Nipro Surdial 55+ Maintenance manual 1
Single patient dialysis machine
SURDIAL 55Plus
Instruction Manual
-- M a i n t e n a n c e M a n u a l - -
!
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 a safe place for future reference.
Original Instructions
Intended Use of This Machine
This machine should be used when physicians prescribe hemodialysis to patients with acute or
chronic renal failure.
Contraindications
This machine is not designed, manufactured, or sold for other use than hemodialysis on patients
with acute or chronic renal failure.
Attention should be paid to contraindications valid for extracorporeal treatment in general.
Safety
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 to have a protective earth connection with the equipped power plug.
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-1
Safety Precautions
Appropriate operation and regular maintenance are essential for safe use of this machine.
Read and understand careful the safety precautions described in this manual before using or servicing
this machine.
The operating procedures and precautions described in this manual are effective only when this
machine is used for its intended purposes. Users shall be liable for all deeds and the safety measures
taken when the machine is used in methods other than specified in this manual.
(1) Degree of damage to health and property, and its indication (Alert symbols and signal words)
The degree of the foreseeable damage to health and property when the machine is misused is
classified into the following three categories, and each category is expressed by the following alert
symbol and signal word.
!
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) Note and its indication
NOTE
Indicates note sentences. Make reference when operating or servicing the
machine.
Due to our constant research and improvement, details of the design of the machine 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.
Preface-2
Table of Contents
Intended Use of This Machine
Contraindications
Safety
Safety Precautions
1.····Installation Environment············································································1-1
1.1. Installation environment ··································································································1-2
1.2. Workspace required········································································································1-2
1.3. Electric power equipment································································································ 1-3
1.4. Water supply and drainage requirements ·······································································1-3
2.····Precautions for Maintenance·····································································2-1
2.1. Precautions before handling·························································································· 2-2
2.2. Handling the equipment ································································································ 2-2
2.3. Replacement parts ········································································································ 2-2
2.4. Liability for readjustment and repair ··············································································2-2
3.····Daily Inspection ··························································································3-1
3.1 Daily inspection by operator ·························································································· 3-2
3.2 Monthly inspection ········································································································ 3-2
3.3 Maintenance and inspection by Service Technician······················································ 3-2
3.4 Maintenance by Service Technician·············································································· 3-2
3.5 Inspection after a long-term storage·············································································· 3-2
4.····Maintenance and Inspection Instructions ················································4-1
4.1. Maintenance and inspection instructions······································································· 4-2
4.2. Instructions on the maintenance and inspection log······················································ 4-3
5.····Maintenance and Inspection Log ······························································5-1
6.····Maintenance and Inspection Manual ························································6-1
Table of Contents-1
7.····Parts Replacement ·····················································································7-1
7.1 List of parts to be maintained and replaced··································································· 7-2
7.2 Parts replacement during maintenance········································································· 7-9
7.3 Miscellaneous part ········································································································ 7-48
7.4 Powder Bicarbonate Assy (option) ················································································ 7-50
7.5 Hot disinfection with citric acid Assy (option)································································· 7-55
8.····Terminology ································································································8-1
9.····Other Adjustments ·····················································································9-1
9.1 Zero compensation of the blood leak detector (BLD-01) ··············································· 9-2
9.2 Adjustment of Overload Sensitivity in Heparin Pump Assembly···································· 9-5
Table of Contents-2
1. Installation Environment
1.1. Surrounding environment
1.2. Workspace required
1.3. Electric power equipment ··············································································· 1-3
1.3.1. For the 230V (AC) unit··············································································1-3
1.3.2. For the 110V (AC) unit··············································································1-3
1.4. Water supply and drainage requirements······················································ 1-3
1.4.1. Water supply pressure ··············································································1-3
1.4.2. Water supply flow ······················································································ 1-3
1.4.3. Water supply temperature ········································································· 1-4
1.4.4. Drainage ···································································································· 1-4
················································································ 1-2
························································································ 1-2
1-1
The following conditions are required for the installation environment in order to use this
equipment safely and properly.
1.1. Surrounding environment
During operation
Storage and shipping
(with internal fluid)
Storage and shipping
(without internal fluid)
Surrounding temperature
Surrounding humidity (%)
(°C) 15 to 35 5 to 50 -10 to 50
35 to 80
(non condensing)
Air pressure (hPa)
Do not expose this equipment to direct sunlight.
