Resvent RXiBreeze User Manual Download Page 41

Page: 41 / 42

Issue date: Decembe., 2020

H-4000-000002-00 V5.1

Contact information

Resvent Medical Technology Co., Ltd.

BC601, BC602, Gaoxinqi Factory, District 67, Xingdong Community,Xin’an

Street, Bao’an District, 518100 Shenzhen, PEOPLE'S REPUBLIC OF

CHINA
Tel: 0086-755-23027370

Fax: 0086-755-23027370

http://www.resvent.com

Summary of Contents for RXiBreeze

Page 1: ...User Manual PAP System RXiBreeze PAP System ...

Page 2: ...on 2 5 Symbol 6 6 System Contents 7 7 System Overview 9 8 Navigating the Device Screens 14 9 Operation 14 10 Device Alert 22 11 Troubleshooting 26 12 Cleaning and Maintaining 27 13 Maintenance 31 14 Storage and Disposal 31 14 1 Storage 31 15 Specification 32 16 EMC Declaration 34 ...

Page 3: ...e therapy for the treatment of Obstructive Sleep Apnea OSA in spontaneously breathing patients weighting over 30kg 66lbs It is for use in the home hospital or institutional environment 3 Contraindications When assessing the relative risks and benefits of using this equipment the clinician should understand that this device can deliver pressures up to 20 cmH2O In the event of certain fault conditio...

Page 4: ...ting enough fresh air will not be provided through the mask If you are using a full face mask a mask covering both your mouth and your nose the mask must be equipped with a safety entrainment valve When using oxygen with this system always make sure that the device is turned on and airflow generated before the oxygen supply is turned on Always turn the oxygen supply off before the device is turned...

Page 5: ... damage or signs of wear Discontinue use and replace if damaged To avoid electrical shock always unplug the power cord from the wall outlet before cleaning the device DO NOT immerse the device in any fluids Be sure to route the power cord to the outlet in a way that will prevent the cord from being tripped over or interfered with by chairs or other furniture This device is activated when the power...

Page 6: ...very hot or very cold temperatures allow it to adjust to room temperature operating temperature before starting therapy Do not operate the device outside of the operating temperature range shown in the Specifications Do not use extension cords with this device Make sure the filter area on the side of the device is not blocked by bedding curtains or other items Air must flow freely around the devic...

Page 7: ...our supplier immediately Because it may cause allergic reactions Please periodically reassess the setting s of the therapy for effectiveness Never install a wet filter into the device You must ensure sufficient drying time for the cleaned filter Empty the water tank before packing or moving the device FCC Caution Any Changes or modifications not expressly approved by the party responsible for comp...

Page 8: ...rent Temperature limit Humidity limitation Atmospheric pressure limitation Follow instructions for use It is mandatory action to read the instructions for use Separate collection for electrical and electronic equipment according to WEEE Directive 2012 19 EU Class II double or reinforced insulation Prevent solid foreign matters with a diameter of not less than 12 5mm and prevent vertical dripping w...

Page 9: ...not roll Fragile handle with care Keep dry Keep away from sunlight Stacking limit by 8 Recyclable materials U S Federal law restricts this device to sale by or on the order of a physician or any other practitioner licensed by state law Unique device identifier Identifies unit has been registered as a radio device 6 System Contents Your CPAP system may include the following items CPAP Device Power ...

Page 10: ...RXiBreeze PAP System User Manual 8 User Manual Nasal mask or full face mask Note If any of these items are missing please contact your home care provider ...

Page 11: ...d Access Door This door lifts open for access to SD card 10 Air Inlet Port Inlet for room air 11 Filter Cotton Cover Open the filter cotton cover to place or change the filter cotton CPAP often is the best treatment for obstructive sleep apnoea This CAPA system is an electronic driven microprocessor controlled CAPA device that provides mechanical ventilation to a patient during use This CPAP treat...

Page 12: ...make sure that the power cable is accessible because removing power is the only way to turn off the device CAUTION Make sure the filter area on the side of the device is not blocked by bedding curtains or other items Air must flow freely around the device for the system to work properly Do not place the device directly onto carpet fabric or other flammable materials Do not place the device in or o...

Page 13: ...ontact with the DC in connector when it was broken Please avoid arcing wiggling or dropping the power supply on hard surfaces Please periodically inspect electrical cords and cables for damage or signs of wear and to discontinue use and replace if damaged Please first check the DC connector could be used normal and not breaking free Never place the power cord around the neck Do not use any small p...

Page 14: ...and the correct use of the method please refer to the mask manual WARNING If you are using a full face mask a mask covering both your mouth and your nose the mask must be equipped with a safety entrainment valve If multiple users share the same equipment use low resistance and bacteria filtered cotton between the equipment and the tube Note The selected mask breathing tube shall meet the performan...

