Berlin Heart EXCOR VAD Manuals

Manuals and User Guides for Berlin Heart EXCOR VAD. We have 2 Berlin Heart EXCOR VAD manuals available for free PDF download: Instructions For Clinical Use

Berlin Heart EXCOR VAD Instructions For Clinical Use (242 pages)

Ventricular Assist Device

Brand: Berlin Heart | Category: Medical Equipment | Size: 4 MB

Table of Contents
5
Contact
13
Introduction
15
Target Audience
15
Explanation of the Safety Information and Signal Words
15
Explanation of Key Terms
16
Meaning of Text Markups
17
Symbols on Components
17
Safety Symbols
17
Symbols
18
General Information EXCOR Active
21
System Overview - Driving Unit with EXCOR VAD
21
Components and Locations of Use
22
Scope of Driving Unit Functionality
22
Intended Use
23
Use
23
Clinical Benefits
24
Indications, Contraindications, and Possible Treatment Goals
24
EMC - Electromagnetic Compatibility
24
Combination with Other Products and Procedures
25
Replacement Components
25
Information Regarding the Instructions for Use
25
Disposal of Components
26
Product Life
26
Safety Information
29
General
29
Configuration
29
Caregivers
30
Ambient Conditions
30
Diagnostic Procedure, EMC
31
Connections and User Controls
31
Power Supply
32
Operation
32
Setup and Function
33
Driving Unit
33
Principal Function
33
Setup
34
Connections and User Controls
35
Control Panel
35
Indicator Lights
35
Button
35
Display
36
Connections
43
Overview of Connections
43
Connections for LVAD, RVAD and BVAD Operating Modes
44
Connecting and Disconnecting Driving Tubes
44
Connecting the Power Supply Unit on the Driving Unit
45
Disconnecting the Power Supply Unit from the Driving Unit
45
Connecting to the Panel PC
45
Connecting the Adapter for External Alarm
46
The Flow Sensor
47
Setup
47
Measurement Precision and Alarms
50
Attaching Flow Sensors to Cannulae and Blood Pumps
50
Removing the Flow Sensor from the Cannula
51
Replacing the Sensor Quick Connect
52
Connecting / Disconnecting the Flow Sensor to / from the Driving Unit
53
Connecting the Driving Tube and Flow Sensor Cable with the Cable Wrap
53
Removing the Cable Wrap
54
Carrying System and Locking Mechanism
55
Driving Unit Setup
55
Setup of Mobile Components
56
Switching on the Driving Unit
56
Start Test for the Driving Unit
56
Driving Unit Self-Test
56
Switching off the Driving Unit
57
Power Supply
57
Batteries
58
Inserting the Batteries
58
Removing the Batteries
59
Charging Batteries in the Driving Unit
59
Charging Batteries in the Battery Charging Unit
59
Charging Replacement Batteries
59
Charging Time
60
Checking the Battery Charge Level
60
Determining Charge Level
61
Driving Unit Operating Time in Battery Mode
61
Notes on Replacing the Batteries
63
Power Supply Unit
64
Emergency Battery
64
General
64
Charging the Emergency Battery
64
The Battery Charging Unit
65
Setup
66
Function
67
Connecting Electrical Components
68
Replacing a Driving Unit
68
Replacement Driving Unit - BVAD
68
Replacing Driving Units for LVAD and RVAD Patients
70
Checking the Function of the Unconfigured Driving Unit and Panel PC
70
Configuring the Driving Unit from a File
70
Checking Configuration and Starting the Driving Unit
70
Performing a Driving Unit Replacement
71
BVAD Emergency Operation
72
Panel PC and Docking Station
73
Safety Information
73
Compatibility
73
Setup - Overview
73
Supplying Power with the Panel PC Power Supply Unit
75
Supplying Power Using Batteries
76
Inserting and Removing the Battery
76
Docking Station
77
Setup
77
Panel PC and Docking Station
78
Switching the Panel PC on and off
78
Connecting the Panel PC to a Driving Unit
79
Connection Via USB
79
User Interface
81
General
81
File and Menu Bar
82
Status Bar
83
Buttons
84
Functions of the Menu Bar
85
User Login
85
Passwords
87
User Logoff
87
Monitoring
88
Settings for the Blood Pumps
88
Parameters
88
Display of Pressure Curves
93
Settings for the Driving Unit
95
Patient Information and Driving Unit Settings
95
Blood Pumps and Cannulae
97
Settings - Overview
97
Data
98
File
98
Files
99
