Sedatelec Premio 10 moxa User manual

YOUR USER GUIDE
Must be kept with the appliance
English

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Congratulations for choosing the Premio 10 moxa.
Heat stimulation is a valuable therapeutic aid.
Moxibustion, and its application to certain acupuncture points,
is a major resource in the practitioner’s arsenal.
Daily use of the Artemisia moxa in your practice poses a
number of problems, with toxic fumes and the persistent odor being the
most troublesome both for the therapist and the patient.
This has led some of you to avoid using a technique that provides a
wealth of results.
Today, after many years of research, we have developed a
device that reproduces the energy characteristics of Artemisia moxa as
closely as possible, without the drawbacks.
Thanks to this high quality device, which complies with the up
to date medical standards, you will have all of the applications,
sensations and, of course, results that you expect. And you can
rediscover ancient applications, or develop new ones...
Thierry GARABOUX,
Chairman

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Table of contents
General information__________________________________________ 5
The spectral concordance of the Premio 10 moxa and burning artemisia 6
Indications, safety practices & contraindications ___________________ 7
Description of the Premio 10 moxa ______________________________ 8
Electrical safety instructions ___________________________________ 9
Thermal safety instructions ___________________________________ 10
Applicable norms ___________________________________________ 12
The classifications___________________________________________ 13
Thermal application _________________________________________ 15
Application without the concentrator ..................................................... 15
Application with the concentrator........................................................... 17
Warranty - breakdowns – Recycling procedures___________________ 20
Appendix 1: Heat stimulation _________________________________ 21
Appendix 2: Moxibustion in Traditional Chinese Medicine __________ 24
Appendix 3: Blackbodies and the infrared emission of the Premio 10 moxa
_________________________________________________________ 26
Appendix 4: Technical specifications ____________________________ 31
Appendix 5: Electromagnetic compatibility and manufacturer’s statement
_________________________________________________________ 32
Moxibustion made simple ....................................................................... 34
Warning: Use carefully. May cause serious burns. Do not use over
sensitive skin areas or in the presence of poor circulation. The
unattended use of the PREMIO 10 moxa by children or incapacited
persons may be dangerous. Do not heat the acupuncture needles – risk
of serious burns.

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To use your Premio 10 moxa as safely and comfortably as possible, we
recommend that you read its user manual and the user manual for the
power supply thoroughly before the first use.
We have designed this guide to help you in your daily practice, so please
don't hesitate to consult it regularly... and to let us know what you think,
so we can improve it and make it even more useful for you.
Please note that Sedatelec can only be held responsible for the safety,
reliability and performance of the appliance if:
-the appliance is used in compliance with the description in the
User Guide,
-the accessories used comply with the references cited in the
User Guide,
-any assembly, adjustments, modifications and repairs of the
appliance that should prove necessary have been carried out
only by a person expressly authorized to do so by Sedatelec.

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G
GE
EN NE ER RA AL L I IN NF FO OR RM MA AT TI IO ON N
Your Premio 10 moxa is an appliance that emits infrared radiation at a
spectrum that is particularly close to that emitted by a burning roll of
Artemisia.
It therefore lets you provide efficient additional therapy for a number of
pathologies, through application of very specific “heat” to acupuncture
points, areas of pain or reflex points.
The total absence of harmful or bad-smelling fumes and ashes, and the
ease of use and handling of the appliance with a single button provide
general comfort when using for you and your patient.
Because of the identification of the heat with “traditional” moxa, you
will immediately have all of the sensations you expect as well as the
clinical results.
Moxibustion once again becomes a therapy providing great satisfaction
for the happiness and health of your patients, now that it has been freed
of the restrictions and inconveniences of combustion!

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T
TH
HE E S SP PE EC CT TR RA AL L C CO ON NC CO OR RD DA AN NC CE E O OF F T TH HE E P
PR
RE EM MI IO O
1 10 0 M
MO OX XA A A AN ND D B BU UR RN NI IN NG G
A
AR RT TE EM MI IS SI
IA A
The Premio 10 moxainfrared emitter has been specially designed so its
emission spectrum is as close as possible to that of the end of a roll of lit
Artemisia, without the ash (moxa-like, see appendix 3).
The quality of the emission spectrum reproduces the exact stimulation
obtained with a roll of Artemisia, in the same wavelength proportions.
Whether for direct use or with other components between the
Premio 10 moxa and the skin.
This is important, as it means that you stimulate each group of
cutaneous and deep receptors according to specific sensitivity, as with
traditional Artemisia.
Other sources of heat can over- or under-stimulate some types of
receptors, disturbing the patient’s reaction, as there may be a sharp
burning sensation before the energy can penetrate, or even no sensation
of heat even though the deep tissue is being damaged.
Even if moxibustion is still not fully understood, coming this close to the
spectrum of Artemisia, which has been in use for over 3000 years,
means the Premio 10 moxa guarantees safety and efficiency.

