HealthGear CPAP and Auto User Manual v2.02CS

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User Manual MK/YF38-07 – V2.

02CS

User Manual
Sleep Apnea Therapy Devices

Models: C2 & C5

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© 2020 All Rights Reserved
User Manual MK/YF38-07 – V2.02CS

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User Manual MK/YF38-07 – V2.02CS

Contents

PREFACE ...............................................................................................................................6

CHAPTER 1 PRODUCT OVERVIEW .................................................................................... 7

1.1 INTENDED PURPOSE, PRODUCT USAGE AND APPLICATION ................................................... 7

1.2 WORKING PRINCIPLE .......................................................................................................... 8

1.3 SAFETY TIPS .......................................................................................................................8

1.3.1 WARNING ................................................................................................................................... 8

1.3.2 CAUTIONS ................................................................................................................................ 10

1.3.3 CONTRAINDICATIONS .............................................................................................................. 11

1.3.4 POTENTIAL SIDE EFFECTS AND SOLUTIONS ........................................................................... 12

CHAPTER 2 APPEARANCE AND ACCESSORIES ........................................................... 13

2.1 ABOUT THE MODEL ........................................................................................................... 13

2.2 COMPONENT SUMMARY .................................................................................................... 13

2.3 COMPONENTS AND PARTS................................................................................................. 14

2.4 NOTES ABOUT TERMINOLOGIES AND ACRONYMS ............................................................... 16

2.5 ABOUT THE SIGNS ............................................................................................................ 16

CHAPTER 3 INSTALLATION AND OPERATION ............................................................... 18

3.1 PLACEMENT LOCATION ..................................................................................................... 18

3.2 SET UP ............................................................................................................................. 18

3.2.1 PRE-ASSEMBLY PREPARATION................................................................................................ 18

3.2.2 CONNECT POWER TO THE MACHINE ...................................................................................... 18

3.2.3 CONNECT THE HOSE TO THE MASK ........................................................................................ 19

3.2.4 FILL THE WATER TANK ............................................................................................................. 19

3.2.5 CONNECT THE HOSE TO THE MACHINE .................................................................................. 21

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CHAPTER 4 EQUIPMENT USE .......................................................................................... 22

4.1 PRE-START INSPECTION - MACHINE .................................................................................. 22

4.2 PRE-START INSPECTION - MASK........................................................................................ 22

4.3 STARTING TREATMENT ...................................................................................................... 23

4.4 STOPPING TREATMENT...................................................................................................... 23

4.5 PATIENT AND CLINICIAN MODES ........................................................................................ 24

4.6 PATIENT MODE .................................................................................................................. 24

4.6.1 ENTER PATIENT MODE ............................................................................................................. 24

4.6.2 PATIENT MENU ......................................................................................................................... 24

4.7 CLINICIAN MODE ............................................................................................................... 29

4.7.1 ENTER CLINICIAN MODE .......................................................................................................... 29

4.7.2 RETURN TO PATIENT MODE ..................................................................................................... 29

4.7.3 CLINICIAN MENU ...................................................................................................................... 29

4.8 TREATMENT SETTING PARAMETERS .................................................................................. 30

4.9 DATA OUTPUT ................................................................................................................... 34

CHAPTER 5 HEATING HUMIDIFIER .................................................................................. 35

5.1 INTENDED USE .................................................................................................................. 35

5.2 SPECIFICATIONS ............................................................................................................... 35

CHAPTER 6 WIFI ................................................................................................................. 37

6.1 EXPECTED USAGE ............................................................................................................ 37

CHAPTER 7 ALERTS .......................................................................................................... 38

7.1 VISUAL AND AUDIBLE ALERTS .......................................................................................... 38

7.2 ALERT MESSAGES ............................................................................................................ 38

7.3 ALERT SUSPENSION ......................................................................................................... 40

CHAPTER 8 EQUIPMENT CLEANING AND MAINTENANCE .......................................... 41


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8.1 REPAIR AND MAINTENANCE ............................................................................................... 41

8.2 FREQUENCY ..................................................................................................................... 41

8.3 CLEANING METHOD ........................................................................................................... 41

8.3.1 CLEANING OF CPAP MACHINE AND HOSE ............................................................................. 41

8.3.2 WATER TANK CLEANING .......................................................................................................... 42

8.3.3 AIR FILTER CLEANING AND REPLACEMENT ............................................................................. 42

CHAPTER 9 STORAGE AND TRANSPORTATION ........................................................... 45

CHAPTER 10 TROUBLESHOOTING ................................................................................. 46

CHAPTER 11 TECHNICAL INFORMATION ....................................................................... 49

11.1 PARAMETERS ................................................................................................................. 49

11.1.1 DEFAULT C2 MACHINE SETTINGS ............................................................................. 49

11.1.2 DEFAULT C5 MACHINE SETTINGS ................................................................................ 49

11.1.3 AC ADAPTER PARAMETERS .................................................................................................. 50

11.1.4 MACHINE AMBIENT PARAMETERS ......................................................................................... 50

11.1.5 PHYSICAL AND ELECTRICAL PARAMETERS ........................................................................... 50

11.1.6 ELECTRIC SAFETY CLASS ..................................................................................................... 51

11.2 PNEUMATIC SCHEMATIC DIAGRAM ................................................................................... 52

11.3 EMC INFORMATION ......................................................................................................... 52

11.3.1 INSTRUCTIONS FOR USE ....................................................................................................... 52

11.3.2 TECHNICAL DESCRIPTION ..................................................................................................... 53

11.3.3 RF INFORMATION .................................................................................................................. 57

APPENDIX 1: MODEL COMPARISON TABLE .................................................................. 58

APPENDIX 2: WARRANTY AND DOWNLOADS ............................................................... 59

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Preface

is a registered trademark of CPAP Sales Pty Ltd (hereinafter CPAP


Sales)

Models C2 and C5 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.

