Nipro Ncu-18 User Manual

Single patient dialysis machine
NCU-18
Instruction Manual
! CAUTION
Read this instruction manual carefully before use.
Improper handling can result in an accident or malfunction.
Use the unit in accordance with this manual.
Keep this manual in an appropriate place to avoid misplacement.
Original Instructions
Table of Contents
Preface ················································································································ Preface-1
Brief description ································································································· Preface-1
Important notices································································································ Preface-1
Service live ········································································································· Preface-1
Intended use of this machine ··············································································· Preface-2
Intended operators of this machine ······································································ Preface-2
Contra-indications ································································································ Preface-2
RISKS and BENEFITS of hemodialysis ·······························································Preface-3
Responsibilities ···································································································· Preface-3
Daily inspection by operator ··············································································· Preface-3
Service and maintenance by technician ····························································· Preface-3
Safety··················································································································· Preface-4
Equipment classification and handling precautions ············································ Preface-4
Precaution for fluid penetration ·········································································· Preface-4
Precaution for flammable atmospheres······························································ Preface-4
Safety Precautions ······························································································· Safety-1
Initial start up ·······································································································Safety-1
Warning symbols ································································································· Safety-1
Precautions ·········································································································· Safety-6
Emergency Stop ·································································································· Safety-7
Emergency stop using the I/O power key··························································· Safety-7
Emergency stop using the power breaker ·························································· Safety-7
Transporting the Unit and Prohibited Actions ······················································· Safety-8
Disposals ············································································································· Safety-9
Disposal of the unit····························································································· Safety-9
Disposal of the Lead Acid battery for power failure backup ······························· Safety-9
Handling precautions ························································································ Safety-9
Upon disposing the product ·············································································· Safety-9
Symbols ···············································································································Safety-10
Software version ·································································································· Safety-11
Precautions to be taken before handling ······························································ Safety-12
Service technician ······························································································ Safety-12
Well-planned maintenance ················································································· Safety-12
Clothes ···············································································································Safety-12
Handling the equipment ····················································································· Safety-12
Replacement parts ····························································································· Safety-12
Liability for readjustment and repair ··································································· Safety-12
Daily inspection by operator ················································································· Safety-13
Monthly inspection ····························································································· Safety-13
Maintenance and inspection by service technician ············································ Safety-13
Maintenance by service technician ···································································· Safety-14
Inspection after long-term storage······································································ Safety-14
Table of Contents-1
Maintenance and inspection instructions ····························································· Safety-15
Instructions on the maintenance and inspection log··········································· Safety-15
Maintenance and Inspection Log ········································································· Safety-16
Maintenance and Inspection Manual ··································································· Safety-17
1. Unit configuration ························································································ 1-1
1.1. Overall views································································································· 1-1

1.2. Operation panel ···························································································· 1-5
1.3. Blood circuit components ·············································································· 1-7
2. Message display monitor ············································································2-1
2.1. At machine start-up ···················································································· 2-1

2.2. Treatment screen ······················································································· 2-2
2.3. Examples for data entry (Treatment data) ·················································· 2-4
2.4. Heparin screen ··························································································· 2-6
2.5. Level adjustment screen ············································································2-7
2.6. Screen saver (Silent - screen) ····································································2-8
2.7. Priming screen ··························································································· 2-9
2.8. Reinfusion screen······················································································· 2-10
2.9. Cleaning standby screen ············································································ 2-11
2.10. Cleaning execution screen for single step (Rinse) ····································· 2-12
2.11. Cleaning execution screen for program (Program 1)·································· 2-13
3. Preparation ··································································································· 3-1
3.1. Turning on the NCU-18 ·············································································· 3-1

3.2. Concentrate supply ···················································································· 3-1
3.3. Preparation ·································································································3-3
3.4. Extracorporeal blood circuit with saline bag ··············································· 3-4
3.5. Extracorporeal blood circuit with online solution (with SPR option) ············ 3-7
3.6. Circulation process ····················································································· 3-9
3.7. Dialyzer filling ····························································································· 3-9
3.8. Adjusting the drip chamber liquid level ······················································· 3-10
3.9. Setting treatment data ················································································ 3-11
4. Treatment ·····································································································4-1
4.1. Start of treatment ······················································································· 4-1

4.2. Single-Needle Click-Clack ·········································································· 4-2
4.3. To Start Single-Needle Click-Clack ···························································· 4-2
4.4. SQUF Operation························································································· 4-6
Table of Contents-2
5. Reinfusion ····································································································5-1
5.1. Reinfusion ··································································································5-1

5.2. Emptying the dialyzer ················································································· 5-4
5.3. Emptying the B-cartridge (Option) ······························································ 5-4
5.4. Completion of treatment mode ··································································· 5-4
6. Cleaning operation ······················································································ 6-1
6.1. Setting of cleaning pattern·········································································· 6-2

6.2. Check before the cleaning operation ··························································6-3
6.3. Check during cleaning operation ································································6-4
6.4. Cleaning operation procedures ·································································· 6-5
6.5. Check after cleaning operation ···································································6-8
6.6. Clean up and disinfection ···········································································6-9
7. Light indicator ······························································································ 7-1
7.1. Light indicator specifications 1 ··································································· 7-1

7.2. Light indicator specifications 2 ··································································· 7-2
7.3. Description of terms ··················································································· 7-3
7.4. Escalation alarm system ············································································ 7-4
8. Alarm operations and recovery ·································································· 8-1
8.1. Description of alarms·················································································· 8-1

8.2. List of most common alarms ······································································ 8-6
8.3. Screen Failures ·························································································· 8-9
9. Power failure backup··················································································· 9-1
9.1. Power failure backup ·················································································· 9-1
10. Other functions ···························································································· 10-1
10.1. UF menu ···································································································· 10-1

10.2. Dialysate menu··························································································· 10-2
10.3. Subs. menu ································································································10-3
10.4. SN menu ＜Click clack＞ ··········································································10-4
10.5. System screen ··························································································· 10-5
10.6. Function screen ·························································································· 10-25
10.7. First aid button ··························································································· 10-30
10.8. Emergency saline infusion ·········································································10-31
10.9. Changing the CF ························································································ 10-32
10.10.Changing the Dialyzer or the Blood Tubing Set ········································· 10-33
10.11.Exchanging B-powder cartridge ·································································10-33
Table of Contents-3
11. Specification ································································································ 11-1
11.1. Unit Specification ······················································································· 11-1

11.2. Unit performance ························································································ 11-7
11.3. Safety devices ···························································································· 11-12
11.4 Functions of standard equipment ······························································· 11-14
11.5. Main display specifications ·········································································11-15
11.6. Applicable consumables············································································· 11-17
11.7. Option specification ···················································································· 11-19
12. ONLINE (OPTION) ····················································································· 12-1
12.1. ONLINE menu screen ················································································ 12-1

12.2. Specification ······························································································· 12-3
12.3. Auto-sub function ······················································································· 12-4
12.4. Substitution pump one-shot operation ························································12-4
13. Blood Pressure Monitor (Option) ·······························································13-1
13.1. Precautions for Usage of Blood Pressure Monitor (option) ························ 13-1
13.2 Preparation ·································································································13-1
13.3 Blood pressure monitor screen ·································································· 13-2
13.4 Attaching the cuff to a patient ····································································· 13-3
13.5 Measurement ····························································································· 13-4
13.6 BPM History screen···················································································· 13-4
13.7 Messages ··································································································· 13-5
13.8 Specifications of the BPM module ······························································ 13-8
13.9 Technical Information ················································································· 13-10
13.10.Maintenance ······························································································ 13-11
14. Card System (Option) ·················································································· 14-1
Glossary ··············································································································· Glossary-1

Appendix ·············································································································· Appendix-1
Dialysate circuit flowchart/List of Codes ··························································· Appendix-1
List of codes ····································································································· Appendix-2
Electrical Construction······················································································ Appendix-4
Process transition paths ··················································································· Appendix-5
Screen transition paths ····················································································· Appendix-6
Material(intended to come into contact with the water, dialysing fluid, dialysing fluid concentrate) ····· Appendix-7
Table of Contents-4
Preface
Thank you for purchasing NIPRO SINGLE PATIENT DIALYSIS MACHINE NCU-18.
Brief description
This is a single patient dialysis machine with a built-in dialysate preparation system and piston
pump ultrafiltration control system. Preparation is based on a feedback control method.
Any other device or equipment need not to be used in combination with this machine for dialysis
treatment. This machine controls and monitors dialysate circuit and extracorporeal blood circuit.
The extracorporeal blood circuit control panel is designed to allow easy settings and operations.
The blood can be heparinized either continuously or by one single bolus injection using the heparin
pump.
The NCU-18 can be used for either acetate dialysis and bicarbonate dialysis
The screen of the operation panel contains a clear 10.4 inch TFT color liquid crystal display with a
touch panel. It allows dialogue-assisted operation and easy management of emergency situation
during an alarm.
This machine reflects the state-of-art. This machine is classified in class IIb according to MDD and
is equipped with all necessary safety device required for the performance and patient safety. Refer
to chapter 11 for the applicable standards.
Important notices
This instruction manual describes proper and safe operation of the machine.
It is not intended for patient management.
Before using the machine, the responsible organization or person has to be instructed by the
manufacturer how to use the machine and be familiar with the contents of the operating
instructions
Read this instruction manual (and related instructions) carefully before use.
Understand the machine’s features and handling instructions and use it properly.
This instruction manual describes operation with standard functions.

For maintenance and inspection, see “Safety Precautions”.
Copyright of this instruction manual is protected and owned by the manufacturer.

Copying, duplicating, translating a part or a complete instruction manual without the
manufacturer’s permission is prohibited.
Service live
To guarantee the optimal lifetime of the NCU-18 it is recommended to respect the regular care, maintenance
and technical inspections of the machine.
Service life of this machine is 7 years.
Preface-1
Intended use of this machine
This machine can be used for patients with acute or chronic renal failure and when hemodialysis is
prescribed by an physician. This machine is intended to be used by trained operators for hospital,
health center or limited care. The system is a single patient hemodialysis system, which provides
dialysis fluid with a prescribed concentration and temperature to be used for hemodialysis
treatment.
The system is intended to be used with high and low permeability dializers.
This machine monitors during the dialysis treatment dialysate, blood circuit and machine functions.
The system tolerances (e.g. Fluid balance, air infusion) are designed to treat patients with 30 kg
body weight.
Depending on the model, the following types of therapies can be carried out:
Hemodialysis (HD)
Isolated ultrafiltration (ISO-UF)
Single needle dialysis (SN-CC)
Online Hemofiltration (O-HF in pre and post dilution)
Online Hemodialfiltration (O-HDF in pre and post dilution)
Single needle online Hemofiltration (SN-CC O-HF in pre and post dilution)
Single needle online Hemodialfiltration (SN-CC O-HDF in pre and post dilution)
All therapies can be carried out with different kind of UF, bicarbonate and sodium profiles.
Intended operators of this machine

This machine is intended to be operated by qualified doctors, nurses and clinical engineers with
skills specific to dialysis treatment such as introduction of blood to extracorporeal blood circuit, etc.
The instruction manual contains any information for the use of this machine.
The information must be carefully studied before attempting to operate the machine
Contra-indications
This machine is not designed, manufactured, or sold for use other than for hemodialysis for
patients with acute or chronic renal failure.
Attention should be paid to contra-indications valid for extracorporeal treatment in general.
Do not use high potassium percentage hemodialysis concentrates for HYPERKALEMIA.

Do not use potassium free hemodialysis concentrates for HYPOKALEMIA uncontrollable
coagulation anomalies.
A different method of extra-corporal treatment maybe indicated for hemodynamically unstable
patients.
Preface-2
RISKS and BENEFITS of hemodialysis
Hemodialysis treatment improves uremia, anemia, hypertension, etc. However, it can also cause
angialgia at puncture site, acceleration of hemorrhage, thrombosis and thrombemboli, infectious
diseases, disconnection, air embolism, hypothermia, hypotension during hemodialysis, nausea,
vomiting, disequilibrium syndrome, arteriosclerosis, cardiac failures, bone diseases, amyloidosis,
arrhythmia, anemia, etc.
Responsibilities
The organizer of hemodialysis is considered to work under the correct circumstances by means:
- Compliance with national and local safety regulations
- The operating instructions must be available at all times
- Correct and safe state and placement of the machine.
Daily inspection by operator
Check the following items before and after using the equipment on the same day.
Ensure normal operation of the equipment.
(1) Look for abnormalities, such as leakage around the equipment.
Check for loosening of clamps for the water supply opening and drainage opening
hoses.
(2) There is not residual chemical solution.
(3) Residual quantities of disinfection or acetic acid solution being enough.
(4) Consumption of disinfection or acetic acid solution being reasonable.
(5) The real concentration of dialysate being reasonable.
(6) There is no abnormal sound, a bad smell, over heat.
(7) Foreign substance such as disinfectant stain on the equipment exterior.
(8) Dialysate stain on the equipment. A dialysate stain can cause rust. Wipe it off
immediately.
(9) Abnormality when the start-up test is performed.
(10) If the equipment will be in operation overnight, ensure that the coupler is fit firmly on the
coupler holder.
(11) Confirm that the equipment detects the coupler switch signal.
(12) The syringe must be filled with the preset infusing volume.
Service and maintenance by technician
Service, maintenance, adjustments, repairs or modifications can only be performed by the

manufacturer or technicians authorized by the manufacturer.
The manual is subject to any change without notice. Any changes will be released as new editions
either supplements
Preface-3
Safety
This machine complies with the following standards
IEC 60601-1:1988+A1:1991+A2:1995
IEC 60601-1-2:2001+A1:2004
IEC 60601-2-16:1998
Equipment classification and handling precautions
This machine is classified as follows:

1 Type of protection from electric shock……Class I
2 Degree of protection from electric shock……Type B
Ensure the use of a protective earth connection.
The power plug is equipped with an earth connection.
Precaution for fluid penetration
Keep the machine out of water.

Protection against water infiltration……Drip-proof equipment IPX1
Precaution for flammable atmospheres
Do no use this machine in flammable atmospheres.
Preface-4
Safety Precautions
Proper operation and regular maintenance are essential for safe operation.
Thoroughly read and understand the safety precautions listed in this instruction manual before use.
Operation and safety precautions listed in this manual are specific intended for the use of this unit. If
this unit is used for other purposes, which are not listed in this instruction manual, the user will be
responsible for the consequential safety issues.
Initial start up
Before start up study the technical requirements in chapter 11 to ensure the machine works in the
correct conditions.
Initial start up can only be performed by a qualified technician with use of the procedures described in
the maintenance manual.
Warning symbols
(1) Degree of safety hazard, damage and displays (attention-attracting symbols and signaling terms)
Degree of safety hazard and damage that result from improper handling is classified into 3 levels.
Each level will be indicated by a specific attention-attracting symbol and signaling term.
! DANGER
This indicates an imminently hazardous situation which, if not avoided, will result in death or
serious injury.
! WARNING
It indicates a potentially hazardous which, if not avoided, could result in death or injury.
! CAUTION
This indicates a potentially hazardous, if not avoided, may result in moderate injury or
damage in property.
(2) Annotation and its display
NOTE
Annotation is displayed. Use this as a reference when handling the unit.
Because of our ceaseless research and improvement, details of the design of the unit described in this
manual may be slightly different from those of the unit you purchased. If you have any question about
the unit you purchased or contents of this instruction manual, please contact the nearest branch or
agency.
Safety Precautions-1
! DANGER
 Read this instruction manual before using the unit.
 When this machine is operated and maintained in a proper way, a safe and reliable treatment
is warranted.
 Before operating the unit, thoroughly read and understand this manual. Improper operation
can lead to injury or abnormal operation. This unit should be operated by professionals only.
 Learn the methods to immediately stop the treatment.
 To avoid serious problems, know how to quickly stop the operation.
 Do not allow non-professionals to operate the unit without having proper instructions.
 Know how to respond when the unit stops for any reason.
 Check the status of the unit and act in accordance with this manual.
 During the maintenance, special caution should be exercised for the electronic boards, electric
wiring, and terminals.
 Do not touch non-isolated electric wiring and terminals.
 Do not touch the electronic boards with a wet hand.
 Before touching the terminal block, disconnect the power plug from the power supply.
 During the connection/disconnection of a patient, special attention should be taken to avoid the
following risks that can harm the patient.
 Avoid air entrance into the patient.
 Do prime the blood circuit before connecting the patient.
 Do not connect the patient blood circuit during rinsing/disinfection.
 Prevent the contact of harmful viruses and chemicals with the patient.
 Inappropriate connection of the blood circuit is dangerous for the patient. A bad connection can
cause extracorporeal leakages. Improper pressure can result in rupture of the circuit. Ensure
that the blood circuit is connected properly at all times.
 Before connecting the patient, ensure that the alarm of the unit is not interrupted. Treatment
without using the alarm functions can cause great risks for the patient.
 Mixing of chlorine and decalcification solutions generates chlorine gases. Inhalation of these
toxic gases is very dangerous. Ventilate the room, and be careful not to inhale the generated
gases.
! WARNING
 Do not use the machine when a defibrillator is used on a patient (disconnect patient from unit) .
It`s not allowed by classification, because maybe result of medical intervention is not
given/reduced or the machine could be damaged. If the machine was connected when
defibrillator was discharged, check all machine functions and perform electrical check.
 Electronic equipment producing radio waves should not be used in the same room or building as
where this unit is used refer to chapter 11: Specification.
 Accessory equipment connected to the analog or digital interfaces must be certified according to
the latest IEC standards related to the purpose of the machine. Anyone who connects additional
equipment is responsible for ensuring that the system is conform the latest standards of IEC.
 Avoid the use of electronic equipment that produces radio waves including cellular phones,
transceivers, and radio-controlled toys. Use of this equipment inside of a hospital building can
lead to malfunction of the machine. (refer also to chapter 11, specifications)
 To prevent a possible accident, inform and instruct people not to carry or use radio-wave
producing equipment in the hospital building.
 The operator has to verify all the entered parameters in the system are correct. Any deviation
between the desired parameters and the displayed parameters must be corrected before using
the machine.
 Venous pressure
 Monitoring of the venous Pressure cannot always detect the disconnection of a venous needle
from its access site, which may result in extracorporeal blood loss to the environment. When
a venous needle disconnects from its access, pressure at the venous monitoring side may
only decrease by the pressure maintained within the patient’s access site. This pressure
drop may be less than the width of the machine’s venous pressure alarm window: in this
particular case the disconnection of a venous needle from its access site is not detectable by
the machine, even if pressure alarms and alarm windows are properly set.
 To reduce the risk of needles disconnection:
 Ensure that venous needle and line are firmly secured to the access site area according to
your clinic’s protocol.
 Ensure that the patient access is visible at all times during the dialysis treatment.
 Inspect frequently the patient’s access.
 Adjust properly the venous pressure alarm window: The venous pressure alarm lower limit
should be set as closely as practical to the actual patient’s venous pressure value without
generating excessive nuisance alarms
 Do not change the setting values during treatment if there is no emergency.
 Before selecting a function, ensure to understand the function thoroughly.
 Provide a drain opening in the floor.
 The power cable should not touch the floor to prevent from electric shocks due to a technical
failure and liquid leakages.
 Provide a drain opening near to the unit.
 Refer to the “Safety Precautions-13” before servicing the machine.
 Maintenance should only be carried out after thoroughly reading and understanding the
“Safety Precautions-13”.
 Maintenance should be performed in accordance with the directions.
 Look for professional help for repair and maintenance actions not listed in the “Safety
Precautions-13”.
 Do not choose unnecessarily functions during the treatment.
 Do not tilt the unit more than 5 degrees. It can overturn.
 Equipment, not permitted to be used together with this machine, may not be connected. The
total electric leakage current from the unit and other equipment together can exceed the
maximum allowable value.
 The operation and maintenance not specified by the manufacturer and the application of
unspecified accessories may cause death or injury of the patient. The manufacturer is not
responsible for the patient safety when the unit is operated, maintained, or calibrated by
methods not specified by the manufacturer. Trained and authorized personnel must operate the
unit in accordance with the methods established by the manufacturer.
! CAUTION
 Wear tools for protection when handling chemicals.
 Wear protection glasses and rubber gloves when handling chemicals.
 Characteristics of all chemicals being used should be realized to be able to treat appropriately
when a trouble occurs.
 Do not mix sodium hypochlorite with acetic acid, citric acid or peracetic acid
 If mixed, it may produce chlorine gas harmful to human body
 Inhalation of the generated chlorine gas will cause serious danger to the human body
 Before installing the unit, thoroughly read and understand the installation section of this manual.
 Only trained professionals may install the unit.
 Install the unit in accordance with the installation instructions.
 The connection of optional parts and the connection with an external unit should be performed
after reading and thoroughly understanding the corresponding manuals.
 Only trained professionals are allowed to do the connections.
 Check the dialysate parameters with external testing equipment before starting any treatment.
 Verify the actual dialysate concentration by an osmometer, conductivity meter, flame
photometer, etc.
 Check if the displayed concentration level is accurate.
 Verify, at the end of the cleaning, that there is no residual chemical or acid present.
 Verify, at the end of the disinfection the presence of chemicals (sodium hypochlorite, citric
acid, peracetic acid, or other chemicals) using a test paper or reagent.
 Do not use any force on the display monitor and touch panel.
 Avoid using force on the display monitor during surface cleaning.
 Do not use hard or sharp objects to operate the touch panel. The touch panel can be
damaged with operating malfunctions as a result.
 Ensure that setting values are not abnormal during treatment.
 Clean (disinfect and rinse) the unit thoroughly before use.
 Disinfection and rinse are necessary when the machine has been out of use for a long term.
 Disinfection and rinse are necessary when the machine has been out of use for a long term to
flush the waste water.
 Chemical or heat disinfection is needed after each manipulation on the hydraulic circuit (repair,
maintenance, …)
 Keep the machine always clean.
 Use aseptic technique for all blood-side connections
 Wipe off blood, dialysate, cleaning solutions carefully.
 Clean (disinfect and rinse) regularly.
 Note that some cleaning solutions such as Irgasan ruin the surface of the BP cover, etc.
 Some button operation cannot be accepted on some screens or during some processes.
 Use only dialysate concentrate containers with an appropriate label mentioning the composition
of the concentrate. Respect the color code during the connection of the concentrates (red for A
concentrate, blue for B concentrate).
 Use disposable products with the CE marking only.
 Handle used disposables carefully to prevent infecting yourselves and other persons. Used
disposables might be contaminated with viruses (hepatitis, aids, HIV, MRSA, …)
 To ensure the performance and safety of this unit, use water, dialysate concentrate, and fluid
replacement with appropriate quality.
 Technicians should use not contaminated tools and work under clean conditions
! CAUTION
 When using Central venous catheters the following instructions must be followed.
 Connect the dialysis system to a potential equalization conductor connection terminal of the
NCU-18 must be connected to the potential equalization of the electrical facility bus bar in order
to avoid micro-shocks.
 If additional ME equipment is used, ensure that all leakage currents are below the limit as for CF
applied parts.( below 10µA Max in normal conditions and below 50µA in single fault conditions.)
 This also applies for defibrillators. Which have no applied part type CF.
 Integrate all additional equipment to the potential equalization of the dialysis system
 This rule applies to all other electric ME equipment and non electric ME equipment (ex patient
bed) which are used in the reachable area of the patient.
 No other additional ME devices must be connected if these conditions are not fulfilled
Precautions
The following precautions should be noted when using this unit:
1. This unit should be operated by skilled personnel only.
2. Important notes concerning the installation of the machine:

(1) Keep the unit out of water.
(2) Only use the machine in normal conditions. Normal air pressure, temperature, humidity, wind,
sunlight. No air containing dust, salt, sulfur…
(3) Stability in terms of tilt, vibration, or impact (including those during delivery) should be taken
care of.
(4) Do not install the unit where chemicals are stored or gasses are generated.
(5) Take care about the frequency, voltage, and allowed current /power consumption of the power
source.
(6) Connect the earth protection properly.
3. Important notes concerning the use of the machine:

(1) Inspect touch panel sensitivity, polarity, dial settings, and meters. Verify that the machine
operates properly.
(2) Ensure that the earth protection is fully connected.
(3) Verify that all cable connections are intact.
(4) Exercise caution for concomitant use of equipment, since it can result in false diagnosis or
danger.
(5) Re-examine the external circuit that will be connected directly to the patient.
4. Important notes concerning the operation of the machine:

(1) Monitor the unit and patient for any abnormality at all times.
(2) When an abnormality is discovered in the unit or patient, act appropriately (e.g., stop the
operation after confirming the safety of the patient).
(3) Do not allow the patient to touch the unit.
5. Important notes concerning the end of the treatment:

(1) Turn the power off after returning operation buttons, dials, etc., to the original positions by the
indicated processes.
(2) When removing cables, do not apply inappropriate force such as pulling them by holding the
cables.
(3) Take care about the storage conditions:
1) Keep the unit out of water.
2) Store the unit in normal conditions. Normal air pressure, temperature, humidity, wind,
sunlight. No air containing dust, salt, sulfur…
3) Stability in terms of tilt, vibration, or impact (including those during delivery) should be
taken care of.
4) Do not store the unit where chemicals are stored or gasses are generated.
(4) Clean accessories, cables, electrodes, etc., and keep them in an organized way.
(5) Ensure to keep the unit clean to be ready for the next use.
6. When the unit fails, do not attempt to fix it. Note the failure description on the machine and look for
professional help.
7. Do not modify the unit.
8. Maintenance (See on and after "Safety Precautions-13".)

