MX1010-1704E4 - Instructions Manual

INSTRUCTION MANUAL
Original instructions
SINGLE PATIENT DIALYSIS MACHINE
DIAMAX
Nipro Corporation
3-9-3 Honjyo-Nishi, Kita-ku
Osaka 531-8510
JAPAN
Phone +81-6-6372-2331
Nipro Europe N.V.

Weihoek 3 H
1930 Zaventem
BELGIUM
Phone +32-2-725-5533
MX1010-1704E4
TABLE OF CONTENTS
1 INTENDED FOR USE AND CONTRAINDICATION ............................................................. 1-1

1.1 Intended Purpose of This Machine .................................................................................1-1
1.2 Contraindication...............................................................................................................1-1
2 RISKS AND BENEFITS OF MEDICAL SOLUTIONS ...........................................................2-1

2.1 Benefits ............................................................................................................................2-1
2.2 Risk ..................................................................................................................................2-1
3 PRECAUTIONS ......................................................................................................................3-1
3.1 Equipment Classification and Handling precautions .......................................................3-1
3.2 Precaution for Fluid Penetration ......................................................................................3-1
3.3 Precaution for Flammable Atmospheres .........................................................................3-1
3.4 Safety Precautions ..........................................................................................................3-1
●DANGER ....................................................................................................................................3-3
●WARNING ..................................................................................................................................3-5
●CAUTION ...................................................................................................................................3-7
3.5 Precautions ......................................................................................................................3-9
3.6 Precautions for Software ...............................................................................................3-10
4 TERMINOLOGY .....................................................................................................................4-1
5 MEANINGS OF SYMBOLS AND DISPLAYS .......................................................................5-1
6 INSTALLATION ......................................................................................................................6-1
6.1 Power Supply .................................................................................................................6-1
6.2 Water Supply conditions, Drainage Conditions .............................................................6-1
6.2.1 Water Supply conditions ...................................................................................6-1
6.2.2 Drainage conditions ..........................................................................................6-2
6.2.3 Environment of Usage .......................................................................................6-2
6.3 Surrounding space .........................................................................................................6-2
6.4 Unpacking and Installation ............................................................................................6-4
6.4.1 Unpacking carton and confirmation of accessories ..........................................6-4
6.4.2 Assembling accessories into machine ..............................................................6-5
6.4.3 Assembling disinfectant nozzle holder/disinfectant tray ...................................6-5
6.4.4 Assembling color lamp / I V pole .......................................................................6-8
6.4.5 Wiring for color lamp .........................................................................................6-9
6.5 Releasing hinge at Operation Panel ............................................................................6-10
6.6 Connections to Water Supply Inlet and Drain Outlet ..................................................6-11
6.6.1 Dimensions of connectors at water supply inlet and drain outlet ...................6-11
6.6.2 Connecting the water supply hose ..................................................................6-11
6.6.3 Connection to drain outlet ...............................................................................6-12
6.7 Connecting the Power Plug .........................................................................................6-13
6.8 Water Supply ...............................................................................................................6-13
6.9 Disposal of the Machine ..............................................................................................6-14
6.9.1 Disposal of the main machine .........................................................................6-14
6.9.2 Disposal of LCD display ..................................................................................6-14
6.9.3 Disposal of the backup batteries .....................................................................6-14
7 Specifications........................................................................................................................7-1
7.1 Major Functions ...............................................................................................................7-1
7.2 Disposables and consumptive material .........................................................................7-2
7.2.1 Disposables.........................................................................................................7-2
7.2.2 Consumptive material .......................................................................................7-2
7.3 Electromagnetic Interference .......................................................................................7-3
7.4 Important Documents ..................................................................................................7-3
7.5 Dimensions and Weight ...............................................................................................7-4
7.6 Electrical Safety (Ordered by EN60601-1) ..................................................................7-4
7.7 Electrical Supply ..............................................................................................................7-5
7.8 Fuses ...........................................................................................................................7-5
7.9 External connections ...................................................................................................7-5
7.10 Operating Conditions ...................................................................................................7-6
7.11 Storage and transportation ..............................................................................................7-7
7.12 Hydraulics ....................................................................................................................7-7
7.12.1 Blood Leak Detector ...........................................................................................7-7
7.12.2 Transmembrane Pressure ..................................................................................7-7
7.12.3 Dialysate Pressure ..............................................................................................7-8
7.12.4 Ultrafiltration ........................................................................................................7-8
7.12.5 Degassing ...........................................................................................................7-8
7.12.6 Acetate Dialysis ..................................................................................................7-8
7.12.7 Bicarbonate Dialysis ...........................................................................................7-9
7.12.8 Dialysate Temperature........................................................................................7-9
7.12.9 Dialysate Flow Rate ............................................................................................7-9
7.13 Extra corporeal Blood Circuit .....................................................................................7-10
7.13.1 Arterial Pressure ...............................................................................................7-10
7.13.2 Venous Pressure ..............................................................................................7-10
7.13.3 Air Detector .......................................................................................................7-10
7.13.4 Blood pump .......................................................................................................7-11
7.13.5 Syringe pump ....................................................................................................7-11
7.13.6 Single Needle Single pump ..............................................................................7-12
7.14 Rinse ..........................................................................................................................7-12
7.15 Options .......................................................................................................................7-13
7.15.1 Battery ...............................................................................................................7-13
7.15.2 Dialyzer Inlet Pressure……………………………………………………………..7-13
8 MACHINE OF CONFIGURATION .........................................................................................8-1

8.1 Machine Components .....................................................................................................8-1
8.2 Names and Functions of Machine Components .............................................................8-2
9 CONFIGRATION OF OPERATING SECTION ......................................................................9-1

9.1 Operation Panel...............................................................................................................9-1
9.2 Names and Functions of Operation Panel ......................................................................9-2
9.3 Bloodline Set Panel .........................................................................................................9-3
9.4 Names and Functions of Bloodline Set Panel.................................................................9-4
9.5 Power Supply Section .....................................................................................................9-5
9.6 Names and Functions of Power Supply Section .............................................................9-5
10 ACTIVATION OF ALARM AND ITS RESETTING METHOD..............................................10-1

10.1 Emergency Stop ............................................................................................................10-1
10.2 Operations of the Machine When Abnormality Has Occurred ......................................10-3
10.3 When Alarm goes off .....................................................................................................10-4
10.4 Interpretation of the Alarm and Information Table ........................................................10-5
10.5 Numbers for Alarms and Information ............................................................................10-6
11 DAILY MAINTENANCE .......................................................................................................11-1

11.1 Machine Enclosure ........................................................................................................11-1
11.1.1 Cleaning and disinfection of enclosure .............................................................11-1
11.1.2 Cleaning of dialysate concentrate nozzle and rinse port..................................11-1
11.1.3 Cleaning of the touch panel ..............................................................................11-2
11.2 Cleaning and Disinfection Inside Machine ....................................................................11-2
11.3 Maintenance and Inspection .........................................................................................11-3
12 OPERATION OF MACHINE.................................................................................................12-1
12.1 Operation in Screen.......................................................................................................12-1
12.2 Screen Display Configuration ........................................................................................12-3
12.3 NURSE Mode and TECHNICIAN Mode........................................................................12-5
12.4 Process Flowchart .........................................................................................................12-6
13 RINSING AND DISINFECTING THE SYSTEM ...................................................................13-1

13.1 Recommended Disinfection Method to Machine ..........................................................13-1
13.1.1 Concentration of disinfectant ............................................................................13-1
13.1.2 Diluted concentration and disinfection time ......................................................13-2
13.1.3 Confirmation of residual disinfectant ................................................................13-2
13.2 Removing Calcium from Dialysate Line ........................................................................13-2
13.2.1 Chemical to be used .........................................................................................13-3
13.2.2 Confirmation of residual chemical.....................................................................13-3
13.3 Rinse / Disinfection Process..........................................................................................13-4
14 USING OF THE MACHINE .................................................................................................14-1

14.1 Preparation Before Turning ON Power Supply Breaker .............................................14-1
14.2 Turning ON the Power Supply Breaker .......................................................................14-2
14.3 Dialysis Preparation Process .......................................................................................14-3
14.3.1 Setting of dialysate ..........................................................................................14-3
14.3.2 Preparation of dialysate ..................................................................................14-4
14.3.3 Setting Dialysis operation ...............................................................................14-7
14.3.4 Dialysis preparation process ...........................................................................14-9
14.3.5 Preparation of bloodline and dialyzer .......................................................... 14-11
14.3.6 Priming ......................................................................................................... 14-20
14.3.7 Dialyzer rinse ................................................................................................ 14-22
14.3.8 Confirmation of Dialysate Concentration ...................................................... 14-25
14.4 Connection to the Patient ......................................................................................... 14-26
14.4.1 Procedure of connection to the patient .................................................. 14-26
14.5 Confirmation of TREATMENT DATA ......................................................................... 14-27
14.6 Setting Kt/V ................................................................................................................. 14-29
14.7 Reminder Clock ......................................................................................................... 14-32
14.8 Dialysis Process ....................................................................................................... 14-33
14.9 Completion of Dialysis .............................................................................................. 14-36
14.10 SEQUENTIAL UF (ECUM) Operation ...................................................................... 14-36
14.11 Dialysis End .............................................................................................................. 14-38
14.11.1 Procedure of Dialysis End ............................................................................ 14-38
14.12 RETRANS and OVERRIDE mode ........................................................................... 14-38
14.13 Disconnection of the Dialyzer ................................................................................... 14-40
14.14 Ending Operation ...................................................................................................... 14-41
14.15 Discarding the bloodline and dialyzer ....................................................................... 14-41
14.16 Display of Last Treatment Data .............................................................................. 14-42
14.17 Turning OFF The Power Supply Breaker ............................................................... 14-44
15 SINGLE NEEDLE OPERATION ..........................................................................................15-1

15.1 Selecting single needle (SN) .........................................................................................15-2
15.2 Setting SN parameters ..................................................................................................15-3
15.3 Setting SN pressure alarm ............................................................................................15-4
15.4 Dialysis by SN operation ...............................................................................................15-6
15.4.1 Dialysis operation ..............................................................................................15-6
15.4.2 Screen in dialysis ..............................................................................................15-6
16 REFERENCE MATERIAL ....................................................................................................16-1

16.1 Dialysate Flow Chart .....................................................................................................16-1
16.2 Color lamp state diagram ..............................................................................................16-4
16.3 State of Backup Battery Operation ............................................................................16-6
16.4 Alarm Output at the Start-up process........................................................................16-7
1 INTENDED FOR USE AND CONTRAINDICATION
1.1. Intended Purpose of This Machine
a) Use the single patient dialysis machine DIAMAX when a doctor has prescribed the
hemodialysis for a patient suffering from acute or chronic renal failure.
b) This dialysis machine can be used in a controlled environment such as a place in a
hospital. The standard equipment can perform the following treatment.
- Hemodialysis (Double needle or single needle)
The equipment can be used in both the “acetate” and “bicarbonate” modes. In the
bicarbonate mode, bicarbonate is provided in a container.
- Sequential dialysis (Double needle or single needle)
Performs only ultrafiltration without performing blood dialysis. Sequential dialysis
operation is intended only for UF GOAL in the case that it is incomplete at the end of
treatment. Sequential dialysis is not different from the HF treatment and so not use it
as HF treatment.
c) This machine is capable of providing both the acetate dialysis and the bicarbonate
dialysis treatments.
1.2. Contraindication
a) This dialysis machine is not designed, manufactured, and sold intended for the use other
than the hemodialysis treatment to be provided to a patient suffering from acute or
chronic renal failure.
b) Attention should be paid to contraindications valid for extracorporeal treatment in general.
1-1
2 RISKS AND BENEFITS OF MEDICAL SOLUTIONS
The following comparisons between risks and benefits have been done for the treatments of
hemodialysis for all patients with renal failures.
2.1. Benefits
1. Improvement of uremia
Hemodialysis improves uremic conditions by removing uremic substances represented by
decomposition products of proteins, such as blood urea nitrogen (BUN) and creatinine. Since
hemodialysis also removes the excessive water content of the body and adjusts the amount of
electrolytes and keeps acid-base balance, the patients can regain their health to a fairly normal level.
2. Improvement of anemia
Hemodialysis improves anemic conditions. Furthermore, with using erythropoietin medicine, the
patients can recover from anemia almost completely.
3. Improvement of hypertension
Adequate ultra filtration during hemodialysis improves the conditions of hypertension caused by
the accumulation of sodium and water content in the body.
2.2. Risk
1. Disequilibrium syndrome
Though electrolytes and urea in blood are removed fastly by hemodialysis, those substances in
brain cells are removed slowly. That causes the difference of concentrations between blood and
brain cells and the difference induces the influx of water into brain cells and results in the rise of
brain pressure. This causes the patients general lassitude, headache, nausea, the increase and
reductions of blood pressure, spasm and consciousness disorder.
2. Hypotension during hemodialysis
Rapid or excessive ultra filtration during hemodialysis causes hypotension and results in
oscitation, nausea, vomit, headache, palpitation, sweat and head noises. When the symptom
becomes worse, it causes chest pain, stomachache and consciousness disorder.
3. Angialgia at puncture site
Puncture needle induces the stimulation of vessel wall, the arctation of vessel, the stimulation of
foreign substance in vessel, the symptom of angitis and the contraction of vessel, and those
cause the patients angialgia.
4. Arrhythmia
Hemodialysis may cause arrhythmia during the treatment for patients who have ventricular
hypertrophy or arteriosclerosis.
5. Acceleration of hemorrhage
The use of heparin for the control of blood coagulation accelerates hemorrhage (hemorrhoidal,
menstrual bleeding, nasal bleeding and odontorrhagia).
6. Arteriousclerosis
Uremic toxin, the dysbolism of calcium and phosphorus and the increase of humor are
2-1
considered the accelerators of arteriosclerosis.
7. Anemia
Erythropoietin (EPO), a hematogenous hormone, may cause anemia. Though the improvement
of the symptom is observed in the most of patients by use of EPO medicine, curretly some of
them show an inadequate response to the medicine is observed.
8. Cardiac faiures
The continuation of excessive water content in the body, the myocardial failures induced by
uremic toxins and hypertension cause stress to the heart, and tend to result in cardiac failures.
9. Bone diseases
Secondary hyperparathyroidism, which is caused the dysbolism of calcium and phosphorus and
the lack of vitamin D, induces osteities fibrosa, and results in the dissolution of calcium from
bone. That increases likelihood of bone fractures and causes pais in bones or joints.
10. Amyloidosis
For patients undergoing hemodialysis for a long period, the deposit of amyloid, which has
β2-microglobulin (BMG) as its precursor, disables free movements of hands and fingers, and
causes the failures of bones ad joints, such as carpal-tunnel syndrome, chorioadenoma
destruens and bone cyst, accompanied by acute pains.
11. Infectious diseases
Since the patients on hemodialysis generally have low resistance to infections, their infection
rate tends to be high. Infectious diseases include shunt infection caused by invading microbes at
puncture sites, pneumonia caused by complication of cold, the infection of tubercule bacillus,
and post transfusion hepatitis.
12. Pollution caused by endotoxin in dialysate
As the range of removal targets expands from the substances with small-to-middle molecular
weight, such as urea and creatinine, to those such as β2-microglobulin (BMG), a precursor
protein of amyloid, the trend of dialysis membrane has shifted from normal membrane to highflux
membrane with improved removal performance. As a result, endotoxin is transferred from
dialsate to blood, and that may cause the patients fever and affect their cardiovascular systems.
13. Thrombosis
Thrombosis is the formation of a blood clot inside a blood vessel and a blood tube in dialysis
therapy, obstructing the flow of blood through the circulatory system. When a blood vessel is
injured, the body uses platelets and fibrin to from a blood clot to prevent blood loss. Alternatively,
even when a blood vessel is not injured, blood clots may form in the body if the proper conditions
present themselves. If the clotting is too severe and the clot breaks free, the traveling clot is now
known as an embolus.
14. Thrombembolic
Formation in a blood vessel of a clot that breaks free and is carried by the blood stream to plug
another vessel. The clot may plug a vessel in the lungs (pulmonary embolism), brain (stroke),
gastrointestinal tract, kidneys, or leg. Thromboembolism is an important cause of morbidity
(disease) and mortality (death), especially in adults. Treatment may involve anticoagulants
2-2
(bloodthinners), aspirin, or vasodilators (drugs that relax and widen vessels).
15. Air embolism
An air embolism, or more generally gas embolism, is a pathological condition caused by gas
bubbles in a vascular system. The most common context is a human body, in which case it refers
to gas bubbles in the bloodstream (embolism in a medical context refers to any large moving
mass or defect in the blood stream). Small amounts of air often get into the blood circulation
accidentally during surgery and other medical procedures (for example a bubble entering an
intravenous fluid line), but most of these air emboli enter the veins and are stopped at the lungs,
and thus a venous air embolism that shows any symptoms is very rare.
16. Hypothermia
Hypothermia is a condition in which core temperature drops below that required for normal
metabolism and body functions which is defined as 35.0 °C (95.0 °F). If exposed to cold and the
internal mechanisms are unable to replenish the heat that is being lost, a drop in core
temperature occurs. As body temperature decreases, characteristic symptoms occur such as
shivering and mental confusion. Hypothermia due to rapid transfusion of large amounts of cold
blood can cause arrhythmias or cardiac arrest.
2-3
3 PRECAUTIONS
Service life of this machine is 6 years.
3.1. Equipment Classification and Handling precautions

This machine is classified as follows:
Type of protection from electric shock ····················ClassⅠ
Degree of protection from electric shock ··················Type B
Ensure to have a protective earth connection with the equipped power plug.
Patient is connected to this machine via patient blood and dialysate.
3.2. Precaution for Fluid Penetration

Keep the machine out of water.
3.3. Precaution for Flammable Atmospheres

Do not use this machine in flammable atmospheres.
3.4. Safety Precautions

Appropriate operation and regular maintenance are essential for safer use of this machine.
Carefully read and thoroughly understand the safety precautions described in this manual before
using or servicing this machine.
The operating procedures and precautions described in this manual are effective only when this
machine is used for its intended purposes. Users shall be liable for all deeds and the safety
measures taken when the machine is used in methods other than specified in this manual.
1. Degree of damage to health and property, and its indication (Alert symbols and signal words)
The degree of the foreseeable damage to health and property when the machine is misused
is classified into the following three categories, and each category is expressed by the
following alert symbol and signal word.
3-1
DANGER
Indicates an imminent hazardous situation, which, if the machine is misused, will

result in death or serious injury.
WARNING
Indicates a potentially hazardous situation, which, if the machine is misused, will result
in death or serious injury.
CAUTION
Indicates a potentially hazardous situation, which, if the machine is misused, may

result in minor or moderate injury or property damage.
2. Note and its indication
NOTE
Indicates note sentences. Make reference when operating or servicing the machine.
3-2
DANGER
Before using the machine, be sure to read this manual.

• This machine operates in a safe and reliable manner when operated and serviced as
specified in this manual.
• Carefully read and thoroughly understand this manual before operating this machine.
Incorrect operation may endanger individual person or damage the machine.
• This machine shall be operated by trained and qualified personnel at a hospital under
the supervision by a doctor.
Know the appropriate method to stop this machine immediately.
• Know the method to stop this machine immediately in order to prevent the occurrence
of serious troubles.
• Do not allow non-professionals to operate the machine without proper instructions.
Know the measures to be taken when the machine stops by the troubles.
• Check the condition of the machine and take appropriate measures according to the
instructions in this manual.
Do not touch printed circuit boards, electric wiring, and terminals except when servicing
of the machine.
• Do not touch any electric wiring and terminals not isolated.
• Do not touch any printed circuit boards with wet hands.
• Turn OFF the Power breaker when touching a printed wiring board, electric wiring, or
terminals.
Take special caution on the following foreseeable risk of danger to a patient when
patient’s connection and disconnection to the machine.
• Air must not enter the body of a patient.
• Do not connect a patient to the bloodline before priming.
• Do not connect a patient to the bloodline when rinse program is in progress.
• Take caution to prevent the entry of any harmful virus and bacteria, and chemicals to
the patient.
The venous pressure monitoring cannot prevent the risk of extracorporeal blood loss
completely.
Always check that a patient is appropriately connected to the bloodline. Improper use of
the bloodline may endanger a patient by the blood leak due to the poor connection,
rupture of the blood line due to inappropriate pressure rise, etc.
The narrow passages in the blood circuit such as kinks or too thin cannula may cause the
hemolysis, and the protective system may not detect this hazardous situation.
3-3
The blood clots or ultrasound gel may cause the functional failure of ultrasonic air bubble
detector.
The air may enter into blood circuit at connection point downstream of the air detector
such as single needle application, if pressure are negative.
This machine is not designed to use for patient with central venous catheter.
• If use with the central venous catheter, increase the risk of patient electric shock.
• When use this machine with other electric equipment (both medical and
non-medical equipment), make sure that the touch current and patient leakage
current of the equipment is not over the requirement of CF Type.
Should follow about disinfectant procedure written in this manual.
In the case that use the other procedure, responsible organization should validate the
efficiency and safety to prevent the contamination due to bacteria or virus entering to the
patient blood.
Responsible organization should be responsible for hygienic quality of any delivery

