Important Safety Information:
The ExEm® Foam Kit is intended for use by medical professionals skilled in ultrasound tubal patency testing. The ExEm® Foam Kit is intended for single use only.
Contraindications
• Do not use the foam during pregnancy.
• Do not use the foam if the patient may be pregnant.
• Do not use the foam between ovulation and menstruation.
• Do not use the foam in the presence of active pelvic infection, sexually transmitted diseases and profuse bleeding.
• Do not use the foam in case of allergy to any of the constituents of ExEm® Gel (hydroxyethylcellulose, glycerol and
purified water).
Precautions and warnings
• The ExEm® Foam Kit should be considered as contaminated medical waste after use.
• Do not use if package has been previously opened or damaged.
• This device is intended for single use only. Any foam not used in one examination session must be discarded.
• Do not reuse, re-sterilize or autoclave. Reuse of single use devices creates a potential risk of patient or user infections.
Contamination of the device may lead to injury, illness or death of the patient. Cleaning, disinfection and sterilization
may compromise essential material and design characteristics leading to device failure. The manufacturer will not be
responsible for any direct, incidental or consequential damages resulting from re-sterilization or reuse.
• Do not use the ExEm® Foam Kit after the expiry date of the ExEm® Gel, the ExEm® Water, the coupling device and/or
the GIS catheter.
• Do not use the ExEm® Gel and the ExEm® Water separately for Hysterosalpingo Sonography.
• The ExEm® Gel and the ExEm® Water are not to be used for injections.
Note Some patients may experience painful uterine contractions, vasovagal reaction, abdominal pain, fluid loss or
spotting. These symptoms are well known and related to all intra-uterine and tubal patency testing procedures. Pain
treatment should be according to local protocol.
