B.Braun Dialog+ User manual
Dialog
+
®
Instructions for Use SW 9.1x
Dialysis Machine
CE marking according to directive 93/42/EEC
Technical alterations reserved Manufacturer:
B. Braun Avitum AG
Rx only
34209 Melsungen, Germany
Tel +49 (56 61) 71-3716
Fax +49 (56 61) 75-3716
RTD.IM01 04/05
IFU 38910363US /Rev. 2.15.10 / May 2016
US Distributor:
B. Braun Medical Inc.
Avitum Division
Bethlehem, PA 18018-3524, USA
Made in Germany
Tel 1-800-621-0445
Fax (610) 691-1547
Dialog+® Table of contents
1 Safe handling
2 Product description
3 Installation and commissioning
4 Therapy types
5 Preparing for hemodialysis
6 Initiating hemodialysis
7 Ending hemodialysis therapy
8 Disinfection
9 Single-needle procedure
1
2
3
4
5
6
7
8
9
10 Use of options
11 Configuration
12 Maintenance and cleaning
13 Alarms and remedial action
14 Accessories
15 Technical data
16 Appendix
10
11
12
13
14
15
16
Table of contents Dialog+®
II IFU 38910363US / Rev. 2.15.10 / May 2016
Dialog+® Table of contents
Table of contents
1 Safe handling ..........................................................................................1-3
1.1 Intended use and indications .............................................................. 1-3
1.2 Contraindications ................................................................................. 1-3
1.3 Side effects...........................................................................................1-3
1.4 About these Instructions for Use........................................................ 1-4
1.4.1 Applicability................................................................................................1-4
1.4.2 Target group...............................................................................................1-4
1.4.3 Warnings, notices and symbols in these Instructions for Use.....1-4
1.4.4 Abbreviations.............................................................................................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 interaction..................................................................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 User requirements.....................................................................................1-8
1.6.3 Conformity..................................................................................................1-8
1.6.4 Manufacturer’s warranty........................................................................1-9
1.6.5 Technical changes.....................................................................................1-9
1.7 Disposal.................................................................................................. 1-9
2 Product description ................................................................................ 2-3
2.1 Components ..........................................................................................2-4
2.1.1 Extracorporeal system .............................................................................2-4
2.1.2 Dialyzer........................................................................................................2-4
2.1.3 User interface.............................................................................................2-4
2.1.4 Control system...........................................................................................2-5
2.1.5 Balance chamber and UF-control.........................................................2-5
2.1.6 Water preparation ....................................................................................2-5
2.1.7 Concentrate preparation.........................................................................2-5
2.2 Basic models.......................................................................................... 2-6
2.2.1 Dialog+single-pump machine...............................................................2-9
2.3 Symbols on the dialysis machine......................................................2-10
2.4 Control elements and information on the monitor........................2-11
2.5 Overview of all icons..........................................................................2-13
2.6 Entering numerical values.................................................................2-20
2.7 Using the timer/stop watch...............................................................2-23
3 Installation and commissioning.............................................................3-3
IFU 38910363US / Rev. 2.15.10 / May 2016 III
Table of contents Dialog+®
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 Rolling..........................................................................................................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 Therapy types...........................................................................................4-3
4.1 Hemodialysis (HD)................................................................................ 4-3
4.2 Phases of pure ultrafiltration ............................................................. 4-3
4.3 Methods of treatment......................................................................... 4-4
4.3.1 Double-needle procedure .......................................................................4-4
4.3.2 Single-needle procedure.........................................................................4-4
4.4 Effectiveness of dialysis (Kt/V)........................................................... 4-5
5 Preparing for hemodialysis.....................................................................5-3
5.1 Initiating hemodialysis......................................................................... 5-4
5.2 Automatic test...................................................................................... 5-4
5.2.1 Operation during automatic test..........................................................5-5
5.2.2 Terminating the automatic test sequence.........................................5-6
5.2.3 Completion of automatic test sequence............................................5-6
5.3 Reducing the warning sounds during preparation............................ 5-6
5.4 Connecting the concentrate ............................................................... 5-8
5.5 Setting the rinsing parameters........................................................... 5-9
5.6 Inserting, rinsing and testing the tubing system............................5-11
5.6.1 Inserting standard A/V tubing............................................................5-12
5.6.2 Rinsing and testing standard A/V tubing........................................5-14
5.6.3 Level regulation during Preparation (if present)...........................5-14
5.6.4 Inserting Streamline® bloodline ........................................................5-16
5.6.5 Rinsing and testing the tubing system............................................5-17
5.7 Preparing the heparin pump .............................................................5-18
5.7.1 Inserting the heparin syringe..............................................................5-18
5.7.2 Venting the heparin line......................................................................5-19
