baxter Fenwal Hematron 4R4330 User manual

Operator’s Manual
Fenwal®
Hematron® Dielectric Sealer
4R4330/4R4340
Baxter

Operator’s Manual
Baxter Healthcare Corporation
Fenwal Division
Deerfield, IL 60015 USA
Printed in USA
Hematron® Dielectric Sealer
7-19-8-33
Rev. February 1990
1

7-19-8-33
Table of Contents Page/Pages
O AR 5
Introduction 3
Description
Accessories
Operation
Unpacking
Installation
Operating Instructions
Routine Maintenance .
Sealer Head Cleaning .
FOCIRCNUIAMENISO оне ere as-tu seen tenons
Warranty and Service
List of Illustrations and Table
Hematron® Dielectric Sealer, Front View
Figure 2-1 Hematron® Dielectric Sealer, Rear View 4
Figure 2-2 Sealing Tubing 9
Figure 2-3 Shield Removal NT
Figure 2-4 Sal Heat CBN ss. cias pio Me e see Descendre cree... See
Table: 1511 'Specitications/ se siemens silelim ala sile ela ala e e ea nen 3

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1.0 General Information
1.1 Introduction
This manual contains operation and routine maintenance information for the
4R4330 and 4R4340 Hematron® Dielectric Sealers from Baxter Healthcare Corporation.
1.2 Description
The Hematron® Dielectric Sealer is an electronic device designed to automatically produce hermetic, snap-apart
seals in Blood-Pack® Unit tubing. Seals are made by placing the tubing in the sealer head and depressing a trip
switch. Segments may be formed by advancing the tubing through the sealer head to produce a series of
seals.
The 4R4330 operates on 115 VAC 50-60 Hz input power and the 4R4340 operates on either 115 VAC or
230 VAC 50-60 Hz input power. Heat range may be selected to provide sealing intensity appropriate to tubing
wall thickness and line voltage. See Table 1-1 for specifications.
Table 1-1 Specifications
Parameter Value/Description
Listing 4R4330: CSA, UL, FCC Grant of Certification, Section 18.125
Input Voltage 4R4330: 115 VAC
Input Frequency
Input Power
Input Current
Dielectric Strength
Fuse
Dimensions
Weight
RF Frequency
Maximum Tubing Size
Power Cord
Storage Humidity
Storage Temperature
4R4340: 230 VAC
50/60 Hz
150 Watts maximum
4R4330: 1.2 Amperes
4R4340: 0.6 Amperes
Greater than 1,000 VAC
2 Amperes, Type 3AG SB
24.1 ст H x 23.5 cm D x 31.1 cm W (91/2” x 91/4” x 121/4”)
8.5 kg (18.75 Ib)
40.68 MHz Nominal
3.9 mm (0.153”) Inside Diameter, 0.5 mm (0.02”) Wall Thickness
Three Wire SVT 18 Gauge (AWG) 2.4 m (8 ft) Long with Attached Molded Plug
0% to 95% Relative Humidity, Non-Condensing
30°F to 140°F
1.3 Accessories
A splash shield that mounts over the sealing head is available:
Code 4R4331 splash shield for Hematron® Dielectric Sealer, 100 units per case.

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2.0 Operation
This section contains instructions for the installation, operation and routine maintenance of the
Hematron® Dielectric Sealer. Read all instructions carefully before using the unit.
2.1 Unpacking
Each Hematron® Dielectric Sealer is shipped completely assembled and ready to operate. Inspect unit
immediately upon receipt and report any defects or damage to the freight carrier within 24 hours and your local
Fenwal representative.
2.2 Installation
Operation of the Hematron® Dielectric Sealer is controlled by three controls on the rear panel of the unit
(see Figure 2-1).
A 115/230 Voltage Selector Switch—Selects voltage corresponding to line output. On the 4R4330 this switch is
permanently set in the 115 VAC position.
B On/Off Power Switch—Controls AC power to unit.
C Heat Control—Adjusts RF power level to sealer head.
= e
Figure
2-1
Hematron®
Dielectric
Sealer,
Rear
View
Caution:
On
the
4R4340,
before
connecting
power
cord
to
electrical
outlet,
be
certain
that
the
115/230
Voltage
Selector
Switch
is
set
to
match
local
line
voltage.
The
switch
is
held
in
position
by
two
retaining
screws
and
a
guard.
To
change
the
switch
setting,
loosen
the
retaining
screws,
slide
the
switch
and
guard
to
new
position,
and
retighten
the
screws.

