Vante SEBRA 2605 User manual

operation manual
VT-108732-US
Model 2605
Segmenting Head
VANTE INC
IGNITING INNOVATION

Printed in USA
Copyright © 2002, 2010, 2017 Vante.

Preface
iii
P/N VT-108732-US, Manual revision: C
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 [phone]
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
v
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
VI
P RELIMINARY I 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

2- 2
P/NVT-108732-US, Manual revision: C
2-1
P RODUCT O 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.
T HEORY OF O 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
C OMPONENT I 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.