Penlon Prima 460 - Purpose

Prma 460 7 User Manual
2. Purpose
Intended Use
The Prma 460 s ntended for use by a traned, professonal,
clncal operator n a professonal healthcare envronment, and
must be contnually attended when n use
The Prma 460 s ntended to provde controlled concentratons
and flows of anaesthesa gases nto a patent breathng
system, from where the anaesthesa ventlator and breathng
crcut wll then delver ths fresh gas mxture to the patent
Use the Prma 460 n conuncton wth anaesthetc vaporzers,
breathng hoses and patent connecton fttngs whch comply
wth the relevant ISO standard or equvalent
Dependng upon the patent crcut selected, the Prma 460
can be used n open, sem-open, sem-closed or closed crcut
confguratons
Intended patent populaton
The Prma 460 s ntended to be used for a patent populaton
from neonatal to adult
Intended part of the body or type of tssue appled to or
nteracted wth
No drect nteracton wth any part of the human body
ontrandcatons
The Prma 460 s not sutable for use n an MRI envronment
Envronment
The Prma 460 s sutable for use n a professonal healthcare
faclty
Do not use the Prma 460 near HF surgcal equpment,
or outsde the RF shelded room of a medcal system for
magnetc resonance magng where the ntensty of EM
dsturbances s hgh
Indcatons for use of the Prma 460
User and patent profles
The Prma 460 s ntended for use by traned, professonal,
clncal operators
The Prma 460 s ntended to provde contnuous mechancal
ventlatory support durng anaesthesa The Prma 460 s a
restrcted medcal devce ntended for use by qualfed traned
personnel under the drecton of a physcan
Specfcally the Prma 460 s applcable for adult, paedatrc,
and neonatal patents
The Prma 460 s not applcable for patents n ntensve care
applcatons
Sub-assembles
The absorber s used to transmt ventlated gas to and from a
patent whlst absorbng O n the patent expred gas
The mechancal AHD system s desgned to mnmse the rsk
of a hypoxc mxture reachng the patent
The Oxygen Montor s ntended to contnuously measure and
dsplay the concentraton of oxygen n breathng gas mxtures
used n anaesthesa, and s ntended for adult, paedatrc, and
neonatal patents The oxygen montor s an ntegral part of
the Prma 460
onfguratons
The Prma 460 has been desgned to gve a wde choce of
confguratons and accessores, ncludng
as supples
Three gases - oxygen, ntrous oxde, and ar
Pn-ndex cylnder yokes, and provson for up to three ppelne
supply nlets
Vaporzer mountng systems
Backbar manfold for Selectatec ompatble type vaporzers