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SURDIAL
Nipro SURDIAL User Manual
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OPERATION MANUAL
SINGLE PATIENT DIALYSIS MACHINE
SURDIAL
Manufacture
r
NIPRO CORPORATION
3-9-3, Honjo-Nish
i, Kita-Ku, OSAKA
531-8510, JAPAN
PHONE +81-6-6372-2331
Version No.0R1121-0801
2
Table of Contents
Default Chapter
4
Table of Contents
4
Cautions for Safety ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ Caution-1~6
14
1 Intended Use
20
2 Contraindication
20
3 Cautions ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 3-1~2
21
4 Definitions
23
6 Installation
28
Installation Environment
28
Ambient Conditions
28
Power Supply
28
When Machine Power Rating Is AC 230V
28
Necessary Space Requirements to Use the Machine
29
Water Supply and Drainage Conditions
29
Water Quality
29
Water Supply Flow Rate
29
Water Supply Pressure
29
Water Supply Temperature
29
Concentrate Line Pressure
30
Drainage
30
Unpacking and Check of Contents
31
Procedure for Assembling
33
Cautions
33
Attachment of I.V. Pole, Hanger and Main Lamp
33
Connector for each Concentrate Container
34
Procedures for Tube and Plug Connections
35
Connections of Fluid Supply and Drain Lines, Coupler and Power Plug
35
Connection of Dialysate Coupler Tubes
35
Connection of Power Plug
35
Connection of Water Supply Port
35
Connections of Drain Port of Machine Side
35
Connection of each Concentrate
36
Connection for Disinfection
36
Connection for Water Rinsing
36
Connection to Execute Dialysis Operation(before Blood Line Connection)
36
Connection for Acetic Acid Rinsing (When Acid Rinse Option Is Not Used)
37
Connection for Acetic Acid Rinsing (When Acid Rinse Option Is Used)
37
Connection for Automatic Rinsing (1 or 2)(When Acid Rinse Option Is Used)
37
Air Purge
38
Disinfection of the Dialysate Circuit
39
Disposal of Used Machine
39
Disposal of Used Packaging Materials
39
Disposal of Blood Lines and Dialyzer
39
7 Main Functions and Components ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 7-1~2
40
8 Construction of Machine ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 8-1~14
41
Overall Construction
41
Overall Views
41
Components of Machine and Their Purposes and Functions
43
Operation Panel
45
Construction of Operation Panel
45
Components of Operation Panel and Their Purposes and Functions
46
Blood Line Setting Panel
49
Construction of Blood Line Setting Panel
49
Components of Blood Line Setting Panel and Their Purposes and Functions
50
Power Box
52
Main Lamp Assembly
53
Construction of Main Lamp Assembly
53
Components of Main Lamp Assembly and Their Purposes and Functions
54
9 Display
55
Layout of Display
57
Wake up Screen
60
Rinse Screen
61
Rinse Menu
61
Rinse Wait
62
Rinse1: Water
62
Rinse2:Chemical
62
Rnse3:Auto1 C&D
62
Rinse4: Auto2 C&D
63
Rinse Execution
64
Rinse1: Water
64
Rinse2: Chemical
64
Rinse3: Auto1 C&D
64
Rinse4: Auto2 C&D
64
Rinse End
66
Rinse1: Water
66
Rinse2:Chemical
66
Rinse3:Auto1 C&D
66
Rinse4:Auto2 C&D
66
Dialysis Screen
67
Dialysis
67
Priming
68
Test Mode
69
Settingⅰ Screen
70
Settingⅱ Screen
71
Maintenance Menu Screen
72
Alarm Screen
73
10 Alarm Functions and Resetting
74
Description of Alarms
74
Functions When Error Is Alerted
74
Procedure for Resetting
75
Actions to Respond to Alarm (Flow)
75
Table of Alarms
76
Meanings of Terms Contained in "Table of Alarms
76
Table of Alarms ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 10-3~14
78
11 Cleaning and Disinfection
89
Cleaning and Disinfection of Machine Outside
89
Machine Enclosure
89
Dialysate Concentrate Connectors and Rinse Ports
89
Cleaning and Disinfection of Fluid Lines
89
Disinfection of Fluid Line Inside
90
Concentration of Disinfectant Concentrate
90
Diluted Disinfectant Concentration and Disinfection Time
90
Method to Set Dilution Rate of Disinfectant Concentrate
91
Check of Residual Disinfectant
