Before Use - Terumo 11221 Bedienungsanleitung

Intended Use
The Trima Accel ® Blood Component Sampling Set is intended for use with the Trima Accel Automated
Blood Collection System.
For a complete listing of contraindications, warnings, precautions, adverse effects and operating
instructions, refer to the Trima Accel Operator's Manual and the documentation enclosed with the
disposable tubing sets.
Warnings
1. Do Not Reuse/Not for Reuse: Terumo BCT, Inc. products bearing the "Do Not Reuse" symbol
are intended for single use only and are not intended to be reused or re‑sterilized in any manner.
Terumo BCT cannot ensure the functionality or sterility of the product if it is reused or
re‑sterilized.
Reuse of a single‑use product could result in:
• Product performance issues due to a loss of product integrity, including but not limited to
the following:
– Fluid leaks
– Parts that are warped or deformed
– Plastics that are brittle and discolored
– Filters that have reduced filtration capabilities
• Exposure to excessive ethylene oxide (EtO) residuals
• Viral infections such as hepatitis or human immunodeficiency virus (HIV)
• Bacterial infections
• Cross‑contamination
Any of these risks could result in serious injury or death. These risks are shared by product users,
donors, patients, and recipients of end products of the device.
2. This product contains phthalates (DEHP). Whole blood donors are not exposed to DEHP; the
potential health risk to apheresis donors is low, because the time-averaged DEHP dose exposure is
very low. Patient groups that include pregnant or nursing women and children are considered to
be the most at risk to potential harmful effects of exposure to DEHP. However, regulatory bodies
have noted that the benefit of doing a needed procedure is far greater than the risk associated with
exposure to DEHP. It is the responsibility of the treating physician to balance this risk for the
patient.
3.
Due to the possibility of occupational exposure to blood-borne pathogens when handling blood
products and contaminated sharps, always take appropriate precautions to prevent exposure to
and transmission of such agents.

Before Use

Prior to use, inspect the Blood Component Sampling Set to ensure that the end caps are in place, the set
is correctly assembled, and the set is not damaged. Do not use the set if it fails this inspection.
Note: Before sampling for bacterial testing, review the sample requirements and product storage
recommendations as stated in the operating instructions provided by the specific microbial detection
device manufacturer.
2