Specifications; Pne Lead Implant Procedure - Axonics 1901 PNE Lead Manual Del Usario

– Syringe Needle, 25 Gauge x 1.5
– Medicine Cup 2oz./60cc
• The contents of the kit (except for PNE Ground Pad and Cable, Needle Stimulation Pad and Cable, and Basic Trial
Cable) are STERILE. All components are intended for single use only.
Caution:
Sterile components should be discarded if their sterility is compromised. Check to ensure packaging is intact
prior to opening. Do not clean and reuse or re-sterilize any sterile items that make contact outside a sterile field.
Caution:
Each component of the Axonics SNM System is designed for use only with the other components and
accessories of the Axonics SNM System. The components and accessories of the Axonics SNM System should
not be used with any other neuromodulation systems.

SPECIFICATIONS

Table 1 shows the PNE lead specifications. For detailed descriptions and specifications for other components and
accessories, refer to the product literature packaged with those devices.
Physical Properties
Lead length
Number of electrodes
Electrode length
Materials
• Conductor wire
• Proximal connector
• Stimulating electrodes
• Conductor wires Insulation
Note: All dimensions are approximate.

PNE LEAD IMPLANT PROCEDURE

The following section describes the procedure for implanting the Axonics PNE lead.
Procedure supplies
In addition to the surgical tools required by the physician, the following supplies are needed for the implantation of
the PNE lead:
• Axonics PNE Implant Kit (Model 1701).
• PNE lead (optional for bilateral lead implantation) (Model 1901).
Procedure preparation
1. Place the patient prone. Create an approximate 30° flexion at the hip and knees. Place a pillow underneath the
patient abdomen/hips if necessary. This will help flatten the sacrum in the horizontal plane.
2. Prep the patient's lower back out laterally to the hips. Extend the prep down to the buttocks, perianal area and
perineum for sterile surgery.
3. Administer local anesthesia in the area of the targeted sacral foramen. Inject anesthesia down to the sacrum.
4. Affix the stimulation ground pad (non-sterile) to the skin.
a. Clean and dry skin area where ground pad is to be affixed (trimming hair from area is often helpful).
b. Open the pouch of the ground pad.
c. Peel the plastic packing off the ground pad.
d. Apply ground pad to the skin area. Hold in place for 15 seconds.
e. Insert the black plug into the CP ground ( ) next to Needle Test Stimulation Cable (Figure 2).
5. Remove the needle test stimulation cable from the packaging.
6. Ensure that the stimulation amplitude on the CP is set to zero.
7. Insert the black plug of the needle test stimulation cable into the CP outside the sterile field (Figure 2). Keep
the clip end of the cable in the sterile field.
Note: Ensure all cable connections are secure
Table 1 . PNE Lead specifications
41 cm
1
10 mm
Stainless steel
Stainless steel
Stainless steel
Fluoropolymer
11