FreezPen Hand Held Cryosurgery Pen User Manual

Hand-Held Cryosurgery Pen
User Manual

Hand-Held Cryosurgery Pen

The Freeze is a non-invasive, non-sterile, reusable medical device for the cryogenic treatment of the following benign skin lesions: acrochordon, actinic keratosis, cheilitis, capillary hemangioma, cutaneous leishmaniasis, discoid lupus erythematosus; filiform, flat, vulgar, plantar and anogenital warts, rosacea, lichen sclerosis, granuloma annulare; molluscum contagiosum; seborrheic keratosis and viral lesions. Lesions are treated by applying an extremely precise flow of nitrous oxide directly on the lesion.
The lesion and its location must be always diagnosed by a healthcare professional.

| H &O Equipments
Rue des Journaliers 1
7822 Ghislenghien, Belgium.
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| +32 68 36 02 60
| +32 68 28 75 15
| info@clinic6.com
| www.clinic6.com
www.freezpen.com

Canadian license number 99271
Liability waiver: please read the section ‘Liability waiver’, page 13.

Important Notice

• When used correctly, the device does not come into contact with the lesion or the skin.

• When used normally, there is no need to perform any maintenance, cleaning, or disinfection.

• Should the applicator touch the patient in case of misuse, the applicator can be cleaned (autoclaved: 134 °C/273 °F – 4 min or 121 °C/250 °F – 20 min) and disinfected (use a non-corrosive disinfecting solution, follow the disinfecting solution manufacturer’s recommendations with regards to the concentration and time of application).

• Always handle your Freezpen and its components gently. Never use more than gentle hand force.

• Incorrect placement of the filter/opener will cause irreversible damage to the instrument.

• Leaving seals in the loading cavity while placing a new filter/opener will cause instrument failure.

• When loaded, the instrument is under high pressure. Any manipulation other than normal use may be dangerous.

• Never block the gas release opening at the top of the Freezpen’s back end!

• All external parts can be wiped with a cloth soaked in any non-corrosive disinfecting solution. Never immerse the entire instrument in a disinfecting solution.

• Never expose capsules to temperatures over 50°C/122°F. Leave the cap on the device when not in use.

• The Freezer should be handled with care.
  When storing the instrument ensure that the trigger is in the free position.

• Freeze instruments are intended for professional use only.

• The best results are obtained with the instrument and the capsules at room temperature (21°C/70°F). Lower and higher temperatures will give different values in respect of pressure and the density of the cryogen.
  Over 25°C/77°F, the quantity of liquefied N²O in the Freezpen jet will decrease.

• Empty capsules should be discarded as metal scrap.

Contraindications

• Unstable diabetes
• Skin conditions, e.g. skin tumors, exanthema, open wounds, solar hyperkeratosis
• Unexplained, suspicious liver spots and moles
• Cancer tissues and malignant tumors

Contraindications related to temporary conditions

• Infections accompanied by fever
• Acute chemotherapy or radiotherapy from four weeks before beginning the therapy to four weeks after finishing the therapy
• Pregnancy or breastfeeding
• Cold intolerance
• Vascular insufficiency

Possible side effects
Although cryotherapy is a relatively low-risk procedure, some side effects may occur as a result of the treatment. They include:
Permanent changes in pigmentation.
Both hypopigmentation (lightening of the skin) and hyperpigmentation (darkening of the skin) may occur after cryotherapy. Both generally last a few months but can be longer lasting.
Sensory impairment. Though rare, damage to nerves is possible, particularly in areas where these are positioned closer to the surface of the skin, such as in the fingers, the wrist,
and the area behind the ear. Reports suggest effects will disappear within several months.
A spattering of the cryogen during spraying, when the end nozzle freezes. The innovation of Freezpen is the direct application of nitrous oxide under high pressure (50-55 bar).
This high-pressure jet may cause minor shards of frozen humidity in the air to be blown away in a radius of approximately 30 cm. They will thaw the moment they might touch healthy skin.
Hair loss. Hair follicles are easily damaged by cryosurgery and permanent hair loss is not uncommon.
Pigmented spots. It is common to use to not treat pigmented spots in sunny seasons. Solar lentigines (SL) are flat, brown, sharply demarcated pigmented lesions that commonly appear as a sign of aging and photodamage on sun-exposed skin.

Instruments

Cartridges – Expired date on the cartridge’s packaging (shelf life 3 years).

8g N² O cartridges: 1 carton of 16 boxes each containing 21 cartridges| CL-N2O-8G-NORTON
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8g N2 O cartridges: 1 box of 21 pcs cartridges| CL-N2O-8G-INBOX
16g N²O cartridges: 1 carton of 12 boxes each containing 12 cartridges| CL-N2O-16G-NORTON
16g N²O cartridges: 1 box of 12 pcs cartridges| CL-N2O-16G-INBOX

Applicators

Rare side effects

• Edemas
• Bleeding
• Pain and fainting
• Insufflation of subcutaneous tissue
• Retraction caused by freezing next to orifices| • Cartilage defect during treatment of the nose or the ear
• Infection
• Conjunctival ectopy due to treatments of the eyelid
• Milia
• Depressed or atrophic scars.
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Steps:
Step 1 I Empty the loading cavity
Release any unused gas from the used capsule by unscrewing the applicator and pressing the button.
Then unscrew the capsule cover cap. Discard the used capsule and check that the cavity is entirely empty.
Step 2 I Load a new capsule
The capsules are delivered in blister packs with an assembled filter and capsule opener included.

Open the blister pack. Take out the filter/opener. Hold the tip of the Freezpen pointing downward. Place the filter/opener and make sure that it sits flat at the bottom of the loading cavity.
The trocar of the opener must be pointed upward. Take the capsule and place it in the cavity, on top of the filter/opener device.