91
Removal of Calcium Deposit from Fluid Line Inside
92
Concentration of Acetic Acid Concentrate
92
Diluted Disinfectant Concentration and Disinfection Time
92
Concentration of Acetic Acid to be Diluted
92
Method to Set Dilution Rate of Acetic Acid Concentrate
93
Check of Residual Acetic Acid
93
12 Process Flow
94
Description of Process Flow
95
Rinse Wait Process
95
Rinse Process
95
Acid Rinse Mode
95
Disinfection/Rinse Mode
95
Dwelling Mode
95
Prerinse Mode
95
Water Rinse Mode
95
Rinse End Process
96
Dialysis Wait Process
96
Preparation Process
96
Preparation End Process
96
Dialysis Process
96
Recovery Process
96
Air Purge Process
96
13 Operation of Machine
97
Check and Action before Turning on Power Breaker
97
Procedures for Machine Operation
100
Machine SW on
100
Prerinse
100
Dialysis
101
Postrinse
101
Machine Power Breaker off
101
14 Rinsing
102
Selection of Rinsing Mode
103
Setting of Rinsing Pattern (Example: RINSE4 (AUTO2 C&D)
103
Connection of Concentrates
104
Connection of Concentrates When Acid Rinse Port (Option) Is Not Used
104
Connection at Acid Rinse
104
Connection at Disinfection/Rinse
104
Connection at Water Rinse
104
Connection of Concentrates When Acid Port Unit (Option) Is Used
105
Connection at Acid Rinse
105
Connection at Auto Rinse 1 or
105
Connection at Disinfection/Rinse
105
Connection at Water Rinse
105
Start of Rinsing (Example: RINSE4(AUTO2 C&D)
106
Completion of Rinsing
106
Discontinuance of Rinsing
107
15 Double Needle Dialysis
108
Setting of Dialysate Related Parameters
109
Setting of Dialysis Mode
109
Setting of Dialysate Concentration
109
Bicarbonate Dialysate
109
Acetate Dialysate
110
Setting of Dialysate Temperature
110
Connection of Concentrates
111
Connection of Concentrates to Prepare Bicarbonate Dialysate
111
Connection of Concentrate to Prepare Acetate Dialysate
111
Setting of Blood Line, Dialyzer and Syringe
112
Setting of Blood Line
112
Setting of Dialyzer
112
Setting of Syringe
112
Setting of Syringe Pump
112
Setting of Cross-Section Ratio of Syringe
112
Setting of Fast-Forward Volume
114
Setting of Syringe Operation Stop Time
114
Preparation of Machine (Preparation Process)
116
Check of Preparation Completion of Machine (Preparation End Process)
116
Priming Process
117
Setting of Saline Vial
117
Priming of Saline
117
Priming of Dialyzer with Dialysate
118
Rinsing of Blood Line and Dialyzer
118
When Priming Function Is Used
118
When Priming Function Is Not Used
119
Check of Dialysate Conductivity
120
Setting of UF Related Parameters
120
Connection of Patient
121
Start of Dialysis (Dialysis Process)
122
Start of Dialysis
122
Setting of Upper and Lower Venous Pressure Alarm Limits
122
Setting of Upper and Lower Arterial Pressure Alarm Limits
122
Setting of Upper and Lower Dialysate Pressure Alarm Limits
123
Completion of Dialysis (Recovery Process)
124
Check of UF Completion
124
Start of Blood Recovery
124
Execution of Blood Recovery
125
Removal of Coupler
125
Clearing Away
126
Completion of Blood Recovery
126
Discontinuance of Dialysis
127
Discontinuance of UF
127
16 Single Needle Dialysis
128
Setting of Dialysate Related Parameters
129
Setting of Dialysis Mode
129
Setting of Dialysate Concentration
129
Bicarbonate Dialysate
129
Acetate Dialysate
130
Setting of Dialysate Temperature
130
Connection of Concentrates
131
Connection of Concentrates to Prepare Bicarbonate Dialysate
131
Connection of Concentrate to Prepare Acetate Dialysate
131
Setting of Blood Line, Dialyzer and Syringe
132
Setting of Blood Line
132
Setting of Dialyzer
132
Setting of Syringe
132
Setting of Syringe Pump
133
Setting of Cross-Section Ratio of Syringe
133
Setting of Fast-Forward Volume
134
Setting of Syringe Operation Stop Time
134
Preparation of Machine (Preparation Process)
135
Check of Preparation Completion of Machine (Preparation End Process)
135
Priming Process
136
Setting of Saline Vial
