Overview

Features & Benefits

Demonstration

FEATURES AND BENEFITS

• Provides real time accurate, reliable collection and display (surveillance) of fetal data at any PC location with internet access using a standard browser.
   
• The system is user friendly and multilingual (German, English, Italian, French, Portuguese, etc.) requiring minimal ‘housekeeping’ to ensure all CTG’s undertaken are viewed and stored accurately.
   
• Integrates with available hospital or OB/GYN information systems
   
• Supports all kinds of CTG models including Neoventa STAN®
   
• Support for additional measurement equipment (e.g. Nonin FetalSAT, Masimo FSpO2, ST-Analysis)
   
• Provides the ability to view simultaneously up to 24 beds per Server.
   
• The visual appearance of the displayed CTG maintains the aspect ratio of the conventional chart recording.
   
• Individual CTG records can be annotated using free text.
   
• All monitoring data acquired by the system is automatically stored with back up (option) and can be accessed at any time.
   
• Print reports/CTG traces using a standard PC printer.
   
• The system includes sophisticated CTG interpretation and analysis based on the FIGO recommendations. This provides real time support for users providing visual alarms when baseline, variability, accelerations, decelerations and signal loss deviate from normality as defined by FIGO.
   
• Calculation of the short term variability analogue to the Oxford CTG Dawes/Redman analysis
   
• Viewing of the CTG data does not require any specialist software. Any desktop or note book PC with inter- or intranet access to the Server and a browser can view the CTG data in real time.
   
• Access to the server is controlled by user name and password log in requirements. Data connections are secured by SSL.

DATA MODEL

• Each mother will be registered on Trium CTG Online (“the System”). Once a mother is registered on the System, she remains known to the System permanently.
   
• Each pregnancy may contain one or more monitoring episodes. Monitoring episodes are distinct by disconnection of devices for a configurable time.
   
• The system allows you to assign the responsible doctor or midwife to every current monitoring episode

CHALK BOARD

• The System has a “chalk board” display, capable of displaying patient details. The minimum dataset is mother’s name, age and gestation (para, gravida). Display of additional data is optional.
   
• It is possible to admit, remove or transfer between delivery rooms a patient by using the chalk board.
   
• If the patient is connected to a fetal monitor before her details have been registered, data collection takes place. The registration can be completed up to 4 weeks of the monitoring session.

ACQUISITION

• The System provides continuous (real time) acquisition and display of maternal and fetal signals acquired by the fetal monitors. Integration of additional signals such as SpO2 is optional.
   
• The System is capable of simultaneously collecting, in real time, maternal and fetal data from up to 24 fetal monitors.
   
• The System is compatible with, and works to full functionality with, Fetal Monitors made by the leading manufacturers (Corometrics, Philips, Oxford Sonicaid, Analogic, Neoventa).
   
• Data acquisition starts automatically when the PC detects the presence of an active fetal monitor. This does not require that a User be logged into the System at that time.
   
• The System provides a high level of security against data loss in the event of failures, using redundant hardware components.
   
• In the event of a power failure, data collected to that point is not lost. The System automatically restarts data collection once the power has been restored.
   
• In the event of a network failure, data collected to that point is not lost.
   
• Existing standard hospital networks can be used. There is no need for additional cables.

DISPLAY

• The System is capable of displaying, in real time, maternal and fetal data from up to 12 fetal monitors per screen.
   
• Figure 1: Overview display for 6 simultaneous monitoring sessions

  

  
   
• The real time display of CTG and associated traces will be on the client PC screens.
   
• The real time display has a familiar and clear format. It is similar to the format currently used by standard fetal monitors. Examples are available on request. (paper speed 1, 2, 3 cm/min)
   
• The PC display is easy to read and easy to understand, such that training needs are minimal. The demand for computer related skills by Midwifery and medical staff is low.
   
• Each PC is capable of displaying data from a single labour room or multiple labour rooms.
   
• If the System is monitoring a twin pregnancy using a single fetal monitor, the heart rate traces appear together on a single CTG display. The traces are recorded by the System within a single monitoring episode. The user can separate the heart rate traces using the CTG device or the user interface.
   
• There are facilities to scroll back through any CTG trace.
   
• There is the facility to view stored CTG traces remotely, both:
  • within the hospital, via the internal network, on any computer connected to the network with a standard browser version 5 or higher.
  • outside the hospital
  
   
• A monitoring episode is initiated by the System either by explicit User action, or else when the system detects the presence of an active fetal monitor. The monitoring episode is terminated by the System either by explicit User action or else when the System detects the absence of an active fetal monitor for a time configurable by an administrator. Note that this time interval corresponds to the value ‘N’ in the data model.
   
• The System has the ability to analyse FHR pattern in real time, according to the FIGO guidelines, for individual patients.

ALARMS

• If an alarm condition exists, it will be visible using a three stage pattern, using symbols changing from green, to yellow to red.
   
• Figure 2: Single session view with analysis and alarm details

  

  
   
• Global default alarm parameters follow FIGO standards.
   
• The global alarm is generated by the individual alarms for
  • Baseline fetal heart rate (limits according to FIGO)
  • Number of accelerations (according to FIGO).
  • Number and severity of decelerations
  • Variability of the signal
  • Signal loss for an unacceptable duration.
  
   
• Once activated, an alarm cannot be disabled while the alarm condition persists. If the alarm condition ceases, the System continues to indicate another 30 minutes the fact that an alarm condition had existed, until a user acknowledges it. This happens regardless of muting.
   
• The system calculates additional CTG interpretation values including short term variability according to Dawes and Redman. .

ANNOTATION

• The System permits pro- and retrospective annotations of the CTG with free-text. The System records the date and time at which the annotation was made; the identity of the annotator.
   
• The System supports storage and reuse of annotations (templates) and direct user context change.
   
• It is not be possible to change or delete an annotation retrospectively.
   
• The system is capable of displaying a list of annotations and alarms for a selected patient, sorted in chronological order within the CTG record, rather than sorted by time of entry.

STORAGE

• The storage System is capable of saving all records on-line.
   
• It is easy and quick to search for patient data. It is possible to search on any combination of patient name, hospital number or date of birth.

REPORTING

• It is possible to print to existing networked printers or to printers connected directly to the Server or to PCs.
   
• The database used for storage is a SQL database which is ODBC compliant.
   
• The selection of records for hard copy or export works on the basis of:
  • Patient identity (name, hospital number, date of birth)
  • Annotations (are planned)

SECURITY & QUALITY ASSURANCE

• Any interaction with the System is unambiguously identified with a specific User.
   
• It is possible to notify the System of a change of user without a break in the acquisition of the CTG.
   
• The security features of the System are simple to use.
   
• The System has a timeout, so that if acquisition stops for a period configurable by an administrator the System will require re-validation of the User.
   
• Quality control review is performed according to Trium's SOPs, legal regulations and international standards. Our clients are allowed to inspect the SOP's at our offices.
   
• The System is a CE marked medical product class IIb.