1.2. 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 in diameter or avoid placing an object
next to at least one of the 5 open sides of the
equipment.
Outside demension of the equipment
35 to 85 (non condensing)
795 to 1062
NOTE
1-2
Top
290 mm
W
Wheel part
Wheel part
D
Excluding the infusion stand
490 mm
440 mm
1365 mm
H
Including the infusion stand
1930 mm
Figure 1-1 Outside dimensions of
the equipment
1.3. Electric power equipment
1.3.1. For the 230V (AC) unit
The unit requires an 230 V (AC) ±10%, 50/60 Hz power source for proper operation.
A power outlet of 230 V (AC), 10 A or larger with protective earth is required for the standard
machine.
A power outlet of 230 V (AC), 15 A or larger with protective earth is required for the machine
with Hot Citric Option.
Be sure to connect the power plug properly.
1.3.2. For the 110V (AC) unit
The unit requires an 110 V (AC) ±10%, 50/60 Hz power source for proper operation.
A power outlet of 110 V (AC), 15 A or larger with protective earth is required for the standard
machine.
A power outlet of 110 V (AC), 20 A or larger with protective earth is required for the machine
with Hot Citric Option.
Be sure to connect the power plug properly.
!
WARNING
Do not use an AC power plug or adaptor that requires protective earth removal.
Do not use an adaptor for the equipment plug when connecting to the power outlet.
For any problem with the electric power equipment, contact an authorized electrician to check
the wiring.
1.4. Water supply and drainage requirements
Check the following to ensure the proper equipment operation.
1.4.1. Water supply pressure
The normal pressure between 0.05 and 0.74 MPa (0.5 to 7.5 kgf/cm2) is required.
1.4.2. Water supply flow
(1) Standard specification
The water supply flow must be 700 mL/min or higher.
(2) Hot Citric Assy, Variable Dialsate Flow Assy and Mass Flow Assy
The water supply flow must be 900mL/min or higher.
1-3
1.4.3. Water supply temperature
(1) Standard specification
A range of 17 to 30°C is necessary.(4 to 30°C with the Heat Exchanger option)
The water supply temperature is minimum 5°C lower than the preset temperature of
dialysate.
(2) Hot disinfection with citric acid Assy, Variable control of dialysate flow Assy and high flow
Assy
A range of 14 to 30°C is necessary. (4 to 30°C with the Heat Exchanger option)
The water supply temperature is minimum 5°C lower than the preset temperature of
dialysate.
1.4.4. 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.
1-4
Figure 1-2 Drainage
2. Precautions for Maintenance
2.1. Precautions before handling··········································································· 2-2
2.1.1. Service technician····················································································2-2
2.1.2. Well-planned maintenance········································································ 2-2
2.1.3. Clothes ······································································································ 2-2
2.2. Handling the equipment·················································································· 2-2
2.3.
Replacement parts·························································································· 2-2
2.4. Liability for readjustment and repair·······························································2-2
2-1
2.1. Precautions to be taken before handling
!
CAUTION
Do not connect the equipment to a patient during maintenance.
2.1.1. 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.
2.1.2. 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.
2.1.3. 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.
2.2. 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.
2.3. Replacement parts
Use the parts specified by the manufacturer.
2.4. Liability for readjustment and repair
A person who readjusted or repaired is liable for consequential events.
2-2
3. Daily Inspection
3.1 Daily inspection by operator··········································································· 3-2
3.2 Monthly inspection··························································································· 3-2
3.3 Maintenance and inspection by service technician······································· 3-2
3.4 Maintenance by service technician································································3-2
3.5 Inspection after a long-term storage······························································3-2
3-1
!
CAUTION
Do not connect the equipment to a patient during maintenance.
3.1. Daily inspection by operator
Check the following items before and after using the equipment on the same day.
Ensure normal operation of the equipment.
Abnormality, such as leakage around the equipment.
Check loosening of clamps for the water supply opening and drainage opening hoses.
(1) There not being residual chemical solution.
(2) Residual quantities of disinfection or acetic acid solution being enough.
(3) Consumption of disinfection or acetic acid solution being reasonable.
