This machine is part of the GIMA product range. Thanks to our modern production, assembly
and testing methods and many years of experience GIMA machines satisfy the highest quality
requirements.
This user manual includes:
• Safety instructions
• Instructions for installation and use
• Instructions for maintenance and repair
• Troubleshooting
• Technical data
• Declaration(s)
Using this manual will:
• Make it easier to get used to working with the machine
• Prevent malfunctions caused by non-professional use
Please observe the maintenance instructions, as they will:
• Enhance the machine’s reliability
• Extend the machine’s service life
• Reduce the costs of repair and shutdown of operations
GIMA will not accept liability for damage to this machine if:
• The machine is not operated in accordance with the instructions presented in this user
manual.
• The machine is used for any purpose other than that specified in this user manual. (see safety
instructions).
The guarantee expires in the event of:
• Faulty operation
• Failure in the scheduled maintenance
• Deviating dimensions
CAUTION!
The user manual should always be kept in the direct vicinity of the machine.
Only operate the machine after careful study of the user manual.
Please observe the safety instructions and instructions for preventing accidents under all
circumstances.
If you need to use spare parts, use only original GIMA parts for your own safety.
This GIMA machine was built in accordance with current technical rules and regulations.
D 301 Evo rev.1.0
Symbols in the user manual:
CAUTION: danger
CAUTION: specific warning
CAUTION: maintenance advice
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D 301 Evo rev.1.0
personal injury and considerable damage.
authorised to operate the machine.
work in accordance with the manual.
perform these tasks as specified in the relevant sections of the manual.
The user
This manual is meant to be used by different users. However, all operators must observe the
following restrictions.
Operation of the machine by untrained personnel could lead to serious
GIMA cannot be held liable for damage caused by individuals not
Operating personnel
Operating personnel must be trained, through a training programme or by the operator, to
perform the designated tasks and be aware of the consequences that can arise from use by
untrained individuals. The machine may not be operated by persons under the influence of
alcohol medicines and/or drugs.
Installation, maintenance and repairs require specialist training and may only be carried out by
maintenance personnel.
If in doubt about the correct operation of the machine, consult maintenance
personnel immediately.
Maintenance personnel
Based on professional training, knowledge and experience and the applicable regulations set
down by the manufacturer, maintenance personnel has been trained to carry out the designated
tasks and identify potentially dangerous situations independently.
When working on the machine, all maintenance personnel are obligated to
All specialist work is to be performed exclusively by persons authorised to
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D 301 Evo rev.1.0
All rights reserved. Nothing from this edition is allowed to be copied and/or made public by means of print, photo copy or any other way without
previous written permission of GIMA .
GIMA reserves the right to change spare parts and/or specifications without previous notice. Contents of this manual can also be changed
without previous warning.
GIMA cannot be hold responsible for eventual damage caused by specifications deviating from the standard model.
Although extreme care has been exercised during writing this manual, GIMA will not accept any liability for eventual errors in this manual
and/or for the consequences of (mis)interpretation of the contents.
GIMA is not responsible for damage or problems which result from the use of other than the original spare parts. If this manual has not been
supplied with instructions for certain repairs, adjustments and maintenance, you should contact your dealer of GIMA .
While unpacking the machine, use the following list to check if everything is present.
• The machine
• User manual
• Power supply cable
• Left and right foil roll holder
• Foil roll
• Foil guides (4x)
• Work table
• Bag containing:
• Hex key
• Phillips screwdriver
• Fasteners
• Covers (2x)
Check the data on the identification plate. (see fig. 1) near the power port and copy them to the
following figure.
The packaging materials used for this machine are environmentally friendly and can be disposed
of as regular household waste. We recommend keeping the packaging, so that the machine can
be transported safely if required in the future.
2 Safety instructions and precautions
Please read the user manual carefully before operating the machine!
Explanation of the warning icons:
A. Caution: hot parts on the inside of the
machine
Safety markings on the machine:
The safety markings are complete and have been applied to the machine in such a way that they
are easy to read. Please replace any damaged and illegible safety markings.
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D 301 Evo rev.1.0
specifically to that environment.
the packaging of medical instruments.