Micomme Medical reserves all the rights to information contained in the document. Unless
specially authorized by Micomme Medical in written form, nobody can copy any part of the
document in any way or save it into any electronic information retrieval system. No unit,
corporation or individual shall produce, sell or copy our products without being authorized by
our company; or it shall be deemed as an infringement of our protected patents, and our
company reserves the right to take any legal action against such infringement.

No additional notice shall be provided in case of any change in the information contained in
this document. Micomme Medical reserves the right to change equipment design,
performance, components and processes including any other circumstances to continually
improve product and quality assurance.

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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); it may also be intended to treat

snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway

pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor

(auto CPAP). The device is intended for use in the home but may also be used in healthcare

facilities.

Models C2 and C5 are Obstructive Sleep Apnea Therapy Devices (hereinafter referred to as a

“CPAP Machine”) providing non-invasive ventilation treatment for patients with obstructive

sleep apnea syndrome (OSAS). These CPAP Machines are for use by pediatric

patients aged over 7 (with a weight being over 18.1kg or 40lbs) and adult patients (with a

weight being over 30kg and 66lbs) only.

This CPAP Machine should be used by patients under the guidance of professionally trained

medical staff, with patient as the intended end user/operator. Patients with severe respiratory

failure but spontaneous breath should not use a CPAP Machine unless instructed to do so by a

medically trained professional.

CPAP Machines need to be used together with a breathing hose and a nasal/face mask

suitable to the patient.

To download this User Manual, please visit: cpapsales.com.au/manuals

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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. The CPAP Machine’s system can collect information about the

patient’s compliance use and Machine operating performance.

1.3 Safety tips

Warnings, cautions and notes apply to the whole User Manual.

1.3.1 Warning

 The User Manual is for reference only. The description in it can’t substitute the
guidance of professional medical staff.

 Before using the equipment, please read through and understand the User Manual.

 The equipment is not designed to meet your complete ventilation demand or to be


used as life support system.

 Since there is no circuit of expiration in the Ventilator, the user should be provided with
a face mask with at least 30LPM air-leaking holes to avoid repeated inhalation of the
carbon dioxide resulting from the breath.

 The treatment parameters must be adjusted by trained professional medical staff.

 In case of any discomfort in the equipment use, please immediately contact your
professional medical staff.

 Use only the expiration circuit provided by your professional medical staff instead of
any anti-static or conductive hose or conduit.

 Winding due to cables and breathing hoses, particularly due to excessive length.

 Do not bend or wrap the breathing line during use.

 When using the breath circuit integrated with expiration holes mask or circuit with
independent outlet device, do not bind or seal the air leaking holes, or block the fresh
air inlet with adhesive tape, seal or other substances, for it may stop the inspiration of
fresh air and even lead to suffocation.

 When the equipment is working, do not cover it with any article, or else the fresh air
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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.

 In order to ensure normal use, the power supply must be inserted into the socket in a
vertical way.

 Do not use this equipment alone for pediatric patients over 7 years old.

 Please keep the equipment away from children and pets.

 Against servicing and maintenance while the equipment is in use.

 Regularly check if there is any damage or wearing sign in the electric wire, cable or
power supply device; if there is any, please stop using the device and arrange a
replacement.

 The plug is used as disconnect device to the mains supply, do not to position the ME
EQUIPMENT so that it is difficult to operate the disconnection device.

 To avoid electric shock, please disconnect the plug before cleaning the equipment.

 The equipment maintenance and repair can only be done by the professional
repairman authorized by Micomme Medical.

 No modification of this equipment is allowed.

 Do not use the equipment when the room temperature is above 35℃, for the
temperature of the air flow in such case may exceed 43℃, and stimulus or damage
may be caused to your air passage.

 Keep the equipment from sunshine or heating device when using it, for the air
discharged from the equipment in such case may have an elevated temperature.

 Before using the equipment, please check if the present warning SET is suitable for
the patient. Improper warning preset in different areas may bring damage to the
patient.

 When using the equipment, please prepare simple respirator or other Machine that
can substitute the equipment for the time being so that the normal treatment of patient
will not be interrupted and no damage is caused to the patient in case of sudden
failure with the equipment.

 When noticing an unexplainable change or abnormal or annoying noise with the


working equipment,

 If necessary, our company (Micomme Medical) may provide the technical files (e.g.
circuit diagram, list of elements, legends, and detailed rules and regulations about
calibration) required for the purpose of repair for the qualified technical maintenance
and repair staff either designed by us or of other types.

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 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). Furthermore all configurations shall comply
with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16
of the 3Ed. of IEC 60601-1, respectively).

 Anybody connecting additional equipment to medical electrical equipment


configurations a medical system and is therefore responsible that the system complies
with the requirements for medical electrical systems. Attention is drawn to the fact that
local laws take priority over the above mentioned requirements. If in doubt, consult
your local representative or the technical service department.

 Sources of oxygen must be located more than 1 m from the equipment to avoid the
risk of fire and burns.

1.3.2 Cautions

 The equipment can only be operated in the ambient environment of 5℃-35℃.

