Manual de Maquina de Dialisis

AMI 11 Dialysis Machine User’s Manual
User’s Manual
For AMI 11 Dialysis Machine
Allmed Medical GmbH

Mittelbacher Str.18, 01896 Pulsnitz, Germany
Tel.:+49 35955 7551-0
Fax:+49 35955 7551-20
Issue date: 01-March- 2012
DFU.017 T026 Page 1 of 145 Rev.01 01-March-2012

contents
1 Safety guidelines ...................................................................................................................... 7

2 Brief introductions .................................................................................................................... 9
2.1 Intended Use ........................................................................................................................... 9
2.2 Indications and contraindications ......................................................................................... 9
2.3 Introductions on the HD device ........................................................................................ 10
2.4 Main technical specifications .............................................................................................11
3 Definition and terms ............................................................................................................... 15
4 Structure and function of HD device ...................................................................................... 16
4.1 Overall structure of HD device......................................................................................... 16
4.2 Components ....................................................................................................................... 21
4.2.1 Structure of blood pump/spare pump ........................................................................... 21
4.2.2 Structure of syringe stand .............................................................................................. 22
4.3 Introduction on extracorporeal blood circulation .......................................................... 23
4.4 Introduction on the water way system ............................................................................. 25
4.5 Introduction on hydrogen carbonate and acetate dialysis ............................................. 29
4.5.1 Connection of concentrate tube ..................................................................................... 29
4.5.2 Supply method of the RO water .................................................................................... 32
4.5.2.1 RO water tube supply.................................................................................................. 32
4.5.2.2 Container supply (selective device) ............................................................................ 32
4.6 The installation of Bi-cartridge ........................................................................................ 33
4.7 Description of combination for Na+ curve graph and UF curve graph ........................ 34
4.8 Introduction on the cleaning procedures ......................................................................... 35
4.9 Menu description ............................................................................................................... 35
4.9.1 Screen comments ............................................................................................................ 35
4.9.2 Menu description ............................................................................................................ 39
4.10 Using menu—parameter setting..................................................................................... 48
4.10.1 Set flux of blood pump ................................................................................................. 48
4.10.2 Dialysis setting menu .................................................................................................... 49
4.10.3 Advanced setting menu ................................................................................................ 52
4.10.4 Work mode setting menu ............................................................................................. 59
4.10.5 Time setting menu ........................................................................................................ 65
4.10.6 HCO3- setting menu ..................................................................................................... 67
4.10.7 Kt/V setting menu ......................................................................................................... 69
4.10.8 Other setting menu ....................................................................................................... 72
4.10.9 Shut off menu ................................................................................................................ 76
4.10.10 Priming menu ............................................................................................................. 77

4.11 Tone mute function .......................................................................................................... 78
4.12 UF test ............................................................................................................................... 78
5 Treatment ................................................................................................................................ 79
5.1 Preparation work............................................................................................................... 79
5.1.1 Start to run AMI 11 Hemodialysis equipment ............................................................. 79
5.1.1.2 A+B (dry powder) common dialysis mode ................................................................ 80
5.1.2 Self-test of function ......................................................................................................... 82
5.1.3 The supply of the dialysate ............................................................................................ 83
5.1.4 The installation of the injector ...................................................................................... 84
5.1.5 The installation of the blood pipe system ..................................................................... 85
5.1.6 Adjust the injection bracket .......................................................................................... 87
5.1.7 The installation of the adjust- liquor connection ......................................................... 88
5.1.8 The setting of parameter ................................................................................................ 89
5.1.9 Na+ curve graph and UF curve graph .......................................................................... 89
5.1.10.1 The preparation work for prime rinse..................................................................... 90
5.1.10.2 The operation of the prime rinse .............................................................................. 90
5.2 The operation of treatment ............................................................................................... 91
5.2.1 Dialysis treatment ........................................................................................................... 91
5.2.2 Isolated UF treatment..................................................................................................... 94
6 Cleanness ................................................................................................................................ 95
6.1 Introduction .......................................................................................................................... 95
6.2 Exterior cleanness .............................................................................................................. 96
6.3 The basic condition to undergo the process of interior cleanness ................................. 96
6.4 Interior cleanness............................................................................................................... 97
6.4.1 Pipeline connection during the disinfection, hot disinfection and rinse .................... 97
6.4.2 Operation ........................................................................................................................ 99
6.4.2.1 Operation of disinfection ............................................................................................ 99
6.4.2.2 Operation of hot disinfection .................................................................................... 102
6.4.2.3 Operation of rinse ...................................................................................................... 105
7 Alarms show and the disposal of unusual thing ................................................................... 107
7.1 Alarms show ..................................................................................................................... 107
7.2 The alarm of blood loop .................................................................................................. 109
7.2.1 TMP alarm ....................................................................................................................... 109
7.2.2 A.P. alarm .......................................................................................................................110
7.2.3 V.P. alarm .......................................................................................................................110
7.2.4 Blood leakage alarm ...................................................................................................... 111
7.2.5 Blood level alarm ......................................................................................................... 111
7.2.6 Alarm of air bubble .....................................................................................................113
7.2.7 Alarm of heparin ...........................................................................................................113

7.3 The alarm of dialysate loop .............................................................................................114
7.3.1 The alarm of conductivity .............................................................................................114
7.3.2 Alarm of temp. ...............................................................................................................115
7.4 Power failure alarm ..........................................................................................................115
7.5 Battery alarm ....................................................................................................................116
7.6 Warning/notice..................................................................................................................116
7.7 Disposal of unusual thing .................................................................................................117
7.7.1 The disposal principle for the unusual thing of Dialysis Machine ............................117
7.7.2 The disposal of unusual things of Dialysis Machine .................................................118
7.7.2.1 The disposal of warning .............................................................................................118
7.7.2.2 The disposal of unusual things for the main parts.................................................. 120
8 Maintenance and storage ...................................................................................................... 121
9 Instruction for device ............................................................................................................ 123
9.1 Instruction of blood-pressure meter ................................................................................. 123
9.2 Instruction of back-up power supply ............................................................................. 127

This user’s manual is part of the documents of AMI 11 Dialysis Machine, which contains
some necessary information in the operation of AMI 11 Dialysis Machine.
Before use AMI 11, please carefully read through this user’s manual. Please refer to the
actual device for the real appearance of the device.
AMI 11 was designed and manufactured according to the essential requirements of MDD
93/42/EEC and the relevant harmonized standards.
In order to maintain the intended use of AMI 11 Dialysis Machine, the specific consumables or
accessories which are in combination during the therapy; the consumables or accessories
including but not limited to, dialyzer, dialysate (dialysing fluid), extracorporeal blood circuit,
needle and syringe, etc., only the CE-marked consumables or accessories can be used.

List of symbols
Warning:
It warns the operators not to conduct some operation. Otherwise the
device may be damaged, or hazard may be generated toward the
operator or patient.
Note:
It reminds the operator to operate according to the instructions.
Otherwise you may not get the intended result.
Anti-shock protection degree: Type B
Year of Manufacturing
Name and address of the Manufacturer
Handle with care
This way up
Keep dry
Temperature limitation
Consult Instructions For Use

AMI 11 Dialysis Machine User’s Manual (AMI 11)
1 Safety guidelines
1.1 Requirements on the operator

1.1.1 Clinical experience and relative physiology knowledge on Hemodialysis.
1.1.2 Fully understand the contents of this user’s manual of AMI 11.
1.1.3 Have received training on the correct operation and utilization of AMI 11 Dialysis Machine.
1.1.4 Able to distinguish the abnormality of the device.
1.2 Safety notices

1.2.1 The operator should carefully read through the user’s manual before the operation of the AMI 11
Dialysis Machine.
1.2.2 The operator should verify the parameter that he or she inputs, that’s to say, the operator should
check whether the input parameter value is correct or not. If there is discrepancy between the
optimal parameter value and the displayed parameter value, the setting value should be
adjusted before running the device.
1.2.3 Make sure the power supply system (circuit, voltage and cable) meets the electricity load
requirement of the device.
1.2.4 AMI 11 Dialysis Machine is a CategoryⅠand Type b device, please plug the power cable into a
three core socket with grounding wire, making sure the grounding is appropriate.
1.2.5 During the dialysis period, if the protective system alarms, the operator should find out the alarm
reason timely and solve the abnormality quickly before the dialysis continues. In case of alarms
that fail to resume normal in short time, or serious abnormality, the dialysis treatment should be
terminated.
1.2.6 The requirements for consumables or accessories：only CE-marked devices including but not
limited to dialyzers, extracorporeal blood circuit, dialysing fluid, needles and syringes can be
used.
1.3 On dialysis treatment, this machine only limited to one patient use. When shifting patient to receive
the treatment, the machine should be disinfected in order to avoid cross infection.
1.4 Contradiction: uncontrollable coagulation abnormality.
1.5 Only the manufacture or those personnel authorized by the manufacturer can assemble, test or
repair the hemodialysis machine.

1.6 In case of malfunctions, you can try the normal troubleshooting methods, In case of failure, please
contact the company. Non-professional personnel are not allowed to disassemble the device.
1.7 If use the recommended control device, dialyzer, fistula needle and blood line, we can supply the
opinion for the reprocessing times.

2 Brief introductions
2.1 Intended Use
AMI 11 Dialysis Machine is used for Hemodialysis on patients with acute or chronic kidney failure. AMI
11 Dialysis Machine can be used in various medical centers and for clinical use. When AMI 11 is
conducting HD treatment, it runs and monitors the dialysate circulation as well as the extracorporeal
blood circulation.
2.2 Indications and contraindications
Indications:
(1) Acute renal failure
(2) Chronic renal failure
Contraindications:
In recent years, with the improvement of dialysis techniques, hemodialysis is no longer an
absolute contraindication.
The following conditions are relative contraindications:

1. Advanced malignancy (except multiple myeloma)
2. Alzheimer’s disease
3. Multi-infarct dementia
4. Hepatorenal syndrome
5. Advanced liver cirrhosis with encephalopathy
6. Hypotension unresponsive to pressors
7. Terminal illness
8. Organic brain syndrome.
The explanations about other situations

The following situations were not studied or investigated, health professions can
determine with their experiences and professional knowledge:
(1) Acute toxicosis due to drug or poison
(2) Other Diseases

a. severe water, electrolyte and acid-base balance disorders, using general
therapy is difficult to take effect;
b. hepatic coma and hepatorenal syndrome;
c. hepatic cirrhosis and refractory ascites;
d. hyperbilirubinemia;
e. hyperuricemia.
2.3 Introductions on the HD device
2.3.1 All the operation menu and running status of AMI 11 Dialysis Machine is displayed on the color
LCD screen.
2.3.2 AMI 11 Dialysis Machine uses hydrogen carbonate and acetate for HD treatment.
2.3.3 AMI 11 Dialysis Machine With single needle dialysis function.
2.3.4 AMI 11 Dialysis Machine is connected to the RO water container, and can be moved to an
environment that is far away from the water supply for emergency.
2.3.5 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.
2.3.6 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.
2.3.7 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’s
demand.
＋
2.3.8 Based on the requirement of treatment, the concentration of Na can be adjusted in the range of
136mmol/L～145 mmol/L.
2.3.9 During the HD treatment, by using the flow pump, the concentration of the electrolyte in the
dialysate can be increased to meet the requirement of treatment.
2.3.10 AMI 11 Dialysis Machine can conduct pure UF (ISO UF) and single needle treatment.
2.3.11 AMI 11 Dialysis Machine can conduct rinse, hotrinse, and disinfection procedures to complete
automatic cleaning and disinfection. A statement that the test procedure by which the effectiveness
of disinfection or sterilization has been verified is available on request.
2.3.12 The flux of dialysate can be adjusted within the range of 300 ml/min～700 ml/min.
2.3.13 AMI 11 Dialysis Machine is equipped with a safety monitor system that ensures the safety of
patients. Extracorporeal blood-losing protection system meets with EN60601-2-16 < Medical
electronic equipment — Part 2-16: Particular requirements for the safety of haemodialysis,
haemodiafiltration and haemofiltration equipment >”.
2.3.14 AMI 11 Dialysis Machine device complies with EN 60601-2-16: 1998/ AC 1999 < Particular
requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment >
standard.
2.4 Main technical specifications
Dimension: Height: About 149.4 cm (Fluid stand is not included)
Width: About 55.5 cm
Length: About 35.9 cm (Foot is not included)
Area: About （56.3×62.5） cm2
Weight: About 90 kg
Electric safety
Electric shock resistance type: Category I
Electric shock protection degree: Type B Symbol:
Liquid incursion protection: Anti-dripping Symbol: IPX1
Work system: Interim loading continuous running
Power supply
Line voltage: AC220V, Frequency 50/60Hz
Input power: 1700VA
Fuse: 2×10A（Ф6×30）
Main switch: C65N 32A AC250V
Working condition
Flow-in water pressure: 0.12 MPa～0.6 MPa (Standard)
0 MPa～0.6 MPa (Options)
Flow-in water temperature: 5°C～30°C
Working environment: Temperature 10°C～30°C, with relative humidity not greater than
70%
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 hotrinse the device before the
device resumes working.

Storage temperature: 5°C～40°C (without using anti-freeze)
-10°C～40°C (without using anti-freeze)
Stability: 10°C
Restrain hearable alarm: The silent time of alarm is 2 minutes.
New alarm can activate mute alarm
Working procedure
Function test: Automatic test on the safety system after powering on.
Rinse the system lines: In “Rinse” status, the device automatically rinses the system lines.
HD: Hemodialysis with hydrogen carbonate and acetate
Sequential UF: UF/Pure UF (ISO UF) without flow of dialysate
Cleaning procedure: Including disinfection, hot-rinse, rinse three modes.
Disinfect mode is divided into “Citric acid” and “Per-acetic acid”.
Hot-rinse mode is divided into “Heat + Citric acid” and “Heat”.
Disinfection: period: See Appendix A
temperature: See Appendix A
Hot Disinfection: period: See Appendix A
temperature: See Appendix A
Rinse: period: About 10 minutes
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 300 ～
700ml/min, temperature is 37°C)
TMP: Display range: -100 mmHg～+600 mmHg
Precision: ±20 mmHg
Width of warning window: Adjustable in the display range
UF: ISO UF flow rate: 0～4000ml/h
HD flow rate 0～3600ml/h
UF preset range: 0～14400 ml
UF precision: ±30 ml/h

Concentration of dialysate Display range: 12.3 mS/cm～15.8 mS/cm
(conductivity) Resolving rate: 0.1 mS/cm
Precision: ±0.1 mS/cm
Width of warning window: 0.8mS/cm～1.6mS/cm
Flow pump: Injection rate of flow pump: 0.1ml/h～10 ml/h
Injection period of flow pump: 0～9:59
Hydrogen carbonate: Standard setting: 1:1.225:32.775
1:1.830:34.000
1:1.830:34.000
1:2.100:34.000
Sodium concentration between the second setting and the third setting is different.
Na+ adjustment range: 136 mmol/L～145 mmol/L
Temperature:
Dialyses temperature, rinse and chemical disinfection temperature:
Adjustment range: Dialysate 35.0°C～39.0°C
Clean 37°C
Temperature alarm: Dialysis Maximum preset upper limit is 40°C
Minimum preset lower limit is 33.5°C
Hot-rinse temperature: Rated temperature: 80°C
℃
During hotrinse, once the temperature reaches 80 , the timer is
triggered. In case of malfunctions, the heater will be closed at
90°C.
Flow rate: Flow rate of dialysate: 300～700ml/min

+10%
Precision: -5%
Chemical disinfection: See Appendix
External blood circulation and safety system
Blood pump: Rang of flow rate: 20ml/min～460 ml/min（ID Ф 7 mm）
20 ml/min～620 ml/min（ID Ф 8 mm）
Resolving rate: 1 ml/min
Precision: ± 10 ％（ Flow-in pressure: -26kPa ～ +15kPa,
flow-out pressure is less than 100kPa)

Pump tube diameter: Ф 7 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
Alarm: Adjustable within the range of -300 mmHg～+400 mmHg
Venous pressure: Display range: -50 mmHg～+300 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
Precision: Pressure is less than 100KPa, ±5％
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 0～72 dB
The cycle of sound alarm is one per second; the intermittent silence
is 0.5 second.
Tone mute time for bridging: 50 seconds.
Blood way lines and dialysate are universal with Fresenius and Toray.
Optional device
Backup power supply Lead acid battery (maintenance-free)
24V（2×12V）/ 7Ah
Blood-pressure meter Display blood pressure and pulse value by digits

3 Definition and terms
Please find below some explanation on the special terms that are used in this manual.
Extracorporeal circulation: Blood circulation conducted outside the human body.
Air trap: Air device installed in the blood line system to separate the gas that is
irresolvable in the blood, including blood level inspector and air bubble
inspector.
Bypass: Bypass the dialysate from the dialyzer.
Conductivity: The electricity conductivity of the dialysate.
Venous line clamp: The device that automatically clamps the blood line system.
Blood measurement line: Line that connects the blood way system and the pressure monitor device.
Rotation pin: Pump head of the blood pump and spare pump, which is used to press
pump tube by rolling.
A+B: A concentration plus B concentration.
A+B (dry powder): A concentration plus B powder.
Bi-cartridge nip: The device which used to load Bi-cartridge.

