Cocoon safyre User manual

User manual
Facial rejuvenation and body
contouring in a single device

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INTRODUCTION
The purpose of this manual is to provide the safyre user with the information on the instructions for use,
treatments, controls, safety precautions, installation and maintenance of the equipment, aiding use and
care of the system.
Adequate training by qualified staff is indispensable to apply treatments using this equipment.
The manufacturer provides training courses that are essential in order to be able to use the safyre
device.
This user manual includes the following information:
Safety and regulatory: Contains explanations and indications about the necessary security
measures in order to operate the safyre device.
Storage, handling and transportation: Recommendations for the storage and handling of the
product, in order to avoid damage.
Initial verification: Considerations to receive the device and list of components and accessories
safyre.
General description: Overview of the various safyre subsystems.
Installation: Explains the electrical requirements, space and environmental required for
installation of safyre device.
Operation: Explains how to use safyre.
Alerts: Description of the different alarms with counting system.
Description of procedure: safyre procedure and treatments that can be also made protocol
and contraindications.
Maintenance: It provides a detailed explanation of the procedures for cleaning and maintenance
of device and accessories.
Specifications: Contains a summary sheet with all device specifications.
Use of the safyre equipment is only authorised for people with sufficient training and
knowledge to guarantee its correct use and handling within the safety parameters
established.

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SAFETY AND REGULATORY
Regulation
The CE mark accredits compliance with the European Directive applicable to the device.
Electrical safety requisites
The safyre equipment is designed and intended for continuous operation, allowing it to operate on
universal mains voltage of 100 – 240 V, 50 – 60 Hz.
safyre is protected from electric shock by earthling protection. The unit is earthed through the
conductor on the power cable.
WARNING: In order to avoid the risk of electric shock, this equipment must only be
connected to a power grid with earthling protection. The power lines must be free of
transitory, voltage or current peaks, voltage drops or surges.
WARNING: Avoid connecting the safyre to the same electric line to which a sensitive
apparatus is connected.
There are high currents inside the equipment that may be dangerous, so no housing panel must be
removed other than by personnel authorized by the manufacturer. The safyre must never be left
unattended when switched on.
The dispositive protection device is a timed fuse with ceramic encapsulation of 5A (T5AH250V).
WARNING: The equipment has 1 fuse installed. If it blows, it is mandatory to replace it
with one that has the same rating to guarantee safety and avoid fire risk.
Electromagnetic safety requisites
safyre has been designed so it does not emit electromagnetic disturbances that may affect radio
services or the essential operation of other devices. Likewise, safyre is designed to provide adequate
immunity to offer basic safety and normal functioning in the presence of electromagnetic disturbances.

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safyre is an equipment that intentionally applies RF electromagnetic energy to perform its intended
function, marked with the symbol IEC 60417-5140 (
See regulatory marking and labelling ).
safyre requires special precautions in relation to EMC and needs to be installed and
commissioned according to the information on EMC provided. Portable and mobile RF
communications equipment may affect the safyre during its normal use.
Only the cables and accessories supplied by the manufacturer must be used. Use of
accessories, transducers and cables other than those specified may cause an increase in
emissions or a decrease in the immunity of safyre.
safyre must not be used next to or stacked up with other equipment. Should that
happen, the safyre must be observed to check its correct operation.
General warnings and precautionary techniques
1. In case of dropping one of the handpieces,
under no circumstance should you reuse it , since
it might be damaged. Contact the Technical Support.
2. If an accessory shows any kind of defect,
you should stop using it immediately and contact
the Technical Support.
3. For security reasons, before cleaning the device, disconnect the power cable from the outlet.
4. Access to the internal parts of the device should be performed by authorized service personnel.
For reparations or other information you should contact High Technology Products, S.L.
5. For a correct usage of the handpiece, make sure to handle it carefully, avoiding accidental
impacts that could damage it or reduce its effectiveness.
6. In case of accident (e.g. accidental fall of the applicator in a container of water) unplug the
device and contact our Technical Support.
7. Do not use accessories which are not original: they could damage the device and void the
warranty. High Technology Products S.L, declines all responsibility for damage caused by non-
original spare parts.
8. The scope of the device is professional aesthetic medicine; treatment should be performed
always under medical supervision, therefore it should not be used for other applications or by
unqualified personnel. Warranty is void in case of breaching this observation.
9. It is essential to take the device-training course.
10. The operating instructions must be kept near the device.
11. Check periodically that the accessories wires are in perfect condition.
12. Do not use electrical extenders for the power supply connection wire.
13. Any tampering by unauthorized personnel voids the warranty.
14. The device shall not be exposed to the elements (heat, cold, rain...).

