User manual

Mesotherapy and Carboxytherapy Gun

"Few, rarely, on the right place…"

Dr. PISTOR

Made and distributed by :

BFP Electronique
Pôle Technologique de Vimenet
48 100 MONTRODAT
 +33 (0)4 66 32 44 99
 +33 (0)4 66 32 45 03 0459
 bfp.electronique@wanadoo.fr
CONCERTO - Rev. 08 – EN- 07/03/2018 Page 2/34
 TABLE OF CONTENTS
1 Preamble.................................................................................................................................................... 4
1.1 Intended use ...................................................................................................................................... 4
1.2 Contraindications and/or precautions .............................................................................................. 5
1.3 Side effects ........................................................................................................................................ 6
1.4 Warnings and safety notices ............................................................................................................. 9
1.5 Identification and manufacturer ..................................................................................................... 10
1.6 Labels and symbols .......................................................................................................................... 11
2 Device ...................................................................................................................................................... 12
2.1 Components and device .................................................................................................................. 12
2.2 Physical characteristics .................................................................................................................... 14
2.3 Performances .................................................................................................................................. 14
2.4 Installation ....................................................................................................................................... 15
3 Instructions for use .................................................................................................................................. 18
3.1 Start-up ............................................................................................................................................ 18
3.2 Doing a treatment ........................................................................................................................... 19
3.3 Shutdown procedure ....................................................................................................................... 25
3.4 Configuration ................................................................................................................................... 25
3.5 Battery (if applicable) ...................................................................................................................... 27
4 Cleaning and maintenance ...................................................................................................................... 27
4.1 Cleaning and/or disinfection ........................................................................................................... 27
4.2 Maintenance, service, transport and warranty conditions ............................................................. 28
4.3 Possible problems............................................................................................................................ 29
4.4 Disposal of hazardous material ....................................................................................................... 29
5 Technical description ............................................................................................................................... 29
5.1 Environmental conditions ............................................................................................................... 29
5.2 Electromagnetic compatibility......................................................................................................... 30

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1 PREAMBLE

Concerto is an injector unique in the world which allows to his user to do injections of solutions
(mesotherapy drug solutions), or injectable gas (carboxytherapy). The CO2 induces a vasodilatator effect of
the blood vessels which increases the blood supply in tissues and increases the local oxygen pressure (Bohr
effect). Carboxytherapy can also induce angiogenesis and increase the lymphatic drainage.
The switch from one technique to the other can be operated easily and quickly, as described below.

Before any use of the device, it is essential to read attentively the user manual.

1.1 INTENDED USE

The device is intended to be used by physicians on grown patients.

Frequently used functions

The device can be used with a needle, a syringe, a short tube or a long tube. The different treatment
programs are MESO, EXPERT, FILLER and CARBOX. These different modes allow to set the used
components, the volume and the depth injection. An OPTION menu allows to configure the device.

Therapeutic indications

Even if Concerto is made to answer to all the daily needs injections, Concerto is only the extension of the
physician's hand, who by acting commits to be informed of the nature and the effects of the products he
chooses to inject.
Thereby, the Concerto cannot be responsible for the quality and the efficiency of the injected products.

Mesotherapy

The Concerto is indicated for mesotherapy which is a medical technique which consists of cutaneous
injection of drug solutions. The indications depend of the drugs or medical devices injected.

The use of the device is covered for drugs or medical devices with an indication of mesotherapy for which
their use is covered. Drugs or medical devices must be used in combination with Concerto according to the
same administration conditions recommended by their indication of marketing authorization or medical CE
in terms of dose to be administered, patient population, pathology and symptoms, depth, treatment areas,
treatment frequency, and type of injection. This means that the injection of products which do not have a
marketing authorization or a CE marking in mesotherapy that is compatible with the use of Concerto and
under conditions which do not comply with those covered by their indication, is not covered and is the sole
responsibility of the practitioner. The use of Concerto is reserved for physicians who can justify that have
received training in the practice of mesotherapy. The practitioner must also take into account
contraindications and side effects related to the products administered before any treatment. The
practitioner must finally seek the informed consent of the patient before any treatment.

Carboxytherapy
Carboxytherapy is a medical technique which consists of cutaneous injection of medical carbon dioxide
(CO2).
Carboxytherapy is indicated in the following cases:
- Treatment of chronic wounds of tibia and foot with localized hypoxia (involving diseases of the
arterial trunks, chronic venous insufficiency and alterations of glucose metabolism) for which a hyperbaric
oxygen therapy is unavailable or ineffective

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The chronic wounds carboxytherapy treatment must be done as a complementary therapy to the standard
treatments for chronic wounds (debridement, antibiotic therapy, dressings).

Chronic wounds treatment must be performed at the rate of 2 treatments per week, spaced 2 to 3 days, for
6 weeks.

Only sterile medical CO2 can be injected.

The device is only the extension of the physician's hand, who by acting commits to be informed of the
nature and the effects of the CO2.

Intended treatment areas

Mesotherapy
The device is intended for the injection of drugs or medical devices. Treatment areas depend on the
product injected and the pathology: refer to the manufacturer's instructions for each injected product.

Carboxytherapy
The device can inject sterile carbon dioxide subcutaneously in the skin to treat chronic wounds of tibia and
foot (injections are made in the thighs and the lower leg in the vascular axes, and around the wound).

