DEHAS DEMAND VALVE QualityFlow User manual

Operating Instructions
DEMAND VALVE QualityFlow
0482
Keep these instructions!
Version 3.1.
DEHAS Medical Systems GmbH
Wesloer Straße 107-109
23568 Lübeck OT Schlutup, Germany
Phone: [phone]
Fax: [phone]
www.DEHAS.de

1
Content
1 Preface .......................................................................................................................................... 2
2 Basic Requirement ........................................................................................................................ 2
2.1 Intended use............................................................................................................................ 2
2.2 Accessoires / Variants ............................................................................................................. 2
2.3 Applied standards.................................................................................................................... 3
3 Safety Information –Warning, caution and labeling information................................................ 3
4 Before first of use.......................................................................................................................... 5
4.1 Safety Information................................................................................................................... 5
5 Technical data ............................................................................................................................... 7
5.1 Variants.................................................................................................................................... 7
6 Commissioning, installation and service life................................................................................. 8
6.1 Commissioning ........................................................................................................................ 8
6.2 Application notes..................................................................................................................... 8
6.3 Installation............................................................................................................................... 8
6.3.1 Cylinder supply → Ventilation bag.................................................................................. 8
6.3.2 Central gas supply → Ventialtion bag ............................................................................. 8
6.4 After the use............................................................................................................................ 9
6.4.1 Cylinder supply → Ventilation bag.................................................................................. 9
6.4.2 Central gas supply → Ventilation bag ............................................................................. 9
7 Cleaning instructions..................................................................................................................... 9
7.1 Cleaning and Disinfection........................................................................................................ 9
8 Inspection & maintenance.......................................................................................................... 11
8.1 General.................................................................................................................................. 11
8.2 Maintenance and inspections ............................................................................................... 11
8.2.1 Functional test............................................................................................................... 11
8.2.2 Leak test ........................................................................................................................ 11
9 Warranty ..................................................................................................................................... 11
10 Return of goods........................................................................................................................... 12
11 Disposal....................................................................................................................................... 12
12 Manufacturer Information.......................................................................................................... 15
*Technical changes reserved!

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1Preface
These operating instructions are intended to provide you with assistance in using the
QualityFlow demand valve. The operating instructions are divided into individual chapters.
Please note:
•Read these instructions for use carefully and completely before using the product for
the first time.
•Always act in accordance with the instructions given in the operating manual.
•Keep these operating instructions close to the product.
2Basic Requirement
Intended use:
According to Annex IX of Directive 93/42/EEC concerning medical devices, this product
belongs to Class IIb. According to this directive, only medical professionals who have been
instructed in the use of the product by an authorized person may use this product. This
product is to be used exclusively for human medical purposes.
2.1 Intended use
The demand valve is used for the application of 100 vol% oxygen during manual ventilation
with the resuscitator bag, as well as during direct non-invasive ventilation with the
resuscitator mask in spontaneously breathing patients.
2.2 Accessoires / Variants
Article No.
GTIN / UDI
Description
D-2522001
4251411701314
Adapter medium, white (24/28 mm)
D-2522002
4251411701321
Adapter large, white (26/32 mm)
D-2522003
4251411701338
Adapter small, white (15/22 mm)
D-2522004
4251411701598
Adapter Laerdal/VBM f. Demand valve
25/32 mm
D-2522005
4251411701574
Adapter Ambu, white (28/32 mm)
D-2522006
4251411702908
Adapter demand valve, white 22-23-30
mm

