PAL LIPOTOWER Instructions for Use Rev F

APPLICABLE PART NUMBERS REF Number

Description

REF ASP-1021 REF ASP-TUM REF ASP-CBL-1020 REF ASP-CBL-5020 REF ASP-FLTR REF ASP-RNG-1200 REF ASP-RNG-2000 REF ASP-TB-VAC REF ASP-TB-TUM REF ASP-FOOT-1 REF ASP-SHLF-1 REF PAL-600E REF PAL-650 REF 1020 REF 1025 REF 5020 REF 5025 REF PAL-900 REF PAL-1200 REF 1006-PALE REF 5006-PAL

LipoTower with Aspiration Pump and Tumescent Pump Tumescent Pump Module Cable - 1020/1025 to LipoTower Cable - 5020 to LipoTower Biofilter and Tubing Assembly Canister Ring 1200cc Canister Ring 2000cc Tubing - Vacuum (Non-Sterile) Luer Single-Use Tumescent Infiltration Tubing, Single-Spike, 10 Pak Foot Pedal Shelf Power-Assisted Liposuction Handpiece Power-Assisted Liposuction Handpiece PAL Electric Power Console Instrument Power Console iSIS Electric Power Console for PAL iSIS Electric Power Console for MicroAire Instruments Liposuction Tubing (9-foot) Liposuction Tubing (12-foot) PAL Instrument Cable for REF 1020/1025 PAL Instrument Cable for REF 5020/5025

INTENDED USE The MicroAire LipoTower System is a device intended for aesthetic body contouring.

INDICATIONS FOR USE The MicroAire LipoTower System is indicated for use in the following surgical specialties when the fragmentation, emulsification and aspiration of soft tissue is desired: • • • • • • • • •

Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery

The MicroAire LipoTower System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

SYMBOL DEFINITIONS

   

TYPE B EQUIPMENT ATTENTION SEE INSTRUCTIONS FOR USE DO NOT LUBRICATE DO NOT IMMERSE ELECTROSTATIC SENSITIVE DEVICE

h

PRODUCT CATALOG NUMBER



DO NOT REUSE

M

MANUFACTURER



DATE OF MANUFACTURE (YYYY-MM)

f

SERIAL NUMBER

   5

RELATIVE HUMIDITY LIMITS ATMOSPHERIC PRESSURE LIMITS TEMPERATURE LIMITS UL LISTING

INTRODUCTION This document, MicroAire LipoTower System - Instructions For Use (IFU), is intended to describe the procedures required to safely operate, clean and maintain the REF ASP-1020, the REF ASP-1021. The operation, maintenance, cleaning and sterilization procedures for the PAL-650 Power Assisted Lipoplasty Handpiece, the 1020/1025 Standard Electric Console and the 5020/5025 Electric Console are described in their respective IFUs. This IFU addresses primarily the operation, maintenance cleaning and sterilization procedures applicable to the MicroAire LipoTower System. The MicroAire LipoTower System can be configured to meet the requirements of an individual surgeon. See SETUP section for details on system configuration. WARNINGS / CAUTIONS / NOTES Throughout this IFU, the following terms are used to identify operational hints as well as precautions that will help avoid accidental injury to patients or personnel, or to prevent damage to delicate powered instruments. WARNING: CAUTION: NOTE:

Used to indicate that the safety of patients and hospital personnel could be involved. Used to point out special procedures or precautions that must be complied with to avoid damaging an instrument. Used to point out the easiest means of carrying out the techniques. 1

WARNING: Explosion hazard. Do not use in the presence of flammable anesthetics or oxygen. WARNING: The MicroAire LipoTower System is heavy, weighing approximately 190 pounds. Use the proper equipment to lift the system if required. WARNING: Flat shelving capacity – 6.8 kg (15lb) maximum safe capacity. Do not exceed. WARNING: Tumescent pole capacity - 3kg (6.6lb) maximum safe capacity per hook. Do not exceed. WARNING: Do not transport cart with anything on shelves or hooks. Remove all items from cart before unlocking casters. WARNING: Do not modify any accessory. Failure to comply may result in patient and or operating room staff injury and equipment damage. WARNING: Use only MicroAire-approved accessories. Use of other unapproved accessories may result in increased emissions or decreased immunity of the system and will void your warranty. WARNING: This device will not, in and of itself, produce significant weight reduction. WARNING: This device should be used with extreme caution in patients with chronic medical conditions, such as diabetes, heart, lung or circulatory system disease or obesity. WARNING: The volume of blood loss and endogenous body fluid loss may adversely affect intra and/or postoperative hemodynamic stability and patient safety. The capability of providing adequate, timely replacement is essential for patient safety. WARNING: Grounding reliability can only be achieved when the equipment is connected to an equipment receptacle marked “Hospital Only” or “Hospital Grade.” WARNING: Disconnecting the supply cord will isolate the system from the supply mains on all poles simultaneously. WARNING: Inspect tubing and suction canisters for wear or damage before use. WARNING: Risk of fire. Use only MicroAire cables to connect to this device. WARNING: Electric shock. Do not remove cover; refer servicing to qualified personnel only. WARNING: Use care to ensure that there is no electromagnetic interference between this device and other devices in use. WARNING: Casters must be locked to prevent movement during normal use when a canister containing fluid is installed on the canister rack. Do not roll or tilt the cart in this condition because fluid could spill onto the cart causing a hazardous situation. WARNING: ESD (Electromagnetic environment – guidance): Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. If ESD-related issues are experienced during use, it may be necessary to use antistatic materials (e.g., anti-static mat) or to increase the relative humidity of the surrounding environment.

