SAEVO BioSeal User manual

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MANUAL PRESENTATION
Trade Name: Sealer
Model: BioSeal
Brand: Saevo
ZHEJIANG FOMOS MEDICAL TECHNOLOGY CO.,LTD.
No.205 Guangyuan Road Jiangbei District Ningbo 315033 CHINA
Phone:[phone] Fax:[phone]
77000001691 - Rev.: 00 - July/22
Importer/Distributor
Alliage S/A Indústrias Médico Odontológica
Rodovia Abrão Assed, Km 53 + 450m - CEP 14097-500
Ribeirão Preto - SP - Brasil
Phone: [phone]

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TRADEMARKS
All terms mentioned in this manual are well-known trademarks, registered trademarks or service
marks that have been properly labeled as such. Other products, services, or terms mentioned in
this manual may be trademarks, registered trademarks, or service marks of their respective holders.
Alliage S/A does not make any claim to these brands. The use of a term in this manual should not
be construed as inuencing the validity of any trademark, registered trademark, or service mark.
Saevo and BioSeal are trademarks registered by Alliage S/A.
Copyright © 2021 Alliage S/A. All rights reserved

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SUMMARY
01 GENERAL INFORMATION 07
1.1. DEAR CUSTOMER 07
1.2. INDICATIONS FOR USE 07
1.3. CONTRAINDICATIONS 07
1.4. SYMBOLOGY 08
02 WARNINGS, CAUTIONS AND RECOMMENDATIONS 10
03 GENERAL SYSTEM DESCRIPTION 14
3.1. SYSTEM DESCRIPTION 14
3.2. OPERATION PRINCIPLES 14
3.2.1. User prole 14
3.3. PRODUCT MAIN COMPONENTS 15
3.3.1. Parts included with the product 15
04 INSTALLATION 17
4.1. GENERAL PRECAUTIONS 17
4.2. ELECTRICAL CONNECTION 17
4.3. PRODUCT PREPARATION 17
4.4. SURGICAL GRADE PAPER REEL INSTALLATION 18
05 OPERATION 20
5.1. PREPARATION 20
5.2. PAPER LOADING 20
5.3. SEALING AND CUTTING 20
5.4. FINISHING 21
06 CLEANING 23
6.1. GENERAL CLEANING 23
07 TROUBLESHOOTING, INSPECTION AND MAINTENANCE 25
7.1. WARNING SIGNAL TO THE OPERATOR 25
7.2. PROBLEM SOLVING 26
7.3. PERIODIC INSPECTION 27
7.4. PREVENTIVE MAINTENANCE 27
7.5. CORRECTIVE MAINTENANCE 28
7.6. BLADE REPLACEMENT 28
7.7. FUSES REPLACEMENT 28
08 TECHNICAL SPECIFICATIONS 30
8.1. DEVICE INFORMATION 30
8.2. SAFETY DEVICES 30
9 WARRANTY 33
10 ALLIAGE AUTHORIZED SERVICES 35

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Alliage S/A Indústrias Médico Odontológica
Phone: [phone]
Highway Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil
1
GENERAL INFORMATION

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1. GENERAL INFORMATION
1.1. DEAR CUSTOMER
Congratulations for your excellent choice. By purchasing ALLIAGE quality equipment, you can be
sure of purchasing products with technology compatible with the world's best in its class. This
manual oers you a general description of your equipment, describing important details that can
guide you in its correct use, as well as in the solution of small problems that may eventually occur.
You should read this manual completely and keep it for future reference.
1.2. INDICATIONS FOR USE
This equipment must be used and handled by a qualied person (professional duly accredited, in
accordance with the local legislation of the country) observing the instructions contained in this
manual. It is the user's obligation to use the equipment only in perfect condition and to protect
himself, patients and third parties against possible risks.
1.3. CONTRAINDICATIONS
None known so far.

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1.4. SYMBOLOGY
The following symbols are used in this manual and on the product. Make sure you fully
understand each symbol and follow the instructions go together.
Fragile, handle with care Maximum Stack
Protect from the rain This side Up
Manufacturer Manufacturing date
General warning Attention
Model number Serial number
Model Catalog number
Indicates that the product must
be taken to a special waste
collection point at the end of
its working life. It applies to the
equipment and its accessories.
Mandatory action
Use instructions High temperature

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Alliage S/A Indústrias Médico Odontológica
Phone: [phone]
Highway Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil
2
WARNINGS, CAUTIONS AND RECOMMENDATIONS

