Operators Manual
70 Pages
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AEX™ Generator Operator’s Manual 40-405-1
AEX™ Generator Operator’s Manual 40-405-1
Copyright and Trademarks
© 2016, 2017 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. No part of this publication may be reproduced, transmitted, transcribed, stored in retrieval systems, or translated into any form, or by any means: electronic, mechanical, magnetic, optical, or otherwise, without the prior written permission of Medtronic Advanced Energy, LLC, 180 International Drive, Portsmouth, NH 03801, United States of America.
Disclaimer
Medtronic reserves the right to change its products and services at any time to incorporate the latest technological developments. This guide is subject to change without notice.
Only ◆ CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Customer Service Telephone Numbers: U.S. : Tel: Fax:
+1 866 777 9400 +1 866 222 0900
China: Tel: Fax:
+86 21 50800998 +86 21 50800978/50801850
United Kingdom: Tel: +44 1923 212213 Fax: +44 1923 241004
Germany: Tel: +49 211 529 3209 Fax: +49 211 529 3302
France: Tel: Fax:
+33 4 7067 9800 +33 4 7067 9820
India: Tel: Fax:
+91 22 26836733 +91 22 26830806
Belgium-Luxemburg: Tel: +32 2 456 0900 Fax: +32 2 460 2667
Japan: Tel: Fax:
+81 3 6430.2011 +81 3 6430 7110
Canada: Tel: +1 800 268 5346 Fax: +1 905 826 6620
Netherlands: Tel: +31 45 566 8000 Fax: +31 45 566 8042
Contents 1. Preface About This Manual... 1-1 Conventions Used in This Manual... 1-1 Help... 1-1 Indications... 1-1 Contraindications... 1-2 Warnings and Cautions... 1-2 2. Introduction AEX™ Generator... 2-1 Electrosurgical Modes... 2-2 Controls, Displays, and Receptacles... 2-3 3. Installation Initial Inspection... 3-1 Installation... 3-1 Optional Wireless Footswitch... 3-2 Preliminary Checks... 3-2 Preliminary Functional Testing... 3-2 4. Operation... 4-1 Using the Touch Screen... 4-1 Turn on Generator... 4-2 Connect the Patient Return Electrode to Patient and Generator... 4-3 Plugging in the Handpiece to the AEX™ Generator ... 4-4 Loading the Pump Segment Portion of the Handpiece into the Pump Head of the AEX™ Generator... 4-5 Adjusting RF Power Levels... 4-8 Adjusting the Saline Flow Rate... 4-9 Activating the Handpiece... 4-9 Using an Optional Footswitch... 4-9 Adjusting RF Power Settings Using Memory Buttons...4-10 Adjusting the Volume of the Activation Tone...4-10 After Surgery...4-11 Disposing of the Handpiece ...4-11 Preparing the AEX™ Generator for Reuse ...4-11 Transportation and Storage of the AEX™ Generator ...4-12 5. Cleaning and Maintenance Inspections Required Before Each Use... 5-1 Required Annual Inspections... 5-1 Cleaning... 5-1 Maintenance... 5-2 Service... 5-2 Storage... 5-2 Environmental Protection... 5-2 6. Troubleshooting Monopolar and Bipolar Errors... 6-1 Error Code Details... 6-2 Monopolar and Bipolar Faults... 6-5
AEX™ Generator Operator’s Manual
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Fault Code Details... 6-6 Error Codes and Error Handling... 6-9 Troubleshooting Malfunctions...6-10 7. Specifications AEX™ Generator... 7-1 Output Characteristic Curves... 7-7 8. Limited Express Warranty and Disclaimers... 8-1 Limited Express Warranty... 8-1 9. Product Accessories... 9-1 10. Glossary...10-1 11. Symbols...11-1
List of Tables
ii
Table 6-1
Error Codes... 6-1
Table 6-2
Fault Codes... 6-5
Table 6-3
Troubleshooting...6-10
Table 7-1
Mains Input Characteristics... 7-2
Table 7-2
Output Characteristics... 7-3
Table 7-3
Attached Accessory Cables... 7-4
Table 7-4
Electromagnetic Emissions... 7-4
Table 7-5
Electromagnetic Immunity... 7-5
Table 11-1
Symbols...11-1
1. Preface
About This Manual The AEX™ Generator Operator’s Manual provides detailed information on operating and maintaining the AEX™ Generator. This manual and the equipment described within are for use only by qualified medical personnel possessing training in the surgical procedures to be performed. For information on accessories, refer to the appropriate Instructions For Use. The AEX™ Generator is compatible with all Aquamantys™ and PlasmaBlade™ single use only accessories.
