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OPERATING INSTRUCTIONS
MEDAP
ADAPTER COUPLING
GA 5752 5123 GB 08
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Subject to technical modification!
4
Illustrations and technical specifications may vary slightly from those in these Operating
Instructions as a result of ongoing product development.
V08 2020-07
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GA 5752 5123 GB 08
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Table of contents
Table of contents
1 Introduction ..............................................................................................................................................5
1.1 How to use these operating instructions .................................................................................................... 5
1.1.1 General ........................................................................................................................................5
1.1.2 Symbols .......................................................................................................................................5
1.1.2.1 Actions and responses .............................................................................................. 5
1.1.3 Definitions ....................................................................................................................................5
1.1.3.1 Design of safety notes ............................................................................................... 5
1.1.3.2 Structure of notes ...................................................................................................... 6
1.2 Disposal ......................................................................................................................................................6
1.2.1 Packaging ....................................................................................................................................6
1.2.2 ATMOS products .......................................................................................................................... 6
1.3 Symbols used ............................................................................................................................................. 6
1.4 Basic requirements .....................................................................................................................................7
1.4.1 Use in accordance with the intended purpose ............................................................................. 7
1.4.2 Applicable standards ....................................................................................................................7
1.4.3 Intended purpose ......................................................................................................................... 8
1.4.4 Versions .......................................................................................................................................9
2 Safety notes ............................................................................................................................................10
2.1 General .....................................................................................................................................................10
3 Initial operation, operation and use ......................................................................................................13
3.1 General .....................................................................................................................................................13
3.2 Equipment inspection ............................................................................................................................... 13
3.3 Connect plug-in coupling .......................................................................................................................... 13
3.3.1 Connect/disconnect gas probe adapter coupling ....................................................................... 13
3.3.1.1 Connector plug MEDAP, plug-in coupling DIN .........................................................14
4 Cleaning and disinfection ......................................................................................................................15
4.1 Basic instructions .....................................................................................................................................15
4.2 Cleaning ................................................................................................................................................... 16
4.2.1 General ......................................................................................................................................16
4.2.2 Cleaning procedure ....................................................................................................................16
4.3 Disinfection ............................................................................................................................................... 17
4.3.1 General ......................................................................................................................................17
4.3.2 Suitable disinfectants ................................................................................................................. 17
4.3.3 Disinfection procedure ...............................................................................................................17
5 Maintenance ............................................................................................................................................18
5.1 General .....................................................................................................................................................18
5.2 Periodic tests ............................................................................................................................................ 18
5.3 Malfunctions and troubleshooting.............................................................................................................18
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Table of contents
5.4 Repairs ..................................................................................................................................................... 18
5.5 Service hotline: ......................................................................................................................................... 18
5.6 Sending in the device ............................................................................................................................... 19
6 Technical specifications ........................................................................................................................ 20
6.1 General .....................................................................................................................................................20
6.2 Ambient conditions ................................................................................................................................... 20
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GA 5752 5123 GB 08
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1 Introduction
1.1 How to use these operating instructions
1.1.1 General
These operating instructions are provided to familiarise you with the features of this ATMOS
product. They are subdivided into several chapters.
Please note:
• Please read these operating instructions carefully and completely before using the product for
the first time.
• Always proceed in accordance with the information contained herein.
• Store these operating instructions in a location near the product.
1.1.2 Symbols
Introduction
How to use these operating instructions
1
1.1.2.1 Actions and responses
The „“ symbol identifies an action taken by the user, while the „“ symbol identifies the reaction
that this will induce in the system.
Example:
Turn on the light switch.
Lamp lights up.
1.1.3 Definitions
1.1.3.1 Design of safety notes
Pictogram Descriptor Text
DANGER!
Indicates a direct and immediate risk to
persons which may be fatal or result in
most serious injury.
WARNING!
Indicates a potential risk to persons or
property which may result in health hazard
or grave property damage.
The text for the safety note
describes the type of risk and
how to avert it.
CAUTION!
Indicates a potential risk to property which
may result in property damage.
Tab. 1: Design of safety notes
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Introduction
4
1
Disposal
1.1.3.2 Structure of notes
Pictogram Descriptor Text
Tab. 2: Structure of notes
1.2 Disposal
WARNING!
Infection hazard!
The product or some of its components may be contaminated after use.
Clean and disinfect the product before disposal.
1.2.1 Packaging
The packaging is made of materials compatible with the environment. ATMOS will dispose of the
packaging materials upon request.
