CardioExpress 4012

Organization name

Bionet Co., Ltd.

SRN

KR-MF-000013439

Manufacturer status

Active

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

• CW010

  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.
• CW011

  •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.
• CW999

  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.
• CW273

  • 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.
• CW259

  • 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.
• CW023

  • 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 M R 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.
• CW999

  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.
• CW017

  Class I protection against electric shock and Type CF defibrillation-proof.
• CW999

  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.

Primary placement in Spain; available across 8 countries total.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12050301GENERAL PURPOSE ELECTROCARDIOGRAPHS

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.