MACOSEAL twin

High Frequency Sealer

User Manual

en
 Table of Contents

WARNINGS AND CAUTIONS ................................................................. 2

1. SCOPE ................................................................................................. 3
1.1 INTRODUCTION...................................................................................... 3
1.2 PERFORMANCE AND SPECIFICATIONS ..................................................... 3
1.3 ACCESSORIES ...................................................................................... 9
1.4 SYMBOLS/MARKINGS DESCRIPTION ...................................................... 10
2. INSTALLATION ................................................................................. 11
2.1 UNPACKING AND INSPECTION ............................................................... 11
2.2 ENVIRONMENTAL REQUIREMENTS......................................................... 11
2.3 INSTALLATION PROCEDURE .................................................................. 11
2.4 INSTALLATION OF ADDITIONAL HAND UNIT ............................................. 11
3. FUNCTIONAL DESCRIPTION ........................................................... 12
3.1 DESCRIPTION OF SEALING ................................................................... 12
3.2 DESCRIPTION OF EQUIPMENT ............................................................... 12
4. OPERATING INSTRUCTIONS .......................................................... 13
4.1 PREPARATION BEFORE USE ................................................................. 13
4.2 HOW TO SEAL TUBES ........................................................................... 13
4.3 IF THE SEALER DOESN’T START ............................................................. 13
5. CLEANING ......................................................................................... 14
5.1 BASE UNIT ......................................................................................... 14
5.2 HAND UNIT ......................................................................................... 15
6. TROUBLESHOOTING ....................................................................... 17
6.1 BASE UNIT ......................................................................................... 17
6.2 HAND UNIT ......................................................................................... 17
7. WARRANTY AND SERVICE ............................................................. 18
7.1 W ARRANTY ........................................................................................ 18
7.2 SERVICE ............................................................................................ 18
8 LOCAL MACOPHARMA SALES/SERVICE OFFICE ......................... 19
Every effort has been made to ensure that the information in this document is
correct, but we make no guarantee to this effect and would appreciate any
observations regarding the contents of this document. We may make improvements
and alterations to the instrument and these changes will be incorporated in new
issues of this publication when practicable.
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1 MACOSEAL twin - Users Manual January 2011

 Warnings and Cautions
The general safety information in the manual is for operating personnel. Specific notes, cautions and warnings
may also be found throughout the manual where applicable. Please carefully read the User Manual before use.
Strictly follow the operating instructions whilst operating the sealer.

Note! This symbol identifies conditions that should be noted carefully.

Caution! This symbol identifies conditions that could result in damage to the equipment.
Warning! This symbol identifies conditions that could result in personal injury or loss of life.

Warning! MACOSEAL twin must be used in compliance with all specifications and operational procedures
listed in this manual.
Warning! MACOSEAL twin must be used under the continuous control of trained persons.
Warning! Please read the User Manual carefully before use.
Warning! Follow the operating instructions while operating MACOSEAL twin.

Warning! Cables and accessories others than those specified, may result in increased emission or
decreased immunity of the equipment or system.
Warning! The equipment or system should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the equipment or system should be observed to verify
normal operation in the configuration in which it will be used.
Warning! If any of the components of MACOSEAL twin are exposed to blood, they must be cleaned with
an appropriate disinfectant solution (see chapter five).
Warning! Disconnect MACOSEAL twin from power source before performing any maintenance and
cleaning procedure.

Warning! ELECTROMAGNETIC INTERFERENCE REGULATIONS

It should not be used near high frequency sensitive electronic equipment. See table 1, page 4, for
guidance.
Warning! Misuse or direct contact between tissue and RF electrode can result in severe RF burns.
Warning! MACOSEAL twin uses radio frequency (RF) energy to generate heat for sealing. Users are
requested to be cautious of potential electrical shocks or hazards while handling this sealer.
When the hand unit is connected to the mains power, always keep your fingers away from the
electrodes in the slot. Never place any object other than the PVC tube between the electrodes.

Caution! ELECTROMAGNETIC INTERFERENCE REGULATIONS

This equipment fulfils EN/IEC 60601-1-2:2007 Standards (Electromagnetic Compatibility).
Nevertheless this equipment uses radio-frequency (RF) energy to generate heat while the tube is
being sealed and can affect other Medical Electrical Equipment. See table 1, page 4, for
guidance. If installation and use is not performed in accordance with this manual, it could cause
interference to radio, television and instruments.