systems.
3-4
WARNING
Do not change any set values during a treatment except a state of emergency.
• Change set values before connecting a patient.
• When making a setting for a function, thoroughly understand the function to use in
advance.
Take caution to keep the power cable off from the floor to prevent an electric shock
due to the wet floor when this machine hydraulic is leaked.
Furnish drainage near this machine.
Contact, qualified maintenance personnel, when the maintenance of the machine is
required.
Do not operate any switches unnecessarily during dialysis treatment.
Do not tilt the machine more than five (5) degrees if something is put on the
disinfectant tank table, hanger, tray, etc.
Do not tilt the machine more than ten (10) degrees. Otherwise, the machine may fall.
Do not put anything on the disinfectant tank table, hanger, tray, etc when moving the
machine.
Do not connect any equipment other than allowed with this machine.
(Total leak current (of this machine and other connected equipment) may exceed the
allowable limit).
Usages other than specified by the manufacturer may cause injury or death of a
patient. The manufacturer will not liable for any troubles including damage to health of
a patient if this machine is operated, serviced, or calibrated in a manner other than
specified by the manufacturer. Only a trained and qualified person must follow the
procedure specified by the manufacturer.
Measure the real dialysate concentration by the Laboratory.
• Confirm the real dialysate concentration is correct, using an osmotic pressure meter,
a conductivity meter, a flame photometer, etc.
• Confirm that the conductivity displayed on the machine is correct.
In the case that fluctuate the dialysate conductivity, the maximum conductivity
difference of Bicarbonate is 14%, the Total (mixed) one is 20% by alarm setting.
Confirm neither disinfectant nor acid fluid remains after rinsing is complete.
• After disinfection by sodium hypochloride or peracetic acid or acid cleaning by acetic
acids is complete, confirm neither disinfectant nor acidic fluid remains in the fluid
supply part and drainage part using test papers or reagent.
3-5
Do not use DIAMAX in an oxygen rich, presence of the flammable anesthetic mixture
with air, oxygen, or nitrous oxide.
• This machine is not intended to use in the special environment such as a hyperbaric
oxygen therapy room, an operation room, MRI room, etc.
3-6
CAUTION
Read and understand the installation procedures in the maintenance manual before
installation.
• Only trained and qualified personnel must install this machine.
Read and understand the instruction manual of options before installation.
• Only trained and qualified personnel must install the options.
Do not give strong force or shock to the display and operation panel.
• Take caution not to give strong force or shock to the display and operation panel
during cleaning the surface.
Sufficient disinfection must be performed before use.
• Rinse the machine more than one hour, when it has not been used for a long term.
• When using the machine that has not been used for a long term without draining
inside of hydraulic, perform disinfection program.
Be sure to always keep the machine clean.
• Wipe off droplets and stains of blood, dialysate, cleaning solution as soon as
possible.
• Perform rinsing and disinfection regularly.
Depends on the machine condition or sequence the machine restricts to accept
specific keys. In such cases, do not operate switches forcedly.
Be sure to use the dialysate concentrate in properly color-coded container. The
dialysate concentrate not contained in a color-coded container cannot be used with
this machine.
Use only disposable products with CE marking.
A person who handles disposable products may touch hepatitis virus or other
infectious medicals. Take extreme caution not to be infected when operating this
machine.
Assure the quality of water, dialysate concentrate, and substitution fluid used for the
machine operation in order to secure performance and safety.
The actual blood flow was reduced by extremely negative pressure in pre-Blood
pump, and it may cause reducing of treatment efficacy.
Responsible organization should select and check any parameter and setting of
protective system.
3-7
NOTE
 Recommend the installation of Emergency power system for interruption of the power
supply.
 The machine had optional batteries is immediately activated the audible alarm at
interruption of power supply. In the case the machine does not have optional batteries,
the audible alarm is not activation.
3-8
3.5. Precautions
1. Allow only skilled personnel to operate the machine.
2. Take caution on the following points when installing the machine.
1) Install at a place where water does not splash on the machine.
2) Install at a place where the machine does not receive adverse effect from the
atmospheric pressure, temperature, humidity, ventilation, sunlight, and atmosphere
that includes dust, salty, sulfur, etc.
3) Take caution on the stability of the machine not to give it inclination, vibration, and
shocks (including the time of transportation).
4) Avoid a storage of chemicals or a place where gases are generated.
5) Pay attention to the frequency, voltage, and permissible current (or power
consumption) of the power supply.
6) Check the state of the power supply (state of the electrical discharge, polarity, etc.).
7) Connect the grounding properly.
3. Take caution on the following points before use of the machine.
1) Check the conditions of switch contacts and verify that the machine operates properly.
2) Confirm the grounding is ensured.
3) Confirm that all the cable connections are correct and safe.
4) Take sufficient caution when using the machine in combination with other machines
since it may obstruct correct operation or cause danger.
5) Verify that there is neither deforming nor discoloration in the appearance and other
features of the machine.
4. Take caution on the following points when use of the machine.
1) Always observe that there is no abnormality in the operation of the machine and with a
patient.
2) If some abnormality was observed with the machine, take appropriate measures
immediately such as stopping the machine in a safe condition for the patient.
3) Do not raise the dialysate pressure above the allowable limit.
4) Take caution a patient does not touch the machine.
5) Do not give any strong vibration to the machine.
6) Do not bring any electromagnetic wave source close to the machine since it may
cause a breakdown or malfunction of the machine.
7) Do not push or lean against the machine, especially, from left or right side of it. It could
lead to overturn which may cause of seriously injured or breakdown.
5. Take caution on the following points after use of the machine.
1) Turn OFF the power supply of the machine to return the machine to the condition
before use according to the specified procedures.
2) Hold the Power plug and do not give excessive force to the power and other cables for
disconnection. Do not pull the cables when disconnection.
3-9
3) Take caution on the following points for the storage of the machine.
a. Keep at a place away from the water splashes on the machine.
b. Keep at a place where the machine does not receive adverse effect from the
atmospheric pressure, temperature, humidity, ventilation, sunlight, and
atmosphere that includes dust, salty, sulfur, etc.
c. Take caution on the stability of the machine not to give it inclination, vibration, and
shocks (including the time of transportation).
d. Avoid storage of chemicals at a place where gases are generated.
4) Always rinse and clean the machine after use.
5) Always keep the filter of the cooling fan clean.
6. If the machine is defected, check the trouble cause, error message and machine
condition on the appropriate display. Contact NIPRO qualified maintenance personnel for
repair without fiddling it by yourself.
7. Do not modify the machine.
8. Maintenance
1) Only qualified maintenance personnel allow to check the machine and its parts
periodically.
2) Confirm that the machine operates properly and safely when operating the machine
that has not been used for a certain period of time.
9. Others
1) Check the dialysate concentration before connecting to the patient use by the osmotic
pressure measurement method and the like.
2) (Concerning the water to dilute the dialysate concentrate:) AAMI standards water is
recommended for the water to dilute the dialysate concentrate used for the chronic
dialysis treatment.
3.6. Precaution for Software

The Version number of manuals is described on the front cover of each document.
These documents are corresponded with this software version. Please check the list below for
compliance with the software version and these documents before usage.
You can check the software version in the start-up screen.
Documents / Version Software Version

Instruction Manual MX1010-1704E4
Ver. 7.40 or later
Maintenance Manual MX2010-1704E*
(NOTE: * mark shows revision number.)
3-10
4 TERMINOLOGY
The following definitions will apply for the meaning of the terminology used in this manual.
1) Dialysis: Hemodialysis treatment in which substances are removed by diffusion
2) Dialysate concentration: The concentration of sodium electrolyte (unit: mEq/L)
included in the dialysate is simply defined as the dialysate concentration. Also, the
simple wording, "concentration" means the dialysate concentration if not specified for
other meaning.
3) Ultrafiltration (UF): Method of treatment to remove excessive body fluid through
dialyzer membrane.
4) Sequential dialysis: Operation to perform UF (ultrafiltration) without flowing
dialysate.
5) Double needle: Method of treatment performed through bloodline with two fistula
needles or catheter inserted in artery and vein independently
6) Single needle (SN): Method of treatment performed through bloodline with one
fistula needle or catheter.
7) Venous pressure: Pressure in the venous side drip chamber. It is measured by
connecting the venous pressure monitor line from the venous drip chamber of the
bloodline to the venous pressure sensor of this machine. In a word, the pressure in
the bloodline from the dialyzer outlet to a patient can be measured. This machine
defines and displays this pressure as the venous pressure.
8) Arterial pressure: Pressure in the arterial side drip chamber. It is measured by
connecting the arterial pressure monitor line from the arterial drip chamber of the
bloodline to the arterial pressure sensor of this machine. In a word, the pressure in
the bloodline from a patient to the dialyzer inlet can be measured. This machine
defines and displays this value as the arterial pressure.
9) "TMP": Abbreviation of “Transmembrane Pressure”; Indicates the difference in
pressure between the bloodline side and the dialysate line side. This machine simply
uses the following method for calculation.
TMP= (Arterial pressure (PG4b) + Venous pressure (PG5))/2 –
(Dialysate inlet side pressure (PG2) + Dialysate outlet side pressure (PG3))/2 +
OFFSET
When it has not the pressure sensor option, TMP is calculated as PG2 = PG3 and
PG4b = PG5
10) Dialysate: Liquid to filter wastes from blood by using osmotic pressure.
11) Bicarbonate: Represents bicarbonate ion or carbonic acid ion. Dialysis method of
using bicarbonate as the alkalization agent is called the bicarbonate dialysis.
12) Acetate: Represents acetic acid. Dialysis method of using acetic acid as the
alkalization agent is called the acetate dialysis.
13) Bloodline: Represents the tube in which blood passes through the extracorporeal
circulation.
14) Dialyzer: Medical equipment used for hemodialysis; Removal of body fluid and
dialysis are performed through this dialyzer.
15) Rinse process: A process to pass water through and drain it from the dialysate line
of the machine for a cleaning purpose.
4-1
16) Disinfection process: A process to disinfect the dialysate line by passing the
appropriately-diluted disinfectant concentrate through and drain it from the dialysate
line of this machine.
17) Rinse program: A function of the machine to complete the target rinse and
disinfection processes automatically by presetting the pattern of the rinse and
disinfection operation such as washing, disinfection, acetic acid rinsing, etc.
18) Preparation: A process to prepare for the dialysis operation of the machine getting
ready for passing the dialysate after the rinse process is complete.
19) Priming: Filling the dialyzer and the bloodline before use with saline solution, etc.
20) Bypass: Short-circuit line for the dialysate, bypassing the dialyzer; Used to
temporarily interrupt the dialysis treatment by switching to this line when the state of
the dialysate becomes improper because of some reasons during the dialysis
treatment.
21) Closed system: The chamber is filled with fresh dialysate first, and the dialysate is
fed with the pump and returns to the room on the opposite side of the same chamber
through the dialyzer. The whole hydraulic line in which the dialysate passes at this
time is called the closed system.
22) Blood pump: A pump to give the blood flow, overcoming the internal resistance of
the dialyzer and the extracorporeal circulation line.
23) Syringe pump: A pump to inject the anticoagulant agent into blood by pushing the
syringe piston containing the agent at a preset speed.
24) Bolus: A function of the syringe pump to immediately inject the anticoagulant agent
only of the preset volume.
25) Conductivity sensor: Measures the conductivity of the dialysate.
26) Temperature sensor: Measures the temperature of necessary sections in the
dialysate line.
27) Air bubble detector: Detects the air bubbles in the venous side bloodline and
prevents the air entry to a patient.
28) Blood leak detector: Detects the blood loss through dialyzer membrane by an
optical method.
29) Venous clamp: Closes the venous bloodline to protect a patient when the machine
detects unsafe condition on extracorporeal circuit.
30) Grounding: Taking ground. Earthing
31) Disinfectant nozzle: A nozzle to be inserted into the container of the cleaning
solution or disinfectant to aspirate the concentrate in the rinse and disinfection
processes.
32) Technician: A person who can operate, service, and repair this dialysis machine.
4-2
5 MEANINGS OF SYMBOLS AND DISPLAYS
Symbols Meaning
Caution, Consult documents
Ingress protection marking:

IPX1 protected against dripping water (IPX1)
Degree of protection against electric shock: Type B
Degree of protection against electric shock: Type BF

(Applied part: Cuff for BPM option)
Read usage instructions
Do not push
Equipotential
Protective earth
Date of manufacture
I ON (Main power)
O OFF (Main power)
Power ON/OFF switch
ON/OFF (Main power) indicator
Battery indicator
MUTE switch
RESET switch
BLOOD PUMP switch
5-1
6 INSTALLATION
Install this machine at a place that satisfies the following installation requirements.
In addition, installation work described in this chapter must be done by qualified persons
who have received the specified training of this machine by the manufacturer.
WARNING
Installation of the machine must be done only by the persons who have received the training of
this machine provided by the manufacturer and sufficiently mastered its skills and experience.
6.1. Power Supply

The following shows the ratings of the power equipment for this machine.
Power supply: AC230V ± 10%, 50/60 Hz

AC110V ± 10%, 50/60 Hz
Power consumption: 2.2 KVA MAX (Heater: 230V 750VA*2)

2.2 KVA MAX (Heater: 110V 1500 VA)
The power equipment must have sufficient capacity enough to operate this machine.
NOTE
The energy consumption in one treatment (Dialysate Flow rate: 500mL/min, Dialysate
temperature: 37°C, Treatment Time: 4h) is approx. 1.8 kWh.
WARNING
The power cable of DIAMAX is not designed to replace or to modify by users or technicians. If
you need replace the cable, please contact the nearest branch or agency.
6.2. Water Supply Conditions, Drainage Conditions

Check the following points for the proper operation of the machine.
6.2.1. Water supply conditions

Water quality: Clean water for dialysis (Quality water must satisfy the requirements
enforced in the hemodialysis system U.S. standard RD5: Article 3.2
(1981))
Inlet pressure: 0.1-0.73 MPa (1.0-7.5 Kgf/cm2)
Volume of water: 1100 mL/min or more
Temperature: 5-30°C (Temperature variation: Below 1°C/min.)
6-1
NOTE
The criterion of water and dialysate concentrate consumption is as below.
- Water rinse (Time: 15 min): 12L
- Dialysis (Dialysate Flow rate: 500mL/min, Time: 4h): A solution is 3.5L, B solution is 4.0L, Water
is 112.5L
6.2.2. Drainage conditions

Drainage volume: 1500 mL/min or more can be drained.
Drainage height: 0-60 cm (Head: 5 cm or more) Distal end of the drain tube must not
contact with the surface of the water in the waste channel.
Drainage tube: Tube can be used less than 3meters long.
NOTE
The maximum temperature of drainage is 85°C at rinse immediately after hot water rinse or Hot
citric acid process.
It is a short time, the drainage temperature is decrease by exchange with water supply.
6.2.3. Environment of Usage

DIAMAX is not designed to use in an oxygen rich, presence of the flammable anesthetic
mixture with air, oxygen, or nitrous oxide.
WARNING
This machine does not intended to use in the special environment such as a hyperbaric oxygen
therapy room, an operation room, MRI room, etc.
6.3. Surrounding Space

Following clearance must be secured against outside dimensions of equipment.
Top clearance: 5 cm or more
Side clearance: 10 cm or more
Rear clearance: 20 cm or more
For ventilation, there must be a ventilation opening of Φ20cm or more, or one of top, side, and
rear must be open to atmosphere.
CAUTION
Do not install the machine in the place which obstruct the power plug operation.
6-2
DANGER
Make sure that the installation environment satisfies the above conditions. An improper
installation environment may cause serious damage to the health of the operator or the patient
as well as machine malfunctions.
CAUTION
This system requires special instruction for EMC. Read and follow the EMC-related information
in the attached document carefully for installation and use.
6-3
6.4. Unpacking and Installation
DANGER
Dropping out of the package can cause serious accident, such as bone fractures. Never open
the package if no one else is present. Handle the system carefully to avoid dropping it.
6.4.1. Unpacking Carton and Confirmation of accessories

Confirm that the following items are included inside the carton after unpacking the carton.
• IV Pole
• Color Lamp
• Disinfectant Tray
• Dialyser Holder
• Hexagonal Wrench (8 mm)
• Instruction Manual
• Disinfectant Nozzle Holder
• Disinfectant Nozzle
• Handle for Pole
• Tray Disinfectant Nozzle
• Cross recessed head screw (2pieces)
• Cable fixture
Instruction Manual Color Lamp
IV Pole
Dialyzer Holder
Handle for Pole
Cross recessed
head screw
Disinfectant Nozzle Holder
Hexagonal Wrench
Cable fixture
Disinfectant Tray
Tray
6-4
6.4.2. Assembling accessories into machine
Following tools need to be prepared to assemble accessories into the machine.
• Phillips-head screwdriver
• Spanner (26 mm)
CAUTION
Note the following when assembling:
1. Work on a level and stable surface.
2. Ensure enough space for assembling.
3. Use the enclosed parts/accessories for assembling.
6.4.3. Assembling disinfectant nozzle holder/disinfectant tray
NOTE
The screws used in this machine are ISO metric screw threads. Use the tools that meet the
metric screw threads.
1. Unscrew the 8 screws [(A) circled in

the figure] to remove the back cover of
the hydraulic line. Since the tubes and
wires are connected to the main
machine, work carefully not to pull out
them.
2. Through the holes [(B) circled in the

figure above], attach the disinfectant
nozzle holder on the backside of the
removed back cover using the provided
screws. Attach the nozzle holder with the
flat side up. Tighten the nozzle holder
together with the cable fixture [(C) circled
in the figure on the left].
6-5
3. Fix the connector as (D) circled in
the figure with the cable fixture
tightened in step 2.
4. Remove the 4 truss head screws [(E)

circled in the figure].
5. Using the Phillips-head

screwdriver, fix the disinfectant
tray with the truss head screws
removed in the step 4.
6. Follow the step 1 procedure in

reverse to re-install the back
cover. Make sure not to fold the
tubes or pinch the wires.
6-6
7. Connect the disinfectant nozzle to
the edge of the thin tube hanging
from the below the fan of the back
cover of the hydraulic line.
8. When the disinfectant nozzle is not

used, store it as in the figure on the
right.
6-7
6.4.4. Assembling color lamp/ IV pole
1. Insert the hanger to the fixed pole as the figure above.

2. Attach the handle for pole into the thread on the fixed pole.
3. Fix the IV pole at an adequate height by tightening up the handle for pole.
4. Insert color lamp to the bracket.
5. Fix the color lamp using the spanner (26 mm) as the figure above.
6-8
6.4.5. Wiring for color lamp
Connect the cables for the color lamp.
1. Remove the screws at seven circled
sections in the right figure with the phillips
screwdriver.
2. Remove the backside panel by

sliding it in the arrow direction.
The earth cable and the fan harness
are connected to the backside panel.
Turn over the backside panel, taking
caution not to damage the power
supply cord, remove the fan connector,
and remove the earth cable with the
Phillips screwdriver.
3. There is an unconnected connector

at the circled portion in the right figure.
Connect the connector of the color lamp with
the unconnected connector.
6-9
4. Re-install the backside panel in the order
reverse to the above procedures. Ensure to
connect the earth of the backside panel and
the fan harness. When re-installling the
backside panel, pass the cable for the color
lamp through the recess at the circled
Recess for Color Lamp
portion in the right figure.
Cable
Take caution not to catch the cable.
6.5. Releasing Hinge at Operation Panel
Some models of operation panel are secured

with tape, not using with screws.
These models can release hinge at operation
panel only removing the tape.
Remove tape from the front edge.

Peel away the tape slowly not to remain the
substrate.
If the models that the operation panel does

not secured with tape, it is fixed with two screws.
Hole of Operation Panel
There are holes to unscrew the Fixing Screw
operating section fixing screws on (On Both Right and Left Sides)
both the right and left sides of the
control panel. To release the
hinge, insert the Phillips
screwdriver into the holes (on the
right and left sides) shown in the
right figure and remove the fixing
screws.
Membrane sheet has covered by protective thin film.

Peel the film from corner of membrane sheet.
6-10
6.6. Connections to Water Supply Inlet and Drain Outlet
6.6.1. Dimensions of connectors at water supply inlet and drain outlet
The connectors for the water supply inlet and the drain
outlet are as shown in the right figure.
When selecting a hose to use for water supply and
drainage, select one in the dimensions suit for the
connectors.
Unit: mm
6.6.2. Connecting the water supply hose
When connecting a hose that can resist water supply specifications to the water supply
inlet, fully insert it to the depth of the inlet port and be sure to secure it with the hose band.
DANGER
Insert the hose to the distal end of the water supply opening. Use a hose band to secure the
connection.
6-11
6.6.3. Connection to drain outlet
Use a hose for drain outlet equal to the one used for the water supply inlet.
When connecting a hose to the drain outlet, fully insert it to the depth of the outlet and be
sure to secure it with the hose band.
Also, regulate the length of the drain tube within 3 meters and avoid connecting the hose
with the drain outlet at the height of 60 cm or less from the floor level.
Drain hose
Drain outlet
Drainage 60cm or less
DANGER
Changes in the height of the drainage or clogging in the drain tube can cause errors in ultra
filtration.
CAUTION
Install the drain system appropriately in accordance with your community rule.
6-12
6.7. Connecting the power plug
Securely insert the power plug to the depth of the specified outlet.
CAUTION
The power specification is noted on the machine nameplate and near the breaker. Be sure to
apply the proper voltage when connecting to the machine.
CAUTION
Use the machine with equipotential grounding. If equipotential grounding cannot be established
at an outlet at the installation location, use the equipotential grounding terminal at the rear of the
machine. The terminal can be used only for equipotential grounding.
DANGER
Make sure that the electric power equipment at the installation location provides the voltage that
is proper to the machine before connecting them. Improper voltage may cause serious accidents
as well as machine malfunctions.
DANGER
If the protective grounding of the machine is incorrect, an electric shock due to a machine
malfunction or short circuit may happen. Make sure that a double-pole-grounding outlet is
correctly connected and protective grounding is assured at the installation location.
6.8. Water Supply

Fill the dialysate line with water by executing the water supply program.
You have to login in the MAKER mode to execute it. Never allow any person
other than a qualified to perform the operation.
CAUTION
Execute the water supply program before operating the machine after its installation. When the
machine is operated with water not filled in the dialysate line, the machine may be defected.
6-13
6.9. Disposal of the Machine
Following matters should be concerned when disposing the machine. Keep the following
matters in mind and dispose the machine properly in accordance with the local regulation
in your area.
6.9.1. Disposal of the main machine

The primary materials composing the machine are electric circuit boards, harness, resins
in rubber, exterior, etc., stainless/steel frames, and ceramics. Dispose these parts as
industrial wastes or in accordance with the local regulation when applicable.
6.9.2. Disposal of LCD display

A fluorescent electrode tube is used in the LCD display. Dispose the display after
checking if a disposal method is specified in your area.
6.9.3. Disposal of the backup batteries

The backup battery used in case of power failure is equipped as an option of this machine.
It is a lead storage battery. Process the backup battery in accordance with the local
regulation in your area.
Be sure to follow the following points when disposing the battery:
1. Do not throw the battery into fire or apply heat, as it may result in battery leakage, fire
disaster, or explosion.
2. Electric energy yet remains in a used battery. Insulate a used battery to avoid
interelectrode contact by taping battery terminals, harnesses, etc.
3. Do not apply strong impact on the battery by throwing or dropping.
4. Never disassemble the battery because the battery contains dilute sulfuric acid.
DANGER
If a battery damage results in leakage and electrolytic solution spills on skin or clothes, flush with
plenty of water without delay. If the spilled electrolytic solution contacts the eye, flush with plenty
of water and receive treatment from a doctor immediately. Dilute sulfuric acid can cause loss of
sight and skin burn.
6-14
7 Specifications
7.1. Major Functions

