nephro SAFE Operating Manual sw ver 2.07 Nov 2015

0044 We hereby declare that the unit described below is in conformity with the Council Directive 93/42/EEC on Medical Devices.

This operating manual applies to models from the product line:

nephro SAFE in the configurations 01NPSAFE1 (500 litres, 400 V, 50-60 Hz), 01NPSAFE1C (500 litres, 400 V, 60 Hz), 01NPSAFE05 (500 litres, without ultrafiltration, 400 V, 50-60 Hz)

with software version 2.07 and higher.

Device no.: SN _____________________________

This operating manual is included in the scope of delivery. It must be kept at hand and be passed on with the unit if it is resold. We reserve the right to make modifications with respect to the specifications and illustrations given in this operating manual that result from technical advancements. This manual, or parts thereof, may not be reprinted, translated or reproduced in any form without written consent of DWA GmbH & Co. KG. This operating manual is not covered by a revision service. Last update: 2015-11, the date of the current edition can be obtained from:

DWA GmbH & Co. KG Großer Sand 8 76698 Ubstadt-Weiher Germany Tel: Fax:

+49 (0) 7251 6900-20 +49 (0) 7251 6900-115

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

Preliminary remarks ...5

2 General information ...6 2.1 Applied directives, laws, standards ...6 2.2 Intended use ...6 2.3 Obligations of the plant operator ...6 2.4 Qualification of the operating personnel ...7 2.5 Packaging and shipping ...7 2.6 Scope of supply...7 2.7 Spare parts ...8 2.8 Disposal ...8 2.9 Supplementary documentation ...8 2.10 Optional accessories ...8 2.10.1 Water Protector ...8 2.10.2 Water Guard...8 2.10.3 Remote control ...8 2.10.4 Modem upgrade kit ...8 3 3.1 3.2 3.3 3.4 3.5 3.6 3.7

Safety instructions ...9 Overall hazard assessment ...9 General safety information ...9 Danger through hot surfaces ...9 Hazards caused by electrical energy ...9 Emissions ...9 Electromagnetic compatibility ...10 Safety devices ...11

4 4.1

Labelling ...12 Symbols on the nameplate and their significance ...13

5 Specifications ...14 5.1 Technical Data ...14 5.2 Flow charts ...15 5.2.1 nephro SAFE with ultrafiltration ...15 5.2.2 nephro SAFE without ultrafiltration ...16 5.3 Functional description ...17 5.3.1 Operation within a system network ...18 6

Installation ...19

7 7.1 7.2

Start-up ...19 Initial start-up ...19 Starting the unit after initial start-up ...19

8 Operation ...20 8.1 Control panel ...20 8.1.1 Key functions...21 9 Operating modes ...22 9.1 STANDBY ...22 9.2 DIALYSIS ...22 9.3 RINSE ...23 9.4 HEAT DISINFECTION ...24 9.4.1 Aborting heat disinfection ...26 9.5 ERROR ...27

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10 Information retrieval and data input ...28 10.1 INFO menu ...29 10.1.1 Info screen: SYSTEMS ...29 10.1.2 Info screen: PRESSURE ...29 10.1.3 Info screen: TEMPERATURE ...30 10.1.4 Info screen: DIGITAL INPUTS ...31 10.1.5 Info screen: DIGITAL OUTPUTS ...32 10.1.6 Info screen: SYSTEM INTERFACE ...33 10.1.7 Info screen: STATISTICS ...34 10.1.8 Info screen: ALARM LIST ...35 10.2 SERVICE menu ...35 10.2.1 Service function: SERIAL COM. OFF ...36 10.2.2 Service dialogue: ACCESS LEVEL ...36 10.2.3 Service function: MAX. TEMPERATURE ...36 10.2.4 Service function: HEATDISINF. ...36 11 Maintenance and servicing ...37 11.1 Inspection intervals ...37 11.2 External cleaning ...37 11.3 Replacing the UF module...37 12 Faults and messages ...38 12.1 Critical faults with unit shutdown ...38 12.1.1 Switching action in the event of Water Guard alarm...40 12.2 Faults without unit shutdown ...41 12.3 Messages ...43 13 Emergency operation...45 13.1 Failure of electrical components ...45 13.2 Leakages ...45 Inventory...46

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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.

