Copyright © 6/11 All Rights Reserved
Analytical Industries Inc. dba Advanced Instruments Inc.,
2855 Metropolitan, Pomona, CA 91767 USA.
Tel: 909-392-6900, Fax: 909-392-3665
Email: sales-industrial@aii1.com, Web: www.aii1.com
This manual may not be reproduced in whole or in part without
the prior written consent of Analytical Industries Inc.
Table of Contents
1 Introduction 1
1.1 Indications for Use
1.2 Intended Use
1.3 Device Description
1.4 Declaration of Conformity
2 Quality Control Certification 5
3 Safety Warnings 6
4 Start-up 8
4.1 Contents of Shipping Container
4.2 Controls
4.3 Start-Up Test
4.4 Calibration
4.5 Mounting
5 Operation 12
5.1 Principle of Operation
5.2 Application Considerations
5.3 Calibration
5.4 Sampling
6 Maintenance 17
6.1 Service ability
6.2 Battery Replacement
6.3 Oxygen Sensor Replacement
6.4 Reassembly
6.5 Remote Oxygen Sensor Replacement
7 Troubleshooting 21
8 Specifications 22
8.1 Spare Parts & Optional Accessories 23
9 Warranty 24
10 Material Safety Data Sheet (MSDS) 25
10.1 Disposal 25
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1 Introduction
Congratul a tions o n your p urch ase, t hese Ins tr ucti ons fo r U se des cri be th e pr ecautions, set-up, operation, maintenance and specifications of the AII-2000
Palm O2 Oxygen Analyzer.
This symbol means CAUTION – Failure to read and comply with the
Instructions for Use could damage the device and possibly jeopardize
the well being of the patient and/or health care professional.
Note: Analytical Industries Inc. cannot warrant any damage resulting from the
misuse, unauthorized repair or impr oper maintenance of the dev ice.
1.1 Indications for Use
The AII- 2000 Palm O2 Oxygen A nalyzer is intende d to meas ure and display the
concentr atio n o f ox yg en i n breat hi ng g as m ixtur es . Th e int en ded us e i s onl y to
verify, spot check or contin uously mo nitor, oxyge n concentr ations in circumstances w her e t he o xy gen con centr ati on is co ntr oll ed an d s et by ot her me dical
device such as oxygen/air blenders, flow meters or other control device.
Users m ust read th e followi ng statements as they are es sential to reducing the r is k of us e erro r du e to ergo nomi c f eat ur es of th e devi ce o r
the environment in which the device is intended to be used.
The de vices as ide ntified i n Section 1 .4 Declar ation of Co nformity have been
designed and man uf actured i n s u ch a way that when used u nder the co ndi ti ons
and for the purposes intended, they will not compromise the clinical condition
or the safety of patients, or safety of the users or other persons.
Federal law restric t s this device to sale by or on the order of a physicia n.
Conform ity wi th ess enti al re quir eme nts has been demo nstr ate d by ver if ying th e
performance of the device under normal conditions, bench testing, pre-clinical
and simulated clinical evaluations and determining that undesirable malfunctions constitute minimal risk to patients and users.
Particular requirements for sterilization do not apply to these devices. Do not
sterilize, autoclave, liquid sterilize, immerse in any liquid or expose the device
or acce ss o r ies to steam, ethy lene oxide or radiation ste r ilization.
i
1
The device is i ntended to be re-usabl e. S ho ul d t h e device o r access or i es co m e
in contact w ith p atien t bo dil y fl uids , eit her di spos e o f th e devi c e or clea n wi th
a soft cloth dampened with 70% isopropyl alcohol solution in water and allow
the components to air-dry before re-use .
The device and accessories are not intended to transport or store any medicines, bo dy l iquids or ot her s ubstan ces th at ca n be adminis tered or rem oved
from the body, and, do not contain any latex, human blood derivatives, phthalates, carcinogens or other reproductive toxics.
Calibrate the device with 100 % o xygen b efore using each da y or aft er 8 hours
of continuous use. In the event the device fails to calibrate or if the reading
becomes, do not attempt to use the device. Contact the manufacturer for
assistance.
Do not operate the analyzer near eq uipment c a p abl e of emi t ting hig h levels of
electromagnetic radiation as the reading may become unstable.
In order to obt ain op ti mum p erforman ce, t he o peration of th e d evice m ust b e
performed in accordance with th ese Instructions for Us e. Maintenan ce should
be performed only by trained personnel authorized by the manufacturer.
Additional operating pointers are provided in Section 3.
1.2 Intended Use
The AII-2000 Palm O2 O xygen Analyzer is intended to m easure and display
the concentration of oxygen in breathing gas mixtures. The intended use is
only to verify, spo t check or c ontinuo usly monitor , oxygen concent rations in
circumst ances w her e the o xygen conc entrati on i s contr olled and s et by ot her
medical device such as oxyge n/air blender s, f low met ers or o ther contro l device found in the following m edical applications:
Anesthesia (refer to Section 5.2)
Respira t o ry Therapy – Vent ilators, Resp ir ators
Neonatal & Pediatric Incubators & Hoods
Oxygen Therapy - Intensive Care
Spot Checking Concentrator
1.3 Device Description
The AII-2 000 Pal m O2 Oxyg en Analyz er can be positi oned on a table top or
pole (tri po d wi r e sta nd and V-m ou nt dovetai l attachme nt s are mou nt ed on the
back of the device) and are readily portable from o ne location to another.
