Vante 4600 User manual

Doc. No. 46000810-01 Rev. D
INSTRUCTION
MANUAL
MODEL 4600
RF Tube Sealer Power Source

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9/12 Vante®iii
Vante®
3480 E. Britannia Dr., Suite 120
Tucson, AZ 85706 USA
Telephone [phone]
Fax [phone]
Toll Free [phone]
Part No. 46000810-01 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 4600 RF Tube Sealer Power Source (hereinafter referred to as “the Power
Source”). The information contained herein is based upon technical data that has 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 having technical skills and a thorough
understanding of the procedures for using radio frequency (RF) power to seal, form
and/or weld RF reactive thermoplastic materials who understand that this product is to be
used at their own discretion and risk.
Application
The Model 4600 RF Power Source is a part of a system and cannot be used
independently. When used in conjunction with Model 4605 & 4105 sealings heads it is
the Power Source used to make seals on tubing made of RF-reactive thermoplastic
materials typically used in biopharmaceutical manufacturing. Tubing utilized in the
manufacture of biopharmaceuticals is typically made from thermoplastic vinyl, namely
polyvinylchloride (PVC) and ethyl vinyl acetate (EVA), this device has been tested and it
is intended to be used with PVC tubing only.
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 Power Source 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 Power Source do so at their own discretion and
risk.
Vante shall have no liability for consequential, incidental, or exemplary damages of any
description in connection with the products.

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Proprietary Information
All rights are reserved. Copying of the protected designs associated with the Model 4600
Power Source 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.)
Caution, Hot Surface
Fuse
| On
OOff
WEEE –Indicates electronic equipment requiring proper recycling (EU only)

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Regulatory Compliance Information
The Model 4600 RF Tube Sealer meets following directives:
Electromagnetic Compatibility Directive –89/336/EEC
Low Voltage Directive –73/23/EEC (as amended by 93/66/EEC)
Conformity Assessment Body: TUV SUD America.
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. [phone], +1-520-323-
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
Regulatory Compliance Information ........................................................... vii
Table of Contents.......................................................................................... ix
Table of Figures..............................................................................................x
Table of Tables ............................................................................................. xi
1. Power Source Description..................................................................................1
1.1 Product Overview ..................................................................................1
1.2 Theory of Operation...............................................................................1
1.3 Component Identification ......................................................................2
1.4 Operating Environment..........................................................................5
1.5 Tubing Specifications ............................................................................5
1.6 Seal Cycle ..............................................................................................6
1.7 Specifications.........................................................................................6
2. Power Source Operation....................................................................................7
2.1 Setup ......................................................................................................7
2.2 Sealing Procedure with Model 4105 Hand Held Sealing Head.............8
2.3 Sealing Procedure with Model 4605 Bench Top Sealing Head...........11
2.4 Seal Spacing.........................................................................................14
3. Maintenance.....................................................................................................15
3.1 Cleaning Power Source Case...............................................................15
3.2 Troubleshooting...................................................................................16
4. Failure Isolation...............................................................................................17
4.1 Failure Isolation...................................................................................17
4.2 Fuse Replacement................................................................................17
4.3 Repair...................................................................................................18
5. Radio Frequency System Safety Considerations.............................................21
5.1 General Information.............................................................................21
5.2 RF Effects On Human Tissue..............................................................21
5.3 RF Effects On Pacemakers ..................................................................21
5.4 Electrical Safety...................................................................................21
5.5 RF Effects On Electronic Equipment ..................................................21
5.6 RF Effects in Potentially Explosive Atmospheres...............................21

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Table of Figures
Figure 1.1 RF Tube Sealer with Hand Held and Bench Top Sealing Heads..........1
Figure 1.2 Model 4600 RF Tube Sealer Components ............................................2
Figure 1.3 RF Power Source Power Interface Panel...............................................4
Figure 1.4 Serial Plate and Fuse/Rating Labels for Power Source.........................4
Figure 2.1 RF Power Cable Attachment (For Use with a Model 4105).................7
Figure 2.2 Model 4605 Bench Top Sealing Head Cable Attachment.....................8
Figure 2.3 Correct Technique for Holding the Sealing Head.................................8
Figure 2.4 Incorrect Technique for Holding the Sealing Head...............................9
Figure 2.5 Maintaining Compression During the Entire Sealing Process ..............9
Figure 2.6 Releasing the Sealing Head Lever at Seal Completion.......................10
Figure 2.7 Correct Sealing Method.......................................................................11
Figure 2.8 Incorrect Sealing Method ....................................................................12
Figure 2.9 Repeating the Seal Process..................................................................13
Figure 2.10 Multiple Seal Spacing........................................................................14
Figure 4.1 Releasing Fuse Holder Latch...............................................................18

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Table of Tables
Table 1.1 Tube Sealer Component Functions.........................................................3
Table 1.2 Tubing Specifications.............................................................................5
Table 3.1 Troubleshooting Guide.........................................................................16

