H&O Equipments CryoPen B+ User manual

User Manual

Table of contents
User manual 3-17
Notice explicative 18-32
Gebrauchsanweisung 33-47
Gebruikershandleiding 48-62
Instrucciones de uso 63-77
2

The serial number is engraved in the cavity.
Please mention your instrument’s serial number
in all communication with H&O Equipments.
Cartridge
Frontend
Trigger
Applicator
Applicator cap
Filter/opener
Cavity
Trocar
SN
User manual
3

REF
This user manual is applicable
for the following products and accessories.
Instruments - Lifetime of the CryoPen B+ : five years from the purchase.
With orange/red, white/red, green/red applicators
Cartridges - Expired date on the cartridges packaging (shelf life two years).
23,5g N2O cartridges: 1 carton of 12 boxes
each box containing 6 cartridges
Applicators
Orange/red dot applicator for 1-4 mm applications
White/red dot applicator for 2-6 mm applications
Green/red dot applicator for 4-8 mm applications
Accessories
Tweezers for filter/opener placement
Locking cap for applicators
CryoPen B+
S-HO-CBPLUS-05
S-HO-NO23-12-S06
S-HO-CCX0-MA-027
S-HO-CCX0-MA-005
S-HO-CCX0-MA-006
S-HO-AXXX-FO-001
S-HO-APPL-CAP
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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.
EC or Canadian Declaration of Conformity is available and can be obtained upon simple request.
CryoPen® is manufactured by H&O Equipments nv/sa.
FDA certificate is available and can be obtained upon simple request.
CryoPen instruments are intended for the controlled destruction of unwanted tissue by application
of extreme cold using liquefied N2O. Pathological indications are benign skin lesions such as:
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.
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The most recent version of this user manual and other language versions can be downloaded on our website.
Attention! Reference is made to the liability waiver at the back of this manual.
All mentioned products are manufactured in the European Community by:
Used symbols
Manufacturer
Caution, consult accompanying documents
Consult the user’s guide
Do not expose the cartridges to temperatures
above 50 °C/122 °F.
50°C
/122°F
Keep away from sunlight
Catalogue number
Serial number
Batch number
Use-by date
Notified body nr 1639 SGS BELGIUM
REF
SN
LOT
H&O Equipments nv/sa, Rue des Journaliers 1,
7822 Ghislenghien, Belgium
Telephone: [phone]
Fax: [phone]
E-mail: [email protected]
Website: www.ho-equipments.com
This manual’s version: 191125CBPE
6

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.
• Should the applicator touch the patient in case of misuse, the applicator can be cleaned (autoclaved: 134 °C/273 °F - 4min 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).
• Read the security instructions and remove the information taf from the instrument body.
• 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 filter/opener supplied with the N2O cartridges. Any other filter/opener 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 opening 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. Only the applicators can be autoclaved.
• The applicators and the cartridges must be kept away from dust and high temperatures. Leave the 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 switch cannot be depressed 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
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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
temperature which affects the output flow. The best performances are archieved when the cartridge temperature
is between 19 and 22°C (66 and 72°F).
• Empty cartridges should be discarded as metal scrap.
8

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 (50-55 bar). 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.
• Pigmented spots. It is common use to not treat pigmented spot 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.
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• Post-inflammatory hyperpigmentation (PIH) is a frequent concern when treating SL in darker skin types.
Cryotherapy using CryoPen is a simple and practical therapy for SL considering the following instructions:
1- Select your candidate: A typical candidate for treatment has multiple, brown, well defined, small
and homogenous color lesions with no history of significant post-inflammatory hyperpigmentation.
2- Perform a spot test by treating one lesion, and evaluate the result in three weeks.
3- Apply sunscreen and use whitening cream for darker skin types for 3 weeks before and after treatment.
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
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Empty loading cavity
Blistered cartridge and
assembled filter/opener device
Step 1 I Empty the loading cavity
Before loading a new cartridge, release any unused gas from the used
cartridge by unscrewing the applicator tip followed by pressing
the button. Discard the used cartridge. Please ensure that the used
filter does not remain inside the cavity.
Important note:
In the case that you would not follow the gas release procedure
as described before, the discharge of the gas will pass through
the small opening under the on/off button. Extreme attention should
be paid to avoid directing the jet of escaping gas to the user’s hands,
face or any other unprotected body parts. Never cover this opening!
Never put your hand on this opening while removing the cartridge!
This action must be done in a well ventilated room and by preference
at an open window.
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Step 2 I Load a new cartridge
The cartridges are packed in peel-pack blisters with an assembled filter
and cartridge opener included. The filters are used for protection
of the applicator. The opener punctures the cartridge.
CryoPen B+ can be used with 23,5g cartridges only. Ensure that the
loading cavity is empty of all residue.
Open the peel-pack. Take out the filter/opener with the tweezers.
Hold the CryoPen’s tip end pointed downward. Place the filter in the
instrument and make sure that it is seated flat at the bottom
of the loading cavity.
Step 3 I Puncture the unused cartridge
Gently slide the cartridge into the CryoPen’s loading cavity and
start screwing the cartridge turning it clockwise in a quick and
uninterrupted movement until hand-tight.
Installation of the assembled filter/opener device
12

