Anthos A3 Plus User manual

97055344
Rev. 00
2023-01
OPERATOR'S MANUAL
A3 PLUS - A5 - A6 PLUS - L6
SURGICAL SINGLE CART
EN
.

A3 PLUS - A5 - A6 PLUS - L6
SURGICAL SINGLE CART
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EN
Contents
1. GENERAL WARNINGS................................................................................................................................................................................... 4
1.1. SYMBOLS...................................................................................................................................................................................................4
1.2. INTENDED USE .........................................................................................................................................................................................5
1.2.1. CLASSIFICATION AND REFERENCE STANDARDS ........................................................................................................................6
1.2.2. ENVIRONMENTAL CONDITIONS......................................................................................................................................................7
1.2.2.1. STORAGE CONDITIONS...................................................................................................................................................................7
1.2.3. WARRANTY.......................................................................................................................................................................................7
1.2.4. DISPOSING THE EQUIPMENT WHEN NO LONGER USED.............................................................................................................7
1.3. SAFETY WARNINGS..................................................................................................................................................................................8
1.4. ELECTROMAGNETIC SAFETY..................................................................................................................................................................9
1.5. CLEANING AND DISINFECTION..............................................................................................................................................................10
1.6. STERILISATION.......................................................................................................................................................................................11
1.7. NETWORK AND DATA SECURITY..........................................................................................................................................................11
1.8. AUTHORISED AGENTS...........................................................................................................................................................................11
2. DESCRIPTION OF THE EQUIPMENT........................................................................................................................................................... 12
2.1. IDENTIFICATION PLATES.......................................................................................................................................................................12
2.2. DENTAL UNITS........................................................................................................................................................................................13
2.3. DENTAL CHAIR........................................................................................................................................................................................17
2.4. SPECIAL WARNINGS ..............................................................................................................................................................................18
3. STARTING..................................................................................................................................................................................................... 19
3.1. CONVERSION OF THE DENTAL UNIT CONFIGURATION FOR LEFT-HANDED OPERATORS (HYBRID models only).........................20
4. DENTAL CHAIR OPERATION ...................................................................................................................................................................... 21
4.1. SAFETY DEVICES....................................................................................................................................................................................21
4.2. MOVEMENT LOCK DEVICES ..................................................................................................................................................................23
4.3. ADJUSTABLE HEADREST.......................................................................................................................................................................23
4.4. MOVABLE ARMRESTS (OPTIONAL).......................................................................................................................................................24
4.5. PATIENT SENSOR...................................................................................................................................................................................24
5. DENTIST'S BOARD OPERATION................................................................................................................................................................. 25
5.1. DENTIST’S CONTROL CONSOLE ...........................................................................................................................................................28
5.1.1. MAIN SETTINGS .............................................................................................................................................................................31
5.1.1.1. HYGIENE CYCLE SETTING............................................................................................................................................................31
5.1.1.1.1. QUICK FLUSHING CYCLE SETTING (LCD Touch console only).........................................................................................31
5.1.1.1.2. LONG FLUSHING CYCLE SETTING (LCD Touch console only)..........................................................................................32
5.1.1.1.3. BIOSTER DISINFECTION CYCLE SETTING (LCD Touch console only)..............................................................................32
5.1.1.2. STOPWATCH (LCD Touch console only).........................................................................................................................................33
5.1.2. OPERATOR SELECTION (LCD Touch console only).......................................................................................................................33
5.1.3. DENTAL CHAIR "RINSING POSITION" AND "RESET POSITION" PROGRAMMING......................................................................33
5.1.4. PROGRAMMING THE DENTAL CHAIR POSITIONS A, B, C and D................................................................................................34
