NeoMedLight BiliCocoon Instructions For Use Manual Download Page 1

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Instructions for use:

BiliCocoon™ Fixation System

IFU-BCC301-EnFr-2017-04-v03 Page 1

EN/FR

BiliCocoon™ Fixation

System

Summary of Contents for BiliCocoon

Page 1: ...Instructions for use BiliCocoon Fixation System IFU BCC301 EnFr 2017 04 v03 Page 1 EN FR BiliCocoon Fixation System...

Page 2: ...Device 5 C Additional information 5 2 Safety information 5 3 Technical specifications 7 4 Installation and method for use 9 A Preliminary precautions 9 B Installing the fixation system 10 5 Maintenanc...

Page 3: ...if 16 C Informations suppl mentaires 16 2 Informations de s curit 17 3 Caract ristiques techniques 18 4 Installation et mode d emploi 20 A Pr cautions pr alables 20 B Mise en place du syst me de fixat...

Page 4: ...this case NeoMedLight recommends you dispose of the device and replace it The user will be considered solely responsible for the risks incurred by the patient caregivers third parties or goods or if...

Page 5: ...onTM Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates and infants under 3 months old and weighing less than 10kg It can be used in the...

Page 6: ...indicated or for medical indications or parts of the body for which it is not recommended or authorised This could either render the system completely ineffective no treatment benefits or could put th...

Page 7: ...PECIFICATIONS The fixation system or BiliCocoon Fixation System is a fixation system designed for exclusive use with the BiliCocoon System a medical device offering a treatment solution for unconjugat...

Page 8: ...System Please ensure that the product is stored and used in accordance with the recommended conditions Warning No not alter the BiliCocoon Fixation System Do not use any accessories spare parts and eq...

Page 9: ...that there are no missing screws Check that the mobile hinge can be tightened without any obstruction Warning Check that the holding claw is not damaged nor chipped Warning Also check that the two fix...

Page 10: ...ion System is designed for exclusive use with the BiliCocoon System a medical device offering a treatment solution for unconjugated hyperbilirubinemia in new born babies using phototherapy Warning Whi...

Page 11: ...ir hand Presentation of the fixation system Hanging the fixation system The fixation system consists of a fixation plate 1 with two fixation hooks as well as a holding claw 2 Completely unscrew the sc...

Page 12: ...Cocoon Fixation System groove Once the fixation system is properly attached to the stand hang the BiliCocoon Light Box 4 by resting the Light Box unit handle on the two fixation hooks Everything must...

Page 13: ...tant agents used in paragraph 5 A then carefully rinse with a soft wet cloth Perform a visual inspection of the BiliCocoon Fixation System to assure that it is clean Otherwise repeat the previous inst...

Page 14: ...BiliCocoon Fixation System if its integrity and or its functions are compromised by a defect or worn parts 7 PRODUCT REFERENCE BCC010 BiliCocoon Light Box BCC101 BiliCocoon Nest System BCC111 BiliCoco...

Page 15: ...commande de le mettre au rebut et de le remplacer L utilisateur sera consid r comme seul responsable des risques encourus par le patient le personnel soignant les tiers ou les biens ou si les performa...

Page 16: ...hyperbilirubin mie non conjugu e4 chez la population des nouveau n s terme et pr matur s Ag s de moins de trois mois et pesant moins de 10 kg d finition selon la EN 60601 2 50 Il peut tre utilis en en...

Page 17: ...de celles pr conis es n est pas autoris e En effet cela pourrait conduire soit un syst me totalement inefficace aucun b n fice th rapeutique soit une situation potentiellement risque pour la sant eff...

Page 18: ...ixation system est un dispositif de fixation destin tre utilis exclusivement avec le BiliCocoon System dispositif m dical apportant une solution de traitement par phototh rapie l hyperbilirubin mie no...

Page 19: ...rtissement Aucune modification du Bilicocoon Fixation system n est permise Ne pas utiliser aucun accessoire pi ce d tach e et mat riel non d crit dans les conditions d utilisations L usage du syst me...

Page 20: ...soit ni abim e ni br ch e Avertissement V rifier galement que les deux crochets de fixations soient en bon tat et ne soient ni abim s ni br ch s Avertissement Le syst me de fixation est appel tre att...

Page 21: ...f m dical apportant une solution de traitement par phototh rapie l hyperbilirubin mie non conjugu e du nouveau n Avertissement Tant que Bilicocoon fixation system est utilis pour accrocher BiliCocoon...

Page 22: ...ge du syst me de fixation Le syst me de fixation est compos d une plaque de fixation 1 comportant des crochets de fixations ainsi que d une pince de fixation vis dite Holding Clow 2 Veuillez d visser...

Page 23: ...n Fixation System Une fois que le syst me de fixation est bien solidaire du support veuillez pendre la BiliCocoon Light Box 4 en faisant reposer la poign du boitier Light Box sur les deux crochets de...

Page 24: ...nfectants autoris s paragraphe 5a puis rincer soigneusement avec un chiffon doux et humide Effectuer une inspection visuelle du BiliCocoon Fixation System afin d assurer qu il est propre Dans le cas c...

Page 25: ...le BiliCocoon Fixation system lorsque son int grit et ou sa fonctionnalit est compromise par un d faut ou une usure 7 R F RENCE PRODUITS BCC010 BiliCocoon Light Box BCC101 BiliCocoon Nest System BCC1...