PAXXO PACTOSAFE 4.0 User manual

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
S.4044:22
English (original instructions) ......................................................................................................6
Türkçe....................................................................................................................................20
Ελληνικά ...............................................................................................................................34
Slovenščina ............................................................................................................................48

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
DECLARATION OF CONFORMITY
Manufacturer:
PAXXO AB Tel: [phone]
Bjurögatan 35 E-mail: [email protected]
211 24 MALMÖ Web: www.paxxo.com
Sweden www.pactosafe.com
We, PAXXO AB, declare under our sole responsibility that the product(s) to which this declaration
relates is/are in conformity with the technical requirements of the standard(s) and directive(s) declared
on this declaration of conformity.
Brand: Pactosafe
Models no: 540WS and 540WSWM
to which this declaration relates are manufactured in conformity with DIRECTIVE 2006/42/EC of the
European Parliament and of the Council on the approximation of the laws of the Member States
relating to machinery with special reference to Annex 1 on essential health and safety requirements in
relation to construction and manufacturing of machines, and are in conformity with the following
standard(s) or other normative document(s):
following the provisions of the Directives:
• Low Voltage Directive (2014/35/EU)
• Electromagnetic Compatibility Directive (2014/30/EU)
• Machinery Directive (2006/42/EC)
• WEEE Directive – Waste Electrical and Electronic Equipment (2012/19/EU)
• RoHS Directive – restriction of the use of certain hazardous substances in
electrical and electronic equipment (2011/65/EU)
following the provisions of harmonised Standards:
• SS-EN ISO 12100:2010 “Safety of machinery – Basic concepts, general principles for
design. Basic terminology, methodology (ISO 12100–1:2003)”
• SS-EN 60204–1:2018 “Safety of machinery – Electrical equipment of machines”
• IEC 61010–1:2010 “Safety requirements for electrical equipment for measurement,
control and laboratory use – Part 1: General requirements”
• IEC 61326-2-3:2013 Electrical equipment for measurement, control and laboratory use –
EMC requirements. Emission Class A and B. Immunity: Basic and Industrial.
The machine is approved by TÜV NORD in accordance with DIN EN 61010–1:2011 and EN 61010-
1:2010. TÜV NORD GS-Mark Certificate no. 44 786 130714-001, dated 29.04.2019.
The machine is approved by MET LABORATORIES, INC in accordance with UL 61010–1/CSA
C22.2 No 61010-1. MET Certificate no. E113370, dated 27.04.2012.
CB test certificate IEC 61010–1 by NEMKO, test report 187875.
Henrik Peters
Managing Director, Paxxo AB
Malmö 2021-02-01

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
Table of Contents – English
1. Introduction .......................................................................................................... 6
2. Storage and transport........................................................................................... 7
3. Safety instructions ................................................................................................ 7
4. Functional description........................................................................................... 9
5. Technical specification........................................................................................ 10
6. Unpacking/Putting into operation........................................................................ 11
7. Replacement of foil cassette ............................................................................... 12
8. Waste disposal ................................................................................................... 13
9. Adjustment of bag length.................................................................................... 13
10. Battery operation and charging (optional).......................................................... 13
11. Checking the sealing result ............................................................................... 14
12. Checking the safety device ............................................................................... 14
13. Troubleshooting................................................................................................ 14
14. Cleaning and decontamination.......................................................................... 16
15. Replacing the plug-in unit ................................................................................. 17
16. Disposal ........................................................................................................... 17

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
1. Introduction
This manual contains information about the Pactosafe® (hereinafter “the machine”).
Manufacturer:
PAXXO AB
Bjurögatan 35
SE-211 24 MALMÖ
Sweden
Tel: [phone]
E-mail: [email protected]
www.paxxo.com
Important!
All personnel working with this product are obligated to read and make sure they understand
this manual. Special attention should be paid to the section regarding safety.
No changes may be made to the product without the written consent of the manufacturer.
Always state the serial number when contacting the distributor/manufacture. It is found on the
back of the machine.
The company is certified in accordance with ISO 9001 and 14 001.
Application:
The Pactosafe waste sealing unit is designed to be used for the safe packaging of hazardous
waste. No sharp objects or syringes.
Placing:
The Pactosafe waste sealing unit is always supplied together with a stand on wheels which is
designed to stably stand on the floor.
PAXXO AB
Henrik Péters
Managing Director