5.1.5. EMERGENCY BUTTON...................................................................................................................................................................34
5.1.6. TURNING ON THE OPERATING LIGHT..........................................................................................................................................34
5.1.7. CONSOLE CONTROL PANEL LOCKING BUTTON.........................................................................................................................35
5.2. FOOT CONTROL......................................................................................................................................................................................35
5.2.1. "MULTIFUNCTION” FOOT CONTROL.............................................................................................................................................35
5.2.2. "PUSH-PEDAL” FOOT CONTROL...................................................................................................................................................37
5.2.3. "POWER PEDAL" FOOT CONTROL................................................................................................................................................39
5.2.4. WIRELESS FOOT CONTROL..........................................................................................................................................................41
5.3. SYRINGE..................................................................................................................................................................................................43
5.4. TURBINE..................................................................................................................................................................................................44
5.4.1. TURBINE (SINGLE WATER UNIT models)......................................................................................................................................45
5.5. ELECTRIC MICROMOTOR ......................................................................................................................................................................46
5.5.1. RESTORATIVE OPERATING MODE...............................................................................................................................................48
5.5.2. ENDODONTIC OPERATION MODE (LCD Touch console only) ......................................................................................................48
5.5.3. ELECTRIC MICROMOTOR (SINGLE WATER UNIT models) ..........................................................................................................50
5.6. SCALER....................................................................................................................................................................................................51
5.6.1. SCALER (SINGLE WATER UNIT models) .......................................................................................................................................53
5.7. T LED CURING LIGHT..............................................................................................................................................................................54
5.8. C-U2 DENTAL CAMERA...........................................................................................................................................................................58
5.8.1. C-U2 INTRAORAL CAMERA (DIGIT console)..................................................................................................................................62
5.8.2. C-U2 INTRAORAL CAMERA (SINGLE WATER UNIT models)........................................................................................................64
5.9. ELECTRONIC APEX LOCATOR...............................................................................................................................................................66
5.10. ZEN-Xi INTEGRATED SENSOR...............................................................................................................................................................68
6. ASSISTANT’S BOARD OPERATION............................................................................................................................................................ 69
6.1. ASSISTANT’S BOARD CONSOLE ...........................................................................................................................................................71
6.2. INSTRUMENTS ON ASSISTANT’S BOARD.............................................................................................................................................72
6.3. SUCTION TUBES.....................................................................................................................................................................................73
6.4. TRAY HOLDER.........................................................................................................................................................................................74
6.5. HYDRAULIC SALIVA EJECTOR...............................................................................................................................................................74
7. WATER UNIT OPERATION........................................................................................................................................................................... 75
7.1. FILL CUP AND BOWL ..............................................................................................................................................................................75

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7.2. S.H.S. SYSTEM (SIMPLIFIED HYGIENIZATION SYSTEM)......................................................................................................................79
7.2.1. MANUAL S.H.S. SYSTEM................................................................................................................................................................80
7.2.2. MANUAL DISINFECTION CYCLE WITH S.H.S. SYSTEM...............................................................................................................81
7.3. W.H.E. SYSTEM (WATER HYGIENIZATION EQUIPMENT).....................................................................................................................82
7.4. BIOSTER DISINFECTION AUTOMATIC SYSTEM ...................................................................................................................................84
7.5. AUTOMATIC INSTRUMENT FLUSHING CYCLE......................................................................................................................................86
7.6. A.C.V.S. SYSTEM (AUTOMATIC CLEANING VACUUM SYSTEM) ..........................................................................................................88
7.7. OPENING/CLOSING THE WATER UNIT SIDE COVER...........................................................................................................................89
7.8. WATER UNIT LED (optional) ....................................................................................................................................................................90
