Intended Use - Boston Scientific Precision Spectra OMG Manual Del Usuario

Precision Spectra™ OMG
Model SC-9315

Intended Use

The Precision Spectra Observational Mechanical
Gateway (OMG) is used to connect the Precision
Spectra 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 (formerly Advanced
Neuromodulation Systems (ANS)) Systems and the
Boston Scientific Precision Spectra System.
The Precision Spectra OMG is for evaluation
purposes only. It is an adjunct to, but not part of, the
Precision Spectra System. Full trial of the Precision
Spectra System should precede permanent implant.
Refer to the Precision Spectra Indications
for Use for indications. Refer to the Precision
Spectra Information for Prescribers manual for
contraindications.
CAUTION
Precision Spectra OMG is for use only under the
direct supervision of a healthcare professional.
The Precision Spectra OMG 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.
OMG Connector-M Compatibility
The Precision Spectra OMG and OMG Connector-M
shall be compatible with the following Medtronic
leads and OR Cable Assembly 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
Pisces Quad, Pisces Z-Quad, Resume II, Resume TL, On-Point
PNS, SymMix, Specify, Hinged Specify, and Vectris are trademarks
of Medtronic, Inc.
* These models numbers should be programmed in
manual mode
** Program only the mapped contacts on the
representative Boston Scientific lead
OMG Connector-A Compatibility
The Precision Spectra OMG and OMG Connector-A
shall be compatible with the following St. Jude
leads and OR Cable Assembly available prior to
September 2013.
Precision Spectra™ OMG
90870349-03 REV C
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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