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Requires/anaerobic flasks (fluorescence/colorimetry)

Requires/anaerobic flasks (fluorescence/colorimetry)

(Summary description)

【product name】

Generic Name: Necessary/Anaerobic Culture Flask (Fluorescence/Colorimetry)

【Packaging Specifications】

Model: Type I aerobic culture flask, type II anaerobic culture flask, type III aerobic children culture flask, type IV aerobic L-type culture flask;

Specifications: 25 servings/box, 100 servings/box, 200 servings/box.

【expected usage】

For clinical bacteremia, septicemia patient blood and sterile body fluid samples for the detection of aerobic/anaerobic bacteria.

【Inspection Principle】

The culture bottle contains peptone, yeast powder, vitamins and other nutrients, which can provide higher nutrients and growth factors for the growth and reproduction of bacteria, because the growth of bacteria in the medium will produce carbon dioxide. The growth and reproduction of bacteria produces carbon dioxide that can change the color of the sensor at the bottom of the culture bottle from blue-green to yellow, and the growth of bacteria can be judged by detecting changes in fluorescence or color.

【Main components】

It is mainly composed of a cylindrical transparent container and a butyl rubber airtight cover. The material of the container is polyethylene, and a carbon dioxide sensor is attached to the bottom of the container. The liquid bacterial culture medium and gas are stored in the container. 

The main components of the culture medium:

Aerobic culture bottle: peptone 10g, yeast powder 4g, brain heart extract powder 4g, vitamin B6 0.01g, SPS 0.015g, ion adsorption resin 4g/bottle, X factor 0.005g, fluorescent indicator 10mL.

Anaerobic culture flask: peptone 10g, yeast powder 4g, brain heart extract powder 4g, vitamin B6 0.01g, SPS 0.015g, X factor 0.005g, ion adsorption resin 4g/bottle, sodium thioglycolate 1g, fluorescent indicator 10mL.

【Storage conditions and validity period】 Store in the dark at 15~30℃, and the validity period is 12 months.

【Applicable instruments】

Applicable to the fully automatic blood culture system produced by Zhuhai Meihua Medical Technology Co., Ltd.

【Sample requirements】

1. It is very important to collect specimens correctly during bacterial culture. Correct specimen collection methods and reasonable skin disinfection are the basic needs to reduce contamination. Culture flasks

Mark the corresponding patient information and vaccination time on it.

2. Disinfect the mouth of the bottle with 75% alcohol to prevent the contamination of patient specimens.

3. Aseptically collect 5-10ML specimen (1-3ML for aerobic children's culture bottle) and inject it into the culture bottle, and inject a sufficient amount of specimen according to the indication line on the bottle label.

Send it to the laboratory as soon as possible after inoculation.

【Testing method】

1. Check the culture bottle before use

Before use, the medium in the culture bottle is a clear and transparent liquid. If the medium is found to be turbid, precipitated (except for resin) and gas production, it means that the medium may be contaminated and cannot be used.

2. Instructions for use

1) Check the bottle with the naked eye during the culture process. The bottle with haemolysis and turbidity and the color change at the bottom shall be treated as a positive bottle.

2) All the culture flasks reported as positive should be smeared. If the smear is negative, continue to culture. If there is no bacterial growth after 7 days of culture, it can be reported as negative.

3) Negative culture flasks can be re-smeared before discarding to rule out false negatives.

【Explanation of test results】

Manual interpretation: After inoculation, put the culture bottle into a 35-37 ℃ incubator for culture, and observe once a day in the morning and evening. Confirmed by smear or seed transfer. No color change at the bottom of the culture bottle, no turbidity, precipitation, gas production and other phenomena in the culture medium, and it is judged as a negative result.

Instrument interpretation: refer to the automatic blood culture system produced by Zhuhai Meihua Medical Technology Co., Ltd. and follow the operating instructions.

[Limitations of the test method]

1. The test results largely depend on the collection of specimens. The number of bacteria in the blood is very small, and may appear in the blood intermittently. At this time, the patient needs to collect blood multiple times to improve the positive detection rate.

2. Bacteria can be seen on the smears of positive specimens, but they do not grow when inoculated with conventional medium. These specimens should be transplanted to medium in which suspected bacteria can grow.

   superior.

