Commissioning and ServiceOnly trained personnel must service the Dialog+, i.e. repair, maintenance, software
!
Protective Conductor in TFT Housing
TSM Service Progr am
Prevent Chemical Burns and ScaldingDuring servicing on running machines: prevent chemical burns and scalding of the skin
Contaminated MachinesProtective gear should be worn in case of servicing of assumed contaminated
Disposal and Taking Back
System ConfigurationThe system configuration saved on a diskette must be downloaded to an other Dialog+
Service Manual1/2010
CopyrightThis document is the pr operty of B. Braun Avitu m AG with all rights reserved.
installation, firmware update, r etrofitting and commissioning of th e Dialog+.
Servicing must only be performed with proper tools, calibration equipment and be in
accordance with the most recent revision of this service manual/technical information,
which must be clearly and thoroughly understood.
Switch off the Dialog+ and disconnect unit from mains if you have to open the
machine for servicing. Do not touch any exposed wiring or conductive surfaces while
the Dialog+ is opened. The voltages present when electrical power is connected to the
Dialog+ can ca use serious injury or death.
ESD InformationPay attention to ESD information, because electronic components are sensitive to
electrostatic discharges.
High Voltage
in TFT Monitor
Software
Therapy Mode
Calibration
Tubing
Wiring
Cover in Rear DoorServicing of mechanical assembly groups (components in contact with fluid): the cover
O-RingsAlways check o-rings from disassembled groups/components and replace if necessary.
FiguresThe displayed figures can differ slightly from the machines on site, due to different
FusesIf fuses are replaced they must exactly match the type and rating specified by the
Spare PartsOnly use original spare parts manufactured and sold by B. Braun Avitum AG.
of Spare Parts
Function CheckCheck the respective function of the assembly group/component after servicing. A
If a battery option is present in the machine:
High voltage can be present at the backlight inverter board BIB in the TFT monitor,
even if the machine has been disconnected from mains. Pull out the battery
compartment in the base platform and switch off the battery voltage before opening
the machine.
If the TFT housing had to be opened during a service job, the tight seat of the
protective conductors in the TFT housing must be checked.
Only activate the TSM service program for service activities. It is prohibited to connect
a patient to the Dialog+ and to run a therapy if the TSM service program is activated
in the Dialog+. If the TSM service program is activated the complete alarm system is
disabled. The TSM service program is started in the service mode: digital board, service
switch S1, position 2.
The software is installed in the software mode: digital board, service switch S1,
position 3.
After completion of all procedures switch back to the therapy mode: digital board,
service switch S1, position 0.
Only perform a calibration after the Dialog+ has reached working temperature and the
machine was disinfected and decalcified. Save the calibration data (CFC) before you
exit the TSM service program:
Tubing must be replaced only by the same tubing type/length and identical installation
manner.
Make sure that the tubings in the machine are not kinked or twisted after servicing
(e.g. if sub-racks are pulled out and inserted again). The tubing must not touch
moving/rotating co mponents (e.g. motors of gear pumps).
Wiring must be replaced only by the same cable type/length and identical installation
manner. The cables must not touch moving/rotating components (e.g. motors of gear
pumps).
due to the penetration of disinfectant or hot liquid.
machines.
for the switch mode power supply microcontroller SMPS-MC in the rear door must be
assembled during servicing because it serves as a spray protection.
hardware statuses.
manufacturer in the spare parts list/technical information. Where applicable: fuses
must be approved by UL/CSA.
Dispose spare parts (e.g. boards or batteries) according to local disposal guidelines or
send back to B. Braun Avitum AG free of charge (see chapter 7).
machine only if:
•
the hardware matches and
•
the identical software version number is present.
complete function check must be performed after every service, according to the
operating manual.
TSM Main Menu, File Operations, Save Calibration Data
The edition of this service manual is for the maintenance and repair of the
Dialog+ machine with a software ≥ 9.01. The service manual is subject to
amendments.
A service training is essential to meet the B. Braun standard operating
procedures for qualified service and support.
The user of this documentation should only use this documentation in
combination with a participation in a B. Braun service training.
