HSY PRODUCT

The operating instruction manual of the Urine analysis of quality control

Contact +8615811248643 Kita Wang

【The product name】

The product name：Urine analysis of quality control   The English names：Urinelysis control

【packing specification】

Negative quality content   Positive quality content

【Intended use】

Urine constitution control material (hereinafter referred to as the quality control material) used for the quality control of urine test paper and urine analysis instrument, can to glucose, bilirubin, ketone body, specific gravity, occult blood, PH, protein and uric bravery former substitutes, nitrite, white blood cells, can also be used for analysis of urine test paper human reaction, make the urine analysis test paper produce color change.

【The main components】（W/W）

Negative quality control: urea 0.2%, 0.5% sodium chloride, Phosphate buffer of 0.2%, Other than 97.3% reaction substance and stability

Positive quality content:0.2% phosphate buffer, Glucose 1.0%, Sodium chloride 0.5%, Hemoglobin 0.1%, 0.7% bovine serum albumin, Acetoacetic ester 0.9%, 0.3% sodium nitrite, Esterase 0.5%, The urea 2%, Other than 93.9% reaction substance and stability

【The Storage conditions and the period of validity】

The Quality content under the condition of 2-8 degrees seal avoid light preservation, valid for 12 months, after opening in sealing preservation conditions valid for one month

【Applicable instrument】Urine analyzer Specific see table reference range

【The method of use】

1. When using the quality control material return to room temperature (18 to 25 degrees), and put the bottle upside down gently several times to control the quality will be thoroughly incorporated
2. The use of the semi-automatic urine analyzer: put the instrument to control the quality to test state, will quality content drops in the test paper, dripping with quality content test article about up, along the test piece with absorbent paper side absorb redundant quality content, blotting paper not touching the test piece, lest produce cross-contamination, and then strip in instrument test position for testing
3. The use of fully automated urine analyzer: the instrument to quality control test status, the quality control of things into a clean tube and tube on the test position adaptation instrument for testing

【The interpretation of the test results】

The Urine analysis strip outside the various test results should be within the scope of the quality control object reference, if the test result is beyond the scope of reference, to the comprehensive analysis on the test system, find the reasons

【The limitations of testing method】

The Quality of crystallization of bilirubin and uric bravery former chemical substitutes, the chromogenic reaction with clinical urine samples of bilirubin and uric bravery former color is slightly different.

【The Matters needing attention】

Drop the quality content can be recycled into the bottle, lest produce cross-contamination

When using, should avoid contact with skin, such as contact, rinse with water immediately

Tighten the cap immediately after using, save 2-8 degrees Celsius

【Identity interpretation】

【reference documentation】

ZL11  1  28009.3 《Urine analysis quality control material and preparation method》

【The basic information】

Registered person /or Name of production enterprise： Beijing HuaShengYuan medical technology co., LTD

Address: Changping District, Beijing science and Technology Park torch street, No. 21

Contact information: telephone 010-87589645 fax: 010-87589646

Service hotline: 4001106660

Zip code: 102600

Production address: Daxing Industrial Development Zone of Beijing City Sheng Fang Road No. 1 Sanli Industrial Park No. 2 floor 2 West

Production license number: Beijing Pharmaceutical machinery production of 20060039

【Medical device registration certificate No. / Product technical requirements number】

【pecification approval date and revision date】

Approved date

【Reference range】