Muller Medical - France

FAQ, Frequently Asked Questions

You will find questions and answers to topics that interest you most frequently and which are related to the company Muller Medical, medical devices, the medical sector, the regulatory framework.
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Questions
Why Muller Medical?	Muller Medical is a company specialized in respiratory medicine. Its employees have a long experience in medical technology
Tube flowmeter or dial compact flowmeter?	Both technologies have their advantages. The dial flowmeter provide access quickly to a pre- defined flow rate and the flow meter is compact. The tube flowmeter has a more accurate adjustable flow with the visualization of the gas flow.
Disposable or re usable humidifier?	The disposable humidifier is used for a single patient. They are pre- filled with sterile water. Re usable humidifiers must be sterilized for every new patient and filled with sterile water. Re usable humidifiers represent in the long term a better economic compromise.
Autoclave/Sterilization at 121°C or 134°C?	This applies to humidifiers. Temperature indication is present on the jar. The limit is 121° C for polycarbonate and 134° C for glass and polysulfone, recommended temperature for better disinfection.
What is the CE mark?	This is the certificate of compliance with European Directive 93/42/EEC of the quality insurance system of medical devices. It is granted to a manufacturer of medical devices following the audit by a notified body (in France the LNE GMED). These devices can then be used for patients in all countries of the European Community .
What should I do in case of an incident with a device?	It is a case of Materio-vigilance. You must notify the direction of your hospital, and the National Health Department of your country as well as the manufacturer or its local representative

Questions

Why Muller Medical?

Muller Medical is a company specialized in respiratory medicine. Its employees have a long experience in medical technology

Tube flowmeter or dial compact flowmeter?

Both technologies have their advantages. The dial flowmeter provide access quickly to a pre- defined flow rate and the flow meter is compact. The tube flowmeter has a more accurate adjustable flow with the visualization of the gas flow.

Disposable or re usable humidifier?

The disposable humidifier is used for a single patient. They are pre- filled with sterile water. Re usable humidifiers must be sterilized for every new patient and filled with sterile water. Re usable humidifiers represent in the long term a better economic compromise.

Autoclave/Sterilization at 121°C or 134°C?

This applies to humidifiers. Temperature indication is present on the jar. The limit is 121° C for polycarbonate and 134° C for glass and polysulfone, recommended temperature for better disinfection.

What is the CE mark?

This is the certificate of compliance with European Directive 93/42/EEC of the quality insurance system of medical devices. It is granted to a manufacturer of medical devices following the audit by a notified body (in France the LNE GMED). These devices can then be used for patients in all countries of the European Community .

What should I do in case of an incident with a device?

It is a case of Materio-vigilance. You must notify the direction of your hospital, and the National Health Department of your country as well as the manufacturer or its local representative

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