1.2 CONTRAINDICATIONS AND/OR PRECAUTIONS

Mesotherapy

Treatment by the Concerto is contraindicated in the following cases:

- Allergies to injected product
- History of hypertrophic scar
- Bleeding abnormalities and taking anticoagulant medication in the days prior to and following the
mesotherapy session
- Thrombosis
- Pregnant women, lactating women
- Autoimmune diseases
- Epilepsy
- Diabetes
- Bacterial or viral infection
- Inflammatory pathology of the skin in acute phase
- BMI>30 kg/m²
- Children
- Taking drugs that affects the cardiovascular system
- Renal and/or hepatic and/or cardiac pathology
- Lupus
- Acquired immunodeficiency syndrome
- Cancer and chemotherapy treatment
- Damaged skin
- Treatment of the head of the fibula
- Treatment of the lateral malleolus
- Presence of a side effect of a previous mesotherapy session
- Injection of corticosteroids
- Pacemaker
- Patient who does not support injections

The physician by acting commits to be informed of the nature and contraindications of the injected
products. The injected products contraindications must be reviewed and respected. Thereby, the Concerto
cannot be responsible for the failure to observe the manufacturer instructions of administered products.
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Carboxytherapy

Treatment by the Concerto is contraindicated in the following cases :

- Recent myocardial infarction
- High blood pressure
- Active thrombophlebitis
- Gangrene
- Infections
- Epilepsy
- Children
- Pregnant women
- Lactating women
- Pacemaker
- Respiratory insufficiency/disease
- Renal insufficiency/disease
- Cardiac insufficiency/disease
- Hepatic insufficiency/disease
- Anemia
- Drugs inhibitors of carbonic anhydrase
- Phlebitis
- Hypertension
- Anticoagulant drugs
- Coagulation disorders
- Stroke
- Malignant wound
- Damaged skin
- Patient who does not support injection
- Side effect presence of an earlier session of carboxytherapy

The physician by acting commits to be informed of the nature and contraindications of the injected sterile
medical CO2.

1.3 SIDE EFFECTS

The physician by acting commits to be informed of the nature and side effects of the injected products by
consultation of the instructions manufacturer of the products concerned. Thereby, the Concerto cannot be
responsible for the side effects of injected products and CO2.

Mesotherapy

Common and transient side effects of mesotherapy :

- Pain (can be due to the puncture or product injected)
- Inflammation
- Irritation
- Bleeding
- Small haematomas (due to poor practice)
- Slight sensation of itching or burning 5 minutes after injection
- Hyperaesthesia or hyperalgesia
- Vomiting
- Diarrhea
- Edema
- Erythema (due to the product injected): can occur during the session or a few minutes after

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Effects due to injected products:
- epigastralgia: pain in the abdomen that can occur in patients with gastric ulcers or pancreatitis
- nausea

Effects due to the route of administration:

- bruising
- discomfort

Effects due to poorly technique:

- scars: can occur if the nappage technique is poorly controlled
- hematoma
- paresthesia (disturbance of sensitivity)

Rare effects:
- allergic reactions to injected substances: redness, swelling and discomfort
- infections (in particular by mycobacteria) due to bad handling which does not comply with good hygiene
practices
- necrosis (due to injected products)
- thickening of the skin (reaction cellulitis due to too much injected volume which may take several weeks
to reabsorb)
- subcutaneous nodule (due to poor practice)
- scars (due to poor practice)
- sweating, pallor, malaise
- induration
- lymphadenopathy
- Depigmentation of the skin or urticaria may occur and last for several months but their severity is low

Rare side effects due to injected products or poor practices:

- lichenoid eruptions (skin rash)
- induction of psoriasis
- urticaria
- systemic lupus erythematosus
- panniculitis
- acromy
- atrophy
- granuloma

To avoid pain, the skin can be tight or pinched during injections. In addition, an anesthetic cream may be
used before treatment, taking care to avoid any reactions that may occur with the product used for the
treatment.

If the diameter of the needle is smaller, the chance of bleeding the patient and cause pain with the
puncture are less.

To reduce the risk of nerve or vascular damage, the depth of injection must be limited to 4 mm in the
dermis. The injection depth of 10 mm must only be used in patients with adipose morphology (highly
developed adipose tissue) in the lower back for lumbar pathologies to avoid nerve and vascular lesions. 10
mm injections must be used with caution. In addition the head of the fibula should not be treated with the
guns of the mesotherapy range to avoid reaching the sciatic nerve. The lateral malleolus must also not be
treated with the gun.

It is important to monitor the face of the patient during injections, to see its reactions and if these are well
supported. If the patient has a pain rictus, the doctor must revisit his gesture. It is necessary to proceed in
this way: the skin is penetrated with the needle, the reaction of the patient is immediately observed and if
there is no pain, keep the trigger button pressed in order to inject. If pain occurs, the trigger button must

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be released so that the needle retracts, then move the needle to inject a few millimeters away. Otherwise,
the injection may be painful and be followed by a hyperalgesic period.

The mesotherapy session must always be practiced the patient lengthened to limit the possible decreases
in blood pressure or the neurovegetative reactions (sweating, pallor, small temporary discomfort). If the
patient feels discomfort during treatment, the treatment must be discontinued.

To avoid the risk of necrosis, corticosteroids must not be injected in mesotherapy.

In case of intervention in a muscle, place the needle in contact with the skin and not away in order to not
surprise the patient whose muscle could contract and make the introduction of the needle painful. The
realization of a skin fold can allow to sting in the dermis and not in the muscle.

To prevent bruising from appearing after the session, haemostasis must take place. This can be achieved by
local compression with the hand or the patient's own weight. It is also possible to put a non-allergenic
compress maintained by plaster but it must remain in place only a few minutes so it must not be forgotten
to warn the patient to remove it. The application of the compress also helps prevent friction with clothing.

