B.Braun Dialog+ User manual

Dialog+® Dialysis Machine

Instructions for Use SW 9.1x

CE marking according to directive 93/42/EEC
Technical alterations reserved	Manufacturer:
	B. Braun Avitum AG
Rx only	34209 Melsungen, Germany
	Tel [phone]
	Fax [phone]
RTD.IM01 04/05	US Distributor:
	B. Braun Medical Inc.
	Avitum Division
	Bethlehem, PA 18018-3524, USA
	Made in Germany
	Tel [phone]
IFU 38910363US / Rev. 2.15.10 / May 2016	Fax [phone]

Dialog+®	Table of contents

1Safe handling

2Product description

3Installation and commissioning

4Therapy types

5Preparing for hemodialysis

6Initiating hemodialysis

7Ending hemodialysis therapy

8Disinfection

9Single-needle procedure

10Use of options

11Configuration

12Maintenance and cleaning

13Alarms and remedial action

14Accessories

15Technical data

16Appendix

1

2

3

4

5

6

7

8

9

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

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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	5-21
		5.8.2	5-24
		5.8.3	5-25
		5.8.4	5-27
		5.8.5	5-29
		5.8.6	5-31
	5.9	Rinsing the dialyzer............................................................................	5-33
		5.9.1	5-33
		5.9.2	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	6-10
		6.3.4	6-10
		6.3.5 Graphic representation of treatment parameters (trend) ..........	6-12
		6.3.6	6-15
		6.3.7	6-15
		6.3.8	6-15
		6.3.9	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

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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 AdimeaTM Option 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

VI	IFU 38910363US / Rev. 2.15.10 / May 2016

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

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

IFU 38910363US / Rev. 2.15.10 / May 2016

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Safe handling	Dialog+®

1

1-2	IFU 38910363US / Rev. 2.15.10 / May 2016

Dialog+®	Safe handling

1 Safe handling

1

1.1Intended 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

1.2Contraindications

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.

1.3Side 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

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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

There are three levels of warning notices:

					1
	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
	the preventive 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.

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	Venous red 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
	1.5	Special hazards and precautions

1.5.1Special 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.
WARNING	 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

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 and 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 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.

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).

1.5.3Electromagnetic 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

CAUTION

IEC 60601-1-2 (see also chapter 15.3).

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Safe handling	Dialog+®

	1
				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.

CAUTION

 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.

1.6Information for the operator

CAUTION

Rx only!

1.6.1Training 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.

1.6.2User 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.

1.6.3Conformity

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

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	Dialog+®				Safe handling
	configurations	must	conform with the valid	version of	the	System	Standard
	IEC 60601-1-1.									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.

1.6.4Manufacturer’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.

1.6.5Technical changes

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

1.7Disposal

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.

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Safe handling	Dialog+®

1

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Dialog+®	Product description

Table of contents

2

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

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2-1

Product description	Dialog+®

2

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Dialog+®	Product description

2 Product description

The Dialog+ is a Hemodialysis Delivery System Machine available in four modelsModel # 710200K: Dialog+ single-pump

Model # 710200L: Dialog+ single-pump, with bicarbonate cartridge holder 2Model # 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.

Model #710200L, single-pump				Bicarbonate cartridge holder
configuration with bicarbonate
cartridge holder

Fig. 2-1

Dialog+ system models

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Product description	Dialog+®

2

“Disposables“

“Dialog+ machine“

2.1Components

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

2.1.1Extracorporeal 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.

2.1.2Dialyzer

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.

2.1.3User 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.

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Dialog+®	Product description

2.1.4Control system

The control system is divided into two parts:

The top level control system connects the interface with the user and transmits data 2 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.

2.1.5Balance 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.

2.1.6Water 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.

2.1.7Concentrate 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.

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Product description	Dialog+®

				2.2		Basic models
	2
					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
			Legend
1				Venous pressure sensor
				connection (blue)
2				Arterial pressure sensor
				connection (red)
3				Heparin pump
4				Syringe stop
5				Blood pump (one or two blood
				pumps depending on basic
				model)
6				Rinsing chambers for
				concentrate rods
7				Venous tube clamp
8				Safety air detector (SAD) and red
				sensor
9				Fixture for the chamber of the
				blood tubing system
10				Fixture for blood tubing system

Fig. 2-2

Basic model single-pump, front view

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Dialog+®	Product description

Legend

1 Infusion pole (in

some models, pole 2 may not be

adjustable)

2Multi Functional Tray

3Bicarbonate cartridge holder (optional)

4Connection for central concentrate supply (optional)

5Connection for disinfectant

6Connections for dialyzer tubing and rinsing bridge

7Card reader

8Wheel lock

Fig. 2-3 Basic model, side views

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1

2 2

3

4

Product description	Dialog+®

Legend

Mains switch

WAN-BSL

Crank for manual blood return

Fixture for disinfectant container

5Ground connection

6Power cord

7Water inlet

8Dialysate outlet

7Water inlet

8Dialysate outlet

Fig. 2-4 Basic model, rear view

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Dialog+®	Product description

2.2.1Dialog+ 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:			2
•	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

•AdimeaTM Option UV–Kt/V

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

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Product description	Dialog+®

2.3Symbols on the dialysis machine

2

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)

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