0004334 OWA OPERATING INSTRUCTIONS SINGLE-USER REVERSE OSMOSIS SYSTEM HemoRO 3000 DWA cmbii & Co. KG GroRer Sand 8 76698 Ubstadt-Weiher ermany Tel: +49 (0) 72.51 / 6900-20 ee ee eal ert I: m I: line.cor Internet: www.dwa-online.comDWA CE 0044 Conformity with the Council Directive 93/42/EEC concerning medical devices is declared for the device described here. ‘These operating instructions apply to devices of the product series: HemoRO 3000 from software version L20 Serial number: These operating instructions are part of the scope of supply. They must be kept ready close at hand and also remain with the device in the event of resale. We reserve the right to make changes in relation to the data and figures published in these operating instructions, due to further technical development. Reprints, translations and reproductions in any form whatsoever, including in extracts, require the written approval of DWA GmbH & Co. KG. ‘These operating instructions are not subject to an alteration service. Status of the operating instructions: 2016-06, you can find out the current status at DWA GmbH & Co. KG GroRer Sand 8 76698 Ubstadt: Weiher Germany Tel: +49 (0) 7251/69 00-20 Fax: +49 (0) 72 51/ 6900-115, This is a translation of the original operating instructions, HABA1E-17 operating instructions HemoRO 3000 2182DWA Explanation of the symbols used 1 Preliminary comment. 2 General information .. 21 Applied directives and standards. 2.2 Definitions of terms.... 23 Purpose. 24 Intended use... 25 Obligations of the operator. 2.6 Qualification of the operating personnel 2.7 Packaging and transport... 2.8 Scope of supply. 2.9 Supplementary documentation 2.10 Spare parts. 2.11 Disposal 212 Optional accessories. 2421 Water Guard... 2122 Optional pre-stage 2123 Trolley 2.13 Consumables! 3 Safety advice 3.1 Overall danger assessmert....... 344 Dangers in home dialysis environments . 3.2 General safety instructions rome 3.3 Danger due to electrical eneray. 34 Emissions. 3.5 Electromagnetic compatibility z ‘| - est 35.1 EMC sources in the environment of US... 14 36 Safety features... lc 15 4 Labelling. 41 Type plate 4.2 Symbols of the type plate. —— seer 43 Further markings 7 5 Specifications. 5.1 Technical data, Sad Variants... eee erences 51.2 Possible combinations 19 51.3 Hard water operation «1... sonnets 19 5.2 Quality and conductivity of the dialysis water een nee 20) 5.3 Microbiology. 20 5.4 Flowchart, COHN ie tS ita eae aaa | 5.5 Functional description... eee eaeereeee ate 22 56 Device views 23 56.1 Delivery condition: 024RO3000, 02HRO3002 23 56.2 Operating mode: 02HRO3000, 02HRO3002 enna 56.3 Delivery condition: 02HRO3110, 02HRO3111 25 56.4 Operational state: 02HRO3110, O2HROS111 cen 0 26 6 Installation f 61 Requirements for the installation room, 27 62 __ Installation conditions. 28 HABA1E-17 operating instructions HemeRO 3000 31527 Commissioning 74 Switching on. 72 Switching the device Off ....-.cnmmmnnnnnnnnnnnnnnnninnsnnnnnnnnnnnannnesses 8 — Operation .. 5 81 Control panel 30 82 Display texts..... Pe eel 824 Top line .... eae oe 4 822 Bottom line . 32 823 Key functions... hill g i tiet ite 2) 83 Switching operating modes. ae 33 9 Operating modes. 9.1 STANDBY..... 92 DIALYSIS. 93 RINSING ccccsermeainioni 36 934 Overview: Rinse cycles. 37 9.4 DECALCIFICATION. se eee Le, ce 944 Decaleification prompt. 38 942 Conditions 39 94.3 Working St898 .nnnnnnnunnnnnnnn 40 95 CHEMICAL DISINFECTION 4 95.4 Handling and safety instructions... ss ai 952 Recommended disinfectants and compositio 42 953 Amount of disinfectant ee 954 Conditions 955 Working steps 9.56 Releasing the dialysis operation again 96 FAULT. 10 Information request 11 Maintenance and care... 14.1 Inspection intervals 14.2 External cleaning 14.3 Sampling to determine the bacterial COUN cece 49 14.4 Replacing the pre-filter cartridge... 50 12 Faults and messages Inventory. HABAIE-17 operating instructions HemoRO 3000 4152DWA Explanation of the symbols used | Refers to useful information and important advice in the respective factual connection, Refers to @ possibly dangerous situation. If you do not act carefully, property damage could result Refers to a dangerous situation. If you do not avoid these, personal damage, including very severe injuries, may be the result! ‘Symbol for separate collection of electrical and electronic devices and bri circulation after 13th August 2005. y Denotes a minimum and maximum temperature limit. —= [REF] Symbol for "reference/item number’ A Warning of dangerous electrical voltage! Observe the expiry date! 1. Preliminary comment ‘These operating instructions are intended to serve all users as a basis for action for the safe and danger- free use of the device. The operating instructions contain important information for the operation and care of the device and concerning how to proceed in the event of malfunctions. Read the operating instructions, follow the stated instructions and always keep the operating instructions. close to hand (1) Beet tw operating Vaotractionm bora ynioerry ott notion an tha abel HABATE-17 operating instructions HemoRO 3000 5/52DWA 2 General information 2.1 Applied directives and standards * Council Directive 93/42/EEC of 14 June 1993 concerning medical devices + IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance * IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - requirements and tests 2.2 Definitions of terms Permeate Water with @ reduced proportion of contents, which is obtained by pre- treatment and reverse osmosis. Dialysis water Treated water that meets the requirements of ISO 13959 and is suitable for applications in haemodialysis and related therapies (Source: ISO 23500). Concentrate Water with an increased proportion of ingredients that is held back by the membrane in the reverse osmosis process. RO means “reverse osmosis system”, In this application, permeate is used as dialysis water. In the document, the term “permeate” [7] relates mainly to technical aspects of the process, “dialysis water” generally denotes the end- product for the treatment. 