Intended Use; Procedures For Use - Terumo COBE Spectra 70100 Gebrauchsanleitung

Description
The Accessory Platelet Storage Set is a functionally closed accessory bag used for the storage of
platelets. The product consists of a platelet storage bag with two pieces of tubing attached: a
45.7 cm (18 in) segment with a capped male luer for venting during sterilization, and a 15.2 cm
(6 in) sealed segment.

Intended Use

The Accessory Platelet Storage Bag is used to aliquot and store collected platelets.
Warnings
Do not remove the cap on the luer. Removal of the cap will result in a breach of the closed
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system and reduce subsequent storage time to 24 hours.
Storage of platelets should be in accordance with the procedures specified in
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Terumo BCT's most recent platelet storage recommendations documentation. Use of the
Accessory Platelet Storage Bag does not extend the storage of platelets already stored in
collect bags beyond the recommended storage time.
Tubing sets manufactured by Terumo BCT contain DEHP. Results from selected studies
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of rodents exposed to DEHP (typically via an oral route) have shown potentially harmful
effects to male reproductive organs during fetal development. Because of this, patient
groups that include pregnant or nursing women and children are considered to be most at
risk to potential harmful effects of exposure to DEHP. However, no studies performed to
date involving other mammals and humans exposed to intravenous DEHP have shown
similar results. Regulatory bodies have noted that the risk of not doing a needed procedure
is far greater than the risk associated with exposure to DEHP. It is the responsibility of
treating physicians to balance this risk for their patients.
Cautions
Not for Reuse: Tubing sets manufactured by Terumo BCT bearing the not for reuse
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symbol are intended for single use only and are not intended to be reprocessed or reused.
Terumo BCT cannot ensure the functionality or sterility of the set if it is reprocessed or
reused.
The bag and tubing of this set are sterile and nonpyrogenic. Do not use the set if the end
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cap is not in place.
Disposable products may be subject to occasional failure which could result in the loss of
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platelets. It is very important that the operator carefully observe for leaks.

Procedures for Use

The Accessory Platelet Storage Bag is provided with pre-attached plasticized polyvinyl chloride
(PVC) tubing of the following specifications:
• Outer diameter: 4.06 ± 0.08 mm (0.160 ± 0.003 inches)
• Wall thickness: 0.559 ± 0.051 mm (0.022 ± 0.002 inches)
Refer to the instructions for use of sterile connection devices to connect the Accessory Platelet
Storage Bag to the collection bags on the sets.
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