Boston Scientific Precision Spectra OMG SC-9315 User manual

Precision Spectra™
OMG
Model SC-9315
CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.
90870349-03 REV C
en de fr nl es pt it pt-br no sv da tr ru ar el cz sk

Precision Spectra™ OMG
<Running Header>
Precision Spectra™ OMG
90870349-03 REV C ii of ii
This page intentionally left blank.
en

Precision Spectra™ OMG
Intended Use
Precision Spectra™ OMG
90870349-03 REV C 1 of 72
en
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 Scientic 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 Model Number
Twist-Lock Screening Cable 3550-03
Snap-Lid Connector Cable 355031
Multi-lead Trialing Cable 355531
Medtronic Lead 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
Specify™ 2x8 39286
Hinged Specify™ 3999**
Vectris™ SureScan® MRI
1x8 Subcompact
977A160, 977A175,
977A190
Vectris™ SureScan® MRI
1x8 Compact
977A260, 977A275,
977A290
Vectris™ SureScan® MRI
Trial Leads 977D160, 977D260
Specify™ 5-6-5 39565*
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 Scientic 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
Directions for Use
Precision Spectra™ OMG
90870349-03 REV C 2 of 72
en
St. Jude OR Cable Assembly Model Number
OR Cable Assembly 3009
St. Jude Lead Model Number
Trial lead, 4-Channel 3046**
Trial lead, 8-Channel 3086
Axxess® Trial Lead 4044**, 4054**
Octrode® 3183, 3186, 3189,
3181
Quattrode® 3143**, 3146**,
3149**, 3141**,
3153**, 3156**,
3159**, 3151**
Axxess® 4143**, 4146**,
4153**, 4156**
Lamitrode® 22 3222*
Lamitrode® 4 3240**, 3254**,
3255**
Lamitrode® 8 3280
Lamitrode® 44 and 44C 3244*,
3262*, 3263*,
3245*,3264*, 3265*
Lamitrode® Tripole 8 & 8c 3208,* 3210*
Lamitrode® Tripole 16 & 16c 3214, 3219
Lamitrode® 88 & 88c 3288*, 3289*
Penta 3228*
Lamitrode S-8 3283, 3286, 3268,
3269
Axxess, Octrode Quattrode and Lamitrode are trademarks of Advanced
Neuromodulation Systems
* These models numbers should be programmed in
manual mode
** Program only the mapped contacts on the
representative Boston Scientic lead
Directions for Use
Connecting the Precision Spectra OMG
1. Inspect the Precision Spectra OMG, OMG
Connector-M, or OMG Connector-A for
damage. If damaged, do not proceed. Return
the damaged component(s) to Boston Scientic
Neuromodulation or your healthcare professional.
2. Turn off the Non-Precision Spectra External Trial
Stimulator (ETS).
CAUTION
Failure to turn off the non-Precision Spectra
ETS before connecting the OMG Connector
may result in excess stimulation.
3. Disconnect the proximal end(s) of the non-
Precision Spectra OR Cable Assembly and insert
into the corresponding port on the OMG Connector:
A. OMG Connector-A
Disconnect the proximal end(s)
of the non-Precision Spectra OR
Cable Assembly and insert it into
the corresponding port on the OMG
Connector-A. Plug the non-Precision
Spectra OR Cable Assembly into the
OMG Connector-A socket(s) labeled “1-
L” (left) and “2-R” (right). If only a single
lead is being used, connect it to “1-L”.
B. OMG Connector-M
Medtronic Twist-Lock Screening Cables
(Model # 3550-03)
• If the trial is using the Twist-
Lock Screening Cables, plug the
non-Precision Spectra 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™ 3D software.

Precision Spectra™ OMG
Directions for Use
Precision Spectra™ OMG
90870349-03 REV C 3 of 72
en
• For a two-lead trial, connect the
non-Precision Spectra 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
3D software. Medtronic Snap-Lid
Connector Cable (Model # 355031)
or Medtronic Multi-lead Trialing Cable
(Model # 355531)
• If the trial is using the Snap-Lid
Connector Cable, plug the non-
Precision Spectra connector into the
OMG Connector-M socket labeled
“Single Connector.” If 2 four contact-
leads are placed in the Snap-Lid
Connector Cable, the rst and second
leads show up as contacts 1-4
and 5-8, respectively, in the Bionic
Navigator 3D software. The 4-contact
leads should be programmed in
Manual Mode.
• If 2 eight-contact leads are used, the
leads show up as contacts 1-8 and 9-16
in the Bionic Navigator 3D software.
4. Place the OMG Connector in a secure location
on a at surface so that patient movement will
not cause the connector to fall.
5. Align and connect the “1-L” and “2-R” ports on
the Precision Spectra OMG and the respective
OMG Connector.
6. Making sure that the Precision Spectra ETS is
OFF, connect the Precision Spectra ETS to the
port labeled “CD” on the Precision Spectra OMG.
CAUTION
Failure to turn off the Precision Spectra ETS
before connecting the Precision Spectra OMG
may result in excess stimulation.
Programming the Precision Spectra
ETS
1. Link the Precision Spectra Clinician
Programmer (CP) to the Precision Spectra
ETS per the standard procedure.
2. Use the Bionic Navigator 3D Software to
program the Precision Spectra ETS. Refer to the
list of competitor leads for guidance in selecting
the programming mode to use with the lead.
Disconnecting the Precision Spectra
OMG
1. Turn OFF stimulation.
2. Disconnect the Precision Spectra ETS from the
Precision Spectra OMG.
3. Disconnect the Precision Spectra OMG from the
OMG Connector.
4. Disconnect the proximal end(s) of the non-
Precision Spectra OR Cable Assembly(ies) from
the OMG Connector.
CAUTION
Failure to turn off the Precision Spectra ETS
before disconnecting the Precision Spectra
OMG may result in excess stimulation.
Cleaning the Precision Spectra OMG
The Precision Spectra OMG can be cleaned using a
mild detergent applied with a lightly dampened cloth
or tissue. Residue from soapy detergents should be
removed with a cloth lightly dampened with water.
Do not use abrasive cleansers for cleaning.