Pregnabit Cloud is a SaaS (Software as a Service) software system designed to work with telemedical CTG devices implementing the required communication protocol to send measurement data during an examination. The software receives the data and analyzes it to facilitate its interpretation and to facilitate correct queuing for description by midwives and doctors. The system has a patient module that allows the patient to securely log into the system, enter pregnancy information and fill out a qualification form. The patient also has access to descriptions of her examinations after they are performed.
Pregnabit Cloud is medical software accessible via a web or mobile browser via desktop, laptop, tablet, smartphone and similar devices, connected to the Internet, for monitoring fetal well-being in the last trimester of pregnancy, based on records of CTG examinations performed by medical devices transmitting 4 sets of data to Pregnabit Cloud:
– Point set time[ms]/value[bpm] of maternal heart rate
– Point set time[ms]/value[bpm] of fetal heart rate
– Point set time[ms]/value[%] of uterine contractions
– Point set time[ms]/event of fetal movements
– Provides interfaces for professionals – doctors and midwives providing care to pregnant women. They can manage medical data, view examination results and compare these results. Professionals also have at their disposal the results of computer analysis of the CTG examination.
– has a special Description Center module, the role of which is to enable remote supervision of patients using telemedical CTG devices. Within this module, the results of automatic CTG computer analysis, which are part of the device, are used to notify professionals of phenomena detected during recording. The notifications make it possible to check whether the abnormalities registered in the CTG signal are related to the risk of pregnancy and to react adequately to the situation early enough. Due to the lack of a clear relationship between abnormalities in the CTG recording and health status, these notifications are not in the nature of an alarm, but only a notification. The results of computer analysis are applied to completed registrations – examinations – to determine the place in the queue for description. The queue ordering mechanism takes into account the time an examination spends in the queue.
– Provides the ability to take notes on patient contact and send records for consultation. Doctors working in the Description Center have the opportunity to evaluate the effects of the Center’s work through the Device.
The Pregnabit Cloud medical device was classified as a Class IIa device and underwent a certification process against the requirements of Directive 93/42/EEC. The Notified Body TÜV Nord Polska Sp. z o.o. participated in the conformity assessment process. The assessment ended with a positive result enabling the issuance of a CE Certificate with the number TNP/MDD/0292/4413/2019. The product was placed on the market in 2021 and is still on the market to this day. No medical incident has ever been reported for the Pregnabit Cloud medical device, nor has the device been the subject of a suspension and/or recall.
technical specifications of Pregnabit Cloud
information about mobile CTG Pregnabit Pro
Pregnabit Pro / Pregnaone CTG examination data flow
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