Castellini Puma Eli Series Manual

"Puma Eli" UNIT; INSTRUCTIONS USE AND MAINTENANCE HANDBOOK
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CASTELLINI S.p.A.
Via Saliceto, 22
40013 CASTEL MAGGIORE
BOLOGNA (ITALY)
Tel (int. code) + 051700877
Fax (int. code) + 051701056
E mail: [email protected]
INSTRUCTIONS USE AND MAINTENANCE HANDBOOK
INSTRUCTIONS FOR THE INSTALLATION
Puma Eli
family
Medical Device for Dentistry
390 . 2E . L06
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Summary
Part I - Instructions use and maintenance handbook...............................................................................3
Important notice............................................................................................................................................... 4
Setting-up procedures ....................................................................................................................................... 5
Maintenance and revisions................................................................................................................................. 7
Informations about conformity by “Puma Eli” dental equipment at CEI EN 60601-1-2 Norms - 2001 Edition ........... 8
Technical data equipment.................................................................................................................................10
Unit identification label.....................................................................................................................................11
Medical devices applies to the unit - Unit operation ............................................................................................13
Pictures and descriptions ..................................................................................................................................14
Foot control functions.......................................................................................................................................20
Chair movements.............................................................................................................................................21
Autosteril/Time Flushing System .......................................................................................................................23
Separate supply system....................................................................................................................................25
Suction systems
(optional) ................................................................................................................................26
Conversion of the “Puma Eli" unit from right-handed to left-handed configuration
(only for ambidextrous dental units) ..................................................................................................................27
Disinfection and sterilization .............................................................................................................................28
Equipment sanitization schedule .......................................................................................................................30
Routine maintenance .......................................................................................................................................31
Routine maintenance program ..........................................................................................................................34
Products to be used with the Castellini dental unit .............................................................................................35
Part II – Operating lamp “Luna”..............................................................................................................36
Technical data .................................................................................................................................................37
Pictures and descriptions - Replacement of the bulb...........................................................................................38
Focusing of the “Luna” operating light - Pantograph arm regulation ....................................................................39
Overall dimensions...........................................................................................................................................40
Part IV – Operating instruments .............................................................................................................41
“Threesteril” Syringe ........................................................................................................................................42
“Cleanair 2000” - “Cleanlight 2000” Turbine.......................................................................................................44
"Hi–Power 2 Ceramic" – "Titanium Gold 2" - "Titanium Gold 2 Miniature" Turbine................................................48
“Implantor 2” Micromotor .................................................................................................................................52
"Air Power 2" Air micromotor ............................................................................................................................55
"Piezosteril 5" Scaler handpiece ........................................................................................................................57
"Leda" Polymerizing lamp .................................................................................................................................59
Part V – Instructions for the installation................................................................................................. 61
Essential requirements .....................................................................................................................................62
Permitted environmental conditions for transport and storage ............................................................................63
Installing the chair and the unit ........................................................................................................................64
Installing the right-hand unit ............................................................................................................................67
Installing the dental unit
(only ambidextrous units) ............................................................................................68
Safety covers...................................................................................................................................................78
Replacing the lamp of the negatoscope for intraoral X-rays ................................................................................81
Adjusting the tension of the levers on the instrument tray model S.P.R.I............................................................82
Adjusting the working pressures .......................................................................................................................83
Overall dimensions...........................................................................................................................................84
Unit hydraulic systems .....................................................................................................................................87
Unit electricic systems ......................................................................................................................................90
Part VI – Scheduled maintenance program – Servicing - Warranty conditions ......................................92
Scheduled maintenance and servicing ...............................................................................................................93
Servicing .........................................................................................................................................................94
Warranty conditions .........................................................................................................................................95
Forms for periodic checks (1 ÷ 10 Years) ..........................................................................................................96
Appendix I – Certifications
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Puma Eli
PART I - INSTRUCTIONS USE AND
MAINTENANCE HANDBOOK
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"Puma Eli" UNIT; INSTRUCTIONS USE AND MAINTENANCE HANDBOOK
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IMPORTANT NOTICE
This unit is a medical device for dental treatment conforming to EEC Directive 93/42 - MEDICAL DEVICES - (see enclosed
certification of compliance) and with CEI EN 60601-1 standard (General standard for the safety of electromedical
equipment).
