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HEARTMATE II
Thoratec HEARTMATE II Manuals
Manuals and User Guides for Thoratec HEARTMATE II. We have
5
Thoratec HEARTMATE II manuals available for free PDF download: Instructions For Use Manual, Patient Handbook, Replacing Manual, Pocket Manual
Thoratec HEARTMATE II Instructions For Use Manual (548 pages)
LEFT VENTRICULAR ASSIST SYSTEM
Brand:
Thoratec
| Category:
Medical Equipment
| Size: 33 MB
Table of Contents
Table of Contents
7
Preface
11
Introduction
13
Understanding Warnings and Cautions
15
Overview
16
Adverse Events
19
Contraindications
19
Indications
19
Pre-Use Requirements
20
Equipment Overview
21
Required, Backup, and Optional Components & Equipment
25
Principles of Operation
27
Explanation of Parameters
29
2 System Operations
31
Heartmate II Left Ventricular Assist Device Overview
33
System Controller Overview
40
The Backup System Controller
75
Powering the System
87
Power Overview
89
3 Powering the System
90
Using the Power Module
90
Using the Mobile Power Unit
116
Using Heartmate 14 Volt Lithium-Ion Batteries
131
Switching Power Sources
144
Battery Charger Overview
151
Charging Heartmate Batteries
157
Calibrating Heartmate 14 Volt Lithium-Ion Batteries
160
Using the Charger to Check Battery Power
162
Care and Maintenance of the Battery Charger
163
System Monitor
165
Overview
167
4 System Monitor
168
System Monitor Setup
169
System Monitor Interface
173
Clinical Screen
174
Clinical Screen
180
Settings Screen
184
Alarms Screen
193
Save Data Screen
198
History Screen
204
Admin Screen
206
Surgical Procedures
213
Surgical Considerations
215
5 Surgical Procedures
216
Equipment and Supplies Required for Implant
217
Preimplant Procedures
219
Implant Procedures
236
Postimplant Procedures
256
Device Explant
261
Patient Care and Management
265
6 Patient Care and Management
266
Postoperative Patient Care
267
Ongoing Patient Assessment and Care
271
Unique Treatment Options and Important Clinical Considerations
274
Using the Shower Bag
278
Using the Stabilization Belt
288
Wearing and Carrying the System Components
291
Preparing for Sleep
326
Ongoing System Assessment and Care
328
Educating and Training Patients, Families, and Caregivers
331
Alarms and Troubleshooting
333
System Controller Alarms
335
7 Alarms and Troubleshooting
336
System Controller Alarms
336
Power Module Alarms
357
Mobile Power Unit Alarms
360
Battery Charger Alarms
362
Guidelines for Power Cable Connectors
365
What Not to Do: Driveline and Cables
366
8 Equipment Storage and Care
374
Cleaning and Maintenance
374
Product Disposal
379
Summary of Clinical Studies
381
Bridge-To-Transplantation (BTT) Study Overview
383
A Summary of Clinical Studies
384
Destination Therapy (DT) Study Overview
400
Post-Approval Studies
426
Post-Approval Overview of Risk of Thrombosis
439
B Technical Specifications
452
C Heartmate II Product List
466
Safety Testing and Classification
473
Safety Testing and Classification
475
D Safety Testing and Classification
476
Testing and Classification: Power Module
483
Testing and Classification: Mobile Power Unit
486
Testing and Classification: Battery Charger
489
Testing and Classification: Heartmate 14 Volt Lithium-Ion Batteries
495
E Symbols
506
Daily Safety Checklist
511
F Safety Checklists
512
Weekly Safety Checklist
513
Monthly Safety Checklist
514
Six Month Safety Checklist
516
Yearly Safety Checklist
518
As-Needed Safety Checklist
519
Clinic Visit Safety Checklist
520
Conversion Patients
521
H Survey
528
Glossary
529
Index
539
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Thoratec HEARTMATE II Patient Handbook (310 pages)
LEFT VENTRICULAR ASSIST SYSTEM
Brand:
Thoratec
| Category:
Medical Equipment
| Size: 34 MB
Table of Contents
Table of Contents
9
1 Introduction
13
Why Reading this Handbook Is Important
15
Understanding Warnings & Cautions
17
General Warnings
18
General Cautions
19
Equipment Overview
20
2 How Your Heart Pump Works
25
Your Heart Pump
27
The Driveline
28
The System Controller
30
System Controller Backup Power
63
The Backup System Controller
65
3 Powering the System
69
Power Overview
71
Using the Mobile Power Unit
72
Using Heartmate 14 Volt Lithium-Ion Batteries
87
Using the Battery Charger
109
Battery Charging Overview
115
Viewing Battery Information on the Battery Charger
119
Calibrating Heartmate 14 Volt Lithium-Ion Batteries
121