Hazard warning: Caution, hot surfaces! Risk of scalding!

1

Preliminary remarks

The heat disinfection unit nephro SAFE is a sophisticated, reliable, state-of-the-art product that has been engineered to meet current safety requirements. This operating manual provides all users with instructions necessary for 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, respect the given instructions and make sure this manual is always at hand at 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 60601-1-2 Medical Electrical Equipment – part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests



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



DIN EN 61010-2-010 Safety requirements for electrical equipment, for measurement, control and laboratory use – part 2-010: Particular requirements for laboratory equipment for the heating of material

2.2

Intended use

The nephro SAFE heat disinfection unit may exclusively be used to heat dialysis water and for heat disinfection of ring mains. 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 any case! 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.

2.3

Obligations of the plant operator

Pursuant to the Operational Safety Regulations and the Ordinance about Installation, Operation and Application of Medical Products, the operator is responsible for the following: 

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 accomplishment of safety-relevant repeat examinations by trained and qualified technical staff (called maintenance personnel in the following).

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2.4

Qualification of the operating personnel

The operating personnel, usually nursing staff, must be initiated to 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 maintenance personnel shall take place during start-up of the installation and when required. Other training is not necessary to operate the unit.

Maintenance personnel is trained exclusively by DWA and receives, upon termination of the training, a certificate entitling them to start-up, maintain, and repair the unit as well as to check the electrical safety.

2.5

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: max. 1900 x 1100 x 2250 (L x W x H) mm, weight: 650 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!

2.6

Scope of supply

The scope of supply of the nephro SAFE heat disinfection unit comprises 

the complete unit according to the order

and following parts: No. Quantity

Unit

Item no.

1

1

units

SO8BNSAFD

Operating manual nephro SAFE in English

2

2

units

ZG05PTFE1

Ring main connection hose, reinforced

3

1

units

SO8C03065

Wastewater hose, hot water resistant

4

5

m

ZG05AL007

Hose OD 10x1.5 (ID 7 mm)

5

1

units

SO8B98063

Connection box, customer interface, duplex

6

4

units

ZG04FD006

Dowel 6 mm

7

4

units

ZG04V8445

Chipboard screw 4x45

8

3

m

ZG13PEK19

Cable 7x0.34

9

15

units

ZG13AE005

End sleeve insul. 0.5 mm 2

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Designation

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2.7

Spare parts

The spare parts list is available to maintenance personnel in the Service manual nephro SAFE. The use of third-party spare parts may impair the intended use of the unit and must thus be checked and approved by DWA.

2.8

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.

2.9

Supplementary documentation

Detailed information about installation, start-up, maintenance and repair is available to maintenance personnel for the nephro SAFE heat disinfection unit in the Service manual nephro SAFE.

2.10

Optional accessories

2.10.1

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.

2.10.2

Water Guard

The Water Guard is a leakage sensor in the osmosis room. It may be mounted at the pretreatment unit's inlet (pressure switch, backflow preventer, filters, softener, etc.) in order to isolate these components from the water supply in case of water leakage.

2.10.3

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.

2.10.4

Modem upgrade kit

The nephro SAFE unit has two serial ports for data logging and remote maintenance. The ports are located at the right side of the control cabinet.

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

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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!



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



Immediately report defective hoses or connections to the maintenance personnel!

3.3

Danger through hot surfaces During heat disinfection, the permeate is heated to up to 90 °C. Unit parts such as valves and connection hoses may get very hot! Wear protective clothing when working on the unit.

The tank is insulated and thus presents no danger of burns. The warning light on top of the control cabinet starts to flash as soon as, during heat disinfection, the permeate temperature in the ring main has exceeded 50 °C.

3.4

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

3.5

Emissions

The unit does not produce any dust or vibrations. The measured noise level is below 65 dB (A). Personal noise protection measures are thus unnecessary.

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3.6

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 separately in the Service manual nephro SAFE.

