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SW9.1x Instruction of Use PDF

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0% found this document useful (0 votes)

2K views302 pages

SW9.1x Instruction of Use PDF

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Al Imran

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+

Dialog Dialysis Machine

Instructions for Use SW 9.1x

CE marking according to directive 93/42/EEC
Technical alterations reserved
B. Braun Avitum AG

34209 Melsungen, Germany

Tel +49 (56 61) 71-3716
Fax +49 (56 61) 75-3716

IFU 38910273EN / Rev. 2.11.00 / December 2011 www.bbraun.com

Dialog+ Overview

1 Safe handling 1

2 Product description 2

3 Installation and commissioning 3

4 Preparing for haemodialysis 4

5 Initiating haemodialysis 5

6 End of haemodialysis therapy 6

7 Disinfection 7

8 HDF-online/HF-online 8

9 Single-needle procedure 9

10 Use of options 10

11 Configuration 11

12 Maintenance and cleaning 12

13 Alarms and remedial action 13

14 Accessories 14

15 Technical data 15

16 Appendix 16
Table of contents Dialog+

II IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Table of contents

Table of contents

1 Safe handling ....................................................................................... 1-3

1.1 About these instructions for use ........................................................ 1-3
1.1.1 Validity .........................................................................................................1-3
1.1.2 Target group ...............................................................................................1-3
1.1.3 Warnings, notices and symbols in these instructions for use......1-4
1.1.4 Abbreviations .............................................................................................1-5
1.2 Intended use and indication................................................................ 1-5
1.3 Contraindication................................................................................... 1-6
1.4 Side effects ........................................................................................... 1-6
1.5 Special hazards and precautions......................................................... 1-6
1.5.1 Special patient conditions......................................................................1-6
1.5.2 Electrical hazards ......................................................................................1-7
1.5.3 Electromagnetic interactions ................................................................1-7
1.5.4 Maintenance and filter change.............................................................1-8
1.6 Information for the operator .............................................................. 1-8
1.6.1 Training by manufacturer prior to commissioning..........................1-8
1.6.2 Requirements on the user ......................................................................1-8
1.6.3 Conformity ..................................................................................................1-9
1.6.4 Manufacturer’s responsibility................................................................1-9
1.6.5 Technical changes.................................................................................. 1-10
1.7 Disposal and taking back of old dialysis machines......................... 1-10

2 Product description ............................................................................. 2-3

2.1 Basic models.......................................................................................... 2-3
2.1.1 Dialog+ single-pump machine ...............................................................2-6
2.1.2 Dialog+ double-pump machine .............................................................2-7
2.1.3 Dialog+ HDF-online...................................................................................2-8
2.2 Symbols on the dialysis machine ........................................................ 2-9
2.3 Control elements and information on the monitor ........................ 2-10
2.4 Overview of all icons.......................................................................... 2-12
2.5 Entering numerical values ................................................................. 2-19
2.6 Therapy types...................................................................................... 2-22
2.6.1 Haemodialysis (HD) ............................................................................... 2-22
2.6.2 Isolated ultrafiltration (ISO UF) ......................................................... 2-22
2.6.3 Haemofiltration (HF/HF-online)......................................................... 2-23
2.6.4 Haemodiafiltration (HDF/HDF-online) ............................................. 2-23
2.7 Methods of treatment ....................................................................... 2-24
2.7.1 Double-needle procedure .................................................................... 2-24
2.7.2 Single-needle procedure ...................................................................... 2-24
2.7.3 Single-needle cross-over procedure ................................................. 2-24
2.7.4 Single-needle valve procedure........................................................... 2-26

IFU 38910273EN / Rev. 2.11.00 / December 2011 III

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2.8 Effectiveness of dialysis (Kt/V)......................................................... 2-27

2.9 Using the timer/stop watch .............................................................. 2-28

3 Installation and commissioning.......................................................... 3-3

3.1 Scope of supply .................................................................................... 3-3
3.2 Storage .................................................................................................. 3-3
3.2.1 Storage in originally packed condition...............................................3-3
3.2.2 Interim storage of devices ready for operation................................3-3
3.2.3 Decommissioning ......................................................................................3-3
3.3 Transportation ...................................................................................... 3-4
3.3.1 Wheeling .....................................................................................................3-4
3.3.2 Carrying .......................................................................................................3-5
3.4 Installation site..................................................................................... 3-6
3.4.1 Electrical connection ...............................................................................3-6
3.4.2 Protection against water damage........................................................3-6
3.4.3 Potentially explosive areas.....................................................................3-6
3.5 Water supply......................................................................................... 3-7
3.5.1 Quality of water and dialysate..............................................................3-7
3.5.2 Disposal of used fluids.............................................................................3-7
3.6 Initial commissioning ........................................................................... 3-8
3.7 Setting date and time.......................................................................... 3-8
3.8 Switching on and off ........................................................................... 3-9

4 Preparing for haemodialysis................................................................ 4-3

4.1 Calling up haemodialysis ..................................................................... 4-4
4.2 Automatic test...................................................................................... 4-4
4.2.1 Operation during automatic test..........................................................4-5
4.2.2 Terminating the automatic test sequence.........................................4-6
4.2.3 Completion of automatic test sequence ............................................4-6
4.3 Reduction of warning sounds during Preparation ............................ 4-6
4.4 Connecting the concentrate ............................................................... 4-8
4.5 Setting the rinsing parameters........................................................... 4-9
4.6 Inserting and rinsing the tube system ............................................. 4-11
4.6.1 Inserting the tube system.................................................................... 4-11
4.6.2 Rinsing and testing the tube system................................................ 4-14
4.6.3 Level regulation (if present)................................................................ 4-14
4.7 Preparing the heparin pump ............................................................. 4-16
4.7.1 Inserting the heparin syringe.............................................................. 4-16
4.7.2 Venting the heparin line ...................................................................... 4-17
4.8 Setting the treatment parameters ................................................... 4-18
4.8.1 Setting the dialysate parameters ...................................................... 4-19
4.8.2 Monitoring the dialysate ..................................................................... 4-21
4.8.3 Setting the ultrafiltration parameters ............................................. 4-21
4.8.4 Setting the pressure limits .................................................................. 4-24
4.8.5 Setting the heparin parameters......................................................... 4-26

IV IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Table of contents

4.9 Rinsing the dialyser ............................................................................ 4-28

4.10 Stand-by mode ................................................................................... 4-29
4.10.1 Activating the stand-by mode ........................................................... 4-29
4.10.2 Switching off the stand-by mode ..................................................... 4-29
4.11 Power failure in Preparation ............................................................. 4-30
4.12 Changing the bicarbonate cartridge during preparation............... 4-30

5 Initiating haemodialysis ...................................................................... 5-3

5.1 Checking the patient data................................................................... 5-3
5.2 Connecting the patient and starting haemodialysis......................... 5-4
5.2.1 Level regulation (if present)...................................................................5-5
5.3 During haemodialysis ........................................................................... 5-7
5.3.1 Monitoring the blood-side pressure limits ........................................5-7
5.3.2 Treatment at minimum UF rate ............................................................5-9
5.3.3 Heparin bolus .......................................................................................... 5-10
5.3.4 Arterial bolus........................................................................................... 5-10
5.3.5 Graphical representation of treatment parameters (trend)....... 5-12
5.3.6 Interrupting the haemodialysis (bypass) ......................................... 5-15
5.4 Completion of treatment................................................................... 5-15
5.4.1 Terminating treatment ......................................................................... 5-15
5.4.2 Continuing treatment ........................................................................... 5-15

6 End of haemodialysis therapy ............................................................ 6-3

6.1 Reinfusion ............................................................................................. 6-3
6.2 Emptying the dialyser .......................................................................... 6-5
6.3 Emptying the cartridge after dialysis................................................. 6-5
6.4 Overview of the therapy carried out.................................................. 6-6

7 Disinfection .......................................................................................... 7-3

IFU 38910273EN / Rev. 2.11.00 / December 2011 V

Table of contents Dialog+

7.7.3 Thermal disinfection with hot permeate from central

water supply ............................................................................................ 7-14
7.7.4 Rinsing the permeate inlet.................................................................. 7-15
7.8 Checking for disinfectant residues................................................... 7-16
7.9 Decalcification.................................................................................... 7-17
7.9.1 Automatic descaling ............................................................................. 7-17
7.10 Terminating disinfection ................................................................... 7-19
7.11 Disposal of old dialysis appliance ..................................................... 7-20

8 HDF-online/HF-online ......................................................................... 8-3

8.1 Preparing for haemodiafiltration/haemofiltration ........................... 8-4
8.1.1 Calling up haemodiafiltration/haemofiltration................................8-4
8.1.2 Connecting the concentrate ..................................................................8-4
8.1.3 Entering the substitution parameters .................................................8-5
8.1.4 Inserting the tube system.......................................................................8-7
8.1.5 Filling and rinsing the tube system with substitution
solution from the online system...........................................................8-7
8.1.6 Inspecting the tube system................................................................. 8-10
8.2 Preparing for standard haemodialysis with online fluid ................ 8-10
8.3 Carry out haemodiafiltration/haemofiltration................................ 8-11
8.3.1 Connect patient and start haemodiafiltration/haemofiltration8-11
8.3.2 During haemodiafiltration/haemofiltration ................................... 8-13
8.4 Finish haemodiafiltration/haemofiltration...................................... 8-15
8.4.1 Reinfusion with substitution solution ............................................. 8-15
8.4.2 Emptying the dialyser ........................................................................... 8-17
8.5 Disinfection......................................................................................... 8-17
8.5.1 Regular disinfection .............................................................................. 8-17
8.5.2 Displaying the online filter data........................................................ 8-17
8.5.3 Changing the online filter ................................................................... 8-18
8.5.4 Sampling of substitution fluid ........................................................... 8-21

9 Single-needle procedure ..................................................................... 9-3

9.1 Single-needle cross-over (SN-CO) ..................................................... 9-3
9.1.1 Preparing the therapy..............................................................................9-3
9.1.2 Level regulation (if present)...................................................................9-5
9.1.3 Running the therapy ................................................................................9-7
9.1.4 Ending the therapy ...................................................................................9-8
9.2 Single-needle valve (SN-valve) .......................................................... 9-9
9.2.1 Preparing the therapy..............................................................................9-9
9.2.2 Running the therapy ............................................................................. 9-11
9.2.3 Ending the therapy ................................................................................ 9-12

10 Use of options ....................................................................................10-3

VI IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Table of contents

10.1.4 Showing and graphically displaying measured values ................ 10-8

10.2 bioLogic RR® Comfort - automatic blood pressure stabilisation
with the guideline method ..............................................................10-10
10.2.1 Mode of operation ...............................................................................10-10
10.2.2 Setting of systolic blood pressure lower limit (SLL) and
maximum ultrafiltration rate ...........................................................10-12
10.2.3 Setting of suggested systolic blood pressure lower
limit (SLL) ...............................................................................................10-14
10.2.4 Activating/deactivating bioLogic RR® Comfort...........................10-14
10.2.5 Graphical representation of ultrafiltration and blood pressure
progression.............................................................................................10-15
10.3 Adimea...............................................................................................10-17
10.3.1 Setting the parameters.......................................................................10-17
10.3.2 Graphic representation during therapy .........................................10-18
10.3.3 Target warning......................................................................................10-20
10.3.4 Extended functionality when using the patient
therapy card...........................................................................................10-21
10.3.5 Kt/V table................................................................................................10-23
10.4 Bicarbonate cartridge holder ..........................................................10-24
10.4.1 Inserting the cartridge........................................................................10-24
10.4.2 Changing the cartridge during dialysis..........................................10-25
10.4.3 Emptying the cartridge after dialysis .............................................10-28
10.5 Central concentrate supply .............................................................10-28
10.6 Dialysis fluid filter............................................................................10-29
10.6.1 Use and mode of operation...............................................................10-29
10.6.2 Changing dialysis fluid filter.............................................................10-30
10.6.3 Resetting the data ...............................................................................10-33
10.6.4 Disinfection............................................................................................10-34
10.6.5 Sampling of dialysis fluid ..................................................................10-35
10.7 Emergency power supply/battery ...................................................10-37
10.7.1 Charging indicator ...............................................................................10-38
10.7.2 Automatic battery test .......................................................................10-38
10.7.3 End of battery operation....................................................................10-39
10.8 Communication interfaces ..............................................................10-39
10.8.1 BSL (Bed Side Link) ..............................................................................10-39
10.8.2 DialogP+P-computer interface (DCI) ...................................................10-39
10.8.3 Staff call .................................................................................................10-39
10.9 Crit-Line Interface ...........................................................................10-40
10.9.1 Function..................................................................................................10-40
10.9.2 Set-up and connection with the DialogP+P ......................................10-42
10.9.3 Setting.....................................................................................................10-43
10.9.4 Graphical presentation of trends.....................................................10-45
10.9.5 Reading of the data from the patient therapy card...................10-46

11 Configuration ..................................................................................... 11-3

IFU 38910273EN / Rev. 2.11.00 / December 2011 VII

Table of contents Dialog+

11.4.1 Basic principles....................................................................................... 11-9

11.4.2 Setting profile parameters .................................................................. 11-9
11.5 UF profiles.........................................................................................11-11
11.5.1 Select UF profiles .................................................................................11-11
11.5.2 UF profile table .....................................................................................11-13
11.6 Patient therapy card ........................................................................11-18
11.6.1 Erasing data from patient therapy card ........................................11-18
11.6.2 Entering the patient name ................................................................11-19
11.6.3 Reading patient data ..........................................................................11-20
11.6.4 Storing patient data (parameter settings)....................................11-20
11.7 Entering parameters for computing the effectiveness of the
dialysis ...............................................................................................11-21
11.8 Adjusting the monitor brightness...................................................11-26
11.9 Select language of screen text.......................................................11-27
11.10 Edit parameter of trend groups......................................................11-28

12 Maintenance and cleaning................................................................12-3

12.1 External cleaning ............................................................................... 12-3
12.2 Preventive maintenance and technical safety inspection.............. 12-4
12.2.1 Regular preventive maintenance....................................................... 12-4
12.2.2 Technical safety inspection................................................................. 12-5
12.2.3 Accessories, disposable items and expendable parts................... 12-5
12.3 Technical service and warranty ........................................................ 12-5
12.3.1 Warranty................................................................................................... 12-5
12.4 Disposal of old dialysis machines...................................................... 12-5

13 Alarms and remedial action..............................................................13-3

13.1 Display and reset alarms.................................................................... 13-3
13.2 Alarms and consequences.................................................................. 13-5
13.2.1 Dialysis alarms ........................................................................................ 13-5
13.2.2 ABPM alarms.........................................................................................13-13
13.2.3 Crit-Line alarms....................................................................................13-15
13.2.4 Level regulation alarms ......................................................................13-16
13.2.5 Adimea alarms ......................................................................................13-17
13.2.6 bioLogic RR® Comfort alarms...........................................................13-18
13.2.7 Online alarms ........................................................................................13-19
13.3 Remedying SAD alarms....................................................................13-21
13.4 Manual blood return........................................................................13-22
13.5 Omission of acoustic signals ...........................................................13-24
13.5.1 Omission of acoustic signals for alarm..........................................13-24
13.5.2 Omission of acoustic signals for advice ........................................13-24

14 Accessories..........................................................................................14-3
14.1 Options ................................................................................................ 14-3

VIII IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Table of contents

14.2 Mechanical accessories...................................................................... 14-4

14.3 Other accessories................................................................................ 14-4

15 Technical data.................................................................................... 15-3

15.1 General technical data....................................................................... 15-3
15.2 Ambient conditions ............................................................................ 15-4
15.3 Recommended safe distances............................................................ 15-5
15.4 Dialysate system ................................................................................. 15-6
15.5 Extracorporeal circulation................................................................. 15-9
15.6 Materials coming into contact with water, dialysate, dialysis
concentrates and/or disinfectants..................................................15-11
15.7 Technical data HDF/HF-online........................................................15-12
15.8 ABPM blood pressure monitoring...................................................15-13
15.9 Technical data of Crit-Line interface ............................................15-14

16 Appendix............................................................................................. 16-3
16.1 Flow diagrams..................................................................................... 16-3
16.1.1 Key to flow diagrams ............................................................................ 16-3
16.1.2 Flow diagram Dialog+............................................................................ 16-5
16.1.3 Flow diagram Dialog+ HDF-online ..................................................... 16-6
16.2 Technical safety inspection and preventive maintenance ............. 16-7

IFU 38910273EN / Rev. 2.11.00 / December 2011 IX

Table of contents Dialog+

X IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Safe handling

Table of contents 1

1 Safe handling ....................................................................................... 1-3

IFU 38910273EN / Rev. 2.11.00 / December 2011 1-1

Safe handling Dialog+

1-2 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Safe handling

1 Safe handling
1
1.1 About these instructions for use

These instructions for use form an integral part of the dialysis machine. They describe
the appropiate and safe use of the dialysis machine.

The dialysis machine must always be used in accordance with the instructions for
use.
Always keep the instructions for use at the dialysis machine for later use.
Pass on the instructions for use to any future user of the dialysis machine.

1.1.1 Validity

Article numbers
These instructions for use apply to Dialog+ dialysis machines with the following article
numbers (REF):
• 710200X
• 710201X
• 710207X
X = Combination of options at the time of delivery.

Software version
These instructions for use apply to software version 9.1x (x = any).

1.1.2 Target group

The target group for these instructions for use is specialist medical staff.
The dialysis machine may only be used by persons instructed for its appropiate
operation.

IFU 38910273EN / Rev. 2.11.00 / December 2011 1-3

Safe handling Dialog+

1.1.3 Warnings, notices and symbols in these instructions for use

1
Warnings in these instructions for use point out particular hazards for users, patients,
third parties and the dialysis machine. They also suggest measures that can be taken
to avoid the respective hazard.
There are three levels of warning notices:

Warning term Meaning

DANGER Imminent danger that can lead to death or serious injury if not
avoided.

WARNING Potentially imminent danger that can lead to death or serious

injury if not avoided.

CAUTION Potentially imminent danger that can lead to minor injuries or

damage to equipment if not avoided.

The warning notices are highlighted in the following manner (see below example for a
CAUTION warning):

Here, the type and source of the danger are listed and possible consequences if
measures are not followed!
CAUTION  This is the list of measures to prevent the hazard.

This is the list of important information, directly or indirectly relating to safety and
the prevention of damage.

This is additional useful information concerning safe procedures, background

information and recommendations.

 This symbol marks the instructions for action.

1-4 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Safe handling

1.1.4 Abbreviations
1
ABPM Automatic blood pressure monitoring
BPA Arterial blood pump
BPV Venous blood pump
BSL Bed Side Link
CO Cross-over
HD Haemodialysis
HDF Haemodiafiltration
HF Haemofiltration
HP Heparin pump
ISO UF Isolated ultrafiltration
PA Arterial pressure
PBE Blood-side entry pressure at dialysis machine
PBS Blood pump control pressure for single-needle procedure
PV Venous pressure
RDV Venous red detector
SAD Safety air detector
SAKA Arterial tube clamp
SAKV Venous tube clamp
SN Single-needle
SN-CO Single-needle cross-over
TMP Trans membrane pressure
TSM Technical support and maintenance mode
UF Ultrafiltration
ZKV Central concentrate supply

1.2 Intended use and indication

The dialysis machine can be used for implementing and monitoring haemodialysis
treatments for patients with acute or chronic kidney failure. The system can be used
for hospital, health centre, limited-care or home dialysis.
Depending on the model, the following types of therapy can be carried out with the
system:
• Haemodialysis (HD)
• Isolated ultrafiltration (ISO UF): Sequential therapy (Bergström)
• Haemodiafiltration (HDF)
• Haemofiltration (HF)

IFU 38910273EN / Rev. 2.11.00 / December 2011 1-5

Safe handling Dialog+

1 1.3 Contraindication

There are no known contraindications for chronic haemodialysis.

The doctor in charge of the treatment is responsible for choosing the suitable therapy,
based on medical and analytical findings and the general health and condition of the
patient.

1.4 Side effects

Hypotonia, nausea, vomiting and cramps are possible side effects.

Oversensitive reactions caused by using the necessary tubing and filter materials have
been observed in only few cases. For this matter, please refer to the product
information provided with the consumables.

1.5 Special hazards and precautions

1.5.1 Special patient conditions

The dialysis system may only be operated on doctor´s instructions if the patient suffers
from one of the following conditions:

• Unstable circulation
• Hypokalemia

Dialysis for patients with a body weight of less than 30 kg requires a wider
safety concept than that applicable to heavier patients.
The special risks concern excessive blood loss, excessive blood flow and a
disproportionately large extracorporeal blood volume compared to the blood
volume of the patient!
 Special precautions are required, e. g. intensified monitoring of the patient.
WARNING
 The dialysis machine must not be employed without qualification and
adjustment of the entire therapy concept to the special conditions of the
patient. Especially, the compatibility of individual consumables with each
other and with the dialysis system must be considered.

1-6 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Safe handling

1.5.2 Electrical hazards

1
The dialysis machine contains life-threatening electrical voltages.

Risk of electric shock and fire.

 Always insert mains plug completely into the mains socket.
 Always pull/push on the plug not on the mains cord to connect or disconnect
the mains plug.
WARNING
 Avoid damage of the mains cord for example by running over it with the
machine.

It must not be used or connected to mains voltage if the housing or the mains cord is
damaged in any way. A damaged dialysis machine must be submitted for repairs or
disposed of.

Interaction with other devices

When using the dialysis machine in combination with other therapeutic devices of
protection class I, a potential equalisation device must be connected, since the leakage
currents from all connected devices are additive and the electrostatic discharge from
the environment to Dialog+ may occur.
Do not connect customary consumer devices to the same power socket as the dialysis
machine or to connect them in parallel.

Use with central-venous catheter

For cardiac application, a higher degree of protection against electric shock is
required. Electric currents can run through supply lines via the dialysis fluid filter, the
dialyser, the catheter, the patient and every conducting object in the vicinity of the
patient. That is why electrical potential equalisation must be provided. As soon as
earth potential equalisation is connected to the machine the patient leakage current
has to be below 10 A, which complies with the limit value for patient leakage current
of type CF. A special potential equalisation cable is available. It can be connected to
the bolt at the rear side of the machine. The ambient conditions of the premises must
be in accordance to the local requirements (see chapter 1.6.4).

1.5.3 Electromagnetic interactions

The dialysis machine has been developed and tested in accordance with the valid
standards for interference suppression and electromagnetic compatibility (EMC).
However, it cannot be guaranteed that no electromagnetic interaction with other
devices will occur (examples: mobile phones, computer tomograph (CT)).

Risk of electrostatic discharge from other devices.

 It is recommended that mobile phones and other devices emitting strong
electromagnetic radiation only be used at a minimum distance, according to
CAUTION
IEC 60601-1-2 (see also chapter 15.3).

IFU 38910273EN / Rev. 2.11.00 / December 2011 1-7

Safe handling Dialog+

1 Placing other therapeutic or diagnostic medical devices on Dialog+ or near by or use

of non-medical devices directly near the Dialog+ can influence electromagnetic
interactions. In this case the user must observe the Dialog+ and all other machines to
assure their correct operation.

1.5.4 Maintenance and filter change

In order to protect patients against cross-contamination, the transducer protectors of

the tube systems to be used are equipped with hydrophobic 0.2-m filters. If, despite
this protective measure, blood enters into the machine-side transducer
protectors/pressure sensors, the dialysis machine may only be used again after
appropriate cleaning and disinfection was carried out by technical service.
Due to the particularly stringent hygienic requirements, we recommend annual
servicing of dialysis machines with dialysis fluid filters and of Dialog+ HDF-online. The
dialysis fluid filters must be changed as specified in the respective instructions for use.

1.6 Information for the operator

1.6.1 Training by manufacturer prior to commissioning

The operator may only use the device after the manufacturer has trained the
responsible staff based on these instructions for use.

1.6.2 Requirements on the user

The dialysis machine may only be used by persons instructed for its appropriate
operation.
The operator must ensure that the instructions for use are read and understood by all
operators of the dialysis machine.
Prior to using the dialysis machine, check for safe functioning and correct condition of
the dialysis machine.

1-8 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Safe handling

1.6.3 Conformity
1
The dialysis machine and the options comply with the requirements of the generally
applicable standards in their respective valid version:
• IEC 60601-1
• IEC 60601-2-30
• DIN EN 1060-1
• DIN EN 1060-3
Additional equipment connected to the analog or digital interfaces of the dialysis
machine must demonstrably meet the relevant IEC specifications (e.g. IEC 60950 for
data processing devices and IEC 60601-1 for electromedical devices). Also, all
configurations must conform with the valid version of System Standard
IEC 60601-1-1.
Persons connecting additional devices to signal input or output components are
performing a system configuration and are, thus, responsible for ensuring that the
valid version of System Standard IEC 60601-1-1 is complied with. In case of queries,
please contact your local specialist dealer or technical service.

In each country the distribution of the machine is carried out provided that the device
is registered and classified according to the local regulations.

1.6.4 Manufacturer’s responsibility

The manufacturer, assembler, installer or implementer shall only be responsible for the
effects on the safety, reliability and performance of the device, if
• the assembly, expansion, readjustments, changes or repairs were carried out by a
person authorised by him and
• if the electrical installation of the affected room comply with the valid national
requirements on the equipment of medical treatment rooms
(i. e. VDE 0100 part 710 and/or IEC60364-7-710).
The device may only be operated if the manufacturer or an authorised person acting
on behalf of the manufacturer
• has carried out a functional check on site (initial commissioning),
• if the persons appointed by the operator to use the device have been trained in the
correct handling, use and operation of the medical product with the aid of the
instructions for use, enclosed information and maintenance information and
• if the quality of the water used with the device corresponds to the relevant
standards.

IFU 38910273EN / Rev. 2.11.00 / December 2011 1-9

Safe handling Dialog+

1.6.5 Technical changes

1
We reserve the right to change our products in line with further technical
developments.

1.7 Disposal and taking back of old dialysis machines

Dialysis machines may be returned to the manufacturer for disposal in accordance

with the applicable disposal guidelines (EC directive 2002/96).

The company B. Braun Avitum AG guarantees the taking back of old B. Braun dialysis
machines.
The dialysis machine has to be disinfected according to regulations before disposal.

1-10 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Product description

Table of contents

2
2 Product description ............................................................................. 2-3
2.1 Basic models.......................................................................................... 2-3
2.1.1 Dialog+ single-pump machine ...............................................................2-6
2.1.2 Dialog+ double-pump machine .............................................................2-7
2.1.3 Dialog+ HDF-online...................................................................................2-8
2.2 Symbols on the dialysis machine ........................................................ 2-9
2.3 Control elements and information on the monitor ........................ 2-10
2.4 Overview of all icons.......................................................................... 2-12
2.5 Entering numerical values ................................................................. 2-19
2.6 Therapy types...................................................................................... 2-22
2.6.1 Haemodialysis (HD) ............................................................................... 2-22
2.6.2 Isolated ultrafiltration (ISO UF) ......................................................... 2-22
2.6.3 Haemofiltration (HF/HF-online)......................................................... 2-23
2.6.4 Haemodiafiltration (HDF/HDF-online) ............................................. 2-23
2.7 Methods of treatment ....................................................................... 2-24
2.7.1 Double-needle procedure .................................................................... 2-24
2.7.2 Single-needle procedure ...................................................................... 2-24
2.7.3 Single-needle cross-over procedure ................................................. 2-24
2.7.4 Single-needle valve procedure........................................................... 2-26
2.8 Effectiveness of dialysis (Kt/V)......................................................... 2-27
2.9 Using the timer/stop watch............................................................... 2-28

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-1

Product description Dialog+

2-2 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Product description

2 Product description

2.1 Basic models

2
The basic model Dialog+ HDF-online is shown below. The legend highlights the
components not installed in all basic models or that are available as an option.

Front view
Legend
1 Venous pressure sensor
connection (blue)
2 Arterial pressure sensor
connection (red)
3 Heparin pump
4 Pressure sensor connection for
regulating the venous blood
pump in single-needle cross-
over operating mode (white)
5 Syringe stop
6 Pressure sensor connection for
arterial inlet pressure to dialyser
(red)
7 Blood pump (one or two blood
pumps depending on basic
model)
8 Rinsing chambers for
concentrate rods
9 Connection for central
concentrate supply (option)
10 Connection for the supply and
discharge of substitution
solution (only for Dialog+ HDF-
online)
11 Arterial tube clamp (for Dialog+
single-pump machine: only
present with option ”SN-valve”)
12 Lever for manual opening of the
venous tube clamp
13 Venous tube clamp
14 Safety air detector (SAD) and red
sensor
15 Fixings for the chamber(s) of the
SN blood tube system
16 Fixings for blood tube system

Fig. 2-1 Basic models, front view

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-3

Product description Dialog+

Side views
Legend
2 1 Mains switch
2 Card reader
3 Connections for dialyser
tubes and rinsing bridge
4 Connection for
disinfectant
5 Caster brake
6 Connection for central
concentrate supply
(option)
7 Bicarbonate cartridge
holder (standard for
Dialog+ HDF-online,
optional for Dialog+ single-
pump machine and
double-pump machine)
8 Storage tray (box)
9 Infusion pole (in some
models, pole may not be
adjustable)

Fig. 2-2 Basic models, side views

2-4 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Product description

Rear view
Legend
1 Type plate
2 Fixture for disinfectant container 2
3 Water inlet
4 Dialysate outlet
5 Mains cord
6 Connection for electrical ground
7 Crank for manual blood return
8 Alternative position of mains
switch

3 Water inlet
4 Dialysate outlet

Fig. 2-3 Basic models, rear view

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-5

Product description Dialog+

2.1.1 Dialog+ single-pump machine

The Dialog+ single-pump dialysis machine is suitable for hospitals, health centres,
limited-care and home dialysis. It offers the following features as standard:
2 • Colour screen and on-screen operation (colour touch screen)
• Acetate/bicarbonate operation
• Volumetric ultrafiltration device
• Heparin syringe pump
• Fixed or freely selectable profile controls for dialysate composition, temperature
and flow rate, for heparin supply and for ultrafiltration
• Heat exchanger
The following features are available as additional options:
• Automatic blood pressure monitoring (ABPM)
• bioLogic RR® Comfort (Automatic blood pressure stabilisation, only in combination
with ABPM)
• Bicarbonate cartridge holder
• Central concentrate supply (ZKV)
• Dialysis fluid filter
• Emergency power supply
• Data interface (also available for other use):
– Dialog+-computer interface
– Staff call
– BSL (Bed Side Link): Card reader and interface to Nexadia® data management
system
• SN-valve with additional tube clamp
• Rollers 7 x 10 mm
• Adimea
• Crit-Line Interface
• Card reader

Therapy types
The Dialog+ dialysis machine with a single blood pump can be used for the following
therapy procedures:
• Haemodialysis (HD)
• Isolated ultrafiltration (ISO UF)

Methods of treatment
The Dialog+ dialysis machine with a single blood pump can be used for the following
therapy methods:
• Double-needle procedure
• Single-needle valve procedure

2-6 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Product description

2.1.2 Dialog+ double-pump machine

The Dialog+ double-pump dialysis machine is suitable for hospital, health centre,
limited-care and home dialysis and offers the following features as standard:
• Colour screen and on-screen operation (colour touch screen)
2
• Double-pump single-needle equipment
• Acetate/bicarbonate operation
• Volumetric ultrafiltration device
• Heparin syringe pump
• Fixed or freely selectable profile controls for dialysate composition, temperature
and flow rate, for heparin supply and for ultrafiltration
• Heat exchanger
The following features are available as additional options:
• Automatic blood pressure monitoring (ABPM)
• bioLogic RR® Comfort (Automatic blood pressure stabilisation, only in combination
with ABPM)
• Bicarbonate cartridge holder
• Central concentrate supply (ZKV)
• Dialysais fluid filter
• Emergency power supply
• Data interface (also available for other use):
– Dialog+-computer interface
– Staff call
– BSL (Bed Side Link): Card reader and interface to Nexadia® data management
system
• Rollers 7 x 10 mm
• Adimea
• Crit-Line Interface
• Card reader

Therapy types
The Dialog+ double-pump dialysis machine can be used for the following therapy
types:
• Haemodialysis (HD)
• Isolated ultrafiltration (ISO UF)

Methods of treatment
The Dialog+ double-pump dialysis machine can be used for the following therapy
methods:
• Double-needle procedure
• Single-needle cross-over procedure
• Single-needle procedure

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-7

Product description Dialog+

2.1.3 Dialog+ HDF-online

The Dialog+ HDF-online dialysis machine is suitable for hospital, health centre,
2 limited-care and home dialysis and offers the following features as standard:
• Colour screen and on-screen operation (colour touch screen)
• Double-pump single-needle equipment
• Acetate/bicarbonate operation
• Volumetric ultrafiltration device
• Heparin needle pump
• Fixed or freely selectable profile controls for dialysate composition, temperature
and flow rate, for heparin supply and for ultrafiltration
• Online production of ultra-clean dialysate for haemodialysis with two-stage dialysis
fluid filter system to ensure the cleanness of the substitution solution
• Online production of substitution solutions free from bacteria and pyrogenes as
used for haemofiltration and haemodiafiltration
• Option of adding substitution solutions by pre- or post-dilution
• Bicarbonate cartridge holder
• Heat exchanger
The following features are available as additional options:
• Automatic blood pressure monitoring (ABPM)
• bioLogic RR® Comfort (Automatic blood pressure stabilisation, only in combination
with ABPM)
• Central concentrate supply (ZKV)
• Emergency power supply
• Data interface (also available for other use):
– Dialog+-computer interface
– Staff call
– BSL (Bed Side Link): Card reader and interface to Nexadia® data management
system
• Rollers 7 x 10 mm
• Adimea
• Crit-Line Interface
• Card reader

Therapy types
The Dialog+ HDF-online dialysis machine can be used for the following therapy types:
• Haemodialysis (HD)
• Isolated ultrafiltration (ISO UF)
• Haemofiltration (HF-online)
• Haemodiafiltration (HDF-online)

Methods of treatment
The Dialog+ HDF-online dialysis machine can be used for the following therapy
methods:
• Double-needle procedure
• Single-needle cross-over procedure; only possible with therapy types HD and ISO UF
• Single-needle procedure

2-8 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Product description

2.2 Symbols on the dialysis machine

Observe instructions for use

2
Observe safety information

Type B applied part

Classification acc. to DIN EN 60601-1/ IEC 601-1

Type BF applied part

Classification acc. to DIN EN 60601-1/ IEC 601-1

Electrical ground

Dialysis machine OFF

Dialysis machine ON

Alternating current

Schematic illustration on safety air detector (SAD) and air detector of the
substitution line showing the correct way of installing the tube

Connection for optional staff call device

Connection for optional automatic blood pressure monitoring (ABPM)

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-9

Product description Dialog+

2.3 Control elements and information on the monitor

2 Signal lamps
Signal lamps on the left and right of the monitor light up in three different colours to
indicate the conditions "Operation", "Fault" and "Alarm".

