Penlon Prima 320 Advance User manual

Prima 320 Advance Anaesthetic Machine User Manual
ANAESTHESIA SOLUTIONSANAESTHESIA SOLUTIONS

Prma 320 Advance  User Manual
IMPORTANT
Servcng and Repars
In order to ensure the full operatonal lfe of ths devce,
servcng by an engneer traned by the manufacturer should
be undertaken perodcally
The machne must be servced to the schedule detaled n
secton 71
Detals of these operatons are n the Prma 320 Advance
servce manual, whch contans servcng procedures etc
Servcng should be carred out by engneers traned by Penlon
Ltd
For any enqury regardng the servcng or repar of ths devce,
contact the nearest accredted Penlon agent
or communcate drectly wth
UK and ROW, except USA
Techncal Support
Penlon Lmted
Abngdon Scence Park
Abngdon, OX14 3NB, UK
Tel [phone]
Fax [phone]
E-mal techsupportpenloncom
Always gve as much of the followng nformaton as possble
1 Type of equpment
2 Product name
3 Seral number
4 Approxmate date of purchase
5 Apparent fault
NOTE
The seral number can be found on the devce ID label

Prma 320 Advance  User Manual
IMPORTANE OF PATIENT MONITORIN
WARNIN
Anaesthesa systems have the capablty to delver mxtures
of gases and vapours to the patent whch could cause nury
or death unless controlled by a qualfed anaesthetst
There can be consderable varaton n the effect of
anaesthetc drugs on ndvdual patents so that the settng
and observaton of control levels on the anaesthesa system
does not n tself ensure total patent safety
Anaesthesa system montors and patent montors are very
desrable ads for the anaesthetst but are not true clncal
montors as the condton of the patent s also dependent
on hs respraton and the functonng of hs cardo-vascular
system
IT IS ESSENTIAL THAT THESE ELEMENTS ARE MONITORED
FREQUENTLY AND REULARLY AND THAT ANY
OBSERVATIONS ARE IVEN PREEDENE OVER MAHINE
ONTROL PARAMETERS IN JUDIN THE STATE OF A
LINIAL PROEDURE
Before usng any montorng system or devce, the user must
check that t conforms to the relevant standards
Ths manual has been produced to provde authorsed
personnel wth nformaton on the functon, routne,
performance and mantenance checks applcable to the Prma
320 Advance anaesthetc machne
Informaton contaned n ths manual s correct at the date of
publcaton The polcy of the manufacturer s one of contnued
mprovement to ther products Because of ths polcy the
manufacturer reserves the rght to make any changes whch
may affect nstructons n ths manual, wthout gvng pror
notce
Personnel must make themselves famlar wth the contents
of ths manual and the machne functon before usng the
apparatus
Foreword

Prma 320 Advance  User Manual
Page
1. Warnings and Cautions ................................................................................ 2
2. Purpose............................................................................................. 4
3. Description .......................................................................................... 5
3.1 General Construction.................................................................................. 5
3.2 Gas Circuit ..........................................................................................5
3.3 Front View ...........................................................................................7
3.4 Rear View ...........................................................................................7
3.5 Communication Port ..................................................................................7
3.6 Control Panel ........................................................................................8
3.7 Electrical Power Supply................................................................................ 9
3.8 Vaporizers ..........................................................................................11
3.9 Absorber ...........................................................................................12
3.10 Auxiliary Common Gas Outlet (ACGO) and O Flush control.................................................. 14
3.11 Anaesthetic Gas Scavenge System (AGSS) ...............................................................14
3.12 Ventilator........................................................................................... 15
3.13 Patient monitoring - Parameters .................................................................16
3.14 Alarm system .......................................................................................17
4. Specification........................................................................................ 18
4.1 Physical............................................................................................18
4.2 Gas Supplies........................................................................................ 18
4.3 Gas Supply Pressure .................................................................................19
4.4 Flowmeter Tubes ....................................................................................19
4.5 Auxiliary Oxygen Supply...............................................................................19
4.6 Auxiliary Common Gas Outlet (ACGO) ...................................................................19
4.7 Oxygen Flush .......................................................................................19
4.8 Fresh Gas Mixture ...................................................................................19
4.9 Environmental ......................................................................................19
4.10 Electrical Supply.....................................................................................20
4.11 Absorber and Breathing System .......................................................................20
4.12 Ventilator........................................................................................... 21
4.13 Monitored Parameters................................................................................21
4.14 Alarm Settings ......................................................................................22
4.15 Device Classification and Labelling .....................................................................23
5. Installation and Pre-Use Checks ....................................................................... 24
5.1 Installation and commissioning before first clinical use .................................................... 24
5.2 Absorber Assembly ..................................................................................25
5.3 Connecting Gas Monitoring Modules ....................................................................27
5.4 Installing the Vaporizer ............................................................................... 28
5.5 Gas cylinder installation ..............................................................................28
5.6 Medical Gas Pipeline Connection .......................................................................29
5.7 Auxiliary Power Outlets ...............................................................................29
5.8 Anaesthetic Gas Scavenging System (AGSS) .............................................................29
5.9 Pre-use Test before each clinical procedure..............................................................30
5.10 Vaporizer Tests ......................................................................................34
5.11 Alarm System Tests ..................................................................................35
5.12 Breathing System Test................................................................................38
Contents

