Technical Documents

 

INSTRUCTIONS FOR USE AND PRODUCT MANUALS

 

Arabic

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Arabic 
Part Number: 13-250-003-ar
Revision Number: 07
Effective Date: 18-February-2021

OPTIMIZER Smart System IPG IFU – Arabic
Part Number: 13-290-008-ar
Revision Number: 11
Effective Date: 31-March-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Arabic
Part Number: 13-290-009-ar
Revision Number: 08
Effective Date: 31-March-2021
Model: SMART

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Arabic
Part Number: 13-250-004-ar
Revision Number: 02
Effective Date: 25-May-2022

OPTIMIZER Smart Mini System IPG IFU – Arabic
Part Number: 13-290-011-ar
Revision Number: 01
Effective Date: 25-May-2022

Intelio Programmer System and Vesta Charger System IFU – Arabic
Part Number: 13-290-012-ar
Revision Number: 02
Effective Date: 25-May-2022

Brazil

 

OPTIMIZER Smart

OPTIMIZER Smart System Patient’s Manual – Brazilian (Portuguese)
Part Number: 13-250-003-pt (BR)
Revision Number: 07
Effective Date: 18-February-2021

OPTIMIZER Smart System IPG IFU – Brazilian Portuguese
Part Number: 13-290-008-pt (BR)
Revision Number: 12
Effective Date: 12-November-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Portuguese Brazilian
Part Number: 13-290-009-pt (BR)
Revision Number: 08
Effective Date: 31-March-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Brazilian (Portuguese)
Part Number: 13-290-013-pt (BR)
Revision Number: 00
Effective Date: 12-November-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Brazilian (Portuguese)
Part Number: 13-250-004-pt (BR)
Revision Number: 02
Effective Date: 25-May-2022

OPTIMIZER Smart Mini System IPG IFU – Brazilian (Portuguese)
Part Number: 13-290-011-pt (BR)
Revision Number: 01
Effective Date: 25-May-2022

Intelio Programmer System and Vesta Charger System IFU – Brazilian (Portuguese)
Part Number: 13-290-012-pt (BR)
Revision Number: 02
Effective Date: 25-May-2022

Bulgarian

 

OPTIMIZER Smart

OPTIMIZER Smart System Patient’s Manual – Bulgarian
Part Number: 13-250-003-bg
Revision Number: 07
Effective Date: 01-July-2021

OPTIMIZER Smart System IPG IFU – Bulgarian
Part Number: 13-290-008-bg
Revision Number: 12
Effective Date: 01-July-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Bulgarian
Part Number: 13-290-009-bg
Revision Number: 08
Effective Date: 1-July-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Bulgarian
Part Number: 13-290-013-bg
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Bulgarian
Part Number: 13-250-004-bg
Revision Number: 02
Effective Date: 25-May-2022

OPTIMIZER Smart Mini System IPG IFU – Bulgarian
Part Number: 13-290-011-bg
Revision Number: 02
Effective Date: 28-October-2022

Intelio Programmer System and Vesta Charger System IFU – Bulgarian
Part Number: 13-290-012-bg
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – Bulgarian
Part Number: 13-290-014-bg
Revision Number: 00
Effective Date: 25-Oct-2022

Croatian

 

OPTIMIZER Smart

OPTIMIZER Smart System Patient’s Manual – Croatian
Part Number: 13-250-003-hr
Revision Number: 07
Effective Date: 01-July-2021
OPTIMIZER Smart System IPG IFU – Croatian
Part Number: 13-290-008-hr
Revision Number: 12
Effective Date: 01-July-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Croatian
Part Number: 13-290-009-hr
Revision Number: 08
Effective Date: 1-July-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Croatian
Part Number: 13-290-013-hr
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Croatian
Part Number: 13-250-004-hr
Revision Number: 02
Effective Date: 25-May-2022

OPTIMIZER Smart Mini System IPG IFU – Croatian
Part Number: 13-290-011-hr
Revision Number: 02
Effective Date: 28-October-2022

Intelio Programmer System and Vesta Charger System IFU – Croatian
Part Number: 13-290-012-hr
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – Croatian
Part Number: 13-290-014-hr
Revision Number: 00
Effective Date: 25-Oct-2022

Czech

 

OPTIMIZER Smart

OPTIMIZER Smart System Patient’s Manual – Czech
Part Number: 13-250-003-cs
Revision Number: 07
Effective Date: 18-February-2021

OPTIMIZER Smart System IPG IFU – Czech
Part Number: 13-290-008-cs
Revision Number: 12
Effective Date: 31-March-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Czech
Part Number: 13-290-009-cs
Revision Number: 08
Effective Date: 31-March-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Czech
Part Number: 13-290-013-cs
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual (Vesta Charger – Rev B) – Czech
Part Number: 13-250-008-cs
Revision Number: 01
Effective Date: 17-October-2023

