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User Manual TXLD0012

 

P/N T2-UM-E-ENG Rev 10                                             Novoxel.com

 Page | 5

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.

Introduction

This Manual

This manual contains important information regarding the Tixel2 device. In order to ensure the safety of

both operator and patient, as well as achieving optimal treatment results, please read this manual prior to

setup and operation. Verify that you are familiar with all safety instructions, guidelines, warnings and

precautions as well as the device’s operating principles.

Specifications of This Manual

This Manual’s Specifications

Novoxel

®

 Part Number:

T2-UM-E-ENG Rev 10

Document Release Date:

January 2020

Applies for:

The Tixel2 device (Part No. TXLD0012)

Software Classification

B

Software Version:

SW Version V1.20r

Chapter 1: Introduction

Summary of Contents for Tixel2

Page 1: ...PDBM VUIPSJ FE 3FQSFTFOUBUJWF PO 6 QMBDF TUJDLFS XIFO BQQMJDBCMF POMZ...

Page 2: ...bital Tip 16 The Tixel2 Console 18 The Tixel2 Handpieces 18 Handpiece s Receiving Inspection Content and Functionality Verification 21 Installation 22 Turning on the Tixel2 device Operating the Touchs...

Page 3: ...reatment Patient Guidance 56 Safety Guidelines 56 General Safety Supervising Physician 56 Warnings and Precautions Patient Operator Routine Operation Safety 56 Expected Possible Complications and Adve...

Page 4: ...your responsibility as the operator to use the product appropriately You are also responsible if the product is used for any intention other than its designation purpose or if the instructions in this...

Page 5: ...User Manual TXLD0012 Page 4 Novoxel com P N T2 UM E ENG Rev 10 This page intentionally left blank...

Page 6: ...the Tixel2 device In order to ensure the safety of both operator and patient as well as achieving optimal treatment results please read this manual prior to setup and operation Verify that you are fa...

Page 7: ...pulse or the pulse duration is controlled by the Tixel2 device s Graphic User Interface or GUI The Tixel2 arrives with a complimentary pulse credit Once exhausted more pulse credit may be purchased b...

Page 8: ...ng 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 ww...

Page 9: ...rt Classification by IEC 60601 1 Consult Instructions for Use Waste of Electrical and Electronic Equipment WEEE Compliance Symbol Indicates the possibility of incorrect operation which may result in d...

Page 10: ...0 80 Novoxel recommends that an ambient temperature of 20 to 25 C 68 to 77 F and relative humidity of 40 60 be maintained during normal operation as this will result in better performance and in longe...

Page 11: ...r cable is damaged Check the power cable on a regular basis to ensure that it is in proper operating condition By taking appropriate safety measures and carefully laying the power cable you can ensure...

Page 12: ...isconnect it completely from the power supply Service procedures or replacement of any parts of the device should be performed only by qualified service personnel Do not push any objects or fingers in...

Page 13: ...Waste IEC 60601 1 1 9 The Tixel2 device Overview The Tixel2 is a thermo mechanical fractional skin treatment device which employs a specialized thermal component the Tip to generate a matrix of either...

Page 14: ...User Manual TXLD0012 P N T2 UM E ENG Rev 10 Novoxel com Page 13 System Layout and Components The Tixel2 device s general layout and components are displayed in figure below The Tixel2 Device...

Page 15: ...ts Number Part Name 1 Tixel2 Console 2 Console touchscreen 3 1 3 2 Tixel2 Handpieces left and right respectively 4 1 4 2 Handpiece cradles left and right respectively 5 1 5 2 Handpiece umbilical cable...

Page 16: ...aseline position safely secured and remote from the patient s skin and the operator within the Handpiece s distance gauge The pulse can also be modified by the user to single pulse or double pulse mod...

Page 17: ...s is 0 3 cm Novoxel Tips Specifications Tip Description General Specifications and Operating Parameters Size Height Length Width approximated Standard H 6 5mm X L15mm X W15mm Periorbital H 13mm X L15m...