The nephro SAFE heat disinfection 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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3.7

Safety devices

Safe handling of the unit is provided by the following safety devices mounted at the unit:

(1) Warning light that flashes as soon as the ring main temperature exceeds 50 °C (hot surfaces) (2) Micro fuses in the control cabinet (3) Two redundant heating contactors (4) Pressure sensor for level monitoring and dry run prevention device (5) Temperature limiter protecting against overheat (6), (12), (13) Non-return valves (7), (10) Pressure sensors monitoring the pressure at the ring main inlet and outlet (8) Overflow protecting against back pressure from the drain (9), (11) Temperature sensors monitoring the temperature at the ring main inlet and outlet

1 2

13

3

12

4

11 10 9

5 7

8 6

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4

Labelling The nameplate of the heat disinfection unit 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 NEPSAF #### yy: Year of manufacture 20yy NEPSAF: Device identification ####: consecutive number The version label states the permissible mains voltage, mains frequency and the rated current consumption of the device:

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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

nephro SAFE Performance data

Water connections

Electrical data

Electrical safety

Designation

Specification

Dimensions (L x W x H)

1450 x 790 x 1950 mm

Weight (dry / operation)

max. 450 / 1000 kg

Tank capacity

max. 480 litres

Heat disinfection temperature

> 80 °C

Heat loss at a tank filling temperature of 60 °C

150 W

Nominal pump pressure

5 bar (regulated)

Supply side (coming from the reverse osmosis unit) Return side (going to the reverse osmosis unit)

Hose ND20 or DIN 32676 (50.5)

Supply side (going to the ring main) Return side (coming from the ring main)

Hose ND20 or DIN 32676 (50.5)

Mains plug

32 A

Supply voltage

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

Power consumption pump

2 kW

Power consumption heating rods

12 kW

Fuse

25 A / Fi ΔI 30 mA

Protection category against electrical shock

1

Overvoltage category

II

Degree of pollution

2

Level of protection against the penetration of IP X4 liquids Feed water

Quality

Dialysis water

Temperature range

5 to 30 °C

Ambient conditions

- Shipping / storage - Operation

+1 to +45 °C +1 to +40 °C

On-site requirements

Drain max. 50 cm above floor level

HT50 pipe, for 6 m3/h, by gravity

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RO 3

RO 2

NRV1, NRV2 NRV3, NRV4 MDV (V4) V1 V2 V5 PV1, PV2 ES

P5, P6, P7 T3, T4, T5

PU1 M1 FR1, FR2, FR3 HZ1 TK1

Legend

Spring loaded non return valves Non return valves Motorised rotary valve Control pressure valve Filling valve Drain valve Sampling valves Point of use (ring main)

Pressure sensors Temperature sensors

Booster pump UF module Throttles Heater Tank

p=0

Conc.

p(Perm)

Return

Feed

T3

P7

nephro SAFE

HZ1

FR1

V1

NRV4

NRV1

NRV5

V2

MDV

TK1

Tank

DR1

PV1

V4

M

FR3

NRV2

FR2 V3

V6

p=p(Perm)

V5

T4

T5

PU1

UF module M1

NRV3

P6

P5

PV2

Ring main feed

p=P5(Set)

Ring main return

5.2.1

Ring main

5.2 Flow charts

nephro SAFE with ultrafiltration

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RO 1

HKBAE-6 Operating manual nephro SAFE.doc

Booster pump UF module Throttles Heater Tank

Pressure sensors Temperature sensors

Spring loaded non return valves Non return valves Motorised rotarz valve Control pressure valve Filling valve Drain valve Sampling valves Point of use (ring main)

P5, P6, P7 T3, T4, T5

NRV1, NRV2 NRV3, NRV4 MDV (V4) V1 V2 V5 PV1, PV2 ES

RO

PU1 M1 FR1, FR2, FR3 HZ1 TK1

Legend

p=0

Conc.

p(Perm)

Return

Feed

P7

nephro SAFE

HZ1 T3

FR1

V1

FR2

NRV4

NRV1

NRV5

V2

MDV

TK1

Tank

DR1

PV1

V4

M

NRV2

p=p(Perm)

