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Urgent Field Safety Notice COME Spectra Apheresis System Disposable Tubing Sets FSN BCT8Return of Disposable Sets to Manufacturer Term BCT Catalog Number: 70630 Lot Numbers affected: 10T15261, 10T15296,
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01
Ensure you have been properly trained on how to operate the Spectra Optia Apheresis System.
02
Confirm that all necessary supplies and kits are readily available.
03
Power on the Spectra Optia Apheresis System and log in with your credentials.
04
Follow the on-screen prompts to navigate through the system and select the desired procedure.
05
Check and confirm patient information before starting the procedure.
06
Connect the necessary tubing and lines to the patient and the Spectra Optia Apheresis System.
07
Start the procedure and monitor the process closely for any complications or issues.
08
Once the procedure is complete, ensure proper documentation of the process and patient status.
09
Disconnect the patient from the system and properly dispose of any waste materials.
10
Complete the necessary post-procedure tasks and ensure the system is properly cleaned and maintained for future use.

Who needs spectra optia apheresis system?

01
Individuals with conditions requiring therapeutic apheresis treatment such as certain autoimmune diseases, neurological disorders, or hematologic disorders.
02
Patients with end-stage renal disease in need of hemodialysis or apheresis treatment.
03
Hospitals, clinics, and healthcare facilities offering apheresis services to patients in need of blood component separation or therapeutic plasma exchange.
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Spectra Optia Apheresis System is a medical device used for therapeutic apheresis and cell collection procedures.
Medical professionals and healthcare facilities that perform apheresis procedures using the Spectra Optia System are required to file relevant documentation.
The Spectra Optia Apheresis System documentation should be filled out with accurate and complete information regarding the procedures performed and patient details.
The purpose of the Spectra Optia Apheresis System is to separate blood components for therapeutic treatments and/or cell collection for various medical purposes.
The information to be reported on the Spectra Optia Apheresis System includes patient details, procedure performed, blood component separation results, and any adverse reactions or outcomes.
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