MicroAire PAL User Manual

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Power-Assisted Liposuction
In-Service
®
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PAL® System Care & Maintenance Training
Console, Cable, & Handpiece
LIT-PAL-CS Rev. A 1
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PAL-650 Handpiece
5006-PAL Cable
5020 Console
LIT-PAL-CS Rev. A 2
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PAL® Electric Console
ALL personnel should become familiar with the
equipment 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 be
inspected and tested in accordance with the
facility’s bioengineering policy. The bioengineering
department should document the service.
LIT-PAL-CS Rev. A 3
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Power/Stand By Button
USB for MicroAire Service Center Software Upgrades
PAL® Electric Console
Color Touch Screen
Onboard Irrigation Pump
Foot Pedal Connector
Two Instrument Connectors
Blue LED Powered Instrument Confirmation Signal
LIT-PAL-CS Rev. A 4
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Dual instruments operation
Touch screen – pressure sensitive
(this is not a smart device and needs pressure to activate in an OR gloved environment)
Platform for growth
Smart Loop Instrument Control
Plug and Play capable
Intuitive Graphical User Interface
Incorporated irrigation and foot control
Electric Console
For more information, please reference PAL Electric Console Instruction for Use (IFU) “IM-5025”
LIT-PAL-CS Rev. A 5
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PAL® Handpiece
The PAL Electric Handpiece is designed to operate
for up to 20 minutes of continuous use with intermittent operation over a period of 2 hours.
Prolonged usage above and beyond this duty cycle
may 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”
LIT-PAL-CS Rev. A 6
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Installation /Set Up
Before installation of PAL system, ALWAYS read the
provided Instructions for Use (IFU).
Inspect Handpiece, Console, Cable and Cannulas for corrosion, damage, excessive wear and residual moisture.
Ensure the console is placed on a stable flat surface protected from fluid exposure and accidental damage.
Attach the electrical connection cable from the back of the Console (REF 5020) to a wall outlet, and allow the console to boot up.
LIT-PAL-CS Rev. A 7
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Cable Insertion
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 to
device or console.
LIT-PAL-CS Rev. A 8
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Damaged Connector Contacts
Indicates misalignment and/or twisting of cable when inserted or removed from the PAL Handpiece or Console.
Any indication of damaged or bent pins should prompt return of product for evaluation by MicroAire.
LIT-PAL-CS Rev. A 9
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LIT-PAL-CS Rev. A 10
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 & sterilization instructions are posted and are followed.
LIT-PAL-CS Rev. A 11
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Cleaning
Instruments must be cleaned within 30 minutes of end use to minimize organic material drying.
Only pH neutral cleaning agents are acceptable
for cleaning your PAL Handpiece and cables. High
pH cleaners will damage the finish, encourage corrosion, and result in more frequent equipment maintenance.
DO NOT utilize cleaning agents with chlorine or
chloride as the active ingredient is corrosive to stainless steel.
DO NOT lubricate or oil the PAL Handpiece.
Lubrication may damage the internal motor
mechanism. Also take special precautions to avoid
the use of cleaners that contain lubricants.
For more information, please reference PAL System Instruction for Use (IFU) “IM-PAL-650” and “IM-5025”
LIT-PAL-CS Rev. A 12
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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.
LIT-PAL-CS Rev. A 13
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PAL® Cable Cleaning
ALWAYS install washer caps on 5006-PAL cable prior to cleaning to ensure electrical contacts are protected.
LIT-PAL-CS Rev. A 14
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Manual Cleaning/Processing
Refer to the PAL-650 Instructions for Use (IFU) for
cleaning parameters, as any deviation from these parameters may result in inadequate cleaning of PAL Handpiece and cable.
Clean the Handpiece thoroughly with warm
(> 60 °C / 140 °F) water, pH neutral enzymatic
detergent, and a soft brush. Scrub the Handpiece with a brush, paying close attention to instrument 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
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Cap it!
Main cause of PAL repairs is improper cleaning and sterilization.
Liquid causes corrosion.
The cable can be used as a plug
when cleaning (manual cleaning only).
Or use the CAP-600E for manual or automatic cleaning.
“Clean CLOSED”
Prevent liquid water from entering the body
of the instrument
ALWAYS RUN A COMPLETE DRY CYCLE
LIT-PAL-CS Rev. A 16
“Steam OPEN”
Ensure that steam
can sterilize inside
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Preparing for Sterilization
Prior to sterilization, wipe off any water from Handpiece with a soft lint-free towel.
The washer cap or electric cable from the Handpiece and the washer caps from your PAL cable MUST BE REMOVED prior to sterilization.
Caps or cable connected to a device during sterilization will impede the drying process and result in residual moisture being left inside of
device or cable.
LIT-PAL-CS Rev. A 17
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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.
