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AEX™ Generator
Planned
Maintenance Manual
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Copyright © 2021 Medtronic. All rights reserved.
No part of this documentation may be reproduced in any form or by any means or used to make any derivative
work (such as translation, transformation, or adaptation) without written permission from Medtronic.
The information contained in this document is accurate at time of publication. Medtronic reserves the right to
revise this documentation and to make any changes in content from time to time without obligation on the part
of Medtronic to provide notification of such revision or change.
Medtronic provides this documentation without warranty, term, or condition of any kind, either implied or
expressed, including, but not limited to, the implied warranties, terms or conditions of merchantability,
satisfactory quality, and fitness for a particular purpose. Medtronic may make improvements or changes in the
product(s) and/or the program(s) described in this documentation at any time.
No part of this document may be reproduced in any manner, or transmitted by any form or means electronic or
mechanical, for any purpose without the express written permission of Medtronic.
Rx Only: Federal Law (USA) restricts these devices to sale by or on the order of a physician.
For a listing of indications, contraindications, precautions, and warnings, please refer to the Instructions For
Use (IFU) that accompany the Medtronic disposable devices and/or the AEX™ Generator Operator’s Manual.
Aquamantys™, PlasmaBlade™, PlasmaBlade™ X and AEX™ are registered trademarks of Medtronic. All
other product names are the property of their respective owners.
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Table of Contents
Introduction 4
About this manual 4
Conventions used in this manual 4
Warnings and cautions 4
Notes 4
Related documents 4
Technical support contact information 5
Within the United States 5
International 5
World Wide Web 5
AEX™ Generator Planned Maintenance 6
Maintenance Procedures 8
Routine Maintenance 8
Leakage currents and protective earth conductor test 8
RF Output Power Accuracy Verification 10
Bipolar power output test with Aquamantys™ (3-pin) 10
Monopolar power output test with PlasmaBlade™ X (7-pin) 11
Peristaltic pump test 13
Cleaning 13
Responsibility of the Manufacturer 14
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Introduction
About this manual
Use of this manual
This manual describes the planned maintenance of the Medtronic AEX™ Generator.
Use this manual when completing planned maintenance on an AEX™ Generator. The procedures in this
manual are not intended for any other system.
The information in this manual is current as of the revision date shown on the back cover.
Important: When performing any planned maintenance activity, read the complete step including any
admonitions and additional information before attempting to complete the instruction.
Warning: The information contained in this document is intended for the use of qualified personnel
only. Biomedical technicians (e.g., ICC Certified Biomedical Equipment Technician
[BMET]) or similar personnel performing the steps outlined here shall be fully familiar with
all documentation on the functions, operations, warnings and components of the AEX™
Generator. Serious injury can result if the activities described in this document are
attempted by unqualified persons.
Conventions used in this manual
Warnings and cautions
Warning: Failure to observe a warning may result in physical injury to the patient or operator. Pay
special attention to these items.
Caution: Failure to observe a caution could result in damaged equipment, forfeited time or effort, or
the need to stop the use of the system.
Notes
Note: Notes identify important points, helpful hints, special circumstances, or alternative
methods.
Related documents
• AEX™ Generator Operator Manual
• Electrical Safety Analyzer Manual (site-specific equipment)
• Electrosurgical Analyzer (ESA) Operator Manual (site-specific equipment)
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Introduction | Technical support contact information
Technical support contact information
Within the United States
Phone
Toll-free dial: +18005959709
Regular mail
Medtronic
Attn: Technical Services
826 Coal Creek Circle
Louisville, CO 80027, U.S.A.
International
Phone
Telephone: +17208903160
World Wide Web
Medtronic authorized representative in the E.C.
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
Netherlands
Telephone 31 45 566 80 00
www.manuals.medtronic.com
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AEX™ Generator Planned Maintenance
The AEX™Generator provides radio frequency (RF) energy to a disposable electrosurgical device. This
combined system is used to perform electrosurgery. The Generator is capable of delivering multiple CUT,
COAG and Transcollation™modes at various power levels when connected to a disposable device. The
7-pin disposable devices have a memory chip with predetermined set points. See individual device user
manuals for specific information. This chip specifies the output power for each set point. The generator
reads this 7-pin device memory chip to deliver RF power. The 3-pin devices do not have a memory chip.
