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