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WARNING: EFT (Electromagnetic environment – guidance): Mains power quality should be that of a typical commercial or hospital environment. If EFT-related issues are experienced during use, the use of power-line filtering may be necessary to ensure proper operation in the presence of large power-line transients. WARNING: Do not block cooling vents. Maintain 50mm MIN clearance. CAUTION: This device is designed to contour the body by removing localized deposits of excess fat through small incisions and subsequently transfer the tissue back to the patient. CAUTION: Do not leave cannulas in patient when not in use. CAUTION: Use of this device is limited to those physicians who, by means of formal professional training or sanctioned continuing medical education (including supervised operative experience), have attained proficiency in suction lipoplasty and tissue transfer. CAUTION: Results of this procedure will vary depending on patient age, surgical site and experience of the physician. CAUTION: Results of this procedure may or may not be permanent. CAUTION: The amount of fat removed should be limited to that necessary to achieve a desired cosmetic effect. CAUTION: All reusable components of the device must be sterilized and all disposable components replaced before using the device system on another patient. CAUTION: Federal Law restricts this device to sale by, or on the order of, a physician (or properly licensed practitioner). CAUTION: See “PAL-650 Instrument System Instruction Manual” for detailed information on the PAL-650 handpiece. CAUTION: See “Model 1020 Standard Electric Console Instruction Manual” for detailed information on the Model 1020 Standard Electric Console. See “Model 5020 Standard Electric Console Instruction Manual” for detailed information on the Model 5020 Standard Electric Console. CAUTION: Do not use this device to aspirate surgical smoke from devices such as cauterizers, lasers, electrosurgical instruments or ultrasonic units. Doing so may clog the biofilter. NOTE: This device is intended only for the aspiration of tissue or fluid from the body. The tissue product collected by this device shall only be used with FDA exempt/cleared/approved devices for any further use other than disposal. NOTE: All personnel involved with the operation, cleaning, maintenance and cleaning of the REF ASP-1020, -1021, should become familiar with the power equipment before it is set up for use in any procedure. Personnel that are trained should include, but not be limited to, central processing personnel, members of the surgical team, and the bioengineering department. NOTE: The MicroAire LipoTower System should only be used with compatible FDA cleared tubing, handpieces and cannulas. NOTE: The MicroAire LipoTower System has been tested for sound level and does not exceed 70 dB(A).

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DESCRIPTION

1. IV/TUMESCENT POLE 2. CONTROL SWITCH • Determines the source of ON/OFF functions of the vacuum pump. • BYPASS - Vacuum pumps stay on. • PAL CONTROL - Vacuum pumps are on when PALhandpiece is on. This requires a BNC cable (REF ASP-CBL-1020, or REF ASPCBL-5020) to be connected. (See Figure 4). • FOOT SWITCH CONTROL - Vacuum pumps are on when footswitch is activated.

1

2 3 4 5

3. LCD SCREEN • Displays vacuum pressure and Tool settings. 4. VACUUM PRESSURE ADJUSTMENT • MAX - For maximum vacuum turn clockwise. • MIN - For minimum vacuum turn counter-clockwise.

6

5. STANDBY SWITCH • ON ( | ) allows pumps to be activated by the Control Switch. • STANDBY ( o ) turns vacuum pumps off.

7

6. STORAGE BASKET 7. LOCKING CASTERS 8. PUSH HANDLE 9. MAIN VACUUM CONNECTION 14

10. REAR STORAGE BASKET 11. POWER INLET AND MAINS DISCONNECT SWITCH 12. FOOT SWITCH CONNECTION

8 15 16 17 18 19

9

10

14. CANISTER RACK • Designed to securely hold wall-mount style aspiration canisters or wall-mount style canister rings. 15. TUMESCENT PUMP ON/OFF SWITCH 16. TUMESCENT PUMP SPEED ADJUSTMENT KNOB 17. TUMESCENT PUMP FOOT SWITCH CONNECTION 18. TUMESCENT PUMP MODULE • Standard on model ASP-1021 only. To add module, use REF ASP-TUM.

