Novoxel Tixel2 User Manual

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Summary of Contents for Novoxel Tixel2

Page 2: Table Of Contents
The Tixel2 Handpieces ..........................18 Handpiece/s Receiving Inspection – Content and Functionality Verification ......... 21 Installation ..............................22 Turning on the Tixel2 device & Operating the Touchscreen ..............26 The Home Screen ............................. 26 The Operating Screen ..........................28 Pulse Credit & the Pulse Credit Screen ....................31 Purchasing of Pulse Credit ........................
Page 3 Maintenance ............................. 59 Product Lifetime ............................59 Technical Device Service ......................... 59 Cleaning ..............................59 Cleaning the Tixel2 Handpiece Distance Gauge (the DG) ..............59 Storage and Packaging ..........................60 Device Storage ............................60 Disposal ..............................60 Periodic Inspection & Service Instructions ....................60 Annual Inspection by Certified Local Representative ................
Page 4 It is fully within the operator’s responsibility to verify that the use of the Tixel2 is permitted under local law. Using the product requires technical skills and basic knowledge of English. It is therefore essential that only skilled, specialized and trained staff or with the required skills be allowed to use the product.
Page 5 User Manual TXLD0012 This page intentionally left blank Page | 4 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 6: Scope
User Manual TXLD0012 Chapter 1: Introduction Scope This document is the formal user manual for the Tixel2 device (P/N TXLD0012) which is a part of the ® Tixel Product Family. It provides important information regarding device safety, installation and setup, operation, maintenance and service.
Page 7: Glossary, Conventions, Abbreviations, Signs And Symbols
The Tixel2 arrives with a complimentary pulse credit. Once exhausted, more pulse credit may be purchased by the customer. The Tixel2 device may be operated in either single or double pulse mode, which means that pressing the trigger of the Tixel2...
Page 8: Abbreviations
User Manual TXLD0012 Abbreviations Abbreviation Definition The technology platform powering the Tixel2 device is named Thermo-Mechanical Action (or TMA). The principle of operation is described further down this manual. For further information regarding this technology, refer to our website: www.Novoxel.com The Tixel2 Handpieces or any other applicable Handpiece.
Page 9: Signs And Symbols
Indicates a hazardous situation, which, if not avoided, could result in minor or moderate injury. Indicates a hazardous situation, which, if not avoided, could result in death or serious injury. Hot! Do not touch, risk of injury. Page | 8 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 10: Operating State, Location And Position
Operating State, Location and Position The product may be operated only in full compliance with the operating  ® conditions and in the positions specified by Novoxel The product's ventilation should not be obstructed.  Following are the required operating position and conditions: Do not place the product on surfaces or tables that (for reasons of weight or stability, etc.) are...
Page 11 The product is not liquid-proof; therefore, the equipment must be protected against penetration of  liquids. If the necessary precautions are not taken, the user may suffer electric shock or the product itself may be damaged, which can also lead to personal injury. Page | 10 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 12: Environmental Protection
Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority for recycling advice or contact your Novoxel product retailer for more information. The disposal of the Tixel system and/or components should be performed according to the WEEE directive 2012/19/EU.
Page 13: Applicable Standards
Tip with the skin. The duration of tissue contact (and subsequent thermal energy transfer) is precisely modifiable. The Tixel2 may perform a limited number of pulses, as ordered by the customer. Once the purchased amount of pulses has been exhausted, an additional amount may be purchased. It is enabled by entering a code, provided by Novoxel, directly on the device or via a dedicated mobile application.
Page 14: System Layout And Components
User Manual TXLD0012 System Layout and Components The Tixel2 device’s general layout and components are displayed in figure below. The Tixel2 Device P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 13...
Page 15 User Manual TXLD0012 The Tixel2 Components The main components of the Tixel2 are specified in the following table: Number Part Name Tixel2 Console Console touchscreen 3.1, 3.2 Tixel2 Handpieces (left and right, respectively). 4.1, 4.2 Handpiece cradles (left and right, respectively).
Page 16: Principle Of Operation And System Components
The standard Tip is a biocompatible reusable metallic element covered by a layer of Titanium. The Tip is a reusable component of the Tixel2 device. The front of the Tip consists of the treatment surface which is comprised of an array of 9 × 9 metallic pyramids (81 in total), which when heated, are capable of creating (via thermal coupling with the tissue) small-diameter micropores upon brief contact with the skin (a few milliseconds).