Legend
1 Signal lamps:
Green = operation
Yellow = warning/note
Red = alarm
2 Buttons on the monitor

Fig. 2-4 Monitor

Buttons on the monitor

Even with the screen switched off (e.g. during cleaning), the basic functions of the
dialysis machine can be controlled via the buttons on the monitor.
The “+” and “-“ buttons (button 2 and 4) automatically count up or down by keeping
the button pushed.

Legend
1 Battery symbol (display
only): battery charging
2 Reduce blood pump speed
3 Switch on/switch off blood
pump
4 Increase blood pump speed
5 Confirm alarm (when button
is illuminated); switches of
the alarm buzzer
6 Enter button: Confirm
entered data and reset
information (if button is
illuminated)
Fig. 2-5 Buttons on the monitor

2-10 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Product description

Touch screen
Most functions of the dialysis machine are controlled via the touch screen. The screen
displays different contents (windows) depending on the activated program section.
Different parts (fields and icons) of the screen react to touch. By touching one of these
areas, another window is called up or a stored action is triggered. 2
Some windows show a lateral scroll bar. They could be scrolled by moving a finger on
the scroll bar.

Legend
1 Screen
2 Fields
3 Icons
4 Call up help function for
explaining the icons

Fig. 2-6 Screen display

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-11

Product description Dialog+

2.4 Overview of all icons

Icons are control buttons on the touch screen used for operating the dialysis machine.
2 Depending on the displayed window, different icons are available, which all represent
a specific action. By touching an icon, the respective action is carried out. A list of all
icons is provided below.

Leave window and accept data

Leave window without accepting data

Call up help function for explaining the icons

Call up history of current disinfection

Call up service screen

Switch off all icon functions for 10 sec to allow cleaning of monitor

Set brightness of monitor

Leave current window

Call up overview

Call up respective parameter window

2-12 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Product description

Set treatment parameters

2
Return to program selection

Erase therapy card

Read patient data from therapy card

Save patient data to therapy card

Select further setting options

Reduce value

Increase value

Red symbol: error symbol during reading of patient data therapy card

In profile window (except for UF profile): open numerical keypad for

resetting the profile to a setting

Call up keypad for entering numerical values

Give heparin bolus

Give arterial bolus

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-13

Product description Dialog+

Call up window for setting arterial bolus

2
Call up dialyser rinsing program with simultaneous ultrafiltration

Empty dialyser – dialysate is siphoned out of the dialyser

Call up and set heparinisation data

Reset filter, empty (option DF filter)

Filter data (only active if option DF filter has been installed or if the
machine is equipped with HDF-online)

Dialysis on main connection – dialysate flows through dialyser

Dialysis bypass – no dialysate in dialyser

Connect patient to online substitution

Start reinfusion

Change bicarbonate cartridge

2-14 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Product description

Change to therapy mode

2
Change to "Therapy end" mode

Disinfection from water supply – inlet

Disinfection from water supply – discharge

Call up and set dialysate data

Activate stand-by

Call up and set ultrafiltration data

Call up minimum ultrafiltration

Call up and set pressure limits

Call up single-needle selection and settings

Call up ultrafiltration profiles

Call up profile settings for the respective parameter

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-15

Product description Dialog+

Call up linear profile in case of specified start and end values

2
Call up exponential profile in case of specified start and end values

Call up UF path bioLogic RR® Comfort (option)

Select bioLogic RR® Comfort (automatic blood pressure stabilisation,

option)

Select bioLogic RR® Comfort submenu

Call up non-invasive blood pressure monitoring (ABPM, option)

Call up time setting (ABPM, option)

Call up graphic representation of different parameters of therapy

course

Determine selection of graphically represented parameters

Call up screen for entering laboratory values (urea) for Kt/V

calculation

Kt/V measurement (Option Adimea)

Save dialysis effectiveness and list of treatment values and Kt/V

values

Save disinfection data

Call up weekly disinfection program

Call up disinfection screen

2-16 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Product description

Start thermal disinfection

2
Start central thermal disinfection

Start chemical disinfection from water supply

Start brief disinfection/cleaning

Start disinfection program

Start central rinsing

Activate automatic switch-on of dialysis machine at the programmed

time

Activate automatic switch-off of dialysis machine after disinfection

Change settings for HDF-/HF-online

Call up disinfection history of last 150 disinfections

Delete ABPM measured values list (option)

Start ultrafiltration without dialysate (sequential therapy)

Start ultrafiltration with dialysate

Timer/stop watch

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-17

Product description Dialog+

Suppressed warning sounds during preparation

2
Select language of screen text

Option Crit-Line Interface

Crit-Line Table

Crit-Line Trend

Level regulation: enter to level regulation function

Level regulation: decreasing chamber level

Level regulation: increasing chamber level

List of stored Adimea curves

2-18 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Product description

2.5 Entering numerical values

The changing of values is based on the same principle for all parameters. We are,
therefore, providing an example at this point. The example refers to the change of the 2
parameter UF quantity on the ultrafiltration data window.

 Touch icon on screen.

The selected icon lights up in green.
An icon appears for all parameter groups that can be changed.
If none of these icons is pressed within a preset time, the icons are switched off
again. The preset time can be set by the service engineer in the service program.

 Touch desired icon (here: icon for calling up ultrafiltration data window).
The preset values for the parameter are displayed.
The selected icon lights up in green.

 Touch value to be changed on screen (here: value for UF quantity 2000 ml).
A field of icons for changing the value is displayed.
The desired value lights up in green.

Legend
1 Reduce value
2 Increase value

3 Call up keypad for entering

values
4 Example: Calling up
”Ultrafiltration data” screen

Fig. 2-7 Icons for changing the value

The dialysis machine can be set in the service program in such a way that a keypad
appears immediately after the value to be changed has been touched. In this case,
the keypad has no O.K. icon. To confirm entry, press on monitor.

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-19

Product description Dialog+

 Reduce value: Touch icon 1 until the desired value has been reached.
 Increase value: Touch icon 2 until the desired value has been reached.
 Enter different value: Touch icon 3.
2
A keypad is displayed. The permissible setting range is specified in square brackets
below the numerical value (here: 100 ... 20000).

By pressing the icons 1 and 2 permanently, the setting could be adjusted up or down.

Legend
1 Numerical keys
2 Change sign of numerical value
3 Delete set numerical value
4 Leave window and accept data
5 Leave window without accepting
data

Fig. 2-8 Numerical keypad

Delete the set numerical value: Touch key 3 on keypad.

Interrupt entry of numerical value and return to main window: Touch key 5.
If a value outside the permissible range is entered, the message Limits exceeded is
displayed below the entered value.

 Enter value using keypad keys 1.

 If necessary, change sign via icon 2.
 Confirm entry with icon 4.

2-20 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Product description

To rush the access to the groups of parameters so-called “shortcuts” can be used.
Therefore, touch the parameter which should be changed or a concerning graphic
indicator on the main screen. The corresponding window of the group of parameters
will open as shown in Fig. 2-9. 2
The following screen shows the available shortcut squares in frames.

Legend
1 Help icon, active
Shortcuts

Fig. 2-9 Shortcut squares during activated help button

If a shortcut was touched inadvertently, or if no parameters are entered the parameter

window will close automatically after 10 seconds.
The frames marking the shortcuts will only appear if the help function is activated.
 Touch help button (1)
The shortcuts will be marked by brown frames.
 Touch help button again
 The frames disappear.

Shortcuts are only active if the corresponding parameters are relevant for the actual
therapy. For example: The setting of the venous limit can only be done by shortcut
within SN therapies.
Some shortcuts directly open the +/- window for changing the setting. For example:
UF-quantity.

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-21

Product description Dialog+

2.6 Therapy types

2.6.1 Haemodialysis (HD)

2
Haemodialysis is the most common type of therapy used for cleaning blood.
Depending on clinical requirements, treatment generally lasts between three and six
hours (typically ca. 4 hours) and is carried out three times a week (in exceptional
cases, twice a week).

Mode of operation
The dialysis machine pumps blood through a patient’s vascular access into the
dialyser.
Inside the dialyser metabolic waste products are separated from the blood. The
dialyser operates as a filter that is divided into two parts by a semi-permeable
membrane. On one side the patient's blood, on the other side the dialysate flows past.
During the therapy the dialysate is prepared by the dialysis machine. It consists of
prepared water to which certain quantities of electrolyte and bicarbonate, depending
on the individual patient’s requirements, are added.
The concentrations of electrolyte and bicarbonate in the dialysate are adjusted in such
a way that certain substances can be removed from the blood through convection,
diffusion and osmosis, while other substances are added at the same time. This is
mainly achieved by diffusive clearance through the semi-permeable membrane of the
dialyser. The dialysate transports the metabolic products from the dialyser into the
discharge line. The cleaned blood is then recycled into the patient.
During treatment the dialysis machine monitors the blood circulation outside of the
body, pumps blood and dialysate in separate circulation systems through the dialyser
and monitors the composition and volume balance of the dialysate.
The heparin pump, which is also part of the dialysis machine, can be used to add
anticoagulants to the blood in order to prevent the formation of blood clots in the
extracorporeal circulation.
In addition to cleaning the blood, the dialysis machine removes water from the blood,
which would be excreted through the kidney in healthy humans.

2.6.2 Isolated ultrafiltration (ISO UF)

Isolated ultrafiltration (ISO UF, sequential therapy, Bergström therapy) is used for a
short-term extraction of a higher amount of fluid from the patient.
For further information see section 11.3.

Mode of operation
During isolated ultrafiltration no dialysate flows through the dialyser. This therapy
type serves only for extracting fluid from the patient.

2-22 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Product description

2.6.3 Haemofiltration (HF/HF-online)

Haemofiltration (HF) is often used with patients suffering from blood circulation
problems for whom this form of therapy is more comfortable.
Middle-molecular substances such as ß-2 microglobulin are better eliminated from
2
the blood by the HF therapy than by the HD therapy.

Mode of operation
During Haemofiltration (HF) the blood is predominantly cleaned by convection on the
dialyser membrane.
In HF therapy, no dialysate is pumped through the dialyser. Instead, a sterile
substitution solution is infused into the blood cycle upstream or downstream of the
dialyser. Depending on whether the infusion takes place upstream or downstream of
the dialyser, the procedure is called predilution (upstream) or postdilution
(downstream).
The filter membrane in the dialyser has a higher water permeability than a HD filter. It
contains a so-called high-flux membrane (haemofilter) and allows ultrafiltration of
considerably more fluid than through HD therapy.
The electrolyte concentrations in the substitution solution and in the dialysate are
identical. The infusion rate is 4–5 l/h. The same volume is ultrafiltered through the
dialyser. In this way the so-called convective clearance is increased so that the
elimination results are the same as with HD therapy.
In HF-online therapy the substitution solution is prepared ”online”. Dialysate is sterile-
filtered so that it can be used as substitution solution. Unlimited substitution solution
is available, allowing higher infusion rates.

2.6.4 Haemodiafiltration (HDF/HDF-online)

Haemodiafiltration (HDF) is a combination of HD and HF. Both dialysate and

substitution solution are used in this therapy.
This allows the combination of diffusive and convective clearance for small and
medium molecular substances.

Mode of operation
During haemodiafiltration (HDF) the dialysis machine removes more water from the
blood than necessary to replace the natural kidney function. The result is better
cleaning of the blood, although the missing fluid has to be replaced. Therefore,
substitution solution is simultaneously infused into the patient's body. Depending on
whether the infusion takes place upstream or downstream of the dialyser, the
procedure is called predilution (upstream) or postdilution (downstream).
In HDF-online therapy a part of the dialysate is processed as substitution solution.

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-23

Product description Dialog+

2.7 Methods of treatment

2.7.1 Double-needle procedure

2
The double-needle procedure is the standard technique in haemodialysis. Blood is
extracted from the patient through the arterial vascular access. The blood pump
continuously pumps the blood through the arterial tube system to the dialyser. There,
the exchange of metabolic waste products between the blood and the dialysate
proceeds through the semipermeable membrane of the dialyser. After that, the blood
is taken back through the venous tube system, the bubble catcher and a second
vascular access to the vein.

2.7.2 Single-needle procedure

The single-needle procedure is applied when patients had problems with the
predominantly used double-needle dialysis. In the single-needle procedure, only one
needle (single-needle cannula) or a single-lumen, single-needle catheter is applied to
the patient. The arterial and venous ends of the tube system are connected via a Y-
piece. This procedure allows reducing the number of punctures by half compared to
double-needle dialysis, thus, preserving the patient's shunt.
The following single-needle procedures are available:
• Single-needle cross-over as an alternative to double-needle dialysis
• Single-needle valve as "emergency procedure" for terminating a dialysis in case of
problems with a double-needle dialysis.

2.7.3 Single-needle cross-over procedure

The single-needle cross-over procedure with two blood pumps allows a continuous
flow through the dialyser with only one patient connection. During a single-needle
cross-over procedure, the pressure and pulsation conditions within the dialyser are
roughly the same as in a double-needle dialysis.

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Dialog+ Product description

Mode of operation
Legend
1 Patient connection
2 Arterial tube clamp
2
3 Arterial chamber
4 Arterial pressure sensor
5 Arterial blood pump
6 Heparin pump
7 Dialyser with connection for
dialysate
8 Control pressure for venous
blood pump
9 Venous blood pump
10 Venous pressure sensor
11 Venous chamber
12 Air detector
13 Venous tube clamp

Fig. 2-10 Mode of operation – single-needle cross-over

With the arterial tube clamp open and the venous tube clamp closed, the blood pumps
move, at the preset rate, blood from the patient through the dialyser into the venous
chamber. The blood level in the venous chamber rises. The pressure in the venous
chamber is monitored via the venous pressure sensor. Once the set venous switchover
pressure has been reached, the arterial tube clamp closes. Shortly afterwards the
venous tube clamp opens.
The blood from the venous chamber flows back to the patient. The blood pumps
operate simultanously and pump blood from the arterial chamber through the dialyser
into the venous chamber. The pressure in the arterial chamber is monitored via the
arterial pressure sensor. Once the set arterial switchover pressure has been reached,
the venous tube clamp closes and the arterial tube clamp opens. Blood flows again
into the arterial chamber and the process starts again with the withdrawal of blood
from the patient.

Advantages compared to conventional single-needle procedures

The monitoring of the arterial entry pressure and venous return pressure allows a high
blood flow without any gas formation in the blood and without the pump tube
collapsing in the arterial blood pump.
As the second (venous) blood pump protects the dialyser from the high pressure
fluctuations of the venous side, the blood volume recirculating in the system and the
load on the dialysis membrane in the dialyser are low, and clotting can be avoided.

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-25

Product description Dialog+

2.7.4 Single-needle valve procedure

The single-needle valve procedure allows terminating a running double-needle dialysis

in case of problems (e.g. at the shunt). The single-needle valve procedure requires only
2 one blood pump but can also be applied to a dialysis machine containing two pumps.
The second blood pump remains switched off in this case.

Mode of operation
Legend
1 Arterial tube clamp (option)
2 Venous tube clamp
3 Venous red sensor in the housing
of the SAD
4 Safety air detector (SAD)
5 Venous chamber
6 Venous pressure sensor
7 Arterial pressure sensor
8 Arterial blood pump
9 Heparin pump
10 Arterial entry pressure at the
dialyser
11 Arterial chamber
12 Dialyser

Fig. 2-11 Mode of operation – single-needle valve

The patient is connected through either a ”standard AV set with 30 ml chamber” or an

”AV set for SN-valve with a 100 ml chamber”. The arterial and venous lines are
connected through a Y-piece at the vascular access.
With the venous tube clamp closed and the arterial tube clamp (if present) open, the
blood pump pumps blood from the patient through the dialyser into the venous
chamber. The pressure in the venous chamber is monitored via the venous pressure
sensor. As soon as the preset upper switching pressure is reached, the blood pump is
switched off and the venous tube clamp opens. If an arterial tube clamp is installed,
too, this clamp closes now and, thereby, blocks any recirculation of blood into the
arterial tube between Y-piece and blood pump.
Due to the pressure in the venous chamber, the blood flows through the dialyser back
to the patient until the lower switching pressure is reached. Once the lower switching
pressure has been reached in the venous chamber, or the preset return flow time has
expired, the venous tube clamp closes. Shortly afterwards the arterial tube clamp (if
present) opens. The blood pump is activated and the process starts again with the
withdrawal of blood from the patient.
The return flow time is averaged over the first three cycles and automatically set
between 3 and 10 s for the duration of the therapy. If the lower switching pressure
was not reached, the machine switches to the arterial phase after 10 seconds.

2-26 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Product description

2.8 Effectiveness of dialysis (Kt/V)

2
If the theoretical calculation of the effectiveness is selected, the option Adimea as
described in chapter 10 is not applicable.

The dialysis machine allows optimisation of therapy over many treatments. For this
purpose, the theoretical effectiveness is calculated by the dialysis machine. This
theoretical figure can then be compared with the actual effectiveness determined
from blood samples.
For the actual effectiveness, the urea values before and after dialysis have to be
determined in the laboratory and entered into the dialysis machine.

Comparison of theoretical and actual effectiveness over many treatments

The comparison of theoretical and actual effectiveness can be used as a decision aid
for setting the therapy parameters and for selecting the dialyser. Using the patient
therapy card, the dialysis machine can store and list the figures for the last 50
treatments.

Risk to the patient by the input of new treatment parameters.

 The treatment parameters may not be determined on the basis of the
calculated Kt/V.
WARNING  A calculation of the Kt/V does not replace the therapy prescribed by the
physician.

Monitoring the effectiveness during the current treatment

During a treatment, the current effectiveness estimated by the dialysis machine can
also be used as an indicator for the effectiveness that would be achieved if the
treatment would be terminated at a specific time.
The warning during treatment that a certain target value for the effectiveness (Kt/V
value), which was determined prior to treatment, cannot be reached, allows early
corrective intervention into the running treatment.

It cannot be guaranteed that the calculated Kt/V value will actually be reached.

Calculation during particular phases

The Kt/V value is not calculated during:
• Sequential phases of profiles
• Haemofiltration
• Infusionbolus, as the actual blood flow does not correspond to the blood pump
speed
During a phase at a min. UF rate, the Kt/V value calculation is continued. During a
single-needle dialysis, the Kt/V value calculation is based on the average blood flow.

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-27

Product description Dialog+

2.9 Using the timer/stop watch

The Dialog+ screen offers a timer or stop watch function for individual use.
2 These functions are offered in the phases:
• Preparing
• Therapy
• End of Therapy
• Selection of disinfection and
• Disinfection.

 Touch this icon.

The following screen appears

Legend
1 Adjustment of an absolute
time for a warning sound
2 Adjustment of an interval
time for a warning sound
3 Displays rest or expired time
4 Starts/stops/resets timer or
stop watch
5 Starts/stops the timer for
recurring warnings after
input in 1 or 2
6 Switches off the warning
sound after the chosen time
interval
7 Opens an input window for
reminder

Fig. 2-12 Timer/stop watch function

If requested button 6 activates or inactivates the warning sound.

The user could choose between a single warning or a cyclic warning with fixed
intervals.

2-28 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Product description

For a single warning

 Requested adjustment with button 1 or 2.
 Touch button 4 for single warning.

For cyclic warning: 2

 Requested adjustment with button 2 (button 5 automatically activated)
 Touch button 5
The timer/stop watch function starts.
 To stop/reset touch respective button.
The timer function is counting the time shown in field 3 downwards; the stop watch is
counting upwards.

Touch button 7 for input of a reminder

At expiry of an adjusted time an advice appears in the message field “The set time
interval expired” or an information window with the entered reminder-text appears.
The signal lamps switch to yellow and an acoustic signal appears if it has been
activated.

 Press the  button to acknowledge sound and message.

The timer/stop watch function is not interrupted by a possible power failure.

The running timer/stop watch function is shown with a symbol in the date line of the
screen.

Fig. 2-13 Date line with timer symbol

IFU 38910273EN / Rev. 2.11.00 / December 2011 2-29

Product description Dialog+

2-30 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Installation and commissioning

Table of contents

3 Installation and commissioning.......................................................... 3-3

3.1 Scope of supply .................................................................................... 3-3 3
3.2 Storage .................................................................................................. 3-3
3.2.1 Storage in originally packed condition ...............................................3-3
3.2.2 Interim storage of devices ready for operation................................3-3
3.2.3 Decommissioning ......................................................................................3-3
3.3 Transportation ...................................................................................... 3-4
3.3.1 Wheeling......................................................................................................3-4
3.3.2 Carrying........................................................................................................3-5
3.4 Installation site..................................................................................... 3-6
3.4.1 Electrical connection ...............................................................................3-6
3.4.2 Protection against water damage........................................................3-6
3.4.3 Potentially explosive areas.....................................................................3-6
3.5 Water supply......................................................................................... 3-7
3.5.1 Quality of water and dialysate..............................................................3-7
3.5.2 Disposal of used fluids.............................................................................3-7
3.6 Initial commissioning ........................................................................... 3-8
3.7 Setting date and time.......................................................................... 3-8
3.8 Switching on and off ........................................................................... 3-9

IFU 38910273EN / Rev. 2.11.00 / December 2011 3-1

Installation and commissioning Dialog+

3-2 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Installation and commissioning

3 Installation and commissioning

3.1 Scope of supply

• Dialog+ dialysis machine

• Instructions for use
• Suction tube with screw lid for disinfectant 3
• Tube clamps for tubes
• One container lid each with coupling for inserting suction rods (white, red and blue)
• Storage box
• In case of option Central Concentrate Supply: Supply from wall connection coupling
to dialysis machine

Goods-in check
 Unpack dialysis machine and check for completeness and damage.
 In case of damage, call technical service.

3.2 Storage

3.2.1 Storage in originally packed condition

 Store the dialysis machine in ambient conditions as specified in section 15.2.

3.2.2 Interim storage of devices ready for operation

 Disinfect the dialysis machine.

 Store the dialysis machine in ambient conditions as specified in section 15.2.
 Disinfect Dialog+ HDF-online at least once a week.

3.2.3 Decommissioning

 Disinfect the dialysis machine.

 Instruct technical service to empty the dialysis machine.
 Store the dialysis machine in ambient conditions as specified in section 15.2.

IFU 38910273EN / Rev. 2.11.00 / December 2011 3-3

Installation and commissioning Dialog+

3.3 Transportation

3.3.1 Wheeling

3 Risk of damage if dialysis machine is tilted by > 10°!

 Have two or more persons at hand for transporting the machine on stairs and
inclined areas.
CAUTION
 Do not tilt the dialysis machine by more than 10°.

Fig. 3-1 Transport on stairs and slopes (2 persons)

 Release both brakes of front casters.

 Wheel the dialysis machine.
 Apply both brakes of front casters.

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Dialog+ Installation and commissioning

3.3.2 Carrying

For carrying, the dialysis machine can be held at the base, at the rear panel and/or the
protrusion at the front of the machine, as shown in the illustration below.

Fig. 3-2 Holding points for carrying the dialysis machine

Danger of damage due to incorrect transportation (wrong holding points)!

 Do not hold machine on monitor, on bicarbonate cartridge holder or on
CAUTION infusion pole when transporting.

 Use a belt to secure monitor to infusion pole.

 Release caster brakes.
 Tilt the dialysis machine.
 Put down the dialysis machine.
 Apply caster brakes.

IFU 38910273EN / Rev. 2.11.00 / December 2011 3-5

Installation and commissioning Dialog+

3.4 Installation site

The ambient conditions of the premises should be according to DIN VDE 0100 Part 710
and IEC 603647-7-10.

3
Ambient conditions
Observe information about ambient conditions, see section 15.2.

3.4.1 Electrical connection

The existing mains voltage must correspond with the voltage specified on the rating
plate.
The use of extension cables or adapters with the mains cord or the mains socket is
NOT permitted. Modifications of the mains cord are forbidden! If the mains cord has
to be changed, only the original mains cord listed in the spare parts list must be used.
Electrical installations in the room where the dialysis machine will be operated must
conform with relevant regulations, e.g. VDE 0100 Part 710 and/or IEC-stipulations
(like DIN EN 60309-1/-2 and VDE 0620-1 for example).
Using devices of protection class I the quality of the protective conductor is important.
It is recommended to use a mains socket with additional PE-contact pin according to
CEE 7/7 for cables with safety plug (Schuko). Alternatively, it is recommended to
connect a potential equalisation to the dialysis machine. Regulations and deviations
specific to the individual country must also be observed. For further information, ask
technical service.
The dialysis machine must be properly grounded.
Grounding reliability can only be achieved when equipment is connected to an
equivalent receptacle marked “hospital only” or “hospital-grade”. North American
medical equipment cords and plugs have to be "hospital-grade" or "hospital only",
meaning, they are subject to special requirements contained in relevant applied
standards. It is imperative that the ground connection be reliably maintained to
protect the patient and medical staff. Hospital-grade power cords and cordsets carry
the "green dot" signifying that they have been designed and tested for grounding
reliability, assembly integrity, strength and durability.

3.4.2 Protection against water damage

We recommend the use of water detectors to protect against any unnoticed water
leaks.

3.4.3 Potentially explosive areas

The dialysis machine may not be operated in areas at risk of explosion.

3-6 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Installation and commissioning

3.5 Water supply

3.5.1 Quality of water and dialysate

The user must ensure that the water quality is continuously monitored.
The following requirements must be fulfilled:
• The incoming water must be free from Mg++ and Ca++.
3
• pH value of between 5 and 7
Water and dialysate must comply with the country-specific standards, i.e.:
• ISO 13959
Water for haemodialysis and related therapies
• DIN VDE 0753-4
Anwendungsregeln für Hämodialysegeräte
• ANSI/AAMI RD5-03
Hemodialysis systems
• ANSI/AAMI RD61
Concentrates for hemodialysis
• ANSI/AAMI RD62
Water treatment equipment for hemodialysis applications
• AAMI WQD
Water quality for dialysis
• American National Standard for Hemodialysis Systems (RD-5)
• European pharmacopoeia 2002. Official German 4th edition.

3.5.2 Disposal of used fluids

Risk of infection due to backflow of contaminated fluids from the drain into the
dialysis machine!
 Ensure air clearance between haemodialysis equipment waste connector and
WARNING
the drain (8 cm).

Pipe system may be damaged by corrosive fluids!

 Use adequate drainage piping materials.
CAUTION

Ensure sufficient drainage capacity!

IFU 38910273EN / Rev. 2.11.00 / December 2011 3-7

Installation and commissioning Dialog+

3.6 Initial commissioning

Initial commissioning should be carried out by the responsible technical service.

3.7 Setting date and time

Fig. 3-3 Date and time

Setting date
 Touch field showing date and time 1.
The field containing icons 2, 3 and 4 appears.
There are two setting options:
 To increase or decrease the date, change date with icons 2 and 3.
 To enter the date using the keypad, touch icon 4.
The numeric keypad appears on the screen.
 Enter date using keypad and confirm by selecting OK.

Setting time
 Touch field containing date and time 1.
There are two setting options.
 To increase or decrease time by minutes, change date with icons 2 and 3.
 To enter the time using the keypad, touch icon 4.
The numeric keypad appears on the screen.
 Enter date using keypad and confirm by selecting OK.
 Touch field containing date and time 1.
The field containing 2, 3 and 4 disappears.
The set date and time are displayed.

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Dialog+ Installation and commissioning

3.8 Switching on and off

• In case of any damage that may put into question the safe use of the machine, the
dialysis machine may not be used. Inform the customer service in charge.
• Only switch on dialysis machine after it has reached room temperature. 3
• Observe requirements on installation site and water supply.

Switching on and off

 Press mains switch.
The dialysis machine switches from ON to OFF status or vice versa.

Accidental pressing of the mains switch

In case of accidentally switching off the dialysis machine by actuating the mains
switch during a dialysis session, proceed as follows:
 Press mains switch again.
An alarm message is displayed on the screen: “System recovered”, for interruptions
less than 15 minutes, and the therapy continues.
 Confirm alarm by pressing ”Confirm alarm”.
In case of longer interruptions, the dialysis machine switches to the therapy
selection window.

In case of accidentally switching off the dialysis machine by actuating the mains
switch during disinfection, proceed as follows:
 Press mains switch again.
The disinfection process is continued.

In case of accidentally switching off the machine, a characteristic signal is activated

three times.

IFU 38910273EN / Rev. 2.11.00 / December 2011 3-9

Installation and commissioning Dialog+

3-10 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Preparing for haemodialysis

Table of contents

4 Preparing for haemodialysis ............................................................... 4-3

4.1 Calling up haemodialysis ..................................................................... 4-4
4.2 Automatic test...................................................................................... 4-4
4.2.1 Operation during automatic test..........................................................4-5 4
4.2.2 Terminating the automatic test sequence.........................................4-6
4.2.3 Completion of automatic test sequence ............................................4-6
4.3 Reduction of warning sounds during Preparation ............................ 4-6
4.4 Connecting the concentrate ............................................................... 4-8
4.5 Setting the rinsing parameters........................................................... 4-9
4.6 Inserting and rinsing the tube system.............................................. 4-11
4.6.1 Inserting the tube system.................................................................... 4-11
4.6.2 Rinsing and testing the tube system................................................ 4-14
4.6.3 Level regulation (if present)................................................................ 4-14
4.7 Preparing the heparin pump ............................................................. 4-16
4.7.1 Inserting the heparin syringe.............................................................. 4-16
4.7.2 Venting the heparin line ...................................................................... 4-17
4.8 Setting the treatment parameters ................................................... 4-18
4.8.1 Setting the dialysate parameters ...................................................... 4-19
4.8.2 Monitoring the dialysate ..................................................................... 4-21
4.8.3 Setting the ultrafiltration parameters ............................................. 4-21
4.8.4 Setting the pressure limits .................................................................. 4-24
4.8.5 Setting the heparin parameters......................................................... 4-26
4.9 Rinsing the dialyser ............................................................................ 4-28
4.10 Stand-by mode ................................................................................... 4-29
4.10.1 Activating the stand-by mode ........................................................... 4-29
4.10.2 Switching off the stand-by mode ..................................................... 4-29
4.11 Power failure in Preparation ............................................................. 4-30
4.12 Changing the bicarbonate cartridge during preparation............... 4-30

IFU 38910273EN / Rev. 2.11.00 / December 2011 4-1

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Dialog+ Preparing for haemodialysis

4 Preparing for haemodialysis

Safety air detector (SAD) not active! Danger of air embolism!

 Do not connect the patient out of the “Therapy” phase, e. g. during
“Preparation/Disinfection” phase!
WARNING  Out of the “Therapy” phase it is not allowed to use the blood pump for
infusion (e. g. saline solution)!

4
Haemodialysis is the standard dialysis procedure for all system variants.
The procedure is the same for all system variants.

Loss of blood or damage of blood by temperature, pressure or wrong

composition of dialysis fluid!
WARNING  Ensure that the patient will only be connected in Therapy phase.

A connection of the patient in Preparing/Disinfection leads to an alarm by blood

detection at the red detector. At the same time the blood pump will be stopped and
SAKV will be closed.

IFU 38910273EN / Rev. 2.11.00 / December 2011 4-3

Preparing for haemodialysis Dialog+

4.1 Calling up haemodialysis

After switch-on, the following main screen is displayed on the dialysis machine:

Fig. 4-1 "Haemodialysis" main screen

 Touch field 1.
The first preparation screen for haemodialysis appears. The dialysis machine starts an
automatic test sequence.

4.2 Automatic test

At the automatic test stage, the dialysis machine automatically checks all control
functions relevant to the safety of the machine.

While the dialysis machine is carrying out automatic tests you can begin entering the
treatment parameters.

If the option „Blood side pressure test with pressure compensation“ is activated in
TSM, the excess pressure in the AV system will be removed via the dialyser after the
pressure test on the blood side.
Depending on the used type of dialyser, this may take up to two minutes.

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Dialog+ Preparing for haemodialysis

4.2.1 Operation during automatic test

Legend
1 Status field
2 Operating field

Fig. 4-2 First preparation screen "Haemodialysis"

While the dialysis machine goes through the automatic test sequence, messages on a
yellow background appear in field 2 if the machine expects you to carry out actions
such as connecting the concentrate. The test sequence is only continued once this
action has been completed.

Fig. 4-3 Information window during automatic test

IFU 38910273EN / Rev. 2.11.00 / December 2011 4-5

Preparing for haemodialysis Dialog+

Information windows can be hidden, by a touch, for approx. 20 seconds while you use
the screen for other actions, e.g. entering parameters. Upon completion of the entry,
the information window will reappear. Taking over the data with the Enter  button
will only be possible after confirming the information window.

4.2.2 Terminating the automatic test sequence

 Touch icon.
The automatic test sequence is terminated.
The options "Return to therapy selection" and "Repeat blood-side tests" are displayed.
4  Touch the appropriate field.

4.2.3 Completion of automatic test sequence

This screen icon is enabled as soon as the dialysis machine has completed all
automatic tests successfully. The patient can now be connected.

4.3 Reduction of warning sounds during Preparation

For the user there is a possibility to suppress some warning sounds during preparation,
except only warning sounds which require interaction with the user. For example,
fault removal or on demand for action. Optical alarms and the fault finding are not
affected.
The function “Reduced warning sounds during preparation“ can be used for the
following warnings.

ID Text
1927 Rinsing volume attained
1928 Filling volume is reached
1112 UF Rinse volume for dialyser too high
1153 Repeat self test!
1033 Temperature too low
1034 Temperature too high
1038 Connect acid-/acetate concentrate
1040 Connect bicarbonate
1041 Connect blue concentrate coupling to rinse bridge
1045 Bicarbonate cartridge holder open

Preparing the machine with reduced warning sound could cause a delay of the
following treatment. To schedule planned preparation time requires increased
attention of the staff.

4-6 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Preparing for haemodialysis

Fig. 4-4 "Haemodialysis" main screen

 Touch icon at main screen.

The following screen is displayed

Fig. 4-5 Screen for suppression of acoustic signals

 Touch icon

IFU 38910273EN / Rev. 2.11.00 / December 2011 4-7

Preparing for haemodialysis Dialog+

If the function is not active (icon background not coloured in green), it could be
activated by touching the icon. The warning sounds listed in the table above are
automatically suppressed. To indicate this, a crossed out speaker symbol appears at
the date line of the screen.

4 Fig. 4-6 Date line with suppressed acoustic signal

Now the icon is shown as active (green coloured background).

To touch the icon once more inactivates the function and turns on audible signals for
the warning sounds listed above. The indicator at the date line disappears.

The function “Reduced warning sounds during preparation“ could be preset in the
TSM-mode by a technician.

The function “Reduced warning sounds during preparation“ is only available during
program selection and preparation and can be configured during selection of program
and preparation. For all other phases of treatment this function is not available (icon
appears grey). Changing into the next therapy the function automatically set resets to
the TSM pre-adjustment.

