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MARA OPERATOR’S MANUAL

MARA OPERATOR’S MANUAL

Table A2

Guidance and Manufacturer’s Declaration (Electromagnetic Immunity)

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 

such an environment.

Immunity

Test

IEC 60601

Test Level

Compliance

Level

Electromagnetic

Environment – Guidance

Electrostatic 

Discharge (ESD)

IEC 61000-4-2

Electrical Fast 

Transient/Burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage Dips, 

Short 

Interruptions 

and Voltage 

Variations on 

Power Supply 

Input Lines

IEC 61000-4-11

(60 Hz) Magnetic 

Field

IEC 61000-4-8

±8 kV contact

±2, ±4, ±8, ±15 kV 

air

±2 kV for power 

supply lines
±1 kV for 

input/output lines

±1 kV differential 

mode
±2 kV common 

mode

<5% 110 or 230 VAC 

(>95% dip in 110 or 

230 VAC) for 0.5 

cycle
<5% 110 or 230 VAC 

(>95% dip in 110 or 

120 VAC) for 1 cycle
70% 110 or 230 VAC 

(30% dip in 110 or 

230 VAC) for 0.5 sec
<5% 110 or 230 VAC 

(>95% dip in 110 or 

230 VAC) for 5 sec

30 A/m

±8 kV contact

±2, ±4, ±8, ±15 kV 

air

±2 kV for power 

supply lines
Not Applicable

±1 kV differential 

mode
±2 kV common 

mode

<5% 110 or 230 VAC 

(>95% dip in 110 or 

230 VAC) for 0.5 

cycle
<5% 110 or 230 VAC 

(>95% dip in 110 or 

230 VAC) for 1 cycle
70% 110 or 230 VAC 

(30% dip in 110 or 

230 VAC) for 0.5 sec
<5% 110 or 230 VAC 

(>95% dip in 110 or 

230 VAC) for 5 sec

30 A/m

Floors should be wood, 

concrete or ceramic tile. 

If floors are covered with 

synthetic material, the 

relative humidity should 

be at least 30%.

Mains power quality 

should be that of a typical 

commercial or hospital 

environment.

Mains power quality 

should be that of a typical 

commercial or hospital 

environment.

Mains power quality 

should be that of a typical 

commercial or hospital 

environment. If the 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.

Power frequency magnetic 

fields should be at levels 

characteristic of a typical 

location in a typical 

commercial or hospital 

environment.

Guidance and Manufacturer’s Declaration (Electromagnetic Immunity)

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 

such an environment.

Proximity Fields 

from RF Wireless 

Communications

IEC 61000-4-3

385 MHz at 27 V/m, 

Pulse 18 Hz
450 MHz at 28 V/m, 

FM ± 5kHz, 

Deviation 1 kHz sine
710 MHz at 9 V/m, 

Pulse 217 Hz
745 MHz at 9 V/m, 

Pulse 217 Hz
780 MHz at 9 V/m, 

Pulse 217 Hz
810 MHz at 28 

V/mPulse 18Hz
870 MHz at 28 V/m, 

Pulse 18 Hz
930 MHz at 28 V/m, 

Pulse 18 Hz
1720 MHz at 28 V/m, 

Pulse 217Hz
1845 MHz at 28 V/m, 

Pulse 217 Hz
1970 MHz at 28 V/m, 

Pulse 217 Hz
2450 MHz at 28 V/m, 

Pulse 217 Hz
5240 MHz at 9 V/m, 

Pulse 217 Hz
5500 MHz at 9 V/m, 

Pulse 217 Hz
5785 MHz at 9 V/m, 

Pulse 217 Hz

385 MHz at 27 V/m, 

Pulse 18 Hz
450 MHz at 28 V/m, 

FM ± 5kHz, 

Deviation 1 kHz sine
710 MHz at 9 V/m, 

Pulse 217 Hz
745 MHz at 9 V/m, 

Pulse 217 Hz
780 MHz at 9 V/m, 

Pulse 217 Hz
810 MHz at 28 

V/mPulse 18Hz
870 MHz at 28 V/m, 

Pulse 18 Hz
930 MHz at 28 V/m, 

Pulse 18 Hz
1720 MHz at 28 V/m, 

Pulse 217Hz
1845 MHz at 28 V/m, 

Pulse 217 Hz
1970 MHz at 28 V/m, 

Pulse 217 Hz
2450 MHz at 28 V/m, 

Pulse 217 Hz
5240 MHz at 9 V/m, 

Pulse 217 Hz
5500 MHz at 9 V/m, 

Pulse 217 Hz
5785 MHz at 9 V/m, 

Pulse 217 Hz

Portable and mobile RF 

communications 

equipment (including 

peripherals 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 

than 30 cm (12 inches), 

including cables.

Immunity

Test

IEC 60601

Test Level

Compliance

Level

Electromagnetic

Environment – Guidance

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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