NOTE Supplementary assistance or further useful information
without potential injury to persons or property damage is
described in the text of the note.
1.2.2 ATMOS products
ATMOS will take back used products or those which are no longer in service. Please contact your
ATMOS representative for more detailed information.
1.3 Symbols used
Symbols Identification
Labelling for products which were developed and are marketed in
compliance with the 93/42/EEC Medial Products Directive. Class Is, Im, IIa,
IIb and III products are also marked with the identifying number of the
Notified Body.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Name and address of the manufacturer as well as date of
manufacture’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Date of manufacture’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Follow operating instructions’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Product number’.
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Symbols Identification
Introduction
Basic requirements
1
LOT
Tab. 3: Symbols
1.4 Basic requirements
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Batch number‘.
Packaging label.
Symbol for ‘Keep dry‘.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Temperature limitations’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Relative humidity’.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for ‘Atmospheric pressure’.
1.4.1 Use in accordance with the intended purpose
Product
As per Annex IX of the Medical Products Directive 93/42/EC this product belongs to class IIa. In
accordance with this directive, the product may only be used by persons who have been
instructed how to use this product by an authorised person. This product is to be used exclusively
for human medicine. When employed in a commercial or business use, this product must be
entered in the inventory.
Accessories
Accessories or combinations of accessories may be utilised only as and when indicated in these
operating instructions. Other accessories, combinations of accessories and consumable items
may be used only if they have a valid certification, are intended expressly for the particular use
and will not adversely affect performance, the prescribed ambient conditions or safety
requirements.
1.4.2 Applicable standards
The product satisfies the basic requirements set forth in Annex I to the 93/42/EC Directive drafted
by the Medical Products Council (Medical Products Directive) as well as the applicable national
(German) codes and the Medical Products Act in Germany. This has also been demonstrated
through the application of the corresponding standards, which have been harmonised with the
93/42/EEC Directive.
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Introduction
1
Basic requirements
1.4.3 Intended purpose
Name: Adapter couplings
Main function: Adapter between DIN and MEDAP standards
Medical indications /
application:
Specification of the main
function:
User profile: Doctor, medically trained staff
Patient groups: Patients of all ages
Application organ: No specific organ
Application time: For continuous operation; in practice, short-term use on the patient
Application site: The application site is the clinical environment and doctor’s
Contraindications: The adapter couplings may not be used:
For connection of a gas probe MEDAP with a terminal unit DIN
Adapter couplings consist of a gas probe MEDAP and a coupling
DIN. For connection of a gas probe DIN with a terminal unit of a
central gas supply in MEDAP standard, an adapter coupling with
gas probe MEDAP and coupling DIN is needed. The gas probe
MEDAP of the adapter coupling is inserted to the terminal unit
MEDAP of the central gas supply. The gas probe DIN is inserted
into the coupling DIN of the adapter coupling. The permitted
nominal supply pressure is 400 kPa to 500 kPa +/-10%.
(<30 days)
practices which do have a central gas supply system. The
application of the product may only be performed by medically
trained and instructed staff.
• Outside the medical sector
• In MR areas
• For ultra-pure gases
• For liquids
• For corrosive, aggressive and toxic gases, acetylene, propane,
butane and other flammable gases
• At a nominal supply pressure of the central gas supply system
other than 400 kPa to 500 kPa +/–10%.
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GA 5752 5123 GB 08
The product is: Not active
Sterility: Not a sterile product
Single-use product /
reprocessing:
The product and parts of the accessories are reusable. For
information on reprocessing, cleaning and disinfection please see
the operating instructions.
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1.4.4 Versions
Products and accessories are only permitted with the ISO colour coding.
• MEDAP gas probe DIN plug-in coupling; compressed air; ISO colour coding; REF 5752 5093
• MEDAP gas probe, DIN plug-in coupling; oxygen; ISO colour coding; REF 5752 5095
Introduction
Basic requirements
NOTE
The gas probe is rotatable for adapter couplings with DIN gas probes.
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Safety notes
2
General
2 Safety notes
2.1 General
DANGER!
Fire/explosion hazard!
Air, oxygen and oxygen compounds react explosively with oils, greases and
lubricants. Fire and explosion hazard due to compressed gases.
Keep product, in particular for oxygen, free of oils, greases, lubricants and hand
cream. Only use lubricants which are approved by ATMOS. Observe fire protection
regulations when dealing with flammable gases. Contact Technical Service about
any leakages in the product.
DANGER!
Fire hazard!
Fire hazard as a result of escaping oxygen.