3. In individual cases, some fastidious bacteria cannot grow in aerobic or anaerobic medium, and this fastidious bacteria requires special medium and special culture conditions.

4. In rare cases, there are individual bacteria that grow in the medium, but cannot produce enough carbon dioxide to change the color of the bottom of the culture bottle, resulting in

False ne

Requires/anaerobic flasks (fluorescence/colorimetry)

(Summary description)

【product name】

Generic Name: Necessary/Anaerobic Culture Flask (Fluorescence/Colorimetry)

【Packaging Specifications】

Model: Type I aerobic culture flask, type II anaerobic culture flask, type III aerobic children culture flask, type IV aerobic L-type culture flask;

Specifications: 25 servings/box, 100 servings/box, 200 servings/box.

【expected usage】

For clinical bacteremia, septicemia patient blood and sterile body fluid samples for the detection of aerobic/anaerobic bacteria.

【Inspection Principle】

The culture bottle contains peptone, yeast powder, vitamins and other nutrients, which can provide higher nutrients and growth factors for the growth and reproduction of bacteria, because the growth of bacteria in the medium will produce carbon dioxide. The growth and reproduction of bacteria produces carbon dioxide that can change the color of the sensor at the bottom of the culture bottle from blue-green to yellow, and the growth of bacteria can be judged by detecting changes in fluorescence or color.

【Main components】

It is mainly composed of a cylindrical transparent container and a butyl rubber airtight cover. The material of the container is polyethylene, and a carbon dioxide sensor is attached to the bottom of the container. The liquid bacterial culture medium and gas are stored in the container. 

The main components of the culture medium:

Aerobic culture bottle: peptone 10g, yeast powder 4g, brain heart extract powder 4g, vitamin B6 0.01g, SPS 0.015g, ion adsorption resin 4g/bottle, X factor 0.005g, fluorescent indicator 10mL.

Anaerobic culture flask: peptone 10g, yeast powder 4g, brain heart extract powder 4g, vitamin B6 0.01g, SPS 0.015g, X factor 0.005g, ion adsorption resin 4g/bottle, sodium thioglycolate 1g, fluorescent indicator 10mL.

【Storage conditions and validity period】 Store in the dark at 15~30℃, and the validity period is 12 months.

【Applicable instruments】

Applicable to the fully automatic blood culture system produced by Zhuhai Meihua Medical Technology Co., Ltd.

【Sample requirements】

1. It is very important to collect specimens correctly during bacterial culture. Correct specimen collection methods and reasonable skin disinfection are the basic needs to reduce contamination. Culture flasks

Mark the corresponding patient information and vaccination time on it.

2. Disinfect the mouth of the bottle with 75% alcohol to prevent the contamination of patient specimens.

3. Aseptically collect 5-10ML specimen (1-3ML for aerobic children's culture bottle) and inject it into the culture bottle, and inject a sufficient amount of specimen according to the indication line on the bottle label.

Send it to the laboratory as soon as possible after inoculation.

【Testing method】

1. Check the culture bottle before use

Before use, the medium in the culture bottle is a clear and transparent liquid. If the medium is found to be turbid, precipitated (except for resin) and gas production, it means that the medium may be contaminated and cannot be used.

2. Instructions for use

1) Check the bottle with the naked eye during the culture process. The bottle with haemolysis and turbidity and the color change at the bottom shall be treated as a positive bottle.

2) All the culture flasks reported as positive should be smeared. If the smear is negative, continue to culture. If there is no bacterial growth after 7 days of culture, it can be reported as negative.

3) Negative culture flasks can be re-smeared before discarding to rule out false negatives.

【Explanation of test results】

Manual interpretation: After inoculation, put the culture bottle into a 35-37 ℃ incubator for culture, and observe once a day in the morning and evening. Confirmed by smear or seed transfer. No color change at the bottom of the culture bottle, no turbidity, precipitation, gas production and other phenomena in the culture medium, and it is judged as a negative result.

Instrument interpretation: refer to the automatic blood culture system produced by Zhuhai Meihua Medical Technology Co., Ltd. and follow the operating instructions.