Page 18: ...ded regarding the Tip is relevant for both Tip configurations Oxidation layer on Tip surface Following high temperature heating a thin oxidation layer is formed on the Titanium The layer acquires some...

Page 19: ...Handpieces 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 mou...

Page 20: ...l Right is Standard The Handpiece consists of A trigger activated electric motor A motion control apparatus Tip heating element A Distance Gauge or DG The Distance Gauge is attached to the Handpiece o...

Page 21: ...ated by trigger the HP performs a pulse forwarding the Tip to the skin and then retracting it back to its home position The Handpiece has a usage limit of 250 000 pulses After this number of pulses or...

Page 22: ...atched The Tip is centered in relation to the Distance Gauge when the Tip passes through it In case of any fault contact your vendor Item Description Quantity 1 HandpieceTixel2 Console x 1 2 HP Cradle...

Page 23: ...dles are packed separately from the Console Insert each cradle s legs marked by the red square fully into the designated holes on each side of the Console You may pull the cradle slightly out for conv...

Page 24: ...piece in the Console s Handpiece cradle as shown in the following illustration Placing the Handpiece in the Console s Cradle Ensure a safe path for the Handpiece s cord to prevent any undesired kinks...

Page 25: ...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 i...

Page 26: ...e Make sure the I O button of the console is switched off Connect the power cable to the power inlet marked in yellow on the Console s back panel and to a suitable power source according to the system...

Page 27: ...he 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 H...

Page 28: ...rature of 200 C during the process The pulse count of each Handpiece is displayed below the icon together with a color visualization of the remaining life of the Handpiece see Handpiece pulse count co...

Page 29: ...w Handpiece is connected The Left and Right Handpiece Expiration Notification Screens The Operating Screen The Operating screen allows selection of the desired Handpiece and treatment parameters Opera...

Page 30: ...formed Note The other Handpiece will remain at hibernation temperature 200 C indicated by an orange icon Preparing the Second Handpiece for Operation Press on the hibernated Handpiece icon The second...

Page 31: ...working temperature 2 Indication of the selected Handpiece 3 End of session and return to the Home screen 4 Selection De selection of the Double Pulse option This option will be displayed for pulse d...

Page 32: ...ulse Credit In order to purchase a new code contact your local distributor Please make sure you have your user name or request this information from your vendor together with the serial number of the...

Page 33: ...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 The following screen will be d...

Page 34: ...tion 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 In...

Page 35: ...UM E ENG Rev 10 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 th...

Page 36: ...inuously and treatment can be performed Note The other Handpiece will remain at hibernation temperature 200 C indicated by an orange icon Preparing the Second Handpiece for Operation Press on the hibe...

Page 37: ...ase the Handpiece connection does not solve the problem shutdown as described in sub section 4 5 wait for 15 seconds and turn the system back on This icon accompanies fatal error notifications which r...

Page 38: ...l Cleaning should be performed using disposable gloves Press on the Tip Cleaning Button in the left upper corner of the Home Screen Tip Cleaning Screen Temperature adjustment The system will prepare t...

Page 39: ...as been reached the following screen will be displayed Temperature Achieved Screen Select the Handpiece you would like to clean by pressing on its icon After your selection the following screen will b...

Page 40: ...Gauge After removal of the Distance Gauge the exposed Tip may be hot The operator and or any other person s standing nearby may be injured if contact with the distal end of the Handpiece occurs Alway...

Page 41: ...llowing screen will be displayed instructing you to commence cleaning Indication to Clean the Tip Lightly soak the brush in the IPA fluid Hold the Handpiece with the Tip pointing downwards Activate th...

Page 42: ...lect to perform cleaning of the second Handpiece as well Acountdown of 30 seconds will be displayed in which you may add the second Handpiece to the cleaning process by pressing on its icon If selecte...

Page 43: ...the user and their confirmation in the 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...

Page 44: ...be exposed to the sun for short periods of time occasionally are not contra indicated as long as they apply a high SPF sunscreen 50 Herpes Simplex Current skin cancer malignant sites and or advanced p...