4 Structure and function of HD device
4.1 Overall structure of HD device
HD Device ——Appearance

HD Device ——Front view
Illustration:
1. LCD display
2. Blood pressure measurement
display screen (optional device,
refer to 9.1)
3. Switch of spare pump
4. Spare pump
Relieving
Charging
Start
SBP
mmHg
kP a
ON/OFF
Start
5. The adaptor of venous pressure
ON/ OFF ON/ OFF
DBP Pulse
6. Blood level adjustment button of

venous pot
P1
Raise the height of blood level
Venous P1
of venous pot
Lower the height of blood
level of venous pot
7. Air bubble inspector (Optical
A B inspection)
8. Switch of venous line clamp
9. Venous line clamp
10. A adapter group (red / white)
11. Indicator
Red blinks—Alarm
Yellow on—Ready
Green on—Running
12. Fluid stand
13. Power supply indicator
14. Switch of power supply
15. Switch of blood pump
16. Blood pump
17. The adapter of arterial pressure
18. Arterial pot plank
19. Heparin pump
20. B adapter group (blue)
21. Filter

HD Device ——Rear view

Illustration:
1. Ventilation fan
2. Power box
3. Power switch
4. Sampling port 1 of UF fluid
5. Disinfection solution connector
6. Sampling port 2 of UF fluid
7. Ejection water port
8. Alarm beeper
9. Fuse (2X10A)
10. Power cable
11. Mark symbol
symbol (Notice: refer to the
IPX1
accompanied documents)
symbol (Anti-shock protection
degree: Type B)
IP × 1 （ inflow liquid protection
enti-drip）
12. Supply pipe connector
13. Dialyzer return connector
14. gas port
15. Inlet port of RO water

HD Device ——Left view

Illustration:
1. Dry powder frame
2. Cover
3. Blood pressure measurement
port

HD Device ——right view

Illustration:
1. Clamp of dialyzer
2. Reflux tube of dialysate (red
adapter)
3. Supply tube of dialysate (blue
adapter)Filtration adapter
4. Bobber observation device
5. Filter

4.2 Components
4.2.1 Structure of blood pump/spare pump
Illustration:
1. Pump cover
2. Rotation pin
3. Pump case
4. Clamp
5. Pump tube fixation
slot
Pull out the spanner of the rotation pin, rotate the spanner until the handle is vertical against the
rotation pin fixation slot, then the rotation pin is able to be released from the pump case
Illustration:
1. Rotation post (one on each side)
2. Guiding post
3. Spanner
4. Adjustment screw (one on each side)
5. Rotation pin fixation slot
4.2.2 Structure of syringe stand
Illustration:
1 2 3 4 5
1. Stopper
2. Stopper adjustment button
3. Fixation slot
4. Syringe clamp
5. Pump holder

4.3 Introduction on extracorporeal blood circulation
Introduction on extracorporeal blood circulation:
Connect the artery and vein of the patients with the blood pump, dialyzer and monitoring device, to
establish a close circuit of external circulation.
During the dialysis, the heparin pump injects heparin into the blood way on a regular basis to prevent
the blood from coagulation. The heparin flow rate can be adjusted according to the treatment
requirement. The range of heparin flow rate is 0.1 ml/h～10 ml/h.
Note:
Using syringe of heparin pump to suck heparin, the intending volume
injected should be 1.5ml more which to avoid water empty alarm when
machine inspect heparin volume in injector is about 1ml.
The patient blood was led out of the body by the blood pump and enters the venous pot after going
through the dialyzer. In the venous pot, the venous pressure is measured and strictly monitored within the
preset range. The venous pot is located in the ultrasonic fluid level inspector to prevent the introduction of
air. Once the fluid level is lowered and bubble blood appears in the venous pot, the blood alarm is
triggered. The blood pump stops immediately, the venous line clamp automatically clamps the venous
blood way to block blood reflux, alarm with light and sound begins, and the UF ends.
After going through the venous pot, the blood flows through the air bubble inspector, which detects the
existence of air bubble in the blood circuit. Once the air bubble is found, the alarm with light and sound is
triggered. The blood pump and the UF pump stop immediately, the venous line clamp automatically clap
the blood way to prevent blood reflux.
Eventually, the blood is conveyed back into the patient body.

Extracorporeal blood circulation illustration:
B2
B1 B3 B4
Artery End
B11
B14 B12
Connect
B16 B10 To
B6
B15 B13 Dialysate
B7 Circut
B8
Vein End B9
Illustration:
B1. Arterial pressure inspector

B2. Blood pump
B3. Heparin pump syringe
B4. P1 inspector
B5. Dialyzer
B6. Ultrasonic blood level inspector
B7. Venous pot
B8. Venous line clamp
B9. Air bubble inspector
B10. Ventilation valve
B11. Venous pressure inspector
B12. Air bleed pump
B13. Ventilation pump
B14. Electromagnetic valve
B15. Electromagnetic valve
B16. Ventilation valve

4.4 Introduction on the water way system
The following two RO water supply methods are available for selection:
1. Supply by the RO water tube, the adapter (W1) connects to the RO water tube.
2. Supply by the container, the RO water container supplies the fluid, the adapter（W1） connects to
the RO water container.
The RO water enters the water way through the adapter W1, and it’s heated in the heater system (W5)
after getting through W2 ,W3 and W4, meanwhile, air will be removed in W5 by the air-removing device
(W6).
The heat exchanger (W3) is to transfer the heat from the used dialysate that runs out of the balance
system to the RO water.
After the air is removed, the RO water gets to the confecting system (W7), and the concentrate is
pumped up into the confecting system by the ceramic pump at the same time, and then they get mixed
into dialysate. The dialysate is driven by the pre-dialysis pump (W8), and runs through the mix
temperature sensor (W9) and the mix conductivity sensor (W10) into the balance system (W11), then it
runs through another temperature sensor (W12) and conductivity sensor (W13), if the temperature or the
conductivity doesn’t meet the preset values, the pre-dialysis valve (W14) and the post-dialysis valve
(W22) will be closed and the bypass valve (W23) will be opened to get the unqualified dialysate around
the dialyzer (W18). If the temperature and the conductivity meet the preset values, the bypass valve
(W23) will be closed, and the pre-dialysis valve (W14) and the post-dialysis valve (W22) will be opened
to lead the dialysate into the dialyzer.
Note ：When bicart cartridge is loaded, tube B should connect back to the connector Block of
Concentrate B.
The used dialysate that come out from the dialyzer runs through a pressure sensor (W21), the
pressure measured here can be regarded as the value for TMP calculation.
The used dialysate runs through the air-removing device (W24) again in order to ensure the volume of
the fresh dialysate is exactly the same as the used dialysate that is replaced all along. Then it is driven
by the post-dialysis pump (W28), and runs through the balance system (W11), the heat exchanger (W3)
and the blood leakage inspector (W35). The blood leakage inspector is to monitor if there is blood
infiltrating the dialysate circuit due to the damage of dialysis membrane. After that, the used dialysate
runs through evacuation valve (W36) and gets out of the water way from outlet of evacuation (W37).
The UF pump (W34) draws out the dialysate from the fluid infusion system at the preset rate. As the
system is airtight, the ultrafiltrate can be drawn out at the same volume from the blood through the
dialyzer.

W27
DFU.017
W31
W26 W25
W32
W24
W30
W42 W29
W34
动
脉
端
W40
Waterway sketch map
W50
W22 W21
T026
W20 W19 W51
connect
W41
to blood
W28
W38 W18 circuit
W23
W9 W12 W14
W8 W15 W17
W10 W13 W16
W7
W11 W52
W53 W54 W55
W43
静
脉
端
W39
W33
W44 W46
W35 W36
W5 W6
W45 W47
W37
Page 27 of 145
W3
W4
W2 W1
Rev.01
RO water container
01-March-2012
Illustration:
W1. Inlet of RO water W28. Post-dialysis pump
W2. Pressure decreasing valve W29. Inlet of UF valve
W3. Heat exchanger W30. Disinfection valve
W4. Septum pump W31. Disinfectant back valve
W5. Heater system W32. Disinfectant interface
W6. Recycle air-removing device W33. UF sampling quick connector
W7. Confecting system W34. UF pump
W8. Pre-dialysis pump W35. Blood leakage inspector
W9. Mix temperature sensor W36. Evacuation valve
W10. Mix conductivity sensor W37. outlet of evacuation
W11. Balance system W38. ceramic pump B
W12. Temperature sensor W39. ceramic pump A
W13. Conductivity sensor W40. Air-removing device of concentrate B
W14. Pre-dialysis valve W41. Dry powder frame
W15. Filter W42. Concentrate B filter
W16. Bobber observer W43. Concentrate A filter
W17. Fast adapter sleeve of dialyzer inlet (blue) W44. Concentrate A adapter
W18. Dialyzer W45. Concentrate B adapter
W19. Fast adapter sleeve of dialyzer inlet (red) W46. Connector Block of Concentrate A
W20. Filter W47. Connector Block of Concentrate B
W21. Pressure sensor W50. Blood pump
W22. Post-dialysis valve W51. Heparin pump
W23. Bypass valve W52. Venous pressure
W24. Fluid air-removing device W53. Venous pot with ultrasonic sensor
W25. Fluid air-removing valve W54. Venous line clamp
W26. Fluid air-removing pump W55. Air bubble inspector
W27. Gas port

4.5 Introduction on hydrogen carbonate and acetate dialysis
4.5.1 Connection of concentrate tube
Two types of concentrates used in hydrogen carbonate dialysis:

——Acidic concentrate (concentrate A)
——Hydrogen carbonates concentrate (concentrate B)
The concentrate is sucked by two pumps, and is conveyed to the HD device to mix with the RO water.
The suction tube of concentrate is connected to the container accordingly.
To minimize misusing of concentration, concentration container should have special mark.
To avoid the misconnection with container, sucking pump should also have special mark.
Warning:
You must use the container with specific mark and matched suction
tube, to avoid wrong connection.
Please refer to the instructions for use of the Dialysate fluid.
The mixing process is based on volume and proportion. That is, the concentrate pump mix certain
volume of concentrate into the water of fixed volume.
Only by using the concentrate matching the mixing system, you can get a correct ion concentration in
the dialysate.
By measurement on the conductivity and the bypass function, the system can prevent the dialysate
with wrong concentration from entering the dialyzer.
In case of existence of wrong components in the dialysate, the conductivity will exceed the alarm range
and triggers the alarm. The HD device then opens the bypass, accompanied with light and sound alarm.
Warning:
The hydrogen carbonate concentrate and acetate concentrate cannot
be stored again once opened.
Warning:
Please make sure the container has sufficient hydrogen carbonate
concentrate and acetate concentrate to complete the treatment.

Tube connections is as below
① Tube connection of A+B mode—Front view
Place the concentrate A adapter (red) of the

concentrate A suction tube into the concentrate
A container.
Place the concentrate B adapter (blue) of the

concentrate B suction tube into the concentrate
B container.
Left side view of A+B (dry powder) mode

② Tube connection of A+B (dry powder) mode—Front view
Put B suction tube to the B adapter

seat and get it locked but circumgy
A B rating as the right figure shows.
Left side view of A+B (dry powder) mode
Put B powder cartridge corresponding to A

solution onto Bi- cartridge frame.

4.5.2 Supply method of the RO water
Only the RO water can be used when confecting the dialysate.

The requirement of the RO water's quality meets with the standard ISO 13959:2009.
4.5.2.1 RO water tube supply
Tube connection—Rear view
Connect the tube to the adapter.
4.5.2.2 Container supply (selective device)
Tube connection—Rear view
Connect the tube with the dialysate container.

4.6 The installation of Bi-cartridge
Install Bi-cartridge according to the following fixing sequence
First draw the handle according to the arrow

direction on the Dry powder frame, then raise it,
open the Dry powder frame, as following figure
show.
Handle
Open dry powder frame as left figure, then

put the bottom of bi-cartridge on bottom of
Dry powder frame. Then press the top down,
fix bi-cartridge on the dry powder frame.
When you press it down, increase your
strength, to make sure the bi-cartridge and
Dry powder frame sealed better.

Finished the installation of Bi-cartridge , as

left figure shows
4.7 Description of combination for Na+ curve graph and UF curve graph
AMI 11 HD device possesses the function of combining Na+ curve graph with UF curve graph.
Na+ curve graph: 0 ～ 7;
UF curve graph: 0 ～ 7.
The below diagram will show the possible combination of Na+ curve graph and UF curve graph:
+
Na curve graph
0 1 2 3 4 5 6 7
UF
curve
1
graph
2

4.8 Introduction on the cleaning procedures
Cleaning procedures
The cleaning procedures include three items, which are disinfection, hot-rinse and rinse. Please refer to
6.4.2 for the detailed process of each item.
Decalcification
Detailed in the appendix (A) attached to this manual.
4.9 Menu description
4.9.1 Screen comments
Screen chart (i.e.: screen for dialysis setting menu)
2 3 4 5
Prime
Stopped
Dialysis Setting KEY
Dialysis Time 4 : 00 Heparin Time 3 : 30 0 1

2 3 6
1 UF Goal 0000 ml Heparin Flux 03.0 ml/h
4 5
UF Max 0000 ml/h Base Na+ 140 mmol/l 6 7
8 9
UF Volume 0000 ml Na+ Max 150 mmol/l
<- ->
UF Curve 0 Na+ Curve 0
Return OK
8 7
Screen description:
1. Menu area
2. Current mode
3. Text area (display the text info.)
4. Mute button
5. Battery area (display battery capacity)
6. Keyboard (input data)
7. Confirm key (save the setting content)

8. Return key (exit the menu)
The color description for the data in menu area:
Background Font Fig. value

White Black Can’t input
Black White Can input

Screen display (i.e.: dialysis menu)
2 3 4 5
Prime Signal error alarm
Stopped Lower Temp alarm
TMP. A.P. V.P. Cond. Battery Blood Leak Blood Level Air Bubble Heparin Clogging Temp.
6
7 Conductivity Temperature UF Pump 9

00.0 mS/cm 34.0 ℃
600 400 300
1 500 300 250
15.5
15
Na+ Heparin
400 200 200
14.5
8 Adjust
300 100 150 140 mmol/l
14 Bypass
200 0 100
Heparin Time
13.5
100 -100 50
13
3:30 Blood Pump
0 -200 0
12.5 Heparin Flux
-100 -300 -50
mmHg mmHg mmHg mS/cm 03.0 ml/h Previous Page
01.01
10 Prime Treatment Disinfect Setting MON 15:03 11

Stopped Lower Temp alarm
UF Goal
UF Pump
0000 ml 12
UF Rate TMP Ven Art Heparin
0010 ml/h 0097 mmHg -002 mmHg 0000 mmHg

Bypass
UF Volume Time left Spare Pump
0000 ml 4:00 0200 ml/min Spare Pump

Blood Pump
Blood Pump
Next Page
0220 ml/min
01.01
Prime Treatment Disinfect Setting MON 15:03
Screen description:
1. Menu area
2. Current mode
3. Text area (display text information)
4. Mute button
5.Battery area (display battery capacity)
6. Alarm indicator light

、
7. ▲ ▼arrow key(modify data)
8. Calibration button for conductivity rate
9. Running key (blood pump, heparin pump, UF pump, spare pump and bypass)
10. Function key (run key, bridging key, return key, setting key)
11. Time area
12. Curve button (simultaneously display Na+ curve graph and UF curve graph)
Display for the color of running key:
It displays blue background and black font in stop status
It displays blue background and black font in start status
Note:
The operator's position: 10 ~ 20cm in front of LCD.
Note:
When main power supply and internal power supply are cut down, the machine cannot
record the log; only the either of them is cut down, machine can record the log.

4.9.2 Menu description
Power supply switch on screen
Display logo and product model on the screen.
Select self-test mode
Select Therapy This menu display the information of therapy.

1:Place the suction tubes of liquid A&B into concentrate container respectively prior to
Use function key to select hemodialysis,
running haemodialysis.
hemoperfusion, skip.
2:Press "Skip" button if no need self-test.
3:Please call service engineer if self-test failed.
Hemodialysis Hemoperfusion Skip
Self-test menu
Lower Temp alarm
Self-test Lower Conductivity alarm Self test.
Blood Level Normal Spare Pump Normal
Test Gear
pump Test In-Pro.
The below color marks the status for every
test:
Test Cond.
Air Bubble Normal Heparin Pump Normal Test In-Pro.
system
test status color
V.P. Normal
Water Work
preparation
Test Temp.
Test In-pro. system Test In-Pro. test in-process yellow
normal green
A.P. Normal Test Balance
Test in-pro
valve failed red
TMP Normal Test UF
pump Test in-pro The info.of current testing displays in text area.
Blood Pump Normal Test A/B
Test in-pro Screen will enter into priming menu
pump
Temp. 23.0 ℃ Cond. 01.0 mS/cm Exit

automatically when self-test finished.
If test failed, press EXIT key and screen will
enter Priming menu.

Prime rinse menu

Stopped Lower Temp alarm It displays various parameters for dialysis
treatment.
Conductivity Temperature UF Pump There are two display interface, press
00.0 mS/cm 34.0 ℃
600 400 300
15.5
500 300 250
15 Heparin
“Previous Page” to shift the interface.
400 200 200 Na+
Adjust
300 100 150
14.5
140 mmol/l Use ▲or▼ to modify the alarm range of
14 Bypass
200 0 100
Heparin Time
100 -100 50
13.5 TMP/AP/VP/Cond..
13
3:30 Blood Pump
0 -200 0
12.5 Heparin Flux
Use “Adjust” key to adjust cond of dialysate to
-100 -300 -50
03.0 ml/h comply with Na+ concentration set.
mmHg mmHg mmHg mS/cm Previous Page
01.01

Stopped Lower Temp alarm Use ▲or▼ to modify the flux of blood pump
and UF presetting volume.

UF Goal
UF Pump Use function key to select treatment,
0000 ml
UF Rate TMP Ven Art Heparin disinfection and setting menu.
0010 ml/h 0097 mmHg -002 mmHg 0000 mmHg This interface can display commutation
Bypass
volume of blood pump.
Blood Pump
Blood Pump
Next Page
0220 ml/min
01.01
Dialysis menu
Dialysis Signal error alarm
Stopped Lower Temp alarm It display the current status of HD device
during dialysis.
Conductivity Temperature UF Pump There are two display interface, press
00.0 mS/cm 34.0 ℃
600 400 300
15.5
500 300 250
15 Heparin “Previous Page” to shift the interface.
400 200 200 Na+
Adjust
300 100 150
14.5
140 mmol/l Use ▲or▼ to modify the alarm range of
14 Bypass
200 0 100
Heparin Time
100 -100 50
13.5 TMP/AP/VP/Cond..
13
3:30 Blood Pump
0 -200 0
12.5 Heparin Flux
-100 -300 -50
01.01
Run Bridging Return Setting MON 15:03


Stopped Lower Temp alarm Use ▲or▼ to modify the flux of blood pump
and UF presetting volume.
UF Goal
UF Pump
0000 ml
Press“ ” to setup the function of HCO3
0010 ml/h 0097 mmHg -002 mmHg 0000 mmHg curve, this interface display each parameter the
Bypass
current treatment.
Blood Pump
This interface can display commutation
Blood Pump
Next Page
0220 ml/min volume of blood pump.
01.01
Curve display menu

Prime
Stopped
Press curve key “ ” on dialysis menu and
UF profile Na+ profile Kt/V HCO3-
Time Left 4:00
UF profile enter into curve display menu of “UF profile”,
UF profile means use different UF rate in different phase
UF Rate 2000 ml/h
in dialysis.The area of UF profile means UF volume.

UF Goal 0000 ml “Na+ profile”, “Kt/V” and “HCO3-“ .
2000
UF rate(ml/h) UF Volume 0000 ml Press the key of “UF profile” and it will display
V.P. 0003 mmHg
menu of UF curve.
1500
TMP -100 mmHg
1000
Na+ 140 mmol/l If dialysia treatment time is more than 5 hours,
500
Cond. 00.0 mS/cm
machine will not go into curve display manual
Temp. 00.0 ℃
0
through curve key-press of menu.
0 1 2 3 4 5 6
Time(h)
Exit
Prime
Stopped Press the key of “Na+ profile” and it will display
4:00
menu of the Na+ curve.
Time Left
Na+ profile
Na+ profile means use different sodium concentration automatically
UF Rate 2000 ml/h
in different phase in dialysis.

