Hologic Definity User manual

Definity™Cervical Dilator
SYSTEM OVERVIEW
QUICK REFERENCE GUIDE
PLUNGERDILATION ZONE
CHARGE ZONE
(GREEN)
STOPCOCK
RELEASE
BUTTON
LUER
CONNECTOR
LOCKING NUT
10CC MARK
PRESSURE
INDICATOR
PROXIMAL HANDLE
ACORN TIP
DISTAL HANDLE
DILATION QUICK SETUP | Preparing the Dilator
FILL the ination device with 10cc of sterile saline
CONNECT the inflation device to the dilator catheter
CHARGE the outer balloon by rotating the plunger
clockwise until the pressure indicator is
within the charge zone (green)
RETRACT the outer balloon and now
you’re ready for dilation
PREPARE the outer balloon by pushing
the proximal handle forward
1-2 cm

MISC-06164-001 Rev. 001 ©2019 Hologic, Inc. Hologic, Definity, SureAccess, The Science of Sure, and associated logos
are trademarks or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.
IMPORTANT SAFETY INFORMATION
The Definity™ cervical dilator catheter system is intended to be used whenever cervical softening and dilation is desired.
Some examples are: treatment of cervical stenosis, IUD placement and removal, placement of instruments for intrauterine
radiotherapy, endometrial biopsy, global endometrial ablation, uterine tissue removal, uterine curettage, diagnostic
hysteroscopy, operative hysteroscopy. This device is not intended for use in the induction of labor. Use of the Definity
cervical dilator catheter system is contraindicated in patients with: an active genital tract infection such as genital
herpes, pelvic structure abnormality that prevents passage of the device, or invasive cervical cancer. This device is also
contraindicated for the induction of labor.
QUICK REFERENCE GUIDE
This Quick Reference Guide is designed to be used in conjunction with, not to replace, the Definity cervical dilator Instructions for
Use. Prior to performing the dilation, the physician must review and be familiar with the full operating instructions for the Definity
cervical dilator, as well as any warnings, contraindications, and safety information.
Definity Cervical Dilator
SYSTEM OVERVIEW
DILATION QUICK SETUP | Performing the Dilation
INSERT the Definity cervical dilator
ensuring the Acorn tip is snug
against the cervix
DEPLOY the inner balloon by rotating the plunger
until the pressure indicator drops below the
charge zone (green)
ROTATE the stopcock 90 degrees
COMPLETE the dilation and remove
DILATE by slowly turning the plunger
until the pressure indication is
in the dilation zone (blue)