The VASERlipo System Users Guide

VA S E R ® a n dTVA E RS P r ol i p Aom™pSl iyfsi et er mU s e r ’ s G u i d e h e SVA ER

This user’s guide and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed. Caution:

U.S. Federal Law restricts this device to sale to or on the order of a physician.

Equipment covered in this User’s Guide: VASER Amplifier VASER Pro Amplifier* VASER Ultrasound Footswitch Main Power Cord VASER Accessory Power Cord VASER Back Panel** VASER Power Cord Adapter** *

T  he VASER Pro Amplifier is provided instead of the VASER Amplifier if the System includes VASERsmooth™ Technology.

** Required if VentX Console is purchased/included. Patent & Trademark Acknowledgements: U.S. Patent Nos. 6,027,515; 6,129,701; 6,368,299; 6,379,326; 6,391,042; 6,540,713; 6,716,194; 6,726,698; D539,417; D548,329 Other U.S. and foreign patents pending. The following are registered trademarks of Solta Medical, Inc.: LipoHarvester, Sound Surgical, LipoSelection, Science to Surgery, VASER, VASERlipo, VASER Hi Def, VentX, PowerX, TouchView, The Tool Behind the Talent, and VASER it. Manufactured by: Solta Medical, Inc. 11720 North Creek Parkway North, Suite 100 Bothell, WA 98011 USA For Customer Support call: 877-782-2286 (outside the U.S./Canada 1-510-259-5299) For Technical Support call: 877-782-2286 (outside the U.S./Canada 1-510-259-5299) © 2018 Solta Medical, Inc. (all rights reserved) Made in USA Printed in USA Follow local governing ordinances and recycling plans regarding the recycling or disposal of this equipment and its accessories.

Your local representative or authorized distributor: European Authorized Representative

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Medical Device Safety Service Schiffgraben 41 30175 Hanover, Germany

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Table of Contents Preface and Introduction... 1 1.0

Patient and Operating Room Safety... 1 Warnings, Cautions, Notices, and Symbols... 1 Contraindications... 7 Operator Warnings... 7 Operator Cautions... 8 Indications for Use... 9 Alert/Warning Conditions... 9

2.0 Equipment Description... 10 Equipment List... 10 Using the VASER or VASER Pro Amplifier with the VentX Console... 12 3.0 Using the VASER Amplifier... 12 Before Surgery... 12 During Surgery... 12 After Surgery... 12 4.0 Using the VASER® Pro Amplifier... 13 Before Surgery... 13 During Surgery... 13 After Surgery... 13 5.0 Cleaning... 14 6.0 Troubleshooting... 15 VASER Test Switch... 15 7.0 Maintenance... 17 8.0 Specifications and Standards... 18 Technical Specifications... 18 Voluntary Standards... 25

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9.0 Installation, Returns, and Warranty... 26 Unpacking and Assembling the VASER or VASER Pro Amplifier... 26 Unpacking and Inspection... 26 Assembly of the Equipment... 27 Servicing the VASER and VASER Pro Amplifier... 27 Return Material Authorization (RMA)... 27 Limited Warranty... 27 Exclusion of Other Warranties... 27

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Preface and Introduction Solta Medical thanks you for your recent purchase of the VASER® or VASER Pro Amplifier. The VASER and VASER Pro Amplifiers create ultrasonic frequency vibration in a VASER Probe that is used to cause a surgical effect. The ultrasonic frequency vibration is created using the piezoelectric property of PZT ceramic crystals located in the VASER Handpiece. The PZT ceramic crystals expand and contract in cooperation with electrical power supplied to the VASER Handpiece by the Amplifier. The VASER and VASER Pro Amplifiers are electronic control systems that maintain vibration amplitude, maintain proper vibration frequency, and provide two modes of vibration, continuous and VASER (pulsed). The VASERlipo™ System includes the VASER Amplifier (or VASER Pro Amplifier), and the VentX® Infiltration and Aspiration Console.

1.0

Patient and Operating Room Safety

Warnings, Cautions, Notices, and Symbols Warning: Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury. Caution:

Indicates a potentially hazardous situation that, if not avoided, could result in minor or moderate injury.

Notice:

Indicates a potential hazard that may result in product damage.

