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User Manual

MK/YF38-07 – V2.01CS

© 2019 All Rights Reserved

Page 16 of 60

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

cmH

2

O

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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Содержание SleepZone C2

Страница 1: ...User Manual MK YF38 07 V2 01CS 2019 All Rights Reserved Page 1 of 60 User Manual Sleep Apnea Therapy Devices Models C2 CPAP C5 AUTO CPAP ...

Страница 2: ...User Manual MK YF38 07 V2 01CS 2019 All Rights Reserved Page 2 of 60 This page intentionally left blank ...

Страница 3: ...TENTIAL 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...

Страница 4: ...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 3...

Страница 5: ...ING 46 CHAPTER 11 TECHNICAL INFORMATION 49 11 1 PARAMETERS 49 11 1 1 DEFAULT C2 CPAP MACHINE SETTINGS 49 11 1 2 DEFAULT C5 AUTO CPAP 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 TEC...

Страница 6: ...comme 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 infri...

Страница 7: ...ovide 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 CPAP and C5 AUTO 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...

Страница 8: ...et 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 ...

Страница 9: ...y 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 equip...

Страница 10: ...nvironment 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 obje...

Страница 11: ...ipment 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 tr...

Страница 12: ... 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 ...

Страница 13: ... 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 connect...

Страница 14: ... the dial clockwise or counterclockwise to scroll through the screen display increase the value of selected parameter by rotating the dial clockwise and decrease it by rotating the dial counterclockwise Colour Display Displays settings and real time data including working pressure and air leakage Power LED Green light indicates the Machine is powered When not lit it indicated the Machine is discon...

Страница 15: ...normal household dust and pollen the filter cover is designed to keep the filter in place and should not be blocked at any time Humidifier Lid Release button Press the button to allow the humidifier lid to be opened upwards and allow the removal of the water tank Water tank Inside Humidifier The water tank can be removed and filled with distilled water for later use The amount of water should be l...

Страница 16: ...y 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 careful...

Страница 17: ...s 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 Hot surface ...

Страница 18: ...d 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 C...

Страница 19: ...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 ...

Страница 20: ... 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 ...

Страница 21: ...nector 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 humidifi...

Страница 22: ...or 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 head...

Страница 23: ...l 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 ...

Страница 24: ... 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 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...

Страница 25: ...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...

Страница 26: ... 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 Ve...

Страница 27: ...k 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...

Страница 28: ...u 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 Rota...

Страница 29: ...yed 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 start...

Страница 30: ...ve airway pressure as per the airway obstruction state Clinician Mode CPAP 4 20cmH20 Select the Treatment Pressure based on the patient s prescription This will be one value between 4cmH20 and 20cmH20 in 0 5cmH20 increments Clinician Mode Max CPAP 4 20cmH20 Set the upper pressure limit for automatic CPAP ventilation Clinician Mode Min CPAP 4 20cmH20 Set the lower pressure limit for automatic CPAP ...

Страница 31: ...4cmH2O CPAP Pressure 4cmH20 min CPAP pressure 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 Pressure has been reached CPAP Mode only or b The min CPAP pressure has been reached Auto CPAP Mode only Stop and restart the Machine to begin the Ramp time again Patient Mode Clinician Mode Humidi...

Страница 32: ...ent Patient Mode Clinician Mode Auto on ON or OFF 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 through the connected mask is detected If Auto on function is turned off The Machine will not automatically start Patient Mode Clinician Mode Auto off ON or OFF If Auto off function is turned on...

Страница 33: ...lected the screen will stay on all the time Alternatively the backlight can be set to automatically turn off after 15 30 45 or 60 seconds Note Regardless of the backlight setting the green power LED is always illuminated as long as power is applied to the Machine Patient Mode Clinician Mode WIFI setting Off on This feature is not currently used When this function is set up and connected the device...

Страница 34: ...cle Before running the clean cycle please refer to section 8 3 4 of this User Manual for detailed instructions Patient Mode Clinician Mode 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 Pres...

Страница 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 lev...

Страница 36: ...o 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 humid...

Страница 37: ...reatment 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...

Страница 38: ... messages Name Alert description Alert principle Handling measures Turbine The turbine blower motor stops working A sensor detects rotation of the turbine rotor If rotation is not detected within a certain period of time an alert will be given Immediately disconnect from the power and contact your service provider Heating humidifier The temperature in heating humidifier becomes too high When the t...

