Frigitronics CRYO-PLUS OPERATING & MAINTENANCE MANUAL REF 2400 R x Only CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
INDICATIONS FOR USE The Cryo-Plus is a cryosurgery system intended to be used in the process of controlled destruction of defined areas or benign or pre-malignant lesions. CAUTION 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 the ON/OFF valve to the "ON" position. 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 the ON/OFF valve to the "OFF" position 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, turn the ON/OFF valve to the "OFF" position and irrigate the probe tip until it defrosts. INTRODUCTION The Frigitronics Cryo-Plus Cryosurgical System uses nitrous oxide in a completely nonelectric instrument to provide temperatures down to -89ºC. 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, N 2 O 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. Consists of a cabinet containing a pressure gauge, ON/OFF valve, pyrometer and a three position "Probe- Off-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 N 2 O to the probe and carries away the exhaust gas. Cryo Probes Console, Handle and Yoke Assembly The probes are made from stainless steel. They are available in a variety of configurations. They thread into the probe handle, and include a thermocouple. System Weight: 5 lbs. Specifications Size: 7 3 /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 1
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. 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. C Directly to a dedicated system for venting anesthetic gases. The flow 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. DIRECTIONS FOR USE 1. A probe should be on the probe handle at all times in order to protect the delivery tube. (See Figure 1-1) Note: To exchange probes turn the ON/OFF valve to the OFF position and ensure that no gas is flowing through the probe by waiting at least 10 seconds before removing tip. Fig. 1-1 2. To remove a probe, unscrew the probe, firmly grasp the probe and turn counterclockwise. (See Figure 2-1) Caution: When attaching or removing the probe, the probe must be slid straight forward until it meets the handle or clears the end of the delivery tube. Fig. 2-1 3. To attach a probe, select the desired probe for the procedure. Check that two (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. (See Figure 3-1) Fig. 3-1 2
4. Remove one (1) disposable drape and two (2) security bands from the package. (See Figure 4-1) Fig. 4-1 5. On drape, make a 1/8 (approximate) slit on the distal (narrow) side centered up to down. (See Figure 5-1) Fig. 5-1 6. Slide large open end of drape over device. (See Figure 6-1) 7. Through the slit, pull drape onto shaft (approximately 1 inch proximal from end). Fig. 6-1 8. Pull drape up to or over the handle of the device. (See Figure 8-1) Fig. 8-1 9. Using one (1) security band, wrap twice and seal distal end of drape (near tip). (See Figure 9-1) Fig. 9-1 10. Using one (1) security band, wrap twice and roll band to proximal end of drape (near handle). (See Figure 10-1) Fig. 10-1 11. Unit shown fully draped and secured. (See figure 11-1) 12. Place toggle switch in "Probe" position. 13. With desired probe in position, open the cylinder valve fully. 14. Freeze Test Turn ON/OFF valve to the "ON" position. The tip of the probe will begin to freeze. Exhaust gas will be audible exiting the exhaust port. Monitor temperature. 3 Fig. 11-1
15. 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. 16. 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. 17. Monitor freeze temperature to ensure adequate freeze performance. 18. 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 (0 0 C on the pyrometer). 19. Turn ON/OFF valve to the "OFF" position. 20. To remove drape, cut distal and proximal security bands loose. 21. Pull drape off from back to front, inside out, similar to removal of a surgical glove. 22. Discard pieces according to federal and local regulations. SHUT DOWN At the end of procedure, 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 the ON/OFF valve to the "ON" position to safely relieve trapped gas until the pressure gauge reads "0". Turn valve to the "OFF" position. Remove yoke, replace cylinder(s). Reinstall. MAINTENANCE The Frigitronics Cryo-Plus Cryosurgical System should be handled with care. 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. CLEANING 1. Instruments should be cleaned as soon as possible. Do not allow blood and debris to dry on the instrument. If cleaning cannot be performed within a reasonable amount of time, keep the probe and shaft moist. 2. Wearing appropriate protective equipment, hold the cryosurgical gun by the handle with the shaft and probe pointing downwards at an angle. Ensure the probe is still secured to the gun shaft. The probe must remain secured to the gun shaft throughout the shaft cleaning. 3. Carefully rinse blood and debris from the shaft and probe of gun using cool water (20 C 25 C). Ensure that water does not contact the joint between the gun casing and the shaft. 