instructions for use - Clinical Innovations

 PRS-­‐1030 (RETRACTOR) INSTRUCTIONS FOR USE This retractor is intended for use on the patient with redundant tissue (i.e., panniculus), which potentially will interfere with surgical exposure. The retractor will allow the surgeon to retract redundant tissue out of the operative field. Notice the “HOLD HERE” and “PULL HERE” tabs. Use these areas to manipulate the retractor during application. No adhesive will be exposed at these locations when the backing is removed correctly. Tabs A, B and C are to be removed sequentially. The arrow and “MIDLINE” marks are guides to assist in orientation. The widest part of the device is to be placed on the panniculus with the midline arrow pointing toward the patient’s head. Order of use: Prep the skin, apply the product, drape. Prep: It is suggested that the patient be prepped and the skin allowed to dry before applying the retractor, if time allows. An alcohol-­‐based prep must be dry before applying the retractor. If you believe sterility has been breached, reapply prep over the device. (Some physicians prefer to double glove so as to discard the outer pair after the retraction.) Applying the Retractor: 1. If necessary, manually retract panniculus to expose the surgical site. Remove tab “A” and position the retractor 5cm above the incision line. Apply to patient. 2. Remove "B" panels. Hold in tension while smoothing onto patient’s skin from midline laterally. 3. Fold back the device and return the panniculus back to normal position. Remove “C” panel by simultaneously pulling “C” tabs. 4. Using the “HOLD HERE” and “PULL HERE” tabs, together, in tension, lift and pull retractor cephalad. When the desired retraction is obtained, apply to patient anchoring at the xiphoid, lifting the panniculus up toward the ceiling and pulling the device to the sternum to apply. NOTE: Retraction should now be optimal. If the panniculus is not retracted prior to applying panel "C", retraction will not be optimal. Therefore apply "C" after retraction, not before, as it will not be as effective. Warnings and Precautions: • Skin conditions should be assessed for integrity before affixing retractor to the dermis • Before applying to the surface of the skin, the skin must be clean, dry, free of all gels, liquids, grease, creams, etc • Do not place over the patient’s airways. • Do not place over abrasions, contusions, rashes or any open breaks in the dermis. • Not to be used intra-­‐wound • Do not leave on patient longer than 24 hours • Remove slowly while supporting the skin • Do not cut or modify this device • Do not re-­‐apply to the patient—single use only • Discard and dispose of properly after use P/N 050-­‐0785 Rev. A PRS-­‐1050 (EXTENDER) INSTRUCTIONS FOR USE The extender is intended for use with the PRS-­‐1030 retractor on patients with BMIs generally greater than 50. Notice the “HOLD HERE” tabs. Use these areas to manipulate the device during application. As with all Traxi retractors, no adhesive will be exposed at these locations when the backing is removed correctly. Tabs A and B are to be removed sequentially. The top part of the device is to be placed on the sternum with the “MIDLINE” arrow pointing toward the patient’s head. Order of use: Prep the skin, apply the PRS-­‐1030, apply the PRS-­‐1050, re-­‐prep (if necessary), drape. Prep: It is suggested that the patient be prepped and the skin allowed to dry completely before applying the retractor. An alcohol-­‐based prep must dry completely before applying the retractor. If you believe sterility has been breached, reapply prep over the device. (Some physicians prefer to double glove so as to discard the outer pair after the retraction). Applying the Retractor: 1. Apply the PRS-­‐1030 to the panniculus (see PRS-­‐1030 instructions for use). 2. Use tab “A” of the PRS-­‐1050 to remove the release liner and apply panel “A” to the sternum between the breasts near the sternal notch midline. 3. Use “B” tabs to remove the “B” panel, exposing the adhesive. 4. Push the panniculus cephalad toward the sternum, creating optimal retraction of the panniculus. 5. While holding the panniculus in optimal retraction, apply panel B of the PRS-­‐1050 to the PRS-­‐1030, thus creating a new anchor point in support of the optimal panniculus retraction, and then drape as usual. Warnings and Precautions: • Skin conditions should be assessed for integrity before affixing this tape to the dermis • Before applying to the surface of the skin, the skin must be clean, dry, free of all gels, liquids, grease, creams, etc • Do not place over the patient’s airways • Do not place over abrasions, contusions, rashes or any open breaks in the dermis • Not to be used intra-­‐wound • Do not leave on patient longer than 24 hours • Remove slowly while supporting the skin • Do not cut or modify this device • Do not re-­‐apply to the patient—single use only • Discard and dispose of properly after use