key pressed to force the pump to transfer the contents of the bowl directly into the holding bag.

REMOVE AIR INVERT HOLDING BAG

Keep the Go key pressed to force the pump to suck the air out of the inverted holding bag.

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 the machine off to record the language chosen. 6. Incrementation (+) key: This key has two functions: 1. Operator Choice – Toggles between YES and NO whenever a displayed request must be answered. 2. Process Acceleration – Quickly press this key twice during the wash phase to jump directly to the emptying phase.

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autoLog Autotransfusion System Components: 12

5

6

13

4

3

2

21 9

19 10

1 8

18 16

11

15 17

20

14 7

Figure 3.

1. Air Detector Guide

12. IV Pole Lock Bolt

2. Centrifuge Chamber

13. IV Pole Mast

3. Centrifuge Notches

14. Power Switch

4. Clamp Valve Cover

15. Pump Head

5. Clamp Valve Head

16. Pump Lever

6. Clamp Valve Lever

17. Pump Lever Groove

7. Control Display Panel

18. Pump Outlet Tubing Guide

8. Function Key

19. Stop Key

9. Go Key

20. Vacuum Switch

10. Hardshell Bracket

21. Waste Bag Holding Pins

11. Incrementation (+) Key

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Alarms: When an alarm condition occurs, the cause for the alarm appears on the display. The autoLog Autotransfusion System then sounds 2 series of 3 beeps and the warning message displays.

Alarm Text

Corrective Action

Kit Not Installed Lock Centri Cover

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.

Kit Misinstalled In Valve The wash kit is incorrectly installed. Install the kit correctly in the valve. Press Go to resume operation after causing the valve to rotate once. Centri Cover Not Locked

The centrifuge cover is not properly locked into place. Lock the centrifuge cover correctly by twisting until an audible click is heard (the wings should be in front of the two arrows).

Air in Reserv. Line Final The reservoir is empty, not connected properly, or the collection line is Cycle? No obstructed. If no reply is given, the centrifuge stops after approximately one minute and automatically returns the bowl’s contents to the reservoir. The machine restarts 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.

Empty too Short (air in line?)

There are 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.

Empty too Long (Occlusion?)

There is an 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 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 with deionized water. Resume by pressing the Go key.

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In Vitro Specifications – Anticipated Hematocrit

70 –

Achievable Hematocrit (HCT - %)

60 –

56 ± 5

58 ± 3

20

30

39 ± 14 50 – 40 – 30 – 20 – 10 – 0 10

Inlet Hematocrit (HCT - %) Figure 4.

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

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Operation Supplies Required ■

■ ■ ■ ■ ■

Wash Kit, which includes: – Centrifuge bowl (135 mL capacity) with tubing – Holding bag (1000 mL capacity) – Waste bag (10 L capacity) Blood collection reservoir Adequate quantity of 0.9% normal saline for washing Adequate quantity of anticoagulant solution Blood transfer bags Suction/anticoagulant line

Setup: Blood Collection System 1. Ensure that the power is off. 2. Open the sterile hardshell reservoir and remove the step down connector. 3. Attach the sterile step down connector to the bottom of the reservoir and clamp. 4. Place the reservoir in the holder. Attach the vacuum line to the yellow capped port. 5. Attach the other end of the vacuum line to the regulated vacuum source (VR702). 6. Ensure the regulated vacuum source is attached to the vacuum port on the cabinet. 7. Open the suction/anticoagulant line pouch and aseptically pass that line to the sterile field. Aseptically pass the blue end of the suction/anticoagulant line to the operator and attach the blue capped straight end to either the blue or white capped port on top of the reservoir. 8. Close the clamp on the anticoagulant IV drip line. If the anticoagulant solution is non-vented, open the vent cap on the drip chamber. 9. Plug the autoLog Autotransfusion System into a power outlet. 10.Turn on by pressing the power switch followed by the vacuum switch. The unit will power up, do a quick self-test, and display “AUTOLOG VERSION XX.X.” If no kit is installed, the machine will display “KIT NOT INSTALLED: LOCK CENTRI COVER.” 11. Set the vacuum regulator gauge to approximately 120 mm Hg. Do not set it higher than 200 mm Hg. 12.Spike the anticoagulant solution. Open the clamp and prime the reservoir with a minimum of 100-200 mL of anticoagulant solution. Reduce the anticoagulant flow to a ratio of approximately 15 mL of solution/100 mL blood. Monitor collection reservoir periodically for appropriate anticoagulation. 13.If the blood collection will not start within 5–10 minutes, the anticoagulant flow may be stopped. Be sure to restart the anticoagulant solution prior to the collection of blood. 14.Blood collection may now begin.

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8

6

1

12 3 10

2 13

7 14

5

9

11

4

Figure 5.