BS EN ISO 15223-1: 2016 Medical devices-Symbols to be used with medical device labels, labeling and information to be supplied. Part 1: General requirements Symbol

Symbol Ref. No.

Symbol Title

5.1.1

Manufacturer

5.1.2

Authorized representative in the European Community

5.1.3

Date of manufacture

Additional Information The date of manufacture, as well as the name and address of the manufacturer, can be combined in one symbol. Additional reference ISO 7000-3082.

This symbol can be filled or unfilled. If filled, the date of manufacture as well as the name and address of the manufacturer can be combined in one symbol. Additional reference ISO 7000-2497.

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BS EN ISO 15223-1: 2016 Medical devices-Symbols to be used with medical device labels, labeling and information to be supplied. Part 1: General requirements Symbol

Symbol Ref. No.

Symbol Title

Additional Information

5.1.5

Batch code

Synonyms for “batch code” are “lot number” and “batch number.” Additional reference ISO 7000-2492.

5.1.6

Catalogue number

Synonyms for “catalogue number” are “reference number” and “reorder number.” Additional reference ISO 7000-2493.

5.1.7

Serial number

Additional reference ISO 7000-2498.

5.3.1

Fragile, handle with care

Additional reference ISO 7000-0621.

5.3.4

Keep dry

Additional reference ISO 7000-0626.

5.3.7

Temperature limit

Additional reference ISO 7000-0632.

5.3.8

Humidity limitation

Additional reference ISO 7000-2620.

5.3.9

Atmospheric pressure limitation

Additional reference ISO 7000-2621.

5.4.3

Consult instructions for use

Synonym for “Consult instructions for use” is “Consult operating instructions.” Additional reference ISO 7000-1641.

IEC TR 60878 Ed. 3.0 b:2015 Graphical symbols for electrical equipment in medical practice Symbol

Symbol Ref. No.

5007

Symbol Title

“ON” (power)

Additional Information To indicate connection to the mains, at least for mains switches, or their positions, and all those cases where safety is involved. Additional reference IEC 60417-5007 (2002-10).

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IEC TR 60878 Ed. 3.0 b:2015 Graphical symbols for electrical equipment in medical practice Symbol

Symbol Ref. No.

5008

Symbol Title

“OFF” (power)

Additional Information To indicate disconnection from the mains, at least for main switches, or their positions, and all those cases where safety is involved. Additional reference IEC 60417-5008 (2002-10). To identify fuse (fuse boxes) or their location

5016

Fuse

Additional reference IEC 60417-5016 (2002-10).

Protective earth; protective ground

To identify any terminal that is intended for connection to an external conductor for protection against electric shock in case of fault, or the terminal of a protective earth (ground) electrode. Additional reference IEC 60417-5019 (2006-08).

Equipotentiality

To identify the terminals which, when connected together, bring the various parts of an equipment or of a system to the same potential, not necessarily being the earth (ground) potential, e.g. for local bonding. Additional reference IEC 60417-5021 (2002-10).

5032

Alternating current

To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals. Additional reference IEC 60417-5032 (2002-10).

5114

Foot switch

To identify a foot switch or the connection for a foot switch. Additional reference IEC 60417-5114 (2002-10)

5132

Programmable start or timer

5019

5021

Timer Display To identify a display of the programmed or to-be-programmed start time.

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IEC TR 60878 Ed. 3.0 b:2015 Graphical symbols for electrical equipment in medical practice Symbol

Symbol Ref. No.

5334

Symbol Title

Type BF applied part

Additional Information To identify a type BF part complying with IEC 60601-1. Additional reference IEC 60417-5334 (2002-10)

Note 1 – B = Body. Note 2 – F = Floating applied part. 5448

Input/output

Ultrasound footswitch control. To identify a combined input/output connector or mode. Power Plug: auxiliary outlet IEC 320 Sockets.

5534

Power Plug

To identify connection means (e.g. plug or cord) to the power source (mains) or to identify the storage place for the connecting means. Test Mode Switch

5659

Start, test run

5713

To identify the control or the indicator to Variation of ultrasound increase or decrease the emitted ultrasound energy energy, typically in conjunction with footswitch control. Amplitude Control

ISO 7000-2164

Variability, in amplitude, variability in steps

5777

Electrode Handle

To indicate a reference to an electrode handle, e.g. storage, use, connector.