LIT-PAL-CS Rev. A 18
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Packaging
Verify that the sterilization pouch is breathable enough to ensure moisture is completely removed during the dry cycle and the wrap is large enough to contain the instrument without stressing the package.
Single Instruments - A standard medical grade
steam sterilization wrap may be used. (ASTM/AAMI ST79, EN ISO 17665-1)
Sets of Instruments - May be loaded into
dedicated instrument trays or general purpose sterilization trays for sterilization. If applicable, use standard medical grade steam sterilization wrap 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
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IFU Steam Sterilization
All sterilization cycles require a MINIMUM
DRY CYCLE exposure time of 20 MINUTES.
This is a minimum requirement and should
be increased accordingly until ALL evidence of moisture have been removed from the device and packaging.
Never shorten the dry cycle, this may result
in service interruptions related to residual
moisture and corrosion that may not be
visible during examination.
Always allow the PAL Handpiece and Cable
to cool slowly at room temperature.
Attempting use prior to cooling may result in
lost functionality and/or damage the system.
For more information, please reference PAL Cleaning & Sterilization Chart (IM-PAL-CS)
LIT-PAL-CS Rev. A 20
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Inadequate Dry Cycle
LIT-PAL-CS Rev. A 21
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Damaged Contacts from Residual Moisture
LIT-PAL-CS Rev. A 22
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The Internal Effects of Improper Cleaning / Drying
LIT-PAL-CS Rev. A 23
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The Impact of Improper Cleaning / Drying
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 are
NOT COVERED UNDER WARRANTY, resulting in significantly higher repair charges.
Moisture and corrosion issues WILL REOCCUR unless staff responsible for cleaning/reprocessing are
informed.
LIT-PAL-CS Rev. A 24
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Encountering Diagnostic Codes
LIT-PAL-CS Rev. A 25
PAL-650, 5020, 5006-PAL
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Diagnostic Codes
The 5020 Console is equipped with diagnostic functions to address any errors/anomalies detected with PAL system.
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
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Diagnostic Codes
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 with
the system that must be addressed via swapping out that piece of equipment.
For more information, please reference PAL Electric Console Instructions for Use (IFU) “IM-5025”
LIT-PAL-CS Rev. A 27
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Diagnostic Codes
With the exception of Temperature, Communication, Stall, or Electromagnetic Interference codes, most of
the 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 the
contacts 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 by
detaching/reattaching the cable. Any visible signs of corrosion should prompt return of the product for evaluation by MicroAire.
Any indication of damaged or bent pins should prompt return of the product for evaluation by MicroAire.
For more information, please reference PAL Electric Console Instructions for Use (IFU) “IM-5025”
LIT-PAL-CS Rev. A 28
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Alert Icons and Definitions
For more information, please reference PAL Electric Console Instructions for Use (IFU) “IM-5025”
LIT-PAL-CS Rev. A 29
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Example of Good Contacts
Contacts are clean, reflective, and gold in color.
LIT-PAL-CS Rev. A 30
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Corrosion in Contacts
Contacts are dirty, non-reflective, and green/black in color.
LIT-PAL-CS Rev. A 31
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Preventative Maintenance & Repair Service
LIT-PAL-CS Rev. A 32
PAL-650, 5020, 5006-PAL
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Required Information for Service Needs
MicroAire Customer Number.
A clear description of why you wish to
return your product; Preventative Maintenance or Repair.
The part number and serial number of
your Console, Cable and PAL Handpiece that was in use at the time of the encountered issue and the diagnostic code.
Specific details of the encountered
issue and attempts of trouble shooting to resolve the matter.
To avoid delays and to ensure that
your service needs are met MicroAire wants the best point of contact regarding the reported issue.
LIT-PAL-CS Rev. A 33
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Preventative Maintenance
MicroAire recommends the PAL System (PAL-650 Handpiece, 5006-PAL Cable and 5020 Console) be returned to the factory
for routine inspection and service at least
once a year.
There is no charge for service during the warranty period.
1 year preventative maintenance service is recommended for devices that are reprocessed 1-2 times per day.
More frequent PM service may be required depending upon the usage of your PAL Handpiece & Cable.
For more information, please reference PAL System Instructions for Use (IFU) “IM-PAL-650” and “IM-5025”
LIT-PAL-CS Rev. A 34
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Part and Serial Number Information on the Handpiece
LIT-PAL-CS Rev. A 35
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Part and Serial Number Information on the Console
LIT-PAL-CS Rev. A 36
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Part and Serial Number Information on the Cable
LIT-PAL-CS Rev. A 37
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Key Information for Service Needs
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
LIT-PAL-CS Rev. A 38
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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.
LIT-PAL-CS Rev. A 39
Phone: 800 722 0822 or +434 975 8000 Fax: 800 648 4309 or +434 975 4131
www.microaire.com
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