Table of Contents
Advertisement
Advertisement
Table of Contents
Related Manuals for InMode Morpheus8
Summary of Contents for InMode Morpheus8
- Page 1 Operator Manual Morpheus8 Body Applicator Version: DO609806A...
- Page 2 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...
-
Page 3: Table Of Contents
Handpieces ......................16 Section 5: System Operation ................... 18 Device Start-Up ....................18 System Shutdown ....................18 Section 6: Morpheus8 Body Treatment Information ..........19 Sub-dermal Fractional Treatment ................ 19 Indications for Use ....................19 Contraindications ....................19 Possible Adverse Side Effects ................21... - Page 4 Test Spots ......................22 Treatment Recommendations ................23 Treatment Schedule ..................... 23 Post-treatment Recommendations ..............24 Section 7: Troubleshooting ..................26 Description of Faults with All Handpiece ............. 26 Section 8: System Specifications ................27 Output Power Curves ................... 28 EMC Safety ......................
-
Page 5: Section 1: Introduction
System. 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. -
Page 6: Explanation Of The Symbols Used On The System
Morpheus8 Body Applicator Operator Section 1: Introduction Manual 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... -
Page 7: Section 2: Safety
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. -
Page 8: Cautions
Morpheus8 Body Applicator Operator Section 2: Safety Manual ▪ 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. Cautions The following cautions should be heeded for safe System use: ▪... -
Page 9: Safety Features Of The System
Morpheus8 Body Applicator Operator Section 2: Safety Manual ▪ If alcohol is used for cleaning and disinfecting, it must be allowed to dry thoroughly before the System is used. Safety Features of the System The System incorporates the following safety features. All personnel operating the System should be familiar with these features. -
Page 10: 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. -
Page 11: Handpiece Label
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. -
Page 12: 2.10 Equipment Classification
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. -
Page 13: Section 3: System Installation
Morpheus8 Body Applicator Operator Section 3: System Installation Manual Section 3: System Installation 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. -
Page 14: Moving The System
Morpheus8 Body Applicator Operator Section 3: System Installation Manual ▪ Plug the System Power Cord into an appropriate electrical outlet. Moving the System ▪ Turn the System off. ▪ Disconnect the Power Cord. ▪ Disconnect the Handpiece. ▪ Disconnect the Footswitch. -
Page 15: Section 4: Device Description
Morpheus8 Body Applicator Operator Section 4: Device Description Manual Section 4: Device Description 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. -
Page 16: Software Screens
Morpheus8 Body Applicator Operator Section 4: Device Description Manual 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. - Page 17 Morpheus8 Body Applicator Operator Section 4: Device Description Manual 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.
- Page 18 Figure 4-5: Morpheus Treatment Screen 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.
- Page 19 Morpheus8 Body Applicator Operator Section 4: Device Description Manual • 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.
-
Page 20: Sound Indicator
A warning sound tone indicates Bad Coupling. 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. - Page 21 Section 4: Device Description Manual Cable The Cable has a length of 270cm. Connector The Connector is connected to the front panel of the System. Figure 4-8: Morpheus8 Body tip needle structure The insulation leaves only the 0.5mm tip exposed. 17 of 34...
-
Page 22: Section 5: System Operation
Morpheus8 Body Applicator Operator Section 5: System Operation Manual Section 5: System Operation This section of the manual explains how to start the device, operate it, and turn it off. Prior to using or connecting the Handpiece, inspect the System and Handpiece for possible mechanical damage. -
Page 23: Section 6: Morpheus8 Body Treatment Information
Section 6: Morpheus8 Body Treatment Information Sub-dermal Fractional Treatment The Morpheus8 Body Handpiece is designed for delivering RF energy to the subdermal tissue in a fractional manner with the energy applied to <5% of the total coverage area. The energy is delivered to the skin through bipolar arrays of coated needles and results in localized heating and coagulation of the tissue that is in direct contact with the needle tip. - Page 24 Morpheus8 Body Applicator Operator Section 6: Morpheus8 Body Treatment Manual Information ▪ Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications. ▪ Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.
