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- Page 1 Parker Hannifin Corporation Porter 245 Township Line Road Hatfield, PA 19440 USA Office 215-723-4000 Porter Midas™ Flowmeter and eAVS Instructions for Use and Installation Guide FM-1496, Rev. R 25SEP2024 www.PorterInstrument.com/Midas...
- Page 2 Scavenger Screen User Interface ..............................8 Liters Dispends / Gas Remaining Screen User Interface ......................8 1.3.6. 1.3.7. Porter Midas Remote Control Application (Porter Midas App) ....................... 8 1.4. General Description/Principles of Operation ............................9 1.4.1. Midas Flowmeter ..................................9 1.4.2.
- Page 3 1. Device Information 1.1. Intended Use The Midas Flowmeter is intended for use as a continuous flow system to deliver a mixture of nitrous oxide O) and oxygen (O ) gases to a conscious, spontaneously breathing patient. When used with the Electronic Automatic Vacuum Switch (eAVS), the Midas Flowmeter is used to control the scavenging flow rate for exhaled waste analgesic gas.
- Page 4 Accessories Part Number Part Description 2100-NC 2-Cylinder Cart, Nitrous Oxide Regulator and Hoses 2100-ISO-2 2-Cylinder Mobile Cart with Regulator O2, Regulator N2O, and Gas Supply Hoses 2100-ISO-N 2-Cylinder Mobile Cart with Regulator, N2O, and Gas Supply Hose 2045-3 E-Stand, Tall E-Stands 2045-3CA E-Stand, White Hose...
- Page 5 1.3.2. Touchscreen User Interface Description Start Procedure Button Home Screen Button Settings Button Logs Button Liters Dispensed/Gas Remaining Button or N O percentage mixture control (model dependent) Total Flow Setpoint (Liters Per Minute) Stop Button Recovery Scavenger Control Measured Scavenger Flow Rate Measured N O Flow Rate Measured O...
- Page 6 1.3.3. Setting Screen User Interface Description Gas % and Rate a. Starting Flow Rate (LPM) b. Gas % Increment c. Flow Rate Increment d. Maximum N Configuration a. Bluetooth b. Nitrous Pin Activation c. Language d. Change Pin Note: Change Pin Button is only present if pin is active e.
- Page 7 1.3.4. Logs Screen User Interface Description Procedures Log a. Open details b. Close details Note: Procedure Log contains 25 entries. You can swipe up on the touchscreen to view additional procedures. System Log Note: System Log contains 50 entries. You can swipe up on the touchscreen to view additional entries.
- Page 8 1.3.7. Porter Midas Remote Control Application (Porter Midas App) The optional Porter Midas Remote Control Application controls the Midas Flowmeter, and runs on a user- provided, Bluetooth-enabled (BLE 5.2) Apple iPad. Refer to Section 3.5. iPad Configuration and Instructions for instructions on the use of the application.
- Page 9 1.4. General Description/Principles of Operation 1.4.1. Midas Flowmeter The Midas Flowmeter is a gas mixing device that delivers a mixture of N O and O gas to a conscious, spontaneously breathing patient. The device is supplied with regulated compressed N O and O gas.
- Page 10 1.6. Patient Population The patient population includes conscious, spontaneously breathing, awake, alert, and cooperative patients. Patients are selected by a medical professional trained in the use and administration of nitrous oxide and oxygen gases. The medical professional must consider patients who are able to receive the gas mixture based on the risks associated with conscious sedation.
- Page 11 Onboard Diagnostics: The Midas Flowmeter uses onboard diagnostics to conduct self-checks at start-up and during operation. When an issue is detected, a notification will appear in the Notification Display and is accompanied by a continuous, audible alert. An audible notification may be silenced but the visual notification remains on screen until corrected.
- Page 12 Fi or Cellular internet connection to support any of its functionality. The software bill-of-materials (SBOM) for the Midas Flowmeter includes supplier developed software (such as bootloader and drivers) with known cybersecurity information. There are no other Parker Hannifin designed and developed SBOM components. Individual component information and SBOM information can be made available upon request.
