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WARNINGS:

•  Please read the entire guide before use.
•  Remove all packaging before using the mask.
•  Ensure mask vent holes are clear from obstruction.
•  CPAP systems are intended to be used with special masks with connectors which have 

vent holes to allow continuous flow of air out of the mask. When the CPAP machine is 

turned on and functioning properly, new air from the CPAP machine flushes the exhaled air 

out through the attached mask exhalation port. However, when the CPAP machine is not 

operating, enough fresh air will not be provided through the mask, and exhaled air will 

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 systems.

•  At low CPAP pressures the flow through the exhaled port may be inadequate to clear all 

exhaled air from the tube. Some rebreathing may occur.

•  To minimize the risk of vomiting during sleep, the patient should avoid eating or drinking 

for three hours before using the mask. This mask is not recommended if the patient is 

taking a prescription drug that may cause vomiting.

•  Do not use the mask without the Non-Rebreathing Valve in place.
•  This mask should not be used on patients who are uncooperative, obtunded, unresponsive, 

or unable to remove the mask.

•  Follow all precautions when using supplemental oxygen.
•  Oxygen flow must be turned off when the flow generator is not operating, so that unused 

oxygen does not accumulate within the flow generator enclosure and create a risk of fire.

•  At a fixed flow rate of supplemental oxygen, the inhaled oxygen concentration varies, 

depending on the pressure settings, patient breathing pattern, mask, point of application 

and leak rate.

•  The technical specifications of the mask are provided for your clinician to ensure 

compatibility with the flow generator. If it is used beyond technical specifications or 

used with incompatible devices, the seal and comfort of the mask may not be effective, 

optimum therapy may not be achieved, and leak, or variation in the rate of leak, may 

affect the function of the flow generator.

•  Stop using the mask and consult your physician or sleep therapist, if you have ANY adverse 

reaction to the use of the mask.

•  Refer to your flow generator manual for details on settings and operational information.
•  As with all masks, some rebreathing may occur at low CPAP pressures.

Summary of Contents for Sol CM205

Page 1: ...ion Manual Sol Full Face CPAP Mask CM205 Manufactured for Sunset Healthcare Solutions 180 N Michigan Ave Ste 2000 Chicago IL 60601 United States IFU 00047 REV 1 01 2022 02 23 EN English ES Espa ol FR...

Page 2: ...hould also be given when it must be used In either case it is up to the doctor to decide whether or not to use the mask These complications include Recent eye surgery or dry eyes Glaucoma Hiatal herni...

Page 3: ...rug that may cause vomiting Do not use the mask without the Non Rebreathing Valve in place This mask should not be used on patients who are uncooperative obtunded unresponsive or unable to remove the...

Page 4: ...Parts of the mask Forehead support Elbow Swivel Vent Cushion Frame assembly Headgear Clip Upper headgear straps Lower headgear straps Frame...

Page 5: ...Fitting Use a standard conical connector if pressure readings and or supplemental oxygen are required Continued on next page 1 3 2 4...

Page 6: ...tabs on the upper headgear straps Pull the straps evenly until they are comfortable and firm and reattach the Velcro Ensure that the mask fits well Undo the fastening tabs on the lower headgear strap...

Page 7: ...s Fit the cushion into the channel of the frame Gently separate the cushion from the frame Thread the upper headgear straps through the loop of the frame and secure Clip the headgear to the lower part...

Page 8: ...ask components in direct sunlight as it may accelerate product aging Do not iron the headgear It may damage the headgear If cleaning is not done in accordance with the instructions or if cleaning freq...

Page 9: ...laced Problem Possible cause Solution Mask is too noisy Vents are blocked or partially blocked Mask is assembled incorrectly Clean vents according to Instructions in Cleaning the Mask at Home Reassemb...

Page 10: ...30 cmH2 O Resistance Drop in Pressure measured at 50 L min 0 5 cmH2 O at 100 L min 1 5 cmH2 O Inspiratory and expiratory resistance with the Non Rebreathing Valve open to atmosphere pressure Inspirat...

Page 11: ...5 C to 40 C Operating humidity 10 90 relative humidity non condensing Storage and transport 4 F to 140 F 20 C to 60 C Storage and transport humidity 10 90 relative humidity non condensing Note The ma...

Page 12: ...pecial measures for the safe and effective use of the device Unique device identifier It is warranted that the Mask including Frame assembly Cushion Headgear shall be free from defects in material and...

Page 13: ...Manual de instrucciones Sol Mascarilla facial completa para CPAP CM205 ES Espa ol...

Page 14: ...restarse especial atenci n cuando se la debe usar En cualquier caso es responsabilidad del m dico decidir si usar o no la mascarilla Estas complicaciones incluyen Cirug a ocular reciente o sequedad en...