Never smoke near equipment which carries oxygen and avoid using open fires or
glowing objects. Check the connector for leaks and tight fitt when mounting
accessories.
DANGER!
Fire hazard!
The product may ignite if the maximum operating pressure or the maximum
operating temperature is exceeded.
Do not exceed the maximum operating pressure or maximum operating
temperature.
DANGER!
Defective product!
Using incorrect spare parts and accessories can cause injuries or equipment
failure.
Only use original accessories or spare parts.
WARNING!
Risk of injury!
Worn or damaged products can cause injuries.
Use only products which are in perfect condition.
WARNING!
Malfunction!
To avoid malfunctions or damage, do not apply any mechanical forces to the
product from the plug-in connection.
10
WARNING!
Malfunction!
Do not expose the product to torsion, as this might impair its proper function.
Mount accessories in such a way that they remain torsion-free and tension-free.
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Safety notes
General
WARNING!
Impact!
Sensitive precision components may be damaged if the product is exposed to
impact.
WARNING!
Permissible load!
Leakages may occur at the point of connection of ‘terminal unit and gas probe‘.
In accordance with DIN EN ISO 9170-1, the overall weight of the units directly
connected to the terminal unit may not exceed 2 kg.
WARNING!
Ambient conditions!
The precision, operation, mechanical stability and tightness of the product cannot
be guaranteed if the maximum upper and lower ambient temperatures are
exceeded during operation.
2
CAUTION!
Property damage!
The plug-in coupling may be damaged if the wrong gas probe is connected.
Compare coding of the gas probe with plug-in coupling. Only use gas probes
corresponding to DIN EN 13260-2 or the MEDAP works standard. Never use
contaminated gas probes.
CAUTION!
Property damage!
During preparation no liquid must enter the product, as it may become inoperative.
CAUTION!
Property damage!
Do not insert pointed or sharp objects, as this may damage the product.
Do not insert pointed or sharp objects into the product.
DANGER!
Danger to life!
Danger due to improper configuration of the system!
The configuration of the overall system as well as the functional testing are subject
to the overall responsibility of the medical staff.
The operator must check the proper functionality and suitability of the connected
accessories for each intended application prior to every use, in particular,
connection parts, sealing properties and suitability with regard to material, work
pressure and flow.
DANGER!
Danger to life!
When using oxygen, a kink in the connection tube may cause the oxygen supply to
be interrupted.
Ensure that there are no kinks in the connection tube.
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2
Safety notes
General
CAUTION!
Property damage!
Condensate in the interior of the valve may lead to a loss in functionality.
100% air humidity must be avoided.
CAUTION!
Reduced performance!
Length and inner diameter of the product used may impair the maximum available
gas volume.
Check the gas volume available at the tapping unit.
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3 Initial operation, operation and use
4
2
3
1
3.1 General
• Gas probe MEDAP (1)
1
2
4
• Gas type (2)
• Connection tube (3)
• Plug-in coupling DIN (4) without park posi-
Initial operation, operation and use
General
tion
3
3
Fig. 1: Connector plug MEDAP, plug-in coupling
DIN
3.2 Equipment inspection
NOTE
Before using the product for the first time perform a disinfection.
NOTE
Please refer to the manufacturer’s instructions for the particular terminal unit for
information on connecting the gas probe to the terminal unit.
Examine the plug-in coupling for correct functioning and contamination or damages.
Check the connection tube for leaks.
3.3 Connect plug-in coupling
3.3.1 Connect/disconnect gas probe adapter coupling
CAUTION!
Property damage!
The plug-in coupling does not have a park position. When plugging in the
connection device, the preset pressure is on immediately.
Only connect accessories via gas probe with tube.
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Initial operation, operation and use
3
1
2
4
4
1
2
3
3
Connect plug-in coupling
3.3.1.1 Connector plug MEDAP, plug-in coupling DIN
4
2
3
1
Couple gas probe
Press in gas probe (1) until it stops in the
terminal unit (2) or press until the sliding
sleeve snaps.
The arrow (3) on the label of the gas
probe corresponds to the axis of the
arrow (4) on the cover plate of the
terminal unit.
Operating position for gas supply is
achieved.
Fig. 2: Couple adapter coupling
4
2
3
Fig. 3: Decouple adapter coupling
Release gas probe
Press thumbs on the plate (1) of the gas
probe.
Use two fingers to pull the slide sleeve (2)
1
of the gas probe (3) to the back.
Pull out gas probe from terminal unit (4).
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4 Cleaning and disinfection
4.1 Basic instructions
The product must be cleaned as well as wipe disinfected after every use.