 To assure normal working, an undamaged reusable sponge filter should be properly


fixed at the air inlet.

 The equipment should not be immersed in any liquid, and no liquid is allowed to enter
into its enclosure or inlet filter.

 Condensation may damage the equipment. Please raise the equipment temperature to
the room temperature before using it.

 Do not cover the equipment with such objects as blanket; or the fresh air intake may
be blocked so that the Machine become overheated to affect the treatment or damage
the equipment.

 The equipment isn’t provided with power-off alert or power-off-resistant design. Within
it, there is no battery supply. Therefore, during the use, please ensure the adapter
power plug and equipment are properly connected, the power line is reasonably
placed in order to prevent the power plug from falling off from the equipment under
external force and consequent patient suffocation with harder respiration.

 In case of recovery of power supply after an interruption, the equipment should be


restarted in treatment in order to assure normal working.

 The waste and residue generated by the equipment as well as the expiry equipment
and its accessories should be classified before treatment so as to prevent
environmental pollution or other hazards.

 The pressure sensor of the equipment remains as a key pressure test device, so it

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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
of equipment with mains will not affect the SET of all such parameters.

 Replacement of parts shall be made by the parts specified by the manufacturer of the
equipment and by the maintenance personnel designated by the manufacturer.

1.3.3 Contraindications
When having severe respiratory failure and no spontaneous breath, please do not use the
equipment.

When any of following situations applies to you, please consult professional medical staff
before using the equipment;

 Insufficient respiratory drive to tolerate the intermittence of non-invasive ventilation


treatment;

 Acute sinusitis and otitis media;

 Some diseases that may cause intake of stomach contents;

 Inability to clear the secretion;

 Hypotension or apparent hypovolemia within blood vessel;

 Pneumothorax or mediastinal emphysema;

 Craniocerebral trauma or surgery;

 receiving airway neostomy in the past;

 Pulmonary bulla.

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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;

 Chest discomfort.

When having any discomfort during the use, please immediately seek medical advice from

professional medical staff or consult with the supplier.

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Chapter 2 Appearance and accessories

2.1 About the model

The CPAP Machine product is coded as follows:

B/C 5/3/2/1

Version
版本代号
双水平压力/单水平压力
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. It is recommended to use matching parts and materials

recommended by the equipment manufacturer. Please consult your equipment supplier or

manufacturer when planning to use other alternative products; or the safety performance of the

equipment may be affected.

1. Machine with Humidifier 2. Power adapter with Australian Power Cord

3. Hose 4. Ozone circulation joint connector

5. Accompanying documents: Quick Start Guide and Packing List.

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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; increase the value of selected parameter by rotating


Control Dial
the dial clockwise and decrease it by rotating the dial

counterclockwise.

Displays settings, and real-time data including working pressure


Colour Display
and air leakage.

Green light indicates the Machine is powered. When not lit, it


Power LED
indicated the Machine is disconnected from the power supply.

Humidifier Lid Open Press the humidifier lid open button to lift up the humidifier lid and

Button pull out the water tank.

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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

blocked at any time.

Humidifier Lid Press the button to allow the humidifier lid to be opened upwards

Release button and allow the removal of the water tank.

The water tank can be removed and filled with distilled water for
Water tank (Inside
later use. The amount of water should be less than the max
Humidifier)
indicator line.

Heating plate (Inside There is a heater plate within the base of the humidifier for heating

Humidifier) the water tank.

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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

cmH2O Pressure unit, cmH2O.

AHI Apnea and hypopnea index: the frequency of apnea and

hypopnea incidence in each hour.

95% pressure This is a value of pressure. In a period of treatment the

treatment pressure of the Machine is lower than this value for

95% of the treatment time.

LEAK Air leakage: the air flow leaking from the hose or face mask

during the treatment.

2.5 About the signs

You may find following signs on the equipment or when using the device.

Please read carefully before use.

Sign Definition

Attention

BF application component

Category II (double insulation)

IP21 Dustproof waterproof level

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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.

Comfort level function.

Icon indicating startup of heating and humidifying Machine.

WIFI on (Feature not currently available in Australia)

Hot surface

Direct current

Refer to instruction manual/booklet

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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. A distance of at least 5cm should be kept between the

equipment and wall to ensure the equipment’s air inlet is not covered by curtains, quilts or

other objects. The air around the equipment should keep moving smoothly and away from any

heating or cooling device (such as forced vent, radiator, and air conditioning) to ensure the

system can work normally.

3.2 Set up

Your Machine will already have been pre-set by your equipment provider and should be ready

to use without any adjustments. A Quick Start Guide was supplied with this Machine to help you

get started.

3.2.1 Pre-assembly preparation

The Machine with humidifier are already assembled. No pre-assembly is required.

3.2.2 Connect power to the Machine

Fit the power cord and power supply together. Connect the mains plug to the AC wall socket and
the 24VDC plug into the back of the Machine.

Caution: please ensure the power line is inserted firmly to prevent the power supply becoming

loose in case of equipment movement.

Attention! Do not connect the device to any unauthorised devices unless recommended by

the manufacturer or your health care provider.

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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.

3.2.4 Fill the water tank

Before use, please ensure the water within the tank is below the max indicator line.

Warning: Do not activate the humidification function when there is no water tank or no

water within the water tank.

Remove the water tank by pressing the lid release button on the upper cover of the humidifier

and gently lift the cover upwards.

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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.

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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] > [Param] menu.