The machine can be dangerous for persons and objects if:
• The machine was not installed in accordance with the instructions;
• The machine has been placed in an unsuitable environment;
• The machine is not used properly;
• The machine has been modified or adapted in any way;
• The users do not meet the requirements;
• The safety instructions are not observed.
Remaining risks that cannot be avoided through technical adjustments:
• When feeding the foil into the machine fingers can get trapped under the seal bar. Be certain
to remove your fingers from underneath before closing the seal bar with the operating lever.
• When feeding the foil into the machine your fingers may come into contact with the seal bar.
Do not touch the seal bar, as this may cause serious burns.
• Be careful not to touch the cutter blade during maintenance operations, as this may cause
serious injury.
• Beware of the danger of an electric shock. Your fingers may come into contact with
electrically charged parts during maintenance operations. Always switch off the machine and
disconnect it from the main power supply before carrying out maintenance operations.
Of course, the following apply as well:
• The relevant safety regulations to prevent accidents;
• The general safety instructions;
• Any applicable local or regional regulations.
Making alterations and adjustments to the machine:
• If any alterations or adjustments are made to the machine by unauthorised personnel, GIMA
will no longer be able to guarantee the operational safety of the machine.
• GIMA does not accept liability for any parts or special components not supplied by GIMA
(or any other goods not manufactured by GIMA ).
• The assembly and/or installation of these articles could have a detrimental effect on the
passive safety of the machine.
• GIMA is not liable for damage caused by any components other than the original
components supplied by GIMA .
Using the machine for any special applications:
If the machine is used in a medically sterile environment and/or clean room,
the operator is responsible for compliance with the regulations that apply
If the machine is used for the packaging of medical instruments, the operator
is responsible for compliance with the regulations that apply specifically to
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D 301 Evo rev.1.0
SWITCHING ON THE MACHINE
Before switching on the machine:
The user must be thoroughly familiar with the equipment, working method
and operating elements of the machine.
All operators are required to use personal protective equipment.
Please ensure the following points are in order before switching on the machine:
• The data on the identification plate corresponds with the voltage (V), frequency (Hz) and the
power rating (W) of the local power supply.
• The machine does not have any notable defects.
• The operating elements all function properly.
• No foreign objects have been placed in or on the machine.
If the above points are not in order, the machine may NOT be switched on.
Working with the machine:
•Use only sealable materials that are suitable for the machine. (See capitel Fout!
Verwijzingsbron niet gevonden.)
• Never open the cover of the machine while it is still connected to the power supply.
• If there is any doubt about the proper functioning of the machine, immediately disconnect the
machine from the main power supply and consult maintenance personnel.
• Both the operator and the machine must be supervised throughout the operating process.
• In the event of a malfunction, do not operate the machine until the fault has been completely
repaired.
• If any liquid is spilled onto the machine or an object falls into the machine, switch off the
machine and immediately disconnect the machine from the main power supply. Have the
machine checked by maintenance personnel before using it again.
• In the event of an unusual alarm, such as smoke emanating from the machine, switch off the
machine and immediately disconnect the machine from the main power supply. Have the
machine checked by maintenance personnel before using it again.
When working with the machine, the seal bars will be hot and can cause
serious burns if they come into contact with the skin.
The machine is equipped with a sharp blade. This can cause serious injury.
9
D 301 Evo rev.1.0
injuries.
In case of fire:
Never douse the machine with water if it catches fire. The machine is connected to the power
mains, so this could cause a life-threatening situation. A fire extinguisher must be kept within
reach of the machine at all times. The following types of fire extinguisher can be used to
extinguish the machine:
• Powder extinguisher
• Foam extinguisher
Switching off the machine:
• Switch off the machine when it is not in use.
• If the machine will not be used for a long period of time, disconnect the machine from the
main power supply.
Maintenance and repairs:
• Maintenance and repairs to the machine require specialist training and may only be carried
out by authorised maintenance personnel.
• Unauthorised persons may not perform maintenance tasks.
• Switch off the machine and disconnect it from the main power supply before carrying out
maintenance operations.
