Vante SEBRA MINI 2380 User manual

operation manual
VT-108723-US
MINI™ Model 2380
Hand-Held Tube Sealer
PowerSource
VANTE INC
IGNITING INNOVATION

ii
© 2007–2011, 2017 Vante Inc. All rights reserved.

iii
Consumer information
Proprietary
rights The contents of this manual are the property of Vante.
Vante®,SEBRA®, and
MINI™ aretrademarksor registered trademarks
of Vante in the United States
and/or other countries. Any
other trademarks noted herein are registered
trademarks of their respective
owners. Anyinformationanddescriptions
contained in this manualmay not be
reproduced, released to 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. Dmitrij Velikan
3480 E. Britannia Dr. Suite 120 Marquip WardUnited GmbH
Tucson, AZ 85706 Otto-Hahn StraBe 54
U.S.A. 63303 Dreieich-Sprendlingen, Germany
Tel. [+1] 520-881-6555 [phone]
Fax [+1] 520-323-9055
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 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.

Vante® SEBRA® MINI™ Tube Sealer Power Source
P/N VT-108723-US, Manual revision: C
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Vante® SEBRA® MINI™ Tube Sealer Power Source
P/N VT-108723-US, Manual revision: C
Chapter 1, Introduction
Preliminary information....................................................................................1
Document scope.........................................................................................1
Intended audience......................................................................................1
Symbols...........................................................................................................1
Symbols found in this document................................................................1
Symbols found on the device.....................................................................2
Device specifications.......................................................................................3
Physical specifications................................................................................3
Environmental conditions ...........................................................................3
Electrical specifications...............................................................................4
Chapter 2, Product description
Product overview.............................................................................................5
Application..................................................................................................5
Theory of operation..........................................................................................5
Component identification.................................................................................7
Operating environment....................................................................................9
PVC tubing size categories ...........................................................................10
Sealing modes...............................................................................................10
Duty cycle ......................................................................................................11
Seal spacing..................................................................................................12
General guidelines....................................................................................12
Chapter 3, Power source operation
Setup and sealing procedure ........................................................................13
Chapter 4, Battery power source
Battery replacement.......................................................................................18
Battery charging.............................................................................................20
Chapter 5, Cleaning and maintenance
Cleaning and maintenance............................................................................23
Cleaning the power source case..............................................................23
Troubleshooting and maintenance...........................................................24
CUSTOMER SERVICE ....................................................................................25
Services....................................................................................................25
Table of
Contents

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Chapter 6, Radio frequency system safety considerations
General information......................................................................................27
RF effects on human tissue.....................................................................27
RF effects on pacemakers.......................................................................27
Electricalsafety........................................................................................27
RF effects on electronic equipment.........................................................27
RF effects in potentially explosive atmospheres ......................................27
List of Figures
Figure 2-1, 2380 MINI™ Hand-Held Tube Sealer Components................... 7
Figure 2-2, Model 2380 Power Interface Panel ........................................... 7
Figure 2-3, Serial Plate for Model 2380....................................................... 8
Figure 3-1, Opening Battery Compartment Door......................................... 13
Figure 3-2, Battery Connector Location....................................................... 14
Figure 3-3, Properly Installing the Battery.................................................... 14
Figure 3-4, Battery to Power Source Connection ........................................ 15
Figure 3-5, Attachment of RF Power Cable................................................. 15
Figure 4-1, Properly Removing the Battery Using the Strap..........................19
Figure 4-2, Properly Removing the Batteryby Sliding.................................. 19

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P/N VT-108723-US, Manual revision: C Vante® SEBRA® MINI™ Tube Sealer Power Source
Preliminary information
Document
scope This manual is a guide for the operation, care, and maintenance of the
Vante®
SEBRA® Model 2380 MINI™ Hand-Held Tube Sealer Power Source.
Intended
audience
Symbols found
in this
document
This manual is intended for use by personnel having technical skills and a
thorough understanding of the products, procedures, and safetyrequirements
for the collecting, processing and handling of blood and/or blood products
The terms Note, Caution and Warning are used in this manual with the
following symbols to notify the operator of important and/orcritical 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.
Chapter
1