Previous Revisions

OPTIMIZER Smart Mini System Patient’s Manual – Czech
Part Number: 13-250-004-cs
Revision Number: 02
Effective Date: 25-May-2022

OPTIMIZER Smart Mini System IPG IFU – Czech
Part Number: 13-290-011-cs
Revision Number: 02
Effective Date: 28-October-2022

Vesta Charger System (Rev B) for OPTIMIZER Smart Mini System IFU – Czech
Part Number: 13-290-034-cs
Revision Number: 00
Effective Date: 17-October-2023

Intelio Programmer System (Rev A) IFU – Czech
Part Number: 13-290-033-cs
Revision Number: 00
Effective Date: 17-October-2023

Previous Revisions

Intelio Programmer System and Vesta Charger System IFU – Czech
Part Number: 13-290-012-cs
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – Czech
Part Number: 13-290-014-cs
Revision Number: 00
Effective Date: 25-October-2022

Danish

 

OPTIMIZER Smart

OPTIMIZER Smart System Patient’s Manual – Danish
Part Number: 13-250-003-da
Revision Number: 01
Effective Date: 22-December-2017

OPTIMIZER Smart System IPG IFU – Danish
Part Number: 13-290-008-da
Revision Number: 12
Effective Date: 29-March-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Danish
Part Number: 13-290-009-da
Revision Number: 00
Effective Date: 21-December-2017

MRI Safety Information Card for OPTIMIZER Smart IPG – Danish
Part Number: 13-290-013-da
Revision Number: 00
Effective Date: 04-March-2021

Dutch

 

OPTIMIZER Smart

OPTIMIZER® Smart System Patient’s Manual – Dutch
Part Number: 13-250-003-nl
Revision Number: 07
Effective Date: 18-February-2021

OPTIMIZER Smart System IPG IFU – Dutch
Part Number: 13-290-008-nl
Revision Number: 12
Effective Date: 31-March-2021

Previous Revisions

OPTIMIZER Smart IPG IFU – Dutch
Part Number: 13-290-008-nl
Revision Number: 00
Effective Date: 16-November-2017

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Dutch
Part Number: 13-290-009-nl
Revision Number: 08
Effective Date: 31-March-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Dutch
Part Number: 13-290-013-nl
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual (Vesta Charger – Rev B) – Dutch
Part Number: 13-250-008-nl
Revision Number: 01
Effective Date: 17-October-2023

Previous Revisions

OPTIMIZER Smart Mini System Patient’s Manual – Dutch
Part Number: 13-250-004-nl
Revision Number: 02
Effective Date: 25-May-2022

OPTIMIZER Smart Mini System IPG IFU – Dutch
Part Number: 13-290-011-nl
Revision Number: 02
Effective Date: 28-October-2022

Vesta Charger System (Rev B) for OPTIMIZER Smart Mini System IFU – Dutch
Part Number: 13-290-034-nl
Revision Number: 00
Effective Date: 17-October-2023

Intelio Programmer System (Rev A) IFU – Dutch
Part Number: 13-290-033-nl
Revision Number: 00
Effective Date: 17-October-2023

Previous Revisions

Intelio Programmer System and Vesta Charger System Instructions For Use – Dutch
Part Number: 13-290-012-nl
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information-Card for OPTIMIZER Smart Mini IPG – Dutch
Part Number: 13-290-014-nl
Revision Number: 00
Effective Date: 25-October-2022

EU (English)

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – EU (English)
Part Number: 13-250-003-EU
Revision Number: 07
Effective Date: 01-December-2020

Previous Revisions

OPTIMIZER Smart System Patient’s Manual – EU (English)
Part Number: 13-250-003-EU
Revision Number: 06
Effective Date: 23-September-2020

OPTIMIZER Smart System IPG IFU – EU (English)
Part Number: 13-290-008-EU
Revision Number: 12
Effective Date: 03-February-2021

Previous Revisions

OPTIMIZER Smart System IPG IFU – EU (English)
Part Number: 13-290-008-EU
Revision Number: 11
Effective Date: 01-December-2020

OPTIMIZER Smart System IPG IFU – EU (English)
Part Number: 13-290-008-EU
Revision Number: 10
Effective Date: 23-September-2020

OPTIMIZER Smart System IPG IFU – EU (English)
Part Number: 13-290-008-EU
Revision Number: 09
Effective Date: 03-August-2020

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – EU (English)
Part Number: 13-290-009-EU
Revision Number: 08
Effective Date: 01-December-2020

Previous Revisions
OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – EU (English)
Part Number: 13-290-009-EU
Revision Number: 07
Effective Date:23-September-2020