8. ACCESSORIES............................................................................................................................................................................................. 91
8.1. OPERATING LAMP ..................................................................................................................................................................................91
8.2. MONITOR ON LAMP POLE......................................................................................................................................................................91
8.3. NEGATOSCOPE FOR PANORAMIC X-RAYS..........................................................................................................................................91
8.4. AIR/WATER/230V QUICK-COUPLINGS...................................................................................................................................................92
8.5. AUXILIARY TRAY HOLDER .....................................................................................................................................................................92
9. MAINTENANCE............................................................................................................................................................................................. 93
9.1. MAINTAINING THE INSTRUMENTS ........................................................................................................................................................93
9.2. DRAINING CONDENSATE.......................................................................................................................................................................94
9.3. SUCTION FILTER CLEANING..................................................................................................................................................................95
9.4. SUCTION LINES.......................................................................................................................................................................................96
9.5. AIR-LIQUID SEPARATOR CANISTER BY CATTANI................................................................................................................................97
9.6. CLEANING THE TURBINE RETURN AIR FILTER....................................................................................................................................98
9.7. METASYS AMALGAM SEPARATOR........................................................................................................................................................98
9.8. DÜRR AMALGAM SEPARATOR..............................................................................................................................................................99
9.9. DENTAL CHAIR........................................................................................................................................................................................99
9.10. CATTANI GRAVITY AMALGAM SEPARATOR.........................................................................................................................................99
10. WARNING/ERROR MESSAGES................................................................................................................................................................. 100
11. TECHNICAL DATA...................................................................................................................................................................................... 102
11.1. A3 PLUS CONTINENTAL MODEL DIMENSIONAL CHARACTERISTICS...............................................................................................106
11.2. A3 PLUS INTERNATIONAL MODEL DIMENSIONAL CHARACTERISTICS ...........................................................................................107
11.3. DIMENSIONAL CHARACTERISTICS OF A5 CONTINENTAL MODEL...................................................................................................108
11.4. DIMENSIONAL CHARACTERISTICS OF A5 INTERNATIONAL MODEL................................................................................................109
11.5. DIMENSIONAL CHARACTERISTICS OF A5 CART MODEL..................................................................................................................110
11.6. DIMENSIONAL CHARACTERISTICS OF A5 SINGLE CART MODEL ....................................................................................................111
11.7. DIMENSIONAL CHARACTERISTICS OF A5 SINGLE WATER UNIT MODEL........................................................................................112
11.8. A6 PLUS CONTINENTAL MODEL DIMENSIONAL CHARACTERISTICS...............................................................................................113
11.9. A6 PLUS INTERNATIONAL MODEL DIMENSIONAL CHARACTERISTICS ...........................................................................................114
11.10. DIMENSIONAL CHARACTERISTICS OF L6 CONTINENTAL MODEL..............................................................................................115
11.11. DIMENSIONAL CHARACTERISTICS OF L6 CONTINENTAL MODEL in HYBRID version................................................................116
11.12. DIMENSIONAL CHARACTERISTICS OF L6 INTERNATIONAL MODEL...........................................................................................117
11.13. DIMENSIONAL CHARACTERISTICS OF L6 SIDE DELIVERY MODEL ............................................................................................118
11.14. DIMENSIONAL FEATURES OF SURGICAL SINGLE CART .............................................................................................................119
12. DENTAL UNIT MAINTENANCE SCHEDULE.............................................................................................................................................. 120

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1. GENERAL WARNINGS
•These instructions explain how to correctly use the following dental unit:
A3 PLUS (SN.71IF, 71IG)
A5
A6 PLUS
L6
A3 PLUS CONTINENTAL
(SN.71HU)
A5 CONTINENTAL
(SN.71IA)
A6 PLUS CONTINENTAL
(SN.71HW)
L6 CONTINENTAL
(SN.71H1)
A3 PLUS INTERNATIONAL
(SN.71HV)
A5 INTERNATIONAL
(SN.71IB)
A6 PLUS INTERNATIONAL
(SN.71HX)
L6 INTERNATIONAL
(SN.71H2)
A5 CART
(SN.71IC)
L6 SIDE DELIVERY
(SN.71H3)
A5 SINGLE CART
(SN.71IE)
L6 CONTINENTAL, HYBRID
version (SN.71H4)
A5 IDRICO SINGOLO
(SN.71ID)
SURGICAL SINGLE CART
(SN. 71HS)
Please carefully read this manual before using the device.
•The dental units described in this manual are manufactured by CEFLA s.c. - via Selice Provinciale 23/A - 40026 Imola (BO) Italia, a manufacturer
complying with the European Directive on medical devices.
•These instructions describe all the versions of the dental units with the maximum possible accessories, therefore not all the paragraphs are applicable
to the unit you have purchased.
•The information, technical specifications and illustrations contained in this publication are not binding.
•CEFLA s.c. reserves the right to introduce modifications and technical improvements without having to modify these instructions.