11

12 4

13. COOLING FANS • Do not block cooling fans or system may overheat.

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19. SHELF • Supports MicroAire electric consoles (REF 1020/1025, REF 5020/5025)

TECHNICAL DESCRIPTION The MicroAire LipoTower System is Class I, Type B equipment, designed for continuous operation. It should not be used in the presence of flammable anesthetics. This equipment is rated IPX0 and provides no protection against the ingress of solids or liquids. This equipment provides suction for health care facilities and is not intended for use in the field or during transport. Rating: 100-120V ~ 60 Hz 1200VA Output: 360VA

Maximum suction: 27-29 inHg (685.8-736.6 mmHg) at sea level Maximum continuous run time: 90 minutes

SETUP WARNING: To avoid personal injury, always ensure that the system is disconnected from applicable energy sources before starting any procedure in this section. CAUTION: Some components may be Electrostatic Sensitive. Observe precautions for handling Electrostatic Sensitive Devices. 1. LOCKING AND UNLOCKING CASTERS 1. The front casters can be locked by depressing the brake tab that is connected to the caster. (Figure 1) 2. The front casters can be unlocked by lifting the brake tab that is connected to the caster. (Figure 2)

Figure 1 - Lock the casters

Figure 2 - Unlock the casters

Figure 3 - Install optional console

Figure 4 - Unscrew back-cover screws

NOTE: Casters should be locked during set up and operation. 2. CONNECTING A MICROAIRE POWER CONSOLE FOR PAL SYSTEM (OPTIONAL)

1. Place Electric Console (REF 1020/1025 or REF 5020) on the shelf. (Figure 3) 2. Remove the back cover panel on the upper rear of the cart by loosening the two retaining screws. (Figures 4 and 5) 3. Manuever the electrical cord from the REF 1020/1025 or REF 5020 through the cable opening and connect it to the hospital grade outlet on the back of the Figure 5 - Remove back panel cart. (Figure 6) 4. Manuever the BNC cable from the REF 1020/1025 or REF 5020 through the cable opening and connect it to the port on the back of the cart. (Figure 7) 5. Replace the rear cover and tighten the two retaining screws. CAUTION: The Hospital Grade Receptacle has maximum current limit of 3A. Do not exceed. CAUTION: This panel is in place for safety. Only UL-approved, PAL-related MicroAire cables are to be used to connect to the receptacles within the system. Ensure cover is securely attached before connecting power.

Figure 6 - Plug console into outlet

Figure 7 - Attach BNC connector 5

INSTALLING THE IV/TUMESCENT POLE 1. Insert the IV/Tumescent Pole into the receptacle on the top of the cart, in the rear left corner. Make sure that the sheathed wires within the recptacle are positioned toward the front of the cart while lowering the pole carefully into position. (Figure 8) 2. Turn the pole clockwise to thread it into position, and stop turning when it is snug. ADJUSTING THE HEIGHT OF THE IV/TUMESCENT POLE

Figure 8 - Install IV Pole

Figure 9 - Adjust pole height

1. Move the locking collar upwards; then the pole can be adjusted up or down. The pole will stay in position once the locking collar is released. (Figure 9)

CONNECTING THE BIOFILTER 1. Locate the small black Tubing Clip on the side of the Canister Rack. 2. Push the Biofilter tube into the Tubing Clip so it is secured in place with the Biofilter resting upon the clip, with the tubing exiting downward. (Figure 10) 3. Guide the loose end of the Biofilter tubing toward the rear of the cart, beneath the Canister Rack, and connect it to the Main Vacuum Connection. (Figure 11)

Figure 10 - Install Biofilter

Figure 11 - Connect vacuum

ATTACHING WASTE CANISTERS 1. Locate the Canister Rack on the top of the cart. Slide Figure 12 - Install waste one or more Waste-Canister Rings (REF ASP-RNG-1200 canister rings or REF ASP-RNG-2000) into any of the four available canister slots. These slots also accept various wallmount style waste canisters. (Figure 12) 2. Insert appropriately sized Waste Canister into Ring. (Figure 13) 3. Connect Waste Canister to the Biofilter using REF ASP-TB-VAC Non-Sterile Vacuum Tubing. (Figure 14)

Figure 13 - Insert canister

WARNING: Use only canisters that are rated appropriately for the vacuum pressure that will be used. Figure 14 - Connect short tube from canister to filter

