CH01EN General Desciptions
CH01EN General Desciptions
CH01EN General Desciptions
Contents
The microbiological quality of the dialysis fluid is The conductivity of the water, i.e. its ability to
a function of a number of factors. Neglecting conduct a current, is a measure of the amount of
only one of these could result in a poor quality. dissolved salts in water. It is therefore a good
These factors are: indicator of the quality of the water as well as
the performance of different water treatment
• Acceptable quality of the inlet water to the processes, such as reverse osmosis.
water treatment system, i.e. in accordance
with standards for drinking water. Conductivity in water is normally expressed in
microsiemens per cm (µS/cm).
• High capacity of reduction of microorganisms
and endotoxin in the water treatment The amount of dissolved salts in the source
system. This requires both the necessary water varies significantly from place to place and
purification steps (e.g. RO) as well as hygienic may also change over time due to seasonal
design and correct maintenance including variations. As reverse osmosis removes a
regular cleaning and disinfection. percentage of the salts (approximately 95%), the
pure water conductivity will also vary depending
• Hygienic design of the distribution system of on the quality of the inlet water.
treated water to the dialysis clinic with
smooth surfaces and with a minimum of The conductivity of the water, however, is not
joints and stagnant zones. always a good indicator of the suitability of the
water for dialysis. Aluminium, for example, may
• Frequent disinfection of the distribution be present in concentrations well exceeding
system. recommended standards without affecting the
conductivity.
• Hygienic design and regular cleaning and
disinfection of the dialysis machines. The quality of dialysis water should therefore
always be verified by regular water analyses.
• High quality and proper handling of
bicarbonate concentrates. The conductivity should mainly be used as an
indicator of the performance of the reverse
• Correct arrangement of the drain connections osmosis system.
from the dialysis machines, i.e., an air gap to
avoid microbial contamination from the
drainage system.
Note: The regulations and guidelines on the quality requirements for dialysis water varies in
different countries around the world. In US, the AAMI (Association for the Advancement of
Medical Instrumentation) has issued standards for water for dialysis which have been used for
more than 15 years as a guideline for water for dialysis. In Europe The EUROPEAN
PHARMACOPOEIA has issued guidelines (1992) that regulates the microbiological as well as the
chemical requirements for water for dialysis in Europe, as well as analysis methods to be used both
for the microbiological and chemical testing of water.
semipermeable
membrane
pure water
(permeate)
water inlet
pump
reject recirculation
reject to
drain
Circulation of hot water in the distribution The heating of the water in the tank to 90°C
system should be performed on a regular basis, should be set to start two hours before the
preferably every day, to minimize bacterial dialysis session normally ends. By doing this, the
growth in the distribution system. tank temperature will be 90°C at the time that
Hot water circulation is initiated by the operator the operator starts the hot water circulation and
at the end of the dialysis session. A special code the necessary time to reach the acceptance
is also required to avoid inadvertant start of the temperature (see below) will be the shortest
process. possible.
Hot water will then be circulated in the loop
until it is interrupted, either manually by the Note: The temperature of the water in the tank
operator, or automatically at a preset time. will drop momentarily when the hot water
circulation is initiated. This is because of the
HW - unit cold water from the loop returning to the tank.
The temperature will then gradually increase.
The heating unit consists of a tank made of
stainless steel and an electrical heater . The Acceptance temperature
tank is filled up with pure water from the RO-
unit. The effective volume of the tank is 270 The periods for heating to 90°C should be long
liters or 340 liters, depending of size of the CWP. enough to allow the return water from the clinic,
The heating unit also contains level swiches (93, at least once every circulation period, to reach
94) and temperature sensors (56, 92) to monitor the preset acceptance temperature. This is
and control the operation of the unit. normally is set at 85°C. Other settings may,
The tank temperature in the tank is displayed however, be required, depending on the length of
continuously on the operator´s panel during the loop, insulation properties et.c.
periods when hot water is circulated. An alarm will notify the operator if the
acceptance temperature for some reason has not
Heating periods been reached.
The temperature of the water in the tank is Caution: Disinfection of the water distribution
always maintained at minimum 63°C (Low on loop cannot be assured unless 85 °C is circulated
the display). It is periodically increased to 90°C in the distribution loop for at least 10 minutes.
(High on the display). These heating periods to
90°C must be adapted to the operation schedule
for the specific clinic and are set by technical
personnel during installation and start up. Refer
to the Installation section.
101 93
92 T 90
94
HEAT
91
54
P retreated 95 143 96
wate r in let 56
32 106
1 T
3 µS 5 52 P3 51
133 From c li ni c
4
6 125
64
35
48 103 105 104
33 P1 µS 9
P2
RO
71 T o c li ni c
36 102
34
122
41
di si nfe ction ope rati on
62 61
Fig. 4.
45
6
5
44
4
111
53
110
42
138
34
134
92
94 33
41
62
96 95 91 47 32 71 51 3 1
64 P2
9
36 35
48
122
103
102
105
104
125
Circulation pump for hot water (96) Note: The part of the product water that is not
used in the clinic will also be recirculated to the
This pump circulates hot water from the tank to
inlet tank. The quality of the product water will
the distribution system during heat disinfection
remain unchanged, regardless of the degree of
periods.
recirculation of reject.
A B E F I J A B
M N Q R U V ` ´
HW HW ALARM
STATUS
STOP START 4 5 6 ACK
O P S T W X : ,
Y Z C1 C2 C5 C6
ALARM MAIN 1 2 3
LIST MENU ° % C3 C4 C7 C8
+ = ( ) ! ?
- 0 Enter
Fig. 6. Operator´s panel
/ < > #
*
The operator´s panel on the front of the RO-unit is used for the operation of the system 1). It is also
used for alarm information and when setting certain parameters. The display normally shows a
limited amount of information about the operational status of the system. More detailed information
can also be selected (refer to Service and maintenance).