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
2. Storage and transport
Storage and transportation guidelines:
The machines may only be stacked 2 (two) on top of each other.
Humidity range 10–90%.
Temperature 0–40ºC (32–100ºF).
Maximum 2000 m (6000 ft) above sea level.
3. Safety instructions
For safe use of the machine, the following instructions must be followed:
Before using the machine, the operator must have undergone training and have read and
understood the manual and its instructions. The training is important to avoid danger and injury. If
the equipment is used in a manner not specified by the manufacturer, as indicated in this manual,
protection provided by the equipment and accessories may be impaired.
The Pactosafe 540WS (stationary version) must be connected to a grounded electrical outlet and
a maximum length of power cord of 10 feet/3 metres.
The power cord may only be connected to an easy-to-reach electrical outlet. Make sure that
nothing is blocking the outlet from the machine.
When plugging and unplugging the unit from the electrical outlet, it is important to only pull on the
plug and not the cable.
Explanation of symbols:
Symbol A Symbol B Symbol C Symbol D Symbol E
Symbol A:
Attention! Read the operator’s manual explanation of signs.
Symbol B:
Keep fingers and hands clear of the funnel when the sealing bars are closing. Entanglement
hazard. Do NOT operate with exposed long hair, jewellery or loose clothing as this may cause
injuries.
Symbol C:
Caution, hot surface can occur during, or after, sealing of material.
Symbol D:
Warning, biohazard.
Symbol E:
It is prohibited to put metal parts or medical instruments in the machine.
The machines must not be used with any sharps or syringes.

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
Continued from previous page.
The machine is classified as laboratory equipment and should be managed as such. The machine
can be used in all patient areas of the hospital, but only if the machine is placed at least 1.5 m
away from the patients and the machine is not left unattended.
The operator must show due regard to the environment when handling residual products by
avoiding the release of hazardous substances and/or must adhere to local, national or international
regulations.
To ensure complete sealing, the waste must have passed the sealing bars before they close.
The machine is to be used according to working environmental policies and requirements of
European, national or international regulations and directives.
The control systems or electrical installation not covered by our delivery must be installed by
authorised personnel and the installation must conform to the relevant EU directive, standards
and/or local regulations.
The operator is not allowed to perform any modifications, repairs or maintenance on the machine!
Modifications, repairs, servicing and maintenance have to be performed by authorised personnel
from PAXXO only. The operator may only undertake routine cleaning of the machine as described
in this manual.
The machine may not be used until any fault or shortcoming has been rectified.
If the machine cannot be used, replacement plug-in units are available.
Do not work with the machine if the power cord or the housing of the power supply or battery
charger has been damaged.
This may cause electric shock!
Any damaged power cord or housing of the power supply or battery charger must be replaced by
a component of the same exact type before using the machine again.
The operator is not under any circumstances allowed to replace the batteries by himself/herself.
The rechargeable battery pack has to be replaced only by authorised personnel from PAXXO.
Safety devices and warning stickers must be checked regularly. If applied stickers have been
damaged or are unreadable, they must be replaced immediately.
Only cassettes designed for the machine may be used. The warranty is only valid when Pactosafe
cassettes are used. Other types of foil might ignite and start a fire.
This machine has a noise level below 70 dB.
For any cleaning operations, the machine must be switched off and unplugged. More instructions
regarding cleaning can be found in chapter 14.
It is prohibited to put any kind of flammable liquids into the waste.

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
4. Functional description
The machine is designed for the handling of hazardous waste.
The waste is placed in a funnel (a), which is covered by a seemingly endless, tubular
polyethylene (PE) foil (b).
When the foot pedal is pressed, the open end of the PE foil (c), with the waste inside, is
sealed together.
The sealed bag is then fed down (d) into the hazardous waste container below the unit (e),
while at the same time a new foil from the bag cassette is fed in so that further waste can be
packaged.
Should a longer bag than the pre-set length be required, press the foot pedal until the waste
has passed the sealing bars.
The machine does not release any hazardous substances, gases or other emissions during
sealing. Complete incineration of the foil will only yield water, carbon dioxide (CO2) and energy.

