Frigitronics CRYO-PLUS Model 2400 Operating & Maintenance Manual Revised March 2002

Caution

3 Unscrew the shell casing from the assembly.

1 Nitrous oxide cylinders must be at room temperature in order to supply gas at the desired pressure (760 psi nominal). 2 DO NOT attempt to remove the yoke assembly without first turning off the supply cylinder. To bleed the trapped gas, shut cylinder valve and turn ON/OFF valve "ON". Probe must be installed. 3 Keep toggle switch in center OFF/Shunt position when not in use to protect pyrometer from vibration. 4 DO NOT unscrew the probe without first turning ON/OFF valve "OFF" and releasing the trigger on the probe handle. 5 Nitrous oxide gas must be safely vented outside. 6 DO NOT restrict or kink any hose or tubing. Any restriction may expand the probe exhaust tubing to the point of rupture. Warning In the unlikely event of an uncontrolled freeze, simply turn the ON/OFF valve to "OFF" and irrigate the probe tip until it defrosts.

4 Unscrew the gas filter from the assembly and discard. 5 Open the hermetically sealed container and remove new gas filter. Note: DO NOT remove gas filter from container until ready to install. 6 Screw the new gas filter into the assembly and screw the shell casing into place. Ensure that the "O" ring seal is properly seated. No gas is permitted between shell and housing. If difficulty is encountered when installing the shell casing due to the "O" ring, replace worn "O" ring with a new replacement. "O" rings may need to be replaced with each filter change. 7 Open valves at the cylinders and check the purifier assembly for leaks. 8 It is recommended that the gas filter be replaced with each cylinder change. When the ON/OFF control valve is opened, N2O gas is supplied to the probe causing rapid cooling via the Joule-Thomson principle. Activating the trigger on the probe handle permits warm gas to be present in the probe for defrosting.

TroubleShooting In case of an inadequate freeze or premature defrost, check the following-

Introduction The Frigitronics® Cryo-Plus Cryosurgical System uses universally available nitrous oxide in a completely non-electric instrument to provide temperatures down to -890C. A selection of interchangeable screw-on probes with built-in thermocouples are available for procedures in gynecology, general surgery and otorhinolaryngology. When the ON/OFF control valve is opened, N2O gas is supplied to the probe causing rapid cooling via the Joule-Thomson principle. Activating the trigger on the probe handle permits warm gas to be present in the probe for defrosting. Cryo Probes

Console, Handle and Yoke Assembly

The probes are of high-quality stainless steel, welded construction. They are lightweight, slender and easy-tohandle. Available in a variety of configurations, all probes thread securely into the probe handle and feature a built-in thermocouple, which engages automatically. Consists of a cabinet containing a pressure gauge, ON/OFF valve, pyrometer and a three position "ProbeOff-T.C." switch. Attached to the rear of the cabinet is the yoke assembly. The probe handle assembly and the exhaust line connector are attached to the bottom of the console via a single coaxial line that supplies N2O to the probe and carries away the exhaust gas.

1

Cause

Remedy

• Low pressure

Replace cylinder (600 psi minimum).

• Cylinder Valve or ON/OFF valve only partially open

Open valve fully.

• Contamination in supply cylinder

Replace supply cylinder and purge line.

• Leaks in fitting

Check yoke seal, probe "O"-rings (2) and tighten fittings.

• Obstruction in line or delivery tube

Return to CooperSurgical for servicing.

• Temperature display not operational

Place toggle switch in "probe" position. Tighten probe onto handle.

• Will not defrost

Depress trigger fully, shut valve “OFF” and irrigate area.

6

Test Cylinder Pressure

Test cylinder pressure and yoke assembly by placing the ON/OFF valve in the "OFF" position and opening the cylinder valve fully with the handle provided. A reading of 740 to 800 psi should be indicated by the pressure gauge when opening a full cylinder. (Pressure is dependent on the fullness of the cylinder and ambient temperature.) The system SHOULD NOT be used if the pressure is less than 600 psi. Replace seal if needed and tighten yoke.

Note: Cylinder should be kept at room temperature (72OF) for a minimum of 2 hours to ensure pressure readings.

Operation 1 Place toggle switch in "Probe" position. 2 With desired probe in position, open the cylinder valve fully. 3 Freeze Test • Turn ON/OFF valve "ON". The tip of the probe will begin to freeze. Exhaust gas will be audible exiting the exhaust port. Monitor temperature. 4 Defrost Test • Firmly depress the trigger on the probe handle. The tip of the probe will defrost quickly. A slight gas flow will be audible. Monitor temperature. 5 Depress trigger and apply warm probe to the tissue to be treated to maximize conduction. Release the trigger to freeze and time the freeze duration. An optional timer is available. 6 Monitor freeze temperature to ensure adequate freeze performance.

