�.AICRO.AIRE®

For Surgery. For Life.™

Power-Assisted Liposuction

In-Service

PAL® System Care & Maintenance Training Console, Cable, & Handpiece

LIT-PAL-CS Rev. A 1

Power Assisted Liposuction System

• PAL-650 Handpiece

• 5006-PAL Cable

• 5020 Console

LIT-PAL-CS Rev. A 2

PAL® Electric Console

• ALL personnel should become familiar with theequipment prior to use in a procedure.

• Personnel should include, but not be limited to:central processing members of surgical team bioengineering department

• All MicroAire power equipment should beinspected and tested in accordance with thefacility’s bioengineering policy. The bioengineeringdepartment should document the service.

LIT-PAL-CS Rev. A 3

PAL® Electric Console

Color Touch Screen

Power/Stand By Button

USB for MicroAire Service Center Software Upgrades

Blue LED Powered Instrument Confirmation Signal

Two Instrument Connectors

Foot Pedal Connector

Onboard Irrigation Pump

LIT-PAL-CS Rev. A 4

Electric Console

• Dual instruments operation

• Touch screen – pressure sensitive(this is not a smart device and needspressure to activate in an OR glovedenvironment)

• Platform for growth

• Smart Loop Instrument Control

• Plug and Play capable

• Intuitive Graphical User Interface

• Incorporated irrigation and foot control

For more information, please reference PAL Electric Console Instruction for Use (IFU) “IM-5025”

LIT-PAL-CS Rev. A 5

PAL® Handpiece

• The PAL Electric Handpiece is designed to operatefor up to 20 minutes of continuous use withintermittent operation over a period of 2 hours.

• Prolonged usage above and beyond this duty cyclemay result in the device feeling warm to the touch.This indicates that the device needs to cool down.

For more information, please reference PAL System Instructions for Use (IFU) “IM-PAL-650”

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Installation /Set Up

• Before installation of PAL system, ALWAYS read theprovided Instructions for Use (IFU).

• Inspect Handpiece, Console, Cable and Cannulas forcorrosion, damage, excessive wear and residual moisture.

• Ensure the console is placed on a stable flat surfaceprotected from fluid exposure and accidental damage.

• Attach the electrical connection cable from the back ofthe Console (REF 5020) to a wall outlet, and allow theconsole to boot up.

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• Align indexing dots of cable with those on Handpiece and Console before connecting cable into device or Console.

• DO NOT twist the cables into position; this will damage the connections and may prevent cable from attaching todevice or console.

Cable Insertion

LIT-PAL-CS Rev. A 8

Damaged Connector Contacts

• Indicates misalignment and/or twisting of cable when inserted or removed from the PAL Handpiece orConsole.

• Any indication of damaged or bent pins should prompt return of product for evaluation by MicroAire.

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Cleaning & Sterilization

PAL-650, 5020, 5006-PAL

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Cleaning & Sterilization Chart

• Your PAL device comes with a laminated cleaning &sterilization chart to facilitate good practices.

• Always make sure the cleaning & sterilizationinstructions are posted and are followed.

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Instruments must be cleaned within 30 minutes of end use to minimize organic material drying.

• Only pH neutral cleaning agents are acceptablefor cleaning your PAL Handpiece and cables. HighpH cleaners will damage the finish, encouragecorrosion, and result in more frequent equipmentmaintenance.

• DO NOT utilize cleaning agents with chlorine orchloride as the active ingredient is corrosive tostainless steel.

• DO NOT lubricate or oil the PAL Handpiece.Lubrication may damage the internal motormechanism. Also take special precautions to avoidthe use of cleaners that contain lubricants.

Cleaning

For more information, please reference PAL System Instruction for Use (IFU) “IM-PAL-650” and “IM-5025”

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PAL® Handpiece Cleaning

ALWAYS connect CAP-600E or PAL Cable to PAL Handpiece prior to commencement of manual cleaning. ONLY CAP-600E is sufficient to prevent water intrusion with an automated washing system.

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PAL® Cable Cleaning

ALWAYS install washer caps on 5006-PAL cable prior to cleaning to ensure electrical contacts are protected.

