B.Braun Dialog+ Service manual 1

Download

Dialo

SW 9.xx

Service Manual

English

Edition 1 -2010

M.KAY Dialog+ SW9xx SM EN 1-2010

Dialog

SW 9.xx

Service Manual 1/2010

Contact your Local

B. Braun Representative

for Service Support

B. Braun Avitum AG

BA-TE-DE08C M.KAY -

34209 Melsungen Germany

Tel. No.: +49 5661 713500 (Günter Ni ssen) E-Mail: guenter.nissen@bbra un.com

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B. Braun Avitum AG

Dialog

SW 9.xx

Service Manual 1/2010

Valid for the following machine type:

For Software ≥ 9.xx Dialog+: from serial no. 100000 Dialog+ HDF-Online: from serial no. 150000

BA-TE-DE08C M.KAY -

Registration Number:

Service Manuals with a registr ation nu mber a re inclu ded in the upda te serv ice!

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B. Braun Avitum AG

Dialog

Prevent Electrical Shock H azard

SW 9.xx

Commissioning and Service Only trained personnel must service the Dialog+, i.e. repair, maintenance, software

Protective Conductor in TFT Housing

TSM Service Progr am

Prevent Chemical Burns and Scalding During servicing on running machines: prevent chemical burns and scalding of the skin

Contaminated Machines Protective gear should be worn in case of servicing of assumed contaminated

Disposal and Taking Back

System Configuration The system configuration saved on a diskette must be downloaded to an other Dialog+

Service Manual 1/2010

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 Information Pay 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 Door Servicing of mechanical assembly groups (components in contact with fluid): the cover

O-Rings Always check o-rings from disassembled groups/components and replace if necessary.

Figures The displayed figures can differ slightly from the machines on site, due to different

Fuses If fuses are replaced they must exactly match the type and rating specified by the

Spare Parts Only use original spare parts manufactured and sold by B. Braun Avitum AG.

of Spare Parts

Function Check Check 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

III

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B. Braun Avitum AG

Dialog

SW 9.xx

Service Manual 1/2010

Table of C ont e nt s Pa ge

1. Installation and Commissioning

2. Technical System Description

3. Repair Instructions

4. TSM Service Program

5. Technical Safety Inspection with Preventive Maintenance

6. Flow, Wiring and Tubing Diagrams

7. Spare Parts List

8. Appendix

8.1 ESD/EMC Information

8.1.1 Electrostatic Discharge ESD

8.1.2 Electromagnetic Compatibility EMC

1-1 2-1 3-1 4-1 5-1 6-1 7-1 8-1 8-2 8-2 8-4

8.2 Technical Information

8.3 Assembly Instructions

8.4 Field Service Information

8.5 Instruction Leaflets

9. Edition/Updates Service Manual

9-1

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B. Braun Avitum AG

Dialog

Conventions

SW 9.xx

Service Manual 1/2010

Symbol Description

Attention

The symbol gives information, which are safety relevant for the Dialog+ and must be observed.

Information

The symbol gives additional information, which should be observed.

Tips

The symbol gives additional hints, which can be helpful.

Handling

The symbol gives information for a handling at or in the machine, i.e. during a calibration, disassembly or assembly.

Calibration

The symbol appears for necessary calibration measures.

Calibration Equip m ent / Tools

The symbol gives remarks for necessary calibration equipment/tools, i.e. during a calibration, disassembly or assembly.

BA-TE-DE08C M.KAY -

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B. Braun Avitum AG

Dialog

SW 9.xx

Service Manual 1/2010

Service Manual

Service Training

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.

B. Braun Avitum AG

34209 Melsungen, Germa ny Tel.: +49 5661 712718 Fax.: +49 5661 752718 E-Mail: marina.ritz-nickel@bbraun.com

Technical Safety Inspection

Instructions for Use

ESD/EMC Information

Spare Parts

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).

Calibration Serv ice

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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

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

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.

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++.

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1. Commissioning 1/2010 1 - 2

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

Fig.: Dialog+ Rear View

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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

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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): .....................................................

.........................................................................................................................................................................

Operating Hours: .................................... h Inventory No.: ..................................................................

SW Version: ...........................................

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

2.1 Protective Earth Resistance:

< 0.3 [Ω] {note highest value}: ................................................ [Ω]

{(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)}

3.4 {Assemble dialyser holder}

3.5 {Assemble filter holder. Insert DF filter (option)}

3.6 {Assemble DF filter/HDF filter (if option present)}



4. Function Inspection

{Pay attention to the filling procedure of the machine to prevent dry run of the heater!}

4.1 Switch on machine, fill and rinse: - {Switch machine in Test 1.10 Degassing and Heating menu and fill with water until

water flows out of the dialysate outlet. Then rinse in disinfection (approx. 5 minutes).}

4.2 Automatic Blood Pressure Measurement ABPM

4.2.1 ABPM Option: - Measurement on a test person is plausible

4.3 Customer Specific System Setting: - {Switch machine in TSM Service Program: Execute Treatment Support (calibrate PE offset for

altitudes > 1000 m}

Option present no  yes 

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

1. Commissioning 1/2010 1 - 5

Dialog

Check List

SW 9.xx

Note: Text in { } brackets is information for the execution of the check list! SN {Serien-No./Nr.}............................................

5. Setting into Service According to Instructions for Use with Electrical Safety Check According to

EN 62353/EN 60601-1

5.1 Applied Accessories/Disposables:

- Applied line system:

Name: ......................................................................................................................................................................................

5.2 Switch on machine: - Self-test passed {and 15 minutes therapy with UF safety check}

- Ultrafiltration comparison measurement 15 minutes with UF rate 500 ml/h: ......................... [ml]

(125 ml UF volume ±15 ml)

5.3 Temperature: - Comparison measurement {at dialyser coupling}, at 37 oC (-1.5; +0.5): ......................... [oC]

5.4 Conductivity: - Comparison measurement {at dialyser coupling}, e.g. 14.3 mS/cm (±0.2): ................. [mS/cm]

5.5 Equipment Leakage Current:

{All water connections and data lines must be connected during the check of the equipment leakage current (see figure 2)}

≤ 0.5 [mA] - During heat-up phase {change mains polarity and note highest value}: ....................... [mA]

5.6 Patient Leakage Current:

{All water connections and data lines must be connected during the check of the patient leakage current (see figure 3)}

< 10 [µA] AC - Under normal conditions {at dialyser coupling}, conductivity at 13 – 15 mS/cm: ........................ [µA]

5.7 Safety Air Detector (SAD): - Test alarm function (visual/audible) passed

5.8 Disinfection: - Start

Applied Measurement Equipment:

Electrical Safety: ........................................................................................ * ID/Serial No.: .................................

Conductivity: ............................................................................................... * ID/Serial No.: .................................

Temperature: ............................................................................................... * ID/Serial No.: .................................



Pressure: ....................................................................................................... * ID/Serial No.: .................................

Balance: ........................................................................................................ * ID/Serial No.: .................................

Pressure Manometer: ............................................................................... * ID/Serial No.: .................................

Other Measurement Device: ................................................................... * ID/Serial No.: .................................

......................................................................................................................... * ID/Serial No.: .................................

* If applicable, please enter the type and identification number of the equipment used.

Comments:

..........................................................................................................................................................................................................................................................

Next Inspection Date:

The commissioning was performed and the machine was hand over to the responsible

organisation (user).

............................................................................................................................................................

Name Service Technician: Name of Company:

...................................................................................

................................................................................... .................................................................

Date/Signature

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1. Commissioning 1/2010 1 - 6

Dialog

1.1.1 Measurement Circuits for Measurement of Electrical Safety

SW 9.xx

According to IEC 62353/60601-1

Protective earth (ground)

L, N

Supply mains terminals

Mains part

Measuring device

Resistance measurement equipment

Part of enclosure not protectively earthed

Table 1: Legend of Abbreviations and Symbols

Protective earth terminal

Applied part

Residual current meter with frequency response as MD

Connection to accessible conductive parts

Protective Earth Resistance

Test current: ≥ 200 mA The test current must be measured in both

directions.

Fig. 1: Protective Earth Resistance

L(N)

N(L)

Fig. 2: Equipment Leakage Current

Equipment Leakage Current:

• Differential Measurement

Patient Leakage Current

Fig. 3: Patient Leakage Current

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Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 1

Table of Content s Page

General Information 2-4

2.1 Overview Sub-Racks 2-5

2.1.1 Legend Overview Sub-Racks 2-5

2.2 Top Level Sub-Rack 2-6

2.2.1 Legend Top Level Sub-Rack 2-6

2.3 Basic Board BB 2-7

2.3.1 Legend Basic Board 2-7

2.4 Power Board Valves PBV 2-8

2.4.1 Legend Power Board Valves 2-8

2.5 Power Board Motors PBM 2-9

2.5.1 Legend Power Board Motors 2-9

2.6 Digital Board DB 2-10

2.6.1 Legend Digital Board 2-10

2.7 Analog Board AB 2-11

2.7.1 Legend Analog Board 2-11

2.8 HDF Online Board HOB 2-12

2.8.1 Legend HDF Online Board 2-12

2.9 UF Sub-Rack 2-13

2.9.1 Legend UF Sub-Rack 2-13

2.10 UF Sub-Rack HDF Online 2-14

2.10.1 Legend UF Sub-Rack HDF Online 2-14

2.11 DF Sub-Rack 2-15

2.11.1 Legend DF Sub-Rack 2-15

2.12 Water Sub-Rack 2-16

2.12.1 Legend Water Sub-Rack 2-16

2.13 Rinsing Bridge 2-17

BA-TE-DE08C M.KAY

2.13.1 Legend Rinsing Bridge 2-17

2.14 Rear Door 2-18

2.14.1 Legend Rear Door 2-18

2.15 Switch Mode Power Supply Microcontroller SMPS-MC 2-19

2.15.1 Legend Switch Mode Power Supply Microcontroller 2-19

2.16 TFT Monitor 2-20

2.16.1 Legend TFT Monitor 2-20

2.17 Front Door 2-21

2.17.1 Legend Front Door 2-21

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Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 2

2.18 Level Regulation Module 2-22

2.18.1 Legend Level Regulation Module 2-22

2.18.2 Flow Diagram Level Regulation Module 2-23

2.19 Flow Diagrams 2-24

2.19.1 Dialog+ 2-24

2.19.2 Dialog+ with BIC Option and DF Filter Option 2-25

2.19.3 Dialog+ HDF Online 2-26

2.19.4 Legend Flow Diagram 2-27

2.20 Description Flow Diagram 2-29

2.20.1 Water Inlet Section with Water Block 2-29

2.20.2 Degassing Circuit with Temperature System 2-30

2.20.3 Dialysate Processing 2-31

2.20.4 Central Bicarbonate and Concentrate Supply (Option) 2-32

2.20.5 BIC Cartridge Holder (Option) 2-32

2.20.6 Balance Chamber System 2-33

2.20.7 Working Principle Balance Chamber System 2-33

2.20.8 Ultrafiltration and Rinsing Bridge 2-35

2.20.9 Chemical Thermal Disinfection Program 2-36

2.21 Block Diagram 2-38

2.21.1 Legend Block Diagram 2-39

2.22 Switch Mode Power Supply Microcontroller SMPS-MC 2-42

2.22.1 Block Diagram SMPS-MC 2-42

2.22.2 System Integration SMPS-MC 2-43

2.22.3 Component Layout SMPS-MC 2-44

2.22.4 Wiring Diagram SMPS-MC with Battery Option 2-45

2.22.5 Description SMPS-MC 2-46

2.22.6 Fuses 2-48

2.22.7 Signals 2-49

BA-TE-DE08C M.KAY

2.22.8 Internal Signals 2-49

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Dialog

SW 9.xx

General Information

2. Technical System Description 1/2010 2 - 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.

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Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 3

For Software

For Software For Software

9.xx

≥≥≥≥

9.xx 9.xx

BA-TE-DE08C M.KAY

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SW 9.xx

2. Technical System Description 1/2010 2 - 5

2.1 Overview Sub-Racks

11144

Fig. : Overview Sub-Racks Rear View Dialog+

2.1.1 Legend Ov erv iew Sub-Racks

BA-TE-DE08C M.KAY

Top Level Sub-Rack

UF Sub-Rack

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DF Sub-Rack

Water Sub-Rack

B. Braun Avitum AG

Dialog

2.2 Top Level Sub-Rack

SW 9.xx

2. Technical System Description 1/2010 2 - 6

USB:

Service

Fig. : Top Level Sub-Rack

Motherboard

Basic Board

Power Board

Valves

Digital Board

USB:

Analog Board

JP2

JP1

Power Board Motors

HDF BoardOnline

2.2.1 Legend To p Level Sub-Rack

1111 USB 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)

C, opens at 35 ± 6 oC)

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2.3 Basic Board BB

2. Technical System Description 1/2010 2 - 7

P48

P26

P17

P54

P58

P31

P10

P49

P51

P32

P24

P50

Fig. : Basic Board

2.3.1 Legend Basic Board

P1 Degassing Pump EP

P1P1 P2

P2 Venous Blood Pump BPV

P2P2 P3

P3 Arterial Blood Pump BPA

P3P3 P4

P4 Outlet Flow Pump FPA

P4P4 P5

P5 Safety Air Detector SAD

P5P5 P6

P6 Heparin Pump HP (HEP)

P6P6 P7

P7 Air Separator Level Sensor LAFS

P7P7 P8

P8 BIC Pump BICP

P8P8 P9

P9 Concentrate Pump KP

P9P9 P10

P10 All Valves (+ Option BIC) VALVES

P10P10 P11

P11 Level Regulation LR

P11P11 P12

P12 DIABUS

P12P12 P13

P13 HDF Online Board HOB

P13P13 P14

P14 Front Panel Board FPB

P14P14 P15

P15 Valves Balance Chamber VCH

P15P15 P16

P16 UF Pump UFP

P16P16 P17

P17 Power Supply 1 PS1

P17P17 P18

P18 Not Applicable

P18P18 P19

P19 Not Applicable

P19P19 P20

P20 Inlet Flow Pump FPE

P20P20 P21/P22

P21/P22 Power Board Valves PBV

P21/P22P21/P22 P23

P23 Staff Call PERS-R

P23P23 P24

P24 Control SMPS-MS (NT)

P24P24 P25

P25 Power Board Motors PBM

P25P25 P26

P26 Disinfection Valve VD

P26P26

DIABUS

DIABUSDIABUS

SMPS-MS (NT)

SMPS-MS (NT)SMPS-MS (NT)

P59

BICP

BICPBICP

UFP

UFPUFP

PERS-R

PERS-RPERS-R

P23

EPEP

BPV

BPVBPV

BPA

BPABPA

FPA

FPAFPA

SAD

SADSAD

HP (HEP)

HP (HEP)HP (HEP)

KPKP

LRLR

HOB

HOBHOB FPB

FPBFPB

PS1

PS1PS1

FPE

FPEFPE

PBV

PBVPBV

VDVD

PBM

PBMPBM

P11

P21

P18

P33

LAFS

LAFSLAFS

VALVES

VALVESVALVES

VCH

VCHVCH

P47

P38P45P39 P30

P13

P25

P7 P44

P27

P27 Membrane Position Sensors Balance Chamber MSBK

P27P27 P28

P28 Temperature Sensor Dialysate TSD

P28P28 P29

P29 Temperature Sensor Heater Inlet TSHE

P29P29 P30

P30 Degassing Temperature Sensor TSE

P30P30 P31

P31 Level Sensor Upline Tank NSVB

P31P31 P32

P32 Blood Leak Detector BL

P32P32 P33/P34

P33/P34 Digital Board DB

P33/P34P33/P34 P35

P35 Temperature Sensor BIC TSBIC

P35P35 P36

P36 Temperature Sensor Dialyser Inlet TSDE

P36P36 P37

P37 Temperature Sensor Dialysate Supervisor TSD-S

P37P37 P38

P38 Pressure Sensor Dialysate Outlet PDA

P38P38 P39

P39 Blood Side Pressure Sensor PBLOOD

P39P39 P40/P41

P40/P41 Analog Board AB (LLA)

P40/P41P40/P41 P42

P42 END Conductivity Sensor (Controller/Supervisor) ENDLF+S

P42P42 P44

P44 B IC Conductivity S ensor BICLF

P44P44 P45

P45 Pressure Sensor Degassing PE

P45P45 P47

P47 Speed/Rotation Direction Venous Blood Pump DZ/DR BPV

P47P47 P48

P48 Speed/Rotation Direction Arterial Blood Pump DZ/DR BPA

P48P48 P49

P49 BIC and Concentrate Sensors for Suction Rods BIC-K

P49P49 P50

P50 Rinsing Bridge Sensors SBS

P50P50 P51

P51 BIC Cartridge Holder Sensor BKUS

P51P51 P54

P54 Power Supply 2 PS2

P54P54 P57

P57 Power Supply Bedside Link BSL-PWR

P57P57 P58/P60

P58/P60 Power Supply Hall Sensors

P58/P60P58/P60

P29

DBDB

AB (LLA)

AB (LLA)AB (LLA)

PS2

PS2PS2

P22

P19

P34

P41P40

BLBL

P15

SBS

SBSSBS

NSVB

NSVBNSVB

TSBIC

TSBICTSBIC

PBLOOD

PBLOODPBLOOD

BICLF

BICLFBICLF

PEPE

BKUS

BKUSBKUS

BSL-PWR

BSL-PWRBSL-PWR

P16

TSD

TSDTSD

TSE

TSETSE

TSHE

TSHETSHE

TSDE

TSDETSDE

PDA

PDAPDA

P20

P57

P60

P14

P12

P27

P42

P37P35P28

TSD-S

TSD-STSD-S

P36

MSBK

MSBKMSBK

ENDLF+S

ENDLF+SENDLF+S

DZ/DR BPV

DZ/DR BPVDZ/DR BPV

DZ/DR BPA

DZ/DR BPADZ/DR BPA BIC-K

BIC-KBIC-K

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 8

2.4 Power Board Valves PBV

Fig. : Power Board Valves

U13

U18

U23

2.4.1 Legend Power Boa rd Valves

P1 Valves:

Inlet Upline Tank Valve Degassing Inlet Valve Air Separator Valve Luftabscheide r Dialyser Inlet Valve Dialyser Outlet Valve Bypass Valve Option BIC Cartridge Valves Disinfection Valve Circulation Valve Venous Tubing Clamp Arterial Tubing Clamp

VBP

VVBE

VEB

VDE

VDA

VBICP, VBKS, VBKO, VVB

SAKV

SAKA

VLA

P2 Valves:

Valve Balance Chamber Valves Level Module

VBT, VPV, VPE, VPU, VPD, VPA

VDEBK1/2, VDABK1/2, VEBK1/2, VABK1/2

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B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 9

2.5 Power Board Motors PBM

Fig. : Power Board Motors

2.5.1 Legend Power Board M otors

P1 BIC Piston Pump BICP

P1P1

Concentrate Piston Pump KP UF Piston Pump UFP Level Regulation Pump (Diaphragm Pump) LRP (PPR)

BICP

BICPBICP

UFP

UFPUFP

KPKP

U10

C19

U13

C26

U19

LRP (PPR)

LRP (PPR)LRP (PPR)

U2 U4 U6

U12

C38

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2.6 Digital Board DB

2. Technical System Description 1/2010 2 - 10

U39

U28

P11

U35

U55

U36

U56

U33

U43

P13

Controller

JP1

Supervisor

L33

U30

FPGA

U27

U46

U53

D16

D17

D18

D19

D20

D21

D22

D23

D24

D25

D26

D27

U45

D28

D29

D34

D30

D35

D31

D32

D33

D13

JP2

P14

D16

D17

D18

D19

D20

D21

JP1

0123456

CWP

Fig. : Digital Board DB (LLD) with Controller and Supervisor

2.6.1 Legend Digital Board

Calibration Data

All calibration data are stored on the digital board. The calibration data must be stored additionally on the compact flash card CFC.

12 Bit AD Converter

Both supervisor and controller have a 12 bit AD converter with a range of 0 to 4095.