(1) Ensure to maintain the unit and its parts.
(2) Ensure that the machine operates normally and safely after a long period out of use.
9. Check other handling precautions listed on the instruction manual of the unit.
Emergency Stop
! WARNING
 Before stopping the system emergently, ensure that it will not interfere with the treatment. If
interference is a concern, stop the system after taking the necessary measures. Monitor the
patient at all times even if treatment is complete.
Emergency stop using the I/O power key
In all processes, if abnormalities are found in the unit and if continued use of the unit would
interfere with the treatment, press the I/O power key to turn off the system. (In such cases as
the liquid crystal display is suddenly turned off, or the touch panel button does not work.)
! WARNING
 All movements in the liquid crystal display, dialysate circuit, blood pump, and heparin pump stop.
! CAUTION
 After recovering the system using the I/O power key, if abnormalities are found in the unit
movements or it is impossible to continue using the unit, turn off the I/O power key and the
power breaker to stop the unit. Contact the nearest branch or agency.
NOTE
 To operate the I/O power key, press it for more than 3 sec.
Emergency stop using the power breaker
When the I/O power key is turned on but the power breaker is turned off, the dialysis function
stops and the power failure screen appears in the liquid crystal display. The power failure
backup operation takes place thereafter.
! CAUTION
 When the I/O power key is turned on and the power breaker is turned off, the liquid crystal
display, the touch panel, the blood pump, the bubble detector, the heparin pump, the venous
clamp and the arterial clamp operate in the power failure backup fashion. Turn off the Blood
pump I/O button and Heparin pump I/O button when necessary. Additionally, the alarm buzzer
goes off. Press the Mute key to mute.
Transporting the Unit and Prohibited Actions
! CAUTION
 Do not tilt the unit by more than 5 degrees. The unit can overturn.
 Do not place any object on the hanger when transporting.
(1) Release 2 locks at the right front and the left back of the caster.
(2) Transport the unit in the stand up position (vertical to the floor).
(3) Always push the back of the unit when transporting.
NOTE
 Do not transport on a rugged road.
 If a bump or a gap of 3 cm or more is present, spread a flat board or iron plate that can support
the weight of the unit on top of it before transporting.
 All 4 casters should be in contact with the road when transporting.
 Support the back of the unit, because the center of mass is toward the back.
 When transporting on a slope, be sure to face the front of the unit on the mountain side.
 Ensure that no objects are in the way while transporting.
 When transporting by a track, do not lay the unit on its side.
(4) Four or more people should attend when the unit needs to be lifted. (Three people should lift it
by holding the frame leg and the other person should support the upper of the unit.)
! CAUTION
 Do not hold by the cover. Be sure to hold by the frame.
Disposals
Disposal of the unit
The following are the precautions to be exercised when disposing the unit:
(a) Dispose resins (including the electric circuit board), rubbers, and electric wires as industrial wastes or in
accordance with the rules practiced in your community.
(b) To distinguish iron from stainless steel, gray color or be painted, it is iron; if not, it is stainless steel. The
surface of iron is painted or plated for anticorrosion.
Disposal of the Lead Acid battery for power failure backup
! DANGER
 The lead acid battery installed for power failure backup is specifically made for this unit.
Connecting this battery in other equipment can cause it to leak, release heat, or burst.
Handling precautions
The lead acid battery can leak, release heat, or burst if the following precautions are not
exercised. Be sure to take precautions.
-Do not throw it into fire or apply heat.
-Do not connect the positive and negative sides with metals, such as wire.
-Do not remove or scratch the external tube.
-Do not apply strong shock or throw it against an object.
-Do not disassemble or modify.
NOTE
 The lead acid battery is a consumable. It deteriorates in long-term use.
 The battery deteriorates even if the power failure backup operation is not performed.
! DANGER
 If fluid inside of the lead acid battery contacts eyes, it can result in blindness. Do not rub. Wash
the eyes immediately with water. Receive treatment from a physician without delay.
 If fluid inside of the lead acid battery contacts skin or clothes, it can damage the skin. Wash it off
with clean water without delay.
Upon disposing the product
Used lead acid battery is a valuable resource. Stick a insulation tape on the terminal or
connecting cord and bring it to the recycle shop that accepts lead acid batteries.
Symbols
Risk of tilting when inclined by more than 5゜.
Protective earth
General warning sign
Stand-by or preparatory state for a part of equipment
Type B applied part
Type BF applied part
This document is usable with the software version “1.02”. Check the list below for compliance with
the software version and this document before use. The software version can be checked on the
startup screen or System-Maker-3.Parameter setting screen.
Document ID Number
(as described on the rear cover) Software Version
CK1105-1311 1.02
Precautions to be taken before handling
! CAUTION
 Do not connect the equipment to a patient during maintenance.
Service technician
Only Service technicians who received a technical training of dialysis machines from Nipro, are
allowed to maintain the machine. Otherwise, a person who is being supervised by a trained
technician , is allowed to maintain the equipment.
Well-planned maintenance
Use of the equipment without planning maintenance, can decrease work efficiency and cause
injury, accident, and errors. It can also interfere with the original purpose, maintenance.
Schedule the time to maintain the equipment, and prepare necessary tools, parts, testing
equipment, and documents in advance.
Clothes
Try to minimize injury and accident by wearing appropriate clothes to work on the equipment.
Select clothes that do not attract a lot of electrostatics. Avoid exposing skin even if the
surrounding temperature is high.
Handling the equipment
Work in accordance with the instructions. Read the attached Instruction Manual carefully.
Transport and handle the equipment in accordance with the Manual.
Be sure to check the electric power line, water supply/drainage line, and other connection lines
before working on the equipment.
! CAUTION
* When returning electric equipment BOX which drew to the rear, please confirm that harness is
not sandwiched enough.
Replacement parts
Use the parts specified by the manufacturer.
Liability for readjustment and repair
A person who readjusted or repaired is liable for consequential events.
Daily inspection by operator
Check the following items before and after using the equipment on the same day.
Ensure normal operation of the equipment.
! CAUTION
* Please check daily inspection even if just after maintenance.
(1) There not being Abnormality, such as leakage around the equipment.
Check for connecting water supply tube and drainage tube, and conditions of tubes.
(bending, failure etc.)
Check for loosening of clamps for the water supply opening and drainage opening hoses.
(2) There not being leakage from the unit.
(3) Power supply cord being connected surely.
Please refer to installation procedure for the connection method.
(4) Alien substances such as the medicinal solution do not attach to unit cover.
(5) Dialysate stain on the equipment.
A dialysate stain can cause rust. Wipe it off immediately.
(6) Blood do not attach to the unit cover particularly PFI / arterial, and venous pressure
department.
When blood attaches, wipe it with disposable paper towel or cloth, after that, wipe with
water and then wipe it with sodium hypochlorite (1000ppm/0.1% dilution). And wipe the
part with a squeezed cloth which is moistened with water, and remove moisture with a
soft cloth.
! WARNING
 It might cause the mutual infection between patients by blood pollution.
(7) An alien substance do not be in the A/B concentrate solution line filter.
(8) Abnormality when the start-up test is performed.
(9) If the equipment will be in operation overnight, ensure that the coupler is fit firmly on the
coupler holder.
Monthly inspection
Clean the air filter of the fan.
Maintenance and inspection by service technician
Check the operating hours. Perform a periodical inspection every 5000 hours or every 6 months.
See “Maintenance and Inspection Log” for items to be inspected.
Maintenance by service technician
Check the operating hours. The service technician should maintain the hydraulic line and
electrical board every 5000 hours or every 6 months.
Inspection after long-term storage
Before starting dialysis treatment after more than 1 month of storage, a disinfection and a water
rinse of minimum 1 hour is required.
Also maintain and inspect the equipment in accordance with “Safety Precautions-15”
! CAUTION
* Do not connect the equipment to a patient during maintenance.
Maintenance and inspection instructions
The maintenance and inspection log shown in the next page is provided to record and keep the
results of maintenance and inspection. The log will help for the future maintenance and
management of the equipment. See “Safety Precautions-17” for the maintenance and
inspection methods. The person who maintains and inspects (a service technician or NIPRO
personnel ) must record the results in accordance with the instructions described in the
following. Make a copy of this form before logging.
Instructions on the maintenance and inspection log
(1) When to maintain and inspect

● Items with the “6□” symbol should be inspected every 6 months.
● Items with the “6□+□” symbol should be inspected every 12 months.
(2) Record the serial number of the equipment.
(3) Record the duration of the equipment operation.
(4) Record the date when the equipment was installed.
(5) Record the date when the equipment was inspected.
(6) Record the name of the person who inspected.
(7) Enter the results of inspection into the boxes next to the inspection items, using the
following symbols:
Symbol Results of inspection Recording priority
√ No abnormalities found
○ Required disassembly for inspection
X Exchanged 1
A Adjusted 2
T Tightened 3
C Cleaned 4
L Lubricated 5
● If two or more maintenance works are performed per item, refer to the above table and use
the symbol with higher priority.
Ex.) When an item is adjusted (A) and cleaned (C), enter “A” into the corresponding box.
● If inspection of an item requires disassembly, draw a circle around the symbol.
(8) Use the “Observation and Notes” column to write information, such as the part exchanged
during maintenance and inspection, when necessary.
! CAUTION
● Do not connect the equipment to a patient during maintenance.
● Dialysate and body fluid can cause infection. Never exchange parts before rinsing the hydraulic
lines.
NOTE
●Execute maintenance and inspection, make sure to keep the maintenance record, and store
the record properly.
Maintenance and Inspection Log
Maintenance and Inspection: 6-month inspection => 6□ 12-month inspection => 6□+□
Unit model: NCU-18 S/N of the unit: Duration of unit operation:
Date of unit installation: / / Date of inspection: / / Inspector: Signature
Results of inspection Observation

(Inspected: √, Disassembled: ○, Exchanged: X, Adjusted: A, Tightened: T, Cleaned: C, Lubricated: L) and Notes
1.Externals, connection tubes, and cables 8. Movements of monitoring and indication alarms
Conditions of connection tubes (bending, Temperature-related alarms
6
etc.)
6 (calibration of temperature indication)
Dialysate conductivity alarm
6 Connection to the drain pipe 6 (calibration of conductivity indication)
Presence of damage and connection of Venous pressure alarm
6
cables
6 (calibration of the venous pressure gauge)
Arterial / P-D pressure alarm
6 Conditions of the grounding conductor 6 (calibration of the art./P-D pressure gauge)
Damage/deformation that interfere with Dialysate pressure alarm
6
functions
6 (calibration of the dialysate pressure gauge)
6 Conditions of the light indicator 6 Blood leak alarm (movement of the blood leak detector)
Air bubble error alarm
6 (movement of the air bubble detector)
2.Water supply, concentrate feeder,
6 Blood detection alarm (movement of the blood detector)
and drainage areas
6 Conditions of tubes (bending, etc.) 6 Insufficient water supply
6 Movement / loosening of the solenoid valve 6 Alarm buzzer
6 Movement of the reducing valve 6 Blood leak alarm (calibration for blood-leak detection)
6 Movement of the degassing part
6 Movement of the degassing tank 9.Other items to inspect
6 Check of supplying flow 6 Bending, leakage, staining, etc of tubes
Abnormal sound/smell
6 Conditions of sheath type rinse ports 6 (STANDBY, DIALYSIS, RINSING)
6 Presence of air bubbles in the hydraulic line
3.Closed line area 6 Leakage from the hydraulic line
6 Movement / loosening of the solenoid valve 6 Filling flow rate
Movement and leakage in concentrates/UF
6
pumps
6 Filling-Up pressure
6 Movement during gas purge 6 Dialysate flow rate

Tightening the terminal block
4.Disinfectant/acid solution feeder areas
6 Movement / loosening of the solenoid valve 10.Substitution pump area
6 Residual disinfectant/acid solution 6 Loosening and abnormal sound in the rotating part
6 Conditions of the tube (bending, etc.) Consistency between displayed and actual flow volumes
5.Blood pump area 11.Powder Bicarbonate Assy (Option)

Loosening and abnormal sound in the
6
rotating part
6 Movement of the solenoid valve
Consistency between displayed and actual flow
volumes
6 Conditions of the tube (bending, etc.)
6 Damage/deformation that interfere with functions

6.Heparin pump area Stain, leakage, or blockage in filters
Movement of the heparin pump
6 Loosening of the heparin pump pulley 12.BPM area (Option)
Consistency between displayed and infused
Stain, leakage, or blockage in air filter
volumes
7.Electric tests
6 Short circuit breaker operation
Capacity of the battery for power failure
6 backup
Leakage current
Conditions of the equipment with grounding
Maintenance and Inspection Manual
1. Externals, connection tubes, and cables
Inspection item Inspection method Criteria Note

(1) Conditions of Visual inspection. OK if the equipment functions The water supply opening
connection tubes. normally and Drainage opening must
(bending, etc.) be closed with a metallic
band.
(2) Connection to the drain Visual inspection. OK if the equipment functions Length of the drain tube: <3
pipe. normally m
Height at the tip of the drain
tube: <60 cm.
(3) Presence of damage Visual inspection. Must not be failure and corrosion
and connection of
cables.
(4) Conditions of the Visual inspection. Must be connected to a 3P outlet
grounding conductor.
(5) Damage/deformation Visual inspection. Must not be damaged/deformed
that interfere with OK if operation normally
functions.
(6) Conditions of the light Visual inspection. Red, Yellow, Green and Blue
indicator. blink on startup.
2. Water supply, concentrate feeder, and drainage areas

(1) Conditions of tubes. Visual inspection. OK if the equipment functions
(bending, etc.) normally
Exchange the tube with leakage
and central system line.
(2) Movement / loosening Check the movement from Must have the movement sound
of the solenoid valve. on the screen. OK if screws is not loosening.
(3) Movement of the While water is supplied to Reducing valve pressure must The accuracy of indicated
reducing valve. the equipment, turn on be value of PD should be
V1,4,10,35,and 55. Leave 257 to 287mmHg confirmed by calibrator.
them for approx. 30 sec ( 34 to 38 kPa)
and turn OFF V4. Measure
the pressure by PD value.
(4) Movement of the Collect the dialysate from Must be the specified PO2 that Water supply should be
degassing part. the sample port during the is below 140 mmHg pO2=200mmHg
preparation complete
process.
(5) Movement of the Visual inspection during the Water should not exit from the
degassing tank. preparation complete air side
process.
(6) Conditions of sheath Visual inspection during the No fluid leakage
type rinse ports. rinse process.
(7) Stain, leakage, or Visual inspection. Must have no stain, leakage, or
blockage in filters. blockage
3. Closed line area

(1) Movement / loosening Operate the equipment Movement sound must be
of the solenoid valve. manually, touching the audible
screen. OK if screws is not loosening.
(2) Movement and leakage Inspect visually when Pumps rotate smoothly
in concentrate/UF concentrate/UF pumps are
pumps. working.
(3) Movement during gas Short line the FSW Dialysate pressure must be Adjust using NV7
purge. connector during the 50±50mmHg To increase; loosen NV7
preparation complete and (0 to 13.3 kPa) To decrease ; tighten NV7
operate gas purge.
4. Disinfectant/acid solution feeder areas

(1)Movement / loosening of Operate the equipment Movement sound must be
the solenoid valve. manually, touching the audible.
screen. OK if screws is not loosening.
(2)Residual Collect a sample from the Must be no residual by test
disinfectant/acid solution. drain just before end of the paper or test chemical.
process.
(3)Conditions of the tube. Visual inspection. OK if the equipment functions
(bending, etc.) normally.
5. Blood pump area

(1) Loosening and Check the externals and The rotating part should not be
abnormal sound in the sound. loose or have abnormal sound.
rotating part.
(2) Consistency between Measure the actual flow When the display is 140, actual Use water and measure the
displayed and actual volume using the blood flow volume must be 126 to 154 flow volume per min with an
flow volumes. line. mL/min. When the display is electric balance.
330, the actual flow volume must
be 297 to 363 mL/min.
6. Syringe pump area

(1) Movement of the Push the pusher manually Must move smoothly. Apply grease on the feed
syringe pump to free the system screw part.
Grease No.: MOLYKOTE
BR2 Plus Grease (DOW
CORNING)
(2) Loosening of the Tighten the set screw on OK if not loose
syringe pump pulley the pulley.
(3) Consistency between Run over 30 min at Pusher travel distance should be Turn off syringe size and
displayed and infused 9.9mL/hr with 20mL syringe 0.542～0.598mm/min. adjust “SYRINGE RATIO,” if
volumes. the difference is larger.
7. Electric tests

(1) Short circuit breaker Operate the switch to OK if power supply shuts off.
operation. check the short circuit
breaker.
(2) Battery capacity for Attach the blood line on the The blood pump and heparin Set the blood pump flow at
power failure backup. blood pump and air bubble pump must operate for >20 min. 150 mL/min.
detector. Turn on the NOTE: It must operate for 20 Set the heparin pump flow at
BLOOD PUMP and min, considering the time it takes 2.0 mL/h.
HEPARIN PUMP switches. to complete blood collection in Start after charging for 48
Turn off the equipment case of power failure. This time hrs.
breaker. frame may vary, depending on A new battery allows approx.
the age of the battery. Exchange 30 min of operation with full
Mute the buzzer by the battery if necessary. charge. The battery gradually
pressing the MUTE/RESET deteriorates although there is
switch. Check the following function: no power failure.
· Air bubble detector is on
At the same time, check: The blood pump must stop when
· Air bubble detector the sensor detects air bubbles.
Remove the blood line from
the air bubble detector.
(3) Leakage current. Connect the jig to measure OK if <0.5 mA. The jig to measure leakage
leakage current to the current is necessary.
equipment. Measure the The standard of the jig must
current in the protective be in accordance with
earth conductor (the IEC60601-1.
grounding conductor of the
power plug) during normal
operation.
(4) Conditions of the Use a tester to measure OK if <1  The power breaker must be
equipment with the resistance between the turned OFF.
grounding. chamber frame and the
grounding terminal.
8. Movements of monitoring and indication alarms

(1)Temperature-related Compare preset and Difference must be
alarms. (calibration of displayed temperatures in <±0.5 C
temperature indication) the preparation complete
process.
(2) Dialysate conductivity Compare displayed Difference must be
alarm. conductivity and actual ≤ 0.2 mS/cm.
(calibration of conductivity in the
conductivity preparation complete
indication) process.
(3) Venous pressure Apply pressure in Dialysis Activate the limit alarm.
alarm.(calibration of waiting process.
the venous
pressure gauge)
(4) Arterial / P-D pressure Apply pressure in Dialysis Activate the limit alarm.
alarm.(calibration of the waiting process.
arterial pressure gauge)
(5) Dialysate pressure Change the alarm range Alarm is active when the current
alarm.(calibration of manually in the preparation level is out of range.
the dialysate complete process.
pressure gauge)
(6) Blood leak alarm. Set the temperature to Real Blood leak value must be
(movement of the 36.5 °C in the preparation <150.
blood leak detector) complete process. Read
the Real blood leak value.
(7) Air bubble error After patient connect in Alarm is active. CLV
alarm. preparation complete SPR unit (option)
(movement of the process, remove the tube
air bubble detector) after BP rotate the setting
value (default value is 20
ml).
(8) Blood detection alarm Blocking the blood sensor Alarm is active. CLV
(movement of the bloo during priming. SPR unit (option)
d detector) Blood detector of SPR
responds in flow monitor
screen when cover is opened
during rinse standby process.
(9) Insufficient water Operate the unit after Alarm is active.
supply. decreasing the water
supply to an insufficient
level.
(10) Alarm buzzer Check the buzzer sound. OK if buzzer sound is normal.
(11) Blood leak alarm. Install a simulated blood The Real blood leak value is the
(calibration of leak filter. Read the Real total of the specified value of the
blood-leak blood leak value. dummy simulated filters ±80
detection) ppm.
9. Other items to inspect

(1) Bending, leakage, Visual inspection. OK if the equipment functions
staining, etc. of tubes. normally.
Exchange the tube with leakage.
(2) Abnormal sound / smell. Check sounds and smells. OK if no abnormal sounds /
(STANDBY, DIALYSIS, smell are present.
RINSING)
(3) Presence of air bubbles Visual inspection during the No air bubbles in the hydraulic
in the hydraulic line preparation complete line
process.
(4) Leakage from the Perform the start-up test. Test must be completed without
hydraulic line. a problem.
(5) Filling flow rate. Check the time of 「FS1」 The supply time must be 6.5 to
in the flow monitor screen 7.0 seconds.
during preparation
complete process.
(6) Filling complete Measure the pressure on The pressure must be 100 to
pressure. the branch of V5a and V7a. 120 kPa (1.0 to 1.2 kgf/cm2)
when filling is complete.
(7) Dialysate flow rate. Set the dialysate flow The supply time must be 7.5
800mL/min. Measure the seconds.
supply time of one
chamber.
(8)Tightening the terminal Check the tightening. OK if not loose. The power breaker must be
block. turned Off
10. Substitution pump area (Option)

(1)Loosening and abnormal Check the externals and The rotating part should not be
sound in the rotating part. sound. loose or have abnormal sound.
(2) Consistency between Measure the actual flow When the display is 140, actual Use water and measure the
displayed and actual volume using the blood flow volume must be 126 to 154 flow volume per min with an
flow volumes. line. mL/min. When the display is electric balance.
330, the actual flow volume must
be 297 to 363 mL/min.
11. Powder Bicarbonate Assy (Option)

(1) Movement of the Check the movement, Must have the movement sound
solenoid valve. touching the screen.
(2) Bending, leakage, Visual inspection. OK if the equipment functions
staining, etc. of tubes. normally.
Exchange the tube with leakage.
(3) Damage/deformation Visual inspection. Must not be damaged/deformed
that interfere with
functions.
(4) Stain, leakage, or Visual inspection. Must have no stain, leakage, or
blockage in filters. blockage
12. BPM area (Option)

(1)Stain, leakage, or Visual inspection and check Must have no stain, leakage, or
blockage in air filters. the movement of BPM blockage.
Must measure normally without
alarm.
1. Unit configuration
1.1. Overall views
7
1.1.1. Names of parts and their functions
1 8
2 9
3 10
4 11
5 12
6 13
Figure1-1 Overall views (Front-right side view)
Name Function
1 Operation panel Setting the machine and operate the each process.
2 Heparin pump Syringe pump to infuse heparin at a selected rate
3 Blood pump Circulates blood in the blood circuit.
Substitute pump
4 Circulates blood in the dialysate circuit.
(Factory option)
5 Front cover Access to the hydraulic circuit of the machine.
Concentrate rack
6 Support the A and B concentration tank.
(Option)
7 Light indicator Indicates processes and alarms by 4 color light.
8 Hook For bags and containers.
9 IV pole Supports dialyzer, etc.
10 IV pole fixed screw Fixes the infusion stand.
11 Pole holder The support to hold the infusion pole.
12 Right side cover Access to the hydraulic circuit of the machine.
Disinfection bottle rack
13 Support the disinfection tank.
(Option)
1-1
1
3
8
4
9
10
11
Figure1-2 Overall views (Rear-left side view)
Name Function
IC card reader writer
1 Leading and writing the IC card.
（Option）
2 Tray Tray for small material.
Connect the cuff specified by manufacture.
3 Cuff connector
Refer「13 Blood pressure monitor」
4 Fan filter Cools the power supply.
5 Nurse call connector Connect the nurse call switch specified by manufacture.
6 NIBP remote switch connector Connect the NIBP remote switch specified by manufacture.
7 Power cord Electric power connection.
8 Powder bicarbonate cartridge holder Support for the bicarbonate cartridge.
9 LAN connector Connect the network system specified by manufacture.
10 Power breaker Power switch of the unit.
11 Left side cover Access to the hydraulic circuit of the machine.
1-2
! CAUTION
 Do not connect any external connection equipment other than the maker-specified. Doing so
may cause malfunction or breakage of the equipment.
 As for external connection equipment, connect such equipment in accordance with applicable
IEC standards.
(Example: IEC60950-1 for data processing equipment or IEC60601-1 for medical equipment)
All equipment configurations must comply with IEC60601-1-1. Personnel in charge of external
equipment connection must take responsibility for the medical system configuration to meet the
requirements of IEC60601-1-1. In case of any question or doubt, contact your nearest branch
or sales office.
1-3
5
6
1
2 7
3 8
4 9
Figure1-3 Overall views (Rear side view)
Name Function
1 Disinfectant connector Connector to the disinfectant tank.
2 Acid cleaning connector Connector to the Acid cleaning connector tank.
3 Water supply opening Supply water inlet.
4 Drainage opening Drain outlet.
ETRF1 cover
5 Cover for ETRF1 (CF-609N).
(Option)
ETRF2 cover
6 Cover for ETRF1 (CF-609N).
(Option)
7 Fan Cools the electric parts in dialysate circuit during hot rinse.
Central port B1(A1)
8 Connector to the central supply solution.
(Option)
Central port A1(A2)
9 Connector to the central supply solution.
(Option)
1-4
1.2. Operation panel
1.2.1. Names of parts
2 4
3 5
Figure 1-4 Operation panel (Overview)
Name Function
Turn on the power breaker on behind and I/O power key, the machine
can be used to operate.
1 I/O power key
Turn off the I/O power key, the machine stop all function. (However
the part of circuit for charging to battery is powered.)
2 I/O indicator Light once the machine boot up.
3 Power indicator With electricity: green. Without electricity: turn of the light.
4 Touch panel Display the operation button, several information and setting.
Blood flow rate can be set by rotating blood pump flow setting dial.
5 Blood pump flow setting dial Rotate the dial CW, blood flow is increased 5mL/min each.
Rotate the dial CCW, blood flow is decreased 5mL/min each.
! CAUTION
 The liquid crystal screen is fragile. Extra care should be taken to avoid pushing or scrubbing the
surface with a pointing or hard object.
 The liquid crystal screen is made of glass. Extra care should be taken to avoid any mechanical
impact on the screen.
 When a switch or the liquid crystal in the touch panel breaks, turn of the “I/O” switch immediately
to stop treatment and separate a patient from the unit.
 The TFT color liquid crystal panel is manufactured using a high precision technology. Some
pixels on the screen, however, may not light or light at all the time. Additionally, uneven color or
irregular brightness may be seen from particular angles. They are due to the structure of the
liquid crystal display, this is not a malfunction.
1-5
I/O power key
The device will be ready for use when the power breaker at the back of the device and the I/O
power key at the front are pressed. A green light will be lit when the I/O power key is pressed.
Turning the I/O power key off stops all functions of the device. Power failure backup operation
stops also.
The I/O power key must be pressed for more than 3 seconds.
NOTE
* The following is relationships between the power breaker and the I/O power key:
I/O power key
ON OFF
Stops operation
ON Normal operation
Power Battery charged
breaker Blackout Stops operation
OFF
operation Battery not charged
When “Memory back up” is set to ON, a system status at the time of I/O power key off is stored so
that the following status is restored when the I/O power key is turned ON next (to start the system).
When the I/O power key is turned off after patient connection, device restored from the state before
the I/O power switch is turned off.
! CAUTION
* Before restarting operation, always check information in the message. After restarting operation
as well, always check setting parameters and status of switches related to treatment.
1-6
1.3. Blood circuit components
1.3.1. Names of parts and their functions
12
2
3
13
4
14
5
6
15
16
8
9
17
10
11
Figure 1-5 Blood circuit installation component
Name Function
1 Syringe holder The support for the heparin infusion syringe.
2 Syringe stopper The lever that holds the syringe into the syringe holder.
3 Tube guide Prevent the come out of blood tube.
4 Lever Connect the rotor and the motor shaft.
5 Blood pump rotor Occlusive roller pump to circulate the blood in the blood circuit.
6 Substitute port (Option) Connect to the substitution line for sucking the online dialysate.
To be used automatic priming and reinfusion by using saline or online
substitute.
SPR Unit
7 Saline clamp
(Factory option)
Arterial clamp
8 Dialysate collector Dialyzer filter outlet connector.
1-7
Name Function
9 Dialysate feeder Dialyzer filter inlet connector.
10 Sample port Used to take samples by syringe.
11 Drain port Connect to drain spent dialysis solution.
12 VP receiver Connection for the venous pressure measurement.
13 AP(PFI) receiver Connection for the arterial pressure or PFI measurement.
14 Switch to detect no syringe Detect not to set the syringe.
Detects air bubbles and blood in the blood circuit.
In case of detect air bubble, clamp the blood flow.
Venous side bubble sensor, Bubble detector

15
blood sensor / clamp part Blood sensor
Venous clamp
16 B concentrate suction tube Nozzle for B concentrate.