Step 4 I Use your CryoPen B+
Remove the applicator cap. Gently squeeze the trigger switch to start
the working. Releasing the trigger will close off the flow of cryogenic
liquid. You may observe that during 1 or 2 seconds after releasing
the trigger, the remaining gas in the applicator is discarded.
Applicators with various flow rates are available. Ask your distributor
or check on www.ho-equipments.com.
23,5g Lesion size Power
Orange/Red 375-400 s 1-4mm
White/Red 200-250 s 2-6mm
Green/Red 150-170 s 4-8mm
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OK!
Position the CryoPen
correctly
OK!
OK!
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 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 4 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.
Do not hold the CryoPen applicator still above the lesion.
It may flood the area and damage healthy tissue surrounding the lesion.
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This can cause blisters and pain to patients.
Condensation of humidity in the air on the frozen field of the lesion during operation 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 with the applicator tip.
After thawing, the tissue turns reddish and has the aspect of a zone of inflammation due to interstitial bleeding.
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 essential criterion. However, always relate 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 time will
depend on the surface area 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 up visit is recommended after
2 to 4 weeks to confirm that all pathological tissue has disappeared or that a follow-up treatment is necessary.
15

Interact with your patients
Inform patients that there will be a pain sensation similar to a ballpoint being pushed into the skin. Generally,
little or no discomfort is experienced during the first few seconds when you manage to avoid teratment
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.
There might be a little residual stinging for a few minutes after treatment.
Occasionally, a blister might form and persist for a few hours.
16

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 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 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 hereinbefore referred to.
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Cartouche
Extrémité antérieure
Gachette
Applicateur
Capuchon de l’applicateur
Filtre/perforateur
Cavité
Trocart
Le numéro de série est gravé dans la cavité.
Attention de mentionner le numéro de série
de votre intrument dans toutes vos communications
avec H&O Equipments.
SN
Notice explicative
18

REF
Instruments - Durée de vie du CryoPen B+ 5 ans après achat.
Avec applicateurs orange/rouge, blanc/rouge, vert/rouge
Cartouches - Date d’expiration sur l’emballage des cartouches (durée de conservation 2ans).
Cartouches de 23,5g de N2O: 1 carton de 12 boîtes
contenant chacune 6 cartouches
Applicateurs
Applicateur orange/rouge sur lésions de 1-4 mm
Applicateur blanc/rouge sur lésions de 2-6 mm
Applicateur vert/rouge sur lésions de 4-8 mm
Accessoires
Pincette pour positionnement du filtre/perforateur
Capuchon pour applicateurs
S-HO-AXXX-FO-001
S-HO-APPL-CAP
Ce manuel de l’utilisateur concerne les produits et accessoires suivants: CryoPen B+
S-HO-CBPLUS-05
S-HO-NO23-12-S06
S-HO-CCX0-MA-027
S-HO-CCX0-MA-005
S-HO-CCX0-MA-006
19

La liste des produits est exacte au moment de l’impression. Certains articles peuvent ne plus être
disponibles lorsque vous lirez ce document. Certains articles peuvent ne pas être disponibles dans
certains pays.
CryoPen® est une marque déposée de H&O Equipments nv/sa pour l’Europe, le Moyen-Orient,
l’Afrique et l’Asie-Pacifique.
CryoPen® est fabriqué par H&O Equipments nv/sa.
La certification FDA est disponible et peut être obtenue sur simple demande.
La déclaration de conformité CE et le certificat CE sont disponibles et peuvent être obtenus
sur simple demande.
Le CryoPen est un dispositif médical réutilisable, non invasif et non stérile, consacré au traitement
cryogénique des lésions cutanées bénignes suivantes : acrochordon, kératose et chéilite actiniques,
hémangiome capillaire, leishmaniose cutanée, lupus érythémateux discoïde, verrues plantaires et
ano-génitales filiformes, plates, vulgaires, rosacée, lichen scléro-atrophique, granulome annulaire,
molluscum contagiosum, kératose séborrhéique et lésions virales en appliquant un flux extrêmement
précis de protoxyde d’azote directement sur la lésion.
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