Frigitronics CS-76 Operating & Maintenance Manual Revised 2003

Introduction The Frigitronics CS-76 Cryosurgical System is a portable, non-electric instrument that uses universally available medical grade nitrous oxide to provide temperatures down to -890C. The unit consists of two stainless steel, vacuum insulated containers and a trigger-operated applicator. The applicator can be used for both intermittent or continuous spray applications, as well as with closed freeze tips. An adjustable regulator controls liquid flow and spray patterns according to the physician’s needs. An optional tissue temperature indicator (TTI) provides thermocouples and pyrometer for temperature measurement during cryosurgical procedures. ®

Filling the Unit 1 The CS-76 unit is manufactured for liquid nitrogen use only. 2 Before removing caps, turn vent knob to the open position and be certain that both gauges read zero. 3 Remove the pressure vessel cap and the liquid storage cap. 4 Fill pressure vessel to within two inches from the top with liquid nitrogen. Replace the cap hand-tight. DO NOT OVERTIGHTEN. Turn the vent knob to the closed position to allow pressurization. 5 Fill the liquid storage vessel to within two inches from the top with liquid nitrogen. Replace the cap. 6 When filling the unit, ALWAYS fill both sides. CAUTION: When the unit has liquid nitrogen in it, care should be taken to ensure that it remains upright.

6 The vent knob must be turned to the open position BEFORE the pressure vessel cap is removed. The vent knob should always be returned to the closed position AFTER the pressure vessel cap has been replaced. 7 When using a closed freeze tip, make certain the short return exhaust line (attached to the probe) is installed in the upward position. Connect the short return exhaust line to the exhaust entrance.

1 The system is ready for use when the pressure vessel gauge reads between 30 and 40 psig. 2 Operating pressure can be adjusted to the physicians needs by means of the operating pressure adjustment knob. Rotating the knob in the direction of the minus sign (counterclockwise) will lower the pressure. Rotating the knob in the direction of the plus sign (clockwise) will raise the pressure. 3 To operate, depress trigger on the CS-76 applicator. To interrupt the flow of liquid nitrogen, release the trigger. A continuous pulsing action can be attained for any spray tip by adjusting the operating pressure. 4 A manual lock on the applicator has been provided for continuous operation.

The Frigitronics® CS-76 Cryosurgical System may be cleaned with a mild detergent and water. Use a damp cloth and wipe dry Tips, handle and lines can be wiped clean with a mild disinfecting solution or alcohol (70% isopropyl alcohol) presently used in the office or hospital. Cidex cold soaking MUST NOT be utilized because it will attack the materials in the probe, and will introduce excessive amounts of liquid.

Temperature Indicator The Frigitronics® CS-76 Cryosurgical System tissue temperature indicator option (TTI) consists of a built-in temperature meter, two female receptacles for thermocouples, and a selector switch. Two tissue temperature thermocouples are supplied with each unit.

The thermocouple needle and tips may be sterilized by: FLASH AUTOCLAVE 2800F maximum temperature for a minimum of three minutes. Extended exposure time is required with lower temperatures.

The thermocouple needle assemblies can be steam autoclaved or gas sterilized. The metal thermocouple shields should be in place during sterilization for protection against mechanical damage to the tip. (See Sterilization section).

EO (ETHYLENE OXIDE) GAS Temperature...125-130°F 50% RH (pre-humidity)...60 minutes ...0/+10 minutes Pre Vacuum...24” Hg ± 2” Hg Gas Pressure 6-8 psig (550-660 mg/L EO) Exposure Time...4 hours minimum Post Vacuum...24” Hg 2X ± 2” Hg Aeration...12-0/+1 hours at 120°F

To use the unit, simply plug a thermocouple assembly into each of the receptacles.The assemblies are color-coded at each end, making it easy to distinguish one from the other. Select the thermocouple to be read by moving the selector switch to the appropriate position. CAUTION: To avoid damage to the TTI, the selector switch should be in the OFF position when not in use. NOTE: Maintenance 1 When not in use, the applicator should be stored in the retainer provided.

Operation

Cleaning and Sterilization

2 To prevent contamination, the pressure vessel cap and liquid storage vessel cap should be removed only when filling. 3 Periodic calibration of the tissue temperature indicator may be necessary. Do so in the following manner- Place the tip of a thermocouple needle into a bath of crushed ice and water. The temperature indicator should read 00C. If necessary, use the adjustment screw provided on the front of the meter to bring the pointer to 00C.

The particular EO cycle should be validated per the equipment manufacturer’s requirements. It is recommended that each institution employ procedures which include the use of biological indicators in order to determine the effectiveness of the ethylene oxide process.

The Frigitronics® CS-76 Cryosurgical System probes may be sterilized by autoclaving, flash autoclaving or EO gas, or in accordance with the manufacturer's direction. WARNING: Do not immerse or soak the line or handle. Do not let the solution reach probe handle, or enter internally.

Alternate Method- If ice is not available, place the tip of the thermocouple needle in liquid nitrogen and adjust the temperature indicator pointer, if necessary. The temperature indicator should read -1960C using this method.

5 The vent knob is normally in the closed position. The unit will not operate if the knob is in the open position.

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