Analizador de Oxigeno Analytical (Ingles) PDF
Analizador de Oxigeno Analytical (Ingles) PDF
Analizador de Oxigeno Analytical (Ingles) PDF
Authorized EC Representative:
RGV Lda.
Rua Jose Joaquim de Freitas, 247
2750-404 Cascais-Portugal AII-2000 A
AII-2000 HC
3 Safety Warnings Note: Analytical Industries Inc. cannot warrant any damage resulting from the
misuse, unauthorized repair or improper maintenance of the device.
4 Start-up
4.1 Contents of Shipping Container 1.1 Indications for Use
4.2 Install Batteries The AII 2000 Series Oxygen Analyzers & Monitor are intended to measure and
4.3 Install Oxygen Sensor display the concentration of oxygen in breathing gas mixtures. The intended
4.4 Controls use is only to verify, spot check or continuously monitor, oxygen concentrations
4.5 Start-up Test in circumstances where the oxygen concentration is controlled and set by other
4.6 Alarms (AII-2000 M Oxygen Monitor) medical device such as oxygen/air blenders, flow meters or other control de-
4.7 Calibration vice.
4.8 Mounting
Users must read the following statements as they are essential to re-
5 Operation ducing the risk of use error due to ergonomic features of the device or
5.1 Principle of Operation the environment in which the device is intended to be used.
5.2 Application Considerations
5.3 Calibration The devices as identified in Section 1.4 Declaration of Conformity have been
5.4 Sampling designed and manufactured in such a way that when used under the conditions
and for the purposes intended, they will not compromise the clinical condition
6 Maintenance or the safety of patients, or safety of the users or other persons.
6.1 Serviceability
6.2 Battery Replacement Federal law restricts this device to sale by or on the order of a physician.
6.3 Oxygen Sensor Replacement
Conformity with essential requirements has been demonstrated by verifying the
7 Troubleshooting performance of the device under normal conditions, bench testing, pre-clinical
and simulated clinical evaluations and determining that undesirable malfunc-
8 Specifications
tions constitute minimal risk to patients and users.
8.1 Spare Parts & Accessories
Particular requirements for sterilization do not apply to these devices. Do not
9 Warranty sterilize, autoclave, liquid sterilize, immerse in any liquid or expose the device
10 Material Safety Data Sheet (MSDS) or accessories to steam, ethylene oxide or radiation sterilization.
10.1 Disposal
i 1
The device is intended to be re-usable. Should the device or accessories come 1.3 Device Description
in contact with patient bodily fluids, either dispose of the device or clean with The AII 2000 Series Oxygen Analyzers and Monitor can be positioned on a
a soft cloth dampened with 70% isopropyl alcohol solution in water and allow table top or pole (tripod wire stand and V-mount dovetail attachments are
the components to air-dry before re-use . mounted on the back of the device) and are readily portable from one location
to another. They provide continuous, fast, reliable and accurate oxygen meas-
The device and accessories are not intended to transport or store any medi- urements of up to respiratory care systems.
cines, body liquids or other substances that can be administered or removed
from the body, and, do not contain any latex, human blood derivatives, phtha- The devices utilize an electrochemical galvanic fuel cell type oxygen sensor of
lates, carcinogens or other reproductive toxics. the type that is extensively used to measure oxygen concentrations from 0%
to 100% in gas streams. Oxygen, the fuel for this electrochemical transducer,
Calibrate the device with 100% oxygen before using each day or after 8 hours diffusing into the sensor through a gas permeable membrane reacts chemi-
of continuous use. In the event the device fails to calibrate or if the reading cally at the sensing electrode to produce an electrical current output propor-
becomes, do not attempt to use the device. Contact the manufacturer for tional to the oxygen concentration in the gas phase. The sensor has an abso-
assistance. lute zero meaning that when no oxygen is present to be chemically reacted
the LCD displays 00.0 oxygen.
Do not operate the analyzer near equipment capable of emitting high levels of
electromagnetic radiation as the reading may become unstable. The sensor’s signal output is linear over the entire range, remains virtually
constant over the specified useful life and drops off sharply at the end. The
In order to obtain optimum performance, the operation of the device must be sensor itself requires no maintenance and is simply replaced at the end of its
performed in accordance with these Instructions for Use. Maintenance should useful life like a battery. Inasmuch as the sensor is a transducer in its own
be performed only by trained personnel authorized by the manufacturer. right, its expected life is not affected by whether the analyzer is ON or OFF.
Additional operating pointers are provided in Section 3. A battery powered state-of-the-art micro-processor converts the sensor’s sig-
nal output representing the partial pressure of oxygen in the gas stream being
1.2 Intended Use analyzed. The resulting oxygen reading is displayed by a large easy to read
The AII 2000 Series Oxygen Analyzers & Monitors are intended to measure backlit liquid crystal display (LCD) that has a resolution of 0.1% oxygen. The
and display the concentration of oxygen in breathing gas mixtures. The in- microprocessor is controlled from a keypad and provides features like system
tended use is only to verify, spot check or continuously monitor, oxygen con- diagnostics, warning indicators, controls and an alarm capability for continu-
centrations in circumstances where the oxygen concentration is controlled and ous monitoring that enhance both safety and effectiveness.
set by other medical device such as oxygen/air blenders, flow meters or other
control device found in the following medical applications: Prior to shipment, every device is thoroughly tested at the factory and docu-
mented in the form of a Quality Control Certification that is included in the
Anesthesia (refer to Section 5.2) Instructions for Use supplied with every device.
Respiratory Therapy – Ventilators, Respirators
Neonatal & Pediatric Incubators & Hoods The manufacturer’s contact information and serial number of this device can
Oxygen Therapy - Intensive Care be found above the battery compartment cover on the rear of the device and
Spot Checking Concentrator in Section 2 Quality Control Certification.
