Table of Contents
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Table of Contents
Related Manuals for InMode VOTIVA
Summary of Contents for InMode VOTIVA
- Page 1 Operator Manual...
- Page 2 Copyright © InModeMD Ltd, Date: October, 2017 All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of InMode MD Ltd. InMode MD Ltd Tabor House, Industrial Park South Yokneam 2069201, POB 44, Israel...
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Page 3: Table Of Contents
SECTION 4 - DESCRIPTION OF DEVICE .................... 18 ..............................18 ANEL ..................18 RONT ANEL AND PERATOR ONTROL ANEL ..........................20 OFTWARE CREENS ............................26 OUND NDICATOR ......................26 EMPERATURE ONTROL ..............................26 ANDPIECES SECTION 5 - SYSTEM OPERATION ..................... 29 .............................29 EVICE TART ..........................29 YSTEM HUTDOWN Votiva Operator Manual DO607094B... - Page 4 NCE A ............................43 NCE A SECTION 9 – TROUBLESHOOTING ..................... 44 ...........................44 ESCRIPTION OF AULTS SECTION 10 - SYSTEM SPECIFICATIONS ..................45 ...........................46 UTPUT OWER URVES EMC S ............................47 AFETY IEC60601-1-2, / 5.2.2.1 & ....................51 ABLE FROM Votiva Operator Manual DO607094B...
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Page 5: Section 1 - Introduction
Votiva System which employs Radio-frequency (RF) technologies for various aesthetic applications. The Votiva System with FormaV Handpiece is a genital device for therapeutic use, an electrically operated device intended and labeled for therapeutic use in the treatment of sexual disfunction or as an adjunct to Kegel’s exercise (tightening of the muscles of the... -
Page 6: Conventions Used In The Manual
Conventions Used in the Manual The following conventions in the form of notes and warnings are used in this manual: Provides general information that is important to keep in mind. WARNING! This information is extremely important! ATTENTION! Consult Accompanying Document. Votiva Operator Manual DO607094B... -
Page 7: Explanation Of The Symbols Used On The System
Follow instructions for use Federal (US) law restricts this device to sale by the order of a physician licensed by the law of the state in which he practiced to use or order the use of the device Votiva Operator Manual DO607094B... -
Page 8: Section 2 - Safety
Make sure that all treatment personnel are familiar with the System controls and know how to shut down the System instantly. There are no user-serviceable parts in the system, and all service and repair must be performed only by the factory or authorized field service technicians. Votiva Operator Manual DO607094B... -
Page 9: Cautions
System is used. Safety Features of the System The System incorporates the following safety features. All personnel operating the System should be familiar with these features: • System has unique password to avoid device operation by non-authorized personnel. Votiva Operator Manual DO607094B... -
Page 10: Safe Use Of The Active Accessories
RF. • Do not connect a wet accessory to the System. • Do not immerse the applicator under water at any time. Votiva Operator Manual DO607094B... -
Page 11: Warnings
Warnings This equipment is for use only by trained, licensed physicians. Only handpieces manufactured or approved by InMode MD Ltd. should be used with System. Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit. -
Page 12: Device Labels
As required by national and international regulatory agencies, appropriate warning and information labels have been attached in specific locations on the instrument as identified below: Figure 2.1 System certification and identification label Figure 2.2 Footswitch label Votiva Operator Manual DO607094B... -
Page 13: Handpiece Labels
Handpiece. The following labels are located on the Handpieces: Manufacturer identification labeling is placed on the hand pieces. Figure 2.3 The Plus90 (FormaV) Handpiece label Figure 2.4 The FRACTORA Handpiece label Votiva Operator Manual DO607094B... -
Page 14: Equipment Classification
• Not suitable for use in presence of flammable substance • Power receptacle must include protective earth, and must be checked before connecting the system. The Votiva system with the Handpieces is classified as class II device by CDRH. Votiva Operator Manual DO607094B... -
Page 15: Section 3 - System Installation
• For optimal operation of the System, maintain room temperature between 20º-27ºC (68º-79ºF) and relative humidity of less than 80%. Equipment List The System includes the following: • System platform • Handpieces • Handpieces cradles • Footswitch • Operator manual • Power cord Votiva Operator Manual DO607094B... -
Page 16: Unpacking
Unpacking In order to unpack the device: 1. Remove the paper strip and open the box 2. Remove accessories and foams around the device. 3. Take device out of the box using top and bottom handles. Votiva Operator Manual DO607094B... -
Page 17: Installation
Disposal of System To comply with European Commission Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE) and other country and state regulations, please DO NOT dispose of this equipment in any location other than designated locations. Votiva Operator Manual DO607094B... -
Page 18: Section 4 - Description Of Device
Located on the upper right side of the front panel. Handpiece Connector Front Panel and Operator Control Panel The Operator Control Panel is located on the upper side of the System. The Operator Control Panel consists of an LCD touch screen. Votiva Operator Manual DO607094B... - Page 19 LCD screen shows information about system mode and treatment parameters. The panel allows changing treatment parameters and system mode. Power electronics is not activated if Handpiece is not connected to its connector on the front panel. Votiva Operator Manual DO607094B...
