CeCon 3000 Operating Manual sw ver 091023 Nov 2015

Table of Contents: 1

Explanation of the symbols used in this manual ...5

2

Preliminary remarks ...5

3 General information ...6 3.1 Applicable directives, laws, standards ...6 3.2 Intended and proper use ...6 3.3 Duties of the operator...6 3.4 Qualification of the operating personnel ...7 3.5 Packaging and transport ...7 3.6 Scope of delivery...7 3.7 Spare parts ...8 3.8 Disposal ...8 3.9 Supplementary documentation ...8 3.10 Extras ...8 4 4.1 4.2 4.3 4.4 4.5

Safety information ...9 Hazards – overall estimation ...9 General safety information ...9 Electrical hazards ...9 Emissions ...9 Electromagnetic compatibility ...9

5 Labelling ...10 5.1 Name plate ...10 5.1.1 Symbols on the name plate and their meaning ...11 5.2 Concentrate ports ...12 5.2.1 Identification of connections and sorts ...13 5.2.2 Overview of assignments ...13 6

Concentrate connection block ...14

7 Specifications ...15 7.1 Technical data ...15 7.2 Flow diagrams ...16 7.2.1 1 level - 1 sort (03CE00111) ...16 7.2.2 1 level - 2 sorts (03CE00112) ...16 7.2.3 1 level - 3 sorts (03CE00113) ...17 7.2.4 2 levels - 1 sort (03CE00121) ...17 7.2.5 2 levels - 2 sorts (03CE00122) ...18 7.2.6 3 levels - 1 sort (03CE00131) ...18 7.3 Sequence of operations ...19 8

Installation ...19

9

Start-up ...19

10 Operation ...20 10.1 Control panel and key assignments ...20 10.2 Operating modes ...21 10.3 Start screen ...21 10.4 Switching ON / OFF ...21 10.5 Displaying operating parameters ...22 10.5.1 Dialogue: Operation values ...23 10.5.2 Dialogue: Pump capacity ...24 10.5.3 Dialogue: System control ...25 10.5.4 Dialogue: Running hours...26 10.5.5 Dialogue: Set points P...27 CABA1E-8 Operating manual CeCon 3000.doc

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10.5.6 10.5.7 10.5.8

Dialogue: Control factors...28 Dialogue: System info ...29 Dialogue: Pump passivation ...30

11 User functions ...31 11.1 Change of container ...31 11.2 View the message list ...31 12 Maintenance and service ...32 12.1 Inspection intervals ...32 12.2 External cleaning ...32 12.3 Disinfection ...32 13 Alarms and messages ...33 13.1 Display of faults ...33 13.2 Overview of messages and alarms ...34

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1

Explanation of the symbols used in this manual Indicates a dangerous situation. Ignoring this may result in bodily harm, including severe injuries. (Note: when applied to medical devices, this sign may mean “read the accompanying documentation”.)

Indicates a potentially dangerous situation. Ignoring this may result in material damage.

Indicates useful information relating to the particular topic and important instructions that must be followed.

2

Preliminary remarks

The concentrate supply unit CeCon 3000 is a well-engineered and reliable product built according to the state-of-the-art principles and safety engineering codes. This operating manual provides all users with instructions for the safe and reliable operation of the unit. It is an important document and an aid for operation and servicing. It also describes troubleshooting procedures. Please read this operating manual, follow the instructions and ensure that the operating manual is always readily accessible near the system.

Read the operating manual before you use or work on the unit.

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3

General information

3.1

Applicable directives, laws, standards



Council Directive 93/42/EEC from 14 June 1993 concerning medical devices



EN 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance



EN 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests

3.2

Intended and proper use

The CeCon 3000 is intended exclusively as a concentrate supply unit for approved dialysis stations and may only be operated by appropriately trained personnel. The unit is intended as a supply unit to feed acidic dialysis concentrate into a piping system and can distribute up to three different sorts of concentrate each with a different delivery pressure. The data given in the specifications with respect to pressure, line length and ambient conditions apply. Intended and proper use also includes observance of the stipulated operating and maintenance instructions. Changes to the performance of the unit as well as the use of spare parts other than those supplied by DWA must be reviewed and approved by DWA. Any change in use or modification is regarded as a violation of the intended and proper use. This also applies to operation of the unit with defective safety devices as well as improper installation, start-up, operation and repair of the system. DWA GmbH & Co. KG is not liable for any damages arising as a consequence of such violations.

