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Related Manuals for classys Technology ULTRAFORMER MPT
Summary of Contents for classys Technology ULTRAFORMER MPT
- Page 1 OPERATION MANUAL Ver. 1.0...
- Page 2 Improper use of the system may cause injury to parties and/or may cause damage to the system that may void the warranty agreement. Note 1. This user manual describes the operation of the ULTRAFORMER MPT only. It is not a substitute for the required clinical training to use the system.
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Page 3: Table Of Contents
Table of Contents 1. Introduction to Manual 5. System Operation 1-1. Purpose 5-1. Overview of System Functions 1-2. Conventions 5-2. Activating the System 5-3. Treatment Steps 2. Safety Information 5-4. Shutting Down the System 2-1. Indications for Use 2-2. Contraindications 6. -
Page 4: Introduction To Manual
1. Introduction to Manual 1-1. Purpose This manual provides a description of the ULTRAFORMER MPT system components, displays, operational instructions and other related information vital to the functions of the system. Classys Inc. provides this manual in English by default. If the customer requires a translated manual in another language, we will proceed with the request to the appropriate country distributor. -
Page 5: Safety Information
Pregnancy or when breastfeeding ⚫ 2-3. Precautions Do not use the equipment without prior training and qualifications to operate the ULTRAFORMER MPT. Consult with experts or use a diagnostic device to check the depth to decide whether treatment is appropriate. Anticoagulant therapy ⚫... -
Page 6: Potential Side Effects
Scarring: If incorrect treatment techniques are used, scarring formations may occur. ⚫ Nerve effects: ⚫ - Transient local muscle weakness may result after treatment due to inflammation of a motor nerve. - Transient numbness may result after treatment due to inflammation of a sensory nerve. ULTRAFORMER MPT Operation Manual... -
Page 7: Complaints And Adverse Events
- No permanent injuries to facial nerves have been reported. 2-5. Complaints and Adverse Events No serious or adverse observations were made from the use of the preceding equivalent devices in reference to the clinical study. ULTRAFORMER MPT Operation Manual... -
Page 8: System Overview
The life cycle of ULTRAFORMER MPT is 5 years. 3-2. System Components and Features The ULTRAFORMER MPT consists of the following primary components as shown in the Figure 3.1: The Main Body with the integrated 10.4-inch touchscreen, Hand-piece cable, AC Power cable and interchangeable Cartridges. - Page 9 Foot switch 3-2-1. Main Body The Main Body is the information center for the ULTRAFORMER MPT. It houses the Graphic User Interface (GUI) that allows the user to interact with the device. This screen sets and displays the operating conditions including equipment activation status, treatment parameters, and system messages.
- Page 10 Hand-piece Connector Cover Cover of socket for plugging in Hand-piece cable The cartridges can be mounted with the cover Cartridge holder (Back side) where the connector connecting the body. Main Power Switch AC power ON/OFF Switch ULTRAFORMER MPT Operation Manual...
- Page 11 Laches on either side for disconnecting on the Hand- Cartridge Disconnect Switch piece Ultrasound Output Switch Hand-piece trigger to apply shot Firmware connect cover Connect cover when firmware of Hand-piece changed Hand-piece cable Cable for connecting Main Body and Hand-piece ULTRAFORMER MPT Operation Manual...
- Page 12 The types of Cartridges vary in frequencies and treatment depths as shown in Table 3.1. Cartridge Type Function Remark Frequency: 7MHz, Depth: 1.5mm, ULTRAFORMER MPT 1.5 Max. Power: 0.5J Frequency: 7MHz, Depth: 3.0mm, ULTRAFORMER MPT 3.0 Max. Power: 1.0J Frequency: 5.5MHz, Depth: 2.0mm, ULTRAFORMER MPT 2.0...
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Page 13: Precautions For Use
Power supply must be 100-240V~, 50/60Hz to operate the system safely. ⚫ The ULTRAFORMER MPT is intended for indoor, dry location use. Avoid liquid spills and splashes. Do not place the System in vicinity of direct sun light, high humidity or nearby heating ⚫... - Page 14 The ULTRAFORMER MPT comes with a three-conductor AC power cable and plug. Use a ⚫ properly grounded outlet and always plug the ULTRAFORMER MPT directly into the outlet. Never remove the ground conductor via any AC adaptor plugs or extension cables.
