1.

Installation and Commissioning

Copyright

1/2003

1-1

This technical documentation remains with all rights the

property of B. Braun Medizintechnologie GmbH.
B. Braun Medizintechnologie GmbH

October 2003

Servicing

Only trained personnel must commission and service the

Dialog+!
Servicing must only be perfomed 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!

Electrical Shock Hazard

To prevent electrical shock hazard - Switch off the Dialog+

and disconnect unit from mains before opening the unit!
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!
If necessary open the machine for servicing!

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!

Prevent Shorts during Exchange of

Boards/Valves/Pumps (+24 VL)

Prevent shorts during the exchange of boards, valves and

pumps: Remove the fuse F600 10 AM (+24 VL) from the
switch mode power supply, because the decrease of the +24
VL is very slow.

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!

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.

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.

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B. Braun Medizintechnologie GmbH

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ESD Requirements

Pay attention to ESD requirements, because electronic

components are sensitive to electrostatic discharges!

Calibration

Only perform a calibration after the Dialog+ has reached

working temperature!

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!

Operating Manual

Please pay attention to the information in the operating

manual!

Check Machine

Check completeness of machine and transport damages after

unpacking!

Commissioning

Do not start machine if a safe operation is not guaranteed!

Electrical Installation

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 equalization must be in accordance with
national requirements (e.g. IEC publications)

Mains Voltage Supply

The mains voltage supply must correspond with the mains

voltage on the unit type plate!

Ambient Temperature

Before the Dialog+ is switched on the machine must have

room temperature (see operating manual, chapter 9)!

Water Installation

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)!

Water Installation

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).

Water Quality

Only water of the highest quality should be applied. Please

consider the following, especially for bicarbonate dialysis:
Inlet water shall be free of Mg++ and Ca++.

Central Hot Cleaning System

If the machine is connected to a central hot cleaning system a

high temperature tubing must be used for the water inlet.

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B. Braun Medizintechnologie GmbH

1. Installation and Commissioning

Table of Contents
1.1

Commissioning Record

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Commissioning Record

For Dialog+

The commissioning (setting into service) according to the specified check list, with reference
to the service manual and operating manual must be performed and documented before the
machine is handed over to the user.

Typ.: .................................................... Nr.: .......................................................................

Year of Purchase: .............................. User: ....................................................................
................................................................................................................................................
Operating Hours: ........................... h Inventory No.: .....................................................
SW Version: ........................................

Manufacturer:

B. Braun Medizintechnologie GmbH

Schwarzenberger Weg 73-79, 34212 Melsungen, Germany

Check List
OK
1.

Visual Inspection

1.1

Machine: clean/complete; no damages/moisture influences; unit rollers are moveable; machine record book present; type plate and warning if
present (HDF bag) legible

1.2

Check tight seat of mains supply (power supply line, strain relief) and connectors

2.

Install Machine

2.1
2.2
2.3
2.4
2.5
2.5.1
2.6

Connect water inlet/outlet (metal tubing conntector: water inlet; plastic tubing connector: water outlet). Fasten tubing for water inlet with tubing
clamp.
Assemble holder for disinfectant (if present)
Assemble dialyser holder (if present)
Connect central supply for concentrate (if option present)
Assemble arm of HDF bag (if option present)
Fasten bag holder with Loctite 242
Assemble DF filter/HDF filter (if option present)

3.

Function Inspection (Document Measurement Values)

!
!
!
!
!
!
!

Pay attention to the filling procedure of the machine to prevent dry run of the heater!
(To point 3.3: Screw manometer in pressure reducer prior to the switch-on of the machine.)
3.1

Switch on machine:

3.1.1

- Fill approx. 10 min in program [Disinfection/Rinsing] and then switch to [Heamodialysis]

- Select [bicarbonate mode] and connect the appropriate concentrate/bicarbonate

3.2

Power Fail Function:

- Check function, duration of a constant audible alarm > 1 minute

(Activate buzzer in power supply, i.e. disconnect mains plug)

3.3

Check water pressure at pressure reducer valve DMV

- if necessary set (1.3 bar, with switched on DF flow)

3.4

TFT Monitor:

- Function/images/alarm signals/touch function

3.5

Blood Pump:

- Alarm cover switch, one-way bearing

3.6

Single Needle Pump (Option):

- Alarm cover switch, one-way bearing

3.7
3.7.1

Venous Tubing Clamp:

- Function and moveability

- Gap 1.4 (+0.1 mm)

!
!

3.8
3.8.1

Arterial Tubing Clamp (Option):

- Function and moveability

- Gap 1.4 (+0.1 mm)

!
!

