User Manual MK/YF38-07 – V2.01CS Contents PREFACE .......................... 6 CHAPTER 1 PRODUCT OVERVIEW .................. 7 1.1 I NTENDED PURPOSE PRODUCT USAGE AND APPLICATION ............ 7 1.2 W ORKING PRINCIPLE ...................... 8 1.3 S AFETY TIPS ......................... 8 1.3.1 W ARNING ........................... 8 1.3.2 C AUTIONS ...
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User Manual MK/YF38-07 – V2.01CS CHAPTER 4 EQUIPMENT USE .................... 22 4.1 P .................. 22 START INSPECTION ACHINE 4.2 P .................. 22 START INSPECTION 4.3 S ....................... 23 TARTING TREATMENT 4.4 S TOPPING TREATMENT ....................... 23 4.5 P ATIENT AND CLINICIAN MODES ...
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User Manual MK/YF38-07 – V2.01CS 8.1 R EPAIR AND MAINTENANCE .................... 41 8.2 F REQUENCY ........................ 41 8.3 C ...................... 41 LEANING METHOD 8.3.1 C CPAP ................ 4 1 LEANING OF MACHINE AND HOSE 8.3.2 W ...................... 4 2 ATER TANK CLEANING 8.3.3 A IR FILTER CLEANING AND REPLACEMENT ...
User Manual MK/YF38-07 – V2.01CS Preface is a registered trademark of CPAP Sales Pty Ltd (hereinafter CPAP Sales) Models C2 (CPAP) and C5 (AUTO) are Sleep Apnea Therapy Devices (Non-invasive ventilators) have been independently developed by Micomme Medical Technology Development Co., Ltd (hereinafter referred to as Micomme Medical) exclusively for CPAP Sales.
User Manual MK/YF38-07 – V2.01CS Chapter 1 Product overview 1.1 Intended purpose, product usage and application This Class IIa Medical Device has been registered and approved by the Australian Therapeutic Goods Administration (TGA) for supply by CPAP Sales Pty Ltd. It is a portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnea (OSA);...
User Manual MK/YF38-07 – V2.01CS 1.2 Working principle This CPAP Machine includes a power cord, ac adaptor, hose and Machine (including main control panel, motor, display, control dial, buzzer, enclosure, humidifier, water tank and ozone generator). Room air passes through a filter, and is sent out at a preset pressure and flow rate through the controlled motor and heated humidifier, before reaching the respiratory tract and finally the patient’s lungs.
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User Manual MK/YF38-07 – V2.01CS inlet may be blocked so that the user may get suffocated. Do not try to wear the face mask before the equipment is turned on and works normally; or repeated inspiration of carbon dioxide may be caused. In some case, inspiration of exhaled gas for a few minutes can lead to suffocation.
User Manual MK/YF38-07 – V2.01CS The product must be used as specified in IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Additional equipment connected to medical electrical equipment through the network/data coupling must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment).
User Manual MK/YF38-07 – V2.01CS should be sent to the maintenance staff passing the training organized by Micomme Medical for maintenance every half a year; or the accuracy of the equipment’s pressure output may be affected. All the parameters of the ventilator are stored in non-volatile memory, so disconnection ...
User Manual MK/YF38-07 – V2.01CS 1.3.4 Potential side effects and solutions The non-invasive PAP (positive airway pressure) may have following potential side effects: Dry mouth, nose or throat; Abdominal distension; Discomfort with ear or sinus; Eye irritation; Skin irritation caused by face mask; ...
User Manual MK/YF38-07 – V2.01CS Chapter 2 Appearance and accessories 2.1 About the model The CPAP Machine product is coded as follows: Version Bi-level PAP/CPAP 2.2 Component summary In the unlikely event that any of the following major components or parts are missing, please contact your equipment supplier.
User Manual MK/YF38-07 – V2.01CS 2.3 Components and parts Connection with CPAP Machine hose; 360°rotation; outlet Air outlet dimensions: Outside Diameter 22mm, Inside Diameter 15mm. Including water tank, heating plate and air outlet; can be separated Heated Humidifier from main body of the Machine. Rotate the dial clockwise or counterclockwise to scroll through the screen display;...
