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16

MARA OPERATOR’S MANUAL

17

MARA OPERATOR’S MANUAL

•  Orange (solid) – Alert 

(Information Signals). Clear  
the message and continue  
the procedure.

•  Off (default)
•  Green – Ready for Treatment
•  Blue – Water Vapor Treatment

7.  Enter the device-specific passcode 

to continue 

(image 2)

.

8.  Prepare the Water Vapor Probe 

following standard aseptic 
procedures to maintain sterility 
of the Water Vapor Probe, while 
passing the Syringe with attached 
tubing out of the sterile field for 
connection to the Console.

 

Warning:

 Aseptic technique –  

Use aseptic technique in all patient 
procedures.

9.  Firmly insert and rotate the Syringe 

clockwise to engage it in the  
Syringe Port on the top of the 
Console 

(images 3 and 4)

. Syringe 

will illuminate green to indicate 
proper insertion.

10.  Spike the saline bag with the Saline 

Supply line. Ensure the pole for the 
Saline Bag is locked in the upright 
position, and hang the Saline Bag on 
the Saline Supply Hook 

(image 5)

.

Note:

 If the self-test is unsuccessful, 

an alarm tone will sound and an alert 
number will appear on the display. 
The Console will be disabled and will 
require the power to be turned OFF. 
Refer to the Troubleshooting Guide in 
Section 5 for more information about 
alert numbers.

f.  The display transitions to the “IFU” 

screen at the completion of the power 
on self-test. Refer to #8 on the  
next page.

Note:

 The display allows adjustment  

of the speaker volume. Press the “gear” 
symbol and select volume, if desired. 

Note:

 The Graphical User Interface 

Display will provide instructions  
and guidance to assist with 
performance of the procedure. It  
is also a touch screen to allow the  
user to respond to prompts and  
to control the procedure. 

Note:

 There is a Warning Light above 

the display that will illuminate to 
indicate different status conditions,  
as follows:

•  Orange (flashing) – Fault. Turn off  

the Console.

•  Yellow (solid) – Alert (Alarm 

Condition). Follow instructions and 
continue the procedure.

Image 1

Image 2

Image 4

Image 3

Summary of Contents for GEA-SYS-16-0500

Page 1: ...1 MARA OPERATOR S MANUAL Mara Console MODEL GEN 16 050 Mara Water Vapor Ablation System GEA SYS 16 0500 Operator s Manual...

Page 2: ...ation 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: ...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...

Page 4: ...e 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...

Page 5: ...rapy for asthma A patient with a uterine length 6cm external cervical ostium to internal fundus A patient with a history of a prior completed endometrial ablation procedure and or endometrial resectio...

Page 6: ...tand the Instructions For Use Mara Console Operators Manual Indications Contraindications Warnings Technical Warnings and Precautions supplied with the Mara Water Vapor Ablation System Be able to main...

Page 7: ...the on screen prompts to test the Water Vapor Probe The system is ready for use Follow the instructions in the Mara Water Vapor Ablation System Instructions for Use and on the Console display Proceed...

Page 8: ...eaker is functional e The Console self test power on self test successfully completes a status bar will show progression of the power on self test Setup Instructions If the Console was transported or...

Page 9: ...n and hang the Saline Bag on the Saline Supply Hook image 5 Note If the self test is unsuccessful an alarm tone will sound and an alert number will appear on the display The Console will be disabled a...

Page 10: ...o disconnect and replace the Water Vapor Probe In addition to the balloon inflation test the Console will test the intrauterine pressure sensor and the saline flow system Warning During the Water Vapo...

Page 11: ...er Vapor Probe Power on the Console and continue using a new Water Vapor Probe For service contact information refer to back of Operator s Manual Malfunctions Should the Console malfunction return to...

Page 12: ...ngage 3 Turn off the unit Contact your institution s biomedical department or contact an AEGEA Medical representative 1 Contact an AEGEA Medical representative for the correct passcode 2 Ensure the In...

Page 13: ...not insert with the internal balloon inflated Press the back arrow to deflate the Internal balloon and start the insertion process again Malfunction Malfunction Malfunction Use error Touchscreen erro...

Page 14: ...he Protective Tip Cover is properly installed on the Water Vapor Probe Check that the Cartridge Cable is not impinged or pressed against any objects Clear error message s If the issue persists refer t...

Page 15: ...ame Description Action Syringe Unloaded External Balloon Inflation Too Slow External Balloon Leak Middle Balloon Leak 130 140 141 142 The Console has detected that the Syringe was unexpectedly release...

Page 16: ...robe Handle before removing the Water Vapor Probe from the patient If the issue persists turn off the Console and contact an AEGEA representative Alert Code Name Description Action Air Reservoir Press...

Page 17: ...e 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 repres...

Page 18: ...abilize to the room temperature environment If this issue persists contact an AEGEA Medical representative Alert Code Name Description Action Saline Pump Over extended Pressure Sensor Calibration Does...

Page 19: ...o 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 Alert Code Name Description A...

Page 20: ...and contact an AEGEA Medical representative Alert Code Name Description Action Interrupt Button Engaged Cervical Temperature Greater Than Expected Body Temperature Cervical Thermocouple Circuit Fault...

Page 21: ...stopped and treatment has terminated early Press Clear wait 10 seconds and then remove the Water Vapor Probe from the patient Alert Code Name Description Action Middle Balloon Leak Internal Balloon Le...

Page 22: ...reatment has ended Press Clear wait 10 seconds and remove the Water Vapor Probe from the patient The Console has detected that the intrauterine pressure measurement function is not operational Water v...

Page 23: ...ld not attempt to access the inside of the Console or open the Service Door The Console is not provided with networking capabilities Returning the Console for Service Before returning the Console cont...

Page 24: ...panels or damage the Console Use common hospital cleaning solutions such as 70 Alcohol 3 Hydrogen Peroxide Solution 10 Bleach Solution Do not allow cleaning fluids to enter the Console or Cartridge C...

Page 25: ...etic mixture with air or with oxygen or nitrous oxide The Console needs special precautions regarding EMC Electromagnetic Compatibility and needs to be installed and put into service according to the...

Page 26: ...e user of the GEA SYS 16 0500 requires continued operation during power mains interruptions it is recommended that the GEA SYS 16 0500 be powered from an uninterruptible power supply or a battery Powe...

Page 27: ...ipherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the GEA SYS 16 0500 including cables Field strengths from fixed RF transmitters as de...

Page 28: ...54 55 MARA OPERATOR S MANUAL MARA OPERATOR S MANUAL APPENDIX B DISPLAY SCREENS Screen 03 Screen 04 Screen 05 Screen 09 Screen 10 Screen 11 Screen 12 Screen 13 Screen 14 Screen 06 Screen 07 Screen 08...

Page 29: ...ARA OPERATOR S MANUAL MARA OPERATOR S MANUAL Screen 15 Integrity Screen 15 Patency Screen 16 Integrity Screen 19 Treatment Screen 20 Screen 21 Screen 22 Screen 25 Screen 16 Patency Screen 18 Screen 19...

Page 30: ...ate of Manufacture Manufacturer Power On Off Alternating Current Shock Protection Type B S Protective Earth Terminal Temperature Limit Humidity Limitation Atmospheric Pressure Limitation Consult Instr...

Page 31: ...60 MARA OPERATOR S MANUAL AEGEA Medical Inc 4055 A Campbell Avenue Menlo Park CA 94025 USA Phone 1 650 701 1125 Fax 1 650 701 1126 AW0249 01 06 2020...

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