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

 

 

 

 

(MP)

2

  Treatment  Modality  Using  Firm  FX  and  Firm  BX 

Applicators 

Exclusion Criteria 

 

Active Inflammation and/or Infection on the treatment area. 

 

Current or history of cancer & premalignant condition. 

 

Degenerative neurologic diseases.  

 

Diseases stimulated by heat, (such as recurrent Herpes Simplex in the treatment 

area). 

 

Internal defibrillator/pacemaker. 

 

Metal implants in the treatment area, excluding dental implants.  

 

Uncontrolled disorder of the Thyroid gland. 

 

Varicose veins. 

 

Pregnancy, IVF procedure.  

 

Skin related autoimmune diseases. 

 

Silicone implants/injections in treatment area.

 

 

Precaution Criteria

 

 

 

Neurotoxin injection and implants in the treatment area (wait 1 month after the 

last injection before starting a treatment). 

 

Breast feeding. 

 

Epilepsy. 

 

Facial laser resurfacing and deep chemical peeling within the last month on the 

treatment area. 

 

Fresh scars or wounds, scarification of the skin on the treatment area. 

 

Telangicetasia.  

 

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). 

 

6-9 

Содержание Venus Viva

Страница 1: ...Venus VIVA User Manual Effective Date 28 07 13 P N DCVIROW3 Rev 01 User Manual International...

Страница 2: ...subject to change without notification Venus Concept Ltd has patents and pending patent applications trademarks copyrights or other intellectual property rights covering subject matter in this docume...

Страница 3: ...quirements 4 2 Connect the Applicators 4 3 Connect Disconnectiong a Tip to Scan FX Applicator 4 4 Chapter 5 Operating the System 5 1 Turning the System On Off 5 1 Login Screen 5 1 Treatment Screen 5 2...

Страница 4: ...tors 6 9 Exclusion Criteria 6 9 Precaution Criteria 6 9 Pre Treatment 6 10 General Treatment Information 6 11 Chapter 7 Maintenance 7 1 Cleaning the System 7 1 Cleaning the applicators 7 1 Disinfectio...

Страница 5: ...ation stated where you will see this symbol is extremely important and must be noted Provides general information that is important to keep in mind Waste of Electrical and Electronic Equipment WEEE Ma...

Страница 6: ...tive Date 28 07 13 P N DCVIROW3 Rev 01 S N Label Consult Instruction for Use System that includes RF transmitters or that applies RF electromagnetic energy for diagnosis or treatment Figure 1 1 Venus...

Страница 7: ...o become familiar with all safety requirements and operating procedures thereby prevent accidents injury and reduce the risk of damaging the machine The Venus VIVA is designed for professional use onl...

Страница 8: ...Venus VIVA User Manual Effective Date 28 07 13 P N DCVIROW3 Rev 01 2 Introduction View of Venus Viva System c d J g k f i a b e h J 2 1...

Страница 9: ...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 pr...

Страница 10: ...r detachable accessory Firm BX Applicator detachable accessory Scan FX Applicator detachable accessory Intended user and environment The device is intended to be used by professional practitioners in...

Страница 11: ...ve should always be in maximizing the safety of both the client and the treatment operator The Operator All operators MUST be familiar with the system controls and know how to shut down the system in...

Страница 12: ...ATIENT or other leads is avoided The product should not be in contact with other equipment Failure of the System could result in an unintended increase of output power Interference produced by the ope...

Страница 13: ...ITS CABINET Keep the bodies of the applicators clean pay particular attention to the RF electrodes of the Scan FX applicator Check the integrity of all components Do not allow the applicators to come...

Страница 14: ...pplicator to the system platform 4 Connect the Firm BX applicator or Firm FX applicator to the system platform 5 Connect the power cable to the system cable connection port 6 Plug the system s power c...

Страница 15: ...m should be placed in a room with temperature between 10 35 C 50 95 F with a relative humidity of less than 80 and altitude up to 3000m For optimal storage system should be stored in a place with temp...

Страница 16: ...ion port 2 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 3 Seat the applicator in its cradle see...

Страница 17: ...hold it in the correct orientation with the embossed T facing the top of the applicator and aligned with the top of the applicator and push it onto the applicator s connection port A until you feel it...

Страница 18: ...nd by turning on the ON OFF button located underneath the screen The ON OFF button will be illuminated in green and within 50 seconds the Login Screen See Figure 5 1 will be displayed on the system s...

Страница 19: ...Operator can control treatment parameters start and stop a treatment and access Tools screen from this screen In order to perform a treatment operator should follow these steps 1 Select the desired Ap...

Страница 20: ...or is intended for MP 2 treatments for large areas Selecting the desired applicator is done by pressing on the left and right arrows on the Applicator Selection button see Figure 5 2 marked A Each app...

Страница 21: ...cent to the rectangle icon 4 Automatic Operating Mode Button This button enables repetitive pulsing of the Scan FX applicator at a rate determined by the operator Operator can turn on the Automatic Op...

Страница 22: ...ton This button allows qualified operators to control additional parameters related to the pulse fired by Scan FX applicator Once this button is pressed Advanced Treatment screen will be displayed wit...

