Parker Matrx Digital MDM Instructions For Use Manual
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- Installation manual (28 pages) ,
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Summary of Contents for Parker Matrx Digital MDM
- Page 1 Parker Hannifin Corporation 245 Township Line Road Hatfield, PA 19440 USA Office 215-723-4000 ® Matrx Digital MDM Nitrous Oxide/Oxygen Sedation Flowmeter Instructions for Use and Installation Guide 10545100-ENG Rev. D www.porterinstrument.com 18MAR2025...
- Page 2 Representation Legal Manufacturer Parker Hannifin Corporation Precision Fluidics Division 245 Township Line Road Hatfield, PA 19440 USA Office: (215) 723-4000 European EMERGO Europe Communities Westervoortsedijk 60 Authorized 6827 AT Arnhem, The Netherlands Representative Tel: +31 70 345 8570 Compliance with conformity assessment on Conformité...
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Page 3: Table Of Contents
READ INSTRUCTIONS FOR USE COMPLETELY BEFORE OPERATING THIS DEVICE This document contains warnings, cautions, instructions for use, and maintenance information that the user must completely comprehend before using this device. Failure to properly operate and maintain this device may result in patient/user harm and/or damage to equipment. Table Of Contents 1. -
Page 4: Device Information
1. Device Information 1.1. Intended Use/Intended Purpose The Digital MDM Flowmeter is intended for use as a continuous flow system to deliver a mixture of nitrous oxide and oxygen gases to a conscious, spontaneously breathing patient. 1.2. Models The Digital MDM Flowmeter is available in 11 flowmeter models and 14 flowmeters and bag-tee models (described below). -
Page 5: User Interface
Accessories Model Number Model Description 2045-3CA E-Stand, White Hose 2045-3ISO* E-Stand, Tall with Gas Supply Hoses *Denoted as CE Certified and available on European Market. Other models may be available on other international markets. WARNING: The device has been validated with the above accessories. The use of alternatives could result in an unacceptable risk. -
Page 6: Use Of The Device
1.5. Use of the Device The Digital MDM Flowmeter is to be used by a healthcare professional trained in the use and administration of N O and O gases. The device is designed for use in a gas delivery and scavenging system for pain management and / or minimal conscious sedation, which is ideal for short, minimally invasive procedures to alleviate patient anxiety or minor pain and discomfort. -
Page 7: Warnings And Cautions
1.7. Warnings and Cautions Warnings and cautions are listed where relevant to a certain section of this document. A WARNING is an instruction, procedure, or explanation of hazards that may result in injury. A CAUTION is an instruction, procedure, or explanation of hazards that may result in damage to a product, equipment, or the environment. -
Page 8: Delivery Protocols
WARNING: The Digital MDM Flowmeter is not intended to be used during an MR exam and has not been evaluated for safety and compatibility in the MR environment. The safety of the Digital MDM Flowmeter in the MR environment is unknown, but due to the presence of materials in the device that may be ferromagnetic, the Digital MDM Flowmeter should be considered “MR Unsafe”... -
Page 9: Specifications
1.11. Specifications Dimensions Weight 8.0 in W x 5.5 in H x 10.0 in D 6 lbs. (2.72 kg) (20.32 cm W x 13.97 cm H x 25.40 cm D) Mixture Settings Delivery Flow Rate O: 0% - (50%/60%/70%) (model based) : 1.0 - 9.9 LPM : (30%/40%/50%) - 100% (model based) O: 0 - 10 LPM... -
Page 10: Installation Instructions
2. Installation Instructions WARNING: For centrally piped facilities, properly connected gas pipelines are essential to patient safety. The ultimate responsibility of assuring that lines are not crossed rests with the user. Per NFPA 99, the certified medical gas plumber, and verifier, should provide written documentation that all gas pipelines are connected properly and that all use points of the system have been tested prior to use. -
Page 11: Connecting Supply Lines