2 3
1.4 Declaration of Conformity
2 Quality Control Certification
Manufacturer: Analytical Industries Inc.
2855 Metropolitan Place, Pomona, California 91767 USA
Customer: ________________________ Order No. _____________ Date: _______
Tel: 909-392-6900, Fax: 909-392-3665
e-mail: sales-medical@aii1.com, www.aii1.com Model: ( ) AII-2000 A Oxygen Analyzer
( ) AII-2000 M Oxygen Monitor
Authorized EC RGV Lda. ( ) AII-2000 HC Oxygen Analyzer S/N _______________
Representative: Rua Jose Joaquim de Freitas, 247
2750-404 Cascais-Portugal Sensor: ( ) AII-11-60 or ( ) AII-11-60-HC S/N _______________
Product: AII 2000, AII 2000A, AII 2000HC, AII 2000 TruO2 Oxygen Electronics: A-1162 PCB Assembly Main Software Version _______________
Analyzers; AII 2000M Oxygen Monitor
PSR Series Oxygen Sensors Accessories: AII-2000 A / M: CABL-1006 Cable, Coiled Phone Jack
FITN-1112-1 Flow Diverter
Classification: IIb AII-2000 HC: A-3675 Adapter, 5/32” Tube to Sensor
TUBE-1007 1/4” Tubing 7 ft. with Adapter
Directives: Medical Device Directive 93/42/EEC, Annex II as amended
by 2007/47/EC All units: BATT-1008 Battery, 1.5V AA (Qty 2)
P-0187 Manual, Instructions for Use ……… Included ______
Standards & 510(k) K952736 O2 Sensors
Certificates: 510(k) K053407 O2 Analyzers PASS
EN 12598:1999 (ISO 7767: 1997) Oxygen devices for QC Test: LCD display 3-1/2 digits ……………………………………………………. ______
patient breathing mixtures – Safety requirements
Battery symbol displays when battery is low ……………………….. ______
Medical Device Directive 93/42/EEC, Annex II as amended Span adjustment +10-30% FS with 100% oxygen calibration ______
by 2007/47/EC, Certificate 485CE
ISO 9001:2008, Certificate 485 Following calibration with 99-100% oxygen and flushing with
ambient air, oxygen reading as displayed by LCD 20.9% +2% ____
ISO 13485:2003, Cert 485A
Span adjustment +10-30% FS with air calibration ……………….. ______
Medical Device Regulations, F-27/ SOR-98-282 (Canada)
Notified Body: AMTAC Certification Services Limited Following calibration with air (20.9% oxygen) and exposing
to 99-100% oxygen, LCD displays 100% +2% ……………………. ______
Davy Avenue, Knowhill
Milton Keynes MK5 8NL Overall inspection for physical defects ………………………………... ______
United Kingdom
CE mark affixed: February 21, 2006 Options: Item No. Qty
Delivery:
Patrick Prindible, QA Manager
4 5
NEVER operate the device in any manner described below doing so
3 Safety Warnings may compromise the clinical condition or the safety of patients, users
or other persons.
ALWAYS follow the statements below as they are essential to reduc-
ing the risk of use error due to ergonomic features of the device or the If the reading is unstable or a malfunction is suspected.
environment in which the device is intended to be used. After the battery symbol appears in the LCD display.
Only trained personnel who have read, understand and agree to follow Near equipment capable of emitting high levels of electromagnetic radia-
the Instructions for Use should operate the device. tion (EMI) or radio frequency interference (RFI).
Retain the Instructions for Use for future reference. Expose the device; particularly the LCD display or sensor to sources of
Refer service needs to trained authorized personnel. Failure to do so may extreme heat, cold or excessive sunlight beyond the device’s storage tem-
cause the device to fail and void the warranty. perature range, refer to Section 8 for extended periods of time.
Inspect the device and accessories before operating and ensure: (a) In a gas stream with a vacuum greater than 14” water column.
there is no evidence of physical damage; (b) the sensor (particularly the Immerse the device, oxygen sensor or coiled cable in any liquid.
sensing surface) and electrical connections are dry; and, (c) the sensor is
Outside of the parameters specified in Section 8 particularly at flow rates
installed and upstream from any humidifying device for accurate calibra-
tion and oxygen readings. greater than 10 liters per minute - the backpressure generated produces
erroneously high oxygen readings.
Calibrate: (a) with a known source of dry 100% oxygen before using
Calibrate: (a) with 20.9% oxygen or room air with the intent of taking
each day or after 8 hours of continuous use; (b) when the temperature
or pressure of the operating environment changes; (c) if the oxygen oxygen measurements at oxygen levels above 30% oxygen; (b) in a hu-
sensor has been disconnected and reconnected; (d) after the battery or midified gas stream or atmosphere; (c) without allowing a newly installed
oxygen sensor has been replace. sensor to stabilize for 15-20 minutes in ambient air.
Sampling flowing gas: (a) install the flow diverter and the tee-adapter in Attempt to sterilize, autoclave, liquid sterilize, immerse in any liquid or
a vertical position as shown in Section 4.3 and (b) assure there is a tight expose the device or accessories to steam, ethylene oxide or radiation
fit between the flow diverter and tee adapter. sterilization.
Sampling static, ambient or controlled atmospheres such as incubators, In the presence of flammable anesthetic gases.
oxygen hoods, tents, etc.: remove the flow diverter. Open the main compartment of the device, except to change the integral
oxygen sensor of the AII-2000 HC Oxygen Analyzer.
Clean the device and accessories in accordance with Section 6.1.2.