IV IFU 38910363US / Rev. 2.15.10 / May 2016
Dialog+® Table of contents
5.8 Setting the treatment parameters...................................................5-20
5.8.1 Setting the dialysate parameters ......................................................5-21
5.8.2 Monitoring the dialysate.....................................................................5-24
5.8.3 Sampling of dialysate for microbiology analysis ..........................5-25
5.8.4 Setting the ultrafiltration parameters .............................................5-27
5.8.5 Setting the pressure limits..................................................................5-29
5.8.6 Setting the heparin parameters.........................................................5-31
5.9 Rinsing the dialyzer............................................................................5-33
5.9.1 Rinsing the dialyzer using standard A/V tubing............................5-33
5.9.2 Rinsing the dialyzer using Streamline® bloodline........................5-34
5.10 Stand-by mode...................................................................................5-35
5.10.1 Activating the stand-by mode ...........................................................5-35
5.10.2 Switching off the stand-by mode.....................................................5-35
5.11 Power failure in preparation.............................................................5-36
5.12 Changing the bicarbonate cartridge during preparation...............5-36
6 Initiating hemodialysis ........................................................................... 6-3
6.1 Checking the patient data................................................................... 6-3
6.2 Connecting the patient and starting hemodialysis...........................6-4
6.2.1 Level regulation in therapy (if present)..............................................6-5
6.3 During hemodialysis............................................................................. 6-7
6.3.1 Monitoring the blood-side pressure limits........................................6-7
6.3.2 Treatment at minimum UF rate............................................................6-9
6.3.3 Heparin bolus..........................................................................................6-10
6.3.4 Arterial bolus (saline)............................................................................6-10
6.3.5 Graphic representation of treatment parameters (trend)..........6-12
6.3.6 Interrupting hemodialysis (bypass)...................................................6-15
6.3.7 Completion of treatment.....................................................................6-15
6.3.8 Terminating treatment .........................................................................6-15
6.3.9 Continuing treatment...........................................................................6-15
7 Ending hemodialysis therapy.................................................................7-3
7.1 Reinfusion .............................................................................................7-3
7.2 Emptying the cartridge after dialyzer drain...................................... 7-5
7.3 Emptying the dialyzer.......................................................................... 7-5
7.3.1 Removing dialyzer and blood tubing system ....................................7-5
7.4 Overview of the therapy carried out Touch icon.............................. 7-6
8 Disinfection ............................................................................................. 8-3
8.1 Procedure and disinfectants................................................................ 8-3
8.2 Preparing for disinfection ................................................................... 8-5
8.2.1 Positioning the disinfectant container...............................................8-5
8.2.2 Selecting the disinfection program.....................................................8-5
8.3 Automatic switch-off and restarting................................................. 8-7
8.3.1 Automatic switch-off after disinfection............................................8-7
8.3.2 Automatic switch-off and restarting..................................................8-7
IFU 38910363US / Rev. 2.15.10 / May 2016 V
Table of contents Dialog+®
8.4 Chemical disinfection .......................................................................... 8-8
8.5 Short chemical disinfection ................................................................ 8-9
8.6 Thermal disinfection ..........................................................................8-10
8.7 Disinfection of incoming water from water supply........................8-11
8.7.1 Chemical disinfection with disinfecting solution
from central water supply...................................................................8-12
8.7.2 Automatic chemical disinfection with disinfectant
from central water supply...................................................................8-13
8.7.3 Thermal disinfection with hot permeate from
central water supply.............................................................................8-15
8.7.4 Rinsing the permeate inlet..................................................................8-16
8.8 Checking for disinfectant residues...................................................8-17
8.9 Decalcification....................................................................................8-18
8.9.1 Automatic descaling .............................................................................8-18
8.10 Terminating disinfection ...................................................................8-20
9 Single-needle procedure ........................................................................9-3
9.1 Single-needle valve (SN-valve) .......................................................... 9-3
9.1.1 Preparing the therapy..............................................................................9-3
9.1.2 Level regulation in SN-valve mode (if present)................................9-5
9.1.3 Running the therapy................................................................................9-7
9.1.4 Ending the therapy...................................................................................9-8
10 Use of accessories and 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 Starting/stopping measurement........................................................10-8
10.1.4 Showing and graphically displaying measured values................10-9
10.2 Bicarbonate cartridge holder..........................................................10-10
10.2.1 Inserting the cartridge........................................................................10-10
10.2.2 Changing the cartridge during dialysis..........................................10-11
10.2.3 Emptying the cartridge after treatment........................................10-14
10.3 Central concentrate supply.............................................................10-15
10.4 AdimeaTMOption UV – Kt/V............................................................10-16
10.4.1 Setting the parameters.......................................................................10-17
