Dialog+ SW 9.xx 5.

Technical Safety Inspection and Preventive Maintenance 1/2010 5-1

Copyright This document is the property of B. Braun Avitum AG with all rights reserved.

Service 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.

Prevent Electrical Shock Hazard 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.

ESD Information Pay attention to ESD information, because electronic components are sensitive to electrostatic
discharges.

High Voltage If a battery option is present in the machine:

in TFT Monitor 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.

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+ 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.

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+ 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: TSM Main Menu, File Operations, Save
Calibration Data.
Connection and Operation Service Board The service board must only be operated in the TSM service program. If the service board is
connected to the Dialog+ it is prohibited to connect a patient to the Dialog+ and to run a
therapy.

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.

Cover in Rear Door 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
assembled SMPS-MC.

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).

Fuses 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.

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

Ambient Temperature Before the Dialog+ is switched on the machine must have room temperature (see operating
manual, chapter 15).

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Dialog+ SW 9.xx 5. Technical Safety Inspection and Preventive Maintenance 1/2010 5-2

Table of Contents Page

5.1 Check List for Technical Safety Inspection and Preventive 5-3
Maintenance
5.1.1 Measurement Circuits for the Measurement of the Electrical 5-7
Safety According to EN 62353/60601-1
5.2 Inspection Protocol for Automatic Blood Pressure Measurement 5-8
ABPM together with the Dialog+
5.2.1 Execution Procedure for Measurement Inspection ABPM 5-9

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Dialog+ SW 9.xx 5. Technical Safety Inspection and Preventive Maintenance 1/2010 5-3

5.1 Check List for Technical Safety Inspection

and Preventive Maintenance
For Dialog+ SW 9.xx The technical safety inspection shall be performed and documented every 12 months, according to
the specified check list and with reference to the service manual and instructions for use.
The preventive maintenance is recommended every 12 months, according to the specified check
list and with reference to the service manual and instructions for use and shall be documented.

REF {Type/Typ}: ........................................ SN {Serien-No./Nr.}: .................................................

Year of Purchase: ................... Responsible Organisation (User): .................................................

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

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

SW Version: ...............................................
Manufacturer: B. Braun Avitum AG
34209 Melsungen, Germany

Check List (S = Technical Safety Inspection Points; M = Preventive Maintenance Points)

S M NO YES OK
Note: Text in { } brackets is information for the execution of the check list!
Technical Safety Inspection 
Technical Safety Inspection with Preventive Maintenance 

1. Disinfection/decalcification was performed   

M

2. Visual Inspection with Maintenance Procedures

S 2.1 Visual Inspection   
{Machine: clean/complete; no damages/moisture influences (protection covers) or loose assemblies; no moveable parts
touching tubings or wires; casters are moveable; type plate legible}
M 2.2 Clean interior space and exterior surfaces   
M 2.3 Suction tubing for disinfection and concentrate exchanged    
M 2.4 O-rings at suction rod exchanged    
M 2.5 Balance chamber – no visible leakages   
S 2.6 Check tight seat and damages of mains supply (power supply cord, strain relief), potential equalisation cable, staff call/data   
lines (if present) and connectors
M 2.7 Tubing connectors , clamps and couplings (internal/external) are assembled correctly   
M 2.8 Membranes, o-rings and tubings at the dialyser couplings exchanged    
M 2.9 HDF Online Option present   
2.9.1 O-rings {12.37 x 2.62} and membranes {for HDF filter with couplings} exchanged    
2.9.2 Hydrophobic filter HFB exchanged    
2.9.3 Filter FSU {between PSABF and VSAA} exchanged    
M 2.10 DF Filter Option present   
2.10.1 Membranes exchanged    
M 2.11 Tight seat of boards and connectors (incl. mains connection in switch mode power supply)   
2.12 Exchange dust filter of fan (rear door)    
M 2.13 Filter (FVD, FB, FK, FBK1/2, FBIC, FEP) exchanged    
M 2.14 Filter level regulation module (HFA, HFV, HFE (HFS if present)) exchanged    
M 2.15 BIC Cartridge Holder Option present   
2.15.1 O-rings exchanged    
M 2.16 Battery on PC motherboard exchanged (after operating period of 4 years)   
{Battery is not included in the maintenance kit, if necessary order separately.}
M 2.17 Monitor: no restriction of motion of rotation; touch membrane/keyboard membrane not damaged   
M 2.18 Check non-return valve RVDA (400 mbar ±50 mbar or 300 mmHg ±37 mmHg) and set if necessary   
(for HDF Online: 500 mbar ±50 mbar or 375 mmHg ±37 mmHg)
M 2.19 Check non-return valve DDE (400 mbar ±50 mbar or 300 mmHg ±37 mmHg) and set if necessary   
M 2.20 Check non-return valve RVFPE (1,300 mbar ±50 mbar or 975 mmHg ±37 mmHg) and set if necessary   
M 2.21 Check non-return valve RVFPA (1,300 mbar ±50 mbar or 975 mmHg ±37 mmHg) and set if necessary   

