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Surdial: Operation Manual
Surdial: Operation Manual
SURDIAL
Manufacturer
NIPRO CORPORATION
3-9-3, Honjo-Nishi, Kita-Ku, OSAKA
531-8510, JAPAN
PHONE +81-6-6372-2331
Version No.0R1121-0801
The Operation Manual is intended to be prepared for correct and safe use of the machine
and not to be intended for description how to manage patient medically.
Be familiar with features of the machine and instructions how to operate it contained in this
manual before use.
PREFACE
11-1 11.1.2.Cleaning and After long term use of dialysate concentrate After long term use of dialysate concentrate
disinfection of dialysate connectors and rinse ports, solutes in the connectors and rinse ports, solutes in the
concentrate connectors concentrates may isolated to form harmful concentrates may isolated to form harmful
and rinse ports crystals and may cause the machine failure. crystals and may cause the machine failure.
※ Delete cleaning procedure Clean them using cloth wetted with tepid water Clean them using cloth wetted with alcohol or
using alcohol. or water regularly. Pull out the ports to this water regularly. Pull out the ports to this side to
side to allow easy cleaning. allow easy cleaning.
21-3 21.2.1.Dialysate flow UFR is ≦ 2.70L/h when dialysate flow rate is UFR is ≦ 4.00L/h when dialysate flow rate is
300mL/min. 30L/min.
0R1A01-0105
CONTENTS-1
CONTENTS-2
CONTENTS-3
CONTENTS-4
14.3.1. Connection of concentrates when acid rinse port (option) is not used ・・・・・・・・・・・14-3
14.3.1.1. Connection at water rinse ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-3
14.3.1.2. Connection at disinfection/rinse ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-3
14.3.1.3. Connection at acid rinse・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-3
14.3.2. Connection of concentrates when acid port unit (option) is used ・・・・・・・・・・・・・・・・・14-4
14.3.2.1. Connection at water rinse ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-4
14.3.2.2. Connection at disinfection/rinse ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-4
14.3.2.3. Connection at acid rinse・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-4
14.3.2.4. Connection at auto rinse 1 or 2 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-4
CONTENTS-5
CONTENTS-6
CONTENTS-7
CONTENTS-8
CONTENTS-9
CONTENTS-10
(1) Messages with symbol for safety are classified into the following
three categories:
DANGER
Cases critically causing death or severe injury of user by
misuse of the machine
WARNING
Cases potentially causing death or severe injury of user by
misuse of the machine
CAUTION
Cases potentially causing injury of user and/or loss of property
by misuse of the machine
(2) NOTE
Reference to operation of the machine
CAUTION-1
■ Before use of the machine, read and full understand this Operation Manual.
• The machine can be used safely and reliably when operated and
maintained as specified in the manual.
• Before operating the machine, read and full understand the manual to
avoid human injury and the machine damage.
• The machine shall be operated by well trained and qualified person only
unless otherwise instructed formally.
DO NOT touch any board, wiring and terminal with hand in all the cases
other than maintenance mode.
CAUTION-2
• Manage and instruct for the devices not to be brought in and not to be
used in hospital to prevent trouble occurrence.
• Keep power cord away from floor to avoid electric shock if short-circuit is
caused by water leak.
Read the manual before starting check and maintenance of the machine.
• Read and full understand the manual before starting check and
maintenance.
CAUTION-3
■ DO NOT apply hot rinse without hot rinse option. It might cause breakdown
of the machine.
CAUTION-4
■ Before starting the machine installation, read and full understand the
instructions specified in “6. INSTALLATION" of this Operation Manual.
• The machine shall be installed by well trained and qualified person only.
■ Before connecting any optional device to the machine, read and full
understand “Handling Manual” of the device.
• Take care not to give shock or impact to display and operation panel
during cleaning.
• If the machine is used after long term of storage, rinse using water for one
hour or longer.
• If the machine is used after long term of storage without removing water,
rinse well until dirty water is not drained.
■ There are the cases that display and process do not respond to operation of
some SW’s under certain conditions. DO NOT operate the SW’s forcibly.
■ Use the color coded dialysate concentrate container. Non- color coded one
is not applicable to the machine.
■ Gap between rollers and housing of blood pump can be adjusted within
allowable range. The adjustment may be required according to size of
rolling tube.
CAUTION-5
APPLICATION
1-1
CONTRAINDICATION
2-1
CAUTIONS
3-1
3-2
DEFINITION
4-1
4-2
4-3
Dialysate mixing
As shown in the below Fig., water is supplied to the right side of the viscous chamber.
By upward movement of piston of the viscous pump during temporally stop of the water
supply, A concentrate (for bicarbonate dialysis) of a volume corresponding to the piston
stroke is aspirated in the right side. By changing the piston stroke, dialysate
concentration can be changed. During the supply and aspiration, used dialysate is
drained from the left side.
UF control
As shown in the below Fig., fresh dialysate prepared in the right side is transferred to
the left side through dialyzer by operating the pump. By upward movement of piston of
the viscous pump, capacity of closed circuit (shown as bold lines) is increased,
generating negative pressure in dialysate compartment of the dialyzer. As the result,
fluid of a volume corresponding to the piston movement is removed from blood. By
changing the piston stroke, it is possible to change UF.
The system is build up so that dialysate preparation and UF control cycle is alternating,
which means that two sets are provided in the system.
4-4
5-1
INSTALLATION
Environmental condition and methods of unpacking, assembling, connection and wiring required to
install the machine and methods of disposal of used machine and packaging materials are specified
below. These operations should be performed by trained and qualified person(s) only.
The following requirements should be fulfilled to assure safe and effective use of the machine.
During :
Storage for one month
Transport
Use Daily storage or more; and Transport
without fluid
with contained fluid
Temp. (°C) 15 to 35 10 to 40 5 to 50 -10 to 50
Relative humidity 35 to 80 15 to 85 15 to 85 15 to 85
(%) No condensing
Atmospheric 795 to
795 to 1062 795 to 1062 700 to 1062
pressure (hPa) 1062
NOTE
Avoid direct exposure of the machine to sunlight
6-1
Space above the top of the machine should be ≧ 5 cm, that at each of right and left sides
should be ≧ 10 cm and that at rear side should be ≧ 20 cm.
A ventilation port with a diameter ≧ 20 cm should be provided or any side other than bottom
should be cleared so that the side is completely exposed to atmosphere.
Water supply and drainage conditions should be checked for normal operation of the machine.
Temperature : 17 to 30 °C.
The temperature should be lower than the set dialysate temperature by ≧ 5 °C.
If heat exchanger is used, the temperature should be 5-30 °C which should be lower than the
set dialysate temperature by ≧ 5 °C.
Supply water must be filtered through a 25 µm filter and the quality must be soft. The quality
must be monitored by regular analysis to maintain the acceptable quality.
WARNING
Use water of quality meeting AAMI - approved American National Standard for
Haemodialysis System, RD5, 1981, Section 3.2.
Otherwise, patient may suffer from seriously adverse effects.
6-2
Pressure :
Min : -100 mmHg (136 cm below inlet)
Max : +100 mmHg (136 cm above inlet)
6.1.4.6. Drainage
6-3
WARNING
Unpacking should be performed by at least 2 operators. Otherwise bone fracture may be
caused by drop of the machine on body.
NOTE
Tightening components such as screws and nuts are mm size. If missed, use those of the
same mm size.
(1) Just after unpacking, check conformance of manufacturing No. indicated on the package to
that on the machine.
(2) Check whether the following accessories are provided and whether the machine and
accessories are not damaged.
6-4
Fig.6-1 Accessories
6-5
6.3.1. Cautions
Attach the pole to the machine as shown in Fig. 6-2. Harness can be easily passed through the pole
by binding strand to the machine side connector followed by passing the connector bound strand
through the pole. Engage the connector with the lamp side connector securely.