V5

T4

NRV3

P6

PU1

T5

P5

PV2

Ring main return

Ring main feed

Ring main 1

Ring main 2

5.2.2 nephro SAFE without ultrafiltration

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5.3

Functional description

In DIALYSIS operating mode, dialysis water is provided by the upstream reverse osmosis unit and conveyed by the nephro SAFE unit via the circulation pump PU1 through the connected ring main(s). If the nephro SAFE unit is equipped with an M1 ultrafiltration module the circulating permeate is filtered continuously. The heat disinfection unit can be configured such that the TK1 tank is filled with excess permeate during dialysis via the V2 filling valve, or that the filling process starts autonomously before the HEAT DISINFECTION operating mode starts. During HEAT DISINFECTION mode, hot permeate is conveyed from the tank via the open V4 motorised rotary valve through the connected ring main(s). The orientation of the V1 control valve and the upstream reverse osmosis unit being inactive cause a minimum pressure at the ring main outlet and thus a relatively high pressure difference compared to the ring main inlet. This causes the ring main to be flushed with relatively high flow rates. Connected dialysis machines and feed hoses can be included in the heat disinfection process during the CIRCULATION phase. The nephro SAFE unit is equipped with various energy saving configuration options. It is, for example, possible to select whether the returning permeate is reheated during dialysis or during heat disinfection, or whether only the volume really needed is filled, heated at the beginning of the heat disinfection, in order to avoid peak loads. When in RINSE mode, the nephro SAFE unit can turn on the upstream reverse osmosis unit(s) at programmable intervals in order to minimise the risk of biological contamination during idle times.

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5.3.1

Operation within a system network

As explained above, the nephro SAFE unit has the role of a master device within a DWA system network. This means that it activates upstream reverse osmosis units if required. Within a standard DWA system network, automatic dialysis and rinse as well as automatic restart after power failure must be disabled in the upstream reverse osmosis units. The following system network combinations are possible: Parameter

Description

RO SLAVE

The nephro SAFE unit controls the reverse osmosis unit, i.e. it starts and stops dialysis and rinse modes.

RO MASTER

The reverse osmosis unit starts and stops dialysis.

NO RO

The reverse osmosis unit is not able to emit a status signal.

RO1 - RO2

The nephro SAFE unit controls two reverse osmosis units in alternating operation.

RO1 + RO2

The nephro SAFE unit controls two reverse osmosis units in simultaneous parallel operation.

RO1+2-RO3

The nephro SAFE unit controls three reverse osmosis units in alternating operation: two RO units are active while one remains in STANDBY.

RO1+2+3

The nephro SAFE unit controls three reverse osmosis units in parallel operation.

RO1 -> RO2

The nephro SAFE unit controls two reverse osmosis units in simultaneous series operation (two stages).

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6

Installation The unit is installed by DWA technicians or maintenance personnel. Basic installation instructions can be found in the Service manual nephro SAFE.

7 7.1

Start-up Initial start-up The heat disinfection unit is commissioned and approved by DWA technicians or maintenance personnel. The start-up instructions can be found in the Service manual nephro SAFE.

7.2

Starting the unit after initial start-up After the power switch has been pressed, the unit carries out a self-test. The power switch is located at front of the control cabinet.

Self test screen display System test OK

Initialisation fault display System test not OK

If the self-test is OK, the unit switches to STANDBY mode after approx. 5 sec.

In case of PSU fault: check fuses (maintenance personnel), restart the unit!

Date and time of the last unit power off are displayed in addition.

For other faults: restart the unit!

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8

Operation For standard operations, the unit is operated in the modes   

STANDBY, DIALYSIS and HEAT DISINFECTION

If a fault occurs or if servicing and maintenance work are required, there are further operating modes available.

The unit is generally operated via the front panel. Additionally, the unit can be operated via an optional remote control or via the terminal interface.

8.1

Control panel

The control panel is a back-lit LCD with a keypad. It displays the context-dependent meaning of the keys, the unit status, and the relevant operating data of the unit.

LCD

Example: STANDBY

Status display, screen name

Key 1: Messages list Key 2: Info screens

Screen content

Key 3: Service menu Key 4: Start dialysis

Message (only for pending messages)

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Current time

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