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Vante ® 3480 E. Britannia Dr., Suite 120 Tucson, AZ 85706 USA Telephone (520) 881-6555 (520) 323-9055 Toll Free (877) 565-5557 Part No. 41050810-01 Rev. D 5/10 Vante ®...
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) ®...
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.
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 ..................
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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...
Model 4105 ® 1. Sealing Head Description 1.1 Product Overview Model 4105 Hand-Held Sealing Head (“the Sealing Head”) is part of a The Vante ® 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 ®...
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 on Sealing Head that indicates duration of RF power.
Vante Model 4105 ® 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.
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Model 4105 ® 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.
Vante Model 4105 ® 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.
Vante Model 4105 ® 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...
Vante Model 4105 ® 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.
Vante Model 4105 ® 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.
Vante Model 4105 ® 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...
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 ®...
® 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.
Vante Model 4105 ® Figure 3.3 Cleaning the Sealing Region After cleaning the contaminated areas of the sealing region, immediately dry with the dry end of the cotton swab (Figure 3.4). Figure 3.4 Drying the Sealing Region Clean all areas adjacent to the sealing region using an alcohol-moistened cotton swab, giving special attention to grooves and other recesses where fluids or other contaminates may become trapped.
Vante Model 4105 ® Figure 3.5 Cleaning Ground and RF Jaw Surfaces Figure 3.6 Drying Ground and RF Jaw Surfaces Verify the movement of the ground jaw while squeezing the lever before returning the Sealing Head to service. The sealing region should close evenly before the lever comes in contact with the tube body (see Figure 3.2).
® 3.2 Disassembly of the Sealing Head NOTE: The Sealing Head is designed for quick disassembly for cleaning ease. Vante ® recommends inspecting the Sealing Head daily when in high use applications. If biopharmaceutical products are present, follow this procedure to clean the Sealing Head.
Vante Model 4105 ® Figure 3.7 Releasing Spring Tension in Sealing Head Slightly release the ground jaw. Remove the lever by rotating it away, and pulling it down from the RF jaw as shown in Figure 3.8. Remove ground jaw by pulling jaw up and away as shown in Figure 3.8.
Vante Model 4105 ® Figure 3.8 Removing the Lever and Ground Jaw Note that three separate components, the lever, the ground jaw and the RF jaw/tube assembly are now easily accessible for individual cleaning. Figure 3.9 Sealing Head Components...
Vante Model 4105 ® 3.3 General Cleaning of the Sealing Head Once the Sealing Head is disassembled (see Section 3.2 for step-by-step instructions), use or equivalent to disinfect (follow manufacturer’s instructions). Use alcohol ® Amphyl applied to a cotton swab to clean the ground jaw and RF jaw, paying particular attention to the small grooves and slots on the plastic portion of the head (see Figure 3.10).
Vante Model 4105 ® Figure 3.11 Installation of Ground Jaw onto RF Jaw/Tube Assembly With thumb, slide ground jaw down the grooves in the RF jaw, maintaining constant pressure to depress the ground jaw spring. Replace lever so that its internal pivot pins slide in beneath the bottom edge of the ground jaw and are positioned to enter into the pivot pin slots (see Figure 3.12 and Figure 3.13).
Vante Model 4105 ® Continue to hold the ground jaw in its retracted position and tip the lever up so the lever roller clears the ground jaw stop. Small adjustments in thumb pressure may be required to accomplish this action. Firmly push the lever to engage its internal pivot pins into their respective slots while slowly releasing ground jaw.
Vante Model 4105 ® Figure 3.14 Final Assembly of Sealing Head Verify the Sealing Head’s mechanical functions by squeezing the lever. The sealing region should close evenly before the lever comes in contact with the tube body (see Figure 3.2).
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Vante Model 4105 ® 4.2 Spring Replacement 4.2.1 Turn off the power supply and disconnect the Sealing Head from the RF cable. WARNING: Failure to disconnect Sealing Head from the power supply prior to replacing the spring may result in an RF burn.
4.3 Returning a Unit for Repair The Sealing Head is designed to be maintenance free, except for cleaning and occasional spring replacement. Do not attempt any other field repair. Questions regarding repairs should be directed to an authorized Vante repair center. ®...
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When in operation, these RF instruments emit radio frequency energy to people, other instruments, and equipment located in close proximity. Current Vante ® instruments operate at a frequency authorized by the Federal Communications Commission (FCC) and the International Telecommunications Union (ITU) for industrial, scientific, and medical (ISM) use.
Vante Model 4105 ® 5.6 RF Effects In Potentially Explosive Atmospheres Do not operate Vante RF instruments in any area with a potentially explosive ® atmosphere. It is possible for the RF electrodes to arc, initiating an explosion or fire.