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User Manual TXLD0012
TABLE OF CONTENTS
Scope .......................................................................................................................................................... 5
Introduction ................................................................................................................................................ 5
This Manual ............................................................................................................................................... 5
Specifications of This Manual ................................................................................................................... 5
Glossary, Conventions, Abbreviations, Signs and Symbols ...................................................................... 6
Glossary ..................................................................................................................................................... 6
Abbreviations ............................................................................................................................................. 7
Signs and Symbols ..................................................................................................................................... 8
Operating State, Location and Position ...................................................................................................... 9
Electrical Safety Information ..................................................................................................................... 9
Electrical Medical Equipment Classification ............................................................................................. 9
Environmental Protection ........................................................................................................................ 11
Applicable Standards ............................................................................................................................... 12
The Tixel2 device – Overview ................................................................................................................. 12
System Layout and Components .............................................................................................................. 13
Principle of Operation and System Components ..................................................................................... 15
The Novoxel® Tip ................................................................................................................................... 15
The Standard Tip ...................................................................................................................................... 15
The Periorbital 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 Touchscreen ................................................................... 26
The Home Screen ..................................................................................................................................... 26
The Operating Screen ............................................................................................................................... 28
Pulse Credit & the Pulse Credit Screen ................................................................................................... 31
Purchasing of Pulse Credit ....................................................................................................................... 31
Entry of Credit Codes via the device’s Pulse Credit Screen - via the Home Screen ............................... 32
The Novoxel Application ......................................................................................................................... 33
System Shutdown ..................................................................................................................................... 34
Tip Cleaning ............................................................................................................................................. 37
Prepare the Following .............................................................................................................................. 37
Tip Cleaning Screen ................................................................................................................................. 37
Tip Sterilization ........................................................................................................................................ 42
Intended Use ............................................................................................................................................ 43
Indication for Use ..................................................................................................................................... 43
Contraindications for Use ........................................................................................................................ 43
Intended User ........................................................................................................................................... 44
Intended Treatment Areas ........................................................................................................................ 44
Pre-Treatment Patient Preparation ........................................................................................................... 44
Patient Pre-Treatment Preparation and Guidance .................................................................................... 44
In-Clinic Pre-Treatment Patient Preparation ............................................................................................ 45
P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 1

TABLE OF CONTENTS
Determination of Treatment Parameters .................................................................................................. 45
First Treatment ......................................................................................................................................... 45
Single Pulse Treatment Characteristics for Caucasian Fitzpatrick I-IV Skin Phototypes ....................... 47
Comfort Level during Treatment ............................................................................................................. 47
Post-Treatment Heat Sensation ................................................................................................................ 47
Protrusion Level ....................................................................................................................................... 47
Device Preparation ................................................................................................................................... 48
Routine Treatment .................................................................................................................................... 48
Criss-Cross Mode ..................................................................................................................................... 49
Frame Segments ....................................................................................................................................... 50
Specific Skin Irregularities: Moles/Open Sores ....................................................................................... 52
Post-Treatment ......................................................................................................................................... 52
Typical Patient Response to Treatment ................................................................................................... 53
Example # 1 ............................................................................................................................................. 53
Example # 2 ............................................................................................................................................. 55
Post-Treatment Patient Guidance ............................................................................................................. 56
Safety Guidelines ..................................................................................................................................... 56
General Safety: Supervising Physician .................................................................................................... 56
Warnings and Precautions: Patient & Operator Routine Operation Safety ............................................. 56
Expected Possible Complications and Adverse Effects ........................................................................... 57
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 ............................................................................. 61
Essential Performance .............................................................................................................................. 63
Electromagnetic Emissions & Immunity ................................................................................................. 63
Recommended Separation Distances between Portable and Mobile RF Communications
Equipment and the Device ....................................................................................................................... 66
BLE Module with Chip Antenna Manufactured by Laird, Model BL652-SA ........................................ 66

COPYRIGHTS AND DECLARATION

All Copyrights are reserved to Novoxel®. Novoxel® reserves the right to modify the Tixel2 device’s
technical specifications and/or its labeling without prior notice. The guidance information in this document
is considered by Novoxel® to be accurate and adequate. Novoxel® is a registered trademark, which is
protected by law. In addition, Novoxel® owns patents and pending patent applications, trademarks,
copyrights, or other intellectual property rights, which are discussed or referred in this document.
Receiving an authorized copy of this manual does not provide any permission, license or consent to
perform any use of this aforementioned intellectual property, unless otherwise declared by Novoxel® in a
specific written approval. This manual is part of Novoxel’s intellectual property and is intended for
informational use only. This manual may not be reproduced, transmitted, copied, printed, displayed and/
or distributed in any form, media or means, electronic or mechanical, for any purpose, without specific
prior written consent of Novoxel®.
BEFORE YOU BEGIN
The Responsibility for use of the Tixel2 device lies solemnly on its operator. By paying proper attention
to all safety information, you will be able to prevent injuries and product damage. It is within 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 document or others
are disregarded. In such case, Novoxel will assume no responsibility for such use of the product. All
procedures must be performed only after following Novoxel’s training policy, fully reading this manual
and proper familiarization with all safety and operation guidelines of the device, regulations, including all
applicable local or national safety regulations and rules for the prevention of accidents which must be
observed in all work places. The operator of the device must be familiar with the practical principles of
skin rejuvenation principles in general and fractional skin treatment in particular. The operator must
comply with all the guidelines, warnings and precautions portrayed in this document. Full compliance with
all local laws and regulations is obligatory for use of the device. 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. It is imperative to stop the operation
of the device immediately in case of detection of any malfunction.
NOTE: The approved CE medical indication by Novoxel’s NB is Actinic Keratosis (refer to page 43).