Figure1.System Component Interface Diagram
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AEX™ Generator Planned Maintenance | AEX™ Generator Planned Maintenance
Required qualifications to perform these procedures
Only biomedical technicians with electrical expertise are qualified to complete these procedures.
Required Safety Equipment
• Wear-Indicating Electrical-Protection Gloves, Class 1 ASTM Voltage Rating
• Safety glasses
Required Equipment
The following equipment is required to complete the output power accuracy testing:
• AEX™Generator
• A neutral electrode (return pad) connector with the pad cut off and the two leads shorted together
• Disposable device
– 3-pin: Aquamantys™6.0 or MBS
– 7-pin: PlasmaBlade™ X 3.0S or 4.0
• Two test leads with alligator clips on one end and a 4 mm banana plug on the other end
• Electrosurgical analyzer (ESA) capable of measuring RF output at 469 KHz, and ESA user guide
• Safety tester and safety tester user guide for medical units as per IEC #60601
Required Annual Inspections
1. Visually inspect the AEX™ Generator for physical damage. Report damage to Medtronic or
your biomedical department. Do not use the AEX™ Generator if it is damaged.
2. Visually inspect the power cord and plug for physical damage. Replace the cord if the
insulation has been breached.
Do not use the Generator if the cord or plug has been damaged and has not yet been
replaced.
3. Inspect the fit of the cord to the AEX.
If the AEX™ Generator receptacle is damaged or loose, return the Generator to
Medtronic for repair.
4. Inspect the mating, cleanliness, and absence of damage to the patient connectors. Do not
use the AEX™ Generator if the connectors are damaged.
5. Inspect for accumulation of lint or debris within the AEX™Generator or fan vents. Do not
use the AEX™ Generator if lint or debris has accumulated and has not been cleared.
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Maintenance Procedures
This section contains information about routine maintenance.
Warning: Do not modify this equipment. Only authorized Medtronic service technicians may make
modifications to the AEX™Generator.
Routine Maintenance
Required qualifications to perform these procedures
Only biomedical technicians with electrical expertise are qualified to complete these procedures.
Recommended Periodic Functional Verification
The AEX™ Generator should be periodically checked for functionality and performance according to the
hospital equipment servicing guidelines. Medtronic recommends that the unit’s calibration be verified and
a safety check be performed by a qualified biomedical technician on an annual basis as outlined in this
document. Reference the ESA Manual for specific instructions for safety tests.
Recommended Functional Verification Procedure
The verification and functional check should include:
• Protective earth conductor test
• Earth leakage current measurement (page 8)
• Housing leakage current measurement
• Output power accuracy verification (page 10 and page 11)
• Peristaltic pump test (page 13)
• Power cord inspection (for damage)
• Fuse check (if the system will not start)
Caution: Frequent opening of the fuse compartment can damage the plastic housing. Use care
when the fuse compartment must be opened to avoid damage to the housing. Only check
the fuses if the system will not power on.
Leakage currents and protective earth conductor test
Required Safety Equipment
• Wear-Indicating Electrical-Protection Gloves, Class 1 ASTM Voltage Rating
• Safety glasses
Make the following connections according to Safety Analyzer instructions and diagram for CF-type
equipment:
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Maintenance Procedures | Leakage currents and protective earth conductor test
• Male end of AEX™Generator’s power cord into the safety tester mains socket
• The AEX™equipotential bonding terminal (see AEX™Operator’s Manual) to safety tester
impedance measurement terminal
Perform leakage and PE conductor tests per the user guide of the ESA.
• Table 1 shows leakage current and PE conductor limits that are compliant with IEC #60601 (Class
I, Type CF device).
• Refer to the user manuals of testing equipment used for leakage current and protective earth
conductor testing.
Table 1. Leakage current and PE conductor limits
Measured Characteristic Maximum Value
PE conductor impedance 0.2Ω
Earth leakage current, normal condition 500µA
Earth leakage current, single fault condition 1000µA
Housing or touch leakage current, normal condition 100µA
Housing or touch leakage current, single fault condition 500µA
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Maintenance Procedures | RF Output Power Accuracy Verification
RF Output Power Accuracy Verification
Warning: External load resistors used to test the output of the AEX™Generator will become
extremely hot. Use extreme caution to avoid any contact. All load resistors must be
properly mounted and isolated from any flammable materials.