Open the oxygen sensor or probe the sensing surface, refer to Section 10
Battery replacement Section 6.2: (a) replace the batteries within twenty- in the event the sensor should leak and someone comes in contact with
four (24) hours of the battery symbol appearing on LCD display and (b) the electrolyte from inside the sensor.
calibrate the analyzer after replacing the batteries.
Operate with a cable that appears worn, torn or cracked, or, allow an
Oxygen sensor installation or replacement Section 6.3: allow the new excess length of cable near the patient’s head or neck; secure it to the bed
sensor to stabilize for 15-20 minutes in ambient air before attempting to rail or other suitable object to avoid the possibility of strangulation.
calibrate.
Allow the device or oxygen sensor to be serviced, repaired or altered by
Store the device by turning the power OFF and removing the batteries if anyone except trained personnel – failure to do so may endanger the
the device will not be operated for over thirty (30) days. patient or damage the device rendering the warranty null and void.
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.
6 7
4.2 Install Batteries
4 Start-Up All devices are powered by two 1.5V AA alkaline batteries which must be in-
stalled before the device can be operated.
4.1 Contents of Shipping Container:
The battery compartment is located at the rear of all devices. Initially
4.1.1 AII 2000 A Oxygen Analyzer, and AII 2000 M Oxygen Monitor: this procedure can be somewhat difficult. Care should be taken not to
ENCL-1061 V-mount retainer (attached) damage the case when removing the battery compartment cover.
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
AND
OR
4.2.1 Procedure:
1. Remove the device and the (2) AA 1.5V Alkaline batteries from the foam
shipping container.
4.1.1 AII 2000 HC Oxygen Analyzer, Home Care: 2. Turn the device over so the shortest raised line on the battery compart-
ENCL-1061 V-mount retainer (attached) ment cover is pointing away from you.
ENCL-1066 Tripod wire stand (attached) 3. Lift the tripod wire stand up and away from the case.
AII-11-60-HC Oxygen Sensor (installed inside analyzer) 4. Grasp the case with both hands, use your thumbs press down firmly on
BATT-1008 Battery, AA 1.5V Alkaline (Qty 2) the raised lines and push the battery compartment cover away from you.
TUBE-1007 Tubing, 1/4” Tubing 7 ft. with Adapter 5. Locate the positive (+) and negative (-) terminals on the battery.
P-1087 Instructions for Use 6. Assure the battery contacts are clean.
7. Align one battery’s positive (+) terminal with the corresponding (+) bat-
tery symbol molded into the case.
8. Insert the battery into the compartment.
9. Repeat with the remaining battery.
AND 10. Replace the battery compartment cover, make sure it snaps into position
and is secured flush against the case. Replace the wire stand as required.
Replace the batteries within twenty-four (24) hours of the battery sym-
bol appearing on LCD display because batteries decline at different
rates. Calibrate the device after replacing the batteries.
Inspect the box and contents for shipping damage. If the device or
components appear damaged, do not attempt to operate the device -
contact the manufacturer immediately, refer to section 9.
8 9
4.3 Install Oxygen Sensor 4.4 Controls
The device cannot function until the oxygen sensor is installed. Once installed,
allow the sensor to stabilize for 15-20 minutes in ambient air before attempt- 4.4.1 AII 2000 A and AII 2000 HC Oxygen Analyzers
ing to calibrate the device. These analyzers employ a micro-processor that is controlled by five (5)
pushbuttons located on the keypad attached to front cover.
NEVER - Attempt to open, repair or service the oxygen sensor. 1. ON/OFF provides power to the electronics
Refer to Section 3 for hints and warnings concerning the handling and 2. ESCAPE aborts a previous selected option
environmental considerations of the oxygen sensor and the device. 3. ENTER selects a menu option
4. 100% initiates the routine for CALIBRATION with 100% oxygen. The sen-
4.3.1 AII 2000 A Oxygen Analyzer, AII-2000 M Oxygen Monitor: sor must be exposed to 100% oxygen.
1. Remove the contents from the shipping container as shown in section 4.1 5. 21% initiates the routine for CALIBRATION with air or 21% oxygen. The
and check for damage. sensor must be exposed to air or 21% oxygen.
2. The coiled cable uses a common RJ11 phone jack at both ends, making a
bad connection impossible. 4.4.2 AII 2000 M Oxygen Monitor
3. Install the sensor away from any humidifying device to prevent moisture The monitor employs a menu driven micro-processor that is controlled by five
from condensing on the sensing surface and assure accurate calibration (5) pushbuttons located on the keypad attached to front cover.
and oxygen readings. 1. ON/OFF provides power to the electronics
4. Connect one end of the cable to the device in the same manner you 2. MENU accesses the MAIN MENU
would connect a telephone. Simply find and register the male plug at the 3. ENTER selects a menu option, and, enables the user to silence the audible
end of the coiled cable and insert it into the mating female jack on the alarm quickly without having to navigate through the menu(s)
side of the device. 4. DOWN ARROW scrolls down the menu options
5. Connect the other end of the cable to the sensor in the same manner. 5. UP ARROW scrolls up the menu options
6. For diffusion sampling of static, ambient or controlled atmospheres –
incubators, infant hoods, tents, etc., the flow diverter and tee are not Note: The monitor is equipped with visual and audible HIGH and LOW
required as shown above. (minimum set point of 15%) alarms which are controlled through the MAIN
7. For sampling breathing circuits with flowing gas, use the flow diverter MENU and are activated when the oxygen value is 0.1% below the LO alarm
and tee adapter accessories supplied with the device, and, position the set point or 0.1% above the HI alarm set point, refer to section 4.6 below.
sensor vertically for optimum results, as shown right. The flow diverter
avoids stagnation and facilitates the movement of gas to and from the 4.4.3 Instructions and Warnings displayed by LCD
sensing area of the sensor thereby producing a more accurate measure- START-UP TEST – diagnostic tests of the electronics, alarm circuit
ment of the gas stream to be measured. (monitors only), battery voltage and the sensor’s signal output.