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Page | 4 Novoxel.com P/N T2-UM-E-ENG Rev 10

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.
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
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
This Manual’s Specifications

Glossary, Conventions, Abbreviations, Signs and Symbols
Glossary
Term Definition
A metallic element, permanently mounted on the Handpiece of the
device, which performs the interaction with the treated tissue.
The Novoxel® Tip, or “Tip”
Several configurations/sizes exist, see description further down
this document.
A handheld apparatus, which is used by the operator to perform
The Tixel2 Handpiece
treatments. The Handpiece contains the Novoxel® Tip.
A back and forth motion of the Tip extending it towards the tissue
to be treated. A pulse is performed by pressing the Handpiece
trigger. A treatment is typically comprised of multiple pulses on
Pulse and Pulse Credit adjacent areas. The length of the 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 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
Single/ Double Pulse Mode
Handpiece may result in either one or two pulses, depending on
user selection.
Overlapping Performing more than one pulse on the skin at the same location.
Performing two pulses on the same location but at a different
“Criss-Cross” Handpiece and Tip orientation. Further details, are available in the
operation segment of this manual.
The relative distance which the Tip’s vertices protrude beyond the
distance gauge’s distal end of the Handpiece towards the treated
Protrusion
tissue when a pulse is performed. The protrusion distance is
controlled by the Tixel2 device’s Graphic User Interface (or GUI).
Glossary

Abbreviations
Abbreviation Definition
The technology platform powering the Tixel2 device is named
Thermo-Mechanical Action (or TMA). The principle of operation
TMA
is described further down this manual. For further information
regarding this technology, refer to our website: www.Novoxel.com
HP The Tixel2 Handpieces or any other applicable Handpiece.
The Handpiece’s Distance Gauge, see description further down
DG
this document.
Abbreviations

Signs and Symbols
Symbol Meaning
Manufacturer
Manufacturing Date
SN Serial Number
Batch Code
EC REP Authorized EC Representative.
Caution; Consult accompanying documents.
CE mark (Medical)
XXXX
Type B applied part (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 damage to

the product.
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.

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
unsuitable for this purpose.
 Do not place the product on a heat-generating surface or near heat emitting devices such as heaters.
Verify that there is sufficient clearance between the product and any other system that may exhaust
heat.
 The product is for indoor use only.
 General Operating Conditions:
The product’s operating ambient range is temperature of 10 to 30°C (50 to 86 °F) and relative humidity of
20-80%. 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 longer MTBF of the equipment. The temperature must not exceed the maximum temperature specified
above.
 Maximum operating altitude: 1000 m ASL (~3,300 ft.).
 Maximum transport altitude: 4500 m ASL (~15,000 ft.).
Electrical Safety Information
Electrical Medical Equipment Classification
Equipment Classification: Class I

Equipment Type: B
Safety Fuse: Ceramic, T5A, 5×20 mm, Littelfuse Inc.

The following information on electrical safety must be observed, as failing to follow these instructions
may result in electric shock, fire and/or in serious personal injury or death.
 Prior to switching the product on, always ensure that the nominal voltage settings of the product match
the nominal voltage of the AC supply network.
 This product should be connected to the power mains using a 3-wire (two conductors and ground)
power cable and plug, complying with local regulations. Use this power cable with a properly
grounded electrical outlet to avoid electrical shock.
 If extension cords or connector strips are implemented, they must be checked on a regular basis to
ensure that they are intact, positioned safely and safe to use.
 The plug of the connecting cable is regarded as the disconnecting device. In such cases, always ensure
that the power plug is easily reachable and accessible at all times (corresponding to the length of
connecting cable, approx. 2 m).
 Never use the product if the power 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 that the cable will not be damaged and that no one can be hurt
by, for example, tripping over the cable or suffering an electric shock.
 Do not insert the plug into sockets that are dusty or dirty. Insert the plug firmly and all the way into
the socket. Otherwise, sparks that result in fire and/or injuries may occur.
 Do not overload any sockets, extension cords or connector strips; doing so can cause fire or electric
shocks.
 Never remove the cover or any part of the housing. Doing so will expose circuits and components and
can lead to injuries, fire or damage to the product.
 Use suitable over-voltage protection to ensure that no over-voltage (such as that caused by a bolt of
lightning) can reach the product. Otherwise, the person operating the product will be exposed to the
danger of electric shock.
 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.

 Never use the product under conditions in which condensation has formed or can form in or on the
product, e.g. if the product has been moved from a cold to a warm environment. Penetration by water
or other types of liquids increases the risk of electric shock.
 Prior to cleaning the product, disconnect it completely from the power supply. Use a soft, non-lint
cloth to clean the product, as instructed.
 Prior to service procedures or replacement of any parts of the device, disconnect 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 into the openings designated for Tip replacement or air ventilation.
 Never leave the system unattended in “Operate” mode.
Environmental Protection1
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.
1. WEEE = Waste Electrical and Electronic Equipment

Applicable Standards
 The European Council Medical Device Directive 93/42/EEC.
 EN 60335-2-23:2003 + A1:2008 + A11:2010.
 IEC 60335-2-23:2003 (Fifth edition) (incl. corr.2:2008) + A1:2008.
 + A2:2012, in conjunction with EN 60335-1:2012 (Fifth edition)3.
 IEC 60335-1:2010 (Fifth edition).
 IEC 60601
 EN 55014-1: 2006 + A1:2009 + A2:2011.
 EN 61000-3-2: 2006 + A1:2009 + A2:2009.
 EN 61000-3-3: 2008, EN 55014-2: 1997 + A1:2001 + A2:2008 + IS1:2007.
 The EMC Directive 2004/108/EC, Category IV Standards, harmonized under article 6(2).
 SOR-98-282: 2014, Canadian Medical Device Regulations.
 The WEEE Directive 2012/19/EU, Management of Electronic 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 ablative micropores or non-ablative coagulative sites
on the treated tissue. The fractionated thermal effect on the treated tissue is created by brief direct contact
of the 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.
Tixel2 is designated for use in professional healthcare facility environment only.