A concentrate / acetate suction
17 Nozzle for A concentrate or acetate.
tube
1-8
2. Message display monitor
! CAUTION
 Some button operation cannot be accepted on some screens or during some processes.
2.1. At machine start-up
2.1.1. START-UP screen
Model name and software version are displayed.
--->
2.1.2. Selection screen
Select "Treatment mode" or "Cleaning mode".
1 2
No. Name Function
1 Treatment mode button Button to go to Treatment mode
2 Cleaning mode button Button to go to Cleaning mode
2-1
2.2. Treatment screen
1 2 3 4 5 6 7
16 9
10
11
17 12
13
18
14
15
19 20 21 22 23 24 25 26
No. Name Function

1 Operating mode Operation mode is displayed (i.e. On-Line HDF).
2 Preparation button Button to go to Treatment process from Preparation complete
process and Reinfusion process.
3 Treatment button Button to go to Reinfusion process from Treatment process.
4 Bypass button Button to run dialysate via bypass during Preparation
complete process, Treatment process and Reinfusion
process.
5 UF stop button Button to drain dialysate during Preparation complete process
or and Reinfusion process.
Drain button The UF STOP button stops ultra filtration operation during the
dialysis process.
6 Cleaning button Button to go to Cleaning mode from Preparation process,
Preparation complete process and Reinfusion process.
7 MUTE/RESET button The MUTE/RESET button mutes or resets the buzzer sound
when alarm is going off.
8 Priming Support button Button to open Priming screen.
2-2
No. Name Function
9 First aid button If this button is pressed, some predetermined operations start.
Active only during Treatment
During reinfusion, it changes to Dia/BTS Exchange button and
the dialyzer and blood circuit can be exchanged in the middle
of treatment.
10 Heparin button Button to open menu screen about heparin.
11 BPM button Button to start or stop blood pressure measurement.
12 System button Button to open System setting screen.
13 Function button Button to open Function screen.
14 Blood flow Display box for blood flow.
15 Blood pump button Button to start or stop blood pump operation.
16 Pressure display Display boxes for actual arterial pressure, venous pressure
and TMP/dialysate pressure.
Touch the display box to open the Alarm Setting window.
17 Conductivity display Display boxes for actual dialysate conductivity and B
concentrate conductivity.
Touch the display box to open the Alarm setting window.
The alarm setting values are not able to change.
18 Temperature display Display box for actual dialysate temperature.
Touch the display box to open the Alarm Setting window.
The alarm setting values are not able to change.
19 Alarm button Button to display alarm, warning and information such as
startup test result, operation manual and so on.
20 Guidance button Button to display guidance.
21 Monitor symbol button Button to disable button operation for a specified time
22 Level adjust button Button to open level adjust screen.
23 UF menu button Button to open UF menu screen.
24 Dialysate menu button Button to open Dialysate menu screen.
25 Subs. menu button Button to open ONLINE HDF/HF and substitution menu
screen.
Option ONLINE HDF; see chapter 12 option
26 SN menu button Button to open SN (single needle) menu screen
2-3
2.3. Examples for data entry (Treatment data)
Example: Arterial pressure alarm setting
2 4 5
3
No. Name Function/Operation
1 Arterial pressure display Touch the Pressure display box. The Alarm setting window
will appear.
2 Width setting switch Switch to change display range (width).
3 +/- switch Switch to set the upper and lower limit for alarm
4 Enter button Button to confirm the setting
5 Cancel button Button to cancel the setting.
2-4
Example: UF goal setting
3 4

1 UF goal display Touch the UF goal display box. UF goal setting window will
appear.
2 +/- switch Switch to set the value for each digit
3 Cancel button Button to cancel setting change
4 Enter button Button to confirm setting
2-5
2.4. Heparin screen
1 2 3
4 5 6
7 8 9

1 Flow rate Display box for heparin flow.
2 Heparin stop time Heparin stop time is displayed.
Heparin stop time can be set by touching the stop time
display box.
3 Pump button Button to start or stop heparin pump operation.
4 Syringe size Display box for syringe size.
5 Cum. F.F vol. Cumulative F.F. infusion volume is displayed.
6 F.F button Button to start or stop heparin pump F.F. infusion operation.
7 Bolus one shot One shot infusion volume is displayed.
One shot infusion volume can be set by touching the volume
display box.
8 Cum. bolus vol. Cumulative one shot infusion volume is displayed.
9 Bolus button Button to start or stop heparin pump one shot infusion
operation.
2-6
2.5. Level adjustment screen

1 Level adjust switch Switch to adjust liquid level
2-7
2.6. Screen saver (Silent - screen)
Data displayed
- UF volume, UF rate, UF goal
- Arterial pressure and Venous pressure
- Blood flow
- UF start time, UF remaining time, and UF goal time
- Blood Pressure Monitor (only when Blood pressure option is selected.)
This screen is activated during periods of user inactivity on the Treatment screen.
Time to activate can be set by an operator.
This screen disappears:

- when screen is touched
- when information or alarm should be displayed.
- when blood pressure starts to be measured.
2-8
2.7. Priming screen
4
1
5
2
6
7 3

1 Type of priming Button to select priming type.
(Auto or Manual, NaCl or Online)
2 Start/Stop button Button to start/stop priming.
3 Circulation button Button to start/stop circulation after priming complete.
4 Priming volume display Target priming volume is displayed.
Target priming volume can be set by touching the priming
volume display box.
5 Priming time display Priming remaining time is displayed.
6 Cum. volume Cumulative priming volume is displayed.
7 Status display Manu: Priming achievement is displayed.
Auto: Status of each step is displayed
2-9
2.8. Reinfusion screen
4
1
5
6 2
7
8 3

1 Type Button to select reinfusion type.
(Auto or Manual, NaCl or Online)
2 Start/Stop button Button to start/stop reinfusion.
3 Emptying button Button to open Auto emptying screen.
4 Arterial volume Target reinfusion volume is displayed.
Target reinfusion volume can be set by touching the
reinfusion volume display box.
5 Venous volume Reinfusion remaining time is displayed.
6 Achievement Reinfusion achievement is displayed.
7 Cum. volume Cumulative reinfusion volume is displayed.
8 Achievement Reinfusion achievement arterial line and venous line are
displayed.
2-10
2.9. Cleaning standby screen
2
3
1
4
5
7 8
1 Cleaning mode button Button to select cleaning program/type
2 Remaining time Cleaning execution time is displayed.
3 Auto off button When the Auto off button is ON, machine is automatically
turned off after cleaning is completed.
4 Treatment mode button Button to go to Treatment mode by touching more than 1
sec.
5 Start button Button to start cleaning
This button changes to Stop button during cleaning.
6 Weekly program button Button to weekly program setting.
7 History of cleaning Cleaning history is displayed.
(or Concentration setting) Able to move to Concentration setting window when
disinfection or decalcification is selected.
8 PRG guide display Items of currently selected cleaning program is displayed.
2-11
2.10. Cleaning execution screen for single step (Rinse)
1
Under Hot disinfection or Hot rinse
Under Water rinse Under disinfection or de-calcification

1 Cleaning graph Graph of Cleaning execution time and Cleaning solution
temperature are displayed.
2 Remaining time Cleaning remaining time is displayed.
2-12
2.11. Cleaning execution screen for program (Program 1)

1 Cleaning program Cleaning program is displayed.
2-13
2-14
3. Preparation
3.1. Turning on the NCU-18
1. Establish the water and power supply. (power breaker)

2. Press and hold the I/O power key until it beeps. (for 3 seconds).
3. To boot up NCU-18 takes approx.75 seconds. During this time, screen shows the machine type,
the current software version for approx.10 seconds. Mode selection screen is displayed when
booted.
! DANGER
 Verify that the system had a sufficient cleaning or disinfection.
 Before going to preparation verify that no amount of fluid remains in the system that can harm
the health of the patient.
 Sample can be taken at the blue coupler and the substitution port, using the test method
corresponding to the used disinfectant. If the test shows a residual concentration or in event of a
positive pH reaction (acid based disinfectants pH≤4.5) restart a cleaning program.
 For peracetic acid based disinfectants use for example a peracetic acid test method
 For sodium hypochloride based disinfectants use for example a potatium iodide starch paper
 For citric acid based disinfectants use for example determination of the ph
 Observe the “use by” date of the indicator paper!
 Refer to chapter 6 cleaning
3.2. Concentrate supply
! WARNING
 The concentrates are calibrated at first installation into different types (BCx)
 For treatment make the correct choice according to the programmed concentrate types this is
done in the dialysate menu.
! CAUTION
 Never use acid concentrate for acetate dialysis.
 Verify the label of the canister before use.
 Using acid concentrate for acetate dialysis will endanger the patient during treatment because of
differences in dilutions compared with acetate concentrate.
 Because no BIC is used, the acid concentrate has no buffers to the safety of the patient.
 Only use concentrates prescribed by a physian
3-1
Bicarbonate dialysis
To connect the acid container

1. Open the concentrate flap.
2. Place the red concentrate suction tube into the acid container.
3. Close the concentrate flap.
To connect the bicarbonate container

1. Open the concentrate flap.
2. Place the blue concentrate suction tube into the bicarbonate container.
3. Close the concentrate flap.
OR
To connect the B-cartridge (Option)
1. Open the B-cartridge arms.
2. Attach the NIPRO B cartridge.
3. Close the B-cartridge arms.
Open the B-cartridge arms. Depress the holder button and With supporting the cartridge by
open the holder arm to the hand, depress the holder button
position indicated in the upper and lower the holder arm to the
illustration. position indicated in the upper
illustration.
! CAUTION
 Only the B-cartridge supplied by NIPRO may be used.
 Make sure that the canister used contains enough concentrate and bicarbonate necessary for a
complete dialysis treatment.
 Ensure that the concentrate displayed on the screen comply with the specifications mentioned
on the acid canister. Assure that all settings are applied correctly. Any mistake can be danger for
the patient.
3-2
3.3. Preparation
1. Press the "Treatment mode" button.

2. Select the treatment mode in "Subs." menu screen.
3. Press the "Preparation" button.
4. An alarm sound is to be heard, to confirm the working condition of the acoustic alarm.
5. Start-up test starts.
6. Preparation process starts when the start-up test is completed.
! CAUTION
 If no alarm sound is to be heard, there will also be no acoustical alarm sound during treatment,
either. In this case, do not make any treatment.
 The start-up test must have been completed successfully without fail before every treatment.
 Only use dialyzers with CE marking and correct fittings
 Hydrophobic filters must be used on the pressure lines of tubing systems to prevent (cross-)
contamination.
 In case a hydrophobic filter gets wet, is blocked or penetrate throw you have to exchange the
tubing system. Up to the position it could be possible to use instead a pressure measurement
line with Lure lock connector. In this case clamp the defective line. If the pressure measurement
units are contaminated (e.g. contact to blood), then all affected parts must be disinfected or
replaced.
3-3
3.4. Extracorporeal blood circuit with saline bag
Setting the arterial and venous blood circuit.
1. Setting the arterial blood circuit.
・Insert the arterial chamber into the arterial chamber holder.
・Connect the arterial pressure line to the arterial pressure port.
・When there is an SPR option, insert the arterial blood line into the SPR unit.
・Insert the arterial pump segment into the blood pump.
・Connect the arterial blood line to the dialyzer.
・Connect the saline line to the saline bag.
(with no SPR option) (with SPR option)
2. Setting the venous blood circuit.

・Insert the venous chamber into the venous chamber holder.
・Insert the venous blood line into the venous clamp box.
・Connect the venous pressure line to the venous pressure port.
・Connect the venous blood line to the dialyzer.
(with no SPR option) (with SPR option)
3. Connect the arterial and venous patient access to Y shaped tube, then connect the tip of Y
shaped tube to the drain port or put somewhere to be able to drain.
NOTE
 When Drain port is not used, change “Drain port use” to “OFF” on the <Setting-9.Pri.rein>
screen in the System menu.
3-4
3.4.1. Priming of blood circuit (with no SPR option)
Setting the priming window

1. Press the priming button to display the priming window.
2. Set a rinse volume.
3. Set a flow amount with the blood pump flow setting volume.
NOTE
 The rinse volume and the flow of the blood pump are automatically set to the default value each.
Change the rinse volume and flow of the blood pump, if necessary.
Priming the arterial line

1. Open the clamp of the saline line.
2. Fully rinse the arterial line up to the connector end by utilizing a saline flow caused by a drop,
and fill the line with saline.
3. Close the arterial line end, using forceps, to stop the flow of saline.
Priming the venous line

1. Press the “Start” button in the priming window.
2. (The saline rinses the blood circuit inside fully through the blood pump.)
Interruption of the priming process.

1. Press the “Stop” button in the priming window.
2. To continue priming, press the “Start” button.
! CAUTION
 Do not connect a patient if the prescribed volume has not been reached.
 The rinse volume depends on the manufacturer’s specifications.
Completing the priming process

1. When the prescribed rinse volume is reached, the blood pump is stopped and the priming
process is finished.
2. To continue the priming process further, increase the rinse volume to set. Then press the
“Start” button to restart the priming process.
3. Change the dialyzer upside down. Set the arterial side (red) up and the venous side (blue)
down.
3-5
3.4.2. Priming of blood circuit (with SPR option)
Starting the priming

2. Select the priming mode, "Auto" or "Manual".
3. Select the "NaCl" mode.
4. Set the rinse volume
5. Set the flow of the blood pump
NOTE
 The rinse volume and the flow of the blood pump are automatically set to the preset value.
Change the rinse volume and the flow of blood pump if necessary.
 Check the connection of arterial port and venous port, before priming process is start.

! CAUTION
 Do not connect a patient if the prescribed priming volume has not been reached.
 The prescribed priming volume of dialyzer depends on the manufacturer specifications.
Complete the priming process

1. When rinse volume achieved, blood pump stops and priming process is completed.
2. In case of continue priming, increase the priming volume. Then press the “Start” button to
restart the priming process.
3-6
3.5. Extracorporeal blood circuit with online solution (with SPR option)
Setting the arterial and venous blood circuit.

1. Setting the arterial blood circuit.
・ Insert the arterial chamber into the arterial chamber holder.
・ Connect the arterial pressure line to the arterial pressure
port.
・ Insert the arterial blood line into the SPR unit.
・ Insert the arterial pump segment into the blood pump.
・ Connect the arterial blood line to the dialyzer.
・ Connect the saline line and the substitution line to Y-tube
and connect the end to the substitution port.
2. Setting the venous blood circuit.

・ Insert the venous chamber into the venous chamber holder.
・ Insert the venous blood line into the venous clamp box.
・ Connect the venous pressure line to the venous pressure
port.
・ Connect the venous blood line to the dialyzer.
3. Setting the substitution circuit.

・ Open the substitution pump cover to set the substitution
circuit.
4. Connect the arterial and venous patient access to Y shaped tube, then connect the tip of Y
shaped tube to the drain port or the drain bag.
NOTE
 When Drain port is not used, change “Drain port use” to “OFF” on the <Setting-9.Prep./rein.>
screen in the System menu.
3-7
3.5.1. Priming of blood circuit
Starting the priming

2. Select the priming mode, "Auto" or "Manual".
3. Select the "Online" mode.
4. Set the rinse volume
5. Set the flow of the blood pump
NOTE
 The rinse volume and the flow of the blood pump are automatically set to the preset value.
Change the rinse volume and the flow of blood pump if necessary.
 Check the connection of arterial port and venous port, before priming process is start.
 If HDF/HF is selected in the treatment mode, perform priming of the substitution line in the Auto
mode.
 If performing priming of the substitution line in the Manual mode, operate the substitution pump
manually from the “Subs” menu screen.

! CAUTION
 Do not connect a patient if the prescribed priming volume has not been reached.
 The prescribed priming volume of dialyzer depends on the manufacturer specifications.
Complete the priming process

1. When rinse volume achieved, blood pump stops and priming process is completed.
2. In case of continue priming, increase the priming volume. Then press the “Start” button to
restart the priming process.
3-8
3.6. Circulation process
Starting the circulation process

1. Clamp the end of Y tube connected with puncture devices of arterial and venous sides and loop
the arterial and venous sides.
2. Press the Circulation button in the priming window.
Interruption and restart of the circulation process

1. Press the Circulation button.
2. Press the Circulation button to continue circulation.
Completing the circulation process

1. Press the Circulation button.
2. Change the dialyzer upside down. Set the arterial side (red) up and the venous side (blue)
down.
3.7. Dialyzer filling
NOTE
 ”Preparation complete" is displayed on left upper of screen when preparation process is
completed.
1. Confirm that the machine is preparation complete.

2. Open the coupler flap.
3. Connect the blue coupler to the dialysate inlet port of the dialyzer.
4. Connect the red coupler to the dialysate outlet port of the dialyzer.
5. Close the flap.
6. Change the dialyzer upside down. Set the venous side (blue) down and the arterial side (red)
up.
7. The message "Please connect to the patient" that to connect to patient is displayed when
setting time is passed.
3-9
3.8. Adjusting the drip chamber liquid level
Adjustment by the liquid level adjustment function

The function that is used to adjust the level of the liquid surface of the drip chamber
venous / arterial blood circuit.
1. Press the "Level adjust" switch.
 The windows for level adjustment

appears.
2. Adjust the chamber level by operating

the "▲（Up）" / "▼（Down）" switch at
"ART chamber" / "VEN chamber".
 The level adjustment works as pressing

the switch. It stops if not be pressed. It
stops automatically when hold the
switch for a certain period. To
resume adjustment, press the switch
again.
Adjustment manually by syringe.

1. Dismount the cover of the liquid level adjustment line of the arterial drip chamber and connect
the syringe.
2. Adjust the air, using the syringe, until the liquid reaches an appropriate level.
3. Dismount the syringe and close the cover of the liquid level adjustment line.
4. Adjust the liquid level of the venous drip chamber in the same procedure as that of the arterial
side.
ＮＯＴＥ
 For filling the drip chamber with saline, there is another method in which the drip chamber is
turned upside down before priming.
! CAUTION
 Always turn the drip chamber upside down even when using the arterial drip chamber by filling it
with liquid.
 If the drip chamber leaks, replace the blood circuit with a new one.
 For details of handling the blood circuit, refer to the blood circuit instruction manual.
3-10
3.9. Setting treatment data
! CAUTION
 Check that the treatment parameters are as intended after setting.
Setting the UF parameters

1. Press the UF menu button.
2. Enter the desired ultra filtration setting.
NOTE
 The various treatment parameters for the individual patient must be taken into consideration
before every treatment.
Setting the Dialysate parameters

1. Press the Dialysate menu button.
2. Enter the desired dialysis setting.
Setting of heparin pump

1. Press the Heparin button.
2. Enter the desired Heparin setting.
NOTE
 Up to the setting:
The heparin pump is automatically turned on when the blood pump is turned on.
Setting the UF profiles and concentration profiles

1. Press the profile button in the dialysate menu.
2. Enter the desired UF profiles and concentration profiles setting.
NOTE
 The default concentration and UF profiles exist as 8 basically different profiles with step change.
Step counts can be modified in the “Profile division number” of “System-Setting-Characteristics”.
 The Step time is decided, dividing the Treatment time remaining by 8.
 When you use the concentrate- and UF-profiles in combination: the steps will always be linked.
3-11
3-12
4. Treatment
4.1. Start of treatment
! WARNING
 Back filtration may occur with high flux dialyzer with low or zero UF rates due to pressure gradients.
! WARNING
 Check blood leak frequency during dialysis because venous pressure sensor error is ±10mmHg
though limited sensitivity of the sensor is 1mmHg and the machine is provided with protective system
designed to minimize the error.
 Venous pressure monitoring is not a reliable method of detecting a detached needle.
4.1.1. Patient connection
1. The message "Please connect to the patient" that to connect to patient is displayed when dialyzer
filling is completed.
2. If turning in priming circulation mode: press the circulation button to stop the pump.
When "Clean-Treatment-Start" of "System-Setting-Prep./Rein." is "ON";

3. Pressing "OK" button in the message of to connect patient shows "Drain the solution in the blood line
with Clean-Treatment-Start? Yes/No".
4. When "Clean-Treatment-Start" function is not used, ordinary patient connect is performed. Connect
the arterial line to the patient, set the blood pump flow and select "No"'. Refer to post-No.5 procedure
"when "Clean-Treatment-Start" setting is "OFF" " for the further procedure.
5. Connect the arterial and venous lines to the patient and select “Yes” when "Clean-Treatment-Start"
function is used.
6. Blood pump and UF pump start operation with the set flows and blood removal starts.
7. Blood removal stops automatically once it reaches the set volume. It is also possible to perform the
reinfusion additionally, following the guidance on the screen. Selecting “CTS Completed" exits the
blood removal screen.
8. Press the treatment button to start treatment.
When "Clean-Treatment-Start" of "System-Setting-Prep./Rein." is "OFF";

3. Connect the arterial line to the patient.
4. Set the blood flow to the desired value, then press "OK" button in the message of to connect patient.
5. Blood pump starts to rotate, blood removal starts.
6. Press the blood pump on/off button to stop the pump, connect the venous line to the patient.
When the blood sensor of arterial side detects blood, “Blood detected. Arterial and Venous lines are
connected?” message is displayed and the blood pump stops automatically.
7. Press the treatment button to start treatment.
NOTE
 Heparin pump is started automatically, if preset in the setting.
4-1
4.2. Single-Needle Click-Clack
Use this function exclusively for some cases, for example when stroke volume and re-circulation volume
are significantly different. For the display of effective blood volume, 2 ml of re-circulation volume every
Single-Needle Click-Clack cycle is taken into consideration when standard DN dialysis cannula is used.
However actual re-circulation volume may differ from the display volume if another type of cannula is used.
The arterial and venous lines should be connected to the vascular access together with Y shaped tube.
! CAUTION
 During preparation process, Single-Needle Click-Clack is available only when the rinse volume
becomes minimum volume.
 You can start or stop Single-Needle Click-Clack any time during Double-Needle treatment.
 HDF being executed is stopped. Treatment continues by HD.
 On-line bolus can be injected any time.
 Reinfusion is available when ONLINE option is selected.
4.3. To Start Single-Needle Click-Clack
(1) Be sure to use the needle and the blood circuit specifically prepared for S/N before performing the
S/N operation.
(2) Check the settings of required setting values in advance before performing the S/N operation.
4.3.1. Setting values required for the S/N operation
! WARNING
 The S/N operation repeats blood collection and reinfusion based on the venous pressure. Improper
setting value results improper blood collection and reinfusion. Set the proper value based on the
physician’s instruction.
4-2
4.3.2. SN menu
2
3
4
5
6
7
Setting Selection
No Setting item Default Setting step
range item
1 Click clack button - - - ON/OFF
2 S/N press high change point 200 100-350 10 －
3 S/N press low change point 50 20-150 10 －
4 S/N alarm low stroke time 20 5-30 1 －
5 S/N stroke volume min 10 OFF,5-100 1 －
6 Effective blood flow 0 －－－
7 Average stroke volume 0 －－－
Display Description
・The value of upper switching limit during single needle can be set by using
this "S/N PRESS. HIGH CHANGE POINT".
S/N press high change point ・When S/N switch is turned ON, the value of higher switching limit during
single needle is fixed as this value with regardless of current venous pressure
value.
・The value of lower switching limit during single needle can be set by using this
"S/N PRESS. LOW CHANGE POINT".
S/N press low change point
・When S/N switch is turned ON, the value of lower switching limit during single
needle is fixed as this value with regardless of current venous pressure value.
4-3
Display Description
・It can be implemented the alarm setting about time to need for retrains
operation during single needle operation. It is set maximum time to reach
single needle lower switching value from upper switching value.
・Regarding the alarm setting value for the time to need for collection of blood
(from patient's body to extracorporeal circuit, the time to reach upper
switching value from lower switching value), it is set automatically by the
S/N alarm low stroke time
following calculation result; (4000 ÷ BP flow rate setting value) [sec]
NOTE
 The setting of the time to the upper bound change point is not fixed
because it changes depending on the flow quantity of the blood pump
in consideration of patient's safety.
・It can be implemented the alarm setting about lower limit value of average
S/N stroke volume min
stroke volume during single needle.
・It is indicated average blood volume per 1 minute during single needle.
Effective blood flow
・The “-” also will be displayed at the time of S/N switch OFF.
・It is indicated average blood volume per 1 stroke in each 1 minute during
single needle.
・This value will be displayed “-” at the time of the followings because of
Average stroke volume
calculating; Starting single needle, setting change and 1st stroke from
returning an alarm.
・ The “-” also will be displayed at the time of S/N switch OFF.
4-4
4.3.3. To Start Single-Needle Click-Clack
№ Operation
1 Open the Single-Needle menu.
2 Set the target parameter and touch the OK button if you would like to change the parameter.
Visually check the setting value after you change the setting.
3 Turn on the Click-Clack button.
Refer to the following graph for the relationship between the blood pump operation and venous clamp
operation and venous pressure value at the single needle operation.
S/N_ON
ALARM SETTING
S/N PRESS.
HIGH CHANGE
POINT
Venous Pressure
S/N PRESS.
LOW CHANGE
POINT
ALARM SETTING
ON ON
BP
OFF OFF
Close Close
Open Open
CLV
NOTE
 The display of blood flow displays the set value regardless of movement or the stop of the blood pump.
Confirm AVERAGE BLOOD FLOW RATE in single needle window for average blood flow rate during
single needle operation.
 Contact your nearest branch or sales office for the procedure in order to check the recirculation of
blood flow.
4.3.4. To Stop Single-Needle Click-Clack
№ Operation
1 Open the Single-Needle menu.
2 Turn off the Click-Clack button.
4-5
4.4. SQUF Operation
4.4.1. SQUF Setting
SQUF is in medical treatment mode which performs fixed ultra filtration volume in regulation time.
In this medical treatment mode, since dialysis liquid does not flow into a dialyzer but only ultra filtration
operation is carried out, there is no diffusion by the clearance in a dialyzer.
If dialysis therapy is started where a setup of SQUF is carried out, SQUF will be performed immediately after
a start, Move to HD treatment after completion of SQUF treatment.
When performing SQUF during HD treatment, touching “SQUF” button on the upper tier moves to SQUF
treatment. Setting SQUF in UF profile also performs SQUF treatment as designed.
1 2 6 3 7 4
5 8
1. to 4. Ultra filtration setting for HD treatment

5. SQUF remaining time:
Time for SQUF is set up. It becomes a setup which became independent of Treatment time remaining.
6. SQUF rate:
Ultra filtration rate for SQUF is set up. It becomes a setup which became independent of UF rate
7. SQUF goal:
Target volume for SQUF is set up. It becomes a setup which became independent of UF goal.
8. SQUF vol.
Current volume for SQUF is displayed.
NOTE
 The maximum Ultra filtration rate at the time of SQUF can be set up by System Menu/ treatment/ UF.
 SQUF rate will be calculated automatically by changing SQUF goal.
 SQUF goal will be calculated automatically by changing SQUF rate.
4-6
5. Reinfusion
! WARNING
 Check blood leak frequency during dialysis because venous pressure sensor error is ±10mmHg
though limited sensitivity of the sensor is 1mmHg and the machine is provided with protective
system designed to minimize the error.
 Monitoring of the venous Pressure cannot always detect the disconnection of a venous needle from
its access site, which may result in extracorporeal blood loss to the environment. When a venous
needle disconnects from its access, pressure at the venous monitoring side may only decrease by
the pressure maintained within the patient’s access site. This pressure drop may be less than the
width of the machine’s venous pressure alarm window: in this particular case the disconnection of a
venous needle from its access site is not detectable by the machine, even if pressure alarms and
alarm windows are properly set.
 To reduce the risk of needles disconnection:
-Ensure that venous needle and line are firmly secured to the access site area according to your
clinic’s protocol.
-Ensure that the patient access is visible at all times during the dialysis treatment.
-Inspect frequently the patient’s access.
-Adjust properly the venous pressure alarm window: The venous pressure alarm lower limit
should be set as closely as practical to the actual patient’s venous pressure value without
generating excessive nuisance alarms.
 Venous pressure monitoring is not a reliable method of detecting a detached needle.
5.1. Reinfusion
5.1.1. Reinfusion achieving UF goal.

1. info : Treatment time reached display.
2. Press the Reset button.
3. Press the Reinfusion button. (Reinfusion window displays.).
5.1.2. Reinfusion aborting treatment.

1. Press the Reinfusion Button. (Reinfusion window displays.)
5-1
5.1.3. Reinfusion operation. (with no SPR option)
Starting of reinfusion
1. Connect the saline line to the saline bag.
2. Set a target reinfusion volume.
3. Set a blood pump flow.
NOTE
 The target reinfusion volume and the blood pump flow are automatically set to a default value each.
If necessary, change the target reinfusion value and blood pump flow.
4. Close the arterial line, using forceps.

5. Open the clamp of the saline line.
6. Turn on the “ Start” button in the reinfusion window, and rotate the blood pump to start reinfusion.
(The "Start" button will change to the "Stop" button.)
Suspending of reinfusion
1. Turn off the “ Stop” button during reinfusion.
(The “Stop” button will change to the “Start” button.)
2. To restart reinfusion, turn on the “Start” button.
Completion of reinfusion
1. The blood pump is stopped to complete the reinfusion process when the accumulated reinfusion
volume has reached the target reinfusion volume.
2. To continue the reinfusion process, increase the target reinfusion volume to set. Then turn on the
“Start” button.
3. Open the forceps of the arterial line for reinfusion of blood in the arterial line.
4. Close the arterial line when the blood reaches immediately before the patient.
5. Disconnect the blood line from the patient connector after completing reinfusion.
5-2
5.1.4. Reinfusion operation. (with SPR option)
To start reinfusion
1. Connect the saline line to the saline bag or substitution port.
2. Set the reinfusion volume.
3. Press the blood flow ON/OFF button.
NOTE
 The reinfusion volume and the blood flow are set to default value automatically. If necessary,
change the reinfusion value and blood pump flow.
4. Select the reinfusion mode from "Auto" or "Manual"

5. Select the "NaCl" or "Online" mode.
A. "Auto" mode
1. Turn on the "Start" button in the reinfusion window to start reinfusion. ( "Start" will be changed to
"Stop" button. )
B. "Manual" mode
1. Blood pump is stopped.
2. Turn on the "Start" button in the reinfusion window, blood pump will rotate to start reinfusion.
( "Start" will be changed to "Stop" button. )
! CAUTION
 Reinfusion of arterial line is also performed in “Auto” mode. It’s not performed in “Manual” mode.
Manual reinfusion is required.
Suspending of reinfusion
1. During reinfusion, turn off the "Stop" button.
( "Stop」will be changed to "Start" button. )
2. To resume reinfusion, turn on the "Start" button.
Completion of reinfusion
1. Blood pump is stopped to complete the reinfusion when accumulated reinfusion volume is
achieved target reinfusion volume.
2. Disconnect the blood line from patient connector after completing reinfusion.
5-3
5.2. Emptying the dialyzer
Drainage can be used by using automatic drainage or drainage function.
A. Automatic drainage (drainage of blood line and dialyzer.)

