Vante SEBRA 2605 Manuale utente

operation manual

VT-108732-US

Model 2605

Segmenting Head

VANTE INC

IGNITING INNOVATION

Printed in USA

Preface

iii

P/N VT-108732-US, Manual revision: C

ONSUMER INFORMATION

Proprietary rights The contents of this manual are the property of Vante Corporation.

Vante

and

SEBRA

are trademarks or registered trademarks of

Vante

Corporation in the United States and/or other countries. Any other

trademarks

noted herein are registered trademarks of their respective owners.

Any

information and descriptions contained in this manual may not be

reproduced,

released to the general public, or used in conjunction with any professional

instruction without written consent of Vante Corporation,

USA. Please direct

any written inquiries to the appropriate address.

USA Location: Representative in Europe:

Vante Inc. Mr. Dimitrij Velikan

3480 E. Britannia Dr., Suite 120 MarquipWardUnited GmbH

Tucson AZ 85706 Otto-Hahn StraBe 54

U.S.A. 63303 Dreieich-Sprendlingen,

Tel. [+1] 520-881-6555 Germany

Fax [+1] 520-323-9055 +49 (0) 6103-3809-66

Toll free: [1] 877-565-5557

Disclaimer

This manual is intended as a guide to provide the operator with necessary

instructions on the proper use and maintenance of certain Vante

Corporation products. This manual should be used in conjunction with

instruction and training supplied by qualified Vante personnel.

Any failure to following the instructions as described could result in impaired

product function, injury to the operator or others, or void applicable product

warranties. Vante accepts no responsibility for liability resulting from

improper

use or maintenance of its products.

Utilization of Vante products may require the operator to handle and

dispose of

blood-contaminated material. An operator must fully understand and

implement

all regulations governing the safe handling of blood products and

waste,

including the policies and procedures of their facility.

Handling and use of any blood products collected using Vante equipment

are

subject to the decisions of the attending physician or other qualified medical

personnel. Vante makes no warranty with respect to such blood products.

P/NVT-108732-US, Manual revision: C

Table of Contents

Chapter 1, Introduction

PRELIMINARY INFORMATION...................................................................... 1-1

Document scope...............................................................................................1-1

Intended audience ....................................................................................... 1-1

SYMBOLS ..................................................................................................... 1-1

Symbols found in this document.....................................................................1-1

Symbols found on the device ...................................................................... 1-1

Chapter 2, Sealing Head Description

PRODUCT OVERVIEW................................................................................. 2-1

Application .................................................................................................. 2-1

THEORY OF OPERATION ......................................................................... 2-1

COMPONENT IDENTIFICATION............................................................... 2-2

SPECIFICATIONS........................................................................................... 2-3

Environment......................................................................................................2-3

Mechanical and Weight ...................................................................................2-3

Chapter 3, Sealing Head Operation

SETUP .......................................................................................................... 3-1

RECOMMENDED TUBING...............................................................................3-1

SEALING PROCEDURE................................................................................. 3-2

SEAL SPACING.............................................................................................. 3-5

Chapter 4, Cleaning the Sealing Head

CLEANING THE SEALING HEAD ............................................................... 4-1

TOPICAL CLEANING OF THE SEALING REGION........................................ 4-2

SPLASH GUARD REPLACEMENT................................................................... 4-4

CLEANING SEALING HEAD CASE ................................................................ 4-6

Chapter 5, Repair

TROUBLESHOOTING ................................................................................... 5-1

CUSTOMER SERVICE......................................................................................... 5-2

Services..............................................................................................................5-2

Chapter 6, Handling Blood and Blood Products

CLEANING AND DISPOSAL PROCEDURES.................................................. 6-1

Be prepared ............................................................................................... 6-1

Maintain awareness .......................................................................................6-1

Protect others.................................................................................................. 6-1

1-2

1-1

P/N VT-108732-US, Manual revision: C

vi Table of contents

Confine and absorb the spill ...................................................................... 6-1

Disinfect..................................................................................................... 6-2

Decontaminate equipment ........................................................................... 6-2

Safely dispose of waste ................................................................................. 6-2

Chapter 7, Radio Frequency System Safety Considerations

GENERAL INFORMATION ........................................................................7-1

RF Effects On Human Tissue.......................................................................... 7-1