Options
99
System Information
101
Resetting the Driving Unit
101
Switching off the Panel PC
102
Alarm History
102
Driving Unit Data on the Panel PC
102
Progression
102
Trend Info
103
Active Alarms
104
Audio Paused
105
Ackowledged
105
Messages
106
Configuring and Operating the Driving Unit
107
General
107
Switching on the System
107
Checking the Functions
107
Checking the Functionality of an Unconfigured Driving Unit
107
Checking the Functionality of a Configured Replacement Driving Unit
108
Parameters and Configuration
108
Default Parameter Settings
108
Blood Pumps - Cannulae - Maximum Rate
109
Selection of Blood Pumps and Cannulae
110
Configuring the System
110
Configuration Options - Overview
111
Configuring the Driving Unit - MANUAL
112
Starting Configuration
112
Entering the Patient's Information
112
Selecting Settings for the Driving Unit
113
Selecting Blood Pumps and Cannulae
113
Checking the Settings and Transferring to the Driving Unit
115
Configuring the Driving Unit from a File
115
Selecting Manual / Automatic Pressure Control
116
Airing, Starting, and Setting the Blood Pumps
117
Airing the Blood Pump
117
LVAD and RVAD
117
Bvad
118
Setting Rate and Synchronization
119
Optimizing the Filling and Emptying of the Blood Pumps
119
Blood Pump Phases
120
Basic Procedure
120
Manual Pressure Control - Optimizing Filling and Emptying
121
Switching from Manual to Automatic Pressure Control
122
Automatic Pressure Control - Optimizing Filling and Emptying
122
Displaying the Pressure Curves
124
Resetting the Driving Unit
124
Measuring the Blood Flow
124
Connecting the Flow Sensors
124
Setting a Flow Alarm Threshold
125
Postoperative
126
Monitoring the Patient
126
Changing Parameters
126
Mobilizing Patients
127
Changing the Blood Pump Size
128
Changing the Operating Mode
129
Driving Unit Configuration Complete
129
Driving Unit Configuration Not yet Complete
130
Replacing and Upgrading the Blood Pump
131
Replacing the Blood Pumps - BVAD Left, LVAD, RVAD
131
Replacing the Blood Pump - BVAD Right
132
Replacing the Driving Tube
133
Replacing the Driving Tubes - BVAD Left, LVAD, RVAD
133
Replacing the Driving Tubes - BVAD Right
134
Configuring and Updating a Replacement Driving Unit
134
Configuring the Replacement Driving Unit
134
Replacement Driving Unit - Updating Configuration
135
Switching off and Restarting the Driving Unit
136
Importing and Exporting Logs
136
Types of Logs
136
Importing Logs
137
Exporting Logs
138
Deleting Logs
138
Exporting Configurations
139
Data Administration
139
Configurations
139
Replacing the Driving System
141
General
141
Ikus to EXCOR Active
141
Prerequisites for a Replacement
141
Preparing the EXCOR Active
141
Switching to the EXCOR Active
142
EXCOR Active to Ikus
143
Preparing the Ikus
143
Replacing the Driving Unit
143
Weaning and Explantation
145
General
145
Weaning the Patient
145
Performing an Explantation
145
Performing Trainings
147
Target Group for Trainings
147
Qualified Medical Personnel
147
Lay Users
147
Safety Information
147
Training Content Checklists
148
Operating Components
148
Behavior and Safety
149
Training Protocols
150
Mobile Use of the EXCOR Active
151
Help with Mobilization
151
Caddy
153
Assembly / Disassembly
153
Assembling / Disassembling the Wheels
153
Caddy - Mounting the Caster Wheels
154
Caddy with Stand
154
Inflating the Wheels
155
Attaching the Accessory Bag
155
Fastening the Hand Strap
156
Adjusting the Handle Height
156
Conversion of Caddy
157
Caddy with Stand into Caddy with Caster Wheels
157
Components
157
Assembly
157
Caddy with Caster Wheels into Caddy with Stand
158
Components
158
Assembly
158
Using the Caddy
159
Safety Information
159
Positioning the Driving Unit
159
Securing and Releasing Driving Tubes
160
Using the Locking Brake
160
Carrying the Caddy with the Driving Unit
160
Folding the Caddy into the Transport Position
160
Accessory Bag
163
Setup and Function
163
Packing the Accessory Bag
163
Baby Buggy - Stroller Board
165
Safety Information
165
General
165
Setup