10.4.2 Graphic representation during therapy .........................................10-18
10.4.3 Target warning......................................................................................10-20
10.4.4 Extended functionality when using
the patient therapy card....................................................................10-21
10.4.5 Kt/V table ...............................................................................................10-23
10.5 Dialysis fluid filter............................................................................10-24
10.5.1 Use and mode of operation...............................................................10-24
10.5.2 Changing dialysis fluid filter.............................................................10-25
10.5.3 Resetting the data...............................................................................10-28
10.5.4 Disinfection............................................................................................10-29
10.6 Emergency power supply/battery ...................................................10-30
10.6.1 Charging indicator...............................................................................10-31
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Dialog+® Table of contents
10.6.2 Automatic battery test.......................................................................10-31
10.6.3 Ending battery operation...................................................................10-32
10.7 Communication interfaces ..............................................................10-32
10.7.1 Dialog+computer interface (DCI)....................................................10-32
10.8 Rinse bucket......................................................................................10-32
10.8.1 Care of the rinse bucket.....................................................................10-32
11 Configuration........................................................................................11-3
11.1 Automatic switch-off........................................................................11-3
11.2 Weekly disinfection program............................................................11-5
11.3 Configuring the 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 Selecting UF profiles...........................................................................11-11
11.5.2 UF profile table.....................................................................................11-13
11.6 Patient therapy chip 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 Theoretical Kt/V calculation ...........................................................11-21
11.8 Adjusting monitor brightness..........................................................11-26
11.9 Selecting language of screen text..................................................11-27
11.10 Editing trend group parameters .....................................................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 Displaying and resetting alarms........................................................13-3
13.2 Alarms and consequences..................................................................13-5
13.3 Remedying SAD alarms when using
standard A/V tubing systems ..........................................................13-39
13.4 Manual blood return........................................................................13-41
IFU 38910363US / Rev. 2.15.10 / May 2016 VII
Table of contents Dialog+®
13.5 Muting acoustic signals...................................................................13-43
13.5.1 Muting acoustic signals for alarms................................................13-43
13.5.2 Muting acoustic signals for messages...........................................13-43
14 Accessories and options....................................................................... 14-3
14.1 Accessories and options.....................................................................14-3
14.2 Additional accessories........................................................................14-4
14.3 Configurations....................................................................................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 ABPM blood pressure monitoring...................................................15-12
15.8 Technical data of Crit-Line® interface..........................................15-13
16 Appendix ............................................................................................... 16-3
16.1 Dialysate flow chart...........................................................................16-3
16.1.1 Key to dialysis flow chart....................................................................16-3
16.1.2 Flow chart Dialog+.................................................................................16-5
16.2 Service protocols................................................................................16-6
VIII IFU 38910363US / Rev. 2.15.10 / May 2016
Dialog+® Safe handling
Table of contents
1 Safe handling....................................................................................... 1-3
1.1 Intended use and indications .............................................................. 1-3
1.2 Contraindications ................................................................................. 1-3
1.3 Side effects...........................................................................................1-3
1.4 About these Instructions for Use........................................................ 1-4
1.4.1 Applicability................................................................................................1-4
1.4.2 Target group...............................................................................................1-4
1.4.3 Warnings, notices and symbols in these Instructions for Use.....1-4
1.4.4 Abbreviations.............................................................................................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 interaction..................................................................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 User requirements.....................................................................................1-8
1.6.3 Conformity..................................................................................................1-8
1.6.4 Manufacturer’s warranty........................................................................1-9
1.6.5 Technical changes.....................................................................................1-9
1
1.7 Disposal.................................................................................................. 1-9
IFU 38910363US / Rev. 2.15.10 / May 2016 1-1
1
Safe handling Dialog+®
1-2 IFU 38910363US / Rev. 2.15.10 / May 2016
Dialog+® Safe handling
1 Safe handling
1.1 Intended use and indications
This dialysis machine can be used for implementing and monitoring hemodialysis
treatments for patients with acute or chronic kidney failure. The system can be used in
hospital, health center and outpatient dialysis center settings when prescribed by a
physician.
