It is intended to be used for the short-term (maximum seven days) treatment of a single patient only, then discarded. MEDICAL INFORMATION Note: The mask system does not contain latex materials. If the patient has ANY reaction to any part of the mask system, discontinue use. CONTRAINDICATION • This mask may not be suitable for patients at risk of reflux of gastric contents. • Supervision is recommended if the patient has a reduced level of consciousness or is unable to remove the mask. WARNINGS • This mask is not suitable for providing life support ventilation. • This mask should be used only with CPAP or bilevel systems recommended by a physician or respiratory therapist. A mask should not be used unless the CPAP or bilevel system is turned on and operating properly. The exhalation device (vent) should never be blocked. The exhalation device must not be used for any medical procedure. Explanation of the Warning: CPAP or bilevel systems are intended to be used with special masks with connectors which have vent holes or separate exhalation devices to allow continuous flow of air out of the mask. When the CPAP or bilevel device is turned on and functioning properly, new air from the flow generator flushes the exhaled air out through the mask exhalation port. However, when the CPAP or bilevel device is not operating, enough fresh air may not be provided through the mask, and exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation. This warning applies to most models of CPAP or bilevel systems. Note: The mask includes an anti-asphyxia valve to help reduce rebreathing of exhaled air in the event that the CPAP or bilevel device is not operating properly. ResMed Hospital Full Face Mask E NGLISH• The exhaust vent flow is lower at lower mask pressures (see Pressure/Flow Curve). If the mask pressure during expiration is too low, there may not be enough exhaust vent flow to completely flush the air delivery hose of exhaled air before the start of the next inspiration. • Discard the mask if heavily soiled (eg, gastric contents). • If oxygen is used with the CPAP or bilevel device, the oxygen flow must be turned off when the flow generator is not operating. Explanation of the Warning: When the CPAP or bilevel device is not in operation, and the oxygen flow is left on, oxygen delivered into the ventilator tubing may accumulate within the flow generator enclosure. Oxygen accumulated in the CPAP or bilevel device enclosure will create a risk of fire. This warning applies to most types of CPAP or bilevel flow generators. • Please refrain from smoking while oxygen is in use. Note: At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure settings, patient breathing pattern, mask selection, and the leak rate. FITTING THE MASK The RESMED HOSPITAL FULL FACE MASK is supplied fully assembled. Note: Inspect the mask and replace it if any parts are damaged. 1 Connect one end of the main air tubing to the flow generator and the other end to the swivel. Turn the flow generator on. See “Technical Specifications” for information on the correct flow generator setting. 2 Place the mask cushion over the patient’s nose and mouth and pull the headgear over their head. 3 Gently tighten the headgear straps: a first, pull the side straps back along the side of the patient’s face. b then, adjust the top strap. headgear Back view Top view E Note: Make sure the side straps pass below the patient’s ears. The side arms on the mask will NGLISH bend back as you tighten the side straps. Do not over tighten the straps. 4 The fitted mask should look like this: 5 If the patient feels air leaks around the cushion, reposition the mask on the patient’s face to achieve a better seal. You may also need to readjust the headgear straps. REMOVING THE MASK To remove the mask, squeeze one of the quick release clips, and pull the mask and headgear up over the patient’s head. side strap top strap top strap side strap mask swivel headgear side arm make sure ports cap is closed main air tubing quick release clip E NGLISHDAILY CLEANING OF THE MASK (OR AS REQUIRED) Disconnect the main air tubing from the swivel. The RESMED HOSPITAL FULL FACE MASK may be cleaned and re-used on a single patient. This applies for a maximum of seven days, after which the mask should be discarded. The mask may be cleaned using a 70% v/v isopropyl alcohol swab or by wiping with a damp, soapy cloth. If using a damp cloth, use mild soap or diluted dishwashing detergent. Allow to air dry out of direct sunlight. Notes: • Do not disassemble the mask. • Discard the mask if heavily soiled. CAUTIONS • Do not use solutions containing bleach, chlorine, aromatics, moisturizers, antibacterial agents, or scented oils to clean any part of the system or air tubing. These solutions may cause damage and reduce the life of the product. • Do not expose any part of the syst...