The user of this documentation should h ave the following qualifications and
prerequisites:
1. Mechanics, digital/analogue techniques, optoelectronics, measurement and
PC techniques.
2. Participation in a B. Braun service training to accomplish qualified
maintenance, repair and service support.
3. Availability of approved and calibrated test equipment and tools given in
this service manual.
Contact your local B. Braun representative or dealer for detailed inform ation
concerning training courses.
Perform regular technical safety inspections as described in chapter 5 of this
service manual to ensure the safety of the machine.
An instructions for use can be ordered at your local B. Braun representative or
dealer.
Please observe the ESD/EMC information (see appendix for additional
information):
• ESD: electrostatic discharge
• EMC: electromagnetic compatibility
Only original spare parts manufactured and sold by B. Braun are applicable.
Please provide part number and description respectively when ordering any
spare parts. Please order your spare parts at your local B. Braun representative
or dealer.
B. Braun Avitum AG
34209 Melsungen, Germa ny
Tel. No.:+49 5661 713662
E-Mail:heike.sinning@bbraun.com
dialysetechnik.melsungen@bbraun.com
The main assembly groups are defined according to the spare parts list. The
main assembly groups are especially:
• All pcb's (printed circuit boards)
• Pumps
• DF block
• Ultrafiltration
• Blood leak detector
• Safety air detector
• Heater
Tamper or repairs in these assembly groups are not permissible (due to
calibration, ESD, multi-layer pcb's and the application of SMT (SMT = surface
mounted technology).
All calibration devices must be approved and registered with an identification
number. The calibration equipment is subjec t to the B. Braun calibration service
and must be checked and recalibrated in regular intervals, to meet th e B. Braun
standard operating procedures SOPs. Only approved and registered calibration
equipment must be applied for servicing.
B. Braun Avitum AG
1. Commissioning 1/2010 1 - 1
Dialog
Copyright
Commissioning and Service
Prevent Electrical Shock Hazard
ESD Information
High Voltage
in TFT Monitor
Protective Conductor in TFT Housing
TSM Service Program
Software
Therapy Mode
Calibration
Prevent Chemical Burns and Scalding
Contaminated Machines
Cover in Rear Door
Tubing
Wiring
Fuses
Spare Parts
Instructions for Use
Check Machine
Commissioning
Electrical Installation
Mains Voltage Supply
Ambient Temperature
Water Installation
Water Quality
Central Hot Cleaning System
+
SW 9.xx
This document is the property of B. Braun Avitum AG with all rights reserved.
Only trained personnel must service the Dialog+, i.e. repair, maintenance, software installation, firmware
update, retrofitting and commissioning of the Dialog+.
Servicing must only be performed with proper tools, calibration equipment and be in accordance with the
most recent revision of this service manual/technical information, which must be clearly and thoroughly
understood.
Switch off the Dialog+ and disconnect unit from mains if you have to open the machine for servicing.
Do not touch any exposed wiring or conductive surfaces while the Dialog+ is opened. The voltages present
when electrical power is connected to the Dialog+ can cause serious injury or death.
Pay attention to ESD information, because electronic components are sensitive to electrostatic discharges.
If a battery option is present in the machine:
High voltage can be present at the backlight inverter board BIB in the TFT monitor, even if the machine has
!
been disconnected from mains. Pull out the battery compartment in the base platform and switch off the
battery voltage (remove fuse) before opening the machine.
If the TFT housing had to be opened during a service job, the tight seat of the protective conductors in the
TFT housing must be checked.
Only activate the TSM service program for service activities. It is prohibited to connect a patient to the
Dialog+ and to run a therapy if the TSM service program is activated in the Dialog+. If the TSM service
program is activated the complete alarm system is disabled. The TSM service program is started in the service
mode: digital board, service switch S1, position 2.
The software is installed in the software mode: digital board, service switch S1, position 3.
After completion of all procedures switch back to the therapy mode: digital board, service switch S1,
position 0.
Only perform a calibration after the Dialog+ has reached working temperature, and the machine was
disinfected and decalcified. You should save the calibration data to the hard disk drive before you exit the
TSM service program:
During servicing on running machines: prevent chemical burns and scalding of the skin due to the
penetration of disinfectant or hot liquid.