CONNECTING FOOT SWITCHES 1. Connect a Foot Switch to the lower rear of the cart to control the ON/OFF function of the vacuum pumps when the CONTROL SWITCH is set to FOOT SWITCH. (Figure 15) 2. Connect a Foot Switch to the Tumescent Pump module on the side of the cart, (where applicable) to control the ON/OFF function of the Tumescent Pump when the Tumescent Switch is in the ON position. (Figure 16) 6

Figure 15 - Connect Foot Switch to rear of cart to control vacuum pumps

Figure 16 - Connect Foot Switch to side of cart to control infiltration

CONNECTING A SALINE/FLUID BAG TO THE TUMESCENT POLE 1. Hang a sterile saline/fluid bag onto the Tumescnt Pole by carefully inserting the bag’s hanging-grommet onto one of the four hooks on the Tumescent Pole (Figure 17 and 18). Up to four bags can be hung at one time, with one on each hook.

Figure 17 - Attach saline/fluid bag to the Tumescent Pole

Figure 18 - Make surethe bag is securely attached to the hook.

WARNING: Ensure that saline bags are properly secured to the hook. WARNING: Tumescent pole maximum safe weight capacity is 3kg (6.6lb) per hook. Do not exceed. CONNECTING INFILTRATION TUBING 1. Attach sterile, single-spike infiltration tubing (REF ASP-TB-TUM) to the saline/ fluid bag according to the instructions for the saline/fluid bag. 2. Lift the lid on the Tumescent Pump located on the side of the cart. (Figure 19) Figure 19 - Open the Tumescent Pump Figure 20 - Insert Infiltration Tubing 3. Locate the soft silicone section of infiltration tubing and place it into the open pump, ensuring that the outward flow of fluid is exiting the pump towards the front of the cart. (Figure 20) 4. Close the lid on the Tumescent Pump to compress the Infiltration Tubing within the pump.

OPERATION WARNING: Prior to use, all MicroAire Power Assisted Lipoplasty System subsystem manuals should be reviewed for important warnings and instructions for use. WARNING: Prior to use, all system components should be inspected to detect any damage, excessive wear, corrosion or malfunction. DO NOT use if any potential problems become apparent. Contact MicroAire for resolution. WARNING: Eye protection must be worn when operating any power equipment. Dislodged burs, blades or bone fragments can result in eye injury, blindness, or contamination of the eye from patient tissue or body fluids. POWERING UP THE SYSTEM 1. Before plugging the wall outlet power cord into a hospital-grade wall outlet, ensure that the STANDBY switch on the front of the cart is in the “STANDBY” ( o ) position. (Figure 21) 2. Insert the electrical cord into the POWER INLET, located on the lower left of the rear of the cart (Figure 22). Plug the power cord into an appropriate hospital-grade wall outlet. 3. To power up the MicroAire LipoTower System, push the Mains Power Disconnect Switch to the “ON” ( | ) position (Figure 22). A visible light on the STANDBY switch will now be illuminated. 4. Push the STANDBY switch to the “ON” ( | ) position. An audible sound from the cooling fans will indicate that the MicroAire LipoTower System is powered up.

Figure 21 - Standby switch

Figure 22 - Power inlet and Mains Disconnect switch 7

TUMESCENT INFILTRATION CONTROLS 1. Turn on the Tumescent Pump using the ON/OFF switch on the side of the cart. (Figure 23) 2. Adjust the speed/flow rate of the pump by turning the Speed Adjustment Knob. Flow rate is increased by turning the knob clockwise, and speed is decreased by turning the knob counterclockwise (Figure 24)

Figure 23 - Tumescent Pump ON/OFF

Figure 24 - Speed Adjustment knob

ASPIRATION CONTROLS 1. The 3-WAY CONTROL SWITCH controls the ON/OFF status of the MicroAire LipoTower System vacuum pumps. (Figure 25)

• • •

BYPASS (left position) makes the Figure 25 - Three-Way Control Switch Figure 26 - Vacuum Pressure Knob vacuum pumps continuously active; PAL (middle position) places the ON/ OFF status of the pumps under the control of the throttle of the MicroAire PAL handpiece; FOOT SWITCH (right position) places the ON/OFF status of the pumps under the control of a foot switch.

