Civco TP Pivot Pro Bedienungsanleitung Seite 5

TP Pivot Pro™ Needle Guide
Do not overtighten clamping knob. Overtightening may cause transducer damage.
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Ensure introducer needle is visualized when angled, to avoid puncturing the rectal wall.
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Withdraw or remove the introducer needle from the introducer holder to prevent patient injury when moving
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to a contralateral position.
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 State
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or appropriate regulatory authorities.
Use care when handling introducer needle to prevent accidental punctures.
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NOTE: Product is not made with natural rubber latex.
NEEDLE PATH VERIFICATION
Before using device, verify introducer needle is aligned within transducer imaging plane.
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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.
ATTACHING NEEDLE GUIDE TO TRANSDUCER
NOTE: Guide is compatible with endocavity transducers with a diameter in the range of 16mm - 20mm (0.63 -
0.79 inches).
1. Open transducer clamping knob by turning knob counter-clockwise and pivot knob away from attachment
legs. Do not remove knob from guide.
2. Place needle guide over transducer and push down to attach.
3. Align stabilizer window with sagittal image plane transducer lens.
4. Position guide to allow introducer needle to be visible in transducer array once inserted.
5. Pivot transducer clamping knob back into position and turn knob clockwise to securely attach needle guide to
transducer. Do not overtighten.
NOTE: If necessary, loosen transducer clamping knob to adjust needle guide position on transducer and ensure
needle path is aligned with transducer array. Do not remove knob from guide. Tighten transducer
clamping knob to secure needle guide after adjustment.
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