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Vevazz LED

Body Contouring System

Operation Manual

Vevazz, LLC

3839 McKinney Ave. #251

Dallas, TX 75204

Phone: (773) 665-4005

Fax: (888) 234-2765

URL: www.vevazz.com

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Warranty & Service Information

Proprietary Notice

Information contained in this document is copyrighted by Vevazz, LLC and may not be duplicated in full or part by any person without prior written approval of Vevazz, LLC. Its purpose is to provide the operator with adequately detailed documentation to efficiently install, operate and maintain the device supplied. Efforts have been made to keep the information contained in this document current and accurate as of the date of publication or revision.

Limited Warranty

Vevazz, LLC warrants the Vevazz to be free from defects in workmanship and material under normal use for a period of one (1) year from the date of shipment. Vevazz, LLC's sole obligation under this warranty will be to repair or replace, at its option, the Vevazz that proves to be defective during the warranty period. The foregoing shall be the sole warranty remedy. Except as set forth herein, Vevazz, LLC makes no warranties, either expressed or implied, including the implied warranties of merchantability and fitness for a particular purpose. No warranty is provided if the Vevazz is modified without the express written consent of Vevazz, LLC. Vevazz, LLC shall not be liable in any event for incidental consequential damage. This warranty is not activated before the customer returns the completed Vevazz Product Registration form within 30 days after purchase of the product. This warranty is not assignable.

Service Support

In order to return your Vevazz under the terms of this one year limited warranty, you must contact us for a return merchandise authorization number (RMA number) within one (1) year from the shipping date. Call us at 773-665-4005 Monday through Friday 8:00am to 5:00pm MST to obtain the RMA number from our customer service department. The return of the Vevazz and all accompanying documents must be packed carefully to prevent shipping damage. The RMA number must be clearly printed on the outside of the shipping container.

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Warnings, Cautions & Notes

KEYWORD DEFINITION

WARNING Tells you something that could hurt the patient or hurt the operator

CAUTION Tells you something that could damage the device

NOTE Tells you other important information

Symbol Definitions

On the Vevazz Base

SYMBOL DEFINITION SYMBOL DEFINITION

Start control to begin a treatment cycle

Cancel control to cancel out of a menu option

Stop control to stop a treatment cycle

Arrow Up, Arrow Down, Arrow Left and Arrow Right controls to manipulate menu screens and input requested information

Enter control to enter into next menu input

Plug - Insert Power Cord Here O - Power Off Position I - Power On Position

Menu control to view menu options

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On the Vevazz Label (located on the bottom of the Vevazz Base)

Warning! The operator must be thoroughly familiar with the information in this manual before using the device.

Warning! Due to the use of LED technology and the ease of use of the system, NO PRE-QUALIFICATION or TRAINING is required to

operate the device. Prior to use, thoroughly review all information contained in this manual.

Warning! The Vevazz device should be protected from unauthorized use and only operated by those familiar with all information

contained in this manual

Warning! Not intended for ocular applications or direct eye exposure. To avoid optical radiation, protective eye wear, such as glasses

with a shaded UV and UVA protected lens, for both Operator and Patient, while not required, may be worn during operation of the Vevazz.

Warning! Use carefully. May cause serious burns.

Warning! To avoid electrical shock, do not open the base. Qualified personnel only.

Warning! Opening Voids Warranty.

Warning! Not for use on open wounds or sores, minors, people with: pace maker, photosensitivity, epilepsy, any form of cancer, severe

kidney problems, severe liver problems, thyroid problems, or women who are pregnant or nursing. See Situational Warnings section for more detailed information.

Warning! The unattended use of the Vevazz by children or incapacitated persons may be dangerous.

Warning! To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

Warning! Place the Vevazz Base in such a position that the Power Switch can be easily accessed and safely powered off.

Caution! Do not autoclave or immerse light source in liquid.

Note! The Vevazz is a Class 1 LED Device, which is safe under reasonably foreseeable conditions (per IEC 60825-

1:1993+A1:1997+A2:2001).

Note! This equipment is suitable for use in medical offices or households.