Caution! Portable and mobile RF communication equipment can affect MEDICAL ELECTRICAL
EQUIPMENT, See table 2, 4 and 6, page 4 - 6, for guidance.
Caution! Inspect all parts of the instrument for the appearance of defects before use.
Caution! To guarantee the safe use, only accessories delivered with MACOSEAL twin can be used.

Caution! If multiple seals are made along a length of tubing they should be at least 1/2 inch (1 cm) apart.
Multiple seals made closer than the recommended distance may result in rupture of the sealed
tubing segment
Caution! In case of sealer malfunction (intermittent operation, poor quality seals, sealing time seems too
long or too short) call the technical service for assistance.
Caution! Periodically check the pattern of the sealing visually (see section 4.2)

Note! Contact MacoPharma Technical Services for the disposal of the MACOSEAL twin (and
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accessories) at the end of its useful life.

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1. Scope
This chapter contains a description and specifications of the MACOSEAL twin tube sealer from MacoPharma.

1.1 Introduction
MACOSEAL twin is a fully automatic system for sealing PVC tubes, especially tubes in blood pack systems. After
the sealing procedure, the tube is easily pulled apart due to the distinct sealing pattern, with no damage to the
blood inside the tubes.

The base unit is connected by the cable to the hand unit, where the sealing takes place when the trigger is
pressed. Different types and sizes of tubes can be used, and the necessary sealing time is self-adaptive to fit the
tubes that are being used.

MACOSEAL twin uses radio frequency (RF) energy to generate heat for sealing. Users are requested to be
cautious of potential electrical shocks or hazards while handling this sealer. When the hand unit is connected to
the base unit, always keep your fingers away from the electrodes in the slot. Never place any object other than
the PVC tube between the electrodes.

1.2 Performance and Specifications

The table below lists the technical specifications:
Parameter Value/ Description
9MSL3620

Type No. M 36200-00

Intended Use The MACOSEAL twin is a fully automatic system for sealing PVC tubes included in blood pack systems
or Apheresis Disposable Sets. The sealing can be performed when donor is still connected to the Blood
Pack or Apheresis Set
Tube specification: 2.5 to 5.0 mm outer diameter
PVC@20°C maximum 0.75 mm wall thickness
Sealing time: 0. 4 – 1.5 s, max 6 s, depending on tube size and type.
Seal procedures: 800 per hour.
Continuous seal capacity: 100
Mode of operation: Operation: 25% Intermittens: 75%

Input Power: 100 - 230 V ~ 50-60 Hz

Consumption: 400VA
Fuses: 2 x T4 AL, 250 V internal
RF Output: 90 W max. / 40.68 MHz
Size mm: Base unit: 232 / 91 / 91
Weight kg : Base unit: 2.1 Hand unit: 0.32
Temperature: Operating: 4 to 35 °C (39 – 95 °F) Storage: – 20 up to + 70 °C (-4 – 158 °F)
Humidity: Operating: 10 up to 90% Rh (non-condensing) Storage: 10 up to 90% Rh (non-condensing)
In compliance with: - EN 60601-1, UL 60601-1 and CSA C22.2#601.1 General requirements for basic safety and essential
perfomance
- EN/IEC 60601-1-2: Collateral standard for Electromagnetic compatibility
Electrical safety: Class I (EN 60601-1 Stds)
The MACOSEAL twin is used in the same environment as medical equipment (hospitals and blood
banks) and must be used by highly trained personnel
Manufacturer according to MacoPharma
MDD: Rue Lorthiois
59420 Mouvaux
FRANCE
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 Table 1:

Guidance and Manufacturer’s Declaration – Electromagnetic Emission

The MACOSEAL twin tube sealer is intended for use in the electromagnetic environment specified
below. The customer or the user of the MACOSEAL twin should assure that it is used in such an
environment.
Emission Test Compliance Electromagnetic Environment - Guidance
The 36200-00 must emit electromagnetic energy in
RF emission Group2
order to perform its intended function. Nearby electronic
CISPR 11
equipment may be affected.
RF emission
Class B The 36200-00 is suitable for use in all establishments,
CISPR 11
including domestic establishments and those directly
Harmonic emission Class A
connected to the public low-voltage power supply
IEC 61000-3-2
network that supplies buildings used for domestic
Voltage fluctuations/ Complies
purposes.
Flicker emissions
IEC 61000-3-3