2-Cylinder Mobile Cart, E-Stand, and Mobile Stand Hold the Digital MDM Flowmeter so that the mounting hole (1) is above the mounting thread (2) of the Mounting Stand. Thread stud into 5/8 - 18 threaded hole (3) on bottom of the outlet housing until nut is reached. Note: If you are attaching to a 2-Cylinder Mobile Cart, take the extra step to tighten the set screw in the collar of the 2-Cylinder Mobile Cart to keep the flowmeter... -
Page 12: Instructions For Use
Optional Matrx Directional “Y” Valve Connection Verify that the sealing O-ring is in place. Place directional “Y” valve adapter (1) over the patient connector port of the Digital MDM Flowmeter. Ensure adapter is fully seated on connector. Attach right angle adaptor (2) to each of the gas outlet connections (3). -
Page 13: Operating Instructions
Ensure the device is securely mounted (as described in Section 2.2 Mounting the Digital MDM) and the gas supply hoses are connected to the correct fittings on the Digital MDM Flowmeter (as described in Section 2.3 Connecting Supply Lines). Ensure the necessary prechecks have been performed, before using the Digital MDM Flowmeter. -
Page 14: Maintenance
When conditions call for the delivery of 100% O a) increase the % O on the flowmeter to 100%. b) If using a directional Y valve, rotate the lever to full-face mask line. c) Control the desired flow of 100% O through the Flow Control buttons. -
Page 15: Pre-Check
4.1. Pre-Check Note: To perform these tests, gas supply cylinders or gas supply shutoff valves are required in order to isolate the gas supply from the device. Attempting to perform these tests with central pipeline supplied gas without a local shut off mechanism is not recommended. Machine Turn-On Test Press the ON/OFF button (1) to turn the flowmeter on. - Page 16 O Failure Test Press Flow Control buttons (1) to set LPM Flow display (2) to 9.9 LPM. Press % O button (3) to set % O display (4) to 30%. Turn off N O gas supply to the flowmeter. When the gas runs out, observe the following: •...
- Page 17 Indicated Percentage (%) Delivery Test Press Flow Control buttons (1) to set the LPM Flow display (2) to 9.9 LPM. Press and hold the % O Control button (2) to decrease the % O display (3) to 30%. The audible alert must sound at the lower limit while the button is held.
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Page 18: Fuse Replacement
4.2. Fuse Replacement Turn flowmeter off by pressing On/Off Button. Unplug the power cord to the flowmeter from wall. Remove power supply cable from power jack (1). Open the fuse compartment (2) Two fuses are required for the unit to operate. Remove each fuse (3) from its clip and replace it with a fuse that meets the specifications listed in Section 1.9 Specifications. -
Page 19: Troubleshooting: Error Codes
4.4. Troubleshooting: Error Codes Error Code Definition Resolution EE01 EEPROM Cannot be read 1. Reset the DMDM by turning off and on. 2. If error remains, discontinue use and contact distributor. EE02 O is leaking 1. Ensure connections on back panel are secure. 2. -
Page 20: Symbols Glossary
6. Symbols Glossary The following symbols may be used throughout this document, as well as on device labels and packaging. Symbol Title of Symbol Description of Symbol Indicates the medical device manufacturer and is accompanied by the name and address of the Manufacturer manufacturer. - Page 21 Symbol Title of Symbol Description of Symbol Indicates the need for the user to consult the instructions important cautionary information such as warnings and precautions that Caution cannot be presented on the medical device itself. [EN ISO 15223-1:2021, clause 5.4.4] Indicates important cautionary or warning information Caution/Warning to the user that is presented in the instructions for use...
- Page 22 Symbol Title of Symbol Description of Symbol Type B Applied Part Indicate a medical device has a type B applied part (Connection for Fresh Gas Tubing and Emergency Outlet Connections) [IEC 60601-1, Table D.1, No. 19] Alternating current Indicates that the instrument is set to measure AC (AC) quantities.
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Page 23: Warranty
Parker Hannifin Corporation. Parker Hannifin Corporation shall not be liable for any damage, injury or loss arising out of the use of the product, whether as a result of a defect in the product or otherwise, if, prior to such damage, injury or loss, the product was (1) damaged or misused;...
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