3.3

Duties of the operator

In accordance with the German Ordinance on Industrial Safety and Health and the German Ordinance on the Installation, Operation and Use of Medical Devices the owner/operator is responsible for 

observance of the safety requirements and precautions relating to occupational safety and accident prevention,



correct operation of the unit by trained personnel in accordance with the intended use,



competent training of the personnel operating the unit and for their knowledge of the operating instructions,



filling out a medical device inventory



and carrying out of the safety checks on schedule by trained technicians (service personnel).

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3.4

Qualification of the operating personnel

The operating personnel, generally nursing staff, must be instructed in the operation and special features of the unit. Only adult personnel trained in the use of the system are permitted to operate the unit! This training must be carried out by the manufacturer or trained technicians (service personnel) during start-up of the unit and as needed. No further training is required to operate the unit.

Service personnel are trained exclusively by DWA and upon successful completion of training, participants receive a certificate authorising them to perform commissioning, maintenance, repairs and electrical safety checks.

3.5

Packaging and transport Observe the accident prevention regulations and handling instructions on the packaging! Do not throw; do not place heavy objects on top! Packaging: 810 x 460 x 670 (L x W x H) mm, weight: 37 kg

Protect from frost and heat. Store and transport between +1 °C and +45 °C

If condensation has collected during transport between two locations with different temperatures and a high humidity, the inside of the unit must dry out before the unit can be switched on.

3.6

Scope of delivery

The scope of delivery of the concentrate supply unit CeCon 3000 comprises 

a complete unit according to the order details

as well as the following parts: No. Quantity

Unit

Part No.

1

1

piece

SO8BCEC1E

Operating manual CeCon 3000

2

1

piece

SO8D02067

Coated mounting bracket CeCon 3000

3

1

piece

ZG12AL025

Protective bracket CeCon 3000

4

1

piece

SO8C63005

Mounting materials for the mounting bracket and protective bracket

5

1

piece

ESO8B020902

Labelling for concentrate lines

6

a)

piece

SO8C63008

Connection materials, container => CeCon

7

b)

piece

SO8C63007

Connection materials, container => connection block

8

c)

piece

SO8B63001

Concentrate connection block with connections

9

d)

piece

SO8C63002

Mounting materials for connection block CeCon 3000

10

e)

piece

ZG13AUFK7x

Labelling of connection block: level – sort

CABA1E-8 Operating manual CeCon 3000.doc

Designation

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Note:

Items 6-10 depend on the configuration level of the concentrate supply unit: 03CE00111: 03CE00112: 03CE00113: 03CE00121: 03CE00122: 03CE00131:

3.7

a) 1

b) 1

c) 1

d) 1

e) ZG13AUFK74

a) 2

b) 2

c) 2

d) 2

e) ZG13AUFK74, ..75

a) 3

b) 3

c) 3

d) 3

e) ZG13AUFK74, ..75, ..76

a) 1

b) 2

c) 2

d) 2

e) ZG13AUFK74, ..77

a) 2

b) 4

c) 4

d) 4

e) ZG13AUFK74, ..75, ..77, ..78

a) 1

b) 3

c) 3

d) 3

e) ZG13AUFK74, ..77, ..79

Spare parts

The spare parts list is available for the service personnel in the Service manual CeCon 3000.

3.8

Disposal Implementation of Directive 2002/96/EC (WEEE Directive) of the European Community concerning waste electrical and electronic equipment means that it is no longer permissible to dispose of waste electrical equipment as well as electronic and electrical assemblies with domestic waste. These parts must be disposed of in an environmentally sound manner. Unless agreed otherwise with DWA or if a private waste management system is not available, DWA equipment or any of their components that may be environmentally hazardous can be returned to DWA.

3.9

Supplementary documentation

Detailed information on installation, start-up, maintenance and repair is available for service personnel for the concentrate supply unit CeCon 3000 in the Service manual CeCon 3000.

3.10

Extras

The CeCon 3000 can be optionally operated with a DWA remote control unit and is fitted with zero potential status outputs to send messages to a control centre.

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4

Safety information

4.1

Hazards – overall estimation

The unit has been designed and built according to state-of-the-art principles and conforms with the requirements of the EU Directive and the standards for medical devices.

If the unit is used in accordance with the intended purpose, it does not represent a hazard.

Malfunctions that affect the intended and proper use must be rectified immediately.

4.2

General safety information



Never bridge or bypass the safety devices.



