Professional Documents
Culture Documents
AquaBplus
Disinfection with
Puristeril 340 / Puristeril plus
Service Manual
Edition: 1/08.12
Part no.: 636 551 1
Table of contents
1 Index
2 Important information
2.1 How to use the Service Manual................................................................................................ 2-1
2.2 Significance of warnings .......................................................................................................... 2-1
2.3 Significance of notes ................................................................................................................ 2-2
2.4 Significance of tips.................................................................................................................... 2-2
2.5 Technician's qualification......................................................................................................... 2-2
2.6 Considerations for working on the device.............................................................................. 2-2
2.7 Technical documentation ......................................................................................................... 2-3
2.8 Warnings .................................................................................................................................... 2-3
2.8.1 Electrical warnings....................................................................................................................... 2-3
2.9 Addresses .................................................................................................................................. 2-4
3 Material
3.1 Material required........................................................................................................................ 3-1
3.2 Approved disinfectants............................................................................................................. 3-1
3.3 Concentration for use ............................................................................................................... 3-1
3.4 Test for absence of disinfectant .............................................................................................. 3-1
4 System configuration
4.1 Intended use .............................................................................................................................. 4-1
4.1.1 Interface disinfection process flowchart................................................................................. 4-1
4.2 Requirements............................................................................................................................. 4-2
4.3 Configuration ............................................................................................................................. 4-4
4.3.1 4008 hemodialysis system .......................................................................................................... 4-4
4.3.2 5008 / 5008S therapy system...................................................................................................... 4-5
6 Appendix
6.1 Protocol ...................................................................................................................................... 6-2
1 Index
A T
Addresses 2-4 Technical documentation 2-3
Appendix 6-1 Technician's qualification 2-2
Approved disinfectants 3-1 Test for absence of disinfectant
3-1
C Tip, significance 2-2
D
Description of the procedure 5-1
Disinfection 5-2
H
How to use the Service Manual 2-1
I
Important information 2-1
Intended use 4-1
M
Material 3-1
Material required 3-1
N
Note, significance 2-2
P
Precautions 5-1
R
Report 6-2
Requirements 4-2
S
System configuration 4-1
2 Important information
Purpose This document is intended for service technicians and is to be used for
first studies (to acquire a basic knowledge) and for reference purposes
(for TSC, maintenance and repair). The document does not replace the
training courses offered by the manufacturer.
Identification The document can be identified by the following information on the title
page and on the labels, if any:
– Document edition
– Document part number
Organization of the To facilitate the use of documents from Fresenius Medical Care, the
chapters organization of the chapters has been standardized in all manuals.
There may therefore be chapters within this document without any
content. Chapters without content are identified.
Illustrations The illustrations used in the documents may differ from the original if
this does not have any influence on the function.
Warning
Advises the operator that failure to observe this information can result
in personal injury.
Note
Advises the operator that failure to observe this information can:
– cause damage to the equipment
– result in a specific function not being executed at all or not being
executed correctly
Tip
Information providing useful tips for easy handling.
Requirements The technician must be familiar with the contents of the latest Operating
Instructions of the respective device.
The technician must be proficient in mechanics and electrical and
medical technology.
Test equipment and The activities described in this document require the availability of the
accessories necessary technical test equipment and accessories.
ESD precautions When repairing the device and when replacing spare parts, observe the
applicable ESD precautions.
2.8 Warnings
Warning
Risk of injury caused by electrical voltage.
Touching live parts will cause an electric shock.
– Disconnect the power plug before opening the device. Operating the
On/Off switch stops operation of the device, but does not disconnect
the device from the supply voltage!
2.9 Addresses
Local service
3 Material
Note
Only approved disinfectants may be used.
4 System configuration
↓
Turning on all dialysis systems integrated
in the process
↓
Interruption of the permeate flow to the
dialysis systems by opening the shunt
interlock
↓
Starting the Int. disinfection program on
the AquaBplus
Drawing in the standard disinfection
volume.
↓
Drawing the disinfectant into the dialysis
devicesby groups (for one minute)
↓
Continuing disinfection of the system and
of the ring main
↓
Rinsing the RO
↓
Rinsing the dialysis devices
↓
Standard disinfection of the dialysis
devices
4.2 Requirements
Warning
All equipment or consumers not integrated in the disinfection process
must be disconnected prior to the disinfection.
A permeate tank, which might be present, must be disconnected from
the ring main and must be disinfected separately.
A concentrate mixing system, which may be present, must be
disconnected from the ring main.