Step 3 I Puncture the capsule
Keep the front end (tip of the Freezpen) pointing downward. Gently screw the Freezpen back end to the front end until you feel a little resistance. Now do one last twist in a rapid, uninterrupted rotation to puncture the capsule. You might hear a short hissing sound. The shorter the hiss, the better!
Step 4 I Use your Freezpen
Remove the applicator cap. Push the trigger to start the flow of cryogen. Release the trigger to stop the flow of cryogen. You may notice that after releasing the trigger, the remaining gas in the applicator is expelled. To switch the applicator, unscrew the current one and screw the other one on the Freeze.

The table below gives the estimated application with a continuous flow, and time depending on the applicator, and the cartridge size.
The measurements were done at 21°C (70°F).

| Freezpen 8g| Freezpen 16g| Lesion size
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Blue| 110-140 s| 250-280 s| 1-3 mm
White| 80-100 s| 180-210 s| 2-6 mm
Green| Χ| 145-165 s| 4-8 mm

Positioning the Freezpen

Hold the instrument vertically with the tip pointing downward. Never use the Freezpen at an angle of less than 45° from the vertical position.

Effective application
Before starting treatment consider the pathology, location, size, and depth of the lesion, the skin type, the degree of tanning, the season of the year, and other parameters that may influence the result of the treatment.
While using the Freezpen, the applicator tip with the jet of cryogen should be held 0.5 to 3 mm from the lesion. If the tip is held further than 5 mm from the lesion, the liquefied N²O will expand into a gas by the time it reaches the tissue, which is not effective for achieving therapeutic results.
By approaching the lesion with the jet already flowing you can observe the focal point of the jet on the tissue. The closer you get to the lesion, the more freezing power you will apply to the tissue.
It is recommended to keep a greater distance for the smaller and more delicate procedures.
The amount of liquid N²O that you wish to apply can be controlled by moving the applicator quickly towards and away from the tissue. Circular and crossing movements have the same effect.
Do not hold the Freezpen applicator still over the lesion. It may flood the area and damage healthy tissue surrounding the lesion. This can cause blisters and pain.
Condensation of humidity in the air on the frozen
working area during the procedure may create an ice layer on top of the lesion. This ‘igloo’ will prevent the liquid cryogen from working effectively (at -89°C/128°F): it should be removed with the applicator tip by gently wiping the ice.
Protect the area from blown ice shards, although they are relatively harmless.
After thawing, the tissue turns reddish and appears inflamed due to interstitial bleeding. Some edema and/or blistering may occur and cause discomfort for some hours.
Always protect this new-grown skin by using sunblock for 8 to 20 days after the scab has come off.

Duration/depth of the treatment

Hold the tip of the applicator as close as possible to the lesion. In all literature, the rapid drop in temperature (thermal shock) is described as a critical criterion. However, always take into account the part of the body being treated.
In some parts, the skin is thinner and requires more caution. A typical freeze on viral infections may last from 5 to 10 seconds for a small flat wart, and up to 45 seconds for a full-thickness plantar wart. In general, most lesions take about 2 to 30 seconds. The duration of the treatment will depend on the surface area and the thickness of the tissue.
Thickness must be estimated by the operator based on clinical experience.
After the first freezing cycle, the tissue should be allowed to thaw for about 30 seconds, followed by the second freezing. Please note that in the second cycle the tissue will freeze faster.
This ‘freeze-thaw-freeze’ technique is recorded in most literature on cryotherapy and gives the best results.
A follow-up visit is recommended to confirm that all the pathological tissue has disappeared or that follow-up treatment is necessary.

Patient comfort
Inform patients that there may be a pain sensation similar to a ballpoint being pushed onto the skin. Generally, little or no discomfort is experienced during the first few seconds if you avoid healthy tissue. The freezing effect will reach the deepest part of the lesion after a given amount of time depending on the depth of the lesion. From that moment, the patient will experience a pain sensation like a sting. This may be the moment to stop treatment. You may possibly add a few more seconds depending on the patient’s comfort level and your clinical evaluation. There might be a little residual stinging for some time after the treatment. Occasionally, a blister might form and persist for a few hours.

Liability waiver
Improper use, including excess freezing levels beyond those which are recommended or for an excessive duration, may result in bodily injury to clients/patients or to the operator. Clinic6 sprl and their affiliates, respective directors, officers, shareholders, employees, agents, and contractors are not liable or responsible, regardless of whether such liability or responsibility is based on breach of contract, tort, strict liability, breach of warranties, failure of essential purpose, fundamental breach or otherwise, for any death or injury, whether physical or mental or for any incidental, consequential, indirect, special or punitive damages, arising out of the Freezpen, its design, specifications, possession
and use, and treatment procedures, and whether or not any such death, injury, loss, or damage(s)result from the negligence, default, or error in judgment by Clinic6 sprl, their affiliates, respective directors, officers, shareholders, employees, agents and contractors, and even if advised of the possibility of such damages.
You agree to indemnify Clinic6 sprl, their affiliates, respective directors, officers, shareholders, employees, agents, and contractors, from and against any and all liability, damages, losses, costs, judgments, fines, penalties, and expenses (including legal expenses) of any kind or nature, including, without limitation, incidental, consequential, indirect, special or punitive damages, arising out of claims, demands, actions, causes of action, proceeding or suits, whether in law or in equity, due to any death, injury, loss, damage or damages as herein before referred to.

For more information visit our websites:
www.clinic6.com
www.freezpen.com

References

• Clinic6 | Freezpen | Cryosurgery made simple
• Clinic6 | Freezpen | Cryosurgery made simple

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