H O EQUIPMENTS S-HO-CESPE-00 XPS CryoPen User Manual
- June 16, 2024
- H O EQUIPMENTS
Table of Contents
H O EQUIPMENTS S-HO-CESPE-00 XPS CryoPen
Product Information
Specifications
- Manufacturer: H&O Equipments nv/sa
- Expected Lifetime: Minimum 10 years in normal use
- 8g N2O cartridges: 1 carton of 12 boxes each containing 24 cartridges for use with CryoPen XPS and CryoPen XP
- 16g N2O cartridges: 1 carton of 12 boxes each containing 6 cartridges for use with CryoPen XP
Product Usage Instructions
Step 1: Load a new cartridge
- The cartridges are packed in peel-pack blisters with an assembled filter/opener included. The filters are used for the protection of the applicator, and the opener for puncturing the cartridge.
- CryoPen XPS can be used with 8g N2O cartridges only. CryoPen XP can be used with 16g N2O cartridges and with 8g N2O cartridges, thanks to the converter 16/8g.
- Ensure that the cavity is empty of any remaining parts.
- Open the peel-pack.
- Take out the filter/opener with the tweezers.
- Hold the CryoPen’s tip end pointed downward.
- Place the filter/opener in the instrument and make sure that it is seated flat at the bottom of the loading cavity.
FAQ
Q: What are the contraindications related to temporary conditions?
A: The contraindications related to temporary conditions are not mentioned in the provided text. Please refer to the complete user manual for more information.
Q: What are the possible side effects of cryotherapy?
A: Although cryotherapy is a relatively low-risk procedure, some possible
side effects may occur as a result of the treatment. These include:
- Temporary redness or swelling of the treated area
- Pain or discomfort during or after the treatment
- Blisters or skin irritation
- Changes in skin colour or texture
Q: How can I contact H &O Equipments for support or inquiries?
A: You can contact H&O Equipments using the following contact details:
- Telephone: +32 68 26 86 00
- Fax: +32 68 55 28 48
- Email: info@ho-equipments.com
- Website: www.ho-equipments.com
OVERVIEW
The serial number is engraved in the cavity for CryoPen XP and on the top of the frontend thread for CryoPen XPS Please mention your instrument’s serial number on all communication with H&O Equipments.
This user manual is applicable for the following products and accessories.
INSTRUMENTS – Expected lifetime : minimum 10 years in normal use.
- CryoPen XPS with support, blue, and grey ring applicators………………………………………………………………………………………………………………S-HO-CESPE-00
- CryoPen XP with support, blue, grey, green and yellow ring applicators + converter………………………………………………………….S-HO-CEPE-01
The instrument, the applicators, the tweezer and the user manual come in a hard case for easy transportation.
CARTRIDGES – Expiring date printed on the cartridges packaging.
8g N2O cartridges: 1 carton of 12 boxes each containing 24 cartridges
- for use with CryoPen XPS and CryoPen XP………………………………………………………………………………………………………………………………………..S-HO-NOCX-12-S24
- 16g N2O cartridges: 1 carton of 12 boxes each containing 6 cartridges
- for use with CryoPen XP……………………………………………………………………………………………………………………………………………………………………………….S-HO-NOCX-12-S06
APPLICATORS
- Blue ring applicator for 1-3mm applications……………………………………………………………………………………………………………………………………S-HO-CCXP-MA-005
- Grey ring applicator for 2-4mm applications…………………………………………………………………………………………………………………………………..S-HO-CCXP-MA-006
- Green ring applicator for 3-5mm applications………………………………………………………………………………………………………………………………..S-HO-CCXP-MA-007
- Yellow ring applicator for 5-8mm applications………………………………………………………………………………………………………………………………S-HO-CCXP-MA-008
- The above list of products is correct at the time of printing. Some articles may no longer be available when reading
- this document. Some articles may not be available in certain countries.
- CryoPen® is the registered trademark of H&O Equipments nv/sa for Europe, the Middle East, Africa and Asia Pacific.
- CryoPen® is manufactured by H&O Equipments nv/sa.
- FDA certificate is available and can be obtained upon simple request.
- EC Declaration of Conformity and EC certificate are available and can be obtained upon simple request.
Device classification
CryoPen is a non-invasive, non-sterile, reusable medical device.