The following types of renal replacement therapy can be carried out with the system:
• Hemodialysis (HD) with or without phases of pure ultrafiltration
high flux hemodialysis
low flux hemodialysis
1.2 Contraindications
There are no known contraindications for chronic hemodialysis.
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
1.3 Side effects
Hypotension, nausea, vomiting and cramps are possible side effects.
Hypersensitivity reactions caused by using the necessary tubing and filter materials
have been observed in only a few cases. For more information on this matter, please
refer to the product information provided with the disposables.
IFU 38910363US / Rev. 2.15.10 / May 2016 1-3
Safe handling Dialog+®
1
1.4 About these Instructions for Use
These Instructions for Use form an integral part of the dialysis machine. They describe
the appropriate and safe use of the dialysis machine at all stages of operation.
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 Instructions for Use to any future user of the dialysis machine.
1.4.1 Applicability
Art. no.
These Instructions for Use apply to Dialog+dialysis machines with the following article
numbers (art. no.):
• 710200K
• 710200L (with bicarbonate cartridge holder)
• 710220U (with Adimea, DF filter, WAN-BSL)
• 710200S (with bicarbonate cartridge holder, Adimea, DF filter, WAN-BSL)
Software version
These Instructions for Use apply to software version 9.1x (x = any)
1.4.2 Target group
The target group for these Instructions for Use is the dialysis medical staff.
The dialysis machine may only be used by persons instructed in its appropriate
operation. Furthermore, all clinical parameters have to be ordered and controlled by a
physician.
1.4.3 Warnings, notices and symbols in these Instructions for Use
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.
1-4 IFU 38910363US / Rev. 2.15.10 / May 2016
Dialog+® Safe handling
DANGER
WARNING
CAUTION
There are three levels of warning notices:
Warning term Meaning
Imminent danger that can lead to death or serious injury if not
avoided
Potentially imminent danger that can lead to death or serious
injury if not avoided
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
the preventive measures are not followed!
CAUTION
This is the list of measures to prevent the hazard.
1
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.
IFU 38910363US / Rev. 2.15.10 / May 2016 1-5
Safe handling Dialog+®
1
1.4.4 Abbreviations
ABPM Automatic blood pressure monitoring
BPA Arterial blood pump
BPV Venous blood pump
HD Hemodialysis
HP Heparin pump
PA Arterial pressure
PBE Blood-side entry pressure at dialysis machine
PBS Blood pump control pressure for single-needle procedure
PV Venous pressure
RDV Venousred detector
SAD Safety air detector
SAKA Arterial tube clamp
SAKV Venous tube clamp
SN Single-needle
TMP Trans membrane pressure
TSM Technical support and maintenance mode
UF Ultrafiltration
ZKV Central concentrate supply
WARNING
1.5 Special hazards and precautions
1.5.1 Special patient conditions
The patient’s physician must be notified of any special patient conditions, such as
unstable circulation or hypokalemia, prior to therapy.
Fluid Balance deviations can exceed a level that can be tolerated by low weight
patients, even if deviations are within the specified Dialog+accuracy value, and
in particular if the weight of the patients is equal or lower than 30 kg.
The treatment of these patients shall be performed under the full supervision
of the physician.
In these cases, the use of an additional device to measure the weight loss is
recommended.
The appropriate dialyzer and blood line must be selected according to the
patient’s size, weight and treatment type.
