Page 1
OPERATING INSTRUCTIONS
MEDAP
CONNECTION TUBES
GA 5752.5124 GB 10
Page 2
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.
V10 2020-07
2
GA 5752.5124 GB 10
Page 3
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 Packing ........................................................................................................................................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 ......................................................................................................................... 7
1.4.4 Versions .......................................................................................................................................8
1.4.4.1 Connection tubes with NIST screw connectors ......................................................... 9
2 Safety notes ............................................................................................................................................10
2.1 General .....................................................................................................................................................10
3 Initial operation, operation and use ......................................................................................................12
3.1 Equipment inspection ............................................................................................................................... 12
3.2 Connection tube with gas probe and NIST screw connector ...................................................................12
4 Cleaning and disinfection ......................................................................................................................13
4.1 Basic instructions .....................................................................................................................................13
4.2 Cleaning ................................................................................................................................................... 14
4.2.1 General ......................................................................................................................................14
4.2.2 Cleaning procedure ....................................................................................................................14
4.3 Disinfection ............................................................................................................................................... 15
4.3.1 General ......................................................................................................................................15
4.3.2 Suitable disinfectants ................................................................................................................. 15
4.3.3 Disinfection procedure ...............................................................................................................15
5 Maintenance ............................................................................................................................................16
5.1 General .....................................................................................................................................................16
5.2 Period tests ..............................................................................................................................................16
5.3 Malfunctions and troubleshooting.............................................................................................................16
5.4 Repairs ..................................................................................................................................................... 17
5.5 Service hotline: ......................................................................................................................................... 17
GA 5752.5124 GB 10
3
Page 4
Table of contents
5.6 Sending in the device ............................................................................................................................... 17
6 Technical specifications ........................................................................................................................ 18
6.1 General .....................................................................................................................................................18
6.2 Ambient conditions ................................................................................................................................... 18
4
GA 5752.5124 GB 10
Page 5
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.
CAUTION!
Indicates a potential risk to property which
may result in property damage.
The text for the safety note
describes the type of risk and
how to avert it.
Tab. 1: Design of safety notes
GA 5752.5124 GB 10
5
Page 6
Introduction
4
1
Structure of notes
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 Packing
The packing is made of materials compatible with the environment. ATMOS will dispose of the
packing 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 for 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".
Packaging label.
Symbol for "Keep dry".
6
GA 5752.5124 GB 10
Page 7
Symbols Identification
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".
Labelling in compliance with the ISO 15223-1 standard.
Symbol for "Product number".
Introduction
Basic requirements
1
LOT
Tab. 3: Symbols
1.4 Basic requirements
1.4.1 Use in accordance with the intended purpose
Product
As per appendix IX of the Medical Products Directive 93/42/EU 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 shall 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.
Labelling in compliance with the ISO 15223-1 standard.
Symbol for „Batch number“.
1.4.2 Applicable standards
The product satisfies the basic requirements set forth in Annex I to the 93/42/EU 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.
1.4.3 Intended purpose
Name: Connection tubes with gas probe and NIST screw connection
GA 5752.5124 GB 10
7
Page 8
1
Introduction
Versions
Main function: Supply of compressed medical gases or vacuum to a device or a
controller for medical gases or vacuum
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
Connection between a terminal unit for compressed medical gases
or vacuum with a controller (e.g. vacuum controller) or a device
(e.g. anaesthetic machine)
The connection tube has a media-coded gas probe at one end and
a media-coded NIST screw connection at the other end. The
compressed medical gases or vacuum are extracted from a gastype-specific terminal unit of a central gas supply system by the gas
probe of the connection tube being inserted into the terminal unit.
The NIST screw connection of the connection tube is connected to
a device suitable for the combination. The permitted supply
pressure is between 400 kPa and 500 kPa +/-10 % for compressed
gases and -100 kPa to -60 kPa for a vacuum.
(< 30 days)
practices which do have a central gas supply system. The
application of the product may only be performed by medically
trained and introduced staff.
Contraindications: The connection tubes with gas probe and NIST screw connection
The product is: Not active
Sterility: No sterile product
Single-use product /
reprocessing:
1.4.4 Versions
Products and accessories are only permitted with the ISO colour coding. In Germany, Austria and
Switzerland, products with neutral colour coding are also permitted.
may not be used for the following purposes:
• 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
• With central gas supply systems with other supply pressures
than 400 kPa to 500 kPa +/- 10 % for compressed gases and
-100 kPa to -60 kPa for vacuum
• The undosed supply of medical gases (connection of tapping
units intended for this purpose is strictly necessary)
The product and parts of the accessories are reusable. For
information on reprocessing, cleaning and disinfection please see
the operating instructions.
8
GA 5752.5124 GB 10
Page 9
Connection tubes with NIST screw connectors
NOTE
Gas probes of DIN, BS, NFS and SS connection tubes can be rotated, gas probes
of MEDAP and UNI connection tubes cannot be rotated.
1.4.4.1 Connection tubes with NIST screw connectors
• Connection tubes for compressed air
• Connection tubes vacuum
• Connection tube oxygen
• Connection tubes laughing gas
Introduction
1
GA 5752.5124 GB 10
9
Page 10
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 the product, especially for oxygen and nitrous oxide, free of oils, greases,
lubricants and hand creams. Only use lubricants which are approved by ATMOS.