•The manufacturer has a company policy of continual development. Although every effort is made to keep technical documentation up-to-date at all
times, some of the instructions, specifications and figures given in this manual may slightly differ from the purchased product. The manufacturer
reserves the right to make changes without prior notice.
•The original text is in Italian; this is a translation from the original in Italian.
•The manufacturer’s website contains a list of authorised agents of the various countries.
•EU REG. 2016/679 - GDPR INFORMATION: we inform the user that by activating the connection of the devices to the Internet, the device will
automatically direct data to the Easycheck and Di.V.A. web portals. CEFLA s.c. declares that this data collection exclusively concerns telemetry data
on the operation of the devices, that this data collection does not concern and does not involve the processing of personal data. The Easycheck and
Di.V.A. web portals comply with the requirements of ISDP©10003:2020 - Control rules and requirements for the certification of data processing
processes with regard to the assessment of respect for the fundamental rights of natural persons and the free movement of data.
1.1. SYMBOLS
Note the meaning of the following symbols and expressions:
Type of protection against direct and indirect contact:
Class I.
Type of protection against direct and indirect contact:
Type B.
Accessory compliant with the requirements set out by
Regulation
(EU) 2017/745.
(Class I Medical Device).
WARNING!
Failure to observe may result in equipment damage or
injury to the user and/or patient.
Disposal symbol in accordance with Directive
2012/19/EU.
“See the operator’s manual”
It indicates that it is advisable to consult the operator’s
manual
before using the relevant part of the equipment.
WARNING: biological hazard.
It provides information about possible risks of
contamination deriving from contact with fluids, storage of
infected biological waste.
NOTE:
Identifies information that is especially important for the
user and/or the assistant.
Manufacturer.
Protective ground contact.
Equipment date of manufacture.
Alternating current.
Device serial number.
Part that can be sterilized in a steam autoclave up to 135°
C.
ON / OFF button.
Product/equipment identification code.
"Refer to the operator's manual"
It means that for reasons of safety you need to consult
the operator’s manual before using the equipment.
Pushing prohibited.
Off (a part of the unit).
WARNING: foot crushing hazard.

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On (a part of the unit).
WARNING: Class 2 light source according to
Standard IEC 62471:2006.
Equipment On.
WARNING: hand crushing hazard.
Equipment OFF.
Mark of conformity with technical regulations of Ukraine.
C(MET)us Quality Mark (USA and CANADA)
WARNING: tipping hazard.
Equipment compliant with the requirements set out by
Regulation (EU) 2017/745.
(Class IIa Medical Device).
Notified body: IMQ spa.
"Refer to the Technical Manual"
It means that for reasons of safety you need to consult
the Technical Manual before using the equipment.
Medical device.
The operator’s manual is provided in electronic format.
Equipment compliant with the requirements set out by
Chinese Directive GB/T 26572-2011.
Model Number
1.2. INTENDED USE
The device is a dental unit consisting of components and/or devices that are functionally connected, such as the patient chair, dental unit, dental
handpieces, multifunction pedal and operating light.
The dental unit is intended for professional dental treatment, for example to treat oral and dental pathologies of varying degrees of clinical form, stage,
gravity; and to manage and provide support for dental and oral diagnosis, treatments, post-operative controls for oral health, prevention and prophylaxis.
The prevailing medical conditions to be treated with the dental unit belong to the following branches of dentistry and oral health:
•Oral Hygiene;
•Orthodontics;
•Conservative dentistry and Prosthesis;
•Periodontology;
•Endodontics;
•Implants;
•Oral Surgery.
In order to achieve its intended use, the dental unit may support and control the following parts or devices, if supplied:
•Air/water syringe;
•Turbine;
•Micromotor;
•Scaler;
•Ultrasonic surgical equipment;
•Curing Light;
•Intraoral camera;
•Intraoral X-ray sensor;
•Operating Light;
•Suction system;
•Multimedia systems.
The dental chair is designed to support and position the patient during dental treatment.
Device performance features.
Dental units consist of a dental chair that must support the patient in a comfortable position to facilitate the dentist’s work, and the water unit that must
provide the supply (electricity, compressed air, water) necessary for the operation of the instruments used in the dental practice.
Intended user.