Page 15: ...vel for safe operation The fill line indicates 2 3 water level for safe operation The fill line indicates the maximum water level for safe operation CAUTION Use only room temperature distilled water or purified water Do not fill the water tank above the maximum fill line If the water tank is overfilled water may leak into the therapy device humidifier or onto your furniture Damage to the humidifie...

Page 16: ...econd followed by the patient standby screen See Figure 1 Note Boot buzzer should be beep If not you can t use the equipment and then contact the supplier for inspection 2 Put on your mask assembly Refer to the instructions supplied with the mask 3 Press the Therapy On Off key on top of the device to turn on airflow and begin therapy The screen will display to patient therapy clean interface see F...

Page 17: ...th 3 months 6 months 1 year 5 Humidity Set humidifier level to enhance patient comfort of respiration Option Auto OFF 1 8 Default 3 Note 1 The humidity level only can be set when the water in humidifier exceeds the minimum water level for safe operation 2 The option Auto is not available in the RXiBreeze 20C 6 Mask fit Mask fit feature allows you to check the fit of your mask prior to starting the...

Page 18: ...ription 1 The current therapy mode 2 Display the alarm messages 3 Humidity adjustment shortcut key and humidity level Note The humidity level is available when the humidity function is on 4 Background breathing dynamic diagram 5 The current therapy pressure 6 The therapy parameters monitoring during therapy 7 Ramp time dynamic diagram Note Only available when the Ramp function is on 8 Work status ...

Page 19: ...t function is not available in the RXiBreeze 20C P Ramp Set the starting pressure of Ramp Setting Range 3 cmH2O Setting pressure 0 5 cmH2O increments Default 4 cmH2O Ramp Time Set the increase time from Ramp pressure to the setting therapy pressure Option 0 60 mins 5 mins increments Default 15 mins Note if Ramp Time sets to 0 min Ramp function will be off Auto Start Turn Auto Start function on or ...

Page 20: ...m Setting Press key in the Patient Standby interface to enter Patient Setting interface Figure4 Patient Setting Interface Icon Text Description Pressure Unit Set the pressure unit Option hPa cmH2O Default cmH2O Screen Brightness Adjust the Screen Brightness Option Auto 1 3 Default 2 Language Set the system interface language Option English Spanish French German Italian Portuguese Default English N...

Page 21: ...evice 2 The system date is required to reset on the first time start up when the device is restored the factory default settings Date Format Set the system date format Option YYYYMMDD MMDDYYYY DDMMYYYY Default YYYYMMDD Time Set the system time Note time setting can t be earlier than the latest time of the report in the device Alarm Clock Set the Alarm clock on or off and the alarm time Option ON O...

Page 22: ... and then no longer remind 3 Click Ignore the next day and next starting time will pop up reminder box About Display the device informaiton including system version serial number blower running time etc 9 2 5 Patient Report Menu Press info key in Patient Standby Interface to enter Patient Report Interface Figure5 Patient Report Interface Item Description Period Set the time interval covered by the...

Page 23: ...ovider Your home care provider may ask you to send the SD card to them for evaluation To remove the SD card 1 Stop therapy and open the SD card cover 2 Push in the SD card to release it Remove the SD card from the device Place the SD card in the protective folder and send it to your care provider Note 1 Do not remove the SD card from the device during therapy 2 Do not use the SD card for any other...

Page 24: ...terface on the device click search search for the WiFi signals nearby enter the WiFi list interface Click on an available Wifi enter the Wifi password input interface enter the correct password until Wifi connected successfully Sign of connection successful Wifi status is connected Wifi status icon is 9 2 7 2 Usage of Wifi module The method for the device to connect WiFi network is through APP or ...

Page 25: ...ta synchronization 2 Input the configuration on the SD card No action SD Card Removed Notification 1 No SD card in the device 2 SD card has been removed Reinsert functional SD card SD Card Full Please replace the SD Card Notification In Standby mode SD card storage space only 200M Replace the SD card or clean the data after export the data in the SD card SD card can t be written please unlock and ...

Page 26: ...r tank setting service life Click Confirm replace the water tank The filter expired please replace Notification In standby state the usage time exceed the filter setting service life Click Confirm replace the filter The mask expired please replace Notification In standby state the usage time exceed the mask setting service life Click Confirm replace the mask It is time for device maintenance Pleas...

Page 27: ...rt Type Possible Cause Action minutes usage with humidification RTC clock failure Reports may not be saved Alert1 RTC clock failure Please contact the supplier if you want reports be saved Note Some alert messages depend on the device model ...

Page 28: ...vice s power inlet If the problem continues to occur contact your home care provider Return both the device and power supply to your provider so they can determine if the problem is with the device or power supply Air is leaking from around my mask Mask may be fitted incorrectly Make sure your mask is fitted correctly See your mask user guide for fitting instructions or use the Mask Fit function t...