The followings are the major functions of this machine:
(a) Bicarbonate dialysate
(b) Acetate dialysate
(c) UF (ultrafiltration) function (fixed quantity change method by switching chamber)
(d) UF (ultrafiltration) profile
(e) Single needle (SN) single pump dialysis
(f) Sequential dialysis
(g) Rinse program
(h) Blood pump
(i) Syringe pump
(j) Air bubble detector
(k) Venous clamp
(l) Self-diagnosis function
(m) Startup test
(n) Message function
(o) Automatic priming
(p) Blood leak detector
(q) Sodium profile (A-concentrate profile)
(r) Bicarbo profile (B-concentrate profile)
(s) Level adjuster for bloodline chamber
7-1
7.2. Disposables and consumptive material
The following is the standard disposable list of the machine. Use disposables such as
dyalizers, bloodline, and sylinges, and dialysates specified in the following table.
We will not be liable for any trouble or accident caused by using non-standard products.
CAUTION
USE only CE mark disposable products affixed with CE marking.
7.2.1. Disposables
• Dialyzers
ELISIO series
FB series
PUREFLUX series
SUREFLUX series
SURELYZER series
• Bloodlines
NIPRO Blood tubing set
A121/V691
• Disposable syringes
NIPRO Syringe 10mL (luer lock tip)
7.2.2. Consumptive material

Hemodialysis concentrates
7-2
7.3. Electromagnetic Interference
The machine is compliant with, IEC60601-1-2, the EMC standard for conformity, and
designed for the tolerance to electromagnetic wave radiation. However, devices
generating strong electromagnetic wave such as transceivers or mobile phones are not
intended to be used near the machine.
Do not use such devices near the machine as the strong electromagnetic wave may
cause machine malfunctions.
CAUTION
EMC needs to be considered when the machine is used. Read carefully the information about it
in the attached document before installing and using the machine.
7.4. Important Documents

For information on the machine such as check and maintenance, electric diagrams and
the explanation, or maintenance part lists to use the machine correctly, contact the
manufacturer.
For the following information, too, contact the manufacturer.
• Information on the test to confirm the effectiveness of sterilization and disinfection
• Information on the blood flow movement related to the single needle movement when
the recommended dialyzer, bloodline, and catheter are used.
7-3
7.5. Dimensions and Weight
Specification NOTE
Dimension W: 400mm (Body. Without Base) Dimensions of Base: 465(W) ×
D: 435mm (Body. Without Base) 985 (D): Including disinfectant
bottle base (760mm for without
H: 1350mm (Without IV pole and Signal tower)
disinfectant bottle base)
H: 1750mm (With signal tower)
H: 1490 to 1900mm (With IV pole without Signal tower)
Weight Approx. 110kg (Dry condition) Without liquid at hydraulic.
Airborne Noise The A-weighted instantaneous sound pressure Maximum sound pressure:53dB
level :Under 70dB (Measured at a distance of 1
meter from the back side and at a
height of 1.6 meters from the
floor.)
7.6. Electrical Safety (Ordered by EN60601-1)

Specification NOTE
Class of electrical CLASS I None
classification
Type of electrical Type B Symbol:
classification Applied part: Dialysate Circuit
Type BF applied part: Cuff for

BPM option.
Protection against the IPX1 Symbol: IPX1
penetration of fluids
Leakage currents In normal condition: None

Earth leakage current: 0.5 mA or less
Enclosure leakage current: 0.1 mA or less
Patient leakage: 0.1 mA or less
At single fault condition:
Earth leakage current: 1.0 mA or less.
Enclosure leakage current: 0.5 mA or less
Patient leakage: 0.5 mA or less
EMC EMC standard for conformity: None
IEC60601-1-2 Ed. 2.0: 2001
7-4
7.7. Electrical Supply
Specification NOTE
Line voltage AC230V Type: 230 V AC, ±10% It has Battery option. See option
AC110V Type: 110 V AC , ±10% specification.
Frequency 50 Hz/ 60 Hz
Power consumption Equipment: Less than 2200 VA

(At rated power supply)
7.8. Fuses
Specification Qty. NOTE
Circuit Breaker Circuit protector 2 X 15A （230V） - Rear of Power Supply Unit
Circuit protector 2 X 25A （110V）
Heater Control Unit Tube Fuse AC250V T8.0AH 2 230 V AC Type only
Pump Driver Board Tube Fuse AC250V T3.15AL 2
Battery Tube Fuse AC250V T6.3AH 1
7.9. External connections

Specification NOTE
RS-232 Interface for serial communication with Not used at the moment
computer.
7-5
7.10. Operating Conditions
Specification NOTE
Water inlet 0.1 up to 0.73 MPa (1.0 up to 7.5 kgf/cm2) None
Pressure
Water inlet flow More than 1100 mL/min
Water inlet 5°C up to 30°C ·To be at least 5°C lower than
temperature dialysate set temperature.
·Fluctuation of temperature per 1

min. must be within ±1°C.
Water drain Minimum drain capacity: More than 1500 mL/min No less than 5 cm free fall. The
water drain must be located at a
Height of drain: Max 60 cm above the ground. lower level than that of the
dialyzer position.
Concentrate supply 0.00 to -0.01MPa (0.000 up to -0.102 kgf/cm2)
Connection height: Max. 50 cm
Mode of operation Continuous Operation
Environment of Not designed to use in the an oxygen rich,
usage presence of the flammable anesthetic mixture
with air, oxygen, or nitrous oxide.
Surrounding space Following clearance must be secured against None
outside dimensions of equipment.
Top clearance: 5 cm or more
Side clearance: 10 cm or more
Rear clearance: 20 cm or more
For ventilation, there must be a ventilation
opening of Φ20cm or more, or one of top, side,
and rear must be open to atmosphere.
Range of operating 15 to 35°C To be at least 5°C lower than
temperature dialysate set temperature.
Air humidity 35 to 80% Non condensing
Norms for water Use water of quality meeting AAMI - approved None
quality American National Standard for Haemodialysis
System, RD5, 1981, Section 3.2.
7-6
7.11. Storage and transportation
Specification NOTE
Storage -20 to 40 °C (without water in piping) Factory default: Water is
temperature 5 to 40 °C (with water in piping) eliminated when shipped
Storage humidity 10 to 90% Non condensing
Transportation -20 to 40 °C (without water in piping) None
temperature 5 to 40 °C (with water in piping)
Transportation 10 to 90% Non condensing
humidity
Atmospheric 700 to 1062 hPa None
pressure
7.12. Hydraulics
7.12.1.Blood Leak Detector
Specification NOTE
Method Optical
Sensitivity Range: 0 to 370 ppm (1ppm increment) 190ppm (0.19 mL blood/L,
Hematocrit 32%)
CAUTION
When the dialysate flow turned off, the Blood leak alarm response is delayed.
The reaction time depends on the volume between the dialyzer and the Blood leak detector
(approx. 200mL total fluid volume) and as well on the Ultrafiltration rate.
7.12.2.Transmembrane Pressure
Specification NOTE
Alarm range Lower limit: -100 to 300 mmHg (Back filtration None
alarm)
Upper limit: 10 to 600mmHg
Calculation TMP
=PG5-PG3+TMP OFFSET
PG3 = Dialysate pressure at the exit of the
dialyzer
PG5 = Venous pressure.
TMP OFFSET = Pressure changes depending
on flow
Accuracy ±20 mmHg
7-7
7.12.3.Dialysate Pressure
Specification Condition
Measurement range -450 up to +450 mmHg None
Accuracy ±10 mmHg
Auto fixing Alarm Lower Width: -200mmHg to -50mmHg (Relative value from present
range Upper Width: 50 mmHg to 200 mmHg value)
Alarm Limit Lower limit: -450 to 450 mmHg None
(On shipment: -400 mmHg)
Upper limit: -450 to 450 mmHg
(On shipment: 450 mmHg)
7.12.4.Ultrafiltration
Ultrafiltration rate 0.00 L/h, 0.10L/h up to 5.00 L/h Set to Max. 2 L/h on shipment.
Accuracy 0.10-3.00 L/h: ±30 g/h PG5: 150mmHg
3.00-5.00 L/h: 1% of setting When equipment is adjusted in
the accuracy same as done on
shipment.
Accuracy of UF time Within 1sec / h
Control and Safety Volumetric system by the balancing chamber. None
system Monitoring of UF pump, TMP
Max. ratio of UF 10 to 100% (Setting is possible by 1%
pump against BP increment.)
UF-Profile 6 types of profile can be selected.
UF-Volume 0.00 to 99.99 L 0.01L increment
7.12.5.Degassing
Specification NOTE
Deaeration Negative pressure deaeration method None
method
Dissolved Max.: 0.019 MPa (140 mmHg) When water temperature
gas in at deaeration is 37°C
dialysate When dissolved oxygen
partial pressure at
deaeration is 0.027 MPa
(200 mmHg)
7.12.6.Acetate Dialysis
Setting range 10.0 to 17.0 mS/cm (0.1 mS/cm increment) On shipment, TOTAL is set to a
value within (12.6 to 15.4 mS/cm)
range.
Accuracy ±0.3 mS/cm
Alarm range 1 to 20% of set value (On shipment: 4%) CD1 and CD3
Dilution ratio 1/20.00 to 1/45.00 (Input denominator by 0.01 None
increment.)
7-8
7.12.7.Bicarbonate Dialysis
Bicarbonate Setting 1.0 to 8.0 mS/cm (0.1 mS/cm increment) On shipment, W+B is set to a
range value within (2.5 to 3.1 mS/cm)
range.
Accuracy ±0.3mS/cm
Bicarbonate 1 to 14% of set value (On shipment: 7%) CD2 and CD4
Alarm range
Bicarbonate 1/20.00 to 1/70.00 (0.01 increment) None
Dilution ratio
Total Mixed Setting 10.0 to 17.0mS/cm (0.1mS/cm increment) On shipment, TOTAL is set to a
range value within (12.6 to 15.4 mS/cm)
range.
Accuracy ±0.3 mS/cm
Total Mixed Alarm 1 to 20% of set value (On shipment: 4%) CD1 and CD3
range
Dilution ratio 1/20.00 to 1/45.00 None
(Input denominator by 0.01 increment.)
7.12.8.Dialysate Temperature
Setting range 30.0°C up to 40.0°C (0.1°C increment) Inlet water temperature must be
(On shipment: 36 to 38°C) at least 5°C higher than dialysate
set temperature.
Surrounding temperature must
be at least 5°C lower than
dialysate set temperature.
Accuracy Measured value ± 0.8°C Measured value = Average for 1
min.
Alarm range 29.0°C to 41.0°C (0.1°C increment) T1 and T3 sensors
Sensor type Thermistor None
7.12.9.Dialysate Flow Rate

Specification NOTE
Setting range 300 to 700 mL/min
Accuracy ±10%
Safety system Monitoring of the Flow switch 2.
7-9
7.13. Extra corporeal Blood Circuit
7.13.1.Arterial Pressure
Specification NOTE
Measurement range -300 to +600 mmHg None
Accuracy ±10 mmHg
Auto fixing Alarm Lower Width: -200mmHg to -10mmHg (Relative value from present
(On shipment: -300 mmHg)
(On shipment: 300mmHg)
7.13.2.Venous Pressure
Specification NOTE
Measurement range -300 to +600 mmHg None
Accuracy ±10 mmHg
Auto fixing Alarm Lower Width: -200 mmHg to -10 mmHg (Relative value from present

Level adjuster Pressure infusion button does not work during None
Venous pressure high alarm condition for
preventing over pressure.
7.13.3.Air Detector
Specification NOTE
Sensor type Ultrasonic sensor None
Applicable tube Tube material: Soft PVC However, limited to NIPRO's
standard bloodline for DIAMAX.
Detection capability <Single bubble> ·Flow rate: 200mL/min
Outputs alarm when a bubble of setting value or ·Fluid temp: 37±1.0°C
more is detected. Detecting sensitivity differs
Single bubble: 1.0 ~ 10.0µL (0.1µL increment) depending on flow rate of the
<Total bubble> bubble that passes bubble
Output alarm when bubbles of setting value or sensor.
more is detected during setting time.
Total bubble: 1.0 ~ 1000.0µL (0.1µL increment)
Accumulate Time: 0 ~ 600 sec
Sensitivity 0.3 ~ 10.0µL (0.1µL increment)
7-10
7.13.4.Blood Pump
Blood pump type 2 roller type None
Automatic gap adjustment Spring gap on shipment:

(Gap adjustment spring: For large dia. tube: 3.5 3.5 mm (one side)
to 4.0 mm, For small dia. tube: 4.0 to 5.0 mm)
Setting range For large dia. tube Large dia. tube:
25 to 600 mL/min φ8.00×φ12.00±0.15 mm
Length: 210 mm or more
(On shipment: 50 to 600 mL/min)
For small dia. Tube Small dia. tube:

15 to 550 mL/min φ6.35×φ9.75±0.15 mm
Length: 210 mm or more
(On shipment: 50 to 450 mL/min)
(Min. and Max. flow rate may not

be achieved by permanent
fatigue, etc. of rolling tube.)
Accuracy 50mL/min or more: ±10% of set value Entrance pressure
Less than 50mL/min: ±20% of set value : Within ±150 mmHg
Exit pressure
:0 up to + 500 mmHg
BP stop alarm delay 0 to 120 sec. (Setting is possible by 1 sec. Time from BP stop till alarm
time increment.) output
7.13.5.Syringe Pump
Type One cylinder type ·NIPRO 20mL standard syringe
Setting range 0.1 to 20.0 mL/h On shipment: 0.1 to 10.0 mL/h
Accuracy ±10% NIPRO 20 mL syringe

Overload detection Detection load: Approx. 53.9 to 58.8 N/cm 2 When NIPRO 20cc new syringe
(Approx. 5.5 to 6.0 kgf) (with low pusher resistance) is
used, discharge pressure will be
approx. 600 to 700 mmHg.
Fast infusion Approx. 2200 mL/h (NIPRO 30 cc syringe)
(Rapid speed) Approx. 1500 mL/h (NIPRO 20 cc syringe)
Approx. 750 mL/h (NIPRO 10 cc syringe)
One-shot infusion 0.5 to 10.0 mL NIPRO 20 mL syringe
(Bolus volume)
Prior stop function 1 to 60 min None
Other applicable 10, 20 and 30mL syringe None
syringe (full scale length : 15mm ~ 90mm)
7-11
7.13.6.Single Needle Single Pump
One stroke 0 to 1000 mL
minimum blood (Setting is possible by 1mL increment.)
volume
Reaction time over 5 to 30 sec.
(Setting is possible by 1 sec. increment.)
Rotation limit over 1 to 1000 mL On shipment: 100 mL
alarm
Setting range of Lower limit: -200 to -10 mmHg (Relative value from present
blood pressure (Setting is possible by 10 mmHg increment.) value)
switching alarm Upper limit: 10 to 200 mmHg
(Setting is possible by 10 mmHg increment.)
Possible setting Min.: -350 to 550mmHg
range of blood (Setting is possible by 10 mmHg increment.)
pressure switching Max: -350 to 550 mmHg
alarm
(Setting is possible by 10 mmHg increment.)
7.14. Rinse
Specification NOTE
Water rinse Rinse time: 10 to 60 min Rinse
Hot water rinse Set temperature: 75 to 85°C, and Rinse time: Rinse
20 to 60 min
Acetic acid rinse Acetic acid concentrate 5 to 70%, Dilution Decalcification
concentration: 0.5 to 5%, and Rinse time: 20 to
60 min
Citric acid rinse Citric acid concentrate: 10 to 50%, Dilution Decalcification
concentration: 1 to 10%, and Rinse time: 20 to
60min
Hot citric acid Set temperature: 75 to 85°C, Citric acid Disinfection and Decalcification
disinfection concentrate: 10 to 50%, Dilution concentration: 1
to10%, and Rinse time:
20 to 60 min
Peracetic acid Peracetic acid concentrate: 3 to 12%, Dilution Disinfection and Decalcification
disinfection concentration: 0.01 to 0.3%, and Rinse time:
20 to 60 min
Sodium Sodium hypochloride concentrate: 3 to 12%, Disinfection
hypochloride Dilution concentration: 0.01 to 0.3%, and Rinse
disinfection time:
20 to 60 min
Dwell Soaking time: 1 to 60 min
7-12
7.15. Options
7.15.1.Battery
Specification NOTE
Type Valve regulated (sealed) lead-acid battery None
Capacity 24 V / 7Ah (12 V * 2) None

Charging time 72h Charged when the breaker is
“On”
Continuous More than 30 min. When new and fully charged
operation time
Storage -15 to 40 °C None
temperature
Note: Deterioration of the battery can decrease continuous operation time. Exchange batteries
periodically by referring to the maintenance manual.
Ensure to full charge the battery before long-term storage.

Periodical charging can decrease battery deterioration during long-term storage. The following
table shows an example of storage temperatures and charging intervals.
Storage temperature Intervals between charging battery

25°C or less Within 6 months
40°C or more Do not store at this temperature
WARNING
Replacement of the Battery, please replace factory-authorized battery.
7.15.2.Dialyzer Inlet Pressure

Specification NOTE
Measurement range －250 to 650mmHg None
Accuracy ±10mmHg
Auto fixing Alarm Lower Width ：-200mmHg～-10mmHg (Relative value from current value)
range
Upper Width：10mmHg～200mmHg
Alarm Limit Lower limit：-250 to 650mmHg None
Upper limit：－250 to 650mmHg
7-13
No. Name
1 Chassis
2 Cover
3 Caster
4 IV Pole
5 Hanger
6 Indication lamp (Red)
8.1. Machine Components
7 Indication lamp (Yellow)

8 MACHINE CONFIGURATION
8 Indication lamp (Green)

9 Indication lamp (Blue)
11 Dialysis coupler holder
8-1
12 Coupler switch
13 Dialysate supply tube
14 Dialysate return tube
15 CF connection port (Option)
16 Disinfectant tank table
17 Tray (Option)
44 Water supply port
45 Drain port
117 Disinfectant 1 nozzle
152 B concentrate nozzle’s sheath
153 A concentrate nozzle’s sheath
162 Battery (Option)
8.2. Names and Functions of Machine Components
No. Name Function and Operation
1 Chassis Frame to support each component of the machine
2 Cover Protects each component of the machine.
3 Caster Wheels to transport the machine
4 IV Pole Height adjusted pole that supports the hunger
5 Hanger Hangs substitution fluid container, etc.
6 Indication lamp (Red) Displays the color light that shows warning.
Displays the color light that shows notification to
7 Indication lamp (Yellow) operator in normal operation or shows the state of a
process.
Displays the color light that shows the operation of a
8 Indication lamp (Green)
specific process.
Displays the color light to show the nurse call is
9 Indication lamp (Blue)
activated.
11 Dialyzer coupler holder Connects the dialyzer coupler in the rinse process.
Detects the connecting condition of the dialyzer

12 Coupler switch
coupler to the coupler holder.
13 Dialysate return tube Collects the dialysate that comes out of the dialyzer.
14 Dialysate supply tube Sends the dialysate to the dialyzer

16 Disinfectant tank table Holds the cleaning solution/disinfectant bottles.
Being placed on the top of the machine, places tools
17 Tray
and devices to use during dialysis on it.
44 Water supply port Inlet of the hose to supply clean water to this machine
Outlet of the hose to drain the collected waste fluid
45 Drain port
from this machine
Aspirates the concentrate, being inserted into the
117 Disinfectant 1 nozzle
cleaning solution/disinfectant bottles.
152 B concentrate nozzle's sheath Sheath to rinse the aspiration nozzle for B concentrate
153 A concentrate nozzle's sheath Sheath to rinse the aspiration nozzle for A concentrate
Supplies the power at the time of blackout to interrupt
162 Battery (Option)
the treatment safely.
8-2
9. CONFIGURATION OF OPERATING SECTION
9.1. Operation Panel
9-1
9.2. Names and Functions of Operation Panel
Panel furnished with the operating switches and a touch

18 Control panel panel display to operate the dialysis machine or observe its
operating conditions
Power ON/OFF switch Switch to start the machine from its standby condition and to
19
(with lamp) stop it
Being connected with the AC power supply, turns ON when
20 AC supply lamp
the power supply breaker is ON.
It indicates a battery state. Blinks when battery is charging,
21 Battery lamp
turns ON when completion of charge is carried out.
Blinks when an alarm has occurred, turns ON when the
22 MUTE/RESET lamp MUTE switch is pressed, and turn OFF when the alarm is
reset.
23 MUTE switch Press to turn OFF the alarm sound.
24 RESET switch Press to reset an alarm.
Pump1 ON/OFF
25 Turn this switch ON or OFF to the blood pump 1.
switch
26 Blood pump 1 lamp Turns ON when the blood pump 1 is being operated.
27 No Use
28 No Use
Furnished with touch keys. Operate the touch keys to make

29 Touch panel
settings or operate the machine.
Displays the information and switches to operate the

30 Display
dialysis machine.
9-2
9.3. Bloodline Set Panel
9-3
9.4. Names and Functions of Bloodline Set Panel
Panel furnished with the operating switches and a touch

18 Control panel panel display to operate the dialysis machine or observe its
operating conditions
25 Pump1 ON/OFF switch Turn this switch ON or OFF to the blood pump 1.
Surface adjustment
Adjust the fluid level in the venous chamber up and down
32 switch (venous
with the UP or DOWN button.
chamber)
Arterial pressure 1 Connect the tube for measuring the pressure of the artery
34
connection port chamber 1.
Venous pressure Connect the tube for measuring the pressure of the venous
35
connection port chamber.
37 Tube guides Support and stabilize the blood line.
133 Blood pump 1 Sends blood to the dialyzer.
Connects to the blood line to inject the anticoagulant such

134 Syringe pump
as heparins.
138 Air bubble sensor Detects air bubbles mixed in the blood line.
Detects the change from blood to the saline solution or from
139 Blood detecting sensor
the saline solution to blood.
Clamps the tube of the venous side blood line to block the
140 Venous clamp
flow of blood.
9-4
9.5. Power Supply Section
9.6. Names and Functions of Power Supply Section