Table 2:

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The MACOSEAL twin is intended for use in the electromagnetic environment specified below. The
customer or the user of the MACOSEAL twin should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Compliance Electromagnetic Environment -
Level Guidance
Electrostatic ± 6kV contact 6kV contact Floors should be wood, concrete or
discharge (ESD) ceramic tile. If floors are covered with
± 8kV air 8kV air synthetic material, the relative
IEC 61000-4-2 humidity should be at least 30%.
Electrical fast ± 2kV for power 2kV for power Mains power quality should be that of
transient/burst supply lines supply lines a typical commercial or hospital
environment.
IEC 61000-4-4 ± 1kV for input/output
lines Not applicable
Surge ± 1kV line(s) to 1kV differential Mains power quality should be that of
line(s) mode a typical commercial or hospital
IEC 61000-4-5 environment.
± 2kV line(s) to earth 2kV common
mode
Voltage dips, short < 5% Uτ < 5% Uτ Mains power quality should be that of
interruptions and (> 95% dip in Uτ) (> 95% dip in Uτ) a typical commercial or hospital
voltage variations on for 0.5 cycle for 0.5 cycle environment. If the user of the
power supply input 36200-00 requires continued
lines 40% Uτ 40% Uτ operation during power mains
(60% dip in Uτ) (60% dip in Uτ) interruption, it is recommended that
IEC 61000-4-11 for 5 cycles for 5 cycles the 36200-00 be powered from an
uninterruptible power supply.
70% Uτ 70% Uτ
(30% dip in Uτ) (30% dip in Uτ)
for 25 cycles for 25 cycles

< 5% Uτ < 5% Uτ
(> 95% dip in Uτ) (> 95% dip in Uτ)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
(50/60 Hz) magnetic should be at levels characteristic of a
field typical location in a typical
commercial or hospital environment
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IEC 61000-4-8
NOTE Uτ is the a.c. mains voltage prior to application of the test level.

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Table 4

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The MACOSEAL twin is intended for use in the electromagnetic environment specified below. The
customer or the user of the MACOSEAL twin should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Electromagnetic Environment -
Level Guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the 36200-00 including cables
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter

Recommended separation
distance
Conducted RF 3 Vrms 3V d = 1.17 √P
IEC 61000-4-6 150 kHz to 80 MHz

Radiated RF 3 V/m 3 V/m d = 1.17 √P 80 MHz to 800 MHz

IEC 61000-4-3 80 MHz to 2.5 GHz
d = 2.33 √P 800 MHz to 2.5 GHz

Where P is the maximum output power

rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m)

Field strengths from fixed RF transmitters,

as determined by an electromagnetic site
a
survey, should be less than the
compliance level in each frequency
b
range.

Interference may occur in the vicinity of

equipment marked with the following
symbol:

NOTE 1 At 80MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the 36200-00 is used exceeds the applicable RF compliance level above, it should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the 36200-00.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m
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5 MACOSEAL twin - Users Manual January 2011

 Table 6:

Recommended Separation Distance between Portable and Mobile RF Communications Equipment

and the MACOSEAL twin
The MACOSEAL twin is intended for use in the electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the MACOSEAL twin can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the MACOSEAL twin as recommended below, according to
the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter
output power of m
transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz
800 MHz to 2,5 GHz
W d = 1.17 √P d = 1.17 √P
d = 2.33 √P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 11.7 11.7 23.3
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer

NOTE 1 At 80MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
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January, 2011 MACOSEAL twin - Users Manual 6

 Multicolour LED indicator

Handle connectors

Front view of the Base unit

Power Switch

Power Inlet

Type Label

Rear view of the Base unit

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7 MACOSEAL twin - Users Manual January 2011

 Multicolour LED indicator
Sealing electrodes

Release lock.
(One on each side)

View of the Hand unit

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1.3 Accessories
MACOSEAL twin comprises the items listed below.

