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Summary of Contents for Nipro RO Medical
- Page 1 Instruction for use RO Systems | Variant: RO Medical February 10, 2022 Version: 3 Written by: NIPRO Pure Water Document ID: MM 4037 RO-MED-IFU-1001 LNG: EN...
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Page 2: Table Of Contents
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 2/50 Table of Contents 1 General ....................6 1.1 Water quality ..................6 1.2 Scope of supply ..................6 1.3 Unit combinations ................... 6 1.4 Accessories and Consumable ..............7 1.4.1... - Page 3 February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 3/50 5.2 Operations sequence ................16 5.3 Components ..................17 6 Installation ....................18 6.1 Environmental Conditions ............... 18 6.2 Assembly ....................18 6.3 Electrical installation ................19 6.4 Pre-filtration (Example) ................
- Page 4 February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 4/50...
- Page 5 February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 5/50 For the reverse osmosis type RO Medical, conformity is declared in accordance with REGULATION (EU) 2017/745 ANNEX IX 0297 CHAPTER I, III AND SECTION 4 Foreword This instruction for use includes all information required for the installation and operation of the reverse osmosis model RO Medical.
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Page 6: General
1.2 Scope of supply The scope of delivery includes the following parts: 1 reverse osmosis 1 connection set 1.3 Unit combinations The unit model RO Medical Basic may be combined with the following devices: Permeate Tank City Water Tank... -
Page 7: Accessories And Consumable
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 7/50 1.4 Accessories and Consumable 1.4.1 Accessories Distribution loop/permeate loop Must conform to ISO 23500-1:2019 and ISO 23500-2:2019 1.4.2 Consumables RO-Membrane item reference: SP-872 1.5 Notes for the Operator... -
Page 8: Product Label
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 8/50 Product label UDI Number Consult instruction for use Medical Device Serial number CE mark with the number of the notified body. Here, DQS Protection against the ingress IPX 4 of liquids. -
Page 9: Shutdown
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 9/50 1.11 Shutdown If a unit is shut down for more than 5 days, preservation will be necessary. Please contact NIPRO Pure Water before preservation. 1.12 Disposal According to the WEEE guidelines of the European Union, the disposal of electronic devices and electronic sub-assemblies and parts into the general garbage is unlawful. -
Page 10: Intended Operation
Page 10/50 2 Intended operation The RO Medical is a water purification system that uses reverse osmosis to remove microbiological, organic, and inorganic contaminants from the tap water. The purified water is used to dilute dialysis concentrate to form dialysate for dialysis machines used in hemodialysis therapies. -
Page 11: Intended Users
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 11/50 Intended users The end-users of the devices must be trained staff of the dialysis center including: Dialysis center technicians Nursing staff Physicians The use is reserved for highly qualified professional users. An introduction/training must be given to the user. -
Page 12: Safety
Page 12/50 3 Safety Risk Assessment There will be no dangers associated with the reverse osmosis model RO Medical Basic if the operating instructions are followed. The device can automatically start by way of an auto-start. The device was developed and tested in accordance with current standards. Nevertheless, influence through electromagnetic fields cannot be completely excluded. -
Page 13: Technical Data
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 13/50 4 Technical Data Permeate performance / Feed quantity Temperature 1 Membrane 2 Membranes 3 Membranes 4 Membranes 15° C 350 l/h 700 l/h 1050 l/h 1400 l/h... -
Page 14: Display System
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 14/50 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 Ambient temperature Storage / transport 1-40°C Operation 10-35°C... -
Page 15: Description Of The Device
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 15/50 5 Description of the device Flow Chart 1. Magnetic valve inlet 9. Temperature sensor 2. Pressure switch input 10. Conductivity probe permeate flow 3. Disinfection point 11. -
Page 16: Operations Sequence
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). -
Page 17: Components
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 17/50 Components Pressure tube with Display membrane Turn on key Pressure switch inlet Permeate flow Main switch connection Pressure switch inlet Emergency Service point mode switch Flow display... -
Page 18: Installation
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 18/50 6 Installation The installation must be conducted by the manufacturer or by personnel trained and authorized by the manufacturer. Environmental Conditions Conditions for the osmosis room: Relative air moisture <... -
Page 19: Electrical Installation
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 19/50 Electrical installation The installation may be performed only by a qualified electrician. The device must be supplied by a permanent connection, connectors are not valid. The disconnection must be via the main switch at the control cabinet. The power cord must be provided with a strain relief. -
Page 20: Pre-Filtration (Example)
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 20/50 Pre-filtration (Example) Install the necessary water pre-treatment equipment first! Connect the RO Medical after that, and start up. Local water works regulations and DIN EN 1717 must be followed. -
Page 21: Commissioning
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 21/50 Commissioning Caution, device damage! The device must be preconnected by a suitable pre-filter and a softening system as well as a pressure reducer. For first commissioning, disinfection is required. -
Page 22: Initial Installation
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 22/50 Initial installation Connect and check the raw water connection (1), permeate flow (2), permeate back flow (3), and waste water (4). Open the inlet valve manually. To do this, turn the white magnet coil 45°... -
Page 23: Operation
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 23/50 7 Operation Control Panel Display (3) Toggle switch (1) Right side main switch (5) Fault light (2) Emergency operation switch 1. Toggle switch system on 4. Key switch emergency operation... -
Page 24: System On / Off Without Permeate Tank
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 24/50 System on / off without permeate tank System on To start the device, turn the toggle switch to the right (on position). The green lamp lights up. -
Page 25: Device On / Off With Permeate Tank
Page 25/50 Device on / off with permeate tank If the RO Medical is connected to a permeate tank, the toggle switch must be set to "Auto". Since the device switches off automatically when the tank is full, it is not necessary to reset it to position 0. -
Page 26: Emergency Operation
