many

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.

• 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.

• Prudence, risque de choc électrique

  • There is a risk of electric shock if the Rest stand of the device is damaged or can not be fixed to the product. Do not use the product and immediately ask the manufacturer and the seller for repair. • 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.

• Consulter la notice d’utilisation

  •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. Spirometry is a safe and valuable test for assessing lung function. However, there are certain situations where it is not advisable to perform spirometry due to potential risks or interference with test results. •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.

• Dangers liés aux champs magnétiques

  • Warning: MR-unsafe! 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. • MAGNETIC AND ELECTRICAL INTERFERENCE: X-ray device or MRI devices are possible sources of interference as they may emit higher levels of electromagnetic radiation.

• Avertissement

  •Do not use the device together with other electronic devices •DISPOSAL - At the end of its service life, the product described in this manual, as well as its components, must be disposed of in compliance with local, state, or federal guidelines regulating the disposal of such products. If you have questions concerning the disposal of the product, please contact Bionet or its distributor. POWER REQUIREMENTS - Before connecting the device to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the label of the device. If this is not the case, do not connect the system to the power line until you adjust the device to match the power source. Device connected to the ECG system and to the patient’s environment must be powered from a medically isolated power source or must be medically isolated device. Device powered from a non-isolated source can result in chassis leakage currents exceeding safe levels. Chassis leakage current generated by the components or device connected to a non-isolated outlet may be added to the chassis leakage current of the ECG system.

• Modifications to Cardio P1 are not allowed. Any unauthorized changes to the Cardio P1 device may compromise product safety and/or data. As a result, Cardio P1 cannot be held responsible, and the device will no longer be supported.

  AUTRE

• Contraindications: There are no absolute contraindications to performing an electrocardiogram (ECG) using the Cardio P1 device, except for explicit patient refusal. However, certain conditions may require special precautions to ensure signal quality and patient comfort. These are not strict contraindications, but should be considered during device use: • Known hypersensitivity to adhesives used in ECG electrodes • Local skin issues at electrode placement sites (e.g., open wounds, burns, severe dermatitis) • Presence of implanted cardiac devices (e.g., pacemakers), which may complicate ECG interpretation In such cases, the use of hypoallergenic electrodes, alternative lead placement, and supervision by clinicians trained in ECG acquisition is recommended to ensure accurate and safe data collection. The Cardio P1 should not be used in situations where proper electrode placement or reliable signal acquisition cannot be ensured.

  AUTRE

• • The Cardio P1 must always operate within its specified accuracy limits. •Maintenance must not be performed while the device is in use by a subject. •The Cardio P1 should not be used in the presence of flammable liquids or gases, dust, sand, or any other chemical substances. • Use of Cario P1 adjacent to or stacked with other devices should be avoided, as it may cause improper operation. If such use is unavoidable, both Cardio P1 and the other devices must be observed to ensure that they function correctly.

  AUTRE

Marché principal en Allemagne ; disponible dans 13 pays au total.

Dénomination commerciale

non renseigné

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.

08809276943972

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.

880927694CP1SW

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 human-readable 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

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

Santé des certificats sur le portefeuille de ce fabricant.