Wires of the both connectors are colored as shown in the below Table:
Machine side (Letters on tube) Lamp side
Black or white (LAMP) Black or white
Red Red
6-6
Drill concentrate container cap to prepare hole as shown in the below Fig. 6-3.
Then cut off suction port by a depth suitable for the container to make notch as shown in the
below Fig. 6-4.
Cut off
Suction port
NOTE
If the container is provided with 2 ports closed with respective caps, engage the
connector with one of the ports and loosen the cap of the other port to allow air
introduction.
If the container is provided with only one port closed by one cap, engage the connector
with the port and loosen the cap to allow air introduction.
The caps (L and S) are not provided with the machine. Use L or S cap of the containers.
Prepare 3 or 4 connectors for containers receiving A, B and disinfectant concentrates;
and for container receiving acetic acid concentrate as option.
6-7
6.4.1. Connections of fluid supply and drain lines, coupler and power plug
CAUTION
Before and after tube and plug connection, check whether installation environment
conforms to the requirements specified in 6.1.1 of this operation manual.
Connect dialysate coupler tubes to ports “To dialyzer” and “From dialyzer” securely by
full advancing the tubes followed by banding them.
(1) Connect tube at blue band side of coupler to dialysate port “To dialyzer” securely by full
advancing the tube followed by banding.
(2) Connect tube at red band side of coupler to dialysate port “From dialyzer” securely by full
advancing the tube followed by banding.
(3) Cut red band any position. Connect CL filter to cutting point followed by banding.
Connect the side of inject port for CL filter to the edge “From dialyzer”.
Use tube of an internal diameter of 8 mm and a length of 2 m or shorter to connect to the port.
Fix the connection securely by strapping with metal clip.
CAUTION
By change of height of the tube free end from drain port placed at floor, dialysate
conductivity may be changed due to change of drain pressure. If the height is changed,
check the conductivity.
Insert power plug of the machine in receptacle securely by full advancing the plug.
6-8
(1) Load container of A concentrate (or acetate concentrate) and that of B concentrate on
respective container supports.
(2) Connect connectors of the machine for A and B concentrates to respective connectors of the
containers.
(3) Check whether connector of the machine for disinfectant concentrate is connected to rinse
port correctly.
(4) If acid rinse option is used, check whether connector for acetic acid concentrate is
connected to rinse port correctly.
CAUTION
Connect each concentrate connector, rinse port and the like securely. Otherwise, trouble
such as water leak or air aspiration may be caused.
During acetate dialysis (B concentrate is not used), connect connector for B concentrate
to corresponding rinse port placed at upper part of the machine.
CAUTION
Connect each concentrate connector, rinse port and the like securely. Otherwise, trouble
such as water leak or air aspiration may be caused.
Connect all 3 connectors of the machine for A, B and disinfectant concentrates to
respective rinse ports. If acid rinse option is used, connect acetic acid concentrate
connector to corresponding rinse port.
(1) Connect connector placed at rear side of the machine for disinfectant concentrate to
container for disinfectant concentrate.
(2) Check whether connectors of the machine for A and B concentrates are connected to
respective rinse ports securely.
(3) If acid rinse option is used, check whether connector for acetic acid concentrate is
connected to rinse port correctly.
CAUTION
Connect each concentrate connector, rinse port and the like securely. Otherwise, trouble
such as water leak or air aspiration may be caused.
6-9
(1) Connect connector placed at rear side of the machine for disinfectant concentrate to
container for acetic acid concentrate.
(2) Check whether connectors of the machine for A and B concentrates are connected to
respective rinse ports securely.
CAUTION
Connect each concentrate connector and the like securely. Otherwise, trouble such as
water leak or air aspiration may be caused.
6.4.2.5. Connection for acetic acid rinsing (when acid rinse option is used)
(1) Connect connector placed at rear side of the machine for acetic acid concentrate to
container for the concentrate.
(2) Check whether 3 connectors for A, B and disinfectant concentrates are connected to
respective rinse ports securely.
CAUTION
Connect each concentrate connector and the like securely. Otherwise, trouble such as
fluid leak or air aspiration may be caused.
6.4.2.6. Connection for automatic rinsing (1 or 2) (when acid rinse option is used)
(1) Connect connector placed at rear side of the machine for disinfectant concentrate to
container for the concentrate.
(2) Connect connector placed at rear side of the machine for acetic acid concentrate to
container for the concentrate.
(3) Check whether connectors of the machine for A and B concentrates are connected to
respective rinse ports securely.
CAUTION
Connect each concentrate connector, rinse port and the like securely. Otherwise, trouble
such as water leak or air aspiration may be caused.
Use disinfectant and acetic acid concentrates of specified concentrations.
6-10
The machine is shipped after filling fluid line with air. To install the machine, remove air in
accordance with the procedures shown in message screen of display. The air is removed
automatically within 7 to 10 minutes.
CAUTION
Before starting air purge, check whether water supply is enabled. If disabled, pump may
be damaged due to unloaded operation.
NOTE
When the machine is turned on after long term, date and time may be initialized and E50
RAM INITIALIZE error may be occurred to initialize SETTING 1 screen. Because RAM
back up battery is emptied. The check and re-input should be performed by well trained
person.
RAM back up battery is rechargeable. It is full charged by power on the machine about 22
hours continuously. It is emptied by turn off the machine about 7 - 10 days.
(1) Check whether all connectors are connected to respective rinse ports correctly.
(2) Check whether water can be supplied.
(3) The air purge process is enabled during rinse wait mode only. Select the mode.
(4) Press [F・5] SW to display maintenance mode menu.
(5) Press [F・3] or [F・4] SW to select "MODE9” followed by pressing [F・1] SW.
[MAINTE MENU(4/5)]
MODE9:MACHINE FILLING PROCEDURE
MODE10:ALARM HISTORY
MODE9 MODE10 P.UP P.DOWN DISP.
(6) After checking display of [MAINTE 9], press [F・1] SW to start the air purge process.
[MAINTE 9]
GO TO RINSE WAITING MODE
PRESS START SW TO FILL MACHINE
START MENU
(7) To terminate the process forcibly during its execution, press [F・1] SW.
[MAINTE 9]
FILLING
STOP
[MAINTE 9]
END OF FILLING
MENU
6-11
Dispose used packaging materials after separating to groups of wood, styrol foam, corrugated
board and the like.
Dispose used blood lines and dialyzer by suitable manners specified by hospital or medical
facilities to prevent risk of infection.
6-12
(9) Clamp
Main
l
Operation
l
Blood line setting
l
8-1
8-2
8 Dialysate supply tube Tube used to supply fresh dialysate to port “To
Dialyzer”
9 Dialysate return coupler Coupler used to connect used dialysate return tube to
dialyzer
10 Dialysate supply coupler Coupler used to connect fresh dialysate supply tube to
dialyzer
11 Bypass connector Connector used to bypass ports “From Dialyzer” and
“To Dialyzer” when couplers Nos. 9 and 10 are set to
the machine during rinsing operation
12 Limit SW for bypass SW used to detect whether coupler is received in
connector coupler holder
13 Coupler holder Holder used to receive coupler during rinsing operation
14 Dialysate flow rate Valve used to regulate dialysate flow rate in closed
regulating needle valve circuit
15 Container support Support used to load dialysate concentrate container
16 Port “From Dialyzer” Port used to return used dialysate from dialyzer
8-3
18 Water supply port Port used to connect hose for supplying purified water
to the machine
19 Drain port Port used to connect hose for draining used dialysate
23 Priming flow rate regulating Valve used to regulate flow rate of priming solution
needle valve
24 Tray Tray used to hold tools during dialysis by placing it on
the machine top
8-4
8-5
6 [RINSE] SW with lamp SW used to start rinsing of fluid lines of the machine
“During rinsing” is indicated by lamp lighting.
7 CONDITION lamp Lamp used to indicate operating condition
“During UF” is indicated by green lighting and “during
alarm actuation” is indicated by red lighting.