In this case, select the desired setting between 1 and 5 based on personal comfort and

environmental conditions. The higher the number, the more moisture is added to the airflow

treatment. Too much moisture will cause water droplets in the hose or mask.

The humidifier can also be turned off in the [Set] > [Param] menu.

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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. In the event that the

CPAP Machine fails to display this menu after 2 seconds, please check all power connections

points. After the main menu appears, the [Treat] option should be highlighted, indicating the

CPAP Machine is ready for use.

4.2 Pre-start inspection - Mask

The CPAP Machine is designed to be used together with a CPAP mask. For further information

regarding the mask, please use the manual provided with the mask.

Please wear the face mask by following the steps below:

1. Connect the headband with the face mask (ensuring the headgear is correctly orientated);

2. Position the mask on the face;

3. Adjust the tightness of the headgear so that face mask is slightly pressing on the face

without causing any indentations;

4. The mask should be worn firmly but not uncomfortably to avoid leaks.

Attention! If the Machine is not in proper working condition, sufficient fresh air cannot be

provided. In this case carbon dioxide can build within the mask and cause discomfort. When

applying the mask prior to sleep, please ensure the air flow starts correctly on the Machine.

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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.

When the equipment is connected correctly, the screen display will light up and then

automatically turn off after 15 seconds. The backlight timing can be changed in the [System] >

[Backlight] menu. Options are 15, 30, 45, 60 seconds, and ON full time. You can illuminate the

screen back at any time by pressing or turning the control dial.

If “Auto On” has been enabled, airflow will start automatically once breathing has been

detected through the face mask.

Tip: Leave the Machine with [Treat] showing on the screen so that the device is ready to begin

the next therapy session.

The Machine contains an internal memory. This ensures that all settings applied to the

Machine, including treatment mode, treatment pressure, humidifier level, ramp time, and

COMF remain the same as before the last shutdown or power disconnection. On the initial

startup, the settings applied will be those set by your service provider, or the default settings.

4.4 Stopping treatment

To cease the airflow, press the control dial once to wake up the screen, then press and hold

the control dial for 3 seconds until the airflow stops.

If “Auto OFF” has been enabled, airflow should stop 10 seconds after mask removal.

Depending on the brand and type of mask, accurate detection may not always be possible.

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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 Machine

only).

Warning: non-professional staff are forbidden to access the Clinicians Mode.

4.6 Patient mode

4.6.1 Enter patient mode

Power on the equipment and wait for 2s or so, the equipment will automatically enter the

Patient Mode and display the idle menu.

4.6.2 Patient menu

(1) Main menu

After the equipment is connected correctly, the following idle menu will appear.

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(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. This icon will appear when exhalation pressure relief comfort setting
between 1 and 3 has been enabled and set. With this setting enabled, it will be easier to breath

out against the airflow coming in. This can be helpful for some patients, especially those using

nasal pillow masks.

Heated Humidifier: This icon will appear when the heated humidifier has been

enabled. The number relates to the level of humidification that has been set, from 1 (minimum

moisture) to 5 (maximum moisture). The factory default setting is 2. Select the desired setting

based on personal comfort and environmental conditions.

The higher the number, the more moisture is added to the airflow treatment. Too much

moisture will cause water droplets in the hose or mask.

Tip: If the Machine is to be used without the humidifier, the humidifier setting must be set to

OFF in the [Set] > [Param] menu.

WIFI: This icon will be displayed when the Machine has been successfully connected

to a home WiFi network (2.4GHz only) in the [System] > [Network] menu.

When this function is set up and activated, the equipment will be automatically connected with

WIFI to upload the treatment data to a remote server so that the medical staff can learn about

the Machine use state.

Tip: This feature is not currently available in Australia.

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(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;

Time: Date settings including Year, Month, Date, Hour and Minutes.

[System]: used to;

Output: Save historical therapy data to the USB stick;

Network: Set up and check device connection to a 2.4GHz home WiFi

Update: only use if instructed by your service provider to download new

operating software;

Diagnose: used to display simple percentage feedback of therapy use;

Clean: used to start ozone cleaning cycle;

Backlight: used to set time for display to stay lit;

Language: English or Chinese options;

Reset: used to reset Machine settings back to factory default settings. Usage

and compliance data cannot be reset.

Version: used to display current software version of the device;

[Info]: used to show key information relating to the CPAP therapy treatment including AHI,

P95, Leakage, Treatment Time and Treatment Days over the following time periods; 1

Day: 7 Days: 30 Days. Total Work Time (Run Time) can also be viewed here. At 9am each

morning, this information updates. Eg. The 1 day info resets to zero.

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(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. Typically, a number

between 4 and 20cmH20. The IPAP/EPAP state is also displayed. I = Inspiration

(breathing in), and E = Expiration (breathing out)

Leak: The leak value (typically hose, mask or mouth leak) will vary during use and is

displayed in the bottom left corner of the display. This value will turn red if the leak is

excessive, exceeding 60litres/minute.

All masks have an intentional leak to prevent inhalation of your own breath which contains

carbon dioxide. The intentional leak value varies depending on the type and brand of

mask, but is typically around 20~30l/m.

AHI; Apnea Hypopnea Index. Shows the number of events per hour, where no breathing

or shallow breathing has occurred for 10 seconds or more. The target AHI is under 5/hour,

and the lower the number the better.

P95: The pressure or less at which the Machine has been running at for 95% of the time.

The AHI and P95 displayed during therapy are the results of the last treatment session.

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(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. Eg. The 1 day info resets to zero.

