Air Liquide MEDITEC CEODEUX ALPINOX User manual

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ALPINOX™
INSTRUCTION MANUAL
H) REGULATORY AND REFERENCE STANDARDS
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I) KEY
VIEW A VIEW B
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Ceodeux SA
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Air Liquide Healthcare Pty. Ltd.
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Office:
3/247 Coward Street
Mascot NSW 2020
To contact us call our toll free number: 1300 36 02 02
www.airliquidehealthcare.com.au
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e
NT-M73000096/Rev1.0/06.2015
alhorders @airliquide.com

ALPINOX™ regulators are medical pressure regulators for oxygen therapy in hospitals, for home
care and in ambulatory applications. They provide a regulated gas fl w from a high pressure
gas source to patients.
NOTE: Please read these instructions carefully before using the ALPINOX™
A. MOUNTING THE REGULATOR ON THE GAS CYLINDER
Carefully place the cylinder so as to avoid any risk of it falling; secure it in place if
possible. Before connecting the regulator, check that the high pressure valve connector
is free of dust or foreign matter (see fi . A ref. 1).
Make sure that hands and equipment are oil and grease free when handling the regu-
lator and the cylinder valve.
1 ) Ensure the cylinder valve is closed and remove the cylinder valve protection (if fit ed).
2) Remove the stopper from the yoke connection of the regulator (if fit ed).
Store it away in a clean location.
3) Ensure the cylinder valve and the regulator yoke connections are clean (no dust or foreign matter).
4) Check that the bodok seal on the regulator yoke connection is present and in good
condition (free of nicks, marks, etc).
5) Place the regulator yoke connection over the cylinder valve. Check that the pins match the
cylinder valve connection.
6) Hand-tighten the regulator to the cylinder valve using the yoke connection wing screw
(see fi . A ref 2).
DO NOT overtighten or tighten THE REGULATOR using a tool, as this may damage
the bodok seal.
If the bodok seal is missing or damaged, DO NOT use the regulator. The bodok seal
shall be replaced by an authorised person. Only use original parts provided by AIR
LIQUIDE Healthcare.
7) Open the cylinder valve SLOWLY. Ensure the system is gas tight and leak free.
8) If leaks are present, remove the regulator from the cylinder valve (see Section C), and repeat
steps 4 – 6. If leaks persist, DO NOT use the regulator. Contact AIR LIQUIDE Healthcare
9) Connect the patient device (tubing, canular, mask, etc) to the barbed outlet of the regulator
(see fi . A ref 3).
The fl w setting on the regulator must be in the “0” position before connecting it to
the cylinder and when slowly opening the cylinder valve.
The regulator barbed outlet must never be used for connecting and supplying other
equipment or devices other than those mentioned in these instructions. Only use
equipment that is compatible with medical oxygen.
B. USING THE REGULATOR
1) Regularly check the pressure gauge on the regulator (see fi . A ref 4) to ensure there is suf-
ficie t quantity of medical oxygen gas remaining in the cylinder. The coloured sections on
the gauge are an indication of the available contents:
•GREEN: Suffici t contents
•AMBER: Contents are getting low
•RED: Contents are low. Discontinue use and replace cylinder with a full one
In the event of a leak between the regulator and the cylinder valve, close the cylin-
der valve immediately and wait for the leak to stop. Ensure that there is no remaining
pressure in the regulator; the pressure gauge should read “0”. Under no circumstances
should the yoke connection be unscrewed or retightened if the pressure gauge indi-
cates a positive pressure. Follow step 7 in Section A).
2) Adjust to the desired gas fl w rate using the fl wrate selector knob (see fi . B ref 5).
Ensure that the position shown on the selector knob is not in-between the available
fl wrate settings. Doing so may interrupt the supply of medical oxygen.
Flow inaccuracies can be caused by back-pressure created by equipment connected
downstream of the regulator.
3) After use, slowly close the cylinder valve.
• Disconnect the tubing from the barbed outlet of the regulator
(see fi . B ref 6) and wait for the leak to stop.
• Ensure that the pressure reading on the pressure gauge is “0”.
