Berlin Heart EXCOR Adult, Instructions For Clinical Use

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General Information EXCOR Active
en
Impermissible combinations
Combination with the following diagnostic procedure is not allowed:
• magnetic resonance imaging
Permitted
Combination with the following diagnosis/therapy procedures is permitted:
• high-frequency surgery, diathermy (flow measurement may be disrupted for the
duration of the high-frequency surgical procedure).
• radiotherapy
• nuclear diagnostics / nuclear therapy
• CT scans
• electrostimulation therapy
• therapeutic ultrasound (e.g. lithotripsy)
Other combinations
No other devices may be connected to the EXCOR Active system; otherwise, the elec-
trical safety of the patient cannot be guaranteed.
Combinations with other products or procedures not expressly approved here is at the
discretion of the treating physician.
3.7 Replacement Components
Suitable types, quantities and sizes of the following components must be available at
the hospital for replacement purposes:
• for LVAD and RVAD patients: driving unit (EXCOR Active or Ikus)
• for BVAD patients: EXCOR Active, configured with patient’s current settings
• flow sensor including cable wrap
• red-marked and/or blue-marked driving tube
• blood pump
• T00L-002
• connector set, cannula extension set, if required for therapy
3.8 Information Regarding the Instructions for Use
The instructions for use are a part of the EXCOR system. Please keep the instructions
for use in a safe place. In the event of loss or damage, another copy of the instructions
for use can be requested from the manufacturer. You can download the instructions
for use from the manufacturer’s website. See chapter 1: Contact, page 13.
3.9 Disposal of Components
General
Electronic components may be returned to the Manufacturer for professional disposal.
Professional disposal of all other components is the responsibility of the operator.
Batteries
Defective batteries may not be returned to the manufacturer. Old or defective batteries
must be disposed of in accordance with local regulations.