4. During rinsing, use a clean, soft bristle brush to loosen and remove as much visible soil as possible from device. Focus brushing in challenging features such as mating surfaces and crevices. 5. Continue brushing and rinsing until no visible soil remains on the device. 6. Prepare a neutral ph enzymatic cleaner solution according to the Manufacturer s instructions. Immerse a clean, disposable, absorbent, non-shedding cloth into the cleaner solution and wring thoroughly. 7. Commencing with the gun shaft/casing joint, wipe thoroughly, especially in hard to reach areas. 8. During wiping, pour enzymatic solution down the shaft so that it runs the length of the shaft to the probe, but does not contact the shaft/casing joint. After pouring the solution, use a clean, soft bristle brush to reach challenging features with the cleaner solution. 4
9. Continue wiping and brushing for a minimum of one (1) minute. Repeat pouring the enzymatic solution during the brushing and wiping activities. Rinse the cloth in clean water and repeat steps 7 & 8 two or more times (for a total of three (3) iterations) to fully remove soils. 10. Thoroughly rinse the shaft and probe with warm (35 C-40 C) water until no visible detergent remains. While rinsing, use soft bristle brushes to clean out mating surfaces and crevices and other challenging features. 11. Using a soft, lint-free, clean cloth, pat the probe and shaft dry. Hold the gun facing downwards and carefully remove the probe. 12. Wipe the protected areas and inside threads of the shaft and probe with a clean, disposable, absorbent, non-shedding cloth that has been immersed in cleaner and appropriately wrung out. Continue wiping until all visible soil is removed. 13. Wipe the protected areas and threads of the shaft and probe repeatedly with a clean, disposable, absorbent, non-shedding cloth that has been immersed in clean water and appropriately wrung out. Rinse towel after wiping and repeat until no visible detergent remains. 14. Pat the probe and shaft dry using a soft, lint-free, clean cloth. Visually inspect the device for soil. Repeat the above cleaning procedure until no visible soil remains on the components. 15. Apply isopropyl alcohol (70% or greater) to a soft, lint-free, clean cloth (do not saturate). Wipe down the entire cryosurgical system (probe, shaft, gun, handle, tubing, console, etc.) for a minimum of one (1) minute. 16. Dry the components using clean compressed air or a soft, lint free, clean cloth. STERILIZATION The Removable Probe Tips may be sterilized by: Pre-Vacuum Autoclave Stage / Process Parameter Set-Points Set-up Cycle Profile Pre-vacuum Gravity Pre-Exposure (Conditioning) Chamber Purge 1 minute 1 minute Exposure Sterilization Temperature 132 C (270 F) 132 C (270 F) (Steam Injection) Sterilization Time 4 minutes 15 minutes Post-Exposure (Exhaust / Dry) Dry Time 20 minutes 15 minutes 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. FILTER CHANGE PROCEDURE 1. Shut off the valve or valves at all supply cylinders. 2. With probe in place, turn the ON/OFF valve to the "ON" position and bleed off the gas in the lines until the pressure gauge reads 0. Turn valve to the OFF position. 3. Unscrew the shell casing from the assembly. 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. 5
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, N 2 O 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 CAUSE REMEDY Low pressure Replace cylinder (600 psi minimum). Cylinder Valve or ON/OFF Open valve fully. valve only partially open Contamination in Replace supply cylinder and supply cylinder purge line. Leaks in fitting Check yoke seal, probe "O"-rings (2) and tighten fittings. Obstruction in line or Return to CooperSurgical for servicing. delivery tube Temperature display not Place toggle switch in "probe" position. operational Tighten probe onto handle. Will not defrost Depress trigger fully, turn valve to the OFF position and irrigate area. REPLACEMENT PARTS PART REORDER NUMBER O -Rings (2) 22092 Purifier Assembly P190 Gas Filters P191 T.C. Needles 2477 O -Ring Filter 10924 Optional Timers 2475 "E" Cylinder Handles 20364 "E" Yoke Seals (2) 20371 20 lb. "G" Yoke Seals (2) 21837 20 foot Scavenger Tubing 32873 Probe Storage Clip 2476 Operating & Maintenance Manual 35368 WARRANTY CooperSurgical warranties the Cryo-Plus System and probes for a period of one (1) year against defects in material and workmanship. 6
EXPLANATION OF SYMBOLS REF! Reorder Number Caution Consult instructions for use Nonsterile Not made with natural rubber latex Do not use if package is opened or damaged R x Only CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed practitioner or licensed Manufacturer Frigitronics is a registered trademark of CooperSurgical, Inc. 2016 CooperSurgical Inc. 95 Corporate Drive Trumbull, CT 06611 USA Phone: (800) 243-2974 Fax: (800) 262-0105 International Phone: (203) 601-9818 Fax: (203) 601-4747 www.coopersurgical.com CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 USA 35368-CAIFU Rev. A 7/16