MRI Safety Information Card for OPTIMIZER Smart IPG – EU (English)
Part Number: 13-290-013-EU
Revision Number: 00
Effective Date: 03-February-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual (Vesta Charger – Rev B) – EU (English)
Part Number: 13-250-008-EU
Revision Number: 01
Effective Date: 17-October-2023

Previous Revisions

OPTIMIZER Smart Mini System Patient’s Manual – EU (English)
Part Number: 13-250-004-EU
Revision Number: 02
Effective Date: 06-October-2021

OPTIMIZER Smart Mini System IPG IFU – EU (English)
Part Number: 13-290-011-EU
Revision Number: 02
Effective Date: 12-October-2022

Previous Revisions

OPTIMIZER Smart Mini System IPG IFU – EU (English)
Part Number: 13-290-011-EU
Revision Number: 01
Effective Date: 25-April-2022

Vesta Charger System (Rev B) for OPTIMIZER Smart Mini System IFU – EU (English)
Part Number: 13-290-034-EU
Revision Number: 00
Effective Date: 17-October-2023

Intelio Programmer System (Rev A) IFU – EU (English)
Part Number: 13-290-033-EU
Revision Number: 00
Effective Date: 17-October-2023

Previous Revisions

Intelio Programmer System and Vesta Charger System IFU – EU (English)
Part Number: 13-290-012-EU
Revision Number: 02
Effective Date: 06-October-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – EU (English)
Part Number: 13-290-014-EU
Revision Number: 00
Effective Date: 12-October-2022

 

ODOCOR II Cardiac Contractility Modulation Leads

ODOCOR II Cardiac Contractility Modulation Lead IFU – EU (English)
Part Number: 23-290-001-EU
Revision Number: 04
Effective Date: 26-October-2020
Previous Revisions
ODOCOR II Cardiac Contractility Modulation Lead IFU – EU (English)
Part Number: 23-290-001-EU
Revision Number: 03
Effective Date: 12-August-2020

Estonian

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Estonian
Part Number: 13-250-003-et
Revision Number: 07
Effective Date: 01-July-2021

OPTIMIZER Smart System IPG IFU – Estonian
Part Number: 13-290-008-et
Revision Number: 12
Effective Date: 01-July-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Estonian
Part Number: 13-290-009-et
Revision Number: 08
Effective Date: 1-July-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Estonian
Part Number: 13-290-013-et
Revision Number: 00
Effective Date: 04-March-2021

Finnish

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Finnish
Part Number: 13-250-003-fi
Revision Number: 07
Effective Date: 01-July-2021

OPTIMIZER Smart System IPG IFU – Finnish
Part Number: 13-290-008-fi
Revision Number: 12
Effective Date: 01-July-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Finnish
Part Number: 13-290-009-fi
Revision Number: 08
Effective Date: 1-July-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Finnish
Part Number: 13-290-013-fi
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Finnish
Part Number: 13-250-004-fi
Revision Number: 02
Effective Date: 25-May-2022

OPTIMIZER Smart Mini System IPG IFU – Finnish
Part Number: 13-290-011-fi
Revision Number: 02
Effective Date: 28-October-2022

Intelio Programmer System and Vesta Charger System IFU – Finnish
Part Number: 13-290-012-fi
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – Finnish
Part Number: 13-290-014-fi
Revision Number: 00
Effective Date: 25-October-2022

French

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – French
Part Number: 13-250-003-fr
Revision Number: 07
Effective Date: 18-February-2021

OPTIMIZER Smart System IPG IFU – French
Part Number: 13-290-008-fr
Revision Number: 12
Effective Date: 31-March-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – French
Part Number: 13-290-009-fr
Revision Number: 08
Effective Date: 31-March-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – French
Part Number: 13-290-013-fr
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual (Vesta Charger – Rev B) – French
Part Number: 13-250-008-fr
Revision Number: 01
Effective Date: 17-October-2023

Previous Revisions

OPTIMIZER Smart Mini System Patient’s Manual – French
Part Number: 13-250-004-fr
Revision Number: 02
Effective Date: 25-May-2022

Optimizer Smart Mini System IPG IFU – French
Part Number: 13-290-011-fr
Revision Number: 02
Effective Date: 28-October-2022

Vesta Charger System (Rev B) for OPTIMIZER Smart Mini System IFU – French
Part Number: 13-290-034-fr
Revision Number: 00
Effective Date: 17-October-2023

Intelio Programmer System (Rev A) IFU – French
Part Number: 13-290-033-fr
Revision Number: 00
Effective Date: 17-October-2023

Previous Revisions

Intelio Programmer System and Vesta Charger System IFU – French
Part Number: 13-290-012-fr
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – French
Part Number: 13-290-014-fr
Revision Number: 00
Effective Date: 25-October-2022

German

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – German
Part Number: 13-250-003-de
Revision Number: 07
Effective Date: 20-November-2020

