Nipro PHOENIX ONE DS Manual de usuario

Operator´s Manual

Reverse Osmosis

TYP: PHOENIX ONE DS

Datum: 13.01.2021 |Version: 3

Written by: Nipro Pure Water

 
 
 
Table of Contents 
1 General .............................................................................................. - 2 -
 Shipment ........................................................................................... - 2 -
 Unit combinations ............................................................................... - 2 -
 Accessories and Consumables............................................................... - 2 -
 Notes for the Operator.........................................................................- 2 -
 Laws and Standards ............................................................................- 2 -
 Symbols used in this Manual ................................................................ - 3 -
 Transport and Storage ......................................................................... - 3 -
 Model Plate ........................................................................................ - 4 -
 Warning on the Unit ............................................................................ - 5 -
Shutdown .......................................................................................... - 5 -
Disposal............................................................................................. - 5 -
Further Documentation ........................................................................- 5 -
2Intended operation ................................................................................ - 7 -
3Safety .................................................................................................. - 8 -
 Risk Assessment ................................................................................. - 8 -
 EMC .................................................................................................. - 8 -
 Emissions...........................................................................................- 8 -
4Technical Data....................................................................................... - 8 -
5Description of the unit .......................................................................... - 10 -
 Flow-Chart ............................................................................................11 
 Operation Sequence Permeate Production .................................................12 
 Assembly groups ...................................................................................13 
6Installation ..............................................................................................14 
 Environmental Conditions .......................................................................14 
 Assembly ..............................................................................................14 
Electrical installation .....................................................................................15 
 Installation plan (Example) .....................................................................16 
7Operation ................................................................................................17 
 Control Panel.........................................................................................17 
 Emergency operation..............................................................................18 
 Manual On / Off .....................................................................................19 
 Quick access keys ..................................................................................20 
 Main menu ............................................................................................21 
 Menu Info .............................................................................................22 

 |3 |13.01.2021 |Seite 3 
 
 Menu Notification ...................................................................................23 
 Menu Statistics ......................................................................................24 
 Menu Functions .....................................................................................25 
Set clock...............................................................................................26 
Timer ...................................................................................................27 
8Maintenance and cleaning..........................................................................28 
 External Cleaning...................................................................................28 
 Maintenance Intervals ............................................................................28 
 Primary Filter Replacement .....................................................................29 
 Chemical Disinfection .............................................................................30 
 Microbiological Inspection .......................................................................31 
9Malfunctions.............................................................................................32 
Technical Appendix..........................................................................................34 
10 Fuses ......................................................................................................35 
Labelling ...............................................................................................35 
Micro Fuses in Control Cabinet.................................................................36 
11 Settings...................................................................................................37 
Setting Ring Pressure (Permeate Pressure) ...............................................37 
Setting Concentrate Pressure ..................................................................38 
12 Replacement of the reverseosmosis membrane ............................................39 
13 switch over only „Step 1“  or only „Step 2“ ..................................................40 
Emergency operation only „2. step“..........................................................41 
14 Disinfection..............................................................................................42 
Disinfection Protocol ...............................................................................43 
15 Service/Limits ..........................................................................................45 
16 EMC MANUFACTURER’S DECLARATION ........................................................47 
Electromagnetic emissions and electromagnetic immunity .................................47 
Warning ......................................................................................................48 
Requirements...............................................................................................48 
Recommended minimum distances between portable and mobile HF 
communicationunits and PHOENIX ONE ....................................................51 
 
 

Nipro Pure Water Operator’s Manual Reverse Osmosis Phoenix One DS

- 1 -

Stand 3 as at 13.01.2021

The reverse osmosis model Phoenix One DS has been declared

conform in accordance with EC directives.

Foreword

This Operator’s Manual includes all information required for the installation and operation for

the reverse osmosis model Phoenix One DS.

Please keep this Operator’s Manual readily available and near the unit.

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

Nipro Pure Water GmbH

Werner-von-Siemens-Str.2-6

76646 Bruchsal –Germany

Tel.: 0049 7251-32 19 7810

Fax: 0049 7251-61 89 943

Rev#

Date / Name

Description

28.02.14 / N.Bürkle

First edition

27.07.16 / N.Bürkle

Nipro

08.09.20 / N.Bürkle

EN60601

13.01.21 / R.Tille

60 Hz Version

0297

Nipro Pure Water Operator’s Manual Reverse Osmosis Phoenix One DS

- 2 -

Stand 3 as at 13.01.2021

1 General

Shipment

The following parts are included in the shipment:

▪1 Reverse osmosis

▪1 Connector set

Unit combinations

The unit model Phoenix DS may be combined with the following devices:

▪Hot cleaning system Phoenix One +

▪Hot cleaning system Phoenix One +FH

Accessories and Consumables

▪1 Prefilter 20‘‘ 10 µm

Notes for the Operator

The operator is responsible for:

▪Competent and intended operation

▪Compliance with work safety and accident prevention provisions

▪Competent instruction or operating personnel

Laws and Standards

The following laws and standards are adhered to:

▪Guidelines of the Medical Devices Directive (Council Directive 93/42/EEC)

▪EN 60601

▪DIN EN 1717 protection against pollution of potable water

Nipro Pure Water Operator’s Manual Reverse Osmosis Phoenix One DS

- 3 -

Stand 3 as at 13.01.2021

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.

Transport and Storage

Protect unit against frost and moisture.

Protect against strong jolting and collisions.

Only move unit upright and with an appropriate lift.

Nipro Pure Water Operator’s Manual Reverse Osmosis Phoenix One DS

- 4 -

Stand 3 as at 13.01.2021

Model Plate

Attention! Adhere for the

accompanying documents

CE-Sign with labeled area.

Here DQS

IPX 4

Protection of liquid entry.

Here splash guard

Drinking water protection

according to EN 1717. Here

free outlet

Serial number

Year of construction

manufacturer

pay attention to manual

Nipro Pure Water Operator’s Manual Reverse Osmosis Phoenix One DS

- 5 -

Stand 3 as at 13.01.2021

Warning on the Unit

Caution! Hot surface. Attached to the tank.

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

control cabinet.

Shutdown

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

Please contact Nipro Pure Water before performing conservation.

Disposal

Regarding the WEEE guidelines of the European Union, the disposal of electronic devices

and electronical 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

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.

Further trainings ate not necessary for this device.

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

Circuit diagrams

Spare parts list

Nipro Pure Water Operator’s Manual Reverse Osmosis Phoenix One DS

- 6 -

Stand 3 as at 13.01.2021

Technical manual

There are additional manuals if the system is operated in combination with the hot

cleaning system Phoenix One + or the hot cleaning system Phoenix One +FH.

Duration of usage

The device is designed for a use of 10 years

Nipro Pure Water Operator’s Manual Reverse Osmosis Phoenix One DS

- 7 -

Stand 3 as at 13.01.2021

2Intended operation

The unit is designed for the preparation 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 system

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 system does not produce water for injections.

The device has pressurized parts.

During failure of the temperature sensor, the temperature might increase. (60

°C)

The water treatment system Phoenix One may only be used for permeate

supply of dialysis devices, which have a temperature measurement (permeate

temperature).

The device does not have direct patient contact and no patient application.

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