Nipro RO medical User manual

Operator´s Manual
RO MEDICAL
Description: NRO-MED-IFU-1001
Date: 06.10.2021 | Version: 12
Written by: Nipro Pure Water

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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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Foreword
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:
© Copyright 2021
Nipro Pure Water GmbH
Werner-von-Siemens-Str.2-6
76646 Bruchsal –
Tel.: [phone] 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
For the reverse osmosis type RO medical, conformity according to
EC directives is declared
0297

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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
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

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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
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.

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1.7 Model Plate
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.
Attention, take note of
accompanying documents
CE mark with the number of
the notified body. Here DQS
IPX 4
Protection against the
ingress of liquids. Here
splash-water protection
Protection Scheme according
to EN 1717. Here free outlet
Serial number
Year of construction
Manufacturer
Pay attention to manual

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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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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

Serious soiling
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).

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4 Technical Data
Permeate performance
Temperature
1 Membrane
2 Membranes
3 Membranes
4 Membranes
15° C
350 l/h
700 l/h
1050 l/h
1400 l/h
Inlet water
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
1
-
3 bar
Connections
Water feed
1”
internal thread
Pure water connection
Hose nozzle d20
Drain
HT 4
0
Electrical data
Supply voltage
220
-
23
0
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
1
Ambient temperature
Storage / transport
3
-
40°C
Operation
10
-
35°C
Air pressure
795
-
1062 hPa
Display system
Conductivity
0
-
1000 µS/cm ±5%
pressure switch 0-10 bar ±5%
Flow (sight glass) 300-3000 l/h ±5%
100
-
1000 l/h
Size
RO Medical
1000x500x1
64
0

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5 Description of the device
5.1 Flow-Chart
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.

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5.3 Safety devices / Components
Pressure switch
Magnetic valve
Inlet
Conductivity Probe
Inlet
Pressure pump
Manometer
Pump pressure
Main switch
Emergency
Mode switch
Fault signal lamp
Display
Disinfection port
Flow Display
Permeat
Flow Display
Concentrate
Pressure tube with
membrane
Permeat Flow
Connection
Raw water
connection
Turn on key
Pressure Switch
Inlet
Service Point

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6 Installation
The installation must be conducted by the manufacturer or by personnel trained
and authorized by the manufacturer.
6.1 Environmental Condition
Conditions for the osmosis room:
 Relative air moisture < 90% at 20°C
 Room temperature between +10°C and +35°C (frost proof)
 Equipped with floor drain, water supply and electrical supply
6.2 Assembly
 Bring the device into the appropriate position
 Adjust machine feet until the device stands level and secure on the floor.
Do not store easily flammable materials in the vicinity of the device.
Do not store chemicals in the vicinity of the device.
Only operate the device with the necessary water pre-treatment.
Room of osmosis may not be freely accessible. (Access for instructed personnel
only)

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6.3 Electrical installation
The installation may only be performed by a qualified electrician.
The device must be supplied by a permanent connection, connectors are not
valid. The disconnection via the main switch at the control cabinet. The power
cord must be provided with a strain relief.
Connection cable RO Medical
For protection against a re-start of the unit, the main switch
can be locked with a padlock.
Safety class I The device is equipped with a Protective earth terminal for
prevention against high touch current
For prevention of the hazard of an electric shock, this device
may only be connected to a power supply with protective
earth.
The power cord is fixed to the device and cannot be replaced.

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6.4 Prefiltration (Example)
Install the necessary water pre-treatment equipment first!
Only then connect the RO medical and start up
Local water works regulations and DIN EN 1717 must be followed.
The water pre-treatment must be adapted to the local potable water quality.

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6.5 Commissioning
Caution, device damage!
The device must be preconnected by a suitable pre-
filter and a softening system
as well as a pressure reducer.
Permeat Flow Connection (2)
Hose nozzle d20
Raw water connection (1)
1“ Internal thread
Drain water
connection (4)
HT 40
Permeat back flow (3)
Hose nozzle d20

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6.6 Initial commissioning
1. Connect and check the raw water connection (1),
permeate flow (2), permeate back flow (3) and waste
water (4)
2. Open the inlet valve manually. To do this, turn the white
magnet coil 45° counter clockwise.
Now water is running into
the device
.
3. Carefully open the screw for the pump venting until a
water outlet can be seen.
Then close the screw again and
reset the solenoid.
4. Make sure that the wall-mounted taps at the start and end
of the ring are open.
5.
6.
Start the device using the toggle switch.
Check all connections for leaks.
7.
8.
Open the three-way valve permeate to the drain.
Allow the device to discard permeate for at least 30
minutes.