- Page 15 ⚫ 3-3-3. Electromagnetic Compatibility and Immunity The RF emission of the "ULTRAFORMER MPT" meets the requirements of the safety standard for medical equipment. Therefore, it causes almost no interference. Its energy requirement is mainly commercial. However, a hospital installation is required except for near active HF surgical equipment and the RF shielded room for a system of magnetic resonance imaging, where the intensity of EM precautions is high.
- Page 16 Warning: Use of “ULTRAFORMER MPT” adjacent to, or stacked with, other equipment should be avoided because it could result in improper operation. If such use is necessary, “ULTRAFORMER MPT” and the other equipment should be monitored to verify that they are operating normally.
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Page 17: Safety Symbols
Serial Number Date of Manufacture Manufacturer Storage Temperature Relative Humidity Atmospheric Pressure Limits Caution General Warning, Caution, Risk of Danger Mind instruction for use Pushing prohibited Sitting prohibited Stepping prohibited Crossed-out Wheelie bin Protective Earth ULTRAFORMER MPT | 14 Operation Manual... -
Page 18: Setting Up For First-Time Use
System weight and dimensions are additionally listed in “Specifications” (Refer to Section 8) of this User Manual. Figure 4.1. The required storage area for the ULTRAFORMER MPT 4-2-2. Electromagnetic Environment The system is unlikely to cause interference to nearby electronic equipment; however, other electronic equipment must not be stacked or placed immediately adjacent to the System. - Page 19 Ensure the AC power cable connected from the back of the System is plugged into the wall socket. For electrical safety, connect the external ground terminal of the device to a separate ground terminal. ULTRAFORMER MPT | 16 Operation Manual...
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Page 20: System Operation
An overview of this screen is seen in Figure 5.1 below. Figure 5.1 Initial screen 5-1-2. Operating Graphical User Interface When you select the Hand-piece, display screen is as shown Figure 5.2. < ULTRA F > < ULTRA BOOSTER > Figure 5.2 Setting screen ULTRAFORMER MPT | 17 Operation Manual... - Page 21 After one shot, pause for a set time and then output the next shot. (Pause time is 0.1~1 second) Irradiation while moving by a set pitch during ultrasonic output When outputting ultrasound, irradiate at once without stopping ULTRAFORMER MPT | 18 Operation Manual...
- Page 22 Figure 5.3 Setup / Info GUI SIGN Description Setting volume ( 0 ~ 5 ) Display of available trigger sources. (Hand or Foot/ Only hand-piece button / Only Foot switch) Hand-piece automatic recognition function ON / ULTRAFORMER MPT | 19 Operation Manual...
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Page 23: Activating The System
For the safety of patients, operators and electrical safety, connect the external ground terminal of the device to a separate ground terminal in the room. 5-2-2. Ensure the Main Power Switch is in the ON position. 5-2-3. Press the power button to turn the System ON. ULTRAFORMER MPT | 20 Operation Manual... -
Page 24: Treatment Steps
A beeping sound will occur when the correct number of treatment lines is delivered. 5-3-10. When treatment is complete on the target region, press the “READY” button. 5-3-11. Place the Hand-piece on the Hand-piece holder. ULTRAFORMER MPT | 21 Operation Manual... -
Page 25: Shutting Down The System
5-4-2. The Main Power Switch on the rear of the Main Body should be OFF. The System may be switched OFF when moving the equipment between rooms or for storage or cleaning purposes. 5-4-3. Follow maintenance and storage instructions shown in Section 7 of this manual. ULTRAFORMER MPT | 22 Operation Manual... -
Page 26: System Messages
6. System Messages The ULTRAFORMER MPT is designed with internal checks to ensure that all aspects of the equipment are functioning appropriately. Please follow the instructions and refer to the information listed below when errors occur. Error Message Description Corrective Action 1. - Page 27 3. If the problem persists please contact Classys Inc. support. 1. Pull the trigger switch only if the system status is on “ready”. W-09 Fire switch pressed 2. If the problem persists please contact Classys Inc. support. ULTRAFORMER MPT | 24 Operation Manual...
- Page 28 Check the network settings. Check the network settings and contact Network Error(Server) customer service if there is no problem Cannot connect to the server. If W-14 the error reoccurs, please contact your local distributor or manufacturer. ULTRAFORMER MPT | 25 Operation Manual...