It is intended to be used by dentists only, who may avail themselves of the assistance of authorized personnel.
We prescribe to read the instructions contained in the users’ manual carefully before using the unit.
Furthermore, before using any of the devices connected to the dental unit, we prescribe to read the instructions
attached to each single device carefully.
The instructions for installing the device and the instructions for technical service and repair are held by the “CASTELLINI
AUTHORISED” TECHNICIAN IN POSSESSION OF A VALID LICENCE.
The Manufacturer will not be held responsible for the safety, reliability, or performance of the equipment in
the event of civil or penal proceedings if:
a) the essential environmental requirements as stated in the “Table on Compliance of Installations, Premises and Supply”
are not met;
b) assembly, additions, adjustments, re-settings, repairs are not performed by “AUTHORISED CASTELLINI
TECHNICIANS” IN POSSESSION OF A VALID CASTELLINI IDENTIFICATION CARD;
c) any medical devices other than those authorised by Castellini itself or devices that fail to meet the compatibility
parameters specified by Castellini S.p.A. are connected to Castellini equipment;
d) unauthorised modification, arbitrary tamperings, incorrect maintenance operations are carried out or if non-original
spare parts and/or components are used;
e) the equipment is not used in compliance with the instructions for use (as set out in the use and maintenance manual)
or if it is used for purposes other than those for which it is designed;
f) the power, water and compressed air supply, the water drainage system and the air extraction system (where
applicable) do not comply with the conditions stated in the use and maintenance manual (see “preparing for installation”
paragraph and equipment installations plan, scale 1:1 code F2210587
(for ambidextrous version ) and code F2210B588
(for right-hand version) and comply with the country legal provisions;
g) scheduled technical maintenance is not performed at the times indicated;
h) the user does not undertake all routine maintenance work and does not comply with the directions and rules in this use
and maintenance manual.
Failure to comply with the above conditions automatically voids the guarantee terms, and can endanger the safety
requirements defined under 93/42 EEC Norm, transferring full responsibility for safety and EEC mark compliance for the
product on to those responsible for carrying out the operations described above.
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DENTAL CARE SETTING: rules and recommendations
Besides complying with the requisites provided by local laws for health care facilities, the room should:
- be at least 2.50 m in length (optimal: 3.30 m) on its shorter side;
- have washable flooring capable of withstanding shocks and chemical agents, e.g. porcelain stoneware, with no gaps
between the tiles and, if possible the surface where the walls and floor meet should be rounded to facilitate cleaning:
- have walls covered up to h. 2.00 m with washable materials resistant to chemical agents;
- have lighting provided by two ceiling fixtures with a double fluorescent tube, daytime light 5500°K, covered by alveolar
grids, arranged longitudinally over the chair, so that the long sides are parallel;
- be free of non-sanitary curtains, upholstery, furniture and furnishing complements, ornamental plants.
Before installing the dental unit: the principal of the Surgery must verify that the plumbing for water supply and drainage,
air supply lines, centralised suction lines (where applicable) and electrical system all meet requirements. He/she must
provide for any necessary work to be done, following the instructions shown on the installation layout on a scale of 1:1
code F2210587
(for ambidextrous model) , code F2210B588 (for right-hand model) , which is supplied on request prior to
installation, and the guidelines provided in the table "Conformity of Equipment, Environment and Supply Systems".
SETTING-UP PROCEDURES
Once the equipment is installed, the following operations must be performed before it may be used:
- Sterilization of instruments (see part “Operating Instruments”).
- Sterilization or disinfection of all sterilizable parts supplied non-sterilized and disinfection of upholstery and any parts
normally coming into contact with patients (see par. on cleaning, disinfection and sterilization).