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Symbols found
on the device The following symbols may be found on the device or device packaging.
Shock hazard
Attention
Consultaccompanyingdocuments.
Protective earth (ground)
Identifies any terminal intended for connection to an external
conductor, for protection against electrical shock in case of a
fault.
Power ON
Power OFF
Fuse
Serial Number
Catalog Number
Manufacturer

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P/N VT-108723-US, Manual revision: C Vante® SEBRA® MINI™ Tube Sealer Power Source
Device specifications
Physical
specifications Table 1-1, Physical Specifications
Environmental
conditions
Length/cm(in.) Height/cm
(in.) Width/cm (in.)
Sealing head 20.3 cm (8.0 in) 2.5 cm (1.0 in) 3.8 cm (1.5 in)
Power source 33.8 cm (13.3 in) 4.1 cm (1.6 in) 12.2 cm
(4.8 in)
Weight of
sealing head 0.3 kg (0.6 lbs)
Weight of
power source,
carryingpouch,
strap, and
batterypack
2.1 kg (4.7 lbs)
Table 1-2, Environmental Conditions
Condition Value
Ambientoperating
temperature 4 °C to 38 °C (39.2 °F to 100.4 °F)
Storage/transportation
temperature -12 °C to 50 °C (10 °F to 122 °F)
Operating humidity level Maximum relative humidity 70%
Pollution degree 2
Warning: Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.

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Electrical
specifications Table 1-3, Electrical Specifications
Parameter Specification
Power source 12 V NiCad battery pack
Batterycharger
Input
Output
100-240VAC, 50-60 Hz
15VDC, 55mA and 1.4A
RF power output 40 watts minimum into matched 50Ωload, at initial
power up
Primary
frequency 40.68±0.02 MHz

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P/N VT-108723-US, Manual revision: C Vante® SEBRA® MINI™ Tube Sealer Power Source
Product overview
The Vante® SEBRA® Model 2380 MINI™ Hand-Held Tube Sealer Power
Source (Sealer) is a compact, portable, battery powered device that
employs
SMART™ electronics (which detect the end of the seal and arcing
problems)
to generate radio frequency (RF) to make uniform, quality seals on
a variety
of tubing sizes without power adjustment by the user. The Sealer
comes with
a hand-held, manually activated sealing head (the Model 1105)
which
creates a seal that is formed by the sealing head jaws in such a way as
to
take segment separation easy and uniform.
The Model 2380 is approved for sealing the blood collection tubing while the
blood collection needle remains in the donor's arm.
Application The Model 2380 Power Source is an instrument that generates RF power 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
typicallymadefrom thermoplasticvinyl, namelypolyvinylchloride,or PVC,and
it is this application for which this product is specifically intended.
Theory of operation
The physical properties of PVC plastic tubing (and other RF-reactive
thermoplasticmaterials)causeittodielectricallyheatatamolecularlevelinthe
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
applicationof externalforces,suchascompression.Ifallowedto coolwhilethe
forces are applied, the material will be permanently reshaped.
ThePowerSourceisaninstrumentthatgenerates,whenactuated,acontrolled
amount of RF energyat 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.
Note: Since the Power Source generates RF, other instruments or equipment
in its proximity may be affected by radio frequency interference (RFI) unless
their electronic circuitry is properly shielded for RFI.
Chapter
2

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The Power Source generates RF power, the frequency of which is controlled
byasolidstateoscillator/amplifieroperatingat40.68MHz.TheRFenergylevel
andsealtimearecontrolledbymeansof aproprietarysolidstatecircuitdesign,
allowingvarious tubingsizes to be automaticallyaccommodated.Additionally,
a built-in arc detect mode will normally preclude sealing if the tubing exterior,
ground jaw and/or RF jaw surfaces are affected by contamination and/or
moisture. Thus, the Model 2380 Tube Sealer requires no manual power or
timing adjustment by the user.
The Power Source will automatically detect a battery low condition, notifying
theoperator of impendingseal deteriorationvia visual andaudibleindications.
This detection circuit is activated when the battery voltage has dropped to a
point in which a limited number of good seals remain.

