TI 2018 - 01 Software Version 9.1A (EN)
TI 2018 - 01 Software Version 9.1A (EN)
TI 2018 - 01 Software Version 9.1A (EN)
xx
Technical Information EN 01/2018
Software 9.1A, Rev 1.00.00/February 2018
11Dialog+
Dialog+ SWSW 9.xx
9.xx Software
Software 9.19
9.1A Technical
TechnicalInformation
Information07/2017
01/2018
Copyright
This document is the property of B. Braun Avitum AG with all rights reserved.
Commissioning and Service
Only trained personnel must service the Dialog+, i.e. repair, maintenance, software
installation, firmware update, retrofitting and commissioning of the Dialog+ SW 9.xx.
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.
Prevent Electrical Shock Hazard
Switch off the Dialog+ SW 9.xx 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+
SW 9.xx can cause serious injury or death.
ESD Information
Pay attention to ESD information, because electronic components are sensitive to
electrostatic discharges.
High Voltage in TFT Monitor
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.
Protective Conductor in TFT Housing
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.
TSM Service Program
Only activate the TSM service program for service activities. It is prohibited to connect a
patient to the Dialog+ SW 9.xx and to run a therapy if the TSM service program is
activated in the Dialog+ SW 9.xx. 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.
Software
The software is installed in the software mode: digital board, service switch S1, position 3.
Therapy Mode
After completion of all procedures switch back to the therapy mode: digital board, service
switch S1, position 0.
Calibration
Only perform a calibration after the Dialog+ SW 9.xx has reached working temperature
and the machine was disinfected and decalcified. Save the calibration data (CFC) before
you exit the TSM service program: TSM Main Menu, File Operations, Save Calibration Data.
Tubing
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
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).
Prevent Chemical Burns and Scalding
During servicing on running machines: prevent chemical burns and scalding of the skin due
to the penetration of disinfectant or hot liquid.
Contaminated Machines
Protective gear should be worn in case of servicing of assumed contaminated machines.
General Information 6
Software 9.1A for Dialog+ SW 9.xx 6
Ordering Numbers 6
1. Hardware and Software Status 7
2. Software Modifications 8
2.1 Software Modifications from SW 9.12 to SW 9.13 8
2.2 Software Modifications from SW 9.13 to SW 9.16 8
2.3 Software Modifications from SW 9.16 to SW 9.17 9
2.4 Software Modifications from SW 9.17 to SW 9.18 9
2.5 Software Modifications from SW 9.18 to SW 9.19 10
2.6 Software Modifications from SW 9.19 to SW 9.1A 10
3. Hardware Modifications 11
3.1 Modification Matrix 11
3.2 Flow Diagrams (from SW 9.19) 12
3.2.1 Dialog+ with BIC Option and TSDE-S 12
3.2.2 Dialog+ with BIC Option, DF Filter Option and TSDE-S 13
3.2.3 Dialog+ HDF Online with TSDE-S (Molded Air Separator LA) 14
3.2.4 Dialog+ HDF Online with TSDE-S (Injection Molded Air Separator 15
LA)
4. Software Installation 16
4.1 After Installation of Software 16
4.2 Boot Machine/Check Version Number 16
4.3 Select Options 16
4.4 Enter Customer Specific Default Values 16
4.5 Enter Specific Parameters 17
5. Modified Calibration Procedures 18
5.1. Calibration of UF Pump 18
5.2. Calibration of Balance Chamber 19
5.2.1 Repair Matrix Balance Chamber 20
5.3 Calibration Procedure for TSBIC, TSD, TSD-S, TSDE-S and TSDE 21
5.3.1 Calibration Sensor Position for TSBIC, TSD, TSD-S, TSDE-S and 22
TSDE
5.3.1.1 Position of Measurement Sensor if TSDE-S/TSDE are Located at 22
Front
5.3.1.2 Position of Measurement Sensor if TSDE-S/TSDE are Located at 22
Rear
5.4 Calibration of Conductivity Sensors 23
6. Test Run with UF and Temperature Measurement 24
7. Structure TSM Service Program (from SW 9.16) 26
7.1 New/Modified Menus in TSM Service Program 27
TI_2018_01_DialogP_SW_9.xx_SW 9.1A_EN.doc/pdf Art. No. 38910436 Rev. 1.00.00/February 2018 4/50
11Dialog+
Dialog+ SWSW 9.xx
9.xx Software
Software 9.19
9.1A Technical
TechnicalInformation
Information07/2017
01/2018
Each machine is marked with a special sticker (included in the retrofitting kit) to indicate
the upgrade. The sticker has to be adhered to the Dialog+ logo on the monitor, covering
the original white plus (+) character.