[Limitations of the test method]

1. The test results largely depend on the collection of specimens. The number of bacteria in the blood is very small, and may appear in the blood intermittently. At this time, the patient needs to collect blood multiple times to improve the positive detection rate.

2. Bacteria can be seen on the smears of positive specimens, but they do not grow when inoculated with conventional medium. These specimens should be transplanted to medium in which suspected bacteria can grow.

   superior.

3. In individual cases, some fastidious bacteria cannot grow in aerobic or anaerobic medium, and this fastidious bacteria requires special medium and special culture conditions.

4. In rare cases, there are individual bacteria that grow in the medium, but cannot produce enough carbon dioxide to change the color of the bottom of the culture bottle, resulting in

False ne

Information

【product name】

Generic Name: Necessary/Anaerobic Culture Flask (Fluorescence/Colorimetry)

【Packaging Specifications】

Model: Type I aerobic culture flask, type II anaerobic culture flask, type III aerobic children culture flask, type IV aerobic L-type culture flask;

Specifications: 25 servings/box, 100 servings/box, 200 servings/box.

【expected usage】

For clinical bacteremia, septicemia patient blood and sterile body fluid samples for the detection of aerobic/anaerobic bacteria.

【Inspection Principle】

The culture bottle contains peptone, yeast powder, vitamins and other nutrients, which can provide higher nutrients and growth factors for the growth and reproduction of bacteria, because the growth of bacteria in the medium will produce carbon dioxide. The growth and reproduction of bacteria produces carbon dioxide that can change the color of the sensor at the bottom of the culture bottle from blue-green to yellow, and the growth of bacteria can be judged by detecting changes in fluorescence or color.

【Main components】

It is mainly composed of a cylindrical transparent container and a butyl rubber airtight cover. The material of the container is polyethylene, and a carbon dioxide sensor is attached to the bottom of the container. The liquid bacterial culture medium and gas are stored in the container. 

The main components of the culture medium:

Aerobic culture bottle: peptone 10g, yeast powder 4g, brain heart extract powder 4g, vitamin B6 0.01g, SPS 0.015g, ion adsorption resin 4g/bottle, X factor 0.005g, fluorescent indicator 10mL.

Anaerobic culture flask: peptone 10g, yeast powder 4g, brain heart extract powder 4g, vitamin B6 0.01g, SPS 0.015g, X factor 0.005g, ion adsorption resin 4g/bottle, sodium thioglycolate 1g, fluorescent indicator 10mL.

【Storage conditions and validity period】 Store in the dark at 15~30℃, and the validity period is 12 months.

【Applicable instruments】

Applicable to the fully automatic blood culture system produced by Zhuhai Meihua Medical Technology Co., Ltd.

【Sample requirements】

1. It is very important to collect specimens correctly during bacterial culture. Correct specimen collection methods and reasonable skin disinfection are the basic needs to reduce contamination. Culture flasks

Mark the corresponding patient information and vaccination time on it.

2. Disinfect the mouth of the bottle with 75% alcohol to prevent the contamination of patient specimens.

3. Aseptically collect 5-10ML specimen (1-3ML for aerobic children's culture bottle) and inject it into the culture bottle, and inject a sufficient amount of specimen according to the indication line on the bottle label.

Send it to the laboratory as soon as possible after inoculation.

【Testing method】

1. Check the culture bottle before use

Before use, the medium in the culture bottle is a clear and transparent liquid. If the medium is found to be turbid, precipitated (except for resin) and gas production, it means that the medium may be contaminated and cannot be used.

2. Instructions for use

1) Check the bottle with the naked eye during the culture process. The bottle with haemolysis and turbidity and the color change at the bottom shall be treated as a positive bottle.

2) All the culture flasks reported as positive should be smeared. If the smear is negative, continue to culture. If there is no bacterial growth after 7 days of culture, it can be reported as negative.

3) Negative culture flasks can be re-smeared before discarding to rule out false negatives.

【Explanation of test results】

Manual interpretation: After inoculation, put the culture bottle into a 35-37 ℃ incubator for culture, and observe once a day in the morning and evening. Confirmed by smear or seed transfer. No color change at the bottom of the culture bottle, no turbidity, precipitation, gas production and other phenomena in the culture medium, and it is judged as a negative result.