2.3 Purpose The single-user reverse osmosis system HemoRO 3000 produces dialysis water and supplies it to a connected dialysis machine through a hose line that fulfils the function of a dialysis water main. [7] Dialysis water is obtained through the membrane separation process "reverse osmosis” HABA1E-17 operating instuctons HemeRO 3000 6/82DWA 2.4 Intended use The single-user reverse osmosis system HemoRO 3000 may exclusively be used to produce and distribute dialysis water. Other applications, in particular the use of media other than those specified in the technical data may lead to hazardous situations and must absolutely be refrained from! ‘Any deviating use shall be considered to be contrary to intended use. Operating the device in the event of defective safety features and the incorrect installation, commissioning, operation and repair of the device shall also be considered to be contrary to intended use. DWA GmbH & Co. KG shall not be liable for any resulting damage. Changes in performance of the device and the use of non-original spare parts shall require the review and approval of DWA. [i] The compliance with the prescribed operating and maintenance instructions shall also be part of the intended use. 2.5 Obligations of the operator ‘The operator is in general responsible for the selection of the components of the water preparation system and water distribution system, = the compatibilty of the individual components with each other, = adherence to the safety regulations and the taking of precautions for work safety and accident prevention, = the intended use of the device by instructed operating personnel, = the instructing of operating personnel, = the managing of an inventory, = the carrying out of the technical inspections, in adherence to deadiines, by trained skilled personnel (called maintenance personnel in the following) and + the carrying out of appropriate tests to ensure compliance with the requirements, as soon as changes were made to the system. HABATE-17 oporating instructions HemoRO 3000 7182_DWA 2.6 Qualification of the operating personnel Operating personnel must receive instruction in the operation of the device and the special features of operation. Only instructed persons of legal age may use the device! Instruction by the manufacturer or maintenance personnel takes place during commissioning and when required. Further training is not necessary for the operation of the device. Maintenance personnel is exclusively trained by DWA and receives, after successful [1] completion of raining, acerticate valid for two years which authorises ils bearer to carry out the commissioning, maintenance, repair and inspection of the electrical safety of the device. 2.7 Packaging and transport Follow the accident prevention regulations and handling instructions on the packaging! A Attention: Do not throw; do not put weight on! * Packing size: 800 mm x 520 mm x 460 mm (W x H x D) + Weight of the packaged device: max. 35 kg Protect from frost and heat! Storage and transport from +1 °C to +45 °C Attention: If condensation occurs during transport between two places with different temperatures and high humidity, the device must be dry before it can be turned on! The drying time must be at least 36 hours at 25 °C. HABA1E-17 operating instructions HemoRO 3000 3/52DWA 2.8 Scope of supply The scope of supply includes a complete HemoRO 3000 device as ordered, incl. operating instructions and the following parts: Item | Quantity | Unit Item no. Name. 1 1 Pack |20KSET110 _|Sampiing set 2 1 Pack |S08808490 __|[Decalcification set 3 1 Pack |S08B09816 [Castor set 4 1 Piece _|S08B27003__|Feed water connection 3/4” IT 5 1 Piece _|S08B70013 _|Dialysis water hose line 6 1 Piece [08008443 [Pipe bracket for concentrate discard 7 2) Metre [ZG05SI021__| Silicone hose 14x3 white (ON8) 8 2) Metre |ZG05SI016 _| Silicone hose 14x3 black (ON6) 9 6 Piece [ZG05V9416 [Ear clamp 16.5 10°) 1 Pack |CDPR00605 _ | Filter cartridge F20 25 um 1") 1 Piece |S08B08452A _|Pre-filter unit F20 12°) 1 Piece |¥¥0000003 [Spanner for filter housing F20 )2HRO3002 HABA1E-17 operating instructions HemoRO 3000 9182DWA 2.9 Supplementary documentation For the setting up, commissioning, maintenance and repair of the single-user reverse osmosis system HemoRO 3000, detailed information is available to the maintenance personnel in the service manual HemoRO 3000, 2.10 Spare parts ‘The spare parts list is available to the maintenance personnel in the service manual HemoRO 3000. Attention: The use of non-original spare parts can impair the intended use and must be checked and approved by DWA! 2.11 Disposal Due to the implementation of the EC directive of 2002/96 on waste electrical and electronic a equipment (WEEE directive), it is no longer permitted to dispose of waste electrical devices or electronic or electrical assemblies as household waste. mmm These parts must be disposed of in an environmentally friendly way! If nothing different has been agreed with DWA and a private disposal system is not available, DWA devices and their possibly environmentally hazerdous components can be returned to DWA. HABAE-17 operating instructions HemoRO 3000 10/82DWA 2.12 Optional accessories 2.12.1 Water Guard ‘The Water Guard by DWA acts as a leakage detector. It can be installed at the start of the water supply, in order to separate downstream components from the water supply in the event of a leak. [i] OWA recommends to install a Water Guard or an external leckage monitoring on site. 212.2 Optional pre-stage The optional pre-stage for HemoRO 3000 devices has an activated carbon cartridge of 10° and two fine filter of 10° with pore sizes of 20 and 5 microns for the protection against unwanted water components. 2423 Trolley The optional trolley allows safe and convenient moving of the HemoRO 3000. The trolley also has a storage facility for the hoses of the single-user reverse osmosis system. For further information on optional accessories please speak to your responsible DWA field representative. 2.13 Consumables! . $08B08490: _Decalcification set ~ contains 8x 100 ml citric acid of 50 % . 