Intended Use
CryoPen is dedicated for the cryogenic treatment of the following benign skin
lesions : Acrochordon, actinic keratosis and cheilitis, capillary haemangioma,
cutaneous leishmaniasis, discoid lupus erythematosus, filiform, flat, vulgar,
plantar and anogenital warts, rosacea, lichen sclerosus, granuloma annulare,
molluscum contagiosum, seborrheic keratosis, viral lesions by dispensing an
extremely precise flow of nitrous oxide applied directly on the lesion.
All mentioned products are manufactured in the European Community by,
H &O Equipments nv/sa
Rue des Journaliers 1, 7822 Ghislenghien, Belgium
- Telephone: +32 68 26 86 00
- Fax: +32 68 55 28 48
- E-mail: info@ho-equipments.com
- Website: www.ho-equipments.com
This manual’s version : Manual_CryoPenXP-XPS_20230531.
Attention! Reference is made to the liability waiver at the back of this manual.
USED SYMBOLS
IMPORTANT NOTICE
- When used correctly, the device does not come into contact with the lesion nor the skin.
- When used normally, there is no need to perform any maintenance, cleaning or disinfection.
- Never clean the thread of frontend and backend. The existing coating should be protected.
- 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 gently manipulate all components of CryoPen instruments. Never use more than gentle hand force. Never use pliers or other tools to manipulate the instrument.
- Please ensure to only use the cartridges and filter/openers supplied from H&O Equipments nv/sa. Any other cartridges and filter/openers would damage the instrument.
- Incorrect placement of the filter/opener device into the loading cavity will cause irreversible damage to the instrument.
- Residual foreign matters in the loading cavity while placing a new filter/opener can cause instrument failure.
- When loaded, the instrument is under high pressure. Any change to the construction of the instrument may cause a potential risk.
- Never put your hand on the gas release opening at the end of the backend while removing the cartridge!
- All external parts can be wiped with a cloth soaked in any noncorrosive disinfecting solution. Never immerse the entire instrument in a disinfecting solution.
- The applicators must be kept away from dust and the cartridges must be kept away from high temperatures (min -30°C/-22°F and max 50°C/122°F). Leave the applicator cap on when not in use.
- The CryoPen should be handled with care. When storing the instrument with a loaded cartridge in its case, position the CryoPen in such a way that the trigger cannot be pressed when closing the lid of the case. This would cause undesired gas flow.
- CryoPen instruments are intended for professional use only.
- The N2O cartridges contain both a liquid and a gaseous phase in balance. The proportion of each phase depends on the room temperature which affects the output flow. The best performances are achieved when the cartridge temperature is between 19°C and 22°C (66°F and 72°F). Lower and higher temperatures will give different values of pressure and density of the cryogen. Over 25°C/77°F, the quantity of liquefied N2O in the CryoPen jet will decrease.
- Empty cartridges should be discarded as metal scrap.
Contraindications
- Unstable diabetes
- Skin conditions, e.g. skin tumors, esanthema, open wounds, solar hyperkeratosis
- Unexplained, suspicious liver spots and moles
- Cancer tissues and malignant tumors
The 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
Reduce 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. Avoid freezing the basal cell layer where melanocytes (pigment producing cells) are located.
- Sensory impairment. Though rare, damage to nerves is possible, particularly in areas where they lie closer to the surface of the skin, such as the fingers, the wrist, and the area behind the ear. Reports suggest this will disappear within several months.
- Spattering of the cryogen during spraying, when the end nozzle freezes. The innovation of CryoPen is the direct application of nitrous oxide under high pressure (49-53 bar for a cartridge temperature of 66-72°F/19-22°C). This high pressure jet may cause minor shards of frozen humidity in the air blown away in a circle of approximately 30cm of diameter. They will thaw the moment they would eventually touch healthy skin.
- Hair loss. Hair follicles are easily damaged by cryosurgery and permanent hair loss is not uncommon.
Further side-effects
- Edemas
- Bleeding
- Pain and syncope
- 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
Interact with your patients
Inform patients that there will 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 when you manage to avoid treatment of healthy
tissue. The ice will reach the caudal extent of the lesion after a given
amount of time related to the depth of the lesion. From that moment the
patient will experience a pain sensation. This may be the moment to stop
treatment. You may eventually add a few seconds more depending on the
patient’s comfort level and upon the clinical evaluation of the operation.
There might be a little residual stinging for a few minutes after treatment.
Occasionally, a blister might form and persist for a few hours.
