WALLACH
LL100 Two-Trigger Cryosurgical Unit for N2O Directions for Use Rev G May 2013
Directions for Use
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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.
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INSTRUCTIONS 1)
Remove protective sleeve which covers the tip of the instrument. Save the sleeve for protection if you need to transport the instrument at any time in the future.
2)
Secure the pressure gauge block to the cylinder. The hand wheel should be hand-tightened only.
3)
Open gas cylinder valve and observe gas pressure. Gauge needle should move to the green area. Note: Green area denotes proper pressure for operation. Yellow area denotes that cylinder pressure is too low for operation and cylinder needs to be changed. Red area denotes excess pressure. Vent tank as described in section titled “HOW TO VENT CYLINDER.”
4)
Choose appropriate sterilized cryotip with clear shield and install. Hand-tighten only. Do not use tools to tighten.
5)
To see if apparatus is working properly, it should be tested prior to use. Pointing to the floor; depress freeze trigger for several seconds. Tip should frost and smoke. Release freeze trigger and depress defrost trigger. Frost should disappear within 3 to 4 seconds. NOTE: The freeze trigger will automatically remain in the depressed position for your comfort. Depressing the defrost trigger will release the freeze trigger. (If you wish to release the freeze trigger without defrosting, momentarily depress and release the defrost trigger.)
6)
Apply cryotip to moistened treatment area. It is recommended that a lubricant be applied to the treatment site. Depress freeze trigger to freeze tissue.
7)
Depress and hold down defrost trigger to defrost the tip. Remove instrument from treatment area.
8)
When finished with treatment, set instrument in holder and shut off gas cylinder valve. NOTE: If treatment requires more than one tip, it is not necessary to shut off the gas cylinder valve while changing tips. Simply unscrew the tip presently in use, and replace with tip desired.
9)
To reduce concentration of N2O in the immediate cryosurgical area, you may vent the exhausted gas by attaching one end of the scavenger hose* to the exhaust port at bottom of the pressure gauge block. The other end of the hose goes to a discharge location. *Hose must have minimum of 6 mm internal diameter. We recommend Wallach Scavenger Hose Part #901015 (approximately 6 meters).
IMPORTANT SAFETY FEATURE Wallach has incorporated a rupture disk into the LL100™. This is a safety device that prevents damage to the instrument from overheated cylinders. Note: If tank is overheated and pressure reaches 1500 psi, gas will exhaust through the rupture disk instead of pressurizing the whole unit, thereby avoiding damage to the unit. The rupture disk is easily replaced by removing it with a 14.2 mm wrench. Additional rupture disks may be purchased from Wallach Surgical Devices. The rupture disk is not covered under the warranty.
HOW TO VENT CYLINDER CAUTION: MOVE CYLINDER TO A WELL-VENTILATED AREA. A.
Turn gas cylinder master valve completely off.
B.
Slowly loosen hand wheel nut on attachment to gas cylinder. This releases residual gas in the feeder hose. When hissing sound stops, remove pressure gauge block.
C.
Point cylinder opening away from you and slowly open the cylinder master valve just enough to hear gas steadily released. After approximately 15 seconds, close the valve.
D.
If cylinder is being vented to reduce overfilled condition, re-weigh cylinder before proceeding. Reconnect pressure gauge block; open gas cylinder valve and observe gas pressure. Gauge needle should point to the green area. Repeat the procedure if it still points to the red area.
HOW TO STORE LL100 BETWEEN PROCEDURES A.
Close cylinder master valve fully.
B.
It is not necessary to disconnect pressure gauge and tips from cylinder between procedures.
C.
Depressurize the unit by engaging the defrost trigger until pressure gauge drops to 0.
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IMPORTANT REMINDERS A.
Keep unit including cylinder at room temperature (68 ºC - 74 ºF, 18 ºC - 22 ºC). Cold will decrease the system’s efficiency and significantly increase defrost time. Heat causes excess gas consumption. Allow time for temperature recovery if extremes have been experienced.
B.
Never store or use cylinders near radiators, furnaces or other heat supplies.
C.
Do not mix or use gas other than N2O.
D.
Never siphon tanks of liquid N2O.
