Medtronic autoLog IQ Benutzerhandbuch Seite 10

Size: 7 x 9 in (178 x 229 mm)
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.
• 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
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M967226A006 1B Medtronic Confidential
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502431-132
Composed: 2018-06-08 06:06:55
PSJ - Size-selectable package manual 02-MAY-2018