Vante 4105 User manual

Doc. No. 41050810-01 Rev D
INSTRUCTION
MANUAL
MODEL 4105
Hand-Held Sealing Head

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5/10 Vante®iii
Vante®
3480 E. Britannia Dr., Suite 120
Tucson, AZ 85706 USA
Telephone [phone]
Fax [phone]
Toll Free [phone]
Part No. 41050810-01 Rev. D

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Preliminary Information
Document Scope
This manual is intended as a guide for the operation, care and maintenance of the
Vante®Model 4105 Hand-Held Sealing Head. The information contained herein
is based upon technical data that have been validated by Vante®and is believed to
be appropriate for the intended use of the product.
Intended Audience
This manual is intended for use by personnel with technical skills and a thorough
understanding of the products, procedures, and safety requirements for processing
and handling of biopharmaceutical products.
Application
The Model 4105 Hand Held Sealing Head is part of a system and cannot be used
independently. When used in conjunction with a Vante®radio frequency (RF)
Power Source, it is the instrument used to make seals on tubing made of
RF-reactive thermoplastic materials typically used in biopharmaceutical
manufacturing. Tubing utilized in the handling of biopharmaceutical products are
typically made from thermoplastic vinyl, namely polyvinylchloride, (PVC) or
ethylene vinyl acetate (EVA), and it is this application for which this product is
specifically intended.
Exclusions and Limits of Liability
Vante®makes no warranties, expressed or implied, and assumes no liability in
connection with any use of this information. If the Sealing Head or its related
procedures are used for purposes other than those stipulated herein, validation of
the specific application should be obtained, otherwise Vante®assumes no liability
or obligation nor guarantees product performance. Personnel using the Sealing
Head do so at their own discretion and risk.

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Proprietary Information
All rights are reserved. Copying of the protected designs associated with the
Model 4105 Sealing Head is strictly prohibited without the prior written consent
of Vante®.
User Alerts
Throughout this document WARNINGS, CAUTIONS and NOTES are employed
to notify the user of important and/or critical information.
WARNING: A Warning indicates a condition or procedure that could result in
improper tube sealing or possible injury to the user. A Warning is
enclosed with a bold-line box.
CAUTION: A Caution indicates a condition or procedure that could result in
damage to the unit. A Caution is enclosed with a single-line box.
NOTE: A Note indicates important and/or useful information.
Safety Symbols
Caution, risk of electric shock
Caution
Protective Earth (P.E.)
Fuse
|On
Off
WEEE –Indicates electronic equipment requiring proper recycling
(EU only)
CE Mark Information
For inquires related to the CE marking of this product, please contact Vante®at
3480 E. Britannia Dr, Suite 120, Tucson, Arizona 85706 U.S.A., 520-881-6555,
520-323-9055 (fax).

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Table of Contents
Preliminary Information...........................................................................................v
Document Scope.............................................................................................v
Intended Audience ..........................................................................................v
Application......................................................................................................v
Exclusions and Limits of Liability..................................................................v
Proprietary Information................................................................................. vi
User Alerts .................................................................................................... vi
Safety Symbols.............................................................................................. vi
CE Mark Information.................................................................................... vi
Table of Contents......................................................................................... vii
Table of Figures..........................................................................................viii
Table of Tables ........................................................................................... viii
1. Sealing Head Description...................................................................................1
1.1 Product Overview ..................................................................................1
1.2 Theory of Operation...............................................................................1
1.3 Component Identification ......................................................................1
1.4 Environment...........................................................................................3
2. Sealing Head Operation .....................................................................................5
2.1 Setup ......................................................................................................5
2.2 Splash Guard Installation.......................................................................5
2.3 Sealing Procedure ..................................................................................7
2.4 Seal Spacing.........................................................................................10
3. Cleaning the Sealing Head...............................................................................11
3.1 Topical Cleaning of the Sealing Region ..............................................12
3.2 Disassembly of the Sealing Head.........................................................15
3.3 General Cleaning of the Sealing Head.................................................18
3.4 Reassembly of the Sealing Head..........................................................18
4. Repair...............................................................................................................23
4.1 Troubleshooting...................................................................................23
4.2 Spring Replacement.............................................................................24
4.3 Returning a Unit for Repair .................................................................25
5. Radio Frequency System Safety Considerations..............................................27
5.1 General Information.............................................................................27
5.2 RF Effects On Human Tissue ..............................................................27
5.3 RF Effects On Pacemakers ..................................................................27
5.4 Electrical Safety...................................................................................27
5.5 RF Effects On Electronic Equipment...................................................27
5.6 RF Effects In Potentially Explosive Atmospheres...............................28