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Manual Cleaning/Processing

• Refer to the PAL-650 Instructions for Use (IFU) forcleaning parameters, as any deviation from theseparameters may result in inadequate cleaning ofPAL Handpiece and cable.

• Clean the Handpiece thoroughly with warm(> 60 °C / 140 °F) water, pH neutral enzymaticdetergent, and a soft brush. Scrub the Handpiecewith a brush, paying close attention toinstrument crevices.

• Rinse thoroughly under running (< 50 °C / 122 °F)water for a minimum of 2 minutes. If possible,use distilled water for the final rinse.

For more information, please reference PAL System Instructions for Use (IFU) “IM-PAL-650” and “IM-5025”

LIT-PAL-CS Rev. A 15

Cap it!

• Main cause of PAL repairs is improper cleaning andsterilization.

• Liquid causes corrosion.

• The cable can be used as a plugwhen cleaning (manual cleaning only).

• Or use the CAP-600E for manual or automatic cleaning.

“Clean CLOSED” “Steam OPEN” Prevent liquid water from entering the body of the instrument

Ensure that steam can sterilize inside

ALWAYS RUN A COMPLETE DRY CYCLE

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Preparing for Sterilization

• Prior to sterilization, wipe off any water fromHandpiece with a soft lint-free towel.

• The washer cap or electric cable from theHandpiece and the washer caps from your PALcable MUST BE REMOVED prior to sterilization.

• Caps or cable connected to a device duringsterilization will impede the drying process andresult in residual moisture being left inside ofdevice or cable.

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Technique for Removal of Cap off of Cable

The collar must be pulled back on the cable to release the locking tabs prior to the release of cap.

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Packaging

• Verify that the sterilization pouch is breathableenough to ensure moisture is completely removedduring the dry cycle and the wrap is large enoughto contain the instrument without stressing thepackage.

• Single Instruments - A standard medical gradesteam sterilization wrap may be used.(ASTM/AAMI ST79, EN ISO 17665-1)

• Sets of Instruments - May be loaded intodedicated instrument trays or general purposesterilization trays for sterilization. If applicable,use standard medical grade steam sterilizationwrap following the AAMI double wrap method(ANSI/AAMI ST79, EN ISO 17665-1).

For more information, please reference PAL System Instructions for Use (IFU) “IM-PAL-650” and “IM-5025”

LIT-PAL-CS Rev. A 19

• All sterilization cycles require a MINIMUMDRY CYCLE exposure time of 20 MINUTES.

• This is a minimum requirement and shouldbe increased accordingly until ALL evidenceof moisture have been removed from thedevice and packaging.

• Never shorten the dry cycle, this may resultin service interruptions related to residualmoisture and corrosion that may not bevisible during examination.

• Always allow the PAL Handpiece and Cableto cool slowly at room temperature.Attempting use prior to cooling may result inlost functionality and/or damage the system.

IFU Steam Sterilization

For more information, please reference PAL Cleaning & Sterilization Chart (IM-PAL-CS)

LIT-PAL-CS Rev. A 20

Inadequate Dry Cycle

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Damaged Contacts from Residual Moisture

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The Internal Effects of Improper Cleaning / Drying

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• Moisture induced issues are typically intermittent and can occur at any time the system is in use.

• Moisture and corrosion issues that result from inadequate cleaning/reprocessing areNOT COVERED UNDER WARRANTY, resulting in significantly higher repair charges.

• Moisture and corrosion issues WILL REOCCUR unless staff responsible for cleaning/reprocessing areinformed.

The Impact of Improper Cleaning / Drying

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Encountering Diagnostic Codes

PAL-650, 5020, 5006-PAL

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The 5020 Console is equipped with diagnostic functions to address any errors/anomalies detected with PAL system.

Diagnostic Codes

Each diagnostic code is assigned a number.

Provides explanation of code.

For more information, please reference PAL Electric Console Instructions for Use (IFU) “IM-5025”

LIT-PAL-CS Rev. A 26

• In this case, the error code number is 16, and the description is “Instrument Hall Failure Alert”.

