Analytical Industries AII-2000 M User Manual

510(k) K952736 O2 Sensor
510(k) K053407 O2 Analyzers

EN 12598:1999 / ISO 7767: 1997
(Oxygen monitors for patient breathing
mixtures – Particular requirements).

EC: Medical Device Directive: 93/42/EEC,
Annex II as Amended by 2007/47/EC,
Certificate #485CE

ISO 9001:2008, Certificate #485
Authorized EC Representative:

RGV Lda.
Rua Jose Joaquim de Freitas, 247
2750-4 04 Cas ca is-Portu ga l

Health Canada: Medical Device Regula­tions, F-27/ SOR-98-282

ISO 13485:2003, Certificate #485B

AII-2000 A

AII-2000 HC

Copyright © 10/10 All Rights Reserved

Analytical Industries Inc.,
2855 Metropolitan, Pomona, CA 91767 U SA.
Tel: [phone], Fax: [phone]
e-mail: [e-mail], web: www.aii1.com

This manual may not be reproduced in whole or in part without
the prior written consent of Analytical Industries Inc.

AII-2000 M

Table of Contents

1 Introduction

1.1 Indications for Use

1.2 Intended Use

1.3 Device Description

1.4 Declaration of Conformity

2 Quality Control Certification
3 Safety Warnings
4 Start-up

4.1 Contents of Shipping Container

4.2 Install Batteries

4.3 Install Oxygen Sensor

4.4 Controls

4.5 Start-up Test

4.6 Alarms (AII-2000 M Oxygen Monitor)

4.7 Calibration

4.8 Mounting

5 Operation

5.1 Principle of Operation

5.2 Application Conside ra t io ns

5.3 Calibration

5.4 Sampling

6 Maintenance

6.1 Service ability

6.2 Battery Replacement

6.3 Oxygen Sensor Replacement

7 Troubleshooting
8 Specifications

8.1 Spare Parts & Accessories

9 Warranty

10 Material Safety Data Sheet (MSDS)

10.1 Disposal

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
Series Oxygen Analyzers & Monitors.

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, unauthorize d repair or improper maintenanc e o f th e device.

1.1 Indications for Use

The AII 2000 S eries Oxygen Analyzers & Monitor are int ended to m easure a nd
display the concentration of oxygen in breathing gas mixtures. The intended
use is only to v er i fy, spot chec k or continuously monit or , oxyge n conce nt rat i ons
in circumstances where the oxygen concentration is controlled and set by other
medical device such as oxygen/air blenders, flow m eters 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 uch a way that w h en used u nder the co ndi tions
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 restrict s this device to sale by or on the order of a physician.
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, ethylene oxide or ra diation sterilization.

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The device is i ntended t o be re - usable. S ho ul d t h e device o r access o ri 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 a nalyzer near eq ui pm ent cap abl e of emittin g hi gh level s o f
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 S eries Oxygen Analyzers & Monitors are intended to measure
and displ ay the conce ntration of o xygen in breat hing gas mi xtures. The in­tended use i s o nly to veri fy, s pot ch eck or co nti nuous l y mo ni tor , o xyg en co n­centrations in circumstances where the oxygen concentration is controlled and
set by other me dical d evice s uc h as o x ygen/air ble nders, f low me ter s or other
contr o l device found in the fo llo wing medical applications:

Anesthesia (refer to Section 5.2)
Respira t o ry Therapy – Ventilators, Respir ators
Neonatal & Pediatric Incubators & Hoods
Oxygen Therapy - Intensive Care
Spot Checking Concentrator

1.3 Device Description

The AII 2000 Seri es Oxygen Anal yzers and Mo nitor can be pos itioned on a
table to p or pole ( tripod wire stand and V-moun t dovetail attach ments are
mounted on the back of the device) and are readily portable from one location
to another. They provide continuous, fast, reliable and accurate oxygen meas­urements of up to respiratory care systems.

The devices utilize 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, rem ains 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 t he partial pressure of ox ygen in the gas stream bei ng
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 features like system
diagnostics, warning indicators, controls and an alarm capability for continu­ous monitoring that enhance both safety and effectivene ss.

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 supp lied with every device.

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 Control C ertificat io n.

In conclusion, Analytical Industries Inc. appreciates the opportunity to supply
this device and anticipates many years of useful service.

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1.4 Declaration of Conformity

Manufacturer:

Analytical Industries Inc.

2855 Metropolitan Place, Pomona, California 91767 USA
Tel: [phone], Fax: [phone]
e-mail: [e-mail] , www.aii1.com

Authorized EC
Repres entativ e:

RGV Lda.
Rua Jose Joaquim de Freitas, 247
2750-404 Cascais-Portugal

Product:

AII 2000, AII 2000A, AII 2000 HC, A I I 2000 TruO2 Ox ygen

Analyzers; AII 2000M Oxygen Monitor

PSR Series Oxygen Senso rs
Classification:
Directives:

IIb

Medical De vice Direct iv e 93/4 2/E EC, Annex II as am ended

by 2007/47/EC
Standards &

Certificates:

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 vice Direct iv e 93/4 2/E EC, Annex II as am ended

by 2007/47/EC, Certificate 485CE

ISO 9001:2008, Certificate 485

ISO 13485:2003, Cert 485A

Medical Device Regulations, F-27/ SO R-98- 282 (Cana da)
Notified Body:

AMTAC Ce r tification Services Limit ed

Davy Ave nue, Knowhill

Milton Keynes MK5 8NL

United Kingdom
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 Prindible, QA Ma na ger

2 Quality Control Certification

Customer: ________________________ Order No. _____________ Date: _______
Model: ( ) AII-2000 A Oxygen Analyzer

Sensor: ( ) AII-11-60 or ( ) AII-11-60-HC S/N _______________

Electronics: A-1162 PCB Assembly Main Software Version _______________
Accessories: AII-2000 A / M:

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 ……………………………………………………….. _____

ENCL-1072 Carrying Case ……………………………………………………. _____

Other: _____
Delivery:

( ) AII-2000 M Oxygen Monitor
( ) AII-2000 HC Oxygen Analyzer S/N _______________

FITN-1112-1 Flow Diverter
AII-2000 HC: A-3675 Adapter, 5/32” Tube to Sensor

TUBE-1007 1/4” Tubing 7 ft. with Adapter
All units: BATT-1008 Battery, 1.5V AA (Qty 2)

P-0187 Manual, Instructions for Use ……… Included ______

ambient air, oxygen reading as displayed by LCD 20.9% +

to 99-100% oxygen, LCD displays 100% +
Overall inspection for physical defects ………………………………... ______

HRWR-1075 Dovetail Female Clamp Pole/Shelf ………………………

CABL-1006 Cable, Coiled Phone Jack

10-30% FS with 100% oxygen calibration ______

2% ____

10-30% FS with air calibration ……………….. ______

2% ……………………. ______

Qty

____

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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 er gonomic f eatures of t h e device o r t he
environment in which the device is inte 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 void 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 elect ri cal conn ecti ons ar e 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 ha s been repla ce.

 Sampling flowing gas: (a) install the flow diverter and the tee-adapter in

a vertical position as shown in Section 4.3 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 battery symbol appearin g o n LCD di s play
calibrate the analyze r aft er replacing th e ba tteries.

 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 operated 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 malfunct io n is suspected.
 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 ra n ge, r efer to Sectio n 8 for e xtended periods o f time .

 In a gas stream with a vacuum greater than 14” water column.
 Immerse the device, oxyg en sensor or coile d cable in any liq uid.
 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 am m abl e anes theti c gas es.
 Open t he main c ompar tment of th e devic e, ex cept to c hange t he in tegral

oxygen sensor of the AII-2000 HC Oxygen Analyzer.

 Open the oxygen sensor or pro be th e se nsing surfa ce, refer to S ecti on 10

in the event the sensor should leak and someo ne comes in co ntact with
the electrolyte from inside the sensor.

 Operate with a cable that appears worn, torn or cracked, or, allow an

excess length of cabl e near the patient’s head o r neck; secure it to the bed
rail or ot her suitable object to avoid the p o s s ibility 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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4 Start-Up

4.1 Contents of Shipp ing Container:

4.1.1 AII 2000 A Oxygen Analy zer, and AI I 2000 M Oxygen Monitor:

ENCL-1061 V-mount retainer (attached)
ENCL-1066 Tripod wire stand (attached)
AII-11-60 Oxygen Sensor
BATT-1008 Battery, AA 1.5V Alkaline (Qty 2)
CABL-1006 Cable, Coiled Phone Jack
FITN-1065 Flow diverter
P-1087 Instructions for Use

4.1.1 AII 2000 HC Oxygen Analyzer, Home Care:

ENCL-1061 V-mount retainer (attached)
ENCL-1066 Tripod wire stand (attached)
AII-11-60-HC Oxygen Sensor (installed inside analyzer)
BATT-1008 Battery, AA 1.5V Alkaline (Qty 2)
TUBE-1007 Tubing, 1/4” Tubing 7 ft. with Adapter
P-1087 Instructions for Use

Inspect t he box and cont ents for shippi ng damage. If t he device or
compone nts app ear dam age d, do not a ttem pt to oper ate t he devi ce -
contact the manufacturer immediately, refer to section 9.

OR

AND

AND

4.2 Install Batteries

All devices are powered by two 1.5V AA alkaline batteries which must be in­stalled before the device can be operated.

The battery compartment is located at the rear of all devices. Initially
this proc edure c an be som ewhat dif ficult. C are sho uld be take n not to
damage the case when removing the battery compartment cover.

4.2.1 Procedure:

1. Remove the device and the (2) AA 1.5V Alkaline batteries from the foam
shipping container.

2. Turn t he devi ce over so the s hortest r aised line on the batt ery co mpart­ment cover is pointing away from you.

3. Lift the tripod wire stand up and away from the case.

4. Grasp the c ase wit h both hands, use y our thum bs pres s dow n firm ly on
the raised lines and push the battery compartment cover away from you.

5. Locate the positive (+) and negative (-) terminals on the battery.

6. Assure the battery contacts are clean.

7. Ali gn one batt ery’s posi tive (+) termin al with t he corr espondin g (+) bat­tery sy mbo l m o lded into the case.

8. Insert the battery into the compartment.

9. Repeat with the remaining battery.

10. Replace the battery comp artment cover, make sure it snaps into p osition
and is secured flush against the case. Replace the wire stand as required.

Replac e the bat teri es w ithi n tw e nty- four (24) ho ur s of the b att ery sym ­bol appearing on LCD display because batteries decline at different
rates. Calibrate the dev ice after repla cing the batteries.

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