Nipro NRO-MED-IFU-1001 Operator´s Manual

Operator´s Manual

RO MEDICAL

Description: NRO-MED-IFU-1001

Date: 06.10.2021 | Version: 12

Written by: Nipro Pure Water

Version 12| 06.10.2021 | Page 3

Table of Contents

1 General .............................................................................................. 6

1.1 Scope of supply ................................................................................... 6

1.2 Unit combinations ................................................................................ 6

1.3 Notes for the Operator.......................................................................... 6

1.4 Laws and Standards ............................................................................. 6

1.5 Symbols used in this Manual ................................................................. 7

1.6 Transport and Storage .......................................................................... 7

1.7 Model Plate ......................................................................................... 8

1.8 Warning on the Unit. ............................................................................ 8

1.9 Shutdown ........................................................................................... 8

1.10 Disposal.............................................................................................. 9

1.11 Instruction / Further Documentation ...................................................... 9

1.12 Duration of usage ................................................................................ 9

2 Intended operation ............................................................................. 10

2.1 Contraindications / side effects ............................................................. 11

3 Safety ............................................................................................... 11

3.1 Risk Assessment ................................................................................. 11

3.2 EMC .................................................................................................. 11

3.3 Emissions .......................................................................................... 11

4 Technical Data .................................................................................... 12

5 Description of the device ..................................................................... 13

5.1 Flow-Chart ......................................................................................... 13

5.2 Functional sequence ............................................................................ 14

5.3 Safety devices / Components ............................................................... 15

6 Installation......................................................................................... 16

6.1 Environmental Condition ...................................................................... 16

6.2 Assembly ........................................................................................... 16

6.3 Electrical installation ........................................................................... 17

6.4 Prefiltration (Example) ........................................................................ 18

6.5 Commissioning ................................................................................... 19

6.6 Initial commissioning ........................................................................... 20

7 Operation .......................................................................................... 21

7.1 Control Panel ..................................................................................... 21

7.2 System on / off without permeate tank .................................................. 22

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7.3 Device on / off with permeate tank ....................................................... 23

7.4 Emergency operation .......................................................................... 24

7.5 Operating displays .............................................................................. 25

8 Error messages / troubleshooting ......................................................... 26

8.1 Error messages .................................................................................. 26

8.2 Clear alarms....................................................................................... 26

9 Maintenance and cleaning .................................................................... 27

9.1 External Cleaning ................................................................................ 27

9.2 Maintenance Intervals ......................................................................... 28

9.3 Chemical Disinfection .......................................................................... 29

9.4 Microbiological Inspection .................................................................... 30

10 Display / Parameter ............................................................................ 31

10.1 Retrieval of the operating hours / conductivities ..................................... 31

10.2 Change the conductivity parameter ....................................................... 32

10.3 Change parameter temperature ............................................................ 33

Technical appendix ........................................................................................ 34

11 Replacement of the reverse osmosis membrane ..................................... 35

12 Service Parameters ............................................................................. 36

12.1 Adjustment of the conductivity ............................................................. 37

12.2 Setting date and time .......................................................................... 37

12.3 Summer / winter time ......................................................................... 37

12.4 Auto Start (Timer) .............................................................................. 38

12.5 Service point ...................................................................................... 39

13 Disinfection ........................................................................................ 40

13.1 Disinfection Protocol ............................................................................ 43

14 EMC manufacturer's declaration ............................................................ 44

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0297

Foreword

For the reverse osmosis type RO medical, conformity according to EC directives is declared

This Operator’s Manual includes all information required for the installation and operation for the reverse osmosis model RO medical. Please keep this Operator’s Manual readily available and near the unit.

This Operator’s Manual applies for the units with the serial number:

Nipro Pure Water GmbH Werner-von-Siemens-Str.2-6 76646 Bruchsal –

Tel.: 0049 7251-32 19 7810

Rev# Date / Name Description

1 16.05.11 / N.Bürkle First edition 2 07.07.11 / N.Bürkle Disposal added 3 31.08.11 / N.Bürkle Disinfection added 4 28.02.12 / N.Bürkle Limit values added 5 28.02.14 / N.Bürkle Company name 6 20.12.19 / N.Bürkle New Design / EMC 7 10.01.20 / N.Bürkle Air pressure added 8 29.06.20 / N.Bürkle Changes accord. EN 60601 9 29.06.20 / N.Bürkle LOGO Control 10 24.02.21 / T. Barretto Cosmetic corrections 11 03.03.21/ R.Tille Water pressure input 12 06.10.21/G.Biscardi Information Service point

1 General

1.1 Scope of supply

The scope of delivery includes the following parts:

 1 reverse osmosis  1 connection set

1.2 Unit combinations

The unit model RO may be combined with the following devices:

 * Permeate tank  * City water tank

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1.3 Notes for the Operator

The operator is responsible for:

 Competent and intended operation  Compliance with work safety and accident prevention provisions  Technical instruction of operating personnel

1.4 Laws and Standards

The following laws and standards are adhered to:

 Council Directive 93/42 EEC Medical Devices  EN 60601  DIN EN 1717 Protection of potable water against contamination

1.5 Symbols used in this Manual

Stands for a dangerous situation. Disregard can result in personal injury or material damage.

Stands for information and valuable tips.

1.6 Transport and Storage

Protect unit against frost and moisture

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Protect against strong jolting and collisions.

Only move unit upright and with an appropriate lift.

The system may be stored for a maximum of 1 year.