The practitioner should be careful not to scrape the skin with the needle between 2 injections. The nappage
mode is limited in depth as the injection speed increases to limit this risk.

To avoid necrosis, injections of largactil must be sufficiently diluted. In addition, corticosteroids used is not
allowed in mesotherapy. Non-steroidal anti-inflammatory drugs should be diluted and should not be
injected as a strict papule (at the border between the dermis and the epidermis). To avoid
lymphadenopathy, do not inject doses greater than 10 mL in the treatment of lipodystrophy.

Treatment of an area that has just been treated with mesotherapy should be avoided until full healing of
the puncture points.

WARNING: To limit the occurrence of side effects, do not combine several products
to be injected during the same treatment session.

Carboxytherapy

The physician by acting commits to be informed of the nature and side effects of the sterile medical CO2
injected.

Carboxytherapy side effects which can occur are:

- Mild pain (during injection): rarely persists more than 72 hours
- Numbness, tingling
- Hematomas caused by stings
- Crackling sensation caused by a local emphysema (dissipated after 30 minutes to 1 hour, very rarely
dissipated after 10 days)
- Mild bruising or contusions (dissipated after 5 to 10 days)
- Erythema, redness (spontaneously dissipated)
- Heat sensation (dissipated after 10 to 20 minutes)
- Edema (usually dissipate within hours, in rare cases they can be extended from 24 to 48 hours)
- Paresthesia (disturbance of sensitivity)
If the edema is prolonged, it is possible to massage the area to accelerate the evacuation of the gas.

The chronic wounds treatment injections can be made with a 13 mm needle because of the need to reach
the hypodermis to improve the vascularization. To reduce the risk of injury, injections must always be made
with the skin stabilizer on the device and the needle at 45° to the skin surface.

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It is important to monitor the face of the patient during injections, to see its reactions and if injections are
well supported. If the patient has a pain rictus, the doctor must revisit his gesture. It is necessary to
proceed in this way: the skin is penetrated with the needle, the reaction of the patient is immediately
observed and if there is no pain, keep the trigger button pressed in order to inject. If pain occurs, the
trigger must be released to allow the needle to retract or gently remove the needle if the manual mode is
activated and then move the needle to inject a few millimeters away. Otherwise, the injection may be
painful and be followed by a hyperalgesic period.

Hemostasis at the end of a session should last several minutes to prevent bruising from occurring with
delay, after the session. This haemostasis can be achieved by local hand compression or by the patient's
own weight. Finally, a non-allergenic compress maintained by a plaster may be proposed if it is left in place
for a few minutes (do not forget to warn the patient to remove it within this time).

It is necessary to avoid any treatment of an area which has just been treated with carboxytherapy until
complete healing of the puncture points.

To limit possible blood pressure decreases or neurovegetative reactions (sweating, pallor, small passing
discomfort), the patient must always be in a sitting or lying position during treatment. In addition, if the
patient feels discomfort during treatment, the treatment must be discontinued.

1.4 WARNINGS AND SAFETY NOTICES

WARNING: Use of Concerto is strictly reserved to the physicians who can justify a
specific formation to practice mesotherapy and carboxytherapy. All the users must
know risks, side effects and contraindications due to its application and those related
to injected products. For information about available trainings, call +33(0)4 66 32 44
99.

WARNING: If a malfunction, a potential danger or a performance change are

observed during the use of the device, treatment should be immediately
discontinued and the after sales department contacted.

WARNING: User must wear gloves for any handling of the device and its accessories.

WARNING: Mesotherapy and carboxytherapy should not be performed without

informing patients about its progress and implications and without their consent.

WARNING: The device must be used only with the components provided and with CE
mark under the responsibility of the physician who accomplishes the act. Injected
products must be sterile drugs or medical devices and be injected according to their
marketing authorization or medical CE. All the components used with the device
must be sterile and single use. The device is also intended to inject sterile medical
CO2.

WARNING: Liquid must not be spilled on the device.

WARNING: Always hold the device with the needle facing down to avoid spillage of
product on or in the device.

WARNING: The device must be used only with the power supply cord or the battery
charger provided.
If you have any doubt about your supply, ask to a qualified electrician to inspect your
electrical installation.

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WARNING: To avoid the risk of electric shock, this equipment must be connected
only to a supply mains with protective earth.

WARNING: Never use the device with wet hands.

WARNING: To avoid any risk of serious injury or electric shock:

-Do not use the power supply cord or the battery charger if they are damaged.
-Do not use the device or the components in your bath or with your foot in the
water.
-Do not use the device or the battery charger if they are wet by any liquid.
-Never try to disassemble the device or the battery charger to avoid to be exposed to
dangerous voltage or any other risk.
-Do not try to force the power supply cord plug or the battery charger plug to avoid
to be exposed to dangerous voltage or any other risk.

WARNING: Make sure the connections are fully inserted before using the device.
Never disconnect a connector while the power is ON.

WARNING: The short tube, the long tube, the needle, the syringe and the
bacteriological filter are sterile and single use components. They must be changed
between each patients. The skin stabilizer must be disinfected before each use (refer
to 4.1). The Concerto components which are provided sterile require wearing gloves
to be handled during and after opening. If the packaging ensuring sterility of a single
use component is damaged, the component must be eliminated without use.

WARNING: Before each treatment, disinfect the treatment area with an antiseptic
solution.

WARNING: Any Concerto use on delicate areas (eye orbit, oral area…) is forbidden.
WARNING: In normal use, take care that the patient never touches the syringe
pressure sensor.

