Technical Documents

 

 

OPTIMIZER® Smart Mini System IFUs and Patient Manuals

 

OPTIMIZER® Smart Mini IPG Instructions For Use (Vesta Charger)
Part Number:
  13-290-011-US
Revision Number: 03
Effective Date: 27-April-2022

OPTIMIZER® Smart Mini IPG Instructions For Use (Guardio Charger)
Part Number:
 13-290-015-US
Revision Number: 01
Effective Date:15-August-2023

Previous Revisions

OPTIMIZER® Smart Mini IPG Instructions For Use (Guardio Charger)
Part Number:
 13-290-015-US
Revision Number: 00
Effective Date: 11-November-2022

MRI Safety Information Leaflet for OPTIMIZER® Smart Mini IPG
Part Number:
  13-290-014-US
Revision Number: 02
Effective Date: 31-October-2023

OPTIMIZER® Smart Mini System Patient’s Manual (Vesta Charger – Rev A)
Part Number:  13-250-004-US
Revision Number: 03
Efective Date: 31-October-2023

OPTIMIZER® Smart Mini System Patient’s Manual (Guardio Charger)
Part Number:
  13-250-005-US
Revision Number: 02
Effective Date: 31-October-2023

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

Intelio Programmer System and Guardio Charger System Instructions for Use
Part Number:
13-290-016-US
Revision Number: 00
Effective Date: 11-November-2022

AIM HIGHer Clinical Trial: OPTIMIZER® Smart Mini System IFUs and Patient Manuals

OPTIMIZER® Smart Mini System IPG IFU (Vesta Charger)
Part Number: 12-290-003-US
Revision Number: 02
Effective Date: 30-November-2022
Previous Revisions
OPTIMIZER® Smart Mini System IPG IFU (Vesta Charger)
Part Number: 12-290-003-US
Revision Number: 00
Effective Date: 25-January-2022
OPTIMIZER® Smart Mini IPG IFU for the AIM HIGHer Clinical Trial (Guardio Charger)
Part Number: 12-290-008-US
Revision Number: 00
Effective Date: 13-January-2023

MRI Safety Information Leaflet for OPTIMIZER® Smart Mini IPG (Aim HIGHer Clinical Trial)
Part Number: 12-290-013-US
Revision Number: 01
Effective Date: 01-November-2023

OPTIMIZER® Smart Mini System Patient Manual for the AIM HIGHer Clinical Trial (Vesta Charger)
Part Number: 12-250-004-US
Revision Number: 02
Effective Date:  30-November-2022

OPTIMIZER® Smart Mini System Patient Manual for the AIM HIGHer Clinical Trial (Guardio Charger)
Part Number: 12-250-008-US
Revision Number: 02
Effective Date: 03-November-2023

Intelio Programmer System and Vesta Charger System IFU
Part Number: 12-290-004-US
Revision Number: 01
Effective Date: 04-April-2022

Previous Revisions

Intelio Programmer System and Vesta Charger System IFU
Part Number: 12-290-004-US
Revision Number: 00
Effective Date: 25-January-2022

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

Quick Start Guide For Using the Vesta Charger
Part Number: 12-250-006-US
Revision Number: 01
Effective Date: 26-April-2022

INTEGRA-D Clinical Trial: OPTIMIZER® INTEGRA™ CCM-D™ System IFUs and Patient Manuals

OPTIMIZER® INTEGRA™ CCM-D™ IPG IFU
Part Number: 12-290-005-US
Revision Number: 00
Effective Date: 04-April-2023

OPTIMIZER® INTEGRA™ System Patient’s Manual (Guardio Version)
Part Number: 12-250-005-US
Revision Number: 00
Effective Date: 04-April-2023

Guardio Charger for OPTIMIZER® INTEGRA™ CCM-D™ System IFU
Part Number:12-290-011-US
Revision Number: 01
Effective Date: 15-June-2023

Intelio Programmer for OPTIMIZER® INTEGRA™ CCM-D™ System IFU
Part Number: 12-290-010-US
Revision Number: 00
Effective Date: 04-April-2023

 

OPTIMIZER® Smart System (2-Lead Configuration) IFUs and Patient Manuals

 

OPTIMIZER® Smart IPG IFU 2-lead configuration 
Part Number:  13-290-008-01-US
Revision Number: 06
Effective Date: 01-November-2021
Previous Revisions
OPTIMIZER® Smart IPG IFU 2-lead configuration 
Part Number:  13-290-008-01-US
Revision Number: 05
Effective Date: 02-February-2021

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

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

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

MRI Safety Information Card for OPTIMIZER® Smart IPG – US
Part Number:  13-290-013-US
Revision Number: 00
Effective Date: 03-February-2021
OPTIMIZER® Smart System Patient’s Manual 2-lead configuration
Part Number:  13-250-003-01-US
Revision Number: 03
Efective Date: 01-November-2021
Previous Revisions
OPTIMIZER® Smart System Patient’s Manual 2-lead configuration
Part Number:  13-250-003-01-US
Revision Number: 02
Effective Date: 23-September-2020

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU
Part Number: 13-290-009-01-US
Revision Number: 03
Effective Date: 08-September-2022

OPTIMIZER® Smart System (3-Lead Configuration) IFUs and Patient Manuals

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

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

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

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

MRI Safety Information Card for OPTIMIZER® Smart IPG – US
Part Number:  13-290-013-US
Revision Number: 00
Effective Date: 03-February-2021
OPTIMIZER® Smart System Patient’s Manual 3-lead configuration
Part Number:
  13-250-003-US
Revision Number: 04
Effective Date: 01-November-2021
Previous Revisions
OPTIMIZER® Smart System Patient’s Manual 3-lead configuration
Part Number:
  13-250-003-US
Revision Number: 03
Effective Date: 23-September-2020

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU 3-lead configuration 
Part Number:
  13-290-009-US
Revision Number: 03
Effective Date: 08-September-2022