CE / ISO Approved Medical Equipment Haemodialysis Device For Hospital Use

CE/ISO approved Haemodialysis Device Use for Hospital

 

Brief introductions

Introductions on the HD device

1. Product name: hemodialysis device

2. Standard No. of product: YZB/National 1305-2013 Hemodialysis Device

3. Application: Hemodialysis Device is used for Hemodialysis on patients with acute or chronic kidney failure.

4. Performance, structure and components of the product: the product consists of dialysate supplysystem (dialysis pump, ultrafiltration pump, proportion preparation unit, liquid constanttemperature unit, transmembrane pressure monitoring and conductivity monitoring) and bloodcirculation system (blood pump, heparin pump, arterial-venous pressure monitoring, air bubblemonitoring and blood leakage monitoring), without the disposal sterile consumables used withthe device included.

5.Hemodialysis Device can be used in various medical centers and for clinical use.
When Hemodialysis Device is conducting HD treatment, it runs and monitors the dialysate circulation and extracorporeal blood circulation.

6. All the operation menu and running status of Hemodialysis Device is displayed on the color LCD screen.

7. Hemodialysis Device uses hydrogen carbonate and acetate for HD treatment.

8. Hemodialysis Device With single needle dialysis function(optional function).

9. Hemodialysis Device should be connected to the RO water treatment

10. In the circulation, after heating and air removing, the dialysate is conveyed to the dialyzer, which keeps the flow-in fluid and flow-out fluid equal in volume. According to the selected UF rate, the necessary UF volume for treatment can be achieved.

11. In the extracorporeal blood circulation, the blood goes through the dialyzer. The air inspector can prevent the air entering. The blood leakage inspector and venous pressure inspector can prevent the blood loss.

12. The mixing proportion of hydrogen carbonate concentrate and RO water is 1:1.225:32.775(A:B:water). The manufacturer can customize the mixing proportion according to the user’sdemand.

13. Based on the requirement of treatment, the concentration of Na＋ can be adjusted in the range of 136mmol/L~145 mmol/L.

14.Hemodialysis Device can conduct pure UF (ISO UF)/ single needle-7-treatment(optional function)/double needle treatment .

15.Hemodialysis Device can conduct rinse, hot disinfection, and disinfection procedures to complete automatic cleaning and disinfection.

16. The flux of dialysate can be adjusted within the range of 300 ml/min~800 ml/min.

17.Hemodialysis Device is equipped with a safety monitor system that ensures the safety of patients. Extracorporeal blood-losing protection system meets with GB9706.2 “The part 2~16 for Medical 18. Electronic Device: safety requirement for hemodialysis, hemodiafiltration and hemofiltration”.

 

Main technical specifications

1. Dimension: Height: About 145 cm (Fluid stand is not included)

Width: About 34 cm

Length: About 37 cm (Foot is not included)

Area: About (56.3×62.5) cm2

 

2. Weight: About 90 kg

 

3. Electric safety

Electric shock resistance type: Category I

Electric shock protection degree: Type B Symbol:

Liquid incursion protection: Anti-dripping Symbol: IPX1

 

4. Work system: continuous running

 

5. Power supply

Line voltage: AC220V, Frequency 50/60Hz

Input power: 1700W

 

6. Fuse: 2×10A(Ф6×30)

Main switch: C65N 32A AC250V

 

7. Working condition

Flow-in water pressure: 0.1 MPa~0.6 MPa (Standard)

The quality of reverse osmosis water conforms to standard YY0572-2005.

Flow-in water temperature: 5℃~35℃

Working environment: Temperature 10℃~38℃, with relative humidity not greater than 80% atmospheric pressure 70kPa~106kPa.

Drainage: 0~100cm higher than the ground surface

Concentrate supply: Maximum suction height of 75 cm

Temporary idle period: It is recommended to disinfect the device before the HD device temporarily stops working. And hot disinfection the device before the device resumes working.

Storage temperature: 5℃~40℃ (without using anti-freeze)

-10℃~40℃(with the water pipeline being emptied)

Stability: 10º

 

8.Restrain hearable alarm: The silent time of alarm is 2 minutes.

New alarm can activate mute alarm

 

9. Working procedure

Function test: Automatic test on the safety system after powering on.