1)
If the system is in remote control mode, start and stop of operation and heat disinfection can only be
done from the remote control unit (not from the operator´s panel). Refer to Remote control.
2)
The system also has an autostart function at a preset time, refer to Service and maintenance.
3)
If a restart is done within 10 minutes after a stop, the system will delete the five minutes flush.
The cursor in the upper left corner of the display is used when
searching for information.
STAND BY
Arrow Buttons
The arrow buttons are used to move the cursor to desired position on the display.
1 2 9 Numbered Buttons
The numbered buttons are used to enter the operator´s (see below) or technician’s code when
required. They are also used for setting of technical parameters, together with the - button. Refer to
Service and maintenance for more information.
ENTER
The ENTER - button is used to confirm entered information and to perform commands.
Operator´s code
To avoid an inadvertent start of the heat or chemical disinfection modes, a special operator’s code +
ENTER is required before the start of any of these modes is possible.
Note: The cursor must be in the top left corner when the code is entered.
DISINF
These buttons are used to start and stop the circulation of hot water in the distribution system.
STATUS
When this button is pressed the screen displays status information. If the detailed (versus standard)
display has been selected, the indication will return to normal reading by keeping STATUS
depressed for 5 seconds, independent of previous display.
ALARM ALARM
LIST ACK
These buttons are used for handling of alarms in alarm situations. Refer to Alarm information on
page 1:14
Clear
The Clear - button is used during programming to delete unwanted digits or signs.
The information button is used to bring up the time display on the alarm list (refer to page 1:14)
and to get information about setting ranges during setting of technical parameters.
3. Selecting Test operation will start the system and let it run for 20 minutes with all product
water being diverted to drain. This mode is useful in service situations.
To initiate test operation: Enter the operator´s code and press ENTER.
AUT - Normal position. The water saving control system follows what is set in the technical level,
Refer to Service and maintenance for more information.
MAN - The water saving control system is disenganged and the CWP is operated with the motor
valve 138 fully open to drain.
2 Vacant - - -
3.Drain valve error the motor valve is in wrong position 115, 116 A
12.V-test ph1 bef. flow error (F5) in phase 1 of valve test 1 (before disinf) 3, 42 A
13.V-test ph1 aft. flow error (F5) in phase 1 of valve test 2 (after disinf) 3, 42 A
18.Vacant - -
19.HW loop leakage low return flow during hot water circulation 51 A
20.V-test ph2 bef. flow error (F5) in phase 2 of valve test 1 (before disinf) 3, 42 A
21.V-test ph3 bef. flow error (F5) in phase 3 of valve test 1 (before disinf) 3, 42 A
22.V-test ph4 bef. flow error (F5) in phase 4 of valve test 1 (before disinf) 3, 42 A
23.V-test ph2 aft. flow error (F5) in phase 2 of valve test 2 (after disinf) 3, 42 A
24.V-test ph3 aft. flow error (F5) in phase 3 of valve test 2 (after disinf) 3, 42 A
25.V-test ph4 aft. flow error (F5) in phase 4 of valve test 2 (after disinf) 3, 42 A
27.Battery low PLC the PLC battery voltage is < 3.0V (internal)
Phase Minutes Each phase takes 1.5 min., i. e. total duration for
each cycle is 6 minutes. Refer to Service and
Valve test 1 6 maintenance for more information.
Proportioning of disinfectant 15
1)
Circulation of disinfectant 20 Loop test
Rinse 90
Valve test 2 6 If an alarm occurs in valve test 2 (after
Total 137 disinfection), an extra test of the water in the
distribution system is required before the system
Table 2. Disinfection programme can be put into normal operation again. To
1)
If formaldehyde is used for disinfection, the program
indicate this, “loop test required” will appear
should be manually interrupted after the cicrulation
phase for minimum 2 hours to obtain sufficient
on the display during stand by and the flush-to-
contact time. drain period at start up. When the flush is ready
and the water is diverted to the loop, the display
Refer to Operating Instructions for starting will still read START UP but the text “test the
cleaning/disinfection. loop” will appear. To avoid inadvertent use of
Refer to Service and maintenance for more the water before the test has been performed,
information. the system will operate intermittently until the
test has been confirmed by dialling in the
Safety during disinfection operator´s code + ENTER.
A loop test will also be mandatory after a total
stop and when the fast stepping function has
A solenoid valve arrangement on the pure water
been used. Refer to Service and maintenance
outlet line creates an air gap (open to
and Trouble shooting guide for more
atmosphere) between the RO-unit and the
information.
distribution system during disinfection periods,
The water treatment system is thereby isolated
Note: Confirmation of the loop test has to be
from the loop during these periods (fig. 7).
done while the system is in operation and the
display is in normal (not detailed) mode. Refer to
Valve test Service and maintenance p.4:2 for more info.
The function of the valves included in the air gap
arrangement is checked in a four-phase
sequence before as well as after the
disinfection cycle. The HW circulation pump
stops (if in operation) and the main pump is in Air gap
operation during the test. If any of the flow
demands is not fulfilled an alarm will be issued
Open
press press
Phase
START for 5 DISINF
seconds
Valve test 1 (before System goes into test after Valve test restarts. The
disinfection) disinfection. disinfection procedure then
continues.
Valve test 2 (after In case of low level inlet Valve test 2 restarts.
disinfection) or flow alarm: System goes
into test after disinfection.
Note: Loop test will be
required, refer to page 1:17
Other alarms or manual
stop: Valve test 2 restarts
lamp
indication
unit
buzzer
key
selector
box
Fig. 10. CWP 100 with external indication and
remote control