Seavo BioPack User manual

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PRESENTATION OF MANUAL
INSTRUCTIONS FOR USE
CAUTION
Technical Name: Sealer
Trade Name: BioPack
Model: BioPack
Brand: Saevo
Manufacturer / Distribuitor:
Alliage S/A Indústrias Médico Odontológica
C.N.P.J. 55.979.736/0001-45 - Insc. Est. 582.002.897.114
Rod. Abrão Assed, Km 53+450m - Cx. Postal 782 CEP 14097-500
Ribeirão Preto - S.P. - Brasil
Phone [phone]
Technical Duties: Ricardo J. Ravaneli
CREA-SP: 5060714523
For improved safety:
Read and understand all the instructions contained in the Instructions for Use before installation
or operation of this equipment.
Note: The Instructions for Use must be read by all persons that operate this equipment.

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INDEX
02 PRESENTATION OF MANUAL
04 IDENTIFICATION OF EQUIPMENT
06 MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION
07 TECHNICAL SPECIFICATIONS
07 General features
08 Dimensions
09 Packing symbols
09 Product symbols
10 INSTALLATION OF EQUIPMENT
11 EQUIPMENT OPERATION
12 PRECAUTIONS, RESTRICTIONS AND WARNINGS
12 Transportation, storage and operation
12 Sensitivity to predictable environmental conditions in ordinary situations of use
12 Precaution and warnings “during the installation” of the equipment
13 Recommendations for preserving the equipment
13 Precautions and warnings “during the use” of equipment
13 Precautions and warnings “after” the use of equipment
13 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
14 CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION
14 Additional procedures for reuse
14 Cleaning
14 Disinfection
15 Preventive Maintenance
15 Corrective Maintenance
16 UNFORESEEN EVENTS – SOLUTION OF PROBLEMS
16 EQUIPMENT’S WARRANTY
16 FINAL CONSIDERATIONS

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IDENTIFICATION OF EQUIPMENT
Dear Customer
Congratulations. You have made a good choice when you decided to buy a SAEVO 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.
IDENTIFICATION OF PRODUCT
Technical Name: Sealer
Trade Name: BioPack
Model: BioPack
Brand: Saevo

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Descrição do Equipamento
BioPack Sealer is designed for a hermetic sealing of surgical grade papers of all sizes on the market,
ensuring the sterility of items since sterilization until the moment of use.
Simple and safe operation because:
It has isolated resistance, which inhibits the risk of burning the paper, even when the paper is not
removed from the sealing region and does not transmit heat to the surface of product.
It allows temperature adjustment for fast and safe sealing for each type of paper.
It is provided with a trail type paper cutter, which cuts both ways, allowing cutting the paper in the
desired size with no need to pass the knife twice.
The sealer’s closing is performed by hand lever with lock, which enables better control of sealing time
and allows sealing the surgical grade paper without using both hands of the operator.
Its body is made of stainless steel, which prevents corrosion, has high mechanical resistance and it its
easy to clean and disinfect, besides providing a pleasing appearance.
It has a removable front support plate that makes the product more compact and easy to transport.
Physical principle used by the sealing equipment
Equipment for sealing surgical grade paper through bars at high temperature that are pressed on it
with the help of a lever, which provides a hermetic sealing, it is also equipped with a double-edged
blade that allows an easy way to cut both ways, after sealing.
Indication of Equipment
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
Every article to be sterilized must be carefully packed and sealed for a safe process, the BioPack
Sealer has the purpose of sealing packaging in an ecient and hermetic way to a perfect packaging.
IDENTIFICATION OF EQUIPMENT

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MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION
01 - Front Support plate;
02 - LED indicator;
03 - Power on/Power o switch;
04 - Power input cable;
05 - Operating lever;
06 - Lock;
07 - Knife handle;
08 - Temperature adjustment switch.
03
04
02
05
01
08
07
06
The materials used to produce the equipment are Biocompatible.
The use of any part, accessory or material not specied or provided in these instructions is of
entire responsibility of the user.
The contents of this page are of an informative nature, the equipment being able to dier
from that illustrated. So, upon acquiring the product check the technical compatibilty
between equipment, coupling and accessories.
a
a
side view

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TECHNICAL SPECIFICATIONS
Operation mode
Continuous
Power supply voltage
127V~: 110V~ - 140V~ / 220V~: 198V~ - 240V~
Frequency
50/60 Hz
Potency for resistance
127V~ / 220V~ = 250W
Power
570 VA (127 V) / 460 VA (220 V)
Rated current
2,1 A (220 V)
4,5 A (127 V)
Fuses
2,5 A (220 V)
5 A (127 V)
Sealing area
260mm
Width sealing
10mm
Support rollers (maximum length)
275mm
External housing
Stainless steel
Temperature (heating system)
The heating system can reach to 300Deg C maximum.
But we have installed temp. protector to limit the heating temp. at max. 220Deg C.
Net weight
6,40 Kg
Gross weight
8,26 Kg
General features

