User’s Manual for Hollow Fiber Hemodialyzers 0123

No. JK/GY-JS02.01(E)-2014 Rev. B/1 Revision Date: Dec. 20th, 2018

【Name of Product】
Hollow fiber hemodialyzer
【Type of Product】
LoF10, LoF12, LoF14, LoF16, LoF18, LoF20.
【CFDA Permit for Medical Devices Production Enterprise】
CFDA medical device registration certificate No. 20183450080.
CFDA production license No. 20140068, issued by Suzhou Food and Drug Administration.
【Product structure and compositions】

Dialysis membrane: polyether sulfone membrane; housing and blood cap: polycarbonate (PC); O-ring: medical silicon
rubber; sealants: Polyurethane (PU) rubber; protector caps: high-density polyethylene (HDPE).
【Application scope】
The product is applicable to patients with acute or chronic renal failure for dialysis and can only be used under guidance
of a doctor.
【Contraindications】
No absolute contraindication.
Relative contraindications: severe low blood pressure and shock; pulmonary edema and heart failure caused by severe
myocardial lesions; severe arrhythmias; severe bleeding tendency or cerebral hemorrhage; advanced malignant tumor;
patients with extreme failure; uncooperative psychiatric patients; patients allergic to this product; patients or their family
members refusing to use the product.
【Adverse reactions】
Please consult your doctor in charge in case of adverse reactions.
In the dialysis process, allergic reactions may occur to some patients, and specific signs and symptoms include nausea,
vomiting, itching, malaise, unusual sweating, hives, generalized or local skin redness, swelling of the face or hands, high
blood pressure, low blood pressure, increased pulse rate, arrhythmia, bloodshot eyes and the like.
Side effects may be associated with insufficient or excessive blood to chamber, i.e., nausea, vomiting, high blood
pressure and low blood pressure, which usually can be avoided by careful management of the patient's fluid, electrolyte
balance, blood flow velocity and transmembrane pressure (TMP).
【Anti-clotting】
Use of anticoagulants need to be adjusted according to the specific circumstances of the patient who should follow the
advices of his/her doctor in charge on the type of use, usage, management of anticoagulants.

【Recommended operational steps】

Pre-dialysis cleaning:
Vertically fixed the dialyzer, keep the blood inlet end down, and connect arterial blood tubing with the saline bottle.
Connect blood tubing with the blood inlet and outlet ends of the dialyzer tubing (using a 6% Luer connectors to match
with the dialysis machine), start the blood pump to inject saline into the dialyzer (recommended dosage: 1000 ml) in
order to completely discharge air bubbles. Stop the blood pump working, make the dialyzer 180-degree reversal,
connect the dialysate connection fitting (using Hansen connector to match with the dialysis machine) to keep inlet at the
low-end and outlet at the high-end, and control dialysate flow at about 500 ml/min.
（or : The priming volume of the dialyzer must be minimum 500 ml. It is recommended to circulate the extracorporeal
circuit after priming with saline or dialysate with a blood pump speed of 100 ml/min for a time span of 10 minutes）

Priming:
Prime 500 ml heparin saline (about 10 mg heparin or following the advice of your doctor) in order to heparinize blood
tubing for dialysis use.
Connection with patients:
Connect arterial blood tubing with the patient’s circulatory system to make blood flow into the tubing and the dialyzer.
Connect venous blood tubing with the patient. Adjust treatment parameters to the desired set point.
Termination:
Clamp arterial blood tubing at the connecting point with the patient, remove the tubing from the patient and then
connect the tubing with the saline infusion tubing. Release the clamping completely to make full blood back-streaming
to the patient. Clamp venous blood tubing at the connecting point with the patient and remove the tubing from the
patient.

