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MARA OPERATOR’S MANUAL

Mara Console

(MODEL #GEN-16-050)

Mara

™

Water Vapor Ablation System

GEA-SYS-16-0500

Operator’s Manual

Содержание GEA-SYS-16-0500

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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