They pro vid e con ti nuous , fas t, rel iabl e a nd ac cur ate o xyg en m eas ur eme nts of
up to respiratory care systems.
The device utilizes an electrochemical galvanic fuel cell type oxygen sensor of
the type t hat is extens ivel y used to meas ure o xygen co nce ntratio ns f rom 0%
to 100% in gas streams. O xygen, the fuel f or this electroch emical transduc er,
diffus ing into the s ensor thr ough a g as permeabl e membra ne reacts ch emically at the sensi ng electro de to produ ce an elect rical curr ent o utput propo rtional to the ox yg en con ce ntra tio n in the g as phas e. T he s enso r h as an absolute zero meaning that when no oxygen is present to be chemically reacted
the LCD displays 00.0 oxygen.
The sensor’s signal output is linear over the entire range, remains virtually
constant over t he specif ied us eful li fe and drop s off sharply at the e nd. The
sensor itself requires no maintenance and is simply replaced at the end of its
useful l ife like a ba ttery. In asmuch as t he sensor i s a transdu cer in its own
right, its expected life is not affected by whether the analyzer is ON or OFF.
A batter y pow ered st ate-of -the-ar t mi cro-pr ocess or con verts t he s ensor’ s signal output representin g the parti al pressure of ox ygen in the gas str eam being
analyzed. The resulting oxygen reading is displayed by a large easy to read
backlit liquid crystal display (LCD) that has a resolution of 0.1% oxygen. The
microprocessor is controlled from a keypad and provides system diagnostics
and warning indicators for continuous monitoring that enhance both safety
and effectiveness.
Prior to shipment, every device is thoroughly tested at the factory and documented in the form of a Quality Control Certification that is included in the
Instructions for Use su pp lied with every de vice.
The manuf acturer ’s cont act info rmation and serial number o f this d evice c an
be found above the ba ttery compar tment cov er on the r ear of the d evice and
in Sect ion 2 Qu ality Cont rol C ertification.
In conclusion, Analytical Industries Inc. appreciates the opportunity to supply
this device and anticipates many years of useful service.
2
3
1.4 Declaration of Conformity
Manufacturer:
Authorized EC
Repres entativ e:
Product:
Classification:
Directives:
Standards &
Certificates:
Notified Body:
CE mark affixed: February 21, 2006
We hereby declare the above product meets the provisions of the directives
and standards specified. All supporting documents are retained on the premises of the manufacturer.
Patrick Prindibl e , QA Ma na ger
Analytical Industries Inc.
2855 Metropolitan Place, Pomona, California 91767 USA
Tel: 909-392-6900, Fax: 909-392-3665
e-mail: sales-medica l@aii1.co m , www.aii1.co m
RGV Lda.
Rua Jose Joaquim de Freitas, 247
2750-404 Cascais-Portugal
AII 2000, AII 2000A, AII 2000HC, AI I 2000 Palm O 2 Oxy-
gen Analyzers; AII 2000M Oxygen Monitor
PSR Series Oxygen Sensor s
IIb
Medical De vi ce Directive 9 3/ 4 2/ E E C , Anne x II
as amended by 2007/47/EC
510(k) K952736 O2 Sensors
510(k) K053407 O2 Analyzers
EN 12598:1999 (ISO 7767: 1997) Oxygen devices for
patient breathing mixtures – Safety requirements
Medical De vi ce Directive 9 3/ 4 2/ E E C , Anne x II
as amended by 2007/47/EC, Certificate 485 CE
ISO 9001:2008, Certificate 485
ISO 13485:2003, Cert 485A
Medical Device Regulations, F-27/ SO R-98- 282 (Cana da)
AMTAC Ce r tification Services Lim ited
Davy Ave nue, Knowhill
Milton Keynes MK5 8NL
United Kingdom
2 Quality Control Certification
Customer: ________________________ Order No. _____________ Date: _______
Model:
Sensor: ( ) AII-11-75-PO2
Electronics: A-1190 PCB Assembly Main Software Version _______________
Accessories: BATT-1008 Battery, 1.5V AA Alkaline (Qty 2)
PASS
QC Test: LCD display 3-1/2 digits ……………………………………………… ……. ________
Battery symbol displays when battery is low ……………………….. ________
Span adjustment +
Following calibration with 99-100% oxygen and flushing with
Span adjustment +
Following calibration with air (20.9% oxygen) and exposing
Options: Item No.
FITN-1009 Tee Adapter ……………………………………………………….. _____
A-3675-1 Home Care Kit (A-3675, TUBE-1007) …………………….. _____
HRWR-1157 Screwdriver ……………………………………………………… _____
HRWR-1158 Lanyard …………………………………………………………… _____
Delivery:
AII-2000 Palm O2 Oxygen Analyzer S/N _______________
( ) AII-11-75-PO2R
FITN-1112-1 Flow Diverter
P-0188 Manual, Ins tructions for Use ……………………. Inc luded ________
ambient air, oxygen reading as displayed by LCD 20.9% +
to 99-100% oxygen, LCD displays 100% +
Overall inspection for physical def ects ………………………………... ________
Qty
FITN-1065 Nipple Universal ………………………………………………….
A-3657-1 Dovetail Mounting Kit (A-3657, HRWR-1162) ………….
HRWR-1075 Dovetail Female Clamp Pole/Shelf ……………………...
