Indications For Use - Civco ENVISION Bedienungs- Und Referenzhandbuch

Envision™
INTENDED USE
The Envision cover and Envision pad are intended as a microbial barrier between the patient and medical imaging
electronics.

INDICATIONS FOR USE

The Envision cover and Envision pad are used, without the need for ultrasound coupling gel, in adult and pediatric
patients, for diagnostic ultrasound imaging, in sterile and nonsterile fields, that currently use an ultrasound coupling gel or
fluid alone or in combination with a protective transducer cover, including ultrasound guided venous access, ultrasound
imaging over surgical wounds, during transcutaneous biopsy; for intraoperative, endocavity, or transcutaneous imaging
procedures; or to enhance acoustic coupling to difficult geometries.
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 your transducer, see your
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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 integrity of packaging is
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violated or if expiration date has passed.
Dispose of single-use components as infectious waste.
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Do not reuse, reprocess or resterilize single-use device. Reuse, reprocessing or resterilization may create a
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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-contamination.
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Use only water-soluble agents. Petroleum or mineral oil based materials may harm cover.
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Organic solvents, such as alcohol, may damage the coating.
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NOTE: CONTENTS ARE NOT MADE WITH NATURAL RUBBER LATEX.
NOTE: THIS PRODUCT DOES NOT REQUIRE THE USE OF ULTRASOUND GEL.
USING ENVISION™
STANDARD WORKFLOW - ADHERING ENVISION TO TRANSDUCER
NOTE: Envision may also be safely applied directly to patient. If this workflow is desired, proceed to ALTERNATE
WORKFLOW section.
1. Hold Envision with liner and images facing upward.
2. Peel liner to expose adhesive.
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