Base unit (Type 36200-00) + Additional hand unit

Description Hand unit (Type 36300-00) + (Type 36300-00) can be
Power cable ordered seperately
9MSL3620 9MSL3630

Additional Accessories (to be ordered separately)

Description Hard MacoSeal Twin Case

9MSL3623

List of all cable and maximum lengths of cable, transducers and other accessories with which the manufacturer
claims compliance (cables, accessories used other than those listed may impact emission/immunity)

Item Specification
9 362 98100 Europe (supplied as Three-wire (10A), 2.5 m long (8ft), female plug
Power cable
standard)

Power cables to be supplied locally

USA Three-wire (10A), 3.0 m long (10ft), Hospital
Power cable
grade plug
Power cable UK Three-wire (10A), 2.5 m long (8ft), female plug
Power cable Australia and New Zealand Three-wire (10A), 2.5 m long (8ft), female plug MACOSEAL_UME_04

9 MACOSEAL twin - Users Manual January 2011

 1.4 Symbols/Markings Description
Symbols on equipment + labels
This marking reflects compliance with the Council Directive 93/42/EEC on Medical
Devices.
This marking reflects compliance with UL 60601-1 and CSA C22.2 #601.1 for USA and
Canadian markets
Caution

Symbol for “Consult User MANUAL”.

Symbol for “ CATALOGUE NUMBER “.

Symbol for “ SERIAL NUMBER “.

Symbol for “ DATE OF MANUFACTURE “.

Symbol for “MANUFACTURER”

Symbol for “NON-IONIZING RADIATION”.

Symbol (WEEE 2002/96/EC)

Do not dispose Product as municipal waste. Collect Product separately. Use collection
and return systems available to you.
th
Product brought to EU market after August 13 , 2005

Marking on the 2 items of MACOSEAL twin

Base unit - Multicolour LED, indicates Green at normal power, Orange during seal, Red during
error indication.
- Indicator lights red (fast blink) during one second in case of short circuit, sealing
function is blocked.
- Indicator lights red (slow blink) once a second in case of over heating, sealing function
is blocked.
- Type and serial number.

Hand unit - Multicolour LED, indicates Green at normal power, Orange during seal, Red during
error indication.
- Indicator lights red (fast blink) during one second in case of short circuit, sealing
function is blocked.
- Indicator lights red (slow blink) once a second in case of over heating, sealing function
is blocked.
- Type and serial number.
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2. Installation
This chapter involves unpacking, temperature requirements and installation of the instrument.

2.1 Unpacking and Inspection

1. Visually inspect the cardboard box for damage, report any damage immediately.
2. Lift the instrument out of the cardboard box and place it on a flat surface.
The instrument is shipped in one cardboard box which includes:
1 Hand unit. 1 Base unit. 1 Mains cable 1 Manual (English)
If you need help identifying these parts, see chapter 1.3 (“Accessories”).

3. The above list is subject to change, refer to the packing list for accurate description of contents.
If parts are missing or if parts are damaged, report it immediately.
4. Please keep all shipping and packaging materials, as they may be required for later transportation, at least
during the warranty period.

2.2 Environmental Requirements

To keep the Instrument operating at its best, please observe the following:
1. The instrument should be placed on a flat surface free from dust, solvents and acidic vapour.
2. Use the instrument within an ambient temperature of 4 - 35°C (39 - 95°F), and relative humidity 10% - 90%
non- condensing.
3. Handle the components with care in a clean environment.

2.3 Installation Procedure

Connect the delivered hand unit as follows:

1. Connect the handle cable, blue at end of cable, to one of the connectors on the base unit front.
Make sure connector snaps in secured position.
2. Insert the power cable into the power entry module on the back panel of the base unit.
3. Plug the power cable into an alternating current outlet.
4. Perform a test seal on an empty or water filled tube to ensure proper operation.

Warning! The instrument must always be connected to an outlet with protected ground and from appropriate
alternating current mains source, 100 to 230 V ~.

Caution! Ensure that all cables are connected before turning the power on.

2.4 Installation of Additional Hand Unit

If an additional hand unit is to be connected to the base unit ensure that the power switch is turned off. Only an
additional hand unit type MACOSEAL twin (blue at end of cable) can be attached.

1. Connect the handle cable, blue at end of cable, to the available connector on the base unit front.
Make sure connector snaps in secured position.
2. Perform a test seal on an empty or water filled tube to ensure proper operation.