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Dialog+ SW 9.xx 5. Technical Safety Inspection and Preventive Maintenance 1/2010 5-4

Check List (S = Technical Safety Inspection Points; M = Preventive Maintenance Points)

S M NO YES OK
Note: Text in { } brackets is information for the execution of the check list!
M 2.22 Conductivity Sensors
2.22.1 ENDLF sensor: Visual inspection   
2.22.2 BICLF sensor: Visual inspection   
M 2.23 Piston Pumps
2.23.1 BIC piston pump: Visual inspection   
2.23.2 KP piston pump: Visual inspection   
M 2.23.3 UF piston pump: Visual inspection   
M 2.24 Blood leak detector (BLD) test passed   
2.24.1 Check blood leak detector and calibrate if necessary    
M 2.25 Degassing Pressure Sensor PE (permissible tolerance ±13 [mbar])

- Comparison measurement (at approx. -530): Measurement instrument: ........................ Display on machine: ....................... [mbar] 

- Comparison measurement (at approx. -130): Measurement instrument: ........................ Display on machine: ....................... [mbar] 
M 2.26 Dialysate Outlet Pressure Sensor PDA (permissible tolerance ±13 [mbar])

- Comparison measurement (at approx. -530): Measurement instrument: ........................ Display on machine: ....................... [mbar] 

- Comparison measurement (at approx. 0): Measurement instrument: ........................ Display on machine: ....................... [mbar] 

- Comparison measurement (at approx. +530): Measurement instrument: ........................ Display on machine: ....................... [mbar] 
M 2.27 Heparin Pump

2.27.1 Position (80 mm ± 15 mm) {Drive fast forward to end position with 30 ml syringe. Check display position in mm.} ....................... [mm] 
M 2.28 Set summer/winter time {TSM, Treatment Support, System Configuration, if applicable in this country}   

3. Function Inspection (Document Measurement Values)

S 3.1 Blood Pump: - Check function, moveability, noise rating 
3.1.1 - Check roller/one-way bearing; clean and lubricate shaft slightly if necessary 
3.1.2 - Alarm cover switch 
S 3.2 Single-Needle Pump: Option present   
3.2.1 - Check function, moveability, noise rating 
3.2.2 - Check roller/one-way bearing; clean and lubricate shaft slightly if necessary 
3.2.3 - Alarm cover switch 
S 3.3 Venous Tubing Clamp SAKV: - Function/gap checked, set gap 1.4 (+0.1 mm) if necessary 
S 3.4 Arterial Tubing Clamp SAKA: Option present   
3.4.1 - Function/gap checked, set gap 1.4 (+0.1 mm) if necessary 
S 3.5 Arterial Pressure PA: (permissible. tolerance ±10 [mmHg])

Comparison measurement (at approx. -400): Measurement instrument: ........................ Display on machine: ..................... [mmHg] 

Comparison measurement (at approx. 0): Measurement instrument: ........................ Display on machine: ..................... [mmHg] 
S 3.6 Inlet Pressure PBE: (permissible. tolerance ±10 [mmHg])

