Transcription
AquaBplusWater Purification SystemInstructions for UseSoftware version: 3.21Edition: 5F-2020Date of issue: 2020-02Part no.: F40015145
Table of contents1Index2Important information32.1How to use the Instructions for Use . 2-12.2Significance of warnings . 2-22.3Significance of notes . 2-22.4Significance of tips. 2-22.5Brief description . 2-32.62.6.12.6.22.6.32.6.42.6.5Intended use . 2-4Scope of application . 2-4Residual risks . 2-4Target group . 2-5Repair, maintenance, transport . 2-5Expected service life. 2-52.72.7.1Duties of the responsible organization . 2-5Further aspects of the responsible organization. 2-62.8Operator responsibility . 2-72.9Disclaimer of liability. 2-72.10Technical documentation . 2-72.112.11.12.11.22.11.3Warnings . 2-8Basic warnings . 2-8Warnings related to hygiene and biology . 2-10Electrical warning . 2-122.12Addresses . 2-13Design3.13.1.13.1.23.1.33.1.4Views . 3-1Complete system. 3-1Interior (front). 3-2Front view / rear view . 3-3Side view . 3-43.23.2.13.2.2Controls and indicators . 3-5User interface and display . 3-5Display / keys . 3-6Fresenius Medical Care AquaBplusIFU-EN-US-MASTER5F-2020iii
4Operation4.14.1.14.1.2System status STANDBY . 4-1Turning the system ON . 4-1Turning the system OFF . 4-14.2Operating modes and display messages / overview. 4-24.3STANDBY mode. 4-34.44.4.14.4.24.4.34.4.44.4.54.4.6SUPPLY mode. 4-4Starting the SUPPLY mode . 4-4Terminating the SUPPLY mode . 4-4Operation using the Navigation keys. 4-5Automatic start of the SUPPLY mode . 4-5T1 test. 4-6Permeate conductivity and temperature monitoring in SUPPLY . 4-74.54.5.14.5.2RINSE mode . 4-8Manually starting the rinse program . 4-8RINSE active . 4-94.64.6.14.6.2EMERGENCY MODE (option) . 4-10General information . 4-10Starting the emergency mode (option) on the AquaBplus . 4-114.74.7.14.7.24.7.34.7.4STATUS – menu. 4-12Menu structures overview. 4-12Opening the Status menu . 4-13STATUS – Messages . 4-14STATUS – Operating data. 4-154.7.4.1 Viewing the operating data . 4-16STATUS – Hygiene . 4-17STATUS – Start / stop . 4-18STATUS – Rinse . 4-19STATUS – System information. 4-20STATUS – Daily report . 8.44.8.54.8.64.8.7SYSTEM – Menu. 4-23Menu structures overview. 4-23SYSTEM – Programming the Start / Stop . 4-25SYSTEM – Programming the Rinse . 4-294.8.3.1 Programmable rinse parameters. 4-29SYSTEM – Setting the Date and time . 4-30SYSTEM – Setting the Language. 4-31SYSTEM – Report . 4-32SYSTEM – Service (only with password) . 4-324.94.9.14.9.24.9.34.9.44.9.5Remote control via WEB browser . 4-33Connecting to the AquaBplus web server . 4-33Overview of Web server view Overview . 4-35Web server view Status . 4-36Web server view Operating data. 4-37Web server view System information. 4-38Alarms5.1ivGeneral notes. 5-1Fresenius Medical CareAquaBplusIFU-EN-US-MASTER5F-2020
675.2Contacting the service department . 5-25.3Messages . 5-35.45.4.15.4.2Alarm description . 5-4Identification of the error code . 5-4Error categories overview. 5-45.4.2.1 Category 01: System and hardware problem. 5-45.4.2.2 Category 02: Procedure . 5-55.4.2.3 Category 03: Start condition not fulfilled. 5-85.4.2.5 Alarms and information messages – AquaBplus B2 (option) . 5-105.4.2.6 Alarms and information messages – AquaBplus HF (option) . 5-13Cleaning, disinfection, preservation6.1Generally applicable rules for cleaning, disinfection and preservation . 6-16.26.2.16.2.26.2.3Precautions . 