Read letter.indd text version

Vela® Ventilator

ECRI Response

plete incom pican g ting ratin resen ilator. table able ep 06 ay b he vent unaccep lect , 20 st 10 entiors m Se n ft Augu petit uation o ceived a s a User ing the v om rc re val ers: his i re apply of ou VELA CRI e O. T stom some recent E tilators, 75 cmH2 tely befo d Cu lue hat n pria ur Va g of ion t on a e Ve To O ttent r based sive Car rm settin set appro d the ur a ilato o ha ten ure Ala oo nd et ra ent ion of In ress n, als e use s com a® V It ha f the Vel I Evaluat h Peak P ted by th uatio l R o a ig r Eva ture initial EC efault H be evalu ilato d e In th se of the at should Vent cau g th Care n be Setti sive nt. A Alarm o a patie Inten out VEL e t ab lator sam

V E N T I L AT I O N

he nts ood I, in t comme ood ECR wing G lent ns: G e: tio his in follo rformanc : Excel mmunica od ld. T 002. is so in 2 · Pe se of Use and Co tion: Go at it e ies th its releas e always tr · Ea nitoring onstruc av coun since h all 100 . We entil LA · Mo ality of CGood s in a nt on VE ult value ing the v die y bo rese defa tach · Qu liability: lator s been p e to this efore at egu nal r H2O ha njury du Screen b High · Re i m ault s natio

c f g nt e de l and ettin of 75 patie ge th tion upon had l loca ult value garding r Alarm S an al to ch with efa have talla s re thei tely. plies A. The d y report y check VELA r field ins nce May ia for com S FD opr n i e da ppr ade ilable fo ry s t th VELA the U ceive upgr ues a e tha facto a des as not re se ensur larm val ware are is av rom our clu of a soft oftw f plea Ease YS h heir ed a s ped VIAS users to nd set t n for in the eleas 2O. This tors ship atio a re r d ntila cmH evalu units ry Ca aske a patient irato 75 to 40 ensive ve ECRI and the e r to esp om to reh YS R ue fr is sam he VELA omp l in th VIAS LA C ved roud of t 006 Alarm va VE cei ay 2 LA re re p In M ressure t. All new s P at VE ing. We a s th itor eak er reque lled. P ing m on sta d rat custo ftware in Goo on and M and ructi o ent this s s. onst xcell e. duct the E ality of C pport lif 's pro ote , Qu en care o su Pleas eliability ry day t ealth YS H R ve IAS Use, orking e t of V ppor eld w fi r su r you ou fo ky Than e ng nHis rketi f Ma iel Va nt o Dan eside ce Pr Vi

ECRI has upgraded the status of VELA to "Acceptable". This upgrade in status was published in their latest Ventilator Evaluation. They also addressed the fact that the software upgrade was done voluntarily by VIASYS and was not pending FDA approval

Monitoring & Communications rated Good User Interface rated Excellent for ease of use

· Performance · Quality of Construction · Reliability all rated Good

ACCEPTABLE reclassification printed in Health Devices, June 2006, Volume 35, Number 6

ECRI welcomes any inquires into their evaluation of the VELA product line. For direct communications with ECRI please contact:

Alarm Default Settings modified to 40 cmH2O High PPEAK

Patrice Hughes

Project Engineer Health Devices Group Phone: +1 (610) 825-6000 extension 5546 [email protected]

United States: 22745 Savi Ranch Parkway Yorba Linda, CA 92887 U.S.A. Toll-Free: (800) 231-2466 Phone: +1 (714) 283-2228 Fax: +1 (714) 283-8493

RC061406 Rev A

Europe: Leibnizstrasse 7 D-97204 Hoechberg Germany Phone: +49 (0) 931 4972 - 0 Fax: +49 (0) 931 4972 - 423

Asia: 1605B Sino Plaza 255-257 Gloucester Road Causeway Bay, Hong Kong Phone: +(852) 2891 8026 Fax: +(852) 2893 6939

www.viasyshealthcare.com

Information

letter.indd

2 pages

Find more like this

Report File (DMCA)

Our content is added by our users. We aim to remove reported files within 1 working day. Please use this link to notify us:

Report this file as copyright or inappropriate

31496