8. Install the tee-adapter in the breathing circuit. SERVICE DEVICE – non-sensor failures during the start-up test.
9. Screw the flow diverter to the sensor.
CHECK SAMPLE GAS, CHECK CABLE, CHECK SENSOR – sensor fails the
10. Ensure the o-ring is lightly lubricated for ease of entry and a tight seal
start-up test or becomes disconnected during operation, or if an alarms is
between the flow diverter and tee adapter.
activated (monitor).
11. Insert the assembled flow diverter/sensor into the tee allowing 100%
SAMPLING – oxygen concentration from 0-100% in the sample gas during
oxygen (dry, non-humidified) to flow past the sensor at a rate less than
the normal operation.
10 liters per minute.
BAT LOW – battery voltage is not adequate, replace batteries.
4.3.2 AII 2000 HC Oxygen Analyzer: ALARM SET POINTS, CONDITION (set point reverses color and red LED
When the Home Care version with its integral oxygen sensor is ordered, the indicator turns on) for monitor only.
device is shipped with the sensor installed.
10 11
4.5 Start-Up Test 4.5.2 Sensor Failure
Press the ON/OFF key on the front panel to apply power to the device and Sensor failure can result from multiple causes; the user’s failure to connect a
initiate a complete diagnostic test of all system functions: the electronics, sensor or sensor cable, a defective sensor cable or a sensor with an output
feeds voltage and tests the alarm circuit (monitor only below right) internally, outside specification.
confirms the battery voltage is adequate to power the circuit, and, the sen-
sor’s signal output is within specifications. SENSOR - FAILED LOW is one of the possible unsuccessful START-UP TESTs as
illustrated previously and displays additional warnings as follows.
START-UP TEST START-UP TEST
4.5.2.1 AII 2000 A and AII 2000 HC Oxygen Analyzers
ELECTRONICS - PASS ELECTRONICS - PASS The LCD alternately displays the following until the problem is corrected.
ALARMS - N/A ALARMS - PASS
0.0 %
BATTERY - PASS BATTERY - PASS
SENSOR - PASS SENSOR - PASS CHECK SAMPLE GAS
CHECK CABLE
CHECK SENSOR
Following successful Start-Up Test the devices default to the SAMPLING mode. ALARM ALARM
20.9 % 20.9 %
Corrective action:
1. Expose the sensor to air or a gas containing approximately 20.9% oxygen
2. Connect or replace the cable connecting the sensor to the analyzer
3. Connect or replace the oxygen sensor
SAMPLING SAMPLING
LO 15% HI 50% 4.5.2.2 AII 2000 M Oxygen Monitor
Performs the same routine and requires the same corrective action as the ana-
With the exception of the ALARMS for the AII-2000 M (above left) the tests lyzers above with additional indicators related to the monitor’s alarm feature.
and resulting displays are the same.
Note: Any START-UP TEST failure requires the user to take corrective
action before continuing or attempting to use any device. 0.0 % CHECK SAMPLE GAS
CHECK CABLE
CHECK SENSOR
12 13
4.6 Alarms AII 2000M Oxygen Monitor 4.7 Calibration
The monitor is equipped with user selectable HI and LO alarm set points Electrochemical oxygen sensors generate slightly different signal outputs under
which are displayed at the bottom of the LCD. The default alarm set points identical conditions due to variations in the thickness of the sensing membrane
are 15% LO and 50% HI. The LO alarm set point can be set between 15% and manufacturing process.
and 99% and the HI alarm set point can be set between 16% and 100%.
Simulate the application for optimum accuracy: Review Sections 3
Alarm set points may be adjusted in 1% increments by pressing and holding Safety Warnings and 5.2 Application Considerations before proceeding.
the UP/ DOWN ARROW keys, see below. The ARROW keys are disabled when
the alarm set points are within 1% of each other to prevent the HI alarm from The devices are designed to meet the requirements for both ambient
being set below the LO alarm. The HI alarm may be disabled by attempting to and elevated oxygen measurements but should NEVER be calibrated
select a HI alarm set point above 100% to facilitate flushing patients after with air or 21% oxygen with the intent of taking oxygen measurements
anesthesia. In this mode the LCD continually displays HI OFF. at oxygen levels above 30% oxygen.
The AII-2000 M Oxygen Monitor is equipped with four (4) indicators that acti- Accordingly, the devices may be calibrated with either air (20.9%) or
vate when oxygen concentrations are 0.1% below the LO alarm set point or 100% oxygen which requires the user to make a conscious decision to
0.1% above the HI alarm set point. bypass or skip the recommended 100% oxygen calibration.
1. LCD alternates between the ALARM mode with an oxygen reading 0.0%
and recommendation as illustrated in sections 4.5.2.1 and 4.5.2.2 Set-Up:
2. Alarm value and background alternately reverse color on LCD
3. Red LED below the alarm value lights up and begins flashing
4. Audible alarm begins beeping
14 15
Procedure 7. If the calibration is successful, the display below left appears for
AII 2000 Series Analyzers and Monitor employ the identical calibration routine three (3) seconds before defaulting to the display below right:
and displays but they differ slightly in the way they arrive at the display that
initiates calibration routine. Refer to Set-Up illustration and references above
20.9 %
TO SKIP 100% O2 CAL
for gas connections. PRESS ENTER
Both of the above produce the following display which initiates the
HI 50%
20.9 %
INTRODUCE 100% O2
calibration routine. OBSERVE TREND
PRESS ENTER TO CAL
20.9 %
INTRODUCE AIR/21% OXYGEN
9. Repeat steps #3 through #6 using a certified source of 100% oxygen.
100 %
OBSERVE TREND 10. If the calibration is successful, the display
PRESS ENTER TO CAL at right appears for five (5) seconds before
defaulting to the SAMPLING mode.