(4) The real concentration of dialysate being reasonable.
(5) There not being abnormal sound, a bad smell, over heat.
(6) The filter of the fan not having blocking.
(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.
3.2. Monthly inspection
Clean the air filter of the fan. (See 7.3.1., 7.3.2.)
3.3. Maintenance and inspection by service technician
Check the working hours. Perform a periodical inspection every 5000 hours or every 6 months.
See “5. Maintenance and Inspection Log” for items to be inspected.
3.4. Maintenance by service technician
Check the working hours. The service technician should maintain the hydrauric line and electrical
board every 5000 hours or every 6 months.
3.5. 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 “4. Maintenance and Inspection
Instructions.”
3-2
4. Maintenance and Inspection Instructions
4.1. Maintenance and inspection instructions······················································· 4-2
4.2. Instructions on the maintenance and inspection log····································· 4-3
4-1
!
CAUTION
Do not connect the equipment to a patient during maintenance.
4.1. Maintenance and inspection instructions
The maintenance and inspection log shown in the next chapter 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 “6. Maintenance and Inspection Manual” 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 4.2. Make a copy of this form before logging.
4-2
4.2. 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 model of the equipment.
(3) Record the serial number of the equipment.
(4) Record the duration of the equipment operation.
(5) Record the date when the equipment was installed.
(6) Record the date when the equipment was inspected.
(7) Record the name of the person who inspected.
(8) 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
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.
EXAMPLE) 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.
(9) Use the “Observation and Notes” column to write information, such as the part exchanged
during maintenance and inspection, when necessary.
Required disassembly for
inspection
NOTE
Execute maintenance and inspection, make sure to keep the maintenance record, and store the
record properly.
!
CAUTION
Dialysate and body fluid can cause infection. Never exchange parts before rinsing the hydraulic
lines.
4-3
4-4
5. Maintenance and Inspection Log
5-1
)
2
)
2
9.Other items to inspect
6.Heparin pump area
6 Dialysate flow rate
(STANDBY, DIALYSIS, RINSING)
(calibration for blood-leak detection)
between displayed and infused volumes
6 Blood leak alarm Stain, leakage, or blockage in filters
alarm
leak
Blood
Observation and Notes
5-2
displayed and actual flow volumes
, or blockage in filters (calibration of the dialysate pressure gauge) 6 Damage/deformation that interfere with functions
leakage
Maintenance and Inspection: 6-month inspection => 6 12-month inspection => 6+
Equipment model: Serial No. of the equipment: Duration of equipment operation:
Date of equipment installation: / / Date of inspection: / / Inspector:
Results of inspection (Inspected: , Disassembled: , Exchanged: X, Adjusted: A, Tightened: T, Cleaned: C, Lubricated: L)
Inspector’s signature:
6 Conditions of connection tubes (bending, etc.) 6 Movement of the heparin pump 6 Bending, leakage, staining, etc of tubes
6 Connection to the drain pipe 6 Loosening of the heparin pump pulley 6 Abnormal sound/smell
6 Presence of damage and connection of cables Consistency
6 Conditions of the grounding conductor 6 Presence of air bubbles in the hydraulic line
6 Damage/deformation that interfere with functions 7.Movements of monitoring and indication alarms 6 Leakage from the hydraulic line
1.Externals, connection tubes, and cables
6 Conditions of the light indicator 6 Temperature-related alarms 6 Filling flow rate (660 to 680 mL/min)
6 Conditions of tubes (bending, etc.) (calibration of concentration indication) 6 Dialysate flow rate
6 Movement of the solenoid valve 6 Venous pressure alarm Tightening the terminal block
6 Movement of the reducing valve (calibration of the venous pressure gauge)
(calibration of temperature indication) 6 Filling complete pressure
2.Water supply, concentrate feeder, and drainage areas 6 Dialysate concentration alarm 0.093 to 0.098 MPa (0.95 to 1.0 kgf/cm
6 Check of the degassing part 6 Arterial pressure alarm 10.Powder Bicarbonate Assy (Option)
6 Movement of the degassing tank (calibration of the arterial pressure gauge) 6 Movement of the solenoid valve
Stain,
6 Conditions of rinse ports 6 Dialysate pressure alarm 6 Bending, leakage, staining, etc of tubes
6 Movement of the solenoid valve 6 Tube error alarm 11.Variable control of dialysate flow Assy and hi Flow Assy (Option)
6 Flow meter display (movement of the air bubble detector) 6 Filling flow rate (880 to 950 mL/min)
6 Movement and leakage in concentrates/UF pumps 6 Insufficient water supply 6 Filling complete pressure
6 Movement during gas purge 6 Alarm buzzer 0.113 to 0.118 MPa (1.15 to 1.2 kgf/cm
3.Closed line area (movement of the blood leak detector)
6 Movement and adjustment during BYPASS
6 Movement of the solenoid valve 6 Short circuit breaker operation
6 Residual disinfectant/acid solution (option) 6 Capacity of the battery for power failure backup
4.Disinfectant/acid solution (option) feeder areas 8.Electric tests
6 Conditions of the tube (bending, etc.) Leakage current
Conditions of the equipment with grounding
between
Consistency
6 Loosening and abnormal sound in the rotating part
5.Blood pump area
6. Maintenance and Inspection Manual
6-1
3 m
60 cm.