A Granumix Plus must be in Standby mode or must be set to RO
disinfection via the control input. At the end of the rinse procedure, it
must be cleaned as specified in the chapter "Disinfection of the
permeate ring main" in the Service Manual of the Granumix Plus by a
technician who has attended a Granumix Plus training course.
If external water inlet filters are installed on the integrated hemodialysis
devices, these must be removed before performing the interface
disinfection.
Do not integrate any devices of other manufacturers into the disinfection
process!
Note
The disinfection should be performed by two persons, one of whom
must be a trained and authorized technician.
Performance of the interface chemical disinfection is the responsibility
of the responsible organization. Requirements are the knowledge of the
topography of the ring main, the proper function of all affected
components and compliance of the installation with the specifications
defined by Fresenius Medical Care.
Only devices of the 5008 / 5008S therapy system and of the 4008
hemodialysis system may be integrated in the disinfection process!
If the Flush path is integrated in the hemodialysis device, it must be
activated in the Setup menu (5008 only). On 5008 / 5008S therapy
systems the endless rinse program can only be started with the
ServiceCard. In 4008 devices, the program is part of the rinse programs
and can be started from there.
Mixing of disinfectants must be prevented:
Ensure that there is no disinfectant already present in the hemodialysis
devices, e.g., premature termination of a standard disinfection program
of the dialysis device.
Do not integrate any devices of other manufacturers into the disinfection
process!
The following principle must always be observed when performing a
chemical disinfection:
Rinsing of disinfectant from the overall system or absence of
disinfectant in the system always has priority over the efficacy of the
disinfection performed.
Note
The interface disinfection must be performed on a scheduled basis and
sufficient time must be reserved for this procedure.
Performance of the disinfection must be recorded!
4.3 Configuration
Warning
After an endless rinse program the system must be free from
disinfectant. Following this, a standard disinfection program must be
performed on the hemodialysis devices.
Start the Endless rinse program and interrupt the program by opening
the shunt interlock.
– Lift the shunt interlock flap.
– The dialysate couplings must remain in the shunt interlock.
The end of the initial test phase (after approx. 5 min) is indicated by the
fact that no additional program name is displayed below the name of the
program.
Do not terminate the program as otherwise the initial test phase will
have to be repeated.
5.1 Precautions
Warning
When handling disinfectants, care must be taken not to spill any
disinfectant concentrate. To prevent acid burns, these fluids must
always be handled with care.
Observe the specifications on the safety data sheet and use the
personal protective equipment.
This includes particularly
– Acid-resistant protective clothing
– Protective gloves
– Tight-closing goggles
General safety precautions:
– Avoid any contact with eyes and skin.
– Do not breathe gases/vapors/aerosols.
5.2 Disinfection
The disinfectant volume depends on the system type and on the total
length of the permeate ring main. The following table lists the required
disinfectant volumes, necessary to obtain approx. 4 % concentration in
the permeate, rounded up to container figures.
Note
For disinfection purposes, disconnect the tank control plug for tank
operation and deactivate the tank control in the Settings menu.
0–50 1 1 1 1 1 1
50–100 1 1 2 2 2 2
100–150 1 1 2 2 2 2
150–200 2 2 2 2 2 2
200–250 2 2 2 2 2 2
250–300 2 2 2 2 2 2
300–350 2 2 2 2 2 2
350–400 2 2 2 2 2 2
400–450 2 3 3 3 3 3
450–500 3 2 3 3 3 3
0-50 2 2 2 3 3
50-100 2 2 2 3 3
100-150 2 2 3 3 3
150-200 2 3 3 3 3
200-250 3 3 3 3 3
250-300 3 3 3 3 3
300-350 3 3 3 3 3
350–400 3 3 3 3 3
400-450 3 3 3 3 3
450–500 3 3 4 4 4
The volume determined on the basis of the table is the volume required
for the disinfection of the reverse osmosis system. 1 (for up to 40
devices) to 2 additional containers (for up to 70 devices) with
disinfectant are required for the disinfection of the dialysis devices.
For the disinfection, the dialysis devices must be divided into groups.
8 liters of disinfectant are available for each group. This corresponds to
8 dialysis devices. Before the start of the disinfection, the dialysis
devices must therefore be divided into groups of 8 devices each. This
must be documented in the report in Chapter 6.1, step B.
STANDBY
DISINFECTION
DISINFECTION
Terminate disinf.