Note! In every case it is recommended to keep the equipment away from disturbance sources including fields in order to avoid any

possible instability and malfunctioning of the equipment.

Note! Operation of this device may be adversely affected if used in areas where high moisture or precipitation is present.

Note! There are no customer serviceable parts in this device. If service is required please contact Vevazz, LLC.

Note! Applied Part indicates a part that will be applied directly to the skin.

Note! Protective Apparel is not required for either Operator or Patient. All Paddles {Applied Part} can be placed directly on skin.

Note! The Vevazz has gone through rigorous Electric and Electromagnetic testing and complies with the limits of the standard in

60601.

SYMBOL DEFINITION

Keep Dry. Always keep the Vevazz Base and Paddles dry, store in a cool dry place.

Draft Only - Vevazz is an SGS certified product for US and Canada.

Large and Small Paddles are Applied Parts. All Applied Parts are of Type B as defined in publication 60601-1

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Introduction

About the Manual

The Operation Manual provides operation and maintenance instructions for the use of the Vevazz.

Intended Use and Clinical Effects

The Vevazz is an over the counter device that emits energy in the red spectrum and is to be used for the non-invasive temporary reduction in circumference of waist, thighs, arms and hips by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.

Theory of Operation

The Vevazz is used for applying therapy for the temporary reduction in circumferences by emitting energy via an

electric light emitting diode energy source. Each LED produces 50 mw/cm2 of near infrared light energy with a

wavelength of 650 nm; +/- 25 nm uniformly over the treatment area without producing hot spots. Maximum temperature of

the Applied Parts (Paddles) that can be achieved during normal use is 38⁰ C or 100⁰ F. As skin temperature is raised

during each treatment, the targeted skin temperature range is 39⁰ - 45⁰ C or 102.2⁰ - 113⁰ F. These light delivery systems

are manufactured by Vevazz, LLC. These devices are solid state and held in position with use of Velcro bands for

placement directly on the skin where the treatment is to occur. Not intended for ocular applications or direct eye exposure.

To avoid optical radiation, protective eye wear, such as glasses with a shaded UV and UVA protected lens, for both

Operator and Patient, while not required, may be worn during operation of the Vevazz.

1. Self contained Vevazz system includes associated electronic control and monitoring of all salient operational parameters.

2. High Energy non-thermal, wavelength specific solid state Illuminating paddles run cool to the touch.

3. System control is conveniently located on the top panel of the base unit for ease of operation.

4. Recommended treatment is one Timed Light Delivery cycle, 7 minutes in duration, directly to the treatment area, applied once every 48 hours.

Unpacking and Inspection

Open the carton and check each item in the box. Make sure all components listed below in the Packing List are present in the quantity indicated.

Packing List: Quantity:

1. Vevazz Base Unit (1)

2. Power Cord (1)

3. Large Paddles {Applied Part} (qty determined

by package purchased = Set of 4, 8 or 16 (4), (8) or (16)

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4. Tape Measures (3)

5. Clips (3)

6. Vevazz Velcro Body Straps (6)

7. Velcro Patches (matching quantity

to number of Paddles) (4), (8) or (16)

8. Velcro Cord Straps (matching quantity

to number of Paddles) (4), (8) or (16)

9. Operation Manual (1)

Assembly, Controls and Features

Assembly Instructions

1. Unpack the packages your Vevazz arrived in. Inventory all equipment and compare it to the Packing List listed above, ensuring you have each piece in the quantity referenced.

2. Begin with the Vevazz Base Unit. Inspect for any defects during shipping. Note: Informative label is to be found on the bottom of the Vevazz Base Unit. Please observe this label and all listed indications.

3. Locate the Power Cord.

4. Plug the Power Cord into the Power Port located on the back of the Vevazz Base Unit. Be sure to always have the Vevazz Base positioned so that the Power Switch can be easily accessed and the unit safely powered off.

5. Plug the other end of the Power Cord into a Power Source such as a Surge Protector or the Wall Outlet. Note: It is suggested that a Surge Protector be used to prevent any power surges. The cord can be plugged directly into a Wall Outlet, though the use of a Surge Protector is highly recommended.