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15. No responsibility is assumed for the misuse of the device.
16. The manufacturer and distributors will only be responsible for the safety of the product, if the
repairs, modifications and adjustments are carried out by expressly authorized personnel, and if
the device is used by qualified personnel and in accordance with the instructions.
17. The device should never be used in the presence of flammable gases or liquids.
18. Only personnel specially authorized by the manufacturer may provide technical service,
especially inside the protective covers. This includes any adjustment in the power supplies,
power amplifiers and control, since within the device dangerous electrical voltages are present.
19. For security reasons, the network cable is fitted with a plug with protective ground connection.
Use only a proper grounded AC outlet. Otherwise, this could cause damage to the appliance or
to people. If there are any specific questions, please contact our Technical Support at High
Technology Products, S.L.
20. You must only use glycerin or products and fluids specified by the manufacturer;
otherwise the warranty will be void.
Other safety requirements
IMPORTANT: For any questions on health status, pregnancy, lactation, etc., both the
person who should receive treatment and you should do it, check before starting
treatment to a specialist.
Regulation for labeling
Symbol S1 - Information
Information based on Art.13of Legislative Decree. 151/05 on 25/07/2005.
“The Implementation of Directive 2002/96/EC on the reduction of hazardous substances in electrical and
electronic device and waste wear”.
Present on the label of the technical features indicating that the product should not be disposed of as
urban waste but must be the subject of a separate collection.
If the waste is to be removed in an unsuitable way, it is possible that some parts of the product may
have potentially negative effects on the environment and human health.
In case of faulty product abuse, sanctions are foreseen.

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Symbol IEC 60417- 5333 - Information
Type BF Applicable Part.
Floating applicable parts. Not allowed to use it in combination with defibrillators.
Present on the main label the device at the bottom rear part.
Symbol IEC 60417- 5007 - Information
“ON” (power).
Present at the unit switch. It indicates that the device is on and consuming energy.
Symbol IEC 60417- 5008 - Information
“OFF” (Energy).
Present at the unit switch. Indicates that the device is off and no power is being consumed.
Symbol IEC 60417- 5134 - Information
Electromagnetic Interference.
Present in the supporting documents according to the requirements of the harmonized standard
IEC60601-1-2:2007. Electromagnetic interference may occur if the device is placed nearby some device
marked with this symbol.
Symbol ISO 7010- W001 - Information
General warning.
Present in the user interface, the appearance of this symbol during a normal usage of the device means
that you should consult the user manual before any further action.
Symbol 5.12 EN280 - Information
Symbol manufacturer.

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It indicates the manufacturer's data. Present in the main tag device at the back.
Symbol S2 - Information
Fuse.
Present on the main label of the device at the bottom rear, indicating its features.
Brand 1 – Information
Brand attesting the conformity of device to the legal obligations of the European Community directives
are applicable.
Present on the main label of the device at the bottom rear.
Technical general warnings
External Labeling of the Device - Information
Label present in the rear of the unit next to the power connector in accordance with the requirements of
IEC 60601-1 harmonized standard for the basic safety of medical electrical device. Symbols for sanitary
device according IEC980:2009 harmonized standard.
High Technology Products
S.L.
Passatge Masoliver, 24-28
Barcelona (Spain)
MADE IN SPAIN
100 – 240 V 50 - 60 Hz
350 W
SAFYRE

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Almacenamiento
Storage

Temperatura
Temperature
2ºC–50ºC

Humedad
Humidity
(Sincondensación)
(Non‐condensing)
<90%


Outer packaging labeling of the Device - Information
Label present in the outer packaging of the device in compliance with the applicable requirements of the
harmonized standard IEC60601-1 for operating conditions.

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STORAGE, HANDLING AND TRANSPORTATION
Location and transport of the device
Due to the weight of the device, safyre may cause injury if not moved with the necessary care. safyre is
designed to work with a mobile stand, although it may be used without that stand as table top
equipment.
If used as table top equipment, it must always be transported between two persons and placed on the
work table at an adequate height (approximately 1 metre from the floor) to guarantee its correct handling
and visibility.
If you attempt to transport the equipment without adequate care, the personnel may
suffer harm.
Place the equipment away from sources of heat. Keeps enough space around the device to guarantee
its correct ventilation, above all making sure
never to obstruct the ventilation grilles of any of the
panels of the device.
It is recommended that a minimum of 40cm. separation between the back of the unit and
20cm. on the sides. The device must rely on their feet (if used in desktop mode).
Work and storage conditions
In order to ensure that the safyre equipment works in an optimum way, it is recommendable to maintain
the workplace at between 18ºC and 30ºC, with a relative humidity under 80%.
For correct transport and storage of the equipment, it is recommended to keep the ambient temperature
between 2 ºC and 50 ºC.

