Technical Documents

 

INSTRUCTIONS FOR USE AND PRODUCT MANUALS

 

EU (English)

 

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

Previous Revisions

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

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

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

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
Model: SMART

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
Model: SMART

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

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

ODOCOR II Cardiac Contractility Modulation Lead Instructions for Use
Part Number: 23-290-001-EU
Revision Number: 04
Effective Date: 26-October-2020
Model: SMART

Previous Revisions
ODOCOR II Cardiac Contractility Modulation Lead Instructions for Use
Part Number: 23-290-001-EU
Revision Number: 03
Effective Date: 12-August-2020
Model: SMART

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

OPTIMIZER Smart Patient ID card- EU (English)
Part Number: 13-270-003-eu
Revision Number: 02
Effective Date: 01-December-2020
Model: SMART

German

 

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

Previous Revisions

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

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

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

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

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

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
Model: SMART

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
Model: SMART

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

Italian

 

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

Previous Revisions

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

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
Model: SMART

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
Model: SMART

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

Previous Revisions

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

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

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

Greek

 

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

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

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
Model: SMART

OPTIMIZER Smart Patient ID card- Greek
Part Number: 13-270-003-el
Revision Number: 02
Effective Date: 01-December-2020
Model: SMART
OPTIMIZER Smart Electronic IFU Information Card – Greek
Part Number: 13-290-010-el
Revision Number: 03
Effective Date: 31-March-2021
Model: SMART

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

Danish

 

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

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

OPTIMIZER Smart Patient ID Card – Danish
Part Number: 13-270-003-da
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART

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

OPTIMIZER Smart System Patient’s Manual – Danish
Part Number: 13-250-003-da
Revision Number: 08
Effective Date: 05-April-2021
Model: SMART

OPTIMIZER Smart System Patient’s Manual – Danish
Part Number: 13-250-003-da
Revision Number: 08
Effective Date: 05-April-2021
Model: SMART

French

 

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

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

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
Model: SMART

OPTIMIZER Smart Patient ID Card – French
Part Number: 13-270-003-fr
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART

OPTIMIZER Smart Electronic IFU Information Card – French
Part Number: 13-290-010-fr
Revision Number: 03
Effective Date: 31-March-2021
Model: SMART

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

Dutch

 

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

Previous Revisions

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

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

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
Model: SMART

OPTIMIZER Smart Patient ID Card – Dutch
Part Number: 13-270-003-nl
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART

OPTIMIZER Smart Electronic IFU Information Card – Dutch
Part Number: 13-290-010-nl
Revision Number: 03
Effective Date: 31-March-2021
Model: SMART

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

Arabic

 

OPTIMIZER Smart System Patient’s Manual – Arabic (Egypt)
Part Number: 13-250-003-AR
Revision Number: 07
Effective Date: 18-February-2021
Model: SMART

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

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 Patient ID Card – Arabic
Part Number: 13-270-003-ar
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART

OPTIMIZER Smart Electronic IFU Information Card – Arabic
Part Number: 13-290-010-ar
Revision Number: 03
Effective Date: 31-March-2021
Model: SMART

Czech

 

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

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

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
Model: SMART

OPTIMIZER Smart Patient ID Card – Czech
Part Number: 13-270-003-cs
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART

OPTIMIZER Smart Electronic IFU Information Card – Czech
Part Number: 13-290-010-cs
Revision Number: 03
Effective Date: 31-March-2021
Model: SMART

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

Brazil

 

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

OPTIMIZER Smart IPG IFU – Brazilian Portuguese
Part Number: 13-290-008-pt (BR)
Revision Number: 11
Effective Date: 31-March-2021
Model: SMART

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
Model: SMART

OPTIMIZER Smart Patient ID Card – Portuguese Brazilian
Part Number: 13-270-003-pt (BR)
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART

Portuguese

 

OPTIMIZER Smart System Patient’s Manual – Portuguese
Part Number: 13-250-003-PT
Revision Number: 07
Effective Date: 20-November-2020
Model: SMART

Previous Revisions

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

OPTIMIZER Smart IPG IFU – Portuguese
Part Number: 13-290-008-pt
Revision Number: 12
Effective Date: 29-March-2021
Model: SMART

Previous Revisions

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

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

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
Model: SMART
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
Model: SMART

OPTIMIZER Smart Electronic IFU Information Card – Portuguese
Part Number: 13-290-010-pt (PT)
Revision Number: 03
Effective Date: 31-March-2021
Model: SMART

