CeCon 3000 Operating Instructions CABA1E-4

DWA GmbH & Co. KG

Operating Instructions CeCon 3000

Contents 1

Importance of the operating instructions ...4 1.1

Correct use ...5

1.1.1

2

3

4

5

Concentrate supply system CeCon 3000 ...5

1.2

Correct use ...5

1.3

Warranty and liability ...6

1.4

Copyright ...6

1.5

Manufacturer’s address...6

Basic safety instructions ...7 2.1

Observe the information in the operating instructions ...7

2.2

Obligations of the operator ...7

2.3

Obligations of the staff ...7

2.4

Hazards when using the system ...8

2.5

Explanation of the symbols ...8

2.6

General information and recommendations ...9

2.6.1

Maintenance ...9

2.6.2

Operation ...9

2.7

Hazards from electrical energy ...9

2.8

Maintenance, servicing, remedying faults ...9

2.9

Structural modifications to the system ...9

2.10

Cleaning the system ...9

Transport ...10 3.1

Dimensions and weight ...10

3.2

Ambient conditions ...10

System data ...10 4.1

Designation, type ...10

4.2

Advantages of the system ...10

4.3

Technical Data ...11

Setting up and putting into operation for the first time ...12 5.1

Installation location, place of use ...12

5.2

Setting up the system ...12

5.2.1 5.3

Putting into operation ...12

Energy and supply connection data ...13

5.3.1

Mains connection ...13

5.3.2

Remote Control ...13

5.3.3

Concentrate container connection ...13

5.3.4

Waste water connection ...13

5.4

Building-side preparations ...13

5.5

Installation plan ...14

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DWA GmbH & Co. KG 5.6

6

7

Acetate / bicarbonate version ...15

5.6.2

Switching contacts ...15

5.7

Container change ...15

5.8

Safety switching ...15

Operation ...16 6.1

Dialysis operation ...16

6.2

End of dialysis ...17

6.3

List of Alarms ...17

Operating Parameters ...18 Selection with TEST ...18

Service instructions ...22 8.1

Setting the limit values ...23

8.1.1

Setting with the limit values key ...23

8.1.2

Setting Limit Values, Actual Time and Timers ...23

8.1.3

Limit values ...24

8.2

Service- Mask ...25

8.3

Adjustment ...26

8.3.1

Adjusting the pressure ...26

8.3.2

LCD display contrast ...26

8.3.3

Pressure range ...26

8.4 9

Method ...15

5.6.1

7.1 8

Operating Instructions CeCon 3000

Disinfection instructions ...27

Drawings ...28 9.1

Flow diagram: System for 1 concentrate and 1 level ...28

9.2

Flow diagram: System for 1 concentrate and 2 levels ...29

9.3

Flow diagram: System for 2 concentrates and 1 level ...30

9.4

Flow diagram: System for 2 concentrates and 2 levels ...31

9.5

Flow diagram: System for 3 concentrates and 1 levels ...32

9.6

Flow diagram: System for 1 concentrate and 3 levels ...33

Appendix ...34 Appendix 1 ...34 Control Board...35 System configuration ...36 Maintenance ...37 Maintenance...37 Technical Safety Inspections (TSI) ...37 Protocols ...37 DWA Maintenance Protocol CeCon 3000...38 DWA – Handover Protocol CeCon 3000...39 Disinfection protocol ...40

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

1 Importance of the operating instructions

Dear Customer, Before putting the system into operation, please read this manual carefully and familiarise yourself with its functions and operating elements. This is absolutely essential in order to guarantee that the system is used correctly.

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

1.1 Correct use 1.1.1 Concentrate supply system CeCon 3000 The CeCon 3000 is used as the central concentrate supply unit in dialysis centres (optionally bicarbonate or acetate acid). This involves pumping the concentrate out of containers and into a supply line via the CeCon 3000. The CeCon 3000 ‘s task is to supply up to three types of concentrate from a maximum of six containers. If two containers are connected per type, the CeCon 3000 automatically switches over from the empty container to the full container. Possible unit combinations: Requirements:  Ring line system according to ISO 11197: PE/PA piping or hoses PE-Xa pipeline Hard or soft PVC  Dialysis unit: Connect only to dialysis units which can be operated with a concentrate pressure of 0.3 to 0.5 bar. Optional units:  Central line system, can be controlled via potential-free status outputs  Remote control

Perfect functioning of the CeCon 3000 with the listed units is guaranteed by DWA. Compatibility must be checked in each case if other system combinations are used. Performance changes and modifications to components supplied by other manufacturers and with other dimensions require an inspection and approval by the manufacturer. The CeCon 3000 may only be used for its intended purpose. Any other use shall be regarded as incorrect. The company DWA GmbH & Co. KG shall not be liable for any damage resulting from such incorrect use. Such risks shall be borne by the operator alone. Correct use also includes observing the operating and maintenance instructions stipulated by DWA GmbH & Co. KG as well as the servicing conditions.