Conventions Used in This Manual ▲ WARNING: A warning indicates a hazardous condition that may result in injury or death, if not corrected or avoided. ◆
CAUTION: Alerts you to the possibility of a problem with the device associated with its use or misuse resulting in equipment damage or failure in a procedure, if not corrected or avoided.
■
IMPORTANT: Highlights important information for a particular section.
●
NOTE: Points out additional information that may be helpful.
Help Read through the section of the guide specific to the procedure you are performing. Refer to the table of contents and index to locate information. A glossary is included to assist you with any unfamiliar terms. 1.
See Troubleshooting on page 6-1 for a list of problems and suggested solutions.
2.
For technical support, contact +1 866 777 9400.
Indications The AEX™ Generator is a radio frequency (RF) electrosurgical generator capable of simultaneously powering specified monopolar and bipolar electrosurgical instruments. It is intended to be used for delivery of RF energy to instruments indicated for cutting and coagulation of soft tissue and for delivery of RF energy concurrent with saline to instruments indicated for hemostatic sealing and coagulation of soft tissue and bone. It is intended for, but not limited to, General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological, Thoracic, and Open abdominal surgery procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
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Contraindications The AEX™ Generator with Aquamantys™, Transcollation™ and PlasmaBlade™ should not be used on small appendages or body parts, as in finger surgery or circumcision.
Warnings and Cautions Electrosurgery has been used safely in many procedures. Physicians should be familiar with the medical literature, complications, and hazards associated with electrosurgery before beginning any electrosurgical procedure. Electrosurgery, if misused, can pose dangers to patients or staff, as well as other equipment. Safe and effective electrosurgery is dependent not only on equipment design, but also on factors under the control of the user, such as surgical training and clinical decision making. The warnings and cautions presented in this manual should be read, understood and followed for safety purposes. ▲ Warnings for Equipment Preparation •
Connect the Generator electrical cord to a properly grounded Hospital Grade receptacle. Do not use extension cords or three-prong to two-prong adapters with the Generator. Improper grounding may result in equipment damage, fire at the receptacle, or injury to the patient or user. NOTE: “Use Hospital Grade receptacle for grounding reliability” statement applies to US/North America power cords only.
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•
To allow for appropriate cooling, the unit should not be installed in a cabinet or similar enclosure. If mounted on a shelf, or near a wall, allow a three-inch clearance around the unit to permit free circulation of air on all sides of the unit. Appropriate cooling is necessary to avoid overheating of the unit.
•
Do not stack equipment on top of the AEX™ Generator or place the generator on top of electrical equipment. This may block access to the unit and not allow for proper ventilation.
•
Provide as much distance as possible between the AEX™ Generator and other electronic equipment (such as monitors). An activated electrosurgical generator may cause interference with them.
•
Prior to use, inspect the AEX™ Generator and its accessories for any obvious defects or improper connections. Do not use the Generator if it appears to be damaged, as product failure or injury may occur.
•
Avoid fluid contact with the accessory cable interfaces to the AEX™ Generator receptacles, because shorting can occur which can damage the accessory connectors and/or the AEX™ Generator receptacles.
•
Use only AEX™ Compatible Footswitches.
•
Do not use cords as handles as insulation damage could occur and increase the risk of burns or cause other injury.
•
Do not wrap power cords around metal objects. This may induce currents that could lead to shock, fire, or injury to the patient or surgical team. All power cords should be positioned in a way to avoid contact with the patient or other cables.
•
Nonfunction of the AEX™ Generator may cause interruption of surgery. A backup generator or alternative surgical techniques should always be available.