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 26/50 Emergency operation Caution! If the HC Medical hot cleaning system is connected, the following steps must be carried out before emergency operation: 1. Check HC Medical for pending alarms. -
Page 27: Operating Display
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 27/50 Operating display System Off Device is off. Set: 90:00 Rinsing interval (target) is set to 90 minutes. Actual: 25:22 25:22 min have already passed. Until rinsing If the actual value reaches the set point, the system goes into rinsing. -
Page 28: Malfunction
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 28/50 8 Malfunction The device discerns between notifications and alarms. Notifications are simply for information; the appropriate measures will be started automatically. Alarms on the other hand will always result in the device shutting down. -
Page 29: Maintenance And Cleaning
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 29/50 9 Maintenance and cleaning External Cleaning A slightly damp, lint-free cloth can be used to remove dirt stains and dust from pipes and other surfaces. Do not clean the device with solvents. -
Page 30: Maintenance Intervals
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 30/50 Maintenance Intervals No service or maintenance work may be carried out during treatment. Measure Period Notes Responsible Fill salt at softener Daily User Chemical disinfection If needed and once per... -
Page 31: Chemical Disinfection
Chemical Disinfection A chemical disinfection should only be performed upon a new installation or when high pathogen values are encountered. Disinfection may only be performed by NIPRO Pure Water or by instructed persons. Caution when handling disinfectants! Peracetic acids can cause damage to your health. Always read the safety instructions before handling. -
Page 32: Microbiological Inspection
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 32/50 Microbiological Inspection Necessary Values (According to ISO 23500) Pathogens < 100 CFU/ml no traces of Pseud. aeruginosa and E. coli Endotoxins < 0.25 EU/ml Inspection Interval Inspection of permeate every 3 months. -
Page 33: Display / Parameter
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 33/50 Display / Parameter 10.1 Retrieval of the operating hours / conductivity records Press the F1 key. The operating hours are displayed. If the key is pressed again, the display changes back to the standard display. -
Page 34: Change The Conductivity Parameter
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 34/50 10.2 Change the conductivity parameter Press the F4 key and F2 key simultaneously. The conductivity in the return is displayed. Press the ESC key for 3 seconds, the first value is marked. -
Page 35: Change Parameter Temperature
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 35/50 10.3 Change parameter temperature Press the F4 key and F3 key simultaneously. MAX1 = The temperature is displayed. MAX2 = Press the ESC key for 3 seconds, the first value is marked. -
Page 36: Technical Appendix
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 36/50 Technical Appendix The settings and functions described in the following may be performed only by technically trained personnel. No service or maintenance work may be carried out during treatment. -
Page 37: Replacement Of The Reverse Osmosis Membrane
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 37/50 Replacement of the reverse osmosis membrane Beware of pressure! Membrane tubes are under pressure. Open carefully! Visual check of damage new membrane before installation is required. Preservation solution must be clear. -
Page 38: Service Parameters
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 38/50 Service Parameters The settings and functions described below may be carried out only by technically trained personnel. ATTENTION, SYSTEM DAMAGE! Incorrect settings can lead to damage. -
Page 39: Adjustment Of The Conductivity
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 39/50 12.1 Adjustment of the conductivity - Select parameter Conductivity - "Ax" value = displays conductivity - Select value "B" and confirm with Enter - Change the value with the arrow keys (+00001 = current value +1) - Page 40 February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 40/50...
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Page 41: Auto Start (Timer)
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 41/50 12.4 Auto Start (Timer) Select service mode Logo settings < ENTER > Program < ENTER > Set parameters < ENTER > Select parameter B040<ENTER> To exit, press ESC 5x and ▲ arrow key up To set the on-/off- times: - Move the cursor to one of the parameters of the timer. -
Page 42: Service Point
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 42/50 12.5 Service point The service point can be used for water withdrawal to check water temperature and conductivity. Service point may only be opened, if operating pressure in the system is reached. -
Page 43: Disinfection
Instruction for use RO Systems | Variant: RO Medical Page 43/50 Disinfection Disinfection may be performed only by NIPRO Pure Water or by instructed persons. Caution when handling disinfectants! Peracetic acids can cause damage to your health. Always read safety instructions before handling. - Page 44 February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 44/50 Connect the disinfection pump to the disinfection point. Open the three-way valve permeate to the drain. Start the device. Start the disinfectant pump. Check for correct disinfectant concentration at the permeate outlet with test strips.
- Page 45 February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 45/50 Let the system run until no more disinfectant can be detected at the permeate drain. Use Minncare residual test strips for this. Close the three-way valve permeate to the drain.
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Page 46: Disinfection Protocol
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 46/50 13.1 Disinfection Protocol Dialysis center Section Contact person Function Street / Bldg. No. Postcode / City Unit model : RO Medical Serial number: Ring line length... -
Page 47: Emc Manufacturer's Declaration
February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 47/50 EMC manufacturer’s Declaration Electromagnetic emissions and electromagnetic immunity The RO device is intended for use in electromagnetic environments as described below. The customer or the operator of the RO should ensure that the device is only used in such an environment. - Page 48 February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 48/50 Test level – IEC Compliance Electromagnetic Immunity test 60601 level environment - Guidelines Discharge of ± 6 kV contact ± 6 kV contact The floor should be made of...
- Page 49 February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 49/50 nominal output of the respective transmitter specified by the manufacturer in Watts (W), and d is the recommended safety distance in meters (m). The field strength of...
- Page 50 February 10, 2022 Instruction for use RO Systems | Variant: RO Medical Page 50/50 Recommended minimum distances between portable and mobile RF communication devices and the RO The RO is intended for use in electromagnetic environments in which radiated RF disturbances are controlled.
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