autoLog IQ™
0123
Autotransfusion System
User Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective
owners.
autoLog IQ, Medtronic
Contents
1 Explanation of packaging, labeling, and device symbols ..................................... 5
2 Introduction .................................................................. 7
2.1 Advantages of autotransfusion over allogeneic transfusion ...................................... 7
2.2 Principles of operation ........................................................... 8
3 Intended use .................................................................. 9
4 Contraindications .............................................................. 9
5 Warnings and precautions ......................................................... 9
6 Adverse effects ............................................................... 11
7 Device description ............................................................. 11
7.1 Device components ............................................................ 11
7.2 Items included with the device ...................................................... 17
7.3 Optional items not included with the device .............................................. 17
7.4 Audible alert signals ............................................................ 17
7.5 Visual alert signals ............................................................. 17
8 In vitro performance ............................................................ 18
9 Transportation and storage ....................................................... 18
9.1 Transporting the device .......................................................... 18
9.2 Transporting the device between clinical sites ............................................ 18
9.3 Storing the device ............................................................. 18
10 Setting up the optional barcode scanner .............................................. 19
11 Turning on the device power ...................................................... 19
11.1 Connecting the device power cord .................................................. 19
11.2 Turning on the device power ...................................................... 19
12 Managing device settings ....................................................... 20
12.1 Settings screen .............................................................. 20
12.2 Setting the time .............................................................. 20
12.3 Setting the alert theme ......................................................... 21
12.4 Initial password setup .......................................................... 21
12.5 Updating or resetting the password .................................................. 22
12.6 Main screen overview .......................................................... 22
12.7 Function capabilities ........................................................... 23
13 Operating the device ........................................................... 24
13.1 Supplies required ............................................................. 24
13.2 Entering case data ............................................................ 24
13.3 Setting up the device for blood collection ............................................... 25
13.4 Setting up the wash kit .......................................................... 27
13.5 Initiating blood processing ....................................................... 29
13.6 Resuming a case ............................................................. 30
14 Managing case data ........................................................... 30
14.1 Viewing case data ............................................................ 30
14.2 Searching and filtering case data ................................................... 31
14.3 Exporting case data to a USB flash drive ............................................... 32
14.4 Exporting case data to an external device .............................................. 33
14.5 Deleting case data ............................................................ 34
15 Ending a case ............................................................... 34
16 Cleaning the device ........................................................... 34
17 Special blood processing conditions ................................................ 36
17.1 Emergency setup using multiple suction/anticoagulant lines on 1 reservoir .......................... 36
17.2 Using 2 reservoirs in series ....................................................... 37
17.3 Using 2 reservoirs in parallel ...................................................... 39
17.4 Draining cardiopulmonary bypass circuit (CPB) contents to the device ............................. 40
17.5 Postoperative wound drainage ..................................................... 40
18 Troubleshooting guide ......................................................... 40
18.1 Power failure ............................................................... 40
18.2 Unusual behavior of the device .................................................... 41
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18.3 Normal startup prompts, audible and visual alert signals ..................................... 41
18.4 Normal operating prompts, audible and visual alert signals .................................... 42
18.5 Error prompts, audible and visual alert signals ........................................... 46
18.6 Irrecoverable errors, audible and visual alert signals ........................................ 46
19 Service and maintenance ....................................................... 47
19.1 Service interval .............................................................. 47
19.2 Pump head ................................................................ 47
19.3 Service and maintenance screens .................................................. 47
19.4 Notifications ................................................................ 48
19.5 System information ............................................................ 49
19.6 Error log .................................................................. 49
19.7 Calibrate touchscreen .......................................................... 49
19.8 Clean centrifuge ............................................................. 49
19.9 Update software ............................................................. 49
19.10 Export service information ....................................................... 49
20 Device disposal and ownership transfer .............................................. 50
20.1 Deleting case data ............................................................ 50
20.2 End of life disposition .......................................................... 50
21 Specifications ............................................................... 50
21.1 Technical specifications ......................................................... 50
21.2 Electromagnetic compatibility declaration .............................................. 50
22 Warranties ................................................................. 52
22.1 Equipment limited warranty for US customers ............................................ 52
22.2 Equipment limited warranty for customers outside the US ..................................... 53
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1 Explanation of packaging, labeling, and device symbols
Caution
Fuse
Equipotentiality
Ground
Power
Stop
Vacuum pump power
Alternating current
Humidity limitation
Temperature limit
Consult instructions for use
Consult accompanying documents
Do not resterilize
Do not reuse
Do not use if package is damaged
Nonsterile
Catalog number
5
Lot number
Serial number
Manufacturer
Date of manufacture
Use-by date
Sterilized using ethylene oxide
Nonpyrogenic fluid path
Quantity
For US audiences only
Conformité Européenne (European Conformity). This symbol means that the
device fully complies with applicable European Union Acts.