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Table of Figures
Figure 1.1 Model 4105 Hand Held Sealing Head...................................................2
Figure 2.1 Tab and Sides A & B of Splash Guard..................................................5
Figure 2.2 Splash Guard Tab ..................................................................................6
Figure 2.3 Final Attachment of Splash Guard ........................................................6
Figure 2.4 Correct Technique for Holding the Sealing Head .................................7
Figure 2.5 Incorrect Technique for Holding the Sealing Head...............................8
Figure 2.6 Maintaining Compression During the Entire Sealing Process ..............8
Figure 2.7 Releasing the Sealing Head Lever at Seal Completion .........................9
Figure 3.1 Incorrect Cleaning Technique..............................................................11
Figure 3.2 Correct Lever/Sealing Body Gap.........................................................12
Figure 3.3 Cleaning the Sealing Region ...............................................................13
Figure 3.4 Drying the Sealing Region...................................................................13
Figure 3.5 Cleaning Ground and RF Jaw Surfaces...............................................14
Figure 3.6 Drying Ground and RF Jaw Surfaces ..................................................14
Figure 3.7 Releasing Spring Tension in Sealing Head .........................................16
Figure 3.8 Removing the Lever and Ground Jaw.................................................17
Figure 3.9 Sealing Head Components...................................................................17
Figure 3.10 Cleaning Individual Sealing Head Components................................18
Figure 3.11 Installation of Ground Jaw onto RF Jaw/Tube Assembly.................19
Figure 3.12 Installation of Lever on to Sealing Head...........................................19
Figure 3.13 Installation of Lever into Pivot Slots.................................................20
Figure 3.14 Final Assembly of Sealing Head .......................................................21
Table of Tables
Table 1.1 Sealing Head Component Functions................................................2

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1. Sealing Head Description
1.1 Product Overview
The Vante®Model 4105 Hand-Held Sealing Head (“the Sealing Head”) is part of a
system which employs radio frequency (RF) to make uniform, quality seals on a variety
of tubing sizes. A Vante®Power Source (Model 4380 or 4600) provides RF power to the
Sealing Head and controls RF power and sealing time. The manually-activated Sealing
Head forms a seal with its jaws in such a way as to make segment separation easy and
uniform. The Sealing Head is equipped with a splash guard for operator protection from
inadvertent contact with biopharmaceutical products in the unlikely event of tubing
rupture.
1.2 Theory of Operation
The physical properties of PVC plastic tubing (and other RF-reactive thermoplastic
materials) cause it to dielectrically heat at a molecular level in the presence of RF energy.
This energy causes the plastic to soften due to the friction of the vibrating molecules. In
this softened condition, the plastic becomes weldable because the molecules are free to
intermingle under the application of external forces, such as compression. If allowed to
cool while the forces are applied, the material will be permanently reshaped.
The Sealing Head receives a controlled amount of RF energy from the generator while
mechanically compressing the tubing across its diameter during the dielectric sealing and
forming process. When the energy is removed and the tubing is allowed to cool under
compression, a permanent seal is produced.
1.3 Component Identification
Table 1.1 indicates the function of each component included with the Sealing Head.

