Adverse Effects - Medtronic EL240 Gebrauchsanweisung

■
A strict anticoagulation protocol should be followed, and anticoagulation should be routinely monitored
during all procedures. The benefits of extracorporeal support must be weighed against the risk of
systemic anticoagulation and must be assessed by the prescribing physician.
■
"Perioperative products intended for transfusion shall be transfused through a filter designed to retain
particles that are potentially harmful to the patient."
■
This device 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.

Adverse Effects

None known.
Instructions for Use
Warning: The setup and use of this product is the responsibility of the attending clinician.
1. Remove the product(s) from the packaging carefully to ensure sterile fluid pathway.
Warning: Ensure aseptic technique is used during all stages of setup and use of this product.
Warning: Before removing the product from the packaging, inspect the packaging and product for damage. If
the packaging or product is damaged, do not use as sterility of the product may have been compromised and/or
performance may be affected.
2. Mount holder by attaching it firmly to the IV pole.
3. Remove the reservoir from its sterile wrapper and place it in the holder. Tighten luer cap(s).
4. Remove the blue cap from the inlet connector and connect the suction/anticoagulant line.
5. Remove the yellow cap from the vacuum port on the reservoir. Attach the vacuum line.
6. Connect an outlet drain line; either a 1.0 to 0.6 cm (3/8 in to 1/4 in) reducer or a 1.0 to 0.6 × 0.6 cm (3/8 in to
1/4 in × 1/4 in) "Y" adapter, to the 1.0 cm (3/8 in) outlet port on the bottom of the reservoir. Close the clamp(s)
on the leg(s) of the drain line.
7. Turn on the vacuum from 80 to 120 mm Hg. Do not exceed 150 mm Hg.
8. Prime the blood collection reservoir with a minimum of 100 to 200 mL of anticoagulant solution to completely
wet the filter material.
9. Adjust the flow of anticoagulant to a ratio of approximately 15 mL of anticoagulant solution/100 mL blood.
10. If the blood collection is not going to start immediately (within 5 to 10 minutes), the anticoagulant flow may be
stopped. Be sure to restart the anticoagulant solution prior to the collection of blood.
11. Blood collection may now begin.
12. If the blood is to be used for autotransfusion, follow the setup and operation instructions in the applicable
manufacturer's operator's manual.
AABB. Standards for Perioperative Autologous Blood Collection and Administration. 4th ed. Bethesda, MD: AABB; 2009:19.
1
6 Instructions for Use English
1