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Technical name: Dry vacuum pump for podiatric clinics

Brand: Gnatus

Model: Bio Vac Podo Trade name: Bio Vac Podo

Manufacturer/ Distribuitor:GNATUS - EQUIPAMENTOS MÉDICO-ODONTOLÓGICOS LTDA.Rod. Abrão Assed , Km 53+450m - Cx. Postal 782 CEP 14097-500Ribeirão Preto - S.P. - BrasilFone +55 (16) 2102-5000 - Fax +55 (16) 2102-5001C.N.P.J. 48.015.119/0001-64 - Insc. Est. 582.329.957.115www.gnatus.com.br - gnatus@gnatus.com.brTechnical Duties: Gilberto Henrique Canesin NomeliniCREA-SP: 0600891412

Owner’s manual (InsTruCTIOns OF use)

aTTenTIOnFor greater safety:Read and understand all the instructions contained in these

Instructions for Use before installing or operating this Equipment.Note: These Instructions for Use must be read by all the operators

of this Equipment.

PresenTaTIOn OF manual

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InDeXPRESENTATION OF MANUAL .........................................................................02

IDENTIFICATION OF EQUIPMENT .................................................................04

MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION .....06

TECHNICAL SPECIFICATIONS .......................................................................06- Technical characteristics .................................................................................06- Dimension ....................................................................................................08- Compatibility (EMC) .......................................................................................09- Symbologies of packaging ..............................................................................13- Symbologies of product ..................................................................................13- Standards applied .........................................................................................13- Contents of the accessible and inaccessible markings .........................................14

INSTALLATION OF EQUIPMENT ....................................................................14

OPERATION OF EQUIPMENT .........................................................................15- Beginning .....................................................................................................15- Turning Bio Vac Podo ON and OFF in the Gradus Comfort Chair ............................15- Turning Bio Vac Podo ON and OFF in the Gradus Soft Chair .................................15- Articulated arm .............................................................................................15- Waste bag ....................................................................................................16- Changing the waste bag .................................................................................16

PRECAUTIONS, RESTRICTIONS AND WARNINGS ..........................................17- Conditions of transport and storage .................................................................17- Sensitiveness to environmental conditions foreseeable in normal situations of use .................................................................................17- Precautions and warnings “during the installation” of equipment ..........................18- Precautions and warnings “during the use” of equipment ....................................18- Precautions and warnings “after” the use of equipment ......................................18- Additional procedures for reuse .......................................................................18- Precautions and warnings during the “cleaning and disinfection” of equipment .......19- Precautions in case of alteration in the functioning of equipment ..........................19- Precautions to be adopted against foreseeable or uncommon risks, related to the deactivation and abandoning of equipment ....................................19

CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION............19- Clean of the equipment ..................................................................................19- Cleaning the waste collector............................................................................20- Preventive maintenance...... .......................................................................... 20- Corrective maintenance................................................................................. 20

UNFORESEEN EVENTS – SOLUTION OF PROBLEMS ........................................21

WARRANTY OF EQUIPMENT ..........................................................................22

FINAL CONSIDERATIONS ..............................................................................22

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Dear CustomerCongratulations. You have made an excellent choice by purchasing a Gnatus quality

product, among the most advanced and innovative in the world. This manual provides a general overview of your product and provides important details to help you solve potential problems. Please read this manual and keep it for your reference.

IdentificationTechnical Name: Dry vacuum pump for podiatric clinics

Brand Name: Gnatus

Brand: Bio Vac Podo

IDenTIFICaTIOn OF THe eQuIPmenT

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Description of equipmentBio Vac Podo GNATUS was designed to provide an ideal vacuum level with high suction

power that effectively aspires tiny airborne particles during podiatric practice.It has a waste collector with an adjustable arm, providing total freedom of movement

and allowing several positions aiming to better workplace ergonomics.Without the use of retainers or mechanical seals which usually have the holding or

sealing function, dispensing periodic maintenance in these agents, leaving customers unconcerned with levels of leakage with easy removal of the dust container, facilitating asepsis and maintenance.