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General warnings
2. WARNINGS, CAUTIONS AND RECOMMENDATIONS
Read and understand all instructions contained in these instructions for use
before installing or operating this equipment.
Only use the equipment in perfect conditions and protect yourself, patients
and third parties against possible dangers.
This equipment must be installed and operated by personnel familiar with all
necessary precautions.
• Do not spill liquids on the body of the equipment.
• Never operate the equipment in a humid environment.
• Use the equipment only with the supplied accessories.
• Do not make changes to the equipment or open its compartments.
General prohibition indication. The functionality of the system can be destroyed
in the case of incorrect use. If unauthorized alterations have been made to the
system and the supplied accessories, the Manufacturer's warranty will be void.
Alliage will not accept any responsibility for product malfunction in this case.
If one of the following conditions occurs, disconnect the equipment from the power supply and
contact the authorized technical service:
• The power cord or power adapter are damaged.
• The equipment was exposed to water.
• The equipment was damaged.
• The equipment does not work properly when the Operating Instructions are followed.
There is a risk of electric shock when opening or attempting to open any part of
the system; Only authorized technical service should open parts of the system.

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While transporting
The equipment must be transported and stored, observing the following:
• Handle with care to avoid falls, excessive vibrations and impacts;
• The arrows on the packaging must be pointing up;
• Do not stack more than the amount indicated on the packaging;
• Protect against sunlight, humidity, water and dust;
To help ensure proper hygiene and protect against infectious diseases, prior to rst use, the equipment
must be cleaned and disinfected following the Instructions contained in this manual.
Before using the equipment
During equipment installation
• Put the equipment in a place where it will not be in contact with moisture or water.
• Install the equipment in a place where it will not be damaged by pressure, temperature, humidity,
direct sunlight, dust, salts or corrosive products.
• The equipment must not be subjected to excessive vibration or shock (including while transporting
and handling).
• This equipment is not designed for use in the presence of vapors from ammable anesthetic
mixtures or nitrous oxide.
• Recommendations must be followed.
During equipment use
• To operate the equipment, the operating personnel must:
- Read and understand the user manual.
- Be familiar with the structure and fundamental functions of this equipment.
- Be able to recognize irregularities in the operation of the equipment and implement the appropriate
measures, when necessary.
• If this product is exposed to water, moisture, or foreign substances, turn it o immediately and
contact an Alliage Authorized Service Center.
• In case of damage or defect, do not use the equipment and contact an Alliage Authorized Service
Center.
• Do not use or equipment if any of its compartments or parts are damaged, lose or have been
removed. Contact an Alliage Authorized Service Center and have any damaged, loose, or removed
cabinets or parts repaired or replaced before returning to use. Do not touch or use the equipment
if it is being repaired or if the equipment cabinets have been removed.
• Do not open or remove any of the cabinets in the set. No internal parts are user serviceable. The
operator cannot use tools to open the equipment.

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After using/operating the equipment
• Disconnect the equipment if it is not in use for a long time.
• Execute cleaning and disinfection according to the Instructions contained in this manual.
• Do not disconnect the cable or other connections if unnecessary.
• No modication to this equipment is allowed.
Precautions in case of alterations in the operation of the equipment
If the equipment shows any abnormality, check if the problem is related to an item listed in the
topic “Problem Diagnosis” of this user manual.
If it is not possible to solve the problem, disconnection or equipment, contact an Authorized Alliage
Technical Assistance.
The Manufacturer is NOT responsible:
• That the equipment is used for other purposes than those for which it was
conceived.
• For any damages caused to the equipment or operator, as a result of incorrect
installation and Maintenance procedures in disagreement with the Operating
Instructions that accompany the equipment.
Precautions in case of equipment deactivation
To avoid environmental contamination or improper use of the equipment, when or even unused,
these must be discarded (according to current legislation) in an appropriate place, because the
materials existing inside can contaminate the environment.
For the European Economic Area (EEE), this product is subject to Directive 2012/19/EU, as well as
the corresponding national laws. This directive requires that the product must be taken to a special
collection site at the end of its useful life. Applies to both equipment and accessories.
Contact the reseller for nal disposition of the product if necessary.
This equipment should not be eliminated as domestic waste.