System Layout and Components

The Tixel2 device’s general layout and components are displayed in figure below.
The Tixel2 Device

3.1 2 1 3.2
4.1 4.2
5.1 5.2
6.1 6.2
7
The Tixel2 Components
The main components of the Tixel2 are specified in the following table:
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 connectors (left and right, respectively).
6.1, 6.2 Handpiece umbilical cable (left and right, respectively).
7 Tixel2 Console decorative LED lighting.
List of Tixel2 Components

Principle of Operation and System Components

The Tixel2 Handpieces (or the “Handpiece/s”) are used to perform the treatment. Each HP is plugged into
the Console, which controls the system. The Novoxel® Tip is mounted on each HP. The Tip is reusable.
However, after each treatment session, the Tip must be cleaned and sterilized according to the instructions
in this document.
At any given point, only one HP can be applied to perform treatment. However, the other HP can remain
available by being kept hot (for a limited amount of time).
When the HP is activated (by pressing the trigger), a pulse will occur, as follows:
 The HP moves the Tip through the distance gauge towards the skin (protrusion distance is modifiable).
 The Tip comes in brief contact with the skin for a precisely controlled pulse duration (selected by the
user from a predefined number of options, depending on patient characteristics and desired effect).
 The Tip is retracted back to its baseline 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 mode.
The Novoxel® Tip
Two Tip configurations exist, the standard and the periorbital, which differ only by the size of the treatment
surface. All safety precautions and instructions for use apply in the same manner for both configurations.
The Standard Tip

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). In operation, the Tip’s temperature is maintained at a working temperature of ~400°C and
its active area (the area containing the matrix of pyramids) is ~1 cm².
The Tip has a limited product life and may be used only for a pre-determined number of pulses. The Tip’s
life duration is determined by the Handpiece’s life duration.

Tip€31
s Treatment
Surface
Standard Novoxel® Tip
The Periorbital Tip

The second configuration of the Tip is the periorbital Tip. It is made of the same materials and is designated
for treatment of hard-to-reach locations, such as the periorbital area. It has the same design as the standard
Tip, except for its size: the treatment surface 6 × 4 pyramids (24 in total) and its active area (the area of
the matrix of pyramids) is 0.3 cm².
Tip Description -General Specifications and Operating Parameters

Size (Height, Length, Width -  Standard: H 6.5mm X L15mm X W15mm
approximated)  Periorbital: H 13mm X L15mm X W15mm
Working temperature 400°C (+5°C/-15°C)
Hibernation temperature 200°C (±5°C)
 5-18 milliseconds (±1millisecond)
Pulse duration  (Possible durations: 5,6,8,10,12,14,16,18;
 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
Initial complimentary pulse 25,000 for any new Tixel2 device HP (regard-less of Handpiece and Tip
credit types)
Novoxel® Tips Specifications

 A New Tip is pre-mounted on the Handpiece. It is clean and requires only minor
processing. For instructions, refer to the Tip cleaning instructions in Chapter 7 of
this document.
 All information provided 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 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.

The Tixel2 Console
The Tixel2 Console contains:
The Tixel2 Console
 A touch-screen control unit.
 Cradles for resting the Handpieces.
 Two inlets for the 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 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
drawing air through its tubing by the Console’s blower.

Two Handpiece configurations exist: Standard and Periorbital. These are in fact identical Handpiece
designs, which differ only by: Tip configuration and Distance Gauge configuration (see further
information below regarding the 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.
 Tip heating element.
 A Distance Gauge (or DG):
The Distance Gauge is attached to the Handpiece on its distal end by magnets. The tip is pushed forward
and backwards through it during the treatment pulse. The DG is placed on the patient’s skin at the desired
location for treatment prior to a pulse. The Distance Gauge also functions as a safety precaution by
securing the operator and the patient from exposure to the hot Tip and to the heating unit. The DG can be
manually removed for cleaning of the Tip and for cleaning of the DG itself.

The HP contains a LED light in order to illuminate the treatment area.

When activated 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 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.

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.
The contents of the package is described in the following table:
Item # Description Quantity

1 HandpieceTixel2 Console x1
2 HP Cradle x2
3 Standard Tixel2 Handpiece x1
4 Periorbital Tixel2 Handpiece x1
5 This User Manual x1
6 Power Cable x1
The packed product may be heavy and should be handled with care. The system
installer may require suitable means of lifting and/or moving the product to avoid
physical injury.
The handles on the product packaging are designed exclusively to enable personnel to
transport the product. It is therefore not permissible to use the handles to fasten the
product to or on transport equipment or vehicle. The user is responsible for securely
fastening the products to the means of transport or lifting or on any of them.
Handpiece/s Receiving Inspection – Content and Functionality Verification
Visually inspect (bare eye examination) the Novoxel® Tips on any Handpiece prior to first operation to
verify that:
 The vertices of the pyramids are uniform and intact.
 The Tip is clean and unscratched.

 The Tip is centered in relation to the Distance Gauge when the Tip passes through it.
In case of any fault, contact your vendor.

Installation
The Handpiece cradles 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 convenience, but always make sure it is firmly held in the Console.
Connecting the Handpiece Cradles

Place each Handpiece 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, twists
or pinches.
 It is allowed to operate the device using a single Handpiece.

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:
The Handpiece Connector Inlets in the Console (Left) and the Handpiece Cable Connector (Right)
Plugging the Tixel2 Handpieces into the Tixel2 Console

Also, note the black insertion indication, which should be adjacent to the inlet’s edge.
Connecting the Handpiece to the Console [The Handpiece Connector in the image may differ from the one that you have]
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’s electrical safety guidelines and technical specifications).
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.