(requires A-3654, CABL-1009) S/N _______________
10-30% FS with 100% oxygen calibration ________
2% _____
10-30% FS with air calibration ……………….. ________
2% ……………………. ________
____
____
____
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5
3 Safety Warnings
ALWAYS foll ow the st atem ents bel ow as t hey ar e ess ential to redu cing the ri s k o f us e err o r due to ergonomi c f eatures of the devic e o r the
environment in which t he device is in te nded to be used.
Only trained personnel who have read, understand and agree to follow
the Instructions for Use should operate the device.
Retain the Instructions for Use for future reference.
Refer service needs to trained authorized personnel. Failure to do so may
cause the dev ice to fail and vo id the warranty.
Inspect the device and accessories before operating and ensure: (a)
there is no evi de nc e of ph ysical dama ge; (b) the se nsor ( parti cul arl y t he
sensing s urf ace) and electri cal connecti ons are dry; and, ( c) the sensor is
installed and upstream from any humidifying device for accurate calibration and oxygen readings.
Calibrate: (a) with a known source of dry 100% oxygen before using
each da y or after 8 hour s of conti nuo us use; (b) when the temper atur e
or pressure of the operating environment changes; (c) if the oxygen
sensor has b een di sconne cted and r econnect ed; (d) af ter t he batt ery o r
oxygen sensor has been replaced.
Sampling flowing gas: (a) install the flow diverter and the tee-adapter in
a vertical position as shown in Section 4.4 and (b) assure there is a tight
fit between the flow diverter and tee adapter.
Sampling static, ambient or controlled atmospheres such as incubators,
oxygen hoods, tents, etc.: remove the flow diverter.
Clean the device and accessories in accordance with Section 6.1.2.
Battery replacement Section 6.2: ( a) replace t he batteries within tw enty-
four (2 4) hour s of the bat t ery s ymb ol appearin g o n LCD di s play
calibrate the analyzer after repla cing the batteries.
Oxygen sensor installation or replacement Section 6.3: allow the new
sensor to stabilize for 15-20 minutes in ambient air before attempting to
calibrate.
Store th e de vice b y turni ng t he po wer OFF an d rem ovin g t he ba tteri es i f
the device will not be operat ed for over thirty (3 0) days.
Attempt to repeat the procedure that caused a perceived malfunction
and refer to troubleshooting hints in Section 7 before concluding the
device is faulty. If in doubt, contact the manufacturer for assistance.
and (b)
NEVER o perate the d evice in any m anner des cribed below doing so
may compromise the clinical condition or the safety of patients, users
or other persons.
If the reading is unstable or a malfunc tion is suspect ed.
After the battery symbol appears in the LCD display.
Near eq uipment capable of emitting high lev els of el ectromag netic radia-
tion (EMI) or radio frequency interference (RFI).
Expose the device; particularly the LCD display or sensor to sources of
extreme heat, cold or excessive sunlight beyond the device’s storage temperature range, re fer to Section 8 for extended p eriods of ti me.
In a gas stream with a vacuum greater than 14” water column.
Immerse the device, oxygen sensor or coiled cable in any liquid.
Outside of the parameters specified in Section 8 particularly at flow rates
greater t han 10 l iters per minute - t he bac kpressure generat ed produc es
erroneously high oxygen readings.
Calibrate: (a) with 20.9% oxygen or room air with the intent of taking
oxygen measurements at oxyg en levels above 30% oxygen; (b) i n a humidified gas stream or atmosphere; (c) without allowing a newly installed
sensor to sta bilize for 15 - 20 m inutes in ambient air.
Attempt to sterilize, autoclave, liquid sterilize, immerse in any liquid or
expose the device or accessories to steam, ethylene oxide or radiation
sterilization.
In the presence of fl amm able anest hetic gases .
Open t he main c ompar tment of th e devic e, ex cept to c hange t he in tegral
oxygen sensor.
Open the oxygen sensor or pro be th e se nsing surfa ce, refer to Secti on 10
in the event the sensor should leak and someo ne comes in co ntact with
the electrolyte from inside the sensor.
Optional remote sensor with a cable that appears worn, torn or cracked,
or, allo w an excess l e ngth of c abl e near the pat ient’s he ad or neck; secure
it to the bed rail or other suitable object to avoid the possibility of strangulation.
Allow the device or ox ygen sensor to be serviced, repaire d or altered by
anyone except trained personnel – failure to do so may endanger the
patient or damage the device rendering the warranty null and void.
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7
4 Start-Up
4.1 Contents of Shipp ing Container:
The contents include:
AII-2000 Palm O2 Oxygen Analyzer
FITN-1112-1 Flow Diverter
P-1088 Instruction for Use
Note: See secti on 6.5 for rem ote sens or optio n
and Section 8. 1 for optional accesso ries.
The devic e is shipped w ith the batteri es
and oxygen sensor installed at the factory
and is ready for calibration and use.
Any optio nal equipm ent is sec ured in a plast ic bags and stored ne xt to the
analyzer in the shipping container.
Inspect the box and contents for shipping damage. If any component appears
damaged, do not attempt to o perate th e d evice an d contact the man uf acturer
immediately, refer t o section 9.
4.2 Controls
The analyzer employs a micro-processor
that is controlled by two (2) pushbuttons
located on the keypad on the front cover.
