LM-900 CooperSurgical LEiSEGANG Models 50501 and 50502 Directions for Use Rev B April 2012

LM-900 Cryosurgery System Directions for Use (English) INTRODUCTION CooperSurgical is pleased you have chosen the LM-900 Cryosurgery System for use in your clinic or private practice. Model 50501 requires Medical Grade N2O (Nitrous Oxide) gas. Model 50502 requires Medical Grade CO2 (Carbon Dioxide) gas. Each LM-900 has been methodically handcrafted and tested prior to shipment. Proper care and maintenance should ensure a long and useful life. This Directions for Use document is intended to acquaint you with your new LM-900 Cryosurgery System. It includes general and specific directions for use, and information on warnings and precautions, storage, cleaning, disinfection and sterilization. CooperSurgical always stands ready to assist you. Please feel free to contact our Customer Service department with any comments or questions. Send correspondence to: CooperSurgical Customer Service Dept. 95 Corporate Drive Trumbull, CT 06611 USA 800-243-2974 203-601-5200

MOBILE CART

CARRYING CASE

CLEANING PLUGS & “O” RINGS QUICK-CONNECT

CONSOLE TIPS

CRYOGUN

THE LM-900 CRYOSURGERY SYSTEM

20 POUND CYLINDER

The LM-900 Cryosurgery System has been designed for easy assembly and operation. No tools are required. 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

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LM-900 Cryosurgery System • Directions for Use • English (continued) 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 N2O (Nitrous Oxide) or CO2 (Carbon Dioxide) gas cylinder is available for the LM-900. The N2O or CO2 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 INDICATIONS 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.

CLEANING WARNING: Do not use bleach or any product containing chloride in the cleaning of this product. CAUTION: Do not rinse or soak tips without first installing cleaning plugs. Make certain the cleaning plugs have rubber “O” rings in place to prevent liquid from entering the tips. Not using cleaning plugs will contribute to unit malfunction. The tips can be cleaned in mild soap and water solution with cleaning plugs installed and “O” rings in place. After cleaning, cleaning plugs should be removed and returned to the storage pouch. Cleaned tips can be stored on the metal studs located on the console. CooperSurgical recommends following the Centers for Disease Control (CDC) guidelines for disinfection and sterilization of non-immersible components by

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LM-900 Cryosurgery System • Directions for Use • English (continued) “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”1.

DISINFECTION WARNING: Cervical cryosurgical probes are recommended to have high-level disinfection between patients. The tips can be disinfected by soaking in a cold disinfectant with cleaning plugs installed and “O” rings in place. Clean tips before disinfecting. Follow CDC guidelines for disinfection1. Note: Limited well-designed studies available to base recommendations.

STERILIZATION WARNING: Do not autoclave this instrument. CAUTION: All cleaning and sterilization should only be done with cleaning plugs and “O” rings in place on tips. Not using cleaning plugs will contribute to unit malfunction. COLD STERILIZATION The tips can be sterilized by soaking in a cold sterilant with cleaning plugs installed and “O” rings in place on tips. Follow the manufacturer’s guidelines for sterilization. STERRAD® STERILIZATION Gas Plasma Processing (STERRAD Systems) can be utilized to process instruments and medical devices when following manufacturer’s instructions. Sterrad methods have proven to be effective, low-temperature sterilization processes, while being gentler than steam conditioning. Proceed per the sterilizer manufacturer’s recommended procedure. EO STERILIZATION Thoroughly clean and dry cryo tips prior to EO sterilization. Follow the manufacturer’s instructions for operation and loading of sterilizer and utilize a valid EO cycle. RECOMMENDED HOSPITAL ETHYLENE OXIDE CYCLE Temperature... 125 °F - 130 °F (52 °C - 54 °C) 50% RH (pre-humidity) . . . 60 minutes, -0/+10 minutes Pre Vacuum... 24 in. Hg ± 2 in. Hg (61 cm Hg ± 5 cm Hg) Gas Pressure... 6 - 8 psig (550 - 660 mg/L) Exposure Time... 4 hours -0/+0.25 hours Post Vacuum... 24 in. Hg 2X ± 2 in. Hg (61cm Hg 2X ± 5 cm Hg) Aeration... 12 -0/+1 hours at 120 °F (49 °C) 1

Guideline for Disinfection and Sterilization in Healthcare Facilities, CDC, 2008. 3

LM-900 Cryosurgery System • Directions for Use • English (continued)

PRECAUTIONS

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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.

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Use only medical grade gas under pressure range 600-800 psi (42-56 Kg/cm2) for optimal freeze.

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Do not store gas cylinders above normal room temperature.

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Do not drag, slide or roll cylinders. Cylinders should be stored upright and firmly secured to prevent falling or tipping.

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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.

It is the operator’s responsibility to fit the exhaust hose between cryosurgical unit exhaust and disposal point to minimize gas exposure.

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 cryo tips 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/cm2) for proper freezing to occur. A pressure below 600 psi (42 Kg/cm2) 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 3012-0314) 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.

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LM-900 Cryosurgery System • Directions for Use • English (continued)

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 non-recirculated 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.

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•. 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 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.

Position tip tightly on cryogun, using finger pressure only.

5.

Open gas supply valve on cylinder.

6.

Turn arrow valve to ON position.

7.

Apply probe to surgical site.

8.

Squeeze trigger to freeze or push trigger forward to lock it in place during freeze mode. Note: Usual freeze time is 1 to 3 minutes.

9.

Release trigger to defrost.

10. When procedure is complete, turn arrow valve to OFF position. 11. Shut off gas supply valve.

SERVICE The CooperSurgical Service Department is staffed with highly trained technicians whose primary responsibility is the safe and effective operation of your equipment. 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 800-444-8456 or 203-601-5200. 5

LM-900 Cryosurgery System • Directions for Use • English (continued)

EXPLANATION OF SYMBOLS Reorder Number Serial Number ATTENTION: See instructions for use. EC REP

Authorized Representative in the European Community. Keep Dry Fragile CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed practitioner or licensed medical facility.

0086

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

®

STERRAD is a registered trademark of Johnson & Johnson CooperSurgical is a registered trademark of CooperSurgical, Inc. © 2012 CooperSurgical, Inc.

Made in the USA 95 Corporate Drive Trumbull, CT 06611 USA Phone: (800) 243-2974 Fax: (800) 262-0105

EC REP

International Phone: (203) 601-9818 Fax: (203) 601- 4747

Leisegang Feinmechanik GmbH Leibnizstraße 32 D-10625, Berlin GERMANY

3012-0287 • Rev. B • 4/12

www.coopersurgical.com

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