Teledyne manual Applicable Standards, Introduction MX300-I

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Introduction

MX300-I

 

 

 

Options for alternate display configuration). An integral battery life indicator is displayed “on demand” with the MX300-I.

The instrument is powered by three AA alkaline batteries and is designed to operate for 2000 hours in non-alarm state.

Oxygen analysis is linear across the single range of 0-100% using Teledyne’s class R17MED oxygen sensor. A unique sensor failure alarm is incorporated which warns the user if the sensor signal is lost or low. When this occurs, the √ SENSOR display flashes. The alarm buzzer can be silenced by pressing the ALARM SILENCE key. If the alarm condition is not corrected within 115 seconds the alarm buzzer will reactivate.

The MX300-I unit incorporates a dual concentration alarm with individual user-defined set points. The set points are displayed on the lower portion of the LCD display with the low alarm set point appearing at the lower left and the high alarm appearing on the lower right of the display. The alarm circuitry provides both an audible and visual alarm.

1.1 Applicable Standards

The MX300-I units are built to meet or exceed regulatory and industry standards for use as a medical device. The instruments are designed, built and tested with the following applicable standards:

ASTM F 1462: Specifications for Oxygen Analyzers

ASTM F 1463: Specifications for Alarm Signals

ISO 7767: Oxygen Monitors for Monitoring patient Breathing Mixtures

ISO 9703-1: Anesthesia and Respiratory Care Alarm Signals Part 1

ISO 9703-2: Anesthesia and Respiratory Care Alarm Signals Part 2

EN/IEC 60601-1-2: Medical Electrical Equipment—Part 1 General Requirements for Safety. Electromagnetic Compatibility Requirements and Test

MIL-STD-810E: Environmental Test Methods

EN/IEC 60601-1: Medical Electrical Equipment-General Requirements for Safety

Teledyne Analytical Instruments

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Contents MX300-I MX300-I How To Use This Manual About This ManualSafety Messages Table of Contents Appendix List of Figures MX300-I Front ViewList of Tables Introduction MX300-I Front ViewApplicable Standards Introduction MX300-IFeatures OptionsApplications Theory of OperationSignal Processing SensorIntroduction MX300-I Setup OperationSensor Installation or Replacement Installing the R17MED SensorSensor Cable Connection to Monitor V-Mount Adapter Installation MountingBattery Installation Installing BatteriesCalibration Calibration SequencePortable Oxygen Monitor Operation Alarms Setting the AlarmsOutput 0-1 VDC or RS232 0-1 VDC or RS 232 Digital Output Port Procedure UseGas Sampling HumidityTemperature PressureDiscrepancy in Readings Anesthetic GasesOxygen Reading Error in a Mixture of Anesthetic Gas Cleaning Do’s and Don’tsPortable Oxygen Monitor Operation Operation MX300-I Overall Maintenance General Service InformationBattery Maintenance Sensor Maintenance CalibrationAlarms Pressure Troubleshooting Troubleshooting√ Sensor Ventilate the patient, water Error Codes WatchdogOther Problems with the Instrument Return Authorization for Service Specifications AppendixSpare Parts List Optional AccessoriesOrders should be sent to Blank Index CrossoverIndex MX300-I