1. CAL init iates the ca libration rou t ine.
2. ON/OFF sends power to the electronics
4.3 Start-Up Test
Pressing the ON / O F F key, above right, no t onl y supplies power to the electronics but initiates diagnostic
tests of the electronics and battery voltage.
Low battery voltage detected during the Start
-Up Test or norm al op erati on caus es th e LCD
display to alternate between LO and the
oxygen value in the SAMPLING mode.
The sensor’s signal output must be confirmed by calibrating the device as described
in the follo wing section.
4.4 Calibration
Electro chem ical oxy ge n sens ors ge ner at e sli ghtl y di ff erent sign al o utput s under
identical conditions due to variations in the thickness of the sensing membrane
and manufacturing proces s .
Simulate the application for optimum accuracy: Review Sections 3
Safety Warnings and 5.2 Application Considerations before proceeding.
The devic es are desig ned to meet t he requirem ents for bo th ambient
and elevat ed oxygen meas urements but should NEVER be calibrated
with air or 21% oxyge n with th e int ent of ta king ox ygen me asur eme nts
at oxyge n levels above 30% oxygen.
Accordin gly, the d evices may be calibr ated with ei ther air (20.9%) or
100% oxygen which req uires the user to m ake a conscious de cision to
bypass or skip the recommended 100% oxygen calibration.
Set-Up:
Stat ic Atmosphere Flowing Gas St ream Flowin g from Tank
8
9
Procedure
Calibrate: (a) with a known source of dry
100% or 21% ox ygen before using eac h day
or after 8 hour s of conti nuous use; (b) when
the tem peratur e or press ure of the op eratin g
environm ent changes; (c) if the o xygen sensor has
been disconnected and reconnected; (d) after the
battery or oxygen sensor has been replaced.
1. Expose the sensor to the calibration gas (refer
to prec eding s ection) for a ppro ximatel y 30 s econds to allow the sensor to stab ilize.
2. Continue expo sing the s ensor to the cali bratio n
gas until the calibrat ion routine is c o mplete.
3. Press and hold the CAL pushbutton for three (3)
second s t o in itiate the calib r ation rou t ine.
4. The LCD displays CAL, top right, during the
calibration routine which take s 15-20 second s .
5. The software determines from the sensor’s
signal o utput w hether the devi ce is bei ng cali brated with 100% or 21% oxygen.
6. If the calibration is successful, the LCD will
display, middle and bottom right, the oxygen
value of the calibration gas and ret urns to the
SAMPLING mode.
7. Remove the calibration gas and begin sam-
pling.
Calibration Fails
If the calibration fa ils , the LCD will display ERR as illustrated.
An unsucc essf ul cali bratio n can be ca used by s ever al
problems with the sensor, cali bration gas or
electronics. Dropping the device will damage
the sensor an d electroni cs .
Do not proceed until corrective action is taken
and the dev ice is calibrate d successfully.
If after three (3) unsuccessful attempts to
calibrate: review section 7 for po ssi ble ca uses
and corrective action or contact Analytical
Industries Inc. at 909-392-6900.
4.5 Mounting
The devic e can be m ounted to a 1” diamet er pole or a book shel f using th e
optional Dovetail Mounting Kit (P/N A-3675-1) and Dovetail Female Clamp Pole/
Shelf (P/N HRWR-1075) as illust r ated below.
10
The dov etail male br acket, to p left and mi ddle, is se cured to t he rear of the
enclosure with one (1) screw and held in place by registration holes molded
into the enclosure.
The 1” diameter dovetail female, top right, clamp pole/shelf is an optional accessor y commonly found in m edical applications.
The v-shaped male component simply slides into and out of the pole or shelf
mounted female section.
11
5 Operation
5.1 Principle of Operation
The AII-2000 Palm O2 Oxygen Analyzer utilizes an electrochemical galvanic fuel
cell type oxygen sensor of the type that is extensively used to measure oxygen
concentrations from 0% to 100% in gas streams. Oxygen, the fuel for this
electro chemical tra nsduc er, di ffus ing i nto t he s ensor t hrou gh a gas p ermeabl e
membra ne reacts chem ically at th e sensing elec trode to prod uce an elec trical
current output pr oportional to the ox ygen co ncentration in t he gas phas e. Th e
sensor has an absolute zero meaning that when no oxygen is present to be
chemically reacted th e LCD displays 00 .0 oxygen.
The sens o r’ s s i gnal out put is l i near over the entire ra nge, rem ai ns vi r tual l y constant over th e s pecifi ed us eful l i f e and dro p s of f sharply at the end. The sensor
itself re quires no mainte nance and is simply r eplaced at the end of its useful life
like a battery. Inasmuch as the sensor is a trans ducer in its own right, its expected life is not affected by whether the analyzer is ON or OFF.
The relationship between the sensor’s signal and changes with the oxygen
concentration is both proportional and linear, thus allowing single point
calibrati on . Ot h er factors that ca n affect the si gn al o u tput are d es cr ibed
in Section 5.2 Application Considerations and Section 3 Safety Warnings
which sho uld be read before use.
Historic ally, the expected life of galvanic fuel type sensors has been specifie d a s
“in air (20.9% O
type s ens or i s inv ersel y aff ect ed b y c ha nges i n t he aver ag e o xyg en conc e ntration, t em p er ature and pr es s ure it i s exposed to dur i n g its us ef ul lif e. For example, the AII-11-75-P O2 an d AI I-11- 75-P O2 R sensors have a 32 mo nt h exp ected
life in air (20.9% oxygen) at 25°C and ambient pressur e, however, in a 100%
oxygen atmosphere the expected life is 12.6 months [60mo/(100%/20.9%)].