Panel furnished with buzzer, hour meter, power supply
38 Backside panel
breaker, power supply cord, and cooling fan
39 Buzzer Outputs acoustic alarm.
41 Power supply breaker Provides or shuts down the power supply to the machine.
42 Power cable Electric cord to supply power to the machine
43 Cooling fan Cools down the inside of the control section.
161 RS232C connector Unused
9-5
10 ACTIVATION OF ALARM AND ITS RESETTING METHOD
In case the machine detects some problems, the machine activates the warning light and
sound buzzer, and then displays the alarm on the screen in order to inform the operator of the
situation. Moreover, the machine is equipped with the safety system and performs the
emergency operations automatically such as stopping the dialysis, depending on the severity
of the contents of the alarms.
WARNING
If an alarm is triggered repeatedly, stop the machine immediately, discontinue the dialysis, and
then disconnect the patient from the machine. Otherwise the patient may suffer serious damage
on his or her health.
10.1. Emergency Stop

If it is necessary to stop the machine in an emergency, press the POWER ON/OFF switch
for three seconds or more.
All the operations will stop urgently and the power supply will be shut down.
After taking all corrective action, press the POWER ON/OFF switch again.
DANGER
When an emergency stop is required, check that the patient will not be harmed by the sudden
operation stop. If any harm is expected, be sure to treat the condition before stopping.
DANGER
After an emergency stop, remain monitoring the patient closely.
10-1
CAUTION
If the POWER ON/OFF switch does not work properly, turn OFF the breaker at the rear of
machine to bring the machine to an emergency stop.
An emergency stop by the breaker generates an alarm sound indicating that the breaker is OFF.
To turn OFF the sound, press the MUTE switch.
When the breaker is OFF, press and hold the POWER ON/OFF switch for a while. The power is
turned ON and the machine restores the previous action.
Power ON/OFF switch
Operation panel
Breaker
Rear of machine
NOTE
The optional backup battery is used for safety operation in case of an emergency stop.
When the breaker is turned off, the system activates an emergency stop regardless of the
presence of the backup battery.
10-2
10.2. Operations of the Machine When Abnormality Has Occurred
When a problem occurs, the machine activates the following operations in combination
according to the type of the alarm:
(a) Screen display of the alarm
Displays the name of the alarm at the warning display area in the display screen.
When two or more alarms have been detected, those alarms will be displayed at the
warning display area from the top in the order of detection.
(b) Screen display of the alarm message
Displays the contents of the alarm with the alarm No. at the message area in the
screen.
Three types of alarms can be displayed at one time, taking one line for one message.
When displaying four or more alarms in the screen, the messages are scrolled at the
message display area every two seconds.
(c) Buzzer
Buzzer sounds, and the MUTE/RESET switch lamp on the operation panel turns ON.
(d) Indication lamp
A red lamp blinks.
(e) Hydraulic line stop
The pumps P1 and P2 stop, the valve, the heater stops, and then the liquid flow stops.
(f) UF (ultrafiltration) stop
The UF (ultrafiltration) operation stops.
(g) Automatic bypassing
Stops the dialysate supply to the dialyzer by bypassing the coupler line.
(h) Blood pump and syringe pump stop
The blood pump and the syringe pump stop.
(i) Clamp
Clamps the blood line temporarily when 1) the air bubble alarm occurs, and 2) an
alarm related to the concentrate pressure occurs.
(j) Depressurization or air relief
When the concentrate pressure is over the specified value, an alarm is triggered, and
the pressure is automatically released. Also, when air is accidentally mixed to the
dialysate such as in connecting the dialyzer, the machine automatically releases the
air.
10-3
10.3. When alarm goes off
Follow the following procedures when the alarm goes off:
1 Press MUTE to stop the alarm.

‧ The alarm sound stops.
‧ The light indicator changes from red blinking to red light.
NOTE
When two minutes have passed without removing the causes of the alarm, the alarm buzzer
sounds again. But in RINSE PROSESS, when two minutes have passed without removing the
causes of the alarm, the alarm buzzer does not sound.
NOTE
Some alarms go off automatically, depending on types of events. See Alarm Table for details.
2 Find the alarm number/name from the Alarm Table to identify the cause.
3 Eliminate the cause of the alarm.
4 Press RESET to resume normal operation.
‧ The red light indicator will be turned off.
‧ The system resumes normal operation.
RESET SWITCH
MUTE Switch
RESET Switch
MUTE SWITCH
10-4
10.4. Interpretation of the Alarm and Information Table
The following details are included in the Alarm and Information Table:
2
3
4
5
6
7
No. Name Detail

Alarm number and name that is displayed in case of an alarming event.
Alarm/Alarm
1 During an alarm, this number and name are displayed in the warning
name
display field.
The process that this alarm is being monitored for. Processes are
2 Detection
not monitored unless they are described in this field.
CPU that is monitoring this alarm. No CPUs will be monitored for the
corresponding alarms.
3 Monitoring CPU Control Section ・・・・Control CPU
Monitoring Section・・・Monitor CPU
Display Section ・・・・Display CPU
Detection
4 Describes triggers for the alarm.
condition
Indicates the operations performed by the system after an alarm is
triggered.
“－”・・・・・No operation
5 Operation
“○”・・・・・Operation
“Setting”・・・Operation varies depending on system settings
See 10.1 Operation for emergency for details.
6 Reset condition Describes conditions for an alarm to reset.
7 Note Special conditions and references are described in this field.
10-5
10.5. Numbers for alarms and information
The displays of alarm and information with this system is divided to the following number.
A Alarm
System ····················································· No.0001~
Temperature sensor ···································· No.0020~
Electrical conductivity sensor ························· No.0040~
Blood pressure/dialysis pressure sensor ·········· No.0060~
Single needle ············································· No.0090~
Air bubble sensor ········································ No.0100~
Leaking blood sensor ··································· No.0110~
Flow switch ··············································· No.0120~
Air separator ·············································· No.0130~
UF ··························································· No.0140~
TMP ························································ No.0150~
Sheath / Nozzles ········································ No.0160~
Dialyzer coupler ········································· No.0170~
Central Option (1) ·········································· No.0184~
CF ··························································· No.0190~
Clamp ······················································ No.0200~
Central Option (2) ·········································· No.0202~
Heparin pump ············································ No.0230~
BPM Option ··············································· No.0300~ (Refer to Option manual)
Kt/V ························································· No.0400~
B Start-up test results

Temperature sensor ···································· No.0800~
Blood pressure/dialysis pressure sensor ·········· No.0830~
Air bubble sensor ········································ No.0850~
Leaking blood sensor ··································· No.0860~
Pump ······················································· No.0870~
Clamp ······················································ No.0880~
Valve ························································ No.0890~
Occlusion leaking ········································ No.0900~
CF leaking ················································· No.0910~
C Information
Displaying in red ········································· No.1000~
Displaying in black ······································ No.2000~
D Operation history ····································· No.3000~
10-6
0001 EMERGENCY STOP
Detection Processes other than Rinse standby and Rinse end
Control section
Power supply was turned OFF by operating power switch.
Detecting
condition
Operation Lamp Sound BP stop HP stop Clamp close Bypass UF stop Heater OFF Hyd. line stop
― Beep ― ― ― ― ― ― ―
Reset
condition
Note
0002 AC POWER FAILURE

Detection Always
Control section & Monitoring section
Power failure interruption has occurred.
Detecting
condition
Red blinks Beep ☆ ― ☆ ○ ○ ○ ○
Reset Automatically resets and restarts operation after power failure signal turns OFF.
condition
Note Waits recovery from failure under power failure condition.
☆-mark shows that enable signal is output even when other alarm is being output.
Refer to Information 2000.
0003 POWER UNIT FAILURE

Detection Always
Detecting Power unit failure interruption has occurred.
condition
Red blinks Beep ○ ○ Venous line ○ ○ ○ ○
Reset Cleared by resetting alarm, and operation is restarted.
condition
Note Stops all operations in present process until alarm RESET button is pressed.
0004 CPU1 FAULT

Detection Always
Monitoring section & Display section
Detecting Communication error has occurred with control section (CPU1).
condition ･Transmission retry error has occurred (3 times at intervals of 3 sec.).
･Monitoring data from control section was not received for 3 sec.
Reset Turn OFF and ON power supply.
condition
Note Stops all operations in present process.
10-7
0005 CPU2 FAULT
Detection Always
Control section only
Detecting Communication error has occurred with monitoring section (CPU2).
condition
0006 LCD FAULT

Detection Always
Detecting Communication error has occurred with display section (LCD).
condition
0007 BACK-UP MEMORY VERIFY FAULT

Detection Always
Detecting Checksum error occurred in the backup memory.
condition Discrepancy was found by inversion check.
Reset Return backup data to the factory present values.
condition →Set Bit 4 (parameter) and 5 (calibration data) of DIPSW 2 ON and turn power supply ON again.
0009 SWITCH FAULT

Detection Always
Detecting Membrane switch has been ON for 150 sec. continuously.
condition
Red blinks Beep ― ― ― ― ― ― ―
Reset Restarts by resetting alarm.
condition
Note
10-8
0010 CPU TEST NG
Detection Power ON, startup test
Detecting CPU test failed.
condition
Reset Turn OFF and ON the power supply.
condition
Note Stops all operations in the present process.
0011 ROM TEST NG

Detecting ROM test failed.
condition
condition
0012 RAM TEST NG

Detecting RAM test failed.
condition
condition
0020 OVERHEAT
Detection Always
Detecting Thermostat was activated.
condition
Red blinks Beep ― ― ― ○ Setting ○ ―
Reset Restarts operation by resetting alarm.
condition
Note
10-9
0021 T1 SENSOR FAULT
Detection Always
Detecting T1 was 97 ℃ or more, or 3 ℃ or less for 2 sec. continuously.
condition
condition
Note

Detection Always
condition
condition
Note

Detection Always
condition
condition
Note

Detection Always
condition
condition
Note
10-10
Detection Always
condition
condition
Note
0028 T2-T4 TEMPERATURE DIFFERENCE FAULT

Detection Preparation, Preparation end, Dialyzer rinse, Dialyzer rinse end, Dialysis, Dialysis end, Retrans
Detecting Difference between T2 and T4 is over set value for set time continuously.
condition ( Monitored only when existence of flow is being detected by FS1.)
condition
Note Not monitored when hydraulic line is stopped in SEQ-UF process.
Not monitored when testing closed circuit.
0029 T1-T3 TEMPERATURE DIFFERENCE FAULT

Detecting Difference between T1 and T3 is over set value for set time continuously.
condition (Monitored only when existence of flow is being detected by FS2.)
condition
Note Not monitored when hydraulic line is stopped in SEQ-UF process.
0030 DIALYSATE TEMPERATURE OVER

Detection Preparation, Preparation end, Dialyzer rinse, Dialyzer rinse end, Dialysis, Dialysis end, and Retrans
Detecting T1 or T3 has been 41 ℃ or more.
condition
Reset Automatically resets, restarting operation when both T1 and T3 lower to 39 ℃ or less
condition for 10 sec. continuously.
Note
10-11
0031 DIALYSATE TEMPERATURE UPPER LIMIT
Detection Preparation end, Dialyzer rinse, Dialyzer rinse end, Dialysis, Dialysis end, and Retrans
Detecting T1 or T3 was more than set value
condition ･A: Prep End- Dialyzer Rinse: Monitors average value during chamber filling time
･B: Dialyzer Rinse End - Retrans: Monitors instantaneous value
Red blinks Beep ― ― ― ○ Setting ― ―
Reset ･A: Automatically resets and restarts operation when both are less than the set value.
condition ･B: Automatically resets and restarts operation when both are less the value for 10 sec. continuously.
Note Not monitored when hydraulic line is stopped in re-preparation process and SEQ-UF process.
0032 DIALYSATE TEMPERATURE LOWER LIMIT

Detecting T1 or T3 was less than set value
condition ･A: Prep End- Dialyzer Rinse: Monitors average value during chamber filling time
･B: Dialyzer Rinse End - Retrans: Monitors instantaneous value
Reset ･A: Automatically resets and restarts operation when both are more than the set value.
condition ･B; Automatically resets and restarts operation when both are more the value for 10 sec. continuously..
Note Not monitored when hydraulic line is stopped in re-preparation process and SEQ-UF process.
0033 HEAT TIME OVER

Detection Rinse
Detecting Actual temperature did not reach target temperature within preset heat-up time.
condition
condition
Note
0040 CD2-CD4 CONDUCTIVITY DIFFERENCE FAULT

Detecting Difference in conductivity between CD2 and CD4 is over set value for set time continuously.
condition (Monitored only when existence of flow is being detected by ＦＳ1.)
condition
Note Not monitored when closed circuit is tested and when hydraulic line is stopped in SEQ-UF process.
10-12
0041 CD1-CD3 CONDUCTIVITY DIFFERENCE FAULT
Detecting Difference in conductivity between CD1 and CD3 is over set value for set time continuously.
condition (Monitored only when existence of flow is being detected by ＦＳ2.)
condition
Note Not monitored when closed circuit is tested and when hydraulic line is stopped in SEQ-UF process.
0042 B+W CONDUCTIVITY UPPER LIMIT

Detection When dialysate is OK
Detecting CD2 or CD4 has become more than Target value + Set width.
condition (Conductivity of CD2 or CD4 is considered as the average of the conductivity
during filling of the chamber on the P1 side)
Automatically resets and restarts operation when both CD2 and CD4 become below
Reset Target value + Set width.
condition At this time, feedback control of P4 and P5 also restarts.
Note Stops feedback control of P4 and P5.
Not monitored when closed circuit is tested and when hydraulic line is stopped in SEQ-UF process.
0043 B+W CONDUCTIVITY LOWER LIMIT

Detecting CD2 or CD4 has become Target value - Set width or less.
condition (Conductivity of CD2 or CD4 is considered as the average of the conductivity
during filling of the chamber on the P1 side)
Automatically resets and restarts operation when both CD2 and CD4 become over
Reset Target value - Set.
condition At this time, feedback control of P4 and P5 also restarts.
Not monitored when closed circuit is tested or hydraulic line is stopped in SEQ-UF process.
0044 B+W CONDUCTIVITY CONTROL FAULT

Detecting ・Alarm 0042 or Alarm 0043 occurred 4 times consecutively.
condition ・Instantaneous value of CD2 or CD4 was less than 1.0mS/cm during Alarm 0043 occurs.
(Refer to Information 1000. )
Red blinks Beep ― ― ― ○ Setting ― Stop
condition
Note Back to dialysate NG state.
Use lower limit Setting Value if the value is less than 1.0mS/cm.
10-13
0045 SOLUTION B DIFFERENCE FAULT
Detection When dialysate is NG after preparation (Not monitored when testing closed circuit.)
Detecting ・30 secs. later after P4 starts, instantaneous value of CD2 or CD4 was less than 1.0mS/cm.
condition (Refer to information 1000.)
・100 secs. later after P4 starts (after end of sucking), average value of CD2 or CD4 was not within the
Target value ± Set width (When use B-Powder, count is 150 seconds.)
condition
Note "Average value" means the average conductivity value during filling in the chamber on the P1 side.
Target value - Set width uses Target value - Set width for a thing of less than 1.0mS/cm.
0046 TOTAL CONDUCTIVITY UPPER LIMIT

Detecting CD1 or CD3 has become Target value + Set width or more.
condition
Reset Automatically resets and restarts operation when both CD1 and CD3 become below
condition Target value + Set width.
At this time, feedback control of P4 and P5 also restarts.
0047 TOTAL CONDUCTIVITY LOWER LIMIT

Detecting CD1 or CD3 has become Target value-Set width or less.
condition
Reset Automatically resets and restarts operation when both CD1 and CD3 become over
condition Target value - Set width.
At this time, feedback control of P4 and P5 also restarts.
0048 TOTAL CONDUCTIVITY CONTROL FAULT

Detecting ・Alarm 0046 or Alarm 0047 occurred 4 times consecutively.
condition ・Instantaneous value of CD1-CD2 or CD3-CD4 was less than 1.0mS/cm during Alarm 0047 occurs.
(Refer to Information 1000. )
condition
Note Back to dialysate NG state.
The value is considered as the average of the conductivity during filling in the chamber on the P2 side.
10-14
0049 SOLUTION TOTAL DIFFERENCE FAULT
Detection When dialysate is NG after preparation (Not monitored when testing closed circuit.)
Detecting ・50 secs. later after P5 starts, instantaneous value of CD1-CD2 or CD3-CD4 was less than 1.0mS/cm.
condition (Refer to information 1001.)
・120 secs. later after P5 starts (after end of sucking), average value of CD1 or CD3 was not within the
Target value ± Set width (When use B-Powder, count is 180 seconds.)
condition
Note "Average value" means the average conductivity value during filling in the chamber on the P2 side.
0050 SOLUTION B CALIBRATION ERROR

Detection Start Preparation, Dialysate calibration
Control Section
Detecting The result of B dialysate calibration was not within B solution error range of set value.
condition
condition
Note
0051 SOLUTION A CALIBRATION ERROR

Detection Start Preparation, Dialysate calibration
Control Section
Detecting The result of A dialysate calibration was not within the range of set value.
condition
condition
Note
0068 Dia. Press2 (PG3) UPPER LIMIT

Detection Dialysis and Dialysis end (Not monitored when testing closed circuit.)
Detecting Pressure has exceeded Fix pressure + Upper width consecutively for 5 seconds.
condition
Red blinks Beep ― ― ― ― ○ ― ―
Reset Restarts operation by resetting alarm. At this time, set pressure alarm of PG3 free.
condition
Note Set pressure alarm of PG2, PG4-PG5, and PG6 free when alarm is output.
Release pressure.
10-15
0069 Dia. Press2 (PG3) LOWER LIMIT
Detection Dialysis and Dialysis end (Not monitored when testing closed circuit.)
Detecting Pressure has been lower than Fix pressure - Lower width consecutively for 5 seconds.
condition
condition
Release pressure.
0070 Dia. Press2 (PG3) MAXIMUM PRESSURE

Detection Always
Detecting Pressure has been at 700 mmHg or more for 5 sec. continuously.
condition
condition
Release pressure.
0071 Dia. Press2 (PG3) MINIMUM PRESSURE

Detection Always
Detecting Pressure has been at -550 mmHg or less for 5 sec. continuously.
condition
condition
Release pressure.
0072 A. Press (PG4a) UPPER LIMIT

Detection Dialysis, Dialysis end
Detecting Pressure has been (Fix pressure + Upper width) or more for continuously for 2 seconds.
condition
Red blinks Beep ○ ○ Venous line ― ○ ― ―
Reset Restarts operation by resetting alarm. At this time, set pressure alarm of PG4a free.
condition
Note Set pressure alarm of PG2-PG3, PG4b-PG5, and PG6 free when alarm is output.
10-16
0073 A.Press (PG4a) LOWER LIMIT
Detecting Pressure has been (Fix pressure - Lower width) or less for continuously for 2 seconds.
condition
Red blinks Beep ○ ○ Venous line Setting ○ ― ―
condition
0074 A. Press (PG4a) MAXIMUM PRESSURE

Detection Always
condition
condition
0075 A. Press (PG4a) MINIMUM PRESSURE

Detection Always
condition
condition
0076 Dia.Inlet Press (PG4b) UPPER LIMIT

Detecting Pressure has been (Fix pressure + Upper width) or more continuously for 2 seconds.
condition
Reset Restarts operation by resetting alarm. At this time, set pressure alarm of PG4b free.
condition
Note Set pressure alarm of PG2-PG4a, PG5, and PG6 free when alarm is output.
10-17
0077 Dia.Inlet Press (PG4b) LOWER LIMIT
Detecting Pressure has been (Fix pressure - Lower width) or less continuously for 2 seconds.
condition
condition
0078 Dia.Inlet Press (PG4b) MAXIMUM PRESSURE

Detection Always
condition
condition
0079 Dia.Inlet Press (PG4b) MINIMUM PRESSURE

Detection Always
condition
condition
0080 V. Press (PG5) UPPER LIMIT

Detecting Pressure has been (Fix pressure + Upper width) or more continuously for 2 seconds.
condition
condition
Note Set pressure alarm of PG2-PG4b, PG6 free when alarm is output.
Not monitored when SN/SP mode is used.
10-18
0081 V. Press (PG5) LOWER LIMIT
Detecting Pressure has been (Fix pressure - Lower width) or less continuously for 2 seconds.
condition
condition
0082 V. Press (PG5) MAXIMUM PRESSURE

Detection Always
condition
Reset Restarts operation by resetting alarm. At this time, set pressure alarm PG5 free.
condition
0083 V. Press (PG5) MINIMUM PRESSURE

Detection Always
condition
condition
0090 SN Press MAXIMUM PRESSURE

Detection Always in single needle (SN) mode
condition
condition
Note Set pressure alarm of PG2-PG5 free when alarm is output.
Monitored by using PG5 when SN/SP mode is used.
10-19
0091 SN Press MINIMUM PRESSURE
Detection Always in single needle (SN) mode
condition
condition
0092 SN STROKE TIME FAULT

Detection Dialysis and Dialysis end (in single needle (SN) mode)
Detecting Actual pressure did not reach switching pressure even after preset time passed.
condition
condition
0093 SN STROKE VALUE FAULT

Detecting Blood volume par stroke was lower than set value:
condition ･Obtain volume from the period that BP operates (suction time).
･Confirm when reaching lower limit pressure (when finishing discharge).
condition
0094 SN UPPER LIMIT

Detecting Pressure has been (Upper point + Upper width) or more continuously for 2 seconds.
condition
Reset Restarts operation by resetting alarm. At this time, set pressure alarm free once
condition until switching operation is done once.
10-20
0095 SN LOWER LIMIT
Detecting Pressure has been (Lower point - Lower width) or less continuously for 2 seconds.
condition
Reset Restarts operation by resetting alarm. At this time, set pressure alarm free once
condition until switching operation is done once.
0096 SN MAX VOLUME FAULT

Detecting The amount of blood sucked at BP has exceeded the set value.
condition ・The amount of blood is calculated as BP operation rate - UF Removed volume
Reset Restarts operation by resetting alarm. The alarm is set free until switching is completed.
condition
0100 FIND AIR BUBBLE

Detection Dialyzer rinse (during blood detecting), Dialysis, Dialysis end, and Retrans
Detecting Air bubble of 9.0 µL of more was detected.
condition
condition
0101 TOTAL BUBBLE OVER

Detecting Total value of Micro bubble is more than setting value within set time.
condition
Reset Restarts operation and resets counting bubbles by resetting alarm.
condition
10-21
0102 AIR BUBBLE SENSOR FAULT
Detection Always
Detecting A/D value was at 1.3 V (266) or more when test signal was output.
condition A/D value was at 0.5 V (102) or less when test signal was not output.
Test signal was not stopped for 5 msec. every sec. (only in the monitoring section.)
condition
0105 DETECT BLOOD

Detection Dialyzer rinse
Control section
Detecting Detect blood on bloodline.
condition
Reset Automatically restart operation if sensor detects other than blood.
condition
Note
0110 FIND BLOOD LEAK

Detection Dialyzer rinse (after filling), Dialyzer rinse end, Dialysis, Dialysis end, and Retrans
Detecting Blood leak more than set value was detected (not monitored for 1 min. after releasing bypass).
condition
Operation Lamp Sound BP stop 0 Clamp close Bypass UF stop Heater OFF Hyd. line stop
Red blinks Beep ○ ○ Venous line ○ ○ ― ―
condition
Monitor according to the parameter setting during dialyzer rinse mode.
0111 DIRTY BLOOD LEAK SENSOR

Detection Preparation, Preparation end, Dialyzer rinse (after filling), Dialyzer rinse end, Dialysis,
Dialysis end, and Retrans
Detecting Sensor rinse signal has turned ON for 5 secs. continuously.
condition (Ignore for 2 sec. after test signal was output.)
condition
Monitor according to the parameter setting during dialyzer rinse mode.
10-22
0113 DIRTY BLOOD LEAK SENSOR (ZEROLIZE ERROR)
Detection When zero adjustment for blood leak sensor is performed
Detecting Contamination signal turned ON during zero adjustment.
condition
condition
Note
0120 FLOW SWITCH 1 FAULT

Detection While P1 operates
Detecting ・FS1 did not detect flow even within 5 sec. after switching chamber.
condition ・FS1 did not detect flow in the rinse process.
Red blinks Beep ― ― ― ○ ○ ○ ○
condition
Note Outputs Information 1002 when this alarm is output.
0121 FLOW SWITCH 1 TIME OVER

Detection While P1 is operating （monitoring starts at the 4th chamber switch）
Detecting The speed of P1 was outside the range of Target flow rate (1000 ml/min) ± Set width
condition (the set width is included) 3 times consecutively.
(The speed of P1 is measured as the average speed for 2 chamber switches.)
Reset Automatically resets and restarts operation if it is within the range.
condition
Note Clears monitor timer and restarts monitoring when this alarm is output. Also, outputs Information 1002.
Not monitored while Alarm 0122 is output. Not monitored when testing closed circuit.

