Exem Foam Kit

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.
Do not re-sterilize.
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 purified water, the 20 ml syringe
and/or the coupling device.
Do not use the ExEm® gel and the purified water separately for Hysterosalpingo Sonography.
The ExEm® gel and the purified water are not to be used for injections.

STERILE unless package has been opened or damaged.

FOR SINGLE USE ONLY. DO NOT REUSE.

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Sterile:
The ExEm® Foam-kit contains the following sterile products with Œ markings:
Farco-Pharma 10 ml syringe with ExEm® gel
Farco-Pharma 10 ml syringe with purified water
NIPRO 20 ml syringe
Infumed coupling device

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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).

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Letter to the Editor - You have full text access to this OnlineOpen article

Hysterosalpingo-Foam Sonography (HyFoSy): a new technique to visualize tubal patency

• Mark Hans Emanuel1*,
• Niek Exalto2

DOI: 10.1002/uog.8912
Copyright © 2010 ISUOG. Published by John Wiley & Sons, Ltd.
Issue Ultrasound in Obstetrics & Gynecology
Accepted Article (Accepted, unedited articles published online for future issues)

Hystersalpingo Foam Sonography Poster (PDF)

Conference Presentation RCOG 2010 (PDF)

Declaration of Conformity

Encl 1_BC_CE Declaration of Conformity ExEm gel
Encl 2_BC_CE Declaration of Conformity syringes purified water for diilutionof ExEm gel
Encl 3_BC_CE Declaration of Conformity - TPC - Syringe without needle - rev12 (Terumo)
Encl 4_BC_CE Declaration of Conformity Couplers 100526
Encl 5_BC_EC Directive 93 42 EEC certificate-1270634799 Gynetics GIS catheter
Encl 6_BC ref1_Collins et al_Fertil Steril
Encl 7_BC ref2_Snick et al_Human Reprod
Encl 8_BC ref3_Spalding et al_Human Reprod
Encl 9_BC ref5_Werbrouck abstract
Encl 10_BC ref6_ASRM Emanuel P-109
Encl 10_BC ref7_Emanuel abstract GIS vs SIS
WHO HIV prevention study with placebo (PDF)
A 'non perturbing' Placebo (PDF)