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Manuals and User Guides for ICU Medical Plum 360. We have
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ICU Medical Plum 360 manual available for free PDF download: Technical & Service Manual
ICU Medical Plum 360 Technical & Service Manual (254 pages)
Infuser
Brand:
ICU Medical
| Category:
Medical Equipment
| Size: 15.76 MB
Table of Contents
Section 1
5
Table of Contents
5
Figure 1-1 Plum 360 Infuser Display and Alphanumeric Keypad
10
Section 2
13
Introduction
15
Reporting Serious Incidents
15
Scope
15
Conventions
16
Table 1-1 Conventions
16
Illustrations, Screen Displays, and Software Messages
17
Labeling Symbols Glossary
17
Acronyms and Abbreviations
20
Component Designators
20
Artifacts
22
User Qualification
22
Electromagnetic Compatibility
23
Table 1-2 Standards Applicability by Labeling Inventory Code
23
Department of the Minister of Innovation, Science, and Economic Development (Canada Only)
25
Fcc Information
25
Fcc Rules, Part 15/Industry Canada
25
Instrument Implementation Procedure
26
Radio Equipment Directive
26
Rohs
26
Infuser Operation
27
Inspection
27
Unpacking
27
Alphanumeric Keypad
28
Keypads
28
Figure 1-2 Plum 360 Infuser Display and Numeric Keypad
29
Numeric Keypad
29
Self Test
30
Connectivity Check
31
Figure 1-3 Wireless Connection Available Icon
31
Figure 1-4 Main Delivery Screen Connectivity Icons
31
Figure 1-5 Ethernet Connection Available Icon
31
Figure 1-6 ICU Medical Mednet Is Active Symbol
32
Figure 1-7 Wifi Icon Versus Ethernet Icon
32
Figure 1-8 Rear View of Plum 360 with CE Module
32
Biomed
33
Biomed Access
33
Figure 1-9 Plum 360 Infuser Display and Alphanumeric Keypad
33
Figure 1-10 Plum 360 Charge Indicator Light
34
Figure 1-11 Plum 360 ON/OFF Button and Decimal Key
34
Figure 1-12 System Self Test Screen
35
Figure 1-13 Biomed Passcode Screen
35
Figure 1-14 Enter Passcode
36
Figure 1-15 Biomed Settings Menu
36
Figure 1-16 Software Request Softkey
37
Software Updates
37
Figure 1-17 Install Software Softkey
38
Figure 1-18 New Software Available Screen
38
Figure 1-19 New Software Installation in Progress
39
Figure 1-20 Device Log Shows Software Installed Successfully
40
Figure 1-21 Plum 360 Navigation Keys
41
Figure 1-22 Preventive Maintenance Menu Selection
41
Preventive Maintenance
41
Figure 1-23 PM Due Notification Screen
42
Figure 1-24 Change Battery Softkey
43
Figure 1-25 Clear Battery Warning Message
43
Figure 1-26 Set Time and Date Screen
44
Figure 1-27 Set Time and Date Screen Details
44
Set Time and Date
44
Figure 1-28 Manage Languages Menu Option
45
Figure 1-29 Language Settings Active Language
45
Manage Languages
45
Figure 1-30 Change Language Activate Softkey
46
Figure 1-31 Confirm Language Screen
46
Display Logs
47
Figure 1-32 Display Logs Screen
47
Figure 1-33 Choose Log to View Screen
47
Figure 1-34 Alarm and Device Logs
48
Figure 1-35 Infuser Settings Menu Option
48
Infuser Settings
48
Figure 1-36 Infuser Settings Screen
49
Figure 1-37 Infuser Defaults Screen
49
Infuser Defaults
49
Display Defaults
50
Table 1-3 Infuser Default Settings
50
Figure 1-38 Display Defaults Screen
51
Table 1-4 Display Default Parameters
51
Figure 1-39 Calibration Test Step 1 of 2 Screen
52
Figure 1-40 Calibration Test Step 2 of 2 Screen
53
