DialogAd SM Chapter 5-4-2002

Dialog/Dialog Advanced
5. Technical Safety Inspection and Preventive Maintenance 4/2002 5-1
Copyright This technical documentation contains confidential

information of B. Braun Medizintechnologie GmbH and may
not be copied, partly or whole, nor made accessible to third
parties without our written consent and remains with all
rights the property of B. Braun Medizintechnologie GmbH.
Service Only competent individuals that are trained in the repair,

maintenance and software installation of the Dialog/Dialog
Advanced should attempt to service the machine!
The servicing of the Dialog/Dialog Advanced in accordance
with this service manual should never be carried out in the
absence of proper tools, calibration equipment and the most
recent edition of this service manual, which must be clearly
and thoroughly understood!
Prevent Electrical Shock Hazard Switch off the Dialog/Dialog Advanced and disconnect unit
from mains before opening the machine!
Do not touch any exposed wiring or conductive surfaces
while the Dialog/Dialog Advanced is open. The voltages
present when electrical power is connected to the
Dialog/Dialog Advanced can cause serious injury or death!
If necessary open the machine for maintenance and repair
ESD Recommendations Pay attention to ESD requirements, because electronic

components are sensitive to electrostatic discharges (see
appendix)!
Fuses If fuses are replaced they must exactly match the type and
rating specified by the manufacturer. Where applicable: Fuses
must be approved by UL/CSA!
Calibration Only perform a calibration after the Dialog/Dialog Advanced

has reached working temperature!
MT-MD-DE08C M.KAY
DialogAd_sm_Chapter 5_4-2002.doc/pdf <280602> ddmmyy B. Braun Medizintechnologie GmbH
Seite
5. Technical Safety Inspection and 5-3
Preventive Maintenance
5.1 Inspection Protocol for Automatic Blood Pressure 5-7
Measurement ABPM
MT-MD-DE08C M.KAY
The technical safety inspection, according to the specified check list, must be performed and
documented every 12 months, with reference to the service manual and operating
instructions, which are subject to technical amendments.
The preventive maintenance with the exchange of wear and tear parts, is recommended
every 12 months and should be documented, according to the specified check list, with
reference to the service manual and operating instructions, which are subject to technical
amendments.
Art. No.: ....................................... Machine No.: .............................................
Year of Purchase: ........................ User: ............................................................
.................................................................................................................................
Operating Hours: ..................... h Inventory No.: ............................................
SW Version: ................................. HW Version: ...............................................
Manufacturer: B. Braun Medizintechnologie GmbH
Check List Note: Only calibrated measurement equipment must be used!

ESD recommendations must be applied!
Technical Safety Inspection .....................................................................................................................................................................................................................................
Technical Safety Inspection with Preventive Maintenance .............................................................................................................................................................
S M S = Technical Safety Inspection Points; M = Preventive Maintenance Points No Yes OK
M Disinfection/decalcification was performed