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P/N VT-108723-US, Manual revision: C Vante® SEBRA® MINI™ Tube Sealer Power Source
1. 3.
2.
4.
5.
6.
Component identification
1. Model 2380 RF power
source
2. Operation manual
3. Model 2380200 battery
pack
4. Model 1103 RF power
cable (Optional Model
1109coiledcablenotpic-
tured)
5. Carrying strap
6. Batterycharger
7. Powercord
8. Carrying pouch
2-1 shows the component Sealer parts.
Figure 2-1, 2380 MINI™ Hand-Held Tube Sealer Components
Shownin 2-2,is thepower interface panel on thefront of theRFpowersource.
The serial plate (2-3), located on the underside of the RF power source,
indicates the model number and serial number of the unit.
Refer to the serial number when contacting Vante® Customer Care Center.See
Table 2-1,“2380SealerComponentFunctions,”onpage 8for a
complete
description of the functions of the indicated items.
RFReady Light
PowerSwitch
BatteryLowIndicator Light
RFPowerOutut
Serial Plate on Underside of Unit
Figure 2-2, Model 2380 Power Interface Panel
1.
2.
3.
8.
7.
4.
6.
5.

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Figure 2-3, Serial Plate for Model 2380
Component Function
Model 2380 RF Power
Source Provides RF power to the sealing head. Automatically controls sealing time.
Carrying Pouch and Strap Provides finish protection to and easy transport
of RF power source. Also provides storage for
the sealing head and RF power cable.
RF Ready Light Green LED located on the unit's power
interface panel, labeled "PWR". Illuminates
when RF power is ready.
Model 1105 Sealing Head Hand-held, manually activated unit consisting
of the RF jaw/tube assembly, ground jaw and
lever. Seals tubing bycompressing it between
the RF and ground jaws while applying RF
energy. Jaws must remain closed for one
second after indicator light turns off.
Model 23802000 Battery
Pack Rechargeable 12V NiCad battery which provides power to the RF power source.
Model 1103 or Model
1109 RF Power Cable Connects the sealing head to the RF power
source, at the RF power output connector
located on the front of the unit.
Model 2389 Battery
Charger Provides external battery charging capability.
CANNOT BE USED AS AN AC ADAPTER
FOR THE RF POWER SOURCE.
Power Switch Turns battery power "on" or "off". Rocker type
switch located on the power interface panel of
the RF power source next to the RF ready
light.
Table 2-1, 2380 Sealer Component Functions

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P/N VT-108723-US, Manual revision: C Vante® SEBRA® MINI™ Tube Sealer Power Source
Table 2-1, 2380 Sealer Component Functions
Operating environment
The Power Source will perform effectively when used in a typical blood bank,
bloodprocessingfacilityortransfusioncenterenvironment.Variationsinactual
environmentalconditionsof thefacilityand/orthe levelofcontaminationand/or
moisture on the ground and RF jaws and/or tubing exterior may affect actual
performance. Users are advised that when temperature and humidity
conditions seem less than what might be considered comfortable for humans,
itis besttoslowtherateofrepetitivesealing,tobecertainthesealingheadand
tubing are clean and dry, and to frequently check the quality of seal being
produced.
The Power Source and Sealing Head should be stored between 10° and 122°
F (-12°and 50°C). To ensure optimal performance, it is recommended that the
sealer be acclimated to the ambient environmental operating temperature for
approximately one hour prior to use.
RF Power Output Female BNC connector providing RF power to
the Model 1105 sealing head through the RF
power cable. Located on the power interface
panel.
Battery Low Light Amber LED located on the front of the RF
power source. Illuminates when the battery
requires recharging. An audible signal is also
sounded to alert the user of the low battery
condition.
Serial Plate Indicatesthemodelnumber,the serialnumber,
and the required power input of the RF power
source. Located on the underside of the unit.