Caution: The ESA must have a current rating of at least 2.5 Arms. Do not test the AEX™Generator
with a load of less than 50 ohms on the output, or RF currents in excess of 2.5 amps RMS
will occur.
Required qualifications to perform these procedures
Only biomedical technicians with electrical expertise are qualified to complete these procedures.
Bipolar power output test with Aquamantys™ (3-pin)
Required Safety Equipment
• Wear-Indicating Electrical-Protection Gloves, Class 1 ASTM Voltage Rating
• Safety glasses
Use Aquamantys™ (3-pin) 6.0 mm disposable electrodes.
1. Attach the alligator clip of each lead to the bipolar electrodes.
Caution: Do not let the clips touch. If the clips touch, they will create a short, and there
will not be enough output for an accurate test.
2. Attach the banana plug to the ESA.
3. Test the RF output at the 20 watt, 110 watt, and 220 watt settings with the output loaded at
100 ohms, Table 2.
The measured RF output power should be equal to the set power ±20%.
Note: Prime must be performed before 3-pin device can activate. Prime can be performed without
the tubing inserted into pump.
Note: Priming the pump is loud.
Table 2. AEX™ Power output specs for 3-pin device
Setting Power (Watts) Impedance (Ohms) Tolerance
20W 20W 100 ± 20% (16–24)
110W 110W 100 ± 20% (88–132)
220W 220W 100 ± 20% (176–264)
Contact Medtronic technical support at +18005959709 for further assistance.
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Maintenance Procedures | Monopolar power output test with PlasmaBlade™ X (7-pin)
Testing failure
If bipolar testing fails, confirm that the alligator clips are placed one clip per lead and not touching. Test
again.
If the test still fails, contact Medtronic technical support at +18005959709.
Monopolar power output test with PlasmaBlade™ X (7-pin)
Required Safety Equipment
• Wear-Indicating Electrical-Protection Gloves, Class 1 ASTM Voltage Rating
• Safety glasses
The monopolar power output test verifies the accuracy of the RF energy output.
Table 3 shows the minimum number of settings to test for accuracy. Table 4 shows an expanded list of
settings for hospitals that require it.
1. Connect the 7-pin device to the AEX generator.
2. Connect the tip of the PlasmaBlade™ X 7-pin device to the ESA leads using an alligator
clip.
Caution: Attach the alligator clip to the metal edge of the blade. Other parts are isolated
and will not work.
3. Connect the shorted leads of the neutral electrode to the ESA leads using an alligator clip.
4. Set the load on the ESA to the value indicated in Table 3 or Table 4.
Refer to the ESA Instruction manual for set up instructions.
5. Power on the generator and adjust to the appropriate set point in Table 3 or Table 4.
6. Press the button (yellow for CUT and blue for COAG) on the PlasmaBlade™ X device to
activate RF.
Measure the output power on the ESA.
Refer to Table 3 or Table 4 for accuracy of measured power depending on the type of
device connected.
7. Repeat step 1 through step 6 for the settings in Table 3 or Table 4.
Table 3. Minimum AEX™ Power Output Specs for PlasmaBlade™ X (7-pin)
Setting Mode Power (Watts) Impedance (Ohms) Tolerance
Cut 8 Medium Cut 50 500 40.0–60.0
Cut 10 High Cut (Blend 2) 50 500 40.0–60.0
Coag 5 Low Coag 35 500 28.0–42.0
Coag 8 High Coag 40 1000 32.0–48.0
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Maintenance Procedures | Monopolar power output test with PlasmaBlade™ X (7-pin)
Table 4. Expanded AEX™ Power Output Specs for PlasmaBlade™ X (7-pin)
Setting Mode Power (Watts) Impedance (Ohms) Tolerance
Cut 1 Low Cut 0.5 100 0.0–1.7
Cut 2 Low Cut 2.0 100 1.0–3.0
Cut 3 Low Cut 6 100 3.8–6.1
Cut 4 Low Cut 10 100 8.0–12.0
Cut 5 Low Cut 20 100 16.0–24.0
Cut 6 Medium Cut 20 500 16.0–24.0
Cut 7 Medium Cut 35 500 28.0–42.0
Cut 8 Medium Cut 50 500 40.0–60.0
Cut 9 High Cut (Blend 1) 25 500 20.0–30.0
Cut 10 High Cut (Blend 2) 50 500 40.0–60.0
Coag 1 Low Coag 15 500 12.0–18.0
Coag 2 Low Coag 20 500 16.0–24.0
Coag 3 Low Coag 25 500 20.0–30.0
Coag 4 Low Coag 30 500 24.0–36.0
Coag 5 Low Coag 35 500 28.0–42.0
Coag 6 High Coag 30 1000 24.0–36.0
Coag 7 High Coag 35 1000 28.0–42.0
Coag 8 High Coag 40 1000 32.0–48.0
Coag 9 High Coag 45 1000 36.0–54.0
Coag 10 High Coag 50 1000 40.0–60.0
Contact Medtronic technical support at +18005959709 for further assistance.