•
Interference from high frequency surgical equipment may adversely affect the operation of other electronic medical equipment in the operating room. Interference may be resolved or reduced by rearranging the Generator’s cables such that they do not overlap the cables from other equipment, or by using different power outlets or extension cords for the different pieces of equipment.
•
Patient monitoring systems that incorporate high-frequency current-limiting devices are recommended for use in an electrosurgical site.
Preface
▲ Warnings for Accessories •
Prior to use, inspect all accessory devices, handpieces, and the AEX™ Generator for defects. Do not use if insulation or connectors are damaged, because product failure or injury may occur.
•
The AEX™ Generator is compatible with all Aquamantys™ and PlasmaBlade™ handpieces.
•
The AEX™ Generator is not compatible with Aquamantys™3 handpieces.
•
Do not reuse, resterilize or reprocess “Single Use Only” labeled accessory devices, because product failure or injury may occur.
•
The handpieces and Patient Return Electrodes have appropriate connectors and receptacles. Do not attempt to connect to the improper receptacle because connector damage can occur, which may result in a failure. Ensure all connections are secure before activating the system.
•
Verify that the Patient Return Electrode is properly applied to the patient and the cable is securely connected to the Patient Return Electrode receptacle. If there is an improper connection the AEX™ Generator may not operate as intended.
•
Do not connect wet connectors to the AEX™ Generator as this may result in equipment damage, fire at the receptacle, or injury to the patient or user.
•
Do not wrap cords around metal objects as this may induce currents that could produce system performance changes, shocks, fires, or injury to the patient or surgical personnel.
•
Do not use accessories other than the ones recommended in Product Accessories. Use of other accessories may result in an unintended output and/or injury to patient.
•
Use active accessories with rated voltage equal to or greater than that of the AEX™ Generator’s maximum output voltage. ▲ Warnings for Patient Preparation
•
Observe fire precautions at all times. An electrosurgical device may provide an ignition source due to sparking and heating.
•
Do not use in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide and oxygen. Do not activate the unit until vapors from alcohol-based skin prepping agents have dissipated. Naturally occurring gases that accumulate in body cavities can also be an ignition source.
•
Ensure that all oxygen circuit connections and endotracheal tubes are leak-free before and during electrosurgery use. An oxygen leak could result in an airway fire.
•
Inadvertent patient contact may result in burns. When not in use, place all accessory devices in a dry and nonconductive area away from the patient.
•
Position the cables for a Monopolar handpiece and the Patient Return Electrode to avoid patient contact to protect against high frequency current paths to the patient, as such contact may result in patient or user injury.
•
Do not allow patient contact with grounded metal objects or objects that have an appreciable capacitance to earth (e.g., operating table supports), as such contact may result in patient or user injury.
•
Skin-to-skin contact (e.g., between the arms and body of the patient) should be avoided, e.g., by insertion of dry gauze.
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•
Monopolar devices require a Patient Return Electrode. The Generator must detect proper Patient Return Electrode impedance before output can be active. The impedance is continuously monitored and displayed while in Monopolar Mode. The Generator presents audible and visible alarms if it detects improper impedance with the Patient Return Electrode in Monopolar Mode and will disable Generator output. Unless a compatible split foil Patient Return Electrode is used, loss of safe contact between the return electrode and the patient will not result in an audible and visible alarm, and the Generator output will not be disabled. The entire area of the Patient Return Electrode should be reliably attached to a suitably prepared and appropriate area of the patient’s body as defined by the manufacturer. Refer to the manufacturer’s instructions for application site and placement procedures when applying the Patient Return Electrode. Do not rely entirely on the impedance sensing feature. It can be affected by a damaged (shorted) Patient Return Electrode. It is recommended that the operator verify appropriate placement and contact of the Patient Return Electrode. Inadequate contact of the Patient Return Electrode may result in patient alternate site burns or injury.
•
Do not cut a Patient Return Electrode to reduce size as this could result in high current density patient burns.
•
Heat applied by thermal blankets or other sources may be cumulative with heat from the Patient Return Electrode (caused by electrosurgical currents). Choose a Patient Return Electrode site remote from other heat sources to help minimize the risk of patient injury.