20KSET110: Sampling set ~ contains 6 sampling bags and accessories . CDPROOGOS: HABA1E-17 operating instructions HemoRO 3000 an/s2DWA 3 Safety advice 3.1. Overall danger assessment The device has been constructed according to the state of the art and meets the requirements of the Medical Device Directive and the harmonised standards for medical devices. When used according to regulations, the device does not cause any danger. AX Attention: Errors that impair the intended use must be recti 1d without delay! 344 Dangers in home dialysis environments © Ent Danger for children by strangulation, parts in home dialysis environments! ting, electrical power and detachable small iron or pets unattended near the device! 3.2. General safety instructions + Never by-pass or override safely features! Never cover the device or parts of the device! = Donot place any combustible objects close to or on the device! "In the event of leaks, unusual noises or smells, separate the device from the power supply, observe the device and inform the maintenance personnel! + Report damaged lines or connections immediately to the maintenance personnel! You can turn off the single-user reverse osmosis system HemoRO 3000 immediately in all operating modes without any risk by interrupting the power supply, see Section 7.2 "Switching the device of J & HABA1E-17 operating instructions HemoRO 3000 12/52DWA 3.3. Danger due to electrical energy Warning of dangerous electrical voltage! ‘The housing of the device may be opened only by maintenance personnel for maintenance or repair purposes! [7] A recurrent test of electrical safety must be carried out annually as part of a technical inspection! 3.4 Emissions The emission sound pressure level, measured under laboratory conditions, is below 80 dB(A) in full- load operation. Hearing protection measures are therefore not necessary. [7] Dust formation and vibration do not occur with the single-user reverse osmosis system HemoRO 3000. 3.5 Electromagnetic compatibility Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in the ‘accompanying documents. ‘The provision of EMC information according to EN 60601-1-2:2007 section 5.2.2 takes place in the service manual HemoRO 3000. Attention: The single-user reverse osmosis system HemoRO 3000 is tested and protected according to the requirements and recommendations of EN 60601-1-2:2007 (Electromagnetic compatibility - Requirements and tests). Despite this, influencing by other devices cannot be ruled out. Portable and mobile radio frequency communications equipment can affect medical electrical equipment. A HABATE-17 operating instructions HemoRO 2000 13/52AN Attention: system HemoRO 3000. Mobile phones and other wireless devices can affect the single-user reverse osmosis EMC sources in the environment of use Keep the following safety distances to the single-user reverse osmosis system when using mobile phones and other wireless devices. Device ‘Max. transmission power Safety distance [Mobile phone (GSM/ UMTS) 2.00 W 3.30.m [Mobile phone (DECT) 0.25 W 1.15 m WLAN devices 0.10 W 075m HABAIE-17 operating instructions HemoRO 2000 The values given refer to German law. 14782DWA 3.6 Safety features ") 2) = Microfuses (part of the control board) = Audible warning device (part of the control board) = Conductivity measurement for monitoring product quality (in connection block) 1°) Pressure reducer 2°) Pre-fiter unit *) apples only to 0214203000 and [REF] a2H1RO2002 HABA1E-17 operating instructions HemoRO 3000 15/524 Labelling 4.1 Type plate =] Wasserzulaut Feed water Indlab Intopp | Permeat: Riicklauf Permeate: Return Permeat: Returlab \ \ | Permeat: Returlopp Permeat: Voriauf Permeate: Feed Permeat: Indlob | Permeat: Inlopp Abfluss, | Drain ce HamoRO 3000 HemoRO 3000 || Einzelplatz-Umkehrosmoseantage |__Single user reverse osmosis unit | ) SN] | xx HRO3000 #8 REF]| 02HRO3 yyy CE 0044 © D4 — tai] DWA cmt 8 co. ke GroBer Sand 8 76698 Ubstact Weiher Deutschland / Germany HABAIE-17 operating instructions HemoRO 3000 DWA Connection label ‘Inlet’ Hose colour: white Connection label "Dialysis Water Return’, hose colour: blue Connection label "Dialysis Water Feed’, hose colour: black Connection label “Drain’, hose colour: black ‘The version label (A) shows the permissible mains voltage, mains frequency and the rated ‘current consumption of the device: 230 V / 50-60 Hz/ 3.5 A/IPX4 or 115 V/.60 Hz/ 7 AJ IPX4 The serial number manufacture, device identification and consecutive number: Example: xx HRO3000 #44 20c Year of manufacture 20xx HRO3000: Device identification ‘#i#H: consecutive number The code [REF] represents the item number of the device. 16152IPK4 4.3 @ DWA The type plate of the single-user reverse osmosis system is located on the right side of the housing, Symbols of the type plate ‘Symbol for "serial number ‘Symbol for "reference/item number". ‘Statement of the protection type, in this case: protection against splashed water from all sides, ‘Symbol for “conformity with the Directive 93/42/EEC" concerning medical products. The following number identifies the notified body, in this case: 0044. Mandatory sign “Follow operating instructions”. Consequences of non-compliance: Possibly incorrect operation of the device! Precautions to minimise risk: Follow the operations 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. Further markings Prohibition sign “Pushing forbidden” ‘Consequences of non-compliance: The device can tip over! Precautions to minimise risk: Do not push the device. HABA1E-17 operating instuctons HemoRO 3000 srs25 Specifications 5.1 Technical data DWA ‘HemoRO 2000 Parameter Value Dimensions Measurements (Wx Hx D) 480 x 170 x 360 mm Weight Dry weight 25 kg Operating weight max. 35 kg) Performance data Dialysis water capacity 50 Uh "24, 70 Uh 9) Jat 10 °C and 2.5 bar counter pressure Dialysis water pressure 3 bar/0.3 MPa Retention rate > 95 % NaCl Water connections Feed water Hose stem D8 Dialysis water Nipple type 103 DNG Waste water Hose stem D8 Electrical data Mains plug CEE 7/7234 NEMA 5-15P Mains voltage 230 V AC 50-60 Hz®>) 415. V AC 60 