Testing failure
If monopolar testing fails, confirm that the alligator clips on the monopolar device is clipped to the edges of
the blade, not the flat part of the blade. Test again.
If the test still fails, contact Medtronic technical support at +18005959709.
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Maintenance Procedures | Peristaltic pump test
Peristaltic pump test
Required Safety Equipment
• Wear-Indicating Electrical-Protection Gloves, Class 1 ASTM Voltage Rating
• Safety glasses
Prime test
1. Power on the AEX™ Generator.
2. Plug the Aquamantys™ 3-pin device into the front panel connector of the AEX™ Generator.
3. Adjust the seal power to 100 Watts.
4. Open the pump head so that the rollers are visible.
5. Activate the prime function and observe the speed of the pump
The rollers should move fast for a maximum of 19 seconds, then stop.
High speed test
6. Adjust the flow setting on the generator to high (3 drops).
7. Activate RF using the Aquamantys ™ 3-pin device.
The pump speed must be slower than the prime speed.
8. Deactivate RF.
Cleaning
Medium speed test
9. Adjust the flow setting on the generator to medium (2 drops).
10. Activate RF using the 3-pin device.
Pump speed must be slower than high speed.
11. Deactivate RF.
Low speed test
12. Adjust the flow setting on the generator to slow (1 drop).
13. Activate RF using the Aquamantys™ 3-pin device.
The pump speed must be slower than medium speed.
14. Deactivate RF.
Contact Medtronic technical support at +18005959709 for further assistance.
Warning: Electric shock hazard. Always unplug the Generator from the wall outlet prior to cleaning.
The Generator is not sterilizable.
1. Clean the front display, cover, and cord with a mild detergent or mild disinfecting solution
and a damp cloth.
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Maintenance Procedures | Responsibility of the Manufacturer
Whenever possible, use non-flammable agents for cleaning and disinfection. If flammable agents must be
used for cleaning, disinfecting, or as solvents, they should be allowed to evaporate before surgery.
Caution: Do not allow fluids to enter the chassis. Do not use alcohol, caustic, corrosive, or abrasive
materials on the front display, cover, and cord, as they may cause damage to the
equipment. Medtronic recommends following hospital procedures for cleaning the outside
of the Generator after each patient.
For accessory cleaning and maintenance, refer to the user documentation provided with the accessory.
Contact Medtronic technical support at +18005959709 for further assistance.
Responsibility of the Manufacturer
Medtronic is responsible for the safety, reliability, and performance of the AEX™Generator only under the
following circumstances:
• Installation and setup procedures in this planned maintenance guide and the operator manual are
followed.
• Assembly operation, readjustments, modifications, or repairs are carried out by persons
authorized by Medtronic.
• The AEX™ Generator is connected to electrical wiring which complies with local codes and
regulatory requirements.
• The equipment is used in accordance with the AEX™ Generator instructions for use.
For warranty information, refer to the AEX™ Generator Operator Manual.
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2021-04
D00400774
©2021 Medtronic Navigation
All Rights Reserved
UC202117947a EN
Rev A
Medtronic Navigation
826 Coal Creek Circle
Louisville, CO 80027, U.S.A.
Phone +17208903160
Technical Support +18005959709
www.manuals.medtronic.com
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Telephone 31 45 566 80 00
Australia
Medtronic Australasia Pty Ltd.
97 Waterloo Road
North Ryde, NSW 2113
Australia
Printed in the USA
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