Ultra Mirage™ Non-vented full face mask Clinical Guide English
A Mask Parts / Teile der Maske / Composants du masque / Parti della maschera / Piezas de la mascarilla / Peças da máscara / Maskeronderdelen Forehead support pad / Stirnpolster / Tampon du support frontal / Imbottitura del supporto frontale / Almohadilla del apoyo para la frente / Almofada do suporte da testa / Kussentje van voorhoofdsteun Ultra Mirage TM NON-VENTED FULL FACE MASK Illustrations Sheet / Illustrationsblatt / Fiche d'Illustrations / Fogolio delle Illustrazioni / Forehead support / Stirnb
B B-1 Fitting the Mask / Anlegen der Maske / Mise en place du masque / Come indossare la maschera / Colocación de la mascarilla / Colocação da máscara / Het masker opzetten Forehead support tab / Stirnbauteillasche / languette du support frontal / Linguetta del supporto frontale / Lengüeta del apoyo para la frente / Dispositivo de fixação do suporte da testa / Tab van de voorhoofdsteun C C-1 B-2 Disassembling for Cleaning / Demontage zu Reinigungszwecken / Démontage pour le nettoyage / Smontaggio per l
D Reassembling the Mask / Wiederzusammenbau der Maske / Remontage du masque / Riassemblaggio della maschera / Montaje de la mascarilla / Montagem da máscara / Het masker opnieuw monteren D-1 Luer lock ports cap / Anschlusskappen für Luer-Verbindungsstück / Bouchon(s) d'entrée de raccord Luer / Tappi porte con connessione Luer / Tapas de puerto Luer lock / Tampas das portas com fecho do tipo Luer / Poortkap(pen) met luer-vergrendeling D-2 Mask port / Anschlussöffnung / Port(s) du masque / Porta della ma
English 608323.book Page 1 Tuesday, December 6, 2011 9:40 AM Ultra Mirage™ NON-VENTED FULL FACE MASK The Ultra Mirage NV (non-vented) Full Face Mask is a non-invasive device used for channelling air flow with or without supplemental oxygen. Intended Use The Ultra Mirage NV Full Face Mask is intended to be used with active-exhaustvalve ventilator systems, to provide ventilatory assistance to patients with respiratory insufficiency and respiratory failure.
08323.book Page 2 Tuesday, December 6, 2011 9:40 AM the ventilator enclosure. 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. • Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition. If symptoms occur, consult your physician or dentist. About the Mask The mask system does not contain latex, PVC or DEHP materials.
5 Gently tighten the lower headgear straps (B-4). The pads of the forehead support should sit comfortably on the forehead when the mask is in place. If the pads are at an angle and not completely seated on the forehead, change the position of the forehead support tab. Note: Do not overtighten the headgear straps as this may cause discomfort, cushion creases and mask leak. The Ultra Mirage NV Full Face Mask has been designed to provide a comfortable seal without the need to overtighten the headgear.
608323.book Page 4 Tuesday, December 6, 2011 9:40 AM Simply pull the Emergency Release Cord and the two part clip separates, allowing you to remove the mask from the face. Figure 1: Emergency Release Cord. Note: The Emergency Release Cord should only be used to remove the mask in the event of an emergency. Overuse of the Emergency Release Cord may result in the deterioration of the two part clip mechanism. Disassembling for Cleaning See section C on the illustrations sheet.
Cleaning the Mask in the Home Notes: • Wash your hands before cleaning the mask. • It is important to always handwash the headgear. • The headgear may be washed without being disassembled from the headgear clips. Daily/After each use Handwash the mask components in warm (approximately 30ºC) water for one minute using mild soap or detergent. Rinse the components well with drinking quality water and allow them to air dry out of direct sunlight.
608323.book Page 6 Tuesday, December 6, 2011 9:40 AM 3 To attach the elbow retainer, fit one side of the elbow retainer against the groove of the elbow. While holding one wing of the elbow retainer down (D-3a), press the other wing down until it clicks into place (D-3b). 4 Rotate the elbow retainer to its original position (D-4). 5 Check that you have fitted the elbow and elbow retainer correctly by firmly pulling the elbow away from the frame.
Pressure (cm H2O) Maximum Leak (L/min) 4–20 6 English 608323.book Page 7 Tuesday, December 6, 2011 9:40 AM 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 260 mL. Standards CE designation in accordance with EC directive 93/42/EEC, class IIa. 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.
608323.book Page 8 Tuesday, December 6, 2011 9:40 AM Temperature limitation Does not contain natural rubber latex Manufacturer Clinical Guide 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 Part No.
Part No. Item 60124 Forehead pad (10 pk.) 60675 Mask Frame, Small (1 pk.) 60676 Mask Frame, Medium (1 pk.) 60677 Mask Frame, Large (1 pk.) 60673 Forehead Support (1 pk.) 60917 Headgear (1 pk.) English 608323.book Page 9 Tuesday, December 6, 2011 9:40 AM 60618 Emergency Release Cord assembly (1 pk.) 60619 Emergency Release Cord assembly (10 pk.) Europe 1 - English, German, French, Italian, Spanish, Portuguese, Dutch.
Manufacturer: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia Distributed by: ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA ResMed (UK) Ltd 96 Milton Park Abingdon Oxfordshire OX14 4RY UK See www.resmed.com for other ResMed locations worldwide. For patent information, see www.resmed.com/ip Ultra Mirage and Mirage are trademarks of ResMed Ltd and Mirage is registered in the U.S. Patent and Trademark Office. CIDEX and STERRAD are trademarks of Johnson & Johnson.
608323/1 2011-12 Ultra Mirage NVFFM CLINICAL EUR 1 - ENG 608323 Global leaders in sleep and respiratory medicine www.resmed.