modula S-XL Operating Manual sw ver 2.09 Nov 2015

Content: Explanation of the symbols used ...5 1

Preliminary remarks ...5

2 General information ...6 2.1 Applied directives, laws, standards ...6 2.2 Terminological definitions...6 2.3 Purpose ...6 2.4 Intended use ...7 2.5 Obligations of the plant operator ...7 2.6 Qualification of the operating personnel ...7 2.7 Packaging and shipping ...8 2.8 Scope of supply...8 2.9 Spare parts ...9 2.10 Disposal ...9 2.11 Supplementary documentation ...9 2.12 Optional accessories ...10 2.12.1 Water Guard...10 2.12.2 Water Protector ...10 2.12.3 Remote control ...10 2.12.4 Modem kit...10 2.12.5 External hardness measurement ...10 2.13 Consumables ...10 3 3.1 3.2 3.3 3.4 3.5 3.6

Safety instructions ...11 Overall hazard assessment ...11 General safety information ...11 Hazards caused by electrical energy ...11 Emissions ...11 Electromagnetic compatibility ...12 Safety devices ...13

4 4.1

Labelling ...14 Symbols on the nameplate and their significance ...15

5 Specifications ...16 5.1 Technical data ...16 5.1.1 Versions ...17 5.1.2 Possible unit combinations ...17 5.1.3 Performance data...18 5.1.4 Module array ...19 5.1.5 Dialysis water quality and conductivity ...21 5.1.6 Microbiology ...21 5.2 Flow chart ...22 5.3 Functional description ...24 5.4 Unit views ...25 5.5 Sensors and valves ...28 6 6.1 6.2

Installation ...29 Installation site requirements ...29 Positioning requirements...29

7 7.1 7.2

Commissioning ...30 Initial start-up ...30 Restart after initial start-up ...30

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8 Operation ...31 8.1 Control panel ...31 8.1.1 Key functions...32 9 9.1 9.2 9.3 9.4 9.5 9.6

Operating modes ...33 STANDBY ...33 DIALYSIS ...33 RINSING ...34 LOCKED ...35 DISINFECTION ...36 ERROR ...37

10 Retrieving information ...38 10.1 INFO menu ...38 10.1.1 Info screen: SYSTEM ...39 10.1.2 Info screen: PRESSURE ...40 10.1.3 Info screen: FLOW ...40 10.1.4 Info screen: TEMPERATURE ...41 10.1.5 Info screen: CONDUCTIVITY ...42 10.1.6 Info screen: DIGITAL INPUTS ...43 10.1.7 Info screen: DIGITAL OUTPUTS ...43 10.1.8 Info screen: SYSTEM INTERFACE ...44 10.1.9 Info screen: STATISTICS ...45 10.1.10 Info screen: ALARM LIST ...45 10.2 SERVICE menu ...46 10.2.1 Service dialogue: ACCESS ...47 10.2.2 Service function: SERIAL OFF ...47 10.2.3 Service function: PREFILTER CHANGE ...47 10.2.4 Service function: SENSOR NIV1 ...47 11 Maintenance and servicing ...48 11.1 Inspection intervals ...48 11.2 External cleaning ...48 11.3 Replacing the pre-filter cartridges ...49 11.4 Sampling to determine the bacterial count...49 12 Faults and messages ...50 12.1 Critical faults with unit shutdown ...50 12.1.1 Switching action in the event of Water Guard alarm...52 12.2 Faults without unit shutdown ...53 12.3 Messages ...55 13 Emergency operation...56 13.1 Starting and stopping the emergency mode ...56 13.2 Failure of dry run protection device Niv1 ...57 Inventory...58 Daily log ...59

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Explanation of the symbols used Refers to a hazardous situation. Failure to avoid this situation may result in personal damage including serious personal injury.

Refers to a potentially hazardous situation. Not acting cautiously may result in material damage.

Refers to useful information and important notes within the respective context.

Indicates upper and lower temperature limits.

Symbol for separate disposal of electrical and electronic devices as well as having been placed on the market after 13 August 2005.

Caution! Mains voltage!

1

Preliminary remarks

This operating manual provides all users with instructions necessary for the safe and reliable operation of the unit. It is an important document, an aid in operating and servicing the installation and contains fault remediation procedures. Please read this operating manual, comply with the instructions provided and make sure this manual is always at hand on the unit.

Read the operating manual before operating or servicing the unit!