• Many codes provide instructions on what is required to clear the codes; however, most indicate an issue withthe system that must be addressed via swapping out that piece of equipment.

Diagnostic Codes

For more information, please reference PAL Electric Console Instructions for Use (IFU) “IM-5025”

LIT-PAL-CS Rev. A 27

• With the exception of Temperature, Communication, Stall, or Electromagnetic Interference codes, most ofthe remaining codes can be an indication of a bad connection.

• To verify a proper connection, remove the cable from the Handpiece, and from the Console and inspect thecontacts for the following conditions:

• Moisture

• Signs of Corrosion

• Indications of Damaged or Bent Pins

• Corrosion can impede the electrical signals of your PAL system and may or may not be corrected bydetaching/reattaching the cable. Any visible signs of corrosion should prompt return of the product forevaluation by MicroAire.

• Any indication of damaged or bent pins should prompt return of the product for evaluation by MicroAire.

Diagnostic Codes

For more information, please reference PAL Electric Console Instructions for Use (IFU) “IM-5025”

LIT-PAL-CS Rev. A 28

Alert Icons and Definitions

For more information, please reference PAL Electric Console Instructions for Use (IFU) “IM-5025”

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Example of Good Contacts

Contacts are clean, reflective, and gold in color.

LIT-PAL-CS Rev. A 30

Corrosion in Contacts

Contacts are dirty, non-reflective, and green/black in color.

LIT-PAL-CS Rev. A 31

Preventative Maintenance & Repair Service

PAL-650, 5020, 5006-PAL

LIT-PAL-CS Rev. A 32

• MicroAire Customer Number.

• A clear description of why you wish toreturn your product; PreventativeMaintenance or Repair.

• The part number and serial number ofyour Console, Cable and PALHandpiece that was in use at the timeof the encountered issue and thediagnostic code.

• Specific details of the encounteredissue and attempts of trouble shootingto resolve the matter.

• To avoid delays and to ensure thatyour service needs are met MicroAirewants the best point of contactregarding the reported issue.

Required Information for Service Needs

LIT-PAL-CS Rev. A 33

• MicroAire recommends the PAL System(PAL-650 Handpiece, 5006-PAL Cable and5020 Console) be returned to the factoryfor routine inspection and service at leastonce a year.

• There is no charge for service during thewarranty period.

• 1 year preventative maintenance service isrecommended for devices that arereprocessed 1-2 times per day.

• More frequent PM service may be requireddepending upon the usage of your PALHandpiece & Cable.

Preventative Maintenance

For more information, please reference PAL System Instructions for Use (IFU) “IM-PAL-650” and “IM-5025”

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Part and Serial Number Information on the Handpiece

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Part and Serial Number Information on the Console

LIT-PAL-CS Rev. A 36

Part and Serial Number Information on the Cable

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• After providing the required information you will be issued an Return Material Authorization (RMA) number.The RMA number will identify your service request and the repair status.

• Note the RMA number on the package or packing slip when returning your equipment for evaluation.

For service contact our Customer Service Department at:

MicroAire Surgical Instruments LLC

3590 Grand Forks Boulevard

Charlottesville, VA 22911 USA

Telephone: FAX: Email:

USA: 800-722-0822 800-438-6309 inquiry@microaire.com

OUTSIDE USA: +434-975-8000 +434-975-4134 inquiry@microaire.com

Key Information for Service Needs

LIT-PAL-CS Rev. A 38

MicroAire Customer Service For any questions concerning the information in this presentation, please

contact our customer service department:

Telephone / FAX

USA: 800-722-0822 / 800-438-6309

OUTSIDE USA: +434-975-8000 / +434-975-4134

Email: inquiry@microaire.com

MicroAire Surgical Instruments, LLC 3590 Grand Forks Boulevard Charlottesville, VA 22911 · USA © 2016 All rights reserved.

Phone: 800 722 0822 or +434 975 8000 Fax: 800 648 4309 or +434 975 4131 www.microaire.com

LIT-PAL-CS Rev. A 39