Penlon ESO 2 User manual

ESO 2 IU Ventlator  User Manual
Important
Servicing and Repairs
In order to ensure the full operatonal lfe of ths ventlator,
servcng by an engneer traned by the manufacturer should
be undertaken perodcally
The ventlator must be servced to the followng schedule
1 Sx monthly servce - nspecton and functon testng
2 Annual / two year / four year servce - nspecton and
functon testng, and component replacement
Detals of these operatons are gven n the Servce Manual
for ths ventlator, avalable only for engneers traned by the
manufacturer
For any enqury regardng the servcng or repar of ths
product, contact Penlon Ltd
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 (refer to the devce ID label)
4 Approxmate date of purchase
5 Apparent fault

ESO 2 IU Ventlator  User Manual
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 ESO 2
Emergency Ventlator
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 ts 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’s functon before usng the
apparatus
The Importance of Patient Monitoring
WARNIN
Patent montors are very desrable ads 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
Foreword

ESO 2 IU Ventlator  User Manual
Contents
Servicing and Repairs ...............................................................................i
The Importance of Patient Monitoring.................................................................ii
1. Warnings and Cautions ......................................................................... 2
2. Purpose ...................................................................................... 5
3. Description ................................................................................... 6
3.1 ESO 2 System Description ...................................................................6
3.2 Ventilator .................................................................................7
3.3 Spirometry ...............................................................................19
3.4 Display Waveforms ........................................................................20
3.5 Alarms ..................................................................................21
3.6 Oxygen Monitor ...........................................................................22
4. Pre-operation Checks and Procedures ............................................................ 25
4.1 Ventilator Set-up ..........................................................................25
4.2 Pre-use Checklist .........................................................................30
4.3 Oxygen Monitor System Set-up ..............................................................32
5. Start-up and operating instructions .......................................................... 34
5.1 Pre-use checks and components.............................................................34
5.2 Start-up .................................................................................34
5.3 Suggested Protocol for closed endotracheal suction in Volume or Pressure Mode: .......................35
5.4 Oxygen monitor ...........................................................................36
6. Maintenance 37
6.1 Service Schedule ..........................................................................37
6.2 Cleaning and Disinfection...................................................................37
6.3 Sterilisation ..............................................................................39
6.4 Oxygen Sensor Replacement ................................................................40
6.5 Electrical Interface, Cables, Tubing...........................................................41
6.6 Bellows Assembly - Removal and Cleaning ....................................................41
6.7 Sterilisation and Disinfectant Treatment Table .................................................42
7. Appendix ..................................................................................... 43
APPENDIX 1 Care of Back-up Battery ...................................................................43
APPENDIX 2 Disposal at end of useful life - risk assessment ..............................................43
APPENDIX 3 Optional extras and approved accessories ....................................................43
APPENDIX 4 Operating system......................................................................44
APPENDIX 5 Spontaneous Mode and Patient Support Modes ............................................50
APPENDIX 6 Specification ................................................................................55
Application ...............................................................................55
Internal Compliance .......................................................................55
Physical .................................................................................55
Alarms ..................................................................................55
Functional................................................................................56
Advanced Spontaneous Breathing Modes (SIMV, SMMV, PSV)......................................57

ESO 2 IU Ventlator v User Manual
Contents
Page No
Disinfection and Sterilisation ................................................................57
Bacterial Filter............................................................................57
Fail Safe Mechanism.......................................................................57
Reliability ................................................................................57
Waveform Tests ...........................................................................57
Volume Tests .............................................................................57
Mobility and Mounting......................................................................57
Device Classification and Labelling ...........................................................58
Oxygen Monitor ...........................................................................59
APPENDIX 7 On-screen Menus .....................................................................60
APPENDIX 8 Symbols .............................................................................62
APPENDIX 9 References ..............................................................................63
APPENDIX 10. Electromagnetic compatibility (EMC) ....................................................63

ESO 2 IU Ventlator 1 User Manual
User Responsibility
Ths ventlator 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 Ltd
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 the
manufacturer and must not be altered or modfed n any way
wthout the wrtten approval of the manufacturer 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 the
manufacturer
USA and anada 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
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 the user 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
Always take partcular notce of the warnngs, cautons and
notes provded throughout ths manual