RF Effects On Pacemakers ....................................................................................7-1

Electrical Safety ............................................................................................ 7-1

RF Effects On Electronic Equipment ............................................................... 7-1

RF Effects In Potentially Explosive Atmospheres ........................................... 7-1

List of Figures

Figure 2-1, Model 2605 Segmenting Head...................................................... 2-2

Figure 3-1, Correct Technique for Holding the Tubing......................................... 3-2

Figure 3-2, Incorrect Technique for Holding the Tubing...................................... 3-3

Figure 3-3, Repeating the Seal Process.................................................................3-4

Figure 3-4, Multiple Seal Spacing ..................................................................... 3-5

Figure 4-1, Incorrect Cleaning Technique .............................................................. 4-1

Figure 4-2, Cleaning the Sealing Region........................................................... 4-2

Figure 4-3, Drying the Sealing Region.............................................................. 4-3

Figure 4-4, Removing Splash Guard from Sealing Head .................................. 4-4

Figure 4-5, Removing Adhesive Residue..............................................................4-5

P/N VT-108732-US, Manual revision: B

RELIMINARY

NFORMATION

Document scope

This manual is a guide for the operation, care and maintenance of the

Vante

SEBRA

Model 2605 Segmenting Head.

Intended

audience

This manual is intended for use by personnel having technical skills and a

thorough understanding of the products, procedures, and safety requirements for

the collecting, processing and handling of biological products.

Symbols found in

this document

The terms Note, Caution and Warning are used in this manual with the following

symbols to notify the operator of important and/or critical information.

Note: provides useful information regarding a procedure or operating technique

when using Vante material.

Caution:

advises the operator against initiating an action or creating a situation

that could result in damage to equipment, or impair the quality of the blood

products; personal injury is unlikely.

Warning: advises the operator against initiating an action or creating a situation

that could result in serious personal injury to the donor, the operator, or the

blood product recipient.

Symbolsfoundon

the device

The following symbols may be found on the device or device packaging.

Caution, risk of electric shock

Caution (refer to accompanying documents)

Protective Earth (PE)

Power on

Power off

Fuse

Serial number

Catalog number

Chapter 1

P/NVT-108732-US, Manual revision: C

2-1

RODUCT

VERVIEW

The Vante

SEBRA

Model 2605 Segmenting Head ("the Sealing Head")

is part

of a system that employs radio frequency (RF) to make uniform, quality

seals

on blood bags, transfer sets and IV tubing. A Vante SEBRA Model

2600 RF

Power Source 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 blood and/or blood products in the unlikely event of

tubingrupture

Application

The Model 2605 Segmenting Head is part of a system and cannot be used

independently. When used in conjunction with the Model 2600 RF Power

Source, it is the instrument used to make seals on tubing or bags made of RF

reactive thermoplastic materials typically used in blood banks, blood processing

facilities and transfusion centers. Tubing or bags utilized in the collection and

handling of blood and blood products is 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.

HEORY OF

PERATION

The physical properties of PVC plastic tubing (and other RF-reactive thermo-

plastic 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 Power

Source 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.

Chapter 2

P/N VT-108732-US, Manual revision: C

Sealing Head description

2-2

OMPONENT

DENTIFICATION

Figure 2-1, Model 2605 Segmenting Head, illustrates the Sealing Head. Table 2-

1 indicates the function of each component included with the Sealing Head.

Ground

Jaw

RF Jaw

RF Power Cable

Seal Trigger

Model 2605

Sealing Head

Seven Pin Connector

Splash Guards

Figure 2-1, Model 2605 Segmenting Head

Table 2-1, Sealing Head Component Functions

Component

Function

Ground Jaw

Compresses tubing while RF is applied to form

seal.

RF Jaw

Delivers RF energy to tubing to form seal.

Splash Guard

Protects the operator from accidental exposure

to blood or blood products in the unlikely event

of a tubing rupture.

Seal Trigger

A microswitch that activates the sealing head

jaws.

RF Power Cable

Provides RF power connection to the Model

2600 Power Source.

Seven Pin Connector

Provides control voltage connection to the

Model 2600.

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