Previous Revisions

OPTIMIZER Smart System Patient’s Manual – German
Part Number: 13-250-003-de
Revision Number: 06
Effective Date: 09-October-2020

OPTIMIZER Smart System IPG IFU – German
Part Number: 13-290-008-de
Revision Number: 12
Effective Date: 29-March-2021

Previous Revisions

OPTIMIZER Smart System IPG IFU – German
Part Number: 13-290-008-de
Revision Number: 11
Effective Date: 20-November-2020

OPTIMIZER Smart System IPG IFU – German
Part Number: 13-290-008-de
Revision Number: 10
Effective Date: 09-October-2020

OPTIMIZER Smart System IPG IFU – German
Part Number: 13-290-008-de
Revision Number: 9
Effective Date: 13-August-2020

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – German
Part Number: 13-290-009-de
Revision Number: 08
Effective Date: 20-November-2020

Previous Revisions

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – German
Part Number: 13-290-009-de
Revision Number: 07
Effective Date: 09-October-2020

MRI Safety Information Card for OPTIMIZER Smart IPG – German
Part Number: 13-290-013-de
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual (Vesta Charger – Rev B) – German
Part Number: 13-250-008-de
Revision Number: 01
Effective Date: 17-October-2023

Previous Revisions

OPTIMIZER Smart Mini System Patient’s Manual – German
Part Number: 13-250-004-de
Revision Number: 02
Effective Date: 10-May-2022

Optimizer Smart Mini System IPG IFU – German
Part Number: 13-290-011-de
Revision Number: 02
Effective Date: 28-October-2022

Vesta Charger System (Rev B) for OPTIMIZER Smart Mini System IFU – German
Part Number: 13-290-034-de
Revision Number: 00
Effective Date: 17-October-2023

Intelio Programmer System (Rev A) IFU – German
Part Number: 13-290-033-de
Revision Number: 00
Effective Date: 17-October-2023

Previous Revisions

Intelio Programmer System and Vesta Charger System IFU – German
Part Number: 13-290-012-de
Revision Number: 02
Effective Date: 10-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – German
Part Number: 13-290-014-de
Revision Number: 00
Effective Date: 25-October-2022

ODOCOR II Cardiac Contractility Modulation Leads

ODOCOR II Cardiac Contractility Modulation Lead IFU – German
Part Number: 23-290-001-de
Revision Number: 04
Effective Date: 20-November-2020

Greek

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Greek
Part Number: 13-250-003-el
Revision Number: 07
Effective Date: 18-February-2021

OPTIMIZER Smart IPG IFU – Greek
Part Number: 13-290-008-el
Revision Number: 12
Effective Date: 31-March-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Greek
Part Number: 13-290-009-el
Revision Number: 08
Effective Date: 31-March-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Greek
Part Number: 13-290-013-el
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual (Vesta Charger – Rev B) – Greek
Part Number: 13-250-008-el
Revision Number: 01
Effective Date: 17-October-2023

Previous Revisions

OPTIMIZER Smart Mini System Patient’s Manual – Greek
Part Number: 13-250-004-el
Revision Number: 02
Effective Date: 25-May-2022

Optimizer Smart Mini System IPG IFU – Greek
Part Number: 13-290-011-el
Revision Number: 02
Effective Date: 28-October-2022

Vesta Charger System (Rev B) for OPTIMIZER Smart Mini System IFU – Greek
Part Number: 13-290-034-el
Revision Number: 00
Effective Date: 17-October-2023

Intelio Programmer System (Rev A) IFU – Greek
Part Number: 13-290-033-el
Revision Number: 00
Effective Date: 17-October-2023

Previous Revisions

Intelio Programmer System and Vesta Charger System IFU – Greek
Part Number: 13-290-012-el
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – Greek
Part Number: 13-290-014-el
Revision Number: 00
Effective Date: 25-October-2022

Hebrew

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Hebrew
Part Number: 13-250-003-he
Revision Number: 01
Effective Date: 10-November-2017

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Hebrew
Part Number: 13-250-004-he
Revision Number: 02
Effective Date: 25-May-2022

OPTIMIZER Smart Mini System IPG IFU – Hebrew
Part Number: 13-290-011-he
Revision Number: 01
Effective Date: 25-May-2022

Intelio Programmer System and Vesta Charger System IFU – Hebrew
Part Number: 13-290-012-he
Revision Number: 02
Effective Date: 25-May-2022

Hungarian

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Hungarian
Part Number: 13-250-003-hu
Revision Number: 07
Effective Date: 27-April-2021