Medical equipment with respect to electric shock, fire, and mechanical hazards only in accordance with ANSI/AAMI ES60601-1 (2012), CAN/CSA
C22.2 No. 60601-1 (2014) E352357.
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
Manufactured in
Corrugated recycles
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Protective earth ground
Atmospheric pressure limitation
China RoHS standard (SJ/T11364-2006)
Contains di(2-ethylhexyl)phthalate (DEHP)
Authorized representative in the European Community
Heavy
Do not push by the IV pole
Storage temperature limit
Transit temperature limit
Storage humidity limitation
Transit humidity limitation
Storage atmospheric pressure limitation
Transit atmospheric pressure limitation
Type BF applied part
2 Introduction
Autotransfusion is a procedure in which the blood lost by, or removed from, a patient (autologous blood) is subsequently returned
to the patient.
2.1 Advantages of autotransfusion over allogeneic transfusion
There are several benefits to autotransfusion:
• The risk of blood-transmitted diseases is eliminated.
• The related costs of transfusion are minimized.
• The risk of clerical errors is minimized.
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• The use of autologous blood provides additional assurance during surgery on patients with multiple red blood cell antibodies
or rare blood phenotypes.
• Valuable allogeneic blood is conserved.
• This process is generally accepted by patients with religious objections to allogeneic transfusion.
2.2 Principles of operation
Blood contains a suspension of formed elements of different densities. The autoLog IQ autotransfusion system (the device)
operates by separating whole blood into its individual components by centrifugation.
During operation, the following materials are recovered:
• Washed, packed red blood cells
• A small volume of saline
The following materials are less dense than red blood cells; they are removed during operation:
• Lipids and fats
• Plasma-free hemoglobin
• Pharmacologic agents
• Irrigation solutions
• Anticoagulants
• Potassium
• Plasma
• Saline
As blood continues to enter the spinning bowl, the amassing red blood cell pack begins to occupy more of the bowl volume, and the
excess plasma is pushed ahead of the red blood cells. When the total liquid volume of the bowl has been exceeded, the excess
plasma exits the bowl through the effluent outlet to the waste bag via the connecting tubing.
To rid the red blood cell pack of contaminants, it is washed with isotonic saline (0.9% sodium chloride solution).
Note: Trace amounts of red blood cell contamination may cause the effluent to have a slightly reddish tint.
After washing, the clean, packed red blood cells are pumped from the bottom of the bowl to the holding bag, via the attached tubing.
The blood should be transferred to a blood transfer bag and then to the patient.
Figure 1. Whole blood separation
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1 Whole blood inlet
2 Effluent outlet
3 Plasma
4 Red blood cells
3 Intended use
The autoLog IQ autotransfusion system and Medtronic wash kit are intended for use in the collection, concentration, washing, and
reinfusion of autologous blood. Areas of application may include, but are not limited to, the following:
• Surgeries including general, cardiovascular, orthopedic, vascular, plastic/reconstructive, obstetric/gynecologic, and
neurological
• Postoperative treatment areas
4 Contraindications
The process of blood recovery is associated with few complications. The surgical team must consider the risks and relative
contraindications of autotransfusion in any surgical procedure before proceeding with autotransfusion.
