Cooper Surgical Wallach UltraFreeze User manual

Wallach®UltraFreeze™
Cryosurgical Instrument
Instructions for Use
(Including Five Spray Apertures)
900076 - 0.5 liter
LUER-LOK
CONNECTOR
APERTURE
PRESSURE RELIEF
VALVE ASSEMBLY
TOP
ASSEMBLY
BOTTLE
ASSEMBLY
3
TRIGGER
1
2
4
5
6
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Wallach®UltraFreeze™ Cryosurgical Instrument • Instructions for Use
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CAUTIONS:
• U.S. FEDERAL LAW RESTRICTS THIS DEVICE FOR SALE TO, OR ON THE ORDER OF A
PHYSICIAN. IT IS INTENDED FOR PROFESSIONAL USE ONLY (LICENSED PHYSICIAN
OR VETERINARIAN).
• READ ALL OPERATING INSTRUCTIONS BEFORE ATTEMPTING TO FILL OR USE THIS
INSTRUMENT.
•
FOR USE WITH LIQUID NITROGEN ONLY. FOLLOW ALL APPLICABLE SAFETY
PRECAUTIONS FOR HANDLING LIQUID NITROGEN (Per MSDS). EYE PROTECTION SHOULD
ALWAYS BE WORN WHEN FILLING THE BOTTLE (2). GLOVES AND A PROTECTIVE APRON
ARE NECESSARY TO KEEP NITROGEN FROM CONTACT WITH THE SKIN.
•
LIQUID NITROGEN EXPANDS INSIDE THE BOTTLE TO PROVIDE OPERATING PRESSURE.
BEFORE SEPARATING THE TOP (1) AND BOTTLE (2), TO REFILL THE BOTTLE OR DISCARD
RESIDUAL FLUID, ENSURE THAT THE INSTRUMENT IS FULLY DEPRESSURIZED. SEE
SECTION “INSTRUCTIONS FOR USE” FOR PROPER DEPRESSURIZATION AND FILLING
PROCEDURES.
• DO NOT FILL THE BOTTLE MORE THAN ¾ FULL. OVERFILLING MAY CAUSE LIQUID NITROGEN TO BOIL
OUT OF THE CONTAINER WHEN ATTACHING THE TOP. ALSO, PERFORMANCE OF THE INSTRUMENT
MAY BE DEGRADED.
INDICATIONS FOR USE:
• The Wallach®UltraFreeze Liquid Nitrogen Sprayer , a product of CooperSurgical, is indicated for treatment of
cutaneous lesions amenable to cryosurgery.
• The Wallach UltraFreeze Liquid Nitrogen Sprayer is contraindicated for any other use.
INSTRUCTIONS FOR USE:
Device Description
The UltraFreeze Cryosurgical Instrument has two major components, the Top (1) and Bottle (2) Assemblies.
The Top Assembly comprises the Pressure Relief Valve (3), the Luer-Lok Connection (4) and the Main Valve
Trigger (5). It has an ergonomic grip and is fully insulated with Delrin® components. The Bottle Assembly (2) is
an insulated pressure vessel with Delrin® components: a collar for comfort; a skirt for stability. The Top is secured
to the Bottle using a threaded connection, with an O-Ring, and is separated with a counter-clockwise rotation.
As the Liquid Nitrogen within the Bottle becomes gaseous, the pressure within increases. The Instrument is
equipped with a Pressure Relief Valve (3), which will maintain the internal pressure below a predetermined level.
In normal operation, the user may perceive a ‘hissing’ sound as excess pressure bleeds off. The flow of Liquid
Nitrogen to the patient is initiated by pulling the Trigger (5) toward the Bottle. The closer the Trigger is to the Bottle,
the greater the flow will be. A variety of Open Apertures (6) or Closed Tips can be attached to the Luer-Lok
Connector (4). The Aperture orifice size is indicated by circumferential grooves adjacent to the connector.
The orifice size increases with the number of grooves present: ‘0’ Groove - 22 Ga.; ‘1’ Groove - 20 Ga.;
‘2’ Groove - 18 Ga.; ‘3’ Groove - 16 Ga. Included in the aperture kit is a 20 Ga. Curved Needle Tip for areas
difficult to reach with a spray aperture.
Filling the Ultrafreeze
Liquid Nitrogen can be purchased through your local gas supplier.
To fill the Bottle (2), unscrew the Top (1) from the Bottle. Fill by carefully pouring the liquid into the Bottle or by
using any standard dewar with a low pressure filler system. The recommended volume of liquid for a period of
3-8 hours of intermittent use is 3/4 full. Use enough fluid to perform the procedure.
To refill the Bottle, first depressurize by applying vertical or lateral pressure to the edge of the “Brass Plunger”
portion of the Pressure Relief Valve (3). Next, unscrew the Bottle one-half turn and wait until remaining pressure is
released. Remove the Top, add fluid, and reassemble. To hasten pressurization of the instrument, gently shake until
gas begins to escape from the Pressure Relief Valve (3).
The user should maintain a clean source of Liquid Nitrogen, as water or other foreign substances may interfere with
the operation of the instrument. To keep the supply clean, it is recommended that the storage container be emptied
completely at least four times a year.