WARNING: In normal use, do not touch the following elements more than 10
seconds otherwise warm: power supply, the part on the motors (under syringe) and
the screen.

The non-respect of these warnings and safety notices relieves the manufacturer of any responsibilities in
case of problem.

1.5 IDENTIFICATION AND MANUFACTURER

Identification

Device range MESOTHERAPY and CARBOXYTHERAPY

Class IIa
CE marking year: 2011
Model: CONCERTO
Serial number: CO amm-0000

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Manufacturer

BFP Electronique
Pôle Technologique de Vimenet
48100 MONTRODAT – France
 : +33 (0)4 66 32 44 99
 : +33 (0)4 66 32 45 03
E-mail: bfp.electronique@wanadoo.fr

1.6 LABELS AND SYMBOLS

Label(s)

Device

Battery charger

Symbols Meaning
Manufacturer

Consult instructions for use

CE mark

Caution

Serial number

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 Not to be used in case package is damaged

Waste electrical and electronic equipment

Type B applied part

Class II equipment
Direct current
Polarity: the center (point) of the output plug is positive (+) and the body of the
output plug is negative (-)

Home use

Chinese RoHS: period during which toxic substances are enclosed in components

Electrical safety approved by Demko

UL compliance United States and Canada

Performance level
Japanese compliance for EMC

2 DEVICE

2.1 COMPONENTS AND DEVICE

Components

Make sure the suitcase you received with your device contains:
- A suitcase
- Concerto device
- A battery charger
- A gas regulator
- 6 skin stabilizers
- 2 short tubes
- 2 long tubes
- A bacteriological filter

If any of these items is missing when opening, we apologize in advance. Please contact immediately our
After Sales Department: phone +33(0)4 66 32 44 99 or mail sav.bfp@orange.fr

WARNING: If the packaging of one of this component is damaged, DO NOT USE this
component or the device.

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Device description

Closed cover view

Cover Control
panel

Syringe pressure
sensor

Needle
support
Battery
plug

Skin
stabilizer
and LED

Trigger button

Open cover view

Carboxy
kit

Syringe
cursor
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Control panel view

Control
screen

Touchpad
Validation
touch button

Applied parts

The applied parts are the needle and the skin stabilizer.

2.2 PHYSICAL CHARACTERISTICS

Length: 29 cm
Dimensions Width: 16 cm
Height: 6 cm
Weight 420 g
Safe working load 0 kg
Voltage 18 V direct
Power 900 mA
Screen OLED 128x128
Type: Li-ion
Capacity: 900 mA/hour
Charging voltage: 18 V
Battery
Autonomy: 8 hours
Time to full charge: 2 hours
Lifetime: 500 cycles

2.3 PERFORMANCES

Essential performance

The Concerto has not essential performance.

Settings Settings range Accuracy

Injected dose volume See according to the program +/- 3%
Depth See according to the program +/- 0.5 mm

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 2.4 INSTALLATION

Assembly

WARNING: Opening, handling and assembly of Concerto components require to

wear gloves. If the packaging ensuring sterility of a single use component is damaged,
the component must be eliminated without use.

1. Needle/short tube/syringe set (mesotherapy mode)

The Concerto can work with different standard type of needle and syringe (1, 2, 5 or 10 ml). In some
modes, the syringe volume and the type of needle used must be set to ensure the good volume.

WARNING: To avoid any spillage of product on or in the device, realize all

connections between the needle, the tube and the syringe before to place them on
the device.

Start by filling the syringe with the product to be administered and check there are no air bubbles. To
assemble the set needle/short tube/syringe, connect them as the following photo.

Syringe

Needle

Short
tube

Then place the syringe on the device, the syringe extremity must be placed against the syringe pressure
sensor as the following photo.

WARNING: Do not apply pressure with the syringe on the pressure sensor.

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 Syringe
pressure
sensor

Then place the needle in the needle support as the following photo.

Wrong Right
assembly way assembly way

WARNING: When the complete set is in place, purge the air in the syringe and the
tube by pressing the trigger button in continuous mode and with the needle facing
down to avoid spillage of product on or in the device.

2. Long tube/short tube/needle set (carboxytherapy mode)

Connect the long tube extremity to the bacteriological filter and to the regulator and then to the CO2
bottle. Connect the other extremity to the short tube itself connected to the needle. Then place the short
tube in the slot against the pressure sensor.

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 Wrong
assembly

Tube
extremity too The tube is
away from not placed on
the device this side

Right
assembly

The tube is
correctly placed The tube
on the 2 sides extremity
is close to
the device

3. Skin stabilizer

The skin stabilizer allows to control the depth injection according to the needle move. It is also a micro-
massage vector by vibration when it is activated.

WARNING: Before assembly and use of the skin stabilizer, the skin stabilizer must be
disinfected with a medical device solution of 2% glutaraldehyde before each use
(refer to the manufacturer instructions of the disinfecting solution to know how to
use it). Do not use another disinfection method.

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WARNING: The device can be used without the skin stabilizer. In this case, the depth
management must be ensured by the user himself and under its sole responsibility.

Use the hemispherical skin stabilizer for injections programmed in MESO or EXPERT.

Use the angular skin stabilizer for injections programmed in FILLER.

The skin stabilizer is inserted in the skin stabilizer support at the device extremity. To remove it, make the
reverse operation.

Skin
stabilizer
support

WARNING: When the device is connected to the battery charger, the battery charger
must always be positioned in order to the plugs are easily accessible to be
disconnected.

3 INSTRUCTIONS FOR USE

3.1 START-UP

To start-up the device, press the trigger button one time. The control screen of the control panel turns on
and display the settings of the last program used before the device was turned off.

