PAGE INTENTIONALLY LEFT BLANK

2
PRESENTATION OF THIS MANUAL
Technical Name: Delivery Units and Accessories
Trade Name: Delivery Units
Models: Syncrus G2
Brand: Dabi Atlante

Technical Manager: Daniel R. de Camargo

CREA-SP: 5062199650

ANVISA Registration No.: 10069210075

Alliage S/A Industrias Médico Odontológica

Rodovia Abrão Assed, Km 53 + 450m - CEP 14097-500
Ribeirão Preto - SP - Brazil
Phone: +55 (16) 3512-1212

CINTERQUAL – Soluções de Comércio

Internacional, Lda.
Avenida Defensores de Chaves, Nº 4
Escritório Idea Spaces
1000-117 Lisboa, Portugal

77000000964 - Rev.: 04 - March/22

Document originally written in Portuguese.

3
TRADEMARKS
All terms mentioned in this manual that are known trademarks, registered trademarks or service
marks have been appropriately labeled as such. Other products, services or terms that are mentioned
in this manual may be trademarks, registered trademarks or service marks of their respective owners.
Alliage S/A makes no claims regarding these trademarks. The use of a term in this manual should
not be considered to influence the validity of any trademark, registered trademark or service mark.

Copyright © 2019 Alliage S/A. All rights reserved.

The performance characteristics provided in this manual are for reference only and should not be
considered as guaranteed specifications.

4
TABLE OF CONTENTS
01 GENERAL INFORMATION 08
1.1. DEAR CUSTOMER 08
1.2. INDICATIONS FOR USE 08
1.3. CONTRAINDICATION 08
1.4. SYMBOLOGY 08

02 WARNINGS, CAUTIONS AND RECOMMENDATIONS 14

03 SYSTEM GENERAL DESCRIPTION 19

3.1. SYSTEM DESCRIPTION 19
3.2. APPLICATION SPECIFICATION 19
3.2.1. Operating principles 19
3.2.2. Significant physical characteristics 19
3.2.3. User Profile 19
3.3. PRODUCT MAIN COMPONENTS 20
3.3.1. Equipo 20
3.3.2. Accessories 21
3.4. PARTS APPLIED 24
3.5. LABELS POSITIONING 24
3.6. SYSTEM REQUIREMENTS 25
3.6.1. Compressor requirements 25
3.6.2. Vacuum pump requirements 25
3.6.3. Installation location 27
3.6.4. System layout 27

04 OPERATION 29
4.1. INITIAL PREPARATION 29
4.2. ELECTRIC MICROMOTOR ACTIVATION 38

05 CLEANING, DISINFECTION AND STERILIZATION 40

06 PROBLEMS DIAGNOSTICS 42
6.1. TROUBLESHOOTING 42

07 INSPECTION AND MAINTENANCE 45

7.1. PERIODIC INSPECTION 45
7.2. PREVENTIVE MAINTENANCE 45
7.3. CORRECTIVE MAINTENANCE 46
7.4. ALLIAGE AUTHORIZED SERVICE NETWORK 47

08 WARRANTY 49

09 STANDARDS AND REGULATIONS 51

10 TECHNICAL SPECIFICATIONS 53
10.1. EQUIPMENT CLASSIFICATION 53
10.2. DEVICE INFORMATION 53
10.3. SPECIFIC INFORMATION 54
10.4. LED CURING LIGHT SPECIFICATION 54
10.5. ULTRASOUND SPECIFICATIONS 55
10.6. ENVIRONMENTAL CONDITIONS 55

5
TABLE OF CONTENTS
10.7. EQUIPMENT DIMENSIONS 56

11. ELECTROMAGNETIC COMPATIBILITY 58

11.1. ORIENTATION AND DECLARATION FOR ELECTROMAGNETIC EMISSIONS 58
11.2. ORIENTATION AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY 59

6
 1
GENERAL INFORMATION

Alliage S/A Industrias Médico Odontológica

Phone: +55 (16) 3512-1212
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 – Ribeirão Preto – SP – Brazil

7
1. GENERAL INFORMATION
1.1.DEAR CUSTOMER
Congratulations on your excellent choice. By purchasing equipment with ALLIAGE quality, you can
be assured of acquiring products with a technology compatible with the best in the world in its
class. This manual provides you with a general presentation of your equipment, describing important
details that may guide you in your correct use, as well as in solving small problems that may occur.
This manual should be read in full and kept for future reference.

1.2.INDICATIONS FOR USE

The Delivery Unit are intended to assist in the treatment and removal of caries, removal of
restorations and odontosection, as an aid in the extraction of teeth, also indicated for burning
mouth syndrome, dental abscesses, dental abrasion, among others linked to dental treatment.

1.3.CONTRAINDICATION
There is no known contraindication for this equipment.

1.4.SYMBOLOGY
The following symbols are used both throughout this manual and in the product. Make sure that
you fully understand each symbol and follow the accompanying instructions.

Fragile, handle with care Maximum stacking

Protect from rain Temperature limit

This side up Do not step

Keep away from sunlight Recyclable

8
 Sterilizable in a steam sterilizer
Movable Parts (autoclave) at specified
temperature

It indicates that the product

should be taken to a special
Parts applied type B garbage collection location at the
end of its useful life. It applies to
both the device and accessories

Electrostatic Sensitive Devices

Attention
(ESD)

Protective ground Action required

Follow the instructions for use General warning

Warning;
High voltage Do not reuse

Forward tilt Bio-system activation

9
It descends the seat It ascents the seat

It ascents the backrest It descends the backrest

Back to zero Determines work positions 1

Determines work positions 2 Determines work positions 3

Determines work positions 4 Massage zone

Arm fall Ultrasound

Reflector activation Bicarbonate jet

10
Inversion of the electric micromotor Ejector with controllable valve
rotation direction (Vac-plus)

Water activation in cup holder Dental Turbine

Optical fiber Motion stop

Syringe Electric Motor

Negatoscope lamp Spray cooling

Saliva suction controllable valve

Water activation in the bowl
(Venturi)

Program 1 Program 2

11
Program 3 Plus key and Minus key

Authorized Representative in the

Forward/backward key
European Community

It indicates that equipment

complies with Directives 2011/65/
EU and 2015/863/EU on the
Model
Restriction on the use of certain
hazardous substances in electrical
and electronic equipment.

Manufacture Date Catalog number

Model number Serial number

Manufacturer

12
 2
WARNINGS, CAUTIONS AND RECOMMENDATIONS

Alliage S/A Industrias Médico Odontológica

Phone: +55 (16) 3512-1212
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 – Ribeirão Preto – SP – Brazil

13
2. WARNINGS, CAUTIONS AND RECOMMENDATIONS
General warnings

Please read and understand all instructions contained in these instructions

for use before installing or operating this equipment.

Use only the equipment in perfect condition and protect yourself, patients
and third parties from any hazards.

This equipment must be installed and operated by personnel familiar with the
necessary precautions.