5 Warnings and precautions
• Read this user manual before using the device.
• Do not use the device for direct patient reinfusion (from the device directly into the patient). Adequate safeguards do not exist
to protect the patient in this situation.
• Reinfusion of washed red blood 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 air embolism. If a direct patient connection is required, follow the guidance
for detecting and preventing air embolism in accordance with the current version of AABB Standards for Perioperative
Autologous Blood Collection and Administration.
• Actual performance results may vary depending on many in-use variables. It is important to read and understand this user
manual and understand the principles of cell washing before using the device for clinical operation. The responsibility for the use
of this device in all cases belongs solely to the physician ordering its use.
• Failure to follow instructions may result in blood spillage, biohazard risk, slip hazard, low blood quality, infection, and hemolysis.
• Treat all blood and fluids in accordance with universal bloodborne pathogen precautions.
• AABB Standards for Perioperative Autologous Blood Collection and Administration recommends the expiration period for blood
recovered intraoperatively, processed, and stored at room temperature, be no longer than 8 hours from the completion of
processing. Intraoperative blood collected with processing can be stored for 24 hours between 1°C and 6°C (34°F and 43°F),
if the storage begins within 8 hours of completing processing. The transfusion of blood collected and processed under
postoperative or posttraumatic conditions must begin within 8 hours of initiating the collection. Refer to the current version
of AABB Standards for Perioperative Autologous Blood Collection and Administration for more information.
• Medtronic recommends the use of a blood transfusion filter, designed to retain particles that are potentially harmful to the
patient, between the reinfusion container and the patient, in accordance with the current version of AABB Standards for
Perioperative Autologous Blood Collection and Administration.
• Tandem collection reservoirs and leukocyte filtration can be used in relatively contraindicated cases; refer to the current version
of AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma for more information.
• For orthopedic cases, always agitate the reservoir before processing the first cycle.
• Do not leave the device unmonitored, as it could present a biohazard risk if the waste or holding bag overflows, or could result
in the loss of salvageable blood, among other concerns. It is the responsibility of the hospital to ensure that the individuals
assigned to operate this device are well trained in the operation of the device and alert to potential problems.
• This device is intended for autotransfusion use in clinical patient care areas such as operating rooms, intensive care, and
recovery rooms.
• Failure to use aseptic technique increases the risk of contaminating the disposables and harming the patient.
• Carefully monitor the patient’s anticoagulation status in order to prevent complications. The basic concept of cell washing
involves the removal of contaminated plasma and debris, while leaving red blood cells suspended in 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 or the development of
coagulopathies upon the return of that blood to the patient.
• All autologous collected blood should be washed prior to reinfusion.
• Blood may be salvaged from body cavities, joint spaces, and other operative or trauma sites. If there is clinical evidence of
sepsis, malignancy, or wound contamination, use tandem blood collection reservoirs and leukocyte filtration in accordance with
the current version of AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma.
• Never transfuse blood that is suspected of having high hemolysis.
• Only use isotonic solutions that are labeled for intravenous use, such as 0.9% saline.
• To avoid hemolytic and subhemolytic stress and subsequent red blood cell lysis, vacuum pressure should be regulated at
−80 mmHg to −120 mmHg, which is adequate for most surgical procedures. The vacuum setting may be temporarily increased
to clear the field in the event of massive blood loss, then reduced to a lower setting; refer to the current version of AABB
Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma for more information.
• Applicable to products with phthalates identified on the product label: This product contains phthalates.
• Only use Medtronic wash kits and blood collection reservoirs with the device.
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• The disposables are sterile and nonpyrogenic as long as package integrity has not been violated. Do not use the disposables
if the package is damaged or open. Store all disposables in a dry place away from extreme temperatures.