4.4 Connecting the concentrate

After completion of the internal pressure test, the request connect acetate/acid
concentrate appears on a yellow background.

Risk to the patient due to incorrect composition of dialysate!

 Ensure that the correct concentrates are provided for the intended therapy.
 Only use concentrates whose printed use-by date has not expired.
 Only use originally closed and intact concentrate containers.
 Observe storage information on concentrate containers.
WARNING  It is recommended to use concentrates produced by B. Braun Avitum AG.
 When concentrates are used that are not produced by B. Braun Avitum AG
the correct mixing ratio and composition has to be checked on the
concentrate label.

The physician in charge is responsible for determining the concentrates to be used.

4-8 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Preparing for haemodialysis

For bicarbonate dialysis:

 Insert red concentrate rod into the canister containing acidic bicarbonate
concentrate, e.g. SW 325A.
 Insert blue concentrate rod into the canister containing alkaline bicarbonate
concentrate, e.g. bicarbonate-containing solution 8.4%.
The dialysis machine continues the automatic test sequence.

For acetate dialysis:

 Place concentrate rod marked in red and white into container filled with acetate
concentrate, e.g. SW 44.
4
 Leave blue concentrate rod in blue concentrate rod holder.
The dialysis machine continues the automatic test sequence.

4.5 Setting the rinsing parameters

This option allows a rinsing of the dialyser membrane with or without ultrafiltration.
 Touch icons.
The rinsing parameters are displayed.

Fig. 4-7 ”Rinsing parameters” screen

IFU 38910273EN / Rev. 2.11.00 / December 2011 4-9

Preparing for haemodialysis Dialog+

 Set intended values for rinsing parameters according to the table below.

Item Text Range Description

1 AV system Rinse blood side

–
filling/rinsing
2 Filling BP rate 50 – 600 ml/min The rate with which the
blood side is filled or rinsed
3 Filling BP volume 0 – 6000 ml The blood pump stops after it
4 has rinsed the blood side
using the set volume
4 Rinsing with Rinsing of dialyser membrane
–
ultrafiltration
5 Rinsing BP rate 50 – 300 ml/min BP rate for rinsing program

6 Rinsing DF rate 300 - 800 ml/min DF rate for rinsing program

7 Rinsing time 0 – 59 min Duration of adjusted rinsing

program
8 UF rate for rinsing 0 – 3000 ml/h when rinsing
with a physiological saline –
solution
9 UF-volume f. rinsing 0 – 2950 ml when rinsing
with a physiological saline –
solution
10 Blood flow for 50 – 600 ml/min
–
connecting patient

 Confirm all settings by pressing the O.K. icon.

The initial preparation window reappears.
At the end of the chosen rinsing time the yellow signal lamp flashes.

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Dialog+ Preparing for haemodialysis

4.6 Inserting and rinsing the tube system

4.6.1 Inserting the tube system

The blood pump tube segment in the AV system must have the dimensions
8 x 12 mm (inner/outer dimension) for the standard machine. A roller rotor for pump
segments 7 x 10 mm is available as an option.
4

Risk to patient due to incompatibility of tube system and dialysis machine!

 Only use consumables produced by B. Braun Avitum AG.
WARNING

Risk to patient due to haemolysis or blood loss when using a faulty blood tubing
system!
 Check to ensure that the tube system is not damaged.
WARNING  Check to ensure that no line is kinked.
 Make certain that all connections are tightly seated.

Risk to patient due to infection as a result of contamination of the hydrophobic

pressure sensor filter on the tube system!
 Replace the machine-side hydrophobic pressure sensor filter if it was
contaminated with blood and blood penetrates the machine.
WARNING  Instruct technical service to replace transducer protector.
 Only use the machine again when the filter has been changed.
 Execute disinfection after replacement.

Risk of contamination at the patient connectors on the blood tubing system per
use of a rinsing bucket.
WARNING  Ensure hygienic handling of the blood lines.

IFU 38910273EN / Rev. 2.11.00 / December 2011 4-11

Preparing for haemodialysis Dialog+

Legend
1 Venous tube valve
2 Safety air detector with venous
red detector
3 Venous chamber
4 Venous pressure sensor
5 Arterial pressure sensor
4 6 Arterial blood pump
7 Heparin pump
8 Pressure sensor for arterial entry
pressure in front of the dialyser
(optional)
9 Arterial chamber
10 Dialyser

Fig. 4-8 Schematic view of extracorporeal circulation system used in

haemodialysis

A dialyser holder that can be attached to the infusion pole above the top fixing, is
available as an accessory.

To swivel or shift the dialysis holder, always undo the screw clamp on the infusion
pole so that the latter will not be damaged.

 Fix dialyser in dialyser holder.

 Attach bag containing physiological saline solution (up to 2.5 kg) to infusion pole.
 Connect arterial connection of blood tube system to bag containing the
physiological saline solution. Do not break the seal, yet.
 If present: Connect pressure measuring line for arterial pressure to the PA pressure
sensor.
 Open lid of (left) blood pump.
 Insert tube end with patient supply into the matching opening of the rotor.
 Turn rotor in direction of arrow.

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Risk to patient due to blood loss when using a faulty blood tube system!
 Check to ensure that the tube system and pump segments are not being
damaged at the insertion.
 Ensure that the pump segment is placed in the backmost position of the
pump housing.
CAUTION
 When inserting the pump segments do not rotate the rollers against a drag.
 If the tube system has been damaged through the insertion, replace it by a
new one.
4

 Close lid of (left) blood pump.

The spacers on the inside of the lid do not serve to place the pump segment in the
right position. They prevent the pump segment from moving out of the right position
during operation, therefore, preventing only damage to the rollers.

 Connect pressure sensor connector (if present) to PBE sensor connection.

 Connect arterial and venous tube system to dialyser observing the colour-coding.
Do not yet remove the stops (if existent) on the lateral Hansen connectors.
 Connect pressure measuring line for venous pressure to PV pressure sensor making
certain the pressure measuring line is not kinked and the filter is screwed on
securely.
 Insert venous bubble catcher into fixing.
 Open lid of air detector.
 Insert tube into air detector and close lid.
 Connect venous patient connection to the empty bag.
 Insert blood tube system into fixings.

Risk of damage to the tube system due to prolonged clamping of the venous
tube by the tube clamp!
CAUTION  Only place the venous line into the tube clamp (SAK) on therapy day.

If a tube system without PBE sensor is used, the message "No pressure measuring
connection on PBE" is displayed during the pressure test.
The message automatically disappears after 60 seconds.

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Preparing for haemodialysis Dialog+

Risk of contamination of the priming bag if administration set is connected and

bloodside pressure test failure because of wet transducer protector membrane!
 Set level in the drip chamber of the administration set.
 If there is no air inside the drip chamber, change priming bag because of
WARNING
possible contamination.
 Change priming bag in case of bloodside pressure test failure.

4
4.6.2 Rinsing and testing the tube system

 Break the seal of the bag containing physiological saline solution.

 Start blood pump by pressing the + button on the monitor.
The tube system will fill with physiological saline solution. The blood side of the
dialysis circuit is rinsed and automatically tested for any leaks.

4.6.3 Level regulation (if present)

The level regulation system allows the user to set saline levels in the blood line
chambers for preparation by screen touch.

• During preparation the levels can only be set while the blood pump is running.
• The user is obligated to check for correct setting of the levels in the chambers.

 Touch icon
The level window opens.

Legend
1 PV - Venous chamber
2 PA – Arterial chamber
3 PBE – Arterial blood
entry chamber

Fig. 4-9 Level regulation screen

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Dialog+ Preparing for haemodialysis

The setting of the following chambers is possible:

 Venous chamber (PV) (1): the button is always active.

 Arterial chamber (PA) (2): the button is active from the beginning of preparation,
but will be automatically deactivated if SN-CO is not selected or if the PBS is not
connected after starting the therapy (if selected in TSM).
 Arterial blood entry chamber (PBE) (3): the button is always active (if selected in
TSM).

4
The adjustment of the PBE chamber is only possible if an AV system with PBE line is
used and the line is connected to the machine.

Level increasing
 Touch icon gently with one touch
 Observe level
 Touch again for the correct setting if necessary

Level decreasing
 Touch icon gently with one touch
 Observe level
 Touch again for the correct setting if necessary

 To leave the level regulation function, touch icon again

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4.7 Preparing the heparin pump

The heparin pump is suitable for tube systems with heparinisation downstream of the
blood pump in the positive pressure region.

4.7.1 Inserting the heparin syringe

4 Legend
1 Syringe bracket
2 Syringe gripping plate
3 Clip
4 Unlocking lever
5 Syringe stop

Fig. 4-10 Heparin syringe

Fig. 4-11 Position of the syringe stop depending on syringe size

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 Set syringe stop 5 in such a way that the syringe size can be read.
 Release unlocking lever 4 and pull out drive mechanism.
 Lift and turn syringe bracket 1.
 Insert syringe in such a way that grip and pressure plate engage in the guide.
If the syringe was inserted correctly, the unlocking mechanism will jump back
automatically. Do not close the unlocking mechanism manually.
 Close syringe bracket.

4
4.7.2 Venting the heparin line

 Before inserting the syringe, manually vent heparin line.

or
 Vent heparin line prior to starting the dialysis by providing a heparin bolus.

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4.8 Setting the treatment parameters

 Touch icon in preparation window.

A line of additional icons 1 is displayed.

Fig. 4-12 Preparation window "Parameters"

With these icons, the following parameter groups can be called up:

Icon Parameter group Reference

Dialysate parameters Page 4-19

Ultrafiltration parameters Page 4-21

Pressure limit settings Page 4-24

Heparinisation data Page 4-26

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4.8.1 Setting the dialysate parameters

 Touch icon in preparation window.

The dialysate parameters are displayed.

Fig. 4-13 "Dialysate parameters" screen

 Set dialysate parameters according to the following table.

Item Text Range Description

1 Conductivity 12.5–16.0 mS/cm in steps of

0.1 mS/cm (approx. 125–160 –
mmol/l)
2 Bicarbonate Dialysis with an acidic
bicarbonate haemodialysis
– concentrate and an alkaline
bicarbonate haemodialysis
concentrate formulation
3 Acetate Dialysis with acetate
–
concentrate
4 Bicarbonate 2–4 mS/cm in steps of
Conductivity 0.1 mS/cm –
(approx. 20–40 mmol/l)
5 Dialysis fluid 33–40 °C in steps of 0.5 °C
–
Temperature
6 Dialysate 300–800 ml/min
–
Flow continuously adjustable
7 Profiles Alternatively, profiles can be
– selected for the respective
parameter, see section 11.2.

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The actual temperature at the dialyser may differ marginally from the before adjusted
temperature.

Damage to the machine due to calcium depositions during bicarbonate dialysis!

 Decalcify the machine after each bicarbonate dialysis.
CAUTION
4

• The physician in charge is responsible for determining the concentrates to be used.

• The bicarbonate and acetate mode can be preset in the service program by
technical service.
• Technical service can use the service program to set the limit value for mixing
ratio monitoring in such a way that acetate dialysis cannot be performed.
• If the setting mmol has been selected in the service program, up to 10 acetate and
bicarbonate concentrates can be preselected. An additional field with the name of
the selected concentrate is displayed. Upon touching this field, a list of all
available concentrates is displayed.
• If bicarbonate cartridges are used, see section 10.

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4.8.2 Monitoring the dialysate

It is possible to check the correct composition of the dialysate.

 Once the conductivity of the dialysate has stabilised (after approx. 5 minutes),
slowly take a sample from the sampling valve of the coupling, using a small syringe,
(e.g. a 2-ml syringe and a 20–22 G cannula) or, if applicable, from the sample port
at the DF.
 Analyse the dialysate by, e.g. the following methods:
– pH measurement
– blood gas analysis
4
– chemical determination of bicarbonate concentration (titration)

Recommended therapeutic ranges

pH 7.2–7.5

pCO2 40–60 mmHg

HCO3– 25–38 mmol/l

Damage to machine due to calcium depositions at pH value >7.5 during

bicarbonate dialysis!
CAUTION  Observe correct setting of pH value.

4.8.3 Setting the ultrafiltration parameters

 Touch icon in preparation window.

The ultrafiltration parameters will be displayed.

Fig. 4-14 ”Ultrafiltration parameters” screen

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 Set ultrafiltration parameters according to the table below.

Item Text Range Description

1 Ultrafiltration Volume 100–20000 ml

2 Therapy 10 min–10 h Therapy time

Time

4 3 Ultra filtration
Profile
For selecting an ultrafiltration
profile or choosing sequential
therapy, see section 11.3
4 Minimal 0–500 ml/h Min. ultrafiltration rate
UF rate
5 Up. limit 0–4000 ml/h Max. ultrafiltration rate
UF rate (must be set in TSM)
6 Button to set therapy The therapy time can be set. The
time end of therapy time is calculated.
7 Button to set end of The absolute time to end therapy
therapy time can be set. The effective therapy
time is calculated.
8 End of therapy time The absolute end of therapy time is
indicated.

Set the therapy time

 Touch the buttons 6 and 2 in figure 4-14.
Set value by + / - or use the keypad to enter the value.

Set the absolute end of therapy time

 Touch the buttons 7 and 8 in figure 4-14.

Fig. 4-15 Ultrafiltration parameters

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A keypad will open. The end of therapy time can be set in a time range considering the
ultrafiltration volume, the minimal UF rate and the upper limit UF rate.

Fig. 4-16 Set End of Therapy time

The effective therapy time is calculated as the difference between the set end of
therapy time and the current time.

The set end of therapy time will not be extended by Bypass phases.

It is always possible to change back to set the therapy time.

To avoid alarms, adjust the upper limit for the ultrafiltration rate to value above the
calculated actual ultrafiltration rate.

Selecting low UF-rates with long UF-time can cause deviation between debit value
and actual value. Corresponding warnings will appear on the screen. The deviation
will be indicated and has to be confirmed by the user pressing the Enter button .

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4.8.4 Setting the pressure limits

 Touch icon in preparation window.

The pressure limit values will be displayed.

Fig. 4-17 ”Pressure limits” screen

 Set pressure limits according to the table below.

Item Text Range Description

1 Limit delta 10–100 mmHg Limits window for arterial

Min./Max. PA entry pressure PA.
Distance to min. and max. PA
2 Actual TMP/ 300–700 mmHg Max. TMP: see information
maximum TMP provided by dialyser
manufacturer
3 Limits TMP ON/OFF Monitoring the TMP at the
dialyser
4 Low/High 2–99 % Limits window for TMP in %
of actual value
5 Extended TMP-limit ON/OFF The TMP limits enlarge to
range -100 mmHg if activated in
TSM

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Limits window for arterial entry pressure PA

The arterial entry pressure PA (pressure between patient and blood pump) is monitored
by an automatically set limits window. This window is only active in the therapy phase
and during final circulation.
A max. lower arterial limit is set in the service program (max. –400 mmHg). The
automatically set lower limit cannot fall below this value.
The size of the arterial limits window is defined through the respective distance (delta)
between the actual value and the lower and upper limits.
The total of the two distances to the actual value gives the width of the arterial limits
window, i.e. in the above example 70 + 70 = 140 (mmHg).
4

Danger of injuring patients access by perforation per negative pressure!

 Ensure that max. PA is adapted to the actual shunt flow respectively follows
WARNING the physicians order.

Limits window for TMP control

The TMP of the dialyser is controlled by an automatically set limits window.
The size of the limits window is entered as a percentage of the actual value (see Fig.
4-17). The limits window is, therefore, independent of the dialyser in use.
When the limits window is switched off, the control of the dialyser-dependant max.
TMP is still active.
Activating the Bypass icon or changing the dialysate flow causes the limits window to
be re-centred.
The lower TMP-limit range can be enlarged for the use of highflux dialysers (see Fig.
4-17). This function has to be enabled in TSM.

 Touch icon
The lower TMP-limit will be set to –100 mmHg. Through this the backfiltration
warning when reaching -10 mmHg is not applicable.

Danger of patient blood contamination by germs in dialysis fluid!

 Ensure that the dialysis fluid is clean.
WARNING

Risk of blood volume increase due to leakage in the hydraulic system

(water cycle). Risk of backfiltration.
 Check patient weight.
WARNING
 In case of technical defect, call technical service.

While using the function “Extended TMP-limit range” you will have to act on the
assumption of back filtration.
For this reason we recommend the use of dialysis-fluid filter (Diacap® Ultra).

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4.8.5 Setting the heparin parameters

 Touch icon in preparation window.

The heparin parameters are displayed.

Fig. 4-18 "Heparin parameters" screen

 Set heparin parameters according to the table below.

Item Text Range Description

1 Heparin 0:00–10:00 h:min The heparin pump is switched off

Stop time by the set time prior to the end
of the therapy

2 Heparin 0.1–10.0 ml Bolus volume for a bolus

Bolus Vol. administration during dialysis

3 Heparin 0.1–10.0 ml/h Continuous heparin rate over the

Profile/rate entire duration of heparin
administration

4 Treatment not activated/activated Switching on/off the heparin

without heparin monitoring function

5 Syringe type 10/20/30 ml A list of permissible syringe types

is stored in the service program

6 Setting a profile for heparin

– – administration

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Risk to the patient with high risk of internal bleeding (e. g. at recent surgery,
gastro-intestinal abscess or similar diseases)!
 Check for indication of internal bleeding during therapy.
WARNING
 Check the process of heparin application during therapy.

Blood clotting in the extracorporeal system! 4

 Ensure that the heparin pump is switched on after entering a delivery rate.
CAUTION

If in TSM presetting the heparin pump is set “off”, you’ll have to switch it on
manually!

Risk to the patient due to wrong anticoagulant dosage caused by a mismatch

between the heparin pump selected on the screen and the syringe actually
inserted in the heparin pump!
 Always make certain the syringe selected on screen is the same as the type of
WARNING syringe actually inserted.
 Only use syringes listed in the syringe table.
If necessary, contact technical service.

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4.9 Rinsing the dialyser

After rinsing the blood side, an information window appears with the request to
connect the dialyser.
 Take dialyser tubes from rinsing bridge and connect to dialyser. Observe colour-
coding.
 Connect the dialyser inlet coupling (blue) to the Luer Lock connection of the venous
line.
4  Connect the dialyser outlet coupling (red) to the Luer Lock connection of the
arterial line.
 Turn dialyser so that the blue connection is facing downward.
 Confirm correct connection of dialyser by pressing the Enter key on the monitor.
The dialyser is filled and rinsed.
 Adjust level as follows:
– Fill chamber in front of the dialyser entry (PBE) nearly half full,
– Fill venous drip chamber up to approx. 1 cm from the upper edge.

Once the set rinsing volume has passed the system the blood pump stops running. An
information window appears.
 Ensure that the blood tube system and the dialyser are filled and rinsed with
physiological saline solution.
 Ensure that all levels in the chambers have been set correctly.
 Confirm correct settings by pressing Enter key on the monitor.
The dialysis machine is testing the blood tube system.

This screen icon will be enabled as soon as the dialysis machine has successfully
completed all automatic tests. The patient can now be connected.

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4.10 Stand-by mode

The dialysis machine features a stand-by mode for the dialysate side. This mode allows
switching off the dialysate side in order to save on permeate and concentrate when
the machine is being prepared and will not be used immediately.

Risk of germination in the dialysate during stand-by mode!

Infection risk to the patient!
4
 Do not run the dialysis machine in stand-by mode over prolonged periods.
WARNING  The recommended duration of stand-by mode depends on the water quality
and the environmental conditions (according to the hygiene plan of the
dialysis centre).

4.10.1 Activating the stand-by mode

Depending on the service program setting performed by technical service, there are
the following ways in which the stand-by mode can be activated for an adjustable
period:
• Automatic start after automatic test sequence
• Automatic start after rinsing program
• Manual start after automatic test sequence
• Manual start after rinsing program

Manual activation of the stand-by mode

 Touch icon.
The dialysis machine is in stand-by mode.

4.10.2 Switching off the stand-by mode

The max. duration of the stand-by mode is preset in the service program by technical
service.
Depending on the setting entered by the technical service in the service program,
there are the following options for switching off the stand-by mode:
• Manual switch-off
• Automatic switch-off after expired time
• Automatic switch-off during connection of patient

Manual switch-off of stand-by mode

 Touch icon again.
The machine is in bypass mode. The dialysate is circulated without passing through
the dialyser.

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4.11 Power failure in Preparation

During a power failure in Preparation phase the status of this phase will be saved. If
the power supply will be restored, only the interrupted work step must be repeated by
the device if necessary.
Already entered treatment parameters will remain unchanged.
The saved data will be stored up to 120 minutes. After that time the device has to be
prepared new.
4

This functionality allows a removing of a prepared device to another treatment place.

4.12 Changing the bicarbonate cartridge during preparation

It is possible to exchange a bic cartridge during preparation. (see also chapter 10.4)

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Table of contents

5 Initiating haemodialysis ...................................................................... 5-3

5.1 Checking the patient data................................................................... 5-3
5.2 Connecting the patient and starting haemodialysis......................... 5-4
5.2.1 Level regulation (if present)...................................................................5-5
5.3 During haemodialysis ........................................................................... 5-7
5.3.1 Monitoring the blood-side pressure limits ........................................5-7 5
5.3.2 Treatment at minimum UF rate ............................................................5-9
5.3.3 Heparin bolus .......................................................................................... 5-10
5.3.4 Arterial bolus........................................................................................... 5-10
5.3.5 Graphical representation of treatment parameters (trend)....... 5-12
5.3.6 Interrupting the haemodialysis (bypass) ......................................... 5-15
5.4 Completion of treatment................................................................... 5-15
5.4.1 Terminating treatment ......................................................................... 5-15
5.4.2 Continuing treatment ........................................................................... 5-15

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5 Initiating haemodialysis

5.1 Checking the patient data

After completion of the preparation work, the icon for connecting the patient is
enabled. The dialysis machine is in bypass mode. The signal lamps on the monitor
change to yellow.
 Touch icon in preparation screen.
Two brief acoustic signals are sounded. The Enter key  on the monitor is lit up. An
overview of the entered patient data appears on the screen.

Fig. 5-1 "Patient data" screen

Risk to the patient due to inadequate monitoring of treatment parameters!

If only one or no acoustic signal is sounded or Enter key  flashes on the
monitor, or if the displayed treatment parameters show discrepancies, the
dialysis machine is defective and must not be used!
WARNING
 Leave screen by pressing CANCEL.
 Call technical service.

 Check that patient data corresponds with what has been prescribed by the doctor
and confirm by pressing the Enter key on monitor.
The treatment screen appears.

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5.2 Connecting the patient and starting haemodialysis

Risk to patients with central venous catheters due to excessive patient leak
current!
WARNING  Connect electrical ground on the dialysis machine, see section 1.5.2.

Before starting therapy after a disinfection the clamps SAKA and SAKV as well as the
5 metallic parts of the substitution inlet/outlet ports may not exceed a temperature of
41°C.

Legend
1 Remaining therapy time,
graphical and in numbers
2 Current UF rate
3 Current UF volume
4 Set UF volume
5 Heparin rate
6 Blood flow
7 Heparin bolus
8 Treatment with min. UF rate
9 Bypass
10 Information bar
11 Display of trans-membrane
pressure (TMP), with limits
12 Display of arterial pressure,
with limits
13 Display of venous pressure, with
limits
Fig. 5-2 "Haemodialysis" treatment screen

During the connection phase, the set limit values are not rigorously monitored.
Therefore, particular care is required during the connection phase.

 Connect patient arterially.

 Start blood pump by pressing START/STOP button on monitor.
 Set blood flow
 Fill blood tube system with blood.

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The blood pump stops automatically if blood is detected on the red sensor in the
safety air detector (SAD).
 Connect patient venously.
 Start blood pump.
 Touch icon.
The dialysis machine switches to main connection and the haemodialysis is running.
The signal lamps on the monitor switch to green.

Risk to patient due to haemolysis if the blood flow setting is too high for the
selected needle (PA pressure too low!)!
WARNING  Adapt blood flow taking into consideration the arterial pressure. 5

Risk to patient due to reduced dialysis effectiveness since the actual blood flow
is lower than the displayed flow rate if arterial pressures are highly negative!
 Correct the blood flow setting.
WARNING
 Extend treatment time.

Risk to patient due to reduced dialysis effectiveness since the blood flow is too
low (for example wrong cross-section of the cannula)!
 Ensure that the blood flow is high enough.
WARNING
 Ensure that the cross-section of the cannula is big enough.

5.2.1 Level regulation (if present)

The level regulation system allows the user to set blood levels in the blood line
chambers in treatment by screen touch.

• During treatment, the blood levels can only be set while the blood pump is running
in double-needle mode. The active chambers depend on the used blood line
system.
• The user is obligated to check for correct setting of the levels in the chambers.

 Touch icon
The level window opens.

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Fig. 5-3 Level regulation screen

Level increasing
 Touch icon gently with one touch
 Observe level
 Touch again for the correct setting if necessary

Level decreasing
 Touch icon gently with one touch
 Observe level
 Touch again for the correct setting if necessary

 To leave the level regulation function, touch icon again

• In case the blood pump is stopped, the level regulation system is not active. A
message is displayed that a previous start of the blood pump is required.
• In case of blood side alarms, level regulation is not possible. Alarms have to be
cleared first.

Risk to patient due to infection as a result of contamination of the transducer

protector on the tube system!
 Replace the machine-side transducer protector if it was contaminated with
blood and blood penetrates the machine.
WARNING  Instruct technical service to replace transducer protector.
 Only use the machine again when the filter has been changed.
 Execute disinfection after replacement.

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Risk of reduced dialysis effectivity!

 Ensure that no air enters into the dialyser when decreasing the level in the
WARNING PBE chamber.

5.3 During haemodialysis

Risk to patient due to blood loss if cannulas get disconnected or slip out!
Standard monitoring function of the dialysis machine cannot safely detect that
such a situation has arisen! 5
 Ensure that the access to the patient always remains fully visible during
therapy.
WARNING
 Ensure that cannulas are adequately fixed.
 Regularly check patient access.
 Venous lower limit should preferably be > 0 mmHg.

5.3.1 Monitoring the blood-side pressure limits

Venous return flow pressure (PV)

The venous return flow pressure (PV) is monitored by an automatically set limits
window. The limits window is set 10 seconds after the last activation of the blood
pump and is identified by markings on the bar showing the venous return flow
pressure.
The width and thresholds of the limits window are set in the service program by the
technical service.

 The venous lower limit value is automatically adjusted during treatment. This means
that the distance between the lower limit and the actual pressure decreases. This
compensates for the haematocrit increase generally caused by ultrafiltration. The
adjustment is carried out every 5 minutes and adds up to 2.5 mmHg at a time. The
minimum distance of 22.5 mmHg is, however, always maintained.

 Check venous lower pressure limit during dialysis. An optimal interval is approx.
35 mmHg between the lower pressure limit and the current value.

By changing the speed of the blood pump for a brief period it is possible to reposition
the limits window. In this connection it is spread to the in TSM adjusted size. This
means that an already adjusted lower limit value is put back to the in TSM adjusted
interval.

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Arterial entry pressure (PA)

The arterial entry pressure (PA, pressure between patient and blood pump) is
automatically monitored within set limits. The limits window is set 10 second after the
last activation of the blood pump.
An additional maximum lower limit value could be adjusted up to -400 mmHg in TSM.
These limits are active in the therapy phase and during final circulation.

When setting the limits window ensure that the upper limit is as negative as possible.

5
Blood-side entry pressure at the dialyser (PBE)
If a PBE pressure sensor is used, the blood-side entry pressure (1) at the dialyser is
controlled by its upper limit. The PBE monitoring function warns or signals a possible
blockage of the dialyser due to a kinked tube or increased clotting within the dialyser.
The PBE measurement allows the operator to monitor the formation of a secondary
membrane layer in the dialyser. A possible filter clotting might be avoided. The limits
can only be set via the Alarm limits screen at the beginning of the therapy.

Fig. 5-4 "Alarm limits" screen during therapy

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Additionally to the maximum PBE value (2), a so-called Delta (3) could be adjusted.
Delta represents a limiting value which lies above the average actual value of the PBE.
It serves as monitoring the accumulation of a secondary membrane. The average
actual value of the PBE is determined by the Dialog+ within the first five minutes after
starting the therapy and stored as an reference value in the SW. Changes of pressure
by variation of blood flow are automatically considered (e. g.: Average actual value of
PBE at 155 mmHg, plus Delta 150 mmHg, the outcome of this is a PBE limiting value
of 305 mmHg). Achieving this limiting value a yellow warning text appears.

Exeeding the limiting value a red alert text appears.

If the accumulation of a secondary membrane shall not be monitored, the Delta value
could be adjusted to the maximum PBE limiting value.
5
It is possible to use a blood tube system without PBE access. The machine realises the
absence of a pressure transducer during preparation. Monitoring PBE during therapy
is omitted.

5.3.2 Treatment at minimum UF rate

Treatment at minimum UF rate can be activated to achieve, for instance, an immediate

lowering of the set UF rate in case of falling blood pressure and unstable
circulation.

The therapy time still continues during treatment at the minimum UF rate. Where
necessary, adjust UF volume after a treatment at minimum UF rate.

Activate minimum UF rate

 Touch icon.
The treatment continues with the set minimum UF rate.
The dialysis machine will sound an acoustic signal every 10 minutes.

Deactivate minimum UF rate

 Touch icon again.
The treatment continues with or without UF compensation depending on the
setting.

UF compensation
Technical service can determine in the service program how treatment is to be
continued after a minimum UF rate phase.

UF compensation YES
After temporary treatment with minimum UF rate, the preselected UF volume will be
nearly reached by increasing the UF rate in the set UF time.

UF compensation NO
After temporary treatment at minimum UF rate, the preselected UF quantity will not
be reached in the preset UF time.

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5.3.3 Heparin bolus

 Touch icon.
A safety message will be displayed.
 Confirm heparin bolus by pressing Enter key on monitor.
The heparin bolus preset in the heparin parameters is activated.

Risk of blood loss due to blood clotting in case of insufficient anticoagulation!

5 WARNING
 In case of a heparin syringe pump failure, complete heparin bolus manually.

• The heparin bolus can be repeated.

• Technical service can program the dialysis machine in the service program in such
a way that a heparin bolus is automatically administered whenever blood is
detected at the red detector on the venous tube clamp. For this purpose, the
extracorporeal circulation should be heparinised.

5.3.4 Arterial bolus

Using the function “Arterial bolus” a defined volume of sodium chloride is infused
from a NaCl bag.

 Touch icon.
The set-up window for the arterial bolus is displayed.
 Enter bolus volume.

Legend
1 Start bolus
2 Bolus volume
3 Infused bolus quantity
4 Arterial infused volume
5 Total volume infused

Fig. 5-5 Set-up window for arterial bolus

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Fig. 5-6 Clamping off the arterial patient inlet

 Touch icon.
The blood pump stops automatically and a safety message appears on the screen.
 Connect bag with physiological saline solution to arterial infusion connector.
 Clamp off arterial bolus 1 if necessary.
 Confirm arterial bolus by pressing the Enter key  on monitor.
The arterial bolus is infused. The values can be monitored in the settings window.
Once the set quantity has been infused or the arterial bolus has been terminated by an
alarm, a window appears to confirm Bolus terminated.
 Remove clamp on patient inlet, clamp off infusion line and confirm by pressing the
Enter key  on monitor.
The window for the arterial bolus is closed and replaced by the therapy screen.

Risk of sodium imbalance and patient overload!

 In case of a blood pump failure during an arterial bolus or reinfusion,
complete bolus manually.
WARNING  In case of a prematurely closed venous clamp, complete arterial bolus via
hydrostatic infusion.

If the arterial bolus was terminated by an alarm, the entire bolus quantity will be
infused upon reactivation of the arterial bolus.

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5.3.5 Graphical representation of treatment parameters (trend)

 Touch icon.
A screen with the graphical representation icon appears.

 Touch icon.

5  Touch icon
The following screen is displayed.

Legend
1 Trend group
2 Activate pre-adjustment from
TSM
3 Edit a trend group
4 Safe and leave window
5 Safe not and leave window

Fig. 5-7 Trend groups

A standard of six groups with three parameters each is preset in the TSM.

How to edit individual trend groups is described in chapter 11.8.

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 Touch field of selected trend group.

The following screen is displayed.

Legend
1 Graphic representation of a
treatment parameter
2 Move reference time period
forwards
3 Move reference time period
backwards
4 Set time for reference period
5 List of all trends 5

Fig. 5-8 Graphic representation of treatment parameters

Treatment parameters at a defined point in time

There are two ways by which the treatment parameters can be called off at a defined
point in time:

1st option:
 Directly enter the time (4) in the Time window.

2nd option:
 Move the time reference line by using the icons << (2) or >> (3).

Call history of trend data

In addition to the actual therapy the last 20 therapies carried out with the machine
could be displayed.
 Touch field 5
The following screen is displayed.

IFU 38910273EN / Rev. 2.11.00 / December 2011 5-13

Initiating haemodialysis Dialog+

Legend
1 Actual therapy
2 All therapies, max. 20

Fig. 5-9 “Trend-History“ screen

 To open the graphic representation touch respective field.

The background of the Name field for the actual therapy is green, the background of
the stored therapies is displayed in yellow.

Patient names only appear if they are manually entered before therapy or if a
therapy card is used.

Observe local data protection opening trend data which are marked with patient
names.

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Dialog+ Initiating haemodialysis

5.3.6 Interrupting the haemodialysis (bypass)

 Touch icon.
The dialysis machine switches to the bypass mode. The haemodialysis is interrupted.
The signal lamps on the monitor switch to yellow. The icon changes its display.

 Touch icon again.

The bypass mode is terminated, the treatment is continued.

5
Depending on the settings in the service program, the change into the bypass mode
must also be confirmed by pressing the Enter key on monitor.

5.4 Completion of treatment

On completion of the treatment, an acoustic signal can be heard and the message
"Treatment time completed" is displayed, the signal lamps on the monitor switch to
yellow.
• The UF rate is set to 50 ml/h.
• The blood pump is still running.
• The time beyond the adjusted treatment time is shown instead of the remaining
time with a minus symbol in front. The graphics will be displayed in red.

5.4.1 Terminating treatment

 Touch icon.
The message "Terminating treatment" is displayed.
 Confirm termination of treatment by pressing the Enter key on monitor.

5.4.2 Continuing treatment

 Touch icon.
After entering new treatment parameters, the haemodialysis can be continued.

Risk of blood pressure drop or cramps for the patient by continuous

ultrafiltration!
CAUTION  Ensure that ultrafiltration will be stopped in appropriate time.

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Initiating haemodialysis Dialog+

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Dialog+ End of haemodialysis therapy

Table of contents

6 End of haemodialysis therapy ............................................................ 6-3

IFU 38910273EN / Rev. 2.11.00 / December 2011 6-1

End of haemodialysis therapy Dialog+

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Dialog+ End of haemodialysis therapy

6 End of haemodialysis therapy

6.1 Reinfusion

During the reinfusion phase the limits windows are set to their maximum values. The
reinfusion phase, therefore, demands particular care.