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Page 20: Software Screens
The Splash screen appears after the On-Off switch is turned on. Figure 4.2 Splash Screen *The version number will be displayed according to the software version. After entering the individual code in the Login Screen, non-authorized use of the device is prevented. Figure 4.3 Login Screen Votiva Operator Manual DO607094B... - Page 21 Menu Screen appears, Figure 4.4 Menu Screen Menu Screen allows selection of connected Handpiece or entering Utilities Screen. Figure 4.5Utilities Screen Utilities Screen contains: Volume Volume. This function allows the user to adjust system volume. Votiva Operator Manual DO607094B...
- Page 22 Figure 4.6 FormaV Treatment Screen Selection The frame selects parameters that can be changed by functional keys. Frame Energy Delivered energy is changed from level 20 to 40 and the System starts up at the minimal energy setting. Votiva Operator Manual DO607094B...
- Page 23 Return to Main Menu to select another applicator and change the applicator if needed. Figure 4.7 FRACTORA Treatment Screen Selection The frame selects parameters that can be changed by functional keys. Frame Tip Type Allows selecting between different tip types of FRACTORA. Votiva Operator Manual DO607094B...
- Page 24 Tip Type 24 pin tip is compatible with deep fractional coagulation and ablation of tissue. Energy Delivered energy is changed from level 20 to 40 energy levels and the System starts up at the minimal energy setting. Votiva Operator Manual DO607094B...
- Page 25 Any attempt to change the treatment settings switches the system to Standby mode. When the signal from the footswitch is indicated, the system switches to Active mode. Any attempt to change the treatment settings switches the system to Standby mode. Votiva Operator Manual DO607094B...
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Page 26: Sound Indicator
Handle is made of metal and has ergonomic design for easy treatment with high visibility of the treated area. Cable has a length of 250cm (100’’). Connector is connected to the front panel of the system. Votiva Operator Manual DO607094B... - Page 27 Cable has a length of 250cm (100’’). Connector It is connected to the rear panel of the system. Votiva Operator Manual DO607094B...
- Page 28 60 pins are 600µ long, and 24 pins are 2500µ long. With FractoraV only 24 pins to be used. With FRACTORA all types of tips can be used. Figure 4.11 FRACTORA Tips: Left 60 pin; Right 24-pin (coated/noncoated) Votiva Operator Manual DO607094B...
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Page 29: Section 5 - System Operation
9. Select Ready mode to confirm the selected parameters. The System is ready for pulsing. 10. Press footswitch to start the treatment. System Shutdown To shut down the system turn the On-Off switch off. Turn the Main Power switch off at the end of the day. Votiva Operator Manual DO607094B... -
Page 30: Section 6 - Formav Treatment Information
Information Indications for Use The Votiva System with FormaV Handpiece is a genital device for therapeutic use, an electrically operated device intended and labeled for therapeutic use in the treatment of sexual disfunction or as an adjunct to Kegel’s exercise (tightening of the muscles of the pelvic floor to increase muscle tone). - Page 31 In such a case, a small area should be treated and assessed a few days later to determine if the patient will tolerate the treatment without developing adverse effects. Votiva Operator Manual DO607094B...
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Page 32: Possible Adverse Effects
1. Thoroughly clean the Handpiece with 70% alcohol absorbed pad for at least 30 sec and repeat as necessary. 2. Leave it for complete drying. Pre-Use Check: Before each use of the Handpiece, the device must pass the following: Votiva Operator Manual DO607094B... -
Page 33: Pre-Treatment Recommendations
• Gel to be applied directly to all 3 electrodes on FormaV tip. • Pre-warm the gel by covering the tip electrodes completely and applying RF for a few seconds. • Inserting gel manually into the vaginal canal may be helpful in cases of moderate to severe atrophy. Votiva Operator Manual DO607094B... - Page 34 9. Slight erythema and edema is a typical immediate response. However, when there is excessive tissue reaction, stop treatment. For excessive heat sensation, you may increase the movement speed, reduce the RF power and lastly, reduce the cut-off temperature. If this does not help stop the treatment. Votiva Operator Manual DO607094B...
