ALPINOX Instruction Manual Rev 1

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 regulator 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.

In the event of a leak between the regulator and the cylinder valve, close the cylinder 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 indicates 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).

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. Contact AIR LIQUIDE Healthcare for support. SERVICE PERIOD 5 years USE Low or shelf

1) Regularly check the pressure gauge on the regulator (see fi . A ref 4) to ensure there is sufficie 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

1 year 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 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) 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.)

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).

Failure to respect these and the other cautions given within these instructions may result in severe injury.

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.

F. TROUBLESHOOTING GUIDE Type of malfunction

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

Cause

Gas flow inadequate or non-existent Valve closed or insuffici tly opened Cylinder not full or insuffici tly fille Valve does not function Pressure regulator does not function Downstream equipment does not function Wrong selected fl w

Remedy Open the cylinder valve Check the filling le el of the cylinder. Change the cylinder Change the cylinder Call your Rotarex technical support Change the downstream equipment 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

2. CLEANING AND DISINFECTION

B. USING THE REGULATOR

3 years 8hr / day

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 notified body 0029