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2.3 Operating Instructions
Warning: This machine emits a low level of electromagnetic (nonionizing) radiation while sealing. It should not
be used or repaired by individuals with pacemakers. It should not be used near sensitive electronic equipment.
1. Set On/Off Power Switch to On. Illuminated pilot light on the sealing head indicates that power to the unit
is on.
2. Set Heat Control at 2 o'clock position.
Note: If line voltage is low [90 to 100 volts for 115 VAC nominal line (4R4330, 4R4340) or 180 to 200 volts for
230 VAC nominal line (4R4340)] rotate Heat Control fully clockwise.
3. Allow at least two minutes for Hematron® Dielectric Sealer to warm up before using.
4. Place Blood-Pack® Unit on top of Hematron® Dielectric Sealer. Wipe tubing dry if moisture is present.
5. Position tubing so that the x mark nearest the needle is between the sealing jaws. Gently depress tubing to
trigger the sealing process. Hold tubing in place until the sealing jaws open (see Figure 2-2).
Note: Opening of the sealing jaws indicates completion of the sealing process. The result is a hermetic seal of
the tubing. After waiting 3 or more seconds to allow the tubing to cool, segments can be separated at the seal
by twisting or snapping the tubing apart.
Caution: Do not touch sealing jaws during operation. A burn may result if direct skin contact is made while
sealing.
6. Move tubing to next x mark and repeat sealing process as required.
7. Turn off power to Hematron® Dielectric Sealer when it is not in use continuously.

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2.4
2.5
Routine Maintenance
The Hematron® Dielectric Sealer should be cleaned daily after use. If spills occur, the unit should immediately
be removed from service and cleaned completely before resuming use.
Caution: Blood and blood products should be treated as potentially infectious at all times. In the event of
blood spills, appropriate protective clothing should be worn during cleanup procedures. After removing residual
biological material, surfaces which have been in contact with blood or components should be disinfected using
a chemical germicide considered as a “sterilant” by the Environmental Protection Agency (EPA). Alternatively,
a freshly prepared solution of diluted sodium hypochlorite (household bleach) may be used to disinfect surfaces
which will not be harmed by the solution. Diluted solutions ranging from 1 part bleach in 10 parts water to
1 part bleach in 100 parts of water may be used. Regardless of the sterilant or disinfection solution used,
remember to remove any residue by rinsing with water (and drying) to ensure that surfaces of the equipment
are not subject to corrosion or discoloration. Discard all materials in contact with blood according to
institutional policies regarding disposal of biohazardous materials. (Reference: Recommendations for
Prevention of HIV Transmission in Health-Care Settings. Morbidity and Mortality Weekly Report (Supplement)
Volume 36, Number 25, August 21, 1987.)
Caution: Disconnect unit from power source before performing any maintenance procedure.
Sealer Head Cleaning
Caution: The Hematron® Dielectric Sealer is equipped with an external electromagnetic interference (EMI)
shield. To minimize the possibility of interference with other electronic devices, this shield must be in good
condition and properly installed whenever the Hematron® Dielectric Sealer is operated.
Access to the sealer head may be gained by removing the four thumbnuts and washers, which attach both the
clear plastic splash shield and the EMI shield to the cabinet, and removing the shields.
Note: Do not misplace the flat washers used with the thumbnuts. They must be used during reassembly
(see Figure 2-3).