NOTE: If “FOOT SWITCH” is selected, ensure that the foot switch cable is securely connected to its receptacle located on the lower rear of the MicroAire LipoTower System. Ensure that the foot switch pedal is located within reach of the operator. 2. The VACUUM PRESSURE ADJUSTMENT knob controls the amount of suction pressure. Vacuum pressure is displayed on the LCD screen. Suction is increased by turning the knob clockwise towards MAX, and suction is decreased by turning the knob counterclockwise towards MIN. (Figure 26) LCD TOUCH SCREENS BOOT-UP SCREEN The MicroAire logo will appear while the system is starting up. After boot-up, the screen will automatically advance to the home screen. HOME SCREEN

Figure 27 - Home Screen

Figure 28 - Tools Screen

This screen displays vacuum pressure, and an option to select the Tools screen. (Figure 27) TOOLS SCREEN This screen shows the number of hours used by the Biofilter, a button to reset the Biofilter to Zero, the number of total hours used by the vacuum pump, and buttons to select the unit of measurement. (Figure 28)

• • •

Reset the biofilter hour meter by selecting RESET BIOFILTER TO ZERO. Select preferred units of measurement by choosing “INCH” or “MM.” To return to the Main Screen, select the Back icon (left-facing arrow).

NOTE: The vacuum hour meter is not resettable, it represents total time used by the vacuum pumps. 8

MONITORING Primary monitoring of the MicroAire LipoTower System status will be accomplished by observing progress at the procedure site of the patient. Secondary monitoring of the MicroAire LipoTower System status will be accomplished by periodic viewing of the tumescent fluid bags, the Tumescent Measuring Device (where applicable), the vacuum pressure as displayed on the LCD screen, and by viewing the waste canisters, to verify functionality as well as volume of aspirant. CAUTION: Waste canisters should be replaced when 90% full. Overfilling may result in aspirant matter getting into, and contaminating, the MicroAire LipoTower System. Once the MicroAire LipoTower System is powered up, and its appropriate cables, tubing, waste canisters and biofilter properly connected, and its mode of operation selected, and once the REF PAL-650 or PAL-600 and the REF 1020/1025 or REF 5020 have been properly powered and connected in accordance with their respective IFUs, surgical procedures can be started. CAUTION: Before use, verify that the MicroAire LipoTower System functions properly. If not, contact MicroAire for resolution.

ADDITIONAL SET UP AND INSTALLATION (OPTIONAL) INSTALLING THE TUMESCENT MODULE 1. Turn off power and disconnect main power by unplugging power cord. 2. Locate the Tumescent Bay cover on the left side of the cart. Remove the the two retaining screws and slide the cover towards the back of the cart to disengage the clip that is near the front of the cart. Remove cover. (Figure 29) 3. Locate the electrical connector harness on the pump module and connect it to the corresponding electrical connector within the bay. (Figure 30) 4. Insert the Tumescent Module (REF ASP-TUM) into the tumescent bay by inserting the pump module and then sliding it towards the front of the cart to engage the retaining clip. (Figure 31) 5. Insert the two retaining screws to secure the module in the bay. Do not tighten the screws until both are in place, to allow for adjusting the levelness of the module. (Figure 32) 6. Align the slot on the peristaltic pump head with the drive shaft, then attach the pump head. (Figure 33) 7. Rotate the pump head clockwise until it clicks into place. (Figure 34)

Figure 29 - Remove screws and slide cover towards the back of the cart.

Figure 30 - Connect the electrical harness.

Figure 31 - Insert the module. Slide it rightward to engage retaining clip.

Figure 32 - Replace retaining screws.

Figure 33 - Align the slot on the pump head with the drive shaft.

Figure 34 - Rotate the pump head clockwise until it clicks into place.

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INSTALLING AN EXTRA SHELF 1. Turn off power and disconnect main power by unplugging power cord. 2. Insert the shelf from the front of the cart toward the rear and line up the bolt holes. 3. Insert the four bolts and use a 5/32” Allen wrench to tighten the bolts until they are snug.

