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TEMPOPACE TEMPORARY PACE WIRE NONABSORBABLE, SURGICAL SUTURE, USP/ Eur.Ph.         DESCRIPTION TEMPOPACE temporary pace wire is a nonabsorbable, sterile, twisted, insulated multifilament of stainless steel wire composed of 316L stainless steel. TEMPOPACE is insulated by FEP (fluorinated ethylene polypropylene) or PE (polyethylene) insulation. FEP coating is transparent and PE coating is blue colour. TEMPOPACE may also be labelled with the B&S gauge classifications.
INDICATIONS TEMPOPACE is indicated for use temporary atrial and ventricular pacing and sensing during and after cardiac surgery. TEMPOPACE is for single use only. ACTIONS TEMPOPACE is not absorbed. It is non-electro passive in tissue fluids. CONTRAINDICATIONS The use of this suture is contraindicated in patients with known sensitivities or allergies to 316L stainless steel, or constituent metals such as chromium and nickel. WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable, stainless steel sutures before employing for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used. PRECAUTIONS In handling this or any other suture material, care should be taken to avoid damage from handling, such as kinking or excessive twisting. ADVERSE REACTIONS Adverse effects associated with the use of this device include wound dehiscence, allergic response in patients with known sensitivities to 316L stainless steel, or constituent metals such as chromium and nickel infection, minimal acute inflammatory tissue reaction, pain, oedema, and local irritation at the wound site. Before the use of this device user should refer to instruction for use of pacemaker manufacturer. HOW SUPPLIED TEMPOPACE are available in sizes USP 3-0 and 0Â (metric sizes 2.0 -3.5) in a variety of lengths with and without permanently attached needles in one, two, and three dozen boxes. TEMPOPACE suture is supplied sterile. STORAGE Store below 25oC, Keep away from, sunlight. Protect from humidity. Do not use after expiry date.
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