What items are compatible with the sterilizer?

Please check the list in the Resources section of this site.

 
If your item is not listed or you are unsure, contact your local SterLink representative for assistance.

SterLink sterilizers are designed to be easy to use.

Refer to our user manual and instructional videos.

We also have live, U.S. based customer service via online and phone. You local SterLink representative is also a resource to help plan for a successful implementation and continued operation.

Yes.

There are two devices: 

  • STERLINK Plus: 05/25/2023 
  • STERLINK mini: 04/14/2023 

The link to the FDA website is: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

  • Once in the site, go to Applicant Name and type in: Plasmapp
  • Here you will find quite a bit of information about the 510k
  • The Animal Health Market version of the Low-Temperature Plasma Sterilizers have been selling in the US since 2021.  Over this time, the devices have been pressure tested and improved within the Animal Health space and the technology and learnings were engineered into the Human Health Market devices. 
  • The devices are currently sold in over 50 countries, this is their entry into the US market.
  • Please refer to the Medical Device Compatibility List on our website. If you are not able to find the information that you are looking for, please let us know the product information, manufacturer, product name, and model number, then our validation team can verify if they are compatible.

Yes. If you are unsure if your device is approved, contact customer service prior to sterilizing the device.

Only items certified by and purchased from the manufacturer’s authorized distributors may be used in the sterilizers.

No. The final output from the sterilizers is filtered oxygen and water vapor.

  • The STERLINK sterilizer can be operated in 2 modes: Pouch Mode and Chamber Mode.
  • Pouch Mode uses a consumable called the STERPACK plus and runs a 14-minute sterilization cycle. 
  • In Pouch Mode, the needle penetrates a silicone nipple at the top of the STERPACK plus.  The hydrogen peroxide in the cartridge is released into the pouch due to the differential pressure and causes a vacuuming effect of the pouch.  Once the medical device is sterilized it will remain sterile in the sealed pouch for up to 6 months.
  • Chamber Mode uses a consumable called the STERLOAD and runs a 36-minute sterilization cycle. In this mode, the entire chamber is used, and no pouch is needed.
  • The STERLINK’s chamber operates at 130F and is regulated by several redundant temperature sensors within the walls of the chamber and does not harm instruments like the vacuum steam sterilizers.  The 130F operating temperature is not for killing bacteria but rather to dry any moisture in the chamber.  If excessive moisture is detected by the Plasmapp detection system, the unit will stop with a precautionary message to dry out the tools prior to sterilization.  Consider the low heat like a blow dryer.  

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