Stacking limit

To indicate that the items shall not be vertically stacked, either because of the nature of the transport packaging or because of the nature of the items themselves.

ISO 7000-2402 (2011-06)

ISO 7000-2794 (2011-06)

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To identify the control or the indicator for starting a test run.

Packaging unit

-T  he controlled quantity increases in steps with clockwise rotation.

To indicate the number of pieces in the package. Additional reference ISO 7000-2794 (2009-02)

Note – A number is inserted in the symbol to indicate the number of parts in the package.

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IEC TR 60878 Ed. 3.0 b:2015 Graphical symbols for electrical equipment in medical practice Symbol

Symbol Ref. No.

Symbol Title

Additional Information To signify a general warning.

Note - This safety sign cannot be used on its own and requires a supplementary sign to give further information about the hazard.

ISO 7010-W001 (2011-06)

General warning sign

ISO 7010-W005 (2011-06)

Warning: Non-ionizing radiation

To warn of non-ionizing radiation.

ISO 7010-W012 (2011-06)

Warning: electricity

To warn of electricity.

IEC TR 60878 note: On medical equipment, this safety sign shall only be used if there is no other safety sign for the corresponding hazard. If possible, the hazard or the appropriate precaution should be indicated.

BS EN 50419:2006 Marking of electrical and electronic equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE) Symbol

Symbol Title

WEEE wheeled bin

Additional Information This product contains electrical and electronic components that may contain materials which, if disposed with general waste, could be damaging to the environment. Residents of the European Union must follow specific disposal or recycling instructions for this product. Residents outside the European Union must dispose or recycle this product in accordance with local laws or regulations that apply.

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Other Marks and Symbols Symbol

Symbol Description Ultrasound Footswitch Connection

Based on IEC 60878-5117 and 5713

Foot pedal interconnect for Ultrasound footswitch

Based on IEC 60878-5117, 5713, and 5448

Ultrasound Probe

Electrosurgery Handpiece, Based on IEC 60878-5777 and 5713

VASERsmooth™ Technology Label

Indicates VASER Pro Amplifier includes VASERsmooth Technology

Universal Recycling Symbol U+2672

Recycling Symbol followed by the number or description of the recyclable material to indicate that the marked item or its material is part of a recovery or recycling process.

For U.S. Only: Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician or licensed health care professional.

USA Code of Federal Regulations 21 CFR Part 801 § 801.109(b)(1)

European Conformity mark Notified Bodies: DEKRA (0344) TUV Rheinland (0197)

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Additional Information

The product conforms to European Medical Directive 93/42/EEC and meets applicable health, safety and environmental requirements. If the mark is accompanied by a number, conformity is verified by the indicated notified body.

ETL Product Listing mark

Represents compliance to North American product safety standards as determined through independent testing and certification by Intertek Group plc.

MADE IN USA

Country of origin symbol

T h e VA S E R l i p o ™ S y s t e m

Solta Medical has determined that the VASER/VASERlipo System has been shown to comply with the applicable technical standards if no unauthorized change is made in the equipment and if the equipment is properly maintained and operated. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

Contraindications Use of this device is contraindicated for patients with chronic medical conditions, such as obesity, diabetes, blood clotting disorders, heart, lung, or circulatory system disease, or vascular problems, including common circulation problems and coagulation problems associated with certain medications. The following conditions may affect the safety or effectiveness of this device: presence of collagen, scarring, or connective tissue disorders; presence of stretch marks or potential for stretch mark formation; Lupus Erythematosus; endocrine disorders; pregnancy or the possibility of pregnancy; or other active diseases that may affect the procedure outcome or increase risk.

Operator Warnings Warning: No modification of the equipment is allowed. Warning: This device will not, in and of itself, produce significant weight reduction. Warning: T  he 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: The VASER/VASERlipo System is intended for use by healthcare professionals only. Warning: T  he VASER/VASERlipo System may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the VASER/VASERlipo System or shielding the location. Warning: It is essential the VASER/VASERlipo System performs per the operators input settings. Placing the system in areas where intense electromagnetic disturbances could be present may affect the input settings and could possibility result in patient harm. Warning: The use of accessories, transducers and cables other than those specified or provided Solta could result in increased electromagnetic emissions or decreased electromagnetic immunity of the VASER/VASERlipo System and result in improper operation. Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the VASER/VASERlipo System, including cables specified by Solta. Otherwise, degradation of the performance of this equipment could result.