Steel structure with high corrosion resistance, with rounded corners and easy cleaning which allows consistent operation day after day for many years.

Smooth high-gloss epoxy based paint, polymerized in an oven at 250 ° C, resistant to corrosion and cleaning materials.

Compact and quiet, the Bio Vac Podo is provided with a acoustic cover and anti-vibration system with cushions to motor fixation and rubber feet, making it suitable for installation next to your office.

Physical principle used by equipmentBio Vac Podo operates on the principle of rotary turbines, i.e., basically consisting in an

electric motor designed to create a stream of high velocity air that moves through a nozzle connected to a flexible hose and also has a disposable bag for storage of the aspirated particles.

Indication of equipmentThis equipment is for exclusive podiatric use and should be used and handled by a qualified

person (professional properly regulated, according to local legislation of the country) following the instructions contained herein. It is the user’s obligation to use only the equipment in perfect condition and protect themselves, patients and others from possible dangers.

Purpose of equipmentBio Vac Podo is a must have equipment in podiatric procedures, because besides having

the particles suction, it also has a high-power displacement of air which effectively reduces the tiny particles suspended in the air during podiatric practice.

IDenTIFICaTIOn OF THe eQuIPmenT

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01 - Waste bag access lid02 - 10A bipolar Switch03 - Power input connector04 - Power input cable

mODules, aCCessOrIes, OPTIOns anD maTerIalsOF COnsumPTIOn

Bio Vac Podo

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01

04

02

05

05 - Rubber foot buffer06 - Articulated arm07 - Waste collector

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TeCHnICal sPeCIFICaTIOns

Net weight29,200 Kg

Gross weight34,200 Kg

weight

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TeCHnICal sPeCIFICaTIOns

Model

Bio Vac Podo

Classification of equipment as per standard IEC 60601-1

Protection against Electric Shock - Type BF and Class II Equipment (IEC 60601-1)

Protection against dangerous ingress of water

IPX 0

Mode of Operation

Continuous operation

Maximum vacuum

55 mmHG

Noise besides the equipment

74 db (A)

Air displacement

480 nl/min

General

Power

Voltage and power frequency

127 V~ 60 HZ220/240 V~ 50/60 Hz

Control voltage

24 V~

Motor power

1/2 HP - 0,37 KW

Potência total

770 VA

Rated current

4,7/5,3 A (127 V)3,2/3,5 A (220/240 V)

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TeCHnICal sPeCIFICaTIOns

Dimensions (mm)

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TeCHnICal sPeCIFICaTIOnsPrecautions regarding electromagnetic Compatibility (emC)

Electro-medical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this document. Bio Vac Podo complies with the EMC requirements according to IEC 60601-1-2.

Radio transmitting equipment, cellular phones, etc. shall not be used in close proximity of the device since they could influence the performance of the device. Particular precaution is required when using strong emission sources such as High Frequency surgical equipment and similar equipment so that the HF cables are not routed on or near the device.

If in doubt, please contact a qualified technician or Gnatus. Bio Vac Podo should not be used adjacent or stacked with other equipment. If adjacent or stacked use is necessary, Bio Vac Podo should be monitored to verify normal operation in the conPict.tion in which it will be used.

The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by Gnatus as replacements parts for internal components, may result in increasedemissions or decreased immunity of Bio Vac Podo.

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TeCHnICal sPeCIFICaTIOns

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TeCHnICal sPeCIFICaTIOns

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TeCHnICal sPeCIFICaTIOns

The materials used in constructing the equipment is Biocompatible.

Parts lists and circuit diagramsGnatus states that the provision of circuits diagrams, parts list, or any other information

that will provide technical assistance by the user, may be required, if previously agreed between the Company and Gnatus.

