Berlin Heart EXCOR Adult Manuals

Manuals and User Guides for Berlin Heart EXCOR Adult. We have 3 Berlin Heart EXCOR Adult manuals available for free PDF download: Instructions For Clinical Use

Berlin Heart EXCOR Adult 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 Adult Instructions For Clinical Use (212 pages)

Ventricular Assist Device Active Driving System

Brand: Berlin Heart | Category: Medical Equipment | Size: 3 MB

Table of Contents
5
1 Contact

13
2 Introduction

15
- Target Audience
  15
- Explanation of the Safety Information and Signal Words
  15
- Terms
  16
- Meaning of Text Markups
  17
- Pictograms on Components
  17
- Safety Symbols
  17
- Symbols
  18
3 General Information EXCOR Active

19
4 Safety Information

25
- General
  25
- Configuration
  25
- Caregivers
  26
- Ambient Conditions
  26
- Diagnostic Procedures, EMC
  27
- Connections and Operation Elements
  27
- Power Supply
  28
- Operation
  28
Driving Unit Structure and Function

29
6 Panel PC and Docking Station

67
- Safety Information
  67
- Setup - Overview
  67
- Supplying Power Via Power Supply Unit
  69
- Supplying Power Using Batteries
  69
- Inserting and Removing the Battery
  69
- Docking Station
  70
- Setup
  70
- Panel PC and Docking Station
  71
- Switching the Panel PC on and off
  71
- Connecting the Panel PC to the Driving Unit
  72
- Connection Via USB
  72
7 User Interface

73
- General
  73
- File and Menu Bar
  74
- Status Bar
  75
- Buttons
  76
- Functions of the Menu Bar
  77
- User Login
  77
- Passwords
  79
- User Log off
  79
- Monitoring
  79
- Settings for the Blood Pumps
  80
- Parameter
  80
- Display of Pressure Curves
  84
- Settings for the Driving Unit
  85
- Patient Information and Driving Unit Settings
  85
- Blood Pumps and Cannulae
  86
- Settings - Overview
  87
- Data
  88
- Files
  88
- Options
  88
- System Information
  89
- Resetting the Driving Unit
  89
- Switching off the Panel PC
  90
- Alarm History
  91
- Progression
  91
- Trend Info
  91
- Active Alarms
  93
- Audio Paused
  93
- Messages and Help
  93
- Messages
  93
- Help
  93
8 Configuring and Operating the Driving Unit

95
- General
  95
- Switching on the System
  95
- Checking Functions
  95
- Checking Functionality of an Unconfigured Driving Unit
  95
- Checking Functionality of a Configured Replacement Driving Unit
  96
- Parameters and Configuration
  96
- Default Parameter Settings
  96
- Blood Pumps - Cannulae - Maximum Rate
  97
- Selecting Blood Pumps and Cannulae
  97
- Configuring the System
  98
- Configuration Options - Overview
  98
- Configuring a Driving Unit - MANUAL
  99
- Starting Configuration
  99
- Entering Patient Information
  99
- Selecting Settings for the Driving Unit
  100
- Selecting Blood Pumps and Cannulae
  100
- Checking Settings and Transferring to the Driving Unit
  101
- Configuring the Driving Unit from File
  101
- Airing, Starting, and Setting the Blood Pumps
  102
- Airing the Blood Pump
  102
- LVAD and RVAD
  102
- Bvad
  103
- Setting Rate and Synchronization
  104
- Optimizing the Filling and Emptying of the Blood Pumps
  105
- Blood Pump Phases
  105
- Basic Procedure
  105
- Piston Stroke and Mean Driving Pressure
  106
- Optimizing Filling and Emptying
  106
- Setting the Parameter Duration Systole
  107
- Displaying the Pressure Curves
  107
- Resetting the Driving Unit
  108
- Measuring the Blood Flow
  108
- Connecting the Flow Sensor
  108
- Setting a Flow Alarm Threshold
  109
- Postoperative
  110
- Monitoring the Patient
  110
- Changing Parameters
  110
- Mobilizing Patients
  111
- Changing the Blood Pump Size
  112
- Changing the Operating Mode
  113
- Replacing and Upgrading the Blood Pump
  114
- Replacing Blood Pumps - BVAD Left, LVAD, RVAD
  114
- Replacing the Blood Pump - BVAD Right
  115
- Replacing the Driving Tube
  116
- Replacing Driving Tubes - BVAD Left, LVAD, RVAD
  116
- Replacing Driving Tubes - BVAD Right
  117
- Configuring and Updating the Replacement Driving Unit
  117
- Configuring the Replacement Driving Unit
  117
- Replacement Driving Unit - Updating Configuration
  118
- Types of Data
  119
- Configurations
  119
- Logs
  119
- Managing Data
  119
9 Replacing the Driving System

123
- General
  123
- From Ikus to EXCOR Active
  123
- Prerequisites for a Replacement
  123
- Preparing EXCOR Active
  123
- Switching to EXCOR Active
  124
- From EXCOR Active to Ikus
  125
- Preparing the Ikus
  125
- Replacing the Driving Unit
  125
10 Weaning and Explantation

127
- General
  127
- Weaning the Patient
  127
- Performing an Explantation
  127
11 Performing Trainings

129
- Target Group for Trainings
  129
- Qualified Medical Personnel
  129
- Lay Users
  129
- Safety Information
  129
- Training Content Checklists
  130
- Using Components
  130
- Behavior and Safety
  131
- Training Log
  132
12 Mobile Use of EXCOR Active

