Boston Scientific OMG SC-9305 Manual Del Usuario página 3

OMG™ Connector – A
Model SC-9305
Intended Use
The Observational Mechanical
Gateway (OMG) Connector - A is used
to connect the Precision
Advanced Neuromodulation Systems OR
(Model # 3009) Cable Assembly. 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 Advanced Neuromodulation Systems and
the Boston Scientific System.
The OMG Connector - A 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.
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
The OMG Connector - A shall be compatible
with the following Advanced Neuromodulation
Systems leads that connect to the OR Cable
Assembly available prior to February 2007:
ETS to the
®
Model Name
Trial lead, 4-Channel
Trial lead, 8-Channel
Axxess Trial Lead
®
Octrode
®
Quattrode
®
Axxess
®
Lamitrode 22
®
Lamitrode 4
®
Lamitrode 8
®
Lamitrode 44 and 44C
®
Lamitrode Tripole 8
®
Lamitrode 88 & 88c
®
Axxess, Octrode Quattrode and Lamitrode are
trademarks of Advanced Neuromodulation Systems
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 or your healthcare
professional.
2. Turn off the non-Precision External Trial
Stimulator (ETS).
OMG™ Connector – A
9055568-008 Rev A Page 3 of 34
Intended Use
Model Number
3046
3086
4044, 4054
3183, 3186, 3189,
3181
3143, 3146, 3149,
3141, 3153, 3156,
3159, 3151
4143, 4146, 4153,
4156
3222
3240, 3254, 3255
3280
3244, 3262, 3263,
3245, 3264, 3265
3208
3288, 3289