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User Manual MK/YF38-07 – V2.01CS Humidifier Press the button in order to remove the humidifier portion from the Separation button Machine. USB Data Port For use with USB memory stick to save sleep therapy usage data. 24VDC Input Socket Connection with power adapter. The foam filter screens out normal household dust and pollen, the Air Filter cover filter cover is designed to keep the filter in place and should not be...
User Manual MK/YF38-07 – V2.01CS 2.4 Notes about terminologies and acronyms You may encounter the following terminologies and acronyms when using the device. Please read carefully before use. Terminology/acronym Definition Pressure unit, cmH2O. Apnea and hypopnea index: the frequency of apnea and hypopnea incidence in each hour.
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User Manual MK/YF38-07 – V2.01CS Component beyond repair by user. It is in line with the rules about recycling and reusing of waste electrical and electronic Machines/limited use of toxic substances in Waste Electrical and Electronic Equipment/Restriction of the Use of Certain Hazardous Substances (WEEE/RoHS) Ramp function.
User Manual MK/YF38-07 – V2.01CS Chapter 3 Installation and operation 3.1 Placement location The CPAP Machine should be placed on a solid and flat table or fixed on support. The user should operate the equipment in a position where it is easy to access the equipment and see clearly the information displayed on it.
User Manual MK/YF38-07 – V2.01CS 3.2.3 Connect the hose to the mask Connect either end of the hose tubing supplied with your equipment to your mask. The mask may have been included as part of a package, or can be purchase separately. Any brand of mask will fit on this hose.
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User Manual MK/YF38-07 – V2.01CS Fully open the humidifier cover lid and slide the water tank out of the main unit. Carefully add distilled water into the water tank. Do not over-fill and do not operate without water, unless the humidifier heating is set to OFF. Slide the water tank back into the humidifier.
User Manual MK/YF38-07 – V2.01CS Close the upper cover of the water tank firmly until the lid clicks into place. 3.2.5 Connect the hose to the Machine Finally, connect the other end of the hose to the swivel connector on top of the humidifier. If required, before use, adjust the humidifier temperature to your personal preference in the [Set] >...
User Manual MK/YF38-07 – V2.01CS Chapter 4 Equipment use Before starting treatment, please check the equipment and accessories to ensure they are intact and free from any damage. 4.1 Pre-start inspection - Machine After the CPAP Machine is properly connected with the power supply, its LCD will show the main startup menu, where treatment parameters can be checked and set.
User Manual MK/YF38-07 – V2.01CS 4.3 Starting treatment When [Treat] is showing on the display, press the control dial button to start the CPAP therapy treatment. The airflow pressure will be displayed on the screen. In the unlikely event of an error occurring, an alert tone will be sound, and a corresponding red alert message will be display at the top left of the screen.
User Manual MK/YF38-07 – V2.01CS 4.5 Patient and clinician modes The equipment can be adjusted in two modes: namely Patient and Clinician. Patient Mode: in this mode, users can adjust a limited number of parameters which relate to comfort, convenience and day to day device usage. Clinicians Mode: in this mode, professional technicians and medical staff can adjust all parameters, including treatment pressure and CPAP/Auto mode selection (for C5 Auto Machine only).
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User Manual MK/YF38-07 – V2.01CS (2) Status Bar The grey status bar in the upper part of the display is used to show symbols of features that have been enabled and any alert messages. The symbols in status bar have following meanings: Comfort.
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User Manual MK/YF38-07 – V2.01CS (3) Operation menu [Treat]: used to start and stop the therapy (airflow) treatment. [Preheat]: the humidifier can be turned on in advance of treatment to pre-heat the distilled water, ready to provide the soonest humidification. [Set]: used to set the device; Param: Parameters such as Comfort, Humidifier, Auto ON, Auto OFF and;...
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User Manual MK/YF38-07 – V2.01CS (4) Treatment Screen During treatment, the screen will display information similar to the one shown below. Auto CPAP or CPAP: Depending on the model (C2 = CPAP, C5 = Auto-CPAP) Time: Time in use since treatment therapy last started. Pressure: The real-time therapy pressure the device is delivering.
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User Manual MK/YF38-07 – V2.01CS (5) Info Menu After [Info] has been selected on the menu, a treatment summary can be displayed on the screen for the last 1 day, 7 days or 30 days. “1-day”, “7-day” and “30-day” displays a basic treatment summary report for the period selected. Tip: At 9am each morning, this information updates.
