Identifying The Ipg; Directions For Use; Creating An Ipg Pocket - St. Jude Medical GII Proclaim Manual De Instrucciones

Identifying the IPG

Before implanting the IPG, you can view the model number engraved on the IPG. After implantation,
you can identify the IPG using a radiopaque identification tag that you can view with standard X-ray
procedures. The tag, which is located in the lower left corner of the IPG when the logo side of the IPG
is facing toward you, contains a code in the following format: SJMLN. SJM designates
St. Jude Medical as the manufacturer; LN is a letter and a number combination that identifies the
model family (see the following figure).
For the Proclaim™ IPG, the code is SJM A1. To determine the exact model IPG that is implanted,
use the clinician programmer app to communicate with the IPG and view IPG information. See the
clinician's manual for the clinician programmer for instructions.
Figure 1. Location of the IPG code on a small IPG (left) and large IPG (right)

Directions for Use

Read this section carefully for suggested directions for use related to the IPG. For directions for use
for other system components not covered in this document, see the clinician's manual for the
appropriate device.
NOTE: Before the surgical procedure, set up communication between the clinician
programmer and the IPG while the IPG is in its sterile packaging to ensure that it is
functional. If the IPG has never established communication with a programmer, you must
first activate the IPG for communication ("wake up" the IPG) by holding a magnet over the
IPG for 8 seconds.

Creating an IPG Pocket

The following steps outline the suggested procedure to create an IPG pocket:
Determine the site for the IPG, ensuring that the lead is long enough to reach the pocket and
1.
provide a strain relief loop.
NOTE: The IPG should be located in an area that the patient can easily reach with the
programming wand. Common sites for implantation are: along the midaxillary line, in the
upper buttock along the posterior axillary line (taking care to avoid the belt line), and in the
area over the abdomen just below the lowermost rib. To ensure a flat area is selected, you
can mark a flat area prior to the surgical procedure while the patient is in a sitting position.
CAUTION: Do not place the IPG deeper than 4.0 cm (1.57 in) because the clinician
programmer may not communicate effectively with the IPG.
Create the pocket so that the IPG is parallel to the skin surface and no deeper than 4.0 cm
2.
(1.57 in) below the skin surface.
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