6. Turn on the Vevazz Base Unit by flipping the Power Switch to the On Position.

7. The Vevazz Base Unit should now be powered on as indicated by the information displayed on the LCD Screen.

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8. Locate the Large Paddles {Applied Part}, number will vary based on the package purchased, either 4, 8 or 16 in quantity.

9. Plug the Large Paddles into any of the 16 Ports, all black in color, on the back of the Vevazz Base Unit.

10. Once steps 1 through 9 are complete, the Vevazz Base Unit should look as follows. (Note: the illustration is for a 4 Large Paddle setup.)

11. The Vevazz is now ready for use. Please review the Operating Instructions below for information on the proper placement of the Large Paddles. Once the paddles are placed on the patient, proceed to #12 below.

12. Press the Start Button to begin a 7 minute treatment cycle. Note! There is NO Risk to making misconnections however any misconnection made by plugging Paddles into incorrect Ports will prevent the operation of the Paddles.

Vevazz Controls

Pressing the Start button will initiate the LED light delivery treatment cycle. This light delivery treatment cycle will terminate automatically when the timed light delivery treatment cycle is complete.

Pressing the Stop button will stop the light delivery treatment cycle

Pressing the Menu button will allow access to the menu selection screens.

Pressing the Enter button will advance to the next screen or menu option within the menu selection screens.

Pressing the Cancel button will cancel out of a selection within the menu selection screens.

Pressing the Arrow Up, Arrow Down, Arrow Left and Arrow Right buttons will advance between menu selection screens and allow the input of requested information within the menu selection screens.

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Operating Instructions

Prior to use, the Vevazz device should be protected from unauthorized use and only operated by those familiar with all information contained in this manual.

1. Assemble the Vevazz Base Unit, including the Large Paddles {Applied Part} as illustrated in the Assembly Instructions. Plug in the number of Large Paddles to be used.

2. Large Paddle Placement - Place each Large Paddle on the body below the neck, directly over the area needing to be

treated. (See diagram below for areas of placement). Suggested areas of placement are the waist, thigh, arm and hip regions (marked in diagram below in Green). Paddles can also be placed in other regions of the body needing treatment (marked in diagram below in Red). The diagram is an approximation of Paddle placement. Use the Velcro Patches as needed, to be put in place on the back of each Large Paddle using the adhesive, and the Vevazz Velcro Body Straps as needed in order to hold the Paddles in place.

Large Paddle Placement:

Place Large Paddles in the areas marked Green to treat the waist, thighs, arms and hips

Place Large Paddles in the areas marked Red to treat other regions

3. Press the Start Button to initiate the LED light delivery treatment cycle. The treatment cycle will terminate once the 7 minute timer has elapsed.

4. How to Stop A Treatment Cycle: Pressing the Stop Button during the treatment cycle will stop the treatment and reset the machine back to the Initial Screen Display. This puts the Vevazz in an entirely safe condition. To begin a new treatment cycle, press the Start Button once again.

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Screen Displays and Menus

Initial Screen Display each time the Vevazz Base Unit is powered on. Press the Start Button to begin the LED light delivery treatment cycle. During the treatment cycle the 7:00 minute time will count down to 0:00 and then will terminate the treatment cycle.

Main Menu: 1. Used Time Screen Display when the Menu Button is pressed. The Up Arrow can be used to advance to the next menu selection screen.

Used Time: Screen Display when the Enter Button is pressed while in the: 1. Used Time menu selection screen. The information displayed is the TOTAL amount of time the Vevazz Base Unit has been used to deliver all previous LED light delivery treatment cycles.

Main Menu: 2. Remaining Time Screen Display when the Down Arrow Button is pressed once. The Up or Down Arrows can be used to advance or return to the next or previous menu selection screen.

Remaining Time: Screen Display when the Enter Button is pressed while in the: 2. Remaining Time menu selection screen. The information displayed is the REMAINING amount of time the Vevazz Base Unit has to deliver all future LED light delivery treatment cycles prior to needing an Hours Code to increase the Reaming Time. Hours codes can be obtained by contacting Vevazz, LLC. Hours Codes, once entered will increase the Remaining Time by 50 hour increments.

