Analytical Industries AII-2000 Palm O2 User Manual
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
1
2
3
4
8
8
8
9
11
12
13
15
15
17
17
18
19
20
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% ……………………. ________
____
____
____
4
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.
6
7
Loading...