The device must only be used by appropriately trained authorised personnel (professional dentists and dental hygienists, possibly assisted by a properly
trained assistant and under the supervision of the dentist). Routine maintenance of the device may be carried out by the assistant.
Patient population.
The use of the device is intended on the whole patient population for which analyses are usually carried out, according to intended use, instructions for
use, medical practice and local regulations.
Use the device only with vigilant and cooperative patients, since the patient must be able to understand and follow the operator's instructions for a
correct dental treatment.
It is possible to treat patients with disabilities, provided that their disability does not affect their ability to cooperate with the operator.
The device must be used on a population of patients fulfilling the following characteristics:

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Age: approximately 4 years and older, according to the physical characteristics described below (height and weight)
Height: from 1 m.
Weight: see "Maximum permissible load on the dental chair" in the DATA SPECIFICATIONS paragraph.
State of health: good general health (physical impairments are allowed provided that the disability does not affect the patient’s ability to cooperate with
the operator).
Nationality: irrelevant.
State of patient: awake and able to cooperate with the operator.
Pregnancy: there are no special indications for pregnant women, the same indications as above apply.
Contraindications
The device is not intended for the following uses and/or applications:
•Use on unintended anatomical areas;
•Use on patients weighing more than the maximum permitted load;
•Use on non-alert or uncooperative patients or patients unable to maintain their position for the duration of the operation;
•Use by an unauthorised dental practitioner;
•Use by an operator not trained on the device.
Characteristics of the dental unit
•The dental units described in this manual are Medical Devices intended for dental treatment.
•The dentist's board may hold up to 6 instruments.
•The assistant’s board can hold 2 suction tubes and 3 instruments.
•This equipment must be used only by adequately trained personnel (dentists and paramedics).
•The device is intended for non-continuous operation with intermittent loads (see the operating times of the individual parts in the dedicated sections).
•The device is classified as pollution degree 2 (under IEC 60601-1).
•Overvoltage category (under IEC 60664-1): II.
(for American and Canadian markets only):
Dental units and relevant accessories are intended for dental treatment and provide the dentist with a user interface allowing to
control the operation of dental chair and all connected instruments. The system supplies air, water, a suction system and electricity
to allow the dentist to intuitively control all the procedures for patient care normally performed in a dental surgery.
Federal law restricts the sale of this equipment to dentists only.
1.2.1. CLASSIFICATION AND REFERENCE STANDARDS
•Classification of MEDICAL DEVICES:
Dental unit classification according to the rules set out in Annex VIII of Reg. (EU) 2017/745: Class IIa.
The CE mark certifies the conformity of the product with the Medical Device Regulation (EU) 2017/745, as described here.
•Classification of ELECTRICAL MEDICAL EQUIPMENT:
Classification of the dental unit in accordance with standard EN 60601-1 on safety of medical equipment: Class I - Type B.
•Reference standards:
the dental units described in this manual are equipment designed in compliance with IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) (Ed.3),
IEC 60601-1:2005 + A1:2012 (Ed. 3.1), IEC 60601-1-6:2010 (Ed.3), IEC 62366:2007 (Ed.1), IEC 80601-2-60:2019 (Ed.2), IEC 60601-1-2:2014 (Ed.4),
IEC 62304:2006 + A1:2015 (Ed.1.1), ISO 6875:2011 (Ed.3), ISO 7494-1:2011 (Ed.2) and EN 1717:2000 (Ed.1) standards on devices for the safety of
the water system (protection unit type AA and AB).

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1.2.2. ENVIRONMENTAL CONDITIONS
The equipment is to be installed in rooms that satisfy the following requirements:
•temperature between 10 and 40°C;
•relative humidity between 30 and 75%;
•atmospheric pressure ranging from 700 to 1060 hPa;
•altitude ≤ 3000 m;
•air pressure entering equipment ranging from 6 to 8 bar;
•water hardness at the equipment inlet must not be above 25 °f (French degrees) or 14 °d (German degrees) for untreated drinking water. For water
with a higher hardness degree, it is recommended to soften water until it reaches a hardness degree between 15 and 25 °f (French degrees) or
between 8.4 and 14 °d (German degrees);
•water pressure entering equipment ranging from 3 to 5 bar;
•water temperature entering equipment not higher than 25°C.