USING THE INSTRUMENT
Step 1 Load a new cartridge
The cartridges are packed in peel-pack blisters with an assembled
filter/opener included. The filters are used for protection of the applicator,
the opener for puncturing the cartridge. CryoPen XPS can be used with 8g N2O
cartridges only. CryoPen XP can be used with 16g N2O cartridges and with 8g
N2O cartridges, thanks to the converter 16/8g. Ensure that the cavity is empty
of any remaining parts. Open the peel-pack. Take out the filter/opener with
the tweezers. Hold the CryoPen’s tip end pointed downward. Place the
filter/opener in the instrument and make sure that it is seated flat at the
bottom of the loading cavity.
The trocar of the opener should be pointed upward! Take the cartridge and put
it into the cavity with the narrow side down, on top of the filter/opener.
Step 2 Puncture the unused cartridge
Gently screw the CryoPen’s backend onto the frontend. Go to the point where
you feel that the contact between the assembled filter/opener and the
cartridge is established. Now, position your hands so that the last turn will
be in an uninterrupted movement. Now, rotate quickly until you feel that the
end of the rotation is achieved. You may eventually hear a short hissing
sound. The shorter the hiss, the better!
Discharge the used cartridge & empty the cavity
Before loading a new cartridge, first release any unused gas from the current
cartridge by unscrewing the applicator followed by pressing the trigger. Then
unscrew the backend. Discard the used cartridge and filter/opener. Regarding
CryoPen XP be careful not to throw away the converter 16/8g. Ensure that the
used filter/opener does not remain inside the cavity. You should have the
cavity empty of any remaining parts.
Step 3 Use your CryoPen
Remove the applicator cap. Gently squeeze the trigger to start the flow of
N2O. Release the trigger to close off the flow of cryogenic liquid. 1 or 2
seconds after releasing the trigger, the remaining gas in the applicator is
discarded. A cartridge can be used for several treatments and
patients.
SELECT YOUR APPLICATORS
Applicators with various flow rates are available depending on the lesion
size. Ask your distributor or check on www.ho-equipments.com. The table below gives the estimated application with a
continuous flow time depending on the applicator and the cartridge size. The
measurements were performed between 19°C/66°F and 22°C/72°F.
Position the CryoPen for treatment
The instrument must be held vertically with the tip directed downward. An
angle of less than 45° must be avoided.
Effective application
Before starting treatment take into account age, location, size and the number
of lesions, skin type, degree of tanning and season. The applicator tip (from
where the liquefied N2O flows) should be held 0,5 to 3 mm from the lesion.
Further than 5 mm from the applicator tip the liquefied N2O will have expanded
into gas phase which is not effective for achieving therapeutic results. By
approaching the lesion with the gas flowing you will observe the focal point
of the jet on the tissue. The closer you approach the lesion, the more
freezing power you 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. Condensation of humidity in the air may in some cases create an
ice field on top of the lesion. This ‘igloo of ice’ will hinder the effective
working of the liquid phase of the cryogen (at -89°C/-128°F) and should be
removed. The learning curve for utilizing the CryoPen is short. CryoPen
provides the possibility to have full control in the application of freezing
power. Start practicing on the regular lesions and treat the more delicate
ones after having acquired some experience.
Duration/Depth of the treatment
Hold the tip of the applicator as close as possible to the lesion. In all
literature, the rapid drop of temperature (thermal shock) is described as a
critical criterion. However, always relates to the part of the body where the
operation is applied. In some parts, skin is thinner which 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.
For general purposes, most lesions take about 2 to 30 seconds. The duration of
the treatment will depend on the surface and the thickness of the tissue being
treated. Thickness must be estimated based on clinical experience. After the
first freezing cycle, the tissue should be allowed to thaw for about 30
seconds followed by a second freeze. Note that the tissue will freeze faster
than during the first freezing cycle. This ‘freeze-thaw-freeze’ technique
offers the best opportunity for success. You will find this procedure in most
literature on cryotherapy. A follow-up visit is recommended after 2 to 4 weeks
to confirm that all pathological tissue has disappeared and check if follow-up
treatment is necessary.
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 an operator. H&O Equipments nv/sa 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 CryoPen, its design, specifications, possession and use, and treatment procedures, and whether or not any such death, injury, loss, damage(s) result from the negligence, default or error in judgment by H&O Equipments nv/sa, their affiliates, respective directors, officers, shareholders, employees, agents and contractors, and even if advised of the possibility of such damages. You agree to indemnify H&O Equipments nv/sa, their affiliates, respective directors, officers, shareholders, employees, agents and contractors, from and against any 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 hereinbefore referred to.
- For more information visit our website: www.ho-equipments.com
References
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