Protective gear should be worn in case of servicing of assumed contaminated machines.
Servicing of mechanical assembly groups (components in contact with fluid): the cover in the rear door must
be assembled during servicing because it serves as a spray protection for the SMPS-MC.
Tubing must be replaced only by the same tubing type/length and identical installation manner.
Make sure that the tubings in the machine are not kinked or twisted after servicing (e.g. if sub-racks are
pulled out and inserted again). The tubing must not touch moving/rotating components (e.g. motors of gear
pumps).
Wiring must be replaced only by the same cable type/length and identical installation manner. The cables
must not touch moving/rotating components (e.g. motors of gear pumps).
If fuses are replaced they must exactly match the type and rating specified by the manufacturer in the spare
parts list/technical information. Where applicable: fuses must be approved by UL/CSA.
Only use original spare parts manufactured and sold by B. Braun Avitum AG.
Please pay attention to the information in the instructions for use
Check completeness of machine and transport damages after unpacking.
Do not start machine if a safe operation is not guaranteed.
The electrical installation must correspond with national regulations for initial operation of the unit (e.g. IEC
publications). The machine must not be operated in hazardous locations or rooms. The potential equalisation
must be in accordance with national requirements (e.g. IEC publications)
The mains voltage supply must correspond with the mains voltage on the unit type plate!
Before the Dialog+ is switched on the machine must have room temperature (see instructions for use,
chapter 15).
The installation must be in accordance with national regulations e.g. DVGW work sheet W503 for
haemodialysis equipment and VDE 0753 (rules of application for haemodialysis equipment).
A pipe disconnector is not necessary if a water softener or water softener with built-in reverse osmosis
system is installed. A nonreturn valve and a bleed pipe are adequate. Please see DVGW work sheet W 503,
section 4.4 and VDE 0753 part 4 (Rules of application for haemodialysis equipment).
Only water of the highest quality should be applied. Please consider the following, especially for bicarbonate
dialysis:
• Inlet water shall be free of Mg
If the machine is connected to a central hot cleaning system a high temperature tubing must be used for the
water inlet.
TSM Main Menu, File Operations, Save Calibration Data
++
and Ca++.
.
BA-TE-DE08C M.KAY Dialog+ SW9xx_SM_Chapter 1-1_1-2010.doc/pdf <110301> yymmdd B. Braun Avitum AG
1. Commissioning 1/2010 1 - 2
1
Dialog
+
SW 9.xx
Legend
1. Type Plate
2. Canister Holder
3. Potential Equalisation Bolt
4. Main Cord
2
3
4
5
5. Central Concentrate Supply Option
6. Tubing Connection Water Inlet
•PVC tubing 10 x 3 mm (red)
(fasten with two single ear clamps 19.5)
•Tubing length: approx. 3 m
6.1 Tubing Connection Water Inlet for Osmosis Device
with Hot Disinfection of the Loop Line
•Silicone tubing 8 x 3.2 mm (high temperature tubing, red)
(fasten with two single ear clamps 19.5)
7. Tubing Connection Dialysate Outlet
•PVC tubing 10 x 3 mm (black)
(fasten with a single ear clamp 19.5 and a tubing clamp 1220 mm)
• Tubing length: approx. 3 m
• Drain height: max. 80 cm
8. Emergency Power Supply/Battery Option
6
7
8
Fig.: Dialog+ Rear View
BA-TE-DE08C M.KAY Dialog+ SW9xx_SM_Chapter 1-1_1-2010.doc/pdf <110301> yymmdd B. Braun Avitum AG
1. Commissioning 1/2010 1 - 3
Dialog
+
SW 9.xx
Table of Contents Page
1.1 Commissioning Check List
1.1.1 Measurement Circuits for the Measurement of the Electrical
Safety According to EN 62353/60601-1
1-4
1-6
BA-TE-DE08C M.KAY Dialog+ SW9xx_SM_Chapter 1-1_1-2010.doc/pdf <110301> yymmdd B. Braun Avitum AG
1. Commissioning 1/2010 1 - 4
Dialog
+
SW 9.xx
1.1 Commissioning Check List
For Dialog+ SW 9.xx
REF {Type/Typ}:................................................. SN {Serien-No./Nr.}: ................................................