Hz 49) Building fuses 46 A, RCD in = 30 mA Power consumption 300 W Protection class H Protection type IPX4 Feed water Quality Drinking water, not permeate ®) Hardness, see Section 5.1.3 < 25 °dH/ 4.45 mmovl 24) < 15 °dH 12.45 mmol 39) Blocking index / SDI <3 Conductivity < 2,000 uS/em tron <0.05 molt Free chlorine <0.1 ml Temperature range 5t0 30°C pH 6.51085 [Waste water Free flow max. 100 cm above device top edge Environmental conditions | Transport / storage temperature 110 45°C (Operating temperature 110 35°C Air humidity max. 90 % RAH, non- condensing Installation altitude ‘max. 2,000 m above NHN” applies to soft water food 2 applies to [REF] 0241802000 appies © using permeate as feed waters forbidden “I NHN: German reference "Normathahennul* (standard elevation 2er0) HABAE-17 operating instructions HemoRO 3000 18/52814 Variants ‘The single-user reverse osmosis system HemoRO 3000 is available for two mains voltages: + [REF]02HR03000 and [REF] 02HRO3002: 230 V AC, 50-60 Hz + [REF]02HRO3110 and [REF] 02HRO3111: 115 V AC, 60 Hz 5A2 Possible combinations The single-user reverse osmosis system HemoRO 3000 can be operated with a connected dialysis machine. Heat disinfection systems - not applicable Dialysis water ring mains = not applicable 51.3 Hard water operation {]__ The single-user reverse osmosis system HemoRO 3000 can be operated with hard water up to 15 °dH (2.45 mmolf) or up to 25 °dH (4.45 mmolf), see Section 5.1 "Technical data’. Attenti DWA recommends using soft water as feed water! A reduced dialysis water capacity must be expected when using hard water feed. Due to necessary decalcification, a shorter membrane life is foreseeable when using hard water feed! The device is factory-set to soft water feed (0 “dH / 0 mmol). Maintenance personnel can modify the set feed water hardness if necessary. ‘The set feed water hardness determines the frequency of decalcification prompts, see | Section 9.4 "DECALCIFICATION’. HABA1E-17 operating instructions HemoRO 3000 19/52DWA 5.2 Quality and conductivity of the dialysis water The quality of dialysis water is decisively influenced by the chemical composition of the feed water and the microbiological state and/or care of the single-user reverse osmosis system. _, _ Although reverse osmosis membranes hold back almost all undesirable parts of the feed i] _ water, a few ions may pass through the membrane, influencing the conductivity of the dialysis water. = The conductivity of the feed water limits the reachable conductivity of the produced dialysis water! Carry out regular chemical analyses of the feed and dialysis water in order to be able to detect changes and take suitable measures. 5.3. Microbiology Dialysis water is subject to limit values for microbiological contamination. With new installations, these can generally be adhered to without any problem. Germs are almost entirely held back by the reverse ‘osmosis membrane. In addition, germ grow is reduced to a minimum by automatic flushing while the device is in an idle state. In the total system, there also exists, however, the possibility of retrograde contamination, e.g. via the removal point at the treatment place, so that bacteria are detectable in the dialysis water. Carry out germ and endotoxin tests regularly and take suitable disinfection measures if there is contamination. On this subject, refer also to Section 11.3 "Sampling to determine the bacterial count". Avoid long periods of idleness for the system, in order to minimise germ growth, HABAIE-17 operating instuctons HemoRO 3000 20/52DWA 5.4 Flow chart bd On «0 O 0 ——— Feed water (btue) Permeate (green) Concentrate (red) Dialysis water hose (green, dashed) 00 Feed water connection 0 Dialysis water connection (feed) 01") Pressure reducer 10 Extraction point for dialysis water 02 ‘Solenoid valve for food water " Dialysis water connection (return) 03 Conductivity sensor for feed water 2 Pressure sustaining valve (permeate) Tank 1a/ 14a Restictor (concentrate discard) 0s, Injection port 13b/ 14» Restictor (concentrate recirculation) Pump 15 Motor cooing jacket (pump) o7 Reverse osmosis madule 18 Waste water connection os ‘Conductivity sensor for dialysis water }02103000 and [REF] 0211803002 HABA1E-17 operating instructions HemoRO 3000 2isseOWA 5.5 Functional description The single-user reverse osmosis system HemoRO 3000 produces dialysis water and pumps it through a connected hose line to supply dialysis water to a dialysis machine for haemodialysis at the treatment centre. The feed water flows through (the supplied fine filter, pressure reducer, *) the inlet solenoid valve and the input conductivity sensor to the tank. From there, the feed water is conveyed with the pump to the reverse osmosis membrane. At the reverse osmosis membrane, the water flow spiits into = concentrate and dialysis water. The restrictors in the concentrate outlets of the pressure vessel maintain the module pressure. One part of the concentrate flows back into the tank for saving water, the other part flows over the motor cooling jacket to the drain, The dialysis water flows through the dialysis water hose and can be removed at the extraction point. The pressure sustaining valve secures the extraction pressure. The conductivity of the dialysis water is measured continuously in the dialysis water flow. Excess dialysis water is recirculated to the tank. (02HR03000 and REF] 02HRO3002 +) applies only to HABATE-17 operating instructions HemoRO 3000 22152DWA 5.6 Device views 5.61 Delivery condition: 02HRO3000, 02HRO3002 4 Control panel 6 Dialysis water connection (feed) 2. Injection port 7 Dialysis water connection (return) 3 Type plate *) 8 Feed water connection 4 Prefer 9° Pressure reducer 5 Waste water connection 40. Strain relief of mains cable *) not shown HAGA1E-17 operating instructions HemoRO 3000 2352DWA 5.6.2 Operating mode: 02HRO3000, 02HRO3002 Please note the illustrated hose guiding and the assignment of hose colours. ‘The hose lengths illustrated do not match the delivery and target state! = 1. Pipe bracket for concentrate discharge 4 Extraction point for dialysis water 2 Waste water hose (black) 5 Feed water hose (white) 3. Dialysis water hose (blue) 6 Feed water connection 3/4" IT HABA1E-17 operating instructions HemeRO 3000 24152DWA Delivery condition: 02HRO3110, 02HRO3111 1 Control panel 5 Dialysis water connection (feed) 2 Injection port 6 Dialysis water connection (return) 3. Type plate *) 7 Feed water connection 4 Waste water connection 8 Mains cable ‘)not shown HABAIE-17 operating instructions HemeRO 3000 251/52DWA 5.6.4 Operational state: 02HRO3110, 02HRO3111 [[]__ Please note the illustrated hose guiding and the assignment of hose colours. The hose lengths illustrated do not match the delivery and target state! 