Summary of Contents for Mara GEA-SYS-16-0500
- Page 1 Mara Water Vapor Ablation System ™ GEA-SYS-16-0500 Operator’s Manual Mara Console (MODEL #GEN-16-050) MARA OPERATOR’S MANUAL...
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Page 2: Table Of Contents
TABLE OF CONTENTS SECTION 1 Introduction to Mara Water Vapor Ablation System ............5 SECTION 2 Controls, Indicators and Receptacles ....................9 SECTION 3 Preparing the Console for Use ......................11 SECTION 4 After the Procedure ............................. 20 SECTION 5 Troubleshooting ...............................21 SECTION 6 Maintenance and Repair ......................... -
Page 3: Introduction To Mara Water Vapor Ablation System
For comprehensive procedural instructions, warnings, precautions and potential vapor is created within the Water Vapor Probe from saline, using energy adverse events for the combined use of the Mara Console and the Mara Water Vapor provided by the Console. Probe, please refer to the Mara Water Vapor Ablation System Instructions for Use (packaged with the Mara Water Vapor Probe Kit). - Page 4 Lumen Patency Test. These 20 seconds are referred to as the “saline flush.” through a variety of checks that are performed throughout the process Intrauterine water vapor pressure is regulated by the Mara Console, based that are designed for safety of the patient and user as well as proper...
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Page 5: Controls, Indicators And Receptacles
SECTION 2 Contraindications CONTROLS, INDICATORS AND RECEPTACLES The Mara Water Vapor Ablation System is contraindicated for use in: • A patient who is pregnant or who wants to become pregnant in the future PREGNANCIES FOLLOWING ABLATION CAN BE DANGEROUS FOR BOTH MOTHER AND FETUS •... -
Page 6: Preparing The Console For Use
Clinical Use Checklist 10. Saline Supply Hook Prior to use of the Mara Water Vapor Ablation System on a patient, the 11. Power Cord Receptacle physician should complete the following checklist to better ensure a safe and effective use of the system. Note that this is not a comprehensive 12. - Page 7 Quick Setup Instructions Refer to the Mara Water Vapor Ablation System IFU for additional Warnings. If you are familiar with the Mara Console, you may prefer to follow these abbreviated instructions. Otherwise, use the detailed instructions that The Console is not packaged as sterile.
- Page 8 The light above the display temporarily illuminates used no closer than 30 cm (12 inches) to any part of the Mara Water Vapor Ablation System, including cables specified by AEGEA Medical c.
- Page 9 Supply line. Ensure the pole for the Saline Bag is locked in the upright • Yellow (solid) – Alert (Alarm position, and hang the Saline Bag on Condition). Follow instructions and the Saline Supply Hook (image 5). continue the procedure. MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL...
- Page 10 12. Pull down on the Blue Tab at the base of the Water Vapor Probe Handle to pull the Sterile Sheath over the Cartridge Cable (image 7). MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL...
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Page 11: After The Procedure
Water Vapor Probe. Power on the the back of the Console. Store the Console and continue using a new power cord with the Console. Water Vapor Probe. For service contact information, refer to back of Operator’s Manual. MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL... - Page 12 Turn off the Console. Contact your AEGEA Medical representative – AEGEA Medical representative – orange or flashing orange/ institution’s biomedical department MARA OPERATOR’S MANUAL the Console may need to be MARA OPERATOR’S MANUAL the Console may need to be white) with either no or contact an AEGEA Medical serviced or replaced.
- Page 13 ON, and try again. If still unsuccessful, contact an AEGEA Medical representative – the Console may need to be serviced or replaced. MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL Display exhibits 1. Faulty power 1. Check the power cord for...
- Page 14 • Check that the Cartridge Cable is not impinged or pressed against any objects • Clear error message(s) • If the issue persists, refer to Table 3 for instructions to disconnect and reconnect/replace the Water Vapor Probe from the Cartridge MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL...
- Page 15 • Ensure that the Cartridge is firmly connected to the Water Vapor Probe and is not leaking • Clear error message(s) • If the issue persists, refer to Table 3 for instructions to disconnect and reconnect/replace the Water Vapor Probe from the Cartridge MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL...
