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User Manual
International
Venus VIVA User Manual
Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01

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Summary of Contents for VENUS CONCEPT Venus Viva

  • Page 1 User Manual International Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 2 Copyright 2009 Venus Concept. All rights reserved. Print date: July 2013 Venus Concept Ltd. reserves the right to make changes to its products or specifications to improve performance, reliability, or manufacturability. Information furnished by Venus Concept Ltd. is believed to be accurate and reliable. However, Venus Concept Ltd.
  • Page 3: Table Of Contents

    Glossary of Symbols Used in this Manual ................ 1-1 S/N Label ......................... 1-2 WARNING ........................1-3 Chapter 2 - Introduction ....................2-1 View of Venus Viva System ..................... 2-1 System Description ......................2-2 Chapter 3 - Safety ......................3-1 Introduction ........................3-1 The Operator ........................
  • Page 4 Cleaning the applicators....................7-1 Disinfection the applicators ....................7-2 Cleaning the tip ........................ 7-2 Chapter 8 - Troubleshooting .................... 8-1 Chapter 9 Technical Specifications ................9-1 Chapter 10 Manufacturer Warranty ................10-1 Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 5: Chapter 1 - Before You Start

    Manufacturer. Obelis S.A. Authorized Representative in the European Community. Manufacturer (accompanied by the name and address of the manufacturer). Date of Manufacture. Symbol used with a HF isolated patient circuit. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 6: S/N Label

    Consult Instruction for Use. System that includes RF transmitters or that applies RF electromagnetic energy for diagnosis or treatment. S/N Label Figure 1-1, Venus Viva Serial Number Label Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 7: Warning

    The Venus VIVA is designed for professional use only. The manufacturer cannot be held responsible for damage or injury caused by improper use or for uses other than those for which this machine is intended.
  • Page 8: Chapter 2 - Introduction

    2. Introduction View of Venus Viva System Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 9: System Description

    On/Off Button. k. Power Socket. System Description The Venus VIVA is a non invasive medical aesthetic device for dermatological procedures requiring ablation and resurfacing of the skin. Sublative Rejuvenation with Venus Viva is a unique procedure which uses radio frequency energy to deliver an effective but controlled ablative treatment. The procedure is intended to provide a noticeable ...
  • Page 10  The device is intended to be used by professional practitioners in the medical aesthetic field.  The operator should stand near the client.  The operator is not allowed to leave a client during the entire treatment. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 11: Chapter 3 - Safety

    RF used in this (MP)² technology can cause injury if used improperly.  High voltage is present inside the System, do not attempt to open the  casing.  Disconnect the System from the power supply before servicing (pull out Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 12 Do not tamper with the controls or attempt to open up the System.  Do not abuse, sit or lean on the system.  Venus Viva System should be kept out of the reach of Children.  Do not allow the Applicators to come in contact with metal elements this ...
  • Page 13: Fire Hazards

    Do not use flammable substances when preparing the skin for treatment.  If germicide swipes is used for cleaning and disinfecting the system, it  must be allowed to fully dry before the System can be used again. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 14: Chapter 4 - System Installation

    4. System Installation The system is designed for operation in a clinical environment and it may be easily transported inside a protective carrying case. The Venus VIVA system is set up by doing the following: 1. Unpack the system. 2. Check the integrity of the system and all components.
  • Page 15: Electrical Requirements

    -20 to 55°C (-13 to 131°F) with a relative humidity of 0-90 % @ 55°C non- condensing. For Optimal transportation system should be transport under the temperature range between -10º- 60ºC (14º-140ºF) with a relative humidity of less than 80% and altitude up to 15000m. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 16: Connect The Applicators

    To disconnect the applicator, turn the black ring (B) counter-clockwise (in the direction of the arrow) until it releases and then pull the connector out. Seat the applicator in its cradle (see Figure 4-3). Figure 4-3 Applicators in its cradle Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 17: Connect/Disconnectiong A Tip To Scan Fx Applicator