Temperature Monitoring

With switch on the front panel in the "Probe" position, the pyrometer will indicate the probe tip temperature. In the T.C. position with the optional thermocouple attached, tissue temperature will be monitored. To install the T.C. needle, push the jack into the T.C. receptacle. The toggles can be switched anytime during the procedure. The OFF/Shunt position is used when no temperature reading is needed, and when moving or transporting the unit to protect the pyrometer from vibration.

Probe Exchange A probe should be on the probe handle at all times in order to protect the delivery tube from damage. Note: To exchange probes turn the ON/OFF valve to "OFF" and ensure that no gas is flowing through the probe by waiting at least 10 seconds before removing tip. 1 To remove a probe • Unscrew the probe using the knurled finger grip, turning counterclockwise. Caution: The probe must be slid straight forward until it clears the end of the delivery tube. 2 To attach a probe • Select the probe that is desired for the procedure. Check that 2 undamaged "O" rings are in place at the threaded end. Carefully place the probe over the delivery tube and screw on securely (finger tight). When resistance is met, tighten one additional turn.

3

7 At the end of the freeze time, depress the trigger to defrost the probe. Remove the probe from the tissue after the tip has completely defrosted ( 00C on the pyrometer). 8 Turn ON/OFF valve to "OFF" and prepare for second freeze. Shut Down At the end of procedure-or the end of the day-shut off supply cylinder by turning the cylinder valve clockwise. Put toggle switch in the center OFF/Shunt position. Cylinder Replacement Shut off the cylinder valve fully. With probe installed, turn ON/OFF valve to "ON" to safely relieve trapped gas until the pressure gauge reads "0". Turn valve OFF. Remove yoke, replace cylinder(s). Reinstall. Maintenance The Frigitronics® Cryo-Plus Cryosurgical System should be handled with the care required of any quality instrument. Avoid dropping or mishandling the unit and periodically inspect the lines, fittings, seals and probes for damage. A probe should always be kept in place over the delivery tube for protection.

4

Cleaning Tips, handle and lines can be wiped clean with a mild disinfecting solution or alcohol (minmum of 70% isopropyl alcohol) presently used in the office or hospital.

System Specifications

Weight: 5 lbs. Size: 73/4 inches wide X 4 inches deep Contents: Cryo-Plus w/cylinder yoke & probe assembly

Selection of probe tips 2 "O" rings 2 "E" yoke seals 2 20 lb. "G" yoke seals 20 foot scavenger tubing "E" cylinder tank handles Probe storage clip Operating & Maintenance Manual

Sterilization The Removeable Probe Tips may be sterilized by: Flash Autoclave 2800F maximum temperarure for a minimum of three minutes. Extended exposure time is required with lower temperatures. EO 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 Note:

The particular EO cycle should be validated per the equipment manufacturers 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.

CryoPlus probes may be disinfected or cold sterilized in cold sterilizing solution diluted with water in accordance with the manufacturer's direction. The probe MUST NOT BE immersed more than 6 inches (tip end only). Warning: Do not immerse or soak the line or handle. Do not let the solution reach probe handle, or enter internally.

System Set-Up 1 Place the "E" cylinders of medical grade nitrous oxide in the bottle cart. Orient the bottles so that the pin index (holes) in the valve face the pins on the yoke with the console facing forward. 2 Place the "E" cylinder yoke over the valve and insert the pins into the cylinder valve. If a double cylinder yoke is being used, set up both cylinders in the same manner. Be sure that the seal supplied with each "E" yoke is in place. Extra seals are provided. The alternate 20 lb. cylinder yoke and the "G" cylinder yoke are identical. Attach the yoke assembly to the gas cylinder and tighten. 3 Tighten the yoke "hand-tight" if using the "E" yoke, 20 lb. or "G" cylinder. 4 Place the round cylinder handle on the "E" cylinder valve. Exhaust Gas Venting

The built-in exhaust port is designed for the attachment of tubing to safely vent nitrous oxide gases out of the treatment area. Vinyl scavenger tubing is supplied. All tubing should be routed overhead to minimize the accidental restriction of the exhaust gases.

5 Connect the exhaust hose supplied by CooperSurgical to the console exhaust located on the bottom of the console.

Gas Purifiers Gas purifiers (optional) are available through CooperSurgical for systems being used in areas where gas contaminants (water, oil, vapor or solid impurities) may cause blockage and reduce operating efficiency.

6 Safely vent the other end of the hose in one of the following manners- A Directly to the outside. B Directly to a non-recirculated room exhaust ventilation system.

Filter Change Procedure

C Directly to a dedicated system for venting anesthetic gases. The flow

1 Shut off the valve or valves at all supply cylinders. 2 With probe in place, turn ON/OFF valve "ON" and bleed off the gas in the lines until the pressure gauge reads "0". Turn valve "OFF".

5

capacity of the system should not be less than 40 liters per minute. Caution: Use only the exhaust hose provided. Substitutes are not recommended. DO NOT restrict or kink the exhaust hose in any way.

2