TROUBLESHOOTING DIFFICULTY INSERTING CABLES • Align connectors and receptacles carefully. • Make sure that all markings on cable plugs are aligned with matching markings on receptacles. • If difficulty persists, contact MicroAire Customer Service for additional troubleshooting and repair. THE MICROAIRE LIPOTOWER SYSTEM WILL NOT POWER UP • Position the MAINS DISCONNECT SWITCH, located on the rear of the MicroAire LipoTower System to the OFF position. Ensure that the power cord is fully seated in the wall outlet. Position the MAINS DISCONNECT SWITCH to the ON position. • Verify that the STANDBY switch is in the ON position. • If the unit is still not operating properly, contact MicroAire Customer Service for additional troubleshooting and repair. FOOT SWITCH WILL NOT OPERATE • Ensure that the foot switch connection tube is fully seated in its receptacle at the lower rear of the MicroAire LipoTower System. • Ensure that the vacuum pump CONTROL SWITCH is in the FOOT SWITCH position. • If the foot switch still does not operate properly, contact MicroAire Customer Service for additional troubleshooting and repair. VACUUM PRESSURE IS INSUFFICIENT • Ensure all aspiration canisters and aspiration lines are properly connected and not kinked, and all aspiration canister lids are properly installed, with no clogged filters. • Check the biofilter to ensure it is not clogged. • Ensure that all applicable component connections are secure (the foot switch, REF PAL-650 handpiece, REF 1020/1025 and REF 5020 electric console); and that the 3-WAY CONTROL SWITCH is properly set. • If vacuum pressure is still insufficient, contact MicroAire Customer Service for additional troubleshooting and repair. MICROAIRE LIPOTOWER SYSTEM CIRCUIT BREAKER IS TRIPPED • Check the biofilter to ensure it is not clogged. • Cycle the MAINS DISCONNECT SWITCH to the OFF position and then to the ON position. • If the Circuit Breaker trips again, contact MicroAire Customer Service for additional troubleshooting and repair. CLEANING AND STERILIZATION WARNING: The MicroAire LipoTower System should never be sterilized, immersed, or washed. Before cleaning, the MicroAire LipoTower System should be unplugged. External surfaces of the device should be carefully wiped down with a disinfectant after each procedure, and at the beginning of each day. Care should be taken not to drip fluid into any equipment openings. WARNING: If any fluid or solid material is drawn into the vacuum pump, the equipment must be serviced. 10

MULTI-USE CANNULA CLEANING AND STERILIZATION INSTRUCTIONS CAUTION:

DO NOT sterilize single-use cannula. The connector will warp or crack.

WARNING:

Universal precautions for handling contaminated materials should be observed at all times.

CAUTION:

DO NOT utilize cleaning solutions that are not mild pH, unless they are approved for use with anodized aluminum and surgical instruments.

CAUTION:

DO NOT utilize cleaning agents with chlorine or chloride as the active ingredient is corrosive to stainless steel.

CAUTION:

DO NOT utilize cleaning agents that are phenol based.

CAUTION:

MicroAire powered surgical instruments (including multi-use cannulae) are normally sterilized by steam, using either a gravity displacement or pre vacuum autoclave sterilizer.

WARNING:

Sterilizers vary in design and performance parameters. Verify cycle parameters against the written instructions of the sterilizer and container manufacturers. Pre vacuum sterilization is the preferred method of sterilization for powered surgical instruments because it allows for rapid sterilization of the internal components.

CAUTION:

Automatic cleaning is NOT recommended.

CAUTION:

Usage beyond maximum intended re-use will reduce performance and increase wear on handpiece.

WARNING:

Failure to comply with maximum intended re-use may result in injury to patients and health care professionals.

WARNING:

Multiple-use cannulas should not be used for procedures in which tissue is harvested for reinjection.

Limitations on Reprocessing Multiple–use Cannulas are intended for limited re-use with a maximum intended re-use of 15-20 cases when processed according to the instructions below.

1. At Point of Use Disassemble the cannulae from the instrument and disposable tubing. Remove excess body fluids and tissue with a disposable, non-shedding wipe and place cannulae in a basin with warm water and a mild detergent. Body fluids and tissue should not be allowed to dry on cannulae prior to cleaning. NOTE: It is recommended that instruments be cleaned within 30 minutes of end use to minimize the potential for organic material drying on the instrument prior to cleaning 2. Preparation for Decontamination Locate the appropriate sized soft bristled cylindrical brush and/or stylet. Stylets are commonly used in smaller diameter cannulae where the inner lumen is too small to fit a cylindrical brush. The brush and/or stylet should be long enough to easily reach the tip of the cannula. The bristles of the brush should be wide enough to fill the lumen but still be able to move freely. 3. Preparation of Cleaning Agent Prepare mild pH enzyme cleaning agents at the maximum use-dilution and temperature recommended by the manufacturer. Determination of cleaning agents shall be by local or country regulations. 11

4. Cleaning: Automated a. Fully submerge the cannulae in the enzymatic cleaning agent. Using a syringe, flush the cannulae with enzyme cleaning agent and water to remove debris and any blockages. b. Clean the inside diameter of each cannula shaft (lumen), while still submerged in the enzymatic cleaning agent, using the appropriate sized soft bristled cylindrical brush and/or stylet. The inside diameter of each cannula is to be cleaned until no visible debris comes out of the tip of each cannula or out of the back of each cannula where the brush and/or stylet is inserted. c. Load the cannulae into the washer-disinfector. d. Connect cannulae to the rinsing ports of the washer-disinfector. If there is no direct connection, place the cannulae directly on injector jets or in injector sleeves of the injector basket. Arrange cannulae so that the cannulations are not horizontal and openings are oriented downwards (to assist drainage). Avoid contact between devices (movement during washing could cause damage, and the washing action could be obstructed). e. The minimum recommended washer-disinfector cycle is listed in the chart below: #