Year of Purchase: ....................... Responsible Organisation (User): .....................................................
The commissioning (putting into service) shall be performed and documented before the machine
is handed over to the responsible organisation (user), according to the specified check list, with
reference to the service manual and instructions for use.
Manufacturer:
B. Braun Avitum AG
34209 Melsungen, Germany
Check List
Note: Text in { } brackets is information for the execution of the check list!
1. Visual Inspection
1.1 {Machine: clean/complete; no damages/moisture influences or loose assemblies; no moveable parts touching tubings or wires; casters are moveable;
type plate legible}
1.2 {Check tight seat and damages of mains supply (power supply cord, strain relief), potential equalisation cable, staff call/data lines (if present) and
connectors}
2. Protective Earth Resistance According to EN 62353
{(Machine in cl. power supply cord. Move the power supply cord during the check. Thus possible loose connections can be detected. Data lines and
potential equalisation cable must not be connected during the check of the of the protective earth resistance (see figure 1)}
{Measurement points:}
{Exterior: Potential equalisation bolt, rinsing bridge (dialyser inlet and outlet)}
{Interior: Heater body (top), rear door (top left corner), frame (rear), housing cover (top left), front door (top left)}
{Monitor: Monitor (one of the screws in the front panel/housing}
3. Install Machine
3.1 {Connect water inlet to the metal tubing connector and fasten with single ear clamp.
Connect dialysate outlet to plastic tubing connector and fasten with tubing clamp.}
3.2 {Connect central supply for concentrate (central supply option) and deaerate tubings}
3.3 {Assemble holder for disinfectant (if option present)}
2.22Switch Mode Power Supply Microcontroller SMPS-MC2-42
2.22.1Block Diagram SMPS-MC2-42
2.22.2System Integration SMPS-MC2-43
2.22.3Component Layout SMPS-MC2-44
2.22.4Wiring Diagram SMPS-MC with Battery Option2-45
2.22.5Description SMPS-MC2-46
2.22.6Fuses2-48
2.22.7Signals2-49
BA-TE-DE08C M.KAY
2.22.8Internal Signals2-49
Dialog+ SW 9xx_sm_C ha pter 2_1-2010.doc/pdf < 100329> yymmdd
B. Braun Avitum AG
+
Dialog
SW 9.xx
General Information
2. Technical System Description1/20102 - 4
Operation is accomplished via a touch screen (TFT monitor). Two
microprocessor systems c ontr o l a nd mo ni tor the machine.
The hardware concept consists of the following systems:
Top Level System
•
Low Level System
•
The top level system consists of the following components:
Top Level Syst em
Communication module
•
Top level controller TLC (motherboard)
•
Compact flash card CFC
•
Options
•
The communication between the user and the machine is performed via the
top level.
Example data excha nge to c o mmuni c ation module:
Entry via input mask of the touch screen or keyboard
•
Output via the output mask of the TF T mo ni tor
•
Example data exchange to low level:
Transmitting and receiving data from/to low level controller and supervisor
•
on the digital board DB (LLD)
Low Level Syst em
The low level system consists of the following components:
Digital board DB (LLD)
•
Analog board AB (LLA)
•
Power board motors PBM
•
Power board valves PBV
•
The low level controls and monitors all functions.
Data exchange to top level c o ntr ol l er ( mother b oard):
Transmitting and receiving data from/to low level supervisor
•
Transmitting and receiving data from/to low level controller
•
Data exchange between low level controller to supervisor:
Transmitting and receiving messages, data and commands
•
All sensor data are sent separately, v ia two serial bus systems, to the supervisor
and controller via the analog board to the digital board. The actuators, motors
and valves are driven via the power board valves PBV and power board motors
PBM.
