Analytical Industries AII-2000 M Oxygen Analyzer - Manual (Page 2)

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 Considerations
5.3 Calibration
5.4 Sampling
6 Maintenance
7 Troubleshooting
8 Specifications
9 Warranty
10 Material Safety Data Sheet (MSDS)
6.1 Serviceability
6.2 Battery Replacement
6.3 Oxygen Sensor Replacement
8.1 Spare Parts & Accessories
10.1 Disposal
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1 Introduction
Congratulations on your purchase, these Instructions for Use describe the pre-
cautions, 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, unauthorized repair or improper maintenance of the device.
1.1 Indications for Use
The AII 2000 Series Oxygen Analyzers & Monitor are intended to measure and
display the concentration of oxygen in breathing gas mixtures. The intended
use is only to verify, spot check or continuously monitor, oxygen concentrations
in circumstances where the oxygen concentration is controlled and set by other
medical device such as oxygen/air blenders, flow meters or other control de-
vice.
Users must read the following statements as they are essential to re-
ducing the risk of use error due to ergonomic features of the device or
the environment in which the device is intended to be used.
The devices as identified in Section 1.4 Declaration of Conformity have been
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
or the safety of patients, or safety of the users or other persons.
Federal law restricts this device to sale by or on the order of a physician.
Conformity with essential requirements has been demonstrated by verifying the
performance of the device under normal conditions, bench testing, pre-clinical
and simulated clinical evaluations and determining that undesirable malfunc-
tions 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 accessories to steam, ethylene oxide or radiation sterilization.
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