The CeCon 3000 may only be used, maintained and serviced by persons who have the appropriate specialist knowledge and who have been informed about the hazards

1.2 Correct use The system is designed and constructed in accordance with the current state of the art and the recognised safety regulations. However, problems with the system or individual units or other assets can arise during use. The system may only be used  for its intended purpose  when it is in a completely safe condition, see Appendix 1. Faults must be remedied immediately.

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

1.3 Warranty and liability Our ”General Sales and Delivery Conditions” always apply. These are made available to the operator no later than when the contract is concluded. There shall be no possibility of warranty and liability claims for injuries and material damage if such damage is attributable to one or more of the following causes:

– –

Incorrect use of the system

–

Operation of the system with defective safety fixtures or incorrectly fitted or non-functional safety fixtures

– – – – – –

Incorrect assembly, putting into operation, operation and maintenance of the system

Non-observance of the operating instructions with regard to transport, storage, assembly, putting into operation, operation, maintenance and tooling of the system

Unauthorised structural modifications to the system Unauthorised modifications to the output Insufficient monitoring of system components which are subject to wear Incorrectly carried out repairs The influence of foreign bodies and force majeure.

The relevant accident prevention regulations of the professional liability insurers‘ associations and of the legislator, as well as the generally recognised safety regulations, must be observed. Unauthorised modifications to the CeCon 3000 shall exclude the possibility of liability on the part of DWA GmbH & Co. KG for any resulting damage. Any modifications to the CeCon 3000 must be referred to the manufacturer before being carried out.

1.4 Copyright The copyright on these operating instructions is held by the company DWA GmbH & Co. KG. These operating instructions are intended only for the operator and his staff. They contain regulations and information which may not be

 copied  distributed or  otherwise passed on to third parties, either in whole or in part. Contraventions can result in legal action. This manual was compiled with the necessary care. DWA GmbH assumes no liability for errors or omissions or for any resulting damages. We also reserve the right to change this document and the technical data of the product described in it without prior notification.

1.5 Manufacturer’s address DWA GmbH & Co. KG Ubstadter Straße 28 D- 76698 Ubstadt- Weiher

Tel.: +49 (0) 7251 690020 Fax.: +49 (0) 7251 690060

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

2 Basic safety instructions 2.1 Observe the information in the operating instructions  A basic requirement for safe handling and fault-free operation of this system is knowledge of the basic safety instructions and safety regulations  These operating instructions contain the most important information for operating the system safely  These operating instructions, particularly the safety instructions, must be observed by all persons working on the system  The accident prevention regulations applicable to the place of use must also be observed.

2.2 Obligations of the operator The operator undertakes to only allow persons to work on the system who:  are familiar with the basic work safety and accident prevention regulations and who have been instructed on how to handle the system.  The safety-conscious work of staff will be checked at regular intervals.

2.3 Obligations of the staff All persons tasked with working on the system undertake to perform the following before starting work:  Observe the basic work safety and accident prevention regulations  Read the safety chapter and the warning information in these operating instructions.

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

2.4 Hazards when using the system The system is constructed in accordance with the state of the art and the recognised safety regulations. However, problems with the system or other assets can arise during its use. The system may only be used:  for its intended purpose  when in a perfectly safe condition, see Appendix 1 Faults which can impair safety must be remedied immediately. The CeCon 3000 is tested in accordance with the EMC standards. Nevertheless, the influence of electromagnetic radiation on or from other units cannot be excluded fully

2.5 Explanation of the symbols

Warning Dangerous situation. If not avoided this my result in serious injuries. Printed on medical products, this sign may also mean “read the user instructions”

ATTENTION !

Means a potentially dangerous situation. If not avoided damages might be a result.

Important Under this symbol you will find user tips and particularly important information.

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

2.6 General information and recommendations 2.6.1 Maintenance In order to guarantee perfect functioning of the system, it is necessary to observe the maintenance intervals.

2.6.2 Operation The CeCon 3000 can start up and stop automatically, depending on the control system.

2.7 Hazards from electrical energy  Have work on the electrical supply carried out only by a trained electrician

 Check the system’s electrical equipment regularly. Loose connections and singed cables must be remedied immediately.

2.8 Maintenance, servicing, remedying faults  Carry out the stipulated maintenance work on time as described in Section 12 Maintenance.  Inform operating personnel before the start of maintenance and servicing work.  All system components upstream and downstream of the system, as well as operating media such as compressed air, water, and / or similar, must be safeguarded to prevent accidental putting into operation.  The mains plug must be pulled out before all repair work.  Check that the screw connections are secure. Check the function of the safety fixtures after completing the maintenance work.