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Sealing Indicator Light
Serial Number
Splash Guard
RF Jaw
Ground Jaw
Lever
Assembly
Figure 1.1 Model 4105 Hand Held Sealing Head
Component
Function
Lever Assembly
Compresses the tubing between the jaws and activates the
sealing process.
RF Jaw
Compresses tubing with ground jaw while applying RF.
Ground Jaw
Grounds RF as it is applied and molds tubing.
Splash Guard
Attached to the lever of the Model 4105. Protects the
operator from accidental exposure to biopharmaceutical
products in the unlikely event of a tubing rupture.
Sealing Indicator
Light
Light on Sealing Head that indicates duration of RF power.
The Sealing Head jaws must remain closed until two seconds
after the indicator light turns completely off.
Serial Number
Indicates the serial number. Please make note of this
number when calling the Vante®Customer Service
Department.
Table 1.1 Sealing Head Component Functions

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1.4 Environment
The Sealing Head will perform effectively when used in a typical biopharmaceutical
processing facility or environment. Variations in actual environmental conditions of the
facility and/or the level of contamination and/or moisture on the ground and RF jaws
and/or tubing type, size and exterior may affect actual performance. Users are advised
that when temperature and humidity conditions seem less than what might be considered
comfortable for humans, it is best to slow the rate of repetitive sealing, to be certain the
Sealing Head and tubing are clean and dry, and to frequently check the quality of seal
being produced.
Mechanical
Dimensions (Lever compressed): 8.0 in. L x 1.5 in. W x 1.0in. H
(20.3cm L x 3.8cm W x 2.5cm H)
Operating weight 0.6 lb
(0.3 kg)
Shipping weight (Boxed system): 2.0 lb
(0.9 kg)

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2. Sealing Head Operation
2.1 Setup
Remove the components from their protective shipping containers and visually inspect
them for obvious damage. Contact an authorized Vante®service center if any damage is
found.
NOTE: If possible, retain shipping containers and packing materials for future use.
2.2 Splash Guard Installation
NOTE: The Sealing Head assembly comes with a clear plastic splash guard to provide
operator protection in the event of a tubing rupture during sealing. Extra splash
guards are provided with each shipment and are available for purchase from
Vante.®
Ensure the RF power cable is disconnected from the Sealing Head.
WARNING: Failure to separate the Sealing Head from the power source prior to removing or
attaching the splash guard may result in an RF burn.
Fold tab and sides A & B at perforations of the new splash guard. Remove plastic cutout
opposite of tab and discard. See Figure 2.1.
TAB
A
B
Figure 2.1 Tab and Sides A & B of Splash Guard
Close lever and place around head of sealer. Insert tab into the splash guard opening on
opposite side. See Figure 2.2.

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Figure 2.2 Splash Guard Tab
Position splash guard so sides of lever protrude through openings. Bend end of tab to
lock into position.
Splash Guard
Figure 2.3 Final Attachment of Splash Guard
See the Generator Instruction Manual for proper setup.

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2.3 Sealing Procedure
For sealing and segmenting tubing, hold the Sealing Head in the palm of either hand with
the fingers on the moveable lever so that the splash guard and sealing indicator light face
the operator, as shown in Figure 2.4. In this position, the tubing can be easily placed into
the space (“sealing region”) between the RF and ground jaws, sealed, and pushed through
the region to the next sealing position by the operator's free hand.
WARNING: The sealing region must open facing upward so the operator may ensure that the
tubing or bag is fully seated between the RF jaw and ground jaw and clearly
observe the sealing indicator lamp on the Sealing Head.
WARNING: Do NOT pull the tubing or bag through the sealing region. Under no
circumstances should the tubing be pulled at the instant of sealing. An opening in
the tubing could occur which will subject the product or media to non-sterile
conditions and the user to potentially hazardous fluids. In addition, the Sealing
Head may become damaged by arcing caused by contamination of the sealing
region.
Magnet
Figure 2.4 Correct Technique for Holding the Sealing Head

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WARNING: Do not place fingers in close proximity to the sealing region while sealing. Doing
so will subject the operator to a radio frequency burn hazard and will not allow for
good magnet-Sealing Head body contact, resulting in poor or ruptured seals.
Figure 2.5 Incorrect Technique for Holding the Sealing Head
To make a seal, squeeze the lever until the magnet on the lever touches the Sealing Head
body, and hold it there (Figure 2.6). This action compresses the tubing and activates the
sealing energy, visually indicated by the illumination of the sealing indicator light.
Continue to squeeze the lever for two seconds after the sealing indicator light goes
completely out.
WARNING: Dimming of the indicator light will occur, but do not release the lever until two
seconds after the indicator light is completely off! Premature lever release will
cause incomplete sealing and/or ruptured tubing. Holding the lever closed will not
cause overheating or burn-through of the tubing.
Figure 2.6 Maintaining Compression During the Entire Sealing Process

