Symphion Hysteroscope Directions for Use

This manual provides the information you need to operate and maintain the Symphion® 6.3 Hysteroscope. It is essentialthat you read and understand all the information in this manual before using or maintaining this device.

1. Device description

The Symphion 6.3 Hysteroscope is a reusable instrument for usein visualizing the body cavity during diagnostic and surgical hysteroscopic procedures.

The Symphion 6.3 Hysteroscope is for use with the Symphion® System.

2. Intended use/Indications for use

The Symphion 6.3 Hysteroscope is intended to provide thephysician with a means for endoscopic diagnostic and therapeutic surgical procedures. It is indicated for use in diagnostic examination and surgical hysteroscopic procedures.

3. Contraindications

  • Acute pelvic inflammatory disease
  • Inability to distend the uterus
  • Cervical stenosis
  • Cervical/vaginal/Pelvic infection
  • Uterine bleeding or menses
  • Known pregnancy
  • Invasive carcinoma of the cervix/endometrial cancer
  • Recent uterine perforation
  • Medical contraindication or intolerance to anesthesia

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