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2

General information

2.1

Applied directives, laws, standards



Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices



DIN EN 61010-1 Safety requirements for electrical equipment, for measurement, control and laboratory use – part 1: General requirements



DIN 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

2.2

Terminological definitions

Permeate:

Water with a limited amount of compounds which is produced by pre-treatment and reverse osmosis units.

Dialysis water:

Treated water meeting the requirements of ISO 13959 and suitable for haemodialysis and similar applications (source: ISO 23500).

Concentrate:

Water with an increased amount of compounds which is retained as retentate on the feed side of the membrane within the separation process.

RO

means “reverse osmosis unit”.

The present application uses permeate as dialysis water. Within this document, the term "permeate" refers mainly to technical application aspects, whereas "dialysis water" generally refers to the final product used for medical therapy.

2.3

Purpose

The modula S-XL reverse osmosis unit produces dialysis water and supplies it through a pipe system (ring main for dialysis water) to connected dialysis devices. Dialysis water is recovered through a membrane separation process called reverse osmosis.

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2.4

Intended use

The modula S-XL reverse osmosis unit may only be used for production and supply of dialysis water. Other applications, in particular the use of media other than those mentioned in the specifications, may lead to hazardous situations and must thus be refrained from in all cases! Any other use will be considered as not intended. The same is true if the unit is operated with defective safety devices or if installation, start-up, operation and servicing of the installation is carried out improperly. DWA GmbH & Co. KG shall not be liable for damages resulting from unintended use. Performance modifications to the installation as well as the use of third-party spare parts must be checked and approved by DWA. Intended use includes compliance with the prescribed operating and maintenance instructions.

2.5

Obligations of the plant operator

Generally, the operator is responsible for 

choosing the components of the water treatment and distribution system,



the compatibility of the individual components,



compliance with the safety regulations and taking precautionary work safety and accident prevention measures,



the correct use of the unit by instructed personnel,



the professional training of the operating personnel at the installation and their initiation to the operating instructions,



keeping of an inventory,



and the timely completion of recurrent safety checks by trained and qualified technical staff (called maintenance personnel in the following).

2.6

Qualification of the operating personnel

The operating personnel must be initiated in the operation and the particularities of the unit. Only initiated persons of legal age are allowed to operate the unit! The initiation by the manufacturer or the maintenance personnel shall take place during start-up of the installation and when required. Other training is not necessary to operate the unit.

The maintenance personnel is trained exclusively by DWA and receives, upon termination of the training, a certificate that is valid two years and entitles the holder to start-up, maintain, and repair the unit as well as to check the electrical safety.

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2.7

Packaging and shipping Adhere to the accident prevention regulations and handling instructions on the package! Do not toss nor put weigh onto the package! Packing: 1450 x 800 x 1900 (L x W x H) mm, weight: 375 kg max.

Protect from frost or heat! Storage and shipping at +1 °C to +45 °C

If condensation occurs during shipment between two places with different ambient temperature and high humidity, the inside of the unit must dry before the unit may be switched on! Let the unit dry at 25 °C for at least 36 h.

2.8

Scope of supply

The scope of supply of the modula S-TP reverse osmosis unit includes the following parts: 

the complete unit according to the order

and the following parts: No. Quantity

Unit

Item no.

1

1

unit

SO8CMOX1E

Operating manual modula S-XL

2

3.00

meter

ZG05AL025

Hose 39x7 mm (DN 25)

3

6.00

meter

ZG05AL020

Hose 31x6 mm (DN 20)

4

8

units

ZG05V2032

Hose clamp 20-32 mm

5

8

units

ZG05V2540

Hose clamp 25-40 mm

6

1

unit

SO8B98063

Customer interface

7

1

unit

SO8C15045

Wastewater hose 1.5 m RO

8

1

unit

ZG01HT450

HT pipe bend (PP) DN 50 / 87°

9

2

units

ZG01P2325

Male/female union 25+32 PVC-U

10

2

units

ZG01P1625

Hose connector D25

11

1

unit

20KSET110

Permeate sampling kit (contains 6 sampling bags and accessories)

12

1

unit

SO8BXLBOX

Spare fuses box for modula S-XL

13

2

units

FILT05020

Pre-filter cartridge 5 µm 20''

14

1

unit

YY0000003

Pre-filter housing wrench

15

1

unit

ZG01HKS11

Hook key for DIN 11851 DN15

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Designation

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2.9

Spare parts

The spare parts list is available to the maintenance personnel in the Service documentation for modula S-XL. The use of third-party spare parts may impair the intended use of the unit and must thus be checked and approved by DWA.