S 1. Heat Exchanger (option) without leakages (TSM, LLC Manual Test)
2.
Visual Inspection with Maintenance Procedures
S 2.1
Machine: clean/complete; no damages/moisture influences; unit rollers are moveable; machine record
book present; no special incidents; type plates and inscriptions legible, options present
M 2.1.1 Clean interior space and exterior surfaces
S 2.2 Check mains supply (power supply line and connectors)
M 2.3 Suction tubing for disinfection and concentrate exchanged b
M 2.4 O-rings in suction rod exchanged b
M 2.5 Tight seat of the tubing connectors, clamps and couplings
M 2.6 Dialyser coupling membranes, o-rings and tubings exchanged b
M 2.7 Tight seat of tubings, clamps and couplings of inlet and outlet tubings
M 2.8 Tight seat of boards and connectors
M 2.9 Fan in power supply clean (if necessary clean)
2.9.1 Exchange dust filter of fan (rear door) b
M 2.10 PC motherboard:
2.10.1 CPU fan exchanged (depends on hardware status)
(CPU fan not included in the maintenance kit, if necessary order separately.)
2.10.2 Battery or rechargeable battery on PC motherboard exchanged (after operating period of 4 years)
(Battery or rechargeable battery are not included in the maintenance kit, if necessary order separately.)
M 2.11 Monitor: no restriction of motion of rotation (and fan); tight seat touch membrane/keyboard
membrane
S 2.11.1 Function of the keys, display illumination and touch
2.11.2 Image display, geometry
2.11.3 Alarm activation
M 2.12 No cracks in covers (rear door cover, front cover and mains suppression cover)
M 2.13 Tight seat of ground terminals in frame, front door, rear door and sub-racks (if necessary order separately for sub-racks)
M 2.14 Check/set pressure reducer (DMV) to 1.3 bar
2.14.1 Check pressure non-return valves (RVDA, DDE, RVFPE, RVFPA)
M 2.15 Conductivity Sensors
2.15.1 ENDLF sensor: Visual inspection
2.15.2 BICLF sensor: Visual inspection
MT-MD-DE08C M.KAY
S M S = Technical Safety Inspection Points; M = Preventive Maintenance Points No Yes OK

M 2.16 Piston Pumps
2.16.1 BIC piston pump
2.16.1.1 Visual inspection
2.16.1.2 Check tight seat of driving elbow on motor axis (if necessary tighten screw)
M 2.16.2 KP piston pump
M 2.16.3 UF piston pump (TSM, LLC Manual Calibration, 2.8 Flow UF Pump)
2.16.3.3 Check one-way bearing (if present)
M 2.17 Check temperature sensors (TSBIC, TSD/TSD-S - TSM, LLC Manual Test): difference ≤ 0.5 oC
M 2.18 No visible leakages of balance chamber
2.18.1 Valves (VEBK1/2, VDEBK1/2, VABK1/2, VDABK1/2, VDE, VBP, VLA): Pressure test passed
M 2.19 Disinfection valvel (VD): if necessary exchange parts and calibrate
(Parts not included in the maintenance kit, if necessary order separately.)
M 2.20 Blood leak detector (BLD) test passed
2.20.1 Blood leak detector calibrated b
M 2.21 Pressure sensors water side (PE/PDA): Pressure test passed
(TSM, LLC Manual Test)
2.21.1 PE (permissable tolerance ±50 [mmHg]) Comparison measurement at: - 400 = .................. [mmHg]
- 100 = .................. [mmHg]
2.21.2 PDA (permissable tolerance ±50 [mmHg]) Comparison measurement at: - 400 = .................. [mmHg]
0 = .................. [mmHg]
M 2.22 Heparin Pump
2.22.1 Heparin Pump Comfort: Syringe recognition passed
(TSM, LLC Manual Test, 1.4 Heparin Pump, with 20 ml and 50 ml template)
2.22.2 Heparin Pump Compact: Check display position (80 mm ± 15 mm) ....................... [mm]
(Drive fast forward to end position with 30 ml syringe. Check display position in mm.)
M 2.23 Filter (FVD, FB, FK, FBK1/2, FBIC) exchanged b
M 2.24 O-rings in BIC cartridge holder (option) exchanged b
M 2.25 Summer/Winter Time Setting
(TSM, Treatment Support, System Configuration)
M 2.26 HDF Online: Filter (HFB) exchanged
(Filter not included in maintenance kit, if necessary order separately.)
S 2.27 SAKV Curentless Closed (Option)
2.27.1 O-ring for magnetic plate exchanged (O-ring not included in maintenance kit, if necessary order separately.)
2.27.2 Gap for magnetic plate 1.6 (± 0.05 mm)
3. Function Inspection (Document Measurement Values)