Prma 320 Advance v User Manual
Contents
5.13 Oxygen Flush Test ...................................................................................39
5.14 Pre-use Procedure...................................................................................39
6. Operating the Anaesthesia System ..................................................................... 41
6.1 Basic Operations and Settings ......................................................................... 41
6.2 Display Controls .....................................................................................44
6.3 Fresh Gas Settings...................................................................................49
6.4 Ventilation Mode..................................................................................... 50
6.5 Monitoring Parameters ...............................................................................60
6.6 Pulmonary Function..................................................................................60
6.7 Alarm Setup ........................................................................................61
6.8 Trends .............................................................................................61
6.9 Replace Absorbent...................................................................................62
6.10 Auxiliary Common Gas Outlet (ACGO) ...................................................................63
6.11 Alarms.............................................................................................63
7. Maintenance........................................................................................ 67
7.1 User Maintenance ................................................................................... 67
7.2 Cleaning and Disinfection .............................................................................68
7.3 Absorber and Breathing System Components ............................................................70
7.4 Cleaning and Disinfection Methods .....................................................................75
7.5 Absorber and breathing system ........................................................................ 77
7.6 Pressure Sensor Zeroing..............................................................................78
7.7 Flow Sensor Zeroing .................................................................................78
7.8 Oxygen Concentration Calibration ...................................................................... 79
7.9 Touchscreen Calibration ..............................................................................80
7.10 Prevention of Water Build-up .......................................................................... 80
7.11 Battery Replacement .................................................................................80
7.12 Fault Diagnosis and Troubleshooting....................................................................81
8. Appendix ................................................................................................ 82
Appendix 1 References....................................................................................... 82
Appendix 2 Disposal at end of useful life: Risk assessment......................................................... 82
Appendix 3 Optional extras and approved accessories .............................................................82
Appendix 4 Labelling ........................................................................................ 83
Appendix 5 Sidestream CO module (optional)....................................................................85
Appendix 6. Electromagnetic compatibility (EMC).................................................................87

Prma 320 Advance 1 User Manual
Ths devce has been bult to conform wth the specfcaton
and operatng procedures stated n ths manual and/or
accompanyng labels and notces when checked, assembled,
operated, mantaned and servced n accordance wth these
nstructons
To ensure the safety of ths devce t must be checked and
servced to at least the mnmum standards lad out n ths
manual A defectve, or suspected defectve, product must not
under any crcumstances be used
The user must accept responsblty for any malfuncton whch
results from non-complance wth the servcng requrements
detaled n ths manual
Addtonally, the user must accept responsblty for any
malfuncton whch may result from msuse of any knd,
or non-complance wth other requrements detaled n
ths manual
Worn, broken, dstorted, contamnated or mssng components
must be replaced mmedately Should such a repar become
necessary t s recommended that a request for servce advce
be made to Penlon Lmted or the nearest Penlon Servce
entre
Ths devce and any of ts consttuent parts must be repared
only n accordance wth wrtten nstructons ssued by
Penlon Lmted and must not be altered or modfed n any
way wthout the wrtten approval of Penlon Lmted
The user of ths equpment shall have the sole responsblty
for any malfuncton whch results from mproper use,
mantenance, repar, damage or alteraton by anyone other
than Penlon Lmted or ts apponted agents
USA and anadan Federal Law restrcts the sale and use of
ths devce to, or on the order or, a lcensed practtoner
User Responsibility
Statements n ths manual preceded by the followng words
are of specal sgnfcance-
WARNIN
means there s a possblty of nury to yourself or others
AUTION
means there s a possblty of damage to the apparatus
or other property
NOTE
ndcates ponts of partcular nterest for more effcent
and convenent operaton
The reader must take partcular notce of the warnngs,
cautons and notes provded throughout ths manual