- Page 16 • If the issue persists, refer to Table 3 for instructions to the patient disconnect and reconnect/replace the Water Vapor • If the issue persists, turn off the Console and contact an Probe from the Cartridge AEGEA representative MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL...
- Page 17 • Note: If the Water Vapor Probe is within the cervix, disconnect the Cartridge from the Water Vapor Probe before removing the Water Vapor Probe from the patient • If the issue persists, turn off the Console and contact an AEGEA representative MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL...
- Page 18 • Retry operation or power-cycle Console • If this issue persists, contact an AEGEA Medical representative • If the issue persists, consider replacing the Console. Contact an AEGEA Medical representative. MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL...
- Page 19 Water Vapor Probe from the Cartridge • Clear error message(s) • If the issue persists, refer to Table 3 for instructions to disconnect and reconnect/replace the Water Vapor Probe from the Cartridge MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL...
- Page 20 • If the issue persists, turn off the Console and contact an • Water vapor delivery has stopped and treatment has AEGEA Medical representative terminated early. Press “Clear” and prepare to remove the Water Vapor Probe from the patient MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL...
- Page 21 A second vapor treatment in the same operative setting must not be attempted for this patient. A repeat ablation with the Mara Water Vapor Ablation System has not been studied and Vapor Probe The Cartridge has become detached from the Water Vapor the effects are unknown.
- Page 22 8. Follow on-screen instructions Interrupt While The Console has detected that the Interrupt button has been Treating activated during treatment. • Twist the Interrupt button on the front of the Console to Release the button MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL...
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Page 23: Maintenance And Repair
Service Before returning the Console, contact your AEGEA Medical representative for assistance. If you are instructed to send the Console back to AEGEA Medical, you will be issued a Return Material Authorization (RMA) Number. MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL... -
Page 24: Appendix A Technical Description
If the Console was stored for longer than one year, the Console should be tested and calibrated before use. Duty Cycle Continuous with Intermittent operation (3 min on / 7 min off) during water vapor delivery. MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL... - Page 25 Audible tone volume is adjustable on the first screen. However, audible The GEA-SYS-16-0500 is intended for use in the electromagnetic environment specified tones for Alarms are not adjustable. below. The customer or the user of the GEA-SYS-16-0500 should assure that it is used in such an environment. ⚠...
- Page 26 The GEA-SYS-16-0500 is intended for use in the electromagnetic environment specified below. The customer or the user of the GEA-SYS-16-0500 should assure that it is used in below. The customer or the user of the GEA-SYS-16-0500 should assure that it is used in such an environment.
- Page 27 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the GEA-SYS-16-0500 is used exceeds the applicable RF compliance level above, the GEA-SYS-16-0500 should be observed to verify normal operation.
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Page 28: Appendix B Display Screens
APPENDIX B: DISPLAY SCREENS Screen 03 Screen 04 Screen 05 Screen 09 Screen 10 Screen 11 Screen 06 Screen 07 Screen 08 Screen 12 Screen 13 Screen 14 MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL... - Page 29 Screen 15 (Integrity) Screen 15 (Patency) Screen 16 (Integrity) Screen 19 (Treatment) Screen 20 Screen 21 Screen 16 (Patency) Screen 18 Screen 19 (Flush) Screen 22 Screen 25 MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL...
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Page 30: Symbol Definitions On Labeling
Use by Date Do Not Dispose Date of Manufacture Outflow Conduit Warning Manufacturer Protects persons against access to hazardous parts with fingers; protection Power On/Off against vertically falling water drops Alternating Current Shock Protection Type B MARA OPERATOR’S MANUAL MARA OPERATOR’S MANUAL... - Page 31 AEGEA Medical Inc. 4055-A Campbell Avenue Menlo Park, CA 94025 Phone: +1 (650) 701-1125 AW0249.01 Fax: +1 (650) 701-1126 06/2020 MARA OPERATOR’S MANUAL...
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