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.
The Home Screen

After System check has been completed, the Home screen will be displayed:
Home Screen

Term Description
Navigation to the Operate Screen by Handpiece selection. By pressing on the icon, the
Operate Screen will be displayed after heating and sterilization of the selected Handpiece.
1.1 The other Handpiece will be heated to a hibernation temperature of 200°C during the
process.
1.2 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 color
index table below).
2 Initiate the Tip cleaning process.
3 Decorative blue LED control (On/Off).
4 Demo Mode
5.1 Temperature indication, cord to the next color index:
Ready to work: Red 385-400°; Orange 200-384°; Yellow 80-199°; Blue 0-79°
5.2 Note: the accuracy of the temperature measurement is ±5° Celsius.
6 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

When the Handpiece expires, after 250,000 pulses, the following notification screen will be displayed until
a new Handpiece is connected:
The Left and Right Handpiece Expiration Notification Screens
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.
The Operating Screen

The Operating screen allows selection of the desired Handpiece and treatment parameters.
Operating Screen

Item # Description
The Handpiece which was pre-selected in the Home screen, will be heated to
working temperature (400°C) and sterilized. When heated the icon will become
orange and blink.
The selected Handpiece shall be indicated by the red dot in the following icon:
When Handpiece temperature have reached 385°C and sterilized, the icon will
become green, and 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.
Note: The other Handpiece will remain at hibernation temperature (200°C) indicated
by an orange icon.
1.1 Preparing the Second Handpiece for Operation

Press on the hibernated Handpiece icon. The second Handpiece will be heated to
1.2
working temperature and sterilized for 1:00 minute. During the heating process, the
icon will become orange and blink.
After the sterilization process has been completed, the second Handpiece will have a
blinking green icon but without the red dot.
Switching between Handpieces

Press on the icon of the second Handpiece. The Handpiece icon will have a red dot,
as demonstrated below:
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.

Note: When both Handpieces are active (indicated by a green icon), switching
between them may be performed instantly. The non-active Handpiece will be
indicated by a blinking green icon.
Automatic Hibernation/End of Session

1.1 The active Handpiece/Handpieces will remain heated for 20 minutes after the last
pulse has been performed. After this time, it/they will be automatically cooled down
1.2 to hibernation temperature (200°C).
After 10 further idle minutes, the treatment session will be automatically stopped and
(Continued) the Home screen will be displayed.
Notes:
 Any activation after hibernation will require re-sterilization.
 Any activation after end of session will require re-sterilization, unless the
Handpieces remain in working temperature.
2 Indication of the selected Handpiece.
3 End of session and return to the Home screen.
Selection/De-selection of the “Double Pulse” option. This option will be displayed
4 for pulse durations of 8-16 milliseconds only. When selected, the icon will become
orange.
Pulse duration. Varies between 5-18 milliseconds. The increase/decrease is by
intervals of 2 milliseconds, except for a 1 millisecond gap between the 5-6 options.
5 Treat only after establishing adequate parameters. Not every
parameter setting is suitable for every patient. See clinical
information and guidelines for further information.
6 Protrusion. Varies between 100-1,000 microns, in 100 micron intervals.
Temperature indication, cord to the next color index:
Ready to work: Red 385-400°; Orange 200-384°; Yellow 80-199°; Blue 0-79°.
7.1
Handpiece heating will be indicated by a small upward arrow icon (˄) located above
7.2
the Handpiece temperature indication. Handpiece cooling will be indicated by a
small downward arrow (˅).

Pulse Credit counter. The counter is device specific and does not take into account
which Handpiece is used. The remaining credit is also indicated by color: Green for
up to remaining 2,500 pulses; Yellow for remaining 1,000-2,499 pulses, Blinking
Red for less than 1,000 remaining pulses.
8
For further details on pulse credit, go to the section named Pulse Credit (below) and
the Pulse Credit screen.
9 Current session pulse counter.
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. It is possible to renew your pulse credit at any given time, regardless if it has been exhausted
or not. Updating of the credit is performed by entry of purchased credit codes, to the dedicated code entry
screen on the device or by using a dedicated application, as follows:
Purchasing of Pulse 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 device for which you
would like to purchase the credit (stated on the label of the device). Once the purchase has been complete,
you will receive a message with the designated code.

Entry of Credit Codes via the device’s Pulse Credit Screen - via the Home Screen.
The code is device-specific and cannot be transferred between devices.
Press and hold for four

seconds on the high-
lighted area.
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.
The following screen will be displayed:
Pulse Credit Code Screen

Enter the code in the designated field.
 In case the pulse credit of the system has expired, the pulse credit screen will be
displayed automatically, and access to the Operate screen will be disabled.
 Entry of a wrong code will be indicated by the letter “E” in the entry field.
 Entry of 5 wrong codes will lock the device for 24 hours.
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.

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.

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. When heated the icon will become orange and blink.
The selected Handpiece shall be indicated by the red dot in the following icon:
When Handpiece temperature have reached 385°C and sterilized, the icon will become
green, and 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.
Note: The other Handpiece will remain at hibernation temperature (200°C) indicated by
an orange icon.
1.1
Preparing the Second Handpiece for Operation
1.2 Press on the hibernated Handpiece icon. The second Handpiece will be heated to working
temperature and sterilized for 1:00 minute. During the heating process, the icon will
become orange and blink.
After the sterilization process has been completed, the second Handpiece will have a
blinking green icon but without the red dot.
Switching between Handpieces

Press on the icon of the second Handpiece. The Handpiece icon will have a red dot, as
demonstrated below:
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.
“X” stands for either 1) signifying the left Handpiece or 2) signifying the right Handpiece.

