The Blom-Singer Voice Prosthesis Sizer is a measurement device used by physicians and qualified speech pathologists to select the appropriate Blom-Singer voice prosthesis length. The device measures the length of tracheoesophageal puncture between the trachea and the esophagus. Markers on the device correspond to the length of the prosthesis. The tracheoesophageal puncture tract should always be measured before inserting a voice prosthesis to confirm tract length. The sizer is available in either 16 Fr. or 20 Fr. diameter. Three inserters included.

INSTRUCTIONS FOR USE

DEVICE CLEANING: Puncture Dilator The Puncture Dilator may be cleaned and reused by a single patient as follows: Clean the Puncture Dilator thoroughly with a mild detergent and rinse under a strong flush of tap water. Dry the dilator with sterile gauze. Once a dilator has been cleaned and dried completely, it should be stored in a clean, reclosable plastic bag until its next use. Always handle with clean hands and avoid touching portions of the dilator that will enter the puncture. Precaution: Never clean the device while the dilator is in position in the neck. Always clean the dilator after it has been removed.

INSTITUTION STERILIZATION AND REUSE INSTRUCTIONS The devices of the Blom-Singer Dilation/Sizing System may be cleaned and steam sterilized for reuse by multiple patients as follows: Clean thoroughly with a mild detergent and rinse with water. Sterilize unwrapped in a standard autoclave at 132— 135°C for 3 minutes. Do not sterilize the device in the original packaging. The device may be reused to a limit of 100 times. Inspect the device routinely for structural damage. If there are tears, cracks, or structural damage, do not continue to use. Do not sterilize the sizer inserter.