ESO 2 IU Ventlator 2 User Manual
1. Warnings and Cautions
The followng WARNINS and AUTIONS must be read and
understood before usng ths ventlator
WARNINS
Important
Delverng hgh fresh gas flows
1 Hgh fresh gas flows when usng closed endotracheal
sucton Ths ventlator s confgured to delver flows of
oxygen n excess of the maxmum shown on the flowmeter
tube n order to fll the ventlator bellows durng closed
endotracheal sucton Up to approxmately 30 L/mn can be
delvered
Delverng O flows n excess of the maxmum calbrated
flow wll temporarly negate the possblty of accurate
volume delvery and measurement Once the ventlator
bellows s full the O flow should be reduced to that n range
of the calbrated flow tube, then accurate volume delvery
and measurement wll resume
See secton 53 for addtonal nformaton
eneral Informaton
2 Users must make themselves famlar wth the contents
of ths manual and the machne’s functon before usng
the ventlator
Before Usng the Ventlator
3 Before the ventlator s used clncally for the frst tme a
albraton heck and Output heck must be successfully
completed hecks must be carred out by a Penlon-
traned engneer
4 onnect the ventlator to a mans supply wth a protectve
earth Before frst clncal use, verfy that the hosptal
engneerng department has carred out an earth
contnuty test If the ntegrty of the protectve conductor
s n doubt, do not use the ventlator
5 Excessve electronc nose caused by other poorly
regulated devces, such as an electrocautery unt, may
adversely nterfere the functonng of the ventlator
Do not connect the ventlator’s power cord nto the same
electrcal outlet as an electrocautery unt
6 If used wth a mans extenson cord, the unt may be
subect to electro-magnetc nterference
7 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 the ventlator, ncludng cables
specfed by the manufacturer Otherwse, degradaton of
the performance of ths equpment could result
8 The drvng gas supply must be clean and dry to prevent
ventlator malfuncton
9 Ths ventlator s desgned to be drven by medcal ar
only The drve gas s set durng manufacture and the
ventlator s calbrated for that gas
Before the ventlator s used clncally for the frst tme,
the commssonng engneer must confrm that the ar/
oxygen selecton s set correctly to Ar
The use of any other gas wll cause naccurate operaton
and may damage the ventlator, resultng n potental
nury to the patent
10 The drvng gas s dscharged through the exhaust
valve port at the back of the ventlator control unt
The dscharged gas may contamnate the envronment
onnect to an ASS system f avalable
11 The bellows can only support approxmately 1 kPa
(10cmHO) dfferental postve pressure, above whch
t may be dslodged from the mountng rng, resultng n
dangerous malfuncton of the ventlator Do not connect
a postve end expratory pressure (PEEP) valve or other
restrctve devce to the exhaust port on the bellows base
Ths would ncrease the pressure nsde the bellows and
the bellows could detach from the base, causng serous
malfuncton
12 The data output, VA, and prnter ports must only be
connected to equpment complyng wth IE safety
standards (eg IE 60950) whch are then confgured to
comply wth IE 60601-1 (Medcal Systems)
13 Breathng System
The breathng system whch conveys gases from the
ventlator to the patent, and dsposes of expred gases,
must conform to the requrements of ISO80601-2-13
Because breathng systems requre frequent cleanng
and dsnfecton they are not a permanent part of the
ventlator and therefore cannot be drectly under the
control of the manufacturer However, we strongly
recommend that only breathng systems whch have been
approved and authorsed by the manufacturer for use
wth the ventlator should be employed
14 Do not use conductve breathng system hoses
15 The sprometer sensors are mounted wthn the
absorber Do not ft a sprometer sensor to any other
locaton The devce wll not measure exhaled volumes n
any other poston
16 Verfy the operaton of each alarm functon daly
Perodcally check the alarms at clncally sutable
ntervals If the audble alarm or the vsual ndcator
of any alarm functon fals to actvate durng any alarm
condton or fals to reset after the alarm has been
cleared, refer the unt to an authorsed servce engneer
17 Before usng the ventlator check that all hose
connectons are correct, and verfy that there are no
leaks Patent crcut dsconnects are a hazard to the
patent Extreme care should be taken to prevent such
occurrences
Usng the Ventlator
18 Do not use Spontaneous (SPONT) mode
19 Before each clncal procedure, carry out pre-use
functon checks on the ventlator (see secton 4213)
20 Ths apparatus must not be used wth, or n close
proxmty to, flammable anaesthetc agents
There s a possble fre or exploson hazard