165
Assembling the Stroller Board
166
Checking the Scope of Delivery
166
Overview - Assembly
167
Assembling the Stroller Board
168
Adjusting the Suspension
168
Combination with Stroller
168
Set 1 - Frame
169
Set 2 - Child Seat Fixture with Accessories
169
Set 3 - Baby Carrier Fixture
169
Using the Child Seat and Baby Seat
170
Connecting the Stroller Board to the Stroller
170
Releasing the Stroller Board from the Stroller
170
Using the Stroller Board
171
Positioning the Driving Tubes
171
Manual Pump
173
General
173
Safety Information
173
Setup
174
Supporting the Patient with the Manual Pump
175
Identifying Errors and Troubleshooting
177
Safety Information
177
Contact Person in Case of Error
177
Reporting Serious Incidents
177
Driving Unit and Panel PC Alarms
178
Alarms
178
Priority
178
Noticing Alarms Reliably
179
Alarm Times
179
Alarm Coding
179
Visual Alarms on the Driving Unit
179
Acoustic Alarms on the Driving Unit
180
Audio off
181
Saving Configurations and Logs
181
Canceling an Alarm
181
Reacting to Alarms on the Driving Unit
181
Alarms for the Driving Unit
182
Alarms on the Driving Unit
182
Panel PC Alarms
185
Panel PC Messages
187
Hemodynamic Status Alarms
187
Battery
188
Emergency Battery in Use
188
S4 after Connection to the Mains
188
S5 Pressure Build-Up Not Possible
189
S6 Flow Sensor Not Connected
189
S7 Flow Sensor Defective
189
Battery Charging Unit
189
Flow Sensor - Temperature Alarms
190
Errors Without Messages
191
Mechanical and Electronic Errors
191
Functions of the <Button
192
Unexpected Changes in Functionality
192
Analyzing Driving Unit Logs
193
Driving Tube Repair
193
No Connection between Panel PC and Driving Unit
193
User Interface too Dark or Not Reacting
194
Maintenance, Cleaning and Disinfection
195
Safety Information
195
Maintenance
195
Maintenance Personnel
195
Maintenance by Berlin Heart / Distributor
195
Intervals
195
Inspections by the Operator
196
Intervals
196
Panel PC
196
Power Supply Units
197
Docking Station
197
Battery Charging Unit
197
Stroller Board
197
Cleaning and Disinfection
197
General Rules
198
Cleaning Agents and Disinfectants, Resources
199
Cleaning Intervals
200
Cleaning and Disinfecting the Driving Unit, Batteries, and Manual Pump
201
Cleaning and Disinfecting the Flow Sensor
204
Caddy, Accessory Bag, and Stroller Board
206
Panel PC, Docking Station, Power Supply Units, Battery Charging Unit, Cable
207
Performing Functional Tests
208
Overview of Regular Activities
209
Scope of Delivery and Transport Cases
211
Contents of the Components Case
211
Contents of Driving Unit Case
212
Contents of the Flow Sensor Set
213
Optional Components
215
Replacement Part Sets for Flow Sensors
216
Technical Data
217
Driving Unit
217
Battery
217
Flow Sensor
218
Power Supply Unit for Driving Unit and Battery Charging Unit
218
Panel PC and Docking Station
219
Battery Charging Unit
220
Caddy, Stroller Board, and Stroller
220
Packaging
221
Ambient Conditions
222
Operating Conditions
222
Storage Conditions
223
Transportation and Long-Term Storage Conditions
223
Overview - Parameters
225
Parameters - Blood Pumps and Cannulae
225
Permitted BVAD Combinations
225
Permitted Combinations of Blood Pumps and Cannulae
226
Patient and Driving Unit
226
Use of the External Alarm
227
Assembling the Adapter for the External Alarm
227
Emc
229
Safety Information
229
Essential Performance Characteristics
229
Electromagnetic Emissions
230
Electromagnetic Immunity, Part 1
231
Electromagnetic Immunity, Part 2
232
Patient ID Labels
237
Abbreviations
239

Berlin Heart EXCOR VAD Instructions For Clinical Use (128 pages)

Ventricular Assist Device

Brand: Berlin Heart | Category: Medical Equipment | Size: 2 MB

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Berlin Heart EXCOR VAD Manuals

Berlin Heart EXCOR VAD Instructions For Clinical Use (242 pages)

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Berlin Heart EXCOR VAD Instructions For Clinical Use (128 pages)

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