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 3.2 DOING A TREATMENT

WARNING: Before each treatment, disinfect the treatment area with an antiseptic
solution.

WARNING: Before assembly and use of the skin stabilizer, the skin stabilizer must be
disinfected with a medical device solution of 2% glutaraldehyde before each use
(refer to the manufacturer instructions of the disinfecting solution to know how to
use it). Do not use another disinfection method.

WARNING: Before each treatment, clean the device with a 70% isopropyl alcohol
wipe. Wait until alcohol has evaporated before starting treatment. Also clean the
device with 70% isopropyl alcohol wipe at the end of treatment.

WARNING: Always hold the device with the needle facing down to avoid spillage of
product on or in the device.

Carboxytherapy treatment of chronic wounds of tibia and foot with local hypoxia (involving diseases of
the arterial trunks, chronic venous insufficiency, and alterations of glucose metabolism)
Use a skin stabilizer.
Do 2 treatments per week spaced 2 to 3 days for 6 weeks.
Use a 30G needle of 13 mm.
Subcutaneous injection, depth of 10 mm, angle of 45° to the surface of the skin.
Injections in the vascular axes (femoral triangle, middle third of thigh, adductor canal, Boyd perforator,
popliteal fossa and middle third of leg): injection of 50 cc for each area, the injections are spaced 2 cm
apart (inject 5 to 10 cc per site). Treatment must be bilateral.

In the area surrounding the wound: inject into healthy areas at least 2 cm from the injured skin, 5 cc per
site.

Menu navigation

To navigate in the menus, use the validation touch button and the touchpad.

The main menu presents the MESO, CARBOX and OPTION menus. On the following photo, the selected
MESO menu is highlighted. To select another menu, use the touchpad.

MESO allows to accede to the MESO, EXPERT and FILLER programs.

CARBOX allows to accede to the carboxytherapy program.
OPTION allows to accede to the device settings.

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To validate the selection, press briefly the validation touch button. To return to the previous menu, do a
long pressure on the validation touch button.

Switching from carboxytherapy mode to mesotherapy mode

Select MESO in the main menu and validate with the validation touch button, the next screen displays:

Press Syringe
the cursor
trigger withdraw
button

A pressure on the trigger button initiates the retreat of the syringe cursor and detached automatically the
cover to allow its removal. Next, remove the carboxy kit and press the trigger button to validate. Then the
device is ready to be used with the MESO, EXPERT and FILLER modes.

Switching from mesotherapy mode to carboxytherapy mode

Select CARBOX in the main menu and validate with the validation touch button, the next screen displays:

Syringe cursor
withdraw

The syringe cursor automatically backs and a screen asks to install the carboxy kit. Place the carboxy kit on
the syringe cursor in the notches and validate with a pressure on the trigger button. The carboxy kit comes
in contact with the pressure sensor and backs to allow the tube installation. Place the cover by positioning
the 2 notches in the front of the device and press the cover on the device until it clicks. Then the device is
ready to be used with the carboxytherapy mode.

Put the syringe in pressure (mesotherapy mode)

To put the syringe in pressure, make sure an injection program is activated (MESO, EXPERT or FILLER) on
the screen. When the needle/short tube/syringe set is placed on the device, press briefly the trigger button.
The syringe cursor moves automatically in the direction of the syringe plunger until it comes in contact.
Once in contact, the syringe is maintained between the syringe cursor and the pressure sensor.

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 Syringe cursor Syringe plunger

Once in contact, the syringe is maintained between the syringe cursor and the pressure sensor and the
following indicator is displayed on the screen:

MESO program (mesotherapy mode)

This program allows to make nappage injections. Use the hemispherical skin stabilizer.

SPEED/DEPTH

Depth in mm
Speed

The programmable settings are:

- Depth injection DEPTH: 1 to 4 mm for a 4 mm needle; from 1 to 6 mm for a 6 mm needle; from 1 to
10 mm for a 13 mm needle
- Speed injection SPEED: continuous injection or burst injections from 1 to 5

To switch between the settings, press briefly the validation touch button. To modify a selected setting, use
the touchpad. A color code indicates the selected setting: DEPTH (white) and SPEED (blue).

To do a treatment, press the trigger button by placing the device at an angle of 45° to the surface of the
skin and moving the apparatus in the opposite direction to the direction of the tip 'needle.

WARNING: To reduce the risk of scratches of the skin, the device limits automatically
the nappage speed according to the depth injection (refer to the following table).

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The injected dose volume accuracy is +/- 3%.

Dose table for MESO program

Depth 1 ml syringe 2 ml syringe 5 ml syringe 10 ml syringe

Continuous 1 to 10 mm
Speed 1 1 to 10 mm 1/780 ml 1/210 ml 1/120 ml 1/83 ml
Speed 2 1 to 10 mm 1/1110 ml 1/300 ml 1/170 ml 1/120 ml
Speed 3 1 to 8 mm 1/1560 ml 1/425 ml 1/240 ml 1/167 ml
Speed 4 1 to 6 mm 1/1950 ml 1/530 ml 1/300 ml 1/209 ml
Speed 5 1 to 2 mm 1/3900 ml 1/1060 ml 1/600 ml 1/418 ml

EXPERT program (mesotherapy mode)

This program allows to make point by point injections. Use the hemispherical skin stabilizer.