Comparison measurement (at approx. 0): Measurement instrument: ........................ Display on machine: ..................... [mmHg] 

Comparison measurement (at approx. +400): Measurement instrument: ........................ Display on machine: ..................... [mmHg] 
S 3.7 Venous Pressure PV: (permissible. tolerance ±10 [mmHg])

- Comparison measurement (at approx. 0): Measurement instrument: ........................ Display on machine: ..................... [mmHg] 

Comparison measurement (at approx. +400): Measurement instrument: ........................ Display on machine: ..................... [mmHg] 
S 3.8 Single-Needle Pressure PBS: (permissible. tolerance ±10 [mmHg]) Option present   

- Comparison measurement (at approx. 0): Measurement instrument: ........................ Display on machine: ..................... [mmHg] 

- Comparison measurement (at approx. +400): Measurement instrument: ........................ Display on machine: ..................... [mmHg] 

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Dialog+ SW 9.xx 5. Technical Safety Inspection and Preventive Maintenance 1/2010 5-5

Check List (S = Technical Safety Inspection Points; M = Preventive Maintenance Points)

S M NO YES OK
Note: Text in { } brackets is information for the execution of the check list!
S 3.9 Staff Call: Option present   
3.9.1 - Function or contact continuity passed   
S 3.10 Automatic Blood Pressure Measurement ABPM: Option present   
3.10.1 - ABPM inspection protocol performed {see separate ABPM inspection protocol, paragraph 5.2}   

4. Electrical Safety Check According to EN 62353/EN 60601-1

S 4.1 Protective Earth Resistance:
< 0.3 [Ω] {note highest value}: ...................... [Ω] 
{(Machine incl. 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 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}
S 4.2 Equipment Leakage Current:
{All water connections and data lines must be connected during the check (see figure 2) of the equipment leakage current.}

≤ 0.5 [mA]: - During heat-up phase {change mains polarity and note highest value}: .................... [mA] 
S 4.3 Patient Leakage Current:
{All water connections and data lines must be connected during the check (see figure 3) of the patient leakage current.}
≤ 10 [µA] DC: - Under normal conditions {at dialyser coupling}, conductivity at 13 - 15 mS/cm: ..................... [µA] 
≤ 10 [µA] AC: - Under normal conditions {at dialyser coupling}, conductivity at 13 - 15 mS/cm: ..................... [µA] 

5. Setting into Service According to Instructions for Use

S 5.1 Applied Accessories/Disposables: Applied line system:
Name: ........................................................................................................................................
S 5.2 Switch on machine: - Self-test passed 

S 5.3 Power Fail Function:

{Activate buzzer in power supply, i.e. switch on machine for approx. 5 minutes and then disconnect mains plug.}
- Check function, duration of a constant audible alarm > 1 minute 

S 5.4 Temperature: - Comparison measurement {at dialyser coupling}, at 37 oC (-1.5; +0.5): .......................... [oC] 

S 5.5 Conductivity: - Comparison measurement {at dialyser coupling, e.g. 14.3 mS/cm (±0.2)}: ................. [mS/cm] 

S 5.6 Safety Air Detector (SAD): - Test alarm function (visual/audible) passed 

S 5.7 Monitor
5.7.1 Function of the keys, display illumination, OSDs (for Dialog+) and touch screen OK 
5.7.2 Image display OK 
S 5.8 Ultrafiltration:
{see chapter 3 Measures after Repair, paragraph 3.8.2.5 Test Run UF Comparison Measurement}
- Comparison measurement at 15 min with UF rate 500 ml/h (125 ml UF volume ±15 ml) :

Display on machine: ................................ Meas. instrument: ......................................... [ml] 

S 5.9 Battery Option: Option present   
5.9.1 - Activate audible alarm   
{The machine must be in therapy mode. Disconnect mains plug: The buzzer from the SMPS-MC gives three signalling tones as
an indication that the machine is running in battery mode.}
M 5.10 Disinfection: - Perform by responsible organisation {user}   
{inform responsible organisation}
- Performed by service technician   

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Dialog+ SW 9.xx 5. Technical Safety Inspection and Preventive Maintenance 1/2010 5-6

Check List (S = Technical Safety Inspection Points; M = Preventive Maintenance Points)

S M NO YES OK
Note: Text in { } brackets is information for the execution of the check list!