Title

Detergent

Minutes

Temp

1

Pre-Wash

Mild pH Enzymatic*

4

< = 50 °C (122 °F)

2

Rinse

None

1**

< = 50 °C (122 °F)

3

Wash

Mild pH

4

> = 60 °C (140 °F)

4

Drain

5

Rinse

None

2**

> = 60 °C (140 °F)

6

Drain

7

Thermal Disinfect

None

10

> = 93 °C (200 °F)

None

6

> = 100 °C (212 °F)

8 Drain 9

Dry

* Detergent can be omitted at the pre-wash stage if the equipment does not have this ability. ** If not using mild Ph detergent, extend rinse time if possible to reduce possible degradation. NOTE: Washers/Disinfectors should comply with the requirements of ISO 15883. They should be properly installed and be regularly tested in accordance with ISO 15883. f. Upon completion of the washer-disinfection cycle, remove the cannulae from the washer-disinfector. Visually inspect each cannula inner shaft, outer shaft, hub and all recessed features to ensure all visible blood and debris has been removed. If blood or debris remains, repeat the entire automatic cleaning process. 5. Cleaning: Manual with Ultrasonic a. Using a syringe, flush the inside diameter of each cannula shaft (lumen) with the enzymatic cleaning agent and soak the cannulae for 20 minutes in the enzymatic cleaning agent. b. Scrub the hub and exterior cannula shaft with a soft bristled brush while submerged in the enzymatic cleaning agent until all visible debris has been removed from the exterior surfaces.

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c. Clean the lumen of each cannula using the appropriate sized soft bristled cylindrical brush and/or stylet, while submerged in the enzymatic cleaning agent. A syringe may be used to aid in cleaning the lumens. The inside diameter of each cannula is to be cleaned until no visible debris comes out of the tip of each cannula or out of the back of each cannula where the brush and/or stylet is inserted. d. Place the cannulae in an ultrasonic bath (40 kHz) for an additional 20 minutes in enzymatic cleaning agent. Ensure that the instruments are completely immersed in cleaner. e. Remove cannula from bath and rinse all items thoroughly under running (<50 °C / 122 °F) water for a minimum of 2 minutes. f. Use a syringe to flush the lumen of the cannulae with lukewarm tap water. If possible, use distilled water for the final rinse. g. Upon completion of the manual cleaning, visually inspect each cannula inner shaft, outer shaft, hub and all recessed features to ensure all visible blood and debris has been removed. If blood or debris remains, repeat the entire manual cleaning process. 6. Disinfection Disinfection is only acceptable as an adjunct to full terminal sterilization for Multi-Use surgical instruments. See sterilization section below. 7. Drying Wipe off any water from the cannula with a soft lint-free towel. An air gun can also be used. 8. Maintenance, Inspection and Function Testing a. Carefully inspect each device to ensure that all visible blood and debris has been removed. b. Visually inspect for damage and/or wear. c. Check the action of moving parts to ensure smooth operation throughout the intended range of motion. d. Where instruments form part of a larger assembly, check that the devices assemble with mating components. NOTE: If concerns are noted that may compromise the function of the device, please contact your MicroAire representative. 9. Packaging a. Single Instruments - A standard medical grade steam sterilization wrap may be used. Ensure that the wrap is large enough to contain the instrument without stressing the packaging (ANSI/AAMI ST79, EN ISO 17665-1). b. Sets of Instruments - 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). 10. Sterilization Steam sterilize using one of the following cycles: a. Pre vacuum Steam Sterilization for a single device or in a sterilization tray: 4 minute Full Cycle at 132-135 °C (270- 275 °F), 20 minute minimum heated dry time b. Gravity Displacement Steam Sterilization for a single device or in a sterilization tray: 35 minute Full Cycle @ 132 - 135 °C (270-275 °F), 15 minute minimum heated dry time

WARNING: Proper disposal of all tubing, waste canisters and other disposable products exposed to human tissue is required. Dispose of all waste properly in appropriate biohazard waste receptacles as required by local, state and federal regulations.

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PREVENTIVE MAINTENANCE The MicroAire LipoTower System requires the following preventive maintenance:

• • •

The BIOFILTER ASSEMBLY should be replaced after approximately every 25 procedures, or sooner if performance is reduced by clogging. If the BIOFILTER ASSEMBLY shows any moisture inside the filter or in the tubing beyond the filter, it should be changed immediately. Replace with MicroAire part REF ASP-FLTR and reset the hour meter in the TOOLS window of the LCD screen. All MicroAire equipment should be inspected and tested periodically in accordance with the user facility’s bioengineering policy. Such service should be documented within the bioengineering department, and on the equipment (evidenced by an appropriate sticker).

