Table of Contents
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Table of Contents
Related Manuals for RHYTHM P2
Summary of Contents for RHYTHM P2
- Page 1 ITEM# P2 P2 PORTABLE OXYGEN CONCENTRATOR...
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Page 2: Table Of Contents
General Precautions....................6 Ⅱ. DESCRIPTION OF THE P2 OXYGEN CONCENTRATOR ........1 0 Components of the P2 Oxygen Concentrator............10 User Interface Instruction and Symbols used on P2 ..........11 Alerts ........................15 Alerts Table ......................16 Power Supply ......................19 Accessories...................... - Page 3 Symbol Meaning This warning label indicates that the personal safety of the WARNING patient may be at risk. Disregarding a warning could result in significant injury. CAUTION This caution label indicates a precaution or service procedure that must be followed. Disregarding a caution could lead to a minor injury or damage to equipment.
- Page 4 Symbol Meaning Class II (Double Insulated) See instructions for use. Manufacturer Authorized representative in the European Community. Device is protected against water spray <15 degrees from vertical. Date of manufacture Serial number This side up Fragile Storage humidity (Non-condensing) Storage temperature MR unsafe (should not enter MRI scanning rooms) Conforms to all applicable FAA requirements for POC storage and use onboard aircrafts.
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Page 5: Ⅰ. Intended Use, Contraindications And General Precautions
It supplies a high concentration of oxygen and is used with a nasal cannula to supply oxygen from the concentrator to the patient. The P2 is a small and portable device that can be used at home and can be taken with you while performing your daily activities. -
Page 6: Contraindications
Do not submerge the P2 POC or any of its accessories in liquid. Do WARNING not expose to water. Do not operate in the rain. Exposure to moisture can lead to electrical shock and/or damage. - Page 7 ● Must use only the parts and accessories that were provided by the manufacturer, and those that were used while your personalized settings were configured. The settings of the P2 might not correspond with a continuous WARNING flow of oxygen.
- Page 8 Always turn off the oxygen concentrator when not in use. To ensure proper function and avoid the risk of fire and injury: ● Use only with P2 AC power supply WARNING ● Use only with P2 batteries ● Use only approved P2 accessories...
- Page 9 Intended Use, Contraindications and General Precautions General Precautions---Continued Operating the device while exceeding the specified values WARNING for voltage, breath rate, temperature, humidity and/or altitude may decrease oxygen concentration levels. Do not modify this system or equipment in any way. WARNING Modifications could result in hazards to the user.
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Page 10: Ⅱ. Description Of The P2 Oxygen Concentrator
Description of the P2 Oxygen Concentrator Ⅱ. DESCRIPTION OF THE P2 OXYGEN CONCENTRATOR Components of the P2 Oxygen Concentrator... -
Page 11: User Interface Instruction And Symbols Used On P2
Description of the P2 Oxygen Concentrator User Interface Instruction and Symbols used on P2 User Display Panel: Symbol Item Description Press once to turn ON ON / OFF Button Press and hold for one second to turn OFF Press once to toggle between audible and silent mode. - Page 12 Description of the P2 Oxygen Concentrator The home screen will display the icons as in the example below: The icons on the display panel are described as follows: Icon Description Current flow setting (range is from 1 to 5) Battery charge level: ●...
- Page 13 Description of the P2 Oxygen Concentrator Icon Description Powered by AC 1. Device is powered by battery without AC charger connected. 2. Battery level percentage and time remaining (in hours:minutes). 3. Device is ON. 1. Battery is charging. 2. Battery level percentage and estimated time to fully charge the battery.
- Page 14 Description of the P2 Oxygen Concentrator Alert in Audible Mode: The display below shows that the device has detected an active alarm while in Audible Mode (example below shows "Absence of Breath"): Alert in Silent Mode: The display below shows that the device has detected an active alarm while in Silent...
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Page 15: Alerts
Description of the P2 Oxygen Concentrator Alerts Adapter plug/unplug: An adapter icon displays when adapter is plugged in and disappears when unplugged. An audible alarm (if enabled) will also be heard. Battery plug/unplug A battery icon displays when battery is connected and disappears when disconnected. -
Page 16: Alerts Table
Description of the P2 Oxygen Concentrator Alerts Table Alarm item Alarm condition System process Screen Display Battery cycles > 500 Battery is Battery or battery health < Alarm only exhausted. Exhausted Replace battery Replace Sieve Replace Sieve Sieve bed expired or... - Page 17 Description of the P2 Oxygen Concentrator Alarm item Alarm condition System process Screen Display Oxygen Sensor Oxygen Sensor Auto-shut down failed Oxygen Sensor failed Fail after 30 seconds Please contact provider Gas Delivery No delivery detected Auto-shut down failed Gas Delivery Fail...
- Page 18 Description of the P2 Oxygen Concentrator System Alarm item Alarm condition Screen Display process System too cold Auto-shut down System temperature < for Operation System Cold after 10 0℃ or 32°F Shut down, move seconds to warmer place Battery too cold Auto-shut down Battery temperature <...