• The disposable components utilized with this device are single use only. Do not reuse, reprocess, or resterilize the disposable
components. Reuse, reprocessing, or resterilization may compromise the structural integrity of the disposables or create a risk
of contamination of the disposables, which could result in patient injury, illness, or death. Only Medtronic sterilized disposable
kits are approved for patient use with the device. Maintain a sterile field at the collection site. Use aseptic technique to minimize
the possibility of contamination of the disposable components or the patient.
• The disposables must be used immediately after the removal of the protective packaging. Visually inspect the disposables. If
any evidence of damage to the disposables is found during inspection or setup, do not use the disposable; return it to Medtronic
for replacement. Do not use silicone, oils, or greases near the disposables.
• Dispose of the disposables in accordance with local hospital, administrative, and other government policies.
• Inspect the device and included items for shipping damage upon unboxing them. Confirm that all items are included in the box
(Section 7.2). Contact your Medtronic service representative if damage is observed, or if an item is missing.
• Failure to fully secure connectors can lead to blood leakage.
• Close all clamps and use caution if transferring the disposables to a new device.
• The device must not be used in the presence of flammable anesthetic agents.
• Do not touch the bowl while it is spinning. Touching the moving bowl can lead to injury.
• Do not place items on the reservoir holder or collection reservoir.
• If using the rear reservoir holder, self-start will not be enabled, which could result in fluid overflowing the reservoir. Reservoir
overflow could cause blood spillage, biohazard risk, and slip hazard.
• Do not use any solutions hotter than 42°C (108°F), because high heat can result in crenation and can destroy red blood cells.
• To avoid overheating the centrifuge, which could cause hemolysis and crenation, do not use the device at temperatures higher
than 30°C (86°F).
• Do not use the device at temperatures lower than 15°C (59°F).
• Plastic materials used in the device and its disposable components may be sensitive to chemicals and certain detergents.
Under certain adverse conditions, exposure to these chemicals (including vapors) can cause the plastics to fail or malfunction.
• Power loss or other failure during the Fill and Wash cycles may result in lower than normal blood quality parameters. Test the
blood for hematocrit and contaminant removal to confirm suitability for patient infusion.
• Setting the vacuum at higher than desired settings, or unintentionally selecting Max vacuum, could result in hemolysis and
tissue damage.
• 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 examine the entire disposable kit to confirm that all tubing is free of
any kinks, twists, or flat areas. Examine the pump head and wash kit to confirm that all components are placed in the proper flow
direction.
• The standard waste bag for the device holds approximately 10 L. Check the waste bag volume periodically and empty as
required. The waste bag may be emptied at any time; however, 100 mL to 200 mL of fluid should be left in the bag to provide for
proper expansion during filling and emptying. A full waste bag will cause back pressure, which may cause bowl leaks to occur.
• The device includes a centrifuge that rotates at 10,000 rpm. Parts that turn at high speeds may be dangerous. Follow safety rules
related to the use of centrifuges. Do not open the centrifuge or remove the bowl before the centrifuge has completely stopped.
• Failure to respond to unusual behavior of the device could result in blood contamination or spillage.
• Choosing to wash a partially filled bowl may result in low blood quality and low red cell volume.
• Do not invert the bowl when examining for clots, as this could lead to fluid leakage.
• Do not service the device or update the device’s software during use.
• Do not move the device by holding the IV pole, as this action could damage the device or cause tipping.
• Use caution when transporting the device by vehicle. Do not expose the device to extremes of temperature, shock, or vibration.
• Do not modify the device.
• Contact your Medtronic service representative, or a biomedical equipment technician trained and certified by Medtronic, to
perform preventative maintenance and calibration of the device. Preventative maintenance and calibration should be performed
on an annual basis. Blood spillage, biohazard risk, low blood quality, slip hazard, and other concerns, could result if preventative
maintenance and calibration are not performed.
