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MARA OPERATOR’S MANUAL
MARA OPERATOR’S MANUAL
• Utilize the same settings for delivery of water vapor to each patient,
including time and intrauterine water vapor pressure
• Maintain a nominal intrauterine pressure during water vapor treatment
• Constantly monitor for potential alert conditions and automatically stop
delivery of water vapor to the endometrial cavity accordingly.
The Console monitors the following:
• The elapsed water vapor delivery time
• Cervical temperature
• The intrauterine water vapor pressure
• Internal states and conditions including the triple balloon system
through a variety of checks that are performed throughout the process
that are designed for safety of the patient and user as well as proper
performance
Indication for Use
The Mara Water Vapor Ablation System is indicated to ablate the
endometrial lining of the uterus in premenopausal women with
menorrhagia (excessive uterine bleeding) due to benign causes
for whom childbearing is complete.
Water Vapor Probe and prior to water vapor delivery. The Uterine Cavity
Integrity Test is designed to assess for leaks in the uterus or in the cervical
canal through which water vapor could escape. The Device Lumen Patency
Test is performed directly following a successful Uterine Cavity Integrity
Test. The Device Lumen Patency test is designed to confirm the Water
Vapor Probe tip is positioned appropriately and that the Water Vapor Probe
delivery lumen is not blocked by blood or tissue that could have impacted
the saline flow rate and results of the Integrity Test. Water vapor delivery is
initiated only after both tests pass consecutively.
Water vapor is delivered to the uterus for 140 seconds, with a treatment
time of 120 seconds. The first 20 seconds of water vapor delivery serve to
displace saline remaining in the uterus and device lines after the Device
Lumen Patency Test. These 20 seconds are referred to as the “saline flush.”
Intrauterine water vapor pressure is regulated by the Mara Console, based
on feedback from a pressure sensor near the distal tip of the Water Vapor
Probe. The patient’s uterus will be exposed to a temperature of 101˚C
(nominal) during water vapor delivery.
During treatment, SmartSeal provides automated real-time monitoring
of sealing balloon pressure, uterine pressure and cervical temperature, with
active management of uterine and cervical seals, designed to ensure that
water vapor delivery is confined to the uterine cavity or terminated if a
leak is detected.
The Console is designed to:
• Guide the physician through the procedure by use of a graphical user
interface (GUI)
• Regulate the creation of water vapor in the Water Vapor Probe
• Test the Water Vapor Probe upon connection and preparation for use
• Perform an automated Uterine Cavity Integrity Test designed to assess
for leaks from the uterine cavity before the Device Lumen Patency
Test and delivery of water vapor can be initiated
• Perform an automated Device Lumen Patency Test designed to confirm
the Water Vapor Probe tip is positioned appropriately and that the
Water Vapor Probe delivery lumen is not blocked by blood or tissue that
could have impacted the saline flow rate and results of the Integrity Test