Dialog+ machines with the software version 9.1A and the hardware upgrade ex factory are
delivered with a modified front panel membrane.
2. Software Modifications
2.1 Software Modifications from SW 9.12 to SW 9.13
Modifications Comments
1 Correction of the backup functionality on patient cards for increase of availability
bioLogic RR Comfort to be able to save more than 100 (relevant only for
therapies on the card. bioLogic RR Comfort)
2 Upline tank overflow due to unwanted open VZ in some TSM increase of availability
menus fixed.
Modifications Comments
1 The TSDE alarm monitoring was optimized. increase of availability
2 The temperature self test is repeated with the heater ON if increase of availability
the self test failed.
3 The alarm handling (LLC/LLS) for the temperature alarms increase of availability
was optimized.
4 Menu and selection for the pressure follower valve PFV was *extended function
introduced (for Development only).
* Does not affect existing control mechanisms, operating principles or performance specifications.
Modifications Comments
1 The temperature control was optimized. increase of availability
Modifications Comments
1 Purging of air from the DF filter every 150 seconds for 1 optimization
second, alarm if more than 2 VLA openings in 1 hour
2 Heparin pump: optimization
- control is optimized and earlier "Incorrect heparin rate"
warning for low heparin rates
- pump can only run in TSM with syringe correctly inserted
and syringe not empty
3 Disinfection valve VD is supervised during the disinfection increase of availability
cycle to prevent overflow of disinfectant due to open VD.
4 Supplement of the self test of substitution line optimized optimization
to detect also smaller leakage
5 Setting of date for daylight saving time (summer time) is optimization
corrected.
6 Clearing up of some Help texts optimization
Modifications Comments
1 Alarm delay for TSDE-S modified increase of availability
2 Monitoring of degassing pressure PE during disinfection increase of availability
modified to reduce unwarranted alarms “Emptying of
upline tank not possible”
3 bioLogic RR possible also in combination with Nexadia increase of availability
Power board valves PBV version 3 34562150 any SW version 9.xx from serial numbers -
218832
304349
Basic board BB version 3 34562168 any SW version 9.xx from serial numbers -
218832
304349
Injection molded components at 34562216 (injection injection molded parts not n/a
molded) compatible with milled Standard Machines
the UF sub-rack, i.e. air separator
34562215 (milled) version ≥ 230333
chamber and DDE holder
Standard Machines
≥ 503077
Rear door with mounting for VBE no spare part modified rear door n/a
(HDF online only) compatible with milled HDF Online
version, i.e. backwards ≥ 307941
compatible
Heater inlet temperature sensor - only with SW 9.17 and 9.18 Standard Machines Required
TSHE as dialyzer inlet temperature ≥ 232560*
sensor supervisor TSDE-S Standard Machines
≥ 504034*
HDF Online
≥ 308838*
*Some of these serial numbers of the transitional period might have software 9.12 with TSHE.
Confirm that the ratio values are correct and equal for the respective controller and
supervisor, especially for the new value of ENDLF Ratio, Actual Status Supervisor.
For Machines with Pump Head for 7x10 Blood Pump Segment only
The type of pump head has to be selected as 7x10 and saved after a software update.
Check and confirm that the values for the 7x10 tube constant are correctly set, i.e. 9293
µl/head rotation for 7x10 tubing segment.
The UF pump has to be calibrated prior to the balance chamber calibration. The calibration
procedure for the UF pump has changed from SW 9.18.
1. Clamp and remove outlet tubing from UFP. Connect another tubing (e.g. suction
tubing for disinfectant) to UFP outlet and immerse tubing into an empty container.
2. Press UF Pump START Calibration button to prime the tubing.
Wait a few seconds to fully prime the tubing.
3. Press again UF Pump START Calibration button to stop UFP.
The UFP will rotate back into its initial position.
4. Remove filled tubing carefully from container, measure weight and note value.
5. Immerse tubing carefully into container.
6. Press UF Pump START Calibration button to start calibration procedure.
The UFP runs approx. two minutes and stops. It will rotate back into its initial
position.
7. After UF pump has stopped, remove tubing carefully from container, measure weight
and note value.
8. Press Ref. Value button.
9. Enter calculated delivery volume as reference value:
second measurement – first measurement = delivery volume.
10. Press Calibration button to confirm.
11. Confirm and store completed calibration procedure with OK icon.
Note: The calibration data is saved only after the bit sequence 0-1-0.
