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MCT UNIT User Manual

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MCT® Unit
USER MANUAL
V0923

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  • Page 1 MCT® Unit USER MANUAL V0923...
  • Page 2 Notice Thank you for your interest in MCT Unit. Meta Cell Technology strives to provide our customers with the highest quality devices, systems, and services. This manual describes how to operate the MCT Unit system with the MCT Kit consumables. Please...

  • Page 3: Table Of Contents

    Table of Contents DEVICE ......................- 5 - TECHNICAL SPECIFICATIONS ..........- 9 - PROTOCOLS ..................- 11 - PROCEDURE ..................- 13 - MAINTENANCE ................. - 16 - CONFIGURATION ................- 17 - DEVICE SAFETY MEASURES AND TROUBLESHOOTING ..................- 20 - SYMBOLS ....................
  • Page 4 - 4 -...

  • Page 5: Device

    Commercial product name: MCT UNIT Model number: Intended purpose MCT UNIT is designed to be used in combination with the MCT Kit for the rapid obtention of platelet derivatives, such as growth factors and/or biological mediators, through the application of light and temperature.
  • Page 6 • Dermal regeneration Intented users MCT UNIT is used by physicians. They can be specialized traumatology, rheumatology, anesthesiology, rehabilitation, sports medicine, podiatry, dermatology, or any other related medical specialty. (Clinical) Indications: The device is indicated for all musculoskeletal or dermatological clinical specialty treatments that require PRP to achieve the stimulation and healing acceleration of tissue.
  • Page 7 Never spray water or detergent directly on the MCT Unit. Do not plug the unit into the wall outlet until the moisture from cleaning has evaporated. Do not operate any appliance with a power cord other than the official one supplied with the MCT Unit.
  • Page 8 MCT® UNIT Improves biological autologous material through the controlled emission electromagnetic energy. MCT® KIT® Device that stores the autolo- gous material to be boosted. Patented and developed with geometry and chemical compo- sition specific to the effective photothermal activation of auto- logous materials.

  • Page 9: Technical Specifications

    TECHNICAL SPECIFICATIONS Technology Peltier, LED Compatibility Cassette MCT® Capacity 10ml Maximum cooling temperature 4ºC Maximum heating temperature 45ºC Maximum air cooling rate 2ºC/min Maximum air heating rate 5ºC/min Temperature uniformity ≤ ±0.5ºC Precision of temperature measurement ≤ ±0.5ºC Temperature control mode...
  • Page 10 - 10 -...

  • Page 11: Protocols

    PROTOCOLS The device has three pre-set automatic protocols. They are individual and to be applied only once with each sample. Protocol #1. PRP. Photo-thermal stimulation Platelet Rich Plasma to obtain a higher concentration of ATP and growth factors, with a more prolonged physiological release.
  • Page 12 Protocol #3. Exosomes. Photo-thermal modulation for the stimulation exosomes releasing. - 12 -...

  • Page 13: Procedure

    Place the MCT® KIT® in the tray (with the autologous material inside). Reposition the tray in its slot in the MCT® UNIT. Select the desired preset. - 13 -...
  • Page 14 When selecting any of the presets, the energy parameters will be applied automatically. The MCT® UNIT will show the session screen, with the session time and total energy (J). By pressing Start, the MCT® UNIT will begin the session. Once started, a timer will show the session’s remaining time and the settings.
  • Page 15 A pop-up and an acoustic warning will indicate the session has ended and the MCT® KIT® may be removed from the MCT® UNIT’s tray. In addition, the session may be interrupted at any time by pressing the STOP button, which will display a message asking you to confirm this action.

  • Page 16: Maintenance

    MAINTENANCE Cleaning : Unplug the unit from the wall outlet before you begin cleaning it. Wipe the LCD screen gently with a soft cloth. When cleaning the body, wipe gently with a soft cloth lightly dampened in pure water. Stubborn stains may be removed with a solution of mild soap and warm water.

  • Page 17: Configuration

    CONFIGURATION The device has a menu where you can configure other interface options. There is an icon in the home screen’s top right corner, which will open the following menu when selected: Screen: Allows you to change the screen brightness with a simple intensity slider. Sound: Allows you to change the software’s volume.
  • Page 18 Custom This program allows the session to be freely configured so personalized protocols may be developed. If you select the CUSTOM program, you must manually configure all light and temperature parameters: select the wavelength or light color you wish to apply (specific button) adjust the intensity of each wavelength to be employed (slider or the +/- buttons)
  • Page 19 Below the session time you will see the total energy (J) to be applied depending on the configuration set. By pressing Start, the MCT® UNIT will begin the session and change to the specific screen. About MCT: Information on the software version.

  • Page 20: Device Safety Measures And Troubleshooting

    DEVICE SAFETY MEASURES AND TROUBLESHOOTING Location: MCT Unit should be used correctly placed on a flat surface, ensuring all four rubber feet are in place to allow proper air circulation and enough space to allow easy disconnection of the power cord.
  • Page 21 indicate that the session cannot be started until the incident is resolved. • If a code and an alarm text appear on the screen, you must contact the CLINIPRO technical service indicating the error code. - 21 -...

  • Page 22: Symbols

    SYMBOLS Symbol MANUFACTURER. This symbol is accompanied by the name and the address of the manufacturer Symbol “DATE OF MANUFACTURE” Symbol SERIAL NUMBER Symbol “Catalogue number” CE symbol with the intervention of the Notified Body IMQ 0051 Symbol for CONSULT INSTRUCTIONS FOR USE Symbol RAEE Symbol Medical Device...
  • Page 23 Symbol “Risk of electrical shock” Symbol “UDI” (01) UDI-DI (11) PRODUCTION DATE YYMM00 (21) SERIAL NUMBER Symbol “Alternating current” Symbol “Fuse” Symbol “Temperature limit” Symbol “Keep away from sunlight” Symbol “Fragile, handle with care” Symbol “Mandatory use of gloves” - 23 -...

  • Page 24: Terms Of Warranty

    TERMS OF WARRANTY MCT Unit is covered by a warranty lasting 2 years from the date of purchase on the fiscal document delivery (accompanying document confirming the date of purchase) and / or invoice. Warranty is limited to replacement or repair of individual components or pieces with manufacturing defects.
  • Page 25 Be sure to read the entire operation manual before using the product. The warranty is void if the medical device has been opened, tampered with, or repaired by unauthorized personnel. Defective devices must be reported and returned to an authorized distributor. Any serious incident related to the product must be reported to the manufacturer and to the competent authority of the Member State in which the user and/or...

  • Page 26: Lifespan And Disposal Of The Product

    LIFESPAN AND DISPOSAL OF THE PRODUCT MCT Unit has a lifespan of at least 9 years, provided it is used under the stated operating conditions and specified maintenance is performed. MCT Unit is an electrical/electronic device and must therefore be disposed of properly. Consult a local waste management center.
  • Page 27 metacelltech.com...

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