8 [MUTE] SW with lamp “Alarm actuation” is indicated by lamp lighting. By
pressing SW, buzzing is muted and lamp is OFF.
9 [RESET] SW with lamp “Alarm actuation” is indicated by lamp lighting. By
pressing SW after muting buzzer, alarm is released and
lamp is OFF.
10 POWER lamp “Power SW ON” is indicated by lamp lighting.
8-6
20 Set upper DP/AP limit SW used to increase set upper DP or AP limit within
increasing SW acceptable range
21 Set upper DP/AP limit SW used to decrease set upper DP or AP limit within
decreasing SW acceptable range
22 Set lower DP/AP limit SW used to increase set lower DP or AP limit within
increasing SW acceptable range
23 Set lower DP/AP limit SW used to decrease set lower DP or AP limit within
decreasing SW acceptable range
24 Conductivity indicator Indicator used to show conductivity by bar graph
Upper and lower limits of set conductivity range are
also shown by different colors.
25 Total UF volume indicating LED used to indicate total UF volume at this time
LED digitally
26 [UF RESET] SW SW used to reset total UF volume indicating LED
33 Left time indicating LED LED used to indicate left dialysis time at this time
digitally
8-7
34 Set left time increasing SW SW used to increase displayed left dialysis time
digitally
35 Set left time decreasing SW SW used to decrease displayed left dialysis time
digitally
36 FUNCTION 1 SW SW used to set various parameters
Set data is indicated in message screen.
37 FUNCTION 2 SW SW used to set various parameters
Set data is indicated in message screen.
38 FUNCTION 3 SW SW used to set various parameters
Set data is indicated in message screen.
39 FUNCTION 4 SW SW used to set various parameters
Set data is indicated in message screen.
40 FUNCTION 5 SW SW used to set various parameters
Set data is indicated in message screen.
41 Bubble sensor activating SW use to activate bubble sensor
SW with lamp Sensor activation is indicated by lamp lighting.
42 Syringe pump fast infusion SW use to operate syringe pump at fast infusion rate
SW
43 Syringe pump flow rate LED used to indicate flow rate of syringe pump digitally
indicating LED
44 Set syringe pump flow rate SW used to increase set syringe pump flow rate
increasing SW
45 Set syringe pump flow rate SW used to decrease set syringe pump flow rate
decreasing SW
46 Syringe pump operating SW used to operate syringe pump
SW with lamp Pump operation is indicated by lamp lighting.
47 Blood pump flow rate LED used to indicate BP flow rate digitally
indicating LED
48 Blood pump flow rate Volume used to set BP flow rate
setting
volume
49 Blood pump operating SW SW used to operate blood pump
with lamp Pump operation is indicated by lamp lighting.
8-8
8-9
1 Blood pump rotor Rollers used to deliver blood by squeezing blood line
tube
5 Clamp Clamp used to close blood line tube for blood flow stop
7 Venous pressure inlet port Port used to introduce venous pressure for its
measurement
8-10
8-11
8 Air filter Filter used to remove dust from air introduced into
Electrical POWER BOX.
8-12
8-13
8-14
DISPLAY
LCD is used to display various dialysis related information and parameter setting screens in
area of 40 letters×4 lines.
Many information and parameter setting screens are available. Desired mode screen can be
displayed by SW operation on operation panel.
[F 5] SW (DISP.)
・ ・
・
(MODE
・
* )
9-1
9-2
Areas from①to⑨are allocated to LCD screen to display information specified for each of
them.
① ② ③
⑤ ⑥ ⑦ ⑧ ⑨
9-3
9-4
9-5
INDICATION DESCRIPTION
CAUTION
z Any specifications and functions may not be provided according to the machine version
No. To know the details, contact our branch or representative near your place.
9-6
[RINSE MENU]
RINSE1:WATER RINSE3:AUTO1 C&D
RINSE2:CHEMICAL RINSE4:AUTO2 C&D
RINSE1 RINSE2 RINSE3 RINSE4 DISP.
INDICATION DESCRIPTION
9-7
When rinse wait mode is selected, rinse mode and time to be executed are displayed.
Information displayed together with the mode and time is defined by selected rinse mode.
+ - MENU
9.3.2.2 RINSE2:CHEMICAL
+ - MENU
Press [F・3] or [F・4] SW to shift blink to desired position and press [F・1] or [F・2] SW to
change setting.
Details are same as the case of『RINSE4:AUTO2 C&D』.
9-8
Press [F・3] or [F・4] SW to shift blink to desired position and press [F・1] or [F・2] SW to
change setting.
Rinse program and time can be changed.
INDICATION DESCRIPTION
WTR※※ Execution of water rinse for ※※ min
CHM※※ Execution of disinfection/rinse for ※※ min
ACD※※ Execution of acid rinse for ※※ min
DWL※※ Execution of dwelling for ※※ min
PRE※※ Start of prerinse at time set by PRERINSE START
----- No operation
PRERINSE START Setting of prerinse start time within period from this
time to 6 days after it
NOTE
z If acid rinse port unit (option) is not set to the machine, simultaneous setting of both
disinfection/rinse and acid rinse is disabled.
z If program adversely affecting the machine operation; for example, program to execute
disinfection/rinse and acid rinse in sequence; or that including no prerinse or no water
rinse step after rinse completion is set, rinsing operation can not be started even by
pressing RINSE SW.
z Refer to the option manual for setting hot rinse function. Set up hot water rinse (HWR)
and hot chemical disinfectant rinse require the machine already have hot rinse option.
9-9
DISP.
DISP.
9-10
9-11
DISP.
9.3.4.2 RINSE2:CHEMICAL
Rinse time of 00 min is displayed to indicate fluid line function stop.
DISP.
9-12
9.4.1 Dialysis
Part of dialysis related information is displayed during dialysis wait, preparation, preparation
end, dialysis and recovery processes.
[DIALYSIS]
VP: 140mmHg DP: 100mmHg COND:14.0mS/cm
AP:-100mmHg TMP: 40mmHg TEMP:37.0゜C
S.N. SQHD PRIM TEST DISP.
INDICATION DESCRIPTION
NOTE
z Select this screen during dialysis.
z Also refer to information found on operation panel.
z Information not found in this screen is shown in maintenance mode 1 screen.
9-13
Press [F・1] or [F・2] SW to change target priming volume. Press [F・4] SW to release from
priming mode.
Press [F・5] SW to display settingⅠscreen.
[PRIMING]
SOLUTION VOL.(l):5.00
ACCUMULATED VOL.(l):5.00 RATIO(%):100
+ - EXIT DISP.
INDICATION DESCRIPTION
9-14
[TEST]
BP:OK CLV:OK BD: VPa: VPb:
VP: AP:
EXIT DISP.
INDICATION DESCRIPTION
NOTE
z The self diagnosis is simple. Accordingly, all required checks can not be performed.
z The diagnosis is performed under specified conditions. If the conditions are not satisfied,
NG may be resulted.
9-15
Press [F・3] or [F・4] SW to shift blink to desired position and press [F・1]or [F・2] SW to
change setting.
The setting change is enabled at any time required.
Press [F・5] SW to display settingⅡscreen.
[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.
INDICATION DESCRIPTION
NOTE
z Settings not found in this screen are shown in settingⅡscreen and maintenance mode 2,
5, 6 and 7 screens.
9-16
Press [F・3] or [F・4] SW to shift blink to desired position and press [F・1]or [F・2] SW to
change setting.
The setting change is enabled at any time required.
Press [F・5] SW to display maintenance mode menu.
[SETTING2]
1.BC(W+A+B) :140 2.BC(W+A) :110
3.AC(W+AC) :140 4.MODE :BC1
+ - < > DISP.
INDICATION DESCRIPTION
NOTE
z Settings not found in this screen are shown in settingⅡscreen and maintenance mode 2,
5, 6 and 7 screens.
9-17
Press [F・3] or [F・4] SW to changeover screen and press [F・1] or [F・2] SW to select desired
mode.