(6) Menu Navigation:

Step 1: Rotate the control dial left or right to wake up the screen.

Step 2: Rotate the control dial to move the cursor to the setting requiring adjustment.

Step 3: Press the control dial and move the cursor to adjust the setting.

Step 4: Rotate the control dial left or right to choose the parameter to be set.

Step 5: Repeat step 2-4 to continue with the setting of other parameters.

Step 6: Rotate the control dial to show [Exit], and press to return to the home screen.

Tip: Leave the Machine with [Treat] showing on the screen so that the device is ready to begin

the next therapy session.

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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. Repeat

this process until “Exit” can no longer be seen when rotating the control dial.

4.7.3 Clinician menu

Select ”Mode” to adjust treatment mode and treatment pressure.

Select ”Param” to adjust additional including Ramp time and Ramp starting pressure.

The range of available setting options will depend on the device model. C2 is for CPAP

Machines, C5 is for Auto-CPAP Machines.

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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
selection Auto CPAP
pressure as per the airway

obstruction state.

Select the Treatment Pressure

based on the patient’s

prescription. This will be one


CPAP 4~20cmH20 Clinician Mode
value between 4cmH20 and

20cmH20 in 0.5cmH20

increments.

Set the upper pressure limit for


Max CPAP 4~20cmH20 Clinician Mode
automatic CPAP ventilation

Set the lower pressure limit for


Min CPAP 4~20cmH20 Clinician Mode
automatic CPAP ventilation.

Switch exhalation pressure relief

comfort technology OFF, or Patient Mode


COMF OFF, 1, 2, 3
choose a setting of 1, 2 and 3. Clinician Mode

The higher the number, the

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easier it will be to breathe out

against the airflow.

Typically used in CPAP Mode,

the Ramp feature allows the

OFF or 5~45 Machine to start at a lower Patient Mode


Ramp time
minutes pressure and slowly ramp up to Clinician Mode
the treatment pressure over the

Ramp time selected.

When a Ramp time has been

selected, choose the starting

pressure. Over the Ramp time

selected, the Machine pressure

will slowly rise until;

a) The CPAP Treatment


4cmH2O ~ CPAP Pressure has been reached Patient Mode
Ramp start Pressure (CPAP Mode only)
Clinician Mode
or

4cmH20 ~ min b) The min CPAP pressure has


CPAP pressure been reached (Auto CPAP Mode

only)

Stop and restart the Machine to

begin the Ramp time again.

Select the desired setting based

on personal comfort and Patient Mode


Humidifier OFF. 1,2,3,4,5
environmental conditions. Clinician Mode

The higher the number, the more

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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 ON to preheat the


Patient Mode
Preheat ON or OFF humidifier to level 1 in advance of
Clinician Mode
starting the treatment.

If “Auto on” function is turned on:

In idle state with [Treat] showing

on the display, the Machine will

detect and automatically start

the airflow when breathing Patient Mode


Auto on ON or OFF
through the connected mask is
Clinician Mode
detected.

If “Auto on” function is turned off:

The Machine will not

automatically start.

If “Auto off” function is turned on:

During use, the Machine will


Patient Mode
detect if the mask has been
Auto off ON or OFF
removed and stop the airflow. Clinician Mode

Detecting mask removal and

stopping the airflow will take

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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.

If “Backlight” ON is selected, the

screen will stay on all the time.

Alternatively, the backlight can be

set to automatically turn off after


Patient Mode
Backlight ON,15,30,45,60 15, 30, 45 or 60 seconds.
Clinician Mode
Note: Regardless of the backlight

setting, the green power LED is

always illuminated, as long as

power is applied to the Machine.

This feature is not currently used.

When this function is set up and

connected, the device can

automatically connect via WIFI to Patient Mode


WIFI setting Off/on
upload treatment data to a Clinician Mode
remote server, so that medical

staff can learn about treatment

therapy use.

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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 ON
ON.
Clinician Mode

Compliance Use is not reset.

Display the software version of Patient Mode


Version
the equipment. Clinician Mode

Select Yes, to start the cleaning

cycle. Before running the clean


Patient Mode
Clean Yes or No cycle, please refer to section
Clinician Mode
8.3.4 of this User Manual for

detailed instructions.

4.9 Data output

1. Ensure that the supplied USB memory flash drive is inserted into the rear of the Machine.

2. In the "System" menu, press the control dial to select "Output".

3. After the copy process has been completed, the CPAP Machine prompts “Copy completed,
exit”. Press the control dial button to complete this process.

The daily usage data files will be saved to the ”HEALDATA” folder of the USB memory flash drive.
Note: Do not remove the USB memory flash drive during the data output process.

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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. It is not intended for use with patients whose upper airways have been bypassed.

5.2 Specifications

 Working voltage: 24VDC

 Water tank volume: 270ml

 Maximum working pressure: 30cmH2O

 Air supply pressure range: 1-30cmH2O

 Working environment range: 5℃ - 35℃

 Range of input air temperature: 5℃ - 35℃

 Transmitted air temperature: no higher than 37℃ (as recommended)

 Statically humidified water temperature range: 35℃ - 45 (±5)℃

 Preheat time: 5 minutes from 23℃ to 45℃

 Heating time: When humidifier is at level 1, it takes 5 minutes to heat from 23℃ to
45℃. In level 2, it takes 5 minutes to heat from 23℃ to 55℃. In level 3, it takes 7
minutes to heat from 23℃ to 65℃.In level 4, it takes 10 minutes to heat from 23℃ to
75℃. In level 5, it takes 15 minutes to heat from 23℃ to 85℃.