Displayed Screen Comments
This safety warning is displayed when the

Distance Gauge has been removed and the Tip is heated to high
temperatures. The notification will be eliminated only when the DG
is reconnected. In case the Distance Gauge has been removed, hold
the Handpiece carefully to avoid injury. Connect the DG to
proceed.
Do not remove the DG during an ongoing treatment session.
The Handpiece has expired. Connect a new Handpiece. In case 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 require the

operator to contact service:
E-01X1 Handpiece Motion failure, please shut down, restart and try
again. If error persists call service.
E-02X1 Handpiece heating failure, please shut down, restart and try
again. If error persists call service.
E-03X1 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.

Chapter 6: Caring For the Tips
Tip Cleaning
All device components cleaning should be performed using disposable gloves.
Prepare the Following:
 A receptacle with Analytical Grade IPA (Isopropyl Alcohol; Propan-2-ol AR, 91% or higher).
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).
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 the Tip for cleaning by either heating up to at least 80˚C
or cooling down below 200˚C. The following screen will be displayed:
Adjusting Tip temperature for Cleaning (Heating or Cooling, as Required)

When the desired temperature has 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 be displayed, instructing you to remove the Handpiece’s DG.
Remove the Handpiece’s Distance Gauge

This step should be performed as follows:
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. 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.
Removal of the Handpiece’s Distance Gauge

The Cleaning Process: Once the DG has been removed, the following 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 the brush and brush the Tip for 30 seconds at least, until visibly clean, as demonstrated
below:
Correct Brushing of the Tip

 After tip cleaning, clean the toothbrush using the medical grade Alcohol.
 After cleaning the Tip, place the Handpiece in its cradle, without the DG. Soak a fiber-less wipe or
gauze in the medical grade Alcohol (70%) in order to clean the Distance Gauge thoroughly. Cleaning
should be performed using disposable gloves.
 Return the DG to the Handpiece.
 Heat cleaning of the selected Handpiece will now automatically commence. The process is 6:00
minutes long.
 You may now select to perform cleaning of the second Handpiece as well. A countdown of 30 seconds
will be displayed, in which you may add the second Handpiece to the cleaning process by pressing on
its icon. If selected, you will then be requested to repeat the cleaning steps. The system will complete
the cleaning procedure by heating the Tip/s for the selected Handpiece/s.
 If the second Handpiece was not selected, the heat cleaning process will continue to complete the
process.
Returning to the Home screen will stop the cleaning process.
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.

Tip Sterilization
Sterilization of the Novoxel® Tip shall be automatically performed before the system enables operation.
The Tixel2 device performs automated dry-heat sterilization. The process is performed after selection of
working parameters by 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 has been completed and the device is ready.
The Cleaning process described above should be performed prior to your navigation to the “Operate”
screen. Sterilization will be performed as part of the “Operate” screen process.
When performing sterilization, the following screen will be displayed:
The Sterilization Screen

Chapter 7: Clinical Information and Guidelines
Intended Use
Dermatological procedures requiring ablative and/or non-ablative treatment of the skin. It is indicated for
use on human skin treatments.
Indication for Use

Treatment of Actinic Keratosis.
Contraindications for Use

 Note: These mentioned contra-indications should be evaluated prior to every treatment session and
not only prior to the entire treatment series.
 The device is contra-indicated for use on patients who demonstrate the following conditions:
 Any patient who has undergone tanning during the 4 weeks prior to any treatment session and/or any
patient who plans to undergo tanning during the 4 weeks following any treatment session [patients
who may 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 pre-malignant lesions or moles in the treatment
area.
 Any female who is pregnant or plans to become pregnant during the treatment period, or is currently
breastfeeding.
 An impaired immune system condition or use of immunosuppressive medication.
 Collagen disorders, keloid formation and/or abnormal wound healing.
 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
treatment (oral or topic), food supplements or vitamins, which may cause fragile skin or impaired skin
healing during the last 3 months.

 Any patient who has used oral Isotretinoin (Accutane® or Roaccutane®) within 3 months prior to
treatment or less.
 Any patient who has a history of bleeding coagulopathies or use of anticoagulants.
 Any patient who has tattoos or permanent makeup in the treated area.
 Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to
be treated.
 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

Any treatment area, which 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 hemorrhage, bleeding, rash, psoriasis, eczema and/or dry and/or
fragile skin and/or any other abnormal skin condition.
Do not treat genital areas. All treatment areas must be treated with adequate settings (see below).
Pre-Treatment Patient Preparation
Patient Pre-Treatment Preparation and Guidance
 Any caregiver contact with the patient should be performed using disposable gloves.
 It is recommended that a physician examine the patient prior to every treatment session.
 Instruct the patient not to tan for 4 weeks prior to treatment. In case the patient has to be exposed to
sun for short periods, she/he must apply a high SPF sunscreen, of at least 50.
 Patients with a history of Herpes Simplex may be prescribed prophylactic drugs cord to the
physician’s discretion.

In-Clinic Pre-Treatment Patient Preparation
 Perform pre-treatment examination to verify the patient has not recently become contraindicated for
treatment.
 The treatment may commence only after the patient’s skin has been thoroughly cleaned, cord to the
following instructions:
 It is recommended to clean the treatment areas with soap and commercial grade distilled water/
thermal water. Remove all makeup, mascara clumps and/or any other materials, which may be on the
patient’s skin.
 Use only non-woven fiber-less wipes.
 If the patient’s eyelashes and/or eyebrows are covered with mascara, either remove it or brush the
covered area in order to avoid mascara clumps during treatment.
 Spray commercial grade distilled water/ thermal water on the treatment areas. Tap water 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 Treatment
 Tolerability Test: It is advised to perform a tolerability test prior to commencement of the first
treatment. Select a soft, non-frame, hairless segment and perform three non-overlapping pulses with
a protrusion level of 200 microns. Evaluate the patient’s response prior to treatment.
 The first treatment should be performed with relatively low density of pulses, and mild treatment
intensity parameters (in terms of pulse duration and protrusion levels), lower than the maximum
parameters described in the parameter table further below this document. It is also recommended to
avoid double pulses, multiple passes and criss-cross pulses during the first treatment session. In
following treatment sessions, higher intensity may be reached gradually cord to the patient’s response,
treatment tolerance and physician’s discretion.