• Always turn off and unplug the device prior to working inside the cabinet or changing any fuses. Inside the cabinet are various
electrical components and wiring. Physical contact with any of these components while the device is plugged in could result in
severe electrical shock. For continued protection against risk of fire, replace fuses only with the same type and rating. Fuses
should be replaced by a Medtronic service representative or Medtronic-trained and certified biomedical equipment technician.
Internal grounding is provided for safety.
• Enclosure current leakage is a primary indicator of electrical shock hazard to personnel making contact with any exposed
portion of the equipment. Each device is tested during the final quality inspection to verify enclosure current leakage is less than
100 µA (under normal operating conditions) and less than 300 µA (under single-fault conditions). Ensure that the current
leakage is tested at least once a year, or more frequently as required, by the operating facility’s biomedical engineering
department or other qualified service technician. In addition, always test the enclosure current leakage and insulation after an
event such as a fluid spill, after a major voltage surge in the power source has occurred, or after any device repair.
• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with a protective earth ground.
• The power cord may be used to disconnect the device from electrical power. Position the device and power cord so that the
power cord can easily be accessed and disconnected.
• Although this device has been verified for EMC compliance, the potential exists that, in some situations, this device and other
devices might electromagnetically interfere with each other. Take steps to minimize this possibility.
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• The device should only be used in a hospital environment away from sources of high intensity EM disturbances, such as MRI
devices.
• The emissions characteristics of this device make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is
used in a residential environment (for which CISPR 11 class B is normally required) this device might not offer adequate
protection to radio frequency communication services. The user might need to take mitigation measures, such as relocating or
reorienting the device.
• Do not stack or attach additional instrumentation to the device to minimize the potential for RF interference.
• Use of this device with accessories, transducers, and cables other than those specified or provided by the manufacturer of this
device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in
improper operation.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used
no closer than 30 cm (12 in) to any part of the device, including cables specified by the manufacturer. Otherwise, degradation
of the performance of this device could result.
• Power cord and USB cable length must not exceed 3 m (118 in).
• Do not touch a USB port and the patient at the same time.
• Use only a USB flash drive provided by Medtronic.
• Use appropriate personal protective equipment such as eye protection, mask, and gloves when cleaning the device and
discarding used fluids. Failure to do so could result in exposure to bloodborne pathogens, blood, and cleaning fluids.
• While cleaning the centrifuge, failure to correctly install the tray for fluid collection will lead to spillage.
• While cleaning the centrifuge, failure to add sufficient volume of a 10% bleach solution or equivalent disinfectant solution for a
sufficient duration can lead to ineffective cleaning.
• Do not use bleach to clean the touchscreen, as this could discolor the screen and result in failure.
• If it is suspected that fluid has entered the device, it should be immediately examined by a trained technician. Fluid ingress could
result in electric shock to the user.
• Clean and maintain the device in accordance with this manual and hospital procedures.