Press [F・5] SW to display rinse or dialysis screen. During alarm is actuated, the alarm
screen is displayed.
[MAINTE MENU(1/5)]
MODE1:DATA
MODE2:ALARM SETTING
MODE1 MODE2 P.UP P.DOWN DISP.
9-18
[ERROR](10)
1.E24 AIR BUBBLE ARE DETECTED
2.E26 SHORT WATER SUPPLY
UP DOWN DISP.
9-19
When any error is detected by the machine, it is alerted by lighting of condition and main
lamps with buzzing and the alarm related message is displayed in relevant screen. According
to severity of the alarm, corrective functions such as the machine stop is executed
automatically by safety system contained in the machine.
WARNING
z If any error is alerted repeatedly, stop the machine to discontinue dialysis immediately
and disconnect patient from the machine. Otherwise, the patient may suffer from serious
injury.
10-1
10-2
10-3
10-4
BP
Alarm Detection Detection Fluid line CLV Alarm
Alarm name Audible alarm SP Resetting and note
No. condition process function close release
stop
E01 RECOVER FROM Return to normal after •Rinse ○(3 times) Execution of ― ― ― Automatic return to normal
EMERGENCY STOP power failure caused •Preparation sequence before Becoming error free of set upper and lower
during sequence •Preparation end error detection VP/ AP/ DP alarm limits by alarm actuation
execution •Dialysis
•Recovery
E02 T1 TEMPERATURE T1 temperature exceeding •Rinse wait •○(7 times) •Continuance ― ― ○ Return to normal by pressing [RESET] SW
SENSOR ERROR measurable temperature •Rinse •Same as above •Same as above
•Rinse end •Same as above •Same as above
•Air purge •Same as above •Same as above
•Dialysis wait •○(Continuous) •Same as above
•Preparation •Same as above •Fluid line stop
•Preparation end •Same as above •Same as above
•Dialysis •Same as above •Same as above
•Recovery •Same as above •Same as above
E03 T2 TEMPERATURE T2 temperature exceeding •Rinse wait •○(7 times) •Continuance ― ― ○ Return to normal by pressing [RESET] SW
SENSOR ERROR measurable temperature •Rinse •Same as above •Same as above During rinse process, upper value of
•Rinse end •Same as above •Same as above measurable range could not be detected.
•Air purge •Same as above •Same as above
•Dialysis wait •○(Continuous) •Same as above
•Preparation •Same as above •Fluid line stop
•Preparation end •Same as above •Same as above
•Dialysis •Same as above •Same as above
•Recovery •Same as above •Same as above
E04 T3 TEMPERATURE T3 temperature exceeding •Rinse wait •○(7 times) •Continuance ― ― ○ [Return to normal by pressing [RESET] SW
SENSOR ERROR measurable temperature •Rinse •Same as above •Same as above
•Rinse end •Same as above •Same as above
•Air purge •Same as above •Same as above
•Dialysis wait •○(Continuous) •Same as above
•Preparation •Same as above •Fluid line stop
•Preparation end •Same as above •Same as above
•Dialysis •Same as above •Same as above
•Recovery •Same as above •Same as above
E05 DIALYSATE Dialysate temperature (T3) •Preparation ○(Continuous) Auto bypass ― ― ○ Return to normal by pressing [RESET] SW
TEMPERATURE of ≧ set upper alarm limit •Preparation end Heater OFF Auto reset after release from detection
MAX ALARM •Dialysis condition for 10 sec
•Recovery
10-4
10-5
10-6
10-7
10-8
10-9
10-10
10-11
10-12
10-13
10-14
• Take care that any fluid is not introduced into venous and arterial pressure inlet ports to
prevent their pressure sensor damage.
CAUTION
• DO NOT use disinfectant such as dilute NaClO solution because NaClO generates chlorine
by spontaneous decomposition. Chlorine is not only harmful to human body, but also
damages electric components, resulting the machine failure.
11-1
WARNING
z Disinfect dialysate line inside after each dialysis termination. If not disinfected for a long
time, the machine inside may be contaminated with proliferated microorganisms, which may
be introduced into patient body, threatening his/her life.
CAUTION
z If Na hypochlorite concentrate of concentration exceeding 6% is used, fluid line materials
may be damaged.
z If the concentrate is required to be diluted, use haemodialyis-quality water specified by
AAMI.
z DO NOT connect the concentrate to the machine for a long time. The concentration may be
reduced by evaporation of Na hypochlorite, causing insufficient disinfection performance.
WARNING
z If the diluted concentration is lower than 1000ppm and disinfection time is shorter than 50
minutes, sufficient disinfection performance can not be obtained. Therefore, fluid line inside
may be contaminated with proliferated microorganisms, which may be introduced into
patient body, threatening his/her life.
11-2
[MAINTE MENU(4/5)]
MODE7:SYSTEM
MODE8:SERVICE FREQUENCY
MODE7 MODE8 P.UP P.DOWN DISP.
[MAINTE 7]
4.DISINFECTION RATIO :1/300
5.ACID RATIO : 1/30
+ - UP DOWN MENU
WARNING
z If disinfectant remains in the machine even though the amount is small, patient life may
be threatened.
z Execute water rinse for 30 minute or more after disinfection. The time, however, is
changed according to diluted disinfectant concentration and dialysate flow rate. It is
recommended to check residual disinfectant amount using test paper or reagent.
11-3
Execute acid rinse in rinse mode to remove calcium deposit from fluid line inside.
WARNING
z When bicarbonate dialysate is used, calcium salt is deposited in fluid line inside. The
deposition may cause microbial proliferation and malfunction of the machine
components. Remove the deposit once or more weekly.
CAUTION
z If acetic acid concentrate of concentration exceeding 50% is used, fluid line materials
may be damaged.
z If the concentrate is required to be diluted, use haemodialysis-quality water specified by
AAMI.
z DO not connect the concentrate to the machine for a long time. The concentration may be
reduced by evaporation of acetic acid, causing insufficient calcium deposit removing
performance.
WARNING
z If diluted acetic acid concentration is lower than 1% and acid rinse time is shorter than 30
minutes, microbial proliferation and malfunction of the machine components may be
caused.
11-4
[MAINTE MENU(4/5)]
MODE7:SYSTEM
MODE8:SERVICE FREQUENCY
MODE7 MODE8 P.UP P.DOWN DISP.
[MAINTE 7]
5.ACID RATIO : 1/30
6.HOT DISINFECTION RATIO : 1/26
+ - UP DOWN MENU
WARNING
z If acetic acid remains in the machine even though the amount is small, patient life may be
threatened.
z Execute water rinse for 30 minute or more after acid rinse. The time, however, is changed
according to diluted acetic acid concentration and dialysate flow rate. It is recommended
to check residual acetic acid amount using test paper or reagent.
11-5
PROCESS FLOW
[DIALYSIS]SW_OFF
[FUNCTION]SW_ON
[DIALYSIS]SW_ON
透析待機工程
Dialysis wait 洗Rinse
浄待機工程wait エア抜き工程
Air purge
[PRIP.]SW_ON [RINSE]SW_ON
準備工程
Preparation 洗浄工程
Rinse
自動 洗浄終了
Preparation
準備完了工程 洗浄終了工程
Rinse end
end
[UF DIALYSE]SW_ON
透析工程
Dialysis
R回収工程
ecovery
12-1
NOTE
z To check leak from closed circuit, positive pressure is applied to the circuit by operating
viscous pump for finding whether fluid is leaked from the circuit. If the leak is detected,
“E36~E43 VC CLOSED CIRCUIT LEAK ERROR" is displayed to alert.
12-2
Even in “preparation end” process, if any of the above conditions is not satisfied, dialysate
flow is auto-bypassed or any alarm is actuated, shift to “dialysis” process is disabled unless
the condition is satisfied; or the bypassing or the alarm is corrected.
