Cooper Surgical Leisegang LM-900 Directions For Use Manual

Models 50501 and 50502

LM-900 Cryosurgery System

Directions for Use

®

INTRODUCTION

Model 50501 requires Medical Grade N2O (Nitrous Oxide) gas. Model 50502 requires Medical

Grade CO2(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 06611 USA

Phone:

800-243-2974 Toll Free
203-601-5200

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 N2O (Nitrous Oxide) or CO2(Carbon Dioxide) gas cylinder is
available for the LM-900. The N2O or CO2gas 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

20 POUND CYLINDER

CARRYING CASE

CLEANING PLUGS
& “O” RINGS

QUICK-CONNECT

CONSOLE TIPS CRYOGUN

MOBILE CART

LM-900 Cryosurgery System

Directions for Use

1

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.

• 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 600-800 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/cm2) 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 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.

LM-900 Cryosurgery System • Directions for Use

2