 Single vs. Double Pulse Mode: The maximum single pulse duration recommended for Caucasian
skin treatment is 16 milliseconds. For double pulse duration, the maximum recommended pulse
duration is 10 milliseconds. Do not apply double pulses during a patient’s first treatment session.
Double pulses should be performed only on patients with thick skin, with relatively
low protrusion levels. Do not perform double pulses on frame skin segments (see
below).
 Protrusion: The Protrusion level of the Tip should normally not exceed 500 microns. However,
increase of protrusion can be done cord to the physician’s discretion.
 It is recommended that treatment parameters such as pulse duration and level of protrusion be
determined by the supervising physician, cord to the following treatment intensity recommendations
table:
Suggested Treatment Parameters
Caucasian Skin Other Ethnicities /

Treatment Skin Types I - VI Skin Typesb
Segment Type
Objective Thickness a Pulse Protrusion Pulse Protrusion
Duration [ms] [microns] Duration [ms] [microns]
Acne Frame Normal 10 400 10 300
Keratosis
Soft Normal 12 400 12 300
1st Treatmentc
Acne Frame Normal 10 400 10 300
Keratosis
Subsequent
Treatments Soft Normal 12 400 12 400
(at least 3)d
a. 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.

Single Pulse Treatment Characteristics for Caucasian Fitzpatrick I-IV Skin Phototypes
Comfort Level during Treatment
* Analgesic creams are not required. Comfort level is typically not dependent on skin phototype.
Post-Treatment 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 heat sensation. Intensification
of the treatment’s parameters should be performed gradually.
 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.

Further considerations, which apply when determining treatment intensity parameters:
 The patient’s comfort level in previous treatments and after them.
 The patient has an observed skin response (erythema, inflammation, etc.).
Device Preparation
 Prior to treatment, Tip cleaning and automatic sterilization should be performed.
 Clean the distance DG with 70% medical grade alcohol before and after every treatment.
Routine Treatment
The caregiver performing the treatment should always wear disposable gloves during
treatment.
 The treatments should be at least 4 weeks apart. In case of thin/sensitive skin, consider longer healing
periods between treatment sessions.
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.

Criss-Cross Mode
Consider working in Criss-Cross mode in deeply wrinkled segments. In this technique, the pulses (single
pulse mode only) are performed in the same location but not in the same orientation, as depicted in the
following figure:
“Criss-Cross” Pulse Mode
 Criss-Cross may be performed only in Single pulse mode and by applying

relatively moderate parameters.
 It is recommended that the treatment be performed with the patient lying down.
 It is important to treat only flattened skin segments, in order to avoid skin

pinching, especially in thin skin patients.
 In addition, do not overstretch the patient’s skin during treatment. In case of treatment of loose skin
areas, or areas 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 in order to avoid skin folding.
 Position the Handpiece perpendicularly to the skin prior to activation, as demonstrated in the
following figure:

Proper Positioning of the Tixel2 HP on the Skin
 In case the perpendicular positioning of the Handpiece is not possible, do not treat the specific
location.
 Do not apply excessive Handpiece pressure on the skin. The Handpiece should be positioned on the
skin but not pressed against it.
 Stop applying pressure between pulses, in order to allow proper ventilation. The distance gauge
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
(the hand that does not hold the Tixel2 Handpiece).
 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. The facial
segments are demonstrated in the following figure:

Boney Facial
Treatment Areas
Diagram of Boney Facial Segments
 Do not treat in proximity to eyes/ears/nostrils/lips/eyebrows/below eyebrows.
 During facial treatments, the patient’s eyes 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 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.

Specific Skin Irregularities: Moles/Open Sores
Do not treat.
Post-Treatment
 If treated with a pulse duration of more than 10 milliseconds or a double pulse, do not apply makeup
for at least 48 hours after treatment. It is generally advised not to apply any makeup prior to soothing
of the face and crust disappearance. 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

Avène, Cicactive by Uriage, Cicabio by Bioderma, Cicaplast by La Roche Posay, etc. It is
recommended to perform a tolerability test prior to application of the material on the skin.
 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.

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

One Month After Treatment

Example # 2
Before Treatment (Left) / Immediately After Treatment (Right)
Crusting, 5 Days After Treatment (Left) / One Month After Treatment (Right)

Post-Treatment Patient Guidance

 It is not recommended to apply moisturizing creams after treatments.
 The patient should be notified that the treated skin segments might become red for a few days, and
feel hot, even up to a burning sensation, for a few hours. Tightening of the skin may also be
experienced. It is recommended to apply any of the ointments mentioned above (see segment 7.10 –
Post Treatment), a few times daily for up to 8 days.
 The patient should not tan for at least 4 weeks before and after treatment. In case the patient has to be
exposed to the sun for short periods, she/he must apply a high SPF sunscreen, of at least 50. Crusted
skin should not be exposed to sun at all.
 In case back of hands treatment has been performed, the patient 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 patient should refrain for at least a week, after each treatment, from the following:
 Any sport, especially swimming and/or any other activity involving sweating.
 Exposure to heat (by sauna, hot showers, etc.).
 Exposure to chemical substances (such as direct exposure of the skin to cleaning

substances)
 Exposure to dust and airborne dirt.
 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. It is possible to demonstrate
the operation of the device by using the Demo Mode.