Figure 1-41 Programming Options Screen
53
Programming Options
53
About Device
54
Figure 1-42 about Device Screen
54
Table 1-5 Programming Option Parameters
54
Figure 1-43 Manage Network Menu Option
55
Manage Network
55
Figure 1-44 Network Settings CE 3.0 Screen
56
Figure 1-45 Wireless Settings Menu Option
56
Wireless Settings
56
Ethernet Settings
57
Figure 1-46 Wireless Settings Screen
57
Figure 1-47 Ethernet Settings Menu Option
57
Figure 1-48 Ethernet Settings Screen
58
Figure 1-49 ICU Medical Mednet Settings Menu Option
58
Icu Medical Mednet Settings
58
Figure 1-50 ICU Medical Mednet Settings Screen
59
Figure 1-51 Reset Network to Default Settings Menu Option
59
Reset Network to Default Settings
59
Enable/Disable Web Config
60
Figure 1-52 Reset Network Settings Screen
60
Figure 1-53 Web Config Is Disabled Menu Option
60
Enable/Disable Mobile Service Mode
61
Figure 1-54 Web Config Is Enabled Menu Option
61
Shutdown Ce
62
Suspected Cybersecurity Event or Threat
64
Taiwan Ncc Warning Statement
64
Warranty
65
System Operating Manual
67
Battery
69
Battery Charger
69
Service Support
69
Cleaning and Disinfection
71
Maintenance and Service Tests
71
Approved Cleaning Solutions
72
Cleaning
72
Table 5-1 Cleaning Solution
72
Cleaning Supplies
73
Preparing the Infuser for Cleaning
73
General Cleaning Instructions
74
Table 5-2 Cleaning Methods
74
Cleaning Exterior Surfaces
75
Table 5-3 Time Intervals for Cleaning
75
Cleaning the Cassette Receptacle
77
Cleaning Infuser Accessories
80
Cleaning the Power Cord Velcro Strap
80
Drying the Infuser
80
Rinsing the Infuser
80
Cleaning Spills During the Course of Patient Care
81
Approved Disinfecting Solutions
82
Disinfecting Supplies
82
Disinfection
82
Preparing the Infuser for Disinfection
82
Table 5-4 Disinfecting Solutions
82
General Disinfection Instructions
83
Table 5-5 Disinfection Methods
83
Table 5-6 Minimum Time Intervals for Disinfecting
83
Disinfecting Exterior Surfaces
84
Disinfecting Accessories
85
Disinfecting the Cassette Door and Receptacle
85
Disinfecting the Power Cord Velcro Strap
85
Drying the Infuser
86
Rinsing the Infuser
86
Preparation for Maintenance and Testing
87
Testing Equipment List
87
Basic Test Setup
88
Test Setups
88
Distal Occlusion Test Setup
97
Proximal Air-In-Line Test Setup
100
Distal Air-In-Line Test Setup
101
Priming a Run-In Cassette Assembly
102
Preventive Maintenance
105
Preventive Maintenance Checklist
107
Labels Inspection
108
Ac (Mains) Power Cord, Retainer, and Velcro Strap Inspection
110
Front Enclosure, Rear Enclosure, Cassette Door, and Door Lever Inspection and Test
111
Door Roller Inspection and Test
113
Fluid Shield Inspection
113
Distal Pressure Pin Inspection
115
Proximal Pressure Pin Inspection
116
Pole Clamp Inspection and Test
118
Rubber Foot Pad Inspection
118
Keypad Inspection
120
Battery Inspection and Replacement
121
Display and Indicators Inspection
123
Cassette Alarm Test
124
Distal Occlusion Test
124
Display Test
128
Keypad Verification Test
128
Unrestricted Flow Test
128
Proximal Occlusion and Alarm Loudness Test
129
Distal Air-In-Line Test
130
Proximal Air-In-Line Test
131
Delivery Accuracy Test
132
Connectivity Test
133
Nurse Call Test
133
Electrical Safety Test
135
Table 5-7 Electrical Safety Measurements (PM)
135