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2.3 Applied standards
The product complies with the essential requirements according to Annex I of Directive
93/42/EEC (Medical Device Directive) as well as the applicable national regulations such as
the Medical Devices Act (MPDG).
Standard / Norm
Titel
DIN EN ISO 780
Packaging - Shipping packaging - Graphic symbols for handling and
storage of packages
DIN EN ISO 15223-1
Medical devices - Symbols, marking and information to be used in
the labelling of medical devices - Part 1: General requirements
DIN EN 1041
Provision of information by the manufacturer of medical devices
DIN EN ISO 5359
Anesthesia and respiratory equipment - Low-pressure hose line
systems for use with medical gases
DIN EN ISO 14971
Medical devices - Application of risk management to medical
devices
DIN EN 62366-1
Medical devices - Part 1: Application of fitness for use to medical
devices
ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management system
3Safety Information –Warning, caution and labeling information
Symbol
Description
The symbol indicates that the device complies with the
requirements of Regulation 93/42/EEC concerning medical devices
and all applicable international standards.
Indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.
When this symbol is used, it indicates a potentially hazardous
situation which, if not avoided, may result in property damage.
Manufacturer
Date of manufacture
Store in a dry place / Protect from moisture / wetness

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Unique Device Identification
Medical device
Serial number
Reference number / Article number
Product non-sterile
Temperature limit
or
Refers to the need for the user to consult the instructions for use.
Follow the instructions for use
Do not dispose of in household waste
Do not use if packaging is damaged
Moisture limitation during storage
Latex free product
Do not use oil

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4Before first of use
Read all instructions before use!
These operating instructions provide qualified personnel with instructions for installation and
operation. It serves your safety and protects the product from damage. If you do not
understand any information or instruction in this instruction manual, do not use the product
and contact your supplier.
4.1 Safety Information
WARNINGS
•Intended use / user
•The demand valve may only be operated by medical professionals under the
direct supervision of a licensed physician.
•As with all medical products, this demand valve could cause injury to the patient if
used without precise knowledge of its operation.
•The demand valve may only be used for the purpose described in these
instructions for use.
•The configuration of the overall system and the verification of its functionality are
the overall responsibility of the medical personnel.
•Functionality and suitability of the product for the intended use must be checked
by the user before each use.
•Check the gas cylinder or the supply line accordingly before use.
•The demand valve has a gas-specific connection. The connection must not be
modified and adapted to other gases or connection systems.
•If you use a cylinder and a pressure reducer, ensure that the product is connected
to the pressure reducer and the cylinder valve is properly opened before starting
therapy.
•Ensure that the supply pressure is within the range specified in the technical data
of the demand valve.
•Maintenance / Repair
•Maintenance, repairs and periodic inspections may only be carried out by
authorized specialist personnel who have the appropriate expertise and are
familiar with the product.
•Danger: Fire and explosion hazard!
•Air, oxygen and oxygen mixtures react explosively with oils, greases and
lubricants. As a result of the compressed gas, there is a risk of fire and explosion.
The product must be kept free of oils, greases, lubricants and hand creams.
•When handling combustion-promoting gases, observe the fire protection
regulations.
•If leaks are detected in the product, contact the customer service immediately.
•When attaching accessories, check the connecting piece for tightness and secure
seating!

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•There is a fire hazard due to escaping oxygen! DO NOT use near flames,
flammable / explosive substances, vapors or gases.
•Never smoke in an area where oxygen is administered.
•Do not exceed maximum operating pressure and maximum operating
temperature.
•Danger: Product defects!
•The use of incorrect spare parts and accessories can lead to personal injury or
functional failure. Only use original accessories and spare parts!
•Danger: Risk of injury!
•A worn or damaged product can lead to injuries. Only use the product when it is
in perfect condition!
•Do not use the product under any circumstances if it is contaminated!
•Danger: Damage to property!
•No mechanical forces may act on the product with accessories to prevent
malfunctions or damage!
•Danger: Ambient conditions!
•If the ambient temperature range is exceeded or undershot during transport
and/or storage conditions, no warranty can be given for the accuracy, function,
mechanical strength as well as the tightness of the product.
•Danger: Health hazard!
•When using oxygen, a kink in the connection hose can interrupt the oxygen
supply. The connection hose must not be kinked!
•An improperly fastened product can come loose and cause injury.
•Danger: Reduction in performance!
•Regularly check the available gas quantity at the tapping device!
•Cleaning!
•NOT suitable for sterilization.
•Never immerse the complete demand valve in liquids.