After confirming End of Therapy, the following screen appears:

Fig. 6-1 "Confirm reinfusion" screen

Danger of air embolism in case of reinfusion with air!

 Only carry out reinfusion with fluids.
WARNING

 Remove arterial connection from patient.

 Connect arterial line to infusion bag containing physiological saline solution.
 Confirm arterial disconnection by pressing the Enter key on monitor.

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End of haemodialysis therapy Dialog+

The blood pump starts the reinfusion. The reinfusion screen appears.

Fig. 6-2 "Reinfusion" screen

The Dialysis machine monitors the reinfusion volume and reinfuses until the red
detector (RDV) detects the physiological saline solution. The blood pump stops.
 To continue reinfusion, start blood pump by pressing START/STOP button on
monitor.
The blood pump stops automatically after 400 ml have been reinfused or when a
reinfusion time of 5 minutes has elapsed.
The query "Continue reinfusion?" appears on the screen.
 To continue the reinfusion process, confirm by pressing the Enter key on monitor.
The dialysis machine will carry out reinfusion of another 400 ml, or reinfusion for
5 minutes.
 Disconnect venous patient connection.

The screen "Confirm reinfusion" (Fig. 6-1) appears only if configured accordingly in
the service program. Otherwise, reinfusion must be called up by pressing icon 1
(Fig. 6-2).

The user is obliged to check for correct setting of the levels in the chambers.

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Dialog+ End of haemodialysis therapy

6.2 Emptying the dialyser

 Touch icon.
An information window describing the next steps appears.
 Follow the instructions on screen and confirm by pressing the Enter key  on the
monitor.
The dialyser is emptied.
 Once the dialyser has been emptied, connect the second dialyser coupling to the
rinsing bridge.
 Remove from the dialysis machine the dialyser and blood tube system and dispose
of both.
The dialysis machine must be disinfected, see chapter 7.

6
Once "Empty dialyser" has been confirmed, the blood pump cannot be started
anymore!

6.3 Emptying the cartridge after dialysis

The cartridge can be emptied before or after emptying the dialyser.

Emptying the cartridge before the dialyser is emptied

 Leave both couplings on the dialyser.
 Touch icon and confirm by pressing the Enter key on the monitor.
The cartridge is emptied automatically.

Emptying cartridge after the dialyser is emptied

 Connect both couplings to the rinsing bridge.
 Touch icon and confirm by pressing the Enter key on the monitor.
The cartridge is emptied automatically.

The functions ”Empty dialyser” and ”Empty cartridge” can be started simultaneously.
However, they are carried out one after the other.
The cartridge is emptied as long as both couplings are connected to the dialyser or
the rinsing bridge.
If the blue coupling is connected to the rinsing bridge, the dialyser is emptied.

IFU 38910273EN / Rev. 2.11.00 / December 2011 6-5

End of haemodialysis therapy Dialog+

6.4 Overview of the therapy carried out

 Touch icon.
An overview with the actual values appears for the following values:
• Treated blood volume
• UF volume of haemodialysis
• UF volume of sequential phases
• Heparin volume
• Substitution volume (only for HDF/HDF online)
• Profile, if set
More parameters can be displayed by actuating the respective icons.

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Dialog+ Disinfection

Table of contents

7 Disinfection .......................................................................................... 7-3

7.1 Procedure and disinfectants................................................................ 7-3
7.2 Preparing for disinfection ................................................................... 7-4
7.2.1 Positioning the disinfectant container ...............................................7-4
7.2.2 Selecting the disinfection program .....................................................7-5
7.3 Automatic switch-off and restarting................................................. 7-6
7.3.1 Automatic switch-off after disinfection ............................................7-6
7.3.2 Automatic switch-off and restarting ..................................................7-6
7.4 Chemical disinfection........................................................................... 7-8
7.5 Short chemical disinfection ................................................................ 7-9
7.6 Thermal disinfection ............................................................................ 7-9
7
7.7 Disinfection of incoming water from water supply........................ 7-10
7.7.1 Chemical disinfection with disinfecting solution from
central water supply ............................................................................. 7-11
7.7.2 Automatic chemical disinfection with disinfectant from
central water supply ............................................................................. 7-12
7.7.3 Thermal disinfection with hot permeate from central
water supply ............................................................................................ 7-14
7.7.4 Rinsing the permeate inlet.................................................................. 7-15
7.8 Checking for disinfectant residues................................................... 7-16
7.9 Decalcification.................................................................................... 7-17
7.9.1 Automatic descaling ............................................................................. 7-17
7.10 Terminating disinfection.................................................................... 7-19
7.11 Disposal of old dialysis appliance ..................................................... 7-20

IFU 38910273EN / Rev. 2.11.00 / December 2011 7-1

Disinfection Dialog+

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7 Disinfection

7.1 Procedure and disinfectants

For cleaning the housing and monitor, see section 12.1.

In the disinfection mode, the following programs are available:

Disinfection program Duration of disinfection Notes

Chemical disinfection approx. 35–55 min (depending

on disinfectant) —

Short chemical disinfection approx. 25–45 min (depending Reduced disinfection effectiveness!
Also: decalcification with citric acid 50 % on disinfectant) Also for decalcification with citric acid 50 %, particularly
following a bicarbonate dialysis.

Thermal disinfection approx. 40 min Use only in exceptional cases.

Depending on water quality, carry out chemical disinfection 7
at regular intervals.
After a bicarbonate dialysis, first decalcify with citric acid
50 %.

Chemical disinfection with disinfection adjustable Depending on the installed water treatment system
solution from central water supply With the automatic method, the disinfection solution does
manually or automatically not contact the optional DF filter.
Thermal disinfection with hot permeate approx. 30 min Depending on the installed water treatment system
from central water supply

Rinse permeate inlet 2 min up to 10:00 h adjustable —

These procedures can be activated or deactivated to allow disinfection tailored to the

individual situation.
Beyond that, the following options can be activated or deactivated:
• Disinfection necessary after every dialysis
• Termination of disinfection procedure possible/disabled
• Automatic disinfection

Settings in the service program such as intake volume, disinfection time, temperature
or rinsing time can only be configurated by Technical Service!

Recommended disinfectants
For disinfection we recommend citric acid 50 % or TIUTOL® KF.

IFU 38910273EN / Rev. 2.11.00 / December 2011 7-3

Disinfection Dialog+

7.2 Preparing for disinfection

Scalding or chemical burns hazard for users if disinfectants escape from

connection points!
 During disinfection:
WARNING Do not remove dialyser couplings.
Do not pull out concentrate suction rods.

Chemical burns hazard for users if concentrated disinfectants are sprayed or

spilled!
 Take appropriate measures, e.g. wear protective clothing, goggles and face
WARNING mask.
7  Rinse off splashes on skin and clothing with clear water.

Machine damage by unknown ingredients of disinfectant!

 Ensure that the disinfectant is pure active chlorine (like TIUTOL® KF).
 Ensure that the concentration of available chlorine in disinfectant is
WARNING 3.9 g/100 g (like in TIUTOL® KF).
Otherwise, B. Braun won’t assume any liability on the intactness of the device.

 Ensure that sufficient suitable disinfectant is connected.

– If necessary, change disinfectant container.
– Take into consideration that a disinfection cycle may be started automatically at
a later time.

7.2.1 Positioning the disinfectant container

 Insert disinfectant container into fixing at the rear of dialysis machine.

 Connect disinfectant line to the disinfectant connection on the rinsing bridge.
 Ensure that the disinfectant container is not positioned higher than the rinsing
bridge.

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Dialog+ Disinfection

7.2.2 Selecting the disinfection program

Selecting the disinfection program before the dialysis

Fig. 7-1 Program selection

 Touch field 1.
The screen listing the different disinfection programs appears.

Legend
1 Select disinfectant
2 Thermal disinfection
3 Chemical disinfection
4 Short chemical disinfection
5 Rinse permeate inlet
6 Chemical disinfection with
disinfection solution from
central water supply
7 Thermal disinfection with hot
permeate

Fig. 7-2 Selection of disinfection program

 Select disinfectant in field 1.

 Select disinfection program through icons 2 to 7.

IFU 38910273EN / Rev. 2.11.00 / December 2011 7-5

Disinfection Dialog+

Selecting the disinfection program after dialysis

 Touch icon.
The screen with the different disinfection programs is displayed, see Figure 7-2.
 Select disinfectant in field 1.
 Select disinfection program through icons 2 to 7.

7.3 Automatic switch-off and restarting

The following disinfection settings are available:

• Automatic switch-off after disinfection
• Automatic switch-off and restarting
• Weekly disinfection program, see section 11.2

7.3.1 Automatic switch-off after disinfection

If the automatic switch-off function is activated, the machine will switch-off

7 automatically after each manually started disinfection. A time-out can be set by the
user. Please see chapter 11.1.

7.3.2 Automatic switch-off and restarting

The use of water detectors is recommended for detecting potential leaks during
unsupervised operation.

This function allows switching off the dialysis machine automatically after
disinfection. The dialysis machine is switched on automatically at the specified time
and prepares the next dialysis.

 Touch icon.
A screen showing the settings of the weekly disinfection program appears:

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Dialog+ Disinfection

Fig. 7-3 Automatic switch-on

 Set the parameters:

– Start time with field 2
– Disinfection program with field 4
– Date with field 5
– Disinfectant with field 6
 Activate settings with field 7.
An information window about the automatic switch-off will be displayed.
In case of a night disinfection 3 (moon), the dialysis machine switches off
automatically on completion of the disinfection cycle.
In case of a daytime disinfection 1 (sun), the machine switches to ”Preparation” after
the disinfection cycle, or it remains in rinse-out mode depending on the settings
performed in the service program by technical service.
 Confirm information by pressing the Enter key .
The dialysis machine switches off after the disinfection cycle. At the set time, the
dialysis machine switches on again and carries out the set disinfection.

Leave mains switch of dialysis machine switched on.

Ensure that sufficient disinfectant is connected.
Disinfection must in each case be reactivated for the following day.

IFU 38910273EN / Rev. 2.11.00 / December 2011 7-7

Disinfection Dialog+

7.4 Chemical disinfection

Damage to dialysis fluid filter system!

 Where dialysis fluid filters are used, only use the disinfectants specified in the
CAUTION instructions for use of the dialysis fluid filter for disinfection.

 Select disinfectant, e.g. “citric acid 50 %”.

 Touch icon.
The sequence of the disinfection program is displayed in field 1.

Fig. 7-4 ”Chemical disinfection” screen

Sequence
After activation, the chemical disinfection is carried out automatically as follows:
• Automatic rinse-out
• Aspiration of disinfectant and start of heating cycle
• Disinfection phase: Exposure and circulation
• Rinse-out phase

End disinfection
 Check if system is free of disinfectant, see section 7.8.

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Dialog+ Disinfection

7.5 Short chemical disinfection

Short chemical disinfection is intended only for decalcification and can be carried out
only with citric acid!

 Activate icon.
The short chemical disinfection is carried out.
 Check if system is free of disinfectant, see section 7.8.

7.6 Thermal disinfection

Use thermal disinfection only in exceptional cases as its germ-reducing effect is not
sufficient for regular application.
Thermal disinfection is not suitable after bicarbonate dialysis as the dialysis machine 7
needs to be decalcified.
After a bicarbonate dialysis, chemical disinfection with citric acid 50 % is
recommended.

 Touch icon.
The thermal disinfection is started.
The progress of disinfection cycle is displayed on the screen.

Fig. 7-5 ”Thermal disinfection” screen

IFU 38910273EN / Rev. 2.11.00 / December 2011 7-9

Disinfection Dialog+

After activation, thermal disinfection is carried out as follows:

• Automatic rinse-out
• Heating to at least 85 °C
• Disinfection: Exposure and circulation
• Cooling down

7.7 Disinfection of incoming water from water supply

The dialysis machine offers the option of chemical or thermal disinfection of incoming
water supplied through the water treatment system. The water treatment system must
be suitable for this procedure.

The temperature monitoring during this disinfection program refers to the dialysis
machine and not to the supply line.
Removal of fluid from the central water supply influences the temperature.
7 The use of water detectors is recommended for detecting potential leaks during
unsupervised operation.
For information about the disinfection of the water treatment system, refer to the
operating instructions for water treatment system.

Risk of poisoning the patient with disinfectants left in the water supply!
 During central disinfection install warning sign on dialysis machine, e.g.
”Disinfectant in water inlet!”
 Reuse dialysis machine for dialysis operation only after the water inlet line
WARNING has been adequately rinsed.
 Only connect inlet tubes to central water supply after they have been cleared
of disinfectant.

Contamination risk to patients if machine is not adequately disinfected.

Disinfection of water inlet system is no substitute for disinfection of the
machine.
WARNING  Disinfect the dialysis machine separately after disinfection of the water
supply line.

Risk of damage to the machine due to material changes caused by unsuitable

disinfectants!
CAUTION  Only use agents suitable for Dialog+ for disinfecting the water inlet line.

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Dialog+ Disinfection

7.7.1 Chemical disinfection with disinfecting solution from central water

supply

During chemical disinfection of the water inlet, the disinfecting solution is taken from
the central water supply and pumped into the dialysis machine.
 Touch icon.
The following screen appears:

Legend
1 Set flow rate for inlet
disinfection
2 Set duration for disinfection
of the inlet line
3 Set flow rate for rinse-out
4 Set duration for disinfection
of the inlet line 7

Fig. 7-6 ”Disinfection” screen

 Set the parameters:

– Inlet flow in field 1
– Inlet time in field 2
– Rinse-out flow in field 3
– Rinse-out time in field 4

If the central water supply contains disinfectant:

 Touch icon.
Inlet supply is started and stopped after the preset time.

Once all disinfectant has been rinsed out of the central water supply:
 Touch icon.
Rinsing of the dialysis machine supply line is started and stopped after the preset
time.
 Check supply line and dialysis machine for disinfectants.

IFU 38910273EN / Rev. 2.11.00 / December 2011 7-11

Disinfection Dialog+

7.7.2 Automatic chemical disinfection with disinfectant from central water

supply

This disinfection method should only be performed by staff who are also trained for
RO equipment.
Due to technical defects, disinfectant or water from central water supply could leak
over the dialysis machine. The use of humidity sensor is recommended.

During the automatic chemical disinfection of the water branch the disinfectant
solution is removed from the central water supply into the dialysis machine. With this
method certain valve positions prevent contact of the disinfectant with the DF-filter.

 Select disinfection screen.

 Touch icon.
7 The following screen appears.

Legend
1 Day disinfection
2 Set time
3 Night disinfection
4 Select disinfection programm
5 Set date
6 Select disinfectant
7 Activate week progamm

Fig. 7-7 ”Disinfection” screen

 Touch button for disinfection method (4, Fig. 7-7).

 Choose „Water inlet chemical“, confirm with O.K.
 Set switch ON time (2, Fig. 7-7).
 Touch button “Activate” (7).
A warning window for the automatically switching OFF appears. The dialysis
machine switches OFF after disinfection. At the preset time the machine will
switch ON again and execute the chosen disinfection.

7-12 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Disinfection

Keep mains switch ON.

Assure that there will be enough disinfectant with the right concentration available
in central water supply. Otherwise, the disinfection effect might be reduced.

The following screen appears when switching ON:

Fig. 7-8 Screen “Disinfection”

If the inlet volume (1) is reached, the dialysis machine deactivates itself. After end of
the adjusted residence time (2), the machine reactivates and starts rinse phase with
adjusted parameters (3 and 4).
The service technician can preset the machine in TSM so that it will not reactivate
itself. The dwell time ends and the rinse phase starts if the machine is switched ON
manually. If disinfection parameters are put in as night disinfection, the machine
switches OFF after rinsing phase (see chapter 7.3).

Risk of poisoning the patient with disinfectants left in the dialysis machine!
 During central disinfection install warning sign on dialysis machine, e.g.
”Disinfectant in dialysis machine!”
 Make sure that disinfectant-free water will be available at the beginning of
rinse phase.
 Only use the machine for therapy after sufficient rinsing.
WARNING
 Check if the dialysis machine is disinfectant-free.
 Only switch ON the machine if the RO equipment is switched ON. If the mains
pressure is too low, disinfectant could reach from the inlet into the central
water supply line.

IFU 38910273EN / Rev. 2.11.00 / December 2011 7-13

Disinfection Dialog+

7.7.3 Thermal disinfection with hot permeate from central water supply

During this disinfection program, hot permeate is taken from the central water supply
into the dialysis machine. If necessary, the permeate is heated up to the temperature
which is required for thermal disinfection of the dialysis machine.

 Touch icon.
The following screen appears and the program starts.

Fig. 7-9 Screen “central thermal disinfection“

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Dialog+ Disinfection

7.7.4 Rinsing the permeate inlet

 Ensure that the dialysis machine is switched on and connected to the central water
supply.
 Touch icon.
The following screen appears and the program is started.

Fig. 7-10 ”Rinse permeate inlet” screen

IFU 38910273EN / Rev. 2.11.00 / December 2011 7-15

Disinfection Dialog+

7.8 Checking for disinfectant residues

Risk of poisoning the patient with disinfectant residues left in the machine!
 After using disinfectants, check for any disinfectant residues on the dialyser
WARNING couplings and on the discharge outlet!

If citric acid 50 % was used as disinfectant, a check for disinfectant residues is not
necessary.

The following information window appears on the screen after the set rinsing time:

Fig. 7-11 Information window ”Disinfectant residue check”

The following indicators can be used to check that the system is free from
disinfectant:

Disinfectant Disinfectant residue check

Citric acid 50 % No check required

TIUTOL® KF Potassium iodide starch paper or pH determination

with phenolphthalein as indicator

If the dialysis machine still contains some disinfectant:

 Continue rinsing of dialysis machine and repeat indicator test.

7-16 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Disinfection

If dialysis machine is free from disinfectant:

 Press Enter key on monitor.

 Touch icon.
The dialysis machine moves to program selection.
Depending on configuration, the dialysis machine either switches to the Preparation
screen or remains in the Rinse-out screen at the end of the rinse-out time. However,
the window for confirming that the system is free from disinfectant remains active
until it is confirmed by pressing the Enter key on monitor.

7.9 Decalcification

When using citric acid 50 % for disinfection, decalcification of the dialysis machine
is not required.
When using alkaline disinfectants, a decalcification with citric acid 50 % must first
be carried out. 7

7.9.1 Automatic descaling

Effective descaling of the DF filter is influenced by the preset contact time and the
temperature used during the cleaning cycle. Dialysis therapies using higher
concentrations of bicarbonate may require longer contact time and higher
temperature.

There may be a risk of uncontrolled UF withdrawal from patient due to a

calcified dialysis fluid filter.
 To prevent this, perform decalcification with citric acid 50% after each
treatment.
WARNING
 Alternatively, the automatic descaling function can be performed after each
treatment if activated in TSM.

Risk of blood contamination.

 Use the same type of acid concentrate as used in the previous treatment.
WARNING

The automatic descaling function can be enabled in TSM. Instead of citric acid, acid
concentrate used for treatment is drawn in from the machine in high concentration to
decalcify the DF Filter between two bicarbonate therapies. It does not replace
disinfection.

Automatic descaling is required if the machine is equipped with the option DF filter.

IFU 38910273EN / Rev. 2.11.00 / December 2011 7-17

Disinfection Dialog+

 After the patient is disconnected from the machine, empty the dialyzer as usual.
 Connect the dialyzer couplings to the rinsing bridge.

The bicarbonate cartridge may be left in the holder during the process.
The bicarbonate concentrate coupling may be left connected to the concentrate
source during the process.

 Ensure connection of acid concentrate coupling to concentrate source.

 The descaling process will start automatically after End of Therapy without any
method selection if the user enters into Disinfection.

Automatic descaling only starts after a bicarbonate dialysis.

Automatic descaling cannot be started manually.

7 The following screen appears and the process is started:

Fig. 7-12 ”Descaling” screen – Acid drawing up

After acid is drawn up, the machine enters into acid rinse out.
The following screen appears:

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Dialog+ Disinfection

7
Fig. 7-13 ”Descaling” screen – Acid rinse out

As soon as acid rinse out is completed, the machine enters into Preparation and starts
the preparation process if the “Automatic Preparation Start after Disinfection“ has
been enabled in TSM.

If “Automatic Preparation Start after Disinfection” is disabled in TSM, the machine

enters into Disinfection and starts disinfection rinsing automatically. In this case, all
couplings must be on the rinsing bridges and the cartridge holder must be closed.

Automatic descaling can be interrupted in any phase of the process. The machine will
go to Disinfection main screen and the acid rinse out will be carried out. Afterwards,
disinfection rinsing will start automatically.

7.10 Terminating disinfection

If the dialysis machine was configured in the service program in such a way that
disinfection can be terminated, the disinfection program can be terminated at any
time.

 Touch icon.
An information window appears.

If disinfectant has already been drawn in, the termination of the program is followed
by a rinse-out phase (e.g. 5 minutes when using citric acid 50 %, or 20 minutes when
using TIUTOL® KF).
If the settings ”Disinfection after every dialysis” and ”Termination of disinfection”
have been configured, a full disinfection must be carried out prior to the next
dialysis.

IFU 38910273EN / Rev. 2.11.00 / December 2011 7-19

Disinfection Dialog+

 To terminate the disinfection, press Enter key  on monitor.

The ”Select disinfection program” screen is displayed, see Fig. 7-2. You can select a
different disinfection program.

7.11 Disposal of old dialysis appliance

The Dialysis machine has to be disinfected according to regulations before disposal.

For information about the disposal see chapter 1.7.

7-20 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ HDF-online/HF-online

Table of contents

8 HDF-online/HF-online......................................................................... 8-3
8.1 Preparing for haemodiafiltration/haemofiltration ........................... 8-4
8.1.1 Calling up haemodiafiltration/haemofiltration ................................8-4
8.1.2 Connecting the concentrate ..................................................................8-4
8.1.3 Entering the substitution parameters .................................................8-5
8.1.4 Inserting the tube system.......................................................................8-7
8.1.5 Filling and rinsing the tube system with substitution
solution from the online system...........................................................8-7
8.1.6 Inspecting the tube system................................................................. 8-10
8.2 Preparing for standard haemodialysis with online fluid ................ 8-10
8.3 Carry out haemodiafiltration/haemofiltration................................ 8-11
8.3.1 Connect patient and start
haemodiafiltration/haemofiltration.................................................. 8-11
8.3.2 During haemodiafiltration/haemofiltration.................................... 8-13
8.4 Finish haemodiafiltration/haemofiltration...................................... 8-15
8
8.4.1 Reinfusion with substitution solution.............................................. 8-15
8.4.2 Emptying the dialyser ........................................................................... 8-17
8.5 Disinfection ......................................................................................... 8-17
8.5.1 Regular disinfection .............................................................................. 8-17
8.5.2 Displaying the online filter data........................................................ 8-17
8.5.3 Changing the online filter ................................................................... 8-18
8.5.4 Sampling of substitution fluid ........................................................... 8-21

IFU 38910273EN / Rev. 2.11.00 / December 2011 8-1

HDF-online/HF-online Dialog+

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Dialog+ HDF-online/HF-online

8 HDF-online/HF-online

In addition to haemodialysis, Dialog+ HDF-online also offers the therapy types

haemodiafiltration and heamofiltration, in which the substitution solution is prepared
online by the dialysis machine.
In this chapter, only those steps that differ from the haemodialysis procedure are
described in detail.
The operator is responsible for the surveillance of the hygienical soundness of the
dialysis machine and the produced dialysis- and substitution fluid.
Pay regard to present regional regulations if necessary.

Risk to the patient due to contamination and pyrogenic reaction caused by

unsuitable filter membranes!
 Only B. Braun Diacap Ultra filters may be used for HDF/HF therapy.
WARNING  Concerning the use of other filter types please contact B. Braun Avitum AG.
 Always observe the instructions for use provided with the filters.
8
Risk to the patient due to contamination and pyrogenic reaction caused by germ
growth in the permeate or in the dialysis fluid!
 Execute regularly microbiological reviews of permeate and dialysis
WARNING
fluid/substitution fluid.

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HDF-online/HF-online Dialog+

8.1 Preparing for haemodiafiltration/haemofiltration

Risk to the patient due to contamination and pyrogenic reaction caused by germ
growth during extended idle times for the system between treatments.
 Disinfect the dialysis device before a new treatment especially after
WARNING
extended idle times.

8.1.1 Calling up haemodiafiltration/haemofiltration

Following switch-on and termination of disinfection the Dialog+ HDF-online dialysis

machine displays the following main screen:

b
Fig. 8-1 Main screen ”HD/HDF/HF”

 Touch field 1.
The first preparation screen for HD/HDF/HF is displayed. The dialysis machine starts an
automatic test sequence.

8.1.2 Connecting the concentrate

See section 4.

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Dialog+ HDF-online/HF-online

8.1.3 Entering the substitution parameters

 Touch icon.
A screen showing the substitution parameters is displayed.

Fig. 8-2 ”Substitution parameters HDF” screen

 For haemodiafiltration touch field HDF,

for haemofiltration touch field HF.
The online system for substitution is activated now.

In this way the HDF/HF mode can be activated even during a running haemodialysis.
However, in this case the substitution line will not be tested. Therefore, special care
must be taken when connecting the line. Therefore, pay special attention to ensure
that the direction of the pump operation corresponds with the desired flow direction
of the substitution solution!

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HDF-online/HF-online Dialog+

 Set the treatment parameters for HDF/HF.

Item Text Value range Description

1 Inf. bolus Activates administration of

– an infusion bolus during
therapy.

2 Nominal 50-250 ml
bolus volume –

3 Total of inf. volume Total bolus volume

– administered, including
arterial bolus if applicable.

4 Predilution activated/deactivated When activated, the

UF/blood flow ratio
monitoring function is
turned off.

5 UF/blood Displays the ratio between

Flow ratio blood flow (per minute) and
8 – total UF rate (per minute).

6 Blood Flow Displays the current blood

– flow rate.

7 Dialysate 500-800 ml/min This field is displayed only if

Flow Preset to 600 ml/min for HDF was selected.
postdilution For HF, the value is fixed to
Preset to 700 ml/min for 500 ml/min.
predilution

8 Substitution max. 192 l Substitution flow and

Volume substitution volume are
interdependent. When one of
9 Substitution 20-400 ml/min the parameters is changed,
Flow the other is adjusted
automatically.

10 Mode HDF or HF Activates HDF or HF mode.

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Dialog+ HDF-online/HF-online

Fig. 8-3 Tube system for HDF/HF therapy, connected for online rinsing

8.1.5 Filling and rinsing the tube system with substitution solution from the
online system

The Dialog+ HDF-online dialysis machine allows filling and rinsing the blood tube
system and the dialyser with the substitution solution prepared by the machine. The
rinsing liquid is taken from the machine and recycled back to it.

The dialysis solution is only available if all DF tests are passed and no DF alarm is due
to be dealt with.

IFU 38910273EN / Rev. 2.11.00 / December 2011 8-7

HDF-online/HF-online Dialog+

The following information window is displayed during the automatic test:

8
Fig. 8-4 Information window for connection

 Take dialyser connections from rinsing bridge and connect to dialyser. Observe
colour-coding.
 Turn dialyser with blue connection facing upward.
 Open substitution port outlet 2 and connect substitution line.
 For postdilution, connect the other end of the substitution line to the venous
bubble catcher. For predilution, connect the other end of the substitution line with
the additional adapter upstream from the dialyser.
 Connect arterial patient connection to the Luer-lock connector of the substitution
line between substitution port outlet and substitution pump.
 Insert pump segment of the substitution line into the venous blood pump.
 Connect venous patient connection to substitution port reflow 1.
 Confirm correct connection of dialyser and substitution line by pressing Enter key
on the monitor.
The blood tube system and the substitution line will be filled with substitution
solution.

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Dialog+ HDF-online/HF-online

After approx. 10 seconds the following information window appears:

8
Fig. 8-5 Information window for level adjustment

 Set level as follows:

– Fill chamber in front of the blood-side dialyser inlet to about half full.
– Fill venous drip chamber up to approx. 1 cm from the top.
 Make sure the blood line and the dialyser are completely filled with solution before
confirming the window and turning the dialyser.
 Confirm correct settings by pressing the Enter key on the monitor.
The dialysis machine will test the blood tube system and the substitution lines.
As soon as the automatic test is passed successfully, the rinsing program starts
running with the set rinsing parameters.

The dialysis machine can also be conditioned with rinsing solution from bags, see
section 4.

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HDF-online/HF-online Dialog+

8.1.6 Inspecting the tube system

Risk to patient due to uncontrolled ultrafiltration caused by leaks in the

substitution line and at its connectors!
 Inspect substitution line and its connectors for external leaks prior to every
treatment.
DANGER
 Inspect substitution line and its connectors for leaks at regular intervals
during the complete therapy.

8.2 Preparing for standard haemodialysis with online fluid

It is possible to use the online fluid to prime for a standard HD treatment without
using a substitution line.

 Set-up standard double-needle blood line system as usual without connecting the
arterial and venous patient Luer-Lock connectors.
8  In Program Selection, select "HD/HDF/HF".
The confirmation window (figure 8-4) appears.
 Take dialyser connections from rinsing bridge and connect to dialyser. Observe
colour-coding.
 Turn dialyser with blue connection facing downward.
 Connect the arterial line to the substitution port outlet (white).
 Connect the venous line to the substitution port reflow (blue).
 Confirm correct connection of dialyser by pressing the Enter key on the monitor.

The blood line is filled with saline from the online port. Follow description on page
8-9.

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Dialog+ HDF-online/HF-online

Legend
1 Venous pressure sensor
2 Arterial pressure sensor
3 Arterial blood pump
4 Heparin pump
5 Pressure sensor dialyser input
pressure
6 Dialyser
7 Online substitution pump
(not used)
8 Substitution port outlet
9 Substitution port reflow
10 Venous tube clamp
11 Safety air detector/red sensor

Fig. 8-6 Tube system for HD with online fluid

8.3 Carry out haemodiafiltration/haemofiltration

8.3.1 Connect patient and start haemodiafiltration/haemofiltration

Risk to patient due to blood loss caused by wrong positioning of the substitution
line!
 Inspect the substitution line for its flow direction prior to every treatment.
 Position substitution line always prior to selftest.
DANGER
 It is recommended to use only substitution lines produced by B. Braun.
 Other systems than those produced by B. Braun must have a non-return valve.

As soon as the patient data have been confirmed, the therapy screen is displayed with
a window requesting "Connect patient".

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HDF-online/HF-online Dialog+

Fig. 8-7
8 Therapy screen ”HDF/HF”

Poisoning danger for patient if substitution port contains any disinfectant

residue!
 After the use of disinfectants, check to make sure that the substitution port
WARNING
and the outlet are free from disinfectants!

Risk of infection due to germ contamination of the substitution port!

 Observe hygiene aspects when connecting the arterial and venous lines.
 Do not touch the connectors with your bare hands.
WARNING
 If necessary, disinfect with a suitable disinfectant.

Risk of infection due to germ contamination of the connecting lines!

 Observe hygiene aspects when connecting the arterial and venous lines.
WARNING  Seal the connector on the substitution line with a suitable stopper.

 Remove the arterial line from the substitution line and connect it to the patient.
 Start blood pump by pressing START/STOP button on monitor.
The blood pump operates automatically at the preset rate.
 Fill blood tube system with blood.
The blood pump stops automatically if blood is detected at the red sensor
downstream from the safety air detector.
 Remove the venous line from substitution port reflow and connect it to the patient.
 Close the substitution port.

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Dialog+ HDF-online/HF-online

 Start blood pump by pressing START/STOP button on monitor.

 Touch icon.
The dialysis machine switches to main connection and the
haemodiafiltration/haemofiltration is started.
The signal lamp on the monitor lights up green.

If the blood pumps are stopped manually or deactivated, the patient connection will
be interrupted (venous pressure rises).

 Press the icon to continue patient connection after interruption.

8.3.2 During haemodiafiltration/haemofiltration

In the same way as during haemodialysis, the following additional functions are
available during haemodiafiltration/haemofiltration:
• Treatment at minimum UF rate
• Administration of a heparin bolus
• Administration of an arterial bolus 8
• Halting the haemodiafiltration/haemofiltration
Administering an infusion bolus is also possible.

Infusion bolus

Loss of blood pressure because of missing volume for the stabilisation of the
circulation if the DF-flow is interrupted by a technical defect or by switching
into bypass.
CAUTION
 Keep an NaCl-bag ready for infusion or reinfusion.

 Touch icon.
The substitution parameters and infusion bolus screen is displayed.

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HDF-online/HF-online Dialog+

Fig. 8-8
8 ”Substitution parameters HDF” screen

 Adjust bolus volume if necessary. To end this, touch field bolus Volume and enter
new setting.
 Touch field Inf. bolus and acknowledge information by pressing on the monitor.
The infusion of the bolus is started. The blood pump operates at 100 ml/min, the
substitution pump at 200 ml/min. The infused volume is added up in the field Total of
Inf.volume.
As soon as the bolus has been administered completely, blood flow and substitution
flow automatically reset to their original values.

Halting the bolus administration

 Touch field Inf. bolus again during bolus administration.
Bolus administration is stopped.

The bolus volume is not added to the ultrafiltration volume automatically so that it
remains with the patient.

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Dialog+ HDF-online/HF-online

8.4 Finish haemodiafiltration/haemofiltration

At the end of the therapy an acoustic signal is sounded. The message ”Therapy time
over” is displayed. The dialysis machine reduces the UF rate to 50 ml/h.

 Touch icon.
A query window ”End of Therapy” pops up.
 Confirm end of treatment by pressing Enter key on the monitor.
The treatment is finished.

8.4.1 Reinfusion with substitution solution

During the reinfusion phase, the limit windows are set to their maximum values. The
reinfusion phase, therefore, demands particular care.

 Touch icon.
The following screen is displayed:

Fig. 8-9 ”Confirm reinfusion” screen

The ”Confirm reinfusion” screen (Fig. 8-9) appears only if configured accordingly in
the service program. Otherwise, reinfusion must be called up by pressing icon 1
(Fig. 8-10).

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HDF-online/HF-online Dialog+

Risk of infection due to germ contamination of the connecting lines!

 Observe hygienic aspects when connecting the arterial and venous lines.
WARNING  If necessary, disinfect with a suitable disinfectant.

In case a substitution line is used:

 Remove arterial connection from patient.
 Connect the arterial line to the rinsing connector of the substitution line between
substitution port and substitution pump.
 Open the clamp at the branch-off of the substitution line.

In case a standard HD treatment is completed and no substitution line is used:

 Fill the adapter line manually with saline.
 Connect adapter line to the substitution port outlet (see figure 8-3).
 Connect arterial line to the adapter.
 Confirm reinfusion phase by pressing Enter key on the monitor. The blood pump is
started.