The Delivery Unit has 4 different interactions with the user, being:
- Identification label: Located on the side of the equipment;
- Safety symbologies: Located at the dangerous places and on their
identification label;
Central panel;
- Side panel;

During transportation
The equipment must be transported and stored, observing the following:
• Handle care to avoid falls, excessive vibrations and impacts;
• The packing arrows should be pointing upwards;
• To handle the package as a single unit, consider the center of the gravity indicator;
• Do not stack above the quantity indicated on the package;
• Do not walk or stand on the package;
• Protect against sunlight, moisture, water and dust;
• Observe the temperature, pressure and relative humidity limits.

During the equipment installation

The installation instructions can be found in the service manual, accessible

only to authorized technicians.

The equipment must be installed only by the authorized technician.

This is a technical procedure that cannot be performed by the user.

14
• The equipment should only be installed by authorized technical assistants.
• The recommendations of the service manual should be followed as to the mandatory existence
of protection grounding.
• Install the equipment in a place where it will not be in contact with moisture, water, plants and
animals.
• Install the equipment in a location where it will not be damaged by pressure, temperature, humidity,
direct sunlight, dust, airs or corrosive products.
• This equipment is not designed for use in the presence of vapors from flammable anesthetic
mixtures or nitrous oxide.
• Place any other external devices at least 1.5 meters away from the equipment, so that the patient
cannot touch any other external device while he/she is being serviced.
• The recommendations in this manual for EMC should be followed. Communications equipment and
RF-generating sources can affect the operation of the equipment.
• The equipment may cause radio interference or interrupt the operation of nearby equipment,
and it is necessary to take mitigating measures, such as reorientation, relocation of equipment or
shielding the place.

Before using the equipment

To help ensure proper hygiene and protect against infectious diseases, prior to first use, the
equipment should be cleaned and disinfected following the instructions contained in this manual.

When using the equipment

• Under no circumstances can the patient operate the equipment.
• The patient should not touch other parts other than those specific to be attended.
• The equipment should be operated only by qualified health professionals.
• While operating the equipment, the operating personnel must:
- Read and understand the user manual.
- Be familiar with the structure and fundamental functions of this equipment.
- Be familiar with the emergency situation protocols of this equipment.
- Be able to recognize irregularities in the operation of the equipment and implement the appropriate
measures when necessary.
• The equipment is designed according to electromagnetic compatibility standards, but in very
extreme conditions, it may interfere with other equipment. Do not use this equipment in conjunction
with other devices that are very sensitive to interference or with devices that create high
electromagnetic disturbances.

15
• Do not place the patient on the equipment while starting the equipment, as the patient may
be injured if the equipment does not work properly. If there is an error that requires turning the
equipment off and on, remove the patient before turning it back on.
• In case of risk to the patient, press the emergency button immediately located on the side of
the equipment.
• If this product is exposed to water, moisture or foreign substances, turn it off immediately and
contact an Alliage Authorized Service Center.
• In case of damage or defect, do not use the equipment and contact an Alliage Authorized Service
Center.
• Do not use the equipment if any of its compartments or parts are damaged, loose, or removed.
Contact an Alliage Authorized Service Center and request repair or replacement of any damaged,
loose, or removed enclosures or parts of the equipment before using the equipment again.
• Do not touch the equipment or use it if it is being repaired or if the equipment cabinets have
been removed.
• Do not open or remove any of the cabinets from the equipment. No internal part can be user-
reparable.
• In case of fall or impact of moving parts causing the breakage of the same, be careful when
handling them, there may be severe parts.
• This equipment does not produce physiological effects that are not obvious to the operator.
• The operator cannot contact the patient when in contact with accessible connectors.
• The operator cannot use tools to open the equipment.

Prevention against cross-contamination

Appropriate cleaning and disinfection/sterilization measures should be taken

to avoid cross-contamination between patients, users and others.

• For each new patient, perform the procedures of cleaning, disinfection/sterilization and according
to the instructions contained in this manual.

After using/operating the equipment

• Turn off the equipment if not in use for a long time.
• All parties that have had contact with the patient should be cleaned and disinfected/sterilized
to each new patient to avoid transmission of infectious agents that may cause serious diseases.
• Clean and disinfect/sterilize as instructed in this manual.
• Do not unplug the cable or other connections without needing to.
• Do not modify any part of the equipment.

Precautions in case of change in the equipment operation

If the equipment has any abnormalities, check to see if the problem is related to an item listed in
the "Problems Diagnostics" topic in this user manual.
If the problem cannot be resolved, turn off the equipment, contact an Alliage Authorized Service
Center.
• The heater can only be changed by the authorized Alliage Service Provider.

16
 The manufacturer is NOT responsible for:
• The equipment is used for purposes other than those for which it was designed.
• Damage caused to the equipment, operator and/or patient as a result of
incorrect installation and maintenance procedures in disagreement with the
operating instructions accompanying the equipment.

Precautions for reducing environmental impact

Alliage S/A aims to achieve an environmental policy to promote the supply of environmentally
conscious medical and dental products that continuously minimize environmental impact and are
more environmentally friendly to the environment and human health.
To maintain a minimal impact on the environment, please note the recommendations below:
• After installation, forward the recyclable materials to the recycling process.
• During the life cycle of the equipment, turn it off when it is not in use.
• To prevent environmental contamination, the disposal of waste and consumables should follow
the normal procedure for biomedical waste.
Biomedical waste includes non-acute materials likely to cause disease or suspected of harboring
pathogenic organisms that must be stored in a yellow bag properly labelled with a symbol of
biological risk, stored in a puncture-resistant container, watertight, until collection and incineration.

The Equipment packaging consists of wood, cardboard, plastic and expanded

polyurethane (PU) which are 100% recyclable materials.

DIMENSIONS:
Main unit: 1155 x 1070 x 470mm /MASS: Approximately: 30 Kg

Precautions in case of equipment being unused

To avoid environmental contamination or misuse of the equipment, when it is unused, it must be
disposed of (according to current legislation) in an appropriate place, because the materials inside
it can contaminate the environment.
For the European Economic Area (EEA), this product is subject to Directive 2012/19/EU as well as
the corresponding national laws. This policy requires that the product should be taken to a special
garbage collection location at the end of its useful life. It applies to both the device and accessories.
Contact the dealer if the final disposal of the product is required.

This equipment should not be disposed of as household waste.

17
 3
SYSTEM GENERAL DESCRIPTION

Alliage S/A Industrias Médico Odontológica

Phone: +55 (16) 3512-1212
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 – Ribeirão Preto – SP – Brazil

18
3. SYSTEM GENERAL DESCRIPTION
3.1.SYSTEM DESCRIPTION
Delivery Unit for dental purposes, for triggering and controlling the syringe, rotation instruments and
others, providing the best proximity in the work field; ambidextrous (It serves to both right and
left-handed).
Structure of the device built in steel with an injected anti-UV protected ABS housing.
High-glow epoxy flat painting, polymerized in an oven at 250ºC, with corrosion resistant phosphate
treatment and cleaning materials.
Smooth, rounded, light and flexible hoses, without grooves or flutes.
Automatic tip selection, through individual pneumatic valves, providing easiness on triggering.
It has extensive support for incorporated instruments, allowing a better accommodation of the
working material.
Two-sided handles.
Staggered tip supports to avoid an involuntary fall of the instruments, what causes damage to them.