- Performance of a spray pipes disinfecting cycle with a contact time (TC) of 10 mins (see Autosteril and
Time-Flushing paragraph). (see section on Autosteril and Time-Flushing).
- Application of disposable protections where required.
- Check that the burrs and tips are securely fitted into the instruments (see part “Operating Instruments”).
USING SAFELY: rules and recommendations
To ensure that the equipment is used safely, the user must abide by the set standards of hygiene and professional
diligence.
The following points should also be kept in mind:
- during use: dust and fragments of material from the patient’s mouth or the device being used may be thrust into the
surrounding environment (organic and inorganic particles, metal dust, liquids, potentially infected fluids
and biological materials):
Personnel must duly protect their eyes, breathing passages, mouth and skin
by wearing safety glasses, face shields, masks and disposable gloves.
Operate the suction system at high speed in all operations likely to result in a discharge of materials, dust and aerosols to
minimise their dissemination.
- During use, materials and microorganisms coming from a patient may penetrate into the waterlines and be expelled into
the next patient and into the environment. The passive systems of protection installed in this equipment (No-retraction
system, Barrier Effect, etc.) minimise the risk but cannot eliminate it completely:
We recommend performing a spray pipes disinfecting cycle with a contact time (TC) of 10 min at the start
of each working day and after use on each patient.
- the instruments have exposed tips and sharp parts (burrs and other rotating instrument attachments, scaler tips etc.):
take care to avoid accidental cuts and punctures;
-
after use: Remove the aforesaid parts from the instruments;
Do not leave sharp and/or pointed parts mounted on the equipment when it is left unattended;
It is mandatory to sterilize the cord-attached instruments or their removable invasive parts,after washing
and disinfecting the surfaces (see specific instructions). Sterilization must take place in a steam autoclave at 135°C, 2.1
bars (sterilization requisites also prescribed by Italian Law, Health Minister’s Decree of 28.09.1990, art. 4);
It is mandatory to regularly carry out the sanitization procedures described in this manual in the paragraph on
“cleaning, disinfection, sterilization”;
- it is not advisable to use drinking water to supply the dental unit since it may lead to the formation of a biofilm in the
waterlines and thus facilitate germ proliferation inside the unit itself.
It is recommended to supply the unit exclusively with dedicated liquids (Isotonic Saline Solution or It.Ph. Purified
Water) using the Separate Supply system.
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The Principal of the Dental Surgery is responsible for ensuring that the equipment, environment and water
supply comply with the basic requisites shown in the table below:
TABLE OF CONFORMITY OF EQUIPMENT,
Environment, Water Supply
ITEM ESSENTIAL REQUIREMENTS
Premises a) protected from risk of explosion, non pressurized
b) temperature between 10 °C and 40 °C
c) Relative humidity between 30 % and 75 %
d) Air pressure between 700 hPa and 1060 hPa (700 ÷1060 mbar)
Electrical installation a) compliance with regulations concerning electrical installations in premises used for medical
purposes. All power and water supply installations must comply with the country legal provisions.
b) Single-phase mains current, 230 V ± 10% - 50/60 Hz ± 10 % frequency
Electrical power supply Adequate for power requirements, as specified on the appliance’s rating information plate
Single-phase power 230 V - 50/60 Hz
Maximum allowed variation on electrical power supply: ± 10 %.
Max absorbed power 1,45 kVA
The unit is fitted with a terminal board for connection to a permanent power supply system.
Upstream from the unit have to be installed a differential, bipolar switch for at least 16 A - 250 V
with differential operating time current I∆N = 0,03 A
The electrical wiring of the room and the heart connection must comply with the current
regulations.
The addition of an air-compressor will require a power supply and safety fuse that must be
independent from the unit.