136
Priming of Saline
136
Priming of Dialyzer with Dialysate
137
Rinsing of Blood Line and Dialyzer
137
When Priming Function Is Used
137
When Priming Function Is Not Used
138
Check of Dialysate Conductivity
139
Setting of UF Related Parameters
139
Connection of Patient
140
Setting of Single Needle Dialysis Related Parameters
141
Single Needle SW on
141
Setting of Single Needle Changeover Values
141
Start of Dialysis (Dialysis Process)
142
Start of Dialysis
142
Setting of Upper and Lower Arterial Pressure Alarm Limits
142
Setting of Upper and Lower Dialysate Pressure Alarm Limits
143
Completion of Dialysis (Recovery Process)
144
Check of UF Completion
144
Start of Blood Recovery
144
Execution of Blood Recovery
145
Removal of Coupler
145
Clearing Away
146
Completion of Blood Recovery
146
Discontinuance of Dialysis
147
Discontinuance of UF
147
17 Sequential Dialysis
148
ON Setting of Sequential Dialysis
148
OFF Setting of Sequential Dialysis
148
18 Check and Maintenance
150
Check and Maintenance by Operator
150
Check and Maintenance before and after Operation
150
Test Mode
150
Cleaning and Disinfection of Machine Outside
151
Disinfection and Rinsing of Fluid Line Inside
151
Acetic Acid Rinsing of Fluid Lines
151
Regular Check by Engineer
152
Check before Power on
153
Check of Leakage Current
154
Check of Accuracy of Pressure Sensor
155
Check of Syringe Pump
156
Check for Fixation of Pulley
156
Check of Accuracy of UF
157
Check of Accuracy of Blood Leak Sensor
158
Visual Check of Blood Leak Sensor
158
Zero Revisions of Blood Leak Sensor
159
Check of Accuracy of Blood Pump Flow Rate
160
When Electronic Balance Is Used
160
When Measuring Cylinder Is Used
160
Check of Accuracy of Bubble Sensor
161
Preferable Method
161
Simple Method
161
Check of Accuracy of Temperature Sensor
162
Check of Accuracy of Conductivity Cell
163
Replacement of Components of GVS Filter (Supply Water Line)
164
Replacement of Components of Electromagnetic Valve
165
Replacement of Component of Pump
168
Contents Parts List
168
Overall Views of Pump
168
Replace Method
170
Maintenance by Qualified Engineer
173
19 Storage
174
Actions before Storing Machine
174
Cleaning of Enclosure
174
Priming of Formalin Solution
174
Environmental Conditions Required to Store Machine
175
Check and Test before Re-Operation of Machine
175
20 Machine Moving and Cautions
176
21 Specifications
179
Specifications for Machine
179
Dimension and Weight
179
Power Source
179
Electric Safety
179
Environment
180
Performance of Machine
182
Dialysate Flow Rate
182
Deaeration
182
UFR Control
182
Temperature Control
182
Conductivity Control
183
Conductivity Control (ACETATE)
183
Disinfection Control
184
Acid Rinse Control
184
Water Rinse Control
184
Blood Pump
185
Syringe Pump
185
Safety Monitors
186
Bubble Detector
186
Dialysate Pressure Monitor
186
Venous Pressure Monitor
186
Blood Leak Detector
187
Conductivity Monitor
187
Temperature Monitor
187
Specifications for Options
188
Arterial Pressure Sensor
188
Backup Unit of Blood Pump for Power Failure
188
Energy Cell Specification
188
Machine Specification
188
Acid Rinse Port Unit
189
Heat Exchanger
189
Hot Chemical Disinfectant Rinse Control
189
Hot Rinse Assy
189
Hot Water Rinse
190
Large Single Lump Assy
190
Special Note
190
Language
190
22 Data for Use
191
Blood Tubing Set Applicable to SURDIAL 22.1.1 A065(A067) / V643
191
A064(A066) / V643
192
Layouts of Blood Tubing 22.2.1 Model A065(A067) / V643
194
Model A064(A066) / V643
195
Flow Chart and Components of SURDIAL
196
Flow Chart
196
Component of SURDIAL
197
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Nipro SURDIAL Specifications
General
Type
Hemodialysis Machine
User Interface
Touch screen
Manufacturer
Nipro
UF Rate
0-4000 mL/hr
Power Supply
AC100-240V 50/60Hz
Ultrafiltration Control
Volumetric
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