3.2.APPLICATION SPECIFICATION
The Delivery Unit are an instrument support system integrated into the table such as syringe,
hoses and tray.

3.2.1.Operating principles
The operation of Delivery Unit consists of a table that feeds and controls Delivery Unit and has
movement through articulated arms with wide and pneumatic locking.

3.2.2.Significant physical characteristics

The Delivery Unit are constructed using a range of specific materials for each function, such as steel,
cast iron and aluminum in its structure; polyurethane, PVC, steel and plastic in the finishing, etc.

3.2.3.User Profile
The Delivery Unit can be used by both sexes, with the minimum level of literacy with the ability
to read and understand images, symbols, icons, Western characters (Arial font), numerical alpha
characters, and may not present a degree of visual imperfection for reading or vision and average
degree of impairment of recent memory, not being in clear capacity to perform the activities and
functions of the product correctly the profession. The user needs to be a qualified health care
professional and trained to perform the activities, functions frequently used in the application of
Delivery Unit and their functions of primary operations.

19
3.3.PRODUCT MAIN COMPONENTS
3.3.1.Equipo

13
bottom view a

10

09 08 07

12 11
side view b
09
15
15
01

12
17 16 15 14 02
b

03
01 - Bilateral Catcher 05 06
*
02 - Triple syringe
*
03 - High-speed-motor terminals
*
04 - Micro motor terminal 04 a
*
05 - Water activation key in the bowl
*
06 - Control panel (PAD)
*
07 - Negatoscope
08 - Support tools
*
09 - Arm brake valve
*
10 - Bio-System operation
*
11 - Water records for FO/MME/Ultrasound/Bicarbonate Jet
*
12 - LED reversal key (Ultra Vision)
*
13 - Heating water activation key in the syringe
*
14 - Power (power ultrasound adjustment)
*
15 - Speed (electric micro motor power adjustment)
*
16 - Light (electric micro motor brightness adjustment)
*
17 - MME rotation-wise reversal key

*
Optional items
20
3.3.2.Accessories

01 02 03

04 05 06

07 08 09

10 11 12

13 14 15

21
 16 17 18

19 20

*
01 - Terminals:
• Borden
• Midwest
• Fiber Optic
• Electric Micromotor
*
02 - LED curing light
*
03 - Control Panel Kit (PAD)
• Available in two versions (11 / 17 keys)
*
04 - 3-way syringe with body fully injected in thermoplastic
*
05 - 3-way syringe with fully metallic body or with handle injected in thermoplastic
*
06 - Auxiliary tray / instrument holder
*
07 - Stainless Steel Top
*
08 - Bicarbonate jet kit (model with terminal and reservoir coupled to the Equipo)
*
09 - Bicarbonate Jet Kit (Jet Hand model)
*
10 - CART Coupling
*
11 - Pneumatic FLEX Coupling
*
12 - Mechanical FLEX Coupling
*
13 - "Chip Blower" integrated foot controller
*
14 - Progressive foot controller
*
15 - Progressive foot controller with water activation/cut
*
16 - 3-way syringe heater kit
*
17 - Negatoscope Kit
*
18 - Manometer
*
19 - Ultrasound Kit
• Available in versions with fixed or detachable transducer with or without lighting
*
20 - EMM Kit

Optional Items (Subject to commercial availability)

*

22
The Equipos may be composed of:

Optional Abbreviations

Terminal Borden TB
Terminal Midwest TM
Fiber Optic Terminal FO
Electric Micromotor Terminal EMM
LED curing light OPTI
Control Panel PAD
Bicarbonate Jet JET
CART Coupling C
Pneumatic FLEX Coupling F
Mechanical FLEX Coupling SF
Ultrasound SONIC
Full Equipment FULL◊

Identification label "responsible

field in identifying product
configuration".

Notes
Equipo Composition (setting)
Equipment with "FULL◊" nomenclature may contain some options together, such as: FO/
EMM/OPTI/SONIC/PAD/JET, etc...

23
3.4. PARTS APPLIED
The following item is used in the patient treatment.

Contact
Type of parts Type of contact Classification
duration
Pneumatic Mucous N/A
Detachable 1 min
handpieces membrane
Mucous
Ultrasound Fixed 1 min Type B
membrane
Detachable and Mucous
Electric Micromotor 1 min Type B
fixed membrane
Detachable and Mucous
LED curing light 1 min Type B
fixed membrane
Mucous
Syringe nozzle Detachable 1 min N/A
membrane
*
Not supplied with the product.

3.5. LABELS POSITIONING

The following figure illustrates the labels location on the equipment.

a
a

Illustrative image

24
3.6.SYSTEM REQUIREMENTS
3.6.1.Compressor requirements
The compressor is required to provide compressed air for clinical and laboratory use, having stable
performance and flow capacity according to the minimum requirements required for the installation
of the dental chair, besides being free of oil or emission of fumes, vapors or unpleasant odors.
It must have a valve safety system that comes into operation for pressure release in the event
of a pressure failure and also an overload protector for the purpose of protecting the equipment
from overheating. The location of its installation should be an airy place, preferably outside the
office and should not be installed in sanitary facilities such as bathrooms and toilets, to minimize
contamination of the air used in the dental chairs.
For patient, operator safety and the perfect operation of the product, the compressor installation
must comply with the following recommendations:
Install a pressure relief device with the compressor;
Install air filter with pressure regulator, thus preventing oil, moisture and solid particles from
penetrating inside the dental chair and then reaching its vital parts, for example; valves, handpieces,
etc.;
Install the compressor near the power point to avoid losses;
In the installations preferably use rigid copper pipes. Pipes can also be executed with galvanized
steel tubes, stainless steel, nylon or polyethylene.
Pressure limit of 80 psi; Limit flow rate ≥ 47 Nl/min;
Humidity limit between 40% and 60%;
Oil contamination limit of 0.5 mg/m³;
Particle contamination limit of < 100 particles/m³ (particles of size between 1 and 5μm);
Air quality regulations comply with the laws of each country.