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Maximum stacking: It determines the maximum quantity of boxes which can be stacked during transportation and storage “as per packaging”.

Packing to be transported and / orstored with the harrows up.

Packing to be transported and /or stored with care (should notsuffer drop and neither receiveimpact).

Packing to be transported and/ or stored avoiding humidity,rains and wet floor.

The packing must be stored andtransported away from direct sun light exposure.

Te m p e r a t u r e l i m i t f o r the packing to bestoredor transported.

Landing (in many parts of the equipment) indicates the condition of being landed.

Careful : I t ind icates an important instruction for the operation of the product. Not following it can cause dangerous malfunctioning.

Note: I t i nd i ca te s u se fu l information for operation of theproduct.

BF type equipment

Product symbols

Packing symbols

TeCHnICal sPeCIFICaTIOns

Advertência - consulte o manual

Turned off

Turned on

General Warning

standardsThis product conforms to the following standards:NBR 60601-1:2005 – Electromedical Equipment - Part 1: General prescriptions for safety;NBR ISO 14971:2007- Medical devices - application of risk management medical devices;EN ISO 13485-2003 - Quality systems - medical devices;IEC 60601-1-2:2007 – Electromagnetic Compatibility.ISO 9001:2008 -Quality Management System - Requirements;RDC 59/2000 - Good manufacturing practices for medical products - ANVISA;

Important: It indicates an instruction of safety for operation of the product. Not following it, can lead to serious danger to the patient.

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- This equipment shall only be able to be unpacked and installed by a Gnatus authorized technician, under penalty of losing the warranty, as only (s)he has the information, suitable tools and training required to execute this task.

- Gnatus bears no responsibility for damages or accidents caused by poor installationexecuted by a technician not authorized by Gnatus.

- Only after the equipment has been installed and duly tested by the authorized technician representing Gnatus, will it be ready to start work operations.

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.

The installation of this equipment requires specialized technicalassistance (Gnatus).

Content of accessible and non-accessible demarcations

TeCHnICal sPeCIFICaTIOns

InsTallaTIOn OF eQuIPmenT

The materials used to produce the equipment are Biocompatible.

Bio Vac Podo arm was designed for installation behind the columns of the Gradus Comfort and Gradus Soft chairs.

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OPeraTIOn OF eQuIPmenT

To turn Bio Vac Podo on in the Gradus Comfort Chair, press the upper button on the control pedal (lateral Pic.); a green led will turn on over the button, signaling that Bio Vac Podo is turned on; to turn it off, just press the same button once more.

Turning Bio Vac Podo On and OFF in the Gradus Comfort Chair

- Turn on the main key behind Bio Vac Podo.- Place the waste collector near to the operation area for easier aspiration of the

suspended particles.- Turn Bio Vac Podo on.

Beginning

To turn Bio Vac Podo on in the Gradus Soft Chair, press the button below and at the side of the chair (see Pic.); to turn it off, press the button again.

Turning Bio Vac Podo On and OFF in the Gradus soft Chair

GRADUS COMFORT

GRADUS SOFT

B e s i d e s f e a t u r i n g s e v e r a l articulations, the Bio Vac Podo arm is also extensible, bestowing the operator total freedom of move and allowing for appropriate positioning for the widest variety of situations.

articulated arm

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OPeraTIOn OF eQuIPmenT

In order to ensure perfect functioning of your Bio Vac Podo, always use original “Electrolux” disposable bags for “Max Trio e Trio” vacuum

cleaners. Those are easily found in the market, but you may also purchase them from Gnatus Customer Services asking for product number “300054370”.

- Remove the waste bag access pane, pulling it up. Pic. 01

- Release the two reservoir pane latches. Pic. 02

- Remove the cap, pulling it up. Pic. 03

Changing the waste bag

Pic. 01

Pic. 03 Pic. 02

The waste bag must be replaced whenever the user senses a decrease in aspiration efficiency.

waste bag

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OPeraTIOn OF eQuIPmenT

- Remove the waste bag, pulling it. Pic. 04

- Fit the new bag in and close your Bio Vac Podo, performing the previous steps in the inverse sequence.

