Related Manuals for Fresenius Medical Care Dialysis Water Distribution Loop
Summary of Contents for Fresenius Medical Care Dialysis Water Distribution Loop
- Page 1 Dialysis Water Distribution Loop Dialysis Concentrate Distribution Loop Instructions for Use Edition: 02A-2023 Date of issue: 2023-08 Part no.: F50015018 0123...
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Page 3: Table Of Contents
Basic warnings ..........................19 2.18.2 Warnings related to hygiene and biology ..................21 2.19 SVHC (REACH) ........................... 22 2.20 Addresses ........................... 23 Structure and views ........................25 Overall view of the distribution systems.................. 25 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 4 Disinfecting the DWDL ....................... 45 6.4.1 Reasons for disinfecting the DWDL....................45 6.4.2 Disinfecting the system......................... 45 Cleaning connectors and connection ports................47 6.5.1 Cleaning the connectors ....................... 47 6.5.2 Cleaning the connection ports ...................... 47 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
- Page 5 Handling of disinfectants ......................64 11 Technical Safety Checks and maintenance ............... 65 11.1 Important information for performing the TSC/MA ..............65 11.2 Maintenance procedures ......................66 11.2.1 Quality assurance and care measures ..................66 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
- Page 6 Medical Device Register for the DWDL and DCDL ..............77 15.1.1 Responsible organization and identification ................. 77 15.1.2 Contents of the Medical Device Register for the DWDL and DCDL..........79 15.2 Training Record .......................... 81 15.3 Quality of dialysis water......................86 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 7: Index
Important information 9 Installation 59 Intended combined use 15 Service life 16 Intended patient population 12 Side effects 13 Intended purpose 12 Specifications 67 Intended purpose and related definitions 12 Surface cleaning 43 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 8 Chapter 1: Index Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 9: Important Information
2021 – Page identification Organization of the To facilitate the use of documents from Fresenius Medical Care, the or- chapters ganization of the chapters has been standardized in all manuals. There may therefore be chapters within this document without any content. -
Page 10: Warnings, Significance
– Damage to the DWDL and DCDL distribution systems. – Specific functions not being executed at all or not being executed correctly Tips, significance Information providing useful tips for easy handling. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 11: Brief Description
The distribution systems are connection units which can be extended by the responsible organization with additional components to form a com- plete supply system. They transport dialysis water via the Dialysis Water Distribution Loop distribution system and dialysis concentrate via the Dialysis Concen- trate Distribution Loop distribution system. -
Page 12: Intended Purpose And Related Definitions
2.6.1 Intended purpose Dialysis Water Distribution Loop (DWDL): Central supply of dialysis water Dialysis Concentrate Distribution Loop (DCDL): Central supply of di- alysis concentrate 2.6.2... -
Page 13: Side Effects
Contraindications may exist in the therapy-related context of hemodialysis: – Hyperkalemia (only with potassium-containing hemodialysis con- centrates) – Hypokalemia (only with potassium-free hemodialysis concentrates) – Uncontrollable blood-clotting disorders Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 14: Residual Risks
The use of chemical agents for cleaning and disinfecting the distribution systems entails the residual risk of chemical residues in the dialysis wa- ter and dialysis concentrate. Patients may be exposed to toxic or pyro- genic substances. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 15: Interaction With Other Systems
To perform the Technical Safety Checks and the maintenance proce- dures, contact the local service support. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 16: Expected Service Life
This measure does not relieve the re- sponsible organization of its obligation to regularly check the inlet water composition. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 17: Operator Responsibility
Within EU Member States, the user must report any severe incidents associated with the product to the manufacturer in accordance with the identification as well as the responsible authority of the Member State in which the user is located. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 18: Disclaimer Of Liability
2.17 Technical documentation Descriptions and other technical documents can be provided by the manufacturer on request. These are intended to support appropriately trained personnel of the responsible organization in maintaining and re- pairing the system. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 19: Warnings
Note Adherence to applicable laws and regulations Observe all applicable local laws and regulations concerning the handling of laboratory equipment and reagents. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 20 Regular visual inspection and leakage checks of all tubing, connec- tors, and piping containing fluid are required. Tubing must be protected against possible mechanical damage. Note The distribution system is not designed for supporting additional loads. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 21: Warnings Related To Hygiene And Biology
Observe the safety precautions for the disinfectant / cleaning agent used, including the relevant first aid measures. Note Risk of infection Observe the applicable local laws and regulations concerning the han- dling of potentially infectious material. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 22: Svhc (Reach)