2.9 Structural modifications to the system  Do not make any modifications, additions or conversions to the system without the manufacturer’s approval.  All conversion work requires written approval from the company DWA  Replace any system components which are not in a perfect condition  Use only original spare parts and wear parts.

–

With parts obtained from other sources, it is not guaranteed that they are designed and manufactured to meet the necessary stress and safety requirements.

2.10 Cleaning the system Cleaning the outside parts of the system  Use a soft cloth moistened with water and / or a standard household cleaning agent.  Remove dirt marks or dust.  Do not clean the system parts with easily volatile solvents such as thinner, benzene or chemical cleaning sprays. These could damage the system’s surfaces.

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

3 Transport 3.1 Dimensions and weight Width: ... 530 mm Height: ... 520 mm Depth: ... 200 mm Weight: ...

20-22 kg

3.2 Ambient conditions Temperature range storage and transport Operation Protect against frost!

+1 °C to + 50 °C +10 °C to + 35 °C

4 System data 4.1 Designation, type Designation:

Central concentrate supply system

Types: Sort / levels

CeCon 3000 1/1; 1/2; 1/3; 2/1; 2/2; 3/1

4.2 Advantages of the system The CeCon 3000 system    

simplifies work for maintenance staff by eliminating the need to handle canisters. reduces environmental damage thanks to reusable large containers instead of 10 litre-canisters improves the dialysis procedure by way of constant concentrate solutions reduces concentrate costs. Previously, concentrate residues from started canisters could no longer be used and were disposed of.

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

4.3 Technical Data Model Dimensions Measurements (WxHxD) Weight Performance data Supply capacity Power consumption Intake pressure min Intake pressure max. Max. supply pressure Ambient temperature max. Max. delivery head

CeCon 3000 530 / 520 / 200 mm 20-22 kg depending on type

40 l/h per concentrate type 250 W 0.01 bar 0.3 bar 2.5 bar 35 °C 25 m

Mechanical connections Container Supply Electrical connections Mains plug Mains voltage Fuses

Grommet D10 CPC coupling

Earthing-pin plug 230 V / 50 - 60 Hz Miniature circuit-breaker C16

Electrical safety (classification in accordance with EN 60601-1) Type of protection against electric Protection class I shock: Degree of protection against electric Type B shock: Degree of protection against the IPX2 penetration of liquid: Required raw water quality Intake temperature max. Permissible pH range

25 °C 2-12 pH

Consumables data (options) Pore size, pre-filter

Sterile filter, Ultrafilter

Installation requirements on the customer’s premises Connections: Container Hose D10 internal Supply CPC nipple

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

5 Setting up and putting into operation for the first time

Only authorised persons may enter the installation room !

5.1 Installation location, place of use The installation room for the CeCon 3000 must be designed as a wet room. Ensure that the installation room  is tiled if possible,  does not enable condensation water to form,  has sufficient ventilation,  has a relative humidity of no more than 90% at 20°C,  has a room temperature of between 10°C and 35°C

5.2 Setting up the system Avoid placing the unit down on sloped surfaces. Please refer to the installation plan on page 14 for the dimensions and connections.

5.2.1 Putting into operation The CeCon 3000 is put into operation by a DWA service technician and is ready for start-up when handed over to the operator.

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

5.3 Energy and supply connection data

5.3.1 Mains connection 230V / 50-60 Hz / 250 W

5.3.2 Remote Control As an option a remote control is available at DWA The potential-free alarm outputs of the system CeCon 3000 can also be connected to building monitoring systems. Electrical connection:

max.: 24V 3A

Error message line from the system to the remote display as a 7-core signal-cable (e.g. LIYCY 7 x 0,34 mm² or similar).

5.3.3 Concentrate container connection 7 x 1.5 mm hose with matching hose grommet (must be supplied by the container supplier for each container).

5.3.4 Waste water connection Floor drain near the system

5.4 Building-side preparations  The dialysis unit must be suitable for being operated with a concentrate pressure of 0.3 – 0.5 bar. The CeCon 3000 system cannot operate with systems tolerating no pressure at the input  The system supplies up to 60 dialysis (depends on the flow) units in one storey (on one floor). Also working on two or three levels is possible with the CeCon 3000 system extensions  In order to allow automatic container switchover, two containers of each concentrate type must be connected to the concentrate supply.

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

5.5 Installation plan

20

52

3

Cecon 3000

55

5

alle Maße in (cm) / all dimensions in (cm)

Elektrotechnik / electrics

Ringleitungsanschluß / loop IN/OUT Sanitärtechnik / sanitary

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Operating Instructions CeCon 3000

5.6 Method

5.6.1 Acetate / bicarbonate version The respective containers (see Installation Plan) are connected to the system via connection hoses. To enable the system to be filled, an automatic bleed facility with hose pumps is installed, via which the air is removed by suction. This also allows out-gassing of the bicarbonate components.