3. The above prompt remains on the display until:
a. The operator presses ENTER to proceed or OXYGEN CALIBRATION
b. The ESCAPE key on the AII-2000 A and AII-2000 HC or the MENU key SUCCESSFUL
on the AII-2000 M to abort and return to the SAMPLING mode.
4. Expose the sensor to a known source of fresh ambient air or certified 21% Calibration Fails
(dry, non-humidified) oxygen nitrogen mix but not the oxygen enriched An unsuccessful calibration can be caused by
AIR / 100% O2 CALIBRATION
room air commonly found in hospitals. several problems as displayed at right: FAILED
5. Once a suitable calibration gas is intro-
duced, press ENTER to initiate calibration If after three (3) unsuccessful attempts to - CHECK CAL GAS
20.9 %
as displayed right and disable the key calibrate: review section 7 for possible causes - CHECK CABLE
and corrective action or contact Analytical In- - CHECK SENSOR
pad (to prevent the calibration routine RETRY - PRESS ENTER
from being interrupted). dustries Inc. at 909-392-6900.
6. This display appears for sixty (60) seconds AIR CALIBRATION
to allow the sensor to stabilize before To abort the RETRY press ESCAPE (analyzer) or MENU (monitor). Do
IN PROCESS
the microprocessor takes the final reading. not proceed until the analyzer is calibration successfully.
16 17
4.8 Mounting
Every analyzer and monitor is equipped with a male dove tail bracket and 5 Operation
triangular shaped thick metal wire stand secured to the rear of the enclosure.
5.1 Principle of Operation
The AII 2000 Series Oxygen Analyzers and Monitor utilize an electrochemical
Tripod Wire Stand
galvanic fuel cell type oxygen sensor of the type that is extensively used to
Secured between bumper feet on either side of the battery compartment is a measure oxygen concentrations from 0% to 100% in gas streams. Oxygen, the
triangular shaped thick metal wire stand that is hinged under the dove tail fuel for this electrochemical transducer, diffusing into the sensor through a gas
bracket secured at the opposite end of enclosure.
permeable membrane reacts chemically at the sensing electrode to produce an
electrical current output proportional to the oxygen concentration in the gas
Unsnap the triangular thick metal wire stand from between the bumper feet phase. The sensor has an absolute zero meaning that when no oxygen is pre-
and pull it away from the enclosure to form a tripod which allows the device to sent to be chemically reacted the LCD displays 00.0 oxygen.
sit upright on any flat surface
The sensor’s signal output is linear over the entire range, remains virtually con-
stant over the specified useful life and drops off sharply at the end. The sensor
itself requires no maintenance and is simply replaced at the end of its useful life
like a battery. Inasmuch as the sensor is a transducer in its own right, its ex-
pected 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 calibra-
tion. Other factors that can affect the signal output are described in Section 5.2
Application Considerations and Section 3 Safety Warnings which should be read
before use.
Historically, the expected life of galvanic fuel type sensors has been specified as
“in air (20.9% O2) at 25°C and 760mm Hg”. The actual life of any galvanic fuel
type sensor is inversely affected by changes in the average oxygen concentra-
Dove Tail Bracket tion, temperature and pressure it is exposed to during its useful life. For exam-
The male dove tail bracket is secured to the rear of the enclosure with two ple, the AII-11-60 sensor has a 60 months expected life in air (20.9% oxygen)
screws. The 1” female dove tail pole bracket (HRWR-1075) is an optional ac-
at 25°C and ambient pressure, however, in a 100% oxygen atmosphere the
cessory that is commonly found in medical applications. The v-shaped male expected life is 12.6 months [60mo/(100%/20.9%)].
component simply slides into and out of the pole mounted female section.
AII 2000 Series Oxygen Analyzers and Monitors are battery powered by (2) AA
alkaline batteries and controlled by a state-of-the-art microprocessor. The bat-
teries provide enough power to operate the analyzer continuously for approxi-
mately 1,200 hours. Both devices utilize a membrane type keypad for users to
communicate commands to the microprocessor. The monitor is menu driven to
accommodate the alarm functions. The digital electronics provide features such
as system diagnostics, warning indicators, controls and an alarm capability for
continuous monitoring that enhance both safety and effectiveness. The design
criteria, quality program and performance features ensure reliable and accurate
oxygen measurements.
18 19
5.2 Application Considerations The temperature dependent current signal output is compensated by using a
resistor-thermistor network. With a proper resistor-thermistor network, the
Effect of Anesthetic Agents signal can be compensated to within +5% of the oxygen reading over the 5-
The AII 2000 Series Oxygen Analyzers and Monitors utilize an electrochemical 45°C temperature range. This is the worse case situation when going from one
galvanic fuel cell type sensor, model AII-11-60, that has been characterized by extreme of the operating temperature range to the other. The error will be
its gas permeable sensing membrane that allows the gas to be analyzed to eliminated when the thermistor in the temperature compensation network and
diffuse into the sensor where oxygen can be reacted. The displayed oxygen the electrolyte inside the sensor reach thermal equilibrium in approximately 45-
concentration of all sensors of this design decreases in the presence of anes- 60 minutes.
thesia gases. EN 12598:1999/ISO 7767:1997 (E) established standards for the
maximum error allowable over a given duration. The anesthetic agents listed Erroneous oxygen readings can result if the gases flowing over the
(Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurance) were vapor- sensing area of the sensor are not at ambient temperature. This occurs
ized into a gas stream of 30% oxygen / 70% nitrous oxide. because the sensor is exposed to different temperatures. The sensing
area of the sensor is o-ring sealed in the heated breathing circuit and the tem-
Gas Test Level Decrease in O2 Reading perature compensation network at the rear of the sensor is exposed to ambient
Helium 50%, Balance O2 0% temperature.