SYRINGE/DEPTH/DOSE

1/2/5/10 ml syringe

Depth in mm

Dose
in ml
The programmable settings are:
- Volume of the syringe used SYRINGE: 1, 2, 5 or 10 ml
- Depth injection DEPTH: from 1 to 4 mm for a 4 mm needle; from 1 to 6 mm for a 6 mm needle;
from 1 to 10 mm for a 13 mm needle
- Injected dose DOSE: continuous injection or 0.01 mL, 0.02 mL, 0.03 mL, 0.04 mL, 0.05 mL, 0.08 mL,
0.010 mL, 0.12 mL, 0.15 mL, 0.18 mL, 0.20 mL, 0.30 mL, 0.40 mL, 0.50 mL

To switch between the settings, press briefly the validation touch button. To modify a selected setting, use
the touchpad. A color code indicates the selected setting: SYRINGE (purple), DEPTH (white) and DOSE
(yellow).

To do a treatment, press the trigger button by placing the device to inject perpendicularly to the treatment
area. Maintain the trigger button pressed during all the time necessary to the injection. The needle backs
automatically from the injection point when the programmed dose is totally administered.
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FILLER program (mesotherapy mode)

This program allows to make withdrawal injections. Use the angular skin stabilizer.

SYRINGE/RETRO/DOSE

1/2/5/10 ml syringe

Withdrawal
speed of the
needle

Dose

The programmable settings are:

- Volume of the syringe used SYRINGE: 1, 2, 5 or 10 ml
- Withdrawal speed of the needle RETRO: NO (no automatic withdrawal), LOW (slow withdrawal),
MEDIUM (medium speed withdrawal) and FAST (fast withdrawal)
- Injected dose DOSE: LOW (low dose), MEDIUM (medium dose) and HIGH (high dose)

To switch between the settings, press briefly the validation touch button. To modify a selected setting, use
the touchpad. A color code indicates the selected setting: SYRINGE (purple), RETRO (white) and DOSE
(yellow).

To do a treatment, hold the device far away from the patient and maintain pressed the trigger button
during 3 seconds (you hear 3 bips), the needle will automatically goes forward. Then insert the needle
manually in the treatment area, and after maintain pressed the trigger button while ensuring a perfect
device stability until the end of the injection.

WARNING: If the setting NO is selected, the needle goes forward automatically but
the withdrawal must be done manually by the operator.

CARBOX program (carboxytherapy mode)

This program allows to make carboxytherapy treatment. When the program is selected, and the carboxy kit
installed, a trigger button pressure displays the next screen:

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Place the tube on the device by observing well the assembly diagram (refer to the long tube/short
tube/needle set assembly). Then press the trigger button to go forward the syringe cursor and the carboxy
kit which goes to pinch the tube against the pressure sensor. The following indicator is displayed on the
screen

NEEDLE/MODE/
DEPTH/DOSE

Type of Depth
needle used in mm

Dose
in cc

The programmable settings are:

- Type of needle used NEEDLE: 25G, 27G, 30G or 32G
- Injection mode MODE: automatic (AUTO) or manual (MANU)
- Depth injection DEPTH: from 1 to 4 mm for a 4 mm needle, from 1 to 6 mm for a 6 mm needle,
from 1 to 10 mm for a 13 mm needle
- Injected dose DOSE: in manual (MANU) for continuous injection or 10 cc, 15 cc, 20 cc, 25 cc, 50 cc,
75 cc, 100 cc.

To switch between the settings, press briefly the validation touch button. To modify a selected setting, use
the touchpad. A color code indicates the selected setting: NEEDLE (purple), MODE (blue), DEPTH (white)
and DOSE (yellow).

The automatic mode AUTO allows to the needle to go forward at the selected depth. To inject the total
selected dose, maintain press the trigger button. The needle withdrawal is automatically done at the end of
the injection. This injection mode is similar to the point by point injections in mesotherapy. The injection
can be stopped at any moment by stopping the pressure on the trigger button.

The manual mode MANU allows to make injections on thin or sensitive areas. First, hold the device far
away from the patient and maintain pressed the trigger button during 3 seconds (you hear 3 bips), the
needle will automatically go forward at the selected depth. Release the trigger button. Then insert the
needle manually in the treatment area, and after maintain pressed the trigger button while ensuring a
perfect device stability until the end of the injection. The injection can be stopped at any moment by
stopping the pressure on the trigger button.

If the DOSE is set on MAN, the injection is continuous and the volume injected is displayed on the screen. If
an accurate dose is selected, the injection is made during as long as the trigger button is maintained
pressed and stops when the set dose is administered. A vibration indicates progressively the number of cc
administered.
If the needle is set on 30G or 32G, each vibration represents 1 cc injected.
If the needle is set on 25G or 27G, each vibration represents 5 cc injected.

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Syringe removal (mesotherapy mode)

At the end of the treatment, to remove the syringe, ensure an injection program MESO, EXPERT or FILLER is
activated on the screen and press the touchpad during 3 seconds. The syringe cursor backs until the end of
the pressure and allows the syringe removal.

Tube removal (carboxytherapy mode)

At the end of the treatment, to remove the tube, close the gas supply and press the touchpad during 3
seconds. The next screen is displayed:

Press the trigger button, the cursor syringe backs and allows the tube removal.

Indicators displayed on the screen

Voyants Meaning
Indicates the syringe is maintained (between the
syringe cursor and the pressure sensor)
Indicates a too high pressure on the needle
Indicates the tube is maintained (between the kit
carboxy and the pressure sensor)

Indicates the battery charge level

Indicates the device is in charge

3.3 SHUTDOWN PROCEDURE

The device automatically shuts down after 4 minutes.

3.4 CONFIGURATION

From the main menu, the OPTION menu allows to configure the device through 2 submenus NEEDLE and
SERVE.