1-6 IFU 38910363US / Rev. 2.15.10 / May 2016
Dialog+® Safe handling
WARNING
1.5.2 Electrical hazards
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 and not on the mains cord to connect or
disconnect the mains plug.
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 power cord is
damaged in any way. A damaged dialysis machine must be submitted for repairs or
disposal.
Interaction with other devices
When using the dialysis machine in combination with other therapeutic devices, a
potential equalization device must be connected, since the leakage currents from all
connected devices are summarized 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 connect them in parallel.
1
CAUTION
Use with central-venous catheter
For patients with a central venous catheter, a higher degree of protection against
electric shock is required. As electric currents can run through supply lines, via the
dialyzer, the catheter, the patient and every conducting object in the vicinity of the
patient, electrical potential equalization must be provided. As soon as earth potential
equalization 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
potential equalization cable is available, which 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 also chapter 1.6.4).
1.5.3 Electromagnetic interaction
The dialysis machine has been developed and tested in accordance with the valid
standards for interference suppression and EMC. It cannot, however, 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
IEC 60601-1-2 (see also chapter 15.3).
IFU 38910363US / Rev. 2.15.10 / May 2016 1-7
Safe handling Dialog+®
1
CAUTION
If other therapeutic or diagnostic medical devices are placed on, near by, or
nonmedical devices are used near Dialog+, they may have an influence on
electromagnetic interactions. The user must observe the proper operation of Dialog
and all other machines when these combinations exist.
1.5.4 Maintenance and filter change
In order to protect patients against cross-contamination, the transducer protectors of
standard tubing systems are equipped with hydrophobic 0.2 m filters.
Risk to patient due to infection as a result of contamination of the transducer
protector on the tubing system!
Replace the machine-side transducer protector if it has been contaminated
with blood.
Instruct technical service to replace transducer protector, tubing and pressure
port.
Execute disinfection after replacement.
Only use the machine again when the filter has been changed.
1.6 Information for the operator
+
CAUTION
Rx only!
1.6.1 Training by manufacturer prior to commissioning
The operator may use this device only after the manufacturer has trained the
responsible staff based on these Instructions for Use.
1.6.2 User requirements
The dialysis machine may be used only by persons instructed in 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
conditioning of the dialysis machine.
1.6.3 Conformity
This dialysis machine complies with the requirements of the generally applicable
standards in their respective valid version:
• ANSI/AAMI/IEC 60601-1
• IEC 60601-2-16
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
1-8 IFU 38910363US / Rev. 2.15.10 / May 2016
Dialog+® Safe handling
configurations must conform with the valid version of the 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
system is compliant with a valid version of the System Standard IEC 60601-1-1. In
case of questions, 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.
USA
In the USA, the dialysis machine is a class II device complying with the fundamental
requirements of 21 CFR (Code of Federal Regulations) §876.5860.
1.6.4 Manufacturer’s warranty
The manufacturer, assembler, installer or implementer may 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 authorized by the manufacturer.
• the electrical installation of the affected room complies with the valid national
requirements on the equipment of medical treatment rooms (i. e. IEC stipulations).
The device may be operated only if the manufacturer or an authorized 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.
1
1.6.5 Technical changes
We reserve the right to change our products in line with further technical
developments.
1.7 Disposal
Dialysis machines may be returned to the manufacturer for disposal in accordance
with the applicable disposal guidelines.
The Dialysis machine has to be disinfected according to regulations before disposal.
