Instructions for use: Ikus - Berlin Heart

4.6 Safety
4.6.1 Fall-back redundancy of pneumatic systems for univentricular mode
A pneumatic system supplies the blood pump. The two other systems act as
redundancies. If the active system fails, then the backup system supplies the pump.
From then on, a system is available as a redundancy.
4.6.2 Fall-back redundancy of pneumatic systems for biventricular mode
Two pneumatic systems each supply one blood pump. The third system acts as a
redundancy. If one of the active systems fails, then the third (backup) system supplies
the corresponding pump. The performance of the Ikus remains completely unaffected.
If two systems fail, then the remaining pneumatic system supplies both pumps. In this
case, the Ikus runs in emergency operating mode.
Emergency operating mode
If two pneumatic systems fail in biventricular mode, then the remaining system supplies
both blood pumps. The Ikus then operates in synchronous mode with 250 mmHg
systolic pressure, - 100 mmHg diastolic pressure, 70 beats per minute and a relative
systolic duration of 40%.
Redundancy of the pneumatic systems in biventricular mode
4.6.3 Control processor design with fall-back redundancy
The control processors also have a redundant design. The Ikus is equipped with two
independently functioning control processors. The main processor controls the
pneumatic systems and transfers functionally important data to the laptop. The backup
control processor constantly compares its calculation results with those of the main
processor. Any differences result in an error message. For safety reasons, the control
processors are housed inside the Ikus casing and work independently from the laptop.
Emergency pulse mode
The emergency pulse circuit board is the final safety system in the electronics. If both
computers fail, it assumes control. To largely eliminate error sources, the emergency
pulse circuit board functions autonomously and cannot be influenced by either the two
computers or the laptop.
In emergency pulse mode, the Ikus works with the following settings: Synchronous
mode (biventricular), systolic pressure 200 mmHg, diastolic pressure - 40 mmHg, rate
90 bpm, relative systolic duration 40%.
4.6.4 Battery mode
4.6.5 Manual pump
If the mains power supply fails, the batteries supply the system with power for at least
50 minutes. The battery operation indicator lights up. Every ten minutes, an acoustic
signal sounds. Every ten minutes, a new message in the monitoring program reports the
time already elapsed in battery mode. The LEDS in the grip area show the charge status
of the batteries.
The supplied manual pump (also BVAD) can be used temporarily to operate the blood
pump if a functional Ikus is no longer available; see page 81.
Safety
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