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Manuais do Proprietario - Gnatusgnatus.com.br/2005/images/online/manuais_759338_Bio Vac II.pdf · Quality Management System certificate in accordance to ISO 9001:2000 and ISO 13485:2003

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INDEX

Product Description ...............................................................................................................03Warranty of the Equipment ...................................................................................................04General Data .........................................................................................................................05Technical Specifications .......................................................................................................06Symbols .................................................................................................................................07Dimensions ............................................................................................................................08Installation ..............................................................................................................................10Operation ...............................................................................................................................12Maintenance ..........................................................................................................................12Precautions ...........................................................................................................................12Cleaning .................................................................................................................................13Troubleshooting ....................................................................................................................14Final Considerations ..............................................................................................................14

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Congratulations. You have made a good choice when you decided to buy a GNATUS QUALITYproduct comparable to the best products available in the World. This manual is a general presentationof your product and it will give you important details to help you to solve possible problems.

Please, read it and keep this with you.

DEAR CUSTOMER

PRODUCT DESCRIPTION

Vacuum Pump Bio-Vac IIGNATUS BIO-VAC II, was designed to supply bio-safety needs on the dental activity. Equipment

with high suction power, that absorves with more efficiency the saliva and residues.Built in bronze-aluminum alloy, high resistant to corrosion, which allows years of use on a daily

basis.Steel structure, covered with resistant material, and easy cleaning round corners.1/2” HP ≅ 0,37 KW power, allowing to operate until 2 dental office simultaneous.DEBRIS FILTERING SYSTEMLocated on the suction inlet of the pump. This system guarantees greater safety, avoiding jams and

wears, increasing the life span of the equipment.The contamination of the environment is avoided, thanks to the direct sewer discharge system.Compact and silent, the Bio Vac II is ideal for the installation next to your office.

Continuous with intermittent load, 1h sec. operating with a pause of 15 min.

Kit Vacuum pump II (Optional)The kit has 1 automatic activating ejector, and easy handling adjustment, which allows the user to

adjust the suction flow, reducing the risk of contamination by the aerosol, bringing a better view of the

operation field, and better comfort for the patient.

Bio Vac II kit can be coupled to the dental light’s column, or cabinet sides.

Note: Give preference to hand pieces and peripherals developed in accordance with requirements

of directive 93/42/EEC (with CE mark).

Quality Management System certificate in accordance to ISO 9001:2000 and ISO 13485:2003

standart, assuring that equipments are produced in base with standardized procedures, meeting the

quality continually improve.

Products manufactured in agreement with RDC-59 - ANVISA (Sanitary Surveillance National Agency)

with guarantees accomplishiment to the sanitary legislation according to BPF (Good Manufacturing

Procedures). In order to comply with directive 93/42/EEC for CE Mark purpose, it is defined that the life

span of this product is estimated in 05 years provided that the enduser follows the requirements and

instructions of this manual.

IMPORTANT:• This equipment is for dental use use only. It must be operated and utilized by specialized

professional (certified professional, according to the legislation of the country) and following the

instructions of the manual. The operation of the equipment required, for the professional, the utilizationof correct instruments and it should to be in perfect conditions of the use, and to protect theprofessional, the patients and others, in the eventual danger situation.

• This equipment can’t be used in the presence of inflammable anesthetics or products that maycause explosion.

•After finish life-cycle of the equipment, this equipment is throw way, so it should to be destroyedin appropriate area (according to the legislation of the country).•To guarantee the safe functioning of your equipment, use only the assemble configurations

(Dental Chair, Dental and Water Units and Dental Light) supplied by Gnatus Authorized Dealers /Technical Assistance.

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WARRANTY OF THE EQUIPMENTThis warranty covers product’s manufacturing faults for the warranty period and standards

specified on the Warranty Certificate. The Warranty Certificate is attached to product, and must becompleted by the Authorized Technician when equipment is installed.

Doubts and information: GNATUS Call center (55-16) 2102-5000.

PRODUCT DESCRIPTION

Please pay attention to the local law considering the installation condition and throw it away theresidues and others that were absorved by the pump.

OBSERVATION:• Application together with anesthetic products that could be inflammable in the presence of air,

oxygen or nitrous oxide: Not recommended

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GENERAL DATA

Maintenance of the equipmentThe equipment doesn’t need preventive maintenance, however when there is any problem that this

manual can’t solve, ask for an authorized Gnatus technician.

List of pieces and circuit schemeGnatus Company declares that the supply of the circuit scheme, list of pieces or any other

information that propitiate technical attendance for the user, can be request if there is an agreementbetween the user and Gnatus Company.

Under current protectionThe equipment features a safety device (circuit brea-ker) in case overcurrent.