P4/P5/P6/P7/P13/P14

USB Type A for SW installation with USB stick

P11 Supervisor Sensors:

BICPOS, KPPOS, UFPOS

Controller/Supervisor Sensors:

BKUS, SBS1, SBS2, BPS_IMP, BPA_DIR, BPV_IMP, BPV_DIR

Pumps:

BPA, BPV, EP, FPA, FPE

Controller Sensors:

NSVB, BICSS, KSS, MSBK1/2, RDV, SAD, BPADS, BPVDS, BL (Controller/Supervisor Sensor Analog Board)

Controller

: not applicable

D28

D29

D30

D31

D32

D24

D25

D26

D22

D23

D27

01234567

D33

D34

Supervisor

Jumper JP1:

Jumper JP1:Jumper JP1: Default: Controller Write Protect CWP (for controller firmware)

Controller LEDs D13 – D20:

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).

Jumper JP2:

Jumper JP2:Jumper JP2: Default: Supervisor Write Protect SWP (for supervisor firmware)

S1 Service Switch:

Position 0: Position 2: Position 3:

Therapy Mode TSM Service Program Mode Software Installation/Update Mode

D13

D35

JP2

SWP

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2.7 Analog Board AB

2. Technical System Description 1/2010 2 - 11

U35

Fig. : Analog Board AB (LLA)

U36 U37

U32

U40

U41

U42

U46

U39

U43

U47

U21

U33

U38

U29

U44

U48

U50

U28

U45

U49

2.7.1 Legend Analog Board

P1/P2 Controller Sensors:

PBS, TSHE, TSE, TSB IC, TSD, TSDE, BICLF, ENDLF, PE, LAFS

Supervisor Sensors:

TSD-S, ENDLF-S

Controller/Supervisor Sensors:

BL, PBE, PA, PV, PDA

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 12

2.8 HDF Online Board HOB

Fig. : HDF Online Board

2.8.1 Legend HDF Online Board

Sensors:

P1:

PSABFS, PSAUS, PSPOSS, FEHDFS, FEDFFS P4

: Valves

VBE, VDFF, VSAA, VSAE, VSB

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2.9 UF Sub-Rack

MSBKB1/2

2. Technical System Description 1/2010 2 - 13

VDEBK1

VDA

VLA

VEBK1

VABK2

MSBK2

VDEBK2

DDE

RVFPA

VLA

VBP

VEBK2

VABK1

VDABK2

VABK1

VBP

DDE

RVFPA

VDEBK2

MSBKB1/2

VABK2

VDEBK1

Fig. : UF Sub-Rack

2.9.1 Legend UF Sub-Rack

Balance Chamber BK1/2 Bypass Valve VBP Throttle Dialyser Inlet DDE Air Separator LA Membrane Position Sensor Balance Chamber Board MSBKB1/2 Membrane Position Sensor Balance Chamber MSBK1/2 Non-Return Valve Outlet Flow Pump RVFPA Outlet Balance Chamber Valve VABK1

VBP

VBPVBP

LALA

BK1/2

BK1/2BK1/2

DDE

DDEDDE

VABK1

VABK1VABK1

RVFPA

RVFPARVFPA

VDA

MSBKB1/2

MSBKB1/2MSBKB1/2

MSBK1/2

MSBK1/2MSBK1/2

VEBK1

Outlet Balance Chamber Valve VABK2 Outlet Dialyser Balance Chamber Valve VDABK1 Outlet Dialyser Balance Chamber Valve VDABK2 Inlet Dialyser Balance Chamber Valve VDEBK1 Inlet Dialyser Balance Chamber Valve VDEBK2 Inlet Balance Chamber Valve VEBK1 Inlet Balance Chamber Valve VEBK2 Air Separator Valve VLA

VDABK1

VEBK1

VEBK1VEBK1 VEBK2

VEBK2VEBK2

VLA

VLAVLA

VABK2

VABK2VABK2

VDABK1

VDABK1VDABK1 VDABK2

VDABK2VDABK2

VDEBK1

VDEBK1VDEBK1 VDEBK2

VDEBK2VDEBK2

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 14

2.10 UF Sub-Rack HDF Online VBE

MSBKB1/2

VABK2

MSBK2

VDEBK2

DDE

VDEBK1

VDABK2

VDA

HFB

VSB

VEBK1

VSAE

VSAA

VSAE

VEBK2

VBP

VABK1

VSAA

VABK1

VLA

DDE

RVFPA

VDEBK2

RVFPA

Fig. : UF Sub-Rack HDF Online

2.10.1 Legend U F Sub-Rack HDF Online

Balance Chamber BK1/2 Bypass Valve VBP Throttle Dialyser Inlet DDE Hydrophobic Vent Filter HFB Air Separator LA Membrane Position Sensor Balance Chamber Board MSBKB1/2 Membrane Position Sensor Balance Chamber MSBK1/2 Non-Return Valve Outlet Flow Pump RVFPA Outlet Balance Chamber Valve VABK1/2

VBP

VBPVBP

LALA

BK1/2

BK1/2BK1/2

DDE

DDEDDE

HFB

HFBHFB

VLA

VABK1/2

VABK1/2VABK1/2

VBP

RVFPA

RVFPARVFPA

VDA

MSBKB1/2

MSBKB1/2MSBKB1/2

MSBK1/2

MSBK1/2MSBK1/2

HFB

VEBK1

MSBKB1/2

VABK2

VDEBK1

VBE

VDABK1

VSB

Outlet Dialyser Balance Chamber Valve VDABK1/2 Inlet Dialyser Balance Chamber Valve VDEBK1/2 Inlet Balance Chamber Valve VEBK1/2 Air Separator Valve VLA

Additional Co

Substitute Bypass Valve VSB Substitute Connection Outlet Valve VSAA Substitute Connection Inlet Valve VSAE Filter Vent Valve VBE

VLA

VLAVLA

mponents

mponents mponents

VBE

VBEVBE

VEBK1/2

VEBK1/2VEBK1/2

for HDF Online:

VSB

VSBVSB

VDABK1/2

VDABK1/2VDABK1/2

VDEBK1/2

VDEBK1/2VDEBK1/2

VSAA

VSAAVSAA

VSAE

VSAEVSAE

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2.11 DF Sub-Rack

2. Technical System Description 1/2010 2 - 15

FPA

FPE

ENDLF

BICLF

RVK

TSDS

RVFPE

RVB

BICP

UFP

RFUFP

BICP

RVB

Fig. : DF Sub-Rack

2.11.1 Legend DF Sub-Rack

RVK

UFP

BICLF

TSBIC

ENDLF

TSD

FPE

FPA

BIC Pump BICP Degassing Pressure Sensor PE END Conductivity/Supervisor ENDLF/ENDLF-S Outlet Flow Pump FPA Inlet Flow Pump FPE Concentrate Pump KP Bicarbonate Conductivity Sensor BICLF Bicarbonate Non-Return Valve RVB

BA-TE-DE08C M.KAY

BICP

BICPBICP

PEPE

ENDLF/ENDLF-S

ENDLF/ENDLF-SENDLF/ENDLF-S

FPA (Motor Cover AAAA)

FPAFPA

FPE (Motor Cover AAAA)

FPEFPE

KPKP

BICLF

BICLFBICLF

RVB

RVBRVB

Dialog+ SW 9xx_sm_C ha pter 2_1-2010.doc/pdf < 100329> yymmdd

Non-Return Valve Flow Pump Inlet RVFPE Non-Return Valve Concentrate RVK Non-Return Valve UF Pump RFUFP Bicarbonate Temperature Sensor TSBIC Dialysate Temperature Sensor TSD Dialysate Supervisor Temperature Sensor TSD-S UF Pump UFP

UFP

UFPUFP

RVK

RVKRVK

RFUFP

RFUFPRFUFP

TSD

TSDTSD

RVFPE

RVFPERVFPE

TSBIC

TSBICTSBIC

TSD-S

TSD-STSD-S

B. Braun Avitum AG

Dialog

SW 9.xx

2.12 Water Sub-Rack

2. Technical System Description 1/2010 2 - 16

NSVB

WAB

VEB

NSVB

VVBE

WA-Block

VEB

RVDA

VBKS

VBICP

DBK

VBKO

VVB

VEB

DMV

Fig. : Water Sub-Rack Fig. : Water Block with Valves for BIC Option

2.12.1 Legend 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

PEPE

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: Throttle BIC Cartridge Holder DBK BIC Concentrate Suction Rod Valve VBKS Top BIC Cartridge Valve VBKS BIC Pump Valve VBICP Upline Tank Valve VVB

VBVB

VBICP

VBICPVBICP

VVB

VVBVVB

VVBE

VVBEVVBE

VBKS

VBKSVBKS

DBK

DBKDBK

VBKS

VBKSVBKS

B. Braun Avitum AG

Dialog

2.13 Rinsing Bridge

SW 9.xx

2. Technical System Description 1/2010 2 - 17

Fig. : Rinsing Bridge

2.13.1 Legend Rinsing Bridge

PDA

TSDE

VDE

1111 Disinfection Valve VD 2222 Pressure Sensor Dialysate Outlet PDA 3333 Dialyser Inlet Valve VDE

VDVD

VDE

VDEVDE

PDA

PDAPDA

4444 Temperature Sensor Dialyser Inlet TSDE 5555 Blood Leak Detector BL

BLBL

TSDE

TSDETSDE

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2.14 Rear Door

2. Technical System Description 1/2010 2 - 18

Fig. : Rear Door

2.14.1 Legend Rear Doo r

Switch Mode Power Supply Microcontroller SMPS-MC

Fan

SMPS-MC

SMPS-MCSMPS-MC

Mains Switch

Mains Cord

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 19

2.15 Switch Mode Power Supply

Microcontroller SMPS-MC

P12

P10

H401

H303

H301

H302

H304

H601

H602

H402

H403

F401

F303

F301

F302

F304

F601

F602

F402

F403

H104

H300

F600

+24VGB / T3.15A TR5

+24 VGD / T3.15A TR5

H600

X104

H900

C115

C114

+12VAN / T1.25A TR5 +24VL / M10.00A TR5

X100

XP3.2 XP3.1

X103

P14

X903

GNDAKKU +24VAKKU

P11

X101

+12VD / T3.15A TR5

+5VD / T3.15A TR5

+5VD / T5.00A TR5

+5VD / T3.15A TR5

+12VD / T5.00A TR5

BENNING XXXXX XXXXXX XXXXXX

Netzgerät/Power Supply NT-Dialog-MC XXXXXXXX

SN/SNo: XXXXXXX Bj/Year: XX/XX

TN /Item-No:XXXX XX.5 Ver/SW: Rev 1.15

Opt.: Art/mode: XX/xx Eingang/Input Ausgang/Output

Art/Kind AC DC Hz 50-60 V 110/12 0/230/240 A 5/2,3

H401

H303

H301

H302

H304

H601

H602

H402

H403

F401

F303

F301

F302

F304

F601

F602

F402

F403

H300

F600

F1 T6.25A 6.3x32 (X1.1: L) F2 T6.25A 6.3x32 (X1.1: L) F5A 110/120V: F12A 6.3x32 (X1.6: HZG1-L) 230V: T6.25A 6.3x32 (X1.6: HZG1-L ) F5B 110/120V: F12A 6.3x32 (X1.7: HZG2-L) 230V: T6.25A 6.3x32 (X1.7: HZG2-L ) F6 110/120V: F20A 6.3x32 (X1 . 5: HZG-N) 230V: F12A 6.3x32 (X1.5: HZG-N) F301 T3.15A TR5 (+5VD1) F302 T5.0A TR5 (+5VD2) F303 T3.15A TR5 (+5VD3) F304 T3.15A TR5 (+5VD4) F401 T3.15A TR5 (+12VD1) F402 T5.00A TR5 (+12VD2) F403 T1.25A TR5 (+12VA) F600 M10.00A 6.3x32 (+24VL) F601 T3.15A TR5 (+24VGB) F602 T3.15A TR5 (+24VGD)

H600

F5A

F5B

X1.6

LH1 LH2

F2 F1

X1.3

X1.5

X1.4

PE1

X1.1

X1.2

LNPE

X1.8

X1.7

Fig. : Switch Mode Power Supply Microcontroller SMPS-MC

2.15.1 Legend Switch Mode Power Supply

Microcontroller

X1.1

X1.1 Mains Input L

X1.1X1.1 X1.2

X1.2 Mains Input N

X1.2X1.2 X1.3

X1.3 Mains Input PE

X1.3X1.3 X1.4

X1.4 Heater PE1

X1.4X1.4 X1.5

X1.5 Heater N

X1.5X1.5 X1.6

X1.6 Heater LH1

X1.6X1.6 X1.7

X1.7 Heater LH2

X1.7X1.7 X1.8

X1.8 PE

X1.8X1.8 P2

P2 Power Supply Control from Low Level Digital Board/Basic Board

P2P2 XP3

XP3 Battery Connection (Screw Terminal)

XP3XP3 P4

P4 24 V Voltages

P4P4 F1/F2

F1/F2 6.25 AT (6.3x32), Mains Input

F1/F2F1/F2 F5A/F5B

F5A/F5B 12 AF (6.3x32), Heater 1800 W (110/ 120 V )

F5A/F5BF5A/F5B

6.25 AT (6.3x32), Heater 1800 W (230/ 240 V )

F6 20 AF (6.3x32), Heater 1800 W (110/120 V)

F6F6

12 AF (6.3x32), Heater 1800 W (230/ 240 V )

F301

F301 3.15 AT (TR5), +5 VD

F301F301 F302

F302 5.00 AT (TR5), +5 VD

F302F302

Type Plate SMPS-MC

TN/Item-No (Version Numb er SM P S-M C) :

TN/Item-No (Version Numb er SM P S-M C) : e.g. XXXXXX.5 Ver/SW (SW Version):

TN/Item-No (Version Numb er SM P S-M C) :TN/Item-No (Version Numb er SM P S-M C) :

P5 12 V Voltages

P5P5 P7

P7 ABPM Option

P7P7 P8

P8 DSI Option

P8P8 P9

P9 Fan, Mains Switch

P9P9 P10

P10 Motherboard, Front Panel Board

P10P10 P12

P12 Options

P12P12 P13

P13 -

P13P13 P14

P14 EXT EIN

P14P14 P101

P101 Service Watchdog

P101P101 X100

X100 Fan

X100X100

F303/F304

F303/F304 3.15 AT (TR5), +5 VD

F303/F304F303/F304 F401

F401 3.15 AT (TR5), +12 VD

F401F401 F402

F402 5.00 AT (TR5), +12 VD

F402F402 F403

F403 1.25 AT (TR5), +12 VAN

F403F403 F600

F600 10 AM (6.3x32), +24 VL

F600F600 F601/F602

F601/F602 3.15 AT (TR5), +24 VGB

F601/F602F601/F602

Ver/SW (SW Version): e.g. Rev. 1.15

Ver/SW (SW Version):Ver/SW (SW Version):

BA-TE-DE08C M.KAY

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2.16 TFT Monitor

2. Technical System Description 1/2010 2 - 20

Fig. : TFT Monitor

2.16.1 Legend TF T M onitor

Backlight Inverter Board Front Panel Board

BA-TE-DE08C M.KAY

TFT Monitor

FPB

TFT

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BIB

Optical Status Display Board Touch Controller Board Touch Screen

TCB

OSDB

B. Braun Avitum AG

Dialog

SW 9.xx

2.17 Front Door

2. Technical System Description 1/2010 2 - 21

PV PA PBS/SN PBE

PBA PBV

SAD

SAKV-SG

SAKA

SAD

PV PA

PBA PBV

SAKASAKV-SG

2222

Fig. : Front Door with Double Pump Fig. : Front Door for HDF Online

1111

PBS/SN

PBE

2222

LRM

SAD

SAKV-SG

PBE

LRP

PBS/SN

PBV

1111

LRP

PBE

PBV

22222

Fig. : Front Door (Inside) with Double Pump Fig. : Front Door (Inside) for HDF Online

PBS/SN

PBA

SAKA

PBA

SAKA

LRM

SAD

SAKV-SG

2.17.1 Legend Front Door

Cover for Suction Rods 2222 Arterial Blood Pump BPA Venous Blood Pump BPV Pressure Sensor PBE Pressure Sensor PBS/SN

PBE

PBEPBE PBS/SN

PBS/SNPBS/SN Arterial Pressure Sensor PA Venous Pressure Sensor PV

BA-TE-DE08C M.KAY

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BPA

BPABPA

BPV

BPVBPV

PAPA

PVPV

Heparin Pump Compact HP Arterial Tubing Clamp SAKA Venous Tubing Clamp Current Closed SAKV-SG Safety Air Detector SAD

HPHP

SAKA

SAKASAKA

SAKV-SG

SAKV-SGSAKV-SG

SAD/Venous Red Detector RDV

SADSAD Substitution Port 1111 Connection for concentrat e S uct i o n R o d s 2222

B. Braun Avitum AG

RDV

RDVRDV

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 22

2.18 Level Regulation Module

HFE

PBS

PBE

LRP

HFS

HFP

HFV

HFA

PA PV PBS PBE

HFV

Fig. : Level Regulation Module and Level Regulation Pump

2.18.1 Legend Level Regula t ion Module

There are two level regulation modules with different assemblies, i.e. for machines with a sin gle blood pump and with a double blood pump.

Inlet Pressure Sensor Valve VPE Down Pressure Sensor Valve VPD Up Pressure Sensor Valve VPU Blood Control Pressure Sensor Valve VPS Venous Pressure Sensor Valv e VPV Arterial Pressure Sensor Valve VPA Blood Side Test Pressure Sensor Valve VBT

PV PBE

VPE

VPEVPE

VPD

VPDVPD

VPU

VPUVPU

VPV

VPVVPV

VPA

VPAVPA

LRP

VPS (Double Pump)

VPSVPS

VBT

VBTVBT

HFS

OUT

HFE

PBS

OUT

Arterial Hydrophobic Filter HFA Venous Hydrophobic Filter HFV Blood Control Pressure Hydrophobic Filter HFS (Double Pump) Inlet Hydrophobic Filter HFE Pump Hydrophobic Filter (Ceramic Filter) HFP

HFE

HFEHFE

HFA

HFAHFA

HFV

HFVHFV

HFS

HFSHFS

HFP

HFPHFP

BA-TE-DE08C M.KAY

Level Regulation Pump LRP

LRP

LRPLRP

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Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 23

2.18.2 Flow Diagram Level

Regulation

Module

Front Door

Outside

Inside

HFA

HFV

HFE

HFS

VBT

PBE

PBS

VPA

VPV

VPE

Level Module

VPD

VPU

HFP

LRP

OUT

PA Chamber PV Chamber

Fig. : Flow Diagram Level Regulation Module

PBE Chamber

3/2 Way Solenoid Valve

There are two level regulation modules with different assemblies, i.e. for machines with a single blood pump and with a double blood pump. The level regulation module and the level regulation pump inside of the rear door. The level regulation module and functions;

Setting of the level in all blood side chambers (3/2 way solenoid valves

•

VPV, VPE, VPU, VPD

Monitoring of the blood side pressures (pressure sensors PA, PV,

•

)

PBS

Test of the blood side pressure sensors in preparation (3/2 way solenoid

•

valve

VBT

)

and diaphrag m pump

LRP

are assembled on the

LRP

have the following

LRP

)

PBE

VPA

and

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B. Braun Avitum AG

Dialog

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2.19 Flow Diagrams

2.19.1 Dialog+

2. Technical System Description 1/2010 2 - 24

Z.D.

PEV*

Dialyser

V.D.

