running machine - H-P-COSMOS Sports and Medical
running machine - H-P-COSMOS Sports and Medical
running machine - H-P-COSMOS Sports and Medical
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[4.F] <strong>Medical</strong> device software<br />
safety, warnings, precautions, prohibitions<br />
Software safety classification according to EN 62304 medical device software; software lifecycle processes:<br />
The manufacturer has to assign a software safety class to any software, according to consequences caused by the software<br />
in form of a danger on the patient, the applier or third parties.<br />
The software safety classes, based on the severity, are assigned as follows:<br />
Class A: No injury or damage to health possible<br />
Class B: No SERIOS INJURY possible<br />
Class C: DEATH or SERIOS INJURY possible<br />
Without risk reducing measurements <strong>and</strong> risk reducing design a software for treadmills <strong>and</strong> interface protocols would have to<br />
be classified as Class C most dangerous with death result, because for example undesired <strong>and</strong> uncontrolled acceleration of<br />
the <strong>running</strong> belt can always cause falling off with the possible result of a broken neck. Due to a possible technical<br />
malfunction of a measurement (e.g. heart rate measurement), which has to be theoretically be taken into account, the patient<br />
may be overloaded with the possible result of death.<br />
Also on the part of the dem<strong>and</strong> on SOUP (software of unknown provenance) it has to be stated, that medical treadmill<br />
ergometers <strong>and</strong> their software use SOUP components. So the frequency inverter, motor regulation, firmware <strong>and</strong> parts of the<br />
pc software are components of medical treadmill ergometers <strong>and</strong> the treadmill manufacturer has no access to design,<br />
validation <strong>and</strong> maintenance of these components of suppliers. For this reason always the worst case of a malfunction has to<br />
be taken into account.<br />
h/p/cosmos classifies the internal firmware <strong>and</strong> software components as Class B due to a number of risk reducing design<br />
features <strong>and</strong> measurments.<br />
Healthy people in sports are usually able to activate the emergency stop button of the treadmill <strong>and</strong> this way to switch off the<br />
treadmill quickly in case of emergency caused by a malfunction. Thus, the emergency switch off has to work completely<br />
without software <strong>and</strong> has to brake the power supply of the treadmill. For patients <strong>and</strong> medical users fast reactions of the<br />
patient <strong>and</strong> therewith a fast switch off of the treadmill are not guaranteed because for a patient also very light acceleration<br />
may cause in falling off. To control the risk for patients <strong>and</strong> persons with any disabilities a fall prevention system (e.g. safety<br />
arch with chest belt, harness <strong>and</strong> fall stop rope) which prevents falling off (catches the patient) has to be used for<br />
applications with a higher risk of falling (e.g. patients after hip replacement, neurologic patients, cardiac patients, maximum<br />
load tests, etc.) or in cases falling could result in serious injuries, for example if the patient is connected to invasive probes.<br />
For the acceleration of the drive motor <strong>and</strong> <strong>running</strong> belt safety delay design measures have been incorporated, which<br />
prevent from extreme fast acceleration in case of any malfunction.<br />
Warning labels based on EN 957-6 about possible malfunction <strong>and</strong> inaccuracy of heart rate sensors are placed on the<br />
treadmill <strong>and</strong> in the operation manual.<br />
Furthermore the patient on the medical treadmill has to be observed permanently <strong>and</strong> the medical staff has to be within 1.5m<br />
around the patient.<br />
The risk analysis <strong>and</strong> risk control are included in the risk management according to EN 14971.<br />
file: n:\article\cos14310m5-v1_06hpc-en\20120215_cos14310m5-v1.06hpc-en_manual_h-p-cosmos_<strong>running</strong>_<strong>machine</strong>.doc<br />
© 2012 h/p/cosmos sports & medical gmbh email@h-p-cosmos.com created 15.02.2012 printed 15.02.2012 page: 25 of 213