Fresenius Medical Care Dialysis Water Distribution Loop Manuals

Manuals and User Guides for Fresenius Medical Care Dialysis Water Distribution Loop. We have 1 Fresenius Medical Care Dialysis Water Distribution Loop manual available for free PDF download: Instructions For Use Manual

Fresenius Medical Care Dialysis Water Distribution Loop Instructions For Use Manual (88 pages)

Brand: Fresenius Medical Care | Category: Medical Equipment | Size: 2.54 MB

Table of Contents
3
Index
7
Important Information
9
How to Use the Instructions for Use
9
Warnings, Significance
10
Notes, Significance
10
Tips, Significance
10
Brief Description
11
Intended Purpose and Related Definitions
12
Intended Purpose
12
Medical Indication
12
Intended Patient Population
12
Intended User Group and Intended Environment
12
Side Effects
13
Contraindications
13
Residual Risks
14
Interaction with Other Systems
15
Intended Combined Use
15
Therapy Restrictions
15
Considerations for Working on the DWDL and DCDL
15
Expected Service Life
16
Duties of the Responsible Organization
16
Further Aspects of the Responsible Organization
16
Operator Responsibility
17
Reporting Incidents
17
Disclaimer of Liability
18
Technical Documentation
18
Warnings
19
Basic Warnings
19
Warnings Related to Hygiene and Biology
21
Svhc (Reach)
22
Addresses
23
Structure and Views
25
Overall View of the Distribution Systems
25
Overall View of DWDL
26
Overall View of DCDL
26
Operation
27
Overview of Coupling Systems on the Media Supply Systems
27
Mediac
27
Mediap
27
Mediar
27
Observe When Operating
28
Operating the Coupling Systems
28
To be Observed before Connecting the Hemodialysis Device
28
Connecting and Disconnecting
29
Microbiological Analysis at the Sampling Port
31
Preparation
31
Accessories, Equipment
31
Procedure for Collecting a Sample at the Sampling Port
32
Microbiological Analysis at the Dialysis Water Connection
34
Preparation
34
Accessories, Equipment
34
Procedure for Collecting a Sample at the Dialysis Water Connection
35
Collecting a Sample for Chemical Analysis
36
Preparation
36
Accessories, Tools
36
Procedure for Collecting a Sample for Chemical Analysis
37
Alarms
39
Cleaning, Disinfection
41
Generally Applicable Regulations for Cleaning and Disinfection
41
Precautions
41
Operator Safety
41
Surface Cleaning, Surface Disinfection
43
Surface Cleaning
43
Cleaning Agents for Surfaces
43
Surface Disinfection
43
Surface Disinfectant
44
Disinfecting the DWDL
45
Reasons for Disinfecting the DWDL
45
Disinfecting the System
45
Cleaning Connectors and Connection Ports
47
Cleaning the Connectors
47
Cleaning the Connection Ports
47
Disinfecting Connectors and Connection Ports
48
Disinfecting the Connectors
48
Disinfecting the Connection Ports
49
Functional Description
51
Description of Procedures
51
Functions
51
Consumables, Accessories, and Additional Equipment
53
Consumables
54
Accessories
55
Accessories for the DCDL Distribution System
55
Accessories for the DWDL Distribution System
56
Additional Equipment
58
Additional Equipment for the DWDL Distribution System
58
Additional Equipment for the DCDL Distribution System
58
Installation
59
Installation Requirements
59
General Information
59
Environmental Conditions
59
Structural Installation Requirements
59
Operational Qualification
60
To be Observed before the Operational Qualification
60
Operational Qualification Procedure
60
Removal from Service, Decommissioning
61
Removal from Service
61
Decommissioning
61
Transport and Storage
63
Transport and Storage Conditions
63
Environmental Compatibility/Disposal
64
Handling of Disinfectants
64
Technical Safety Checks and Maintenance
65
Important Information for Performing the TSC/MA
65
Maintenance Procedures
66
Quality Assurance and Care Measures
66
Specifications
67
DWDL and DCDL Product Data
67
Identification Label (DWDL and DCDL Identification)
68
Transport/Storage
69
Materials Used
69
Definitions
71
Definitions and Terms
71
Abbreviations
72
Symbol
73
Certificates
74
Options
75
Appendix
77
Medical Device Register for the DWDL and DCDL
77
Responsible Organization and Identification
77
Contents of the Medical Device Register for the DWDL and DCDL
79
Training Record
81
Quality of Dialysis Water
86

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