12-3
OPERATION OF MACHINE
13.1 Check and action before turning on power breaker
Before starting daily operation of the machine, check the following items specified in the
below Table and correct non-conformance immediately if detected.
WARNING
z If non-conformance can not be corrected, DO NOT operate the machine.
13-1
6 Cleaning
・ The machine enclosure should be cleaned. □ OK □NG
13-2
13-3
13.2.1 Machine SW ON
(1) Check correct connection of power plug to receptacle.
(2) Check no lighting of power lamp.
(3) Turn on power breaker placed at rear side of the machine.
z Power lamp is ON.
z Information is displayed on operation panel.
NOTE
z When recovery from power failure is notified, press [MUTE] SW and [RESET] SW to reset
the machine functions.
13.2.2 Prerinse
(1) Check ON of [DIALYSIS] SW lamp.
(2) Press [DIALYSIS] SW.
z [DIALYSIS] SW lamp is OFF.
z Rinse menu screen is displayed.
[RINSE MENU]
RINSE1:WATER RINSE3:AUTO1 C&D
RINSE2:CHEMICAL RINSE4:AUTO2 C&D
RINSE1 RINSE2 RINSE3 RINSE4 DISP.
CAUTION
z Rinse the machine before starting dialysis to prevent cross infection among patients.
13-4
[DIALYSIS]
VP: 0mmHg DP: 5mmHg COND: 0.0mS/cm
AP: 0mmHg TMP: -5mmHg TEMP:20.0゜C
S.N. SQHD PRIM TEST DISP.
13.2.4 Postrinse
(1) Check ON of [DIALYSIS] SW lamp.
(2) Press [DIALYSIS] SW.
z [DIALYSIS] SW lamp is OFF.
z Rinse menu screen is displayed.
[RINSE MENU]
RINSE1:WATER RINSE3:AUTO1 C&D
RINSE2:CHEMICAL RINSE4:AUTO2 C&D
RINSE1 RINSE2 RINSE3 RINSE4 DISP.
CAUTION
z Rinse the machine after dialysis termination to prevent cross infection among patients,
z Rinse the machine after disconnection of patient from it.
NOTE
z The machine can be left under power breaker OFF until the next dialysis. It is
recommended, however, to turn off the breaker when the machine is not operated for long
time.
13-5
RINSING
1. Select rinsing mode.
2. Set rinsing pattern.
3. Connect concentrate line(s) to the machine.
4. Start rinsing operation.
5. Terminate rinsing operation.
6. Discontinue rinsing operation.
WARNING
z Execute rinsing operation before and after dialysis.
z To execute disinfection/rinse or acid rinse, read Chapter 11.
z Read optional manual before use of hot water rinse or hot chemical disinfectant rinse.
z Do not apply hot rinse without hot rinse option. It might cause breakdown of the machine.
14-1
[RINSE MENU]
RINSE1:WATER RINSE3:AUTO1 C&D
RINSE2:CHEMICAL RINSE4:AUTO2 C&D
RINSE1 RINSE2 RINSE3 RINSE4 DISP.
NOTE
z When RINSE1 or RINSE2 is selected, only rinsing time can be set.
z When acid rinse port unit (option) is not used, simultaneous setting of both
disinfection/rinsing and acid rinsing in RINSE3 or RINSE4 mode is disabled.
z Refer to the option manual for setting. Set up hot water rinse (HWR) and hot chemical
disinfectant rinse (HCM) already have hot rinse option.
14-2
CAUTION
z Connect each concentrate connector and rinse port securely. If not so, troubles such as
water leak and air aspiration may be caused.
z Concentrate type(s) and concentrate connector type(s) are defined by use or no use of
acid rinse port unit (option) and rinse mode to be executed. Take care of this when
connection is executed.
z Use disinfectant and acetic acid concentrates of specified concentrations.
14.3.1 Connection of concentrates when acid rinse port (option) is not used
WARNING
z When acid rinse port (option) is not used, aspiration port of disinfectant or acetic acid
concentrate can be used as connector of disinfectant concentrate container. Check
conformance of concentrate type to rinse mode to be executed.
14-3
WARNING
z When acid rinse port unit (option) is used, aspiration ports of disinfectant and acetic acid
concentrates can be used as connectors of concentrates to be used. Check conformance
of connector types to rinsing mode to be executed.
14-4
NOTE
z When rinsing pattern to execute disinfection/rinsing and acid rinsing in sequence is set
after selecting RINSE3 or RINSE4 mode, execution of the pattern is disabled even by
pressing [RINSE] SW.
z When rinsing pattern not to execute water rinse or prerinse next to other rinsing
operation is set after selecting RINSE3 or RINSE4 mode, execution of the pattern is
disabled even by pressing [RINSE] SW.
(2) Connect all concentrate connectors to respective rinse ports or engage them with
respective connector receivers.
(3) Check correct connector connection.
(4) Press [DIALYSIS] SW.
z[RINSE] SW is OFF.
z[DIALYSIS] SW lamp is ON.
zDialysis screen is displayed.
[DIALYSIS]
VP: 0mmHg DP: 5mmHg COND: 0.0mS/cm
AP: 0mmHg TMP: -5mmHg TEMP:20.0゜C
S.N. SQHD PRIM TEST DISP.
14-5
WARNING
z Rinsing can be discontinued at any step during the operation.
z DO NOT execute dialysis after rinsing is discontinued. Disinfectant or acid may be left in
the machine. Rinse the machine again to execute sialysis.
14-6
15-1
[SETTING2]
1.BC(W+A+B) :140 2.BC(W+A) :110
3.AC(W+AC) :140 4.MODE :BC1
+ - < > DISP.
WARNING
z Information concerning concentrate for each of BC1, BC2 and AC is found in
maintenance mode 5 screen. Set dialysis mode conforming to concentrate(s) intended to
be used.
z Both BC1 and BC2 are bicarbonate dialysis. Information not related to concentrate(s)
intended to be used may be shown in maintenance mode 5 screen. Take care of this.
[SETTING2]
1.BC(W+A+B) :140 2.BC(W+A) :110
3.AC(W+AC) :140 4.MODE :BC1
+ - < > DISP.
[SETTING2]
1.BC(W+A+B) :140 2.BC(W+A) :110
3.AC(W+AC) :140 4.MODE :BC1
+ - < > DISP.
[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.
15-3
CAUTION
z Connect each concentrate connector and rinse port securely to prevent troubles such as
water leak and air aspiration.
z Use A and B concentrates for preparing bicarbonate dialysate and acetic acid
concentrate for preparring acetate dialysate of specified concentrations.
15-4
15-5
When the set ratio is 200%, it moves at a half speed compared with the case that the ratio is
100% with the exception.
[MAINTE 7]
20.MAINTENANCE MODE FREE : OFF
UP DOWN MENU
[MAINTE 7]
20.MAINTENANCE MODE FREE : ON
+ - UP DOWN MENU
(4) Instruction appears in [F・1] or [F・2] SW (+/-). Check that setting is enabled by
blinking of items to be set.
(5) Press [F・3] or [F・4] SW to blink "1.SYRINGE RATE".
(6) Press [F・1] or [F・2] SW to change set value.
[MAINTE 7]
1.SYRINGE RATE : 100
2.BP STOP AFTER POWER FAIL : OFF
+ - UP DOWN MENU
By the setting, automatic syringe operation stop is enabled at a set time before UF
completion and the stop is indicated by error message "E61 COMPLETION OF SYRINGE.P
INFUSION".
[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.
15-6
[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.
[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.
z0.0 :Bolus infusion during pressing [F.F] SW only until reaching to maximum
infusion
as 5 mL. Return regular infusion automatically when bolus infusion is
reached to
maximum infusion.
z0.5-5.0 :Bolus infusion of set infusate volume
CAUTION
z Syringe pump may not stop infusing after releasing [F.F] SW by some switch
malfunction. In this case, stop syringe pump by turn OFF the breaker of the machine and
then interrupt treatment. Machine must be disconnected from patient.
