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iBreeze CPAP Clinical Guide

3

Therapy On/Off Button(Starts and stops the airflow for therapy)

This way up at transport and storage

Fragile, handle with care

Keep dry at transport and storage

Stacking limitations

Recyclable materials

About the control panel

Symbol

Definition

Press to start/stop therapy.

Turn to navigate the menu and press to select an option.

Turn to adjust a selected option and press to save your change.

Press ramp to set ramp time quickly on standby interface.

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Содержание iBreeze 20A

Страница 1: ...CPAP Clinical Guide iBreeze 20C 20C Pro iBreeze 20A 20A Pro ...

Страница 2: ...se 1 3 Contraindications 1 4 Symbol Key 2 5 System Overview 4 6 Operation 5 7 Therapy Information 14 8 Device Alert 20 9 Troubleshooting 22 10 Cleaning and Maintaining 23 11 Maintenance 24 12 Storage and disposal 24 13 Specification 25 ...

Страница 3: ... complies with the applicable national standard and the manual requirements The product is used in accordance with the instruction for use 2 Intended use The iBreeze CPAP system delivery positive airway pressure therapy for the treatment of Obstructive Sleep Apnea OSA in spontaneously breathing patients weighting over 30kg 66lbs It is for use in the home or hospital institutional environment 3 Con...

Страница 4: ...th the provisions of the Council Directive 93 42 EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive European Authorized Representative Dispose according to Council Directive 2012 19 EU or WEEE Waste Electrical and Electronic Equipment Indicates the degree of protection against electric shock according to IEC 60601 1 Class II devices have double or re...

Страница 5: ... handle with care Keep dry at transport and storage Stacking limitations Recyclable materials About the control panel Symbol Definition Press to start stop therapy Turn to navigate the menu and press to select an option Turn to adjust a selected option and press to save your change Press ramp to set ramp time quickly on standby interface ...

Страница 6: ...t for room air 11 Filter Cotton Cover Open the filter cotton cover to place or change the filter cotton Navigating the Device Screens The User Interface UI on this device allows you to adjust the device settings and view information about your therapy The UI is comprised of the display screen and the control dial Rotate the control dial in either direction to scroll through the menu options on the...

Страница 7: ...Mode To access the Clinical Mode Press and hold both the control dial and the Ramp button on the device for three seconds The Home screen is displayed with an icon in the top right corner of the screen You are now in the Clinical Mode To exit the Clinical Mode Press and hold the dial and the Ramp button for three seconds 6 2 Clinical Standby Interface After accessing the clinical mode the clinical...

Страница 8: ... be set when the water is higher than the limit level in the humidifier 4 Mask fit Mask fit test In the selection of a new mask need to test the face mask to wear whether the occurrence of leakage In standby or therapy mode click on the mask fit test icon display mask fit test in process with the animation interface 5 Comfort Press Comfort key enter Clinical comfort setting interface 6 Setting Pre...

Страница 9: ...y enter Clinical comfort setting interface 6 The current therapy pressure 7 The settings parameters of the corresponding mode Please refer Chapter7 Therapy Information for more details 8 If blood oxygen saturation is present and connected the monitored blood oxygen saturation and pulse rate values are displayed in this area 9 Ramp time dynamic diagram Note Only Ramp function is turned on for Ramp ...

Страница 10: ...ment pressure to the target treatment pressure in the specified ramp time The minimum ramp time in auto ramp is 5 minutes However if sleep onset is not detected within 60 minutes the device will start to increase the pressure in the same manner still Auto ramp is available for all therapy modes iPR Intelligent pressure release is designed to make the therapy more comfortable by reducing the treatm...

Страница 11: ...tically sleep begins to start Ramp function awake do not start ramp function Option On OFF Default OFF 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 P Ramp Set the starting pressure of Ramp Setting Range 3 cmH2O Setting pressure 0 5 cmH2O increments Defa...

Страница 12: ... the system interface language Default English Chinese Default English Energy Saving Set the Energy Saving function on or off When Energy Saving is on the screen will be turned off automatically if there is no operation within 3 minutes in standby mode or 30 seconds in therapy mode If Energy Saving is off the screen is always on Option ON OFF Default ON Date Set the system date Note 1 Date setting...

Страница 13: ...Default OFF Note 1 Set the date of reminder will pop up reminder box first time to enter standby mode in the day of setting reminder day 2 Click OK to change the relevant accessories and then no longer remind 3 Click Ignore the next day and next starting time will pop up reminder box Mask Type Set the Mask type Option Full Face Nasal Pillow Default Nasal Info Menu When you set the info menu on the...

Страница 14: ...y base velocity 100L min trigger time is the set time 2 Mask vent holds blocked Alert level Alert1 Setting Mask vent holds blocked alert Option ON OFF Default OFF Alert limit the actual leak flow is less than 10lpm or 30 of the expected leak flow at present mask pressure and lasts longer than 60s 6 7 Clinical Information Interface Press information key in clinical standby interface to enter clinic...