UF Goal 0000 ml
Na+ concentration(mmol/l) UF Volume 0000 ml

160
V.P. 0003 mmHg
150
TMP -100 mmHg
140
Na+ 140 mmol/l
Cond. 00.0 mS/cm

130
Temp. 00.0 ℃
120
0 1 2 3 4 5 6
Time(h)
Exit

Prime
Stopped Press the key of “Kt/V” and it will display menu
Time Left 4:00
If the result after dialysis is >1.2, it means dialysis adequacy.
of the Kt/V curve.
UF Rate 2000 ml/h
Kt/V
3.0 UF Goal 0000 ml
0.0
2.5
UF Volume 0000 ml
V.P. 0003 mmHg

2.0
TMP -100 mmHg

1.5
Na+ 140 mmol/l
1.0
Cond. 00.0 mS/cm
00.0 ℃
0.5
Temp.
0.0
0 1 2 3 4 5 6
Time(h)
Exit
Prime
Stopped Press the key of “HCO3-“ and it will display
HCO3- profile
Time Left 4:00
menu of HCO3- curve.
UF Rate 2000 ml/h
HCO3- standard value:35mmol/l.

HCO3- profile means HCO3- concentration and relative time setted
as required dialysis.
UF Goal 0000 ml
HCO3-(mmol/l) standard value(mmol/l): 35

UF Volume 0000 ml
42
40
V.P. 0003 mmHg
TMP -100 mmHg
35 Na+ 140 mmol/l
Cond. 00.0 mS/cm
30
Temp. 00.0 ℃
28
0 1 2 3 4 5 6
Time(h)
Exit

Set the selective menu
Prime
Stopped The below setting can be selected in this
Setting Select KEY menu:
——Dialysis Setting
0 1
Dialysis Setting Advanced Setting
2 3 ——Work Mode
Work Mode Time Setting
4 5 ——HCO3-
HCO3- Kt/V 6 7 ——Kt/V
Other Setting Shut Off 8 9 ——Other Settings
Common Setting <- -> ——Advanced Setting

Blood Pump 210 ml/min BP Volume 000.0 L Return OK ——Time Setting
——Shut Off
It can modify the flux of blood pump on the
menu.
Dialysis setting menu
Prime
Stopped The below parameters can be set in this
dialysis setting menu:
4 : 00 3 : 30 0 1
Dialysis Time Heparin Time
——Set dialysis time, heparin time and flux
2 3 ——Set UF flux and UF total volume
UF Goal 0000 ml Heparin Flux 03.0 ml/h
4 5 ——Set Na+ basic value and Max.value
UF Max 0000 ml/h Base Na+ 140 mmol/l 6 7 ——Set UF curve graph
8 9 ——Set Na+ Conc. Curve graph
<- -> Display of fig. color:

Return OK Black background &white font: can input;
White background &black font: has been set.
Advanced setting menu
Prime
Stopped Set the alarm value of V.P., A.P., TMP and
Advanced Setting KEY
Cond..
Adv. set Cond. save Temp. save Reserve Tube of Hep
0 1
Modify the upper & lower value of temp. alarm.
V.P. Span 200 mmHg Upper Temp. 38.5 ℃
2 3 Pipe diameter setting of blood pump and spare
A.P. Span 200 mmHg Lower Temp 34.5 ℃ 4 5 pump, dialysate flow and alarm volume adjusting
Blood Pump 8mm 6 7 are also included in this menu.
TMP. Span 400 mmHg
Pipe dia. 7mm
8 9 This menu can also display the data and
Spare Pump 8mm
Cond. Span 1.0 mS/cm
Pipe dia.
7mm <- -> profile records of conductivity and temperature.
Dialysis Flux 500 ml/min Alarm Volume
Return OK

Working mode setting menu

Prime
Stopped Treatment mode can be setted as following
Work Mode Setting
Work Mode ISO UF Set Conn. Draw Reserved Reserved Reserved Reserved
during in the working mode menu
A : B : H2O Worke Mode Disinfect Mode Hot Dis. Mode ——Work mode;
1:1.225:32.775 HD
1:1.830:34.000 ISO UF
Citric acid Heat+Citric acid ——ISO UF setting;
Peracetic acid Heat
1:1.830:34.000
1:2.100:34.000 ——Conn. Draw.
Acetate
Na + ：A + B = ?
105 + 35 = 140
Blood Mode
A+B Mode (Needle)
A+B Double
A+B （Dry Powder） Single Return OK
Time setting menu

Prime
Stopped Time setting menu.
Time Setting KEY
Setting date, time, and week in the setting time
Time Set Cond comp Temp comp Other Comp Result
0 1
menu.
Year Month Date
2 3
20 08 01 01 This menu can also display the accumulative
4 5
Hour Minute Day running time of this machine.
6 7
00 03 7
8 9
Accunulative Running Time
<- ->
0000042 Hour 16 minute
Return OK
Prime
Stopped Cond. Compare menu.
Time Setting KEY
The scope of both the monitor upper limit and
0 1
～ 2mS/cm. The
16.5 16.5 16.5 16.0

the monitor lower limit is 0.5
Pre.Cond. Mix Cond.
2 3
16.0
20.6
16.0 16.0
00.1
15.0
default value in the systerm is 1.0mS/cm.
15.5 15.5 15.5 14.0
4 5
15.0 Post Cond. 15.0 15.0 Cond. A 13.0
According to the operator’s setting, system will
14.5 00.1 14.5 14.5 00.1 12.0
14.0 14.0 14.0 11.0

6 7 automatically process the pre-dialysis and
Up Limit (A:B:H2O)
13.5
01.0
13.5 13.5
1:1.225:32.775
10.0
8 9 post-dialysis conuctivity compare. If compare
13.0 13.0 13.0 1:1.260:32.740 9.0
12.5
Low Limit
12.5 12.5 1:1.830:34.000
1:2.100:34.000
8.0 <- -> fails for 3 times continousely, it will display alarm
12.0 12.0 12.0 7.0
01.0 Na + A + B= ?
mS/cm
11.5
mS/cm
11.5 11.5
mS/cm
105 + 35 = 140
mS/cm
6.0
Return OK message:”Cond of pre-dia and post-dia different,
please check.” If one of the 3 times compares
success, it won’t alarm and won’t choose
bypass. The compare will process during the
dialysis process.circularly.
The process information of this compare will
display in “Comp. Result” menu.

Prime
Stopped Temp comp. menu.
Time Setting KEY
System will process pre-dialysis temparature
0 1
41.0 41.0 41.0 41.0
and post-dialysis temp.compare automatically,
Pre Temp Mix Temp
2 3
40.0
16.4
40.0 40.0
16.9
40.0
and display the information of pre-dialysis temp.
39.0 39.0 39.0 39.0
4 5
38.0 Post Temp 38.0 38.0 Temp. A 38.0
post-dialysis temp., temp setting,mix. Temp. and
37.0 16.7 37.0 37.0 16.8 37.0
36.0 36.0 36.0 36.0

6 7 temp of solution A.
Temp. Set
35.0 35.0 35.0 35.0
8 9
34.0 36.0 34.0 34.0 34.0
33.0 33.0 33.0 33.0 <- ->

32.0 32.0 32.0 32.0
31.0 31.0 31.0 31.0

℃ ℃ ℃ ℃ Return OK
Prime
Stopped Other menu.
Time Setting KEY
This menu displays the temperature of heating
0 1
chamber, goal of heating chamber, average of
Heat Ch. Temp 023.0 ℃ Pump A Data
ml/100Round
01198 ml
2 3 outlet Temp., goal Cond. of A , blood leakage
021.9 ℃
Goal of Pump B Data
heat Ch. ml/100Round
01192 ml 4 5 feedback, communication ok, Pump A data,
004.0 ℃
Dia. Fluid
Average of
Outlet Temp. (ml/9 Cavity) 00709 ml 6 7 pump B data, dialysis fluid feedback, UF Pump
UF pump
Goal Cond. of A
(mS/cm) 000.0 (3.5ms/Round) 00000 8 9 feedback, UF P Reference and communication
Blood.leak 00035 UF P. Ref 22634300 <- -> failed.
Comm OK 003066 Comm Faild 000013
Return OK
Prime
Stopped Comp. Result menu
Time Setting KEY
This menu displays process information during
0 1
the compare in “cond. Compare menu”
Pre & Post Cond. Forbid
Check Phase 000 comp. bypass or not OK
2 3 “Check phase” means whih times of compare
Comp. time 000 S
4 5
it is processing;
Conductivity
Dif. time
000 S
6 7 “Comp. Time” means how long it will take for
P-cond.Check
Dif. times
000 8 9 the compare;
Comp. Result
of Pre.& Post
Not Compare
<- -> ”Conductivity Dif. Time” means the time
Waterway Normal
Bypass Status
Return OK beyond the error scope in this compare result;
”P-cond.Check Dif. Times: means the times
that compare result beyond the error scope
during process of the compare;
”Comp. Result of Pre.&Post.” Means the result

of this compare;
”Waterway Bypass Status” : “Normal” means in
the status of waterway; “abnormal” means in the
status of bypass.
“Pre&Post Cond. Compa. Bypass or not”:
“Forbid” means won’t carry out bypass even if
compare failed; “OK” means carrying out bypass
when compare failed.
HCO3- setting menu

Prime
Stopped In the setting menu of HCO3- , setting its
HCO3- SetUp KEY
HCO3-(mmol/l) STANDARD:35
concentration and running time.
0 1
42 The standard value is 35mmol/L.
40
2 3
35 4 5
6 7
30
28 8 9
0 1 2 3 4 5 6
TIME(H) <- ->
HCO3- 038 mmol/l Run Time 200 min
Return OK
Other setting menu
Prime
Stopped
Dialysate temperature, bridging flow, spare
Other Setting KEY
pump flow, flow pump time and flow, beginning
36.5 ℃ 200 0 1
Dialysis Temp. Spare P. Flux ml/min
heparin pump flow and time, time of prime
Flow P. Flux 10.0 ml/h Bridging Flux 080 ml/min 2 3 stopped and waterway rinse can be set in this
Regard Spare P. NO 4 5 menu.
Flow Time 3 : 30 as Blood P. YES
6 7 You can select spare pump to be used as
Start Flow P. Flow Pump
8 9 blood pump, also this selection can be canceled

Start Hep. Flux 05.0 ml/h Start Hep. Time 05 min
<- -> in this menu.
Prime stop
010 min Dialysis times 0042 Times
Water run time
Return OK Use flow pump to start flow pump.

Shut off menu

Prime
Stopped Optional turn off, restart and cancel in the turn
Setting Select KEY off menu.
0 1
2 3
Shut off system g
4 5
Shut Off Restart Cancel
6 7
Other Setting Shut Off 8 9
Common Setting <- ->
Blood Pump 210 ml/min BP Volume 000.0 L
Return OK
Cleanness menu
Disinfection
Stopped List the information for cleanness description.
Display the cleanness mode to be used, use
600 400 300

According to suggestion, do operation on suction tubes of liquid(A) and
liquid(B)
function key to select and start cleanness mode
15.5 Connect dialysate supply/return tubes of dialyzer to the port of machine
500 300 250
15 Rinse time is 10 mins needed.
400 200 200 Please don't stop it during hot disinfection of disfection process
14.5
300 100 150 The disinfection solution used in disinfection and hot disinfection is
14 confected by the defined formula

200 0 100
Not allowed to return to other modes if the disinfection or hot disinfection
13.5
100 -100 50 has not been completed
13 The machine must go through disinfection or hot disinfection process
0 -200 0
after every treatment every time
12.5
-100 -300 -50
mmHg mmHg mmHg mS/cm
06.01
Rinse Disinfect Hot Dis. Return MON 15:03
Cleanness program menu(such as disinfection)

Disinfection
Stopped List the information for cleanness description.
Display the cleanness mode to be used, use

Cond. Time Left Time Left function key to select and start cleanness mode
30.0 ℃
600 400 300
15.5 00.1 mS/cm 0:36
500 300 250
15
needed.
400 200 200
14.5
300 100 150
14
200 0 100
13.5
100 -100 50
13 Rinse Disinfect
0 -200 0
12.5
1%
1%
-100 -300 -50
06.01

4.10 Using menu—parameter setting

Stopped Lower Temp alarm Priming menu.
Press “Setting” key on priming menu.
UF Goal
Screen displays setting selection menu.
UF Pump
0000 ml

Bypass

Blood Pump
Blood Pump
Next Page
0220 ml/min
01.01
Note:
Every time the dialysis machine is turned on , the following items will
automatically be restored into the default value: dialysis time (4h), the ultrafiltration
preset volume (0ml), ultrafiltration curve (0), sodium curve (0), isolate ultrafiltration
set time (30min), isolate ultrafiltration total for double needles(800ml), isolate
ultrafiltration total for single needle (400ml), heparin time(3:30), the spare pump is
serving as blood pump (no), conductance comparison between predialysis and
postdialysis is bypassed or not (yes), the venous transmembrane pressure
(200mmHg), arterial transmembrane pressure (400mmHg), transmembrane
pressure span (400mmHg), sodium base value (140), conductance span (1.0).
4.10.1 Set flux of blood pump
Prime
Stopped Press the fig. (flux of blood pump) which need
Setting Select KEY modifying, the fig. Color shows black background
0 1 and white font.
2 3 Press again the fig. in keyboard, input the fig.
4 5 of flux demanded.
HCO3- Kt/V Selective range for flux of blood pump:
～460ml/min;
6 7
Pipe dia.ф6mm,20ml/min
Pipe dia.ф8mm,20ml/min～620ml/min.
Blood Pump 210 ml/min BP Volume 000.0 L Return OK

Prime
Stopped Set selection menu.
Setting Select KEY Press “Dialysis Setting” key, the screen will
0 1 display dialysis setting menu.
2 3
4 5
HCO3- Kt/V 6 7
4.10.2 Dialysis setting menu
Set dialysis time
Prime
Stopped The default dialysis time is 4:00.
Press the fig. (Dialysis Time) which need
modifying, the fig. color displays black
2 3 background and white font.
4 5 Re-press the fig. in keyboard, input the
UF Max 0000 ml/h Base Na+ 140 mmol/l 6 7 demanded time.
8 9 Selective range for dialysis time:
0000 150
～ 9:59.
UF Volume ml Na+ Max mmol/l
<- -> 0
Return OK
Set heparin time
Prime
Stopped Default heparin time in the menu is 3:30.
Press the fig. (Heparin Time) which need
2 3 background and white font.
UF Max 0000 ml/h Base Na+ 140 mmol/l 6 7 demanded time.
8 9 Selective range for heparin time:
0000 150
～ 9:59.
UF Volume ml Na+ Max mmol/l
<- -> 0
Return OK

Set heparin flux
Prime
Stopped Press the fig. (Heparin Flux) which need
background and white font.
4 5 demanded flux.
UF Max 0000 ml/h Base Na+ 140 mmol/l 6 7 Selective range for heparin flux:

8 9 0.1ml/h ～10ml/h.
<- ->
Return OK
Set UF volume
Prime
Stopped Press the fig. (UF Goal) which needs
4 5 demanded UF volume.
UF Max 0000 ml/h Base Na+ 140 mmol/l 6 7 Selective range for UF goal:

8 9 0 ～14400ml.
<- ->
Return OK
Set max. value of UF speed
Prime
Stopped Press the fig. (UF Max. value) which need
4 5 demanded UF Max.speed.
UF Max 0000 ml/h Base Na+ 140 mmol/l 6 7 Selective range for UF Max. value:

8 9 0 ～3600ml/h.
<- ->
Return OK

Set Na+ basic value

Prime
Stopped Press the fig. (Na+ basic value) which need
2 3
Re-press the fig. in keyboard, input the
4 5
demanded basic value.
Selective range for Na+ basic value:
8 9
136mmol/l ～ 145mmol/l.
<- ->
Return OK
Set Max.value of Na+ curve

Prime
Stopped Press the fig. (Na+ max. value) which need
2 3
4 5
demanded Na+ max.value.
Selective range for Na+ max.value:
8 9
146mmol/l ～150mmol/l.
<- ->
Return OK
Set Na+ conc. curve and UF curve

Prime
Stopped Press the fig. of Na+ conc.Curve, re-press
the fig. in keyboard, and input the demanded Na+
conc. Curve graph.

2 3
Na+ conc. Curve graph: 0 ～ 7.
4 5
Press the fig. of UF curve, re-press the fig. in
8 9
UF Volume 0000 ml Na+ Max 150 mmol/l keyboard, and input the demanded UF Curve
<- -> graph.
Return OK UF Curve graph: 0 ～ 7.
After setting all the parameter, press “OK” key.

Press “Return” key, screen return to set
selection menu.