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Page 35: Treatment Schedule
• The Handpiece should be cleaned from the gel and disinfected by 70% alcohol. • The tip should be disposed Votiva Operator Manual DO607094B... -
Page 36: Section 7 - Fractora/Fractorav Treatment Information
Severe concurrent conditions, such as cardiac disorders or sensory disturbances. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications. Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in Votiva Operator Manual DO607094B... -
Page 37: Possible Adverse Effects
Crusting from the ablated dots will exfoliate naturally after 1-3 weeks. Occasionally, at energy level above 30, there is a potential low-level stimulation of branches of the facial nerve and there will be some involuntary contraction of the Votiva Operator Manual DO607094B... -
Page 38: Pre-Treatment Recommendations
40-62 energy levels, depending on the percent numbing ingredients and patient sensitivity. o A few patients require nerve block for higher energy, limited to central face. o Tumescent or IV sedation is applied usually when FRACTORA follows an invasive procedure. Votiva Operator Manual DO607094B... -
Page 39: Tip Cleaning Instructions Prior To Use
Make sure that hand piece is dry before use. Test Spots A small test spot should be performed in a non-conspicuous area of the treatment site, prior to the first complete session. Test spot is performed to establish the following requirements: Votiva Operator Manual DO607094B... -
Page 40: Treatment Recommendations
Use lower energy (~20%) for thin skin like neck or bony area like forehead. When working on thin skin over bone, such as hand dorsum or chest, further reduce energy (~20%). Votiva Operator Manual DO607094B... -
Page 41: Treatment Schedule
Treatment should be concluded when the results are satisfactory to the patient or according to the physician's discretion. Generally, 3-5 sessions are needed for mild to moderate depth settings. It is not typical to perform more than five consecutive sessions. In some instances, 1-2 sessions may be sufficient. Votiva Operator Manual DO607094B... -
Page 42: Post-Treatment Recommendations
• For Asian patients and skin type IV and V, bleaching ointment should be prescribed for 6-12 weeks, 2-3 times a week following the healing of treatment area (typically 7 days) to minimize risk of post inflammatory hyper-pigmentation. It should be stopped 48-72 hours before another FRACTORA session. Votiva Operator Manual DO607094B... -
Page 43: Section 8 - System Maintenance
System. Once a Year By Authorized Service personnel only: System and Handpieces full test and calibration is recommended. Please make sure to contact your local service center to perform this process. Votiva Operator Manual DO607094B... -
Page 44: Section 9 - Troubleshooting
• Replace Handpiece • Call Technical Service if problem persists Fault H8005 – System Memory Fault • Call Technical Service if problem persists Faults H8003, H8006, H8007 - RF Related Faults • Call Technical Service if problem persists Votiva Operator Manual DO607094B... -
Page 45: Section 10 - System Specifications
20.000 Kg [44 lbs.] FormaV Applicator 0.22 Kg [0.5 lbs.] FractoraV Applicator 0.22 Kg [0.5 lbs] Fractora RF Maximum Output 62 [energy level] energy FormaV RF Maximum Output 40 [energy level] energy RF Frequency 1[MHz] ± 2% Votiva Operator Manual DO607094B... -
Page 46: Output Power Curves
Output Power Curves The curves that follow depict the changes for each mode at specific power settings. Full Power Half Power 1000 Load [ ] Figure 9.1 Output Power Versus Impedance Votiva Operator Manual DO607094B... -
Page 47: Emc Safety
• The system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the system should be observed to verify normal operation in the configuration in which it will be used. Votiva Operator Manual DO607094B... - Page 48 (50/60 Hz) magnetic fields should be at levels field IEC 61000-4-8 characteristic of a typical location in a typical commercial or hospital environment. NOTE - U is the AC mains voltage prior to application of the test level. Votiva Operator Manual DO607094B...
- Page 49 If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the system. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Votiva Operator Manual DO607094B...
- Page 50 NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Votiva Operator Manual DO607094B...
- Page 51 Table from IEC60601-1-2, / 5.2.2.1 c&f Votiva Operator Manual DO607094B...
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