Pic. 04

PreCauTIOns, resTrICTIOns anD warnInGs

This equipment must be transported and stored observing the following directions:- Avoid falls and impacts;- Keep it dry, do not expose it to rain, water drops or wet floor;- Keep it away from water and direct sunlight, and in it original wrapping;- Don’t move it over irregular surfaces, protect it from rain and observe the maximumstack quantity specified in the packaging;- Transportation and storage temperature range: -12°C to 50°C.- Ambient temperature range recommended by Gnatus +10 ° C to +35 ° C.

ATTENTION: The equipment should only be used with power input cable supplied by Gnatus. Otherwise, it may cause an increase in the emissions of reduction in the immunity of the equipment.

Transportation, storage and operation.

The Equipment maintains its condition of safety and efficacy, provided that it is maintained (stored) as mentioned in this instruction of use. Thus, the equipmentwill not lose or alter its physical and dimensional features.

The equipment has been planned not to be sensitive to interference such as magnetic fields, external electrical factors, electrostatic discharge, pressure or variance of pressure, provided that the equipment is installed, maintained, clean, preserved, transported and operated as per this instruction for use.

sensitivity to environmental conditions in normal situations of use

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PreCauTIOns, resTrICTIOns anD warnInGs

- The equipment should only be installed by Gnatus authorized technical assistance or technicians.

- Check that the socket in which the device will be connected has a ground connection. According to the ABNT standard, this is essential for the safe operation of the system;

- Position the unit in a place where it will not get wet.- Install the unit in a place where it will not be damaged by the pressure, temperature,

humidity, direct sunlight, dust, salts.- The unit should not be submitted to inclination, excessive vibrations, or blows (including

during transportation and handling).- This equipment was not planned for use in an environment where vapors, anesthetic

mixtures infl ammable with air, or oxygen and nitrous oxide can be detected.- Check the voltage of the equipment at the moment of executing the electrical installation.- The equipment must be grounded correctly.- Before the fi rst use and/or after long interruptions from work such as vacations, clean

and disinfect the equipment.

Precautions and warnings “during the installation” of quipment

- The equipment should only be operated by duly enabled and trained technicians- If any maintenance should be required, only use services of the Gnatus Authorized

Technical Assistance.- The equipment has been manufactured to handle both continuous.- Although this equipment has been planned in accordance with the standards of

electromagnetic compatibility, it can, in very extreme conditions, cause interference with other equipment. Do not use this equipment together with other devices very sensitive to interference or with devices which create high electromagnetic disturbance.

Precautions and warnings “during the use” of equipment

Gnatus shall not be responsible for: - Use of the equipment differing from that for which it is intended.- Damages caused to the equipment, the professional and/or the patient by the incorrect

installation and erroneous procedures of maintenance, differing from those described in these Instructions for use which come with the equipment or by the incorrect operation of it.

Precautions and warnings “after” the use of equipment- Turn off the main switch of the dental set when it is not in use for an extended period

of time.- Always maintain the equipment clean for the next operation.- Do not modify any part of the equipment. Do not disconnect the cable or other

connections without need.

additional procedures for reuseThe equipment can be reused in undetermined, i.e. unlimited, quantities, only needing

to be cleaned and disinfected.

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PreCauTIOns, resTrICTIOns anD warnInGsPrecautions and warnings during the “cleaning and disinfection”of equipment

- Before cleaning the equipment, turn off the main switch.- Avoid spilling water, even accidentally, or other liquids inside the equipment, which could

cause short circuits.- Do not use microabrasive material or steel wool when cleaning, or employ organic solvents

or detergents which contain solvents such as ether, stain remover, gasoline etc.

