CORTEX CryoPro Z10001FDA Multilingual Instruction Manual
- June 11, 2024
- CORTEX
Table of Contents
CryoPro Z10001FDA Multilingual
Z10001FDA Multilingual Instruction Manual
Manufacturer: CORTEX TECHNOLOGY ApS, Niels Jernes Vej 6B, Denmark
Intended Use
The Z10001FDA is a cryosurgery device designed for the treatment of the following conditions: Verucca vulgaris, basal cell carcinoma, and cervical cell changes. Freezing times may vary depending on the size and type of lesion, the aperture or probe used, and the freezing distance. The user is encouraged to familiarize themselves with available literature on cryosurgery using liquid nitrogen.
Maintenance
The Z10001FDA does not require any preventive maintenance.
Decontamination
Spray apertures do not usually require cleaning as they are not in contact
with the patient. However, if decontamination is necessary, the same procedure
as for closed contact probes applies.
Closed contact probes are in direct skin contact and should be cleaned and
steam autoclaved at 121 deg. C for 15 min. after use.
Prevent any liquid or steam from entering the interior of the contact probe
via the tube fitting and screw adapter. Ref. enclosed Z110030x.
Storing Liquid Nitrogen
To ensure a clean supply of liquid nitrogen, the storage tank (dewar) must
be completely emptied prior to refilling 3-4 times per year. If necessary,
water from ice crystals remaining inside the tank can be dried out by creating
air circulation (e.g. using a vacuum cleaner for approx. 30 minutes).
Warnings
- After filling, the top cover must be screwed on and tightened securely.
- Be careful when opening a pressurized unit. Unscrew the top slowly. The unit may still be pressurized even if with no residual liquid left.
Product Usage Instructions
Before using the Z10001FDA, familiarize yourself with the available
literature on cryosurgery using liquid nitrogen. For treatment, select an
appropriate probe size for the lesion. To facilitate the transfer of heat
between the skin and the device, moisten the lesion with a drop of water or
contact gel before freezing. Freezing times may vary depending on the size and
type of lesion, the aperture or probe used, and the freezing distance (spray
only).
FILLING THE UNIT
The CryoPro® unit is to be filled with liquid nitrogen only. Fill the unit by
slowly pouring liquid nitrogen into the top or by using a standard low
pressure withdrawal device from a storage tank (dewar). Depending on the
number of lesions to be treated and the duration of the individual treatments
the unit should be filled to 25 – 90 % of its maximum capacity. After filling
a warm unit, the liquid will boil violently for approx. 30 secs. Hereafter,
the top cover can easily be screwed on and tightened firmly. A weak but
audible hissing sound from the pressure relief valve indicates that the unit
has reached working pressure. This is normal and does not indicate an error
condition.
Caution should be taken when refilling a CryoPro® containing residual fluid as
the unit is pressurized at 0.74 bar. Slowly unscrewing the top cover will
allow the unit to depressurize before the top comes off. This is accompanied
by an audible hissing sound until it is fully depressurized.
INTENDED USE
Verucca vulgaris, basal cell carcinoma, cervical cell changes.
OPERATION
The CryoPro® is supplied with a set of standard spray apertures. Optional
closed probes are available for contact freezing. All probes and spray
apertures are screwed into the permanently affixed knurled nut with
fingertight firmness. Do not apply excessive force.
Do never use the CryoPro® without either a spray aperture or closed probe in
place. The excessive amount of liquid put out if the unit is used without
spray or probe attachment will cause severe damage to the patient.
Spray freezing ( REF OS A, B, C, D, SS, BS, SOFT, LL)
The spray apertures include: A (1 mm opening), B (0.75 mm opening), C (0.55 mm
opening), D (0.45 mm opening) as well as Bent Spray aperture (BS, 0.55 mm
opening) and Straight Spray (SS, 0.55 mm opening) both for areas difficult to
reach like behind the ears, lip and outer nose (avoiding gas into the
airways).
Select a spray aperture providing an LN2 output appropriate for the lesion to
be treated. In-depth freezing is best obtained when the spray aperture is
close to the lesion (5 – 10 mm distance) as the liquid content of the spray is
higher close to the aperture. When possible, raised warts should be approached
tangientally from at least two sides. This allows the ice ball to move down
through the wart while sparing the surrounding tissue. Spraying directly at
the lesion (perpendicular to the surface) will cause more lateral spread with
less penetration. To avoid this apply the spray intermittently or use a
smaller spray aperture.
The SOFT spray aperture is for freezing larger areas at greater distance (up
to approx. 5 cm) with higher vapor content. Move the aperture slowly back and
forth thus “painting” the surface with vaporized nitrogen.
A Luerlock adapter (LL) facilitates the use of a needle as a spray aperture.
The diameter of the needle determines the LN2 output according to the size of
the lesion.
Ref. enclosed E280010x.
Freezing times vary according to the aperture or probe used, the size and type of the lesion and the freezing distance (spray only). The user is encouraged to familiarize himself with available literature on cryosurgery using liquid nitrogen.
AFTER USE
At the end of an office day it is highly recommended to store the CryoPro®
with the lid on in order to prevent condensation inside the bottle. Build-up
of condensation may lead to clogging of the valve assembly.
MAINTENANCE
No preventive maintenance is needed.
DECONTAMINATION
Normally, spray apertures need no cleaning as they are not in contact with the
patient. However, should the need for decontamination arise, the same
procedure as for closed contact probes applies.
Closed contact probes are in direct skin contact and should be cleaned and
steam autoclaved at 121 deg. C for 15 min. after use.
Prevent any liquid or steam from entering the interior of the contact probe
via the tube fitting and screw adapter.
Ref. enclosed Z110030x.
STORING LIQUID NITROGEN
To ensure a clean supply of liquid nitrogen the storage tank (dewar) must be
completely emptied prior to refilling 3 – 4 times per year. If necessary,
water from icecrystals remaining inside the tank can be dried out by creating
air circulation (e.g. using a vacuum cleaner for approx. 30 minutes).
WARNINGS
- Do never use the CryoPro® unit without a spray aperture or closed contact probe in place.
- After filling, the top cover must be screwed on and tightened securely.
- The CryoPro® is supposed to be held in a vertical position when used. Liquid nitrogen may escape through the pressure relief valve if the unit is held in a position allowing the liquid inside the bottle to be in contact with the lid.
- Be careful when opening a pressurized unit. Unscrew the top slowly. The unit may still be pressurized even if with no residual liquid left.
The CryoPro® is a surgical instrument. When not in use it must be kept out of reach of children and unauthorized personnel.