1. Press the "Drain" button in reinfusion window. (display the automatic drainage window.)
2. Release the connection of the arterial side, and make the venous side to be able to drain.
3. Remove the venous pressure line from the pressure port.(Not required on the machine with SPR
option)
4. Confirm the clamp of the saline line is closed. (Not required on the machine with SPR option)
5. Make the dialyzer venous port upper side.
6. Turn on the "Start" button in drainage window to start automatic drainage.
8. Remove the blue coupler from dialyzer and connect it to the coupler socket.
(Dialyzer is being emptied.)
9. Blood pump is stopped to complete the automatic drainage when accumulated drainage volume is
achieved target drainage volume.
10. Remove the red coupler from Dialyzer and connect it to the coupler socket.
11. Close the coupler flap.
B. Emptying the dialyzer.

1. Make the dialyzer venous port upper side.
2. Press the "Reinfusion" button to close reinfusion window. Then press the "Bypass" button.
3. Press the "Drain" button beside of "Bypass" button.
5. Remove the blue coupler from Dialyzer and connect it to the coupler socket.
(Dialyzer is being emptied.)
6. Remove the red coupler from Dialyzer and connect it to the coupler socket.
7. Close the coupler flap.
5.3. Emptying the B-cartridge. (Option)
B cartridge will be drained automatically when treatment complete.
! DANGER
* For contamination concern, dispose used blood circuit, dialyzer, and the air filter of the venous
pressure port in accordance with the disposal procedure for the Local regulations, hospital or
facility.
5.4. Completion of treatment mode
1. Press the "Cleaning" button.

2. Press the "Yes" button in guidance displayed, then move to cleaning standby mode.
5-4
6. Cleaning operation
Cleaning standby screen
Cleaning execution screen for Single cleaning (Rinse)
Cleaning execution screen for Program (Program 1-Rinse)
For detailed information regarding the screen refer to chapter 2
6-1
6.1. Setting of cleaning pattern
NOTE
 If no button is touched on the Cleaning standby, Cleaning execution or Cleaning complete
screen for a certain time (the time set as "Back light auto off time" in Basic) in the Cleaning mode,
the Message Display monitor turns off the back light to prevent the liquid crystal screen to be
burnt.
6.1.1. Cleaning solution setting
No. Action to be Taken
1 Press the System button.
2 Press the Setting button.
3 Press the Cleaning button.
4 Press either of the following buttons: Disinfection button, Decalcification button, Hot Disinfection button or Hot
Rinse button.
5 Press the button to be changed and change its settings.
! CAUTION
 Check original concentration and diluted concentration. If the setting is wrong, sufficient cleaning
effect may not be obtained.
 Sodium hypochlorite is recommended for the disinfection of the machine. Since some
microorganism may not be disinfected enough by the hot citric disinfection, perform disinfection
by sodium hypochlorite periodically.
 Be careful about temperature settings. The boiling point of pure water falls by 0.027°C as
atmospherical pressure falls by 1hPa. At the mountain top of 2000 meter from sea level,
atmospherical pressure falls by 200hPa and boiling point decreases to 94.6°C.
 After setting, check that the selected cleaning step is displayed on the Cleaning screen.
6-2
6.2. Check before the cleaning operation
The following basic requirements must be fulfilled before the start of a cleaning program:
(1) The dialyzer couplers are set firmly to the machine and the flap is closed.
(2) Nozzles for A concentrate and B concentrate are securely set in the corresponding nozzle
holders, and the cover flap is closed.
(3) The cartridge holder is completely closed
(4) Supply and drain is correctly connected
(5) For disinfection and decalcification, ensure that their original concentration and diluted
concentration are properly set at the Cleaning solution setting screen.
Any failure to comply with the basic requirements will be indicated by a message on the
display.
! CAUTION
 Input the same value as actual original concentration onto the Cleaning setting screen. The
corrosion resistance of the dialysate circuit is not guaranteed if settings are wrong.
 Set original concentration and diluted concentration within the range of the specification. The
corrosion resistance of the dialysate circuit is not guaranteed if settings are out of specification.
(Refer to chapter 11 Specification)
 The surfaces of exterior parts and silicone tubes become hot during the Hot Rinse and Hot
Disinfection operations. Keep highly flammable materials away from the hot surfaces.
 When using disinfectants, observe the manufacturer's instructions for use.
 When connecting the disinfectant container also observe the following criteria:
- The containers must be provided with a ventilation opening.
- The coding of the disinfection connectors.
- The disinfectant must match the respective disinfection program.
- Different disinfectants may not be mixed with each other.
 Prior to the use of disinfectants listed in Chapter 11
 "Consumables", make sure these are efficient and are compatible with the materials affected in
the hemodialysis system.
 Improper use of disinfectants (concentration, temperature range, dwell time) may cause damage
to the hemodialysis system.
 There is a possibility that the boiled water is coming out from the water supply port and the drain
port during IHR, removing the tubing, for example if the hose clamps are loosened.
NOTE
 Flow alarms during cleaning programs will increase the length of the cleaning program at least
by the time of the alarm.
 The count-down times shown during the cleaning programs are calculated values. This time may
vary depending on the ambient conditions.
6-3
6.3. Check during cleaning operation
! WARNING
 The surfaces of exterior parts and silicone tubes become hot during the Hot Rinse and Hot
Disinfection operations. Handle with care not to get burn injury.
 The inside of the dialysate circuit becomes very hot during the Hot Rinse and Hot Disinfection
operations. Do not operate with uncovered machine.
 Temperatures of solution may rise to nearly 100°C during the Hot Rinse and Hot Disinfection
operations. Do not touch spills when leakage is found. You may get burned.
6-4
6.4. Cleaning operation procedures
Automatic cleaning and single cleaning processes are described:

No. Action to be Taken
1 In case of single cleaning, select the cleaning step.

2 Press the Start button.
The Cleaning execution screen is displayed.
In case of automatic cleaning, the first step of the program starts.
In case of single cleaning, the selected cleaning step starts.
3 In case of automatic cleaning, the next step automatically starts when the predetermined time for each
cleaning step ends.
In case of single cleaning, the cleaning operation is complete.
4 In case of automatic cleaning, the Cleaning complete screen appears when all the predetermined steps
end.
NOTE
 The system cannot proceed into the Treatment mode during cleaning. Proceed after all cleaning
movements are complete.
 When the Heat Exchanger option is not installed, the Cool Down operation using water below
15°C may accelerate degradation of parts. Appropriate temperature management of supply
water is needed.
The weekly program and auto off function:
By pushing [Auto off 0 min]-key you can activate a function after

which the machine switch off disinfection completion.
By pushing the [Weekly program]-key the programmable

disinfection program will open.
6-5
In the following screen it is possible to activate per day two individual programs at a selectable time.
The plan is for the next 7 days.
When it is ON, the machine starts up at the preset time and the cleaning program is performed. Active
only when I/O powerkey is OFF.
Settings regarding disinfection under [System] [Settings] [Cleaning]:
6-6
6-7
6.5. Check after cleaning operation
After the cleaning operation, ensure that the system had a sufficient cleaning or disinfection and that
no solution (disinfectant) is remaining.
(After cleaning, check if solution (disinfectant) is remaining inside of the dialysate circuit using a test
paper or reagent.)
Sample can be taken at the blue coupler and the substitution port, using the test method
corresponding to the used disinfectant. If the test shows a residual concentration or in event of a
positive pH reaction (acid based disinfectants pH≤4.5), restart a cleaning program.
For peracetic acid based disinfectants use for example a potassium iodide starch paper
For sodium hypochlorite based disinfectants use for example a potassium iodide starch paper
For citric acid based disinfectants use for example determination of the pH
Observe the “use by” date of the indicator paper!
! DANGER
 If solution (disinfectant) remains inside of the dialysate circuit, it may cause a significant damage
to a patient. After cleaning with solution (disinfectant), clean thoroughly with water to ensure that
no solution (disinfectant) remains inside of the circuit.
 The inside of the dialysate circuit may be hot even after the operation of the Hot Rinse or Hot
Disinfection completes. Be careful not to get burned when opening covers.
! CAUTION
 It takes about 14 minutes at maximum to remove residual solution (disinfectant) completely by
cleaning with water. Clean the machine completely with water so that no residual solution
(disinfectant) exists.
 After the hot citric disinfection, it takes 9 minutes or more to remove residual citric acid. Clean
the machine completely with water long enough to wash off citric acid.
 In use of the central system (option), implement proper pathway cleaning between central port
to V45 and central port to V47 at the facility side.
NOTE
 Contact your nearest branch or sales office for the procedure in order to check the disinfection or
sterilization effect.
6-8
6.6. Clean up and disinfection
To maintain the performance of the machine for a long period of time, be sure to clean and disinfect
the machine after use and before storage.
NOTE
 When cleaning the screen, wipe it off while pressing any point other than buttons on the screen.
Buttons are protected not to operate while any other point is being pressed.
6.6.1. Cleaning and disinfecting of exterior

Be sure to clean and disinfect the exterior of the machine after use.
- Cleaning -
Wipe a stained part with dry and soft cloth.
When it is considerably stained, wipe the part with a squeezed cloth which is moisten with neutral
detergent weakened with water, and after that, remove moisture with a soft cloth.
- Disinfection -
When blood attached the machine, wipe it with disposable paper towel or cloth, after that, wipe with
water and then wipe it with sodium hypochlorite (1000ppm/0.1% dilution). And wipe the part with a
squeezed cloth which is moistened with water, and remove moisture with a soft cloth.
Do not use sodium hypochlorite concentrate directly.
! DANGER
 Do not mix sodium hypochlorite with acetic acid, citric acid or peracetic acid.
If mixed, it may produce chlorine gas harmful to human body.
Inhalation of the generated chlorine gas will cause serious danger to the human body.
 Perform a hot citric disinfection after every treatment.
! WARNING
 To avoid cross contamination among patients, clean and disinfect elaborately the venous or
arterial pressure port using cotton swabs etc.
! CAUTION
 Do not use organic solvents such as thinner, benzene, rubbing alcohol at the time of cleaning.
These chemicals damage the painted surface and plastics of the machine.
 Exercise caution so that no fluids enter into the venous or arterial pressure port. It can damage
the sensor.
 At the time of cleaning and disinfecting, be sure to use gloves and tools for protection.
6-9
6.6.2. Cleaning of Interior
Be sure to clean the interior of the unit after use.
(a) For soils in the interior of the dialysate circuit, wipe with a cloth damped with water.
(b) When dialysate, concentrate or other solutions adhere to the dialysate circuit, wipe it off immediately. It
can cause rust.
NOTE
 Turn off the I/O power key when cleaning the interior of the unit.
! WARNING
 Cleaning the electric circuit of the unit is extremely dangerous. No one other than the trained
professionals should open the electric circuit cover.
NOTE
 By using the following surface disinfectants we make the experience that several components
maybe damaged and the machine safety cannot guaranteed anymore. The manufacturer shall
no longer have any liability.
Known products at the moment: Inside extra©, Melsept©, Terralin©
 Do not open the substitute port, drain port, Dialyzer coupler bypass, cartridge holder,
Concentrate suction ports and not disconnect dialysis fluid filter when cleaning the surface. If this
instruction is not followed, a disinfection program must be performed after cleaning the surface.
6-10
6.6.3. Disinfection of hydraulic circuit
Be sure to disinfect the hydraulic circuit after use.
! WARNING
 Be sure to disinfect the hydraulic circuit after use. If not disinfected for a long period of time,
bacteria proliferate within the unit and they would enter patients through dialysis treatment.
Patients will be in life-threatening danger.
 Confirm that disinfectant is enough in the stock solution bottle before every disinfection. If the
bottle is empty during Disinfection mode, sufficient effect may not be obtained.
 Every disinfection, confirm by viewing that concentrate disinfectant must be supplied (aspirated)
into the unit completely.
 If a disinfectant is not supplied (aspirated) because of a damaged electromagnetic valve or other
reasons, it can cause cross contamination among patients.
 Confirm that residual disinfectant in the stock solution bottle is not increased after every
disinfection. If the disinfectant increased, sufficient disinfection might not be obtained.
NOTE
 The consumption of disinfectant is 38 mL, when the original concentration is 6% and the diluted
concentration is 0.1%. (With Online HDF option and B cartridge option model)
 The consumption of acid concentrate is 92 mL, when the original concentration is 50% and the
diluted concentration is 2%.
6.6.3.1. Recommended concentration of disinfectants
Use of sodium hypochlorite or hot citric acid is recommended for the disinfection of the
equipment.
Supply the equipment with disinfectant adjusted to the following concentration:
Sodium hypochlorite: 4 to 6 %
Citric acid: 10 to 50%
Check the descriptions on the container of the disinfectant and verify concentration, and
adjust it before using if needed.
! CAUTION
 Lower concentrations or dilution will result in insufficient disinfection.
6-11
6.6.3.2. Recommended diluted concentration and disinfection Time
The following disinfection condition is recommended :
Sodium hypochlorite: diluted concentration 1000ppm/0.1%, setting time 41 min or longer

Hot citric acid: diluted concentration 1.0%, setting time 39 min or longer
! WARNING
 If diluted concentration of disinfectant is lower than recommended value, or disinfection time is
less than the recommended time shown above, effective disinfection will not be achieved and
bacteria may proliferate within the unit. Patients will be in life-threatening danger.
6.6.3.3. Recommended disinfection type
The tepid disinfection and the hot citric disinfection are recommended.
The tepid disinfection is operable in the rage between 30 and 40°C. (35°C by default)
At the 35°C setting, disinfection is expected to complete with the dilution ratio and setting
time described in the previous page.
Hot citric disinfection temperature setting is fixed at 86 °C
! WARNING
 A temperature lower than 35 ℃ will result in insufficient disinfection and proliferation of bacteria
in the unit. Patients will be in life-threatening danger.
! CAUTION
 Since some microorganism may not be disinfected enough by the hot citric disinfection, perform
disinfection by sodium hypochlorite periodically.
 Contact the nearest sales branch or representative to ask about the effect of disinfection by
sodium hypochlorite and hot citric acid.
6.6.4. Removing calcium from the hydraulic circuit
Remove calcium from the hydraulic circuit by the decalcification of the cleaning process.
! WARNING
 When a bicarbonate dialysate is used, calcium carbonate precipitates inside of the unit. Calcium
carbonate precipitation makes it easier for bacteria to proliferate, which can then cause parts of
the unit to malfunction. Remove calcium at least once a week.
 While cleaning, check regularly if acetic acid is supplied / aspirated into the unit and calcium is
being removed. This should be checked approx. once a week. If acetic acid is not
supplied/aspirated because of a damaged electromagnetic valve or other reasons, calcium
cannot be removed.
6-12
7. Light indicator
7.1. Light indicator specifications 1
When "Information lamp pattern" setting of System-Setting-Basic is "1"
Red Not Light

Yellow Light
Green Blinking
Blue Fast Blinking
Rinse waiting Dialysis Preparation

Rinse Preparation Dialysis Retrans
Air Omission waiting complete
Alarm
Warning
Info.
Nurse call
Timer comp.
Bypass －－－－－－
Setting error
SW error －－
Priming comp.
HP infusion comp.
UF comp.
HP Stop －－－－－－
After HP infusion comp.

After UF comp. －－－－－－
SQUF －－－－
Normal
Upper rows are more prioritized.
7-1
7.2. Light indicator specifications 2
When "Information lamp pattern" setting of System-Setting-Basic is "2"
（＊２）
Upper rows are more prioritized.
*1) Detection HP infusion comp. : Yellow Blinking -> Mute : Yellow Lighting -> Alarm reset : Yellow not Lighting
Yellow not Lighting remains until detecting again
*2) Pre rinse waiting : Green not Lighting, Rinsing (except Pre rinse waiting) : Green Lighting
7-2
7.3. Description of terms
●Alarm
This condition lasts from the start of the alarm until the alarm is mute and reset.
●Nurse call
This condition indicates that the nurse call button is touched and notified, and lasts until it is mute.
●Timer complete
This condition indicates that the timer is complete. It lasts until the counter has stopped counting;
●Priming complete
This condition indicates that the priming process has been completed. The condition lasts until it is
reset.
●HP infusion complete

This condition indicates that heparin infusion is complete. The condition lasts until it is reset.
●UF complete
This condition indicates that UF is complete. It lasts until the buzzer is muted.
●After HP infusion complete

This condition indicates that heparin infusion is complete. It lasts from the moment the buzzer is
muted until the moment the system no longer detects alarming conditions.
●After UF complete
This condition indicates that UF is complete. It lasts from the moment the buzzer is muted until the
moment the system no longer detects alarming conditions.
● Setting error
This condition indicates that there is an error in a setting. The following is informed:
・No UF parameters programmed
・HP rate is not entered
・Filtration max. alarm. Please increase blood flow, or decrease UFR/Sub rate.
●SW error
This condition indicates that there is a SW error. The following is informed:
・UF stops. Please confirm UF condition.
・Bypass continues. Please confirm bypass condition.
・Press the treatment button.
●SQUF
This condition indicates that the SQUF treatment.
●Bypass operation
This condition indicates that the bypass is activated.
●UF STOP SW ON
This condition indicates that the UF STOP button is turned on.
●Normal operation
This condition indicates that the unit is in normal operation.
7-3
7.4. Escalation alarm system
When "Escalation alarm system" setting of System-Setting-Sound is "ON", the following lighting
patterns are replaced to the previous Alarm/Warning/Info light indicator specification.
7-4
8. Alarm operations and recovery
When abnormalities are detected, the system alerts the operator by the alarm lights, indicator light,
audible buzzers, and screen display of detailed alarm information. In addition, the safety system that
allows automatic emergency operation such as dialysis interruption is installed for some alarms.
! WARNING
 If alarm goes off repeatedly, turn off the unit promptly, interrupt dialysis, and separate the patient
from the unit. Continuous use can lead to severe hazard in the patient.
8.1. Description of alarms
8.1.1. Alarm messages
If some errors or abnormal conditions occur, the following three types of windows will appear to
notify the operator of the error or the abnormal condition.
Information (light blue window)

Warning (red window)
Alarm (red window)
NOTE
 Some alarms perform special alarm movements.
8.1.2. How to reset (recover)
To resume the normal unit operation after eliminating the cause of alarm emergence, perform the
following operations.
1 Press the Mute key.

· Audible alarm stops.
2 Eliminate the cause of alarm emergence.
3 Press the Reset key.
· The normal operation resumes.
8-1
8.1.3. Alarms and their main operations when errors are detected:
Alarm operation
Error
Buzzer Light indicator Main operation
When the arterial / venous pressure is Audible blinking in red Blood, Sub, and heparin pumps stop.
equal to or exceeds the UF operation stops.
maximum/minimum alarm set values Venous circuit is clamped.
When the dialysate pressure is equal to Audible blinking in red Sub pump stop.
or exceeds the maximum/minimum Bypass operation.
alarm settings UF operation stops.
When TMP exceeds the alarm set value Audible blinking in red Blood, Sub, and heparin pumps stop.
Bypass operation.
UF operation stops.
Venous circuit is clamped
Single bubble: Audible blinking in red Blood, Sub, and heparin pumps stop.
When 10 μL or larger is detected UF operation stops.
Micro bubble; Venous circuit is clamped.
Cumulated amount of 0.3 μL or larger
micro bubbles exceeds the set value for
the alarm.
When the dialysis fluid temperature is Audible blinking in red Sub pump stop.
lower than the minimum set value or Bypass operation.
higher than the maximum set value UF operation stops.
Heater OFF. (When the dialysis fluid
temperature is higher than the
maximum set value)
When volume of blood detected by the Audible blinking in red Blood, Sub, and heparin pumps stop.
blood leak detector is higher than a set Bypass operation.
value UF operation stops.
When the OVERLOAD DETECTION Audible blinking in red Heparin pump stops.
button of the heparin pump operates
(including injection completion)
When a unit-related error such as a Audible blinking in red The unit stops, etc.
temperature sensor error occur
When the measured conductivity of the Audible blinking in red Sub pump stops.
dialysate which enters the dialyzer is Bypass operation.
equal to or exceeds the maximum/ UF operation stops.
minimum alarm set values
8-2
Before Contacting Us
Check the following when errors are found in the unit. Contact nearest branch or agency if you
cannot figure out the causes or if the errors are not listed in the following table.
Error Cause Countermeasure
The cleaning standby The power cord is not connected to Connect the power cord to an outlet
screen does not appear an outlet properly. properly.
in spite of pressing the The power cord is disconnected. Check the outlet by connecting other
I/O power key. electric appliances. If the power cord is
disconnected, contact the agency where
you purchased the unit.
The key light is not lit in The battery for power failure backup Turn on the power breaker.
spite of pressing the I/O is low in charge and the power
power key. breaker is turned off.
Did not press the I/O power key for 3 Press the I/O power key for 3 consecutive
consecutive sec or longer. sec or longer.
Nothing or only a part of Backlight is turned off. Press the key on the operation panel.
a display appears on the
The connector to be connected to Connect the connector properly.
message display
the message display monitor is off.
monitor.
The dialysis temperature The water supply temperature is low. Set the water supply temperature properly
does not increase to the Refer to “11. Specification”.
setting temperature.
The dialysis temperature The water supply temperature is Set the water supply temperature at least
does not decrease to the high. the setting temperature of the unit – 5°C.
setting temperature.
The cleaning does not The system is in the Cleaning Select the rinse mode. Then touch the Start
start. standby process. button once.
The liquid stopped due to alarm Eliminate the cause(s) and reset the alarm.
emergence.
The blood pump does The blood pump cover is open. Close the blood pump cover firmly.
not rotate (when power is
The blood pump flow display is “0 Set the correct flow rate.
on or in case of power
mL/min”.
failure).
The blood pump stopped due to A blood circuit-related alarm is going off.
alarm emergence. Eliminate the cause(s) and reset the alarm.
The blood pump does The battery for power failure backup Charge the battery (energize the unit for 48
not rotate (in case of is low in charge. hours or longer).
power failure). The life of the battery for power Replace the battery.
failure backup expired.
8-3
The heparin pump does The heparin pump flow display is “0.0 Set the heparin pump follow as you
not rotate (when power mL/h”. desire.
is on or in case of The blood pump stopped. Move the blood pump.
power failure).
The heparin pump stopped due to Eliminate the cause(s) of overload.
overload.
The estimated heparin infusion time is Press the HP rate button if you need to
met. infuse again.
The system shows that the heparin pump Move the pusher to the right.
infusion is complete.
The heparin pump does The battery for power failure backup is Charge the battery (energize the unit for
not rotate (in case of low in charge. 48 hours or longer).
power failure). The life of the battery for power failure Replace the battery.
backup expired.
During the bicarbonate The concentration of concentrate is high. Use concentrate with a proper
dialysis, the actual concentration.
dialysate concentration The concentrate to be used and dialysate Correct the dialysate type setting.
is higher than the type setting are different.
setting concentration.
During the bicarbonate The concentration of concentrate is low. Use concentrate with a proper
dialysate concentration The concentrate is not aspirated Make the air to flow better by loosening
is lower than the setting sufficiently because the concentrate tank the cap for the concentrate tank, etc.
concentration. is closed.
The concentrate is not aspirated Straighten or unblock the silicone tube.
sufficiently because the silicone tube of
the concentrate line of the dialysate circuit
is bent or blocked.
The concentrate to be used and dialysate Correct the dialysate type setting.
type setting are different.
The concentrate connector is not Inset them properly.
inserted.
During the acetate The concentration of concentrate is high. Use concentrate with a proper
is higher than the type setting are different.
setting concentration.
8-4
During the acetate The concentration of concentrate is low. Use concentrate with a proper
is lower than the setting type setting are different.
concentration. The concentrate connector is not inserted. Inset them properly.
The actual dialysate Concentration adjustment has not been Adjust the concentration by proper
concentration does not done properly. procedures.
match the displayed Contact failure of the conductivity sensor Eliminate the cause of contact failure
concentration. harness. of the conductivity sensor harness.
Electrodes of the conductivity sensor are Remove rust or exchange the
rusty. electrodes.
Button operation does A button whose operation was not Some button operations do not work
not work. accepted by the system was touched. depending on a screen display or
process. Read the instruction manual
again before operation.
The connector on the PCB is off. Connect the connector properly.
A pressing point and the point the machine Start calibration of the touch panel on
recognized do not match. (Use the the System→Maker→Screen
cross-hair cursor displayed when it is calibration screen.
pressed.)
8-5
8.2. List of most common alarms
8.2.1. Conductivity
Alarm name: E027 Dialysate conductivity alarm
E101 Solution B conductivity alarm
Machine action: SFP stop, Bypass, UF stop
Possible cause: Conductivity exceeds the maximum set value for the alarm or falls below the
minimum set value.
Suggested steps Confirm that the actual concentration is within the set value.
to solve: Confirm that appropriate concentrate is used.
Confirm that no abnormality such as tube clogging is found in sensor or machine.
Press [alarm reset] - key to confirm the alarm
If no action help: Contact technical service for further assistance or repair
8.2.2. Venous pressure/ arterial pressure

Alarm name: E007 Venous pressure max alarm
E008 Venous pressure min alarm
E023 Arterial pressure max alarm
E024 Arterial pressure min alarm
Machine action: BP/SFP/HP stop, venous clamps close, UF stop
Possible cause: Venous pressure or arterial pressure exceeds the maximum set value for the
alarm or falls below the minimum set value.
Suggested steps Confirm that shunt section is not clogged or blood circuit is not bent.
to solve: Confirm that the blood pump circulates without problems.
8.2.3. TMP
Alarm name: E009 TMP alarm
Machine action: BP/SFP/HP stop, venous clamp close, Bypass
Possible cause: TMP exceeds the maximum set value for the alarm or falls below the minimum
set value.
Suggested steps Confirm that shunt section is not clogged or blood circuit is not bent.
to solve: Confirm that the blood pump circulates without problems.
Confirm that dialysate pressure is appropriate.
8-6
8.2.4. Temperature
Alarm name: E012 Dialysate temp max alarm
E013 Dialysate temp min alarm
Machine action: Bypass, UF stop, Heater OFF (When the dialysis fluid temperature is higher than
the maximum set value)
Possible cause: Dialysate temperature exceeds the maximum set value for the alarm or falls
below the minimum set value. (Dialysate Temp min alarm occurs if the alarm
condition continues for five (5) seconds.)
Suggested steps Confirm that the actual temperature is within the set value.
to solve: Confirm that feeding temperature is appropriate.
Confirm that no abnormality is found in sensor or heater.
Remark: Dialysate Temp min alarm is not detected for 60 seconds after resetting.
8.2.5. Air bubbles

Alarm name: E017 Air bubbles detected
Machine action: BP/SFP/HP stops, Venous clamp close, UF stop
Possible cause: Air bubbles are detected.
10 μL or larger single air bubble is detected.
Cumulated amount of 0.3 μL or larger micro bubbles exceeds the set value for
the alarm
Suggested steps Check for air bubbles in blood circuit.
to solve: Confirm that no abnormality is found in sensor.
Follow the instructions on the screen to solve the problem
8.2.6. UFP
Alarm name: E058 UFP error
Machine action: Stops
Possible cause: UF pump (UFP) rotation speed is significantly higher or slower than setting
value.
Suggested steps Confirm that no abnormality is found in UFP.
Alarm name: E061 UFP rotation error

Possible cause: UF pump (UFP) rotates backward.
8-7
Alarm name: E062 UFP speed error
Possible cause: UF pump (UFP) rotation speed is a little higher or slower than setting value.
Alarm name: E108 UFP stop error

Possible cause: UF pump (UFP) rotates even though it should be stopped.
8.2.7. Blood leak

Alarm name: E015 Blood leak alarm
Machine action: BP/SFP/HP stop, Bypass, UF stop
Possible cause: The blood leak value exceeds the blood leak alarm set value for five (5)
consecutive seconds.
Suggested steps Check for blood leak in the blood circuit.
to solve: Confirm that no abnormality is found in dialyzer.
Confirm that no abnormality is found in sensor.
8.2.8. Blood pump

Alarm name: E075 Blood pump error
Machine action: BP/SFP/HP stop, clamps close, UF stop
Possible cause: Blood pump rotation speed is significantly higher or slower than setting value.
Blood pump rotates backward.
Blood pump rotates even though it should be stopped.
Suggested steps Confirm that no abnormality is found in blood pump.
to solve:
8-8
8.3. Screen Failures
8.3.1. Operation on the screen impossible
When pressing the touch panel shows no reaction or dims the screen, execute reinfusion, using
normal saline solution, in the following procedure and immediately separate the equipment and the
patient.
*Stop the blood pump by rotate blood flow setting dial.