Страница 23: ...plicator Pulse duration can be adjusted by pressing the and buttons adjacent to the Pulse Duration indicator marked 9A Pulse duration is measured in milliseconds mSec and adjustment is made in one mSe...

Страница 24: ...pplicator see Figure 5 5 emits a radiofrequency pulse when the system is in Ready mode a tip is connected and the trigger is pulled The applicator is equipped with a light bar that indicates when the...

Страница 25: ...P N DCVIROW3 Rev 01 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...

Страница 26: ...treatment area is divided into smaller areas which are then treated individually The Interval Timer begins countdown when treatment is initiated and beeps when timer is zeroed It then begins countdow...

Страница 27: ...ssing the Tools button see Figure 5 3 marked 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 techni...

Страница 28: ...3 Set Volume Button This button allows the operator to set the volume of the system speakers Pressing the Volume button will display a new window see Figure 5 8 which controls the volume level Adjusti...

Страница 29: ...ck the system Once the Logout button is pressed the login screen will be displayed and the login code will need to be entered in order to access the treatment screen 6 Set Auto Logout Time Button This...

Страница 30: ...perator to view information regarding the system software and hardware Pressing the System Information button will display a new window see figure 5 11 showing the system Software version and the seri...

Страница 31: ...ser Manual Effective Date 28 07 13 P N DCVIROW3 Rev 01 8 Technician Mode Button This button is password protected to be used by qualified Venus Concept technicians only Figure 5 11 System Information...

Страница 32: ...ion code Expiration Date MMM DD YYYY If Expiration Date has passed and without extending it a message will appear on the screen indicating Activation Period Has Expired Expiration Date MMM DD YYYY Ple...

Страница 33: ...n the Key number displayed on the screen The representative will provide a new 16 character activation code iii Enter the new activation code on the screen and press the Confirm button marked 10B Pres...

Страница 34: ...anent implant in the treated area such as metal plates and screws or an injected chemical substance Current or history of skin cancer or current condition of any other type of cancer or pre malignant...

Страница 35: ...tment area within the last 6 months or before complete healing Treating over tattoo or permanent makeup Excessively tanned skin from sun tanning beds or tanning creams within the last two weeks As per...

Страница 36: ...ther hair growing zones if the patient does not wish to experience hair growth reduction Pre treatment Complete or update the patient s medical and physical history Exclude from treatment patients pre...

Страница 37: ...hen beginning a new treatment perform a small test spot in a non conspicuous area of the treatment site prior to the first complete session Test spots are performed to establish the following requirem...

Страница 38: ...ace the tip on the target zone perpendicular to the skin surface and with full contact with it Emit a pulse by pressing the applicator s trigger this will create a tip shaped pattern on the patient s...

Страница 39: ...anual see page 7 2 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 ev...

Страница 40: ...ually form 24 72 hours post treatment and may remain for several days The scabs should not be touched or scratched even if they itch and should be allowed to shed off naturally Blistered or ulcerated...

Страница 41: ...d return 2 3 days after treatment to ensure that no adverse events have occurred The patient should return several weeks 4 6 after the last treatment for evaluation of the treatment area Update the pa...

Страница 42: ...hyroid gland Varicose veins Pregnancy IVF procedure Skin related autoimmune diseases Silicone implants injections in treatment area Precaution Criteria Neurotoxin injection and implants in the treatme...

Страница 43: ...ns to ensure a satisfactory outcome Expected Clinical Effects Mild discomfort associated with the treatment Heat sensation will be felt both during and following the treatment Erythema could be presen...

Страница 44: ...and maintain it for the remaining time of the treatment End Point temperature should be at least 40 C but should not exceed 45 C For optimal results it is recommended to maintain the highest temperat...

Страница 45: ...Date 28 07 13 P N DCVIROW3 Rev 01 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 pa...

Страница 46: ...off the system before wiping down any of the surfaces to ensure safety The Applicators have to be cleaned after each treatment by using Germicide wipes or alternative means Please ensure that the Appl...

Страница 47: ...ays perform the cleaning procedure prior to disinfection Cleaning the tip Clean the tip s pins with a gauze pad moistened with 70 alcohol Hard debris maybe removed with a medium hard bristle brush Use...

Страница 48: ...and then turn System on If still there is no display contact your local distributor Touch Screen Does Not Respond Restart system turn system off for 2 minutes and then turn System on If the screen st...

Страница 49: ...ead Language File appears on the screen Restart system turn system off for 2 minutes and then turn System on If the message still appears contact your local distributor The message The Machine is Lock...

Страница 50: ...3 Rev 01 Again appears on the screen Try to set login code again The message Invalid Activation Code Please Enter New Activation Code appears on the screen Try to enter the activation code again If th...

Страница 51: ...urations Input Voltage 100 120 240V 350W MAX 50 60Hz Output RF Frequency 1MHz 460KHz Fuse 3 15A 250V Max RF Output Power Firm BX and Firm FX applicators Up to 120W Max Output Energy Scan FX applicator...

Страница 52: ...Venus VIVA User Manual Effective Date 28 07 13 P N DCVIROW3 Rev 01 9 2...

Страница 53: ...not extend to any product that is modified or altered is not maintained to the Company s maintenance recommendation is operated handled or stored in a manner other than that specified by the Company...

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