15-7
15-9
CAUTION
z Follow instruction of dialyzer manufacturer to know “which should be preceded blood or
dialysate compartment when dialyzer is primed”.
z In the case of priming blood compartment, when “priming function” is used, follow
instruction specified in 15.6.4.1. If the function is not used, follow instruction specified in
15.6.4.2.
z Priming method may be specified by each hospital or medical facilities. Prime dialyzer
based on method specified by it unless function and performance of the machine is
damaged. The method described in this manual is example.
15-10
[PRIMING]
SOLUTION VOL.(l):5.00
ACCUMULATED VOL.(l):5.00 RATIO(%):100
+ - EXIT DISP.
(3) Press [F・1] or [F・2] SW to set "SOLUTION VOL.(l)" to suitable level so that small
amount of saline can be left in vial after priming completion.
(4) Check that "ACCUMULATED VOL.(l)" is 0.00.
(5) Check that "RATIO(%)" is 0.
(6) Set flow rate by operating flow rate adjusting volume of blood pump.
(7) Turn on [ON/OFF] SW of blood pump to operate it.
(8) Remove air from dialyzer.
(9) Adjust level in venous drip chamber.
・ Check that clamp of level adjusting line is closed.
・ Open cap of the line to connect syringe.
・ Remove clamp and adjust level in the chamber to desired height by pushing or
pulling syringe plunger.
・ Close clamp of the line.
(10) When priming with saline of target volume is completed, it is notified by buzzing and
[ON/OFF] SW of blood pump is turned off automatically to stop blood pump. Press
[MUTE] SW and [RESET] SW to mute buzzing and to erase alarm message respectively.
15-11
15-12
15-13
CAUTION
z The following method is example to connect patient to the machine when Nipro dry type
hollow fiber dialyzer and blood line are used. When other dialyzer and blood line are
used by any reason, follow instruction specified by the manufacturer.
(1) Connect arterial shunt joint line to arterial access line of AVF needle retained in patient
by inserting male Luer in female Luer followed by turning red locking Luer to engage
the both securely.
(2) Open clamp of the joint line together with that of the access line.
(3) Open clamp of venous shunt joint line.
(4) Open clamps of arterial and venous pressure monitor lines.
(5) Turn flow rate setting volume of blood pump to the left fully.
(6) Turn on [ON/OFF] SW of blood pump to operate it with flow rate indication.
(7) Set flow rate by operating flow rate setting volume of the pump.
(8) Stop the pump by turning off [ON/OFF] SW of it when blood is introduced in venous
drip chamber.
(9) Clamp venous shunt joint line.
(10) Disconnect recirculation connector from venous shunt joint line to discard.
(11) Connect venous shunt joint line to venous access line of AVF needle retained in patient.
(12) Remove clamp from venous shunt joint line under clamping venous access line of
patient.
(13) Tap venous shunt joint line lightly to shift bubble to inside of venous drip chamber.
(14) Open clamp of venous access line of patient.
(15) Turn flow rate setting volume of blood pump to the left fully.
(16) Turn on [ON/OFF]SW of blood pump to operate it with flow rate indication.
(17) Set flow rate by operating flow rate setting volume of blood pump.
(18) Open clamp of syringe infusion line.
(19) Turn on [ON/OFF] SW of syringe pump to operate it with flow rate indication.
(20) Set flow rate by pressing [△] or [▽] SW of syringe pump.
15-14
1. Start dialysis.
2. Set upper and lower venous pressure alarm limits.
3. Set upper and lower arterial pressure alarm limits.
4. Set upper and lower dialysate pressure alarm limits.
[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.
15-15
[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.
15-16
1. Check UF completion.
2. Start blood recovery.
3. Execute blood recovery.
4. Remove coupler.
5. Clear away.
6. Complete blood recovery.
15-17
15-18
CAUTION
z Execute post rinsing based on procedures specified in Chapter 14.
15-19
Discontinue UF.
Discontinue dialysis.
15.12.1. Discontinuance of UF
(1) Press [PREP.] SW once.
z[PREP.] SW lamp is ON.
z[UF DIALYSE] SW lamp is OFF.
zShift to recovery process is followed.
zFluid lines are functioning normally.
zUF is stopped.
CAUTION
z UF can be stopped by setting UFR to 0.00L/h.
z When [PREP.] SW is pressed to shift to recovery process and to disable UF, setting of all
pressure alarm limit is released. Set the limits manually if required.
z When [PREP.] SW is pressed to shift to recovery process and to disable UF , “MINIMUM
UF” function is disabled.
CAUTION
z When bypass mode is selected during dialysis, dialysate supply to dialyzer is stopped,
while UF continues.
z When bypass mode is selected during blood recovery process, dialysate supply to
dialyzer is stopped in addition to UF stop already executed.
15-20
16-1
[SETTING2]
1.BC(W+A+B) :140 2.BC(W+A) :110
3.AC(W+AC) :140 4.MODE :BC1
+ - < > DISP.
WARNING
z Information concerning concentrate for each of BC1, BC2 and AC is found in
maintenance mode 5 screen. Set dialysis mode conforming to concentrate(s) intended to
be used.
z Both BC1 and BC2 are bicarbonate dialysis. Information not related to concentrate(s)
intended to be used may be shown in maintenance mode 5 screen. Take care of this.
[SETTING2]
1.BC(W+A+B) :140 2.BC(W+A) :110
3.AC(W+AC) :140 4.MODE :BC1
+ - < > DISP.
[SETTING2]
1.BC(W+A+B) :140 2.BC(W+A) :110
3.AC(W+AC) :140 4.MODE :BC1
+ - < > DISP.
[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.
16-3
CAUTION
z Connect each concentrate connector and rinse port securely to prevent troubles such as
water leak and air aspiration.
z Use A and B concentrates for preparing bicarbonate dialysate and acetic acid concentrate
for preparing acetate dialysate of specified concentrations.
16-4
16-5
[MAINTE 7]
20.MAINTENANCE MODE FREE : OFF
UP DOWN MENU
[MAINTE 7]
20.MAINTENANCE MODE FREE : ON
+ - UP DOWN MENU
(4) Instruction appears in [F・1] or [F・2] SW (+/-). Check that setting is enabled by
blinking of items to be set.
(5) Press [F・3] or [F・4] SW to blink "1.SYRINGE RATE".
(6) Press [F・1] or [F・2] SW to change set value.
[MAINTE 7]
1.SYRINGE RATE : 100
2.BP STOP AFTER POWER FAIL : OFF
+ - UP DOWN MENU
16-6
[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.
[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.
z0.0 :Bolus infusion during pressing [F.F] SW only until reaching to maximum
infusion
as 5 mL. Return regular infusion automatically when bolus infusion is
reached to
maximum infusion.
z0.5-5.0 :Bolus infusion of set infusate volume
CAUTION
z Syringe pump may not stop infusing after releasing [F.F] SW by some malfunction.
In this case, stop syringe pump by turn OFF the breaker of the machine and then
interrupt
treatment. Machine must be disconnected from patient.
16-7
16-8
CAUTION
z Follow instruction of dialyzer manufacturer to know “which should be preceded blood or
dialysate compartment when dialyzer is primed”.
z In the case of priming blood compartment, when “priming function” is used, follow
instruction specified in 15.6.4.1. If the function is not used, follow instruction specified in
15.6.4.2.
z Priming method may be specified by each hospital or medical facilities. Prime dialyzer
based on method specified by it unless function and performance of the machine is
damaged. The method described in this manual is example.
16-9
[PRIMING]
SOLUTION VOL.(l):5.00
ACCUMULATED VOL.(l):5.00 RATIO(%):100
+ - EXIT DISP.
(3) Press [F・1] or [F・2] SW to set "SOLUTION VOL.(l)" to suitable level so that small
amount of saline can be left in vial after priming completion.
(4) Check that "ACCUMULATED VOL.(l)" is 0.00.
(5) Check that "RATIO(%)" is 0.