 The operator should read this manual and its clinical guidelines in particular.
 The operator should always be mindful of the fact that The Tip is hot during treatment.
 When not in use, always place the Handpiece in its cradle.
 Do not cover the DG or insert any item/fingers into it.
 NEVER TOUCH THE TIP WHILE HOT.
 The Tip should be cleaned prior to each treatment session.
 As in all fractional skin treatment devices, treatment with the Tixel2 device may
pose a risk of dermal injury. The risk increases as treatment parameters are
intensified: exposure time (pulse duration) and pulse repetition (double pulse
mode in comparison to single pulse mode). Follow all clinical guidelines in this
document in order to ensure selection of the most suitable treatment parameters
for the patient.
 Visually inspect the Tip prior to use. Do not use defective Tip and/or any other device components.
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® Tip do not contain or incorporate any medicinal substances and/
or any materials of biological origin.
 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 is some risk of:
 Temporary swelling longer than a few hours, which does not recover without treatment.
 Skin redness longer than two weeks.
 Pain or burning sensation longer than a few hours and/or is not tolerable.
 Forming of large scabs or scabs lasting more than 15 days.
 Significant/thick skin peeling or any peeling lasting more than 2 weeks.

 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, it is imperative to consult
a physician within a short period.

Chapter 8: Maintenance, Service and Storage
Maintenance
The system does not require any specific maintenance except for a monthly visual inspection to verify that
the Console, the other components and the cables, are not damaged in any way.
In case of any detected damage, stop treatment immediately and contact your vendor.
Damaged and/or dirty equipment should not be used at all.
Product Lifetime
Product lifetime shall be 3 years after starting using the product but not more than 3.5 years after product
delivery to the customer. The Handpieces and the Tips shall be used for 250,000 pulses (assuming
approximately 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
treatment day. Cleaning should always be done using disposable gloves.
 Prior to cleaning the product, shut it down and disconnect it from the power supply.
The device and the Handpieces and/or cables, should be cleaned after treatment using
a wipe soaked lightly with Ethanol 70% (see cleaning instructions below) and the Tip.
Cleaning the Tixel2 Handpiece Distance Gauge (the DG)
Remove the DG for cleaning purposes only, after the Tip has cooled down below
200°C.
 Place the Handpiece in the console’s cradle.
 Clean the distance DG with 70% medical grade alcohol before and after every treatment.

 Use only unwoven fiber-less wipes.
 Reconnect the DG to the Handpiece.
 Cleaning the Novoxel® Tip - see Chapter 6: Caring For the Tips.
Storage and Packaging
Device Storage
 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.
 For long-term storage or for shipment purposes, follow the next step prior to returning the Tixel2
device to its original packaging:
 Disconnect the 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 device’s designated box / bag.
 Close the box.
For more information regarding boxing and shipment, contact your vendor.
Disposal
The disposal of the Tixel2 device and its accessories should be performed cord to WEEE directive 2012/
19/EU. In case you wish to dispose of the Handpiece and/or the Console, ship them back to Novoxel/ your
vendor.
Periodic Inspection & Service Instructions
The following instructions should be carried out by a trained operator of the device.
In general, the system does not require any special service other than cleaning and visual inspection.
However, certain inspections should be performed periodically as described herein.

Annual Inspection by Certified Local Representative
Prior to activating the Handpiece, always check your surroundings to ensure safe
operation of the device. Always point the Handpiece away from yourself when
inspecting its action and integrity.
 Visually inspect the system’s integrity. Verify that all the system components are well secured intact.
In case the components are damaged, the device should not be operated and delivered immediately to
a certified service provider for servicing.
 Visually inspect the power cable for any damage.
 Inspect the Tip for cleanliness. In case the Tip is not clean, perform the cleaning procedure as
described in this document.
 Activate the system, to verify that the software functions normally.
 Set system parameters to 6ms × 600 µm. 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 substantial mechanical sound.
 Repeat the test at 16ms × 800 µm.
 Inspect the Tip’s orientation within the Handpiece. Activate the system. Verify that the Tip moves
freely inside the lumen of the Distance Gauge during a pulse. The Tip should be centered. Slight
deviation from the 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.

 Check the integrity of the Handpiece’s and its connection to the console.
 An audible “click” must be heard upon insertion of the connector to its inlet in the console.
 In any case of malfunction or any abnormality, the device and/or Handpiece should be delivered to a
certified service provider 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 abnormal noise or no sound
at all, the system should not be operated. Deliver it to a certified service provider for servicing.
 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.

Chapter 9: General Guidance and Manufacturer’s Declaration: Essential

Performance & Electromagnetic Emissions & Immunity
Essential Performance
Temperature range shall vary between 385 and 405ºC.
Electromagnetic Emissions & Immunity

The medical device requires specific precautions regarding EMC and needs to be installed and put into
service cord to the 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.
Emission Test Compliance Electromagnetic Environment - Guidance

100-240 VAC ±
10%
Electrical Spec. T5A Group 1 -
50/60Hz
Up to 300W
Energy Source Thermal
Tip Surface Material (Skin contact) Titanium
Console Weight 5400 gr
Handpiece Weight 330 gr
Total Device Weight 6100 gr
System Dimensions 26 L × 30 W × 31 H cm
Packaging Dimensions 57 L × 38 W × 44 H cm
RF emissions Group 1 The device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
CISPR 11 Class B cause any interference in nearby electronic equipment.
Harmonic
emissions Class B
IEC 61000-3-2 The device is suitable for use in all establishments, including
domestic establishments and those directly connected to the
Voltage public low-voltage power supply network that supplies
fluctuations/flicker buildings used for domestic purposes.
Complies
emissions
IEC 61000-3-3