<
Height at the tip of the drain tube:
(2) Length of the drain tube: <
(2) OK if the equipment functions normally
(3) Must not be damaged
(4) Must be connected to a 3P outlet (5) Must not be damaged/deformed
opening and dialyzer coupler must
be closed with a metallic band and
binding band, respectively.
(1) The water supply opening / Drainage
(1) OK if the equipment functions normally
ndicator movements is preset to “1”.
(6) The criteria is applied when the light
conditions
(6) Must light / blinking under the following
Red: lights during the alarm emergence
Yellow: blinking during the standby
process
Green: blinking during the rinse
process
Blue: blinking when timer comp
Exchange the tube with leakage
(1) OK if the equipment functions normally
(2) Must have the movement sound
6-2
Inspection item Inspection method Criteria Note
1. Externals, connection tubes, and cables (1) Conditions of connection tubes.
(1) Visual inspection.
(bending, etc.)
(2) Visual inspection.
(2) Connection to the drain pipe.
(3) Visual inspection.
of cables.
(3) Presence of damage and connection
(4) Visual inspection. (5) Visual inspection.
(4) Conditions of the grounding conductor.
(6) Visual inspection.
with functions.
(5) Damage/deformation that interfere
(6) Conditions of the light indicator.
(1) Visual inspection.
drainage areas
2. Water supply, concentrate feeder, and
(1) Conditions of tubes. (bending, etc.)
(2) Check the movement from MAINTE4.
(2) Movement of the solenoid valve.
specified
2
(2) Only a standard specification.
20 mL/min
(4) Adjust using a pinchcock.
(5) Adjust using a pinchcock.
Only a standard specification.
310 mmHg)
(3) Must be 0.037 to 0.041 MPa (280 to
turn on V1, V4, V10 and (V35) from
(3) While water is supplied to the equipment,
MAINTE4. Leave them for approx. 30 sec
and turn OFF V4. Measure the pressure
between the reducing valve and V1.
(4) Must be the PO
(4) Collect the dialysate from the sample port
(5) Water should not exit from the air side
in the standby process.
process.
(5) Visual inspection during the standby
(6) No fluid leakage (7) Must have no stain, leakage, or
(6) Visual inspection during the rinse process. (7) Visual inspection.
blockage
(1) Movement sound must be audible
(1) Operate the equipment manually from
20 mL/min.
between BYPASS and RELE must be
<
coupler line during BYPASS.
(2) Changes in flow must be <
(3) Pumps rotate smoothly
MAINTE4.
process.
(2) Visual inspection during the standby
(3) Perform UF and inspect visually.
(4) Dialysate pressure must be –100 to 0
(4) Short line the FSW connector during the
mmHg
standby process and operate gas purge.
(5) Dialysate must be flowing into the
process.
(5) Visual inspection during the standby
Difference in flow meter displays
Inspection item Inspection method Criteria Note
concentrates/UF pumps.
(3) Movement of the reducing valve.
(4) Check of the degassing part.
(5) Movement of the degassing tank.
(6) Conditions of rinse ports. (7) Stain, leakage, or blockage in filters. 3. Closed line area (1) Movement of the solenoid valve.
