Intended Use; Adverse Effects; Intended Target Groups; Indications - Cortex Cryopro Gebrauchsanweisung

EN - CRYOPRO® INSTRUCTIONS FOR USE
TABLE OF CONTENT
Intended use ...................................................................................................... Page 43
Adverse effects ................................................................................................. Page 43
Intended Target Groups............................................................................... Page 43
Indications ........................................................................................................... Page 43
Contraindications ............................................................................................ Page 43
Warnings .............................................................................................................. Page 43
Filling the unit ..................................................................................................... Page 44
Accessories ........................................................................................................ Page 44
Operating Principles ...................................................................................... Page 44
Treatment/Clinical application ................................................................. Page 44
Decontamination ............................................................................................. Page 44
Storing ................................................................................................................... Page 45
Maintenance ...................................................................................................... Page 45
Disposal ................................................................................................................ Page 45
Performance Characteristics ................................................................... Page 45
Explanation of symbols ................................................................................ Page 45
Accessories ........................................................................................................ Page 46
Recommended treatment times ............................................................. Page 47
Cleaning and sterilization of CryoPro® contact probes ............ Page 48
The CryoPro® is an active non-implantable medical device for cryo-
surgical treatment of skin lesions by tissue freezing. The CryoPro® device
is intended to be filled with liquid nitrogen (LN2). On activation, the LN2
is ex-pelled through an immersion tube to the tip of the device where
various spray apertures or contact probes can be attached.

INTENDED USE

The CryoPro® is a handheld device for cutaneous cryo-surgery that
uses localized appli-cation of liquid nitrogen to treat skin lesions by tissue
freezing. Treatment can be performed using open spray or contact probe
techniques by healthcare professionals such as dermatologists, family
physicians, and nurses trained in cryosurgery in a normal well-lit and
ventilated clinical setting.
The use of cryosurgery is well tolerated, fast, easy to apply, and without
systemic side effects.

ADVERSE EFFECTS

Temporary adverse effects;
• Pain during and/or shortly after treatment, bulla formation and local
edema are the major temporary adverse effects.
Long term complications;
• In some cases, the patient may develop lesional hypopigmentation
and/or peripheral hyperpigmentation. Risk of permanent
hypopigmentation is higher in dark-skinned persons.

INTENDED TARGET GROUPS

The device can be used for all groups of patients regardless of age,
gender and race. However, infants as well as dark skinned people not
willing to accept pigment changes, are excluded.

INDICATIONS

The CryoPro® is indicated for the following benign skin lesions:
Acne, dermatofibroma, hemangioma, hypertrophic
seborrheic keratosis, myxoid cyst, pyogenic granuloma, skin tag, solar
lentigo, and viral warts (anogenital, common, flat, mosaic, plantar).
Several premalignant/malignant lesions may also be treated using
cryotherapy:
Actinic keratosis, basal cell carcinoma (BCC), Bowen's disease,
squamous cell carcinoma (SCC).
The CryoPro® should NOT be used outside of the above-mentioned
indications.

CONTRAINDICATIONS

• BCC/SCC lesions with high risk features
• Lesions where pathology is needed
• Previously experienced sensitivity to cryosurgery
• Immunosuppression
• Impaired vascular supply
• Anticoagulant use
• Treatment on areas above prominent bones
or superficial nerves
• Tumors with indefinite margins
• Not willing to accept pigment changes
(higher risk in dark-skinned people)
• Infants
• For patients with psoratic arthritis, cryosurgical treatment
may in rare cases be a trigger for flaring.
For aditional information about contra-indications, please see relevant
literature, e.g. Clebak KT et al. Cutaneous Cryosur-gery for Common Skin
Conditions. Am Fam Physician. 2020 Apr 1;101(7):399-406.

WARNINGS

• Do never use the CryoPro® unit without either a spray aperture or
contact probe in place. The excessive amount of liquid put out if the
unit is used without an attached spray or probe may cause severe
damage to the patient. A Flow Restrictor (accessory) can be affixed
to prevent nitrogen flow if a spray aperture or contact probe is not in
place.
• After filling, the lid must be mounted 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. The burst of outflowing nitrogen may hit the hand of the
user and/or the patient.
• Do not use the unit if the pressure relief valve is blocked or have been
tampered with or the unit is otherwise damaged. This may cause
excessive pressure and violent release of nitrogen, exposing both
patient, user and other persons to danger.
• The unit may get cold (visible ice on lid and spraytube) after prolonged
use. Leave the unit to thaw before resuming treatment.
• Be aware of signs of insulation failure - the bottle will freeze over.
DO NOT USE if the bottle is covered with ice.
• Be careful when opening a pressurized unit. Open the lid slowly. The
unit may still be pressurized even if no residual liquid is left.
• DO NOT spray on open wounds, into body orifices, or into the eyes.
• Only use liquid nitrogen in a well ventilated room. Evaporated nitrogen
may cause asphyxiation.
• Do not use contact probes with signs of a compromised surface.
Scratches or loosening of the surface coating may bring the patient
into contact with underlaying materials or debris.
• Do not use the CryoPro® unit if there are signs of severe transport
damage or unintentional opening of the packaging before first use.
• Gloves, goggles, and suitable protective clothing should be worn
during the cleaning process.
• Failure to remove contaminants from the surface of the
contact probe could compromise the correct functioning, its safe use,
and the subsequent sterilization process.
• The CryoPro® is a medical device intended for professional use
scar, keloid, only. When not in use it must be kept out of reach of children and
unauthorized personnel.
• When using a contact probe, the sili-cone vent tube, which is attached
to the base of the contact probe, must be directed away from the
patient or user until hardened.
This will happen approximately 5 seconds after activating the liquid
nitrogen flow and the tube will remain in a fixed position (frozen) during
the remainder of the procedure.
NB: Any serious incident that occurs in relation to the device must be
reported to the manufacturer and the relevant competent authority of
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