Intended Use - Boston Scientific Precision Spectra OMG Manual Del Usuario

Precision Spectra™
OMG™ Adapter
Model SC-9315

Intended Use

Note: Throughout this document, the "Boston
Scientific ETS" refers to ETS model numbers
SC-5132; SC-5160; and SC-5170.
The Precision Spectra Observational Mechanical
Gateway (OMG) Adapter is used to connect the
Boston Scientific ETS to an OMG™ Connector-M
(Model # SC-9310) or an OMG Connector-A (Model
#SC-9305). It is intended to provide physicians
with the capability to gain acute feedback from the
patients to assess for any pain relief difference
between the Medtronic and the St. Jude (Abbott)
Systems and the Boston Scientific SCS Systems.
The Precision Spectra OMG Adapter is for
evaluation purposes only. It is an adjunct to, but
not part of, the Boston Scientific SCS Systems.
Full Trial of a Boston Scientific SCS System should
precede permanent implant.
Refer to the Indications for Use DFU for indications
for use and the appropriate Information for
Prescriber DFU for contraindications.
This manual describes the use of the Precision
Spectra OMG Adapter (SC-9315) in conjunction
with the OMG Connector-A (SC-9305) or OMG-
Connector-M (SC-9310) to connect the Boston
Scientific ETS to the Medtronic or St. Jude (Abbott)
Leads. For connection of the Precision ETS to the
Medtronic or St. Jude (Abbott) Leads, refer to the
OMG Connector-A Directions for Use
OMG Connector-M Directions for Use
CAUTION
Precision Spectra OMG Adapter is for use only
under the direct supervision of a healthcare
professional. The Precision Spectra OMG
Adapter may not be sent home with the patient.
Note: Throughout this document, the term
"OMG Connector" refers to either the OMG
Connector-M or the OMG Connector-A.
Compatibility with Medtronic Leads
When used with the Boston Scientific ETS,
the Precision Spectra OMG Adapter and OMG
Connector-M shall be compatible with the following
Medtronic Leads and OR Cable Assemblies
available prior to September 2013.
Table 1: Compatible Medtronic OR Cables
Medtronic OR Cable Assembly
Twist-Lock Screening Cable
Snap-Lid Connector Cable
Multi-Lead Trialing Cable
and the
.
Intended Use
Model Number
3550-03
355031
355531
Precision Spectra™ OMG™ Adapter
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