WARNING: Repairs or alterations to MicroAire products made by anyone other than MicroAire or an authorized MicroAire repair agent, will void the product’s warranty.

ENVIRONMENTAL PARAMETERS OPERATING CONDITIONS



106

<

91%

Relative humidity limits

r

-18:

86

10%

49:

Atmospheric pressure limits

Temperature limits

WARNING: If there is condensation present on the MicroAire LipoTower System, DO NOT use it. Wait for the unit to come to room temperature and for condensation to evaporate before use. WARNING: If the MicroAire LipoTower System is operated at high elevation or low atmospheric pressure, aspiration performance may be adversely affected. NOISE LEVEL EXPOSURE LIMITS The A-weighted emission sound pressure level of the MicroAire LipoTower System operating under normal conditions does not exceed 70 dB(A).

SHIPPING AND STORAGE CONDITIONS SHIPPING: The materials and components used in the construction of this device were selected to insure that the device could be shipped by any standard commercial method without special handling conditions. STORAGE: Device should be stored in a designated, limited-access area that is well ventilated and provides protection from dust, moisture, insects, vermin and temperature/humidity extremes.

REPAIR AND WARRANTY MICROAIRE REPAIR SERVICE Responsive service comes with every MicroAire product. If a problem should arise with your equipment, contact our Customer Service Department at: Telephone Fax Email

800-722-0822 800-438-6309 [email protected]

Mailing Address

MicroAire Surgical Instruments LLC 3590 Grand Forks Boulevard Charlottesville, VA 22911, U.S.A.

DO NOT disassemble or attempt to service the equipment. It can only be serviced by MicroAire, or an authorized MicroAire repair agent. Unauthorized service will void the warranty. 14

RETURN PROCEDURE The MicroAire LipoTower System is field-repairable only, and should not be returned to the factory. WARRANTY MicroAire Surgical Instruments warrants its LipoTower System to be free from defects in material and workmanship in their manufacture for a period of one year from the original purchase date by the end customer. The warranty is limited to the repair or replacement of the product without charge. This warranty is void in the event of abuse, misuse, or use in other than normal surgical environments, or in the event of disassembly, alteration, or repair of the product not authorized by the manufacturer, or in the event that the product has not been used in a reasonable manner and in compliance with the written instructions furnished by the manufacturer. All other expressed or implied warranties of fitness and merchantability are excluded here from, and the manufacturer shall have no liability of any kind for incidental or consequential damages. EXTENDED WARRANTY/SERVICE AGREEMENT Extended warranties and service agreements are available on MicroAire power equipment. Extended warranties may be purchased while the equipment is covered by the original warranty. If the equipment is out of warranty, it must first be restored, if necessary, to full serviceable condition before being eligible for a service agreement.

DISPOSAL Follow local regulations for proper disposal.

IEC 60601-1-2 COMPLIANCE SUMMARY CAUTION: The MicroAire LipoTower system needs to be installed and put into service according to the EMC information provided in this Instructions for Use manual. Portable and mobile RF communications equipment can affect medical electrical equipment. The MicroAire LipoTower System may be interfered with by other equipment with CISPR emission requirements. CAUTION: The pin of the BNC connector of the MicroAire LipoTower System should not be touched and connection to this port should not be made unless ESD precautionary procedures are used. CAUTION: Electrostatic Discharge (ESD) can damage electronic equipment. Under certain conditions, ESD may build up on your body or an object and then discharge into another object. To prevent ESD damage, you should discharge static electricity from your body before interacting with the MicroAire LipoTower System. You can protect against static-electricity discharge from your body by touching a metal grounded object before you interact with anything electronic. It is recommended that all staff involved with this device receive an explanation of the ESD warning symbol and training in ESD precautionary procedures. CAUTION: The use of accessories and cables other than those specified in the Accessories list of this Instructions for Use manual may result in increased emissions or decreased immunity of the equipment or system. CAUTION: The MicroAire LipoTower system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or system must be observed to verify normal operation in the configuration in which it will be used.

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Table 1 (IEC 60601-1-2 Table 201)

Table 2 (IEC 60601-1-2 Table 202)

16

Table 3 (IEC 60601-1-2 Table 204)

Table 4 (IEC 60601-1-2 Table 206)

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M MicroAire Surgical Instruments LLC 3590 Grand Forks Blvd Charlottesville, VA 22911 USA Telephone (800) 722-0822 (434) 975-8000 Fax (800) 648-4309 (434) 975-4131 www.microaire.com

5 © 2016 MicroAire Surgical Instruments LLC Printed in the USA IM-LIPOTOWER REV F