3.6.2.Vacuum pump requirements

The Vacuum Pump is required to have high suction power, to allow the professional a better
visualization of the operative field with reduced risk of aerosol contamination and greater comfort
to the patient, avoiding its constant displacement to the water unit during the clinical procedure.
The proper functioning of the Vacuum Pump is indispensable to ensure infection control in the
dental chair and asepsis of the patient's oral cavity, as it vacuum and drains the residuals from the
mouth out of the dental chair. Larger parts of the solids should be retained in a debris separator,
from which they should be removed daily.
The Vacuum Pump must be installed in a place where it will not be damaged by pressure, temperature,
humidity, direct sunlight, dust or salts. The equipment should not be subjected to tilting, excessive
vibration, or shock (including during transport and handling).
The suction power must be regulated by a stopcock according to the dental chair need and the
motor must have a thermal protector, which turns off the equipment in case of overheating and
prevents the motor from burning.
The Vacuum Pump must have a minimum vacuum pressure of 75 mmHg so that the ejectors have a
sufficient suction power for mouth cavity aspiration and the value for the maximum vacuum pressure
should be 500 mmHg per dental chair installed.
To considerably increase the service life of its components, the materials used in manufacturing
must be highly resistant to corrosion.
For patient, operator safety and the perfect operation of the product, the installation of the Vacuum
Pump must comply with the following recommendations:
The equipment is not designed for use in environments where vapors, flammable anesthetic mixtures
with air, or oxygen and nitrous oxide can be detected;
The equipment must be grounded correctly;
Although this equipment has been designed according to electromagnetic compatibility standards, it

25
can, in very extreme conditions, cause interference with other equipment. Do not use this equipment
in conjunction with other devices that are very sensitive to interference or with devices that create
high electromagnetic disturbances;
Do not submit to plastic parts for contact with chemical substances used in dental treatment
routines.
Such as: acids, mercury, acrylic liquids, amalgams, etc.;
Avoid pouring water or other liquids into the equipment, which could cause short circuits; Before
starting the operation of the Vacuum Pump, make sure that the voltage input cable plug is plugged
into the mains, and that the water supply stopcock is open;
The lack of water will result in damage to the mechanical seal and the Vacuum Pump will not vacuum;
Never use detergent or any sparkling product to clean the vacuum pump suction tubes internally;
Do not modify any part of the equipment. Do not unplug the cable or other connections without need;
Before cleaning the equipment, turn off the master switch;
Do not use micro abrasive material or steel straw in cleaning, do not use organic solvents or
detergents containing solvents such as ether, stain strip, etc.;
To avoid the risk of infection, wear protective gloves when handling filters and drains. Dispose of
contaminated waste and products in biological waste;
Never use sparkling products in suction (Descaling, Detergents, Flotators, etc.), this procedure may
damage the internal parts of the Vacuum Pump motor;
Never use the bleach solution for external cleaning of the Vacuum Pump and/or any equipment,
as this mixture is highly corrosive and may damage metal parts.

26
3.6.3.Installation location

To meet safety standards, do not operate non-medical equipment, such as

personal computers, within the patient area. Outside the patient's area, the
presence of non-medical equipment is acceptable, provided that approved and
certified computer equipment is used.

Computer equipment must be EC approved and must comply with EC 60950-

1:2005 + AMD1:2009 + AMD2:2013 and low voltage and 2014/EU low voltage
and 2014/30/EU guidelines 2014/EU

3.6.4.System layout

*
Do not accompany the product

27
 4
OPERATION

Alliage S/A Industrias Médico Odontológica

Phone: +55 (16) 3512-1212
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 – Ribeirão Preto – SP – Brazil

28
4. OPERATION
4.1.INITIAL PREPARATION

The equipment should be cleaned and disinfected prior to use in a new patient,
observing the instructions contained in this manual.

To insulation the power supply equipment, use the master switch.

Turning on / off the dental set

Turn on the main switch of the Dental Chair. All the functions of the equipment will be enabled. The
main switch has an internal LED which goes on when the dental chair is turned on.

Positioning
The arm has horizontal and vertical movements, with a pneumatic locking device.
Maintaining the button “Arm break valve” pressed, place the delivery unit in the desired position
holding it by the handle, and release it to fasten it in this position.

02 Use of 3-Way Syringe

Press button (01) for water to come out, (02) for air
to come out or both simultaneously to obtain a spray.
Heating water activation*
When triggering the switch key, the Led will go
01 on indicating the syringe’s water heating. The
temperature shall remain around 40ºC. To turn the
heating feature off, position the key again.

Adjustment of Spray of TB/TM high and low rotation terminals

The adjustment is made via a valve positioned in the terminal. Turn it in a
clockwise direction to reduce the spray and in a counterclockwise direction
to increase it.
Note: As the “TB” double terminal does not have a spray this adjustment is not
required.

*
Optional items
29
Adjustment of Spray of “MME/FO
high and low rotation terminals”
The adjustment is made via the valves positioned
under the box of the delivery unit (a). Turn it in
a clockwise direction to reduce the spray and
in a counterclockwise direction to increase it.

a
a Water records

High rotation terminals with double

illumination system "LED selection"*
Select the desired illumination system through the reversal
key.

White light LED LED illumination with material

illumination. exposer (Ultra-Vision).

LED turned off

Water flow activation in the bowl*

For triggering the water in the water unit bowl, press
the key (03), to interrupt, press it again. 03

*
Optional items
30
Terminals activation
Progressive foot controller* (fig.1)
For operate rotating instruments, remove the instrument to b
be used from the stand, activate the control foot controller Fig.1
(b).
Progressive foot controller with chip-blower function/
handpiece water lock system* (fig.2)
For operate rotating instruments, remove the instrument to
be used from the stand, activate the control foot controller Fig.2 e
(b).
To trigger the handpiece water lock system, place the switch b
(d) in Off to unlock. Return to the starting position to lock. d
Pressing the (e) down key will trigger air on the tips.
Foot controller chip-blower* (fig.3)
For operate rotating instruments, remove the instrument to Fig.3
be used from the stand, activate the control foot controller
(b).

The power (air supply) can be controlled by the operator

with greater or lesser pressure on the foot controller lever (a).
e
The "chip-blower" system allows the release of airflow with
the turbine down (air function).
Pressing the (e) down key will trigger air on the tips. Pressing
the (e) down key and shifting the lever (a) to the right
together will trigger the high-speed air and water turbine
(spray).

Triggering through the control panel kit (PAD)*

01 Note
The configuration of the equipment without the control
02 panel does not interfere with the operation of the product.

03 04 01 - Activation of the dental light

02 - Work position “1”
05 03 - Work position “2”
04 - Work position “3”
06 05 - Initial position
06 - Rise seat
08 09
07 - Lower seat
08 - Rise backrest
07 09 - Lower backrest

*
Optional items
31
Reflector activation
Press and release the key (01) to turn the Reflector on or off.
To switch the light intensity of the Reflector, hold down the key until the Reflector reaches the
desired intensity.

Work positions
The Equipo panel has programmable working positions. To program, simply place the chair in position
and reflector at the desired intensity and keep the key of the chosen working position pressed for 3
seconds, the chair will emit a long beep determining that the position has already been programmed.

Automatic movement to position back to zero - V0

Press the key (05) so that the seat and backrest simultaneously return to zero. This is the most
comfortable position for the patient to get in/out the Chair.
To stop the movement, activate the foot controller in any direction or quickly press the key (05).
The reflector will automatically turn off after pressing the key (05).

Returns to the last position "Spitting Position**"

When you press the "Return to the last "Spitting Position" button (08), the reflector will turn off (if
it is on), start the water flow in the bowl (until the set time or if you have not programmed for 30
seconds) and the backrest will fully rise to the Spit Position, when you turn it back on, the backrest
will return to the previous position and the reflector will turn on.

