Disposable Haemodialysers(Low Flux) for the hemodialysis treatment

Short Description:

Haemodialysers are designed for the hemodialysis treatment of acute and chronic renal failure and for single use. According to the semi-permeable membrane principle, it can introduce patient’s blood and dialyzate at the same time, both flow in the opposite direction in the both sides of dialysis membrane. With the aid of gradient of the solute, osmotic pressure and hydraulic pressure, The Disposable Haemodialyser can remove toxin and additional water in the body, and at the same time, supply with the necessary material from the dialyzate and maintain electrolyte and acid-base balanced in the blood.


Product Detail

Product Tags

Haemodialysers are designed for the hemodialysis treatment of acute and chronic renal failure and for single use. According to the semi-permeable membrane principle, it can introduce patient’s blood and dialyzate at the same time, both flow in the opposite direction in the both sides of dialysis membrane. With the aid of gradient of the solute, osmotic pressure and hydraulic pressure, The Disposable Haemodialyser can remove toxin and additional water in the body, and at the same time, supply with the necessary material from the dialyzate and maintain electrolyte and acid-base balanced in the blood.

 

Dialysis treatment connection diagram:

 

 

Technical Data:

  1. Main Parts: 
  2. Material:

Part

Materials

Contact Blood or not

Protective cap

Polypropylene

NO

Cover

Polycarbonate

YES

Housing

Polycarbonate

YES

Dialysis membrane

PES membrane

YES

Sealant

PU

YES

O-ring

Silicone Ruber

YES

Declaration: all the main materials are non-toxic,meet the requirement of ISO10993.

  1. Product performance: This dialyzer has reliable performance, which can be used for hemodialysis. The basic parameters of product performance and laboratory date of the series will be provided as follows for reference.Note: The laboratory date of this dialyzer was measured according to the standards ISO8637 

     

    Table 1 Basic parameters of Product Performance

Model

A-40

A-60

A-80

A-200

Sterilization Way

Gamma ray

Gamma ray

Gamma ray

Gamma ray

Effective membrane area(m2)

1.4

1.6

1.8

2.0

Maximum TMP(mmHg)

500

500

500

500

Inner diameter of membrane(μm±15)

200

200

200

200

Inner diameter of housing(mm)

38.5

38.5

42.5

42.5

Ultrafiltration Coefficient(ml/h. mmHg)

(QB=200ml/min, TMP=50mmHg)

18

20

22

25

Pressure drop of blood compartment(mmHg) QB=200ml/min

≤50

≤45

≤40

≤40

Pressure drop of blood compartment(mmHg) QB=300ml/min

≤65

≤60

≤55

≤50

Pressure drop of blood compartment(mmHg) QB=400ml/min

≤90

≤85

≤80

≤75

Pressure drop of dialyzate compartment(mmHg) QD=500ml/min

≤35

≤40

≤45

≤45

Volume of the blood compartment(ml)

75±5

85±5

95±5

105±5

Table 2  Clearance

Model

A-40

A-60

A-80

A-200

Test  Condition :QD=500ml/min,temperature:37±1, QF=10ml/min

Clearance

(ml/min)

QB=200ml/min

Urea

183

185

187

192

Creatinine

172

175

180

185

Phosphate

142

147

160

165

Vitamin B12

91

95

103

114

Clearance

(ml/min)

QB=300ml/min

Urea

232

240

247

252

Creatinine

210

219

227

236

Phosphate

171

189

193

199

Vitamin B12

105

109

123

130

Clearance

(ml/min)

QB=400ml/min

Urea

266

274

282

295

Creatinine

232

245

259

268

Phosphate

200

221

232

245

Vitamin B12

119

124

137

146

Remark: The tolerance of the clearance date is ±10%.

 

Specifications:

Model A-40 A-60 A-80 A-200
Effective membrane area(m2) 1.4 1.6 1.8 2.0

Packaging

Single units: Piamater paper bag.

Number of pieces Dimensions G.W. N.W.
Shipping Carton 24 Pcs 465*330*345mm 7.5Kg 5.5Kg

 

Sterilization

Sterilized using irradiation

Storage

Shelf life of 3 years.

• The lot number and expiry date are printed on the label put on the product.

• Please store it in a well-ventilated indoor place with storage temperature of 0℃~40℃,with relative humidity no more than 80% and without corrosive gas

• Please avoid crash and exposure to the rain, snow, and direct sunlight during transportation.

• Do not store it in a warehouse together with chemicals and humid articles.

 

Precautions of use

Do not use if sterile packaging is damaged or opened.

For single use only.

Dispose of safely after single use to avoid risk of infection.

 

Quality tests:

Structural tests,  Biological tests,  Chemical tests.


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