NOTE: For complete information on handling compressed gas cylinders, refer to Compressed Gas Association, www.cganet.com, email: [email protected]
WHERE TO REFILL GAS TO ENSURE OPTIMAL PERFORMANCE, ONLY MEDICAL GRADE GAS FREE OF CONTAMINANTS SHOULD BE USED. Medical grade N2O gas is available throughout the world. See your local telephone listing under any of these headings: Welding Supplies, Gas-Medical, Carbonic Gas, Soda Dispensing Equipment and Supplies. Many of these suppliers deliver to the office.
INSTRUCTIONS FOR CLEANING LL100™ The Wallach LL100 Cryosurgical unit can be wiped down with an appropriate disinfectant. This wipe down procedure can include the black plastic handle, white silicone gas hoses, gauge block and gas cylinder connector. Other methods involving heat, fluid (cold soaking) or steam are not recommended.
RECOMMENDATION FOR DISINFECTION OF INSULATION PROBE BASED ON CDC: GUIDELINE FOR 1 DISINFECTION AND STERILIZATION IN HEALTH CARE FACILITIES Some cryosurgical probes are not fully immersible. During reprocessing, the tip of the probe should be immersed in a high-level disinfectant for the appropriate time; any other portion of the probe that could have mucous membrane contact can be disinfected by immersion or by wrapping with a cloth soaked in a high-level disinfectant to allow the recommended contact time. After disinfection, the probe should be rinsed with tap water and dried before use. Health care facilities that use nonimmersible probes should replace them as soon as possible with fully immersible probes.
INSTRUCTIONS FOR CLEANING STERILIZABLE CRYOTIPS (900200AA – 900217AA) (900300AA – 900306AA) 1.
Remove disposable shield from cryotip and discard.
2.
Plug cryotip before cleaning and sterilizing. (Plug Orifice does not require sterilization).
3.
Scrub tip to remove blood and particles.
4.
Rinse with water.
5.
Cryotips can be steam sterilized by Gravity or Pre-vacuum using the following procedures:
Stage / Process
Parameter Set-Points
Set-up
Cycle Profile
Gravity
Pre-vacuum
Pre-Exposure (Conditioning)
Chamber Purge
1 minute
1 minute
132 °C (270 °F)
132 °C (270 °F)
Sterilization Time
15 minutes
4 minutes
Dry Time
15 minutes
20 minutes
Exposure (Steam Injection) Post-Exposure (Exhaust / Dry)
Sterilization Temperature
6.
Attach new disposable plastic shield to the cryotip, ensuring that the tabs on the shields are correctly fitted into the grooves on the metal tip.
7.
Cryotip is now ready to use.
WARNING: DO NOT USE ETO, E-BEAM OR GAMMA STERILIZATION.
1
Rutala, William A., Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC), CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, pg. 19, 2008.
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SERVICE AND REPAIR In case of malfunction, immediately turn gas cylinder master valve completely off. Detach instrument from gas cylinder. Call Wallach Surgical Devices at (203) 799-2000 and ask the Service Department for assistance. If a repair is needed, carefully sanitize and package the unit in a protective carton. Include a note stating the problem and ask for a repair estimate. Do not attempt in-house repairs as they will void your warranty.
WARRANTY The LL100™ system carries a five-year warranty. One year unconditional guarantee plus additional four year warranty agreement against manufacturer’s defects on parts and labor.
95 Corporate Drive Trumbull, CT 06611 USA Phone: 800-243-2463 (203) 799-2000 Fax: (203) 799-2002 [email protected] www.wallachsurgical.com EXPLANATION OF SYMBOLS
REF
Reorder Number
For Professional Use Only
SN
Serial Number
ATTENTION: See instructions for use. Over pressure Relief Device (single use rupture disk)
Air Flow (Gas Exhaust Port)
D E F
F R Z
Activate Defrost
Activate Freeze
Authorized European Representative: Leisegang Feinmechanik GmbH Leibnizstraße 32 D-10625, Berlin GERMANY
Product conforms to the Medical Device Directive 93/42/EEC
Latex Free
®
LL100™ and Wallach are trademarks of Wallach Surgical Devices © 2013 Wallach Surgical Devices
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