Detection Always (except when chambers are through, or testing closed circuit)
Detecting Outputs under the following conditions.
condition ･Alarm 0121 has occurred 3 times consecutively.
･Chamber filling time of FS1 has exceeded 30 sec. (exclude suction process).
･The speed of P1 has become 2 times or faster than the target speed.
condition
Note Resets Alarm 0121 and outputs Information 1002 when this alarm is output.
10-23
0123 FLOW SWITCH 2 FAULT
Detection While P2 operates
Detecting ・FS2 did not detect flow even within 5 sec. after switching chamber.
condition ・FS2 did not detect flow in the rinse process.
condition
Note

Detection While P2 is operating （monitoring starts at the 3rd chamber switch after feedback of P2 started)
Detecting The speed of P2 was outside the range of Target flow rate (1000 ml/min) ± Set width
condition (the set width is included) 3 times consecutively.
(The speed of P2 is measured as the average speed for 2 chamber switches.)
Reset If within the range, automatically resets and restarts operation.
condition
Note Clears monitor timer and restarts monitoring when this alarm is output.
Not monitored while Alarm 0125 is output.

Detection Always (except when chambers are through, or testing closed circuit)
Detecting Outputs under following conditions.
condition ･Alarm 0124 has occurred 3 times consecutively.
･Chamber filling time of FS2 has exceeded 90 sec.
condition
Note Resets Alarm 0124 when this alarm is output.
0130 AIR SEPARATOR FAULT

Detection While P2 operates or during dialysis process in SEQ-UF
Detecting Without Dialysis process: LS1 has detected air for 30 sec. continuously.
condition Dialysis process:
･Detect air for 10 seconds continuously
･Gas purge sequence operated for set times
Red blinks Beep ― ― ― ○ ○ ― ―
condition
Note Not monitored during drain process and 30 seconds after sucking disinfectant in the disinfection process.
Not monitored during FS1 does not flow.
10-24
0131 AIR SEPARATOR FAULT (Chemical tank is empty）
Detection First 30 seconds in the disinfection process
Detecting LS1 has detected air.
condition Value of CD3 did not reach setting value of disinfectant concentration
Reset (Automatically start temporary water rinse.)
condition Restarts operation by resetting alarm.
Note Temporally water rinse time is about 4 min,
0140 UF RATE FAULT

Detection While UF pump operates
Detecting Actual speed has been outside Target speed ± 0.1 L/h 3 times continuously.
condition
condition
Note
0141 UFP ENCODE FAULT

Detection Always
Detecting Either one of the following has occurred.
・Rotation pulses could not detect for specified time is differet depending on software version while
condition UFP operated.
- Ver.7.10 or before: 30 sec.
- Ver.7.11 or later: equivalent to 1.5 pulses
・3 pulses (2 or 3 turns) were reversed while UFP operated.
・3 pulses (2 or 3 turns) were detected while UFP stopped.
condition
Note
0142 UF RATE LIMIT OVER

Detecting UF speed has exceeded the alarm value (BP flow rate×Set rate) when BP flow rate is changed.
condition
Reset Automatically resets when UF speed becomes below alarm value.
condition
Note Not monitored when testing closed circuit.
10-25
0143 PROFILE CONDITION WARNING
Detection At beginning of profile execution
Detecting Execution time for 1 step is below 3 min.
condition
Red blinks Chime ― ― ― ― ― ― ―
condition
Note Sounds alarm at fixed interval until alarm is reset.
0150 TMP UPPER

Detecting Actual value has exceeded set value for 3 sec.
condition
condition
Note Not monitored while UF pump is stopped.
0151 TMP LOWER

Detecting Actual value has been below set value for 3 sec.
condition
condition
Note Not monitored while UF pump is stopped.
0160 SOLUTION A PORT OPEN

Detection Rinse, Forced rinse by water, feed water, UFP adjustment
Detecting Pipette of A concentrate is off.
condition
Red blinks Beep ― ― ― ― ― ○ ○
Reset Automatically resets when pipette is inserted.
condition
Note
10-26
0161 SOLUTION B PORT OPEN
Detecting Pipette of B concentrate is off.
condition
Reset Automatically resets when pipette is inserted.
condition
Note
0162 SOLUTION A PORT CLOSE

Detecting Pipette of A concentrate was inserted when standard dialysate was used.
condition
Reset Automatically resets when pipette is removed.
condition
Note Stops P5 when this alarm is output.
Sounds alarm at fixed interval until alarm is reset.
Not monitored when hydraulic line is stopped in SEQ-UF process.
0163 SOLUTION B PORT CLOSE

Detecting Pipette of B concentrate was inserted when standard dialysate was used.
condition
Reset Automatically resets when pipette is removed. At this time, also restarts P5 feedback control.
condition
Note Stops P4 and feedback of P5 when this alarm is output.
Sounds alarm at fixed interval until alarm is reset.
Not monitored when acetate is dialyzed or the hydraulic line is stopped in the SEQ-UF process.
0170 SET COUPLER ON HOLDER

Detecting Coupler was disconnected from machine.
condition
Reset Automatically resets when coupler is connected to machine.
condition
Note
10-27
0171 SET COUPLER ON HOLDER
Detection Preparation
Detecting Coupler was disconnected from machine.
condition
Reset Automatically resets when coupler is connected to machine.
condition
Note Sounds alarm at fixed interval until alarm is reset.
0172 SET COUPLER WITH DIALYZER

Detection Dialyzer rinse, Dialyzer rinse end, Preparation, Retrans
Detecting Either one of couplers was connected to machine.
condition
Reset Automatically resets when both couplers are disconnected, but keep manual bypass condition.
condition
Note Performs operations same as manual bypass when this alarm is output.
0180 B POWDER HOLDER OPEN

Detecting When the state other than without the Bicarbonate powder cartridge is detected during Bicarbonate
condition powder function.
Reset Automatically resets when the state become non Bicarbonate cartridge.
condition
Note
0181 NON B POWDER

Detecting When the state other than with the Bicarbonate powder cartridge is detected during use the Bicarbonate
condition powder function.
Reset Automatically resets when the state become with Bicarbonate cartridge.
condition At this time, restart the feed back control of P5.
Note Stop the P4, feed back control of P5 and close the V11 when this alarm.
Chime out regularly until reset this alarm.
Not detect when stop the hydraulic line duling ACETATE dialysis or SEQ-UF mode.
10-28
0182 SOLUTION B PORT OPEN
Detecting Unplug the B Solution nozzle during use the Bicarbonate powder or Central (B solution) function.
condition
Reset Automatically resets when plug the nozzle. At this time, restart the feed back control of P5.
condition
Note Stop the P4 and feed back of P5 when this alarm.
Not detect when stop the hydraulic line duling ACETATE dialysis or SEQ-UF mode.
0183 SOLUTION A PORT OPEN

Detecting Unplug the A Solution nozzle during use the Central (A1 or A2) function.
condition
Reset Restarts by resetting alarm.
condition
Note Stop the P5 and feed back of P4 when this alarm.
Not detect when stop the hydraulic line duling SEQ-UF mode.
0184 CENTRAL A1 VALVE OPEN

Detection Rinse
Detecting Detect valve V18 or V19 opening.
condition
condition
Note
0185 CENTRAL A2 ( or B) VALVE OPEN

Detection Rinse
Detecting Detect valve V12 or V17 opening.
condition
condition
Note
10-29
0201 CLV POSITION FAULT
Detection Always
Detecting Working condition (SW16) of venous clamp has been different from that in operated condition for 2 sec.
condition
condition
Note
0202 V12 MALFUNCTION

Detection ALWAYS
Detecting Operating condition of V12 has been different Control and Monitoring section.
condition
condition
Note When Central A2 or B is set to active.

Detection ALWAYS
condition
condition
Note When Central A2 or B is set to active.

Detection ALWAYS
condition
condition
Note When Central A1 is set to active.
10-30
Detection ALWAYS
condition
condition
Note When Central A1 is set to active.
0210 ARTERIAL BLOOD PUMP FAULT

Detection Always
Detecting Either one of following has occurred.
condition ・Rotation pulses could not be detected for 3 sec. while arterial blood pump operated.
・Roller was turned 1/2 turn or more while arterial blood pump stopped at the end of dialyzer rinse or
dialysis or dialysis end. (Ignore manual revolution.)
・Roller was turned reversely 1/2 turn or more while arterial blood pump stopped at end of dialyzer
rinse or dialysis or dialysis end. (Detect also manual reversal.)
Reset Resets operation by resetting alarm.
condition
Note
0211 ARTERIAL BLOOD PUMP TROUBLE

Detection While arterial blood pump operates.
Detecting Either one of following has occurred.
condition ･Error signal was detected.
･Excess driving current was detected.
condition
Note
0212 ARTERIAL BLOOD PUMP STOP

Detecting Arterial blood pump has stopped.
condition
Reset Automatically resets when arterial blood pump is driven.
condition
Note
10-31
0213 ARTERIAL BLOOD PUMP STOP
Detecting Arterial blood pump is stopped for the set time.
condition
Reset Automatically resets when arterial blood pump is driven.
condition
Note Resets Alarm 0212 when this alarm is output.
0230 HEPARIN LIMIT SW ON

Detection Always
Detecting Limit SW ON (overload) was detected.
condition
Red blinks Beep ― ○ ― ― ― ― ―
Reset Automatically resets when Limit SW turns OFF.
condition
Note
0231 HEPARIN RATE FAULT

Detection While syringe pump operates
Detecting Actual speed has been outside Target speed plus or minus 30 percentage 5 times continuously..
condition (Alarm range would be "Target speed plus or minus 0.2 mL/h", in case Target speed is
less than 0.7 mL/h speed.)
Reset Restarts operation by resetting the alarm.
condition
Note
0232 SYRINGE PUMP FAULT

Detection Always
Detecting Either one of the following has occurred.
condition ・TYPE 1-4 Machine: Rotation pulses could not be detected for 30 sec. while syringe pump operated.
・TYPE 5 Machine : Rotation pulses could not be detected for the time that is equivalent to 1.5 pulses
while syringe pump operated.
・1/4 turn was reversed while syringe pump operated, or detected while syringe pump stopped.
Reset Restarts operation by resetting the alarm.
condition
Note
10-32
No. 0300 ~ (BPM)
Refer to BPM Option Manual
0400 Kt/V value can not reach more than 2.0, for physiological reasons.
Detection When calculate the Estimated value
Control section
Detecting Estimated value of Kt/V was over 2.0.
condition
Reset Automatically resets when Estimated value of Kt/V was less than 2.0.
condition Or restarts operation by resetting the alarm.
Note Not alarms until recalculate the Kt/V Estimated value, after resetting the alarm.
Not beep until return the Rinse Standby screen, after second time.
10-33
0800-0803 T1-T4 TEST NG
Detection Startup test
Detecting When test output is ON:
condition T1-T4 values are outside the range of 40.1-63.1 ℃.
Reset Automatically resets when tested again.
condition
Note
0805 T6 TEST NG
condition T6 value is outside the range of 15.0-16.5 ℃.
condition
Note
0820-0823 CD1-CD4 TEST NG

condition CD1-CD4 values are less than 29.0 mS/cm
condition
Note
0830-0833 PG4a-PG6 ZERO TEST NG

condition PG4a values are outside the range of 0 ± 10 mmHg.
condition
Note
10-34
0840-0842 PG1-PG3 TEST NG
condition PG1-PG2 values are outside the range of ＋80 -＋125 mmHg.
condition
Note
0843-0846 PG4a-PG6 TEST NG

condition PG4a-PG6 values are outside the range of 250 ± 50 mmHg.
condition
Note
0860 BLD TEST NG

Detecting Failure in zero adjustment or in self diagnosis occurred during self diagnosis.
condition
condition
Note
0861 BLD ANALOG TEST NG

Detecting After self-diagnostic signal was output
condition AN-7727 : Analog value was outside the range of 3.0 ± 0.1 V.
HKE0221: Amount of analog value change was not 50% from value before test.
condition
Note
10-35
0870 BP1 TEST NG
Detecting Return pulse is outside the range 5000 - 8500 pulses.
condition
condition
Note
0872 UFP TEST NG

Detecting Difference of return pulse is outside the range 6 ± 1 pulses.
condition
condition
Note
0873 HP TEST NG
Detecting Difference of return pulse is outside the range.
condition ・TYPE 1 - 4 Machine : 60 ± 15 pulses.
・TYPE 5 Machine : 13 ± 1 pulses.
condition
Note
0881 CL2 TEST NG

Detecting Clamp did not open or close normally.
condition
condition
Note
10-36
0890 V02 TEST NG
Detecting Valve did not open or close normally.
condition
condition
Note
0891 V31 TEST NG

condition
condition
Note
0892 V32 TEST NG

condition
condition
Note
0893 V33 TEST NG

condition
condition
Note
10-37
0900 LEAK TEST NG
Detecting Leak occurred in either of the following: V21, V23, V25, V27
condition
condition
Note
0901 LEAK TEST NG

Detecting Leak occurred in either of the following: V22, V24, V26, V28
condition
condition
Note
0902 LEAK TEST NG

Detecting Leak occurred in the membrane of the chamber.
condition
condition
Note
0903 LEAK CHECK OVER TIME ERROR

Detecting Fluid pressure did not reach "TARGET PRESSURE" within "TARGET TIME." due to P1.
condition
condition
Note
10-38
0904 LEAK TEST NG (AT DIALYSIS)
Detection Dialysis
Detecting Big leak occurred in either of the following: V41, V42, V32, V33, V34
condition
condition
Note
0905 LEAK TEST NG (V31)

Detection Startup Test
Detecting Leak occurred at V31.
condition
condition
Note
0910 CF1 LEAK TEST NG

Detecting Leak occurred in closed circuit.
condition
condition
Note
0912 CF1 AIR FILLING TIME OVER ERROR

Detecting Air filling by P2 exceeded 2 minutes.
condition
condition
Note
10-39
0913 CF1 LEAK CHECK OVER TIME ERROR
Detecting Fluid pressure does not reach "TARGET PRESSURE" within "TARGET TIME" due to UFP.
condition
condition
Note
10-40
1000 SOLUTION B EMPTY
Detection
Detecting Alarm 0044 or Alarm 0045 was output, and the value of conductivity CD2 or CD4
condition was lower than 1.0mS/cm.
― ― ― ― ― ― ― ― ―
Reset Normal operation is restored by resetting alarm.
condition
Note
1001 SOLUTION A EMPTY

Detection
Detecting Alarm 0048 or Alarm 0049 was output, and the value of conductivity CD1-CD2 or
condition CD3-CD4 was lower than 1.0mS/cm
― ― ― ― ― ― ― ― ―
condition
Note
1002 CONFIRM WATER SUPPLY

Detection
Detecting Alarm 0063 or one of Alarms 0120-0122 was output.
condition Failure in water supply confirmation occurred.
condition
Note
1003 POWER OFF & CLEAN BLD

Detection
Detecting Alarm 0113 was output.
condition
condition
Note
10-41
1010 - 1019 RINSE STEP xx MISTAKE
Detection At beginning of rinse
Detecting Rinse program was checked before rinse began, and setting was incorrect.
condition
― Chime ― ― ― ― ― ― ―
condition
Note
1020 - 1029 RINSE STEP xx INCOMPLETE

Detection Rinse
Detecting ・Rinse time of each process did not reach minimum rinse time.
condition ・The value of PG3 becomes lower than 0mmHg for "n" times in the recirculation rinse process.
― Chime ― ― ― ― ― ― ―
condition
Note "n" =Recirculation rinse time / 1
1030 RINSE SOLUTION DIFFERENCE FAULT

Detection Rinse
Detecting The value of CD4 is outside the set range at 12 min. into disinfectant rinse process.
condition
― Chime ― ― ― ― ― ― ―
condition
Note
1040 ETRF LIFE LIMIT OVER

Detection When return to Rinse Standby screen
Detecting It has reached the limit operating hours or limit usage count.
condition
― Chime ― ― ― ― ― ― ―
Reset Automatically restored when the status of use is cleared after replacing ETRF.
condition
Note Not monitored without ETRF.
10-42
1050 UF RATE OVER
Detecting UF speed has exceeded the upper limit value (BP flow rate×Set rate).
condition
― Chime ― ― ― ― ― ― ―
condition
Note Does not change UF speed.
1051 UF RATE MAXIMUM

Detection Always
Detecting UF (ultrafiltration) speed has exceeded its maximum value.
condition
― Chime ― ― ― ― ― ― ―
condition
Note Does not change UF speed.
1060 CHANGE SOLUTION OF RINSE PORT1

Detection Rinse
Detecting Solution different from the previous solution was used to the rinse port 1.
condition
Reset Automatically resets when "CONTINUE" button is pressed.
condition
Note
1061 CHANGE SOLUTION OF RINSE PORT2

Detection Rinse
Detecting Different solution from the solution previously used was used to the rinse port 2.
condition
Reset Automatically resets when "CONTINUE" button is pressed.
condition
Note
10-43
1070 BLD OVERRIDE
Detection Dialyzer rinse, Dialysis, Dialysis end
Detecting When start the BLD Override function.
condition
― ― ― ― ― ― ― ― ―
Reset
condition
Note Display in Message History monitor only.
10-44
2000 RECOVERY FROM POWER FAILURE
Detection When powered ON, At power failure
Detecting When machine has recovered from power failure.
condition ・Includes the case when power supply is turned ON after power is OFF
during power failure process.
― Chime ― ― ― ― ― ― ―
condition
Note Refer to Alarm 0002.
2001 RINSE COMPLETE

Detection Rinse
Detecting Rinse program has completed.
condition
― Chime ― ― ― ― ― ― ―
Reset Automatically returns when operation changes from rinse end process to other process.
condition
Note
2002 UF COMPLETE
Detection Dialysis
Detecting Actual UF volume has reached target UF volume.
condition
Green Melody ― ― ― ― ― ― ―
condition
Note
2003 TREATMENT COMPLETE

Detection Dialysis
Detecting Treatment time became zero (0).
condition
Green Melody ― ― ― ― ― ― ―
condition
Note
10-45
2004 TREATMENT START
Detection Dialysis
Detecting Treatment has started.
condition
Green Chime ― ― ― ― ― ― ―
condition
Note
2005 TMP OFFSET AUTO CALCULATION

Detection Dialysis
Detecting TMP automatic offset operation has started.
condition
Green Chime ― ― ― ― ― ― ―
Reset Normal operation is restored when operation is completed.
condition
Note
2006 WAIT UNTIL STABLE OF COND AND TEMPERATURE

Detection Dialyzer rinse, Dialyzer rinse end, Dialysis, Dialysis end, and Retrans
Detecting During preparation of dialysate
condition
― Chime ― ― ― ― ― ― ―
Reset Normal operation is restored after the preparation of dialysate is completed.
condition
Note
2007 COMPLETION OF SYRINGE PUMP INFUSION

Detection Dialysis
Detecting Syringe pump has stopped automatically before the set time of treatment end.
condition
― Chime ― ― ― ― ― ― ―
condition
Note
10-46
2008 CHANGE CONDUCTIVITY
Detecting Electric conductivity has been changed.
condition
― ― ― ― ― ― ― ― ―
Reset
condition
Note
2010 DETECT SALINE

Detection Dialysis
Detecting Blood was substituted by saline solution.
condition
― Chime ― ― ― ― ― ― ―
condition
Note BP stop, HP stop, clamp close, bypassing, and UF stop are executed by setting.
2011 DETECT BLOOD

Detection Dialysis
Detecting Saline solution was substituted by blood.
condition
― Chime ― ― ― ― ― ― ―
Reset Normal operation is restored automatically, except for blood.
condition
Note
2020 AUTO PRIMING ACTIVE