NEEDLE

In the NEEDLE submenu, the programmable settings are:

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 - NEEDLE: the needle length used 4, 6 or 13 mm
- OFFSET: that adjustment allows to calibrate the unit according to the length's difference between
the various marks of needles

To switch between the settings, press briefly the validation touch button. To modify a selected setting, use
the touchpad.

To calibrate, set up a needle and a skin stabilizer on the unit, validate the needle's current length (4, 6 or 13
mm), then select an OFFSET value (0, 1 or 2) until the needle stands 1 mm out of the skin stabilizer as
indicated on the below picture.

The needle stands 1

mm out of the skin
stabilizer

The OFFSET calibration will make sure that the depth programmed during the treatment will be exact.

SERV

In the SERV submenu, the programmable settings are:

- LED: LED lightning next to the skin stabilizer can be activated ON or deactivated OFF during a
treatment
- VIB: the micro massage by vibration can be activated ON or deactivated OFF during a treatment
- CONTRAST: adjust the contrast of the control screen from 20 to 100%

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To switch between the settings, press briefly the validation touch button. To modify a selected setting, use
the touchpad.

3.5 BATTERY (IF APPLICABLE)

Battery charging

The Concerto device is equipped with an internal Lithium/Ion battery.

The next indicator indicates permanently the battery charge level:
When the indicator indicates that the battery level is low (orange color), connect the battery connector to
the device with the battery charger provided.
During the battery charge, the next indicator is displayed:

Concerto use is possible when it is in charged.

WARNING: To charge the battery, always lay down the device on a horizontal area
because the weight of the cord can cause the device fall and damage.

WARNING: Use the device only with the battery charger provided.

WARNING: The device must always be positioned in order to the plugs are easily
accessible to be disconnected.

4 CLEANING AND MAINTENANCE

4.1 CLEANING AND/OR DISINFECTION

Device cleaning

WARNING: To be cleaned, the device plug must be disconnected. Liquid must not be
spilled on the device. Do not soak the equipment in a liquid.

The device must be cleaned with a 70% isopropyl alcohol wipe (do not use another product).

Disinfection
The short tube, the long tube, the needle, the syringe and the bacteriological filter are sterile and single use
components. The skin stabilizer must be disinfected with a medical device solution of 2% glutaraldehyde
before each use (refer to the manufacturer instructions of the disinfecting solution to know how to use it).

WARNING: Do not use another skin stabilizer disinfection method.

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WARNING: Before each treatment, disinfect the treatment area with an antiseptic
solution.

4.2 MAINTENANCE, SERVICE, TRANSPORT AND WARRANTY CONDITIONS

Maintenance and service

WARNING: The device must not be in maintenance or service during its use.

WARNING: No modification of this equipment is allowed.

WARNING: Lithium battery must be replaced only by a qualified staff in factory.

The lifetime of the device is 5 years. An annual factory revision is highly recommended.

For the lifetime and the maintenance conditions of the gas regulator, refer to the corresponding
instructions for use and datasheet.

It is recommended to regularly inspect all the electrical connections.

Transport

The device can be stored or transported in its original packaging.

Warranty conditions

The device is warranted against defects in material and manufacturing for 2 years from the date of invoice,
except if the device has been misused or poorly maintained not in accordance to this notice.
This warranty is applicable only for the original purchaser and only if purchased from an authorized dealer.
If the product presents a defect during the warranty period contact the After Sales Department: phone
+33(0)4 66 32 44 99 or mail sav.bfp@orange.fr

This warranty does not cover damaged product such as:

- Accident, misuse, negligence or modification
- Repairs carried out by unauthorized persons
- Connection to an incorrect voltage or supply
- The uses and maintenance not in accordance with this notice
- Damage due to operator error, negligence or wrong connection (made with the original
components or other components) in an abusive or abnormal use, an intentional or accidental
physical modification
- Detachable parts or components whose replacement results from their normal wear or routine
maintenance
- Transport and device modification costs, in case of a recall by the manufacturer for a defect
- Damages due to external events (lightning, water damage…)
- Interventions on the device by any person not authorized by the After Sales Department as well as
malfunctions and consequential damage to intervention
- Any other condition out of our control
In case of problems or if you have questions about the use of this equipment, you can contact us as follows:

Contact :
BFP Electronique
Pôle Technologique de Vimenet
48100 MONTRODAT
CONCERTO - Rev. 08 – EN- 07/03/2018 Page 28/34
 France

E-mail : bfp.electronique@wanadoo.fr
Phone: +33(0)4 66 32 44 99
Fax: +33(0)4 66 32 45 03

4.3 POSSIBLE PROBLEMS

Problems Troubleshooting steps

Maintain a pressure on the touchpad during 3
The needle is moving, but the cursor is not in
seconds to back the cursor syringe, then press the
contact with the syringe plunger. The syringe is not
trigger button once to put the syringe plunger in
correctly detected by the pressure sensor.
contact with the cursor.
Systematic and continuous detection of the syringe. Do a back slight manual pressure on the stainless
The pressure sensor is in permanent contact. steel plate of the pressure sensor.
Connect the battery charger to the device and start
The device does not start up. The battery is empty.
up it.
A red indicator is displayed, and a sound signal
Press the trigger button to re-engage the needle.
activates. The needle is blocked in forward position.
Connect the battery charger to the turned on
device and disconnect it to do a reset. A vibration
The system is blocked.
occurs then the screen becomes black and turned
on again.

