China News Service, January 8th. According to the news from the WeChat public account of "Shanghai Market Supervision" on the 8th, recently, the rush to buy oxygen generators has attracted social attention.

Who is suitable for this medical device that can provide oxygen at home and reduce "silent hypoxia"?

What problems should be paid attention to when purchasing?

What is an oxygen concentrator?

　　According to the official website of the State Drug Administration, the oxygen generator is also called a small molecular sieve oxygen generator, a medical molecular sieve oxygen generator, a portable oxygen generator, etc. Its basic working principle is through the principle of pressure swing adsorption (PSA), using air as the raw material , does not require any additives, after the power is turned on, it absorbs nitrogen and other gases in the air, and separates oxygen with high purity (93%±3%) from the air.

　　An oxygen generator generally consists of an oxygen generator, a flow meter, a humidifier, and an oxygen concentration status indicator. The oxygen concentration status indicator can send out an alarm when the oxygen concentration is lower than 82%, so as to prevent the user from inhaling oxygen that does not meet the oxygen concentration requirements. gas.

Is the oxygen generator a medical device?

　　As we all know, my country implements classified management of medical devices according to the degree of risk.

　　According to the "Chinese Medical Device Product Classification Catalog", oxygen generators are currently classified as Class II medical devices in my country, and they can only be sold on the market after the "Medical Device Registration Certificate" issued by the national drug administration department.

Its manufacturers need to obtain the "Medical Device Production License" issued by the drug regulatory department, and the sales unit should have the "Class II Medical Device Operation Record Certificate".

　　Therefore, no matter the name is "medical oxygen concentrator", "household oxygen concentrator", "small oxygen concentrator" or "molecular sieve oxygen concentrator", it is essentially a "medical oxygen concentrator", and it should have a medical device registration certificate.

Who are the oxygen concentrators suitable for?

　　In general, oxygen concentrators are suitable for patients with cardiovascular and cerebrovascular diseases and respiratory diseases who have already experienced hypoxemia, and patients with chronic obstructive pulmonary disease are more representative.

In addition, patients with other diseases who have hypoxemia, high altitude pulmonary edema, acute mountain sickness, high altitude coma, etc. due to low oxygen in the environment also need oxygen therapy as soon as possible.

　　For ordinary consumers, experts pointed out that oxygen concentrators are mainly used by patients with chronic respiratory diseases, and general healthy families do not need to configure oxygen concentrators at home.

If chest tightness, wheezing, dyspnea or other symptoms of hypoxemia occur, you should also go to the hospital immediately. It is not advisable to use an oxygen generator to inhale oxygen at home. Excessive oxygen concentration or prolonged inhalation can easily lead to oxygen poisoning. cause danger.

Precautions for purchase

　　Oxygen concentration is the core index of oxygen generators. YY/T 0298-1998 "General Technical Specifications for Medical Molecular Sieve Oxygen Generation Equipment" requires that the oxygen concentration of oxygen generators should be ≥ 90% (v/v), oxygen should be odorless, and the moisture content ≤0.07g/m3, carbon dioxide content ≤0.01% (v/v).

　　Regarding the noise of oxygen concentrators, YY 0732-2009 "Safety Requirements for Medical Oxygen Concentrators" stipulates that under normal use conditions, the maximum noise of an oxygen concentrator should not exceed 60dB.

YY/T 0298-1998 "General Technical Specifications for Medical Molecular Sieve Oxygen Production Equipment" requires that the noise of oxygen production equipment should not exceed 85 dB.

　　YY 0732- 2009 "Safety Requirements for Medical Oxygen Concentrators" also stipulates that the gas temperature at the outlet of the oxygen concentrator should not exceed the ambient temperature by 6°C.

The maximum gas temperature should not exceed 46°C to avoid thermal damage to the human body caused by the gas.

　　As an ordinary consumer, before choosing to purchase an oxygen generator, you should consult a professional doctor for advice, correctly understand the oxygen inhalation time and oxygen inhalation flow requirements for your indications, and then choose the appropriate model product, and use it reasonably according to the instructions. .

(Source: Shanghai Institute of Quality and Standards) (China New Finance and Economics)