Instrument interpretation: refer to the automatic blood culture system produced by Zhuhai Meihua Medical Technology Co., Ltd. and follow the operating instructions.

[Limitations of the test method]

1. The test results largely depend on the collection of specimens. The number of bacteria in the blood is very small, and may appear in the blood intermittently. At this time, the patient needs to collect blood multiple times to improve the positive detection rate.

2. Bacteria can be seen on the smears of positive specimens, but they do not grow when inoculated with conventional medium. These specimens should be transplanted to medium in which suspected bacteria can grow.

   superior.

3. In individual cases, some fastidious bacteria cannot grow in aerobic or anaerobic medium, and this fastidious bacteria requires special medium and special culture conditions.

4. In rare cases, there are individual bacteria that grow in the medium, but cannot produce enough carbon dioxide to change the color of the bottom of the culture bottle, resulting in

False negative.

5. The amount of specimen added to the culture bottle is too much (more than 10ML), resulting in an imbalance in the proportion of the medium, and some bacteria cannot be detected.

6. Occasionally, false positive results are reported due to excessive white blood cells in the specimen, while the results of smear and transplantation are all negative results.

【Product performance index】

1 Accuracy

1.1 Positive accuracy rate

The positive accuracy rate of the culture flask to the inoculated standard strain should be 100%.

1.2 Negative accuracy rate

The negative accuracy of the flasks for inoculation with sterile saline should be 100%.

2 Repeatability

Flasks should be 100% reproducible for inoculated standard strain cultures.

3 within-run imprecision

There should be no difference in the intra-assay imprecision of the culture flasks for inoculated standard strain cultures.

4 Inter-assay imprecision

There should be no difference in batch-to-batch imprecision between the culture flasks for inoculated standard strain cultures.

5 Growth performance

The growth rate of the culture flask to the inoculated standard strain should be 100%.

6 Analytical Sensitivity

The analytical sensitivity of the culture flask to the inoculated standard strain should be ≥103 CFU/ml.

【Precautions】

1. Please pay attention to the validity period and use it within the validity period.

2. Read the instructions carefully before use. If you find that the culture bottle is cloudy, precipitated or discolored before use, it should not be used.

3. Specimens should be collected correctly, timely inoculation of culture medium and standard operating procedures are the keys to improving the positive detection rate and accuracy.

4. This product is only used for in vitro diagnosis and is for one-time use. Please do not use it if the outer packaging is damaged or the writing is unclear.

5. Necessary protective measures must be taken in the operation process to prevent the operator from being infected, and the waste should be treated as the source of infection.

【Explanation of the logo】

: temperature limit.

: In vitro diagnostic medical devices.

: Refer to the instructions for use.

: No secondary use.

【references】

1. Patrick R. Murray, Mannal of clinical Microbiology, 7th edition.

2. Glatt, A.E., W.M.Mc Cormack. and D. Taylor-Robison 1989. Genital mycoplasma , P279-293 in sexually Transmitted Disease, 2nd , McGraw-Hill Book co., New York, N.Y.

3. Wen Yumei, Modern Medical Microbiology, First Edition, Shanghai Medical University Press.

4. Ye Yingwu, Wang Yusan, et al. National Clinical Examination Procedures. Second Edition. Beijing. Department of Medical Affairs of the People's Republic of China. 1997.

 

 

【基本信息】

 注册人/生产企业名称:珠海美华医疗科技有限公司

 住所:珠海市唐家湾镇港湾大道科技一路10号楼副楼三层3B-3单元

 联系方式: (0756)3865699

邮编:519085

电话:(0756)3865688           传真:(0756)3865669     

http://www.meihuayl.com    

售后服务单位名称: 珠海美华医疗科技有限公司

联系方式:400-603-1358

生产地址:珠海市唐家湾镇港湾大道科技一路10号楼副楼三层3B-3单元

生产许可证编号: 粤食药监械生产许20081652号

 

【医疗器械注册证编号/产品技术编号】

医疗器械注册证编号:

产品技术要求编号:

【说明书核准日期及修订日期】 2015年06月01日

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© 2022  Zhuhai Meihua Medical Technology Co., Ltd.  All rights reserved.   粤ICP备2022023050号   SEO