Nitrous Oxide 80%, Balance O2 0%
Carbon Dioxide 10%, Balance O2 0% Effect of Pressure
Halothane 4% <-1.5% Electrochemical sensors actually measure the partial pressure, not the percent-
Enflurane 5% <-1.5% age, of oxygen in the gas stream they are exposed to. These sensors are accu-
Isoflurane 5% <-1.5% rate at any pressure provided the pressure is constant and the analyzer has
Sevoflurane 5% <-1.5% been calibrated at the same pressure as the sample gas measured.
Desflurane 15% <-1.5%
For example, when connected to a ventilator circuit, the six (6) second T90
The errors listed were observed after a two (2) hour exposure period. The response time of the AII-11-60 Oxygen Sensor causes the analyzer to display
table above summarizes the performance of the AII 2000 Series electronics an increase in the oxygen reading displayed when in fact the alternating
and AII-11-60 Oxygen Sensor. The above performances all meet or exceed the breathing pressure cycles generated by the ventilator is increasing the total
requirements established by EN 12598:1999/ISO 7767:1997 (E). pressure.
Do not operate any device in the presence of flammable anesthetic The increase in the reading displayed is not related to a change in the oxygen
agents such as Diethal Ether or Cyclpropane. percentage but to the increase in partial pressure (corresponding to the in-
crease in total pressure).
Note: The AII-11-60 Oxygen Sensor has been specifically designed and tested
to be compatible with nitrous oxide. For optimum results, mount the oxygen Calibrate at the temperature and pressure (altitude) at which the ana-
sensor with the sensing area facing down toward the floor and be flushed or lyzer will be operated.
calibrated with 100% oxygen every eight (8) hours.
20 21
Calibrate at the temperature and pressure (altitude) at which the ana- 5.4.1 Flowing Gas Streams (Breathing Circuits)
lyzer will be operated, humidified gases cannot be 100% oxygen. 1. Place the sensing area of the sensor into the gas stream to be analyzed
upstream of any humidification equipment.
2. Assure that the flow rate of the gas stream does not exceed ten (10) liters
Effect of Condensation
per minute. Exceeding ten (10) liters per minute generates backpressure.
Excessive condensation collecting on the sensing area or the electrical connec-
tions at the rear of the sensors can adversely impact the performance of elec- 3. Check the gas stream and particularly the mechanical connection for leaks
trochemical sensors. Condensation blocks the diffusion path of oxygen into the that dilute the gas stream with ambient air.
sensor and can reduce the oxygen reading to 00.0 if the condensation covers 4. Assure there are no restrictions in the circuit downstream of the sensor
the entire sensing area. Condensation on the electrical connections at the rear that could generate backpressure on the sensor.
of the sensor can affect oxygen readings. Remedy either situation by shaking
5. Use the flow diverter supplied with the device along
out the condensation and allowing the sensor to air dry.
with the optional tee adapter and position the sen-
sor vertically for optimum results, as shown right.
Erroneously characterized in many instances as a sensor failure, excessive
The flow diverter avoids stagnation and facilitates
condensation is remedied by gently wiping away the condensation with a soft
the movement of gas to and from the sensing area
cloth or simply allowing the sensor to air dry.
of the sensor thereby producing a more accurate
measurement of the gas stream to be measured.
Effect of Electromagnetic Radiation
Tested over a 26 MHz to 1000 MHz electromagnetic field, the analyzer is sus- 6. Install the tee-adapter in the breathing circuit.
ceptible at all frequencies tested except those between 930 and 990 MHz. 7. Screw the flow diverter to the sensor.
8. Ensure the o-ring is lightly lubricated for ease of
Never operate the analyzer near equipment capable of emitting high
entry and a tight seal between the flow diverter and
levels of electromagnetic radiation. Do not continue to operate the
tee adapter.
analyzer if the reading becomes unstable.
9. Insert the assembled flow diverter/sensor into the tee allowing 100%
oxygen (dry, non-humidified) to flow past the sensor at a rate of 5-8 liters
Calibration
per minute.
Calibrating the analyzer or monitor during normal operation involves
the same precautions and procedures as those described in Sections 10. Once the sensing area of the sensor is exposed to the gas stream allow
4.7 Start-up Calibration with the same cautions to review Sections 3 approximately sixty (60) seconds for the reading to stabilize and observe
Safety Warnings and 5.2 Application Considerations. the reading displayed by the LCD.
22 23
5.4.3 AII 2000HC Oxygen Analyzer (Integral Oxygen Sensor) Initially this procedure can be somewhat difficult. Care should be taken
AII 2000HC with its integral oxygen sensor requires connecting the ¼” tubing not to damage the case when removing the battery compartment cover.
supplied (section 4.2.1 above) with the device to a ¼” hose barb attached to a
pressure regulator controlling a source of gas flowing at less than 10 liters per 6.2.1 Procedure:
minute. 1. Turn the device over so the
shortest raised line on the battery
5.5 Alarms (AII 2000M Oxygen Monitor): compartment cover is pointing
The monitor is equipped with user selectable HI and LO alarm set points which away from you.
are displayed at the bottom of the LCD. Section 4.6 describes the operation
2. Lift the tripod wire stand up and
and procedure for setting the alarms in detail.
away from the case.
