002001E-02-4

Organization name

Trium Analysis Online GmbH

SRN

DE-MF-000007016

Manufacturer status

Active

19 warnings recorded — scroll inside the panel to see all entries.

• CW999

  Warning 11: The online evaluation of CTG recordings is based exclusively on the 'FHR1' signal. Therefore, it is possible (especially in cases of twin monitoring) that the displayed evaluation may not properly reflect the actual status.
• CW999

  Warning 12: No further CTG components such as acceleration, deceleration or variability are taken into account when the evaluation is based thresholds.
• CW999

  Warning 13: If the title bar and/or the time are not being updated, then CTG data is also no longer being updated. Check whether the error can be corrected through a "refresh" of the page. If this does not solve the problem, contact your system administrator immediately.
• CW999

  Warning 14: During the time that you cannot establish a connection to the server, the patient must be monitored via the printout from the local CTG monitor.
• CW999

  Warning 15: If it is necessary to change the monitoring mode from US to FECG, the US transducer should be first disconnected and the same fetal sensor socket on the device should be used for the FECG transducer.
• CW999

  Contraindication 1: Using the software on inappropriately operated hardware
• CW999

  Contraindication 2: Using the software against the intended use
• CW999

  Contraindication 3: Using the software to substitute medical expertise
• CW999

  Contraindication 4: Using the software without ensuring that at every time when the patients are endangered, immediate help can be initiated
• CW999

  Warning 1: Please keep your password safe and be observant when logging into the system. Your password should not be disclosed to anyone else as it gives you access to patient data that is protected by data privacy laws. Do not - as many people often do - keep it somewhere that can be accessed by others. Shut down Trium CTG Online before you leave the room to ensure that others cannot access the data and possibly manipulate it in your absence. When using this system, you are responsible for data security. In a worst case scenario, unauthorized use may lead to a misinterpretation of Trium CTG Online data with life-threatening consequences.
• CW999

  Warning 2: Clicking on the signal history button will show of the entire recording history. Please note that the signal history cannot be updated in the open window: no new data will appear in the window from this point on!
• CW999

  Warning 3: Do not rely exclusively on audible alerts but check the alarm condition regularly by means of visual alarms. The volume of the alarm sound can be adjusted to a low level or even muted.
• CW999

  Warning 9: The display of the paper strip is configured globally in Trium CTG Online. If the fetal monitor has a different setting for paper speed (1, 2 or 3 cm/min) and paper layout (international or US), there may be a difference between the display of the electronic and paper strip.
• CW999

  Warning 4: Technical alerts may indicate a server problem that may require intervention by the administrator. Click on the technical alert symbol in the navigation bar to see the error. If the error state persists for more than 5 minutes, inform your system administrator.
• CW999

  Warning 5: If the time and/or the blue title bar does not update regularly, there is either a network or server error. In this case, check and/or re-establish the connection. If error cannot be corrected by reloading the page in your browser, please inform your system administrator and initiate a CTG paper strip check on-site.
• CW999

  Warning 6: Take care when assigning a fetal monitor or when connecting a patient to the fetal monitor. Wait until the fetal monitor is displayed as free in the monitoring window. Before you can reassign a fetal monitor, you must wait for approximately one minute, otherwise all newly recorded data is assigned to the previous patient. In the worst case scenario, this can lead to a life threatening misinterpretation of the situation of the patient and her unborn child.
• CW999

  Warning 7: Find out first-hand which fetal monitors have been assigned and to whom by going to the patient's location. It is your responsibility to know exactly who is connected to which device. In the worst case scenario, lacking this knowledge can lead to life- threatening mistakes.
• CW999

  Warning 8: The values calculated for short-term variability (STV according to Dawes / Redman) are for information only and are therefore not suitable for diagnosis. Despite implementation of this parameter according to the published information from Dawes and Redman, deviations from the implementation produced by Oxford Instruments are possible as different algorithms are used to calculate other important Trium CTG Online components such as baseline, acceleration and deceleration.
• CW999

  Warning 10: The online evaluation of CTG recordings is based exclusively on the 'FHR1' signal. Therefore, it is possible (especially in cases of twin monitoring) that the displayed FIGO evaluation may not properly reflect the actual status.

Primary placement in Germany; available across 11 countries total.

Trade name

not provided

UDI-DI code

04260346620010

Basic UDI-DI

426034662TriumCTGOnlineQU

Reference / catalog number

002001E-02-4

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://viewpoint-sw.gehealthcare.com/login

Clinical sizes

No clinical sizes registered for this device.

• Z12080192PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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