OPTIMIZER Smart System IPG IFU – Hungarian
Part Number: 13-290-008-hu
Revision Number: 12
Effective Date: 27-April-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Hungarian
Part Number: 13-290-009-hu
Revision Number: 08
Effective Date: 27-April-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Hungarian
Part Number: 13-290-013-hu
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Hungarian
Part Number: 13-250-004-hu
Revision Number: 02
Effective Date: 25-May-2022

Optimizer Smart Mini System IPG IFU – Hungarian
Part Number: 13-290-011-hu
Revision Number: 02
Effective Date: 28-October-2022 

Intelio Programmer System and Vesta Charger System IFU – Hungarian
Part Number: 13-290-012-hu
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – Hungarian
Part Number: 13-290-014-hu
Revision Number: 00
Effective Date: 25-October-2022

Italian

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual- Italian
Part Number: 13-250-003-it
Revision Number: 07
Effective Date: 20-November-2020

Previous Revisions

OPTIMIZER Smart System Patient’s Manual- Italian
Part Number: 13-250-003-it
Revision Number: 06
Effective Date: 09-October-2020

OPTIMIZER Smart System IPG IFU – Italian
Part Number: 13-290-008-it
Revision Number: 12
Effective Date: 29-March-2021

Previous Revisions

OPTIMIZER Smart System IPG IFU – Italian
Part Number: 13-290-008-it
Revision Number: 11
Effective Date: 20-November-2020

OPTIMIZER Smart System IPG IFU – Italian
Part Number: 13-290-008-it
Revision Number: 10
Effective Date: 09-October-2020

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Italian
Part Number: 13-290-009-it
Revision Number: 08
Effective Date: 20-November-2020

Previous Revisions

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Italian
Part Number: 13-290-009-it
Revision Number: 07
Effective Date: 09-October-2020

MRI Safety Information Card for OPTIMIZER Smart IPG – Italian
Part Number: 13-290-013-it
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual (Vesta Charger – Rev B) – Italian
Part Number: 13-250-008-it
Revision Number: 01
Effective Date: 17-October-2023

Previous Revisions

OPTIMIZER Smart Mini System Patient’s Manual – Italian
Part Number: 13-250-004-it
Revision Number: 02
Effective Date: 10-May-2022

Optimizer Smart Mini System IPG IFU – Italian
Part Number: 13-290-011-it
Revision Number: 02
Effective Date: 28-October-2022

Vesta Charger System (Rev B) for OPTIMIZER Smart Mini System IFU –Italian
Part Number: 13-290-034-it
Revision Number: 00
Effective Date: 17-October-2023

Intelio Programmer System (Rev A) IFU – Italian
Part Number: 13-290-033-it
Revision Number: 00
Effective Date: 17-October-2023

Previous Revisions

Intelio Programmer System and Vesta Charger System IFU – Italian
Part Number: 13-290-012-it
Revision Number: 02
Effective Date: 10-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – Italian
Part Number: 13-290-014-it
Revision Number: 00
Effective Date: 25-October-2022

ODOCOR II Cardiac Contractility Modulation Leads

ODOCOR II Cardiac Contractility Modulation Lead IFU – Italian
Part Number: 23-290-001-it
Revision Number: 04
Effective Date: 20-November-2020

Latvian

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Latvian
Part Number: 13-250-003-lv
Revision Number: 07
Effective Date: 01-July-2021

OPTIMIZER Smart System IPG IFU – Latvian
Part Number: 13-290-008-lv
Revision Number: 12
Effective Date: 01-July-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Latvian
Part Number: 13-290-009-lv
Revision Number: 08
Effective Date: 1-July-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Latvian
Part Number: 13-290-013-lv
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Latvian
Part Number: 13-250-004-lv
Revision Number: 02
Effective Date: 25-May-2022

Optimizer Smart Mini System IPG IFU – Latvian
Part Number: 13-290-011-lv
Revision Number: 02
Effective Date: 28-October-2022

Intelio Programmer System and Vesta Charger System IFU – Latvian
Part Number: 13-290-012-lv
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – Latvian
Part Number: 13-290-014-lv
Revision Number: 00
Effective Date: 25-October-2022

Lithuanian

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Lithuanian
Part Number: 13-250-003-lt
Revision Number: 07
Effective Date: 01-July-2021

OPTIMIZER Smart System IPG IFU – Lithuanian
Part Number: 13-290-008-lt
Revision Number: 12
Effective Date: 01-July-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Lithuanian
Part Number: 13-290-009-lt
Revision Number: 08
Effective Date: 1-July-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Lithuanian
Part Number: 13-290-013-lt
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Lithuanian
Part Number: 13-250-004-lt
Revision Number: 02
Effective Date: 25-May-2022

Optimizer Smart Mini System IPG IFU – Lithuanian
Part Number: 13-290-011-lt
Revision Number: 02
Effective Date: 28-October-2022