(6) Set flow rate by operating flow rate adjusting volume of blood pump.
(7) Turn on [ON/OFF] SW of blood pump to operate it.
(8) Remove air from dialyzer.
(9) Adjust level in venous drip chamber.
・ Check that clamp of level adjusting line is closed.
・ Open cap of the line to connect syringe.
・ Remove clamp and adjust level in the chamber to desired height by pushing or
pulling syringe plunger.
・ Close clamp of the line.
(10) When priming with saline of target volume is completed, it is notified by buzzing and
[ON/OFF] SW of blood pump is turned off automatically to stop blood pump. Press
[MUTE] SW and [RESET] SW to mute buzzing and to erase alarm message respectively.
16-10
16-11
16-12
CAUTION
z The following method is example to connect patient to the machine when Nipro dry type
hollow fiber dialyzer and blood line are used. When other dialyzer and blood line are used
by any reason, follow instruction specified by the manufacturer.
(1) Connect arterial shunt joint line to arterial access line of AVF needle retained in patient
by inserting male Luer in female Luer followed by turning red locking Luer to engage
the both securely.
(2) Open clamp of the joint line together with that of the access line.
(3) Open clamp of venous shunt joint line.
(4) Open clamps of arterial and venous pressure monitor lines.
(5) Turn flow rate setting volume of blood pump to the left fully.
(6) Turn on [ON/OFF] SW of blood pump to operate it with flow rate indication.
(7) Set flow rate by operating flow rate setting volume of the pump.
(8) Stop the pump by turning off [ON/OFF] SW of it when blood is introduced in venous
drip chamber.
(9) Clamp venous shunt joint line.
(10) Disconnect recirculation connector from venous shunt joint line to discard.
(11) Connect venous shunt joint line to venous access line of AVF needle retained in patient.
(12) Remove clamp from venous shunt joint line under clamping venous access line of
patient.
(13) Tap venous shunt joint line lightly to shift bubble to inside of venous drip chamber.
(14) Open clamp of venous access line of patient.
(15) Turn flow rate setting volume of blood pump to the left fully.
(16) Turn on [ON/OFF]SW of blood pump to operate it with flow rate indication.
(17) Set flow rate by operating flow rate setting volume of blood pump.
(18) Open clamp of syringe infusion line.
(19) Turn on [ON/OFF] SW of syringe pump to operate it with flow rate indication.
(20) Set flow rate by pressing [△] or [▽] SW of syringe pump.
16-13
[DIALYSIS] <SINGLE.N>
VP: 140mmHg DP: 100mmHg COND:14.0mS/cm
AP:-100mmHg TMP: 40mmHg TEMP:37.0゜C
S.N. SQHD PRIM TEST DISP.
NOTE
z By turning on single needle SW, changeover and alarm points are indicated in venous
pressure indicator. Inside point shows single needle changeover point and outside point
shows single needle alarm point.
z Press [UF DIALYSE] SW to start single needle dialysis.
NOTE
z By setting single needle changeover value, single needle alarm value is also set
automatically.
z If the changeover value is not set manually, the value is set automatically by pressing
[UF DIALYSE] SW.
16-14
1. Start dialysis.
2. Set upper and lower arterial pressure alarm limits (option).
3. Set upper and lower dialysate pressure alarm limits.
[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.
16-15
[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.
16-16
1. Check UF completion.
2. Start blood recovery.
3. Execute blood recovery.
4. Remove coupler.
5. Clear away.
6. Complete blood recovery.
16-17
16-18
CAUTION
z Execute post rinsing based on procedures specified in Chapter 14.
16-19
Discontinue UF.
Discontinue dialysis.
16.13.1. Discontinuance of UF
(1) Press [PREP.] SW once.
z[PREP.] SW lamp is ON.
z[UF DIALYSE] SW lamp is OFF.
zShift to recovery process is followed.
zFluid lines are functioning normally.
zUF is stopped.
CAUTION
z UF can be stopped by setting UFR to 0.00L/h.
z When [PREP.] SW is pressed to shift to recovery process and to disable UF, setting of all
pressure alarm limit is released. Set the limits manually if required.
z When [PREP.] SW is pressed to shift to recovery process and to disable UF , “MINIMUM
UF” function is disabled.
CAUTION
z When bypass mode is selected during dialysis, dialysate supply to dialyzer is stopped,
while UF continues.
z When bypass mode is selected during blood recovery process, dialysate supply to
dialyzer is stopped in addition to UF stop already executed.
16-20
SEQUENTIAL DIALYSIS
It is possible to execute UF only during double needle or single needle mode in dialysis
process by stopping dialysate flow to dialyzer.
By pressing [F・2] SW during dialysis screen is displayed, sequential dialysis (SQHD) is
started.
WARNING
z Basic procedures can be found in Chapters 15 and 16. Read them.
z If dialyzer is not primed with dialysate, sequential dialysis (SQHD) is disabled.
[DIALYSIS] < SQHD >
VP: 140mmHg DP: 100mmHg COND:14.0mS/cm
AP:-100mmHg TMP: 40mmHg TEMP:37.0゜C
S.N. SQHD PRIM TEST DISP.
NOTE
z By ON setting during dialysis, sequential dialysis is started immediately.
z When ON is set during any process other than dialysis previously, sequential dialysis is
started immediately after pressing [UF DAIALYSE] SW.
z Immediately after start of sequential dialysis, dialysate flow may not be stopped for
scores of seconds to several minutes to control timing of dialysate flow stop by the
machine. This is not failure of the machine.
[DIALYSIS]
VP: 140mmHg DP: 100mmHg COND:14.0mS/cm
AP:-100mmHg TMP: 40mmHg TEMP:37.0゜C
S.N. SQHD PRIM TEST DISP.
NOTE
z By OFF setting of sequential dialysis or ON setting of [PREP.]SW, sequential dialysis is
stopped.
z Immediately after stop of sequential dialysis, dialysate flow may be stopped for scores of
seconds to several minutes to control timing of dialysate flow start by the machine. This
17-1
17-2
WARNING
z During check and maintenance of the machine, DO NOT connect patient to it.
1. Check and maintenance before and after operation of the machine (at each dialysis)
2. Cleaning of enclosure of the machine (at each dialysis)
3. Disinfection and rinsing of fluid lines (at each dialysis)
4. Acetic acid rinsing of fluid lines (weekly)
18-1
[TEST]
BP:OK CLV:OK BD: VPa: VPb:
VP: AP:
EXIT DISP.
NOTE
z Self diagnosis is simple one and all checks are not necessarily be performed.
z Self diagnosis can be performed under specified conditions. If any of the conditions is
not satisfied, the result may be NG.
z Although the result is NG, audible alarm is not actuated. Check indication of NG in test
screen
z The following items are self diagnosed:
• BP(blood pump) : Rotation test
• CLV(clamp) : Clamp ON/OFF operation test
• BD(bubble detector) : Bubble detection test
• VPa(viscous pump A) : Rotation test
• VPb(viscous pump B) : Rotation test
• VP(venous pressure sensor): Test to check venous pressure = 0±8mmHg
• AP(arterial pressure sensor): Test to check arterial pressure = 0±8mmHg
WARNING
z Confirm disinfectant concentrate can be sucked surely and disinfection can be performed
regularly. Take the confirmation once a week. It is possible that third-party infection is
happened due to malfunction of electric valves.
18-2
CAUTION
z Disinfect fluid line inside before operating the machine to avoid infection.
18-3
Earth
earth
t i l
18-4
R1
R2 C1 V
R1=10kΩ
R2=1kΩ
C1=0.015uF
18-5
Fig. 18-4 Setup to check accuracy Fig. 18-5 Setup to check accuracy
18-6
NOTE
z Actual syringe infusion rate is defined by syringe ratio set in maintenance mode 7 screen.
Define the ratio according to syringe size used. To check accuracy of syringe pump
infusion rate, use the syringe of the defined ratio.
