InMode Morpheus8 User manual

Morpheus8 Body Applicator
Operator Manual
Version: DO609806A

Operator Manual: Morpheus8 Body Applicator
DO609806A
Copyright © InMode Ltd.
Date: September, 2020
All rights reserved. Contents of this publication may not be reproduced in any form
without the written permission of InMode Ltd.
🏭InMode Ltd
Tabor House, Industrial Park South
POB 44, Yokneam 2069201, Israel
For information call: [phone]

Table of Contents
Section 1: Introduction ............................................................................................. 1
1.1 Before You Start..................................................................................................... 1
1.2 System Overview.................................................................................................... 1
1.3 Conventions Used in the Manual........................................................................... 1
1.4 Explanation of the Symbols used on the System................................................... 2
Section 2: Safety....................................................................................................... 3
2.1 The Patient............................................................................................................. 3
2.2 Treating Attendant................................................................................................. 3
2.3 Cautions ................................................................................................................. 4
2.4 Electrical and Mechanical Safety ........................................................................... 4
2.5 Fire Hazards............................................................................................................ 4
2.6 Safety Features of the System ............................................................................... 5
2.7 Safe use of the Active Accessories......................................................................... 5
2.8 Warnings ................................................................................................................ 6
2.9 Handpiece Label..................................................................................................... 7
2.10 Equipment Classification........................................................................................ 8
Section 3: System Installation................................................................................... 9
3.1 Electrical Requirements ......................................................................................... 9
3.2 Environmental Requirements ................................................................................ 9
3.3 Installation ............................................................................................................. 9
3.4 Moving the System .............................................................................................. 10
3.5 System Disposal ................................................................................................... 10
Section 4: Device Description.................................................................................. 11
4.1 Rear Panel ............................................................................................................ 11
4.2 Software Screens.................................................................................................. 12
4.3 Sound Indicator.................................................................................................... 16
4.4 Handpieces........................................................................................................... 16
Section 5: System Operation................................................................................... 18
5.1 Device Start-Up .................................................................................................... 18
5.2 System Shutdown ................................................................................................ 18
Section 6: Morpheus8 Body Treatment Information................................................ 19
6.1 Sub-dermal Fractional Treatment........................................................................ 19
6.2 Indications for Use ............................................................................................... 19
6.3 Contraindications................................................................................................. 19
6.4 Possible Adverse Side Effects............................................................................... 21
6.5 Pre-treatment Recommendations....................................................................... 21

6.6 Test Spots............................................................................................................. 22
6.7 Treatment Recommendations ............................................................................. 23
6.8 Treatment Schedule............................................................................................. 23
6.9 Post-treatment Recommendations ..................................................................... 24
Section 7: Troubleshooting ..................................................................................... 26
7.1 Description of Faults with All Handpiece............................................................. 26
Section 8: System Specifications ............................................................................. 27
8.1 Output Power Curves........................................................................................... 28
8.2 EMC Safety........................................................................................................... 29
Table from IEC60601-1-2, / 5.2.2.1 C&F ............................................................ 34

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Section 1: Introduction
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Section 1: Introduction
1.1 Before You Start
The manual and the equipment are for use only by qualified medical professionals
trained in the particular technique to be performed.
Federal (USA) law restricts sale of this device by or on the order of a physician.
Read this manual to become familiar with all safety requirements and operating
procedures before attempting to operate the System.
1.2 System Overview
The InMode Platform with the Morpheus8 Body Handpiece employs bi-polar Radio-
frequency (RF) technology for use in dermatologic and general surgical procedures
for electrocoagulation and hemostasis for various aesthetic applications. The
Morpheus8 Body Handpiece used with InMode platforms. The device provides
individual adjustment of treatment parameters to achieve maximum efficiency and
safety for each patient and applications.
1.3 Conventions Used in the Manual
The following conventions in the form of notes and warnings are used in this manual:
WARNING! This information is extremely important!
ATTENTION! Consult Accompanying Document.
NOTE! Provides general information that is important to keep in mind.