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Warning: The VASER/VASERlipo System should not be used adjacent to or stacked with other (non-Solta Medical) equipment. If adjacent or stacked use is necessary, the VASER/VASERlipo System should be observed to verify normal operation in the configuration in which it will be used. As part of normal operation, the following Solta Systems can be used at the same time in a stacking configuration. The VASER Pro Amplifier System, the VentX System, and the PowerX System have been tested in a stacking configuration and comply with the applicable emissions and immunity requirements specified in IEC 60601-1-2:2014. Warning: Do not block or cover the ventilation openings on the VASER/VASERlipo System. Overheating could occur, causing decreased functionality of the system. Warning: To avoid risk of electric shock, this equipment must be connected to a supply mains with protective earth.

Operator Cautions Caution:

 he safe and effective use of this medical device depends to a large degree on factors solely T under the control of the operator. It is important that all operators of this surgical system read, understand, and follow the operating instructions supplied with this equipment.

Caution:

U.S. Federal Law restricts this device to sale to or on the order of a physician.

Caution:

 he VASER/VASERlipo System is intended to be used in a Professional healthcare facility T environment (e.g.; hospitals or outpatient clinical surgical facility). It does not include areas where there are sources of intense electromagnetic disturbances, such as a RF shielded room of magnetic resonance imaging, or in operating rooms near active HF surgical equipment.

Caution:

 his device is designed to contour the body by removing localized deposits of excess fat through T small incisions.

Caution:

If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation.

Caution:

 se of this device is limited to those physicians who, by means of formal professional training U or sanctioned continuing medical education (including supervised operative experience), have attained proficiency in suction lipoplasty.

Caution:

 esults of this procedure will vary depending upon patient age, surgical site, and experience of the R physician.

Caution:

 he amount of fat removed should be limited to that necessary to achieve a desired cosmetic T effect.

Caution: All reusable components of the device must be sterilized and all disposable components replaced before using the device on another patient. Note: The Emission characteristics of this equipment make is suitable for the use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential/domestic environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

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Indications for Use The VASER Amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy). The VASERlipo System is intended for the fragmentation, emulsification and aspiration of subcutaneous fatty tissue for aesthetic body contouring (modification of the anatomy). The VASERlipo System is also indicated for use in the following surgical specialties for the fragmentation, emulsification and aspiration of soft tissues: √ Neurosurgery

√

Orthopedic Surgery

√ Gastrointestinal and Affiliated Organ Surgery

√

Gynecologic Surgery

√ Urologic Surgery

√

Thoracic Surgery

√ Plastic and Reconstructive Surgery

√

Laparoscopic Surgery

√ General Surgery

Alert/Warning Conditions The VASER and VASER Pro Amplifiers are equipped with audible and visual indicators (Alert/Warning) for a fault condition. The audible Alert/Warning signal indicator is an urgent Alert/Warning tone. Two conditions exist whereby an audible Alert/Warning signal indicator will occur: 1.

When the VASERsmooth™ Handpiece is connected to the VASER Pro Amplifier. The System will sound with 4 audible tones to indicate that the System detects the Handpiece (VASER Pro Amplifier only). Please reference the VASERsmooth Procedure Suggestions (240 0432) for additional information on using the VASERsmooth Handpiece and Probes with the VASER Pro Amplifier.

2. For a fault condition in which the visual indicator (a red ‘ will be triggered if:

’) will also be displayed. The fault indicators

a) T  he Footswitch has been depressed and ultrasonic vibration has not been initiated within about one second. See Troubleshooting Section. b) Ultrasonic vibration has been initiated and a stall condition is encountered lasting longer than about one second. See Troubleshooting Section. c) Excessive VASER Probe loading is encountered. The VASER Amplifier senses the loading present on the vibrating probe. If the VASER Probe loading is excessive, as might occur with overly fibrous tissue for a selected VASER Probe or from ‘torquing’ of the VASER Handpiece, an Alert/Warning will sound. If there is a failure of the equipment, such as a faulty or disconnected Handpiece, an Alert/Warning will sound. See Troubleshooting Section for more details.

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2.0 Equipment Description Equipment List The VASER and VASER Pro Amplifiers are composed of the following main components to include multiple controls, indicators and receptacles.