ESO 2 IU Ventlator 3 User Manual
Warnings and Cautions
21 Do not use the ventlator n an oxygen-rch envronment
22 Mans power supply solaton Dsconnect the mans
supply cable from the socket at the back of the ventlator
control unt (see 32) or at the mans power outlet
23 When the ventlator s connected to a patent, t
s recommended that a qualfed practtoner s n
attendance at all tmes to react to an alarm or other
ndcaton of a problem
24 An alternatve means of ventlaton must be avalable
whenever the ventlator s n use
25 It s recommended that the patent oxygen concentraton
should be montored contnuously
26 If the drve gas supply pressure drops below a nomnal
241 kPa (35 ps), the LOW DRIVE AS SUPPLY alarm wll
actvate both audbly and vsually Patent mnute volume
may be reduced due to lowered flow rates
27 An audble alarm ndcates an anomalous condton and
should never go unheeded
28 The characterstcs of the breathng crcut connected
between the ventlator and the patent can modfy or
change patent ventlaton To assst n the mantenance
of the delvered patent tdal volume, the ventlator
control system software ncludes
a) a complance compensaton algorthm,
b) a fresh gas compensaton algorthm
However, patent ventlaton must be montored
ndependently from the ventlator
It s the responsblty of the user to montor patent
ventlaton
29 heck that the flow sensors are connected correctly to
the nspratory and expratory ports of the breathng
module
30 The Vent Inop (ventlator noperatve) alarm ndcates that
one of the followng condtons has occurred
a) The drve gas solenod has faled
b) The flow control valve has faled
c) Internal electronc fault
d) Internal electrcal fault
e) Software error
31 Note that f a ventlator error s detected, ‘Ventlator
Inoperatve’ wll be dsplayed on the front control panel
dsplay
32 The Hgh and Low arway pressure alarms are mportant
for patent care It s mportant that the sensor s properly
located n the expratory lmb of the crcut - refer to
secton 418
33 The patent must be contnuously attended and
montored, even when advanced breathng modes are n
use
34 Do not touch any electrcal devce cable or connector at
the same tme as the patent
User Mantenance
35 User mantenance s restrcted to cleanng the
outsde surfaces of the ventlator, see secton 6 Other
procedures detaled n ths manual must be carred out
by traned engneers
Servce and repar operatons must only be carred out by
an engneer traned by the manufacturer
The warranty for ths product s vod f the product s
not mantaned n accordance wth the servce schedule
detaled n secton 61, and the procedures publshed n
the Servce Manual for ths product
36 The ventlator must not be modfed or dsassembled by
any unauthorsed person
ontrol Unt
37 Openng the control unt by unauthorsed personnel
automatcally vods all warrantes and specfcatons
Preventon of tamperng wth the control unt s
exclusvely the user’s responsblty If the control unt
seal s broken, the manufacturer assumes no lablty for
any malfuncton or falure of the ventlator
38 For contnued protecton aganst fre hazards, any
replacement fuses must be the dentcal type and
ratng as the orgnal components Replacement must be
carred out by a traned engneer
See secton 4 for fuse ratng
39 If the nternal battery s fully dscharged, the ventlator
wll not functon n the event of mans power falure The
battery must be recharged before the ventlator s used
clncally, otherwse backup cannot be guaranteed
See Appendx 1 for battery mantenance See auton 6
Used or defectve batteres must be dsposed of
accordng to hosptal, local, state, and federal
regulatons
40 No ol, grease or other flammable lubrcant or sealant
must be used on any part of the ventlator 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
41 Exteror panels must not be removed by unauthorsed
personnel and the apparatus must not be operated wth
such panels mssng There s a possble electrc shock
hazard
42 The ventlator has ppelne-only gas supply connectons
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
Bellows Assembly
43 The valve seat on the patent gas exhalaton daphragm
valve n the base of the bellows assembly must be
cleaned regularly 
Falure to keep the valve seat clean could result n the
daphragm stckng, thus preventng exhalaton
reat care must be taken not to damage the precson
surface of the valve seat on the patent gas exhalaton
daphragm valve n the base of the bellows assembly
Never use any hard obect or abrasve detergent to clean

