Weinmann OXYWAY User manual

OXYWAY
Pressure reducer / Manodétendeur
Fix I, Fix III (fixed / réglage fixe)
Fine I (variable / réglage en continu)
Fast I, Fast II, Fast III (multistep / réglage par paliers)
Instructions for Use for Devices from Serial Number 1810000
Mode d'emploi pour appareils à partir du numéro de série 1810000

English 3
Français 37

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OXYWAY EN 3
1 Introduction 5
1.1 Intended use ................................................................................. 5
1.2 Function ........................................................................................ 5
1.3 Operator and user qualification ...................................................... 5
1.4 Contraindications .......................................................................... 6
1.5 Side effects ................................................................................... 6
2 Safety 7
2.1 Safety information ......................................................................... 7
2.2 General instructions ...................................................................... 9
2.3 Warnings in this document .......................................................... 10
3 Description 11
3.1 Overview ..................................................................................... 11
3.2 Labels on the product .................................................................. 14
4 Preparation and operation 15
4.1 Installing the pressure reducer ..................................................... 15
4.2 Removing the pressure reducer .................................................... 16
4.3 Inserting the pressure reducer ...................................................... 17
4.4 Setting the inhalation flow .......................................................... 19
5 Hygienic preparation 21
5.1 General instructions .................................................................... 21
5.2 Intervals ...................................................................................... 21
5.3 Hygienic preparation of pressure reducers .................................... 22
6 Function check 23
6.1 Intervals ...................................................................................... 23
6.2 Performing a function check ........................................................ 23
6.3 Repairing leaks ............................................................................ 25
7 Faults 26
8 Maintenance 27
8.1 General instructions .................................................................... 27
8.2 Intervals ...................................................................................... 27
8.3 Sending in device ........................................................................ 27
8.4 Replacing the disposable filter ..................................................... 28

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8.5 Replacing the sealing ring ........................................................... 29
9 Storage 30
9.1 General instructions .................................................................... 30
9.2 Storing the device ....................................................................... 30
10 Disposal 31
11 Technical data 32
12 Scope of supply 35
12.1 Standard product ........................................................................ 35
12.2 Accessories and spare parts ......................................................... 35
13 Appendix 36
13.1 Warranty ..................................................................................... 36
13.2 Declaration of Conformity ............................................................ 36

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OXYWAY EN 5
1 Introduction
1 Introduction
1.1 Intended use
The pressure reducers are used to supply medical oxygen at
reduced pressure for various medical and therapeutic devices as
well as for supplying oxygen to patients via application systems
(e.g., nasal cannulas, masks, humidifiers). The pressure reducers
are intended for connection to high-pressure oxygen cylinders
(cylinder pressure up to 20,000 kPa = 200 bar).
The pressure reducers are not intended for operation of surgical
instruments.
1.2 Function
The oxygen from the oxygen cylinder enters the pressure reducer
through the connecting bolt with hand-screwed connection and
two filters in series.
When the cylinder valve is open, the cylinder pressure can be read
off the contents indicator.
Depending on the type of device, the cylinder pressure is reduced
to between 0.5 bar and max. 6 bar in the pressure reducer.
All pressure reducers are protected against excessive pressure by a
safety valve.
1.3 Operator and user qualification
As the user, you must be fully familiar with the correct operation
of this medical device. Observe the statutory requirements for
operation and use (in Germany, particularly the German
regulations governing owners/operators of medical devices
(MPBetreibV)).
General recommendation: You should seek instruction on the
correct handling, use, and operation of the medical device from a
person authorized by WEINMANN Emergency.

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1 Introduction
1.4 Contraindications
There are no known contraindications.
1.5 Side effects
Concerning side effects which may occur during inhalation of
medical oxygen, please consult your doctor or pharmacist and read
the section entitled “medical oxygen” in the enclosed note on use.