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PVC tubing size categories
Shown in Table 2-2 are typical recommended size categories and
corresponding dimension ranges of PVC tubing which can be sealed with the
Power Source.
Note: Sealing modes (see “Sealing modes” on page 2-9) are defined for each
category of tubing size. Be sure the category of tubing size being sealed is
determined and the sealing mode guidelines are checked before using the
Sealer (Table 2-2).
Table 2-2, PVC Tubing Size Categories
Tubing
Size
Category
Outside
Diameter
Range
Wall Thickness
Range Examples
Small 0.080-0.147inch
2.0-3.7 mm 0.020-0.030inch 0.5-0.8 mm Anti-coagulantand
saline drip lines
Medium 0.148-0.179inch
3.8-4.5 mm 0.020-0.035inch 0.5-.89 mm Blood bag tubing
Large 0.180-0.250inch
4.6-6.4 mm 0.030-0.04 inch 0.8-1.02 mm Apheresis and
dialysis sets
Sealing modes
"Intermittent" mode refers to a sealing process in which no more than 5 seals
are produced rapidly (as quickly as the Sealer can normally produce for the
tubing size being used) within a minimum 1 minute time period. For example,
if it takes 10 seconds to produce 5 seals, then the Sealer must sit idle for at
least 50 seconds. This sealing mode may be used for tubing of ALL sizes.
"Continuous" mode refers to a sealing process in which seals are made at
regularlyspacedtimeintervalsforanextendedperiod.Thismodemaybeused
for tubing of MEDIUM (typically, blood bag tubing) size only.
Note: To perform continuous sealing on tubing of SMALL and LARGE sizes, a
different sealer may be required. Contact Vante for more information.
"Maximum" mode, which may be used for tubing of MEDIUM and LARGE sizes
only, refers to sealing in which a prescribedmaximum number of seals is made
at a rapid, repetitive rate, followed by a specified period of no Sealer activity.
Note: To perform maximum sealing on tubing of small size, a different sealer
may be required. Contact Vante for more information.

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Duty cycle
The Sealer "duty cycle" is defined as the time period, in seconds, between
consecutive, repetitive seals. It is significant for continuous and maximum
modes only; intermittent mode has no strict time interval between seals.
Warning: Every sealing mode must always be performed in accordance
with the sealing procedures described in Chapter 3 of this manual.
Table 2-3 lists suggested duty cycles to help users estimate their maximum
allowed sealing rate(s).
Table 2-3, Suggested Duty Cycles
Sealing
Head Sealing Mode PVC Tubing
Size
Duty
Cycle Defined As
Model 1105 Intermittent All As required No more than
5sealswithina
1 minute time
period
Continuous Small
Medium
Large
--
3 seconds
--
Not
recommended
Seal rate
equivalent of
1200 seals per
hour
Not
recommended
Maximum Small
Medium
Large
--
2 seconds
6 seconds
Not
recommended
Maximum 50
seals in 1
minute 40
seconds, then
none for 4
minutes
Maximum 10
seals in 1
minute, then
none for 10
minutes

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Seal spacing
Note: The Sealer is designed to allow repetitive seals to be made on a length
of tubing filled with blood or blood products. However, several factors control
howcloselythesealsmay bespaced.Forstandardbloodbagtubing,followthe
instructions provided by the bag manufacturer.
General
guidelines
Seals that progress along an open-ended length of tubing may be spaced as
desired, but ½ inch (1 cm) is the recommended minimum.
Seals that progress along a close-ended length of tubing, as in a segmenting
process, must be spaced approximately one inch (2.5 cm) to avoid rupture of
the tubing due to pressure build-up.
Warning: Never attempt to make segmentation seals closer than
recommended without validating for seal integrity.

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Setup and sealing procedure
1. 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.
2. For optimal performance, batteries should be fully charged prior to use.
3. Check to see that the power switchis in the off position. Open the battery
compartment door on the power source case by sliding the latch to the
right. See 3-1.
Figure 3-1, Opening Battery Compartment Door
4. Position the battery connector as shown in 3-2.
Caution: Use only with battery packs equipped with a Positive Thermal Cutout
(PTC) device and approved for use with Vante® SEBRA® Model 2380
MINI™.
Chapter
3

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Figure 3-2, Battery Connector Location
5. Ensure the connectors are positioned on the side (not the top or bottom)
of the battery. Slide the battery into the battery compartment by holding
the battery underneath and ensuring the wires are aligned properly (See
3-3, below).
Note: Ensure the latch is underneath the device and position hand underneath
the battery while inserting in the case. This prevents any damage to the wires
or battery. Do not pull on the wires.
Position hand
underneath
batteryto insert
Latch is
underneath
device.
Figure 3-3, Properly Installing the Battery
6. Once the battery is fully seated, engage the RF power source connector
to the battery connector. See 3-4.