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Dimensions (mm)
TECHNICAL SPECIFICATIONS

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Packing symbols
Product symbols
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 avoiding humidity, rains
and wet oor
Packing to be transported and / or
stored with the harrows up
The packing must be stored and
transported away from direct sun
light exposure
Packing to be transported and / or
stored with care (should not suer
drop and neither receive impact)
Temperature limit for the packing
to be stored or transported
Turned o General sign for mandatory action
Attention:
Check the working instructions
Note:
It indicates useful information for
operation of the product
Refer to the instruction manual Turned on
Grounding (at several points of the
equipment) indicates the condition
of being grounded
General warning:
If the instructions are not properly
followed, the use can lead to
damage to the product, user or
patient
TECHNICAL SPECIFICATIONS

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INSTALLATION OF EQUIPMENT
- This equipment shall only be able to be unpacked and installed by a Saevo authorized technician,
under penalty of losing the warranty, as only (s)he has the information, suitable tools and training
required to execute this task.
- Saevo bears no responsibility for damages or accidents caused by poor installation executed by
a technician not authorized by Saevo.
- Only after the equipment has been installed and duly tested by the authorized technician
representing Saevo, will it be ready to start work operations.
The installation of this equipment requires the necessity of specialized technical assistance
(Saevo). Ask for the presence of a Saevo representative technician at the nearest seller,
or through the Saevo Service Center: + 55 (16) 3512-1212.
Moving parts installation
- Put the front support plate (01) into the Sealer, fitting the rip to thes upports (A).
- Fit the operating lever in the vertical position (05), on the sdie of the Sealer (B).
- Connect the Power input cable (04), to the connection behind the Sealer (C).
A B C

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EQUIPMENT OPERATION
Press the key (03) to power the equipment on, the LED indicator will light up (02).
Set the temperature adjustment switch (08) between ranges 3 and 4.
Put the surgical grade paper on the scroll bars, by positioning the locks (06) so as to better accommodate
it according to its size.
Wait until the LED indicator turns o, indicating that the Sealer has reached the selected temperature.
Pass the surgical grade paper behind and between the pressure and sealing bars, so that the paper siding
is upside down and the plastic siding is upwards.
Pull the surgical grade paper forward suciently to encapsulate the instruments.
Operate the lever (05) until it locks and hold it for approximately 4 seconds. Using the handle (07) quickly
pass the knife in the direction of the paper (the knife cuts in both sides), deactivate the lever (05) and
remove the surgical grade paper cut and sealed.
Place the instruments to be autoclaved inside the paper, which is now with a sealed side.
Place the other end (open) of surgical grade paper between the sealing bars and operate the lever
again (08) until it locks and hold for approximately 4 seconds, deactivate the lever.
In the rst sealing, check the quality of it, if necessary, adjust the temperature by using
the adjustment switch. After the adjustment, the same material can be sealed without
new adjustments.
The sealing bar operation temperature bar is very high. Watch out not to touch it directly.
To start the operation it is necessary to wait for the LED indicator to turn o, the LED will
turn o and on again during the operation, these signs can be ignored.

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PRECAUTIONS, RESTRICTIONS AND WARNINGS
Transportation, storage and operation
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;
Environmental condition for transportation or storage:
- Room temperature range for transportation or storage -29ºC to +60ºC.
- Relative humidity range for transportation or storage 20% to 90%.
- Atmospheric pressure range 500hPa to 1060 hPa (375 mmHg to 795 mmHg).
Environmental condition for storage (among the operations):
- Room temperature range for storage -10ºC a +55ºC.
- Recommended room temperature range +15ºC a +30ºC.
- Relative humidity range for storage 30% a 75%.
- Atmospheric pressure range 700 hPa to 1060 hPa (525 mmHg to 795 mmHg).
Environmental operation condition:
- Room temperature range for functioning +10ºC to +40ºC.
- Recommended room temperature range +21ºC to +26ºC.
- Relative humidity range for functioning 30% to 75%.
- Atmospheric pressure range 700 hPa to 1060 hPa (525 mmHg to 795 mmHg).
- Operation altitude: ≤2000m.
Attention
The Equipment maintains its condition of safety and e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.
Sensitivity to environmental conditions in normal situations of use
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.
Precaution and warnings “during the installation” of the equipment
- The equipment should only be installed by Saevo 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 the pressure, temperature, humidity,
direct sunlight, dust, salts.
- The equipment 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
inammable with air, or oxygen and nitrous oxide can be detected.