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Section 1: Introduction
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1.4 Explanation of the Symbols used on the System
Symbol
Description
CSA marking
(212603 CSA master contract number)
Do not discard in trash. Electronic equipment should
be disposed of in an appropriate manner
Fuse
Type BF Equipment
Type B Equipment.
HF Isolated Patient Circuit
Follow the operating instructions
Federal (US) law restricts this device to sale by the
order of a physician licensed by the law of the state
in which he practiced to use or order the use of the
device
Do not reuse/single use only. This symbol is used for
disposable one-time-use products.
This equipment intentionally supplies non-ionizing RF
energy
Table 01-1: Device Symbols

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Section 2: Safety
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Section 2: Safety
This chapter describes safety issues regarding the use and maintenance of the
Morpheus8 Body Handpiece, with a special emphasis on electrical safety.
The applicator is designed for safe and reliable treatment when used in accordance
with proper operation and maintenance procedures. Only trained, qualified
practitioners can use the system and the applicator. The operator and all other
personnel operating or maintaining the system should be familiar with the safety
information provided in this section.
The primary consideration should be to maximize safety for both treating attendant
and patient.
Read this chapter to be familiar with all its safety requirements and
operating procedures prior to system operation.
RF energy can cause injury if used improperly.
High voltage is present inside the System.
Always be aware of the possible dangers and take proper safeguards as
described in the manual.
2.1 The Patient
▪Well-trained staff is key for assuring patient safety. A patient history report
should be completed prior to scheduling. Patients should be fully informed of the
treatment details, the likely results and any risks associated with the treatment.
▪Jewelry and metal accessories that are within the activation range of the
Handpiece should be removed to avoid accidental RF conduction.
2.2 Treating Attendant
▪Only authorized individuals with appropriate training and knowledge should
operate, assist in the operation of, or provide maintenance to the device with
Morpheus8 Body Handpiece.
▪Personnel should not operate the System until they have been fully educated in
its use. Make sure that all treatment personnel are familiar with the System
controls and know how to shut down the System instantly.

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Section 2: Safety
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▪There are no user-serviceable parts in the System, and all service and repair must
be performed only by the factory or authorized field service technicians.
2.3 Cautions
The following cautions should be heeded for safe System use:
▪Do not touch the System’s inner parts.
▪Service is supplied by company authorized personal only.
▪To avoid damage, do not allow the Handpiece to come in contact with hard
materials.
2.4 Electrical and Mechanical Safety
▪Keep all covers and panels of the System closed. Removing the covers creates a
safety hazard.
▪Keep hands away from the applicator during the System start-up.
▪Perform maintenance procedures when the System is shut down and
disconnected from the power.
▪The System is grounded through the grounding conductor in the power cable.
This protective grounding is essential for safe operation.
▪Move the System slowly and carefully. The System weighs approximately 15kg
(33 lb.) and may cause injury if proper care is not used when moving it.
▪Provide as much distance as possible between the System, RF Handpiece and
other electronic equipment as the activated RF generator may cause interference
between them.
2.5 Fire Hazards
▪Materials conducting RF energy may cause temperature rise of the absorbing
material. Do not use the System in the presence of explosive or flammable
materials conductive to RF.
▪Do not use flammable substances when preparing the skin for treatment. Be
especially careful with the use of oxygen.
▪Keep drapes and towels moist to prevent them from igniting and burning. Use
nonflammable prepping solutions.

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Section 2: Safety
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▪If alcohol is used for cleaning and disinfecting, it must be allowed to dry
thoroughly before the System is used.
2.6 Safety Features of the System
The System incorporates the following safety features. All personnel operating the
System should be familiar with these features.
▪The System has unique password to avoid device operation by non-authorized
personnel.
▪The power electronics cannot be activated unless the applicator and Footswitch
have been connected to the System.
▪An audible tone indicates energy activation.
▪During activation, the System performs a self-test of the hardware.
▪Hardware is tested every 10ms to ensure proper operation of electrical circuit.
▪The System starts at a low setting.
2.7 Safe use of the Active Accessories
▪Examine the connection of the Handpiece through the connectors to the System
before using. Ensure that the accessory functions as intended. Improper
connection may result in arcs and sparks, accessory malfunction, or unintended
treatment effects.
▪Do not wrap the Handpiece cords around metal objects. It may induce current
that could lead to electrical shocks, fire or injury to the patient or personnel.
Do not connect a wet accessory to the System.
Do not immerse the applicator under water at any time.

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Section 2: Safety
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2.8 Warnings
This equipment is for use only by qualified medical professionals trained in
the particular technique to be performed.
Only Handpiece manufactured or approved by InMode Ltd. should be used
with InMode System with Morpheus8 Body Handpiece.
Connect the power cord to a properly polarized and grounded power
source with the frequency and voltage characteristics that match those
listed on the back of the unit.
Connect the System power cord to a properly grounded receptacle. Do not
use power plug adapters.
Always turn off and unplug the device before cleaning.
The patient should not come into contact with metal parts which are
earthed or which have an appreciable capacitance to earth. The use of
antistatic sheeting is recommended for this purpose. Treatment bed or
chair should not be electric.
Use the lowest output setting necessary to achieve the desired treatment
effect. The higher RF is applied, the greater the possibility of unintended
thermal damage.
Failure of the equipment could result in an unintended increase of output
power.
The cables of the Handpiece should be positioned in such a way that
contact with the PATIENT or other leads is avoided.
Fire / Explosion Hazard - The following substances will contribute to
increased fire and explosion hazards in the operating room:
–Flammable substances (such as alcohol-based skin prepping agents and
tinctures).
–Naturally occurring flammable gases which may accumulate in body
cavities such as the bowel.
–Oxygen enriched atmospheres.
–Oxidizing agents (such as nitrous oxide [N2O] atmospheres).

