INFORMATION - pag. IN 7
Safety
Guarantees about safety and hygiene
If COMPACT is used properly and according to the instructions supplied by
GAMMA, it will not cause hazards for operators. GAMMA decline responsibility for
any damages which may be caused to persons or things due to an improper use
of the trolley.
Using spare parts different from those supplied by the manufacturer may cause
damages to people or to the trolley.
•
COMPACT
is safe. It is in line with the highest safety standards thanks to the
materials used, to its rounded shape, to the absence of sharp metal parts and to the
attention paid to the fitting of all the accessories.
•
COMPACT
is innovative. It was manufactured with state-of-the-art materials, such
as rigid polyurethane Baydur
, which is unchangeable with time, resistant to
chemical agents, not subject to corrosion and auto extinguishing.
•
The solutions adopted for the design and manufacture of the trolley comply with all
safety principles, considering the technological achievements universally
recognised.
•
During the design and manufacturing processes, risks were eliminated or reduced
as much as possible (implementation of safety in the design and manufacture of the
trolley) and the necessary protection measures were adopted against those risks
that could not be eliminated.
•
Users are informed on residual risks. For instance, in the case of components
and accessories that have to support a load (such as I.V. poles or drawers)
the maximum allowable load is indicated both in the corresponding card and
on the component itself. If the label is damaged or becomes unreadable, it is
necessary to replace it.
•
Materials were chosen on the basis of their reduced toxicity and flammability.
•
Considering the intended use of the trolley, attention was paid also to the mutual
compatibility between materials and fabrics, biological cells and body fluids.
•
The trolley was designed so as to reduce as much as possible all risks due to the
accidental leakage of substances in the trolley (considering the trolley itself and the
characteristics of the environment it is to be used in)
•
The trolley was designed, manufactured and packed in such a way that its features
and its performance
– considering its intended use – are not subjected to alteration
during storage and transportation.
•
The normal stress the trolley is subjected to under normal usage conditions does
not alter the features and performances described in this document; therefore, the
clinical condition of patients, their safety and the safety of third persons cannot be
jeopardised (during the device’s lifecycle)
•
The distinguishing features of the materials used do not change when they come
into contact with human body fluids or other fluids (especially as far as flammability
is concerned); therefore, safety is guaranteed with all substances and materials that
come into contact with the trolley during normal use (or maintenance)
•
It is necessary to report any major accident occurring in relation to the
devices to the manufacturer and to the competent authority of the Member
State in which it is established.
•
COMPACT
was designed and manufactured in compliance with the following
standards and decrees:
•
the device comply with the general safety and performance requirements of
Regulation (EU) 2017/745 (MDR) Annex I,
•
the manufacturing company is certified according to UNI EN ISO 9001 and UNI
CEI EN ISO 13485.