Detection Priming
Detecting Priming has started.
condition
― Chime ― ― ― ― ― ― ―
condition
Note
10-47
2021 PRIMING COMPLETE
Detection Priming
Detecting Priming has completed.
condition
― Chime ― ― ― ― ― ― ―
condition
Note
2040 LIFE OF ETRF IS ALMOST OVER

Detection When return to Rinse Standby screen
Detecting The stats of use is reached reminder value (Percentage for Replacement Reminder).
condition
― Chime ― ― ― ― ― ― ―
Reset
condition
Note Not monitored without ETRF.
2042 ETRF Use information has been reset

Detection Always
Detecting When activate ETRF option ot reset the ETRF use information by REPLACE button.
condition
― Chime ― ― ― ― ― ― ―
Reset
condition
Note
2050 WEEKLY RINSE START

Detection Rinse
Detecting At beginning of weekly rinse.
condition
― ― ― ― ― ― ― ― ―
Reset
condition
Note
10-48
2051 - 2055 RINSE xx START
Detection Rinse
Detecting At beginning of rinse.
condition
― ― ― ― ― ― ― ― ―
Reset
condition
Note
2060 - 2069 RINSE STEP xx SKIPPED

Detection Rinse
Detecting At skip of rinse.
condition
― ― ― ― ― ― ― ― ―
Reset
condition
Note
2100 POWER ON
Detection
Detecting When turning on power supply.
condition
― ― ― ― ― ― ― ― ―
Reset
condition
Note
2101 POWER OFF

Detection Rinse standby, Rinse end
Detecting When turning off using power SW.
condition
― ― ― ― ― ― ― ― ―
Reset
condition
Note
10-49
2102 ALARM RESET
Detection Always
Detecting Alarm reset SW is pressed.
condition
― ― ― ― ― ― ― ― ―
Reset
condition
Note
2103 B-POWDER WAS ATTACHED

Detection Always
Detecting In spite of the option setting of the B-Powder holder is "UNUSE", the machine detect it.
condition (When turn on the SW1 or SW2, detect it.)
― ― ― ― ― ― ― ― ―
Reset
condition
Note Change the option setting of the B-Powder to "USE" automatically.
2104 The programmed remaining time has been reached

Detection Always
Detecting The setting Remaining Time has reached.
condition
Blue blinks Chime ― ― ― ― ― ― ―
Reset
condition
Note Notice number of setting times (Initial setting: 5 times).
10-50
11 DAILY MAINTENANCE
After use of the machine, be sure to perform cleaning and disinfection to maintain its
performance for a long period of time.
11.1. Machine Enclosure

11.1.1. Cleaning and disinfection of enclosure
CAUTION
Do not use the following chemical solution.
These chemicals causes a damage of coating and solvent cracking.
- Alcohol disinfections (Ethel alcohol, Isopropyl alcohol)

- Organic solvent (Thinner, Benzene, etc.)
- Antiseptic solution and antimicrobial that contains quaternary ammonium salt
(Alkyldimethylbenzylammonium chloride, Didecyldimethylammonium chloride etc.) and/or some
kind of additive (N, N-Dimethylstearylamine etc.).
CAUTION
Do not use high concentrations or large amounts of disinfectant.
Chemicals such as Sodium hypochlorite, etc. are resolved and generate chlorine. Chlorine is a
harmful substance to the human body and also gives a serious damage to the parts or the
electrical system, making the machine defective.
CAUTION
Carefully clean and disinfect the venous and arterial pressure connection ports to prevent the
cross infection between patients.
However, take sufficient caution so that any liquid does not enter the ports of the venous and
arterial pressure sensors. Otherwise, the sensors may be damaged.
For cleaning, wipe off the machine enclosure with a squeezed soft cloth which is wet with
lukewarm water. Then remove moisture with soft dry cloth.
For disinfection, if blood adheres to the machine enclosure, wipe it with disposable paper
towel or cloth, and then wipe the part with 1000 ppm (0.1%) sodium hypochlorite. In a
moment, wipe the part with a squeezed soft cloth which is wet with lukewarm water,
remove moisture with soft dry cloth.
11.1.2. Cleaning of dialysate concentrate nozzle and rinse port

By using the machine for a long time, the nozzle and the port will become unsanitary by
the deposition of the dissolved objects of the concentrate, and the machine alarm related
with the nozzle may occur.
Regularly clean the dialysate concentrate nozzle and the rinse port with a squeezed soft
cloth which is wet with lukewarm water, remove moisture with soft dry cloth.
11-1
11.1.3. Cleaning of the touch panel
When cleaning the operation touch
panel with the power on, use the
function that disables the touch panel
operations temporarily. When
pressing the pointed part (at the
upper right corner of the window
shown in the figure) for several
seconds, the icon indicating
“operation disabled” appears.
Inputs from touch panel are disabled
while the icon is displayed, and
cleaning can be performed.
The disabled operations are
activated when pressing the icon
again after the completion of
cleaning.
NOTE
This function is deactivated automatically if an alarm occurs or after 3 minutes passes.
11.2. Cleaning and Disinfection inside Machine

Confirm that the power supply is OFF before cleaning or disinfecting inside the machine.
(a) Wipe off the dirt in the hydraulic line inside the machine inside with a cloth wet with
water.
(b) Immediately wipe off the concentrate adhered on the hydraulic line.
(c) Never touch any parts except the hydraulic line.
NOTE
Before opening the front door for cleaning and disinfection, confirm the power is turned OFF.
DANGER
It is very dangerous to clean the electric circuits of the machine. Do not allow any persons other
than the qualified to open the electric circuit cover.
11-2
11.3. Maintenance and Inspection
The operator needs to check the following points to make sure that the machine is in a
good condition before and after the daily use.
1. No water is spilt on the floor to prevent an electric shock and/or falling.
2. Hoses for water supply and drainage have no flaw, damage, fold, etc.
3. Hoses are properly connected to the water supply inlet connector and the drainage
outlet connector.
4. The power plug is properly connected.
5. No foreign matters such as medical solution and disinfectant are adhered on the
outer surface of the machine.
6. The machine passes all the start-up tests without causing any trouble performed
when the power ON/OFF switch is turned ON or the dialysis preparation process
begins.
Detailed information on the maintenance of machine is described in the Maintenance

Manual.
Maintenance of the machine must be performed only by the persons who have received
the training of machine provided by the manufacturer and sufficiently mastered the skills
and expertise.
11-3
12. OPERATION OF MACHINE
12.1. Operation in Screen
This machine features a touch panel display. When an intended portion to input data is
touched, a numerical keypad or a keyboard appears on the display.
1. To input a data, touch an

intended portion to display
the numerical keypad or the
keyboard on the screen.
2. After a numeral is input, press the ENTER key. The input

value is entered to the machine.
Press the ESC key to delete the keypad or the keyboard and
return to previous screen.
3. If the settable value is limited such as dialysate flow

rate, the input window as the figure (on the left) appears.
Raise and lower the set value by pressing the arrow
keys. After setting, press the [ESC] button to close the
window.
12-1
4. Input on Flow rate setting of blood pump, it is
possible to input by touching a bar graph
intuitively.
NOTE
This machine has the function to disable the touch panel operations temporally. By pressing
the gray part (the upper right corner) for several seconds, the icon appears as in the figure
below, and any operations on the touch panel are disabled. When any key operations are
not accepted, make sure that the icon (pointed with the arrow in the figure below) is not
displayed.
12-2
12.2. Screen Display Configuration
The following figure shows the information displayed on the screen.
No. Name Description
Dialysis operating Graphically displays the arterial pressure and the

1 condition display venous pressure in the dialysis process to monitor the
area dialysis operating condition.
Either one of the temperature, the conductivity, the TMP
Machine condition
2 (transmembrane pressure), the arterial pressure, the
display area
venous pressure, etc can be selected and displayed.
Process selection
3 Displays the start button for the next operation.
button display area
4 Alarm display area Displays the alarm contents if some alarm is triggered.
Blood pump / syringe

Displays the operating condition of each pump when the
5 pump operation
heparin pump and the blood pump are operating.
display area
UF volume operation Displays the condition of the UF (ultrafiltration)
6
display area operation.
12-3
No. Name Description
Rinse operating Graphically displays the arterial pressure and the

7 condition display venous pressure in the dialysis process to monitor the
area dialysis operating condition.
Operator mode
8 Displays the current operator mode. (See Chapter 12.3)
display area
12-4
12.3. NURSE Mode and TECHNICIAN Mode
For the purpose to insure safety, this dialysis machine classifies its operators into three
categories, NURSE, TECHNICIAN, and MAKER, according to the levels of necessary
operations. The TECHNICIAN mode is a mode used by a qualified person for the daily
maintenance and the MAKER mode is a mode to be used by the manufacturer of this
machine.
Never allow any person other than a qualified to operate in the TECHNICIAN mode.
CAUTION
An incorrect parameter, if set for an item changeable in the TECHNICIAN mode, may cause
serious damage on the health of a patient as well as damage on the machine.
How to enter the TECHNICIAN mode

1. Touch “NURSE” displayed at the upper right portion in a screen to open the following
screen.
2. Select an intended mode (TECHNICIAN or MAKER) to enter, input the PASS I.D. with
the numerical keypad, and press the ENTER key.
3. If the PASS I.D. is correct, the display of “NURSE” changes into red, “TECHNICIAN” is
displayed, and the mode changes to the TECHNICIAN mode.
4. The NURSE mode is restored if “TECHNICIAN” is touched again. The NURSE mode
will be automatically restored in 5 minutes if no input is made in the TECHNICIAN
mode.
12-5
12.4. Process Flowchart
Breaker ON
Stand by
POWER ON Confirmation
& Correction
CPU
Startup test
NG
OK
Rinse process standby
POWER OFF RINSE
Rinse process
End Preparation standby
POWER OFF PREP Confirmation

& Correction
Breaker OFF
Startup
test
NG
OK
Preparation
Dialysis process standby
DIALYSIS
Dialysis process
Dialysis completes.
12-6
13 RINSING AND DISINFECTING THE SYSTEM
WARNING
The setting of rinsing and disinfecting the system of the machine must be done only by the
persons who have received the training of this machine provided by the manufacturer and
sufficiently mastered its skills and experience.
13.1. Recommended Disinfection Method to Machine
WARNING
Disinfect the dialysate line every time after the dialysis treatment is complete. If the disinfection is
not performed sufficiently, it allows the growth of bacteria and virus in the machine. This is a risk
of contamination to the patients, if bacteria or virus enter the patient’s blood during the dialysis
treatment. There is possibility of threatening his or her life.
13.1.1.Concentration of disinfectant
Disinfection by sodium hypochloride, peracetic acid or high-temperature citric acid is
recommended with the machine.
Original disinfectant concentrations to be supplied to the machine are as follows.
 Sodium hypochloride: 4-6%
 Peracetic acid: 6%
 Citric acid: 50%
Check the concentration labeled on the container of the disinfectant and dilute it to the
above-mentioned concentration, if necessary.
CAUTION
When a disinfectant concentration lower than a above-mentioned value, satisfactory disinfection
efficiency will not be obtained.
CAUTION
Some disinfectant is added hydrogen peroxide solution. High concentrate of this additive may
cause of damage to the material of hydraulic line of the machine.
Before use disinfections, please confirm hydrogen peroxide solution make up no more than 8%.
13-1
NOTE
• When a disinfectant concentration exceeding the above-mentioned value is used, the
material in the hydraulic line of the machine may be damaged.
• Use the water suited for the dialysis to dilute the chemical.
• Do not leave the chemical container connected with the machine for a long time. It is
foreseeable that the concentration of the concentrate changes due to the evaporation of the
acetic acid, spoiling the efficiency.
13.1.2.Diluted concentration and disinfection time

The methods of the disinfection recommended with the machine are as follows setting.
 Sodium hypochloride: Dilution concentration: 1000ppm; Time: 30 min or more
 Peracetic acid : Dilution concentration: 1000ppm; Time: 30 min or more
 High-temperature citric acid : Dilution concentration: 3%; Time: 30 min or more
WARNING
When the dilution concentration or the disinfection time of the disinfectant is below the
above-mentioned value, it is foreseeable that bacilli multiply in the machine, threatening the
patient’s life.
13.1.3.Confirmation of residual disinfectant
WARNING
The residual disinfectant existed in the machine may threaten the patient’s life.
Always rinse the machine with water at least for 30 minutes after the disinfection is complete.
Check that no disinfectant remains in the machine by using the test paper or the reagent.
13.2. Removing Calcium from Dialysate Line
NOTE
Calcium carbonate deposits are adhered to the inside of the machine when the bicarbonate
dialysate is used. Bacteria are likely to grow if deposits are adhered, and causing malfunction of
the machine. Remove calcium at least once a week, except when peracetic acid is used.
13-2
13.2.1.Chemical to be used
The chemical to be supplied to the machine is acetic acid of 30-50% in concentration.
Dilute the chemical to the above-mentioned concentration if necessary, checking the
concentration labeled on the container of the chemical.
CAUTION
When a concentration lower than the above-mentioned value is used, sufficient efficiency of
calcium carbonate removed will not be obtained.
NOTE
When a concentration exceeding the above-mentioned value is used, the material in the
hydraulic line of the machine may be damaged.
Use the water suited for the dialysis to dilute the chemical.
Do not leave the chemical container connected with the machine for a long time. It is foreseeable
that the concentration of the concentrate changes due to the evaporation of the acetic acid,
spoiling the efficiency.
13.2.2.Confirmation of residual chemical
WARNING
The residual chemical existed in the machine may threaten the patient’s life.
Always rinse the machine at least for 30 minutes after acid cleaning. Check no chemical remains
in the machine by using the test paper or the reagent.
13-3
13.3. Rinse / Disinfection Process
1. First of all, confirm the following points.
• Blood circuit is removed.
• Each dialyzer coupler is correctly connected to the dialyzer coupler holder.
• A and B concentrate nozzles are correctly connected to the machine.
2. Turn ON the breaker at the rear of the machine, and then press and hold the
power ON/OFF switch for a while to start the machine.
3. When the rinse program is only WATER or HOT WATER, disinfectant nozzle is not
required bottles need not to be set. For other rinse program, put the disinfectant
nozzle at the rear of the machine into the disinfectant / chemical bottle prior to start the
rinse program.
Refer the table below.
Table 1 Disinfectant Used For Disinfection Rinse
Rinse program Disinfectant to be set Disinfectant nozzle color.
WATER Unnecessary Unnecessary
HOT WATER Unnecessary Unnecessary
CITRIC ACID Citric acid Yellow

SODIUM
Sodium hypochloride Yellow
HYPOCHLORITE
PERACET ACID Peracetic acid Yellow (*)
HOT CITRIC ACID Citric acid Yellow
ACETIC ACID Acetic acid Yellow (*)
DWELL - -
(*) If the machine has nozzle for concentrate option, set Orange colored nozzle.
13-4
4. Select an intended RINSE No. to perform on the RINSE STANDBY screen.
5. Confirm the displayed rinse process.

6. Press the RINSE button for 2 seconds. When an electric sound is heard, the rinse
operation process begins.
7. When selected rinse program is complete, the screen displays the RINSE STANDBY
screen again automatically.
8. If performed process was disinfection program, the indication yellow lamp and the
PREP button blink.
After software Version 7.20, the time of Last Disinfectant is shown in screen.
It was recorded at end of Disinfectant process in a rinse program.
NOTE
If AUTO POWER OFF function is enabled, the power supply will be turned off automatically
when the rinse program is complete.
13-5
NOTE
For the setting of the rinse program, refer to the Maintenance Manual.
An incorrect setting of the rinse program may cause serious damage to the health of the patient
as well as damage to the machine. Do not allow any persons other than the qualified to set the
rinse program.
NOTE
After Weekly Rinse Program was completed, the WEEKLY RINSE button turned yellow and the
machine does not accept to start another Rinse Program again preventing from wrong operation.
To start another Rinse Program again, press WEEKLY RINSE button once.
Then the button turns orange, displayed today’s Rinse Program, and is able to start another
Rinse Program.
13-6
14 USING OF THE MACHINE
14.1. Preparation Before Turning ON Power Supply Breaker

(Preparation Before Operation)
Check the following points before turning ON the power supply breaker. If any problem is
found, remove the cause immediately. Do not operate the machine unless it is solved.
• The power cable is correctly connected to the proper power source.

• Ground connection is correct.
• The water supply hose is correctly connected to the water supply port.
• The drain hose is correctly connected to the drain outlet.
• There is no folding or damage to the water supply hose and the drain hose.
• There is no inflammable liquid or substance around the machine.
DANGER
During the dialysis treatment, the patient may suffer from unexpected side effects such as
decrease in blood pressure, convulsion, nausea, or vomiting. Always observe the condition of
the patient. If any abnormality is found, take appropriate measures.
Refer to package inserts of used dialysate and dialyzers.
DANGER
Take extreme care to prevent patient-to-patient transmission when performing the dialysis
treatment.
CAUTION
To avoid infection transmission among patients, ensure to rinse and disinfect the system before
treatment.
14-1
14.2. Turning ON the Power Supply Breaker
1. Turn ON the power supply breaker.
The power lamp turns ON.
2. Make sure that the power lamp is ON. Press the power ON/OFF switch for 3 seconds
or more to turn ON the power.
The lamp of the power ON/OFF switch turns ON with electronic sounds, and the
RINSE STANDBY screen appears after the Startup screen.
DANGER
Ensure to rinse inside the fluid circuit before dialysis. Check if no residual disinfectant is present.
14-2
14.3. Dialysis Preparation Process
14.3.1.Setting of dialysate
1. Press the vicinity of "CONC.A" "CONC.B" at the lower right portion in the screen to
open the CONDUCTIVITY SETTING screen.
2. Press USE button for a while to select an intended dialysate No.. The button turns
yellow and checks the conductivity setting. If the setting is collect value, press the
EXIT button to return to the previous screen.
14-3
14.3.2.Preparation of dialysate
Prepare the dialysate selected in the previous section.
CAUTION
Make sure that there is a sufficient quantity of solution for a complete dialysis.
CAUTION
Make sure again that the selected solution of correct composition will be used. The use of the
solution of incorrect composition may cause serious damage to the health of the patient as well
as the preparation of dialysate of incorrect composition.
CAUTION
Do not use acetate dialysate concentration as acid concentration.
And do not use bicarbonate dialysate as acetate dialysate concentration.
14-4
14.3.2.1 When using acetate dialysate
1. Press the button shown in the
right figure on the
concentrate nozzle with white
marking to release the lock.
While pressing it, pull out the
nozzle in the direction of .
2. Put the nozzle in the tank of

acetate dialysis solution.
Nozzle for acetate
(red/white)
Set acetate dialysate concentrate (Not used)

as shown in the figure below.
Nozzle with red/white

marking (upper)
Acetate dialysis
solution
14-5
14.3.2.2 When using bicarbonate dialysate
1. Press the button shown in the
right figure on the
concentrate nozzle with red
marking to release the lock.
While pressing it, pull out the
nozzle in the direction of .
2. Put the nozzle in the tank of

A-solution.
3. Put the nozzle with blue Nozzle for A-solution

marking in the tank of (red/white)
B-solution in the same way as
the nozzle with red marking.
Nozzle for B-solution
(blue)
NOTE
Set bicarbonate dialysate concentrate as shown in the figure below.
Nozzle with blue Nozzle with red/white

marking (lower) marking (upper)
Bicarbonate dialysis Bicarbonate dialysis

solution solution
(B-solution) (A-solution)
14-6
14.3.3.Setting dialysis operation
1. Press and hold the button indicated by the arrow in the figure below for a while to
display the setting.
2. Select the operation mode. DIAMAX can select some operation modes below.
Double Needle
DN / SP Double Needle operation with Single Blood Pump
Single Pump mode
Single Needle
SN / SP Single Needle operation with Single Blood Pump
Single Pump mode
SN / DP Single Needle Single Needle operation with Two Blood Pumps
(Option) Double Pump mode and clamps
To activate desired operation mode, press and hold the button indicated by the arrow in
the figure below.
14-7
And confirm that the displayed setting is correct, press the EXIT button to return to the
previous screen. In case of the wrong setting, press the value to display the ten-key pad
and input the correct value.
NOTE
Setting about Single Needle Operation, please refer Chapter 15 SINGLE NEEDLE OPERATION.
14-8
14.3.4.Dialysis preparation process
Press the PREP button for a while to start the dialysis preparation.
Press the button for two seconds. When an electronic sound is heard, the operation for the
dialysis preparation process begins.
NOTE
If the machine has not completed the Disinfection Process after a certain period of time, the
machine gives information about disinfection.
After completing the startup tests successfully, the dialysis preparation screen will
appear, and the dialysis preparation operation (PREPARATION) starts.
At this time, confirm that the indication lamp (yellow and green) blinks.
14-9
CAUTION
The dialysis preparation mode may not start due to a sensor error in the startup test when the
bloodline is connected to the arterial pressure and venous pressure connection ports. When
the sensor error is detected, remove the bloodline that is connected to these ports following the
startup test. Press RETRY and repeat the startup test.
3. When pressing the

magnifying glass icon,
different information as
the table below can be
displayed. The display
changes in the order of
the table below at every
pressing. Maximum of 3
items can be displayed in
the window.
1 (Blank) NO INFORMATIION
2 CONDUCTIVITY Conductivity of dialysate (mS/cm)
3 TEMPERATURE Dialysate Temperature (°C)
4 DIA.PRESS Dialysate pressure (mmHg)
5 BLOOD LEAK Blood leak (ppm)
6 DIA.FLOW Dialysis flow rate (mL/min)
7 TBV Treated Blood Volume (mL)
8 Current Kt/V Current value of Kt/V
9 TREAT.TIME Treatment time
10 UF FIN TIME. UF (ultrafiltration) remaining time
11 TMP Transmembrane pressure (mmHg)
12 UFRC Kuf
13 V. PRESS Bloodline venous side pressure (mmHg)
14-10
14.3.5.Preparation of bloodline and dialyzer
DANGER
Ensure to use the bloodline compatible to the system. Use the other bloodlines can cause of
damage to the bloodline and serious harm to the patient.
1. Part names of bloodline set panel
No. Part names Remarks
1 Dialyzer Inlet Press Connection port Option
2 Arterial Press Connection port
3 Blood Pump 1
4 Arterial drip chamber set position (Pre-Pump)
14-11
No. Part names Remarks
5 Syringe Pump
6 Surface adjustment switch for Arerial drip chamber Option
7 Venous Pressure Connection port
8 Dialyzer Inlet drip chamber set position
9 Surface adjustment switch for Dialyzer Inlet drip chamber Option
10 Venous drip chamber set position
11 Surface adjustment switch for Venous drip chamber
12 Venous clamp unit (This unit Includes Air bubble detector)
2. Preparing the bloodline
DANGER
To prevent the contamination of the machine or infection, use a hydrophobic filter to connect to
any pressure connection ports.
DANGER
Improper connection to the bloodline may cause serious damage to the health of the patient.
Confirm again that the bloodline is correctly set.
DANGER
Set the air bubble sensor in the appropriate position to avoid air bubble goes into a patient.
CAUTION
Read the instruction for use of the bloodline carefully before use.
In software version 7.21, added the diameter setting button in NURSE mode (Treatment Data
screen and Treatment Mode).
Open the TREATMENT DATA screen from Main screen, or TREATMENT MODE screen by
operate MENU -> NURSE -> TREATMRNT and press TREATMENT MODE.
14-12
Keep press the button of Usage tube diameter (8.00mm or 6.35mm).
Need to confirm and adjust the pump rotor corresponding to pump segment diameter.
The rotor gap adjustment and calibration method is described in Maintenance Manual.
Press OK button on the popup window after confirmation, and Return to main screen by press
EXIT button.
NOTE
Recommend to prepare the spare rotor that adjusted to other gaps.
CAUTION
Combine correctly settings of rotor gap, software setting and tube dimension.
If set incorrect combination, the blood pump flow may become unintended volume.
14-13
During BP operation, selected dimension is possible to check on BP Operation Display
8.00mm 6.35mm
Reference: Procedure to set bloodline to the Blood Pump