AII-2000 Palm O2 Oxygen Analyzer is battery powered by (2) AA alkaline batteries a nd controll ed by a s t at e- o f -t h e-art micr opr o c es s or . The batt eries provi de
enough po wer to oper ate the a nalyzer cont inuousl y for approxim ately 13,0 00
hours. Both devices utilize a membrane type keypad for users to communicate
commands to the m icro process or. The di gital electro nics pro vid e featur es suc h
as system diagnostics and warning indicators that enhance both safety and
effectiveness. The design criteria, quality progr am and performance features
ensure reliable and accurate oxygen measurements.
) at 25°C a nd 760mm Hg”. T he a ctual li f e of an y g alvanic fuel
2
5.2 Application Consideratio ns
Effect of Anesthetic Agents
The AII-2000 Palm O2 Oxygen Analyzer utilizes an electrochemical galvanic
fuel cell type sensor, model AII-11-75-PO2, that has been characterized by its
gas permeable s ens i n g m embrane that all o w s the gas to b e a nalyzed to di f f us e
into the sensor where oxygen can be re acted. The displayed oxygen concentration of all sensors of this design decreases in the presence of anesthesia gases.
EN 12598:1999/ISO 7767:1997 (E) established standards for the maximum
error all ow able o ver a giv en dur ati on. The a nes thet ic a gent s li sted ( Hal oth ane,
Enflur ane, Iso fl urane , Sevo fl uran e and Des fl ura nce) wer e vapor iz ed into a gas
str eam of 30% oxygen / 70 % nitrous oxide.
Gas Test Level Decrease in O
Helium 50%, Balance O
Nitrous Oxide 80%, Balance O
Carbon Dioxide 10%, Balance O
0%
2
0%
2
0%
2
Reading
2
Halothane 4% <-1.5%
Enflurane 5% <-1.5%
Isoflurane 5% <-1.5%
Sevoflurane 5% <-1.5%
Desflurane 15% <-1.5%
The errors listed were observed after a two (2) hour exposure period. The
table above summarizes th e performance of the AI I-2000 Palm O2 electro nics
and AII-11-75-PO2 Oxygen Sensor. The above performances all meet or exceed the requirements established by EN 12598:1999/ISO 7767:1997 (E).
Do not operate any device in the presence of flammable anesthetic agents
such a s D iethal Ether o r Cyclpropane.
Note: Th e AII-11-75-PO2 Oxygen Sensor has been s pecifically designed and
tested to be compatible wi th nitrous oxide. For optimum results , mo unt o xyg en
sensor w ith the s ensing ar ea facin g down tow ard the fl oor and be flushed or
calibrated with 100% oxygen every eight (8) hours.
Effect of Temperature
All mem bra ne clad electro ch emi cal se nsor s are t emp erat ur e depe ndent d ue t o
the expa ns i o n and contr a ct i o n of the Teflon sens i n g m embrane. A s result m or e
or less of the sample gas including oxygen to be reacted diffuses into the sensor. The oxygen s ensor’s electrical current signal output varies linearly with
oxygen concent rat i o n . The sig nal al s o var i es w i th changes in ambi ent temp erature. The temperature coefficient is typically 2.54% of the signal or reading per
degree C change in temperature.
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13
The tem perature de pendent c urrent sig nal output i s compensat ed by us ing a
resistor-thermistor network. With a proper resistor-thermistor network, the
signal can be compensated to within +
5% of the oxyg en reading over the 545°C temperature range. This is the worse case situation when going from one
extreme of the operating temperature range to the other. The error will be
elimi nated wh en th e therm istor in th e temper at ure comp ensat ion n etwor k and
the electrolyte inside the sensor reach thermal equilibrium in approximately 4560 minutes.
Erroneous oxygen readings can result if the gases flowing over the
sensing area o f th e se nso r ar e no t at am bie nt t emper at ure. This oc cur s
because t he sensor i s exposed to different tem peratur es. The sens ing
area of t he se nso r is o-ri ng se aled i n th e hea ted bre athi ng ci rcuit an d the t emperature compensation network at the rear of the s ensor is e xpos ed to ambie nt
temperature.
Effect of Pressure
Electrochemical sensors actually measure the partial pressure, not the percentage, of oxygen in the gas stream they are exposed to. These sensors are accurate at a ny pressure pro vided the press ure is consta nt and the analyzer has
been calibrated at the same pressure as the sample gas measured .
For ex ample, when connec ted to a gas str eam wh ere t he pr essur e varies , t he
oxygen se nsor ca uses t he anal yz er to dis pla y f luct uati ng ox yg en r ea dings . T he
fluctuations in the readings displayed are not related to a change in the oxygen
percentage but to the change in partial pressure resulting from the alternating
breathing pressure cycles of a ventilator which increases the total pressure.
Calibrat e at t he tem perat ure and pr essur e (al titude) at whi ch t he analyzer will be operated.
