Safety & instructions for use

CryoSuccess is a medical device for qualified healthcare professionals. Patients must be informed of possible risks before treatment. Use only as described in the Instructions for Use, and only for the intended use.

Due to limited long-term data in infants and newborns, use in these patients only after careful medical assessment.

• Always wear gloves and safety glasses during use and cartridge changes.
• Use only original CryoSuccess cartridges and parts. Never modify the device.
• Do not use dropped, damaged, or improperly stored devices — have your distributor inspect them first.
• Never use force when attaching cartridges; always screw straight into the thread.
• Only unscrew completely empty cartridges. A brief hiss indicates residual gas — not dangerous.
• Keep the device and cartridges out of reach of children.
• Report serious incidents to the manufacturer and your competent national authority.

Cryosurgery should be avoided in cases of:

• Blood dyscrasias of unknown origin
• Cold intolerance, Raynaud's disease, cold urticaria, cryoglobulinaemia
• Pyoderma gangrenosum, collagen and autoimmune disease
• Unstable diabetes, exanthema, open wounds

For basal-cell carcinoma, treat only small, well-defined, primary, superficial or nodular BCCs in low-risk body areas.

• Pain, oedema, blister and bullae formation are expected.
• Temporary hyperpigmentation is relatively common and may last several months to over a year.
• Temporary milia occasionally occur after deeper cryosurgery for malignancies.
• Temporary scar formation is inevitable after deeper freezing; healing is usually cosmetically acceptable.

Body part: clean and disinfect with Gigasept Instru AF or 70 % ethanol. Never sterilize the body part.

Tips: clean with disinfectant or 70 % ethanol, brush, rinse with demineralised water, wipe dry. Inspect glass tips for damage and discard if broken.

Sterilization: wrap and autoclave (steam) at 134 °C for 18 minutes. Hot air and other non-steam methods can damage the tip and must be avoided.

All cleaning, disinfection and sterilization is manual. Always wear gloves. Country-specific regulations take precedence where they differ.

• Protect from heat, flames and sunlight.
• Storage temperature range: −30 °C to +50 °C.
• Never expose cartridges to temperatures above 50 °C.

Dispose of materials in compliance with local regulations. Cartridges must be emptied before disposal — empty cartridges may be disposed of as scrap metal. Contaminated tips must be cleaned before disposal.

• Refrigerating method: open system ("Liquidfreezing")
• Cold performance: −89 °C (constant)
• Body: brass and stainless steel, gold-plated, dosing valve-lever, safety filter in cartridge holder
• Tips: gold-plated metal and borosilicate glass
• Cartridge: 23.5 g N₂O, internal pressure 50 bar, integrated safety valve

CryoSuccess meets EU Regulation 2017/745 for medical devices; conformity assessed by DQS (NB 0297). The device is also registered with the U.S. FDA and participates in MDSAP. Manufactured under ISO 13485:2016.