Warning! Ensure that the power switch is turned off before installing additional handle.
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11 MACOSEAL twin - Users Manual January 2011

 3. Functional Description
This chapter describes the sealer equipment and its function.

3.1 Description of Sealing

The tube to be sealed is placed in the slot of the hand unit. When the user presses the blue trigger on the hand
unit, the tube is pressed together and the sealing procedure will start automatically. The radio frequency (RF) -
generator starts and the energy is transferred from the electrode to the tube, which melts to a sterile welding
pattern.

During the whole sealing process, a light on the front of the hand unit lights orange. When this light goes to
green, the blue trigger may be released, and the sealing is complete. The intelligent sense control in the unit
detects controls and adjusts the sealing process to give the best sealing quality for the type of tubes that are
being used.
See description in section 1.4 for the different light indications on the units in case of problem.

3.2 Description of Equipment

MACOSEAL twin mainly consists of a base unit, hand unit(s) with interconnection cable. Below is a short
description of each component:

The Hand unit consists of ergonomic handgrip with trigger and electrode (which can be removed for cleaning).
The handle has integrated cable for connection to base unit.

The Base unit consists of the power supply module and RF-generator module with control circuits.
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4. Operating Instructions
This chapter describes the use of the instrument.

Caution! Inspect all parts of the instrument for the appearance of defects before use.

Warning! This equipment emits a low level of electromagnetic (non-ionizing) radiation while sealing.
Misuse or direct contact between tissue and RF electrode can result in severe RF burns.
It should not be used near high frequency sensitive electronic equipment.

4.1 Preparation before Use

1. Place the instrument on a flat surface near the working place.
2. Connect the cables according to chapter 2.3 and 2.4.
3. Check that the LED lights green when you turn the power switch on.
Caution! MACOSEAL twin uses radio frequency (RF) energy to generate heat for sealing. Users are requested
to be cautious of potential electrical shocks or hazards while handling this sealer. When a unit is
connected to the power, always keep your fingers away from the electrodes in the slot. Never place
any object other than the PVC tube between the electrodes.

4.2 How to seal tubes

Note! The tube must be dry on the outside.

1. Put the tube to be sealed down to the bottom of the slot of the hand unit.
2. Check that the tube is placed between the electrodes in the slot.
3. Press the trigger to bring the two electrodes closer together until the orange light on front of the handle
comes on.
The sealing time is normally 0.4 to 1.5 seconds; after maximum of 6 seconds the RF is turned off.

Note! Do not pull the tube and keep the trigger fully pressed down until the orange light changes to
green.

4. When the orange light switches to green, sealing is finished, then release the trigger and remove the tubing.
5. The centre of the sealed pattern is very thin and pulling both sides will divide the tube into two pieces.

Note! If the user releases the seal button at any time, the sealing process stops.
Caution! If multiple seals are made along a length of tubing they should be at least 1cm (½ inch) apart.
Multiple seals made closer than the recommended distance may result in rupture of the sealed tubing
segment.
Caution! In case of sealer malfunction (intermittent operation, poor seals quality) call the technical service for
assistance.
Caution! If the sealing time seems too long or too short, call the technical service for assistance.
Caution! Periodically check the pattern of the sealing visually (see picture below).

Good Sealing Pattern Bad Sealing Pattern

4.3 If the sealer doesn’t start

The sealer has several safety functions which, before sealing, control and identify whether or not it is possible to
seal the tube. The table below covers the common probable causes for problems and suggests some corrective
actions.

Probable cause Recommended action

Wet tube (fast red blink). Dry the tube and electrodes and try again.
Tiny arcs between the electrodes (fast red blink). Dry the electrodes and try again.
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Over heated (slow red blink). Let the unit cool down until the green light comes on.
If the sealer still doesn’t start, see chapter 6, for further information.

13 MACOSEAL twin - Users Manual January 2011

 5. Cleaning
This chapter gives information on the cleaning (procedure, periodicity) of the base unit and hand unit.
The sealer requires minimal maintenance for efficient operation.
Follow the cleaning procedure below.

Warning! For you own safety always turn off the power switch and disconnect the Power cable.
It is advisable to wear medical gloves for cleaning drops of blood.

