Alarm Schemes; Old Alarm Scheme - Fresenius Medical Care multiFiltrate Instructions For Use Manual

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Chapter 5: Alarm processing
5.2

Alarm schemes

5.2.1

Old alarm scheme

Basic assignment
5-2
Note
The alarm scheme selected must be evaluated to ensure it is suitable
for the place of operation and the environmental conditions, and it must
be specified by the responsible organisation.
The device features two alarm schemes. The chosen scheme is
configured in Service Mode.
Any switching between schemes must be authorised and performed by
– or on behalf of – the organisation responsible for the use of the device.
The alarm scheme defines the information, warnings, and alarms
provided to the operator if malfunctions occur, plus the alarm
conditions.
An alarm always involves a visual and an audible signal. The required
information or cause of the alarm is also displayed as text on the screen.
All visual signaling of alarms and their priority is displayed using the
operating status indicator. This displays the appropriate colour (red,
yellow, green) in a specific flashing pattern.
The audible signals generated by alarm conditions are related to the
visual display. They also use a range of tone sequences and patterns
of repetition to inform the operator about the priority and the relevance
of the alarm condition.
The "Old" alarm scheme displays a condition-oriented system of alarms
and corresponds to the former alarm schemes provided by the
Fresenius Medical Care range of devices.
The "New" alarm scheme displays the potential danger presented by an
alarm situation. It assigns a priority to every alarm and is based on the
alarm standard EN 60601-1-8 for medical devices used in intensive
medical care.
This alarm scheme defines an absolutely unambiguous relationship
between the alarm situation, device response, and alarm.
An alarm condition (blood alarm) stops the blood and balancing circuits:
The operating status indicator is red and the system emits an audible
signal.
An alarm condition (balance warning) stops the balance circuit:
The operating status indicator is yellow and the signal emits an audible
warning.
Internally, the alarms and warnings are given different priorities
(described in the following section).
The system also offers the option of using isolated audible signals to
inform the operator.
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015

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