    – and push it onto the applicator's connection port (A) until you feel it click. To remove the tip from the applicator, press the release button under the tip's connection port (B); the tip will pop off. Figure 4-4 Connected tip to applicator Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 18: Chapter 5 - Operating The System

    It is recommended to change initial Login code, using Set Login Code option in Tools Menu. Once the correct code has been entered, the default Treatment screen will be displayed. Figure 5-1: Login screen Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 19: Treatment Screen

    In order to perform a treatment, operator should follow these steps: 1. Select the desired Applicator according to required treatment mode and area 2. Adjust treatment parameters 3. Initiate treatment Figure 5-2: Default Treatment screen Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 20: Selecting Desired Applicator

    Fractional RF Treatment Mode Figure 5-3 presents the treatment parameters associated with Scan FX applicator. The numbered tags correspond to the following numbered elements of the screen: Figure 5-3: Scan FX Treatment screen Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 21 Once the tip is consumed, a message will be displayed warning that the tip is consumed and needs to be replaced. Tools Button: This button allows the operator to access the Tools screen. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 22 Scan FX applicator. Once this button is pressed, Advanced Treatment screen will be displayed with additional elements as described in Figure 5-4. Figure 5-4: Advanced Treatment screen Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 23 Pulse Amplitude indicator (marked 9B). Pulse amplitude is measured in Volts and adjustment is made in one Volt increments. The graph will display the resultant RF energy output in percent of maximum RF energy output. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 24: Operating The Scan Fx Applicator

    Ready mode, a tip is connected and the trigger is pulled. The applicator is equipped with a light bar that indicates when the applicator is ready to emit a pulse. Pull the trigger (marked A) to emit a pulse. Figure 5-5: Scan FX applicator Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 25: (Mp)2 Treatment Mode

    Figure 5.6 presents the treatment parameters associated with Firm FX and Firm BX applicators. The numbered tags correspond to the following numbered elements of the screen: Figure 5-6: (MP) Treatment screen Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 26 Once the Pause button has been pressed, it will illuminate in red, the system will stop emitting (MP) energy and treatment time countdown will temporarily stop. Pressing the Start button will resume the treatment. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 27: Tools Screen

    7) on any Treatment screen. Tools screen will appear (see Figure 5.7), enabling operator to personalize the system, and allowing a qualified Venus Concept technician to update the system software, calibrate the screen and control various settings. Figure 5.7 presents the Tools screen. The numbered tags correspond to the following...
  • Page 28 (marked 4C). Figure 5-8: Set Volume screen 4. Set Login Code Button: This button allows the operator to change the login code required to access the treatment screen. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01 5-11...
  • Page 29 "+" and "-" buttons adjacent to the padlock icon (marked 7A). Auto Logout Time is defined between 15 minutes 4 hours and adjustment is made in one minute increments. Changes made to the volume Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01 5-12...
  • Page 30 Pressing the System Information button will display a new window (see figure 5-11) showing the system Software version, and the serial number of the device. Pressing the Confirm button (marked 8A) will close the System Information screen. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01 5-13...
  • Page 31 Figure 5-11: System Information screen 8. Technician Mode Button: This button is password protected, to be used by qualified Venus Concept technicians only. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01 5-14...
  • Page 32 To extend the use of the system when it is restricted by date or time, operator should follow these steps: Press the Activation Code button. A new window will be displayed (see Figure 5-12), displaying a 4-character Key number (marked 10A). Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01 5-15...
  • Page 33 Enter the new activation code on the screen and press the Confirm button (marked 10B). Press the abort button (marked 10C) to exit without entering an Activation code. Figure 5-12: Activation Code screen Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01 5-16...
  • Page 34: Chapter 6 - Treatment Procedures