3. Grasp the case with both hands
and using your thumbs press
6 Maintenance down firmly on the raised lines and push the battery compartment cover
away from you.
Review Section 3 Safety Warnings and Section 7 Troubleshooting for
4. Locate the positive (+) and negative (-) terminals on the battery.
guidelines on servicing the devices.
5. Assure the battery contacts are clean.
6.1 Serviceability 6. Align one battery’s positive (+) terminal with the corresponding (+) bat-
Do not open the main compartment of the analyzer, as it contains no service- tery symbol molded into the case.
able parts inside. Never attempt to repair the analyzer or sensor by yourself as 7. Insert the battery into the compartment.
you may damage the analyzer which could void the warranty.
8. Repeat with the remaining battery.
6.1.2 Cleaning / Reuse Instructions 9. Replace the battery compartment cover, make sure it snaps into position
Clean the device, oxygen sensor and accessories with a soft cloth dampened and is secured flush against the case. Replace the wire stand as required.
with either water or mild isopropyl alcohol solution (70% isopropyl alcohol 10. Calibrate the device after replacing the batteries.
solution in water), if necessary, before re-use. Allow the components to air-dry
after cleaning. 6.3 Oxygen Sensor Replacement
The design of the electronics is intended for only the Analytical Industries Inc.
Note: The Home Care Kit is not intended for patient use, it is intended solely AII-11-60 or AII-11-60-HC Oxygen Sensors. Use of a different oxygen sensor
for confirming the O2 concentration in Oxygen Concentrators. Accordingly, no may result in an erroneous oxygen reading.
cleaning instructions apply.
NEVER - Open the oxygen sensor or probe the sensing surface, refer
6.2 Battery Replacement to Section 10 in the event the sensor should leak and someone comes
The analyzers and monitor are powered by two AA alkaline batteries with an in contact with the electrolyte from inside the sensor.
approximate life of 1,200 hours. A low battery indicator circuit monitors the
battery supply voltage and sends a signal directly to the LCD when the battery 6.3.1 Procedure AII 2000M and AII 2000A - External Sensor
voltage reaches a preset level that activates the battery symbol in the LCD. 1. Disconnect the cable from the old sensor just as you disconnect a tele-
phone jack from a wall plug.
The batteries are housed in a separate compartment located at the rear of the 2. To connect the new sensor simply find and register the male plug at the
device and are accessible by sliding the removable cover. end of the coiled cable and insert it into the mating female jack at the rear
of the sensor until it mates or snaps into place.
3. Calibrate the device after replacing the oxygen sensor.
24 25
6.3.2 Procedure AII 2000HC - Integral Sensor 12. Once the adapter and old sensor have been removed from the case, hold
1. Tools required: small bladed screwdriver. the label of the sensor, again grasp the square edges of the adaptor and
2. Place the device face down on a flat surface. pull – to separate the old sensor from the adaptor.
3. Remove the two (2) screws from the upper corners of the rear of the 13. Remove the new oxygen sensor from the plastic shipping container.
device. 14. Install the new oxygen sensor by reversing steps 12 through 3.
4. Move the tripod up, remove the battery compartment cover (see Battery 15. Calibrate the device after replacing the oxygen sensor.
Replacement) and remove the two (2) screws located on either side.
5. Pull the rear section up ¼”-½”, turn it over and lay it next to the other
section.
6. Locate the white connector at the end of the four (4) wires running from 7 Troubleshooting
the sensor (the cylinder with the white label) to the top of the PCB.
If the recommended corrective action does not resolve the problem return the
7. With your left for finger and thumb, grasp the sides of the back end of the device to the factory for service.
white connector where it is soldered to the PCB.
8. With your right fore finger and thumb, grasp the sides of the section of
Symptom Corrective Action
the white connector where the four (4) wires from the sensor terminate.
9. Separate the connector - hold the white connector section your left hand
while gently pulling and wiggling the white connector section with your Device appears to be physi- Turn device ON – if it successful passes
right hand until it unlocks. cally damaged START-UP TEST and calibrates – proceed.
Install sensor
LCD display reads 00.0 Check electrical connections
Assure electrical connections are dry
10. The oxygen sensor inserts into an adaptor (identified by a round recess
with a cylindrical hose adapter in the center) that slides into grooves
No response to keypad com- Replace battery
molded into the side of the case.
mand
11. Hold the rear section of the case down, grasp the square edges of the
adaptor, lift up (lift straight up so as not to strip the grooves molded into
the adaptor and case) and remove the adaptor and oxygen sensor as a Cannot turn device OFF Calibration routine in process – escape or
single component. wait until completed
26 27
Symptom Corrective Action Symptom Corrective Action
Reading displayed by LCD Wait 5 minutes and repeat calibration with Reading displayed by LCD Replace sensor
drifts during calibration sensor placed on flat surface (not in your does not change when cali-
hand) bration control is adjusted
Check integrity of gas delivery system
Check sensor’s front o-ring seal
Verify calibration gas in not humidified Reading displayed by LCD is Check sensor connection
Remove moisture covering sensor very low Check cable connection
Replace sensor, repeat calibration Replace sensor
Analyzer reading climbs after Allow the sensor to stabilize for 5 minutes in
calibration in 100% dry oxy- 100% dry oxygen and recalibrate Alarms continuously acti- None – Normal operation, confirm set points
gen when exposed to air vated Abnormal -
20.9% Adjust alarm set points
Remove moisture covering sensor
Check sensor connection
After calibration in 100% dry Check primary oxygen delivery device Check cable connection
oxygen, analyzer reading Replace sensor that is nearing the end of its Check integrity of gas delivery system
drifts more than 2% over 8 useful life Check sensor’s front o-ring seal
hours Verify calibration gas in not humidified
Verify flow rate is 4-5 liters per minute
Replace sensor
Reading displayed by LCD Replace sensor Replace cable
does not change when oxy-
gen level changes
Reading does not stabilize or Relocate analyzer away source of radio fre-
fluctuates erratically quency or electromagnetic radiation emis-
sions. Tested over a 26 MHz to 1000 MHz
electromagnetic field, the analyzer is suscep-
tible at all frequencies tested except those
between 930 and 990 MHz.