* Remove the puncture section on the arterial side from the patient to connect it to the normal saline
solution.
* Open the cover of the venous clamp box, while visually checking that no air bubbles enter the
venous side, and disconnect the tube from the venous side clamp.
("E018 Large bubbles detected" occurs but this alarm can be ignored.)
* Open the cover of the blood pump.
* Pull the lever forward and manually rotate the rotor in the clockwise direction while holding the
lever. Visually check that no air bubbles enter the venous line.
* Remove the puncture section on the venous side from the patient.
* Remove the blood line from blood pump.
8-9
8-10
9. Power failure backup
In case of power failure:

During treatment:
The dialysate flow and it is monitoring are stopped. The liquid crystal display, the touch panel,
the extracorporeal alarm system, the blood pump, the bubble detector for venous line, the
heparin pump, and the venous clamp are operated by the backup batteries for power failure.
During Start-up test, preparation, priming online, disinfection:
Display is active but actions are stopped. Priming with saline bag can continue.
Refer to the “Safety Precautions-13” and separate "Mending Manual" for the method in order to
check the charge state and replacement procedure of the backup batteries for power failure.
9.1. Power failure backup
9.1.1. Alarm operation in case of power failure
9.1.1.1. Power failure alarm buzzer
Buzzer sounds in case of power failure. Buzzer can be stopped by the Mute key.
9.1.1.2. Backup operation stop buzzer
When the remaining battery level is low at power failure operation, “Battery charge is low” is
detected and the buzzer sounds for a minute, and then the I/O power key is automatically
turned OFF. (The display gradually turns darker, and then the button and other items become
invalid.) The blood pump is stopped forcibly after detecting “Battery charge is low”.
Buzzer can be stopped by the Mute key.
NOTE
 The time between “Battery charge is low” detection and I/O power key is turn-OFF varies
depending on the equipment status and age of backup batteries.
9.1.1.3. Message at power failure
In case of power failure, ”Power failure” is displayed on the display. In this case, immediately
stop the ongoing treatment.
9-1
9.1.2. Blood pump operation in case of power failure
In case of power failure, the blood pump can be operated by the Blood pump I/O button, and
the blood pump flow setting dial.
When the Blood pump I/O button is ON in case of power failure, the blood pump operates at the set
rate, but can be adjusted. This set rat can set in System menu/ treatment/power failure.
When the Blood pump I/O button is OFF in case of power failure, the blood pump can be operated
by turning ON the Blood pump I/O button.
NOTE
 When the backup batteries for power failure are fully charged, the blood pump can operate for
approximately 30 minutes with the blood pump flow at 200mL/min and the heparin pump flow at
2mL/h. (factory setting )
 When the backup operation stop buzzer sounds, the blood pump automatically stops.
 The backup batteries for power failure are completely charged after approximately 48 hours
charge.
 Replace the backup batteries for power failure every 3 years.
9.1.3. Heparin pump operation in case of power failure
In case of power failure, the heparin pump can be operated by the Heparin pump I/O button and
the heparin pump flow setting button.
When the Heparin pump I/O button is ON in case of power failure, the heparin pump operates at
the rate before the power failure.
NOTE
 The heparin pump is operated only when the blood pump is operated.
 When the backup batteries for power failure are fully charged, the heparin pump can operate for
approximately 30 minutes with the blood pump flow at 200mL/min and the heparin pump flow at
2mL/h.
 The backup batteries for power failure are completely charged after approximately 48 hours
charge.
 Replace the backup batteries for power failure every 3 years.
9.1.4. Bubble detector for venous line operation in case of power failure
In case of power failure, in single air bubble mode air bubble with 10 μL or more (flow rate at
200mL/min, fluid temperature at 37 ± 1.0 °C) can be detected. In the Micro bubble mode, air
bubbles with 0.3 μL or more can be detected, and the alarm is triggered when the accumulated
bubble amount reaches the specified values (3 levels at 1/50/100μL).
! CAUTION
 Due to the voltage reduction of the backup batteries for power failure, the air bubble alarm may
be detected by mistake.
9-2
9.1.5. Pressure monitoring operation in case of power failure
When the dialysis process or the return process is in process in case of power failure, the
venous pressure, and arterial pressure are continuously monitored. When alarm is detected,
alarm operation is performed as before power failure.
9.1.6. Hydraulic line operation in case of power failure
All hydraulic lines stop in case of power failure.
9-3
9-4
10. Other functions
10.1. UF menu
1 2 3 4
5 6 7 8
No. Setting item Default Setting range Setting step Selection item
Value set at System - setting -
Treatment time
1 Treatment - UF - Initial treatment 0:00 – 23:59 0:01 -
remaining
time
2 UF goal 0.0 - 10.00 0.01 -
Treatment - UF - Initial UF goal
3 UF rate 0.0, 0.10 - 1.00 0.01 -
Treatment - UF - Initial UF rate
4 UF vol. 0.00 0.0 - 20.00 － -
SQUF time
5 --:-- 0:00 – 24:00 0:01 -
remaining
6 SQUF goal -.-- 0.00 – 10.00 0.01 -
7 SQUF rate -.-- 0.0,0.10 – 1.00 0.01 -
8 SQUF vol. -.-- 0.0 – 10.00 0.01 -
9 UF profile button OFF - - ON/OFF
10-1
10.2. Dialysate menu
1 2 3
5 6
4 7
11
8 9 10
AC1-2, Product name can
1 Dialysate BC4 -
BC1-10 be input.
Value set at System - Setting
2 Prescr. Na - Concentration - 125 - 160 1 -
Concentration information
3 Prescr. Bic - Concentration - 24 - 70 1 -
Value set at System - setting
- Treatment - Dialysate flow
4 Dialysate flow at the treatment start (HD) or 100 - 800 100 -
Dialysate flow at the
treatment start (ONLINE)
Concentration
5 OFF - - ON/OFF
profile button
Link with blood
6 OFF - - ON/OFF
flow button
7 Factor - Treatment - Dialysate flow 1.0 – 3.0 0.1 -
factor
8 Temp. - Treatment - Initial Dialysate 33.0 - 39.0 0.1 -
temperature
9 A supply source - Concentration - - - -
10 B supply source - Concentration - - - -
B-cartridge
11 OFF - - ON/OFF
change button
10-2
10.3. Subs. menu
3 1 4 5 2
10
7 8 9
Setting Setting Selection

No. Setting item Default
range step item
HD,
1 Treatment mode HD HDF predilution, HDF postdilution,
HF predilution, HF postdilution
2 Auto-sub button OFF - - ON/OFF
Value of set at System -
3 Sub goal setting - Treatment - ONLINE 1-720 1 -
- Initial Sub goal
4 Sub rate Treatment - ONLINE - Initial 10 - 500 1 -
rate
5 Sub volume 0.0 - - -
6 Sub pump button OFF - - ON/OFF
Sub Bolus one
7 Treatment - ONLINE - Sub 30-500 10 -
shot
bolus one shot
8 Sub Bolus rate Treatment - ONLINE - Sub 10-500 10 -
bolus one rate
9 Cum. bolus 0 - - -
10 Sub Bolus button OFF - - ON/OFF
10-3
10.4. SN menu ＜Click clack＞
1 Click clack button OFF - - ON/OFF
2 S/N press high change point 200 100-350 10 -
3 S/N press low change point 50 20-150 10 -
4 S/N alarm low stroke time 20 5-30 1 -
5 S/N stroke volume minimum 10 OFF,5-100 1 -
6 Effective blood flow rate 0 - - -
7 Average stroke volume 0 - - -
10-4
10.5. System screen
・ How to open System screen

Start up the machine.
Press the System button.
Select the type (Setting/Maintain/Maker).
The composition of each menu is as below:

Setting menu
User 1 Non 2 User 3
Alarm Basic Characteristics
User 4 User 5 Non 6

Cleaning Concentration First aid
User 7 User 8 User 9

Option Pressure Prep./Rein.
Setting menu
User 10 User 11
Sound Treatment
Maintain menu
User 1 Non 2 Non 3
Alarm overridden Data Dialysis graph
User 4 User 5 Non 6

Filling process Flowchart Machine history
User 7
Operating time
Maker menu
Maker 1 Maker 2 Maker 3
Software update Language update Parameter setting
Maker 4 User 5 Maker 6

Password Screen calibration Communication setting
Description on the upper left of each screen shows Administrator level. (Default)
Non: No password required. (for nurses)
User: User password required. (for engineers or doctors)
Maker: Maker password required. (for the manufacturer)
Pressing "Administrator level" button on the upper left enables changes.
10-5
10.5.1. Setting menu
- Alarm
Defaul Setting
Setting item Min. Max.
t step
1 UFRP change rate alarm % 100 10 100 1
2 Blood leak alarm ppm 300 50 500 10
3 Temperature alarm upper limit °C 39.0 37.0 40.0 0.1
4 Temperature alarm lower limit °C 34.0 29.0 36.0 0.1
5 Bubble detect setting (for Venous) μL 50 IND.10,1,50,100
6 Bubble detect setting (for Arterial) μL 50 IND.10,1,50,100
7 Conductivity alarm upper width % 5.0 2.0 9.9 0.1
8 Conductivity alarm lower width % -5.0 -9.9 -2.0 0.1
9 B-Conductivity alarm upper width % 5.0 2.0 9.9 0.1
10 B-Conductivity alarm lower width % -5.0 -9.9 -2.0 0.1
11 Zero UFR set notice - ON OFF/ON -
12 Zero HP rate set notice - ON ON/OFF -
13 Treatment button notice time min 15 1 60 1
14 Bypass button notice time min 5 OFF, 2 - 10 1
15 UF stop button notice time min 5 OFF, 2 - 10 1
16 First aid button notice time min 1 OFF, 1 - 10 1
17 BLD sensor error mask time min 5 OFF, 0.5-10.0 0.1
18 Pressure change of Art./PFI & Ven. mmHg 1 0 9 1
19 Pressure change time of Art./PFI & Ven. sec 20 10 60 1
20 Filtration limit for double needle. % 30 1 60 1
21 Filtration limit for single needle. % 30 1 30 1
22 Venous press alarm mask time After BP stop sec 10 1 20 1
23 Art./PFI press alarm mask time After BP stop sec 10 1 20 1
24 Pressure alarm lock time sec 30 20 120 1
- Basic
Setting
Setting item Default Min. Max.
step
1 Back light auto off time min 5 OFF, 1 -240 1
2 Screen saver activation time min 5 OFF, 1-60 1
3 Screen saver type - 1 1 2 1
4 Brightness % 100 5 100 1
5 Art./PFI pressure graph pattern - 1 1,2,3 -
6 V.pressure graph pattern - 1 1,2 -
7 TMP.graph pattern - 1 1,2 -
8 D.pressure graph pattern - 1 1,2 -
9 Cleaning auto off time - 0 0 30 1
10 Language - En -
11 Information lamp pattern - 1 1,2 -
10-6
- Characteristics
Setting
step
1 UFP flow mL 0.750 0.300 1.000 0.001
2 Year - 2000 2099 1
3 Month - - 1 12 1
4 Date - - 1 31 1
5 Time - - 00:00 23:59 1
6 V.press offset mmHg 0 -100 +100 1
7 Art./PFI press offset mmHg 0 -100 +100 1
8 D.press offset mmHg 0 -100 +100 1
9 UF offset mL/h 0 -99 +99 1
10 UF offset(CF) mL/h 0 -99 99 1
11 TMP offset - 0 0 100 1
12 BP mL/rev gain - 8.5 5.0 15.0 0.1
13 BP mL/rev offset - 0 -20 +100 1
14 SFP mL/rev gain - 5.7 5.0 15.0 0.1
15 SFP mL/rev offset - 0 -20 +100 1
16 BP Max flow mL/min 600 300 600 100
17 SFP Max flow mL/min 500 300 500 200
18 Memory back up - ON ON OFF -
19 Profile division number - 8 8,10,12
20 Closed circuit check during treatment min 60 OFF, 30-120 10
21 Blood sensor sensitivity (for Venous) V 2.0 0.0 5.0 0.1
22 Blood sensor sensitivity (for Arterial) V 2.0 0.0 5.0 0.1
23 Blood sensor detect time (for Venous) sec 2.0 0.0 20.0 0.1
24 Blood sensor detect time (for Arterial) sec 2.0 0.0 20.0 0.1
25 BP at blood sample mL/min 100 10 300 10
26 Blood countdown time sec 30 0 300 1
27 Closed circuit check during cleaning - OFF ON /OFF -
28 Time for rinsing of dialyzer after connecting coupler min 5 1 5 1
29 Fixed treatment time - ON ON OFF -
30 TMP offset recalculation at TMP alarm reset - OFF ON/OFF -
10-7
- Cleaning - Disinfection
Setting
step
Name of disinfectant1 - NaClO
Original conc. % 6.0 1 12 0.1
Diluted conc. % 0.1 0.01 0.20 0.01
Total time min 41 29 120 1
Dwell min 0 0 931 1
Post Rinse time min 14 14 60 1
Conductivity control mS/cm 0.2 0.1 15.0 0.1
Port No. - 1 1 2 1
Name of disinfectant2 - Peracetic acid
Diluted conc. % 0.04 0.01 0.20 0.01
Dwell min 0 0 931 1
Port No. - 1 1 2 1
Name of disinfectant3 - Disinf. 3
Diluted conc. % 0.03 0.01 0.20 0.01
Dwell min 0 0 931 1
Port No. - 1 1 2 1
Name of disinfectant4 - Disinf. 4
Diluted conc. % 0.03 0.01 0.20 0.01
Dwell min 0 0 931 1
Port No. - 1 1 2 1
10-8
- Cleaning - Decalcification
Setting
step
Name of disinfectant1 - Citric acid
Original conc. % 50.0 30.0 70.0 0.01
Diluted conc. % 1 1 5 1
Dwell min 0 0 931 1
Port No. - 2 1 2 1
Name of disinfectant2 - Acetate acid
Original conc. % 30.0 30.0 70.0 0.01
Dwell min 0 0 931 1
Port No. - 2 1 2 1
Name of disinfectant3 - Acid 3
Original conc. % 70.0 30.0 70.0 0.01
Dwell min 0 0 931 1
Post Rinse time Min 30 12 60 1
Port No. - 2 1 2 1
Name of disinfectant4 - Acid 4
Original conc. % 70.0 30.0 70.0 0.01
Dwell min 0 0 931 1
Port No. - 2 1 2 1
10-9
- Cleaning - Hot disinfection
Defaul Setting
t step
Name of disinfectant1 - Citric acid
Original conc. % 50.0 10.0 50.0 0.01
Diluted conc. % 1.00 0.1 2.0 0.1
T1 temp lower alarm °C 80 60 80 1
Port No. - 2 1 2 1
Name of disinfectant2 - Hot Disinf. 2
Original conc. % 20.0 10.0 50.0 0.01
Diluted conc. % 0.5 0.1 2.0 0.1
Port No. - 2 1 2 1
Original conc. % 20.0 10.0 50.0 0.01
Diluted conc. % 0.5 0.1 2.0 0.1
Port No. - 2 1 2 1
Original conc. % 20.0 10.0 50.0 0.01
Diluted conc. % 0.5 0.1 2.0 0.1
Port No. - 2 1 2 1
- Cleaning - Rinse/Hot rinse/IHR

Defaul Setting
t step
T1 temp. lower alarm °C 80 60 80 1
Hot rinse total time min 39 39 60 1
Rinse total time min 10 5 120 1
IHR total time min 30 30 200 1
10-10
- Cleaning - General
Defaul Setting
t step
Mandatory disinfection between Treatment - OFF ON/OFF -
IHR including hydraulic part. - YES YES/NO -
Disinfectant conductivity control - OFF ON/OFF -
Mandatory disinfection after CF change - OFF ON/OFF -
Temp. for disinfection / decalcification °C 35 OFF, 30-40 1
control T2 temp. for Hot dis./ Hot Rinse °C 96 - -
- Cleaning - Cleaning standby

Setting
step
Program1 Not available Available , Not Available
Rinse Available Available , Not Available
Disinfection Available Available , Not Available
Decalcification Available Available , Not Available
Hot disinfection Available Available , Not Available
Hot rinse Available Available , Not Available
IHR Not available Available , Not Available
10-11
- Concentration - Concentration information
Setting
step
Concentrate Type - BC4 - - -
Na conc. of A mmol/L 110
Na conc. of B mmol/L 30 24 70 1
HCO3 conc. of B mmol/L 30 24 70 1
Prescribed Na mmol/L 140 125 165 1
Available range of Na concentration of B (From) mmol/L 24 24 70 1
Available range of Na concentration of B (to) mmol/L 70 24 70 1
Available range of Na concentration of total (From) mmol/L 125 125 165 1
Available range of Na concentration of total (to) mmol/L 165 140 165 1
A supply souce Front pipe - Front pipe, Central A1, Central A2
B supply souce Front pipe - Front pipe, Central B1, B-cartridge
W+A Ratio - 35.00 32.26 52.26 0.01
W+B Ratio - 27.78 17.55 70.70 0.01
Mix Ratio(B) - 1.26 0.50 2.00 0.01
Mix Ratio(W) - 32.74 30.00 50.00 0.01
P3 one revolution volume mL/rev 0.300 0.200 0.400 0.001
P4 one revolution volume mL/rev 0.300 0.200 0.400 0.001
Chamber A Volume mL 100 95.0 105.0 0.1
W+A offset - 0 -10.0 10.0 0.5
W+A+B offset - 0 -10.0 10.0 0.5
Chamber B Volume mL 100 95.0 105.0 0.1
W+A offset - 0 -10.0 10.0 0.5
W+A+B offset - 0 -10.0 10.0 0.5
- First aid
Setting
step
1 First aid function - ON ON/OFF -
2 UFR L/hr 0.00 0.00,0.10
3 Dialysate flow bypass - YES Yes/No -
4 Substitution pump stop - YES Yes/No -
5 Blood pump flow mL/min 100 0 100 10
6 Blood pressure measurement - YES Yes/No -
7 Interval min OFF OFF,5,10,15,30,45,60
8 Quick I/O - OFF ON/OFF
10-12
- Option
Setting
step
1 BPM - OFF ON/OFF -
2 CF1 - OFF ON/OFF -
3 B powder - OFF ON/OFF -
4 Central system(A1,A2) - OFF ON/OFF -
5 Central system(A1,B1) - OFF ON/OFF -
6 SPR - OFF ON/OFF -
7 External Network - OFF ON/OFF -
8 ONLINE HDF - OFF ON/OFF -
9 Drain port - OFF ON/OFF -
10 IC Card - OFF ON/OFF -
11 Voltage V 230 110V/230V -
12 IHR - OFF ON/OFF -
10-13
- Pressure - Venous
Setting
step
1.Fixed alarm point upper limit
mmHg 300 40 480 10
-HD, SQUF, On-Line HDF, On-Line HF
mmHg 400 40 480 10
-SN click-clack
2.Auto.set.alarm point upper width
mmHg 70 20 200 10
-HD
mmHg 70 20 200 10
-SQUF
mmHg 70 20 200 10
-On-Line HDF
mmHg 70 20 200 10
-On-Line HF
3.Auto.set.alarm point lower width
mmHg -20 -200 -10 10
-HD
mmHg -20 -200 -10 10
-SQUF
mmHg -20 -200 -10 10
-On-Line HDF
mmHg -20 -200 -10 10
-On-Line HF
4.Fixed alarm point lower limit
mmHg -10 -100 440 10
mmHg 10 -100 440 10
-SN click-clack
5.Con/Rein alarm point lower limit
-HD, SQUF, On-Line HDF, On-Line HF mmHg -100 -50 300 10
*Con/Rein: Patient connect/Reinfusion
5.Con/Rein alarm point lower limit
-SN click-clack mmHg -100 -50 300 10
*Con/Rein: Patient connect/Reinfusion
10-14
- Pressure - Art./PFI
Setting
step
mmHg 480 10 480 10
mmHg 480 10 480 10
-SN click-clack
mmHg 70 20 200 10
-HD
mmHg 70 20 200 10
-SQUF
mmHg 70 20 200 10
-On-Line HDF
mmHg 70 20 200 10
-On-Line HF
mmHg -70 -200 0 10
-HD
mmHg -70 -200 0 10
-SQUF
mmHg -70 -200 0 10
-On-Line HDF
mmHg -70 -200 0 10
-On-Line HF
mmHg -250 -480 480 10
mmHg -250 -480 480 10
-SN click-clack
10-15
- Pressure - Dialysate
Setting
step
mmHg 400 0 640 10
mmHg 400 0 640 10
-SN click-clack
mmHg 100 20 400 10
-HD
mmHg 100 20 400 10
-SQUF
mmHg 100 20 400 10
-On-Line HDF
mmHg 100 20 400 10
-On-Line HF
mmHg 100 20 400 10
-SN click-clack
mmHg -100 -400 -20 10
-HD
mmHg -100 -400 -20 10
-SQUF
mmHg -100 -400 -20 10
-On-Line HDF
mmHg -100 -400 -20 10
-On-Line HF
mmHg -100 -400 -20 10
-SN click-clack
mmHg -400 -640 -40 10
mmHg -400 -640 -40 10
-SN click-clack
10-16
- Pressure - TMP
Setting
step
mmHg 500 0 700 10
mmHg 500 0 700 10
-SN click-clack
mmHg 20 20 500 10
-HD
mmHg 50 20 500 10
-SQUF
mmHg 50 20 500 10
-On-Line HDF
mmHg 50 20 500 10
-On-Line HF
mmHg 50 20 500 10
-SN click-clack
mmHg -20 -300 20 10
-HD
mmHg -50 -300 20 10
-SQUF
mmHg -50 -300 20 10
-On-Line HDF
mmHg -50 -300 20 10
-On-Line HF
mmHg -50 -300 20 10
-SN click-clack
mmHg -30 -200 200 10
mmHg -30 -200 200 10
-SN click-clack
- Pressure - Others
Setting
step
1 Ven. auto set alarm point upper width (Con.) mmHg 100 20 200 10
2 Ven. auto set alarm point lower width (Con.) mmHg -100 -200 -20 10
3 Ven. auto set alarm point upper width (Rein.) mmHg 100 20 200 10
4 Ven. auto set alarm point lower width (Rein.) mmHg -100 -200 -20 10
5 Art./PFI auto set alarm point upper width (Con.) mmHg 100 20 200 10
6 Art./PFI auto set alarm point lower width (Con.) mmHg -100 -200 -20 10
7 Art./PFI auto set alarm point upper width (Rein.) mmHg 100 20 200 10
8 Art./PFI auto set alarm point lower width (Rein.) mmHg -100 -200 -20 10
*Con.: Patient connect
*Rein.: Reinfusion
10-17
- Prep./Rein.
Setting
step
1 SPR function - ON ON ON ON ON/OFF -
2 Selection of blood tubing set - 1 2 3 4 1 4 1
3 Displayed name of Filter inlet pressure - Art Art Art Art Art. or PFI -
4 Rinse volume initial setting mL 1000 1000 1000 1000 500 3000 100
5 Priming rate initial setting mL/min 100 100 100 100 10 200 10
6 Reinfusion volume initial setting mL 300 300 300 300 50 500 10
7 Reinfusion rate initial setting mL/min 100 100 100 100 10 200 10
8 Max BP flow in reinfusion mL/min 200 200 200 200 10 200 10
9 Alarm width fix time in reinfusion sec 120 120 120 120 10 120 1
10 Drain port use. - OFF OFF ON ON ON/OFF -
11 BP stop at blood detected. - ON ON ON ON ON/OFF -
12 Blood flow at Patient connect mL/min 100 100 100 100 10 300 10
13 checking for connecting blood line - OFF OFF OFF OFF ON/OFF -
14 detection rise for blood line mmHg 50 50 50 50 5 300 1
15 detection rise for blood line sec 20 20 20 20 5 95 1
16 detection leak for blood line mmHg 10 10 10 10 5 300 1
17 detection leak for blood line sec 5 5 5 5 5 95 1
18 first checking for empty saline sec 9 9 9 9 OFF,1-30 1
19 priming volume for wet dialyzer mL 0 0 0 0 0 99 1
20 primary priming volume for saline line mL 20 20 0 0 0 99 1
21 level adjustment for saline chamber mL 8 8 0 0 0 99 1
22 level adjustment for Art./PFI chamber mL 18 25 25 35 0 99 1
23 priming volume for heparin line - OFF OFF OFF OFF OFF,0.5-9.9 0.1
24 target priming volume for venous line mL 500 500 500 500 0 9999 1
25 level adjustment for venous chamber mL 20 15 15 15 0 99 1
26 BP flow for venous priming mL 200 200 200 200 10 500 5
27 target priming volume for arterial line mL 50 50 50 50 10 999 1
28 one cycle volume for arterial priming mL 4 4 4 4 2 9 1
29 BP flow for quick rinsing mL 300 300 300 300 10 500 5
30 CLV open time for quick rinsing sec 5 5 5 5 1 10 1
31 CLV close time for quick rinsing sec 2 2 2 2 0 10 1
32 automatic transition to circulation - OFF OFF OFF OFF ON/OFF -
33 BP flow for circulation mL/min 300 300 300 300 10 500 5
34 ignore time for saline sensor detection sec 10 10 10 10 0 30 1
35 automatic off for HP (reinfusion) - ON ON ON ON ON/OFF -
36 BP flow for reinfusion mL/min 100 100 100 100 OFF,30-600 10
37 primary priming volume (reinfusion) mL 100 100 100 100 30 100 10
38 primary priming CLS open time (reinfusion) sec 1 1 1 1 1 10 1
39 primary priming CLS close time (reinfusion) sec 1 1 1 1 0 10 1
40 one cycle volume for arterial reinfusion mL 4 4 4 4 2 4 1
41 reinfusion volume for arterial mL 30 30 30 30 10 99 1
42 reinfusion volume for venous mL 270 270 270 270 100 500 1
43 delay time for saline sensor detection sec 4.0 4.0 4.0 4.0 0.4 30.0 0.1
bubble removal function for arterial during
44 mL 30 30 30 30 OFF,1-50 1
automatic reinfusion
bubble removal function for arterial except
45 mL 10 10 10 10 OFF,1-50 1
during automatic reinfusion
10-18
Setting
step
46 drainage control pressure high range mmHg 200 200 200 200 0 300 10
47 drainage control pressure low range mmHg -400 -400 -400 -400 -400 0 10
48 Max BP flow for drainage of blood line mL/min 200 200 200 200 100 600 10
49 Reinfusion stop at blood not detected (Ven) - OFF OFF OFF OFF ON/OFF
50 ART bubble sensor mask function at CTS mL 40 40 40 40 0 300 1
51 Priming volume of substitution line mL 0 0 25 25 0 200 1
52 Rinse volume of substitution line mL 0 0 25 25 0 999 1
53 Clean-Treatment-Start - ON ON ON ON ON/OFF
54 Drain speed for CTS mL/min 100 100 100 100 30 150 10
55 Arterial blood line volume for CTS mL 120 120 120 120 0 1000 10
56 Venous blood line volume for CTS mL 150 150 150 150 0 1000 10
57 CTS stop dialysate-pressure mmHg -200 -200 -200 -200 -400 0 10
58 BP flow for drainage of blood line mL/min 200 200 200 200 100 600 10
- Sound
Setting
step
1 Sound volume - 3 1 5 1
2 I/O (Power) on - 1 OFF,1 -
3 Alarm - 2 1 3 1
4 Warning - 2 OFF,1,2 1
5 Info - 1 OFF,1,2 1
6 Rinse volume reached - 1 OFF,1 - 6 * 1
7 UF Goal reached - 4 OFF,1 - 6 * 1
8 SQUFG reached - 5 OFF,1 - 6 * 1
9 Reinfusion volume reached - OFF OFF,1 - 6 * 1
10 Cleaning complete - 1 OFF,1 - 6 * 1
11 Auto power off - 2 OFF,1,2 1
12 Silent mode click sound - OFF ON/OFF -
13 arterial reinfusion goal melody - 2 OFF,1 - 6 * 1
14 UF goal melody sounds time sec 5 OFF,5 - 120 5
15 arterial reinfusion goal melody sounds time sec 5 OFF,5 - 120 5
16 reinfusion goal melody sounds time sec 5 OFF,5 - 120 5
17 Escalation alarm system - OFF ON/OFF -
*Sound files
1 Sound 1
2 Green sleeves
3 Ode to Joy
4 Twinkle, Little Star
5 Kanon
6 Sound 2
10-19
- Treatment - UF
Setting
step
1 Initial treatment time - 4:00 00:00 24:00 1
2 Initial UF goal L 0.0 0.0 10.0 0.1
3 Initial UF rate L/H 0.00 0.01 1.00 0.01
4 UFR MAX(General) L/H 1.0 0.1 5.0 0.1
5 UFR MAX(SQUF&Profile) L/H 1.0 0.1 5.0 0.1
6 UFR increasing notice rate % 1 1 30 1
7 Sub goal decreasing notice rate % 1 1 30 1
8 Treatment shortening time min 1 1 30 1
9 Prior UF parameter during treatment - UF time UF time/UF goal -
- Treatment - Dialysate
Setting
step
1 Initial Dialysate temperature °C 36.5 33.0 39.0 0.1
2 Dialysate flow at the treatment start(HD) mL/min 500 100 800 100
3 Dialysate flow at the treatment start(ONLINE) mL/min 500 100 500 100
4 Dialysate flow factor - 1.5 1.0 2.0 0.1
5 Dialysate temperature offset(T3) °C 0.0 -2.0 2.0 0.1
- Treatment - Subs.
Setting
step
1 Initial Sub goal L 12 1 600 1
2 Initial Sub rate mL/min 50 10 500 1
3 Initial Auto sub setting - OFF ON/OFF -
4 Auto-sub rate limit(pre) % 50 5 200 1
5 Auto-sub rate limit(post) % 20 5 50 1
6 Sub bolus one shot mL 100 30 500 10
7 Sub bolus rate mL/h 100 10 500 10
8 Sub rate limitation with BP(post) % 30 5 33 1
9 BP at bypass in HDF/HF post dilution mL/min 100 10 200 5
10 Substitution time upper limit min 2 2 50 1
11 BP rate resume time after substitution sec 60 OFF,0-300 1
12 Blood detector activating volume after substitution mL 200 OFF,10-1000 10
- Treatment - Heparin
Setting
step
1 HP flow rate mL/h 2.0 0.1 10.0 0.1
2 Nipro syringe size mL 20 OFF,10,20,30 -
3 Syringe ratio % 100 50-200 1
4 HP bolus one shot mL 0.0 0.0 5.0 0.1
5 Automatically use of heparin - OFF ON/OFF -
6 Automatic bolus - OFF OFF,PC,BD -
7 Heparin stop time selection - Remaining Remaining/Elapsed -
8 Heparin stop time h:min OFF OFF,0:01-24:00 0:01
- Treatment - Power failure