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5Technical data
Product
QualityFlow
Classification according to Medical Device
Directive 93/42/EEC
Class IIb
Requirement
According to DIN EN ISO 5359
Connections
Connection between demand valve and hose:
M12x1
Connection between hose and supply:
M12x1 or tapping plug acc. to DIN 13260 / part
2
Operating temperature
-20 to +70°C
Required operating pressure
280 to 550 kPa (2.0 to 5.5 bar)
Maximum delivery capacity
200 l/min at -20° and 450 kPa
Set pressure
-0.5 kPa (-0.5 mbar)
Filter
25 micron
Transport / storage temperature in original
packaging
-20°C to +40°C
Marking:
Serial number, LOT, GTIN / UDI, CE marking, date of manufacture, expiration date, safety
symbols.
5.1 Variants
GTIN / UDI
Description
4251411700645
Demand valve white (without connection hose)

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6Commissioning, installation and service life
CAUTION
•Please refer to the manufacturer's documentation for information on the
operation of the connecting devices, including the ventilation bag.
•Never open the demand valve. Otherwise, the correct function is no longer
ensured!
6.1 Commissioning
Product verification
•Before first use, the product must be subjected to wipe disinfection.
•Check that the product is in working order and does not show any contamination or
damage.
6.2 Application notes
Triggered by the negative pressure of the deploying ventilation bag, the demand valve
provides an O2 flow until the bag is filled. (Follow the instructions for use of the ventilation
bag).
•Not suitable for invasive use directly on the tube!
•Never open the demand valve! Otherwise, the correct function is no
longer ensured and the product must be returned to the manufacturer
for inspection.
6.3 Installation
6.3.1 Cylinder supply → Ventilation bag
1) Connect the demand valve with connection hose via oultlet probe to an O2 pressure
reducer of the O2 Cylinder supply bottle (characteristic value 400 to 500 kPa,
corresponding to 4-5 bar downstream pressure)
2) Insert the demand valve into the suction opening of the ventilation bag using the
corresponding adapter.
6.3.2 Central gas supply → Ventialtion bag
1) Connect the demand valve with connection hose via outlet probe to the plug in O2
coupling of central gas supply (characteristic value of the central gas supply 400 to 500
kPa, corresponding to 4-5 bar).
2) Insert the demand valve into the suction opening of the ventilation bag using the
appropriate adapter.

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6.4 After the use
6.4.1 Cylinder supply → Ventilation bag
1) Close the valve of the O2 bottle and disconnect the connecting hose with outlet probe
from the pressure reducer of the O2 bottle.
2) Pull the demand valve out of the suction opening of the ventilation bag.
3) Prepare the demand valve according to the cleaning and care instructions.
6.4.2 Central gas supply → Ventilation bag
1) Disconnect the connecting hose with outlet probe from the the plug in O2 coupling of
central gas supply.
2) Pull the demand valve out of the suction opening of the ventilation bag.
3) Prepare the demand valve according to the cleaning and care instructions.
7Cleaning instructions
CAUTION
•Please make sure to observe the application instructions of the detergent and
disinfectant manufacturer as well as the currently applicable hygiene regulations for
the hospital.
•Use surface disinfectants based on aldehydes and quaternary ammonium
compounds; these are included in the current list of the "German Society for Hygiene
and Microbiology".
•Caution, improper cleaning and disinfection may result in property damage.
•NOT suitable for sterilization.
•Never disassemble the product.
•NEVER immerse the device in liquids.
•DO NOT use strong solvents or abrasive cleaners.
•DO NOT clean with aromatic hydrocarbons.
7.1Cleaning and Disinfection
Manufacturer:
DEHAS Medical Systems
GmbH Wesloer Str. 107-109
23568 Lübeck, OT Schlutup,
Germany
Sterilization method:
N/A
The product is not
intended for
sterilization process.
Produkt: QualityFlow

