LM-900 Cryosurgery System

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1 LM-900 Cryosurgery System Models and Directions for Use

LM-900 Cryosurgery System Directions for Use INTRODUCTION Model 50501 requires Medical Grade N 2 O (Nitrous Oxide) gas. Model 50502 requires Medical Grade CO 2 (Carbon Dioxide) gas.

This Directions for Use document includes general and specific directions for use, and information on warnings and precautions, storage, cleaning, and disinfection.

2 LM-900 Cryosurgery System Directions for Use INTRODUCTION Model requires Medical Grade N 2 O (Nitrous Oxide) gas. Model requires Medical Grade CO 2 (Carbon Dioxide) gas. Each LM-900 has been tested prior to shipment. Proper care and maintenance should ensure a long useful life. This Directions for Use document includes general and specific directions for use, and information on warnings and precautions, storage, cleaning, and disinfection. Please contact our Customer Service department with any comments or questions. Send correspondence to: CooperSurgical Customer Service Dept. 95 Corporate Drive Trumbull, CT USA Phone: Toll Free CARRYING CASE MOBILE CART CLEANING PLUGS & O RINGS QUICK-CONNECT CONSOLE TIPS CRYOGUN 20 POUND CYLINDER THE LM-900 CRYOSURGERY SYSTEM No tools are required for assembly and operation of the LM-900 Cryosurgery System. The LM-900 is delivered in an attache carrying case along with interchangeable cryotips, a package of replacement O rings, cleaning plugs and a gas scavenging hose. On the end of the cryogun barrel is a tip protector, which is removed when a cryotip is used, and replaced when the cryogun is not in use. An empty 20 lb N 2 O (Nitrous Oxide) or CO 2 (Carbon Dioxide) gas cylinder is available for the LM-900. The N 2 O or CO 2 gas is used as the refrigerant for the cryogenic process. The LM-900 should be used only in a well-ventilated area. Consult your approved local compressed gas supplier. A twenty-foot (6.1 m) scavenging hose is provided to divert used gas away from the operator and patient. The mobile hand cart should be used for cylinder movement. Compressed gas cylinders should be refilled only by qualified suppliers. Do not allow the temperature where cylinders are stored to exceed normal room temperature. READ THIS ENTIRE DOCUMENT BEFORE OPERATING THE LM-900 CRYOSURGERY INSTRUMENT 1

3 INDICATIONS LM-900 Cryosurgery System Directions for Use The LM-900 is a cryosurgery system intended to be used in the process of controlled destruction of defined areas of benign or pre-malignant lesions. CONTRAINDICATIONS The LM-900 is not indicated for therapeutic treatments to the central circulatory or central nervous systems. CAUTION U.S. Federal law restricts this device to sale by or on the order of a licensed practitioner or licensed medical facility. WARNINGS Exposure to nitrous oxide may result in impairment of performance, cognition or dexterity. Ventilate well. Refer to instructions for venting nitrous oxide gas. Do not sterilize. Device must only be cleaned and disinfected. See cleaning and disinfection instructions below. PRECAUTIONS This device utilizes high pressure gas and must be used with care to avoid unexpected release of pressure. Maintenance and care must be taken to avoid injury to user and patient. Use only medical grade gas under pressure range psi (42-56 Kg/cm 2 ) for optimal freeze. Do not store gas cylinders above normal room temperature. It is the operator s responsibility to fit the exhaust hose between cryosurgical unit exhaust and disposal point to minimize gas exposure. Do not drag, slide or roll cylinders. Cylinders should be stored in upright position and firmly secured to prevent falling or tipping. Do not crimp or tightly bend the gas hose. The hose should be coiled no tighter than an 8 in. (20.3 cm) circle. A damaged hose must be replaced. Do not use tools to tighten connections. Hand-tightening is all that is required. Before disconnecting the console from the gas cylinder, turn gas cylinder valve OFF. Before changing tips, make sure gas is off at the console. If cryotips are dropped, they should be returned to the factory for inspection. GENERAL INSTRUCTIONS Check the gas cylinder to be certain that it contains adequate gas. The pressure gauge should read between 600 and 800 psi (42-56 Kg/cm 2 ) for proper freezing to occur. A pressure below 600 psi (42 Kg/cm 2 ) may not provide enough pressure for sufficient freeze or defrost, and is not recommended. The gas cylinder should be securely seated on the mobile cart, and fastened with the provided safety chain. The tubing leading from the console to the cryogun should be examined by running the tube between the thumb and forefinger. Check for any kinks or abrupt bends. A kink in the line can cause a weakness, which can erupt under pressure. Located between the tip and the gun barrel is an O ring seal, which should be inspected prior to each use. Before each use, test for proper operation by following the instructions below, except point the tip towards the floor while squeezing the trigger for several seconds. SCAVENGING HOSE A twenty-foot (6.1 m) scavenging hose (P/N ) is provided with the unit to divert gas away from the operator and patient to a remote, well-ventilated area. One end of the scavenging hose should be pushed over the exhaust muffler on the console of the cryo unit (mild soapy water will ease this operation), and the other end should lead to a remote, well-ventilated area. 2