2.10

Disposal The implementation of the 2002/96/EC Directive via the WEEE Directive of the European Community means that the disposal of obsolete electrical equipment as well as electronic and electrical assemblies with domestic waste is no longer permissible. These parts must be disposed of in an environmentally sound manner! Unless otherwise agreed with DWA or if a private waste management system is not available, DWA equipment and any environmentally hazardous parts thereof can be resent to DWA.

2.11

Supplementary documentation

Detailed information about installation, start-up, maintenance and repair is available to the maintenance personnel for the modula S-XL reverse osmosis unit in the Service documentation for modula S-XL.

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2.12

Optional accessories

2.12.1

Water Guard

The Water Guard is a leakage sensor in the osmosis room. It can be mounted upstream the pretreatment units (pressure regulator, backflow preventer, filters, softener, etc.) in order to isolate these components from the water supply system in case of water leakage.

2.12.2

Water Protector

The Water Protector serves as a leak monitor in the dialysis room and sends an alarm in case of water leakage. When the unit is in unattended rinsing mode, the Water Protector may switch off the whole system network in case of leakage.

2.12.3

Remote control

The remote control can be used to switch the DWA system network on and off from a central control room. It also provides a display for the status or a message.

2.12.4

Modem kit

The reverse osmosis unit has two serial ports for data logging and remote maintenance. The ports are located at the bottom of the control cabinet.

2.12.5

External hardness measurement

Protects the RO membranes in the event of a hardness breakthrough.

For more information about optional accessories, please contact your DWA field representative.

2.13

Consumables



FILT05020:



20KSET110:

Pre-filter cartridge 5 µm 20'' Permeate sampling kit (contains 6 sampling bags and accessories)

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3

Safety instructions

3.1

Overall hazard assessment

The unit is state-of-the-art and complies with the requirements of the EC directive and the standards on medical devices.

If the unit is used as intended, it presents no hazards.

Malfunctions impairing intended use must be remedied immediately.

3.2

General safety information



Never bypass or bridge safety devices!



Never cover the unit or parts thereof!



Do not put any combustible items near or on top of the unit.



In case of unusual noise, odours, or leakage, monitor the unit, separate it from the mains and call the maintenance personnel!



Immediately report defective hoses or connections to the maintenance personnel!

3.3

Hazards caused by electrical energy The electrical safety of the unit must be checked at least once per year during the recurrent test!

3.4

Emissions

The unit does not produce any dust or vibrations. The measured noise level is below 70 dB (A). Personal noise protection measures are thus unnecessary.

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3.5

Electromagnetic compatibility

Medical electrical equipment is subject to special precautionary measures with respect to electromagnetic compatibility (EMC) and must be installed and put into operation according to the instructions in the accompanying documentation. Information about EMC in compliance with DIN EN 60601-1-2 section 5.2.2 is given in the Service documentation for modula S-XL.

The modula S-XL reverse osmosis unit has been tested and is protected according to the requirements and recommendations of DIN 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 HF communication equipment may affect medical electrical equipment.

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3.6

Safety devices

Safe handling of the unit is provided by the following safety devices mounted at the unit: (1) Power switch for mains isolation (2) Automatic circuit breakers and micro fuses in the control cabinet (3) Conductivity measuring device Ci4 for product quality monitoring (4) Pressure measuring device Pi4 for permeate pressure monitoring (5) Overflow valve protecting the dialysis units from pressure peaks in case of malfunction (6) Temperature measuring device Ti1 protecting the unit from overheat (7) Lockable castors (8) Dry run protection device Niv1. Caution! Mains voltage!

1

2

8 3

4

5

6

7

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4

Labelling The nameplate is located on the left side of the control cabinet

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: yy MODXL #### yy: Year of manufacture 20yy MODXL: Device identification ####: consecutive number The version label (A) states the permissible mains voltage, mains frequency and the rated current consumption of the device:

or

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4.1

Symbols on the nameplate and their significance Symbol for "reference/item number".

Symbol for "serial number".

3N~

Type of supply, in this case: three-phase alternating current with neutral conductor. Symbol for "conformity with the Directive 93/42/EEC" concerning medical products. The following number identifies the notified body, in this case: 0044.

IPX4

Statement of the protection type, in this case: protection against splashed water from all sides.