End of Preventive Maintenance
136
Performance Verification Test
137
Performance Verification Test Checklist
138
Cassette Alarm Test (Pvt)
139
Distal Occlusion Test (Pvt)
139
Unrestricted Flow Test (Pvt)
142
Display Test (Pvt)
143
Keypad Verification Test (Pvt)
145
Proximal Occlusion and Alarm Loudness Test (Pvt)
146
Distal Air-In-Line Test (Pvt)
147
Proximal Air-In-Line Test (Pvt)
147
Delivery Accuracy Test (Pvt)
148
Nurse Call Test (Pvt)
149
Electrical Safety Test (Pvt)
151
Table 5-8 Electrical Safety Measurements (PVT)
151
End of the Pvt
152
Technical Assistance
153
Troubleshooting
153
Alarm Messages and Alarm Codes
154
Operational Alarm Messages and Codes
154
Table 6-1 Operational Alarm Messages and Corrective Actions
154
Alarm Codes Requiring Technical Service
163
Table 6-2 Alarm Codes Requiring Technical Service
163
Table 6-3 Troubleshooting with the PVT
170
Troubleshooting Procedures
170
Unrestricted Flow
172
Resetting the Network Settings to Factory Defaults
173
Resetting the Infuser Settings (Software Version 15.11 and Later)
174
Replaceable Parts
177
Replaceable Parts and Repairs
177
Replacement Procedures
177
Safety and Equipment Precautions
177
Required Tools and Materials
178
Rubber Foot Pad Replacement
178
Battery, Wire Harness, Door, and Door Pad Replacement
179
Ac (Mains) Power Cord, Retainer, and Velcro Strap Replacement
182
Ce Module Replacement
183
Ce Module Component Replacement
185
Antenna Pwa Replacement
186
Volume Control Knob Replacement
186
Ce Module Cover Replacement
187
Separating the Front Enclosure, Rear Enclosure, and Main Chassis
188
Front Enclosure, Rear Enclosure, or Main Chassis Replacement
190
Front Enclosure Component Replacement
191
Rear Enclosure Component Replacement
193
Pole Clamp Assembly, Pole Clamp Bracket, Handle Bracket, and Insulator Replacement
194
Pole Clamp Shaft/Knob Assembly and Shaft Tip Replacement
195
Rear Enclosure Gasket Replacement
195
Minipole Assembly Replacement
196
Main Chassis Assembly Component Replacement
198
Power Supply Pwa Replacement
199
Keypad Replacement
200
Display Assembly Replacement
201
Cpu Pwa Replacement
203
Piezo Alarm Assembly Replacement
209
Infusion Mechanism Assembly Replacement
210
Infusion Mechanism Chassis Gasket Tape Installation
212
Cassette Door and Fluid Shield Replacement
213
Door Handle Assembly Replacement
218
Specifications
219
Drawings
223
Table 9-1 Drawings
223
Appendix
243
Table A-1 Guidance and Manufacturer's Declaration - Electromagnetic Emissions
243
Table A-2 Guidance and Manufacturer's Declaration - Electromagnetic Immunity
244
(60601-1-2 Edition 3 Compliance
246
Life-Supporting ME Equipment and ME Systems
246
Table A-3 Guidance and Manufacturer's Declaration - Electromagnetic Immunity for Life-Supporting Equipment and Systems (60601-1-2 Edition 3 Compliance
246
Table A-4 Recommended Separation Distances between Portable and Mobile
248
Table A-5 Guidance and Manufacturer's Declaration - Electromagnetic Emissions
249
Table A-6 Guidance and Manufacturer's Declaration - Electromagnetic Immunity
250
(60601-1-2 Edition 4 Compliance
251
Table A-7 Guidance and Manufacturer's Declaration - Electromagnetic Immunity for Life-Supporting Equipment and Systems (60601-1-2 Edition 4 Compliance
251
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