If the problem persists, contact the After Sales Department: phone +33(0)4 66 32 44 99 or mail
sav.bfp@orange.fr

4.4 DISPOSAL OF HAZARDOUS MATERIAL

WARNING: Device components are subject to strict environmental regulations. They

must be disposed of according to current regulations in each country and each
institution.

WARNING: When the device is at the end of life, return it to the manufacturer for
destruction.

5 TECHNICAL DESCRIPTION

5.1 ENVIRONMENTAL CONDITIONS

Transport Storage Use

Temperature -20°C to 60°C -20°C to 60°C 15°C to 35°C
Humidity 20-75% (without condensation)
Atmospheric pressure 79.4 kPa to 101.3 kPa
The device can be stored or transported in its original packaging.

WARNING: The device must be used and stored in a ventilated area.

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 5.2 ELECTROMAGNETIC COMPATIBILITY

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The Concerto needs specific cares regarding the electromagnetic compatibility (EMC) and must be used and
set up according to the information here mentioned.

Any cordless unit dedicated to transmission type radio frequency can affect the Concerto.
The use of accessories, sensors and cables different than the ones indicated by the manufacturer can
induce higher emissions or reduce the immunity of the Concerto.
The Concerto must not be used beside, under or on any other equipment. In the case of a necessary
adjacent or piled up use, the right function of the Concerto must be controlled and verified in the new
configuration.

Guidance and statements of the manufacturer — electromagnetic emission

The Concerto is dedicated to be used in the electromagnetic environment specified below.
The user must be sure that it is used in a such environment.
Environment electromagnetic —
Emission tests Compliance
guidance
The Concerto uses RF energy only
in its internal functions.
RF emissions CISPR 11 Group 1 Consequently, its RF emissions
are very low and can’t cause any
interference on a nearby unit.
RF emissions CISPR 11 Class B
The Concerto can be used
Harmonic emissions IEC 61000-3-
Class A anywhere, included in the
2
domestic places and the ones
Voltage fluctuations / flicker
connected directly to the public
emissions Compliant
main power supply low voltage.
IEC 61000-3-3

Guidance and statements of the manufacturer — electromagnetic immunity

The Concerto is dedicated to be used in the electromagnetic environment specified below.
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 The user must be sure that it is used in a such environment.
Electromagnetic
Test level
Immunity Test Compliance level environment —
IEC 60601
guidance
Floors must be made of
wood, concrete or
Electrostatic discharge ± 6 kV in contact ± 6 kV in contact ceramic tile. If floors are
(ESD) recovered with synthetic
IEC 61000-4-2 ± 8 kV on air ± 8 kV on air materials, the relative
humidity must be at
least 30%.
The quality of the power
Electrical fast ± 2 kV for power supply supply network should
± 2 kV for power supply
transient/burst lines be equal to a typical
lines
IEC 61000-4-4 ± 1 kV for IN/OUT lines commercial or hospital
environment.
The quality of the power
± 1 kV between phases Non applicable supply network should
Transitional over voltage
± 2 kV between phase Device powered by be equal to a typical
IEC 61000-4-5
and ground battery commercial or hospital
environment.
The quality of the power
< 5% UT
0% for 0.5 cycles supply network should
(>95 % dip in UT) for 0,5
be equal to a typical
cycle
Voltage dips, short commercial or hospital
40 % UT
interruptions and 40% for 5 cycles environment.
(60 % dip in UT) for 5
voltage variations on If the Concerto must be
cycles
power supply input used continuously
70 % UT
lines. 70% for 25 cycles during power cut, it
(30 % dip in UT) for 25
IEC 61000-4-11 should be powered on
cycles
through a permanent
<5 % UT
0% for 5 seconds power supply or a
(>95 % dip in UT) for 5 s
battery.
The quality of the
magnetic fields at the
Power frequency (50/60
electric network
Hz)
3 A/m Compliant frequency must have
magnetic field
the characteristic levels
IEC 61000-4-8
of a typical commercial
or hospital environment.
NOTE : UT is the alternating current mains voltage prior to the application of the test level

Guidance and Statements of the Manufacturer — Electromagnetic Immunity

The Concerto is dedicated to be used in the electromagnetic environment specified below.

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 The user must should be sure that it is used in a such environment.
Test level Compliance Electromagnetic environment —
Immunity Test
IEC 60601 level guidance
The portable and mobile devices of Radio Frequency
communications must not be used nearest of the
Concerto, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
Perturbations
3 Veff d=1.16√P
RF conducted 3V
150 kHz to 80 d =1.16√P 80 MHz to 800 MHz
IEC 61000-4-6
MHz d = 2.33√P 800 MHz to 2,5 GHz
where P is the maximum output power rating of the
transmitter in watts (W), according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Perturbations RF
3 V/m Field strengths from fixed RF transmitters, as
radiated 3 V/m
80 MHz to 2,5 GHz determined by an electromagnetic site survey,
IEC 61000-4-3
should be less than the compliance level in each
frequency range.
Interferences may occur in the vicinity of equipment
marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 Theses guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the Concerto is used exceeds the applicable RF compliance level above, the Concerto should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting OR relocating the Concerto.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and
the Concerto

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 The Concerto is intended for use in an electromagnetic environment in which radiated RF perturbations
are controlled. The user of the Concerto can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the
Concerto as recommended below, according to the maximum output power of the communications
equipment.
Separation distance in meters (m) according to frequency of transmitter
Rated maximum output 80 MHz to 800
150 kHz to 80 MHz 800 MHz to 2,5 GHz
power (W) of transmitter MHz
d = 1,2√P d = 2,3√P
d = 1,2√P
0,01 0.12 0.12 0.23
0,1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

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