VENTING NITROUS OXIDE GAS IN OPERATING ROOM, CLINIC OR OFFICE Exhaust gas for the LM-900 system using nitrous oxide can be safely vented in a number of

Vented into room exhaust ventilation system provided the ventilation system is a nonrecirculated type. 3.

CAUTION Use ONLY the exhaust hose provided by CooperSurgical / Leisegang. No substitutes allowed.

Any restriction may expand the probe exhaust tubing to the point of rupture. (See Caution #1.

Connect gas scavenging hose to exhaust muffler on console. Vent to remote location. 3. Select proper tip for cryosurgical procedure. 4.

4 VENTING NITROUS OXIDE GAS IN OPERATING ROOM, CLINIC OR OFFICE Exhaust gas for the LM-900 system using nitrous oxide can be safely vented in a number of ways. 1. Vented directly to the outside via the exhaust hose. 2. Vented into room exhaust ventilation system provided the ventilation system is a nonrecirculated type. 3. Vented to a dedicated system for venting anesthetic gases. The flow capacity of the system shall have a capacity of no less than 40 L/min. CAUTION Use ONLY the exhaust hose provided by CooperSurgical / Leisegang. No substitutes allowed. Substitute parts may result in SEVERE RUPTURE OR BURSTING of the tubing and a subsequent loud noise. Do not restrict or kink any hose. Any restriction may expand the probe exhaust tubing to the point of rupture. (See Caution #1.) DIRECTIONS FOR USE LM-900 Cryosurgery System Directions for Use 1. Tighten quick-connect to medical grade gas supply. 2. Connect gas scavenging hose to exhaust muffler on console. Vent to remote location. 3. Select proper tip for cryosurgical procedure. 4. Remove one (1) disposable drape and two (2) security bands from the package (See Figure 4-1) Fig On drape, make a 1/8 (approximate) slit on the distal (narrow) side centered up to down. (See Figure 5-1) Fig Position tip tightly on cryogun, using finger pressure only. (See Figure 6-1) Fig Slide large open end of drape over device. (See Figure 7-1) Fig Through the slit, pull drape over tip and onto shaft. (See Figure 8-1) Fig

LM-900 Cryosurgery System Directions for Use 9. Using one (1) security band, wrap twice and seal distal end of drape (near tip). (See Figure 9-1) Fig.

Unit shown fully draped and secured. (See Figure 11-1) 12. Turn arrow valve to ON position. Fig. 11-1 13. Apply probe to surgical site. 14.

Release trigger to defrost. 16. When procedure is complete, turn arrow valve to OFF position. 17. Shut off gas supply valve. 18.

Pull drape off from back to front, inside out, similar to a surgical glove. (See Figure 19-1) Fig. 19-1 20.

CLEANING INSTRUCTIONS WARNING: Do not use bleach or any product containing chloride in the cleaning of this product.

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.

5 LM-900 Cryosurgery System Directions for Use 9. Using one (1) security band, wrap twice and seal distal end of drape (near tip). (See Figure 9-1) Fig Using one (1) security band, wrap twice and roll band to proximal end of drape (near handle). (See Figure 10-1) Fig Unit shown fully draped and secured. (See Figure 11-1) 12. Turn arrow valve to ON position. Fig Apply probe to surgical site. 14. Squeeze trigger to freeze or push trigger forward to lock it in place during freeze mode. Note: Usual freeze time is one (1) to three (3) minutes. 15. Release trigger to defrost. 16. When procedure is complete, turn arrow valve to OFF position. 17. Shut off gas supply valve. 18. To remove drape cut distal and proximal security bands loose. (See Figures 18-1 and 18-2) Fig Fig Pull drape off from back to front, inside out, similar to a surgical glove. (See Figure 19-1) Fig Discard pieces according to federal and local regulations. CLEANING INSTRUCTIONS WARNING: Do not use bleach or any product containing chloride in the cleaning of this product. The LEISEGANG LM-900 Cryosurgical System and Probes can be cleaned using the following procedure: 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