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
5. Technical specification
Device Pactosafe 4.0 Wide
Type 540WS, 540WM
IP Class IP20
Protection class III, SELV (safety extra-low voltage)
Rated Voltage 12 V DC
Rated current 9 A ±10%
Warranty on unit 2 years
Electrical specification for switching power adapter:
Main voltage input 100-240 V AC
Main frequency 50/60 Hz
Main voltage output 12 V DC
Rated current 0.7 A input Max 10 A output
Protection class I
Power consumption 130 W
Power consumption in standby 1W
Connection input EU, UK or JP plug
Approvals TUV GS, MET US/C
Manufacturer Power-Win Technology Corp.
Model PW-100A-1Y12GPB
Electrical specification for battery charger:
Main voltage input 100-240 V AC
Main frequency 50/60 Hz
Rated current input 0.6 A
Protection class II
Output 5,0-15V DC 1A, 2,1 mm pin
Connection input EU, UK or JP plug
Approvals TUV GS, MET US/C
Manufacturer Mascot
Model Pactosafe, Type 2216
The machine may only be used with Pactosafe charger Type 2216 made by Mascot
Battery specification:
Battery pack 12V Ni-MH, 8000mAh
Model 10 cells D size
Battery charging Max. 1.8 A 12 V DC
Manufacturer Shenzhen SupPower
Warranty on battery 1 year
Manufacturer’s declaration:
Manufacturer Paxxo AB verifies that 100% of incoming power adaptors and battery chargers are tested
by suppliers according to the requirements for the product.

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
6. Unpacking/Putting into operation
The machine is delivered mounted, in a box. The stand has to be set to the desired height; the
foot pedal and cable have to be connected. The packing must then be recycled.
•Remove all components from their packaging.
•Check that all components are present; see pictures 1–6.
The power adaptor (3) is only included in the stationary model and the battery charger
(4) is only included in the mobile model.
•Set the stand (1) to the desired height using the four screws and nuts (2). Connect the
power adaptor (3) or battery charger (4) to an electrical outlet with the same
specification as indicated on the label of the power adaptor or battery charger.
N.B.: The picture is only an example. The sign may vary depending on the country
where the machine is used.
•Fit the foot pedal (6) to the front panel, cut the air hose to the desired length.
•Turn on the switch.
N.B.: The machine takes approx. 5 seconds to start up.
•Press the foot pedal and check that the foil is feeding down on both sides and it is
being sealed.
•Check the sealing result against the pictures in Section 11.
•The machine is now ready to use.
1

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
7. Replacement of foil cassette
To signal the end of the foil cassette and that it is time to replace it, a red STOP is printed on the
last 2 metres of the foil.
Only the original foil cassette from PAXXO, item number
10880 , is to be used.
Any other types of foil might ignite and start a fire. It is
important to use the right type of foil cassette as
functionality cannot otherwise be guaranteed.
•Turn off the switch.
•Open the cover and place the foil cassette around the funnel and cut the ribbons (1).
Pull the foil from the outside (2).
•Pull the foil down and make sure that the feeding wheels grip the foil (3).
•Turn on the switch and wait approx. 5 seconds.
•Press the foot pedal and check that the foil is fed down on both sides and is being
sealed.
•Close the cover.
•Check the sealing result against the pictures in Section 11.
•The machine is now ready to use.
2
1
3

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
8. Waste disposal
The packaged waste should be collected in a container for hazardous waste and handled
according to local instructions. The system is tested for safe disposal of cytotoxic waste for 7
(seven) days.
For more information go to: www.pactosafe.com
9. Adjustment of bag length
If required, the bag length can be adjusted.
The adjustment range is from approx. 140–400 mm.
The length of the bag is pre-set using a knob to the right on the front panel of the unit.
The pre-set value is the length of the next bag after sealing.
The bag length can be increased by keeping the foot pedal depressed before sealing.
Tip! Avoid unnecessarily long bags to conserve foil usage. Minimise the volume. Avoid long bags,
as air fills up the bags and the waste container fills up sooner.
10. Battery operation and charging (optional)
A battery is available as an optional extra when ordering.
Red LED light on front panel is constantly
lit. Do not use the machine – it needs to be charged.
Red LED light lights up during sealing. This does not mean that something is wrong; wait.
Orange LED light on the charger. The battery is being rapidly charged.
Yellow LED light is lit. The battery is not connected or the charger is starting up.
Orange/green LED light flashes. Something is wrong with the charging or connection.
Green/yellow LED light on charger. The charger has reached its peak.
Green LED light on the charger. The battery is fully charged – disconnect the charger.
•If the machine is not to be used for a long time, switch it off to save the battery. Keep in mind
that the machine takes about 5 seconds to start after the switch has been switched on again.
•For the battery not to lose its ability to charge, it must be charged at least once a month.
•Never use the machine while it is charging.
•After about 6 hours of charging, the charger switches to maintenance charging/pulsing.
•Always unplug the charger from the wall outlet before disconnecting it from the machine.
•When charging, always connect the charger to the machine before connecting it to the wall
outlet.
•The battery has a longer life if it is fully charged before use and should always be fully charged.
•The machine may only be charged with the Pactosafe charger Type 2216 manufactured by
Mascot.