4 Living with the Heartmate II
123
Keeping Your Home Safe
125
Staying Active and Safe
126
Hand Washing
126
Eating
128
Showering
129
Caring for the Driveline Exit Site
141
Caring for the Driveline
143
Using the Stabilization Belt
146
Wearing and Carrying the System Controller
150
Sleeping
191
Traveling
193
5 Alarms and Troubleshooting
195
System Controller Alarms
197
Mobile Power Unit Alarms
216
Battery Charger Alarms
218
Guidelines for Power Cable Connectors
223
What Not to Do: Driveline and Cables
224
6 Caring for the Equipment
229
Acceptable Operating Conditions
231
Cleaning and Caring for the Equipment
232
Product Disposal
238
7 Frequently Asked Questions
239
Corporate Information
241
System Use
241
Showers and Exercise
243
Travel
243
8 Handling Emergencies
245
What Is an Emergency
247
9 Testing & Classification
249
Safety Testing and Classification
251
Declaration Concerning General Safety Standards
253
Declaration and Guidance for Electromagnetic Emissions
255
Declaration and Guidance for Electromagnetic Immunity
256
Declaration and Guidance for Electromagnetic Emissions for Heartmate Power Module
262
Declaration and Guidance for Electromagnetic Emissions for the Mobile Power Unit
263
Declaration and Guidance for Electromagnetic Emissions for Battery Charger
264
Declaration and Guidance for Electromagnetic Immunity for the Battery Charger
265
Declaration and Guidance for Electromagnetic Emissions
268
Declaration and Guidance for Electromagnetic Immunity for Heartmate 14 Volt Lithium-Ion Batteries
269
10 Safety Checklists
273
Daily Safety Checklist
275
Weekly Safety Checklist
277
Monthly Safety Checklist
278
Six Month Safety Checklist
280
Yearly Safety Checklist
281
As-Needed Safety Checklist
282
Clinic Visit Safety Checklist
283
11 Survey
285
12 Glossary
289
Abbreviations
291
Terms
292
Thoratec HEARTMATE II Instructions For Use Manual (59 pages)
intermediate-to-chronic left ventricular assist device
Brand:
Thoratec
| Category:
Medical Equipment
| Size: 0 MB
Table of Contents
Field Safety Notice
1
Description of Problem
1
Immediate Action to be Taken
2
Heartmate II LVAS, Implanted and External Components
4
Important Safety Information Update
8
Addendum to the Heartmate II Instructions for Use
12
System Operations
14
System Controller Driveline Connector
14
The Safety Tab Covers the Red Button
14
Connecting the Driveline to the System Controller
15
For the Task You Need
15
To Connect the Driveline to the System Controller
15
For this Task You Need
15
Insert the Driveline into the Socket
16
Disconnecting the Driveline from the System Controller
17
Grasp the Metal End and Remove the Driveline
17
Replacing the Running System Controller with a Backup Controller
18
To Replace the Running System Controller with a Backup Controller
18
Unlock the Safety Tab on the Running System Controller
18
Replace the System Controller
19
Lock the Safety Tab
20
Safety Checklists
22
Weekly Safety Checklist
24
Monthly Safety Checklist
25
Clinic Visit Safety Checklist
27
Conversion Patients
30
Patients Converted from Previous Models of System Controllers
30
Addendum to the Heartmate II LVAS Patient Handbook
37
How Your Heart Pump Works
41
Unlock the Safety Tab
41
Align Arrow on Driveline with Arrow on System Controller
41
Remove Driveline from Socket on System Controller
43
Lock the Safety Tab on the Backup System Controller
47
Safety Checklists
49
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Thoratec HEARTMATE II Pocket Manual (2 pages)
Left Ventricular Assist Device, Alarms for Clinicians
Brand:
Thoratec
| Category:
Medical Equipment
| Size: 0 MB
Table of Contents
Alarms for Clinicians
1
Pump Is off
1
Driveline Is Disconnected
1
Both Power Cables Are Disconnected
1
Low Flow, Flow Is Less than 2.5 Lpm
1
Low Battery, Power Input Is Extremely Low with Less than 5 Min. Remaining
1
One of the Two Power Cables Is Disconnected
2
Low Battery, Power Input Is Low with Less than 15 Min. Remaining
2
System Controller Hardware Fault
2
System Controller Backup Battery Fault
2
Low Speed Advisory Warning
2
Driveline Fault
2
System Controller Backup Battery Not Installed
2
Controller Clock Not Set
2
Thoratec HEARTMATE II Replacing Manual (2 pages)
Replacing the Running System Controller with the Backup Controller for Patients and Their Caregivers
Brand:
Thoratec
| Category:
Medical Equipment
| Size: 0 MB
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