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If the product malfunctions during use or is no longer able to achieve its intended use, stop using the
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product and call CIVCO.
Report serious incidents related to the product to CIVCO and the competent authority in your Member
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State or appropriate regulatory authorities.
NEEDLE PATH VERIFICATION
Before using component for first time, perform needle path verification to verify system and biopsy guide
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relationships, as described in system user guide.
See transducer user guide for proper procedure.
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Use care when inserting needle to avoid bending.
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NOTE: Use appropriate needle length to reach target area.
USING NEEDLE GUIDANCE
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 cover with enclosed bands.
4. Inspect cover to ensure there are no holes or tears.
5. Using proper sterile technique, align guide with locating features of transducer.
6. Press down to secure to transducer.
7. If desired, apply secondary cover by following the steps above.
Disposable Endocavity Needle Guide
16-18 GA
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