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
11. Checking the sealing result
It is important to check the result of the sealing regularly to ensure that the bags are hermetically
sealed. Severe wear and tear on the sealing bars or damage to them can adversely affect the
result.
The foil has not melted together.
Correct sealing joint.
Flat and even sealing joint.
Holes in the foil, uneven sealing
joint.
12. Checking the safety device
It is important to check the crush guard on a weekly basis.
Press on the foot pedal and hold an object of 10–20 mm thickness between the sealing bars. The
sealing bars should stop and return to their starting position when they encounter resistance more than
8 mm in thickness.
Check annually whether the stickers on the funnel are damaged. Contact the manufacturer if they need
to be replaced.
13. Troubleshooting
Always state the serial number when contacting the distributor/manufacturer.
It is found on the back of the machine.
When ordering, a newly repaired plug-in unit is sent with
replacement instructions, and the defective plug-in unit should
be returned in the same box. The plug-in units are repaired and
delivered in tailor-made boxes.
Spare part list:
543WS
Plug-in unit
5424
Power adaptor
5428
Battery pack
543WM
Plug-in unit with battery
5910
Power cable
5524
Knobs
5410
Funnel, wide
5426
Batttery charger
5602
Foot pedal
5557
Wingnuts for legs (4 pcs)

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
Continued from previous page, 13. Troubleshooting
Issue
Possible cause
Action
Nothing happens when
pressing the foot pedal.
The machine is not connected to an
electrical outlet.
Connect the machine to an electrical
outlet.
Switch is not on. Turn on the switch.
No signal from foot pedal.
Check its connection and whether it
is damaged. Shorten or replace if
necessary.
The machine is starting up. The system takes 5
seconds to
become operational.
Battery discharged. Charge the battery.
The feeding of the foil
works but not the sealing.
Something is jamming the cog wheels and
is blocking the sealing bars.
Check the sealing bars to make sure
nothing is stuck. Turn the unit upside
down to check that nothing is stuck
under the unit. Shake g
ently if
necessary. See section
15
“Replacing the plug-in unit”
.
The sealing bars are damaged. Contact the distributor/manufacturer.
Something is wrong inside the unit.
Incomplete sealing of the
foil.
See picture in Section 11.
The sealing bars are damaged.
Contact the distributor/manufacturer.
Something is wrong inside the unit.
The sealing of the foil is
too powerful.
See picture in Section 11.
Something is wrong inside the unit.
Contact the distributor/manufacturer.
With frequent use, the sealing bars can
build up heat and the plastic melts in the
seal joint. To avoid this, wait at least
15 seconds between each seal, so that the
sealing jaws have time to cool. It can also
be an indication that the funnel is
incorrectly fitted or that the plastic is pulled
down unevenly. Apply the ca
ssette again
and make sure that the funnel is seated
correctly.
The foil is adhering to the
sealing bars.
Waste is stuck between the sealing bars.
Clean the sealing bars with alcohol.
The sealing bars are damaged.
The sealing bars will not
return t
o the start
position.
Switch the unit OFF and then ON
again. The machine will return to its
start mode.

