WALLACH

LL100 Two-Trigger Cryosurgical Unit for N2O Directions for Use Rev G May 2013

Directions for Use

8 Pages

LL100™ Two-Trigger Cryosurgical Unit for N2O REF 900001, 900019-70, 900019-72, 900020, 900629, 900630  Directions for Use (English) READ ALL SAFETY INFORMATION AND INSTRUCTIONS BEFORE USING THIS PRODUCT! PRODUCT DESCRIPTION/USAGE The LL100™ is a cryosurgical unit used for ablative-type surgical technique. The popularity of this procedure can be attributed to several factors: applicability to multiple organ systems, a wide range of disease indications (i.e., viral and premalignant tissue), rapid procedural times, relatively low-cost, office-based suitability and minimal operative and post-operative complications. The 900001 is the main LL100 for N2O. The 900019-70 is the LL100 with the pinned yoke (British). The 900019-72 is the LL100 with a threaded connector. The 900020 is the LL100 short shaft Cryosurgical Freezer (N2O). The 900629 is the console freezer multi-tip with thermocouple. The 900630 is the console freezer multi-tip.  WARNINGS   DO NOT USE OVERFILLED CYLINDER; GAS PRESSURE MAY BE EXCESSIVE AND PRESENT A HAZARD. (9 KILO (19.8 LB) CYLINDERS SHOULD NOT CONTAIN OVER 9 KILOS (19.8 LBS) OF LIQUID N2O ONLY).    MOVE CYLINDER TO A WELL-VENTILATED AREA WHEN VENTING N2O. NITROUS OXIDE IN EXCESSIVE CONCENTRATION MAY BE HAZARDOUS TO HEALTH.    PERIODIC VISUAL INSPECTION OF CRYO INSTRUMENT AND TIPS IS ESSENTIAL. DISCONTINUE USE OF ANY PRODUCT SUSPECTED OF BEING DAMAGED. SUCH PRODUCT SHOULD BE RETURNED TO WALLACH FOR INSPECTION AND SERVICE.    AT NO TIME SHOULD CHLORINE MIXTURES (BLEACH) OR IODINE-BASED PRODUCTS BE USED FOR SOAKING OR CLEANING WALLACH CRYOTIPS. CRYOTIPS WILL DEGRADE IF EXPOSED TO SUCH SOLUTIONS.    MOISTURE IN LINES AND ORIFICES OF THE CRYOPROBE, CRYOTIP, AND CRYO CONSOLE CAN CAUSE SPUTTERING, POOR FREEZE AND OTHER MALFUNCTIONS. (WHENEVER USING FLUIDS OR STEAM TO CLEAN OR STERILIZE, ALL GAS LINES AND CRYOTIP ORIFICES MUST BE PLUGGED OR CORROSION MAY RESULT.) PLUGS ARE AVAILABLE FROM WALLACH FOR THE CRYOTIPS.    OVEREXPOSURE OF TISSUE MAY CAUSE CRYOGENIC BURNS (SIMILAR TO SEVERE FROSTBITE) AS A RESULT OF THE RAPID EVAPORATION OF THE LIQUIFIED GAS.  CAUTIONS   U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.    IN THE EVENT OF A DEFROST FAILURE, TURN TANK OFF; LEAVE TIP IN PLACE. REMOVE TIP WHEN DEFROST IS EVIDENT AND USE STERILE WATER OR SALINE TO EXPEDITE.    DO NOT DEPRESS TRIGGERS WHILE CHANGING TIPS. IF TRIGGERS ARE DEPRESSED WHILE CHANGING TIPS, INJURY MAY OCCUR DUE TO TIP SEPARATION FROM CRYOSURGICAL FREEZER.    WEIGH THE CYLINDER TO DETERMINE IF ENOUGH GAS IS AVAILABLE FOR THE PROCEDURE. THE EMPTY, OR “TARE” WEIGHT IS STAMPED ON THE CYLINDER VALVE OR SHOULDER. SUBTRACT THIS TARE WEIGHT FROM TOTAL WEIGHT TO DETERMINE WEIGHT OF GAS IN CYLINDER. SEE INSTRUCTIONS ON VENTING EXCESS WEIGHT. CYLINDER SHOULD CONTAIN A MINIMUM OF 1.36 KILOS (3 LBS) OF GAS IN ORDER TO BEGIN THE PROCEDURE.  IMCRY008 • Rev. G • 5/13  1  Wallach Surgical Devices
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