6 1 Pipe bracket for concentrate discharge 4 Feed water connection 3/4" IT 2 Waste water hose (black) 5 Extraction point for dialysis water 3. Feed water hose (white) 6 Dialysis water hose (blue) HABATE-17 operating instructions HemoRO 3000 26/52DWA 6 Installation =| The single-user reverse osmosis system is installed by DWA technicians or maintenance personnel. The procedure is described in the service manual HemoRO 3000. 6.1 Requirements for the installation room * Switchable permanent installation (applies to home dialysis environment) "Mains socket: CEE 7/4 '2) or CEE 7/5 '2) or NEMA 5-1P ®! (applies to professional healthcare facility) "Mains voltage: 230 V, 50-60 Hz") or 116 V, 60 Hz 23) = Fusing: 16 A, RCD lay = 30 mA * Lockable water connection: 3/4” AG. + The room should be ventilated; the maximum relative air humidity must not exceed 90 %. "The room must be no higher than 2000 m above NHN") °) MHI: German reference "Normalhchennul” (standard elevation zero)" (0214803000 and [REF] 02HRO3002 024R03110 o2HRo3T11 DWA recommends to install a Water Guard or an external leckage monitoring on site. Caution: In home dialysis environments, the switchable permanent to the device, easily identifiable and accessible! AX Attention: To prevent the risk of electric shock, this device may only be connected to a supply mains with a protective earth conductor by qualified personnel! {\ Attention: The integrity of the protective earth conductor-protection measure and the protective conductor connection of the device must be verified at permanently installed devices! HABA1E-17 operating instructions HemoRO 3000 27152DWA 6.2 Installation conditions The single-user reverse osmosis system must be installed tilt-proof on level ground! The single-user reverse osmosis system must always be accessible. In particular, the switchable permanent installation / the mains plug and the device control pane! must always be accessible! ‘The surroundings of the single-user reverse osmosis system and escape routes must always be kept clear! AX Attention: The single-user reverse osmosis system must not be exposed to direct sunlight! AX Attention: The single-user reverse osmosis system HemoRO 3000 must not be placed in direct patient environment! HABA1E-17 operating instructions HemoRO 3000 28152DWA 7 Commissioning we The single-user reverse osmosis system is commissioned and released by DWA technicians or maintenance personnel. The procedure is described in the service manual HemoRO 3000, Switching on The HemoRO 3000 has no main switch. The single-user reverse osmosis system is ready for operation as soon as voltage is applied. Switching the device off You can turn off the single-user reverse osmosis system HemoRO 3000 immediately in all operating modes without any risk by interrupting the power supply. Home dialysis environment ‘Tum the switch of the switchable permanent installation to the OFF position, Professional healthcare facility Disconnect the mains plug from the mains socket 8 Operation Generally, operating personnel use the single-user reverse osmosis system HemoRO 3000 in the operating modes ‘STANDBY DIALYSIS, DECALCIFICATION DISINFECTION The device is operated using the control panel in the housing cover. HABA1E-17 operating instructions HemoRO 3000 29/52DWA 8.1 Control panel The control panel of the single-user reverse osmosis system has a backlit liquid crystal display with an integrated keypad. Display field HemoRO 3000 DYWA Koy Koy2 The two-line display field shows the current operating mode in the top line; the bottom line shows the device function that can be started. Display field STANDBY Operating mode (see Section 8.2.1) Device function that can be started (see Section 8.2.2) HABATE-17 operating Instructions HemoRO 2000 30/52DWA 8.2 824 Display texts Top line The top line of the display field shows the current operating mode of the device or the current programme step and possibly pending errors or messaces. Operating mode _|Display Explanation [STANDBY ‘The device is in standby for dialysis operation. ‘STANDBY [STANDBY -Decalcify! [Decalcification prompt. (ow ‘The device isin the dialysis operation, (ON -Decalcity! Decalcity after dialysis operation has ended ON -cD > #FR us! Message dependent on limit value at increased dialysis water conductivity. [Default setting: 50 uS/cm. DIALYSIS oN -CcD > WFR pS! ‘Shut-off dependent on limit value at increased dialysis water conductivity. Default setting: 100 uSicm. Range: 20 -240 uSiem. low Water supply is critical. ‘This message appears as soon as the lower level [contact in the tank has been reached. RINSING [STANDBY -RINSING.