MCT Unit User manual

MCT® Unit
USER MANUAL
V0923

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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
thoroughly familiarize yourself with this manual to
make the most effective use of the device and the
consumables.
Observe all cautionary instructions, safety messages,
and warnings that appear in this manual.
Due to continued technological improvements, this
manual may not contain the most updated information
and is subject to change without prior notice. You can
find the latest version of this manual at
www.metacelltech.com/manuals.
Additional learning resources available at
https://metacelltech.com/elearning/.
Document Revision: RevF, 2023-09
Copyright
All rights reserved. No parts of the content of this manual may be
reproduced or distributed to the public, without the prior written permission
of CLINIPRO SL.

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Table of Contents
01. DEVICE ........................................................................................................- 5 -
02. TECHNICAL SPECIFICATIONS................................................. - 9 -
03. PROTOCOLS .........................................................................................- 11 -
04. PROCEDURE ........................................................................................ - 13 -
05. MAINTENANCE .................................................................................- 16 -
06. CONFIGURATION............................................................................. - 17 -
07. DEVICE SAFETY MEASURES AND
TROUBLESHOOTING ....................................................................................- 20 -
08. SYMBOLS............................................................................................... - 22 -
09. TERMS OF WARRANTY ..............................................................- 24 -
10. LIFESPAN AND DISPOSAL OF THE PRODUCT.........- 26 -

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EN
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01. DEVICE
Commercial product name: MCT UNIT
Model number: MCT UNIT
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.
MCT UNIT is used by physicians for PRP derivatives
that will be subsequently re-administered to the
patient.
Same as PRP indications.
Indications of use
The device is indicated for all musculoskeletal or
dermatological clinical specialty treatments that
require PRP to achieve the stimulation and healing
acceleration of tissue.
PRP may be used for:
• Osteoarthritis
• Tendinopathies
• Muscle injuries
• Local pain
• Scar corrections
• Wound healing

EN
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• Dermal regeneration
Intented users
MCT UNIT is used by physicians. They can be
specialized in 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.
Contraindications:
There are no known contraindications when used as
directed.
The same as those associated with the related
medical procedures.
Warnings / Precautions:
The warnings are related to the electrical risks for the
operator.
The device should only be used by authorized and
qualified staff.
The instructions for use of the equipment must
be strictly followed because of the treatment of the
patient is effective.

EN
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If there is a power outage or a treatment protocol
is interrupted, the sample must be discarded and
started over, using a new MCT Kit.
It is mandatory to wear CE marked medical device
gloves to operate and clean the equipment.
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.
Do not use any attachments/parts not supplied by the
manufacturer. The use of parts not recommended or
provided by the manufacturer may cause serious
hazardous situations including personal injury.
Do not use containers other than the MCT Kit®: the use
of other non-original containers prevents photothermal
conditioning and therefore makes the treatment
useless. In addition, it may damage the unit tray.

EN
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MCT® UNIT
Improves biological autologous
material through the controlled
emission of 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.

EN
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02. 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
Infrared sensor (contactless)
Increase rate
0.1ºC
Refrigeration
Forced air
Tray
Removable and with locking
system
Maximum energy emission at 620nm (red)
12 joules/min.
Maximum energy emission at 530nm (green)
10 joules/min.
Maximum energy emission at 467nm (blue)
10 joules/min.
Maximum energy emission at 591nm
(amber)
7.5 joules/min.
Maximum energy emission at 850nm
(infrared)
10 joules/min.
Radiation emission
Pulsed
Screen
7” colour LCD, capacitive touch
screen
CPU
Arm®, Cortex®-M7, 1Gbit NAND.
Firmw. Updated by USB 2.0
Approximate dimensions
300mm (l) x 300mm (w) x 400mm
(h)
Approximate weight
8kg / 18lb
Power supply
230 VAC, 50 Hz, 150W
Fuse
3.15A-250V
Maximum power
400W
Altitude
2000 m
Pollution degree
Type 2
Storage and transport conditions
0ºC-50ºC
(32ºF-122ºF)

EN
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EN
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03. 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 of
Platelet Rich Plasma to obtain a
higher concentration of ATP and
growth factors, with a more
prolonged and physiological
release. It lasts 15 minutes and
applies four degrees and 1 J/Cm2
of red light.
Protocol #2. Cells stimulation.
Photo-thermal stimulation for
metabolism and a greater synthesis
of ATP. It lasts 10 minutes and
applies 1 J/Cm2 of red light.

EN
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Protocol #3. Exosomes.
Photo-thermal modulation for the
stimulation of exosomes
releasing.

EN
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04. PROCEDURE
When the device is switched on, the software is loaded,
and a start screen appears where the treatment can be
selected.
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.

EN
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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.

EN
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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.

EN
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05. 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. We recommend the use of disinfectants
for medical devices such as Instrunet Superficies.
To clean the fans, suck the dust with an electronic
vacuum cleaner or carefully wipe the outer blades with
a damp cloth.
User is responsible of proper decontamination in the
event of spillage of the sample or other hazardous
material on or inside of the equipment. Cleaning and
disinfection must be done right away. It may drip to
the bottom of the screen or exterior parts and enter the
unit and may cause damage to the component parts.
User is expected not to use decontamination or
cleaning agents that could cause a hazard as a result
of a reaction with parts of the equipment or with
material contained in it.
The manufacturer or its agent should be consulted if
there is any doubt about the compatibility of
decontamination or cleaning agents.

EN
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06. 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:
1. Screen: Allows you to change the screen
brightness with a simple intensity slider.
2. Sound:Allows you to change the software’s
volume.
3. Language: Allows you to choose between English,
French and Spanish.

EN
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4. 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:
a) select the wavelength or light color you wish to
apply (specific button)
b) adjust the intensity of each wavelength to be
employed (slider or the +/- buttons)
c) adjust the temperature value (slider or +/- buttons)
d) adjust the session time (scroll clock)

EN
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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.
5. About MCT: Information on the software version.

EN
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07. 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.
The product must be connected to an electrical
installation correctly protected and equipped with a
protective earth.
The equipment is designed to be used in basic
electromagnetic environments. The standard applied is
EN IEC 61326-1 (Electrical equipment for
measurement, control and laboratory use - EMC
requirements - Part 1: General requirements).
The equipment should only be used by medical
personnel who have read and understood this
instruction manual or have been adequately qualified
in the operation of this equipment. Non-qualified
personnel should only use the equipment for
occasional maintenance or adjustments, following the
indications of the manufacturer's authorized technical
service.
Alarms and troubleshooting:
• When the MCT® Kit® tray is not correctly
positioned or in its place, a warning screen will