Page 15: ...edicamento recetado que puede causar v mitos No use la mascarilla si no tiene colocada la v lvula antirreinhalaci n Esta mascarilla no debe usarse en pacientes que no colaboran que est n obnubilados o...

Page 16: ...tes de la mascarilla Soporte para la frente Codo Conector giratorio Orificios de ventilaci n Amortiguador Conjunto del marco Arn s Presilla Correas superiores del arn s Correas inferiores del arn s Ma...

Page 17: ...Colocaci n Use un conector c nico est ndar si es necesario medir la presi n o administrar ox geno complementario Contin a en la p gina siguiente 1 3 2 4...

Page 18: ...riores del arn s Tire de las correas de manera pareja hasta que las sienta c modas y firmes y vuelva a cerrar el Velcro Compruebe que la mascarilla quede bien colocada Abra las leng etas de ajuste de...

Page 19: ...iores del arn s Encastre el amortiguador en el canal del marco Separe el amortiguador del marco con suavidad Pase las correas superiores del arn s por el gancho del marco y suj telas Abroche el arn s...

Page 20: ...se puede acelerar el desgaste del producto No planche el arn s Se puede da ar Si la limpieza no se realiza de acuerdo con las instrucciones o si se aumenta la frecuencia de limpieza puede ocasionar q...

Page 21: ...os de ventilaci n est n total o parcialmente bloqueados La mascarilla est mal ensamblada Limpie los orificios de ventilaci n seg n las instrucciones de Limpieza de la mascarilla en el hogar Vuelva a e...

Page 22: ...H2 O Resistencia Ca da en la presi n medida a 50 l min 0 5 cm H2 O a 100 l min 1 5 cm H2 O Resistencia inspiratoria y espiratoria con la v lvula antirreinhalaci n abierta a la presi n atmosf rica Insp...

Page 23: ...edad de funcionamiento del 10 al 90 de humedad relativa sin condensaci n Almacenamiento y transporte de 20 C a 60 C de 4 F a 140 F Humedad de almacenamiento y transporte del 10 al 90 de humedad relati...

Page 24: ...para el uso seguro y eficaz del dispositivo Identificador nico del dispositivo Se garantiza que la mascarilla que incluye el conjunto del marco el amortiguador y el arn s no tendr defectos de materia...

Page 25: ...Manuel d instructions Sol Masque facial complet pour CPAP CM205 FR Fran ais...

Page 26: ...particuli re devrait tre apport e lors de son utilisation Dans les deux cas il revient au m decin de d cider s il est possible ou non d utiliser le masque Ces complications comprennent Chirurgie ocula...

Page 27: ...sque sans la valve sans r inspiration maintenue en place Ce masque ne doit pas tre utilis chez les patients qui ne coop rent pas qui ont une perte de sensibilit qui ne r pondent pas ou qui ne peuvent...

Page 28: ...Pi ces du masque Soutien frontal Coude Pivot Orifice d a ration Coussinet Ensemble de cadre Harnais Pince Courroies sup rieures du harnais Courroies inf rieures du harnais Cadre...

Page 29: ...Ajustement Utilisez un connecteur conique standard si les lectures de pression et ou l oxyg ne d appoint sont requis Suite la page suivante 1 3 2 4...

Page 30: ...ur les courroies de mani re uniforme jusqu ce qu elles soient confortablement et solidement ajust es et rattachez la bande Velcro Assurez vous que le masque est bien ajust D tachez les attaches de fix...

Page 31: ...le coussinet dans le canal du cadre Retirez d licatement le coussinet du harnais Ins rez les courroies sup rieures du harnais dans la boucle du cadre et verrouillez le tout Attachez le harnais la part...

Page 32: ...lumi re directe du soleil car cela pourrait acc l rer le vieillissement du produit Ne pas repasser le harnais Cela pourrait endommager le harnais Si le nettoyage n est pas effectu conform ment aux in...

Page 33: ...on sont obstru es ou partiellement obstru es Le masque n a pas bien t assembl Nettoyez les orifices d a ration conform ment aux instructions dans la section Nettoyez le masque votre domicile R assembl...

Page 34: ...istance Baisse de pression mesur e 50 L min 0 5 cmH2 O 100 L min 1 5 cmH2 O R sistance inspiratoire et expiratoire avec la pression ouverte l atmosph re de la valve sans r inspiration R sistance inspi...

Page 35: ...C 41 F 104 F Humidit de fonctionnement 10 90 d humidit relative sans condensation Entreposage et transport Entre 20 C 60 C 4 F 140 F Entreposage et transport 10 90 d humidit relative sans condensation...

Page 36: ...arantir une utilisation s re et efficace de l appareil Identification unique de l appareil Il est garanti que le masque y compris l ensemble de cadre le coussinet et le harnais seront exempts de d fau...

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