MicroAire LipoTower - User Manual

MicroAire LipoTower System
Instructions for Use

Summary

APPLICABLE PART NUMBERS

INTENDED USE

Defines the system's purpose for aesthetic body contouring.

INDICATIONS FOR USE

Lists surgical specialties where tissue fragmentation, emulsification, and aspiration are needed.

SYMBOL DEFINITIONS

INTRODUCTION

Introduces the document and its scope for operation and maintenance.

WARNINGS; CAUTIONS; NOTES

Explains the meaning of warning, caution, and note terms used in the IFU.

DESCRIPTION

IV;Tumescent Pole Assembly

Component for hanging IV bags and tumescent fluid.

Control and Display Interface

Includes control switches, LCD screen, and pressure adjustment.

Vacuum and Pump Controls

Features vacuum connections, tumescent pump controls, and foot switch ports.

System Components and Storage

Encompasses cooling fans, canister racks, shelves, and baskets.

Power and Connectivity

Includes power inlet, mains disconnect, and console connectivity.

TECHNICAL DESCRIPTION

Locking and Unlocking Casters

Instructions on how to lock and unlock the system's casters.

Connecting Power Console (Optional)

Steps for connecting optional power consoles like PAL.

INSTALLING THE IV;TUMESCENT POLE

ADJUSTING THE HEIGHT OF THE IV;TUMESCENT POLE

Explains how to adjust the height of the IV/Tumescent Pole.

CONNECTING THE BIOFILTER

ATTACHING WASTE CANISTERS

Details how to attach waste canisters and rings to the system.

CONNECTING FOOT SWITCHES

CONNECTING A SALINE;FLUID BAG TO THE TUMESCENT POLE

CONNECTING INFILTRATION TUBING

Steps for connecting infiltration tubing to the tumescent pump and fluid bag.

OPERATION

POWERING UP THE SYSTEM

Guides on how to safely power up the MicroAire LipoTower System.

TUMESCENT INFILTRATION CONTROLS

ASPIRATION CONTROLS

Explains the 3-way control switch and vacuum pressure adjustment.

LCD TOUCH SCREENS

BOOT-UP SCREEN

Describes the initial system startup screen.

HOME SCREEN

Overview of the main screen displaying vacuum pressure and tool options.

TOOLS SCREEN

Details the tools screen for biofilter hours, units, and reset.

MONITORING

ADDITIONAL SET UP AND INSTALLATION (OPTIONAL)

Covers optional setup procedures, including installing modules.

INSTALLING AN EXTRA SHELF

TROUBLESHOOTING

DIFFICULTY INSERTING CABLES

Provides solutions for issues with cable connections.

THE MICROAIRE LIPOTOWER SYSTEM WILL NOT POWER UP

Steps to resolve power-on issues with the system.

FOOT SWITCH WILL NOT OPERATE

Troubleshooting steps for a non-functional foot switch.

VACUUM PRESSURE IS INSUFFICIENT

Solutions for low vacuum pressure issues.

MICROAIRE LIPOTOWER SYSTEM CIRCUIT BREAKER IS TRIPPED

Guidance for when the system's circuit breaker trips.

CLEANING AND STERILIZATION

PREVENTIVE MAINTENANCE

ENVIRONMENTAL PARAMETERS

Specifies operating conditions for humidity, pressure, and temperature.

NOISE LEVEL EXPOSURE LIMITS

States the system's noise emission level.

SHIPPING AND STORAGE CONDITIONS

Outlines requirements for shipping and storing the device.

REPAIR AND WARRANTY

MICROAIRE REPAIR SERVICE

Provides contact information for repair and customer service.

RETURN PROCEDURE

WARRANTY

EXTENDED WARRANTY;SERVICE AGREEMENT

DISPOSAL

IEC 60601-1-2 COMPLIANCE SUMMARY

Guidance and manufacturers declaration - electromagnetic emissions

Guidance and manufacturers declaration - electromagnetic immunity

Electrostatic Discharge (ESD)

Guidance on immunity to electrostatic discharge.

Electrical fast transient;burst

Guidance on immunity to fast transients and bursts.

Surge

Guidance on immunity to power surges.

Voltage dips, short interruptions, and voltage variations

Guidance on immunity to power supply variations.

Power frequency (50;60 Hz) magnetic field

Guidance on immunity to power frequency magnetic fields.

Guidance and manufacturers declaration - electromagnetic immunity

Conducted RF

Guidance on immunity to conducted radio frequency disturbances.

Radiated RF

Guidance on immunity to radiated radio frequency disturbances.

