Berlin Heart EXCOR Adult, Instructions For Clinical Use

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Safety Information
en
WARNING
WARNING
Have an EXCOR Active or an Ikus on hand in the hospital at all times
as a backup. Medical personnel must be trained in the use of the back-
up system. Medical personnel must be available in the hospital at all
times.
4.3 Caregivers
Patients who are not physically or mentally capable of operating
EXCOR Active correctly, or patients who do not understand how to use
the system safely, must be supervised at all times. This also applies to
patients who have not yet received EXCOR Active training.
4.4 Ambient Conditions
Do not operate EXCOR Active in ambient conditions under which
heavy condensation could form! In particular, avoid transitions from
very cold to humid and warm.
Avoid extreme fluctuations in temperature.
Before commissioning of EXCOR Active, the system must have adapt-
ed to the ambient temperature. This applies, for example, after trans-
portation or storage in different temperatures. Otherwise, condensation
could form. Water condensation can damage electrical and pneumatic
components. As a result, the safe and smooth operation of EXCOR
would not be guaranteed. Follow the instructions in section 20.9.3:
Transport Conditions and Long-Term Storage Conditions, page 193
Observe the minimum and maximum ambient temperatures for the
components of the
EXCOR Active system. If these warnings are not
heeded, safe and proper operation is not guaranteed. Possible conse-
quences could be the failure of components due to overheating, or loss
of functionality due to low temperatures. For information on ambient
temperatures, see section 20.9: Ambient Conditions, page 192.
Do not expose the electrical components to direct radiant heat, e.g., in-
tense, direct sunlight or positioning directly beside a heater. Do not cov-
er the air vents on the driving unit or the battery charging unit. If there
is poor ventilation, heat will accumulate.
If component temperatures exceed permitted thresholds, it could result
in functions failing.
Electrical components that are not protected from penetration of spray
water must be protected from moisture. The IP protection type indi-
cates the device’s degree of protection against the ingress of liquids.
For information on IP protection types, see chapter 20: Technical Spec-
ifications, page 187.
Do not operate EXCOR Active in an oxygen-enriched environment (ox-
ygen percentage above 25%)! Otherwise there will be a greatly in-
creased risk of fire.