Fig. 8-10 "End of Therapy" screen with reinfusion activated

The dialysis machine monitors the reinfusion volume and reinfuses until the red
detector recognises a preset dilution level of the blood. The blood pump stops.
 To continue reinfusion, press START/STOP button on the monitor.
The blood pump also stops automatically after 400 ml have been reinfused or once
a reinfusion time of 5 minutes has been achieved.
 Disconnect venous patient connection.

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Dialog+ HDF-online/HF-online

It is also possible to connect the arterial line directly to the port outlet without an
adapter line. A long disinfection is mandatory directly after this procedure.

Risk to patient due to cross contamination.

 Perform a long machine disinfection directly after End of Therapy in order
CAUTION to clean and disinfect the online ports correctly.

8.4.2 Emptying the dialyser

See section 6.2.

8.5 Disinfection

8.5.1 Regular disinfection

The regular disinfection after a dialysis and in the morning prior to the first dialysis is 8
described in chapter 7.

Changes to the material characteristics of the housing, encapsulation and

capillaries of the filter due to unsuitable disinfectants!
Endangering of patient! Dialyser is no longer safe to operate!
WARNING  Only use suitable disinfectants.
 Check information supplied with filter.

Scalding or alkali burn risk to users due to disinfectant solution escaping from
the substitution port or the filter holders!
The substitution connection and the filter holder heat up during disinfection.
WARNING  Do not open the substitution port or the filter holder during disinfection.
 Make sure that the substitution port is closed correctly.

8.5.2 Displaying the online filter data

 Touch icon.
The remaining operating time and the number of dialyses performed are displayed.

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HDF-online/HF-online Dialog+

8.5.3 Changing the online filter

The online filters must be changed at the latest when the following information
window pops up on the screen:

Fig. 8-11 Information window ”Filter change”

Contamination and pyrogenic reaction risk to patient due to infusion of

contaminated fluid in case of a ruptured HDF/DF filter!
 The HDF/DF filters are designed for regular use. Avoid extended idle times
without disinfection (according to the hygiene plan of the dialysis centre).
WARNING
 Do not use the filters after the filter service life has expired because,
otherwise, the required quality of substitution solution cannot be ensured.

We recommend disinfection with Tiutol® KF prior to changing the dialysis fluid

filters.

 Touch icon.
The selection menu appears.

 Touch icon.
The following window appears:

8-18 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ HDF-online/HF-online

Fig. 8-12 Information window "Empty filters"

 Touch middle icon "FILTER DRAINING".

A message asking you to open the substitution port is displayed.
 Open the substitution port.
The filters are emptied and aerated. After approx. 90 s the message ”HDF filter
empty” is displayed.

For complete emptying, the emptying button should remain active for about 3 to 5
minutes. Minor residues remaining in the filters are unavoidable.

IFU 38910273EN / Rev. 2.11.00 / December 2011 8-19

HDF-online/HF-online Dialog+

 For the HDF filter, open filter cover 1; for the DF filter, open filter cover 2. Use a
suitable screwdriver and open the cover.
 Remove used-up filters and replace them with new ones.
 Close the filter cover(s) and relock them with the screwdriver.

Fig. 8-13 Filter housing with cover

 To complete the filter change, touch the middle icon "EMPTY FILTERS" once more.
 Close the substitution port.

 Reset the filter data using the icons "DF" and "HDF".
 Fill and rinse the filter.
 Carry out disinfection with citric acid 50 %.

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Dialog+ HDF-online/HF-online

8.5.4 Sampling of substitution fluid

For hygienically faultless sampling of the above mentioned fluid proceed as follows.
 Prepare the device as usual.
 Insert the substitution line.
 Start therapy (without patient).
 Adjust substitution rate to 200 ml/min.
 Extract the required amount for your sample from the infusion connection of the
substitution line.
 End therapy.
 Start disinfection.

IFU 38910273EN / Rev. 2.11.00 / December 2011 8-21

HDF-online/HF-online Dialog+

8-22 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Single-needle procedure

Table of contents

9 Single-needle procedure..................................................................... 9-3

9.1 Single-needle cross-over (SN-CO) ..................................................... 9-3
9.1.1 Preparing the therapy ..............................................................................9-3
9.1.2 Level regulation (if present)...................................................................9-5
9.1.3 Running the therapy ................................................................................9-7
9.1.4 Ending the therapy ...................................................................................9-8
9.2 Single-needle valve (SN-valve) .......................................................... 9-9
9.2.1 Preparing the therapy ..............................................................................9-9
9.2.2 Running the therapy ............................................................................. 9-11
9.2.3 Ending the therapy ................................................................................ 9-12

IFU 38910273EN / Rev. 2.11.00 / December 2011 9-1

Single-needle procedure Dialog+

9-2 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Single-needle procedure

9 Single-needle procedure

9.1 Single-needle cross-over (SN-CO)

In the following we describe the single-needle procedure only as far as it differs from
double-needle dialysis. For detailed operating information see chapter 4., 5. and 6.

9.1.1 Preparing the therapy

Insert tubes
The following is required:
• SN-CO tube system
• Dialog+ with two blood pumps

 Insert arterial tube and chamber.

 Push arterial tube through arterial tube clamp.
 Insert venous tube and chamber.
 Push venous tube through venous tube clamp.
 Insert venous pump segment into venous blood pump just immediately before
connecting the patient. 9
 Connect pressure sensors PA, PBE, PBS, PV. Check for secure seat.

SN-CO can also be activated or selected with a therapy in progress.

If the PBS pressure sensor is connected during an ongoing therapy, and the SN-CO
modus is selected, then, the dialysis machine checks the PBS pressure sensor and the
plausibility of the action. The result must be confirmed by pressing the Enter key 
on the monitor.

IFU 38910273EN / Rev. 2.11.00 / December 2011 9-3

Single-needle procedure Dialog+

Fig. 9-1 Single-needle cross-over (SN-CO) tube system

Risk of blood loss due to arterial line leakage upstream of the tube clamp!
9  Ensure that there are no connection leaks and that the tube system is fully
WARNING intact.

Setting the SN-CO mode

 Touch icon.

Legend
1 Set SN-CO parameters
2 Activate SN-CO parameters
3 Connect patient
4 Call up single-needle selection

Fig. 9-2 Single-needle cross-over (SN-CO)

9-4 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Single-needle procedure

 Touch SN-CO field.

Fields not needed will be hidden.

Fig. 9-3 SN-CO parameters

 Fill and rinse tube system, see section 4.5.

 Set level in chambers as follows:
arterial approx. 50 % of chamber volume
venous approx. 35 % of chamber volume.
After completion of preparations, icon 3 is enabled.
9
9.1.2 Level regulation (if present)

The level regulation system allows the user to set blood levels in the blood line
chambers in single-needle cross-over mode by screen touch.

The user is obligated to check for correct setting of the levels in the chambers.

In SN-CO mode, the blood level regulation requires a previous blood pump stop
automatically performed by the machine.

 Touch icon
The level window opens. All chambers are paled (inactive).

IFU 38910273EN / Rev. 2.11.00 / December 2011 9-5

Single-needle procedure Dialog+

Fig. 9-4 Level regulation screen in single-needle

9  Touch button
A supervisor window opens.

 Confirm by pressing the Enter key.

Blood pump stops automatically.
A pressure equalisation is performed by opening the arterial and venous clamp.
The chambers are active and ready to adjust.

Level increasing
 Touch icon gently with one touch and observe level.
 Touch again for the correct setting if necessary.

Level decreasing
 Touch icon gently with one touch and observe level.

The level regulation is performed with the preset blood flow speed, but with a
maximum of 400 ml/min.

 To determine the level regulation process, press button “Adjust levels”

or
 press level regulation icon.
Blood pump restarts automatically with preset values.

9-6 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Single-needle procedure

Risk to the patient due to infection by contamination of the manometer

protection filter of the blood lines!
 Change manometer protection filter on the machine if the manometer
WARNING protection filter of the blood lines has been in contact with blood.
 Call technical service for manometer protection filter change.

Risk of reduced dialysis effectivity!

 Ensure that no air enters into the dialyser when decreasing the level in the
WARNING arterial and in the PBE chamber.

9.1.3 Running the therapy

 Touch icon.
The dialysing machine switches to connection mode.
 Confirm patient data, see section 5.1.
 Connect arterial tube.
 Insert tube segment of venous blood pump. Ensure that the pressure gauge line for
the blood pump control pressure is located upstream of blood pump inlet.
 Start blood pumps.
 Fill tube system with blood. 9
 Stop blood pumps.
 Connect venous tube to patient.
 Restart blood pumps.
– At 150 ml/min for central catheter
– At approx. 100 to 120 ml/min for fistula connection
The dialysis is started.
 Increase blood pumping rate, taking into account the phase volume.

Alternatively, the double-needle mode could be used. Therefore, the venous pump
tube segment will be inserted after connecting the venous patient access.
 Then change into SN-mode
 Confirm window on the screen.
 Start blood pump.
Dialysis starts.

Risk to patient due to reduced dialysis effectiveness because of a high

recirculation ratio with a small phase volume!
 Set phase volume between 30 and 35 ml.
WARNING
 Use vascular accesses with flow rates as high as possible.

IFU 38910273EN / Rev. 2.11.00 / December 2011 9-7

Single-needle procedure Dialog+

Changing the phase volume

For changing the phase volume, the control pressures can be set within certain limits
depending on the patient's connection conditions.

Arterial control pressure Venous control pressure

For
CO PA CO PV

Central catheter
up to -200 mmHg 360 to 390 mmHg
Good fistula

Delicate fistula up to -150 mmHg 300 mmHg

First puncture -120 to -150 mmHg 250 to 300 mmHg

 If necessary, change phase volume through control pressures CO PA and CO PV:

– To increase the phase volume: Increase interval between CO PA and CO PV.
– To decrease the phase volume: Reduce interval between CO PA and CO PV.

During dialysis
 Observe levels in arterial and venous chamber.
If necessary, change levels in field SN chamber level, see below.

9  Observe phase volume.

The phase volume reacts to:
– Changes in the blood flow
– Changes in the control pressures
– Blood levels in the chambers
– Pressure changes in shunt
– Blood pump stop in case of an alarm
 In case of repeated alarms ”Phase volume to low”: Briefly reduce pump speed.
The limits are reset.

9.1.4 Ending the therapy

The therapy ends automatically or after touching the respective icon. Also observe the
following steps.
 Leave tube segment of venous blood pump in venous blood pump.
 Always start reinfusion by pressing the appropriate icon.
 Disconnect patient, see chapter 6.

Alternatively, it can be re-infused by double-needle mode.

 Touch field 2 in SN-CO window (Fig. 9-2).
 Deactivate SN-CO.
 Disconnect the patient (see chapter 6).

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Dialog+ Single-needle procedure

9.2 Single-needle valve (SN-valve)

In the following we describe the single-needle valve procedure only as far as it differs
from double-needle dialysis. For detailed operating information see 4., 5. and 6.

9.2.1 Preparing the therapy

Inserting tubes
The following is required:
• AV set for SN-valve (venous chamber 100 ml) or normal AV set for Dialog (venous
chamber 30 ml)
• For Dialog+ single-pump machine: Option SN-valve with arterial tube clamp
(without arterial tube clamp increased recirculation will occur)

Low effectiveness due to high recirculation ratio at small phase volumes when
single-pump machines without SN-valve option are used!
WARNING  Set phase volume >12 ml.

9
 Insert standard arterial tube.
 Push arterial tube through arterial tube clamp (if present).
 Insert venous tube.
 Place venous tube through venous tube clamp.
 Connect pressure sensors PA, PBE, PV. Check for secure seat.

SN-valve can also be selected during a running therapy.

IFU 38910273EN / Rev. 2.11.00 / December 2011 9-9

Single-needle procedure Dialog+

Setting the SN-valve mode

 Touch icon.
The following screen appears:

Legend
1 Set min. arterial control
pressure
2 Set venous control pressure
3 Activate SN-valve parameters
4 Connect patient
5 Call-up single-needle selection

9
Fig. 9-5 Single-needle valve (SN-valve)

It is possible to set a lower max. limit to protect the arterial pressure limit.

 Touch field SN-valve.

The field lights up in green.
The preset control pressures min. PV and max. PV are displayed.

Fig. 9-6 SN-valve parameters

In order to achieve the highest effective blood flow at minimum recirculation, the
control pressures must be set for an optimum phase volume.

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Dialog+ Single-needle procedure

9.2.2 Running the therapy

 Touch icon.
The dialysis machine switches to therapy mode.
 Confirm patient data, see section 5.1.
 Connect patient, see section 5.2.
 Fill tube system with blood. Fill level in venous chamber to only approx. 35 % in
order to achieve a good phase volume.
 Start blood pump and slowly increase speed depending on the vascular condition of
the patient.
The dialysis is started.
During dialysis, the following phase volume should be reached:
• For standard-AV set with 30 ml chamber: 12–18 ml
• For AV set for SN-valve with 100 ml chamber: 15–25 ml
In order to change the phase volume, the control pressures can be set within certain
limits depending on the patient's connection conditions.

The level regulation system (if present) allows the user to set blood levels in the blood
line chambers in single-needle valve mode by screen touch. See section 9.1.2.

9
Recommendation

Lower venous control pressure min PV Upper venous control pressure max PV

120 to 150 mmHg up to 300 mmHg

 If necessary, change phase volume through control pressures min PV and max PV:
– To increase the phase volume: Increase interval between min PV and max PV.
– To decrease the phase volume: Decrease interval between min PV and max PV.
 Make certain the phase volume does not drop below 12 ml.
The phase volume reacts to:
– Changes in the blood flow
– Changes in the control pressures
– Blood levels in venous chambers
– Pressure changes in shunt
 Observe level in venous chamber.
If necessary, change level via field SN chamber level.
 If necessary, adjust min. PV and max. PV, see section 4.7.
The optimum return flow time is set automatically.

IFU 38910273EN / Rev. 2.11.00 / December 2011 9-11

Single-needle procedure Dialog+

9.2.3 Ending the therapy

The therapy ends automatically or after touching the respective icon, see section 5.4.
Also, observe the following steps.
 Leave tube segment of venous blood pump in venous blood pump.
 Always start reinfusion by pressing the appropriate icon.
 Disconnect patient, see chapter 6.

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Dialog+ Use of options

Table of contents

10 Use of options .................................................................................... 10-3

10.1 ABPM blood pressure monitoring..................................................... 10-3
10.1.1 Cuff........................................................................................................ 10-3
10.1.2 Settings ................................................................................................ 10-5
10.1.3 Start/stop measurement.................................................................. 10-8
10.1.4 Showing and graphically displaying measured values ........... 10-8
10.2 bioLogic RR® Comfort - automatic blood pressure stabilisation
with the guideline method ..............................................................10-10
10.2.1 Mode of operation ..........................................................................10-10
10.2.2 Setting of systolic blood pressure lower limit (SLL) and
maximum ultrafiltration rate.......................................................10-12
10.2.3 Setting of suggested systolic blood pressure lower
limit (SLL)...........................................................................................10-14
10.2.4 Activating/deactivating bioLogic RR® Comfort......................10-14
10.2.5 Graphical representation of ultrafiltration and blood
pressure progression.......................................................................10-15
10.3 Adimea...............................................................................................10-17
10.3.1 Setting the parameters..................................................................10-17
10.3.2 Graphic representation during therapy.....................................10-18
10.3.3 Target warning.................................................................................10-20
10.3.4 Extended functionality when using the patient
therapy card......................................................................................10-21 10
10.3.5 Kt/V table...........................................................................................10-23
10.4 Bicarbonate cartridge holder ..........................................................10-24
10.4.1 Inserting the cartridge ...................................................................10-24
10.4.2 Changing the cartridge during dialysis.....................................10-25
10.4.3 Emptying the cartridge after dialysis ........................................10-28
10.5 Central concentrate supply .............................................................10-28
10.6 Dialysis fluid filter............................................................................10-29
10.6.1 Use and mode of operation ..........................................................10-29
10.6.2 Changing dialysis fluid filter ........................................................10-30
10.6.3 Resetting the data ..........................................................................10-33
10.6.4 Disinfection.......................................................................................10-34
10.6.5 Sampling of dialysis fluid..............................................................10-35
10.7 Emergency power supply/battery ...................................................10-37
10.7.1 Charging indicator ..........................................................................10-38
10.7.2 Automatic battery test ..................................................................10-38
10.7.3 End of battery operation ...............................................................10-39
10.8 Communication interfaces ..............................................................10-39
10.8.1 BSL (Bed Side Link) .........................................................................10-39
10.8.2 DialogP+P-computer interface (DCI)...............................................10-39
10.8.3 Staff call ............................................................................................10-39
10.9 Crit-Line Interface ...........................................................................10-40
10.9.1 Function .............................................................................................10-40
10.9.2 Set-up and connection with the DialogP+P .................................10-42
10.9.3 Setting ................................................................................................10-43
10.9.4 Graphical presentation of trends................................................10-45

IFU 38910273EN / Rev. 2.11.00 / December 2011 10-1

Use of options Dialog+

10.9.5 Reading of the data from the patient therapy card ..................10-46

10-2 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Use of options

10 Use of options

10.1 ABPM blood pressure monitoring

The option ABPM (automatic blood pressure monitoring) allows non-invasive,

oscillometric blood pressure measurements.
The blood pressure can be measured in the operating modes Preparation, Therapy and
Disinfection.
ABPM blood pressure monitoring offers the following functions:
• Simple immediate measuring prior, during and after the dialysis treatment
• Clear display of blood pressure and pulse readings on the dialysis main screen
• Automatic, cyclic measuring
• Blood-pressure based individual limits adjustment on the press of a button
• Optional colour display of blood pressure and pulse curves
• Documentation of readings with time stamps
• Readings outside the limits are coloured

Risk of haematoma formation caused by frequent blood pressure measurements

of patients who take coumarins or other anticoagulant substances.
WARNING

The automatic blood pressure monitoring function does not release operators from
the obligation to regularly monitor the patient. 10
The information transmitted and displayed by the option may not be used as only
source of information for the medical indication.

10.1.1 Cuff

The following cuffs can be used for ABPM blood pressure monitoring:
• Small (upper arm size 18 – 26 cm)
• Medium (25 – 35 cm)
• Large (33 – 47 cm)
A ”Medium” size cuff is supplied with every system delivered.

Applying the cuff

Infection risk to the patient due to a contaminated cuff!

 When infectious (e.g. Hepatitis B) patients are treated, a separate cuff must
WARNING be used for each patient.

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Use of options Dialog+

The cuffs delivered by B. Braun are latex free.

 Vent cuff prior to application. Compress cuff to let air escape.

Fig. 10-1 Cuff

10
 Apply cuff tightly in a suitable place around upper arm of the patient.
 Place marking on inside of cuff over artery.
 Ensure that cuff tube is not kinked.
 If applicable, set measuring cycle to the desired time interval (1 - 60 min depending
on the clinical situation).

• Do not apply cuff to limbs used for intravenous infusion or haemodialysis.

• Apply cuff tightly making certain that there is no venous flow-back or skin
discolouration.
• Do not apply cuff in areas where blood circulation is impaired or where there is
a risk of impairment to the blood circulation.
• Apply cuff as closely as possible to the forearm (approx. 2 cm above the elbow).
• Using the wrong cuff size can lead to wrong measurements.

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Dialog+ Use of options

Cleaning/sterilising the cuff

Never autoclave the cuff.

 Ensure that no fluid enters the tube connections during cleaning.

 Only clean cuff with soapy water or an alcohol solution (e.g. Meliseptol®).

Sterilising the cuff

 Only sterilise the cuff with ethylene oxide (ETO).

Connecting the cuff tube to the dialysis machine

 Connect cuff tube to tube connection for blood pressure measurements at the
dialysis machine. Ensure correct seat of connections.

10.1.2 Settings

 Touch icon.
The settings menu appears.

 Touch icon.
The ABPM main view appears: 10

Legend
1 Set the alarm limits
2 Set the cycle time, in minutes
3 Activate/deactivate cyclical
measurement
4 Start/Stop ABPM

Fig. 10-2 ”ABPM main view” screen

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Use of options Dialog+

The window shows the data of the last two measurements:

• Time: Time (h:min)
• Systolic pressure: Systole (mmHg)
• Diastolic pressure: Diastole (mmHg)
• Mean pressure: MAP (mmHg)
• Pulse: Rate (1/min)

Setting for cyclical measurement

 To set the measuring period (cycle time: 1 to 60 minutes), touch icon 2.
 To activate/deactivate the cyclic measurements within the set time interval, touch
icon 3.

The TSM allows a preset to determine whether the cyclic measurements are
terminated by changing to Disinfection mode.

Setting the alarm limits

 To view and set the alarm limits, touch icon 1.
The following screen appears:

Fig. 10-3 ”Alarm limits” screen

You can accept or adjust the alarm limits.

Option 1: Manual setting of alarm limits:
 Touch the limit to be set.
 Enter new setting via the keypad.

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Dialog+ Use of options

Option 2: To set the alarm limit based on the last measuring result:
 Touch field Individual limit adaption.
New limit settings are suggested on a coloured background.
 Confirm limit settings by pressing Enter key on monitor.

Alarm limit values

Alarm limit Lower Upper
Lower limit 65 245
systolic (but not higher than set upper
limit systolic)
Upper systolic 65 245
alarm limit (but not lower than set lower
limit systolic)
Lower limit 40 220
diastolic (but not higher than set upper
limit diastolic)
Upper limit 40 220
diastolic (but not lower than set lower
limit diastolic)
Lower pulse rate 40 200
(but not higher than set upper
pulse rate)
Upper pulse rate 40 200
(but not lower than set lower
pulse rate)

10
After an initial measurement, the alarm limits should be set closer around the current
blood pressure values.
The suggested alarm limits normally range around ± 30,
in critical areas at ± 10 mmHg around the last measured value.
To ensure best possible measurements, the cuff should be at heart level so that the
measured blood pressure does not differ from the actual blood pressure due to the
height difference.

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Use of options Dialog+

10.1.3 Start/stop measurement

Fig. 10-4 ”Therapy” screen

 Touch field 1 on the ”Therapy” screen (Fig. 10-4) and field 4 in the ”ABPM main
10 menu” window (Fig. 10-2).
The last values measured for the systolic and diastolic pressure and the pulse rate are
being displayed.
 To stop an ongoing blood pressure measurement, touch the respective field again.

10.1.4 Showing and graphically displaying measured values

Important!
Erroneous measurements are marked by an asterisk in the first position. By activating
a line with an asterisk a window with the measuring results and an error description
is called up.

When a measurement was canceled, the display field appears in yellow and shows
”---/---”.
The display field is also highlighted in yellow when the limits are exceeded.
In the measurement overview, all results are displayed with the respective time
information. Values shown in red indicate that limits have been exceeded.

 Touch icon in ABPM main window (Fig. 10-2).

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Dialog+ Use of options

The following screen appears:

Legend
1 Measured values at the time
selected in field 4.
2 Cursor
3 Arrow fields for moving the cursor
4 Selected time
5 Switch on/off graphic display

Fig. 10-5 Graphical representation of measured results

There are three different formats for graphic display.

 To switch between display formats: Touch number field 1.
10

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10.2 bioLogic RR® Comfort - automatic blood pressure

stabilisation with the guideline method

10.2.1 Mode of operation

The automatic blood pressure stabilisation bioLogic RR® Comfort is an innovative

biofeedback system with the objective to prevent hypotensive episodes. The
ultrafiltration rates of a preset ultrafiltration profile are adapted by the input of an
intelligent combination of predicted, current and past blood pressure values. The
system is based on the experience that patients have individual blood pressure
progression patterns during a therapy. Typical blood pressure progressions from the
past together with currently measured values are used for ultrafiltration control and
saved in a patient-related memory (Patient Therapy Card or Nexadia) after each
treatment (max 100).
During the treatment, the guideline method searches in the data memory of the
patient for the curve with the best correlation and takes it as the guideline. This
evaluation is repeated after each blood pressure measurement.
The system takes blood pressures in defined intervals, which are extended during
treatment depending on the UF withdrawal. In contrast to former bioLogic RR®
versions, the intervals can be 20 or 30 minutes, resulting in a reduction of the total
number of measurements. If hypotensive crises occur, the extended intervals are
reduced to five minutes until the patient's blood pressure has stabilised.
The user can set a patient-individual limit, the so-called Systolic Lower Limit (SLL). If a
measured blood pressure reaches this set value + 25 %, the system starts to reduce
the UF rate. For example, if the SLL is set to 80 mmHg, the system will start to lower
10 the UF rate already when 100 mmHg (80 mmHg + 25 % = 100 mmHg) is reached.
Unlike former biologic RR® versions, the three initial HD treatments of a patient do no
longer require blood pressure measurements with five minute cycles. The software
operates with primary guidelines (statistically representative guidelines).
Additional manual RR measurements, e.g. during a longer interval, are taken into
account by the system.
The bioLogic RR® Comfort option is only available in combination with the ABPM
option.

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Dialog+ Use of options

Fig. 10-6 Measuring intervals

Phase Duration Achieved UF volume Regular measurement interval

1 variable up to 65 % 20 minutes
2 variable from 65% 30 minutes
* in case of stable blood pressures (blood pressure > 1.25 x systolic lower limit)

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Use of options Dialog+

10.2.2 Setting of systolic blood pressure lower limit (SLL) and maximum
ultrafiltration rate

 Touch the icon in the “Preparation” or “Therapy” mode.

The following screen is displayed:

Fig. 10-7 bioLogic RR® Comfort Parameter screen

 Set the parameters for bioLogic RR® Comfort according to the following table.

Item Text Range Description

1 Max. UF rate in % 100–200 % Enter max. UF rate for treatment with bioLogic RR® Comfort
either as absolute value or as percentage of the average UF rate.
To guarantee an effective regulation of the UF rate and the
2 bioLogic RR® Comfort 100–4000 ml/h optimal saving of blood pressure measurements, we recommend a
max. UF rate max. UF rate of  160 %.
3 Set suggested SLL as 65-80 mmHg Suggests an SLL which has been determined from previous
required therapies.
The setting is performed by pressing this button.
(Can be optionally set in TSM)

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Dialog+ Use of options

Item Text Range Description

4 SYS lower limit 65–130 mmHg Lower limit for systolic blood pressure
Recommendation:
To guarantee an effective regulation of the UF rate and the
optimal saving of blood pressure measurements, we recommend
the assumption of the suggestion value.
If this function is deactivated, the value should be determined by
the attending physician.

5 bioLogic® RR Comfort Activated/deactivated Activating/deactivating bioLogic® RR Comfort

6 UF volume – Display of the ultrafiltration volume, set under "UF-parameters"

7 UF time Display of the treatment period set under "UF-parameters"

–

8 Suggested SYS lower limit Display of the suggested SLL

-
(Only when the function has been activated)
9 Act./Req. UF volume - Displays the UF volume reached in percent

10 Average UF rate - Display of the average UF rate set under "UF-parameters"

11 Total of inf. volume Displays the accumulated infusion volume of the current therapy
–

The SLL and max. UF rate/bioLogic RR® Comfort max. UF rate parameters should be
10
determined by the attending physician. The SLL should be set as low as possible in
the range of the known tolerance of the patient

The reaching of the dry patient weight within the set therapy period can conflict
with stable blood pressure behaviour.
The attending physician can decide to:
• Adapt the UF volume
• Extend the therapy period
• Accept that the UF target was not achieved.

For medical reasons, all values can also be adapted during the therapy

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Use of options Dialog+

10.2.3 Setting of suggested systolic blood pressure lower limit (SLL)

 Touch the "Set suggested SLL as required" field. The value shown on button 4, Fig.
10-7, is accepted.
 Optionally, set a value with button 4.

When accepting an SLL that was suggested by the system, the user should assure the
plausibility of this value relative to the patient’s tolerance.

In the first five minutes after the therapy start the bioLogic RR® Comfort functions
can be switched off again. As from the sixth minute a prompt must be additionally
confirmed: Are you sure ...?. After confirmation of this prompt the functions cannot
be activated again!
As from the sixth minute the text in the fields is displayed in blue to point out that
the first five minutes have expired.

The "Set suggested SLL as..." function can be activated/deactivated in the TSM.

10
10.2.4 Activating/deactivating bioLogic RR® Comfort

Drop in blood pressure due to increasing UF rate!

When the bioLogic RR® Comfort option is switched off, an increase of the UF
rate can occur due to a lower UF volume when the software of the Dialog+ P
P

attempts to compensate for the deficit!

CAUTION  Pay attention to the UF rate after switching off.
 If necessary, reduce the UF volume.

 To activate bioLogic RR® Comfort touch button 5, Fig. 10-7.

 To deactivate bioLogic RR® Comfort touch button again.
Depending on the current status, automatic blood pressure stabilisation is started or
terminated.

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Dialog+ Use of options

The bioLogic RR® Comfort option does not have the “basic” bioLogic RR® function:
unlike previous versions the guideline mode cannot be switched off.

Possibly activated UF profiles are deactivated after switching on bioLogic RR®

Comfort!

10.2.5 Graphical representation of ultrafiltration and blood pressure progression

 Touch the icon in the "ABPM Main Overview" screen (Fig. 10-2).
An overview with the icon for graphical representation is displayed.

 Touch icon.
The following screen is displayed:

Legend
1 Measured values for the systolic
and diastolic blood pressures as
well as for the pulse at the
selected time; also functions as 10
button for switching between
different graphical
representations
2 Graphical progression of systolic
blood pressure and
ultrafiltration rate
3 ON/OFF button for the screen
with the graphic bioLogic RR®
Comfort representations

Fig. 10-8 Graphical representation of blood pressure and pulse

 Touch icon.
The following screen with the representation of the bioLogic RR® Comfort parameters
is displayed:

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Use of options Dialog+

Legend
1 Graphical display of the
bioLogic RR® Comfort values
2 UF rate at the selected time
3 Reference value for the UF rate
at the selected time
4 Systolic blood pressure at the
selected time
5 Systolic blood pressure over the
period of the treatment
6 Cursor
7 Reference line for the UF rate
over the treatment period,
probable progression
8 Arrow keys for selection of a
point in time
9 Graphical display of delivered
UF rate within an interval.

Fig. 10-9 Graphical representation, progression of ultrafiltration

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Dialog+ Use of options

10.3 Adimea

If the option Adimea is selected, the theoretical calculation of the effectiveness as

described in chapter 2.8 is not applicable.

The option Adimea is an exact measuring method for precise monitoring of the dialysis
dose during a complete dialysis therapy.
The system works with spectroscopy (UV light) in order to measure the reduction of
urinary waste products in the dialysate outlet of the dialysis machine. Due to
continuously recorded measurements the Kt/V and the urea reduction ratio (URR) can
be determined and displayed. Besides the mentioned parameters, it is also possible to
show the behaviour of the UV light absorption, allowing to evaluate the reduction of
substances during the complete therapy.

Two calculation methods are available for calculation of Kt/V and URR:
• Single pool Kt/V (spKt/V)
• Equilibrated Kt/V (eKt/V)
The selection is performed once in TSM mode. The calculation method set is displayed
on the screen.

10.3.1 Setting the parameters

 Input of patient weight before dialysis (Fig. 10-10, 1). Setting the parameter
enables the calculation and display of Kt/V, URR and UV absorption.
10
 Input/adaptation of the target Kt/V value (Fig. 10-10, 2).
 Enable/disable target warning (Fig. 10-10, 3). If the target warning is enabled, the
system informs the user whether the target value will possibly not be reached at
the end of therapy. In that case the user can adapt the parameters in order to reach
the determined dialysis dose.
 The user can directly access three parameters which influence the Kt/V without
changing the menu. Those are therapy time, blood flow and dialysate flow.
Influences on curves and values will be displayed after a short processing time.

The introduction of the patient weight and, therefore, the activation of the Kt/V
measuring function can be done at any time during therapy. The displayed Kt/V and
URR and UV light absorption always consider the already achieved dialysis time.

IFU 38910273EN / Rev. 2.11.00 / December 2011 10-17

Use of options Dialog+

Legend
1 Input of patient weight before
dialysis
2 Input/adaptation of the target
Kt/V value
3 Enable/disable target warning

Fig. 10-10 Setting parameters

10.3.2 Graphic representation during therapy

10
 By touching the icons ”Kt/V“ and/or ”URR“ and/or ”UV absorption“ it is possible to
change between the parameter display. A graphical and numerical overview of the
current therapy is displayed on the respective screen.
 A blue line represents the actual progress of the respective parameter until the
respective time of therapy.
 A green dashed line serves as orientation for the user to see whether the actual
therapy progress will fulfill the target dialysis dose. If the blue curve is above the
green dashed one, the target Kt/V will probably be reached at the end of therapy.

Explanation of coloured lines

Red line Target value at the end of therapy

Blue line Actual progress line Kt/V, URR or UV absorption

Green dashed line Orientation line of complete therapy

Black dashed line Previous completed therapy (new feature)

Red dashed line Prediction that target value will not be reached
(extension of blue line)
Blue dashed line Prognosis
(extension of blue line)

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Dialog+ Use of options

Legend
1 Chose Kt/V and/or URR and/or
UV absorption
2 Actual progress line of the
Kt/V (graphical display) and
actual Kt/V value (numerical
display)
3 Orientation line of complete
therapy

Fig. 10-11 Graphical display

In haemodialysis (HD) mode the user gets a “prognosis” of the estimated Kt/V value at
the end of therapy. It is displayed numerically (Fig. 10-12, 1) and graphically (Fig. 10-
12, 2). The blue actual progress line will be extended from the actual therapy status in
10
order to predict the therapy progress.
This functionality is not available in HDF and Single-needle mode.

Fig. 10-12 Numerical and graphical display of the prognosis

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Use of options Dialog+

10.3.3 Target warning

If the “Target warning” is enabled, the machine will inform the user showing a yellow
warning on the screen in case that either Kt/V resp. URR will not be reached at the
end of therapy.
The warning is displayed if either the blue actual progress line (Fig. 10-13, 1) has
already been below the green dashed orientation line (Fig. 10-13, 2) or if it could fall
below it within the remaining therapy time (Fig. 10-14).

10
Fig. 10-13 Graphical display of blue actual progress line below green dashed
orientation line
In the second case the blue line (Fig. 10-14, 1) will be extended by a red dashed line
(Fig. 10-14, 2) predicting that the target value will not be reached.

Fig. 10-14 Graphical display of parameters at the end of therapy

10-20 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Use of options

 Adapt the parameters according to the following table:

Text Range Description

1 Kt/V target value 0.00 – 3.00 Input of a Kt/V target value

2 Therapy time 1 h – 10 h

3 Dialysate flow 100 ml/min – 800 ml/min

4 Blood flow 30 ml/min – 600 ml/min Adjustment via the +/- keys on the monitor

Risk to the patient by the input of new treatment parameters.

