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SELECT IMPORTANT SAFETY INFORMATION
Culture and Retention Devices should not be used in patients with the inability to tolerate
placement or wearing of a device within the vaginal cavity.
Culture and Retention Devices are single use only. Do not use if product or package appears
Do not use Culture Device in patients with hypersensitivity to medical grade silicone or
polystyrene or in patients with a severe case of vaginitis or with a history of toxic shock
syndrome. Evaluate patients for any recent pelvic surgery to assure it will not affect
intravaginal culture procedure.
Proper handling is extremely important to safe and effective use of Culture Device. Do not begin
clinical use of INVOCELL Intravaginal Culture System without establishing competency by reading
and practicing Instructions for Use.
It is recommended that INVOCELL Intravaginal Culture System be utilized with a mild ovarian
stimulation protocol. The recommended upper limit on number of oocytes or ICSI fertilized
embryos to be placed in Culture Device is seven.
Verify Culture Device is correctly locked before placement in vaginal cavity.
Patients should avoid any activity that may alter temperature of vaginal cavity and should avoid
manipulation and removal of Culture and Retention Devices while in place.
Please see the full INVOCELL Intravaginal Culture System Instructions for Use for more
INDICATIONS FOR USE
INVOCELL® Intravaginal Culture System consists of the INVOCELL Culture Device and the INVOCELL
Retention Device. The Culture Device is indicated for use in preparing, holding, and transferring
human gametes or embryos during In Vitro Fertilization/Intravaginal Culture (IVF/IVC) and
Intra-Cytoplasmic Sperm Injection Fertilization/ Intravaginal Culture (ICSI/IVC) procedures. The
Retention Device is indicated for use during the incubation period to aid in retention of the
Culture Device in the vaginal cavity. The Culture and Retention Devices are not indicated for
incubation periods exceeding 72 hours.