Intended Use - Boston Scientific Precision Spectra OMG SC-9315 Manual Del Usuario

Precision Spectra™
OMG™ Adapter
Model SC-9315

Intended Use

Note: Throughout this document, the
"Boston Scientific ETS" is used to signify
either the Precision Spectra™ External Trial
Stimulator or Spectra WaveWriter™ External
Trial Stimulator.
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 the physician
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 Precision
Spectra System or Spectra WaveWriter System.
The Precision Spectra OMG Adapter is for
evaluation purposes only. It is an adjunct to, but not
part of, the Precision Spectra System or Spectra
WaveWriter System. Full trial of the Precision
Spectra System or Spectra WaveWriter System
should precede permanent implant.
Refer to the Indications for Use manual for
indications. Refer to the Information for Prescribers
manual 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,
please refer to the instruction manuals for the OMG
Connector-A (SC-9305) and OMG Connector-M
(SC-9310).
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" is used to signify 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.
Medtronic OR Cable Assembly
Twist-Lock Screening Cable
Snap-Lid Connector Cable
Multi-lead Trialing Cable
Medtronic Lead
Pisces Quad™
Pisces Z-Quad™
1×8 percutaneous lead
8 contact trial lead
Resume™ II & TL
On-Point PNS™
SymMix™
Specify™ 2×4
Specify™ 2x8
Hinged Specify™
Vectris™ SureScan® MRI
1x8 Subcompact
Vectris™ SureScan® MRI
1x8 Compact
Vectris™ SureScan® MRI
Trial Leads
Specify™ 5-6-5
Precision Spectra™ OMG™ Adapter
Intended Use
Model Number
3550-03
355031
355531
Model Number
3487A**, 3887**, 3888**
3890**, 3891**, 3892**
3776, 3777, 3778
3873, 3874, 3875
3587A**, 3986A**
3987A**
3982A**
3998
39286
3999**
977A160, 977A175,
977A190
977A260, 977A275,
977A290
977D160, 977D260
39565*
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