Cooper Surgical Wallach UltraFreeze Instructions For Use Manual

Wallach® UltraFreeze™

x

Only

REF

Cryosurgical Instrument

Instructions for Use

(Including Five Spray Apertures)

900076 - 0.5 liter

1

TOP

ASSEMBLY

PRESSURE RELIEF
VALVE ASSEMBLY

LUER-LOK

4

3

5

CONNECTOR

TRIGGER

6

APERTURE

2

BOTTLE

ASSEMBLY

Wallach® UltraFreeze™ Cryosurgical Instrument • Instructions for Use

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Only

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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