1. Anticoagulant Solution

8. Saline Bag

2. Blood Source

9. Step Down Connector

3. Collection Reservoir

10. Suction/Anticoagulant Line

4. From Collection Source

11. To Holding Bag

5. From Saline Bag

12. To Vacuum Regulator

6. Holding Bag

13. Vacuum Switch

7. Power Switch

14. Waste Bag

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Setup: Centrifuge Bowl and Tubing Harness 1. Hang the saline wash solution on the lower IV pole hanger. This must be either a minimum of a 2-liter bag or two 1-liter bags. 2. Open the wash kit, remove the holding bag, and hang it on the upper IV pole hanger. Close any clamps. 3. Remove the waste bag from the wash kit, verify that the drain valve is closed, and install the waste bag on the posts provided at the side of the autoLog Autotransfusion System (volume markers facing away from the machine). 4. Make sure no dust, dirt, or other foreign material is in the centrifuge chamber or in the air detector tubing guide. If needed, clean (see the Calibration, Cleaning, and Maintenance section). If it is not clean, the bowl may not seat properly and vibration may result, or the air detector may not function properly. 5. Place the bowl into the chamber with the side tubing facing the waste bag. Align the centrifuge notches with the openings on the wings of the centrifuge bowl. Press down and turn clockwise to lock the bowl in place (you should hear an audible snap). If the machine is on, it will display “INSERT KIT IN VALVE AND PUMP.” Make sure that the bowl is completely inserted. Remove, clean, and reinsert if necessary. 6. Connect the side (waste) tubing to the waste bag. Confirm that there are no kinks in the tubing. Use the red stripe as an indicator that no kinks have occurred. 7. Place the manifold into the opening between the lever and the valve head with the three tubes toward the back of the machine, and the bevel on top. Once the manifold is correctly inserted, release the valve lever to complete the installation. Each of the three tubes should be in its own guide and the manifold should be partially covered by the valve lever. Confirm that there are no kinks in the tubing. Correct if necessary. 8. While holding the machine firmly, place your thumb into the pump lever groove and open the pump lever in the direction of the arrow. Be careful not to pinch your fingers in the pump lever. 9. Place the pump header tubing into the space between the pump head and the pump lever. Stretch the tubing over the pump outlet tubing guide and into the groove to engage the pump header positioner in the socket. Make sure no kinks or twists have occurred using the red stripe as an indicator. Once the tubing is correctly inserted, release the pump lever to complete the installation. 10.Insert the pump header tubing into the air detector guide. Use the blue tubing insertion tool only, as other instruments can damage the air detector. It is important to fully insert the tubing into the guide. 11. Press the Go key. The machine will perform a complete rotation of the valve head. The machine will display “CONNECT SAL, HOLDING, RESERVOIR AND WASTE.” 12.Verify the connection of the kit to the holding bag. 13.Spike the middle manifold tubing into the saline bag. Release the saline clamp. 14.Connect the bottom manifold tubing to the step down connector on the bottom of the reservoir. 15.Setup of the disposable components is now complete. Press Go to confirm completion. The machine will prime the system with a small amount of saline and place the machine into standby. The display will read: “STOP 0 mL 0 mL.” In the standby mode, the machine will not start automatically.

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10:37 am

6 x 8.5 inches (152.4mm x 215.9mm)

Operation 1. To move the machine out of standby mode and into automatic mode, press the Go key. The display will read: “MACHINE READY 0 mL 0 mL.” Manual: To manually start processing, press the Go key a second time. Automatic: In this mode, the machine will begin processing the blood once the volume in the reservoir reaches approximately 800 mL. 2. If the blood volume in the reservoir remains sufficient, the machine will automatically complete a minimum of seven wash cycles. 3. Each wash cycle consists of the following phases: Phase

Sample Display Message

Description

Idle

MACHINE READY 0 mL 0 mL

The LED of the Go key flashes. The machine is waiting for automatic start or the Go key to be pressed.

Filling

INPUT 32 mL

TRANSFERRED 0 mL

The centrifuge and pump rotate and the bowl fills at a rate of approximately 600 mL/min. Once the level sensor initially detects that the bowl is full and the input volume is greater than 225 mL, the second fill cycle drops to approximately 250 mL/min. If the initial input volume is 225 mL or less, the second fill cycle remains at approximately 600 mL/ min (fast second fill).

Wash

WASH TRANSFERRED 105/250 mL 0 mL

The wash phase starts as soon as the level sensor detects a full bowl at 250 mL/min. The display shows the volume of wash saline used / total saline volume needed. The wash phase can also be aborted manually by pressing the Incrementation (+) key twice.

Emptying

INPUT 1250 mL

TRANSFERRED 0 mL

As soon as the full wash volume has been processed and the centrifuge has come to a complete halt, the pump transfers the washed and concentrated cells to the holding bag. The display shows the total transferred volume as it is pumping.

Post-cycle

INPUT 1340 mL

TRANSFERRED 0 mL

The total volume transferred is displayed. If the volume in the reservoir is sufficient, another wash cycle will start. If the volume is inadequate, the machine will return to the MACHINE READY state. The machine will automatically start when sufficient volume is in the reservoir. When the machine has filled the holding bag to capacity (approximately 979 mL), a message prompts you to change the bag. After changing to a new holding bag, you may start another series of cycles by pressing the Go key, thereby placing the machine in the MACHINE READY state.

4. Final Cycle/Return Function: The machine will stop during a fill phase due to lack of blood in the reservoir. When this happens, there are three options: ■ Do Nothing - The centrifuge will continue to rotate for one minute, then stop. The contents of the bowl will be returned to the reservoir and the machine will start again when the blood volume is sufficient. OR ■ Continue Normally - This option is usually used to restart when air is falsely detected. When the Go key is pressed, a normal cycle fill phase is attempted. OR

Operator’s Manual

M938156A001 Rev 1.0

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