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I
IN
ND DI IC CA AT TI IO ON NS S,
,
S SA AF FE ET TY Y P PR RA AC CT TI IC CE ES S &
&
C CO ON NT TR RA AI IN ND DI IC CA AT TI IO ON NS S
Indications
Your Premio 10 moxa is particularly efficient for heat therapy of a zone or
point:
-in acupuncture (moxibustion)
-on reflex points
-in auricular therapy
-locally on areas of pain
Safety indications
There are no specific contraindications for the Premio 10 moxa, apart
from those for localized heat (risk of burning).
As with every thermal appliance, it must be handled with care, in
particular with respect to the hot metal parts.
Its use as part of medical treatment requires skilled personnel with
knowledge of the medical indications, contraindications and risks
connected with use of localized heat. The practitioner must always remain
attentive to how the patient feels during the treatment.
Contraindications
In particular use on people with diminished heat sensitivity or unable to
communicate what they are feeling is not advised.
The sensitive zones (mucous membranes, eyes, damaged skin, abdomen of
a pregnant woman, etc.) and those zones anatomically close to sensitive
structures (major blood vessels) are to be avoided.

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D
DE
ES SC CR RI IP PT TI IO ON N O OF F T TH HE E P
PR
RE EM MI IO O
1 10 0 M
MO OX XA A
The Premio 10 moxa is a blackbody thermal infrared emitter (see
appendix 3) that is mains operated.
ON/OFF button (O/I)
Power cable
Infrared
emission
Safety main
power supply
Concentrator
Adaptors
Thermal
diffuser

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The Premio 10 moxa comes with an accessory, the Concentrator, 4 sector
adaptors, an operating guide and a storage bag.
The bag contains a small pouch to hold the Premio 10 moxa, and a large
one for the power supply, cord, operating guide, etc. This means you can
store the appliance for transportation to your patients, if needed.
Once the Premio 10 moxa has been unplugged, it can be stored in its bag.
The Premio 10 moxa comes with an adaptor that clips beneath the power
supply case. The 4 adaptors mean you can plug the appliance in, regardless
of the country you happen to be in.
To change the adaptor,
1 – Press the middle of the power supply box where the
adaptor is clipped on.
2 – While pressing, pull the adaptor upwards to remove it
from its housing.
3 – Replace the adaptor with the one you need. A “click”
tells you the new adaptor is properly in place.
Europe UK US Australia

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ELECTRICAL SAFETY INSTRUCTIONS
As the appliance is not sealed, never immerse it in liquid. Never use it in a
flammable environment.
Never use the Premio 10 moxa during a thunderstorm. Channeled
electrical discharges are uncontrollable and dangerous for both the
appliance and the users.
Be sure to only use the 110V/240V, 50/60 Hz medical power supply box
which supplies 5V between 1.5 and 3 A, or if not, a protected 5V external
battery with an isolating cover, which is not connected to the mains
whilst using Premio 10 moxa and does not supply more than 3 A.
Caution, it must be a medical power supply unit. Otherwise, you could be
exposed to severe risks.
The power supply box must always be accessible so that the device can
be disconnected from the mains.
Never leave the unconnected power cord outside of its box.
THERMAL SAFETY INSTRUCTIONS
When in use, some parts of the Premio 10 moxa become hot.
This means basic care is needed when handling:
-do not use the Premio 10 moxa in the presence of flammable
gas (oxygen, alcohol or ether vapors, etc.)
-Stop the device before cold cleaning
-after cleaning, wait until the disinfectant has totally evaporated
before turning the appliance on
-do not touch hot areas: metal parts of the diffuser and
Concentrator.
-The temperature of the front part between the 2 symbols
can exceed 48°C, after 5 minutes of continuous operation.

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However, you can continue to use the device by holding it by
the rear part.
The insulating end of the Concentrator significantly
reduces the risk of burns, in case of accidental contact.
The Concentrator is safe to handle, thanks to the white
insulating ring.
If the appliance is brought to a minimum of 2.5cm from the skin without
the Concentrator in place, or to a minimum of 0.5cm with the
Concentrator, the skin will not be exposed to temperatures exceeding
45°C, even in the case of prolonged exposure.
In general, make sure the patient is ready and able to inform you if the
sensation of heat becomes too strong.
An electronic safety device shuts the appliance off in the event of
accidental overheating of the emitter (confined emission).
0,5 cm
2,5 cm

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APPLICABLE NORMS
- NF EN ISO 14971: 2013
Medical devices - Application of the management of risk with medical
devices
EN 60601-1: 2006 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2013)
Electro-medical devices - Part 1: General basic safety requirements and
essential performance
- IEC 60601-1-2: 2014
Electro-medical devices – Part 1-2: General basic safety requirements and
essential performance – Associated norm: Electromagnetic compatibility
– Requirements and testing
- IEC 60601-1-4: 1999
Electro-medical devices – Part 1: General safety requirements - 4.
Associated norm: programmable electro-medical systems
- NF EN 1041: 2008
Manufacturer information on medical devices
- ISO 15223-1:2017
Medical devices - Symbols to be used with labels, labeling and
information to provide concerning medical devices - Part 1: General
requirements
- NF EN 980: 2008
Symbols to be used in the labeling of medical devices.
- NF EN ISO 7010 : 2013
Graphic symbols – Safety colours and safety signs – Registered safety
signs

