Penlon Prima 465 User manual

User Manual
ANAESTHESIA SOLUTIONS
Prima 465 Anaesthetic Machine

Prma 465 Anaesthetc Machne  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
Detals of these servce operatons are gven n the Prma 465
servce manual, avalable only for Penlon-traned engneers
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
USA
Penlon Inc
11515 K-Tel Drve
Mnnetonka
MN 55434
USA
Toll Free 800-328-6216
Tel 952-933-3940
Fax 952-933-3375
E-mal customerservce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 (refer to the devce ID label)
4 Approxmate date of purchase
5 Apparent fault

Prma 465 Anaesthetc Machne  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
465 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 465 Anaesthetc Machne  User Manual
Contents
1. Warnings and Cautions ................................................................................ 2
2. Purpose............................................................................................. 5
3. Description .......................................................................................... 6
3.1 General construction ..................................................................................6
3.2 Gas circuit ...........................................................................................6
3.3 Gas supply safety devices ..............................................................................7
3.4 Gas circuit components and controls.....................................................................8
3.5 Vaporizer...........................................................................................11
3.6 Communications ports ...............................................................................11
3.7 Control panel .......................................................................................12
3.8 Electrical Power Supply............................................................................... 13
3.9 Alarm system ....................................................................................... 15
3.10 Absorber ...........................................................................................16
3.11 Anaesthetic gas scavenge system (AGSS) ................................................................17
3.12 Ventilator........................................................................................... 18
3.13 Patient monitoring ..................................................................................19
4. Specification........................................................................................ 20
4.1 Physical dimensions .................................................................................20
4.2 Gas supplies ........................................................................................20
4.3 Gas supply pressure and flow rate ......................................................................21
4.4 Auxiliary gas outlets..................................................................................21
4.5 Oxygen flush ........................................................................................21
4.6 Fresh gas mixture ................................................................................... 21
4.7 Environmental ......................................................................................22
4.8 Electrical supply.....................................................................................22
4.9 Ventilator and breathing system........................................................................23
4.10 Device classification and labelling ......................................................................26
5. Installation and Pre-use Checks ....................................................................... 27
5.1 Installation and Commissioning before first clinical use .................................................... 27
5.2 Pre-use test before each clinical procedure ..............................................................33
5.3 Visual Inspection .................................................................................... 33
5.4 Start up test ........................................................................................34
5.5 Pipeline gas supply tests.............................................................................. 36
5.6 Oxygen fresh gas supply check ......................................................................... 37
5.7 Cylinder gas supplies................................................................................. 37
5.8 Vaporizers .........................................................................................39
5.9 Alarm tests .........................................................................................40
5.10 Breathing circuit tests ................................................................................42
5.11 Oxygen flush test ....................................................................................43
5.12 Preoperative procedure ...............................................................................43
6. Operating the Anaesthesia System ..................................................................... 44
6.1 Ventilation modes....................................................................................44
6.2 Standby mode.......................................................................................51
6.3 Home screen .......................................................................................52
6.4 Function fields ...................................................................................... 53
6.5 Ventilator setting fields ............................................................................... 60
6.6 Fresh gas fields .....................................................................................60

Prma 465 Anaesthetc Machne v User Manual
6.7 Waveform field displays...............................................................................61
6.8 Measured values fields - key parameters ................................................................63
6.9 Measured values fields - general parameters ............................................................ 63
6.10 Anaesthetic Gas fields (optional) .......................................................................63
6.11 Alarm silence status .................................................................................63
6.12 Alarm message field .................................................................................64
6.13 System prompt message and icons field ................................................................. 69
6.14 System start-up procedure ............................................................................69
6.15 Ventilation mode.....................................................................................70
6.16 Monitoring parameters ...............................................................................71
6.17 Absorber ..........................................................................................72
6.18 System shut-down procedure ..........................................................................73
7. Maintenance........................................................................................ 74
7.1 Service schedule ....................................................................................74
7.2 Cleaning and dsnfect
i on ......................................................................75
7.3 Absorber and breathing system ........................................................................ 76
7.4 Anaesthetic gas scavenging system - Receiver unit ........................................................81
7.5 Breathing system sensors.............................................................................81
7.5 Flowmeter zero calibration procedure................................................................... 81
7.7 Oxygen monitor calibration ............................................................................82
7.8 Water trap - sidestream anaesthetic gas monitoring module (optional) ....................................... 84
7.9 Battery replacement ................................................................................. 84
7.10 Fault diagnosis and troubleshooting .................................................................... 84
8. Appendix ........................................................................................... 86
Appendix 1. References ...................................................................................... 86
Appendix 2. Disposal at end of useful life: risk assessment ........................................................86
Appendix 3. Optional extras and accessories ....................................................................86
Appendix 4. Labelling ........................................................................................ 87
Appendix 5. Gas circuit.......................................................................................90
Appendix 6. Optional sidestream anaesthetic gas monitoring module - single agent ...................................91
Appendix 7. Electromagnetic compatibility (EMC).................................................................98
Contents