Setting
step
1 BP flow in power failure mL/min 100 30 300 10
10-20
10.5.2. Maintenance menu
The following values that are mentioned here could be changed without notes.
- Alarm overridden
Setting
step
1 Air bubble OFF ON /OFF -
2 Temperature OFF ON /OFF -
3 Blood leak OFF ON /OFF -
4 Venous pressure OFF ON /OFF -
5 Dialysate pressure/TMP OFF ON /OFF -
6 Art./PFI pressure OFF ON /OFF -
7 System(All) OFF ON /OFF -
8 System(TMP offset) OFF ON /OFF -
9 System(UFRP change rate) OFF ON /OFF -
10 System(Heater over heat) OFF ON /OFF -
11 System(Art./PFI pressure limit) OFF ON /OFF -
12 System(Venous pressure limit) OFF ON /OFF -
13 System(Dialysate pressure limit) OFF ON /OFF -
14 System(T1 sensor) OFF ON /OFF -
21 System(Hp drive error(PH7)) OFF ON /OFF -
22 System(Hp drive error(PH8)) OFF ON /OFF -
23 System(Water supply sensor) OFF ON /OFF -
24 System(AS2) OFF ON /OFF -
25 System(CLA position) OFF ON /OFF -
26 System(CLV position) OFF ON /OFF -
27 System(Syringe not detected) OFF ON /OFF -
28 System(CLS position) OFF ON /OFF -
10-21
- Data - Pressure
Setting
step
1 PV mmHg Only displayed - - -
2 PA mmHg Only displayed - - -
3 PD mmHg Only displayed - - -
4 TMP mmHg Only displayed - - -
5 UF.COEFF - Only displayed - - -
6 UFRP CHANGE RATE % Only displayed - - -
7 TMP OFFSET mmHg Only displayed - - -
- Data - Temperature Conductivity

Setting
step
1 T1 °C Only displayed - - -
8 CD1 mS/cm Only displayed - - -
- Data - B.T.V
Setting
step
1 TREATED BLOOD TIME min Only displayed - - -
2 TREATED BLOOD VOLUME L Only displayed - - -
3 (DIALYSATE) L Only displayed - - -
4 (REINFUSION) L Only displayed - - -
5 (SQUF) L Only displayed - - -
6 (BYPASS) L Only displayed - - -
7 CUM HEPARIN VOLUME mL Only displayed - - -
- Data - BLD
Setting
step
1 BLD VALUE ppm Only displayed - - -
2 BLD AUTO ZERO ppm Only displayed - - -
3 BLD REAL VALUE ppm Only displayed - - -
4 DUMMY BLD VALUE ppm Only displayed - - -
10-22
- Operating time
Setting item Default Min. Max. Setting step
1 POWER hours 0 - - -
2 V1DIAPH times 1000 0 30000 1
3 V4DIAPH times 1000 0 30000 1
4 V5aDIAPH times 1000 0 30000 1
5 V5bDIAPH times 1000 0 30000 1
6 V6aDIAPH times 1000 0 30000 1
7 V6bDIAPH times 1000 0 30000 1
8 V7aDIAPH times 1000 0 30000 1
9 V7bDIAPH times 1000 0 30000 1
10 V8aDIAPH times 1000 0 30000 1
11 V8bDIAPH times 1000 0 30000 1
12 V9aDIAPH times 1000 0 30000 1
13 V9bDIAPH times 1000 0 30000 1
14 V10DIAPH times 1000 0 30000 1
15 V11DIAPH times 1000 0 30000 1
16 V12DIAPH times 1000 0 30000 1
17 V17DIAPH times 1000 0 30000 1
18 V19DIAPH times 1000 0 30000 1
19 V21DIAPH times 1000 0 30000 1
20 V23DIAPH times 1000 0 30000 1
21 V24DIAPH times 1000 0 30000 1
22 V27DIAPH times 1000 0 30000 1
23 V28DIAPH times 1000 0 30000 1
24 V29DIAPH times 1000 0 30000 1
25 V30DIAPH times 1000 0 30000 1
26 V31DIAPH times 1000 0 30000 1
27 V33DIAPH times 1000 0 30000 1
28 V34DIAPH times 1000 0 30000 1
29 V35DIAPH times 1000 0 30000 1
30 V36a(Op)DIAPH times 1000 0 30000 1
31 V36b(Op)DIAPH times 1000 0 30000 1
32 V36c(Op)DIAPH times 1000 0 30000 1
33 V43DIAPH times 1000 0 30000 1
34 V44DIAPH times 1000 0 30000 1
35 V45DIAPH times 1000 0 30000 1
36 V46DIAPH times 1000 0 30000 1
37 V47DIAPH times 1000 0 30000 1
38 V48DIAPH times 1000 0 30000 1
39 V51DIAPH times 1000 0 30000 1
40 V52DIAPH times 1000 0 30000 1
41 AS2 O-RING hours 17000 0 30000 1
42 FILTER hours 8500 0 30000 1
43 CF1(Op) hours 1200 0 30000 1
44 CF2(Op) hours 1200 0 30000 1
10-23
10.5.3. Maker menu
Setting items for manufacturer
10-24
10.6. Function screen
・ How to open Function menu screen

Start up the machine.
Press the System button.
Select the function.
The composition of each menu is as below:
Function menu
1 2 3
BPM Dose finder Timer
4 5
Patient information Patient setting change
7
Sampling
10.6.1. BPM
Refer to “13. Blood pressure monitor" for details.
10-25
10.6.2. Dose finder
! CAUTION
 The Dose-Finder attempted to predict the Kt / V of a therapy. The value cannot be used for the
therapy adjustment. It is a not measured only a calculated value. The predicted Kt / V of the
Dose-Finder and the actual Kt / V can differ from each other.
- Kt/V setting
1 2 3
4 5 6 7 8
9 10 11
Setting
No. Setting item Default Setting range
step
System - setting - Treatment –
1 Treatment time remaining 0:00 – 24:00 1
UF - Initial treatment time
2 Blood flow 200 10 - 600 5
OFF,
3 Blood sample time OFF 0:01
00:01 - 24:00
4 Patient information 1 1-8 1
5 Sex Male Male - Female -
6 Height 175 50 - 250 1
7 Weight 80 20 - 300 1
8 Age 50 1 - 120 1
9 Target Kt/V 1.2 0.5 - 2.0 0.1
10 Current Kt/V - - 0.1
11 Estimated Kt/V - - 0.1
10-26
- Kt/V graph
4, 5
6 7 8
1 Vertical axis：Kt/V - - - -
2 Target Kt/V horizontal line - - - -
3 Horizontal axis：Time - - - -
4 Estimated Kt/V graph（dotted line） - - - -
5 Current Kt/V graph（solid line） - - - -
6 Target Kt/V - 0.0 - 2.0 0.1 -
7 Estimated Kt/V - - - -
8 Current Kt/V - - - -
ＮＯＴＥ
 After treatment begins, the graph is not plotted for less than five minutes.
 The update of the display is assumed to be timing to which the except treatment time remaining
is updated. Therefore, the display is not updated while the UF is stopping.
 SQUF execution time is not included at the treatment time.
10-27
10.6.3. Timer
2
1
3
4
1 Remaining time 00:00:00 00:00:00 - 99:59:59 - -
2 Start - - - -
3 Stop - - - -
4 Reset - - - -
5 Melody 2 1-6 - -
10.6.4. Patient information / Patient setting change
Refer to “14. Card system (Option)" for details.
10-28
10.6.5. Sampling
1 2
1 Sampling time dialysate 60 1 - 600 1 -
2 Sampling button OFF - - ON/OFF
3 Remaining time 0 - - -
10-29
10.7. First aid button
NOTE
 Press the first aid button for 3 seconds to execute a function set on the System - Setting - First
aid screen.
 This button is valid only during the dialysis process.
 Turning [First air function] to OFF on the System-Setting-First aid screen invalidates this function
and disables the First aid button.
10.7.1. Setting of First aid button

Operation to be executed while the first aid function is valid can be set on the System-Setting-First
aid screen.
The first aid function itself can be set on the System-Setting-First aid screen.
10.7.2. Execution of First aid button
Press the First aid button for more than 3 seconds during the dialysis process.
The light indicator lights up in yellow.
Operation set on the System-Setting-First-aid screen is executed.
10.7.3. Resetting of First aid button function
* The UF speed has been changed.

* The blood pump flow has been changed.
* The bypass operation is reset.
* The First aid button has been turned to OFF.
10-30
10.8. Emergency saline infusion
This function supplies saline in emergency if the patient's blood pressure drops.
Turning ON the Bolus button under the following condition starts one-shot operation.
* SPR option is ON.

* Treatment mode.
* Blood pump is not stopped.
One-shot operation clamps the arterial side clamp and infuses

saline by the blood pump. The blood pump flow follows the Sub
bolus rate.
After completion of one-shot operation or discontinuation, the flow
returns to the blood pump flow before one-shot operation after
elapse of set time of "BP rate resume time after substitution" of
“System – Setting – Treatment – Subs.”. If this setting is OFF, the flow during one-shot operation is
maintained even after completion or discontinuation.
During one-shot operation, the cumulated volume of infusion to the cum. bolus section is displayed.
After this operation is finished, the total infusion volume achieved during this treatment is displayed.
Turning OFF the bolus button during one-shot operation stops the operation forcibly to change to
the normal substitution fluid operation.
! WARNING
 Blood flow stops during emergency saline infusion. Keep monitoring the patient’s condition
during infusion because it expands the range of pressure monitoring. .
 When executing one-shot operation, control the patient weight while checking the total bolus
volume each time.
10-31
10.9. Changing the CF
! CAUTION
 Use the specified CF only.
 When using CF, follow the instructions below related to the hygiene.
 Do not use CF if the package is damaged.
 Open the package and remove protective caps just before use.
 Touch CF if necessary but by connector only.
NOTE
 Time for replacement is displayed on the Cleaning screen.
 Message about filter replacement is displayed when the cleaning program is selected.
10.9.1. Filter Replacement Rule
・ Filter is defective. (A leak was found in the leak check test.)

・ At the end of filter life time (Refer to below)
-When Peracetic acid is used.

200 treatments / approx. 1200 hrs.
30 Sodium-hypochlorite disinfections are possible in a life cycle of CF-609N.
-When Citric acid is used.

300 treatments / approx. 1800 hrs
30 Sodium-hypochlorite disinfections are possible in a life cycle of CF-609N.
10.9.2. Filter Replacement
! CAUTION
 Follow the filter replacement procedure.
№ Operation
1 The machine must be disconnected from a patient.
2 Go to the Cleaning screen and touch the Filter change button.
3 Replace the filter according to the guidance displayed on the screen.
! CAUTION
 Disinfect the machine after the filter replacement.
10-32
10.10. Changing the Dialyzer or the Blood Tubing Set
! CAUTION
 Perform reinfusion before starting the exchange function if possible. Never return to reinfusion
again after starting the exchange procedure.
No. Operation
1 Press the Dia/BTS Exchange button for more than 1 second after completion of reinfusion.
2 Press the Bypass button according to the guidance displayed on the screen.
3 Remove parts which need replacement after draining the dialyzer by pressing the Drain button.
Replace the coupler to the machine, close the flap and return to the preparation complete process.
4 Resume the priming according to the ordinary operation process.
10.11. Exchanging B-powder cartridge
If the powder in the B-powder cartridge becomes low or the system shifts to the Bypass mode due
to the B-conductivity alarm, exchange the B-powder cartridge by the following procedures:
No. Operation
1 Press the B-cartridge change button on the Dialysate menu screen.
2 According to the guidance displayed on the screen, exchange the B-cartridge after its drainage.
3 Press the Resume button after replacing the B-cartridge.
4 After priming of the B-cartridge, dialysate producing is restarted.
10-33
10-34
11. Specification
The specifications and appearance of the product may change without a previous notice for
improvement.
11.1. Unit Specification
11.1.1. Model, Size and mass

Specification Conditions/Note
Model NCU-18
Main unit size W: 300mm (Foot: 490mm) None
D: 490mm
H: 1470mm (Without a IV pole)
H: 1945mm (With a IV pole)
Main unit mass Approx. 100 kg (Dry mass) Including all optional parts
Workspace required
Prepare a space larger than 5cm, 10cm, and 20cm

above, each side, and back of the equipment,
respectively, with respect to the outside demension.
For ventilation, use a ventilation opening of larger
than φ20cm or avoid placing an object next to at
least one of each side or back of the equipment.
Outside demensions of the equipment
Top 300mm
W
Wheel part 490mm
D Wheel part 490mm

Excluding the infusion stand 1470mm
H
Including the infusion stand 1945mm
Fig. 1-1 Outside dimensions of the equipment
11-1
11.1.2. Drainage
Drainage flow must be 1500 mL/min or higher.

Keep the drainage tube 3 m or shorter.
The maximum height of the drain tube is 60 cm, with free outlet to avoid contamination.
Cap a drain pipe, and establish vent for the prevention of the siphon phenomenon.
Figure 1-2 Drainage
11.1.3. Electric rating

Power-supply voltage 230 V AC ± 10 %, 50 Hz/60 Hz 220V and 230V is same machine
Power-supply frequency 220 V AC ± 10 %, 50 Hz/60 Hz
110 V AC ± 10 %, 50 Hz/60 Hz
Length of the power cable: 3.0±0.1ｍ
(From the backside of the equipment to the tip
of the plug)
Power consumption 2.5kVA or less(AC230V) None
2.5kVA or less(AC220V)
1.65kVA or less(AC110V)
Leakage current In normal operation: None
Earth leakage current 0.5mA or less
Exterior leakage current 0.1mA or less
At single breakdown:
Earth leakage current 1.0mA or less
Exterior leakage current 0.5mA or less
The electric power supply necessary for the operation of the NCU-18 must conform to the
respective laws and regulations in the customer's region.
Never operate devices that cause electromagnetic interference, such as mobile phones or CB
wireless transmitters in the vicinity of the NCU-18 while the NCU-18 is in operation.
The use of any device that emits electromagnetic waves in the vicinity of the NCU-18 may
cause the NCU-18 to malfunction.
Please follow the information in the technical manual for installation and use.
11-2
Electromagnetic emissions and electromagnetic immunity
The NCU-18 is intended for use in the electromagnetic environment specified below.
The customer or the user of the NCU-18 should assure that it is used in such an environment.
! WARNING
 The use of accessories and cables other than those specified, with the exception of parts sold
by the manufacturer as replacement parts for internal components, may result in increased
emissions or decreased immunity of the equipment.
Emissions test Compliance level Electromagnetic environment - guidance

RF emissions Group 1 The NCU-18 uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions Class B The NCU-18 is suitable for use in all establishments,
CISPR 11 including domestic establishments and those directly
Harmonic emissions Class A connected to the public low-voltage power supply network
IEC 61000-3-2 that supplies the electric power to the buildings for domestic
Voltage fluctuations/ Complies purposes.
flicker emissions
IEC 61000-3-3
* EMC
Electromagnetic
Item Standard
environment-guidance
Electrostatic discharge immunity Contact discharge : ±2kV, ±4 kV, ±6 kV Floors should be wood,
IEC 61000-4-2 Air discharge : ±2kV, ±4 kV, ±8 kV concrete or ceramic title. If
Indirect contact : ±2kV, ±4 kV, ±6 kV floors are covered with
synthetic material, the
relative humidity should be at
least 30 %
Electrical fast transient/burst By the test method based on Mains power quality should
immunity IEC61000-4-4, be that of a typical
IEC 61000-4-4 Impulse height/width/spacing: ±2kV/5 commercial or hospital
nsec/50 sec environment.
*±1kV for signal and interconnecting
cables.
Impulse application: 1 minute or more
Asynchronous, impulse polarity: R phase,
S phase
Noise application: common mode and
normal mode
Surge immunity Differential mode: ±0.5kV, ±1kV Mains power quality should
IEC 61000-4-5 Common mode: ±0.5kV, ±1kV, ±2kV be that of a typical
commercial or hospital
environment.
Power frequency magnetic field Test level 3 A/m Power frequency magnetic
immunity test fields should be at levels
IEC 61000-4-8 characteristic of a typical
location in a typical
commercial or hospital
environment.
Voltage dips, short interruptions and 95% voltage dip: for 0.5 cycle Even the power supply is
voltage variations immunity 60% voltage dip: for 5 cycles interrupted, the hemodialysis
IEC61000-4-11 30% voltage dip: for 25 cycles system battery maintains the
95% voltage dip: for 5 seconds supply with no delay.
Functions operated by the
battery are limited.
Operations prior to power
failure will be maintained
after recovery.
11-3
Electromagnetic
Item Standard
environment-guidance
Radiated, radio-frequency, Frequency band: 80 MHz to 2.5 GHz Portable and mobile RF
electromagnetic field immunity Step frequency: 1.5 x10-3 decade/sec communications equipment
IEC 61000-4-3 Test field strength: 3 V/m 80 % AM, 2 Hz should be used no closer to
Residence time: 3 seconds any part of the hemodialysis
system, including cables,
than the recommended
separation distance
calculated from the equation
applicable to the frequency of
the transmitter.
Recommended separation
distance:
150kHz to 80MHz
d=1.2 √P
80MHz to 800MHz
d=1.2 √P
Immunity to conducted disturbance, 3 Vrms in 0.15-80 MHz 800MHz to 2.5GHz
induced by radio-frequency fields d=2.3 √P
IEC61000-4-6 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 metres (m).
Field strengths 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: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations 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
hemodialysis system is used exceeds the applicable RF compliance level above, the hemodialysis system
should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the hemodialysis system.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
11-4
Item Standard
Radiated Emission Noise -Frequency band 0.15 to 0.50 MHz:
Quasi-peak decreases from 63 dB to 56 dB with the
logarithm of the frequency.
Average decreases from 53 dB to 46 dB with the
logarithm of the frequency.
-Frequency band 0.50 to 5MHz:
Quasi-peak: 53 dB
Average: 43 dB
-Frequency band 5 to 30 MHz:
Quasi-peak: 57 dB
Average: 47 dB
Radiated Emission Noise -Frequency band 30 to 230 MHz: 30 dB
-Frequency band 230 to 1000 MHz: 37 dB
Protection of public mains network Max relative voltage change - dc: <= 3.3%
(220 Voltage more) Relative steady state voltage change - dmax: <= 4%
Relative voltage change - d(t): 500 ms
Voltage fluctuation and blinking Short-term blinking - Pst: <= 1.0
(220 Voltage more) Long-term blinking - Plt: <= 0.65
Recommended separation distances between portable and mobile RF

communications equipment and the NCU-18
The NCU-18 is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the NCU-18 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the NCU-18 as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter

power of transmitter m
W 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
d=1.2 √P d=1.2 √P d=2.3 √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 80 MHz and 800 MHz, 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.
11-5
! WARNING
 There is no guarantee that interference will not occur in a particular installation.
 Take the following measures if equipment causes harmful interference
- Increase the distance between the devices
- Connect the equipment to an outlet on a different circuit from that other device
- Contact the manufacturer or technician for help
11.1.4. Protection form

Protection class and Class I Cuff for BPM: Type BF applied part
grade Type B applied part
Protection against water Drip proof machine IPX1 All panels must be closed.
penetration
11.1.5. Conditions on the facility side

Water supply pressure 0.05-0.74MPa (Normal pressure) None
(0.5-7.5 kgf/cm2)
Water supply flow 900 mL/min or more Dialysate flow: 100 to 800 mL/min
Water supply temperature With a Heat Exchanger Assy: 2 to 30°C ･The water supply temperature must be
Without a Heat Exchanger Assy: 15 to 5°C or more lower than the dialysate
30°C temperature set value.
･The temperature change per min must
be ±1°C or lower.
Drainage Capacity: 1500 mL/min or more Length of the drain tube: 3 m or less
Height: 0 to 60 cm from the floor
11.1.6. Environment
Surrounding space Necessary to keep space for the equipment A ventilating hole of 20 cm or more
outer size as follows: in diameter must be equipped for
Top: 5cm or more ventilation. Otherwise, any of
Side: 10cm or more top/side/back surface must be open.
Back: 20cm or more
Operating surrounding 15 to 35 °C At least 5 °C lower than the set value
temperature of dialysate
Storage, transport 35 to 80 % Non condensing
humidity
Storage, transport With liquid in hydraulic line: 5 to 50 °C None
temperature Without liquid in hydraulic line: -10 to 50 °C
Storage, transport 35 to 85 % Non condensing
humidity
Barometric pressure When used, storage and transportation, 795 None
to 1062 hPa
11-6
Water quality Has to be suitable for dialyzing. The quality of the water should
(Water quality satisfying the provision of comply with the local regulations
ISO13959:2009) (e.g. European
For ON-LINE HDF treatment, concentrates pharmacopoeia-Ph.Eur.)
must satisfy the provision of ISO13958:2009.
Supply pressure range of 5 to 98Kpa (38 to 735 mmHg) None
Central system
! CAUTION
 If the unit is to be used after a period of 1 month or more, clean the unit thoroughly (for 1 hour or
more). Subsequently, regular inspection should be performed in accordance with “Safety
Precautions-15”
11.2. Unit performance
11.2.1. Dialysate flow

Dialysate flow Min: 100 mL/min 100mL/min step
Max: 800 mL/min
Flow accuracy From Set value 0 to 10 %
11.2.2. Air omission

Deaeration method Vacuum deaeration method None
Dissolved gas in Under PO2 140 mmHg Raw water PO2 200 mmHg (37 °C
dialysate conversion)
When the set temperature of
dialysate is 37 °C.
11.2.3. UF control
UF control method Sealed volume control method using piston pump None
Setting range 0.00, 0.10-5.00 L/h 0.01L/H step
Accuracy of UF ± 30 g/h When the equipment adjustment
condition is the same as factory
shipment
11.2.4. Temperature control

Setting range 33.0 to 39.0 °C 0.1 °C step
Stability Set value ± 0.5 °C or less None
11-7
11.2.5. Conductivity control (BICARBONATE)
Dialysate Preparation method A Concentrate None
:Quantum mixing method by the piston pump
B Concentrate
:Feedback control by the piston pump
Input range of Theoretical 24 to 70 mEq/L (Input with 1 mEq/L increment) None
Concentration of Water+B
(Concentration of Na+Electrolyte)
Concentration of Water+A+B
Calibration range of A -10 to 10(Change with 1 increment)
Calibration range of B -10 to 10(Change with 1 increment)
Stability for input range of Set value +0.30mS/cm or less None
concentration
11.2.6. Conductivity control (ACETATE)

Dialysate preparation method Quantum mixing method by the piston pump None
Concentration
Calibration range -10 to 10(Change with 1 increment)
Stability for input range of Set value +0.30mS/cm or less None
concentration
11-8
11.2.7. Cleaning
Chemical disinfection Setting range Recommended disinfection
(Sodium Hypochlorite) Concentrate concentration:1.0 to 12.0 % Concentrate after dilution:1000ppm
(0.1% increment) ･Total time:41min
Concentrate after dilution:0.01 to 0.20 % (7min pre-rinse, 20min disinfection)
(0.01% increment) ･Post time:14min
Time: Total:29 to 120min ･Setting temp.:35°C
Post: 14 to 60min
Setting temp.:30 to 40°C NOTE
Protection against corrosion * Total time includes 7 min
Concentrate concentration:6 % or less
pre-rinse (fixed) and post-rinse
Concentration after dilution
(variable).
0.03 to 0.1% or less / 1hr or less
0.03 % or less / 24hr or less
(Peracetic acid) Setting range

Concentrate concentration:1.0 to 12.0 % ! WARNING
(0.1% increment)
* Manufacturer does not secure
Concentrate after dilution:0.01 to 0.2 %
disinfection effects using
(0.01% increment)
peracetic acid. Use peracetic acid
Time: Total:29 to 120min
at each facility's discretion.
Post: 12 to 60min
Setting temp.:30 to 40°C
Protection against corrosion NOTE
Original concentration:6 % or less * Total time includes 7 min
Concentration after dilution pre-rinse (fixed) and post-rinse
0.01 to 0.02% or less / 1hr or less (variable)
0.01 % or less / 24hr or less
Hot citric Setting range Recommended disinfection