User Manual MK/YF38-07 – V2.01CS 4.7 Clinician mode Warning: non-professional staff are forbidden to access the Clinicians Mode. 4.7.1 Enter clinician mode (1) Power up the equipment, then move the cursor to display [Set] on the screen (2) Press and hold the control dial for 5 seconds until [Mode] is displayed (3) The clinician can now make setting adjustments 4.7.2 Return to patient mode (1) Rotate the control dial until [Exit] shows on the screen, then press the control dial.
User Manual MK/YF38-07 – V2.01CS 4.8 Treatment setting parameters Parameter Setting range Description Mode Patient Mode Exit Return to the previous menu Clinician Mode CPAP Mode: provides continuous positive airway CPAP pressure ventilation. Auto-CPAP Mode (C5 only): Clinician Mode Treatment provides automatic adjustment Mode varying the positive airway Auto CPAP...
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User Manual MK/YF38-07 – V2.01CS easier it will be to breathe out against the airflow. Typically used in CPAP Mode, the Ramp feature allows the Patient Mode OFF or 5~45 Machine to start at a lower Ramp time minutes pressure and slowly ramp up to Clinician Mode the treatment pressure over the Ramp time selected.
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User Manual MK/YF38-07 – V2.01CS moisture is added to the airflow treatment. Too much moisture will cause water droplets in the hose or mask. If the Machine is to be used without the humidifier, the humidifier setting must be set to OFF. Select preheat Patient Mode...
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User Manual MK/YF38-07 – V2.01CS around 10 seconds. Depending on the type of mask, accurate detection of the mask being removed may not always be possible. If “Auto off” function is turned off: During use, the Machine will not automatically stop the airflow when the mask has been removed.
User Manual MK/YF38-07 – V2.01CS Patient Mode Language Chinese/English Choose the language you prefer. Clinician Mode To reset the Machine back to the factory default settings, select Patient Mode Reset Clinician Mode Compliance Use is not reset. Patient Mode Display the software version of Version the equipment.
User Manual MK/YF38-07 – V2.01CS Chapter 5 Heating humidifier 5.1 Intended use The heated humidifier uses a sprung metal plate to transfer heat to distilled water in the water tank. This provides heated and humidified air to ensure a more comfortable therapy experience for the user.
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User Manual MK/YF38-07 – V2.01CS 5.3 Cautions It is advised to only use distilled water to prevent scale and calcification occurring which can result in corrosive holes. It is necessary to clean the heating humidifier and change the water in it every day so ...
User Manual MK/YF38-07 – V2.01CS Chapter 6 WIFI 6.1 Expected usage This equipment is provided with an in-built 2.4GHz WIFI module that can connect with the M+ cloud service platform provided by the manufacturer. This platform can collect data including but not limited to the setup parameters, treatment information, and treatment report generated during the user treatment process for analysis of user treatment effect and supply of better subsequent service.
User Manual MK/YF38-07 – V2.01CS Chapter 7 Alerts 7.1 Visual and Audible Alerts If an unexpected fault event occurs with the Machine during use, an alert message in red text will be displayed in the upper left corner of the screen, accompanied by an audible beeping sound.
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User Manual MK/YF38-07 – V2.01CS must be switched off humidifier off in the [Set] > electronically first, [Param] menu. otherwise an alert will be If the problem persists, given after 40 seconds. contact your service provider. Disconnect the power supply, wait for 1 minute, If the pressure sensor then re-apply the power and Pressure...
User Manual MK/YF38-07 – V2.01CS Check if there is any damage to the hose or face mask; ensure the The mask or tubing The pressure sensor connection between the air hose is detects a problem for over outlet and hose is normal Disconnecti disconnected from 30 seconds, an alert will...
User Manual MK/YF38-07 – V2.01CS Chapter 8 Equipment cleaning and maintenance 8.1 Repair and maintenance If the equipment or accessories are damaged, or their original functions can’t be guaranteed, discontinue use of the equipment. If you need to have the equipment repaired, cleaned, preventively checked or maintained, please contact your equipment provider or manufacturer (Micomme Medical) 8.2 Frequency Based on standard hygiene considerations, the manufacturer recommends the following...