If the equipment has any abnormality, check if the problem is related to any item listed in the topic of unforeseen events (failures, causes and solutions). If it is not possible to resolve the problem, turn off the equipment, remove the power supply cable from the socket and contact your representative (Gnatus).

Precautions in case of alteration in the functioning of equipment

In order to avoid environmental contamination or undue use of the Equipment after it has become useless, it should be discarded in the suitable place (as per the local legislation of the country).

- Pay attention to the local legislation of the country for the conditions of installation and disposal of residue.

Precautions to be adopted against foreseeable or uncommonrisks, related to the deactivation and abandoning of equipment

COrreCTIVe anD PreVenTIVe maInTenanCe anDPreserVaTIOn

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,Sodium Nitrate, Essence, Deodorized Propane / Butane, demineralized Water.For more information concerning cleaning procedures, see manufacturer’s

instructions.

NOTE: The registration at the Ministry of Health of the “BactSpray” is executed separately from the product described in this manual, as the “BactSpray” is not manufactured by Gnatus.

Clean of the equipmentImportant: In order to execute cleaning or any type of maintenance, ensure that the equipment is disconnected from the electrical network.

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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.

Cleaning the waste collectorThe waste collector may be removed

for ease of cleaning, all you have to do is to pull it, unplugging it.

Clean with 70% ethanol or running water and neutral soap.

Wear gloves and other protection equipment during cleaning.

The equipment should be calibrated routinely, as per the legislation in force in the country. But never with a period exceeding 3 years.

In order to protect your equipment, seek Gnatus technical assistance for periodic revisions of preventive maintenance.

Preventive maintenance

Corrective maintenanceIf the equipment has any abnormality, check if the problem is related to any of the items

listed in the item Unforeseen Events (situation, cause and solution). If it is not possible to solve the problem, turn off the equipment, and request Gnatus technical assistance.

COrreCTIVe anD PreVenTIVe maInTenanCe anDPreserVaTIOn

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Upon coming across any problem in operation, follow the instructions below to check and repair the problem, and/or get in touch with your representative.

unFOreseen eVenTs – sOluTIOn OF PrOBlems

Problem Probable Cause solutions-Bio Vac Podo inoperative -Disarmed breaker;

-Cable not connected to the mains

-Activate the breaker;-Connect to the mains.

-Low efficiency in suction - Damaged fanfold hose- Full debris bag

- Replace the fanfold hose- Replace the bag of debris

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warranTY OF eQuIPmenTThis equipment is covered by the warranty terms counting from the date of installation,

as specifi ed below; provided that the defect has occurred in normal conditions of use and that the equipment has not remained stored for more than 06 months counting from the issue date of the sales document until the date of the actual installation.

- WARRANTY TERMS: Verify the guarantee certificate;- LOSS OF THE WARRANTY:A) Attempt to repair using an inadequate tool or by unauthorized technicians;B) Installation of the equipment by an unauthorized technician;C) Damage arising from inappropriate storage or signs of infringement;D) Incorrect use of the equipment;E) Use of a cleaning product not indicated by the factory;F) Falls or blows which the equipment may undergo or lack of observation of an compliance

with the guidelines of the Owner’s Manual, which was delivered with the present document, together with the equipment. Repair or replacement of parts during the warranty period shall not extend the validity term of their warranty.

- This warranty doe snot exempt the customer from paying the service charge for the visit and the travel expenses of the technician, except when the customer sends the equipment to execute the maintenance inside the establishment of the technical assistance.

“Consumer Defense Code - art. 50, unique paragraph”.- The Warranty Certifi cate comes with the product and must be filled in upon the date

of installation by the Gnatus Authorized Technician.- Queries and information: GNATUS Help Desk (+55) 16 2102-5000.- Check the warranty term attached to this manual.

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 who have been trained and on spedific tools for the correct maintenance of your equipment.

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

FInal COnsIDeraTIOns

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