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Wallach®UltraFreeze™ Cryosurgical Instrument • Instructions for Use
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OPERATING INSTRUCTIONS
Use of the UltraFreeze requires the attachment of a Closed Tip or Open Aperture. The Aperture size
is dictated by the type of lesion, the size and shape of the treatment area, and the amount of Liquid Nitrogen to be
delivered. The spray apertures with a larger orifice should be used for large, deep lesions. Apertures with smaller
orifices should be used for warts and keratoses.
Once the UltraFreeze has been filled with Liquid Nitrogen, the proper Aperture or Closed Tip must be
attached. The desired Aperture (6) is attached to the Connecter (4) by inserting the base and rotating approximately
1/4 turn clockwise. The instrument is now ready for use. The flow of nitrogen, delivered to the patient, is controlled
by the amount of pressure applied to the Trigger (5).
At the end of the day, empty and dry the unit. To ensure that all liquids are removed from the bottle, the components
should be air-dried separately, with the bottle and cap inverted. Foreign materials inside the bottle, even in small
amounts, will cause the instrument to malfunction (clogged tubes, valves held open, etc.). Any foreign materials
detected inside the bottle may be removed by wiping or rinsing with alcohol; DO NOT attempt to use the instrument
until the bottle is completely dry.
The Wallach Ultrafreeze should be cleaned and disinfected after each patient use.
CLEANING/DISINFECTION INSTRUCTIONS
After each patient use, follow the combined cleaning/disinfecting instructions provided below for the
Wallach Ultrafreeze.
1. Prepare an enzymatic, neutral pH cleaner solution according to the Manufacturer’s instructions.
2. Immerse a clean, lint-free wipe into cleaning solution and thoroughly wring. Thoroughly wipe bottle and top
assembly surfaces in a circular motion. Discard the wipe.
3. Using a soft, nylon brush, scrub difficult-to-access areas such as crevices or textured surfaces.
4. Immerse a fresh, clean, lint-free wipe under warm flowing, utility water and thoroughly wring excess water.
Thoroughly wipe the front panel surface and crevices for at least 30 seconds. Discard the wipe.
5. Rinse a fresh, clean, lint-free wipe under warm flowing, utility water and thoroughly wring excess
water. Wipe for at least 30 seconds. Discard the wipe.
6. Inspect the device for visible soil or debris. If visible soil remains, repeat cleaning steps 2-5 until device is
visually clean.
7. Using disinfection wipe, Caviwipes®, thoroughly wipe bottle and top assembly surfaces and discard the wipe.
Allow the wiped and wetted device to stand for a minimum of the disinfectant product manufacturer’s labeled
contact time. Re-wet the wipes as necessary to ensure that all surfaces remain wet the entire time.
8. Use a 70% IPA wipe, or a low-lint wipe, saturated with 70% IPA, to thoroughly wipe the device.
9. Allow the device to air dry. Once dry, visually inspect the device for any residual soil.
10. Repeat cleaning/disinfection instructions if visible soil is present.
11. Place the cleaned/disinfected device in an appropriate dry storage area
TROUBLESHOOTING
Problem Probable Cause Solution
A. No Pressure 1) System leaking. 1) Ensure Top is fully seated on Bottle.
2) Actuate Pressure Relief Valve.
3) Listen carefully to locate source of leakage
and call Repair Technician.
B. Excessive Frost on 1) Punctured bottle (cannot 1) Call Repair Technician and replace unit.
Bottle maintain pressure;
non-operational)
C. No flow of Liquid 1) Clogged Aperture or 1) Clean Aperture with a pin or needle.
Nitrogen Instrument. 2) Call Repair Technician.
D. Main or Pressure Relief 1) Valve frosted over or 1) Depressurize and remove Top. Thaw at room
Valve stuck open frozen. temperature, wipe dry. Reassemble and test.
2) Call Repair Technician.

Wallach®UltraFreeze™ Cryosurgical Instrument • Instructions for Use
SERVICE/REPAIR:
In case of malfunction, call the CooperSurgical Service and Repair Department at [phone] for
assistance. If a repair is needed, carefully sanitize and package unit in a protective carton. Include a note
stating the problem and ask for a repair estimate.
DO NOT ATTEMPT IN-HOUSE REPAIRS; THIS WILL VOID YOUR WARRANTY.
WARRANTY:
The UltraFreeze is supported by a three-year warranty from date of purchase covering any failure
of the device due to defective workmanship or components, when used in compliance with the product’s
indicated use. Only authorized service and repair professionals are permitted to repair this unit. If repair is
attempted outside the factory, the warranty will be considered void.
EXPLANATION OF SYMBOLS
Reorder number
Serial number
Extreme Cold
Keep Dry
Fragile
This side up
Consult instructions for use
Caution
Non-sterile
Do not use if package
is damaged
CaviWipes®is a registered trademark of Metrex Research Corporation.
© 2018 CooperSurgical, Inc.
Made in the USA.
Not made with natural
rubber latex
Caution: U.S. Federal law restricts this device
to sale by or on the order of a physician.
Authorized European Representative
in the European Community
Manufacturer
!
REF
SN
EC REP
LATEX
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IMCRY012-IFU-B • Rev.A • 09/18
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: [phone] • Fax: [phone]
International
Phone: [phone] • Fax: [phone]
www.coopersurgical.com
EC REP
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Made in the USA