Analytical Industries

Oxygen Analysers and Monitors

AII 2000 Series Oxygen Analyser Instructions for Use Oct 2010

Instructions for Use

18 Pages

Table of Contents 1  1 Introduction  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  Operation 5.1 Principle of Operation 5.2 Application Considerations 5.3 Calibration 5.4 Sampling  6  Maintenance 6.1 Serviceability 6.2 Battery Replacement 6.3 Oxygen Sensor Replacement  7  Troubleshooting  8  Specifications  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.  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  Congratulations on your purchase, these Instructions for Use describe the precautions, set-up, operation, maintenance and specifications of the AII 2000 Series Oxygen Analyzers & Monitors.  8.1 Spare Parts & Accessories 9  Warranty  10  Material Safety Data Sheet (MSDS)  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 device. Users must read the following statements as they are essential to reducing 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 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 accessories to steam, ethylene oxide or radiation sterilization.  10.1 Disposal  i  1
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