Vante® Model 4600
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1. Power Source Description
1.1 Product Overview
The Vante Model 4600 RF Tube Sealer is a compact, portable device which employs
radio frequency (RF) to make uniform, quality seals on a variety of tubing sizes without
power adjustment by the user. The System consists of the Model 4600 Power Source
(“the Power Source”) and can be teamed with either the Model 4105 hand-held,
manually-activated sealing head or the Model 4605 bench-top segmenting sealing head
(“the Sealing Head”) which creates a seal that is formed by the sealing head jaws in such
a way as to make segment separation easy and uniform.
Figure 1.1 RF Tube Sealer with Hand Held and Bench Top Sealing Heads
1.2 Theory of Operation
The physical properties of PVC and EVA 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 sealable 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 Power Source is an instrument that, when actuated, generates a controlled amount of
RF energy at the sealing head 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.
The Power Source produces a minimum of 150 Watts of RF power, the frequency of
which is controlled by a solid-state oscillator/amplifier operating at 40.68 MHz. The RF
energy level and seal time are controlled by means of a proprietary solid-state circuit

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design, allowing various tubing sizes to be automatically accommodated. The Power
Source requires no manual power or timing adjustment by the user.
1.3 Component Identification
The Model 4600 Power Source, when coupled with the various sealing heads, becomes a
system. Figure 1.2 shows the component parts of the sealing system with a Hand Held
Sealing Head and a Bench Top Sealing Head. Table 1.1 indicates the function of each
component.
RF
Ground
Jaw
Model 2605
Sealing Head
Five Pin Connector
RF Power Cable
Splash
Guards
Figure 1.2 Model 4600 RF Tube Sealer Components
Model 4605
Bench Top
Sealing Head
RF Power Source
Model 4105
Sealing Head

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Component
Function
Model 4600 RF Power
Source
Provides RF power to the sealing head. Automatically controls RF power and
sealing time.
RF Ready Light
LED located on the front of the unit labeled "READY". Illuminates when RF
power is ready.
Model 4105 Hand Held
Sealing Head
Hand-held, manually-activated unit consisting of the RF jaw/tube assembly,
ground jaw and lever. Compresses tubing between the RF and ground jaws
while Power Source applies RF energy.
Model 4605 Bench Top
Sealing Head
Bench-top, automatically activated unit consisting of the RF jaw, ground jaw
and seal trigger and RF power cables. It automatically performs the sealing
operation when the seal trigger is activated.
Sealing Indicator Light
Light on sealing head which indicates duration of RF power. For the Model
4105 the sealing head jaws must remain closed until two seconds after
indicator light turns completely off.
AC Power Cord
Detachable AC power cord. Plug end varies with country in which Power
Source is used to provide AC power connection to the country-specific AC
Power Source.
Model 1103 RF Power
Cable
Connects the Model 4105 Sealing Head to the Power Source at the RF power
output connector located on the front of the unit.
Model 4605 Cables
Connects the Model 4605 Sealing Head to the Power Source with an RF
connector and a DC connector.
Power Input Receptacle
and Fuse Holder
Located on the rear of the Power Source. Connects the Power Source to
detachable AC power cord and houses the user-replaceable fuse.
AC Power Switch
Turns AC power "on" or "off". Rocker-type switch located on the rear of the
Power Source, labeled "Power Switch". Illuminates to indicate that the power
supply is connected to AC power.
RF Power Output
Female BNC connector providing RF power to the sealing head.
Serial Plate
Indicates the model number, the serial number, the fuse information and the
required power input of the Power Source. Located on the back of the unit.
Table 1.1 Tube Sealer Component Functions
Shown in Figure 1.3 is the power interface panel located on the back of the Power Source.
Figure 1.4 depicts the serial plate and fuse/rating label which specifies the power input
requirements for the Power Source. Each unit's serial plate (located on the rear of the
unit) indicates the model and serial number of the unit. Refer to the serial number when
contacting Vante™or one of its authorized service centers.

Vante® Model 4600
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US.PAT NOS 280515,
4488028, 4496819,
4529859, 5349166
Figure 1.3 RF Power Source Power Interface Panel
Figure 1.4 Serial Plate and Fuse/Rating Labels for Power Source
CAUTION: Unit is equipped with dual fuses. Disconnect power cord before replacing
fuses.
RF Power
Output
RF Ready
Light
Serial Tag
Fuse Holder
Power Switch
Power Input
Receptacle
DC Output

