Nom de l'organisation

Bionet Co., Ltd.

SRN

KR-MF-000013439

Statut du fabricant

Actif

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

• Dangers liés aux champs magnétiques

  Consider hazards from magnetic fields • DO NOT expose the device to a magnetic resonance (MR) environment. • The device may present a risk of projectile injury due to the presence of ferromagnetic materials that can be attracted by the MR magnet core. • Thermal injury and burns may occur due to the metal components of the device that can heat during MR scanning. • The device may generate artifacts in the MR image. •The device may not function properly due to the strong magnetic and radiofrequency fields generated by the MR scanner. •Use of components, transducers and cables other than those specified or provided by the manufacturer of this device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation. •To reduce the risk of electric shock, do not remove cover or back. Refer servicing to qualified personnel.

• Prudence, risque de choc électrique

  • There is a risk of electric shock if the Rest stand of the device is damaged or not be fixed to the device body. • Do not use the product and immediately ask the manufacturer or seller for repairs. • ACCIDENTAL SPILLS - If the device is penetrated with liquid, take it out of service and have it checked by a service technician before using it again. •DO NOT allow liquids to enter the device to prevent electric shock or device malfunction. •Improper use of this device may cause electric shock. •To reduce the risk of electric shock, do not remove the cover or back of the device. Refer servicing to qualified personnel. •It is very rare but there is a possibility of electric shock caused by leakage current.

• Partie appliquée de type CF protégée contre les chocs de défibrillation

  • ClassⅠprotection against electric shock and Type CF defibrillation-proof.

• Avertissement; Électricité

  • There is a risk of electric shock if the Rest stand of the device is damaged or not be fixed to the device body. • Do not use the product and immediately ask the manufacturer or seller for repairs. • ACCIDENTAL SPILLS - If the device is penetrated with liquid, take it out of service and have it checked by a service technician before using it again

• Avertissement

  •Biocompatibility according to international standards. •Do not use the device together with other electronic devices. •When the patient who had an operation to have a heart assist device uses the Cardio Q50, it should be done under the supervision of a health care professional who has undergone Cardiac Assist Device surgery. •A mouthpiece(disposable) is for single use only. They should not be reused as performance may degrade or contamination could occur. •Failure to follow this message may cause in non-life-threatening injury or damage to the Device. •Improper connection will cause inaccuracies in the ECG. Trace each individual lead-wire from its acquisition module label to the colored connector and then to the proper electrode to ensure that it is matched to the correct label location. •BATTERY POWER - If a device equipped with an optional battery pack will not be used or connected to the power line for a period of over six months, remove the battery. •Compatibility is critical to safe and effective use of this device. Please contact your local sales or service representative prior to installation to verify device compatibility. •At the end of its service life, the product described, as well as its components, must be disposed of in compliance with local, state, or federal guidelines regulating the disposal of such products. •Portable RF communications device (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) cables specified by the manufacturer. •SERVICEABLE PARTS - This device contains no user serviceable parts. Refer servicing to qualified service personnel.

• •Battery retention loss is greater at higher temperatures. As the battery ages, it may not be fully charged, as a result, the total charge capacity used for saving and using gradually decreases. •Conditioning Guidelines Check battery performance by fully charging and completely discharging it every 6 months. •AC Power When the device is connected to AC power, the Power LED on the front lights green. When a battery is mounted, it is charged in automatic charging mode. [Warning] Be sure to connect this device to a power supply with protective grounding. • The EMISSIONS characteristics of this device make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this device might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the device.

  AUTRE

• Modifications to this device are strictly prohibited as they may compromise safety and data integrity. Do not use in the presence of flammable liquids, gases, or chemicals. Ensure subjects do not block the mouthpiece during tests to prevent false readings.

  AUTRE

• This device is a diagnostic tool for spirometry. Accuracy must be validated daily with a 3-L syringe and checked after cleaning, disassembly, or accidental drops. The device is non-sterile; follow manufacturer instructions for chemical cleaning.

  AUTRE

• Consulter la notice d’utilisation

  Contraindication: Skin Conditions: If a patient has extensive skin lesions, burns, or other skin conditions in the areas where electrodes are placed, it might be challenging to obtain a clear ECG signal. In such cases, alternative electrode placement or other cardiac monitoring methods might be considered. Allergic Reactions: Some individuals may experience allergic reactions to the adhesives or gels used to attach the electrodes. If a patient has a history of allergies, hypoallergenic alternatives should be used. Implanted Electronic Devices: Patients with implanted electronic devices, such as pacemakers or defibrillators, might require special precautions during ECG procedures to avoid interference with the device's function. Agitation or Anxiety: If a patient is extremely agitated or anxious, it might be difficult to obtain a clear ECG recording due to movement artifacts. In such cases, calming measures or alternative monitoring methods might be considered. Coughing up blood (hemoptysis) of unknown origin: The forceful exhalation involved in spirometry could worsen the underlying condition causing hemoptysis. Collapsed lung (pneumothorax): Spirometry could exacerbate a pneumothorax or increase the risk of recurrence. Unstable cardiovascular conditions: Spirometry could worsen angina or cause blood pressure fluctuations. This includes recent heart attacks (myocardial infarction), pulmonary embolisms, or the presence of aneurysms in the chest, abdomen, or brain. Recent eye surgery: Spirometry could strain the eye and affect healing, particularly after cataract surgery. Acute illnesses: Conditions like nausea or vomiting could interfere with the ability to perform spirometry effectively. Recent surgery in the chest or abdomen: Spirometry could strain healing tissues and affect recovery.

Marché principal en France ; disponible dans 32 pays au total.

Dénomination commerciale

CardioExpress 5012

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.

08809276944276

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.

880927694CQ57NE

Numéro de référence/catalogue

many

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 RDM

Les classes de risque du RDM 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 IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

(10) is categorized as a Lot number but actually represents version information (Format: V+version number). Parentheses in the human­readable entries are for identification only; for DataMatrix barcode recognition, they must be represented without parentheses. Labels are affixed to the product box and are not separately attached to the storage device.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

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.

• Z12050301GENERAL PURPOSE ELECTROCARDIOGRAPHS

• Dispositifs médicaux de Classe IIa dans EUDAMED

Santé des certificats sur le portefeuille de ce fabricant.