(2) Flow meter display.
(3) Movement and leakage in
(4) Movement during gas purge.
BYPASS.
(5) Movement and adjustment during
6-3
0.1 ppm.
(2) Use water and measure the flow
volume per min with an electric
balance.
Grease No.: MOLYKOTE
(1) Apply grease on the feed screw part.
BR2 Plus Grease (Dow Corning)
(3) Adjust from MAINTE6 “SYRINGE
RATIO,” if the difference is larger.
10%.
(1) Movement sound must be audible.
MAINTE4.
(1) Operate the equipment manually from
have abnormal sound.
(2) Residual chlorine must be <
min before the water rinse ends in the
(2) Collect a sample from the drain opening 5
(3) OK if the equipment functions normally.
disinfection process.
(3) Visual inspection.
(1) The rotating part should not be loose or
(1) Check the externals and sound.
volume must be 126 to 154 mL/min.
(2) When the display is 140, actual flow
blood line.
(2) Measure the actual flow volume using the
When the display is 330, the actual flow
volume must be 297 to 363 mL/min.
(1) Must move smoothly.
system.
(1) Push the pusher manually to free the
(2) OK if not loose. (3) The difference between the actual and
(2) Tighten the set screw on the pulley. (3) Install a syringe pump with filled with water
preset infusing volumes must be <
and operate at 9.9 mL/hr for 60 min.
6-4
Inspection item Inspection method Criteria Note
areas
4. Disinfectant/acid solution (option) feeder
(1) Movement of the solenoid valve.
(option)
(2) Residual disinfectant/acid solution.
(3) Conditions of the tube. (bending, etc.)
5. Blood pump area (1) Loosening and abnormal sound in the
rotating part.
actual flow volumes.
(2) Consistency between displayed and
6. Heparin pump area
(1) Movement of the heparin pump.
(2) Loosening of the heparin pump pulley. (3) Consistency between displayed and
infused volumes.
±0.5 °C.
(1) Difference must be <
2 mEq/L.
out of range.
(2) Difference must be <
(3) Alarm is active when the current level is
out of range.
(4) Alarm is active when the current level is
out of range.
(5) Alarm is active when the current level is
(6)Real Blood leak value must be <150.
(7) Alarm is active.
(8) Alarm is active
(9) OK if buzzer sound is normal. (10) The Real blood leak value is the total
of the specified value of the dummy
simulated filters ±80 ppm.
Turn on the BUBBLE
temperatures in the preparation process.
(1) Compare preset and displayed
(2) Compare displayed and actual
concentration in the preparation
process.
(3) Change the alarm range manually in
Dialysis waiting process.
(4) Change the alarm range manually in
Dialysis waiting process.
(5) Change the alarm range manually in
Dialysis waiting process.
(6) Set the temperature to 36.5 °C in the
preparation process. Read theReal blood
leak value in MAINTE MODE1.
detector.
(7) Remove the tube from the air bubble
DETECTOR switch.
(8) Operate the equipment after decreasing
the water supply to a insufficient level.
the Real blood leak value in MAINTE1.
(9) Check the buzzer sound. (10) Install a simulated blood leak filter. Read
Inspection item Inspection method Criteria Note
(calibration of blood-leak detection)
(calibration of temperature indication)
(1) Temperature-related alarms.
alarms
7. Movements of monitoring and indication
(calibration of concentration indication)
(2) Dialysate concentration alarm.
(calibration of the venous pressure gauge)
(3) Venous pressure alarm.
(calibration of the arterial pressure gauge)
(4) Arterial pressure alarm.
(calibration of the dialysate pressure gauge)
(5) Dialysate pressure alarm.
(movement of the blood leak detector)
(6) Blood leak alarm.
(movement of the air bubble detector)
(7) Tube error alarm.
(8) Insufficient water supply.
(9) Alarm buzzer. (10) Blood leak alarm.
6-5
mL/min.
(2) Set the blood pump flow at 150
Set the heparin pump flow at 2.0
mL/h.
Start after charging for 48 hrs.
A new battery allows approx. 30 min
of operation with full charge. The
battery gradually deteriorates
although there is no power failure.
(3) The jig to measure leakage current is
necessary.