Prma 465 Anaesthetc Machne 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 of, 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
Ind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 465 Anaesthetc Machne 2 User Manual
1. Warnings and Cautions
The following WARNINGS and CAUTIONS must be read and
understood before using this anaesthesia system.
Warnngs
1 Ths anaesthesa 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 anaesthesa system 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
Always use a mans power outlet socket that can be
easly accessed
4 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
5 Attachng or removng a medcal gas cylnder
a) Follow approprate manual handlng gudelnes
when lftng
b) heck 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
6 The anaesthesa system 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
7 Ths machne must only be used wth Selectatec-
compatble vaporzers nstalled on the backbar
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
8 Only vaporzers wth the Selectatec-compatble nterlock
functon wll nterlock f nstalled on the backbar
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
9 The breathng system whch conveys gases from the
anaesthetc machne 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
they are not a permanent part of the anaesthetc
machne 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
10 Always perform a pre-use check of the machne,
ncludng vaporzers, ventlator, absorber and montors
before clncal use Follow the pre-use checklst (see
secton 52) 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
11 The system start-up test (secton 54) ncludes an
automatc system test Ths test ncludes system
calbraton tests If the screen dsplays a ‘Fal’ for the
Pressure sensor, Flow sensor, or Flowmeter zero
calbraton tests, follow the nstructons gven n
sectons 751, 752, and 76
DO NOT use any other procedures
If a ‘Fal’ error s stll dsplayed, contact a Penlon-traned
servce engneer
12 The machne must not be used f any of the alarm,
montorng, or protecton system devces are not
functonng correctly
13 Auxlary gas outlets Flow rates greater than 60 L/mn
could affect the fresh gas flow to the patent
14 When the auxlary gas outlets are n use on a machne
usng cylnder supply only (e f the ppelne supply s
not n use), check flow rate requrements, and check that
adequate back-up cylnders are avalable
15 Do not use the machne solely to provde large flows of
oxygen, va the anaesthetc machne auxlary outlets,
to external devces whch may not be equpped wth a
supply falure alarm
16 On machnes wth ppelne connectons only, note 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
17 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
18 Before usng any addtonal electrcal equpment
powered by the auxlary sockets on the machne, check
that the addtonal equpment s correctly wred and s
earthed through ts plug
19 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

Prma 465 Anaesthetc Machne 3 User Manual
20 Portable RF (rado frequency) 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
21 Addtonal equpment placed on the top shelf must be
securely attached
22 The followng condtons must apply before the machne
s transported
a) Detachable parts removed
b) The drawers must be empty
c) All gas cylnders must be removed
23 MRI compatblty - Prma 465 models are not MRI
compatble
24 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
25 Obstructon of the breathng system can restrct or
stop gas flow to the patent, and can cause nury or
death Make sure that there are no obstructons n the
breathng system
26 Keep very small components/parts/plugs away from the
breathng system
27 Use non-conductve breathng system hoses
28 Do not touch any electrcal devce connector at the same
tme as the patent, when the machne s connected to
the mans supply
29 Ths machne s not sutable for use n oxygen-rch
envronment
30 Ths devce must not be altered or modfed n any way
wthout the wrtten permsson of Penlon lmted
31 Make sure that the absorber canster sensor s clean and
unobstructed by cables or tubng etc, at all tmes
32 ommuncaton ports should not be subected to
voltages greater than 7 V D Damage to nternal
crcutry may occur
33 In the event of a mans falure or operaton of the mans
crcut breaker, the auxlary mans outlet sockets wll
not functon Make sure that any equpment connected to
the auxlary mans outlet sockets are protected aganst
mans falure
Warnings and Cautions
34 Ventlatng neonates (nfants)
a) Use only Pressure ontrol Ventlaton or Volume
ontrol ventlaton for mandatory ventlaton of
neonates
b) Always set a low target pressure frst and then
ncrease to the requred level
c) Use breathng crcuts and flters specfcally desgned
for paedatrc/neonatal use
d) Do not ventlate pre-term babes wth brth weghts
below 24 kg
35 Patent montorng
a) Always use an anaesthetc agent montor that
comples wth the latest relevant standard
b) Always montor oxygen concentratons
c) Always check that the montors are functonng
correctly before startng the clncal procedure
d) An external anaesthetc gas montorng devce,
complyng wth ISO/IE 80601-2-55 must be
connected to the breathng crcut Use the
manufacturer’s nstructons to correctly connect the
devce
36 When connectng other equpment to the auxlary sockets a
medcal electrcal system s created and the whole system
should be re-evaluated to the requrements of BS EN
60601-1
37 as analyser (NO, O, O) measurements are ntended
only to assst n patent assessment These devces must
be used n conuncton wth other patent physologcal
ndcatons and n the assessment of the overall patent
condton
38 When any accessory s nstalled on the shelf or attached
to an arm mount, you must check the stablty of the
anaesthetc machne before use
39 When the machne s n operaton, the alarm message
feld must be vsble to the operator at all tmes
40 Sdestream anaesthetc gas montorng module (f
ftted) heck the water trap for damage (cracks, etc) and
replace f damaged
To mantan adequate levels of hygene, the water trap must
be replaced every four weeks
Note that the sample tubng s a sngle-use component

Prma 465 Anaesthetc Machne 4 User Manual
Warnings and Cautions
autons
1. Open cylinder valves slowly to avoid damage to
pressure reducing valves.
Check that cylinder valves are at least one full turn
open when in use.
2. Under no circumstances should anaesthetic agents be
used for cleaning purposes.
3. After use, always disconnect the machine from the
piped gas supply and/or close the gas cylinder valves.
4. Compressed gas supplies must be clean and dry.
5. The requirements of IEC 60601-1 apply to any device
connected to the auxiliary electrical sockets. Users
must be aware of the risks of increased leakage
currents when equipment is connected to the auxiliary
power sockets
6. In the event of malfunction of any device powered by
the auxiliary sockets, check if the circuit breaker has
tripped.
7. Do not apply excessive pressure to the display screens.
8. Connect the external RS232 outlet only to approved
devices using protocol provided by Penlon Ltd. Contact
Technical Support Department for details.
9. Vaporizers: Read the instruction manual supplied with
the vaporizer before clinical use.
Note
1 Screen dsplays and waveform dsplays shown n ths
manual are gven as examples only
Settngs and the parameter values shown may not be
replcated on your system
2 Refer to Appendx 4 for labellng and symbols