Boston Scientific SC-2016 Series, Инструкция по применению

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Percutaneous Leads Directions for Use
Percutaneous Leads Directions for Use
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4. OPTIONAL. Under fluoroscopic guidance, insert the Lead blank through the insertion needle and into the epidural space. Advance the Lead blank
to verify entry into the epidural space, then withdraw the blank.
5. While holding the Lead stylet handle, place the steering cap over the proximal end of the stylet handle with moderate force until it is held in place.
Then slowly insert the Lead, with stylet, through the insertion needle. The Lead stylet should extend to the tip of the Lead.
6. OPTIONAL. If exchange of the Lead stylet is desired, carefully pull out the existing stylet and insert the preferred stylet. While inserting the stylet
into the Lead, if resistance is encountered, withdraw the stylet approximately 3 cm, rotate the Lead and/or stylet, and gently advance the stylet. If
resistance is still encountered, repeat the above procedure until the stylet can be fully inserted.
WARNING: Do not exchange the Lead stylet while the electrode array of the Lead is in the bevel of the insertion needle. If the electrode array
is in the bevel area, remove the Lead from the insertion needle before exchanging the stylet. Inserting the Lead stylet in the Lead while the
electrode array is in the bevel of the insertion needle increases the risk of Lead and tissue damage.
WARNING: If the Lead stylet is removed and reinserted, do not use excessive force when inserting the stylet into the Lead. The use of
instruments, such as forceps, to grasp the stylet during insertion is not recommended as this could result in applying excessive force and could
increase the risk of Lead and tissue damage.
7. Advance the Lead to the appropriate vertebral level under fluoroscopic guidance. A sufficient length of Lead (for example, at least 10 cm, or
approximately three vertebrae) should reside in the epidural space to aid in Lead stabilization.
8. If using a Splitter, proceed to “Lead Connection to Splitter” in this manual. If not using a Splitter, proceed to the instructions for connecting Leads
or extensions to the OR Cable assembly in the appropriate DFU for your SCS System, as listed in your Reference Guide .
Infinion CX Lead Placement for SCS Using the Entrada Needle
1. Position, prep and drape the patient in the usual accepted manner. Inject a local anesthetic at the needle insertion site.
2. Verify that the Entrada needle is fully assembled by holding onto the sheath hub and applying forward pressure on the stylet cap cover.
CAUTION: Do not bend the Entrada needle. Bending the Entrada needle may cause the stylet or LOR adapter to become jammed in the needle
assembly and difficult to remove.
3. Recommended for permanent or permanent-trial procedures: Cut down prior to inserting the Entrada Needle and insert needle into incision.
Creating the incision before inserting the Entrada Needle provides a clear path for sliding the Anchor into the incision.
If cutting down after inserting the Entrada Needle, ensure that the sheath is in place and do not damage the sheath.
4. Under fluoroscopic guidance, place the Entrada Needle into the epidural space with the 14G marking facing up using an angle of 45° or less.
CAUTION: Use only an Entrada Needle provided by Boston Scientific. Other needles may damage the Lead. Turning the bevel ventral (down)
may result in Lead damage. An angle of more than 45° increases the risk of Lead damage.
WARNING: The angle of the insertion needle should be 45° or less. Steep angles increase the insertion force of the stylet and also present more
of an opportunity for the stylet to pierce the Lead and cause tissue damage.
Note: If the needle must be repositioned during this procedure, or if the sheath becomes damaged, reassemble the needle outside of the
body with a new sheath, see “Assembling and Reassembling the Entrada Needle” section of this manual.