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510(k) Data Aggregation
K Number
K103172Device Name
CIV-OB (PLUS)
Manufacturer
CIVNET COMMUNICATION LTD
Date Cleared
2011-03-11
(134 days)
Product Code
HGM
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
CIVNET COMMUNICATION LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CIVNET CIV-ob™ (plus) is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting
The CIVNET CIV-ob™ (plus) is indented to manage perinatal monitoring data acquired from bedside monitors or manual inputs for viewing at the central nursing station. The system also produces an electronic medical record.
The CIVNET CIV-obTM (plus) has display fields for the following obstetric data:
- Monitoring site details
- Patient demographics
- Provider notes
- FHR
- Uterine Activity (via tocodynamometry IUP)
- Head Decent
- Cervix Dilation
Device Description
The CIVNET CIV-ob™ (plus) Obstetrical Data Management and Monitoring software application is for remote display, archiving and data management of fetal/maternal bedside monitor and/or Birth Tracking monitors. The CIVNET CIV-obTM (plus) is intended for use as a clinical data management and monitoring system for multiple bedsides with the added ability to connect multiple monitors to a single bed side. The CIVNET CIV-ob™ (plus) is indicated for maternal/fetal vital signs data management and is suitable for the hospital and clinical environment.
The CIVNET CIV-ob™ (plus) Data Management and Monitoring software application is intended for automatic fetal/maternal monitoring and patient data management. The application does this by:
- a) Providing Obstetrical Data Management and remote display of information and graphs from Obstetrical monitors.
- b) Displaying real time fetal heart rate and TOCO data HS and CD data received from the patient bed-side in a one-to-one representation as it is displayed on the fetal/maternal monitor.
- c) Providing the means to display multiple beds simultaneously.
- d) Providing automatic Archiving of the data.
- e) Providing Administrative Control to ensure that the system performs without technical failure.
- Providing easy interfacing with any IT patient record system for data acquisition, viewing and storage of electronic patient record.
- g) Providing visual notification of fetal/maternal monitor alerts such as out of limit heart rate or poor signal quality.
- h) Providing the ability to record as part of the patient record, fluid input and output information that is defined by the user.
- i) Providing the user the ability to enter comments and specific data.
- j) Providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk).
- k) Providing the ability to print (locally or remotely) patient records and CIV-obTM (plus) data base definition (e.g. item names).
- l) Providing the ability to connect multiple monitors to a single bed side.
The role of the CIV-ob™ (plus) software remains the same as the CIV-ob™ in that the CIV-ob™ (plus) system is designed to archive electronic data provided by the fetal/maternal monitor, and to display real-time graphical data received from the monitor via the hospital network.
The CIV-OBTM (plus) system is comprised of five modules:
- 1. Main Server (with an option of multiple servers per site)
- 2. Mid Server for every Birth Tracking monitor
- 3. Monitoring Station
- 4. Central monitor module
- 5. Site Sniffer control and revision module
The CIVNET CIV-ob™ (plus) is a modification of the CIVNET CIV-ob™. It contains the same functions, with the following additions:
- . The development environment tool used is Microsoft ".Net" developing environment.
- Display of Cervix dilation birth tracking parameter
- Display Fetal head decent birth tracking parameter
- Display of all birth tracking alert messages present on the birth tracking monitor . is part of the remote monitoring.
CIVNET CIV-OB™ (plus) is intended to be marketed in three configurations.
- Configuration 1 CIV-OB™ (plus) for Data Management and Monitoring of . both obstetrics and birth tracking
- Configuration 2 CIV-OB™ (plus) for Data Management and Monitoring of ● obstetrics only
- Configuration 3 CIV-OB™ (plus) for Data Management and Monitoring of fetal . birth tacking only
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