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