 Ensure that the change of the treatment parameters corresponds with the
WARNING prescription of the physician.

Risk to the patient by the input of new treatment parameters.

 The treatment parameters may not be determined on the basis of the
measured Kt/V.
WARNING  A measurement of the Kt/V does not replace the therapy prescribed by the
physician.
10

10.3.4 Extended functionality when using the patient therapy card

Using the patient therapy card allows to store the patient’s individual Kt/V parameters
and graphic Kt/V or URR therapy progresses. Therefore, data are still available for the
user after the end of therapy. It is possible to store up to 12 completed therapies and
to compare them graphically or to evaluate Kt/V and URR values of up to 50
completed therapies. Trends or unusual therapies can be identified and analysed if
necessary.

The graphical display will be shown by touching the respective icons.

 Touch the icon.

Up to 12 completed therapies are displayed:

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Use of options Dialog+

Fig. 10-15 Display of up to 12 stored therapies

 By touching one of the displayed therapies the screen showing the black dashed
progress line (Fig. 10-16, 1) opens:
10

Fig. 10-16 Display of the black dashed progress line

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10.3.5 Kt/V table

 Touch the icon.

The data are read from the therapy card and displayed on the screen

Fig. 10-17 “Kt/V Table” Screen 10

Text Description

1 Therapy date and time [dd.mm.yyyy, h:min] Date and time of performed therapies

2 Target Kt/V [-] Set Kt/V target value

3 Patient weight [kg] Patient weight before dialysis

4 ACTUAL therapy time [h:min] Actually performed therapy time

5 Average blood flow [ml/min] Average blood flow over the therapy period

6 Average dialysate flow [ml/min] Average dialysate flow over the therapy period

7 ACTUAL URR [%] Achieved urea reduction ratio

8 ACTUAL Kt/V [-] Reached Kt/V value

9 Calculation method (spKt/V, eKt/V) Set calculation method

 Touch the icon to exit the display.

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Use of options Dialog+

10.4 Bicarbonate cartridge holder

Risk to the patient!

 Only use bicarbonate cartridges Solcart B by B. Braun Avitum AG or
bicarbonate cartridges that have been released for use with this dialysis
machine.
WARNING  Never use cartridges containing substances other than bicarbonate.
 Never use bicarbonate cartridges containing acid concentrates for
”Bicarbonate with NaCl”.

• Observe datasheet of bicarbonate cartridge.

• Ambient temperatures of > 35 °C due to, e.g. direct exposure of the bicarbonate
cartridge to sunlight, or large temperature differentials between, e.g. store and
treatment room can lead to increased gas formation in the cartridge. This may trigger
an alarm, or the bicarbonate content in the dialysate may deviate slightly from the
specified value.
• When using a bicarbonate cartridge, the concentrate rod for the bicarbonate
remains in the machine, and the coupling on the concentrate rod. As soon as the
holder is opened, the dialysis machine detects that a cartridge is to be used.

10.4.1 Inserting the cartridge

Fig. 10-18 Inserting a cartridge

 Press in lateral button at top fixing and pull up top fixing as far as possible.
 Using your left hand place cartridge between top and bottom fixings. At the same
time, place inlet and outlet necks of cartridge into their respective recesses at the
top and bottom fixings.
The lever at the top fixing is automatically pushed back in the process.

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Crushing hazard!
 When closing the cartridge holder do not bruise hands or fingers!
CAUTION

 To close the cartridge holder, press top fixing centrally onto the cartridge.
The cartridge is pierced, automatically vented and filled with permeate.

10.4.2 Changing the cartridge during dialysis

When the cartridge is empty, the bicarbonate conductivity alarm is triggered and an
information window appears. An almost empty cartridge can be replaced before an
alarm is activated.

With draining

 Touch icon.

Fig. 10-19 Bicarbonate cartridge change

 A confirmation window appears, confirm by pressing the Enter key .

 The cartridge will be drained (in case TSM Bic cartridge with draining is selected).
An information window appears after some seconds.

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Use of options Dialog+

Fig. 10-20 Bicarbonate cartridge change with draining

 Insert new cartridge.

 After inserting the new cartridge, confirm by pressing the Enter key .
The machines prepares the new Bic cartridge.
10

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Dialog+ Use of options

Without draining

 Touch icon.

Fig. 10-21 Bicarbonate cartridge change

10
 A confirmation window appears, confirm by pressing the Enter key .
 The cartridge will not be drained, only the presure will be released (if Bic cartridge
without draining is selected).
 An information window appears when the empty cartridge can be taken out.

Fig. 10-22 Bicarbonate cartridge change without draining

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Use of options Dialog+

10.4.3 Emptying the cartridge after dialysis

 Connect both couplings to the rinsing bridge.

 Touch icon and confirm by pressing the Enter key on the monitor.
The cartridge is emptied automatically.

The functions ”Empty dialyser” and ”Empty cartridge” can be started simultaneously,
although, they are carried out successively.
The cartridge is emptied as long as both couplings are connected to the dialyser or
the rinsing bridge.
If the blue coupling is connected to the rinsing bridge, the dialyser is emptied.

10.5 Central concentrate supply

Fig. 10-23 ”Central concentrate supply” connections

When using a dialysis machine equipped with the ”Central concentrate supply” option,
the concentrate (acetate or bicarbonate components) does not have to be provided in
containers but can be obtained from the central supply. Both components can be
obtained centrally or individually from containers. Another option is combining a
bicarbonate cartridge with acid components from central concentrate supplies.
 To connect the concentrate, place couplings of suction rods onto connections of
the central concentrate supply, which are located on the dialysis machine below
the rinsing quivers. Observe colour-coding!
The concentrate connections of the dialysis machine are, thus, directly connected to
the wall connections of the central concentrate supply.

10-28 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Use of options

10.6 Dialysis fluid filter

10.6.1 Use and mode of operation

The dialysis fluid filter is a hollow-fiber filter. It is used for performing haemodialysis
therapy with ultra pure dialysate. Even if the machine has been correctly cleaned and
disinfected, the permeate and the bicarbonate concentrate, which, unlike the acid-
containing concentrate, is not autosterile, can be the source of possible
contamination.

Risk to patients due to uncontrolled fluid withdrawal!

External leaks on the filters (e.g. faulty tube connections or damaged seals) will
affect the UF control system of the dialysis machine!
WARNING
 Prior to each treatment, visually inspect filters for external leaks.

Time of filter change

See relevant data sheet for the specified service life of the dialysis fluid filter in use.
The filter must be changed, when:
• the number of therapies set in the service program has been reached,
• the set number of operating hours has been reached,
• the test of the dialysate system during preparation is not passed and leaks are
discovered at the filter.
10

The dialysis fluid filter may only be operated with permeate or dialysate.

IFU 38910273EN / Rev. 2.11.00 / December 2011 10-29

Use of options Dialog+

The dialysis fluid filter must be changed at the latest when the following warning
window is displayed on the screen:

Fig. 10-24 "Filter change" warning window

10 10.6.2 Changing dialysis fluid filter

The dialysis machine supervises remaining operating hours of the filter as well as
performed therapies. Operating hours are hours in Therapy as well as hours in
Preparation and Disinfection.
When either the operating hours or the number of therapies are reached, a warning
window will be displayed on the screen. It informs the user about the upcoming filter
change. The warning window appears in case that 60 operating hours or 10 therapies
remain. It is displayed when the user changes from Program Selection to Preparation
and it lasts for 1 minute.
The number of hours or therapies is set by the technician in the TSM. It is
recommended to change the filter after 150 therapies or 900 operating hours.

Preconditions
• No patient connected to dialysis machine
• Dialysis machine switched on
• Screen Disinfection selection is displayed, no disinfection program started (machine
is in Rinse out, see figure 10-25)

Risk to the patient!

 Only use dialysis fluid filter Diacap® Ultra by B. Braun Avitum AG or dialysis
fluid filters that have been released for this dialysis machine by the respective
WARNING
manufacturer.

10-30 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Use of options

 Touch icon.
A screen is displayed.

 Touch icon.
The following screen is displayed:

Fig. 10-25 "Filter draining" warning window

The remaining dialysis time and the number of performed dialyses are displayed.
 Touch the "FILTER DRAINING" icon.
A prompt to remove the dialyser feed connector is displayed.

 Remove the dialyser feed connector.

The filter is drained and vented. After approx. 90 s, the message "DF filter drained" is
displayed.

IFU 38910273EN / Rev. 2.11.00 / December 2011 10-31

Use of options Dialog+

10 Fig. 10-26 Dialysis fluid filter change

 Remove all couplings (red and blue) from the filter. Catch the fluid escaping in the
process.
 Hold old filter centrally and remove it from the clamping brackets of the filter
holder.
 Hold new filter centrally and press it into the clamping brackets of the filter holder.
 Push blue couplings onto dialysate couplings on the filter caps.
 Push red couplings onto lateral dialysate connections.
 Reset data with the dialysis machine switched on.

After filter installation/change

It is recommended to record the installation/change of the dialysis fluid filter in the
machine logbook (date, batch number).
The Operating time and Number of dialyses data must be reset, see section 10.6.3.

10-32 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Use of options

10.6.3 Resetting the data

Preconditions
• The dialysis machine is switched on.
• The disinfection selection screen is displayed.

 Touch icon.
A screen appears.

 Touch icon.
The following screen appears:

Fig. 10-27 ”Select Disinfection” screen with active window ”Filter change”

 Touch icon to reset operating time and number of dialyses.

 Confirm query by pressing the Enter key on the monitor.

IFU 38910273EN / Rev. 2.11.00 / December 2011 10-33

Use of options Dialog+

10.6.4 Disinfection

The dialysis fluid filter is a fixed part of the dialysis machine for the entire duration of
its use. It is cleaned and disinfected together with the dialysis machine.

Suitable disinfectants
The following agents are suitable for disinfecting the dialysis fluid filter Diacap® Ultra:
• Citric acid 50 % (hot disinfection)
• TIUTOL® KF (only two times during runtime and immediately prior to a filter change)

Unsuitable disinfectants may cause changes to the material characteristics of

the housing, encapsulation and capillaries of the filter!
Risk to the patient! The dialysis machine is no longer safe to operate!
 Only use suitable disinfectants.
WARNING
 Essentially check information leaflet supplied with filter.
 Before using other disinfectants contact B. Braun service technician.

Unsuitable disinfectants
The following substances may not be used for disinfecting the dialysis fluid filter:
• Chlorine-containing fluids and organic solvents, e.g. chloroform, acetone, ethyl
10 alcohol.
• Watery solutions, e.g. sodium hypochlorite (bleaching lye) or soda lye.
The manufacturer will not accept any liability if unsuitable disinfectants are used.

There may be a risk of uncontrolled UF withdrawal from a patient due to a

calcified dialysis fluid filter.
 To prevent this, perform decalcification with Citric Acid 50 % after each
WARNING
treatment.

10-34 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Use of options

10.6.5 Sampling of dialysis fluid

Sampling of dialysate for microbiologic analysis

Samples of the dialysate can be taken regularly in order to perform hygienic
inspections. Since quantities > 100 ml are frequently required, these should not be
taken during treatment.

Samples can be taken at the dialyser feed connector (blue) via the piercing
membrane.
As an option, a sample port can be installed in the dialyser feed line. A sample can be
taken directly there with a suitable syringe with Luer connector.

Proceed as follows to take such a sample:

 Prepare the equipment.
 Start therapy (without patient, no bypass).
 Disinfect the injection socket in the dialysis fluid connection/sample port.
 If required, switch off the TMP limiting value window.
 Slowly withdraw the sample with a suitable needle/Luer syringe.
 Place the sample taken into a suitable container. Avoid contact with the container.
 Terminate the therapy.
 Disinfect the equipment.
10
Legend
1 Sample port
2 Injection socket

Fig. 10-28 Sample port

IFU 38910273EN / Rev. 2.11.00 / December 2011 10-35

Use of options Dialog+

Sampling to check the composition of the dialysis fluid

Small quantities can be taken regularly to check the composition of the dialysate.
Proceed as follows to take such a sample:
 Once the conductivity of the dialysate has stabilised (after approx. 5 minutes),
disinfect the sample port.
 Slowly withdraw the sample with a suitable cannula at the injection socket or with
a small syringe, e.g. a 2 ml syringe, at the sample port (see figure).
 Analyse the dialysate by, e.g. the following methods:
- pH measurement
- blood gas analysis
- chemical determination of bicarbonate concentration (titration)

Recommended therapeutic ranges

pH 7,2-7,5
pCO2 B B 40-60 mmHg
-
HCO3 B PB
P
25-38 mmol/l

Risk to patient due to UF deviations when the sample port leaks.

 Ensure that the sampling port does not leak after use.
 Install the sampling port according to the enclosed installation instructions.
 Fluid leaks from the sample port cause an increase in weight reduction.
10 WARNING  Check the sample port for air inlet.
If necessary, remove the air.
Have the sample port replaced by the service.
T T

Risk to the patient due to contamination

 Do not use the sample port for rinsing the extracorporeal circulation.
 Do not connect the arterial line for reinfusion to the sampling port.
WARNING
 Only use sterile syringes.

Risk to the patient due to incorrect composition of dialysate.

When the dialysate flow is stopped, the samples taken could provide incorrect
measuring results!
 Always perform sampling during therapy in the main connection, never in the
WARNING bypass!
 Use only calibrated measuring equipment.
 Do not perform sampling during disinfection.

10-36 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Use of options

10.7 Emergency power supply/battery

The battery operation mode serves for maintaining the extracorporeal blood
circulation in case of a mains power failure.
In such event, the dialysis machine automatically switches to battery operation.
• ”Battery/bypass” will be displayed in the status line.
• The remaining battery life is shown in the patient name field.
• This is followed by an acoustic signal.
• The alarm message ”Power failure – battery operation” is displayed.
This message must be confirmed.

Active functions during battery operation

The following functions and monitoring devices are active during battery operation:
• Screen and control elements
• All blood-sided functions and alarms
• Blood pumps
• Tube clamps
• Air detector SAD
• Heparin pump
• Blood pressure monitoring
• Single-needle operation
• Arterial bolus with bag
In the ”end” mode, all blood-side functions are active during battery operation as
during mains operation. If necessary, the patient can be disconnected in the usual 10
way.

Functions not available during battery operation

The following functions are not available during battery operation:
• Dialysate treatment
• Ultrafiltration
• Substitution, for HDF/HF-online
• Bolus administration, for HDF/HF-online
• Emptying the dialyser and cartridge
• Rinsing, disinfecting

Battery operating time

After a successful automatic battery test the battery has an operating time of at
least 20 minutes. Switch off the machine after 20 minutes in order to guarantee the
lifetime of the battery.
When mains power fails repeatedly, the battery will function for the residual
operating time after each power failure.

IFU 38910273EN / Rev. 2.11.00 / December 2011 10-37

Use of options Dialog+

Switching off in battery operation

If the equipment is switched off in battery operation, it cannot be switched on again
after a time span of 16 minutes unless it is connected to the mains.

10.7.1 Charging indicator

An indicator light in the keyboard membrane of the screen indicates that the battery
is being charged while the system is operating on mains power. Battery charging
continues even when the machine is switched off. The indicator light goes dark as
soon as the battery is fully charged.

10.7.2 Automatic battery test

During the automatic machine test performed at each call-up for dialysis, the battery
function is tested, too. In case of an unsuccessful automatic test, an information
message appears. The test could be unsuccessful for the following reasons:

Cause Action

Battery not fully charged, e.g. because the machine has  Charge battery.
not been connected to mains power for some time.

Faulty battery.  Inform technical service.

10 Fuse of battery has been triggered due to a technical  Inform technical service.
defect.

Dialysis after an unsuccessful automatic battery test

Dialysis can be started although the battery self-test was not passed. The battery is
charged. Take into account that battery operation is not available or only for a
limited time during a mains power failure.

Battery change
To maintain the battery functionality, we recommend replacing the battery at least
every 5 years.
For correct disposal of the battery please refer to service manual.

10-38 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Use of options

Risk to the patient due to blood loss.

When the blood flow stops, because of blood pump failure during loss of mains
power, blood clotting causes blood loss.
WARNING
 Return blood to patient manually (see chapter 13.4.).

10.7.3 End of battery operation

As soon as the mains power supply has been restored, the battery operation is
automatically ended. The dialysate treatment is activated again. Once the unit has
adjusted itself to the set values, dialysis is automatically continued. User intervention
is not required.

10.8 Communication interfaces

The dialysis machine has a RS232 communication interface for communicating with
other information systems. Only one of the systems described below can be installed.

10.8.1 BSL (Bed Side Link)

With the BSL, the dialysis machine can be connected to the data management system
Nexadia®. For further information see Nexadia® instructions for use.

10.8.2 Dialog+-computer interface (DCI)

10
P
P

The Dialog+-computer interface allows transferring various parameters to other EDP

P P

(Electronic Data Processing) systems installed on the ward.

For further information see instructions for use of the Dialog+-computer interface.
P
P

10.8.3 Staff call

The staff call is used for integrating the dialysis machine into an existing staff call
system.

The user may not solely rely on the function of the staff call option during the event
of an alarm. Regular checking of the status of the patient is still required.

For further information see staff call system technical information.

IFU 38910273EN / Rev. 2.11.00 / December 2011 10-39

Use of options Dialog+

10.9 Crit-Line Interface

10.9.1 Function

The Crit-Line unit from Hema Metrics™ is an external measuring instrument which
measures non-invasively various parameters in the blood via optical sensors. For this
purpose, a suitable cuvette (disposable measuring chamber) must be placed on the
dialyser inlet line.
The following parameters of the blood are measured or calculated:

• Haematocrit content of the blood (HCT) in %

• Oxygen saturation of the blood in %
• Flow in the vascular access in ml/min
• Recirculation in the vascular access in % (calculated)
• Change of the blood volume in % (calculated)

The serial interface of the Hema Metrics™ Crit-Line device is connected to the rear of
the Dialog+ DSI (Dialog Serial Interface) using its serial connection cable.. The
P
P
P
P

measured data of the Crit-Line unit are, thus, shown on the display of the Dialog+, P
P

saved on the Patient Therapy Card and can be recalled as trends.

B. Braun provides the serial DSI for the Dialog+ to the Crit-Line unit.
P
P

B. Braun is neither responsible for the correct functioning of the Crit-Line unit or
10 guaranteeing the correctness of the displayed values.
Dialog+ displays the data measured by Crit-Line on the monitor.
P P

Hazard of leakage currents!

 When operating the Dialog+ with Crit-Line, use only the class II mains adapter
P P

supplied by Hema Metrics™.

 Do not position the mains adapter on the Dialog+. P
P

 Do not connect the Crit-Line mains adapter to a different voltage phase than
the Dialog+ is connected to.
P
P

DANGER  When operating the Crit-Line with the Dialog+ do not connect the serial data
P
P

adapter to a different interface (for example a PC) than that of the Dialog+. P
P

 Do not connect ANY other serial device to the DSI interface than the Hema
Metrics™ Crit-Line device or other devices released from B. Braun for
operation with the DSI interface.

Hazard of short circuits!

 While cleaning the surface of the Dialog+, avoid water or disinfectant around
P
P

DANGER the DSI interface. Wipe with a damp cloth only!

10-40 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Use of options

Hazard of electric shock!

 It is mandatory to use a potential equalisation connecting the Crit-Line unit to
an installed potential equalisation pin in the dialysis centre if catheter patients
are treated.
 Place the Crit-Line mains adapter in a dry area.
DANGER
 Do not connect the Crit-Line potential equalisation cable to the Dialog+. P
P

 Before Crit-Line mains adapter operation, carefully check connection of power

cord and power receptacle.

Hazard of electromagnetic interferences!

 The Dialog with the DSI interface complies with IEC 60601-1-2 with respect
to its EMC behavior.
WARNING  When several electrical devices are combined, the user has to ensure that no
electromagnetic interferences occur in the existing working environment.

Risk to patient by the input of new treatment parameters!

 The Crit-Line monitoring of the relative blood volume, oxygen saturation and
haematocrit does not relieve the user from the duty of performing regular
patient checks.
WARNING
 Treatment decisions should not be made on the basis of the displayed Crit-Line
values alone.

10
Risk to patient due to missing alarms because of incorrect limit values settings!
 The reaching of alarm limits is indicated by Dialog+, however, this has no
P P

effect on the therapy.

WARNING
 Set level carefully and follow the instructions of the physician.

Risk to patient due to inconsistent values!

 For setting the max. haematocrit limit and/or the min. saturation limit, please
carefully follow the relevant clinical practices.
 Crit-Line alarms are displayed on the Dialog+ through single channel
WARNING
P P

communication. A single fault condition with the Dialog+ software may result
P
P

with alarms from the Crit-Line not being properly displayed.

Risk of device incompatibility!

 The DSI is compatible with Crit-Line III TQA from Hema Metrics™ only.
 Compatibility with older or future models of the Crit-Line cannot be
CAUTION guaranteed. Contact your Hema Metrics™ customer service for more
information.

Risk of handling error!

 Please study and follow carefully the Reference Manual of Crit-Line unit and
CAUTION all the necessary user documentation of Crit-Line unit!

IFU 38910273EN / Rev. 2.11.00 / December 2011 10-41

Use of options Dialog+

10.9.2 Set-up and connection with the Dialog+ P

 Attach the cuvette between the arterial line and the dialyser.
 Place the Crit-Line unit on the Combi Shelf Holder (Art. No. 7102871) behind the
monitor or on a safe, dry place.
 In case catheter patients are treated:
- Connect potential equalisation cable (Art. No. 7106605) to potential equalisation
bolt on the back of the Crit-Line unit.
- Connect other end of the potential equalisation cable to the facility potential
equalisation connector.
 Connect power plug of Crit-Line unit to wall or operate the unit on battery.
 Plug in and tighten the Crit-Line unit serial adapter RS232 socket with the DSI
interface RS232 plug of the Dialog+.
P
P

 Connect the sensor clip with the cuvette.

It is recommended that the unit be switched on during therapy selection or

preparation to enable initial communication between the Dialog+ and the Crit-Line.
P
P

For further information on Crit-Line set-up please read carefully the Crit-Line
operation manual.
After the blood pump starts in therapy mode, measurements on the Crit-Line unit
should start immediately. For all other settings on the Crit-Line unit, follow the
instructions in the associated instructions for use from Hema Metrics™.

10 Hazard of incorrect Delta BV value during therapy!

 If the unit is switched on during therapy mode, the software calculates the
relative blood volume based on the first valid haematocrit value which results
WARNING in an incorrect Delta BV value.
 Start the measurement immediately after therapy start.

10-42 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Use of options

10.9.3 Setting

With the Crit-Line option enabled by the technician in TSM and the Crit-Line
connected to the Dialog+, the message "CL enabled" is displayed in the upper part of
P
P

the screen.

 Touch the icon in the “Preparation“ or “Therapy“ mode.

 The settings overview is displayed.

 Touch the icon.

 The Crit-Line main screen is displayed.

Fig. 10-29 Crit-Line Main Window

IFU 38910273EN / Rev. 2.11.00 / December 2011 10-43

Use of options Dialog+

Item Text Range Description

1 CL Start button enabled/disabled Starts the serial communication

between Crit-Line and Dialog+ P
P

2 CL Trend n/a Shows the current and the last 20

graphical Crit-Line data trends
3 CL table n/a Reads the last 50 Crit-Line data of
Patient Therapy Card
4 Access recirculation -100 – 0 % Display of calculated recirculation
(in %)
5 Blood flow in access 50 – 2500 ml/min ± Display of currently measured
15 % blood flow (in ml/min)
6 Oxygen saturation 55 – 100 % Display of currently measured
oxygen saturation (in %)
7 Delta BV -100 – 0 % Display of blood volume change
(in %)
8 Actual haematocrit (HCT) 20-70 % Display of currently measured
haematocrit value (in %)
9 Min. limit of saturation 55-100 % Display of lower oxygen
saturation limit (in %)
10 Max. limit of haematocrit 20-70 % Display of upper haematocrit
value (in %)

10
Touching button 1 activates the function and the data transmission process from the
Crit-Line unit to the Dialog+ begins. The transferred parameters are displayed in fields
P
P

4 to 8, exclusively in therapy mode. The oxygen saturation limit is set with button 9
and the haematocrit limit with button 10. The default values can be accepted or
changed. An alarm is triggered when the values are exceeded.
The values are updated every 6 seconds. To obtain information concerning the portion
of the recirculation of the vascular access, a saline bolus must be administered. See
the relevant chapters in the Crit-Line instructions for use from Hema Metrics™.

The values are also displayed in the overview window.

 Touch the icon.

10-44 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Use of options

Fig. 10-30 Crit-Line Overview

10.9.4 Graphical presentation of trends

When button 2 in Fig. 10-29 touched, the trends of haematocrit, blood volume change
in percent, recirculation, access blood flow and oxygen saturation can be displayed. A 10
trend group consisting of three trends is displayed on the screen. The trend groups can
be edited by touching the trend button (5) (see chapter 11.10).

Fig. 10-31 Crit-Line Trends

IFU 38910273EN / Rev. 2.11.00 / December 2011 10-45

Use of options Dialog+

The haematocrit and Delta BV limits are also displayed. The HCT limit (1) corresponds
to the value set in Fig. 10-29nd the BV limit (2) is calculated from the HCT start value
and the HCT limit. Line 3 shows the oxygen saturation limit.
The trend history (4) shows the actual progression as well as the last 20 saved trends.

Treatment parameters at a defined point in time:

There are two ways by which the treatment parameters can be determined at a
defined point in time:

1st option:
 Directly enter the time (7) in the Time window.

2nd option:
 Move the time reference line by using the icons << or >> (6).

10.9.5 Reading of the data from the patient therapy card

Touch button 3 in Fig. 10-29 The saved data are read from the patient therapy card
and displayed. The table saves up to 50 Crit-Line progressions and includes the
following parameters:

• Date and time

• Haematocrit: Start value, maximum, end value

10 • Delta BV: Minimum and end value

• Oxygen saturation minimum
• Recirculation

10-46 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Use of options

Fig. 10-32 Crit-Line Table

A yellow background field states an abnormal deviation during the use of the Crit-Line
device. This can be the case in particular when the unit is not used during the
complete therapy. 10
Parameter Condition for abnormal deviation
Date/Time The first valid date/time information is not available until
5 minutes after the blood pump start.
HCT Start The first valid HCT value is not available until 5 minutes after
the blood pump start.
HCT Max. At least 5 successive HCT values are missing or are incorrect.
HCT End If the therapy will end in more than 5 minutes.
DeltaBV Min. At least 5 successive DeltaBV values are missing or are incorrect.
DeltaBV End If the therapy will end in more than 5 minutes.
Sat Min. At least 5 successive saturation values are missing or are
incorrect.

The table can also be called up in the End of Therapy phase by touching the
"Parameter" and "Folder" icons.

IFU 38910273EN / Rev. 2.11.00 / December 2011 10-47

Use of options Dialog+

• For all the set conditions of alarms/warnings the monitor must be enabled (Crit-
Line button pressed in CL Parameter Window).
• If the monitor will be disabled (Crit-Line button released in CL Parameter
Window) all the alarms/warnings are reset.
• The occurrence of “Crit-Line communication failed” warning resets all the other
alarms and warnings.
• The “Set/check HCT Limit!” warning is immediately withdrawn if the HCT limit
button is pressed – even if the value is not modified. The limit may also be set
prior to the enabling: in this case the related warning does not occur at all.

10-48 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

Table of contents

11 Configuration ..................................................................................... 11-3

11.1 Automatic switch-off ........................................................................ 11-3
11.2 Weekly disinfection program ............................................................ 11-5
11.3 Configuring weekly disinfection program ....................................... 11-6
11.4 Configuring profiles ........................................................................... 11-9
11.4.1 Basic principles................................................................................... 11-9
11.4.2 Setting profile parameters .............................................................. 11-9
11.5 UF profiles.........................................................................................11-11
11.5.1 Select UF profiles.............................................................................11-11
11.5.2 UF profile table.................................................................................11-13
11.6 Patient therapy card ........................................................................11-18
11.6.1 Erasing data from patient therapy card....................................11-18
11.6.2 Entering the patient name............................................................11-19
11.6.3 Reading patient data ......................................................................11-20
11.6.4 Storing patient data (parameter settings)................................11-20
11.7 Entering parameters for computing the effectiveness of the
dialysis ...............................................................................................11-21
11.8 Adjusting the monitor brightness...................................................11-26
11.9 Select language of screen text .......................................................11-27
11.10 Edit parameter of trend groups......................................................11-28 11

IFU 38910273EN / Rev. 2.11.00 / December 2011 11-1

Configuration Dialog+

11-2 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

11 Configuration

11.1 Automatic switch-off

If the automatic switch-off function is activated, the machine will switch-off

automatically after each manually started disinfection. A time-out can be set by the
user.
Example:
Time-out 45 min -> the machine will switch-off 45 min after the disinfection is
completed, if there is no user action during the time out.
The automatic switch-off function is independent from the weekly disinfection
program.

Fig. 11-1 Selection of disinfection program

 Touch icon in Disinfection mode

 A window will open.

IFU 38910273EN / Rev. 2.11.00 / December 2011 11-3

Configuration Dialog+

Fig. 11-2 ”Auto Switch-Off” screen

 Set time by using the number buttons.

 Accept time by touching icon O.K.
 To start program, press the Start Auto switch off button.
 To change the time-out, enter anytime in Disinfection Selection or Disinfection.
 To stop the program, press the Stop Auto switch off button.
11
Leave mains switch of dialysis machine switched on.
Ensure that sufficient disinfectant is connected.

11-4 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

11.2 Weekly disinfection program

The weekly program “Weekly disinfection program” simplifies the configuration of the
operations.

 Touch icon in Disinfection mode (see Fig. 11-1)

 The following window opens:

Fig. 11-3 Scheduled auto disinfection screen

Item Text Comment

1 Scheduled auto The next programmed disinfection is indicated.

disinfections
2 Week day Any week day from Monday till Sunday can be entered, also
several times, if more than one operation per day is required.
3 Start time The start time of the operation can be entered.
4 Method The following methods can be entered:
- Rinsing
- Thermal
- Citric Acid 50%
- Central Thermal
- None

IFU 38910273EN / Rev. 2.11.00 / December 2011 11-5

Configuration Dialog+

Item Text Comment

5 Switch-off Enter whether the machine shall remain switched-on after

the operation or shall switch-off.
Yes: The dialysis machine will be switched-off right after the
entered method.
No: The dialysis machine will remain switched-on right after
the entered method.
6 Mark rows to delete

7 Delete Deletes all marked rows

8 New New rows can be added to the table (21 in total).

9 Start Program The weekly disinfection program is started with this button.
It runs until (10) is pressed.
10 Stop Program The weekly disinfection program is stopped with this button.
It is stopped until (9) is pressed.
11 Cancel Leave window without saving setting

OK Leave window with saving setting

Leave mains switch of dialysis machine switched on.

Ensure that sufficient disinfectant is connected.

11 The auto switch-off and the weekly disinfection program have to be activated in
TSM.

11.3 Configuring weekly disinfection program

The dialysis machine can be configured in such a way that it automatically switches
on, carries out a disinfection and switches off again. The parameters of the automatic
disinfection can be set for one week.

 Touch icon on disinfection screen.

The weekly disinfection program screen is displayed.

11-6 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

Fig. 11-4 Weekly disinfection program (Example)

Fig. 11-4 shows the set-up for the following disinfection modes:

Day/time Description
Monday

0.00 hrs. A thermal, central disinfection is carried out. The machine switches 11
on automatically and off again after disinfection.

6.30 hrs. A chemical disinfection with citric acid 50 % is carried out. The
machine remains switched on after disinfection.

Tuesday

0.00 hrs. The unit is rinsed from the central water supply. The machine
switches itself on automatically and off again after rinsing.

6.30 hrs. A chemical disinfection with citric acid 50 % is carried out.

Wednesday

During night No disinfection is carried out.

6.30 hrs. A chemical disinfection with citric acid 50 % is carried out. The
machine remains switched on after disinfection.

IFU 38910273EN / Rev. 2.11.00 / December 2011 11-7

Configuration Dialog+

 Use scroll bar 1 to move to other weekdays.

 Touch respective field and change settings.
The settings are automatically stored.
The following setting options are available:
• No disinfection
• Thermal disinfection
• Central thermal disinfection
• Central chemical disinfection
• Rinsing
• Long chemical disinfection (only daytime setting)
• Short chemical disinfection/cleaning (only daytime setting)

The automatic start of the preparation of the dialysis machine in the morning must
be activated in the service program.
With the setting ”Day/rinsing”, the dialysis machine changes to the ”Preparation/test”
mode after switch-on.
Upon completion of an automatic night action, the dialysis machine switches itself
off again.
Upon completion of an automatic day action, the dialysis machine remains in ”Rinse-
out” mode.

11-8 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

11.4 Configuring profiles

11.4.1 Basic principles

Parameters are set as absolute or constant values or as profiles with a time-adjusted

progress.
The following parameters are available for profiles:
• Dialysate flow
• Dialysate temperature
• Conductivity (overall)
• Ultrafiltration
• Heparin
• Bicarbonate conductivity
For ultrafiltration, a selection of ten programmed or one individual profile is available.

11.4.2 Setting profile parameters

The setting of the parameters is explained using the conductivity (Na+) profile as an
example.

Legend
1 Profile settings
2 Enter therapy parameters
3 Heparinisation data
4 Pressure limits 11
5 Ultrafiltration data
6 Dialysate parameters

Fig. 11-5 ”Conductivity” screen

 Touch icon 2.
 Touch icon 6.
 Touch icon 1.

IFU 38910273EN / Rev. 2.11.00 / December 2011 11-9

Configuration Dialog+

The following screen appears:

Legend
1 Linear profile
2 Exponential profile
3 Parameter bar
4 Duration of parameter bar
5 Therapy time setting
6 Manual input of the total value
= resetting the profile to
horizontal shape
7 Value for the selected
parameter bar

Fig. 11-6 ”Profile parameters” screen

The ”profile parameters” screen contains a graphic with ten parameter bars,
representing the treatment time. In other words: Based on a 4 h (240 min) therapy
time, one parameter bar covers 24 min.
Four options for adjusting the parameters are available.
11 Option 1: Manual adjustment of values
 Adjust values by moving each parameter bar 3 on the touch screen, using your
finger.
Option 2: Direct entry
 Touch the parameter bar to be adjusted.
 Touch icon 7.
 Enter value directly via the keypad or through icons +/-.
 Accept value by touching icon O.K.
Option 3: Automatic (linear/exponential) distribution
 Select first parameter bar.
 Touch icon 7.
 Enter value via keypad and confirm with icon O.K.
 Select last parameter bar.
 Touch icon 7.
 Enter value via keypad and confirm with icon O.K.
 Touch icon 1 or 2 to automatically distribute values linearly or exponentially.
Option 4: Create a developing profile by moving the finger over the diagram.
 Positioning the finger at the first or last bar.
 Move the finger over all bars along the desired developing profile.