Prma 320 Advance 2 User Manual
The followng WARNINS and AUTIONS must be read and
understood before usng ths machne
WARNINS
1 Ths anaesthetc machne system s desgned for use only
wth non-flammable anaesthetc agents It must not be
used wth or n close proxmty to flammable anaesthetc
agents, due to a possble fre or exploson hazard
2 Exteror panels must not be removed by unauthorsed
personnel and the machne must not be operated wth
such panels mssng Unauthorsed personnel must not
attempt to access fuses or other electrcal components
There s a possble electrc shock hazard
3 To solate the machne from the mans power supply,
dsconnect the mans cable from the hosptal power
outlet
4 Always use a mans power outlet socket that can be easly
accessed
5 No ol, grease or other flammable lubrcant or sealant
must be used on any part of the machne n close
proxmty to medcal gas dstrbuton components
There s a rsk of fre or exploson
6 When you attach or remove a medcal gas cylnder
a) Follow approprate manual handlng gudelnes when
lftng
b) Ensure that the machne yoke and cylnder faces
are dust free and clean and that the sealng washer
provded s n poston between the cylnder valve and
the yoke
c) Tghten the yoke securely before openng the cylnder
valve Dust and drt presents a fre hazard n the
presence of hgh pressure gas Leakage of hgh
pressure gas can cause serous nury
7 The machne must be connected to an anaesthetc gas
scavengng system (ASS) to dspose of waste gas and
prevent possble health hazards to operatng room staff
Ths requrement must be observed durng test
procedures as well as durng use wth a patent
8 Ths devce must only be used wth Selectatec-compatble
vaporzers nstalled on the Selectatec-type backbar
system
Free-standng vaporzers may be accdentally tpped,
resultng n excessve and uncalbrated volumes of
anaesthetc drug enterng the breathng system
9 Do not nstall or connect any vaporzers of any descrpton
between the auxlary common gas outlet (AO) and the
breathng system unless they are specfcally desgned for
such use
(If ths s done, the oxygen flush flow wll pass through the
vaporzer and may result n gross overdosage when the
flush valve s operated)
10 Ventlatng Neonatal and Paedatrc patents
a) IMPORTANT
Use ONLY Volume ontrol or Pressure ontrol
ventlaton for mandatory ventlaton of neonates
b) IMPORTANT
Swtchng ventlaton modes durng a clncal procedure
 The ventlator wll automatcally revert to the
settngs that were last used n the mode that you are
about to use
 To protect the neonatal/paedatrc patent from adult
ventlaton settngs, always swtch to Standby before
swtchng ventlaton modes
Set approprate neonatal/paedatrc parameter
values for the mode that you are about to use, before
recommencng ventlaton
c) Always set a low target pressure frst and then ncrease
to the requred level
d) Use breathng crcuts and flters specfcally desgned
for neonatal/paedatrc use
e) Do not ventlate pre-term babes wth a brth weght
below 24 kg
11 Only vaporzers wth the Selectatec-compatble nterlock
functon wll nterlock f nstalled on a two staton or three
staton manfold
The nstallaton of non-nterlock vaporzers allows the
possble operaton of more than one vaporzer at the
same tme
12 The breathng system whch conveys gases from the
anaesthesa system to the patent and dsposes of
expred gases s a vtal part of the anaesthetc delvery
system Because breathng systems requre frequent
cleanng and dsnfecton they are not a permanent
part of the anaesthesa system and therefore cannot be
drectly under the control of the anaesthetc machne
manufacturer When mechancal ventlaton s employed
the patent breathng system must be connected drectly
to an over-pressure relef valve to prevent the possblty
of barotrauma
13 Always perform a pre-use check of the system, ncludng
vaporzers, ventlator, absorber and montors before
clncal use Follow the pre-use checklsts (see sectons
59 to 514) before each clncal procedure as a mnmum
requrement
Many clncal ncdents occur because of a falure to check
for correct functon
14 The anaesthesa system must not be used f any of the
alarm, montorng or protecton system devces are not
functonng correctly
15 The gas supply falure systems wthn the anaesthesa
system wll not necessarly operate as ndcated n ths
manual durng any procedures that are outsde the scope
of the ndcatons for use of the machne
1. Warnings and Cautions