1.7 Model Plate

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IPX 4

Manufacturer

Attention, take note of accompanying documents

CE mark with the number of the notified body. Here DQS

Protection against the ingress of liquids. Here splash-water protection

Protection Scheme according to EN 1717. Here free outlet

Serial number

Year of construction

Pay attention to manual

1.8 Warning on the Unit.

Caution voltage. Turn mains switch off before opening housing. Fixed on control cabinet.

1.9 Shutdown

If a unit is shutdown for more than 5 days, conservation will be necessary.

Please contact Nipro Pure Water before performing conservation.

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1.10 Disposal

Regarding the WEEE guidelines of the European Union, the disposal of electronic devices and electronic sub-assemblies and parts into the general garbage is not lawful. These parts must be disposed environmentally appropriate:

If not appointed otherwise and no private disposal management is available, these devices or possibly other environmental hazardous items can be sent back.

The filters and membrane can be disposed via the general garbage

1.11 Instruction / Further Documentation

The using personnel must be warned against the hazards during operation and must be warned against the hazards of misusing the product.

The personnel gets the instruction of operation and the specialties of usage. Instructed adult only are allowed to operate this device.

This instruction by the manufacturer or authorized personnel takes place during the commissioning of the device.

Further trainings are not necessary for this device.

For qualified personnel the following documents can be made available upon request.

Circuit diagrams Spare parts list

1.12 Duration of usage

The device is designed for a use of 10 years

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 Serious soiling

2 Intended operation

The unit is designed for the treatment of potable water. The pure water (permeate) thus produced may be used for dialysis treatment.

Other applications are only possible after consulting the manufacturer and receiving their approval.

The unit can only be maintained by the manufacturer or technicians trained by the manufacturer.

Only original replacement parts may be used for maintenance and repairs.

Installation operations, modifications or reparations, are only allowed to be performed by persons authorised by the manufacturer and may only be done with original replacement parts. Improper performed reparations or modifications can lead to hazards to the user and/or may damage the device.

The device may only be operated in perfect condition. Before operating, check the following:

 Lose or defect parts  Defect cables and/or isolations

The device may only be operated with the appropriate ring line.

The device does not produce water for injections.

The device has pressurized parts.

If the temperature sensor fails, the temperature in the permeate can increase. (Max 60°C)

The water treatment system RO medical may only be used for permeate supply of dialysis devices, which have a temperature measurement (permeate temperature).

The device has no direct patient contact and no patient application part.

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2.1 Contraindications / side effects

None

3 Safety

3.1 Risk Assessment

There will be no dangers associated with the reverse osmosis model RO medical D if the operating instructions are followed.

The device can automatically start by way of an auto-start.

3.2 EMC

The device was developed and tested in accordance with current standards. Nevertheless, influence through electromagnetic fields cannot be completely excluded.

3.3 Emissions

The device does not produce dust or vibrations. The noise level is under 609 dB (A).

4 Technical Data

Temperature

1 Membrane

2 Membranes

3 Membranes

4 Membranes

15° C

350 l/h

700 l/h

1050 l/h

1400 l/h

Quality

Potable Water

Hardness

< 1 °dH

Silicate

< 25 mg/l

Chlorine

< 0,1 ppm (mg/l)

Iron < 0,1 ppm (mg/l)

Fouling Index (S.D.I)

< 3 Temperature

5-25°C Pressure

3 bar

Water feed

1”

internal thread

Pure water connection

Hose nozzle d20

Drain

HT 4

Supply voltage

220-230 V, 1 Phase,

50/60 Hz

Fuse

Automat 16 A

-K,

Fi ΔI 30mA

Current consumption

9,9 A

x 60 Hz

Degree of pollution

Storage / transport

40°C

Operation

10-

35°C

Air pressure

795-1062 hPa

Conductivity

1000 µS/cm ±5%

100-1000 l/h

RO Medical

1000x500x1

Permeate performance

Inlet water

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Connections

Electrical data

Ambient temperature

Display system

pressure switch 0-10 bar ±5%

Flow (sight glass) 300-3000 l/h ±5%

Size

5 Description of the device

5.1 Flow-Chart

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1. Magnetic valve inlet

2. Pressure switch input

3. Disinfection point

4. Conductivity input

5. Pump (pressure 10-13bar)

6. Manometer (pressure 10-13 bar)

7. Reverse osmosis membrane (1-4 pieces)

8. Permeate flow rate indicator

9. Temperature sensor

10. Conductivity probe permeate flow

11. Permeate pressure switch

12. Connection back flow hose nozzle d20

13. Connection back flow hose nozzle d20

14. Conductivity ring back flow

15. Discard three-way ball valve permeate

16. Check valve

17. Flow indicator concentrate outflow

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5.2 Functional sequence

If the toggle switch is turned to the ‘On‘ position, the magnetic valve (1) opens and water flows into the system. After a short delay, the pump (4) will start. Now the water is pressed into the reverse osmosis membrane at a pressure of 10-15 bar. The flow is divided into a permeate and a concentrate part. The permeate content flows through the flow indicator (7), the temperature sensor (8), the conductivity probe (9) and the pressure switch (10) into the ring line. The unused permeate flows back into the RO medical via the connection (12). To save water, the concentrate portion is divided up again, one portion is given into the drain via the flow indicator (17), the other is fed back in front of the pump.

5.3 Safety devices / Components

Inlet

Mode switch

Connection

Turn on key

Pressure switch

Permeat Flow

Pressure Switch Inlet

Pressure tube with membrane

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Display

Main switch

Service Point

Flow Display Concentrate

Flow Display Permeat

Raw water connection

Magnetic valve

Conductivity Probe Inlet

Disinfection port

Emergency

Fault signal lamp

Manometer Pump pressure

Pressure pump

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