Health GEAR SleepZone C2 User Manual

Health GEAR SleepZone C2 User Manual

Sleep apnea therapy devices
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User Manual 
MK/YF38-07 – V2.01CS 
User Manual
Sleep Apnea Therapy Devices
Models: C2 (CPAP) & C5 (AUTO CPAP)
 
 
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© 2019 All Rights Reserved 

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Summary of Contents for Health GEAR SleepZone C2

  • Page 1   User Manual  MK/YF38-07 – V2.01CS  User Manual Sleep Apnea Therapy Devices Models: C2 (CPAP) & C5 (AUTO CPAP)     Page 1 of 60 © 2019 All Rights Reserved ...
  • Page 2   User Manual  MK/YF38-07 – V2.01CS  (This page intentionally left blank)     Page 2 of 60 © 2019 All Rights Reserved ...
  • Page 3: Table Of Contents

      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  ...
  • Page 4   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  ...
  • Page 5   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  ...
  • Page 6: Preface

      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.
  • Page 7: Chapter 1 Product Overview

      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);...
  • Page 8: Working Principle

      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.
  • Page 9   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.
  • Page 10: Cautions

      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).
  • Page 11: Contraindications

      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 ...
  • Page 12: Potential Side Effects And Solutions

      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; ...
  • Page 13: Chapter 2 Appearance And Accessories

      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.
  • Page 14: Components And Parts

      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;...
  • Page 15   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...
  • Page 16: Notes About Terminologies And Acronyms

      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.
  • Page 17   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.
  • Page 18: Chapter 3 Installation And Operation

      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.
  • Page 19: Connect The Hose To The Mask

      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.
  • Page 20   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.
  • Page 21: Connect The Hose To The Machine

      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] >...
  • Page 22: Chapter 4 Equipment Use

      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.
  • Page 23: Starting Treatment

      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.
  • Page 24: Patient And Clinician Modes

      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).
  • Page 25   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.
  • Page 26   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;...
  • Page 27   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.
  • Page 28   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.
  • Page 29: Clinician Mode

      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.
  • Page 30: Treatment Setting Parameters

      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...
  • Page 31   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.
  • Page 32   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...
  • Page 33   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.
  • Page 34: Data Output

      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.
  • Page 35: Chapter 5 Heating Humidifier

      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.
  • Page 36   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 ...
  • Page 37: Chapter 6 Wifi

      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.
  • Page 38: Chapter 7 Alerts

      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.
  • Page 39   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...
  • Page 40: Alert Suspension

      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...
  • Page 41: Chapter 8 Equipment Cleaning And Maintenance

      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...
  • Page 42: Water Tank Cleaning

      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.
  • Page 43   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. ...
  • Page 44   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.
  • Page 45: Chapter 9 Storage And Transportation

      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.
  • Page 46: Chapter 10 Troubleshooting

      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.
  • Page 47   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.
  • Page 48   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.
  • Page 49: Chapter 11 Technical Information

      User Manual  MK/YF38-07 – V2.01CS  Chapter 11 Technical information 11.1 Parameters 11.1.1 Default C2 CPAP Machine Settings  CPAP Mode  CPAP: 10cmH20  Humidifier: 2  Pre-Heat: Off  Comf: Off  Auto on: On  Auto off: On  Ramp time: 10 minutes ...
  • Page 50: Ac Adapter Parameters

      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 ~...
  • Page 51: Electric Safety Class

      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...
  • Page 52: Pneumatic Schematic Diagram

      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.
  • Page 53: Technical Description

      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...
  • Page 54   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...
  • Page 55   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...
  • Page 56   User Manual  MK/YF38-07 – V2.01CS  704 – Pulse   Band 13, modulation 217 Hz 800 – Pulse   800/900, modulation TETRA 18 Hz 800, iDEN 820, CDMA 850, Band 5 1720 1 700 Pulse   – 1800; modulation 1845 1 990 CDMA 217 Hz 1970 1900;...
  • Page 57: Rf Information

      User Manual  MK/YF38-07 – V2.01CS  2450 2 400 Bluetooth Pulse   – modulation 2 570 WLAN, 217 Hz 802.11 b/g/n, RFID 2450, Band 7 5240 5 100 WLAN Pulse   – 802.11 modulation 5240 5 800 217 Hz 5785 11.3.3 RF information For WIFI For BLE Operating Frequency: 2400~2483.5MHz...
  • Page 58: Appendix 1: Model Comparison Table

      User Manual  MK/YF38-07 – V2.01CS  Appendix 1: Model comparison table Note:●Standard ○ Optional - Not Available CPAP ● ● Mode AUTOCPAP ● BPAP Minimum Pressure 4cmH 4cmH Maximum Pressure 20cmH 20cmH Comfort Level ● ● Therapeutic Effects 45 Minute Ramp ● ● Heated Humidifier ●...
  • Page 59: Appendix 2: Warranty And Downloads

      User Manual  MK/YF38-07 – V2.01CS  Appendix 2: Warranty and Downloads Review and download latest content as shown below;  Warranty Policy www.cpapsales.com.au/refunds-warranty-and-returns  Quick Start Guide www.cpapsales.com.au/manuals  User Manual www.cpapsales.com.au/manuals  WiFi Setup www.cpapsales.com.au/wifi-setup  FAQ (Frequently Asked Questions) https://cpapsales.freshdesk.com/support/home    ...
  • Page 60   User Manual  MK/YF38-07 – V2.01CS  ARTG Number: 319236 Distributed by: CPAP Sales Pty Ltd ABN: 81 164 927 539 PO Box 118, Riverstone, NSW 2765, Australia Phone: 1300 04 2727 Email: support@cpapsales.com.au Website: www.cpapsales.com.au Manufactured by: Micomme Medical Technology Development Co. Ltd Room 101-102, North 1st Floor, Superstar Enterprise Center, No 8, Lujing Road, High-Tech Zone, Changsha, Hunan, P.R.China  ...

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Sleepzone c5

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