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2 Safety
2 Safety
2.1 Safety information
Read these instructions for use carefully. They form part of the
device described and must be available at all times.
Only use the device for the intended use (see “1.1 Intended use”,
page 5).
For your own safety as well as that of your patients, and in
accordance with the requirements of Directive 93/42/EEC, please
observe the following safety instructions.
2.1.1 How to use the device
Warning Risk of injury from pressure blows!
Pressure blows can cause the pressure reducer to spontaneously
combust, resulting in injuries to the patient, user, or bystanders.
Open the valve of the oxygen cylinder slowly.
If possible, set the inhalation flow to 0 after operation.
Risk of injury from uncontrolled oxygen output!
Not all outlets have a check valve which closes the outlets
automatically when a connection hose (pressure outlet) or
inhalation accessories (inhalation outlet) are removed. As a result,
oxygen can escape unchecked and raise the oxygen content of the
immediate surroundings. In case of insufficient ventilation, this
may cause fires, resulting in injuries to the patient, user, and
bystanders.
Close the oxygen cylinder when changing the device.
Vent the system.
Risk of injury from insufficient oxygen supply!
In cases with an oxygen requirement of more than 90 l/min, there
is a risk of an insufficient oxygen supply, which puts the patient at
risk if the pressure outlet and inhalation outlet are running at the
same time.
Do not use the pressure outlet and inhalation outlet at the
same time.

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2 Safety
Notice Turning the indicator (Fix and Fast only) under pressure will
shorten the life expectancy of the indicator’s turning
function!
Turning the indicator when the system is under pressure can cause
signs of wear on the device.
To extend the service life of the indicator’s turning function,
avoid turning the indicator under pressure.
2.1.2 Safe handling of oxygen
Warning Risk of injury if oxygen is used in combination with
combustible substances!
The combination of oxygen and combustible substances may lead
to spontaneous, serious fires. Where ventilation is inadequate,
oxygen may build up in the environment (e.g., clothing, hair, bed
linen) and cause fires and thereby injuries to the patient, user, and
bystanders.
Do not smoke.
Do not use open flames.
Ensure adequate ventilation.
Keep the device and all the screwed unions completely free
from oil and grease.
Do not immerse the device in a disinfectant or any other
cleaning solution.
Wash your hands before working on the oxygen supply.
Do not point the oxygen cylinder connection towards yourself
or anyone else.
Risk of injury from highly compressed oxygen!
When combined with highly compressed oxygen, hydrocarbon
compounds can cause explosions.
Wash you hands before handling the pressure reducer and the
oxygen cylinder.
Do not use any oil, grease, cleaning alcohols, hand cream, or
adhesive plasters.
Risk of injury if oxygen escapes from damaged oxygen
cylinders or pressure reducers!
Oxygen can escape unchecked from damaged oxygen cylinders
or pressure reducers. This may lead to explosions and cause injury
to the patient, user, and bystanders.
Tighten or loosen all screwed unions on the oxygen cylinder
and on the pressure reducer by hand only.
Secure the oxygen cylinder so that it cannot fall over.

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OXYWAY EN 9
2 Safety
2.2 General instructions
• If third-party items are used, malfunctions may occur and
fitness for use may be restricted. Biocompatibility requirements
may also not be met. Please note that in such cases, any
warranty claim and liability will be voided if neither the
accessories recommended in the instructions for use nor
genuine replacement parts are used. Third-party items may
increase the radiation output or reduce the interference
immunity.
• Repairs, servicing and maintenance should only be carried out
by the manufacturer, WEINMANN Emergency, or by a
technician expressly authorized by WEINMANN Emergency.
• The manufacturer, WEINMANN Emergency, guarantees the
compatibility of the device and all components or accessories
connected to the patient prior to use. Only have modifications
to the device carried out by the manufacturer,
WEINMANN Emergency, or by a technician expressly
authorized by WEINMANN Emergency. Do not use any articles
from third parties.
• Any constructive changes made to the device may put the
patient and the user at risk and are not permitted.
• Please observe the section on hygienic preparation in order to
avoid infection or bacterial contamination (see “5 Hygienic
preparation”, page 21).
• Also observe the respective instructions for use for the
components and the accessories.
• Always carry out a function check before using the device (see
“6.2 Performing a function check”, page 23).

