sebra 2600 User manual

operation manual
108731-IE
Model 2600
OMNI™ Sealer
PowerSource
VANTE INC
IGNITING INNOVATION

Vante
®
SEBRA
®
Model 2600
OMNI
™
Sealer Power Source
- Operation Manual -
Vante Inc. P/N VT-108731-IE, Manual revision: B
3 4 8 0 E . B r i t a n n i a D r . , S u i t e 1 2 0 Previous SEBRA P/N 26000810-00
Tucson, AZ 85706 USA January 2017

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

Preface
iii
P/N VT-108731-IE, Manual revision: B
C ONSUMER INFORMATION
Proprietary rights The contents of this manual are the property of Vante Inc.
Vante
®
, SEBRA
®
, and OMNI ™ are trademarks or registered trademarks of Vante in
the United States and/or other countries.
Any information or descriptions contained in this manual may not be reproduced
and released to any of the general public, or used in conjunction with any
professional instruction without written consent of Vante, 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 Tel. [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 products. This
manual should be used in conjunction with instruction and training supplied by
qualified Vante personnel.
Any failure to follow 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.

iv
Preface
P/N VT-108731-IE, Manual revision: B

P/N VT-108731-IE, Manual revision: B
Contents
Chapter 1, Introduction
PRELIMINARY INFORMATION........................................................................................ 1-2
Document scope ........................................................................................................1-2
Intendedaudience......................................................................................................1-2
Proprietary information .............................................................................................1-2
SYMBOLS...........................................................................................................................1-3
Symbols found in this document ............................................................................1-3
Symbols found on the device ..................................................................................1-3
DEVICE SPECIFICATIONS .................................................................................................. 1-5
Physical specifications...............................................................................................1-5
Electricalspecifications.............................................................................................1-5
Environmental conditions..............................................................................................1-6
Chapter 2, Product description
PRODUCT OVERVIEW .............................................................................................................. 2-2
THEORY OF OPERATION.................................................................................................. 2-3
Application ................................................................................................................... 2-3
COMPONENT IDENTIFICATION.....................................................................................2-4
OPERATING ENVIRONMENT ................................................................................................ 2-7
SEALING APPLICATIONS................................................................................................... 2-8
PVC TUBING SIZE CATEGORIES .................................................................................... 2-9
SEAL CYCLE..................................................................................................................................2-10
Chapter 3, Power source operation
SETUP ........................................................................................................................................ 3-2
SEALING PROCEDURE WITH MODEL 1105 HAND-HELD SEALING HEAD3-4
SEALING PROCEDURE WITH MODEL 2605 BENCH-TOP SEALING HEAD 3-7
SEAL SPACING.....................................................................................................................3-10
Chapter 4, Maintenance
CLEANING OMNI™POWER SOURCE CASE............................................................. 4-2
TROUBLESHOOTING ................................................................................................................. 4-3
Chapter 5, Failure isolation
FAILURE ISOLATION........................................................................................................... 5-2
FUSE REPLACEMENT .................................................................................................................. 5-3
CUSTOMER SERVICE ............................................................................................................ 5-4
Services ................................................................................................................................5-4
Chapter 6, Radio frequency system safety considerations
Table of

P/N VT-108731-IE, Manual revision: B
viii
Preface
GENERAL INFORMATION................................................................................................6-2
RF effects on human tissue....................................................................................... 6-2
RF effects on pacemakers ..............................................................................................6-2
Electrical safety..................................................................................................................6-2
RF effects on electronic equipment............................................................................6-2
RF effects in potentially explosive atmospheres .....................................................6-2
Chapter 7, Reference information
APPENDIX A: EMC STANDARD REQUIREMENTS..............................................7-2
Operation precautions....................................................................................................7-2
Electromagnetic immunity ........................................................................................ 7-2

P/N VT-108731-IE, Manual revision: B
Figures
Figure 2-1, OMNI™ Sealer with Hand-Held and Bench-Top Sealing Heads. 2-2
Figure 2-2, Model 2600 OMNI™ Sealer Components ...........................................2-4
Figure 2-3, OMNI™Power Source Power Interface Panel .........................................2-6
Figure 2-4, Serial Plate Label for OMNI™ Power Source.......................................2-6
Figure 3-1, RF Power Cable Attachment (For Use with a Model 1105)............... 3-2
Figure 3-2, Model 2605 Bench-Top Sealing Head Cable Attachment..................3-3
Figure 3-3, Correct Technique for Holding the Sealing Head................................3-4
Figure 3-4, Incorrect Technique for Holding the Sealing Head.............................3-5
Figure 3-5, Maintaining Compression During the Entire Sealing Process . . . 3-5
Figure 3-6, Releasing the Sealing Head Lever at Seal Completion.......................3-6
Figure 3-7, Correct Sealing Method .............................................................................3-7
Figure 3-8, Incorrect Sealing Method ..........................................................................3-8
Figure 3-9, Repeating the Seal Process........................................................................... 3-8
Figure 3-10, Multiple Seal Spacing........................................................................3-10
Figure 5-1, Releasing Fuse Holder Latch ....................................................................5-3
Listof