FVD

SB1

SB2

Rinsing Bridge

UF Sub-Rac k

DF Sub-Rack

PDA BL

VBP

VLA

LAFS

FBK2

VDABK2

VABK1

DDE VDETSDE

BK1

Balance Chamber

VDEBK1

RVFPE

FPE

TSD-S

ENDLF-S

ENDLFBICLFTSBIC

T T

TSD

VABK2

VDABK1

MSBK1

VEBK1

FBK1

RVK

VEBK2

VDEBK2

SBS1

Air

VDA

FPA

BK2

MSBK2

RVDA

SBS2

LVD

RVFPA

UFP

RVUFP

Supply

KVABV A

Central Concentrate

FKFB

KSS

SKKSSKBS

BIC

Supply

Central Bicarbonate

(Unit Rear)

Disinfectant

Acid Concentrate

BIC Concentrate

KSB KSK

Disinfectant

Blood Venous

Housing

Dialysate Outlet

Water Inlet

BA-TE-DE08C M.KAY

RVB

BICP

TSE

WAB

H NSVB

Water Sub-Rack

VB WT

DMV

VVBE

TSH

TSHE

FEP

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Air

Dialysate Flow 2

Dialysate

Blood Arterial

VEB

Bicarbonate

Water

Concentrate

Dialysate Flow 1

B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 25

2.19.2 Dialog+ with BIC Option and DF Filter Option

Z.D.

PEV*

Dialyser

V.D.

FVD

SB1

SB2

SBS1

Air

VDA

FPA

BK2

RVDA

VLA

VABK2

VDEBK2

PDA BL

LAFS

FBK2

VDABK2

MSBK2

VEBK2

RVFPE

TSDE

DF Filter *

DDE

VDE

VBP

VABK1

VDABK1

BK1

Balance Chamber

TSD-S

MSBK1

VEBK1

VDEBK1

FBK1

FPE

ENDLF-S

Rinsing Bridge

Rear DoorWater Sub-Rack

SBS2

LVD

RVFPA

UFP

RVUFP

Supply

KVA

Central Conc en tr a te

FKFB

KSS

SKKSSKBS

(Unit Rear)

Disinfectant

Acid Concentrate

ENDLFBICLFTSBIC

WAB

VB WT EK

RVK

RVB

Kt/V-UV*

BICP

VBICP*

VBKO*

TSH

TSHE

FEP

TSD

DF Sub-Rack UF Sub-Rack

DBK*

Dialysate Outlet

Water Inlet

DMV

VVBE

TSE H NSVB

BIC

VBKS

BVA

FBIC

RVBO*

VVB*

VEB

BIC Co n centr ate

Supply

Central Bi car b ona t e

KSB KSK

Disinfectant

Blood Venous

SPA

BKUS

Dialysate Flow 2

RVBU

Water

Housing

Options

Air

Dialysate

Bicarbonate

Blood Arter ial

Concentrate

Dialysate Flow 1

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 26

2.19.3 Dialog+ HDF Online

PSAUS

VSAEVSB

Front Door

PSABF

VSAA

FSU

Z.D.

PEV*

Dialyser

V.D.

FVD

SB1

SB2

HFB

PDA

VDE

Rinsing Bridge

VBP

TSDE

VBE

HDF Filter

DF Filter

Rear Door

UF Sub-Rack

DDE

VDFF

VABK1

VDABK1

BK1

Balance Chamber

RVFPE

TSD-S

MSBK1

VEBK1

VDEBK1

FBK1

FPE

ENDLF-SENDLF

VLA

LAFS

FBK2

VDABK2

VABK2

VEBK2

VDEBK2

SBS1

Air

VDA

FPA

BK2

MSBK2

RVDA

SBS2

LVD

RVFPA

UFP

RVUFP

Supply

KVABVA

Central Concentra te

KSS

SKKSSKBS

(Unit Rear)

Disinfectant

KSK

Acid Concentrate

FEP

BIC

VBKS

FBIC

RVBO*

VVB*

VEB

TSD

DF Sub-Rack

DBK*

Dialysate Outlet

Water Sub-Rack

Water Inlet

DMV

VVBE

BICLFTSBIC

TSE

NSVB

WT VB EK

RVK

RVB

WAB

BICP

VBICP*

TSH

Kt/V-UV*

TSHE VBKO*

BIC Concentrate

Supply

Central Bicarbonate

KSB

Disinfectant

Blood Venous

SPA

BKUS

Dialysate Flow 2

RVBU

Water

Housing

Options

AirConcentrate

Dialysate

Bicarbonate

Blood Arterial

Dialysate Flow 1

BA-TE-DE08C M.KAY

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2. Technical System Description 1/2010 2 - 27

2.19.4 Legend Flow Diagram

Abbreviation

BE BICLF BICP BICSS BK1 BK2 BL BPA BPV BVA DBK DDE DMV EK ENDLF ENDLF-S EP FB FBIC FBK1 FBK2 FEP FK FM FPA FPE FVD H HP KE KP KSB KSK KSS KVA LA LAFS LVD MSBK1 MSBK2 NSVB PA PBE PBS PDA PE

Bicarbonate Withdrawal Bicarbonate Conductivity Bicarbonate Pump Bicarbonate Rinsing Connection Sensor Balance Chamber 1 Balance Chamber 2 Blood Leak Detector Arterial Blood Pump Venous Blood Pump Bicarbonate Supply Connection (Central Supply) Throttle Bicarbonate Cartridge Holder Throttle Dialyser Inlet Pressure Reducer Valve Degassing Chamber END Conductivity END Conductivity Supervisor Degassing Pump Filter Bicarbonate Filter Bicarbonate Cartridge Filter Balance Chamber 1 Filter Balance Chamber 2 Filter Degassing Pump Filter Concentrate Flowmeter Outlet Flow Pump Inlet Flow Pump Filter from Dialysate Heater Heparin Syringe Pump Concentrate Withdrawal Concentrate Pump Bicarbonate Rod Concentrate Rod Concentrate Rinsing Connector Sensor Concentrate Supply Connector (Central Supply) Air Separator Air Separator Level Sensors Light Barrier Disinfection Valve Membrane Position Sensor Balance Chamber 1 Membrane Position Sensor Balance Chamber 2 Level Sensor Upline Tank Arterial Pressure Sensor Pressure Sensor Blood Inlet Blood Pressure Control Sensor Pressure Sensor Dialysate Outlet Degassing Pressure Sensor

Description

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2. Technical System Description 1/2010 2 - 28

Venous Pressure Sensor

PV RDV RVB RVDA RVFPA RVFPE RVK RFUFP SAD SAKA SAKV-SD SBS1 SBS2 TSBIC TSD TSDE TSD-S TSE TSH TSHE UFP VABK1 VABK2 VB VBICP VBKO VBKS VBP V.D. VD VDA VDABK1 VDABK2 VDE VDEBK1 VDEBK2 VEB VEBK1 VEBK2 VLA VVB VVBE VZ WA WT Z.D.

Venous Red Detector Throttle Bicarbonate Throttle Dialysate Valve Throttle Flow Pump Outlet Throttle Flow Pump Inlet Throttle Concentrate Throttle Ultrafiltration Pump Safety Air Detector Arterial Tubing Clamp Venous Tubing Clamp Currentless Closed Rinsing Bridge Connector Sensor 1 Rinsing Bridge Connector Sensor 2 Bicarbonate Temperature Sensor Dialysate Temperature Sensor Dialyser Inlet Temperature Sensor Dialysate Temperature Sensor Supervisor Degassing Temperature S ensor Thermal Fuse Heater Element Heater Inlet Temperature Sensor Ultrafiltration Pump Outlet Valve Balance Chamber 1 Outlet Valve Balance Chamber 2 Upline Tank Bicarbonate Pump Valve Bicarbonate Cartridge Holder Top Valve Bicarbonate Cartridge Holder Concentrate Rod Valve Bypass Valve Dialyser Coupling (from Dialysate) Disinfection Valve Dialyser Outlet Valve Dialyser Outlet Valve Balance Chamber 1 Dialyser Outlet Valve Balance Chamber 2 Dialyser Inlet Valve Dialyser Inlet Valve Balance Chamber 1 Dialyser Inlet Valve Balance Chamber 2 Degassing Bypass Valve Inlet Valve Balance Chamber 1 Inlet Valve Balance Chamber 2 Air Separator Valve Upline Tank Valve Upline Tank Inlet Valve Circulation Valve Water Block Heat Exchanger Dialyser Coupling (to Dialysate)

BA-TE-DE08C M.KAY

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2. Technical System Description 1/2010 2 - 29

2.20 Description Flow Diagram

2.20.1 Water Inlet Section with Water Block

The flow diagram can be divided into six sections:

Water Inlet Section with Water Block

•

Degassing Circuit with Temperatur e Sy stem

•

Dialysate Processing

•

Balance Chamber

•

Ultrafiltration

•

Rinsing Bridge

•

The water inlet section has the following components

Pressure Reducer Valve DMV

•

Upline Tank Inlet Valve VVVVVBE

•

Water Block WAB

•

NSVB

NSVB, Heat Exchanger WT

NSVBNSVB

WAB with integrated Upline Tank VB, Level Sensors Water Block

WABWAB

DMV

DMVDMV

VBE (2/2 way valve)

VBEVBE

WT, 2 double-stage Heater HHHH, Degassing Chamber EK

WTWT

EKEK

Wate r Inlet

DMV

VVBE

A D

TSHE

FEP

VEB

Dialysate Outlet

Pressure Reducer Valve DMV

Pressure Reducer Valve DMVPressure Reducer Valve DMV The pressure reducer valve DMV limits the pressure of the

inlet water (e.g. osmosis water) to 0.9 ±0.1 bar.

VLA

RVDA

SKBS

DBK*

NSVB

TSH

WAB

TSE

VBKO*

VVB*

TSBIC

VBICP*

Upline Tank Inlet Valve

Upline Tank Inlet Valve VVVVVBE

Upline Tank Inlet Valve Upline Tank Inlet Valve The valve VVBE is time-delayed controlled via the level sensor

NSVB

NSVB (top) in the upline tank VB

NSVBNSVB the dialysate flow.

Level Sensors Upline Tank NSVB

Level Sensors Upline Tank NSVBLevel Sensors Upline Tank NSVB The level sensors are mounted in the upline ta nk V B. NSVB

NSVB top:

NSVBNSVB closed - VVBE is closed

NSVB

NSVB bottom (monitoring low water level):

NSVBNSVB closed (alarm) - Water inlet is disturbed

- Heater is switched off – Pumps are stopped

Heat Exchanger WT

Heat Exchanger WTHeat Exchanger WT The cold inlet water is warmed up via the heat exchanger WT.

Thereby the heat consumption to heat up the water is reduced.

VBE

VBEVBE

VB. The delay time depends on

VBVB

Fig. : Water Inlet with Water Block

BA-TE-DE08C M.KAY

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RVBO*

VBKS

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Dialog

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2. Technical System Description 1/2010 2 - 30

2.20.2 Degassing Circuit with Temperature System

Degassing Bypass Valve VEB

Degassing Bypass Valve VEBDegassing Bypass Valve VEB

Degassing Pressure Sensor PE

Degassing Pressure Sensor PEDegassing Pressure Sensor PE

Degassing Pump EP

Degassing Pump EPDegassing Pump EP

The degassing circuit with temper a tur e sy stem has the following components:

Degassing Bypass Valve VEB

•

Degassing Pressure Sensor PE

•

Degassing Chamber EK

•

Degassing Pump EP

•

Thermal Fuse Heater TSH

•

Temperature Sensor Heater Inlet TSHE

•

Double-Stage Heater HHHH

•

Degassing Temperature Sensor TSE

•

The degassing bypass valve VEB, pressure sensor PE, degassing chamber EK and degassing pump EP produce and measure a negative pressure respectively. The negative pressure is produced to separate the dissolved gas from the water.

If the degassing bypass valve VEB is closed, the flow path is reduced by means of a bypass constriction (orifice, throttle principle) in the valve. VEB is opened during disinfection to avoid this constriction. The desired negative pressure is gained by controlling the degassing pump EP. The value of the negative pressure is approx. -500 mmHg and thus always higher than the lower pressure of the dialysate behind the dialyser. The degassing pump works with constant speed, which is determined by the dialysate flow, unless the negative pressure is insufficient. Then the speed of EP is increased.

EPEP

EKEK

TSH

TSHTSH

VEB

VEBVEB

PEPE

TSE

TSETSE

TSHE

TSHETSHE

Thermal Fuse Heater TSH

Thermal Fuse Heater TSHThermal Fuse Heater TSH

Degassing Temperature Sensor TSE

Degassing Temperature Sensor TSEDegassing Temperature Senso r TSE

Temperature Control

Temperature ControlTemperature Control

Wate r Inlet

DMV

VVBE

A D

TSHE

Dialysate Outlet

NSVB

TSH

Heater H

Heater HHeater H

TSE

WAB

DBK*

VBKO*

The heater H has an integrated thermal fuse TSH as a thermal cut-off. The temperature sensor TSE measures the actual temperature at the outlet of the heating.

The required heat output is determined with the temperature sensors TSE and TSHE.

A detailed description for the double-stage heater control is described in the paragraph for the switch mode power supply microcontroller SMPS-MC.

VLA

RVDA

SKBS

TSBIC

VBICP*

FEP

VEB

Fig. : Degassing Cir cuit with Temperature Syst em

BA-TE-DE08C M.KAY

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VVB*

RVBO*

VBKS

B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 31

2.20.3 Dialysate Processing

The dialysate processing has the following components:

Bicarbonate Concentrate Pump BICP

•

Bicarbonate Throttle RVB

•

Bicarbonate Temperature Sensor TSBIC

•

Bicarbonate Conductivity BICLF

•

Concentrate Pump KP

•

Concentrate Throttle RVK

•

END Conductivity ENDLF

•

END Conductivity Supervisor ENDLFS

•

Dialysate Temperature Sensor TSD

•

Dialysate Temperature Sensor Supervisor TSDS

•

Inlet Flow Pump FPE

•

Inlet Flow Pump Throttle RVFPE

•

Dialyser Inlet Temperature Sensor TSDE

•

The main components of the dialysate preparation are the bicarbonate concentrate pump BICP and the concentrate pump KP, with the conductivity cells BICLF and ENDLF and a flow pump FPE. The flow pump FPE delivers the dialysate. The bicarbonate concentrate, which is added via the bicarbonate pump BICP, is measured by the conductivity measurement cell BICLF. Thereby the pump can control the giv en conductivity set-point value.

KPKP

ENDLF

ENDLFENDLF

FPE

FPEFPE

RVB

RVBRVB

RVK

RVKRVK

BICLF

BICLFBICLF

ENDLFS

ENDLFSENDLFS

RVFPE

RVFPERVFPE

BICP

BICPBICP

TSD

TSDTSD

TSBIC

TSBICTSBIC

TSDE

TSDETSDE

TSDS

TSDSTSDS

TSBIC

BICLF

RVKRVB

TSD

The concentrate or acid concentrate addition has the same working principle. The nonreturn valves RVB and RVK stabilise the dosage of th e bicarbonate and concentrate.

The temperature sensors TSBIC, TSD and TSDE are responsible for:

the temperature compensation of the c o nductivity measurement and

•

the temperature measurement TSD after the addition of cold concentrate

•

(second measurement sensor for temperature system) and the temperature measurement TSDE directly before the dialysate leaves the

•

machine and thus for the compensation of the temperature loss.

The conductivity sensor ENDLFS is an independent monitoring unit (supervisor). The geometry of the ENDLFS sensor is different (but has the same cell constant) than the ENDLF sensor of the controller. Thereby a deposit on the sensor can be identified. The temperature compensation is carried out by the temperature sensor TSDS. The temperature sensor additionally monitors the dialysate flow temperature for the supervisor. The ENDLFS and TSDS sensors have no influence on the respective control.

The throttle RVFPE prevents a high pressure build-up and thus a bursting of tubing if the flow path is blocked behind FPE. If the set pressure is reached RVFPE is opened and the fluid can circulate.

RVFPE

TSD-S

ENDLF-SENDLF

FPE

VDEBK1

DDE

TSDE

VDE

BICP

Fig. : Dialysate Processing

BA-TE-DE08C M.KAY

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VEBK1

VDEBK2

VEBK2

BK1

MSBK1

BK2

MSBK2

B. Braun Avitum AG

Dialog

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2. Technical System Description 1/2010 2 - 32

2.20.4 Central Bicarbonate and Concentrate Supply (Option)

2.20.5 BIC Cartridge Holder (Option)

DBK

DBK Throttle Bicarbonate Cartridge Holder

DBKDBK

VBKO

VBKO Bicarbonate Cartridge Holder Top Valve

VBKOVBKO

VBKS

VBKS Bicarbonate Cartridge Holder Concentrate Rod Valve

VBKSVBKS

VBICP

VBICP Bicarbonate Pump Valve

VBICPVBICP

VVB

VVB Upline Tank Valve

VVBVVB

A canister or central supply can be selected via the bicarbonate and concentrate supply connection BVA and KVA.

The flow pump FPE guarantees a continuous control of the desired dialysate flow into the balance chambers.

The flow rate is determined by the filling time of the balance chamber. The flow pump FPE is controlled via the predetermined volume of the chamber and a continuous detection of the posi tio n o f the membr ane.

Throttle Bicarbonate Cartridge Holder

Throttle Bicarbonate Cartridge HolderThrottle Bicarbonate Cartridge Holder DBK ensures a constant pressure (approx. 300 mmHg) during the filling of the bicarbonate cartridge.

Bicarbonate Cartridge Holder Top Valve

Bicarbonate Cartridge Holder Top ValveBicarbonate Cartridge Holder Top Valve The bicarbonate cartridge is filled to the limit pressure (300 mmHg) after VBKO opens.

Bicarbonate Cartridge Holder Concentrate Rod Valve

Bicarbonate Cartridge Holder Concentrate Rod ValveBicarbonate Cartridge Holder Concentrate Rod Valve The bicarbonate cartridge is vented during preparation and in therapy, i.e. VBKO closes and VBKS opens for a short time. This is repeated in regular intervals during therapy. VBKS is opened after the end of the therapy to empty the bicarbonate cartridge.

Bicarbonate Pump Valve

Bicarbonate Pump ValveBicarbonate Pump Valve VBICP opens shortly after the BIC cartridge was filled, to rinse away the initial bicarbonate. VBICP switches the BIC pump in bypass after the end of the therapy to empty the bicarbonate cartridge.

Upline Tank Valve

Upline Tank ValveUpline Tank Valve VVB cuts off the main flow after the end of the therapy to empty the bicarbonate cartridge via FPE (VBICP and VBKS are opened).

RVFPE

DBK*

TSE

VBKO*

VVB*

RVBO*

RVBU

VBICP*

SPA

BKUS

RVB

FBIC

BICP

BVA

VBKS

TSD TSD-S

T T

BICLFTSBIC

RVK

ENDLF-SENDLF

FPE

Fig. : BIC Cartridge Holder (Option)

BA-TE-DE08C M.KAY

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2. Technical System Description 1/2010 2 - 33

2.20.6 Balance Chamber System

The balance chamber system has the following components:

Balance Chamber BK1

•

BK1

BK1BK1

2.20.7 Working Principle Balance Chamber System

Phase 1:

Balance Chamber BK2

•

Balance Chamber Dialyser Inlet Valve VDEBK1

•

Balance Chamber Inlet Valve VEBK1

•

Balance Chamber Memb r ane Position Sensor MSBK1

•

Balance Chamber Dialyser Outlet Valve VDABK1

•

Balance Chamber Outlet Valve VABK1

•

The measurement and control of the ultrafiltration rate is accomplished by the double balance chamber system and the ultrafiltration pump UFP.

Both balance chambers BK1 and BK2 are identical. The chambers have flexible membranes, which can be moved to both sides. The membranes divide the chambers into two sub-compartments. The flow direction is defined by the membranes and the eight solenoid valves. The position of the membranes is measured by inductive membrane position sensors MSBK1 and MSBK2. The membrane position sensors (ferrites) are connected to the membranes and each move in a respective coil MSBK1 and MSBK2.

The balance chamber BK1 is filled with dialysate at the beginning of ph ase 1. The membrane is in right position. The valves VDEBK1 and VDABK1 are opened. The balance chamber BK1 is filled by the outlet flow pump FPA with used dialysate, via valve VDABK1. Simult an e o u s l y t h e fre s h d i alys at e is removed from the balance chamber BK1 via valve VDEBK1. Phase 1 is completed and the membrane is in left position (see figure).