6 Adverse effects
Proper or improper use of a cell salvage device can lead to the following risks to the patient and user:
Patient:
• Death
• Excessive bleeding
• Hemolysis
• Impaired liver function
• Loss of salvageable blood
• Infection
• Renal insufficiency and failure
• Low hematocrit
• Elevated serum lactate dehydrogenase levels
• Elevated total serum bilirubin levels
• Air emboli
• Febrile reaction
• Hypotension
• Increase in pulmonary and systemic vascular resistance
• Dyspnea
• Increased clotting
• Thromboembolism
• Tissue damage
• Arrhythmia
• Micro-shock
User:
• Exposure to biological fluids
• Biohazard
• Chemical exposure
• Burn injury
• Mechanical injury
• Electrical shock
• Slipping
7 Device description
7.1 Device components
The following figures detail the components of the device:
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Figure 2. Device controls
1 Power: Turns the device power on and off
2 Power LED: Illuminates when the device power is on
3 Vacuum: Turns the device’s internal vacuum on and off
4 Vacuum LED: Illuminates when the device’s internal vacuum is on
5 Stop: Stops the blood processing sequence and returns blood to the reservoir
6 Alert light: Illuminates when a prompt is displayed on the touchscreen (for more information regarding visual alert signals, see
Section 7.5)
Figure 3. Top panel
1 Centrifuge chamber (level sensor not shown)
2 IV pole collar
3 IV pole knob
4 Centrifuge notches
5 Touchscreen
6 Removable storage tray
7 Pump lever
8 Pump outlet tubing guide
9 Pump head
10 Pump tubing channel
11 Manifold cover latch
12 Manifold cover
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Figure 4. Top panel with manifold cover open
1 Air detector
2 Tubing guides
3 Manifold valve
Figure 5. Front panel
4 Manifold cover locking sensor
5 Manifold sensor
6 Recessed cavity
1 Reservoir weight sensor (enables self-start mode)
2 Reservoir holder
3 IV pole
4 Wash kit cradle arm
5 Speaker (under top panel)
6 Internal storage compartment
7 Device base
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Note: The internal storage compartment can be used to store additional disposables and solutions as needed. Use caution when
opening and closing the compartment, and while moving items to and from the compartment.
Figure 6. Back panel
1 Manifold valve cavity fluid drain
2 Vacuum overflow trap quick-disconnect
3 Vacuum overflow trap
4 Wash kit storage brackets
5 Power cord wrap
6 Wheel lock (4)
7 Equipotential connector
8 Power inlet module
9 Power cord retainer clip
10 Locking wheels (4)
11 Rear reservoir holder mounting base
12 Handle
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Figure 7. Handle positions
1 Upper storage position
2 Push position
3 Handle release button
4 Lower storage position
Note: Push the handle release button to move the handle into each position.
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Figure 8. Left panel
1 Accessory USB ports (type A)
2 Barcode scanner holster (optional)
Figure 9. Right panel
3 Barcode scanner cord retainer clip
4 Barcode scanner (optional)
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1 Waste bag pins
2 Wash kit storage holders
Figure 10. Bottom panel
3 USB port (type B)
4 Accessory USB port (type A)
1 Wash kit tray holder
2 Centrifuge drain (1/4-18 NPT)
3 Fan
4 Vacuum pump outlet
7.2 Items included with the device
The following items are included with the device:
• IV pole
• Reservoir holder
• Quick setup guide
• Quick setup video
• User manual
• Power cord
• USB flash drive
7.3 Optional items not included with the device
The following items are sold separately:
• Barcode scanner (used to simplify data entry; Chapter 10)
• Reservoir holder (attaches to the device rear reservoir holder mounting base; Figure 6)
• Medtronic cardiotomy reservoir holder E302 (attaches to an external IV pole)
Warning: Do not attach a reservoir to the device IV pole using a reservoir holder such as the Medtronic E302. The weight of a
filled reservoir attached to the device IV pole may cause tipping.
7.4 Audible alert signals
The device emits an audible alert signal when a prompt appears on the touchscreen. Audible alert signals are divided into 3
categories: notify alert, low alert, and medium alert; all require a response. See Section 13.4, Chapter 18, and Section 19.4 for the
full list of prompts and corresponding audible alert signals.
• Notify alert: 2 beeps
• Low alert: 2 beeps, repeating
• Medium alert: 3 beeps, repeating
To adjust and test the audible alert signal volume level, go to the Settings screen, and press
or in the Volume field.
7.5 Visual alert signals
The alert light (Figure 2) on the device illuminates to indicate that there are prompts that may require a response. Visual alert signals
are divided into 2 categories: low alert and medium alert. The visual alert signal categories align with the audible signal categories.
See Section 13.4, Chapter 18, and Section 19.4 for the full list of prompts and corresponding visual alert signals.
• Low alert: alert light is illuminated, and not flashing
• Medium alert: alert light is flashing
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