•water conductivity at 20°C: < 2000 μS/cm.
•recommended water acidity: 6.5-8.5 pH (ISO 7494-2-2015);
•the electric system in the room in which the equipment is installed must conform to IEC 60364-7-710 (standards for electric systems in medical and
dental offices).
•floor condition: continuous type with a dowel breaking strength of not less than 260 daN each (installation with the aid of the load distribution plate) or
1200 daN each (installation without the aid of the load distribution plate).
1.2.2.1. STORAGE CONDITIONS
•Temperature between -10 and 70°C;
•Relative humidity between 10 and 90%;
•Atmospheric pressure: from 500 to 1060hPa.
1.2.3. WARRANTY
CEFLA s.c. stands behind its products warranting safety, reliability and performance.
The warranty is effective from the date of installation of the product.
The product is covered for the warranty period indicated in the Installation Report and, in any case, not less than 12 months.
The warranty is valid only under the following terms:
•Conditions given on the warranty certificate are observed.
•Yearly scheduled maintenance is performed.
•The equipment is used only as instructed in this manual.
•The equipment must be installed in an environment that complies with the requirements of the ENVIRONMENTAL CONDITIONS section.
•A 3x1.5 mm2line protected by a bi-polar cut-out that conforms to applicable standards (10 A 250 V or 15 A 120 V distance between contacts at least 3
mm) must be used to feed the equipment.
The colour of the three wires (POWER, NEUTRAL and EARTH) should satisfy the requirements of current standards.
•Installation, repairs, equipment enlargement, settings and, in general, any other operation requiring the casing to be opened are to be performed
exclusively by personnel authorised by CEFLA s.c..
1.2.4. DISPOSING THE EQUIPMENT WHEN NO LONGER USED
In compliance with Directives 2011/65/EU and 2012/19/EU regarding restriction of the use of certain hazardous substances in electrical and electronic
equipment along with waste electrical and electronic equipment, it is forbidden to dispose of this equipment in the municipal waste stream as unsorted
municipal waste.
When purchasing a new device of an equivalent type, one for one, the device that has come to the end of its lifetime should be returned to the dealer for
disposal. As regards reuse, recycling and other forms of recovery of waste electrical and electronic equipment, the Manufacturer carries out the
functions defined by current local laws. Appropriate differentiated waste collection for subsequent recycling treatment and environmentally friendly
disposal contributes to preventing possible negative effects on the environment and health and encourages recycling of the materials of which the
device is made up. The symbol indicating separate collection for electrical and electronic equipment consists of the crossed out bin marked on the
equipment.
Under local legislation, fines can be imposed if the equipment is disposed in an illegal manner.

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1.3. SAFETY WARNINGS
•All equipment is permanently installed.
Depending on the type of dental chair the dental unit comes with, refer to the installation SCHEMATICS in paragraph DATA
SPECIFICATIONS
The CEFLA s.c. shall not be held liable for any personal injury or property damage arising from failure to heed the following clause.
•Floor conditions.
The floor (continuous) should meet the load-bearing capacity set forth by DIN 1055, sheet 3.
The weight of the dental unit including a patient is about 400 kg.
For further details on anchoring conditions, refer to the Installation Manual.
The positions of delivery and drain line connections comply with standard ISO 7494-2.
In case of floor installation without load distribution plate, floor characteristics must ensure a breaking strength of the anchor bolt not less than
1200 daN each (considering RcK concrete strength 20 MPa). In case of floor installation with load reduction plate, floor characteristics must
ensure a strength of the anchor bolt not less than 260 daN.
•This device may not be modified in any way without the authorisation of the manufacturer.
If the device is modified, appropriate examinations and tests need to be conducted in order to ensure continued safe use.
The CEFLA s.c. shall not be held liable for any personal injury or property damage arising from failure to heed the following clause.
•Dental chair.
The maximum load values indicated in the DATA SPECIFICATIONS paragraph must never be exceeded.
•Tray holders.
The maximum weights that can be held must never be exceeded:
- tray holder attached to the dentist's board, maximum permitted load on the tray holder module 2 kg, evenly distributed.