DANGER!
Risk due to incorrect use of detergents and disinfectants!
It is strictly advised to observe the manufacturer instructions regarding how to use
the detergents and disinfectants as well as to observe the valid hospital hygiene
rules.
DANGER!
Infection hazard!
Product may be contaminated.
Always wear gloves for cleaning / disinfection.
DANGER!
Infection hazard!
Particles of grime may become encapsulated and lead to the product not reaching
the desired germ reduction after disinfection.
Before disinfection, the product must be cleaned thoroughly of contamination and
encapsulated particles of grime.
Cleaning and disinfection
Basic instructions
4
DANGER!
Health hazard!
The product is also used to administer respiratory gas. Residues of sterilisation
gases or other substances in the unit could endanger the patient's health.
Do not disassemble the product and do not clean it by gas sterilisation or any other
mechanical cleaning or sterilisation method. Ensure that no disinfectant or cleaning
agent enters the product.
CAUTION!
Improper cleaning and disinfection can cause property damage!
Do not use the following products for cleaning and disinfection:
• Products containing alcohol (e.g. hand disinfectants)
• Halogenides (e.g. fluorids, chlorides, bromides, iodides)
• Dehalogenating compounds (e.g. fluorine, chlorine, bromine, iodine)
• Products that may scratch the surface (e.g. scouring agents, wire brushes, wire
wool)
• Standard commercial solvents (e.g. benzene, thinner)
• Water containing iron particles
• Cleaning sponges containing iron
• Products containing hydrochloric acid
Use a soft, lint-free cloth or a soft nylon brush to clean the product.
CAUTION!
Improper cleaning and disinfection can cause property damage!
Use only as much detergent and disinfectant as required.
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Cleaning and disinfection
4
Cleaning
4.2 Cleaning
CAUTION!
Improper cleaning and disinfection can cause property damage!
Perform visual and functional inspections after each cleaning and disinfection
process.
CAUTION!
Property damage!
The product is not suitable for live steam sterilisation or spray disinfection! Do not
clean the product by live steam sterilisation or spray disinfection.
CAUTION!
Property damage!
Using non-colour-fast surgical drapes can cause discolouration of surfaces.
Only use colour-fast drapes.
4.2.1 General
CAUTION!
Improper cleaning can cause property damage!
Residues of physiological saline solutions (e.g. sodium chloride) can attack the
surfaces of the product.
Remove residues of physiological saline solutions with a cloth dipped in clean
water. Then dry the product with a dry, lint free cloth.
CAUTION!
Improper cleaning can cause property damage!
Do not spray cleaning agent directly into the joints or gaps and never use a highpressure cleaning unit!
NOTE
Use only all-purpose cleaners which are slightly alkaline (soap solution) and
contain surfactants and phosphates as the active cleaning agents. In the event that
surfaces are heavily contaminated, use concentrated all-purpose detergent.
4.2.2 Cleaning procedure
Use the correct dose of multi-purpose detergent with water for the degree of surface
contamination and in accordance with the instructions of the detergent manufacturer.
Thoroughly wipe off the product with a soft cloth slightly wetted in a multi-purpose detergent
solution.
Ensure that the product is free of contamination and encapsulated particles of grime.
Thoroughly wipe off the product with a soft cloth dipped in clean water.
Ensure that the product is free of detergent residues.
Dry the product with a dry, absorbent and lint free cloth.
This will help to reduce pathogen growth on the product's surface.
Wipe disinfect the product after every cleaning process.
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4.3 Disinfection
4.3.1 General
NOTE
In the event of product surfaces that are very dirty, carry out an additional cleaning
procedure before disinfecting the product.
CAUTION!
Material damage due to excessive exposure times!
Exceeding the specified exposure time of the disinfectant may damage the
surfaces.
Observe the specified exposure time of the disinfectant manufacturer.
4.3.2 Suitable disinfectants
Only surface disinfectants based on the following combinations of active ingredients may be used
for disinfection:
• Aldehydes
• Quaternary compounds
• Guanidine derivatives
Cleaning and disinfection
Disinfection
4
Ingredient group Active ingredients
Aldehydes 2-ethyl-1-hexanal, formaldehyde, glutardialdehyde, glyoxal,
Quarternary compounds Alkyl-didecyl-polyoxethyl ammonium propionate, alkyl-dimethyl-
Guanidine derivatives Alkyl-biguanide, chlorhexidine-digluconate, cocospropylene-
Tab. 4: Active ingredients of disinfectants
4.3.3 Disinfection procedure
Wipe disinfect the product in accordance with the instructions of the disinfectant manufacturer
after every cleaning process.