Check sensor connection
Check cable connection
Wait 5 minutes and repeat calibration
Replace sensor, repeat calibration
Do not attempt to use the analyzer and
return the analyzer for service.
28 29
Expected Sensor Life
8 Specifications Considers the full range of the sensor’s signal, example 7-13 mV. Most medical
oxygen sensors are configured to meet the published, see opposite page, speci-
Accuracy: +2% of FS range under constant conditions fication which distributes the overall sensor life as follows:
- 60 months Expected Service Life (915,420 oxygen % hours)
Analysis: 0-100% oxygen
- 6 months Recommended Storage Life period (91,542 % oxygen hours)
Area Classification: General purpose - 2 months margin of error
Alarms: Analyzer – none; Monitor - User adjustable HI 16-100%, Therefore, the Recommended Storage life period should not be considered a
LO 15-99%, 120 second alarm silence, HI alarm defeat perishable shelf life. Operating at the specified parameters of oxygen concen-
for flushing patients with 100% O2 tration (air 20.9%), temperature (25⁰C/77⁰F) and pressure (1 atm/bar), the
sensor will operate for approximately 68 months whether in storage or in use.
Calibration: 100% oxygen before using each day or after 8 hours of
continuous use. The purpose of the Storage Life period is to ensure the user derives the Ex-
Compensation: Temperature compensated pected Life of 60 months (915,420 % oxygen hours) and does not lose the
benefit of the warranty.
Connections: (M, A) 1x16mm thread or o-ring diverter; (HC) tubing
Warranty
Controls: Soft touch keypad for ON/OFF and menu function
The 18 month (274,626 % oxygen hours) warranty period (begins with ship-
Dimensions: 3.6 x 5.9 x 1.6”; weight 10 oz. (280 grams) ment from the factory and is limited to the first claim submitted) is based on:
- 60 months Expected Service Life (915,420 % oxygen hours)
Display: 3-1/2 digit backlit LCD 2.5” x 1.5”; resolution 0.1% O2
- Estimated exposure (24/7) to 60-70% oxygen concentration
Flow Sensitivity: None between 0.2 to 10 liters per minute - Marginal of error of 2 months
30 31
9 Warranty 10 Material Safety Data Sheet (MSDS)
Coverage
Under normal operating conditions, the analyzer and sensors are warranted to Product name Electrochemical Galvanic Fuel Cell Oxygen Sensor
be free of defects in materials and workmanship for the period specified in the
current published specifications. To make a warranty claim, you must return the Exposure Sealed device with protective coverings, normally no hazard
item properly packaged and postage prepaid to:
Ingredients Carcinogens - none; Potassium Hydroxide (KOH), Lead (Pb)
Analytical Industries Inc.
Properties Completely soluble in H2O; evaporation similar to H2O
2855 Metropolitan Place
Pomona, Ca 91767 USA Flash Points Not applicable, non-flammable
T: 909-392-6900, F: 909-392-3665
E: sales-medical@aii1.com, W: www.aii1.com Reactivity Stable; avoid strong acids, emits fumes when heated
Analytical Industries in their sole discretion shall determine the nature of the Health Hazard KOH entry via ingestion - harmful or fatal if swallowed;
defect. If the item is determined to be eligible for warranty we will repair it or, eye - corrosive, possible loss of vision;
at our option, replace it at no charge to you. If we choose to repair your item, skin contact - corrosive, possible chemical burn.
we may use new or reconditioned replacement parts of the same or upgraded Liquid inhalation is unlikely.
design. This is the only warranty we will give and it sets forth all our responsi- Lead - known to cause birth defects, contact unlikely
bilities, there are no other express or implied warranties. Symptoms Eye contact - burning sensation; skin contact - slick feeling
The warranty begins with the date of shipment from Analytical Industries Inc., Protection Ventilation - none; eye - safety glasses; hands - gloves
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 Precautions Do not remove Teflon and PCB coverings; do not probe with
extend to more than one customer or beyond the warranty period under any sharp objects; avoid contact with eyes, skin and clothing.
conditions.
Action KOH Use rubber gloves, safety glasses and H2O and flush all
Exclusions Leak surfaces repeatedly with liberal amounts of H2O
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 10.1 Disposal
other failure to follow the Owner’s Manual. Oxygen sensors and batteries should be disposed of in accordance with local
regulations for batteries.
Limitations
Analytical Industries Inc. shall not liable for losses or damages of any kind; loss WEEE regulations prohibit electronic products including the He-
of use of the analyzer; incidental or consequential losses or damages; damages lium and environmental sensors from being placed in household
resulting from alterations, misuse, abuse, lack of proper maintenance; unau- trash bins.
thorized repair or modification of the analyzer.
Electronic products should be disposed of in accordance with local
Service regulations.
Contact us between 8:00am and 5:00pm PST Monday thru Thursday or before
12:00pm on Friday. Trained technicians will assist you in diagnosing the prob-
lem and determining the appropriate course of action.
32 33