Do not cover the unit or parts of the unit.



In case of unusual noises or odours and leakages: monitor the unit, disconnect the unit from the power supply and contact the service personnel!



Damaged lines or connections (concentrate, power supply) must be reported immediately to the service personnel.

4.3

Electrical hazards The electrical safety of the unit must be checked at least once a year during a general safety check.

4.4

Emissions

The unit does not produce any dust or vibrations. The measured noise level is well below 65 dB (A). Personal protection measures are thus unnecessary.

4.5

Electromagnetic compatibility

Medical electrical equipment is subject to special precautionary measures in respect of electromagnetic compatibility (EMC) and must be installed and put into operation according to the instructions in the accompanying documentation. EMC information according to EN 60601-1-2, Section 5.2.2 is given separately in the Service manual CeCon 3000.

The concentrate supply unit CeCon 3000 has been tested and is protected according to the requirements and recommendations of EN 60601-1-2 (Electromagnetic compatibility - Requirements and tests). Nevertheless, disturbances caused by electromagnetic radiation or other equipment cannot be ruled out. Portable and mobile RF communication equipment may affect medical electrical equipment. CABA1E-8 Operating manual CeCon 3000.doc

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5

Labelling The name plate, model designation and names of the concentrate connections are given on the left-hand side of the unit.

5.1

Name plate

The code REF represents the item number of the device.

The serial number SN consists of the year of manufacture, device identification and consecutive number: Example: xx CECON #### xx: Year of manufacture 20xx CECON: Device identification ####: consecutive number

The version label states the permissible mains voltage, mains frequency and the rated current consumption of the device: 230 V / 50-60 Hz / 1 A

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5.1.1

Symbols on the name plate and their meaning Symbol for "reference/item number".

Symbol for "serial number".

Symbol for "conformity with the Directive 93/42/EEC" concerning medical products. The following number identifies the notified body, in this case: 0044. IPX2

Statement of the protection type, in this case: Protection against dripping water.

Symbol for "follow the operating instructions".

Symbol for "separate collection of electrical and electronic devices" and "bringing into circulation after 13th August 2005".

Symbol for "manufacturer" in combination with the name and address of the manufacturer.

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5.2

Concentrate ports The identifiers of the concentrate ports are given underneath the name plate depending on the unit's configuration.

CeCon 3000 Konzentratversorgungsanlage

Concentrate supply system Système de distribution de concentré

Seriennummer Serial no. / No. de série

230 V / 50-60 Hz / 1 A / IP X2 0366

DWA GmbH & Co. KG Ubstadter Str. 28 76698 Ubstadt-Weiher Germany Katalog Nr. / Cat. No.:

Etage / level / étage

1

Sorte / sort / sorte

1

Port not installed

Port installed (CPC coupling)

Each installed concentrate port requires a separate connection block on the wall next to the CeCon 3000. Care must be taken that the labelled "level" and "sort" are correctly assigned to the appropriate connection block and/or the concentrate line. "Level" indicates the pressure level of the respective sort / line for concentrate distribution by the CeCon 3000.

Example:

A CeCon 3000 model 03CE00131 (3 levels - 1 sort) can deliver one sort of concentrate with three different target pressures at three different pressure levels because of the three pumps.

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5.2.1

Identification of connections and sorts In order to avoid a mix-up of connections, these must be clearly marked. The marking is applied by service personnel in agreement with the operator.

Pluged connections always have to show the same identification labels, e.g. L1 - L1, L2 - L2 etc.

5.2.2

Overview of assignments 03CE00111

03CE00112

03CE00113

03CE00121

03CE00122

03CE00131

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6

Concentrate connection block The concentrate connection block is the interface between the CeCon 3000 and the concentrate ring line. Each concentrate port installed on the CeCon 3000 has its own separate connection block on the wall to the left of the unit.

concentrate ring line Labelling (acc. to the unit assignments)

Etage level etagé Sorte sort sorte Etage level etagé Sorte sort sorte Etage level etagé Sorte sort sorte Etage level etagé Sorte sort sorte Etage level etagé Sorte sort sorte Etage level etagé Sorte sort sorte

1

1 1

2 1

3 2

1 2

2

connection to CeCon 3000

3

1 drain hose (for servicing work only!)

There is a special mode available to the service personnel for draining.

