Berlin Heart EXCOR Pediatric VAD Manuals

Manuals and User Guides for Berlin Heart EXCOR Pediatric VAD. We have 1 Berlin Heart EXCOR Pediatric VAD manual available for free PDF download: Manual

Berlin Heart EXCOR Pediatric VAD Manual (250 pages)

Ventricular Assist Device with Stationary Driving Unit

Brand: Berlin Heart | Category: Medical Equipment | Size: 30 MB

Table of Contents
5
Dear Readers
11
Important Safety Information Warnings
13
Storage and Durability
14
Transport Within the Clinic
14
Device Configurations
15
Procedural Techniques - Ikus
15
Packaging and Sterilization
17
Procedural Techniques - Pumps, Cannulae, Accessories
18
System
22
Procedures to Minimize Risk of Thrombosis
23
Cleaning the Components
23
Maintenance
24
Errors and Corrective Measures
24
Replacing the Blood Pump(S)
26
Driving Blood Pump(S) with the Manual Pump
26
Ambient Conditions
27
Interaction with Other Procedures and Therapies
27
Precautions
28
VAD Placement Technique
28
Ambient Conditions
29
Caution While on Device Support
29
Transport Outside the Clinic
30
Battery Replacement and Disposal
30
Obligations of the Operator
30
General Information
31
Device Description
31
Indications for Use
31
IDE Clinical Study Summary
31
Intended Operation Environment
31
Contraindications
32
Potential Adverse Events
32
Storage and Durability
32
Battery Replacement and Disposal
33
Manufacturer's Warranty
33
Summary of Clinical Studies
35
Indications for Use
35
Contraindications
35
Alternative Practices or Procedures
35
Marketing History
35
Potential Adverse Effects
35
IDE Clinical Study
38
IDE Clinical Study Summary
38
Study Cohorts
38
Inclusion/Exclusion Criteria
39
Study Enrollment
40
Subject Demographics
42
Results
45
Probable Benefit
45
Primary Safety
53
Death Information
56
Conclusion
57
Post Approval Study Summary
58
Study Objective
58
Study Design
58
Study Population
58
Data Source
59
Key Study Endpoints
59
Total Number of Enrolled Study Sites and Subjects, Follow-Up Rate
59
Study Visits and Length of Follow-Up
59
Results
60
Primary Safety
60
Primary Efficacy Endpoints
61
Study Strength and Weaknesses
62
Description: Blood Pump, Cannulae and Accessories
63
EXCOR Blood Pumps
64
EXCOR Cannulae
64
EXCOR Accessories
65
Description: Ikus
67
Overview
67
Displays and Operating Elements
68
Connection Panel
68
Display and Operating Panel
71
Power Supply
71
Operating Modes
72
Univentricular Operation
72
Biventricular Operation
72
Laptop Computer with Monitor Program
73
Safety
73
Redundant Design of Pneumatic Systems in Univentricular Operation
73
Redundant Design of Pneumatic Systems in Biventricular Operation
74
Control Computer with Redundancy Design
74
Battery Operation
75
Manual Pump
75
Password-Protected User Profiles (Access Passwords)
75
Instructions for Use: Ikus
77
Start Menu
78
Selecting an Option in the Start Menu
79
Configuring User Passwords
79
Saving Data on USB Stick
81
Changing Date or Time
81
Basic Instructions for Monitor Program
81
Starting the Monitor Program
81
Shutting down the Monitor Program
82
Logging in and out of the Monitor Program
82
Logging in
82
Standard View - Monitor Program
83
Selecting Monitor Program Options
84
Adjusting the Parameter Values
86
Browsing in the Message Window
87
Stopping the Blood Pump(S) and Switching off the Ikus
87
Drive Pause: Stopping the Ikus Temporarily
87
Pause Left/ Pause Right: Stopping an Individual Blood Pump
88
Drive OFF: Switching the Ikus off
88
Switching between Mains and Battery Operation
89
Changing over from Univentricular to Biventricular Operation
92
Routine Start-Test When Not in Operation
93
