Home
Berlin Heart
Medical Equipment
EXCOR Pediatric
Berlin Heart EXCOR Pediatric User Manual
212 pages
Manual
Specs
Ask a question
To Next Page
To Next Page
Loading...
EXCOR
®
Adult
EXCOR
®
Pediatric
EXCOR
®
VAD
Ventricular Assist Device
EXCOR
®
Active Driving System
Instructions for Clinical Use
Edition 1.0
2
Table of Contents
Default Chapter
5
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
System Overview - Driving Unit with EXCOR VAD
19
Components and Locations of Use
20
Scope of Driving Unit Functionality
20
Intended Use
21
Use
21
Indications, Contraindications, and Potential Therapeutic Objectives
22
EMC - Electromagnetic Compatibility
22
Combination with Other Products and Procedures
22
Replacement Components
23
Information Regarding the Instructions for Use
23
Disposal of Components
23
Product Life
24
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
Primary Function
29
Setup
30
Connections and Operation Elements
31
Control Panel
31
Indicator Lights
31
Button
31
Display
32
Connections
38
Overview of Connections
39
Connecting and Disconnecting Driving Tubes
39
Connecting the Power Supply Unit to the Driving Unit
40
Disconnecting the Power Supply Unit from the Driving Unit
40
Connecting to the Panel PC
40
Connecting the External Alarm (Nurse Call) Adapter
41
Flow Sensor
41
Setup
42
Measurement Accuracy and Alarms
44
Attaching the Flow Sensors to the Cannulae and the Blood Pumps
45
Removing the Flow Sensor from the Cannula
46
Replacing the Sensor Quick Connect
46
Connecting/Disconnecting the Flow Sensor To/From the Driving Unit
46
Guiding the Driving Tube and the Flow Sensor Cable in the Cable Wrap
47
Removing the Cable Wrap
48
Carrying System and Locking Mechanism
48
Driving Unit Setup
49
Setup of Mobile Components
49
Switching on the Driving Unit
49
Start Test for the Driving Unit
50
Driving Unit Self-Test
50
Switching off the Driving Unit
50
Power Supply
51
Batteries
51
Inserting the Batteries
52
Removing the Batteries
53
Charging Batteries in the Driving Unit
53
Charging Batteries in the Battery Charging Unit
53
Charging Replacement Batteries
53
Charging Time
53
Checking the Battery Charge Level
54
Determining the Charge Level
55
Driving Unit Operating Time in Battery Operation
56
Notes on Replacing the Batteries
57
Power Supply Unit
57
Emergency Battery
58
General
58
Charging the Emergency Battery
58
Battery Charging Unit
59
Setup
59
Function
60
Connecting Electrical Components
61
Replacing a Driving Unit
61
Replacing a Driving Unit - BVAD
61
Replacing a Driving Unit in LVAD and RVAD Patients
63
Checking the Functionality of an Unconfigured Driving Unit and Panel PC
63
Configuring the Driving Unit from File
63
Checking Configuration and Starting the Driving Unit
63
Replacing the Driving Unit
64
BVAD Emergency Operation
65
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
Parameters - Blood Pumps and Cannulae
195
Permitted BVAD Combinations
195
Permitted Combinations of Blood Pumps and Cannulae
196
Patient and Driving Unit
196
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
Need help?
Do you have a question about the Berlin Heart EXCOR Pediatric and is the answer not in the manual?
Ask a question
Berlin Heart EXCOR Pediatric Specifications
General
Brand
Berlin Heart
Model
EXCOR Pediatric
Category
Medical Equipment
Language
English
Related product manuals
Berlin Heart EXCOR Series
212 pages
Need help?
General
To Next Page