Fresenius Medical Care AquaA Manuals

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

Fresenius Medical Care AquaA Instructions For Use Manual (240 pages)

Water Purification System

Brand: Fresenius Medical Care | Category: Water Filtration Systems | Size: 5 MB

Table of Contents
3
Important Information
13
How to Use the Instructions for Use
14
Significance of Warnings
16
Significance of Notes
16
Significance of Tips
16
Brief Description
17
Indications for Use
17
Intended Purpose and Related Definitions
18
Intended Purpose
18
Medical Indication
18
Intended Patient Population
18
Intended User Group and Intended Environment
18
Side Effects
18
Contraindications
19
Residual Risks
20
Interaction with Other Systems
21
Intended Combined Use
21
Restrictions
21
Considerations for Working on the Device
21
Expected Service Life
22
Duties of the Responsible Organization
22
Further Aspects of the Responsible Organization
22
Operator Responsibility
24
When Entering Parameters, the Following Must be Observed
24
Disclaimer of Liability
25
Technical Documentation
25
Warnings
25
Basic Warnings
26
Warnings Related to Hygiene and Biology
28
Electrical Warnings
30
Patents
30
Addresses
31
Design
33
Views
33
Complete Device
33
Front View/Rear View
34
Side View
35
Controls and Indicators
36
User Interface
37
Display/Touch Screen
39
Operation
41
Turning the Device On/Off
41
Turning the Device on
41
Turning the Device off
42
Operating States, Sub-Operating Modes, Access Permissions
43
Device Status STANDBY
44
Booting the System
44
STANDBY Operating State
45
STANDBY-Active
45
STANDBY-Warning
46
STANDBY-P Storage (Permeate or Dialysis Water Storage)
46
STANDBY-Permeate Stop
46
STANDBY-External Locking
46
SUPPLY Operating State
48
SUPPLY-Start Test
49
SUPPLY-Active
50
Yield Control
50
Continuous Control
50
Intermittent Control
50
SUPPLY-DIV. to Drain
50
SUPPLY-Permeate Stop
51
SUPPLY-Warning
51
SUPPLY-External Locking
51
SUPPLY-Fill Tank
52
SUPPLY-Changing the Autostop Time
53
RINSE Operating State
54
Preparing for RINSE
56
RINSE-Active
57
RINSE-Water Pretreatment
58
DISINFECTION Operating State
59
EMERGENCY MODE Operating State
60
General Information
60
Turning Aquaa EMERGENCY MODE on
62
Turning Aquaa EMERGENCY MODE off
63
Aquaa2 EMERGENCY MODE (Option)
64
Turning Aquaa2 EMERGENCY MODE on
65
Turning Aquaa2 EMERGENCY MODE off
66
Aquauf EMERGENCY MODE (Option)
67
Failure
68
STATUS-Menu
69
STATUS-Messages
71
STATUS-Report
72
Daily Report Aquaa
72
Daily Report Aquaa2
73
STATUS-Start/Stop
76
Switching Program-Supply
76
Switching Program-Rinse
77
Switching Program-Heat Disinfection
79
STATUS-System Information
80
System Information-Device Configuration
80
STATUS System Information-Aquaa2
81
STATUS System Information-Aquaht
82
STATUS-Operating Data
83
STATUS-Operating Data-Aquaa
83
STATUS-Operating Data-Aquaa2
87
STATUS-Operating Data-Aquaht
90
SETUP/SERVICE Menu
92
System Menu
93
General Information on Entering the Password
93
SYSTEM -Settings
95
SETTINGS-Report (Password-Protected)
96
SETTINGS-Switching Program (Password-Protected)
96
Programming the Switching Programs
97
SETTINGS-Cleaning (Password-Protected)
98
SETTINGS-Time/Date
102
SETTINGS-Language
103
SETTINGS-Display Contrast (Password-Protected)
104
SYSTEM-Service (Only with Password)
104
Access with Password
104
Change Password
105
Alarms
109
Messages
109
Alarm Message Types
109
Contact Details for the Service Department
110
Alarm Description
111
Identification of the Error Code
111
Significance of a Fault, Failure
111
Significance of a Warning, Warning Condition
111
Error Category 01-System and Hardware Problems
112
Error Category 02-Violation of Alarm Limits
114
Error Category 03-Start Condition Not Fulfilled
119
Error Category 04-Start Test and Test Routines
121
Alarms and Information Messages-Aquaht (Option)
123
Alarms and Information Messages-Aquaa2 (Option)
127
Cleaning, Disinfection, Preservation
131
Generally Applicable Regulations for Cleaning, Disinfection and Preservation