Intelio Programmer System and Vesta Charger System IFU – Lithuanian
Part Number: 13-290-012-lt
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information-Card for OPTIMIZER Smart Mini IPG – Lithuanian
Part Number: 13-290-014-lt
Revision Number: 00
Effective Date: 25-October-2022

Maltese

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Maltese
Part Number: 13-250-003-mt
Revision Number: 07
Effective Date: 01-July-2021

OPTIMIZER Smart System IPG IFU – Maltese
Part Number: 13-290-008-mt
Revision Number: 12
Effective Date: 01-July-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Maltese
Part Number: 13-290-009-mt
Revision Number: 08
Effective Date: 1-July-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Maltese
Part Number: 13-290-013-mt
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Maltese
Part Number: 13-250-004-mt
Revision Number: 02
Effective Date: 25-May-2022

OPTIMIZER Smart Mini System IPG IFU – Maltese
Part Number: 13-290-011-mt
Revision Number: 02
Effective Date: 28-October-2022

Intelio Programmer System and Vesta Charger System IFU – Maltese
Part Number: 13-290-012-mt
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – Maltese
Part Number: 13-290-014-mt
Revision Number: 00
Effective Date: 25-October-2022

Norwegian

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Norwegian
Part Number: 13-250-003-no
Revision Number: 07
Effective Date: 21-December-2017

OPTIMIZER Smart System IPG IFU – Norwegian
Part Number: 13-290-008-no
Revision Number: 00
Effective Date:

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Norwegian

Part Number: 13-290-009-no
Revision Number: 00
Effective Date: 21-December-2017

Polish

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Polish
Part Number: 13-250-003-pl
Revision Number: 07
Effective Date: 01-July-2021

OPTIMIZER Smart System IPG IFU – Polish
Part Number: 13-290-008-pl
Revision Number: 12
Effective Date: 01-July-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Polish
Part Number: 13-290-009-pl
Revision Number: 08
Effective Date: 1-July-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Polish
Part Number: 13-290-013-pl
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Polish
Part Number: 13-250-004-pl
Revision Number: 02
Effective Date: 25-May-2022

OPTIMIZER Smart Mini System IPG IFU – Polish
Part Number: 13-290-011-pl
Revision Number: 02
Effective Date: 28-October-2022

Intelio Programmer System and Vesta Charger System IFU – Polish
Part Number: 13-290-012-pl
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information-Card for OPTIMIZER Smart Mini IPG – Polish
Part Number: 13-290-014-pl
Revision Number: 00
Effective Date: 25-October-2022

Portuguese

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Portuguese
Part Number: 13-250-003-pt (PT)
Revision Number: 07
Effective Date: 20-November-2020
Previous Revisions

OPTIMIZER Smart System Patient’s Manual – Portuguese
Part Number: 13-250-003-PT
Revision Number: 06
Effective Date: 09-October-2020

OPTIMIZER Smart System IPG IFU – Portuguese
Part Number: 13-290-008-pt (PT)
Revision Number: 12
Effective Date: 29-March-2021

Previous Revisions

OPTIMIZER Smart System IPG IFU – Portuguese
Part Number: 13-290-008-pt
Revision Number: 11
Effective Date: 20-November-2020

OPTIMIZER Smart System IPG IFU – Portuguese
Part Number: 13-290-008-pt
Revision Number: 10  (Initial version)
Effective Date: 09-October-2020

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Portuguese
Part Number: 13-290-009-pt (PT)
Revision Number: 08
Effective Date: 20-November-2020

Previous Revisions

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Portuguese
Part Number: 13-290-009-pt
Revision Number: 07 (Initial version)
Effective Date: 09-October-2020

MRI Safety Information Card for OPTIMIZER Smart IPG – Portuguese
Part Number: 13-290-013-pt (PT)
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual (Vesta Charger – Rev B) – Portuguese
Part Number: 13-250-008-(PT)
Revision Number: 01
Effective Date: 17-October-2023

Previous Revisions

OPTIMIZER Smart Mini System Patient’s Manual – Portuguese
Part Number: 13-250-004-(PT)
Revision Number: 02
Effective Date: 25-May-2022

OPTIMIZER Smart Mini System IPG IFU – Portuguese
Part Number: 13-290-011-(PT)
Revision Number: 02
Effective Date: 28-October-2022

Vesta Charger System (Rev B) for OPTIMIZER Smart Mini System IFU – Portuguese
Part Number: 13-290-034-(PT)
Revision Number: 00
Effective Date: 17-October-2023

Intelio Programmer System (Rev A) IFU – Portuguese
Part Number: 13-290-033-(PT)
Revision Number: 00
Effective Date: 17-October-2023

Previous Revisions

Intelio Programmer System and Vesta Charger System IFU – Portuguese
Part Number: 13-290-012-(PT)
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – Portuguese
Part Number: 13-290-014-(PT)
Revision Number: 00
Effective Date: 25-October-2022