【Precautions and warnings】

 Transmembrane pressure should be 66.5 kPa (500 mmHg) or below, and undue pressure cannot be exerted inside
the blood tubing and the dialyzer so as to prevent leakage and falling off of the connecting.
 The recommended dialysate flow rate should be 500 ml/min. The recommended blood flow rate should be: LoF10,
100-300 ml/min; LoF12 ~ LoF18, 200-400 ml/min; LoF20, 200-500 ml/min.
 In the process of washing and pre-filling, air must be strictly prevented from coming into the dialyzer and the blood
tubing; in the flush process, there may be some liquids discharging from the dialysate port.
 This product needs using in conjunction with the dialysis machine equipped with precision flow control system, in
order to complete dialysis together with dialysis equipment and blood tubing. Because the dialyzer has a higher
ultrafiltration rate, the operator must carefully monitor the patients until the patients adapt themselves to the dialyzer.
In the entire treatment process, amount of filtering needs to be carefully adjusted to avoid insufficient or excessive
ultrafiltration which will make the patient uncomfortable.
 Known adverse reactions and general or specific contraindications adverse reactions are detailed in [Adverse
reactions] and [Contraindications] respectively. The product should be used under the guidance of the medical
workers who is familiar with the patient’s case and dialysis operations.
 Clotting may occur when the blood flow rate is below 80 ml/min. Please use this product at the recommended
blood flow rate.
 Due to the inherent filtration, the dialysate may enter the dialyzer’s blood compartment under low ultrafiltration rate
circumstance. Therefore, the dialysate and dialysis water used must comply with the relevant dialysis requirements.
 Do not use on non-deaerated dialysis fluid delivery systems.
 Medical workers need to select the appropriate dialysis fluid according to the characteristics of patients and monitor
the changes of the physical signs in the treatment process.
 If the carton is damaged, check the product contained carefully. Use of the product is not permitted when one of the
following situations occurs: the packing bag is damaged; the product fell down; protective end caps are not in place.
 Use of the expired dialyzer is not permitted (see product label).
 The product should be strictly sterilized and used as soon as possible after unpacked.
 This product is sterilized by the way of γ-ray radiation, the fluid pathways (blood and dialysis fluid) are sterile and
non-pyrogenicity.
 This product is designed for once use. The Company cannot guarantee safety and shall assume no responsibility if
the product is reused.
 The used product should be destroyed in accordance with the relevant standards for disposal of medical waste.
 Please use the product strictly in accordance with User’s Manual. The manufacturer shall assume no responsibility
for any consequences from the violation of operational steps.
 This product should not be used for any purpose other than dialysis.
 Not recommended for paediatric use.

【Conditions for transportation and storage】

During transportation, this product should be prevented from being exposed to stress, sun, snow and rain and kept from
direct sunlight, high temperature and humidity.
The product should be stored at room temperature, with relative humidity at or below 80%, non-corrosive gases and cool,
dry, well-ventilated, clean environment.

【Period of validity】
Three years since sterilization, see product label.

【Graphic symbols and abbreviations in the label】

Batch code FOR ONCE USE
Fluid pathways sterilized
Serial number
using γ-rays radiation
Period of validity To read user’s manual
European Authorized
Manufacturer
Representative
Broken Packing and No
Date of manufacture
USE

【Connecting sketch for product】

【Technical specifications and indicators】
Table 1 Specification & Performance

Model & Specification LoF10 LoF12 LoF14 LoF16 LoF18 LoF20

Inner diameter of membrane (μm) 200
Wall thickness of membrane (μm) 40
Max. operation pressure (kPa/mmHg) 66.5/500
Max. flow rate (ml/min) Max. QB=500 ml/min，Max. QD=500 ml/min
Effective membrane area (m² ) 1.0 1.2 1.4 1.6 1.8 2.0
UFR (ml/h·mmHg) 15 18 22 25 28 30
Blood compartment volume (ml) 70 78 85 98 110 125
Test condition QB=200 ml/min
Urea 186 188 190 192 194 196
Creatinine 175 178 181 184 187 190
Phosphate 165 170 175 180 185 189
Vitamin B12 88 100 110 118 126 133
Test condition QB=300 ml/min
Urea 238 245 252 260 267 275
Clearance rate Creatinine 206 220 233 245 257 270
Phosphate 192 203 214 225 235 245
Vitamin B12 92 104 120 136 150 165
Test condition QB=400 ml/min
Urea 256 268 279 290 300 312
Creatinine 235 248 261 275 288 300
Phosphate 218 230 244 257 270 283
Vitamin B12 95 110 125 142 158 173
Sterilization γ-rays
Note: Vitro performance parameter condition for UFR: QB=200 ml/min, TMP=100 mmHg, T=37℃, test by anticoagulation bovine plasma,
total protein content 60±5 g/L.
Vitro performance parameter condition for clearance rate: QD=500 ml/min, QF=10 ml/min, T=37℃, test by simulated body fluid (EN
1283).

Manufacturer and service unit: The European Union representative name:

Suzhou Jun Kang Medical Technology Co., Ltd. Shanghai International Holding Corp. GmbH (Europe)
Production and registered address: Address:
No. 28, Wutaishan Road, SND, Suzhou, Jiangsu, China Eiffestrasse 80, 20537 Hamburg, Germany
Postcode: 215163 Tel: +49-40-2513175
Tel: +86-512-69583808 Fax: +49-40-255726
Fax: +86-512-69583808