L-CO2 Cryosurgical System Model 900116x Directions for Use Rev B Feb 2012

LL-CO2™ Cryosurgical System • Directions for Use (English) CAUTIONS

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U.S. Federal law restricts this device to sale by or on the order of a physician.

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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 of gas in order to begin the procedure. THE SYSTEM SHOULD NOT BE USED IF CYLINDER PRESSURE IS LESS THAN 650 PSI (45.70 kg/cm2) OR GREATER THAN 800 PSI (56.25 kg/cm2).

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In the event of a defrost failure, turn cylinder valve off, leave cryotip in place using sterile water or saline to expedite defrost or warming and then remove cryotip when defrost is evident.

TESTING THE CYLINDER PRESSURE CAUTION: The cylinder should be kept at room temperature (72 °F / 22 °C) for a minimum of 2 hours to ensure proper pressure readings. 1. Secure the cylinder yoke connector to the cylinder. Hand-tighten only. 2. Test the cylinder pressure and yoke connector assembly by placing the ON/OFF valve on the LL-CO2™ in the “OFF” position and then opening the cylinder valve fully with the handle. A reading between 650 psi (45.70 kg/cm2) and 800 psi (56.25 kg/cm2) should be indicated by the pressure gauge when opening a full cylinder. Pressure is dependent on fullness of cylinder and ambient temperature. At this time, any leaks should be audible. If necessary, tighten the yoke connector. 3. If the cylinder pressure exceeds 800 psi (56.25 kg/cm2), vent the cylinder. CAUTION: THE SYSTEM SHOULD NOT BE USED IF CYLINDER PRESSURE IS LESS THAN 650 PSI (45.70 kg/cm2) OR GREATER THAN 800 PSI (56.25 kg/cm2). HOW TO VENT THE CYLINDER CAUTION: MOVE CYLINDER TO A WELL-VENTILATED AREA. 1. Turn the gas cylinder master valve completely OFF. 2. Slowly loosen the yoke connector attached to the gas cylinder. This releases residual gas in the feeder hose. When the hissing sound stops, remove the pressure gauge block. 3. Point cylinder opening away from yourself and slowly open the cylinder master valve just enough to hear gas steadily being released. After approximately 15 seconds, close the valve. If the cylinder is being vented to reduce overfilled condition, re-weigh the cylinder before proceeding. Reconnect the pressure gauge block yoke connector; open gas cylinder valve and observe the gas pressure. The gauge needle should indicate between 650 psi (45.70 kg/cm2) and 800 psi (56.25 kg/cm2). Repeat the procedure if the gauge reads greater than 800 psi (56.25 kg/cm2). ASSEMBLY and OPERATION CAUTION: Gas cylinder must be secured to prevent it from falling over. Wallach offers a cart for this purpose. Please ask your customer service representative for details. 1. Remove the protective sleeve that covers the freezer tube of the instrument. Save the sleeve for protection if you need to transport the instrument at any time in the future as the inner tubing is fragile.

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LL-CO2™ Cryosurgical System • Directions for Use (English) 2. Choose an appropriate sterilized cryotip with a clear plastic shield and install it using an aseptic technique. Hand-tighten only - do not use tools to tighten. WARNING: Changing tips must be done with the ON/OFF valve in the “OFF” position. To ensure that gas is not flowing through the probe, wait at least 5 minutes before removing cryotip after use. Removal of the cryotip prior to 5 minutes may result in unexpected cryo damage to unprotected epithelium of the operator’s hand as well. 3. Tighten cylinder yoke connector to medical grade Carbon Dioxide gas supply. 4. With the cylinder master valve fully opened and the desired probe in position, turn the ON/OFF valve “ON”. NOTE: Test for proper operation by first pointing the tip toward the floor while squeezing the trigger. 5. Apply the end of the probe to the tissue to be treated. 6. Firmly squeeze the trigger to freeze or push trigger forward to lock it in place during freeze mode (usual freeze time is 1 – 3 minutes). 7. At the end of the freeze time, release the trigger to defrost. 8. Turn the ON/OFF valve to “OFF” and prepare for the next procedure. 9. When finished with treatment, turn the ON/OFF valve “OFF” and shut off the gas cylinder valve. NOTE: If treatment requires more than one cryotip, it is necessary to turn the ON/OFF valve “OFF” and shut off the gas cylinder valve while changing cryotips. After 5 minutes simply unscrew the cryotip presently in use, and using aseptic technique replace with cryotip desired. SHUT DOWN 1. With the ON/OFF valve "OFF", the cylinder yoke connector can be removed, or the cryotip can be replaced. 2. At the end of procedure-or at the end of the day-shut off the supply cylinder by turning the cylinder valve in the direction indicated on the valve. ADDITIONAL OPERATING INFORMATION