BK2

BK2BK2

VDEBK1 and VDEBK2

VDEBK1VDEBK1

VEBK1 and VEBK2

VEBK1VEBK1

VABK1 and VABK2

VABK1VABK1

VEBK2

VEBK2VEBK2

VDABK1 and VDABK2

VDABK1VDABK1

VABK2

VABK2VABK2

VDEBK2

VDEBK2VDEBK2

MSBK1 and MSBK2

MSBK1MSBK1

MSBK2

MSBK2MSBK2

VDABK2

VDABK2VDABK2

FPE

Fig. : Phase 1 Balance Chamber

VDEBK1

VEBK1

VDEBK2

VEBK2

MSBK1

MSBK2

The balance chamber BK2 is filled with fresh dialysate during this period. The used dialysate from the previous phase 2 is drained (see description phase 2).

BK1

DDE

VABK1

VBP

VDE

VDABK1

VABK2

VLA

LAFS

VDABK2

FBK2

PDA

BK2

UFP

FPA

RVFPA

VDA

open

closed

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 34

After phase 1 is completed there is an automatic switch to the filled balance

Phase 2:

chamber BK2 to obt ain a constant flow in the dialyse r. The complete cycle is repeated in phase 2, i.e. valves VDEBK2 and VDABK2 are opened. The balance chamber BK2 is filled via valve VDABK2. Simultaneously the dialysate is drained from the balance chamber BK2 via valve VDEBK2. Phase 2 is completed and the membrane is in left position (see figure).

Simultaneously the balance chamber BK1 is filled with fresh dialysate. Therefore valve VEBK1 is opened. Valve VABK1 is also opened, to initiate the flow path for the used dialysate to the drain. The membrane moves to the right position.

The outlet fluid volume is equal to the returned fluid volume, due to the closed balance chamber system

The fluid volume removed from the closed system via the ultrafiltration pump UFP is replaced from the blood in the dialyser and equals the precise ultrafiltration v o l ume.

The system is initialised in preparation, i.e. the membrane sensors are automatically calibrated and the speed of the flow pumps FPE and FPA are determined. Thus a synchronisation of the membranes is guaranteed, and the pump speeds for the desired flow are determined.

FPE

Fig. : Phase 2 Balance Chamber

VDEBK1

VEBK1

VDEBK2

VEBK2

MSBK1

MSBK2

BK1

BK2

DDE

VABK1

VDABK1

VABK2

VDABK2

UFP

FBK2

VLA

LAFS

FPA

RVFPA

VBP

VDA

VDE

PDA

open

closed

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 35

2.20.8 Ultrafiltration and Rinsing Bridge

The main flow path and bypass have the following components:

Dialyser Inlet Throttle DDE

•

Dialyser Inlet Valve VDE

•

Dialyser Outlet Valve VDA

•

Bypass Valve VBP

•

Outlet Flow Pump FPA

•

The flow path for the main flow and bypass are determined by the valves VDE, VDA and VBP. The built up flow from the flow pump FPA is stabilised by the throttle DDE. Valves VDE and VBP are closed for sequential therapy (ultrafiltration without dialysate flu id flow). The ultrafiltrate removal is carried out by the ultrafiltration pump UFP.

Further components are:

Red sensitive blood leak detector BL

•

Pressure sensor PDA which monitors the dialysate pressure (also used to

•

calculate TMP) Air separator LA with built in level sensors LAFS and air separator valve VLA

•

Throttle RVDA functions as a resistance to stabilise the flow of FPE

•

VBP

VBPVBP

VDE

VDEVDE

FPA

FPAFPA

DDE

DDEDDE

VDA

VDAVDA

Detection of Air in Air Separator LA

The throttle RVFPA prevents a high pressure build-up and thus a bursting of tubing if the flow path is blocked behind FPA. If the set pressure is reached RVFPA is opened and the fluid can circulate.

If air is detected in the air separator LA by the air separator level sensors LAFS, the balance chamber switches to free flow:

VEBK1 and VDEBK2 opened

•

VABK1/2 and VDABK1/2 closed

•

VLA is opened and air is removed with positive pressure from LA. VLA is closed once air is not detected anymore by LAFS. The balance chamber is switched to normal operation.

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 36

2.20.9

DMV

VVBE

VB WT

PE TSH

FEP

VEB

Chemical Thermal Disinfection P rogram

Phase 1

Phase 2

NSVB

TSHE

TSE

WAB

A D

BICP

RVB

The position of the couplings is checked by the sensors BICSS, KSS, SBS1 and SBS2. The machine starts to rinse as soon as the disinfection menu is entered. After the disinfection type is selected the machine will rinse for 3 minutes and preheat the system to 45

C. During this phase all pumps (EP, FPE, FPA, BICP, KP, UFP) run and the valves are s witched so that any residual concentrate is rinsed from the complete hydr aulic circuit.

The air separator LA is filled with water via VLA. The upline tank VB is emptied, until the bottom NSVB is on, which switches off the heater H (VVBE is closed).

RVFPE

TSD

RVK

BVA

TSD-S

ENDLFBICLFTSBIC

RVDA

BIC SS

FPE

SKKSSKBS

KSS

FKFB

ENDLF-S

VDEBK1

FBK1

VEBK1

MSBK1

VDEBK2

VEBK2

MSBK2

KVA

DDE

BK1

VABK1

VDABK1

VABK2

VDABK2

BK2

RVUFP

VLA

LAFS

FBK2

FPA

RVFPA

UFP

VDETSDE

VBP

PDA

VDA

SBS1

LVD

SBS2

PEV*

V.D.

FVD

SB1

SB2

Z.D.

Fig. : Phase 2

KSB KSK

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 37

DMV

VVBE

VB WT

PE TSH

A D

TSHE

FEP

VEB

Phase 3

With UFP running, a negative pressure of –100 mmHg is created at PDA. When this pressure is reached VD opens. The disinfectant is sucked into the hydraulic system by the UFP via the dialyser connector s. The circulation valve VZ is open and fluid flows into the upline tank of the water block WAB, because the throttle RVDA acts as a fo rward resistance. As soon as the co rrect volume is reached, the upline tank VB is filled up with fresh water (VVBE is controlled by NSVB).

RVFPE

NSVB

TSE

WAB

BICP

RVB

BVA

TSD

RVK

TSD-S

ENDLF-S

ENDLFBICLFTSBIC

RVDA

SKKSSKBS

BIC SS

KSS

FKFB

VDEBK1

FPE

FBK1

VEBK1

MSBK1

VDEBK2

VEBK2

MSBK2

KVA

DDE

BK1

VABK1

VDABK1

VABK2

VDABK2

BK2

RVUFP

VLA

LAFS

FBK2

FPA

RVFPA

UFP

VDETSDE

VBP

PDA

VDA

SBS1

LVD

SBS2

PEV*

V.D.

FVD

SB1

SB2

Z.D.

Fig. : Phase 3

Phase 4

Phase 5

Phase 6

KSB KSK

The machine starts to recirculate the fluid, heating the system up to the desired temperature (e.g. 83

C). Once this temperature is reached and a desired

conductivity is re a ched (e.g. 2.2 mS/cm) the disinfec ti o n timer starts. The machine recirculates the fluid, monitoring the temperature and

conductivity until the disinfection time is reached. There is no flow of fluid to the drain during suction, heat-up and circulation. Then the machine starts with the VBICP test. The machine checks whether VVB and VBICP open and close properly. During the first step of this test VVB and VBICP are closed. With FPE and FPA still running this causes a negative pressure at PDA. VBICP then opens, causing a rapid increase in pressure at PDA.

The machine then starts to rinse with VZ closed until the rinsing time is reached, and the temperature has decreased below 40

C and conductivity is below 0.1 mS/cm. Then the machine gives a message that asks the user to confirm that the machine is free of disinfectant and the disinfection is completed.

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2.21 Block Diagram

Touch Controller

Board TCB

2. Technical System Description 1/2010 2 - 38

Communication

Backlight In verte r

Touch Screen

Optical Status

Display Board

OSDB

LC Display

Board BIB

Optical Status

Display Board

OSDB

Service USB Stick

DCI*

Compact Flash

ABPM *

BSL *

DCI *

COM4 LCD Port

COM3

COM1

Top Level Controller

(Motherboard)

COM2

Parallel

TLC

Port

Speaker

IDE

USB1 USB2 USB3

USB

4-8

Ethernet

DIABUS

Front Panel Board

BICPOS TSHE

KPPOS UFPOS BKUS*

SBS1

SBS2 BPA_IMP BPA_DIR

BPV_IMP BPV_DIR

SUP

Sensors

Controller

Sensors

Controller/SUP

NSVB

BICSS

MSBK1

MSBK2

RDV

Sensors

BPADS TSD-S BPVDS ENDLF-S

Seria l B US

KSS PBS

SAD

Analog

Sensors

Board

Controller

(LLA)

SUP

Sensors

TSBIC

TSDE

Sensors

BICLF

Controller

ENDLF

LAFS

BPA BPV

FPA

BLD

Controller/SUP

Sensors

FPE

START

STOP

Card Reader*

Kt/V-UV*

Crit-Line*

Card

SUPBUS

TSE

TSD

PBE

PDA

FPB

Top Leve l

Low Level

Basic Boa rd

BICP

KP UFP LRP

Mains

Voltage

Fig. : Block Diagram

PBM

Power

Board

Motors

Mains Switch

PBV

Power Board

Valves

SAKV

SMPS-MC

Switch Mode Power Supply

Microcontroller

VDEBK1VVBE VDEBK2VEB VDABK1VLA

VDABK2VDE

VEBK1VDA

VEBK2VBP VABK1VVB* VABK2VBICP*

VBTVBKS* VPVVBKO* VPEVD VPU VPD

SAKA

VPA

Heparin Pump

Compact

HOB

* HDF

Online

Board

* Battery

HP LS

KRALO

KOLB

VSAA

VBE VDFF VSAE VSB

PSAUS

PSABFS

FEDFFS

FEHDFS

* Options

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 39

2.21.1 Legend Block Diagram Digital Board DB

Supervisor

Controller/Supervisor

BPA BPV

FPA

FPE

BICPOS

KPPOS UPPOS

BKUS

SBS1 SBS2

BPA_IMP

BPA_DIR

BPV_IMP

BPV_DIR

Arterial Blood Pump Venous Blood Pump Degassing Pump Outlet Flow Pump Inlet Flow Pump

Bicarbonate Pump Position Sensor Concentrate Pump Position Se nsor UF Pump Position Sensor

Bottom Bicarbonate Cartridge Sensor Rinsing Bridge Connector Sensor 1 Rinsing Bridge Connector Sensor 2 Arterial Blood Pump Motor Hall Sensor Arterial Blood Pump Direction Venous Blood Pump Motor Hall Sensor Venous Blood Pump Direction

Analog Board AB

Controller

NSVB

BICSS

KSS MSBK1 MSBK2

RDV

SAD BPADS BPVDS

Controller

PBS

TSHE

TSE

TSBIC

TSD

TSDE

BICLF

ENDLF

LAFS

Level Sensor Upline Tank Bicarbonate Rinsing Connec ti o n Se nsor Concentrate Rinsing Connector S enso r Membrane Position Sensor Balance Chamber 1 Membrane Position Sensor Balance Chamber 2 Venous Red Detector Safety Air Detector Arterial Blood Pump Cover Switch Venous Blood Pump Cover Switch

Pressure Single Needle Heater Inlet Temperature Sensor Degassing Temperature Sensor Bicarbonate Temperature Sensor Dialysate Temperature Sensor Dialyser Inlet Temperature Sensor Bicarbonate Conductivity END Conductivity Degassing Pressure Sensor Air Separator Level Sensors

BA-TE-DE08C M.KAY

Supervisor

TSD-S

ENDLF-S

Dialog+ SW 9xx_sm_C ha pter 2_1-2010.doc/pdf < 100329> yymmdd

Dialysate Temperature Sensor Supervisor END Conductivity Supervisor

B. Braun Avitum AG

Dialog

SW 9.xx

Controller/Supervisor

Power Board Motors PBM

Power Board Valves PBV

2. Technical System Description 1/2010 2 - 40

BLD PBE

PDA

BICP

UFP

LRP

VVBE

VEB

VLA

VDE

VDA

VBP

VVB

VBICP

VBKS

VBKO

VZ VDEBK1 VDEBK2 VDABK1 VDABK2

VEBK1

VEBK2 VABK1 VABK2

VBT

VPV

VPE VPU VPD VPA

SAKV

SAKA

Blood Leak Detector Pressure Sensor Arterial Pressure Sensor Venous Pressure Sensor Pressure Sensor Dialysate Outlet

Bicarbonate Pump Concentrate Pump Ultrafiltration Pump Level Regulation Pump

Upline Tank Inlet Valve Degassing Bypass Valve Air Separator Valve Dialyser Inlet Valve Dialyser Outlet Valve Bypass Valve Upline Tank Valve BIC Pump Valve BIC Concentrate Suction Rod Valve Top BIC Cartridge Valve Disinfection Valve Circulation Valve Dialyser Inlet Valve Balance Chamber 1 Dialyser Inlet Valve Balance Chamber 2 Dialyser Outlet Valve Balance Chamber 1 Dialyser Outlet Valve Balance Chamber 2 Inlet Valve Balance Chamber 1 Inlet Valve Balance Chamber 2 Outlet Valve Balance Chamber 1 Outlet Valve Balance Chamber 2 Blood Side Test Pressure Sensor Valve Venous Pressure Sensor Val v e Inlet Pressure Sensor Valve Up Pressure Sensor Valve Down Pressure Sensor Valve Arterial Pressure Sensor Valve Venous Tubing Clamp Arterial Tubing Clamp

Heparin Pump Compact

BA-TE-DE08C M.KAY

Dialog+ SW 9xx_sm_C ha pter 2_1-2010.doc/pdf < 100329> yymmdd

KRALO

KOLB

Heparin Pump Compact Light Barrier Speed Monitoring Interlocking Sensor Syringe Plunger Sensor

B. Braun Avitum AG

Dialog

SW 9.xx

HDF Online Board HOB

2. Technical System Description 1/2010 2 - 41

VSAA

VBE

VDFF

VSAE

VSB

PSAUS

PSABFS

FEDFFS

FEHDFS

Substitution Connection Outlet Valve (drain) Filter Vent Valve DF Filter Valve Substitution Connection Inlet Valve Substitution Bypass Valve Port Substitution Outlet Sensor Port Substitution Drain Sensor DF Filter Detection Sensor HD Filter Detection Sensor

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 42

2.22 Switch Mode Power Supply Microcontroller SMPS-MC

2.22.1 Block Diagram SMPS-MC

+5VD

+12VD

+12VA

-12VD

+12VD

-12VA

F301

F302

- Ext. - P14- - Motherboard

F303

F304

- ABPM - P7

- DSI - P8

20..30Vdc

PFC

Power

Factor

Correction

F_bat

(Option)

Battery 24V

GND

Forward Converter

I_bat

Secondary SidePrimary Side

Signals

Microcontroller

Buzzer

Hardware

Watchdog

(EMC)

Filter

T6.25A

Fig. : Block Diagram Switch Mode Power Supply Microcontroller SMPS-MC

BA-TE-DE08C M.KAY

Dialog+ SW 9xx_sm_C ha pter 2_1-2010.doc/pdf < 100329> yymmdd

T6.25A

F5B

Mains

LH2

Double-

F12A (230V)

F5A/F5B

T6.25A (230V)

F5A

Stage

F20A (110V)

F12A ( 110V)

PE1

LH1

Heater

B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 43

2.22.2 System Integration SMPS-MC

/PERSR_N

/AKKU_OK

D24OK

+5VD

+12VD

-12VD

-12VAN

+12VAN

24VL

24VGB

24VGD

B24O K

PGD

+5VG

Power

Battery Option

Mains Switch

Fan

24 V ControlHardware

Battery

Low Voltage Differential

Sig nal Adapter

TLC

Secondary Side

24V

Watchdog

Micro-

Power

(Motherboard)

LVDS

Top Level Contr olle r

Messages Output

Machine MonitoringServie Ju mper

5 V

2 x 1F

Control for Battery, Buzzer, Clock

Controlle r

Buzzer

Aux. Voltage

DGND /B24OFF WD_S AKKU_EN D24OFF /REM AKAL_S AKAL

X101

Watchdog

ail

Primary Side

U Contro l

max

SMPS-MC

Microcontroller

Heater Control Input

DGND

Switch Mode Power Supply

Heater

/H_PROG H_DCLK H_DIN

Hea t er

PE1

LH1

LH2

3 x 152 C

Thermal Fuses

900 W 900 W

TCB

Touch Controller Board

TFT D i splay

BIB

Inverter

Backlight

Board

FPB

Front Panel Board

Mains Input

Charge LED

Fig. : System Integration

BA-TE-DE08C M.KAY

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Centra l Earth

B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 44

2.22.3 Component Layout SMPS-MC

C19

: P6

: P5

X1.8 X1.3 X1.2

X1.1 X1.4

PE1LH1 LH2 L N PE P E

X1.5

X1.7 X1.6

F5A

C18

F5B

: P10

: P8

: P5

: P4

F1 T6.25A 6.3x32 (X1.1: L)

F2 T6.25A 6.3x32 (X1.2: N)

F5A 110/120V: F12A 6.3x32 (X1.6: HZG1-L)

F401

H401

P12

ontroller works correctly

LED H900 Operating Status

230V: T6.25A 6.3x32 (X1.6: HZG1-L)

F5B 110/120V: F12A 6.3x32 (X1.7: HZG2-L)

230V: T6.25A 6.3x32 (X1.7: HZG2-L)

F6 110/120V: F20A 6.3x32 (X1.5: HZG-N)

230V: F12A 6.3x32 (X1.5: HZG-N)

F301 T3.15A TR5 (+5VD1)

F302 T5.0A TR5 (+5VD2)

F303 T3.15A TR5 (+5VD3)

F304 T3.15A TR5 (+5VD4)

F401 T3.15A TR5 (+12VD1)

F402 T5.00A TR5 (+12VD2)

F403 T1.25A TR5 (+12VA)

F60 0 M1 0.0 0A 6.3x32 (+24VL)

F601 T3.15A TR5 (+24VGB)

F602 T3.15A TR5 (+24VGD)

X101 Service Jumper

H600H403

H104

F303

H303

H300

F301

F302

F304

H301

H302

H304

P10

H601

F601

F602

H602

H402

F600

F402

F403

X103 /EN_EXT

GNDAKKU

XP3.2

X104 Charge Current Battery Option

(left:100%/default: right:50%)

LED off Microcontroller does not work

LED flashes Microcontroller has detected

LED flashes with Microc

approx. 2 Hz

with 5 .. 10 Hz an error

Fan

X100

X903

Goldcap

1F Capacitor

Status

LED Operating

Service

Jumper

C114

C115

X104

H900

P7 P8

P11

X101

+24VAKKU

XP3.1

X103

P14

D900

Options

Fig. : Layout SMPS-MC

BA-TE-DE08C M.KAY

+24 VL

Voltages

Motherboard

Dialog+ SW 9xx_sm_C ha pter 2_1-2010.doc/pdf < 100329> yymmdd

Voltages

+24 VGB

+24 VGD

+5 VD2

Voltages

+12 VD1/2

Battery

+12 VA

Battery

/EN_EXT

Option DSI

Charge Current

Option ABPM

Mains Switch/Fan

EXT_ON

Signals

Supervisor)

(Controller/

Digital Board

from Low Level to

Power Supply Control

B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 45

2.22.4 Wiring Diagram SMPS-MC with Battery Option

TFT Display

(right)

F401

H401

H303

H301

H302

H304

H601

H602

H402

F303

F301

F302

F304

F601

F602

F402

F403

P12

P10

Battery

2 x 12V

=blue

=brown

Pin 1/2

Charge LE D

Fig. : Wiring Diagram SMPS-MC with Battery Option

XP3.2 XP3.1

X103

GNDAKKU +24VAKKU

P14

X903

X101

X104

P7 P8

P11

H900

J5J3

H104

H300

Switch Mode Power Supply

F600

C1 15

C1 14

H600H403

X100

Microcontroller

Charge LED

SMPS-MC

F5B

F5A

(left)

F2 F1

X1.3

X1.1

X1.7

X1.6

X1.2

X1.5

X1.4

X1.8

BA-TE-DE08C M.KAY

2 x 12 V, 7 Ah

Battery

Fuse for Battery

10 AT (5x20), breaking c apacity 1500 A, 150 Vdc

Jumper X104 Charge Current for Batteries

Default: 50 % (right posi ti o n)

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B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 46

2.22.5 Description SMPS-MC

The switch mode power supply microcontroller SMPS-MC is used in Dialog+ machines with software ≥ 9.xx.

