Disposable Hemoperfusion Cartridge, hemoditoxifier, medical consumables for sale (MSLGL08)

Introduction of MG Therapy

The main focus of MG therapy is the removal of inflammatory mediators, particulary cytokines and chemokines, from the patient's blood. The MG cartridge removes a vide range of inflammatory mediators between a 10-63 kDa molecular weight range, where most cytokines can be found. Standard high-flux dialysis or CRRT is only capable of removing substances generally below 15kDa in size.

As a result of the MG therapy, life-threatening complications associated with the cytoline storm can be avoided, and stabilization after a hyperinflammatory phase improved.

Mechanism

The mechanism of hemoperfusion is based on biocompatible and highly porous polymer beas which allow to remove a wide range of toxic substances such from the blood, such as drugs, cytokines and toxins, by combining functions of the pore structure, Van der Walls Force and hydrogen bond.

• blood flow 180-400ml/min
• pre-filled with water for injection
• steam sterilized, 3 years shelf life
• size selectivity <63 kDa
• low flow resistance
• blood volume 150-190ml

1.Product Specification

Product specifications are named after adsorbent volume (mL).

2. Functional description

2.1 Appearance: The shell of the adsorption column should be transparent, the inner and outer

shell surface is smooth.

2.2 Blood compartment volume: See 1 .4

2.3 Particle shedding: In the 100mL test solution of the adsorption column, and the number of the

15 um ~ 25 um particles is less than 200, and the number of particles greater than 25um in the

100mL test solution is less than 100.

2.4 Reducing material: 20mL test solution and [c (KMnO 4 ) =0.002mol/L] of the same batch of blank

solution should be no more than 2.0mL

2.5 Metal ion: When using a colorimetric assay, showing the test liquid color should not exceed the

concentration of c(Pb 2+ ) =1 ug/mL standard solution

2.6 pH value: The difference between the pH value of the test solution and the blank control

solution should be no more than 1.5

2.7 Evaporation residue: The total amount of evaporation residue in 50mL test liquid should be no

more than 2mg

2.8 UV absorbance: Less than 0.1

2.9 Sterile: The column is sterile

2.10 Bacterial endotoxin: Less than 0.5EU/mL

2.11 Sealing performance: The positive pressure in the blood compartment of the adsorption

column is 100kPa.

2.12 Adsorption property:

Adsorption properties of pentobarbital sodium: Drop rate of concentration is no less than 80%

Adsorption properties of creatinine: Drop rate of concentration is no less than 15%

Adsorption properties of Vitamin B12: Drop rate of concentration is no less than 80%

Adsorption properties of β 2-microglobulin: The adsorption capacity is more than 0.3mg/mL

Adsorption properties of parathyroid hormone (PTH): The adsorption capacity is more than

0.4pmol/mL

2.13 Temperature resistance: The adsorption column should not be deformed and cracked in the

range of 0 ~50 º C.

3. Classification

Class IIb, according to MDD Annex IX , rule 3, “ All non-invasive devices intended for

modifying the biological or chemical composition of blood, other body liquids or other liquids

intended for infusion into the body are in Class IIb ”