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.

P/NVT-108732-US, Manual revision: C
2-3
Sealing Head Description
S PECIFICATIONS
Environment The Sealing Head will perform effectively when used in a typical blood bank,
blood processing facility or transfusion center environment. Variations in actual
environmental conditions of the facility and/or the level of contamination and/or
moisture on the RF ground jaws and/or tubing exterior may affect actual perfor-
mance. Users are advised that when temperature and humidity conditions seem
less than what might be considered comfortable for humans, it is best to slow the
rate of repetitive sealing, to be certain the Sealing Head and tubing are clean and
dry, and to frequently check the quality of seal being produced.
Mechanical and
Weight
Table 2-2, Mechanical and Weight Specifications
PARAMETERS SPECIFICATION
Dimensions:
Operating weight:
Shipping weight:
7 in. L x 4 in. W x 4.2 H
(17.8 cm L x 10.2 cm W 10.7 cm H)
5.3 lb
(2.4 kg)
8 lb
(3.6 kg)

P/N VT-108732-US, Manual revision: C
Sealing Head Description
2-4

P/NVT-108732-US, Manual revision: C
3- 4
3-1
SealingHeadOperation
S ETUP
Remove the components from their protective shipping containers and visually
inspect them for obvious damage. Contact Vante
®
Customer Care Center if any
damage is found.
Note: If possible, retain shipping containers and packing materials for future use.
See the Operation Manual for the Model 2600 Power Source for proper setup and
RF power settings.
R ECOMMENDED T UBING
Shown in Table 3-1 are typical size categories and corresponding dimension
ranges of PVC tubing. The Sealer is designed to seal blood bag, transfer sets and
intravenous tubing (small or medium size) with typical outside diameter of 0.148-
1.18 inch (3.8-4.6 mm) and wall thickness of 0.020-0.037 inch (0.5-.94 mm).
Table 3-1, Recommended Tubing
Tubing Size
Category
Outside Diameter
Range
Wall Thickness Range Examples
Small
0.080-0.147 inch
2.0-3.7 mm
0.020-0.030 inch
0.5-0.8 mm
Anti-coagulant
and saline drip
lines
Medium
0.148-0.18 inch
3.8-4.6 mm
0.020-0.037 inch
0.5-.94 mm
Blood bag tubing,
some apheresis
a
a. Although the 2605 may make good seals on apheresis tubing that falls outside
this range, duty cycle and heat buildup may be affected. Call Vante
®
for more
information.
Chapter 3

P/N VT-108732-US, Manual revision: C
Sealing Head Operation
3-2
S EALING P ROCEDURE
Warning: Wear disposable protective gloves while working with blood and
blood products. See Chapter 6.
1. For sealing and segmenting tubing, place the Sealing Head in a convenient
location, allowing clear access to the jaws and routing the cable so that it
does not interfere with other activities.
2. Lay the tubing through the slot of the sealing region, allowing the weight
of the tubing to press against the seal trigger (a slight additional manual
force may be required), as shown in Figure 3-1, Correct Technique for
Holding the Tubing. When the trigger is activated, the RF sealing jaw will
compress the tubing against the ground jaw and RF power will be applied
for approximately one second. After the seal is formed, the sealing jaw
will retract to its original position.
Warning: Do NOT pull the tubing or bag through the sealing region. Under no
circumstances should the tubing be pulled at the instant of sealing. An opening
in the tubing could occur, which will subject the blood or plasma to non-sterile
conditions and the user to potentially hazardous fluids. In addition, the Sealing
Head may become damaged by arcing caused by contamination of the sealing
region.
Note: For clarity, the splash guard is not shown in some of the figures in this man-
ual; however, it should always be in place during the sealing process.
Ground Jaw Movement
Activate Seal Trigger
with Tubing
Figure 3-1, Correct Technique for Holding the Tubing
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 contact, resulting in poor or ruptured seals.