BA-TE-DE08C M.KAY
Dialog+ SW 9xx_sm_C ha pter 2_1-2010.doc/pdf < 100329> yymmdd
B. Braun Avitum AG
Dialog
+
SW 9.xx
2. Technical System Description1/20102 - 3
For Software
For Software
For Software For Software
9.xx
9.xx
≥≥≥≥
9.xx 9.xx
BA-TE-DE08C M.KAY
Dialog+ SW 9xx_sm_C ha pter 2_1-2010.doc/pdf < 100329> yymmdd
B. Braun Avitum AG
Dialog
+
SW 9.xx
2. Technical System Description1/20102 - 5
2.1Overview Sub-Racks
4
11144
Fig. : Overview Sub-Racks Rear View Dialog+
2.1.1Legend Ov erv iew Sub-Racks
BA-TE-DE08C M.KAY
Top Level Sub-Rack
1
UF Sub-Rack
2
Dialog+ SW 9xx_sm_C ha pter 2_1-2010.doc/pdf < 100329> yymmdd
DF Sub-Rack
3
Water Sub-Rack
4
B. Braun Avitum AG
+
Dialog
2.2Top Level Sub-Rack
SW 9.xx
2. Technical System Description1/20102 - 6
1
USB:
Service
SW
Fig. : Top Level Sub-Rack
2
Motherboard
4
3
Basic Board
5
6
Power Board
Valves
Digital Board
USB:
Analog Board
7
SW
89
JP2
S1
JP1
Power Board Motors
HDF BoardOnline
2.2.1Legend To p Level Sub-Rack
1111USB Port:
Service (FSU)/Software Installation TLC
2222 LX800 Motherboard
3333 Temperature Switch TS (closes at 50 ± 3
4444 Basis Board BB
5555 Power Board Valves PBV
6666 Digital Board DB (LLD):
USB Port: Software Installation LLC/LLS; Service-Switch S1; Jumper JP1/JP2
7777 HDF Online Board HOB
8888 Power Board Motor PBM
9999 Analog Board AB (LLA)
o
C, opens at 35 ± 6 oC)
BA-TE-DE08C M.KAY
Dialog+ SW 9xx_sm_C ha pter 2_1-2010.doc/pdf < 100329> yymmdd
Controller LEDs D13 – D20:Controller LEDs D13 – D20:
Status 0 – 7 for installation of LLC software
FPGA LEDs V7 – V9
FPGA LEDs V7 – V9: always ON
FPGA LEDs V7 – V9FPGA LEDs V7 – V9
Voltages for FPGA (U30) and periphery
(FPGA: Field Programmable Gate Array – configurable logical circuit)
LED V10
LED V10: flashes permanently
LED V10LED V10
Cycle time, system is running
Supervisor LEDs V11 – V18
Supervisor LEDs V11 – V18:
Supervisor LEDs V11 – V18Supervisor LEDs V11 – V18
Status 0 – 7 for installation of LLS software
LED V5
LED V5: always ON after loading
LED V5LED V5
The content of the memory (U45) is loaded to FPGA (U30) during
switch-on. The therapy program and the service program is stored
in the RAM (U45).
Fig. : Water Sub-RackFig. : Water Block with Valves for BIC Option
2.12.1Legend Wat er Sub -Ra c k
Water Block WAB
VB
VB and Heat Exchanger WT
VBVB
Pressure Reducer DMV
Degassing Pressure Sensor PE
Degassing Chamber EK
Degassing Pump EP
Heater HHHH
Degassing Temperature S e nso r TSE
Heater Temperature Sensor TSH
Heater Inlet Temperature Sensor TSHE
BA-TE-DE08C M.KAY
WAB (with integrated Degassing Chamber EK
WABWAB
WT)
WTWT
DMV
DMVDMV
PE
PEPE
EK
EKEK
EP (Motor Cover AAAA)
EPEP
TSE
TSETSE
TSH
TSHTSH
TSHE
TSHETSHE
Dialog+ SW 9xx_sm_C ha pter 2_1-2010.doc/pdf < 100329> yymmdd
EK, Upline Tank
EKEK
Upline Tank Inlet Valve VVBE
Upline Tank VB
Additional Components for Option BIC Cartridge:
Additional Components for Option BIC Cartridge:
Additional Components for Option BIC Cartridge:Additional Components for Option BIC Cartridge:
Throttle BIC Cartridge Holder DBK
BIC Concentrate Suction Rod Valve VBKS
Top BIC Cartridge Valve VBKS
BIC Pump Valve VBICP
Upline Tank Valve VVB