Gambro Cobe Spectra Essentials Manual page 17

Warning: Use standard transfusion practices for cellular
components during RBCX procedures.
Warning: DO NOT unload pumps while the donor or patient is
connected.
Warning: Gambro BCT DOES NOT recommend performing
Rinseback during RBCX procedures. Rinseback volume is not
included in the predicted end hematocrit and the fraction of
original cells remaining calculations.
Warning: The extended storage of platelets at 22° C (71.6° F)
requires strict awareness of any possible sources of extrinsic
contamination. Pay rigorous attention to proper venipuncture site
selection and decontamination.
Warning: The Spectra system DOES NOT detect disconnection
of the return needle from donor or patient. The operator must
confirm the donor or patient is disconnected.
Warning: DO NOT disconnect the needle in a Single-Needle
procedure until the Rinseback operation is complete.
Warning: Only a qualified service representative should replace
the gear shroud. Incorrect replacement may cause injury to the
operator, the donor, or the patient.
®
COBE Spectra™ Apheresis System • Essentials Guide
Warning: The Spectra system can interfere with EKG monitoring
when a patient is simultaneously undergoing apheresis and EKG
monitoring.
Warning: The return pressure sensor does not detect all
infiltrations. Monitor the donor or patient for infiltrations.
Warning: The operator must verify the correct input of data
relevant to the safety (AC pump, inlet pump, inlet:AC ratio) of each
apheresis procedure.
Use only fillers and disposable tubing sets that Gambro BCT
manufactures for the Spectra system.
The manufacturer, assembler, installer or importer regards itself as
responsible for effects on the safety, reliability, and performance of
the device only if
•
Assembly, expansions, readjustments, alterations, or repairs
are carried out by individuals authorized by Gambro BCT.
•
The electrical wiring of the room conforms to the
requirements of IEC specifications.
•
The device is employed in accordance with the instructions
for use.
Preface
1-11