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Resumen del manual
Oxygen accumulated in the ventilator enclosure will create a risk of fire. This warning applies to most types of ventilators. • Please refrain from smoking while oxygen is in use. • Leak or variation in the leak may cause mistriggering of the ventilator. • In determining ventilator settings, and in particular the tidal volume for volume-cycled ventilators, make appropriate allowance for mask dead space and leak. • As with all mask ventilation systems, significant leak may occur between the mask and the patient's face. The leak may vary depending on such factors as the patient ventilation, potentially producing profound hypoventilation or hyperventilation. The magnitude of this effect depends on the ventilator's ability to compensate. 1 English About the Mask • This mask does not contain latex, PVC or DEHP materials. If the patient has any reaction to any part of the mask system, discontinue use. • ResMed has tinted the Hospital NV Full Face Mask elbow blue to identify it as a non-vented mask for use with active exhaust non-invasive ventilator systems only. • The mask has a standard female 22 mm tapered fitting (ISO5356-1) for external connection to the ventilator. Fitting the Mask The ResMed Hospital NV Full Face Mask is supplied fully assembled. Note: Inspect the mask and replace It If any parts are damaged. 1 Select the correct mask size using the fitting template provided on the package. 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. Note: Make sure the side straps pass below the patient's ears. The side arms on the mask bend back as you tighten the side straps. Do not overtighten the straps, as air fills the dual-wall cushion and provides a comfortable seal. 4 Connect the mask to the ventilator system, and initiate air flow, according to the ventilator system operating instructions. 5 If 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. Cleaning the Mask This mask is disposable and should be discarded if heavily soiled. If lightly soiled, the mask may be cleaned by wiping with a 70% v/v isopropyl alcohol swab. Do not disassemble the mask. 2 CAUTIONS • Do not use solutions containing bleach, chlorine, aromatics, moisturisers, 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 system or tubing to direct sunlight as it may deteriorate. • If any visible deterioration of a component is apparent (cracking, tears, etc), replace the mask. Technical Specifications When determining ventilator settings, and in particular the tidal volume for volume cycled ventilators, make appropriate allowances for mask dead space and leak. Unintentional Mask Leak The Unintentional Mask Leak comprises leak between the cushion-frame and elbow-frame interfaces. Pressure (cm H2O): 4-20 20-30 Maximum leak (L/min): 6 12 Dead Space Dead space is the empty volume of the mask up to the elbow. The dead space of the mask varies according to cushion sizes but is less than 342 mL. Standards CE designation in accordance with EC directive 93/42/EEC, class Ila. EN ISO 14971, ISO 5356-1, ISO 594-1, ISO 10993-1 and ISO 13485. Operating Pressure 0 to 40 cm H2O Resistance Drop in pressure measured: at 50 L/min: 0.4 cm H2O, at 100 L/min: 1.2 cm H2O Dimensions H = 158 mm, W = 230 mm and D = 105 mm (Medium) Environmental Conditions Operating temperature: +5°C to +40°C Operating humidity: 10%-95% relative humidity non-condensing Storage and transport: -20°C to +60°C Storage and transport humidity: 10%-95% relative humidity non-condensing Disposal This mask contains no hazardous materials and may be disposed of in accordance with local environmental regulations. 3 English Symbols A Caution, consult accompanying documents [lot] Lot number [ref] Part number X Temperature limitation .0' Humidity limitation <9 Does not contain latex ml Manufacturer 2) Single use s Small ^M Medium L Large NV: Non-vented A Indicates a Warning or Caution and alerts you to a possible injury or explains special measures for the safe and effective use of the device. Ordering Information REF Item 60735 ResMed Hospital NV Full Face Mask, Small 60736 ResMed Hospital NV Full Face Mask, Medium 60737 ResMed Hospital NV Full Face Mask, Large 60711 Headgear (10 pk.) 4 ResMed Hospital Mask ( ) ResMed ^^¡í^SMttSSí S®ftSK^£o ResMed ifflÄfflnTLÖ^^Äffi^iaS: • Д^±^Й;ЙЁП|Ш¥КЛШЙФ, • fflil^±^SÏ#t№KtMÆlttrôÆ^À ( sa 30 Äff ) о • föffli^-^Л, Si^f7 ^о А »^амщ • ^SÀâS^^ITffi...