Figure 1. Front View

7.

4.

8.

9.

1. 2.

1.

Amplitude Control

3.

5.

6.

6. Timer Reset Button

2. Amplitude Display

7. Ultrasound Vibration Time Indicator

3. VASER (V) Mode Indicator

8. Ultrasound Vibration Active Indicator -

4. Mode Selection Button*

9. Alert/Warning Signal Indicator -

5. Continuous (C) Mode Indicator

* Press and hold to put Amplifier in Standby Mode

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Figure 2. Rear View

2.

1. 3.

1.

VASER Footswitch Receptacle

2. AC Power I/O Switch 3. Power Entry Module

Figure 3. Right Side View

1.

1.

2.

VASER Handpiece Receptacle

2. VASER Test Switch

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Using the VASER or VASER Pro Amplifier with the VentX Console The VASER or VASER Pro Amplifier may be combined with the VentX Console. See the VentX Console and Accessories User’s Guide for connection instructions.

3.0 Using the VASER Amplifier This section describes the day of surgery set-up and use of the VASER Amplifier.

Before Surgery 1.

Connect VASER Amplifier to a source of AC power.

2. Ensure the VASER Footswitch cord is connected to the Amplifier. 3. Turn on the VASER Amplifier. (the ‘C’ and ‘V’ Mode Indicators should be flashing/in Standby Mode) 4. Test VASER Amplifier with the VASER Test Switch. (See Troubleshooting Section for details.) 5. In the sterile field pass the connector of the VASER Handpiece out of the sterile field and connect the VASER Handpiece to the VASER Handpiece Receptacle on the VASER Amplifier.

During Surgery Caution: Notice: 1.

Do not lay the VASER Handpiece on the patient when not in use. Do not activate ultrasonic vibration with the VASER Probe in free air. Probe damage is likely to occur.

Select mode of operation using the Mode Selection Button (C or V).

2. Adjust the vibration amplitude using the Amplitude Control on the VASER Amplifier. 3. Activate ultrasonic vibration by depressing the VASER Footswitch. 4. Reset VASER Timer using Timer Reset Button as needed. 5. In the sterile field, attach and detach different VASER Probes as needed.

After Surgery 1.

Turn off the power on the VASER Amplifier.

2. Disconnect the VASER Handpiece from the VASER Amplifier and set aside for cleaning. 3. Wipe down the VASER Amplifier and Footswitches.

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4.0 Using the VASER® Pro Amplifier This section describes the day of surgery set-up and use of the VASER Pro Amplifier.

Before Surgery 1.

Connect VASER Pro Amplifier to a source of AC power.

2. Ensure the VASER Footswitch cord is connected to the Amplifier. 3. Turn on the VASER Pro Amplifier. (the ‘C’ and ‘V’ Mode Indicators should be flashing/in Standby Mode) 4. Test VASER Pro Amplifier with the VASER Test Switch. (See Troubleshooting Section for details.) 5. In the sterile field pass the connector of the VASER Handpiece or VASERsmooth Handpiece out of the sterile field and connect the Handpiece to the VASER Handpiece Receptacle on the VASER Pro Amplifier. When you connect the VASERsmooth Handpiece to the VASER Pro Amplifier, the System will sound with 4 audible tones to indicate that the System detects the VASERsmooth Handpiece. The System will not sound any audible tones when you connect the VASER Handpiece.

During Surgery Caution: Notice: 1.

Do not lay the VASER Handpiece or VASERsmooth Handpiece on the patient when not in use. Do not activate ultrasonic vibration with the VASER Probe or VASERsmooth Probe in free air. Probe damage is likely to occur.

Select mode of operation using the Mode Selection Button (C or V).

2. Adjust the vibration amplitude using the Amplitude Control on the VASER Pro Amplifier. 3. Activate ultrasonic vibration by depressing the VASER Footswitch. 4. Reset VASER Timer using Timer Reset Button as needed. 5. In the sterile field, attach and detach different VASER Probes or VASERsmooth Probes as needed. Please reference the VASERsmooth Procedure Suggestions provided as part of your User Guide CD for additional information on using the VASERsmooth Handpiece and Probes with the VASER Pro Amplifier.

After Surgery 1.