P/N VT-108731-IE, Manual revision: B
Introduction
PRELIMINARY INFORMATION .......................................................................................1-2
Document scope...................................................................................................... 1-2
Intended audience............................................................................................. 1-2
Proprietary information.......................................................................................... 1-2
SYMBOLS........................................................................................................................... 1-3
Symbols found in this document ........................................................................1-3
Symbols found on the device.................................................................................1-3
DEVICE SPECIFICATIONS ............................................................................................ 1-5
Physical specifications ............................................................................................1-5
Electrical specifications..........................................................................................1-5
Environmental conditions....................................................................................... 1-6
Chapter 1

P/N VT-108731-IE, Manual revision: B
1-2
Introduction
P RELIMINARY INFORMATION
Document scope This manual is a guide for the operation, care and maintenance of the Vante
®
SEBRA
®
Model 2600 OMNI
™
Sealer (hereinafter referred to as "the Power
Source").
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.
Proprietary
information
The Power Source is protected by U.S. Patent Number 5349166.

P/N VT-108731-IE, Manual revision: B
Introduction
1-3
S YMBOLS
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.
Shock hazard
Caution
Consult accompanying documents)
Protective earth (ground)
Identifies any terminal intended for connection to an external conductor, for pro-
tection against electrical shock in case of a fault.
Caution, Hot Surface
Power ON
Power OFF
Fuse

P/N VT-108731-IE, Manual revision: B
1-4
Introduction
Electrical and electronic equipment waste (applies to EU only)
Dispose of the device using a separate collection method (according to EU and
local regulation for waste electrical and electronic equipment).
Serial number
Catalog number
Manufacturer
Authorized representative in the European Community
EC
REP

P/N VT-108731-IE, Manual revision: B
Introduction
1-5
D EVICE SPECIFICATIONS
Physical
specifications
The approximate dimensions and weight of the Model 2600 device are as
follows:
Table 1-1, Physical Specifications
Parameter
Specification
Power source dimensions
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
specifications
The electrical specifications for operating the Model 2600 device are as follows:
Table1-2,ElectricalSpecifications
Parameter
Specification
Power input
100-120/220VAC, 50-60 Hz
Current draw
6.3 A/4A INTERMITTENT
RF power output
150 watts minimum into matched 50 Ω
load, at initial power -up
Primary frequency
40.68±0.02 MHz

P/N VT-108731-IE, Manual revision: B
1-6
Introduction
Environmental
conditions
The following environmental conditions should be respected pertaining to
operation and storage of the Model 2600 device:
Table 1-3, Environmental Conditions
Condition
Value
Installation category
1
Pollution degree
2
Ambient operating temperature
4º-38ºC
Operating humidity level
90 percent maximum relative humidity,
non-condensing
Warning: Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.

P/N VT-108731-IE, Manual revision: B
Product description
PRODUCT OVERVIEW.......................................................................................................2-2
THEORY OF OPERATION................................................................................................... 2-3
COMPONENT IDENTIFICATION..................................................................................... 2-4
OPERATING ENVIRONMENT .........................................................................................2-7
SEALING APPLICATIONS.............................................................................................2-8
PVC TUBING SIZE CATEGORIES....................................................................................... 2-9
SEAL CYCLE...................................................................................................................................2-10
Chapter 2

P/N VT-108731-IE, Manual revision: B
2-2
Product description
P RODUCT OVERVIEW
The Vante
®
SEBRA
®
Model 2600 OMNI
™
Sealer is a compact, portable device
that employs radio frequency (RF) to make uniform, quality seals on a variety
of tubing sizes without power adjustment by the user. The Power Source
consists of the Model 2600 Power Source ("the Power Source") and the Model
1105, a hand-held, manually-activated sealing head or the Model 2605, a bench-
top automatic 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 2-1, OMNI
™
Sealer with Hand-Held and Bench-Top Sealing Heads

P/N VT-108731-IE, Manual revision: B
Product description
2-3
T HEORY OF OPERATION
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 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 design, allowing various tubing sizes to be automatically
accommodated. The Power Source requires no manual power or timing
adjustment by the user.
Application The Model 2600 Power Source is an instrument for making seals on tubing made
of RF reactive thermoplastic materials typically used in blood banks, blood
processing facilities and transfusion centers. Tubing utilized in the collection and
handling of blood and blood products is typically made from thermoplastic vinyl,
namely polyvinylchloride, or PVC, and it is this application for which this
product is specifically intended.

P/N VT-108731-IE, Manual revision: B
2-4
Product description
C OMPONENT IDENTIFICATION
The Model 2600 Power Source, when coupled with the various sealing heads,
becomes a system. Figure 2-2, Model 2600 OMNI™ Sealer Components shows
the component parts of the sealing system with a Hand-Held Sealing Head and
a Bench-Top Sealing Head. Table 2-1, “Power Source Component Functions,”
on page 2-5indicates the function of each component.
OMNI
™
Power Source
Splash Guards
Splash Guards
Model 2605
Bench-Top
Sealing Head
Model 1105
Sealing Head
AC Power Cord
(Cord Varies with Country)
Model 1103 RF Power Cable
(Standard)
Figure 2-2, Model 2600 OMNI™ Sealer Components