Prime
Setting Select KEY Press “Advanced Setting” key, the screen will
0 1 display dialysis setting menu.
2 3
4 5
HCO3- Kt/V 6 7
Prime
Stopped Passport login menu.
Password Logon KEY
Input the preset passport in the keyboard,
0 1
Password ： press “OK” key, and screen display senior set
2 3
menu.
4 5
Code: 3721
6 7
8 9
<- ->
Rerurn OK
4.10.3 Advanced setting menu
Set V.P. span

Prime
Stopped Press the fig. (V.P span) which need
0 1
2 3
A.P. Span 200 mmHg Lower Temp 34.5 ℃ 4 5
demanded V.P. span.
Blood Pump 8mm 6 7 Selective range for V.P. span:
TMP. Span 400 mmHg
Pipe dia.
～220mmHg.
7mm
8 9 50mmHg
Spare Pump 8mm
Pipe dia. 7mm <- ->
Return OK

Set A.P. span
Prime
Stopped Press the fig. (A.P span) which need
0 1
A.P. Span 200 mmHg Lower Temp 34.5 ℃ 4 5 demanded A.P. span.
Blood Pump 8mm 6 7 Selective range for A.P. span:
TMP. Span 400 mmHg
Pipe dia.
～420mmHg.
7mm
8 9 100mmHg
Spare Pump 8mm
Pipe dia. 7mm <- ->
Return OK
Set TMP span

Prime
Stopped Press the fig. (TMP span) which need
0 1
2 3
demanded TMP. span.
Blood Pump 8mm 6 7 Selective range for TMP. span:
TMP. Span 400 mmHg
Pipe dia.
～420mmHg.
7mm
8 9 100mmHg
Spare Pump 8mm
Pipe dia. 7mm <- ->
Return OK
Set conductivity span

Prime
Stopped Press the fig. (Cond. span) which need
0 1
2 3
demanded cond. span.
Blood Pump 8mm 6 7 Selective range for cond. span:
TMP. Span 400 mmHg
Pipe dia.
～1.6mS/cm.
7mm
8 9 0.8mS/cm
Spare Pump 8mm
Pipe dia. 7mm <- ->
Return OK

Set upper temp. alarm
Prime
Stopped Press the fig. (Upper temp.) which need
0 1
2 3
demanded upper temp. value.
Blood Pump 8mm 6 7 Selective range for upper temp. alarm:
TMP. Span 400 mmHg
Pipe dia.
℃～40℃.
7mm
8 9 37.5
Spare Pump 8mm
Pipe dia.
7mm <- ->
Return OK
Set lower temp. alarm

Prime
Stopped Press the fig. (Lower temp.) which need
0 1
2 3
demanded lower temp. value.
Blood Pump 8mm 6 7 Selective range for lower temp.alarm:
TMP. Span 400 mmHg
Pipe dia.
℃～35.5℃.
7mm
8 9 33.5
Spare Pump 8mm
Pipe dia. 7mm <- ->
Return OK
Set dialysate flux

Prime
Stopped Press the fig. (Dialysate flux) which need
0 1
2 3
demanded flux.
Blood Pump 8mm 6 7 Selective range for dialysate flux:
TMP. Span 400 mmHg
Pipe dia.
～800ml/min.
7mm
8 9 300ml/min
Spare Pump 8mm
Pipe dia.
7mm <- ->
Return OK

Set pump dia. Of blood pump(spare pump)
Prime
Stopped ○” beside the set fig. of pipe dia., it
Press “
displays“⊙”, which means it has been set.
0 1
The selective range of pipe dia. for blood
2 3
pump spare pump: ф7mm
ф8mm
Blood Pump 8mm 6 7
TMP. Span 400 mmHg
Pipe dia. 7mm
8 9
Spare Pump 8mm
Pipe dia. 7mm <- ->
Return OK
Alarm volume adjustment

Prime
Stopped On the volume line, move the indicator position
to adjust the alarm volume, towards left (volume
0 1
reduced) or towards right (volume increased).
2 3
Blood Pump 8mm 6 7
TMP. Span 400 mmHg
Pipe dia. 7mm
8 9
Spare Pump 8mm
Pipe dia. 7mm <- ->
Return OK
Display the record stored by conductivity
Prime
Stopped This menu can display the conductivity data
Tube of Hep
records for every minute in every treatment by
Adv. set Cond. save Temp. save Reserve
0 1
Time Pre. Back. Mix. A Upper Lower Bypass
Cond. Cond. Cond. Cond. Limit Limit Status
pressing ”Cond. save”, including time,
00:01 16.9 00.0 00.1 00.0 14.5 13.5 0002 2 3
00:02 15.2 00.1 00.1 00.1 15.5 14.5 0005
pre-dialysis conductivity, post-dialysis
00:03 14.9 00.1 00.1 00.1 15.5 14.5 0005
4 5
00:04 14.7 00.1 00.1 00.1 15.5 14.5 0005 conductivity, mixture conductivity, conductivity A,
00:05 14.4 11.0 00.1 00.1 15.0 14.0 0000
00:06 14.3 11.8 00.3 00.3 15.0 14.0 0000 6 7 conductivity upper limit setting value,
00:07 14.3 10.6 00.8 01.1 15.0 14.0 0000
00:08
00:09
14.2
14.2
05.9
08.9
03.2
04.4
03.7
04.8
15.0
15.0
14.0
14.0
0000
0000
8 9 conductivity lower limit setting value and the
<- ->
00:10 14.1 07.4 05.4 05.7 15.0 14.0 0000
00:11
00:12
14.1
14.1
07.8
07.6
05.7
06.0
06.0
06.2
15.0
15.0
14.0
14.0
0000
0000
reasson to start bypass, which the machine will
Date: 2008.12.01 09:30 Times: 0001 Page: 0001/0003
Profile Pre. record Next record Pre. page Next page
Return OK save them by itself automatically.
0000: Running normal and there is no need to
start bypass;
0001: Bypass started is choosed;
0002: Conductivity upper limit is incorrect and
start bypass;

0003: Conductivity lower limit is incorrect and

start bypass;
0004: Temperature upper limit is incorrect and
start bypass;
0005: Temperature lower limit is incorrect and
start bypass;
0006: Pre-dialysis and post-dialysis
comparison failure and start bypass;
0007: Cond≥15.2mS/cm;
0008: Cond≤13.0mS/cm.
Last conductivity data records can be checked
by pressing “Pre. record” and the last one can be
checked by pressing “Next record”; If there is
many pages in current conductivity data records,
“Pre. page” or “Next page” can be pressed.
The menu will display as followed if “Profile” is
pressed
Prime
Stopped This menu can display the profile records
information of pre-dialysis conductivity,
0 1
16.0
Pre.
post-dialysis conductivity, mixture conductivity
Cond.
15.5
2 3
15.0
and Na+.
Back 4 5
14.5 Cond. White: Pre-dialysis conductivity;
14.0
6 7 Dark blue: Port-dialysis conductivity;
Mix.
13.5 Cond.
13.0
8 9 Green: Mixture conductivity;
12.5 Na+
<- -> Light blue: Na+ concentration;
～16.0 mS/cm;
12.0
(mS/cm) 1 2 3 4 5 6 (Hour)
Date: 2008.12.01 09:30 Times: 0001
Return OK Conductivity Scope: 12.0
～
Date Pre. record Next record Reserve Reserve
Time scope: 0 6 hour.

Press “Pre. record” or “Next record” can
display last or next conductivity profile records.
The menu will be displayed as above if “Date”
is pressed.

Display the record stored by temperature
Prime
Stopped The menu will display the temperature data
Tube of Hep
records for every minute in every treatment by
Adv. set Cond. save Temp. save Reserve
0 1
Time Pre. Back. Mix. A Temp. Chamb. Goal of
Temp. Temp. Temp. Temp. Setting Temp. heat Ch.
pressing “Temp. save”, including time,
00:01 24.7 24.8 24.6 24.8 36.5 39.6 27.5 2 3
00:02 32.0 31.6 32.9 33.3 36.5 36.3 35.2
pre-dialysis temperature, post-dialysis
00:03 33.1 32.9 33.9 34.1 36.5 37.3 35.7
4 5
00:04 33.8 33.8 34.4 34.6 36.5 36.9 36.2 temperature and mixture temperature,
00:05 35.2 32.9 35.8 35.8 36.5 37.8 37.2
00:06 35.7 32.2 36.3 36.2 36.5 38.0 37.5 6 7 Temperature A, Temperature setting value,
00:07 35.9 32.5 36.4 36.4 36.5 39.8 38.3
00:08
00:09
36.2
36.4
34.3
33.3
36.7
36.9
36.7
36.7
36.5
36.5
38.2
39.7
38.0
38.3
8 9 Heating chamber temperature and Goal of heat
<- ->
00:10 36.5 34.6 36.9 36.7 36.5 39.6 38.2
00:11
00:12
36.5
36.7
34.6
34.4
37.2
37.2
36.9
36.9
36.5
36.5
40.7
39.0
38.3
38.2
chamber,which the machine will save it by itself
Date: 2008.12.01 09:30 Times: 0001 Page: 0001/0002
Profile Pre. record Next record Pre. page Next page
Return OK automatically.
Last temperature data records can be checked
by pressing “Pre. record” and the last one can be
checked by pressing “Next record”; If there is
many pages in current temperature data records,
“Pre. page” or “Next page” can be pressed.
The menu will display as followed if “Profile” is
pressed
Prime
Stopped This menu can display the profile records
information of pre-dialysis temperature,
0 1
39.5
Pre.
post-dialysis temperature, mixture temperature
39.0 Temp.
2 3
38.5
and temperature A.
38.0
Back 4 5
37.5 Temp.
White: Pre-dialysis temperature;
37.0
36.5 6 7 Dark blue: Port-dialysis temperature;

Mix.
36.0 Temp.
35.5 8 9 Green: Mixture temperature;

35.0
<- ->
A
34.5 Temp.
Light blue: Temperature A;
～39.5℃;
34.0
℃ 1 2 3
Date: 2008.12.01 09:30
4 5
Times: 0001
6 (Hour)
Return OK Temperature Scope: 34.0

～
Date Pre. record Next record Reserve Reserve
Time scope: 0 6 hour.

Press “Pre. record” or “Next record” can
display last or next temperature profile records.
The menu will be displayed as above if “Date”
is pressed.

Set tube diameter of heparine pump

Prime
Stopped Press down “Tube of Hep” key, can set heparin
Adv. set Cond. save Temp. save Reserve Tube of Hep tube diameter on this submenu.
0 1
Tube diameter by manual
Tube diameter of heparin pump divides into by
of heparin P. 2 3
Choose auto.
manual and choose automatically.
Choose heparin
10ml
4 5
○
Press “ ” beside the set fig. of pipe dia., it
displays“⊙”, which means it has been set.
tube diameter
by manual
20ml 6 7
30ml
8 9
Heparin pump tube diameter size has 10ml,
<- ->
20ml and 30ml.
Return OK
When heparin tube diameter choose

Prime
Stopped
automatically ,the heparine pump tube diameter
0 1 size is unselective.
Tube diameter by manual
of heparin P. 2 3
Choose auto.
4 5
10ml
Choose heparin
tube diameter
by manual
20ml 6 7
30ml
8 9
<- ->
Return OK

selection menu.

Prime
Setting Select KEY Press “Work Mode” key, screen displays work
mode set menu.
0 1
2 3
4 5
HCO3- Kt/V 6 7
4.10.4 Work mode setting menu
Set work mode

Prime
Stopped Working mode, Disinfect mode and Hot Dis.
Work Mode Setting
mode and Blood mode can be set by pressing
A : B : H2O Worke Mode Disinfect Mode Hot Dis. Mode "working mode" button.
1:1.225:32.775 HD
1:1.830:34.000 ISO UF
Citric acid Heat+Citric acid The bicarbonate concentrate, RO water mixing
Peracetic acid Heat
1:1.830:34.000
1:2.100:34.000 ratio(A:B:water) is set by default and it can not be
Acetate
changed on this menu.
Na + ：A + B = ?
105 + 35 = 140
When the work mode , disinfect mode, hot dis.
A+B Mode
Blood Mode
(Needle) Mode, A+B mode or bloodway mode is changed,
A+B Double
A+B （Dry Powder） Single Return OK the menu will display clue on relative
confirmation or operation error as followed.
To confirm the modification, click "OK" button,
otherwise click "Cancel" button.

Prime
Stopped Press “ISO UF ‘O’ ”, it displays “ ”, which
Work Mode Setting
Work Mode ISO UF Set Conn. Draw Reserved Reserved Reserved Reserved means “ISO UF” mode has been selected.
A : B : H2O Worke Mode Disinfect Mode Hot Dis. Mode
1:1.225:32.775 HD
Citric acid Heat+Citric acid
1:1.830:34.000 ISO UF
Peracetic acid Heat
1:1.830:34.000
1:2.100:34.000
Acetate
Na + ：A + B = ?
105 + 35 = 140
Blood Mode
A+B Mode (Needle)
A+B Double
（
A+B Dry Powder ） Single Return OK
Prime
Stopped Confirmation on work mode modification.
Work Mode Setting
Work Mode ISO UF Set Conn. Draw Reserved Reserved Reserved Reserved Click “OK” to confirm modicafication,
A : B : H2O Work Mode Disinfect Mode Hot Dis. Mode
otherwise click "Cancel" button.
1:1.225:32.775 HD Citric acid Heat+Citric acid
1:1.260:32.740 ISO UF Confirm
1:1.830:34.000 Are you sure to change 'Work Mode'?
1:2.100:34.000 Hemodialysis mode (HD)
? Change to be:
Acetate
Na +: A + B = ? ISO Utrafiltration(ISO UF)
105 + 35 =140 OK Cancel
Blood Mode
A+B Mode (Needle)
A+B Double
（
Set A+B (Dry powder) common dialysis mode
Prime
Stopped Press “A+B (Dry Powder) ‘O’ ”, it displays
Work Mode Setting
Work Mode ISO UF Set Conn. Draw Reserved Reserved Reserved Reserved “ ”, which means “A+B (Dry Powder)” mode
A : B : H2O Worke Mode Disinfect Mode Hot Dis. Mode has been selected.
1:1.225:32.775 HD
1:1.830:34.000 ISO UF
Peracetic acid Heat
1:1.830:34.000
1:2.100:34.000
Acetate
Na + ：A + B = ?
105 + 35 = 140
Blood Mode
A+B Mode (Needle)
A+B Double
A+B（Dry Powrer） Single Return OK

Prime
Stopped Confirmation on A+B mode modification.
Work Mode Setting
Click “OK” to confirm modicafication, otherwise
A : B : H2O Work Mode Disinfect Mode Hot Dis. Mode click "Cancel" button.
1:1.225:32.775 HD Citric acid Heat+Citric acid
1:1.830:34.000 Are you sure to change 'A+B mode'?
1:2.100:34.000 'A+B' change to be 'A+B(Dry powder)'
?
Acetate
Na +: A + B = ?
105 + 35 = 140 OK Cancel
Blood Mode
A+B Mode (Needle)
A+B Double
（
Set Disinfect mode

Prime
Stopped Press “Peracetic acid ‘O’ ”, it displays “ ”,
Work Mode Setting
Work Mode ISO UF Set Conn. Draw Reserved Reserved Reserved Reserved which means “Peracetic acid” mode has been
A : B : H2O Worke Mode Disinfect Mode Hot Dis. Mode selected.
1:1.225:32.775 HD
1:1.830:34.000 ISO UF
Peracetic acid Heat
1:1.830:34.000
1:2.100:34.000
Acetate
Na + ：A + B = ?
105 + 35 = 140
Blood Mode
A+B Mode (Needle)
A+B Double
（
Prime
Stopped Confirmation on disinfect mode modification.
Work Mode Setting
Click “OK” to confirm modicafication,
A : B : H2O Work Mode Disinfect Mode Hot Dis. Mode otherwise click "Cancel" button.
1:1.225:32.775 HD
1:1.830:34.000 Are you sure to change 'Disinfect Mode'?
1:2.100:34.000 Citric acid
? Change to be:
Acetate
Peracetic acid
Na +: A + B = ?
105 + 35 = 140
OK Cancel
Blood Mode
A+B Mode (Needle)
A+B Double
（
Set Hot Dis. Mode

Prime
Stopped Press“Heat ‘O’ ”, it displays “ ”, which
Work Mode Setting
Work Mode ISO UF Set Conn. Draw Reserved Reserved Reserved Reserved means “Heat” mode has been selected.
A : B : H2O Worke Mode Disinfect Mode Hot Dis. Mode
1:1.225:32.775 HD
1:1.830:34.000 ISO UF
Peracetic acid Heat
1:1.830:34.000
1:2.100:34.000
Acetate
Na + ：A + B = ?
105 + 35 = 140
Blood Mode
A+B Mode (Needle)
A+B Double
Prime
Stopped Confirmation on hot dis. mode modification.
Work Mode Setting
1:1.225:32.775 HD
1:1.830:34.000 Are you sure to change 'Hot Dis. Mode'?
1:2.100:34.000 Heat+Citric acid
? Change to be:
Acetate
Heat
Na +: A + B = ?
105 + 35 = 140
OK Cancel
Blood Mode
A+B Mode (Needle)
A+B Double
Set single needle treatment

Prime
Stopped ⊙
Select “Single ‘O’ ”, it displays “ ”, that means
Work Mode Setting
single needle mode has been selected.
A : B : H2O Worke Mode Disinfect Mode Hot Dis. Mode During single needle treatment, blood pump
1:1.225:32.775 HD
1:1.830:34.000 ISO UF
Citric acid Heat+Citric acid can rotate according to preset value, if blood
Peracetic acid Heat
1:1.830:34.000
1:2.100:34.000 pump stop, the flux is 0, please refer to ‘BP
Acetate
Volume” to get the blood volume per unit time.
Na + ：A + B = ?
105 + 35 = 140
Blood Mode
A+B Mode (Needle)
A+B Double
（

Prime
Stopped Confirmation on bloodway mode modification.
Work Mode Setting
1:1.225:32.775 HD
1:1.830:34.000 Are you sure to change 'Blood Mode'?
1:2.100:34.000 Double Needle Treatment
? Change to be:
Acetate
Single Needle Treatment
Na +: A + B = ?
105 + 35 = 140
OK Cancel
Blood Mode
A+B Mode (Needle)
A+B Double
Set ISO UF parameter
Prime
Stopped Click "ISO UF setting" button, ISO UF time,
Work Mode Setting
double needle ISO UF volume and sinle needle
ISO UF volume can be set in this menu.
0 1
ISO UF Time 0 : 30 Optional range of ISO UF: 0 ~ 9:59;
2 3
4 5
Optional range of double needle ISO UF: 0 ~
Double Needle
0800 ml
ISO UF Goal
6 7 8000ml;
Single Needle
0400 ml 8 9 Optional range of single needle ISO Ue: 0 ~
ISO UF Goal
2000ml.
Software edition is: V8.XX.1 AMI11
Return OK
Press the data needed to be modified and the
data will be displayed in white and with black
background, then press the number in the
keyboard for input. After setting, click "OK"
button to confirm.
Pipe connection diagram in HD (ISO UF) mode

Prime
Stopped Press "Conn. Draw" button and this sub-menu
Work Mode Setting
can display HD (ISO UF) and hotrinse.
B. P. The Left diagram is the pipe diagram in HD
Heparin HD(ISO UF)
(ISO UF) mode.

Reserved
A. P.
Reserved
Dialyzer
Spare P.
Hot Disfect.
Air Bubble
Reserved
Blood Level V. P. Return OK
Prime
Stopped The Left diagram is the pipe diagram in rinse
Work Mode Setting
and hortinse.
A Port B Port supply port return port
To machine To machine To machine To machine HD(ISO UF)
Reserved
Reserved
Hot disfect.
Reserved
rinse,hot disinfection,tube connection draw

Return OK

selection menu.