Caution! Blood and blood products must be treated as potentially infectious at all times. In the event of blood
spillages, appropriate protective clothing should be worn during clean-up procedures. After removing
residual biological material, surfaces which have been in contact with blood or components must be
disinfected using a chemical agent considered as a "sterilant" (e.g. isopropanol 70%). 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 from 1 part bleach to 10 parts
water may be used. Regardless of the “sterilant” or disinfection solution used, remember to remove
any residue to ensure that the surfaces of the equipment are not subject to corrosion or discoloration.
Discard all materials in contact with blood according to institutional policies regarding the disposal of
biohazardous materials.

Caution! Do not disinfect or sterilize any part of the sealer through autoclave or with ethylene oxide
gas, to do so will render the sealer unusable and invalidate the warranty.
Do not use chemical or abrasive cleaners such as acetone, ammonia or similar.
Do not use sharp edged tools for cleaning, which could damage the finish of the units.

Caution! Disconnect hand unit from base unit before performing any cleaning procedure.

Caution! Do not allow liquid to flow in the electronic part of the equipment.

5.1 Base Unit

It is recommended to clean the base unit once per month, except if blood spillage occurs. Then the unit must
immediately be removed from service and cleaned completely before resuming use. To clean the outside of the
base unit, use a soft lintfree cloth moistened with mild detergent. Do not, under any circumstances, submerse the
base unit in any kind of liquid. This will damage the unit and void the warranty.
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5.2 Hand Unit
Cleaning the hand unit is required if blood spillage occurs. Otherwise it is recommended to clean once per
month.

For cleaning the electrodes, remove the trigger with electrode.

Removal of trigger with electrode:

Figure 1

Lock

Lock

Figure 2 Figure 3

Figure 4

1. Close trigger until electrodes meet (not .

further), fig. 1
2. Push the blue locks (using ballpoint pen or
similar) on each side till “click”, fig 2 and 3
3. Pull forward trigger with electrode fig 4.

Clean the hand unit and both electrodes with a soft lintfree cloth moistened with mild detergent.
The removed trigger with electrode can be washed under tap water.
Dry carefully and ensure that the electrodes are completely dry to prevent sparks.
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After cleaning, inspect the electrodes for any mechanical damage or wear out.
Do not use damaged part.

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 Assembly of handle and trigger with electrode:

Figure 5 Figure 6

Locking Locks in
point (one place (one on
on each each side)

Figure 7 Figure 8
1. Place the trigger with electrode onto the
handle, ensure that the trigger is close to the
handle, see Fig 5
2. Make sure that the electrode is positioned so
as to be parallel with the fixed electrode and
aligned with the corresponding cut-in portion
on the handle, see fig 6.
3. Pull the trigger with electrode back on to the
handle until the locks on each side “click” fig 7
and fig 8
4. Press the trigger twice and ensure that the
electrode moves smoothly, is in position and
not loose.

Note! It is recommended to perform some sealing tests before resuming use.

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6. Troubleshooting
User level maintenance is limited to changing base unit or hand unit. The following information covers common
problems and offers suggested solutions.
6.1 Base Unit
LED doesn't light green
LED lights green but when the
trigger is pressed the
LED doesn’t light orange
LED blink slow red
LED does not light or does not
light at the same time as the
LED on the Hand Unit
6.2 Hand Unit
Symptom
The sealing doesn’t start.
Bad sealing.
Hard to divide tube after seal
Intermittent sealing.
LED lights orange after the trigger
has been released.
LED doesn’t light.
17
No Voltage. Check Power Supply and cable.
Power switch off Check power switch.
Internal Fuse blown. Seek MacoPharma technical service for
assistance.
Other cause. Seek MacoPharma technical service for
assistance.
No connection Check cableconnection.
Hand unit inoperative. Change Hand unit or seek MacoPharma
technical service for assistance.
Other cause. Seek MacoPharma technical service for
assistance.
The base unit is too hot. Wait (10 min.) until the LED turns green.
base unit inoperative. Seek MacoPharma technical service for
assistance.
Probable cause Recommended action
Wet electrodes. Dry the electrodes, see chapter 5.2.
Cable broken. Seek MacoPharma technical service for
assistance.
Other cause. Seek MacoPharma technical service for
assistance.
Active electrode doesn’t move Seek MacoPharma technical service for
smoothly on handle. assistance.
Rim on active electrode Change hand unit or seek MacoPharma
damaged. technical service for assistance.
Other cause. Seek MacoPharma technical service for
assistance.
Cable broken. Seek MacoPharma technical service for
assistance.
Other cause. Seek MacoPharma technical service for
assistance.
Hand unit defective. Seek MacoPharma technical service for
assistance.
Hand unit defective. Seek MacoPharma technical service for
assistance.
Cable broken. Seek MacoPharma technical service for
assistance.
Other cause. Seek MacoPharma technical service for
assistance.
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 7. Warranty and Service
Information on the warranty and the service provided by MacoPharma is listed below:

7.1 Warranty
MacoPharma warrants that the equipment shall be free from defects in material and workmanship when delivered to the
original purchaser. MacoPharma’s sole obligation shall be limited to the repair or replacement, at MacoPharma’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, or disposable accessories.

MacoPharma 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 these 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. MacoPharma’s sole obligation and purchaser’s exclusive remedy for breach of warranty shall be limited
to the repair or replacement at MacoPharma’s option. MacoPharma shall not be liable for proximate, incidental or
consequential damages. Modifications, alterations, recalibrations or abuse, and service by other than a MacoPharma
authorized representative will void the warranty.

7.2 Service
Service under warranty period
While under MacoPharma warranty, the instrument must not be opened by unauthorized personnel.
Contact MacoPharmaTechnical Service for service and repair information for all MACOSEAL twin instruments.

Shipping costs for all units returned to MacoPharma shall be paid by the customer. The unit must be packed in its original
box or in another MacoPharma approved box that will provide adequate protection during shipment. To ensure prompt
return, a MacoPharmaTechnical Service representative must be notified before shipping any unit for repair. When calling
MacoPharma Technical Service, please be prepared to provide part 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. MacoPharma will not be responsible for unauthorized returns or for
units damaged in shipment due to improper packing.
Service after warranty period
After MacoPharma warranty period, the MACOSEAL twin will continue to be serviced by MacoPharmaTechnical Service.

If the instrument has been purchased by thecustomer, he/she will have the choice, either to have the service ensured by
MacoPharma Technical Service, or to perform it themselves. Please contact MacoPharma Technical Service to dispose of
the instrument.

If customers want to perform the service themselves, MacoPharma Technical Service will make available on request the
service manual including non confidential information (as block diagrams, component part lists, descriptions, calibration
instructions), periodic preventive maintenance guide, and any other non confidential information which will assist the
customer’s appropriately qualified technical personnel to repair those parts of equipment which are designated by the
manufacturer as repairable.

Product Disposal
For MACOSEAL twin disposal, please ensure the following:
• Do not dispose MACOSEAL twin as unsorted municipal waste.
• Collect the MACOSEAL twin separately.
• Use the collection and return systems available to you.
For more information on return, recovery or recycling of MACOSEAL twin, please contact your local MacoPharma
representative.
Preventive Inspection and Maintenance
At least every second year, the MACOSEAL twin must be fully inspected by:
- either the qualified service organization of the customer,
- or by MacoPharma Technical Service.
Interchangeable Parts Replacement (User level maintenance)
User level maintenance is limited to changing base unit or hand unit.
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January, 2011 MACOSEAL twin - Users Manual 18

8 Local MacoPharma Sales/Service Office

Local Sales/Service Office

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19 MACOSEAL twin - Users Manual January 2011

Rev. Nov. 2007 = New.
Rev MPJuly. 2009 = New handle cable.
Rev June 2010 = Editorial corrections, adapted to cover only MACOSEAL twin and new pictures
Rev October 2010 = New accessory added, ETL label changed, 2 spelling mistakes corrected, new logo
Rev November = new cleaning instructions, more pictures inserted, ETL mark removed unit approval received
Rev January 2011 = Type no. corrected, warning changed to caution.
Rev January 2011 = Distrubuted removed front page, symbols for Ref and SN inserted, etl mark inserted,
improved quality of 2 symbols in table, UL and CSA inserted, new picture rear view of base unit
Rev January 2011 = Manual ref added to all pages, part no. replaced with REF, new type label, new picture
rear view base unit

Print only manual pages 0 - 19

January, 2011 MACOSEAL twin - Users Manual 20