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Section 2: Safety
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–Endogenous gases.
The RF energy and heating associated with the System can provide an
ignition source. Observe fire precautions at all times. When using InMode
System with Morpheus8 Body Handpiece in the same room with any of
these substances or gases, prevent their accumulation or pooling within the
area where Morpheus8 Body procedures are performed.
The operation of the InMode System with Morpheus8 Body Handpiece may
adversely influence the operation of other electronic EQUIPMENT.
To avoid the RISK of electric shock, this equipment must only be connected
to a SUPPLY MAINS with protective earth.
2.9 Handpiece Label
As required by national and international regulatory agencies, appropriate warning
and information labels have been attached in specific locations on the instrument as
identified below.
The Handpiece certifications and identification labels are attached to connectors on
the Handpieces. It states that the product conforms to the performance standards,
and indicates the manufacturer’s name, date of manufacturing, model and serial
number of the Handpiece. The following labels are located on the Handpiece:
Manufacturer identification labeling is placed on the Handpiece:
Figure 2-1: Morpheus8 Body Handpieces Identification Label

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Figure 2-2: Morpheus8 Body Tip Identification Label
2.10 Equipment Classification
The following is a list of the different equipment used and their classifications.
▪Electric shock protection: Class I, Type BF for the RF Handpiece.
▪Protection against ingress of liquids: Ordinary equipment.
▪Not suitable for use in presence of flammable substance.
▪Power receptacle must include protective earth and must be checked before
connecting the System.
The InMode Systems with the Morpheus8 Body Handpiece is classified as Class II
device defined by the FDA CDRH and complies with 21 CFR subparts E.

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Section 3: System Installation
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Section 3: System Installation
3.1 Electrical Requirements
▪The System will require a separate line supply of single phase (100Vac; 15A) or
(115Vac; 15A) or (230Vac; 15A) or (240Vac; 15A) 50-60Hz. Zmax = 0.03Ω.
▪Power receptacles must be within 15 feet of the System site.
▪The System should not share a power line with other equipment.
▪Power receptacle must include protective earth and must be checked before
connecting the System.
For continued protection against fire, replace the fuse only with one of the
same type and rating.
Proper grounding is essential for safe operation.
3.2 Environmental Requirements
▪Corrosive materials can damage electronic parts; therefore, the System should
operate in a non-corrosive atmosphere.
▪For optimal operation of the System, maintain room temperature between
20º-27ºC (68º-79ºF) and relative humidity of less than 80%.
3.3 Installation
The System is designed for installation in a clinic environment. To install the System,
perform the following tasks:
▪Check the System and all its components for damage.
▪Connect cradle to the device.
▪Connect Handpiece to the connector and place into the cradle.
▪Connect the Footswitch.
▪Connect the power cord to the System inlet.

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Section 3: System Installation
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▪Plug the System Power Cord into an appropriate electrical outlet.
3.4 Moving the System
▪Turn the System off.
▪Disconnect the Power Cord.
▪Disconnect the Handpiece.
▪Disconnect the Footswitch.
▪Release the Wheel Brakes.
▪Slowly push or pull the System using the handle.
▪When moving the System to another facility, lift the System to the vehicle and lay
it carefully on its side.
Never lift, pull or push the System using the operating panel.
Always use the handles when moving the System.
Upon unpacking, check the System for mechanical damage (e.g., cracks in
the cable insulation).
3.5 System Disposal
To comply with European Commission Directive 2002/96/EC on Waste Electrical and
Electronic Equipment (WEEE) and other country and state regulations, please DO
NOT dispose of this equipment in any location other than designated locations.

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Section 4: Device Description
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Section 4: Device Description
4.1 Rear Panel
Power Cord Inlet
100-240V~, 15A, 50-60Hz.
Fuse Holder
Rating is T 12A, 250V. Replace fuses if needed, only with fuses having
exactly the same rating.
Software Flash Memory Plug
The software plug is a flash memory with the machine software. The
software plug should be screwed to the connectors. To tighten and/or
loosen the screws use fingertips only. Do not use screwdriver as it can
damage the connectors.
Footswitch Connector
Footswitch is connected to the inlet. Footswitch activates RF energy if
the System is in Ready mode. Place the Footswitch on the floor near
the treatment area.
!!


