Intended Use; Contraindications; Warnings And Precautions - Medtronic autoLog IQ Manual Del Usuario

Size: 7 x 9 in (178 x 229 mm)
Figure 1. Whole blood separation
1 Whole blood inlet
2 Effluent outlet

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),
M967226A006 1B Medtronic Confidential
3 Plasma
4 Red blood cells
9
PSJ - Size-selectable package manual 02-MAY-2018
502431-132
English
Composed: 2018-06-08 06:06:55