•
Electrodes and probes used with monitoring, stimulating, and imaging devices can provide paths for high frequency currents even if the electrodes or probes are insulated, battery operated, and/or isolated at 50/60 Hz. To reduce the risk of burns, place any such electrode or probe as far away as possible from the electrosurgical site and the Patient Return Electrode.
•
Needle monitoring electrodes are not recommended as burns may inadvertently result.
•
The active device should not be used near electrocardiograph electrodes as it may cause interference.
•
Physiological monitoring devices and their monitoring electrodes should be positioned away from the surgical site where the AEX™ System will be utilized.
•
Always use the lowest RF power setting to achieve the desired surgical effect. Pediatric applications and/ or procedures performed on small anatomic structures may require reduced power settings. The higher the power and the longer the power is applied, the greater the possibility of unintended thermal damage to tissue.
•
Adequate ventilation to reduce electrosurgical smoke by use of a smoke-plume evacuator or other means is recommended.
•
Do not attempt to alter device configurations or replace device components with nonstandard parts since this may result in decreased device performance, device malfunction, or patient injury.
•
Transcollation delivers RF energy in conjunction with saline. Do not inhibit the delivery of saline as burns may inadvertently result. ▲ Warnings for Active Implants
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•
If the patient has an internal cardiac defibrillator (ICD), contact the ICD manufacturer for instructions before performing an electrosurgical procedure. Electrosurgery may cause multiple activations of ICDs.
•
Use the AEX™ System with caution in the presence of pacemakers or other active implants, as electrosurgical equipment may cause interference with these devices or cause them to malfunction. Consult the active implant manufacturer for further information before proceeding with the surgery.
•
The use of electrosurgery in the presence of internal or external active implants is potentially hazardous.
•
To minimize the possibility of active implant interference, place the Patient Return Electrode such that the electrosurgical current path is as far as possible from the active implant lead.
•
Direct contact with implanted leads can cause physical damage to the leads. Exercise caution around leads associated with any active implant; particularly those with thin insulation. Preface
▲ Warnings for Use •
It is recommended that physicians utilize pre-clinical training, review of pertinent literature, and other appropriate educational tools before attempting newer surgical procedures, such as endoscopic, laparoscopic, or thoracoscopic procedures.
•
Read the warnings, precautions, and instructions provided with AEX™ disposable handpieces before using. Specific instructions are not included in this manual.
•
If using the optional footswitch, ensure that the footswitch is not inadvertently depressed to prevent the device from being unintentionally activated. Place the footswitch in a location necessitating deliberate action in order to activate the unit.
•
If using the optional footswitch, only the primary surgeon using the handpiece should operate the footswitch. Unintentional activation may occur if the footswitch is activated by a separate user, which may result in patient or user injury.
•
Ensure that the sound volume on the Generator is adequately adjusted so that the activation tones are clearly heard. The activation tones are intended to alert the user that the device is active. This will help prevent unintended contact with the device which could result in patient or user injury.
•
Examine the handpiece before connecting it to the AEX™ Generator. After connecting the handpiece, ensure that the handpiece and the unit are functioning as intended.
•
Consult the operating and user manuals for light sources and other ancillary devices for warnings, precautions, and instructions prior to their use with the AEX™ Generator.
•
Position the AEX™ Generator away from life supporting and/or monitoring systems to reduce/avoid interference with these systems.
•
The interference produced by the operation of RF surgical equipment may adversely influence the operation of other electronic equipment.
•
DO NOT use electrosurgery in the presence of flammable anesthetics or other flammable gases, near flammable fluids or objects, or in the presence of oxidizing agents as fire could result.
•
The cable on the disposable handpieces should be positioned in a way to avoid contact with the patient or other cables.
•
Monitoring systems incorporating RF current limiting devices are recommended.
•
For surgical procedures where the RF current could flow through parts of the body having a relatively small cross sectional area, the use of bipolar techniques may be desirable in order to avoid unwanted tissue damage.
•
During use, a diminished power output may indicate that the Patient Return Electrode connection has been compromised, failure of an electrical lead, active electrode insulation failure or excessive eschar buildup on the active electrode tip. Do not increase the power output before checking for obvious defects or improper connections. Check for effective contact of the Patient Return Electrode to the patient any time that the patient is moved after initial application of the Patient Return Electrode.