Water supply Compliance with the country’s legal provisions on drinking water
Water treatment plant Compliance with the country’s legal provisions on drinking water
Water supply Drinking water for domestic use, duly filtered and decalcified, for mouth rinse cup and cuspidor
a) hardness: 15 -20 °F (French degrees)
b) pressure: 300 -500 kPa (3 -5 bars)
c) flow: ≥3 l/min at 450 kPa (4.5 bars)
Should the pressure be lower than 300 kPa (3 bars), install a device upstream from the dental unit
to ensure the necessary pressure (autoclave).
Should the pressure exceed 500 kPa (5 bars), install a suitable pressure-reducing device upstream
from the dental unit.
The water supply line must be fitted with an isolating valve.
N.B.: To avoid the risk of contaminating the water supply as a result of the possible backflow of
liquid from the dental unit, after irrigating tips have come into contact with the patient or chemical
agents, instruments may be supplied using ONLY one of the following systems:
1 - Solely with liquid contained in the separate tank installed in the dental unit; the separate supply
system option must always be selected (see section on "Separate supply system” in the user
instructions).
2 - With mains water, after a dental water supply system conforming to standard CEI EN 1717 has
been installed upstream from the dental unit to guarantee the physical separation of mains water
and instrument sprays (e.g. "WEK" Metasys or equivalent).
Before the mounting of the unit: WE PRESCRIBE TO clean thoroughly all pipes to prevent
impurities from fouling the unit’s water/air circuits, and to bleed extensively the water supply pipe
so that no air bubbles remain in the system.
Compressed air plant The compressor must be installed in a well ventilated room and not in close proximity of heat
sources or exhaust air from the vacuum system.
Compressed air supply a) Compressed air pressure between 550 kPa and 700 kPa (5,5 ÷ 7 bar)
b) Capacity in excess of or equal to 50 1/min at 400 kPa (4 bar)
c) Dew point: less or equal to 10 °C
The compressor air supply line must be fitted with an isolating valve.
Vacuum system The pipework system must be installed if you intend connecting the unit to a centralized suction
system.
For a single dental unit it is sufficient to connect the aspirator to the unit through the appropriate
tube supplied.
The vacuum suction system must discharge the exhaust air outside to atmosphere.
Air flow rate 300 l/min.
Vacuum value 10 kPa (0,1 bar)
Waste water line We recommend a waste line slope of 1 cm for each metre of distance from the unit to the main
waste. A “p” trap must be installed on the drain line outside the unit.
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MAINTENANCE AND REVISIONS
The dental patient chair, dental unit (including all the tools and devices connected to it, with the exception of high speed
drills), operating lamp, x-ray equipment, compressor and any other device manufactured by Castellini S.p.A. that forms an
independent unit must undergo the scheduled annual maintenance operations (except where otherwise indicated in the
part on “Scheduled Maintenance Operations” in this Manual) by technicians carrying a valid Castellini identification card,
365 days after installation, regardless of whether they have actually been used or not.
High speed drills manufactured by Castellini S.p.A. must undergo the scheduled annual maintenance operations performed
by qualified technicians authorised by Castellini (except where otherwise stated in the part on “Scheduled Maintenance
Operations” in this Manual).
The owner of the equipment is responsible for booking the services of the Castellini technician at all times.
The high speed drill must be returned to Castellini S.p.A. three years after installation to be reconditioned at the
manufacturing plant.
Subsequently, high speed drills should be reconditioned every three years, in addition to undergoing the above described
scheduled annual maintenance operations.
CIRCUIT DIAGRAM, LISTS OF COMPONENTS, CALIBRATION INSTRUCTIONS
Castellini S.p.A. undertakes to provide on request circuit diagrams, lists of components, calibration instructions or any
other information that may be required by qualified technicians authorized by Castellini and in possession of a valid
professional licence to repair those parts of the equipment that may be repaired.
Castellini S.p.A. reserves the right to modify the products at any moment without notice.
ATTENTION
- This unit complies with the EMC 89/336 EC Directive, according with the CEI EN 60601-1-2 Standard.
During the working, this unit will not cause radio interference to the electric network.