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WARNING:
Do not use strong solvents or abrasive cleaners.
Do not clean with aromatic hydrocarbons.
Do not bring into contact with oil, grease or flammable liquids - there is an
increased risk of fire.
Do not autoclave!
Do not sterilize!
Do not immerse in liquids!
The instructions listed have been validated as SUITABLE by the medical device manufacturer for
preparing a medical device for reuse. The reprocessor is responsible for ensuring that the actual
reprocessing performed with the equipment, materials, and personnel used in the reprocessing
facility achieves the desired results.
INSTRUCTIONS
The outside of the unit must be wiped clean at regular intervals or at the latest
after each patient in accordance with the applicable hygiene standard.
Preparation for
cleaning and
disinfection:
Disconnect all gas connections and equipment before cleaning and disinfecting.
Cleaning: Manual
For this process:
1. Wipe the surfaces of the device and accessories with a lint-free cloth
soaked in water and detergent and wrung out. Do not allow any liquid to
get inside the Quality Flow demand valve.
2. Wipe again with a dry, lint-free cloth.
Disinfection: Manual
3. Wipe the outside of the Quality Flow demand valve and the adapter with
a lint-free cloth moistened with a non-oxidizing disinfectant.
4. Observe the exposure time of the disinfectant manufacturer according to
the required spectrum of activity.
Drying:
5. After the exposure time specified by the disinfectant manufacturer, wipe
dry with a dry, lint-free, low-germ cloth.
Manufacturer's
Recommendation:
The manufacturer recommends the use of the disinfectant Bacillol ® 30 Foam,
Bacillol ® 30 Tissues, Bode Chemie GmbH & Co. The current product data sheet of
the disinfectant manufacturer must be observed.
Maintenance, control
and testing:
A visual and functional check must be performed after each cleaning and
disinfection.
Packaging:
▪The device must be kept in the packaging validated by DEHAS for
transport.
Storaging:
▪Temperature: -20°C to +40°C
▪Store in a dry place.
▪Store the product in a dry, clean place free from lubricants, oil and other
contaminants.
Transport:
▪Temperature: -20°C to +40°C
Additional information:
N/A
Contact:
DEHAS Medical Systems GmbH, Wesloer Straße 107-109, 23568 Lübeck, OT
Schlutup, Germany
Tel.: [phone], Fax: [phone], E-Mail: in[email protected]
After each cleaning and disinfection, a visual and functional check must be carried out.

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8Inspection & maintenance
8.1 General
Maintenance, repairs and periodic inspections may only be carried out by persons who have
the appropriate expertise and are familiar with the product.
However, the product must be cleaned regularly after use, checked for signs of damage and
its performance must be checked. Furthermore, all seals used in the product must be checked
regularly for perfect condition and correct function and replaced if necessary.
8.2 Maintenance and inspections
The demand valve and connection hose must be subjected to a visual and functional check
before each use.
The product should be subjected to a function and leak test at least once a year.
The deman valve does not have any parts that require maintenance. If the performance data
are found to be impaired during the function and leak test, please contact your dealer.
If a connection hose is supplied, the flat seal in the M12x1 screw connection must be replaced
every 2 years.
8.2.1 Functional test
Squeeze and release the resuscitation bag. With the demand valve connected, the bag should
deploy in approx. 1 second.
8.2.2 Leak test
Connect the demand valve to the pressure reducer and open the gas supply to the O2 cylinder.
No oxygen should escape audibly.
9Warranty
The warranty period for the Product is 12 months from the date of sale, subject to the
following terms and conditions:
Should any defect in the Product occur within the applicable period, Dealer, upon written
notice thereof and upon proof that the Product has been stored, installed, maintained and
operated in accordance with the instructions and in accordance with standard industry
practices, and that no alterations, substitutions or modifications have been made to the
Product, shall correct such defects by appropriate repair or replacement at its own expense.
ORAL STATEMENTS DO NOT CONSTITUTE A WARRANTY.
The dealer is not authorized to make any oral warranties about the product described in this
manual, and such statements are not binding and are not part of the sales contract. Therefore,
this second statement is the final, complete and exclusive representation of the terms of the
contract.
- Subject to technical changes!