Page 29: ... continues contact your home care provider My water tank is leaking Water tank may not be assembled correctly Water tank may be damaged or cracked Check for damage and reassemble the water tank correctly Contact your care provider for a replacement Key exception non responsive or insensitive Program crashes or key misalignment Unplug the device Reapply power to the device If the problem continues ...

Page 30: ...sually cleaned at the end of the cleaning steps You should either repeat the relevant previous cleaning steps so that a visible soiled device is not used again 4 Wait about at lest 1 minutes for drying completely before plugging in the power cord 2 Disinfection 1 After the cleaning procedure use an 75 ethyl alcohol swab or cotton swab moistened with 75 ethyl alcohol to disinfect the device surface...

Page 31: ...xcess water and allow the component to air dry rather out of direct sunlight Note Failure to clean the component as indicated may result in inadequate disinfection 2 Disinfection WARNING The disinfection process must be carried out after cleaning process 1 After the cleaning procedure immerse the component in a water bath and make a solution of a 3 hydrogen peroxide Soak the components in the solu...

Page 32: ...mes when the device is operating Please check the air filter every 1 3 months clean or replace it if there are any holes or blockages by dirt or dust Note When you receive your device if the filter cotton is not installed you must install the filter cotton before using the device To install or replace the air filter please follow the below steps 1 Open the air filter cover 2 Place a filter cotton ...

Page 33: ...ance If you identify faulty parts during the function check please contact your authorized dealer immediately 14 Storage and Disposal 14 1 Storage 14 1 1 Storage Information Store the device under the prescribed ambient conditions 14 1 2 Storing the therapy device Switch off the therapy device Disconnect the therapy device from the power supply Clean the therapy device components and accessories S...

Page 34: ...rd Electromagnetic disturbances Requirements and tests ISO 80601 2 70 2020 Medical electrical equipment Part 2 70 Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment ISO 80601 2 74 2021 Medical electrical equipment Part 2 74 Particular requirements for basic safety and essential performance of respiratory humidifying equipment IEC60601...

Page 35: ...ure monitoring Accuracy 2 full scale reading 4 actual reading Flow Test pressure cmH2O 4 8 12 16 20 19mm breathing tubing Measured pressure at the patient connection port cmH2O 2 9 7 1 11 0 15 1 19 1 Average flow at the patient connection port L min 154 3 146 4 135 7 125 3 114 1 15mm breathing tubing Measured pressure at the patient connection port cmH2O 2 9 6 9 10 8 14 8 18 7 Average flow at the ...

Page 36: ...t transmitters and the CPAP system as recommended in form A 3 according to the maximum output power of the communications equipment Form A 1 Guidance and Declaration Electromagnetic Emissions Emissions test Compliance Electromagnetic environment guidance Radiated emissions CISPR11 Group 1 The CPAP system uses RF energy only for its internal function Therefore its RF emissions are very low and are ...

Page 37: ...2 kV line s to line s 1 kV line s to earth 2 kV Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 0 70 0 of UT 0 for 0 5 cycle Mains power quality should be that of a typical commercial or hospital environment 0 for 1 cycle 70 for 25 cycles 0 for 250 cycles Power frequ...

Page 38: ...s 5240MHz 5500MHz 5785MHz 9V m rms 10V m 80 AM at 1kHz 27V m PM at 18Hz 28V m FM 5 kHz deviation at 1kHz sine 9V m PM at 217 Hz 28V m PM at 18Hz 28V m PM at 217 Hz 28V m PM at 217 Hz 9V m PM at 217 Hz 80MHz to 800MHz d 1 2 800MHzto 2 5GHz d 2 3 Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation dist...

Page 39: ...F Communications Equipment and the CPAP system Rated maximum output power of transmitter W Separation distance in meters m according to frequency of the transmitter 150kHz 80MHz d 1 2 80MHz 800MH z d 1 2 800MHz 2 5GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 ...

Page 40: ...e correct Resvent shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing performance or use of this manual Contents of this manual are subject to change without prior notice Limited Warranty Resvent warrants that the system shall be free from defects of workmanship and materials and will perform in accordance with the product sp...

Page 41: ...ed H 4000 000002 00 V5 1 Contact information Resvent Medical Technology Co Ltd BC601 BC602 Gaoxinqi Factory District 67 Xingdong Community Xin an Street Bao an District 518100 Shenzhen PEOPLE S REPUBLIC OF CHINA Tel 0086 755 23027370 Fax 0086 755 23027370 http www resvent com ...

Page 42: ...maximum mark Close the lid and insert the chamber back 3 4 Lock the outlet onto back of device by turning outlet clockwise 5 Connect one side of the tube to the air outlet and mask at the other end Connect the power supply to the device Fit mask and press start button to initiate therapy 6 ...

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