Related Manuals for Scaleo medical HORIZON P5
Summary of Contents for Scaleo medical HORIZON P5
- Page 1 Portable oxygen concentrator La partie de l'image avec l'ID de relation rId19 n'a pas été trouvé dans le fichier. 0459...
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Page 2: Table Of Contents
Summary SUMMARY ............................2 SAFETY INSTRUCTIONS AND WARNINGS ................ 3 SYMBOLS AND PICTOGRAMS ....................6 GENERAL INFORMATION ABOUT HORIZON ® P5 ............8 ® P5 DESCRIPTION ....................10 HORIZON INSTRUCTIONS FOR USE ......................17 ALERTS AND TROUBLESHOOTING ..................25 CLEANING AND MAINTENANCE ..................34 TECHNICAL SPECIFICATIONS .................... -
Page 3: Safety Instructions And Warnings
Safety instructions and warnings This user manual contains important safety information regarding the use of the Horizon® P5 oxygen concentrator. Please read this manual completely and carefully for a save use of this product. Keep it for future reference. Do not use this product without reading and fully understanding these instructions. - Page 4 It is the patient's responsibility to make further arrangements for the supply of oxygen when traveling; SCALEO Medical assumes no responsibility for those who choose not to follow the manufacturer's recommendations. Horizon® P5 settings do not match those of other brands or models of continuous flow oxygen therapy devices.
- Page 5 It is recommended to have a stress test with your doctor before using Horizon® P5. Do not leave the HORIZON P5 connected to the power supply without its battery. Never leave the Horizon® P5 in an environment which may reach high temperatures. It could damage the device.
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Page 6: Symbols And Pictograms
Symbols and pictograms Symbols used in this manual This symbol indicates instructions and safety information, where an injury may occur if warnings are ignored or partially followed. It is important to carefully follow the advice and warnings. This symbol indicates important information regarding the use of the equipment. Failure to observe this information may result in damage or malfunction of the device. - Page 7 Meaning ON / OFF button Increase Flow Setting Decrease Flow Setting Silent alarm button Device Indentification “HORIZON P5” is a model of product range HORIZON GMN: 3664844HO2PRT Ref. UDI-DI Designation R41 508 3664844000076 Pack Horizon® P5 portable concentrator - 8 cells...
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Page 8: General Information About Horizon ® P5
General information about Horizon ® About Horizon ® The Horizon® P5 is a portable oxygen concentrator that produces highly purified oxygen from ambient air. Oxygen in the air is concentrated using sieves and a pressure swing adsorption process. The patient is the operator of his own machine. - Page 9 Contraindications The device was NOT designed for lifesaving or maintenance of vital functions. Under certain circumstances, the use of non-prescribed oxygen therapy can be dangerous. The device should only be used when prescribed by a physician. Using this device at an altitude above 3000 meters or at a temperature outside the range of 5 to 40˚C or at a relative humidity above 95% without condensation, is likely to have an adverse impact on the flow rate and percentage of oxygen and therefore on the therapy.
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Page 10: Horizon ® P5 Description
Horizon ® P5 description The Horizon® P5 packs come with the following elements: • Horizon® P5 concentrator R41 10 020 • Horizon® P5 Carrying Bag - reference R41 10 070 • Cable and Power Supply - reference R41 10 015 •... - Page 11 Back 6. USB Port 7. Product identification label 8. Power supply input Upper side 9. Cannula nozzle 10. Audible alarm button 11. Alert / alarm LEDs 12. Breathing detection LED 13. On / Off button 14. Screen 15. Flow control DOMU722_v7_EN_20221006_Horizon®...
- Page 12 Main parts description • Particulate filters. Filters must be placed at the inlet of the concentrator during operation to keep the incoming air clean. • USB port. Used only for maintenance. • Power supply input. Allows connection to external power from the AC power supply.
- Page 13 • Breath detection LED. The Horizon® P5 alerts with audible and visual "no breath detected" signals when this mode is activated and no breath has been detected for 15 seconds. After 15 seconds, the device enters automatic heartbeat mode. When another breath is detected, the device switches out of the automatic pulse mode and delivers normally on inspiration.
- Page 14 SCALEO Medical recommends disconnecting the battery from the machine when it is not used for a long period of time. HORIZON P5 batteries must not be stored at extreme temperatures above 60°C or below - 20°C, even for a short time.
- Page 15 • Power cable and power supply. The Horizon® P5 concentrator is powered by an alternating current (AC) source. The Horizon® P5 AC power supply provides the current and voltage required to safely power the Horizon® P5. It is designed to operate from a variety of AC power sources, automatically adjusting to input voltages from 100V to 240V (50-60Hz), allowing it to be used with most power sources in the world.