(*) See chapter: “INFORMATIONS ABOUT CONFORMITY BY “Puma Eli” DENTAL EQUIPMENT AT EEC CEI EN
60601-1-2 NORMS - 2001 EDITION”.
SCRAPPING
If scrapped, the equipment must be disposed of in accordance with the provisions of applicable legislation.
The materials used to construct the equipment do not constitute a hazard for humans or animals in the event of contact or
exposure.
For disposal of the amalgam separator (if present), strictly follow the instructions and warnings given in the section
“ACCESS TO AMALGAM SEPARATOR”.
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INFORMATIONS ABOUT CONFORMITY BY “Puma Eli” DENTAL EQUIPMENT AT CEI EN 60601-1-2 NORMS - 2001 EDITION
Annex A
The “Puma Eli” unit is suitable for use in the specified electromagnetic enviroment. The purchaser or user of the
“Puma Eli” unit should assure that it is used in an electromagnetic enviroment as described below:
Emission test Compliance Electromagnetic Enviroment
Radiated and conducted
RF emission
Class B The “Puma Eli” unit is suitable for use in domestic
establishments directly connected to the low voltage power
supply network which supplies buildings used for domestic
purposes
CISPR 11 Group 1 The “Puma Eli” unit uses RF energy only for its internal
function. Therefore, the RF emission is very low and not likely
to cause any interference in nearby electronic equipment.
Harmonic emissions Complies The “Puma Eli” unit is suitable for use in establishments
directly connected to a public low voltage power supply
network.
Voltage fluctuations/
flicker emissions
CEI EN 61000-3-3
Complies The “Puma Eli” unit is suitable for use in establishments
directly connected to a public low voltage power supply
network.
Annex B
The “Puma Eli” unit is suitable for use in the specified electromagnetic enviroment. The purchaser or user of the
“Puma Eli” unit should assure that it is used in an electromagnetic enviroment as described below:
Immunity
Test
CEI EN 60601-1-2
Test level
Compliance
level
Electromagnetic Enviroment
Electrostatic
discharge (ESD)
CEI EN 61000-4-2
6 kV contact
8kV air
CEI EN 60601-2
Test level
Residential
Radiated RF
CEI EN 61000-4-3
Conducted Rf
CEI EN 61000-4-6
Non-life-supporting
Equipment
3 V/m
80 MHz to 2,5 GHz
Life-supporting
equipment
10 V/m
80 MHz to 2,5 GHz
Non-life-supporting
equipment
3 V
150 kHz to 80 Mhz
Life-supporting
equipment
3 V (outside ISM band)
10 V (inside ISM band)
CEI EN 60601-1-2
Test level
CEI EN 60601-1-2
Test level
CEI EN 60601-1-2
Test level
Residential
Electrical fast
transient/burst
CEI EN 61000-4-4
2 kV for power
supply lines
1 kV for input/output
lines > 3 m
CEI EN 60601-1-2
Test level
Residential
Surge
CEI EN 61000-4-5
1 kV differential mode
2 kV common mode
CEI EN 60601-1-2
Test level
Residential
(see next →)
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Voltage dips, short
in terruptions
and voltage
variations on power
supply input lines
CEI EN 61000-4-11
0% Un for 0,5 cycles
40% Unfor 5 cycles
70% Unfor 25 cycles
0% Un for 5 s
CEI EN 60601-1-2
Test level
Residential
Power frequency
(50/60 Hz)
magnetic field
CEI EN 61000-4-8
3 A/m CEI EN 60601-1-2
Test level
Residential
Annex C
Recommended Separation Distance for non-LIFE SUPPORTING EQUIPMENT
RF Source Typical Rated Power
(W)
Distance
(m)
microcellular phone CT1, CT2, CT3 0,01 0,4
DECT cellular phone, wireless information
technology
equipment (modems, LANs)
0,25 2
cellular phone, hand-held (USA) 0,6 3
cellular phone, hand-held (e.g. GSM and NMT,
EUROPE;
DECS 1800)
2
8
6
11
walkie-talkie (rescue, police, fire, maintenance) 5 9
cellular phone, bag 16 16
mobile radio (rescue, police, fire) 100 40
For transmitter using frequencies below 800 MHz, the DISTANCE can be estimated using Equation A:
Pd 4=
For transmitters using frequencies between 800 MHz and 2 GHz, the DISTANCE can be estimated using Equation B:
Pd 3.2=
where P is the rated power of the trasmitter in watt (W) according to the transmitter manufacturer.