6 LM-900 Cryosurgery System Directions for Use 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. 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 (2) 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. DISINFECTION INSTRUCTIONS Intermediate Level Disinfection of Cryosurgical Shaft 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 shaft moist. 2. Prior to performing Intermediate Level Disinfection of the cryosurgical gun shaft, cleaning must be performed following Cleaning Instructions. 3. Wearing appropriate protective equipment, hold the cryosurgical gun by the handle with the shaft pointing downwards at an angle. 4. Obtain a clean, disposable, absorbent, non-shedding cloth that has been submerged in a prepared high level disinfectant solution (Cidex OPA or equivalent) and wrung out so that dripping has ceased. 5. Begin wiping the shaft surface up and down the entire length of the shaft. Wipe the inner edge where the probe and shaft meet. 6. Continue wiping the surface of the shaft for one (1) minute. Re-submerge the cloth into the prepared high level disinfectant solution, wring out until dripping has ceased and repeat Step 5. 5

7 LM-900 Cryosurgery System Directions for Use 7. Inspect the shaft and any mating surfaces for soil deposits. NOTE: Mating surfaces can trap soils (crevices and inner edge). Ensure the soils are removed prior to continuing the disinfection of the shaft. 8. Repeat Steps 5 & 6 a minimum of two (2) more times for a total three (3) disinfection wiping cycles. 9. After the third cycle, obtain another clean, disposable, absorbent, non-shedding cloth, submerge it in the prepared high level disinfectant solution and wring out the cloth so that dripping has ceased. 10. Using the high level disinfectant soaked towel, wrap the shaft of the cryosurgical device tightly and let stand for the recommended contact time by the manufacturer. 11. Wipe the shaft with a clean, disposable, absorbent, non-shedding cloth that has been immersed in warm, potable water (35 C - 40 C) and has been wrung out so that dripping has ceased. NOTE: Be careful not to contact the inner tubing of the cryosurgical shaft with any liquid solution or water as this may cause irreversible damage. 12. Inspect the shaft and mating surfaces for any soil deposits. Repeat Steps 4 11 until the shaft is free of soils. 13. Using a soft, lint-free, clean cloth, pat the probe and shaft dry. 14. Apply isopropyl alcohol (70% or greater) to a soft, lint-free, clean cloth (do not saturate). Wipe down the cryosurgical system shaft, gun, handle, tubing and console. 15. Dry the components using clean compressed air or a soft, lint-free, clean cloth. High Level Disinfection of Cryosurgical Probes 1. Cryosurgical probes should be cleaned following the Cleaning Instructions prior to High Level Disinfection. Failure to perform cleaning according to this procedure may result in inadequately cleaned probes and may contribute to inadequate disinfection. 2. Immediately following the cleaning procedure and while wearing appropriate protective equipment, install the cleaning plug, ensuring the rubber O-ring is present. Installing a plug without an O-ring will cause the disinfectant to penetrate into the probe tip and will contribute to unit malfunction. Ensure the plug is tight prior to proceeding. 3. Prepare an ortho-phthalaldehyde based, high level disinfectant solution following the manufacturer s guidelines (recommended: Cidex OPA or equivalent). Do not use a disinfectant solution which contains hydrogen peroxide or chlorine as this will damage the probes and contribute to unit malfunction. 4. Carefully place the clean, plugged probes into the prepared solution and soak according to the manufacturer s recommended parameters to obtain high level disinfection. Failure to follow the manufacturer s recommended parameters may result in inadequate disinfection. 5. After the recommended soaking period has elapsed, follow the manufacturer s instructions for removal and rinsing. Failure to follow the manufacturer s recommended parameters may result in inadequate removal of residual disinfectant. Additional rinsing can be performed, however is not required as long as the recommendations by the manufacturer have been met. 6. Using a soft, lint-free, clean cloth pat dry the probes. Further drying can be achieved using clean compressed air. SERVICE Please do not attempt to service the LM-900 Cryosurgical System yourself. All service must be performed by CooperSurgical, Inc. Service department hours are between 8:30 AM and 5:00 PM, EST Monday through Friday. For assistance, please call or

8 LM-900 Cryosurgery System Directions for Use EXPLANATION OF SYMBOLS Reorder Number Serial Number Consult instructions for use EC REP Authorized Representative in the European Community. Keep Dry Fragile Manufacturer R x Only CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed practitioner or licensed medical facility. Product conforms to the Medical Device Directive 93/42/EEC CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT USA Phone: (800) Fax: (800) International Phone: (203) Fax: (203) Made in the USA EC REP EMERGO EUROPE Molenstraat BH, The Hague The Netherlands CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT USA CAIFU Rev. A 7/16

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