6-2Patient safety. 6-2Operator safety. 6-3Protection of buildings . 6-46.36.3.1Disinfection . 6-5Disinfecting the system. 6-56.4Preservation. 6-66.56.5.16.5.26.5.36.5.4Surface cleaning and disinfection . 6-7Surface cleaning. 6-7Cleaning the surface. 6-7Surface disinfection . 6-8Disinfecting the surface . 6-8Functional description7.17.1.17.1.27.1.389Description of the procedure . 7-1Functions . 7-1Operating modes . 7-1Flow diagrams . 7-1Consumables, accessories, additional equipment8.1Consumables . 8-18.2Accessories . 8-18.3Additional equipment. 8-2Installation9.1Important information for operational qualification. 9-1Fresenius Medical Care AquaBplusIFU-EN-US-MASTER5F-2020v
9.29.2.19.2.2Operational Qualification . 9-2To be observed before operational qualification. 9-2Electrical installation . 9-29.39.3.1Operational qualification procedure . 9-3General information . 9-39.49.4.19.4.29.4.3Decommissioning / shutdown / operational requalification. 9-4Decommissioning . 9-4Shutdown. 9-4Operational requalification . 9-410 Transport / storage10.1Transport and storage conditions . 10-110.210.2.110.2.210.2.3Transport . 10-2General information . 10-2Inside buildings . 10-2Outside of buildings . 10-210.3Environmental compatibility / disposal . 10-311 Technical Safety Checks and maintenance11.1Important procedural information. 11-111.2Maintenance procedures . 11-112 ecifications AquaBplus . 12-1Dimensions and weight. 12-1System data. 12-2Identification label (system identification) . 12-3Electrical safety. 12-4Electrical supply. 12-512.1.5.1 Electrical connection of the reverse osmosis system . 12-512.1.6 Fuses . 12-512.1.7 Guidance and manufacturer’s declaration for EMC (IEC 60601-1-2:2007) . 12-612.1.7.1 General specifications for IEC 60601-1-2 . 12-612.1.8 Operating conditions. 12-1112.1.9 Transport and storage conditions . 12-1312.1.10 External connection options. 12-1412.1.11 Materials used . 12-14vi12.2Specifications for AquaBplus B2 (option). 12-1512.3Specifications for AquaBplus HF (option) . 12-20Fresenius Medical CareAquaBplusIFU-EN-US-MASTER5F-2020
13 Definitions13.1Terms and definitions . 13-113.2Abbreviations. 13-113.3Icons . 13-213.4Certificates . 13-414 Module and 1.714.1.814.1.914.1.10AquaBplus B2 module (double pass reverse osmosis system) . 14-1Preface . 14-1Contents overview . 14-1Functional description – AquaBplus B2 . 14-2System design – AquaBplus B2 . 14-3Operating modes – AquaBplus B2 . 14-5System status STANDBY – AquaBplus B2 . 14-5SUPPLY mode – AquaBplus B2. 14-5RINSE mode – AquaBplus B2 . 14-6DISINFECTION mode – AquaBplus B2. 14-6EMERGENCY MODE (option) . 14-614.1.10.1General information. 14-614.1.10.2Starting the emergency mode on the AquaBplus B2. 14-714.1.11 STATUS – Information – AquaBplus B2. 14-914.1.12 STATUS – Operating data for AquaBplus B2. 14-914.1.12.1Viewing the operating data. 14-1014.1.13 Specifications – AquaBplus B2. 714.2.814.2.914.2.1014.2.1214.2.1314.2.14Module AquaBplus HF (ring heat disinfection module). 14-12Preface . 14-12Contents overview . 14-12Functional description – AquaBplus HF. 14-13Design – AquaBplus HF. 14-14HEAT DISINFECTION mode – AquaBplus HF . 14-16SUPPLY mode – AquaBplus HF. 14-18RINSE mode – AquaBplus HF. 14-18DISINFECTION mode – AquaBplus HF . 14-18STATUS – Information – AquaBplus HF. 14-19STATUS – AquaBplus AquaBplus HF operating data. 14-1914.2.10.1Viewing the operating data. 14-20STATUS – AquaBplus AquaBplus B2 AquaBplus HF operating data. 14-2114.2.11.1Viewing the operating data. 14-23SYSTEM –Settings. 14-25Menu structures overview – AquaBplus HF. 14-26Specifications – AquaBplus HF. 14-2914.3Other options . 14-3014.2.1115 Appendix15.115.1.1Medical Device Register AquaBplus . 15-1Responsible organization and identification . 15-1Fresenius Medical Care AquaBplusIFU-EN-US-MASTER5F-2020vii