Effect of Humidity
The an alyzer is no t affect ed by non -condensin g relativ e humidit y (RH). Ho wever, the use of a humidifier to introduce water vapor and increase the moisture level of the gas mixture does affect the oxygen concentration and the
resultant reading dis played by the anal yzer. The addition of water vapor increases the total pr ess ure thereby di l ut i ng or decreasi ng t h e oxygen conce ntr ation of the ga s m ixture resulting in a lower oxygen reading.
Calibrate at the temperature and pressure (altitude) at which the analyzer will b e operated, hu m idified gases cannot be 100% ox ygen.
Effect of Condens a tion
Excessiv e co ndens at ion c oll ecting on t he s ensi ng ar ea or th e el ectri cal con nections at th e rear o f t he s ensor s can adve rs ely i m pact t he per for man ce of el ectrochemical sensors. Cond e nsation bl ocks the diffusion p ath of oxygen into t he
sensor an d can r educe the ox ygen r eading t o 00.0 i f the cond ensat ion covers
the entire sensing area. Condensation on the electrical connections at the rear
of the s ensor can aff ect ox ygen re adings . R emedy either situ ation by sh aking
out the condensation and allowing the sensor to air dry.
Erroneously characterized in many instances as a sensor failure, excessive
condensation is rem edied by gently wi ping away the condensation with a soft
cloth or simply allowing the sensor to air dry.
Effect of Electromagnetic Radiation
Tested o ver a 26 MHz t o 1000 M Hz ele ctrom agneti c fiel d, the a nalyz er is s usceptibl e at al l frequencies tes ted except t hose betw ee n 93 0 an d 99 0 MHz .
Never o perate t he anal yzer near equipme nt capabl e of emi tting hi gh
levels of electromagnetic radiation. Do not continue to operate the
analyzer if the reading becomes unstable.
5.3 Calibration
Calibrating the analyzer during normal operation involves the same
precautions and pr ocedures as those describe d i n Sectio ns 4. 4 Start-up
Calibration with the sam e cautions to review Sections 3 Safety Warnings and 5.2 Application C onsidera t ion s .
5.4 Sampling
Assuming the START-UP TESTS are completed successfully the devices default
to the SAMPLING mode.
Never operate the analyzer if the reading is unstable or if a malfunction is s uspected. If calibra tion is re quired as i ndicate d herein, do not
procee d until the analyzer is calibration successfully.
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5.4.1 Flowing Gas Strea ms (Breathing Ci rc uit s , Concentrator s)
1. Pl ace the sens ing area o f the sens or into th e gas stre am
to be analyzed upstream of any humidification equipment.
2. Assure that the flow rate of the gas stream does not exceed ten (10) liters per minute. Exceeding ten (10) liters
per minute generates backpressure.
3. Check the gas stream and particularly the mechanical
connection for leaks that dilute the gas stream with am bient air.
4. Assure there are no r estricti ons in t he circ uit dow nstre am
of the sensor that could generate backpressure on the
sensor.
5. U se the flow diverter suppl ied with th e device alo ng with
the optio nal tee ad apter an d pos iti on t he s ens or v ertic al ly
for optimum results, as shown right. The flow diverter
avoids stagnation and facilitates the movement of gas to
and from the sensing ar ea of the sensor t hereby producing a more a ccurate measurem ent of the gas st ream to be
measured.
6. Install the tee-adap ter in the br e athing circuit.
7. Screw the flow diverter to the sensor.
8. Ensure the o-ring is lightly lubricated for ease of entry and
a tight seal between the flow diverter and tee adapter.
9. Insert the assembled flow diverter/sensor into the tee
allowing 100% oxygen (dry, non-humidif ied) to flow past
the sensor at a rate of 5-8 liters per minute.
10. Once the sens i ng area of the sens or is ex po s e d t o the gas
stream allow approximately sixty (60) seconds for the
reading to stabilize and observe the reading displayed by
the LCD.
5.4.2 Static Atmospheres (Incubators, Hoods, Oxygen Tents)
Expose the sensing area of the sensor to the atmosphere allowing approximately sixty (60) seconds for the reading to
stabilize and observe the reading disp layed by the L CD.
If placi ng the ent i re senso r inside the controlled at mo s phere re vi ew Section 5. 2
6 Maintenance
Review Section 3 Safety Warnings and Section 7 Troubleshooting for
guidelin es on servicing the devices.
6.1 Serviceability
Do not op en t h e m ain com partm en t of t he anal yz er, as it cont ai ns no s er vic eable parts inside. Never attempt to repair the analyzer or sensor by yourself as
you may damage the analyzer which could void the warranty.
6.1.2 Cleaning / Reuse Instructions
Clean th e devic e, oxyge n sens or and accessori es with a soft cl oth dam pened
with either water or mild isopropyl alcohol solution (70% isopropyl alcohol
solution in water), if necessary, before re-use. Allow the components to air-dry
after cleaning.
Note: The Home Care Kit is not intended for patient use, it is intended solely
for conf irming t he O
cleaning instructions apply.
6.2 Battery Replacement
The AII-2000 Palm O2 Oxygen Analyzer is p owered by two
1.5V AA alkaline batteries with an approximate life of 13,000
hours.
A low battery indicator circuit monitors the battery supply
voltage and s en ds a sign al di re ctly t o t he LC D w he n the bat tery voltage reaches a preset level that activates the battery
symbol in the LCD.
The b atteries are loc ated the top o r f ront of the an alyzer and secured by termi nals mounted directly on the PCB Assembly.
concentration in Oxygen Concentrators. Accordingly, no
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Procedure:
1. Open the enclosure: Remove the four (4) Phillips
screws from the rear of the enclosure, FIG 1.