Ensure that the product is free of disinfectant residue.
Perform visual and functional inspections.
o-phthaldialdehyde, succinaldehyde
alkylbenzyl ammonium chloride, alkyl-dimethyl-ethyl ammonium
chloride, alkyl-dimethyl-ethylbenzyl ammonium chloride,
benzalkonium propionate, benzalkonium chloride (alkyl-dimethylbenzyl ammonium chloride, coco-dimethyl-benzyl ammonium
chloride, lauryl-dimethylbenzyl ammonium chloride, myristyldimethyl-benzyl ammonium chloride), benzethonium chloride,
benzyl-dihydroxyethyl-coco-alkyl ammonium chloride, dialkyldimethyl ammonium chloride (didecyldimethyl ammonium chloride),
didecyl-methyl-oxyethyl ammonium propionate, mecetronium-ethyl
sulfate, methyl-benzethonium chloride, n-octyl-dimethyl-benzyl
ammonium chloride
diamine guanidinium diacetate, oliogomeric biguanide,
polyhexamethylene biguanide hydrochloride (oligo-diimino imiodocarbonyl imino-hexamethylene, polyhexanide)
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Maintenance
5
General
5 Maintenance
5.1 General
Maintenance, repairs and periodic tests may only be carried out by persons who have the
appropriate technical knowledge and are familiar with the product. To carry out these measures
the person must have the necessary test devices and original spare parts.
ATMOS recommends: Work should be carried out by an authorised ATMOS service partner. This
ensures that repairs and testing are carried out professionally, original spare parts are used and
warranty claims remain unaffected.
5.2 Periodic tests
At least every 5 years a test must be performed.
5.3 Malfunctions and troubleshooting
Defect Source of malfunction Corrective actions
Gas escapes with connected
gas probe
Gas probe cannot be
inserted
Gas probe is difficult to insert Gas probe is defective as a
Tab. 5: Corrective actions
5.4 Repairs
The following may require repairs from by the manufacturer or an authorised service partner:
• Liquid has penetrated the device.
• The performance has significantly decreased.
• Inexplicable notifications appear.
• Abnormal noises occur.
• Functional faults cannot be rectified according to the measures in chapter Malfunctions and
troubleshooting [ page 18].
If defects are detected, the product may not be used any longer.
Make a note of the deficiencies and the REF number on the type plate and inform your ATMOS
representative.
Observe the information in chapter Sending in the device [ page 19].
Plug-in coupling defective Inform Technical Service.
Gas probe is designed for
different gas types than the
adapter coupling
The coding of the gas probe
differs to that of the adapter
coupling
Gas probe is deformed Inspect gas probe and have it
result of tension or torsion
forces in terms of function
Only use gas probes designed for
same gas type as the adapter
coupling.
Use MEDAP gas probe for
MEDAP adapter coupling and
use DIN gas probe for DIN
adapter coupling.
replaced, if required
Remove mechanical load and
have plug-in coupling checked if
necessary.
5.5 Service hotline:
+49 7653 689-0
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5.6 Sending in the device
Remove and properly dispose of consumables.
Clean and disinfect the product and accessories according to the operating instructions.
Place used accessories with the product.
Fill in the form QD 434 „Delivery complaint / return shipment“ and the respective
decontamination certificate.
This form is enclosed with each delivery and can be found at www.atmosmed.com.
The device must be well padded and packed in suitable packaging.
Place the form QD 434 „Delivery complaint / return shipment“ and the respective
decontamination certificate in an envelope.
Affix the envelope to the outside of the package.
Send the product to ATMOS or to your dealer.
Maintenance
Sending in the device
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Technical specifications
6
General
6 Technical specifications
6.1 General
Classification as per Medical Products Directive 93/42/EEC Class IIa
Nominal supply pressure for compressed gases 400 - 500 kPa ± 10%
6.2 Ambient conditions
Temperature: Shipping / storage –15 °C to +50 °C
Temperature: Operation –10 °C to +40 °C
Relative humidity: Shipping / storage 10% to 90%
Relative humidity: Operation 30% to 75%
Atmospheric pressure: Shipping / storage 700 hPa to 1060 hPa
Atmospheric pressure: Operation 700 hPa to 1060 hPa
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Notes
Page 22
Notes
Page 23
Notes
Page 24
Manufacturer:
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
79853 Lenzkirch
GERMANY
Phone: +49 7653 689-0
www.atmosmed.com
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