Chapter 2: Important information 2.19 SVHC (REACH) Information on the subject of SVHC in accordance with Article 33 of Regulation (EC) 1907/2006 ("REACH") is available from the following website: www.freseniusmedicalcare.com/en/svhc Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 23: Addresses
Chapter 2: Important information 2.20 Addresses Manufacturer Fresenius Medical Care AG & Co. KGaA Else-Kröner-Str. 1 61352 Bad Homburg GERMANY Phone: + 49 6172 609-0 www.freseniusmedicalcare.com International service Fresenius Medical Care support Deutschland GmbH Technical Operations Technical Coordination Office (TCO) - Page 24 Chapter 2: Important information Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 25: Structure And Views
Chapter 3: Structure and views Structure and views Overall view of the distribution systems Legend Green Dialysis Concentrate Distribution Loop (DCDL) Blue Dialysis Water Distribution Loop (DWDL) Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 26: Overall View Of Dwdl
Chapter 3: Structure and views Overall view of DWDL DWDL (Example MediaR) Overall view of DCDL DCDL (Example MediaR) Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 27: Operation
Blue: dialysis water connection Gray: drain connections 4.1.2 MediaP Yellow: gas connections Blue: dialysis water connections Gray: drain connections Green: dialysis concentrate connections 4.1.3 MediaR Green: dialysis concentrate connections Blue: dialysis water connection Gray: drain connection Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 28: Observe When Operating
Observe the In- structions for Use for the hemodialysis device. It is absolutely essential to avoid contaminating the connections through contact with skin or other non-sterile objects. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 29: Connecting And Disconnecting
If the lock is not released completely, this can cause increased wear and, as a consequence, fluid leakage. To connect and disconnect the coupling system, push the sleeve of the lock as far as it will go. Recommended equipment – Rubber gloves Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 30 To be observed during disconnecting: Do not place disconnected tubes onto the floor and do not connect with other tubes. Hang the tubes on a suitable support with the opening pointing down. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 31: Microbiological Analysis At The Sampling Port
The following equipment is recommended by the manufacturer: – Rubber gloves – Alcohol-based disinfectant (approx. 70–80 % alcohol, without lipid replenisher) The sampling set for the Fresenius sampling valve (F00010382) can be used for sampling the dialysis water. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 32: Procedure For Collecting A Sample At The Sampling Port
Fig. 2 Fig. 3 Fig. 4 – Opening the sampling valve Turn the sampling valve counterclockwise to open it (Fig. 4). Fig. 4 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 33 Gently squeeze the bag to check for any leaks. Affix the completed label on the bag and place it into the prepared shipping box. The bag must be delivered to the test laboratory within 24 hours. Fig. 8 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 34: Microbiological Analysis At The Dialysis Water Connection
The following equipment is recommended by the manufacturer: – Rubber gloves – Alcohol-based disinfectant (approx. 70–80 % alcohol, without lipid replenisher) – The bag with adapter (6030671) can be used for sampling the dial- ysis water. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 35: Procedure For Collecting A Sample At The Dialysis Water Connection
Affix the completed label on the bag and place it im- mediately into the prepared shipping box. The bag Fig. 5 must be delivered to the test laboratory within 24 hours. Fig. 6 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 36: Collecting A Sample For Chemical Analysis
– Rubber gloves For the chemical sampling, use the sample containers provided by the laboratory. – For the sampling of the dialysis water, the bag with adapter (part no.: 6030671) can be used. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 37: Procedure For Collecting A Sample For Chemical Analysis
When collecting a sample at the coupling on the media Fig. 2 supply column, do not use the bag with adapter as a sample container. Use the bottles supplied by the laboratory as sample containers! Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 38 Chapter 4: Operation Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 39: Alarms
Chapter 5: Alarms Alarms This chapter does not contain any content applicable to this product. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 40 Chapter 5: Alarms Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 41: Cleaning, Disinfection
Wear appropriate personal protective equipment (gloves, goggles, etc.) in line with the safety precautions for the disinfectant / cleaning agent used. Observe the safety precautions for the disinfectant / cleaning agent used, including the relevant first aid measures. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 42 Do not touch the accessible components of the dialysis water distri- bution system while heat disinfection is in progress. Do not attempt to remove the dialysis water manually while heat dis- infection is in progress. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 43: Surface Cleaning, Surface Disinfection
The manufacturer does not assume any liability for potential damage to the surfaces of the DWDL and DCDL if a different disinfectant than the one recommended is used for disinfection. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 44: Surface Disinfectant