Romanian

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Romanian
Part Number: 13-250-003-ro
Revision Number: 07
Effective Date: 01-July-2021

OPTIMIZER Smart System IPG IFU – Romanian
Part Number: 13-290-008-ro
Revision Number: 12
Effective Date: 01-July-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Romanian
Part Number: 13-290-009-ro
Revision Number: 08
Effective Date: 1-July-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Romanian
Part Number: 13-290-013-ro
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Romanian
Part Number: 13-250-004-ro
Revision Number: 02
Effective Date: 28-May-2022

OPTIMIZER Smart Mini System IPG IFU – Romanian
Part Number: 13-290-011-ro
Revision Number: 02
Effective Date: 28-October-2022

Intelio Programmer System and Vesta Charger System IFU – Romanian
Part Number: 13-290-012-ro
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – Romanian
Part Number: 13-290-014-ro
Revision Number: 00
Effective Date: 25-October-2022

Russian

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Russian
Part Number: 13-250-003-ru
Revision Number: 07
Effective Date: 20-November-2020

Previous Revisions

OPTIMIZER Smart System Patient’s Manual – Russian
Part Number: 13-250-003-RU
Revision Number: 06
Effective Date: 09-October-2020

OPTIMIZER Smart System IPG IFU – Russian
Part Number: 13-290-008-ru
Revision Number: 11
Effective Date: 20-November-2020

Previous Revisions

OPTIMIZER Smart System IPG IFU – Russian
Part Number: 13-290-008-ru
Revision Number: 10 (Initial version)
Effective Date: 09-October-2020

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Russian
Part Number: 13-290-009-ru
Revision Number: 08
Effective Date: 20-November-2020

Previous Revisions

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Russian
Part Number: 13-290-009-ru
Revision Number: 07
Effective Date: 09-October-2020

MRI Safety Information Card for OPTIMIZER Smart IPG – Russian
Part Number: 13-290-013-ru
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual (Vesta Charger – Rev B) – Russian
Part Number: 13-250-008-ru
Revision Number: 01
Effective Date: 9-October-2023

Previous Revisions

OPTIMIZER Smart Mini System Patient’s Manual – Russian
Part Number: 13-250-004-ru
Revision Number: 02
Effective Date: 25-May-2022

OPTIMIZER Smart Mini System IPG IFU – Russian
Part Number: 13-290-011-ru
Revision Number: 01
Effective Date: 25-May-2022

Intelio Programmer System and Vesta Charger System IFU – Russian
Part Number: 13-290-012-ru
Revision Number: 02
Effective Date: 25-May-2022

Serbian

 

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Serbian
Part Number: 13-250-004-sr
Revision Number: 02
Effective Date: 25-July-2022

OPTIMIZER Smart Mini System IPG IFU- Serbian
Part Number: 13-290-011-sr
Revision Number: 01
Effective Date: 25-July-2022

Intelio Programmer System and Vesta Charger System IFU – Serbian
Part Number: 13-290-012-sr
Revision Number: 02
Effective Date: 25-July-2022

Slovak

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Slovak
Part Number: 13-250-003-sk
Revision Number: 07
Effective Date: 01-July-2021
OPTIMIZER Smart System IPG IFU – Slovak
Part Number: 13-290-008-sk
Revision Number: 12
Effective Date: 01-July-2021
OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Slovak
Part Number: 13-290-009-sk
Revision Number: 08
Effective Date: 1-July-2021
MRI Safety Information Card for OPTIMIZER Smart IPG – Slovak
Part Number: 13-290-013-sk
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System IPG IFU – Slovak
Part Number: 13-290-011-sk
Revision Number: 02
Effective Date: 28-October-2022

OPTIMIZER Smart Mini System Patient’s Manual – Slovak
Part Number: 13-250-004-sk
Revision Number: 02
Effective Date: 25-May-2022
Intelio Programmer System and Vesta Charger System IFU – Slovak
Part Number: 13-290-012-sk
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information-Card for OPTIMIZER Smart Mini IPG – Slovak
Part Number: 13-290-014-sk
Revision Number: 00
Effective Date: 25-October-2022

Slovenian

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Slovenian
Part Number: 13-250-003-sl
Revision Number: 07
Effective Date: 01-July-2021

OPTIMIZER Smart System IPG IFU – Slovenian
Part Number: 13-290-008-sl
Revision Number: 12
Effective Date: 01-July-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Slovenian
Part Number: 13-290-009-sl
Revision Number: 08
Effective Date: 1-July-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Slovenian
Part Number: 13-290-013-sl
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Slovenian
Part Number: 13-250-004-sl
Revision Number: 02
Effective Date: 25-May-2022

