GNATUS Biovac Sec User manual

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Technical name: Vacuum dry bomb for dental ofces.
Brand: Gnatus
Model: Biovac Sec
Trade name: Biovac Sec
Manufacturer/ Distribuitor:
GNATUS - EQUIPAMENTOS MÉDICO-ODONTOLÓGICOS LTDA.
Rod. Abrão Assed , Km 53+450m - Cx. Postal 782 CEP 14097-500
Ribeirão Preto - S.P. - Brasil
Fone [phone] - Fax [phone]
C.N.P.J. 48.015.119/0001-64 - Insc. Est. 582.329.957.115
www.gnatus.com.br - [email protected]
Technical Duties: Gilberto Henrique Canesin Nomelini
CREA-SP: 0600891412
INSTRUCTIONS OF USE
ATTENTION
For 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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INDEX
PRESENTATION OF MANUAL ........................................................................02
DESCRIPTION OF THE EQUIPMENT ...............................................................04
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION .....06
TECHNICAL SPECIFICATIONS .......................................................................07
- Technical characteristics .................................................................................07
- Dimension ....................................................................................................08
- Symbologies of packaging ..............................................................................09
- Symbologies of product ..................................................................................09
- Standards applied .........................................................................................09
- Contents of the accessible and inaccessible markings .........................................10
INSTALLATION OF EQUIPMENT ....................................................................10
OPERATION OF EQUIPMENT .........................................................................12
PRECAUTIONS, RESTRICTIONS AND WARNINGS ..........................................13
- Conditions of transport and storage .................................................................13
- Environmental conditions of operation ..............................................................13
- Sensitiveness to environmental conditions foreseeable in normal situations of use .13
- Recommendations for preserving the equipment. ...............................................13
- Precautions and warnings “during the installation” of equipment ..........................13
- Precautions and warnings “during the use” of equipment ....................................14
- Precautions and warnings “after” the use of equipment.......................................14
- Precautions and warnings during the “cleaning and disinfection” of equipment .......14
- Precautions in case of alteration in the functioning of equipment ..........................14
- Precautions to be adopted against foreseeable or uncommon risks,
related to the deactivation and abandoning of equipment ...................................15
- Additional procedures for reuse .......................................................................15
CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION............15
- Clean the exterior of the equipment .................................................................15
- Internal cleaning of suction ducts.................................................................... 16
- Cleaning lter ...............................................................................................16
- Preventive maintenance.................................................................................. 1 8
- Corrective maintenance................................................................................. 18
UNFORESEEN EVENTS – SOLUTION OF PROBLEMS ........................................18
WARRANTY OF EQUIPMENT ..........................................................................19
FINAL CONSIDERATIONS ..............................................................................19

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Dear Customer
Congratulations. You have made a good choice when you decided to buy a GNATUS
QUALITY product comparable to the best products available in the World. This manual is a
general presentation of your product and it will give you important details to help you to
solve possible problems.
Please, read it and keep this with you.
Identication
Technical name: Vacuum dry bomb for dental ofces.
Brand: Gnatus
Model: Biovac Sec
DESCRIPTION OF THE EQUIPMENT

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Biovac Sec
The GNATUS Biovac Sec was designed for a high-powered suction that absorbs efciency
saliva and residues, using a technology that dispenses water in the vacuum generation
system, besides it supplying the needs of bio safety in general dental practice.
With this technology, the concern with water consumption it’s dispensable, considering
this zero consumption. Without the retainers use or mechanicals seals, which usually has
the same retention or sealing function, the Biovac secs dispense the routine maintenance
remission on these agents, unconcerned the customers with water or leaks levels.
The Biovac sec can be connected to water units, Vacuum Bomb II Kit and Vacuum Bomb
IV. Made in steel structure with high corrosion resistance, with rounded corners and easy
cleaning, it allows the consistently day-by-day operation for many years.
Plain high brightness paint, based on epoxy, cured in polymerized oven in 250ºC. This
machine is resistant to corrosion and cleaning materials.
With 1/2HP power or 0.37 KW, it’s possible to operate until three offices
simultaneously.
The Biovac sec has rubbish ltering system, localized in bomb’s suction input.
This system warrants greater safety, avoiding crashes, increasing the life’s equipment.
The air contamination is avoiding by the direct sewage discharge system.
Compact and silent, the Biovac Sec is endowed with an acoustic system, with anti-
vibration mounts and rubber feet. It’s ideal to be installed next to your clinical ofce.
Physical principle used by Biovac sec equipment
The Biovac Sec operates with a rotative turbines principle. This water running conception
is not used to vacuum produce, which results in considerable water economy.
With this system, the vacuum bomb operates by dry form. The group has as main
functional parts: System actuation electric motor and reservoir with dendrites lter
separator.
Indication of Equipment
This equipment is for dental use use only. It must be operated and utilized by specialized
professional (certied 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 utilization of correct instruments and it should to be in perfect conditions of the use, and
to protect the professional, the patients and others, in the eventual danger situation.
Purpose of the equipment
The Biovac Sec is indispensable equipment for dental procedures, besides sucking blood,
saliva and residues suction, this machine has a high power suction, which effectively reduces
bacterial aerosols, helping in biosafety practices dentistry.
DESCRIPTION OF THE EQUIPMENT