133
- Help with Mobilization
  133
13 Caddy

135
- Setup
  135
- Assembly - Disassembly
  135
- Adjusting the Stand
  135
- Mounting - Dismounting the Wheels
  136
- Inflating the Tires
  136
- Attaching the Accessory Bag
  137
- Fastening the Hand Strap
  137
- Adjusting the Handle Height
  137
- Using the Caddy
  138
- Safety Information
  138
- Positioning the Driving Unit
  138
- Securing and Releasing the Driving Tubes
  139
- Using the Brake
  139
- Carrying the Caddy with the Driving Unit
  139
- Folding the Caddy into Transport Position
  139
14 Accessory Bag

141
- Design and Function
  141
- Packing the Accessory Bag
  141
15 Baby Buggy - Stroller Board

143
- Safety Information
  143
- General
  143
- Setup
  143
- Mounting the Stroller Board
  143
- Checking the Scope of Delivery
  143
- Overview - Assembly
  145
- Mounting the Stroller Board
  146
- Adjusting the Suspension
  146
- Combination with the Stroller
  146
- Set 1 - Frame
  147
- Set 2 - Child Seat Fixture with Accessories
  147
- Set 3 - Baby Seat Fixture
  147
- Using the Child Seat and the Baby Seat
  147
- Attaching the Stroller Board to the Stroller
  148
- Releasing the Stroller Board from the Stroller
  148
- Using the Stroller Board
  148
- Positioning the Driving Tubes
  149
16 Manual Pump

151
- General
  151
- Safety Information
  151
- Setup
  152
- Supporting the Patient with the Manual Pump
  153
17 Identifying Errors and Troubleshooting

155
- Safety Information
  155
- Contact Person in Case of Error
  155
- Contact Person Regarding Errors
  155
- Reporting Serious Incidents
  155
- Driving Unit and Panel PC Alarms
  156
- Alarms
  156
- Priority
  156
- Perceiving Alarms Reliably
  157
- Alarm Times
  157
- Alarm Coding
  157
- Visual Alarms on the Driving Unit
  157
- Audible Alarms on the Driving Unit
  158
- Audio off
  159
- Saving Configurations and Logs
  159
- Canceling an Alarm
  159
- Reacting to Driving Unit Alarms
  159
- Driving Unit Alarms
  160
- Alarms on the Driving Unit
  160
- Panel PC Alarms
  162
- Panel PC Messages
  164
- Alarms H1 and H2
  165
- Battery
  165
- P6 Emergency Battery in Use
  166
- Battery Charging Unit
  166
- Flow Sensor - Temperature Alarms
  166
- Errors Without Messages
  167
- Unexpected Changes in Functionality
  168
- Driving Tube Repair
  168
18 Maintenance, Cleaning and Disinfection

171
- Safety Information
  171
- Maintenance
  171
- Maintenance Personnel
  171
- Maintenance by the Manufacturer / Distributor
  171
- Intervals
  171
- Inspections by the Operator
  172
- Intervals
  172
- Panel PC
  172
- Power Supply Units
  172
- Docking Station
  173
- Battery Charging Unit
  173
- Cleaning and Disinfection
  173
- General Rules
  173
- Cleaning Agents and Disinfectants, Resources
  174
- Cleaning Intervals
  174
- Notes on Cleaning and Disinfecting Components
  176
- Performing Functional Tests
  177
- Overview of Regular Actions
  178
19 Scope of Delivery and Transport Cases

181
- Contents of the Components Case
  181
- Contents of the Driving Unit Case
  182
- Flow Sensor Set Contents
  183
- Optional Components
  185
20 Technical Specifications

187
- Driving Unit
  187
- Battery
  187
- Flow Sensor
  188
- Power Supply Unit for Driving Unit and Battery Charging Unit
  188
- Panel PC and Docking Station
  189
- Battery Charging Unit
  190
- Caddy, Stroller Board
  190
- Packaging
  191
- Ambient Conditions
  192
- Operating Conditions
  192
- Storage Conditions
  193
- Transport Conditions and Long-Term Storage Conditions
  193
21 Overview - Parameters

195
22 Using the External Alarm (Nurse Call)

199
- Assembling the External Alarm (Nurse Call) Adapter
  199
23 Emc

201
- Safety Information
  201
- Major Performance Characteristics
  201
- Electromagnetic Emissions
  202
- Electromagnetic Immunity, Part 1
  203
- Electromagnetic Immunity, Part 2
  204
24 Patient ID Labels

207
Abbrevations

209

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

Ventricular Assist Device

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

Berlin Heart Categories

Medical Equipment

More Berlin Heart Manuals

Berlin Heart EXCOR Adult Manuals

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

Table of Contents

Berlin Heart EXCOR Adult Instructions For Clinical Use (212 pages)

Table of Contents

1 Contact

2 Introduction

3 General Information EXCOR Active

4 Safety Information

Driving Unit Structure and Function

6 Panel PC and Docking Station

7 User Interface

8 Configuring and Operating the Driving Unit

9 Replacing the Driving System

10 Weaning and Explantation

11 Performing Trainings

12 Mobile Use of EXCOR Active

13 Caddy

14 Accessory Bag

15 Baby Buggy - Stroller Board

16 Manual Pump

17 Identifying Errors and Troubleshooting

18 Maintenance, Cleaning and Disinfection

19 Scope of Delivery and Transport Cases

20 Technical Specifications

21 Overview - Parameters

22 Using the External Alarm (Nurse Call)

23 Emc

24 Patient ID Labels

Abbrevations

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

Table of Contents

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