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disposable lancing auxiliary kit

  • product description
  • performance and use

[product name] disposable blood collection kit.

[specifications] type i, type ii.

[name of registrant] henan jianqi medical equipment co. ltd.

the dingluan industrial zone in changyuan county.

[contact number] 0373-8690789.

[after-sales service unit] henan jianqi medical equipment sales co., ltd.

[name of production enterprise] henan jianqi medical equipment co., ltd.

the dingluan industrial zone in changyuan county.

[production address] dingluan industrial zone, changyuan county.

[contact information] 0373-8690789.

[production license] the food and drug regulatory apparatus is permitted to be made in 20080036.

[registration certificate no.] yu ordnance mark 20142640124.

[technical requirements no.]


[structure and composition] the product consists of basic configuration and selection configuration; type i basic configuration: medical cotton swab, medical infusion paste; type ii basic configuration: medical cotton swab, tray; type i and type ii choose configuration by: medical cotton ball, hemostatic adhesive tape, medical cloth, disposable towels, pe examination gloves, disposable single, iodine in v cotton swabs, iodine v cotton ball, athletic tape, medical forceps, tray.

[product performance] 1. the name, specification and quantity of the items in the blood collection auxiliary package shall conform to the requirements in table 1 and table 2 of the product technical requirements. 2. the blood collecting auxiliary packing should be well sealed, with no gaps and no holes; no damage, no stain and no impurities should be found in all accessories in the blood collection. folded parts should be folded neatly. 3. the specification and size of the medical cotton swab and the weight of the cotton swab can be seen in the product technical requirements in table 3. 4. the surface of the cotton head should be clean without stains or impurities. the surface of the bamboo stick should be smooth and without burrs. the bamboo stick and the end of the cotton head should be tightly twisted, not naturally falling off; the appearance of the absorbent cotton should be free of leaves, skins, seeds, residues or other impurities. when stretching, there must be some resistance. each visible fiber should be composed of a single cell with a maximum length of 4cm and a maximum width of 40 m. it is a thick, round, flat tubular shape, usually twisted. when contact with iodized zinc chloride solution, the fiber should be purple; the sample should not be dissolved; only typical cotton fibers should be included, allowing occasional small, isolated foreign fibers to exist; the number of samples should not be more than standard; the total amount of soluble substance should not be greater than 0.50%; the solution should not be pink; the sinking time shall be no more than 10s; the absorbance should not be less than 23.0g per gram of absorbent cotton. the total amount of soluble in ether should not be greater than 0.50%; the medical absorbent cotton should only be microscopic brown and purple fluorescence and a small amount of yellow particles. in addition to a small amount of isolated fiber, should not show strong blue fluorescence; the quality of dry weight loss should not be greater than 8.0%; sulfate ash should not be greater than 0.40%; surface active substance foam should not cover the entire liquid surface; leaching of coloring matter in extraction device of a long and narrow, with 96% ethanol (volume fraction is 95.1% ~ 96.9%, about 0.81 g/ml) put forward 50 ml of 10.0 g cotton wool slowly leaching leaching solution, the leaching solution color should be deep in appendix a controlled liquid y5, gy6 or reference solutions according to the following methods: 3.0 ml to primary blue solution with 7.0 ml of hydrochloric acid solution (mass concentration of 10 g/l hydrochloride), using hydrochloric acid solution (mass concentration hydrochloric acid of 10 g/l) 0.5 ml of the solution will be diluted to 10.0 ml. 5. the medical infusion should be the qualified product of the medical device registration certificate. hemostatic tape should be cut neatly; the tensile length and fracture strength should be more than twice their own and no fracture. if the medical package is made of hot pressure, the hot pressing part should be firm and not cracked; the specification of non-woven fabric shall not be less than 20g/m2; the longitudinal fracture strength should be greater than or equal to 13n, and the transverse fracture strength should be greater than or equal to 8n. the disposable therapeutic towel shall be a qualified product to obtain the medical device registration certificate. 9pe inspection gloves shall be qualified products obtained from medical device registration certificate. 10 one-time use should be the qualified products that obtain medical device registration certificate. 11 iodized cotton swabs shall be eligible for medical device registration certificate. the iodized cotton ball shall be a qualified product for obtaining the medical device registration certificate. the air duct tape shall be a qualified product for obtaining the medical device registration certificate. the medical forceps should be symmetrical, the exterior should be smooth, not have front edge, burr, crack, hemp point, trachoma; tweezers should have good elasticity; the two pieces of the tweezers should be strong enough to withstand the tensile force of 15n. no fracture should be observed. the teeth should be clear and complete, and there should be no shortage of teeth or teeth. the guiding pin and positioning pin of tweezers should be firmly fixed. when the tweezers are open and closed, they should be flexible and should not be jammed. the handle of the tweezers should be clear and complete. there should be no flowers or flowers. 15 tray should be smooth, without burr and injection flow; thickness shall not be less than 0.1mm. 16. sterile blood collection aids should be sterile. the residual amount of epoxy ethane was sterilized by ethylene oxide, and the residual amount of ethylene oxide should not be greater than 10 g/g.

[applicable scope] used in clinical auxiliary blood collection of medical units.

contraindication: no absolute contraindication.

1. this product is a disposable product, which is damaged in packaging and is strictly prohibited to be used and destroyed after use.

2. see packaging seal or label on the production batch number, and the sterilization date is in the outer packing box.

3. this product is sterilized by ethylene oxide.

[use method] 1. select the applicable patient's specifications and model, and then open the package after the outer packing is in good condition.

2. take out the accessories according to the clinical needs.

3. after the product is finished, it should be treated with medical waste to avoid pollution.

[storage method] 1. this product is used in the carriage and hold of the cabins, and is kept clean, without pressure, sunshine and rain and snow.

2. handle gently in handling and avoid violent collision;

3. the product shall be stored away from the fire source, and the relative humidity shall not exceed 80%, without corrosive gas and well-ventilated and clean environment.

[production date] see packaging seal or label.

expiry date: see packaging seal or label.

[label, package logo]

[specification preparation date] august 24, 2017.


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