8/6/2019 CARTA VIASYS.

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VelaVentilator

ECRI Response

VENTILATION

August10,

2006

ToOurValu

edCustome

rs:

Ithascome

toouratte

ntionthat

someofou

rcompetito

rsmaybep

resentinga

nincomplet

epic-

tureoft

heVelaV

entilatorba

sedonare

centECRIe

valuationo

ftheventil

ator.

IntheinitialECRIE

valuationo

fIntensive

CareVenti

lators,VEL

Areceived

anunaccep

tableratin

g

becauseof

thedefaultHigh

PeakPress

ureAlarms

ettingof75

cmH2O.T

hisisaUse

rSelectable

AlarmSetti

ngthatsho

uldbeevaluated

bytheuse

randseta

ppropriately

beforeap

plyingthev

enti-

latortoap

atient.

VELAcom

plieswith

alllocalandna

tionalreg

ulatorybo

diesinall1

00countrie

sthatitiss

old.Thisin

-

cludesthe

USFDA.Th

edefaultv

alueof75cmH2Oh

asbeenpr

esentonV

ELAsincei

tsreleasein

2002.

VIASYShas

notreceiv

edanyrep

ortsregard

ingpatientinjuryd

uetothisd

efaultvalue

.Wehave

always

askedusers

toplease

ensuretha

ttheychec

ktheirAlar

mSettingsScreen

beforeatt

achingthe

ventila-

tortoapat

ientandse

ttheiralar

mvaluesa

ppropriatel

y.

InMay200

6VIASYSR

espiratoryC

arerelease

dasoftwar

eupgrade

forVELAto

changethedefaul

tHigh

PeakPress

ureAlarmv

aluefrom7

5to40cmH

2O.Thisso

ftwareisa

vailablefor

fieldinstal

lationupon

customerr

equest.Al

lnewVELA

Comprehe

nsiveventi

latorsshipp

edfromou

rfactorysi

nceMayha

vehad

thissoftwa

reinstalled

.

PleasenotetheEx

cellentand

Goodratin

gsthatVEL

Areceived

inthissam

eECRIeval

uationfor

Easeof

Use,Reliabi

lity,QualityofC

onstruction

andMonito

ring.Wear

eproudof

theVELAa

ndtheunit

sinthe

fieldworkin

geveryda

ytosupportlife

.

Thankyouf

oryoursup

portofVIAS

YSHealthca

resproducts.

DanielVanH

ise

VicePreside

ntofMark

eting

ECRI,inth

esameInte

nsiveCare

VentilatorEvalua

tion,alsoh

adthe

followingco

mmentsab

outVELA

Performa

nce:Goo

d

EaseofU

se: Excel

lent

Monitori

ngandCom

munication

s: Good

Qualityof

Constructi

on: Good

Reliability

: Good

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nited States:2745 Savi Ranch Parkwayorba Linda, CA 92887.S.A.oll-Free: (800) 231-2466hone: +1 (714) 283-2228ax: +1 (714) 283-8493

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

Asia:1605B Sino Plaza255-257 Gloucester RoadCauseway Bay, Hong KongPhone: +(852) 2891 8026Fax: +(852) 2893 6939

C061406 Rev A

www.viasyshealthcare.com

ECRI has upgraded the status of VELA toAcceptable. 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 wasnot pending FDA approval

Monitoring &Communications ratedGood

User Interface

ratedExcellent

for ease of

use

Performance

Quality of

Construction Reliability

all rated Good

Alarm Default Settingsmodified to 40 cmH2OHigh PPEAK

ACCEPTABLE

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

ECRI welcomes any inquires into their evalua-tion of the VELA product line. For direct com-

munications with ECRI please contact:

Patrice HughesProject Engineer Health Devices Group

Phone: +1 (610) 825-6000 extension 5546phughes@ecri.org