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1.4 Operating Environment
The Power Source will perform effectively when used in a typical biopharmaceutical
manufacturing environment. Variations in tubing type and size, processing media, actual
environmental conditions of the facility and/or the level of contamination and/or moisture
on the ground and RF jaws and/or tubing 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.
The Power Source and Sealing Head should be stored between 10.0and 122F (-12 to
50c). To ensure optimal performance, it is recommended that the Sealer be acclimated
to the ambient environmental operating temperature for approximately one hour prior to
use.
1.5 Tubing Specifications
Table 1.2 illustrates typical tubing sizes found in the biopharmaceutical industry. The
table also represents those tubing sizes validated at Vante. It is not intended to absolutely
define operating performance characteristics. Allowances are made for dimensions and
tolerances that fall outside of these typical tubing sizes. Users may verify sealer function
and performance on tubing sizes not included here.
Sealing
Head
Model
Description
Tubing
Size
Outside Diameter
Wall Thickness
4105
Hand-held Sealing Head
Small
0.080-0.147 inch
(2.0-3.7 mm)
0.020-0.030 inch
(0.5-0.8 mm)
Medium
0.148-0.179 inch
(3.8-4.5 mm)
0.020-0.035 inch
(0.5-0.89 mm)
Large
0.180-0.260 inch
(4.6-6.6 mm)
0.030-0.040 inch
(0.8-1.0 mm)
4605
Bench-top Segmenting
Head
Small
0.080 –0.18 inch
(2.0 –4.6 mm)
0.020 –0.037 inch
(0.5 - .94 mm)
Table 1.2 Tubing Specifications

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1.6 Seal Cycle
The Sealer “seal cycle” (or duty cycle) is defined as the time period, in seconds, between
consecutive, repetitive seals. The maximum seal cycle and hourly rate will vary with
different types and sizes of tubing, processing media and environmental conditions of the
facility. Operating the Sealer as fast as it allows is acceptable, however, if continuously
sealing, the Sealer may automatically shut down to avoid overheating. The green “seal
ready” light will remain illuminated but seals cannot be made. If this occurs, leave the
power on so the fan will continue to run. Allow five minutes for cooling, ensure the
green seal ready light is on, and resume sealing.
1.7 Specifications
Mechanical
Dimensions
Power Source: 10.5 L x 4.4 W x 7.1 H in.
(26.7 x 11.1 x 18.1 cm)
Operating weight
Power Source with cord: 9.6 lb (4.4 kg)
Hand Held Sealing head: 0.6 lb (0.3 kg)
Bench Top Sealing head: 5 lbs (2.3 kg)
Electrical
Power input 100-120/230 VAC, 50/60 Hz
Current draw 6.3A /4A INTERMITTENT
Mains AC power fuse 250VAC, 5x20mm T6.3A/T4A INTERMITTENT
RF power output 150 watts min into matched 50load, at power-up
Primary frequency 40.68±0.02 MHz
Environmental Conditions
Installation Category I
Pollution Degree 2
4º-38ºC at 90 percent maximum relative humidity, non-condensing.
Altitude tested up to 2000 m.

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2. Power Source 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. If possible, retain shipping containers and packing materials for future use.
Connect the AC power cord to the power input receptacle located on the rear of the
Power Source. Refer to the voltage/fuse plate located on the back of the unit to
determine the appropriate AC power input. The Power Source must be 100, 120 or 230
VAC, 50/60 Hz as indicated on the rating plate.
NOTE: Check to see that the power cord plug matches the power receptacle for
the country in which the Power Source is being used. If it does not,
contact an authorized Vante service center.
Place the Power Source on a desk or lab counter for convenient use and route the AC
power cord to prevent interference with other equipment or activities. Verify the AC
power switch is in the ""(off) position and connect the AC power cord to the AC
power receptacle.
When using the Power Source with a Hand Held Sealing Head, attach one end of the RF
power cable to the Power Source and the other end to the sealing head. Connect the cable
by pushing the connectors together and rotating clockwise until locked (see Figure 2.1).
Model 4600
Model 4105
Sealing Head
Figure 2.1 RF Power Cable Attachment (For Use with a Model 4105)
CAUTION: Do NOT attempt to use any other length or type of RF power cable.
Unauthorized substitution of the RF power cable may result in
malfunction of the Power Source and will void the warranty!
When using the Bench Top Sealing Head, connect the BNC connector end of the Bench
Top Sealing Head to the RF output on the back of the Power Source. Rotate the

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connector clockwise to lock it in place. Plug the seven-pin connector into the DC output.
See Figure 2.2.
Figure 2.2 Model 4605 Bench Top Sealing Head Cable Attachment
CAUTION: Do NOT attempt to use any other length or type of RF power cable.
Unauthorized substitution of the RF power cable may result in
malfunction of the Power Source and will void the warranty!
Place the Bench Top Sealing Head in a convenient location, allowing clear access to the
head and routing the cable so that it does not interfere with other activities.
Turn on the unit by pushing the rocker-type power switch on the rear of the Power Source
to the "|"(on) position. The RF ready light on the front of the Power Source will
illuminate immediately, indicating that the Power Source is ready for use.
2.2 Sealing Procedure with Model 4105 Hand Held Sealing Head
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 2.3. 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.
Figure 2.3 Correct Technique for Holding the Sealing Head
BNC Connector
Seven Pin Connector