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

Specifications

5.1

Technical data

modula S-XL

Performance data

Water connections

Electrical data

Electrical safety

Feed water

Ambient conditions

On-site requirements

Designation

Specification

Dimensions (L x W x H)

1270 x 690 x 1620 mm

Weight of modula S-XL 4 (dry / operating) modula S-XL 10 (dry / operating)

278 / 376 380 / 502

Dialysis water output

up to 1650 l/h

at 10 °C and 2.5 bar backpressure

(s. section 5.1.3 and following)

Permeate pressure

2 to 5 bar

Retention rate

> 99 % NaCl

Yield

up to 85 %

Feed water inlet

Connector for hose DN25 or Screw connection 5/4” male

Dialysis water

Connector for hose DN20 or DIN 32676 - DN25

Mains plug

CEE 32 A (3L+N+PE, 6h

Mains voltage depends on type (see section 5.1.1)

400 V 3~(N) / 50 Hz or 400 V 3~(N) / 60 Hz

Energy consumption

6.5 kW

Fuse

25 A / Fi ΔI 30 mA

Protection class

I

Overvoltage category

II

Contamination level

2

Ingress Protection Rating

IP X4

Quality

Softened drinking water

Hardness

< 0.1 °dH (0.018 mmol/l)

Fouling index / SDI

<3

Conductivity

1400 µS/cm

Iron

< 0.05 mg/l

free Chlorine

< 0.1 mg/l

Temperature range

5 to 30 °C

pH

6.5 to 8.5

Temperature

- Shipping / storage - Operation

+1 to +45 °C +1 to +35 °C

Humidity

max. 90 % rel.humidity, non-condensating

Installation altitude

max. 2000 m above NHN

Isolable water supply,

Pressure reducing valve or pressure booster as required

for full upgrade 6 m3/h at 3 to 6 bar dyn.

Drain max. 50 cm above floor level

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HT50 pipe, for 6 m3/h, by gravity

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5.1.1

Versions

The reverse osmosis unit modula S-TP is available for two mains voltage versions:  

5.1.2

REF 01MODULASXL4 - ..01MODULASXL10: 400 V AC 50 Hz and REF 01MODULASXL4C - ..01MODULASXL10C: 400 V AC 60 Hz.

Possible unit combinations

The reverse osmosis unit modula S-XL can be operated in combination with other equipment. After modifications made to a component to the water purification and distribution system, suitable tests should be performed to prove conformity to system requirements.

down-stream heat disinfection systems All DWA heat disinfection systems can be used as down-stream unit. Devices from other manufacturers may be operated under certain conditions. Please contact your DWA field representative.

Connected heat disinfection systems shall meet the requirements of the standards IEC 61010-1, IEC 60601-1 or equivalent.

Dialysis water ring mains: The reverse osmosis unit modula S-XL shall only be operated with dialysis water ring mains from media resistant and heat resistant materials. The following materials are suitable and approved: 

PE-Xa (cross-linked polyethyelene)



PVDF (poly vinylidene fluoride)



stainless steel (1.4401, 1.4404, 1.4571  AISI 316, AISI 316L, AISI 316Ti)

Ring mains made from PVC have only limited resistance. PVC piping is not suitable for operating heat disinfection systems.

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5.1.3

Performance data The following nominal performance data refer to 10 °C and a back pressure of 2.5 bar when in MAXIMAL mode.

Model

Permeate output

modula S-XL 4

1400 l/h

modula S-XL 5

1750 l/h

modula S-XL 6

2100 l/h

modula S-XL 7

2400 l/h

modula S-XL 8

2700 l/h

modula S-XL 9

3000 l/h

modula S-XL 10

3300 l/h

Table for permeate output calculation at different temperatures: In order to estimate the permeate output at temperatures other than 10 °C, please use the correction factors given in the following table and calculate the actual output as explained in the example.

Temperature °C

Correction factor

Temperature °C

Correction factor

Temperature °C

Correction factor

1

0.62

11

1.04

21

1.46

2

0.66

12

1.08

22

1.51

3

0.70

13

1.13

23

1.54

4

0.74

14

1.16

24

1.59

5

0.79

15

1.21

25

1.64

6

0.84

16

1.26

26

1.69

7

0.87

17

1.30

27

1.74

8

0.92

18

1.33

28

1.79

9

0.95

19

1.39

29

1.85

10

1.00

20

1.43

30

1.89

Example: Nominal permeate output of a modula S-XL 5 at 17 °C? Output at 10 °C: Correction factor at 17 °C:

1750 l/h 1.30

 Nominal permeate output at 17 °C and 2.5 bar permeate pressure: 1750 l/h x 1.30 = 2275 l/h

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5.1.4

Module array

The lowest expansion level of modula S-XL comprises four modules. If the unit is expanded to an uneven number of modules, it is always the module package 2 (inner) that has the larger number of modules.