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TECHNICAL DATA EQUIPMENT
UNIT
MEDICAL DEVICE CLASS IIa By 93/42 EEC DIRECTIVE
ELECTRO MEDICAL EQUIPMENT CLASS I - TYPE B By CEI EN 60601-1 Standard
THE EQUIPMENT CANNOT BE USED WHEN FLAMMABLE ANESTHETIC MIXTURES CONTAINING AIR OR
OXIGEN OR NITROUS OXIDE ARE PRESENT
DEGREE OF PROTECTION AGAINST WATER INFILTRATION: IPX0
POWER SUPPLY
MAXIMUM POWER INPUT (Unit+chair+suction system working together) 1450 VA
MAINS VOLTAGE 230 V~
SINGLE-PHASE A.C AT 50 Hz
INTERMITTENT OPERATION (Refer to the use specifications)
WATER SUPPLY (See note in "TABLE OF EQUIPMENT CONFORMITY) DRINKING WATER
PRESSURE 300 ÷ 500 kPa (3 ÷ 5 bar)
MAXIMUM CONSUMPTION 3 l/min at 450 kPa (4.5 bar)
Should the pressure be lower than 300 kPa (3 bars), install a device upstream from the dental unit to ensure the necessary
pressure (autoclave).
Should the pressure exceed 500 kPa (5 bars), install a suitable pressure-reducing device upstream from the dental unit.
The water inlet MUST BE fitted with a cut-off valve.
AIR SUPPLY
PRESSURE 550 ÷ 700 kPa (5,5 ÷ 7 bar)
CONSUMPTION 50 l/min at 400 kPa (4 bar)
VACUUM
AIR FLOW RATE ≥300 l/min
VACUUM VALUE ≤10 kPa (0.1 bar)
UNIT 70 kg
UNIT + MOTOR CHAIR WEIGHT 205 kg
UNIT + OPERATING LIGHT + MOTOR CHAIR WEIGHT 218 kg
ADDITIONAL WEIGHT ON THE INSTRUMENT TRAY OF THE DENTAL UNIT
(with self-balancing of the arm): 1 kg
MAXIMUM ADDITIONAL WEIGHT ON THE INSTRUMENT TRAY OF THE
DENTAL UNIT (w/o self-balancing of the arm): 2 kg
“DAMA” MOTOR CHAIR
MEDICAL DEVICE CLASS I - By 93/42 EEC DIRECTIVE
ELECTRO MEDICAL EQUIPMENT CLASS I TYPE B - By CEI EN 60601-1 Standard
THE EQUIPMENT CANNOT BE USED WHEN FLAMMABLE ANESTHETIC MIXTURES CONTAINING AIR OR
OXIGEN OR NITROUS OXIDE ARE PRESENT
POWER SUPPLY VOLTAGE 230 V~
SINGLE-PHASE A.C. at 50/60 Hz
POWER OF OPERATION COMMAND 24 V
INTERMITTENT OPERATION 1 min of work
14 min of rest
WHOLE WEIGHT 135 kg
HEIGHT FROM THE POINT OF SEAT “DAMA” for “Puma Eli” “DAMA” for “Puma Eli”
right-hand version ambidextrous version
min 36 cm min 41 cm
max 79 cm max 84 cm
BACKREST HEIGHT FROM THE FLOOR “DAMA” for “Puma Eli” “DAMA” for “Puma Eli”
right-hand version ambidextrous version
min 40 cm min 45 cm
max 83 cm max 88 cm
MAX. INCLINATIONS
MAX LIFTING CAPABILITY 300 kg
Summary