Page 17: The Periorbital Tip
Possible durations for double pulse: 6-16)  Pulse protrusion 100-1,000 µm (microns), intervals of 100 µm Maximal allowed number of 250,000 pulses per Tip 25,000 for any new Tixel2 device HP (regard-less of Handpiece and Tip Initial complimentary pulse credit types) ® Novoxel Tips Specifications Page | 16 Novoxel.com...
Page 18 The layer acquires some mild colors such as blue, dark purple, and brown. This is a normal phenomenon in heat-treated titanium. The tip is pre-conditioned by heat during manufacturing, as it is important to create the oxidation layer for prevention of tissue adhesion. It is biocompatible. P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 17...
Page 19: The Tixel2 Console
Decorative LED light frame.  The Tixel2 Handpieces The HP is a handheld component of the Tixel2 device, used to perform treatment by producing mechanical ® motion of the Novoxel Tip, which is mounted on its distal end. Each of the Handpieces are plugged into the console by a 1.5m (~5ft.) cable, which supplies power, control and enables cooling of the HP by...
Page 20 Distance Gauge). Each HP also automatically sterilizes the Tip before each treatment session. Both Handpieces are shown below: Distance Gauge Trigger The Tixel2 Handpiece Configurations - Left is periorbital, Right is Standard The Handpiece consists of: A trigger activated electric motor.  A motion control apparatus.
Page 21 The Handpiece has a usage limit of 250,000 pulses. After this number of pulses or after 3 years (the earliest), the expired HP should be sent for service. A notification will be dis-played on the Console’s touchscreen accordingly. Page | 20 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 22: Handpiece/S Receiving Inspection - Content And Functionality Verification
Chapter 3: Package Contents & the Unboxing Process The Tixel2 system is supplied in rigid packaging. Open the box and place all components on a dry, stable, clean surface. The Tixel2 device is provided with a Tip, mounted on the Handpiece.
Page 23: Installation
Console. You may pull the cradle slightly out for convenience, but always make sure it is firmly held in the Console. Connecting the Handpiece Cradles Page | 22 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 24 Placing the Handpiece in the Console's Cradle Ensure a safe path for the Handpiece’s cord, to prevent any undesired kinks, twists  or pinches. It is allowed to operate the device using a single Handpiece.  P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 23...
Page 25 The Handpiece connector inlet and the Handpiece connector are depicted in the following image set. Note the Handpiece’s connector designated insertion notch and the matching console’s inlet insertion slot. Plug the Tixel2 Handpiece connector into the Tixel2 Console inlet. Fully insert until a ‘Click’ is heard. Follow the instructions in the following figures:...
Page 26 Power Inlet on the Console's Back Panel Never disconnect a Handpiece under load. It must be connected/disconnected only after the system has been shut down. Neglecting to do so may result in system damage. P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 25...
Page 27: Turning On The Tixel2 Device & Operating The Touchscreen
User Manual TXLD0012 Chapter 4: Operating Instructions Turning on the Tixel2 device & Operating the Touchscreen Turn the system on by switching the I/O switch in the back panel of the Console to “I”. A system check will be performed, including a test pulse by each of the Handpieces.
Page 28 Note: the accuracy of the temperature measurement is ±5° Celsius. The Shutdown icon. Home Screen Features Icon Count Range 1 - 200,000 201,000 - 240,000 240,001 - 245,000 Over 245,000 (icon blinks) Handpiece Pulse Counter Color Index in the Home Screen P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 27...
Page 29: The Operating Screen
Neglecting to do so may result in system damage. The Operating Screen The Operating screen allows selection of the desired Handpiece and treatment parameters. Operating Screen Page | 28 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 30 The icon will blink until treatment parameters are selected (see indents 4, 5 & 6 further below in this table). After the treatment parameters have been selected, the Handpiece will become active; The green icon will be displayed continuously and treatment can be performed. P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 29...
Page 31 Ready to work: Red 385-400°; Orange 200-384°; Yellow 80-199°; Blue 0-79°. Handpiece heating will be indicated by a small upward arrow icon (˄) located above the Handpiece temperature indication. Handpiece cooling will be indicated by a small downward arrow (˅). Page | 30 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 32: Pulse Credit & The Pulse Credit Screen
Pulse Credit & the Pulse Credit Screen The Tixel2 is provided with an initial pulse credit of 25,000 pulses. The credit is counted per device. This means that any compatible Handpiece may be connected to the Console, allowing consumption of the pulse credit.
