Boston Scientific OMG Connector - M SC-9310 Instrucciones De Uso página 3

OMG™ Connector – M
Model SC-9310
Intended Use
The Observational Mechanical Gateway (OMG)
Connector - M is used to connect the Precision
ETS to a single Medtronic
Cable (Model # 355031) or up to two Medtronic
Twist-Lock Screening Cables (Model #3550-03).
The OMG Connector - M 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 Medtronic 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 - M shall be compatible with the
following Medtronic leads that connect to the OR
Cable Assembly available prior to February 2007:
Model Name Model Number
Pisces Quad™ 3487A, 3887, 3888
Pisces Z-Quad™ 3890, 3891, 3892
1×8 percutaneous
lead 3776, 3777, 3778
8 contact trial lead 3873, 3874, 3875
Resume™ II & TL 3587A, 3986A
On-Point PNS™ 3987A
SymMix™ 3982A
Specify™ 2×4 3998
Hinged Specify™ 3999
Pisces Quad, Pisces Z-Quad, Resume II, Resume TL,
On-Point PNS, SymMix, Specify and Hinged Specify are
trademarks of Medtronic, Inc.
®
Snap-Lid Connector
®
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 Medtronic ETS
before disconnecting the Medtronic OR
Cable assembly may result in excess
stimulation.
3. Disconnect the proximal end(s) of the non-
Precision OR Cable Assembly and insert into
the corresponding port on the OMG Connector.
• "Twist-Lock Screening Cables" (Medtronic
Model # 3550-03)
* If the trial is using the Twist-Lock Screening
Cables (MDT Model # 3550-03), plug the
non-Precision OR Cable Assembly into
the OMG Connector socket(s) labeled
"1-L" (left) for a single-lead trial. The lead
shows up as contacts 1-4 in the Bionic
Navigator™ software.
* For a two-lead trial, connect the non-
Precision OR Cable Assemblies into "1-L"
(left) and "2-R" (right). The lead shows
up as contacts 1-4 and 9-12 in the Bionic
Navigator software.
• "Medtronic Snap-Lid Connector Cable"
(Model # 355031)
* If the trial is using the Snap-Lid Connector
Cable, plug the non-Precision connector
into the OMG Connector socket labeled
"Single Connector." If 2 four contact-leads
are placed in the Snap-Lid Connector
Cable, the first and second leads show up
as contacts 1-4 and 5-8, respectively, in the
Bionic Navigator software. The 4-contact
leads should be programmed in Manual
Mode.
9055562-011 Rev A
Intended Use
OMG Connector M
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