 Protection against over-hot heating plate: 125±10℃

 Humidification ability: Under the premise of a flow rate of 20 to 40 L/min, it is more


than 10 mg/L. If the flow rate exceeds 40 L/min, the humidification ability cannot be
guaranteed for more than 10 mg/L.

 Recommended flow rate range: 20-40L/min

 Maximum leak: less than 20ml/min (maximum working pressure: 30cmH2O)

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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
as to prevent breeding of bacteria.

 When filling the water tank, it should first be removed from the humidifier. After the tank
is emptied after use, ensure the tank is dry before re-inserting to the humidifier.

 Do not overfill the water chamber as water may backflow into the Machine, damaging
the motor or other components.

 It is necessary to regularly check if there is any sign of damage or wear on the heating
humidifier. If damage is detected do not use the humidification function and contact your
service provider before using it again.

 When removing the water tank after use, it is important to remember the base plate will
be hot and to take precautions to avoid burning yourself.

 Do not use a humidifier or water chamber or humidifier that has not been designed for
this unit.

 Certain unpredictable risks may arise when the equipment uses externally connected
humidifier or its humidifier is connected to other CPAP Machine.

 The use of humidifier beyond the specified ambient temperature and humidity may affect
the humidification performance.

 When the humidifier is exposed to electric cautery, electro surgery, defibrillation, X-ray
(γ-ray), infrared radiation, and transient electromagnetic field (such as MRI and radio
disturbance), it may affect the normal working of the temperature sensor in it, and
eventually the humidification ability of the device.

 The output hose of the heating humidifier should be lower than the user as much as
possible to prevent the condensate within hose from flowing backward into the face
mask.

 It is not recommended to use the humidifier if the room temperature exceeds the
maximum temperature specifications.

Tip: If the Machine is to be used without the humidifier, the humidifier setting must be set to

OFF in the [Set] > [Param] menu, otherwise an alert message will occur after 40 seconds.

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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.

The manufacturer shall strictly keep those collected data confidential and shall not use them
for any commercial purpose related to a third party.

Note: This feature is not currently available in Australia.

If this feature becomes available in the future, details will be provided on our website.
Purchasers of this equipment and subscribers of our support services will be notified of
available options.

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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.

If power is disconnected from the Machine during use (Eg. A power cut), 2 beeps will sound,

followed by a 15 second pause. This will continue until power has been restored, or until the

internal device power has been exhausted.

7.2 Alert messages

Name Alert description Alert principle Handling measures

A sensor detects rotation

of the turbine rotor. If Immediately disconnect


The turbine blower /
Turbine rotation is not detected from the power and contact
motor stops working
within a certain period of your service provider.

time, an alert will be given.

When the temperature of

The temperature in heater element is over Immediately disconnect


Heating
heating humidifier 90℃ for more than 10 from the power and contact
humidifier
becomes too high seconds, an alert will be your service provider.

given.

If the machine is to be Disconnect the power, wait


Humidifier Humidifier is
used without the for 30 seconds. Before
fault disconnected
humidifier connected, it trying again, turn the

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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 The pressure sensor reads a negative value for run the Machine again. If

sensor fails 30 seconds or more, an the problem persists,

alert will be given. immediately disconnect

from the power and contact

your service provider.

Disconnect the power

supply, wait for 1 minute,

The flow sensor reads then re-apply the power and

error data for over 30 run the Machine again. If


Flow sensor The flow sensor fails
seconds, an alert will be the problem persists,

given. immediately disconnect

from the power and contact

your service provider.

If the pressure sensor

detects the hose pressure


The air flow output Immediately disconnect
High- is over 35cmH20 for 6
pressure exceeds from the power and contact
pressure seconds or more, an alert
35cmH20 your service provider.
will be given.

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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 and the face mask is
on
the CPAP Machine be given. correctly worn; Mask leaks

should be under 60l/m

if the problem persists,

contact your service

provider.

Check if the hose or face


The flow in the air
The flow sensor reads an mask is blocked; ensure the
outlet tubing
incorrect value for more hose is not crushed or bent.
Tubing block becomes nearly 0
than 30 seconds, an alert If problem persists, contact
due to
will be given. your service provider.
obstruction/blockage

7.3 Alert Suspension

If an alert is shown or heard, press the dial button during the alert to suspend it.

If the problem is not rectified within 30 seconds, the alert reminder will reoccur.

If you cannot resolve the alert, please contact your equipment provider for assistance.

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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

maintenance schedule:

• Clean the equipment, mask and hose before the initial use, then weekly;

• Empty any remaining water in the water tank each morning and clean the tank
thoroughly at least once per week to prevent the growth of bacteria;

• Check and clean the air filter once a month and replace it every six months;

• Replace the face mask and hose every 6-12 months or as required.

8.3 Cleaning method

8.3.1 Cleaning of CPAP machine and hose

Disconnect the equipment from the power supply before cleaning it or carrying out regular

maintenance.

Clean the front panel and exterior enclosure with soft damp cloth, moistened with warm water or

mild disinfectant or CPAP cleaning wipes. Dry the equipment completely before inserting the

power connection.

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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. Rinse with clean water, then wipe clean the components, and air dry.

After each clean, check the seal of the water tank is intact.

8.3.3 Air filter cleaning and replacement

The air filter should be cleaned in warm water and mild disinfectant, and the disinfectant

residue should be completely washed away. The filter should be completely dried before being

returned to the Machine. If the air filter is damaged in any way, please replace it immediately.