Confirm
Note
Before confirming the selected menu option Confirm with the Enter
key, the disinfection connector must be disconnected from the system
and must be connected to the disinfectant container.
DISINFECTION
DISINFECTION
Phase 2/7 Distribution When the disinfection connector is connected to its original port,
phase 2/7 Distribution will start.
DISINFECTION
During this phase, the disinfectant is distributed in the system and the
ring main. During the first 12 seconds of the distribution phase, water
inlet valve V10 is opened to prevent possible loss of water by
compression of air in the system.
DISINFECTION
Puristeril 340
Permeate conductivity + 300µS/cm
Puristeril plus
Permeate conductivity + 800µS/cm
If these values are not achieved, more disinfectant must be added. If
the target values have been achieved, phase 3/7 can be started with the
menu option Start consumption.
Phase 3/7 Consumption While consumption is in progress, the following screen will be
displayed:
DISINFECTION
DISINFECTION
During the dwell phase, the disinfectant is circulated in the system and
in the ring main(s) just like during the distribution phase.
DISINFECTION
DISINFECTION
When the programmed volume has been reached, the system will
automatically start the idle time. This idle phase lasts 5 minutes.
Phase 7/7 Rinse phase 2 On completion of the idle time, the system will automatically start rinse
phase 2.
While rinsing of the reverse osmosis system is in progress, rinsing on
the dialysis device is started. Restart the endless rinse on the devices
(on 5008 devices with the ServiceCard).
DISINFECTION
During the rinse phase, the programmed rinse volume is being rinsed
from the system and the ring main just as during the first rinse phase.
This rinse phase can be repeated as often as required.
DISINFECTION
When 66% of the programmed rinse volume has been reached, the
operator is prompted to test for residual disinfectant.
If there is still disinfectant in the system or the ring main, the rinse
procedure must be repeated.
DISINFECTION
When the rinse volume has been reached and there is no operator
input, the AquaBplus will perform a rinse at regular intervals. The
interval will be taken from the "Automatic rinse - Rinse - Interval"
setting. If Automatic rinse has been deactivated, this interval will be
4 hours. A timer with the respective interval will be started and the
remaining time until the next rinse will be displayed next to the
parameter Repeat Rinse.
The test for residual disinfectant with the peracetic acid test strip must
be performed at the last user point in the permeate ring main or ring
mains, at all unused permeate couplings, on the drain and the overflow
of the reverse osmosis system.
Warning
The reverse osmosis system and the ring main must be checked for the
absence of residual disinfectant with peracetic acid test strips. Observe
the instructions for use of the test strips used.
If the test shows a residual concentration of peracetic acid, the rinse
program must be repeated until all residual disinfectant has been
completely removed.
4008 series:
If absence of disinfectant has been ensured on the drain of the 4008,
the Endless rinse program can be terminated.
To check the Flush for absence of disinfectant, turn the dialysis device
off and on again. After turning power On, the device will perform the
Flush cycles and the test for absence of disinfectant can be carried out.
As long as residual disinfectant is still present, start further Flush cycles
by turning the device off/on.
5008 / 5008S:
In 5008 / 5008S devices the Flush is rinsed during the entire Endless
rinse program. The Endless rinse program must therefore be performed
until absence of disinfectant has been ensured both on the drain and on
the Flush.
Note
Continue the Endless rinse of all integrated hemodialysis devices until
absence of disinfectant has been ensured on the drain and Flush (if
present) of all devices.
Warning
After an endless rinse program the system must be free from
disinfectant. Following this, a standard disinfection program must be
performed on the integrated hemodialysis devices as specified in the
respective Operating Instructions.
Use the form provided (see Chapter 6.1 on page 6-2) to document the
disinfection process!
Warning
At the end of the free rinse procedure, the Granumix Plus (if present)
must be rinsed and checked for residual disinfectant by a trained
technician as specified in the chapter "Disinfection of the permeate ring
main" in the Granumix Plus Service Manual.
6 Appendix
6.1 Protocol
Customer: Date:
City: Technician 1:
Phone: Technician 2:
All systems have been disinfected according to instruction procedure and have been checked for absence of disinfectant.
Signature technician 1: Signature technician 2:
Signature / date, customer:
Customer: Date:
City: Technician 1:
Phone: Technician 2:
Absence of disinfectant
Absence of disinfectant
Attention 8 devices per
Not integrated
Disconnected
disinfection
performed
Integrated
Standard
group
.
The complete system has been disinfected according to instruction procedure and has been checked for absence of
disinfectant.