Turn off the power on the VASER Pro Amplifier.

2. Disconnect the VASER Handpiece or VASERsmooth Handpiece from the VASER Pro Amplifier and set aside for cleaning. 3. Wipe down the VASER Pro Amplifier and Footswitches.

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5.0 Cleaning This section describes cleaning procedures that must be used to assure a clean system. Follow the cleaning procedures and guidelines recommended by your institution. The following are guidelines that may be used in conjunction with your institution’s procedures and guidelines or if no such procedures and guidelines are in place. Shut down all power switches, and disconnect from the main power source to prevent electrical shock. Wipe down the VASER Amplifier and Footswitch using a damp cloth after each use. Notice:

Do not use chlorinated cleaning agents (bleach).

Notice:

Do not use abrasive cleaning agents. Do not apply or spray liquid or liquid cleaning agents onto any receptacles or into any cooling vents.

Notice:

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6.0 Troubleshooting This section describes conditions or malfunctions that may occur before or during the normal course of surgery. Malfunctions usually can be corrected by referring to the table below. If the malfunction cannot be resolved using the table below, discontinue use of the VASER Amplifier and Accessories until the malfunction has been resolved.

For Technical Support call: 877-782-2286 (outside the U.S./Canada 1-510-259-5299)

VASER Test Switch The VASER Test Switch is located on the right panel (between the Handpiece receptacle and the speaker switch). The purpose of the VASER Test Switch is to test the VASER or VASER Pro Amplifier without connection to the VASER Handpiece. If the system does not function, this switch will allow the user to determine if the fault is in the VASER Amplifier or in the Handpiece. The VASER or VASER Pro Amplifier should be tested before each use. To use the VASER Test Switch: 1.

Connect the VASER or VASER Pro Amplifier to a source of AC power.

2. Turn on the VASER or VASER Pro Amplifier. 3. Disconnect the VASER Handpiece from the VASER or VASER Pro Amplifier. 4. Set the Amplitude Control to 10%. 5. Set the Mode Selection Button to continuous (C). 6. Depress and hold the Test Switch for at least three (3) seconds. 7. The yellow vibration and Alert/Warning signal indicators on the front panel should illuminate and the Alert/Warning tone should sound. Proceed to the second part of the test (Step 8, below). If the indicators do not illuminate or the Alert/Warning does not sound, call Technical Support. 8. C  hange the Amplitude Control to 30% and repeat step 6. No indicators or Alert/Warning sound should occur. If indicators illuminate or the Alert/Warning sounds, call Technical Support. 9. Reset the amplitude to appropriate level for surgery.

Troubleshooting Condition

Possible Causes

Amplifier does not operate No power to unit (no ultrasonic vibration transmitted), front panel display is off

Recommended Action 1. Ensure VentX Console is connected to AC source (wall). If VentX Console is not included, ensure Amplifier is connected to AC source (wall). 2. Cycle Amplifier I/O Switch. 3. Check AC Power Cord connections (both ends). 4. Check wall power outlet. 5. Check fuses.

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Troubleshooting Condition

Possible Causes

Recommended Action

Amplifier does not operate Footswitch does not function (no ultrasonic vibration transmitted), front panel display is on

1.

Check VASER Footswitch connection (both ends).

2.

Ensure the VASER Footswitch is being continuously depressed.

Alert/Warning Signal Indicator is on when Footswitch is depressed

Improper VASER Handpiece connection

 heck VASER Handpiece connection to C Amplifier.

Defective VASER Probe

Change VASER probe.

Inoperative VASER Handpiece Change VASER Handpiece. Excessive load or torque

1.

 isengage VASER Probe from heavy D contact with tissue. Re-engage and activate Probe to check for continuing problem.

2. Select a VASER Probe that is appropriate for the type of tissue.

Ultrasound vibration is inadequate

VASER Amplifier malfunction

Use VASER Test Switch. If VASER Test fails, call technical support.

Inappropriate VASER Probe choice

 elect a VASER Probe that is appropriate S for the type of tissue.

VASER Probe is misaligned or C  heck VASER Probe connection to VASER loose Handpiece interface for looseness or misalignment.

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VASER Probe is worn

Change VASER Probe.

VASER Handpiece is worn

Change VASER Handpiece.

Inappropriate Amplitude setting

Adjust Amplitude.