1. Disconnect the power supply of equipment.

2. Remove the filter cover.

3. Squeeze the middle part of the filter to remove it.

4. Check the cleanliness and completeness of the filter.

5. Clean the filter with warm water mixed with neutral disinfectant, wash it with water to

remove the disinfectant residue, completely dry the filter and then re-fix it; or change

the filter upon finding any damage.

Attention: Never install a wet/damp filter into the Machine. We recommend you clean the filter

in the morning and alternate with a spare filter to ensure adequate drying time for cleaned filter.

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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.

• Ensure the CPAP Machine is in a well-ventilated environment during cleaning.

• Do not power off the Machine during cleaning.

1. Remove the CPAP Machine inlet cover/filter.

2. Install the ozone circulation joint.

3. Remove, empty and reinsert the water tank.

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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. “Cleaning” will be

displayed on the screen, together with a progress percentage indication.

6. The cleaning cycle will finish once the display shows 100%.

7. Remove the hose and ozone circulation joint, then refit the air inlet cover/filter.

8. Press the control dial button to blow 10 minutes of fresh room air through the hose and

Machine to remove any residual ozone odor.

9. After 10 minutes, the Machine will stop blowing air.

10. Turn the control dial and press to [Exit].

11. Re-attach your mask to the hose and wait 2 hours before selecting [Treat] to begin CPAP

therapy.

If you find the fresh clean smell unpleasant, run the Machine in Treat Mode to blow more air

through the system.

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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.

9.2 Transportation

After being packed into the case, the CPAP Machine can be transported in a common way, but
should be protected from moisture, sunlight and shock during the process.

Important: When travelling with the Machine, ensure the water tank is completely dry before
packing up your Machine.

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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

No AC Power. Check wall socket is switched on and the AC

Power Supply Cord is firmly plugged in.

Check the fault is not with the power socket

by plugging in a lamp or other device.

The equipment stops


Check with your electricity service provider in
working, or;
case there is a power outage in your area.

Check if green LED is lit on the front of the


Power Supply Adaptor
There is no display, or; Machine. Re-insert DC plug firmly in back
is not inserted into the
of Machine.
back of the Machine.

Check if the blue LED is showing on the


Power Supply Adaptor
Power Supply Adaptor. Try in another wall
The green LED is not lit has failed.
socket.
on the front of the

Machine.
Power Supply Adaptor

faulty.

Discontinue use and contact your equipment


Power cord damaged
provider.
or equipment failure.

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Regulate the room temperature and keep


The equipment is
The equipment the equipment away from direct sunlight and
close to heater or in
temperature is heating devices.
bright sunshine or it is
excessively high If the error persists, contact your equipment
a hot day.
provider.

The device is

damaged after falling


Remove the power supply and move the
onto the ground or
Screen not displaying equipment into an environment with low
being water affected,
correctly electromagnetic interference. If the error
or affected by strong
persists, contact your equipment provider.
electromagnetic

interference.

Adjust the headgear or consider alternative


The face mask is not
mask options
properly adjusted or
The contact between
incorrect sizing, or Ensure appropriate hygiene protocol is
the face mask and the
skin irritation is caused adhered to as per cleaning instructions
skin causes skin
due to the raw included with the mask.
irritation or allergy
material or cleanliness
If the problem persists, stop use and contact
of the face mask.
your equipment provider.

Adjust the headgear properly or consider

alternative mask options. If you are new to


It feels uncomfortable The face mask is
CPAP therapy, practice first. Refer to the
when wearing the face incorrectly worn or of
included support brochure for advice.
mask an incorrect size
If the problem persists, contact your

equipment provider.

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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.

Check the display shows [Treat] on the


Airflow will not start.
screen.
The equipment works,

but does not achieve Airflow will not Auto Make sure Auto On is set to ON in the setup
the desired results. Start within 15 secs. menu.

Airflow will not Auto Make sure the Auto Off is ON in the set up

Stop after 15 secs. menu.

Reduce the humidifier setting to a lower

number in the [Set] > [Param] menu or set


Too much moisture in
humidifier to off.
the hose or mask.
Consider using an optional hose cover or

heated hose.

If the error cannot be resolved immediately, please discontinue use and contact your

equipment provider.

Warning: The Machine can only be repaired by qualified professionals.

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Chapter 11 Technical information

11.1 Parameters

11.1.1 Default C2 Machine Settings


• CPAP Mode

• CPAP: 10cmH20

• Humidifier: 2

• Pre-Heat: Off

• Comf: Off

• Auto on: On

• Auto off: On

• Ramp time: 10 minutes

• Ramp start: 4cmH20

• Backlight: 15 seconds

• Language: English

• Time and Date: Australian Eastern Standard Time (AEST = UTC+10h)

11.1.2 Default C5 Machine Settings


• Auto-CPAP Mode

• Max: 16cmH20

• Min: 6cmH20

• Humidifier: 2

• Pre-Heat: Off

• Comf: Off

• Auto on: On

• Auto off: On

• Ramp time: Off

• Ramp start: 4cmH20

• Backlight: 15 seconds

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• 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 ~ 35ºC -10ºC ~ 55ºC

Relative humidity 15% ~ 95% (non-condensate) 15% ~ 95% (non-condensate)

Atmospheric pressure 83~102kPa (5,600 feet above

the sea level)

11.1.5 Physical and electrical parameters

Parameter Value

Outer dimensions 28.8cm L x 20.2cm W x 8.4cm H

Weight 1.9kg

AC power supply 100 ~ 240VAC,50/60 Hz

AC 1.5A (max)

DC 2.5A (max)

Fuse rating T3.15A 250V, interrupting rating:100A

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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 helium oxide

Extreme environment statement:

When the environment and power supply (or gas supply) exceed the extreme values in the

following ranges, the change of one parameter and keeping of other parameters within the

normal ranges will severely affect the equipment performance, and even cause certain harm to

the user.