2. Separate the enclosure and an place it on a flat
surface, FIG 2.
3. Remove t he bat ter y: G ras p the mi ddle of a bat ter y
and gently pull stra ight up.
4. Locate the positive (+) and negative (-) terminals
on the battery.
FIG 1
5. Assure the battery contacts are clean.
6. Align the battery’s positive (+) terminal with the
corresponding (+) battery symbol printed on the
PCB Assembly.
7. Install the bat tery: Al i gn t he bat tery over the term inal clip mounted on the PCB Assembly and press
down until the battery snaps into place, FIG 2.
8. Repeat steps 3-7 with the remaining battery.
FIG 2
9. Reassemble the device as shown in section 6.4
10. Calibrate, see section 4.4, the device after replacing the batteries.
6.3 Oxygen Sensor Replacement - Standard Integral Sensor
The desi gn of th e electr onics is int ended f or only t he An alytical Indus tries I nc.
AII-11-75-PO2 or AII-11-75-P O2R Oxygen Sensors. Use of a different o xygen
senso r may result in an erroneous oxyg en reading .
NEVER - Open th e oxygen s ensor or probe t he sensin g surfac e, refer
to Section 10 in the event the sensor should leak and someone comes
in contact with the electrolyte from inside the sensor.
Procedure - Standard Integral Sensor
1. See 6.2 step 1 above.
2. See 6.2 step 2 above.
3. Disconnect the oxygen sensor: Press
down on the latch arm, see arrow,
and pull bac k on the m ale connecto r
attached to the sensor from the female connector attached to the PCB
Assembly, FIG 3.
FIG 3
4. Remove the oxygen sensor, FIG 4:
(a) Lift up the rear of the sensor where
the connector wires are attached.
(b) Pull the front end of the sensor out
of the retaining collar, arrow right,
molded into the gasket that seals the
two sections of the enclosure.
5. Insta l l the new oxygen sensor:
(a) Align the rear of the sensor as shown
in FIG 5, but do not install.
FIG 4
(b) Insert the sensor into the molded collar, arrow
FIG 6, and align the outer shoulder with the front edge of the collar.
(c) Locate the registration peg indicated by the arrow circled in FIG 5.
(d) Gently press the hole where the wires exit the sensor onto the
registration peg, FIG 5.
FIG 5
FIG 6
6. Connect the sensor, reverse section step 3.
7. Reassemble the device as shown in section 6.4.
8. Calibrate, see section 4.4, the device after replacing
the sensor.
6.4 Reassembly
To ens ure pro per operatio n after repl acing the se nsor or
batteries check the following poin ts:
1. The batter ies are secured in th e t erminal clip.
FIG 7
2. The seal ing g asket is r egi stere d o nto t he 4 pegs mol ded i nto the
bottom section of the enclosure .
3. The senso r is r egister ed as show n i n FI G 5 a nd FI G 7 and the con necti ng
wires ar e not be nt or bo und wh en cl osi ng up th e encl osur e and ti gh teni ng
the Phillips s crews, FIG 6.
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6.5 Oxygen Sensor Replacement - Optional Remote Sensor
The design of the electronics is intended for only the Analytical Industries Inc.
AII-11-75-PO2 or AII-11-75 -PO2R Oxygen Sensors. U se of a different oxygen
senso r may result in an erroneous oxyg en reading .
NEVER - O pen the oxygen sensor or probe the
sensing surface, refer to Section 10 in the event
the sensor should leak and someone comes in
contact with the electrolyte from inside the sensor.
With this configuration the integral oxygen sensor is re-
placed by a connector module (P/N A-3654) . The e xternal
oxygen sensor (P/N AII-11-75-PO2 R) is connected to the
module by a cable (P/N CABL-1009) w ith phone plug a nd
locking nut attach ed at both ends. Th e cable is co i l ed a nd
extends to 6 ft.
Procedure - Optional Remote Sensor
1. Unscrew the locking nu t fro m the connect or located
at the rear of the oxygen sensor.
2. Remove the new replacement sensor from its shipping
packaging.
3. Insert the phone plug into the connector at the rear
of the oxygen sensor and finger tighten the locking nut.
4. Allow the new replacement ox ygen sensor to sta bilize
for approximately 30 minutes in its new environment.
5. Calibra te, see section 4.4, after re placing the re mote
oxygen sensor.
7 Troubleshooting
If the recom men ded corr ective a ction does no t resol ve the probl em retur n the
device to the factory for service.
Symptom Corrective Action
Device appears to be physically dam age d
No display when analyzer is
turned ON
‘LO’ displayed when analyzer is
turned ON or in use.
‘ERR’ displa yed wh en anal yzer
fails calibration
No response to keypad Rep lace ba ttery
Cannot turn device OFF Calibration routine in process – wait until
Reading displayed by LCD
does not chan ge when oxy gen
level changes
Turn device ON – if it successful passes
calibration – proceed
Replace bat teries
Check battery polarity
Check and/ or cl ean batter y co ntacts
Replace battery and calibrate device
Replace oxygen sensor
completed
Replace sensor
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After calibration in 100% dry
oxygen, an alyz er readin g dri fts
more than 2% over 8 hours
Reading does not stabilize or
fluctuates erratically
Check p r im ary oxygen delivery device
Replac e sensor that i s nearing t he end of
its useful life
Relocate analyzer away source of RF or
electromagnetic radiation emissions.