- [Automatic rinsing has started. DECALC. ~inject! Prompt to fill citric acid. DEC =flush in Flushing in citric acid DECALC. —take effect [Action phase. DECALG. —flush out DECALCIFI- Rinsing out citric acid. CATION DECALCIFY complete Decalcification has been completed properly. DECALG. -dry runt [Water supply is critical ‘This message appears as soon as the lower level [contact in the tank has been reached and the inlet solenoid valve is open, Tinject! Prompt to fil disinfectant. =flush in Flushing in disinfectant. ‘take effect [Action phase. flush out Rinsing out disinfectant. DISINFECTION ished Disinfection has been completed properly. Water supply is critical ‘This message appears as soon as the lower level contact in the tank has been reached and the inlet solenoid valve is open. HABAE-17 operating instructions HemoRO 3000 31/52DWA Operating mode | Display Explanation SR FATBURS [The power supply was interrupted. FAULT: ORY RON [The water supply is interrupted. CD MAX The device has been shut down due to increased FAULT dialysis water conductivity. FAULT: PUMP |The pump is not working properly. FAULT: SYSTEM [A programme error has occurred FAULT: DECALE/DISINE [No eitrie acid or disinfectant was detected during decalcification respectively disinfection. Further information on errors and messages, refer to Section 12 “Faults and messages’ Bottom line Press the key SELECT in the bottom line of the display field shows the device functions one 4) after the other, The device function can be activated with the key CONFIRMATION Display Explanation Select: On ‘Switches the device to operating mode DIALYSIS. Select: Off Switches the device to operating mode STANDBY. Select: Decalcify [Switches the device to operating mode DECALCIFICATION. Disinfection | Switches the device to operating mode DISINFECTION Test Displays the operating values in the bottom line of the display field, see Section 10 “Information request’ Select: Acknowledge [Acknowledges a pending error. 8.2.3 Key functions SELECT - to scroll through screen contents or functions (_f]| CONFIRMATION - to trigger a function (acknowledge, save, exit, etc.) HABA1E-17 operating instructions HemoRO 3000 32/52DWA 83 Switching operating modes You can switch the operating mode by selecting the desired system function with the key SELECT in the bottom line of display field: then you can perform the selected function with the key CONFIRMATION. Start decalcification Suree eerie i a Start disinfection select vistarention| mae HABAIE-17 operating instructions HemoRO 3000 93/52eo DWA 9 Operating modes 9.1 STANDBY The device is in operating mode STANDBY as soon as voltage is supplied. The single-user reverse osmosis system is not productive in this state; however, control electronics and timers are running, HemoRO 3000 TANDBY Press the key CONFIRMATION (3 sec.) 10 stat the production of cialysis water HABATE-17 operating insiuctons HemoRO 3000 34152DWA 9.2. DIALYSIS [i] inthis operating mode, the single-user reverse osmosis system produces dialysis water. FemoRO 3000 ON Press the key CONFIRMATION (3 sec.) 10 stop the production of dialysis water HABA1E-17 operating instructions HemoRO 2000 35529.3. RINSING FZ) The rinsing operation minimises the settling of germs in the single-user reverse osmosis LU system during idle periods. HemoRO 3000 ANDBY NS ts OFF The operating mode RINSING is started from the operating mode STANDBY by stored limit values. Eunctional description: ‘When the single-user reverse osmosis system is idle in operating mode STANDBY for the duration of the set waiting time, the control electronics will start the rinsing operation, In the operating mode RINSING, dialysis water is produced and conveyed through the dialysis water hose, After expiry of the rinsing time, the single-user reverse osmosis system changes automatically back to operating mode STANDBY, ‘The rinsing operation can be interrupted any time with the key CONFIRMATION, AX Attenti Unattended water flow! To avoid water damage, install a water detector that signals an alarm in case of leakage and interrupt the water supply. HABA1E-17 operating instructions HemoRO 3000 36/52DWA 9.3.4 Level ‘Standstill waiting period Rinse time oO Ohours ‘O minutes 1 1 hour 40 minutes: 2 2 hours 15 minutes: a 4 hours 4 6 hours 30 minutes: 5 12 hours: Level 0is set upon delivery, no automatic rinsing. DWA recommends regular standstil rinses (level 2 or 3), however, for maintaining a high microbiological dialysis water quality. Maintenance personnel can change the set rinse cycle if necessary. HABATE-17 operating instructions HemoRO 3000 37182DWA 9.4 DECALCIFICATION [i] _ Inhard water operation, the HemoRO 2000 must be decalcified regulary. The frequency of decalcification prompts depends on the feed water hardness according to the table below. Level Hardness ['dH] Hardness [mmolll] 0 0 0.00- 0.01 : 1 1-5 (0.02 - 0.90 90h 2 6-10 0.91 1.79 75h 3 1-15 1.80 - 2.68 60h 4 16-20 2.69 — 3.57 45h 5 21-25 3.58 — 4.46 25h “) n= operating hours of DIALYSIS Level 0 requires soft water operation and disables decalcification prompts. On delivery, level § is set. Your maintenance personnel will adapt the required hardness level to the local conditions during commissioning, When changing the water hardness level, the remaining time until the next decalcification prompt is considered and recalculated 9.44 Decalcification prompt The decalcification prompt appears when needed: Operating mode: STANDBY Operating mode: DIALYSIS STANDBY -Decalcify! Select: On ON -Decalcify! Select: Off The dialysis operation does not have to be interrupted! HABATE-17 operating instructions HemoRO 3000 38/52: _DWA 9.4.2 Conditions Decalcification takes about 40 minutes. For this period, the HemoRO 3000 is blocked and no dialysis ‘operation can take place! Attention: No extraction may take place during decalcification! Before starting decalcification, disconnect the dialysis mac! port for dialysis water of the reverse osmosis unit. 1e from the extraction AX Attention: The single-user reverse osmo: Follow t system is decalcified with 100 ml citric acid of 50 %. handling and safety instructions for citric acid of 50%. For decalcifying the single-user reverse osmosis system, use the convenient DWA decalcification set S08B08490 (contains 5x 100 mi citric acid of 50%). HABA1E-17 operating instructions HemoRO 3900 39/52DWA 9.4.3 Working steps 1. After the decalcification prompt is displayed, press the key SELECT in operating mode STANDBY until the following display appears: STANDBY -Decalcify! Select: Decalcify 2. Press the key CONFIRMATION for 4 seconds until the following display appears: DECALC. -inject! Select: - 3. Fill 100 ml citric acid of 60 % in the tank through the injection port. The following display appears automatically after about 1 minute: DECALC. -flush in Select: - + Pump active, after 30 seconds: DECALC. -take effect Select: - ¥ Pump inactive, after 15 minutes: DECALC. -flush out Select: - ¥ Pump active, after 20 minutes: DECALCIFY complete Select Decalcification successful or FAULT: DECALC/DISINF Select: Acknowledge Decalcification not successful Decalcification successful = citric acid was detected. Decalcification not successful = citric acid was not detected. HABAIE-17 operating instructions HemoRO 3000 40/52DWA 9.5 CHEMICAL DISINFECTION DWA recommends chemical disinfection of the single-user reverse osmosis system HemoRO 3000 = atincreased bacterial counts, after work on the hydraulic system = oratter an idle period of 72 hours. Check the bacterial contamination regularly by sampling, see Sections 5.3 “Microbiology and 11.3 “Sampling to determine the bacterial count”! A hygiene plan implemented by the operator has priority! ’ 2 Chemical disinfection must always be carried out under responsibility of the operator! @ ba ee Disinfectants represent a health hazard to users and patients! 95.1 Handling and safety instructions Warning of caustic or iritant substances: & & Disinfectants may chemically burn skin and mucous membranes or damage clothing eo @ Use protective goggles and gloves when working with disinfectants. Disinfectants support combustion. Maintain good ventilation of the room and avoid sources of ignition. @ Eating and drinking are prohibited when handling disinfectants. HABA1E-17 operating instructions HemoRO 3000 401529.5.2 ectants containing chlorine may be used for chemical disinfection of the single-user reverse osmosis system HemoRO 3000! The disinfectants listed below are a mixture of acetic acid, peracetic acid, hydrogen peroxide and water. The balance of the disinfectant is sensitive and the effective concentrations may vary, particularly when containers are already open. Note the expiry date! DWA recommends using the following, approved disinfectants: Puristeril 340 by Fresenius Medical Care AG & Co. KGaA ‘Component Concentration [%] [Acetic acid 1-<10 Perace 3-<5 [Hydrogen peroxide | -25-<30 RB, R 22, R34, S 3I7, S 14.2, S 26, S 36/37/39, $45 Puristeril plus by Fresenius Medical Care AG & Co. KGaA Component Concentration [%] Acetic acid 3-4 Peraceti Hydrogen peroxide 1314, P260, P280, P303+P361+P353, P305+P351+P388, P314, P501 Dialox by Bioxal SA ‘Component Concentration [%] [Acetic acid <10 Hydrogen peroxide 5-8 R38, R 41, $ 26, $39 HABAE-17 operating inetructons HemoRO 3000, 42/82Hazard warnings as specified by the manufacture R8 Fire hazard on contact with flammable substances. R22 Harmful if swallowed R34 Causes chemical burns. 314 Causes severe chemical burns to skin and severe eye damage. R38 Irritating to the skin. R41 Risk of serious damage to eyes Sar Store in 2 cool place and keep container tightly closed. S142 Keep away from alkalis. S26 In case of contact with eyes, rinse with water and seek medical advice. $ 36/97/39 Wear suitable protective clothing, gloves and eye / face protection while working, $45 In case of accident or if you feel unwell, seek medical advice immediately (produce label if possible). 839 Wear eye / face protection 260 Do not inhale vapour / aerosol. P2860 Wear protective gloves / eye protection. P303+P361+P353_On contact with skin (or hair): Take off all solled or soaked clothing immediately. Rinse skin with water or shower. P305+P351+P338 On contact with the eyes: Rinse carefully with water for a few minutes. Remove contact lenses if possible. Continue rinsing, Pata If you feel unwell, seek medical advice / get medical attention. 501 Dispose of contents / container in accordance with local / national regulations. 953 ‘Amount of disinfectant Chemical disinfection of the single-user reverse osmosis system HemoRO 3000 requires + 25 ml Puristeril 340 or 90 mi Puristeril plus or = 90 mi Dialox. HABA1E-17 operating instructions HemoRO 3000 43152DWA 9.5.4 Conditions Chemical disinfection will take about two hours. For this period, the HemoRO 3000 is blocked and no dialysis operation can take place! 95.5 Attentior No extraction may take place during chemical disinfection! Before starting disinfection, disconnect the dialysis machine from the extraction port for dialysis water of the reverse osmosis unit. Working steps Press the key SELECT in operating mode STANDBY until the following display appears: STANDBY Select Fill the required amount of disinfectant DISINF. -flush in Select: DISINF, -take effect Select: DISINF. -flush out Select: finished DECALC/DISIN seconds until the following display appears: (see Section 9.5.3) in the tank through the injection nozzle. The following display appears automatically after about 1 minute Pump active, after 30 seconds: Pump inactive, after 15 minutes: Pump active, after 100 minutes: Disinfection successful Acknowledge HABA1E-17 operating instructions HemoRO 3000 Disinfection unsuccessful 44782[1] _ Disinfection successful = disinfectant was detected, Disinfection not successful = disinfectant was not detected. 9.5.6 Releasing the dialysis operation again o a a ee After a chemical disinfection, it must be checked whether the completely rinsed out! infectant has been For detecting the absence of disinfectant, DWA recommends test strips for 0 - 25 magi! hydrogen peroxide (item no. Z61800050), ‘Switch the single-user reverse osmosis system to operating mode ON and prove the absence of isinfectant at the extraction port for dialysis water by letting the produced permeate flow over atest strip. Only if zero is indicated, absence of disinfectant can be assumed! HABA1E-17 operating instructions HemoRO 3000 45/52DWA 9.6 FAULT The single-user reverse osmosis system changes to operating mode FAULT when an error occurs. HemoRO 3000 FAULT: DRY RI elect: Acknowledge Ae DWA Press the key CONFIRMATION to acknowledge the eror To exit the operating mode FAULT, the error must be corrected and confirmed with key CONFIRMATION. [7] Further information on errors and messages, refer to Section 12 “Faults and messages’. HABA1E-17 operating insbuctons HemeRO 3000 46/5210 Information request allows you to read the operating values