Prime
Setting Select KEY Press “Time Setting” key, screen time setting
0 1 menu.
2 3
4 5
HCO3- Kt/V 6 7
4.10.5 Time setting menu
Setting date
Prime
Stopped Press the date which need to revise,the color
Time Setting KEY
of it display black background.and white font.
0 1
Then press the figure of the keyboard,and
Year Month Date
2 3
20 08 01 01 input the needed date.
4 5
Hour Minute Day
6 7
00 03 7
8 9
<- ->
Return OK
Setting time
Prime
Stopped Press the time and week which need to revise,
Time Setting KEY
the color of it display black background, and
0 1
white font.
Year Month Date
2 3
20 08 01 01 Then press the figure of the keyboard, and
4 5
Hour Minute Day input the needed time and week.
6 7
00 03 7
8 9
<- ->
Return OK

Setting up limit
Prime
Stopped Press the date of Up Limit needed to be
Time Setting KEY
modified and input necessary value.
0 1
～2mS/cm.
16.5 16.5 16.5 16.0

Scope of Up Limit: 0.5
Pre.Cond. Mix Cond.
16.0
20.6
16.0 16.0
00.1
15.0 2 3
15.5 15.5 15.5 14.0
15.0 Post Cond. 15.0 15.0 Cond. A 13.0

4 5
14.5 00.1 14.5 14.5 00.1 12.0
14.0 14.0 14.0 11.0

6 7
Up Limit (A:B:H2O)
13.5
01.0
13.5 13.5
1:1.225:32.775
10.0
8 9
13.0 13.0 13.0 1:1.260:32.740 9.0
12.5
Low Limit
12.5 12.5 1:1.830:34.000
1:2.100:34.000
8.0 <- ->
：
12.0 12.0 12.0 7.0
01.0 Na + A + B= ?
11.5 11.5 11.5 105 + 35 = 140 6.0
mS/cm mS/cm mS/cm mS/cm
Return OK
Setting low limit

Prime
Stopped Press the date of Low Limit needed to be
Time Setting KEY
modified and input necessary value.
0 1
～2mS/cm.
16.5 16.5 16.5 16.0

Scope of Low Limit: 0.5
Pre.Cond. Mix Cond.
16.0
20.6
16.0 16.0
00.1
15.0 2 3
15.5 15.5 15.5 14.0
15.0 Post Cond. 15.0 15.0 Cond. A 13.0

4 5
14.5 00.1 14.5 14.5 00.1 12.0
14.0 14.0 14.0 11.0

6 7
Up Limit (A:B:H2O)
13.5
01.0
13.5 13.5
1:1.225:32.775
10.0
8 9
13.0 13.0 13.0 1:1.260:32.740 9.0
12.5
Low Limit
12.5 12.5 1:1.830:34.000
1:2.100:34.000
8.0 <- ->
：
12.0 12.0 12.0 7.0
01.0 Na + A + B= ?
11.5 11.5 11.5 105 + 35 = 140 6.0
mS/cm mS/cm mS/cm mS/cm
Return OK
Setting bypass
Prime
Stopped
Press “OK” means it will go bypass when
Time Setting KEY
comparison between pre-dialysis conductivity
0 1
and post-dialysis conductivity is failing.
Pre & Post Cond. Forbid
Check Phase 000 comp. bypass or not OK
2 3
Comp. time 000 S
4 5
Conductivity
Dif. time
000 S
6 7
P-cond.Check
Dif. times
000 8 9
Comp. Result
of Pre.& Post
Not Compare
<- ->
Waterway Normal
Bypass Status
Return OK

selection menu.

Prime
Setting Select KEY Press “HCO3-” key, screen displays HCO3- set
0 1 menu.
2 3
4 5
HCO3- Kt/V 6 7
4.10.6 HCO3- setting menu
Setting HCO3- concentration

Prime
Stopped Press figure of HCO3- concentration which
HCO3- SetUp KEY
needed to revise,the color of it display black
0 1
42
background.and white font.
40
2 3
Then press the number of the keyboard,and
35 4 5
input the its concentration.
6 7
30 Optional scope of HCO3- concentration:
28
0 1 2 3 4 5 6
8 9
28mmol/L ～ 42mmol/L.
TIME(H) <- ->
Return OK
Setting running time

Prime
Stopped Press figure of running time which need to
HCO3- SetUp KEY
revise,the color of it display black
0 1
42
background.and white font.
40
2 3
Then press the number of the keyboard,and
35 4 5
input the its needed time.
30
6 7
Optional scope of running time : 0 ～ 6 h.
28 8 9
0 1 2 3 4 5 6
TIME(H) <- ->
Return OK


selection menu.

Prime
Setting Select KEY Press “Kt/V” key, screen displays Kt/V set
0 1 menu.
2 3
4 5
HCO3- Kt/V 6 7
4.10.7 Kt/V setting menu
Set dialysis volume measure

Prime
Stopped In the menu of “Patient data”, patients’ height
dialysis volume measure
Kt/V URR SP12pool nPCR TACurea

Patient data and weight can be set through keyboard, and
Height Weight
Calibration should be done when Kt/V tests inaccurately.
Ban 170 cm 060 kg sex can be selected.
In calibration, machine should be in prime Kt/V function
status. Precondition on successful calibration: Pre-dialysis OK
Male
conductivity and post-dialysis conductivity should be in the range of Gender
Female
13.0-15.0 mS/cm, the error between them should be less than 1.0 mS/cm.
keyboard
Begin Calibration 0%
1 2 3
4 5 6
Pre-dialysis 00.0 mS/cm 7 8 9
0 OK
Post-dialysis 00.0 mS/cm
Exit
Kt/V Calibration
Prime
Stopped Press key of “Kt/V” and it will display Kt/V

Patient data
calibration menu.
○
Height Weight
Calibration should be done when Kt/V tests inaccurately.
Ban 170 cm 060 kg
In calibration, machine should be in prime Kt/V function Press“ ”in front of “OK” key to start Kt/V
⊙
status. Precondition on successful calibration: Pre-dialysis OK
Male
conductivity and post-dialysis conductivity should be in the range of
13.0-15.0 mS/cm, the error between them should be less than 1.0 mS/cm.
Gender
Female function. If it displays “ ”, it means Kt/V function
keyboard
is already started.
Begin Calibration 0%
1 2 3
This menu displays pre-dialysis and
4 5 6
Pre-dialysis 00.0 mS/cm 7 8 9 post-dialysis value.
Post-dialysis 00.0 mS/cm
0 OK In priming condition, press “start calibration”
Exit
key to process Kt/V calibration.
The precondition of calibration successful is
showed as this menu.
URR
Prime
Stopped Press the key of “URR” and URR menu will be

Patient data
Height Weight
displayed.
Dialysis urea reduction rate just reflects reduction percentage of solute
170 cm 060 kg
instead of actula solute-removing index. >70% indicates dialysis adequacy. In URR menu, the first pre-dialysis BUN
Only for reference! Please refer to actual clinical for analysis. Male
Gender
Female volume and the first post-dialysis BUN volume
First pre-dialysis BUN: 00.0 mmol/l keyboard
can be set.
1 2 3
First post-dialysis BUN: 00.0 mmol/l Optional scope of the first pre-dialysis BUN
Dialysis urea reduction rate(URR): 0 % 7
4 5
8
6
9
volume : 0 ～ 50 mmol/l.
0 OK Optional scope of the first post-dialysis BUN
Exit volume : 0 ～ 50 mmol/l.
After input finished, declining rate of dialysis
urea (URR) will be worked out automatically.
SRI2pool
Prime
Stopped Press“SRI2pool” key and it will display the

Patient data
Height Weight
menu“SRI2pool”.
Pool II solute clearance index, a parameter calculated by urea kinetic
170 cm 060 kg
model, indicates solute removing index in dialysis. SRI>70% indicates In the SRI2pool menu, the first pre-dialysis
dialysis adequacy. Only for reference! Please refer to actual clinical Male
for analysis. Gender
Female BUN volume,the first post-dialysis BUN volume
First pre-dialysis BUN: 00.0 mmol/l keyboard
and UF volume can be set.
1 2 3
First post-dialysis BUN: 00.0 mmol/l Optional scope of the first pre-dialysis BUN
UF Volume 0000 ml
4
7
5
8
6
9
volume : 0 ～ 50 mmol/l.
0 OK Optional scope of the first post-dialysis BUN
～ 50 mmol/l.
Pool II solute clearance index: 0 %
(SR12pool):
Exit volume : 0
Optional scope of UF volume : 0 ～ 9999ml.
After input finished, solute clearance index of
Chamber II (SRI2pool) can be worked out
automatically.
nPCR
Prime
Stopped Press the key of “nPCR”, it will display the

Patient data
Height Weight
“nPCR” menu.
Normal protein catabolism rate. The protein intakes for dialysis patients
170 cm 060 kg
should be more than 1.1(g/kg.d), then nPCR will be more than 1.1(g/kg.d) In “nPCR” menu, dialysis interphase Urine
too. When nPCR is less than 0.8(g/kg.d), it means malnutrition and Male
inadequate dialysis rate will be high. Only for reference! Please refer
to actual clinical for analysis.
Gender
Female volume, dialysis interval time, dialysis interphase
Urine volume in dialysis interphase: 0000 ml
keyboard
inner urine BUN, the first post-dialysis BUN, the
1 2 3
Interval time of dialysis: 0000 min
second pre-dialysis BUN can be set separately.
4 5 6
Urine BUN in dialysis interphase: 00.0 mmol/l
Optional scope of dialysis interphase urine
～ 9999ml.
7 8 9
First post-dialysis BUN: 00.0 mmol/l
Second pre-dialysis BUN: 00.0 mmol/l

0 OK volume : 0
Normal protein catabolism rate(nPCR): 0 g/kg.d Exit Optional scope of the dialysis interval time :

0 ～ 9999min.
Optional interphase inner urine BUN: 0 ～
50mmol/l.
Optional scope of the first post-dialysis
BUN : 0 ～ 50 mmol/l.
Optional scope of the second pre-dialysis
After input finished, the standard protein
decomposing rate (nPCR) can be worked out
automatically.
TACurea
Prime
Stopped Press the key of “TACurea”, it will

Patient data
Height Weight
display ”TACurea” menu.
Time Average Concentrations of Urea reflects synthesis situation of dialy-
170 cm 060 kg
sis urea remov index and patient's protein metabolism. TACurea>50(mg/d) In” TACurea” menu, the first pre-dialysis BUN,
means reference index for dialysis adequacy. It indicates cardiovascular, Male
nervous system of alimentary canal and other long-term complications Gender
Female the first post-dialysis BUN, the second
increase. Only for reference! please refer to actual clinical for analysis.
First pre-dialysis BUN: 00.0 mmol/l

keyboard
pre-dialysis BUN, dialysis time and dialysis
1 2 3
First post-dialysis BUN: 00.0 mmol/l
interval time can be set.
Second pre-dialysis BUN: 00.0 mmol/l 4 5 6
Optional scope of the first pre-dialysis BUN :
～ 50 mmol/l.
Dialysis time: 0000 min 7 8 9
Dialysis interval time: 0000 min 0 OK 0
Time Average Concentrations
0 mg/dl
of Urea(TACurea):
Exit Optional scope of the first post-dialysis BUN :
0 ～ 50 mmol/l.
Optional scope of the second pre-dialysis
Optional scope of dialysis time: 0～ 9999min
Optional scope of dialysis interval time: 0 ～
9999min.
After input finished, time average
concentration of the urea (TACurea) can be
worked out automatically.

selection menu.

Prime
Setting Select KEY Press “Other Setting” key, screen displays
0 1 other setting menu.
2 3
4 5
HCO3- Kt/V 6 7
4.10.8 Other setting menu
Setting dialysate temp.
Prime
Stopped Press the fig. (Dialysate Temp.) which need
Other Setting KEY
Dialysis Temp. 36.5 ℃ 200 0 1
Spare P. Flux ml/min
Flow P. Flux 10.0 ml/h Bridging Flux 080 ml/min 2 3 Re-press the fig. in keyboard, input the
Regard Spare P. NO 4 5 demanded dialysate temp.
6 7 Selective range for dialysate temp.:
℃～39℃.
8 9 35
<- ->
Prime stop
Water run time 010 min Dialysis times 0042 Times
Return OK
Setting bridging flux

Prime
Stopped
Press the fig. (Bridging Flux) which need
Other Setting KEY
Regard Spare P. NO 4 5 demanded bridging flux.
6 7 Selective range for bridging flux:
～120ml/min.
8 9 50ml/min
<- ->
Prime stop
Return OK

Setting flux of flow pump

Prime
Stopped
Press the fig. (flow-pump flux) which need
Other Setting KEY
modifying; the fig. color displays black
36.5 ℃ 200 0 1
Regard Spare P. NO 4 5 demanded flux.
6 7 Selective range for flux of flow pump:
～ 10ml/h.
8 9 0.1ml/h
<- ->
Prime stop
Return OK
Setting adjust time

Prime
Stopped
Press the fig. (Adjust time) which need
Other Setting KEY
36.5 ℃ 200 0 1
Regard Spare P. NO 4 5 demanded time.
Flow Time 3 : 30
～ 9:59.
as Blood P. YES
6 7 Selective range for time: 0
8 9
<- ->
Prime stop
Return OK
Setting flux of spare pump

Prime
Stopped
Press the fig. (Spare Pump Flux) which need
Other Setting KEY
36.5 ℃ 200 0 1
Regard Spare P. NO 4 5 demanded flux.
6 7 Selective range for spare-pump flux:
～460ml/min;
8 9 Pipe dia.ф6mm,20ml/min
Pipe dia.ф8mm,20ml/min～620ml/min.
<- ->
Prime stop
Return OK

Setting pump acts as blood pump

Prime
Stopped Press “ ○” for yes ， it ⊙”,which
displays “
Other Setting KEY
means that spare pump acts as blood pump.
Dialysis Temp. 36.5 ℃ Spare P. Flux 200 ml/min 0 1
Flow P. Flux 10.0 ml/h Bridging Flux 080 ml/min 2 3

Regard Spare P. NO 4 5
6 7
8 9
<- ->
Prime stop
Return OK
Setting flux of heparin pump

Prime
Stopped
Press the digital of heparin pump flux which
Other Setting KEY
need to change, the digital displays black
36.5 ℃ 200 0 1
Flow P. Flux 10.0 ml/h Bridging Flux 080 ml/min 2 3 Then press digital in the keyboard and input
Regard Spare P. NO 4 5 needed flux.
Flow Time 3 : 30
～
as Blood P. YES
6 7 Range of flux of heparin pump can 0.1ml/h
8 9 10ml/h.
<- ->
Prime stop
Return OK
Setting time of heparin pump

Prime
Stopped Press the digital of heparin pump time which
Other Setting KEY
need to change, the digital displays black
Regard Spare P. NO 4 5 needed time
Flow Time 3 : 30
～ 20min.
as Blood P. YES
6 7 Time range of heparin pump: 0
8 9
<- ->
Prime stop
Return OK

Setting prime stop and waterway run time

Prime
Stopped
Press the digital of prime stop and waterway
Other Setting KEY
run time which need to change, the digital
36.5 ℃ 200 0 1
displays black background and white font.
Regard Spare P. NO 4 5 needed time
6 7 Time range of prime stop and waterway run:
～ 20min.
8 9 0
<- ->
Prime stop
Return OK

selection menu.

Prime
Stopped
Setting Select KEY Set selection menu.

0 1 Press “Shut Off” key, screen displays shut off
2 3 menu.
4 5
HCO3- Kt/V 6 7
4.10.9 Shut off menu
Shut Off
Prime
Stopped Press “Shut Off” key, then “OK” key, machine
Setting Select KEY can turn off automatically.
0 1
2 3
Shut off system g
4 5
6 7
Return OK
Restart
Prime
Stopped Press “Restart” key, then “OK” key, machine
Setting Select KEY can restart automatically.
0 1
2 3
Shut off system g
4 5
6 7
Return OK

Prime
Setting Select KEY Press “Return” key, screen displays priming
0 1 menu.
2 3
4 5
HCO3- Kt/V 6 7
4.10.10 Priming menu
Modify the range of alarm limit(i.e.: modify V.P. alarm limit)

Stopped Lower Temp alarm Prime rinse or dialysis menu.
Press ▲or ▼ key to modify the V.P. alarm

Conductivity Temperature UF Pump limit.
00.0 mS/cm 34.0 ℃
600 400 300
15.5
500 300 250
15
Na+
Heparin
400 200 200
14.5 Adjust
300 100 150 140 mmol/l
14 Bypass
200 0 100
Heparin Time
13.5
100 -100 50
13
3:30 Blood Pump
0 -200 0
12.5 Heparin Flux
-100 -300 -50
01.01
Calibration for Cond.

Stopped Lower Temp alarm If the actual value of cond. for dialysate is
different with the set Na+ conc., it can press

Conductivity Temperature UF Pump “Adjust” key continuously for two times, after
00.0 mS/cm 34.0 ℃
600 400 300
15.5
500 300 250
15
Na+
Heparin about ten mins, the actual value of cond. will be
400 200 200
automatically adjusted to the same with Na+

14.5 Adjust
300 100 150 140 mmol/l
14 Bypass
200 0 100
Heparin Time
100 -100 50
13.5
conc.
13
3:30 Blood Pump
0 -200 0
12.5 Heparin Flux
-100 -300 -50
01.01

4.11 Tone mute function
Press “ ” key on screen to cancel the
alarm voice.
The alarm info. won’t be displayed in text area
until the malfunction is resolved .
4.12 UF test
Press button “sampling port 1 of UF fluid”,

when UF sampling tube is bounced out, it means
the test the test has been started.. Please put
measure container on place of “sampling port 2
of UF fluid” and collect the liquid from UF
sampling tube.
After the test, comparing the UF dialysate (flow
out from sampling inlet) measure result with the
set UF volume to get the UF precision.

5 Treatment
5.1 Preparation work
5.1.1 Start to run AMI 11 Hemodialysis equipment
Note:
Please make sure the following preparation work has been done
before using the HD device.
1) The connection between the HD device and the RO water supply
system has been done.
2) The connection between the HD device and the drainage system
has been done.
3) The connection between the HD device and the power supply
system has been done.
When the hemodialysis machine is running, don't run the other device
which will transmit electromagnetic wave or radio wave as this kind of
device will bring work malfunction to hemodialysis machine.
5.1.1.1 A+B common dialysis mode
Put A/B concentration absorbed tube into

corresponding container, then connect the
dialysate supply and return tube onto dialyzer
respectively.

Withdraw the Dry powder frame
5.1.1.2 A+B (dry powder) common dialysis mode
Put A concentration absorbed tube into A

container, B concentration absorb tube into
A B
seat B, then connect dialysate supply and
return tube onto dialyzer separately.

Put bi-cartridge onto Dry powder frame
Open the water supplier system of RO water.
Open the power switch on the back of the

Dialysis Machine.
Press the key of “Power”, power-supply

indicator (green) shines.
The waterway of the hemodialysis will run.

5.1.2 Self-test of function
Condition of starting self-test:

Connect with power supply
Disinfection finished
Select Therapy Display selective therapy.