The use of ClearSurf (1 % dilution) or ClearSurf Wipes (ready-to-use wipes) is recommended for disinfecting the surfaces. For further information on disinfectants, refer to the chapter on consum- ables (see chapter 8.1 on page 54). Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 45: Disinfecting The Dwdl
Note The system may only be disinfected by trained Clinic Technicians or trained System Technicians who are trained and certified in the appro- priate procedures. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 46 Service Manual of the reverse osmosis systems. Performing heat disinfection The safety precautions and operating steps for heat disinfection are de- scribed in the Service Manual of the reverse osmosis systems. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 47: Cleaning Connectors And Connection Ports
Then use a cloth or swab to pat dry the outer surfaces of the connec- tors. 6.5.2 Cleaning the connection ports Recommended equipment – Rubber gloves – Laboratory spray bottle with dialysis water – Soft, lint-free cloth or swab Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 48: Disinfecting Connectors And Connection Ports
To be observed during disconnecting: Do not place disconnected tubes onto the floor and do not connect with other tubes. Hang the tubes on a suitable support with the opening pointing down. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 49: Disinfecting The Connection Ports
Then wet them with an alcohol-based disinfectant. After the dwell time, dry the outer surfaces of the connection ports with a cloth or swab or allow the disinfectant to evaporate completely. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 50 Chapter 6: Cleaning, disinfection Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 51: Functional Description
The DWDL and DCDL distribution systems are to be regarded as permanently installed units. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 52 Chapter 7: Functional description Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 53: Consumables, Accessories, And Additional Equipment
Upon request the local service support will provide information about further accessories, consumables, and other additional equipment. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 54: Consumables
(or: ClearSurf wipes) Surface disinfectant 6299161 Peracetic acid test 5–50 mg/L 6030671 Bag with adapter Sampling set for standard configuration F00010382 Sampling set for the Fresenius sampling valve Sampling set for dialysis water distribution systems Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 55: Accessories
Contact with dialysis concentrate PPSU; including seal F00010506 Concentrate nipple Contact with dialysis concentrate PVDF; including seal F40005755 Concentrate block K0 Contact with dialysis concentrate MediaR F00010855 Concentrate module Contact with dialysis concentrate MediaR; including nozzles Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 56: Accessories For The Dwdl Distribution System
Stainless steel for PEX tube 25 x 3.5 mm 6325801 PEX connector 180° Contact with dialysis water U-connector for stainless steel cable duct Dialysis water connection, straight Part of the MediaC, MediaP MSM PEX double with connecting element Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 57 Dialysis water module Contact with dialysis water MediaR F00010873 PEX connection, long (set), Contact with dialysis water Dialysis water block MediaR – modular system 6309401 Sleeve No contact with dialysis water 25 x 3.5 mm Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 58: Additional Equipment
Part number Description Information F00010869 Lock washer 17 No contact with dialysis concentrate Dialysis concentrate MediaC, MediaP, with fixing F00010508 Lock washer 17 No contact with dialysis concentrate Dialysis concentrate MediaR, with fixing Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 59: Installation
Leakage sensor The use of a leakage sensor is recommended. Pilot holes The hole pattern with hole sizes and distances must be applied. For fur- ther information, the Installation Guideline (IGL) must be followed. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 60: Operational Qualification
Tester's qualification Operational Qualification must be performed by the technical service department of Fresenius Medical Care or a person authorized by them. The Operational Qualification may only be performed by persons qual- ified to properly perform the specified checks based on their educational background, training, knowledge, and experience. -
Page 61: Removal From Service, Decommissioning
On operational requalification, the water supply pressure must be checked against the prescribed minimum pressure. 9.3.2 Decommissioning Note For information regarding decommissioning of the DWDL and DCDL distribution systems, contact the local service support. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 62 Chapter 9: Installation Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 63: Transport And Storage
Protection from exposure to UV light Do not expose the components of the distribution system to direct sun- light (UV rays may cause premature aging of the materials). Do not store outdoors! Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 64: Environmental Compatibility/Disposal
(relating to protective clothing, storage, dosing, expiration date). The local regulations with regard to the disposal of waste water, if de- fined, must be clarified and observed before using disinfectants. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 65: Technical Safety Checks And Maintenance
To perform the Technical Safety Checks (TSC) and the maintenance procedures (MA), contact the local service support. Performance of the Technical Safety Checks must be entered in the Medical Device Register. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 66: Maintenance Procedures
