Berlin Heart EXCOR Pediatric VAD, Manual, Page: 30 / 250

Chapter 1 Important safety information
1.2.4 Transport outside the clinic
CAUTION
The crate may only be transported as described in section 6.7:
Transportation and packaging, page 84. Do not tilt or overturn the Ikus
when it is packed inside the transport crate. Otherwise there is a risk
that the Ikus is damaged or destroyed.
Always observe a resting period of 6 hours after each transportation
before switching on the Ikus! The temperature of the Ikus should get
adapted to the ambient temperature.
Keep all driving tube connectors covered at all times when not in use.
Also refer to section 6.7: Transportation and packaging, page 84.
1.2.5 Battery replacement and disposal
CAUTION
Only Berlin Heart GmbH/ Berlin Heart, Inc. service staff or persons
authorized by the Berlin Heart GmbH service department may replace
the batteries and dispose of them in accordance with the respective
regulations.
1.3 Obligations of the operator
WARNING
Only qualified medical personnel trained specifically in the use of the
system are permitted to work with EXCOR. Training courses can be
arranged with Berlin Heart, Inc.
CAUTION
The operator (i.e. the hospital using the system) is responsible for
instruction and care of the patient. The patient must be instructed on
safety risks and cautionary measures (moisture, temperature,
electromagnetic fields, etc.).
The operator is also responsible for adherence to the prescribed
maintenance and service intervals (see section 2.8: Battery
replacement and disposal, page 23 and Tab. 2-1, page 23).
A replacement Ikus and replacement equipment must always be
available in the hospital.
If any of the components are damaged or if faults occur, inform Berlin
Heart GmbH/ Berlin Heart, Inc. service department immediately. Do not
use damaged components.
Only operate the Ikus with the components specified in this document.
Never operate the Ikus with multiple-socket mains adapters or mains
extension cables.
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