The product surface may become hot or cold if exposed to external sources
of heat or cold, such as sunlight or frost ⸀
Any serious incident that has occurred in relation to the product should be
reported to the manufacturer and the health authorities ⸀ A serious incident
is defined as an incident that leads to the death of a patient, user, or any
other person, or causes a temporary or permanent deterioration in the
person's health ⸀ Any incident that has resulted in or has the potential to
result in a serious incident must be reported ⸀
Contraindications for use
If the product is being used for patients with damaged skin, wounds, or other
en
similar conditions, it is recommended to use a towel as a barrier to prevent
open wounds from coming into direct contact with the substrate ⸀
Biocompatibility
The biocompatibility of the materials that come in contact with the user's
skin during the intended use has been evaluated according to the procedures
outlined in DS/EN ISO 10993-1:2020, which involves assessing the materials
for harmful substances ⸀ Based on this evaluation, the materials are considered
suitable for their intended use ⸀
Flammability
The product materials have undergone flammability testing in accordance
with ISO 8191-1:1987 and ISO 8191-2:1988 ⸀
16
CAUTION
!
NOTICE