Concentrate concentration:10 to 50 % Concentrate after dilution:1.0%
(1 % increment) ･Total time:39min
Concentrate after dilution: 0.1 to 2.0 % (7min pre-rinse, 23min disinfection)
(0.1 % increment) ･Post time:9min
T2 Temp : 96 °C(fixed)
Time:39 to 60 min NOTE
Protection against corrosion * Total time includes 7 min
pre-rinse (fixed) and 9 min
Concentrate after dilution: 0.8 % or less
post-rinse (fixed)
Decalcification Setting range

(Acetic acid) Concentrate concentration:30.0 to 70.0 % NOTE
(0.1 % increment)
* Total time includes 7 min
Concentrate after dilution:1 to 5 %
pre-rinse (fixed) and post-rinse
(1 % increment)
(variable)
Time: Total:45 to 120min
Post: 14 to 60min
Setting temp.:30 to 40°C
11-9
Protection against corrosion
Concentrate after dilution: 2 % or less
Hot rinse Setting range
T2 Temp : 96 °C(fixed) NOTE
Time: 39 to 60 min * Total time includes 7 min
pre-rinse (fix) and 9 min
post-rinse (fixed)
Water rinse Setting range None

Time: 5 to 120 min
IHR Setting range Water supply temperature: 85-90°C
Time: 30 to 200 min
11.2.8. Blood pump

Blood pump method 2 roller Auto space adjustment method None
Rotation direction R rotation direction only (Clockwise rotation) During treatment
Flow range φ6.35×φ9.75mm tube : 0, 10 to 400 mL/min Obtaining maximum flow may be
φ8.00×φ12.00mm tube : 0, 10 to 600 mL/min impossible due to fatigue of the
rolling tube.
Flow accuracy Set value ±10% (10～600mmL/min) Min. inlet pressure : -200mmHg
Max. outlet pressure : +500mmHg
11.2.9. ON-LINE HDF pump

Blood pump method 2 roller Auto space adjustment method None
Flow range φ6.35×φ9.75mm tube : 0, 10 to 300 mL/min Obtaining maximum flow may be
φ8.00×φ12.00mm tube : 0, 10 to 500 mL/min impossible due to fatigue of the
rolling tube.
Flow accuracy Set value ±10% (10～500mmL/min) Min. inlet pressure :-200mmHg
Max. outlet pressure : +500mmHg
11-10
11.2.10. Heparin pump
1 tube method Nipro Syringe 10, 20, 30 mL syringe None
Injection direction Leftward only facing the equipment front side None
Flow setting 0.0 to 20.0 mL/hour None
Flow accuracy Machine accuracy ± 1 % When each setting of the syringe is
Flow accuracy ± 10 % proper
Pressure range: 0 to 450 mmHg
Overload detection Discharge pressure 1200±50mmHg None
Fast-forward injection In use of above 10 mL syringe: Approx. 550 mL/h None
In use of above 20 mL syringe: Approx. 900 mL/h
In use of above 30 mL syringe: Approx. 1200 mL/h
Pusher removal alarm To detect loss of syringe None
Rotation direction To detect wrong direction None
detection alarm
Alarm for abnormal Alarm goes off when the injection rate deviates None
injection rate from the range of +/-20 % of set value.
(A pair of photo sensors is used for monitoring
the injection rate.)
! CAUTION
* The heparin pump should be used only for infusion of heparin solution. Do not use this pump for
infusion of any other solutions!
11.2.11. Auto priming / Auto reinfusion

SPR(Support priming) Open and close at arterial line and substitution Tube size at arterial is ID 3.3 and OD
line. 5.6
Arterial clamp Normal open type
Arterial bubble sensor Alarms when over 10μL single bubble are Flow 200 mL/min
detected or over 0.3μL bubbles are detected Flow temperature 37 ± 1.0 °C
and integrated bubble in unit time (5 min)
reaches the rate value.
Rated value: Three grades of 1, 50, 100 μL
Arterial blood sensor A blood sensor is a sensor judging having blood
or not and can set the judgment level in the unit.
Substitution clamp Normal close type
Substitution detector Substitution fluid detector
Display of clamp Normal action: green light
movement Error action: red light
※When it is selected the ONLINE HDF, Auto priming / Auto reinfusion function can be used by online solution.
11-11
11.3. Safety devices
11.3.1. Venous pressure monitor

Measurable range - 500 to + 500 mmHg None
Indicated value accuracy ± 10 mmHg None
11.3.2. Arterial pressure or Dialyzer Inlet blood pressure monitor

11.3.3. TMP monitor

11.3.4. Venous Clamp

Function Closes blood line at venous side. None
（Detects air bubble at single needle, etc.）
Detection method Sets at a location at venous side. None
(Normal close type)
11.3.5. Bubble detector

Sensor method Supersonic method None
Corresponding tube φ3.4×φ5.6±0.1mm Adjust sensor in φ4.4×φ6.6
φ4.4×φ6.6±0.1mm tube at the time of factory
φ4.6×φ6.8±0.1mm installed.
Necessary to adjust by other
tubes to use in field.
Detection capability Alarms when over 10μL single bubble are Flow 200 mL/min
detected or over 0.3μL bubbles are detected Flow temperature 37 ± 1.0 °C
and integrated bubble in unit time (5 min)
reaches the rate value.
Rated value: Three grades of 1, 50, 100 μL
11.3.6. Blood leak detector

Sensor method Optical scheme(an infrared transmission method) None
Detection accuracy 0.25±0.1 mL/min Ht32 %
Detection value Setting range: 50 to 500 ppm None
(Set by the 10ppm step)
Detection point (default is 300 ppm), (Ht 32%)
11-12
11.3.7. Temperature monitor
Sensor method Thermistor None
Display ±0.6C Precision is calculated for the sensor
reproducibility alone (true temperature time : 37C)
Alarm settings Max setting range: 37.0 to 40.0 °C The average temperature is an
(Set with 0.1 °C increment) average of dialysate temperatures
Max alarm accuracy: Mean temperature ± 0.8 °C per min.
Min setting range: 29.0 to 36.0 °C
(Set with 0.1 °C increment)
Min alarm accuracy: Mean temperature ± 0.8 °C
Temperature gradient detection of T3-T4: 1.2°C
11.3.8. Conductivity monitor

Sensor type Electrode type None
Display CD1,CD2,CD3：Display value ± 2 % CD1:10.0 to 20.0 mS/cm
reproducibility CD2,CD3:1.2 to 10.0 mS/cm
Alarm setting Setting range: Base conductivity ±2.0 to ±9.9 % Base conductivity is calculated from
(Set with 0.1 % increment) concentration setting value.
11.3.9. Coagulation monitor
As protective system for blood coagulation, DC stepping motor including photo sensor is used in
blood pump. The pump error (stop) caused by blood coagulation in blood line is detected by
abnormal return pulse transmitted from the element and the alarm is activated for assuring patient
safety.
11.3.10. UF monitor
The patient is protected from the volume of the UF that danger is caused by deflection from a set
value by observing the rotational rate of the UF pump by using two photo sensors.
However, errors in the UF rate may exist to a maximum of 4% of the set value. This method does
not detect UF rate errors from other sources such as leakage.
11.3.11. Alarm buzzer

Specification Condition/Note
Sound pressure Max setting: 70±5.0 dB Five stage setting
Min setting: 48±5.0 dB
Muting time Max 2 minutes None
11.3.12. Lamp
4 colors light indicator.
(Red color is blinking when an error is detected. Refer to “7. Lamp" for details.)
11-13
11.4. Functions of standard equipment
(1) UF control
(2) Bicarbonate dialysis
(3) Acetate dialysis (Solution type stock solution used)
(4) Control of dialysate flow
(5) Single needle (Single-pump)
(6) SQUF *Sequential Ultra Filtration
(7) UF profile
(8) Stock solution profile
(9) Automatic deaerator (Closed circuit side)
(10) A and B concentrate suction tube and rinse ports
(11) Coupler Assy
(12) Cleaning program
(13) Hot water disinfection
(14) Hot-citric disinfection
(15) Analog touch panel system
(16) Start up test
(17) Self-diagnosis function
(18) Indicator light (4 colors : Red, Yellow, Green, Blue)
(19) Power failure backup (30 minutes)
(20) Kt/V (Method by software calculation)
(21) Swivel mechanism of the operation panel
(22) IHR
(23) Display language (English, Chinese (simplified Chinese, traditional Chinese))
11-14
11.5. Main display specifications
(1) UF volume (Current UF volume)

Digital display : 0.00 to 20.00 L
(2) UF goal (Target UF volume)

(3) UF rate
Digital display : 0.00, 0.10 to 5.00 L/h
(4) UF left (UF remaining time)

Digital display : 0:00 to 24:00 (0 hour 00 minute to 24 hours: 00 minutes)
(5) Current substitution volume

(6) Target substitution volume

(7) Substitution rate

Digital display : 0, 10 to 500 mL/min (5mL/min step)
(8) Venous pressure

Bar graph display and Digital display. Display range of the bar graph can be switched with the
software.
Bar graph display : -100 to +300 [mmHg] (factory installed)
-100 to +500 [mmHg]
Digital display : -500 to +500 [mmHg]
(9) Arterial pressure (or Inlet for dialyzer pressure)

software.
-300 to +300 [mmHg]
-300 to +600 [mmHg]
(10)TMP (Venous pressure-Dialysate pressure)

software.
-100 to +500 [mmHg]
11-15
(11)Dialysate pressure
software.
-500 to +500 [mmHg]
(12)Dialysate temperature
Digital display : 0.0 to 99.9 °C
(13)Dialysate conductivity
Temperature compensated display at base temperature 25 °C.
(Temperature compensation: 2.000 %/°C)
Digital display : 0.0, 3.0 to 20.0 mS/cm
(14)B concentrate conductivity

Temperature compensated display at base temperature 25 °C.
Digital display : 0.0, 0.3 to 10.0 mS/cm
(15)Heparin pump flow rate

Digital display : 0.0 to 20.0 [mL/h]
Displays integrating volume at fast forwarding, bolus injection (Range of bolus injection volume
0.0 to 9.9 mL)
(16)Blood pump flow rate

Digital display : 0, 10 to 600 mL/min (5mL/min increment)
(17)Dialysate flow rate

Digital display : 0, 100 to 800 mL/min (100mL/min increment)
(18)Others
Other items such as Blood leak value, and UFRP can be displayed.
11-16
11.6. Applicable consumables
11.6.1. Dialyzer
・ ELISIO series dialyzer

・ FB series dialyzer
・ PUREFLUX series dialyzer
・ SUREFLUX series dialyzer
・ SURELYZER series dialyzer
・ PES series dialyzer
! CAUTION
 Expected performance or functions cannot be warranted if other than the specified is used.
11.6.2. Blood Lines
Models of blood lines (Product name : NIPRO Blood line) that can be used are as follows:
Type Models
Blood line A057/V657, A060/V658
Substitution line A107
! CAUTION
11.6.3. Syringes
NIPRO: 10mL, 20mL, 30mL
! CAUTION
11.6.4. Concentrates
11.6.4.1. Acetate
34 parts water to 1 parts acetate concentrate
11-17
11.6.4.2. Bicarbonate
NIPROSOL･322A
Use pure sodium hydrogen carbonate solution as B concentrate. The followings are 3
recipes for B concentrates of typical concentration. (Calculate and input ratio according to
the B concentration.)
To be used in the dilution ratio of:-
NIPROSOL･322A (Acid) ················1.0vol
Bicarbonate (8.4％) ················1.30vol
Purified Water··························32.7vol
Bicarbonate (9.1％) ················1.20vol
Purified Water··························32.8vol
Bicarbonate (7.0％) ················1.55vol
Purified Water························32.45vol
11.6.4.3. Powder Bicarbonate (For option)
NIPROCART A2F 760
11.6.5. CF (For option)
NIPRO:CF-609N
Material Hydrophobic Polyethersulfone
Hollow Fiber Membrane Area 0.6m2
Inner Diameter 500μm
Thickness 150μm
Housing Polycarbonate
Potting Compound Polyurethane
O-ring Silicone Rubber
Maximum Operating 150kPa (150kgf/cm2)
Pressure
Pressure Loss ( 37℃ ) 0.07 kgf/cm2 at 500 ml/min
0.14 kgf/cm2 at 1,000 ml/min
Cut-off Point ( MW ) 6,000 ( Protein )
Live Bacteria Removal LRV≧8
Endotoxin Removal LRV≧4
Sterilization Gamma Ray
! CAUTION
 Expected performance or functions cannot be warranted if other than the specified is used
11-18
11.7. Option specification
11.7.1. Built-in Automatic Blood Pressure Measurement Modules, BPM-2500
Measures the blood pressure for adults and children by the module (M-2500: Omron Healthcare.
Inc.) in the equipment.
Degree of protection from electric shock : Type BF
Refer to '13 Blood pressure monitor' about the accessories.
11.7.2. BPM remote button
For connecting the maker-specified blood pressure measurements module remote button.
(WTF4409W: Panasonic Corporation)
11.7.3. CF1
The filter that removes endotoxins, bacteria, particles and other impurities.
(CF-609N: Nirpo Corpration)
11.7.4. CF leak check unit
Detect leakage of filter in CF.

Checking with negative pressure by UF pump during start up test.
11.7.5. B-Powder ASSY (optional, factory installed)
Powder Bicarbonate correspondence for preparation of B concentration. The suction volume of

B concentrate is adjusted by changing the rate of the Hicera pump that is controlled by
feedback from relevant conductivity data.
Refer to " 3. Preparation, 4.Dialysis, 5. Reinfusion" for operation.
11.7.6. Central system (2 ports for A-concentrate/1Port for A-concentrate and 1port for B-concentrate)
Connection ports corresponding to the concentrate central system which is different from the
standard concentrate port.
11.7.7. Heat exchanger ASSY
Touch with feed water and the thermal exchange before the hyperthermia are indirectly
decreased by the exchanger, and the feed water temperature before the hyperthermia of doing
is raised and the load of the heater is decreased the decrease of a hyperthermia used dialysate.
11-19
11.7.8. Auto priming / Auto reinfusion (optional, factory installed)
Auto priming and auto reinfusion are available by adding a arterial clamp, substitution clamp,
substitution detector, bubble detector for arterial and blood sensor.
*Specified tube size is φ3.3×φ5.6±0.1mm.
1. Auto priming
Perform the priming to feeding saline or online fluid by blood pump until the target volume are
achieved, and operating the clamp automatically.
2. Auto reinfusion
Perform the blood return to feeding saline or online fluid by blood pump until the target volume
are achieved, and operating the clamp automatically. Or operating the clamp automatically until
completion of blood return by detect the blood. The purpose of blood sensor is to judge that the
blood is there. The threshold can be adjusted in machine setting.
11.7.9. ON-LINE HDF (optional, factory installed)
On-line HDF / HF treatment is available by adding a ON-LINE HDF pump, a clean port, two CF
units and a leak check function are added. On-line priming and on-line reinfusion are also
available.
CF flushing unit, leak check unit (These are necessary items.) and drain port are also included.
Refer to " 12. ON-LINE HDF / HF" for operation
11.7.10. Drain port
The port that is drained used liquid in blood line during auto / manual priming. This port is
connected to the tip of venous blood line. The priming solution that passed through dialyzer and
blood line is drained through the machine.
The drain port is cleaned automatically during cleaning process.
11.7.11. External network
Conduct the communication regarding machine condition by connecting signal code of external
central network system.
Cannot use with IC card system.
11.7.12. Nurse call
The remote switch that operates the indicator light and buzzer.
(NBR-8A-C: AIPHONE Corporation)
11-20
11.7.13. IC card system(optional, factory installed)
Set the patient information for dialysis automatically via IC card.

IC card read/writer (FeliCa) of non-contact type
Cannot use with the external network.
11.7.14. Support for solutions
The cart with caster for A and B concentration tank.

It attaches at front of machine, can turn together with machine .
11.7.15. Tray for disinfectant
The tray to fix the tank of disinfection and decalcification.

It attaches at right side of machine
11.7.16. Manual fluid level adjustment mechanism (Arterial and Venous Drip Chamber)
Function that allows to adjust the fluid level of arterial and venous drip chamber via screen.
When is selected the Auto priming / Auto reinfusion, this function is mounted automatically.
11-21
11-22
12. ONLINE (OPTION)
12.1. ONLINE menu screen
ONLINE HDF or ONLINE HF treatment will be possible by turning on the "ONLINE HDF" on the
OPTION screen.
Press the Subs. menu button. The following screen will appear.
Setting item Description

Treatment mode Button to select treatment mode.
Treatment modes HDF Postdillution, HDF Predillution, HF Postdillution and HF
Predillution are available.
Auto-sub button Button to start or stop auto fluid replacement
The Sub pump rate changes according to the blood pump flow when I/O is ON.。
Sub goal Target fluid replacement volume
Setting range: 0 to 720 L
Sub rate Fluid replacement rate
Setting range: 10 to 500 mL/min
Sub volume Current fluid replacement volume
Sub pump button Button to operate fluid replacement pump
Sub Bolus one shot Settings for bolus injection (one-shot injection) are displayed.
Setting range: 10 to 200 mL
Sub Bolus rate Rate for bolus injection
Setting range: 10 to 300 mL/min
Cum. Bolus Cumulative bolus injection volume is displayed
Sub Bolus button Button to start bolus injection
12-1
! WARNING
 Before each on-line HDF/on-line HF treatment, the unit must be heat-cleaned with citric acid, or
a chemical disinfection with peracetic acid or sodium hypochlorite has to be carried out.
 The use of two Cut Filters (dialysate fluid filter) is mandatory.
- First filter is placed after the dialysis fluid preparation.
- This filtered dialysis fluid will pass true the second filter just before it will be infused as
substitution fluid in the bloodline.
 To guarantee the chemical quality, the regulation of the European Pharmacopeia in the form
valid at the time, are to be used while the regulations of the RKI (Robert Koch Institute) are to be
consulted in order to ensure the microbiological quality.
 The maximum operation time of the cut filter of 1200 hours must not be exceeded.
NOTE
 See the "4. Treatment" for the ONLINE operation.
12-2
12.2. Specification
12.2.1. ON-LINE HDF pump

Blood pump 2 roller Auto space adjustment method None
method
Flow range φ6.35×φ9.75mm tube：0 to 300 mL/min Obtaining maximum flow may be
φ8.00×φ12.00mm tube：0 to 500 mL/min impossible due to fatigue of the
rolling tube.
Flow accuracy Set value ±10% (10～600mmL/min) Min. inlet pressure ：-200mmHg
Max. outlet pressure ：
+500mmHg
12.2.2. Substitution line
Use a single-purpose blood circuit according to the treatment status as below:
Type Models
Substitution line A107
NOTE
 For the pre-online HDF treatment or pre-online HF treatment, connect the tube from the
substitution fluid pump to the port before the dialyzer
 For the post-online HDF treatment or post-online HF treatment, connect the tube from the
substitution fluid pump to the port after the dialyzer.
12.2.3. Cut Filter (Endotoxin Retentive Filter)
Models
NIPRO CF-609N
! WARNING
 Confirm if the Sub-port is closed visually when the treatment mode is other than Online
treatment. when treatment is continued in the state of leakage.
 If the treatment is started while the CF leak check result is NG, endotoxin may enter the body.
Replace the CF immediately and check that the leak check is passed. Then start the
treatment.
12-3
12.3. Auto-sub function
In order to prevent hemo concentration (clotting), this function changes the substitution fluid pump
flow according to the blood pump flow.
The flow of the substitution fluid pump is calculated based on the following formula:
1) For HDF predilution and HD predilution
Substitution fluid pump flow = Blood pump flow x (AutoSub I/O Rate (pre) /100)
The AutoSub I/O Rate (pre) is set on the System-Setting-Treatment-Online screen.
2) For HDF postdilution and HDF postdilution
Substitution fluid pump flow = Blood pump flow x (AutoSub I/O Rate (post) /100)
AutoSub I/O Rate (post) is set on the System-Setting-Treatment-On line screen.
12.4. Substitution pump one-shot operation
This function supplies substitution fluid in emergency if the patient's blood pressure drops.
Turning ON the Bolus I/O under the following condition starts one-shot operation.
* During the dialysis process

* Bypass operation is not executed (neither auto or manual).
* SQUF operation is not executed.
* Blood pump is not stopped.
* HDF postdilution, HDF predilution, HF postdilution or HF predilution is selected
During one-shot operation, the cumulated volume of infusion to the cum. bolus section is displayed.
After this operation is finished, the total infusion volume achieved during this treatment is displayed.
Turning OFF the bolus I/O during one-shot operation stops the operation forcibly to change to the
normal substitution fluid operation.
! WARNING
 When executing one-shot operation, control the patient weight while checking the total bolus
volume each time.
12-4
13. Blood Pressure Monitor (Option)
13.1. Precautions for Usage of Blood Pressure Monitor (option)
! CAUTION
 Use the specified accessories only.
 Do not use for a baby or an infant child.
 Do not use if the tube is twisted or deformed.
 Pay attention not to interfere the patient blood circulation when using this option.
13.2. Preparation
Unpacking and checking the components
When unpacking, check that all of the following components are included, and verify that each
part is undamaged.
Name of component No. of pcs. Notes
BPM ASSY 1
Adult cuff 1 No.3 REF A013ZZ
Cuff hose 1
Power cable 1
Communication cable 1
Silicone tube (3 mm ID, 6 mm OD) 1 Length: 300 mm
Air filter 1
Chassis joint (nut attached) 1
Sticker (“Cuff”) 1
Mounting screws (D: 4 mm; L: 8 mm) 2
Tie band 1
Instruction Manual 1
13-1
13.3. Blood pressure monitor screen
Selecting Function-BPM displays the following screen for setting various items related to the blood
pressure gauge.
1 2 3 4
5 6 7 8
15
9
10
11
12
13 14
No. Name Description

1 SYS Systolic blood pressure is displayed.
2 DIA Diastolic blood pressure is displayed.
3 MAP Mean blood pressure is displayed.
4 Pulse Pulse is displayed.
Inflation pressure Initial cuff pressure is displayed.
5
The inflation pressure is adjusted after the first measurement.
Link with treatment Button to link monitoring with treatment condition.
6 condition button Blood pressure is measured automatically when the pre-set blood
pressure get the out of range.
7 Interval Monitoring cycle
Quick button Button to start/stop continuous measurement (Measurement time:
8
approx. 5 minutes)
9 SYS depending button Button to start treatment depending on SYS
10 DIA depending button Button to start treatment depending on DIA
11 MAP depending button Button to start treatment depending on MAP
12 Pulse depending button Button to start treatment depending on Pulse
13-2
No. Name Description
Alarm/link conditions Alarm indication conditions can be displayed and alarm setting ranges
can be set.
Systolic blood pressure min. alarm ≤ SYS ≤ Systolic blood pressure
13 max. alarm
Diastolic blood pressure min. alarm ≤ DIA ≤ Diastolic blood pressure
max. alarm
Pulse min. alarm ≤ PULSE ≤ Pulse max. alarm
14 Treatment condition UFR (Ultrafiltration rate) and BP flow during dependent treatment
15 BPM Button to start/stop measurement
13.4. Attaching the cuff to a patient
Attach the cuff to a patient according to the following procedure.
No. Procedure
1 Wrap the cuff around a bare arm or around an arm covered in thin clothing. Thick clothing
or a rolled up sleeve (see right diagram) will cause a major discrepancy in the blood pressure
reading.
2 Wrap the cuff around the patient’s arm so that the center of the cuff’s rubber bladder
(marked by a circle in the diagram) sits on the artery of the upper arm. The hose should be
brought out from the peripheral side without bending. (The Brachial artery is located on the
inside of the patient’s upper arm.
3 The adult cuff should be wrapped around the arm tightly enough so that only two fingers
can be inserted under it, above and below the cuff.
4 Maintain the height of the cuff-wrapped upper arm artery to that of the heart’s right ventricle
during measurements.
! WARNING
 Measurement is not possible in the following cases:
-Do not wrap a cuff around an arm receiving an intravenous drip or being used for blood
transfusion, as this is dangerous.
 A misreading may occur in the following cases:
-When the height of the cuff and the heart differ. A 10cm difference may cause the blood
pressure reading to differ by a maximum of 7 to 8mmHg;
-When the cuff is improperly sized or attached to the patient;
-When the cuff is frayed. Do not use frayed cuff. The rubber bag may pop out when pressurized
and, in some case, burst.
 Beware of kinks in the cuff hose.
-If a blood pressure is taken with a kink in the hose, blood will be stopped in the arm because air
cannot escape from the cuff, which may cause peripheral function damage.
13-3
13.5. Measurement
! WARNING
 If a measurement was not possible or the measurement readings seem dubious, check the
condition of the patient and then confirm the readings using the auscultatory method or palpation
method.
 Do not wrap a cuff around an arm receiving an intravenous drip or being used for blood
transfusion, as this is dangerous.
 Measurement is not possible in the following cases:
-When the patient has a peripheral circulation disorder, extremely low blood pressure or low
body temperature;
-When the patient has frequent arrhythmia. Even if a measurement is possible for such patient,
the readings will not be very reliable.
 A misreading may occur in the following cases:
-When there exist vibrations caused by heart massage, or faint, continuous vibrations applied
from outside (e.g. technician contact). Or there exist body movements caused by patient
seizure;
-When the patient wears an improperly sized cuff;
-When the height of the cuff and the heart differ. A 10cm difference may cause the blood
pressure reading to differ by a maximum of 7 to 8mmHg;
 Beware of kinks in the cuff hose and the silicone tube during measurements. Especially, take
cautions when the patients changed their body postures.
-When the kinked hoses are used, the air may remain in the cuff even if the cuff pressure
reading indicates 0mmHg on the dialysis unit.
! CAUTION
 Do not use the Blood Pressure Monitoring (BPM) module and a cardiac defibrillator at the same
time. The functions of the BPM module are limited so that they can support only the optional
functions of the dialysis unit.
 Check that the BPM module does not obstruct blood circulation of the patients for a long period.
 If the BPM module gets wet by water or other fluids, stop the dialysis unit immediately and then
wipe off the fluids on the module completely.
 The continuous measurement mode may cause damage at the measurement site, depending on
the patient’s condition and cuff fitting technique. Consider the use of the continuous
measurement mode carefully before starting.
13.6. BPM History screen
The blood pressure history can be confirmed in the Graph screen.

Data including measuring time, SYS, DIA, MAP, Pulse (SYS…Systolic Pressure, Dia…Diastolic
Pressure, MAP…Mean arterial Pressure, Pulse…Pulse Rate) can be listed and stored up to a
maximum of eighty records. When the number of records exceeds sixty, the oldest data will be
overwritten first.
13-4
13.7. Messages
! WARNING
 If it is impossible to obtain a measurement, or if the measurement readings seem dubious, first
check the status of the patient and then confirm the readings using auscultation or palpation.
Alarms and Messages related to measurement impossibilities
-The dialysis unit prompts a message when three measurement attempts fail, or if it has decided
not to retry measurement further because of the appearance of error conditions.
-If the elapsed time for the measurement, including measurement retries, exceeds 160 seconds,
the measurement is judged to be impossible.
-When a measurement becomes impossible, the dialysis unit prompts an alarm or an on-screen
message along with a buzzer tone. To mute the buzzer, press the “MUTE” key.
Alarm and message Check item

E84 BPM pressurization error Check that the connection between the air
The cuff pressure did not reach 10 mmHg within five seconds hose and the dialysis unit or the cuff is not
from the beginning of pressurization. loosened.
Check that the air filter for blood pressure
Check the cuff & the pressure tubing gauge does not leak.
The cuff pressure did not reach a preset pressure level within a Check that the cuff wrapping is not
preset time from the beginning of pressurization. loosened.
Please check the condition of applying cuff.
Check the status of the patient, and also
The cuff pressure decreased to 10 mmHg before the
whether the cuff is fitted properly.
measurement was completed.
Measurement error with artificial motion Check if the patient is shivering or
Deflation was interrupted for more than 15 seconds due to arrhythmic.
patient’s movements. Hypertension or the patient’s body
movements may be a cause.
Measurement error with insufficient pressure
Check also that the air filter for blood
Pressurization was insufficient. pressure gauge is not clogged.
Measurement error with artificial motion or irregular pulses
Signals could not be collected properly. Check the status of the patient, and
Measurement error with artificial motion or irregular pulses whether the patient is shivering or
arrhythmic.
The measurement was impossible due to arrhythmia, the
patient’s movements, or other causes.
Check the cuff and the body motion
Time including the duration of measurement retries exceeded Check for causes that may prevent
160 seconds from the beginning of the measurement. depressurization, such as the patient’s
Check the cuff and the body motion body movement or air tube kinks.
Pulse count exceeded 160 during the measurement.