(see chapter 6.6 on page 48) Visual inspection and leak- Perform a visual inspection of all Daily (see chapter 4.3.1 age check connectors and tubing containing on page 28) fluid. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 67: Specifications
The DWDL and DCDL distribution systems are planned and installed according to the local conditions regarding the length as well as the design and number of installation parts. The DWDL and DCDL distribution systems are to be regarded as per- manently installed units. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 68: Identification Label (Dwdl And Dcdl Identification)
DWDL and the DCDL. Fresenius Medical Care Type: Dialysis Water Distribution Loop 0123 REF XXXXXXXXXX *X75VXXXX* *X75VXXXX* Max. inlet pressure: 6 bar YYYY-MM-DD Fresenius Medical Care AG & Co. KGaA Else-Kröner-Str. 1 (01) (01) XXXXXXXXXXXXXX XXXXXXXXXXXXXX 61352 Bad Homburg, Germany (21) (21) XXXXXXXX... -
Page 69: Transport/Storage
Chapter 12: Specifications 12.3 Transport/storage For further information, (see chapter 10 on page 63). 12.4 Materials used For further information, (see chapter 12.1 on page 67). Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 70 Chapter 12: Specifications Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 71: Definitions
Operational qualification Start-up Operational requalification Recommissioning Permeate This term is used as a synonym for dialysis water. This term must only be used in a technical context. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 72: Abbreviations
Dialysis Concentrate Distribution Loop DWDL Dialysis Water Distribution Loop Fig. Figure (diagram) Maintenance REACH Registration, Evaluation, Authorisation and Restriction of Chemicals Reverse osmosis system SVHC Substance of Very High Concern Technical Safety Checks Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 73: Symbol
Do not use hooks! Store upright! Do not tilt! Caution: Fragile Keep dry! Warning: Hot surface Permissible temperature range Atmospheric pressure operating conditions range Relative air humidity operating conditions range Protect against sunlight (UV light)! Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 74: Certificates
Chapter 13: Definitions 13.4 Certificates Upon request the local service support will provide the currently valid versions of the certificates. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... -
Page 75: Options
Chapter 14: Options 14 Options This chapter does not contain any content applicable to this product. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 76 Chapter 14: Options Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 77: Appendix
15.1 Medical Device Register for the DWDL and DCDL 15.1.1 Responsible organization and identification The following page shows the master copy of the address of the respon- sible organization and the product identification. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 78 Classification: IIa Registration number: Identification number of the certified body: 0123 Serial number: Flexible insulation available; yes , no Manufacturer: Fresenius Medical Care & Co. KGaA, 61352 Bad Homburg Tests and checks Type Intervals Technical Safety Check (TSC)
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Page 79: Contents Of The Medical Device Register For The Dwdl And Dcdl
Chapter 15: Appendix 15.1.2 Contents of the Medical Device Register for the DWDL and DCDL The following page shows the contents of the Medical Device Register for the DWDL and DCDL distribution systems. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 80 – Training record OQ – Sampling plan OQ – Disinfection plan OQ – Start-up report OQ Performance qualification (PQ) – Results of the microbiological analysis PQ – Results of the chemical analysis PQ Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 81: Training Record
Serial number DCDL 3: Description Y/N/NA Index Important information How to use the Instructions for Use /– Warnings, significance /–/– Notes, significance /– Tips, significance /– Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 82 Cleaning connectors and connection ports /– Disinfecting connectors and connection ports /– Functional description Description of procedures /– Consumables, accessories, and additional equipment Consumables /– Accessories /– Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
- Page 83 /– 15.2 Training Record /– 15.3 Quality of dialysis water /– Comments: Note Observe index, important information, and all warnings in the In- structions for Use! Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
- Page 84 Chapter 15: Appendix Trainer Date Name Signature #FMESIG_1## #FMESIG_2## #FMESIG_3## Participant Date Function Name Signature #FMESIG_4## #FMESIG_5## Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
- Page 85 Chapter 15: Appendix Trainer Date Name Signature #FMESIG_6## #FMESIG_7## #FMESIG_8## #FMESIG_9## #FMESIG_10## #FMESIG_11## #FMESIG_12## #FMESIG_13## #FMESIG_14## #FMESIG_15## #FMESIG_16## #FMESIG_17## #FMESIG_18## Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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Page 86: Quality Of Dialysis Water
**Tests for bacterial growth and endotoxins are not required if the dialysis device’s fluid pathway is fitted with a bacteria-retentive and endotoxin-retentive filter that has an appropriate capacity, has been validated by the man- ufacturer, and is operated and monitored according to the manufacturer's instructions (e.g., DIASAFE plus). Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023... - Page 87 4 hours during operation. Online tests For online tests in the water pretreatment system, the chlorine and total hardness parameters, for example, can be monitored using AquaSENS. Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
- Page 88 Chapter 15: Appendix Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023...
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