NOMIX Cables

Dénomination commerciale

non renseigné

Code d'IUD-ID

03770036057015

IUD-ID de base

3770036057NOMIXCABLESD5

Numéro de référence/catalogue

NOMIX Cables

Entité d'attribution

GS1

Catégorie de risque

Classe I

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Set de câbles pour NOMIX, type PCBC

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• Z12050380ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES

12 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW011

  Do not use the device while the battery is charging. Do not use the appliance near flammable gases. The device should be applied to the patient's skin and not directly to the heart.
• CW083

  The device shall be applied on a healthy skin, without wound, that usually does not react to interactions with biocompatible materials.
• CW017

  The device is CF rated against defibrillation only when used with its original NOMIX accessory cables. During defibrillation, do not touch the device, the patient or any conductive element near the patient (stretcher frame, etc.)
• CW999

  The user should inspect the device for damage before using it. The user must use the complete device (including its original cables). The user must only use original spare parts and accessories or those approved by the manufacturer. The use of disposable electrodes is recommended. They are for single use only. In case of difficulty in use (cables difficult to insert into their hole, etc.), the user must refer to the user manual to ensure that he is not in error. The available filters constitute a distortion of the original signal. The device is a rest electrocardiograph. It must not be used as a monitoring electrocardiograph or as an exercise electrocardiograph. An electrocardiogram cannot replace a complete cardiology consultation, taking into account in particular the patient's clinical condition, history, symptoms, results of other medical devices, etc. Automatic measurements and analysis are useful when used appropriately. They can be distorted for various reasons such as artifacts, extrasystoles… and generally speaking no automated tool is 100% effective. Thus, it is imperative that a qualified healthcare professional reviews these suggestions in order to confirm or modify them before any decision regarding the patient's management.
• CW022

  Do not disassemble
• CW010

  The device should only be used after reading and understanding this user manual. If in doubt about its understanding, contact your local dealer or distributor.
• CW020

  The device is not sterile and is not intended for sterile application
• CW113

  Do not heat or wet the device. If the device is hot, stop using it until it has cooled down to the correct temperature.
• CW023

  Do not use the device near electromagnetic sources.
• CW142

  It is not intended for use in the operating room in the presence of flammable anesthetic gases or electrosurgery, nor outdoors.
• CW135

  Caution: risk of strangulation with the cables
• CW036

  IEC 60601-1 requires that any other device connected to this device must be Type I. The user must ensure that the sum of the leakage currents does not exceed the limit so as not to injure the patient.

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