Trium CTG Online

Nom de l'organisation

Trium Analysis Online GmbH

SRN

DE-MF-000007016

Statut du fabricant

Actif

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• 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.

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

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• Warning 13: If the title bar and/or the time are not being updated, then CTG data is also no longer being updated.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.

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• 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.

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• 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.

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• Contraindication 1: Using the software on inappropriately operated hardware

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• Contraindication 2: Using the software against the intended use

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• Contraindication 3: Using the software to substitute medical expertise

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

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• 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.

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• 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!

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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Marché principal en Allemagne ; disponible dans 11 pays au total.

Dénomination commerciale

Trium CTG Online

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

04260346620010

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

426034662TriumCTGOnlineQU

Numéro de référence/catalogue

002001E-02-4

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

GS1

Catégorie de risque

Classes de risque MDR

Les classes de risque du MDR classent les dispositifs médicaux du risque le plus faible (classe I) au plus élevé (classe III), ce qui détermine le niveau de contrôle réglementaire.

Classe IIb

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

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

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Z12080192PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Dispositifs médicaux de Classe IIb dans EUDAMED

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.