S 3.1 Blood Pump: - Check function, moveability, drive belt, noise rating
3.1.1 Check roller; if necessary lubricate bearings
3.1.2 Alarm cover switch
3.1.3 One-way bearing
MT-MD-DE08C M.KAY
S M T = Technical Safety Inspection Points; P = Preventive Maintenance Points No Yes OK

S 3.2 Single Needle Pump (Option): - Check function, moveability, drive belt, noise rating
3.2.1 Check roller; if necessary lubricate bearings
3.2.2 Alarm cover switch
3.2.3 One-way bearing
S 3.3 Venous Tubing Clamp: - Function and moveability
3.3.1 Gap 1.4 (+0.1 mm)
S 3.4 Arterial Tubing Clamp (Option): - Function and moveability
3.4.1 Gap 1.4 (+0.1 mm)
S
3.5 Arterial Pressure PA - Comparison measurement at: - 400 = .................. [mmHg]
(permissable tolerance ±12 [mmHg]) 0 = .................. [mmHg]
S
3.6 Inlet Pressure PBE - Comparison measurement at: 0 = .................. [mmHg]
(permissable tolerance ±12 [mmHg]) + 400 = .................. [mmHg]
S
3.7 Inlet Pressure PBS (Option): - Comparison measurement at: 0 = .................. [mmHg]
S
3.8 Venous Pressure PV: - Comparison measurement at: 0 = .................. [mmHg]
S 3.9 Mains Failure Interruption: - Check function and alarm tone

S 3.10 Staff Call (Option): - Function or contact continuity passed
S 3.11 BIC Cartridge Holder (Option): - Check reed sensors (BKUS and if present BKOS)
(TSM, LLC Manual Test)
S 3.12 Automatic Blood Pressure Measurement ABPM (Option) - Check ABPM option, see 5.1)
S 3.13 Balance System HDF Bag (Option) (Switch to therapy, document applied reference weight and controller value from service overview)
3.13.1 Load cell comparison measurement (with reference weight) at: + ____.______ g = ........................... [g]
(permissable tolerance ± 50 g) Difference between Reference/Actual Value = ____________ [g]
3.13.2 Load cell comparison measurement (without reference weight) at: 0 g = ........................... [g]
(permissable tolerance ± 50 g) Difference between Set/Actual Value = ____________ [g]
M 3.14 DF Filter/Pyrogen Filter (Option): - Visual inspection passed
4. Electrical Safety Check According to EN 60601-1/IEC 601-1

S 4.1 Measure mains voltage: ........................ [V~]
S 4.2 Protective earth conductor resistance < 0.2 [Ω] - Potential equalization bolt .......................... [Ω]
(Machine incl. power supply line) - Screw connection heater body .......................... [Ω]
- Rinsing bridge (dialyser inlet and outlet) .......................... [Ω]
Staff Call (Option) - Rear door socket .......................... [Ω]

Substitution/HDF (Option) - Bag holder .......................... [Ω]
S 4.3 Earth leakage current ≤ 0.5 [mA] - During heat-up phase ....................... [mA]
S 4.4 Patient leakage current < 0.1 [mA] - Under normal conditions ....................... [mA]
(Conductivity at 14 mS/cm)
MT-MD-DE08C M.KAY
S M T = Technical Safety Inspection Points; P = Preventive Maintenance Points No Yes OK
5. Setting into Service According to Operating Instructions

S 5.1 Switch on Machine: - Self-test passed
S 5.2 Temperature - Comparison measurement at 37 oC (-1.5; +0.5) ......................... [oC]
S 5.3 Conductivity - Comparison measurement at dialyser coupling,

e.g. 14.3 mS/cm (±0.2) .................. [mS/cm]
S 5.4 Saferty Air Detector (SAD): - Test alarm function passed
S 5.5 Ultrafiltration - Comparison measurement at UF rate 500 (±15) ...................... [ml/h]

