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Parker Matrx Digital MDM User Manual

Parker Matrx Digital MDM
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1 10545100-Australia Rev. 08/2018
Parker Hannifin Corporation
Precision Fluidics Division
Porter Instrument
245 Township Line Road
Hatfield, PA 19440
Office 215 723 4000
Fax 215 723 5106
Digital MDM® Mixer
Operations Manual
This product complies with the Medical Device Directive (93 / 42 / EEC).
A “Declaration of Conformity” in accordance with the directive has been made and is on file.
The Quality System for Porter Instrument is certified to ISO 13485. The scope of our registration is:
“The design, manufacture, distribution and servicing of fluidic components and integrated systems for use in the Medical
Equipment, Diagnostic, Biopharmaceutical, Agent Detection, Analytical Instrumentation and Industrial markets, Nitrous
Oxide Oxygen Sedation Flowmeters, Gas Scavenging Systems and Gas Distribution products for use by a physician,
dentist or licensed healthcare professionals and the distribution of Steam Sterilizers.”
Check our website: www.porterinstrument.com for additional information.

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Parker Matrx Digital MDM Specifications

Pressure and Flow Requirements IconPressure and Flow Requirements
pressure requirements50 to 55 psi
flow requirements10 LPM minimum flow
oxygen inlet pressure requirements50 to 55 psi
oxygen inlet flow requirements30 LPM minimum flow
Environmental IconEnvironmental
storage temperature-10°F to 120°F (-17°C to 48°C)
operating temperature72°F nominal (22°C)
humidityambient, non-condensing
Electrical IconElectrical
domestic input voltage supply115 VAC nominal
domestic input line frequency60Hz
domestic circuit protectiontwo 2.5 amp time delay fuses
international input line frequency50–60Hz
international circuit protectiontwo 2.5 amp time delay fuses
Weight and Dimensions IconWeight and Dimensions
width8 inches
height5.5 inches
depth10 inches
weight6 lbs

Summary

Warnings and Precautions

Electrical Connections & Grounding Instructions

Requirements and Features

Bag Tee (Breathing Bag) Requirements

Requirements for the breathing bag tee and associated components for gas delivery.

Use of Scavenging

Guidelines for utilizing the scavenging system for waste gas management during procedures.

Room Ventilation

Conformance requirements for mechanical ventilation in healthcare facilities.

Facility Piping

User responsibility for verifying correct connection and testing of medical gas pipelines.

Sleeve Index System (SIS)

Explanation of the mechanically indexed system used for gas connections to prevent misconnections.

Alarm Test

User instruction to test the alarm system before each clinical use for proper operation.

Machine Diagnostics

How the unit performs self-checks and indicates detected errors via display codes.

Intended Use: Flowmeter for Analgesia Delivery System

Continuous Flow Systems

Digital MDM Mixer is a continuous flow device for variable gas concentrations and flow rates.

Breathing Circuits

Lists compatible breathing circuits and their essential criteria for use with the device.

Gas Supply Connection

Instructions for connecting gas supply lines to the unit, including pressure requirements and leak testing.

User Responsibility

User's responsibility for proper use, maintenance, repair, and ensuring correct gas supply.

Unit Description and Features

Mixture Control

Precise mixing of oxygen and nitrous oxide from cylinders or pipeline gas systems.

Built-In Safety

A series of alarms alert the user to any problem condition within the unit or gas supply.

Displays and Indicators

Overview of the front panel displays and indicators, including flow and oxygen percentage.

Safety Alarm System

Alarm Conditions

Details the four alarm conditions: Oxygen Failure, Nitrous Failure, 1 LPM Oxygen Limit, Flush Flow Low.

Key Pad Controls

Explanation of the function of each key on the control panel, including On/Off and flow adjustments.

Oxygen Flush

Procedure for delivering 100% oxygen directly to the mixed gas outlet.

Alarm Test/Silence Key

Functionality of the alarm test key for silencing audible alarms and testing system components.

General Installation

Installation of Rubber Goods

Instructions for connecting breathing circuits, bag tee, and scavenger components.

Connection of Oxygen - Nitrous Oxide

Procedure for connecting N2O and O2 supply lines using the Sleeve Indexed System (SIS) fittings.

Installation of Power Cord

Guidance on connecting the power cord and ensuring a protective earth ground connection.

Side Effects & Contraindications

Possible Side Effects of Nitrous Oxide

Lists potential side effects experienced during Nitrous Oxide – Oxygen Conscious Sedation.

Precautions/Relative Contraindications

Lists situations requiring caution or discontinuation of Nitrous Oxide delivery.

Contraindications

Lists conditions or situations where Nitrous Oxide should not be administered.

Development of Delivery Protocols

Patient Population

Guidance on using the gas mixture for conscious, spontaneously breathing adult and pediatric patients.

Continuous Flow

Details on establishing delivery protocols for continuous flow devices and self-administration.

Preparation for Use

Performance Checks

Preliminary tests to ensure the analgesia mixer is performing correctly before use.

Machine Turn-On Test

Procedure to test the unit's initialization routine and default display values upon startup.

Alarm Indicator / Lamp Test

Test to verify all alarm readouts, displays, indicators, and audible alarms function correctly.

Oxygen Failure Test

Test procedure for verifying the Oxygen Failure alarm and associated system responses.

Nitrous Failure Test

Test procedure for verifying the Nitrous Failure alarm and associated system responses.

Indicated Flow Delivery Test

Test to verify the flow rate display accurately reflects adjustments made with flow control keys.

Indicated Percentage (%) Delivery Test

Test to verify the % OXYGEN display accurately reflects adjustments made with % OXYGEN control keys.

Directions for Use

General guidance on strategies to avoid over sedation and maximize patient satisfaction.

Basic Delivery Technique

Explains titration as a method for administering N2O/O2 sedation for comfortable patient states.

Maintenance

Routine Maintenance Procedures

Daily inspection of mixer, hoses, connections and performance tests prior to use.

Cleaning Instructions

Guidelines for cleaning the unit's exterior using a damp cloth and mild soap or cleaner.

Fuse Replacement

Procedure for replacing blown fuses in the 220-240V unit, specifying fuse type and rating.

Specifications

Physical

Details dimensions and weight of the Digital MDM Mixer unit.

Fittings

Lists the types of fittings for gas inlets and the fresh gas outlet.

Environmental

Specifies storage and operating temperature ranges and humidity requirements.

Gas Supply

Details pressure and flow requirements for Oxygen and Nitrous Oxide gas supplies.

Gas Delivery

Specifies oxygen flush rates, concentration ranges, and overall flow ranges for gas mixtures.

Electrical

Provides input line frequency and circuit protection details for the unit.

Performance and Accuracy

Defines the accuracy tolerances for oxygen and nitrous oxide flow rates and percentages.

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