1) Open the Blood Pump cover.
2) Clamp the upstream of Pump segment with Tubing Clamp A (See Figure 1).
3) Put the tube to the Tube Guide of Blood Pump, and rotate rotor by hand to the direction of
clockwise carefully (Figure 2).
4) Rotate rotor to the direction of clockwise not to nip tube carefully (Figure 3-4).
5) Set the Pump segment of bloodline, and then clamp the downstream of it with the Tubing
Clamp B (Figure 5).
6) Close the Blood Pump cover.
Tube Guide
Tubing Clamp A
Figure 1 Figure 2 Figure 3
Tubing Clamp B
Figure 4 Figure 5
14-14
Reference: Procedure to set bloodline to the Venous clamp Unit
1) Open the lid of Venous Clamp Unit.
2) Set the bloodline to the Venous Clamp Unit correctly (See Figure 6).
DANGER
Venous Clamp Unit includes Air Bubble detector, BD Sensor, and Venous Clamp. So improper
setting of bloodline causes of the serious damage to patient. Please be careful and not to kink or
bite the tube.
3) Close the lid until a snap sound is heard. Be careful not to bite the tube.
Air Bubble Detector
BD Sensor
Venous Clamp
Bloodline
Figure 6
To Patient
14-15
Observe the following procedure when preparing the bloodline.
(This section describes the method to prepare the bloodline using the NIPRO’s bloodline
(Type No. A121/V691).)
1) Open the blood pump cover and set the tube for the blood pump in the arterial
side bloodline to the blood pump by turning the rotor by hand along the red line on
the bloodline set face. Close the blood pump cover (Please see “Reference:
Procedure to set bloodline to the Blood Pump” above.).
2) Connect the pressure monitor line attached at the arterial drip chamber
(PRE-PUMP side) on the blood pump upstream side to the arterial pressure 1
connection port along the red line on the bloodline set face.
3) Set the drip chamber on the downstream side of the blood pump (POST-PUMP
side) to the correct position along the red line on the front door surface, and fix the
chamber with a tube holder.
4) Set the drip chamber of the venous side bloodline to the correct position along the
blue line on the front door surface, and fix the chamber with a tube holder.
5) Connect the pressure monitor line attached at the venous drip chamber to the
venous pressure connection port.
6) Open the door of the venous clamp unit, set the main line tube on the downstream
side of the drip chamber set in the step 4) to the venous clamp, and then firmly
close the lid until a snap sound is heard.
7) Set the arterial and venous main line tube to the tube holder along the red
(arterial)and blue (venous) line on the front door surface.
3. Connecting the dialyzer with the bloodline
DANGER
Performing low ultra filtration using a high-flux type dialyzer can cause back filtration.
a) Place the dialyzer holder with a dialyzer as blue coupler is placed upper position.
b) Connect the bloodline of arterial side to the arterial side of the dialyzer.
c) Connect bloodline of the venous side to the venous side of the dialyzer.
14-16
4. Setting the syringe pump for injecting the blood anticoagulant
a) Confirm that the flow rate setting of the syringe in the screen. Display the syringe
pump by pressing the syringe icon of the arrow shown below.
b) Confirm that the setting of the syringe pump is correct. If it is not correct, display
the ten-key pad by pressing the intended setting items and input appropriate value.
NOTE
The syringe size is be able to change in nurse mode from Software version 7.21.
Set the syringe length and confirm the infusion volume before use.
See chapter 7 and 15 in the Maintenance Manual.
14-17
CAUTION
If use this without setting and calibration, it may infuse wrong volume.
c) Remove air bubbles by pressing the pressing rod of

the syringe.
d) Release the lock by pressing the a lever of the

pusher to move the pusher to a suitable position.
e) Insert the pressing rod of the syringe into the slit of the pusher, and set the syringe
to the syringe pump. At this time, if the position of the pusher shifts from the
pressing rod of the syringe, release the lock again with a lever and set the pusher
to the appropriate position.
CAUTION
The 10 mL syringe pusher might be possible to hold the pressing, because part of it is slender
than holding part. Make sure that the pump can hold it correctly before using of this machine.
f) Fix the syringe by rotating the syringe

guard.
g) Connect the heparin line in the bloodline along the green line on the bloodline set
face.
h) Confirm that the above procedure has done correctly.
14-18
Reference: Bloodline layouts
From Patient Art.
To Patient Vein.
Figure: Bloodline Layout for Single Pump
14-19
14.3.6.Priming
1. Connect the arterial patient connector with the saline solution bag.
2. Connect the venous patient connector with the waste fluid bag.
3. Press the PRIMING button displayed in the screen.
Priming can be performed in the preparation process, not only after the rinse process is
completed.
When performing start up test of dialysis preparation operation, release the arterial
pressure connection port and venous pressure connection port
4. Check the priming volume and the flow rate. If the set values are inappropriate,
display the ten-key pad by pressing the numeral portion and then input appropriate
priming volume and priming flow rate.
14-20
5. Press the PRIMING button. The priming starts by the preset flow rate, and the pump
stops when ACCUMULATE VOLUME has reached the preset volume, completing the
whole priming process.
Confirm no bubbles in the bloodline and the dialyzer.
6. When the priming has been confirmed, Press the EXIT button to return to the previous
screen.
14-21
14.3.7.Dialyzer rinse
1. When the messages, "Connect BLUE-COUPLER" and "Connect RED-COUPLER"
appear on the screen after the dialysis preparation begins. Temperature and
conductivity are coming to within the alarm limits.
2. Open the Rinse of Dialyzer Setting screen by operate in order to Menu > Nurse ->
Treatment -> Rinse of Dialyzer.
3. Check the setting of Rinse time and Flow rate.
RINSE OF USE: Rinse the Dialyzer by below setting time and UF rate
DIALYZER UNUSE: Does not rinse the Dialyzer. Go to END OF DIALYZER
RINSE process after dialyzer filling.
RISNE TIME Setting of Dialyzer rinse time
UF GOAL Total ultrafiltration volume during Dialyzer rinse
In case of setting to “0 (L)”, only pass flow the dialysate into
dialyzer.
UF RATE UF rate information during Dialyzer rinse
This value is calculated from RINSE TIME and UF GOAL.
When this value is over the “UF RATE LIMIT”, the letter color
become to red.
UF RATE LIMIT Limitation of UF RATE setting.
If UF RATE value is more than UF RATE LIMIT, UF Pump moves
by UF RATE LIMIT value.
NOTE
In software version 7.30 or before, the UF pump rate change depending on Rinse time and
remove value setting.
14-22
4. First, connect blue coupler to the dialyzer, and then connect red coupler correctly.
NOTE
Be sure to connect blue coupler to the dialyzer first. Then the sequence reducing spilling water
from dialyzer coupler holder starts
5. Turn the dialyzer holder with a dialyzer as blue coupler is placed lower position.
6. The RINSE OF DIALYZER button blinks when both the red and blue couplers are
connected to a dialyzer. Here, confirm that both couplers are correctly connected, and
then press the blinking RINSE OF DIALYZER button.
Press and hold the button for two seconds. When an electronic sound is heard, the
operation for the dialyzer rinse begins.
NOTE
The flow rate of dialysate falls automatically at dialyzer rinse.
NOTE
It may occur dialysate pressure lower limit alarm.
14-23
7. Firstly, the dialysate begin to flow to the dialyzer for filling.
In case of the Blood pump stops, start the blood pump by pressing the pump1
ON/OFF switch.
CAUTION
In case of using machine with software version Ver.7.30 or before, the message “ Connect
patient” is displayed during Rinse of Dialyzer process.
However, the rinse is not enough and not appropriate for the treatment at this time.
Please do not connect the blood circuit to the patient.
The information is changed to “Press the connect Button, then Connect Patient” from Software
version 07.40.
8. After 25 secs., start diayzer rinse process automatically.
In case of the RINSE OF DIALYZER setting is set to “UNUSE”, move to END OF

DIALYZER RINSE process without dialyzer rinse.
Similarly, forcibly move to END OF DIALYZER RINSE process when detect blood.
NOTE
The remaining time of Filling dialyzer and Dialyzer rinse is shown in INFORMATION area since
software version 7.20.
In addition, remaining time and UF removed value is shown in information area during Dialyzer
Rinse process. About (UF) removed value, in case of that the UF pump moves UF RATE LIMIT
setting due to set too high rate, the removed value is shown by red letters.
(During Rinse of Dialyzer process)
14-24
14.3.8. Confirmation of Dialysate Concentration
1. Prepare a syringe to sample dialysate and a measuring instrument that can accurately
measure the conductivity within the range of 10.0-18.0 (mS/cm).
2. Confirm that the title displayed is RINSE OF DIALYZER.
3. Sample dialysate by using the syringe from the sample port.

4. Confirm that the conductivity is within the normal range.
DANGER
Before connecting to the patient, collect a sample of dialysis concentration to ensure that the
conductivity is appropriate. If the actual and displayed conductivities differ, stop any operation
and check the system.
14-25
14.4. Connection to the Patient
CAUTION
Take extreme caution when connecting the bloodline to a patient or disconnecting from a patient
because accidents such as blood loss or air entering may happen.
14.4.1.Procedure of connection to the patient
NOTE)
Machine forcibly move to END OF DIALYZER RINSE process when detect blood during RINSE
OF DIALYZER process.
1. The operation of the blood pump stops when the CONNECT button is pressed, and
stops dialyzer rinse. Connect an arterial line to the patient and exchange the saline
solution in the bloodline with blood by operating the blood pump 1 pressing the pump1
ON/OFF switch.
2. Exchange the saline with blood to the needle.
In case of the “BP Stop By Blood At Connect” is set to ON in Software Option setting,
stop the blood pump when blood sensor detect blood.
After stop the Blood Pump, be able to use Blood Pump override. Blood pump operate
during keep pressing blood pump 1 ON/OFF switch. Then the maximum Blood pump
rate is 100 mL/min.
On the other hands, the setting is off, blood pump does not stop automatically.
Before blood reached to the needle, need to stop the blood pump by pressing the
pump 1 ON/OFF witch.
3. Connect a venous line to the patient.
14-26
14.5. Confirmation of TREATMENT DATA
1. Confirm that the value at “UF REMOVED” is 0.00 L in the screen.

2. Display the ten-key pad by pressing the numeral portion of “UF GOAL”, and set the
target UF volume.
3. Display the ten-key pad by pressing the numeral portion of “ TIME LEFT”, and set the
UF (ultrafiltration) time.
Ultrafiltration rate (UF RATE) is automatically calculated and displayed.
It is also possible to input the UF RATE after setting the target UF volume (UF GOAL).
In this case, the ultrafiltration time is automatically calculated and displayed.
DANGER
Wrong UF GOAL settings and UF RATE can put the patient into shock. Follow physician’s
instructions for settings for proper operation.
DANGER
Back filtration may occur with high flux dialyzer with low or zero UF rates due to pressure
gradients.
WARNING
An error may occur in the UF GOAL volume when dialysate pressure fluctuates, including during
the single needle operation.
14-27
NOTE
“Treatment time” would be extended due to the periodical Leak check during treatment mode.
During this check, count down of the TIME LEFT would be stopped.
Ex: In case of “Interval time=10min” setting (default value) and operate 4 hours treatment mode,
24 times of Leak checks are performed during 4 hours treatment. One time check takes around
10 sec. It means that the treatment time will be extended 4 min. totally.
4. Confirm that the current setting is appropriate by pressing the TREATMENT DATA
button.
5. Reconfirm that each setting is appropriate in this screen. Blue values are changeable
in this screen. Display the ten-key pad by pressing an intended numeral, input a new
set value, and then press the EXIT button if the set value is correct. The screen
returns to the previous screen.
14-28
14.6. Setting Kt/V
Kt/V is the marker of that the wastes (such as urea) ware removed by the hemodialysis
treatment.
WARNING
The Kt/V screen attempted to predict the Kt/V of a treatment. This predicted Kt/V is not
measured but a calculated value, therefore the value can not be used for the adjustment of
treatment. The predicted Kt / V of the Kt/V screen and the actual Kt / V can differ from each
other. If the correct Kt/V value is necessary, use the measuring instrument and measure Kt/V
value.
1. Open the Kt/V screen in one of two ways.

・Menu → Nurse → Treatment → Kt/V
・The display of Kt/V in Treatment Data screen (Below diagram).
①
②
⑧
③
④
⑤
⑥
⑦
⑨ ⑩ ⑪
NOTE
The graph is not plotted and Current Kt/V remains 0.0 for 5 minutes after a treatment start.
Time during SEQ-UF is not included at the treatment time.
14-29
Patient Patient Information Nunber.
①
Information Setting range: 1 to 8
Sex of the patient.
② Sex
Setting range: Male or Female
Height of the patient.
③ Height
Setting range: 50 to 250 (cm) / 20 to 100 (in)
Weight of the patient
④ Weight
Setting range: 20 to 300 (Kg) / 40 to 660 (lb)
Age of the Patient
⑤ Age Setting range: 1 to 120
When sex is female, this item is not displayed.
Blood flow rate for Kt/V calculation.
⑥ Blood Rate During 5min from start of treatment, calculate from this rate.
After this time, calculate the Kt/V value from BP setting rate.
⑦ Time UF Time for Kt/V calculation.
Display of the Kt/V Graph area.
Green horizontal line :Target value
⑧ Graph area Blue line : Connecting “0” to “Current” value
Yellow line : Connecting “Current” to “Estimated” value
When touch this area, transferring to the Graph screen..
Target value of the Kt/V
⑨ Target
Setting range: 0.5 to 2.0
Display of the Current Kt/V value.
⑩ Current When this value is more than or equal to Target value, this
background color changes from Red to Green.
Display of the Estimated Kt/V value.
When this value is more than or equal to Target value, this
⑪ Estimated background color changes from Red to Green.
If this value is 2.0 or more, a display does not change from 2.0 and
the letter color changes to red.
2. Select the Patient Data and input the patient data.

The machine can store information about 8 Patient Data.
3. Input the target value of Kt/V in “Target” column.

Estimated Kt/V is calculated from Patient Information, UF Time and Blood rate.
NOTE
After starting the Treatment, cannot change these values.
NOTE
The graph is not plotted and Current Kt/V remains 0.0 for 5 minutes after a treatment start.
Time during SEQ-UF is not include ar the treatment time.
14-30
NOTE
The Unit of UF Goal, patient weight and length, and splitted UF volume of UF PROFILE is
changed by L, kg and lb button in the TREATMENT DATA screen.
14-31
14.7. Reminder Clock
NOTE
Reminder clock was added since software version 7.20.
The reminder clock screen was shown in most screen, and always available.
Press and hold Press
Set the number of chimes by UP / DOWN Set the times and press START button to
key. start this function.
If set it to Zero, the notice without chimes. E.g. 00:45:30 -> 4530
01:30:00 -> 13000
The setting intervals from 1 sec to 99:59:59.
When the setting time has reached, rings the chimes setting number of times (Initial setting: 5
times), brink the blue lamp.and show the Message “2104 The programmed remaining time has
been reached”.
If quit this, press CLR(Clear) and START button in that order.
NOTE
Reminder clock does not affected by the alarm actions and treatment end, etc.
14-32
14.8. Dialysis Process
1. Press and hold the DIALYSIS button.
When an electronic sound is heard, the dialysis operation begins.
It is possible to display various information such as the arterial pressure, the venous
pressure. To display such information, touch the vicinity of the intended item and
in the screen as shown in the figure below.
14-33
Display area can display the
pressure during the dialysis
operation. Information appears by
pressing the display area, and each
press switches the information as in
the following table.
Display
Arterial side blood pressure (mmHg)
2 ARTERIAL PRESSURE
(Pre-Pump side)
3 VENOUS PRESSURE Venous side blood pressure (mmHg)
4 DIALYSATE PRESSURE Dialysate pressure (mmHg)
Display area can display thirteen (13) kinds of information. Information is displayed
when the display area is pressed and the information in the following table is switched by
each pressing.
Display
2 CONDUCTIVITY Conductivity of dialysate (mS/cm)
3 TEMPERATURE Dialysate Temperature (°C)
4 DIA.PRESS Dialysate pressure (mmHg)
5 BLOOD LEAK Blood leak (ppm)
6 DIA.FLOW Dialysis flow rate (mL/min)
7 TBV Treated Blood Volume (mL)
8 Current Kt/V Current value of Kt/V
9 TREAT.TIME Treatment time
10 UF FIN TIME. UF (ultrafiltration) remaining time
11 TMP Transmembrane pressure (mmHg)
12 UFRC Kuf
13 V. PRESS Bloodline venous side pressure (mmHg)
14-34
CAUTION
The screen allows to display the information, such as various pressures, temperature,
conductivity, and TMP. Monitor those informations during dialysis treatment.
DANGER
The venous pressure sensor detects blood leakage when it leaks out of the bloodline.
However, this function is not sufficient to protect the patient completely. Check various dialysis
data displayed during treatment and monitor the patient condition carefully to ensure safe
dialysis.
DANGER
The venous pressure sensor should not be used as the reliable method to detect venous
puncture errors.
When the medicine etc. mixed into dialysis solution, the Blood Leak Detector could
detect the blood leak.
BLD OVERRIDE button is displayed into a button display area after a predetermined
number alarm. (Software Ver.6.00 or later and Set “NURSE” to “USE”)
Press the button, override the function of blood leak detector during setting time.
(The setting of the override of BLD is able to set by the technician.)
CAUTION
Before using this function, confirm that the cause of alarm is not blood leak.
2. UF (ultrafiltration) stops automatically when the UF volume reaches the target value.
At this time, the completion message appears in the alarm display frame, blinking the
indication lamp (yellow) and sounding the electronic alarm.
3. When the dialysis operation is completed, the dialysis end screen appears.
14-35
14.9. Completion of Dialysis
Dialysis treatment and ultrafiltration automatically complete when the UF volume has
reached its target. At this time, "TREATMENT COMPLETE" is displayed and sounding the
electronic alarm, notifying the operator of the treatment completion.
CAUTION
Following the completion of dialysis, Minimum UF is activated and ultra filtration continues at a
slower speed, avoiding backfiltration before the initiation of the RETRANS process. Do not
allow this status too long to avoid excessive ultra filtration.
14.10. SEQUENTIAL UF (ECUM) Operation

SEQUENTIAL UF (ECUM) operation is enabled in the dialysis process.
DANGER
This function differs from the HF treatment. Do not regard this function as the HF treatment.
1. Confirm that the current UF volume (UF REMOVED) displayed in the screen has not
reached the target UF volume (UF GOAL).
2. Open the dialysis mode screen by pressing the portion shown in the figure below.
14-36
3. Select the SEQUENTIAL UF operation by pressing the SEQ-UF button.
The SEQUENTIAL UF operation begins immediately after the selection.
4. Press the EXIT button.

As soon as the present UF volume has reached the target UF volume, the
SEQUENTIAL UF operation automatically completes with an alarm sound.
To interrupt the SEQUENTIAL UF operation halfway, open the dialysis mode screen
again and press the HD button. In this case, the process returns to the normal dialysis.
14-37
14.11. Dialysis End
14.11.1. Procedure of Dialysis End
1. Confirm that the alarm is
sounding, the indication
lamp (yellow) is blinking,
and the UF
(ultrafiltration) has
completed.
2. Press the MUTE switch
to stop the alarm sound.
3. Press the RETRANS
button.
The blood pump
operation stops.
14.12. RETRANS and OVERRIDE mode

1. Disconnect the patient connector of the arterial bloodline from the patient, and
connect it with the saline solution bag.
Start the blood pump by pressing the ON/OFF switch to substitute blood with the
saline solution.
2. When the whole blood in the bloodline is substituted, press the ON/OFF switch to stop
the blood pump.
If some bubbles come to the venous clamp unit in some cases, the air bubble sensor is
activated by the detection of air. The alarm message, "FIND AIR BUBBLE" appears in the
screen, the air bubble detection alarm sounds, and the blood pump stops.
This occurs because the air bubble sensor detects air when blood is being returned. Under
normal conditions, the air bubble sensor closes the venous clamp and the blood pump stops.
However, when blood is being returned, for a certain period, the air bubble sensor can ignore
the alarm and continue to operate the blood pump (In default settings, OVERRIDE is possible
for up to 6 blood pump rotations).
DANGER
When OVERRIDE is in operation, Air bubble sensor cannot give any alarm.
14-38
3. Press the MUTE switch to stop the alarm sound.
4. The message “OVERRIDE” appears when the ON/OFF switch of the blood pump is
pressed. The venous clamp is released and the blood pump operates while the switch
is held pressed.
5. When the blood is retransfused to the patient, release the ON/OFF switch to stop the
blood pump.
6. Disconnect the patient connector of the venous bloodline from the patient.
Reference: Procedure to release bloodline from the Blood Pump
1) Open the Blood Pump cover.