Emergency stop**
When you press the "Emergency Stop" button (17), the Emergency Led will light up and an automatic
stop of all movements of the chair will occur, being locked until the "Emergency Stop" button is
pressed again (17). This operation does not cancel the positions and schedules already recorded.
We recommend using it during long surgical procedures, as the chair will be blocked, preventing
unexpected movements.

Programming water in cup holder/bowl**

To program the water flow time in the cup holder (10)/bowl (09), hold down the corresponding key,
3 short beeps will be emitted indicating the programming mode.
Release the key after the desired time interval. The flow time is recorded.
The maximum programming time is 60 seconds, exceeding this limit an error beep will be emitted
indicating that the time has not been scheduled.

Concealable arm activation**

To release the fall of the arm, press the key (11).

How to supply the reservoirs (syringe water / tips)

Remove the reservoir by unscrewing it and make the water reset. After restarting, replace it.
Always use filtered water or aseptic products.

**
Functions available for PAD
control panel 17 keys.

32
Bio-System*
Remove the reservoir by unscrewing it and make the replacement. Use chlorinated water solution 1:500.
The preparation of the solution is done as follows: from a solution of 1% sodium hypochlorite a solution
is prepared a solution of chlorine at 500 p.p.m.
How to prepare the solution: use 25 ml of 1% sodium hypochlorite solution and dilute in 500 ml of
water (1 to 20). This solution should be prepared daily.

Warning
- Strictly follow this ratio to avoid equipment damage and an efficient disinfection result.

Bio-System Activation*
Remove the handpieces from the terminals. Take the handpiece
terminals to the sink or bowl of the water unit.
Fully open terminals spray stopcocks. Activate the Bio-System
activation key for a few seconds to internally disinfect the
components of the Equipo with bactericidal liquid.
Then, press the foot control for a few seconds to rinse, to
eliminate the chemical residues of the bactericidal liquid retained
internally in the components of the Equipo.

Warning
- This procedure must be done at the beginning
of the day and after each patient.

LED curing light*

a b c

click

a - Before using, please b - Insert the light conductor c - Insert the eye protector
sterilize the light conductor, into the handpiece until you into the light conductor.
disinfect the handpiece and hear a slight click and feel that
the cable. it has fitted correctly.

Attention
Always keep the light conductor protected by disposable PVC film that must be changed
for each patient. This procedure protects the light conductor against scratches and the
accumulation of undesirable residues.

*
Optional items
33
- Press the button to turn on the equipment (01)
- Select the application mode by pressing the selection button (02), the 04
variations of which are:
- Continuous: Maximum and continuous light intensity mode (same
luminosity
from the beginning to the end of the polymerization).
01
- Ramp: Gradually light intensity increases gradually.
- Pulsed: Pulsed mode are cycles that oscillate at a fixed frequency.
• The chosen application mode will be shown on the display. 02
• To program the time, press the button (03) and choose the time from 5
to 20 seconds, which will be shown on the display (04).

Use the polymerization time recommended by the composite resin 03

manufacturer and always perform restorations in incremental layers with
a maximum thickness of 2mm.

d e
2mm

beep

d - After selecting the application e - To start the polymerization

mode and choosing the time, cycle, press the trigger button.
remove the protective cover from To interrupt, just press again.
the light conductor, bring the
handpiece to the patient's mouth
and position the light conductor at
a safe distance.

Warnings
- Never direct the beam of blue light at your eyes;
- Protect the visual field using the Eye Protector;
- The Eye Protector has the objective of filtering only the blue light that acts in the
photopolymerization of resins to protect the vision and still allows the ambient lighting to
pass into the operative field.

Auto shutdown:
The equipment will automatically turn off when not in use for more than 3 minutes. To turn
it back on, press the power button.

Use of the bicarbonate jet *

The bicarbonate jet removes dark stains from the teeth, caused by cigarettes, coffee, tea, etc.,
associated with bacterial plaques and not with calculus.
To obtain the best result from the bicarbonate jet, we recommend respecting the distance of the
handpiece in relation to the tooth (5mm), with an inclination of 30º to 45º describing small circular
movements on the teeth.
To avoid unpleasant sensations in patients, the jet of bicarbonate should be directed to the occlusal
edge and not to the gingival sulcus.

*
Optional items
34
 Warning
- This equipment is contraindicated for use in patients who have serious respiratory or renal
disorders or who are undergoing hemodialysis, these cases must have medical monitoring.
We recommend the use of a mask and glasses for the application of the bicarbonate jet.

Remove the top cap (a) by unscrewing it and add enough sodium bicarbonate for a section of
prophylaxis, that is, 20 to 40g (do not exceed the level indicated on the container). The bicarbonate
level is visible through the transparent container (e). To remove the leftover bicarbonate powder,
unscrew the container (e) and clean it.

a
Warning
- Do not add more than 40g of
bicarbonate to the container,
as this may cause clogging of
the powder outlet. The level of
bicarbonate is visible through
the transparent container.

The volume of water and air flow can be regulated according to the need, as follows:
Direct the handpiece of the bicarbonate jet to a container (01) (Ex: spittoon, sink bowl, etc.).
Activate the foot control (02) and proceed with the water volume adjustments “through the
corresponding stopcock (a)”. The amount of water in excess will decrease the effect of the powder
due to washing. Decreasing the water too much will cause the powder to become more aggressive.

Warning
The effectiveness depends on the perfect dosage
of the water volume and the amount of powder.

01

02
a

a Water records

*
Optional items
35
Ultrasound activation*
Remove the ultrasound handpiece from the holder;
Choose the appropriate insert for the desired operation according to "Techniques and Applications";
Screw the chosen insert onto the handpiece with the help of the fixation wrench (01) and a small
tightening;
Activate the progressive foot controller (02).
Position the power selector (b) according to the sensitivity of the operation.
Regulate the water flow through the corresponding stopcock (a).
At the end of the procedure, release the foot controller (02) and place the handpiece on the holder.

01

Function available on the side panel when the equipo

presents ultrasound in its configuration.

02

03
a

a Water records Warning

- Do not leave the handpiece with an insert in
the tip holder to avoid accidents.

Note (important recommendation)

The shape and weight of each insert are determining factors to obtain maximum performance from
the ultrasound generator, the operator's attention to these two characteristics, will ensure the
maintenance of the best performance of the unit, however, we recommend that the structure of
the insert is not altered (by filing or twisting it), in the same way the aging of an insert leads to a
change of its original characteristic, making it ineffective.
Any insert that has been damaged by use or accidental impact must be replaced.

*
Optional items
36
Techniques and applications
All ultrasound inserts have the particularity of vibrating in
a single plane (vibrations from front to back, and on the
axis of the insert).
The lateral vibrations common to other scalers do not
exist, the straight displacement favors a more precise
approximation of the tooth and gum.
Enamel and cement are protected from unnecessary shock.
Within this main plane of vibration, the end of each insert
is driven by small vibratory movements.
To obtain the maximum performance of the ultrasound,
the operator must consider the vibration settings specific
to each insert.

