INSTITUTION STERILIZATION AND REUSE INSTRUCTIONS
The following devices of the Blom-Singer® Dilation/Sizing System may be cleaned and sterilized for reuse between patients to a limit of 60 uses: Puncture Dilator, Dilator-Sizer, Voice Prosthesis Sizer (NOT the sizer inserter stick).
Prior to sterilization, manually hand clean the device:
1. Rinse the article under running water. While rinsing, use a soft bristled brush to brush the device. Use an appropriately sized lumen or channel brush to brush the lumen of the device, as applicable.
2. Immerse the device in a prepared enzymatic detergent solution for 1 minute (following manufacturer's instruction for dilution). While immersed, use a soft bristled brush to brush the device. Use an appropriately sized lumen or channel brush to brush the lumen of the device, as applicable.
3. Remove the device from the bath of detergent solution and rinse under running utility water for 1 minute.
4. Dry the articles using pressurized.
To sterilize after manual cleaning:
Device to be sterilized must be placed in a single sterilization pouch.
Two separate parameters using pre-vacuum steam sterilization autoclave have been validated to a limit of 60 uses:
1. Sterilization at 132°( for 4 minutes after performing 4 preconditioning pulses OR
2. Sterilization at 134°( for 3 minutes after performing 4 preconditioning pulses.
After sterilization cycle is complete:
1. Device requires a minimum drying time of 20 minutes.
2. Inspect the device routinely for structural damage. If there are tears, cracks, or structural damage, discontinue use and replace device.