1:Place the suction tubes of liquid A&B into concentrate container respectively prior to
Press “ Hemodialysis ” （ or
“Hemoperfusion”）to access different self-test
running haemodialysis.
2:Press "Skip" button if no need self-test. mode.
3:Please call service engineer if self-test failed.
Hemodialysis Hemoperfusion Skip
Note:
In the procedure of test-self, if the system inspects that system didn’t
undergo the procedure of disinfection or it was not finished last time, the
system will run this procedure automatically, until it is finished.
The signal light (yellow) shine.
Lower Temp alarm

Self-test Lower Conductivity alarm Self-test menu 1 display.
Test Gear
Blood Level Normal Spare Pump Normal pump Test In-Pro. Function self-test start automatically.
Air Bubble Normal Heparin Pump Normal
Test Cond. The test steps in -precess will be highlighted
（refer to 4.9.2）.
system Test In-Pro.
Normal
Water Work Test Temp.
with color
V.P. preparation Test In-pro. system Test In-Pro.
If one function test didn’t pass, the failure

A.P. Normal Test Balance
Test in-pro
valve
information (for alarm) will be displayed in the
Test UF
TMP Normal pump Test in-pro text area.
Blood Pump Normal Test A/B
pump
Test in-pro
Temp. 23.0 ℃ Cond. 01.0 mS/cm Exit


Stopped Lower Temp alarm Enter into prime rinse menu (stop status)
automatically if the entire test passed.

UF Goal
UF Pump The prime rinse menu will display all the
0000 ml
Heparin parameters saved in last treatment.
UF Rate TMP Ven Art

Bypass

Blood Pump
Blood Pump
Next Page
0220 ml/min
01.01
Note ：
If the system didn’t pass the function self-test, please turn off the
machine and re-press “power” button for re-test.
If function self-test finished but one test is failed, it displays self-test
failure on menu, you can press “exit” key to skip this test step, and then
enter into prime rinse menu.
Warning:
Do undergo the disinfection before the first treatment.
5.1.3 The supply of the dialysate
Put the connector of A concentrate water tube (red) into the A concentration water container.
Put the connector of B concentrate water tube (blue) into the B concentration water container.
There are two ways of RO water supply in the following to choose:
1. RO water pipe supply liquor.
2. Container supply water let the container with the RO water supply the water.
Take 4.5 for reference in detail.

5.1.4 The installation of the injector
Rotate the knob of press head clockwise to

keep the press head move upwards and
downwards.
Pull the clamp of needle cartridge, outwards,

install the injector with full liquor into the press
head and pump holder.
Rotate the knob counterclockwise to fix the
press head.
Note :
Wings of injection should be in the fixed slot.
Refer to 4.2.2 for the name of parts

5.1.5 The installation of the blood pipe system
The sketch diagram of the blood pipe system
The installation of the blood pump pipe

Open the cover of the pump, put the entry of the blood pump pipe into the fixed trough, press the
switch of blood pump, the rotor will move slowly, the blood pump will enter into the space of two poles.
When the rotor move, the pump pipe will move into the pipe way, and fix the trough at last.
Adjust the elastic press of roll pole

Adjust the ball bearing of the rotor to adjust the screw, to adjust the degree of the tightness of the
pump pipeline.
If choosing other size of the pump pipe, do adjust the degree of the tightness of pump pipe.
Adjust ways: adjust the screw of the ball bearing of the pipe, increase or reduce the length. After the
pump pipe is installed, fill in a bag of saline water to the entry of the pipeline, hang in the place of 1 meter,
adjust the ball bearing pole and the screws, so as to make the ball bearing to press the pump pipeline
until the saline water won’t pour out, which is the best situation.
Refer to section 4.2.1 in order to familiar with the name of parts for reference.

Note:
1. Make sure that the pump pipe can be fully pressed by the two ball
bearings.
2. After the pump pipe is set up, take on the cover of pump, otherwise
the rotor won’t move.
The installation of the air trap device
Open the door of the air inspector, fix the vein

Pot into the air inspector, then close the door of the
air inspector.
Open the door of the venous line clamp, press

the switch of it (as the left diagram shows it). Then
open the venous line clamp, put the vein pipe into
the venous line clamp, and close the door of it.
Circumrotate the vein pressure measurement

pipe into the vein pressure port.
Press the “Adjust” key to adjust the level of the
vein pot, press to increase the blood level, and
to reduce the blood level.
Warning:
All the connection between the blood pipelines should be
Note:
operated in asepsis.between the blood pipelines should be operated in
All the connection
The .blood pipe should not twisted when the pipes are put into
asepsis
the system.

5.1.6 Adjust the injection bracket
When it is needed to adjust the height of the

injection bracket, take hold of the adjust knob of
the bracket, push it upwards to adjust the height
of the injection height.

5.1.7 The installation of the adjust- liquor connection
The hydronium in the dialysate is the main factor to decide the penetrative pressure of the dialysate,
which effects directly the concentration of the blood serum of the patient and the penetrative pressure. In
the process of the haemodialysis, adjust the concentration of the hydronium of the dialysate according to
the situation of the patient, to reach up to the excellent result.
According to the situation of the patient, when

adjusting the concentration of the hydronium by
adjusting the dialysate, the adjust connection
should be put in connect with the dialyzer.
Put the fast connector of the suppling pipe to
its port, then adjust the connect of the adjust
pump pipe.

5.1.8 The setting of parameter
Every time before the treatment, set up every parameter of the hemodialysis treatment according to
the actual situation of the patient.
For the ways to set up the parameters, please look the 4.9for reference.
Note:
During the treatment, the set parameters can be modified.
5.1.9 Na+ curve graph and UF curve graph
Be sure to set a series of value before select curve graph:

——Max value of Na+
——UF total volume
——UF time
——Max speed of UF
The below chart shows the possible combination of Na+ curve graph and UF curve graph:
+
Na curve graph
0 1 2 3 4 5 6 7
1
UF
curve 2
graph
3

5.1.10 The prime rinse and the air removing for the pipe before the treatment
5.1.10.1 The preparation work for prime rinse
（1） Put the tubes for A and B concentration liquor into the relevant pot. (Look 4.5.1 for reference).
（2） Connect the dialysate supplier pipe with the entry of the dialyzer, the reflux pipe with the outlet
of the dialyzer.
（3） Connect the two ends of blood line of dialyzer with the bag of saline water.
5.1.10.2 The operation of the prime rinse

Stopped Lower Temp alarm Prime rinse menu:
Press the key of “Prime”, the system will

UF Goal
UF Pump undergo the prime rinse to pipe.
0000 ml

Bypass

Blood Pump
Blood Pump
Next Page
0220 ml/min
01.01
Prime Current modes display the running info. on the

Running
screen.
The system inspects that the temperature and

Prime conductivity are suitable.
Running
“Finish info.” will display in text area.
But the prime rinse will go on.
Press “prime rinse”, to stop prime rinse.
Note:
In the process of prime rinse, if the system inspect that there are
unusual things, the system will send off warning voice, the signal (red)
will shine, and the alarm information will display in the text area.

5.2 The operation of treatment
5.2.1 Dialysis treatment
Make sure that temp. of dialysate and conductivity is within the normal range before
hemodialysis treatment on patients
Every parameters should be set up before the dialysis treatment (refer to 4.9)

Stopped Lower Temp alarm Prime rinse menu (stop status).
Press “Treatment” key, the screen will enter

UF Goal
UF Pump into dialysis menu (stop status).
0000 ml
UF Rate TMP Ven Art Heparin Blood pump will stop running at this time.
Bypass

Blood Pump
Blood Pump
Next Page
0220 ml/min
01.01
Connect the artery blood pipe with the patient.

Stopped Lower Temp alarm Dialysis menu.
Press “Bridging” key, blood pump will run
UF Goal
UF Pump according to the set bridging flux, venous line
0000 ml
Heparin
clamp opens and blood begins to circulate.
UF Rate TMP Ven Art

Bypass

Blood Pump
Blood Pump
Next Page
0220 ml/min
01.01
Bridging The current mode on screen displays the info.

Running
of bridging running.

Note:
Under the mode of dialysis and blood returning, entering into bridging
status can avoid system monitor, but need the supervision by people.
Connect the vein pipe with the patient.
Check and adjust the blood level of venous

pot.

Stopped Lower Temp alarm Press “Run” key or if system detect there is
blood passing through blood line, the system will
UF Goal
UF Pump enter into the mode of dialysis.
0000 ml
Heparin
Blood pump, heparin pump and UF pump will
UF Rate TMP Ven Art
0010 ml/h 0097 mmHg -002 mmHg 0000 mmHg run.

Bypass

Blood Pump
Blood Pump
Next Page
0220 ml/min
01.01
Dialysis Prompt Current mode on screen displays the running

Running Spec. of heparin syringe is 20ml
info.
The signal light (green) shine.
Dialysis When the set dialysis time counts down to

Dialysis Time Up
Running
0:00, system will raise alarm voice.
Information displays in the text area.

Dialysis
Dialysis Time Up Press “Bridging” key to return blood into
Stopped
patient’s body.
Press “Start” key, blood pump stops running
and the dialysis treatment finished.
Current mode on screen display dialysis

stopped.
Warning:
When return the blood, take care of supervising not to put air into
patient’s body.
Dialysis
Stopped
Signal error alarm
Lower Temp alarm
During dialysis, if need to change dialyzer,
press “Bypass” key, the dialysate will through the
UF Goal
UF Pump inside machine but not dialyzer .
0000 ml

Bypass

Blood Pump
Blood Pump
Next Page
0220 ml/min
01.01
Note ：
In the bypass mode, dialysis is inefficacy.
Press “Bypass” key, then return to normal

dialysis status.
In the bypass mode, dialysis is inefficacy.

5.2.2 Isolated UF treatment
Isolated UF can be performed directly, or during the course of dialysis treatment according to the
actual demand.
Prime
Stopped Setting menu of working mode.
Work Mode Setting
Be sure to set the UF preset volume and UF
（ Refer
A : B : H2O Worke Mode Disinfect Mode Hot Dis. Mode time before isolated UF treatment to
1:1.225:32.775
1:1.830:34.000
1:1.830:34.000
HD
ISO UF
Citric acid
Peracetic acid
Heat+Citric acid
Heat
4.10.4 ）.
1:2.100:34.000 Press “OK” key.
Acetate
Na + ：A + B = ?
Press “Return” key, screen display set
105 + 35 = 140
selection menu.
Blood Mode
A+B Mode (Needle)
A+B Double

Stopped Lower Temp alarm Press “Treatment” key in priming menu, the
screen will display dialysis menu (stop status).

UF Goal
UF Pump
0000 ml

Bypass

Blood Pump
Blood Pump
Next Page
0220 ml/min
01.01
ISO UF Current mode on screen display Isolated UF

Running
running info.
The set UF time counts down to 0:00, system stops

ISO UF isolated UF and enters into dialysis running status
ISO UF Time Up
Running
automatically. The info of “UF time up” is displayed
in text area.

6 Cleanness
6.1 Introduction
Cleanness includes exterior cleanness and interior cleanness.
Exterior cleanness is the cleanness of the outer part of the Dialysis Machine after treatment.
Interior cleanness includes hot disinfection, disinfection and rinse, that is the cleanness of the
waterway in the Dialysis Machine.
The process of rinse: the system will rinse the waterway of the Dialysis Machine.
The process of hot disinfection: the system will remove the calcium and rinse with hot water to the
waterway of Dialysis Machine.
The process of the disinfection: the system will perform the disinfection and iron-removing to the
waterway of the Dialysis Machine.
Warning:
The system should be undergoing the interior cleanness after the
dialysis treatment.
Note:
If the system is left unused for more than 72 hours, it is proposed to
under go the interior cleanness before use.
Note:
If the Dialysis Machine is left unused as long as 10 minutes after the
process of the cleanness, the system will be power-off automatically.
Note:
Disinfect the Extracorporeal blood circuit; Dialyzer, and Needle before
disposal.

6.2 Exterior cleanness
Every time after the treatment, use the pledget to clean the water and stain on the surface of the
Dialysis Machine with the alcohol or the hypochlorite. Keep the cleanness and the dryness of the
Dialysis Machine. If there is the phenomenon of leaking water or dialysate, it should be cleanup and deal
with as soon as possible.
Do examine the colander web on the connector termly. If with the phenomena of jam, the web should
be cleaned or changed.
6.3 The basic condition to undergo the process of interior cleanness
● The treatment is finished
● The return of blood is finished
● The disinfection liquor is already prepared.

6.4 Interior cleanness
6.4.1 Pipeline connection during the disinfection, hot disinfection and rinse
Pipeline connect -----front view
The mode of disinfection, hot disinfection and

rinse:
A B Put solution A adaptor(red) of A concentration
absorbing tube into A adaptor seat and lock it by
circumvolving.
Put solution B adaptor (blue) of B
concentration absorbing tube into B adaptor seat
and lock it by circumvolving.
Pipeline connect----right-side diagram
The mode of the disinfection, hot disinfection

and rinse:
Connect blue fast adaptor cover of dialysate
supply tube to supply tube adaptor (blue);
Connect red fast adaptor cover of dialysate
return tube to return tube adaptor (red).
Not: cannot connect in opposite way.

The Pipeline connects—rear view
The mode of disinfection, hot disinfection and

rinse:
Put the rapid connector of connecting pipeline

to meet the pipe connector, the input pipe of the
RO water should be connected to the supply
So D
is
lu
ti in system of the RO water.
on fe
ct
io
n
connect RO water
supply system
Put the suck-pipe of disinfection solution into

the corresponding container when system
undergoes disinfection and hot disinfection.
Warning:
In the process of interior cleanness, make sure that there is enough
disinfection liquor in the disinfection container to undergo the disinfection
process.

6.4.2 Operation
6.4.2.1 Operation of disinfection
Disinfection solution tube connect drawing
A B
S
o D
l i
u s
i
t
i n
o f
n e
c
t
i
o
n

Stopped Lower Temp alarm Dialysis treatment finished.
（
Dialysis menu stop status ）.
UF Goal
UF Pump Press “Return” key, the screen will return to
0000 ml
Heparin
display prime rinse menu (stop status).
UF Rate TMP Ven Art

Bypass

Blood Pump
Blood Pump
Next Page
0220 ml/min
01.01


Stopped Lower Temp alarm Prime rinse menu (stop status).
Press “Disinfect” key to display cleanness

UF Goal
UF Pump menu (stop status).
0000 ml

Bypass

Blood Pump
Blood Pump
Next Page
0220 ml/min
01.01
Disinfection
Stopped Cleanness menu.
Press “Disinfect” key, and according to
According to suggestion, do operation on suction tubes of liquid(A) and
machine instructions.
600 400 300 liquid(B)
500 300 250
15 Rinse time is 10 mins
14.5

200 0 100
Not allowed to return to other modes if the disinfection or hot
13.5
100 -100 50 disinfection has not been completed
0 -200 0
12.5
-100 -300 -50
06.01

Disinfection
Stopped Confirm disinfection mode, system will start to
undergo disinfection process.
Cond. Time Left Time Left
30.0 ℃
600 400 300
15.5 00.1 mS/cm 0:44
500 300 250
15
400 200 200
14.5 Confirm
300 100 150
Disinfection selected: Citric acid
14
200 0 100 Press 'ok' to continue
13.5 ? Press 'cancel' to re-select, change mode
100 -100 50
13
0 -200 0 OK Cancel
12.5
-100 -300 -50
06.01
Disinfection
Stopped Disinfection program menu.
Current mode displays disinfection running

Cond. Time Left Time Left info.
30.0 ℃
600 400 300
15.5 00.1 mS/cm 0:36
300 250
500
15
Work time of disinfection process refers to
400 200 200
14.5
300 100 150 appendix.
14
200 0 100
100 -100 50
13.5 The menu displays the conductivity, remained
13 Rinse Disinfect
0 -200 0
12.5
1%
1% time and temperature in disinfect.
-100 -300 -50
When time counts down to 0:00, disinfection
Rinse Disinfect Hot Dis. Return
06.01
MON 15:03 finished and alarm voice raised.
Screen returns to display cleanness menu
(stop status).
“Disinfection time out” info. will display in text

area.
Disinfection The disinfect program can be stopped via
Disinfection Time Up
Stopped
pressing “Disinfect” key in disinfect.

6.4.2.2 Operation of hot disinfection
Disinfection solution tube connect drawing
Work time of rinse process is 1 mins, when

the hot disinfection starts.
A B
So D
lu i
s
ti i
n
on f
e
c
t
i
o
n
Disinfection
Press “Hot Dis.” Key, system will start hot
According to suggestion, do operation on suction tubes of liquid(A) and disinfection process.
600 400 300 liquid(B)
500 300 250
14.5

200 0 100
13.5
0 -200 0
12.5
-100 -300 -50
06.01
Disinfection
Stopped Confirm hot disinfection mode, system will
start to undergo disinfection process.
Cond. Time Left Time Left
30.0 ℃
600 400 300
15.5 00.1 mS/cm 0:42
500 300 250
15
400 200 200
14.5 Confirm
300 100 150
Hot Dis. selected: Heat + Citric acid
14
200 0 100 Press 'ok' to continue
13.5
? Press 'cancel' to re-select, change mode
100 -100 50
13
0 -200 0 OK Cancel
12.5
-100 -300 -50
06.01

When temperature rises to be 60 ℃,the time

starts to count down.
Disinfection
Stopped Hot Disinfection process menu.
Current mode displays hot disinfection info.

Cond. Time Left Time Left Work time of hot disinfection process refers to
30.0 ℃
600 400 300
15.5 00.1 mS/cm 0:41
500 300 250
15 appendix.
400 200 200
14.5
300 100 150
14
The menu displays the conductivity, remained
200 0 100
100 -100 50
13.5
time and temperature in hotrinse.
13
0 -200 0 Rinse Hot Disinfect
12.5
-100 -300 -50 1%
06.01
After hot disinfection began, according to

suggestion, do operation on suction tubes of
A B
Liquid B.
S
o D
l i
s
u
t i
i n
f
o
n e
c
t
i
o
n
When time counts down to 0:00, hot

disinfection finished and alarm voice raised.
Screen returns to display cleaness menu
Disinfection
Hot Rinse Time Up (stop status).
Stopped
“Hot disinfection time out” info.will display in

text area.
The hotrinse program can be stopped via
pressing “Hot Dis.” key in hotrinse.

Warning:
It maybe damage this device if using the improper disinfection
solution (concentration).

6.4.2.3 Operation of rinse
The elevation of tube connection when the rinse starts
A B
Disinfection
Press “Rinse” key, system starts to undergo
According to suggestion, do operation on suction tubes of liquid(A) and rinse process.
600 400 300 liquid(B)
500 300 250
14.5

200 0 100
13.5
0 -200 0
12.5
-100 -300 -50
06.01

Disinfection
Stopped Rinse process menu.
Current mode displays rinse info.