Overview

1. Function Description
2. Usage Features
3. Maintenance Features

The MicroAire LipoTower System is a Class I, Type B medical device designed for continuous operation, specifically for aesthetic body contouring. Its primary function is to fragment, emulsify, and aspirate soft tissue, particularly subcutaneous fatty tissues. This system is intended for use in various surgical specialties, including Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, and Laparoscopic Surgery.

Function Description

The LipoTower System integrates aspiration and tumescent pump functionalities into a single mobile unit. The aspiration pump creates a vacuum to remove fragmented and emulsified tissue, while the tumescent pump infiltrates fluid into the target area to facilitate the liposuction process. The system's control switch allows for flexible operation of the vacuum pumps, offering three modes:

• BYPASS: The vacuum pumps remain continuously active.
• PAL CONTROL: The vacuum pumps activate when the Power-Assisted Liposuction (PAL) handpiece is in use. This mode requires a BNC cable connection between the LipoTower and the PAL electric console.
• FOOT SWITCH CONTROL: The vacuum pumps are activated by a foot switch.

A vacuum pressure adjustment knob allows the user to control the suction pressure, which is displayed on an LCD screen. The tumescent pump also features an ON/OFF switch and a speed adjustment knob to regulate the flow rate of infiltration fluid.

Usage Features

The MicroAire LipoTower System is designed for ease of setup and operation in a hospital or commercial environment.

• Mobility: The system is mounted on a cart with locking casters, allowing for easy positioning and stability during use. The casters should be locked during setup and operation to prevent movement.
• IV/Tumescent Pole: An adjustable IV/tumescent pole is integrated into the cart, capable of holding up to four saline/fluid bags. Each hook on the pole has a maximum safe capacity of 3kg (6.6lb).
• Canister Rack: The cart includes a canister rack designed to securely hold wall-mount style aspiration canisters or canister rings, accommodating various sizes of waste canisters.
• Biofilter Connection: The system incorporates a biofilter to prevent aspiration of surgical smoke or other particulate matter from devices like cauterizers or lasers, which could clog the filter. The biofilter tube connects to the main vacuum connection at the rear of the cart.
• Foot Switch Connections: Dedicated ports are available for connecting foot switches to control both the vacuum pumps and the tumescent pump, offering hands-free operation.
• Console Integration (Optional): The LipoTower can support MicroAire electric consoles (REF 1020/1025, REF 5020/5025) on a dedicated shelf. These consoles connect to the LipoTower via electrical cords and BNC cables, allowing for integrated control of PAL handpieces.
• LCD Screen: The LCD screen displays real-time vacuum pressure and provides access to "Tools" settings, which include biofilter and vacuum pump hour meters, and unit selection (inchHg or mmHg).
• Storage: The cart features both front and rear storage baskets for accessories and supplies.

Maintenance Features

The MicroAire LipoTower System requires routine maintenance to ensure safe and effective operation.

• Cleaning: The external surfaces of the device should be wiped down with a disinfectant after each procedure and at the beginning of each day. It is crucial to prevent fluid from dripping into any equipment openings. The system should never be sterilized, immersed, or washed.
• Biofilter Replacement: The BIOFILTER ASSEMBLY should be replaced approximately every 25 procedures, or sooner if performance is reduced due to clogging. Immediate replacement is necessary if any moisture is observed inside the filter or the tubing beyond it. The biofilter hour meter on the LCD screen should be reset after replacement.
• Inspection: All system components, including tubing and suction canisters, should be inspected for wear, damage, corrosion, or malfunction before each use. Any potential problems should be addressed by MicroAire.
• Cooling Fans: The system is equipped with cooling fans, which must not be blocked to prevent overheating.
• Troubleshooting: The manual provides guidance for common issues such as the system not powering up, foot switch malfunction, or insufficient vacuum pressure, often involving checking cable connections, switch positions, and biofilter status.
• Servicing: The MicroAire LipoTower System is field-repairable only. Disassembly or unauthorized servicing will void the warranty. Repairs and alterations must be performed by MicroAire or an authorized repair agent.
• Environmental Considerations: The system is designed for operation within specific relative humidity, atmospheric pressure, and temperature limits. It should not be used in the presence of flammable anesthetics or oxygen. Precautions against electrostatic discharge (ESD) are also outlined, recommending the use of antistatic materials or increased humidity in synthetic-floored environments.
• EMC Compliance: The system is designed to comply with IEC 60601-1-2 standards for electromagnetic emissions and immunity, ensuring its safe operation in typical medical environments.

MicroAire LipoTower Specifications

General

Category	Medical Equipment
Type	Liposuction System
Manufacturer	MicroAire Surgical Instruments
Power Source	Electric
Warranty	1 year
Suction Pressure	Up to 29 inHg
Tubing Connection	Standard