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2 Safety
2.3 Warnings in this document
Warnings are used to flag up safety-relevant information.
You will find a warning preceding any action that entails a hazard
for persons or equipment.
Warnings consist of
• the warning symbol (pictogram),
• a signal word designating the hazard level,
• information about the hazard, and
• instructions for avoiding the hazard.
The warnings appear in three hazard levels depending on the
degree of danger:
Danger!
Designates an extremely dangerous situation. Failure to observe
this warning may lead to serious, irreversible injury or death.
Warning!
Designates an extremely dangerous situation. Failure to observe
this warning may lead to serious, irreversible or fatal injury.
Caution!
Designates a dangerous situation. Failure to observe this warning
may lead to minor or moderately serious injury.
Notice!
Indicates a hazardous situation. Failure to observe this warning
may lead to damage to equipment.
Designates useful information relating to a particular action.

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OXYWAY EN 11
3 Description
3 Description
3.1 Overview
3.1.1 Fixed pressure reducers (Fix)
1
2
3
4
5
No. Designation Description
1 Rotatable contents indicator Indicates cylinder pressure.
2 Connecting bolt with hand-screwed
connection Connects the pressure reducer to the oxygen cylinder.
3 Safety valve Protects against excessively high pressure.
4 Disposable filter Protects against external soiling.
5
Possible outlets:
• Inhalation outlet
(UNF 9/16” thread)
Connects the pressure reducer with connected
accessories (e.g., nasal cannulas, masks, intermediate
humidifiers).
• Pressure outlet
(G 3/8” thread)
Connects the pressure reducer with a connected
device.

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3 Description
3.1.2 Variable pressure reducers (Fine)
1
1
2
3
4
5
6
7
No. Designation Description
1 Contents indicator Indicates cylinder pressure.
2 Connecting bolt with hand-screwed
connection Connects the pressure reducer to the oxygen cylinder.
3 Handwheel Used to set inhalation flow.
4 Safety valve Protects against excessively high pressure.
5 Disposable filter Protects against external soiling.
6 Inhalation outlet
(UNF 9/16” thread)
Connects the pressure reducer with connected
accessories (e.g., nasal cannulas, masks, intermediate
humidifiers).
7 Flow indicator Shows the set inhalation flow on the OXYWAY Fine.

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OXYWAY EN 13
3 Description
3.1.3 Multistep pressure reducers (Fast)
1
2
3
4
5
6
7
No. Designation Description
1 Rotatable contents indicator Indicates cylinder pressure.
2 Connecting bolt with hand-screwed
connection Connects the pressure reducer to the oxygen cylinder.
3 Handwheel Used to set inhalation flow.
4 Safety valve Protects against excessively high pressure.
5 Disposable filter Protects against external soiling.
6 Inhalation outlet
(UNF 9/16” thread)
Connects the pressure reducer with connected
accessories (e.g., nasal cannulas, masks, intermediate
humidifiers).
7 Pressure outlet
(G 3/8” thread)
Connects the pressure reducer with a connected
device.

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3 Description
3.2 Labels on the product
1
2
5
4
3
No. Symbol Description
Device information label
1
Article number
Serial number (see engraving on housing)
P1 Maximum permissible input pressure
P2 Working pressure of pressure reducer
Q1 Maximum output at inhalation outlet
Observe the instructions for use.
CE mark (confirms that the product complies with the applicable European
directives)
Other labels and symbols
2 xx l/min Maximum output at pressure outlet
3
The pressure reducer must not come into contact with flammable substances
(oil, alcohol, grease, etc.) as there is a risk of explosion when such substances
react with oxygen.
4 Replace the disposable filter every 2 years.
5 Service label: Indicates when the next maintenance is required.
REF
SN

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OXYWAY EN 15
4 Preparation and operation
4 Preparation and operation
4.1 Installing the pressure reducer
1. Briefly open the valve of the oxygen cylinder in order to blow
away any particles of dust.
2. Close the valve on the oxygen cylinder.
3. Remove any soiling on the connection threads of the oxygen
cylinder and the pressure reducer thoroughly using a lint-free,
dry or moistened cloth.
4. Check that the disposable filter is clean.
5. If the disposable filter is dirty: Replace the disposable filter
(see “8.4 Replacing the disposable filter”, page 28).
6. Screw the hand-screwed connection onto the valve of the
oxygen cylinder.
7. Screw the connection tight by hand.
Risk of injury from flying particles of dust!
When opening the oxygen cylinder, flying particles of dust may
get into the eyes.
Do not aim the cylinder towards people when opening it.