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CAUTION: Never squeeze the lever when non RF-reactive materials are in the sealing region,
or if the RF power source is not connected and turned on. Damage to the lever
and poor Sealing Head operation may result.
Although RF remains on for approximately one second, as indicated when the light on the
Sealing Head goes out, the lever should not be released until two seconds after the RF
light goes out. Another seal cannot be made until the moveable lever has been fully
opened. See Figure 2.7. At this time the tubing segments can be easily separated by
manually turning and pulling with a slight snap.
Figure 2.7 Releasing the Sealing Head Lever at Seal Completion
NOTE: Seals on large tubing may require an additional lever hold down time after the
indicator light goes out to ensure formation of the best seal.
WARNING: Under no circumstances should the tubing or bag be separated by pulling it while
the indicator light is illuminated. This action may cause an opening in the tubing,
which will subject the product or media to non-sterile conditions and the user to
potentially hazardous fluids. In addition, the Sealing Head may become damaged
by arcing due to contamination of the sealing region.
WARNING: If you observe arcing while making a seal, follow the instructions in the
Troubleshooting Guide under “Arcing or Bad Seals”. Although a seal made when
you experience arcing may look acceptable, it may be inadequate. Take
precautions as if this is an inadequate seal.

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2.4 Seal Spacing
NOTE: The Sealer is designed to allow repetitive seals to be made on a length of tubing
filled with biopharmaceutical products. However, several factors control how
closely the seals may be spaced.
General Guidelines
Seals which progress along an open-ended length of tubing may be spaced as
desired, but ½ inch (1 cm) is the recommended minimum.
Seals which progress along a close-ended length of tubing, as in a segmenting
process, must be spaced approximately one inch (2.5 cm) to avoid rupture of the
tubing due to pressure build-up.
WARNING: Never attempt to make segmentation seals closer than recommended without
validating for seal integrity.
WARNING: Multiple seals spaced less than the recommended distance may cause a rupture of
a sealed tubing segment.

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3. Cleaning the Sealing Head
WARNING: To obtain satisfactory seals at all times, be sure the sealing region and all adjacent
areas are always kept clean and dry.
CAUTION: Do NOT, under any circumstances, submerge the Sealing Head in any kind of
liquid. This will damage the RF jaw/tube assembly and void the warranty.
Figure 3.1 Incorrect Cleaning Technique
NOTE: Other than periodic cleaning or when moisture or other contaminants are visible,
the Sealing Head is designed to be maintenance free and to withstand substantial
wear and tear. However, damage may occur as a result of dropping any of the
major components, i.e., the Sealing Head or the power source. If any component
is dropped, examine for obvious damage and confirm functionality before using.
Verify the movement of the ground jaw while squeezing the lever. The RF jaw
and ground jaw should just touch with approximately 1/8 inch gap between the
lever magnet and the Sealing Head body (see Figure 3.2). Contact Vante®if the
Sealing Head fails to operate properly.

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Figure 3.2 Correct Lever/Sealing Body Gap
3.1 Topical Cleaning of the Sealing Region
NOTE: Units returned to Vante®for repair are subject to biohazard charges if any Sealing
Head component is contaminated with biopharmaceutical products. See the
beginning of this chapter for the recommended cleaning.
WARNING: Topical cleaning of the Sealing Head is performed in this section using denatured
or isopropyl alcohol. The user should follow the alcohol manufacturer’s
recommendations for usage and be sure that the product material safety data sheet
is carefully understood and observed.
NOTE: The illustrations in this section show the splash guard removed for clarity.
However, to perform a topical cleaning, it is not necessary to remove the splash
guard.
Disconnect the Sealing Head from the power source by removing the RF power cable at
the Sealing Head.
WARNING: Failure to separate the Sealing Head from the generator prior to cleaning may
result in an RF burn to the operator during the cleaning process.
Hold the Sealing Head with the sealing region upward thereby exposing the space
between the ground and RF jaws.
Clean the open sealing region with alcohol (denatured or isopropyl) applied to one end of
a cotton swab, as shown in Figure 3.3. Be sure the RF power cable is disconnected from
the Sealing Head!