Rinse the system lines: In “Rinse” status, the device automatically rinse the system lines.

HD: Hemodialysis with hydrogen carbonate and acetate

Sequential UF: UF/Pure UF(ISO UF) without flow of dialysate

Cleaning procedure: Including Chem.Dis, hot disinfection, rinse three modes.

Disinfect mode is devided into “Citric acid” and “Peracetic acid”.

Rinse mode includes the options of cold rinse and hot rinse

Hot disinfection mode is devided into “Heat + Citric acid” and “Heat”.

 

10. Dialysate circulation and safety system

Blood leakage inspector: Method: Photo electricity inspection

Reaction threshold value: When red blood cell rate is 0.32±0.02, the blood lead age of each liter of dialysate is equal or over 1ml (flow rate of dialysate is 500 ml/min)

TMP: Display range: -100 mmHg~+600 mmHg

Error: ±20 mmHg

Width of warning window: Adjustable in the range of -100 mmHg ~ +600 mmHg

UF: ISO UF flow rate: 0~4000ml/h

HD flow rate: 0~4000ml/h

UF preset range: 0~16000ml

UF precision: ±30 ml/h or ±1%, whichever is greater (absolute value)

Concentration of dialysate Display range: 0 mS/cm~15.8 mS/cm (conductivity) Error: 0.1 mS/cm

Hydrogen carbonate: Standard setting (Otional) : 1:1.225:32.775

1:1.830:34.000

1:1.830:34.000

1:2.100:34.000

The concentration of NaCl contained in liquid B between the second ratio and the third ratio is different.

Na+ adjustment range: 136 mmol/L~145 mmol/L

 

11. Cleaning procedure:

Rinse: Temperature of clod rinse Ambient temperature (10 min)

Temperature of hot rinse 50℃~90℃ (10 min, without heating time)

Disinfection: Time: 36 min for working mode “citric acid”

31 min for working mode “peracetic acid”

Hot disinfection: Time: 42 min for working mode “heating + citric acid”

32 min for working mode “heating”

 

12. Flow Dialysate flow: 300ml/min~800ml/min

Error: +10% -5%

 

13. External blood circulation and safety system

Blood pump: Rang of flow rate: 20ml/min~460 ml/min(ID Ф 6 mm)

20 ml/min~620 ml/min(ID Ф 8 mm)

Error: ±10％ or ±10mL/min, whichever is greater (absolute value) (pressure at blood outlet: -300mmHg ~ 0mmHg)

Pump tube diameter: Ф 6 mm, Ф 8 mm

Equipped with a spare pump, the technic data is the same with those which are regulated by the blood pump.

Arterial pressure: Display range: -300 mmHg~+400 mmHg

Error: ±20 mmHg

Alarm: Adjustable within the range of -300 mmHg~+400 mmHg

Venous pressure: Display range: -50 mmHg~+300 mmHg

Error: ±10 mmHg

Alarm: Adjustable within the range of 10 mmHg~300 mmHg

Heparin pump: Range of flow rate: 0.1 ml/h~10 ml/h

Resolving rate: 0.1 ml/h

Error: 5％ or ±0.2mL/h, whichever is greater (absolute value)

Injection duration: 0~9:59

Syringe size: 10 ml / 20 ml / 30 ml

Blood level inspector: Method: Ultrasonic transportation

Air bubble inspector: Method: IR inspection

Reaction threshold: Under blood flow rate of 200 ml/min, single

air bubble of 200μl appears.

Sound alarm: It’s adjustable within the range of 65~72 dB

The cycle of sound alarm is one per second, the intermittent silence is 0.5 second.

 

14. Blood way lines and dialysate are universal with Fresenius and Toray.

 

15. Backup power supply Lead acid battery (maintenance-free) 24V(2×12V)/ 7Ah

 

16. Hemomanometer The value indicates the measured pressured value and pulses.

Operation temperature/humidity: temperature 10℃~38℃, relative humidity ≤80%, atmospheric pressure 70kPa~106kPa.

Storage temperature/humidity: relative humidity ≤80%, in the room without caustic gas and with good ventilation.

Measurement range: pressure 0~299mmHg

Cuff of hemomanometer: class I Defibrillation-proof: type BF

Measurement range of pulse: 40/min~180/min