Page 45: ...h demonstrates any of the following should be avoided Hyperpigmentation hypopigmentation burrowing hair skin wounds and or sores infection or septic conditions skin inflammation hemorrhage or risk of...

Page 46: ...r is not recommended Dry the patient s skin Disinfect the patient s skin using an antiseptic lotion such as Septeal by Pierre Fabre Dry the patient s skin Determination of Treatment Parameters First T...

Page 47: ...dations table Suggested Treatment Parameters Double pulses should be performed only on patients with thick skin with relatively low protrusion levels Do not perform double pulses on frame skin segment...

Page 48: ...Heat Sensation Protrusion Level When performing ablative treatment it is recommended to apply low parameters in the beginning in order to examine the patient s response in terms of comfort level and...

Page 49: ...ation should be performed Clean the distance DG with 70 medical grade alcohol before and after every treatment Routine Treatment The treatments should be at least 4 weeks apart In case of thin sensiti...

Page 50: ...which are not flat such as back of hands gently hold the skin straight in order to flatten it When working below the eyes always maintain safe distance from the eyes apply minimal stretching by hand...

Page 51: ...should not glide on the skin between pulses but contact and then detach from the surface every time In order to prevent any sudden movements it is recommended to provide hand support to the patient t...

Page 52: ...should be closed especially when working near the eyes The periorbital Handpiece is designated especially for use in the periorbital area and or any other hard to reach areas All precautions should b...

Page 53: ...rance It is preferable to apply non perfumed makeup Do not cleanse the patient s skin after treatment It is recommended to apply on irritated sensitive skin an emollient ointment such as Cicalfate by...

Page 54: ...T2 UM E ENG Rev 10 Novoxel com Page 53 Typical Patient Response to Treatment Example 1 Before Treatment Left Immediately After Treatment Right Crusting 3 Days After Treatment on the Right An Enlarged...

Page 55: ...User Manual TXLD0012 Page 54 Novoxel com P N T2 UM E ENG Rev 10 One Month After Treatment...

Page 56: ...User Manual TXLD0012 P N T2 UM E ENG Rev 10 Novoxel com Page 55 Example 2 Before Treatment Left Immediately After Treatment Right Crusting 5 Days After Treatment Left One Month After Treatment Right...

Page 57: ...nt should refrain from working with hot water cleaning materials other materials affecting the skin of the hands without the use of gloves especially when the skin is sensitive and or crusting The pat...

Page 58: ...gin Activate the handpiece when not touching the skin to verify proper operation Expected Possible Complications and Adverse Effects In the same manner as all fractional skin treatment devices there i...

Page 59: ...Hyper pigmentation Hypo pigmentation Sensitivity to sun exposure Local burns Scars Herpes Simplex Local bacterial infection In case of any of the occurrence of any side complication or adverse effect...

Page 60: ...ertified 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 treatment day Cleaning...

Page 61: ...e power cable Clean the device Console and components as previously instructed Disconnect the Handpieces and place them in their designated boxes Place the Console and all components in the Tixel2 dev...

Page 62: ...0 m Activate the Handpiece by pressing the trigger to produce a pulse and visually inspect the Tip s movement along its travel route forth and back The movement should be smooth without any substantia...

Page 63: ...er for servicing Carefully remove the upper cover of the handpiece to make sure that the warranty seal below is not broken When turning on the device listen to the sound of the blower If there is an a...

Page 64: ...uch an environment Emission Test Compliance Electromagnetic Environment Guidance Electrical Spec 100 240 VAC 10 T5A 50 60Hz Up to 300W Group 1 Energy Source Thermal Tip Surface Material Skin contact T...

Page 65: ...8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast t...

Page 66: ...ery Power frequency magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment...

Page 67: ...nications 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 manufac...

Page 68: ...User Manual TXLD0012 P N T2 UM E ENG Rev 10 Novoxel com Page 67 This page intentionally left blank...

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