- Page 13 1.12.2. Flow Meter Specifications Dimensions: Electrical: Remote Mount Configuration: Midas Power Supply Control Module: Meanwell P/N: GSH60A12-R7BVoltage: 100v – 240v 6.80 in W x 3.86 in H x 7.35 in D (17.27 cm W x 9.80 cm H x 18.67 cm D) Frequency: 50Hz or 60Hz External Power Supply Classification Touchscreen:...
- Page 14 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 15 Porter In-Line Vacuum Control When using a Porter In-Line Vacuum Control, refer to FM-809 (Porter breathing circuit Instructions for Use and Installation Guide) for instructions. Attach hose from the breathing circuit to the mask port (1) of the In-Line Vacuum Control Block. Attach vacuum hose to the vacuum port (2) of the In- Line Vacuum Control Block and other end to vacuum source.
- Page 16 2.5. Mounting the Midas Flowmeter Wall Mount Install 1 Attach Wall Mount Arm to the wall. Place split lock washers (1) over studs and install handles (2). Remove the screws (3) holding the Bag Tee and Optional eAVS from Flowmeter, discard screws Attach Bag Tee and optional eAVS to Flowmeter with the plate (4) in between using the included screws.
- Page 17 Wall Mount Install Lift the Midas Flowmeter and insert the mounting pin (8) into the mounting hole on the top of the Wall Arm Mount (9). Note: Included 2 x bushing (10) must be used stacked together. 2 Cylinder Cart, E-Stand, and Mobile Stand Installs Lift Midas Flowmeter and carefully lower mounting hole (1) on the bottom if the Bag Tee onto mounting thread (2) on the top of the E-Stand/Mobile Stand.
- Page 18 2.6. Under Counter Installation – Remote Models Only Under Counter Mount Installation Instructions Using the template on FM-1511, mark the location and drill holes for screws and cable. Mounting Sheet metal mounting bracket (1) to cabinet face. Run Interface Cable through the cabinet then out to the single connection on rear of Midas Touchscreen (2).
- Page 19 Under Counter Mount Installation Instructions Mount Bag Tee and optional eAVS to one of the slide options below: Mount the under-counter slide to cabinet. Then Mount the Bag Tee (11) and optional eAVS (12) to slide bracket using the included screws (13). Mount the Left or Right Slide into the cabinet.
- Page 20 2.7. Connecting Supply Lines WARNING: Always use clean, dry, medical grade gases, and never oil or grease any part of the device. WARNING: Do not change the connection fitting type or diameter of the supply hoses. The Diameter Indexed Safety System (DISS) is designed to prevent misconnection of N O and O supply lines.
- Page 21 3. Instructions for Use 3.1. Setup WARNING: To minimize the risk of fire or explosion: Always ensure cylinder valves are clear of dust and dirt prior to connection. One method to clear dust and dirt is to briefly “crack” the cylinder valve open to blow out any debris in the line before installing the cylinder.
- Page 22 3.2. Flowmeter Configurations 3.2.1. Gas % and Rate Settings Configuration Press the Settings button (1). The Settings screen appears, push Gas % and Rate to display the Gas % and Rate settings screen. Select the default maximum Nitrous % (2). Note: The absolute maximum allowable gas percentage is factory set.
- Page 23 3.2.2. Configurations Settings Configuration Press the Settings button (1). The Settings screen appears, push Configurations to displaying the Configurations section. Turn on Bluetooth (2) if using the Porter Midas App to monitor and control the Flowmeter using an Apple iPad. See Section 3.5 iPad Configuration and Instructions for setup and operation of the Midas Flowmeter using the Porter Midas App.
- Page 24 3.2.3. Date and Time Settings Configuration Press the Settings button (1). The Settings screen appears, push Time and Date to displaying the Time and Date section. Press Time and Date (1). Select the date format (2). Enter the current date (3). Select the time format (4).
- Page 25 If using the eAVS: a) Press Scavenger button (2). The Scavenger screen appears. b) Press + or – buttons (3) to adjust flow rate in eAVS. The current flow rate is displayed on the screen. Note: Keep the flow rate within the Recommended Rate range shown on the screen.
- Page 26 Press and hold O Recovery button (10) for 1 second to terminate the flow of N O and deliver 100% O at the current flow rate. After 5 minutes, the timer will blink and beep, and will beep every 1 minute thereafter.