3.9

Arterial Pressure PA:

- Comparison measurement at:

(permissible tolerance 10 [mmHg])

3.10

Inlet Pressure PBE:

- Comparison measurement at:

(permissible tolerance 10 [mmHg])

3.11

Inlet Pressure PBS (Option):

- Comparison measurement at:

(permissible tolerance 10 [mmHg])

3.12

Venous Pressure PV:

- Comparison measurement at:

(permissible tolerance 10 [mmHg])

3.13
3.13.1

Balance System HDF Bag (Option)

Load cell comparison measurement (with reference weight) at:
(permissible tolerance 50 g)

3.13.2

3.14

Staff Call (Option)

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0 =................................. [mmHg]

0 =................................. [mmHg]

+ 400 =................................. [mmHg]

0 =................................. [mmHg]

+ 400 =................................. [mmHg]

0 =................................. [mmHg]

+ 400 =................................. [mmHg]

+ ____.______ g =.......................................... [g]

Difference between Reference/Actual Value =____________________ [g]

Load cell comparison measurement (without reference weight) at:

(permissible tolerance 50 g)

- 400 =................................. [mmHg]

0 g =.......................................... [g]
Difference between Set/Actual Value =____________________ [g]

- Function or contact continuity passed

!
!

B. Braun Medizintechnologie GmbH

1. Installation and Commissioning

1/2003

1-5
OK

3.15

BIC Cartridge Holder (Option):

- Option not present

- Check reed sensor (BKUS) in BIC cartridge holder
(TSM, LLC Manual Test, 1.23 BIC Cartridge Valves and Coupling Detectors)

!
!

3.16

DF filter/HDF filter (Options)

- Options not present

- Visual inspection with respect to tightness

3.17

Switch to TSM service program:

- Perform system configuration (Default Table)

- Enter BICLF ratio and ENDLF ratio (LLC Manual Calibration, Calibration 2.10 BICLF Ratio and
ENDLF Ratio)
- Set disinfectant
- Update the production report

!
!
!
!

4.

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

4.1

Measure Mains Voltage

4.2

Protective Earth Conductor Resistance < 0.2 []:

(Machine incl. power supply cord. Move the power supply cord during the check. Thus possible loose connections can be detected. Data lines must
not be connected during the check of the protective earth conductor resistance.)
- Potential equalization bolt
......................................... []
- Screw connection heater body
......................................... []
- Rinsing bridge (dialyser inlet and outlet)
......................................... []
Interior:
- Rear door (top left corner)
......................................... []
- Frame (rear)
......................................... []
- Housing cover (top left)
......................................... []
TFT Monitor:
- One of the screws in the housing frame of the TFT monitor
......................................... []
Staff Call (Option):
- Rear door socket
......................................... []

4.3

........................................ [V~]

!
!
!
!
!
!
!
!

Earth Leakage Current (All water connections and data lines must be connceted during the check of the earth leakage current.):
0.5 [mA]

4.4

!
!

- During heat-up phase

....................................... [mA]

Patient Leakage Current (All water connections and data lines must be connceted during the check of the patient leakage current.)
< 0.01 [mA] DC:

- Under normal conditions (conductivity at 14 mS/cm)

....................................... [mA]

< 0.1 [mA] AC:

- Under normal conditions (conductivity at 14 mS/cm)

....................................... [mA]

5.

Setting into Service According to Operating Manual

5.1

Applied Accesories/Disposables:

- Applied line system:

Name: ............................................................................................................................................................................
- Applied heparin syringe (listed in syringe table: Treatment Support, System Configuration, Heparin Parameters):
Name: ............................................................................................................................................................................
!

5.2

Switch on machine:

- Selftest passed

5.3

Temperature:

- Comparison measurement 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

Ultrafiltration:

- Comparison measurement > 30 min at UF rate 500 ml/h (15)

5.6

Safety Air Detector (SAD):

- Test alarm function passed

5.7

Disinfection:

- Perform chemical disinfection/decalcification

Applied Measurement Equipment:

................................. [ml/h]

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

Temperature: ................................................................................................ * ID/Serial No.: ..............................
Pressure: ........................................................................................................ * ID/Serial No.: ..............................
Electrical Safety Check: ............................................................................. * ID/Serial No.: ..............................
Reference Weight: ...................................................................................... * ID/Serial No.: ..............................
Pressure Manometer: ................................................................................. * ID/Serial No.: ..............................
Device for UF Measurement: .................................................................... * ID/Serial No.: ..............................
* If applicable, please enter the type and identification number of the equipment used.

The commissioning was performed and the machine

was hand over to the user

Name Service Technician:

Name of Company:

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

User: ...............................................................
Date / Signature

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B. Braun Medizintechnologie GmbH