—— Ambient temperature range: 5℃-35℃;

—— Relative humidity range: 15% - 95%;

—— Atmospheric pressure range: 83 ~ 102kPa;

—— AC power voltage: -15% - +10% of rated voltage;

—— DC power voltage: -15% - +25% of rated voltage.

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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.

Warning:Don’t use near active HF surgical equipment and the RF shielded room of an ME
system for magnetic resonance imaging, where the intensity of EM disturbances is high.

Warning: Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.

Warning: Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.

Warning:Portable RF communications equipment (including peripherals such as antenna


cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of
this equipment including cables specified by the manufacturer, otherwise, degradation of the
performance of this equipment could result.

The performance of these Sleep Apnea Therapy Devices that was determined to be “The
display works normally, device runs without trouble, and the pressure output is normal” and a
description of what the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or

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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 Not Applicable

IEC 61000-3-2

Voltage fluctuations/ flicker Not Applicable

emissions

IEC 61000-3-3

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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 ±2 kV for power supply lines

transient/burst
±1 kV signal input/output Not Applicable

IEC 61000-4-4
100 kHz repetition frequency 100 kHz repetition frequency

Surge ±0.5 kV, ±1 kV differential ±0.5 kV, ±1 kV differential mode

mode
IEC 61000-4-5 Not Applicable

±0.5 kV, ±1 kV, ±2 kV common

mode

Voltage dips, short 0 % UT; 0,5 cycle. At 0°, 45°, 0 % UT; 0,5 cycle. At 0°, 45°, 90°, 135°,

interruptions and voltage 90°, 135°, 180°, 225°, 270° 180°, 225°, 270° and 315°.

variations on power supply and 315°.


0 % UT; 1 cycle and 70 % UT; 25/30
input lines
0 % UT; 1 cycle and 70 % UT; cycles; Single phase: at 0°.

IEC 61000-4-11 25/30 cycles; Single phase: at


0 % UT; 250/300 cycle
0°.

0 % UT; 250/300 cycle

Power frequency magnetic 30 A/m 30 A/m

field
50Hz/60Hz 50Hz/60Hz

IEC 61000-4-8

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Conduced RF 3V 3V

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

Radiated RF 10 V/m 10 V/m

IEC61000-4-3 80 MHz – 2,7 GHz 80 MHz – 2,7 GHz

80 % AM at 1 kHz 80 % AM at 1 kHz

NOTE UT is the A.C. mains voltage prior to application of the test level.

Table 3

Guidance and manufacturer’s declaration - electromagnetic Immunity

Radiated RF Test Band Service Modulation Modulation Distance IMMUNITY

(W)
IEC61000-4-3 Frequency (MHz) (m) TEST

LEVEL
(Test (MHz)
specifications (V/m)

for
385 380 – TETRA Pulse 1,8 0.3 27
ENCLOSURE
390 400
PORT modulation

IMMUNITY to
18 Hz

RF wireless
450 380 – GMRS FM 2 0.3 28
communicatio
390 460,
ns equipment) ± 5 kHz

FRS 460 deviation

1 kHz sine

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User Manual MK/YF38-07 – V2.02CS

710 704 – LTE Pulse 0,2 0.3 9

787 Band 13,


745 modulation

17
780 217 Hz

810 800 – GSM Pulse 2 0.3 28

960 800/900,
870 modulation
TETRA
930 18 Hz
800,

iDEN

820,

CDMA

850,

LTE
Band 5

1720 1 700 GSM Pulse 2 0.3 28


– 1800;
1845 modulation
1 990 CDMA
1970 217 Hz
1900;

GSM
1900;

DECT;

LTE
Band 1,

3,

4, 25;
UMTS

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2450 2 400 Bluetooth Pulse 2 0.3 28

– ,
modulation

2 570 WLAN,
217 Hz

802.11
b/g/n,

RFID
2450,

LTE

Band 7

5240 5 100 WLAN Pulse 0,2 0.3 9

– 802.11
5240 modulation

5 800 a/n
5785 217 Hz

11.3.3 RF information

For WIFI For BLE

Operating Frequency: 2400~2483.5MHz Operating Frequency: 2400~2483.5MHz

Max. Transmitter Power: 17.66dBm Max. Transmitter Power: 0.18dBm

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User Manual MK/YF38-07 – V2.02CS

Appendix 1: Model comparison table

Note:●Standard
C2 C5
○ Optional - Not Available

CPAP ● ●

Mode AUTOCPAP - ●

BPAP - -

Minimum Pressure 4cmH2O 4cmH2O

Maximum Pressure 20cmH2O 20cmH2O

Comfort Level ● ●
Therapeutic
Effects
45 Minute Ramp ● ●

Heated Humidifier ● ●

Pre-Heat ● ●

Auto airflow Start ● ●

Auto Airflow Stop ● ●


Extended
Features
Wi-Fi ● ●

Ozone Cleaning ● ●

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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

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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: [email protected]

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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