12. To avoid air in the dialyzing fluid system, rinse the machine before starting the
balance chamber calibration (use e.g. Low Level Manual Test, 1.11 Dialysis
Temperature).
13. Activate Calibration button and wait until automatic calibration procedure is
completed. This will take a few minutes whereby the system automatically moves
both membranes into their end positions to determine the respective frequencies
(displayed in µs) and chamber volumes at those points.
The values will remain at 0 µs and the LLC Status will appear as 00000800 0000000
(Calibration error balance chambers) if the calibration process fails at one point, e.g. if min.
or max. values are outside the permitted range.
MSBK1 Minimum/Maximum µs Values
MSBK2 Minimum/Maximum µs Values
Check that the min./max. values for MSBK1 and MSBK2 are between 11,000 µs and
35,000 µs respectively.
• The minimum values of MSBK1/2 must be >11,000 µs
• The maximum values of MSBK1/2 must be <35,000 µs
Additionally, the difference between the min. value and max. value of each chamber must
be >5,500 µs.
A common calibration of all sensors for the dialysis temperature is recommended. The
supervisor sensors TSD-S and TSDE-S are always automatically calibrated together with the
respective controller sensors.
Refer to the procedure from the service manual, chapter 4 for the requirements and
settings, e.g. setting of pump speed and heater power.
The reference points remain the same, i.e. at 30 °C, 38 °C and 50 °C.
The loop-in positions of the temperature reference meter are changed.
Clamp
Clamp
The measurement sensor for the temperature calibration is connected between FPE and
TSDE-S, bypassing the balance chamber and DDE.
The filters on DF filter machines and HDF online machines are bypassed as well.
Clamp open tubings to avoid spillage.
Red
Measurement
Sensor
to
FBK1 Blue TSDE-S
TSDE
Clamp 1
to
TSDE-S
FBK1 Clamp 2
Fig.: Front view (the actual hardware might look differently, depending on the serial number)
5.3.1.2 Position of Measurement Sensor if TSDE/TSDE-S are Located at Rear
to
VDE FBK1
Clamp 1
Red
TSDE
Measurement
Sensor
TSDE-S FBK1
to Clamp 2 Blue
TSDE-S
Fig.: Rear view (the actual hardware might look differently, depending on the serial number)
Cover the open tubing ends with an absorbent cloth to prevent water spraying due to
pressure built-up in the balance chamber.
Secure all 4 tubing connections with tubing clamps to prevent accidental disconnection of
tubings due to high pressure and to prevent major damage on the electronics due to fluid
spillage.
A common calibration of all sensors for the dialysis fluid conductivity is recommended. The
supervisor sensor ENDLF-S is always automatically calibrated together with the respective
controller sensor.
Refer to the procedure from the service manual, chapter 4 for the requirements and
settings, e.g. setting of pump speed and heater power.
The reference points remain the same, i.e. at 0.0 mS/cm, 3.0 mS/cm, 5.8 mS/cm and 14
mS/cm.
The position of the reference meter is the same as for the temperature calibration, i.e.
between FPE and TSDE-S, bypassing the balance chamber and DDE.
The filters on DF filter machines and HDF online machines are bypassed as well.
Cover the open tubing ends with an absorbent cloth to prevent water spraying due to
pressure built-up in the balance chamber when opening the clamps.
After calibration:
Remove the reference meter and reconnect the tubing.
• connection filter FBK1 to balance chamber
• connection throttle DDE outlet (on standard and HDF online machines) or DF filter
outlet (on DF filter machines) to temperature sensor TSDE-S inlet.
WARNING
Wrongly installed temperature sensors on standard machine (without DF filter) and HDF
Online machines can lead to undetected high temperature fluid going to the dialyzer. Extra
test steps have to be performed during the test run to prevent this.
• Ensure that the temperature sensors TSDE and TSDE-S are correctly installed between
DDE and T-piece in machines without DF filter, i.e. in standard machines and HDF
Online machines.
• The temperature sensors shall not be installed between the T-piece and the valve VBP.
________________________________________________________________________
The test run should be performed under normal environmental condition, i.e. at a room
temperature of 25 °C ±5 °C.
1. Turn service switch S1 to position 0 - Therapy and close both doors.
2. Start machine (fully equipped) in dialysis mode.
3. Insert line system with dialyzer and prime and rinse with fluid – see instructions for
use, i.e. perform preparation (insert heparin syringe and select 2 ml/h and use BIC
cartridge if present).