18-7
18-8
Cartridge can be
removed by loosing
18-9
Adjust the zero revision of blood leak detector when “6.BLD AUTO ZERO” value less
than
-150ppm in maintenance mode 1 screen during preparation process.
CAUTION
z Perform water rinse or disinfection before you calibrate it.
It caused of display error if you calibrate it even blood leak detector is dirty.
[MAINTE 1]
6.BLD AUTO ZERO : ―30
7.BLD SENS VALUE : ――――――
UP DOWN MENU
F・1 F・2 F・3 F・4 F・5
18-10
Blood line
血液回路
BP
WATER
電子ハカリ
Electronic balance
18-11
18-12
NOTE
z Check the accuracy at low temperature (in water rinse process) and at high temperature
(in preparation end process).
z Place calibrated thermometer at position near temperature sensor (within 50cm).
Thermometer
Temperature sensor
18-13
NOTE
z Place calibrated conductivity meter at position near conductivity cell (within 60cm).
Calibrated conductivity
t
18-14
① Cap
② Hose port
③ Packing
④ Filter
⑤ Body
18-15
Plunger
Assy Body
Diaphragm
Body
18-16
18-17
Diaphragm
Bod
Diaphragm
Remove diaphragm by inserting tool with thin tip in gap between body and diaphragm to
defoliate it slowly from the body under care for the body is not damaged.
18-18
18-19
18-20
Drive gear
Hang to magnet ring CAUTION
● Remove magnet ring slowly and gently.
Magnet ring may change shape if pull
rough.
Magnet
ring Tweezers
Fig. 18-21
(7) Remove magnet can ⑥ from drive gear⑨. Do not allow dust stick to magnet can.
(8) Remove rear bearing⑭, rear plate⑯, drive gear⑨, slave gear⑩, gear case⑪, flat pin⑫,
front plate⑮, front bearing⑬ in this order. Take care for each component not to be
damaged.
(9) Attach front bearing⑬, rear bearing⑭ to O-ring. Paint silicon grease to O-ring before
attachment.
(10) Attach flat bearing⑫ to front bearing⑬. Assemble front plate⑮, gear case⑪, drive gear
⑨,
slave gear⑩, rear plate⑯, rear bearing⑭ in this order. Take care for each component is
fixed
hole position.
Insert direction of drive gear⑨ and slave gear⑩ as shown in Fig.18-22.
Drive gear⑨
To front To rear
bearing bearing
Slave Gear⑩
Fig. 18-22
18-21
Tweezers CAUTION
● Magnet ring may come off if it is fixed
Shrink in advance loosely. Shrink it before insert.
Drive gear ● Insert magnet ring surely to ditch of drive
Magnet ring
gear.
Fig. 18-23
(13) Insert retinas spring for fixing ditch of rear bearing⑭. Attach rear casing⑤ tightly.
When rear
casing ⑤ attach, do not turn it.
(14) Put on gasket A⑲ to front bearing⑬ for fixing hole position. Attach bracket⑧ for fixing
two
ditch of both parts.
(15) Attach gasket A⑱ to front bearing⑬. Assemble pump head⑰ using small screws.
Confirm direction
Confirm
CAUTION
direction ● Check and adjust direction for gasket hole
⑱ and front bearing hole ⑬ straightly.
It causes of water leakage and malfunction
凸 part
凸 part if direction setting is failure.
凹 part 凹 part
Casing
18-22
Fixing order
CAUTION
● Screw part of front bearing may broke if
Pump head
irregular torque or only one side tightens
Small screw screw.
Fig. 18-24
18-24
STORAGE
1. Actions before storing machine
2. Environmental conditions required to store machine
3. Check and test before re-operation of machine
CAUTION
• DO NOT wipe the machine enclosure with disinfectant such as dilute NaClO solution.
Chlorine is generated by decomposition of NaClO. The gas is not only harmful for human
but also damages electric components significantly, resulting in failure of the machine.
• Clean and disinfect arterial and venous pressure inlet ports carefully to avoid cross
contamination among patients.
19-1
Storage without
Daily storage Storage for ≧1 month
fluid
Ambient temp.(°C) 10 - 40 5 - 50 -10 - 50
Relative humidity 15 - 85 15 - 85 15 - 85
(%) No condensing
Atmospheric pressure 795 - 1062 795 - 1062 795 - 1062
(hPa)
CAUTION
• The check and test should be performed by well trained engineer having
knowledge how to maintain the machine. If incorrectly handled, troubles
such as fire and malfunction of the machine may be caused and abnormal
operation may be experienced in the next time use.
NOTE
• When the machine is turned on after long term, date and time may be initialized and
E50 RAM INITIALIZE error may be occurred to initialize SETTING 1 screen.
Because RAM back up battery is emptied. The check and re-input should be
performed by well trained person.
• RAM back up battery is rechargeable. It is full charged by power on the machine
about 22 hours continuously. It is emptied by turn off the machine about 7 - 10 days.
(1) When the machine is used after long term of storage, perform disinfection and water
rinsing in sequence each for one hour or longer.
(2) Check no water leakage; abnormal sound and nasty smell; and abnormal indication
on operation panel during the disinfection and rinsing.
(3) Operate the machine under dialysis mode to check no UF related error.
19-2
(1) Release two locks (front right and rear left sides) placed at casters.
(2) Move the machine under holding it upright.
(3) Move the machine by pushing rear side of it. It is recommended to push rear side by
one person and to support front side by other person to guide because forward view of
the former person may be blocked by the machine.
Moving
di ti
20-1
z Move the machine with care whether there is no obstacle on the way.
z To transport the machine by truck, hold the machine upright. DO NOT lay down the
machine.
CAUTION
z DO NOT hold plastic cover. Hold frame.
20-2
20-3
SPECIFICATIONS
21.1. Specifications for machine
21.1.1. Dimension and weight
Specifications Condition
Body dimension W: 450mm No
D: 600mm
H:1420mm (excluding IV pole)
H:1940mm (including IV pole)
Body mass 80kg (Dry mass) No
21-1
21-2
21-3
21.2.2. Deaeration
Specifications Condition
Deaeration Negative pressure deaeration system No
System
Gas dissolved in Max:130mmHg When PO2 is 200mmHg after
dialysate deaeration at a water temp.
of 37℃.
21-4
21-5
21-6
21-7
21-8
21-9
Capacity 1100mAh No
21-10
CAUTION
● Do not use disinfectant concentrate which is not suitable of using by heat. (For example,
acetic acid)
21-11
21-12
Arterial tube
MODEL№ A065(A067) TYPE (A)
22-1
Arterial tube
MODEL№ A064(A066) TYPE (A)
22-2
22-3
22-4
22-5
ACID
) A_concentrate or Acetate
2
T
U F
O
1 (T
1 U
T
U )
V O
3 O
4 3
N
I 1 1 F
(
T NV NV 2 5
N U
O
I I L V VLS
I S N D L
S B C
P 2 4
V V
R
MS
3 2 FF
V D
R T 3
B T
1 1 V
S D D P
A T C
B
M
1 5 7 O
P 2 VC
O
VO
C 9 C
N N N N V O C R
C a 12
b3 4
1 N
N E
P
HH
PP M M
O
HH
P PP C S
V
O
C C V P 2 Y
a b
S
L L
W C C 1 A
T V V R I
B D
M M
O
C
O
C 1 7
C F
O C C O D
2 6N
N 8N
N
P
1 T V V
V
R
1
H S
L
C
N PP
1
I
3 BB
V D V >
N L 2 A
B T
U
O V 2 P
R P <
2
2 C
1 T R P
T U N
I 2
O
W S P3
) S A SS
L
> 4 8 F
X V F
E (
H
<
N T
I U
O
FROM PATIENT
TO PATIENT
F 0 3
1 R
V
T
U
O 1
R
P
N
I
DRAIN
1 2 D
RO WATER Z Z E
B B R
Lamp
22-6
22-7
22-8