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MARA OPERATOR’S MANUAL
MARA OPERATOR’S MANUAL
SECTION 1
INTRODUCTION TO MARA WATER VAPOR
ABLATION SYSTEM
System Description
The Mara Water Vapor Ablation System
consists of: (1) a reusable Mara Console
with attached Cartridge and Cartridge
Cable, and AC power cord; and (2) the
single use Mara Water Vapor Probe Kit
that includes a sterile Mara Water Vapor
Probe with attached saline delivery
conduit, syringe and saline supply line
with spiked end.
The single use Mara Water Vapor Probe has been designed with SmartSeal
™
technology to optimize device placement and to protect the cervix and
vagina from thermal effects. The soft slender tip of the Water Vapor Probe
is inserted transcervically into the uterine cavity. The Water Vapor Probe
delivers water vapor to ablate the endometrial lining of the uterus. The water
vapor is created within the Water Vapor Probe from saline, using energy
provided by the Console.
The Mara Water Vapor Ablation System has been designed with the
IntegrityPro™ safety feature which utilizes SmartSeal technology designed
to ensure that the Water Vapor Probe tip is correctly placed in the uterine
cavity and that there are no leaks from the uterine cavity or cervix through
which water vapor could escape. The IntegrityPro safety feature is comprised
of a Uterine Cavity Integrity Test and a Device Lumen Patency Test. Both
tests are performed with normal saline (0.9% NaCl) after placement of the
Read all instructions, cautions and warnings prior to use.
For comprehensive procedural instructions, warnings, precautions and potential
adverse events for the combined use of the Mara Console and the Mara Water Vapor
Probe, please refer to the Mara Water Vapor Ablation System
Instructions for Use
(packaged with the Mara Water Vapor Probe Kit).
Failure to follow any instructions or to heed any warnings or precautions could result in
serious patient injury.
The Mara Water Vapor Probe and Mara Console must be used only in conjunction with
each other. Both are to be used only by physicians who have reviewed and understand the
Mara Water Vapor Ablation System labeling and training materials.
Contact AEGEA Medical with any questions about the information contained in the
Instructions for Use or in the Mara Console Operator’s Manual.
Mara Console and Water
Vapor Probe
CAUTION:
FEDERAL LAW RESTRICTS THIS
DEVICE TO SALE BY OR ON THE ORDER
OF A PHYSICIAN TRAINED IN THE USE
OF THE MARA WATER VAPOR ABLATION
SYSTEM.