• Do not clean the machine with water, abrasives, chemical solvents or other fluids.
The machine contains high voltage parts, which may cause electric shock or
serious personal injury.
The machine contains hazardous moving parts, which may cause serious
personal injury.
When performing maintenance tasks or repairs, remember that the seal bars
are still hot immediately after use. Touching these can cause serious burn
Maintenance work on the electrical wiring:
Switch off the machine and disconnect it from the main power supply before carrying out
maintenance operations to the electrical wiring. Be absolutely certain that there is no power
supply to the machine. Place a warning sign on the machine to ensure that no one switches it on.
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D 301 Evo rev.1.0
3 General description
The D 301 Evo is a heat sealer for the packaging of medical instruments in laminated foil. After
the instruments have been placed in a bag, the bag is sealed. The bag is placed under the seal bar,
which is closed by manually pulling down the operating lever. This causes the seal bar to shut,
sealing the bag in just a few seconds. Once the bag has been sealed, the instruments in the sealed
bags can be sterilised in a steam autoclave.
The D 301 Evo is easy to operate. After the machine has been switched on, the seal bar will start
heating to the standard sealing temperature. This takes only a few minutes. The machine will
start sealing immediately after the seal bar has been lowered by means of the operating lever.
After 4 seconds the on/off switch will start to blink and the sealer will emit a sound signal. The
machine switches off automatically if it is not used for 30 minutes.
The D 301 Evo uses prefabricated plastic bags as well as rolls of laminated foil. Plastic bags can
be made to measure from this foil, which can be cut to the dimensions of your choice with the
machine’s integrated cutter. The machine seals bags in all foil widths, up to the maximum width
of the seal bar.
The machine can seal laminated foil and/or plastic bags that are suitable for steam sterilisation.
Sealing cycle
The complete sealing cycle of the machine comprises the following steps:
• Insert the laminated foil bag into the machine under the seal.
• Pull the operating lever to close the seal bar.
• Cut off the excess foil above the seal by sliding the cutter back and forth.
• After 4 seconds the on/off switch will start to blink and the machine will emit a sound signal.
The seal is ready.
• Open the seal bar and take the bag out of the machine. Your packaged instruments can now
be sterilised in a steam autoclave.
The D 301 EVO Evo can only seal laminated foil and/or plastic bags that can
withstand steam sterilisation.
- Extraction, ventilation:Use in a ventilated room
5.2 Non-permitted applications
- Use in an explosive environment
- Use in a freezer/walk-in refrigerator
- Packaging of toxic, corrosive or irritating substances
- Packaging of explosive materials
- Packaging of toxic, suffocating or irritating gases
- Packaging of hazardous dustlike products
12
D 301 Evo rev.1.0
fig. 3Mounting the spindle to the work table
6 Installation
The machine may only be installed by authorised maintenance personnel.
(see foreword).
Installing the machine under unauthorised circumstances may cause lasting
damage to some of its components.
All operators are required to use personal protective equipment.
Make sure that there is enough space around the machine to ensure its safe
operation, maintenance and repairs.
6.1 Installation
Place the machine in a ventilated, well-lit room. Make sure that the machine is not exposed to
direct sunlight, extreme temperatures, moisture, dust or sand. The machine must not be exposed
to mechanical shocks or vibrations.
Place the machine on a sturdy, flat surface to ensure optimum stability.
6.1.1 Installation with a spindle
Insert the nut (6) into the groove at the bottom of the spindle holders (3 and 7).
Next, slot the spindle holders (3 and 7) into the grooves in the machine.
Screw both spindle holders onto the machine with the washer (4) and the bolt (5).
Insert the spindle (with a roll of foil) (2) into the spindle holders (3 and 7).
Mount the four foil roll guides (1) onto the spindle (2).
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D 301 Evo rev.1.0
fig. 4 Installation without a spindle
fig. 5 Connection point
1
Power port
6.1.2 Installation without a spindle
Insert the guards (1) into the grooves on the machine and attach them to the machine with the
screws (2).
6.1.3 Installing the work table
Slit the work table (8) in the grooves of the machine (see fig. 3).