-
Page 25: Possible Adverse Side Effects
▪ Asian patients and those with skin types IV-VI should be treated gradually by bleaching products 6 weeks prior treatment and stop at least 48 hours prior Morpheus8 Body treatment to minimize risk of post inflammatory hyper- pigmentation. ▪ Prophylactic antiviral therapy should be prescribed for patients with history of cold sores (Herpes Simplex) when treating around the mouth. -
Page 26: Test Spots
The patient should shave the area to be treated. Long and dense hairs prevent electrode contact with the skin’s surface. The Morpheus8 tip arrives gamma-sterilized and is single use only! These tips SHOULD NOT be autoclaved or re-sterilized by any other technology! When choose "Fractional" on Menu Screen, the connected Morpheus8 Body handpiece with tip is performing self -test. -
Page 27: Treatment Recommendations
Morpheus8 Body Applicator Operator Section 6: Morpheus8 Body Treatment Manual Information Treatment Recommendations Apply the necessary means of anesthesia. If topical, make sure that it is cleaned off the treatment area before treatment and the surface is dried with alcohol 70%. -
Page 28: Post-Treatment Recommendations
Morpheus8 Body Applicator Operator Section 6: Morpheus8 Body Treatment Manual Information Treatment should be concluded when the results are satisfactory to the patient or according to the physician's discretion. Generally, 3-5 sessions are needed for mild to moderate depth settings. It is not typical to perform more than five consecutive sessions however more sessions can be performed as per physician discretion. - Page 29 Morpheus8 Body Applicator Operator Section 6: Morpheus8 Body Treatment Manual Information of post inflammatory hyper-pigmentation. It should be stopped 48-72 hours before another Morpheus8 Body session. 25 of 34...
-
Page 30: Section 7: Troubleshooting
Section 7: Troubleshooting Manual Section 7: Troubleshooting The InMode System with Morpheus8 Body Handpiece provides monitoring of all critical parameters to ensure safety of patient and user. If any of the following faults are detected system automatically goes to STAND BY mode. -
Page 31: Section 8: System Specifications
Morpheus8 Body Applicator Operator Section 8: System Specifications Manual Section 8: System Specifications Input Power Main Line Frequency (nominal) 50-60Hz Input Voltage (nominal) 100-240VAC Input Current (rms) Operating Parameters Ambient Temperature Range 15 – 30°C [59 – 86°F] Relative Humidity... -
Page 32: Output Power Curves
2.34 2.34 2.34 2.34 Full Power Half Power 2.00 1.00 0.00 Load Resistance [Ω] Figure 08-1: Morpheus8 Body Output Power versus Impedance The following curves depict Peak Voltage vs. Power Settings. Figure 08-2: Output Power Versus Impedance 28 of 34... -
Page 33: Emc Safety
The InMode System with Morpheus8 Body Handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the InMode System with Morpheus8 Body Handpieces should assure that it is used in such an environment. - Page 34 Morpheus8 Body Applicator Operator Section 8: System Specifications Manual RF emissions CISPR 11 Class A The InMode System with Morpheus8 Body Handpiece is suitable for use in all Harmonic emissions Complies establishments other than domestic and IEC 61000-3-2 those directly connected to the public...
- Page 35 The InMode System with Morpheus8 Body Handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the InMode System with Morpheus8 Body Handpieces should assure that it is used in such an environment.
- Page 36 AC mains voltage prior to application of the test level. Guidance and manufacturer’s declaration – electromagnetic immunity The InMode System with Morpheus8 Body Handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the InMode System with Morpheus8 Body Handpiece should assure that it is used in such an environment.
- Page 37 Recommended separation distances between portable and mobile RF communications equipment and the InMode System with Morpheus8 Body Handpiece System The InMode System with Morpheus8 Body Handpiece System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The...
- Page 38 Morpheus8 Body Applicator Operator Table from IEC60601-1-2, / 5.2.2.1 C&F Manual Table from IEC60601-1-2, / 5.2.2.1 C&F 34 of 34...
Need help?
Do you have a question about the Morpheus8 and is the answer not in the manual?
Questions and answers