Страница 15: ... pressure 95 The 95th percentile says that 95 of the time the variable eg pressure is at or below this amount Just the same during the remaining 5 of the time the variable is above that amount 8 Avg leak Avg Leakage Average of the 95th percentile values of leak during the selected period 9 RERA Respiratory Effort Related Arousals One day the average number of RERA events occurred in an hour of the...

Страница 16: ...tment pressure increases 1 cmH2O per day until the prescribed pressure is reached CPAP Mode Parameters Setting Parameter Description 1 Pressure Set the prescribed pressure throughout the therapy You can adjust this setting from 4 to 20 cmH2O The increment is 0 1 0 5 cmH2O 2 E COMP This feature reduces the therapy pressure setting for the first few days of operation and gradually increases this set...

Страница 17: ...ditions The initial default setting is 12 cmH2O You can adjust the setting from the P min setting to 20 cmH2O The increment is 0 1 0 5cmH2O 2 Pmin This feature sets lower limit of the treatment pressure in titration session The device operates in APAP mode during the titration session thus treatment pressure is adapted automatically according to the patient s conditions The initial default setting...

Страница 18: ...ys if the actual used days are less than seven P95 of the actual available days are used otherwise Pmin is used as the initial treatment pressure APAP Mode Parameters Setting Parameter Description 1 Pmax This feature sets upper limit of the treatment pressure The treatment pressure is adapted automatically according to the patient s conditions The initial default setting is 12 cmH2O You can adjust...

Страница 19: ...tomatically according to the patient s conditions The initial default setting is 12 cmH2O You can adjust the setting from the P min setting to 20 cmH2O The increment is 0 1 0 5cmH2O 2 Pmin This feature sets lower limit of the treatment pressure The treatment pressure is adapted automatically according to the patient s conditions The initial default setting is 6 cmH2O You can adjust the setting fro...

Страница 20: ...ntially No therapy adjustments are made in response to the other events Once in normal breathing again the treatment pressure reduces gradually By the automatic pressure adjustment method mentioned above the average treatment pressure resides in a relative lower level which offers a better therapy compliance This function is enabled in APAP APAPW Mode Apnea Apnea is defined as amplitude of the pat...

Страница 21: ...normal again pressure reduces gradually Flow Limitation As the upper airway starts to collapse the inspiratory portion of the airway waveform becomes flat which is a presymptom of snoring hypopnea and apnea The device recognizes this pattern and increases the treatment pressure accordingly When the breathing becomes normal again pressure reduces gradually RERA Respiratory effort related arousal is...

Страница 22: ...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 insert again Notification The SD card is read only and can t be writte...

Страница 23: ...ue Check the respiration tube or adjust therapy parameter setting High Respiratory Rate RR Alert 0 Respiratory Rate exceed the setting threshold value Check the respiration tube or adjust therapy parameter setting Low Respiratory Rate RR Alert 0 None Check the respiration tube or adjust therapy parameter setting Apnea Alert 1 An apnea is detected and exceeds the setting duration Check the respirat...

Страница 24: ...y be escaping through your mouth Increase the Humidity Level You may need a chin strap to keep your mouth closed or a full face mask Air pressure in my mask seems too high it feels like I am getting too much air Ramp may be turned off Use the Ramp Time option Air pressure in my mask seems too low it feels like I am not getting enough air Ramp may be in progress Wait for air pressure to build up or...

Страница 25: ...s 1 Unplug the device Wipe the outside of the device using a cloth slightly dampened with water and a mild detergent Let the device dry completely before plugging in the power cord 2 Inspect the device and all circuit parts for damage after cleaning Replace any damaged parts 10 2 Cleaning the Tube Water Tank Clean the flexible tube and water tank before first use Remove the flexible tube and water...

Страница 26: ...y an authorized dealer If the respiratory air humidifier is used as intended in accordance with these instructions for use it does not require any maintenance If you identify faulty parts during the function check please contact your authorized dealer immediately 12 Storage and disposal 12 1 Storage 12 1 1 Storage Information Store the device under the prescribed ambient conditions 12 1 2 Storing ...

Страница 27: ...quipment Part 2 70 Particular requirements for basic safety and essential performance of Sleep apnea breathing therapy equipment ISO 8185 2009 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems IEC 60601 1 11 2015 Medical electrical equipment Part 1 11 General requirements for basic safety and essential performance Collateral Standard Requi...

Страница 28: ...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 Inc warrants that the system shall be free from defects of workmanship and materials and will perform in accordance with the product specific...

Страница 29: ...Road Xinan street Baoan District Shenzhen 518100 P R China Factory Address Room 802 Building 2 Gaoxinqi Industrial Park phase II Liuxian No 1 Road Xinan street Baoan District Shenzhen 518100 P R China Tel 0755 23027370 Fax 0755 23027370 http www resvent com Issue date Sept 2017 2016 Resvent Medical Technology Co Ltd All rights reserved 4000 000040 00 V1 1 ...

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