Bolder Surgical CoolSeal GENERATOR User manual

Bolder Surgical CoolSeal™ Generator
For use with software version 1.X.X
User’s Guide
CoolSeal™Generator
REF CSL-200-50
GENERATOR
en – User’s Guide
da – Brugsanvisning
de– Gebrauchsanweisung
el – Οδηγίες χρήσης
es – Instrucciones de uso
 – Käyttöohjeet
fr – Mode d’emploi
is – Notkunarleiðbeiningar
it – Istruzioni per l’uso
nl – Gebruiksaanwijzing
no – Bruksanvisning
pt – Instruções de utilização
ro – Ghidul utilizatorului
sv – Bruksanvisning
tr – Kullanıcı Kılavuzu
Bolder Surgical
Made in USA. Printed in USA.
© 2021 Bolder Surgical
All rights reserved.
www.BolderSurgical.com
Tel: [phone]
Patent Information
www.BolderSurgical.com/patents
ICE-DO-18103 Rev. F
Issue Date: 2021-09-30
www.BolderSurgical.com/IFUs
Bolder Surgical
331 S. 104th Street, Suite 200
Louisville, CO 80027
USA
2797
GENERATOR
Generator User's Guide

Bolder Surgical Bolder SurgicalCoolSeal™ Generator CoolSeal™ Generator

Bolder Surgical en - CoolSeal™ Generator
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Table of Contents
Preface.......................................................................................................................................................................................................4
Equipment covered in this manual ......................................................................................................................... 4
Patent Information:............................................................................................................................................................ 4
Trademark acknowledgements ................................................................................................................................. 4
Manufactured by: ............................................................................................................................................................... 4
For information call............................................................................................................................................................ 4
Conventions Used in this Guide................................................................................................................. 4
Chapter 1. Overview and General Features.........................................................................5
Introduction ..................................................................................................................................................... 5
Indication for Use............................................................................................................................................ 5
Contraindications for Use............................................................................................................................ 5
Front Panel........................................................................................................................................................ 6
Rear Panel.......................................................................................................................................................... 6
Bottom View..................................................................................................................................................... 7
List of Accessories........................................................................................................................................... 7
Compatible Vessel-Sealing Instruments................................................................................................. 7
Chapter 2. Patient and Operating Room Safety...................................................................8
Warnings and Cautions .............................................................................................................................. 8
Overview.................................................................................................................................................................................. 8
Generator Setup Safety................................................................................................................................................... 8
Electromagnetic Compatibility.................................................................................................................................. 9
Fire Hazard During Oropharyngeal Surgery....................................................................................................... 9
Pacemakers and ICDs ...................................................................................................................................................... 9
Connecting a CoolSeal™Instrument.....................................................................................................................10
Cleaning the CoolSeal™Generator.........................................................................................................................10
Servicing the CoolSeal™Generator ........................................................................................................................10
Chapter 3. Setup and Use of the CoolSeal™Generator......................................................11
Unpacking the CoolSeal™Generator....................................................................................................11
Inspecting the CoolSeal™Generator.....................................................................................................11
Setup Safety..................................................................................................................................................11
Setting up the CoolSeal™Generator.....................................................................................................12
Adjusting the volume................................................................................................................................13

Bolder Surgical en - CoolSeal™ Generator
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Connecting a CoolSeal™Instrument.....................................................................................................13
Connecting a CoolSeal™Instrument to the CoolSeal™Generator..............................................13
Activating a CoolSeal™Instrument........................................................................................................13
Descriptions of Alert Conditions ...........................................................................................................14
Chapter 4. After Surgery ....................................................................................................17
Turning O the CoolSeal™Generator...................................................................................................17
Preparing the CoolSeal™Generator for Reuse...................................................................................17
Chapter 5. Troubleshooting.................................................................................................18
General Troubleshooting Guidelines...................................................................................................18
Correcting Malfunctions...........................................................................................................................18
Abnormal Patient Response.......................................................................................................................................18
CoolSeal™Generator Malfunctions.........................................................................................................................18
Potential interactions with other device ............................................................................................................20
Chapter 6. Periodic Functional Testing, Maintenance and Service..................................21
Responsibility of the Manufacturer......................................................................................................21
Periodic Functional Testing and Maintenance .................................................................................21
When should Periodic Functional Testing be performed?......................................................................21
When must the power cord be replaced?.........................................................................................................21
When should the fuses be replaced?...................................................................................................................21
How can the fuses be replaced?..............................................................................................................................21
Product Service............................................................................................................................................22
Returning the CoolSeal™Generator for Service..............................................................................................22
Software Upgrades ....................................................................................................................................22
Chapter 7. Technical Specications.....................................................................................23
Performance Characteristics...................................................................................................................23
General....................................................................................................................................................................................23
Dimensions and Weight...............................................................................................................................................23
Operating Parameters ...................................................................................................................................................23
Transport and Storage...................................................................................................................................................23
Internal Memory................................................................................................................................................................23
Activation Tone ..................................................................................................................................................................24
Alert Tones ............................................................................................................................................................................24
Input Power..........................................................................................................................................................................24
Power Cord Specication ............................................................................................................................................24

Bolder Surgical en - CoolSeal™ Generator
Page | 3
Technical Specications ...........................................................................................................................25
Input Frequency.................................................................................................................................................................25
Input Current ......................................................................................................................................................................25
Backup Power......................................................................................................................................................................25
Equipotential Connection ...........................................................................................................................................25
Duty Cycle .............................................................................................................................................................................25
Low Frequency (50/60 Hz) Leakage Current....................................................................................................25
Standards and IEC Classications............................................................................................................................25
Symbols..........................................................................................................................................................26
Classications...............................................................................................................................................27
Class I Equipment (IEC 60601-1)..............................................................................................................................27
Electromagnetic Compatibility (IEC 60601-1-2).............................................................................................27
Type CF Equipment (IEC 60601-1)..........................................................................................................................27
IP XX Liquid Ingress/Spillage (IEC 60601-1 and IEC 60601-2-2)............................................................27
Voltage Transients – Energy Platform Mains Transfer (IEC60601-1 and IEC 60601-2-2).........27
Electromagnetic Compatibility (IEC 60601-1-2 and IEC60601-2-2)...................................................27
Output Characteristics..............................................................................................................................27
Maximum Output for the CoolSeal™Generator.............................................................................................27
Electromagnetic Immunity.........................................................................................................................................28
Appendix A – Periodic Functional Test ...............................................................................32
Denitions .............................................................................................................................................................................32
Equipment Required:......................................................................................................................................................32
Pass/Fail Criteria:.................................................................................................................................................................32
Procedure: .............................................................................................................................................................................33
Periodic Functional Test Summary Form................................................................................................................36
Warranty................................................................................................................................38