•
If the system resets due to a power interruption or low voltage, the system will check for effective contact of the Patient Return Electrode, however the user should verify effective contact of the Patient Return Electrode visually prior to resuming electrosurgery.
•
If power levels were increased to compensate diminished performance, it is recommended to reduce power to the original or a lower level upon resumption of use.
•
The output power selected should be as low as possible for the intended purpose.
•
Failure of the high-frequency surgical equipment could result in an unintended increase of output power.
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•
Do not use Monopolar electrosurgery on small appendages, such as in finger surgery, as it can cause thrombosis or other unintended injury to tissue proximal to the surgical site.
•
Studies have shown that smoke generated during electrosurgery may be harmful to surgical personnel. These studies recommend the use of a surgical mask and adequate ventilation of the smoke using a surgical smoke evacuator or other means.
•
Neuromuscular stimulation can occur causing unexpected patient movement, especially with modes producing electrical arcs between the active device electrode and tissue. Use caution in proximity to neural structures.
•
Observe all caution and warning notices printed on the unit.
•
Operating room staff should never contact the handpiece tip while the Generator is active, as injury may result.
•
The tip of a recently activated handpiece may be hot enough to cause patient burns or ignite surgical drapes or other flammable material. When not in use, store the device in an electrically insulated container or holster. Never place or rest a handpiece on the patient. ▲ Warnings for Testing or Servicing
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•
Do not remove the Generator cover due to electrical shock hazard. There are no user serviceable parts inside.
•
Never remove or install any parts with power ON, as this may result in potential for electrical shock or injury. Use only Medtronic Advanced Energy approved replacement parts in order to avoid potential equipment damage or injury.
•
Avoid contact with the output leads when the Generator is activated as this may result in injury. Periodically inspect the test leads used for the output connections for obvious defects.
•
The Generator is not designed to operate for extended periods of continuous output. When testing, it is recommended that duty cycles be limited to 25% with maximum activation times of 10 seconds into a load greater than or equal to 600 ohms. Use for an extended period of time may result in overheating and equipment damage.
•
Periodic maintenance should be performed by a hospital qualified biomedical technician or by a qualified Medtronic representative.
•
Minimizing operating temperature and extreme thermal cycles will extend the equipment life.
•
The heat dissipation capability of the Generator heat sink may be severely impaired by activating the AEX™ Generator in other than a normal operating position. Testing or using the unit in any other position should be avoided.
Preface
2. Introduction
AEX™ Generator The AEX™ Generator is one component of the AEX™ Surgery System. The Generator provides radio frequency (RF) energy to disposable Monopolar and Bipolar electrosurgical handpieces. The AEX™ Generator accepts a Patient Return Electrode for monopolar applications, and includes a rotary peristaltic pump for simultaneous delivery of saline for a hemostatic sealing. Figure 2-1. AEX™ Generator and AEX™ Wireless Footswitch
AEX™ Generator
AEX™ Wireless Footswitch
RF Power The AEX™ Generator delivers Bipolar RF power and saline with power settings in 5 watt increments in the range of 20 to 100 Watts and 10 Watt increments in the range of 100 to 220 Watts. The AEX™ Generator delivers Monopolar Cut, Coag, and Transcollation RF energy with a power output capable of up to 90 Watts. All PlasmaBlade™ handpieces powered by the PlasmaBlade™ port contain an embedded chip dictating the settings for that particular handpiece. Aquamantys™ handpieces do not have embedded chips. These settings are described in the Instructions For Use accompanying the handpiece.
Simultaneous RF Power and Saline Delivery The AEX™ Generator simultaneously delivers RF power and saline to Bipolar Handpieces and certain Monopolar Handpieces when they are properly connected to the unit and the activation button on the handpiece is depressed. For a list of all compatible simultaneous handpieces, please contact Medtronic Advanced Energy Customer Service at +1 866 777 9400.
Saline Flow Rate Setting The saline flow rate setting is determined based on the power setting and the selection of one of three possible flow rate settings: Low, Medium, and High. The three possible saline flow rates for each power setting are preset automatically in order to provide the optimal saline flow for a given power setting.