• Set the fl wrate postion to “0” using the fl wrate selector knob (see fi . B ref 5).
Always use the regulator in well ventilated areas and away from oil and grease and
sources of heat and ignition. DO NOT smoke and keep away from combustible materials.
C. DISCONNECTING THE REGULATOR FROM THE GAS CYLINDER
1) Unscrew by hand the regulator from the cylinder valve using the yoke connection wing
screw (see fi . B ref 8).
2) Store the regulator in a dry and clean location after replacing the protective stopper on the
yoke connection (if available).
D. MAINTENANCE
1. USER OPERATIONAL CHECKS AND INSPECTIONS
The following checks should be performed each time the ALPINOX™ regulator is used;
• Check the condition of the inlet and outlet connections for secureness and signs of damage.
• Check that the bodok seal is present, free of nicks and marks and in good condition.
• Check that the pointer on the pressure gauge reads zero when the regulator is unpressurised.
• Check for any other physical damage to any part of the regulator.
• Check to ensure that the regulator is within its service date.
Note: If the regulator fails any of these checks, it must be removed from
service. Contact AIR LIQUIDE Healthcare for support.
2. CLEANING AND DISINFECTION
The ALPINOX™ regulator should only be cleaned with a damp cloth.
Disinfect using an instrument grade disinfectant – Instrumax Pink ARTG No. 135544 (Whitely
Medical) or equivalent as approved by the manufacturer.
In performing these tasks, be careful to avoid the ingress of moisture or cleaning solution into
the outlet and inlet connections.
It is strictly prohibited to use products containing ammonia or triethanolamine in
any concentration. DO NOT sterilize the ALPINOX™ regulator
3. STORAGE
Should the regulator not be required to be used for a period of time, it should be stored in a clean,
dry and secure place to prevent accidental damage. Ensure a dust free environment is maintained
to prevent the ingress of dust borne contamination to the inlet and outlet connections.
4. SCHEDULED MAINTENANCE
The frequency of this maintenance depends on the intensity of use. In any case, the interval
between scheduled maintenance shall not exceed fi e years. Scheduled maintenance shall only
be carried out by authorized persons that have been trained and certified by Ceodeux SA. Con-
tact AIR LIQUIDE Healthcare for support.
SERVICE PERIOD 5 years 3 years 1 year
USE Low or shelf 8hr / day Continuous
In case of ad-hoc repairs (due to accidental damage, abnormal variation in performance, etc.),
the ALPINOX™ regulator can be returned to AIR LIQUIDE Healthcare for service.
The ALPINOX™ regulator has a service life of 10 years. It shall be removed from service once its
period of use has reached this stage.
E. SAFETY CONDITIONS
1) Follow safety and handling instructions given on the gas cylinder label and gas SDS.
2) Do not use lubrication or any other sealing material on the regulator to aid connection
or to stop leaks.
3) Do not use the regulator if it has been or suspected to have been exposed to extreme
environmental conditions (temperature, humidity, etc.)
Failure to respect these and the other cautions given within these instructions may result in
severe injury.
F. TROUBLESHOOTING GUIDE
Type of malfunction Cause Remedy
Gas ow inadequate or non-existent Valve closed or insuffici tly opened Open the cylinder valve
Cylinder not full or insuffici tly fille Check the filling le el of the cylinder.
Change the cylinder
Valve does not function Change the cylinder
Pressure regulator does not function Call your Rotarex technical support
Downstream equipment does not function Change the downstream equipment
Wrong selected fl w Turn the fl w selector of the pressure
regulator
Connection not possible Connection incompatible with the valve Check the compatibility between the
cylinder valve and the pressure regulator
Connection damaged
Gas exists from vent holes Leak on seat
Call your AIR LIQUIDE Healthcare for support
Close the valve. Call AIR LIQUIDE Healthcare
for support
G. SYMBOLS
CE 0029 in compliance with European
Directive 93/42/EEC of June 14 1993 on medical devices, established by notified body 0029
TT 0029 in compliance with European
Directive 99/36/EEC of June 29 1999 on transportable pressure equipment, established by noti-
fied body 0029