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Figure
2-3
Splash
Shield
and
Electromagnetic
Interference
Shield
Removal

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1.
Clean
the
jaw
surfaces
of
the
sealer
head
gently
but
thoroughly
with
a
mild
detergent
or
70%
alcohol
solution
using
a
swab
or
small
stiff-bristled
brush
(see
Figure
2-4).
Wipe
the
jaws
completely
dry
with
a
cotton
swab
or
paper
towel.
Figure 2-4 Sealer Head Cleaning
2. If the sealer jaws have become pitted, clean them using #00 emery cloth. Sand the pitted surface in such a manner
as to remove the surface roughness, and clean any resulting debris from the sealer head according to the head
cleaning procedure.
3. Clean the splash shield with a mild detergent or 70% alcohol solution using a soft cloth. Use care with this shield, as
contact with abrasive materials will cloud or scratch the surface. Dry with a soft, lint-free cloth.
4. Inspect the sealer head EMI shield for surface contamination or corrosion. Contamination or mild corrosion should be
removed by using the cleaning methods outlined in the head cleaning procedure. Do not attempt to use abrasives to
remove contaminants as this will result in removal of the electroplated coating of the shield. If corrosion is present
that cannot be removed by cleaning, or if the shield has been broken, the shield should be replaced before the
Hematron® Dielectric Sealer is returned to service. Replacements may be ordered from the Fenwal Service Center.
5. After any necessary cleaning is completed, replace the EMI shield and splash shield and secure them with the four
thumbnuts. Be sure to use a flat washer under each thumbnut, and use only finger pressure when tightening them.
6. Clean cabinet surfaces periodically using a cloth moistened with water or a mild detergent. Do not allow liquid to flow
through the vent openings in the rear panel. Dry with a soft, lint-free cloth.

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2.6 FCC Requirements
The Hematron® Dielectric Sealer is designed and manufactured to comply with the rules of the United States
Federal Communications Commission (FCC), Title 47, Part 18 of the Code of Federal Regulations. It has been
prototype certificated to the FCC as complying with these regulations.

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3.0 Warranty and Service
3.1 Warranty
Baxter Healthcare Corporation, Fenwal Division, (Fenwal) warrants that the equipment shall be free from defects
in material and workmanship when delivered to the original purchaser. Fenwal’s sole obligation shall be limited
to repair or replacement, at Fenwal’s option and expense, of the defective part or unit for a period of
one (1) year following the date of initial delivery.
The warranty extends only to the original purchaser and is not assignable or transferable, and shall not apply to
auxiliary equipment, disposable accessories, or light sources.
FENWAL WARRANTS THAT THE EQUIPMENT IS FIT FOR THE PURPOSES AND INDICATIONS DESCRIBED IN
THE LABELING WHEN USED IN ACCORDANCE WITH THE DIRECTIONS FOR USE. UNLESS THE EQUIPMENT IS
USED IN ACCORDANCE WITH SUCH INSTRUCTIONS, THIS WARRANTY IS VOID AND OF NO EFFECT. NO
OTHER EXPRESSED OR IMPLIED WARRANTY EXISTS, INCLUDING ANY WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE. FENWAL’S SOLE OBLIGATION AND PURCHASERS EXCLUSIVE
REMEDY FOR BREACH OF WARRANTY SHALL BE LIMITED TO REPAIR OR REPLACEMENT AT FENWAL'S
OPTION. FENWAL SHALL NOT BE LIABLE FOR PROXIMATE, INCIDENTAL, OR CONSEQUENTIAL DAMAGES.
MODIFICATIONS, ALTERATIONS, RECALIBRATIONS OR ABUSE, AND SERVICE BY OTHER THAN A FENWAL
AUTHORIZED REPRESENTATIVE MAY VOID THE WARRANTY.
3.2 Service Information
While under Fenwal Warranty, the instrument must not be opened by unauthorized personnel.
All repairs must be done by qualified personnel only, and must follow procedures given in the Service Manual.
Contact Fenwal’s Product Service Division for service and repair information for all instruments. In USA call
[phone] (toll free) or in Illinois, [phone]. Outside of USA, contact your local Fenwal Product
Service Division representative.
Shipping cost for all units returned to Fenwal shall be paid by the customer. The unit must be packed in its
original container or in another Fenwal approved container that will provide adequate protection during
shipment. To ensure prompt return, a Fenwal Product Service Division representative must be notified before
shipping any unit for repair. When calling Fenwal’s Product Service Division, please be prepared to provide
code number and serial number of the unit. A service request number will be issued and should accompany all
communications. A brief written description of the problem should be attached to the instrument when it is
returned for service.
Fenwal Division will not be responsible for unauthorized returns or for units damaged in shipment due
to improper packing.
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