Intended Use; Directions For Use - Boston Scientific SC-9305 Mode D'emploi

OMG™ Connector – A
Model SC-9305

Intended Use

The Observational Mechanical Gateway
(OMG) Connector - A is used to connect the
Precision ETS to the St. Jude (formerly
™
Advanced Neuromodulation Systems (ANS)) OR
(Model # 3009) Cable Assembly. It is intended to
provide the physician with the capability to gain
acute feedback from the patients to assess for any
pain relief difference between the St. Jude and the
Boston Scientific System.
The OMG Connector - A is for evaluation purposes
only. It is an adjunct to, but not part of, the
Precision System. Full trial of the Precision System
should precede permanent implant.
For connection of the Precision Spectra™ ETS to
the St. Jude leads, please refer to the instruction
manual for the Precision Spectra™ OMG™
Adapter (SC-9315).
CAUTION
The OMG Connector is for use only under
the direct supervision of a healthcare
professional. The OMG Connector may not
be sent home with the patient.
Compatibility
When used with the Precision ETS, the OMG
Connector - A shall be compatible with the
following St. Jude leads that connect to the OR
Cable Assembly available prior to February 2007:
Model Name
Trial lead, 4-Channel
Trial lead, 8-Channel
Axxess Trial Lead
®
Octrode
®
Quattrode
®
Axxess
®
Lamitrode 22
®
Lamitrode 4
®
Lamitrode 8
®
Lamitrode 44 and 44C
®
Lamitrode Tripole 8
®
Lamitrode 88 & 88c
®
Axxess, Octrode Quattrode and Lamitrode are
trademarks of St. Jude

Directions for Use

Connecting the OMG Connector
1. Inspect the OMG Connector for damage.
If damaged, do not proceed. Return the
OMG Connector to Boston Scientific
Neuromodulation.
2. Turn off the non-Precision External Trial
Stimulator (ETS).
CAUTION
Failure to turn off the St. Jude ETS before
disconnecting the St. Jude OR Cable
Assembly may result in excess stimulation.
Intended Use
Model Number
3046
3086
4044, 4054
3183, 3186, 3189,
3181
3143, 3146, 3149,
3141, 3153, 3156,
3159, 3151
4143, 4146, 4153,
4156
3222
3240, 3254, 3255
3280
3244, 3262, 3263,
3245, 3264, 3265
3208
3288, 3289
OMG™ Connector - A
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