OPTIMIZER Smart Mini System IPG IFU – Slovenian
Part Number: 13-290-011-sl
Revision Number: 02
Effective Date: 28-October-2022

Intelio Programmer System and Vesta Charger System IFU – Slovenian
Part Number: 13-290-012-sl
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – Slovenian
Part Number: 13-290-014-sl
Revision Number: 00
Effective Date: 25-October-2022

Spanish

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Spanish
Part Number: 13-250-003-es
Revision Number: 07
Effective Date: 20-November-2020

Previous Revisions

OPTIMIZER Smart System Patient’s Manual – Spanish
Part Number: 13-250-003-SP
Revision Number: 06
Effective Date: 09-October-2020

OPTIMIZER Smart System Patient’s Manual – Spanish
Part Number: 13-250-003-SP
Revision Number: 05
Effective Date: 13-August-2020

OPTIMIZER Smart System IPG IFU – Spanish
Part Number: 13-290-008-es
Revision Number: 12
Effective Date: 29-March-2021

Previous Revision

OPTIMIZER Smart System IPG IFU – Spanish
Part Number: 13-290-008-es
Revision Number: 11
Effective Date: 20-November-2020

OPTIMIZER Smart System IPG IFU – Spanish
Part Number: 13-290-008-es
Revision Number: 10
Effective Date: 09-October-2020

OPTIMIZER Smart System IPG IFU – Spanish
Part Number: 13-290-008-es
Revision Number: 9
Effective Date: 13-August-2020

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Spanish
Part Number: 13-290-009-es
Revision Number: 08
Effective Date: 20-November-2020

Previous Revisions

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Spanish
Part Number: 13-290-009-es
Revision Number: 07
Effective Date: 09-October-2020

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Spanish
Part Number: 13-290-009-es
Revision Number: 06 (Initial version)
Effective Date: 13-August-2020

MRI Safety Information Card for OPTIMIZER Smart IPG – Spanish
Part Number: 13-290-013-es
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual (Vesta Charger – Rev B) – Spanish
Part Number: 13-250-008-es
Revision Number: 01
Effective Date: 17-October-2023

Previous Revisions

OPTIMIZER Smart Mini System Patient’s Manual – Spanish
Part Number: 13-250-004-es
Revision Number: 02
Effective Date: 10-May-2022

OPTIMIZER Smart Mini System IPG IFU – Spanish
Part Number: 13-290-011-es
Revision Number: 02
Effective Date: 28-October-2022

Vesta Charger System (Rev B) for OPTIMIZER Smart Mini System IFU – Spanish
Part Number: 13-290-034-es
Revision Number: 00
Effective Date: 17-October-2023

Intelio Programmer System (Rev A) IFU – Spanish
Part Number: 13-290-033-es
Revision Number: 00
Effective Date: 17-October-2023

Previous Revisions

Intelio Programmer System and Vesta Charger System IFU – Spanish
Part Number: 13-290-012-es
Revision Number: 02
Effective Date: 10-May-2022

MRI Safety Information Card for OPTIMIZER Smart Mini IPG – Spanish
Part Number: 13-290-014-es
Revision Number: 00
Effective Date: 25-October-2022

ODOCOR II Cardiac Contractility Modulation Leads

ODOCOR II Cardiac Contractility Modulation Lead IFU – Spanish
Part Number: 23-290-001-es
Revision Number: 04
Effective Date: 20-November-2020

Swedish

 

OPTIMIZER Smart System

OPTIMIZER Smart System Patient’s Manual – Swedish
Part Number: 13-250-003-sv
Revision Number: 07
Effective Date: 01-July-2021

OPTIMIZER Smart System IPG IFU – Swedish
Part Number: 13-290-008-sv
Revision Number: 12
Effective Date: 01-July-2021

OMNI II Programmer (with OMNI Smart SW) System and OPT Mini Charger IFU – Swedish
Part Number: 13-290-009-sv
Revision Number: 08
Effective Date: 1-July-2021

MRI Safety Information Card for OPTIMIZER Smart IPG – Swedish
Part Number: 13-290-013-sv
Revision Number: 00
Effective Date: 04-March-2021

OPTIMIZER Smart Mini System

OPTIMIZER Smart Mini System Patient’s Manual – Swedish
Part Number: 13-250-004-sv
Revision Number: 02
Effective Date: 25-May-2022

Optimizer Smart Mini IPG IFU – Swedish
Part Number: 13-290-011-sv
Revision Number: 02
Effective Date: 28-October-2022

Intelio Programmer System and Vesta Charger System IFU – Swedish
Part Number: 13-290-012-sv
Revision Number: 02
Effective Date: 25-May-2022

MRI Safety Information-Card for OPTIMIZER Smart Mini IPG – Swedish
Part Number: 13-290-014-sv
Revision Number: 00
Effective Date: 25-October-2022

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