11-10 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

Fig. 11-7 Edit profile

11.5 UF profiles

11.5.1 Select UF profiles

Apart from the individual settings, the dialysis machine offers standardised
11
ultrafiltration profiles. As another option, an individual UF profile can be preselected
at any time and stored on the patient therapy card or via BSL after the dialysis
therapy. The profile table contains descriptions to the different profiles.

 Touch icon.
The "UF parameters" screen appears.

 Touch icon.
The "UF profile" screen appears.
The UF rate setting is specified above each parameter bar.

IFU 38910273EN / Rev. 2.11.00 / December 2011 11-11

Configuration Dialog+

Legend
1 Profile number
2 Next profile number
3 Previous profile number
4 UF without dialysate
(sequential therapy)
5 UF with dialysate

Fig. 11-8 ”UF profile” screen

 Touch icon 2 or 3 to select other UF profiles.

Apart from the even ultrafiltration profile (profile 0), nine other UF profiles are
available.
 Touch icon 4 or 5 to change from ”Dialysate flow (HD)” mode to sequential therapy
11 (SEQ).
The sequential phase is highlighted in yellow.

Risk of dehydration!
 A sequential therapy for a period of over 2 hours may only be set up on the
WARNING instruction of a doctor.

Risk of hyperpotassemia/hypercalcaemia!
Carrying out a whole therapy in “sequential” mode may lead to increased blood
values of the patient.
WARNING  A sequential therapy for a period of over 2 hours may only be set up on the
instruction of a doctor.

Risk of cardiovascular instability through high UF exposure!

 Regard to the patients individual constitution by adjusting the UF profile.
WARNING  The responsible physician should be informed.

11-12 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

During automatic calculation, the last bar is adjusted depending on the total value.

11.5.2 UF profile table

Profile no. Description

0 Standard profile -
Constant UF rate over entire therapy time.

11
1 Particularly gentle therapy start and end phases, due to stepped UF rate
increase/reduction.

IFU 38910273EN / Rev. 2.11.00 / December 2011 11-13

Configuration Dialog+

Profile no. Description

2 Particularly gentle therapy start due to stepped UF rate increase.

3 Particularly gentle therapy end due to stepped UF rate decrease.

11-14 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

Profile no. Description

4 In the first section, the sequential operating mode is set automatically.

Suitable for patients from whom most of the fluid has to be extracted at the
beginning of the treatment.

5 Particularly suited for starting up parallel flow dialysers.

IFU 38910273EN / Rev. 2.11.00 / December 2011 11-15

Configuration Dialog+

Profile no. Description

6 The sequential operating mode is automatically set in the last section.

Suitable for patients from whom most of the fluid has to be extracted at the end of
the treatment

7 Alternating stressful and gentle phases during the initial treatment period, with
constant fluid removal at the end of the treatment.

11-16 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

Profile no. Description

8 Alternating stressful and gentle phases at the end of the dialysis.

9 Alternating stressful and gentle phases during the second treatment period, with
constant fluid removal at the beginning of the treatment.

10 Freely settable.
When a given profile is changed, the machine assigns a name to it and stores it as
profile 10. When the profile is changed again, the previous profile is overwritten.
11 – 30 Profiles no. 11 to 30 can be preset by the technical service according to customer
requirements.

IFU 38910273EN / Rev. 2.11.00 / December 2011 11-17

Configuration Dialog+

11.6 Patient therapy card

The Card reader can be installed as an option on Dialog+ machines.

The patient therapy card offers the option of individually storing nearly all pre-
settings for a therapy and calling them up again at the preparation stage.
Also, treatment results from up to 50 therapies can be stored after a therapy.

The patient therapy card should be ordered from B. Braun to have a certified quality
standard.

11.6.1 Erasing data from patient therapy card

 Touch icon.
The selection menu appears.
 Insert therapy card into drive.

 Touch icon
11 All data on the patient therapy card will be erased!

11-18 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

11.6.2 Entering the patient name

Fig. 11-9 Recording the patient name

The patient name can be entered in field 1 of the input screen.

 Touch field 1.
The keyboard appears on the screen.
11
Legend
1 Entry field
2 Delete all characters to the left
of the cursor
3 Delete all characters
4 Delete all characters to the
right of the cursor
5 Insertion mode
6 Shift key
7 Special characters on
8 Special characters off

Fig. 11-10 Patient name keyboard

 Enter patient name in field 1 using the keyboard, and confirm with icon O.K.

IFU 38910273EN / Rev. 2.11.00 / December 2011 11-19

Configuration Dialog+

When working with the patient therapy card, an additional field ”Patient number” is
displayed in the ”Patient Overview” screen. This helps to differentiate between
patients with the same name.

11.6.3 Reading patient data

Patient data can only be read in the Therapy selection and Preparation modes.

 Insert patient therapy card into Card reader.

 Touch icon.
The read-in operation is displayed on the screen.

 Check data in overview. Change to second page, where applicable.

If the patient therapy card contains data that for technical reasons cannot be read by
the dialysis machine, this red icon appears.
 Touch icon and confirm modification mask for the respective parameter with O.K.
The icon disappears once all faulty parameters have been changed.
Patient data can only be transferred from the card if there are no data left on the
screen that are highlighted by a red background.
 Accept all parameters by touching the O.K. icon appearing in the bottom right
corner.

By inserting the patient therapy card in Therapy selection or Preparation, data is read
automatically.
11
11.6.4 Storing patient data (parameter settings)

 Touch icon after changing the parameter settings.

The patient data are stored on a patient therapy card.
 Save effectiveness data (KtV), see section 11.7.

Machines operated with option Nexadia® BSL have other saving options. These are
described in the respective instructions for use.

11-20 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

11.7 Entering parameters for computing the effectiveness of the

dialysis

 Ensure that patient therapy card has been inserted into the dialysis machine.
 Touch icon.
A screen for entering patient data for calculation of the theoretical effectiveness
opens.

11
Fig. 11-11 Input window for calculating the effectiveness (Kt/V values)

Fig. 11-12 Input window patient data after touching “Watson“ icon (Kt/UV)

IFU 38910273EN / Rev. 2.11.00 / December 2011 11-21

Configuration Dialog+

Item Text Comment

1 Dialysate flow Entry and display of dialysate flow in ml/min

2 Ultrafiltration Entry and display of ultrafiltration volume in ml and profile
Vol./Profile of ultrafiltration
3 Therapy Time Entry and display of dialysis duration in hours and minutes
4 Patient data Entry of:
 Sex
 Age
 Size
 Dry weight
for identification of urea distribution volume using the
“Watson” formula.
5 Blood flow Display of the measured value during dialysis
6 Filter Name Input and display of dialyser in use.
The data must be stored in a table in the service program.
7 PLANNED Entry of intended Kt/V value
8 PROJECTED Computed probable Kt/V value at the end of the dialysis,
calculated with the actual blood flow
9 CURRENT Current Kt/V value determined by the dialysis machine
10 WARNING OFF If the intended Kt/V value (target value) will probably not be
Planned achieved, the dialysis machine automatically displays a

11 warning. To switch off the warning function, activate field

”Warning off”
11 Kt/V table Opens a screen with the table of the patient's Kt/V values
from the patient therapy card
12 Kt/V graphics Opens a graphical display of the planned and actual Kt/V
progression

 Change the following parameters if necessary:

– Filter Name (6)
– Patient data (4)
– Therapy Time in hours and minutes (3)
– Ultrafiltration: Vol./Profile in ml (2)
– Dialysate flow in ml/min (1)
– Planned (7)

Show table
 Touch icon (11).
The Kt/V results are transferred from the patient therapy card and shown in a
screen:

11-22 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

Fig. 11-13 ”Table Kt/V values” screen

Entering laboratory results

As the laboratory results before and after the dialysis are not available at that point,
there is the option of entering these values into the table retrospectively.
 Touch appropriate line.
A screen for entering the laboratory results appears: 11

Fig. 11-14 Entering laboratory results

IFU 38910273EN / Rev. 2.11.00 / December 2011 11-23

Configuration Dialog+

 Enter the following laboratory results:

– Dry weight of patient in kg (1)
– Laboratory result for urea concentration prior to dialysis (mmol/l) (2)
– Laboratory result for urea concentration after dialysis (mmol/l) (3)
 Touch icon.
The table with the current Kt/V figures is displayed. Changed figures are automatically
saved to the patient therapy card.

Show graphics
 Touch icon
A graphical display of the projected and actual Kt/V progression is shown.

Fig. 11-15 Graphical display of Kt/V progression (Projected O.K.)

Item Text Comment

1 Aim Kt/V Planned Kt/V aim

2 Projected Kt/V progression Graphical display of the projected Kt/V progression

3 Actual and current Kt/V Display of actual and current Kt/V progression
progression

4 Current blood flow Display of the momentary blood flow

5 Current Therapy time Display of present Therapy time

6 Projected Kt/V aim Display of projected Kt/V result (O.K., aim Kt/V will be reached, has been
reached)

11-24 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

7 Projected Kt/V aim Display of projected Kt/V result (not O.K., aim Kt/V won’t be reached,
hasn’t been reached)
8 Cursor line Cursor line shows the current therapy moment

Fig. 11-16 Graphical display of Kt/V progression (Projected not O.K.)

Kt/V will not be calculated in the therapy mode “Seq.” and “HF”.

To arrange a correct blood withdrawal according to quality guidelines for a Kt/V

calculation, the Dialog+ changes after the treatment on an UF rate of 50 ml/h.
The blood pump goes on with the selected speed.
A monitoring of the duration of this mode can be carried out by the use of the timer
function.

End Kt/V
 Touch icon on the ”Table Kt/V value” screen.
The screen is closed. All entered data are stored on the patient therapy card. When
closing the screen by touching the icon CANCEL, no data are stored.

IFU 38910273EN / Rev. 2.11.00 / December 2011 11-25

Configuration Dialog+

11.8 Adjusting the monitor brightness

The monitor brightness can be adjusted in the following way:

• Manually, continuously
• Manual switch between preset day/night brightness
This must be activated in the service program.

Procedure
 Touch icon.
The data management screen appears.

 Touch icon.
The screen for adjusting the brightness is displayed.
To set the brightness manually:
 Adjust brightness using the slide displayed on the screen.
”Manual” is displayed at the centre of the screen.
To set the brightness for daytime:
 Activate field Daytime settings.
”Daytime” is displayed at the centre of the screen.
To set the brightness for nighttime:
 Activate the field Nighttime settings.
”Nighttime” is displayed at the centre of the screen.

Screensaver
11 To activate the screensaver:
 Touch the field Yes next to the field Screensaver on.
To deactivate the screensaver:
 Touch field No.
 To close the screen, touch the ”Brightness adjustment” icon.

It is recommended to activate the screen saver.

 To close the screen, touch the ”Data management” icon.

If Screensaver on has been activated with Yes, the screensaver will be activated after
the time preset in the service program.
The screensaver shows 3 moving objects against a dark background:
• Pie chart of therapy time
• Mode
• Time
• If option ABPM is installed, last BP results are shown instead of time
Alarms or touching the screen switch off the screensaver and the active screen
appears again.

11-26 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

11.9 Select language of screen text

Depending on the languages available in the TSM, you can choose the language for
the screen text.

Procedure
 Touch icon
The data management screen appears.

 Touch icon
The screen with all available languages appears.

Fig. 11-17 Screen “available languages“

 Touch row with selected language

 Touch button for changing the language.
Screen text appears in chosen language.

IFU 38910273EN / Rev. 2.11.00 / December 2011 11-27

Configuration Dialog+

11.10 Edit parameter of trend groups

You can edit the combination of parameters within the trend group.

 Call screen “Overview trend groups“ as described in chapter 5.3.5.

Legend
1 Field trend group
2 Button “edit group”
3 Choose TSM presettings
4 Leave screen and save changes
5 Leave screen without saving

11
Fig. 11-18 Screen “Overview trend groups“

Single groups could be edited individually with parameters of your own choice.
 Touch favoured button.
The following screen appears.

11-28 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Configuration

Legend
1 Field “trend group parameters”
2 Field “list of parameters”
3 Scroll bar “trend groups”
4 Scroll bar “list of parameters 2”
5 Leave screen

Fig. 11-19 Edit trend groups

 Touch parameter which is to be replaced in field 1.

Parameter will be marked by a frame.
 Search desired parameter in list 2 and touch it.
The marked parameter will be replaced. 11
 Choose next parameter and replace as described.

 Touch icon to leave the screen.

The screen “overview trend groups” appears.

 Touch icon to save the new trend group.

In the TSM preset trend groups could be set up again.

 Touch icon.











IFU 38910273EN / Rev. 2.11.00 / December 2011 11-29

Configuration Dialog+

11-30 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Maintenance and cleaning

Table of contents

12 Maintenance and cleaning ............................................................... 12-3

12.1 External cleaning................................................................................ 12-3
12.2 Preventive maintenance and technical safety inspection.............. 12-4
12.2.1 Regular preventive maintenance .................................................. 12-4
12.2.2 Technical safety inspection............................................................. 12-5
12.2.3 Accessories, disposable items and expendable parts .............. 12-5
12.3 Technical service and warranty ........................................................ 12-5
12.3.1 Warranty .............................................................................................. 12-5
12.4 Disposal of old dialysis machines...................................................... 12-5

IFU 38910273EN / Rev. 2.11.00 / December 2011 12-1

Maintenance and cleaning Dialog+

12-2 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Maintenance and cleaning

12 Maintenance and cleaning

12.1 External cleaning

Monitor and surface

Electric shock and fire hazard!

 Ensure that no fluid enters the machine.
WARNING  Ensure that no fluid is on the mains plug or mains socket.

Risk of cross-infection because of contamination!

 It is recommended to clean the outer surface of the machine after each
therapy by an appropiate desinfectant.
 In case of surface contamination with blood, disinfect and clean properly.
WARNING
 In case of contamination of pressure connectors with blood, disinfect and
clean properly.

 Clean housing parts and monitor with ethanol (max. 70 %) or isopropanol

(max. 70 %) based cleaning agents.
Hypochlorite-based agents may not exceed a concentration of 0.1 % and may not
be used on the touch foil.
 Use cleaning and disinfection agents only in accordance with the respective
instructions for use.

Wiping the monitor during operation

 Touch icon.
12
The touch foil will be deactivated for 10 seconds and can now be cleaned.

Do not wipe the monitor too moistly. If necessary, dry with smooth cloth afterwards.

Blood pump roller

Do not repeatedly put the blood pump rollers into a disinfectant bath, otherwise the
return safety device can be destroyed.

IFU 38910273EN / Rev. 2.11.00 / December 2011 12-3

Maintenance and cleaning Dialog+

Solutions for external disinfection

Product Concentration Manufacturer

Meliseptol 100 % B. Braun
Melsitt 10 % B. Braun
Melsept SF 10 % B. Braun
Hexaquart plus 10 % B. Braun
Clorox Bleach 0,8 % Clorox Company, USA

12.2 Preventive maintenance and technical safety inspection

12.2.1 Regular preventive maintenance

A regular preventive maintenance (service) is recommended every 12 months

according to the specified check list in the service manual and with reference to the
instructions for use. The preventive maintenance includes the replacement of wear
and tear parts to ensure the fault-free operation of the dialysis machine.
This regular preventive maintenance (service) may only be carried out by trained
personnel.
Depending on the setting in TSM, another maintenance interval can be set (see service
manual chapter 5). If ≤ 5 % of the set time remains the following window (Fig. 12-1)
appears once at the change from End of Therapy to Disinfection.

Fig. 12-1 Preventive Service Recommended

If the set maintenance interval is reached, the above mentioned window appears at
every change to disinfection mode.

12-4 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Maintenance and cleaning

Battery (emergency power supply option)

The battery should be replaced after 5 years to maintain the full functionality of this
option. For correct disposal of the battery please refer to service manual.

Service manual and technical training

A service manual can only be provided after participation in a technical training.

12.2.2 Technical safety inspection

The technical safety inspection shall be performed and documented every 12 months,
according to the specified check list in the service manual and with reference to the
instructions for use.
 The dialysis machine should be checked by persons who have been appropriately
trained or have the required expertise or experience and do not require instructions
for the check.
 Results of the technical safety inspection shall be documented, e.g. by applying an
inspection label to the dialysis machine.
 The technical safety inspection must be kept by the responsible organisation (user)
as part of their documentation.

12.2.3 Accessories, disposable items and expendable parts

Only accessories, disposable items and spare parts may be used that do not pose a
technical safety risk and demonstrably comply with Medical Devices Directive
93/42/EEC (MDD).
To ensure the full functionality of the dialysis machine, we recommend using products
manufactured by B. Braun Avitum AG.

12.3 Technical service and warranty 12

12.3.1 Warranty

For the dialysis machine, B. Braun Avitum AG provides a warranty in line with
statutory requirements. The warranty includes the repair or replacement of parts that
have been damaged because of design, manufacturing or material faults.
The warranty becomes void if the owner or third parties carry out modifications or
repairs to the dialysis machine.
The warranty does not include the remedying of faults caused by manipulation,
incorrect treatment or normal wear.

12.4 Disposal of old dialysis machines

Disinfect the dialysis machine in due form before disposal!

For further information see chapter 1.7.

IFU 38910273EN / Rev. 2.11.00 / December 2011 12-5

Maintenance and cleaning Dialog+

12-6 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Alarms and remedial action

Table of contents

13 Alarms and remedial action.............................................................. 13-3

13.1 Display and reset alarms.................................................................... 13-3
13.2 Alarms and consequences.................................................................. 13-5
13.2.1 Dialysis alarms.................................................................................... 13-5
13.2.2 ABPM alarms.....................................................................................13-13
13.2.3 Crit-Line alarms ...............................................................................13-15
13.2.4 Level regulation alarms..................................................................13-16
13.2.5 Adimea alarms..................................................................................13-17
13.2.6 bioLogic RR® Comfort alarms ......................................................13-18
13.2.7 Online alarms....................................................................................13-19
13.3 Remedying SAD alarms ....................................................................13-21
13.4 Manual blood return ........................................................................13-22
13.5 Omission of acoustic signals ...........................................................13-24
13.5.1 Omission of acoustic signals for alarm .....................................13-24
13.5.2 Omission of acoustic signals for advice ....................................13-24

IFU 38910273EN / Rev. 2.11.00 / December 2011 13-1

Alarms and remedial action Dialog+

13-2 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Alarms and remedial action

13 Alarms and remedial action

13.1 Display and reset alarms

Legend
1 Comment field
2 Information field
3 Alarm field
4 Alarm list
5 Call up comments

Fig. 13-1 Alarm display

 Alarms are displayed in alarm field 3.

 The background of the alarm field changes from green to red.
 An acoustic signal is triggered.
 Signal lights on screen change to red.

13
The service technician can activate an alternative alarm sound in the TSM, which
differ from the continuing alarm sound in an alternating melody.

At failure or disturbance of the loudspeakers, the security system will activate the
power supply buzzer to report an alarm acoustically.
 Please inform your service technician.

Alarms are shown in the alarm list in the order of their occurrence. The triggering
alarm is shown in the alarm field.
Upon resetting the triggering alarm all subsequent alarms are also deleted.

The user is responsible for the reset of an alarm and subsequently for the monitoring
of the suppressed parameters of the dialysis machine.

IFU 38910273EN / Rev. 2.11.00 / December 2011 13-3

Alarms and remedial action Dialog+

Resetting a blood-side alarm

 Press ”Reset alarm” button.
The acoustic signal is switched off.
 Remedy the cause(s) of the alarm.
 Press ”Reset alarm” button.
The dialysis machine is reset to its previous operating condition.

Resetting a dialysate-side alarm

 Press ”Reset alarm” button.
The acoustic signal is switched off.
The background colour of the alarm field changes from red to yellow.
Alarms on the dialysate-side are automatically reset once the cause of the alarm has
been removed.

Warnings or information appear in information window 2. Information field 2 flashes

when more than one information notice has been triggered.
The information field 1 also contains a code number. Note down the code number, in
case you need to contact technical service with possible queries.

 Touch information field 2.

The alarm list 4 is displayed.

Operation in case of monitor failure

In case of a monitor or touch-screen function failure, all monitoring functions and the
signal lamps on the monitor remain active.
To prevent any disconcertion of operator and patient, it is recommended to terminate
13 the therapy. This requires particular attention of the operator.
The blood pump can be controlled via the +/– keys and the START/STOP key.
In case of alarms, special attention must be paid to the blood tube system and the
bubble catcher in front of the SAD. An alarm may only be reset when the user has
verified that the venous patient line does not contain any air.

13-4 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Alarms and remedial action

13.2 Alarms and consequences

13.2.1 Dialysis alarms

Alarm/message/code Cause Remedial action

Arterial pressure upper limit Patient access malfunction.  Check patient access.
(code 1050)
The arterial suction pressure exceeds Incorrect limits setting.  Re-adjust limit.
the preset arterial upper limit.
Incorrect position of cannula.  Correct position of cannula.

Technical defect.  Contact technical service.

Arterial pressure lower limit Excessive pump speed.  Adjust blood flow to patient
(code 1051) conditions.
The arterial suction pressure is lower
than the preset arterial lower limit. Incorrect limits setting.  Re-adjust limit.

Incorrect position of cannula.  Correct position of cannula.

Technical defect.  Contact technical service.

Check AV line for PA monitoring A connection of the arterial line was  If an AV line for pressure
(SUP) (code 1980) not detected at PA. measuring is present, please
connect it to the PA pressure
sensor.
PBE upper limit (code 1048) Excessive pump speed.  Adjust blood flow to dialyser
The blood-sided dialyser inlet pressure and tube conditions.
exceeds the set limit.  Readjust limit.

Blood-side pressure increase in dialyser  Check dialyser for clotting.

(clotting).

 Check tubing system.

Tube kinked.
13
Technical defect.  Contact technical service.

PBE lower limit (code 1049) Tube leaking.  Check tubing system.
The blood-side dialyser inlet pressure
dropped below 10 mmHg. Tube kinked downstream of blood
pump.

Technical defect.  Contact technical service.

Venous pressure upper limit Pump speed too high.  Adjust blood flow to patient
(code 1052) conditions.
Venous pressure exceeds upper limit.
Incorrect position of cannula.  Correct position of cannula.

Clotting in venous drip chamber.  Check venous drip chamber.

Technical defect.  Contact technical service.

IFU 38910273EN / Rev. 2.11.00 / December 2011 13-5

Alarms and remedial action Dialog+

Alarm/message/code Cause Remedial action

Venous pressure lower limit – Check Pump speed too low.  Adapt blood flow to patient
access (code 1053) conditions.
The venous pressure is lower than the
lower limit. Pressure measuring leaking, leading  Produce leak-free connection,
to blood level rise up to the push back fluid column with
syringe.
hydrophobic filter.

Venous cannula pulled out from  Restore connection.

shunt.

Technical defect.  Contact technical service.

Phase volume too low (code 1067) Phase volume significantly lower  Reduce blood flow.
Pressure rise at venous pressure sensor than average.  If necessary, continue adjustment
too high during pump phase. of control pressures.
 Check position of needle/catheter.
Alarm limits: Min. 12 ml

Phase volume too high (code 1064) Phase volume significantly lower  Check that all arterial patient
Pressure rise at venous pressure sensor than average. tube is in place in the arterial
too low during pump phase. clamp.
 Increase blood flow.
 Possibly set closer control
Alarm limits: Min. 12 ml pressures.
 Check tube system for leaks and
entering air.

DF and/or HDF filter holder open Filter holder open at rear:  Close filter holder. A filter change
(code 1047) is only intended to happen in the
- during Preparation
disinfection phase.
- in Therapy or End of Therapy
mode
- during on-going disinfection

HDF-online filter test failed! Leakage.  Repeat filter test. Automatic test
(code 1151) for Online must be repeated by
13 the machine and must be
successful.
 Check filter for leakage.
 If there is no leakage, change
filter.

13-6 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Alarms and remedial action

Alarm/message/code Cause Remedial action

SAD (SUP) (code 1958) Air in SAD region.  Remove air, see text on screen.
SAD – Air! (code 1058)
Level drop in bubble catcher  Correct level in bubble catcher.
Blood pressure too high (foam
formation).

Tube system not an authentic  Use original tube system.

replacement part.

Tube system deformed/scratched or  Ensure during insertion that

damaged otherwise. system is not deformed/scratched
or damaged in any other way.
 Do not leave SAD tube inserted
overnight.

Technical defect.  Contact technical service.

SAD: sensor error (SUP) (code 1961) External sound pulses.  Disconnect patient.
SAD - sensor error (code 1059)
Measuring frequency smaller than
600 Hz.

Technical defect.  Contact technical service.

SAD function ref. (SUP) (code 1962) Technical defect.  Contact technical service.
The alarm level is outside the calibration
value +/-50 mV.

Pump cover open (arterial) Blood pump cover opened.  Close blood pump cover.
(code 1062)
The reed contact in the blood pump Technical defect.  Contact technical service. 13
housing has detected that the blood
pump lid was opened with the pump
running.

IFU 38910273EN / Rev. 2.11.00 / December 2011 13-7

Alarms and remedial action Dialog+

Alarm/message/code Cause Remedial action

Pump cover open (SN/Subst) Blood pump cover open.  Close blood pump cover.
(code 1063)
The reed contact in the blood pump Technical defect.  Contact technical service.
housing has detected that the blood
pump cover was opened with the pump
running.

No heparin delivery –syringe empty? Syringe empty.  Fill syringe.

(code 1065)
Connection line clamped off.  Open clamp.

Unsuitable syringe inserted.  Insert suitable syringe.

Syringe not inserted correctly.  Insert syringe correctly.

Technical defect.  Contact technical service.

Substitution disturbed - leakage? Substitution volume on scales differs  Check tube system for leaks and
(code 1089) from the total substitution volume. kinks.

Technical defect.  Contact technical service.

Water supply disturbed (code 1022) Water pressure too low.  Check water inlet pressure
15 s after activation of the lower reed (minimum pressure 0.5 bar).
contact, the middle reed contact has
not been reached again. The inlet valve Water tap closed.  Open shut-off valve.
is open during this time.
Water inlet tube kinked.  Check inlet tube.

Water inlet valve does not open or  Contact technical service.

pressure reduction valve set incorrectly.

Technical defect.
13 Degassing insufficient (code 1111) Technical defect.  If alarm cannot be reset, contact
The degasification pressure does not technical service.
reach the set value.

Temperature too high (code 1034) Irregular dialysate flow.  If alarm cannot be reset, contact
The mean temperature over a filling technical service.
chamber cycle (250 ms sampling time) Technical defect.
measured at TSD exceeds 41 °C.

13-8 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Alarms and remedial action

Alarm/message/code Cause Remedial action

Temperature too low (code 1033) Irregular dialysate flow.  If alarm cannot be reset, contact
The mean temperature over a filling technical service.
chamber cycle (250 ms sampling time) Technical defect.
measured at TSD was 1 °C lower than
the set value.

Bicarbonate conductivity limit Suction rod not correctly inserted in  Check position of rod in
(code 1028) container. container.
The average value during a filling
chamber cycle (250 ms sampling time) Concentrate container empty.  Replace container.
measured at BICLF deviates by more
than +/-5 % from the preselected value. Defective suction line.  Replace suction line.

Technical defect.  Contact technical service.

Bicarbonate mixing ratio (code 1030) Incorrect concentrate used.  Connect correct concentrate.
The mixing ratio H2O to bicarbonate
concentrate is outside of the +/-7 Incorrect composition of  Where mix is produced on site,
tolerance around the preset ratio. concentrate. observe mixing ratio
powder/water.

Technical defect.  Contact technical service.

Bicarbonate mixing ratio (SUP) Incorrect concentrate used.  Connect correct concentrate.
(code 1950)
The mixing ratio H2O to bicarbonate Incorrect composition of  Where mix is produced on site,
concentrate is outside of the +/-7 concentrate. observe mixing ratio
tolerance around the preset ratio. powder/water.

Technical defect.  Contact technical service.

Final conductivity limit (code 1029) Suction rods not correctly inserted in  Check position of rods in
container.
13
The average value during a filling container.
chamber cycle (250 ms sampling time)
measured at ENDLF deviated by more Concentrate container empty.  Connect new container.
than +/-5 % from the preset value.
Suction line defective.  Replace suction line.

Technical defect.  Contact technical service.

IFU 38910273EN / Rev. 2.11.00 / December 2011 13-9

Alarms and remedial action Dialog+

Alarm/message/code Cause Remedial action

Final conductivity limit (SUP) Suction rods not correctly inserted in  Check position of rods in
(code 1951) container. container.
The average value during a filling
chamber cycle (250 msec. sampling Concentrate container empty.  Connect new container.
time) measured at ENDLF deviates by
more than +5 % from end conductivity Suction line defective.  Replace suction line.
confirmed as ”maximum”, or by more
than -5 % from the level confirmed as Technical defect.  Contact technical service.
”minimum”.

Concentrate mixing ratio (code 1031) Incorrect concentrate used.  Connect correct concentrate.
The mixing ratio H2O plus possibly BIC
concentrate to acetate/acid Concentrate container empty.  Connect new container.
concentrates was outside the permitted
range over two filling chamber cycles. Suction line defective.  Replace suction line.

Technical defect.  Contact technical service.

Bicarbonate cartridge not correctly Bicarbonate cartridge probably not  Check if it fits the holder
connected lanced correctly. correctly.
(code 1018)
The cartridge could not be filled

Malfunction of chamber system Technical defect.  Preparation: Alarm will be cleared

sensors (code 1023) automatically.
The balance chamber sensors (MSBK1;  Therapy: Press the “Reset alarm”
MSBK2) have produced a reading (AQ) button twice in order to
outside the end values determined after remove the alarm condition.
switch-on of the voltage supply for over  If alarm cannot be cleared, try to
restart the device.
13 1.5 min.
 Call a technician.

13-10 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Alarms and remedial action

Alarm/message/code Cause Remedial action

UF balance? Air leakage in dialyser Dialyser not filled without air  Vent dialyser (water side).
couplings (code 1026) inclusions.
During the dialysis, the valve (VLA) had
to be opened more than 20 times due to Dialyser connection leaking.  Check dialyser connections.
air (level below bottom electrode) in the
bubble catcher. Technical defect.  Contact technical service.

DF pressure < –400 mmHg Dialyser UF factor too small for set  Use dialyser with larger UF factor.
(code 1020) UF rate.
The dialysate pressure downstream of
the dialyser (PDA) is below –400 mmHg. Too high UF volume set.  Reduce UF volume/increase UF
time.

Tube kinked.  Check blood tubes.

Technical defect.  Contact technical service.

Dialyser TMP limits exceeded Excessive UF volume/time settings.  Reduce UF volume/increase UF

(code 1017) time.
The TMP (PV-PDA) is larger than the
preset maximum TMP.  Reset TMP limits.

Clotting.  Check heparinisation.

Dialyser factor too small.  Use dialyser with larger factor.

Technical defect.  Contact technical service.

Actual UF volume deviation Technical defect.  Contact technical service.

(code 1816)
The UF volume calculated from the
speed of the UF pump deviates
significantly from the set value. The
limits window can be extended up to
threefold. 13
High UF volume error-terminate Technical defect.  Contact technical service.
dialysis (code 1826)
The UF volume deviates more than
400ml.

UF volume exceeded (SUP) Technical defect.  Contact technical service.

(code 1966)
UF volume has been reached.

IFU 38910273EN / Rev. 2.11.00 / December 2011 13-11

Alarms and remedial action Dialog+

Alarm/message/code Cause Remedial action

Max. UF rate exceeded (SUP) UF volume too high.  Decrease UF volume, increase UF
(code 1953) time
The required UFR is 20 ml/h higher than
the specified max. UFR. Dialyser factor too small.  Use dialyser with higher factor.

Technical defect.  Contact technical service.

Blood Leak (SUP) (code 1955) Rupture in dialyser.  Change dialyser.

Technical defect.  Contact technical service.

Blood leak, sensor dirty (code 1044) Sensor dirty.  Call technical service.
The blood concentration measured at
the sensor (BL) is negative. Air on dialysate-side.  Reset alarm.

Technical defect.  Contact technical service.

+/- 12 V power supply insufficient Technical defect.  Contact technical service.

(code 1008)
Voltage level +12VAN or -12VAN is over
the tolerance.

System restored after power failure Technical defect. The system was  Reestablish power supply.
(code 600) restored.
Power failure during
Preparation/Treatment
Blood recognised in Patient connected in  If self test isn’t ended, disconnect
Preparing/Disinfection Preparing/Disinfection. patient.
The red detector has recognised blood in  If self test is ended, change to
Preparing/Disinfection. Therapy.

Art. bolus vol. > 300 ml (SUP) (code  Please call a technician.
13 2026)
Arterial bolus volume exceeded 300
ml.

13-12 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Alarms and remedial action

13.2.2 ABPM alarms

Alarm/message/code Cause Remedial action

ABPM: Systolic pressure too Systolic pressure exceeds the set  Repeat measurement.
high (code 9100) upper limit.  Select individual limit adjustment.
 Manually change individual limits.
 Inform doctor.

ABPM: Systolic pressure too Systolic pressure is below the set  Repeat measurement.
low (code 9101) limit.  Select individual limit adjustment.
 Manually change individual limits.
 Inform doctor.

ABPM: Diastolic pressure too Diastolic pressure exceeds a set  Repeat measurement.
high (code 9103) upper limit.  Select individual limit adjustment.
 Manually change individual limits.
 Inform doctor.

ABPM: Diastolic pressure too Diastolic pressure drops below a set  Repeat measuring.
low (code 9104) lower limit.  Select individual limit adjustment.
 Manually change individual limits.
 Inform doctor.

ABPM: Internal communication ABPM not operational; no further  Carry out pulse measuring with separate
disturbed (code 9138) measurements possible. RR device, or manually.

ABPM: Pulse rate too high Pulse frequency exceeds upper limit.  Repeat measurement.
(code 9169)  Select individual limit adjustment.
 Manually change individual limits.
 Inform doctor.

ABPM: Pulse rate too low Pulse frequency lower than lower  Repeat measurement.
(code 9170) limit.  Select individual limit adjustment.
 Manually change individual limits.
 Inform doctor.

 Switch dialysis machine off and on

13
ABPM: Module failure please Is displayed after confirmation of
switch off/on (code 9172) alarm 9301. again; all data remain stored.

Blood pressure module has

performed a safety switch-off.

ABPM: Air leak – check cuff Blood pressure module has  Check connections to ABPM and cuff.
connection (code 9300) performed a safety switch-off.  Switch dialysis machine off and on
again; all data remain stored.

ABPM: Module failure please Blood pressure module has  Switch dialysis machine off and on
switch off/on (code 9301) performed a safety switch-off. again; all data remain stored.
Message 9172 remains on the
display after confirmation.

