Technical Documents

 

 

OPTIMIZER SMART SYSTEM (2-Lead Configuration) IFUs and Patient Manual

 

OPTIMIZER Smart IPG IFU
Part Number:  13-290-008-01-US
Revision Number: 06
Effective Date: 01-November-2021
Model: SMART 2-lead configuration 

Previous Revisions

OPTIMIZER Smart IPG IFU
Part Number:  13-290-008-01-US
Revision Number: 05
Effective Date: 02-February-2021
Model: SMART 2-lead configuration 

OPTIMIZER Smart IPG IFU
Part Number:  13-290-008-01-US
Revision Number: 04
Effective Date: 05-November-2020
Model: SMART 2-lead configuration 

OPTIMIZER Smart IPG IFU
Part Number:  13-290-008-01-US
Revision Number: 03
Effective Date: 23-September-2020
Model: SMART 2-lead configuration 

OPTIMIZER Smart IPG IFU
Part Number:  13-290-008-01-US
Revision Number: 02
Effective Date: 03-August-2020
Model: SMART 2-lead configuration 

MRI Safety Information Card for OPTIMIZER Smart IPG – US
Part Number:  13-290-013-US
Revision Number: 00
Effective Date: 03-February-2021
Model: SMART

OPTIMIZER Smart System Patient’s Manual
Part Number:  13-250-003-01-US
Revision Number: 03
Efective Date: 01-November-2021
Model: SMART 2-lead configuration
Previous Revisions
OPTIMIZER Smart System Patient’s Manual
Part Number:  13-250-003-01-US
Revision Number: 02
Effective Date: 23-September-2020
Model: SMART 2-lead configuration
 

OPTIMIZER Smart Mini System IFUs and Manuals

 

OPTIMIZER Smart Mini System Patient’s Manual
Part Number:  13-250-004-US
Revision Number: 02
Efective Date: 27-April-2022
Model: Smart Mini

MRI Safety Information Leaflet for OPTIMIZER Smart Mini IPG
Part Number:  13-290-014-US
Revision Number: 01
Effective Date: 27-April-2022
Model: Smart Mini

OPTIMIZER Smart Mini IPG Instructions For Use
Part Number:  13-290-011-US
Revision Number: 03
Effective Date: 27-April-2022
Model: Smart Mini

Intelio Programmer System and Vesta Charger System Instructions For Use
Part Number:  13-290-012-US
Revision Number: 00
Effective Date: 06-October-2021
Model: Smart Mini

AIM HIGHer Clinical Trial: IFUs and Manuals for the OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient Manual for the AIM HIGHer Clinical Trial
Part Number: 12-250-004-US
Revision Number: 02
Effective Date:  30-November-2022
Model: OPTIMIZER® Smart Mini Implantable Pulse Generator

OSM – Implanted Medical Device ID Card for the AIM HIGHer Clinical Study
Part Number: 12-270-004-US
Revision Number: 01
Effective Date: 26-April-2022
Model: OPTIMIZER® Smart Mini Implantable Pulse Generator
OPTIMIZER™ Smart Mini System IPG IFU
Part Number: 12-290-003-US
Revision Number: 02
Effective Date: 30-November-2022
Model: OPTIMIZER® Smart Mini Implantable Pulse Generator
Previous Revisions
OPTIMIZER™ Smart Mini System IPG IFU
Part Number: 12-290-003-US
Revision Number: 00
Effective Date: 25-January-2022
Model: OPTIMIZER® Smart Mini Implantable Pulse Generator
Intelio Programmer System and Vesta Charger System IFU
Part Number: 12-290-004-US
Revision Number: 01
Effective Date: 04-April-2022
Model: OPTIMIZER® Smart Mini Implantable Pulse Generator
Previous Revisions
Intelio Programmer System and Vesta Charger System IFU
Part Number: 12-290-004-US
Revision Number: 00
Effective Date: 25-January-2022
Model: OPTIMIZER® Smart Mini Implantable Pulse Generator

Quick Start Guide For Using the Vesta Charger
Part Number: 12-250-006-US
Revision Number: 01
Effective Date: 26-April-2022
Model: OPTIMIZER® Smart Mini Implantable Pulse Generator

MRI Safety Information Leaflet for OPTIMIZER Smart Mini IPG (Aim HIGHer Clinical Trial)
Part Number: 12-290-013-US
Revision Number: 00
Effective Date: 30-November-2022
Model: OPTIMIZER® Smart Mini Implantable Pulse Generator

OPTIMIZER Smart Mini System Patient’s Manual for the AIM HIGHer Clinical Trial
Part Number: 12-250-008-US
Revision Number: 00
Effective Date: 13-January-2023
Model: OPTIMIZER® Smart Mini Implantable Pulse Generator
OPTIMIZER Smart Mini IPG IFU for the AIM HIGHer Clinical Trial
Part Number: 12-290-008-US
Revision Number: 00
Effective Date: 13-January-2023
Model: OPTIMIZER® Smart Mini Implantable Pulse Generator
Intelio Programmer and Guardio Charger IFU for AIM HIGHer Clinical Trial
Part Number: 12-290-009-US
Revision Number: 00
Effective Date: 13-January-2023
Model: OPTIMIZER® Smart Mini Implantable Pulse Generator
OSM System Electronic IFU Information Card for AIM HIGHer – US
Part Number: 12-290-007-US
Revision Number: 01
Effective Date: 13-January-2023
Model: OPTIMIZER® Smart Mini Implantable Pulse Generator

OPTIMIZER SMART SYSTEM (3-Lead Configuration) IFUs and Patient Manual

OPTIMIZER Smart IPG IFU
Part Number:  13-290-008-US
Revision Number: 06
Effective Date: 01-November-2021
Model: SMART 3-lead configuration

Previous Revisions
OPTIMIZER Smart IPG IFU
Part Number:  13-290-008-US
Revision Number: 05
Effective Date: 15-January-2021
Model: SMART 3-lead configuration

OPTIMIZER Smart IPG IFU
Part Number:  13-290-008-US
Revision Number: 04
Effective Date: 23-September-2020
Model: SMART 3-lead configuration

OPTIMIZER Smart IPG IFU
Part Number:  13-290-008-US
Revision Number: 03
Effective Date: 03-August-2020
Model: SMART 3-lead configuration

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU
Part Number:  13-290-009-US
Revision Number: 03
Effective Date: 23-September-2020
Model: SMART 3-lead configuration

OPTIMIZER Smart System Patient’s Manual
Part Number:  13-250-003-US
Revision Number: 04
Effective Date: 01-November-2021
Model: SMART 3-lead configuration
Previous Revisions
OPTIMIZER Smart System Patient’s Manual
Part Number:  13-250-003-US
Revision Number: 03
Effective Date: 23-September-2020
Model: SMART 3-lead configuration

© 2023 Impulse Dynamics   Terms of Use | Data Protection | Vulnerability Disclosure  | Terms and Conditions