Periodontic
Better angle and longer length
Tips indicated for the removal of dental
calculus on all surfaces of the supra and
sub gingival teeth.
Perio E* Perio Sub

Perio Supra

Endodontics
Tips for removing fractured instruments,
removing intra-root pins, cements, etc.

Remo N* Remo C*

Endo G* Endo L*

*
Optional items
(Subject to commercial availability)
37
4.2.ELECTRIC MICROMOTOR ACTIVATION

Direction of rotation

Program 1 Speed indication in rpm

Plus and Minus key

Forward/backward operation
key

Program keys

To start the micromotor, position the equipo rod forward (a), where the terminal for the electric
micromotor is attached and choose the rotation speed:

RPM % b
a
40,000 100
30,000 75
20,000 50
10,000 25
4,000 10
2,000 5
ON OFF
Micromotor rod displaced Micromotor rod in initial
forward position

*
Optional items
38
 5
CLEANING, DISINFECTION AND STERILIZATION

Alliage S/A Industrias Médico Odontológica

Phone: +55 (16) 3512-1212
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 – Ribeirão Preto – SP – Brazil

39
5. CLEANING, DISINFECTION AND STERILIZATION

Before starting the cleaning and disinfection procedure, turn off the equipment
main switch to avoid permanent damage.

For your protection, during the process of cleaning and disinfecting the
equipment, use PPE such as disposable gloves and goggles.

The cleaning and disinfection process must be performed at each patient change.
When starting the process, check for visible dirt, such as blood or saliva.
Carefully clean the patient's entire contact area, such as upholstery lining. For cleaning use a clean,
soft cloth moistened with mild soap and then dry with a clean, soft cloth or paper towel.
For the disinfection process of the equipment, use disinfectant detergent foam that has active
components based on didecyldimethylammonium chloride.
Apply the disinfectant detergent foam on the surface or on a clean cloth and spread it over the surface
to be treated. Respect the antimicrobial contact time specified by the manufacturer.
After application, allow to dry. Do not rinse off.
Some of the removable parts that come in contact with the patient can be autoclaved. These parts are:
Syringe nozzle, ultrasound cover, LED curing light tip, contra-angle, straight piece, high rotation, Tips.

All accessories suitable for sterilization must be sterilized only in an autoclave

at 135 °C with at least 3 minutes of waiting time and with a pressure of 2.2 bar.

If these items are autoclaved, disinfection by alternative methods is not necessary.

There is no limit on cycles or application time that the equipment and its parts can tolerate during
the cleaning, disinfection and/or sterilization process, following the instructions in this manual.

Do not spill liquid disinfectant on the equipment.

Do not use organic solvents, for example, thinner, to clean the equipment. In the
event that the developer solution is spilled on the panel, clean it immediately,
as these solutions may compromise the equipment's paint.

Sterilization parameters must always be followed.

Accessories that are not properly sterilized can cause disease in patients.

40
 6
PROBLEMS DIAGNOSTICS

Alliage S/A Industrias Médico Odontológica

Phone: +55 (16) 3512-1212
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 – Ribeirão Preto – SP – Brazil

41
6. PROBLEMS DIAGNOSTICS
6.1.TROUBLESHOOTING
In case you encounter any problem in the operation, follow the instructions below to check and fix
the problem, and/or contact your representative.

Unforeseen incident Probable Cause Solutions

- Handpiece does not work. - Compressor off. - Start the compressor.

- Handpiece with low rotation. - Dental chair supply pressure - Adjust the supply pressure
below specified (80 PSI). (80 PSI).

- There is no water in the han- - Air deficiency in the com- - Regularize air supply.
dpieces spray. pressor. - Fill the reservoir with filtered
-0Lack of water in the reservoir. water.
- Open the terminal.
-0Handpiece coupling terminal
closed.

- There is no water in the -0Lack of water in the reservoir. - Fill the reservoir with filtered
syringe. water.
-0Compressor off. - Start the compressor.

- When activating the Bio- -0L ack of liquid in the Bio- - Fill the reservoir with bacte-
-System, no bactericidal liquid -System reservoir. ricidal liquid.
comes out of the handpiece -0Chair fuse blown. - Turn off the power to the
terminals. chair and request the presence
of a Technician.
-0Chair master switch off. - Turn on the Chairs main
switch.
- Negatoscope viewer does - Chair fuse blown. - Turn off the power to the
not work. chair and request the presence
of a Technician.
-0Chair master switch off. - Turn on the Chairs main
switch.

- LED curing light completely - Lack of electricity. - Check the electrical network.
inoperative. - Chair fuse blown. - Turn off the power to the
chair and request the presence
of a Technician.

- The equipment is not polyme- - Resin not suitable for the - Acquire resin suitable for the
rizing the resins. wavelength range of LED curing LED curing light wavelength,
lights. that is, it contains photoini-
tiators with camphorquinone.

- The ultrasound does not work. - Blown fuse. - Turn off the power to the
chair and request the presence
of a Technician.

42
 Unforeseen incident Probable Cause Solutions
- Lack of power in the ultra- - Deformed insert. - Replace the insert.
sound. -0Loose insert. -0Tighten the insert with the
-0Misuse (incorrect attack an- wrench.
gle). -0S ee item “Techniques and
applications”.

- There is no water in the han- - Inadequate water supply - Correct the water pressure.
dpieces. pressure. - Adjust the water flow throu-
- Poor regulation of the water gh the Ultrasound water re-
flow. gister.

If problems persist, contact the Alliage Service Department.

43
 7
INSPECTION AND MAINTENANCE

Alliage S/A Industrias Médico Odontológica

Phone: +55 (16) 3512-1212
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 – Ribeirão Preto – SP – Brazil

44
7. INSPECTION AND MAINTENANCE

Maintenance or service procedures may only be carried out by a technical

service authorized by the manufacturer.

All instructions for using the equipment as intended are provided in this user guide. If a problem is
detected and cannot be corrected with the instructions in the problem diagnostics section, contact
the Alliage Service Department.

7.1.PERIODIC INSPECTION
It is imperative that this equipment be inspected regularly to ensure operational safety and functional
reliability. This inspection must be carried out by personnel familiar with the necessary precautions
to avoid exposing the patient to risk.
Periodic inspection should be carried out at regular intervals (at least once a year) to ensure that
the product is permanently safe and operational. All components subject to normal wear and tear
should be checked and, if necessary, replaced.
The manufacturer and the assembler/installer are exempt from responsibility for the standard results
not being compliant in cases where the user does not perform the maintenance recommended by
the manufacturer.
Neither inspection nor service is part of the equipment's warranty.
Maintenance performed must be documented and maintained with the equipment.
The table below gives a description of the main inspection items and recommended frequency.

Item Inspection description Recommended frequency

Safety system Collision, Warning lights, and Interlock. Daily
Electrical parts Overheating/Noise/Burning smell Monthly
Elevation Operation/Noise/Vibration Annual
Movement
Operation/Noise/Vibration Annual
mechanism
Foot controller
Operation/Damage Annual
and Controls

If problems are detected during the inspection, contact the Alliage Service Department.

