InMode Morpheus8 Manuel utilisateur

Morpheus8 System

Operator Manual

Version: DO609736B

Operator Manual: Morpheus8 System

DO609736B

Date: December 2020

without the written permission of InMode Ltd.

🏭InMode Ltd

Tavor House. POB 533, Industrial Park South,

Yokneam, 2069206. Israel

Tel: +972-4-9096313

Fax: +972-4-9096310

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 System and Handpieces Labels .............................................................................. 7

2.10 Equipment Classification...................................................................................... 10

Section 3: System Installation................................................................................. 11

3.1 Electrical Requirements ....................................................................................... 11

3.2 Environmental Requirements .............................................................................. 11

3.3 Equipment List ..................................................................................................... 11

3.4 Unpacking............................................................................................................. 12

3.5 Installation ........................................................................................................... 13

3.6 Moving the System .............................................................................................. 13

3.7 System Disposal ................................................................................................... 13

Section 4: Device Description.................................................................................. 14

4.1 Rear Panel ............................................................................................................ 14

4.2 Front panel........................................................................................................... 14

4.3 Top Panel.............................................................................................................. 15

4.4 Software Screens.................................................................................................. 16

4.5 Sound Indicator.................................................................................................... 20

4.6 Handpieces........................................................................................................... 20

Section 5: System Operation................................................................................... 23

5.1 Device Start-Up .................................................................................................... 23

5.2 System Shutdown ................................................................................................ 23

Section 6: Morpheus8 Treatment Information ........................................................ 24

6.1 Sub-dermal Fractional Treatment........................................................................ 24

6.2 Indications for Use ............................................................................................... 24

6.3 Contraindications................................................................................................. 24

6.4 Possible Adverse Side Effects............................................................................... 26

6.5 Pre-treatment Recommendations....................................................................... 26

6.6 Test Spots............................................................................................................. 27

6.7 Treatment Recommendations ............................................................................. 29

6.8 Treatment Schedule............................................................................................. 30

6.9 Post-treatment Recommendations ..................................................................... 31

Section 7: Troubleshooting ..................................................................................... 32

7.1 Description of Faults with All Handpiece............................................................. 32

Section 8: System Specifications ............................................................................. 33

8.1 Output Power Curves........................................................................................... 34

8.2 EMC Safety........................................................................................................... 35

Table from IEC60601-1-2, / 5.2.2.1 C&F ............................................................ 39

Morpheus8 System Operator Manual

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 RF Pro Platform with the Morpheus Handpieces marketed as Morpheus8

System and employs bi-polar Radio-frequency (RF) technology for use in

dermatologic and general surgical procedures for electrocoagulation and hemostasis

for various aesthetic applications. 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.

Morpheus8 System Operator Manual

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

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

Sterilized by Radiation

Table 01-1: Device Symbols

Morpheus8 System Operator Manual

Section 2: Safety

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Section 2: Safety

This chapter describes safety issues regarding the use and maintenance of the

Morpheus8 System, 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 System

should be removed to avoid accidental RF conduction.

▪Patients will not be in contact with any metal or other alternate pathway to

ground whilst the System is in use.

2.2 Treating Attendant

▪Only authorized individuals with appropriate training and knowledge should

operate, assist in the operation of, or provide maintenance to the Morpheus8

System.

Morpheus8 System Operator Manual

Section 2: Safety

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▪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.

▪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 Handpieces 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 Handpieces 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.

Morpheus8 System Operator Manual

Section 2: Safety

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▪Keep drapes and towels moist to prevent them from igniting and burning. Use

nonflammable prepping solutions.

▪If alcohol is used for cleaning and disinfecting, it must be allowed to dry

thoroughly before the System is used.

▪Do not use the System in the presence of explosive or flammable materials.

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 Handpieces 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 Handpieces cords around metal objects. It may induce current

that could lead to electrical shocks, fire or injury to the patient or personnel.

▪The tips are for single use only. Do not try to reuse them. Re-use of the tips may

cause for unintended cross contaminations and infections, create loss of integrity

that may affect the performance and make the Device non-functional.

Do not connect a wet accessory to the System.

Do not immerse the applicator under water at any time.

Morpheus8 System Operator Manual

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 Handpieces manufactured or approved by InMode Ltd. should be used

with Morpheus8 System.

Connect the power cord to a properly polarized and grounded power

source with the frequency and voltage characteristics that match those

listed on the back of the unit.

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 Handpieces 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).

–Endogenous gases.

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