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INITIAL VERFICATION DEVICE AND ACCESSORIES
It is very important to check your device when you receive it, in the presence of the carrier and with the
highest degree of attention, because the damage due to dropping or shocks may not be noticed at first.
Although the manufacturer has taken the utmost care in packaging, this might not be sufficient to
guarantee that the merchandise has not suffered damage.
You should check:
The material received matches the list of components and accessories herein.
The outer packaging conditions of humidity, external damage, or any abnormalities.
That each of the components and accessories are in good condition.
Keep the original packaging of the device during the first 30 days of use as changes shall
not be accepted without delivery of the equipment in the original packaging during that
period.

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List of components and accessories
DescriptionNºDescriptionNºDescriptionNºDescriptionNº
safyre device1SD electrode holder
body
1Multipolar applicator
body 2x2
1Multipolar applicator
body 3x3
1
Monopole
applicator body 70
1 Monopole applicator
facial 35
1 Massager 1 SD electrode holder
facial
1
Passive plate 1 Massager accessory Glycerin
(
dermic gel
RF)
1 Pedal 1
Guarantee
certificate
User and packaging
manuals
English and Castellan
protocols
2Display safyre1
  
Conformity
declaration
1 

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GENERAL DESCRIPTION OF THE DEVICE AND HANDPIECES
External description of the device
The safyre device is comprised of a central unit and a series of radio frequency heads, with extractable
accessories and mechanical massage. safyre also includes accessories for patient safety during the
treatment. The following is a description of the main components of the device.
TFT – Touch screen
RF accessory
connector
Passive plate
connector
Mechanical massage
accessory connector
Pedal
Accessory
cradle
Power
switch – I/O
Mains cord
socket
Air ventilation
Main view - safyre
Rear view - safyre

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Internal connector
Applicator (mechanical)
Internal connector
Applicator (electric)
Connector head
Description of the applicators and accessories
safyre includes a series of radio frequency heads, both for bodily as well as facial use, with multiple
extractable accessories, and an head to perform the mechanical massage function just as described
below.
It is essential to clean the extractable radio frequency accessories and the mechanical
massage heads using a damp cloth to avoid gel accumulation at the end of each
treatment. Also perform cleaning during the treatment if necessary.
To pay special attention to the internal electrical connection, both the accessories as
well as the base, in case remains of gel or liquids are observed during handling.
Radio frequency body head
RF body electrode holder: Base of the body radio frequency head that allows manual
connection / disconnection of the different body accessories easily and comfortably.
Connector head: Type of connection that allows connection / disconnection of the RF head to
the central unit.
Internal head connector (electrical): Type of connection (located inside the base of the head)
that connects electronically with the different extractable body accessories, guaranteeing
detection of the head and active RF emission when the connection is complete.
Internal connector head (mechanical): Centring piece (x2) that mechanically connects the
base of the head to the different extractable body accessories.
RF body electrode holder

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Extractable body accessory – multipolar 6 pins (3+3)
The 6 pin multipolar accessory for body treatments uses multipolar radio frequency technology, so the
radio frequency current circulates between the pins without the need for a passive plate.
Extractable body accessory – multipolar 4 pins (2+2)
The 4 pin multipolar accessory for body treatments uses multipolar radio frequency technology the
same way as the 6 pin multipolar accessory, so the radio frequency current circulates among the pins
without the need for the passive plate.
Extractable body accessory – monopolar 70
The monopolar 70 accessory for body treatments uses monopolar radio frequency technology, so the
radio frequency current requires use of the passive plate in contact with the body to be able to perform
the treatment.
RF emitters
Multipolar 6 pin accessory
Joint rings
Accessory connector
(Mechanical)
Accessory connector
(Electrical)
RF emitters
Joint rings
Accessory connector
(Mechanical)
Accessory connector
(Electrical)
RF emitter
Joint rings
Accessory connector
(Mechanical)
Accessory connector
(Electrical)
A
ccesorio multipolar 4 pin
Monopole
A
ccessory

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Internal connector
head (electric) Internal connector head
(mechanical)
The following details the parts that comprise the extractable accessories for body radio frequency:
Accessory connector (electric): Type of connection of the radio frequency accessories that are
electronically connected with the internal connector head (electric) located in the electrode
holder that guarantees detection of the head and the active RF emission when the connection is
correct.
Accessory connector (mechanical): Female centering piece (x2) that mechanically connects
the different extractable body accessories with the electrode holder for body radio frequency.
Joint rings: Two fixing elements that guarantee the seal tightness of the connection of
extractable accessories, mainly avoiding liquids or remains of gel entering during its use.
RF emitter/s: Applicable part in contact with the patient through which the radio frequency
energy is emitted once the electric connection of the accessories is correct (as long as the
radio frequency emission is activated).
It is very important to always guarantee a complete contact of the RF emitters with
the patient’s skin, along with a sufficient amount of gel, to avoid false contacts while the
radio frequency is activated. Guaranteeing good contact of those emitters avoids any
kind of adverse effect on the patient during application of the treatment.
Radio frequency facial head
Parts that comprise the facial electrode holder:
Joint rings
RF facial electrode holder

