Pedestal LGA surface cleaning instructions

This work instruction is applicable to the exterior surface cleaning of NeuroPort™ and CerePort™ implant assembly pedestals as long as the pedestal design incorporates the Rodger’s 4003 epoxy ceramic LGA and 6-4 titanium alloy metal.

The use of distilled water, isopropyl alcohol and 3% hydrogen peroxide in water have been shown to cause no detrimental effect on the titanium and/or LGA of the implant assembly pedestal. However, this Work Instruction and associated validation can in no way guarantee that the cleaning agents and techniques describe herein will remove all possible organic and inorganic contaminants.


EQUIPMENT AND MATERIALS
1. Distilled water (ideally sterile distilled water to minimize the risk of infection).
2. VWR Product Number 10812 - spearhead shaped, low organic and low inorganic foam tip applicator swabs with a thermally-reticulated fine-pore foam structure and glass-filled nylon handle.
3. Commercially available 3% hydrogen peroxide in water.
4. Chemtronics polyurethane ChemSwab™ saturated with isopropyl alcohol and individually sealed in a metal foil package. Chemtronics Product Number CS25.


PROCEDURE


1. First, attempt to accomplish the desired cleaning effect using distilled water. Using a foam tipped applicator that has been dipped in distilled water scrub the LGA surface thoroughly for approximately five seconds. Then, using the same applicator clean the pedestal rim, threads and three alignment pin slots. Repeat this process two more times with a new applicator each time. Wipe both the LGA and titanium surfaces using a fresh, dry foam tipped applicator and then allow the pedestal to air dry for at least five minutes.

2. Assess the effectiveness of the cleaning. If there appears to be residue left behind after the distilled water cleaning proceed on to Step 3.

3. Clean the pedestal LGA surface using a fresh ChemSwab™ foam tip applicator saturated with isopropyl alcohol (IPA). Scrub the LGA surface thoroughly for about five seconds. Then, using the same applicator clean the pedestal rim, threads and three alignment pin slots. Repeat this process two more times with a new IPA saturated Chemtronics applicator each time. Wipe both the LGA and
titanium surfaces using a fresh, dry foam tipped applicator and then allow the pedestal to air dry for a minimum of five minutes.

4. Assess the effectiveness of the cleaning. If there still appears to be residue left behind after the IPA cleaning proceed on to step 5.

5. Clean the pedestal LGA surface using a foam tipped applicator that has been dipped in 3% hydrogen peroxide. Scrub the LGA surface thoroughly for about five seconds. Then, using the same applicator clean the pedestal rim, threads and three alignment pin slots. Repeat this process two more times with a new hydrogen peroxide saturated applicator each time. Wipe both the LGA and titanium surfaces using a fresh, dry foam tipped applicator and then allow the pedestal to air dry for a minimum of five
minutes.