Basic Components SMPS-MC

SMPS-MC

Mains input, filter (EMC)

•

Bridge rectifier

•

PFC converter

•

DC/DC converter

•

Transformer

•

24 VL output (protected via F 600)

•

24 VGB output (switched via K 3, p r otected via F601)

•

24 VGD output (switched via K 4, pr o tec ted v i a F602)

•

DC/DC converter 24 V/+5 V (pro tec ted v i a F301/F302/F303/F304)

•

DC/DC converter 24 V/+12 V (pro tec ted v i a F401/F402/F403)

•

DC/DC converter 24 V/-12 V (electro ni c ally protected and via sol d er ed f use

•

F500)

Heater power circuit tri a c V 29/V 30

•

Microcontroller ( D 900) for monitoring and heater c o ntr o l

•

Signal interface P2

•

Power connectors to the system components P4 ... P12

•

Battery screw terminal to 24 V P3

•

The SMPS-MC (Switch Mode Power Supply MicroController) is assembled in the rear door. The primary triggered switch mode power supply generates the following voltages on the secondary side: +5 V (5 V = 5 .2 V); ±12 V and 24 V (24 V = 21.5 ... 29.07 V). The primary side has a wide range input for 120/230/240 V ± 10 %. The SMPS-MC is not backwards compatible to the switch mode power supply SMPS.

Battery Option

Mains Volta ge

Mains Switch ON/OFF

Voltages

The battery option is available in the machine ex works and can also be retrofitted. The blood side functions in therapy can be maintained with a battery supply (option) in case of a power failure. The charging circuit is integrated in the SMPS-MC and includes a deep discharge protection.

120/230/240 V ± 10 %, 50/60 Hz If the Dialog+ is switched off via the

the machine is in standby mode, e.g. the Dialog+ can be switched on and off via the disinfection program. The Dialog+ is only disconnected from mains if the mains plug is pu lled out of the mains receptacle.

Switch-off in Therapy

The buzzer is activated three times if the Dialog+ is switched off in therapy.

Mains Failure

The Dialog+ (with SMPS-MC) can be switched off and on again in battery operation approx. 16 min after mains failure.

+5 VC Controller power supply +5 VD: Digital +5 VG: buffered (generated from +12 VH) +12 VH: Aux. voltage

12 VAN: Analog

12 VD: Digital

+24 VGB: Switched blood side +24 VGD: Switched dialysate side +24 VL: Power (uncontrolled) GNDAN: GND analog GNDD: GND digital GNDH: GND aux. voltage GNDL: GND power

Automatic Switch-Off

function in therapy,

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

2. Technical System Description 1/2010 2 - 47

Double-Stage Heater and

Microcontroller

% 80 60

1800W

LLC 40%

60 4040 20

720W = 720W

1800W

80 80

LLC 6 0 %

60 40

1080W = 180W + 900W

(>900W: H2 = ON)

Hardware Watchdog

(see also LED H900)

LED H900 Operating Status 3 Modes:

Battery Management

+12 V Voltage

H1 H2

900W900W

80%

OFF

H1 H2

900W900W

20%

24 V Outputs

+5 V Voltage

The SMPS-MC controls the double-stage heater H1/H2 (2 x 900 W). The first heater circuit (heater H1, 900 W) is driven in 2 % steps. The second heater is switched with max. power (900 W) if 50% of H1 is reached. H1 is then controlled with half-wave-shapes, generated by the microcontroller the SMPS-MC.

Example: Set value of LLC = 40 % (based on 1800 W)

H1 = 80 % (based on 900 W)

•

H2 = switched off permanently

•

Set value of LLC = 60 % (based on 1800 W)

H1 = 20 % (based on 900 W)

•

H2 = switched on permanently

•

The microcontroller converts the predefined heater power from LLC into bit patterns (1 bit corresponds to a mains voltage half cycle) to control both heaters.

The hardware watchdog the microcontroller fails, i.e. the buzzer is activated, the heater and both voltages +24VGB/+24 VGD are switched off. The staff call is activated if present.

LED off : Microcontroller is not working LED flashes with 5 ... 10 Hz: Microcontroller has detected an error LED flashes with approx. 2 Hz: Microcontroller is working correctly

The 24 V of the main converter suppl ie s the f ol l owi ng circuits:

24 VL via fuse F600

•

24 VGB via fuse F601 and r el ay K3

•

24 VGD via fuse F602 and Rel a y K4

•

The SMPS-MC has a battery management, with the following compo nents:

Screw terminal XP3.1 (+) and XP3.2 (-) for batteries

•

Protection against incorrect polarity

•

Electronic connection

•

Deep discharge protection TES

•

Charging current regulator

•

Battery full detection

•

Shut-down circuit for the battery test

•

Enable signal

•

All output voltages are maintained during a power failure if the signal

AKKU_EN

also present. The battery is charged if mains voltage is present. The charging is performed via a body diode even without battery from deep discharge by disconnecting the battery source from the circuit at a voltage < 22 V ±0.5 V via a MOSFETT switch.

The 5 V DC/DC converter generates the 5 V voltage from the 24 V. The overvoltage protection circuit (crowbar) is triggered at 5.75 V ± 250 mV. A reset of the overvoltage protection circuit is possible only by switching the machine off and on again. The solder ed f use F 300 di sconnects the 24 V in case of a short circuit in the DC/DC converter.

A DC/DC converter generates the –12 V voltage from the 24 V. The soldered fuse F500 disconnects the 24 V in case of a short circuit in the DC/DC converter.

was set prior to the power failure. The secondary auxiliary voltage is

HW-WD

AKKU_EN

switches the SMPS-MC in a safe condition if

AKKU_EN

. A comparator protects the

D900

from

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

2.22.6 Fuses

SW 9.xx

2. Technical System Description 1/2010 2 - 48

Fuse Voltage

F1 F2

F5A

F5B

F301

F302 F303

F304 F401

F402

F403

F600

F601

F602

(Mains Input)

(Heater 1, 900 W)

(Heater 2, 900 W)

(Heater)

+5 VD1 3.15 A (TR5)

+5 VD2 +5 VD3

+5 VD4

+12 VD1

+12 VD2 5 A (TR5)

+12 VD3 1.25 A (TR5)

+24 VL 10 A (6.3 x 32)

+24 VGB 3.15 A (TR5)

+24 VGD 3.15 A (TR5)

Rated Fuse Value

Fuse Type

6.25 A

(6.3 x 32)

6.25 A

(6.3 x 32)

12 A (110/120 V)

6.25 A (230 V) (6.3 x 32)

12 A (110/120 V)

6.25 A (230 V) (6.3 x 32)

20 A (110/120 V)

12 A (230 V)

(6.3 x 32)

5 A (TR5)

3.15 A (TR5)

Connector

X1.1 X1.2 X1.6

X1.7

X1.5

P4/1 P4/4

P6/1 P11/1 P12/1 P14/6 P5/10 P10/1 P10/4 P10/7

P7/1

P8/1 P12/2

X100/1

P5/4

P7/4

P8/4

P9/5

P9/6

P10/10 P10/14

P11/2

P4/7

P5/1

P7/7

P8/7 P12/4 P4/10 P4/13

P5/8

P12/10

P4/11 P4/14

P5/7

P12/13

P4/12 P4/15

P12/14

BA-TE-DE08C M.KAY

Note:

Soldered fuses (e.g. F300 or F500) must not be changed if they are defective, i.e. the complete SMPS-MC must be exchanged.

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B. Braun Avitum AG

Dialog

2.22.7 Signals

SW 9.xx

2. Technical System Description 1/2010 2 - 49

AKAL

AKAL_S

AKKU_EN

AKKU_LADEN

/AKKU_OK

B24OFF

B24OK

D24OFF

D24OK

/DIR_ON

/EXT_ON

EXT_STATE

H_DCLK

H_DIN

/H_PROG

/MSWITCH

PERSR_N

/REM

WD_S

Audible alarm (LLC) Audible alarm (LLS) Enable battery operation (possible in therapy mode only) Signal for external LED (on front panel board) – charging of battery Load status of the battery +24 VGB ON/OFF (LLS) +24VGB OK +24 VGD ON/OFF (LLS) +24VGD OK Jumper X101 – is used to switch on the power supply without using the

signal and deactivates the alarms. (The watchdog signal for the function of the heater (

The machine can be switched on with this signal (see menu

Option

Status for external switch-on possibility (e.g. central disinfection), simultaneously input and output; the signal is looped through (connector P14/3 = input).

Clock signal for heater data from LLC. The signal and is generated by the LLC. The at

H_DIN

0, 1

The

H_DIN

to the microcontroller (data to control the hea ter) .

0 1

Programming mode for heater data. The signal and is generated by the LLC.

0 1

Mains switch Staff call from SMPS-MC Power fail (power failure)

Remote signal of LLC (clock on digital board) Watchdog LLS

) is still required to drive the heater.)

H_DIN

: external ON).

H_DCLK

to the microcontroller.

Data clock

signal is an open-collector signal, is generated by the LLC and sent

Half wave of mains voltage: heater switched off Half wave of mains voltage: heater switched on

/H_PROG

Programming mode No programming mode

Signal is an open-collector

Signal is used to send the data

signal is an open-collector

/REM

1.26 Battery

2.22.8 Internal Signals

BA-TE-DE08C M.KAY

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/PF

Watchdog

Power fail for the power supply monitoring A watchdog is integrated to prevent a permanent unintentional drive of the

heater in case of an LLC reset. The watchdog is retriggered by the LLC with < 2 s. The the heater for t = 10 s after the switch-on of the switch mode power supply.

The watchdog has no safety function and is therefore not tested before the therapy starts.

signal is used for triggering. The watchdog prevents a drive of

H_DIN

B. Braun Avitum AG

Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 1

Table of Content s Page

3. Self Test SW 9.xx

3.1 Microprocessor Unit MPU Test from Controller/Supervisor

3.2 Status Self Test in Service Overview

3.2.1 Set-Up Low Level Controller LLC Test Codes 3-7

3.2.2 Set-Up Low Level Supervisor LLS Test Codes 3-7

3.2.3 Example LLC/LLS Test Codes for Blood Leak Detector 3-8

3.2.4 Overview Test Codes 3-8

3.3 Self Tests in Preparation SW 9.XX Switch Mode Power Supply Microcontroller SMPS-MC

3.3.1 Service Mode (DIR_ON) 3-9

3.3.2 Battery 3-9

3.3.3 EEPROM 3-10

3.3.4 Buzzer Test via LLS 3-10

3.3.5 Alarm System 3-11

3-5 3-5 3-6

3-9

3.3.6 Monitoring of Analog Voltage ±12 V

3.3.7 Blood Leak Detector 3-12

3.3.8 DFS Pressure Test (Table) 3-13

3.3.8.1 DFS Pressure Test 3-16

3.3.8.2 Membrane Movement/Pressure Build-up VDABK 3-17

3.3.8.3 Pressure Reduction VDABK with UFP 3-18

3.3.8.4 VBP Test 3-19

3.3.8.5 VDE/VDA Test 3-20

3.3.8.6 Pressure Build-up VDABK 3-21

3.3.8.7 Pressure Reduction Membrane Test with UFP 3-22

3.3.8.8 Membrane Test 3-23

3.3.8.9 Pressure Build-up VABK 3-24

3.3.8.10 Membrane Movement to Inlet Side 3-25

3.3.8.11 Pressure Reduction VABK with UFP 3-26

3-12

BA-TE-DE08C M.KAY

3.3.8.12 VEBK Test 3-27

3.3.8.13 Pressure Reduction 3-28

3.3.9 Integrity Test HDF Online 3-29

3.3.10 UF Pump 3-31

3.3.11 Conductivity 3-32

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B. Braun Avitum AG

Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 2

3.3.12 Temperature TSD 3-32

3.3.13 SAD Level Test 3-33

3.3.14 SAD Counter Test 3-33

3.3.15 Equality Test for Blood Side Pressure Sensors 3-34

3.3.16 Pressure Test Substitution Line S-Online HDF Online 3-35

3.3.17 Blood Side Pressure Retention Test 3-36

3.3.18 Disinfection Valve VD 3-37

3.4 LX800 Motherboard

3.4.1 IDE Interface LX800 Motherboard 3-39

3.4.2 COM Ports LX800 Motherboard 3-39

3.4.3 USB Ports LX800 Motherboard 3-39

3.4.4 Detection/Boot Sequence from Bootable USB Sticks 3-40

3.4.5 BIOS Settings for LX800 Motherboard 3-41

3.4.5.1 Standard CMOS Features 3-42

3.4.5.2 Advanced BIOS Features 3-42

3.4.5.3 Advanced Chipset Features 3-42

3.4.5.4 Integrated Peripherals 3-43

3.4.5.5 Power Management Setup 3-43

3.4.5.6 PnP/PCI Configuration 3-43

3.4.5.7 PC Health Status 3-44

3.4.5.8 Change Parameters in CMOS Setup 3-44

3-38

3.5 Installation Software 9.xx

3.5.1 Document Customer Specific Default Values 3-46

3.5.2 Installation Software LLC 9.xx and LLS 9.xx with USB Stick 3-47

3.5.3 Installation Software TLC 9.xx with USB Stick 3-49

3.5.4 Boot Machine /Check Version Number 3-53

3.5.5 Select Options 3-53

3.5.6 Enter Customer Specific Default Values 3-53

3.5.7 Enter Specific Parameters 3-54

3.5.8 Self Test 3-55

3.5.9 Test Run 3-55

3.6 Field Service Utilities FSU

3.6.1 FSU Directories and Subdirectories 3-56

3.6.2 Start Field Service Utility FSU 3-57

3.6.3 Set-Up FSU Main Menu 3-58

3-46

3-56

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 3

3.6.3.1 Hardware Keys for FSU 3-59

3.6.4 Set System Version Number 3-60

3.6.5 Set Working Time Counter (WTC) 3-61

3.6.6 Kill Masterboot Record 3-62

3.6.7 Write Utilities 3-64

3.6.7.1 Write Languages 3-64

3.6.7.2 Write Calibration Data 3-66

3.6.7.3 Write System Configuration 3-69

3.6.7.4 Undo Last Written 3-72

3.6.8 USB Stick Self Test 3-73

3.6.9 Card Reader Read/Write Utilities 3-74

3.6.9.1 Select Menu of Card Reader Commands 3-74

3.6.9.2

3.6.9.3 Write Card Image 3-76

3.6.9.4 Read Patient Diskette 3-77

3.6.9.5 Write Patient Diskette to Card 3-78

3.6.9.6 Read Patient Card 3-79

3.6.9.7 Write Patient Card 3-80

3.6.9.8

3.6.10 Read/Get Error Utilities 3-83

3.6.10.1 Read System Configuration 3-83

3.6.10.2 Read Calibration Data 3-85

3.6.10.3 Read All Trends 3-87

3.6.10.4 Read Screenshots 3-89

3.6.10.5 Get Error (ErrorDisk) 3-91

3.6.11 FSU Handling of Errors 3-93

Read Card Image 3-75

Remove All Patient Data 3-81

BA-TE-DE08C M.KAY

3.6.12 Examination of Results 3-93

3.6.13 Troubleshooting USB Stick 3-94

3.6.13.1 Field Service Utility Menu with Failed CRC Check 3-94

3.7 Default Table for SW 9.xx

3.8 Measures after Repair

3.8.1 Repair Matrix 3-103

3.8.2 Tests and Measures to be Executed 3-104

3.8.2.1 Install Software 3-104

3.8.2.2 Check System Configuration, Production Report and Set if Necessary

Dialog+ SW 9xx_sm_C ha pter 3_1-2010.doc/pdf < 100329> yymmdd

3-95

3-103

3-104

B. Braun Avitum AG

Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 4

3.8.2.3 Self Test 3-105

3.8.2.4 Conductivity Test Run, Temperature Comparison Measurement

3.8.2.5 Test Run UF Comparison Measurement 3-105

3.8.2.6 Test Run 3-105

3.8.2.7 Electrical Safety Check 3-106

3.8.2.8 Perform Disinfection after Repair 3-106

3.8.2.9 Document the Executed Activities 3-106

3.8.3 Execution Protocol 3-107

3-105

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 5

3. Self Test SW 9.xx

3.1 Microprocessor Unit MPU Test from Controller/Supervisor

The microprocessor unit MPU of the controller and supervisor are checked. The function of the internal MPU registers, flags a nd stac ks is tested.

MPU Test Supervisor

MPU Test Controller

Flag Test Set and Reset Capa bility

Stack Test

Reactions in Case of an Error

of the MPU Tes t

The MPU test is performed in therapy mode and service mode after switch-on prior to the RAM and ROM test.

The MPU test is performed during the boot phase after the RAM and ROM test. The operating system is not active in this phase.

The following tests are performed:

Read-write capability of the registers

•

Cross-talk between the single bits

•

Address ability of the registers

•

Crosstalk between single words

•

The test checks whet her the flag can be set and reset corre ctly according to defined conditions.

Query Capability

The test checks whether the correctly set flags can also be evaluated correctly . The function of the stack is tested by storing and reloading/reading a test

pattern.

Controller

If an error is detected during the MPU te st the TLC terminates the start procedure – therapy can not be started. The error message is displayed in the TSM service program:

Bit 7, BIOS init. error

•

Bit 8, Error in MPU test

•

Supervisor

If an error is detected during the MPU test the following alarms are displayed:

In Therapy – Therapy Selection:

• Hardware error RAM/ROM (SUP)

In TSM Service Program:

• Error in MPU test

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 6

3.2. Status Self Test in Service Overview

Display LLC/LLS Test Codes

in Status Self Test

Water Tank

Water TankWater Tank

VVBE: OPENED/CLOSED NSVB: HIGH/LOW

Degassing

DegassingDegassing

EP: XXXX rpm VEB: OPEN/CLOSED PE: XXX mmHg TSE: XX.X oC TSHE: XX.X oC

Heater

HeaterHeater

HEATER: XX.X %

Air Separator

Air SeparatorAir Separator

LAFSO: NO AIR/AIR LAFSU: NO AIR/AIR VLA: OPEN/CLOSED

Temperature

TemperatureTemperature

TSE: XX.X oC TSBIC: XX.X oC TSD: XX.X oC TSD_S: XX.X oC TSDE: XX.X oC

Conductivity

ConductivityConductivity

BICLF: X.X mS/cm ENDLF: XX.X mS/cm ENDLF_S: XX.X mS/cm BICP: XX rpm BICP_S: XX rpm BIC-Ratio: XX.X BIC-Ratio_S: XX.X KP: XX rpm KP_S: XX rpm END-Ratio: XX.X END-Ratio_S: XX.X

The test codes for the self test are displayed by LLC and LLS in the

on the first page of the service overview (in therapy).