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Alliage S/A Indústrias Médico Odontológica
Phone: [phone]
Highway Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil
3
GENERAL SYSTEM DESCRIPTION

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3. GENERAL SYSTEM DESCRIPTION
3.1. SYSTEM DESCRIPTION
The BioSeal Sealer was designed for hermetic sealing of surgical grade papers, guaranteeing
the sterility of two items from sterilization to the moment of use.
The BioSeal Sealer is an electronically controlled heat sealer with a sealing range of 12 mm,
suitable to withstand the sterilization processes of modern sterilizers with pre-vacuum fractionation
and to guarantee the sterility of the packaging on time.
Ecient heat control in the sealing area is achieved thanks to automatic temperature
adjustment, guaranteeing high and constant performance.
The solid structure in plastic and aluminum and the ergonomic shape help to maintain a high
level of hygiene and excellent stability during use.
Looking forward to the goal of oering a product suitable for the daily needs of the medical-dental
area.
3.2. OPERATION PRINCIPLES
Equipment for sealing surgical grade paper by means of bars at high temperature that are
pressed on it with the help of a lever, or that provides an airtight seal. Also equipped with a sheet
of two gums that, in addition to sealing, makes it possible to cut easily in both directions.
Unintentional use of the system may result in physical injury to the patient
and operator and damage to the system.
3.2.1. User prole
The BioSeal Sealant can be used by both sexes, with a minimum level of literacy with the
ability to read and understand images, symbols, icons, western characters (Arial font), alphanumeric
characters, not being able to present a degree of visual imperfection for Reading or vision and
degree of commitment from recent memory, not being in a clear capacity to execute the activities
and functions of the product in a professionally correct manner.

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3.3. PRODUCT MAIN COMPONENTS
3.3.1. Parts included with the product
01 - Surgical grade paper roll
02 - Cutting handle
03 - Warning LED
04 - Operation panel
05 - ON/O Key
06 - Power cable outlet
07 - Sealing handle
08 - Support handle
09 - Surgical grade paper support
10 - Reel Splitter
01
02
10
09
08
03
04
05
07
06

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4
INSTALLATION
Alliage S/A Indústrias Médico Odontológica
Phone: [phone]
Highway Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil

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4. INSTALLATION
4.1. GENERAL PRECAUTIONS
The technical service is at your disposal to clarify any doubts or provide more
information.
The electrical installation must be supplied with an earth connection.
- Install the Sealer on a at surface, leaving enough space for its operation and adequate ventilation;
- Make sure that the surface is strong or sucient to support the unit and the weight of the coil;
- Do not install next to sinks to avoid contact with water or liquids that could cause short circuits
or potentially dangerous situations for the operator;
- Do not install in humid or poorly ventilated environments;
- Do not install in an environment with the presence of ammable and/or explosive gases or vapors;
- Install the unit in such a way that the power cable is not bent or pressed along its path to the outlet.
4.2. ELECTRICAL CONNECTION
In accordance with the regulations in force, the unit must be connected to a socket of the electrical
installation with adequate power for the consumption of the unit and grounded.
4.3. PRODUCT PREPARATION
1) Carefully remove the contents of the packaging.

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2) Insert the operation panel in appropriate space. Next, pull backwards the support handles until
they reach the table.
3) Insert the paper holder into the handles, checking that the holes at the end of the tube t
correctly into the slots on the handles.
4.4. SURGICAL GRADE PAPER REEL INSTALLATION
- Insert the coil into the surgical grade paper holder.
- Install the surgical grade paper support on the support handles (as described in the previous
paragraph), positioned so that the paper mat unrolls downwards and with the polypropylene lm
upwards. Then tighten the bobbin splitter.
If you need installation assistance, contact Alliage Authorized Technical
Support.
Phone: [phone]
Address: Highway Abrão Assed, Km 53 + 450m - Recreio Anhanguera –
Ribeirão Preto-SP/ Brasil CEP 14097-500

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Alliage S/A Indústrias Médico Odontológica
Phone: [phone]
Highway Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil
5
OPERATION

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5. OPERATION
5.1. PREPARATION
- Check if the sealing handle is positioned at the highest end of the guide. Turn on the Sealer with
the Switch located on the lower right side.
- The front green LED will ash, it means Sealer preheating.
- The heating resistance is energized, and its temperature will gradually increase. Upon reaching
the ideal level for a proper seal, the front green LED remains on continuously.
5.2. PAPER LOADING
- Pass the surgical grade paper behind and between the pressure and sealing bars, so that the
paper side is down, and the plastic side is up, if necessary, you can measure the size before sealing
and cutting
5.3. SEALING AND CUTTING
- Lower the sealing handle from position 1 to position 2.
- The green LED will ash rapidly until the end of sealing, indicated by an acoustic signal.
- Slide the cutter handle to the opposite end.
- Raise the sealing handle from position 2 to the original position 1.
- The front LED will light up green continuously and the acoustic signal will turn o. The paper is
now sealed at one end.
01
02