Civco CIV-FLEX Guía De Referencia página 4

ENGLISH
COVER
INDICATIONS FOR USE / INTENDED USE
Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead
instruments. The cover allows use of the transducer in scanning and needle guided
procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while
helping to prevent transfer of microorganisms, body fluids, and particulate material to the
patient and healthcare worker during reuse of the transducer (both sterile and non-sterile
covers). The cover also provides a means for maintenance of a sterile field (sterile covers
only). CIVCO Poly Ultrasound Transducer Covers are furnished sterile & non-sterile; single
use patient / procedure, disposable.
INDICATIONS FOR USE / INTENDED USE
To be used as a protective covering over ultrasound scanhead instruments and cord. Device
is a sterile sheath (cover/drape) allowing use of the ultrasound scanhead in the intra-
operative environment, including invasive surgical procedures where blood path indirect
contact is possible. The device provides maintenance of a sterile field, and protects patients
from cross-contamination. The device is designed for single use / disposable applications.
CAUTION
Federal (United States) law restricts this device to sale by or on the order of a physician.
WARNING
Before use, you should be trained in ultrasonography. For instructions on the use of
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your transducer, see your system's user guide.
See your system's user guide for reprocessing transducer between use.
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Disposable components are packaged sterile and are single-use only. Do not use if
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integrity of packaging is violated or if expiration date has passed.
Do not reuse, reprocess or resterilize single-use device. Reuse, reprocessing or
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resterilization may create a risk of contamination of the device, cause patient infection
or cross-infection.
Always place a cover over transducer to protect patients and user from cross-
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contamination.
Use only water-soluble agents or gels. Petroleum or mineral oil based materials may
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harm cover.
COVERING THE TRANSDUCER AND BRACKET
1. Place an appropriate amount of gel inside cover and/or on transducer face. Poor
imaging may result if no gel is used.
2. Insert transducer into cover making sure to use proper sterile technique. Pull cover tightly
over transducer face to remove wrinkles and air bubbles, taking care to avoid
puncturing cover.
3. Secure with enclosed bands or remove adhesive liner and fold cover over to enclose.
4. Inspect cover to ensure there are no holes or tears.
DISPOSAL
WARNING
Dispose of single-use components as infectious waste.
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LATEX-FREE TRANSDUCER COVERS