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
14. Cleaning and decontamination
The machine must be decontaminated by cleaning according to the instructions below.
Always use suitable gloves.
It is important to decontaminate the machine to avoid transmission of drugs and infection.
•Turn off the switch.
•Unplug the power cord from the electrical outlet.
•Use a clean cloth to wipe the chassis and the stand with
alkaline detergent (pH> 7) and then use water to wash
away any drug residues.
•For platinum-containing chemotherapy drugs, a cleaning
agent with acidic properties (pH <3) and water must
then be used.
After this, an alcohol-based disinfectant can be used to
eliminate microorganisms.
Alternatively, disinfectants containing surfactants can be
used, eliminating both drug residues and
microorganisms.
•If the nature of the contamination is such that Chlorine or
Virkon is better suited, this can certainly be used.
•Dry the sealing jaws (1) and the feeder wheels (2) with
an alcohol-based cleaner, once a week, for extended
functionality.
•Plug in the power cord to the electrical outlet.
•Turn on the switch.
•The machine is now ready to use.
1
2

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
15. Replacing the plug-in unit
Removing the plug-in unit
•Turn off the switch on the front panel.
•Pull out the air hose that leads to the foot pedal from the front panel
(see picture).
•Disconnect the cable at the back.
•Unscrew the two knobs on the upper edge of the back.
•Carefully remove the plug-in unit from the frame, like a drawer.
1. Clean the plug-in unit according to the instructions above
before returning it.
2. Turn the unit (upside down) and clean the rectangular area
where all waste passes.
Fitting a new plug-in unit
•Fit the supplied replacement plug-in unit into position.
•Screw the two black knobs at the back securely into place.
•Connect the cable at the back.
•Push the hose for the foot pedal into place on the front panel.
•Switch the unit on.
Returning a unit
Put the used and replaced plug-in unit in the box.
Instructions for replacing and cleaning the unit are included
in the box.
Fill in the attached status report and specify the error.
Return the box immediately to the distributor/Paxxo.
16. Disposal
The power adaptor/battery charger and plug-in unit for the Pactosafe can be sent back to the
manufacturer for recycling. Recycle the stand and chassis as metal. When replacing the battery,
the battery should be taken to a battery disposal/recycling station.
Knobs

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
İçindekiler – Türkçe
1. Giriş.................................................................................................................... 20
2. Saklama ve taşıma.............................................................................................. 21
3. Güvenlik talimatları.............................................................................................. 21
4. İşlevsel açıklama ................................................................................................. 23
5. Teknik özellikler................................................................................................... 24
6. Ambalajdan çıkarma/Çalıştırmaya başlama .......................................................... 25
7. Folyo rulosunun değiştirilmesi .............................................................................. 26
8. Atık bertarafı ....................................................................................................... 27
9. Torba uzunluğunun ayarlanması .......................................................................... 27
10. Pille çalıştırma ve şarj (isteğe bağlı) ..................................................................... 27
11. Kapatma işlemi sonucunun kontrol edilmesi ...................................................... 28
12. Güvenlik mekanizmasının kontrol edilmesi ......................................................... 28
13. Sorun giderme.................................................................................................. 28
14. Temizleme ve arındırma .................................................................................... 30
15. Fişli ünitenin değiştirilmesi .................................................................................. 31
16. Bertaraf ............................................................................................................ 31

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Paxxo AB, Bjurögatan 35, 211 24 Malmö, Sweden • Tel: [phone] • www.paxxo.com
1. Giriş
Bu kılavuz Pactosafe® (Bundan sonra “makine” olarak anılacaktır) ile ilgili bilgileri içerir.
Üretici:
PAXXO AB
Bjurögatan 35
SE-211 24 MALMÖ
İsveç
Tel: [phone]
E-posta: [email protected]
www.paxxo.com
Önemli!
Bu ürünle birlikte çalışan tüm personel bu kılavuzu okumalıve anladığından emin olmalıdır.
Güvenlikle ilgili bölüm özellikle dikkatle okunmalıdır.
Üreticinin izni olmadan ürün üzerinde herhangi bir değişiklik yapılamaz.
Dağıtıcıyla/üreticiyle iletişim geçtiğinizde daima seri numarasını belirtin. Seri numarası makinenin
arkasında yer alır.
Şirket ISO 9001 ve 14 001’e uygun olarak onaylanmıştır.
Uygulama:
Pactosafe atık izolasyon ünitesi, tehlikeli atıkların güvenli şekilde paketlenmesinde kullanılmak üzere
tasarlanmıştır. Keskin nesnelere veya şırıngalara uygun değildir.
Yerleştirme:
Pactosafe atık izolasyon ünitesi her zaman zeminde sabit şekilde durması için tasarlanmışsabit
duruştekerlekleriyle birlikte tedarik edilir.
PAXXO AB
Henrik Péters
İdari Yönetici