8
2
SAFETy INSTRUCTIONS
2
SAFETy INSTRUCTIONS
2.1
PROPER USE
The unit is intended exclusively for cooling or heating
the water that is pumped during use of the unit through
an attached oxygenator to regulate the temperature of
the patient’s blood. Any other form of use is regarded as
improper.
The unit must only be operated with its associated
components and a oxygenator in accordance with the
instruction manual.
Proper use also includes following all the instructions in
this manual and performing all inspection and servicing
work in due time.
Claims of any kind relating to damage resulting from
improper use shall be excluded.
The risk shall be borne exclusively by the operator.
CAUTION
Danger due to improper use!
Improper use and/or any other type of
use could put the patient and/or user at
risk.
2.2
REQUIREMENTS OF PERSONNEL
WARNINg
• To ensure patient safety, the unit
should be monitored continuously
during operation.
• The product may only be used on
the instructions of a doctor, under
medical supervision and only by
medically-trained personnel (e.g. car-
diovascular technician/doctor/critical
care staff).
• Only persons whose training and
qualifications entitle them to do so
should work on/with the unit. They
must also be instructed to do so by
the operator.
• Personnel being trained, taught or
instructed, or taking part in a course
of general training, may only operate
the unit under the supervision of an
experienced person.
WARNINg
• Persons under the influence of drugs,
alcohol or medication affecting the
response capacity must not use this
device.
• The device may cause dangers if used
improperly by untrained staff.
• In addition to the instructions for use,
the general legal and other contractu-
al regulations for accident prevention
and environmental protection as
well as essential health and safety
requirements must be observed.
The operator must instruct the staff
accordingly.