IFU 38910363US / Rev. 2.15.10 / May 2016 1-9
1
Safe handling Dialog+®
1-10 IFU 38910363US / Rev. 2.15.10 / May 2016
Dialog+® Product description
Table of contents
2 Product description ............................................................................. 2-3
2.1 Components ..........................................................................................2-4
2.1.1 Extracorporeal system .............................................................................2-4
2.1.2 Dialyzer........................................................................................................2-4
2.1.3 User interface.............................................................................................2-4
2.1.4 Control system...........................................................................................2-5
2.1.5 Balance chamber and UF-control.........................................................2-5
2.1.6 Water preparation ....................................................................................2-5
2.1.7 Concentrate preparation.........................................................................2-5
2.2 Basic models.......................................................................................... 2-6
2.2.1 Dialog+single-pump machine...............................................................2-9
2.3 Symbols on the dialysis machine......................................................2-10
2.4 Control elements and information on the monitor........................2-11
2
2.5 Overview of all icons..........................................................................2-13
2.6 Entering numerical values.................................................................2-20
2.7 Using the timer/stop watch...............................................................2-23
IFU 38910363US / Rev. 2.15.10 / May 2016 2-1
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Product description Dialog+®
2-2 IFU 38910363US / Rev. 2.15.10 / May 2016
Dialog+® Product description
Model #710200L, single
-
pump
Bicarbonate cartridge holder
2 Product description
The Dialog+is a Hemodialysis Delivery System Machine available in four models
Model # 710200K: Dialog+single-pump
Model # 710200L: Dialog+single-pump, with bicarbonate cartridge holder
Model # 710200U: Dialog+single-pump, with Adimea, DF filter, WAN-BSL
Model # 710200S: Dialog+single-pump, with bicarbonate cartridge holder, Adimea,
DF filter, WAN-BSL
The Dialog+machine is suitable for hospital hemodialysis and also for dialysis centers.
It can use and store different profiles for many parameters such as: UF, sodium,
bicarbonate, heparin, dialysate flow, and temperature.
Treatment can be performed with bicarbonate or acetate concentrate supplied from a
canister or from central supply. A bicarbonate cartridge can be used as well.
configuration with bicarbonate
cartridge holder
2
Fig. 2-1 Dialog+system models
IFU 38910363US / Rev. 2.15.10 / May 2016 2-3
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“Disposables“
“Dialog
+
machine
“
Product description Dialog+®
2.1 Components
The Dialog+system consists of the following components:
Extracorporeal circulation system
Dialyzer
User interface
Control and safety monitoring systems, e.g. auto clamps, alarms, etc.
Balance chamber and UF control
Water preparation
Concentrate preparation
2.1.1 Extracorporeal system
The extracorporeal system consists of the machine’s peristaltic pumps, which are used
to transport the blood to the dialyzer and from the dialyzer back to the patient.
Blood is pumped through a disposable extracorporeal system mainly composed of
tubing, connectors, drip chambers and the dialyzer.
Peristaltic pumps withdraw blood from the patient’s vascular access into the dialyzer.
A syringe pump pumps heparin into the bloodlines in a quantity and time set by the
user to avoid the coagulation of the blood in the disposable circuit and the dialyzer
filter.
2.1.2 Dialyzer
The capillary dialyzer houses semipermeable hollow fibers encased in a plastic canister.
The dialyzer is used to correct the concentration of water-soluble substances in the
patients blood before delivering it back to the patient. The blood is separated from the
dialyzing fluid by a semi-permeable membrane that permits bidirectional diffusive
transport and ultrafiltration. The process also allows diffusion of substances from the
dialyzing fluid into the blood.
2.1.3 User interface
The user interface is a display panel that provides communication between the
machine and the user. On the display it is possible to visualize all the dialysis
parameters and relevant information about the procedure and alarm conditions.
By touching the icons on the screen, the user can input all the parameters for the
treatment such as: dialysis time, UF volume and heparin pump flow. Several profiles
for the procedure can be selected and set via the interface.
The five buttons at the bottom of the screen (see Fig. 2-6) have fixed functions i.e.,
control the arterial pump, to enter and confirm the entry input and to reset the alarms.
2-4 IFU 38910363US / Rev. 2.15.10 / May 2016
Dialog+® Product description
2.1.4 Control system
The control system is divided into two parts:
The top level control system connects the interface with the user and transmits data
to and from other modules. The low level control system controls and monitors the
machine and its functions and also communicates with the top level control system.
Both systems operate independently of each other.
2.1.5 Balance chamber and UF-control
The balance chamber system is a closed system and consists of two chambers, each
with a flexible membrane, allowing it to fill the chambers from one side while an
identical volume is emptied to the other side. Therefore the outlet fluid volume is
equal to the input fluid volume.
Each membrane has a magnetic sensor which reads the membrane position and
controls the opening and the closing of each sub compartment.
The control of the dialysate volume is also carried out by the balance chamber. The
difference between used dialysate and fresh dialysate is the ultrafiltration volume,
which is removed from the blood side of the dialyzer. Ultrafiltrate removal is carried
out by the UF pump.