Moving the Ikus
94
Transportation and Packaging
94
Unloading the Ikus from the Shipping Crate
95
Loading the Ikus into the Shipping Crate
96
Cleaning and Disinfection of the Ikus
100
Commissioning the Ikus and Setting Parameters
103
Preparatory Steps Outside of the Operating Room
103
Connecting the Tank Unit
104
Switching on the Ikus
105
Starting the Monitor Program
105
Setting the Test Parameters
105
Intraoperative Drive Management
107
Disconnecting the Tank Unit from the Ikus
107
Selecting the Operating Mode (View Select Operating Mode)
107
Select the Pump Size
108
Select the Cannula Size
108
Display Pump and Cannula Sizes
109
Setting the Start-Up Parameters
110
Connecting the Blood Pump(S) to the Ikus
111
Airing the Blood Pumps in Single-Step Mode
112
Starting the Blood Pump (Changing to Standard View)
112
Checking the Parameters When the Pump Is Started and Adjusting Them
113
Switching from CPB Support to VAD Support
115
Possible Complications
116
Postoperative Drive Management
117
After Transfer to the Ward
117
Follow-Up Treatment
117
Implantation: Preparations in the Operating Room
119
Preparing the Components and Materials Required
119
Checking and Adjusting the Settings of the Cable Tie Gun
119
Unpacking the Sterile Components
121
Moving the Membrane to the End-Of-Diastole Position
122
Airing the Blood Pump
122
Inserting the De-Airing Needle
123
Rinsing and Filling the Blood Pump
123
Implantation - Surgical Procedure
125
Cannula Exit Sites
126
Use of the Cannula Tunneling Tip
127
Cannulae, Cannula Extension Set and Connecting Set
127
Description: Cannula Extension and Connecting Sets
128
Instructions for Use: Cannula Extension Set and Connecting Set
129
Access
131
Apex Cannula
131
Anastomosis of Inflow Cannula with LV Apex
132
Creating a Transcutaneous Tunnel for the LV Apex Cannula
133
Atrial Cannula(E)
134
Creating a Transcutaneous Tunnel for Atrial Cannula(E)
134
Anastomosis of Atrial Cannulae
135
Arterial Cannula(E)
136
Creating a Transcutaneous Tunnel for Arterial Cannula
136
Anastomosis of the Arterial Cannula
137
Shortening the Cannulae if Necessary
138
Connecting the Blood Pumps to the Cannulae
138
Removing the De-Airing Needle
140
Securing the Connections
140
Implantation - Anesthesia
143
Wound Care and Treatment
145
Removing the Old Dressings
146
Cleaning the Blood Pump
147
Cleaning of the Wound
147
The New Dressing
148
Preparing a New Dressing
148
Applying a New Dressing
148
Regular Checks of Blood Pump(S) and Cannulae
151
Visual Inspection: Pump Filling and Ejection
151
Visual Inspection: Deposits
152
Checks Using the Monitor Program
153
Replacing the Blood Pump Due to Growth of the Patient
154
Anticoagulation Therapy
155
Before Implantation of the EXCOR
155
General Considerations
155
Pre Implantation
155
During Implantation - Cardiopulmonary Bypass
155
Cardiopulmonary Bypass (CPB)
155
Post CPB
155
Postoperative Anticoagulation Therapy
155
Starting Anticoagulation Therapy
155
Unfractionated Heparin Therapy (I.V.) Patient < 12 Months
156
Thrombelastography (TEG®)
157
Low Molecular Weight Heparin
157
Oral Anticoagulation Therapy (Only for Patients ≥ 12 Months of Age Who Are Taking a Full Oral Diet)
157
Monitoring of Blood Count and Anticoagulation Status
158
Postoperative Platelet Inhibition Therapy
158
Start of Therapy
158
Adjunctive Medication
159
Anticoagulation Therapy
159
Therapeutic Heparin Administration and Adjustment
159
Weaning and Explantation for BTR and BTT
163
Weaning Procedure
163
Introduction
163
Indication
163
Eligibility Criteria
163
Weaning Protocol
164
Ml / 15 Ml Pump
164
30 Ml Pump
168
60 Ml Pump
