claros pico user manual V 2.1
page 14 of 34
5.2
Mutual interference risks
No mutual interference risks arise during use because combination with other medical products is not envisaged.
»
Hazard due to energy: caused by electricity, heat, mech. force, non-ionising radiation, electromagnetic fields,
moving parts and acoustic pressure
Minimal risk 1
» Biological hazards: caused by bio-burden, bio-incompatibility, incorrect supply (substance, energy), toxicity,
infection, pyrogenicity and decomposition of material
Minimal risk 1 (when appropriate suction is used)
»
Environmental hazards: caused by electromagnetic interference, inadequate energy supply (excess voltage or
undervoltage), limited cooling, operation outside prescribed environmental conditions, incompatibility with other
devices, accidental mechanical damage and contamination with waste products
Minimal risk 1
»
Hazards associated with device use: caused by inadequate labelling, insufficient instructions for use, insufficient
accessory specifications, over-complicated instructions for use, instructions for use that are not available or have
become separated, untrained staff, insufficient warning of side-effects, incorrect measurements and other
technical measurement aspects, misdiagnosis, incorrect data transfer, misinterpretation of results and
incompatibility with consumables and other products
Low risk 1
»
Hazards due to malfunctions, maintenance and ageing: caused by insufficient performance features for planned
use, inadequate maintenance, lack of appropriate assessment as to when the device's service life will expire, loss
of mechanical integrity, substandard packaging (contamination) and unsuitable reuse
Low risk 2
1.
Definition of
"minimal risk"
:
Risks of identified hazards are assessed as "small" when, if one or more of the hazards specified arises, the extent
of injuries caused by the product to the user, patient or individuals in the immediate vicinity, both during intended
use and in the event of error, is so small that it is not expected to result in health impairment and/or physical harm
or detriment of any sort to the above individuals.
2.
Definition of
"low risk":
Risks of identified hazards are assessed as "low" when, if one or more of the hazards specified arises, the extent
of injuries caused by the product to the user, patient or individuals in the immediate vicinity, both during
intended use and in the event of error, is so low that it is not expected to result in any permanent or long-term
health impairment and/or physical harm or detriment of any sort to the above individuals.
Vasoconstrictors do not need to be used when administering local anaesthetic for invasive procedures. This is
particularly the case when treating pregnant patients or those with pre-existing cardiac problems.