4. Perform self test – according to instructions for use.
5. Connect a reference meter for temperature and conductivity in series with the
dialyzer (at blue coupling before dialyzer).
6. Set desired temperature to 37 °C and dialyzing fluid flow to 500 ml/min.
7. Set the UF volume to 125 ml and a therapy time to 00:20 h.
The machine must run without errors up to the message Connect Patient.
8. Press the Connect Patient icon to switch to therapy mode. This icon is enabled after
all self tests were performed successfully.
9. Insert the arterial and venous lines in a min. 250 ml container with water and make
sure that no air is drawn in.
10. Set the blood pump so that no blood side alarms are activated and circulate the blood
side.
11. Start therapy by switching from bypass to mainflow.
12. Stop blood pump after about one minute (the machine switches to bypass and UF
stops).
13. Remove blood lines from container.
14. Measure the weight of container filled with water and document as first value.
15. Document UF GROSS-S value from service overview as start value.
16. Insert arterial and venous lines into container with water again.
17. Start blood pump again and switch out of bypass.
18. After about 15 minutes in treatment check temperature sensor readings in Service
Overview screen and compare set temperature with reference meter. The set
temperature shall deviate no more than ± 0.5 °C from the temperature reading of the
reference meter and from TSDE/TSDE-S.
19. Check the conductivity for ENDLF by comparing with reference meter. The values shall
be within the tolerance of ±0.2 mS/cm.
20. Additional check for standard machines (without DF-filter) and HDF-Online machines
! only:
Check the values of the temperature sensors TSDE and TSDE-S in the Service
Overview in mainflow. Switch to bypass and compare the values of the temperature
sensors TSDE and TSDE-S again. The values shall not change more than 1.0 °C within
10 seconds, compared to the values in mainflow mode. A value change of more than
1.0 °C indicates that the temperature sensors might be assembled in the wrong
position and need to be reconfirmed.
Alarm signal
This new menu can be used by development to test the alarm and warning reactions in the
different therapy phases.
Phase
Selection of the Phase (e.g. Preparation, Therapy, Disinfection) which has to be tested.
Subsystem
Selection of Subsystem (e.g. TLC, LLC, LLS) which has to be tested.
Bit Number
Selection of Bit Number (alarm identification) which alarm shall be activated.
START
Test start.
7.1.3 Low Level Manual Test
9.1 Pop-up Window if bioLogic RR Comfort Guideline Curve could not be Saved
To ensure that the bioLogic RR Comfort guideline curve was recorded correctly (without any
issues), a new pop-up window was created:
bioLogic RR guideline curve of the current therapy is not saved
The possible reasons of a saving issue are display as well.
LLC Test LLC Test Steps LLS Test Steps LLS Test
Code Code
1. 3202x Prerequisites for Test:
a) Blood side must not be stopped by TLC or LLC.
If stopped: Message 1140 is displayed.
No timeout.
b) If BS is not stopped HDFonline task must enable
the start of the tests. A delay occurs only with
autopriming (set pressure).
Timeout 2 min
2. Test code = 32 to LLS Test code = 32 back to LLC
3. 3210x LLC opens SAKV, VBT, VPA, VPV, VPU and closes SAKA Test initialization 32000
VPU must be opened to prevent a pressure
equalization to the environment and that the levels
in the chambers do not change.
VPE remains closed to prevent a pressure
equalization if PBE is not connected.
4. 3220x Check of current detection for VBT, VPA, VPV, VPE, 32001
VPD, SAKA, SAKV and LRP
Test timeout 60 s and wait for inversion of
LLS_SELFTESTBIT from LLS Acknowledge with inversion of LLS_SELFTESTBIT
5. 3230x LLC closes VBT, VPA, VPV, SAKA
and opens VPE, SAKV, SAKA
6. 3240x Check of current detection for VBT, VPA, VPV, VPE, 32002
VPD, SAKA, SAKV and LRP
Test timeout 60 s and wait for inversion of
LLS_SELFTESTBIT from LLS Acknowledge with inversion of LLS_SELFTESTBIT
7. 3250x LLC closes VPE and VPU
VPD is opened
LRP is activated with the PWM PPRLOW (PWM for
line with small chamber, setting in TSM)
From SW 9.12
If AV-Line without PA Connector is selected, LLC
opens valve VBT to check PA and PV without PA
connection.
8. Initialize mean value storage for PA, PV, PBS and PBE Check of current detection for VBT, VPA, VPV, VPE, 32003
VPD, SAKA, SAKV and LRP