Page 33: Entry Of Credit Codes Via The Device's Pulse Credit Screen - Via The Home Screen
How to display The Pulse Credit Screen In order to feed a new code to the Tixel2 device, return to the home screen. Press and hold on the letter “e” of the logo of the Tixel2 for four seconds.
Page 34: The Novoxel Application
 The Novoxel Application Pulse credit may also be renewed via Novoxel’s designated applications, available for Android and iOS users. The application requires an active Bluetooth connection to the Tixel2 device. When additional pulse credit is purchased, a message is sent to the customer, with a link to download the software in addition to the code itself and operation instructions.
Page 35: System Shutdown
Cool-down of the Handpieces will be performed, followed by the following screen: Shutdown Screen After the Shutdown screen has been displayed, switch the system off via the power switch on the back panel of the Console. Page | 34 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 36 User Manual TXLD0012 Chapter 5: Troubleshooting The following Table describes all notifications/error screens which may be displayed during the operation of the Tixel2 device: Item # Description The Handpiece which was pre-selected in the Home screen, will be heated to working temperature (400°C) and sterilized.
Page 37 Handpiece is heating up beyond the allowable range. Please shut down, restart and try again. If error persists call service. E-004 Handpiece not connected. Please disconnect Handpiece and reconnect properly and then restart. If error persists, call service. Page | 36 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 38: Tip Cleaning
 Follow all safety instructions and storage for this material and its use, provided by its supplier. A standard, clean, electrical rotating toothbrush (provided by Novoxel).  For the Distance Gauge cleaning only 70% Pharmacopoeia (medical) grade alcohol (70% Ethanol).
Page 39 Select the Handpiece you would like to clean by pressing on its icon. After your selection, the following screen will be displayed, instructing you to remove the Handpiece’s DG. Remove the Handpiece’s Distance Gauge Page | 38 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 40 Handpiece occurs. Always perform Distance Gauge removal with both hands holding the Handpiece and facing the Tixel2 Console. Place the DG on a clean and dry surface.
Page 41 Lightly soak the brush in the IPA fluid. Hold the Handpiece with the Tip pointing downwards.  Activate the brush and brush the Tip for 30 seconds at least, until visibly clean, as demonstrated  below: Correct Brushing of the Tip Page | 40 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 42 The following screen will be displayed: Tip Heat Cleaning is Performed; A 6:00 Minute Countdown is Displayed After 6:00 minutes, the cleaning process has been concluded, the Operate screen will be displayed. P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 41...
Page 43: Tip Sterilization
“Operate” screen, which has been described previously in this document. The process is 1:00 minute long. The Tixel2 device will notify when the sterilization process has been completed and the device is ready.
Page 44: Intended Use
Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial  treatment or plans for such treatment during the course of the Tixel2 device treatment, or before complete healing of such treatments has occurred. Any patient who takes or has taken any medications (including via topical application), herbal ...
Page 45: Intended User
Any patient who underwent thread lifting of the area to be treated in the last 3 months.  Intended User The operation of the Tixel2 device, including any of its components, is restricted to trained, qualified and professionals and must be under the supervision of a physician. Intended Treatment Areas...
Page 46: In-Clinic Pre-Treatment Patient Preparation
In following treatment sessions, higher intensity may be reached gradually cord to the patient’s response, treatment tolerance and physician’s discretion. P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 45...
Page 47 The table is designated for normal skin type. In case of thinner skin, decrease preliminary protrusion by 100 microns at least. b. Such as Mediterranean, Middle-Eastern, Asian, Indian. c. Perform follow-up to examine the patient’s response. d. Perform follow-up after each session to examine the patient’s response. Page | 46 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 48: Single Pulse Treatment Characteristics For Caucasian Fitzpatrick I-Iv Skin Phototypes
Applying higher intensity parameters than denoted in the aforementioned segment should be  performed with caution and in accordance with the physician’s discretion, for example in cases of thick skin. P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 47...
Page 49: Device Preparation
During treatment, manual pulse overlapping of pulses is not prohibited, but should be pursued with caution. It is advised to perform the treatment in a pre-determined, systematic, directional manner. Page | 48 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 50: Criss-Cross Mode
When working below the eyes (always maintain safe distance from the eyes), apply minimal stretching by hand in order to avoid skin folding. Position the Handpiece perpendicularly to the skin prior to activation, as demonstrated in the  following figure: P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 49...