- Tray holder attached to the assistant's board, maximum permitted load 1 Kg, evenly distributed.
- Auxiliary tray holder, maximum permitted load on the tray 3.5 Kg (without negatoscope) or 2.5 Kg (with negatoscope).
•Connections to external instruments.
The equipment can be electrically connected only to other instruments that bear the CE mark.
•Electromagnetic interferences.
Use of electrical equipment that does not comply with standard IEC 60601-1-2 in the surgery or nearby may cause electromagnetic or other
types of interferences resulting in dental unit malfunctions.
In these cases, it is recommended to shut off power to the dental unit before using this equipment.
•Replacing the drills.
Operate the turbine release and contra angle devices only once the drill has come to a complete stop. Failure to do so will result in damaging
the locking system and drills could be released and cause injury. Exclusively use high-quality drills with a connection rod having a calibrated
diameter. To check the conditions of the locking system, make sure the drill is firmly secured to the instrument every day before starting work.
Locking system defects caused by misuse can be easily identified and are not covered by the warranty.
The drills and various instruments attached to the handpieces must comply with Biocompatibility Standard ISO 10993.
•Patients with active implantable medical devices.
When treating patients with implanted active devices, such as cardio-stimulators, hearing aids or other active devices, the possible effects of
the instruments used on the implanted device should be considered. Please refer to the technical-scientific literature available on this subject
and to the instructions for use of said devices.
•Use with external instruments.
If the dental unit is used for operations using separate standalone equipment such as mobile equipment for implants or endodontics, you are
recommended to power off the dental chair to avoid unwanted movements resulting from accidental start up of the movement controls.
•Do not forget to turn off the office water supply and main switch on the equipment before leaving the surgery.
•The equipment is not protected against liquid penetration IP X0.
•The equipment is not suitable for use in the presence of a mixture of flammable anaesthetic gas with oxygen or nitrous oxide.
•This equipment must be stored properly so that it is kept in top working order at all times. The manufacturer shall not be held
responsible (under civil and criminal law) for misuse, carelessness or improper use of the equipment.
•The equipment may only be used by authorised and adequately trained staff (physicians and paramedics).
•The user must be present at all times when the equipment is turned on or ready for start-up. In particular, never leave the
equipment unattended in the presence of children/the mentally disabled or other unauthorised personnel in general.
Any accompanying person must stay outside the area in which the treatment is performed and in any case on responsibility of the operator.
The operating area refers to the space around the dental unit plus 1.5 meters.
•Quality of the water delivered by the dental unit.
The user is responsible for the quality of the water delivered by the dental unit and must adopt measures to maintain the water quality.
To ensure that delivered water is kept to quality standards, CEFLA s.c. recommends equipping the dental unit with an internal or external
disinfection system.
The dental unit, once installed, is exposed to possible contaminants coming from the water mains. So, to effectively overcome this problem, it
is recommended to install and operate the dental unit only at the moment in which the professional will use it daily and perform the
disinfecting procedures starting from the day in which it is installed by following the instructions set forth in the relevant sections.
If the dental unit is equipped with the air separation device from water mains (EN 1717), make sure that the expected continuous supply of
disinfectant is also carried out by ensuring that the relevant tank contains a suitable quantity of disinfectant (see relevant paragraph).
Contact your local dealer or Association of Dentists for more detailed information about national laws and requirements.
•Applied parts.
The parts of the equipment that, during standard use, necessarily come into contact with the patient, so that the device may carry out its
functions correctly, are: dental chair upholstery, armrest support, syringe end part. During normal use, the patient may also come into contact
with the following parts of devices used in combination with the dental unit: fibre optic of the curing light, camera disposable infection control
sheath, scaler tips, handpiece drills, suction tube holder terminals.
Non applied parts that may come into contact with the patient are: dental chair armrest support, dental chair lower casing, patient-side water
unit casing, water-to cup-spout, bowl, suction tubes, handpiece body.
•Dental chair movement.
Make sure that the patient is ready to collaborate: ask him/her to keep his/her hands and feet close, avoiding incorrect postures.
Check that the patient is sitting properly when moving the chair (see figure).

