Safety and Clinical Data


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, resterilize 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.

Reuse of this product can result in danger to the patient.
Do not use the ExEm® Foam-kit after expiry date of ExEm® gel, the ExEm® water, and/or the coupling device.

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. 


STERILE unless package has been opened or damaged.

FOR SINGLE USE ONLY. DO NOT REUSE.



Sterile:

The ExEm® Foam Kit FK05 contains a 10ml syringe with 5ml of ExEm® gel, a 10ml syringe with 5ml ExEm® purified water and a coupling device.



Contraindications:
• Do not use the foam during pregnancy.
• Do not use the foam if the patient is suspected to be pregnant/could 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).


Declaration of Conformity