Wait 5 minu te s and repeat calibration
Replace sensor, repeat calibration
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8 Specifications
Accu ra cy: < 2% of FS range under constant co nditions
Analysis: 0-100% oxygen
Alarms: Analyzer none
Calibration: Certified dry 100% oxygen or air after 8 hrs of use
Compensation: Temperature
Connections: 1x16mm thread or o-ring diverter
Controls: Soft touch keypad for ON/OFF and CAL
Dimensions: 2.72” x 4.1” x 1.35”; weight 7 oz. (196 grams)
Display: 3 digit LCD 1.1” x .625”; resolution 0.1% O
Flow Sen sitivity: None between 0.2 t o 10 liters per minute
Humidity: Non-condensing 0-95% RH
Linearity: +
Pressure: Inlet – ambient or regulated; vent - atmospheric
Power:
Respo nse Time: 90% of final FS reading in 1 0 seconds
Sensitivity: < 0.5% o f FS range
Sensor: AII-11-75-PO2; optional remote sensor AII-11-75-PO2R
Sensor Life: 32 months in air at 25ºC and 1 atmosphere
Storage Temp.: -20º to 60ºC (-4ºF to 140ºF) on intermittent basis
Temp. Range: 5º to 45ºC (41ºF to 113ºF)
Warm-up Time: None
Warranty: 12 months analyzer; 12 months sensor (any application)
1% under constant conditions
(2) 1.5V AA alkaline batteries; 13,000 hrs of use
2
8.1 Spare Parts & Optional Accesso ries
Spare Parts:
AII-11-75-PO2 Oxygen Sensor
BATT-1008 Battery (2x) 1.5V AA Alkaline
P-1087 Instructions for Use
A-1162 PCB Assy Main
FITN-1112-1 Flow Diverter, O-ring Seal
Optional Accessories:
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HRWR-1157 Screwdriver
HRWR-1158 Lanyard
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9 Warranty
Coverage
Under nor mal o perati ng co nditions , th e anal yzer an d sens ors ar e war rante d to
be free of defects in materials and workm anship for the period s pecif ied in the
current published specifications. To make a wa r ra nt y claim, you must return the
item properly packaged and postage prepaid to:
Analytical Industries in their sole discretion shall determine the nature of the
defect. If the item is determined to be eligible for warranty we will repair it or,
at our option, replace it at no charge to you. If w e choose to r epair your item,
we may us e new or reco ndition ed repl acem ent par ts of t he same o r upgr aded
design. This is the only warranty we will give and it sets forth all our responsibilities, there are no oth er express or implied warran t ies.
The warranty begins with the date of shipment from Analytical Industries and is
limited to the first customer who submits a claim for a given serial number
which must be in place and readable to be eligible for warranty and will not
extend to more than one customer or beyond the warranty period under any
conditions.
Exclusions
This warranty does not cover normal wear and tear; corrosion; damage while in
transit; damage resulting from misuse or abuse; lack of proper maintenance;
unauthorized repair or modification of the analyzer; fire; flood; explosion or
other fa ilure to follow t he Owner’s Manual.
Limitations
Analytical Industries shall not liable for losses or damages of any kind; loss of
use of t he analyz er; incide ntal or co nsequenti al losses o r damages ; damages
resulting from alterations, misuse, abuse, lack of proper maintenance; unauthorized repair or modification of the analyzer.
Service
Contact us between 8:00am and 5:00pm PST Mon day thru Thursday or before
12:00pm on Friday. Trained technicians will assist you in diagnosing the problem and determ i ning the appropriat e co urse of action.
Analytical Industries Inc.
2855 Metropolitan Place
Pomona, Ca 91767 USA
T: 909-392-6900, F: 909-392-3665
E: sales-medical@aii1.com
, W: www.aii1.com
10 Material Safety Data Sheet (MSDS)
Product name Electrochemical Galvanic Fuel Cell Oxygen Sensor
Exposure Sealed device with protective coverings, normally no hazard
Ingredients Carcinogens - none; Potassium Hydroxide (KOH), Lead (Pb)
Properties
Flash Points Not applicable, non-flammable
React ivity Stable; avoid strong ac ids, emits fumes when heated
Health Hazard KOH entry via ingestion - harmful or fatal if swallowed;
Symptom s Eye con ta ct - burning sens at io n; skin conta ct - slick feeling
Protection Ventilation - none; eye - safety glasses; hands - gloves
Precautions Do not remov e Teflon a nd PCB coveri ngs; do not probe with
Action KOH
Leak
10.1 Disposal
Oxygen sensors and batteries should be disposed of in accordance with local
regulations for batteries.
Completely soluble in H
eye - corrosive, possible loss of vision;
skin con ta ct - corrosive, possible che mical burn.
Liquid inhalation is unlikely.
Lead - known to caus e bir t h defects, co ntact unli kely
sharp objects; avoid contact with eyes, skin and clothing.
Use rubber gloves, safety glasses and H
surfaces repeatedly with liberal amounts of H
WEEE regulations prohibit electronic products including the Helium a nd enviro nmental s ensors fr om being placed in househol d
trash bins.
Electronic products should be disposed of in accordance with local
regulations.
2O; ev aporation similar to H2O
2O and flush all
2O
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