M 5.6 A disinfection was performed by: - User
- Service technician
CHECK RESULTS: Defects were detected, which could endanger patients, users or third parties.
Applied Accessories/Disposables: .................................................................................................................................
.................................................................................................................................
Must actions be taken with reference to maintenance
Note next appointment: .................................................................................................................................
The technical safety inspection or technical Name of Service Technician: Name of Company:
safety inspection with preventive maintenance ......................................................................
was performed correctly.
...................................................................... .......................................................
Date / Signature
User:
......................................................................
Date / Signature
b Maintenance Kit Dialog

A maintenance kit can be ordered for the Dialog technical safety Art. No. Description
inspection with preventive maintenance. All parts are included which 3451 893A Maintenance kit Dialog
are recommended for exchange during preventive maintenance.
MT-MD-DE08C M.KAY
5.1 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/Dialog Advanced Serial No.: ............................................ Art. No.: ............................................
Automatic Blood Pressure Measurement ABPM Serial No.: ............................................
Manufacturer B. Braun Medizintechnologie GmbH

User Anschrift: ................................................................................................................
.................................................................................................................................
.................................................................................................................................
.................................................................................................................................
Environmental Conditions The environmental conditions must be from 15 °C to 25 °C, the relative
humidity must be between 20 % and 85 % (normal room condition).
- tight seat of all connectors OK

1. Visual Inspection - no damages which could affect the function or the safety (incl. OK
tubing and cuff)
2. Limits of Error of the Pressure Admit a static pressure to the unit. The permissable tolerance is ± 5 mmHg for
each measurement.
Indication
Pressure Measurement Value Deviation
[mmHg] Dialog Reference [mmHg]
300
250
200
150
100
50
0
3. Air Leakage The pressure drop must not exceed 18 mmHg.

(including tubing and cuff)
Initial Pressure Final Pressure Air Leakage

[mmHg] [mmHg] [mmHg/min]
4. Rapid Exhaust Time for pressure reduction from >260 mmHg to <15 mmHg max. 10 s ........ s
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 performed Name of Service Technician:

correctly.
..................................................................................
..................................................................................
Date / Signature
MT-MD-DE08C M.KAY
Execution Procedure for Measurement Inspection

• Reference pressure instrument (accuracy ≤ 0.8
mmHg)
• Measurement chamber with 500 ml volume (rigid
metal vessel, e.g. art. no. 770 3090)
• Syringe 50 ml (for pressure build-up)
• Stopcock system (e.g. art. no. 770 2035)
• Luer-lock connector (e.g. art. no. 3477 0739)
• Connection tubing
To Point 2: Limits of Error of the Pressure Indication Measurement according to DIN EN 1060-1:1995 and
DIN EN 1060-3:1997.
Reference Instrument
Referenzmeßgerät 1. Connect all components acc. to figure (stopcock
system acc. fig.).
Measurement Chamber
2. Switch on Dialog in TSM service program.
Meßkammer 3. Select in TSM Manual Test and Calibration, TTL
Dialog ABPM Manual Test and Calibration and then ABPM
500 ml
Maintenance.
4. Press P Test button.
Wait until a pressure build-up of approx. 170 mmHg
(start of pressure retention phase).
Pressure Tube 5. Open/close valve 4 and set a test pressure of 300
Druckschlauch
mmHg with the syringe (in ABPM Maintenance
1 2 3 4 menu) respectively. Enter displayed value from
50 ml
Stopcock System 50 ml Syringe reference instrument in table.

