MCT Unit User manual

MCT® Unit
USER MANUAL

- 2 -
CONTENTS
01. WHAT IS MCT® AND WHAT IS IT FOR?...........................- 4 -
02. DEVICE ........................................................................................................- 5 -
03. TECHNICAL SPECIFICATIONS................................................. - 6 -
04. PROTOCOLS .......................................................................................... - 8 -
05. PROCEDURE........................................................................................- 10 -
06. OBSERVATIONS AND MAINTENANCE...........................- 16 -
07. DEVICE SAFETY MEASURES:..................................................- 17 -
08. SYMBOLS............................................................................................... - 19 -
10. DECLARATION OF CONFORMITY .......................................- 21 -
ESPAÑOL ...............................................................................................................- 22 -
11. QUÉ ES MCT® Y PARA QUÉ SIRVE...................................- 23 -
12. DISPOSITIVO........................................................................................- 24 -
13. ESPECIFICACIONES TÉCNICAS............................................- 25 -
14. PROTOCOLOS ....................................................................................- 27 -
15. PROCEDIMIENTO.............................................................................- 29 -
16. OBSERVACIONES / MANTENIMIENTO..........................- 35 -
17. MEDIDAS DE SEGURIDAD:........................................................- 36 -
18. SIMBOLOS.............................................................................................- 38 -
19. GARANTIA .............................................................................................- 39 -
20. DECLARACIÓN DE CONFORMIDAD................................. - 40 -

- 3 -

English
- 4 -
01. WHAT IS MCT® AND WHAT IS IT
FOR?
MCT® is the first system for the photothermal
activation of autologous materials.
MCT® enables existing regenerative medicine
treatments to be activated simply and quickly. Through
the application of electromagnetic (light and infrared)
and thermal (temperature) energy, it activates the
autologous materials.
MCT® enhances the beneficial properties of
autologous materials, such as platelet-rich plasma
(PRP) and all of its derivatives.
Regenerative medicine protocols usually involve two
processes: obtaining an autologous material and
applying it. MCT® adds a simple intermediate step:
activating it. MCT® conditions conventional autologous
materials and transforms them. They have greater
therapeutic power. The clinical benefits are improved,
along with the therapeutic results that can be obtained
through their use.

English
- 5 -
02. DEVICE
The MCT® System consists of two devices: MCT® Unit
and MCT® Kit®:
MCT® UNIT
Activates biological autologous
material through the controlled
emission of electromagnetic
energy.
MCT® KIT®
Device that stores the autolo-
gous material to be activated.
Patented and developed with
geometry and chemical compo-
sition specific to the effective
photothermal activation of auto-
logous materials.

English
- 6 -
03. 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
Ambient operating conditions
3.0ºC-30.0ºC
(37ºF-86ºF)
10% to 85% with no condensation
Altitude
2000 m
Pollution degree
Type 2
Storage and transport conditions
-5ºC-60ºC
(23ºF-140ºF)
10% to 85% with no condensation

English
- 7 -

English
- 8 -
04. PROTOCOLS
The device has two pre-set protocols for PRP activation
and a free (Custom) programme so its use may be
personalised depending on the specific needs of each
treatment.
Protocol #1. PRP. Growth factors.
Photothermal activation of
platelet-rich plasma to obtain a
greater concentration of growth
factors.
Configuration : 4ºC/15 minutes
Red 5,6J/7
minutes
Protocol #2. Cell metabolism.
Photo activation to stimulate the
cell metabolism and achieve
improved ATP synthesis.
Configuration : Red 5,6J/ 7
minutes.

English
- 9 -
Protocol #3. Custom Programme.
This programme allows the
session to be freely configured
so personalised protocols may
be developed.

English
- 10 -
05. PROCEDURE
When the device is switched on, the software is loaded
and a start screen appears where the treatment can be
selected.
Open and load the MCT® KIT® (with the autologous
material inside) onto the MCT® UNIT’s tray (see MCT®
Kit® instructions).
Reposition the tray in its specific place in the MCT®
UNIT. Start the configuration for the treatment you wish
to perform.

English
- 11 -
Select the desired preconfigured programme: PRP
(growth factors), PRP (cell metabolism stimulation), or
CUSTOM.
By selecting any of these preconfigured programmes,
the energy parameters that will be applied are loaded
automatically and the MCT® UNIT will show the
session screen directly.

English
- 12 -
On the other hand, if you select the CUSTOM
programme, you must manually configure all light and
temperature parameters:
1. select the wavelength or light colour you wish to
apply (specific button)
2. adjust the intensity of each wavelength to be
employed (slider or the +/- buttons)

English
- 13 -
3. adjust the temperature value (slider or +/- buttons)
4. adjust the session time (scroll clock)
Below the session time you will see the total energy (J)
to be applied depending on the configuration set.

English
- 14 -
By pressing Start, the MCT® UNIT will begin the
session and change to the specific screen. When the
MCT® Kit® tray is not correctly positioned or in its
place, a warning screen will indicate that the session
cannot be started until the incident is resolved.
Once started, a timer will show the session’s remaining
time in addition to the settings for all variables.
An acoustic warning will indicate the session has ended
and the MCT® KIT® may be removed from the MCT®
UNIT’s tray.

English
- 15 -
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.

English
- 16 -
06. OBSERVATIONS AND
MAINTENANCE
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.
4. About MCT: Information on the software version.

English
- 17 -
07. DEVICE SAFETY MEASURES:
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. To clean the fans, either blow the dust
away using compressed air, suck up the dust with an
electronic vacuum, or wipe away the dust with a damp
cloth. Never spray water or detergent directly on the
MCT Unit. It may drip to the bottom of the screen or
exterior parts and enter the unit and may cause
damage to the component parts. Do not plug the unit
into the wall outlet until the moisture from cleaning has
evaporated.
User is responsible of proper decontamination in the
event of spillage of hazardous material on or inside
of the equipment. 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.
Usage: 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

English
- 18 -
correctly protected and equipped with a protective
earth. The equipment should only be used in interior
spaces by authorized and qualified staff. Non-qualified
staff should only use the equipment for occasional
maintenance or adjustments.
Safety: Do not operate any appliance with a damaged
cord or plug. The power cable should meet the
following ratings: 16A 250V, H05VV-F, 3x0,75 mm2.
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 photothermo
activation and therefore makes the treatment useless.
In addition, it may damage the unit tray.

English
- 19 -
08. SYMBOLS
Caution
Risk of electrical shock
Consult instructions for use
CE marking
Manufacturer
Reference
Serial number
Alternating current
Fuse
IK06
Impact rating

English
- 20 -
09. 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.
Warranty does not cover defects or damage resulting
from improper maintenance, inadequate power
supply, negligence or incompetence, as well as faults
or damage to parts subject to standard wear.
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.