SCHULTE-ELEKTRONIK

SISS Respiration Rate Monitors

SISS Baby Control Important Safety Infomation for Safe Use Dec 2018

Important Safety Infomation

3 Pages

Important safety information Supplementary information of the manufacturer for the safe use of the following devices: SISS BABYCONTROL SISS BABYCONTROL plus SISS BABYCONTROL BCE SISS BABYCONTROL BCS SISS BABYCONTROL DE SISS BABYCONTROL DS SISS BABYCONTROL H SISS BABYCONTROL M  Respiration monitors Respiration and heart rate monitors Respiration and heart rate monitors Respiration, heart rate and SpO2 monitors Respiration and heart rate monitors Respiration, heart rate and SpO2 monitors Respiration and heart rate monitors Respiration, heart rate and SpO2 monitors  SCHULTE-ELEKTRONIK reference : BC_2018_12_14  date: 14.12.2018  Dear user, operator or distributor of the medical devices mentioned above, this document contains important information that will enable you to continue the proper and safe use of the above listed devices. Taking into account feedback from users of the SISS BABYCONTROL respiration monitor, we see the necessity to provide you with the following supplemental safety information on the use of said devices in the monitoring of respiration. Description of the problem: In certain application situations, due to the sensitivity of the respiratory sensor, it is also possible that signals are triggered which in fact do not originate from the respiratory movement of the patient. The monitor processes the sensor signals. In doing so, the signals that do not belong to the respiratory movement can be misinterpreted, with the result that a possible alarm for a lack of respiratory movement is not released, erroneously. It has been reported by some users that, for example, the patient's own heartbeat or vibration in the immediate environment of the patient were interpreted as a breathing movement, mistakenly. As part of our investigation of these reports, we discovered that the affected devices have been used in a clinical environment and under special circumstances, which are not covered by the intended purpose of our devices. Our devices are designed as babymonitors helping to prevent possible endangered babies and infants for Sudden Infant Death Syndrome or for babies and infants which are suspicious after a polysomnographic examination as well as according to a physicians diagnose.  Within said intended purpose, the devices can be used both in the home environment, as well as in the hospital sector. However, the monitoring of intensive care patients is not covered by the intended purpose of our devices. Therefore, we would like to provide you with additional safety information and warnings (hereinafter and in the appendix) which are not yet included in the instructions for use in so many words.  2018-12-14 FSN BC_2018_12_14 EN.doc  page 1 of 3
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