NOMIX

Organization name

MESURONS

SRN

FR-MF-000043601

Manufacturer status

Active

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

• CW083

  The device shall be applied on a healthy skin, without wound, that usually does not react to interactions with biocompatible materials.
• 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.
• CW020

  The device is not sterile and is not intended for sterile application
• CW022

  Do not disassemble the device (open the cover, etc.).
• 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.
• 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.
• CW023

  Do not use the device near electromagnetic sources.
• 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.)
• 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.
• 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.

Primary placement in France; available across 1 country total.

Trade name

not provided

UDI-DI code

03770036057008

Basic UDI-DI

3770036057NOMIX4R

Reference / catalog number

NOMIX

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Mobile 12-lead resting ECG recorder

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12050301GENERAL PURPOSE ELECTROCARDIOGRAPHS

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

Certificate health across this manufacturer's portfolio.