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MARA OPERATOR’S MANUAL

MARA OPERATOR’S MANUAL

Alarms/Alert Codes

The Console provides alerts to inform the user 
of Alarm Conditions and additional Information 
Signals. Table 2 and Table 4 list all alerts. Alert 
Codes 101-199 are Information Signals, while 
Alert Codes 201-299 are Low Priority Alarms. For 
Alarm conditions, the system has determined 
that operator awareness or response may 
be required. Alarms will be accompanied by 
a double-beep tone and solid yellow light. 
Information signals will be accompanied by a 
single beep tone and solid orange light. The 
Alert system is not user adjustable, nor does it 
require user testing to function.

Note:

 The Alarm tones may stutter during 

certain alarm circumstances. This is  
normal for the Console and does not indicate  
a malfunction of the alarm hardware.

Situation

Possible Cause

Solution

Console does not respond 

when turned on

Console is on, but does 

not complete Power On 

Self-Test

Console is on but does not 

deliver output

Console does not advance 

to the next screen after 

inputting passcode

Display exhibits 

interference or is 

unreadable

Water Vapor Probe is in 

the patient and there is no 

power on the Console

Water Vapor Probe is in 

the patient and a Fault 

condition requires turning 

the Console off

Warning light is on (flashing 

orange or flashing orange/

white) with either no 

instructions or the display 

is off

Display is off and the 

Warning light is off, but the 

Front Panel Power Button 

is illuminated

Cartridge is submerged 

in fluid

Water Vapor Probe internal 

balloon inflates outside of 

the uterus during Insertion

1. Check power cord connections 

at wall outlet and Console. 

Connect power cord to 

a functional outlet. Replace 

power cord.

2. Press the rear panel Circuit 

Breaker Reset switch to reset

3. Contact your institution’s 

biomedical department or 

contact an AEGEA Medical

representative

1. Turn Console OFF and then 

back ON 

2. Turn off the unit, contact your 

institution’s biomedical 

department or contact an 

AEGEA Medical representative

1. Follow on-screen prompts for 

guidance. Check the Water 

Vapor Probe connections with 

the Cartridge. Replace Water 

Vapor Probe if necessary (refer 

to Table 3 for steps to 

disconnect and replace the 

Water Vapor Probe).

2. Twist the Interrupt Button to 

disengage

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 Interrupt Button is 

not engaged. Turn Console OFF, 

then back ON, and try again. 

If still unsuccessful, contact an 

AEGEA Medical representative – 

the Console may need to be 

serviced or replaced.

1. Check the power cord for 

damage. Check the power 

outlets for defective grounds. 

2. Turn off the unit. Contact 

your institution’s biomedical 

department or contact an 

AEGEA Medical representative.

Wait 10 seconds for water vapor 

to dissipate from the uterus. 

Disconnect the Cartridge from the 

Water Vapor Probe to deflate the 

Water Vapor Probe’s balloons. 

After 5 seconds, remove the Water 

Vapor Probe from the patient. 
When facility power is restored, 

the Console will automatically 

start. Alerts may appear – 

if so, ensure the Water Vapor 

Probe is disconnected and then 

cycle power. 

Wait 10 seconds for water vapor 

to dissipate from the uterus. 

Disconnect the Cartridge from the 

Water Vapor Probe to deflate the 

Water Vapor Probe’s balloons. 

After 5 seconds, remove the Water 

Vapor Probe from the patient.

Turn off the Console. Contact your 

institution’s biomedical department

or contact an AEGEA Medical 

representative.

Turn off the Console. Contact your 

institution’s biomedical department 

or contact an AEGEA Medical 

representative.

Remove the Cartridge from the 

fluid and shake excess fluids off. 

Repeat with the Cartridge inverted. 
Do not operate until Cartridge is 

fully dry

Do not insert with the internal 

balloon inflated. Press the back 

arrow to deflate the Internal 

balloon and start the insertion 

process again.