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2.1.6 Water preparation
Purified water coming from the reverse osmosis system has to be degassed and
tempered to a predetermined temperature, which is set by the user (usually
37°C/99 °F), before the concentrate is prepared. A degassing chamber and a heater are
integral to the system.
2.1.7 Concentrate preparation
In bicarbonate dialysis, which is the most common procedure, concentrate preparation
consists of mixing the heated and degassed water with bicarbonate concentrate and
acid concentrate. The accuracy of dialysate concentration is controlled by conductivity
sensors. If the concentration is incorrect, the dialyzer will be bypassed.
IFU 38910363US / Rev. 2.15.10 / May 2016 2-5
Product description Dialog+®
Venous pressure sensor
Venous tube clamp
2.2 Basic models
2
Legend
1
connection (blue)
Arterial pressure sensor
2
connection (red)
Heparin pump
3
Syringe stop
4
Blood pump (one or two blood
5
pumps depending on basic
model)
Rinsing chambers for
6
concentrate rods
7
Safety air detector (SAD) and red
8
sensor
Fixture for the chamber of the
9
blood tubing system
Fixture for blood tubing system
10
The basic model Dialog+single-pump machine is shown in the figure below. The
legend highlights the components installed in all basic models.
Front view
2-6 IFU 38910363US / Rev. 2.15.10 / May 2016
Fig. 2-2 Basic model single-pump, front view
Dialog+® Product description
Legend
Infusion pole (in
1
some models, pole
may not be
adjustable)
Multi Functional
2
Tray
Bicarbonate
3
cartridge holder
(optional)
Connection for
4
central
concentrate supply
(optional)
Connection for
5
disinfectant
Connections for
6
dialyzer tubing and
rinsing bridge
Card reader
7
Wheel lock
8
2
Fig. 2-3 Basic model, side views
IFU 38910363US / Rev. 2.15.10 / May 2016 2-7
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Product description Dialog+®
Legend
Mains switch
1
WAN-BSL
2
Crank for manual blood return
3
Fixture for disinfectant
4
container
Ground connection
5
Power cord
6
Water inlet
7
Dialysate outlet
8
Water inlet
7
Dialysate outlet
8
Fig. 2-4 Basic model, rear view
2-8 IFU 38910363US / Rev. 2.15.10 / May 2016
Dialog+® Product description
2.2.1 Dialog+single-pump machine
The Dialog+single-pump dialysis machine is suitable for hospitals, health centers and
outpatient dialysis centers. It offers the following features as standard:
• Color screen and on-screen operation (color touch screen)
• Acetate/bicarbonate operation
• Volumetric ultrafiltration
• Heparin syringe pump
• Heat exchanger
• Fixed or freely selectable profile controls for dialysate composition, temperature
and flow rate, for heparin supply and for ultrafiltration
The following features are available as additional accessories/options:
• Automatic blood pressure monitoring (ABPM)
• Bicarbonate cartridge holder
• Level regulation
• Central concentrate supply (ZKV)
• Dialysis fluid filter
• Dialysis fluid filter holder
• Emergency power supply
• Data interface
– Dialog+computer interface (DCI)
– WAN BSL (Bed Side Link): Card reader and interface to data management system
– Card reader
• AdimeaTMOption UV–Kt/V
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Therapy types
The Dialog+dialysis machine with a single blood pump can be used for the following
therapy procedures:
• Hemodialysis (HD) with or without phases of pure ultrafiltration
• High-flux hemodialysis
• Low-flux hemodialysis
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 procedure
IFU 38910363US / Rev. 2.15.10 / May 2016 2-9
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Product description Dialog+®
2.3 Symbols on the dialysis machine
Observe Instructions for Use
Observe Safety information
Type B applied part
Classification acc. to IEC 60601-1
Type BF applied part
Classification acc. to IEC 60601-1
Electrical ground
Dialysis machine OFF
Dialysis machine ON
Alternating current
Schematic illustration on safety air detector (SAD), showing the correct way of
installing the tube
Connection for optional automatic blood pressure monitoring (ABPM)
2-10 IFU 38910363US / Rev. 2.15.10 / May 2016
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