Multi-Pro 2000
INTENDED USE
• The bracket and disposable guide provide physicians with a tool for performing
needle-guided (or catheter) procedures with the use of diagnostic ultrasound
transducers.
• In the U.S.A., federal law restricts device to sale or use by or on order of a physician.
WARNING
• Before use, you should be trained in ultrasonography. For instructions on the use of your
transducer, see your system's manual.
• Transducer covers containing natural rubber latex may cause allergic reactions. In the
USA, refer to FDA Medical Alert MDA91-1.
• Use only water-soluble agents or gels. Petroleum or mineral oil based materials may
harm cover.
• Disposable components are packaged sterile and are single-use only. Do not use if
integrity of packaging is violated or if expiration date has passed.
• For illustration purposes only, transducer may be shown without a transducer cover.
Always place a cover over transducer to protect patients and users from cross-
contamination.
• Do not reuse, reprocess or resterilize single-use device. Reuse, reprocessing or
resterilization may create a risk of contamination of the device, cause patient infection
or cross-infection.
I. ATTACHING BRACKET TO TRANSDUCER
• Bracket is packaged non-sterile and is reusable. To avoid possible patient contamination,
WARNING
ensure bracket is properly cleaned, sterilized or disinfected before each use.
• If bracket does not fit properly, do not use.
1. Attach bracket to transducer by aligning locating features. Ensure bracket is firmly
attached.
II. 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 cover with enclosed bands.
4. Inspect cover to ensure there are no holes or tears.
III. ATTACHING NEEDLE GUIDE TO BRACKET
1. Using proper sterile technique, snap needle guide onto attachment area of bracket.
2. Select appropriate size needle guide insert and slide into position.
NEEDLE PATH VERIFICATION
3. Before using component for first time, perform needle path verification to verify
system and biopsy guide relationships, as described in system manual.
4. Use appropriate needle length to reach target area.
IV. ACTIVATING NEEDLE GUIDE RELEASE
1. Remove needle insert and move transducer.
V. DISPOSAL
WARNING
• Dispose of single-use components as infectious waste. Clean and sterilize reusable
components after each use.
Needle Guidance System
™
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English