Page 51: Frame Segments
Area Specific Treatment guidelines:  Frame Segments: The Tixel2’s principle of operation relies on forwarding the Tip towards the skin for a controlled  pulse. Due to the fact that areas such as the jawline, forehead, back of hands, etc., are more sensitive, it is recommended to apply lower intensity parameters when treating such segments.
Page 52 All precautions should be followed, particularly when working close to the eyes. Décolleté (Chest): Flatten the treated segment when treating patients with loose skin. Move the skin  slightly when treating bony segments. P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 51...
Page 53: Specific Skin Irregularities: Moles/Open Sores
Apply the ointment gently and avoid rubbing. Do not cover or cool the patient’s skin after applying  the lotion. No steroidal cream may be applied during the healing period. Page | 52 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 54: Typical Patient Response To Treatment
Typical Patient Response to Treatment Example # 1 Before Treatment (Left) / Immediately After Treatment (Right) Crusting, 3 Days After Treatment; on the Right - An Enlarged View of the Left Cheek P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 53...
Page 55 User Manual TXLD0012 One Month After Treatment Page | 54 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 56: Example # 2
User Manual TXLD0012 Example # 2 Before Treatment (Left) / Immediately After Treatment (Right) Crusting, 5 Days After Treatment (Left) / One Month After Treatment (Right) P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 55...
Page 57: Post-Treatment Patient Guidance
Other medical/aesthetic treatments not informed to the supervising physician.  Safety Guidelines General Safety: Supervising Physician The Tixel2 device should have a supervising physician.  The supervising physician should establish the treatment parameters.  Warnings and Precautions: Patient & Operator Routine Operation Safety It is advisable to inform the patient regarding the nature of the treatment.
Page 58: Expected Possible Complications And Adverse Effects
Damage to any of the device’s components, especially the Tip, may lead to system malfunction. In case of such damage, please contact your vendor. ® The Novoxel Tip may be used only as a component of the Tixel2 device, in the specific fashion  portrayed in this document. The Tixel2 device and the Novoxel ®...
Page 59 Herpes Simplex  Local bacterial infection.  In case of any of the occurrence of any side-complication or adverse effect, it is imperative to consult  a physician within a short period. Page | 58 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 60: Maintenance
1,250 treatments during a period of 3 years). Technical Device Service In any case of malfunction, the Tixel2 system should be serviced only by qualified, trained and certified service personnel. For any service issue, contact your local vendor. Cleaning Clean the Tixel2 device and the Tixel2 Handpieces with 70% medical grade alcohol prior to each ...
Page 61: Storage And Packaging
The device may remain plugged in to an in-wall power source while not in use. Prior to routine  storage, make sure the Tixel2 device is turned off. The Tixel2 device should be placed on a stable, dry and clean surface. The Tixel2 Handpiece may remain plugged in as well.
Page 62: Annual Inspection By Certified Local Representative
DG lumen’s center is allowed. Adequate Centering of the Tip within the Distance Gauge. Perform a pulse to inspect the centering of the Tip throughout the forward and back motion. P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 61...
Page 63 Verify that the white LED in the Handpiece is lit.  Handpiece maintenance after 250,000 pulses or 3 years operation.  Each Handpiece should be serviced by your local distributor after reaching 3 years of operation or  250,000 pulses. Page | 62 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 64: Essential Performance
EMC information provided in this document. This declaration only applies to the ® following Novoxel device: Tixel2 TXLD0012. This device is intended for use in the electromagnetic environment specified below. The operator of the device should verify that the device is operated in such an environment.
Page 65 IEC 61000-4-11 powered from an uninterruptible power 0% U for 250/ 0% U for 250/300 supply or a battery. 300 cycles cycles Page | 64 Novoxel.com P/N T2-UM-E-ENG Rev 10...
Page 66 IEC 61000-4-3 10 V/m [E] = 10 V/m Radiated RF 80 MHz to 2.7 GHz 385 MHz 27 V/m 28 V/m Proximity fields from RF wireless communications 9 V/m equipment. 28 V/m P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 65...
Page 67: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Device
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 Tixel2, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
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Page 69 oduct speciﬁcations ar...

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