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Priming The AEX™ Generator has a convenient one touch priming function which automatically primes the Transcollation handpiece with saline prior to use after the device has been correctly connected to the unit. This function is activated by pressing the “PRIME” button on the unit.
Electrosurgical Modes The AEX™ Generator operates in the following modes:
Cut Modes (Monopolar) •
Low Cut (Peak Cut) – Precision cutting with minimal hemostasis and minimal collateral damage
•
Medium Cut (Pure Cut) – Precision cutting with increased hemostasis and collateral damage
•
High Cut (Blend Mode) – Precision cutting with strong hemostasis
Coagulation Modes (Monopolar) •
Coagulation increases with higher settings.
•
Low Coag (Pinpoint)
•
High Coag (Spray)
Hemostatic Sealing Modes (Monopolar or Bipolar) •
Simultaneous delivery of RF energy with saline for hemostatic sealing of soft tissue and bone.
■
IMPORTANT:
•
Each cut, coagulation, and seal mode has multiple power settings available.
•
Handpiece models vary and may not utilize all modes. Available modes for each handpiece are per applicable handpiece Instructions For Use.
Other features of the AEX™ Generator include:
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•
Proprietary handpieces developed by Medtronic Advanced Energy to deliver RF energy to the patient. Only Medtronic Advanced Energy handpieces may be used with the AEX™ Generator.
•
Handpiece control
•
Handpiece with footswitch control
•
Simultaneous activation of 2 handpieces
•
Device default settings recognition
•
Monopolar and Bipolar outputs
•
Connection to Patient Return Electrode
•
Color LCD to prompt user for input and to display informational, error, and fault messages
•
Audio feedback of activation and alarm tones
Introduction
Controls, Displays, and Receptacles This section describes each component of the AEX™ Generator and its function. The controls, displays, and receptacles for Monopolar and Bipolar handpieces, Patient Return Electrodes, and the footswitch are located on the front and rear panels of the Generator. ▲ WARNING: Read all warnings and instructions provided with the Generator prior to use. Front Panel Layout Description Refer to Figure 2-2 for a complete front panel illustration. Each display, control, or receptacle is described in more detail below. Figure 2-2. Front Panel Layout
6. Touch Screen Display
1. Power Switch
2. PlasmaBlade™ and Combo Receptacle
3. Patient Return Electrode Receptacle with Illumination of Connection Status
4. Aquamantys™ Receptacle
5. Rotary Peristaltic Pump
1. Power Switch – A black rocker switch that toggles right to turn the AEX™ Generator power on and toggles left to turn the power off.
2. PlasmaBlade™ and Combo Receptacle – A seven-pin circular receptacle that accepts PlasmaBlade™ and Combo handpieces.
3. Patient Return Electrode Receptacle – A standard two-pin receptacle that accepts the Patient Return Electrode connector used in Monopolar procedures.
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4. Aquamantys™ Receptacle – A three-pin rectangular receptacle that accepts Aquamantys™ handpieces. 5. Saline Pump – This is a rotary peristaltic pump. A special pump segment is attached to the saline delivery tubing of each disposable handpiece which is designed to operate with the pump. The pump segment is loaded into this pump head prior to operation of the device. 6. Touch Screen Display – Screen used to prompt the user for input and to display informational and fault messages to user. Panel Layout Description Refer to Figure 2-3 for a complete back panel illustration. Each control, receptacle, or panel is described in more detail below. Figure 2-3. Back Panel Layout
1. RS-232 Port
2. USB Port
3. Footswitch Connector 4. Fuse Drawer 5. AC Mains Input 6. Equipotential Ground Connector
7. Name Plate
1. RS-232 Port – Service port for use by trained personnel only.
2. USB Port – Enables uploading of software and downloading of usage data.
3. Footswitch Connector – A connector that accepts an AEX™ Wireless Footswitch connector. 4. Fuse Drawer – This fuse drawer contains two fuses.
