Cortex Z1000117 CryoPro Cryotherapy Devices Instruction Manual

Cortex Z1000117 CryoPro Cryotherapy Devices

Product Information

Product Usage Instructions

Intended Use

This product is intended for the treatment of Verucca vulgaris, basal cell carcinoma, and cervical cell changes.

Freezing Times

The freezing times vary based on the aperture or probe used, the size and type of the lesion, and the freezing distance for spray. It is recommended for the user to familiarize themselves with available literature on cryosurgery using liquid nitrogen.

Decontamination

Spray apertures usually do not require cleaning as they are not in contact with the patient. However, if decontamination is necessary, the same procedure as for closed contact probes should be followed. Closed contact Probes that are in direct skin contact should be cleaned and steam autoclaved at 121 deg. C for 15 min after use. Care should be taken to prevent any liquid or steam from entering the interior of the contact probe via the tube fitting and screw adapter.

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 (eg, using a vacuum cleaner for approximately 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 there is no residual liquid left.

OVERVIEW

• Tmax = 50 °C
• Tmin = -196 °C
• PS = 0.76 bar
• Liquid nitrogen volume = 0.35 L (Mini) or 0.50 L (Maxi)

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.
• Contact freezing ( REF CP SP, CP 1mm-30mm, CX DS19, CX DS25, CX 19×5, CX 19×25, CX 25×5)
• Closed contact probes provide in-depth freezing with minimal lateral spread. Select a probe size fitting the size of the lesion. Make the lesion wet with a drop of water or contact gel prior to freezing to facilitate the thermal transfer between skin and probe tip.
• Apply the contact probe when still warm applying light pressure and pull the trigger handle.
• Keep freezing until a 1 mm halo is seen around the probe tip. Then stop the freezing and allow a few seconds for the probe tip to come loose.
• Ref. enclosed E280010x, Z111030x.
• 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.

Cortex Technology Aps

• Niels Jernes Vej 6B, 9220 Aalborg, Denmark

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