Main Menu: 3. Enter Password Screen Display when the Down Arrow Button is pressed twice. The Up or Down Arrows can be used to advance or return to the next or previous menu selection screen.

Enter Password: This screen is used to enter an Hours Code Screen Display when the Enter Button is pressed while in the: 3. Enter Password menu selection screen. The Up and Down Arrows are used to enter digits 0-9. The Right Arrow is pressed to advance to the next digit to be entered. Once the last digit of the Password is input, press the Enter Button to enter the Password for the Hours Code, provided from Vevazz, LLC. Once entered, remaining time will be increased by 50 hour increments.

Main Menu: 4. Change Run Time Screen Display when the Down Arrow Button is pressed three times. The Down Arrow can be used to return to the previous menu selection screen.

Change Run Time: Screen Display when the Enter Button is pressed while in the: 4. Change Run Time menu selection screen. The information displayed is the Current amount of time each LED light delivery treatment cycle will run. Pressing the Up or Down Buttons will increase or decrease the treatment cycle run time. Suggested run time for each LED light delivery treatment cycle is 7 minutes.

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Situational Warnings

Below is a list of situational warnings - situations in which the Vevazz SHOULD NOT be used to deliver an LED light delivery treatment cycle. Situational warnings are conditions or factors that serve as a reason to withhold treatment because it may be harmful to the patient. If at any time there is a question as to whether a treatment should be administered using the Vevazz, always consult a medical doctor first.

Not for use on:

Open wounds or sores

Minors

People with a pacemaker

People who have or are affected by photosensitivity

People with epilepsy

People with any form of cancer

People with severe kidney problems

People with severe liver problems

People with thyroid problems

Women who are pregnant or nursing

Maintenance

Cleaning and Disinfection

Item: How Often: Procedure:

Large Paddles After each use Using a soft cloth dampened with warm soapy water or isopropyl alcohol, wipe the entire face of the large paddle, including the plastic window of the light-emitting surface. CAUTION: Do not allow liquid to enter any of the openings on the unit.

Vevazz Base Unit As Needed Using a dusting cloth remove dust and any other particles that may have settled on the unit. Wipe LCD screen as needed with same dusting cloth. CAUTION: Do not dampen a cloth to clean the Vevazz Base Unit, always keep dry and store in a cool dry place.

Preventative Inspection

Before each use, carefully inspect the Vevazz Base Unit to make sure it does not appear damaged.

Before operation the operator should also check all Large Paddles to verify that the protective cover housing the LEDs is intact.

Vevazz, LLC has no serviceable or calibration requirements.

At the end of the Vevazz’s Service Life, return the Vevazz Base Unit, any Large Paddles to Vevazz, LLC for proper disposal and recycling. Warning, for safe disposal, do not place electronic equipment in a waste bin or trash can, or left for waste management. Contact Vevazz, LLC to return all electronic equipment for proper disposal and recycling.

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Specifications and Contact Information

Power Requirements

Power:120VAC@4A or 240VAC@2A

Electrical output: 15 VDC @ 8.5 AMPS

Power Input: 50~60 Hz

Fuse Rating: 4 AMPS 250 VOLT

Model Specifications

LED: Class 1 Non-Prescription

Environmental Specifications

Operating Temperature: 10 - 40⁰ C (50 - 104⁰ F)

Min/Max Temperature of Applied Parts: 10 - 38⁰ C (50 - 100⁰ F)

Storage Temperature: -30 - 55⁰ C (-22 - 131⁰ F)

Relative Humidity: 10 - 95% (storage), non-condensing

Atmospheric Pressure: 101.325 kPa +/- 17 kPa

Storage

Whenever possible, the Vevazz should be stored at room temperature in a cool, dry place.

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Contact Information

In the United States or Canada Contact:

Vevazz, LLC

3839 McKinney Ave. #251

Dallas, TX 75204

Tel: (773) 665-4005

Fax: (888) 234-2765

URL: www.vevazz.com