Note:

depending on the type of unit, the concentrate feed hose from the CeCon 3000 may be equipped with an angled connector. In this case, to prevent kinking of the hose, attach the angled feed connector from the CeCon 3000 to the coupling on the front of the block and the drain hose to the coupling at the bottom of the connection block.

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7

Specifications

7.1

Technical data

Dimensions and weight Dimensions (W x H x D) Weight (full system expansion) Performance data Supply rate Max. head Max. length of concentrate ring line Max. supply pressure (point of use) Electrical data Mains plug Mains voltage Mains frequency Power consumption Type of protection against electric shocks Level of protection against electric shocks Level of protection against penetration of liquids Circuit breaker (provided by customer) Ambient conditions, installation requirements Ambient temperature Concentrate supply Min. feed pressure Max. feed pressure

CABA1E-8 Operating manual CeCon 3000.doc

480 x 520 x 200 mm 25 kg 40 l/h per concentrate sort 20 m 500 m 2.5 bar Earthed safety plug 230 V 50 - 60 Hz 250 W Protection class I Applied part, type B IP X2 C 10 A 10 to 35 °C Hose DN8 0.01 bar 0.3 bar

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7.2 7.2.1

Flow diagrams 1 level - 1 sort (03CE00111) CeCon 3000

Cx Ex VBx MV x Px Dx

7.2.2

concentrate deaeration pump feed tank solenoid valve pump pressure sensor

1 level - 2 sorts (03CE00112)

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7.2.3

1 level - 3 sorts (03CE00113)

7.2.4

2 levels - 1 sort (03CE00121) CeCon 3000

Cx Ex VBx MV x Px Dx

concentrate deaeration pump feed tank solenoid valve pump pressure sensor

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7.2.5

2 levels - 2 sorts (03CE00122)

7.2.6

3 levels - 1 sort (03CE00131) CeCon 3000

Cx Ex VBx MV x Px Dx

concentrate deaeration pump feed tank solenoid valve pump pressure sensor

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7.3

Sequence of operations

Concentrate C flows from the connected container into the feed tank VB of the CeCon 3000. Each feed tank has two defined switching points via reed contacts. When the level drops below the upper switching contact, the deaeration pump E is switched on and the system is automatically evacuated. As soon as the lower contact is reached, the suction pump is switched off and the unit switches over to the full reserve container via the solenoid valves MV. The pump P transports the concentrate from the feed tank via a non-return value and a pressure sensor D into the concentrate connection block. The connection block is the interface to the concentrate ring line, which supplies the dialysis units at the patient stations. To prevent continuous operation and thus unnecessary wear of the concentrate supply pumps during dialysis pauses, the CeCon 3000 can switch off the pumps if it detects a static state, i.e. zero withdrawal from the line, over a freely definable time. The pumps restart automatically as soon as concentrate is withdrawn from the line.

8

Installation The unit is installed by DWA technicians or by the service personnel. The installation instructions are given in the Service manual CeCon 3000.

9

Start-up

Before starting dialysis operations, the operating parameters have to be set, the concentrate lines rinsed and vented and all connectors checked for leakages.

The unit is commissioned by DWA technicians or by the service personnel. The commissioning instructions are given in the Service manual CeCon 3000.

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10 Operation 10.1

Control panel and key assignments

0/I

RESET

TEST

INFO

LC display

CeCon 3000

The unit is operated using four keys

0/I

Start concentrate supply / STANDBY

RESET

Quits alarm / message and confirms switchover to another container

TEST

Selects dialogues for operating parameters

INFO

Opens and scrolls through the alarm list

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10.2

Operating modes The operator generally uses the unit in the following operating modes 

STANDBY and



ACTIVE (concentrate supply).

If a fault occurs or if maintenance work or entering settings are to be carried out, there are additional operating modes for the service personnel. Further details are given in the Service manual CeCon 3000.

10.3

Start screen

As soon as the CeCon 3000 is connected to the mains voltage, the following message is shown in the display field of the start screen: CONCENTRATE SUPPLY SYSTEM S T A N D B Y SELECT WITH “TEST“

10.4

Switching ON / OFF CONCENTRATE SUPPLY SYSTEM S T A N D B Y SELECT WITH “TEST“

Press the

0/I

key to start the concentrate supply

CONCENTRATE SUPPLY SYSTEM -- SYSTEM ACTIVE -SELECT WITH “TEST“

Press the

0/I

key to stop the concentrate supply

CONCENTRATE SUPPLY SYSTEM S T A N D B Y SELECT WITH “TEST“

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