Cooper Surgical Leisegang LM-900 Directions For Use Manual

Brand: Cooper Surgical

Model: Leisegang LM-900

Type: Directions For Use Manual

Cooper Surgical Leisegang LM-900 is a cryosurgery system that uses high pressure gas to freeze and destroy defined areas of benign or pre-malignant lesions. It is indicated for use in dermatology, gynecology, ophthalmology, otolaryngology, plastic surgery, podiatry, proctology, urology, and veterinary medicine. The LM-900 is a versatile system that can be used in a variety of clinical settings, including hospitals, clinics, and offices. It is a safe and effective treatment option for a wide range of conditions, including skin tags, warts, actinic keratoses, and other benign lesions.

Models 50501 and 50502

LM-900 Cryosurgery System

Directions for Use

INTRODUCTION

Model 50501 requires Medical Grade N

O (Nitrous Oxide) gas. Model 50502 requires Medical

Grade CO

(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 N

O (Nitrous Oxide) or CO

(Carbon Dioxide) gas cylinder is

available for the LM-900. The N

O or CO

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

20 POUND CYLINDER

CARRYING CASE

CLEANING PLUGS

& “O” RINGS

QUICK-CONNECT

CONSOLE TIPS CRYOGUN

MOBILE CART

LM-900 Cryosurgery System

Directions for Use

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

) 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

) for proper freezing to occur. A pressure below

600 psi (42 Kg/cm

) 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

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.

• 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. Remove one (1) disposable drape and two (2) security

bands from the package (See Figure 4-1)

5. On drape, make a 1/8” (approximate) slit on the distal

(narrow) side centered up to down. (See Figure 5-1)

6. Position tip tightly on cryogun, using finger pressure only.

(See Figure 6-1)

7. Slide large open end of drape over device.

(See Figure 7-1)

8. Through the slit, pull drape over tip and onto shaft.

(See Figure 8-1)

LM-900 Cryosurgery System • Directions for Use

Fig. 4-1

Fig. 5-1

Fig. 6-1

Fig. 7-1

Fig. 8-1

9. Using one (1) security band, wrap twice and seal distal

end of drape (near tip). (See Figure 9-1)

10. Using one (1) security band, wrap twice and roll band to

proximal end of drape (near handle). (See Figure 10-1)

11. Unit shown fully draped and secured.

(See Figure 11-1)

12. Turn arrow valve to “ON” position.

13. 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)

19. Pull drape off from back to front, inside out, similar to

a surgical glove. (See Figure 19-1)

20. 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.

LM-900 Cryosurgery System • Directions for Use

Fig. 9-1

Fig. 10-1

Fig. 11-1

Fig. 18-2

Fig. 18-1

Fig. 19-1

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.

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 800-444-8456 or 203-601-5200.

LM-900 Cryosurgery System • Directions for Use

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

3012-0287-CAIFU • Rev. A • 7/16

Made in the USA

EMERGO EUROPE

Molenstraat 15

2513 BH, The Hague

The Netherlands

EC REP

CooperSurgical, Inc.

95 Corporate Drive

Trumbull, CT 06611 USA

REP

Only

EXPLANATION OF SYMBOLS

Reorder Number

Serial Number

Consult instructions for use

Authorized Representative in the European Community.

Keep Dry

Fragile

Manufacturer

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.

LM-900 Cryosurgery System • Directions for Use

Cooper Surgical Leisegang LM-900 Directions For Use Manual

Brand: Cooper Surgical

Model: Leisegang LM-900

Type: Directions For Use Manual

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Cooper Surgical Leisegang LM-900 Directions For Use Manual

Cooper Surgical Leisegang LM-900 Directions For Use Manual

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