Applied Measurement Equipment:

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

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

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

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

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

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

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

Template 1.4/1.5: ................................................................................. * 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

CHECK RESULTS:
Customer specific parts or information on the machine (e.g. stickers/labels) were removed during the technical
safety inspection/preventive maintenance or repair:   
New labelling must be performed by responsible organisation (user):   

Results of Test and Evaluation: 2 1 0 

0 = no deficiencies; 1 = minor deficiencies; 2 = deficiencies requiring repair

Comments:
.............................................................................................................................................................................................................................................................
.............................................................................................................................................................................................................................................................
.............................................................................................................................................................................................................................................................
The technical safety inspection/technical safety inspection with preventive maintenance was passed:   

Next Inspection Date: ................................................................................................................................................................

The technical safety inspection/technical Name Service Technician/Company:
safety inspection with preventive ................................................................................................................................................................
maintenance was performed correctly.
................................................................................................................................................................
Date / Signature

{ Maintenance Kit}
{A maintenance kit can be ordered for the technical safety {Art. No. Description}
inspection with preventive maintenance of a Dialog machine. All
parts are included which are recommended for exchange during a {3451893D Maintenance Kit}
preventive maintenance.}

{ Maintenance Kit/Supplement HDF Online}

{A second maintenance kit can be ordered for the technical safety {Art. No. Description}
inspection with preventive maintenance. As a supplement this kit
includes all parts recommended for exchange during a preventive {34560686 Maintenance Kit/Supplement HDF Online}
maintenance of a HDF online machine.}

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Dialog+ SW 9.xx 5. Technical Safety Inspection and Preventive Maintenance 1/2010 5-7

5.1.1 Measurement Circuits for Measurement of Electrical

Safety According to IEC 62353/60601-1
Protective earth (ground)

L, N Supply mains terminals PE Protective earth terminal

MP Mains part AP Applied part

MD Measuring device M Residual current meter with frequency

response as MD

Resistance measurement equipment

Part of enclosure not protectively earthed Connection to accessible conductive parts

Table 1: Legend of Abbreviations and Symbols

Protective Earth Resistance

L MP AP
Test current: ≥ 200 mA
The test current must be measured in both
N directions.
PE

Fig. 1: Protective Earth Resistance

M Equipment Leakage Current:

L(N) MP AP
• Differential Measurement
L

N
N(L)

PE
Fig. 2: Equipment Leakage Current

Patient Leakage Current

L MP AP

N
PE

MD
Fig. 3: Patient Leakage Current

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Dialog+ SW 9.xx 5. Technical Safety Inspection and Preventive Maintenance 1/2010 5-8

5.2 Inspection Protocol for Automatic Blood Pressure

Measurement ABPM
Measurement Inspection The measurement inspection is recommended every 12 months and should be
documented. The measuring methods are described in the execution procedures.

Dialysis Machine Dialog REF {Type/Typ}: ........................................... SN {Serien-No./Nr.} .............................................

Automatic Blood Pressure ABPM Module M2009/2010
Measurement ABPM

Manufacturer B. Braun Avitum AG, 34209 Melsungen, Germany

Responsible Organisation (User) Address: ..............................................................................................................................................................

