Analytical Industries Inc. AII-2000 Series Manual

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Technical Specifications

Accuracy:

Analysis:

Application:

Approvals:

Area Classification:

Alarms:

Calibration:

Compensation:

Connections:

Controls:

Dimensions:

Display:

Flow Sensitivity:

Humidity:

LED Indicators:

Linearity:

Pressure:

Power:

Response Time:

Sensitivity:

Sensor:

Sensor Life:

Signal Output:

Storage Temp.:

Temp. Range:

Warm-up Time:

Warranty:

Optional Equipment

FITN-1009 Tee Adapter

HRWR-1075 Dovetail Pole/Shelf Clamp

CC-1072 Carrying Case

2855 Metropolitan Place, Pomona, CA 91767 USA ♦ Tel: 909-392-6900, Fax: 909-392-3665, www.aii1.com, e-mail: info@aii1.com

nbn Austria GmbH

Less than +2% of FS range under constant conditions

0-100% oxygen

Anesthesia

Respiratory Therapy - Ventilators, Respirators

Neonatal & Pediatric Incubators & Hoods

Oxygen Therapy - Intensive Care

Emergency Transport

ISO 9001:2000, MDD 93/42/Annex II, ISO 13485:2003

General purpose

None

Air or certified 100% O

every 8 hours; time - 90 seconds

Temperature compensated

1x16 mm thread or push-in flow diverter with o-ring seal

Soft touch keypad for ON/OFF and menu function

3.6 x 5.9 x 1.6"; weight 10 oz. (280 grams)

3-1/2 digit backlit LCD 2.75 x 1.375; resolution 0.1% O

None between 0.2 to 10 liters per minute

Non-condensing 0-95% RH

None

Greater than + 0.995% under constant conditions

Inlet - ambient; vent - atmospheric

2 AA Alkaline batteries; 1,200 hours continuous use

90% of final FS reading in 9 seconds

Less than 0.5% of FS range

AII-11-60 (A/M models) or AII-11-60-HC (HC model)

60 months in air at 25ºC and 1 atmosphere

None

0º to 45ºC (32 to 113ºF) on intermittent basis

5º to 45ºC (41 to 113ºF)

None

24 months analyzer; 18 months sensor (any application)

AII-2000 A

Oxygen Analyzer

AII-2000 HC

Oxygen Analyzer

Rev 2/15

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Summary of Contents for Analytical Industries Inc. AII-2000 Series

Page 1 Technical Specifications Accuracy: Less than +2% of FS range under constant conditions Analysis: 0-100% oxygen Application: Anesthesia Respiratory Therapy - Ventilators, Respirators Neonatal & Pediatric Incubators & Hoods Oxygen Therapy - Intensive Care Emergency Transport Approvals: ISO 9001:2000, MDD 93/42/Annex II, ISO 13485:2003 Area Classification: General purpose Alarms:...
Page 2 Technical Specifications Accuracy: Less than +2% of FS range under constant conditions Analysis: 0-100% oxygen Application: Anesthesia Respiratory Therapy - Ventilators, Respirators Neonatal & Pediatric Incubators & Hoods Oxygen Therapy - Intensive Care Emergency Transport Approvals: ISO 9001:2000, MDD 93/42/Annex II, ISO 13485:2003 Area Classification: General purpose Alarms:...
Page 3 510(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.
Page 4: Table Of Contents
Table of Contents 1 Introduction Congratulations on your purchase, these Instructions for Use describe the pre- Introduction cautions, set-up, operation, maintenance and specifications of the AII 2000 1.1 Indications for Use Series Oxygen Analyzers & Monitors. 1.2 Intended Use 1.3 Device Description This symbol means CAUTION –...
Page 5: Intended Use
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 .
Page 6: Declaration Of Conformity
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.
Page 7: Safety Warnings
3 Safety Warnings NEVER operate the device in any manner described below doing so 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- If the reading is unstable or a malfunction is suspected. ing the risk of use error due to ergonomic features of the device or the environment in which the device is intended to be used.
Page 8: Start-Up
4 Start-Up 4.2 Install Batteries 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.
Page 9: Install Oxygen Sensor
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.
Page 10: Start-Up Test
4.5 Start-Up Test 4.5.2 Sensor Failure Sensor failure can result from multiple causes; the user’s failure to connect a Press the ON/OFF key on the front panel to apply power to the device and sensor or sensor cable, a defective sensor cable or a sensor with an output initiate a complete diagnostic test of all system functions: the electronics, outside specification.
Page 11: Alarms Aii 2000M Oxygen Monitor
4.7 Calibration 4.6 Alarms AII 2000M Oxygen Monitor Electrochemical oxygen sensors generate slightly different signal outputs under The monitor is equipped with user selectable HI and LO alarm set points identical conditions due to variations in the thickness of the sensing membrane which are displayed at the bottom of the LCD.
Page 12 7. If the calibration is successful, the display below left appears for Procedure three (3) seconds before defaulting to the display below right: AII 2000 Series Analyzers and Monitor employ the identical calibration routine and displays but they differ slightly in the way they arrive at the display that initiates calibration routine.
Page 13: Mounting
5 Operation 4.8 Mounting Every analyzer and monitor is equipped with a male dove tail bracket and 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...
Page 14: Application Considerations
The temperature dependent current signal output is compensated by using a 5.2 Application Considerations 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- 45°C temperature range.
Page 15: Calibration
5.4.1 Flowing Gas Streams (Breathing Circuits) Calibrate at the temperature and pressure (altitude) at which the ana- lyzer will be operated, humidified gases cannot be 100% oxygen. Place the sensing area of the sensor into the gas stream to be analyzed upstream of any humidification equipment.
Page 16: Maintenance
Initially this procedure can be somewhat difficult. Care should be taken 5.4.3 AII 2000HC Oxygen Analyzer (Integral Oxygen Sensor) not to damage the case when removing the battery compartment cover. AII 2000HC with its integral oxygen sensor requires connecting the ¼” tubing supplied (section 4.2.1 above) with the device to a ¼”...
Page 17: Troubleshooting
6.3.2 Procedure AII 2000HC - Integral Sensor 12. Once the adapter and old sensor have been removed from the case, hold the label of the sensor, again grasp the square edges of the adaptor and Tools required: small bladed screwdriver. pull –...
Page 18 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...
Page 19: Specifications
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...
Page 20: Warranty
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 Exposure Sealed device with protective coverings, normally no hazard current published specifications.
Page 21 Aufgrund laufender Weiterentwicklungen sind Änderungen der Spezifikationen vorbehalten. Alle Angaben vorbehaltlich Satz- und Druckfehler. nbn Austria GmbH Riesstraße 146, 8010 Graz +43 316 40 28 05 info @ nbn. at | www.nbn.at...

This manual is also suitable for:

Aii-2000 m Aii-2000 a Aii-2000 hc