Cond. Time Left Time Left Work time of rinse process is 10 mins.
28.1 ℃
600 400 300
15.5 00.1 mS/cm 0:09
500 300 250
15
Press “Return” key to stop rinse process and
400 200 200
14.5
300 100 150 return to cleanness menu (stop status).
14
200 0 100
100 -100 50
13.5 The menu displays the conductivity, remained
13 Rinse
0 -200 0
12.5 1%
time and temperature in rinse.
-100 -300 -50
When time counts down to 0:00, rinse finished
Rinse Disinfect Hot Dis. Return
06.01
MON 15:03 and alarm voice raised.
Screen returns to display cleanness menu
(stop status).
Disinfection “Rinse time out” info. will display in text area .
Rinse Time Up
Stopped
The rinse program can be stopped via
pressing “Rinse” key in rinse.

7 Alarms show and the disposal of unusual thing
7.1 Alarms show
Status indicator shines red.
Dialysis
Running
Air bubble alarm Alarm info. displays in text area.
TMP. A.P. V.P. Battery Blood Leak Blood Level Air Bubble Heparin Clogging Temp. Cond.
Such as: Air bubble alarm.
Corresponding alarm indicator shines red and
send off voice alarm.
Note:
The sound pressure range of the auditory alarm signal: 0 ~ 65DB, the volume of
sound for high-priority alarm and medium priority alarm is same.
Note:
Suspending time for sound or alarm 100s ：。
Note:
The record remains at the power failure of alarm system(mains and
build-in power).
Note:
The factory setting will restored at the time the machine is restarted.
Note:
Spare batteries will work at the main power failure, and during which
the alarm settings will not change.

Note:
Power is restored to the alarm system after it has experienced a total
loss of power (supply mains and/or internal electrical power source)
beyond the time that it automatically restores the alarm settings.
Note:
A hazard can exist if different alarm presets are used for the same or
similar equipment in any single area, e.g. an intensive care unit or
cardiac operating theatre.
Warning:
The operator should check the present alarm preset before use the
machine for each of patients.
Warning:
The hazards perhaps exist when several machines with different alarm
presets are used at one area at same time .

7.2 The alarm of blood loop
7.2.1 TMP alarm
TMP. A.P. V.P.

TMP Alarm indicator shines red.
Cause:
600 400 300
500 300 250

TMP exceeds alarm limit.
400 200 200
300 100 150
200 0 100
100 -100 50
0 -200 0
-100 -300 -50

mmHg mmHg mmHg
Alarm info. displays in text area.

Dialysis
Upper TMP alarm
Running Such as: Upper TMP alarm.
Send off voice alarm.
Systems continue to run.

7.2.2 A.P. alarm
TMP. A.P. V.P.

A.P. alarm indicator (red) shines.
600 400 300

Cause:
500 300 250
A.P exceeds alarm limit.
400 200 200
300 100 150
200 0 100
100 -100 50
0 -200 0
-100 -300 -50

mmHg mmHg mmHg
Alarm info. displays in the word area.

Dialysis
Lower A.P. alarm
Running i.e.: Lower A.P. alarm.
Send off alarming voice.
Blood pump stops running.
The venous line clamp will stop the blood loop.
Under “Bridging” condition, system will
continue to run even A.P. exceeds alarm limit.
7.2.3 V.P. alarm
TMP. A.P. V.P.

V.P. alarm indicator (red) shines.
600 400 300

Cause:
500 300 250
V.P exceeds alarm limit.
400 200 200
300 100 150
200 0 100
100 -100 50
0 -200 0
-100 -300 -50

mmHg mmHg mmHg

Alarm info. Displays in the word area.

Dialysis
Upper V.P. alarm
Running i.e.: Upper V.P. alarm.
The venous line clamp will stop the blood loop.
continue to run even V.P. exceeds alarm limit.
7.2.4 Blood leakage alarm
Battery Blood Leak Blood Level Air bubble Heparin clogging Blood leakage alarm indicator (red) shines.
Cause:
Blood exists in the dialysate loop.
Blood leakage alarm info. displays in the word

Dialysis
Blood leak alarm
Running area.
The venous line clamp will stop the blood
loop.
continue to run even blood leakage alarm.
7.2.5 Blood level alarm
Battery Blood Leak Blood Level Air bubble Heparin clogging Blood level alarm indicator (red) shines.
Cause:
Blood level in venous pot is below detector
or there are foamed blood.

Blood level alarm info. displays in the word

Dialysis
Blood level alarm
Running area.
loop.
continue to run even blood level alarm.

7.2.6 Alarm of air bubble
Battery Blood Leak Blood Level Air bubble Heparin clogging Air-bubble alarm indicator (red) shines.
Cause:
There is air bubble in blood loop.
Air bubble alarm info. displays in the word

Dialysis
Air bubble alarm
Running area.
loop.
continue to run even air bubble alarm.
7.2.7 Alarm of heparin
The alarm of heparin block
Battery Blood Leak Blood Level Air bubble Heparin clogging The indicator (red) for the alarm of heparin
block will shine.
Cause:
Heparin pump clog.
The info. of “Heparin-pump clog alarm””

Dialysis
Heparin-pump clog alarm
Running displays in word area.
Send off alarm voice.

Alarm of heparin empty
Alarm cause:
Dialysis
Heparin empty alarm
Running No injection solution in heparin syringe.
The info. of “heparin empty alarm” displays in
word area.
Alarm of heparin time up
Alarm cause:
Dialysis
Heparin time up
Running The time of heparin injection counts down to
0:00.
The info. of “heparin time up” displays in word
area.
7.3 The alarm of dialysate loop
7.3.1 The alarm of conductivity
C ond.
Indicator (red) of conductivity alarm shines.
Cause:
15.5
Actual value of conductivity exceeds alarm
15
14. 5
limit.
14
13. 5
13
12. 5
m S /cm

Alarm info. displays in word area.

Dialysis
Upper Conductivity alarm
Running i.e.: Upper Conductivity alarm.
Water way is in the status of bypass work.
7.3.2 Alarm of temp.
Blood Level Air bubble Heparin clogging Temp. Cond. Indicator (red) of temp. alarm shines.
Cause:
Actual temp. of dialysate exceeds alarm
limit.
Alarm info. Displays in word area.

Dialysis
Upper Temp alarm
Running i.e.: Upper temp alarm.
Over-heat limit
Dialysis
Overheat alarm Alarm cause:
Running
Actual temp. of dialysate is abouve 41.
Time Left Temp
3:00 41.5 ℃ Over-heat alarm info. Displays in word area.

Current temp. displays on temp. screen.
Na+ Concentration
140 mmol/l Adjust Send off alarming voice.

7.4 Power failure alarm
Battery alarm info. displays in text area.

Power off alarm
Generate audio alarm.

7.5 Battery alarm
Battery Blood Leak Blood Level Air bubble Heparin clogging The signal light (red) for battery alarm shine.
Cause:
The storage battery inside machine is not
sufficient to support one minute’s alarm.
Dialysis
Battery alarm info. displays in text area.
Lower battery alarm
Stopped
Generate audio alarm.
7.6 Warning/notice
Warning/notice show
Dialysis
The info. of warning/notice or the relative
Connect Supply tube to machine
Stopped
content display in the text area.
i.e.: Connect Supply tube to machine.
Generate auto alarm.
The signal light (red) shine.

7.7 Disposal of unusual thing
7.7.1 The disposal principle for the unusual thing of Dialysis Machine
Before the dialysis:

1. If there is malfunction when start the Dialysis Machine, restart the device to examine and check.
2. If there is the malfunction about the conductivity, perform the “rinse” in the allowed short time, then
examine and check.
3. If the Dialysis Machine can’t resume, please transfer the dialysis patient to another good Dialysis
Machine to receive the treatment.
4. Don’t use the device to do any dialysis treatment before it is repaired.
During the dialysis:

1. If there exists the warning voice which will not affect the patient’s safety and can be solved at spot,
after the warning voice, it is ok to do the dialysis treatment for the patient. After the treatment,
examine and check it at length.
2. If the warning voice can’t be eliminated at once, do reinput the blood to the patient’s body and pause
the treatment, then undergo the examination and check. If it is resumed, continue the treatment,
otherwise change the Dialysis Machine or continue the treatment after the device is resumed.
3. During the treatment of dialysis, if there is malfunction that it is impossible to use the dialysis device
to return the blood for the patient, do turn the spanner on clockwise by hand to make the blood
transport to the patient. Continue the treatment after the device is resumed or change another
device.
4. When reverse ultra-filtration occurs during dialysis treatment, the water may enter into patient’s
body and cause the increase of the blood pressure and body weight, then it should increase the
blood flow or the volume of ultra-filtration, which may increase the TMP to the ordinary range.

7.7.2 The disposal of unusual things of Dialysis Machine
7.7.2.1 The disposal of warning
Note:
With the alarm voice, press the key of “alarm mute” to eliminate the
warning voice, but the warning indicator and warning words will still
display on the screen. At this time, operator should inspect the
parameter of protection system which the alarming is cancelled.
Warning:
If the device can’t be resumed by the outer adjustment, do report to
the Engineers to repair the device.
Spot disposal: See Appendix B

Maintenance disposal
Note:
The following is for maintenance engineer’s reference.
Alarm info. Possible causes solutions

Temp. of inflow
Priming System will adjust automatically, if not, it should be
increasing or
mode checked further
reducing suddenly
Overheat
Dialysis Heating Temp. is out
alarm Check the temp. detector of heater is good or not
mode of control
Rinse Temp. detector of
Check the temp. detector of outlet is good or not
mode outlet is out of work
Ask for professional personnel to solve the
Water Sampling board of water way is
problem. Non-professional person is not allowed to
sampling error not good
disassemble it
UF outlet valve is damaged Change the UF outlet valve
Outlet of UF
valve of waste water outlet is
pump blocked Change another valve
damaged
Pump A didn’t
Pump A error problem. Non-professional person is not allowed to
run
disassemble it
Pump B didn’t
Pump B error problem. Non-professional person is not allowed to
run
disassemble it
UF Pump
UF pump error problem. Non-professional person is not allowed to
didn’t run
disassemble it
Communicaton There are sth wrong with the Ask for professional personnel to solve the
error for connection between main problem. Non-professional person is not allowed to
host-computer board and waterway board disassemble it
and water way

7.7.2.2 The disposal of unusual things for the main parts
Warning:
If the Dialysis Machine can’t be resumed to normal status by exterior
adjustment, please inform maintenance engineer.
Unusual
Unusual status The way to check and solve
part
The device can’t start in 1.Check the main switch is on or not
Power
normal way
supply 2.Check the pin with board connect well or not
During the treatment, suddenly
system
no signal of power supplym 3.Check the fuse burn out or not
The ball bearing of rotor didn’t
run 1.Check the cover of blood pump is closed correctly
Unusual voice during the or not
The pump running
2.Check the pressure of ball bearing is good or not
of blood The speed is too fast or too
slow compared to other 3.Check the blood pipe diameter is the same as the
machines, and still can’t be set one
adjusted
The pressure of vein is
fixed( normally it will fluctuate
1.Check the VP detection pipe is clamped or not
a little)
VP
No vein pressure value 2.Check if the VP detection pipe is installed correctly
detection
When there is unusual things
system 3.Check if there is air leaking, if necessary, change
for the vein pressure, no
the blood loop pipe or pressure detection pipe
warning voice to remind the
operator
Venous line clamp can’t
pinned Check the venous clamp is lubricated or not, if
Venous
Venous line clamp can’t draw necessary put in some better lubricater which has
line clamp
back automatically after stronger heat resistance
clamping
Dry Can not open
powder Check if there is lock in Dry powder frame
frame Can’t draw back

8 Maintenance and storage
8.1 Termly check the device whether the supply of water (such as the water purify unit) and electricity
(such as the manostat) is good or not. And check whether those devices work properly or not, the
voltage is stable or not. For the area which the voltage is always higher or lower, it is better to use
the automatic manostat.
8.2 Check the precision of the ultrafiltration per half a year or a year, have a look of the operation 4.10
for reference.
8.3 Termly check the filtration web in the Dialysis Machine, it there exists the situation of blocks, clear
up or change it in time.
Note:
After clearing up or changing the web, take care of the airproof when
installing to avoid the connector of web will leak air.
8.4 If with the built-in power supply, the user should charge the battery according to following ways
when they use the device for the first time:
Connect the Dialysis Machine with the electricity source system by the electricity wire.
Connect with the electricity source, the device should be charged for about 20 hours.
If the device have not used for a long time, repeat the process every 6 months.
8.5 The device can’t be impacted to avoid the damage to the parts in it.
8.6 The device should be put upright in the house with the relative humidity not more than 80%, no
causticity, and good ventilation.
Storage Temp.
without antifreeze: 5℃～40℃

with antifreeze: -10℃～40℃
8.7 This device has the guarantee of “return, replace and repair” for one year,please read the
guarantee card for reference.

8.8 Dialysis machine over period of use must be disinfected before use it. Replaced parts must be
disinfected before disposal, and comply with disposal regulations of the countries in the region.

8.9 the spare parts can be used only when they meet requirements of 93/42/EEC(MDD).
Note:
Do not place the dialysis machine somewhere around the high-power motor, high
power radio transmitting equipment, induction heating equipment, high frequency
welding machines, X-ray machines, high-frequency physiotherapy equipment,
automobiles, internal combustion engine ignition system and other sources of
electromagnetic interference, to avoid electromagnetic interference.
Note:
Do not share the one power cord with another high-power equipment.
Note:
The dialysis machine is placed in the ground; the wheel brakes of the
hemodialysis machine must be pressed.
Note:
Please dialysis machine is placed on level ground; Do move dialysis
machine in the bumpy ground.

9 Instruction for device
9.1 Instruction of blood-pressure meter
Diagram of blood pressure monitoring
power switch
display
screen
start switch
When measure BP, first connect the air tube

plug of arm belt with the BP interface which is on
the left side of HD device (refer to 4.1 chart),
wraps the belt on your arm tightly.
Press “ON/OFF” button, the initial display

mmHg ON/OFF shows in the left diagram.
kPa
Start
When appears, you can start the

mmHg
measurement.
kPa

Press “Start” button ，air pump will run and

ON/OFF increase pressure automatically.
Note: remove your hands from the button
Start
within 3 sec after touch the button.
When pressure is up to about 170mmHg
（22.5kPa, air pump will stop automatically.
When stop measuring, press on/off button,
pressure increasing will stop automatically, air
drains and power is off.
Start to measure automatically, flashes

mmHg when pulse inspection starts.
kPa
Note: Don’t shake your arm and air tube
during measurement.
Symbol flashes after finish the

mmHg measurement, the air in arm belt will drain
kPa
automatically.

When measurement finishes, the H-BP and

mmHg L-BP value displays by mmHg, then change to
kPa the value by kPa .BP value and pulse times will
BP value display alternate to show on display.
(about 3.5 secds ）
mmHg
kPa
mmHg
kPa
Pulse times display

(about 2secds）
After finish the BP measurement, press

“ON/OFF” button to turn off power, if you forget
to press the power button, it will turn off
automatically after 5 mins.

Troubleshooting of blood pressure meter
Abnormal display Cause Settlement method
Confirm symbol ， keep your arm and

body immovably, try again.
When EE symbol occurs again, press the BP
insufficient pressure
button continuously, increase the pressure over
30 ～ 38mmHg （ 4 ～ 5kPa ） than the preset
highest BP value.
arm or body moved or

talking during measurement
Confirm symbol ， keep your arm and

body immovably, try again.
press the button
continuously to increase
the pressure up to over
（
45kPa 300mmHg ）
Abnormal status Checking Settlement

No pressure Does the plug of air tube connect Connect the air tube with HD device
increasing the HD device correctly? correctly
Insert the plug of air tube into the
Is the plug of air tube loosened?
connector, be sure to connect them well
EE mark displays:
Air leadage on the arm belt? Replace a new arm belt
can’t measure
Does arm move during increasing After press the ON/OFF button, keep
pressure? still during measurement
Is the arm belt wrapped well? Wrap the arm belt correctly
E mark displays:
Talking during the measurement?
can’t measure or Keep still during measurement
arm moved?
the BP value is too
Take off the clothes which oppress the
high ( low) Did clothes oppress the arm?
arm then measure again.
Others Press ON/OFF button, try again.

9.2 Instruction of back-up power supply
Self-test After starting dialysis device, system will

charge for spare power supply automatically
(capacitance is enough if battery display three
cases).
Dialysis
In the power cut status, system can start
Power off alarm
Running
spare power supply automatically, battery
displays surplus capacity.
Dialysis Lower battery alarm

It will alarm when the battery is no capacity.
Running
Character area display battery capacity
which is shortage.
Note:
At the main power failure, the sapre power can work for over 15min.

Appendix A：Disinfection and Hot Disinfection
Default
Disinfection
Cycling
Pre-rinse Post-rinse Total Disinfection
Working Mode Concentrate Time
Time Time Time temperature
（Include
absorbing
time）
Disinfection
citric acid 20% 1 min. 20 min. 15 min. 36 min. ≥60 ℃
Mode peracetic Without
3.5% 1 min. 15 min. 15 min. 31 min.
acid heating
heat+citric
acid
20% 1 min. 26 min. 15 min. 42 min. ≥80 ℃
Hot Dis.
℃
Mode
heat / 1 min. 26 min. 5 min. 32 min. ≥80
Introduction ：
In normal condition, all the Pre-rinse Time in every model should be 1min. While if the water
conductivity is higher, time maybe extended till the conductivity is reduced.
Disinfection Mode—> citric acid: it can disinfect the machine and remove the calcium.
Disinfection Mode—> peracetic acid: it can disinfect the machine.
Hot Dis. Mode—> heat + citric acid: it can disinfect the machine and remove calcium. In this mode,
the time of heating water till 60 ℃ is not included in both cycling disinfection time and Total Time.
Hot Disi. Mode—> heat: It can disinfect the machine. In this mode, the time of heating water till 60 ℃
is not included in both cycling disinfection time and Total Time.