01 - Circuit breaker

02 - Light indication (ON/OFF)

03 - Debris filter

04 - Protection cover

05 - Ejector holder

06 - High power ejector terminal

07 - Light indication working equipment

08 - Fixing plate

04

03

02

01

05

0708

06

Kit Bio Vac II

Optional

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TECHNICAL SPECIFICATIONS

• Tension of Feeding

110/220V~

• Frequency

50/60Hz

• Motor

1/2 CV - 0,37 KW

• RPM

2870 - 50 Hz

3444 - 60 Hz

• Nominal Power

665 VA

• Entrance Power

1140 VA

• Nominal Current

4.6 A (220 V~)

9.2 A (110 V~)

• Tension of the Command

24 V~

• Maximun Vacuum

400 mm/Hg

• Consumption of Water

0.400 l/min

• Net weight (Vacuum

Pump)

21.90 Kg

• Gross weight (Vacuum

Pump)

24.70 Kg

• Net weight (Kit

Vaccum pump)

0.80 Kg

• Gross weight (Kit

Vaccum pump)

1.46 Kg

• Degree of protectionagainst electric shock:BF type

• Water leak protectionIPX0

• Operation

Continuous with intermittentload, 1h sec. operatingwith a pause of 15 min.

StandardsThis equipment was designed, manufactured and tested in compliance with the following standards:

NBR-IEC série 601-1 Equipamento Eletromédico - Parte 1: Prescrições gerais para segurança;

NBR ISO 6875:1998 - Equipamento odontológico – Cadeira odontológica de paciente;

EN 980:2003 (Ed. 2) - Graphical symbols for use in the labelling of medical devices;

ISO 14971 - Medical devices - application of risk management medical devices;

ISO 9687: 1993 - Dental equipment - graphical symbols;

ISO 13485-2 - Quality systems - medical devices;

ISO 780 - Packaging - pictorial marking for handling goods.

EN 60601-1 (1990);Amendment 1 EN 60601-1 (1992);

Amendment 2 EN 60601-1 (1995);Amendment13 EN 60601-1 (1995);

EN 60601-1-2 (2001);

NBR IEC 601-1 (1994);Emenda 1 NBR IEC 601-1 (1994);

NBR IEC 601-1-2 (1997);CISPR 11, edição 3.1 (1999);

IEC 61000-4-2 (1999);

IEC 61000-4-3 (1998);IEC 61000-4-4 (1995);

IEC 61000-4-5 (1995);IEC 61000-4-6 (1996);

IEC 61000-4-11 (1996);

Special providence or particular conditions for installation- Check the electric net, it must be compatible with the specified one in the equipment.- Verify the thread earth, it must be turned off correctly.OBS: These information also make part of the Manual of Installation and Maintenance of the

equipment that can be found with the authorized Gnatus technician.

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05

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TECHNICAL SPECIFICATIONS

Packing symbols

Packing (Kit Vacuum Pump) to bestored with a maximum stack of 10units.

Packing (Vacuum Pump) to bestored with a maximum stack of 05units.

Packing to be transported and /or stored with care (should not sufferdrop and neither receive impact).

Packing to be transported and /or stored with the harrows up.

Packing to be transported and /or stored with care.

Temperature limit for the packing tobe stored or transported.

The packing must be stored andtransported away from direct sunlight exposure.

Warning - Consult the manual

B type equipment

Turned off position

Turned on position

BV ejector

Product symbols

Dangerous voltage

Equipament energizedequipment without energy

Transport and storage conditionsThe equipment must be transported and stored with the following observations:- Carefully, should not suffer drop and neither receive impact.- With the side of the arrow upward.- With humidity protection, not to expose to rains, sparkling of water or humidified floor.

Vacuum Pump- With maximum piling up of 05 units for storage.

Kit Vacuum Pump (Optional)- With maximum piling up of 10 units for storage.

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TECHNICAL SPECIFICATIONS

Dimensions (mm)

Kit Bio-Vac IIOptional

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Content of accessible and non-accessible demarcations

TECHNICAL SPECIFICATIONS

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INSTALLATIONThere are two options for Bio-Vac II installation.• Option 1: Vacuum pump located besides the connecting box• Option 2: Vacuum pump located inside a cabinet.

For option 2 vacuum pump installation, please consider:G-WATER - Water faucet Ø3/4” diameterI-SEWER - Must be independent from the rest of the sewer systems, to avoid reflow problems.Y-ELECTRICAL OUTLET 3x2,5mm2 (mains/ground).

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IMPORTANT:- The installation should be made by an authorized technician Gnatus.- Complementary informa-tion on hydraulics and electric, they meet in the Manual of Installation and

Maintenance in being able to not of the authorized technician Gnatus.

INSTALLATION

Voltage change

PC Board:Move the jumper as indicated on the image below.

Motor:110V~: On the motor bornes, connect the blue wire (1), with the orange wire (3), on L1. Connect

the white wire (2), with the yellow wire (4), on L2.

