Справочник Пользователя для CVRx BAROSTIMIPG1
BAROSTIM NEO LEGACY REFERENCE GUIDE
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Recommendations
Lead explantation should be considered with caution if, in the opinion of the treating physician, it is medically
appropriate.
appropriate.
The surgical approach and techniques for the explantation of Neo Legacy will vary with the preference of the
explanting surgeon. Although the approach and the techniques may vary, essential requirements for proper and
safe explantation are included in this section. Should the IPG require explantation, the electrode(s) (one or both
sides if applicable) may or may not have to be removed at the same time depending on the clinical situation.
explanting surgeon. Although the approach and the techniques may vary, essential requirements for proper and
safe explantation are included in this section. Should the IPG require explantation, the electrode(s) (one or both
sides if applicable) may or may not have to be removed at the same time depending on the clinical situation.
Antibiotic Coverage – Not Infected
If the device is being removed for reasons other than infection, it is recommended that an antibiotic providing
gram-positive coverage be administered within 30 minutes of the skin incision and continued postoperatively
for 24 hours following the procedure.
gram-positive coverage be administered within 30 minutes of the skin incision and continued postoperatively
for 24 hours following the procedure.
Antibiotic Coverage – Infected
If the device is being removed due to an infection and cultures have identified the responsible bacteria,
antibiotics that would be effective against identified bacteria should be initiated preoperatively and continued
postoperatively until signs of infection have resolved (normal temperature, white blood cell count, and
differential white blood cell count). Otherwise it is recommended that broad spectrum antibiotics be initiated
preoperatively and antibiotics be narrowed when culture and sensitivity results are available from
intraoperative cultures.
antibiotics that would be effective against identified bacteria should be initiated preoperatively and continued
postoperatively until signs of infection have resolved (normal temperature, white blood cell count, and
differential white blood cell count). Otherwise it is recommended that broad spectrum antibiotics be initiated
preoperatively and antibiotics be narrowed when culture and sensitivity results are available from
intraoperative cultures.
IPG Explantation
CAUTION: Palpate the site of the IPG and lead prior to first incision to verify the lead is not under the
targeted incision site for IPG removal.
targeted incision site for IPG removal.
NOTE: Electrocautery at a low but effective power can be used to minimize the potential of damaging the
leads during dissection. Do not use scalpels on or near the CSL as damage could occur leading to failure of the
lead.
leads during dissection. Do not use scalpels on or near the CSL as damage could occur leading to failure of the
lead.
1. Initiate a telemetry session with the IPG and press the Stop ,button. Save Report (if desired) and End
Session.
2. Open the incision inferior to the clavicle over the implanted IPG.
3. Dissect down to the IPG. Portions of the leads may need to be dissected in order to remove the IPG.
4. Cut the fixation sutures. Prior to removing the IPG, it is recommended to disconnect the leads from the
connector ports (refer to steps 5 and 6). Remove the IPG from the pocket.
5. Using the torque wrench, turn the setscrews counterclockwise to loosen the setscrews for each CSL
connector.
6. Remove the CSLs from the IPG connector ports.
7. Remove the IPG from the sterile field.
8. Return the explanted IPG to CVRx for examination and proper disposal.
NOTE: Prior to returning the IPG, obtain a CVRx Returned Goods Authorization kit and follow the procedure
contained within it.
contained within it.