- Page 27 3.4. PIN Configuration Setting PIN Push Setting Button (1). Select Configurations (2). Turn on Nitrous PIN Activation (3). Enter a four-digit numeric PIN (4). Push the save button (5). Changing PIN Push Setting Button (1). Select Configurations (2). Push Change PIN Button (3). Enter a four-digit numeric PIN (4).
- Page 28 3.5. iPad Configuration and Instructions Download, install, and configure the optional Porter Midas Remote Control (Porter Midas App) to control and monitor the Flowmeter. The app runs on a user-provided, Bluetooth-enabled Apple iPad only, iPadOS 17 or later. The app is available from the Apple App Store through the provided QR code located on the warranty card.
- Page 29 Different from Flowmeter Screen and iPad Screen Powering the Flowmeter: The Porter Midas App has the ability to power the connected Midas Flowmeter on and off with a power button (1) at the bottom of the screen. Powering the Flowmeter: When a procedure is started, the power button disappears.
- Page 30 The Gas % and Rate Setting screen is only available on the Midas Flowmeter. The following settings can only be set on the flowmeter: Starting Flow Rate PORTER MIDAS REMOTE APP Gas % Increment SCREEN Flow Rate Increment ...
- Page 31 The Midas Flowmeter uses Bluetooth Low Energy (BLE) Version 5.2 to communicate with the Porter Midas Remote App on an Apple iPad. The Porter Midas Remote App can be used to provide a secondary display and set of controls but is not required to run the Midas Flowmeter.
- Page 32 4. Maintenance The Midas Flowmeter and optional eAVS have an expected lifetime of at least 10 years with proper maintenance. The Midas Flowmeter and optional eAVS require proper maintenance, pre-checks, and servicing. It is recommended to return the device to the manufacturer for servicing every 2 years. Following 10 years, the devices may need additional servicing and/or component replacement.
- Page 33 O Failure Check – Confirms notification for no N O flow. Turn the Midas Flowmeter On Press and hold Start button for 1 second Turn the percent mixture to 70% N O or 30% O (model dependant) Turn off N O gas supply to the flowmeter.
- Page 34 eAVS Check – Confirms scavenger functionality. Ensure the eAVS is connected to a vacuum source. Ensure there is no vacuum hose connected from the mask port on the eAVS Refer to Section 2.2 Connecting the Vacuum Controller to identify mask port. Turn the Midas Flowmeter On Press and hold Start button for 1 second Create a seal by placing your hand over the mask port on the eAVS, you should feel suction on...
- Page 35 4.2. Cleaning The Midas Flowmeter and optional eAVS must be cleaned between each use in order to prevent the spread of infections. Cleaning the device has been validated with Super Sani-Cloth Germicidal wipes. WARNING: The following warning applies to the device and any device’s components and accessories: ...
- Page 36 Notification Description Recommended Action Display Communication Unable to communicate with the For remote configuration: Failure Display 1. Verify cable connected between Flowmeter and display. 2. If notification remains, discontinue use of device and contact distributor. If this is NOT a remote configuration: 1.
- Page 37 Store. If the iPad is set to “automatic updates” the app will updated automatically when 8. How do I update the Porter Midas Remote App needed. when a new version is released? If the iPad is not set to “automatic updates”...
- Page 38 Alternatively, the device and its electrical/electronic components may be returned to Parker / Porter for recycling. Electromagnetic Compatibility Information WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas, however, not including cell phones) should be used no closer than 2 meters to any part of the Midas Flowmeter and eAVS.
- Page 39 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 Manufacturer manufacturer Information...
- Page 40 Copyright. The Software and Information are protected by copyright and are owned exclusively by Parker. Nothing in this EULA constitutes a waiver of Parker’s rights under United States or international copyright laws or any other international, federal, or state law. Parker retains all rights not expressly granted under this EULA.
- Page 41 Term. This license and your right to use the Software and Information shall automatically terminate if you fail to comply with any of this EULA. Parker may at any time, without prior cause or notice, and in its sole discretion: (a) modify, update, obsolete, revise, alter, change, withdraw, or cancel the Software and Information or any module or other functionality thereof;...
- Page 42 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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