2) Release the Tubing Clamp A and detach the upstream of Pump segment (See Figure 7).
3) Rotate rotor to the direction of clockwise not to nip tube carefully (Figure 8-9).
4) Detach the Pump segment of bloodline, and then release the other side of Tubing Clamp
5) Close the Blood Pump cover.
Tubing Clamp A
Figure 7 Figure 8 Figure 9
14-39
14.13. Disconnection of the Dialyzer
DANGER
Remove the bloodline from the patient before discarding the remaining fluid in the dialyzer, since
it can cause serious harm to the patient.
1. Remove the blue coupler from the dialyzer and return it to the blue coupler holder
according to the instruction "Disconnect BLUE-COUPLER and Return to Coupler
Receiver." displayed in the screen.
2. The removal operation of the dialysate remained in the dialyzer begins.

3. Remove the red coupler from the dialyzer and return it to the red coupler holder
according to the instruction "Disconnect RED-COUPLER and Return to Coupler
Receiver." displayed in the screen.
The screen returns to the RINSE STANDBY screen.
14-40
14.14. Ending Operation
1. Confirm that the blood pump has stopped.
2. Correctly return concentrate nozzles A and B.
3. Disconnect the bloodline from the arterial pressure and venous pressure connection
ports.
4. Open the venous clamp unit and take out the bloodline.
5. Remove each drip chamber from the holder.
6. Open the blood pump cover and remove the bloodline tube by manually turning the
rotor.
7. Abandon the dialyzer and the bloodline.
DANGER
Be sure to disinfect the machine after each dialysis.
CAUTION
Dispose the dialyzer, the bloodline, and the needle immediately after use in accordance with the
local regulation in your area.
14.15. Discarding the bloodline and dialyzer
DANGER
Used bloodlines and dialyzer can cause of infection. Discard them appropriately in accordance
with your community or facility rules.
14-41
14.16. Display of Last Treatment Data
NOTE
Display of Last Treatment Data was added since software version 7.20.
After Treatment End, the last Treatment data was displayed in Last Treatment Data Screen
until .next treatment start.
Press the “LAST DATA” button, shows the Last Treatment Data screen.
14-42
The most data was record at the treatment start, the
data that is shown in right figure were recorded when
return to Rinse Standby screen after treatment.
The Maximum of three data was shown in list area, and the date are highlighted in light gray in
the graph area.
When press the UP/DOWN key or dark gray area in graph, these data are shown together.
14-43
14.17. Turning OFF the Power Supply Breaker
1. Return to the Rinse standby screen.

If the machine works in Rinse, Disinfection, Preparation or Dialysis process, wait until
the process end or return to Rinse standby screen.
CAUTION
For machinery protection, ensure the rinse and disinfection of hydraulic after treatment.
2. Press the Power ON/OFF switch for 3 seconds or more to turn off the power.
Then, the lamp of the Power ON/OFF lamp is off.
3. Turn OFF the Power supply bleaker.
14-44
15 SINGLE NEEDLE OPERATION
DANGER
At single needle operation, keep monitoring the venous pressure (PG5) as the single needle
pressure (SN pressure). A correct dialysis operation is ensured only with the appropriate
upper/lower limit setting values. In setting the values, be sure to follow the instructions of a
doctor.
When the SN pressure reaches the upper limit, the blood pump stops and open the venous
clamp in bloodline. While the SN pressure is below the lower limit, the venous clamp is closed
and rotate the blood pump until SN pressure reaches the upper limit.
SN Pressure
Upper limit
Lower limit
ON ON ON ON
BP
OPEN OPEN OPEN

CLAMP
CAUTION
At the single needle operation, be sure to use the exclusive single needle.
CAUTION
The displayed blood pump flow rate is the instantaneous value when the set blood pump is
under rotation.
NOTE
For the recirculation rate in the blood flow, contact the manufacturer or the sales representative.
15-1
15.1. Selecting single needle (SN)
1. Press the HD DN/SP button (indicated by the arrow mark in the figure below) to confirm
the setting.
2. Confirm that the SN/SP button is in orange (see the figure below). Also confirm the other
settings on the display, and press EXIT to return to the previous screen. When the
setting is inappropriate, touch the number to change to display ten-key pad, and input the
appropriate values.
15-2
15.2. Setting SN parameters
Pressing MENU → NURSE → TREATMENT → SINGLENEEDLE to confirm the switching
pressure. The CHANGE LOWER POINT is the lower limit, and CHANGE UPPER POINT is the
upper limit.
When the setting is inappropriate, input the appropriate values. Press EXIT to return to the
previous screen.
Accessible
Display Description
MODE
MIN TECHNICIAN Lower limit setting accessible in the NURSE mode.
CHANGE
NURSE Lower limit setting at the single needle operation.
LOWER POINT
CHANGE
NURSE Upper limit setting at the single needle operation.
UPPER POINT
MAX TECHNICIAN Upper limit setting accessible in the NURSE mode.
NOTE
When the single needle operation is performed with the standard bloodline of default setting, the
blood suction volume per stroke is approximately 15 mL. This is the typical values, and varies
depending on the bloodline, patient condition, and machine setting.
15-3
15.3. Setting SN pressure alarm
When the SN operation is selected, the venous pressure sensor (PG5) is recognized as the SN
pressure sensor. Accordingly, the operation is given by the SN pressure alarm setting, not by the
PG5 pressure alarm setting.
CAUTION
In the SN operation, ensure the correct pressure alarm setting.
1. Select MENU → NURSE → PRESSURE ALARM → SN PRESS to display the

PRESSURE ALARM screen.
2. Confirm the setting of LOWER WIDTH and UPPER WIDTH, and change them if
inappropriate. Press EXIT to return to the previous screen.
15-4
Accessible
Display Description
MODE
MIN STROKE When the blood volume per stroke is under this setting
TECHNICIAN
VOLUME value, SN STROKE VALUE FAULT is alarmed.
When the SN pressure does not reach the upper/lower
MAX STROKE
TECHNICIAN limit within this setting time, SN STROKE FAULT is
TIME
alarmed.
MAX VOLUME When the blood volume per stroke is over this setting
TECHNICIAN
LIMIT value, SN MAX VOLUME FAULT is alarmed.
The pressure alarm setting range for the SN pressure
MIN TECHNICIAN sensor. Exceeding the range during power ON will alarm
the SN MINIMUM PRESSURE alarm.
The pressure alarm setting range for the SN pressure at
LOWER WIDTH NURSE dialysis operation. Exceeding the range during dialysis will
alarm the SN LOWER LIMIT alarm.
The pressure alarm setting range for the SN pressure at
UPPER WIDTH NURSE dialysis operation. Exceeding the range during dialysis will
alarm the SN UPPER LIMIT alarm.
The pressure alarm setting range for the SN pressure
MAX TECHNICIAN sensor. Exceeding the range during power ON will alarm
the SN MAXIMUM PRESSURE alarm.
15-5
15.4. Dialysis by SN operation
15.4.1. Dialysis operation
For basic operation, refer to Chapter14.
NOTE
In selecting SN, the screen displays SN Pressure bar graph instead of PG5 during the operation.
15.4.2. Screen in dialysis

In the SN operation, the screen displays the SN pressure instead of venous pressure.
Refer to the following figure and table.
4 3 5
1 2
No. Parameter Description
Indicates the SN lower limit. When the bar graph is under

SN
1 the position, the venous clamp is closed and rotates the
Lower Limit Icon
blood pump.
Indicates the SN upper limit. When the bar graph is over this
SN
2 position, the venous clamp is opened and stops the blood
Upper Limit Icon
pump.
Pressure Alarm Setting When the SN pressure exceeds the range during dialysis,
3
Range Display Bar the SN LOWER / UPPER LIMIT is alarmed.
When the SN pressure is under the threshold during
Lower Limit Alarm
4 machine power ON, the SN MINIMUM PRESSURE is
Threshold
alarmed.
When the SN pressure exceeds the threshold during
Upper Limit Alarm
5 machine power ON, the SN MAXIMUM PRESSURE is
Threshold
alarmed.
15-6
16 REFERENCE MATERIAL
16.1. Dialysate Flow Chart (TYPE 1)
Note) This flowchart is applicable to the models with serial No. 04A0208E or later.
16-1
Symbol Name Symbol Name
Pressure reducing valve for
PR1 V52 Disinfectant solenoid valve (OP)
supply water
V1 Water inlet solenoid valve V12 B / A2 2nd Central solenoid valve (OP)
HEX Heat exchanger V17 B / A2 1st Central solenoid valve (OP)
T6 Thermo sensor 6 V14 Intercept solenoid valve (OP)
TS1 Thermostat V18 A / A1 2nd Central solenoid valve (OP)
BT Buffer tank for water heating V19 A / A1 1st Central solenoid valve (OP)
H Heater FL7 Filter 7 (OP)
OL3 Orifice 3 BT3 Buffer tank
BT1 Buffer tank for deaeration FS1 Flow switch 1
P1 Deaeration pump CHa Measuring chamber A
AS1 Deaeration tank CHb Measuring chamber B

CHa solenoid valve for filling fresh
RV1 Relief valve 1 V21
dialysate solenoid valve
CHa solenoid valve for supplying fresh
V16 Water inlet solenoid valve V22
CHb solenoid valve for filling fresh
V11 Water inlet solenoid valve V23
CHb solenoid valve for supplying fresh
BT2 Buffer tank V24
Temperature sensor for diluted CHa solenoid valve for discharging
T2 V25
B concentrate drain solenoid valve
Conductivity sensor for diluted B CHa solenoid valve for filling drain
CD2 V26
concentrate solenoid valve
Temperature sensor for diluted CHb solenoid valve for discharging
T4 V27
B concentrate drain solenoid valve
Conductivity sensor for diluted B CHb solenoid valve for filling drain
CD4 V28
concentrate solenoid valve
P4 B concentrate pump FS2 Flow switch 2
FL3 Filter 3 T3 Dialysate temperature sensor
P5 A concentrate pump CD3 Dialysate conductivity sensor
FL4 Filter 4 T1 Dialysate temperature sensor
V13 B drain solenoid valve CD1 Dialysate conductivity sensor
V15 A drain solenoid valve V31 Bypass solenoid valve
V51 Disinfectant solenoid valve CF Endotoxin retentive filter (OP)
FL6 Filter 6 V32 Dialysate supply solenoid valve
16-2
Symbol Name Symbol Name
C1 Check valve FL2 Filter 2 for cartridge (OP)
SL Sample port V35 Cartridge priming solenoid valve(OP)
V33 Dialysate return solenoid valve V34 Cartridge drainage solenoid valve (OP)
AS2 Air separator tank PG4a Arterial pressure sensor 1
RV2 Relief valve 2 TPFL1a Filter 1a
FW Float switch V71 Level adjusting solenoid valve (OP)
V41 Degassing solenoid valve BP1 Blood pump

Pressure exhaust solenoid
V42 HP Syringe pump
valve
BLD Blood leak detector TPFL1b Filter1 (OP)
P3 UF pump PG4b Dialyzer inlet pressure sensor (OP)
PG3 Dialysate pressure sensor V73 Level adjusting solenoid valve (OP)
P2 Dialysate pump TPFL4 Filter 4
V2 Re-circulation solenoid valve P6 Blood chamber level adjustment pump
V4 Drainage solenoid valve V72 Surface adjustment valve
V3 Three port solenoid valve (OP) TPFL2 Filter 2
C13 Check valve (OP) PG5 Venous pressure sensor
TPFL8 Filter 8 (OP) ABD Air bubble detector
FL1 Filter 1 for cartridge (OP) BD Blood detector
SW1 Holder switch 1 (OP) CL2 Venous clamp
SW2 Holder switch 2 (OP)
NOTE : (OP)・・・・Options
16-3
16.2. Color Lamp - State Diagram
Machine indicates the conditions by 4 colors lamp, red, yellow, green, and blue. Present
condition of the machine is shown by the ON/OFF combination of these four colors.
State of lamp:
Red
Yellow
Green
Blue
Lamp is ON Lamp is blink
State of color lamp

Process Remarks
(Normal state) (At alarm)
Usual condition when power

ON/OFF switch is turned ON
Rinse standby
ON: No color
Blink: No color
Green lamp turns ON when

rinse process begins.
Rinse process
Blink: No color
ON: Green
Yellow and green lamps

Dialysis
blink during startup test
preparation
process
(Include
Blink: Yellow, Green
startup test)
ON: No color.
16-4
State of color lamp
Process Remarks
Dialysis
Green lamp blinks when
preparation
mixture of dialysate begins.
End

Connection Blink: Green
process ON: No color
Green lamp turns ON in the

dialysis process.
Dialysis
process
Blink:
ON: Green
Blue lamp turns ON in

Dialysis
Sequential UF.
process
Sequential
UF operation Blink: No color
ON: Green
Green blinks when flow to

dialyser is bypassed by
Dialysis abnorma concentration, etc.
process
bypass
Blink: Green
ON: No color
Yellow lamp blinks when

reached to the set UF
volume. Yellow lamp
Dialysis
changes to ON when the
process
chime of the dialysis
At UF
completion is muted with
completion
MUTE button.
Blink: Yellow
ON: Green
16-5
State of color lamp
Process Remarks
Green lamp blinks during the

collection process and
Collection patient is disconnected.
process
Blink: Green
ON: No color
NOTE) The red lamp blinks when machine detects the alarm condition, and the lamp changes to
ON when the alarm sound is muted by pressed MUTE button. However, the alarm
resume and the red lamp blink if alarm condition was not dissolved within 2 minutes in
the dialysis preparation process and the dialysis process.
16.3. State of Backup Battery Operation
Added the backup battery indicator during battery operation from software version 7.21.
When machine is operated by backup battery, the battery state and elapsed time is displayed in
bottom right.
The indicator is shown in three levels (signals) in accordance with the remaining battery level.
NOTE
The battery capacity vary according to the frequency in use, environment and so on.
The time of each span is not same, because the state is shown by remaining battery.
From battery performance charactaristics, the time during red signal is very short compared to
time of green or yellow signals.
16-6
16.4. Alarm Output at the Start-up process
Note) This alarmd are applicable to the Software version Ver.07.00 or later.
For some reason, output the alarm on the wake-up screen.
The three alarms are displayed in this screen.
・Combinations of PCB are different” , “CPUERR

・Combinations of Software are different”, “CPUERR
・Touch Panel Error !! (Code:08)
In this case, screen does not change to “Rinse Standby Monitor”. Please turn off and confirm the
containts of maintenance, etc. by maintenance persons.
16-7
Accompanying Documents for EMC
１． Technical Information
Table 201
Guidance and Manufacturer’s declaration – electromagnetic emissions

The single patient dialysis machine DIAMAX is intended for use in the electromagnetic environment
specified below. The customer or the user of the single patient dialysis machine DIAMAX should assure
that it is used in such an environment.
Emissions test Compliance Electromagnetic environment － guidance
The single patient dialysis machine DIAMAX uses RF energy
RF emissions only for its internal function. Therefore, its RF emissions
Group 1 are very low and are not likely to cause any interference
CISPR 11 in nearby electronic equipment.
The single patient dialysis machine DIAMAX is suitable for
RF emissions use in all establishments other than domestic and those
Class A directly connected to the public low-voltage power supply
CISPR 11 network that supplies buildings used for domestic purpose.
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations
/flicker emissions
Complies
IEC 61000-3-3
Table 202
Guidance and manufacturer’s declaration – electromagnetic immunity
specified below. The customer or user of the single patient dialysis machine DIAMAX should assure
Electromagnetic environment
Immunity test IEC 60601 test level Compliance level
– guidance
±6 KV contact ± 6 KV Floors should be wood, concrete
Electromagnetic
or ceramic tile. If floors are
discharge(ESD)
±8 KV air ± 8 KV covered with synthetic material,
the relative humidity should be
IEC 61000-4-2
at least 30%.
±2 KV for power ± 2 KV Mains power quality should be that
Electrical fast
supply lines of a typical commercial or
transient /burst
hospital environment.
±1 KV for ± 1 KV
IEC 61000-4-4
input/output lines
±1 KV differential mode ±1 KV Mains power quality should be that
Surge of a typical commercial or
±2 KV common mode ±2 KV hospital environment.
IEC 61000-4-5
＜5％ UT ＜5％ UT Mains power quality should be that

(＞95％ dip in UT) (＞95％ dip in UT) of a typical commercial or
for 0.5 cycle for 0.5 cycle hospital environment. If the user
the single patient dialysis
Voltage dips, short 40％ UT 40％ UT machine DIAMAX requires continued
interruptions and (60％ dip in UT) (60％ dip in UT) operation during power mains
voltage variations for 5 cycles for 5 cycles interruptions, it is recommended
on power supply that the single patient dialysis
input lines 70％ UT 70％ UT machine DIAMAX be powered from an
(30％ dip in UT） (30％ dip in UT） uninterruptible power supply or
IEC 61000-4-11 for 25 cycles for 25 cycles battery.
<5％ UT <5％ UT
(＞95％ dip in UT) (＞95％ dip in UT)
for 5 cycles for 5 cycles
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
(50/60Hz) should be at levels
magnetic field characteristic of a typical
location in a typical commercial
IEC 61000-4-8 or hospital environment.
NOTE UT is the AC mains voltage prior to application of the test level.
Table 204
Guidance and manufacturer’s declaration – electromagnetic immunity
specified below. The customer or user of the single patient dialysis machine DIAMAX should assure
Compliance
Immunity test IEC 60601 test level Electromagnetic environment – guidance
level
Portable and mobile RF communications
equipment should be used no closer to any
part of the single patient dialysis machine
DIAMAX, including cables, that the
recommended separation distance calculated
from the equation applicable to the
frequency of the transmitter.
Recommended separation distance

Conducted RF 3 Vrms ｄ＝(3.5/V)・√P
IEC 61000-4-6 150KHz to 80MHz 3 Vrms
Radiated RF 3 V/m 3 V/m ｄ＝(3.5/E)・√P 80MHz to 800MHz
IEC 61000-4-3 80MHz to 2.5GHz ｄ＝(7/E)・√P 800MHz to 2.5GHz
where P is the maximum output power rating

of the transmitter in watts(W) according
to the transmitter manufacturer and ｄ is
the recommended separation distance in
meters(m).
Fields strength from fixed RF transmitters,

as determined by an electromagnetic site
survey, a should be less than the
compliance level in each frequency range.
b
Interference may occur in the vicinity of

equipment marked with the following symbol:
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
a
Field strength from fixed transmitters, such as base situations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot
be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If the measured field strength
in the location in which the single patient dialysis machine DIAMAX is used exceeds the applicable
RF compliance level above, the single patient dialysis machine DIAMAX should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the single patient dialysis machine DIAMAX.
ｂ
Over the frequency range 150KHz to 80MHz, field strength should be less than 3 V/m.
Table 206
Recommended separation distance between portable and mobile RF communications
equipment and the single patient dialysis machine DIAMAX.
The single patient dialysis machine DIAMAX is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the single patient
dialysis machine DIAMAX can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment(transmitters) and the single patient
dialysis machine DIAMAX as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter

Rated maximum output power ｍ
of transmitter
Ｗ
150KHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
ｄ＝(3.5/V)・√P ｄ＝(3.5/E)・√P ｄ＝(7/E)・√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters(m) can be estimated using the equation applicable to the frequency of the transmitter,
where P is the maximum output power rating of the transmitter in watts(W) according to the transmitter
manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

MX1010-1704E4 - Instructions Manual

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INSTRUCTION MANUAL

SINGLE PATIENT DIALYSIS MACHINE

Nipro Europe N.V.

1 INTENDED FOR USE AND CONTRAINDICATION ............................................................. 1-1

2 RISKS AND BENEFITS OF MEDICAL SOLUTIONS ...........................................................2-1

5 MEANINGS OF SYMBOLS AND DISPLAYS .......................................................................5-1

8 MACHINE OF CONFIGURATION .........................................................................................8-1

9 CONFIGRATION OF OPERATING SECTION ......................................................................9-1

10 ACTIVATION OF ALARM AND ITS RESETTING METHOD..............................................10-1

11 DAILY MAINTENANCE .......................................................................................................11-1

13 RINSING AND DISINFECTING THE SYSTEM ...................................................................13-1

14 USING OF THE MACHINE .................................................................................................14-1

15 SINGLE NEEDLE OPERATION ..........................................................................................15-1

16 REFERENCE MATERIAL ....................................................................................................16-1

3.1. Equipment Classification and Handling precautions

3.2. Precaution for Fluid Penetration

3.3. Precaution for Flammable Atmospheres

3.4. Safety Precautions

Indicates an imminent hazardous situation, which, if the machine is misused, will

Indicates a potentially hazardous situation, which, if the machine is misused, may

2. Note and its indication

Before using the machine, be sure to read this manual.

Should follow about disinfectant procedure written in this manual.

Responsible organization should be responsible for hygienic quality of any delivery

3.6. Precaution for Software

Documents / Version Software Version

Caution, Consult documents

Ingress protection marking:

Degree of protection against electric shock: Type B

Degree of protection against electric shock: Type BF

Read usage instructions

O OFF (Main power)

Power ON/OFF switch

ON/OFF (Main power) indicator

BLOOD PUMP switch

6.1. Power Supply

Power supply: AC230V ± 10%, 50/60 Hz

Power consumption: 2.2 KVA MAX (Heater: 230V 750VA*2)

6.2. Water Supply Conditions, Drainage Conditions

6.2.1. Water supply conditions

6.2.2. Drainage conditions

6.2.3. Environment of Usage

6.3. Surrounding Space

6.4.1. Unpacking Carton and Confirmation of accessories

Instruction Manual Color Lamp

Handle for Pole

6.4.3. Assembling disinfectant nozzle holder/disinfectant tray

1. Unscrew the 8 screws [(A) circled in

2. Through the holes [(B) circled in the

4. Remove the 4 truss head screws [(E)

5. Using the Phillips-head

6. Follow the step 1 procedure in

8. When the disinfectant nozzle is not

1. Insert the hanger to the fixed pole as the figure above.

2. Remove the backside panel by

3. There is an unconnected connector

6.5. Releasing Hinge at Operation Panel

Some models of operation panel are secured

Remove tape from the front edge.

If the models that the operation panel does

Membrane sheet has covered by protective thin film.

Drainage 60cm or less

6.8. Water Supply