5.6.2 Switching contacts The pre-settling tank serves as a buffer vessel between the container and the ring line. Two switching points are defined via Reed contacts in the pre-settling tank.  Upper switching contact The pre-settling tank is filled with concentrate. The bleed pump is automatically switched on when the contact is left.  Lower switching contact When the contact is reached, the system automatically switches to the other container of the same concentrate type. The bleed pump stops simultaneously.

5.7 Container change The other container (the same line) is automatically put into operation when one container is completely empty. To guarantee fault-free concentrate delivery, the second container must be in a state of readiness, i.e. the system must be bled and acknowledged. When the system switches from one container to the other, a signal appears in the display field showing which container is empty. Connect a new full container. Slowly open the outlet valve of the container. Pressing the key automatically bleeds the system and resets the display.

5.8 Safety switching In the event of incorrect container changing or when both containers are emptied (one line), an alarm message is output and the line is switched off. After a new, filled container is connected, the system must be bled by pressing This acknowledges the alarm.

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

6 Operation

0/I

Reset

Test

Info

6.1 Dialysis operation

Press this key, the system is active

CONCENTRATE SUPPLY SYSTEM -- SYSTEM ACTIVE -SELECT WITH „TEST"

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Operating Instructions CeCon 3000

6.2 End of dialysis

Press this key, the system is in Standby

CONCENTRATE SUPPLY SYSTEM --- S T A N D B Y --SELECT WITH „TEST"

6.3 List of Alarms alarm

possible reason

actions

Press. alarm pipe x

pressure is higher than the preset pressure.

Check sensor pipe x

the pre-set pressure cannot be reached. the quoted container is empty

acknowledge alarm, if fault appears more often, contact DWA service check pump and pressure sensor. Change container; acknowledge alarm. Change containers; acknowledge alarm. Check hose to container

Container x empty Line x switched off Container x vent.alr

both containers of one line are empty. the line was disabled. hose to container blocked

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

7 Operating Parameters 7.1 Selection with TEST Test

Pressing this key enables the current operating values to be read off

01 Operating values

3.Level

2.Level

1.Level

Container 1 and 2

Displays container-status and pump-pressures

Pressure [bar]

1 2 P1 P2 P3 Type 1 1 # # #.## #.## #.## 2 2 # # #.## #.## 3 # # #.## 3

Status Container * aktive + ready (filled) - empty : Vent. active

Example: System Configuration 2 Types, 1 Level 1 2 P1 P2 P3 1 + * 0.50 -.-- -.-2 * - 0.60 -.-3 - - -.-B-Values

1. Type: Container 1 is in Standby, Container 2 is in use (= active), actual supply pressure is 0,5 bar 2.Sorte: Container 1 active, Container 2 is empty. supply pressure 0,6 bar

Lines not used with the actual system configuration are marked with “-“

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

02 Pump capacity Displays pump pressures and required pump capacity The pump capacity shows the actual capacity of a concentrate-line 1. level

2.level

3.level

P1 % P2 % P3 % Type 1 #.# ## #.# ## #.# ## " 2 #.# ## #.# ## #.# ## P-cap. " 3

Example: System Configuration 1 Type, 2 Levels P1 % P2 % P3 % 0.5 17 0.9 34 -.- --.- -- -.- --.- -P-cap.

1.Level: actual pressure 0,5 bar; pump capacity 17% 2.Level: actual pressure 0,9 bar; pump capacity 34%

When pump capacity is 100%, “**” is displayed

03 System control Settings of the timer for the actual and the following day On/Off

12:38:05 On Off tday Mon ##.## ##.## tmor Tue ##.## ##.##

current time

With a value 00.00 selected no On / OFF timer is activated

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DWA GmbH & Co. KG

Operating Instructions CeCon 3000

04 Operating hours RUNNING HOURS -------------------Voltage on ##### h System act. ##### h

Whole hours displayed only

Voltage On: Total time (in hours) for which the system is connected to the power supply. System active: Total operating time of the system (in hours)

05 Setpoint pressure P1 P2 L1: #.## L2: #.## L3: #.##

P3 #.## #.## #.## Set pts P

Pre-set pressures values stored in the list limit values

06 Control factors

P: ##.# I: ##.# D: ##.# N: ##.# Set pts CF

Pre-set pump control parameters stored in the list limit values PID Algorithm; N = neutral zone, when active, pump capacity never goes below this value

07 System-Info SYSTEM - INFO -------------------Software: ##.##.## Structure: ########

Software: Structure:

Compilation date The DIL switch settings (control board - centre)

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