7.2.PREVENTIVE MAINTENANCE
In addition to the annual inspection, to ensure a long service life and plain operation of your
equipment, it is important to carry out preventive maintenance for a maximum period of three (3)
years.
Contact the Alliage Service Department about our periodic overhaul and preventive maintenance
program.

45
7.3.CORRECTIVE MAINTENANCE

To repair or replace any part or part see instructions in the service manual.

Corrective maintenance cannot be performed by the user.

Do not open the equipment or try to repair it yourself or with the help of
someone without training or authorization. This can aggravate the problem or
produce a failure that can compromise the safety of the equipment.

The power cables, electronic boards, fuses and belts can be changed only by
the authorized technician. See service manual for connection and anchoring
information.

The equipment or any of its parts cannot be maintained or serviced during

use with a patient.

The equipment contains parts under high voltage. Risk of electric shock. Turn
off the main switch before servicing.

Moving parts can cut or crush.

The service manual is only available for Authorized Technical Assistance.

Alliage declares that the provision of circuit diagrams, component lists or any other information that
provides technical assistance on behalf of the user, can be requested as long as previously agreed
between the user and Alliage.
The warranty will be void if the original parts are removed/replaced by unauthorized service
technicians.

46
7.4.ALLIAGE AUTHORIZED SERVICE NETWORK
All services performed on the Alliage equipment must be performed by an Authorized Technical
Assistant, as otherwise they will not be covered by the warranty.
If you need to request electrical diagrams and or specification of components that is not stated in
the user manual, use the Alliage Customer Service to make the request.

Phone: +55 (16) 3512-1212

Address: Rodovia Abrão Assed, Km 53 - Recreio Anhangüera - Ribeirão Preto-SP / Brazil -
Zip Co 14097-500

47
 8
WARRANTY

Alliage S/A Industrias Médico Odontológica

Phone: +55 (16) 3512-1212
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 – Ribeirão Preto – SP – Brazil

48
8. WARRANTY
This equipment is covered by the warranty periods, terms and conditions contained in the Warranty
Certificate that comes with the product.

49
 9
STANDARDS AND REGULATIONS

Alliage S/A Industrias Médico Odontológica

Phone: +55 (16) 3512-1212
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 – Ribeirão Preto – SP – Brazil

50
9. STANDARDS AND REGULATIONS
This equipment has been designed and manufactured to meet the following standards:

ABNT NBR IEC 60601-1:2010 Medical Electrical Equipment - Part 1: General basic safety
Amendment 1: 2016 requirements and essential performance.
Medical Electrical Equipment, Part 1-2: General requirements
for basic safety and essential performance - Collateral
ABNT NBR IEC 60601-1-2:2017
standard: Electromagnetic interference - Requirements
and tests.
General requirements for basic safety and essential
ABNT NBR IEC 80601-1-60:2015
performance of dental equipment
Electromedical equipment - Part 1-6: General requirements
ABNT NBR 60601-1-6:2011 for basic safety and essential performance - Collateral
standard: Usability;
Health products - Application of usability engineering to
ABNT NBR IEC 62366:2016
health products;
Medical electrical equipment - Part 1-9: General
requirements for basic safety and essential performance
IEC 60601-1-9:2014
- Collateral standard: Requirements for environmentally
conscious design
IEC 62304:2006 Medical device software - Software life-cycle processes.
ISO 9680:2014 Operating lights
Dentistry – Dental units – Part 1: General requirements
ISO 7494-1:2018
and test methods
Dental units – Part 2: Air, water, suction and wastewater
ISO 7494-2:2015
systems
ABNT NBR ISO 6875:2014 Dental patient chair
ISO 9687:2015 Graphical symbols for dental equipment
Graphic symbols for electrical equipment in medical
ISO 15223-1:2016
practice
EN 1041:2008+A1 2013 Information provided by the medical device manufacturer.
Biological assessment of medical devices - Part 1:
ABNT NBR ISO 10993-1:2013
Assessment and testing.
Medical devices - Application of risk management to
ABNT NBR ISO 14971:2009
medical devices.
Quality management systems - Requirements for
ABNT NBR ISO 13485:2016
regulatory purposes

51
 10
TECHNICAL SPECIFICATIONS

Alliage S/A Industrias Médico Odontológica

Phone: +55 (16) 3512-1212
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 – Ribeirão Preto – SP – Brazil

52
10. TECHNICAL SPECIFICATIONS
10.1. EQUIPMENT CLASSIFICATION
Class of classification according to ANVISA
Class II
Class of classification according to CE/FDA
Class I
Equipment classification according to EN IEC 60601-1
Product classification for applied parts - Type B
Protection Against Electric Shock - Class I
Protection Against Harmful Water Penetration
IP00 - Product not protected against harmful penetration of water and particulate matter
Degree of safety of application in the presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide
Unsuitable equipment
Operating Mode
Non-continuous operation
Handpieces
Operating Time:
Ton: 1 min. / Toff: 4 min.

10.2. APPLIANCE INFORMATION (GENERAL)

Supply mains voltage (from the chair)
24 V~
Power supply frequency
50 / 60 Hz
Allowable fluctuation
+/- 10 %
Power consumption
30 VA
Equipo net weight
15 kg
Equipo gross weight
20 kg

53
10.3.SPECIFIC INFORMATION
Air pressure (from the chair)
80 PSI (5.52 BAR)
Air input pressure Syringe
40 PSI (2.76 BAR)
Maximum air consumption (from the chair)
80 l/min
Water tank capacity (from the water unit)
1000 ml
High speed air consumption
32 L/min
High speed water consumption
42 ml/min
Syringe air consumption
17 L/min
Syringe water consumption
100 ml/min
Maximum load capacity applied to the tray holder
1 kg
Dimensional tray holder
385 x 300 mm

10.4.LED CURING LIGHT SPECIFICATION

Power
5.2 VA
Light source
1 LED
Active medium
Semiconductor LED (InGaN)
Wavelength
440nm – 460nm
Timer
60 seconds

54
10.5.ULTRASOUND SPECIFICATIONS
Ultrasound Vibration Frequency
29,000 Hz
Consumption of irrigating liquid
28 ml/min
Power consumed
15 VA
Transducer system
Electric piezo ceramic

10.6.ENVIRONMENTAL CONDITIONS
Environmental Conditions for Transportation and Storage
Transport or storage ambient temperature range
-12ºC to + 50ºC
Transport and storage relative humidity range
< 85% RH
Atmospheric pressure range
700 hPa to 1060 hPa
(525 mmHg to 795 mmHg)

Environmental installation and operating conditions

Ambient operating temperature range
+ 10ºC to + 35ºC
Operating relative humidity range (non-condensing)
< 75% RH
Atmospheric pressure range
700 hPa to 1060 hPa
(525 mmHg to 795 mmHg)
Operating altitude
≤ 2000 m

55
10.7.EQUIPMENT DIMENSIONS
Delivery Unit with CART coupling

Delivery Unit with FLEX pneumatic coupling

Delivery Unit with FLEX Mechanical coupling

56
 11
ELECTROMAGNETIC COMPATIBILITY

Alliage S/A Industrias Médico Odontológica

Phone: +55 (16) 3512-1212
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 – Ribeirão Preto – SP – Brazil

57
11. ELECTROMAGNETIC COMPATIBILITY
The Delivery Unit are intended for use in the electromagnetic environment specified below.
The buyer or user should ensure that it is used in such an environment.
The Delivery Unit are suitable for use in a professional health care environment, not including areas
where sensitive equipment or sources of intense electromagnetic disturbances are present, such as
the RF shielded room of a magnetic resonance imaging system in operating rooms close to active
AF surgical equipment, electrophysiology laboratories, armored rooms or areas where short wave
therapy equipment is used.
The following tables provide information on the equipment's compliance with the ABNT NBR IEC
60601-1-2: 2017 standard.