- Page 16 For assistance with set-up (if needed), operation, maintenance, or to report unexpected operation or events, contact your service provider or SCALEO Medical. The Horizon® P5 and its parts, recommended by SCALEO Medical, are compatible and allow optimal use of the concentrator.
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Page 17: Instructions For Use
Horizon® P5 in the presence of flammable anesthetics, cleaning agents or other chemical vapors. Use of accessories that are incompatible with the Horizon P5 may result in a degradation of performance. Refer to the Accessories section of this manual for more information on the recommended accessories for your concentrator. - Page 18 Horizon® P5. A beep will sound from the concentrator, the display light and control panel LED will turn on and then turn off after a few seconds. A beep will be heard, then the "SCALEO Medical" logo will appear on the screen for 2 seconds. The screen then goes blank.
- Page 19 When the power supply is disconnected from the AC outlet, also disconnect it from the concentrator to avoid unnecessary discharge of the battery. When charging a fully discharged battery, the charging process may start and stop for the first few minutes. The fan will also stop. 4.
- Page 20 To the patient 6. Turn on your Horizon® P5. To turn the device on, press the "On/Off" button. The device will turn on when the "SCALEO Medical" logo appears on the screen and the buzzer beeps. The message "Please wait, starting in progress" will appear when the concentrator starts up.
- Page 21 current setting can be viewed on the display. A short press of the "+" button increases the setting by 0.25 each time. A long press increases the setting in intervals of 1. On the contrary, a short press on the "-" button will decrease the setting by 0.25. A long press will decrease the setting by 1 each time.
- Page 22 The bolus volume of the oxygen concentrator can be adjusted according to the physician's prescription, using the table above. 8. Place the nasal cannula over your face and breathe through your nose. The Horizon® P5 detects the beginning of inhalation and delivers a puff of oxygen at a specific time during inhalation.
- Page 23 To turn off the power, unplug the input cord from its source (i.e., the AC wall outlet) and disconnect it from the Horizon® P5. Oxygen delivery settings are determined individually for each patient with the accessories recommended by SCALEO Medical. Using the Horizon ®...
- Page 24 4. Use your concentrator as usual, following the guidelines previously given in the Instructions for Use section of this manual. Using the Horizon ® P5 while traveling Due to power limitations on airplanes, AC power cannot be used to charge the Horizon® P5 battery when used on an airplane.
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Page 25: Alerts And Troubleshooting
Alerts and Troubleshooting Display Icons The Horizon® P5 screen is divided into three areas: the "Mode" section, the "Power Status" section, and the "Text" section. The "Mode" section is located in the upper left corner of the screen and indicates the operating mode. Mode Battery level The "Power Status"... - Page 26 Icon Meaning Battery is empty. The battery's remaining charge is less than 10%. The battery's remaining charge is approximately 15-25%. The battery's remaining charge is approximately 45% to 50%. The battery's remaining charge is 75% to 80%. The battery is 100% full. The Battery is charging.
- Page 27 Information about the text sections Messages may be displayed in this section. They are intended to guide the user on the status of this device. The following section is devoted to presenting these messages and explaining their meaning. When two conditions occur simultaneously, the condition with the higher priority will be displayed.
- Page 28 The following notification messages are accompanied by a single, short beep. Message Condition / Action / Explanation The SCALEO Medical logo is displayed when the device is turned on. The On/Off button has been pressed for two seconds and the system starts up.
- Page 29 Low Priority Alerts The following low priority alerts are accompanied by a double beep every minute and a solid yellow light. Message Condition / Action / Explanation Battery charge is low, between 5 and 10 %. Low Battery Connect an external power supply or turn off the power and insert a fully Charge Battery charged battery.
- Page 30 Medium Priority Alerts The following medium priority alerts are accompanied by a triple beep, repeated every 30 seconds, and a yellow light flashing at 0.5 Hz. Message Condition / Action / Explanation The concentrator has not detected a breath for 15 seconds. Check that Breathing not detected the cannula is connected to the concentrator, that there are no bends Check cannula...
- Page 31 Message Condition / Action / Explanation Malfunctioning Defective or out of order Solenoid valves. Contact your service provider. pneumatic valves The pressure is above 32 PSI because of the sieves, but the compressor Tank pressure is not overspeeding. If the situation persists for 30 seconds, shut down too high the equipment and contact your service provider.
- Page 32 Message Condition / Action / Explanation Memory error Flash memory failed to read. Contact your service provider. There is no communication with the oxygen sensor. Contact your service Sensor error provider. The fan speed is different from the expected speed. Turn off the Fan error concentrator and do not turn it on until it has been serviced by your service provider.
- Page 33 Problem Possible Cause Recommended solution AC power source is Check the connection to the power supply not properly and verify that the display and control connected. panel lights are on during the connection. Replace the AC power source. Malfunction Contact your service provider. concentrator Connect the power supply to a suitable does not turn on...