IFU 38910273EN / Rev. 2.11.00 / December 2011 13-13

Alarms and remedial action Dialog+

Alarm/message/code Cause Remedial action

ABPM: Inflation pressure not reached  Check cuff for correct position.
(code 9302)  Re-apply cuff if necessary.
—
 Repeat measurement.

ABPM: Pulsation not detected  Check connections to ABPM and

(code 9303) — cuff.
 Measure pulse manually.
ABPM: Excessive arm movement Excessive arm movement by  Check patient’s arm position.
(code 9304) patient.

ABPM: Systolic BP > max. cuff pressure Considerable increase in blood  Carry out pulse measuring with
(code 9305) pressure since last measurement. separate RR device, or manually.

ABPM: Pulse measurement disturbed  Check cuff for correct position.

(code 9306) —  Carry out pulse measuring with
separate RR device, or manually.

ABPM: Irregular pulse (code 9307)  Check cuff for correct position.
—  Carry out pulse measuring with
separate RR device, or manually.
ABPM: Reading took too long The max. measuring time of 110  Carry out pulse measurement with
(code 9308) seconds is exceeded. separate RR device, or manually.

ABPM: Pulse beat over 100 beats The max. measuring time of 110  Carry out pulse measurement with
(code 9309) seconds is exceeded. separate RR device, or manually.

ABPM: Cuff pressure > 320 mmHg Cuff pressure has exceeded the  Check patient's arm position.
(code 9310) cuff pressure limit.  Carry out pulse measurement with
separate RR device, or manually.

ABPM: Pulse signal very low  Check cuff for correct position.
(code 9311) —  Carry out pulse measurement with
separate RR device, or manually.

13-14 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Alarms and remedial action

13.2.3 Crit-Line alarms

Alarm/Messages/Code Cause Remedial action

HCT is over limit (Dialog) (code 930) UF rate or volume too high.  Reduce UF rate or volume
 Adapt limit at the Dialog
Limit at the Dialog too low.
HCT reading failed Crit-Line device is switched off.  Check Crit-Line device and
(code 931) connection to Dialog
Connection disturbed.  Call technician if necessary
Technical defect.
No blood detected in Crit-Line Sensor not placed correctly at  Check sensor and blood chamber
(code 932) blood chamber.  Call technician if necessary
Sensor obstruction in Crit-Line Foreign material/dirt between  Check/clean sensor or remove
(code 933) sensor and blood chamber. material
 Call technician if necessary
SAT is under limit (code 935) Patient O2 undersupply  Call doctor
 Adapt limit
limit is too high.
HCT is over limit (Dialog) UF rate or volume too high.  Reduce UF rate or volume
(code 940)  Adapt limit at the Dialog
Limit at the Dialog too low.
HCT reading failed Crit-Line device is switched off.  Check Crit-Line device and
(code 941) connection to Dialog
Connection disturbed.  Call technician if necessary
Technical defect.
Crit-Line communication failed Crit-Line not switched on.  Check Crit-Line device and
(code 942) connection to Dialog
Connection disturbed.  Call technician if necessary
Technical defect.
Please initiate Crit-Line monitor! Crit-Line measurement not  Start Crit-Line measurement
(code 943) started.
HCT is over limit (Crit-Line) UF rate or volume too high.  Reduce UF rate or volume
(code 944)  Adapt limit at Crit-Line monitor
Limit at the Crit-Line monitor
too low.
Set/check HCT limit!  Set value or confirm
(code 945)
HCT limit not set or default not
confirmed. 13
SAT is under limit Patient O2 undersupply  Call doctor
(code 946)  Adapt limit
limit is too high.

IFU 38910273EN / Rev. 2.11.00 / December 2011 13-15

Alarms and remedial action Dialog+

13.2.4 Level regulation alarms

Alarm/message/code Cause Remedial action

Volume limit level regulation Max. blood volume exceeds 190 ml.  Check for tubing leaks
(code 1011)
Timeout level regulation Level regulation period is limited to  Set level in less than 3 minutes
(code 1024) 3 minutes.
Blood pump is running Blood pump must not run in  Stop blood pump
(code 2028) Emptying Dialyser or when SAD-
alarm-resolving is active.
Volume limit level regulation Max. blood volume exceeds 220 ml.  Check for tubing leaks
(code 2039)
Arterial pressure monitoring error Insufficient arterial pressure  Set levels correctly
(code 2041) pulsation.  Ensure that hydrophobic filters are
fluid free
Valve position level regulation Wrong valve position.  Contact technician
(code 2042)
Venous pressure monitoring error Insufficient venous pressure  Set levels correctly
(code 2043) pulsation.
PBE pressure monitoring error Insufficient PBE pressure pulsation.  Set levels correctly
(code 2044)  Ensure that hydrophobic filters are
fluid-free
PBS pressure monitoring error Insufficient PBS pressure pulsation.  Ensure that hydrophobic filters are
(code 2045) fluid-free

13-16 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Alarms and remedial action

13.2.5 Adimea alarms

Alarm/message/code Cause Remedial action

Adimea: Target Kt/V will not be The planned Kt/V value will not be  Adapt treatment parameters (time,
reached (code 1550) reached until the end of the blood flow, dialysate flow) to reach
target value or switch of target
treatment.
warning on main screen.
Adimea: Sensor not calibrated This message is shown in Therapy  The sensor will work properly after
(code 1551) when: machine switch off/on.
Sensor calibration has not been  If the condition repeats more than
two or three times call technician.
successful during Preparation.
Unstable signal at therapy start
most probably due to patient
related factors, i.e. problems on
vascular access
Communication failure between
machine and sensor during
Therapy.
Successive failures during
measurement most probably
because of air bubbles in the
dialysate fluid.
Adimea: Sensor not connected Sensor is not present.  Call technician
(code 1552)
Physical interruption or
electromagnetic disturbances on
the USB communication interface.
Adimea: Calibration failed Problems during self calibration  The machine offers the option to
(code 1553) stage, most probably due to air repeat the calibration procedure in
case of failure.
bubbles in dialysate fluid.
Adimea: Sensor cannot warm up The photodiodes of the sensor are  Call technician
(code 1554) defective.
Sensor cannot warm up during
calibration, full accuracy is not 13
achieved.
Sensor cannot warm up at least
10 times when actively measuring
during therapy. In this case, the
sensor is disabled because
measurement accuracy cannot be
guaranteed.
Adimea: Sensor is disabled Accuracy of sensor is not fully  Call technician
(code 1555) reached.
Sensor was disabled during
therapy because of warming up
problems.

IFU 38910273EN / Rev. 2.11.00 / December 2011 13-17

Alarms and remedial action Dialog+

13.2.6 bioLogic RR® Comfort alarms

Alarm/message/code Cause Remedial action

bioL. RR® UF volume cannot be 80 % weight loss was not achieved  Acknowledge at any time
reached (code 3000) at 80 % of treatment time with unconditionally.
 Press bioLogic RR® button. Alarm
50 ml tolerance.
disappears automatically.
bioL. RR® 3 or more missing 13 minutes without successful  Acknowledge the alarm twice in
readings (code 3001) blood pressure measurement since order to trigger a new blood pressure
measurement. Alarm disappears
the request of bioLogic RR®
automatically if a successful
algorithm. measurement is performed.
 Press bioLogic RR® button. Alarm
disappears automatically.
bioL. RR® Internal error Internal error occurred in bioLogic  Press bioLogic RR® button. Alarm
(code 3002) RR®. disappears automatically.
bioL. RR® No reading request The time between two blood  Press bioLogic RR® button. Alarm
(code 3003) pressure reading requests is more disappears automatically.
than the time limit.
bioL. RR UF volume may not be 70 % weight loss was not achieved  Press bioLogic RR® button. Alarm
reached (code 3100) at 70 % of treatment time with disappears automatically.
50 ml tolerance.
bioL. RR UF profile cancelled UF profile was set before bioLogic  Press bioLogic RR® button. Alarm
(code 3101) RR® button was pressed. disappears automatically. bioLogic
RR® sets the profile.
Set UF profile is cancelled.

bioL. RR SYS Lower Limit Max. SYS Lower Limit of 130 mmHg  Press bioLogic RR® button.
reduced (code 3102) exceeded (value 130 mmHg is valid  Reduce SYS Lower Limit to max.
130 mmHg.
for bioLogic RR®).
bioL. RR Missing reading 3 minutes without successful blood  Press bioLogic RR® button. Alarm
(code 3103) pressure reading since the request disappears automatically.
of bioLogic RR® algorithm.

13-18 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Alarms and remedial action

13.2.7 Online alarms

Alarm/message/code Cause Remedial action

Open Subst-port (white) Substitution port(s) is/are closed.  Open substitution port(s) outlet for
(code 1056) filter draining in order to aerate the
filter.
Substitution port outlet open Substitution port outlet is open.  Close outlet port.
(code 1078)  If the port is closed and the alarm is
still displayed, call technician.
Substitution port outlet closed Substitution port outlet is  Open outlet port.
(code 1079) closed.  If the port is opened and the alarm
is still displayed, call technician.
Substitution port inlet open Substitution inlet port open.  Close inlet port.
(code 1080)  If the port is closed and the alarm is
still displayed, call technician.
Substitution port inlet closed Substitution inlet port closed.  Open inlet port.
(code 1081)  If the port is opened and the alarm
is still displayed, call technician.
Pump cover open (substitution) Pump cover is open.  Close cover.
(code 1093)
Start without self test (SUP) Self tests have not been done.  Press AQ button twice.
(code 1969)  Switch off/on device.
 If alarm persists, call technician.
HDF alarm has blood pump stopped Blood pump was stopped due to  Check substitution hardware.
(SUP) (code 1977) HDF alarm.  Switch off/on substitution.
 If necessary, call technician.
Leakage in the Subst. system (SUP) Leakage in the substitution  Check the substitution system
(code 1993) system.  If necessary, switch off HDF.
UF volume too high (SUP) Deviation of HDF too high.  The limit values can be extended
(code 1994) with the Enter button.
 If necessary switch off HDF.
UF rate too high (SUP) (code 1996) It is no longer possible to  Switch off HDF.
increase limit value extension.  Check patient weight.
UF rate too low (SUP) (code 1997) UF rate too low.  Switch off HDF.
 Check patient weight.
HDFO: Bolus volume too high (SUP) Supervisor detected too high  Press ”Reset alarm” button to reset.
(code 2016) If not possible call technician.
bolus volume.
 Disconnect patient. 13
Check substitution line for tightness Substitution line not properly  Check substitution line correct
(code 2017) connected. connection.
 Check substitution line for leakage.
Leakage.
HDF test failed (SUP) (code 2018) Supervisor detected too high  Press “Reset alarm” button to reset.
bolus rate.  If not possible, call technician.
HDFO: OSP activated (SUP) Technical defect.  Press ”Reset alarm” button to reset.
(code 2020) If not possible, call technician.
Online substitution pump (OSP)  Disconnect patient.
rotates when dialyser inlet valve
(VDE)/dialyser outlet valve (VDA)
is closed.

IFU 38910273EN / Rev. 2.11.00 / December 2011 13-19

Alarms and remedial action Dialog+

Alarm/message/code Cause Remedial action

HDFO: VSB or VSAA opened (SUP) Technical defect.  Press ”Reset alarm” button to reset.
(code 2021) If not possible, call technician.
Substitution connection outlet  Disconnect patient.
 Make a disinfection.
valve (VSAA) is open.
HDFO: VBE opened (SUP) Technical defect.  Press ”Reset alarm” button to reset.
(code 2022) If not possible, call technician.
Filter vent valve (VBE) is open.  Disconnect patient.
Online dialysis not possible.
HDFO: DF system not rinsed (SUP) Technical defect.  Press “Reset alarm” button to reset.
(code 2023) If not possible, call technician.
Water part not rinsed after  Disconnect patient.
disinfection.
HDF Inf. bolus volume too high Supervisor detected too high  Press “Reset alarm” button to reset.
(SUP) (code 2030) bolus rate. If not possible, call technician.
 Disconnect patient.
Ratio gross UF/blood flow too low UF rate exceeds a defined  Increase blood flow.
(code 2059) percentage of the blood flow.  Reduce substitution flow.
HDF/UF alarm limits expanded Any of the UF TLC or LLS alarm  Leave Therapy or End of Therapy.
(code 2070) limits have been expanded.

13-20 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Alarms and remedial action

13.3 Remedying SAD alarms

In case of air in the area of the SAD, the tube clamp (SAKV) is closed due to the alarm
action. Due to the reaction time of the system, a small amount of air could be below
the SAD, too, in case of SAD alarms.

For removing the air, a note is displayed on the screen.

Check that all connections are tight.
If the alarm was triggered by micro foam, it is sufficient to reset the alarm. The reset
deletes the alarm not before 2 s after switching off the alarm tone. The measuring
region of the SAD must now be free of air bubbles.

Removing air bubbles (if level regulation system is present)

If air bubbles in the venous line have triggered the alarm, these bubbles must be
removed as follows:
 Clamp tube between venous bubble catcher and dialyser.
 Press Enter key on the monitor to open the window “increase venous level”.
 To increase the venous level press the “increase venous level” icon.
 When the air has been removed, open clamp between venous bubble catcher and
dialyser and press the key “Reset alarm”.

Removing air bubbles (if level regulation system is not present)

If air bubbles in the venous line have triggered the alarm, these bubbles must be
removed as follows:
 Clamp tube between venous bubble catcher and dialyser.
This prevents blood from being sucked from the dialyser.
 Using a syringe, create a vacuum of at least -75 mmHg at the venous air bubble
13
catcher, see venous pressure display.
As the air is located in the region of the patient inlet, it must be moved back to the
venous bubble catcher by this vacuum action.
 Press Enter key on monitor.
Venous clamp opens briefly.
Blood flows back from the patient inlet and the air is moved into the venous bubble
catcher.
 Remove clamp between venous bubble catcher and dialyser.
 Once the air has been removed, press ”Reset alarm” button on monitor. Repeat
procedure if necessary.
Once all air has been removed from the SAD, the alarm is deleted. If some air
remains in that region, the process must be repeated.

IFU 38910273EN / Rev. 2.11.00 / December 2011 13-21

Alarms and remedial action Dialog+

13.4 Manual blood return

In case of a power failure during dialysis and where no emergency power supply is
available, the blood must be returned manually to the patient.

Risk to the patient!

 During manual blood return, no air infusion monitoring functions are active in
the dialysis machine. Staff have to monitor both the patient and the dialysis
machine.
WARNING  Always carry out the manual blood return by two persons and with the utmost
care.
 Always turn blood pump clockwise indicated by arrows on the roller rotor.

The crank for manual blood return may be one of two alternatives (see following
pictures).

Fig. 13-2 Use of crank (alternative 1)

Observe, using the crank on the picture above, to insert it in the external hole to ease
the manual rotation.

13-22 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Alarms and remedial action

Fig. 13-3 Use of crank (alternative 2)

 Remove crank from rear of dialysis machine.

 Open (left) blood pump lid and insert crank into the roller rotor.
 Disconnect arterial side from patient, see section 6.1.
 Remove venous line from the SAKV.
 Evenly operate the blood pump using the crank. Observe appropriate speed and
maintain an adequate blood level in the venous bubble catcher.
 Continue to monitor venous patient inlet, which may not contain any air.
 When the physiological saline solution reaches the venous tube clamp, close the
clamp.
 Disconnect the patient on the venous side.

IFU 38910273EN / Rev. 2.11.00 / December 2011 13-23

Alarms and remedial action Dialog+

13.5 Omission of acoustic signals

13.5.1 Omission of acoustic signals for alarm

The sounds are omitted for the following alarms:

ID Text
600 System restored

13.5.2 Omission of acoustic signals for advice

The sounds are omitted for the following advices:

ID Text
1900 The selected interval is over
1903 Selected UF volume too high
1904 Selected UF volume too low
1905 Selected UF time too high
1906 Selected UF time too low
1907 Interval cannot be modified
1908 Max. UF ratio has profile modified
1911 Selected Heparin rate too high
1912 Selected Heparin rate too low
1922 UF volume has been decreased
1934 Rinsing time too long
1935 Rinsing time too short
1936 UF rinsing volume too high
1937 UF rinsing volume too low
1942 Acknowledge data before connecting patient
2056 No Heparin bolus
2060 Please press longer EQ button again
2066 UF + HDF rate > 5500 ml/h please reduce!
13 2073 Rinsing rate too low
2074 Rinsing rate too high
1093 Pump cover open (substitution)
1054 Preparation of new Bic Cartridge-bypass

13-24 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Accessories

Table of contents

14 Accessories ......................................................................................... 14-3

14.1 Options ................................................................................................ 14-3
14.2 Mechanical accessories...................................................................... 14-4
14.3 Other accessories................................................................................ 14-4

IFU 38910273EN / Rev. 2.11.00 / December 2011 14-1

Accessories Dialog+

14-2 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Accessories

14 Accessories

14.1 Options

Name Article no. (REF)

Nexadia® – BSL: Card reader and networking device* 7102230

ABPM: Automatic blood pressure monitoring 7102226

bioLogic RR® Comfort for card reader: Automatic blood pressure 7105324
stabilisation with template method (only with option ABPM)
Bicarbonate cartridge holder 7105171

Sample port dialysat 7102867

Emergency power supply (Accu) 7102244

Central concentrate supply (CCS) 7105196

DF filter 7102102

Staff call* 7102315

Roller rotor for pump segment 7x10 7102340

DCI* (Dialog+ Communication Interface) 7107218

Connection line for electrical ground 8701628

Adimea 7102233

Crit-Line Interface 7106604

Crit-Line Potential Equalisation Kit 7106605

Card reader incl. 5 cards 7105230

14
* Because of defined cable length the marked items are only allowed to be used in
order to meet the standard according to EMC (electromagnetic compatibility)
directive.

IFU 38910273EN / Rev. 2.11.00 / December 2011 14-3

Accessories Dialog+

14.2 Mechanical accessories

Name Article no.

Dialyser holder 7107426

Box Comfort 7107302

Box 7107320

Plain universal storage 7102890

Monitor storage 7102872

Protocol storage 7102873

ABPM: Small cuff, latex-free 7102372

ABPM: Medium cuff, latex-free 7102771

ABPM: Large cuff, latex-free 7102380

Universal base storage (max. 30 kg, e.g. single bed - RO unit) 7105500

Holder for 6-liter disinfectant containers 7107275

Holder for 10-liter disinfectant containers 7107277

Dialog+ patient therapy card (set with 5 pieces) 7105232

Cuff basket 7102865

Cuff holder 7102781

Rinse bucket 7105237

14.3 Other accessories

14 B. Braun currently offers accessories from the following product areas:
• Dialysers with polysulfone membrane for high and low flux
• Haemofilters
• AV systems
• Dialysis concentrates and bicarbonate powder cartridges
• Fistula cannulas
• Rinsing solutions
• Haemofiltration solutions
• Disinfectants
For further information please contact your B. Braun representative.

14-4 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Technical data

Table of contents

15 Technical data.................................................................................... 15-3

IFU 38910273EN / Rev. 2.11.00 / December 2011 15-1

Technical data Dialog+

15-2 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Technical data

15 Technical data

15.1 General technical data

Description Values

Nominal voltage 120 V ± 10 %

230 V ± 10 %
Nominal frequency 120 V ~/ 230 V~ ± 5 %
50 Hz / 60 Hz ± 5 %
Nominal current 16 A at 120 V
max. 11 A at 230 V
Connected load 1.92 kW at 120 V
2.5 kW at 230 V
Mains cord

Current-voltage-rating 20 A at 120 V
16 A at 230 V
Minimum cross section of 3.3 mm2 (AWG12) for 120 V 1.5 mm2 for 230 V
single strand
Withstand voltage of single min. 2 kV, 50 Hz, ≥1 min
strand (L-N, L-PN, N-PE)
Average energy consumption approx. 1.5 kW/h

Heat emission approx. 230 W/h

Categorisation II b according to EC Directive for Medical Devices 93/42/EEC

Classification Type B, IEC 60601-1

Device leakage current < 500 µA

Patient leakage current < 10 µA

Protection class IP21 (Protection against foreign bodies > 12 mm and vertically
falling drip water)
DIN EN 60529
Electrical ground via optional cable 15
Dimensions (W × H × D) approx. 510 × 1678 × 637 mm

Housing material Aluminum, corrosion-proof

Empty weight approx. 85 kg

IFU 38910273EN / Rev. 2.11.00 / December 2011 15-3

Technical data Dialog+

Description Values

Water supply Water suitable for dialysis

Pressure range 0.5 – 6 bar

Water inlet temperature for 10 – 30°C

dialysate preparation
Water inlet temperature for max. 95°C
disinfection
Alarm ”No water” from separate monitoring device

Concentrate supply from container or central supply 0 – 1 bar

For information regarding fuse ratings and battery specifications please refer to
service manual.

15.2 Ambient conditions

Description Values

Operation

Temperature +10 to +40 °C

Relative humidity 15 % – 70 %

Atmospheric pressure 700 – 1060 mbar

Transportation and storage (dry)

Temperature -20 to +60 °C

Relative humidity 15 % – 80 %

Atmospheric pressure 700 – 1060 mbar

15-4 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Technical data

15.3 Recommended safe distances

Recommended safe distances in meter (m) between portable or mobile HF telecommunication

devices and the Dialog+ dialysis machine

The dialysis machine Dialog+ is made for the use in ambient conditions with controlled High-
Frequency disturbance variables. The user can avoid electromagnetic disturbances by keeping
the distance between Dialog+ and HF-telecommunication devices following the values in the
table below in dependency to the output power of those devices.
Nominal output P of Safe distance (d) depending on transmitting frequency
transmitter
(Watt)

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
d = 1.2 P d = 1.2 P d = 2.33 P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.20 1.20 2.30
10 3.80 3.80 7.30
100 12 12 23

For transmitters with other output power ratings, the recommended safety distance
(m) can be calculated with the above formulas. Heed the max. power rating (W), in
accordance to the manufacturer’s information, to use the formula from above.
Remark 1: For 80 MHz and 800 MHz use the higher frequency range.
Remark 2: This guideline may be not practicable in some cases. The propagation of
electromagnetic quantity will be influenced by adsorption and reflexion of the
building, equipment and human.

Find more information about electromagnetic compatibility (EMC), radio disturbance

and IEC 60601-1-2 in the service manual, chapter 8.

IFU 38910273EN / Rev. 2.11.00 / December 2011 15-5

Technical data Dialog+

15.4 Dialysate system

Description Values

Temperature setting range 33 – 40 °C

Temperature tolerance at +0.5°C to -1.5°C

standard ambient
temperature
Limits ± 1 °C (of set specified value)

Excessive-temperature 41 °C
protection
Protection system Temperature sensor

Bridging time of protection Cannot be bridged during dialysis

system
Deactivation of acoustic 120 s
alarm
Heating power 1800 W

Conditioning Conductivity regulated

Operating regime Conductivity bicarbonate 2 – 4 mS/cm, 4 – 7 mS/cm

Overall conductivity 12.5 – 16.0 mS/cm
Tolerance ±0.2 mS/cm

Measurement Temperature-compensated (reference temperature 25 °C)

Protection system Monitoring through second conductivity sensor with different

geometry

Limit ±5 % (of set value)

Bridging time of protection cannot be bridged during dialysis

system

Deactivation of acoustic 180 s

alarm
15 Flow 300 – 800 ml/min

DF tolerance at dialysis ±5 % (of specified value) at 300 - 800 ml/min

machine
Bridging time of protection Not bridgeable via balance chamber filling times during
system dialysis
Deactivation of acoustic 300 s
alarm

15-6 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Technical data

Description Values

Dialysate pressure range area +400 to –450 mmHg

Tolerance (PDA) ±10 mmHg

Upper limit +400 mmHg

Lower limit –450 mmHg

Deactivation of acoustic alarm 120 s

Blood leak detector Red sensitive

Tolerance 10 %

Alarm threshold >0.5 ml/min blood at HKT 45 %

>0.35 ml/min blood at HKT 25 % (AAMI)
Bridging time Not bridgeable during dialysis

Deactivation of acoustic alarm 120 s

Ultrafiltration Volume-controlled via balance chambers, ultrafiltration through

ultrafiltration pump
Sequential ultrafiltration (Bergström)
Operating range 0– 4000 ml/h

Overall accuracy * F = Fbal + FUF

Fbal ± 0.2 ml/chamber cycle

FUF Ultrafiltration pump tolerance <1 %

Protection system Speed monitoring of UF pump with an accuracy of <1 %;

System will alarm 200 ml beyond given value or 10 % beyond preset
UF rate.
Bridging time of protection Not bridgeable during dialysis
system
Deactivation of acoustic alarm 120 s

15
* The overall accuracy F is the sum of two different errors:
F = Fbal +FUF
Fbal = balance chamber deviation (measures per chamber cycles and depends on the
dialysate flow)
FUF = UF pump error

IFU 38910273EN / Rev. 2.11.00 / December 2011 15-7

Technical data Dialog+

Description Values

Trans membrane pressure

Limit range (max. TMP) 300 – 700 mmHg

Absolute alarm limit -100 mmHg

Limit window adjustable (2 % - 99 %)

Tolerance Calculated through PBE, PDA and PV

Bridging time of protection Not bridgeable during dialysis

system
Deactivation of acoustic alarm 120 s
Degassing system Mechanically regulated through the degassing valve and the
degassing pump
Tolerance ± 50 mmHg

Disinfection
During disinfection processes dialysis is blocked.
Reports on the effectiveness of the individual disinfection programs can be obtained from the
manufacturer
Disinfection/cleaning Automatic program with enforced rinse-out
The parameters for the disinfectant used can be set in the service
program.
HDF-online and dialysis fluid filter option: Only disinfectants
cleared for the dialysis fluid filter can be used.
Thermal disinfection Automatic program cycle at approx. 85 °C at the dialyser
couplings

15-8 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Technical data

15.5 Extracorporeal circulation

Description Values

Blood pump 2-roller pump with automatic motor switch-off when lid is
opened, backstop, low haemolysis.
For 8/12 mm or (optional) 7/10 mm pump tubes
Pumping rate 50 – 600 ml/min (8/12 mm)
50 - 400 ml/min (7/10 mm)
Adjustable in 10 ml steps
Tolerance interval < 10 % for blood pressure up to -150 mmHg
Tolerance between 10% and 25% for blood pressure up to -200
mmHG
Working pressure range Intake pressure up to –390 mm Hg
Pumping pressure 0 – 1725 mm Hg
Heparin pump Syringe pump for 10 – 30 ml syringes

Pumping rate 0.1 – 10 ml/h in steps of 0.5 ml/h or 0.1 ml/h, can be turned off,
bolus: 600 ml/h
Tolerance interval < ±10 %

Pressure range 0 to +480 mmHg

Safety air detector SAD (Safety air detector), based on ultrasound

Sensitivity Air bubbles at > 50 µl, micro foam with cumulated volume
Limit values double-needle:
0.2 ml at 0 – 200 ml/min SAD flow
0.3 ml at 200 – 400 ml/min SAD flow
0.5 ml at > 400 ml/min SAD flow
Limit values single-needle:
0.7 ml at 1200 ml/min constant SAD flow
Protection system Ultrasound detector, automatic cyclical checks during entire
operating phase
Bridging time of protective Not bridgeable during dialysis
system only in end phase for approx. 30 ml (has to be activated at TSM)
Red sensor in SAD housing
15
Function Detects blood in tube system

Modes of operation 1st mode of operation: The blood pump is stopped as soon as the
red sensor detects blood when connected at this site.  Alarm
caused
2nd mode of operation: If the red sensor detects blood at this
point, a heparin bolus is administered. This function can be
disabled by technical service in the service program.
3rd mode of operation: If no blood is detected at this site in the
End Therapy mode, the blood pump is stopped.
4th mode of operation: If blood is detected during preparation or
disinfection, the blood pump is stopped  Alarm caused

IFU 38910273EN / Rev. 2.11.00 / December 2011 15-9

Technical data Dialog+

Description Values

Pressure measurement at Electronic pressure sensor

arterial inlet of dialyser
(PBE)
Operating range 0 – 700 mmHg

Tolerance interval ±10 mmHg

Limit Adjustable within operating range

Protection system Test prior to start of therapy

Arterial inlet pressure (PA) Electronic pressure sensor with digital quasi-analogue display
measurement
Operating range –400 to +400 mmHg

Tolerance ±10 mmHg

Limit –400 to +400 mmHg

adjustable within operating range, adjustable interval width for
dynamic limits window
Protection system Electronic pressure sensor, test prior to start of therapy

Deactivation of acoustic 120 s

alarm
Venous return pressure (PV) Electronic pressure sensor with digital quasi-analogue display
measurement
Operating range 20 – 390 mmHg (adjustable in service program)

Tolerance ±10 mmHg

Limit Alarm window around operating value

Configurable alarm window (20–200 mmHg)
After blood pump adjustment, the alarm window is re-centred.
Protection system Test prior to start of therapy
Venous window of 20 – 390 mmHg. Venous limits are monitored
by the function and control systems.

15 Bridging time of protection Not bridgeable during dialysis

system
Deactivation of acoustic 120 s
alarm

15-10 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Technical data

15.6 Materials coming into contact with water, dialysate, dialysis

concentrates and/or disinfectants

Material name Abbreviation if existent

Ceramics

Ethylene Propylene Diene Monomer EPDM

Glass

Graphite

Polyester

Polyetheretherketone PEEK

Polyetherimid PEI

Polyethylene PE

Polyisoprene

Polymethylmethacrylate PMMA

Polyoxymethylene POM

Polyphenylsulfone PPSU

Polypropylene PP

Polypropylene Oxide PPO

Polytetrafluoroethylene PTFE

Polyvenyl Chloride PVC

Polyvinylidene difluoride PVDF

Silicone
15
Stainless steel

Thermoplastic Urethane TPU

IFU 38910273EN / Rev. 2.11.00 / December 2011 15-11

Technical data Dialog+

15.7 Technical data HDF/HF-online

Description Values

HDF (Haemodiafiltration)

Substitution rate 20 – 400 ml/min ±10 %

Dialysate processing 500 – 800 ml/min ±10 %

Infusion bolus 50 – 250 ml ±10 %

HF (Haemofiltration)

Substitution rate 20 – 400 ml/min ±10 %

Infusion bolus 50 – 250 ml ±10 %

Online filter

Operating time 150 treatments (900 h), see filter instructions for use

15-12 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Technical data

15.8 ABPM blood pressure monitoring

Description Values

Cuff pressure range 0 – 320 mmHg

Inflation pressure during first 200 mmHg

cuff inflation
Inflation pressure during Last SYS pressure +30 mmHg
subsequent measurements
Blood pressure measurement Systole 45 - 280 mmHg
range MAP 25 - 240 mmHg
Diastole 15 - 220 mmHg
Accuracy ±3 mmHg or ±2 %

Blood pressure determination Typical 25 sec.

time (Adult with blood pressure 120/80 and 80 BPM)
Pulse rate determination 30 – 240 BPM

Pulse rate accuracy ±2 % or 2 BPM

Overpressure cut-off 300 mmHg +10 %

Time of alarm suppression <1s

Deactivation of acoustic alarm 120 s

Defibrillation Protected applied part

Safety class Safety class I, Type BF

IFU 38910273EN / Rev. 2.11.00 / December 2011 15-13

Technical data Dialog+

15.9 Technical data of Crit-Line interface

The intended use of the DSI interface is to connect the Crit-Line III TQA device of
Hema Metrics™ to the Dialog+ or other devices released by B. Braun for operation.
It is prohibited to connect any other device.

The DSI interface is galvanically isolated from the Dialog+/staff/patient according to

the standard IEC 60601-1.

Description Values

Maximum specific transfer rate 115.2 KBaud

Maximum voltage level (all pins in relation to GND (ground)-level) ±25 VDC

Maximum ohmic impedance of external serial connection cable 7 KΩ

Maximum capacitive impedance of external serial connection cable 2500 pF

15-14 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Appendix

Table of contents

IFU 38910273EN / Rev. 2.11.00 / December 2011 16-1

Appendix Dialog+

16-2 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Appendix

16 Appendix

16.1 Flow diagrams

16.1.1 Key to flow diagrams

Symbol Abbreviation Description

BICLF Bicarbonate conductivity sensor

ENDLF END conductivity sensor
ENDLF-S END conductivity sensor supervisor

BICP Bicarbonate concentrate pump

BPA Arterial blood pump
BPV Venous blood pump

BICSS Bicarbonate rinsing connection sensor

KSS Concentrate rinsing connection sensor
BK1 Balance chamber 1
MSBK1 Membrane position sensor balance chamber 1
BK2 Balance chamber 2
MSBK2 Membrane position sensor balance chamber 2

BL Blood leak detector

BVA Bicarbonate supply connection

KVA Concentrate supply connection
DDE Dialyser inlet check valve
RVDA Dialysate check valve
RVFPA Flow pump outlet check valve
RVFPE Flow pump inlet check valve

DMV Pressure reduction valve

EP Degassing pump
FPE Inlet flow pump
FPA Outlet flow pump

Water block with integrated upline tank, level

WA sensor, double-stage heater, heat exchanger and
degassing chamber

PA
PBE
Arterial pressure sensor
Blood inlet pressure sensor 16
PBS Blood control pressure sensor
PDA Dialysate outlet pressure sensor
PE Degassing pressure sensor
PV Venous pressure sensor

VEB Degassing bypass valve

IFU 38910273EN / Rev. 2.11.00 / December 2011 16-3

Appendix Dialog+

Symbol Abbreviation Description

DBK Bicarbonate cartridge throttle

VABK1/2, VBE,
VBICP, VBKO,
VBKS, VBP,
VDA,
VDABK1/2,
Solenoid valve
VDE,
VDEBK1/2,
VEBK1/2, VLA,
VSAE, VSB,
VVB, VVBE, VZ

TSE Degassing temperature sensor

TSHE Heater inlet temperature sensor
TSH Thermal fuse heater
TSBIC Bicarbonate temperature sensor
TSD Dialysate temperature sensor
TSD_S Dialysate temperature sensor supervisor

RVB Bicarbonate check valve

RVBO Top bicarbonate check valve
RVBU Bottom bicarbonate check valve
RVK Concentrate check valve

16-4 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Appendix

16.1.2 Flow diagram Dialog+

IFU 38910273EN / Rev. 2.11.00 / December 2011 16-5

Appendix Dialog+

16.1.3 Flow diagram Dialog+ HDF-online

16-6 IFU 38910273EN / Rev. 2.11.00 / December 2011

Dialog+ Appendix

16.2 Technical safety inspection and preventive maintenance

The technical safety inspection shall be performed and documented every 12 months
according to the specified check list in the service manual and with reference to the
instructions for use.
The preventive maintenance is recommended every 12 months according to the
specified check list in the service manual and with reference to the instructions for
use.

IFU 38910273EN / Rev. 2.11.00 / December 2011 16-7

Appendix Dialog+

16-8 IFU 38910273EN / Rev. 2.11.00 / December 2011

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