of the single-user [i] The function sete: LAI reverse osmosis system Press the key SELECT in each operating mode until Select: Test appears in the bottom line of the control pane: ON Press the key CONFIRMATION Display: feed water conductivity Scroll: Press key SELECT Display: dialysis water conductivity Display: operating hours Display: remaining time DECALCIFICATION (only accessible during ongoing decalcification) Display: remaining time DISINFECTION (only accessible during ongoing disinfection) Display: remaining time RINSING or time to next rinsing (only accessible if rinsing is enabled, see Section 9.3). » The retrieval of operating values can be terminated at any time by pressing the key CONFIRMATION. HABA1E-17 operating instructions HemoRO 3000 47152DWA 11 Maintenance and care 11.1 Inspection intervals Compliance with the maintenance recommendations stated in the following table ensures proper operation of the single-user reverse osmosis system HemoRO 3000, Day | Wee | Monn | 2montie | 6menths | Year | Comment \Vistal inspection x Replace pre-fiter cartridge x [Decalcification Wihen needed, see Section 94 Disinfection Wien needed, ee Section 95 Maintenance x Maw Technical inspection xan | may +) Look out for leaks, unusual noises or odours 2) applies only to [REF] 02RO3000 and[ REF] 02HRO3002 AX Attention: The recurrent test of technical inspection! lectrical safety must be carried out annually as part of a HABAE-17 operating instructions HemoRO 3000 48/5211.2 DWA External cleaning Moisten a soft cloth with water or a common household cleaner and remove the dust and stains. Do not clean device parts with readily volati 11.3 solvents, such as e.g. thinners or petrol! Attention: ‘Surface disinfectants can attack plastics and in particular make them brittle and cracked. Damaging media include, among others, isopropyl and methylene chloride as ingredients of surface disinfectants. Only use surface disinfectants in a targeted and sparing way on the device. Briefly cover surfaces made of plastic that you do not have to disinfect directly during the surface disinfection and wipe off surfaces made of plastic that are made wet by spray mist Using a hygienic cloth, in order to prevent lasting impairments, Even stainless steel tends to rust when it comes into contact with solutions containing high levels of chlorine. Therefore, immediately remove all splashes of brine or salt dust from the device, which could accumulate during the filing of the salt tank of the softener. Sampling to determine the bacterial count In general, the regulations of the European Pharmacopoeia and/or the international standards 1SO 23500 andior ISO 13959 are drawn upon for the quality of the produced dialysis water. These specify the following limit values for the microbiological conditions: Bacterial count: < 100 CFU/ml (CFU = Colony-Forming Units) Endotoxin: < 0.25 IU/ml (IU = International Units) In the case of a system validated according to ISO 23509, it is recommended to carry out a sample at the end of the dialysis water ring main once a year. The actual intervals and number of samples taken are determined by the validation plan of the operator. With the DWA sampling set (Item no.: 20KSET110), you can remove dialysis water at sampling points and send them for laboratory testing; packaging and identification materials are included with the sampling sets. HABATE-17 operating instructions HemoRO 3000 49/52DWA 11.4 Replacing the pre-filter cartridge T] _DWA recommends replacing the pre-fiter cartridge every two months Working step 1. Disconnect the device in operating mode STANDBY from the power supply. 2. Shut off the water supply. 3. Unscrew the filter housing from the filter head. 4, Remove the old pre-fiter cartridge and replace with new one 5. Screw the fiter housing back on the fiter head 6 Open the water supply. 7. Reconnect the device to the power supply. I] _ Dispose of used pre-filter cartridges properly as part of household waste! HABAIE-17 operating instructions HemoRO 3000 50/52DWA 12 Faults and messages | Errors and messages are displayed on the display panel. Error Message "AULT: CD MAX ON -CD > ### pS ! Selec knowledge | Select: Off In case of fault, the device is turned off Dialysis operation is still possible when messages ‘accompanied by an acoustic warning signal. are pending. Fault Description and problem-solving approach The power supply was interrupted. ‘The error appears when the function AUTO-ON is activated and the Power interruption lasts longer than 2 minutes, or immediately if the function AUTO-ON is disabled. Operating personnel: acknowledge er FAU! RON [The water supply is interrupted. ‘The error appears when no inflow has taken place for a period of 15 ing ps ipply. I I |personnel: Check inlet solenoid valve and level sensor in tank. ae The device has been shut down due to increased dialysis water Sel vwtecise_} [eonductivity. |’Maintenance personnel: Check limit value, sensor and other causes if necessary, FAU; Mi [The pump is not working properly ‘Maintenance personnel: Check pump and level sensor in tank if necessary SLT? SYSTE ‘A programme error has occurred. | Operating personnel: Disconnect device briefly from the power supply. If ‘unsuccessful: Maintenance personnel: replace software if necessary. No citric acid or disinfectant was detected during decalcification respectively disinfection, ‘Maintenance personnel: check conductivi ifnecessary HABATE-17 operating instructions HemoRO 3000, 51/52Inventory Internal identification number: Site and internal allocation: Device type and name: DIMDI classification: Expansion stage, number of modules: Serial number: Year of purchase: Manufacturer: Notified body: DWA single-user reverse osmosis system HemoRO 3000 UMDNS code 14-437 Water Purification Systems, Reverse Osmosis DWA GmbH & Co.KG. Grofer Sand 8 76698 Ubstadt-Weiher Germany TUV NORD CERT, Identifier: 0044 MOD class lib, accessory to @ medical device Technical inspection: ‘Once a year Instruction of operating personnel: Date Name Signature HABAIE-17 operating instructions HemoRO 3000 52/52