Test

Balance Chamber

Balance ChamberBalance Chamber

MSBK1: XXXXX MSBK2: XXXXX VEBK1_S: OPEN/CLOSED VABK1_S: OPEN/CLOSED VDEBK2_S: OPEN/CLOSED VDABK2_S: OPEN/CLOSED VEBK2_S: OPEN/CLOSED VABK2_S: OPEN/CLOSED VDEBK1_S: OPEN/CLOSED VDABK1_S: OPEN/CLOSED

Flow (Dialysate Fluid)

Flow (Dialysate Fluid)Flow (Dialysate Fluid)

FPE: XXXX rpm FPA: XXXX rpm FMD: XXX ml/min FMD_S XXX ml/min

Valves (Bypass)

Valves (Bypass)Valves (Bypass)

VBP: OPEN/CLOSED VBP_S: OPEN/CLOSED VDE: OPEN/CLOSED VDE_S: OPEN/CLOSED VDA: OPEN/CLOSED VDA_S: OPEN/CLOSED

Valves (

V al v es ( Disinfection)

Valves (Valves (

VZ: OPEN/CLOSED VD OPEN/CLOSED VD_S OPEN/CLOSED

BL: X.XX ‰ BL_S: X.XX ‰

Disinfection)

Disinfection)Disinfection)

Blood Leak

Blood LeakBlood Leak

Ultrafiltration

UltrafiltrationUltrafiltration

UFP: XX rpm UFP_S: XX rpm PDA: XXX mmHg PDA_S: XXX mmHg TMP: XXX mmHg

BIC Cartridge Holder

BIC Cartridge HolderBIC Cartridge Holder

BKUS: OPEN/CLOSED BKUS_S: OPEN/CLOSED VVB: OPEN/CLOSED VBICP: OPEN/CLOSED VBKO: OPEN/CLOSED VBKS: OPEN/CLOSED

Valves Online

Valves OnlineValves Online

VBE: OPEN/CLOSED VBE_S: OPEN/CLOSED VDFF: OPEN/CLOSED VDFF_S: OPEN/CLOSED VSB: OPEN/CLOSED VSB_S: OPEN/CLOSED VSAA: OPEN/CLOSED VSAA_S: OPEN/CLOSED VSAE: OPEN/CLOSED VSAE_S: OPEN/CLOSED

Pump Online

Pump OnlinePump Online

OPS: XXXX rpm OPS_S: XXXX rpm

Subst. Flow (Online)

Subst. Flow (Online)Subst. Flow (Online)

FMS: XXX ml/min FMS_S: XXX ml/min

Status Self

Blood Side (Pressure)

Blood Side (Pressure)Blood Side (Pressure)

PA: XXX mmHg PA_S: XXX mmHg PBE: XXX mmHg PV: XXX mmHg PV_S: XXX mmHg PBS: XXX mmHg PBS_S: XXX mmHg

Blood Pumps

Blood PumpsBlood Pumps

BPA: XXXX rpm BPA_S: XXXX rpm BPV: XXXX rpm BPV_S: XXXX rpm

Tubing Clamps

Tubing ClampsTubing Clamps

SAKA: OPEN/CLOSED SAKV: OPEN/CLOSED SAKV_S: OPEN/CLOSED

Air Detector

Air DetectorAir Detector

SAD: NO AIR/AIR SAD_S: NO AIR/AIR SAD TIME_S: OK SAD REF_S: XXXX mV SAD VOL: XXXX µl SAD VOL_S: XXXX µl

Heparin

HeparinHeparin

HP: STOP POSITION: XX.XX mm

Status Self Test

Status Self TestStatus Self Test

LLC: XXXXX LLS: XXXXX

LLC/S & TLC Alarm Window LLC Message Window

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 7

3.2.1 Set-Up Low Level Controller

LLC Test Codes

Format of LLC Test Co des:

LLC Test Codes Before the

Test Codes of the Individual Tests

TTSSx:

Examples

11102 33701

37991

Individual Tests

TT 00 x TT 01 x TT 02 x TT 03 x

TT 04 x TT 05 x

LLC test code to LLS Performed test step

Number of performed repeats 0 ≤ x < repeats until error message

Third blood leak detector test: send signal to blood leak detector task Second BS pressure test terminated, because during autopriming, e.g. an LF error occurred. VD test passed after the second time.

Start test. Error: timeout (10 s) at "Before Test Start Wait for Test Code 0 from LLS". Test check prerequisites (if present, see respective tests). Error: Check timeout test prerequisites (if present, timeout time see respective

tests). Wait for LLS test code from LLS.

Error: timeout (10 s) at "Before Test Start Wait for LLS Test Code from LLS".

Range 10x .... 99x

Not all test codes are displayed sequentially, due to the implementation. A higher test code always includes all the finalised subcodes with lower priority. In case of an error: The subcode always includes the subpha se where the error occurred.

3.2.2 Set-Up Low Level Supervisor LLS

Test Codes

Format of LLS Test Co des: (Value ≥ 10000)

TTSSS

SSS

Example:

11104

The test code is displayed as a numer ical value ≥ 10000. If the value is < 9000, this is the required rinsing volume for the HDFO filter rinsing in ml. If the value is > 9000 and < 10000, the last three digits displ a y the r e qui r ed HDFO filter rinsing volume in ml through the valves VSAA and VSAE ( V S B is closed).

LLS test code to LLC Performed test step

Blood leak detector test: measure level for red and green

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 8

3.2.3 Example LLC/LLS Test Codes

for Blood Leak Detector

LLC Test Code:

11 (TT):

10 (SS):

11102 11004

2 (x):

LLS Test Code:

11 (TT):

004 (SS):

LLC Test

Code

1102x

1110x

1120x Wait for D24O F F (timeout 30 s) 11011

1130x Wait for D24O N (timeout 30 s)

1199x Completed

Prerequisites for Test:

Upline tank must be filled Timeout 2 min

Test code = 11 to LLS Test code = 11 back to LLC

EV_TESTE_BLUTLECK_EIN to BlutleckTaskID Test initialisation (VGD ON)

LLC Test Steps LLS Test Steps LLS Test

Blood leak detector test Send signal to blood leak task Third repetition (x = 0, 1, 2)

Blood leak detector test Measure level for red and green

Single measurement of green, Single measurement of red, then comparison of: red ≥ green + 0.2 V no timeout Acknowledge with switch-off of VGD 11005 –

VGD ON 11012

Code

11000 – 11003

11004

3.2.4 Overview Test Codes

00 11 12 15 16 17 20 21 22 25 26 27 28 30 31 32 33 37 40

No tests Blood leak detector DFS pressure test Integrity test HDF online (only for Dialog+ HDF online) Alarm system Monitoring of analog voltage ± 12 V UF pump End conductivity Temperature TSD SMPS-MC EEPROM SMPS-MC service mode SMPS-MC battery SMPS-MC buzzer SAD: Level test SAD: Counter test Pressure sensors blood side: Equality test for blood side pressure sensors Pressure sensors blood side: Blood side pressure test Disinfection Valve VD Pressure test substitution line S-Online HDF online

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 9

3.3 Self Test in Preparation SW 9.xx Switch Mode

Power Supply Microcontroller SMPS-MC

3.3.1 Service Mode (DIR_ON)

Configuration

Test Code

Repeats Until Error Message

ID Error Message

Reaction to the Test Result in Preparation

LLC Test

Code

2610x Switch-off of VGD and VGB 26001

2620x Wait for feedback of test result via BIOS (timeout 15 s)

2630x Set set point of heater to 0

2699x Completed VGD ON

Prerequisites for Test:

Test code = 26 to LLS Test code = 26 back to LLC

Wait for D24OFF and B 24OFF (Timeout 15 s) Set set point for heater to self test code #110

LLC Test Steps LLS Test Steps LLS Test

none

3.3.2 Battery

Configuration

Test Code

Repeats Until Error Message

Switch mode power supply microcontroller SMPS-MC with and without battery 26 1

1152:

Power supply service mode - no therapy

Error: X101 connec ted ( /DI R_ON = 0)

• therapy not possible

because alarms deactivated, information text

OK: X101 open (/DIR_O N = 1)

Therapy possible

•

Code

VGB ON

Switch mode power supply microcontroller SMPS-MC with and without battery 27 3

ID Error Message

Reaction to the Test Result in Preparation

LLC Test

Code

2710x Switch-off of VGD and VGB 27001

2720x Wait for feedback of test result via BIOS (timeout 15 s)

2730x Set set point of heater to 0

2799x Completed VGD ON

Prerequisites for Test:

Test code = 27 to LLS Test code = 27 back to LLC

Wait for D24OFF and B 24OFF (Timeout 15 s) Set set point for heater to self test code #112

LLC Test Steps LLS Test Steps LLS Test

none

1150:

Selftest error SMPS battery test

Error: Battery not present or not loaded

Information text and

•

therapy possible

OK: Battery present and loaded

Therapy possible

•

VGB ON

Code

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Dialog

3.3.3 EEPROM

SW 9.xx

3. Repair Instructions 1/2010 3 - 10

Configuration

Test Code

Repeats Until Error Message

ID Error Message

Reaction to the Test Result in Preparation

LLC Test

Code

2510x Switch-off of VGD and VGB 25001

2520x Wait for feedback of test result via BIOS (timeout 15 s)

2530x Set set point of heater to 0

2599x Completed VGD ON

Prerequisites for Test:

Test code = 25 to LLS Test code = 25 back to LLC

Wait for D24OFF and B 24OFF (Timeout 15 s) Set set point for heater to self test code #113

LLC Test Steps LLS Test Steps LLS Test

3.3.4 Buzzer Test via LLS

Configuration

Test Code

Repeats Until Error Message

Switch mode power supply microcontroller SMPS-MC with and without battery 25 1

1154:

SMPS-EEPROM defective

Test is not performed at present

Answer from SMPS-MC is OK because the EEPROM is not used at present

•

Code

VGB ON

Switch mode power supply microcontroller SMPS-MC with and without battery 28 3

ID Error Message

Reaction to the Test Result in Preparation

LLC Test

Code

2810x Switch-off of VGD and VGB 28001

2820x Wait for feedback of test result via BIOS (timeout 15 s)

2830x Set set point of heater to 0

2899x Completed VGD ON

Prerequisites for Test:

Test code = 10 to LLS Test code = 10 back to LLC

Wait for D24OFF and B 24OFF (Timeout 15 s) Set set point for heater to self test code #115

LLC Test Steps LLS Test Steps LLS Test

none

1145:

Self test error SMPS buzzer test

Error: buzzer defective

Information text and

•

OK:

Therapy possible

•

Activate buzzer after app ro x. 1 s for 250 ms 28003

VGB ON

therapy possible

Code

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Dialog

SW 9.xx

3.3.5 Alarm System

3. Repair Instructions 1/2010 3 - 11

Test Code

Repeats Until Error Message

ID Error Message

Actions after Error

LLC Test

Code Code LLC LLS Code

1610x

1620x Wait for D24O F F and B24OFF (timeout 60 s since st art

1630x Wait for D24O N and B24ON (timeout 10 s)

1630x

10. 1640x Wait for D24O F F (t i meout 60 s since start of code 200)

11.

12. 1650x Wait for D24O N (timeout 10 s)

13. 1699 Completed

Prerequisites for Test:

No alarm activation Test code = 16 to LLS Test code = 16 back to LLC

OSD LED OFF, Sound OFF

No alarm activation Timeout 60 s

of code 100)

D24ON and B24ON:

Alarm activation LLC/TLC Activation test alarm with sound and OSD LED red (ID

1002)

LLC Test Steps LLS Test Steps LLS Test

16 1 1167:

Sound + LED test failed

None (test is repeated immediately)

Code

Start condition for the test:

1. „OSD-LED OFF“ detected

2. „Sound OFF“ detected Activation of the red OSD LED Wait for feedback of the activation and switch-off of

the LED Wait for LED off

Acknowledge with switch-off of the power supply trigger, i.e. switch-off of VGD and VGB

Trigger ON 16011

Condition for the test:

1. „OSD LED red left and right ON“ detected

2. „Sound ON“ detected

Acknowledge with switch-off VGD 16022 –

VGD ON 16028

16001

16002 16003

16004 16005 –

16010

16021

16027

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Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 12

3.3.6 Monitoring of Analog Voltage ±12 V

LLC Test

Code

1710x

1720x

1730x

1740x

10.

1799 Completed

11.

Objective

Test Code

Repeats Until Error Message

ID Error Message

Actions after Error

LLC Test Steps LLS Test Steps LLS Test

Prerequisites for Test:

± 12V voltage in limit range Test code = 17 to LLS Test code = 17 back to LLC

Failure of voltage check

Timeout 15 s

Voltage check OK

Timeout 15 s

Failure of voltage check

Timeout 15 s

Voltage check OK

Timeout 15 s

Check the monitoring of the analog voltage ±12 V. 17 1

1155:

12 V not passed

None (test is repeated immediately)

No test activation 17001 –

Delete test activation for voltage 1: TEST1 set

Test activation for voltage 2: TEST2n set

Delete test activation for voltage 2: TEST2n set

low

high

Code

17003

17011 – 17013

17021 – 17023

17031

3.3.7 Blood Leak Detector

Objective

Test Code

Repeats Until Error Message

ID Error Message

Actions after Error

LLC Test

Code

1. 1102x

2. Test code = 11 to LLS Test code = 11 back to LLC

3. 1110x EV_TESTE_BLUTLECK_EIN to Bl ut l eckTaskID Test initial i sat i o n (V GD ON)

4. Acknowl e dge with switch-off o f V GD 11005 –

5. 1120x Wait for D24OFF (timeo ut 30 s) 11011

6. VGD ON 11012

7. 1130x Wait for D24ON (timeo ut 30 s)

8. 1199x Completed

Prerequisites for Test:

Upline tank must be filled Timeout 2 min

LLC Test Steps LLS Test Steps LLS Test

The switch function between the LEDs and the PWM drive of the LEDs is tested. 11 3 1156:

Blood leak test not OK

Rinse, repeat all tests

11000 – Single measurement of green, Single measurement of red, then comparison of: red ≥ green + 0.2 V no timeout

11003

11004

Code

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Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 13

3.3.8 DFS Pressure Test (Table)

Objective

Test Code

Repeats until error message

ID Error Message

Actions after error

LLC Test

Code

1. Prerequisites for Test:

Upline tank must be filled

1220x

1221x

1230x

1235x

1240x

Test code = 12 to LLS Test code = 12 back to LLC

Membrane Movement VDABK

FPE = 1500 ml⋅/min FPA = 20 ml/min

Valve Status:

VEBK1/2, VDEBK1/2, VABK1/2 --------- opened VDABK1/2 ----------------------------- closed VBP, VDA, VDE------------------------ opened VLA ---------------------- (5 s to vent) opened

Final Condition:

No further drop of the values for the balance chamber sensors or timeout 60 s

Pressure build-up VDABK

FPE = 1500 ml⋅/min FPA = 20 ml/min

Valve Status:

VEBK1/2, VDEBK1/2, VABK1/2 ------------opened VDABK1/2------------------------------ closed VDE, VDA, VBP------------------------ opened

Final Condition:

PDA ≥ +425 mmHg for 1 s or timeout 60 s

Pressure reduction UFP

FPE = 500 ml/min FPA = 100 ml/min

Valve Status:

VEBK1/2, VABK1/2 -----------------------opened VDA B K1 / 2 , V D E B K 1/ 2 ------------------- closed VDE, VBP ----------------------------- opened VDA----------------------------------- closed PDA ≤ +380 mmHg or timeout 60 s

VBP test

FPE = 800 ml/min FPA = 100 ml⋅/min

Valve Status:

VEBK1/2, VABK1/2, VDEBK1/2 ------------opened VDABK1/2------------------------------ closed VDE, VBP ------------------------------ closed VDA---------------------------------- opened Test timeout 30 s or wait for inversio n of LLS_SELFTESTBIT from LLS

VDE/VDA test

FPE = 800 ml/min FPA = 100 ml/min

Valve Status:

VEBK1/2, VDEBK1/2, VABK1/2 --------- opened VDABK1/2 ----------------------------- closed VBP ---------------------------------- opened VDA, VDE------------------------------ closed Test timeout 60 s or wait for inversio n of LLS_SELFTESTBIT from LLS

LLC Test Steps LLS Test Steps LLS Test

Pressure test of the balance system and function test of the valves, drive of UFP for function test of speed detection. 12 1 1157:

DF pressure test will be repeated

Rinse, repeat all tests.

Code

Wait until VLA is detected as opened 12000

12019

Wait until VLA is detected as closed 12020

12021

Start condition for the test (2,5 s):

1. Correct valve position

2. UFP stopped (UF rate < 500 ml/h)

3. 300 mmHg < PDA < +450 mmHg Test 5 s,

max. deviation ∆PDA < 25 mmHg, Acknowledge with inversion of LLS_SELFTESTBIT

Start condition for the test (2,5 s):

1. Correct valve position

2. UFP stopped (UF rate < 500 ml/h)

3. 300 mmHg < PDA < +450 mmHg Test 5 s,

max. deviation ∆PDA < 25 mmHg, Acknowledge with inversion of LLS_SELFTESTBIT

12021 – 12026

12027 – 12036 12037

12038

12061 – 12066

12067 – 12076 12077

12078

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B. Braun Avitum AG

Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 14

10.

11.

1245x

1250x

1255x

1260x

1265x

1270x

VDABK

Pressure build-up

FPE = 500 ml/min FPA = 100 ml/min

Valve Status:

VEBK1/2, VDEBK1/2, VABK1/2 --------- opened VDABK1/2 ----------------------------- closed VBP, VDA, VDE------------------------ opened PDA ≥ +425

Pressure reduction with UFP

FPE = 800 ml/min FPA = 20 ml/min

Valve Status:

VEBK1/2, VDABK1/2------------------- opened VDEBK1/2, VABK1/2-------------------- closed VBP, VDE ----------------------------- opened VDA----------------------------------- closed PDA ≤ +380 mmHg or timeout 60 s

Membrane test

FPE = 800 ml/min FPA = 20 ml/min

Valve Status:

VEBK1/2, VDABK1/2------------------- opened VDEBK1/2, VABK1/2-------------------- closed VBP, VDE, VDA------------------------ opened Test timeout 60 s or wait for inversio n of LLS_SELFTESTBIT from LLS

Pressure build-up VABK

FPE = 500 ml/min FPA = 500 ml/min

Valve Status:

VEBK1/2, VDEBK1/2, VDABK1/2-------- opened VABK1/2 ------------------------------ closed VBP, VDA, VDE------------------------ opened PDA ≥ +425 mmHg for 1 s or timeout 60 s

Membrane movement

FPE = 500 ml/min FPA = 1500 ml⋅/min

Valve Status:

VEBK1/2, VABK1/2 --------------------- closed VDEBK1/2, VDABK1/2 ----------------- opened VBP, VDA, VDE------------------------ opened Test timeout 60 s or no increase of the values of the membrane position sensors

Pressure reduction with UFP

FPE = 500 ml/min FPA = 500 ml/min

Valve Status:

VEBK1/2, VABK1/2 --------------------- closed VDEBK1/2, VDABK1/2 ----------------- opened VBP, VDE ----------------------------- opened VDA----------------------------------- closed PDA ≤ +380 mmHg or timeout 60 s

VDABK

VDABKVDABK

for 1 s or timeout 60 s

mmHg

Start condition for the test (10 s):

1. Correct valve position

2. UFP stopped (UF rate < 500 ml/h)

3. +300 mmHg < PDA < +450 mmHg Test 10 s,

max. deviation ∆PDA < 25 mmHg, Acknowledge with inversion of LLS_SELFTESTBIT

12101

12101 – 12121

12122 – 12131 12132

12133 12151

12151

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Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 15

1275x

12.

1280x

13.

1299 Completed

14.

VEBK test

FPE = 800 ml/min FPA = 500 ml/min

Valve Status:

VEBK1/2, VABK1/2 --------------------- closed VDEBK1/2, VDABK1/2 ----------------- opened VBP, VDE, VDA------------------------ opened Test timeout 60 s or wait for inversio n of LLS_SELFTESTBIT from LLS

Pressure reduction

FPE = 500 ml/min FPA = 500 ml/min

Valve Status:

VEBK1/2, VDEBK1/2------------------- opened VABK1/2, VDABK1/2------------------- opened VBP, VDA, VDE------------------------ opened

Timeout 60 s

Start condition for the test (5 s):

1. Correct valve position

2. UFP stopped (UF rate < 500 ml/h)

3. +300 mmHg < PDA < +450 mmHg Test 10 s,

max. deviation ∆PDA < 25 mmHg, Acknowledge with inversion of LLS_SELFTESTBIT

12151 – 12161

12162 – 12181 12182

12183 12000

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Dialog

3.3.8.1 DFS Pressure Test

SW 9.xx

3. Repair Instructions 1/2010 3 - 16

General Comments

The closing function of VLA is tested implicitly together with all tests that generate an overpressure at PDA, because the overpressure is not built up and not maintained when VLA is open. Therefore an explicit test of VLA is not required. DFS pressure test:

A controlled membrane movement is performed to the outlet

•

side prior to the phase The FPE and FPA pumps are set to 1500 ml/min in phases with

•

membrane movement. Thus a fast movement of the membrane is achieved.