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•For operators in Europe: any serious accident occurred in relation to the device must be reported to CEFLA s.c. and to the
competent authority of the Member State where the user and/or patient lives.
1.4. ELECTROMAGNETIC SAFETY
Electromagnetic immunity.
The device is intended for use in environments recognised as professional health facilities, as described in IEC 60601-1-2:2014. The device belongs to
CISPR 11 Class A Group 1 and complies with immunity test levels specified by IEC 60601-1-2:2014 for professional health facilities.
Before using any electronic device in health facilities, always check that it is compatible with the other equipment present.
If it is used in a residential environment (as specified in CISPR 11 class B) this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
For further information on immunity levels and characteristics of the electromagnetic environment, see the specific tables in paragraph TECHNICAL
SPECIFICATIONS.
•Use of this equipment adjacent to or stacked with other equipment should be avoided, because it could result in improper
operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating
normally.
•Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could
result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper
operation.
•Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the device, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
•Do not subject the device to strong electromagnetic disturbances.
Electrical medical equipment are subject to special precautionary measures in relation to electromagnetic compatibility (EMC). The
equipment must be installed and used according to the Manufacturer’s instructions. Failure to observe the installation
requirements and the Manufacturer’s instructions could affect the equipment position and the correspondence of its operating
parameters.

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1.5. CLEANING AND DISINFECTION
Cleaning is the first step required for any disinfection process.
Physically scrubbing with detergents and surface-active substances and rinsing with water removes a considerable amount of micro-organisms. If the
surface is not first cleaned, the disinfection process cannot be successful.
If a surface cannot be adequately cleaned, it should be protected with barriers.
The outer parts of the equipment must be cleaned and disinfected using a product for hospital use with indications for HIV, HBV and tuberculocidal
(medium-level disinfectant) specific for small surfaces.
The various drugs and chemical products used in dental surgeries may damage the painted surfaces and the plastic parts. Researches and tests
performed show that the surfaces cannot be fully protected against the harsh action of all products available on the market. We therefore recommend
protecting with barriers whenever possible.
The harsh actions of chemical products also depend on the amount of time they are left on the surfaces.
It is therefore important not to leave the product on the surfaces longer than the time specified by the manufacturer.
It is recommended to use the specific medium-level disinfectant, STER 1 PLUS (CEFLA s.c.), which is compatible with:
•Coated surfaces and plastic parts.
•Upholstery.
The MEMORY FOAM upholstery will stain when splashed with mordant acid. Immediately rinse with plenty of water if acid spatters
on the upholstery.
•Uncoated metal surfaces.
STER 1 PLUS must be used as specified by the Manufacturer.
If you do not use STER 1 PLUS, it is recommended to use products that contain at maximum:
•Ethanol. Concentration: maximum 30 g per 100 g of disinfectant.
•1-Propanol (n-propanol, propyl alcohol, n-propyl alcohol). Concentration: maximum 20 g per 100 g of disinfectant.
•Combination of ethanol and propanol. Concentration: the combination of the two should be maximum 40 g per 100 g of disinfectant.
•Do not use products containing isopropyl alcohol (2-propanol, iso-propanol).
•Do not use products containing sodium hypochlorite (bleach).
•Do not use cleaners containing phenols.
•Do not spray the selected product directly on the surfaces.
•All products must be used as directed by the manufacturer.
•Do not mix the STER 1 PLUS disinfectant with other products.
The products suggested are compatible with the materials of the equipment, however damages may occur to surfaces and
materials resulting from the use of different products, even if not included in the above list of excluded products.
Cleaning and disinfecting instructions.
Clean and disinfect with disposable non-abrasive paper (avoid using recycled paper) or sterile gauze.
Do not use sponges or, in any case, any material that can be reused.
•It is recommended to turn off the dental unit prior to cleaning and disinfecting the external parts.
•All materials used for cleaning and disinfection must be thrown away upon completing the procedure.
The cleaning/disinfection/sterilization times of each element of the dental unit are listed in the booklet "PROTOCOL FOR HYGIENIC
MAINTENANCE OF THE DENTAL UNIT", also supplied with the unit.