    Fractional RF Treatment Mode Using Scan FX Applicator The Venus Viva system, using the Scan FX applicator, is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. Through an array of small electrodes organized on a tip, Radiofrequency energy is transmitted into the tissue, producing an injury in a certain pattern to the skin.
  • Page 35 Test spots cannot indicate long-term adverse events. In case of uncertainty regarding potential side effects, have the patient consult his/her primary care physician and bring a written consent for treatment. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 36: Possible Side Effects

    Shave any hair in the treatment area.  No lotion, gel or coupling medium should be used during treatment. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 37: Test Treatment

    In addition, it is advisable to perform a test spot whenever changing parameters. Asian patients – after spot testing enforce a "waiting period" for one skin type level higher than apparent skin type. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 38: Treatment Procedure

    Treat the untreated patches of skin as normally.  Fine-tuning of the parameters should be done before proceeding to treatment of the entire facial sub-area with the selected parameters. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 39: Treatment Protocol

    The number of treatment sessions depends on the individual patient and typically varies between 3-4 sessions, every 4-6 weeks. One touch-up session may be needed every ~6 months, according to individual response. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 40: Treatment Parameters

    Make-up may be applied only 12 hours after each treatment if desired, unless an unwanted reaction occurs in the area. Generally 24 hours after treatment, patients may use regular soaps, but not scrub soaps or exfoliants. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 41: Follow-Up

    Treatment should be concluded when the results are satisfactory to the patient or according to the physician's discretion. Generally 3-4 sessions within 4-6 weeks are needed. Do not perform more than five consecutive sessions. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 42: (Mp) 2 Treatment Modality Using Firm Fx And Firm Bx Applicators

     Thyroid gland - not recommended to treat over the thyroid gland.  Ongoing use of Isotretinoin (e.g. Roaccutane).  Recent fillers injection.  Recent surgical procedure/special medications.  Rosacea (applicable to face treatments only). Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 43: Pre-Treatment

    Consistency in photography conditions is imperative and efforts should be made to keep it.  Treatment documents should be kept with patient chart. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01 6-10...
  • Page 44: General Treatment Information

     In the event that the patient experiences discomfort or pain during the treatment, either decrease the energy %, or apply more glycerin, or perform bigger and quicker movements or stop the treatment. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01 6-11...
  • Page 45  Typically, optimal results will be achieved within 6-10 sessions performed once a week. The actual number of sessions needed depends on the initial condition of the patient and their compliance. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01 6-12...
  • Page 46: Chapter 7 - Maintenance

    0.5% ANIOSYME DD1, to clean the applicator until it is visually clean. Use the enzymatic detergent according to manufacturer instructions. 7.1.1.2 Use a soft cloth, moistened with water to remove detergent residuals.  Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 47: Disinfection The Applicators

    If the tip requires cleaning during treatment, ensure that the system is in  Standby mode before cleaning. When finished, reset the system to Ready mode and continue the treatment.  Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 48: Chapter 8 - Troubleshooting

    Pull the fuse drawer out using a flat screwdriver.  system and nothing Remove the two fuses and check if they are burnt.  appears Replace fuses if necessary as shown on figure below.  Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 49 If the new login code New Login Code is not identical in both times - the login code is not Failed - Please Try replaced. Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 50 Try to enter the activation code again  message: If the message still appears, contact your local  "Invalid Activation distributor. Code Please Enter Activation Code" appears on the screen Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 51: Chapter 9 - Technical Specifications

    Max Output Energy 62mJ/pin ( Scan FX applicator) Magnetic Pulse 15Hz. Frequency Magnetic Field Up to 15 Gauss Dimensions W x L x H : 380mmx400mmx280mm Weight 8 Kg Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 52 Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01...
  • Page 53: Chapter 10 - Manufacturer Warranty

    Company. Please fill in your details, scan and e-mail to service@venus-concept.com Business Name: Contact: Address: Telephone Number: Email Address: Date Purchased: S/N: Venus VIVA User Manual Effective Date: 28.07.13 P/N: DCVIROW3 Rev.01 10-1...

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