When will I receive my upgrade?

Your Surgical sales rep will be in contact with you to provide estimated timing for your upgrade.  We will be working through the upgrade process as expeditiously as possible.  Please feel free to call your Surgical sales rep about this at any time.

How do I get trained on the new device? What resources are available to train the OR staff?

A training kit will be delivered to your designated Training Facilitator or other responsible management, in advance of your upgrade.  The kit will include a training DVD, presentations and quick reference cards.  When your Stryker representative is on-site to conduct the upgrade, he/she will also in-service you on the new features, functions, labeling, warnings and cautions.

Who needs to be trained?

A Stryker representative will be onsite to facilitate an in-service on the upgrade.  We will also provide you with a training kit to implement according to your facility’s training protocol.  Each facility will need to identify users needing to attend the in-service and receive training.  Your Stryker representative or Neptune Specialist will be available to assist.

What does the in-service consist of? 

The in-service consists of an explanation of the upgrades to the device, including new features, functions, warning and cautions.

Do I need to continue practicing the recall requirements? 

Yes, you are required to continue practicing all recall requirements (i.e., staff training and OR checklist) until your Neptune 2 units have been upgraded to the latest 510(k) cleared version and you have signed the “Upgrade Completion” form.

Can I take my placard off?

The placards must remain in place until after the upgrade is complete. At that time, the Stryker technician will remove previous placards and place the new labels, cautions and warnings on the device.

How can I get a copy of the 510(k) clearance letter?

Your Surgical sales rep can supply a copy of the letter issued to your facility.

What model does this affect? 

This upgrade notification is for the Neptune 2 only.

What about Neptune Gold and Bronze?

Neptune Gold and Bronze systems are cleared devices.  They are affected by the revised medical device recall, dated February 22, 2013, and require  the labeling and placard to use as part of the previous recall.

What about Neptune Silver?

After careful consideration, Stryker has decided not to submit a 510(k) for the Neptune 1 Silver device. You should be working to transition to an alternative form of by March 1, 2013.

How long should I keep my recall materials once my units have been upgraded? 

You should retain recall materials according to your facility’s document retention protocol.

When do I sign the “Upgrade Completion Form”? 

You may sign the “Upgrade Completion” form after you have:

1. Received the training tool kit to implement training according to your facility’s protocol
2. A Stryker Representative has provided on-site in-servicing on the upgraded Neptune 2 units, including a review of the new features, functions, labeling, warnings and cautions and
3. All Neptune 2 units at your facility have been upgraded with the new top cap, software, and on-device labeling.