220V~: On the motor bornes, connect the white wire (2), with the orange wire (3). Connect theblue wire (1) on L1, and the yellow wire (4), on L2.

*As indicated on the motor identification plate.

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To start the Bio Vac II, just take out thesuctor (06) from the holder, the LED (07)will be ON, showing that the pump isalready working.

Adjust the aspiration emptyingaccording to the need, by the lever (09)coupled in the sucker, moving upward ordown. Putting back the sucker in the initialposition, the Bio-Vac II will turn offautomatically.

MAINTENANCE

Recommendations for the dental equipment maintenanceYour Gnatus equipment has been designed and developed according to the standards of modern

techology. Similarly to other kinds of equipment, it requires special care, which is many times neglecteddue to several reasons and circunstances.

Therefore, here are some important reminders for your daily routine. Try to follow these simplerules, which will save you a lot of time and will avoid unnecessary expenses once they start makingpart of your working procedure.

Precautions- Before beginning the operation of starting of the Bio-Vac II, be certified that the plug of the cable

of tension entrance is con-nected in the electric net, and that the registration of feeding of water isopen.

- The lack of water will cart in damages in the mechanical stamp and the Bio-Vac II won’t makeaspiration.

- Never use detergent or any foaming product to make the internal cleaning of the tubes of suctionof Kit Bio-Vac II and of the Bio-Vac II.

- In the end of the file, close the registration of water that feeds the Bio-Vac II and turn off thegeneral key of the clinic..

OPERATION

Kit Bio-Vac IIOptional

06

07

09

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MAINTENANCE

Cleaning of the filterCleaning of the filterCleaning of the filterCleaning of the filterCleaning of the filterThe filter of Vacuum Pump should be daily

clean. Before doing the cleaning of the filters itshould be made the suction of the solution. (seethe preparation of the solution in the previous item).

After the suction of the solution through thesuctor, take the lid (10) and the filter (11) andwash them in running water.

WARNING:ALWAYS USE PROTECTION GLOVES WHEN

MANIPULATING FILTERS AND DRAINAGES.THROW THE RESIDUES AWAY AND THE

CONTAGIOUS PRODUCTS AS PER LAW IN YOURCOUNTRY.

Cleaning and desinfectionAfter each patient it is necessary to do the suction of the disinfectant

solution and deobstruent, avoiding the risk of crossed contamination andincreasing the useful life of the equipment.

Indicated product composition:Isopropyl Alcohol, hydro-acetic Acid, Phosphoric Acid and Distilled water

s.q.Important: Use only non foaming products.After the suction procedure, autoclave the ejectors, removing them from

the handpieces, as shown in the figure.Attention:Be sure, that when the disinfection is being made, that both suction valves

are open, one for liquid and the other for air.

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Cleaning the equipment

To clean the equipment, we recommend the use of “BactSpray (Reg nº MS:3.2079.0041.001-5) or any other similar product:

Active component: Benzalkonium chloride (tri-quaternary ammonium) Solution 50%................................................. 0.329%

Chemical composition: Butyl Glycol, Decyl polyglucose, Sodium Benzoate, SodiumNitrate, Essence, Deodorized Propane / Butane, demineralized Water.

For more information concerning cleaning procedures, see manufacturer’sinstructions.

WARNING:• In order to prevent risks and damages to equipment, make sure that the liquid does

not enter into the unit. • The application of other solvent-based cleaning products or sodium hypochloride

isn’t recommended, because they may damage the equipment.

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FINAL CONSIDERATIONS

The most important aspect related to equipment care is that concerning spare parts.To guarantee the life span of your equipment, use only original Gnatus spare parts. They are

sure to follow the technical specifications and standards required by Gnatus.We must also point out to you our chain of authorized dealers. Only dealers that make part of this

chain will be able to keep your equipment constantly new for they count on technical assistants whohave been trained and on spedific tools for the correct maintenance of your equipment.

Doubts and information: GNATUS Call center (55-16) 2102-5000.

TROUBLESHOOTING

ImprevistoProblem: Probable Cause: Solution:

- *There is no suction,when the ejector is taken fromthe holder.

- Lever of adjustment ofemptying of the sucker is shut.

- Registration of feeding ofwater of the Pump is closed.

- Circuit breaker in the “off”position.

- Unplugged cable.

- Proceed the adjustment ofthe emptying through the leveracoording to need.

- Open the registration offeeding of water of Pump.

- Turn on the circuit breaker.- Plug the cable

ATTENTION:Any other problem that could happen with its equipment, should only be repaired by an Authorized

Technician GNATUS.The bad use, negligence or maintenance not made by technician authorized by the maker, will imply

in the loss of the warranty.

* In case of continous fails, request to the attendance section to the customer a authorizedtechnician Gnatus.

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