6.1.4 Installing the cutter
Insert the cutter (with the blade) into the cutter guide groove at the top of the machine. (see fig.
3).
Caution: do not cut yourself! The blade is extremely sharp.
6.2 Connecting the machine to the main power supply
Insert the female plug of the power cord into the power port (1) of the machine (see fig. 5).
Next, plug the power cord into the wall socket.
Connect the machine only to a power supply with earth connection and overvoltage protection
that has been secured with max. 16A.
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D 301 Evo rev.1.0
fig. 6Operating parts
No.
Name
Function
1
On/off switch
To switch the machine on and off
2
Cutter
To cut the excess foil from above the seal
To cut foil to the desired size
3
Work table
To measure the foil on the roll
4
Operating lever
To close the seal bar and start the sealing process
5
Spindle
Spindle on which to place 1 or 2 rolls of foil
6
Foil guides
Keep the roll(s) of foil in place
fig. 7 Safety applications
No.
Name
Function
1
Safety fuses
In the event of a short circuit, the machine will be switched
off by the two safety fuses (2 AT) on the print
2
Cutter
The cutter has been designed to ensure safe operation of the
blade
3
Heating
elements
Will not heat to temperatures above 190ºC
7 Operating parts
7.1 Safety applications
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D 301 Evo rev.1.0
For the best possible result and ease of operation, the bag must be filled by
Never place bags containing labels or adhesive tape between the seal bars.
8 Operation
The machine may only be used by authorised personnel. (see foreword).
Before switching on the machine, make sure that all the safety features are
present and functioning properly.
All operators are required to use personal protective equipment.
Operators must stand in front of the machine, within easy reach of the on/off
switch and the operating lever.
After an unexpected power failure, the machine will need to be restarted
manually by setting the on/off switch to ‘on’.
8.1 Switching the machine on
To switch the machine on:
•Press on the on/off switch until the machine emits a sound signal. The LED in the on/off
switch will now light up red, showing that the machine is warming up. See also section 10.1
for troubleshooting steps for the on/off switch.
8.2 Switching the machine off
To switch the machine off:
•Press on the on/off switch until the machine emits a sound signal. The LED in the on/off
switch will now extinguish, showing that the machine has been switched off.
The machine switches off automatically if it is not used for 30 minutes.
8.3 Sealing
Failure to carefully follow the seal cycle instructions below can result in
serious personal injury and/or material damage.
three quarters lengthwise and there must be at least 30 mm of free space
between the product and the inside of the seal.
16
D 301 Evo rev.1.0
fig. 8Guiding the foil
8.3.1 Sealing prefabricated bags
1. Slide the cutter to the left.
2. Place the bag on the work table and insert the foil entirely under the seal bar.
Make sure that the transparent part is facing upwards during the sealing process.
3. Lower the seal bar by pushing the operating lever forwards.
The bag will now be sealed. After 4 seconds the machine will emit a sound signal
indicating that the sealing process has been completed.
4. Raise the seal bar by pulling back the operating lever.
5. Remove the bag from the work table.
The machine is now ready to seal the next bag.
8.3.2 Making bags from a roll of foil
1. Place a roll of foil on the spindle and clamp this between two foil guides so that the roll
will stay in place.
Make sure that the transparent side will be facing up during the sealing process.
2. Slide the cutter to the left.
3. Guide the foil from the rear of the machine underneath the seal bar.
4. Pull on the foil until it has reached the desired length.
The length can be measured on the work table.
5. Lower the seal bar by pushing the operating lever forwards.
The foil will now be sealed. After 4 seconds the machine will emit a sound signal
showing that the sealing process has been completed.
6. Cut the foil by sliding the cutter to the other side of the machine.
7. Raise the seal bar by pulling back the operating lever.
8. Remove the bag from the work table.
The bag can now be filled and subsequently sealed.
9. If no bags are made, remove the film between the seal bar.
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D 301 Evo rev.1.0
Note: please also follow the safety instructions for the cleaning agents.
9 Maintenance
9.1 General maintenance instructions
Only authorised maintenance personnel are allowed to perform repair work on
the machine. (see foreword).