Appendix B
Description of possible alarm conditions
In the table below the following abbreviations are applied:

PRI means Priority; A-D means alarm delay; PHY means physiological alarm; P-R means pre-rinse; DIA means dialysis;
ISO means Isolated UF; RIN means rinse; DISI means disinfection; H-DIS means heat disinfection.)
（s）
）
H-DIS
Alarm Potential latch
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
Alarm sequence Alarm condition Alarm preset Solutions
types causes or not
Injector of
Send 50 pulses heparin pump is Clear out
to heparin pump blocked.
Heparin stepping motor, Blood circuit
<390
M No / √ √ / / / Priority：consistent 0 or over 7. Clear out ×

obstruction the received tube is clotted.
pulses are 0 or Injector is Get out the
over 7. pushed to the injector and
low end. replace it.
Canister of A
Supply A
concentrate is
concentrate.
The liquid is not The liquid is not empty.
A
detected by detected by Supply tube of A Put the supply
concentrate M 4 No / √ / / / / Priority：consistent ×
floater in A floater in A concentrate is tube of A
is out
concentrate. concentrate. not in the concentrate in
canister of A the canister of
concentrate. A concentrate.

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
After A
After pre-rinse,
concentrate
alarm takes
A connected with Wrong Mixing
place when Replace A
concentrate M 4 No / √ / / / / Priority：consistent reverse osmosis ratio of A ×
conductivity is concentrate.
error water, concentrate.
over 0.6 and
conductivity is too
below 7mS.
high or too low.
The alarm for
Under the mode
disinfection
of disinfection or
liquid error takes Mixing ratio of A
disinfection heating Replace A
M 4 No / / / / √ √ Priority：consistent place when concentrate is ×
liquid error disinfection, concentrate
conductivity is error.
conductivity is too
not in the range
high or too low.
of 0.5～5mS.
please Put the
The canister of The canister of
connect A connector of A
Supply tube of A concentrate is concentrate is
concentrate concentrate
M 4 No / √ / / / / Priority：consistent concentrate is not fitted in A not fitted in A ×
tube to (red) in the
detected. concentrate concentrate
supplying canister of A
circuit. circuit.
canister concentrate.

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
The connector The connector

Connect the
Please (red) of A (red) of A
connector
connect A Supply tube of A concentrate is concentrate is
(red) of A
concentrate M 4 No / / / √ √ √ Priority：consistent concentrate is not neither neither ×
concentrate in
tube to detected. connected to the connected to the
the socket and
Machine. socket nor socket nor
lock it.
locked. locked.
The connector The connector
Connect the
Please (blue) of B (blue) of B
connector
connect B Supply tube of B concentrate is concentrate is
(blue) of B
concentrate M 4 No / / / √ √ √ Priority：consistent concentrate is not neither neither ×
concentrate in
tube to detected. connected to the connected to the
the socket and
Machine. socket nor socket nor
lock it.
locked. locked.
Please
The circuit of B The circuit of B Connect the
connect B
Supply tube of B concentrate is concentrate is circuit of B
concentrate
M 4 No / √ / / / / Priority：consistent concentrate is not not connected to not connected to concentrate to ×
tube to
detected. the cartridge of the cartridge of the bottle of B
supplying
B concentrate. B concentrate. concentrate.
cartridge

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
In the case of In the case of

disinfection or disinfection or Connect the B
Please
heating heating concentrat
connect B
Supply tube of B disinfection, the disinfection, the e tube to
concentrate
M 4 No / / / / √ √ Priority：consistent concentrate is not B concentrate B concentrate the bottle ×
tube to
detected. tube is not tube is not of B
disinfection
connected to theconnected to the concentrat
bottle
bottle of
bottle of e.
disinfection. disinfection.
Connect the
supply tube
Please (blue) to the
The The
connect the The supply/return down-end of
supply/return supply/return
supply/ tube is not machine,
M 4 No / √ √ / / / Priority：consistent tube is not turn is not ×
return tube detected by the connect the
connected to the connected to the
to the machine. return tube
machine. machine.
dialyzer. (red) to the
up-end of
machine.

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
Connect the
supply tube
Please (blue) to the
The The
connect the The supply/return down-end of
supply/return supply/return
supply/retur tube is not machine;
M 4 No / / / √ √ √ Priority：consistent tube is not turn is not ×
n tube to detected by the connect the
connected to the connected to the
the machine. return tube
machine. machine.
Machine. (red) to the
up-end of
machine.
Please Dry powder Dry powder
Dry powder frame Draw back dry
draw back frames are not frames are not
M <1 No / √ / √ √ √ Priority：consistent are not detected powder ×
dry powder drawn back by drawn back by
by machine. frames.
frames machine. machine.
Please Dry powder Dry powder
Dry powder frame Release dry
release dry frames are not frames are not
M <1 No / √ / / / / Priority：consistent are not detected powder ×
powder drawn back by drawn back by
by machine. frames.
frame machine. machine.
Conductivity and Conductivity and Conductivity and
Pre-rinse is temperature temperature temperature Machine can
M 4 No √ / / / / / Priority：consistent ×
done reach the set reach the set reach the set work normally.
value. value. value.

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
Dialysis liquid
temperature is Reset the
over set range range of alarm.
by user.
Confirm
Up-end limit
Temperature is temperature of
of
M 2 No / √ / / / / Priority：consistent over the set up Last set value. Temperature of reverse ×
temperature
limit. reverse osmosis osmosis water
alarm.
water is too high. is in the
specified
range.
Transducer is Replace the
broken. machine.
Dialysis liquid
temperature is Reset the
over set range range of alarm.
by user.
Down-end
Temperature is Confirm
limit of
M 2 No / √ / / / / Priority：consistent below the set Last set value. temperature of ×
temperature
down-limit. Temperature of reverse
alarm.
reverse osmosis osmosis water
water is too low. is in the
specified
range.

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
Transducer is Replace the

broken. machine.
Blood flow is too
Reduce the
small, and UF
volume of UF
volume is too
pump.
Alarm for big.
upper limit Blood tube is
Trans-membrane Clear out
of clotted.
M 2 No / √ √ / / / Priority：consistent pressure is over >360mmHg ×
trans-memb Change into
its upper limit. UF coefficient of
rane dialyzer with
dialyzer is too
pressure higher UF
small.
coefficient.
Dialyzer is Replace
clotted. dialyzer.
Reduce the
Alarm for Blood flow is too
volume of
lower limit big.
Trans-membrane blood pump.
of
M 2 No / √ √ / / / Priority：consistent pressure is below <40mmHg Change into ×
trans-memb UF coefficient of
its lower limit. dialyzer with
rane dialyzer is too
smaller UF
pressure high.
coefficient.
Alarm for Conductivity is Conductivity of A
Replace A or B
conductivity M 2 No / √ / / / / Priority：consistent over the upper >145 ms/cm or B concentrate ×
concentrate.
upper limit limit. is not eligible.

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
Reverse Increase
osmosis water is reverse
not sufficient osmosis water
Wrong set of
Reset the
conductivity
upper/lower
upper/lower
limits.
limits.
Replace
Machine failure.
machine.
Conductivity of A
Replace A or B
or B concentrate
concentrate.
is not eligible.
Wrong set of
Reset the
conductivity
upper/lower
Alarm for Conductivity is upper/lower ×
limit
conductivity M 2 No / √ / / / / Priority：consistent below the lower <135ms/cm limits.
lower limit limit. Check the
Leakage of
connectors,
Dialyzer
and replace if
connectors.
needed.
Replace
Machine failure.
machine.

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
Feedback pulses Feedback pulses

Blood pump
are over/below are over/below Blood pump is Replace
is out of M <50 No / √ √ / / / Priority：consistent ×
the upper/lower the upper/lower out of control. machine.
control
limit. limit.
Feedback pulses Feedback pulses
spare pump
are over/below are over/below Spare pump is Replace
<50
is out of M No / √ √ / / / Priority：consistent ×
the upper/lower the upper/lower out of control. machine.
control
limit. limit.
Main power is
Battery Main power is
cut, and
capacity is cut, and machine Battery capacity Replace
M <1 No √ √ √ √ √ √ Priority：consistent machine working ×
not working time is is not sufficient machine.
time is less than
sufficient less than 1 min.
1 min.
Try to finalize
the treatment
Alarm for Main power cut, on the
main power M <1 No √ √ √ √ √ √ Priority：consistent Main power cut Main power cut the battery machine ×
cut works. ASAP, and
then replace
the machine.
Adjust the
Liquid level of Liquid level of
Under dialysis of Liquid level of liquid level of
Alarm for venous chamber venous chamber
<0.12
H No / √ √ / / / ISO UF mode: venous chamber venous √

liquid level is below is below
Priority：3 is too low. chamber, refer
transducer. transducer.
to 5.1.5.

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
The volume of
Under dialysis of There is bubble the bubble is Vent the
Alarm for <0.12 Air inlets into the
H No / √ √ / / / ISO UF mode: more than 200µl more than 200 bubble if √
bubble blood tube.
Priority：4 in blood circuit. µl(at the flow of possible.
200ml/min）
Alarm for The pressure Venous tube is
Clear out
venous Under dialysis of inside venous clotted.
pressure H 4 No / √ √ / / / ISO UF mode: chamber is over >210mmHg Patient’s √
upper Priority：5 the set upper conditions Rescue patient
limit limit. deteriorated
Blood flow is too Increase the
The pressure small flow.
Alarm for
Under dialysis of inside venous Connect the
venous
H 4 No / √ √ / / / ISO UF mode: chamber is below <10mmHg Needle fall off needle to √
pressure
Priority：6 the set lower patient
lower limit
limit. Dialyzer is Replace
clotted. dialyzer.

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
The machine
will
automatically
stop UF, when
Volume of
Volume of UF is Volume of UF is Volume of UF is volume of UF
<0.12
UF is over H No / √ √ / / / Priority：consistent √
over the preset. over the preset. over the preset. is over the
the preset.
preset. If the
increase UF is
needed, reset
the UF.
Dialysis Over the set The set time is Treatment is

<0.12
H No / √ / / / / Priority：consistent Dialysis time is 0 √

time is out time (4:00 hours) out. over.
The set time is

out, the
ISO UF Over the set The set time is
<1.1
H No / / √ / / / Priority：consistent ISO UF time is 0 machine √

time is out time（0:30） out.
switch to
dialysis mode.
When rinse
Rinse time Under the state of Rinse time is time is out, the
<1.1
H No / / / √ / / Rinse time is 0 Rinse time is 0 √

is out rinse，Priority：2 out. water circuit
stops working.

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
When
Under the state of disinfection
Disinfection <1.1 Disinfection time Disinfection time Disinfection time
H No / / / / √ / disinfection time is out, the √
time is out is 0 is 0 is out
，
Priority：2 water circuit
stops working.
When heat
Heat Under the state of disinfection
Heat Disinfection Heat Disinfection Heat Disinfection
<1.1
Disinfection H No / / / / / √ heat disinfection ， time is out, the √

time is 0 time is 0 time is out
time is out Priority：2 water circuit
stops working.
Under the state
of heparin pump Add the
Heparin running, the Over the set ISO ISO UF time is heparin and
<1.1
H No √ √ √ / / / Priority：consistent √
time is out heparin pump UF time （3:30） out. reset the alarm
running time is time.
0.
Red liquid is
The ratio of red
detected by
Under dialysis of cell in water Dialysis
Alarm for sensor of Replace
H 4 No / √ √ / / / ISO UF mode: circuit tube of membrane √
blood leak photocell during dialyzer.
Priority： dialysis liquid is breaks.
the ISO UF or
：2
over 0.32.
dialyzing mode.

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
Alarm for The pressure

Wrong set of the
arterial Under dialysis of inside arterial Reset the
upper/lower limit
pressure H 4 No / √ √ / / / ISO UF mode: chamber is over >200mmHg upper/lower √
of arterial
upper Priority：7 the set upper limit.
pressure.
limit limit.
The end of blood
Check the
tube to artery is
tube.
kinked.
Decrease the
Blood pump
flow of blood
rotates too fast.
pump.
Artery is too
the pressure Adjust the
Alarm for narrow or needle
Under dialysis of inside arterial position of
arterial location is not
H 4 No / √ √ / / / ISO UF mode: chamber is below <-200mmHg needle. √
pressure proper.
Priority：8 the set lower
lower limit Adjust the
limit. Patient’s blood
upper/lower
flow is
limit of artery
insufficient.
pressure.
Wrong set of the Reset the
upper/lower limit upper/lower
of artery limit of artery
pressure. pressure.

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
Hall transducer is Hall transducer

Heparin conducting, is conducting, There is no
Draw the liquid
injector H <8 No √ √ √ / / / Priority：consistent indicating the indicating the heparin in √
with injector.
empty heparin pump is heparin pump is injector.
empty. empty.
Check the
Under dialysis of Reverse
switch of
ISO UF mode ， The floating osmosis water is
The floating reverse
Priority：10; transducer in out.
transducer in osmosis water.
Under the state of heating
Reverse heating chamber 1) Check if the
rinse, disinfection, chamber
osmosis H 4 No √ √ / √ √ √ reaches low end, Reverse equipment √
heat disinfection ， reaches low
water is out. which is osmosis water connect
Priority：4; end, which is
detected by supplying properly;
Under the state of detected by
machine. system work 2) Check if the
pre-rinse，Priority： machine.
abnormally. tube is kinked
2.
or distorted.
The Sampling signal Sampling signal Communication
waterway is not sent to is not sent to between the Replace
H 4 No √ √ √ √ √ √ Priority：consistent √
cannot be water control water control circuit boards is machine.
sampled circuit. circuit. abnormal.
Communica Water control Water control
Communication
tion host chip doesn’t host chip doesn’t
Under all states， between the Replace
between H <4 No √ √ √ √ √ √ communicate communicate √
Priority：1 circuit boards is machine.
host and with water control with water
abnormal.
water circuit board. control board.

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
error
1) dialysis: 1) dialysis:
temperature >41 temperature >41
℃; ℃;
2) pre-rinse: 2) pre-rinse:
temperature>60 temperature>60
Under dialysis of
℃; ℃;
ISO UF mode:
3) disinfection: 3) disinfection:
Priority：9; Temperature of
temperature temperature >99 temperature >99 Replace
H 2 No √ √ / √ √ √ Under the state of water circuit is √
alarm ℃; ℃; machine.
rinse, disinfection, too high.
4) heat 4) heat
heat disinfection ，
disinfection: disinfection:
Priority：3.
℃; ℃;
5) rinse: 5) rinse:
℃. ℃.
Erroe of the Error of the Error of the
pre-dialysis pre-dialysis pre-dialysis
Conductivity is Replace
<840
/post-dialysi H No / √ / / / / Priority：consistent /post-dialysis /post-dialysis √

abnormal. machine.
s conductivity is conductivity is
conductivity over 1.0Ms/cm. over 1.0Ms/cm.

（s）
）
H-DIS
PHY
DISI
ISO
P-R
DIA
RIN
PRI
A-D（
types causes or not
Please Blood pump Blood pump Blood pump

Close the
close the cover is not cover is not cover is not
H <4 No / √ √ / / / Priority：consistent blood pump √
blood pump closed during closed during closed during
cover.
cover dialysis. dialysis. dialysis.
Please Fail to operate Fail to operate
Blood dialysis is Start up the
operate H <4 No / √ √ / / / Priority：consistent blood pump blood pump √
not started up. dialysis.
blood pump during dialysis. during dialysis.
During dialysis,
Supplement During dialysis,
the liquid cannot
ary the liquid cannot
be detected Liquid cannot be Replace
<400
chamber air H No / √ / / / / Priority：consistent be detected even √

even removing supplemented. machine.
removing removing air runs
air runs over 20
error over 20 times.
times.
The pressure of The pressure of 1) Connect
water circuit is water circuit is supply/return
Supply/
not detected not detected Supply/return tube properly;
return tube
<30
H No / / / √ √ √ Priority：consistent during the during the tube connection 2) Disinfect, √

connection
disinfection, disinfection, wrong. rinse or heat
wrong.
rinse, heat rinse, heat disinfect over
disinfection. disinfection. again.

The color of indicator:
Color of Flicker
Alarm type Duty Cycle
indicator frequency
High Priority red 1.6Hz 50%
Medium Priority yellow 0.5 Hz 50%

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AMI 11 Dialysis Machine User’s Manual

For AMI 11 Dialysis Machine

Allmed Medical GmbH

Issue date: 01-March- 2012

DFU.017 T026 Page 1 of 145 Rev.01 01-March-2012

1 Safety guidelines ...................................................................................................................... 7

4.10.10 Priming menu ............................................................................................................. 77

7.2.7 Alarm of heparin ...........................................................................................................113

DFU.017 T026 Page 4 of 145 Rev.01 01-March-2012

DFU.017 T026 Page 5 of 145 Rev.01 01-March-2012

Anti-shock protection degree: Type B

Name and address of the Manufacturer

Handle with care

Consult Instructions For Use

DFU.017 T026 Page 6 of 145 Rev.01 01-March-2012

AMI 11 Dialysis Machine User’s Manual (AMI 11)

1.1 Requirements on the operator

1.2 Safety notices

1.4 Contradiction: uncontrollable coagulation abnormality.

DFU.017 T026 Page 7 of 145 Rev.01 01-March-2012

DFU.017 T026 Page 8 of 145 Rev.01 01-March-2012

2.1 Intended Use

2.2 Indications and contraindications

(2) Chronic renal failure

The following conditions are relative contraindications:

The explanations about other situations

(2) Other Diseases

DFU.017 T026 Page 9 of 145 Rev.01 01-March-2012

a. severe water, electrolyte and acid-base balance disorders, using general

therapy is difficult to take effect;

b. hepatic coma and hepatorenal syndrome;

c. hepatic cirrhosis and refractory ascites;

2.3 Introductions on the HD device

2.4 Main technical specifications

Dimension: Height: About 149.4 cm (Fluid stand is not included)

Width: About 55.5 cm

Length: About 35.9 cm (Foot is not included)

Area: About （56.3×62.5） cm2

Electric shock resistance type: Category I

Electric shock protection degree: Type B Symbol:

Liquid incursion protection: Anti-dripping Symbol: IPX1

Work system: Interim loading continuous running

Line voltage: AC220V, Frequency 50/60Hz

Input power: 1700VA

Main switch: C65N 32A AC250V

Flow-in water pressure: 0.12 MPa～0.6 MPa (Standard)

0 MPa～0.6 MPa (Options)

Flow-in water temperature: 5°C～30°C

Drainage: 0～100cm higher than the ground surface

Concentrate supply: Maximum suction height of 75 cm

temporarily stops working. And hotrinse the device before the

device resumes working.

DFU.017 T026 Page 11 of 145 Rev.01 01-March-2012

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

-10°C～40°C (without using anti-freeze)

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

New alarm can activate mute alarm

HD: Hemodialysis with hydrogen carbonate and acetate

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

Cleaning procedure: Including disinfection, hot-rinse, rinse three modes.

Disinfect mode is divided into “Citric acid” and “Per-acetic acid”.

Hot-rinse mode is divided into “Heat + Citric acid” and “Heat”.

Disinfection: period: See Appendix A

Precision: ± 10 ％（ Flow-in pressure: -26kPa ～ +15kPa,