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

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

1. Visual Inspection - Tight seat of all connectors : ----------------------------------------------- OK 

- No damages which could affect the function or the safety
(incl. tubing and cuff): ------------------------------------------------------ OK 
2. Limits of Error of the Pressure Admit a static pressure to the machine.
Indication
Pressure [mmHg] Measurement Values Deviation
Dialog Reference [mmHg]
290
200
100
50
0
The permissible tolerance for each measurement is:
ABPM Module: -------------------------------------------------- ± 3 mmHg: OK 

3. Air Leakage
Initial Pressure Final Pressure Air Leakage
[mmHg] [mmHg] [mmHg]

Pressure drop ABPM Module: -------------------------- ≤ 18 mmHg in 3 min: OK 

4. Rapid Exhaust - Time for pressure reduction from >260 mmHg to <15 mmHg max. 10 s: ........ s OK 
- Trigger of rapid exhaust between 300 mmHg and 330 mmHg: ---------------- OK 
5. Function Inspection The results of a measurement on a test person are plausible -------------------- OK 
6. Result of Inspection The blood pressure measurement module has passed the
measurement inspection: -------------------------------------------- No  Yes 

Comments: ........................................................................................................................................................

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

The measurement inspection was Name Service Technician:

performed correctly. ................................................................................................................................................................................

................................................................................................................................................................................
Date / Signature

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Dialog+ SW 9.xx 5. Technical Safety Inspection and Preventive Maintenance 1/2010 5-9

5.2.1 Execution Procedure for Measurement

Inspection ABPM
• Reference pressure instrument (accuracy ≤ 0.8 mmHg)
• Measurement chamber with 500 ml volume (rigid metal
vessel, e.g. art. no. 7703090)
• Syringe 50 ml (for pressure build-up)
• Stopcock system incl. tubing (e.g. art. no. 770203A)
• Pressure tubing
Activate the ABPM Maintenance menu with the ABPM
Maintenance key in TSM Service Program, TL Manual Test and
Calibration.
The ABPM Maintenance menu is used for the function test of the
Dialog automatic blood pressure measurement ABPM option.

To Point 2: Limits of Error of the Pressure Indication Measurement according to EN 1060-1:1995 and EN 1060-
3:1997.

Reference Instrument 1. Connect all components according to figure (set stopcock

system according to figure).

Measurement 2. Switch on Dialog in TSM service program.

Chamber
3. Select in TSM Manual Test and Calibration, TTL Manual Test
ABPM and Calibration and then ABPM Maintenance.
500 ml

4. Press button.
Wait until a pressure build-up of approx. 170 mmHg (start of
pressure retention phase).
Pressure Tube
5. Increase the test pressure to 290 mmHg (± 10 mmHg) with
1 2 3 4 the syringe. Read the value displayed on the Dialog and close
50 ml
stopcock 4 immediately. Now read the value on the reference
Stopcock System 50 ml Syringe
instrument and enter in table.
Fig.: Inspection Set-up for Compliance of Error Limits of the
Measurement Display
6. Decrease pressure according to test points and enter values in
table.
7. Enter deviations in table.

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Dialog+ SW 9.xx 5. Technical Safety Inspection and Preventive Maintenance 1/2010 5 - 10

To Point 3: Air Leakage

1. Set-up and connect ABPM according to figure.
Measurement
Chamber
ABPM 2. Press button.
A test pressure of approx. 200 mmHg is automatically built up
(test duration 4 minutes).
500 ml
3. Enter values in table after test is expired.
The values are displayed after the time has elapsed:
The Initial Pressure, Final Pressure and Leakage are displayed
in the ABPM Maintenance menu point 4.
Pressure Tube Pressure drop ABPM module:------------------------ ≤ 18 mmHg
Fig.: Inspection Set-Up for Inspection of Air Leakage

To Point 4: Rapid Exhaust

Reference Instrument

1. Press button.
Measurement Wait until a pressure build-up of approx. 290 mmHg (start of
Chamber pressure retention phase).
ABPM 2. Increase slowly pressure to > 300 mmHg with the syringe
500 ml
until valve opens for rapid exhaust.
3. The valve for rapid exhaust must open between 300 and 330
mmHg. The indicated time for the pressure drop must not be
exceeded.
Pressure Tube Pressure reduction from >260 mmHg to <15 mmHg:----- max. 10 s

1 2 3 4
50 ml

Stopcock System 50 ml Syringe

Fig.: Inspection Set-up for Rapid Exhaust

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