Safety & compliance

Safety, by design.

Cool Gel Pad protection, RFID-controlled applicators and validated protocols — with a transparent view of contraindications, warnings and side effects.[4]

Contraindications

When not to treat.

Cold-associated disorders

Cryoglobulinaemia, paroxysmal cold haemoglobinuria, Raynaud's disease and similar conditions.

Warnings

Treat with medical authorisation.

In certain cases treatment may be authorised under medical supervision. The doctor must authorise treatment when conditions such as the following are present:[4]

  • Dermatological treatments, wounds or active lesions in the area

  • Altered vascular circulation; blood disorders or anticoagulants

  • Skin sensitivity or neuropathies

  • Recent surgeries, scar tissue, hernias

  • Implanted devices (e.g. pacemakers)

Pregnancy & lactation

Treatment is contraindicated during pregnancy and while breastfeeding.

  • Poorly controlled chronic diseases; infectious diseases

  • Autoimmune diseases; immunosuppression

  • Malignant pathologies; history of hyperplasia

  • Corticosteroid treatments; psychiatric disorders

  • Allergy to Cool Gel Pad; obesity (BMI > 30

Side effects

Temporary, and openly stated.

Frequencies classified per CIOMS / EMA.[5] Most conditions are temporary and resolve over a few days or weeks — contact a specialist doctor if symptoms feel different or more severe.

During & immediately after

Very frequent: cold-related numbness, pulling; redness & inflammation; muscle spasms

Frequent: vasovagal symptoms; local pain

Infrequent: thermal injuries; allergic reaction to gel compounds

From 24 hours onwards

Very frequent: local pain; paraesthesia; haematomas; redness; mild inflammation

Frequent: skin pigmentation disorders

Infrequent: paradoxical adipose hyperplasia, nodules

Very unusual: submental motor-nerve disorders

References & notes

  1. Refer to the Instructions for Use (IFU) and user manual for the complete list of indications, contraindications, warnings and side effects. Indications, intended use and regulatory approvals may vary by country. In certain cases treatment may be authorised under medical supervision.

  2. Side-effect frequencies classified in accordance with CIOMS (Council for International Organizations of Medical Sciences) and the EMA (European Medicines Agency), as presented in Cooltech Define product documentation. Most side effects are temporary and resolve over a few days or weeks.