UFP is activated during the pressure build-up phase and thus

•

tested. The evaluation of the pressure changes in a test interval is

•

performed via the pressure at the end of the test interval. (The pressure difference to the minimum and maximum sensor value is created in the test interval.)

VLA is opened for 5 s at the beginning of the test to ensure

•

that the air separator is completely filled with water. Simultaneously the function for the monitoring of the current is checked.

Pressure build-up VDABK

UFP is started during the pressure build-up phase.

•

The acknowledgement of the single test steps in the DFS

•

pressure test is performed via a bit in the internal communication (between LLS and LLC).

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Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 17

3.3.8.2 Membrane Movement/Pressure Build-up VDABK

VDE

VBP

VDEBK

FPE

VEBK

RVDA

Fig. : Flow Diagram Membrane Movement/Pressure Build-up VDABK

The speed for FPE and FPA are slowly set in increments of 200 min-1 to a maximum flow of 1500 ml/min and 10 ml/min respectively. The membrane movement with the resultin g pressure build-up is terminated after no further drop of the values for the balance chamber sensors is detected. The membrane is moved to the outlet.

LLC Test

Code

1220x

1221x

Membrane movement VDABK

FPE = 1500 ml/min FPA = 20 ml/min

Valve Status:

VEBK1/2, VDEBK1/2, VABK1/2 ------------opened VDABK1/2------------------------------ closed VDE, VDA, VBP------------------------ opened VLA ---------------------- open to vent for 5 s

Final Condition:

No further drop of the values for the balance chamber sensors or timeout 60 s

Pressure build-up VDABK

FPE = 1500 ml⋅/min FPA = 20 ml/min

Valve Status:

VEBK1/2, VDEBK1/2, VABK1/2 ------------opened VDABK1/2------------------------------ closed VDE, VDA, VBP------------------------ opened

Final Condition:

PDA ≥ +425 mmHg for 1 s or timeout 60 s

LLC Test Steps LLS Test Steps LLS Test

VDABK

VABK

FPA

Wait until VLA is detected as opened 12000

Wait until VLA is detected as closed 12020

VDA

UFP

PDA

open

offen

closed

geschlossen

Code

12019

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Dialog

3.3.8.3 Pressure Reduction VDABK

SW 9.xx

with UFP

3. Repair Instructions 1/2010 3 - 18

VDE

VBP

VDEBK

FPE

VEBK

RVDA

Fig. : Flow Diagram Pressure Reduction VDABK with UFP

LLC Test

Code

1230x

Pressure reduction UFP

FPE = 500 ml/min FPA = 100 ml/min

Valve Status:

VEBK1/2, VABK1/2 -----------------------opened VDA B K1 / 2 , V D E B K 1/ 2 ------------------- closed VDE, VBP ----------------------------- opened VDA----------------------------------- closed

Final Condition:

PDA ≤ +380 mmHg or timeout 60 s

LLC Test Steps LLS Test Steps LLS Test

VDABK

FPA

VABK

The pressure at PDA is reduced built-up to ≤ 380 mmHg with the UF pump after the dialyser test circuit is closed. The UF pump is driven with 3000 ml/h. VDA is closed during this pressure reduction. Thus the UF pump strokes are damped via the extended flow path and no interferences are generated at PDA.

VDA

UFP

PDA

open

offen

closed

geschlossen

Code

12021

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Dialog

SW 9.xx

3.3.8.4 VBP Test

3. Repair Instructions 1/2010 3 - 19

VDE

VBP

FPE

RVDA

Fig. : Flow Diagram VBP Test

LLC Test

Code

1235x

VBP test

FPE = 800 ml/min FPA = 100 ml/min

Valve Status:

VEBK1/2, VABK1/2, VDEBK1/2 ------------opened VDABK1/2------------------------------ closed VDE, VBP ------------------------------ closed VDA---------------------------------- opened

Final Condition:

Test timeout 30 s or wait for inversio n of LLS_SELFTESTBIT from LLS

VDEBK

VEBK

A pressure drop indicates a leakage at any component, e.g. rinse bridge, dialyser, UF pump, o-ring etc..

Test VDE/VBP

Test VDABK

Timeout

LLC Test Steps LLS Test Steps LLS Test

A leakage of the valves leads to a pressure increase at PDA. A leakage of the valve leads to a pressure increase at PDA. 30 s

VDABK

VABK

FPA

Start condition for the test (2.5 s):

1. Correct valve position

2. UFP stopped (UF rate < 500 ml/h)

3. 300 mmHg < PDA < +450 mmHg Test 5 s,

max. deviation ∆PDA < 25 mmHg,

Acknowledge with inversion of LLS_SELFTESTBIT

VDA

UFP

PDA

open

offen

closed

geschlossen

Code

12021 – 12026

12027 – 12036 12037

12038

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Dialog

SW 9.xx

3.3.8.5 VDE/VDA Test

3. Repair Instructions 1/2010 3 - 20

VDE

VBP

FPE

RVDA

Fig. : Flow Diagram VDE/VDA Test

LLC Test

Code

1240x

VDE/VDA test

FPE = 800 ml/min FPA = 100 ml/min

Valve Status:

VEBK1/2, VDEBK1/2, VABK1/2 --------- opened VDABK1/2 ----------------------------- closed VBP ---------------------------------- opened VDA, VDE------------------------------ closed

Final Condition:

Test timeout 60 s or wait for inversio n of LLS_SELFTESTBIT from LLS

VDEBK

VEBK

Test VDE/VDA

LLC Test Steps LLS Test Steps LLS Test

A leakage of the valves leads to a pressure increase at PDA.

VDABK

VABK

FPA

Start condition for the test (2.5 s):

1. Correct valve position

2. UFP stopped (UF rate < 500 ml/h)

3. 300 mmHg < PDA < +450 mmHg Test 5 s,

max. deviation ∆PDA < 25 mmHg,

Acknowledge with inversion of LLS_SELFTESTBIT

VDA

UFP

PDA

open

offen

closed

geschlossen

Code

12061 – 12066

12067 – 12076 12077

12078

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Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 21

3.3.8.6 Pressure Build-up VDABK

VDE

VBP

VDEBK

FPE

VEBK

RVDA

Fig. : Flow Diagram Pressure Build-up VDABK

LLC Test

Code

1245x

Pressure build-up VDABK

FPE = 500 ml/min FPA = 100 ml/min

Valve Status:

VEBK1/2, VDEBK1/2, VABK1/2 --------- opened VDABK1/2 ----------------------------- closed VBP, VDA, VDE------------------------ opened

Final Condition:

PDA ≥ +425 mmHg for 1 s or timeout 60 s

LLC Test Steps LLS Test Steps LLS Test

VDABK

FPA

VABK

If PDA < 425 mmHg: The speed for FPE and FPA is slowly set in increments of 200 min respectively. The pressure build-up is completed if PDA is ≥ 425 mmHg for more than 1 s.

-1

in 250 ms to a maximum flow of 500 ml/min and 100 ml/min

VDA

UFP

PDA

open

offen

closed

geschlossen

Code

12101

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Dialog

3.3.8.7 Pressure Reduction Membrane

SW 9.xx

Test with UFP

3. Repair Instructions 1/2010 3 - 22

VDE

VBP

VDEBK

FPE

VEBK

RVDA

Fig. : Flow Diagram Pressure Reduction Membrane Test with UFP

The pressure at PDA is decreased to ≤ 380 mmHg with the UF pump after the dialyser test circuit is closed. The UF pump is driven with 3000 ml/h. VDA is closed during this pressure reduction. Thus the UF pump strokes are damped via the extended flow path and no interferences are generated at PDA. During this pressure reduction t he speeds for the following test are set to: FPE for a flow of 800 ml/min and FPA for 20 ml/min. Thus the membrane is pressed to the outlet side. Timeout: 60 s

LLC Test

Code

1250x

Pressure reduction with UFP

FPE = 800 ml/min FPA = 20 ml/min

Valve Status:

VEBK1/2, VDABK1/2------------------- opened VDEBK1/2, VABK1/2-------------------- closed VBP, VDE ----------------------------- opened VDA----------------------------------- closed

Final Condition:

PDA ≤ +380 mmHg or timeout 60 s

LLC Test Steps LLS Test Steps LLS Test

VDABK

VABK

FPA

VDA

UFP

PDA

open

offen

closed

geschlossen

Code

12101

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Dialog

SW 9.xx

3.3.8.8 Membrane Test

3. Repair Instructions 1/2010 3 - 23

VDE

VBP

FPE

RVDA

Fig. : Flow Diagram Membrane Test

Test Membrane

LLC Test

Code

1255x

Membrane test

FPE = 800 ml/min FPA = 20 ml/min

Valve Status:

VEBK1/2, VDABK1/2------------------- opened VDEBK1/2, VABK1/2-------------------- closed VBP, VDE, VDA------------------------ opened

Final Condition:

Test timeout 60 s or wait for inversio n of LLS_SELFTESTBIT from LLS

VDEBK

VEBK

The membrane is loaded with a pressure of 1.3 bar due to the high speed of FPE with a flow of 800 ml/min. A leakage would cause a pressure increase at PDA. FPA runs with a slow speed during this test to prevent a back pressure.

Test VDEBK

LLC Test Steps LLS Test Steps LLS Test

A leakage of the valve leads to a pressure increase at PDA.

VDABK

VABK

FPA

Start condition for the test (10 s):

1. Correct valve position

2. UFP stopped (UF rate < 500 ml/h)

3. +300 mmHg < PDA < +450 mmHg Test 10 s,

max. deviation ∆PDA < 25 mmHg, Acknowledge with inversion of LLS_SELFTESTBIT

VDA

UFP

PDA

open

offen

closed

geschlossen

Code

12101 – 12121

12122 – 12131 12132 12133

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Dialog

3.3.8.9 Pressure Build-up VABK

SW 9.xx

3. Repair Instructions 1/2010 3 - 24

VDE

VBP

VDEBK

FPE

VEBK

RVDA

Fig. : Flow Diagram Pressure Build-up VABK

LLC Test

Code

1260x

Pressure build-up VABK

FPE = 500 ml/min FPA = 500 ml/min

Valve Status:

VEBK1/2, VDEBK1/2, VDABK1/2-------- opened VABK1/2 ------------------------------ closed VBP, VDA, VDE------------------------ opened

Final Condition:

PDA ≥ +425 mmHg for 1 s or timeout 60 s

LLC Test Steps LLS Test Steps LLS Test

VDABK

FPA

VABK

If PDA < 425 mmHg: the speed for FPE and FPA is slowly set in increments of 200 min The pressure build-up is completed if PDA is ≥ 425 mmHg for more than 1 s.

-1

to a maximum flow of 500 ml/mi n and 100 ml/min respectively .

VDA

UFP

PDA

open

offen

closed

geschlossen

Code

12151

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Side

SW 9.xx

Dialog

3.3.8.10 Membrane Movement to Inlet

3. Repair Instructions 1/2010 3 - 25

VDE

VBP

VDEBK

FPE

VEBK

RVDA

Fig. : Flow Diagram Membrane Movement to Inlet Side

10.

LLC Test

Code

1265x

Membrane movement

FPE = 500 ml/min FPA = 1500 ml/min

Valve Status:

VEBK1/2, VABK1/2 --------------------- closed VDEBK1/2, VDABK1/2 ----------------- opened VBP, VDA, VDE------------------------ opened

Final Condition:

Test timeout 60 s or no increase of the values of the membrane position sensors

LLC Test Steps LLS Test Steps LLS Test

VDABK

FPA

VABK

The FPA pump is driven with 1500 ml/min and moves the membrane to the inlet side. Thus an overpressure is built up at the valves VABK1/2 for the next test step. If the membrane is not in end position: Only the pressure of the throttle DDE is built-up prior to the valves, due to the volume shift.

VDA

UFP

PDA

open

offen

closed

geschlossen

Code

12151

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UFP

SW 9.xx

Dialog

3.3.8.11 Pressure Reduction VABK with

3. Repair Instructions 1/2010 3 - 26

VDE

VBP

VDEBK

FPE

VEBK

RVDA

Fig. : Flow Diagram Pressure Reduction VABK with UFP

11.

LLC Test

Code

1270x

Pressure reduction with UFP

FPE = 500 ml/min FPA = 500 ml/min

Valve Status:

Final Condition:

PDA ≤ +380 mmHg or timeout 60 s

LLC Test Steps LLS Test Steps LLS Test

VDABK

FPA

VABK

The pressure at PDA is reduced to ≤ 380 mmHg with the UF pump. The UF pump is driven with 3000 ml/h. VDA is closed during this pressure reduction. Thus the UF pump strokes are damped via the extended flow path and no interferences are generated at PDA. The valve VZ is opened so that the high pre-pressure at RVDA can be reduced to the outlet side and that a su fficient pressure gradient is present at VABK and UFP for the next test.

VDA

UFP

PDA

open

offen

closed

geschlossen

Code

12151

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3.3.8.12 VEBK Test

SW 9.xx

3. Repair Instructions 1/2010 3 - 27

VDE

VBP

FPE

RVDA

Fig. : Flow Diagram VEBK Test

LLC Test

Code

1275x

12.

VEBK test

FPE = 800 ml/min FPA = 500 ml/min

Valve Status:

VEBK1/2, VABK1/2 --------------------- closed VDEBK1/2, VDABK1/2 ----------------- opened VBP, VDE, VDA------------------------ opened

Final Condition:

Test timeout 60 s or wait for inversio n of LLS_SELFTESTBIT from LLS

VDEBK

VEBK

Test VEBK1/2

Test VABK1/2

LLC Test Steps LLS Test Steps LLS Test

VDABK

FPA

VDA

PDA

open

VABK

UFP

offen

closed

geschlossen

VEBK is charged by the maximum delivery pressure from FPE (set at RVFPE). A leakage of the valves leads to a pressure increase at PDA.

VABK is charged by the maximum delivery pressure from FPA (set at RVFPA). A leakage of the valves leads to a pressure increase at PDA.

Code

Start condition for the test (5 s):

1. Correct valve position

2. UFP stopped (UF rate < 500 ml/h)

3. +300 mmHg < PDA < +450 mmHg Test 10 s,

max. deviation ∆PDA < 25 mmHg,

Acknowledge with inversion of LLS_SELFTESTBIT

12151 – 12161

12162 – 12181 12182

12183

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3.3.8.13 Pressure Reduction

SW 9.xx

3. Repair Instructions 1/2010 3 - 28

VDE

VBP

VDEBK

FPE

VEBK

RVDA

Fig. : Flow Diagram Pressure Reduction

LLC Test

Code

1280x

13.

VEBK test

FPE = 500 ml/min FPA = 500 ml/min

Valve Status:

VEBK1/2, VDEBK1/2------------------- opened VABK1/2, VDABK1/2------------------- opened VBP, VDA, VDE------------------------ opened

VDABK

FPA

VABK

A pressure level is set at PDA between –200 mmHg and +200 mmHg by opening all valves and driving the pumps accordingly.

LLC Test Steps LLS Test Steps LLS Test

VDA

UFP

PDA

open

offen

closed

geschlossen

Code

12000

Timeout 60 s

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3. Repair Instructions 1/2010 3 - 29

3.3.9 Integrity Test HDF Online

Simultaneous pressure build-up of DF

filter and HDF filter

Objective

Test code

Repeats until error message

ID error message

Actions after error

LLC Test

Code

1502x

Prerequisites for Test:

Upline tank must be filled, PSAUS, PSABF and BPV cover must be closed. Timeout 2 min

1510x

Test code = 15 to LLS Test code = 15 back to LLC

Pressure Reduction for VBE Test with FPA:

Pressure reduction with FPA unti l P DA < -300 mmHg

Valve Status:

VDEBK1/2, VEBK1/2-------------------- closed VDABK1/2, VABK1/2------------------- opened VBE, VDFF, VDE, VSB-------------------- closed VBP, VDA, VSAE, VSAA----------------- opened Timeout 1 min

1515x

VBE Pressure Test Valve Status:

VDEBK1/2, VEBK1/2-------------------- closed VDABK1/2, VABK1/2-------------------- closed VBE, VDFF, VDE, VSB-------------------- closed VBP, VDA, VSAE, VSAA----------------- opened

Test timeout 1 min or wait for switch-off V G D from LLS

1520x

Pressure Reduction for VSAE Test with UFP:

Pressure reduction with UFP until PDA < -300 mmHg

Valve Status:

VDEBK1/2, VEBK1/2------------------- opened VDABK1/2, VABK1/2-------------------- closed VBE, VDFF, VDE, VSB, VBP, VSAE--------- closed VDA, VSAA---------------------------- opened Timeout 1 min

1525x

VSAE Pressure Test and OSP Test

FPE = 1000 ml/min

Valve Status:

VDEBK1/2, VEBK1/2------------------- opened VDABK1/2, VABK1/2-------------------- closed VBE, VDFF, VDE, VSB, VBP, VSAE--------- closed VDA, VSAA---------------------------- opened

Test timeout 1 min or wait for switch-off V G D from LLS

LLC Test Steps LLS Test Steps LLS Test

Detection of safety relevant ruptures, pressure test of the su bstitution system in the machine, pressure test of VBE/VSAE/VSAA. Air can not pass the semipermeable filter membrane at n egative pressure of > -500 mmHg. To detect ruptures: One side of the filter is f illed with air; On the other side a negative pressure < -270 mmHg is built up. If the pressure drop is < 20 mmHg in 3 min, safety relevant ruptures are not present. The final openin g of VBP must be detected by LLS via PDA. Thus it is guaranteed that the filters were filled with air and VBE was opened. 15 1 1151:

HDF online filter test failed!

Rinse, repeat all tests

Code

Start condition for the test (5 s):

4. Correct valve position

15001 – 15010

5. UFP stopped (UF rate < 500 ml/h)

6. -450 mmHg < PDA < -150 mmHg Test 10 s,

15011

max. deviation ∆PDA < 50 mmHg, PDA < -100 mmHg Acknowledge with switch-off of VGD

15012 – 15018

Start condition for the test (5 s):

1. Correct valve position

15021 – 15030

2. UFP stopped (UF rate < 500 ml/h)

3. PDA < -150 mmHg Test 10 s,

max. deviation ∆PDA < 50 mmHg, PDA < -100 mmHg

Test delivery rate OSP at 200 ±15 ml/min Acknowledge with switch-off of VGD

15031, 15032

15033 15034 – 15039

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1530x

1535x

1540x

1545x

10.

1550x Wait 1 s

11.

1555x

12.

1560x

13.