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Facial RF head: Base of the facial radio frequency head that allows manual connection /
disconnection of the different facial accessories easily and comfortably.
Connector head: Type of connection that allows connection / disconnection of the RF head to
the central unit.
Internal connector head (electric): Type of connection (located in the interior base of the
electrode holder) that is electronically connected with the different extractable facial
accessories, guaranteeing detection of the head and the active RF emission when the
connection is complete.
Internal connector head (mechanical): Centering piece that mechanically connects the base of
the head with the different extractable facial accessories.
Joint rings: Two fixing elements that guarantee the seal tightness of the connection of
extractable accessories, mainly avoiding liquids or remains of gel entering during its use.
Monopolar facial extractable accessory
The monopolar accessory for facial treatments uses monopolar radio frequency technology, so the
radio frequency current requires the use of a passive plate in contact with the body to close the circuit.
Parts that comprise the facial electrode holder:
Accessory connector (electric): Type of connection for the radio frequency accessories
connected electronically to the internal head connector (electric) located on the base of the
head, guaranteeing the direction of the head and of the active RF emission when the
connection is complete.
Accessory connector (mechanical): Female centring piece that mechanically connects the
different extractable facial accessories to the body radio frequency head base.
RF emitter/s: Applicable part in contact with the patient through which radio frequency energy
is emitted once the electric connection to the accessories is correct (as long as the radio
frequency emission is activated).
Facial accessory monopole
RF emitter
Accessory connector
(electric)
Accessory connector
(mechanical)

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Massage
accessory
Push button
Mechanical massage
base
Applicator connector
It is highly important to as well as guarantee a complete contact between the RF
emitters and the patient’s skin, along with a sufficient amount of gel, to avoid false
contact while the radio frequency is activated. Guarantee good contact of those emitters
to avoid any kind of adverse effect to the patient during application of the treatment.
Mechanical massage head
The following details the parts comprising the mechanical massage head:
Base of the mechanical massage head: Base of the mechanical massage head that allows
manual connection / disconnection of the massage roller, easily and comfortably.
Massage accessory: Rotational applicable (extractable) part that connects to the base of the
head and performs the body massage when that function is activated, by user interface or the
push button on the head.
Head connector: Type of connection that allows connection / disconnection of mechanical
massage head base from the central unit.
Push button: Head push button that allows activation /deactivation of the massage and
modification of the turning direction of the roller.
Mechanical massage head

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Operation of the mechanical massage head push button
Long press With massage inactive, keeping it pressed activates the rotation of the
r
oller.
(Once it is active, work without continuing to press).
Long press With the massage active, keeping it pressed stops the rotation of the roller
(pause the treatment).
Short press With the active massage, a short press changes the roller turning direction.
The push button must not be kept pressed during use of the mechanical massage
head.
The aim of the push button is to start or stop the treatment and to change the
turning direction (if considered necessary), without the need to use the user interface,
easily and comfortably.
The mechanical massage head is not used with the pedal.
Accessories
Pasive plate: The passive plate is the neutral element that is used in contact with the body in treatments
using monopole radio frequency, to facilitate passage of the current provided by the heads.
The facial and body monopole accessories require a passive plate for normal operation.
It is important to make sure this accessory is in perfect contact with the patient’s body
during the whole treatment to avoid defective current contact. Guaranteeing good contact
of those emitters avoids any kind of adverse effect on the patient during application of the
treatment.
Surface in contact
with the patient
Passive plate

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Pedal: Keeping the pedal continuously pressed enables radio frequency emission by the different
heads to perform the treatment. It is recommendable to perform the RF treatments with the pedal.
With the equipment in play mode, the radio frequency emission is activated by keeping
one’s foot pressed on the pedal.
Both when placing as well as on lifting the heads from the treatment area on the patient, it
is very important that the radio frequency emission is disabled (pedal not pressed). This
avoids current false contacts, guaranteeing a safe treatment.
Pedal
Pedal activation

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INSTALLATION AND START UP
Placement of the device in the support
The equipment has a cradle for accessories located on the rear (see Exterior description of the
equipment). The accessories must always be placed in their cradle, when starting up the equipment and
when its use has finished.
The remaining accessories must be kept duly in their respective boxes to avoid blows and
falls that may give rise to malfunctioning of the equipment. Never use a defective head. In
such a case, contact with the technical service.
Connecting accessories and applicators to the equipment
The following scheme details connection of the different accessories and heads to the SAFYRE
equipment, before beginning the treatment:
Mechanical massage
head connector
RF head
connector
Passive plate
connection
Pedal connector