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Summary of Contents for Apex Digital XT Prime
- Page 1 XT Prime CPAP System Instruction Manual Model No.: 9S-005580 Please read the instruction manual before use.
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Page 2: Table Of Contents
Table of Content Important Safeguards............1 1. Introduction ..............3 2. Product Description ............5 3. Installation ..............6 4. Operation ..............7 5. Adding a Humidifier ............ 11 6. Using the SD Card to Collect Data ......11 7. -
Page 3: Important Safeguards
English IMPORTANT SAFEGUARDS – PLEASE MAKE THIS PRECAUTIONS LIST AVAILABLE TO ALL USERS and PROVIDERS READ ALL INSTRUCTIONS BEFORE USING THIS SYSTEM WARNING – THIS DEVICE IS NOT INTENDED FOR LIFE SUPPORT. It may stop operating due to power interruption but no hazards to patient. If oxygen is used with the device, the oxygen flow must be turned off when the device is not in use. - Page 4 English CAUTION – Make sure the environment around the machine is dry and clean. Dust and foreign particles may affect the treatment. Keep the air inlet on the back of the machine clear to prevent overheating and damage of the device. Do not place the machine near a source of hot or cold air. Extreme cold or hot environment may damage user's respiratory airway.
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Page 5: Introduction
English 1. Introduction This manual is provided to explain initial set up and operating instructions. This manual should be stored in a safe location and be readily accessible for future reference. 1.1 General Information Obstructive Sleep Apnea (OSA) is a condition that an intermitted and repetitive obstruction of the upper respiratory tract causes a complete (apnea) or partial (hypopnea) block of breathing airflow during sleep. - Page 6 English EMC Warning Statement This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2:2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity.
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Page 7: Product Description
English 2. Product Description Components including: (1) Main CPAP device (2) Detachable power cord (3) User manual (4) Flexible air tubing with 1.8 m length (5) Carrying bag (6) SD card and USB cable Note 1: ONLY for Physician or Technician to download data. Patient should not use this unction. -
Page 8: Installation
English 3. Installation 3.1 Unpacking To secure its contents inside, the CPAP device and accessories are bundled in a paper packaged box. Unpack this box by removing the CPAP and its accessory and checking for any damage, which may have occurred during shipping. If there are damages, please contact your dealer immediately. -
Page 9: Operation
English 4. Operation NOTE: Always read the operating instruction before use. 4.1 Control Panel Description Buttons arrangement on control panel and main use of the buttons: START/STANDBY To start the treatment, simply press the "START/STANDBY" button. To stop the treatment, press the "START/STANDBY" button again. The display will switch between [STANDBY] and Therapy Pressure [ XX.X cmH O] in cmH O unit. - Page 10 English 4.2 Function Description Getting Started – First time use. For first-time use, follow the steps below: 1. Make sure that your physician or care provider has initialized and configured the appropriate treatment values into the unit. 2. Make sure that your package contains a face or nasal mask with headgear. If not, your physician or care provider can recommend the type of mask and headgear you must obtain 3.
- Page 11 English Low Pressure Auto Off Press "MENU" button to select [LOW P on/off] menu, you can view if the Low Pressure Auto Off setting is enabled and the device will be automatically turned off while detecting a large leak for 3 minutes. This setting is adjustable only by the provider, a respiratory therapist or physician.
- Page 12 English 4.4 Flowchart of Menu settings Enter the user's menu mode by pressing the “MENU” button. Ramp (Ramp Time) < 0, 5, 10, 15, ……………., 45> min Ramp P (Ramp Starting Pressure) < 3, 3.5, 4, 4.5, ……………., 19> cmH2O (Therapy Pressure) <...
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Page 13: Adding A Humidifier
(9S-006500) instruction manual for complete setup information. NOTE: When XT Prime CPAP device is used with the heated humidifier, its power supply is from the power socket outlet of the heated humidifier. Do not connect the power cord to CPAP device and plug into main electrical outlet. -
Page 14: Cleaning & Maintenance
English 7. Cleaning & Maintenance 7.1 Cleaning the Main Unit The main unit should be cleaned regularly (at least every 30 days). To clean the unit, wipe it down with a damp cloth using a mild detergent. When selecting a cleaning agent, take precautions to choose one that is not chemically abrasive to the surface of the plastic case. -
Page 15: Troubleshooting
English 7.3 Air Filter Maintenance For an optimum operation of the device, the air filter can be cleaned by the user at least once every two weeks or more often if this device is operated in a dusty environment. It is recommended that the filter be replaced with a new one after 6 months of use;... - Page 16 English M e s s a g e t yp e D e f i n i t i o n M e s s a g e i n L C D Error: Error for abnormal system settings Error 001 Primary function can’t execute.
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Page 17: Technical Specifications
English 9. Technical Specifications I t e m S p e c i f i c a t i o n s Power Supply Universal power supply, AC100-240V, 50/60 Hz, 0.5-0.3A Pressure Range 4-20 cmH O (adjustable in 0.5 cmH O increment) Ramp Time 0-45 minutes (adjustable in 5-minute increment) -
Page 18: Note, Caution, And Warning Statements
English Symbols BF symbol, which indicated this product, is according to the degree of protecting against electric shock for type BF equipment. Attention, should read the instructions. Refer to instruction manual Attention, should read the instructions. Class II Protected against solid foreign objects of 12.5 mm and greater; Protected against vertically falling water drops. -
Page 19: Servicing
English 11. Servicing The XT series systems are intended to provide safe and reliable operation according to the instructions provided by Apex Medical. Apex Medical recommends that the XT system be inspected and serviced by authorized technicians if there is any sign of wear or concern with device function. -
Page 20: Appendix A: Emc Information
English Appendix A: EMC Information Guidance and Manufacturer’s Declaration- Electromagnetic Emissions: This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Emissions Test Compliance Electromagnetic Environment-Guidance RF emissions... - Page 21 English Guidance and Manufacturer’s Declaration - Electromagnetic Immunity: This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Immunity Test IEC60601 test level Compliance Electromagnetic Environment-Guidance Portable and mobile RF communications...
- Page 22 English a) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.
- Page 24 APEX MEDICAL USA CORP. 615 N. Berry St. Suite D, Brea, CA 92821, USA APEX MEDICAL S.L. Elcano 9, 6 planta 48008 Bilbao. Vizcaya. Spain APEX MEDICAL CORP. No.9, Min Sheng St., Tu-Cheng, New Taipei City, 23679, Taiwan www.apexbrand.com Print-2012/All rights reserved...
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donde llevo el equipo para que lo revisen