2-4
Introduction
5. Power Entry / AC Mains – The power entry module combines the connector for the 3-prong, Hospital-Grade power cord with removable enclosure holding two line fuses. Always use fuses of the rating shown in “Mains Input Characteristics” on page 7-2 of this manual. ● NOTE: “Use Hospital Grade receptacle for grounding reliability” statement applies to US/North America power cords only. 6. Equipotential Ground Connector – Standard connector for connecting common grounds. 7. Name Plate – This plate specifies the model number, serial number, nominal line voltages, frequency, current, and fuse rating information for the AEX™ Generator.
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2-6
Introduction
3. Installation
Initial Inspection Unpack the Generator upon receipt and physically inspect it for any obvious damage that may have occurred during shipment. A qualified biomedical engineer or personnel familiar with electrosurgical devices should perform this inspection. If the Generator is damaged, call +1 866 777 9400 for assistance.
Installation The AEX™ Generator should be placed on a flat and stable surface. ▲ WARNING: The Hospital Grade power cord of the Generator should be connected to a properly polarized and grounded power source whose voltage and frequency characteristics are compatible with those listed on the nameplate of the AEX™ Generator (located on the rear panel of the Generator). Improper grounding may result in equipment damage, fire at the receptacle, or injury to the patient or user. To completely disconnect the Generator from the AC mains, the power cord needs to be unplugged from the power source. Do not position generator such that removal of the power cord from the power source would be difficult. ●
NOTE: “Use Hospital Grade receptacle for grounding reliability” statement applies to US/North America power cords only.
▲ WARNING: To allow for appropriate cooling, do not install the Generator in a cabinet or similar enclosure. If mounted on a shelf or near a wall, allow a 3-inch clearance around the Generator to permit free air circulation on all sides. Appropriate cooling is necessary to avoid overheating of the Generator.
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Optional Wireless Footswitch ●
NOTE: The optional wireless footswitch is only compatible with enabled monopolar handpieces. Monopolar activation may be initiated either from a footswitch or a handpiece. Transcollation function cannot be activated by the footswitch.
1.
If using the optional footswitch, plug the wireless receiver into the footswitch connector of the AEX™ Generator (see Figure 2-3 on page 2-4).
2.
Turn on the AEX™ Generator and ensure that the wireless receiver’s power-on LED is green, indicating that the receiver is powered on. Figure 3-1. Wireless Receiver
Power-On LED Indicator
▲ WARNING: Only the primary surgeon using the handpiece should operate the footswitch. Unintentional activation may occur if the footswitch is activated by a separate user, which may result in patient or user injury. Refer to the Wireless Footswitch Operator’s Manual for detailed product information.
Preliminary Checks Prior to installing and using the Generator, it is strongly recommended that a qualified maintenance technician ensure proper and safe operation by testing the performance of the Generator. If anomalous behavior is observed, the Generator should not be used until all issues have been resolved by a qualified technician. Call Medtronic Advanced Energy Customer Service at +1 866 777 9400.
Preliminary Functional Testing Preliminary functional testing should be conducted by a qualified technician or operating room personnel. Personnel conducting functional tests should read this manual prior to testing. 1.
Turn on the Generator by pressing the power switch.
2.
Verify the following occurs: •
3-2
A self-test screen appears indicating that the system is performing a power-on self-test as shown in Figure 3-2. The software version is also shown at the bottom of the screen. If the self-test screen does not appear, cycle the power and try again. If the same problem continues, call Medtronic Advanced Energy Customer Service at +1 866 777 9400. Do not attempt to use the Generator until the problem has been resolved.
Installation
Figure 3-2. Front Panel Showing Self-Test Screen.
•
The Cut and Coag activation tones will sound to allow you to verify operation.
•
The screen in Figure 3-2 will disappear when the self-test is complete. If the self-test is not successful, an alarm tone will sound, a Fault Code will be displayed on the LCD screen and the Generator output will be disabled. The alarm tone will sound until the Generator is turned off. In this case, call Medtronic Advanced Energy Customer Service. Do not attempt to use the Generator until the problem has been resolved.
•
If the self-test is successful, verify the following:
•
If the Generator is powered on with no handpieces connected, the Generator displays the following operational screen. Figure 3-3. Front Panel Showing Operational Screen with No Devices Connected.
Figure 3-4. Front Panel Displaying the Screen with PlasmaBlade™ Handpiece Connected.
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