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01 - Debris separator access cover.
02 - 10A bipolar Switch.
03 - Power input connector.
MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION
BIOVAC SEC
03
01
04
02
05
Vacuum
pump kit ll Vacuum pump kit lV
OPTIONAL
04 - Power input cable.
05 - Rubber foot buffer

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TECHNICAL SPECIFICATIONS
Model
Biovac Sec
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
Reservoir capacity
1 L
Maximum vacuum
110 mmHg
Noise besides the equipment
74 db (A)
Air displacement
Upper to 380 L/min
General
Power
Voltage and power frequency
127 V~ 60 HZ
220/240 V~ 50/60 Hz
Control voltage
24 V~
Motor power
1/2 HP - 0,37 KW
Dry BV total power
770 VA
Rated current
4,7/5,3 A (127 V)
3,2/3,5 A (220/240 V)
Net weight
29,200 Kg
Gross weight
34,200 Kg
Weight

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TECHNICAL SPECIFICATIONS
Dimensions (mm)

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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 / or
stored with the harrows up.
Packing to be transported and /
or stored with care (should not
suffer drop and neither receive
impact).
Packing to be transported and
/ or stored avoiding humidity,
rains and wet oor.
The packing must be stored and
transported away from direct
sun light exposure.
Temperature limit for the
packing to be stored or
transported.
Landing (in many parts of
the equipment) indicates the
condition of being landed.
Careful: It indicates an
important instruction for the
operation of the product. Not
following it can cause dangerous
malfunctioning.
Note: It indicates useful
information for operation of the
product.
Important: It indicates an
instruction of safety for operation
of the product. Not following it,
can lead to serious danger to
the patient.
BF type equipment
Product symbols
Packing symbols
TECHNICAL SPECIFICATIONS
Warning - Consult the manual
Turned off
Turned on General Warning
Standards
This equipment was designed, manufactured and tested in compliance with the
following standards:
NBR 60601-1:1997 – Electromedical Equipment - Part 1: General prescriptions for safety;
NBR ISO 14971:2004- Medical devices - application of risk management medical devices;
NBR ISO 9687: 2005 - Dental equipment - graphical symbols;
EN ISO 13485-2003 - Quality systems - medical devices;
IEC 60601-1-2:2007 – Electromagnetic Compatibility.

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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 installation
executed 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 technical
assistance (Gnatus).
Content of accessible and non-accessible demarcations
TECHNICAL SPECIFICATIONS
INSTALLATION OF EQUIPMENT
The materials used to produce the equipment are Biocompatible.

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INSTALLATION OF EQUIPMENT
Below are two options for installation of the Biovac Sec in the ofce.
• Option 1: Vacuum bomb localized besides connection box.
• Option 2: Vacuum bomb localized inside the closet.
For the vacuum bomb installation, check these following points:
- Sewer – Can be connected directly to the raw sewage (you can not return for having
drainage by gravity is not generating pressure in the sewer).
- Electric jack - 3 x 1,5mm2 wires (network/ground).

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INSTALLATION OF EQUIPMENT
OPERATION OF EQUIPMENT
For the Biovac Sec operation,
you just need to remove the
support suctor (01). The bomb will
automatically in operation. Set
the aspiration ow, as required by
handle (02) engaged in Suctorian
moving up or down.
Replacing the Suctorian at the
initial position, the Biovac will turn
off automatically. In this moment,
the machine will dispose the liquid
reservoir.
The Biovac Sec will turn off also
if the reservoir reaches 1 L, when
it happens the reservoir will empty
(about 10s) and then the bomb will
be ready to use. This whole process
is automatically.
02
01
How you can let your Biovac Sec more
silent:
If your Biovac Sec is installed inside your ofce,
put a 3/4“ hose (not included) in damper located
at the lower Biovac Sec and let the other extremity
outside the ofce. This procedure decreases the
pump noise.
Note: This procedure is not required for Biovac
Sec operation. Consult a technician.
Vacuum pump kit ll
(Not included)

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- The equipment has been planned not to be sensitive to interference such as magnetic
elds, 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
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 oor;
- 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 maximum
stack quantity specied in the packaging;
- Transportation and storage temperature range: -12°C to 50°C;
- Transportation and storage relative humidity range: 0°C to 90°C.
- Ambient temperature range: +5°C to +45°C;
- Operation relative humidity range: 30% to 75% (non condensing);
- Atmospheric pressure range: 700 hPa to 1060 hPa (525 mmHg to 795 mmHg).
Operation ambient conditions
Transportation and storage
- 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 equipment in a place where it will not get wet.
- Install the equipment in a place where it will not be damaged by pressure, temperature,
humidity, direct sunlight, dust, salts, or sulfur compounds.
- This equipment was not planned for use in an environment where vapors, anesthetic
mixtures in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 rst use and/or after long interruptions from work such as vacations, clean
and disinfect the equipment; eliminate air and water deposited in the internal hoses.
Precautions and warnings“during the installation”of quipment
The Equipment maintains its condition of safety and efcacy, provided that it is
maintained (stored) as mentioned in this instruction of use. Thus, the equipment
will not lose or alter its physical and dimensional features.
Recommendations for the dental equipment maintenance.
Your 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 neglected due to several reasons and circunstances. Therefore, here
are some important reminders for your daily routine. Try to follow these simple rules, which
will save you a lot of time and will avoid unnecessary expenses once they start making part
of your working procedure.