Check the cuff and the body motion Check that the patient’s arm is not bent,
and check that there are no kinks in the
The cuff pressure exceeded 300 mmHg. cuff hose.
Measurement error with a faint pulse Check the status of the patient, and also
Pulse signals were too faint to measure. whether the cuff is fitted properly.
Check the cuff & the pressure tubing Use adult cuff.
Check that the air filter for blood pressure
An infant cuff was used. gauge is not clogged.
E91 BPM response error
Communication error was detected.
E92 BPM communication port error
The measurement can be restarted from the beginning by pressing the “BPM ON/OFF” button.
13-5
Alarms related to the data exceeding the set range
-The dialysis unit prompts an on-screen alarm when the measurement results exceed the
ranges set in the screen for BPM function settings.
-The dialysis unit displays an alarm along with a buzzer sound. To mute the buzzer, press the
“MUTE” key.
Alarm display Detection conditions

E85 Highest-blood pressure max. error SYS ≥ BPM SYS ALARM MAX
E86 Highest-blood pressure min. error SYS ≤ BPM SYS ALARM MIN
E87 Lowest-blood pressure max. error DIA ≥ BPM DIA ALARM MAX
E88 Lowest-blood pressure min. error DIA ≤ BPM DIA ALARM MIN
E89 Pulse-rate max. error PR ≥ BPM Pulse ALARM MAX
E90 Pulse-rate min. error PR ≤ BPM Pulse ALARM MIN
(SYS…Systolic Pressure, DIA…Diastolic Pressure, Pulse…Pulse Rate)
Setting item Default Max. Min. Setting step
BPM SYS ALARM MAX mmHg 200 250 140 10

BPM SYS ALARM MIN mmHg 80 150 60 10
BPM DIA ALARM MAX mmHg 160 200 40 10
BPM DIA ALARM MIN mmHg 50 120 40 10
BPM Pulse ALARM MAX mmHg 170 200 60 10
BPM Pulse ALARM MIN mmHg 50 160 40 10
The BPM measurement can be restarted from the beginning by pressing the “BPM ON/OFF”
button.
13-6
Treatment condition link function
Turning ON the treatment condition link function executes setting conditions if the blood pressure
setting value exceeds an alarm value.
Normal operation
Blood pressure
Within the alarm range measurement result
Out of the alarm range

BPM link function activated
BPM link function is activated.

Please check the Bypass, UFR, Blood flow and (HDF/Sub rate) settings.　OK Yes
Or, would you like to go back the previous treatment settings? 　YES
OK
Info：Treatment setting in patient safety mode.
Bypass operation reset, BP flow change, UFR change, Sub I/O ON BPM link function continued
No
Yes
Info：Please check the UF settings.
BPM link function interrupted
13-7
Alarms related to system errors
-The dialysis unit prompts an on-screen alarm on screen when the BPM module fails.
-The dialysis unit displays an alarm along with a buzzer sound. To mute the buzzer, press the
“MUTE” key.
Message display Detection conditions
E82 BPM error Single error was detected from the BPM.
E80 BPM RAM error Error detected in the RAM of the BPM module.
E81 BPM ROM error Error detected in the ROM of the BPM module.
E83 BPM communication error Communication error was detected.
These alarms suggest the failure of the BPM module. In case of an emergency during use, it
is possible to use a fresh power source for the main dialysis unit, but great caution should be
exercised while the movement involved in this operation.
13.8. Specifications of the BPM module
Degree of protection from electric shock

Type BF
Measurements
Measurement method
Oscillometric
Measurement part
Upper arm
Pressure display range
0 – 300 mmHg
Pressure display accuracy
Within ±3 mmHg
Measurement mode
Adult mode
BP measurement ranges (adult)
Systolic (SYS) 60 – 250 mmHg
Average (MAP) 45 – 235 mmHg
Diastolic (DIA) 40 – 200 mmHg
BP measurement accuracy
Mean error and standard deviation as per AAMI SP-10
Measurement range of pulse rate
40 – 200 bpm (adult)
Pulse rate accuracy
The larger of ±2% or ±2 bpm
13-8
Safety features
Maximum cuff pressure
In normal operation: 300 mmHg
In single failure: 330 mmHg
Time to pressurize the cuff
In normal operation: ≤ 160 sec
In single failure: ≤ 180 sec
Time to depressurize the cuff
In normal operation: ≥ 30 sec
In single failure: ≥ 30 sec
Dimensions
Manufacturer and Model
COLIN Medical Technology M2500
Exterior dimensions
40 mm (W) x 60 mm (H) x 105 mm (D)
Communication
Conforms to the communication specifications of COLIN Medical Technology M2500.
Application standards
EN1060-1:Non-invasive sphygmomanometers Part1.General requirements
EN1060-3: Non-invasive sphygmomanometers Part3.
Supplementary requirements for electro-mechanical blood pressure measuring systems
IEC60601-2-30: Medical electrical equipment- Part 2-30:Particular requirements for the safety,
including essential performance, of automatic cycling non-invasive blood pressure
monitoring equipment
13-9
13.9. Technical Information
Principle of measurement
The blood pressure values are determined by measuring the small oscillations (changes) in the cuff
pressure caused by the heart’s contractions as the pressure in the cuff is released. Colin’s measurement
technology utilizes a unique deflation technique, Dynamic Linear Deflation. This cuff deflation technique
allows a Colin monitor to measure each small change in the cuff pressure oscillations that directly
correspond to the measurement’s systolic, mean, and diastolic blood pressure values.
The cuff is first increased in pressure until it reaches a pressure above arterial occlusion.
As the cuff starts to deflate, the pulse rate of the patient is determined and the deflation speed of the cuff
is modified to create a patient specific deflation speed. As the pressure decreases, small cuff pressure
oscillations are recorded that correspond to the applied pressure of the blood under the cuff as the heart
contracts. These oscillations increase in strength as the cuff pressure approaches the systolic blood
pressure values. A sudden increase in oscillation amplitude indicates that the patient’s systolic blood
pressure is now able to push blood completely through beneath the cuff. The oscillation amplitude continues
to increase as the pressure in the cuff is decreases until the mean blood pressure value is reached. The
oscillation value strength then starts to diminish and finally drop off as the diastolic blood pressure value is
reached.
The oscillometric method does not determine an instantaneous blood pressure reading like the
auscultatory method employing a microphone-type auto blood pressure monitor but, as described above,
determines blood pressure from an uninterrupted changing curve, which means that the oscillometric method
is not easily affected by external noise and electrosurgical instruments.
<<From MEASUREMENT OF BLOOD PRESSURE, L.A. GEDDES>>
13-10
13.10. Maintenance
Maintenance of the BPM module
For continued safe use of the BPM module, perform the precision tests described in the
subsection Precision tests every two years, and after any replacement or repair.
Preparation for the instrument tests

Prepare the following items before the precision tests:
Reference pressure gauge 1
500mL metallic tank 1
Syringe 1
Silicone tube (3 mm ID; 6 mm OD) 5
T-shaped tube 2
Dialysis unit (only BPM ASSY is shown in Figure 1)
Stop watch 1
Adjust the reference pressure gauge so that its error is controlled within 0.8 mmHg. The capacity of the
metallic tank should be within 500 mL±5%. If the silicone tube or the T-shaped tube is missing, contact the
distributor and order a replacement.
Connection of the test circuit

Remove the mounting screws on the BPM ASSY, and set up a circuit according to Figure 1.
Figure 1
! CAUTION
 When setting up the circuit, beware of static charge build-up.
 Keep the reference pressure gauge at the same height as the BPM ASSY.
13-11
Precision tests
Pressure test
(1) Remove the silicone tube 4 from the circuit and allow it to come to ambient pressure.
(2) Turn the of the dialysis unit power off and on. (This enables the BPM ASSY to operate
alone.)
(3) Press the Test Switch 10 to close the valve installed inside the BPM ASSY. (The valve
toggles open or closed by pressing the Test Switch. Press the switch again to open the
valve.)
(4) Ensure that the difference between the reading of the reference pressure gauge and that
of the Pressure Display 7 is within ±6 mmHg under ambient pressure.
(5) Restore the silicone tube 4 connection.
(6) Pressurize the circuit using the syringe 3 until the reading of the reference pressure
gauge 1 reaches 50 mmHg.
(7) Ensure that the pressure reading on the Pressure Display at the BPM ASSY is within 50±3
mmHg. If the pressure reading exceeds this range, contact the distributor of the BPM
module.
(10) Ensure that the pressure reading on the Pressure Display at the BPM ASSY is within
200±3 mmHg. If the pressure reading exceeds this range, contact the distributor of the
BPM module.
Name of the BPM ASSY part

8 Pressure Display
9 BPM ON/OFF switch
10 Test Switch
Air leakage test
(1) Ensure that the valve of the BPM ASSY is closed.

(2) Pressurize the circuit using the syringe 3 until the reading on the reference pressure
(3) Pinch the silicone tube connected to the syringe 3 with hemostatic forceps.
(4) Leave the circuit to stand for one minute, and then check the reading on the reference
pressure gauge 1 .
(5) Leave the circuit to stand for another three minutes. (Use stop watch.)
(6) Check that the pressure change (i.e. air leakage) over three minutes is ≤10 mmHg. If the
reading exceeds this range, return the BPM ASSY to the distributor.
(8) Pinch the silicone tube connected to the syringe 3 by hemostatic forceps.
(9) Leave the circuit to stand for one minute and check the reading on the reference pressure
gauge 1 .
(10) Leave the circuit to stand for another three minutes. (Use stop watch.)
(11) Check that the pressure change (i.e. air leakage) over three minutes is ≤ 10 mmHg. If the
reading exceeds this range, return the BPM ASSY to the distributor.
NOTE
 Perform the precision tests at ambient temperatures between 15–25 °C.
13-12
MTK protocol proposal for BPM according EN 1060-01/-03:
Option active blood pressure measurement (BPM):

The control (medical technical control MTK) is to carry out after 24 months (according to EN
1060-3), as well as after maintenance or repair work. For the MTK are only instruments with the
appropriate measurement to use!
1 Visual inspection 
2 All safety labels and symbols are on the unit and must be readable 
3 Mechanical condition is ok 
Cuff pressure 0 mmHg (set value ± 6 mmHg)
(allowable tolerance: ±3 150 mmHg (set value ± 6 mmHg)
4(TSI) mmHg; 
at mercury gauges ±6 300 mmHg (set value ± 6 mmHg)
mmHg)
Air leakage (allowable tolerance: - 6 mmHg / min. or – 18
5(TSI) test press. 300 mmHg 
mmHg / 3 min.)
6 Check of overload pressure at 320 Control function of the external measurement switch 
7 Blood pressure measurement; (measured values are plausible). 
Visual examination whether any electrical connection to the cuff or the
8(TSI) 
measurement-tube. (Pollution, etc.).
13-13
13-14
14. Card System (Option)
By using the IC card, set the treatment data before treatment as following instruction.
(1) Put the IC card on the machine.

(2) Display the patient information display.
(3) Turn on "IC card" button to read the information in IC card.
Once reading IC card has finished normally, display will be changed to patient information 1
automatically.
(4) Confirm the information shown.
Page changes with ▲▼ button, confirm patient information 2, 3, and 4.
(5) Press "Use" button, in case of using the patient data shown.
When pressed the "Use" button, each setting will set to the data shown, close the patient
information screen automatically.
14-1
14-2
Glossary
Glossary of terms used in this manual has the following meanings.
Terms Meanings
3P outlet AC outlet with a grounding terminal

Filling line The hydraulic line between a water supply inlet and a chamber
Filling complete pressure The liquid pressure in the filling line that is observed after a
chamber is filled with liquid
Filling flow rate The rate of water flown into a chamber
Air elimination tank A part that eliminates air inside a closed line
Concentrate pump The pump that controls infusion volume of A concentrate and B
concentrate
UF pump The pump that controls ultrafiltration
Closed line A closed line consists of a chamber, dialyzer, charging pump,
coupler line, etc
SQUF A therapy of only removing fluid without circulating dialysate
solution
Preparation of solution To prepare dialysate solution
Solution stop A condition where the valve, pump and heater are stopped
Auto bypass To automatically turn off and bypass V9b and V19 if a concentration
value error, dialysate temperature error or blood leakage is detected
Auto gas purge To discharge air from the air purge tank AS2 by automatically
opening V4 and V10 if air in the hermetically-sealed circuit is
trapped in the air purge tank AS2 and detected by the flow switch
Air bubble sensor A sensor (detector) for detecting air bubbles in the venous blood
circuit
Coupler line A tube line from the dialysate solution feed port “TO DIALYZER” the
dialysate sollution collection port “FROM DIALYZER”
Clamp operation To prevent air bubble inflow or excessive pressure by closing the
tube of the venous blood circuit by using a clamp (CLV)
Blood circuit A tube used for circulating blood in the body
Blood pump A pump used for circulating blood against resistance in the
extracorporeal circuit and the dialyzer
This system uses a roller-type pump.
Process switches Switches for treatment mode, cleaning mode, preparation,
reinfusion, treatment, etc.
Sequence Continuous operation of solution circuit
CPU reset To initialize the CPU functions
Heparin pump Used to operate the pusher at a preset speed per unit hour
By setting a syringe filled with heparin, a preset amount heparin per
unit hour can be supplied from the connected blood circuit heparin
line. If an excessive load is applied, the pump stops with a buzzer
sound.
Single needle A method of treatment through blood circuit, using a single injection
needle
Glossary-1
Terms Meanings
SN (single needle) warning The “single needle warning” is detected if time to reach the SN
setting time upper limit switching value from the SN lower limit switching value
or time to reach the SN lower limit switching value from the SN
upper limit switching value exceeds this setting value during single
needle operation.
Dialyzer Medical equipment (artificial kidney) used for blood dialysis
Fluid removal and dialysis are done through this dialyzer.
Chamber A hermetically-sealed chamber for a certain amount of dialysate
solution in the dialysis system
Display A message display monitor (color LCD) on the operation panel to
display various kinds of information (screens)
TMP Ultrafiltration pressure
(Trans-Membrane-Pressure) With this system, TPM is defined as “venous pressure – fluid
pressure + TMP offset”.
TMP offset A difference in head or difference in pressure due to a difference in
mounting height between the venous pressure gauge and fluid
pressure gauge
This system calculates an average of one round of “fluid pressure –
venous pressure” after 5 minutes starting the treatment process or
in one hour after starting dialysis in order to use it as TMP offset.
Conductivity A value indicating a degree of electric conductivity, which is defined
as the reciprocal of electric resistance indicating a difficulty of
conductivity
Dialysis A blood dialysis therapy to remove substances by diffusion
NC (normally closed) In case of a valve, for example, it is closed when not energized and
opened when energized.
Concentration Electrolyte concentration of Na+
Highlighted display A display which reverses the normal character color and
background color as shown below
A display which does not reverse the colors is called a normal
display.
Example) HIGHLIGHTED DISPLAY
Bypass To turn off V9b and V19 not to feed dialysate solution to the dialyzer
There are two kinds of bypasses, an “auto bypass” that is operated
automatically and a “manual bypass” that is operated manually by
the bypass button.
Buzzer An acoustic alarm to indicate an error, if any
Priming To fill the blood circuit and the dialyzer with saline before starting
dialysis
Ht (hematocrit) Red blood cells
A hematocrit value 32%, for example, indicates that there are 3.2
million red blood cells per 1mm3 of blood.
Pre-washing Preliminary washing
Hermetically-sealed circuit A closed circuit which is composed of a chamber, a dialyzer, a
dialysate pressure pump and a coupler line.
UFR (ultrafiltration rate) A ultrafiltration rate which indicates an hourly ultrafiltration amount
(L/h)
UFRP (ultrafiltration Ultrafiltration performance which indicates an hourly ultrafiltration
rate/pressure) amount (L/h*mmHg) per 1 mmHg of ultrafiltration pressure (TMP)
Glossary-2
Terms Meanings
Round A cycle of chamber switching through the next chamber switching
Blood leak detector A sensor which optically detects a leakage of blood into dialysate
solution
Glossary-3
Glossary-4
Appendix
Dialysate circuit flowchart/List of Codes
Appendix-1
List of codes
Code Name Remarks Code Name Remarks
(AF1) Air filter 1 Option (F10) Filter for central system A 2 or B 1 Option
(AF2) Air filter 2 Option FS1 Flow sensor for filling circuit
(AF3) Air filter 3 Option FS2 Flow sensor for closed circuit
Flow sensor for lack of disinfection
(AF4) Air filter 4 Option FS3
and acid solution
(AF5) Air filter 5 Option FSW Flow sensor switch at dialysate side
(AF6) Air filter 6 Option H1 Heater
(AF7) Air filter 7 Option H2 Heater
AS1 Degassing tank H3 Heater 220V/230V
AS2 Air elimination tank (HEX) Heat exchanger Option
(AS3) Air elimination tank Option HP Heparin pump
Valve to relief level adjustment circuit
(AV1) Option (LAP) Adjustment pump for chamber level Option
pressure
(AV2) Valve to change pre. dialysate level Option (LED1) Clamp indicator Option
(AV3) Valve to change venous level Option LED2 Clamp indicator
BD1 Bubble detector (side of venous) (LED3) Clamp indicator Option
(BD3) Bubble detector (side of arterial) Option LS1a Temperature limit switch
(BD4) Bubble detector (side of saline) Option LS1b Temperature limit switch
BLD Blood leak detector LS1c Temperature limit switch 220V/230V
BP Blood pump LS2a Coupler switch
BPC1 Blood pump cover switch LS2b Coupler switch
BPC2 Blood pump cover switch LS3 Switch for heparin overload
BPHU Hole sensor U LS5 Location sensor for venous clamp
BPHV Hole sensor V LS6 Sensor for heparin pusher falling
BPHW Hole sensor W (LS7a) Open/close sensor for B cartridge Option
(BSA) Blood sensor (side of arterial) Option (LS7b) Open/close sensor for B cartridge Option
BSV Blood sensor (side of venous) (LS8) Location sensor for saline clamp Option
BTB Buffer tank B (LS10) Location sensor for arterial clamp Option
BTD Buffer tank D LS11 A concentrate connector
BTW Buffer tank W LS12 B concentrate connector
Open/close sensor for coupler and
BTH Buffer tank H LS14
concentrate connector cover
Ca Chamber A (LS15) Location sensor for clean port Option
Cb Chamber B (LS16) Location sensor for clean port Option
(CA1) Check valve 1 Option NV1 Adjustment valve for filling volume
(CA2) Check valve 2 Option NV4 Adjustment valve1 to remove gas
CD1 Dialysate conductivity sensor NV5 Adjustment valve for dialysate flow rate
CD2 B concentrate conductivity sensor NV6 Adjustment valve for dialysate flow rate
CD3 B concentrate conductivity sensor NV7 Adjustment valve 2 to remove gas
(CF1) Micro ultra filtration filter Option P1 Degassing pump
(CF2) Micro ultra filtration filter Option P2 Filling pump
(CLA) Arterial clamp Option P3 Pump for A concentrate
(CLS) Saline clamp Option P4 Pump for B concentrate
CLV Venous clamp PD Dialysate pressure sensor
Liquid level adjustment pressure
F1 Water supply filter (PG1) Option
sensor
Sensor for pump rotation of A
F2 Dialysate filter PH1
concentrate
F3 A concentrate filter PH5 Sensor for UF pump rotation
F4 B concentrate filter PH6 Sensor for UF pump rotation
F5 Disinfectant filter PH7 Sensor for HP pump rotation
F6 Acid solution filter PH8 Sensor for HP pump rotation
(F7) V4 line filter Option PPD(PA) Filter inlet (Arterial) pressure sensor
(F8) B powder filter Option PR Reducing valve to feed water
(F9) Filter for central system A 1 Option PV Venous pressure sensor
Appendix-2
Code Name Remarks Code Name Remarks
Solenoid valve A for bypass of
R4 Orifice for dialysate flow rate V9a
dialysate
Solenoid valve B for bypass of
R5 Orifice for A concentrate V9b
dialysate
R6 Orifice for dialysate flow rate V10 Solenoid valve to remove gas
R7 Orifice for B concentrate V11 Solenoid valve for rinse
RV1 Relief valve1 V12 Solenoid valve for disinfectant
RV2 Relief valve2 V17 Solenoid valve for decalcification
Solenoid valve C for bypass of
(SFP) Fluid replacement pump Option V19
dialysate
(SFPC1) Fluid replacement pump cover switch Option V21 Solenoid valve for flushing
(SFPC2) Fluid replacement pump cover switch Option (V23) Solenoid valve for CF leak check Option
Solenoid valve 1 to de-air from B
(SFPHU) Hole sensor U Option (V24) Option
powder
Solenoid valve to feed water to B
(SFPHV) Hole sensor V Option (V27) Option
powder
Solenoid valve to remove water from B
(SFPHW) Hole sensor W Option (V28) Option
powder
Solenoid valve for B powder and
SL1 Sample port1 (V29) Option
central system B1
(SL2) Clean port 1 Option (V30) Solenoid valve for B concentrate Option
Solenoid valve 2 to de-air from B
(SL3) Clean port 2 Option (V31) Option
powder
Solenoid valve to relief hot water
T1 Temperature sensor 1 V33
pressure
T2 Temperature sensor 2 V34 Solenoid valve for recirculation
T3 Temperature sensor 3 V35 Solenoid valve to block hot water
T4 Temperature sensor 4 (V36a) Solenoid valve for flushing CF2 Option
T5 Temperature sensor 5 (V36b) Solenoid valve for clean port 1 Option
T6 Temperature sensor 6 (V36c) Solenoid valve for On-Line HF Option
T7 Temperature sensor 7 (V43) Solenoid valve for central system A1 Option
UFP Ultra filtration pump V44 Solenoid valve 1 for sheath cleaning
V1 Solenoid valve to feed water （V45） Solenoid valve 1 for central system A1 Option
V4 AS2 solenoid valve （V46） Solenoid valve 2 for central system A1 Option
Solenoid valve 1 for central system A2
V5a Solenoid valve A for fresh Ca （V47） Option
or B1
Solenoid valve 2 for central system A2
V5b Solenoid valve B for fresh Ca （V48） Option
or B1
V6a Solenoid valve A for Ca drainage V51 Solenoid valve 2 for sheath cleaning
V6b Solenoid valve B for Ca drainage V52 Solenoid valve for flow change
V7a Solenoid valve A for fresh Cb (V53) Solenoid valve to for clean port 2 Option
V7b Solenoid valve B for fresh Cb V55 Solenoid valve to feed water
V8a Solenoid valve A for Cb drainage V56 Solenoid valve for disinfectant
V8b Solenoid valve B for Cb drainage V57 Solenoid valve for decalcification
Appendix-3
Electrical Construction
Appendix-4
Process transition paths
Machine Startup
Auto
Selection of Mode
(Treatment or Cleaning)
Manual Manual
(Touch Cleaning button) (Touch Treatment button)
Dialysis waiting
Cleaning processes
processes
Manual Manual Manual

(Touch Cleaning button) (Touch Preparation button) (Touch Preparation button)
Preparation process
Closed circuit leak check

(Must pass the test)
Dialysate preparation
(Temperature and Conductivity must be withing
the alarm limit for 5 consecutive seconds.)
CF flashing
Manual Automatic
(Touch Cleaning button) (After operations above)
Preparation complete process
Automatic
(when blood sensor detects blood)
Manual Manual
(Touch Cleaning button) (Touch Treatment button)
Treatment process
Manual Manual
(Touch Treatment button) (Touch Reinfusion button)
Reinfusion process
Appendix-5
Screen transition paths
Start up
Power ON
screen
Mode select Treatment mode

Dia./BTS
Priming
Treatment UF Dialysate Subs. SN change
mode menu menu menu menu
First aid I/O
Cleaning
Power fail
Heparin
POWER FAILURE
SCREEN BPM I/O
Power fail
System
Cleaning mode Treatmentmode
Start Setting Maintain Maker Function
Cleaning Cleaning select Cleaning
mode
Auto power off A B C D
Stop
Power OFF
A. Setting B. Maintain C. Maker D. Function

1 2 3 1 2 3 1 2 3 1 2 3
Alarm Basic Characteristics Alarm overridden Data Dialysis graph Softw are update Language update Parameter setting BPM Dose finder Timer
4 5 6 4 5 6 4 5 6 4 5
Cleaning Concentration First aid Filling process Flow chart Machine history Passw ord Screen calibration Communication setting Patient information Patient setting change
7 8 9 7 4
Option Pressure Prep.rein Operating time Sampling
A. Setting
10 12
Sound Treatment
Appendix－6
Material(intended to come into contact with the water, dialysing fluid,
dialysing fluid concentrate)
Material name
Polypropylene
Silicone rubber
Polycarbonate
Fluoro rubber
Fluorocarbon polymers
Polyethersulfone
Polyphenylenesulfide
Poly Sulfone
Polypropylene
SUS316
Alumina ceramic
Appendix-7
Appendix-8
Manufacturer NIPRO CORPORATION
3-9-3 HONJYO-NISHI, KITA-KU, OSAKA, JAPAN 531-8510
PHONE +81-6-6372-2331
CK1105-1311-ENG0 (01 Nov. 2013)

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Single patient dialysis machine

1. Unit configuration ························································································ 1-1

1.1. Overall views································································································· 1-1

2. Message display monitor ············································································2-1

2.1. At machine start-up ···················································································· 2-1

3. Preparation ··································································································· 3-1

3.1. Turning on the NCU-18 ·············································································· 3-1

4.1. Start of treatment ······················································································· 4-1

5.1. Reinfusion ··································································································5-1

6. Cleaning operation ······················································································ 6-1

6.1. Setting of cleaning pattern·········································································· 6-2

7. Light indicator ······························································································ 7-1

7.1. Light indicator specifications 1 ··································································· 7-1

8. Alarm operations and recovery ·································································· 8-1

8.1. Description of alarms·················································································· 8-1

9. Power failure backup··················································································· 9-1

9.1. Power failure backup ·················································································· 9-1

10. Other functions ···························································································· 10-1

10.1. UF menu ···································································································· 10-1

11.1. Unit Specification ······················································································· 11-1

12. ONLINE (OPTION) ····················································································· 12-1

12.1. ONLINE menu screen ················································································ 12-1

13. Blood Pressure Monitor (Option) ·······························································13-1

14. Card System (Option) ·················································································· 14-1

Glossary ··············································································································· Glossary-1

This instruction manual describes operation with standard functions.

Copyright of this instruction manual is protected and owned by the manufacturer.

Intended operators of this machine

Do not use high potassium percentage hemodialysis concentrates for HYPERKALEMIA.

Daily inspection by operator

Service and maintenance by technician

Service, maintenance, adjustments, repairs or modifications can only be performed by the

Equipment classification and handling precautions

This machine is classified as follows:

Precaution for fluid penetration

Keep the machine out of water.

Precaution for flammable atmospheres

Do no use this machine in flammable atmospheres.

(2) Annotation and its display

1. This unit should be operated by skilled personnel only.

2. Important notes concerning the installation of the machine:

3. Important notes concerning the use of the machine:

4. Important notes concerning the operation of the machine:

5. Important notes concerning the end of the treatment:

7. Do not modify the unit.

8. Maintenance (See on and after "Safety Precautions-13".)

Emergency stop using the I/O power key

Emergency stop using the power breaker

Disposal of the Lead Acid battery for power failure backup

Upon disposing the product

Risk of tilting when inclined by more than 5゜.

General warning sign

Stand-by or preparatory state for a part of equipment

Type B applied part

Type BF applied part

Handling the equipment

Use the parts specified by the manufacturer.

Liability for readjustment and repair

A person who readjusted or repaired is liable for consequential events.

Clean the air filter of the fan.

Maintenance and inspection by service technician

Inspection after long-term storage

Instructions on the maintenance and inspection log

(1) When to maintain and inspect