P/NVT-108732-US, Manual revision: C
3- 3
Sealing Head Operation
Figure 3-2, Incorrect Technique for Holding the Tubing
Note: When the Sealing Head is operated, a minor arc discharge may occur be-
tween the sealing jaws.
Note: The Power Source is equipped with a thermal protection switch to prevent
the equipment from becoming damaged. If thermal cutout is reached, the power
source will not work for several minutes until the temperature of equipment low-
ers.
Warning: The Power Source is designed for rapid sealing applications; however,
extreme heavy duty use may result in thermal build up in the jaw area which
can cause hemolysis, poor seal quality or tubing ruptures. If you should
experience these problems, reduce the rate of sealing, as necessary, or allow for
periods of rest for the Sealing Head.
Caution: Never trigger the jaws 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
jaws and poor Sealing Head operation may result.
3. The seal is completed in approximately one second, as indicated when
the sealing jaw retracts. Another seal cannot be made until the sealing jaw
fully retracts and the seal trigger has been completely released. To make
another seal, lift the tubing up to release the trigger and push the tubing
to the next seal position (see Figure 3-3, Repeating the Seal Process).
4. Activate the seal trigger to either the right or left, but for best results, move
the completed seals to the left (while facing the jaws) to avoid their inter-
fering with the seal trigger.

P/N VT-108732-US, Manual revision: C
Sealing Head Operation
3-4
Figure 3-3, Repeating the Seal Process
Warning: Be sure to push the tubing through the sealing region to the next
position. Under no circumstances should the tubing or bag be separated by
pulling it while the sealing jaws are clamped. This action may cause an opening
in the tubing, which will subject the blood or plasma to non-sterile conditions
and the user to potentially hazardous fluids. In addition, the Sealing Head may
become damaged by arcing due to contamination of the sealing region.
Warning: If you observe arcing while making a seal, follow the instructions in
Chapter 5, Table 5-1, "Arcing or Bad Seals." Although a seal made when you
experience arcing may look acceptable, it may be inadequate for centrifugation.
Take precautions as if this is an inadequate seal.

P/NVT-108732-US, Manual revision: C
3- 5
Sealing Head Operation
S EAL S PACING
Seals that progress along a close-ended length of tubing, as in a segmenting process,
must be spaced no less than the blood bag manufacturers recommen-
dation, to
avoid rupture of the tubing due to pressure build-up.
Seals that progress along an open-ended length of tubing may be spaced as
desired, but ½ inch (1 cm) is the recommended minimum.
Multiple seals in close proximity are not required, nor are they recommended
when using the Power Source. If multiple seals must be used, they should be
spaced at least one inch (2.5 cm) apart, as shown in Figure 3-4, Multiple Seal
Spacing.
Figure 3-4, Multiple Seal Spacing
Warning: Never attempt to make segmentation seals closer than recommended
without validating for seal integrity.

P/NVT-108732-US, Manual revision: C
4- 1
C LEANING THE S EALING H EAD
Warning: To obtain satisfactory seals at all times, be sure the sealing region and
all adjacent areas are always kept clean and dry.
Caution: Do NOT, under any circumstances, submerge the Sealing Head in any
kind of liquid. This will damage the RF jaw/tube assembly and void the warranty.
Figure 4-1, Incorrect Cleaning Technique
Note: Other than periodic cleaning, the Sealing Head is designed to be mainte-
nance free and to withstand substantial wear and tear; however, damage may
occur as a result of dropping any of the major components, i.e., the Sealing Head
or the power source. If any component is dropped, examine for obvious damage
and confirm functionality before using. Contact Vante if the Sealing Head fails to
operate properly.
Chapter
4

P/N VT-108732-US, Manual revision: C
Cleaning the Sealing Head
4- 2
T OPICAL C LEANING OF THE S EALING R EGION
Warning: Always wear disposable protective gloves while working with blood
and blood products. See Chapter 6.
Note: Units returned to Vante for repair are subject to biohazard charges if any
Sealing Head component is contaminated with blood or blood products.
See
below for the recommended cleaning.
Warning: Topical cleaning of the Sealing Head is performed in this section using
denatured or isopropyl alcohol. The user should follow the alcohol manufac-
turer's recommendations for usage and be sure that the product material safety
data sheet is carefully understood and observed.
Note: The illustrations in this section show the splash guard removed for clarity.
However, to perform a topical cleaning, it is not necessary to remove the splash
guard.
1. Disconnect the Sealing Head from the power source by removing the RF
power cable and five-pin connector from the power source.
Warning: Failure to separate the Sealing Head from the Power Source prior to
cleaning may result in an RF burn to the operator during the cleaning process.
2. Clean the open sealing region, including the RF jaw, with alcohol (dena-
tured or isopropyl) applied to one end of a cotton swab, as shown in Fig-
ure 4-2, Cleaning the Sealing Region. Be sure the RF power cable is
disconnected from the RF power source!
Figure 4-2, Cleaning the Sealing Region
Caution: Clean the RF jaw, ground jaw and adjacent areas with alcohol only!