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PRECAUTIONS, RESTRICTIONS AND WARNINGS
- The equipment should only be operated by duly enabled and trained technicians (Dental
Surgeons, Capacitated Professionals)
- 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.
- After each patient leaves, perform the suction of 250 ml of clean water.
- After using the equipment, clean and disinfect all the parts which may be in contact
with the patient.
- This equipment must be installed so that it is level.
Precautions and warnings during the“cleaning and disinfection”
of equipment
- Before cleaning the equipment, turn off the main switch.
- Avoid spilling water, 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.
- Never use detergent or any foaming product to make the internal cleaning of the tubes
of suction of Kit Bio-Vac and of the Biovac Sec.
- 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

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PRECAUTIONS, RESTRICTIONS AND WARNINGS
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 uncommon
risks, related to the deactivation and abandoning of
equipment
Additional procedures for reuse
The equipment can be reused in undetermined, i.e. unlimited, quantities, only needing
to be cleaned and disinfected.
CORRECTIVE AND PREVENTIVE MAINTENANCE AND
PRESERVATION
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.
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.
Clean the exterior of the equipment
Important: In order to execute cleaning or any type of maintenance, ensure that the
equipment is disconnected from the electrical network.

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CORRECTIVE AND PREVENTIVE MAINTENANCE AND
PRESERVATION
Cleaning lter
USE PROTECTIVE GLOVES WHEN MANIPULATING THE FILTERS AND THE DRAINS.
WASTE DISPOSE AND CONTAMINATED PRODUCTS IN GARBAGE BIOLOGICAL.
The vacuum pump lter should be cleaned in each 15 days. Before cleaning, you should
make the sample suction (see solution preparation in the previous item).
To clean the lter, follow the procedure below:
- After the solution suction
through the Suctorian, remove
the Biovac Sec covers that
access to the conduit head (1).
- Release the cable clip (2).
2
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DAILY PROCEDURE FORINTERNAL CLEANINGOF SUCTION DUCTS
OF THE DRY VACUUM PUMP
(Hoses and internal parts of the Vacuum Pump ducts)
• After each patient leaves, perform the suction of 250 ml of clean water in each totally
open suctor;
• At the end of the working Day, perform the suction of the 250 ml mixture of bleach
mixed with 250 ml of clean water (proportionally divided in each used suctor);
WARNING:
• Never use foamy products in the suction (deep cleaner, detergents, oaters, etc), this
procedure may damage the internal parts of the dry vacuum pump’s engine;
• Never use the bleach solution for external cleaning of any equipment, because this
mixture is highly corrosive and may damage metal parts.

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- Remove two hoses
connected to reservoir (3)
and (4).
- Release the tank locks
cover (5).
- Lift the cover and
remove the lter by moving
it sideways (6) e (7).
- Remove the tank pulling it up (8).
- Wash the lter and the reservoir in current water.
- Clean the electrodes (9).
- Fit the lter and place the tube in the tank surrounding the electrodes (10).
Note: Do not miss this tube, because it avoids the foam electrodes.
- Making the inverse procedure, mount the reservoir and cover the Biovac Sec.
4
56 7
3
910 8

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CONSERVAÇÃO E MANUTENÇÃO CORRETIVA E PRE
VENTIVA
Note: Use gloves and other
systems of protection,
during the disinfection.
Attention: Do not use any
disinfectant spray, as the vapor
may be inammable, or it may
cause injury.
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 Maintenance
If 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.
Problem Probable cause Solution
- There is no suction,
when the ejector is taken
from the holder.
- Lever of adjustment of
emptying of the sucker is
shut.
- Circuit breaker in the “off”
position.
- Unplugged cable.
- Contact the electrodes
sealed by dirt or foam in the
reservoir.
- Proceed the adjustment of
the emptying through the
lever acoording to need.
- Turn on the circuit bre-
aker.
- Plug the cable.
- Contact the electrodes
sealed by dirt or foam in the
reservoir.
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

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WARRANTY OF EQUIPMENT
This equipment is covered by the warranty terms counting from the date of installation,
as speci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 certicate;
- 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 Certicate comes with the product and must be lled in upon the date
of installation by the Gnatus Authorized Technician.
- Queries and information: GNATUS Help Desk ([phone].
- 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 specications 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 spedic tools for the correct maintenance
of your equipment.
Doubts and information: GNATUS Call center (55-16) 2102-5000.
FINAL CONSIDERATIONS

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