11.1.ORIENTATION AND DECLARATION FOR ELECTROMAGNETIC EMISSIONS

Emission test Compliance Electromagnetic Environments -
guidelines
RF emissions CISPR 11 Group 1 The Delivery Unit use RF energy only for
their internal functions. Therefore, their
RF emissions are very low and are not
likely to cause any interference in nearby
electronic equipment.

RF emissions CISPR 11 Class A

The Delivery Unit are suitable for use in
Harmonic emissions IEC 61000- Class A
all establishments except domestic and
3-2
those directly connected to the public low
Voltage fluctuations/flicker Complies voltage power supply network that powers
emissions IEC 61000-3-3 buildings used for domestic purposes.

Note: The emission characteristics of this equipment make it suitable for use in industrial areas
and hospitals (IEC/CISPR 11, Class A). If used in a residential environment (for which IEC/CISPR
11, Class B is normally required), this equipment may not provide adequate protection for radio
frequency communication services. The user might need to take mitigation measures, such as
relocating or re-orienting the equipment.

58
11.2.ORIENTATION AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY

Basic EMC standard or

Phenomenon Immunity test level Compliance level
test method

Electrostatic discharge IEC 61000-4-2 ± 8 kV contact ± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV, ± 2 kV, ± 4 kV, ± 8
± 15 kV air kV, ± 15 kV air

Irradiated RF EM fields IEC 61000-4-3 3 V/m 3 V/m

80 MHz - 2.7 GHz 80 MHz – 2,7 GHz
80 % AM at 1 kHz 80 % AM a 1 kHz

Fields in proximity from RF IEC 61000-4-3 See Table See Table

wireless communications
equipment
IEC 61000-4-4 ± 2 kV ± 2 kV
AC power input 100 kHz repeat 100 kHz repeat
Fast / saved electrical frequency frequency
transients IEC 61000-4-4 ± 1 kV ± 1 kV
signal input/output 100 kHz repeat 100 kHz repeat
frequency frequency
Line-to-line Outbreak IEC 61000-4-5 ± 0.5 kV, ± 1 kV ± 0.5 kV, ± 1 kV

Ground-Line Outbreak IEC 61000-4-5 ± 0.5 kV, ± 1 kV, ± ± 0.5 kV, ± 1 kV,
2 kV ± 2 kV
IEC 61000-4-6 3V 3V
0.15 MHz - 80 MHz 0.15 MHz - 80 MHz
Conducted disturbances 6V in ISM bands 6V in ISM bands
induced by RF fields between 0.15 MHz between 0.15 MHz
and 80 MHz 80% AM and 80 MHz 80 %
at 1 kHz AM at 1 kHz
Magnetic fields at declared IEC 61000-4-8 30 A/m 30 A/m
power frequency 50 Hz or 60 Hz 50 Hz or 60 Hz
IEC 61000-4-11 0 % UT; 0.5 cycle 0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°, At 0°, 45°, 90°,
180°, 225°, 270° and 135°, 180°, 225°,
315° 270° and 315°
Voltage dips
0 % UT; 1 cycle 0 % UT; 1 cycle
and 70% UT; 25/30 and 70
cycles % UT; 25/30 cycles
Single phase: at 0° Single phase: at 0°
IEC 61000-4-11 0% UT; 250/300 The device will
cycles turn off and/or
reboot if power is
Voltage interruptions
interrupted for five
seconds.

59
NOTE 1 At 80 MHz and 800MHz, the highest frequency range is applicable.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
NOTE 3 UT is the voltage of the AC electrical network before the application of the test level.

Proximity fields from wireless RF communications equipment

Test Maximum Immunity

Band Distance
frequency Service Modulation Power test level
(MHz) (m)
(MHz) (W) (V/m)

385 380-390 TETRA 400 Pulse 1.8 0.3 27

modulation
18Hz
450 430-470 GMRS 460, FM deviation 2 0.3 28
FRS 460 of ± 5 kHz
Senoidal of
1kHz
710 704-787 LT E B a n d Pulse 0.2 0.3 9
13, 17 modulation
745
217Hz
7480
810 800-960 GSM Pulse 2 0.3 28
800/ 900, modulation
870
TETRA 800, 18Hz
930 iDEN 820,
CDMA 850,
LTE Band 5
1720 1700 -1990 GSM 1800; Pulse 2 0.3 28
CDMA modulation
1845
1900; GSM 217Hz
1900; DECT;
LTE band
1970
1, 3, 4, 25;
UMTS
2450 2400-2570 Bluetooth, Pulse 2 0.3 28
WLAN modulation
802.11 217Hz
b/g/n, RFID
2450, LTE
Band 7
5240 5100 - 5800 WLAN Pulse 0.2 0.3 9
802.11 a/n modulation
5500
217Hz
5785

60
List of used cables

Cables Description Width

Power Supply Tripolar Power Cable Gauge 3x 2.50 mm², 250V AC, Male 3m
Plug 20A NBR 14136 2P+T, no female plug, Inmetro.

The Delivery Unit are intended to assist health professionals, and it is for dental
use only. In case of EMC disturbances the operator may experience loss of
communication between the equipment and controls.

Compliance with EMC and EMI standards cannot be guaranteed by the use of
altered cables or cables that do not meet the same standards as the equipment
has been validated.

The use of this equipment adjacent to other equipment should be avoided as

this may result in improper operation. If this use is necessary, it is advisable
that this and other equipment be observed to verify that they are operating
normally.

Do not use accessories, transducers, internal parts of components and other

cables other than those previously specified by the manufacturer. This may
result in increased emission or decreased electromagnetic immunity and result
in improper operation.

Portable RF communication equipment (including peripherals such as antenna

cables and external antennas) should not be used less than 30 cm from any part
of the equipment, including cables specified by the manufacturer. Otherwise,
performance degradation of this equipment may occur.

To maintain basic safety against electromagnetic disturbances during the

expected service life, always use the equipment in the specified electromagnetic
environment and follow the maintenance recommendation described in this
manual.

Pins, connector sockets, or elements bearing the ESD warning symbol must not
be touched or interconnected without ESD protection measures.

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