Abbott Eterna 32400, Руководство для клиницистов

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Package Contents
In addition to the product documentation, the generator kit contains the following items:
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1 generator (Model 32400)
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1 pocket sizer (Model 12720)
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1 torque wrench (Model 1101) ▪
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2 port plugs (Model 12710)
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Identifying the Generator
You can identify the generator in the following ways:
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The model number and barcode are engraved on the generator.
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The generator has a radiopaque identification tag in the lower right corner that can be viewed with ▪
standard X-ray procedures. On the tag, ABT identifies Abbott Medical as the manufacturer, and the
letter and a number combination A2 identifies the model family. Additionally, the header port plug is
radiopaque and, if used, is visible with standard x
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ray procedures (see the following figure).
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The clinician programmer app when connected to the generator indicates the model number and allows
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you to view other generator information. See the clinician programmer manual for instructions.
Figure 2. Location of the generator code on the Eterna™ implantable pulse generator
Directions for Use
Read this section carefully for suggested directions for use related to the Eterna™ implantable pulse
generator. For directions for use for other system components such as the clinician programmer, see the
clinician’s manual for the clinician programmer.
NOTE: Before the surgical procedure, set up communication between the clinician programmer and the
generator while the generator is in its sterile packaging to ensure that it is functional and fully charged. If
the generator has never established communication with a programmer, you must first activate the
generator for communication by holding the magnet over the generator for 8 to 25 seconds.
NOTE: Ensure the generator is fully charged before implantation. The generator can be charged through its
sterile packaging.
Creating a Generator Pocket
The following steps outline the suggested procedure to create an generator pocket:
1. Determine the site for the generator, ensuring that the lead is long enough to reach the pocket and 1.
provide a strain relief loop.
NOTE: Common sites for generator 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 generator deeper than 2.5 cm (0.98 in.) because the clinician
programmer, generator charger, and patient magnet may not communicate effectively with the
generator.
CAUTION: Ensure the generator is set to Surgery mode using the clinician programmer.
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