131
General Information
131
Reasons for Disinfecting the Device
132
Requirements for the Clinic Technician (Clinic Technician Training)
132
Precautions
133
Patient Safety
133
Operator Safety
134
Disinfection
135
General Notes
135
Disinfecting the System
135
Preservation
136
Surface Cleaning
136
General Information
136
Surface Disinfection
137
General Information
137
Surface Disinfectant
137
Functional Description
139
Description of the Procedure
139
Functions
139
Ringbase
139
Ringunit (Option)
140
Flow Diagrams
140
Consumables, Accessories, Additional Equipment
141
Consumables
142
Additional Equipment/Options
143
Modules/Accessories
144
Installation
145
Installation Requirements
145
General Information
145
Environment
145
Power Supply System (Electrical)
146
Operational Qualification
147
To be Observed before Operational Qualification
147
System-Specific Requirements
148
General Information
148
Hydraulic Connection Requirements
148
Requirements for Electric Connections
148
Operational Qualification Procedure
149
After Operational Qualification
149
Decommissioning / Shutdown / Operational Requalification
150
Decommissioning
150
Shutdown
150
Operational Requalification
150
Transport/Storage
153
Transport and Storage Conditions
153
Transport
154
Environmental Compatibility/Disposal
154
Technical Safety Checks and Maintenance
155
Important Information for the Procedure
155
Maintenance Procedures
155
Specifications
157
Dimensions and Weight
157
Device Data
157
Identification Label (Device Identification)
158
Electrical Safety
159
Electrical Supply
160
Fuses
160
Information on Electromagnetic Compatibility (IEC 60601-1-2)
162
Essential Performance
162
Minimum Distances between Radiation Source and Medical Electrical Equipment
162
Guidance and Manufacturer's Declaration on EMC
164
Operating Conditions
167
Transport/Storage
169
External Connection Options
169
Materials Used
172
Device Materials
172
Specifications-Aquaa2
173
Specifications-Aquaht
177
Specifications-Aquauf
181
Definitions
183
Definitions and Terms
183
Abbreviations
183
Symbols
184
Certificates
185
Options
187
Aquaa2
187
Preface
187
Functional Description-Aquaa2
188
Design-Aquaa2
189
Operating Modes-Aquaa2
190
STANDBY Device Status-Aquaa2
190
SUPPLY Mode-Aquaa2
190
RINSE Mode-Aquaa2
190
DISINFECTION Mode-Aquaa2
190
EMERGENCY MODE Mode-Aquaa2
190
STATUS Start/Stop-Aquaa2
190
Cleaning, Disinfection, Preservation-Aquaa2
191
Consumables, Accessories, Additional Accessories-Aquaa2
191
Aquaht
192
Preface
192
Functional Description-Aquaht
193
Design-Aquaht
194
HEAT DISINFECTION Mode-Aquaht
196
SUPPLY Mode-Aquaht
209
RINSE Mode-Aquaht
209
DISINFECTION Mode-Aquaht
209
Cleaning, Disinfection, Preservation-Aquaht
210
Functional Description-Aquaht
210
Consumables, Accessories, Additional Accessories-Aquaht
211
Ultrafilter Aquauf
212
Functional Description-Aquauf
212
Design-Aquauf
213
SUPPLY Mode-Aquauf
214
RINSE Mode-Aquauf
214
DISINFECTION Mode-Aquauf
214
HEAT DISINFECTION Mode-Aquauf
214
Cleaning, Disinfection, Preservation-Aquauf
214
Tsdiag+-Diagnostics Tool
215
Starting the Tsdiag
215
Appendix
219
Aquaa Medical Device Register
219
Responsible Organization and Identification
219
Contents of the Aquaa Medical Device Register
221
Aquaa-Training Record
223
Operational Data Acquisition
229
Manual Operational Data Acquisition Report
229
Manual Operational Data Acquisition Report
231
Quality of Dialysis Water
232
Collecting a Sample at the Aquaa for Microbiological Analysis
234
Preparation
234
Accessories, Equipment
234
Collecting a Sample on the Aquaa
234
Collecting a Sample for Microbiological Analysis
237
Preparation
237
Accessories, Equipment
237
Collecting a Sample on the MSC
238
Collecting a Sample for Chemical Analysis
239
Preparation
239
Accessories, Equipment
239

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Fresenius Medical Care AquaA Instructions For Use Manual (240 pages)

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