Mehrwegehahnsystem 50 ml Spritze
6. Decrease pressure in increments of 50 mmHg and
Fig.: Inspection Set-up for Compliance of Error Limits of the enter values in table.
Measurement Display 7. Enter deviations in table.
To Point 3: Air Leakage

Cuff 1. Set-up and connect ABPM and cuff according to
Dialog ABPM Manschette
figure.
2. Press Test 4 button.
A test pressure of approx. 300 mmHg is
automatically built up (test duration approx. 4
Measurement minutes, i.e. 1 minute stabilisation, 3 minutes test).
Chamber
Pressure Tube Meßkammer
Druckschlauch 3. Enter values in table after test is expired.
The values are displayed after the time has
Fig.: Inspection Set-Up for Inspection of Air Leakage elapsed:
The Initial Pressure, Final Pressure and Leakage are
displayed in the ABPM Maintenance menu point 4.
Pressure drop (leakage) must not be > 18 mmHg (6
mmHg/min).
MT-MD-DE08C M.KAY
To Point 4: Rapid Exhaust
Dialog ABPM 1. Press P Test button.

Wait until a pressure build-up of approx. 170
mmHg (start of pressure retention phase).
2. Increase slowly pressure to > 300 mmHg with the
syringe until valve opens for rapid exhaust.
3. The valve for rapid exhaust must open between
Pressure Tube 300 and 330 mmHg. The indicated time for the
Druckschlauch pressure drop must not be exceeded.
1
50 ml
Stopcock System 50 ml Syringe

Mehrwegehahnsystem 50 ml Spritze
MT-MD-DE08C M.KAY

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Dialog/Dialog Advanced

5. Technical Safety Inspection and Preventive Maintenance 4/2002 5-1

Copyright This technical documentation contains confidential

Service Only competent individuals that are trained in the repair,

ESD Recommendations Pay attention to ESD requirements, because electronic

Calibration Only perform a calibration after the Dialog/Dialog Advanced

Check List Note: Only calibrated measurement equipment must be used!

S M S = Technical Safety Inspection Points; M = Preventive Maintenance Points No Yes OK

M Disinfection/decalcification was performed   

S M S = Technical Safety Inspection Points; M = Preventive Maintenance Points No Yes OK

- 100 = .................. [mmHg] 

3. Function Inspection (Document Measurement Values)

S M T = Technical Safety Inspection Points; P = Preventive Maintenance Points No Yes OK

S 3.9 Mains Failure Interruption: - Check function and alarm tone 

4. Electrical Safety Check According to EN 60601-1/IEC 601-1

- Rinsing bridge (dialyser inlet and outlet) .......................... [Ω] 

Staff Call (Option) - Rear door socket .......................... [Ω] 

S M T = Technical Safety Inspection Points; P = Preventive Maintenance Points No Yes OK

5. Setting into Service According to Operating Instructions

S 5.2 Temperature - Comparison measurement at 37 oC (-1.5; +0.5) ......................... [oC] 

S 5.3 Conductivity - Comparison measurement at dialyser coupling,

S 5.5 Ultrafiltration - Comparison measurement at UF rate 500 (±15) ...................... [ml/h] 

b Maintenance Kit Dialog

5.1 Inspection Protocol for Automatic Blood

Automatic Blood Pressure Measurement ABPM Serial No.: ............................................

Manufacturer B. Braun Medizintechnologie GmbH

- tight seat of all connectors OK 

3. Air Leakage The pressure drop must not exceed 18 mmHg.

Initial Pressure Final Pressure Air Leakage

The measurement inspection was performed Name of Service Technician:

Execution Procedure for Measurement Inspection

Stopcock System 50 ml Syringe reference instrument in table.

To Point 3: Air Leakage

To Point 4: Rapid Exhaust

Dialog ABPM 1. Press P Test button.

Stopcock System 50 ml Syringe

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M Disinfection/decalcification was performed

- 100 = .................. [mmHg]

S 3.9 Mains Failure Interruption: - Check function and alarm tone

- Rinsing bridge (dialyser inlet and outlet) .......................... [Ω]

Staff Call (Option) - Rear door socket .......................... [Ω]

S 5.2 Temperature - Comparison measurement at 37 oC (-1.5; +0.5) ......................... [oC]

S 5.5 Ultrafiltration - Comparison measurement at UF rate 500 (±15) ...................... [ml/h]

- tight seat of all connectors OK