Prma 320 Advance 3 User Manual
Do not use the system solely to provde large flows of
oxygen, va the auxlary gas outlets, to external devces
whch may not be equpped wth a supply falure alarm
16 The system must not be ftted wth more than three
operator accessble mans socket outlets There s a
rsk of an excessve leakage current Ths can result n a
reduced level of safety
17 Be aware that when equpment s connected to an
auxlary outlet, a medcal electrcal system s created as
defned n IE 60601-1-1 (Refer to auton 8)
18 On machnes wth ppelne connectons, be aware that a
malfuncton of the central gas supply wthn your faclty
may cause mmedate cessaton of gas delvery and total
anaesthesa system falure
19 The use of antstatc or electrcally conductve breathng
hoses s not recommended when usng hgh frequency
electrcal surgery equpment (eg Dathermy) Burns
may be caused
To avod the rsk of electrc shock, ths system must only
be connected to a mans supply wth a protectve earth
Before any electrcally powered machne s used clncally
for the frst tme, check that the hosptal engneerng
department has carred out an earth contnuty test
20 Before usng any addtonal electrcal equpment powered
by the auxlary sockets on the machne, a traned
engneer must check that the addtonal equpment s
correctly wred and s earthed through ts plug
In the event of malfuncton of any devce powered by the
auxlary sockets, a traned engneer must check the
devce and machne fuses
21 A mssng or defectve protectve earth conductor may
ncrease earth leakage currents to the patent to values
exceedng the allowable lmts, resultng n ventrcular
fbrllaton, or nterference wth the pumpng acton of the
heart
22 Portable RF communcatons equpment (ncludng
perpherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12
nches) to any part of ths devce, ncludng cables
specfed by the manufacturer Otherwse, degradaton of
the performance of ths equpment could result
23 Addtonal equpment placed on the top shelf must be
securely attached
Take care when movng a fully loaded machne,
partcularly when negotatng ramps
heck that hoses or power leads are not tralng on the
floor
24 Accessores must be removed before the machne s
transported
25 MRI compatblty - The Prma 320 Advance s not MRI
compatble
26 To prevent patent nury n the event of total anaesthesa
system falure, an alternatve means of ventlaton must
be avalable whenever the devce s n use
27 The Apnea alarm s a vsual, onscreen alarm (no audo
functon), and s actve only n SPONT/PSV mode
28 User mantenance
User Mantenance s restrcted to cleanng the external
surfaces of the machne (see Secton 72)
All other mantenance and servcng and the replacement
of components, ncludng fuses and the mans electrcal
cable, must be carred out only by Penlon-traned
engneers
AUTIONS
1 Flowmeter needle valves are desgned to seal wth lght
torque and may be damaged f tghtened excessvely
Do not force the control knob past ether the fully open or
fully closed postons
2 Open cylnder valves slowly to avod damage to pressure
reducng valves
Ensure that cylnder valves are at least one full turn open
when n use
3 Do not use anaesthetc agents for cleanng purposes
4 After use, always dsconnect the machne from the pped
gas supply and/or close the gas cylnder valves
5 Ant-hypoxc devce (AHD) system - The oxygen flow
control s restrcted to prevent the needle valve from fully
closng Ths ensures a mnmum basal flow of oxygen
DO NOT attempt to close the flow to zero
Do not overtghten
6 ompressed gas supples must be clean and dry
7 When the auxlary gas outlets are n use on a machne
usng cylnder supply only (e If the ppelne supply s not
n use), check flow rate requrements, and ensure that
adequate back-up cylnders are avalable
8 The requrements of IE 60601-1-1 apply to any devce
connected to the auxlary electrcal sockets Users must
be aware of the rsks of ncreased leakage currents when
equpment s connected to the auxlary power sockets
9 Do not apply excessve pressure to the dsplay screens
10 onnect the external OMMS outlet only to approved
devces usng protocol provded by Penlon Ltd ontact
Techncal Support Department for detals
11 Vaporzers Read the nstructon manual suppled wth
the vaporzer before clncal use
NOTE
1 Refer to Appendx 3 for labellng and symbols
Warnings and Cautions

Prma 320 Advance 4 User Manual
Purpose
The Prma 320 Advance anaesthetc machne s for use by a
professonal operator n a professonal hosptal or clncal
envronment, and must be contnually attended when n use
The devce 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 devce 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 machne can
be used n open, sem-open, sem-closed or closed crcut
confguratons
Intended patient population
This product is intended for a patient population from neonatal
(infants) to adult.
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
Backbar manfold for Selectatec-compatble type vaporzers
Ant-Hypoxc Devce (AHD)
The AHD system s desgned to mnmse the rsk of a hypoxc
mxture reachng the patent
2. Purpose