Always follow safety instructions carefully during maintenance operations.
All operators are required to use personal protective equipment.
If you need to perform maintenance operations that are not specified in this
manual, please contact your dealer or GIMA .
Before carrying out maintenance operations ensure that the machine has been
completely switched off. (see section 12.1).
When performing maintenance tasks or repairs, remember that the seal bars are
still hot immediately after use. Touching these can cause serious burn injuries.
Do not clean the machine with water, abrasives, chemical solvents or other
fluids.
Make sure there is a repair kit near the machine with the recommended spare
parts. (see section 11) so that defective parts can be replaced quickly and the
production process will not be interrupted longer than necessary.
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D 301 Evo rev.1.0
Component
Description
Machine
Clean the exterior of the machine with a damp cloth and soft soap
Machine
Disinfect the machine with Isopropyl alcohol
Component
Description
Cutter
Check to see if the cutter is working properly. If necessary, replace
the blade. (See section 9.3)
fig. 9 Replacing the blade
9.2 Maintenance schedule
The following maintenance schedule is based on regular use of the machine. If the machine is
used intensively or in extreme conditions, maintenance should be performed at shorter intervals.
Weekly maintenance:
Weekly maintenance may be performed by operating personnel. (see foreword). Always switch
off the machine and disconnect it from the main power supply before carrying out maintenance
operations.
Monthly maintenance:
Monthly maintenance may only be performed by authorised maintenance personnel. (see
foreword). Always switch off the machine and disconnect it from the main power supply before
carrying out maintenance operations.
9.3 Replacing the blade
Caution: do not cut yourself! The blade is extremely sharp.
A blunt blade can easily be replaced as follows:
• Remove the cutter (1) from the machine.
• Remove the blade (2) from the cutter with a pair of pliers (3).
• Insert a fresh blade into the cutter using the pliers.
• Slot the cutter back into the guides.
19
D 301 Evo rev.1.0
Problem
Cause
Solution
The machine will not
The machine is not plugged in
properly.
Insert the plug into the wall
socket properly.
The plug has not been connected
properly to the machine.
Insert the plug into the machine
properly.
Internal malfunction.
Contact your dealer or GIMA .
LED Colour
Buzzer
Meaning
Off
Off
The machine has been switched off.
Green, continuous
Off
The machine has been switched on; the seal bar
has reached the desired temperature.
Green, flashing
(slowly)
Off
The machine is busy sealing.
Green, flashing
(fast)
Continuous
The sealing process is complete. Use the
operating lever to open the seal bar.
Red, continuous
Off
The machine has been switched on, but the
temperature.
Red, flashing
On/off
The seal bar is closed and the temperature is too
reached the desired temperature.
Red, flashing
On/off
The seal bar has remained closed for too long and
operating lever to open the seal bar.
10 Troubleshooting
Below you will find a table specifying the most common malfunctions. If a problem is not listed
in this table, contact your dealer or GIMA (see the reverse of this manual for contact details).
Problems to the machine may only be resolved by authorised maintenance
start.
personnel. (see foreword).
In the event of a malfunction, always switch off the machine first. Then
consult the manual.
10.1 Codes and fault codes for the on/off switch
temperature of the seal bar is too high or too low.
Wait until the machine has reached the desired
(slowly)
low. Raise the seal bar by pulling back the
operating lever. Wait until the machine has
(slowly)
the temperature is too high or too low. Use the
10.2 Deactivating the buzzer:
The buzzer can easily be switched off as follows:
1. Switch off the machine.
2. Press the on/off switch for about 10 seconds until you hear two short bleeps.
The buzzer has now been deactivated. This will remain so until it has been reactivated.
3. To reactivate the buzzer, simply repeat the above steps.
20
D 301 Evo rev.1.0
11 Recommended spare parts
GIMA recommends always having the following spare parts on hand so that defective parts can
be replaced quickly and the production process will not be interrupted longer than necessary.