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

OPTIMIZER Smart System Patient’s Manual – Portuguese
Part Number: 13-250-003-pt
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Russian

 

OPTIMIZER Smart System Patient’s Manual – Russian
Part Number: 13-250-003-ru
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Previous Revisions

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

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

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

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
Model: SMART

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
Model: SMART

OPTIMIZER Smart Electronic IFU Information Card – Russian
Part Number: 13-290-010-ru
Revision Number: 03
Effective Date: 31-March-2021
Model: SMART

Romanian

 

OPTIMIZER Smart Patient ID Card – Romanian
Part Number: 13-270-003-ro
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART
MRI Safety Information Card for OPTIMIZER Smart IPG – Romanian
Part Number: 13-290-013-ro
Revision Number: 00
Effective Date: 03-February-2021
Model: SMART

OPTIMIZER Smart System Patient’s Manual – Romanian
Part Number: 13-250-003-ro
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Bulgarian

 

OPTIMIZER Smart Patient ID Card – Bulgarian
Part Number: 13-270-003-bg
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART

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

Finnish

 

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

OPTIMIZER Smart System Patient’s Manual – Finnish
Part Number: 13-250-003-fi
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Polish

 

MRI Safety Information Card for OPTIMIZER Smart IPG – Polish
Part Number: 13-290-013-pl
Revision Number: 00
Effective Date: 03-February-2021
Model: SMART
OPTIMIZER Smart System Patient’s Manual – Polish
Part Number: 13-250-003-pl
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Latvian

 

MRI Safety Information Card for OPTIMIZER Smart IPG – Latvian
Part Number: 13-290-013-lv
Revision Number: 00
Effective Date: 03-February-2021
Model: SMART
OPTIMIZER Smart System Patient’s Manual – Latvian
Part Number: 13-250-003-lv
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Swedish

 

MRI Safety Information Card for OPTIMIZER Smart IPG – Swedish
Part Number: 13-290-013-sv
Revision Number: 00
Effective Date: 03-February-2021
Model: SMART
OPTIMIZER Smart System Patient’s Manual – Swedish
Part Number: 13-250-003-sv
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Traditional Chinese

 

OPTIMIZER Smart System Patient’s Manual – Traditional Chinese
Part Number: 13-250-003-zh
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Turkish

 

OPTIMIZER Smart System Patient’s Manual – Turkish
Part Number: 13-250-003-tr
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Hebrew

 

OPTIMIZER Smart System Patient’s Manual – Hebrew
Part Number: 13-250-003-he
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Norwegian

 

OPTIMIZER Smart System Patient’s Manual – Norwegian
Part Number: 13-250-003-no
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Traditional Chinese

 

OPTIMIZER Smart System Patient’s Manual – Traditional Chinese
Part Number: 13-250-003-zh
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Slovenian

 

OPTIMIZER Smart Patient ID Card – Slovenian
Part Number: 13-270-003-sl
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART

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

OPTIMIZER Smart System Patient’s Manual – Slovenian
Part Number: 13-250-003-sl
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Maltese

 

OPTIMIZER Smart Patient ID Card – Maltese
Part Number: 13-270-003-mt
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART

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

Lithuanian

 

OPTIMIZER Smart Patient ID Card – Lithuanian
Part Number: 13-270-003-lt
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART

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

OPTIMIZER Smart System Patient’s Manual – Lithuanian
Part Number: 13-250-003-lt
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Hungarian

 

OPTIMIZER Smart Patient ID Card – Hungarian
Part Number: 13-270-003-hu
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART

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

OPTIMIZER Smart System Patient’s Manual – Hungarian
Part Number: 13-250-003-hu
Revision Number: 07
Effective Date: 05-April-2021
Model: SMART

Croatian

 

OPTIMIZER Smart Patient ID Card – Croatian
Part Number: 13-270-003-hr
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART
MRI Safety Information Card for OPTIMIZER Smart IPG – Croatian
Part Number: 13-290-013-hr
Revision Number: 00
Effective Date: 03-February-2021
Model: SMART

Slovakian

 

OPTIMIZER Smart Patient ID Card – Slovakian
Part Number: 13-270-003-sk
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART

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

Estonian

 

OPTIMIZER Smart Patient ID Card – Estonian
Part Number: 13-270-003-et
Revision Number: 02
Effective Date: 31-March-2021
Model: SMART

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

Spanish

 

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

Previous Revisions

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

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

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

Previous Revision

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

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

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

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
Model: SMART

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
Model: SMART

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
Model: SMART

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

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