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Page 29: Cleaning And Storage
Clean the visible contaminants on the main Clean each visible ① ① body and hand-piece surfaces with new Cotton contaminant cloth. Cartridge surface with a Wash every 10 to 15 days for long-term new cotton cloth. ② ULTRAFORMER MPT | 26 Operation Manual... -
Page 30: General Care Of The System
7-2. General Care of the System To achieve a longer lifetime and use of the ULTRAFORMER MPT, treat the equipment carefully by adhering to the following guidelines: Inspect the Hand-piece and Cartridges regularly for any issues. -
Page 31: Movement, Storage And Disposal
7-3. Movement, Storage and Disposal 7-3-1. Movement Handle the ULTRAFORMER MPT with caution at all times. ⚫ Unlock the Main Body casters and using the knob, move the equipment to the ⚫ desired site. 7-3-2. Storage Avoid direct sunlight and/or excessive moisture, wind and dust. Also keep away from the heater. - Page 32 Warning of pop-up in license expiration To use ULTRAFORMER MPT, it should be registered a license by Classys, and when the renewal of license is close to expiration, the pop-up window is generated as follows. The screen of license renewal (automatic) <Set up>...
- Page 33 Figure ④. 7-4-2. Software management 1) The screen of Software management ① The software version is displayed on the screen. ② It displays the serial number of this software. ULTRAFORMER MPT | 30 Operation Manual...
- Page 34 - Generate an install button when the download is complete: When the download is completed, the user can touch the “install” button, and install the update file on the main ULTRAFORMER MPT | 31 Operation Manual...
- Page 35 - Displayed by adding 1 hour to the existing time when activated - Show existing time when deactivated 7-4-4. Network setting 1) Network setting screen ① ON/ OFF the WIFI ② Refresh the WIFI list ULTRAFORMER MPT | 32 Operation Manual...
- Page 36 - Details button ⑤ Add the other network 2) WIFI information screen ① Status the WIFI connection ② WIFI address ③ WIFI information display -IP address, Subnet Mask, Router 3) Add the other network ULTRAFORMER MPT | 33 Operation Manual...
- Page 37 ② Input the WIFI name: Input method editor(IME) appears when input is made. ③ Input the WIFI password: Input method editor(IME) appears when input is made. 7-4-5. Software management 1) Software management screen ① Software version ② Serial number ③ Check the software update ULTRAFORMER MPT | 34 Operation Manual...
- Page 38 ① Display the latest software version ② Download and install the latest software -Create a program bar when downloading. -Create the install button when download completed 7-4-6. Recommended Specification of WIFI LAN Dongle 1) Wireless standard: IEEE 802.11n/b/g ULTRAFORMER MPT | 35 Operation Manual...
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Page 39: Specifications
Class I, Type B against electrical shock Dimension 570(L) X 630(W) X 1330(H) mm Weight 37kg ULTRAFORMER MPT 1.5/ ULTRAFORMER MPT 2.0 Cartridge ULTRA F ULTRAFORMER MPT 3.0 /ULTRAFORMER MPT 6.0 (Optional) ULTRAFORMER MPT 9.0 /ULTRAFORMER MPT 13.0 ULTRAFORMER MPT... - Page 40 - Temperature: 10℃ - 35℃ - Relative Humidity: 0% - 90% - Air Pressure: 700hpa - 1060hPa Environmental [Shipping and Storage] - Temperature: 5℃ - 60℃ - Relative Humidity: 0% - 90% - Air Pressure: 500hpa - 1060hPa ULTRAFORMER MPT | 37 Operation Manual...
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Page 41: Appendix A. Electromagnetic Emissions And Immunity
Appendix A. Electromagnetic Emissions and Immunity Manufacturer’s declaration - electromagnetic emission The ULTRAFORMER MPT is intended for use in the electromagnetic environment specified below. The customer or the user of ULTRAFORMER MPT should assure that it is used in such an environment Emission test Compliance Electromagnetic environment - guidance The ULTRAFORMER MPT uses RF energy only for its internal function. - Page 42 The ULTRAFORMER MPT is intended for use in the electromagnetic environment specified below. The User or Licensee of the ULTRAFORMER MPT should assure that it is used in such an environment. Electromagnetic Immunity test IEC 60601 Test level Compliance level Environment -guidance 0% Uт...
- Page 43 Head Office Classys, 208, Teheran-ro, Gangnam-gu, Seoul, Republic of Korea. Factory A-1501~1515, 15F/ A-801~815, 8F/ B-701~715, 7F, H Businesspark, 25, Beobwon-ro 11-gil, Songpa-gu, Seoul, Republic of Korea. Tel: +82-2-517-2114 Fax: +82-2-6008-3457 Homepage: www.classys.com E-mail: info@classys.com ULTRAFORMER MPT | 40 Operation Manual...
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