ESO 2 IU Ventlator 4 User Manual
Warnings and Cautions
the valve seat use only a soft cloth
If the valve seat s damaged, the valve wll leak and may
cause serous ventlator malfuncton
AUTIONS
1 Do not sterlse the ventlator control unt
Internal components (apart from the patent block
assembly) are not compatble wth sterlsaton
technques and damage may result
The patent block assembly must be removed from the
control unt before sterlsaton (see secton 627)
After cleanng and sterlsaton, the patent block
assembly must be reftted to the orgnal control unt
Refer to secton 6275
2 For ventlator components whch requre sterlsaton,
peak sterlsaton temperatures should not exceed 134o
(275oF) to prevent possble damage (See secton 6)
3 are must be taken not to let any lqud run nto the
control unt serous damage may result
4 The exhalaton valve located n the bellows base
assembly and the paedatrc bellows adaptor must be
cleaned and sterlsed separately Note that the bellows
assembly s bult nto the Breathng module
5 Always check for correct ftment, and carry out a full
functon test (4213 ) before clncal use, f the bellows
has been removed and reftted for any reason 
6 Damage wll occur to the battery f t s allowed to reman
n a dscharged state heck the battery frequently f the
ventlator s n storage (see Appendx 1)
7 Fresh gas compensaton s dsabled f
a) The sprometry system s turned OFF through the
menu system, or
b) The sprometry system s not functonng correctly
8 Fresh gas mxture compensaton s dsabled f
a) The sprometry system s turned OFF through the
menu system, or the sprometry system s not
functonng correctly
b) The oxygen montor s swtched OFF
Refer to secton 417
9 rcut complance s not actvated untl Fresh as
ompensaton s swtched OFF Refer to secton 32
OXYEN MONITOR
WARNINS
1 We recommend a calbraton check of the oxygen
montor every tme the system s turned on, as a safety
precauton
2 Do not attempt to open the fuel cell
The sensor contans small quanttes of electrolyte,
classfed as a harmful rrtant whch s potentally
hazardous, and lead
Used or defectve cells must be dsposed of accordng to
hosptal, local, state, and federal regulatons
3 ALWAYS check the ntegrty of the sensor assembly
before use
4 Once exhausted, the sensor must be dsposed of
accordng to hosptal, local, state and federal regulatons
5 The sensor measures oxygen partal pressure, and ts
output wll rse and fall due to pressure change
An ncrease n pressure of 10% at the sensor nlet wll
produce a 10% ncrease n sensor output
6 The oxygen sensor s not sutable for sterlsaton
If contamnaton s suspected, ft a new sensor (see
secton 64) and dspose of the contamnated unt
accordng to hosptal, local, state and federal regulatons
AUTIONS
1 Do not sterlse any oxygen montor component
2 Do not autoclave or expose the sensor to hgh
temperatures
3 If the sensor shows sgns of beng affected by
condensaton, dry the sensor wth soft tssue
Do not use heat to dry the sensor
NOTES
1 The O SENSOR FAULT alarm ndcates that one of the
followng condtons has occurred
a) Internal electrcal fault
b) Software/electroncs fault
c) Oxygen sensor fault
2 The concentraton read-out may, n certan condtons of
excess pressure, show a value above 100%
To accommodate these condtons t s possble to set the
hgh alarm value up to 105% (see secton 5)
3 To mantan maxmum sensor lfe
a) Always swtch off the gas delvery swtch after use, to
ensure that the basal flow ceases
b) Dsconnect the breathng crcut after use
4 The accuracy of flow and volume measurements may be
reduced f the oxygen montor s not n use
5 Fresh gas mxture compensaton s dsabled f the oxygen
montor s swtched ‘off’ n the menu