Observe fire protection regulations when dealing with combustion-enhancing
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 tight fitting and firm seat of the connector 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.
CAUTION!
Property damage!
Ensure that mechanical forces are not able to act on the connection tube, tube
connection and gas probe as this may cause malfunctions or damages.
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.
GA 5752.5124 GB 10
Page 11
Safety notes
General
WARNING!
Ambient conditions!
If the ambient temperature range specified for shipping, operation and/or storage
conditions is not maintained, then no guarantee can be assumed for the accuracy,
mechanical strength or tightness of the product.
DANGER!
Health hazard!
Pay attention that the product is connected to the appropriate gas type and that the
screw connection is firmly seated.
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.
2
WARNING!
Configuration of the overall 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 proper functionality and suitability of the product for each
intended application before every use, in particular connection parts, tightness and
suitability concerning material, work pressure and flow rate.
WARNING!
Risk of injury!
Products which are improperly mounted can loosen and cause injuries.
Mount the product properly.
CAUTION!
Property damage!
Never use contaminated gas probes.
CAUTION!
Property damage!
The plug-in valve may be damaged if the wrong gas probe is connected.
CAUTION!
Reduced performance!
Length and inside diameter of the product used may impair the maximum available
gas volume.
Check the gas volume available at the tapping unit.
GA 5752.5124 GB 10
11
Page 12
Initial operation, operation and use
1
5
4
2
3
3
Equipment inspection
3 Initial operation, operation and use
NOTE
Please consult the manufacturer's documents for the operation of the gas probe
and connected equipment.
3.1 Equipment inspection
Before using the unit for the first time, perform a wipe disinfection.
Examine the product for correct functioning and contamination or damages.
3.2 Connection tube with gas probe and NIST screw connector
Mounting of the connection tube with gas probe and NIST screw connector is described using the
FINA AIR B 800 gas probe unit.
Mounting the connection tube
Check whether the NIST nipple (1) of the
connection tube (2) is fitted with a flat seal
(3).
Plug the NIST nipple of the connection tube
into the NIST housing (4) of the tapping
unit.
Tighten the cap nut (5) by hand.
3
1
4
5
Insert the gas probe of the connection tube
into the terminal unit.
2
Fig. 1: Connection tube with NIST screw connec-
tor
12
GA 5752.5124 GB 10
Page 13
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 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. fluorites, 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.
GA 5752.5124 GB 10
13
Page 14
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 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 tensides and phosphates as the active cleaning agents.
In the event of heavily contaminated surfaces, use concentrated multi-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 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.
14
GA 5752.5124 GB 10
Page 15
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
• Quarternary ammonium compounds
• Guanidine derivatives
Cleaning and disinfection
Disinfection
4
Ingredient group Active ingredients
Aldehydes 2-ethyl-1-hexanal, formaldehyde, glutardialdehyde, glyoxal,
Quarternary ammonium
compounds
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
Alkyl-didecyl-polyoxethyl ammonium propionate, alkyl-dimethylalkylbenzyl 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)
GA 5752.5124 GB 10
15
Page 16
Maintenance
5
General
5 Maintenance
5.1 General
Maintenance, repairs and period 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 authorized 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 Period tests
At least every 5 years a test must be performed.
5.3 Malfunctions and troubleshooting
Defect Source of malfunction Corrective actions
No or reduced capacity on
tapping unit or anaesthetic
machine
Gas escapes at the NIST
screw connector
Gas escapes without
connected gas probe
Gas escapes from the
terminal units with connected
gas probe of the connection
tube
Gas probe of the connection
tube cannot be inserted into
the terminal unit
Tube is leaking Check connection tube, if
necessary, replace.
System is leaking Contact Technical Service.
Failure of central supply
system
Seal on the screw connector
defective
Screw connector not screwed
tightly
Seal on the terminal unit
defective
Incorrectly selected
connection tube and gas
probe or deformation of gas
probe
Terminal unit has the wrong
gas type
Contact Technical Service.
Replace seal.
Check screw connector and, if
necessary, tighten.
Contact Technical Service.
Continue supply using another
terminal unit.
Replace the seal on the plug-
in valve, if necessary, replace
the entire plug-in valve.
Check connection tube and
gas probe, if necessary, use
correct connection tube.
Use correct terminal unit.
16
Gas probe cannot be locked Defective or contaminated
Screw connector cannot be
tightened
Tab. 5: Corrective actions
GA 5752.5124 GB 10
Contact Technical Service,
terminal unit
Wrong screw connector has
been selected
Thread is damaged Contact Technical Service.
have terminal unit checked.
Check corresponding media
for screw connector, if
necessary, replace connection
tube.
Page 17
5.4 Repairs
The following may require repairs from the manufacturer or an authorized 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 16].
If defects are detected the product may not be used any longer.
Make a note of the deficiencies and the REF number on the data plate and inform the responsible
ATMOS Service.
Observe the information in chapter Sending in the device [ page 17].
5.5 Service hotline:
+49 7653 689-0
Maintenance
Repairs
5
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.
GA 5752.5124 GB 10
17
Page 18
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%
Nominal supply pressure for vacuum -100 kPa to -40 kPa
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
18
GA 5752.5124 GB 10
Page 19
Notes
Page 20
Manufacturer:
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
79853 Lenzkirch
GERMANY
Phone: +49 7653 689-0
www.atmosmed.com
Loading...