 It is recommended that CO2 cylinders be at room temperature in order to supply gas at the desired pressures. In some cases, cylinders stored outdoors in cold weather will not produce sufficient gas pressure. They must be warmed to room temperature for satisfactory operation.  Do not attempt to remove the cylinder yoke connector without first turning off the gas supply.  Do not unscrew the probe or remove the probe line quick-disconnect without first turning the ON/OFF valve “OFF” and releasing the trigger on the probe handle.  In case of inadequate freeze or premature defrost, check the following:  Low cylinder pressure: Replace cylinder under 650 psi (45.70 kg/cm2)  High cylinder pressure over 800 psi (56.25 kg/cm2): vent cylinder  ON/OFF valve partially open: Open valve fully  Obstruction in line or delivery tube: Return to Wallach Surgical for repair  Contamination in supply cylinder: Clean lines and replace supply cylinder  Leaks in fitting: tighten any fittings. NOTE: For complete information on handling compressed gas cylinders, refer to Compressed Gas Association, www.cganet.com, email: [email protected]

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LL-CO2™ Cryosurgical System • Directions for Use (English) HOW TO STORE THE LL-CO2™ BETWEEN PROCEDURES It is not necessary to disconnect the cylinder yoke connector from the cylinder between procedures. 1. Close the cylinder master valve fully. 2. Depressurize the unit by turning the ON/OFF valve “ON” until the pressure gauge drops to “0”. 3. After cryotip is removed, cover tip tubing with protective sleeve. CAUTION: WALLACH REUSABLE, STERILIZABLE CRYOTIPS SHOULD NOT BE USED WITHOUT DISPOSABLE CRYOSURGICAL TIP SHIELDS DUE TO THE FOLLOWING SAFETY HAZARDS!

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The shield acts as an insulator to prevent the tip from adhering to the tissue in unwanted areas.

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The tip will not freeze properly if threaded on too deeply. The shield works as a positive stop to prevent this from happening, provided that the tabs on the shield are correctly fitted into the grooves on the metal tip.

The tip could leak or disengage if not attached properly to the insulator tube; the shield will assure proper attachment.

INSTRUCTIONS FOR CLEANING THE LL-CO2 SYSTEM The Wallach LL-CO2 Cryosurgical System can be wiped down with a high level disinfection agent. This wipe down procedure can include the plastic handle, white silicone gas hoses, pressure gauge block and the gas cylinder connector. Other methods involving heat, fluid (cold soaking) or steam are not recommended. INSTRUCTIONS FOR HIGH LEVEL DISINFECTION OF INSULATION PROBE The white insulation probe which accepts the cryosurgical tip could have mucous membrane contact and should, therefore, be disinfected “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. As with other high-level disinfection procedures, proper cleaning of probes is necessary to ensure the success of the subsequent disinfection.”1 INSTRUCTIONS FOR CLEANING AND STERILIZING THE WALLACH CRYOTIPS 900200AA–900217AA and 900300AA–900306AA WARNING: DO NOT USE ETO, E-BEAM OR GAMMA STERILIZATION AS DAMAGE TO THE CRYOTIPS MAY OCCUR. CAUTION: 1. 2. 3. 4.

Remove the disposable shield from the cryotip and discard. Plug the cryotip before cleaning and sterilizing. (Plug Orifice does not require sterilization). Scrub the tip to remove blood and particles. Rinse with water. (Continued on the next page)

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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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LL-CO2™ Cryosurgical System • Directions for Use (English) 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

Sterilization Temperature

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)

6. Attach a new disposable plastic shield to the cryotip, using an aseptic technique. Ensure that the tabs on the shields are correctly fitted into the grooves on the metal tip. 7. The cryotip is now ready to use. WHERE TO REFILL GAS TO ENSURE OPTIMAL PERFORMANCE, ONLY MEDICAL GRADE CO2 GAS FREE OF CONTAMINANTS SHOULD BE USED. Medical grade CO2 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. WARRANTY Wallach Surgical guarantees the Wallach LL-CO2™ Freezer Cryosurgical System and Tips for a period of five (5) years against defects in material and workmanship. SERVICE AND REPAIR In case of a malfunction, immediately turn the gas cylinder master valve completely off. Detach instrument from gas cylinder. Call the factory at (203) 799-2000 and ask the Service Department for assistance. This device does not have any user serviceable parts. If a repair is needed, carefully sanitize the unit and package it 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.

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LL-CO2™ Cryosurgical System • Directions for Use (English)

SURGICAL DEVICES 95 Corporate Drive Trumbull, CT 06611 USA Phone: (203) 799-2000 Fax: (203) 799-2002 [email protected] www.wallachsurgical.com EXPLANATION OF SYMBOLS Reorder Number

For Professional Use Only

Serial Number

Product conforms to the Medical Device Directive 93/42/EEC

ATTENTION: See instructions for use.

Authorized Representative in the European Community.

Latex Free

Leisegang Feinmechanik GmbH Leibnizstraße 32 D-10625, Berlin GERMANY

LL-CO2™ is a trademark of Wallach Surgical Devices © 2012 Wallach Surgical Devices

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