172
Explantation Criteria
176
Explantation for BTR
177
Explantation with Univentricular Support
177
Explantation after Biventricular Support
177
Explantation for BTT
178
Error Messages and Corrective Measures
181
Pressure Error / Time Error in System 1 (or in System 2 or 3)
183
Throttle Valve Error in System 1 (or System 2 or 3)
183
Please Connect Driving Tube
184
Replacing a Driving Tube
184
Please Check Left / Right Pump and Driving Tube
185
Backup Operation Left/Right
186
Error Messages in Emergency Operating Mode
186
UVAD, Emergency Operation!. Contact Service Immediately
186
Emergency Operation System 1 (or System 2 or 3). Contact Service Now
187
System 1 (or System 2) Is Defective
187
System 3 (Backup) Is Defective
188
Alarm Circuit Fault: Buzzer Remains off (or On)
188
Backup Computer Faulty! Contact Customer Service
188
Backup Computer
189
Reports Discrepancy in Left/Right Pump Output Measurements
189
Reports Faulty Measurements on the Left (or Right)
189
Reports an Error in Output Measurement on the Left (or Right) Pump
189
Reports Faulty Test
190
Measurement Discrepancy in Main Computer (Backup Computer)
190
Parameter Set Update Failure
191
Temperature Sensors: <<8-Digit Binary Code
191
Fault: <<16-Digit Binary Code>> (<<Type of Fault>>)
192
Batteries Discharged; Battery Operation Not Possible
192
Insufficient Battery Charge. Only Limited Battery Operation
193
Error Messages - Circuit Breaker and Internal Battery Fuse
193
Electronic Malfunction. Contact Customer Service
193
Acoustic Alarm Is Not Properly Recognized
194
Error: no Data/No Reaction from the Control Computer
194
Left/Right Flow Sensor Defective. Notify Service
195
Problem: <<Text
196
Self-Test Is Not Completed by Passive Computer
196
Error Messages During the Start-Up Test
197
Battery Test Skipped (Battery Problem!)
197
Additional Messages During the Start-Up Test
197
Discrepancy in Pressure Measurement: System 1 (or System 2 or 3)
198
Communication with Laptop Failed
199
Troubleshooting and Correcting Faults
201
Replacing the Blood Pump(S)
205
Preparing a Replacement Blood Pump
205
Replacing the Right Blood Pump (RVAD/ BVAD)
206
Replacing the Left Blood Pump (LVAD/ BVAD)
207
Restarting Ikus
208
Emergency Pulse Mode
210
Emergency Pulse Mode - Switching the Ikus off
211
Ikus Start-Test Following Emergency Pulse Mode
211
Connecting the Patient to a Replacement Ikus
212
Driving Blood Pump(S) with the Manual Pump
214
Mains Failure or Breakdown of both Control Computers
216
Reading out the LOG Files
217
Circuit Breaker and Battery Fuse
218
Appendix
221
Overview: Product Range and Possible Combinations
221
Blood Pumps
221
Overview: Relationship: Body Weight - Pump Size
221
Apex Cannulae
222
Atrial Cannulae
222
Arterial Cannulae
222
Overview: Which Cannulae Should be Used for Which Pump
224
System Accessories
225
Driving Unit
225
Special Components
225
Maximum Rates for the Pump-Cannula Combinations
226
Blood Pump Combinations in Biventricular Mode
227
Relative Systolic Duration
227
Technical Specifications
227
Symbols and Tags
230
Sample Copy: Ikus Incoming Checklist
231
Implantation Record Form
232
Sample Copy: EXCOR Pump Log
237
Pump Performance Flow Sheet
240
EMC Tables
241
Essential Performance
241
Electromagnetic Emissions
241
Electromagnetic Immunity - Part 1
241
Electromagnetic Immunity - Part 2
242
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Ikus
244

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Berlin Heart EXCOR Pediatric VAD Manuals

Berlin Heart EXCOR Pediatric VAD Manual (250 pages)

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