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THE CLASSIFICATIONS
The Premio 10 moxa is a IIa medical appliance according to directives
93 /42 EEC and 2007/47/EC.
Explanation of the symbols used on the labels
The appliance sales reference
Serial Number
Consult the appliance operating guide
Dispose of electronic waste (Directive 2002/96/CE
regarding WEEE)
EC label ensuring compliance with directives 93/42/EEC
and 2007/47/EC
Warning: Hot Area For indoor use
Danger, optical radiation: Infra-red emission, avoid staring
directly at the source.
Manufacturer Manufacturing date
Electrical protection class 2, double insulation
SN
REF

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TURNING THE APPLIANCE ON /OFF
When you plug-in the Premio 10 moxa, a green
diode lights up on the power supply case,
confirming it is working properly.
Press the O/I button (an orange diode lights up
on the Premio 10 moxa). Wait about 5 seconds
until the emitter reaches operating
temperature.
Pressing again stops emission.
You do not have to turn off the
Premio 10 moxa to move from one
zone to another. However, as heating does not take long, there is no
point in leaving it on when it is not in use.
Turning the appliance on and off can be done with or without the
Concentrator attached.
The Concentrator can be added or removed at any time, using basic care
if it is very hot.
The Premio 10 moxa is programmed to automatically stop after 10
minutes of uninterrupted operation. The appliance can be turned back on
immediately.
Orange
diode
O/I

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THERMAL APPLICATION
Operational in a few seconds,
the Premio 10 moxa lets you
-heat up an area of cm²,
-or, with the Concentrator, focusing the radiation on specific
body or ear points: the “thermal needle” effect.
To treat an area, sweeping the surface is apparently preferable to a point-
by-point approach, to obtain a more homogenous effect and to avoid
vascular reactions that could impede or attenuate the overall effect
expected.
The time of application varies depending on the points being treated, the
affliction, and the condition of the patient’s health, etc.
It can be from a few seconds to several minutes. The number of treated
points is generally low (from 1 to 5).
Your clinical experience with moxa is immediately applicable using the
Premio 10 moxa.

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APPLICATION WITHOUT THE CONCENTRATOR
Just as you would with a roll of moxa, bring the appliance close to the skin
while holding it perpendicular above the area or point to be stimulated,
without bringing it into contact (risk of burns).
After a few seconds, and depending on the sensation of penetrating heat
that your patient reports, move it away then bring it back, a few times; to
extend this sensation and achieve your therapeutic objective depending
on your usual clinical practice.

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APPLICATION WITH THE CONCENTRATOR
The Concentrator focuses the energy on a reduced area, when you wish
to stimulate a precise point.
This is useful with the ear in particular (auricular therapy), and with some
parts of the body.
Your patient will describe a sharp feeling of deep heat penetration after a
few seconds, and this is where the term “thermal needle” comes from.

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INDIRECT APPLICATION
The Premio 10 moxa can of course be used for indirect moxibustion using
a filter such as salt, garlic, ginger, or clay, etc, as with a roll of moxa.
You can also interpose a film or fabric, or spread an adapted balm onto
the zone or point.
You then get the benefits of indirect moxibustion, attenuation of the
cutaneous temperature, influence of the specific spectral filtering
connected to the interposed product, the physiological effect of the
active substances of the product used and therefore absorption increased
through application of heat…

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DISINFECTION –MAINTENANCE
If the Concentrator comes accidentally in contact with the patient’s skin,
we recommend it be cleaned using a wipe and a traditional clinical
cleaner before future use.
This must be done with the appliance off and reasonably cool, but does
not require removal of the Concentrator. Do not use ether or any
flammable product.
Reminder: make sure you let the disinfectant evaporate, if necessary,
before turning the appliance back on.
The Premio 10 moxa does not require other specific maintenance.
Make sure no object comes in direct contact with the infrared emitter
through the appliance’s orifice.
There is no risk of electric shock for the user in this case, but the emitter’s
filament may be severely damaged.
To ensure all of the long infrared is emitted, which is an important part of
the moxa effect, we cannot interpose a protective screen (see Blackbody
and infrared emission of the Premio 10 moxa, appendix 3).

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WARRANTY -BREAKDOWNS –RECYCLING PROCEDURES
The Premio 10 moxa is guaranteed 2 years in total (excluding the cord). If
the appliance breaks down during this period, please return it to us for
inspection. We will then either repair or replace your appliance.
This warranty does not cover deterioration or faults resulting from use,
operation or handling that does not comply with normal use as defined in
the operating guide.
If there should be a problem when using the Premio 10 moxa, please
make sure the power supply is properly plugged in to a working socket,
and the indicator light is on (green diode).
If pressing the O/I button does not turn the emitter or orange diode on,
talk to your retailer or return the appliance (in the box or sufficient
protection for transport) to Sedatelec.
For safety reasons, never attempt to repair, or handle the infrared
emitter, and never dismantle the appliance yourself.
When disposing of the Premio 10 moxa, as it includes electronic
components, please respect the applicable regulations for your region.