 Use of this device adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this device
and the other equipment should be observed to verify that they are operating
normally.
 The use of accessories other than those specified for the device is prohibited. They
may result in increased electromagnetic emissions or decreased electromagnetic
immunity of the device.
The device is intended for use in the electromagnetic environment specified below. The operator of the
device should assure that the device is used in such an environment.
Electromagnetic Environment -
Immunity Test IEC 60601 Level Compliance Level
Guidance
Floors should be wood, concrete or
Electrostatic
8 kV contact 8 kV contact ceramic tile. If floors are covered with
discharge (ESD),
15 kV air 15 kV air synthetic material, the relative humidity
IEC 61000-4-2
should be at least 30%.
2 kV for power
Electrical fast
supply lines 2 kV for power
transient/burst, Mains power quality should be that of a
1 kV for SIP/SOP supply lines
IEC 61000-4-4 typical commercial or hospital
lines
environment.
Surge, 1 kV line to line 1 kV line to line
IEC 61000-4-5 2 kV line to earth 2 kV line to earth
0% UT for 0.5 0% UT for 0.5
cycle cycle Mains power quality should be that of a
typical commercial or hospital
Voltage dips and
0% UT for 1 cycle 0% UT for 1 cycle environment. If the user of the equipment
interruptions on
requires continued operation during
power supply input
70% UT for 25/30 70% UT for 25/30 power mains interruptions, it is
lines
cycles cycles recommended that the equipment be
IEC 61000-4-11
powered from an uninterruptible power
0% UT for 250/ 0% UT for 250/300 supply or a battery.
300 cycles cycles

Electromagnetic Environment -
Guidance
0% UT for 0.5 0% UT for 0.5
cycle cycle Mains power quality should be that of a
typical commercial or hospital
Voltage dips and
0% UT for 1 cycle 0% UT for 1 cycle environment. If the user of the equipment
interruptions on
requires continued operation during
power supply input
70% UT for 25/30 70% UT for 25/30 power mains interruptions, it is
lines
cycles cycles recommended that the equipment be
IEC 61000-4-11
powered from an uninterruptible power
0% UT for 250/ 0% UT for 250/300 supply or a battery.
300 cycles cycles
Power frequency magnetic fields should
Power frequency
be at levels characteristic of a typical
magnetic field, 30 A/m 30 A/m
location in a typical commercial or
IEC 61000-4-8
hospital environment.

3 Vrms
150 kHz to 80 MHz
6 Vrms in ISM bands (6.765 MHz to 6.795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz to
27.283 MHz; and 40.66 MHz to 40.70 MHz) and [V] = 3 Vrms
IEC 61000-4-6
amateur bands (1.8 MHz to 2.0 MHz, 3.5 MHz to
Conducted RF
4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 [V] = 6 Vrms
MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2
MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to
21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz
to 29.7 MHz and 50.0 MHz to 54.0 MHz).
IEC 61000-4-3 10 V/m
[E] = 10 V/m
Radiated RF 80 MHz to 2.7 GHz
385 MHz 27 V/m
Proximity fields from 450 28 V/m
RF wireless 710
communications 745 9 V/m
equipment. 780
810 28 V/m


870
930
1720
Proximity fields from 28 V/m
1845
RF wireless
1970
communications
equipment. 2450
5240
5500 9 V/m
5785
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.
BLE Module with Chip Antenna Manufactured by Laird, Model BL652-SA
Tx
1. Operating frequency 2,400 GHz

2. Frequency band (if applicable) 2,402 - 2,480 GHz
3. Type of modulating signal Pulse Width Modulated
4. Frequency of modulating signal (Data rate) 1 Mbps (over-the-air)
5. Effective radiated power in dBm (W) Maximum transmit power setting +4 dBm
Rx
1. Operating frequency 2,402 - 2,480 GHz

2. Receive Sensitivity -96 dBm typical

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P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 1

P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 2

COPYRIGHTS AND DECLARATION

BEFORE YOU BEGIN

P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 3

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Page | 4 Novoxel.com P/N T2-UM-E-ENG Rev 10

Specifications of This Manual

Novoxel® Part Number: T2-UM-E-ENG Rev 10

P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 5

Glossary, Conventions, Abbreviations, Signs and Symbols

Page | 6 Novoxel.com P/N T2-UM-E-ENG Rev 10

P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 7

Signs and Symbols

EC REP Authorized EC Representative.

Caution; Consult accompanying documents.

Type B applied part (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 damage to

Hot! Do not touch, risk of injury.

Page | 8 Novoxel.com P/N T2-UM-E-ENG Rev 10

Operating State, Location and Position

 The product's ventilation should not be obstructed.

Following are the required operating position and conditions:

 The product is for indoor use only.

 General Operating Conditions:

 Maximum transport altitude: 4500 m ASL (~15,000 ft.).

Electrical Safety Information

Electrical Medical Equipment Classification

Equipment Classification: Class I

P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 9

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

 Never leave the system unattended in “Operate” mode.

1. WEEE = Waste Electrical and Electronic Equipment

P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 11

 EN 60335-2-23:2003 + A1:2008 + A11:2010.

 IEC 60335-2-23:2003 (Fifth edition) (incl. corr.2:2008) + A1:2008.

 + A2:2012, in conjunction with EN 60335-1:2012 (Fifth edition)3.

 IEC 60335-1:2010 (Fifth edition).

 EN 55014-1: 2006 + A1:2009 + A2:2011.

 EN 61000-3-2: 2006 + A1:2009 + A2:2009.

 EN 61000-3-3: 2008, EN 55014-2: 1997 + A1:2001 + A2:2008 + IS1:2007.

 SOR-98-282: 2014, Canadian Medical Device Regulations.

 The WEEE Directive 2012/19/EU, Management of Electronic Waste.

The Tixel2 device – Overview

Page | 12 Novoxel.com P/N T2-UM-E-ENG Rev 10

System Layout and Components

The Tixel2 Device

P/N T2-UM-E-ENG Rev 10 Novoxel.com Page | 13

Number Part Name

3.1, 3.2 Tixel2 Handpieces (left and right, respectively).

4.1, 4.2 Handpiece cradles (left and right, respectively).

6.1, 6.2 Handpiece umbilical cable (left and right, respectively).

7 Tixel2 Console decorative LED lighting.

List of Tixel2 Components

Page | 14 Novoxel.com P/N T2-UM-E-ENG Rev 10