Article number Name
Number per
machine
82010 Blade (set 5 pcs) 1
82011 Self adhesive seal rubber 1
82017 Sealing bar 1
12 Taking out of operation, transportation and storage
12.1 Taking out of operation
The machine may only be put out of operation by authorised maintenance
personnel. (see foreword).
While the machine is being put out of operation all safety regulations must
be observed.
All operators are required to use personal protective equipment.
The machine must be switched off properly before it can be taken out of
operation. (see section 8.2).
No special tools or equipment are required to put the machine out of
operation.
12.1.1 Switching off the main power supply
Switch the machine off.
Disconnect the power cord from the power supply.
Disconnect the female plug of the power cord from the machine power port.
21
D 301 Evo rev.1.0
12.2 Transportation and storage
Always observe the applicable safety precautions when transporting or storing the
machine.
GIMA cannot be held liable for damage incurred during transportation and/or
storage.
Never transport or store the machine upside down.
To prevent irreparable damage to the machine, also observe specifications
applicable to the storage and transportation environment. (see Chapter 5).
12.2.1 Transport
Before transporting the machine it must be put out of operation in the correct manner. We
recommend transporting the machine in its original packaging.
The machine’s centre of gravity is at the bottom. As such, it will remain stable during transport
in normal circumstances. For safe transport of the machine, please take the weight of the
machine into consideration before starting all transport operations. (see section 13).
The relative light weight of the machine allows it to be transported manually. The machine must
be lifted from the underside.
12.2.2 Storage
Before putting the machine in storage it must be put out of operation in the correct manner. We
recommend storing the machine in its original packaging.
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D 301 Evo rev.1.0
General
Dimensions H x W x D:
307 mm(H) x 452 mm (W) x 412 mm
(D) Weight:
± 3 kg
Seal length:
300 mm
Seal width:
12 mm
Seal temperature:
180 °C
Electrical wiring
Max. capacity:
300 W
Stand-by capacity:
< 0,5 W
Voltage:
230 V
Main power supply deviation:
<10%
Frequency:
50 Hz
Fuses:
2 AT
Connector cable length:
± 1.8 m
Emission
Sound:
< 80 dB(A)
Hand/arm vibration:
< 2.5 m/s²
13 Technical details
14 To discard
In accordance with the directive 2012/19/EU, the logo below indicates that the equipment
concerned is not to be disposed of as ordinary waste at the end of its useable life. The equipment
is to be delivered to a suitable depot that will dispose of the equipment in a proper way in
accordance with the legislation on this subject, or to the supplier of new equipment in case of
replacement.
The owner of the equipment is responsible for proper disposal of the equipment.
For further information we advise you to contact your local waste facility.
Appropriate disposal of Waste of Electric and Electronic Equipment prevents unnecessary
pollution of the environment and negative influence on general health.
23
D 301 Evo rev.1.0
15 Conditions of guarantee
15.1 Liability
− We exclude any liability as far as it has not been arranged by law.
− Our liability will never exceed the amount of order.
− Subject to the general valid regulations of the law, we are not obliged to any
compensation of damage of which kind ever, directly or indirectly, under which
company damage, to movable' and immovable or to persons, both to the opposite party
as to third persons.
- In no way we are liable for damage arisen from or caused by the supplied or by the
unsuitability of this for the purpose for which the opposite party has purchased the
Sealer.
15.2 Guarantee
− With due observance of the restrictions stated hereafter, we allow 12 months of
guarantee to the products supplied by us. This guarantee is restricted to the occurring
manufacture errors and does not imply interruptions caused by any form of wear spare
parts subject to use.
− To spare parts or enclosures obtained from third persons we do not give longer
guarantee than this third supplier does.
− Guarantee expires if the opposite party and/or third parties associated make improper
use of the supplied.
− Guarantee also expires if the opposite party and/or third parties associated execute
activities and/or modifications to the supplied.
− In case we replace spare parts to fulfill our guarantee engagement, the spare parts
replaced become property of GIMA packaging machines.
- In case the opposite party does not come up completely, partially or does not come up in
time to the obligations arisen from the engagement closed between the parties, we are
not obliged to guarantee as long as the situation continues.
24
D 301 Evo rev.1.0
16 Electrical diagram
-
25
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