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Page 19: Power Supply
Standard Lithium Ion Battery - part # BA-P200 The P2 is powered by a standard lithium ion battery. When fully charged, the battery can last for up to 4 hours of operation. The battery is recharged by AC power when it's installed in the P2 and the power supply is connected. -
Page 20: Accessories
The nasal cannula is designed for disposable use. CAUTION Select only CE-marked replacement nasal cannulas (e.g. Runmai NOC-DAW0721) Carry Bag - part # CB-P200 The P2 carry bag makes it convenient to go out for your daily activities: Accessories List Item Part # Nasal Cannula... -
Page 21: Ⅲ. Operating Instructions
Be sure to keep the intake and exhaust areas of the device clear of obstructions to allow for proper air flow. Find a location for the P2 such that auditory alarms can be heard. Turn off device when not in use. - Page 22 Slide the battery into place until the latch returns to the upper position. There will be an audible sound when the battery is in position. Connect AC power to P2 The green LED on the power adapter will turn on and there will be an audible sound when power is connected.
- Page 23 Operating Instructions Connect the nasal cannula to the nozzle fitting The nozzle fitting is located on the top of the P2 near the pre-filter. Connect a nasal cannula to the nozzle fitting on the device Ensure that the cannula is routed to prevent it from being CAUTION pinched or kinked to avoid a disruption of oxygen flow.
- Page 24 Set to the flow rate prescribed by your physician or clinician Press the + or – buttons to adjust the P2 to the desired flow rate. The current setting can be viewed on the display and ranges from 1 to 5.
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Page 25: Ⅳ. Troubleshooting
Troubleshooting Ⅳ. TROUBLESHOOTING The table below lists some common problems and actions you can take. If you can’t resolve a problem, please contact your equipment provider. Problem Possible Cause Recommended Solution Battery is not Remove the battery and re-install it installed correctly correctly. -
Page 26: Ⅴ. Maintenance And Cleaning Of P2
Maintenance and Cleaning of P2 Ⅴ. MAINTENANCE AND CLEANING OF P2 Cleaning the Case The outside case should be cleaned using a cloth dampened with a solution of mild detergent and water. Do not allow liquids into any of the controls, the interior of CAUTION the case, or the oxygen tubing connector. -
Page 27: Battery Care And Maintenance
If batteries become wet, stop use immediately and dispose of battery properly. Battery Replacement 1.Press down the latch, and slide the battery out. 2.Insert the new P2 battery by sliding battery into place until the latch returns to the upper position. - Page 28 75°F (24°C) when batteries are being charged. Battery Time Remaining Clock The P2 continuously displays battery time remaining. This displayed time is only an estimate and the actual time remaining may vary from this value: Store battery in a cool, dry place. Store with a charge of CAUTION 40-50%.
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Page 29: Disposal Of Equipment And Accessories
Maintenance and Cleaning of P2 Disposal of Equipment and Accessories Follow your local governing ordinances for proper disposal and recycling of the P2 accessories. The battery contains lithium ion cells and should be recycled and must not be incinerated. Maintenance Items List Item Model No. -
Page 30: Ⅵ. System Specifications
System Specifications Ⅵ. SYSTEM SPECIFICATIONS Concentrator Specifications Dimensions L/W/H: 8.70in (22.1cm) / 3.35in (8.5cm ) / 6.30in (16.0cm) Weight 4.37 pounds / 1.98Kg (with battery installed) User Interface 2.8 inch LCD color display screen Sound Level 49 dB(A) (on setting 2) Warm-Up time 2 minutes Oxygen... -
Page 31: Classifications
System Specifications Concentrator Specification--Continued Power: AC Power supply AC Input: 100 to 240VAC 50 to 60 Hz Rechargeable Battery Voltage: 14.4VDC Rated capacity:6.8Ah Up to 5 hours Battery Duration Battery Charging Time Not more than 4 hours Temperature: 41 to 104˚F (5 to 40˚C) Environmental Ranges Humidity: 10% to 90%, non-condensing... -
Page 32: Standards Compliance
System Specifications Standards Compliance The device is designed to conform to the following standards: - IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEC 60601 - 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - AAMI ES60601-1 - Medical electrical equipment - Part 1: General requirements for... -
Page 33: Emc Information
System Specifications EMC Information The device has been designed to meet EMC standards throughout its Service Life. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity: The concentrator is intended for use in the electromagnetic environment specified below. The user of the concentrator should make sure it is used in such an environment. - Page 34 System Specifications EMC Information---Continued IEC 60601 Test Electromagnetic Immunity Test Compliance Level Level Environment - Guidance Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications equipment IEC 61000-4-6 150 kHz to 80 150 kHz to 80 should not be used near any part of the device, including cables.
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Page 35: Ⅶ. Warranty
This warranty does not cover damage to P2 or injury to personal property or persons caused by accident, misuse, abuse, negligence, or failure to install in accordance with the... - Page 36 EC REP WellKang Ltd ( www.CE-marking.eu ) Enterprise Hub, NW Business Complex 1 Beraghmore Road Derry, BT48 8SE Northern Ireland, UK Rhythm Healthcare, LLC 3200 Tyrone Blvd N St. Petersburg, FL 33710 Email: contactus rhythmhc.com Website: www.rhythmhc.com V3: 11/11/21...