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4 Preparation and operation
8. Connect the pressure hose up to the pressure outlet.
or
If the device has an inhalation outlet: Connect up accessories.
9. Position the contents indicator such that it can be read easily
(Fix and Fast).
10. Perform a function check (see “6.2 Performing a function
check”, page 23).
Result The pressure reducer is installed.
4.2 Removing the pressure reducer
1. Close the oxygen cylinder.
2. Switch the connected device on and off again.
or
Set the inhalation flow until the contents indicator shows
0bar.
The system is now depressurized.

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4 Preparation and operation
3. Remove the pressure hose from the pressure outlet.
or
If the device has an inhalation outlet: remove the accessories.
4. Remove the hand-screwed connection from the valve of the
oxygen cylinder by hand.
Result The pressure reducer is removed.
4.3 Inserting the pressure reducer
Risk of injury from insufficient oxygen supply!
In cases with an oxygen requirement of more than 90 l/min, there
is a risk of an insufficient oxygen supply, which puts the patient at
risk if the pressure outlet and inhalation outlet are running at the
same time.
Do not use the pressure outlet and inhalation outlet at the
same time.

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4 Preparation and operation
Requirement • The pressure reducer is connected.
• On variable and multistep pressure reducers, the inhalation
flow is set to 0.
1. Turn the valve of the oxygen cylinder slowly through a
maximum of one turn in a counterclockwise direction.
The contents indicator displays the cylinder pressure.
2. Read off the cylinder pressure on the contents indicator of the
pressure reducer:
Oxygen = cylinder volume x cylinder pressure
3. When cylinder pressure is < 50 bar: Change the oxygen
cylinder.
4. Set the inhalation flow (see “4.4 Setting the inhalation flow”,
page 19).
5. After operation: Close the valve on the oxygen cylinder.
6. On variable and multistep pressure reducers: set the inhalation
flow to 0(see “4.4 Setting the inhalation flow”, page 19).
Risk of injury due to supply pressure being too low!
The supply pressure via the inhalation outlet is insufficient for the
operation of medical devices. This can result in malfunctions or
cause the medical devices to fail and injure the patient.
The inhalation outlet must not be used for the operation of
medical devices.
Cylinder
volume
x cylinder
pressure = oxygen supply
Example 1 10 l x 200 bar = 2,000 l
Example 2 10 l x 100 bar = 1,000 l
Risk of injury from escaping oxygen!
Even if the pressure reducer is completely closed, it is still possible
for a small quantity of oxygen to escape and cause fires.
Close the valve on the oxygen cylinder completely after
operation.

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4 Preparation and operation
4.4 Setting the inhalation flow
4.4.1 Fixed pressure reducers (Fix)
The inhalation flow rate is fixed and cannot be altered.
4.4.2 Variable pressure reducers (Fine)
1. Set the desired inhalation flow using the handwheel.
The flow indicator shows the set value.
2. Monitor the inhalation flow.
3. If necessary: Reset the inhalation flow.
Result The inhalation flow is set.
Risk of injury from insufficient oxygen supply!
In the case of relatively long, uninterrupted use, the inhalation
flow set gradually decreases as cylinder pressure drops. This can
put the patient at risk.
Monitor the inhalation flow regularly and, if necessary, reset it.

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4 Preparation and operation
4.4.3 Multistep pressure reducers (Fast)
1. Set the desired inhalation flow using the handwheel.
When doing so, note: The handwheel must click in correctly.
Result The inhalation flow is set.
Risk of injury from insufficient oxygen supply!
If the handwheel is midway between two different settings, no
oxygen is supplied to the patient. This can put the patient at risk.
Always ensure the handwheel clicks correctly into the desired
setting.