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10 Return of goods
Please contact your dealer in this regard. They will coordinate the return shipment for you. It
is important that you provide a description of the fault so that the return shipment can be
processed in a targeted manner. All returns must be shipped in sealed containers to prevent
damage. The dealer is not responsible for products damaged during shipping.
11 Disposal
CAUTION
•Danger of infection! The product or parts of it may be contaminated after use. Clean
and disinfect the product before disposal.
At the end of the service life:
Have the demand valve disposed of properly after consulting the relevant disposal company.
Observe the applicable legal regulations.

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EG-Konformitätserklärung
EC Declaration of Conformity
DEHAS Medical Systems GmbH| Wesloer Str. 107-109 | 23568 Lübeck, Germany
Produkt/
Medical device:
Demandventile/ Demand valves
Artikelnummern/
Item numbers:
Siehe Anhang
See attached list
Klassifikation/
Classification:
IIb
Regel 11, Anhang IX, Medizinprodukterichtlinie 93/42/EWG
Rule 11, Annex IX of Medical Device Directive 93/42/ECC
Wir erklären hiermit in alleiniger Verantwortung, dass das oben genannte Produkt mit den
grundlegenden Anforderungen gemäß Anhang 1 der Medizinprodukterichtlinie 93/42/EWG
übereinstimmt. Alle Belegdokumente werden in den Räumlichkeiten des Herstellers und der
benannten Stelle aufbewahrt.
We hereby declare under our sole responsibility that the above product is in conformity with the basic
requirements according to Annex 1 of the Medical Device Directive 93/42/EEC. All supporting
documents are kept on the premises of the manufacturer and the notified authority.
Konformitätsbewertungsverfahren/
Conformity assessment route:
Anhang II (ohne Abschnitt 4) der
Medizinprodukterichtlinie 93/42/EWG (Vollständiges
Qualitätssicherungssystem)
Annex II (without section 4), Medical Device Directive
93/42/EEC (Full quality assurance system)
Angewandte Normen/
Applied standards:
EN 1041
EN ISO 5359
ISO 10993-1
EN ISO 14971
ISO 15223-1
Benannte Stelle/ Notified Body:
DNV Medcert GmbH, Pilatuspool 2, 20355 Hamburg,
Germany
Kenn-Nummer/ ID number:
0482
EG Zertifikats-Nr./ EC Certificate no.:
4153GB410200327
Ausstellungsdatum/ Date of issue:
2020-03-27
Ablaufdatum/ Expiry date:
2024-05-27
Lübeck, 26.08.2020
Jens Meincke, Quality Manager
DEHAS Medical Systems GmbH

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Anhang EG-Konformitätserklärung
Attachment EC Declaration of Conformity
Produktliste / List of products
Article No.
GTIN / UDI
Description
D-DV-W-M12x1
4251411700645
Demand valve white (without connection
hose)
D-2522001
4251411701314
Adapter medium, white (24/28 mm)
D-2522002
4251411701321
Adapter large, white (26/32 mm)
D-2522003
4251411701338
Adapter small, white (15/22 mm)
D-2522004
4251411701598
Adapter Laerdal/VBM f. Demand valve
25/32 mm
D-2522005
4251411701574
Adapter Ambu, white (28/32 mm)
D-2522006
4251411702908
Adapter demand valve, white 22-23-30
mm
Ende der Liste / End of list

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12 Manufacturer Information
Manufacturer: DEHAS Medical Systems GmbH
Wesloer Straße 107-109
23568 Lübeck
Tel: [phone]
Fax: [phone]
Email: [email protected]
Homepage: www.dehas.de
Distributed by: DEHAS Medical Systems GmbH
Wesloer Straße 107-109
23568 Lübeck
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Homepage: www.dehas.de
Rev. 3.1. Stand 07/2023