The standard of the jig must be in
accordance with JIS-T-1002.
OFF.
(4) The power breaker must be turned
(1) OK if power supply shuts off.
circuit breaker.
(1) Operate the switch to check the short
must operate for >20 min.
(2) The blood pump and heparin pump
and air bubble detector. Turn on the
(2) Attach the blood line on the blood pump
NOTE: It must operate for 20 min,
BLOOD PUMP, HEPARIN PUMP and
considering the time it takes to
complete blood collection in case of
BUBBLE DETECTOR switches. Turn off
the equipment breaker. Mute the buzzer by pressing the
0.5 mA.
The blood pump must stop when the
power failure. This time frame may
vary, depending on the age of the
battery. Exchange the battery if
necessary. Check the following function:
MUTE/RESET switch.
At the same time, check:
sensor detects air bubbles.
· Air bubble detector is on
Remove the blood line from the air bubble
detector.
· Air bubble detector
(3) OK if <
(3) Connect the jig to measure leakage
current to the equipment. Measure the
current in the protective earth conductor
(the grounding conductor of the power
1 Ω.
(4) OK if <
plug) during normal operation.
(4) Use a tester to measure the resistance
between the chamber frame and the
grounding terminal.
6-6
Inspection item Inspection method Criteria Note
backup.
8. Electric tests (1) Short circuit breaker operation.
(2) Battery capacity for power failure
(3) Leakage current.
grounding.
(4) Conditions of the equipment with
) when filling is
2
Inspection item Inspection method Criteria Note
tubes. Exchange the tube with leakage.
9. Other items to inspect
(1) Bending, leakage, staining, etc. of (1) Visual inspection. (1) OK if the equipment functions normally.
DIALYSIS, RINSING) present.
(2) Abnormal sound/smell. (STANDBY, (2) Check sounds and smells. (2) OK if no abnormal sounds/smell are
hydraulic line. process.
(3) Presence of air bubbles in the (3) Visual inspection during the standby (3) No air bubbles in the hydraulic line
(4) Leakage from the hydraulic line. (4) Perform the start-up test or the CHECK (4) Test must be completed without a
operation from MAINTE7. problem.
(5) Filling flow rate. (5) In the standby process, measure the (5) Drainage flow rate must be 660 to (5) The system should not complete
drainage flow rate after installing the 680 mL/min. filling within 40 sec.
flow gauge onto the drainage line. Only a standard specification.
(Drainage flow rate: 500 mL/min)
(6) Filling complete pressure. (6) Measure the pressure on the P4- (6) The pressure must be 0.093 to 0.098 (6) Only a standard specification.
discharge side. (FS1-OUT side) Mpa (0.95 to 1.0 kgf/cm
complete.
(7) Dialysate flow rate. (7) Measure the MAX dialysate flow rate. (7) The MAX dialysat flow must be (7) Only a standard specification.
700 mL/min.
(8) Tightening the terminal block. (8) Check the tightening. (8) OK if not loose. (8) The power breaker must be turned
OFF.
6-7
) when filling
2
6-8
Inspection item Inspection method Criteria Note
tubes. Exchange the tube with leakage.
10. Powder Bicarbonate Assy (Option)
(1) Movement of the solenoid valve. (1) Check the movement from MAINTE4. (1) Must have the movement sound
(2) Bending, leakage, staining, etc. of (2) Visual inspection. (2) OK if the equipment functions normally.
with functions.
(3) Damage/deformation that interfere (3) Visual inspection. (3) Must not be damaged/deformed
(4) Stain, leakage, or blockage in filters. (4) Visual inspection. (4) Must have no stain, leakage, or
and hi flow Assy (Optional)
blockage
11. Variable control of dialysate flow Assy
(1) Filling flow rate. (1) In the standby process, measure the (1) Drainage flow rate must be 890 to (1) The system should not complete
drainage flow rate after installing the 950 mL/min. filling less than 32 sec.
flow gauge onto the drainage line.
(Drainage flow rate: 500 mL/min)
(2) Filling complete pressure. (2) Measure the pressure on the P4- (2) The pressure must be 0.113 to 0.118
discharge side. (FS1-OUT side) Mpa (1.15 to 1.2 kgf/cm
is complete.