The following table provides an overview of the possible expansion levels and permeate outputs (at a water temperature of 10 °C and a back pressure of 2.5 bar): Top view

Designation

Capacity

Total

Redundance / ECOMODE

Module package 1 (outer)

modula S-XL 4

1: 2 x 350 l/h 2: 2 x 350 l/h

1400 l/h

700 l/h 700 l/h

Module package 2 (inner)

modula S-XL 5

modula S-XL 6

1: 2 x 350 l/h 2: 3 x 350 l/h

1: 3 x 350 l/h 2: 3 x 350 l/h

700 l/h 1750 l/h

2100 l/h

1050 l/h

1050 l/h 1050 l/h

1: 3 x 350 l/h modula S-XL 7

modula S-XL 8

modula S-XL 9

modula S-XL 10

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2: 3 x 350 l/h 1 x 300 l/h

1: 3 x 350 l/h 1 x 300 l/h 2: 3 x 350 l/h 1 x 300 l/h 1: 3 x 350 l/h 1 x 300 l/h 2: 3 x 350 l/h 2 x 300 l/h 1: 3 x 350 l/h 2 x 300 l/h 2: 3 x 350 l/h 2 x 300 l/h

2400 l/h

1050 l/h 1350 l/h

2700 l/h

3000 l/h

3300 l/h

1350 l/h 1350 l/h

1350 l/h 1650 l/h

1650 l/h 1650 l/h

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The following combinations are also possible, especially for units with operation varying between partial and full load. Top view

Designation

Capacity

Total

Redundance / ECOMODE

Modulpaket 1 (außen)

1: 2 x 350 l/h modula S-XL 6

2: 3 x 350 l/h 1 x 300 l/h

2050 l/h

700 l/h 1350 l/h

Modulpaket 2 (innen)

1: 2 x 350 l/h modula S-XL 7

2: 3 x 350 l/h 2 x 300 l/h

700 l/h 2350 l/h

1: 3 x 350 l/h modula S-XL 8

2: 3 x 350 l/h 2 x 300 l/h

2700 l/h

1650 l/h

1050 l/h 1650 l/h

The modula S-XL reverse osmosis unit can be set to three different basic operating modes.

Basic mode REDUNDANT In REDUNDANT mode one of the two module packages is used as a reserve, so that dialysis can be continued even if components should fail. A 100 % redundancy of the dialysis water output capacity is given if the number of modules per package is identical.

Basic mode MAXIMAL In MAXIMAL mode both module packages are running in parallel in order to maximise the permeate production.

Basic mode ECOMODE The ECOMODE mode allows consumption-controlled dialysis water production. During operation, the unit constantly monitors dialysis water consumption and turns on and off the corresponding module packages as required.

In REDUNDANT and ECOMODE operating modes, unused module packages are rinsed automatically after longer idle times.

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5.1.5

Dialysis water quality and conductivity

The dialysis water quality depends primarily on two factors: the chemical composition of the feed water and the microbiological condition of the whole system (pretreatment, reverse osmosis, dialysis water ring main, etc.) and the maintenance of the latter. Reverse osmosis membranes retain a high proportion of the contaminants in the feed water. However, a few ions are always able to pass through the membranes. The dialysis water conductivity thus depends on the feed water quality.  

The conductivity of the feed water limits the attainable dialysis water conductivity. A higher concentrate discharge rate (higher water consumption) can decrease the dialysis water conductivity.

Carry out regular chemical analyses of the feed and the dialysis water in order to become aware of changes in time and to be able to take appropriate measures.

5.1.6

Microbiology

There are microbial load limits for dialysis water. In general, new units can easily comply with these values. Reverse osmosis membranes almost completely retain germs, and microbial growth is reduced to a minimum through automatic idle time rinsing. However, there is a certain risk of retrograde contamination, e.g. coming from the connection ports at the bed head media panels, so that bacteria can be detected in the ring main as well as in the dialysis water.

Therefore, carry out regular microbe and endotoxin tests and use suitable disinfection measures if contamination is detected. See also Section 11.4 "Sampling to determine the bacterial count".

Avoid long idle times in order to minimise bacterial growth.

Perform regular heat disinfections of the ring mains to kill bacteria and to avoid biofilm growth.

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