Страница 39: ... run the Machine again If the problem persists immediately disconnect from the power and contact your service provider Flow sensor The flow sensor fails The flow sensor reads error data for over 30 seconds an alert will be given Disconnect the power supply wait for 1 minute then re apply the power and run the Machine again If the problem persists immediately disconnect from the power and contact y...

Страница 40: ...blem persists contact your service provider Tubing block The flow in the air outlet tubing becomes nearly 0 due to obstruction blockage The flow sensor reads an incorrect value for more than 30 seconds an alert will be given Check if the hose or face mask is blocked ensure the hose is not crushed or bent If problem persists contact your service provider 7 3 Alert Suspension If an alert is shown or...

Страница 41: ...nce 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...

Страница 42: ...eaned 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 c...

Страница 43: ...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 ...

Страница 44: ...ogress 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...

Страница 45: ...t 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 ...

Страница 46: ... Power Supply Cord is firmly plugged in Check the fault is not with the power socket by plugging in a lamp or other device Check with your electricity service provider in case there is a power outage in your area Power Supply Adaptor is not inserted into the back of the Machine Power Supply Adaptor has failed Check if green LED is lit on the front of the Machine Re insert DC plug firmly in back of...

Страница 47: ... persists contact your equipment provider The contact between the face mask and the skin causes skin irritation or allergy The face mask is not properly adjusted or incorrect sizing or skin irritation is caused due to the raw material or cleanliness of the face mask Adjust the headgear or consider alternative mask options Ensure appropriate hygiene protocol is adhered to as per cleaning instructio...

Страница 48: ...l not start Check the display shows Treat on the screen Airflow will not Auto Start within 15 secs Make sure Auto On is set to ON in the setup menu Airflow will not Auto Stop after 15 secs Make sure the Auto Off is ON in the set up menu Too much moisture in the hose or mask Reduce the humidifier setting to a lower number in the Set Param menu or set humidifier to off Consider using an optional hos...

Страница 49: ...midifier 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 Auto CPAP 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 ...

Страница 50: ...logy 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...

Страница 51: ...de It can t be used in combustible anesthetics mixed with air or oxygen or 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 ...

Страница 52: ...ment 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 peripheral...

Страница 53: ... Analysis and Troubleshooting 11 3 2 Technical description Table 1 Guidance and manufacturer s declaration electromagnetic emissions Emissions test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000 3 2 Not Applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not Applicable ...

Страница 54: ...ion frequency 2 kV for power supply lines Not Applicable 100 kHz repetition frequency Surge IEC 61000 4 5 0 5 kV 1 kV differential mode 0 5 kV 1 kV 2 kV common mode 0 5 kV 1 kV differential mode Not Applicable Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Singl...

Страница 55: ... GHz 80 AM at 1 kHz 10 V m 80 MHz 2 7 GHz 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 IEC61000 4 3 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communicatio ns equipment Test Frequency MHz Band MHz Service Modulation Modulation W Distance m IMMUNITY TEST...

Страница 56: ...787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1720 1 700 1 990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217 Hz 2 0 3 28 1845 1970 ...

Страница 57: ...1 b g n RFID 2450 LTE Band 7 Pulse modulation 217 Hz 2 0 3 28 5240 5 100 5 800 WLAN 802 11 a n Pulse modulation 217 Hz 0 2 0 3 9 5240 5785 11 3 3 RF information For WIFI Operating Frequency 2400 2483 5MHz Max Transmitter Power 17 66dBm For BLE Operating Frequency 2400 2483 5MHz Max Transmitter Power 0 18dBm ...

Страница 58: ...rison table Note Standard Optional Not Available C2 C5 Mode CPAP AUTOCPAP BPAP Therapeutic Effects Minimum Pressure 4cmH2O 4cmH2O Maximum Pressure 20cmH2O 20cmH2O Comfort Level 45 Minute Ramp Heated Humidifier Pre Heat Extended Features Auto airflow Start Auto Airflow Stop Wi Fi Ozone Cleaning ...

Страница 59: ...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 ...

Страница 60: ...opment Co Ltd Room 101 102 North 1st Floor Superstar Enterprise Center No 8 Lujing Road High Tech Zone Changsha Hunan P R China 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 ...

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