(3) Dialysate flow rate. (3) Measure the MAX level of the dialysate (3) The MAX level must be 800 mL/min.
flow rate.
7-1
7. Parts Replacement
7 Parts Replacement ······················································································7-1
7.1 List of parts to be maintained and replaced·················································7-3
7.2 Parts replacement during maintenance·······················································7-8
7.2.1 Water supply filter Assy (F1) ································································7-8
7.2.2 Two-way solenoid valve (V1,V4,V5a,V5b,V6a,V6b,V7a,V7b,V8a
V8b,V9a,V9b,V10,V11,V19,V21)·················7-9
7.2.3 Two-way solenoid valve (V12) ·····························································7-10
7.2.4 Temperature sensor Assy (T) ·······························································7-11
7.2.5 Dialysate pressure sensor Assy (PD)···················································7-12
7.2.6 Conductivity sensor Assy (CD)·····························································7-13
7.2.7 Degassing tank Assy (AS1)··································································7-14
7.2.8 Air elimination tank Assy (AS2) ····························································7-15
7.2.9 Buffer tank Assy····················································································7-17
7.2.10 Magnet gear pump (P1/P2)··································································7-19
7.2.11 Heparin pump Assy (HP)······································································7-23
7.2.12 Blood pump Assy (BP) ·········································································7-26
7.2.13 Sample port Assy (SL)··········································································7-27
7.2.14 Rinse port ·····························································································7-28
7.2.15 Joint of concentrate tank ······································································7-30
7.2.16 Flow sensor Assy (FS1) ·······································································7-32
7.2.17 Flow sensor Assy (FS2/FS4)································································7-33
7.2.18 Coupler Assy ························································································7-34
7.2.19 Blood leak detector Assy (BLD) ···························································7-35
7.2.20 Chamber Assy (Ca/Cb) ········································································7-36
7.2.21 Ultrafiltration pump Assy (UFP)····························································7-37
7.2.22 Pump for A concentrate Assy (P3) ·······················································7-39
7.2.23 Pump for B concentrate Assy (P4) ·······················································7-41
7.2.24 Relief valve Assy (RV)··········································································7-43
7.2.25 Clamp Assy (CLV) ················································································7-44
7.2.26 Other hydraulic components ································································7-46
7.3 Miscellaneous part·······················································································7-47
7.3.1 Air filter··································································································7-47
7.3.2 Air filter 2 ······························································································7-48
7.4 Powder Bicarbonate Assy (option) ······························································7-49
7.4.1 Powder Bicarbonate Cartridge Holder Assy·········································7-49
7.4.2 B powder concentrate air elimination tank Assy (AS3) ························7-51
7.4.3 Pump for B concentrate Assy (P4)·······················································7-52
7.5 Hot disinfection with citric acid Assy (option)···············································7-54
7.5.1 Two-way solenoid valve (V4,V9a,V9b,V11,V19,(V34),(V35))··············7-54
7.5.2 Two-way solenoid valve (V5b,V6a,V6b,V7b,V8a,V8b) ························7-55
7.5.3 Two-way solenoid valve (V5a,V7a)······················································7-56
7.5.4 Two-way solenoid valve (V10) ·····························································7-57
7.5.5 Relief solenoid valve ((V33)) ································································7-58
7.5.6 Conductivity sensor Assy (CD)·····························································7-59
7.5.7 Degassing tank Assy (AS1)··································································7-60
7.5.8 Air elimination tank Assy (AS2) ····························································7-61
7.5.9 Buffer tank Assy····················································································7-63
7.5.10 Magnet gear pump (P1/P2)··································································7-65
7.5.11 Sample port Assy (SL)··········································································7-69
7.5.12 Rinse port ·····························································································7-70
7.5.13 Joint of concentrate tank ······································································7-71
7.5.14 Chamber Assy (Ca/Cb) ········································································7-72
7-2
7.5.15 Ultrafiltration pump Assy (UFP)····························································7-74
7.5.16 Pump for A concentrate Assy (P3) ·······················································7-76
7.5.17 Pump for B concentrate Assy (P4) ·······················································7-78
7.5.18 Relief valve Assy (RV)··········································································7-79
7.5.19 Other hydraulic components ································································7-80
7.5.20 Air filter 3 ······························································································7-81
Loading...