Breathalyzer

Dénomination commerciale

Breathalyzer

06975247310035

697524731002KG

Numéro de référence/catalogue

3050105

GS1

Classe I

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The breathalyser is intended for the rapid determination of the alcohol concentration in the exhaled air of patients with clinical suspicion of alcohol intoxication or alcohol addiction. The breathalyzer is intended use in Professional healthcare facility environment.

URL des informations complémentaires

https://www.justec.cn/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• V0399MEASUREMENT DEVICES - OTHER

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

• CW011

  Disposable Mouthpiece are not designed to be reused. Reuse may cause a risk of contamination. Dry the device immediately in case of rain or water spray. Store and use the device in specified environmental condition. The device may not meet the performance specification due to aging, stored or used outside the specified temperature and humidity range. Contact the JUSTEC authorized service personnel for replacements if you find the equipment is damaged. NOTE: During normal use, the operator is expected to face the front of the equipment. Keep this manual in the vicinity of the equipment so that it can be conveniently referenced when needed. At the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance with the local guidelines regulating the disposal of such products.
• CW999

  Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the [ME EQUIPMENT or ME SYSTEM],including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Do not open the device housings. All servicing or future upgrades must be carried out by JUSTEC trained and authorized personnel. Do not modify this equipment without authorization of the manufacturer. Do not use the mouthpieces that not made by JUSTEC.