User Manual MK/YF38-07 – V2.01CS Warnings: 1.When the equipment is used by more than one user, the filter should be replaced for each user. 2. Clean the respiration hose and face mask by referring to the individual cleaning instructions included with these accessories. 8.3.2 Water tank cleaning Remove the water tank from the humidifier and wash in warm soapy water with a mild liquid disinfectant.
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User Manual MK/YF38-07 – V2.01CS 8.3.4 Machine cleaning This CPAP Machine has a built-in ozone cleaning function. The cleaning cycle takes approximately 30 minutes to complete and will clean the CPAP Machine including motor, humidifier, hose and water tank. Make sure that there is no water in the water chamber before cleaning. ...
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User Manual MK/YF38-07 – V2.01CS 4. Remove the mask from the hose and connect the hose to the ozone circulation joint forming a loop connection as shown below; 5. Move the cursor on to [System] > [Clean] then press the control dial button. Follow the on- screen instructions, then select (Yes) to start the cleaning process.
User Manual MK/YF38-07 – V2.01CS Chapter 9 Storage and transportation 9.1 Storage The packed CPAP Machine can be stored in a clean and well ventilated room that has an ambient temperature of -10-55℃ and relative humidity of 15-95%, and is free from any corrosive gas.
User Manual MK/YF38-07 – V2.01CS Chapter 10 Troubleshooting In the unlikely event of a fault occurring, the please refer to the possible causes and solutions in the following table; Fault/error message Cause Solution Check wall socket is switched on and the AC No AC Power.
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User Manual MK/YF38-07 – V2.01CS Regulate the room temperature and keep The equipment is the equipment away from direct sunlight and The equipment close to heater or in heating devices. temperature is bright sunshine or it is excessively high If the error persists, contact your equipment a hot day.
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User Manual MK/YF38-07 – V2.01CS Adjust the headgear to properly wear the Air leak with the face face mask and prevent air leaks. When mask. necessary, change the face mask. Damaged face mask. Replace the damaged face mask. Machine settings need Contact your equipment provider. adjusting.
User Manual MK/YF38-07 – V2.01CS Language: English Time and Date: Australian Eastern Standard Time (AEST = UTC+10h) 11.1.3 AC Adapter parameters Specified Adapter Model: HY72-024 Specified Adapter Manufacture: ShenZhen Hongyi Electronic Technology CO. Ltd. 11.1.4 Machine ambient parameters Parameter Working conditions Storage conditions Temperature 5ºC ~...
User Manual MK/YF38-07 – V2.01CS 11.1.6 Electric safety class Parameter Value Safety class against electric shock Class II Electric shock protection degree BF application component Waterproof level IP21 Mode of operation Continuous operation Safety class when used in combustible It can’t be used in combustible anesthetics mixed with air or oxygen or helium anesthetics mixed with air or oxygen or oxide...
User Manual MK/YF38-07 – V2.01CS 11.2 Pneumatic schematic diagram The pneumatic schematic diagram of the equipment is as follows: 11.3 EMC information 11.3.1 Instructions for use The Sleep Apnea Therapy Devices referred to in this User Manual are are suitable for home healthcare environments.
User Manual MK/YF38-07 – V2.01CS degraded due to EM DISTURBANCES.(For details, see Chapter 9 Fault Analysis and Troubleshooting) 11.3.2 Technical description Table 1 Guidance and manufacturer’s declaration - electromagnetic emissions Emissions test Compliance RF emissions Group 1 CISPR 11 RF emissions Class [B] CISPR 11 Harmonic emissions...
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User Manual MK/YF38-07 – V2.01CS Table 2 Guidance and manufacturer’s declaration - electromagnetic Immunity Immunity Test IEC 60601-1-2 Compliance level Test level Electrostatic discharge ±8 kV contact ±8 kV contact (ESD) ±2 kV, ±4 kV, ±8 kV, ±15 kV air ±2 kV, ±4 kV, ±8 kV, ±15 kV air IEC 61000-4-2 Electrical fast ±2 kV for power supply lines...
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User Manual MK/YF38-07 – V2.01CS Conduced RF IEC61000-4-6 0,15 MHz – 80 MHz 0,15 MHz – 80 MHz 6 V in ISM and amateur radio 6 V in ISM and amateur radio bands bands between 0,15 MHz and between 0,15 MHz and 80 MHz 80 MHz 80 % AM at 1 kHz 80 % AM at 1 kHz...
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