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Recommendations for preserving the equipment
Your Saevo 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.
- 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 Saevo Authorized Technical
Assistance.
Precautions and warnings “during the use” of equipment
- This equipment must be installed so that it is level.
- Check the voltage of the equipment at the moment of executing the electrical installation.
- Before the rst use and/or after long interruptions from work such as vacations, clean and
disinfect the equipment.
Saevo shall not be responsible for:
- Use of the equipment diering 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, diering from those described in these.
Instructions for use which come with the equipment or by the incorrect operation of it.
The sealing bar operation temperature bar is very high. Watch out not to touch it directly.
Precautions and warnings “after” the use of equipment
- Turn o 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.
Precautions and warnings during the “cleaning and disinfection” of equipment
- Before cleaning the equipment, turn o 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, etc.
PRECAUTIONS, RESTRICTIONS AND WARNINGS

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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
- 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 o the equipment, remove the power supply cable from the socket and contact your
representative (Saevo).
Precautions in case of alteration in the functioning of equipment
CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION
Cleaning
Important: In order to execute cleaning or any type of maintenance, ensure that the equipment is
disconnected from the electrical network.
Additional procedures for reuse
The equipment can be reused in undetermined, i.e. unlimited, quantities, only needing to be cleaned
and disinfected.
Attention
- In order to prevent risks and damages to equipment, make sure that the liquid does not
enter into the equipment.
- To cleaning the equipment, using the damp cloth with a mild soap. The application of
other solvent-based cleaning products or sodium hypochloride isn’t recommended, because
they may damage the equipment.
PRECAUTIONS, RESTRICTIONS AND WARNINGS
Disinfection
- Use clean and soft cloth dampened in alcohol 70% to disinfection of the equipment.
- Never use corrosive disinfectants or solvents.
WARNING
For preventing contamination, use gloves and other protection systems during disinfection.
Even that, during the procedures, gloves are used, after removing gloves the hands must
be washed out.

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CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION
Preventive Maintenance
The equipment must suer routinely measurements, following the current legislation of the country.
But, never with a period superior to 3 years.
For protecting your equipment, look for a Saevo’ technical assistance for periodic reviews as
preventive maintenances.
Attention
In case of the equipment presents any abnormality; check if the problem is related to some
of the listed items under the item Unpredictable (situation, cause and solution).
If it’s not possible to solve the problem, shutdown the equipment and demand the presence
of a Saevo’ technician from the nearest resale, or ask through the Attendance Service
Saevo: + 55 (16) 3512-1212.
Corrective Maintenance
Saevo states that the supplying of the circuits’ diagram, Part lists or any other information that
permits the technical assistance by the user, can be requested, since previously agreed between
the buyer and Saevo.
Replacement of fuses
Remove the power input cable (04) (D).
With the help of a screwdriver, release the fuseholder’s cover (E), afterwards replace the fuse.
WARNING: After replacing the fuses for the rst time, we recommend to reserve some fuses for
future replacements.
D E

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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
Imprevistos Provável Causa Soluções
Problem Probable cause Solution
- The equipment is not sealing. - Power input cable
disconnected;
- Switch turned o;
- Burned fuses;
-Bad adjustment of
temperature;
- Lack of pressure to the lever;
- Before the rst sealing, time
was not enough to reach the
adjusted temperature;
- Burned resistor.
- Connect the cable to the plug
- Check the voltage;
- Turn on the switch (03);
- Replace the fuses;
- Adjust the temperature on the
switch (08);
- When operating the lever, put
more pressure and hold it for
four seconds;
- When the Sealer is turned on,
before the rst sealing, wait
until the LED indicator turns o;
- Turn the equipment off
and contact the technical
assistance.
- Inappropriate cut. - Low speed while cutting;
- Knife does not cut anymore.
- Pull the knife’s handle quickly;
- Turn the equipment off
and contact the technical
assistance.
FINAL CONSIDERATIONS
Among the care you have to take with your equipment, the most important is regarding of the spare
parts replacement.
To ensure the lifetime of your device, only replace original spare parts from Saevo. They have the
assurance of the standards and technical specications required by the Saevo representative.
We call your attention to our authorized resellers’ chain. Only this chain will keep your equipment
constantly new, because it has trained technical assistant and specic tools for the correct
maintenance of your device.
Whenever you need, demand the presence of a Saevo’ technician from the nearest resale, or ask
through the Attendance Service Saevo: + 55 (16) 3512-1212.
EQUIPMENT’S WARRANTY
This equipment is covered by the warranty terms and norms contained in the Warranty Certicate
that accompany the product.

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