SW 9.xx

Pressure Reduction for VSAA Test with UFP:

Pressure reduction with UF P until P DA < –300 mmHg

Valve Status:

VDEBK1/2, VEBK1/2------------------- opened VDABK1/2, VABK1/2-------------------- closed VBE, VDFF, VDE, VSB, VBP, VSAA -------- closed VDA, VSAE---------------------------- opened Timeout 1 min

VSAA Pressure Test

FPE = 1000 ml/min

Valve Status:

VDEBK1/2, VEBK1/2------------------- opened VDABK1/2, VABK1/2-------------------- closed VBE, VDFF, VDE, VSB, VBP, VSAA -------- closed VDA, VSAE---------------------------- opened

Test timeout 1 min or wait for switch-off V G D from LLS

Pressure Equalisation for 60 s Valve Status:

VDEBK1/2, VEBK1/2------------------- opened VDABK1/2, VABK1/2-------------------- closed VBE, VDE ------------------------------ closed VDFF, VBP, VSB, VDA, VSAE, VSAA------ opened

Filter Pressure Reduction with FPA:

Pressure reduction with FPA until PDA < –300 mmHg more than 4 s Opened VBE at PDA < –150 mmHg mor e than 2 s Close VBE at PDA > –150 mmHg

Valve Status:

VDEBK1/2 ----------------------------- closed VDABK1/2, VABK1/2------------------- opened VDE, VBP, VSAA------------------------ closed VDFF, VSB, VDA ----------------------- opened Timeout 3 min

Filter Pressure Reduction with UFP:

Control negative pressure with UFP (–320 mmHg) PDA < -150 mmHg: VBE opened PDA > -10 mmHg: VBE closed

Valve Status:

VDEBK1/2 ----------------------------- closed VDABK1/2 ----------------------------- closed VDE, VBP, VSAA------------------------ closed VDFF, VSB, VDA ----------------------- opened Timeout 3 min

Filter Pressure Test Valve Status:

VDEBK1/2 ----------------------------- closed VDABK1/2 ----------------------------- closed VDE, VBP, VSAA------------------------ closed VDFF, VSB, VDA, VBE ------------------ opened

Test timeout 1 min or wait for switch-off V G D from LLS

3. Repair Instructions 1/2010 3 - 30

Start condition for the test (5 s):

1. Correct valve position

2. UFP stopped (UF rate < 500 ml/h)

3. PDA < -150 mmHg Test 10 s,

max. deviation ∆PDA < 50 mmHg, PDA < -100 mmHg Acknowledge with switch-off of VGD

Start condition for the test (5 s):

1. Correct valve position

2. UFP stopped (UF rate < 500 ml/h)

3. VBE opened

4. PDA < -250 mmHg Test 10 s,

max. deviation ∆PDA < 50 mmHg, PDA < -200 mmHg Acknowledge with switch-off of VGD

15041 – 15050

15051

15052 – 15058

15101 – 15110

15111

15112 – 15118

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SW 9.xx

3. Repair Instructions 1/2010 3 - 31

1565x Opened VBP to ac knowledge that air is re ally in

14.

the filter. Test timeout 1 min or wait for switch-off V G D from LLS

1580x (Error ) PS A U S and/or PSABF not closed

15.

1599x Completed

16.

3.3.10 UF Pump

Repeats until error message

LLC Test

Code

2002x

2010x Set timeout timer T est i niti alisation 20000 –

2020x Wait for D24O FF (timeout 10 s)

2030x Wait for D24O N ( t imeo ut 10 s)

2099x Completed

Prerequisites for Test:

Upline tank must be filled Timeout 2 min Test code = 20 to LLS Test code = 20 back to LLC

Objective

Test code

ID error message

Actions after error

LLC Test Steps LLS Test Steps LLS Test

Test Condition:

1. Correct valve position

2. VBP, VBE opened

3. UFP stopped (UF rate < 500 ml/h)

4. PDA > -100 mmHg Acknowledge with switch-off of VGD

The pressure reduction in the filters is first performed with FPA. The speed is controlled to build up a negative pressure of approx. -290 mmHg at PDA. If the pressure at PDA is < -300 mmHg the UF pump is switched on to reduce the pressure, and the balance chamber valves VDABK1/2 are closed.

Pressure reduction with FPA

PDA > -300 mmHg

Pressure reduction with UF pump

PDA > -300 mmHg UF rate = 3000 ml/h PDA > -320 mmHg UF rate = 1000 ml/h

The function of the speed detection is tested. 20 1 1158:

UF pump test will be repeated

Repeat DFS pressure test and if necessary integrity test HDF online.

Since the start of the DFS pressure test more than 3 revolutions have been detected Acknowledge with switch-of f of V G D 20006 –

VGD ON 20012

100 ml/min ≤ FPA ≤ 1000 ml/min

15120

15121 15127

Code

20004 20005

20011

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SW 9.xx

3.3.11 Conductivity

3. Repair Instructions 1/2010 3 - 32

Objective

Test code

Repeats until error message

ID error message

Actions after error

LLC Test

Code

2110x Test initiali s a t io n 21000 –

2120x Wait for D24O FF (timeout 10 s)

2130x Wait for D24O N ( t imeo ut 10 s)

2199x Completed

Test Prerequisites - None: Test code = 21 to LLS Test code = 21 back to LLC

LLC Test Steps LLS Test Steps LLS Test

The function of the END-LF sensors is tested. 21 1 1159:

Conductivity test not OK

Rinse, repeat all tests.

Evaluation of the LF value test After passing the DFS pressure test ENDLF-S must reach the following va l ue:

- ENDLF-S > ENDLF-S

- ENDLF-S ≥ 11.4 mS/cm

- ENDLF-S ≤ 17.85 mS/cm Acknowledge with switch-of f of V G D 21066 –

VGD ON 21012

ENDLF-S

DFS-Pressure Test

is stored at the beginning of the DFS pressure tests

DFS-Pressure Test

+ 5 mS/cm

Code

21004 21005

21011

3.3.12 Temperature TSD

Repeats until error message

ID error message

Actions after error

LLC Test

Code

2202x Prerequisites for Test:

If test temperature was not yet reac hed:

- Set warning 1102

- Wait for max. 3 min to r each the test temperature

Test temperature reached or wait time exceeded:

- Delete warning 1102

- Perform test.

2210x If test temperatur e (>41 °C) was not yet reached:

2220x Wait for D24O FF (timeout 10 s)

2230x Wait for D24O N ( t imeo ut 10 s)

2299x Completed

Test code = 22 to LLS Test code = 22 back to LLC

Test not passed otherwise: timeout - set timer

Objective

Test code

LLC Test Steps LLS Test Steps LLS Test

The function of the TSD sensors is tested. 22 1 1160:

Temperature test not OK

Rinse, repeat all tests.

Test initialisation 22000 – After the start of the preparation: TSD-S must

exceed 41 °C and be < 50 °C. The heater is switched off at TSD-S > 41 °C Acknowledge with switch-of f of V G D 22006 –

VGD ON 22012

Code

22004 22005

22011

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SW 9.xx

3.3.13 SAD Level Test

Repeats until error message

ID error message

Actions after error

LLC Test

Code

3002x

3010x Set wait t i mer Test initiali s at i o n 30000

3020x After 3 s signal EV_DAU ERTEST_SAD_EIN send to

3030x Wait for B24OFF (timeout 10 s)

3040x Wait for B24ON (timeout 10 s)

10.

3099x Completed

11.

Test Prerequisites:

Blood side must not be stopped by TLC or LLC. If stopped: Message 1140 is displayed. No timeout. Test code = 30 to LLS Test code = 30 back t o LLC

BIOS-SAD-Task

If B24OFF signal EV_DAU ER TEST_SAD_AUS send to BIOS-SAD-Task

3. Repair Instructions 1/2010 3 - 33

The level test measures the test threshold, which LLC generates to drive the SAD with a permanent test pulse. This is compared with the calibrated test threshold ± 50 mV. If the measured test threshold is in this limit LLS switches off the +24 V for 3 s. This is detected by LLC as "test passed".

Test code

LLC Test Steps LLS Test Steps LLS Test

30 3 1161:

SAD (Ref.) test not OK

Return to window: Repeat blood line self test with

If deviation SAD-Ref ≤ 50 mV then carry on If deviation SAD-Ref ≤ 50 mV then acknowledge with

switch-off VGB Acknowledge w i t h switch-off VGB 30003 -

VGB ON 30009

key.

Code

30001 30002

30008

3.3.14 SAD Counter Test

Repeats until error message

ID error message

Actions after error

LLC Test

Code

3102x

3110x Send signal EV_COUNTER_TEST_SAD to B IOS-SAD-

3120x Wait for B24OFF (timeout 10 s)

3130x Wait for B24ON (timeout 10 s)

3199x Completed

Prerequisites for Test:

Blood side must not be stopped by TLC or LLC. If stopped: Message 1140 is displayed. No timeout. Test code = 31 to LLS Test code = 31 back t o LLC

Task

The counter test measures the time base of the counter for the TIMECONTR signal. LLC triggers and a low pulse of 1666 µs is generated at the TIMECONTR signal, which is measured by LLS. If this puls e is in the range of 1666 µs ±30 µs LLS switches off the +24 VB for 3 s. This is detected by LLC as "test passed".

Test code

LLC Test Steps LLS Test Steps LLS Test

31 3 1162:

SAD (Freq.) test not OK

Return to window: Repeat blood line self test with

Test initialisation 31000

If measurement of TIMECONTR pulse lengt h 1629 µs t ≤ 1689 µs, then acknowled g e with switch-off VGB Acknowledge w i t h switch-off VGB 31002 –

VGB ON 31008

key.

≤

Code

31001

31007

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SW 9.xx

3. Repair Instructions 1/2010 3 - 34

3.3.15 Equality Test for Blood Side Pressure Sensors

Objective Test code

Repeats until error message

ID error message

Actions after error

LLC Test

Code

3202x

3210x LLC activates V BT, VPA, VPV, VPU and S AK A

3220x

3230x LLC deactiva tes VBT, VPA, VPV, S AK A

3240x

3250x LLC deactivat es VBE and VPU

3260x Wait for inve rsion of LLS_SELFTESTBIT from LLS

10.

11.

12.

13.

3260x (Error) receive d B24ON - mean value of PA and P V

14.

15.

16.

Prerequisites for Test:

Blood side must not be stopped by TLC or LLC.

If stopped: Message 1140 is displayed. No timeout.

If BS is not stopped HDFonline task mu st enable

the start of the tests. A delay occurs only with autopriming (set pressure). Timeout 2 min

Test code = 32 to LLS Test code = 32 back t o LLC

VPU must be activated to prevent a pressure equalisation to the environment and that the levels in the chambers do not change. VPE remains closed to prevent a pressure equalisation if PBE is not connected.

Test timeout 60 s and wait for inversion of LLS_SELFTESTBIT from LLS

and activates VPE

Test timeout 60 s and wait for inversion of LLS_SELFTESTBIT from LLS

VPD is activated PPR is activated with the PWM PPRLOW (PWM for line with small chamber, setting in TSM) Initialise mean value storage for PA, PV, PBS and PBE Check of current detection for VBT, VPA, VPV, VPE, VPD

(timeout 15 s) Evaluate every 250 ms conti nuo us mean value from the 4 values of PA, PV, PBS and PBE.

Detected inversion of LLS_SELFTESTBIT Calculate mean value storage of PA, PV, PBS and PBE

deviate more than ±40 mmHg. (Error) the test prerequisites from HDFonl ine -Task are not given during one of the test steps (e.g. autopriming, HDF filter rinsing required after LF error). Completed Close VPD

LLC Test Steps LLS Test Steps LLS Test

The pressure sensors are connected together via the filled tu bing system with bag and thus have the same pressure level. Additionally the feedback of the level regulation valves, the level regulation pump LRP (PPR) and the SAKA are checked. Test the equality of pressure sensors with opened tubing system. 32 3 1163:

Blood side pressure sensor test not OK

Return to window: Repeat blood line self test with

Test initialisation 32000

Check of current detection for VBT, VPA, VPV, VPE, VPD, SAKA and PPR

Acknowledge with inversion of LLS_SELFTESTBIT

Check of current detection for VBT, VPA, VPV, VPE, VPD, SAKA and PPR

Acknowledge with inversion of LLS_SELFTESTBIT

and PPR Save values from PA, PV, PBS, PBE and compare the pressure sensor PA, PV, PBE and PBS (if present):

key.

Code

32001

32020

32002 32004

32005

32006

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3. Repair Instructions 1/2010 3 - 35

3.3.16 Pressure Test Substitution Line

S-Online HDF Online

Test code

Repeats until error message

ID error message

Actions after error

LLC Test

Code

4002x

4010x Opened V S AE Test initialisation 40000

4020x Pressure build-up with FPE/FPA in chamber flow

5. S-online Pressure Test

Prerequisites for Test:

Blood side must not be stopped by TLC or LLC. If stopped: Message 1140 is displayed. No timeout. Test code = 40 to LLS Test code = 40 back t o LLC

through mode via DDE unt i l P A > 270 mmHg (no pressure control for pressure sensor PA!) Valve Status: VDFF, VDE, VDA, V S B, VSAA ------------------closed VBP, VSAE ---------------------------------opened Timeout

20 s

Valve Status

VSAE closed, BPA and OSP stopped

LLC Test Steps LLS Test Steps LLS Test

If the substitution line s-online is connected at the beginning of th e blood side self test and the filling of the tubing system is performed by the machine (autopriming): LLC performs a pressure test of the port connectors and the lines between the port and OSP. This tubing is connected with the pressure sensor PA via the arterial tubing adapter. The test is performed with positive pressure. The build-up is performed in the DFS system with FPE/FPA via a pressure drop at the throttle DDE and an opened VSAE. The pressure test is performed for sonline after the equality test of the pressure sensors in the blood side test block. If autopriming is not performed s-online can not be tested. As an information LLS generates an alarm

Leakage Check S-Online

after the initial start of OSP in therapy. This information is generated even if the autopriming of the s-online test was not performed by LLC. If the s-online is not connected during the pressure test this is not detected and a message to check the line is not generated after connection and the start of online. 40 1 1166:

Self test substitution line failed

Return to window: Repeat blood line self test with

Start condition for the test (for 5 s):

1. Correct valve position (VSAE closed)

2. PA > 250 mmHg 3- PA < 500 mmHg

key.

Code

40001 – 40010

4020x Wait for B24OFF (timeout 30 s)

4030x Wait for B24ON (timeout 15 s)

10.

4070x (Error) the test prerequisites from HDFonline task are

11.

not given during one of the test steps (e.g. autopriming, HDF filter rinsing required after LF error).

4099x Completed

12.

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Test 10 s, Averaging MeanPA, Determine MinPA and MaxPA Check –500 mmHg < PA < 500 mmHg, max. deviation ∆PA < 50 mmHg,

-450 mmHg < PA < 450 mmHg, Check:

- MaxPA - MeanPA < 50 mmHg,

- MeanPA - MinPA < 50 mmHg Acknowledge with switch-off VGB

VGB ON 40019

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40011

40012

40013 – 40018

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Dialog

SW 9.xx

3. Repair Instructions 1/2010 3 - 36

3.3.17 Blood Side Pressure Retention Test

Objective Test code

Repeats until error message

ID error message

Actions after error

LLC Test

Code

3302x

3300x Stop BPA Test initialisati on 33000

3310x Set BPA w i t h ramp t o d elivery rate 200 ml/min,

3330x Wait for PV > + 400 mmHg for 500 ms during the

3340x Evaluate eve ry 250 ms c o nt i nuo us mean value from

10.

11.

3340x Wait for inversion of LLS_SELFTESTBIT from LLS

12.

13.

14.

3350x Wait for inversion of LLS_SELFTESTBIT from LLS

15.

Prerequisites for Test:

Blood side must not be stopped by TLC or LLC.

If stopped: Message 1140 is displayed. No timeout. If BS is not stopped HDFonline task mu st enable

the start of the tests. A delay occurs only with autopriming (set pressure). Timeout 2 min

Test code = 33 to LLS Test code = 33 back t o LLC

opened SAKV Timeout 90 s since subcode 100

running of BPA. Pressure reached:

- Stop BPA, close SAKV, open VBT

- Initialise mean value storage for PA, PV, PBS and PBE

Timeout 90 s since the start of subcode 100 the 4 values of PA, PV, PBS and PBE.

Evaluate after 2.5 s mean values of PBS and PBE:

PBE connected, if

PBE mean value is min. 100 mmHg hi g her (from BS pressure test) than PBE mean value (from BS equality test of pressure sensors) and PBE and PV mean value deviate less than ± 40 mmHg (from BS equality test).

PBS connected, if

PBS mean value is min. 100 mmHg higher (from BS pressure test) than PBS mean value (from BS equality test of pressure sensors) and PBS and PV mean value deviate less than ± 40 mmHg (from BS equality test). |PA - PV| ≤ 20 mmHg

(Timeout 35 s since start of subco d e 400) Close VBT Test VB T c l o s ed 33039

LLC Test Steps LLS Test Steps LLS Test

Pressure test of tubing system and control of the dynamics of the pressure sensors. 33 3 1169:

Blood side leakage test not OK

Return to window: Repeat blood line self test with

Test SAKV opened 33001

Test of BPA delive ry rat e at 185 ml /min < BPA < 215 ml/min Acknowledge by closing SAKV and saving PV Test of BPA motor speed (Note: the motor pulses are used for alarm evaluation when detecting standstill.) Wait for PV > 390 mmHg no timeout

Opened SAKV 33024-

PBE present, if: PBE ≥ PBE +100 mmHg from test 32, ste p 4 PBS present, if: PBS ≥ PBE +100 mmHg from test 32, ste p 4 Terminate if PBS not present for SNCO PV ≥ PV + 100 mmHg from test 32 step 20 Test SAKV closed, sav e P V 33027 Test 10 s PV pressure drop < 20 mmHg and P V > 150 mmHg and |PA - PV| ≤ 20 mmHg otherwise return to 54 Acknowledge with inversion of LLS_SELFTESTBIT

|PA - PV| ≥ 200 mmHg Acknowledge with inversion of LLS_SELFTESTBIT

key.

Code

33013

33014

3301533023

33025

33026

33028 33038

33040

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3360x (Error) the test prerequisit e s fro m HD F o nli ne t ask are

16.

3370x (Error) during start up of BPA (subcode 200), PV >

17.

3399x Completed 33041

18.

SW 9.xx

(Timeout 10 s since start of subco d e 400) not given during one of the test steps (e.g.

autopriming, HDF filter rinsing required after LF error). +400 mmHg

3. Repair Instructions 1/2010 3 - 37

3.3.18 Disinfection Valve VD

Objective

Test code

Repeats until error message

ID error message

Actions after error

LLC Test

Code

1. Prerequisites for Test: None

3710x Opened V D Test initialisation 37000

4. Start condition for the test:

3720x Close VD aft er 750 ms

3730x Wait for B24OFF (timeout 7.5 s)

3730x Wait for B24ON (timeout 5 s)

10.

3780x (Error) at start of test one or both couplings connected

11.

3799x Completed

12.

Test code = 37 to LLS Test code = 37 back t o LLC

to rinsing bridge.

LLC Test Steps LLS Test Steps LLS Test

Function test of the detection of the actual value for LLS. The disinfection valve VD is opened shortly (t < 3 s) by LLC during the test. The opening must be detected by LLS. The test is performed in rinsing bridge anymore and the blood side pressu re r etention test was passed. If th e test is not passed therapy is not possible. 37 3 1165:

Self test VD failed

None (repeat test until passed).

Preparation

BS pressure retention test is passed (test code 33)

Detection val ve opened 37002

Detection valve closed. The detected opening is acknowledged by the switch-off of VGB.

VGB ON 37010

if the dialyser couplings are not connected to the

Code

37001

37003 – 37009

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B. Braun Avitum AG

(

)

Dialog

3.4 LX800 Motherboard

SW 9.xx

3. Repair Instructions 1/2010 3 - 38

The Dialog+ (software 9.xx) uses the LX800 motherboard. A compact flash card CFC is connected to the motherboard. The BIOS is described in paragraph 3.3.5.

LVDS

(connector only, LVDS adapter integrated on LX800)

Power

JCFSET1

Setting CFC

6 4

5 3

JWP Write Protect

Enable write protect

3 2

Disable write protect

2 1

Battery

3 V

JLVDSPWR TFT Power

3.3 V: BoeHydis/Samsung 2

4 6

3 5

5 V: Philips

1 3 5

JBAT CMOS

Normal CMOS

1 2

Clear CMOS

2 3

Speaker

Black

5 3 1

(connector with out code Pin)

Black

7 5 3 1

Hard Disk Drive

USB8

USB7

USB6

USB5

USB4

USB1

HDD

Floppy Disk Drive

FDD USB2

USB1 Service SW/FSU

COM2

(DIABUS)

COM3

(ABPM)

VGA

COM4

(Touch Screen)

LPT

(FPB)

COM1PS/2

USB3

Type A

BA-TE-DE08C M.KAY

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B. Braun Avitum AG

B.Braun Dialog+ Service manual 1

Specifications and Main Features

Frequently Asked Questions

User Manual