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Page 34: Cleaning And Maintenance
Do not remove the safety label. Contact your service provider for situations other than those described in this manual. The tubing, inlet filter and cannula are parts of the gas pathways through the Horizon P5 that are susceptible to contamination by body fluids or exhaled gases. - Page 35 3. Cleaning and replacing the filter The particle filter should be cleaned by the patient on a weekly basis to ensure easy airflow. The particle filter is located on the front of the Horizon® P5, behind the oval center section. The particle filter cover opens and closes with an intuitive clip system.
- Page 36 Patient-to-patient disinfection If used by multiple patients, the same cleaning routine must be performed between each patient, and in addition, a complete disinfection procedure must be performed using a dry hydrogen peroxide mist system and the Horizon® P5 disinfection protocol outlined in the Technical Manual. The disinfection procedure is communicated to providers.
- Page 37 Horizon ® P5 Column Replacement Procedure Use only original columns. The use of unspecified columns may create a safety hazard and/or adversely affect the performance of the device and will void your warranty. The column replacement instructions should only be used when maintenance is required and are not intended for training purposes.
- Page 38 10. Insert the new column into the Horizon® P5 concentrator. Do not leave the column exposed; it must be inserted into the Horizon® P5 as soon as the dust caps have been removed. 11. Push the column into the device so that it is fully inserted into the Horizon® P5 concentrator. The snap lock button should return to the closed position.
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Page 39: Technical Specifications
Technical Specifications Horizon ® P5 technical specifications Dimensions in cm (L x W x H): 21.6 cm 8.8 cm 18.5 cm With single battery: 21.6 cm 8.8 cm 22.0 cm Weight: 2.54 kg (including single battery) Noise level: 44 dB (on setting 2) Heating time: 5 minutes Oxygen concentration*:... - Page 40 Protection degree of the concentrator components IP 22: Protection against vertically falling water drops and against water penetration when solid objects (HORIZON P5 in its bag) used inside the carrying bag: Degree of protection of the outer part of the concentrator...
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Page 41: Electromagnetic Compatibility
Guidelines and manufacturer's declaration - electromagnetic immunity The Horizon® P5 oxygen concentrator is intended for use in the electromagnetic environment specified below. The customer or user of the HORIZON P5 oxygen concentrator should ensure that it is used in such an environment. - Page 42 Voltage dips, short 0 % U commercial or hospital environment. interruptions and 0 % U for 1 cycle If the user of the HORIZON P5 oxygen voltage variations for 1 cycle concentrator requires continuous on power supply 70 % U...
- Page 43 Portable and mobile RF communications equipment should be used no closer to any part of the Horizon® P5 , including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: Disturbances 3V / 0.15MHz - 3 Vrms...
- Page 44 RF compliance level above, the Horizon® P5 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be required, such as reorienting or repositioning the HORIZON P5 oxygen concentrator.
- Page 45 Recommended separation distances between portable and mobile RF communications devices and the Horizon® P5 oxygen concentrator The Horizon® P5 Oxygen Concentrator is intended for use in an electromagnetic environment in which radiated RF interference is controlled. The customer or user of the Horizon® P5 Oxygen Concentrator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Horizon®...
- Page 46 Batteries specification Battery Single Battery 8 cells Dual Battery 16 cells Calls types LI-ion LI-ion Nominal voltage V 14.4 V 14.4 V Max Capacity mAh 6.500 mAh 6.500 mAh x2 Standard current 0.2C 0.2C Max. charging Current 3.0A 3.0A UN38.3 IEC62133-2 Charging temperature 10°C to 45°C...
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Page 47: Warranty & Liability
Liability SCALEO Medical assumes no responsibility for any harm or damage and its consequences directly or indirectly caused to operators, patients or any third party in the following cases: Non-compliance with the instructions and recommendations provided in this user manual. -
Page 48: Product Life & Recycling
Product life & Recycling Product life The Horizon® P5 oxygen concentrator has an expected lifespan of 5 years, with the exception of the batteries, which have an expected lifespanof 500 full charge/discharge cycles. Recycling Dispose of the device in accordance with local regulations on Electronic Waste. WEEE/RoHS recycling directive. -
Page 49: Ec Declaration Of Conformity
EC Declaration of conformity DOMU722_v7_EN_20221006_Horizon® P5 User manual... - Page 50 DOMU722_v7_EN_20221006_Horizon® P5 User manual...
- Page 51 DOMU722_v7_EN_20221006_Horizon® P5 User manual...
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Page 52: How To Contact Us
How to contact us SCALEO Medical ZAC Parc 2000, 107 rue Dassin 34080 Montpellier, France Ph: +33 (0) 4 67 72 94 86 Email: info@scaleomedical.com www.scaleomedical.com 0459 DOMU722_v7_EN_20221006_Horizon® P5 User manual...