Indications; Contraindications; Warnings - Gambro Cobe Spectra Essentials Manual

Indications

The Spectra system is intended for use in apheresis procedures for either
collections or therapeutic applications involving donors or patients.
Some of the products the Spectra system collects are mononuclear cells.
The United States Food and Drug Administration (FDA) continues to
develop its regulatory approach for mononuclear cells.

Contraindications

There are no known contraindications for use of the Spectra system
except those associated with the infusion of solutions and replacement
fluids as required by the apheresis procedure and those associated with all
types of automated apheresis systems.

Warnings

Below are warnings that appear in the manual. Many of the warnings
instruct you to contact Gambro BCT. U.S. customers should call
Gambro BCT Customer Support. Customers outside the U.S. should
contact their local Gambro BCT representative.
For the Spectra System
Warning: When handling extracorporeal blood circuits, take
adequate precautions to prevent the possible exposure to and
transmission of the hepatitis virus, human immunodeficiency
virus, and other infectious agents.
Warning: Before connecting the donor, check the access and
return lines for air. If air is present in the lines, remove air before
connecting the donor.
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COBE Spectra™ Apheresis System • Essentials Guide
Warning: Before connecting the patient, check the access and
return lines for air. If air is present in the lines, remove air before
connecting the patient.
Warning: Before connecting the donor/patient, check the
access and return lines for air. If air is present in the lines, remove
air before connecting the donor/patient.
Warning: To avoid possible injury or loss of life to the donor or
patient, use only operating or maintenance procedures published
by Gambro BCT, and accessory devices recommended by
Gambro BCT.
Gambro BCT will not be responsible for donor or patient safety if
the procedures used to operate, maintain, and calibrate the
Spectra system are other than those specified by Gambro BCT.
Individuals performing the procedures must be appropriately
trained and qualified.
Only qualified individuals should perform equipment modifications,
and Gambro BCT must approve, in writing, any modifications.
All electrical installations must comply with all applicable local
electrical codes and Gambro BCT specifications.
Warning: To reduce the risk of electric shock, DO NOT use
alternate power plugs or adapters that disconnect the green or
green/yellow wire safety ground.
Warning: To avoid accidental removal of additional blood from
the donor or patient, or accidental return of fluids to the donor or
patient, disconnect the access before starting Rinseback mode.
During Single-Needle procedures, close the white pinch clamp
between the "Y" manifold and the access manifold.
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