viii15.1.2Contents of the AquaBplus Medical Device Register. 15-315.2AquaBplus training record . 15-515.315.3.115.3.2Operational data acquisition . 15-10Title page - Operational data acquisition . 15-10Manual operational data acquisition report. 15-1215.415.4.115.4.2Quality of dialysis water. 15-13Microbiological quality standards. 15-13Chemical quality standards. 15-1315.515.5.115.5.215.5.3Collecting a sample on the AquaBplus for microbiological analysis. 15-14Preparation . 15-14Accessories / tools. 15-14Collecting a sample on the AquaBplus . 15-1515.615.6.115.6.215.6.3Collecting a sample on the MSC for microbiological analysis. 15-17Preparation . 15-17Accessories / tools. 15-17Collecting a sample on the MSC . 15-1815.715.7.115.7.215.7.3Collecting a sample for chemical analysis. 15-19Preparation . 15-19Accessories / tools. 15-19Collecting a sample for chemical analysis . 15-2015.8Physical background – diffusion / osmosis. 15-21Fresenius Medical CareAquaBplusIFU-EN-US-MASTER5F-2020
Chapter 1: Index1IndexAGAddresses 2-13Alarms 5-1Guidance and manufacturer'sdeclaration on EMC 12-6, 12-22BIBasic warnings 2-8Icons 13-2STATUS – Menu 4-12Status – Start / stop 4-18Identification label 12-3, 12-16,12-21CImportant information 2-1Installation 9-1MCollecting a sample on theAquaBplus 15-14Medical Device RegisterAquaBplus 15-1Consumables / accessories /additional equipment 8-1Controls and indicators 3-5STATUS – System information4-20Storage conditions 10-1SYSTEM – Date and time 4-30SYSTEM – Language 4-31, 4-32SYSTEM – Menu 4-23Intended use 2-4Collecting a sample for chemicalanalysis 15-19Collecting a sample on the MSC15-17STATUS – Operating data 4-15STATUS – Rinse 4-19Brief description 2-3Cleaning, disinfection,preservation 6-1STATUS – Messages 4-14SYSTEM – Rinse 4-29SYSTEM – Service 4-32System data 12-20System status STANDBY 4-1TNTarget group 2-5Note, significance 2-2Technical documentation 2-7OTechnical Safety Checks /maintenance 11-1Operating conditions 12-11, 12-22Tip, significance 2-2Operation 4-1Training record 15-5Operational data acquisition 15-10Transport / storage 10-1Design 3-1Operator responsibility 2-7Diffusion / osmosis 15-21Operator safety 6-3Transport and storage conditions– AquaBplus B2 12-13– AquaBplus HF 12-19DDecommissioning / shutdown /operational requalification 9-4Disclaimer of liability 2-7PTransport conditions 10-1EPatient safety 6-2Electrical warnings 2-12Physical background 15-21WEnvironmental compatibility /disposal 10-3Protection of the system 6-4External connection options 12-14QFWarnings 2-8Warnings related to hygiene andbiology 2-10Quality of dialysis water 15-13Flow diagrams 7-1SFunctional description / definitions7-1, 13-1Service life 2-5Fuses 12-5, 12-17, 12-22Warning, significance 2-2Specifications 12-1– AquaBplus B2 12-15, 12-20STATUS – Daily report 4-22S
AquaBplus Water Purification System Instructions for Use Software version: 3.21 Edition: 5F-2020 Date of issue: 2020-02 Part no.: F40015145