1. Disconnected power 

cord, faulty wall 

outlet or faulty power

cord

2. Internal circuit 

breaker switch 

tripped

3. Internal component 

malfunction

1. Software malfunction
2. Internal component 

malfunction

1. Water Vapor Probe 

defective or not 

ready

2. Interrupt Button 

on front panel is 

engaged

3. Internal component 

malfunction

1. User entered wrong 

passcode

2. Console not 

recognizing correct 

passcode

1. Faulty power 

connections 

2. Internal component 

malfunction

Disconnected power 

cord, faulty wall 

outlet, faulty power 

cord, or interruption 

of facility power

Malfunction

Malfunction

Malfunction

Use error

Touchscreen error

Situation

Possible Cause

Solution

Console does not respond 

when turned on

Console is on, but does 

not complete Power On 

Self-Test

Console is on but does not 

deliver output

Console does not advance 

to the next screen after 

inputting passcode

Display exhibits 

interference or is 

unreadable

Water Vapor Probe is in 

the patient and there is no 

power on the Console

Water Vapor Probe is in 

the patient and a Fault 

condition requires turning 

the Console off

Warning light is on (flashing 

orange or flashing orange/

white) with either no 

instructions or the display 

is off

Display is off and the 

Warning light is off, but the 

Front Panel Power Button 

is illuminated

Cartridge is submerged 

in fluid

Water Vapor Probe internal 

balloon inflates outside of 

the uterus during Insertion

1. Check power cord connections 

at wall outlet and Console. 

Connect power cord to 

a functional outlet. Replace 

power cord.

2. Press the rear panel Circuit 

Breaker Reset switch to reset

3. Contact your institution’s 

biomedical department or 

contact an AEGEA Medical

representative

1. Turn Console OFF and then 

back ON 

2. Turn off the unit, contact your 

institution’s biomedical 

department or contact an 

AEGEA Medical representative

1. Follow on-screen prompts for 

guidance. Check the Water 

Vapor Probe connections with 

the Cartridge. Replace Water 

Vapor Probe if necessary (refer 

to Table 3 for steps to 

disconnect and replace the 

Water Vapor Probe).

2. Twist the Interrupt Button to 

disengage

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 Interrupt Button is 

not engaged. Turn Console OFF, 

then back ON, and try again. 

If still unsuccessful, contact an 

AEGEA Medical representative – 

the Console may need to be 

serviced or replaced.

1. Check the power cord for 

damage. Check the power 

outlets for defective grounds. 

2. Turn off the unit. Contact 

your institution’s biomedical 

department or contact an 

AEGEA Medical representative.

Wait 10 seconds for water vapor 

to dissipate from the uterus. 

Disconnect the Cartridge from the 

Water Vapor Probe to deflate the 

Water Vapor Probe’s balloons. 

After 5 seconds, remove the Water 

Vapor Probe from the patient. 
When facility power is restored, 

the Console will automatically 

start. Alerts may appear – 

if so, ensure the Water Vapor 

Probe is disconnected and then 

cycle power. 

Wait 10 seconds for water vapor 

to dissipate from the uterus. 

Disconnect the Cartridge from the 

Water Vapor Probe to deflate the 

Water Vapor Probe’s balloons. 

After 5 seconds, remove the Water 

Vapor Probe from the patient.

Turn off the Console. Contact your 

institution’s biomedical department

or contact an AEGEA Medical 

representative.

Turn off the Console. Contact your 

institution’s biomedical department 

or contact an AEGEA Medical 

representative.

Remove the Cartridge from the 

fluid and shake excess fluids off. 

Repeat with the Cartridge inverted. 
Do not operate until Cartridge is 

fully dry

Do not insert with the internal 

balloon inflated. Press the back 

arrow to deflate the Internal 

balloon and start the insertion 

process again.

1. Disconnected power 

cord, faulty wall 

outlet or faulty power

cord

2. Internal circuit 

breaker switch 

tripped

3. Internal component 

malfunction

1. Software malfunction
2. Internal component 

malfunction

1. Water Vapor Probe 

defective or not 

ready

2. Interrupt Button 

on front panel is 

engaged

3. Internal component 

malfunction

1. User entered wrong 

passcode

2. Console not 

recognizing correct 

passcode

1. Faulty power 

connections 

2. Internal component 

malfunction

Disconnected power 

cord, faulty wall 

outlet, faulty power 

cord, or interruption 

of facility power

Malfunction

Malfunction

Malfunction

Use error

Touchscreen error

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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