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Section 4: Device Description
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4.2 Software Screens
The Progress screen appears after the On-Off switch is turned on.
Figure 4-1: Progress Screen
*The SW version number will be displayed according to the software version.
After entering the individual code on the Login Screen, non-authorized use of the
device is prevented.
Figure 4-2: Login Screen

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Section 4: Device Description
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Software is loaded from the plug and self-test of the System modules is performed.
After the end of the self-test the Menu Screen appears.
Figure 4-3: Menu Screen
The Menu Screen allows the selection of the connected Handpiece, or entry to the
Utilities Screen.
Figure 4-4: Utilities Screen

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Section 4: Device Description
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The Utility Screen contains:
Volume
This function allows the user to adjust the System volume.
Change
Password
Change the password by entering the old password and then
entering another 4-digit password.
Calibration
N/A
Main Menu
Return to the Main Menu to select an applicator.
After returning to the Menu Screen and choosing the application on the Menu
Screen, the corresponding Treatment Screen appears.
Figure 4-5: Morpheus Treatment Screen
Tip
Allows selecting the Tip.
Available Tips are:
•Morpheus8 Body Applicator: 40 Pin tip.
Depth
Allows selecting the pins length and penetration depth
according to dermis thickness in treated area to provide
effective sub-dermal treatment. Available depths are: for 40
pins tip 2, 3, 4, 5, 6 and 7mm.
Energy
Delivered energy is changed from level 5 to 60 energy levels
and the System starts up at the minimal energy setting.
Mode
•Selects between:
•Cycle mode when needle goes out and in at each pulse
•Fixed mode when needles goes out at foot switch
pressing and stay protruded until Footswitch is
released. In Fixed mode RF pulses are applied
automatically with predetermined pulse repetition rate.

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•Burst mode - the energy is delivered automatically at
up to 3 different tissue layers within the same single
cycle. When activated, the needles are deployed into
the tissue and when retracts the needles are stopped
every 2 mm in subdermal space and RF energy is
delivered. For example, when choosing treatment
depth of 7mm the energy will be delivered within the
same pulse cycle, first at 7 mm, then 5 mm, then 3 mm.
When choosing 6 mm depth, the energy will be
delivered at 6 mm, then 4 mm and then 2mm.
Depth Setting
Burst Mode
Depth of RF Energy Release
7mm
7mm, 5mm, 3mm
6mm
6mm, 4mm, 2mm
5mm
5mm, 3mm
4mm
4mm, 2mm
When switching from Cycle/Fixed Mode with Depth Settings 1, 2
or 3mm to Burst Mode the Depth Settings automatically will be
adjusted to 4mm
Repetition
Select between single pulse delivery at Footswitch pressing and
autorepeat mode with predetermined pulse repletion rate
Counter Reset
Counter can be reset number of pulses per zone.
Pulse Counter
Shows number of pulses delivered on one zone and total
number of pulses from the beginning of the treatment.
System Mode
The System has three treatment modes: Standby, Ready, and
Active.
Standby mode allows the user to set treatment parameters.
Activation of energy is not allowed in Standby mode.
In Ready mode, the system is waiting for a signal from the foot
switch to activate the energy. Any attempt to change the
treatment settings switches the system to Standby mode.
When the signal from the Footswitch is indicated, the system
switches to Active mode. Any attempt to change the treatment
settings switches the system to Standby mode.
Main Menu
Return to the Main Menu to select another applicator and
change the applicator if needed.

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Section 4: Device Description
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4.3 Sound Indicator
▪A periodic tone indicates that RF is delivered.
▪A warning sound tone indicates Bad Coupling.
4.4 Handpieces
Morpheus8 Body Handpieces (Error! Reference source not found.) comprise motor
with actuator pushing needle electrodes out to pre-determined depth up to 7mm.
The tip (Figure 4-7) is connected or disconnected with the Handpiece.
Figure 4-6: Morpheus8 Body Handpiece
Figure 4-7: Morpheus8-40 Pins Tip (Body)
Tip
The tips comprise 40 needles that are coated along with an insulating
material except the distal 0.5mm edge (Figure 4-8). Note the insulation that
leaves only the 0.5mm tip exposed.
Handle
The Handpiece handle is made of plastic and has an ergonomic design for
easy treatment, with high visibility of the treated area.