Pne Lead Removal; Label Symbols - Axonics 1901 PNE Lead Manual Del Usario

2. Connect the lead to the desired connector on the Basic Trial Cable (Figure 8).
Figure 8 . Insert the pin of the PNE lead into the Basic Trial Cable connector labeled "1" or "2".
3. Connect the basic trial cable to the External Trial Stimulation (Figure 9).
Figure 9 . Align the raised grey bar on the Trial Stimulator with the raised bar on the Basic Trial Cable (left).
Note: The basic trial cable can be cleaned with sterile water or isopropyl alcohol as needed.
4. Check the impedances of the connections between the PNE lead(s), the ground pad (if present), and the TS using
the Clinician Programmer. Resolve any impedance issues before proceeding.
5. Dress the PNE implant site with gauze and place gauze under the PNE connectors of the Basic Trial Cable. Coil
excess length of the Basic Trial Cable to provide strain relief and minimize the unsecured cable length. Use
Tegaderm to cover the PNE lead implant site and the connection to the Basic Trial Cable.

PNE LEAD REMOVAL

At the end of trial stimulation period, the PNE lead should be removed.
1. Turn off TS stimulation. Disconnect all cables. Refer to the TS manual for instructions on turning off the TS.
2. Gentle traction can be used to remove the lead.
3. Follow the appropriate protocol for disposal of biohazardous waste. For e.g. to dispose of the PNE lead, the trial
cables, and surgical dressings.

LABEL SYMBOLS

This section explains the symbols found on the product and packaging.
Symbol
Manufacturer
Product Model Number
Manufacturing Date
Conformité Européenne (European
Conformity). This symbol means that the
device fully complies with AIMD Directive
90/385/EEC (Notified Body reviewed) and
RED 2014/53/EU (self-certified)
Refer to instructions for use (Consult
accompanying documents)
Temperature limitation
Description Symbol
Sterilized using Ethylene oxide
Use by
Do not use if package is damaged
Do not resterilize
Authorized representative in the European
community
Open here
15
Description